APPARATUS AND METHODS FOR SEALING A VASCULAR PUNCTURE

• US 20120053621A1
• Filed: 10/03/2011
• Published: 03/01/2012
• 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
• Granted Patent: US 9,364,206 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 2017/00557 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. An apparatus for sealing a puncture extending through tissue having an introducer sheath therein, comprising:

a cartridge comprising a proximal end, a distal end sized for insertion through an introducer sheath within a puncture through tissue, a lumen extending between the proximal and distal ends;

a locking element on the cartridge comprising an extension sized for introduction into the proximal end of the introducer sheath when the cartridge is inserted into the introducer sheath;

a sealant disposed within the lumen of the cartridge; and

a pusher member disposed within the cartridge lumen for deploying the sealant distally from the cartridge lumen when the cartridge is retracted proximally relative to the pusher member.

2. The apparatus of claim 1, wherein the extension comprises one or more detents for coupling the introducer sheath to the cartridge when the cartridge is advanced into the introducer sheath lumen such that subsequent proximal movement of the cartridge causes corresponding proximal movement of the introducer sheath such that sealant is deployed beyond the introducer sheath distal end.

3. The apparatus of claim 2, wherein the one or more detents are compressible radially inwardly to accommodate insertion into a proximal end of the introducer sheath and resiliently expandable to an enlarged condition to engage one or more mating features within the introducer sheath.

4. A system for sealing a puncture extending through tissue, comprising:

an introducer sheath comprising a proximal end, a distal end sized for insertion through a puncture through tissue, and a lumen extending between the proximal and distal ends;

a tubular member comprising a proximal end, a distal end sized for insertion into the introducer sheath lumen, a lumen extending between the tubular member proximal and distal ends;

a sealant disposed within the tubular member lumen; and

a locking element carried on the tubular member for coupling the introducer sheath to the tubular member when the tubular member is advanced into the introducer sheath lumen such that subsequent proximal movement of the tubular member causes corresponding proximal movement of the introducer sheath such that sealant is deployed beyond the introducer sheath distal end.

5. The system of claim 4, wherein the introducer sheath comprises an abutment within the introducer sheath proximal end configured to engage a mating feature on the locking element when the mating feature is received within the introducer sheath proximal end.

6. The system of claim 4, wherein the locking element comprises one or more detents for engaging one or more mating features within the introducer sheath proximal end when the tubular member is advanced into the introducer sheath to couple the introducer sheath to the locking element.

7. The system of claim 6, wherein the one or more detents are compressible radially inwardly to accommodate insertion into the introducer sheath proximal end and resiliently expandable to an enlarged condition to engage the one or more mating features within the introducer sheath.

8. The system of claim 6, wherein the one or more detents are carried on a sleeve on the tubular member.

9. The system of claim 8, wherein the sleeve is free to float on the tubular member.

10. The system of claim 9, wherein the tubular member comprises one or more second detents for engaging the locking element when the tubular member is advanced into the introducer sheath to couple the locking element to the tubular member.

11. The system of claim 6, wherein the locking element comprises a sleeve on the tubular member and an extension extending distally from the sleeve, the extension sized for insertion into the introducer sheath proximal end and comprising the one or more detents thereon.

12. An apparatus for sealing a puncture extending through tissue having an introducer sheath therein, comprising:

a cartridge comprising a proximal end, a distal end sized for insertion through an introducer sheath within a puncture through tissue, a lumen extending between the proximal and distal ends;

a locking element carried on the cartridge sized for introduction into a proximal end of an introducer sheath and comprising one or more features for engaging the proximal end of the introducer sheath when the cartridge is inserted into the introducer sheath to thereby couple subsequent proximal movement of the introduced sheath to proximal movement of the cartridge;

a sealant disposed within the lumen of the cartridge; and

a pusher member disposed within the tubular member lumen for deploying the sealant distally from the tubular member lumen when the tubular member is retracted proximally relative to the pusher member.

13. The apparatus of claim 12, wherein the one or more features comprise one or more detents compressible radially inwardly to accommodate insertion into a proximal end of the introducer sheath and resiliently expandable to an enlarged condition to engage one or more mating features within the introducer sheath.

14. The apparatus of claim 13, wherein the locking element comprises a sleeve disposed around the tubular member, the sleeve comprising an extension sized for introduction into the proximal end of the introducer sheath, the extension carrying the one or more detents.

15. 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 until a locking element on the tubular member is received within and engages 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.

16. The method of claim 15, wherein the locking element comprises one or more detents, the one or more detents engaging one or more mating features within the introducer sheath when the tubular member is advanced into the introducer sheath to couple the introducer sheath to the locking element.

17. The method of claim 16, wherein the locking element comprises a sleeve slidably disposed on the tubular member, the sleeve comprising the one or more detents.

18. The method of claim 16, 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.

19. The method of claim 18, 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.