Medical device for modification of left atrial appendage and related systems and methods

• US 9,649,115 B2
• Filed: 06/18/2014
• Issued: 05/16/2017
• Est. Priority Date: 06/17/2009
• Status: Active Grant

• Current Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Original Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Inventors: Davis, Clark C., Miles, Scott D., Edmiston, Daryl R., Martin, John Alexander
• Primary Examiner(s): LOUIS, RICHARD G
• Application Number:
  US14/308,695
• Publication Number:
  US 20140364941A1
• Time in Patent Office: 1,063 Days
• 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 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/0069 with universal joint, cardan joint
• CPC Class Codes: A61B 2017/1205 Introduction devices
• 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 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2002/016 made from wire-like elements

Abstract

Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a medical device coupled to a delivery catheter includes a fluid flow path that facilitates contrast fluid to pass through the delivery catheter and the medical device to a distal side thereof to provide imaging information as to the position of the medical device positioned in the opening, such as the left atrial appendage. In another embodiment, a medical device is coupled to a delivery catheter, the medical device including flaps adjacent a hub of the medical device that close-off a bore of the hub upon the catheter being detached from the medical device.

Claims

1. A method for modifying a left atrial appendage (“

LAA”

) of a heart, the method comprising;

positioning a medical device coupled to a distal end of a delivery catheter within the LAA of the heart such that the medical device includes an occluder portion having a substantially non-permeable material that substantially blocks fluid from exiting the LAA;

injecting contrast fluid through the delivery catheter and through a hub of the medical device and into the LAA;

viewing the contrast fluid injected into the LAA with an imaging device; and

determining whether the medical device is properly positioned in the LAA upon viewing the contrast fluid in the LAA with the non-permeable material of the medical device substantially maintaining the contrast fluid in the LAA;

wherein the positioning the medical device comprises deploying the occluder portion of the medical device and, then, upon the occluder portion being in an expanded, deployed position, actuating an anchor portion of the medical device from a retracted position to an anchor deployed position.

2. The method according to claim 1, further comprising advancing the medical device through a sheath in the vasculature and to the LAA of the heart.

3. The method according to claim 1, wherein the injecting comprises injecting the contrast fluid through a fluid port in a handle coupled to a proximal end of the delivery catheter such that the contrast fluid flows through a lumen defined within and along a longitudinal length of the delivery catheter.

4. The method according to claim 1, wherein the positioning comprises engaging the anchor portion of the medical device to tissue in the LAA.

5. The method according to claim 1, wherein the injecting contrast fluid comprises injecting contrast fluid with an injection member.

6. The method according to claim 1, wherein the injecting comprises injecting the fluid along a flow path that is defined at least through the hub of the medical device such that the contrast fluid exits a distal side of the hub of the medical device and into the LAA.

7. The method according to claim 1, wherein the determining comprises determining whether there are gaps between an outer periphery of the medical device and the tissue of the LAA by viewing the contrast fluid.

8. The method according to claim 1, further comprising re-positioning the medical device in the LAA upon determining contrast fluid is not being substantially maintained within the LAA with the medical device.

9. The method according to claim 1, wherein the positioning the medical device comprises actuating the anchor portion of the medical device between the retracted position and the anchor deployed position such that a portion of the anchor portion is moveable through the hub of the medical device.

10. The method according to claim 9, wherein the actuating the anchor portion comprises pivoting the anchor portion at a hinged coupling between the anchor portion and the occluder portion.

11. The method according to claim 9, wherein the actuating the anchor portion comprises actuating actuator arms of the anchor portion substantially along an axis of the medical device.

12. The method according to claim 1, wherein the positioning the medical device comprises substantially occluding the LAA such that the non-permeable material of the occluder portion comprises ePTFE.