US-20260123944-A1 - DEVICES FOR CROSSING OCCLUSIONS

US20260123944A1US 20260123944 A1US20260123944 A1US 20260123944A1US-20260123944-A1

Abstract

Ablation, crossing, and cutting systems, devices and associated methods can relate to a crossing device that includes, in combination a spring-enhanced handle and body configured to controllably extend and retract an interventional tool within a microcatheter for addressing an occlusion within a vessel of a patient to provide improved access for supplemental treatment and reperfusion.

Inventors

Thanh Nguyen
Outhit Bouasaysy

Assignees

REFLOW MEDICAL, INC.

Dates

Publication Date: 20260507
Application Date: 20251027

Claims (20)

1 . A crossing device comprising: a catheter having a distal handle defining an engager; a proximal handle defining a channel having a longitudinal portion and a circumferential portion, wherein the proximal handle is configured to translate along a longitudinal axis with the engager within the longitudinal portion, wherein the proximal handle is further configured to rotate about the longitudinal axis with the engager within the circumferential portion; an interventional tool extending within the catheter and the proximal handle; and a plunger coupled to a proximal end of the interventional tool, wherein the plunger is configured to move between the proximal handle and the distal handle.
2 . The crossing device of claim 1 , further comprising a spring biasing the plunger and the distal handle away from each other.
3 . The crossing device of claim 1 , wherein: the plunger includes a first magnet; the distal handle includes a second magnet the first magnet and the second magnet are configured to bias the plunger and the distal handle away from each other.
4 . The crossing device of claim 1 , wherein the circumferential portion of the channel is proximal to the longitudinal portion of the channel.
5 . The crossing device of claim 1 , wherein: in a retracted configuration of the plunger and a retracted configuration of the proximal handle with the engager within the longitudinal portion of the channel, a distal end of the interventional tool is proximal to a distal end of the catheter; in the retracted configuration of the plunger and a locked configuration of the proximal handle with the engager within the circumferential portion of the channel, the distal end of the interventional tool is distal to the distal end of the catheter; and in an extended configuration of the plunger and the locked configuration of the proximal handle with the engager within the circumferential portion of the channel, the distal end of the interventional tool is distal to the distal end of the catheter.
6 . The crossing device of claim 1 , wherein: in a retracted configuration of the plunger and a retracted configuration of the proximal handle with the engager within the longitudinal portion of the channel, a distal end of the interventional tool is proximal to a distal end of the catheter; in the retracted configuration of the plunger and a locked configuration of the proximal handle with the engager within the circumferential portion of the channel, the distal end of the interventional tool is proximal to the distal end of the catheter; and in an extended configuration of the plunger and the locked configuration of the proximal handle with the engager within the circumferential portion of the channel, the distal end of the interventional tool is distal to the distal end of the catheter.
7 . The crossing device of claim 1 , wherein: the engager is a first engager; the channel is a first channel; the distal handle further defines a second engager; and the proximal handle further defines a second channel for receiving the second engager.
8 . The crossing device of claim 1 , wherein: the longitudinal portion is a first longitudinal portion; the circumferential portion is a first circumferential portion; the channel has a second longitudinal portion and a second circumferential portion; and the proximal handle is further configured to translate along the longitudinal axis with the engager within the second longitudinal portion, wherein the proximal handle is further configured to rotate about the longitudinal axis with the engager within the second circumferential portion.
9 . The crossing device of claim 8 , wherein: the first longitudinal portion of the channel is distal to the first circumferential portion of the channel; the first circumferential portion of the channel is distal to the second longitudinal portion of the channel; and the second longitudinal portion of the channel is distal to the second circumferential portion of the channel.
10 . The crossing device of claim 8 , wherein: in a retracted configuration of the plunger and a retracted configuration of the proximal handle with the engager within the first longitudinal portion of the channel, a distal end of the interventional tool is proximal to a distal end of the catheter; in the retracted configuration of the plunger and a first locked configuration of the proximal handle with the engager within the first circumferential portion of the channel, the distal end of the interventional tool is proximal to the distal end of the catheter; and in the retracted configuration of the plunger and a second locked configuration of the proximal handle with the engager within the second circumferential portion of the channel, the distal end of the interventional tool is distal to the distal end of the catheter.
11 . A crossing device comprising: a catheter having a distal handle; a proximal handle, wherein the proximal handle is configured to translate along a longitudinal axis from a retracted configuration of the proximal handle and rotate about the longitudinal axis to a locked configuration of the proximal handle with respect to the distal handle; an interventional tool extending within the catheter and the proximal handle; and a plunger coupled to a proximal end of the interventional tool, wherein: the plunger is configured to move within a first range of motion between the proximal handle and the distal handle while the proximal handle is in the retracted configuration; and the plunger is configured to move within a second range of motion, different from the first range of motion, between the proximal handle and the distal handle while the proximal handle is in the locked configuration.
12 . The crossing device of claim 11 , wherein: in a retracted configuration of the plunger and the retracted configuration of the proximal handle, a distal end of the interventional tool is proximal to a distal end of the catheter; in the retracted configuration of the plunger and the locked configuration of the proximal handle, the distal end of the interventional tool is distal to the distal end of the catheter; and in an extended configuration of the plunger and the locked configuration of the proximal handle, the distal end of the interventional tool is distal to the distal end of the catheter.
13 . The crossing device of claim 11 , wherein the second range of motion is smaller than the first range of motion.
14 . A method comprising: providing a crossing device with an interventional tool within a catheter while an engager of a distal handle of the catheter is within a longitudinal portion of a channel of a proximal handle such that a plunger coupled to the interventional tool has a first range of motion with respect to the catheter; advancing the proximal handle distally with respect to the distal handle by advancing the engager within the longitudinal portion of the channel such that the plunger has a second range of motion, different from the first range of motion, with respect to the catheter; and rotating the proximal handle with respect to the distal handle by moving the engager out of the longitudinal portion and circumferentially within a circumferential portion of the channel such that the proximal handle is in a locked configuration with respect to the distal handle in which longitudinal retraction of the proximal handle is limited.
15 . The method of claim 14 , further comprising, while the engager is within the circumferential portion of the channel, advancing the plunger and the interventional tool distally with respect to the proximal handle and the catheter.
16 . The method of claim 14 , wherein the second range of motion is smaller than the first range of motion.
17 . The method of claim 14 , further comprising rotating the proximal handle with respect to the distal handle by moving the engager circumferentially within the circumferential portion of the channel such that the proximal handle is in an unlocked configuration with respect to the distal handle.
18 . The method of claim 17 , further comprising retracting the proximal handle proximally with respect to the distal handle by retracting the engager within the longitudinal portion of the channel such that the plunger has the first range of motion.
19 . The method of claim 14 , wherein advancing the proximal handle distally with respect to the distal handle includes moving the proximal handle against a biasing force from a spring between the proximal handling and the distal handle.
20 . The method of claim 14 , wherein advancing the proximal handle distally with respect to the distal handle includes moving the proximal handle against a biasing force from two or more magnets positioned at the proximal handling and the distal handle.

Description

CROSS-REFERENCE TO RELATED APPLICATION This application claims the benefit of U.S. Provisional Application No. 63/714435, entitled “DEVICES FOR CROSSING OCCLUSIONS,” filed October 31, 2024, the entirety of which is incorporated herein by reference. TECHNICAL FIELD The present description relates in general to medical devices, and more particularly to, for example, without limitation, devices for crossing occlusions. BACKGROUND Chronic total occlusions (“CTO”) are vascular lesions characterized by heavy atherosclerotic plaque within the blood vessel, resulting in complete (or nearly complete) obstruction of blood flow across the lesion. Such occlusions can occur anywhere in a patient's vascular system. Since most lesions form gradually over a long period of time, the ischemic tissue downstream of the lesion has time to form collateral circulation. For example, in the case of coronary arteries, collateral vessels can form from the proximal artery and connect into the distal artery (“ipsilateral collaterals”), or collateral vessels can form from the other major arterial branches and connect into the distal artery (“contralateral collaterals”). When the lesion finally becomes a total occlusion, the collateral circulation is typically sufficient to keep the distal tissue alive, though ischemic. Accordingly, it is desirable to reestablish blood flow through or around the blockage in blood vessels by crossing the CTO and advancing therapeutic devices, such as a balloon angioplasty catheter, to dilate and treat the CTO. Likewise, in some cases it may be necessary to cross a CTO to gain access to a location along the vasculature distal to the CTO. CTOs can be more difficult to cross than partially occluded lesions because, rather than navigate a pre-existing lumen, a guidewire must either penetrate the lesion or, when penetrating the occlusion is impractically difficult and/or complicated, go around the lesion via a sub-intimal layer of a vessel wall. The description provided in the background section should not be assumed to be prior art merely because it is mentioned in or associated with the background section. The background section may include information that describes one or more aspects of the subject technology. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates a perspective view of a crossing device in a retracted configuration, in accordance with one or more embodiments of the present disclosure. FIG. 2 illustrates a perspective view of a crossing device in an extended configuration, in accordance with one or more embodiments of the present disclosure. FIG. 3 illustrates a side view of a crossing device in a retracted configuration, in accordance with one or more embodiments of the present disclosure. FIG. 4 illustrates a side view of a crossing device in an extended configuration, in accordance with one or more embodiments of the present disclosure. FIG. 5 illustrates an exploded view of a crossing device, in accordance with one or more embodiments of the present disclosure. FIG. 6 illustrates a cross-sectional view of a portion of a crossing device, in accordance with one or more embodiments of the present disclosure. FIG. 7 illustrates a perspective view of an interventional tool of a crossing device, in accordance with one or more embodiments of the present disclosure. FIG. 8 illustrates an exploded view of a crossing device, in accordance with one or more embodiments of the present disclosure. FIG. 9 illustrates a sectional view of a portion of a crossing device in a retracted configuration, in accordance with one or more embodiments of the present disclosure. FIG. 10 illustrates a sectional view of a portion of a crossing device in a retracted configuration, in accordance with one or more embodiments of the present disclosure. FIG. 11 illustrates a partial sectional and exploded view of a portion of a crossing device, in accordance with one or more embodiments of the present disclosure. FIG. 12 illustrates a side view of a crossing device in a retracted configuration, in accordance with one or more embodiments of the present disclosure. FIG. 13 illustrates a side view of the crossing device of FIG. 12 in an extended configuration, in accordance with one or more embodiments of the present disclosure. FIG. 14 illustrates a side view of the crossing device of FIGS. 12 and 13 in a locked configuration, in accordance with one or more embodiments of the present disclosure. FIG. 15 illustrates an exploded perspective view of a portion of a crossing device, in accordance with one or more embodiments of the present disclosure. FIG. 16 illustrates a side view of a crossing device in a retracted (e.g., proximal) configuration, in accordance with one or more embodiments of the present disclosure. FIG. 17 illustrates a side view of the crossing device of FIG. 16 in a first (e.g., intermediate) locked configuration, in accordance with one or more embodiments of the present disclosure. FIG. 18 illustrates a sid