Plug with detachable guidewire element and methods for use

• US 8,409,248 B2
• Filed: 07/09/2010
• Issued: 04/02/2013
• Est. Priority Date: 12/14/2000
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Ensure Medical, Inc. (Cardinal Health, Inc.), Core Medical Incorporated
• Inventors: Ginn, Richard S, Wallace, Daniel T, LaDuca, Robert C
• Primary Examiner(s): WOO, JULIAN W
• Application Number:
  US12/833,643
• Publication Number:
  US 20100274281A1
• Time in Patent Office: 998 Days
• Field of Search: 606/108, 606/113, 606/127, 606/151, 606/153, 606/213, 606/232, 600/585
• 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 2010/0003 including means for analysis by an unskilled person
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• 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 2017/00898 expandable upon contact with fluid

Abstract

An apparatus for sealing a passage through tissue includes a bioabsorbable, threaded plug carried by a delivery device. A guide wire is receivable through lumens in the plug and delivery device that includes wings on a bioabsorbable distal portion. With the wings collapsed, the guide wire is advanced through the passage into a blood vessel, the wings expanding once located within the vessel, and the guide wire is withdrawn until the wings contact the vessel wall. The plug is threaded into the passage over the guide wire until the plug is disposed adjacent the wings. The distal portion of the guide wire is secured to the plug, e.g., by compressing a collet within the plug lumen that seals the lumen, and is severed from a proximal portion thereof. Thus, the plug and distal portion are deployed with the plug sealing the passage.

Claims

1. An apparatus for sealing a passage through tissue in a body, comprising:

an elongate delivery device comprising a lumen extending between proximal and distal ends thereof;

a plug member detachably carried by the distal end of the delivery device and comprising a lumen communicating with the lumen of the delivery device, wherein the plug member is configured to be inserted through the tissue;

a guide wire element comprising a proximal end receivable through the lumens in the plug member and the delivery device, the guide wire element comprising a plurality of lateral elements on a distal portion thereof, the plurality of lateral elements having an expanded position and a collapsed position substantially parallel to the delivery device; and

a visual indicator located on a proximal portion of the guide wire element and spaced from the proximal end of the guide wire element and configured for indicating the position of the plug member relative to the plurality of lateral elements in the expanded position.

2. The apparatus of claim 1, wherein the visual indicator includes a marking on the guide wire element.

3. The apparatus of claim 1, wherein the visual indicator indicates when the plug member is adjacent to the plurality of lateral elements.

4. The apparatus of claim 1, wherein the visual indicator includes colored markings on the guide wire element.

5. The apparatus of claim 1, wherein the visual indicator includes a first marking on the guide wire element indicating the plug member is over the distal portion of the guide wire adjacent to the plurality of lateral elements.

6. The apparatus of claim 1, wherein the visual indicator includes a second marking on the guide wire element indicating the plug member is over an intermediate portion of the guide wire.

7. The apparatus of claim 1 wherein the guide wire element comprises a bleed back lumen therein extending proximally from the distal end, the bleed back lumen providing a visual indication that the distal end of the guide wire has been advanced into the body lumen.

8. The apparatus of claim 1 wherein the plurality of lateral elements comprises at least two opposing legs extending away from one another in the expanded confirmation.

9. The apparatus of claim 1 wherein the plug member comprises a bioabsorbable material.

10. The apparatus of claim 1 wherein the plug member comprises threads on an exterior surface of the plug member.

11. The apparatus of claim 1 wherein the plug member comprises a collet within the lumen of the plug member.

12. The apparatus of claim 11 wherein the collet has a conical outer surface and the lumen of the plug member has a tapered inner surface.

13. A method for sealing a passage through tissue from a patient'"'"'s skin to a body lumen, comprising:

advancing a distal end of a guide wire element from the patient'"'"'s skin through the passage and into the body lumen, the guide wire element comprising one or more lateral elements on the distal end of the guide wire element and also comprising a distal portion separately coupled to a proximal region;

partially withdrawing the guide wire element from the body lumen until the one or more lateral elements contacts a wall of the body lumen;

advancing a plug member detachably carried by the distal end of the delivery device into the passage while the guide wire element is within a plug member lumen and a delivery device lumen until a visual indicator located on a proximal portion of the guide wire element and spaced from a proximal end of the guide wire element indicates that the plug member is adjacent to the one or more lateral elements; and

decoupling and removing a proximal portion of the guide wire element from the passage.

14. The method of claim 13, wherein the visual indicator indicates that the plug member is adjacent to the one or more lateral elements by exposing a marking on the guide wire element.

15. The method of claim 13, wherein the visual indicator includes colored markings on the guide wire element and the advancing of the plug member is stopped when the colored marking is exposed from the lumen of the delivery device.

16. The method of claim 13 wherein the guide wire element comprises a bleed back lumen therein extending proximally from the distal end and the advancing of the distal end of the guide wire element is stopped after the bleed back lumen providing a visual indication that the distal end of the guide wire has been advanced into the body lumen.

17. The method of claim 13 further comprising:

extending at least two opposing legs away from one another to expand the lateral elements after advancing the distal end of the guide wire element into the body lumen.

18. The method of claim 13 wherein the plug member comprises a bioabsorbable material and the plug member is absorbed by the passage under the patient'"'"'s skin after the decoupling and removing the proximal portion of the guide wire element from the passage.

19. The method of claim 13 wherein the plug member comprises a collet within the lumen of the plug member and the collet seals the lumen after the decoupling and removing the proximal portion of the guide wire element from the passage.