Delivery device with shortened inner tube and associated method

• US 8,986,360 B2
• Filed: 05/12/2006
• Issued: 03/24/2015
• Est. Priority Date: 05/13/2005
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Mangiardi, Eric K., Reynolds, Jason M., Reuther, Jeff
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): TON, MARTIN TRUYEN
• Application Number:
  US11/432,964
• Publication Number:
  US 20070043421A1
• Time in Patent Office: 3,238 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.23, 606/108, 606/194, 606/198
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• 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 2250/0091 transparent or translucent
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system

Abstract

A delivery device for positioning and deploying an implantable device within a lumen is provided. The device includes a longitudinal outer tube having proximal and distal ends, wherein the implantable device is positioned proximate to the distal end of the outer tube. The device also includes a longitudinal inner tube slidably disposed within the outer tube and having proximal and distal ends, wherein at least a portion of the distal end of the inner tube is configured to underlie at least a portion of a proximal end of the implantable device. The distal end of the inner tube is located proximally of the distal end of the outer tube to define a gap for accommodating at least a portion of the implantable device. A mechanism is coupled to the inner and/or outer tubes and is operable to deploy the implantable device within the lumen.

Claims

1. A delivery device for positioning and deploying an implantable device within a lumen comprising:

a longitudinal outer tube having a proximal end and a distal end, wherein the outer tube is configured to receive the implantable device at a position within the outer tube and proximate to the distal end of the outer tube;

a longitudinal inner tube slidably disposed within the outer tube and having a proximal end and a distal end, wherein at least a portion of the distal end of the inner tube is configured to underlie a proximal end of the implantable device about an inner circumference of the implantable device, and wherein the distal end of the inner tube is located proximally of the distal end of the outer tube to define a gap for accommodating at least a portion of the implantable device;

a deployment mechanism coupled to at least one of the inner and outer tubes and operable to deploy the implantable device within the lumen, wherein the deployment mechanism comprises;

a first actuator to at least partially move the outer tube proximally and longitudinally relative to the inner tube,

a connector connected to the first actuator, and

a second actuator positioned proximal to the first actuator and operatively connected to the first actuator via the connector to move the outer tube proximally and longitudinally relative to the inner tube,

wherein the first actuator and the second actuator are configured to be retracted in succession to provide staged deployment of the implantable device such that retracting the second actuator moves the first actuator and the outer tube proximally and longitudinally relative to the inner tube from a first position to a second position to cause partial deployment of the implantable device and subsequent retraction of the first actuator slidably and proximally within the connector toward the second actuator moves the outer tube proximally and longitudinally relative to the inner tube from the second position to a third position to cause full deployment of the implantable device; and

an optical device configured to be positioned within the gap to view at least a portion of an interior of the implantable device within the outer tube prior to deployment of the implantable device.

2. The delivery device according to claim 1, wherein the optical device is capable of being positioned within the gap to view at least a portion of the lumen proximate to a target deployment area.

3. The delivery device according to claim 1, wherein each of the inner and outer tubes comprises a side opening defined therein, and wherein the outer tube is capable of sliding over the inner tube to substantially align each of the side openings with one another.

4. The delivery device according to claim 1, wherein each of the inner and outer tubes comprises a coil positioned therein.

5. The delivery device according to claim 4, wherein the coil of the inner tube extends proximate to its distal end, and wherein the coil of the outer tube extends proximally of its distal end such that the coils are capable of aligning with one another prior to deploying the implantable device.

6. The delivery device according to claim 1, wherein at least one of the inner and outer tubes comprises a semi-transparent polymeric material.

7. The delivery device according to claim 6, wherein the polymeric material comprises at least one of polytetrafluoroethylene and polyether block amide.

8. The delivery device according to claim 6, wherein the outer tube comprises a semi-transparent polymeric material and the inner tube comprises a side opening defined therein, and wherein the optical instrument is capable of viewing the lumen through the side opening and the outer tube.

9. The delivery device according to claim 1, further comprising a distal portion coupled to the inner tube with a collar, wherein the distal portion is configured to underlie the proximal end of the implantable device about the inner circumference of the implantable device.

10. The delivery device according to claim 9, wherein the distal portion comprises at least one anchor extending outwardly therefrom and configured to interiorly engage at least a portion of the proximal end of the implantable device.

11. The delivery device according to claim 1, wherein the first actuator is directly coupled to the outer tube.

22. The delivery device of claim 9, wherein the collar has a larger outer diameter then the inner tube.

26. The delivery device of claim 1, wherein the connector comprises an aperture and the second actuator is configured to slide proximally within the aperture to fully deploy the implantable device.

12. A method for deploying an implantable device within a lumen proximate to a target area comprising:

obtaining a delivery device including an inner tube within an outer tube such that a gap is defined between respective distal ends of each of the inner and outer tubes and an implantable device positioned at least partially within the gap with at least a portion of the distal end of the inner tube interiorly within the implantable device such that the inner tube underlies the implantable device about an inner circumference thereof;

positioning the inner and outer tubes within the lumen proximate to the target area;

positioning an optical device within the gap to view at least a portion of at least one of the implantable device and the target area from within the outer tube prior to deployment of the implantable device;

retracting a proximal actuator of a deployment mechanism of the delivery device, the proximal actuator operably connected via a connector to a distal actuator that is operably connected to the outer tube of the delivery device, wherein the proximal actuator and the distal actuator of the deployment device are configured to be retracted in succession to provide staged deployment of the implantable device, wherein retracting the proximal actuator moves the distal actuator and the outer tube proximally and longitudinally relative to the inner tube and thereby at least partially moves the outer tube proximally and longitudinally relative to the inner tube from a first position to a second position to cause partial deployment of the implantable device; and

retracting the distal actuator of the deployment mechanism slidably and proximally within the connector toward the proximal actuator, subsequent to retracting the proximal actuator, to move the outer tube proximally and longitudinally relative to the inner tube, from the second position to a third position, to cause full deployment of the implantable device.

13. The method according to claim 12, wherein the implantable device is positioned over at least one anchor extending outwardly from the distal end of the inner tube such that the at least one anchor interiorly engages the implantable device.

14. The method according to claim 12, further comprising moving the inner and outer tubes proximally within the lumen while the implantable device is positioned within the gap to reposition the implantable device.

15. A delivery device for positioning and deploying an implantable device within a lumen comprising:

a longitudinal outer tube having a proximal end and a distal end, wherein at least a portion of the implantable device is disposed in direct contact with the outer tube proximate to the distal end of the outer tube prior to deploying the implantable device;

a shortened inner tube slidably disposed within the outer tube and having a proximal end and a distal end, wherein at least a portion of the distal end of the inner tube comprises at least one anchor extending outwardly from the inner tube and configured to interiorly engage at least a portion of a proximal end of the implantable device; and

a deployment mechanism coupled to at least one of the inner and outer tubes and operable to deploy the implantable device within the lumen, wherein the deployment mechanism comprises;

a distal actuator to at least partially move the outer tube proximally and longitudinally relative to the inner tube,

a connector coupled to the distal actuator, and

a proximal actuator positioned proximal to the distal actuator and operably connected to the distal actuator via the connector to move the outer tube proximally and longitudinally relative to the inner tube,

wherein the distal actuator and the proximal actuator are configured to be retracted in succession to provide staged deployment of the implantable device such that retracting the proximal actuator moves the distal actuator and the outer tube proximally and longitudinally relative to the inner tube from a first position to a second position to cause partial deployment of the implantable device and subsequent retraction of the distal actuator slidably and proximally within the connector toward the proximal actuator moves the outer tube proximally and longitudinally relative to the inner tube from the second position to a third position to cause full deployment of the implantable device; and

an optical device configured to be positioned to view at least a portion of an interior of the implantable device within the outer tube prior to deployment of the implantable device.

16. The delivery device according to claim 15, wherein the distal end of the inner tube is located proximally of the distal end of the outer tube to define a gap for accommodating at least a portion of the implantable device.

17. The delivery device according to claim 16, wherein the optical device is configured to be positioned within the gap to view the at least a portion of the interior of the implantable device and to view at least a portion of the lumen.

18. The delivery device according to claim 15, wherein the inner tube further comprises a distal portion coupled thereto with a collar, wherein the distal portion is configured to underlie at least a portion of the proximal end of the implantable device.

19. The delivery device according to claim 18, wherein the distal portion comprises the at least one anchor.

20. The delivery device according to claim 15, wherein at least one of the inner and outer tubes comprises a semi-transparent polymeric material.

21. The delivery device according to claim 20, wherein the outer tube comprises a semi-transparent polymeric material and the inner tube comprises a side opening defined therein, and wherein an optical instrument is capable of viewing the lumen through the side opening and the outer tube.

23. The delivery device of claim 15, wherein the inner tube comprises a plurality of anchors spaced circumferentially apart from one another.

24. The delivery device of claim 15, wherein the at least one anchor comprises a protuberance extending outwardly from an outer surface of the inner tube.

25. The delivery device of claim 18, wherein the collar has a larger outer diameter than the inner tube.