Delivery device and method of delivery

Patent metadata

Field	Value
Publication number	US-11660218-B2
Application number	US-201816632841-A
Country	US
Kind code	B2
Filing date	Jul 24, 2018
Priority date	Jul 26, 2017
Publication date	May 30, 2023
Grant date	May 30, 2023

Abstract

A delivery device can provide sequential delivery of a plurality of intraluminal devices held in a compressed state on the delivery device. Delivery platforms on the delivery device can hold an intraluminal device in a compressed position and be positioned between pusher bands that may also be radiopaque markers. A post deployment dilation device can be included. The post deployment dilation device can be a plurality of expansion filaments, a bellows, or a balloon. An intravascular device deployment method can include allowing a self-expanding intravascular device to expand, aligning the post deployment dilation device under the intravascular device, and causing the post deployment dilation device to expand radially to push outward on the intravascular device.

First claim

What is claimed is:

1. A delivery device comprising:
an inner shaft configured to receive a self-expanding intraluminal device for deployment from the delivery device into a vessel;
an outer sheath outward of the inner shaft and movable with respect to the inner shaft, the outer sheath having a pre-deployment position in which the self-expanding intraluminal device is covered and a delivery position in which the self-expanding intraluminal device is uncovered to release the self-expanding intraluminal device from the delivery device;
a post-deployment dilation device comprising:
a balloon attached to the outer sheath of the delivery device, the balloon having a pre-actuated configuration having a pre-deployment diameter and an actuated configuration having a deployment diameter larger than the pre-deployment diameter;
a single helical filament wrapped around the balloon in a pre-deployment configuration; and
one or more inflation lumens contained in the outer sheath and in fluid communication with the balloon;

a distal radiopaque marker adjacent a distal end of the balloon, wherein the distal radiopaque marker is spaced from a distal end of the outer sheath; and
a proximal radiopaque marker adjacent a proximal end of the balloon;
wherein the post deployment dilation device is configured to apply a radial force to an inner surface of the self-expanding intraluminal device after deployment of the self expanding intraluminal device to improve at least one of expansion of the self-expanding intraluminal device or seating of the self-expanding intraluminal device in the vessel, and
wherein the inner shaft includes a helical filament lumen, the single helical filament configured to be retracted into the helical filament lumen to release the balloon of the post-deployment dilation device.

2. The delivery device of claim 1 , further comprising a pressure sensor configured to detect a pressure within the balloon and configured to communicate with an inflation device in fluid communication with the balloon and provide instructions to the inflation device such that the inflation device does not inflate the balloon past a set threshold.

3. The delivery device of claim 1 , wherein a length of the balloon is the same as a length of the self-expanding intraluminal device.

4. The delivery device of claim 1 , wherein the outer sheath comprises a guidewire lumen comprising an exit aperture distal to a proximal end of the outer sheath.

5. The delivery device of claim 1 , wherein the one or more inflation lumens comprise two inflation lumens, the delivery device further comprising a pressure sensor configured to detect a pressure within the balloon and configured to communicate with an inflation device in fluid communication with the balloon and provide instructions to the inflation device such that the inflation device does not inflate the balloon past a set threshold, wherein a length of the balloon is the same as a length of the self-expanding intraluminal device, wherein the outer sheath comprises a guidewire lumen comprising an exit aperture distal to a proximal end of the outer sheath, and wherein each of the two inflation lumens is oblong.

6. The delivery device of claim 1 , wherein the single helical filament is configured to release the balloon in a deployment configuration in which the balloon is inflated.

7. The delivery device of claim 1 , wherein the outer sheath includes an outer sheath inner tube and an outer sheath outer tube and the balloon is attached to both the outer sheath inner tube and the outer sheath outer tube.

8. The delivery device of claim 1 , wherein the single helical filament is further configured to be extended out of the helical filament lumen to cause the single helical filament to wrap helically around the balloon to trap the balloon.

9. A delivery device comprising:
an inner shaft configured to receive a self-expanding intraluminal device for deployment from the delivery device into a vessel;
an outer sheath outward of the inner shaft and movable with respect to the inner shaft, the outer sheath having a pre-deployment position in which the self-expanding intraluminal device is covered and a delivery position in which the self-expanding intraluminal device is uncovered to release the self-expanding intraluminal device from the delivery device;
a post-deployment dilation device comprising:
a balloon attached to the outer sheath of the delivery device, the balloon having a pre-actuated configuration having a pre-deployment diameter and an actuated configuration having a deployment diameter larger than the pre-deployment diameter;
a helical filament wrapped around the balloon in a pre-deployment configuration and retractable into a helical filament lumen of the inner shaft to release the balloon in a deployment configuration in which the balloon is inflated; and
one or more inflation lumens contained in the outer sheath and in fluid communication with the balloon;

a distal radiopaque marker adjacent a distal end of the balloon, wherein the distal radiopaque marker is spaced from a distal end of the outer sheath; and
a proximal radiopaque marker adjacent a proximal end of the balloon;
wherein the post deployment dilation device is configured to apply a radial force to an inner surface of the self-expanding intraluminal device after deployment of the self-expanding intraluminal device to improve at least one of expansion of the self-expanding intraluminal device or seating of the self-expanding intraluminal device in the vessel.

10. The delivery device of claim 9 , wherein the helical filament is further configured to be extended out of the helical filament lumen to cause the helical filament to wrap helically around the balloon to trap the balloon.

11. A delivery device comprising:
an inner shaft configured to receive a self-expanding intraluminal device for deployment from the delivery device into a vessel;
an outer sheath outward of the inner shaft and movable with respect to the inner shaft, the outer sheath having a pre-deployment position in which the self-expanding intraluminal device is covered and a delivery position in which the self-expanding intraluminal device is uncovered to release the self-expanding intraluminal device from the delivery device; and
a post-deployment dilation device comprising:
a balloon attached to the outer sheath of the delivery device, the balloon having a pre-actuated configuration having a pre-deployment diameter and an actuated configuration having a deployment diameter larger than the pre-deployment diameter;
a helical filament wrapped around the balloon in a pre-deployment configuration and retractable into a helical filament lumen of the inner shaft to release the balloon in a deployment configuration in which the balloon is inflated; and
one or more inflation lumens contained in the outer sheath and in fluid communication with the balloon.

12. The delivery device of claim 11 , wherein the helical filament is further configured to be extended out of the helical filament lumen to cause the helical filament to wrap helically around the balloon to trap the balloon.

13. The delivery device of claim 11 wherein the post deployment dilation device is configured to apply a radial force to an inner surface of the self-expanding intraluminal device after deployment of the self-expanding intraluminal device to improve at least one of expansion of the self-expanding intraluminal device or seating of the self-expanding intraluminal device in the vessel.

14. The delivery device of claim 11 further comprising:
a distal radiopaque marker adjacent a distal end of the balloon

Assignees

• Intact Vascular Inc

Inventors

• Longo Michael
• Horzewski Michael

Classifications

• A61F2250/0098

  radio-opaque, e.g. radio-opaque markers · CPC title

• A61F2/962

  having an outer sleeve · CPC title

• A61M25/01

  Introducing, guiding, advancing, emplacing or holding catheters (A61M25/10 takes precedence) · CPC title

• A61M2025/0183

  Rapid exchange or monorail catheters · CPC title

• A61F2/958 Primary

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