Delivery device with viewing window and associated method

• US 7,731,654 B2
• Filed: 05/13/2005
• Issued: 06/08/2010
• Est. Priority Date: 05/13/2005
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Reuther, Jeff, Reynolds, Jason M., Mangiardi, Eric K.
• Primary Examiner(s): Dvorak; Linda C
• Assistant Examiner(s): Nia; Alireza
• Application Number:
  US11/128,509
• Publication Number:
  US 20060258972A1
• Time in Patent Office: 1,852 Days
• Field of Search: 600/104, 600/105, 600/130, 600/137, 600/114, 600/140, 600/164, 600/170, 623/1.11
• US Class Current: 600/130
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2250/0091 transparent or translucent

Abstract

A delivery device for positioning and deploying an implantable device within a lumen is provided. The device includes an inner tube positioned within an outer tube and capable of sliding therein, wherein the inner and outer tubes have proximal and distal ends. A side opening is defined in each of the inner and outer tubes, wherein each side opening is defined proximate to the implantable device and is capable of substantially aligning with the other side opening. The device includes an optical device capable of viewing at least a portion of the lumen prior to deploying the implantable device when the side openings are aligned with each other. A mechanism is coupled to at least one of the inner and 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 proximal and distal ends, wherein the distal end of the outer tube comprises an opening and the implantable device is positioned proximate to the distal end of the outer tube, wherein the implantable device includes a distal end and a proximal end;

a longitudinal inner tube positioned within the outer tube and having proximal and distal ends, wherein the outer tube and the inner tube are axially displaceable with respect to one another, and wherein an outer diameter of the distal end of the inner tube is less than an inner diameter of the opening at the distal end of the outer tube;

a side opening defined in each of the inner and outer tubes, wherein each side opening is defined proximate to the implantable device and is capable of substantially aligning with the other side opening; and

a mechanism coupled to at least one of the inner and outer tubes and operable to axially displace the inner and outer tubes with respect to one another and to deploy the implantable device out of the opening at the distal end of the outer tube and within the lumen,

wherein both the inner tube and the outer tube comprise a coil formed longitudinally therein, the coil including proximal and distal ends, positioned within each of the inner and outer tubes having proximal and distal ends, wherein a respective side opening of each of the inner and outer tubes is defined distally of the distal end of each of the respective coils,

wherein each of the side openings aligns with each other proximate to the proximal end of the implantable device, and wherein the distal end of the outer tube extends distally of the distal end of the inner tube and proximate to the distal end of the implantable device when the side openings are aligned with one another.

2. The delivery device according to claim 1, further comprising an optical device positioned within the inner tube and proximate to each side opening such that the optical device is capable of viewing at least a portion of the lumen prior to deploying the implantable device when the side openings are aligned with each other.

3. The delivery device according to claim 1, wherein the side opening of the inner tube or outer tube including the coil is defined longitudinally between the coil and the implantable device.

4. The delivery device according to claim 3, wherein each of the inner and outer tubes comprises a polymeric material, and wherein each coil is formed within the polymeric material.

5. The delivery device according to claim 4, wherein the polymeric material comprises at least one of a polytetrafluoroethylene and a polyether block amide.

6. The delivery device according to claim 1, wherein each of the side openings comprises an oval having a major and a minor axis.

7. The delivery device according to claim 6, wherein the major axis of each of the side openings extends substantially parallel to a longitudinal axis of the respective inner and outer tubes.

8. The delivery device according to claim 1, wherein each of the side openings extends less than midway about a circumference of each of the inner and outer tubes.

9. The delivery device according to claim 2, wherein the optical device is capable of viewing, through the side openings, at least a proximal end of a target area within the lumen.

10. The delivery device according to claim 2, wherein the optical device is capable of extending through each of the side openings to view a target area within the lumen.

11. The delivery device according to claim 1, further comprising a pusher at the distal end of the inner tube, wherein the implantable device has proximal and distal ends, and wherein the pusher is configured to underlie the proximal end of the implantable device and the distal end of the outer tube extends distally of the pusher and is positioned proximate to the distal end of the implantable device.

12. The delivery device according to claim 11, wherein each of the side openings align with each other proximally of the pusher.

13. The delivery device according to claim 11, wherein the side opening of the inner tube is defined proximally of the pusher.

14. The delivery device according to claim 1, wherein the mechanism comprises at least one actuator coupled to the outer tube.

27. The device according to claim 1, wherein the mechanism is configured to retract the outer tube relative to the inner tube such that the distal end of the inner tube is adjacent to the opening at the distal end of the outer tube when the implantable device is deployed.

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

an implantable device having a proximal end and a distal end;

positioning the implantable device within an outer tube, wherein the outer tube has an open distal end;

sliding the outer tube over an inner tube to substantially align a pair of side openings defined in each of the inner and outer tubes;

positioning the inner and outer tubes within the lumen;

viewing at least a portion of the target area proximate to each of the side openings; and

deploying the implantable device out of the open distal end of the outer tube and proximate to the target area such that the implantable device expands as the inner and outer tubes are displaced with respect to one another;

wherein both the inner tube and the outer tube comprise a coil formed longitudinally therein, the coil including proximal and distal ends, positioned within each of the inner and outer tubes having proximal and distal ends, wherein a respective side opening of each of the inner and outer tubes is defined distally of the distal end of each of the respective coils,

wherein each of the side openings aligns with each other proximate to the proximal end of the implantable device, and wherein the distal end of the outer tube extends distally of the distal end of the inner tube and proximate to a distal end of the implantable device when the side openings are aligned with one another.

16. The method according to claim 15, wherein viewing comprises positioning an optical device within the inner tube and proximate to a proximal end of the target area.

17. The method according to claim 15, wherein sliding comprises sliding the outer tube such that the side opening of the outer tube aligns with the side opening of the inner tube proximally of a pusher positioned on a distal end of the inner tube.

18. The method according to claim 15, wherein deploying comprises retracting the outer tube proximally over the inner tube such that the distal end of the outer tube is moved from a position offset from a distal end of the inner tube prior to deploying the implantable device to a position substantially aligned with the distal end of the inner tube when the implantable device is fully deployed within the lumen.

29. The delivery device according to claim 15, wherein sliding comprises sliding the inner and outer tubes such that a coil formed within either the inner tube or the outer tube is located proximally of the side opening of the outer or inner tube, respectively.

30. The delivery device according to claim 29 wherein sliding comprises sliding the inner and outer tubes such that a coil formed within the inner tube is located proximally of the side opening of the outer tube and a coil formed within the outer tube is located proximally of the side opening of the inner tube.

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

an implantable device having proximal and distal ends;

a longitudinal outer tube having proximal and distal ends and a lumen extending therebetween, wherein the distal end of the outer tube is open and the implantable device is positioned within the lumen of the outer tube and proximate to the distal end of the outer tube;

a longitudinal inner tube positioned within the outer tube and having proximal and distal ends, wherein the outer tube and the inner tube are axially displaceable with respect to one another;

a side opening defined in each of the inner and outer tubes, wherein each side opening is defined proximate to the implantable device and is capable of substantially aligning with the other side opening prior to deploying the implantable device; and

a mechanism coupled to at least one of the inner and outer tubes and operable to axially displace the inner and outer tubes with respect to one another such that the implantable device is configured to expand out of the open distal end of the outer tube and within the lumen as the inner and outer tubes are axially displaced with respect to one another,

wherein both the inner tube and the outer tube comprise a coil formed longitudinally therein, the coil including proximal and distal ends, positioned within each of the inner and outer tubes having proximal and distal ends, wherein a respective side opening of each of the inner and outer tubes is defined distally of the distal end of each of the respective coils,

wherein each of the side openings aligns with each other proximate to the proximal end of the implantable device, and wherein the distal end of the outer tube extends distally of the distal end of the inner tube and proximate to a distal end of the implantable device when the side openings are aligned with one another.

20. The device according to claim 19, further comprising an optical device positioned within the inner tube and proximate to each side opening such that the optical device is capable of viewing at least a portion of the lumen when the side openings are aligned with each other.

21. The device according to claim 19, further comprising a pusher at the distal end of the inner tube, wherein the pusher is configured to underlie the proximal end of the implantable device and the distal end of the outer tube extends distally of the pusher and is positioned proximate to the distal end of the implantable device.

22. The delivery device according to claim 21, wherein each of the side openings align with each other proximally of the pusher.

23. The delivery device according to claim 21, wherein the side opening of the inner tubular member is defined proximally of the pusher.

24. The delivery device according to claim 21, wherein the side opening of the inner tube or the outer tube including the coil is defined longitudinally between the coil and the implantable device.

25. The device according to claim 19, wherein an outer diameter of the distal end of the inner tube is less than an inner diameter of the open distal end of the outer tube.

26. The device according to claim 19, wherein the implantable device comprises a self-expanding stent and is configured to lie adjacent to the lumen of the outer tube.

28. The delivery device according to claim 21, wherein the inner tube and the outer tube comprise a polymeric material, and wherein each coil is formed within the polymeric material.

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

a longitudinal outer tube having proximal and distal ends, wherein the implantable device is positioned within the outer tube, wherein the implantable device includes a proximal end and a distal end, and wherein the outer tube comprises a coil formed longitudinally therein;

a longitudinal inner tube positioned within the outer tube and having proximal and distal ends, wherein the outer tube and the inner tube are axially displaceable with respect to one another, and wherein the inner tube comprises a coil formed longitudinally therein;

a side opening defined in each of the inner and outer tubes, wherein each side opening is defined proximate to the proximal end of the implantable device and is capable of substantially aligning with the other side opening, and wherein each side opening is defined proximally of a respective coil formed in each of the inner and outer tubes; and

a mechanism coupled to at least one of the inner and outer tubes and operable to axially displace the inner and outer tubes with respect to one another to deploy the implantable device within the lumen.

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

a longitudinal outer tube having proximal and distal ends, wherein the implantable device, having a proximal end and a distal end, is positioned within the outer tube;

a longitudinal inner tube positioned within the outer tube and having proximal and distal ends, wherein the outer tube and the inner tube are axially displaceable with respect to one another;

a side opening defined in each of the inner and outer tubes, wherein each side opening is defined proximate to implantable device and is capable of substantially aligning with the other side opening, and wherein the distal end of the outer tube extends distally of the distal end of the inner tube a distance approximately equal to a length of the implantable device when the side openings are aligned with one another; and

a mechanism coupled to at least one of the inner and outer tubes and operable to axially displace the inner and outer tubes with respect to one another to deploy the implantable device within the lumen, and

wherein both the inner tube and the outer tube comprise a coil formed longitudinally therein, the coil including proximal and distal ends, positioned within each of the inner and outer tubes having proximal and distal ends, wherein a respective side opening of each of the inner and outer tubes is defined distally of the distal end of each of the respective coils,

wherein each of the side openings aligns with each other proximate to the proximal end of the implantable device, and wherein the distal end of the outer tube extends distally of the distal end of the inner tube and proximate to a distal end of the implantable device when the side openings are aligned with one another.