HANDLE ASSEMBLY FOR A LEFT ATRIAL APPENDAGE OCCLUSION DEVICE

• US 20130116724A1
• Filed: 11/07/2012
• Published: 05/09/2013
• Est. Priority Date: 11/08/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Clark, Christopher, Tischler, Brian, McPhail, Mark
• Granted Patent: US 9,474,516 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/0053 Loading magazines or sutures into applying tools
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts

Abstract

The disclosure pertains to a handle assembly for a left atrial appendage occlusion device delivery system and methods of use therefor. The handle assembly includes a leadscrew mechanism for smooth, low backlash control of a delivery catheter for the left atrial appendage occlusion device and manipulation segments which allow one hand operation of the handle assembly.

Claims

1. A handle assembly for a left atrial appendage occlusion device delivery system comprising:

a first non-rotating catheter displacement component rotatably connected to a second rotatable catheter displacement component, said a first non-rotating catheter displacement component having a distal end adapted to operably connect to a delivery catheter for a left atrial appendage occlusion device,

wherein the first non-rotating catheter displacement component and the second rotatable catheter displacement component further comprise a lumen therethrough,

further wherein the second rotatable catheter displacement component portion of the lumen comprises an internally threaded segment;

a first manipulation segment having a externally threaded tubular distal extension adapted to rotationally engage the internally threaded segment of the second rotatable catheter displacement component, said externally threaded tubular distal extension having a length; and

a second manipulation segment reversibly coupled to the first manipulation segment,

wherein the second manipulation segment has affixed thereto an elongate shaft adapted to slidably and rotatably pass through a lumen associated with the first manipulation segment, the lumen of the first non-rotating catheter displacement component and second rotatable catheter displacement component, and a connected delivery catheter for a left atrial appendage occlusion device,

further wherein rotation of the second rotatable catheter displacement component relative to the first non-rotating catheter displacement component is adapted to displace the delivery catheter proximally relative to the elongate shaft by a distance at least equal to the length of the externally threaded tubular distal extension of the first manipulation segment.

2. The handle assembly of claim 1, wherein the lumen of the first non-rotating catheter displacement component and second rotatable catheter displacement component is sized and adapted to slidably receive the externally threaded tubular distal extension of the first manipulation segment in a region distal of the internally threaded segment of the second rotatable catheter displacement component.

3. The handle assembly of claim 2, wherein the first manipulation segment having an externally threaded tubular distal extension further comprises a tubular segment affixed to a proximal end of the externally threaded tubular distal extension, said tubular segment being sized and adapted to be slidably received within the internally threaded segment of the second rotatable catheter displacement component.

4. The handle assembly of claim 3, wherein the lumen of the first non-rotating catheter displacement component and second rotatable catheter displacement component is sized and adapted to slidably receive the externally threaded tubular distal extension of the first manipulation segment and at least a portion of the tubular segment of the first manipulation segment in a region distal of the internally threaded segment of the second rotatable catheter displacement component.

5. The handle assembly of any of claims 2, wherein the distal end of the lumen of the first non-rotating catheter displacement component and second rotatable catheter displacement component is sized and adapted to prevent a distal end of the externally threaded tubular distal extension of the first manipulation segment from extending distally beyond the distal end of the first non-rotating catheter displacement component.

6. The handle assembly of any of claims 2, wherein the distal end of the externally threaded tubular distal extension of the first manipulation segment is sized and adapted to prevent the distal end of the externally threaded tubular distal extension from passing proximally through the internally threaded segment of the second rotatable catheter displacement component.

7. The handle assembly of claim 1, wherein the second manipulation segment is reversibly coupled to the first manipulation segment by a removable link.

8. The handle assembly of claim 1, wherein the second manipulation segment is reversibly coupled to the first manipulation segment by bayonet connection.

9. The handle assembly of claim 1, further comprising a hemostasis valve adapted to be disposed between the delivery catheter for a left atrial appendage occlusion device and the first non-rotating catheter displacement component.

10. The handle assembly of claim 9, further comprising a tubular seal displacing element adapted to be interposed between a seal of the hemostasis valve and the elongate shaft, wherein the tubular seal displacing element has a lumen sized and adapted to allow the elongate shaft to slidably and rotatably pass therethrough while substantially preventing fluid from passing through the lumen.

11. The handle assembly of claim 1, wherein the distal end of the elongate shaft is adapted to releasably connect to a left atrial appendage occlusion device.

12. The handle assembly of claim 1, wherein the delivery catheter for a left atrial appendage occlusion device includes at the distal end thereof a region adapted to contain a left atrial appendage occlusion device in a partially collapsed delivery configuration.

13. The handle assembly of claim 12, wherein the length of the externally threaded tubular distal extension of the first manipulation segment is at least equal to the length of a left atrial appendage occlusion device.

14. The handle assembly of claim 1, wherein the first non-rotating catheter displacement component and the externally threaded tubular distal extension of the first manipulation segment cooperate to prevent rotation of the externally threaded tubular distal extension of the first manipulation segment relative to the first non-rotating catheter displacement component.

15. A method of using a handle assembly for a left atrial appendage occlusion device delivery system comprising:

connecting a handle assembly for a left atrial appendage occlusion device delivery system comprising;

a first non-rotating catheter displacement component having a distal end adapted to operably connect to a delivery catheter for a left atrial appendage occlusion device;

a second rotatable catheter displacement component;

a first manipulation segment having an externally threaded tubular distal extension; and

a second manipulation segment having affixed thereto an elongate shaft adapted to slidably and rotatably pass through a lumen associated with the first manipulation segment, a lumen to the first non-rotating catheter displacement component and second rotatable catheter displacement component, and a connected delivery catheter for a left atrial appendage occlusion device, to a delivery catheter for a left atrial appendage occlusion device at the distal end of the first non-rotating catheter displacement component of the handle assembly;

positioning the distal end of the externally threaded tubular distal extension of the first manipulation segment proximate the distal end of the first non-rotating catheter displacement component such that a distal end of the elongate shaft extends beyond a distal end of the delivery catheter for a left atrial appendage occlusion device;

reversibly attaching a left atrial appendage occlusion device to the distal end of the elongate shaft;

withdrawing the left atrial appendage occlusion device into a distal end region of the delivery catheter for a left atrial appendage occlusion device adapted to contain a left atrial appendage occlusion device by moving the externally threaded tubular distal extension of the first manipulation segment proximally relative to the first non-rotating catheter displacement component and rotating the second rotatable catheter displacement component relative to the first non-rotating catheter displacement component.

16. The method of claim 15, wherein the connecting step includes deploying a hemostatic valve between the delivery catheter for a left atrial appendage occlusion device and the first non-rotating catheter displacement component.

17. A method of using a handle assembly for a left atrial appendage occlusion device delivery system comprising:

inserting a delivery catheter for a left atrial appendage occlusion device intravascularly into a patient,

wherein the delivery catheter has operably attached to its proximal end a handle assembly for a left atrial appendage occlusion device delivery system comprising;

a first non-rotating catheter displacement component having a distal end adapted to operably connect to a delivery catheter for a left atrial appendage occlusion device;

a second rotatable catheter displacement component;

a first manipulation segment having an externally threaded tubular distal extension; and

a second manipulation segment having affixed thereto an elongate shaft adapted to slidably and rotatably pass through a lumen associated with the first manipulation segment, a lumen to the first non-rotating catheter displacement component and second rotatable catheter displacement component,

wherein the delivery catheter for a left atrial appendage occlusion device further includes a collapsed left atrial appendage occlusion device disposed within a distal end region thereof,

further wherein the left atrial appendage occlusion device is releasably connected to the elongate shaft;

advancing the delivery catheter for a left atrial appendage occlusion device intravascularly until the left atrial appendage occlusion device is positioned at least partially within a left atrial appendage;

rotating the second rotatable catheter displacement component relative to the first non-rotating catheter displacement component to withdraw the distal end region of the delivery catheter for a left atrial appendage occlusion device from left atrial appendage occlusion device thereby deploying the left atrial appendage occlusion device within the left atrial appendage;

uncoupling the second manipulation segment reversibly coupled to the first manipulation segment from the first manipulation segment;

manipulating the second manipulation segment to detach the left atrial appendage occlusion device from the distal end of the elongate shaft; and

removing the delivery catheter for a left atrial appendage occlusion device from the patient.

18. The method of claim 17, wherein the handle assembly for a left atrial appendage occlusion device delivery system further includes a hemostasis valve deployed between the delivery catheter for a left atrial appendage occlusion device and the first non-rotating catheter displacement component.

19. The method of claim 18, further comprising advancing a tubular seal displacing element adapted to be interposed between a seal of the hemostasis valve and the elongate shaft to a position within the seal of the hemostasis valve.

20. The method of claim 18, further comprising withdrawing a tubular seal displacing element adapted to be interposed between a seal of the hemostasis valve and the elongate shaft from the seal of the hemostasis valve.