Methods and Devices for Occlusion of an Atrial Appendage

• US 20100145361A1
• Filed: 10/02/2009
• Published: 06/10/2010
• Est. Priority Date: 06/18/2004
• Status: Active Grant

• Current Assignee: Andrew L. Olson, Christopher J Plott, Christopher W. Smith, Daniel C. Haeg, David Francischelli, Douglas H. Gubbin, Jessica L. Foley, Joseph E. Cardinal, Kim David, Leonard H. Leuer, Mark T. Stewart, Michael J. Hobday, Patrick J. Cloutier, Paul T. Rothstein, Roderick E. Briscoe, Tessy Kanayinkal, Tom P. Daigle
• Original Assignee: Andrew L. Olson, Christopher J Plott, Christopher W. Smith, Daniel C. Haeg, David Francischelli, Douglas H. Gubbin, Jessica L. Foley, Joseph E. Cardinal, Kim David, Leonard H. Leuer, Mark T. Stewart, Michael J. Hobday, Patrick J. Cloutier, Paul T. Rothstein, Roderick E. Briscoe, Tessy Kanayinkal, Tom P. Daigle
• Inventors: Kim, David, Foley, Jessica L., Cardinal, Joseph E., Leuer, Leonard H., Haeg, Daniel C., Kanayinkal, Tessy, Smith, Christopher W., Rothstein, Paul T., Briscoe, Roderick E., Daigle, Tom P., Francischelli, David E., Plott, Christopher J., Gubbin, Douglas H., Olson, Andrew L., Stewart, Mark T., Hobday, Michael J., Cloutier, Patrick J.
• Granted Patent: US 8,926,635 B2
• Time in Patent Office: Days
• US Class Current: 606/139
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/12018 Elastic band ligators

Abstract

A novel occluder application and clip device for treatment of embolic stroke caused by atrial fibrillation uses multiple sutures in a non directional handle to affix the occlusion device to the applicator and manipulate the occluder from an open and receiving position to a closed and occluding position. The occluder is retained in place by a clamping means related to locks retainers, resilient material or otherwise. An actuator mechanism is used to manipulate the occluder to a locked or occluding position. The applicator with the occluder attached has a low profile and remote manipulations to allow the occluder to be delivered to the clamping location within a patient through a small incision or delivery port such as a trocar cannula or the like.

Claims

1. A system for occluding a left atrial appendage of a patient, the system comprising:

a ring occluder that can be positioned around the left atrial appendage; and

a ring applicator to position the ring occluder with respect to the left atrial appendage,

the ring applicator including a ring spreader with a spreader hinge coupled to an upper spreader jaw and a lower spreader jaw,

the ring occluder coupled between the lower spreader jaw and the upper spreader jaw,

the spreader hinge moving between an open position in which the ring occluder has a first diameter and a closed position in which the ring occluder has a second diameter, the first diameter being larger than the second diameter.

2. The system of claim 1 wherein the ring occluder includes at least one of micro-sized glass beads, glass fibers, and metallic fibers.

3. The system of claim 1 wherein the ring occluder includes a biocompatible, elastomeric material.

4. The system of claim 1 wherein the ring occluder is covered by a material to promote tissue ingrowth and prevent slippage.

5. The system of claim 1 wherein the spreader hinge includes a four-bar assembly.

6. The system of claim 1 wherein the ring applicator includes a jaw actuator that controls the spreader hinge.

7. The system of claim 1 wherein the ring applicator includes a lumen for insertion of a retraction mechanism.

8. The system of claim 1 wherein the ring applicator includes a lumen for insertion of a viewing device.

9. The system of claim 6 wherein the jaw actuator includes a knob and a torque screw.

10. The system of claim 6 wherein the jaw actuator includes a handle and a trigger mechanism.

11. The system of claim 6 wherein at least one suture is coupled to the jaw actuator, the spreader hinge, and the ring occluder.

12. The system of claim 1 wherein the ring applicator includes a plurality of slots and a plurality of apertures through which a plurality of sutures are positioned.

13. A system for occluding a left atrial appendage of a patient, the system comprising:

a clip occluder that can be positioned around the left atrial appendage, the clip occluder including a clip hinge coupled to an upper clip jaw and a lower clip jaw, the clip occluder including a clip lock; and

a clip applicator to position the clip occluder with respect to the left atrial appendage,

the clip applicator including a clip actuator coupled to the clip occluder by an actuator suture, the actuator suture controlling a distance between the upper clip jaw and the lower clip jaw,

the clip applicator removably coupled to the clip occluder with a retention suture.

14. The system of claim 13 wherein the clip applicator includes a clip stop and at least two alignment pins that engage the clip occluder.

15. The system of claim 13 wherein at least one of the actuator suture and the retention suture is cut and removed from the patient.

16. The system of claim 13 wherein the clip applicator includes a clip actuator including at least one of a torque screw assembly, a thumb slide, and a lever.

17. A clamp for occluding a left atrial appendage of a patient, the system comprising:

an upper pressure plate;

a lower pressure plate;

at least one connector rod coupled to the upper pressure plate and the lower pressure plate, the at least one connector rod include a plurality of teeth; and

at least one receiver coupled the at least one connector rod in order to engage the plurality of teeth, the at least one receiver being moveable to reduce a distance between the upper pressure plate and the lower pressure plate.

18. The clamp of claim 17 wherein the at least one connector rod is constructed of a material that can be clipped off after the at least one receiver is positioned.

19. The clamp of claim 17 wherein the at least one receiver bears against the upper pressure plate to move the upper pressure plate toward the lower pressure plate.

20. A clamp for occluding a left atrial appendage of a patient, the system comprising:

an upper pressure plate having a first tie channel;

a lower pressure plate having a second tie channel; and

a tie positioned through the first tie channel and the second tie channel, the tie being moveable to reduce a distance between the upper pressure plate and the lower pressure plate.

21. A system for occluding a left atrial appendage of a patient, the system comprising:

a loop clip occluder that can be positioned around the left atrial appendage, the loop clip occluder including a clip jaw, a loop, and a clip lock; and

a loop clip applicator to position the loop clip occluder with respect to the left atrial appendage,

the loop clip applicator including a loop clip actuator coupled to the loop clip occluder by an actuator suture, the actuator suture controlling movement of the loop with respect to the clip jaw and the clip lock,

the loop clip applicator removably coupled to the loop clip occluder with a retention suture.

22. The system of claim 21 wherein at least one of the actuator suture and the retention suture is cut and removed from the patient.

23. The system of claim 21 wherein the loop clip applicator includes a loop clip actuator including at least one of a torque screw assembly, a thumb slide.

24. The system of claim 21 wherein the loop includes a plurality of teeth to engage the clip lock.

25. The system of claim 21 wherein the loop includes a fixed end rigidly coupled to a first end of the clip jaw and a slidable end coupled to a second end of the clip jaw.

26. A system for occluding a left atrial appendage of a patient, the system comprising:

a ring applicator including

a shaft having a handle on a proximal end and a distal end, and a lumen extending from the handle to the distal end of the shaft,

an actuator coupled to the handle, and

a ring spreader assembly on the distal end of the shaft, the ring spreader assembly having a plurality of ring expanding members; and

a ring occluder releasably attached to the plurality of ring expanding members, the ring occluder being stretched to an open position by the actuator to allow the ring occluder to be manipulated over tissue to be occluded.

27. The system of claim 26 wherein the ring occluder includes silicone rubber.

28. The system of claim 26 wherein the ring occluder is covered with a textile material.

29. The system of claim 26 wherein the actuator controls a position of the plurality of ring expanding members.

30. The system of claim 26 wherein the actuator includes a knob and a torque screw.

31. The system of claim 26 wherein the actuator includes a handle and a trigger mechanism.

32. The system of claim 26 wherein at least one suture is coupled to the actuator, at least one of the plurality of ring expanding members, and the ring occluder.

33. The system of claim 26 wherein the ring applicator includes a tissue-grasping member to move a portion of the left atrial appendage and with respect to the ring occluder.

34. The system of claim 33 wherein the tissue-grasping member includes at least one of a hook, a barb, a grasper, an adhesive, and a suction device.

35. The system of claim 33 wherein the tissue-grasping member moves between a distal position and a proximal position with respect to a shaft of the ring applicator.

36. The system of claim 26 wherein the ring occluder includes at least one of micro-sized glass beads, glass fibers, and metallic fibers.

37. The system of claim 26 wherein the ring occluder includes a biocompatible, elastomeric material.