Stent delivery systems and methods

• US 8,926,683 B2
• Filed: 12/07/2011
• Issued: 01/06/2015
• Est. Priority Date: 12/07/2010
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Gill, Darla, Snider, Rich, Eller, Zeke, Mottola, Jim, Robinson, Tom, Lyons, Brenda
• Primary Examiner(s): Woo, Julian W
• Assistant Examiner(s): PAEZ, LUCAS M
• Application Number:
  US13/313,929
• Publication Number:
  US 20120310320A1
• Time in Patent Office: 1,126 Days
• Field of Search: 606/108, 606/200, 623/1.11, 623/2.11
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

Apparatus, systems, and methods are provided for deploying an implantable device, such as a stent, within a lumen of a body of a patient. The delivery device may include an inner member and an outer sheath surrounding a distal portion of the inner member and configured to retain the implantable device sheathed near the distal end of the outer sheath until deployment. The outer sheath is slidably moveable relative to the inner member such that proximal movement of the outer sheath relative to the inner member deploys the implantable device. A trigger assembly of the delivery device can include an internal connector coupled to the outer sheath, a plurality of triggers, and a floater coupling two of the triggers. The triggers are serially retracted to deploy the stent. A panchor secures the stent against proximal and distal movement relative to the inner member during deployment.

Claims

1. A delivery system for deploying an implantable device within a lumen internal to a body of a patient, the delivery system comprising:

an inner member having a proximal end coupled to a handle of the delivery system and extending toward a distal end of the delivery system to couple to the implantable device;

an outer sheath having a proximal end and a distal end, the outer sheath surrounding a distal portion of the inner member and configured to retain the implantable device sheathed near the distal end of the outer sheath until deployment, wherein the outer sheath is slidably moveable relative to the inner member such that proximal movement of the outer sheath relative to the inner member deploys the implantable device;

a trigger assembly coupled to the outer sheath comprising;

an internal connector coupled to the outer sheath and including a floater engagement surface;

a distal trigger configured to engage the internal connector to retract the internal connector as the distal trigger is retracted proximally;

a floater having a distal end and a proximal end, the distal end configured to engage a floater engagement surface of the internal connector to retract the internal connector as the floater is retracted proximally; and

a proximal trigger configured to engage the floater to retract the floater as the proximal trigger is retracted proximally,

wherein the distal trigger and the proximal trigger are configured to be serially retracted to provide staged release of the implantable device such that retracting the proximal trigger moves the distal trigger and the outer sheath proximally and longitudinally relative to the inner member from a first position to a second position to partially deploy the implantable device, and wherein subsequent retraction of the distal trigger moves the outer sheath proximally and longitudinally relative to the inner member from the second position to a third position to fully deploy the implantable device.

2. The delivery system of claim 1, wherein the internal connector has a tubular shape configured to surround a portion of the inner member, a distal end of the internal connector coupled to the proximal end of the outer sheath, wherein the internal connector is slidably moveable relative to the inner member and movement of the internal connector relative to the inner member results in movement of the outer sheath relative to the inner member;

wherein the distal trigger is configured to engage a proximal end of the internal connector as the distal trigger is retracted proximally toward the handle of the delivery system, wherein proximal movement of the distal trigger results in proximal movement of the internal connector and the outer sheath relative to the inner member;

wherein the floater has a tubular shape configured to surround a portion of the inner member, wherein the floater is slidably moveable relative to the inner member and proximal movement of the floater relative to the inner member results in proximal movement of the floater, the distal trigger, and the outer sheath relative to the inner member; and

wherein the proximal trigger is configured to engage a proximal end of the floater as the proximal trigger is retracted proximally toward the handle of the delivery system, wherein proximal movement of the proximal trigger results in proximal movement of each of the floater, the distal trigger, the internal connector, and the outer sheath relative to the inner member.

3. The delivery system of claim 2, wherein the implantable device is a stent, and wherein the inner member is configured to be disposed through the stent to couple to a conical tip,

wherein the stent is configured to be compressed and sheathed within a distal portion of the outer sheath.

4. The delivery system of claim 3, further comprising a panchor configured to couple to a proximal portion of the stent in a sheathed configuration, wherein the panchor is a combination pusher and anchor component configured to limit proximal and distal movement of the stent relative to the inner member.

5. The delivery system of claim 4,

wherein the stent comprises a scaffolding structure formed of a plurality of rows of struts or legs oriented about an outer circumference of the stent and connected by a plurality of connectors extending longitudinally with a longitudinal axis of the stent,

wherein the panchor comprises a push surface and an anchor, the push surface configured to restrict proximal movement of the stent relative to the inner member as the outer sheath is retracted proximally over the stent during deployment, the anchor including a flange configured to engage distal ends of one or more legs of a most proximal row of the plurality of rows of the stent and thereby restrict distal movement of the stent relative to the inner member.

6. The delivery system of claim 4, wherein the panchor is configured to push against the stent as a force in a proximal direction is exerted on the stent and is configured to anchor the stent as a force in a distal direction is exerted on the stent.

7. The delivery system of claim 1, wherein the floater is configured to telescope into the internal connector to allow the internal connector to move proximally relative to the floater and allow proximal movement of the distal trigger relative to the proximal trigger, to thereby enable serial retraction of the proximal trigger and then the distal trigger.

8. The delivery system of claim 7, wherein the internal connector comprises a floater engagement surface disposed at a proximal end of each of a pair of floater engagement channels, wherein the floater includes a pair of barbed prongs configured to slide distally within the floater engagement channels to enable the floater to telescope into the internal connector and to engage the floater engagement surface as the barbed prongs move proximally to the proximal end of the floater engagement channels, such that proximal movement of the floater results in proximal movement of the internal connector.

9. The delivery system of claim 1, further comprising a pod disposed at a distal end of the outer sheath, wherein the pod is configured to enclose the implantable device in a sheathed configuration until deployment, and wherein proximal movement of the outer sheath relative to the inner member results in proximal movement of the pod relative to the inner member to deploy the implantable device.

10. The delivery system of claim 1, further comprising one or more outer supports extending distally from the handle and configured to provide a support structure supporting the distal trigger and proximal trigger and along which the distal trigger and proximal trigger can slide as they are retracted to deploy the implantable device.

11. The delivery system of claim 10, wherein the one or more outer supports comprise an upper outer support and a lower outer support configured to mate together to form a tubular shaped housing around a portion of the proximal end of the outer sheath, the internal connector, the floater, and a proximal portion of the inner member.

12. The delivery system of claim 10, wherein the one or more outer supports are configured to form a trigger guide slot extending longitudinally along a length of the outer supports to provide a track or guide for the distal trigger and the proximal trigger as they move proximally relative to the one or more outer supports.

13. The delivery system of claim 10, wherein the outer supports provide one or more trigger safety notches configured to be engaged by a trigger safety to limit proximal movement of the distal trigger and the proximal trigger and thereby inhibit deployment of the implantable device.

14. The delivery system of claim 1, further comprising a trigger safety configured to engage the delivery system at one of a first trigger safety notch and a second trigger safety notch to restrict proximal movement of the distal trigger and outer sheath relative to the inner member.

15. The delivery system of claim 14, wherein the trigger safety is configured to engage one or more outer supports of the delivery system and configured to engage the internal connector to limit proximal movement of the internal connector relative to the one or more outer supports and inner member.

16. The delivery system of claim 14, wherein the trigger safety comprises:

a body having a closed configuration forming an annular shape configured to encircle and engage outer supports of the delivery system, the body having a hinge configured to allow the body to open and disengage from the outer supports of the delivery system, the body comprising;

an alignment rib disposed on an inner surface of the body and configured to engage protrusions on an internal connector and restrict proximal movement of the internal connector relative to the trigger safety; and

an inward protrusion extending inward from an inner surface of the body to engage a notch formed in the outer supports and configured to restrict proximal movement of the trigger safety relative to the outer supports; and

a release tab configured to open the body to release the trigger safety.

17. The delivery system of claim 1, further comprising a rigid support tube coupled to the handle and positioned around a proximal portion of the inner member, the rigid support tube configured to provide a rigid internal structure to support the distal trigger and the proximal trigger during proximal retraction.

18. The delivery system of claim 1, further comprising a third trigger positioned proximal to the proximal trigger and coupled to the proximal trigger, wherein the third trigger, the proximal trigger, and the distal trigger are configured to be serially retracted to provide staged release of the implantable device such that retracting the third trigger moves the proximal trigger, the distal trigger and the outer sheath proximally and longitudinally relative to the inner member from the first position to the second position to partially deploy the implantable device, and wherein subsequent retraction of the proximal trigger moves the distal trigger and the outer sheath proximally and longitudinally relative to the inner member from the second position to the third position to further partially deploy the implantable device, and wherein subsequent retraction of the distal trigger moves the outer sheath proximally and longitudinally relative to the inner member from the third position to a fourth position to fully deploy the implantable device.

19. The delivery system of claim 1, wherein the implantable device comprises a stent, and the delivery system further comprises:

an inner assembly disposed around a portion of the inner member, the inner assembly comprising a middle sheath configured around the inner member to provide additional structural support for the inner member against buckling, crimping, and undesired bending and collapse of the inner member, and the inner assembly further comprising a panchor disposed at the distal end of the middle sheath, wherein the panchor is a combination pusher and anchor configured to couple to a proximal portion of the stent to limit proximal and distal movement of the stent relative to the inner assembly.

20. The delivery system of claim 19, wherein the stent comprises a scaffolding structure formed of a plurality of rows of struts or legs oriented about an outer circumference of the stent and connected by a plurality of connectors extending longitudinally with a longitudinal axis of the stent, wherein the stent is configured to be compressed and sheathed within a distal portion of the outer sheath.

21. The delivery system of claim 20, wherein the panchor comprises a push surface and an anchor, the push surface configured to restrict proximal movement of the stent as the outer sheath is retracted proximally over the stent during deployment, the anchor including a flange configured to engage the distal ends of one or more legs of an annular segment of the stent and thereby restrict distal movement of the stent.

22. The delivery system of claim 19, wherein the floater comprises:

a tubular shape configured to surround a portion of the inner assembly;

a distal end; and

a proximal end,

wherein the distal end is configured to couple to the distal trigger as the floater is retracted proximally toward the handle of the delivery device,

wherein the proximal trigger is configured to engage the floater as the trigger is retracted proximally toward the handle,

wherein the floater is slidably moveable relative to the inner assembly and proximal movement of the floater relative to the inner assembly results in proximal movement of the floater, the distal trigger, and the outer sheath relative to the inner assembly and inner member, and

wherein the floater is configured to allow the distal trigger to be retracted proximally relative to the proximal trigger for serial retraction of the proximal trigger and the distal trigger.

23. The delivery system of claim 19, wherein the internal connector comprises:

a tubular shape configured to surround a portion of the inner assembly;

a distal end; and

a proximal end,

wherein the distal end is coupled to the proximal end of the outer sheath and the proximal end is configured to be engaged by the distal trigger as the distal trigger is retracted proximally toward the handle of the delivery device, and

wherein the internal connector is slidably moveable relative to the inner assembly and movement of the internal connector relative to the inner assembly results in movement of the outer sheath relative to the inner assembly and inner member.

24. The delivery system of claim 23, further comprising a trigger safety configured to engage the internal connector to restrict proximal movement of the distal trigger and outer sheath relative to the inner assembly and inner member.

25. The delivery system of claim 19, wherein the inner assembly further comprises a rigid support tube coupled to the handle of the delivery device and positioned around a proximal portion of the inner member, the rigid support tube configured to provide a rigid internal structure to support the proximal trigger and the distal trigger during retraction to deploy the stent.

26. A method of deploying a stent within a target lumen of a body of a patient, the method comprising:

obtaining a stent delivery system comprising a stent and a stent delivery device with the stent fully sheathed in a sheathed configuration within a distal portion of an outer sheath of the stent delivery system, the delivery system including a panchor disposed adjacent the distal end of the stent delivery system, wherein the panchor is a combination pusher and anchor configured to couple to a proximal portion of the stent to limit proximal and distal movement of the stent along with the outer sheath during deployment;

positioning a distal portion of the outer sheath, including the sheathed stent, within the target lumen;

retracting a proximal trigger to partially deploy the stent within the target lumen, wherein the proximal trigger is coupled to a floater to retract the floater as the proximal trigger is retracted proximally, the floater configured to engage a floater engagement surface of an internal connector to retract the internal connector as the floater is retracted proximally, the internal connector coupled to the outer sheath to retract the outer sheath as the internal connector is retracted proximally, the internal connector coupled to a distal trigger such that movement of the proximal trigger results in proximal movement of each of the distal trigger and the outer sheath relative to the stent to unsheathe a portion of the stent;

retracting the distal trigger to further retract the internal connector to further retract the outer sheath to fully deploy the stent within the target lumen, wherein proximal movement of the distal trigger results in proximal movement of the outer sheath relative to the inner member; and

withdrawing the distal portion of the outer sheath from the target lumen.

27. A delivery system for deploying an implantable device within a lumen internal to a body of a patient, the delivery system comprising:

an inner member having a proximal end coupled to a handle of the delivery system and extending toward a distal end of the delivery system to couple to the implantable device;

an outer sheath having a proximal end and a distal end, the outer sheath surrounding a distal portion of the inner member and configured to retain the implantable device sheathed near the distal end of the outer sheath until deployment, wherein the outer sheath is slidably moveable relative to the inner member such that proximal movement of the outer sheath relative to the inner member deploys the implantable device;

an internal connector having a tubular shape configured to surround a portion of the inner member and having a distal end and a proximal end and a floater engagement surface near the proximal end, the distal end coupled to the proximal end of the outer sheath, wherein the internal connector is slidably moveable relative to the inner member and movement of the internal connector relative to the inner member results in movement of the outer sheath relative to the inner member;

a distal trigger configured to engage a proximal end of the internal connector as the distal trigger is retracted proximally toward the handle of the delivery system, wherein proximal movement of the trigger results in proximal movement of the internal connector and the outer sheath relative to the inner member;

a floater having a tubular shape configured to surround a portion of the inner member and having a distal and a proximal end, the distal end configured to engage the floater engagement surface of the internal connector to retract the internal connector as the floater is retracted proximally, wherein the floater is slidably moveable relative to the inner member and proximal movement of the floater relative to the inner member results in proximal movement of the floater, the distal trigger, and the outer sheath relative to the inner member; and

a proximal trigger configured to engage a proximal end of the floater as the proximal trigger is retracted proximally toward the handle of the delivery system, wherein proximal movement of the proximal trigger results in proximal movement of each of the floater, the distal trigger, the internal connector, and the outer sheath relative to the inner member,

wherein the distal trigger and the proximal trigger are configured to be serially retracted to provide staged release of the implantable device such that retracting the proximal trigger moves the distal trigger and the outer sheath proximally and longitudinally relative to the inner member from a first position to a second position to partially deploy the implantable device, and wherein subsequent retraction of the distal trigger moves the outer sheath proximally and longitudinally relative to the inner member from the second position to a third position to fully deploy the implantable device.