SYSTEMS AND METHODS FOR SEALING OPENINGS IN AN ANATOMICAL WALL

• US 20150032153A1
• Filed: 07/25/2014
• Published: 01/29/2015
• Est. Priority Date: 07/26/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Cardiaq Valve Technologies Incorporated
• Inventors: Ratz, J. Brent, QUADRI, ARSHAD, Rabito, Glen, Johnson, Garrett
• Granted Patent: US 9,724,083 B2
• Time in Patent Office: Days
• US Class Current: 606/215
• 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 17/3421 Cannulas
• 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 2017/00243 cardiac
• 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 2017/0061 Implements located only on one side of the opening
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/3435 using everted sleeves
• CPC Class Codes: A61M 60/13 by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/178 drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
• CPC Class Codes: A61M 60/216 including a rotating member acting on the blood, e.g. impeller
• CPC Class Codes: A61M 60/414 transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
• CPC Class Codes: A61M 60/861 Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body

Abstract

Devices, systems and methods are described herein for sealing openings in an anatomical wall. A sealing system includes an elongate tubular support for delivery to an anatomical opening to be sealed, a cover of bio-compatible material covering a distal portion of the tubular support, and an anchor assembly, the anchor assembly being designed to secure the cover material to the opening. The anchor assembly can include a plurality of distal anchors and a plurality of proximal anchors, a button, ring or donut, and/or a C-clip. In some embodiments, the system further comprises a closure member for closing off an end of the cover material after removal of the tubular support.

Claims

1. A percutaneous puncture seal system for sealing openings within an anatomical wall, the system comprising:

an elongate tubular support having a distal end and a proximal end, the tubular support configured for percutaneous delivery to the opening to be sealed;

a cover of bio-compatible material configured to cover at least a portion of the tubular support from at least the distal end of the tubular support to a central portion of the tubular support, the cover material having a distal end configured to engage the distal end of the tubular support and a proximal end, the cover further comprising an anchor covering portion positioned proximate the proximal end of the cover; and

an anchor assembly comprising a plurality of distal anchors and a plurality of proximal anchors positioned proximal the central portion of the tubular support, the distal and proximal anchors sufficiently malleable and configured to be foldable against the tubular support when in a first delivery position, and to foldable radially outwardly away from the tubular support in a second wall engagement position;

wherein, when puncture seal system is deployed in-situ within an opening so that the distal anchors are positioned along the distal side of the opening wall and the proximal anchors are positioned along the proximal side of the opening wall, the anchors may be positioned in the wall engagement position to secure the seal system in place and permit actuation of the system to seal the opening by removing the tubular support and drawing the cover material inside-out from a distal-most position to a proximal-most position, wherein the opening is sealed using the anchor covering portion of the cover material in combination with the anchors.

2. The seal system of claim 1, further comprising a closure member for closing off an end of the cover material after removal of the tubular support.

3. A method of sealing openings within an anatomical wall, the method comprising:

delivering percutaneously a puncture seal closure system within a sheath to an opening in an anatomical wall to be sealed, where the system comprises an elongate tubular support having a distal end and a proximal end, the tubular support configured for percutaneous delivery to the opening to be sealed;

a cover of bio-compatible material configured to cover at least a portion of the tubular support from at least the distal end of the tubular support to a central portion of the tubular support, the cover material having a distal end configured to engage the distal end of the tubular support and a proximal end, the cover further comprising an anchor covering portion positioned proximate the proximal end of the cover; and

an anchor assembly comprising a plurality of distal anchors and a plurality of proximal anchors positioned proximal the central portion of the tubular support, the distal and proximal anchors sufficiently malleable and configured to be foldable against the tubular support when in a first delivery position, and to foldable radially outwardly away from the tubular support in a second wall engagement position;

positioned the puncture seal system in-situ within the opening so that the distal anchors are positioned along the distal side of the opening wall and the proximal anchors are positioned along the proximal side of the opening wall;

withdrawing the sheath to permit the anchors may be positioned in the wall engagement position to secure the seal system in place;

removing the tubular support in a proximal direction so as to draw the cover material inside-out from a distal-most position to a proximal-most position;

severing the exposed end of the cover material with a closure member for closing off an end of the cover material after removal of the tubular support wherein the opening may sealed using the anchor covering portion of the cover material in combination with the anchors.

4. A system for sealing an opening within an anatomical wall, the system comprising:

an elongate tubular support having a proximal end and a distal end, the tubular support configured for delivery into the opening to be sealed;

an anchor assembly configured to be secured to the anatomical wall adjacent the opening, wherein the elongate tubular support is positionable in a first position within the anchor assembly wherein the proximal end of the tubular support is proximal to the anchor assembly and the distal end of the tubular support is distal to the anchor assembly; and

a cover of bio-compatible material connected to the anchor assembly and configured to extend distally from the anchor assembly to cover at least a portion of the tubular support when the tubular support is in the first position;

wherein the tubular support is moveable from the first position to a second position, wherein in the second position the distal end of the tubular support is proximal to the anchor assembly, and movement of the tubular support from the first position to the second position draws the cover material inside-out such that the cover material extends proximally from the anchor assembly.

5. The system of claim 4, wherein the anchor assembly comprises a plurality of proximal anchors and a plurality of distal anchors, the proximal and distal anchors being foldable towards the tubular support in a first delivery position and being expandable radially outwardly away from the tubular support in a second wall engagement position.

6. The system of claim 5, wherein the cover is connected to the distal anchors.

7. The system of claim 5, wherein the cover is connected to the proximal anchors.

8. The system of claim 4, wherein the anchor assembly comprises a C-clip.

9. The system of claim 4, wherein the anchor assembly comprises a button or ring that is securable adjacent an opening in the anatomical wall.

10. The system of claim 4, wherein the cover is connected to the tubular support at or proximate the distal end of the tubular support.

11. The system of claim 4, wherein when the tubular support is in its first position, the cover extends to the distal end of the tubular support and is then inverted to extend within a lumen of the tubular support.

12. The system of claim 11, wherein the cover is connected to the tubular support at or proximate the proximal end of the tubular support within the lumen.

13. A method of sealing an opening within an anatomical wall, the method comprising:

providing a sealing system comprising an elongate tubular support having a proximal end and a distal end, an anchor assembly provided over the elongate tubular support positioned between the proximal and distal ends, and a cover of bio-compatible material connected to the anchor assembly and extending distally therefrom to cover at least a portion of the tubular support;

positioning the tubular support within the opening within the anatomical wall such that the proximal end of the tubular support is proximal of the opening and the distal end of the tubular support is distal of the opening, wherein the cover covering at least a portion of the tubular support extends at least distally of the opening;

securing the anchor assembly to the anatomical wall adjacent the opening;

moving the tubular support in a proximal direction so as to draw the cover material inside-out from a distal-most position wherein the cover extends at least distally of the opening to a proximal-most position wherein the cover extends proximally of the opening; and

sealing a portion of the cover extending proximally of the opening.

14. The method of claim 13, further comprising severing a portion of the cover extending proximally of the opening.

15. The method of claim 13, wherein the opening within the anatomical wall is formed by delivering the sealing system through the anatomical wall.

16. The method of claim 15, wherein delivering the sealing system further comprises delivering a dilator through the anatomical wall simultaneously with the tubular support.

17. The method of claim 13, wherein securing the anchor assembly to the anatomical wall comprises expanding anchors on proximal and distal sides of the anatomical wall.

18. The method of claim 13, wherein securing the anchor assembly comprising suturing the anchor assembly to a proximal surface of the anatomical wall adjacent the opening.

19. The method of claim 13, wherein the opening is an opening in the heart.

20. The method of claim 13, further comprising performing a procedure in the heart using one or more instruments delivered through a central lumen of the tubular support after securing the anchor assembly to the anatomical wall adjacent the opening and before moving the tubular support in a proximal direction so as to draw the cover material inside-out from a distal-most position wherein the cover extends at least distally of the opening to a proximal-most position wherein the cover extends proximally of the opening.