Sleeve for facilitating movement of a transfemoral catheter

• US 10,130,470 B2
• Filed: 08/17/2011
• Issued: 11/20/2018
• Est. Priority Date: 08/17/2010
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Inventors: Thomas, Ralph Joseph, Wang, Huisun, Daly, Jacob John, Savard, Thomas A.
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): Hollm, Jonathan
• Application Number:
  US13/817,056
• Publication Number:
  US 20140005768A1
• Time in Patent Office: 2,652 Days
• Field of Search: 623 111- 113, 623 124, 623 211, 606 1, 606108, 606191-200, 604528, 600146-150
• 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, the outer shaft including a hemostasis valve at a proximal end thereof having an adjustable sealing member and a side port for flushing the space between the outer shaft and the inner shaft;

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 a longitudinal portion of the outer shaft and extending from a location close to the hemostasis valve to a location close to the distal sheath but sufficiently spaced from the distal sheath that the distal sheath is configured to be fully retracted off of the compartment without contacting the sleeve, the hemostasis valve being disposed proximal to a proximal end of the sleeve, the sleeve having an inner diameter less than the outer diameter of the distal sheath, the sleeve being slidably assembled over the outer shaft distally of the hemostasis valve and proximally of the distal sheath, the sleeve configured to have a range of motion during delivery of the implantable medical device into a patient, the range of motion limited proximally by the hemostasis valve and limited distally by the distal sheath, the sleeve configured to be slidable relative to the outer shaft, the inner shaft, and the hemostasis valve during delivery of the implantable medical device into a patient wherein the sleeve includes a hub having an outer diameter sized and configured to be greater than an inner diameter of an interior lumen of an introducer comprising an introducer valve, so that the hub is configured to prevent the sleeve from fully passing into the introducer and from fully passing through the introducer valve,

wherein the inner diameter of the sleeve is closely matched with an outer diameter of the outer shaft, such that a gap between the sleeve and the outer shaft is sufficiently small that the gap is configured to prevent significant flow of blood into the gap.

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, the outer shaft including a hemostasis valve at a proximal end thereof having an adjustable sealing member and a side port for flushing the space between the outer shaft and the inner shaft;

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 a longitudinal portion of the outer shaft and extending from a location close to the hemostasis valve to a location close to the distal sheath but sufficiently spaced from the distal sheath that the distal sheath is configured to be fully retracted off of the compartment without contacting the sleeve, the hemostasis valve being disposed proximal to a proximal end of the sleeve, the sleeve being slidably assembled over the outer shaft distally of the hemostasis valve and proximally of the distal sheath, the sleeve configured to have a range of motion during delivery of the implantable medical device into a patient, the range of motion limited proximally by the hemostasis valve and limited distally by the distal sheath, the sleeve configured to be slidable relative to the outer shaft, the inner shaft, and the hemostasis valve during delivery of the implantable medical device into a patient, wherein an inner diameter of the sleeve is closely matched with an outer diameter of the outer shaft, such that a gap between the sleeve and the outer shaft is sufficiently small that the gap is configured to prevent significant flow of blood into the gap wherein the sleeve includes a hub having an outer diameter that is greater than an inner diameter of the interior lumen of the introducer, so that the hub is configured to prevent the sleeve from fully passing into the introducer and from fully passing through the introducer valve;

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, the outer shaft including a hemostasis valve at a proximal end thereof having an adjustable sealing member and a side port for flushing the space between the outer shaft and the inner shaft, 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 a longitudinal portion of the outer shaft and extending from a location close to the hemostasis valve to a location close to the distal sheath but sufficiently spaced from the distal sheath that the distal sheath is configured to be fully retracted off of the compartment without contacting the sleeve, the hemostasis valve being disposed proximal to a proximal end of the sleeve, the sleeve being slidably assembled over the outer shaft distally of the hemostasis valve and proximally of the distal sheath, the sleeve configured to have a range of motion during delivery of the implantable medical device into a patient, the range of motion limited proximally by the hemostasis valve and limited distally by the distal sheath, the sleeve configured to be slidable relative to the outer shaft, the inner shaft, and the hemostasis valve during delivery of the implantable medical device into a patient, wherein an inner diameter of the sleeve is closely matched with an outer diameter of the outer shaft, such that a gap between the sleeve and the outer shaft is sufficiently small that the gap is configured to prevent significant flow of blood into the gap;

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 the patient and through tissue overlying the opening, the introducer having an interior lumen and an introducer valve located in the interior lumen wherein the sleeve includes a hub having an outer diameter that is greater than an inner diameter of the interior lumen of the introducer, so that the hub is configured to prevent the sleeve from fully passing into the introducer and from fully passing through the introducer valve;

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 with the hemostasis valve disposed proximally of the introducer and the distal sheath disposed distally of 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.