Method of implanting a device in the left atrial appendage

• US 7,044,134 B2
• Filed: 10/19/2001
• Issued: 05/16/2006
• Est. Priority Date: 11/08/1999
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: EV3 Sunnyvale Incorporated
• Inventors: Kume, Stewart M., Frazier, Andrew G. C., Kreidler, Marc S., Khairkhahan, Alexander K., Roue, Chad C., Ogi, Darrell H., van der Burg, Erik J., Klenk, Alan R.
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US10/033,371
• Publication Number:
  US 20020111647A1
• Time in Patent Office: 1,670 Days
• Field of Search: 128/887, 128/898, 606190-200, 606/213, 606/1, 606/108, 606/159, 606/167, 606/151, 604 9601-109, 604508-510
• US Class Current: 128/887
• 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 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• 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 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/081 Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2230/008 : paraboloidal
• CPC Class Codes: A61M 2025/1054 : having detachable or disposable balloons
• CPC Class Codes: A61M 2210/125 : Heart
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

An adjustable occlusion device and a method of implanting the device in a body lumen such as the left atrial appendage. The occlusion device is removably carried by a deployment catheter. The device may be enlarged or reduced to facilitate optimal placement or removal. Methods are also disclosed.

Claims

1. A method of implanting a device in the left atrial appendage, comprising the steps of:

providing a deployment catheter, having an elongate flexible body with a proximal end and a distal end, a control on the proximal end and a device removably carried adjacent the distal end;

positioning at least a portion of the device in the left atrial appendage; and

manipulating the control to enlarge the device under positive force;

wherein the device comprises an expandable frame comprising at least two spokes, wherein the spokes are cut from a tube.

2. A method as in claim 1, wherein the manipulating step comprises rotating the control.

3. A method as in claim 1, wherein the frame comprises at least six spokes.

4. A method as in claim 3, wherein each spoke is movable from an axial orientation when the device is in a reduced cross section to an inclined orientation when the device is in an enlarged cross section.

5. A method as in claim 4, wherein each spoke comprises a proximal section, a distal section, and a bend in between the proximal and distal sections when the device is in the enlarged cross section.

6. A method as in claim 1, wherein the device further comprises a plurality of tissue anchors, and the method comprises the step of engaging tissue with at least some of the tissue anchors.

7. A method of implanting a device in the left atrial appendage, comprising:

providing a catheter having an elongate flexible body with a proximal end and a distal end, and an implantable device removably carried adjacent the distal end;

positioning at least a portion of the device in the left atrial appendage; and

enlarging the device within the left atrial appendage,

wherein the catheter comprises a deployment element extending therethrough releasably connected to the device.

8. The method of claim 7, wherein the deployment element comprises a flexible line.

9. The method of claim 7, wherein the deployment element comprises a core.

10. The method of claim 7, wherein the deployment element comprises a pull wire.

11. The method of claim 7, wherein the deployment element is controlled by proximal retraction of the deployment element.

12. The method of claim 7, wherein the elongate flexible body comprises a lumen through which the deployment elements is provided.

13. The method of claim 7, wherein enlarging the device within the left atrial appendage axially shortens the device.

14. The method of claim 7, wherein the device comprises a proximal hub and a distal hub.

15. The method of claim 14, wherein enlarging the device within the left atrial appendage comprises proximally retracting the distal hub while resisting movement of the proximal hub.

16. The method of claim 7, wherein the device self-expands to its enlarged shape.

17. The method of claim 7, further comprising releasing the device after the device is enlarged within the left atrial appendage.

18. A method for implanting a device in the left atrial appendage of a patient, comprising:

providing an implantable device having a proximal end and a distal end, the implantable device having a collapsed configuration and an expanded configuration;

positioning the implantable device in the left atrial appendage while the device is in its collapsed configuration; and

expanding the implantable device in the left atrial appendage, wherein the device is enlarged by providing relative movement between a proximal end and a distal end of the device.

19. The method of claim 18, wherein expanding the implantable device comprises drawing the proximal and distal ends of the device relatively closer together.

20. The method of claim 18, wherein expansion of the device is at least partially controlled by a deployment line connected to one of the ends of the implantable device and extending through a deployment catheter.

21. The method of claim 20, wherein the deployment line is releasably connected to a proximal end of the implantable device.

22. The method of claim 20, wherein the deployment line is releasably connected to a distal end of the implantable device.

23. The method of claim 18, further comprising an inner member extending through a deployment catheter and extending to the distal end of the implantable device.

24. The method of claim 18, wherein the implantable device is at least partially self-expanding.

25. A method for implanting a device in the left atrial appendage of a patient, comprising:

providing an implantable device having a proximal end and a distal end, the implantable device having a collapsed configuration and an expanded configuration;

positioning the implantable device in the left atrial appendage while the device is in its collapsed configuration; and

expanding the implantable device in the left atrial appendage, wherein the device is enlarged by providing relative movement between a proximal end and a distal end of the device;

wherein a core extends through a deployment catheter and extends to the distal end of the implantable device, and wherein relative movement between the proximal and distal ends of the implantable device is provided by moving the core in a proximal direction.

26. A method for implanting a device in the left atrial appendage of a patient, comprising:

providing an implantable device having a proximal end and a distal end, the implantable device having a collapsed configuration and an expanded configuration;

positioning the implantable device in the left atrial appendage while the device is in its collapsed configuration; and

expanding the implantable device in the left atrial appendage, wherein the device is enlarged by providing relative movement between a proximal end and a distal end of the device;

wherein a core extends through a deployment catheter and extends to the distal end of the implantable device, and wherein the implantable device is maintained in its collapsed configuration while being positioned in the left atrial appendage by holding stationary one end of the device while moving the other end of the device.

27. A method for implanting a device in the left atrial appendage of a patient, comprising:

providing an implantable device having a proximal end and a distal end, the implantable device having a collapsed configuration and an expanded configuration;

positioning the implantable device in the left atrial appendage while the device is in its collapsed configuration, the implantable device when delivered into the left atrial appendage being releasably connected to a deployment line extending outside of the patient; and

expanding the implantable device in the left atrial appendage;

wherein the deployment line is releasably connected to and looped around a portion of the implantable device.

28. The method of claim 27, wherein the implantable device is delivered to the left atrial appendage using a catheter.

29. A method for implanting a device in the left atrial appendage of a patient, comprising:

providing an implantable device having a proximal end and a distal end, the implantable device having a collapsed configuration and an expanded configuration;

positioning the implantable device in the left atrial appendage while the device is in its collapsed configuration, the implantable device when delivered into the left atrial appendage being releasably connected to a deployment line extending outside of the patient;

expanding the implantable device in the left atrial appendage; and

releasing the deployment line from the implantable device after the implantable device is appropriately expanded in the left atrial appendage;

wherein the deployment line is releasably connected to a proximal end of the implantable device, wherein the deployment line is a pull wire boned around a pin at the proximal end of the implantable device, and wherein the pull wire is looped over the pin and around a core extending through the implantable device.

30. A method for delivering an implantable device within a left atrial appendage of a patient, comprising:

providing a deployment catheter having a proximal end and a distal end, the deployment catheter having an elongate core and a pull wire extending therethrough;

delivering an implantable device having a proximal end and a distal end to the left atrial appendage using the deployment catheter, the implantable device having a collapsed configuration wherein the proximal and distal ends are relatively far apart and an expanded configuration wherein the proximal and distal ends are relatively close together, the proximal end releasably connected to the pull wire and the distal end engaged with the elongate core, wherein the pull wire is held taut and the elongate core is pushed against a distal surface of the implantable device to hold the implantable device in its collapsed configuration during delivery; and

expanding the implantable device within the left atrial appendage by moving the elongate core proximally relative to the proximal end of the device and the pull wire, the proximal movement causing the implantable device to expand under its own bias to the expandable configuration.

31. The method of claim 30, further comprising at least partially collapsing the implantable device after expanding the implantable device to reposition the implantable device by moving the elongate core relatively distally against the distal surface and moving the pull wire relatively proximally causing the proximal and distal ends of the implantable device to move relatively apart.

32. The method of claim 30, wherein the elongate core slides relative to the implantable device within a guide tube extending axially within the implantable device.

33. The method of claim 30, further comprising removing the elongate core and the pull wire from the implantable device after confirming the position of the implantable device within the left atrial appendage.

34. The method of claim 30, wherein the pull wire is releasably locked to the implantable device by looping the pull wire around a pin at the proximal end of the device and around the core.

35. The method of claim 30, wherein the core is threadingly engageable with a portion of the implantable device.

36. The method of claim 30, wherein the elongate core provides a distal retention force against the distal end of the implantable device, and wherein expanding the implantable device within the left atrial appendage by moving the elongate core proximally relative to the proximal end of the device and the pull wire comprises manipulating the pull wire while maintaining the distal retention force such that the implantable device expands under its own bias, drawing the proximal end of the device toward the distal end.

37. A method for implanting a device in the left atrial appendage of a patient, comprising:

providing an implantable device having a proximal end and a distal end, the implantable device having a collapsed configuration and an expanded configuration;

positioning the implantable device in the left atrial appendage while the device is in its collapsed configuration, the implantable device when delivered into the left atrial appendage being releasably connected to a deployment line extending outside of the patient; and

expanding the implantable device in the left atrial appendage.

38. The method of claim 37, wherein the deployment line is releasably connected to a proximal end of the implantable device.

39. The method of claim 37, wherein the implantable device is delivered to the left atrial appendage using a catheter.