Apparatus and methods for sealing a vascular puncture

• US 9,364,206 B2
• Filed: 10/03/2011
• Issued: 06/14/2016
• Est. Priority Date: 04/04/2008
• Status: Active Grant

• Current Assignee: Access Closure Incorporated (Cardinal Health, Inc.)
• Original Assignee: Access Closure Incorporated (Cardinal Health, Inc.)
• Inventors: Bagaoisan, Celso J., Duong, Sieu, Co, Fred H., Domingo, Juan
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US13/252,061
• Publication Number:
  US 20120053621A1
• Time in Patent Office: 1,716 Days
• Field of Search: 606/213, 604/96.01, 604506-510, 604/513, 604/104
• US Class Current: 1/1
• 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 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid

Abstract

Apparatus and methods for sealing a puncture through tissue includes an introducer sheath sized for introduction into a puncture, cartridge sized for insertion into the introducer carrying a sealant, and a locking element for coupling the introducer sheath to the cartridge. When the cartridge is advanced into the introducer sheath, the locking element couples the introducer sheath to the cartridge such that subsequent retraction of the cartridge causes the introducer sheath to retract, thereby deploying the sealant from the cartridge within the puncture beyond the introducer sheath.

Claims

1. A method for sealing a puncture extending through tissue to a body lumen, comprising:

introducing an introducer sheath into the puncture;

advancing a tubular member carrying a sealant therein into the introducer sheath;

engaging a plurality of outwardly projecting barbs circumferentially disposed about a distal tip of a tubular extension on the tubular member with a proximal end of the introducer sheath to couple the introducer sheath to the tubular member; and

retracting the tubular member at least partially from the puncture, thereby retracting the introducer sheath with the tubular member at least partially from the puncture and exposing the sealant within the puncture distally beyond the introducer sheath,

wherein the step of engaging comprises passing the distal tip of the tubular extension and the plurality of barbs beyond abutment features disposed on the introducer sheath.

2. The method of claim 1, wherein, in the engaging step, a locking element comprises the plurality of barbs on the distal tip of the tubular extension to engage with the introducer sheath.

3. The method of claim 2, wherein the locking element further comprises a sleeve disposed on the tubular member and an extension extending from the sleeve that is inserted into the introducer sheath proximal end when the tubular member is advanced into the introducer sheath.

4. The method of claim 3, wherein the barbs extend radially from the sleeve.

5. The method of claim 1, wherein advancing a tubular member carrying a sealant therein into the introducer sheath comprises advancing the tubular member such that the barbs are compressed radially inwardly as the barbs pass through the abutment features and resiliently expand beyond the abutment features, thereby engaging the expanded barbs with the abutment features to couple the introducer sheath to the tubular member.

6. The method of claim 5, wherein the barbs comprise ramped distal surfaces that engage the abutment features as the barbs enter the introducer sheath to compress the barbs radially inwardly.

7. The method of claim 1, wherein the abutment features comprise one or more seals within a hub on the proximal end of the introducer sheath.

8. A method for sealing a puncture extending through tissue to a body lumen, comprising:

introducing an introducer sheath into the puncture;

advancing a tubular member carrying a sealant therein into the introducer sheath;

engaging a plurality of outwardly projecting barbs circumferentially disposed about the tubular member with a proximal end of the introducer sheath to couple the introducer sheath to the tubular member; and

retracting the tubular member at least partially from the puncture, thereby retracting the introducer sheath with the tubular member at least partially from the puncture and exposing the sealant within the puncture distally beyond the introducer sheath,

wherein the step of engaging comprises passing the plurality of barbs beyond abutment features disposed on the introducer sheath,

wherein, in the engaging step, a locking element is disposed about the tubular member, and the locking element comprises the plurality of barbs to engage with the introducer sheath, wherein the locking element comprises a sleeve disposed on the tubular member and an extension extending from the sleeve that is inserted into the introducer sheath proximal end when the tubular member is advanced into the introducer sheath, and

wherein the extension is expandable from a contracted condition to accommodate insertion into the introducer sheath and an expanded condition when the tubular member is advanced distally into the introducer sheath to prevent subsequent removal of the extension from the introducer sheath.

9. A method for sealing a puncture extending through tissue to a body lumen, comprising:

introducing an introducer sheath into the puncture;

advancing a tubular member carrying a sealant therein into the introducer sheath;

engaging a plurality of outwardly projecting barbs circumferentially disposed about the tubular member with a proximal end of the introducer sheath to couple the introducer sheath to the tubular member; and

retracting the tubular member at least partially from the puncture, thereby retracting the introducer sheath with the tubular member at least partially from the puncture and exposing the sealant within the puncture distally beyond the introducer sheath,

wherein, in the engaging step, a locking element is disposed about the tubular member, and the locking element comprises the plurality of barbs to engage with the introducer sheath,

wherein the locking element is a tubular sleeve, and

wherein the sleeve is freely slidable when not engaged with the introducer sheath.

10. A method for sealing a puncture extending through tissue to a body lumen, comprising:

introducing an introducer sheath into the puncture;

advancing a tubular member carrying a sealant therein into a proximal end of the introducer sheath such that a plurality of outwardly projecting barbs circumferentially disposed about the tubular member are compressed radially inwardly as the barbs pass through an abutment in the introducer sheath proximal end and resiliently expand beyond the abutment, thereby engaging the expanded barbs with the abutment to couple the introducer sheath to the tubular member;

withdrawing a positioning element to contact the vessel wall prior to the retracting step; and

after the withdrawing step, retracting the tubular member at least partially from the puncture, thereby retracting the introducer sheath with the tubular member at least partially from the puncture and exposing the sealant within the puncture distally beyond the introducer sheath;

wherein the plurality of outwardly extending barbs are on a distal tip of a tubular extension on the tubular member, and

wherein the distal tip of the tubular extension and the plurality of barbs pass beyond the abutment when tubular member is advanced into the introducer sheath.

11. The method of claim 10, wherein the positioning element is radially enlargeable.

12. The method of claim 10, wherein the barbs comprise ramped distal surfaces that engage the abutment as the barbs enter the introducer sheath to compress the barbs radially inwardly.

13. The method of claim 10, wherein the abutment comprises one or more seals within a hub on the proximal end of the introducer sheath.

14. The method of claim 10, wherein the plurality of outwardly extending barbs comprise sloped distal edges coupled to the tubular extension and blunt proximal ends that are compressed radially inwardly as the barbs pass through an abutment in the introducer sheath proximal end and resiliently expand beyond the abutment, thereby engaging the expanded blunt proximal ends of the barbs with the abutment.