U.S. patent application number 17/510596 was filed with the patent office on 2022-02-10 for anchors for vertebral body.
This patent application is currently assigned to OrthoPediatrics Corp.. The applicant listed for this patent is OrthoPediatrics Corp.. Invention is credited to Matt Prygoski, Evangelos Tozakoglou.
Application Number | 20220039839 17/510596 |
Document ID | / |
Family ID | |
Filed Date | 2022-02-10 |
United States Patent
Application |
20220039839 |
Kind Code |
A1 |
Prygoski; Matt ; et
al. |
February 10, 2022 |
ANCHORS FOR VERTEBRAL BODY
Abstract
Implantable devices for dynamic interconnection between bones,
and especially between vertebrae. Some devices include tethering
heads that are independent of the bone connecting member (fastener,
plate, hook, loop). The devices provide for various types of
manipulation of a flexible connection such as a tether, such as by
providing an aperture through which the flexible connection is
passed and guided, or a post to which a loop of the flexible
connection can be attached, or a groove in which a loop of the
flexible connection can be placed.
Inventors: |
Prygoski; Matt; (North
Liberty, IN) ; Tozakoglou; Evangelos; (Warsaw,
IN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
OrthoPediatrics Corp. |
Warsaw |
IN |
US |
|
|
Assignee: |
OrthoPediatrics Corp.
Warsaw
IN
|
Appl. No.: |
17/510596 |
Filed: |
October 26, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16361967 |
Mar 22, 2019 |
11185353 |
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17510596 |
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62646600 |
Mar 22, 2018 |
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International
Class: |
A61B 17/70 20060101
A61B017/70 |
Claims
1. A member for tethered connection to a bone, comprising: a bone
connecting member adapted and configured for connection with a
bone; and a tethering head separate from said bone connecting
member, said tethering head including a passageway being adapted
and configured to accept therein a flexible tether, said tethering
head having a bone contacting surface; said tethering head being
adapted and configured for coupling to said bone connecting member;
wherein connection of said bone connecting member to a bone places
the bone contacting surface in contact with said bone.
2. The member of claim 1, wherein said tethering head has an outer
peripheral surface and an ear projecting from the outer surface,
and said passageway extends through the ear.
3. The member of claim 2, wherein said ear is a first ear and the
passageway is a first through passageway, and which further
includes a second ear projecting from the outer surface, the second
ear including a second through passageway adapted and configured to
accept therein a flexible tether.
4. The member of claim 3, wherein the first ear and second ear are
on opposing sides of said tethering head.
5. The member of claim 3, wherein the first and second passageways
are substantially parallel.
6. The member of claim 1, wherein said tethering head includes a
through aperture adapted and configured to receive therethrough
said bone connecting member.
7. The member of claim 6, wherein coupling of said bone connecting
member and said tethering head aligns in opposition opposing
surfaces of said bone contacting member and said tethering head,
and connection of said bone connecting member to the vertebra
places the contacting surfaces in compression.
8. The member of claim 1, wherein said tethering head has an outer
periphery and the passageway is a groove extending around the
periphery of said tethering head, the groove being adapted and
configured to contain the flexible connector.
9. The member of claim 8, wherein the flexible connector has a
diameter, and the width of the groove is greater than the diameter,
and the depth of the groove is greater than the diameter.
10. The member of claim 8, wherein said tethering head includes a
pair of separated grooves each extending around the periphery of
said tethering head, each groove being adapted and configured to
contain the flexible connector.
11. The member of claim 10, wherein said shaft has an axis, and
each groove is substantially perpendicular to the axis.
12. The member of claim 10, wherein each groove is substantially
parallel to the other groove.
13. A member for tethered connection to a bone, comprising: a bone
connecting member adapted and configured for connection with a
bone; a tethering head separate from said bone connecting member,
said tethering head having a top surface and including a passageway
on the top surface, the passageway being adapted and configured to
accept therein a flexible tether, each said passageway having an
entrance and an exit, the passageway being accessible from the top
of said tethering head; and a cover adapted and configured to cover
the top surface and the passageway
14. The member of claim 13, wherein said cover and said bone
connecting member are integral.
15. The member of claim 13, wherein said bone connecting member
includes a threaded shaft and said tethering head includes an
aperture extending from the top surface of said tethering head
through the bone contacting surface, the aperture being sized to
accept therethrough the shaft.
16. The member of claim 13, wherein said bone connecting member
includes an anchoring head and said tethering head includes a
contacting surface, and connection of said bone connecting member
to the vertebra places the anchoring head in compression against
the contacting surface.
17. The member of claim 13, wherein said tethering head includes a
bone contacting surface, the bone contacting surface being in
contact with the vertebra when said bone connecting member is
connected to a vertebra.
18. The member of claim 13, wherein the entrance and exit are
located proximate to each other such that the flexible tether loops
from the entrance to the exit around a portion of said tethering
head.
19. The member of claim 13, wherein the exit and entrance define a
post therebetween, said post includes smoothly contouring surface
adapted and configured to permit sliding movement of a tether
wrapped around the post without abrasively damaging the tether.
20. The member of claim 13, wherein said passageway is a first
passageway, and which further includes a second passageway on the
top surface, the second passageway being adapted and configured to
accept therein a flexible tether.
21. The member of claim 20, wherein the first and second
passageways are located on opposite sides of said tethering
head.
22. The member of claim 21, wherein each of the first and second
passageways are open to the top surface of said tethering head.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a division of U.S. patent application
Ser. No. 16/361,967, filed Mar. 22, 2019, which claims the benefit
of priority to U.S. Provisional Patent Application No. 62/646,600,
filed Mar. 22, 2018, which are both incorporated herein by
reference.
FIELD OF THE INVENTION
[0002] Various embodiments of the present invention pertain to
apparatus and methods for securing two objects by a flexible
connection, and in other embodiments the interconnection of two
vertebrae or other bones with a flexible connection, such as a
tether or sutures.
BACKGROUND OF THE INVENTION
[0003] Vertebral body tethering (VBT) remains a procedure in the
experimental phase. The behavior of long bone physes are well known
and the effects of guided growth fairly predictable. This is not
the case with the spine. Each vertebra has 2 end plates, acting as
growth plates. How they respond to guided growth is not yet
predictable. Previous work by Betz with the Nitinol staple and
other authors shed some light on the topic. However, questions such
as amount of tension, segmental differences in tension (and
alteration over time under load) and the long term effects on the
discs remain unanswered.
SUMMARY OF THE INVENTION
[0004] One aspect of the present invention pertains to a member for
connection to a vertebra. Some embodiments include a head. Other
embodiments include means for connecting the head to a vertebra.
Still further embodiments include means for coupling
[0005] the head to a flexible material. Examples of flexible
materials include suture and tethers fabricated from organic
materials, and metallic wires. In some embodiments, the flexible
material provides a non-rigid connection between two different
members, with the flexible material capable of sustaining tension
between the members, but substantially not capable of sustaining
compression between the members. Tethers of any cross-sectional
shape are contemplated, including substantially circular cross
sections, elongate cross sections, square cross sections, and flat
cross sections.
[0006] One aspect of the present invention pertains to a member for
connection to a vertebra. Some embodiments include a head. Other
embodiments include means for connecting the head to a vertebra and
means for coupling the head to a flexible material, wherein the
connecting means and the head are separate devices.
[0007] Another aspect of the present invention pertains to a member
for tethered connection to a bone. Some embodiments include a bone
connecting member adapted and configured for connection with a
vertebra. Some embodiments include a tethering head coupled to the
bone connecting member, the tethering head including a passageway
being adapted and configured to accept therein a flexible tether,
the tethering head including an opening providing access to said
passageway, and a separate member adapted and configured to close
the opening.
[0008] Yet another aspect of the present invention pertains to a
member for tethered connection to a bone, including a bone
connecting member and a tethering head non-integral with the bone
connecting member, the tethering head including a passageway being
adapted and configured to accept therein a flexible tether. The
tethering head may include a bone contacting surface, wherein
connection of the bone connecting member to a vertebra places the
bone contacting surface in contact with the vertebra.
[0009] Still another aspect of the present invention pertains to a
member for tethered connection to a bone including a bone
connecting member and a tethering head separable from the bone
connecting member, the head including a passageway adapted and
configured to accept therein a flexible tether, the passageway
being accessible from the top of the tethering head. Some
embodiments include a separate cover adapted and configured to
cover the passageway.
[0010] Another aspect of the present invention pertains to a member
for tethered connection to a bone, some embodiments including a
bone connecting member. Other embodiments include a head including
first and second passageways extending across the head; each
passageway being adapted and configured to accept therein a
corresponding first or second tether, the head including a smoothly
contoured convex lower surface that partially separates the first
passageway from the second passageway.
[0011] Yet another aspect of the present invention pertains to a
member for tethered connection to a bone, some embodiments
including a head attached to the bone connecting member, the head
including first and second spaced apart securement posts each
adapted and configured for connection to a loop of a flexible
tether. In some embodiments each post includes a groove sized to
accept therein a tether loop.
[0012] Still another aspect of the present invention pertains to a
member for tethered connection to a bone including a bone
connecting member and a head attached to the bone connecting
member, the head including first and second peripheral grooves each
adapted and configured for connection to one or more loops of
flexible tether.
[0013] Another aspect of the present invention pertains to a method
for tethering of vertebrae. Some embodiments include attaching a
first tethering head to a first vertebra, attaching a second
tethering head to the first vertebra spaced apart from the first
tethering head, and attaching a third tethering head to a second
vertebra. Other embodiments of the present invention include
attaching one end of a first flexible tether to the first tethering
head and attaching one end of a second flexible tether to the
second tethering head. Still other embodiments pertain to
connecting the first vertebra to the second vertebra by looping the
other end of the first flexible tether with the third tethering
head.
[0014] Yet another aspect of the present invention pertains to a
method for tethering of vertebrae. Some embodiments include
attaching a first tethering head to a first vertebra and attaching
a second tethering head to a second vertebra. Other embodiments
include attaching a flexible tether to the first tethering head,
and extending the tether from the first tethering head to the
second tethering head and passing the extension of the looped
tether though an aperture in the second tethering head.
[0015] It will be appreciated that the various apparatus and
methods described in this summary section, as well as elsewhere in
this application, can be expressed as a large number of different
combinations and subcombinations. All such useful, novel, and
inventive combinations and subcombinations are contemplated herein,
it being recognized that the explicit expression of each of these
combinations is unnecessary.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Some of the figures shown herein may include dimensions.
Further, some of the figures shown herein may have been created
from scaled drawings or from photographs that are scalable. It is
understood that such dimensions, or the relative scaling within a
figure, are by way of example, and not to be construed as
limiting.
[0017] FIG. 1 is a CAD surface representation of a vertebral
tethering member according to one embodiment of the present
invention.
[0018] FIG. 2 is a CAD surface representation of a vertebral
tethering member according to yet another embodiment of the present
invention.
[0019] FIG. 3 is a CAD surface representation of a vertebral
tethering member according to yet another embodiment of the present
invention.
[0020] FIG. 4 is a side elevational view of the apparatus of FIG.
1.
[0021] FIG. 5 is a cross sectional representation of the apparatus
of FIG. 1 as taken along line 5-5 of FIG. 1.
[0022] FIG. 6 is a cross sectional representation of the apparatus
of FIG. 1 as taken along line 6-6 of FIG. 4.
[0023] FIG. 7 is a cross sectional, perspective, and enlarged
representation of a portion of the apparatus of FIG. 6.
[0024] FIG. 8 is a bottom plan view of the apparatus of FIG. 1,
looking from the shank toward the head.
[0025] FIG. 9 is a top plan view of the apparatus of FIG. 1,
looking from the head toward the shank.
[0026] FIG. 10 is a cross sectional view of the apparatus of FIG. 1
as taken along line 10-10 of FIG. 1.
[0027] FIG. 11 is a side elevational view of the apparatus of FIG.
2.
[0028] FIG. 12 is a cross sectional representation of the apparatus
of FIG. 2 as taken along line 12-12 of FIG. 2.
[0029] FIG. 13 is a cross sectional representation of the apparatus
of FIG. 1 as taken along line 13-13 of FIG. 11.
[0030] FIG. 14 is a cross sectional, perspective, and enlarged
representation of a portion of the apparatus of FIG. 13.
[0031] FIG. 15 is an end plan view of the apparatus of FIG. 2,
looking from the shank toward the head.
[0032] FIG. 16 is a top plan view of the apparatus of FIG. 2,
looking from the head toward the shank.
[0033] FIG. 17 is a cross sectional view of the apparatus of FIG. 2
as taken along line 17-17 of FIG. 2.
[0034] FIG. 18 is an enlarged perspective view of a portion of the
apparatus of FIG. 2.
[0035] FIG. 19 is a cross sectional representation of the apparatus
of FIG. 3 as taken along line 19-19.
[0036] FIG. 20 is a perspective view of a portion of the apparatus
of FIG. 19.
[0037] FIG. 21 is a top plan view of the apparatus of FIG. 3 of the
head looking toward the shaft.
[0038] FIG. 22 is a bottom plan view of the apparatus of FIG. 3 of
the shaft looking toward the head.
[0039] FIG. 23 is a CAD surface representation of a vertebral
tethering member according to yet another embodiment of the present
invention.
[0040] FIG. 24 is a cross sectional view of the apparatus of FIG.
23 as taken along line 24-24 of FIG. 23.
[0041] FIG. 25 is a perspective, enlarged view of a portion of the
apparatus of FIG. 24.
[0042] FIG. 26 is a top plan view of the apparatus of FIG. 23 from
the head looking toward the shaft.
[0043] FIG. 27 is a bottom plan view of the apparatus of FIG. 23
from the shaft looking toward the head.
[0044] FIG. 28 is a perspective CAD surface representation of a
vertebral tethering member according to yet another embodiment of
the present invention.
[0045] FIG. 29 is a side elevational view of the apparatus of FIG.
28.
[0046] FIG. 30 is an end elevational view of the apparatus of FIG.
28.
[0047] FIG. 31 is a top plan view of the apparatus of FIG. 28.
[0048] FIG. 32 is a side elevational view of a vertebral tethering
member according to yet another embodiment of the present
invention.
[0049] FIG. 33 is a side elevational view of a vertebral tethering
member according to yet another embodiment of the present
invention.
[0050] FIG. 34 is a side elevational view of a vertebral tethering
member according to yet another embodiment of the present
invention.
[0051] FIG. 35 is a schematic representation of an arrangement of
vertebral tethering members and sutures according to another
embodiment of the present invention.
[0052] FIG. 36A is a schematic representation of an arrangement of
vertebral tethering members and sutures according to another
embodiment of the present invention.
[0053] FIG. 36B shows a portion of tether having 2 free ends.
[0054] FIG. 36C shows the tether of FIG. 36B with the free ends
spliced together to form an endless loop.
[0055] FIG. 36D shows the loop of FIG. 36C attached to a pair of
tethering anchors.
[0056] FIG. 36E shows the portion of tether of FIG. 36B with one of
the free ends spliced to an intermediate portion of the tether in a
way that creates an adjustable loop, in which the size of the loop
can be changed by pulling on the remaining free end.
[0057] FIG. 36F shows the loop of FIG. 36E coupled to a pair of
tethering anchors spaced apart by a first distance.
[0058] FIG. 36G shows the assembly of FIG. 36F after the free end
has been pulled so as to create sufficient tension in the tether
and draw the 2 anchors together and spaced apart by a second
distance that is less than the distance shown in FIG. 36F.
[0059] FIG. 37 is a schematic representation of an arrangement of
vertebral tethering members and sutures according to another
embodiment of the present invention.
[0060] FIG. 38 is a schematic representation of an arrangement of
vertebral tethering members and sutures according to another
embodiment of the present invention.
[0061] FIG. 39 is a schematic representation of an arrangement of
vertebral tethering members and sutures according to another
embodiment of the present invention.
[0062] FIG. 40 is a side, top perspective CAD surface
representation of a vertebral tethering member according to yet
another embodiment of the present invention, shown exploded.
[0063] FIG. 41 shows an assembled view of the apparatus of FIG. 40,
shown assembled.
[0064] FIG. 42 is a frontal view of the apparatus of FIG. 40.
[0065] FIG. 43 is a cross sectional representation of the apparatus
of FIG. 42, with the cross section taken in the plane of the
figure.
[0066] FIG. 44 is a cross sectional representation of the apparatus
of FIG. 42, with the cross section taken in the plane perpendicular
of the figure.
[0067] FIG. 45 is a bottom plan view of the apparatus of FIG.
40.
[0068] FIG. 46 is a top plan view of the apparatus of FIG. 40.
[0069] FIG. 47 is a side, top perspective CAD surface
representation of a vertebral tethering member according to yet
another embodiment of the present invention, shown assembled.
[0070] FIG. 48 shows an assembled view of the apparatus of FIG. 40,
shown exploded.
[0071] FIG. 49 is a bottom plan view of the apparatus of FIG.
47.
[0072] FIG. 50 is a top plan view of the apparatus of FIG. 47.
[0073] FIG. 51 is a side elevational view of the apparatus of FIG.
47.
[0074] FIG. 52 is a frontal view of the apparatus of FIG. 47.
[0075] FIG. 53 is a cross sectional view of the apparatus of FIG.
52, with a cross section parallel to the plane of the figure.
[0076] FIG. 54 is a cross sectional view of the apparatus of FIG.
51, with a cross section parallel to the plane of the figure.
[0077] FIG. 55 is a cross sectional representation of the apparatus
as shown in FIG. 53, expect modified to include a central
cannula.
[0078] FIG. 56 is a side, top perspective CAD surface
representation of a vertebral tethering member according to yet
another embodiment of the present invention, shown assembled.
[0079] FIG. 57 shows an assembled view of the apparatus of FIG. 40,
shown exploded.
[0080] FIG. 58 is a top plan view of the apparatus of FIG. 56.
[0081] FIG. 59 is a bottom plan view of the apparatus of FIG.
56.
[0082] FIG. 60 is a cross sectional view of a side elevational
representation of the apparatus of FIG. 56, with the cross section
taken through the centerline.
[0083] FIG. 61 shows a modification of the apparatus of FIG. 60 to
include a central cannula.
[0084] FIG. 62 is a side, top perspective CAD surface
representation of a vertebral tethering member according to yet
another embodiment of the present invention, shown assembled.
[0085] FIG. 63 shows an assembled view of the apparatus of FIG. 40,
shown exploded.
[0086] FIG. 64 is a photographic representation of the apparatus of
FIG. 62 shown with a portion of tether, hitched to the tethering
head.
[0087] FIG. 65 is a cross sectional representation of the apparatus
of FIG. 66, with the cross section taken in a plane through the
centerline and parallel to the plane of FIG. 66.
[0088] FIG. 66 is a side elevational view of the apparatus of FIG.
62.
[0089] FIG. 67 is a bottom plan view of the apparatus of FIG.
66.
[0090] FIG. 68 is a top plan view of the apparatus of FIG. 66.
[0091] FIG. 69 is a top plan view of a portion of the apparatus
shown in FIG. 63.
[0092] FIG. 70 is a side elevational cross sectional view of the
apparatus of FIG. 66, with a cross section taken through the
centerline and perpendicular to the viewing plane.
[0093] FIG. 71 is a cross sectional representation of an apparatus
similar to that shown in FIG. 70, except having a central
cannula.
ELEMENT NUMBERING
[0094] The following is a list of element numbers and at least one
noun used to describe that element. It is understood that none of
the embodiments disclosed herein are limited to these nouns, and
these element numbers can further include other words that would be
understood by a person of ordinary skill reading and reviewing this
disclosure in its entirety.
TABLE-US-00001 20 spine 22 vertebrae 24 suture or tether loop 25
rod 26 suture approach direction a guiding b hitching c looping 30
vertebral tethering member a guiding b hitching c looping 32 rod
coupling member 34 suture or rod capturing member a connection
feature; threads 40 means for connecting head to vertebra 42 neck
44 anchor a shaft b tip c threads d central axis e cannula 46
plates a through holes; fastener holes b bone contacting surface c
upper surface 47 anchoring head a driving feature b compression
surface c undersurface 50 tethering head a guiding head b hitching
head c looping head 52 planform shape; oblong; circular a maximum
width b central width c driving feature d smooth outer surface e
underside; bone contacting surface f top surface g plane of
symmetry h plane of symmetry i compression surface j bone interface
projections k larger diameter cylindrical aperture; well; head
receiving and locating surface l smaller diameter cylindrical
aperture m head o.d. clearance cylindrical surface 54 passageways a
entrance b exit c width, entrance to exit d inner wall e first
passageway f second passageway h top wall i bottom wall j ears 56
floor a convex feature b V-shape c included angle d ridge 57 suture
capturing member 60 looping head 64 peripheral groove a top b
bottom c width d depth 70 hitching head 73 slot or opening a width
74 securement post a maximum width b radiused edges c overhang d
minimum cross sectional area e angular extent f first g second h
post angle, tether approach
DETAILED DESCRIPTION OF ONE OR MORE EMBODIMENTS
[0095] For the purposes of promoting an understanding of the
principles of the invention, reference will now be made to the
embodiments illustrated in the drawings and specific language will
be used to describe the same. It will nevertheless be understood
that no limitation of the scope of the invention is thereby
intended, such alterations and further modifications in the
illustrated device, and such further applications of the principles
of the invention as illustrated therein being contemplated as would
normally occur to one skilled in the art to which the invention
relates. At least one embodiment of the present invention will be
described and shown, and this application may show and/or describe
other embodiments of the present invention, and further permits the
reasonable and logical inference of still other embodiments as
would be understood by persons of ordinary skill in the art.
[0096] It is understood that any reference to "the invention" is a
reference to an embodiment of a family of inventions, with no
single embodiment including an apparatus, process, or composition
that should be included in all embodiments, unless otherwise
stated. Further, although there may be discussion with regards to
"advantages" provided by some embodiments of the present invention,
it is understood that yet other embodiments may not include those
same advantages, or may include yet different advantages. Any
advantages described herein are not to be construed as limiting to
any of the claims. The usage of words indicating preference, such
as "preferably," refers to features and aspects that are present in
at least one embodiment, but which are optional for some
embodiments, it therefore being understood that use of the word
"preferably" implies the term "optional."
[0097] The use of an N-series prefix for an element number
(NXX.XX)refers to an element that is the same as the non-prefixed
element (XX.XX), except as shown and described. As an example, an
element 130 would be the same as element 30, except for those
different features of element 130 shown and described. Further,
common elements and common features of related elements may be
drawn in the same manner in different figures, and/or use the same
symbology in different figures. As such, it is not necessary, as
one example, to describe features of 154 and 54 that are the same,
since these common features are apparent to a person of ordinary
skill in the related field of technology. Further, it is understood
that some features may be backward compatible, such that a feature
of a later discussed embodiment (NXX.XX) may include features
compatible with other various embodiments that were discussed
earlier (MXX.XX) as would be understood by those of ordinary skill
in the art. This description convention also applies to the use of
prime ('), double prime (''), and triple prime (''') suffixed
element numbers. Therefore, it is not necessary to describe the
features of 20.1, 20.1', 20.1'', and 20.1''' that are the same,
since these common features are apparent to persons of ordinary
skill in the related field of technology.
[0098] This document may use different words to describe the same
element number, or to refer to an element number in a specific
family of features (NXX.XX). It is understood that such multiple,
different words are not intended to provide a redefinition of any
language herein. It is understood that such words demonstrate that
the particular feature can be considered in various linguistical
ways, such ways not necessarily being additive or exclusive.
[0099] Although various specific quantities (spatial dimensions,
temperatures, pressures, times, force, resistance, current,
voltage, concentrations, wavelengths, frequencies, heat transfer
coefficients, dimensionless parameters, etc.) may be stated herein,
such specific quantities are presented as examples only, and
further, unless otherwise explicitly noted, are approximate values,
and should be considered as if the word "about" prefaced each
quantity. Further, with discussion pertaining to a specific
composition of matter, that description is by example only, and
does not limit the applicability of other species of that
composition, nor does it limit the applicability of other
compositions unrelated to the cited composition.
[0100] Various embodiments of the present invention pertain to
different methods and apparatus for providing a flexible connection
among the vertebra of a spine, and also different methods for
providing a connection between a vertebra and a rod. Various
tethering heads are shown which provide one or more of a looping
attachment of one or more suturing loops, guidance of the suture
loop over several vertebrae, or the hitching attachment of multiple
suturing loops. Each of the tethering heads can include any
acceptable means for attachment to a vertebrae. Examples shown
herein include screw-type bone anchors and fastener-coupled bone
plates. However, the tethering heads and tethering methods
discussed herein can be attached by any method.
[0101] Further shown herein are various methods for using one or
more of the tethering heads in combination on a particular patient.
As examples, looping-type or hitching-type tethering heads can be
utilized for attachment of the loop itself to the tethering head.
Various methods contemplate multiple tethering heads being attached
to one vertebrae, and connected or guided with a single tethering
head on an adjacent vertebrae. As will be shown, the tethering
heads discussed herein permit the simultaneous use of one or more
suturing loops across one or more vertebrae. In some of the present
invention include tethering members that include one piece, unitary
devices incorporating both a tethering head and an anchoring means.
However, yet other embodiments contemplate separation of the two
functions, such that the tethering head is attached to a vertebra
by a separate anchoring means, such as a screw, pin, plate, or
other device disclosed herein.
[0102] FIGS. 1, 2, and 3 show side elevational views of vertebral
tethering members 30, 130, and 230, respectively, each having
tethering heads X50 according to various embodiments of the present
invention. FIG. 1 shows a tethering head 50a that is adapted and
configured to guide within the head the strands of a loop of
tethering or suturing material. FIG. 2 presents a side elevational
view of a tethering head 150c adapted and configured to provide one
or more "hitching" posts that are adapted and configured to receive
around each of them a loop of tethering or suturing material. FIG.
3 shows a tethering head 250b adapted and configured to receive in
a groove around its periphery a loop of tethering or suturing
material. Unless otherwise stated, the various tethering heads X50
disclosed herein provide securement of the flexible tether to the
head, but preferably without compressing, abrading, or restricting
the movement of the flexible tether within the various passageways
X54.
[0103] FIGS. 1 and 4-10 show various views of a vertebral tethering
member 30 according to one embodiment of the present invention.
Tethering member 30 includes a tethering head 50a and means 40 for
connecting the head to a vertebrae. Tethering head 50a includes
within it an upside down, enclosed V-shaped passageway 54. In the
embodiment shown, connecting means 40 is an anchoring screw 44 that
includes a plurality of threads 44c on a shaft 44a. Connecting
means 40 extends from a neck 42 that attaches to the underside of
head 50a to a tip 44b that is adapted and configured to be inserted
into a hole in the vertebrae. The necks X42 shown herein preferably
include increased cross sectional areas proximate to this
attachment, so as to manage the distribution of stresses and forces
transitioning between the head and the connection means.
[0104] As shown and described herein, means X40 for connecting a
head X50 to a vertebrae can be any type of device or method that
securely affixes the head X50 to the vertebrae. Examples include
the anchoring screws shown in several embodiments herein, as well
as a plate, post, hook, clip, or strap, as examples. In the
embodiments shown, the connection means 40 includes a neck X42 that
provides attachment to the underside 52e of the head 50.
[0105] Tethering head 50a includes within it a passageway 54, as
best seen in FIGS. 5, 6, and 7. In some embodiments, this larger
passageway 54 includes separated first and second passageways 54e
and f, preferably arranged in a V-shape. Although as shown in FIGS.
6 and 7, the V-shape is "upside down" (with the vertex of the V
being proximate to the top surface 52f of the head), yet other
embodiments include passageways separated in yet other
configurations, including V-shapes with the vertex pointed
downward, FIG. 8 shapes, barbell shapes, and the like. Still
further, yet other embodiments include single passageways of
rounded, smooth cross sectional shapes, including circular and
elliptical cross sectional shapes, including shapes that are not
separated into multiple passageways. Still further, although what
has been shown and described includes tethering heads having two
passageways, it is further contemplated in yet other embodiments
that the tethering heads can include three or more smoothly
separated passageways, including separation features having cross
sectional shapes resembling a smooth, rounded upside down W-shape.
Passageways 54e and 54f are adapted and configured to permit the
passage therethrough of the 2 strands of a single continuous (or
endless) loop of tethering material. The end of the loop and the
strands of the loop are provided to the entrance 54a of the
passageways, and leave the passageway through exit 54b (referring
to FIG. 9). It is understood that the terms entrance and exit are
used for convenience, and that the loop and strands can be entered
or exited through either side. Referring to FIG. 9, it can be seen
that the shape 52 of head 50 is symmetric about the two planes 52g
and 52h as shown. However, other embodiments of the present
invention contemplate shapes of tethering heads that have only a
single plane of symmetry, or no symmetry at all. In such
embodiments, one of the entrance and exit may have one or more
distinctly different features than the other of the entrance or
exit.
[0106] Referring to FIG. 7, in some embodiments the passageways 54f
and 54e are separated by a convex feature 56a located on the floor
56 of the passageway. In the embodiment shown, the convex feature
56a is a ridge 56d that extends generally across the width 52b of
the head 50a. Referring to FIGS. 6 and 7, this central ridge can be
seen to generally follow the upside down V-shape 56b, except with
substantially smooth, rounded contours. These smooth and rounded
contours of the floor (as well as elsewhere in the various
passageways and shapes of the heads X50 shown herein) are useful in
minimizing stress concentrations that would otherwise arise in the
tethering material, and which could otherwise result in abrasion
and potential failure of the tethering material. Although the
convex feature 56a of floor 56 is shown as a ridge 56d (in FIG. 7),
it is also understood that the convex floor need not extend across
the entire width of the passageway, and as another example could be
one or more bumps in the floor. It is also understood that other
features (such as a convex ceiling of the passageway) could also
provide separation of the laterally opposed passageways 54e and
54f.
[0107] Referring to FIG. 9, it can be seen that in some embodiments
the tethering head 50a has a smooth outer peripheral surface 52d
and top surface 52f. In the embodiments shown, the head 52 has an
oblong shape, with a maximum width 52a and a central width 52b. As
shown in FIG. 9, in some embodiments all peripheral sides of the
planform of the head are rounded and smooth so as to minimize
abrasion of the tethering loops.
[0108] Comparing FIGS. 9 and 10, it can be seen that the opposing
inner walls 54d of the passageway have a width 54c from entrance to
exit that is less than the central width 52b of the head shape 52,
a result at least in part of the oblong planform shape 52 of the
head. In addition, referring to FIG. 9, it can be seen that the top
52f of the head proximate to central plane 52h is slightly relieved
inwardly relative to the bottom surface 54i. This slight pullback
of the passageway entrance and exit from the edges of the head,
combined with the use of an oblong shape in which the passageway
cuts through the smaller width of the oblong shape, allows for a
wider variation in the approach and departure directions of the
loop relative to the passageways.
[0109] FIGS. 5, 9 and 10 provide examples of the approach and
departure directions of the suture loop relative to head 50a.
Preferably, the suture direction 26a is generally through
passageway 54, and across the central width 52b. The approach
direction 26a shown in FIG. 5 schematically represents this
direction, yet the head 50a is adapted and configured such that the
approach need not be orthogonal to any particular feature,
centerline or symmetry plane of the head. FIG. 9 and FIG. 10
illustrate various approach and departure directions that are
acceptable by considering the many smooth, contoured features of
the overall head shape, as well as the features previously
discussed relative to the entrance and exit of the passageway.
[0110] FIGS. 2 and 11-18 show various views of a vertebral
tethering member 130 according to another embodiment of the present
invention. Tethering member 130 includes a tethering head X50b and
means 40 for connecting the head to a vertebrae. Tethering head
150b includes within it an upside down, enclosed V-shaped
passageway 154. In the embodiment shown, connecting means 140 is an
anchoring screw 44 that includes a plurality of threads 44c on a
shaft 44a. Connecting means 40 extends from a neck 42 that attaches
to the underside of head 50b to a tip 44b that is adapted and
configured to be inserted into a hole in the vertebrae. The necks
X42 shown herein preferably include increased cross sectional areas
proximate to this attachment, so as to manage the distribution of
stresses and forces transitioning between the head and the
connection means.
[0111] As shown and described herein, means X40 for connecting a
head X50 to a vertebrae can be any type of device or method that
securely affixes the head X50 to the vertebrae. Examples include
the anchoring screws shown in several embodiments herein, as well
as a plate, post, hook, clip, or strap, as examples. In the
embodiments shown, the connection means 40 includes a neck X42 that
provides attachment to the underside 52e of the head 50.
[0112] Tethering head 150b includes within it a passageway 154, as
best seen in FIGS. 5, 6, and 7. In some embodiments, this larger
passageway 154 includes separated first and second passageways 154e
and f, preferably arranged in a V-shape. Although as shown in FIGS.
6 and 7, the V-shape is "upside down" (with the vertex of the V
being proximate to the top surface 152f of the head), yet other
embodiments include passageways separated in yet other
configurations, including V-shapes with the vertex pointed
downward, FIG. 8 shapes, barbell shapes, and the like. Still
further, yet other embodiments include single passageways of
rounded, smooth cross sectional shapes, including circular and
elliptical cross sectional shapes, including shapes that are not
separated into multiple passageways. Still further, although what
has been shown and described includes tethering heads having two
passageways, it is further contemplated in yet other embodiments
that the tethering heads can include three or more smoothly
separated passageways, including separation features having cross
sectional shapes resembling a smooth, rounded upside down W-shape.
Vertebral tethering member 130 includes a "hitching" or
looping-connection head 150b. Comparing FIGS. 13 and 6, it can be
seen that the head 150b includes a passageway 154 that looks
similar to the passageway 54, except that a slot or opening 73
extends across the top surface 152f. Other similarities between
member 130 and member 30 can be seen, such as the passageways 154e
and 154f on opposite sides of head 150b, with the passageways being
angled in an approximate V-shape 156b, with the included angle 156c
of the V-shape being preferably greater than about ninety degrees.
Further in comparison of FIGS. 13 and 6, it can be seen that the
floor 156 includes a convex feature 156a that roughly parallels the
V-shape with a smooth ridge 156d.
[0113] One difference between a tethering head X50a and a tethering
head X50b is the manner in which the head interfaces with the
suture loop. As previously discussed, a tethering head X50a is
adapted and configured to guide within it the strands of a tether
loop. The tether has an approach direction 26a that in some
embodiments has the loop passing through a pair of exits (on
lateral sides of the passageway) and a pair of exits (also on
corresponding lateral sides of the passageway).
[0114] In comparison, a tethering head X50b in some embodiments
contemplates a suture loop approaching direction 26b (referring
briefly to FIGS. 15 and 17) that is generally orthogonal to the
approach direction 26a. As best seen in comparing FIGS. 14 and 16
to FIGS. 7 and 9, respectively, is that a tethering head X50b is
adapted and configured to be loopingly connected (or hitched) to a
post X74 of the head X50b. Referring briefly to FIGS. 13 and 17, it
can be seen that the suture approach direction 26b is in a
direction generally orthogonal to the approach direction 26a for a
head 50a, as seen in FIGS. 5 and 10.
[0115] Yet another difference between a tethering head X50a and a
tethering head X50b is the placement of a slot 173 that extends
through the top surface 152f of a head X50b. This slot 173
preferably has a width 173a and also smoothing and contouring
features that adapt it and configure it to permit downward passage
of a loop of suture. Referring to FIG. 14 and FIG. 18, it can be
seen that the slot, combined with preferably significantly radiused
edges 174b proximate to a minimum cross sectional area 174d, in
combination with passageways 154e and 154f, create first and second
suture loop hitching posts 174f and 174g.
[0116] A tethering head X50b according to various embodiments of
the invention is attached to an undercut location along either of
two laterally facing posts 174f or 174g. Comparing FIGS. 13 and 17,
it can be seen that the suture loop approach direction 26b does not
have to be at a right angle (as suggested by FIG. 13) but can be at
any angle (as shown in FIG. 17) that still permits the loop to be
protectively retained under the overhang 174c of the attachment
post 174.
[0117] FIG. 17 shows additional features that permit a variety of
approach directions toward the hitching post 174. As one example,
it can be seen that the width of the passageway 154c is shorter
than the maximum width 174a of the post (as shown toward the bottom
of FIG. 17). A radiused edge 174b transitions from width 154c of
the inner wall 154d to the maximum width 174d. This radius 174b is
adapted and configured to eliminate or minimize any stress
concentration in the suture loop as it wraps around the corner
174b. FIG. 17 also shows that the angular extent 174e defined
between the tangent lines 174h is in excess of ninety degrees.
Comparing FIGS. 15 and 17, it can be seen that the radiused corners
174b and angular extent 174e of the entrance or exit permits a
variety of suture approach directions that can differ significantly
from the plane 152g that includes the major axis of the oblong
head.
[0118] These various contouring features described above, along
with the slot 173 and V-shape 156b, also combine to create an
overhanging portion 174c for each post. This overhanging portion
174c (best seen in FIGS. 13 and 18) extends from the respective
post in a direction generally opposite to the direction of tension
that would be applied to the suture loop. Because of this overhang,
any attempt at vertical movement of the suture loop is discouraged,
since any movement of the suture loop away from the minimal cross
sectional area 174d and toward the overhand 174c would require
increased tension in the loop, and thus resist the attempted
vertical movement. Therefore, the placement of the minimum cross
sectional area between the overhand 174c and the floor convex
feature 158 discourages top to bottom movement of the loop, and
encourages placement of the loop around the minimum cross sectional
area.
[0119] FIGS. 3 and 19-22 show various views of a vertebral
tethering member 230 according to another embodiment of the present
invention. Tethering head 250c includes around it one or more
peripheral grooves 264 that are adapted and configured to receive
within them a tether that is looped around the periphery. In the
embodiment shown, connecting means 240 is an anchoring screw 44
that includes a plurality of threads 44c on a shaft 44a. Connecting
means 40 extends from a neck 42 that attaches to the underside of
head 50a to a tip 44b that is adapted and configured to be inserted
into a hole in the vertebrae. The necks X42 shown herein preferably
include increased cross sectional areas proximate to this
attachment, so as to manage the distribution of stresses and forces
transitioning between the head and the connection means. As shown
and described herein, means X40 for connecting a head X50 to a
vertebrae can be any type of device or method that securely affixes
the head X50 to the vertebrae. Examples include the anchoring
screws shown in several embodiments herein, as well as a plate,
post, hook, clip, or strap, as examples. In the embodiments shown,
the connection means 40 includes a neck X42 that provides
attachment to the underside 52e of the head 50.
[0120] Vertebral tethering member 230 includes a tethering head
250c adapted and configured for looping connection to a flexible
tether or suture. Referring to FIG. 19, it can be seen that a
tethering head X50c preferably includes a peripheral groove 264
that extends around the smooth outer surface 252d of head 250c. In
one embodiment, this groove is recessed into the periphery, with
the inner wall 254d of the groove being smoothly contoured and
rounded for minimal abrasion with a suture loop placed within the
groove. In one embodiment, as shown in FIG. 19, the inner wall 254d
has a semi-circular shape, although other embodiments of the
present invention contemplate smoothly contoured and rounded walls
of any shape, including walls having elliptical cross sections and
parabolic cross sections as examples.
[0121] Preferably, the groove includes a top and bottom pair of
walls 254h and 254i, respectively that, combined with the innermost
wall 254d, form the suture loop passageway 254. Preferably, this
passageway has a width 264c greater than the unstressed diameter of
the suture material, as well as a depth 264d greater than the
unstressed diameter of the suture material. By having groove
dimensions greater than the unstressed diameter, the physician will
easily wrap the unstressed loop around and into passageway 254, and
preferably without the need to push or force the suture material
into the groove. However, yet other embodiments of the present
invention contemplate a groove 264c in which the unstressed
material fits tightly and securely within the groove.
[0122] In a manner similar to the post overhangs 174c previously
discussed, the top and bottom surfaces 254h and 254i, combined with
the depth 264d of passageway 254, result in the implanted suture
remaining securely within the groove, and not escaping the groove
even if the tension on the suture is slightly relieved. The
overhang of the top and bottom walls 254h and 254i also provide
protection to the suture loop within groove 254 from abrasion from
other nearby features.
[0123] It is noted that the suture placed within groove 264 should
be large enough to fit over the peripheral shape 252 of the head
250c, as best seen in FIG. 21. Comparing head 250c and 150b (shown
in FIG. 16), it can be seen that the loop of suture material for
head X50b should be large enough to fit over the top surface 152f
of a post 174.
[0124] FIGS. 23, 24, and 25 depict various aspects of a vertebral
tethering member 330 similar to the member 230 previously
discussed. Member 330 is similar to member 230, except including a
pair of spaced apart peripheral grooves 364a and 364b. Preferably,
these grooves are spaced apart vertically from the underside, bone
contacting surface 352e. Member 330 permits a single tethering
member to apply tension in two different directions, each direction
being provided by a different suture loop.
[0125] FIGS. 21 and 22 show top and bottom views, respectively, of
tethering member 230. FIGS. 26 and 27 show similar top and bottom
views, respectively, of tethering member 330. Each tethering member
includes a central driving feature 252c for applying torque to the
tethering member. Further, both tethering members permit a variety
of suture approach directions 26c, as shown with FIG. 21. The
strands of the suture can exit radially outwardly in any direction.
Still further, a strand (and not a complete loop) can be wrapped
part way around the groove, and depart (or approach) a head X50c
tangentially to the groove, as expressed by the arrow 26c of FIG.
21 shown at about the three o'clock position. It is understood that
the tethering member 330, as discussed above, is adapted and
configured to provide connection to two different suture loops,
each approaching in two different directions, and in any of the
manners discussed with regard to tether member 230.
[0126] FIGS. 28-30 show various views of a vertebral tethering
member 430 according to one embodiment of the present invention.
Tethering member 430 includes a tethering head 50a and means 40 for
connecting the head to a vertebrae. Tethering head 50a includes
within it two, enclosed, separated passageways 454.
[0127] In the embodiment shown, connecting means 440 is a plate
adapted and configured to be attached by a plurality of vertebral
anchors (not shown) to a vertebrae. Connecting means 440 has a
generally rectangular planform shape and includes a plurality of
through holes 446a adapted and configured for securement of the
plate 446 to the vertebrae by the connecting means. Although what
is shown and described is a rectangular plate having four evenly
spaced holes for fasteners, it is understood that the shape of
plate 446 can be of any type adapted and configured for attachment
to a vertebrae.
[0128] Tethering member 430 includes a guiding head X50a adapted
and configured for providing passage therethrough of a suture loop.
Head 450a includes a pair of spaced apart passageways 454f and 454e
separated completely by a ridge 456d. Referring to FIGS. 28, 30 and
31, it can be seen that the entrance and exit of the passageways
are rounded and smoothly contoured to permit a variety of suture
approach directions 26a, with minimal or no abrasion to the suture
loop.
[0129] In some embodiments, each passageway 454e or 454f can
provide guidance therethrough for both strands of a suture loop. In
yet other embodiments, the individual strands of the suture loop
are separated, with one strand passing through each of the
passageways. In still further embodiments, it is understood that a
single passageway 454e or 454f can be sized and adapted and
configured to permit passage therethrough of multiple loops, single
strands of different loops, or combinations thereof.
[0130] FIGS. 32, 33, and 34 depict yet further embodiments of the
present invention, each including in the example shown a plate X46
for attachment of the tethering head to the vertebrae. FIG. 32 is a
side elevational view of a tethering member 530 which is similar to
tethering head 430 as shown and discussed. However, each of the
passageways 554e and 554f include respective slots 573 that permit
a suture loop to be passed into the corresponding passageway.
[0131] FIG. 33 shows a side elevational view of a vertebral
tethering member 630 according to another embodiment of the present
invention. Tethering member 630 is similar to tethering member 430
previously shown and discussed. However, tethering head 630
includes a convex feature 656a extending generally from a first
surface 646c of plate 646, but not extending completely to the top
wall 654h of head 650a. The cross sectional shape of head 650a as
shown in FIG. 33 is similar in function to the fastener head 50a
previously shown and discussed with regards to tethering member 30.
However, it is appreciated that the cross sectional shape of the
passageways is more of a figure-8 or barbell shape.
[0132] FIG. 34 shows a side elevational view of a tethering member
730 according to another embodiment of the present invention.
Tethering member 730 includes connection means 740 comprising a
plate 746 similar to that shown and discussed with regards to
embodiment 430. However, member 730 includes a hitching-type
tethering head 750b having function similar to that of anchor 130
previously discussed. Head 750b is adapted and configured to
provide a pair of spaced apart posts 774f and 774g having function
similar to the aforementioned hitching post.
[0133] FIGS. 35-39 depict the implantation and usage of the
vertebral tethering members X30 described herein. As will be shown
and discussed, various combinations of different tethering members
X30 can be attached to adjacent vertebrae, or to the same
vertebrae. A plurality of the tethering members X30 can be
interconnected to one or several other tethering members X30.
Further, these tethering interconnections can be accomplished with
one or multiple loops of suturing or tethering material.
[0134] FIG. 35 shows a plurality of looping connection tethering
members 230 and/or 330. In the top portion of FIG. 35, a pair of
tethering members 330 are shown coupled to adjacent vertebrae 22 of
a spine 20. A single suture loop 24-1 is shown interconnecting the
two tethering heads X50c. At the bottom of FIG. 35, a second,
separate tethering loop 24-2 is shown looped around the peripheral
grooves 264 of vertebral tethering members 230, each secured to
different vertebrae.
[0135] FIG. 36A shows a single tethering loop 24-1 extending from a
topmost tethering member 230 to a bottommost tethering member 330.
The single tethering loop passes through three tethering members
30a, each having a tethering head 50a that provides guidance for
the passage therethrough of the single suture loop.
[0136] FIGS. 36B-36G show various depictions of tethered anchors
arranged in discrete segments. These figures, as well as other
figures shown herein, show the tethering together of anchors with a
loop of tethering material. In some embodiments, these loops are
prepared by manipulating a loose, free piece of tether (with 2 free
ends) into a loop. Non-limiting examples of such loops include
loops with no remaining free ends; loops in which both free ends
remain, after splicing; a single loop with 1 fixed free end
extending from the loop; and a single loop in which 1 free end
extends from a joint or splice that permits a pulling on the free
end, with a subsequent change in the dimension of the loop. It will
be understood by those of ordinary skill in the art that the
splicing can be accomplished in any manner, including: splicing;
use of knots; a single attachment crimping each end together;
separate crimped attachments, one for each end, with the crimped
attachments being attached together; mechanical joints; fusing,
such as by heat or ultrasonics; adhesives; or any other manner.
[0137] FIG. 36B shows a portion of tether 24 having 2 free ends 24a
and 24b. FIG. 36C shows tether 24 with the free ends spliced
together to form an endless loop. FIG. 36D shows the loop 24 of
FIG. 36C is attached to a pair of tethering anchors X 30c. In some
embodiments, the loop 24 is spliced in a manner that the loop has a
fixed size. Therefore, if this loop is attached to a pair of
tethering anchors, the loop of tether will be in tension if there
is relative movement of the 2 anchors, such that there is an
attempt for the anchors to spread apart. As shown in FIG. 36D, the
anchors will spread apart commensurate with the fixed geometry of
the loop, placing the loop in tension, and further increasing that
amount of tension if further separation is attempted.
[0138] FIG. 36E shows the portion of tether 24 of FIG. 36B with one
of the free ends spliced to an intermediate portion of the tether
in a way that creates an adjustable loop. The size of the loop in
FIG. 36E can be changed by pulling on the remaining free end. In
some embodiments, this change in length is a one-way change in
length, such that the configuration of the spliced connection
prevents subsequent enlargement of the loop. As examples, the
remaining free end 24a may be pulled through a crimp-type
attachment until the desired tension is achieved, at which point
the crimp is tightened or deformed so as to lock the free end and
lock the configuration of the loop. Still further, one-way
attachments similar to those used in electronics (such as cable
ties or zip ties) can be used, in which the free end is not fixed
to the loop, but after pulling and tensioning of the loop, is
unable to move backwards through the one-way joint. FIG. 36F shows
the loop of FIG. 36E coupled to a pair of tethering anchors spaced
apart by a first distance.
[0139] FIG. 36G shows the assembly of FIG. 36F after the free end
has been pulled so as to create sufficient tension in the tether
and draw the 2 anchors together. The resultant configuration shows
the 2 anchors spaced apart by a second distance that is less than
the distance shown in FIG. 36F. The tension in the loop 24 of FIG.
36G would be proportional to the amount of resistance encountered
in changing the spacing of the 2 anchors from the first, greater
distance to the second, lesser distance. Such changing of the
relative spacing could be a result of movement of the 2 vertebrae
as the patient moves; growth of the patient; or tensioning of the
loop by the surgeon.
[0140] Referring to FIG. 37, a spine 20 has implanted within it a
plurality of tethering members X30, each of which is interconnected
by separate tethers to adjacent tethering members. A first suture
loop 24-1 passes around the peripheral groove 364 of a member 330,
and then to a first post 174f of the member 130 attached to the
adjacent vertebrae. A second suturing loop 24-2 interconnects the
other securement post 174g to a tethering post 174f secured to an
adjacent vertebrae. This pattern continues through several adjacent
vertebrae.
[0141] It is further understood that the present invention also
contemplates combining in one implantation a mixture of looping
members 230 or 330, with both guiding members 30 as well as
hitching members 130. For example, in the implantation
constructions shown in FIG. 34, the central-most hitching member
130x could be replaced with a guiding member 30x, such that the
loop 24-2 extends through the guiding member 130, and is then
linked to a post of the next adjacent hitching member 130. In such
a construction, the vertebrae to which guiding member 30x is
attached would be somewhat freer to establish its own position
between the adjacent vertebrae.
[0142] Referring to FIG. 38, a pair of vertebral tethering members
130-1 and 130-2 have been secured to a single vertebrae. A third
tethering member 130-3 has been secured to an adjacent vertebrae. A
common securement post 174f is connected by two suture loops 24-1
and 24-2 to the suturing post 174g-1 and 174g-2 of corresponding
members 130-1 and 130-2. In this manner, the lateral offset between
members 130-2 and 130-1 can apply a rotational torque of vertebrae
22-1 relative to vertebrae 22-2.
[0143] FIGS. 40-71 pertain to still further embodiments 8XX, 9XX,
10XX, and 11XX. Persons of ordinary skill will understand that
these embodiments can include various of the features previously
shown and described for embodiments XX, 1XX, 2XX, 3XX, 4XX, 5XX,
6XX, and 7XX, without the need to state each and every one of these
many combinations.
[0144] FIGS. 40-46 show various views of a vertebral tethering
member 830 according to another embodiment of the present
invention. Member 830 includes various design aspects found in
either of tethering members 30 or 130 as previously discussed.
Tethering member 830 includes a tethering head X50b and means 40
for connecting the head to a vertebrae. Tethering head 850b
includes within it an upside down, enclosed V-shaped passageway
854. In the embodiment shown, connecting means 840 is an anchoring
screw 844 that includes a plurality of threads 844c on a shaft
844a. Connecting means 840 extends from a neck 842 that attaches to
the underside of head 850b to a tip 44b that is adapted and
configured to be inserted into a hole in the vertebrae. The necks
X42 shown herein preferably include increased cross sectional areas
proximate to this attachment, so as to manage the distribution of
stresses and forces transitioning between the head and the
connection means.
[0145] Tethering head 850b includes within it a passageway 854. In
some embodiments, this passageway 854 includes separated first and
second passageways 854e and f, preferably arranged in a V-shape.
Although as shown in FIGS. 6 and 7, the V-shape is "upside down"
(with the vertex of the V being proximate to the top surface 852f
of the head), yet other embodiments include passageways separated
in yet other configurations, including V-shapes with the vertex
pointed downward, FIG. 8 shapes, barbell shapes, and the like.
Still further, yet other embodiments include single passageways of
rounded, smooth cross sectional shapes, including circular and
elliptical cross sectional shapes, including shapes that are not
separated into multiple passageways. Still further, although what
has been shown and described includes tethering heads having two
passageways, it is further contemplated in yet other embodiments
that the tethering heads can include three or more smoothly
separated passageways, including separation features having cross
sectional shapes resembling a smooth, rounded upside down
W-shape.
[0146] Vertebral tethering member 830 includes a head 850b that can
provide either the "hitching" or looping-connection shown in head
150b as well as the guiding support of head 50a of member 30.
Comparing FIGS. 42 and 2, it can be seen that the head 850b
includes a passageway 854 that looks similar to the passageway 154,
except that tethering member 830 includes a suture capturing member
834 that closes the slot or opening 873.
[0147] Referring to FIG. 43, it can be seen that in one embodiments
the capturing member 834 is a setscrew that includes a plurality of
external threads 834e that are threadably received within the
connection feature 857. Comparing FIGS. 40 and 42, it can be seen
that a loop of tether can be placed within the V-groove 854, so as
to mount one or more suture loops in a hitching manner around a
securement post 874, in a manner as previously described relative
to tethering member 130. Placement of the capturing member 834
within the slot 873 subsequently closes the slot, preventing escape
of any of the loops being hitched to or placed within member 830.
However, the securement of capturing member 834 within slide 873
preferably does not compress the flexible tether, and preferably
further does not contact the flexible tether. Therefore, even with
setscrew 834 firmly coupled to threads 834e, the pathway 854 is
unconstrained, and the flexible tether can move freely within
passageway 854.
[0148] Alternatively, one or more suture paths can be guided within
passageway 854 in a manner as previously described for tethering
member 30. However, because tethering head 850b incorporates an
opening 873 that extends entirely across the top surface 852 and
into passageway 854, the guided sutures can be placed within
passageway 854 from above the head and through slot 873. This is in
contrast to member 30 in which the sutures are preferably guided
through passageway 54 by entering the passageway on one lateral
side of the head and bringing the suture out of the opposite side
of the lateral head.
[0149] By use of a suture capturing member 834 to securely close
slot 873, a tethering member 830 can provide guidance or hitching
of suture material, similar to members 30 and 130, respectively,
described previously. The suture can be a simple pass through, in
which the suture approaches slot 854 in a manner at least somewhat
parallel to the pathway or the slot, or alternatively can approach
the pathway 854 orthogonally for hitching-type securement. It is
also understood that the securement post or head lateral sides 874
can be of the configuration discussed with regards to FIG. 17,
except that the opposing surfaces of the overhangs 874c are
preferably adapted and configured for securement to the capturing
member, such as the threads shown in FIGS. 43 and 44.
[0150] Other similarities between member 830 and members 30 and 130
can be seen, such as the passageways 854e and 854f on opposite
sides of head 850b, with the passageways being angled in an
approximate V-shape 856b, with the included angle 856c of the
V-shape being preferably greater than about ninety degrees. Further
in comparison of FIGS. 13 and 6, it can be seen that the floor 856
includes a convex feature 856a that roughly parallels the V-shape
with a smooth ridge 856d.
[0151] FIGS. 47-55 show various views of a vertebral tethering
member 930 according to one embodiment of the present invention.
Tethering member 930 includes a tethering head 950a and means 40
for connecting the head to a vertebrae. Tethering head 50a includes
within it a pair of separated passageways 954. In the embodiment
shown, connecting means 40 is a separable anchoring screw 44 that
includes a plurality of threads 944c on a shaft 44a. Connecting
means 40 extends from a head 947 to a tip 944b that is adapted and
configured to be inserted into a hole in the vertebrae.
[0152] Vertebral tethering member 930 in some embodiments is an
assembly of a tethering head 950a that is separate from the
anchoring means 940. Referring to FIG. 48, it can be seen that
connecting means 940 includes a head 947 attached to a shaft 944a
that has a plurality of bone-engaging threads 944c. Head 947
preferably incorporates a driving feature 947a that receives a tool
operated by the user, through which a torque can be applied to
connecting means 940.
[0153] Referring to FIGS. 48, 53, and 54, it can be seen that head
950a includes a through aperture that receives therein the head and
shaft of connecting means 940. The through aperture includes a
first, larger cylindrical well 952k that slidably receives the
outer surface of head 947. A second, smaller diameter aperture 952l
that extends the rest of the way through the bottom surface of head
950a. Preferably, either one of these cylindrical surfaces 952k or
952l are close-fitting to the corresponding outer diameter of
anchoring means 940, with the other of cylindrical well 952k or
aperture 952l being a clearance fit.
[0154] Separating the two inner diameters is a compression surface
952i that abuts against a compression surface 947b of head 947.
When torque is applied to connecting means 940, the two compression
surfaces come into contact, and connecting means 940 pulls head
950a into contact with the vertebra.
[0155] With this separation of the anchoring means from the
tethering head, it is possible for the user to provide any angular
orientation to the tethering head, with such angular orientation
being maintained while connecting means 940 is rotated and
tightened. In some embodiments, the frictional interface between
compression surfaces 952i and 947b may be coated to provide
desirable characteristics. As one example, one or more of the
surfaces can be coated with a low friction substance.
[0156] In yet another embodiment shown in FIG. 55, the connecting
means 940 can include a cannula adapted and configured for a
surgical tool such as a guide wire or guide pin. In some
embodiments, the installation of tethering member 930 may be
facilitated by the use of one or more tools to provide accurate
location of member 930. As one example, the surgeon can determine
where best to locate the separate tethering head 950a. Once the
location is established, a tool (not shown) having a cross
sectional shape similar to that of the head and neck of connecting
means 940 can be placed within the well 952k. A small central hole
within the tool then provides guidance for another tool, such as a
drill or a pin, which can be placed through the central hole of the
tool. The surgeon can use this tool to accurately locate the hole,
and then using the same tool, or another different tool, provide
guidance for a drill that creates the hole for coupling to the
threads 944c.
[0157] Referring to FIGS. 47 and 50, it can be seen that head 950a
has a generally cylindrical planform shape 952, with a pair of ears
954j extending from opposite sides. Each of the ears 954j contain
within them the corresponding passageway 954e or 954f, through
which the suture material is passed. As shown in these figures, the
ears 954j are located on opposite sides of the planform shape 952,
and as seen in FIG. 50, the tethering head 958 is symmetrical about
planes 952g and 952h.
[0158] However, the present invention also contemplates those
embodiments in which the outwardly extending ears 954j are not
located on opposite sides, but instead have a relative angular
orientation that is other than 180 degrees of separation. Further,
yet other embodiments contemplate heads 950a that have more than
two outwardly extending ears 954j, such as embodiments having three
or more equally (or non-equally) spaced ears. Still further, yet
other embodiments contemplate head planform shapes 952 in which the
passageways 954f and 954g are at least partly located and
integrated within the outer diameter of the circular planform, and
further those embodiments in which the passages 954e and 954f are
located entirely within the cylindrical planform shape.
[0159] Passageways 954e and 954f are adapted and configured to
permit the unrestrained passage therethrough of the 2 or more
strands of a single continuous (or endless) loop of tethering
material. The end of the loop and the strands of the loop are
provided to the entrance 954a of the passageways, and leave the
passageway through exit 954b (referring to FIG. 51). It is
understood that the terms entrance and exit are used for
convenience, and that the loop and strands can be entered or exited
through either side. Referring to FIG. 9, it can be seen that the
shape 952 of head 950 is symmetric about the two planes 952g and
952h as shown. However, other embodiments of the present invention
contemplate shapes of tethering heads that have only a single plane
of symmetry, or no symmetry at all. In such embodiments, one of the
entrance and exit may have one or more distinctly different
features than the other of the entrance or exit.
[0160] FIGS. 56-61 show various views of a vertebral tethering
member 1030 according to another embodiment of the present
invention. Tethering member 1030 includes a separate tethering head
X50c and separate means 40 for connecting the head to a vertebrae.
Tethering head 1050c includes one or more peripheral grooves 1064
extending around the planform shape 1052 of the head. In the
embodiment shown, connecting means 1040 is an anchoring screw 1044
that includes a plurality of threads 1044c on a shaft 1044a.
[0161] In some embodiments, a tethering member 1030 comprises a
two-piece assembly of separate components, similar to that
discussed with regards to tethering member 930. Referring to FIG.
57, it can be seen that connecting means 1040 includes a head 1047
attached to a shaft 1044a that has a plurality of bone-engaging
threads 1044c. Head 1047 preferably incorporates a driving feature
1047a that receives a tool operated by the user, through which a
torque can be applied to connecting means 1040.
[0162] Referring to FIGS. 57 and 60, it can be seen that head 1050a
includes a through aperture that receives therein the head and
shaft of connecting means 1040. The through aperture includes a
first, larger cylindrical well 1052k that slidably receives the
outer surface of head 1047. A second, smaller diameter aperture
1052l that extends the rest of the way through the bottom surface
of head 1050a. Preferably, either one of these cylindrical surfaces
1052k or 1052l are close-fitting to the corresponding outer
diameter of anchoring means 1040, with the other of cylindrical
well 1052k or aperture 1052l being a clearance fit.
[0163] Separating the two inner diameters is a compression surface
1052i that abuts against a compression surface 1047b of head 1047.
When torque is applied to connecting means 1040, the two
compression surfaces come into contact, and connecting means 1040
pulls head 1050a into contact with the vertebra.
[0164] With this separation of the anchoring means from the
tethering head, it is possible for the user to provide any angular
orientation to the tethering head, with such angular orientation
being maintained while connecting means 1040 is rotated and
tightened. In some embodiments, the frictional interface between
compression surfaces 1052i and 1047b may be coated to provide
desirable characteristics. As one example, one or more of the
surfaces can be coated with a low friction substance.
[0165] In yet another embodiment shown in FIG. 61, the connecting
means 1040 can include a cannula adapted and configured for a
surgical tool such as a guide wire or guide pin. In some
embodiments, the installation of tethering member 1030 may be
facilitated by the use of one or more tools to provide accurate
location of member 1030. As one example, the surgeon can determine
where best to locate the separate tethering head 1050a. Once the
location is established, a tool (not shown) having a cross
sectional shape similar to that of the head and neck of connecting
means 1040 can be placed within the well 1052k. A small central
hole within the tool then provides guidance for another tool, such
as a drill or a pin, which can be placed through the central hole
of the tool. The surgeon can use this tool to accurately locate the
hole, and then using the same tool, or another different tool,
provide guidance for a drill that creates the hole for coupling to
the threads 1044c.
[0166] Vertebral tethering member 1030 includes a tethering head
1050c adapted and configured for looping connection to a flexible
tether or suture. Referring to FIG. 56, it can be seen that a
tethering head X50c preferably includes at least one peripheral
groove 1064 that extends around the smooth outer surface X52d of
head X50c. In one embodiment, this groove is recessed into the
periphery, with the inner wall 1054d of the groove being smoothly
contoured and rounded for minimal abrasion with a suture loop
placed within the groove. In one embodiment, as shown in FIG. 56,
the inner wall 1054d has a semi-circular shape, although other
embodiments of the present invention contemplate smoothly contoured
and rounded walls of any shape, including walls having elliptical
cross sections and parabolic cross sections as examples.
[0167] Preferably, the groove includes a top and bottom pair of
walls 1054h and 1054i, respectively that, combined with the
innermost wall 1054d, form the suture loop passageway 1054.
Preferably and similar to the passageway of heads 250c and 350c,
this passageway has a width 1064c greater than the unstressed
diameter of the suture material, as well as a depth 1064d greater
than the unstressed diameter of the suture material. By having
groove dimensions greater than the unstressed diameter, the
physician will easily wrap the unstressed loop around and into
passageway 1054, and preferably without the need to push or force
the suture material into the groove. However, yet other embodiments
of the present invention contemplate a groove 1064c in which the
unstressed material fits tightly and securely within the
groove.
[0168] The top and bottom surfaces 1054h and 1054i, combined with
the depth 1064d of passageway 1054, result in the implanted suture
remaining securely within the groove, and not escaping the groove
even if the tension on the suture is slightly relieved. The
overhang of the top and bottom walls 1054h and 1054i also provide
protection to the suture loop within groove 1054 from abrasion from
other nearby features.
[0169] FIGS. 56, 60, and 61 show that in some embodiments head
1050c includes a pair of spaced apart grooves, similar to that
shown and described for tethering member 330. Preferably, these
grooves are spaced apart vertically from the underside, bone
contacting surface 1052e. Member 1030 permits a single tethering
member to apply tension in two different directions, each direction
being provided by a different suture loop.
[0170] FIGS. 58 and 59 show top and bottom views, respectively, of
tethering member 1030. Tethering member 1030 includes a central
driving feature 1052c for applying torque to the tethering member.
Further, both tethering members permit a variety of suture approach
directions 26c, similar to that shown with FIG. 21. The strands of
the suture can exit radially outwardly in any direction. Still
further, a strand (and not a complete loop) can be wrapped part way
around the groove, and depart (or approach) a head X50c
tangentially to the groove, as expressed by the arrow 26c of FIG.
21 shown at about the three o'clock position. It is understood that
the tethering member 1030, as discussed above, is adapted and
configured to provide connection to two different suture loops,
each approaching in two different directions, and in any of the
manners discussed with regard to tether member 230.
[0171] FIGS. 62-71 show various views of a vertebral tethering
member 1130 according to another embodiment of the present
invention. Tethering member 1130 includes a tethering head X50b and
means 40 for connecting the head to a vertebrae. Similar to members
930 and 1030 previously discussed, tethering member 1130 is
preferably an assembly of two separate components, a connecting
means 1140 and a tethering head 1150b.
[0172] Referring to FIGS. 63 and 65, it can be seen that the head
1147 preferably includes three distinct outer diameters of
decreasing size. The smallest diameter is adapted and configured to
be received within a through aperture of head 1150b. A larger,
intermediate outer diameter is received within a well 1152k of the
tethering head, and preferably provides location of head 1147
relative to head 1150b (the larger and smaller outer diameters
being clearance diameters creating a small circumferential gap).
Referring to FIG. 65, this intermediate diameter of the head 1147
preferably includes a compression surface 1147b that, after
assembly, presses against an opposite compression surface 1152i of
head 1150b. The coupling and reception of the intermediate and
smallest diameters of head 1147 within head 1150b is similar to the
manner described previously for tethering members 930 and 1030.
[0173] Head 1147 includes a largest diameter having an undersurface
1147c that provides the top enclosure for passageways 1154e and
1154f. Referring to FIGS. 65 and 66, it can be seen that three
sides of the passageways 1154 are preferably formed within head
1150b. A loop of suture material can be placed around either of the
securement posts 1174f or 1174g, and preferably placed within the
semi-circular passageways 1154f and 1154e. Once the loops are
placed within these open passageways 1154, the securement of
connecting means 1140 to the vertebrae places the underside 1147c
of the head on top of the passageways, thus completing the
enclosure of the passageways.
[0174] As seen in FIG. 64, the tether material is looped or hitched
around the passageway 1154, extending out of the passageway.
Preferably, the securement of connecting means 40 to the bone does
not pinch or compress or otherwise prevent sliding movement of the
tether material 24. Referring to FIG. 71, a variation of tethering
member 1130 includes a connecting means 40 that has a central
cannula 1144e that facilitates use of a separate tool (not shown)
for accurate location of tethering member 1130.
[0175] Various aspects of different embodiments of the present
invention are expressed in paragraphs X1, X2, X3, X4, X5, X6, X7,
X8, X9, X10, X11, and X12 as follows:
[0176] X1. Another aspect of the present invention pertains to a
member for connection to a bone. The member preferably includes a
head. The member preferably includes means for connecting the head
to a bone; and means for coupling the head to a flexible material,
wherein the connecting means and the head are separate devices.
[0177] X2. Yet another aspect of the present invention pertains to
a member for tethered connection to a bone. The member preferably
includes a bone connecting member, and a tethering head attached to
the bone connecting member, the tethering head including at least
one passageway extending in the head; the passageway being adapted
and configured to accept therein a flexible tether, the tethering
head including a slot extending across the top surface of the
tethering head, the slot providing through access to the
passageway, the passageway having internal threads. The member
preferably includes a threaded member adapted and configured to be
threadably received within the slot.
[0178] X3. Still another aspect of the present invention pertains
to a member for tethered connection to a bone. The member
preferably includes a bone connecting member and a tethering head
independent of the bone connecting member, the tethering head
including a bone contacting surface; the tethering head being
adapted and configured for joining to the bone by the bone
connecting member; such that connection of the bone connecting
member to a bone places the bone contacting surface in contact with
the bone.
[0179] X4. Yet another aspect of the present invention pertains to
a member for tethered connection to a bone. The member preferably
includes a bone connecting member and, and a tethering head
disconnectable from the bone connecting member, the head including
being adapted and configured to accept therein a flexible tether,
the passageway being externally accessible. The member preferably
includes a cover adapted and configured to cover the passageway and
the external access
[0180] X5. One aspect of the present invention pertains to a member
for connection to a bone. The member preferably includes a head and
means for connecting the head to a bone. The member preferably
includes means for coupling the head to a flexible material.
[0181] X6. Another aspect of the present invention pertains to a
member for tethered connection to a bone. The member preferably
includes a bone connecting member adapted and configured for
connection with a bone. The member preferably includes a head
attached to the bone connecting member, the head at least one
passageway extending across the head; the passageway being adapted
and configured to accept therein a corresponding tether, the
passageway having an entrance on one side of the head and an exit
on the opposing side of the head, the passageway being enclosed
from the top surface of the head.
[0182] X7. Yet another aspect of the present invention pertains to
a member for tethered connection to a bone. The member preferably
includes a bone connecting member adapted and configured for
connection with a bone. The member preferably includes a head
attached to the bone connecting member, the head including at least
one securement post each adapted and configured for connection to a
loop of a flexible tether, the post including a groove sized to
accept therein a tether loop.
[0183] X8. Still another aspect of the present invention pertains
to a member for tethered connection to a bone. The member
preferably includes a bone connecting member adapted and configured
for connection with a bone. The member preferably includes a head
attached to the bone connecting member, the head including at least
one peripheral groove adapted and configured for connection to a
separate loop of flexible tether, the head having a top surface
furthest away from the vertebrae, wherein the at least one
peripheral groove is between the top surface and the bone.
[0184] X9. Another aspect of the present invention pertains to a
method for tethering of vertebrae. The method preferably includes
attaching a first tethering head to a first bone. The method
preferably includes attaching a second tethering head to the first
bone spaced apart from the first tethering head. The method
preferably includes attaching a third tethering head to a second
bone. The method preferably includes looping one end of a first
flexible tether in a first groove in the first tethering head. The
method preferably includes looping one end of a second flexible
tether in a second groove in the second tethering head. The method
preferably includes connecting the first bone to the second bone by
looping the other end of the first flexible tether within a groove
in the third tethering head, and connecting the first bone to the
second bone by looping the other end of the second flexible tether
within a groove in the third tethering head.
[0185] X10. Yet another aspect of the present invention pertains to
a method for tethering of vertebrae. The method preferably includes
attaching a first tethering head to a first bone. The method
preferably includes attaching a second tethering head to a second
bone. The method preferably includes looping a flexible tether in a
first groove extending around the periphery of the first tethering
head. The method preferably pertains to extending the looped tether
from the first tethering head to the second tethering head; and
passing the extension of the looped tether though an aperture in
the second tethering head.
[0186] X11. Still another aspect of the present invention pertains
to a device for making a flexible connection between bones. The
device preferably includes a bone connecting member adapted and
configured for connection with a bone, the bone connecting member
including an alignment feature. The device preferably includes a
separable receiver for a flexible connector, the receiver having a
body including a protrusion with a passageway for a flexible
connector and including a first central aperture adapted and
configured to receive therein the alignment feature. The device
preferably includes a central pocket that couples to the receiver,
the central pocket including a lateral aperture that permits
placement therethrough of the protrusion.
[0187] X12. Another aspect of the present invention pertains to a
member for making a flexible connection between bones. The member
preferably includes a connecting member having a first aligning
element. The member preferably includes a first separable receiver
for a flexible connector, the first receiver having a body
including a first protrusion and provisions for a flexible
connector. The member preferably includes a head having a pocket
that receives therein the first receiver, the pocket including a
first lateral aperture that permits placement therethrough of the
first protrusion, the head including a second aligning element
adapted and configured to couple with the first aligning element,
wherein placement of the first receiver within the central pocket
permits alignment of the first aligning element with the second
aligning element to capture the first and second separable
receivers between the head and the connecting member.
[0188] Yet other embodiments pertain to any of the previous
statements X1, X2, X3, X4, X5, X6, X7, X8, X9, X10, X11, or X12,
which are combined with one or more of the following other aspects.
It is also understood that any of the aforementioned X paragraphs
include listings of individual features that can be combined with
individual features of other X paragraphs.
[0189] Wherein said coupling means includes a groove extending
around the periphery of said head, the groove being adapted and
configured to contain the flexible material.
[0190] Wherein the flexible member has a diameter, and the width of
the groove is greater than the diameter, and the depth of the
groove is greater than the diameter.
[0191] Wherein said coupling means includes a pair of separated
grooves each extending around the periphery of said head, each
groove being adapted and configured to contain the flexible
material.
[0192] Wherein said shaft has an axis, and each groove is
substantially perpendicular to the axis.
[0193] Wherein said coupling means includes first and second
passageways each extending through the interior of said head, each
having an entrance for the flexible material and an exit for the
flexible material, each entrance and exit being on opposite sides
of said head, each of the passageways being smooth and
uninterrupted between the corresponding entrance and exit.
[0194] Wherein the first and second passageways have uninterrupted
side boundaries.
[0195] Wherein a portion of the first and second passageways
proximate to the neck of said shaft are smooth and continuous.
[0196] Wherein the portion of the first and second passageways does
not include a blind hole; or the first and second passageways are
open to the top surface of said head; or the first and second
passageways are enclosed relative to the top surface of said
head.
[0197] Wherein said coupling means includes first and second
passageways each have opposing lateral walls, each lateral wall
extending between a corresponding exit and entrance for that
passageway, and each lateral wall transitions to the exterior
surface of said head proximate to the respective exit or entrance
with a radius of curvature greater than ninety degrees.
[0198] Wherein said coupling means includes first and second
passageways each having an entrance for the flexible material and
an exit for the flexible material, each said passageway extending a
length from entrance to exit, said head has a maximum width, a
minimum width less than the maximum width, and the length of each
passageway is less than the minimum width.
[0199] Wherein said coupling means includes first and second
passageways each having an entrance for the flexible material and
an exit for the flexible material, each said passageway extending a
length from entrance to exit, said head has a maximum width, and
the length of each passageway is less than the maximum width.
[0200] Wherein said coupling means includes means for convexly
separating the first passageway from the second passageway.
[0201] Wherein said convex separating means includes a smooth bump
between the first and second passageways; or said convex separating
means includes a smooth ridge between the first and second
passageways.
[0202] Wherein the top of said head includes an open slot
permitting passage of the flexible material into each of the
passageways.
[0203] Wherein the top of head is closed between passageways, such
that a portion of flexible material passing through a passageway
cannot be lifted vertically out of the passageway.
[0204] Wherein the first and second passageways are substantially
parallel.
[0205] Wherein the first and second passageways combine in a
cross-sectional V-shape with the opened end of the V-shape being
directed toward the neck of said shaft.
[0206] Wherein said head has a maximum width greater than the outer
diameter of the threads; or said head has a width orthogonal to the
maximum width that is greater than the outer diameter of the
threads but less than the maximum width; or said head has a minimum
width orthogonal to the maximum width that is less than the maximum
width.
[0207] Wherein said shaft, said head, and said coupling means are
unitary.
[0208] Wherein the outer surfaces of said head are smooth.
[0209] Wherein said head has a non-circular outer peripheral shape
adapted and configured to receive a driving torque from a driving
tool having a complementary inner peripheral shape.
[0210] Wherein said head has a distal side adapted and configured
for resting on the bone when the anchor is fully inserted into the
bone.
[0211] Wherein said head has a distal side that is substantially
flat
[0212] Wherein said connecting means includes a shaft having
proximal and distal ends, the distal end including a tip adapted
and configured for entry into a hole in a bone, the proximal end
including a neck, said shaft including a plurality of threads
intermediate of the tip and the neck, the threads being adapted and
configured for connection with a vertebrae.
[0213] Wherein said connecting means includes a post adapted and
configured to connection to a vertebrae; or said connecting means
includes an adjustable loop adapted and configured for connection
around a vertebrae; said connecting means includes a hook adapted
and configured to connection to a vertebrae.
[0214] Whether the flexible material is a suture, tether, cord, or
wire.
[0215] Wherein the flexible material is fabricated from a polymeric
compound, or from a metal.
[0216] Wherein said head includes smoothly contouring walls
defining said first and second passageways, the walls being adapted
and configured to permit sliding movement of a tether against the
wall without abrasively damaging the tether.
[0217] Wherein each said passageway has a smooth elongated cross
section shape.
[0218] Wherein each first and second cross sectional shape is
elongated along a respective first or second axis, and the angle
included from the first axis to the second axis is more than about
ninety degrees and less than one hundred and twenty degrees.
[0219] Wherein each first and second cross sectional shape is
elongated along a respective first or second axis, and first and
second axes have a V shape with the open side of the V being
oriented toward said bone connecting member.
[0220] Wherein the apex of the V shape is within said head.
[0221] Wherein each said post has a maximum width, said head has a
minimum width, and the maximum width is less than the minimum
width.
[0222] Wherein said coupling means includes first and second
passageways each having an entrance for the flexible material and
an exit for the flexible material, each said passageway extending a
length from entrance to exit, said head has a maximum width, and
the length of each passageway is less than the maximum width.
[0223] Wherein the top surface of said head includes a central slot
having a width sized to permit passage therethrough of the flexible
tether. Wherein said head includes a smoothly contoured convex
lower surface that extends between said first and second posts.
[0224] Wherein each said post includes smoothly contouring walls
defining the respective groove, the walls being adapted and
configured to permit sliding movement of a tether against the wall
without abrasively damaging the tether.
[0225] Wherein said peripheral grooves are substantially parallel
to each other.
[0226] Wherein said head has a peripheral shape that is rounded,
circular, or oblong or elliptical.
[0227] Wherein the aperture includes two separated passageways and
wherein said passing includes guiding one side of the tether loop
within one passageway and guiding the other side of the tether loop
within the other passageway.
[0228] Which further comprises attaching a third tethering head to
a third bone, the second bone being located between the first bone
and the third bone, and looping the flexible tether passed through
the second tethering head in a third groove extending around the
periphery of the third tethering head.
[0229] Wherein the aperture includes two separated passageways and
wherein said passing includes lacing the tether loop within one
passageway and around a portion of the second tethering head.
[0230] Wherein the tether is a first tether, wherein the aperture
includes two separated passageways, the extension of the first
looped tether is within one passageway and around a portion of the
second tethered head, and which further comprises attaching a third
tethering head to a third bone, the second bone being located
between the first bone and the third bone; looping one end of a
second flexible tether within the other passageway and around a
different portion of the second tethered head, and looping the
other end of the second flexible tether in a third groove extending
around the periphery of the third tethering head.
[0231] Wherein the tether is a first tether, wherein the first
groove is a lower groove, the first tethering head including an
upper groove, and which further comprises attaching a third
tethering head to a third bone, looping a second flexible tether in
the upper groove extending around the periphery of the first
tethering head, extending the looped second tether from the first
tethering head to the third tethering head; and coupling the
extension of the looped tether to the third tethering head.
[0232] Wherein the tether is an endless loop.
[0233] Which further comprises attaching together the free ends of
a portion of flexible tether and creating an endless loop of tether
from the portion after said passing.
[0234] Which further comprises attaching together the free ends of
a portion of flexible tether and creating an endless loop of tether
from the portion before said wrapping.
[0235] Which further comprises attaching together the free ends of
a portion of flexible tether and creating an endless loop of tether
from the portion.
[0236] Wherein said separable receiver is a first separable
receiver, and which further comprises: a second separable receiver
for a flexible connector, said second receiver having a second body
including a second protrusion with a second passageway for a
flexible connector and including a third central aperture adapted
and configured to receive therein the alignment feature; wherein
the lateral aperture is a first lateral aperture and said head
includes a second lateral aperture spaced apart from the first
lateral aperture that permits placement therethrough of the second
protrusion; wherein connection of said bone connecting member to a
bone aligns said receiver and said head and captures said first
separable receiver and said second separable receiver within the
central pocket.
[0237] Wherein said first lateral aperture is angularly spaced
apart from said second lateral aperture by about ninety degrees or
less; or said first lateral aperture is angularly spaced apart from
said second lateral aperture by about ninety degrees or more.
[0238] Wherein said central pocket has an internal shape, the body
of said separable receiver has an external shape, and the external
shape is a close fit within the internal shape.
[0239] Wherein said alignment feature has an external shape, the
first central aperture has an internal shape, and the external
shape is a close fit within the internal shape.
[0240] Wherein said alignment feature has an external shape, the
second central aperture has an internal shape, and the external
shape is a close fit within the internal shape.
[0241] Wherein said head includes a bone contacting side that
includes a plurality of projections adapted and configured to
penetration into the bone.
[0242] Wherein said bone connecting member includes a head that
covers the central pocket or the top surface.
[0243] Wherein said bone connecting member includes a threaded
shaft having a lumen therethrough.
[0244] Wherein the first lateral aperture and said second lateral
aperture are spaced apart.
[0245] Wherein said connecting member is a threaded fastener
adapted and configured for connection to a bone.
[0246] Wherein said connecting member is a first connecting member
and one of said first connecting member or said head is adapted and
configured for connection to a bone connecting member.
[0247] Wherein the threaded member is a set screw.
[0248] Wherein the threaded member has a top surface, said head has
a top surface and when fully engaged in the slot the top surface of
said threaded member is at or below the top surface of said
head.
[0249] Wherein said bone connecting member includes a plate, a
threaded shaft; or an anchoring head.
[0250] Wherein said bone connecting member includes a threaded
shaft and said tethering head includes an aperture extending from
the top surface of said tethering head through the bone contacting
surface, the aperture being sized to accept therethrough the
shaft.
[0251] Wherein said bone connecting member includes an anchoring
head and said tethering head includes a contacting surface, and
connection of said bone connecting member to the bone places the
anchoring head in compression against the contacting surface.
[0252] Wherein said head has a smooth outer surface and a
projection extending from the outer surface, and said passageway
extends at least partly through the projection.
[0253] Wherein said cover and said bone connecting member are
integral.
[0254] Wherein the entrance and exit are located proximate to each
other such that the flexible tether loops around a portion of said
tethering head.
[0255] Wherein said tethering head includes a bone contacting
surface, the bone contacting surface being in contact with the bone
when said bone connecting member is connected to a bone, said
passageway being between the bone contacting surface and said
cover.
[0256] While the inventions have been illustrated and described in
detail in the drawings and foregoing description, the same is to be
considered as illustrative and not restrictive in character, it
being understood that only certain embodiments have been shown and
described and that all changes and modifications that come within
the spirit of the invention are desired to be protected.
* * * * *