Expandable bioabsorbable plug apparatus and method

• US 8,758,399 B2
• Filed: 08/02/2010
• Issued: 06/24/2014
• Est. Priority Date: 08/02/2010
• Status: Expired due to Fees

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Fortson, Aaron M., McCoy, Jill A., Ziobro, John M., Voss, Laveille Kao, McCrystle, Kelly J.
• Primary Examiner(s): Bui, Vy Q
• Application Number:
  US12/848,642
• Publication Number:
  US 20120029555A1
• Time in Patent Office: 1,422 Days
• Field of Search: 606/213, 606/219, 606/142, 606/148, 606/144, 606/95, 623/1.13, 623/23.64
• 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 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• 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

Abstract

An apparatus for occluding a venous or arterial puncture site is disclosed including a plug insertable within, or adjacent to, a puncture site in a wall of a body lumen. An insert is forced into an aperture within the plug to cause expansion thereof. The insert may be drawn into the aperture by applying tension to a line passing therethrough and secured to the insert. Barbs may secure to the plug to engage the wall of the body lumen or adjacent tissue tract. Elongate members passing through the wall of the plug may be forced outwardly into the wall of the body lumen or adjacent tissue as the insert is forced into the aperture.

Claims

1. An apparatus for filling an opening in a wall of a body lumen comprising:

a plug formed of a bioabsorbable material and defining an inner aperture extending through the plug from an upper surface to a lower surface thereof, the inner aperture having a plug engagement surface, the plug including a plurality of channels extending from an exterior surface of the plug, through a body of the plug, to the inner aperture;

a plurality of elongate members each extending slidably through a channel of the plurality of channels of the plug and selectively projecting into the inner aperture; and

an insert formed of a bioabsorbable material configured to be slidably received within the inner aperture, the insert having a first insert engagement surface configured to contact the plug engagement surface, the plug engagement surface having an undeformed inner diameter less than an undeformed outer diameter of the first insert engagement surface, and having a second insert engagement surface configured to contact the plurality of elongate members and urge the plurality of elongate members to extend outward and away from the plurality of channels of the plug and out of the inner aperture.

2. The apparatus of claim 1, wherein each elongate member extends through the plug from adjacent the insert and projects outwardly from the plug.

3. The apparatus of claim 1, further comprising a plurality of projections secured to the plug proximate the lower surface and extending toward the upper surface.

4. The apparatus of claim 3, wherein the plurality of projections are barbs having a wide end thereof secured to the plug proximate the lower surface.

5. The apparatus of claim 1, wherein the plug defines a plurality of slits extending upwardly from the lower surface a portion of a distance between the upper and lower surfaces.

6. The apparatus of claim 1, wherein the insert and the aperture are tapered.

7. The apparatus of claim 1, wherein the insert is spherical.

8. The apparatus of claim 1, wherein the insert comprises a cylindrical portion having at least one tapered end portion.

9. The apparatus of claim 1, wherein the plug further comprises at least one stop projecting into the aperture, the insert positioned abutting the stop.

10. The apparatus of claim 1, wherein the bioabsorbable material is chitosan.

11. An apparatus for filling an opening in a wall of a body lumen comprising:

a plug formed of a bioabsorbable material and defining an inner aperture extending through the plug from an upper surface to a lower surface thereof and a plurality of channels extending from an exterior surface of the plug, through a body of the plug, to the inner aperture; and

a plurality of elongate members each extending slidably through a channel of the plurality of channels of the plug, the plurality of elongate members having a first position selectively projecting into the inner aperture and having a second position selectively projecting out and away from the plug and out of the inner aperture; and

an insert configured to be slidably received within the inner aperture, wherein the insert is configured to move the plurality of elongate members from the first position to the second position.

12. The apparatus of claim 11, wherein the aperture defines a wide portion proximate the lower surface and a narrow portion proximate the upper surface.

13. The apparatus of claim 12, further comprising a tapered surface extending between the wide portion and the narrow portion.

14. The apparatus of claim 13, wherein the plurality of elongate members extend into the aperture through the tapered surface.

15. The apparatus of claim 14, wherein the plurality of elongate members extend toward the upper surface with distance from the aperture.

16. The apparatus of claim 11, further comprising a plurality of projections secured to the plug proximate the lower surface and extending toward the upper surface.

17. The apparatus of claim 16, wherein the projections are barbs secured at a wide end thereof to the plug proximate the lower surface.

18. The apparatus of claim 11, wherein the plug defines a plurality of slits extending upwardly from the lower surface a portion of a distance between the upper and lower surfaces.

19. An assembly for filling an opening in a wall of a body lumen comprising:

a plug formed of a bioabsorbable material and defining an inner aperture extending through the plug from an upper surface to a lower surface thereof and a plurality of channels extending from an exterior surface of the plug, through a body of the plug, to the inner aperture, the aperture having a plug engagement surface;

a plurality of elongate members each extending slidably through a channel of the plurality of channels of the plug and selectively projecting into the inner aperture; and

an insert formed of a bioabsorbable material, the insert having an insert engagement surface positionable contacting the plug engagement surface; and

an actuating member engaging the insert and selectively movable to urge the inset engagement surface against the plug engagement surface and expand an outer diameter of the plug is expanded.

20. The assembly of claim 19, further comprising a rigid catheter;

wherein the actuating member is a tether extending through the catheter having the plug positioned between the insert and the catheter.

21. A method for filling an opening in a wall of a body lumen comprising:

inserting a plug including a bioabsorbable material into the opening, the plug defining an inner aperture extending through the plug from an upper surface to a lower surface thereof, the inner aperture having a plug engagement surface, the plug including a plurality of channels extending from an exterior surface of the plug, through a body of the plug, to the inner aperture, a plurality of elongate members each extending slidably through a channel of the plurality of channels of the plug and selectively projecting into the inner aperture; and

positioning an insert including a bioabsorbable material into the aperture, the insert being slidably received within the inner aperture, the insert having a first insert engagement surface contacting the plug engagement surface, the plug engagement surface having an undeformed inner diameter less than an undeformed outer diameter of the first insert engagement surface, and having a second insert engagement surface configured to contact the plurality of elongate members and urge the plurality of elongate members to extend outward and away from the plurality of channels of the plug and out of the inner aperture, the insert having an outer diameter greater than an undeformed inner diameter of the aperture.

22. The method of claim 21, wherein the wall defines an inner and an outer surface;

and wherein inserting the plug into the opening comprises inserting the plug through the outer surface.

23. The method of claim 21, wherein positioning the insert in the aperture comprises passing the insert from outside the body lumen into the aperture.

24. The method of claim 23, wherein positioning the insert in the aperture comprises urging the insert into the aperture such that it abuts a stop projecting into the aperture.

25. The method of claim 21, wherein positioning the insert in the aperture comprises drawing the insert from inside the body lumen into the aperture.

26. The method of claim 25, wherein drawing the insert from inside the body lumen into the aperture comprises tensioning a tether secured to the insert and passing through the aperture.