Controlled expansion stent graft delivery system

Patent metadata

Field	Value
Publication number	US-10463517-B2
Application number	US-201715822760-A
Country	US
Kind code	B2
Filing date	Nov 27, 2017
Priority date	Jan 16, 2017
Publication date	Nov 5, 2019
Grant date	Nov 5, 2019

Abstract

A controlled expansion stent graft delivery system has an adjustment configuration in which a retractable sheath is at a retracted position out of contact with a stent graft, but expansion of the stent graft is controlled by a control tether, which has a middle segment wrapped around a fabric tube of the stent graft. The stent graft changes diameter responsive to a tension level in the control tether. At least one of an orientation and a position of the stent graft may be adjusted during controlled expansion via the control tether.

First claim

What is claimed is:

1. A controlled expansion stent graft delivery system comprising:
a delivery catheter with a tip that includes a tether clamp, and defining a longitudinal axis;
a retractable sheath;
a stent graft that includes a fabric tube attached to, and supported by, a self expanding stent;
a handle attached to the delivery catheter at an end opposite to the tip;
a control tether attached to an axial movement actuator mounted to the handle;
the delivery system having a delivery configuration in which the stent graft is mounted on the delivery catheter in a compressed state and covered by the retractable sheath;
the delivery system having an adjustment configuration in which the retractable sheath is at retracted position out of contact with the stent graft; and the control tether is held by the tether clamp, wrapped completely around the longitudinal axis at a radially outward side of the fabric tube, and the axial movement actuator is at a second position with respect to the handle;
the delivery system having a release configuration in which the control tether is released from the tether clamp, wrapped around the stent graft, and the stent graft is in an expanded state;
the delivery system having a detached configuration in which the stent graft is in the expanded state and the control tether is out of contact with the stent graft; and
the axial movement actuator is at a first position with respect to the handle in at least one of the delivery configuration and the release configuration.

2. The delivery system of claim 1 wherein the axial movement actuator is at the first position with respect to the handle when the delivery system is in the release configuration; and
the expansion state of the stent graft being greater when the axial movement actuator is in the first position versus the second position.

3. The delivery system of claim 1 wherein the axial movement actuator is at the first position with respect to the handle when the delivery system is in the delivery configuration;
the expansion state of the stent graft being greater when the axial movement actuator is in the second position versus the first position.

4. The delivery system of claim 1 including a position lock moveable between an unlocked state at which the axial movement actuator can move away from one of the first position and the second position, and a locked state at which the axial movement actuator is locked at the one of the first position and the second position.

5. The delivery system of claim 1 including a clamp release line extending between the tether clamp and the handle, and being moveable between a clamp position at which the tether is held by the tether clamp, and a release position at which control tether is released from the tether clamp.

6. The delivery system of claim 1 wherein the tether clamp includes a spring operably positioned to bias the tether clamp toward a clamp position.

7. The delivery system of claim 1 including a clamp release lock positioned closer to the handle than to the tip, and being moveable between a first position at which a clamp release actuator is inoperable, and a second position at which the clamp release actuator is operable to move the tether clamp from a clamp position toward a release position.

8. The delivery system of claim 7 wherein the tether clamp includes a spring operably positioned to bias the tether clamp toward the clamp position; and
a clamp release line extending between the tether clamp and the handle, and being moveable between the clamp position at which the tether is held by the tether clamp, and the release position at which tether is released from the tether clamp.

9. The delivery system of claim 8 wherein the handle includes a longitudinal guide surface oriented parallel to the longitudinal axis; and
the guide surface constrains the axial movement actuator between the first position and the second position.

10. The delivery system of claim 9 including a position lock moveable between an unlocked state at which the axial movement actuator can move away from the second position, and a locked state at which the axial movement actuator is locked at the second position.

11. The delivery system of claim 10 wherein the axial movement actuator is at the first position with respect to the handle when the delivery system is in the release configuration; and
the expansion state of the stent graft being greater when the axial movement actuator is in the first position versus the second position.

12. The delivery system of claim 11 wherein the axial movement actuator is at the first position with respect to the handle when the delivery system is in the delivery configuration;
the expansion state of the stent graft being greater when the axial movement actuator is in the second position versus the first position.

13. A method of operating a controlled expansion stent graft delivery system that includes a delivery catheter with a tip that includes a tether clamp, and defining a longitudinal axis; a retractable sheath; a stent graft that includes a fabric tube attached to, and supported by, a self expanding stent; a handle attached to the delivery catheter at an end opposite to the tip; a control tether attached to an axial movement actuator mounted to the handle, and the method comprising the steps of:
positioning the delivery system at a treatment site in a delivery configuration in which the stent graft is mounted on the delivery catheter in a compressed state and covered by the retractable sheath;
changing the delivery system to an adjustment configuration in which the retractable sheath is at retracted position out of contact with the stent graft; and the control tether is held by the tether clamp, wrapped completely around the longitudinal axis at a radially outward side of the fabric tube, and the axial movement actuator is at a second position with respect to the handle;
changing the delivery system to a release configuration in which the control tether is released from the tether clamp, wrapped around the stent graft, and the stent graft is in an expanded state; and
changing the delivery system to a detached configuration in which the stent graft is in the expanded state and the control tether is out of contact with the stent graft; and
the axial movement actuator is at a first position with respect to the handle in at least one of the delivery configuration and the release configuration.

14. The method of claim 13 including stopping expansion of the stent graft by positioning the axial movement actuator at the second position while the delivery system is in the adjustment configuration;
adjusting at least one of an orientation and a position of the stent graft while the expansion of the stent graft is stopped; and
resuming expansion of the stent graft by decreasing tension in the control tether by moving the axial adjustment actuator away from the second position.

15. The method of claim 13 including partially expanding the stent graft by moving the axial movement actuator from the first position to the second position when changing from the delivery configuration to the adjustment configuration.

16. The method of claim 13 including contracting the stent graft toward the compressed state by moving the axial movement actuator.

17. The method of claim 14 including adjusting at least one of an orientation and a position of the stent graft after contracting the stent graft toward the compressed state; and
resuming expansion of the stent graft by decreasing tension in the control tether by moving the ax

Assignees

• Cook Medical Technologies Llc

Inventors

• Bradway Ryan
• Baxter Charles
• Kratzberg Jarin

Classifications

• A61F2/9517

  handle assemblies therefor · CPC title

• A61F2/9522

  Means for mounting a stent or stent-graft onto or into a placement instrument · CPC title

• A61F2002/9511

  the retaining means being filaments or wires · CPC title

• A61F2/07

  Stent-grafts · CPC title

• A61F2002/9665

  with additional retaining means · CPC title