Locator and closure device and method of use

• US 8,926,654 B2
• Filed: 04/14/2008
• Issued: 01/06/2015
• Est. Priority Date: 05/04/2005
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Ginn, Richard S., Palermo, Thomas J.
• Primary Examiner(s): Nguyen, Tuan V
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US12/102,728
• Publication Number:
  US 20080221615A1
• Time in Patent Office: 2,458 Days
• Field of Search: 606/213, 606/232
• 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 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/2923 Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2090/0807 Indication means

Abstract

The present invention is directed to a method for sealing a puncture in a wall of a lumen of a body including the steps of deploying a deployment member of a sealing device through an elastic membrane adjacent the wall of the lumen and the puncture, wherein the sealing device includes a sealing element; positioning the sealing element adjacent the wall of the lumen; retracting the deployment member relative to the sealing element to stretch the membrane away from the wall of the lumen; retracting the deployment member relative to the sealing element to allow the elastic nature of the membrane to force the sealing element against the puncture; and retracting the device from the puncture.

Claims

1. A method for sealing a puncture, having an edge, in a wall of a lumen of a body comprising:

a) deploying a deployment member of a sealing device through an elastic tissue membrane adjacent an outer wall of the lumen and the puncture, wherein the sealing element is disposed within a distal portion of the deployment member and wherein the distal portion of the deployment member has a uniform diameter greater than the sealing element;

b) positioning, outside the lumen, a maximal radial diameter portion of the sealing element adjacent the outer wall of the lumen and the edge of the puncture;

c) retracting the deployment member relative to the sealing element while maintaining the uniform diameter of the deployment member to stretch the elastic membrane away from the wall of the lumen and allow the elastic membrane to engage the sealing element so as to urge the maximal radial diameter portion of the sealing element positioned outside the lumen towards the outer wall of the lumen and the edge of the puncture; and

d) retracting the device from the body to leave the maximal radial diameter portion of the sealing element outside the lumen adjacent the outer wall and the edge of the puncture.

2. The method of claim 1, wherein the elastic membrane is a fascia.

3. The method of claim 2, wherein the fascia comprises a portion of a femoral sheath.

4. The method of claim 3, wherein the lumen of the body comprises a femoral artery.

5. The method of claim 1, wherein the sealing element is positioned between the membrane and the wall of the lumen when the membrane engages the sealing element.

6. The method of claim 1, wherein the sealing element partially protrudes from the membrane when the membrane engages the sealing element.

7. The method of claim 1, wherein membrane retains the sealing element at a desired position adjacent the wall of the lumen.

8. The method of claim 7, wherein the membrane urges the sealing element against the wall of the lumen.

9. The method of claim 1, wherein the sealing element further includes an indicator wire having a distal tip;

and further comprising the steps of extending the indicator wire out of the deployment member when the sealing element is deployed through the puncture;

adjusting the position of the sealing element until the indicator wire is adjacent to the edge of the puncture; and

retracting the indicator wire into the device.

10. A method for sealing a puncture, having an edge, in a wall of a lumen of a body comprising:

a) deploying a deployment member of a sealing device through an elastic membrane adjacent the wall of the lumen and the puncture, wherein the deployment member is a single tubular member carrying a sealing element, wherein the sealing element is disposed within a distal portion of the deployment member and wherein the distal portion of the deployment member has a uniform diameter greater than the sealing element;

b) positioning the sealing element within the lumen;

c) withdrawing the sealing element outside the lumen adjacent the wall of the lumen;

d) frictionally engaging the membrane with the deployment member;

e) retracting the deployment member relative to the sealing element while maintaining the uniform diameter of the deployment member to stretch the membrane away from the wall of the lumen;

f) disengaging the deployment member from the membrane; and

g) retracting the device from the body to leave the sealing element adjacent the wall of the lumen.

11. A method for positioning a sealing element adjacent a puncture, having an edge, in a wall of a lumen of a body comprising:

a) deploying a deployment member of a sealing device through an elastic membrane adjacent the wall of the lumen and the puncture, wherein the deployment member is a single tubular member carrying a sealing element;

b) positioning the sealing element carried by the sealing device adjacent the wall of the lumen, wherein the sealing element is configured to be disposed between the wall of the lumen and the elastic membrane when the elastic membrane is elastically displaced, wherein the sealing element is disposed within a distal portion of the deployment member and wherein the distal portion of the deployment member has a uniform diameter greater than the sealing element;

c) retracting the deployment member while maintaining the uniform diameter of the deployment member to elastically displace the elastic membrane away from the wall of the lumen;

d) deploying the sealing element by releasing it from the sealing device;

e) disengaging the deployment member from the elastic membrane, wherein the elastic membrane elastically urges the sealing member against the wall of the lumen; and

f) retracting the device from the body to leave the sealing element adjacent the wall of the lumen.