Occluder device double securement system for delivery/recovery of such occluder device

• US 8,764,848 B2
• Filed: 09/26/2005
• Issued: 07/01/2014
• Est. Priority Date: 09/24/2004
• Status: Active Grant

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Inventors: Callaghan, David J., McLellan, Noel
• Primary Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US11/235,661
• Publication Number:
  US 20060122647A1
• Time in Patent Office: 3,200 Days
• Field of Search: 623 2372- 2374, 606/153, 606/157, 606/200, 606/213
• US Class Current: 623/23.72
• 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 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• 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 2017/00867 shape memory effect
• 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

Abstract

Devices, delivery systems and delivery techniques for an occlusion device for the closure of physical anomalies, such as an atrial septal defect, a patent foramen ovale (PFO), and other septal and vascular defects are described. The devices, delivery systems and delivery techniques relate particularly to, but are not limited to, a patent foramen ovale (PFO) occluder made from a polymer tube. Specifically, a petal-shaped occluder with a catch system is provided within a delivery sheath. In certain embodiments, the delivery system includes a first securement system for securing a first end of the occluder and a second securement system for securing a second end of the occluder to a delivery catheter and a delivery wire contained in the delivery system. The securement enable the deployment (and retrieval) of the device. The securement systems enable pushing and pulling of respective ends of the occluder to expand and contract the device by varying its axial length. In one aspect, the first securement system employs a threaded connection and the second securement system employs a suture connection. In another aspect, the first securement system employs a threaded connection and the second securement system employs a collet finger connection. The securement systems are detached when the device has been properly positioned. The securement systems can be manipulated by control systems provided in the control portion of the delivery system.

Claims

1. A medical apparatus including a collapsible for occluding an aperture in a body, the medical device having a first configuration as a reduced profile and a second configuration as an expanded profile, the medical device being adapted to be delivered into a desired delivery location through a delivery system comprising a delivery wire and a delivery catheter, the medical device comprising:

a proximal side and a distal side,

a first threaded portion directly coupling the proximal side of the device to a threaded portion of the delivery catheter of the delivery system, and a second threaded portion directly coupling the distal side of the device to a threaded portion of the delivery wire of the delivery system

wherein the relative cooperative movement of the first threaded portion and the second threaded portion changes the configuration of the device from the expanded profile configuration to the reduced profile, and wherein the first threaded portion and the second threaded portion are positioned on the proximal side of the device when the device is in the expanded profile configuration.

2. A medical apparatus including a medical device for occluding an aperture in a body and a delivery system comprising a delivery wire and a delivery catheter, the medical device having a first configuration as a reduced profile and a second configuration as an expanded profile, the medical device being adapted to be delivered through the delivery system into a desired delivery location, the medical device comprising:

a tube comprising a proximal side and a distal side,

a central portion disposed between the proximal side and the distal side of the tube, the central portion remaining disposed along a central axis of the device when an axial length of the tube is shortened, the proximal and distal sides comprising an arrangement of struts, whereby loops having a first and second end are formed from the struts by the axial shortening of the tube and each loop originates at a first end from the central portion of the tube;

a first attachment securing the device to the delivery system, the first attachment being disposed at a central axis of the device and including a threaded connection directly coupling the device to the delivery wire of the delivery system, and a second attachment securing the device to the delivery system, the second attachment including a threaded connection with male threads disposed on a surface of the device directly coupling the device to the delivery catheter of the delivery system

wherein the relative movement of the second attachment and the first attachment when the first attachment and second attachment are coupled to the delivery system shortens the axial length of the tube to change the configuration of the device from the reduced profile configuration to the expanded profile configuration so the loops extend radially from the central axis of the device, wherein both the first attachment and second attachments are releasable by unscrewing the threaded connection, and wherein the threaded connection of the first attachment and the threaded connection of the second attachment are positioned proximal to the arrangement of struts of the proximal side when the device is in the expanded profile.

3. The medical apparatus recited in claim 2, wherein threads associated with the first attachment are configured to be unscrewed with a different rotational direction than threads associated with the second attachment.

4. The medical apparatus recited in claim 2, wherein threads associated with the first attachment are configured to be unscrewed with the same rotational direction as threads associated with the second attachment.

5. The medical apparatus recited in claim 2, wherein the medical device is bioabsorbable.