SLEEVE FOR FACILITATING MOVEMENT OF A TRANSFEMORAL CATHETER

• US 20140005768A1
• Filed: 08/17/2011
• Published: 01/02/2014
• Est. Priority Date: 08/17/2010
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Thomas, Ralph Joseph, Wang, Huisun, Daly, Jacob John, Savard, Thomas A.
• Granted Patent: US 10,130,470 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0668 splittable, tear apart

Abstract

A delivery device (10) for an implantable medical device includes an inner shaft (26) extending in a longitudinal direction and defining a compartment (23) adapted to receive the medical device in an assembled condition, an outer shaft (22) surrounding a longitudinal portion of the inner shaft, and a distal sheath (24) operatively attached to the outer shaft (22). The distal sheath (24) is slidable between a first position enclosing the compartment (23) and a second position exposing the compartment (23) for deployment of the medical device. A sleeve 30 surrounds at least a longitudinal portion of the outer shaft (22) and provides a substantially blood tight bearing surface that facilitates sliding movement of the delivery device (10) in an introducer (2).

Claims

1. A delivery device for an implantable medical device, the delivery device comprising:

an inner shaft extending in a longitudinal direction, the inner shaft defining a compartment adapted to receive the medical device in an assembled condition;

an outer shaft surrounding at least a longitudinal portion of the inner shaft, the outer shaft being slidable relative to the inner shaft in the longitudinal direction;

a distal sheath operatively attached to the outer shaft and surrounding a longitudinal portion of the inner shaft, the distal sheath having an outer diameter and being slidable in the longitudinal direction between a first position enclosing the compartment and a second position exposing the compartment for deployment of the medical device; and

a sleeve surrounding at least a longitudinal portion of the outer shaft, the sleeve having an inner diameter less than the outer diameter of the distal sheath.

2. The delivery device of claim 1, wherein the sleeve and the outer shaft define an average clearance therebetween of between about 0.001 inches and about 0.002 inches.

3. The delivery device of claim 1, further comprising a handle coupled to the inner and outer shafts and adapted to slide the outer shaft in the longitudinal direction relative to the inner shaft.

4. The delivery device of claim 1, wherein the sleeve is configured to be non-removable from the outer shaft.

5. The delivery device of claim 1, wherein the sleeve is splittable in the longitudinal direction for removal from the outer shaft.

6. The delivery device of claim 1, wherein the sleeve has an outer surface that tapers in the longitudinal direction from a relatively large proximal diameter to a relatively small distal diameter.

7. The delivery device of claim 1, wherein the sleeve includes a distal steerable portion and a proximal portion, the steerable portion being more flexible than the proximal portion.

8. The delivery device of claim 7, further comprising a steering actuator coupled to the sleeve, wherein operation of the steering actuator bends the steerable portion of the sleeve.

9. The delivery device of claim 8, further comprising a pull-wire extending in the longitudinal direction from the steering actuator to a distal end of the steerable portion, whereby operation of the steering actuator causes the pull-wire to pull on the distal end of the steerable portion.

10. A system for implantable medical device delivery, the system comprising:

an introducer having an interior lumen and an introducer valve located in the interior lumen; and

a delivery device including

an inner shaft extending in a longitudinal direction, the inner shaft defining a compartment adapted to receive the medical device in an assembled condition;

an outer shaft surrounding at least a longitudinal portion of the inner shaft, the outer shaft being slidable relative to the inner shaft in the longitudinal direction;

a distal sheath operatively attached to the outer shaft and surrounding a longitudinal portion of the inner shaft, the distal sheath being slidable in the longitudinal direction between a first position enclosing the compartment and a second position exposing the compartment for deployment of the medical device; and

a sleeve surrounding at least a longitudinal portion of the outer shaft;

the delivery device being assembled in the introducer so that the sleeve is positioned in the interior lumen of the introducer and extends through the introducer valve.

11. The system of claim 10, wherein the sleeve and the outer shaft define an average clearance therebetween of between about 0.001 inches and about 0.002 inches.

12. The system of claim 10, wherein the delivery device includes a handle coupled to the inner and outer shafts and adapted to slide the outer shaft in the longitudinal direction relative to the inner shaft.

13. The system of claim 10, wherein the sleeve is configured to be non-removable from the outer shaft.

14. The system of claim 10, wherein the sleeve is splittable in the longitudinal direction for removal from the outer shaft.

15. The system of claim 10, wherein the sleeve has an outer surface that tapers in the longitudinal direction from a relatively large proximal diameter to a relatively small distal diameter.

16. The system of claim 10, wherein the sleeve includes a distal steerable portion and a proximal portion, the steerable portion being more flexible than the proximal portion.

17. The system of claim 16, wherein the delivery device includes a steering actuator coupled to the sleeve, whereby operation of the steering actuator bends the steerable portion of the sleeve.

18. The system of claim 17, wherein the delivery device includes a pull-wire extending in the longitudinal direction from the steering actuator to a distal end of the steerable portion, whereby operation of the steering actuator causes the pull-wire to pull on the distal end of the steerable portion.

19. A method of delivering an implantable medical device, comprising:

providing a delivery device including an inner shaft extending in a longitudinal direction, the inner shaft defining a compartment adapted to receive the medical device in an assembled condition, an outer shaft surrounding at least a longitudinal portion of the inner shaft, the outer shaft being slidable relative to the inner shaft in the longitudinal direction, a distal sheath operatively attached to the outer shaft and surrounding a longitudinal portion of the inner shaft, the distal sheath being slidable in the longitudinal direction between a first position enclosing the compartment and a second position exposing the compartment for deployment of the medical device, and a sleeve surrounding at least a longitudinal portion of the outer shaft;

mounting the medical device in the compartment with the distal sheath in the first position;

providing an introducer in a tract extending from an opening in a blood vessel of a patient and through tissue overlying the opening, the introducer having an interior lumen and an introducer valve located in the interior lumen;

inserting the distal sheath of the delivery device into the patient through the introducer to position the medical device at a target location;

positioning the sleeve in the introducer, the introducer valve creating a substantially leak-proof seal against an outer surface of the sleeve;

advancing the distal sheath of the delivery device into the aortic arch of the patient; and

deploying the medical device by withdrawing a proximal portion of the outer shaft out of the introducer, thereby sliding the distal sheath into the second position.

20. The method of claim 19, wherein the medical device is a prosthetic heart valve, and the target location is the descending aorta.

21. The method of claim 19, further comprising removing the sleeve from the introducer by splitting it along a pre-determined longitudinal score and peeling the sleeve away from the outer shaft.

22. The method of claim 19, wherein the sleeve includes a distal steerable portion and a proximal portion, the steerable portion being more flexible than the proximal portion, and the delivery device includes a steering actuator coupled to the sleeve, the method further comprising:

operating the steering actuator to bend the steerable portion of the sleeve.

23. The method of claim 22, wherein the delivery device includes a pull-wire extending in the longitudinal direction from the steering actuator to a distal end of the steerable portion, the method further comprising:

operating the steering actuator to cause the pull-wire to pull on the distal end of the steerable portion, thereby bending the deflectable portion.