Devices and methods for controlled delivery of a stent

Patent metadata

Field	Value
Publication number	US-2019247211-A1
Application number	US-201916275799-A
Country	US
Kind code	A1
Filing date	Feb 14, 2019
Priority date	Feb 15, 2018
Publication date	Aug 15, 2019
Grant date	—

Abstract

The present disclosure relates generally to the field of medical devices. In particular, the present disclosure relates to devices and methods for controlled delivery of a stent, such as a self-expanding stent, and more particularly for controlling the full deployment of a stent in incremental steps from a sheath and for controlling the reconstrainment of a stent in incremental steps within a sheath.

First claim

What is claimed is:

1 . A device for controlled delivery of a stent, comprising:
a handle; an elongate inner member having a proximal end and a distal end, the inner member disposed distal to the handle and configured to extend within a lumen of the stent: a constraining sheath having a proximal end and a distal end, the sheath extending about the inner member and operable with the inner member to constrain the stent therebetween; and a deployment assembly disposed within the handle, comprising:
an elongate deployment member having a proximal end, a distal end, and a deployment axis extending therealong, the distal end of the deployment member connected to the proximal end of the constraining sheath, wherein the assembly is operable to translate the elongate deployment member in incremental steps along the deployment axis in a first direction to at least partially deploy the stent, and is operable to translate the deployment member in incremental steps along the deployment axis in a second direction to at least partially constrain the stent.

2 . The device of claim 1 , wherein the deployment assembly further comprises:
a drive gear configured to engage the elongate deployment member; a drive shaft having a drive shaft axis perpendicular to the deployment axis, the drive shaft axially disposed through and coupled to the drive gear; a first gear axially disposed about and coupled to the drive shaft; a second gear axially disposed about and coupled to the drive shaft, the second gear spaced apart from the first gear along the drive shaft axis; a reversing gear in communication with the second gear; and a rack configured to alternately engage the first gear and the reversing gear

3 . The device of claim 2 , further comprising:
a first one-way bearing coupled to the first gear and axially disposed about and coupled to the drive shaft, the first bearing configured to prevent the first gear from imparting a rotary motion to the drive shaft that translates the deployment member in the first direction; and a second one-way bearing coupled to the second gear and axially disposed about and coupled to the drive shaft, the second bearing configured to prevent the second gear from imparting a rotary motion to the drive shaft that translates the deployment member in the second direction.

4 . The device of claim 2 , wherein the rack has a first length of teeth configured to engage the first gear and a second length of teeth configured to engage the reversing gear, wherein the first length and the second length are parallel to the deployment axis and to each other.

5 . The device of claim 4 , wherein the first length is spaced apart from the second length a distance that is different than the distance between the first gear and the second gear, such that the rack can only alternately engage the first length with the first gear or the second length with the reversing gear.

6 . The device of claim 2 , wherein the rack is moveable back and forth along a first axis parallel to the drive shaft axis to alternately engage one of the first gear and the reversing gear, and wherein the rack is moveable back and forth along a second axis parallel to the deployment axis to rotate one of the first gear and the reversing gear when alternately engaged therewith.

7 . The device of claim 6 , wherein the rack includes a trigger extending outside of the handle, the trigger engageable by a user to move the rack along the second axis, wherein movement of the rack along the second axis in a proximal direction when engaging the first gear translates to movement of the deployment member in the second direction, and wherein movement of the rack along the second axis in a proximal direction when engaging the reversing gear translates to movement of the deployment member in the first direction.

8 . The device of claim 7 , wherein the trigger has a starting position and the deployment assembly further comprises one or more springs cooperatively engaged with the rack to apply a biasing force onto the rack to return the trigger to the starting position.

9 . The device of claim 1 , wherein translating the elongate deployment member in the first direction at least partially deploys the stent from within the sheath.

10 . The device of claim 6 , wherein the rack is moveable in the proximal direction along the second axis a predetermined stroke length.

11 . The device of claim 10 , wherein the stroke length is less than the length of the stent.

12 . A system for controlled stent delivery comprising:
a self-expanding stent; an elongate inner member having a proximal end and a distal end, the inner member disposed distal to the handle and configured to extend within a lumen of the stent: a constraining sheath having a proximal end and a distal end, the sheath extending about the inner member and operable with the inner member to constrain the stent therebetween; and a handle containing a deployment assembly, the deployment assembly comprising:
an elongate deployment member having a proximal end, a distal end, and a deployment axis extending therealong, the distal end of the deployment member connected to a proximal end of the constraining sheath, wherein the assembly is operable to translate the deployment member in incremental steps along the deployment axis in a first direction to at least partially deploy the stent, and is operable to translate the deployment member in incremental steps along the deployment axis in a second direction to at least partially constrain the stent.

13 . The system of claim 12 , wherein the deployment assembly further comprises:
a drive gear configured to engage the elongate deployment member; a drive shaft, having a drive shaft axis perpendicular to the deployment axis, the drive shaft axially disposed through and coupled to the drive gear; a first gear axially disposed about and coupled to the drive shaft; a second gear axially disposed about and coupled to the drive shaft, the second gear spaced apart from the first gear along the drive shaft axis; a reversing gear in communication with the second gear; a rack configured to alternately engage the first gear and the reversing gear; and a trigger configured to translate the rack proximally and distally.

14 . The system of claim 13 , further comprising:
a first one-way bearing coupled to the first gear and axially disposed about and coupled to the drive shaft, the first bearing configured to prevent the first gear from imparting a rotary motion to the drive shaft that translates the deployment member in the first direction; and a second one-way bearing coupled to the second gear and axially disposed about and coupled to the drive shaft, the second bearing configured to prevent the second gear from imparting a rotary motion to the drive shaft that translates the deployment member in the second direction.

15 . The system of claim 13 , wherein the rack is moveable back and forth along a first axis parallel to the drive shaft axis to alternately engage one of the first gear and the reversing gear, and wherein the rack is moveable back and forth along a second axis parallel to the deployment axis to rotate one of the first gear and the reversing gear when alternately engaged therewith.

16 . The system of claim 15 , wherein the rack is moveable in the proximal direction along the second axis a predetermined stroke length.

17 . A method of delivering a stent comprising:
inserting a stent into a patient to a deployment location, the stent disposed on an inner member and constrained within a sh

Assignees

• Boston Scient Scimed Inc

Inventors

• Gilmartin Gary
• Toner Geraldine A
• Mcnern Louis
• Folan Martyn
• MONTAGUE Matthew
• Ralph Carmel
• Bhreathnach Maire
• Connaughton Enda
• Hynes Martin

Classifications

• A61F2/9517

  handle assemblies therefor · CPC title

• A61F2002/9534

  for repositioning of stents · CPC title

• A61M25/0113

  Mechanical advancing means, e.g. catheter dispensers · CPC title

• A61M2205/103

  rotating · CPC title

• A61F2002/9517

  Human Necessities · mapped topic