Streamlined treatment of clot removal, angioplasty and prevention of restenosis using a single integrated intravascular device

Patent metadata

Field	Value
Publication number	US-11266426-B2
Application number	US-201916508121-A
Country	US
Kind code	B2
Filing date	Jul 10, 2019
Priority date	Jul 10, 2019
Publication date	Mar 8, 2022
Grant date	Mar 8, 2022

Abstract

A single integrated intravascular device including a stentriever and semi-compliant balloon housed therein. After traversing a clot, the device is deployed to a self-expanded state engaging the clot therein, whereupon the device along with the embedded clot is removed. Detecting through imaging a stenosis at an original position of the captured clot, the device is reintroduced to that location and the stentriever is deployed to a self-expanded state. Inflating the semi-compliant balloon enlarges the stentriever to a hyper-expanded state greater than the self-expanded state thereby dilating the vessel while simultaneously completely detaching/releasing the stentriever from a remaining portion of the device. Then the semi-compliant balloon is collapsed and withdrawn along with the remaining portion of the device, while the detachable/releasable portion of the stentriever in the self-expanded state remains in the vessel.

First claim

What is claimed is:

1. A single integrated intravascular device, comprising:
a pusher member having a proximal end, an opposite distal end;
a self-expanding stentriever comprising an open scaffolding formed by multiple struts secured together; the self-expanding stentriever being transitionable upon withdraw of an externally applied mechanical force between a compressed state having a reduced diameter and a self-expanded state having an enlarged diameter; proximal and distal ends of the self-expanding stentriever being secured to the pusher member at respective proximal and distal securement points; the self-expanding stentriever being detachable or releasable from the pusher member at the respective proximal and distal securement points;
a semi-compliant balloon housed within the self-expanding stentriever and secured to the pusher member extending axially through the semi-compliant balloon; and
an inflation lumen defined axially in the pusher member in fluid communication with the semi-compliant balloon;
wherein the proximal and distal ends of the self-expanding stentriever are releasably securable to the pusher member via respective proximal and distal sleeves;
wherein the proximal and distal ends of the self-expanding stentriever are releasable from the respective proximal and distal sleeves only when the semi-compliant balloon is inflated and the self-expanding stentriever is in a hyper-expanded state having a larger diameter than while in the self-expanded state.

2. A method for using a single integrated intravascular device including: a pusher member having a proximal end, an opposite distal end; a self-expanding stentriever comprising an open scaffolding formed by multiple struts secured together; the self-expanding stentriever transitionable upon withdraw of an external mechanical force between a compressed state having a reduced diameter and a self-expanded state having an enlarged diameter; proximal and distal ends of the self-expanding stentriever being secured to the pusher member at respective proximal and distal securement points; the self-expanding stentriever being detachable or releasable at the respective proximal and distal securement points; a semi-compliant balloon housed within the self-expanding stentriever and secured to the pusher member extending axially through the semi-compliant balloon;
and an inflation lumen defined axially in the pusher member in fluid communication with the semi-compliant balloon; the method comprising the steps of:
advancing a guidewire and microcatheter into a vessel across a target clot;
proximally withdrawing the guidewire while maintaining in position the microcatheter in the vessel traversing the target clot;
while the self-expanding stentriever is in the compressed state with the semi-compliant balloon in a deflated state housed therein, loading the single integrated intravascular device into the lumen of the microcatheter;
advancing the single integrated intravascular device through the lumen of the microcatheter using the pusher member so that the self-expanding stentriever coincides with the target clot;
proximally withdrawing from the vessel the microcatheter, while the single integrated intravascular device is maintained within the vessel crossing the target clot; the self-expanding stentriever when unsheathed from the microcatheter automatically transitioning to the self-expanded state engaging the target clot in the open scaffolding of the self-expanding stentriever, while the semi-compliant balloon housed within the self-expanding stentriever is maintained in a deflated state so as not to interfere with engagement and subsequent embedding of the target clot in the self-expanding stentriever.

3. The method according to claim 2 , further comprising the steps of:
proximally withdrawing from the vessel as a single unit receivable in a proximal catheter the target clot embedded in the self-expanding stentriever while in the self-expanded state together with the semi-compliant balloon while in the deflated state housed therein;
detecting through imaging the presence of an underlying residual stenosis at an original site of the captured target clot in the vessel;
advancing the guidewire and microcatheter back into the vessel coinciding with the detected underlying residual stenosis;
proximally withdrawing from the vessel the guidewire while maintaining in position the microcatheter in the vessel coinciding with the underlying residual stenosis;
while the self-expanding stentriever is in the compressed state with the semi-compliant balloon in the deflated state housed therein, reloading the single integrated intravascular device into the lumen of the microcatheter;
advancing the single integrated intravascular device through the lumen of the microcatheter using the pusher member so that the self-expanding stentriever coincides with the detected underlying residual stenosis;
proximally withdrawing from the vessel the microcatheter while the single integrated intravascular device is maintained within the vessel coinciding with the detected underlying residual stenosis; the self-expanding stentriever when unsheathed by the microcatheter automatically transitioning to the self-expanded state;
while the self-expanding stentriever is in the self-expanded state, dispensing under pressure inflation media through the inflation lumen of the pusher member inflating the semi-compliant balloon;
as the balloon inflates imposing radially outward force, transitioning the self-expanding stentriever from the self-expanded state to a hyper expanded state thereby dilating the vessel at the detected underlying residual stenosis while releasing or detaching the self-expanding stentriever from the pusher member.

4. The method according to claim 3 , wherein the releasing or detaching of the self-expanding stentriever from the pusher member comprises the step of:
as the semi-compliant balloon is inflated expanding radially outward the self-expanding stentriever to a hyper-expanded state, fracturing frangible sections of some of the multiple struts of the self-expanding stentriever disposed proximate the respective proximal and distal securement points so as to completely sever a detachable portion of the self-expanding stentriever free of the pusher member from that of remnant portions of the stentriever that remain secured to the pusher member at the respective proximal and distal securement points.

5. The method according to claim 3 , wherein the releasing or detaching of the self-expanding stentriever from the pusher member comprises the step of:
as the semi-compliant balloon is inflated, expanding radially outward the self-expanding stentriever to a hyper-expanded state and, in turn, foreshortening the distal and proximal ends of the self-expanding stentriever until freed from respective proximal and distal sleeves releasably securing the distal and proximal ends of the self-expanding stentriever to the pusher member.

6. The method according to claim 5 , wherein the proximal and distal ends of the self-expanding stentriever are releasable from the respective proximal and distal sleeves only when the semi-compliant balloon is inflated and the self-expanding stentriever is in the hyper-expanded state having a larger diameter than while in the self-expanded state.

7. The method according to claim 3 , further comprising the step of: collapsing the semi-compliant balloon by applying a negative pressure via the inflation lumen of the pusher member to expel the inflation media; wherein as the semi-compliant balloon collapses, the stentriever automatically transitioning from the hyper-expanded state back to the self-expanded state; and
while in the self-expanded state, maintaining the released or detached self-expanding stentriever i

Assignees

• Depuy Synthes Products Inc

Inventors

• Johnson Kirk

Classifications

• A61B2017/22061

  for spreading elements apart · CPC title

• A61F2/958

  Inflatable balloons for placing stents or stent-grafts · CPC title

• A61M25/104

  used for angioplasty · CPC title

• A61B2017/22002

  preventing restenosis · CPC title

• A61B17/221 Primary

  Gripping devices in the form of loops or baskets {for gripping calculi or similar types of obstructions (surgical snare instruments A61B17/32056)} · CPC title