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

• US 8,840,641 B2
• Filed: 01/08/2010
• Issued: 09/23/2014
• Est. Priority Date: 01/08/2009
• Status: Active Grant

• Current Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Original Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Inventors: Miles, Scott D., Edmiston, Daryl R.
• Primary Examiner(s): Tyson, Melanie
• Assistant Examiner(s): Scherbel, Todd J
• Application Number:
  US12/684,795
• Publication Number:
  US 20100228285A1
• Time in Patent Office: 1,719 Days
• Field of Search: None
• US Class Current: 606/213
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• 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 17/12031 complete occlusion
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• 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 2017/00526 Methods of manufacturing
• 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 2017/00588 Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 : Implements comprising a membrane
• CPC Class Codes: A61B 2017/00601 : Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/0061 : Implements located only on one side of the opening
• CPC Class Codes: A61B 2017/00632 : Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/00867 : shape memory effect
• CPC Class Codes: A61B 2017/00884 : enhancing wound closure
• CPC Class Codes: A61B 2017/0409 : Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0412 : having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 : having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0437 : the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0446 : Means for attaching and blocking the suture in the suture anchor
• CPC Class Codes: A61B 2017/0448 : Additional elements on or within the anchor
• CPC Class Codes: A61B 2017/0459 : Multiple holes in the anchor through which the suture extends and locking the suture when tension is applied
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/1205 : Introduction devices
• CPC Class Codes: Y10T 29/49826 : Assembling or joining

Abstract

Medical devices, systems and methods for modifying a left atrial appendage (“LAA”). In one embodiment, a medical device system includes a jailing member or structure positioned over the ostium of an LAA and at least one tissue growth member positioned within the LAA and retained within the LAA by the jailing member. In another embodiment, a medical device includes an atrial stent coupled with a patch that is configured to cover the ostium of an LAA. The patch may have a tissue growth member associated therewith. In another embodiment, the patch may include an open-cell frame which may be used as a jailing member or structure.

Claims

1. A method of modifying a left atrial appendage having an ostium defining an axis, the method comprising:

positioning a jailing member over the ostium of a left atrial appendage against a left atrium side wall such that the jailing member is sized larger than the ostium and outside of the left atrial appendage, the jailing member including a hub with multiple interconnected struts extending from the hub, the multiple interconnected struts defining a multi-cellular structure movable between a constricted position and an expanded position, the struts of the jailing member in the expanded position extending to define a flat structure such that the flat structure is positioned over the ostium with an orientation substantially perpendicular to the axis of the ostium;

anchoring the jailing member against the left atrium side wall and over the ostium with an anchoring portion extending from the jailing member to engage tissue inside of the left atrial appendage;

inserting a catheter through a cell defined between the struts of the multi-cellular structure and off-set from the hub of the jailing member and into the left atrial appendage;

disposing at least one tissue growth member within the left atrial appendage via the catheter, the at least one tissue growth member being separate and discrete from the jailing member; and

retaining the at least one tissue growth member within the left atrial appendage with the jailing member.

2. The method according to claim 1, further comprising providing a tensile bias between the anchoring portion and the jailing member.

3. The method according to claim 1, wherein the step of positioning a jailing member over the ostium of a left atrial appendage includes delivering the jailing member to the left atrial appendage with a first catheter, and wherein the step of inserting a catheter through a cell defined between the struts of the multi-cellular structure and off-set from the hub of the jailing member and the step of disposing at least one tissue growth member within the left atrial appendage includes inserting a second catheter through the opening within the jailing member and delivering the at least one tissue growth member with the second catheter.

4. The method according to claim 3, further comprising advancing the first catheter through a primary catheter to access the left atrial appendage, withdrawing the first catheter from the primary catheter subsequent delivering the jailing member to the left atrial appendage, and advancing the second catheter through the primary catheter subsequent withdrawing the first catheter.

5. The method according to claim 1, wherein the step of disposing at least one tissue growth member within the left atrial appendage further includes disposing a plurality of tissue growth elements within the left atrial appendage.

6. The method according to claim 5, further comprising connecting the plurality of tissue growth elements with a tether.

7. The method according to claim 1, wherein the step of anchoring comprises anchoring with the anchor portion extending from a proximate center of the jailing member.

8. The method according to claim 1, wherein the step of anchoring comprises anchoring the jailing member with the anchoring portion having nubs to atraumatically engage tissue in the left atrial appendage.

9. The method according to claim 1, wherein the step of anchoring comprises anchoring the jailing member with the anchoring portion extending from an intermediate anchoring portion oriented substantially perpendicular relative to the flat structure of the jailing member and the anchoring portion including multiple legs extending from the intermediate anchoring portion to engage tissue in the left atrial appendage.