System and method for delivering a left atrial appendage containment device

• US 20050177182A1
• Filed: 12/03/2004
• Published: 08/11/2005
• Est. Priority Date: 12/04/2003
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Kume, Stewart M., van der Burg, Erik J.
• Application Number:
  US11/003,696
• Publication Number:
  US 20050177182A1
• Time in Patent Office: Days
• US Class Current: 606/157
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2230/008 : paraboloidal

Abstract

A method of delivering and deploying the device for containing the emboli during a surgical procedure proximate to the heart. Access is gained to the heart and the left atrium such that a distal end of the delivery sheath can be located near the left atrial appendage. A distal end of a delivery catheter can be loaded with the device in a collapsed position and passed through the delivery sheath thereby delivering the device within the left atrial appendage. The device is expanded to contain emboli in the left atrium appendage.

Claims

1. A method of delivering a device to a left atrial appendage comprising:

forming an opening in a chest of a patient suitable for surgical heart procedures;

advancing an implantable device through the opening and into a left atrium; and

passing the implantable device through the left atrium and positioning the implantable device at the left atrial appendage.

2. The method of claim 1, wherein the opening in the chest is formed by a sternotomy incision.

3. The method of claim 1, wherein the implantable device is positioned at the left atrial appendage as an adjunct to a surgical heart procedure.

4. The method of claim 3, wherein the surgical heart procedure comprises treatment of a valve of the heart.

5. The method of claim 4, wherein the treatment comprises one of repairing or replacing the valve of the heart.

6. The method of claim 1, wherein the implantable device is manually implanted by holding the device in a person'"'"'s hand, passing the device and a portion of the hand into the left atrium, and manually pushing the device into the left atrial appendage.

7. The method of claim 1, wherein the advancing of the device comprises:

passing a delivery sheath through the opening in the chest of a patient;

positioning a distal end of the delivery sheath proximate to the left atrial appendage;

advancing distally the device through the delivery sheath; and

delivering the device out of the distal end and into the left atrial appendage.

8. The method of claim 7, wherein the device is delivered out of the distal end of the delivery sheath when the distal end extends into the left atrial appendage.

9. The method of claim 7, further comprising distally advancing a push rod through the delivery sheath such that a distal end of the push rod pushes the device through the delivery sheath and out of the distal end of the delivery sheath.

10. A method of delivering a device to a left atrial appendage comprising:

forming an aperture in the outer wall of a left atrium of a heart;

advancing a delivery sheath through the aperture and into the left atrium;

positioning a distal end of the delivery sheath proximate to an orifice of the left atrial appendage while the delivery sheath extends through the left atrium and the aperture;

advancing a device through the delivery sheath and out of the distal end; and

implanting the device at the left atrial appendage.

11. The method of claim 10, wherein the device is delivered out of the distal end when the delivery sheath passes through the orifice and the distal end is positioned within the left atrial appendage.

12. The method of claim 10, further comprising:

positioning a transition catheter within the delivery sheath, the transition catheter extends distally from the distal end of the delivery sheath and forms a blunt tip;

advancing the delivery sheath and transition catheter and into the left atrium until the distal end of the delivery sheath is proximate to an orifice of a left atrial appendage; and

removing the transition catheter from the delivery sheath and then distally advancing the device through the delivery sheath.

13. The method of claim 10, wherein the delivery sheath has a curved distal portion shaped to direct the distal end of the delivery sheath towards the left atrial appendage.

14. A method of delivering a device to a left atrial appendage comprising:

providing a delivery sheath having a lumen and a distal end;

providing a transition catheter having a tip configured to reduce injury to a patient;

advancing the delivery sheath and transition catheter along the right atrium and through a transseptal hole and into the left atrium until a distal end of the delivery sheath is proximate to an orifice of a left atrial appendage;

removing the transition catheter from the delivery sheath;

distally advancing a device through the delivery sheath; and

implanting the device at the left atrial appendage while the distal end of the delivery sheath is disposed within the left atrial appendage.

15. The method of claim 14, wherein the device is distally advanced through the delivery sheath by distally moving a delivery catheter through the delivery sheath after the transition catheter has been removed from the delivery sheath.

16. The method of claim 15, wherein the device is implanted by operating the delivery catheter and expanding the device.

17. A method of delivering a device to a left atrial appendage comprising:

providing a left atrium access path through a pulmonary vein to a left atrial appendage;

advancing a delivery sheath along the left atrium access path until the delivery sheath is located proximate to the left atrial appendage;

advancing an implant through the delivery sheath until the implant passes out of a distal end of the delivery sheath; and

implanting the device at the left atrial appendage.

18. The method of claim 17, wherein the device is an expandable implant configured to prevent passage of embolic material from the left atrial appendage.

19. The method of claim 17, wherein the delivery sheath has a curved distal portion shaped to direct the distal end of the delivery sheath towards the left atrial appendage.

20. A system for delivering a device to the left atrial appendage, the system comprising:

an implant sized and configured to prevent passage of embolic material from a left atrial appendage;

a delivery sheath defining a lumen and a distal end;

a transition catheter having an atraumatic tip and configured to slide through the lumen of the delivery sheath, the transition catheter being adapted to extend from the distal end of the delivery sheath when the distal end is proximate to the left atrial appendage; and

a delivery catheter removably coupled to the implant, the delivery catheter and implant being configured to pass through the lumen of the delivery sheath to the left atrial appendage.

21. The system of claim 20, wherein the atraumatic tip is a soft blunt tip.

22. The system of claim 20, wherein the delivery sheath has a curved distal portion shaped to direct the distal end of the delivery sheath towards the left atrial appendage.

23. A system for delivering a device to the left atrial appendage, the system comprising:

an implant sized and configured to prevent passage of embolic material from a left atrial appendage; and

a delivery device configured to carry the implant to the left atrial appendage, the delivery device having a length configured to access the left atrial appendage through an opening in a chest of a patient, the delivery device having a length of about 80 cm or less.

24. The system of claim 23, wherein the delivery device is a delivery sheath having a lumen configured to receive the implant therein.

25. The system of claim 24, further comprising a delivery catheter configured to releasably engage the implant.

26. The system of claim 23, wherein the delivery sheath has a length that is greater than about 10 cm.

27. The system of claim 23, wherein the delivery device comprises a delivery catheter configured to releasably engage the implant.

28. The system of claim 27, wherein the delivery device further comprises a delivery sheath, the delivery catheter has length that is about 10 cm to about 30 cm greater than the length of the delivery sheath.

29. The system of claim 23, wherein the delivery device has a length of about 30 cm or less.

30. The system of claim 23, wherein the implant is configured to be positioned within the left atrial appendage.

31. The system of claim 23, wherein the implant is configured to be expanded within the left atrial appendage.

32. A system for delivering a device into the left atrial appendage, the system comprising:

an implant sized and configured to prevent passage of embolic material from a left atrial appendage;

a delivery device configured to carry the implant to the left atrial appendage, the delivery device having a length configured to access the left atrial appendage through an opening in a chest of a patient; and

means for providing surgical access to the left atrial appendage through the chest of the patient.

33. The system of claim 32, wherein the means for providing surgical access comprises at least one selected from the group consisting of a retractor, rib spreader, clamp, a trocar and a laparoscopic instrument.

34. The system of claim 32, wherein the means for providing surgical access to the left atrial appendage comprises surgical retractors.

35. The system of claim 32, wherein the means for providing surgical access to the left atrial appendage comprises a trocar.

36. The system of claim 32, wherein the means for providing surgical access to the left atrial appendage comprises means for providing access through the left atrium wall.

37. A system for delivering a device into the left atrial appendage of a patient, the system comprising:

an implant sized and configured to prevent passage of embolic material from a left atrial appendage;

a delivery device configured to carry the implant to the left atrial appendage, the delivery device having a length configured to access the left atrial appendage through an opening in a chest of a patient; and

means for performing a surgical heart procedure in the heart of the patient.

38. The system of claim 37, wherein the means for performing a surgical heart procedure comprises at least one selected from the group consisting of a retractor, rib spreader, forceps, and clamp.

39. The system of claim 37, wherein means for performing a surgical heart procedure comprises at least one selected from the group consisting of cauterizing instruments or substances, electrosurgical pen, suction apparatus, approximators, rongeur, clip applier, stapler, suture, needle holder, and bulldogs.

40. The system of claim 37, wherein the means for performing a surgical heart procedure comprises at least one selected from the group consisting of a sizing ring, balloon, caliper, and gage.

41. A system for delivering a device to the left atrial appendage of a patient, the system comprising:

an implant sized and configured to prevent passage of embolic material from a left atrial appendage; and

a delivery device configured to carry the implant to the left atrial appendage, the delivery device sized and configured to access the left atrial appendage through a pulmonary vein, the delivery device having a length of about 50 cm or less.

42. The system of claim 41, wherein the delivery sheath has a length in the range of about 15 cm to about 50 cm.

43. The system of claim 41, further comprising a delivery catheter, wherein the delivery catheter has length that is about 10 cm to about 30 cm greater than the length of the delivery device.

44. The system of claim 41, further comprising means for accessing the pulmonary vein through the chest of the patient.