Sealing devices and related delivery apparatuses

• US 9,775,591 B2
• Filed: 11/20/2014
• Issued: 10/03/2017
• Est. Priority Date: 11/21/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Delgado, Sergio, Schneider, Ralph, Rowe, Stanton J., Wu, Ming H., Jafari, Mohammad, Boomgarden, Jon
• Primary Examiner(s): Templeton, Christopher L
• Application Number:
  US14/549,444
• Publication Number:
  US 20150142049A1
• Time in Patent Office: 1,048 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 17/0401 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 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/3209 Incision instruments
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• 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 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• 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 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/00867 : shape memory effect
• CPC Class Codes: A61B 2017/00986 : Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/0414 : having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0427 : having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/0641 : having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0645 : being elastically deformed for insertion
• CPC Class Codes: A61B 2017/3425 : for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/3458 : threaded
• CPC Class Codes: A61B 2017/346 : with wings
• CPC Class Codes: A61B 2017/3464 : with means acting on inner surface of valve or seal for expanding or protecting, e.g. inner pivoting fingers

Abstract

Embodiments of the present disclosure are directed to implantable sealing devices, delivery apparatuses, and methods of their use, for closing surgical openings or defects in a sidewall of a vessel in a subject. In several embodiments, the disclosed implantable sealing devices, delivery apparatuses, and methods can be used to close a surgical opening in a sidewall of the heart.

Claims

1. An implantable sealing device delivery assembly for closing an aperture in a vessel sidewall in a medical patient, the assembly comprising:

an implantable sealing device, the sealing device comprising;

a puncture frame including a plurality of proximal fingers and a plurality of distal fingers;

a twisting frame; and

a flexible tubular sealing member secured between the puncture frame and the twisting frame, wherein the flexible tubular sealing member can be twisted between an open state that allows access through the aperture in the vessel sidewall, and a sealed state in which the vessel sidewall aperture is closed; and

a delivery assembly comprising;

a first generally elongate member configured for placement through the vessel aperture to carry the distal fingers of the puncture frame inside of the vessel through the aperture; and

a second generally elongate member configured for releasable coupling to the twisting frame of the sealing device;

wherein the proximal fingers of the puncture frame are movable between a retracted configuration in which the proximal fingers are relatively close to the first elongate member of the delivery assembly, and a deployed configuration in which the proximal fingers are engaged with tissue on a proximal side of the vessel sidewall around the vessel aperture;

wherein the distal fingers of the puncture frame are movable between a retracted configuration in which the distal fingers are relatively close to the first elongate member of the delivery assembly, and a deployed configuration in which the distal fingers are engaged with tissue on a distal side of the vessel sidewall around the vessel aperture and in which the distal fingers and the proximal fingers cooperate to secure the puncture frame in place and against rotation in the vessel aperture;

wherein the twisting frame is rotatable with respect to the puncture frame by rotation of the second generally elongate member with respect to the vessel sidewall aperture when the puncture frame is secured by the proximal and distal fingers of the puncture frame in place and against rotation in the vessel aperture, to twist the flexible tubular sealing member from its open state to its sealed state, thereby to close the vessel sidewall aperture; and

wherein the second generally elongate member of the delivery assembly is configured for release from the twisting frame of the sealing device to allow the withdrawal of the first and second generally elongate members of the delivery assembly from the medical patient while leaving the closed sealing device in place in the vessel sidewall aperture.