APPARATUS AND METHODS FOR SEALING A VASCULAR PUNCTURE

• US 20120290001A1
• Filed: 05/11/2011
• Published: 11/15/2012
• Est. Priority Date: 05/11/2011
• Status: Active Grant

• Current Assignee: Access Closure Incorporated (Cardinal Health, Inc.)
• Original Assignee: Access Closure Incorporated (Cardinal Health, Inc.)
• Inventors: Uchida, Andy H., To, Kevin, Fell, Brandon, Swenson, Peter A.
• Granted Patent: US 9,386,968 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 2017/00367 Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
• 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 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof

Abstract

An apparatus for sealing a puncture through tissue having an introducer sheath therein includes an elongate positioning member including a housing on a proximal end and an expandable member on a distal end, and a cartridge advanceable along the positioning member from a proximal position to a distal position. The cartridge includes a tubular member including a sealant and an advancer member disposed within lumen of the tubular member. A sleeve is slidably disposed over the tubular member distal end such that, when the tubular member is advanced over the positioning member, the tubular member distal end enters the introducer sheath while the sleeve is stopped and slides over the tubular member to expose the tubular member distal end within the introducer sheath. The introducer sheath and cartridge are then withdrawn, exposing the sealant within the puncture.

Claims

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

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

a positioning member comprising an elongate member including proximal and distal ends, a housing on the proximal end, and an expandable positioning element on the distal end; and

a cartridge advanceable along the positioning member from a proximal position adjacent the housing to a distal position, the cartridge comprising;

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

b) a sealant disposed within the tubular member lumen;

c) an advancer member disposed within the tubular member lumen for exposing the sealant distally from the tubular member lumen when the tubular member is retracted proximally relative to the advancer member; and

d) a sleeve slidably disposed over the tubular member distal end, at least a portion of the sleeve sized to abut the introducer sheath hub such that, when the tubular member is advanced from the proximal position to the distal position, the tubular member distal end enters the introducer sheath lumen through the hub while the sleeve is stopped by the introducer sheath hub and slides over the tubular member to expose the tubular member distal end within the introducer sheath lumen.

2. The system of claim 1, wherein the sleeve comprises a distal portion sized to enter the introducer sheath hub when the cartridge is advanced towards the distal position and a proximal portion that abuts the introducer sheath hub to prevent the entire sleeve from entering the introducer sheath lumen.

3. The system of claim 2, wherein the introducer sheath hub comprises a hemostatic valve therein, and wherein the sleeve distal portion at least partially opens the valve when the cartridge is advanced towards the distal position to facilitate the tubular member distal end entering the introducer sheath lumen.

4. The system of claim 1, wherein the sealant is disposed within the tubular member adjacent the tubular member distal end, and wherein the tubular member comprises a slitted distal tip to facilitate exposure of the sealant from the tubular member distal end when the tubular member is retracted proximally after being advanced to the distal position.

5. The system of claim 1, wherein the sleeve comprises an inner surface configured to provide different frictional interference with an outer surface of the tubular member to allow proximal movement and resist distal movement of the sleeve over the tubular member.

6. The system of claim 1, wherein at least one of the positioning member and the cartridge comprise one or more features that limit further distal movement of the tubular member when the cartridge is advanced from the proximal position to the distal position.

7. The system of claim 6, wherein the one or more features are located to prevent further distal movement of the tubular member when the tubular member distal end is spaced a predetermined distance from the positioning element.

8. The system of claim 1, wherein the sleeve has a relatively short length relative to the tubular member.

9. The system of claim 1, further comprising cooperating elements on the advancer member and the positioning member that limit subsequent proximal movement of the advancer member relative to the positioning member after the cartridge is advanced to the distal position.

10. The system of claim 9, wherein the positioning member is removable through the advancer member with the positioning element collapsed, thereby allowing the positioning member to be withdrawn from a puncture before the advancer member is withdrawn such that advancer member prevents the plug from moving proximally while the positioning member is withdrawn.

11. The system of claim 9, wherein the cooperating elements comprise a first detent on the positioning member over which the advancer member passes when the cartridge is advanced to the distal position, and one or more features on a proximal end of the advancer member that prevent the advancer member from subsequent proximal movement back over the first detent.

12. The system of claim 11, further comprising a second detent on the positioning member distal to the first detent, the advancer member advanceable over the second detent to compress the sealant between a distal end of the advancer member and the expandable positioning element after the cartridge is withdrawn to expose the sealant within a puncture.

13. An apparatus for sealing a puncture extending through tissue having an introducer sheath therein that includes a proximal end including a hub, a distal end, and a lumen extending therebetween, the apparatus comprising:

a positioning member comprising an elongate member including proximal and distal ends, a housing on the proximal end, and an expandable positioning element on the distal end; and

a cartridge advanceable along the positioning member from a proximal position adjacent the housing to a distal position, the cartridge comprising;

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

b) a sealant disposed within the tubular member lumen adjacent the tubular member distal end;

c) an advancer member disposed within the tubular member lumen for exposing the sealant distally from the tubular member lumen when the tubular member is retracted proximally relative to the advancer member; and

d) a sleeve slidably disposed over the tubular member distal end, at least a portion of the sleeve sized to abut the introducer sheath hub such that, when the tubular member is advanced from the proximal position to the distal position, the tubular member distal end enters the introducer sheath lumen through the hub while the sleeve is stopped by the introducer sheath hub and slides over the tubular member to expose the tubular member distal end within the introducer sheath lumen.

14. The apparatus of claim 13, wherein the sleeve comprises a distal portion sized to enter the introducer sheath hub when the cartridge is advanced towards the distal position and a proximal portion that abuts the introducer sheath hub to prevent the entire sleeve from entering the introducer sheath lumen.

15. The apparatus of claim 14, wherein the introducer sheath hub comprises a hemostatic valve therein, and wherein the sleeve distal portion at least partially opens the valve when the cartridge is advanced towards the distal position to facilitate the tubular member distal end entering the introducer sheath lumen.

16. The apparatus of claim 13, wherein the sealant is disposed within the tubular member adjacent the tubular member distal end, and wherein the tubular member comprises a slitted distal tip to facilitate exposure of the sealant from the tubular member distal end when the tubular member is retracted proximally after being advanced to the distal position.

17. The apparatus of claim 13, wherein the sleeve comprises an inner surface configured to provide different frictional interference with an outer surface of the tubular member to allow proximal movement and resist distal movement of the sleeve over the tubular member.

18. The apparatus of claim 13, wherein at least one of the positioning member and the cartridge comprise one or more features that limit distal movement of the tubular member when the cartridge is advanced from the proximal position to the distal position.

19. The apparatus of claim 18, wherein the one or more features are located to prevent further distal movement of the tubular member when the tubular member distal end is spaced a predetermined distance from the positioning element.

21. The apparatus of claim 13, further comprising cooperating elements on the advancer member and the positioning member that limit subsequent proximal movement of the advancer member relative to the positioning member after the cartridge is advanced to the distal position.

20. (canceled)

22-24. -24. (canceled)

25. A method for sealing a puncture extending through tissue to a body lumen, the puncture having an introducer sheath therein, comprising:

providing an elongate positioning member including proximal and distal ends, a cartridge slidable on the positioning member and carrying a sealant and an advancer member therein, and a slidable sleeve located over a distal end of the cartridge;

advancing the distal end of the positioning member through a lumen of the introducer sheath until a positioning element thereon is disposed within the body lumen;

advancing the cartridge over the positioning member until the sleeve on the cartridge contacts a proximal end of the introducer sheath;

further advancing the cartridge to a distal position such that the cartridge distal end enters the introducer sheath lumen while the sleeve is stopped by the introducer sheath, the sleeve sliding over the cartridge to expose the cartridge distal end within the introducer sheath lumen; and

retracting the introducer sheath and cartridge at least partially from the puncture, thereby exposing the sealant within the puncture distally beyond the introducer sheath.

26-34. -34. (canceled)