U.S. patent application number 16/701845 was filed with the patent office on 2020-06-04 for eyelet interference screw and methods of use.
The applicant listed for this patent is International Life Sciences LLC d/b/a Artelon, International Life Sciences LLC d/b/a Artelon. Invention is credited to Jantzen Cole, Aaron Smith, Chase Thornburg.
Application Number | 20200170782 16/701845 |
Document ID | / |
Family ID | 70849640 |
Filed Date | 2020-06-04 |
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United States Patent
Application |
20200170782 |
Kind Code |
A1 |
Smith; Aaron ; et
al. |
June 4, 2020 |
EYELET INTERFERENCE SCREW AND METHODS OF USE
Abstract
Provided herein are systems, methods and apparatuses for an
eyelet interference screw and affixation of an implant to tissue
employing the eyelet interference screw.
Inventors: |
Smith; Aaron; (Marietta,
GA) ; Thornburg; Chase; (Cumming, GA) ; Cole;
Jantzen; (Woodstock, GA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
International Life Sciences LLC d/b/a Artelon |
Marietta |
GA |
US |
|
|
Family ID: |
70849640 |
Appl. No.: |
16/701845 |
Filed: |
December 3, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62774453 |
Dec 3, 2018 |
|
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|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/0409 20130101;
A61B 17/0401 20130101; A61B 17/1615 20130101; A61B 2017/0414
20130101; A61F 2002/0081 20130101; A61B 2017/044 20130101; A61F
2/0811 20130101; A61F 2002/0852 20130101; A61F 2002/0888 20130101;
A61F 2002/0829 20130101 |
International
Class: |
A61F 2/08 20060101
A61F002/08; A61B 17/04 20060101 A61B017/04 |
Claims
1. An eyelet interference screw, comprising: a first end and a
second end and a longitudinal axis extending from the first end to
the second end; an eyelet member having an eyelet opening disposed
at the first end; a threaded member disposed at the second end; and
wherein the first end and the second end are operably coupled to
each other such that the first end is rotatable about the
longitudinal axis independent of the second end.
2. The eyelet interference screw of claim 1, wherein the threaded
member further comprises an unthreaded section and a threaded
section.
3. The eyelet interference screw of claim 1, wherein the eyelet
member further includes a connector projection and the second end
further includes a central bore, wherein the central bore is
configured to receive the connector projection therein.
4. The eyelet interference screw of claim 3, wherein the connector
projection further comprises at least two legs and a slot between
the at least two legs, each of the at least two legs terminating in
a pawl.
5. The eyelet interference screw of claim 3, wherein the eyelet
member further includes a first section having a curved leading
surface and a second section adjacent the connector projection and
from which the connector projection extends.
6. The eyelet interference screw of claim 4, wherein each of the at
least two legs are configured to flex toward the slot.
7. The eyelet interference screw of claim 5, wherein the second
section of the eyelet member further includes a taper along the
longitudinal axis of the eyelet interference screw.
8. The eyelet interference screw of claim 1, wherein the threaded
member further comprises at least one external protuberance
selected from the group of continuous helical thread, discontinuous
helical threads, and circumferential ring.
9. The eyelet interference screw of claim 4, wherein the central
bore further comprises a first bore section and a second bore
section, the first bore section being configured to receive the
connector projection therein.
10. The eyelet interference screw of claim 9, wherein the second
bore section has a diameter relatively larger than a diameter of
the first bore section and a flange positioned at a junction
between the first bore section and the second bore section, wherein
the pawl of the at least two legs pass through the first bore
section and into the second bore section and seat against the
flange.
11. The eyelet interference screw of claim 9, wherein the first
bore section further includes a receiving opening configured to
receive the connector projection therethrough.
12. The eyelet interference screw of claim 11, wherein the
receiving opening is tapered toward the first bore section.
13. The eyelet interference screw of claim 9, wherein the second
bore section further includes a driver coupling opening configured
to couple a driver member thereto.
14. The eyelet interference screw of claim 13, wherein the second
bore section further includes a plurality of splines along an inner
surface of the second bore section, the splines being configured to
engage the driver member within the second bore section.
15. The eyelet interference screw of claim 2, wherein a first bore
section passes through the unthreaded section of the threaded
member and a second bore section passes through the threaded
section of the threaded member.
16. An eyelet interference screw, comprising: an eyelet member
positioned at a first end or the eyelet interference screw, the
eyelet member having an eyelet opening passing through the eyelet
member; a threaded member positioned at a second end or the eyelet
interference screw; and wherein the eyelet member and the threaded
member are coupled to each other.
17. The eyelet interference screw of claim 16, wherein the eyelet
member and the threaded member are fixed relative to each
other.
18. The eyelet interference screw of claim 16, wherein the eyelet
member is independently rotatable relative to the threaded
member.
19. The eyelet interference screw of claim 18, wherein the eyelet
member further includes a connector projection and the second end
further includes a central bore, wherein the central bore is
configured to receive the connector projection therein.
20. The eyelet interference screw of claim 19, wherein the
connector projection further comprises at least two legs and a slot
between the at least two legs, each of the at least two legs
terminating in a pawl.
21. The eyelet interference screw of claim 16, wherein the threaded
member further comprises at least one external protuberance
selected from the group of continuous helical thread, discontinuous
helical threads, and circumferential ring.
22. The eyelet interference screw of claim 19, wherein the central
bore further comprises a first bore section and a second bore
section, the first bore section being configured to receive the
connector projection therein.
23. The eyelet interference screw of claim 22, wherein the second
bore section has a diameter relatively larger than a diameter of
the first bore section and a flange positioned at a junction
between the first bore section and the second bore section, wherein
the pawl of the at least two legs pass through the first bore
section and into the second bore section and seat against the
flange.
24. The eyelet interference screw of claim 22, wherein the first
bore section further includes a receiving opening configured to
receive the connector projection therethrough.
25. The eyelet interference screw of claim 24, wherein the
receiving opening is tapered toward the first bore section.
26. The eyelet interference screw of claim 24, wherein the second
bore section further includes a driver coupling opening configured
to couple a driver member thereto.
27. The eyelet interference screw of claim 26, wherein the second
bore section further includes a plurality of splines along an inner
surface of the second bore section, the splines being configured to
engage the driver member within the second bore section.
28. The eyelet interference screw of claim 22, wherein a first bore
section passes through the unthreaded section of the threaded
member and a second bore section passes through the threaded
section of the threaded member.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims priority to U.S. provisional
application Ser. No. 62/774,453, filed Dec. 3, 2018, which is
hereby incorporated by reference in its entirety.
BACKGROUND
[0002] The present invention relates generally to medical implants,
medical kits, medical implant components or medical instruments.
More particularly, the present invention relates to affixation
devices configured to attach tissue, such as ligaments or tendons,
to bone or muscle during surgical repair procedures.
[0003] Medical implants and instruments that are to be used in the
human body and be in direct contact with the human tissues need to
fulfill several requirements. Surgical treatment of injury to soft
tissues of the musculoskeletal system of mammals caused by trauma,
sudden overload, fatigue, disease or other degenerative medical
condition may in some cases benefit from or even require structural
support to start healing.
[0004] The present invention attempts to solve these problems as
well as others.
SUMMARY OF THE INVENTION
[0005] Provided herein are systems, methods and apparatuses for an
eyelet interference screw. An eyelet interference screw is
disclosed herein and generally comprises a first end and a second
end with a longitudinal axis extending from the first end to the
second end. The first end is an eyelet member having an eyelet
opening passing there through, and the second end is a threaded
member configured to rotatably couple to the eyelet member, such
that the eyelet member and the threaded member are able to rotate
independently of each other about the longitudinal axis of the
eyelet interference screw.
[0006] A method of implanting an eyelet interference screw is
disclosed and comprises generally the steps of: forming a blind
hole in the bone to which tissue is to be attached; loading an
eyelet interference screw on a driver device, wherein a first end
of an implant is attached to the opening on the eyelet interference
screw; aligning the opening of the eyelet interference screw with
the hole formed in the bone; seating the eyelet of the eyelet
interference screw into the bone; rotating the driver to seat the
eyelet interference screw into the bone until the proximal end of
the eyelet interference screw is substantially flush with a surface
of the bone and the implant is at least partially exposed outside
the surface of the bone. A second end of an implant is then affixed
in a manner like the first end of the implant.
[0007] The methods, systems, and apparatuses are set forth in part
in the description which follows, and in part will be obvious from
the description, or can be learned by practice of the methods,
apparatuses, and systems. The advantages of the methods,
apparatuses, and systems will be realized and attained by means of
the elements and combinations particularly pointed out in the
appended claims. It is to be understood that both the foregoing
general description and the following detailed description are
exemplary and explanatory only and are not restrictive of the
methods, apparatuses, and systems, as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] In the accompanying figures, like elements are identified by
like reference numerals among the several preferred embodiments of
the present invention.
[0009] FIG. 1 is a side elevational view of an eyelet interference
screw in accordance with an embodiment of the present
invention.
[0010] FIG. 2 is a partial cross-sectional view taken along line
2-2 of FIG. 1.
[0011] FIG. 3 is an exploded perspective view of an eyelet
interference screw in accordance with the present invention.
[0012] FIG. 4A is a side elevational view of an eyelet member in
accordance with an embodiment of the present invention.
[0013] FIG. 4B is a side elevational view of an eyelet member in
accordance with an alternative embodiment of the present
invention.
[0014] FIG. 5 is an end view taken along arrow 5 of FIG. 4B.
[0015] FIG. 6 is an end view taken along arrow 6 of FIG. 4B.
[0016] FIG. 7 is a perspective view of a threaded member of the
eyelet interference screw in accordance with one embodiment
thereof.
[0017] FIG. 8 is a cross-sectional view taken along line 8-8 of
FIG. 7.
[0018] FIG. 9 is an end elevational view taken along arrow 9 of
FIG. 7.
[0019] FIG. 10 is an end elevational view taken along arrow 10 of
FIG. 7.
[0020] FIG. 11 is fragmentary cross-sectional view illustrating
engagement of the eyelet portion with the threaded member of an
eyelet interference screw in accordance with an embodiment of the
present invention.
[0021] FIG. 12 is a perspective exploded view of an alternative
embodiment of an eyelet interference screw in accordance with the
present invention.
[0022] FIG. 13A is a side elevational view of a loading device for
implanting the inventive eyelet interference screw into bone in
accordance with the present invention.
[0023] FIG. 13B is a side elevational view the loading device for
implanting the inventive eyelet interference screw diagrammatically
illustrating the eyelet interference screw being implanted into
bone in accordance with the present invention.
[0024] FIG. 13C is a side elevational view of the loading device
for implanting the inventive eyelet interference screw
diagrammatically illustrating the eyelet interference screw fully
implanted into bone in accordance with the present invention.
[0025] FIG. 13D is a diagrammatic view of a bone having the
inventive eyelet interference screw implanted in the bone and a
tissue repair implant extending from the eyelet interference screw
external to the bone.
[0026] FIG. 14 is a side view of a bone drill bit employed in the
method of the present invention to form a blind hole in a bone into
which the inventive eyelet interference screw is placed.
[0027] FIG. 15 is a side view of a tap device implanting the eyelet
interference screw in accordance with the method of the present
invention.
[0028] FIG. 16 is a perspective of a drill guide which may be
employed to guide the bone drill and limit a depth of penetration
of the bone drill into the bone in accordance with the method of
the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0029] The foregoing and other features and advantages of the
invention are apparent from the following detailed description of
exemplary embodiments, read in conjunction with the accompanying
drawings. The detailed description and drawings are merely
illustrative of the invention rather than limiting, the scope of
the invention being defined by the appended claims and equivalents
thereof.
[0030] Embodiments of the invention will be described with
reference to the Figures, wherein like numerals reflect like
elements throughout. The terminology used in the description
presented herein is not intended to be interpreted in any limited
or restrictive way, simply because it is being utilized in
conjunction with detailed description of certain specific
embodiments of the invention. Furthermore, embodiments of the
invention may include several novel features, no single one of
which is solely responsible for its desirable attributes or which
is essential to practicing the invention described herein. The
words proximal and distal are applied herein to denote specific
ends of components of the instrument described herein. A proximal
end refers to the end of an instrument nearer to an operator of the
instrument when the instrument is being used. A distal end refers
to the end of a component further from the operator and extending
towards the surgical area of a patient and/or the implant.
[0031] This application is intended to cover any variations, uses
or adaptations of the invention following, in general, the
principles of the invention, and including such. The foregoing and
other features and advantages of the invention will become more
apparent from the following detailed description of the exemplary
embodiments, read in conjunction with the accompanying drawings.
The detailed description and drawings are merely illustrative of
the invention rather than limiting, the scope of the invention
being defined by the appended claims and equivalents thereof.
[0032] For purposes of clarity, the following terms used in this
patent application will have the following meanings:
[0033] The terminology used herein is for the purpose of describing
example embodiments only and is not intended to be limiting. As
used herein, the singular forms "a," "an," and "the" may be
intended to include the plural forms as well, unless the context
clearly indicates otherwise. The terms "comprises," "comprising,"
"including," and "having," are inclusive and therefore specify the
presence of stated features, integers, steps, operations, elements,
and/or components, but do not preclude the presence or addition of
one or more other features, integers, steps, operations, elements,
components, and/or groups thereof. The method steps, processes, and
operations described herein are not to be construed as necessarily
requiring their performance in the order discussed or illustrated,
unless specifically identified as an order of performance. It is
also to be understood that additional or alternative steps may be
employed.
[0034] When an element or layer is referred to as being "on,"
"engaged," "connected," or "coupled" to or with another element, it
may be directly on, engaged, connected or coupled to the other
element or layer, or intervening elements or layers may be present.
In contrast, when an element is referred to as being "directly on,"
"directly engaged to," "directly connected to," or "directly
coupled to" or with another element or layer, there may be no
intervening elements or layers present. Other words used to
describe the relationship between elements should be interpreted in
a like fashion (e.g., "between" versus "directly between."
"adjacent" versus "directly adjacent." etc.) As used herein, the
term "and/or" includes any and all combinations of one or more of
the associated listed items.
[0035] Although the terms first, second, third, etc. may be used
herein to describe various elements, components, regions, layers
and/or sections, these elements, components, regions, layers and/or
sections should not be limited by these terms. These terms may be
only used to distinguish one element, component, region, layer or
section from another region, layer or section. Terms such as
"first," "second," and other numerical terms when used herein do
not imply a sequence or order unless clearly indicated by the
context. Thus, a first element, component, region, layer or section
discussed below could be termed a second element, component,
region, layer or section without departing from the teachings of
the example embodiments.
[0036] Spatially relative terms, such as "inner," "outer,"
"beneath," "below," "lower," "above," "upper," and the like, may be
used herein for ease of description to describe one element or
feature's relationship to another element(s) or feature(s) as
illustrated in the figures. Spatially relative terms may be
intended to encompass different orientations of the device in use
or operation in addition to the orientation depicted in the
figures. For example, if the device in the figures is turned over,
elements described as "below", or "beneath" other elements or
features would then be oriented "above" the other elements or
features. Thus, the example term "below" can encompass both an
orientation of above and below. The device may be otherwise
oriented (rotated 90 degrees or at other orientations) and the
spatially relative descriptors used herein interpreted
accordingly.
[0037] "Substantially" is intended to mean a quantity, property, or
value that is present to a great or significant extent and less
than, more than or equal to totally. For example, substantially
vertical may bean less than greater than or equal to completely
vertical.
[0038] "About" is intended to mean a quantity, property, or value
that is present at +10%. Throughout this disclosure, the numerical
values represent approximate measures or limits to ranges to
encompass minor deviations from the given values and embodiments
having about the value mentioned as well as those having exactly
the value mentioned. Other than in the working examples provided at
the end of the detailed description, all numerical values of
parameters (e.g., of quantities or conditions) in this
specification, including the appended claims, are to be understood
as being modified in all instances by the term "about" whether or
not "about" actually appears before the numerical value. "About"
indicates that the stated numerical value allows some slight
imprecision (with some approach to exactness in the value;
approximately or reasonably close to the value; nearly). If the
imprecision provided by "about" is not otherwise understood in the
art with this ordinary meaning, then "about" as used herein
indicates at least variations that may arise from ordinary methods
of measuring and using such parameters. In addition, disclosure of
ranges includes disclosure of all values and further divided ranges
within the entire range, including endpoints given for the
ranges.
[0039] The use of the terms "a" and "an" and "the" and similar
referents in the context of describing the invention are to be
construed to cover both the singular and the plural, unless
otherwise indicated herein or clearly contradicted by context. It
will be further understood that the terms "comprises,"
"comprising," "includes," and/or "including," when used herein,
specify the presence of stated features, integers, steps,
operations, elements, and/or components, but do not preclude the
presence or addition of one or more other features, integers,
steps, operations, elements, components, and/or groups thereof.
[0040] Recitation of ranges of values herein are merely intended to
serve as a shorthand method of referring individually to each
separate value falling within the recited range, unless otherwise
indicated herein, and each separate value is incorporated into the
specification as if it were individually recited herein.
[0041] References to "one embodiment," "an embodiment," "example
embodiment," "various embodiments," etc., may indicate that the
embodiment(s) of the invention so described may include a
particular feature, structure, or characteristic, but not every
embodiment necessarily includes the particular feature, structure,
or characteristic. Further, repeated use of the phrase "in one
embodiment," or "in an exemplary embodiment," do not necessarily
refer to the same embodiment, although they may.
[0042] As used herein the term "method" refers to manners, means,
techniques and procedures for accomplishing a given task including,
but not limited to, those manners, means, techniques and procedures
either known to, or readily developed from known manners, means,
techniques and procedures by practitioners of the chemical,
pharmacological, biological, biochemical and medical arts. Unless
otherwise expressly stated, it is in no way intended that any
method or aspect set forth herein be construed as requiring that
its steps be performed in a specific order. Accordingly, where a
method claim does not specifically state in the claims or
descriptions that the steps are to be limited to a specific order,
it is no way intended that an order be inferred, in any respect.
This holds for any possible non-express basis for interpretation,
including matters of logic with respect to arrangement of steps or
operational flow, plain meaning derived from grammatical
organization or punctuation, or the number or type of aspects
described in the specification.
[0043] As used herein, the terms "blind hole" and "hole" when used
to describe a hole drilled into bone tissue refers to a hold that
is open to the bone tissue at one end, does not pass through the
bone tissue and is closed by bone tissue at an opposing end of the
hole.
[0044] As used herein, the terms "thread," "threads," or "threaded"
is intended to include protuberances forming a continuous helical
thread, discontinuous helical threads, or circumferential ring
structures, unless the context expresses unequivocally
otherwise.
[0045] The inventive eyelet interference screw may be used to treat
a tendon or ligament repair. The instrument may include an
implantation device to secure the implant into bone or a tissue,
such as a bone screw, staple, and the like. Sutures may further
secure the implant to the ligament, tendon, or bone screw. Surgical
kits may be produced containing elements necessary for treating
and/or repairing tendons and ligaments with the implant. Such a kit
may include various configurations of the implant. One or more
surgical tools used in tendon and/or ligament repair surgery are
also advantageously provided in such kits. The surgical kits may
treat the following tissue, ligaments, and tendons including, but
are not limited to a lateral ankle anterior talofibular ligament
(ATFL); calcaneofibular ligament (CFL); medial collateral ligament
(MCL), plantar plate, Achilles tendon, peroneal tendon, medial
ankle (spring ligament, deltoid ligament), syndesmosis, open
rotator cuff, acromioclavicular joint kit (AC Joint), and the
anterior collateral ligament (ACL).
[0046] Generally speaking, inventive eyelet interference screw may
be used to attach a tendon or ligament repair implant, which may
include the materials, configuration, or properties as described in
U.S. Pat. Nos. 6,210,441, 6,627,258, 7,037,342, 9,427,494,
10,155,067, and/or U.S. Patent Application Publications US
2011/0015735 or US 2018-0230628, herein incorporated by reference
in their entries. The repair implant, itself, may be a FLEXBAND,
FLEXBAND PLUS or FLEXPATCH (Artelon, Marietta, Ga. USA). Such types
of repair implants may be referred to synonymously herein as a mesh
strip.
[0047] Referring now to FIGS. 1-3 the eyelet interference screw 100
generally comprises an externally threaded member 109 and an eyelet
member portion 111. The eyelet interference screw 100 has a length
L1 and a longitudinal axis 101. The eyelet member portion 111
generally comprises an eyelet member 120 having an eyelet opening
150 passing through the eyelet member 120, and a seating projection
108. Seating projection 108 projects outwardly from the eyelet
member 120 along the longitudinal axis 101. The eyelet member 120
and the eyelet opening 150 may collectively or independently be
configured to any desirable shape, including, without limitation,
generally circular, generally elliptical, generally oval, generally
square, or generally rectangular. The seating projection 108 is,
according to one embodiment, a generally cylindrical member, and
according to other embodiments, may have alternative
configurations, such as cubic, rectilinear, polygonal or the like.
The seating projection will preferably have smaller cross-sectional
dimension than the eyelet member 120 and will preferably have a
tapered section 107 extending from a relatively larger aspect at
its junction with the eyelet member 120 to a relatively smaller
aspect at its junction with the seating projection 108.
[0048] As further illustrated in FIGS. 1-3, the threaded member 109
of the eyelet interference screw 100 includes a central core member
140 having at least one protuberance, for example, external helical
thread 148 surrounding at least a longitudinal aspect of the
central core member 140. The central core member 140 is a generally
tubular member having a central bore 190 passing through a
longitudinal axis thereof. Central bore 190 preferably has a first
end section 191 having an inner diameter ID1 and terminating in a
receiving opening 196 which receives the eyelet member 120
therethrough. Central bore 190 also has a second end section 193
having inner diameter ID2, where ID2 is relatively larger than ID1
A flange 113 is provided in the central core member 140 at the
transition between ID1 and ID2 of the central bore 190.
[0049] To secure the seating projection 108 within the central bore
190 of the central core member 140, multiple configurations may be
employed that couple the eyelet member portion 111 to the threaded
member 109 and allow rotation of the eyelet member portion 111
relative to the threaded member 109. Without intending to be
limited to the specific embodiment illustrated, one example of a
suitable one-way coupling is to provide split legs 117 extending
from the seating projection 108, each of the split legs 117 having
at least one pawl 115. In this configuration, each of the split
legs 117 act as a spring and are compressed as the seating
projection 108 is passed into and through the proximal section of
the central bore 190. Upon entering the enlarged distal section of
the central bore 190, the split legs 117 return to their normal
non-tensioned position extending radially outward and radially
extending pawl engages the flange 113 within the central bore 190.
In this manner, the eyelet member portion 111 is coupled to the
threaded member.
[0050] According to one embodiment, the eyelet member portion 111
is configured to couple to and rotatably engage with the threaded
member 109 in such a manner that allows the threaded member 109 to
rotate about the longitudinal axis 101 when the threaded member 109
and the eyelet member portion 111 are engaged.
[0051] The eyelet member portion 111 may be rotatably coupled
within the proximal portion of central bore 190 and along the
longitudinal axis 101 of the eyelet interference screw 100. The
force required to rotate the eyelet member portion 111 may be
determined by the relative tolerances between the outer diameter of
the seating projection 108 and the ID1 and ID2 of the central bore.
Alternatively, there may be provided interference means for
limiting the rotational force needed to rotate the eyelet member
portion 111 relative to the seating projection 108. Such
alternative interference means may include, for example, a ratchet
mechanism, detents, or other interference mechanisms provided
within the central bore 190 to limit or control the force required
to rotate the eyelet member portion 111 relative to the threaded
member 109. Rotational forces for the eyelet member portion may be
between about 1 in/lb (0.11 N/m) and about 20 in/lb (2.26 N/m).
Alternatively, the eyelet member portion 111 may configured to be
in a fixed, non-rotatable position, relative to the threaded member
109 and not rotate about the longitudinal axis 101 of the eyelet
interference screw.
[0052] In one embodiment, the eyelet interference screw 100 has an
outer diameter D1, as shown in FIG. 1. In one embodiment, the
diameter D1 and length L1 may be varied based upon the surgical
procedure, implant to be affixed and/or tissue being repaired. As a
non-limiting example only, D1 may be within the range of about 2.5
mm to about 10.5 mm and length L1 may be within range of about 8 mm
to about 35 mm. The eyelet member 120 includes a length L3 and the
threaded member includes a length L2. When eyelet member 120 is
coupled to threaded member 109 the overall length of the eyelet
interference screw 100 is length L1, as depicted in FIG. 3.
[0053] In one embodiment, as shown in FIGS. 4A-6, the eyelet member
portion 111 has a first end 122 and a second end 124, as shown in
the respective end views depicted in FIGS. 4A-6. The second end 124
includes a connector projection 160 and the first end 122 includes
the eyelet member 120 and the eyelet opening 150. Eyelet opening
150 is configured to allow for joining sutures and/or an implant
passing through the eyelet opening 150 and secured to the eyelet
member 120. The eyelet opening 150 is configured to have a length
L4 and width W4, which are each are optionally dimensioned to allow
for sutures and/or an implant to be secured to the eyelet opening
150 and the eyelet member 120. In one embodiment, the length LA and
width W4 of the eyelet opening 150 is optimized for a particular
surgical procedure, implant, or tissue location, where the length
L4 and/or width W4 may be greater or lesser due to the nature of
the surgical location, ligament, tissue and the like. In one
embodiment, the diameters D4 are between about 3.0 mm to about 7.0
mm and the length L4 is between 4.0 mm and about 10.0 mm.
[0054] The eyelet member 120 has a first end 158 and a second end
154. First end 158 of eyelet member 120 may have a curved or
rounded configuration to facilitate insertion of the eyelet
interference screw 100 into the blind hole 99. The second end 154
of the eyelet member 120 is adjacent to and abuts the connector
projection 160. The eyelet opening 150 may have a variety of
shapes, including, for example, circular, oval, elliptical,
polygonal, hexagonal, a locking V-notch, or the like. An eyelet
opening 150 having a generally oval shape is depicted in FIG. 4A,
whereas, an eyelet opening 150 having a V-notch 156 is depicted in
FIG. 4B.
[0055] The second end 154 has a width W7 that is greater than a
width W4 of the first end 158 of the eyelet member 120, as depicted
in FIG. 6. The difference between W4 and W7 provides space for a
suture or implant to extend outward from blind hole 99 once the
eyelet interference screw 100 is fully placed in the blind hole
99.
[0056] As shown in FIGS. 4A-4B, the connector projection 160
includes a first section 162 that joins the connector projection
160 to the eyelet member 120 and a section 164 that extends from
the first portion 162. The second section 164 includes at least one
of a plurality of legs 165, 166, and may include a first leg 165
and a second leg 166 that flex or transpose inward towards a slot
gap when operably disposed with the central core member 140. The
connector projection 160 is generally coaxial and concentric with
the threaded member 109 to allow for rotation within the central
bore central about the longitudinal axis. In another embodiment,
the snap fit extension includes a plurality of legs, such that
there is a first leg, a second leg, and a third leg that flex
inwards or transpose inward towards a gap when operably disposed
with the central core member 140. In another embodiment, the snap
fit extension includes a plurality of legs, such that there is a
first leg, a second leg, a third leg, and a fourth leg that flex
inwards or transpose inward towards a gap when operably disposed
with the central core member 140.
[0057] As shown in FIG. 4B, the connector projection 160 has a
length L8 configured to pass through the at least a portion of the
central bore 190 of threaded member 109. The first leg 165 includes
a first pawl 167 and the second leg 166 includes a second pawl 168
to seat within the threaded member and prevent distal movement of
the eyelet member 120 during operation. The first pawl 167 and the
second pawl 168 define a diameter D6, as shown in FIG. 5. In
alternative embodiments, the second section 164 may include other
extensions and connections, such as a threaded, sealed, or
bracketed connection. The first section 162 includes a curvilinear
section 169 to permit the eyelet member 120 to swivel about the
longitudinal axis of the eyelet interference screw.
[0058] As shown in FIGS. 7-8, the central core member 140 has an
unthreaded section 142 and an externally threaded section 144. The
central bore 190 of the externally threaded section 144 terminates
in a driver coupling opening 180 and, as illustrated in FIG. 8, the
central bore 190 within the unthreaded section 142 terminates in a
receiving opening 196. Driver coupling opening 180 is configured to
receive a driver for applying torsional or linear forces to the
threaded member 109. In one embodiment, the central bore 190
includes a plurality of splines 181 on an inner surface of central
bore 190 in the externally threaded section 144. The plurality of
splines operably engage with the driver.
[0059] The threaded member 109 of the eyelet interference screw
includes at least one external helical thread 148 on the outer
surface of the central core member 140. The at least one external
helical thread 148 may be a single continuous helical thread or may
be plural discontinuous threads. A thread pitch, or the distance
between adjacent helical rings of the at least one external helical
thread 148, may be uniform or may be non-uniform. The at least one
external helical thread 148 may extend along a substantial
longitudinal extent of the threaded member 109, as depicted in
FIGS. 1-3, or may extend along only a portion of the longitudinal
extend of the threaded member 109, as depicted in FIGS. 7-8. In the
later instance, an unthreaded section 142 of the central core
member 140 of threaded member 109 will be present. In either
instance, the length L5 of the at least one external helical thread
148 is preferably at least two times the helical pitch of the
threaded member 109.
[0060] As shown in FIGS. 7-8, the first end section 191 of central
bore 190 may, optionally, have an inward taper 192 to receiving
opening 196. Inward taper 192 tapers toward central bore 190 and
has a relatively larger diameter at its outermost aspect than ID1
of the first end section 191 central bore 190. When employed, the
inward taper 192 facilitates engaging the connector projection 160
of the eyelet member 120 with central bore 190.
[0061] In accordance with the embodiment depicted in FIGS. 7-10,
the unthreaded section 142 of threaded member 109 has a length L6.
Length L6 may be between about 0.10 mm and about 45.0 mm and is
selected based upon the implant to be employed in a surgical
procedure. It will be understood that the longer the length L6, the
larger the unthreaded surface area will be provided for the eyelet
interference screw 100.
[0062] As shown in FIGS. 7-10, and as discussed above with
reference to FIGS. 1-3, central bore 190 has the first end section
191 that opens to the receiving opening 196 and the second end
section 193 that opens to the driver coupling opening 180. Driver
coupling opening 180 is configured to accept and couple to a
driver, as will be discussed hereinafter with reference to FIGS.
13A-16, which is employed in the method of the present invention to
place and seat the eyelet interference screw 100 in the blind hole
99. As previously discussed, the receiving opening 196, receives
the connector projection 160 of the eyelet member 120 therethrough
to operably couple the eyelet member 120 to the threaded member
109. The receiving opening 196 may be tapered inward to mate with a
corresponding taper of the first section 162 of the connector
projection 160 with the eyelet member 120 and the threaded member
109 are coupled to each other.
[0063] FIG. 11 depicts a magnified view of connector projection 160
fully engaged within first end section 191 of central bore 190.
Tapered receiving opening 196 mates with the taper of first portion
162, and connector projection 160 extends through first end section
191 of central bore 190 such that the legs 117 of connector
projection 160 pass into the second end section 193 of the central
bore 190 and at least one pawl 115 seat against flange 113 to
secure the eyelet member 120 to the threaded member 109.
[0064] FIG. 12 depicts an alternative eyelet interference screw
300. Eyelet interference screw 300 is like eyelet interference
screw 100, except that the external helical thread 148 on the
threaded section 144 of the eyelet interference screw 100 is
replaced with at least one circumferential ring 302 or plural
adjacent circumferential rings 302 that project radially outward
from the surface of the central core member 140. Circumferential
rings 302 may have a wide variety of configurations, for example,
circumferential rings 302 may canted toward the driver opening 180
to facilitate insertion of the eyelet interference screw 300 into
the blind hole 99 and also provide resistance to withdrawal of the
eyelet interference screw 300 from the blind hole 99 once fully
inserted. Circumferential rings 302 may also be radially extending
substantially perpendicular to the longitudinal axis of the eyelet
interference screw. The extent to which circumferential rings
project from the central core member 140 may be determined by a
number of non-exclusive factors, including, for example, the
pliability or compliance desired for the circumferential rings, the
match with the diameter of the blind hole 99, the degree of
resistance force desired to insert or withdraw the eyelet
interference screw 300 into or from the blind hole 99,
respectively, or the anchoring force desired for the eyelet
interference screw 300.
[0065] It will also be appreciated that the threaded section 144 of
eyelet interference screw 100, 300 may external helical threads
148, circumferential rings 302, or combinations of external helical
threads 148 and circumferential rings 302 along different
longitudinal regions of the threaded section 144.
[0066] In one embodiment, the eyelet interference screw eliminates
transosseous tunnels in tendon repairs and ligament reconstructions
by simplifying tissue fixation in a bone socket while maintaining
tension of the tissue throughout fixation.
[0067] The eyelet interference screw comprises an increased initial
fixation strength, thereby decreasing the risk of early failure
during rehabilitation for any implant or interference screw.
[0068] Alternative sizes and configurations of the inventive eyelet
interference screw are contemplated by the present invention and
may be employed depending upon the tissue, tendon, or ligament to
be repaired. Implants which may be employed with the eyelet
interference screw 100 may have a wide variety of dimensions,
including, for example about 3 cm.times.about 4 cm, about 4
cm.times.about 6 cm, and about 6 cm.times.about 9 cm, about 0.3
cm.times.about 8.0 cm, about 0.3 cm.times.about 16 cm, about
0.3.times.32 cm, about 0.5 cm.times.about 8.0 cm, about 0.5
cm.times.about 16 cm, about 0.7 cm.times.about 8 cm, about 0.7
cm.times.about 16 cm, about 0.7 cm.times.about 32 cm, about 0.5
cm.times.about 32 cm. The implants may have a generally
cylindrical, generally tubular, or generally planar configuration.
The implant itself may have thickness between about 0.5 mm and
about 1.5 mm. The implant may have a modulus of elasticity between
about 12 Mpa and about 16 Mpa, alternatively between about 12 Mpa
and about 116 Mpa. The modulus of elasticity may be selected
according to the tissue, tendon, or ligament being treated.
[0069] Instruments useful in the method of the present invention to
fix the eyelet interference screw 100 to tissue are shown in FIGS.
14-16. A drill bit 210 and tap 220 are employed create and prepare
the hole 99 in the bone. The eyelet interference screw 100 is
either loaded or preloaded on the driver 230. The implant 240 and
sutures 232 are joined to the eyelet member 120, either before or
after loading the eyelet interference screw 100 onto the driver
230. The driver 230 couples to the eyelet interference screw 100 at
the driver coupling opening 180 of the threaded member 109. As
shown in FIGS. 13A-13D, the eyelet member 120, having the implant
240 and sutures 232 joined thereto, is introduced into the blind
hole 99 and the eyelet interference screw is then inserted into the
blind hole 99 using the driver 230 until the at least one external
thread 148 on the central core member 140 engage with the bone
tissue surrounding the blind hole 99. The driver 230 is then
rotated to screw the threaded member 109 into the bone hole and
drive the eyelet member 120 further into the blind hole 99, with
the implant 240 and sutures 232 extending along the length L1 of
the eyelet interference screw 100 and projecting out of the blind
hole 99.
[0070] It will be understood by those skilled in the art, that a
wide variety of drill bits, including different diameters, lengths,
and configurations may be employed, as is well known in the
orthopedic field, to create different dimensions for blind hole
99.
[0071] In one embodiment, the drill bit 210 employed for drilling
into the bone tissue to create the blind hole 99. Optionally, a
guidewire may be used for guiding the drill during drilling the
blind hole 99. The tap 220 allows for precise tapping near the
bone. As shown in FIG. 15, a drill guide 200 having a drill collar
202 may be used to delimit the depth of drilling and define a depth
of the blind hole 99. A wide variety of drill guides 200 are well
known in the art, and, in addition to a stop collar-type drill
guide, there are also drill stop collars that removably attach to
drill bits to delimit the depth of drilling to form the blind hole
99 in the bone tissue.
[0072] A driver or other tensioning device is used to tamp and/or
thread the implant into the bone, according to one embodiment. The
driver may be any configuration suitable for applying a rotary
force to the eyelet interference screw, including, without
limitation, slotted, cruciform, internal polygon, hexalobular,
three-pointed or other. Slotted drivers include a slot drive and a
cross drive type. Cruciform drive types include, for example
Phillips, Frearson, French recess, mortorq, torq-set, or the like.
Internal polygon driver types include, for example, tri-angle,
double square, Robertson, triple-square, hex socket or Allen,
12-spline flange, security hex or double hex. Hexalobular driver
types include, for example, torx, line head, or polydrive.
Three-pointed driver types include, for example, tri-point,
tri-wing or tri-groove.
[0073] With the eyelet of the eyelet interference screw 100
coaxially aligned with the blind hole 99, a mallet or other
suitable tamping driver may be used to insert and seat the eyelet
of the eyelet interference screw 100 into the blind hole 99 until
seated at the threaded interface 106, as shown in FIG. 13C. Once
seated at the threaded interface 106, the driver handle 250 may
either be rotated to thread the eyelet interference screw 100 into
the bone 110 or continued to be malleted to drive the eyelet
interference screw 100 into the bone 110. The sutures 232 and the
implant 240 coupled to the eyelet member 120 are pushed into the
blind hole 99 as the eyelet interference screw 100 is tamped and/or
screwed into the blind hole 99. A second end of the sutures 232 and
the implant 240, which is to be affixed to a secondary eyelet
interference screws 100, remain either within or external to the
driver. The screwdriver 130 is used to drive the threaded member
109 of the eyelet interference screw 100 until it is flush with the
surface of the bone, as shown in FIG. 13C. The final step is to
remove driver 230 leaving behind the eyelet interference screw 100
and implant 240 with sutures 232, as shown in FIG. 13D. To complete
the procedure, create and prepare a second blind hole 99 as
described above. Thread the free end of the implant 240 through the
eyelet of a second eyelet interference screw. The tamp and thread
method is also employed as described above to seat and deliver a
second eyelet interference screw and tension the implant as
appropriate.
[0074] The eyelet interference screw 100, 300, together with an
implant 240 sutured to the eyelet member with sutures 232, may be
pre-loaded onto the driver 230. As illustrated in FIGS. 13A-13D,
the driver 230 may include an interior chamber 234 that houses the
implant 240 and sutures 232. In this manner, when eyelet
interference screw 100, 300 is decoupled from the driver 230, the
implant 240 and sutures 232 are released from the interior chamber
234 and are available for attachment to a second eyelet
interference screw 100, 300 for attachment to a second bone tissue
110.
[0075] It should be appreciated that all the described embodiments
may be custom sized, molded and/or fitted for any clinician based
on implant size or anatomy. All the described embodiments may be
configured for tissue, tendon, or ligament to be repaired.
Moreover, all the described instruments may be formed from any
conformable, flexible, rigid, or semi-rigid biocompatible material,
e.g., metal, metal alloy, polymer, or the like. The eyelet
interference screw 100 may be made at, least partially, from an
osteoconductive, osteoinductive, and/or biodegradable material,
provided that the material should be strong enough not to break
during screw insertion and should provide adequate fixation
strength during the healing period. Biodegradable materials may
include polymers and copolymers. Examples of suitable materials for
making the eyelet interference screw 100, including the eyelet
member 120 and the threaded member 109, include, without
limitation, polyether ether ketone (PEEK), stainless steel,
titanium, cobalt-chromium alloys, shape memory metals, such as
nickel titanium alloys, titanium-palladium-nickel alloys,
nickel-zirconium-titanium alloys, titanium-niobium alloy,
titanium-nickel-niobium alloy, or like biocompatible materials
having sufficient hardness, fatigue resistance, corrosion
resistance operable to allow for delivery, affixation and anchoring
of the repair implant. Any of the embodiments described herein may
be used separately from and/or in combination with each other,
where practical.
[0076] All publications and patent applications mentioned in this
specification are herein incorporated by reference to the same
extent as if each individual publication or patent application was
specifically and individually indicated to be incorporated by
reference.
[0077] While the invention has been described in connection with
various embodiments, it will be understood that the invention is
capable of further modifications. This application is intended to
cover any variations, uses or adaptations of the invention
following, in general, the principles of the invention, and
including such departures from the present disclosure as, within
the known and customary practice within the art to which the
invention pertains.
* * * * *