Vascular sealing device with high surface area sealing plug

• US 8,075,589 B2
• Filed: 11/29/2006
• Issued: 12/13/2011
• Est. Priority Date: 12/03/2003
• Status: Active Grant

• Current Assignee: Terumo Puerto Rico, L.L.C. (Terumo Corporation)
• Original Assignee: St Jude Medical Puerto Rico LLC (Abbott Laboratories Incorporated)
• Inventors: Pipenhagen, Catherine A., Belhe, Kedar R., Roop, John Avi
• Primary Examiner(s): WOO, JULIAN W
• Application Number:
  US11/605,603
• Publication Number:
  US 20070073345A1
• Time in Patent Office: 1,840 Days
• Field of Search: 606/72, 606/95, 606/213, 606/232
• US Class Current: 606/232
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple

Abstract

An internal tissue puncture closure method and apparatus. The method and apparatus provide a folded sealing plug that provides more surface area than conventional plugs to more fully cover and seal an external situs of an internal tissue puncture. The folded sealing plug may have a weave pattern that tends to cause the sealing plug to corkscrew into the internal tissue puncture as it is compressed toward an anchor placed inside of the tissue puncture.

Claims

1. A method of closing a hole in a blood vessel, the method comprising:

moving a closure device through the hole and into the blood vessel, the closure device including an anchor and a sealing plug;

positioning the anchor adjacent to the hole inside the blood vessel;

positioning the sealing plug adjacent to the hole outside the blood vessel; and

compressing the sealing plug and the anchor to close the hole, wherein the sealing plug twists into a different shape as the sealing plug and the anchor are compressed.

2. The method of claim 1 wherein the hole is an arteriotomy.

3. The method of claim 1 wherein moving the closure device through the hole and into the blood vessel includes inserting the closure device through an insertion sheath.

4. The method of claim 1 wherein the anchor is against the middle of the sealing plug.

5. The method of claim 1 wherein the closure device includes a filament that extends through the anchor and the sealing plug, the method comprising tensioning the filament to compress the sealing plug and the anchor and thereby close the hole.

6. The method of claim 5 wherein the filament is threaded through the sealing plug and the anchor in a manner to facilitate twisting of the sealing plug as the filament is tensioned and the sealing plug and the anchor are compressed.

7. The method of claim 5 wherein the filament extends through a first plurality of holes in the sealing plug, through the anchor, and through a second plurality of holes in the sealing plug.

8. A method of closing a hole in a blood vessel, the method comprising:

moving a closure device through the hole and into the blood vessel, the closure device including a filament, an anchor, and a sealing plug, wherein the filament extends through a first plurality of holes in the sealing plug, through the anchor, and through a second plurality of holes in the sealing plug;

positioning the anchor adjacent to the hole inside the blood vessel;

positioning the sealing plug adjacent to the hole outside the blood vessel; and

tensioning the filament to compress the sealing plug and the anchor and thereby close the hole.

9. The method of claim 8 wherein the hole is an arteriotomy.

10. The method of claim 8 wherein the sealing plug includes a first portion and a second portion that are at least substantially symmetrical, the first portion including the first plurality of holes and the second portion including the second plurality of holes.

11. The method of claim 8 wherein each one of the first plurality of holes and the second plurality of holes forms a zigzag pattern.

12. A method of closing a hole in a blood vessel, the method comprising:

moving a closure device through the hole and into the blood vessel, the closure device including an anchor and a sealing plug;

positioning the anchor adjacent to the hole inside the blood vessel;

positioning the sealing plug adjacent to the hole outside the blood vessel; and

compressing the sealing plug and the anchor to close the hole, wherein the sealing plug corkscrews into a different shape as the sealing plug and the anchor are compressed.

13. The method of claim 12 wherein the hole is an arteriotomy.

14. The method of claim 12 wherein the closure device includes a filament that extends through the anchor and the sealing plug, the method comprising tensioning the filament to compress the sealing plug and the anchor and thereby close the hole.

15. A method of closing a hole in a blood vessel, the method comprising:

moving a closure device through the hole and into the blood vessel, the closure device including a filament, an anchor, and a sealing plug, wherein the filament extends through the sealing plug in a spiral weave configuration;

positioning the anchor adjacent to the hole inside the blood vessel;

positioning the sealing plug adjacent to the hole outside the blood vessel; and

compressing the sealing plug and the anchor to close the hole.

16. The method of claim 15 wherein the closure device includes a filament that extends through the anchor and the sealing plug, the method comprising tensioning the filament to compress the sealing plug and the anchor and thereby close the hole.

17. A method of closing a hole in a blood vessel, the method comprising:

moving a closure device through the hole and into the blood vessel, the closure device including a filament, an anchor, and a sealing plug, wherein the filament extends through a first hole in the sealing plug, through the anchor, and through a different second hole in the sealing plug, the anchor being positioned at least substantially in the middle of the sealing plug;

positioning the anchor adjacent to the hole inside the blood vessel;

positioning the sealing plug adjacent to the hole outside the blood vessel and in contact with an outer surface of the blood vessel; and

tensioning the filament to provide a corkscrew effect in the sealing plug as the filament is put into tension to compress the sealing plug and the anchor and thereby close the hole.

18. The method of claim 17 wherein the sealing plug includes a first portion and a second portion that are at least substantially symmetrical, the first portion including the first hole and the second portion including the second hole.

19. A method of closing a hole in a blood vessel, the method comprising:

moving a closure device through the hole and into the blood vessel, the closure device including an anchor and a sealing plug, wherein the sealing plug includes at least two separate U-shaped components;

positioning the anchor adjacent to the hole inside the blood vessel;

positioning the sealing plug adjacent to the hole outside the blood vessel and in contact with an outer surface of the blood vessel; and

compressing the sealing plug and the anchor to close the hole, wherein the U-shaped components are engaged with each other.

20. The method of claim 19 wherein the closure device includes a filament that extends through the anchor and through each of the at least two separate U-shaped components of the sealing plug, the method comprising tensioning the filament to compress the sealing plug and the anchor and thereby close the hole.

21. A method of closing a hole in a blood vessel, the method comprising:

moving a closure device through the hole and into the blood vessel, the closure device including an anchor and a sealing plug, wherein at least one of the following is true regarding the sealing plug;

(a) the sealing plug has a generally V-shape when the sealing plug is open, unfolded and arranged flat, (b) the sealing plug has a generally X-shaped cross section, or (c) the sealing plug is folded to have a generally S cross-section shape in a plane arranged perpendicular to a length dimension of the sealing plug when the sealing plug is positioned in the closure device in an undeployed configuration;

positioning the anchor adjacent to the hole inside the blood vessel;

positioning the sealing plug adjacent to the hole outside the blood vessel; and

compressing the sealing plug and the anchor to close the hole.

22. The method of claim 21 wherein the sealing plug twists as the sealing plug and the anchor are compressed.

23. The method of claim 21 wherein the sealing plug has a generally V-shape when the sealing plug is open.

24. The method of claim 21 wherein the sealing plug has a generally X-shaped cross section.

25. The method of claim 21 wherein the sealing plug is folded to have a generally S-shape when the sealing plug is positioned in the closure device in an undeployed configuration.

26. A method of closing a hole in a blood vessel, the method comprising:

moving a closure device through the hole and into the blood vessel, the closure device including an anchor and a sealing plug;

positioning the anchor adjacent to the hole inside the blood vessel;

positioning the sealing plug adjacent to the hole outside the blood vessel; and

compressing the sealing plug and the anchor to close the hole, wherein the sealing plug twists as the sealing plug and the anchor are compressed;

wherein the anchor is against the middle of the sealing plug.

27. The method of claim 26 wherein the hole is an arteriotomy.

28. The method of claim 26 wherein moving the closure device through the hole and into the blood vessel includes inserting the closure device through an insertion sheath.

29. A method of closing a hole in a blood vessel, the method comprising:

moving a closure device through the hole and into the blood vessel, the closure device including an anchor, a sealing plug, and a filament that extends through the anchor and the sealing plug;

positioning the anchor adjacent to the hole inside the blood vessel;

positioning the sealing plug adjacent to the hole outside the blood vessel;

compressing the sealing plug and the anchor to close the hole, wherein the sealing plug twists as the sealing plug and the anchor are compressed;

tensioning the filament to compress the sealing plug and the anchor and to close the hole.

30. The method of claim 29 wherein the filament is threaded through the sealing plug and the anchor in a manner to facilitate twisting of the sealing plug as the filament is tensioned and the sealing plug and the anchor are compressed.

31. The method of claim 29 wherein the filament extends through a first plurality of holes in the sealing plug, through the anchor, and through a second plurality of holes in the sealing plug.

32. A method of closing a hole in a blood vessel, the method comprising:

moving a closure device through the hole and into the blood vessel, the closure device including an anchor, a sealing plug, and a filament that extends through the anchor and the sealing plug;

positioning the anchor adjacent to the hole inside the blood vessel;

positioning the sealing plug adjacent to the hole outside the blood vessel;

compressing the sealing plug and the anchor to close the hole, wherein the sealing plug corkscrews as the sealing plug and the anchor are compressed;

tensioning the filament to compress the sealing plug and the anchor and thereby close the hole.

33. The method of claim 32 wherein the hole is an arteriotomy.

34. A method of closing a hole in a blood vessel, the method comprising:

moving a closure device through the hole and into the blood vessel, the closure device including a filament, an anchor, and a sealing plug, wherein the filament extends through a first hole in the sealing plug, through the anchor, and through a second hole in the sealing plug, the anchor being positioned at least substantially in the middle of the sealing plug;

positioning the anchor adjacent to the hole inside the blood vessel;

positioning the sealing plug adjacent to the hole outside the blood vessel;

tensioning the filament to compress the sealing plug and the anchor and thereby close the hole;

wherein the sealing plug twists as the filament is tensioned and the sealing plug and the anchor are compressed.

35. The method of claim 34 wherein the sealing plug includes a first portion and a second portion that are at least substantially symmetrical, the first portion including the first hole and the second portion including the second hole.

36. A method of closing a hole in a blood vessel, the method comprising:

moving a closure device through the hole and into the blood vessel, the closure device including an anchor and a sealing plug, wherein the sealing plug includes at least two separate components;

positioning the anchor adjacent to the hole inside the blood vessel;

positioning the sealing plug adjacent to the hole outside the blood vessel;

compressing the sealing plug and the anchor to close the hole;

wherein the at least two separate components include a first component having a U-shape and a second component having a U-shape, wherein the first component and the second component are positioned opposite each other.

37. The method of claim 36 wherein the closure device includes a filament that extends through the anchor and through each of the at least two separate components of the sealing plug, the method comprising tensioning the filament to compress the sealing plug and the anchor and thereby close the hole.

38. A method of closing a hole in a blood vessel, the method comprising:

moving a closure device through the hole and into the blood vessel, the closure device including an anchor and a sealing plug, wherein at least one of the following is true regarding the sealing plug;

(a) the sealing plug has a generally V-shape when the sealing plug is open, (b) the sealing plug has a generally X-shaped cross section, (c) the sealing plug is folded to have a generally S-shape when the sealing plug is positioned in the closure device in an undeployed configuration, or (d) the sealing plug is folded latitudinally to have a generally rectangular shape when the sealing plug is positioned in the closure device in an undeployed configuration;

positioning the anchor adjacent to the hole inside the blood vessel;

positioning the sealing plug adjacent to the hole outside the blood vessel;

compressing the sealing plug and the anchor to close the hole;

wherein the sealing plug twists as the sealing plug and the anchor are compressed.

39. The method of claim 38 wherein the sealing plug has a generally V-shape when the sealing plug is open.

40. A method of closing a hole in a blood vessel, the method comprising:

moving a closure device through the hole and into the blood vessel, the closure device including an anchor and a sealing plug;

positioning the anchor adjacent to the hole inside the blood vessel;

positioning the sealing plug adjacent to the hole outside the blood vessel; and

compressing the sealing plug and the anchor to close the hole;

wherein the sealing plug has a generally X-shaped cross section.

41. A method of closing a hole in a blood vessel, the method comprising:

moving a closure device through the hole and into the blood vessel, the closure device including an anchor and a sealing plug;

positioning the anchor adjacent to the hole inside the blood vessel;

positioning the sealing plug adjacent to the hole outside the blood vessel; and

compressing the sealing plug and the anchor to close the hole;

wherein the sealing plug is folded to have a generally S cross-sectional shape in a plane arranged perpendicular to a length dimension of the sealing plug when the sealing plug is positioned in the closure device in an undeployed configuration.