Craniotomy closures and plugs

• US 20070173844A1
• Filed: 01/17/2006
• Published: 07/26/2007
• Est. Priority Date: 01/17/2006
• Status: Active Grant

• Current Assignee: New Amsterdam LLC
• Original Assignee: Biodynamics LLC (GreenGro Technologies, Inc.)
• Inventors: Ralph, James, Troxell, Thomas
• Granted Patent: US 7,833,253 B2
• Time in Patent Office: Days
• US Class Current: 606/916
• CPC Class Codes: A61B 17/688 for reattaching pieces of the skull
• CPC Class Codes: Y10T 403/7176 Resilient clip

Abstract

Strip fasteners and cranial plugs for use in reattaching a skull flap removed during brain surgery and methods of using the same. The strip fasteners are flexible and can be shaped to follow the perimeter contour of the skull flap. The cranial plugs can be used to reattach the skull flap or they can be installed after the skull flap is reattached using the strip fasteners. In some embodiments, the cranial plug(s) and strip fasteners can be installed at the same time. The strip fasteners and cranial plugs are designed to encourage bone growth and healing of the skull flap and they can be used to deliver medication and bone growth enhancement compositions to the surgical site.

Claims

1. A strip fastener for reattaching a skull flap removed from a skull during brain surgery, the skull flap having a perimeter contour, comprising

a flexible strip which can be shaped to follow the perimeter contour of the skull flap, the strip having tabs or brackets with tabs, wherein at least one tab can be disposed over and adjacent to the skull flap and at least one other tab can be disposed over and adjacent to the skull.

2. The fastener of claim 1 wherein the strip has a length and one or more cavities disposed along the length.

3. The fastener of claim 2 having one cavity disposed along the entire length.

4. The fastener of claim 3 wherein a shape of the cavity taken in a section transverse to the length of the strip is the shape of a U, a V, a J or a W.

5. The fastener of claim 1 wherein the tabs or brackets with tabs are affixed to the flexible strip.

6. The fastener of claim 1 wherein the brackets with tabs are not affixed to the flexible strip.

7. The fastener of claim 1 wherein at least one tab can be affixed to the skull flap.

8. The fastener of claim 1 wherein the at least one other tab can be affixed to the skull.

9. The fastener of claim 1 wherein a sidewall of the strip can be affixed to the edge of either the skull or skull flap.

10. The fastener of claim 1 wherein the flexible strip can be shaped to follow all or a portion of the perimeter contour of the skull flap.

11. A strip fastener for reattaching a skull flap removed from a skull during brain surgery, the skull flap having a perimeter contour, comprising

a flexible strip which can be shaped to follow the perimeter contour of the skull flap, the strip having (i) an upper portion comprising tabs or brackets with tabs, wherein at least one tab can be disposed over and adjacent to the skull flap and at least one other tab can be disposed over and adjacent to the skull and (ii) a cavity extending downwardly from the upper portion, the cavity having at least one side portion and a bottom portion.

12. The fastener of claim 11 having openings disposed in the side portions.

13. The fastener of claim 12 wherein the openings are holes, slots or slits or a combination of two or more thereof.

14. The fastener of claim 11 wherein the shape of the cavity taken in a section transverse to the strip is the shape of a U, a V, a J or a W.

15. The fastener of claim 12 wherein the shape of the cavity taken in a section transverse to the strip is the shape of a U, a V, a J or a W.

16. The fastener of claim 11 wherein the cavity is comprised of multiple longitudinal pleats.

17. The fastener of claim 11 wherein the cavity is comprised of multiple lateral pleats.

18. A strip fastener for reattaching a skull flap removed from a skull during brain surgery, the skull flap having a perimeter contour, comprising

a flexible strip which can be shaped to follow the perimeter contour of the skull flap, the strip having (i) a top portion comprising tabs or brackets with tabs, wherein at least one tab can be disposed over and adjacent to the skull flap and at least one other tab can be disposed over and adjacent to the skull and (ii) a bottom portion having at least one tube disposed longitudinally thereon.

19. The fastener of claim 18 having more than one tube disposed longitudinally on the bottom portion.

20. A cranial plug for a burr hole or a cranial perforation-made in a skull during brain surgery, the burr hole or cranial perforation having side walls, comprising a flange having an upper surface, a lower surface and a central axis generally perpendicular to the upper surface, and at least one extension projecting downwardly and away from the lower surface, wherein said at least one extension is beside the side walls when the cranial plug is implanted in a patient.

21. The cranial plug of claim 20 further comprising means of affixing the flange to the skull flap and/or skull.

22. The cranial plug of claim 20 wherein said at least one extension is beside and in contact with the side walls of the burr hole or cranial perforation.

23. The cranial plug of claim 20 having at least one opening disposed in said at least one extension.

24. The cranial plug of claim 20 having at least one opening disposed in the flange and extending from the upper surface to the lower surface.

25. The cranial plug of claim 20 wherein said at least one extension comprises a plurality of flexible legs terminating at distal ends disposed away from the lower surface.

26. The cranial plug of claim 25 wherein each leg has a foot at the distal end extending outwardly and away from the central axis.

27. The cranial plug of claim 20 wherein said at least one extension comprises a plurality of flexible legs arranged radially about the central axis and equidistant therefrom and terminating at distal ends disposed away from the lower surface, further comprising a circular opening disposed in the flange coaxially with the central axis and a ring or a disc sized to fit through said circular opening, the ring or disc being movable to a position at or near the distal ends whereby the ring or disc causes the distal ends to be pushed outwardly and away from the central axis.

28. The cranial plug of claim 26 further comprising an opening disposed in the flange over each foot.

29. The cranial plug of claim 20 wherein said at least one extension comprises two flexible arcuate walls disposed opposite one another, the arcuate walls having distal ends disposed away from the lower surface and proximal ends affixed to the lower surface, the distal ends being connected with a bottom portion and the bottom portion being generally parallel with the lower surface, and the flange being cut into two pieces generally across a diameter disposed between the proximal ends of the arcuate walls.

30. The cranial plug of claim 29 wherein the arcuate walls have outer surfaces with barbs disposed thereon.

31. The cranial plug of claim 20 wherein said at least one extension comprises two flexible arcuate walls disposed opposite one another, the arcuate walls having outer surfaces with barbs disposed thereon.

32. The cranial plug of claim 20 wherein said at least one extension is frustoconical and has a central axis which is coaxial with the central axis of the flange, the frustoconical extension having an axially fluted outer surface which tapers inwardly toward the central axis as the extension projects downwardly and away from the lower surface toward a distal end of the frustoconical extension.

33. The cranial plug of claim 32 further comprising an opening extending from the upper surface, through the plug to the distal end of the frustoconical extension.

34. The cranial plug of claim 33 wherein the frustoconical extension is hollow.

35. The cranial plug of claim 34 wherein the outer surface of the frustoconical section has holes, slits or slots therethrough.

36. The cranial plug of claim 26 further comprising a circular opening in the flange arranged coaxially with the central axis, an axially moveable inner element having an upper surface and a removable stem projecting upwardly therefrom, the inner element and stem having a central axis which is coaxial with the central axis of the flange wherein the stem can be pulled upwardly through the circular opening until the upper surface of the inner element is adjacent the lower surface of the flange whereby the inner element causes the legs to move outwardly and press against the side walls.

37. The cranial plug of claim 20 wherein said at least one extension is frustoconical, has a central axis which is coaxial with the central axis of the flange and has an outer surface which tapers inwardly toward the central axis as the extension projects downwardly and away from the lower surface, further comprising at lease one flexible circular vane projecting outwardly from the outer surface in a plane in parallel with the lower surface.

38. The cranial plug of claim 20 wherein said at least one extension is a threaded cylinder having a central axis which is coaxial with the central axis of the flange and the upper surface has a drive opening to facilitate rotating the plug about the central axis.

39. The cranial plug of claim 38 wherein the drive opening is selected from the group consisting of cruciform, hex and spanner.

40. The cranial plug of claim 20 wherein said at least one extension comprises a plurality of flexible legs arranged radially about the central axis and equidistant therefrom and terminating at distal ends disposed away from the lower surface, further comprising a cam rotatable around the central axis and in contact with the legs whereby the cam can be rotated to cause the flexible legs to be pushed outwardly and away from the central axis.

41. The cranial plug of claim 20 wherein said at least one extension is comprised of multiple vanes which taper inwardly toward the central axis as the vanes project downwardly and away from the lower surface toward their distal ends, the flange optionally having an opening therethrough.

42. The cranial plug of claim 41 wherein the distal ends are affixed to a disc lying in a plane parallel to the plane of the lower surface and having a circumference defined by the circumference of a circle connecting the distal ends, the flange optionally having an opening therethrough.

43. The cranial plug of claim 20 having multiple extensions projecting downwardly and away from the lower surface and a central opening in the flange concentric with the central axis, the multiple extensions being disposed radially around the central opening, each extension having a proximal end affixed to the lower surface and being first tapered away from the central axis toward an elbow and then beginning at the elbow, being tapered toward the central axis until terminating at the distal end.

44. The cranial plug of claim 43 wherein each extension has a second elbow at the distal end whereupon the extension is tapered toward the central opening as it approaches the central axis.

45. The cranial plug of claim 43 further comprising a hinged cover for the central opening.

46. The cranial plug of claim 44 further comprising a hinged cover for the central opening.

47. A cranial plug for a burr hole or a cranial perforation made in a skull during brain surgery to facilitate cutting a skull flap out of the skull, the burr hole or cranial perforation having side walls, comprising a flexible strip which can be shaped to follow the contour of the side walls, the strip having upper tabs which can be affixed to the skull and the skull flap and lower tabs which form a barrier when the plug is implanted in the burr hole or cranial perforation.

48. A cranial plug for a burr hole or a cranial perforation made in a skull during brain surgery to facilitate cutting a skull flap out of the skull, the plug having a cup shaped portion with sides, a bottom and an upper rim, the sides optionally having holes, slits or slots disposed therein and the rim having outwardly disposed tabs which can be affixed to the skull and the skull flap and the bottom forms a barrier when the plug is implanted in the burr hole or cranial perforation.

49. A fastener system for reattaching a skull flap removed from a skull during brain surgery and for closing at least one burr hole or cranial perforation made in the skull to facilitate cutting out a skull flap, the skull flap having a perimeter contour and the burr hole or cranial perforation having side walls, comprising at least one flexible strip which can be shaped to follow the perimeter contour of the skull flap, the strip having tabs or brackets with tabs, wherein at least one tab can be disposed over and adjacent to the skull flap and at least one other tab can be disposed over and adjacent to the skull and at least one cranial plug comprising a flange having an upper surface, a lower surface and a central axis generally perpendicular to the upper surface, and at least one extension projecting downwardly and away from the lower surface, wherein said at least one extension is beside the side walls when the cranial plug is implanted in a patient.

50. A method of reattaching to a skull a skull flap removed from the skull to make an opening in the skull during brain surgery, the skull flap having a perimeter contour, comprising

shaping a strip fastener to follow the perimeter contour of the skull flap, the strip fastener comprising a flexible strip having tabs or brackets with tabs, wherein at least one tab can be disposed over and adjacent to the skull flap and at least one other tab can be disposed over and adjacent to the skull,

affixing the strip fastener to the skull flap,

positioning the skull flap with the strip fastener affixed thereto in the opening in the skull and in the position from which the skull flap was removed,

51. The method of claim 50 further comprising the step of affixing the strip fastener to the skull, thereby affixing the skull flap to the skull.

52. The method of claim 50 wherein at least one perforation or burr hole is made in the skull to make the opening in the skull.

53. The method of claim 52 wherein a cranial plug is installed in each perforation or burr hole.

54. The method of claim 52 wherein the there are at least two perforations or burr holes and the skull flap has a perimeter contour defined along each edge of the skull flap separating adjacent perforations or burr holes.

55. The method of claim 54 wherein a strip fastener is affixed to each perimeter contour.

56. The method of claim 55 wherein a cranial plug is installed in each cranial perforation or burr hole.

57. A method of reattaching to a skull a skull flap removed from the skull to make an opening in the skull during brain surgery and for closing at least one burr hole or cranial perforation made in the skull to facilitate cutting out the skull flap, the skull flap having a perimeter contour and the burr hole or cranial perforation having side walls, comprising

shaping a strip fastener to follow the perimeter contour of the skull flap, the strip fastener comprising a flexible strip having tabs or brackets with tabs, wherein at least one tab can be disposed over and adjacent to the skull flap and at least one other tab can be disposed over and adjacent to the skull,

affixing the strip fastener to the skull flap,

positioning the skull flap with the strip fastener affixed thereto in the opening in the skull and in a position from which the skull flap was removed,

affixing a cranial plug in at least one burr hole or cranial perforation.

58. The method of claim 57 wherein two or more burr holes or cranial perforations are made in the skull and a cranial plug is affixed in each of said burr holes or cranial perforations.

59. A method of reattaching to a skull a skull flap removed from the skull to make an opening in the skull during brain surgery and for closing at least one burr hole or cranial perforation made in the skull to facilitate cutting out the skull flap, the skull flap having a perimeter contour, comprising

positioning the skull flap in the opening in the skull and in a position from which the skull flap was removed,

affixing the skull flap to the skull by affixing a cranial plug in each burr hole.

60. The method of claim 59 further comprising shaping a strip fastener to follow the perimeter contour of the skull flap and affixing the strip fastener to the skull flap and the skull.

61. A method of reattaching to a skull a skull flap removed from the skull to make an opening in the skull during brain surgery and for closing burr holes or cranial perforations made in the skull to facilitate cutting out the skull flap, the skull flap having a perimeter contour and portions of the burr holes or cranial perforations, comprising

affixing a cranial plug to each portion of the burr holes or cranial perforations of the skull flap,

positioning the skull flap in the opening in the skull and in a position from which the skull flap was removed,

affixing the skull flap to the skull by affixing each cranial plug to the skull.

62. The method of claim 61 further comprising shaping a strip fastener to follow the perimeter contour of the skull flap and affixing the strip fastener to the skull flap and the skull.

63. A method of reattaching to a skull a skull flap removed from the skull to make an opening in the skull during brain surgery and for closing at least one burr hole or cranial perforation made in the skull to facilitate cutting out the skull flap, the skull flap having a perimeter contour and the burr hole or cranial perforation having side walls, comprising

shaping to follow the perimeter contour of the skull flap a flexible strip of a fastener system comprising the flexible strip and a cranial plug, and positioning the cranial plug in a portion of a burr hole on the skull flap, affixing the flexible strip or the cranial plug to the skull flap, positioning the skull flap in the opening in the skull and in a position from which the skull flap was removed,

affixing the cranial plug in the burr hole or cranial perforation and affixing the flexible strip to the skull.

64. A strip fastener for reattaching a skull flap removed from a skull during brain surgery, the skull flap having a perimeter contour, comprising

a flexible strip which can be shaped to follow the perimeter contour of the skull flap, the strip having a length and one or more cavities disposed along the length.

65. The strip fastener of claim 64 having one cavity disposed along the entire length.

66. The strip fastener of claim 65 wherein a shape of the cavity taken in a section transverse to the length of the strip is the shape of a U, a V, a J or a W.

67. The strip fastener of claim 66 wherein the shape of the cavity taken in a section transverse to the length of the strip is the shape of a J and the fastener has at least one tab which can be disposed over and adjacent to the skull flap.

68. The strip fastener of claim 65 further comprising at least one auxiliary fastener having an elongate flange which can be disposed over and adjacent to the skull flap and the skull and a tab extending downwardly from a lower surface thereof, the tab being shaped to fit within said one or more cavities and being secured to said one or more cavities.

69. An auxiliary fastener for securing a strip fastener used to reattach a skull flap removed from a skull during brain surgery, the strip fastener having a cavity, the auxiliary fastener comprising an elongate flange which can be disposed over and adjacent to the skull flap and the skull and a tab extending downwardly from a lower surface thereof, the tab being shaped to fit within the cavity and being secured to the cavity.