CLOSURE DEVICE WITH STRING RETRACTABLE UMBRELLA

• US 20100234878A1
• Filed: 03/16/2009
• Published: 09/16/2010
• Est. Priority Date: 03/16/2009
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Hardert, Michael W., Hruska, Christopher L.
• Granted Patent: US 8,029,534 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• 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 2017/00597 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 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0496 for tensioning sutures

Abstract

A repositionable closure device for occluding a body opening is provided. The closure device includes distal and proximal occluding bodies having expandable distal and proximal umbrella frames. Each umbrella frame includes a plurality of struts connected to a biocompatible sheet material. The distal and proximal umbrella frames expand to expanded configurations on opposite sides of the body opening. The struts of the distal umbrella frame terminate with an eyelet. The distal occluding body is connected to a distal end of a center rod and the proximal umbrella frame is slidable along the center rod via a center ring. At least one drawstring is threaded through the eyelets and the center ring, connecting the distal and proximal occluding bodies. The drawstring extends proximally from the center ring. Manipulation of the drawstring and the center rod is configured to collapse the closure device for at least partial retrieval during repositioning.

Claims

1. A closure device for occluding a body opening comprising:

a distal occluding body having an expandable distal umbrella frame and a proximal occluding body having an expandable proximal umbrella frame, the distal frame including a plurality of struts having first ends attached to a distal end of a center rod, the proximal frame including a center ring and a plurality of struts having first ends attached to the center ring, the center ring being slidable along the center rod, the struts of each frame being connected to a biocompatible sheet material, the center rod defining a longitudinal axis, the distal frame struts extending from the distal end of the center rod in a generally parallel, axial direction with respect to the longitudinal axis when the distal frame is in a collapsed configuration and in a generally perpendicular, radial direction with respect to the longitudinal axis when the distal frame is in an expanded configuration, the proximal frame struts extending from the center ring in a generally parallel, axial direction with respect to the longitudinal axis when the proximal frame is in a collapsed configuration and in a generally perpendicular, radial direction with respect to the longitudinal axis when the proximal frame is in an expanded configuration, each strut of the distal frame extending from the first end and terminating with an eyelet, wherein the distal and proximal frames expand to their expanded configurations on opposite sides of the body opening; and

at least one drawstring threaded through the eyelets of the distal frame and through the center ring of the proximal frame to connect the distal and proximal occluding bodies to one another, the at least one drawstring extending proximally from the center ring, wherein manipulation of the center rod and the at least one drawstring extending proximally from the center ring is configured to move the distal and proximal frames from their expanded configurations toward their collapsed configurations for at least partial retrieval of the closure device.

2. The device of claim 1, wherein the at least one drawstring connecting the distal and proximal occluding bodies to one another has a predetermined length such that expansion of the distal frame to its expanded configuration moves the proximal frame distally along the center rod.

3. The device of claim 1, wherein the center rod includes a first portion and a detachable second portion, wherein the detachable second portion detaches from the first portion at a point proximal to the center ring of the proximal frame when the proximal frame is in its expanded configuration.

4. The device of claim 1, wherein the center rod is advanced distally and the at least one drawstring extending proximally from the center ring is pulled proximally during at least partial retrieval of the closure device.

5. The device of claim 1, wherein the struts of the distal frame extend from the distal end of the center rod in a direction toward the proximal occluding body and the struts of the proximal frame extend from the center ring in a direction toward the distal occluding body when the distal and proximal frames are in their collapsed configurations.

6. The device of claim 1, wherein the body opening is defined by surrounding body tissue and includes a distal end and a proximal end, the distal occluding body being configured for placement outside the body opening to engage body tissue adjacent the distal end of the body opening, the proximal occluding body being configured for placement outside the body opening to engage body tissue adjacent the proximal end of the body opening.

7. The device of claim 6, wherein the struts of the distal and proximal frames comprise an arcuate conformation, the struts of the distal frame being biased in a proximal direction against the body tissue adjacent the distal end of the body opening and the struts of the proximal frame being biased in a distal direction against the body tissue adjacent the proximal end of the body opening when the distal and proximal frames are in their expanded configurations.

8. The device of claim 1, wherein the at least one drawstring includes a single drawstring including a first portion connecting the distal and proximal frames to one another and a second portion extending proximally from the center ring.

9. The device of claim 1, wherein the at least one drawstring includes a first drawstring connecting the distal and proximal frames to one another and a second drawstring extending proximally from the center ring.

10. The device of claim 1, wherein the at least one drawstring extending proximally from the center ring includes tails ends which extend proximally from the center ring, wherein a grasping instrument grasps the tail ends during delivery and at least partial retrieval of the closure device.

11. The device of claim 1, wherein the at least one drawstring extending proximally from the center ring includes first and second ends extending through a delivery catheter, wherein the first and second ends of the at least one drawstring are grasped by a physician during delivery and at least partial retrieval of the closure device.

12. The device of claim 1, wherein the biocompatible sheet material is selected from the group consisting of DACRON, PTFE, ePTFE, polyurethane, cotton, silk, wool, polyester, and extracellular matrix material.

13. The device of claim 1, wherein the struts are formed from a material selected from the group consisting of superelastic material, stainless steel wire, Nitinol, cobalt chrome-alloys, and cobalt-chromium-nickel-molybdenum-iron alloy.

14. A closure device assembly for occluding a body opening, the assembly comprising:

a delivery catheter including a proximal and a distal end and a lumen formed through the proximal and distal ends;

a closure device collapsibly disposed within the distal end of the delivery catheter, the closure device including a distal occluding body having an expandable distal umbrella frame and a proximal occluding body having an expandable proximal umbrella frame, the distal frame including a plurality of struts having first ends attached to a distal end of a center rod, the proximal frame including a center ring and a plurality of struts having first ends attached to the center ring, the center ring being slidable along the center rod, the struts of each frame being connected to a biocompatible sheet material, the center rod defining a longitudinal axis, the distal frame struts extending from the distal end of the center rod in a generally parallel, axial direction with respect to the longitudinal axis when the distal frame is in a collapsed configuration and in a generally perpendicular, radial direction with respect to the longitudinal axis when the distal frame is in an expanded configuration, the proximal frame struts extending from the center ring in a generally parallel, axial direction with respect to the longitudinal axis when the proximal frame is in a collapsed configuration and in a generally perpendicular, radial direction with respect to the longitudinal axis when the proximal frame is in an expanded configuration, each strut of the distal frame extending from the first end and terminating with an eyelet, wherein the distal and proximal frames expand to their expanded configurations on opposite sides of the body opening; and

a drawstring threaded through the eyelets of the distal frame and through the center ring of the proximal frame to connect the distal and proximal occluding bodies to one another, the drawstring extending proximally from the center ring, wherein manipulation of the center rod and the drawstring is configured to move the distal and proximal frames from their expanded configurations toward their collapsed configurations for at least partial retrieval of the closure device.

15. The assembly of claim 14, further comprising a grasping instrument for manipulating the drawstring extending proximally from the center ring.

16. A method for closing a body opening in a patient comprising:

positioning a delivery catheter having a proximal end, a distal end, and a lumen formed through the proximal and distal ends within the body opening, the delivery catheter including a closure device collapsibly disposed within the lumen at the distal end of the delivery catheter, the closure device including a distal occluding body having an expandable distal umbrella frame and a proximal occluding body having an expandable proximal umbrella frame, the distal frame including a plurality of struts having first ends attached to a distal end of a center rod, the proximal frame including a center ring and a plurality of struts having first ends attached to the center ring, the center ring being slidable along the center rod, the struts of each frame being connected to a biocompatible sheet material, the center rod defining a longitudinal axis, the distal frame struts extending from the distal end of the center rod in a generally parallel, axial direction with respect to the longitudinal axis when the distal frame is in a collapsed configuration and in a generally perpendicular, radial direction with respect to the longitudinal axis when the distal frame is in an expanded configuration, the proximal frame struts extending from the center ring in a generally parallel, axial direction with respect to the longitudinal axis when the proximal frame is in a collapsed configuration and in a generally perpendicular, radial direction with respect to the longitudinal axis when the proximal frame is in an expanded configuration, each strut of the distal frame extending from the first end and terminating with an eyelet, the closure device further including at least one drawstring threaded through the eyelets of the distal frame and through the center ring of the proximal frame to connect the distal and proximal occluding bodies to one another, the at least one drawstring extending proximally from the center ring; and

deploying the closure device from the delivery catheter about the body opening such that the distal frame of the distal occluding body expands to its expanded configuration at a distal end of the body opening and the proximal frame of the proximal occluding body expands to its expanded configuration at an opposing proximal end of the body opening.

17. The method of claim 16, wherein deploying the closure device from the delivery catheter includes:

positioning the delivery catheter distal to the distal end of the body opening and moving the delivery catheter and the center rod relative to one another to deploy the distal occluding body; and

positioning the delivery catheter proximal to the proximal end of the body opening and moving the delivery catheter and the center rod relative to one another to deploy the proximal occluding body.

18. The method of claim 17, further comprising repositioning the closure device including:

distally advancing the center rod and proximally retracting the at least one drawstring extending proximally from the center ring to at least partially retrieve the closure device, wherein distally advancing the center rod applies a distal force to the distal occluding body near a center of the distal occluding body, wherein proximally retracting the at least one drawstring applies an opposing proximal force to the distal occluding body at the eyelets, the combination of the distal and proximal forces on the distal occluding body causing the eyelets of the struts of the distal frame to move inward towards the body opening collapsing the distal frame;

further retracting the at least one drawstring extending proximally from the center ring and distally advancing the delivery catheter, wherein further retracting the at least one drawstring extending proximally from the center ring moves the proximal occluding body proximally and the distal occluding body proximally via the at least one drawstring connecting the proximal and distal occluding bodies, wherein distally advancing the delivery catheter collapses the proximal frame into its collapsed configuration as the delivery catheter receives the proximal occluding body, wherein the delivery catheter receives the distal occluding body as the at least one drawstring extending proximally from the center ring is retracted further and the delivery catheter is advanced further; and

redeploying the closure device in a more optimal position within the patient.

19. The method of claim 16, wherein the center rod of the closure device includes a first portion and a detachable second portion, the method further comprising withdrawing the delivery catheter from the patient'"'"'s body opening including:

detaching the detachable second portion of the center rod from the first portion at a point proximal to the center ring of the proximal frame when the proximal frame is in its expanded configuration; and

withdrawing the detachable second portion of the center rod.

20. The method of claim 16 wherein the body opening is an atrial septal defect or a patent foramen ovale.