U.S. patent application number 11/437490 was filed with the patent office on 2006-11-16 for cranial bone flap fixation system and method.
Invention is credited to Cin K. Abidin, Dean Gray, Tadeusz Z. Wellisz.
Application Number | 20060259040 11/437490 |
Document ID | / |
Family ID | 37420136 |
Filed Date | 2006-11-16 |
United States Patent
Application |
20060259040 |
Kind Code |
A1 |
Wellisz; Tadeusz Z. ; et
al. |
November 16, 2006 |
Cranial bone flap fixation system and method
Abstract
A cranial bone and bone flap fixation device, comprising first
and second caps between which portions of the cranial bone and bone
flap are to be gripped; a mounting post located to allow relative
cap movement lengthwise of an axis defined by the post, at least
the first cap, which is movable lengthwise of the post, forming
peripheral petals that are spaced apart about an axis and radially
outwardly of a central body portion of the cap, whereby the petals
are individually and resiliently movable relative to the central
body portion in directions generally parallel to the axis, and in
response to gripping.
Inventors: |
Wellisz; Tadeusz Z.; (Los
Angeles, CA) ; Abidin; Cin K.; (Los Angeles, CA)
; Gray; Dean; (Los Angeles, CA) |
Correspondence
Address: |
WILLIAM W. HAEFLIGER
201 S. LAKE AVE
SUITE 512
PASADENA
CA
91101
US
|
Family ID: |
37420136 |
Appl. No.: |
11/437490 |
Filed: |
May 19, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10171555 |
Jun 11, 2002 |
7048737 |
|
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11437490 |
May 19, 2006 |
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Current U.S.
Class: |
606/916 ;
606/324; 606/331; 606/907 |
Current CPC
Class: |
A61B 17/88 20130101;
A61B 17/688 20130101 |
Class at
Publication: |
606/072 |
International
Class: |
A61B 17/58 20060101
A61B017/58 |
Claims
1. A cranial bone and bone flap fixation device, comprising a)
first and second caps between which portions of the cranial bone
and bone flap are to be gripped, b) a mounting post located to
allow relative cap movement lengthwise of an axis defined by the
post, c) at least the first cap forming peripheral petals that are
spaced apart about said axis and radially outwardly of a central
body portion of the cap, whereby the petals are individually and
resiliently movable relative to said central body portion in
directions generally parallel to said axis, and in response to said
gripping, said first cap being movable lengthwise of the post.
2. The device of claim 1 wherein said petals have widths which
decrease in directions toward said axis to define flexure zones
spaced between said axis and portions of the petals furthest from
said axis.
3. The device of claim 1 wherein said petals have flexure zones
spaced between said axis and portions of the petals furthest from
said axis.
4. The device of claim 1 wherein said petals are one of the
following: i) metallic ii) non-metallic.
5. The device of claim 1 wherein said petals consist essentially of
titanium, titanium alloy, or other bio-compatible material.
6. The device of claim 1 wherein each of said first and second caps
has peripheral petals as defined in sub-paragraph c) of claim
1.
7. The device of claim 1 wherein one of the caps is attached to an
end of the post, and the other cap is adjustably movable along said
post toward said one cap, the petals of each cap having peripheral
portions angled toward the other cap.
8. The device of claim 7 wherein the post has axially spaced
retention shoulders, and the other cap has tabs spaced about and
projecting toward said axis, and which have ratcheting engagement
with said shoulders as said other cap is moved toward said one cap,
said retention shoulders angled to unidirectionally lock to the
tabs.
9. The device of claim 8 wherein said tabs are spaced about said
axis, and are individually resiliently flexible in directions
generally parallel to said axis.
10. The device of claim 8 wherein said tabs have widths less than
their lengths, and define tips that have said ratcheting engagement
with said shoulders.
11. The device of claim 8 wherein the number of said tabs is less
than the number of said petals.
12. A cranial bone and bone flap fixation device, comprising a)
first and second caps between which portions of the cranial bone
and bone flap are to be gripped, b) a mounting post located to
allow relative cap movement lengthwise of an axis defined by the
post, c) one of the caps being attached to an end of the post, the
other cap being movable along the post toward said one cap, d) the
post having axially spaced retention shoulders, and the other cap
has spaced tabs projecting toward said axis, and which have
ratcheting engagement with said shoulders as said other cap is
moved toward said one cap, said shoulders configured for blocking
retraction of said other cap lengthwise of the post.
13. The device of claim 12 wherein said tabs are spaced about said
axis, and are individually resiliently flexible in directions
generally parallel to said axis.
14. The device of claim 12 wherein said tabs have widths less than
their lengths, and define tips that have said ratcheting engagement
with said shoulders.
15. The method of affixing a bone flap to an adjacent cranial zone,
that includes a) providing first and second caps between which
portions of the cranial bone and bone flap are to be gripped, b)
providing a mounting post located to allow relative cap movement
lengthwise of an axis defined by the post, c) providing at least
the first cap with peripheral petals that are spaced apart about
said axis and radially outwardly of a central body portion of the
cap, whereby the petals are individually and resiliently movable
relative to said central body portion in directions generally
parallel to said axis, and in response to said gripping, d)
relatively displacing the caps toward one another to engage the
petals of one cap with at least the bone flap or the adjacent
cranial bone, and to conformingly retain the caps including said
petals to opposite sides of the flap and the cranial bone, e)
tightening the caps relatively toward one another into positions
wherein relative separation of the caps is blocked, petals are
resiliently flexed, and post extent between the caps is tensioned,
the lower cap pulled in an upward direction as the upper cap is
tightened downwardly.
16. The device of claim 1 including a protruding guide on at least
one of said caps and configured to extend into a gap formed between
the cranial bone and bone flap, to laterally orient the one cap so
that petal portions thereof will lap, to approximately equal
lateral extents, adjacent cranial bone and bone flap surfaces.
17. The device of claim 16 wherein said guide has an axially
tapering surface to project into the gap between edges of said
cranial bone and bone flap.
18. The device of claim 17 including a cover extending over a
cavity formed by said protruding guide, and attached to said one
cap.
19. The device of claim 16 wherein said guide has cup-shape.
20. The device of claim 16 wherein said protruding guide comprises
guide tabs that are bent to protrude into said gap, said tabs
spaced about said axis.
21. The device of claim 12 including a protruding guide on at least
one of said caps and configured to extend into a gap formed between
the cranial bone and bone flap, to laterally orient the one cap so
that petal portions thereof will lap to approximately equal lateral
extents adjacent cranial bone and bone flap.
22. The device of claim 21 wherein said guide has an axially
tapering surface or surfaces to project into the gap between edges
of said cranial bone and bone flap.
23. The device of claim 22 including a cover extending over a
cavity formed by said protruding guide, and attached to said one
cap.
24. The device of claim 21 wherein said protruding guide has
cup-shape.
25. The device of claim 21 wherein said protruding guide comprises
guide tabs that are bent to protrude into said gap, said tabs
spaced about said axis.
26. The method of claim 15 wherein at least one of the caps has a
protruding guide thereon, and including the step of causing said
guide to orient the cap transversely as the cap petals approach or
engage bone flap and cranial bone surfaces.
27. A cranial bone and bone flap fixation device, comprising a)
first and second caps between which portions of the cranial bone
and bone flap are to be gripped, b) a mounting post located to
allow relative cap movement lengthwise of an axis defined by the
post, c) and including a protruding guide on one of said caps and
configured to extend into a gap formed between the cranial bone and
bone flap, to laterally orient the one cap so that an outer portion
thereof will lap, to approximately equal lateral extent, adjacent
cranial bone and bone flap surfaces.
28. The device of claim 27 wherein said guide has an axially
tapering surface to project into the gap between edges of said
cranial bone and bone flap.
29. The device of claim 28 including a cover extending over a
cavity formed by said protruding guide, and attached to said one
cap.
30. The method of affixing a bone flap to an adjacent cranial zone,
that includes a) providing first and second caps between which
portions of the cranial bone and bone flap are to be gripped, b)
providing a mounting post located to allow relative cap movement
lengthwise of an axis defined by the post, c) relatively displacing
the caps toward one another to first engage one cap with the
underside of at least the bone flap or the adjacent cranial bone,
d) and then tightening the caps relatively toward one another into
positions wherein relative separation of the caps is blocked, the
lower cap pulled upwardly as the upper cap is tightened
downwardly.
31. The method of claim 30 including providing a protruding guide
on at least one of said caps and configured to extend into a gap
formed between the cranial bone and bone flap, to laterally orient
the one cap to have approximately equal lateral extents thereof
adjacent cranial bone and bone flap surfaces.
32. The method of claim 31 wherein said guide is provided with an
axially tapering surface to project into the gap between edges of
said cranial bone and bone flap.
Description
BACKGROUND OF THE INVENTION
[0001] This invention relates generally to cranial surgery
apparatus and method, and more particularly to implant systems and
methods for re-fixation of cranial bone flaps after craniotomy.
[0002] Cranial bone flaps after craniotomy are typically fixed in
position with wire, suture material or mini plates and screws. In
some cases, fixation with wire or suture material is not secure.
Shifting of the bone flap may result in dislocation, causing
depression or protrusion of the flap relative to the adjacent
cranium. This phenomenon occurs more frequently with the
progressive shift to smaller craniotomies for minimally invasive
surgical procedures.
[0003] Fixation of the bone flap using mini plates and screws has
improved the attachment of the bone flap. This technique, however,
demands a considerable amount of time and added cost. There is need
for an improved system for fixation of the bone flap to the
cranium, providing for quick and easy application, optimal
stability, and reliable fixation of the bone flap to the
cranium.
SUMMARY OF THE INVENTION
[0004] It is a major object of the invention to provide improved
flap fixation apparatus, system and methods meeting the above
needs. Basically, the fixation device of the invention
comprises:
[0005] a) first and second caps between which portions of the
cranial bone and bone flap are to be gripped,
[0006] b) a mounting post located to allow relative cap movement
lengthwise of an axis defined by the post,
[0007] c) at least the first cap forming peripheral petals that are
spaced apart about said axis and radially outwardly of a central
body portion of the cap, whereby the petals are individually and
resiliently movable relative to said central body portion in
directions generally parallel to the axis, and in response to such
gripping.
[0008] Another object includes provision of fixation petals at one
or both caps, and having widths which decrease in directions toward
the axis, to define flexure zones spaced between said axis and
portions of the petals furthest from said axis, whereby cap and
petal conformation to gripped flap and cranial elements is
enhanced. Typically, such petals may have flexible zones spaced
between the axis and portions of the petals furthest from said
axis. Further, one cap is typically attached to an end of the post,
and the other cap is adjustably movable along the post toward the
one cap, the petals of each cap having bone engaging peripheral
portions angled toward the space between the caps.
[0009] Another object is to provide a post having axially spaced
retention shoulders, the other cap having circularly spaced tabs
projecting generally toward said axis, and which have ratcheting
engagement with such shoulders as the other cap is moved toward the
one cap, the shoulders typically blocking retraction of said other
cap. Such tabs are typically spaced about the post axis, and are
individually resiliently flexible in directions generally parallel
to said axis.
[0010] A further object is to provide improved tabs having widths
less than their lengths, and that define tips that have said
ratcheting engagement with post shoulders. The number of such tabs
is typically less than the number of petals; and the number of
petals is such as to enable between two and four petals to engage
the bone flap, and two to four petals to engage the cranial
bone.
[0011] Yet another object includes a method of use of the device,
which includes:
[0012] a) relatively displacing the caps toward one another to
engage the petals of one cap with at least the bone flap or the
adjacent cranial zone, and to conformingly retain the caps
including said petals to opposite sides of the bone flap and the
cranial bone,
[0013] b) and tightening the caps toward one another into a
positions wherein relative separation of the caps is blocked,
petals are resiliently flexed, and post extent between the caps is
tensioned.
[0014] An additional object is to provide for cap self centering
functionality, as by provision of a cap guide configured to extend
into a gap formed between the cranial bone and bone flap, to
laterally orient the one cap so that petal portions thereof will
overlap the cranial bone and bone flap to approximately equal
lateral extents. That guide may have an axially tapering surface or
surfaces to project into the gap between edges of said cranial bone
and bone flap; and the guide may comprise a cup-shape or tapering
tabs, as will be seen. Both caps may incorporate such
self-centering functionality.
[0015] A further object comprises provision of a cover extending
over a cavity formed by the protruding guide, and attached to said
one cap.
[0016] These and other objects and advantages of the invention, as
well as the details of an illustrative embodiment, will be more
fully understood from the following specification and drawings, in
which:
DRAWING DESCRIPTION
[0017] FIG. 1 is a side elevation showing top and bottom caps, and
a post;
[0018] FIG. 2 is like FIG. 1, but the caps have been relatively
moved toward a bone flap and cranial bone;
[0019] FIG. 3 is a perspective view of the bottom cap seen in FIGS.
1 and 2;
[0020] FIG. 4 is an enlarged top plan view of the FIG. 3 cap;
[0021] FIG. 5 is a further enlarged section, taken on lines 5-5 of
FIG. 4;
[0022] FIG. 6 is a perspective view of the top or upper cap seen in
FIGS. 1 and 2;
[0023] FIG. 7 is a top plan view of the FIG. 6 cap;
[0024] FIG. 8 is an enlarged section taken on lines 8-8 of FIG.
7;
[0025] FIG. 9 is a further enlarged fragmentary section taken on
lines 9-9 of FIG. 8;
[0026] FIG. 10 is an enlarged section taken on lines 11-11 of FIG.
7;
[0027] FIG. 11 is a further enlarged fragmentary section taken on
lines 11-11 of FIG. 10;
[0028] FIG. 12 is a side elevation showing the post as seen in FIG.
2;
[0029] FIG. 13 is an enlarged fragmentary elevation taken on lines
13-13 of FIG. 12;
[0030] FIG. 14 is a top plan view of a modified bottom cap;
[0031] FIG. 15 is a section taken on lines 15-15 of FIG. 14;
[0032] FIG. 16 is a top plan view of a modified top or upper cap,
for use with the FIG. 14 cap, and a post as referred to;
[0033] FIG. 17 is a section taken on lines 17-17 of FIG. 16;
[0034] FIG. 18 is a perspective view of a system of upper and lower
caps, applied to a bone flap and to cranial bone, and bridging the
gap therebetween;
[0035] FIG. 19 is an enlarged section showing upper and lower caps
and a post, fixing a bone flap in position relative to cranial
bone;
[0036] FIG. 20 is a side elevation showing an applicator;
[0037] FIG. 21 is a view like FIG. 20 showing the applicator
holding a post and upper and lower supported caps;
[0038] FIG. 22 is a perspective view showing another
applicator;
[0039] FIG. 23 is a side elevation view of the FIG. 22
applicator;
[0040] FIG. 24 is a top plan view of the applicator taken on lines
24-24 of FIG. 23;
[0041] FIG. 25 is a bottom plan view taken on lines 25-25 of FIG.
23;
[0042] FIG. 26 is an enlarged view taken on lines 26-26 of FIG.
25;
[0043] FIG. 27 is an enlarged fragmentary section taken on lines
27-27 of FIG. 25;
[0044] FIG. 28 is a schematic view showing force application,
ratcheting action, and relative displacement of the two caps,
during use of the device;
[0045] FIGS. 28a-28c are schematic showings of cap
installation;
[0046] FIG. 29 is a perspective view of a modification;
[0047] FIG. 30 is an elevational view of the FIG. 29 device;
[0048] FIG. 31 is a top plan view of the upper cap as also seen in
FIGS. 29 and 30;
[0049] FIG. 32 is a section taken on lines 32-32 of FIG. 31;
[0050] FIG. 33 is a perspective view of a further modified form of
the device;
[0051] FIG. 34 is an elevation taken in section through the device
of FIG. 33 during application to cranial bone and flap elements;
and
[0052] FIG. 35 is a perspective view of yet another modified form
of the device.
DETAILED DESCRIPTION
[0053] In FIG. 1 the cranial bone and bone flap fixation device 10
comprises first and second caps 11 and 12 between which portions of
cranial bone and bone flap are to be gripped. A mounting post 13 is
located to allow relative cap movement lengthwise of an axis 14
defined by the post. FIG. 2 shows the caps after such relative
movement toward one another, to close toward and against upper and
lower, or opposite surfaces 15a and 15b of cranial bone 15, and
against upper and lower, or opposite, surfaces 16a and 16b of bone
flap 16. Typically, the lower end 13a of post 13 is attached to or
integral with the central region 12a of cap 12, and projects
through kerf or gap 18 formed between 15 and 16 during surgery, and
through cap 11. The caps are urged toward one another while in
engagement with surfaces 15a and 15b, 16a and 16b, as by upward
pulling of the post upper extent 13b and downward pushing of the
cap 11. See also FIG. 28.
[0054] Petals 20 and 21 on the caps thereby become resiliently
deflected, while individually and locally conforming to the bone
surfaces and their curvatures, at the points of petal engagement
with such surfaces. The use of such petals allows differential
bending deflection of the petals to accommodate to desired
conformance to bone surface local geometric variation, at such
points of engagement. The post 13 may be serrated as shown at 25 to
enable one-way ratcheting relative movement of cap 11 toward cap
12, and also to enable positive locking of cap 11 to the post (i.e.
shoulder angularity to block cap 11 retraction) after desired
forcible petal edge engagement of both caps with the bone and bone
flap 15 and 16, as will be further explained. After such locking,
the post is severed at region 13d close to the cap 11. Positive
locking of the cap 11 to the post assures positive retention of the
caps in engagement with upper and lower sides of the cranial bone
and bone flap, and resultant positive positioning of the flap in
position relative to cranial bone, during and after replacement of
the flap to the skull, promoting healing.
[0055] FIGS. 3-5 are views showing one preferred configuration of
the petals 20 on lower cap 12. They have widths which decrease in
directions toward the cap center region 27, to define narrowed
petal flexure zones 28 spaced between center region 27 and
peripheral portions 20a of the petals furthest from the center 27,
and from post axis 14.
[0056] The post is typically attached to the cap 12, at its center.
The petals have opposed widthwise spaced edges 20b and 20c, which
taper toward center region 27, as shown, increasing petal resilient
flexability at the narrowed width, flexure zones. FIGS. 4 and 5
show that the petals have outermost segments 20e with
bi-directional bending, or curvature, as in directions both about
axis 14, and also in axial radial planes, for example the plane of
FIG. 5, assuring gripping of bone by bent and stiffened petal
segment edges. See segment local upward bend at 20f, which also
provides an edge 20g for positive gripping of the bone or bone flap
material. Between 5 and 7 such segments is preferred, and 6 are
shown. Cap controlled stiffness is also enhanced by upward
deflection of the cap region 12d inwardly of gaps 30 formed between
the petals. The cap preferably consists of titanium (anodized so as
not to oxidize) or titanium alloy, or other bio-compatible
material. Cap thickness is typically between 0.010 and 0.015
inch.
[0057] FIGS. 6-11 are views showing one preferred configuration of
petals 35 on upper cap 11. They also have widths which decrease in
directions toward cap central region 36, to define flexure zones 37
located between the central region 36 and peripheral portions 35a
farthest from region 36, through which post axis 14 extends.
[0058] Petals 35 have opposed and widthwise spaced edges 35b and
35c, which relatively taper toward region 36, increasing petal
resilient flexability at the flexure like narrowed width zones.
FIGS. 7-10 show that the petals have outermost segments 35e with
bi-directional bending or curvature, as in directions both about
axis 14, and also in axial radial planes, for example the planes of
FIGS. 8-10. Note segment downwardly radiused bend at 35f in FIG.
11, which also provides an edge 35g for positive gripping of the
bone or flap material at surfaces 15a and 16a.
[0059] Cap controlled stiffness is also enhanced by downward
deflection of the cap region 12d inwardly of the gaps 40 formed
between the petals. Cap 11 also preferably consists of titanium
(anodized) or titanium alloy, or other bio-compatible material, and
its thickness is typically between 0.010 and 0.015 inches.
[0060] Of further importance is the provision of spaced tabs, as at
45, projecting toward and spaced apart about axis 14, so as to have
one-way ratcheting engagement of tab narrowed inner edges 45a with
the post serrations as the upper cap 11 is displaced along the post
relatively toward lower cap 12. The tabs are individually
resiliently flexible in directions generally parallel to axis 14,
and for that purpose they have narrowed width flexure zones 45b
located between edges 45a and the regions 45c of tab jointure with
the dished region 49 of the cap. See FIGS. 6, 7, 8 and 10. The tab
flexure zones 45b have widths less than the tab length, and the
tabs extend at angles a out of the transverse plane of dished
region 49, to further such ratcheting engagement with post
serrations, and to facilitate locking of the three tab edges 45a
into the valley or valleys between successive serrations on the
post, to hold the cap petals compressingly against the upper and
lower surfaces of the cranial bone and bone flap. The number of
tabs is typically less than the number of petals, on the upper cap.
Accordingly, an important configuration of the invention
comprises:
[0061] a) first and second caps between which portions of the
cranial bone and bone flap are to be gripped,
[0062] b) a mounting post located to allow relative cap movement
lengthwise of an axis defined by the post,
[0063] c) one of the caps being attached to an end of the post, the
other cap being movable along the post toward said one cap,
[0064] d) the post having axially spaced retention shoulders, and
the other cap has spaced tabs projecting toward said axis, and
which have one-way ratcheting engagement with such shoulders as
said other cap is moved toward the one cap. FIGS. 12 and 13 show
post serrations 150 and one-way ratchet shoulders 151.
[0065] Also, the method of affixing a bone flap to an adjacent
cranial bone includes the steps:
[0066] a) providing first and second caps between which portions of
the cranial bone and bone flap are to be gripped,
[0067] b) providing a mounting post located to allow relative cap
movement lengthwise of an axis defined by the post,
[0068] c) providing at least the first cap with peripheral petals
that are spaced apart about said axis and radially outwardly of a
central body portion of the cap, whereby the petals are
individually and resiliently movable relative to said central body
portion in directions generally parallel to said axis, and in
response to said gripping,
[0069] d) relatively displacing the caps toward one another to
engage the petals of one cap with at least the bone flap or the
adjacent cranial bone, and to conformingly retain the caps
including said petals to opposite sides of the flap and the cranial
zone,
[0070] e) tightening the caps relatively toward one another into
positions wherein relative separation of the caps is blocked,
petals are resiliently flexed, and post extent between the caps is
tensioned.
[0071] Typically, the lower cap is pulled upwardly, toward the
underside of the flap and cranial bone, while the upper cap is
lowered, to avoid damage to brain tissue.
[0072] FIG. 28 schematically shows a first member 60 or pusher
pushing downwardly on the upper cap 11, while a second member 61
holds or positions the post 13, acting to hold the lower cap 12 in
position at the undersides of the cranial bone and flap elements 15
and 16. During such downward travel of the upper cap 11 it ratchets
along the post serrations, and ultimately becomes tightened against
the upper surfaces of 15 and 16, causing petal flexing as referred
to. FIGS. 12 and 13 show details of post serrations 151, with
barb-like edges 152 tapered forwardly (downwardly).
[0073] In the example shown in FIGS. 28a-28c, initially the stem or
post 13 is positioned to extend through the gap 101 between flap
and cranial bone elements 15 and 16, with cap 11 at the upper side
of the gap, and cap 12 at the lower side of the gap. Next, and as
seen in FIG. 28b, upward force (for example manual force 210) is
exerted on the stem or post 13 to elevate lower cap 12 away from
the brain region 211 and against the lower sides of 15 and 16 (to
avoid brain damage) as by petal engagement as described. Such
upward force exertion is maintained, as the upper cap 11 is then
lowered by force exertion 212, to engage the lower cap petals
against the upper sides of 15 and 16. The shoulders or teeth on the
post are angled to block upward retraction of the lowered tabs 45
and upper cap 11, relative to the post.
[0074] FIGS. 14 and 15 show a modified lower cap 66 having six
petals 67 spaced apart about a center region 68, with reduced width
radial slits 69 between the petals. The latter have narrowed width
flexure zones 67a between inner terminals 69a of the slits. The
petals extend at acute angles .beta., between 15.degree. and
25.degree. relative to a transverse plane 70, throughout the petal
radial lengths.
[0075] FIGS. 16 and 17 illustrate a top or upper cap 72 to be used
with cap 66. Cap 72 has six petals 73 spaced apart about an axis 74
corresponding to a serrated post axis, such as axis 14 described
above. Note radial slits 75 separating the petals 73 and the petal
flexure zones 73a of reduced width between inner extents of the
slits. The petals extend at angles (about 30.degree.) outwardly and
downwardly relative to a transverse plane 76, normal to axis 74,
throughout or substantially throughout petal radial lengths. Four
ratcheting or locating tabs 77 are provided to extend angularly
upwardly and inwardly at angles (about 28.degree.) toward axis 74
as seen in FIGS. 16 and 17. The tabs are spaced apart by four gaps
80, and they taper toward inner tips 81 that engage and ratchet on
and over the post serrations, such ratcheting characterized by
resilient deflection of the tabs as tips 81 ride over the outer
edges of the post serrations. Also, the tips lock into the
serration valley corresponding to tightened positioning of the
upper and lower caps.
[0076] FIG. 18 shows emplacement of multiple like devices 100 of
the type seen in FIGS. 14-17, to extend across a gap or kerf 101
formed between cranial bone and bone flap elements 15 and 16.
Variable surface curvature of those bone elements, at the location
of devices 100 is accommodated by variable petal flexing, as
described above. See also FIG. 19.
[0077] FIGS. 20 and 21 show use of a hand manipulable applicator
110 having pusher and holder parts 60a and 61a corresponding to
parts 60 and 61 referred to in FIG. 28. Hand manipulable element
111 is connected with part 61a via a stem 111a; and hand
manipulable element 112 is connected with part 60a, so that when
elements 111 and 112 are squeezed toward one another, the upper cap
is relatively displaced toward the lower cap, and the caps are
tightened against upper and lower surfaces of the cranial bone and
bone flap. Typically, the lower cap is pulled upwardly toward and
against undersides of the flap and cranial bone, during upper cap
lowering. Afterwards, the post is severed, adjacent the top
surfaces of the upper cap, as seen at 13d in FIG. 19.
[0078] FIGS. 29-32 show a modified form of the invention, which is
preferred. The upper cap 110 has spaced petals 111 separated by
slots 112 that extend inwardly toward the axis of post 113. The
petals and slots are curved as seen in FIG. 32 to concavely face
toward the lower cap 130. Petal edge portions 114 are turned
downwardly so that edges 114a will grip the flap and cranial bone
surfaces. Narrowed petal flexure zones are formed at 111a, between
inner extents of the slots, allowing petal flexing to accommodate
edge engagement with variably curved bone surfaces.
[0079] A protruding guide 116 is formed on, or carried on, the
upper cap 110 and configured to extend or project into a gap or
kerf 117 formed between cranial bone 118 and bone flap 119, at the
time of installation. See FIG. 34. The cap is thereby laterally
oriented so that petal portions indicated at A and B in FIG. 32
will be caused to automatically lap, to approximately equal lateral
extents, the adjacent or sub-tended cranial bone and flap surfaces
118a and 119a, as a result of assembly. Note that the guide under
surface 116a is generally cup-shaped, or frusto-conical, to project
into the gap between edges 118b and 119b of the bone surfaces at
the gap upper mouth. Also note that the three post-engaging and
ratcheting tabs 120, like those described in FIGS. 6-9, are carried
by the bottom wall 121 of the cup-shaped guide, and a void or
cavity exists at 122 above the level of those tabs. FIGS. 33 and 34
show the provision of a cover 125 extending over that cavity at the
levels of petals, and attached to the cap. Such attachment may be
effected by finger-like clips 128 projecting downwardly from the
periphery of the cover plate 125a, to clip into the slots 112,
plate 125a then seating on the upper surfaces 111a of petals 111.
Such a cover promotes healing of scalp skin over the cap and cover,
at generally the same level. The cover is typically applied after
the caps are in place, gripping the bone surfaces.
[0080] The bottom cap 130 also has petals 131 like those of the
upper cap, but with up-turned segment edge portions 132, those edge
portions having bi-directional curvature, assuring edge gripping of
bone tissue. Slots 133 are formed between petals 131, with
configurations like slots 112, excepting that the petals and slots
face concavely upwardly. An upwardly protruding inverted cup-shaped
guide 133, like guide 116, is carried by lower cap 130 to function
(with self centering) in the same manner as guide 116. See FIG. 34.
The lower end 113e of post 113 is centrally attached to the end
wall 133a of the guide, and it projects upwardly whereby tabs 120
can ratchet along post serrations 139, as the two caps approach one
another.
[0081] FIG. 35 shows another embodiment of the cap orienting guide,
in the form of tabs 140 projecting axially upwardly and inwardly
toward the post 144 from the inner wall 141 of a lower cap 142. As
shown, there is one tab spaced between each petal 143 and the post
144. The tabs provide annularly spaced and tapered surfaces
engagable with the bone flap and cranial bone lower edges adjacent
kerf referred to in FIG. 32, to laterally orient the lower cap,
upon assembly. The upper cap 150 may have similar tabs to centrally
orient it relative to the kerf or gap, upon assembly, for
accurately positioning and retaining the flap, relative to the
cranial bone. The provision of flexing petals allows such flexing
and shifting as the caps engage bone surfaces, and as
self-centering of the caps occurs due to provision of the
guides.
[0082] FIGS. 22-27 show another type applicator 180, having a post
gripping pincers 181, and handles 182 and 183 to cover gripping
movement and release of the pincers.
* * * * *