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

• US 9,572,584 B2
• Filed: 03/17/2014
• Issued: 02/21/2017
• 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., Whisenant, Brian K., Edmiston, Daryl R., Davis, Clark C.
• Primary Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US14/215,266
• Publication Number:
  US 20140277117A1
• Time in Patent Office: 1,072 Days
• US Class Current: 1/1
• 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 for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00884 : enhancing wound closure
• CPC Class Codes: A61B 2017/0409 : Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• 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 lateral eyelet for attaching suture to needle A61B2017/06019
• 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

A medical device, system and method for modifying a left atrial appendage (“LAA”). The medical device system includes a tether anchored within the LAA and one or more tissue growth members or occluders configured to be slid over the tether and lodged within the LAA. With this arrangement, a physician may close-off the LAA with a selective number of tissue growth members to meet the varying LAA sizes as determined from imaging information while conducting the procedure.

Claims

1. A method for modifying a left atrial appendage, comprising:

positioning a catheter adjacent the left atrial appendage;

pushing a medical device having tines through a lumen of the catheter;

anchoring the medical device within the left atrial appendage;

deploying a tissue growth member of the medical device by exposing the tissue growth member from the catheter so that, as the tissue growth member is exposed, the tissue growth member self-expands to a deployed position, the medical device including threads being directly rotatably coupled to a threaded pusher member; and

maintaining the tissue growth member in the left atrial appendage with a locking element, the locking element including multiple fingers that collapse directly dependent upon proximally moving the threaded pusher member relative to the tissue growth member.

2. The method according to claim 1, wherein anchoring the medical device further comprises anchoring the medical device with a tether coupled thereto.

3. The method according to claim 2, further comprising disengaging the threaded pusher member from the medical device.

4. The method according to claim 3, wherein the disengaging comprises cutting the tether with a cutting element.

5. The method according to claim 3, wherein the disengaging comprises collapsing the multiple fingers of the locking element over the tether by proximally moving the threaded pusher member.

6. The method according to claim 1, wherein the deploying the tissue growth member comprises pushing the tissue growth member over a tether coupled to the medical device.

7. The method according to claim 6, wherein pushing the tissue growth member over the tether further comprises positioning the catheter within the left atrial appendage and deploying the tissue growth member from the catheter while slidably coupled with the tether.

8. The method according to claim 1, wherein the deploying the tissue growth member further comprises deploying the tissue growth member having self-expanding frame members coupled to a polymeric element.

9. The method according to claim 1, wherein the maintaining comprises disengaging the threaded pusher member from the medical device.

10. The method according to claim 1, wherein the deploying comprises maintaining the multiple fingers of the locking element in a non-collapsed position with a distal portion of the threaded pusher member engaged with a hub of the medical device.

11. A method for modifying a left atrial appendage, comprising:

positioning a sheath adjacent the left atrial appendage;

pushing a medical device having tines through a lumen of the sheath;

anchoring the medical device to the left atrial appendage with the tines;

deploying a tissue growth member of the medical device by exposing the tissue growth member from the catheter so that, as the tissue growth member is exposed, the tissue growth member self-expands to a deployed position; and

disengaging a threaded pusher member from threads of the medical device upon collapsing multiple fingers of a locking element directly dependent upon proximally displacing the threaded pusher member relative to the tissue growth member.

12. The method according to claim 11, wherein the disengaging comprises cutting a tether with a cutting element.

13. The method according to claim 12, wherein the disengaging comprises collapsing the multiple fingers of the locking element over the tether.

14. The method according to claim 11, wherein anchoring the medical device further comprises anchoring the medical device with a tether coupled thereto.

15. The method according to claim 11, wherein the deploying comprises maintaining the multiple fingers of the locking element in a non-collapsed position with a distal portion of the threaded pusher member.

16. The method according to claim 11, wherein the deploying the tissue growth member further comprises deploying the tissue growth member having self-expanding frame segments coupled to a polymeric element.