Apparatus and methods for sealing a vascular puncture

• US 10,512,455 B2
• Filed: 05/13/2016
• Issued: 12/24/2019
• 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:
  US15/154,063
• Publication Number:
  US 20160324511A1
• Time in Patent Office: 1,320 Days
• 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 a tissue having an introducer sheath therein, comprising:

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

a locking element on the cartridge comprising an extension that has at least one first detent, the extension and the at least one first detent sized for introduction into a lumen of the introducer sheath when the cartridge is inserted into the introducer sheath, wherein the cartridge is coupled to at least one second detent, and wherein the locking element comprises a sleeve with a passage therethrough configured to receive the at least one second detent to thereby couple the cartridge to the locking element;

a sealant disposed within the lumen of the cartridge; and

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

2. The apparatus of claim 1, wherein the locking element is configured to couple the introducer sheath to the cartridge such that, when the cartridge is advanced into the lumen of the introducer sheath, a subsequent proximal movement of the cartridge causes a corresponding proximal movement of the introducer sheath such that the sealant is deployed beyond the distal end of the introducer sheath.

3. The apparatus of claim 1, wherein the at least one first detent is one or more detents are compressible radially inwardly to accommodate insertion into the lumen 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 a tissue comprising:

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

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

a sealant disposed within the lumen of 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 and the locking element are advanced into the lumen of the introducer sheath such that a subsequent proximal movement of the tubular member causes a corresponding proximal movement of the introducer sheath such that the sealant is deployed beyond the introducer sheath distal end of the introducer sheath, wherein the locking element comprises one or more first detents for engaging one or more mating features within the lumen of the introducer sheath when the tubular member is advanced into the introducer sheath to couple the introducer sheath to the locking element, and wherein the tubular member comprises one or more second detents for engaging an inner surface of the locking element when the tubular member is advanced into the introducer sheath to couple the locking element to the tubular member.

5. The system of claim 4, wherein the one or more first detents are compressible radially inwardly to accommodate insertion into the lumen of the introducer sheath and resiliently expandable to an enlarged condition to engage the one or more mating features within the lumen of the introducer sheath.

6. The system of claim 4, wherein the one or more first detents are carried on a sleeve on the tubular member.

7. The system of claim 6, wherein the sleeve is free to float on the tubular member.

8. The system of claim 6, wherein the locking element further comprises an extension extending distally from the sleeve, the extension sized for insertion into the lumen of the introducer sheath and the one or more first detents coupled to the extension.

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

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

a locking element carried on the cartridge and sized for introduction into a lumen of the introducer sheath and comprising one or more first detents for engaging the proximal end of the introducer sheath when the cartridge is inserted into the introducer sheath such that a subsequent proximal movement of the cartridge causes a corresponding proximal movement of the introducer sheath, wherein the cartridge is coupled to at least one second detent, and wherein the locking element comprises a sleeve with a passage therethrough configured to receive the at least one second detent to thereby couple the cartridge to the locking element;

a sealant disposed within the lumen of the cartridge; and

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

10. The apparatus of claim 9, wherein the first one or more detents are compressible radially inwardly to accommodate insertion into the lumen of the introducer sheath and resiliently expandable to an enlarged condition to engage one or more mating features within the introducer sheath.

11. The apparatus of claim 10, wherein the sleeve comprises an extension sized for introduction into the lumen proximal end of the introducer sheath, the extension carrying the first one or more detents.