Sleeve for facilitating movement of a transfemoral catheter

Patent metadata

Field	Value
Publication number	US-10130470-B2
Application number	US-201113817056-A
Country	US
Kind code	B2
Filing date	Aug 17, 2011
Priority date	Aug 17, 2010
Publication date	Nov 20, 2018
Grant date	Nov 20, 2018

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 ).

First claim

The invention claimed is:

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 bei

Assignees

• Thomas Ralph Joseph
• Wang Huisun
• Daly Jacob John
• Savard Thomas A
• St Jude Medical Llc

Inventors

• Thomas Ralph Joseph
• Wang Huisun
• Daly Jacob John
• Savard Thomas A

Classifications

• A61F2/966 Primary

  with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod · CPC title

• A61M25/0054

  with regions for increasing flexibility · CPC title

• A61F2/2427 Primary

  Devices for manipulating or deploying heart valves during implantation · CPC title

• A61F2/2436

  Deployment by retracting a sheath · CPC title

• A61M2025/0175

  having telescopic features, interengaging nestable members movable in relations to one another · CPC title