Bone alignment and fixation device and installation method

• US 6,302,884 B1
• Filed: 09/25/2000
• Issued: 10/16/2001
• Est. Priority Date: 11/09/1999
• Status: Expired due to Fees

• Current Assignee: Bioplate, Inc.
• Original Assignee: Bioplate, Inc.
• Inventors: Wellisz, Tadeusz Z., Hohenstein, Eric V.
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US09/669,439
• Time in Patent Office: 386 Days
• Field of Search: 606/69, 606/70, 606/72, 606/75, 606/86, 606/104, 606/151, 292/435.6, 411/61, 411/508
• US Class Current: 606/86.00B
• CPC Class Codes: A61B 17/688 for reattaching pieces of the skull
• CPC Class Codes: Y10S 606/903 Cranial and facial plate
• CPC Class Codes: Y10S 606/916 Tool for installing or removing orthopedic fastener

Abstract

This invention concerns a device, and instruments for its insertion, that aligns two sections of bone and fixates the two sections to one another. The alignment feature and the fixation feature are typically independent, but they are incorporated into one device. The device is particularly well adapted to the alignment and fixation of a fragment of cranial bone with the remainder of the cranium. The device can be applied to a cranial bone fragment, and it allows the bone fragment to be aligned with the outer cortex of the cranium; prevents the bone fragment from entering the cranial cavity; and if desired, fixates the bone fragment to the cranium. The device may take the form of a clip having a tab to surface engage one section of bone, two projections to respectively engage edge portions of two bone sections, and an S-shaped flange integral with the tab and at least one of the projections.

Claims

1. A clip to inter-connect primary and secondary bone zones having edges, comprising in combination:

a) a tab to extend over and generally parallel to a surface of the secondary bone zone, and above a first level defined by that surface, and

b) a first projection configured to penetrate the primary bone zone at the edge thereof, and below said first level,

c) there being an extension of the tab projecting below said first level, said extension carrying the first projection,

d) said extension including a movable arcuate arm portion.

2. The combination of claim 1 including an extension of the tab projecting below said first level, said extension carrying the first projection.

3. The combination of claim 2 including a second projection carried by the tab and configured to engage the secondary bone zone at the edge thereof, and below said surface level.

4. The combination of claim 3 wherein the second projection is carried by the tab extension.

5. The combination of claim 2 wherein said tab has the form of a plate that extends forwardly and downwardly to define said extension, said extension having S configuration, said first projection extending forwardly from a part of the tab extension below said level.

6. The combination of claim 1 wherein said first projection has a sharp terminal to enable penetration of bone marrow.

7. The combination of claim 3 wherein said first projection projects in a direction generally away from said second projection.

8. The combination of claim 4 wherein said second projection has a sharp terminal to enable penetration of diploe.

9. The combination of claim 5 wherein said second projection extends at an acute angle relative to a rearwardly convex portion of said S-configuration extension, and toward said tab.

10. The combination of claim 2 including at least one of the following:

i) a through hole in the tab to receive a fastener, and ii) a through hole in the extension, to receive a fastener.

11. The combination of claim 3 including another second projection carried by the tab in sidewardly spaced relation to the first mentioned second projection, and configured to engage the secondary bone zone at the edge thereof, and below said level.

12. The combination of claim 11 wherein each said second projection has a sharp terminal to enable penetration of bone tissue, said sharp terminals being relatively divergent.

13. The combination of claim 12 wherein each second projection extends back upwardly at an acute angle toward the tab.

14. The combination of claim 3 including said primary bone zone penetrated by a tip of said first projection, and said secondary bone zone engaged by a tip of said second projection.

15. The combination of claim 1 including a cranial bone flap defining said primary bone zone.

16. The combination of claim 15 including multiple of said clips having said first projections penetrating the primary bone zone below a surface defined by the flap.

17. The combination of claim 3 wherein said second projection includes a barb.

18. The combination of claim 17 wherein there are two of said barbs angled upwardly, and located on zones defined by said tab extension, said zones projecting laterally oppositely relative to said first projection.

19. The combination of claim 18 including attachment wings defined by said extension.

20. The combination of claim 1 including a bowed flange integral with the tab.

21. The combination of claim 20 wherein the flange has sections at least one of which is bowed.

22. The combination of claim 21 wherein one of the sections is integral with the tab and the other of the sections is integral with the projection.

23. The combination of claim 22 wherein the first projection extends generally forwardly, and said one section is bowed in said forward direction.

24. The combination of claim 21 wherein the flange has S-configuration.

25. The combination of claim 1 including an S-configuration flange integral with the tab.

26. The combination of claim 25 wherein the flange is also integral with the first projection.

27. The combination of claim 25 including a second projection integral with the S-configuration flange and configured to engage the secondary bone zone at the edge thereof, and below said surface level.

28. The combination of claim 27 wherein the first projection has a sharp terminal to enable penetration of bone marrow, the first projection projecting in a direction generally away from the second projection.

29. The combination of claim 27 wherein said second projection extends generally away from the first projection and is carried by a bowed portion of said S-configuration flange.

30. The combination of claim 27 including another second projection carried by the tab in sidewardly spaced relation to the first mentioned second projection, and configured to engage the secondary bone zone at the edge thereof, and below said level.

31. The combination of claim 30 wherein each said second projection has a sharp terminal to enable penetration of bone tissue, said sharp terminals being relatively divergent.

32. The combination of claim 27 including said primary bone zone penetrated by a tip of said first projection, and said secondary bone zone engaged by a tip of said second projection.

33. The combination of claim 25 including a cranial bone flap defining said primary bone zone.

34. The combination of claim 33 including multiple of said clips having said first projections penetrating the primary bone zone below a surface defined by the flap.

35. The combination of claim 1 wherein the clip consists essentially of one of the following:

i) titanium

ii) titanium alloy

iii) an alloy consisting essentially of titanium, aluminum and vanadium

iv) an alloy consisting essentially of;

about 90% by weight of titanium

about 6% by weight of aluminum

about 4% by weight of vanadium.

36. The combination of claim 2 wherein said tab includes an arm portion extending in the direction of said projection, and carrying said extension of the tab that projects below said first level.

52. The combination of claim 7 wherein the first projection has barbs thereon spaced apart in said directions.

37. The method of using a clip to interconnect primary and secondary bone zones having edges, the clip comprising

a) a tab to extend over and generally parallel to a surface of the secondary bone zone, and above a level defined by that surface, and

b) a first projection carried by the tab and configured to penetrate the primary bone zone at the edge thereof, and below said first level, said method including the steps

i) advancing the first projection to penetrate said primary bone zone,

ii) and locating the tab to extend over said surface of the secondary bone zone, and attaching the tab to said surfaces

c) there being an extension of the tab projecting below said first level, said extension carrying the first projection,

d) said extension including a movable arcuate arm portion.

38. The method of claim 37 including a second projection carried by the tab and configured to engage the secondary bone zone at the edge thereof, and below said surface level, the method including displacing the clip and said second projection to engage the secondary bone zone at the edge thereof, below said surface level.

39. The method of claim 37 wherein said step i) includes pushing the clip toward said primary bone zone to effect push-in penetration of the first projection into said primary bone zone.

40. The method of claim 39 including orienting the second projection at the edge of the secondary bone zone to resist reverse displacement of the clip in an upward or opposite direction relative to the secondary bone zone.

41. The method of claim 40 including effecting penetration of the edge of the secondary bone zone by the second projection in an angular direction toward the tab.

42. The method of claim 37 including providing an S-configuration flange integral with the tab.

43. The method of claim 42 including providing a second projection integral with the S-configuration flange and configured to engage the secondary bone zone at the edge thereof, and below said surface level.

44. The method of claim 42 wherein said step i) includes pushing the clip toward said primary bone zone to effect push-in penetration of the first projection into said primary bone zone.

45. The method of claim 42 including orienting the second projection at the edge of the secondary bone zone to resist reverse displacement of the clip in an upward or opposite direction relative to the secondary bone zone.

46. The method of claim 45 including effecting penetration of the edge of the secondary bone zone by the second projection in an angular direction toward the tab.

47. A cranial clip comprising, in combination

a) a clip having a support plate,

b) a flange integral with the plate and extending away from the plate, the flange having bowed configuration,

c) at least one push-in tang integral with and protruding from the flange and extending generally parallel to the plate, in spaced relation to the plate,

d) said tang having a sharp tip to be pushed into cranial soft bone tissue proximate an edge of the cranium,

e) there being an extension of the flange projecting below said first level, said extension carrying the first projection,

f) said extension including a movable arcuate portion.

48. The combination of claim 47 including an installation tool removably interfitting the clip, for forwardly pushing and guiding the clip, as the tang penetrates said soft bone tissue.

49. The combination of claim 47 wherein the clip flange has at least one integral ring, and an aligner on the ring.

50. The combination of claim 48 wherein the tool has at least one alignment bar projecting forwardly at the level of the top plate, for guided engagement with the top of the skull.

51. A clip having a tab to surface engage one section of bone, two projections to respectively engage edge portions of two bone sections, and an S-shaped flange integral with the tab and at least one of the projections.

53. A clip to inter-connect primary and secondary bone zones having edges, comprising in combination:

a) a tab to extend over and generally parallel to a surface of the secondary bone zone, and above a first level defined by that surface,

b) a first projection carried by the tab and configured to penetrate the primary bone zone at the edge thereof, and below said first level,

c) and including an extension of the tab projecting below said first level, said extension carrying the first projection,

d) and wherein said extension has an arm movable relative to the tab, the first projection carried by that arm.

54. The combination of claim 53 including a second projection carried by the tab and configured to engage the secondary bone zone at the edge thereof, and below said surface.

55. The combination of claim 54 wherein the second projection is carried by a part of the extension, relative to which the arm is movable.

56. The combination of claim 53 wherein the arm has S-configuration.

57. Apparatus to prevent a bone fragment from entering the cranial cavity, during positioning of said fragment at an opening in the cranium, comprising

a) a carrier for the bone fragment, and

b) an aligner on the carrier to engage a surface or surfaces of the cranium during positioning of the bone fragment relative to said cranial opening,

c) the carrier including:

i) a tab to extend over and generally parallel to a surface of the cranium, and above a first level defined by that surface, and

ii) a first projection configured to penetrate the cranium at the edge thereof, and below said first level,

iii) there being an extension of the tab projecting below said first level, said extension carrying the first projection,

iii) said extension including a movable arcuate arm portion.

58. The apparatus of claim 57 wherein the aligner has left and right slide surfaces to engage the cranial outer surface, as the aligner and bone fragment are moved forwardly.