SEALING DEVICES, RELATED DELIVERY APPARATUSES, AND USES THEREOF

• US 20150142049A1
• Filed: 11/20/2014
• Published: 05/21/2015
• 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
• Granted Patent: US 9,775,591 B2
• Time in Patent Office: Days
• US Class Current: 606/216
• 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 for closing an aperture in a vessel sidewall in a subject, comprising:

an annular puncture frame comprising a longitudinal axis, a plurality of proximal fingers coupled to a proximal end of the frame, and a plurality of distal fingers coupled to a distal end of the frame;

wherein

the proximal and distal fingers extend radially outward from the longitudinal axis when the annular frame is in a non-constrained state; and

the distal fingers can be moved to a constrained state pointing in a substantially axial direction for insertion through the aperture in the vessel sidewall and can self-extend to the non-constrained state, thereby pinching the vessel sidewall between the proximal and distal fingers; and

a tubular sealing member comprising a distal end coupled to the puncture frame, the tubular sealing member comprising an open state that allows access to a lumen of the vessel via the aperture; and

wherein the tubular sealing member can be moved to a sealed state to close the aperture in the vessel sidewall.

2. The sealing device of claim 1, further comprising a sealing skirt coupled to the puncture frame.

3. The sealing device of claim 1, wherein the tubular sealing member can be angularly rotated to twist the tubular sealing member to the sealed state to close the aperture in the vessel sidewall.

4. The sealing device of claim 3, wherein a proximal end of the tubular sealing member is coupled to a twisting frame, and wherein the twisting frame can be angularly rotated to twist the tubular sealing member to the sealed state to close the aperture in the vessel sidewall.

5. The sealing device of claim 4, wherein the twisting frame can be secured to the puncture frame to maintain the tubular sealing member in the sealed state.

6. The sealing device of claim 1, further comprising a sealing skirt coupled to the puncture frame, wherein the twisting frame comprises one or more distally extending tines that can bind the sealing skirt to secure the twisting frame to the puncture frame.

7. The sealing device of claim 4, wherein the twisting frame and the puncture frame comprise one or more connection posts that interlock to secure the twisting frame to the puncture frame.

8. The sealing device of claim 1, wherein a proximal end of the tubular sealing member is coupled to a sleeve for holding a suture loop that can be tightened to radially collapse the tubular sealing member to a sealed state to close the aperture in the vessel sidewall.

9. The sealing device of claim 8, further comprising the suture loop.

10. The sealing device of claim 9, further comprising a suture clip for tightening the suture loop to radially collapse and maintain the tubular sealing member to the sealed state to close the aperture in the vessel sidewall.

11. A method of closing an aperture in a vessel sidewall in a subject, comprising:

providing the sealing device of claim 1 mounted on a delivery apparatus;

inserting the sealing device into the aperture in the vessel in the subject; and

sealing the tubular sealing member of the sealing device to close the aperture in the vessel sidewall.

12. The method of claim 11, wherein sealing the tubular sealing member comprises angularly rotating the tubular sealing member to twist the tubular sealing member to the sealed state, thereby closing the aperture in the vessel sidewall.

13. The method of claim 12, wherein a proximal end of the tubular sealing member is coupled to a twisting frame, the method further comprising:

angularly rotating the twisting frame to angularly rotate the tubular sealing member to twist the tubular sealing member to the sealed state, thereby closing the aperture in the vessel sidewall.

14. The method of claim 10, wherein the proximal end of the tubular sealing member is coupled to a sleeve for holding a suture loop, and wherein the method further comprises:

tightening the suture loop to radially collapse the tubular sealing member to the sealed state.

15. A delivery apparatus for inserting a sealing device in a vessel sidewall, comprising the sealing device of claim 1, mounted on the delivery apparatus

16. The delivery apparatus of claim 15, comprising:

a nose cone comprising a hollow chamber that opens proximally, wherein the distal fingers of the sealing device are positioned around an interior sidewall of the hollow chamber of the nose cone and the proximal fingers of the sealing device are positioned around an exterior sidewall of the nose cone, and wherein the proximal and distal fingers extend distally in the direction of the longitudinal axis of the sealing device.

17. The delivery apparatus of claim 16, further comprising a proximal fingers actuator operably connected to the proximal fingers of the sealing device, wherein retraction of the proximal fingers actuator proximally along the longitudinal axis of the sealing device moves the proximal fingers to a position extending radially relative to the longitudinal axis of the sealing device.

18. The delivery apparatus of claim 16, wherein the sealing device comprises a twisting frame secured to the tubular sealing member, the delivery apparatus further comprising:

a twisting frame actuator secured to the twisting frame wherein angularly rotating the twisting frame angularly rotates the tubular sealing member to twist the tubular sealing member to the sealed state.

19. The delivery apparatus of claim 16, wherein the nose cone is operably connected to a biasing element that can produce a biasing force to move the nose cone distally in the direction of the longitudinal axis of the sealing device.

20. The delivery apparatus of claim 19, wherein the biasing element is a spring.