Assemblies and tools for resheathing catheters

Abstract

An example assembly for resheathing an expandable tip of a catheter may include a resheath tool and a sheath. The resheath tool defines a tool lumen extending along a longitudinal tool axis. The resheath tool is configured to distally slide over the expandable tip of the catheter within the tool lumen and compress the expandable tip from an expanded configuration to a compressed configuration. The sheath is slidable proximally over the expandable tip while the expandable tip is held in the compressed configuration by the resheath tool. An example resheath tool may include a first tool portion. The resheath tool may further include a second tool portion removably securable to the first tool portion. The first tool portion and the second tool portion may define a tool lumen therebetween and extending along a longitudinal tool axis.

Description

Docket No.: A0012268W001 / 1216-158W001ASSEMBLIES AND TOOLS FOR RESHEATHING CATHETERSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to and the benefit of U.S. Provisional Application Serial No. 63 / 696,110, filed on September 18, 2024, which is incorporated herein by reference in its entirety.TECHNICAL FIELD

[0002] The present disclosure generally relates to resheathable catheters, and to assemblies and tools for resheathing catheters.BACKGROUND

[0003] A catheter may include an expandable distal portion, for example, a funnel. The expandable distal portion of the catheter may be configured to be introduced into a blood vessel and capture and / or remove an object in the blood vessel (e.g., a thrombus or a mechanical thrombectomy device).SUMMARY

[0004] In general, the present disclosure describes examples of resheath tools configured to slide over an expandable tip of a catheter to compress the expandable tip and allow a sheath to slide over the expandable tip of the catheter. In this manner, the disclosure describes assemblies including catheters that include a resheathable expandable tip. For example, the expandable tip may include a funnel, and the funnel may be configured to capture objects in a blood vessel. Thus, assemblies according to the present disclosure may be used for thrombectomy (e.g., to remove blood clots from a vessel of a peripheral vascular anatomy). Certain catheters include expandable tips (e.g., funnels) that can only be deployed a single time. For example, the expandable tip may be expandable only once, and may not be resheathable or reusable, or may be very cumbersome to resheathable and reuse.

[0005] In some examples, the present disclosure describes an example resheath tool configured to resheath (e.g., by collapsing) an expandable tip of a catheter from a deployed configuration (e.g., an expanded configuration) to a sheathed configuration (e.g., a compressed configuration). An example assembly may include the resheath tool and a sheath configured to receive and retain the expandable tip of the catheter in the sheathed configuration. The resheath tool may be used to resheath and retain at least the expandable tip of the catheter in the sheath after use. For reuse and redeployment, the catheter can be reintroduced in the sheath in theDocket No.: A0012268W001 / 1216-158W001 anatomy, and the sheath removed to permit the expandable tip of the catheter to expand from the sheathed configuration to the deployed configuration. Thus, assemblies and tools according to the present disclosure may be used to resheath catheters including expandable tips.

[0006] In some examples, an example assembly for resheathing an expandable tip of a catheter includes a resheath tool and a sheath. The resheath tool defines a tool lumen extending along a longitudinal tool axis. The resheath tool is configured to distally slide over the expandable tip of the catheter within the tool lumen and compress the expandable tip that is in an expanded configuration to a compressed configuration. The sheath is slidable proximally over the expandable tip while the expandable tip is held in the compressed configuration by the resheath tool.

[0007] In some examples, an example resheath tool includes a first tool portion. The resheath tool may further include a second tool portion removably securable to the first tool portion. The first tool portion and the second tool portion define a tool lumen therebetween and extending along a longitudinal tool axis.

[0008] In some examples, an example method includes sliding a resheath tool distally over an expandable tip of a catheter to compress the expandable tip that is in an expanded configuration to a compressed configuration. The method may further include sliding a sheath proximally over the expandable tip while the expandable tip is held in the compressed configuration by the resheath tool.

[0009] In some examples, an example kit includes a housing, the housing including a resheath tool and a sheath. The resheath tool defines a tool lumen extending along a longitudinal tool axis. The resheath tool is configured to distally slide over the expandable tip of the catheter within the tool lumen and compress the expandable tip that is in an expanded configuration to a compressed configuration. The sheath is slidable proximally over the expandable tip while the expandable tip is held in the compressed configuration by the resheath tool.

[0010] The details of one or more examples of the techniques of this disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0011] FIG. 1 is an unassembled view of an example assembly including a resheath tool and a sheath.

[0012] FIG. 2A is a side view of an example assembly in a first configuration including the resheath tool of FIG. 1 positioned proximal to an expandable tip of a catheter.Docket No.: A0012268W001 / 1216-158W001

[0013] FIG. 2B is a side view of the assembly of FIG. 2A in a second configuration with the resheath tool moved distally along the catheter toward the expandable tip.

[0014] FIG. 2C is a side view of the assembly of FIG. 2A in a third configuration with the resheath tool receiving the expandable tip in a compressed configuration.

[0015] FIG. 2D is a side view of the assembly of FIG. 2A in a fourth configuration with the sheath of FIG. 1 ready to be moved over a distal portion of the expandable tip in the compressed configuration.

[0016] FIG. 2E is a side view of the assembly of FIG. 2A in a fifth configuration with a proximal portion of the sheath receiving the distal portion of the expandable tip in the compressed configuration.

[0017] FIG. 2F is a side view of the assembly of FIG. 2A in a sixth configuration with the sheath and the resheath tool moved proximal of the expandable tip, with the sheath receiving the expandable tip in the compressed configuration.

[0018] FIG. 2G is a side view of the assembly of FIG. 2A in a seventh configuration with the resheath tool removed from the catheter, to leave the expanded tip in the compressed configuration and received in the sheath.

[0019] FIG. 3 A is a side view of an example sheath including a skived sheath portion.

[0020] FIG. 3B is a front view of the sheath of FIG. 3 A.

[0021] FIG. 4 is a side view of an example peelable resheath tool including a peel line and a slit.

[0022] FIG. 5A is a side view of an example resheath tool including a first portion and a second portion removably securable to the first portion in an unassembled configuration.

[0023] FIG. 5B is a front view of the resheath tool of FIG. 5 A in the unassembled configuration.

[0024] FIG. 6A is a side view of the resheath tool of FIG. 5 A in an assembled configuration.

[0025] FIG. 6B is a front view of the resheath tool of FIG. 6A in the assembled configuration.

[0026] FIG. 7A is a side view of an example sheath including a flared sheath portion.

[0027] FIG. 7B is a front view of the sheath of FIG. 7A.

[0028] FIG. 8 is a side view of an example flared resheath tool.

[0029] FIG. 9 is an example technique for resheathing an expandable tip of a catheter using an assembly including a resheath tool and a sheath.Docket No.: A0012268W001 / 1216-158W001DETAILED DESCRIPTION

[0030] The present disclosure generally relates to resheathable catheters, and to assemblies and tools for resheathing catheters. Certain catheters used to remove materials or objects from a patient’s anatomy include expandable tips (e.g., a funnel). The expandable tip is introduced into a vessel of the patient in a compressed configuration, then expanded to an expanded configuration at a target site. In some examples, a constraint is applied to the expandable tip to retain the expandable tip in the compressed configuration, and the expandable tip is configured to expand to the expanded configuration upon removal of the constraint. However, such catheters may not be reusable after deployment (e.g., re-insertable into a vessel) unless the expandable tip is returned to an initial compressed configuration. For example, a clinician may need to withdraw the catheter from the anatomy to clean material (e.g., thrombus) from the catheter, or may inadvertently withdraw the catheter. In such cases, the clinician may need to discard the catheter and use a new catheter. With the example techniques described in this disclosure, rather than discard and use a new catheter, the clinician may be able to reuse the same catheter.

[0031] Assemblies and tools according to the present disclosure may be used to resheath catheters, for example, to resheath expandable tips of catheters. An example assembly for resheathing an expandable tip of a catheter includes a resheath tool and a sheath. The resheath tool defines a tool lumen extending along a longitudinal tool axis. The resheath tool is configured to distally slide over the expandable tip of the catheter within the tool lumen and compress the expandable tip that is in an expanded configuration to a compressed configuration. The sheath is slidable proximally over the expandable tip while the expandable tip is held in the compressed configuration by the resheath tool. Thus, the resheath tool may facilitate compressing the expandable tip to return the expandable tip to a compressed configuration from an expanded configuration.

[0032] Further, the sheath may receive and retain the expandable tip in the compressed configuration, and the resheath tool may be removed from the catheter to leave the expandable tip held by the sheath in the compressed configuration. Accordingly, the expandable tip in the compressed configuration is ready for reuse, for example, reintroduction in anatomy of the patient. After reintroduction and positioning of the expandable tip at a target site, the sheath may be removed to allow the expandable tip to expand from the compressed configuration to an expanded configuration (e.g., to capture and / or remove material). In some examples, assemblies and tools according to the present disclosure may be used to resheath thrombectomy catheters for reuse.

[0033] FIG. 1 is an unassembled view of an example assembly 10 including a resheath tool12 and a sheath 14. Assembly 10 may be configured to resheath an expandable tip of a catheterDocket No.: A0012268W001 / 1216-158W001(as described with reference to FIGS. 2 A to 2G). Resheath tool 12 defines a tool lumen 16 extending along a longitudinal tool axis T.

[0034] One or both of resheath tool 12 or sheath 14 may include a polymer, for example, a same or a different polymer from each other. In some examples, the polymer includes a biocompatible or sterilizable polymer. In some examples, the polymer includes one or more of a polystyrene, a polypropylene, a polyvinyl chloride, an elastomer, or a fluoropolymer. In some examples, the polymer includes polytetrafluoroethylene. For example, one or both of resheath tool 12 or sheath 14 may include polytetrafluoroethylene. In some examples, one or both of resheath tool 12 or sheath 14 may include a scaffold, a reinforcing frame, or reinforcing material (e.g., reinforcing fibers), for example, to impart a stiffness sufficient to maintain integrity before removal, or to facilitate sliding along expandable tip 20 or along catheter 22.

[0035] In some examples, resheath tool 12 comprises a tubular tool body 18 defining tool lumen 16. In some examples, tubular tool body 18 is substantially cylindrical. Resheath tool 12 may include or consist of a single unit, or may include multiple (e.g., separable) portions. In some examples, tool body 18 is unitary, and resheath tool 12 consists of unitary tool body 18 defining tool lumen 16.

[0036] FIG. 2A is a side view of an example assembly 100 in a first configuration including resheath tool 12 of FIG. 1 positioned proximal to an expandable tip 20 of a catheter 22. In the first configuration shown in FIG. 2A, expandable tip 20 is in an expanded configuration. Resheath tool 12 is configured to distally slide over expandable tip 20 of catheter 22 within tool lumen 16 and compress expandable tip 20 that is in the expanded configuration to a compressed configuration. For example, catheter 22 may include an elongate body 24 proximal to expandable tip 20, and resheath tool 12 may be initially positioned over elongate body 24, such that a portion of elongate body 24 is received within tool lumen 16, as shown in FIG. 2A. Then, resheath tool 12 may be slid distally along elongate body 24 toward extendable tip 20.

[0037] FIG. 2B is a side view of assembly 100 of FIG. 2A in a second configuration 100A with resheath tool 12 moved distally along catheter 22 toward expandable tip 20. In second configuration 100A, resheath tool 12 is ready to be moved further distally along catheter 22, to begin compressing expandable tip 20.

[0038] Tool lumen 16 is dimensioned to receive and accommodate a portion of catheter 22 and / or of expandable tip 20 of catheter 22. For example, resheath tool 12 may define an inner tool diameter sufficiently large to at least partially receive expandable tip 20, or may be radially deformable, stretchable, or expandable to an expanded inner diameter that is sufficient to at least partially receive expandable tip 20 (e.g., to initiate compression of expandable tip 20 from the expanded configuration shown in FIGS. 2A and 2B to a compressed configuration).Docket No.: A0012268W001 / 1216-158W001

[0039] Resheath tool 12 may have any suitable length, thickness, or diameter. For example, resheath tool 12 may have a length of at least 1 cm, at least 2 cm, at least 3 cm, or at least 4 cm, or at least 5 cm. In some examples, resheath tool 12 has a length of less than or equal to 10 cm, less than or equal to 9 cm, less than or equal to 8 cm, less than or equal to 7 cm, less than or equal to 6 cm, less than or equal to 5 cm, less than or equal to 4 cm, less than or equal to 3 cm, or less than or equal to 2 cm. In some examples, resheath tool 12 has a length in a range from 1 cm to 10 cm, or from 2 cm to 5 cm, or from 3 cm to 6 cm. In some examples, resheath tool 12 has a length that is at least 10%, at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, or at least 80%, of a working length of catheter 22. In some examples, resheath tool 12 has a length that is 90% or less, 80% or less, 70% or less, 60% or less, 50% or less, 40% or less, 30% or less, 20% or less, or 10% or less, of a working length of catheter 22. In some examples, resheath tool 12 has a length that is at least 20%, at least 50%, at least 60%, at least 80%, at least 100%, at least 110%, at least 120%, or at least 150%, of a length of expandable tip 20 of catheter 22. In some examples, resheath tool 12 has a length that is 200% or less, 150% or less, 120% or less, 110% or less, 100% or less, 80% or less, 60% or less, 20% or less, or 10% or less, of a length of expandable tip 20 of catheter 22. In some examples, resheath tool 12 has a wall thickness of at least 0.001 inches, of at least 0.002, inches, at least 0.003 inches, or at least 0.004 inches. In some examples, resheath tool 12 has a wall thickness of 0.0034 inches. In some examples, resheath tool 12 has an inner tool diameter in a range from 4F to 20F, or any suitable inner tool diameter configured to receive a predetermined diameter of expandable tip 20 or of catheter 22.

[0040] FIG. 2C is a side view of assembly 100 of FIG. 2A in a third configuration 100B with resheath tool 12 receiving expandable tip 20 in a compressed configuration 20 A. For example, compared to expanded configuration 20 shown in FIGS. 2A and 2B, compressed configuration 20A exhibits a reduced outer diameter and an overall compressed shape. In some examples, tool lumen 16 is dimensioned to snugly receive expandable tip 20 (e.g., in compressed configuration 20A). For example, to snugly receive expandable tip 20, the inner tool diameter may substantially correspond to an outer diameter of expandable tip 20 in compressed configuration 20A, or may be smaller than the outer diameter of expandable tip 20 in compressed configuration 20 A to cause snug contact between an inner surface of resheath tool 12 and an outer surface of expandable tip 20 in compressed configuration 20 A. In the snug contact (e.g., to snugly receive expandable tip 20), there may be no gap between an inner surface of resheath tool 12 and an outer surface of expandable tip 20 in compressed configuration 20A. Compressed configuration 20A of expandable tip 20 retained by resheath tool 12 is ready for resheathing. InDocket No.: A0012268W001 / 1216-158W001 some examples, resheath tool 12 is positioned over compressed configuration 20A such that a distal portion 24 of expandable tip 20 extends distally out from and beyond resheath tool 12.

[0041] FIG. 2D is a side view of assembly 100 of FIG. 2 A in a fourth configuration 100C with sheath 14 of FIG. 1 ready to be moved over distal portion 24 of expandable tip 20 in compressed configuration 20A. Sheath 14 is slidable proximally over expandable tip 20 while expandable tip 20 is held in compressed configuration 20A by resheath tool 12 (e.g., at least over distal portion 24 of expandable tip 20 in compressed configuration 20A).

[0042] Turning back to FIG. 1, sheath 14 defines a sheath lumen 26 extending along a longitudinal sheath axis S. In some examples, in addition to receiving at least distal portion 24 of expandable tip 20, sheath lumen 26 is configured to at least partially receive resheath tool 12 while expandable tip 20 of catheter 22 is held in compressed configuration 20A by resheath tool 12.

[0043] Sheath 14 may have any suitable length, thickness, or diameter. For example, sheath 14 may have a length of at least 1 cm, at least 2 cm, at least 3 cm, or at least 4 cm, or at least 5 cm. In some examples, sheath 14 has a length of less than or equal to 10 cm, less than or equal to 9 cm, less than or equal to 8 cm, less than or equal to 7 cm, less than or equal to 6 cm, less than or equal to 5 cm, less than or equal to 4 cm, less than or equal to 3 cm, or less than or equal to 2 cm. In some examples, sheath 14 has a length in a range from 1 cm to 10 cm, or from 2 cm to 5 cm, or from 3 cm to 6 cm. In some examples, sheath 14 has a length that is at least 10%, at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, or at least 80%, of a working length of catheter 22. In some examples, sheath 14 has a length that is 90% or less, 80% or less, 70% or less, 60% or less, 50% or less, 40% or less, 30% or less, 20% or less, or 10% or less, of a working length of catheter 22. In some examples, sheath 14 has a length that is at least 20%, at least 50%, at least 60%, at least 80%, at least 100%, at least 110%, at least 120%, or at least 150%, of a length of expandable tip 20 of catheter 22. In some examples, sheath 14 has a length that is 200% or less, 150% or less, 120% or less, 110% or less, 100% or less, 80% or less, 60% or less, 20% or less, or 10% or less, of a length of expandable tip 20 of catheter 22. In some examples, sheath 14 has a length that is at least 20%, at least 50%, at least 60%, at least 80%, at least 100%, at least 110%, at least 120%, or at least 150%, of a length of resheath tool 12. In some examples, sheath 14 has a length that is 200% or less, 150% or less, 120% or less, 110% or less, 100% or less, 80% or less, 60% or less, 20% or less, or 10% or less, of a length of resheath tool 12. In some examples, sheath 14 has a wall thickness of at least 0.001 inches, of at least 0.002, inches, at least 0.003 inches, or at least 0.004 inches. In some examples, sheath 14 has a wall thickness of 0.003 inches. In some examples, sheath 14 has an inner tool diameter in aDocket No.: A0012268W001 / 1216-158W001 range from 4F to 20F, or any suitable inner tool diameter configured to receive a predetermined diameter of resheath tool 12, of expandable tip 20, or of catheter 22.

[0044] For example, sheath 14 may define an inner sheath diameter sufficiently large to at least partially receive resheath tool 12, or may be radially deformable, stretchable, or expandable to an expanded inner diameter that is sufficient to at least partially receive resheath tool 12. In some examples, at least a portion of resheath tool 12 and / or sheath 14 has a constant inner tool diameter along longitudinal tool axis T. In some examples, at least a portion of resheath tool 12 and / or sheath 14 has a varying tool diameter (e.g., one or both of increasing or decreasing) along longitudinal tool axis T. In some examples, a distal portion of resheath tool 12 has a greater inner diameter than a proximal portion of resheath tool 12, for example, to facilitate initiation of sliding over expandable tip 20 when expandable tip 20 is in an expanded configuration. In some examples, a distal portion of sheath 14 has a greater inner diameter than a proximal portion of sheath 14, for example, to facilitate initiation of sliding of sheath 14 over resheath tool 12 or over expandable tip when expandable tip 20 is in an expanded configuration.

[0045] Sheath 14 may include or is (e.g., consist of) a single unit, or may include multiple (e.g., separable) portions. In some examples, sheath 14 is a unitary sheath body defining sheath lumen 20. In some examples, the unitary sheath body may be peelable to facilitate removal of sheath 14 from catheter 22 (e.g., to allow redeployment of expandable tip 20 back into an expanded configuration from the compressed configuration 20A).

[0046] FIG. 2E is a side view of assembly 100 of FIG. 2A in a fifth configuration 100D with a proximal portion 28 of sheath 14 receiving distal portion 24 of expandable tip 20 in the compressed configuration 20A. In this configuration, expandable tip 20 is retained by both resheath tool 12 and sheath 14 in compressed configuration 20 A, such that sheath 14 can be continued to be moved proximally while retaining expandable tip 20 in compressed configuration 20A. In some examples, sheath 14 is dimensioned to slide proximally over expandable tip 20 in compressed configuration 20 A, and to push resheath tool 12 proximally along expandable tip 20 during the proximal sliding. For example, sheath 14 may be dimensioned to slide at least partially over a distal portion of resheath tool 14 and push resheath tool 14 proximally along expandable tip 20 during the proximal sliding.

[0047] FIG. 2F is a side view of assembly 100 of FIG. 2A in a sixth configuration 100E with sheath 14 and resheath tool 12 moved proximal of expandable tip 20 in compressed configuration 20A, with sheath 14 receiving expandable tip 20 in compressed configuration 20. Thus, in configuration 100E, a sufficient portion of expandable 20 in compressed configuration 20A is received within lumen 26 of sheath 14 to retain expandable 20 in compressed configuration 20 A. Now resheath tool 14 can be removed from catheter 22.Docket No.: A0012268W001 / 1216-158W001

[0048] FIG. 2G is a side view of assembly 100 of FIG. 2 A in a seventh configuration 100F with resheath tool 12 removed from catheter 22, to leave expanded tip 20 in compressed configuration 20A and received in sheath 14. In some examples, resheath tool 12 is removable from expandable tip 20 in compressed configuration 20A after expandable tip 20 is compressed by sheath 14. For example, in seventh configuration 100F, resheath tool 12 may be split into a separated configuration 12 A, as shown in FIG. 2G.

[0049] In some examples, resheath tool 12 is at least partially peelable along longitudinal tool axis T to facilitate removal of resheath tool 12 from expandable tip 20 of catheter 22. For example, resheath tool 12 may define at least one peel line 30, as illustrated in FIG. 2F, extending in a direction along longitudinal tool axis T. Thus, resheath tool 12 may be peeled along peel line 30 into separated configuration 12 A, illustrated in FIG. 2G, to facilitate removal of resheath tool 12. In some examples, resheath tool 12 further defines a tab to facilitate peeling along peel line 30. Peel line 30 may include a scored portion, or a portion having a relatively lower thickness than a remaining portion of resheath tool 12. In some examples, peel line 30 defines a plurality of perforations. In some examples, a releasable adhesive is applied along peel line 30, such that pulling along peel line 30 releases the releasable adhesive to allow peeling.

[0050] After resheath tool 12 is removed, catheter 22 with expandable tip 20 retained in compressed configuration 20A by sheath 14 is ready to be reused, for example, by being reintroduced into anatomy. In some examples, sheath 14 is peelable from expandable tip 20 in the compressed configuration 20A to allow expandable tip 20 to expand from compressed configuration 20A back to the expanded configuration when resheath tool 12 is partially or fully removed from the expandable tip (20, as shown in FIG. 2A).

[0051] Turning back to FIG. 2A, catheter 22 may include an elongate body 32. A distal portion of elongate body 32 may include expandable tip 20. Expandable tip 20 may include any suitable expandable element, for example, a funnel, a basket, a stent-like structure, or a balloon. In some examples, expandable tip 20 of catheter 22 includes a funnel defining a distal opening 34. For example, the funnel may be conical, or have an increasing diameter in a distal direction. In some examples, expandable tip 20 defines a mesh or is porous. Expandable tip 20 is configured to capture, retrieve, or retract material or a device (e.g., a thrombus, a thrombectomy device, a tool, unwanted material or debris, a collection basket, a collection bag, a collection mesh, or an inflatable device or a balloon, an expandable nitinol element such as a disk, bulb, and / or bundle, a polymeric plug, and / or arcuate, e.g., circular disk) from anatomy of a patient.

[0052] Expandable tip 20 is configured to expand from compressed configuration 20A within a lumen, for example, a body lumen. Catheter 22 can be utilized with clot capture systems, or for material retrieval, or in any method that requires the retraction of material through catheter 22.Docket No.: A0012268W001 / 1216-158W001For example, catheter 22 may be utilized for tubular body retrieval, catheter retrieval, in any method that requires the retraction of tools, or in any surgical procedure or method.

[0053] In this way, assembly 100 can be used to resheath expandable tip 20 to a compressed configuration 20, for one or more sessions of reuse and redeployment.

[0054] In some examples, a kit may include one or more components of assembly 100. For example, a kit may include a housing, the housing including resheath tool 12 and sheath 14. In some examples, the housing further includes catheter 22 including expandable tip 20. In some examples, catheter 22 is configured to capture material from a vascular system. For example, the material may include an embolus, a thrombus, or a clot-capture device.

[0055] The housing may be any suitable housing, including a flexible or rigid material and configured to retain resheath tool 12 and sheath 14 in a sterile environment. In some examples, the housing includes a pouch, a bag, an envelope, a box, a backing card, or a vacuum formed package.

[0056] FIG. 3A is a side view of an example sheath 214 including a skived sheath portion 217. FIG. 3B is a front view of sheath 214 of FIG. 3A. Sheath 214 may be similar to sheath 14 described with reference to FIGS. 1 and 2A to 2G, but differ in the presence of a skive. For example, sheath 214 defines skived sheath portion 217 extending from a tubular sheath portion 219. Skived sheath portion 217 may have any suitable length, for example, less than, equal to, or greater than a length of tubular sheath portion 219. Skived sheath portion 217 may facilitate gripping, holding, or pulling of sheath 214 to remove sheath 214 from an expandable tip retained in a compressed configuration to allow the expandable tip to expand from the compressed configuration to an expanded configuration.

[0057] FIG. 4 is a side view of an example peelable resheath tool 212 including a peel line 221 and a slit 223. Resheath tool 212 may be similar to resheath tool 12 described with reference to FIGS. 1 and 2 A to 2G, but differ in the presence of a slit. Slit 223 may have any suitable length, for example, less than, equal to, or greater than a length of peel line 221. Slit 223 may facilitate separation of portions of resheath tool 212 to induce peeling along peel line 221. In some examples, peel line 221 and slit 223 in combination extend along an entire length of resheath tool 212. In other examples, peel line 221 and slit 223 in combination may extend to less than an entire length of resheath tool 212. Peel line 221 may include scored or perforated features along its length to facilitate peeling of resheath tool 212 along peel line 221. In some examples, resheath tool 212 includes a plurality of peel lines 221 and / or a plurality of slits 221. In some examples, resheath tool 212 does not include any pre-defined peel line 221, but may only include one or more slit 221 to facilitate separation and tearing of material along a length of resheath tool 212.Docket No.: A0012268W001 / 1216-158W001

[0058] FIG. 5A is a side view of an example resheath tool 312 including a first tool portion 312A and a second tool portion 312B removably securable to first tool portion 312A in an unassembled configuration. FIG. 5B is a front view of resheath tool 312 of FIG. 5A in the unassembled configuration. At least one of first tool portion 312A or second tool portion 312B defines a first fastening element 325A, and at least another of first tool portion 312A or second tool portion 312B defines a second fastening element 325B configured to removably couple with first fastening element 325 A to removably secure first tool portion 312A and second tool portion 312B.

[0059] In some examples, first fastening element 325A and 325B are complementary. For example, first fastening element 325A may include a protrusion, and second fastening element 325B may define a recess complementary to the protrusion. In some examples, first fastening element 325A includes an alignment pin, clamp, or clip, and second fastening element 325B may define an opening configured to receive the alignment pin, clamp, or clip. In some examples, resheath tool 312 may include a plurality of first fastening elements 325A and second fastening elements 325, and may include identical or different fastening elements. In some examples, first fastening element 325A and second fastening element 325B continuously or integrally extend from or are defined respectively by first tool portion 312A or second tool portion 312B. In other examples, first fastening element 325A and second fastening element 325B are respectively discrete from and secured to first tool portion 312A or second tool portion 312B.

[0060] FIG. 6A is a side view of the resheath tool of FIG. 5 A in an assembled configuration. FIG. 6B is a front view of the resheath tool of FIG. 6A in the assembled configuration. First tool portion 312A and second tool portion 312B may define a tool lumen 316 therebetween and extending along longitudinal tool axis T.

[0061] In some examples, first tool portion 312A defines a first tool wall 327A, and second tool portion 312B defines a second tool wall 327B. Second tool wall 327B may be configured to face first tool wall 327A when first tool portion 312A and second tool portion 312B are secured to each other. First fastening element 325A (e.g., a protrusion or a pin) may extend from first tool wall 327A, and second tool wall 327B may define second fastening element 325B (e.g., a recess or an opening, or some other structure complementary to first fastening element 325A).

[0062] Resheath tool 312 may define different diameters along a length of resheath tool 312. For example, a proximal portion of resheath tool 312 may have a relatively larger diameter than a distal portion of resheath tool 312. In some examples, a relatively smaller diameter of the distal portion of resheath tool 312 may facilitate sliding of a sheath over the distal portion of resheath tool 312, while the relatively larger diameter of the proximal portion of resheath tool 312 may prevent the sheath from inadvertently sliding over an entirety of resheath tool 312.Docket No.: A0012268W001 / 1216-158W001

[0063] FIG. 7A is a side view of an example sheath 414 including a flared portion 417. FIG. 7B is a front view of sheath 414 of FIG. 7A. Sheath 414 may be similar to sheath 14 described with reference to FIGS. 1 and 2A to 2G, or sheath 214 described with reference to FIGS. 3A and 3B, but differ in the presence of a flared sheath portion. For example, sheath 214 may define flared sheath portion 417 extending from a tubular sheath portion 419. Flared sheath portion 217 may have any suitable length, for example, less than, equal to, or greater than a length of tubular sheath portion 419. Flared sheath portion 417 may facilitate sliding of sheath 414 over a portion of a resheath tool or a catheter. For example, flared sheath portion 417 may receive an end portion of the resheath tool or the catheter and promote entry of the end portion of the resheath tool or the catheter within a remaining portion of sheath 414 (e.g., within tubular sheath portion 419).

[0064] In some examples, flared sheath portion 417 extends from tubular sheath portion 419 to an end of sheath 414. In some examples, sheath 414 includes two flared sheath portions, for example, respectively extending to each end of sheath 414. In some examples, flared sheath portion 417 is skived, similar to skived sheath portion 217 described with reference to FIGS. 3A and 3B.

[0065] FIG. 8 is a side view of an example resheath tool 512 including a flared tool portion 517. Resheath tool 512 may be similar to resheath tool 12 described with reference to FIGS. 1 and 2A to 2G, but differ in the presence of a flared tool portion. For example, resheath tool 512 may define flared portion 517 extending from a tubular tool portion 519. Flared tool portion 517 may have any suitable length, for example, less than, equal to, or greater than a length of tubular tool portion 519. Flared tool portion 517 may facilitate sliding of tool 512 over a portion of a catheter. For example, flared tool portion 512 may receive an end portion of the catheter and promote entry of the end portion of the catheter within a remaining portion of resheath tool 512 (e.g., within tubular tool portion 519).

[0066] In some examples, flared tool portion 517 extends from tubular tool portion 519 to an end of resheath tool 512. In some examples, resheath tool 512 includes two flared sheath portions, for example, respectively extending to each end of resheath tool 512.

[0067] In some examples, resheath tool 512 is configured to receive and compress an expandable tip of a catheter (e.g., expandable tip 20), without requiring a sheath. Thus, in some examples, resheath tool 512 may perform functions described herein with reference to either of a sheath or a resheath tool. For example, an expandable tip of a catheter may be temporarily compressed by a clinician (e.g., pinched or pressed by a finger or a tool), introduced into flared tool portion 517, moved within resheath tool 512, followed by release of the compression to allow the expandable tip to be retained within resheath tool 512. The expandable tip of theDocket No.: A0012268W001 / 1216-158W001 catheter may be introduced proximally or distally into and through resheath tool 512, depending on the location of flared tool portion 517 (e.g., at a distal end or a proximal end of resheath tool 512).

[0068] In some examples, resheath tool 517 may further include one or both of a peel line 521 and a slit 523, which may be similar to peel line 221 and slit 223 described with reference to FIG. 4.

[0069] FIG. 9 is an example technique for resheathing an expandable tip of a catheter using an assembly including a resheath tool and a sheath. The technique is described with reference to assembly 10 of FIG. 1 as an example. However, the technique of FIG. 9 may be implemented using any example assembly, resheath tool, or sheath according to the present disclosure.Further, in some examples, only a resheath tool may be used without a sheath to compress an expandable tip of a catheter for resheathing the expandable tip of the catheter.

[0070] In some examples, the example technique includes sliding resheath tool 12 distally over expandable tip 20 of catheter 22 to compress expandable tip 20 from an expanded configuration to compressed configuration 20A (602). The example technique may further include sliding sheath 14 proximally over expandable tip 20 while expandable tip 20 is held in compressed configuration 20A by resheath tool 12 (604).

[0071] The technique may further include removing resheath tool 10 from the catheter to leave the expandable tip in the compressed configuration received in at least a portion of sheath 12 (606). The technique may further include introducing catheter 22 in a vessel of the patient with expandable tip 20 in compressed configuration 20A received in at least a portion of sheath 14 (608). In some examples, the technique further includes removing sheath 14 from catheter 22 to allow expandable tip 20 to expand from compressed configuration 20A to expanded configuration 20 (610). The technique may be repeated one or more times, for example, to repeat a procedure.

[0072] Components of assemblies and articles according to the present disclosure may be formed using any suitable technique. For example, one or both of a resheath tool or a sheath may be formed by extrusion, coextrusion, molding, casting, stamping, cutting, additive manufacturing, or subtractive manufacturing.

[0073] The following enumerated clauses describe examples according to the present disclosure.

[0074] Clause 1 : An assembly for resheathing an expandable tip of a catheter, the assembly including: a resheath tool defining a tool lumen extending along a longitudinal tool axis, the resheath tool being configured to distally slide over the expandable tip of the catheter within the tool lumen and compress the expandable tip that is in an expanded configuration to a compressedDocket No.: A0012268W001 / 1216-158W001 configuration; and a sheath slidable proximally over the expandable tip while the expandable tip is held in the compressed configuration by the resheath tool.

[0075] Clause 2: The assembly of clause 1, where the resheath tool includes a tubular tool body defining the tool lumen.

[0076] Clause 3: The assembly of clauses 1 or 2, where the resheath tool is a unitary tool body defining the tool lumen.

[0077] Clause 4: The assembly of any of clauses 1 to 3, where the sheath defines a sheath lumen extending along a longitudinal sheath axis, the sheath lumen configured to at least partially receive the resheath tool while the expandable tip is held in the compressed configuration by the resheath tool.

[0078] Clause 5: The assembly of clause 4, where the sheath is a unitary sheath body defining the sheath lumen.

[0079] Clause 6: The assembly of any of clauses 1 to 5, where the tool lumen is dimensioned to snugly receive the expandable tip.

[0080] Clause 7: The assembly of any of clauses 1 to 6, where the resheath tool is at least partially peelable along the longitudinal tool axis to facilitate removal of the resheath tool from the expandable tip of the catheter.

[0081] Clause 8: The assembly of clause 7, where the resheath tool defines at least one peel line extending in a direction along the longitudinal tool axis.

[0082] Clause 9: The assembly of any of clauses 1 to 8, where the resheath tool is removable from the expandable tip after the expandable tip is compressed by the sheath.

[0083] Clause 10: The assembly of any of clauses 1 to 9, where the sheath is peelable from the expandable tip to allow the expandable tip to expand from the compressed configuration to the expanded configuration when the resheath tool is partially or fully removed from the expandable tip.

[0084] Clause 11 : The assembly of any of clauses 1 to 10, where the sheath is dimensioned to slide proximally over the expandable tip in the compressed configuration, and to push the resheath tool proximally along the expandable tip during the proximal sliding.

[0085] Clause 12: The assembly of clause 11, where the sheath is dimensioned to slide at least partially over a distal portion of the resheath tool and push the resheath tool proximally along the expandable tip during the proximal sliding.

[0086] Clause 13: The assembly of any of clauses 1 to 12, where the sheath defines a skived sheath portion extending from a tubular sheath portion.Docket No.: A0012268W001 / 1216-158W001

[0087] Clause 14: The assembly of any of clauses 1 to 13, where the resheath tool includes a first tool portion and a second tool portion at least partially separable from the first tool portion, and where the first tool portion and the second tool portion define the tool lumen therebetween.

[0088] Clause 15: The assembly of clause 14, where the resheath tool defines at least one slit between the first tool portion and the second tool portion, and where the at least one slit extends in a direction along the longitudinal axis of the resheath tool.

[0089] Clause 16: The assembly of clauses 14 or 15, where the first tool portion and the second tool portion are removably securable to each other.

[0090] Clause 17: The assembly of clause 16, where at least one of the first tool portion or the second tool portion defines a first fastening element, and where at least another of the first tool portion or the second tool portion defines a second fastening element configured to removably couple with the first fastening element to removably secure the first tool portion and the second tool portion.

[0091] Clause 18: The assembly of clause 17, where the first fastening element includes a protrusion, and where the second fastening element includes a recess complementary to the protrusion.

[0092] Clause 19: The assembly of clause 18, where the first tool portion defines a first tool wall, where the second tool portion defines a second tool wall, the second tool wall being configured to face the first tool wall when the first tool portion and the second tool portion are secured to each other, where the protrusion extends from the first tool wall, and where the second tool wall defines the recess.

[0093] Clause 20: The assembly of any of clauses 1 to 19, where one or both of the resheath tool or the sheath includes a polymer.

[0094] Clause 21 : The assembly of clause 20, where the polymer includes polytetrafluoroethylene.

[0095] Clause 22: The assembly of any of clauses 1 to 21, where the resheath tool defines at least one flared tool portion.

[0096] Clause 23 : The assembly of any of clauses 1 to 22, where the sheath defines at least one flared sheath portion.

[0097] Clause 24: The assembly of any of clauses 1 to 23, further including the catheter.

[0098] Clause 25: The assembly of clause 24, where the catheter includes an elongate body, a distal portion of the elongate body including the expandable tip, and where the expandable tip of the catheter includes a funnel defining a distal opening of the catheter.Docket No.: A0012268W001 / 1216-158W001

[0099] Clause 26: A resheath tool including: a first tool portion; and a second tool portion removably securable to the first tool portion, where the first tool portion and the second tool portion define a tool lumen therebetween and extending along a longitudinal tool axis.

[0100] Clause 27: The resheath tool of clause 26, where at least one of the first tool portion or the second tool portion defines a first fastening element, and where at least another of the first tool portion or the second tool portion defines a second fastening element configured to removably couple with the first fastening element to removably secure the first tool portion and the second tool portion.

[0101] Clause 28: The resheath tool of clause 27, where the first fastening element includes a protrusion, and where the second fastening element includes a recess complementary to the protrusion.

[0102] Clause 29: The resheath tool of clause 28, where the first tool portion defines a first tool wall, where the second tool portion defines a second tool wall, the second tool wall being configured to face the first tool wall when the first tool portion and the second tool portion are secured to each other, where the protrusion extends from the first tool wall, and where the second tool wall defines the recess.

[0103] Clause 30: A method including forming a resheath tool according to any of clauses 1 to 29.

[0104] Clause 31 : A method including forming a sheath according to any of clauses 1 to 25.

[0105] Clause 32: A method including: sliding a resheath tool according to any of clauses 1 to 29 distally over an expandable tip of a catheter to compress the expandable tip from an expanded configuration to a compressed configuration; and sliding a sheath according to any of clauses 1 to 25 proximally over the expandable tip while the expandable tip is held in the compressed configuration by the resheath tool.

[0106] Clause 33: The method of clause 32, further including removing the resheath tool from the catheter to leave the expandable tip in the compressed configuration received in at least a portion of the sheath.

[0107] Clause 34: The method of clause 33, further including introducing the catheter in a vessel of the patient, the catheter including the expandable tip in the compressed configuration received in at least a portion of the sheath.

[0108] Clause 35: The method of clause 34, further including removing the sheath from the catheter to allow the expandable tip to expand from the compressed configuration to an expanded configuration.

[0109] Clause 36: A kit including a housing, the housing including a resheath tool according to any of clauses 1 to 29 and a sheath according to any of clauses 1 to 25.Docket No.: A0012268W001 / 1216-158W001

[0110] Clause 37: The kit of clause 36, where the housing further includes a catheter including an expandable tip, and where the catheter is configured to capture material from a vascular system.[oni] Clause 38: The kit of clause 37, where the material includes an embolus, a thrombus, or a clot-capture device.

[0112] Various examples have been described. These and other examples are within the scope of the following claims.

Claims

Docket No.: A0012268W001 / 1216-158W001CLAIMSWhat is claimed is:

1. An assembly for resheathing an expandable tip of a catheter, the assembly comprising: a resheath tool defining a tool lumen extending along a longitudinal tool axis, the resheath tool being configured to distally slide over the expandable tip of the catheter within the tool lumen and compress the expandable tip that is in an expanded configuration to a compressed configuration; and a sheath slidable proximally over the expandable tip while the expandable tip is held in the compressed configuration by the resheath tool.

2. The assembly of claim 1, wherein the resheath tool comprises a tubular tool body defining the tool lumen.

3. The assembly of any one of claims 1 or 2, wherein the resheath tool is a unitary tool body defining the tool lumen.

4. The assembly of any one of claims 1 to 3, wherein the sheath defines a sheath lumen extending along a longitudinal sheath axis, the sheath lumen configured to at least partially receive the resheath tool while the expandable tip is held in the compressed configuration by the resheath tool.

5. The assembly of claim 4, wherein the sheath is a unitary sheath body defining the sheath lumen.

6. The assembly of any one of claims 1 to 5, wherein the resheath tool is at least partially peelable along the longitudinal tool axis to facilitate removal of the resheath tool from the expandable tip of the catheter, and wherein the resheath tool defines at least one peel line extending in a direction along the longitudinal tool axis.

7. The assembly of any one of claims 1 to 6, wherein the sheath is peelable from the expandable tip to allow the expandable tip to expand from the compressed configuration to theDocket No.: A0012268W001 / 1216-158W001 expanded configuration when the resheath tool is partially or fully removed from the expandable tip.

8. The assembly of any one of claims 1 to 7, wherein the sheath defines a skived sheath portion extending from a tubular sheath portion.

9. The assembly of any one of claims 1 to 8, wherein the resheath tool comprises a first tool portion and a second tool portion at least partially separable from the first tool portion, wherein the first tool portion and the second tool portion define the tool lumen therebetween, and wherein the resheath tool defines at least one slit between the first tool portion and the second tool portion, and wherein the at least one slit extends in a direction along the longitudinal axis of the resheath tool.

10. The assembly of claim 9, wherein the first tool portion and the second tool portion are removably securable to each other, wherein at least one of the first tool portion or the second tool portion defines a first fastening element, and wherein at least another of the first tool portion or the second tool portion defines a second fastening element configured to removably couple with the first fastening element to removably secure the first tool portion and the second tool portion.

11. The assembly of claims 1 to 10, wherein one or both of the resheath tool or the sheath comprises a polymer.

12. The assembly of claims 1 to 11, wherein the resheath tool defines at least one flared tool portion, or wherein the sheath defines at least one flared sheath portion.

13. A resheath tool comprising: a first tool portion; and a second tool portion removably securable to the first tool portion, wherein the first tool portion and the second tool portion define a tool lumen therebetween and extending along a longitudinal tool axis.Docket No.: A0012268W001 / 1216-158W00114. The resheath tool of claim 13, wherein at least one of the first tool portion or the second tool portion defines a first fastening element, wherein at least another of the first tool portion or the second tool portion defines a second fastening element configured to removably couple with the first fastening element to removably secure the first tool portion and the second tool portion, wherein the first fastening element comprises a protrusion, and wherein the second fastening element comprises a recess complementary to the protrusion.

15. The resheath tool of claim 14, wherein the first tool portion defines a first tool wall, wherein the second tool portion defines a second tool wall, the second tool wall being configured to face the first tool wall when the first tool portion and the second tool portion are secured to each other, wherein the protrusion extends from the first tool wall, and wherein the second tool wall defines the recess.

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