U.S. patent application number 17/140652 was filed with the patent office on 2021-04-29 for knotless suture anchor.
The applicant listed for this patent is DePuy Mitek, LLC. Invention is credited to Joseph Hernandez.
Application Number | 20210121170 17/140652 |
Document ID | / |
Family ID | 1000005316454 |
Filed Date | 2021-04-29 |
![](/patent/app/20210121170/US20210121170A1-20210429\US20210121170A1-2021042)
United States Patent
Application |
20210121170 |
Kind Code |
A1 |
Hernandez; Joseph |
April 29, 2021 |
KNOTLESS SUTURE ANCHOR
Abstract
Methods and devices are provided for anchoring suture to bone.
In one exemplary embodiment, a suture anchor is provided that
includes a proximal component, a distal component, and an
intermediate component positioned between the distal component and
the proximal component. The proximal and distal components can each
be configured to move independent of one another and to move
relative to the intermediate component. In this way, the proximal,
intermediate, and distal components of the suture anchor can be
configured to cooperate with one another to prevent removal of the
suture anchor from a bone hole in which the suture anchor is
disposed and to lock a suture relative to the suture anchor and to
the bone hole.
Inventors: |
Hernandez; Joseph;
(Sandwich, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
DePuy Mitek, LLC |
Raynham |
MA |
US |
|
|
Family ID: |
1000005316454 |
Appl. No.: |
17/140652 |
Filed: |
January 4, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14847492 |
Sep 8, 2015 |
10881389 |
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17140652 |
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13329836 |
Dec 19, 2011 |
9138220 |
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14847492 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/0451 20130101;
A61B 2017/0441 20130101; A61B 2017/0446 20130101; A61B 2017/0409
20130101; A61B 2017/0445 20130101; A61B 2017/0448 20130101; A61B
2017/045 20130101; A61B 2017/0424 20130101; A61B 17/0401
20130101 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1-5. (canceled)
6. A surgical system, comprising: a surgical instrument including a
proximal portion and a distal portion, the distal portion including
a first thread; an anchor configured to be implanted in bone, the
anchor including an internal thread and an external thread;
wherein: the anchor is configured to move from a first
configuration to a second configuration and from the second
configuration to a third configuration; in the first configuration
the internal thread of the anchor is threadably engaged with the
first thread of the surgical instrument, and the external thread of
the anchor is not threadably engaged with the bone; in the second
configuration the internal thread of the anchor is threadably
engaged with the first thread of the surgical instrument, and the
external thread of the anchor is threadably engaged with the bone;
in the third configuration the internal thread of the anchor is not
threadably engaged with the first thread of the surgical
instrument, and the external thread of the anchor is threadably
engaged with the bone; the proximal portion of the surgical
instrument is configured to move relative to the distal portion of
the surgical instrument and thereby cause the anchor to move from
the first configuration to the second configuration; and the
proximal and distal portions of the surgical instrument are
configured to move relative to the proximal portion of the surgical
instrument and thereby cause the anchor to move from the second
configuration to the third configuration.
7. The system of claim 6, wherein the movement of the proximal and
distal portions of the surgical instrument is configured to
unthread the internal thread and the first thread of the surgical
instrument.
8. The system of claim 6, wherein the anchor has a hole formed
through a sidewall thereof; the hole is configured to receive a
suture therethrough; and the movement of the anchor from the first
configuration to the second configuration is configured to cause
the suture to be fixed between the bone and the external thread of
the anchor.
9. The system of claim 6, wherein the anchor includes a proximal
portion that includes the external thread, and the anchor includes
a distal portion that includes the internal thread.
10. The system of claim 9, wherein the movement of the anchor from
the second configuration to the third configuration is configured
to cause the distal portion of the anchor to move proximally
relative to the proximal portion of the anchor.
11. The system of claim 9, wherein the anchor includes an
intermediate portion; in the first and second configurations the
distal portion of the anchor seats a first portion of the
intermediate portion of the anchor therein; and in the third
configuration the distal portion of the anchor seats a second,
larger portion of the intermediate portion of the anchor
therein.
12. The system of claim 11, wherein in the first, second, and third
configurations the intermediate portion of the anchor seats the
proximal portion of the anchor therein.
13. The system of claim 9, wherein the anchor includes an
intermediate portion with a hole formed through a sidewall thereof;
the hole is configured to receive a suture therethrough; and the
movement of the anchor from the second configuration to the third
configuration is configured to fix the suture between the distal
portion of the anchor and the intermediate portion of the
anchor.
14. The system of claim 13, wherein the movement of the anchor from
the first configuration to the second configuration is configured
to cause the suture to be fixed between the bone and the external
thread of the anchor.
15. The system of claim 9, wherein the movement of the anchor from
the second configuration to the third configuration is configured
to cause the distal portion of the anchor to increase in width.
16. A surgical method, comprising: threading an external thread of
an anchor into bone using a surgical instrument that is threadably
engaged with an internal thread of the anchor; and after threading
the external thread of the anchor into the bone, moving the
surgical instrument, which is threadably engaged with the internal
thread of the anchor, proximally relative to a proximal portion of
the anchor, thereby simultaneously causing a distal portion of the
anchor to increase in width, and the distal portion of the anchor
to move proximally relative to the proximal portion of the
anchor.
17. The method of claim 16, wherein moving a proximal portion of
the surgical instrument relative to a distal portion of the
surgical instrument causes the threading of the external thread of
the anchor into the bone; and moving the proximal and distal
portions of the surgical instrument relative to the proximal
portion of the surgical instrument causes the distal portion of the
anchor to move proximally relative to the proximal portion of the
anchor.
18. The method of claim 16, wherein moving the surgical instrument
proximally includes axial translation of the surgical instrument
relative to the proximal portion of the anchor; and the method
further comprises, after the distal portion of the anchor has
increased in width and after the distal portion of the anchor has
moved proximally relative to the proximal portion of the anchor,
rotating the surgical instrument relative to the proximal and
distal portions of the anchor, thereby causing the surgical
instrument to unthread from the internal thread of the anchor.
19. The method of claim 16, wherein the anchor includes an
intermediate portion in which the proximal portion of the anchor is
seated during the threading of the external thread of the anchor
into the bone and during the proximal movement of the distal
portion of the anchor relative to the proximal portion of the
anchor; and the proximal movement of the distal portion of the
anchor is also relative to the intermediate portion of the
anchor.
20. The method of claim 16, the threading of the external thread of
the anchor into the bone causes a suture extending through a hole
formed in a sidewall of the anchor to be fixed between the bone and
the external thread of the anchor.
21. The method of claim 20, wherein the hole is formed in an
intermediate portion of the anchor; and the proximal movement of
the distal portion of the anchor causes the suture to be fixed
between the distal portion of the anchor and the intermediate
portion of the anchor.
22. The method of claim 21, wherein the proximal movement of the
distal portion of the anchor is also relative to the intermediate
portion of the anchor.
23. A surgical method, comprising: with a cannulated proximal
portion of an anchor seated in a cannulated intermediate portion of
the anchor and with a suture extending through a hole in the
anchor, rotating the proximal portion of the anchor relative to a
cannulated distal portion of the anchor, thereby threading the
proximal portion of the anchor into bone and causing a first length
of the suture to become fixed between the bone and the proximal
portion of the anchor; and after threading the proximal portion
into the bone, moving the distal portion of the anchor proximally
relative to the proximal and intermediate portions of the anchor,
thereby causing the distal portion of the anchor to increase in
width and causing a second length of the suture to become fixed
between the distal portion of the anchor and the intermediate
portion of the anchor.
24. The method of claim 23, wherein rotating a proximal portion of
a surgical instrument relative to a distal portion of the surgical
instrument causes the rotation of the proximal portion of the
anchor relative to the distal portion of the anchor; and
translating the proximal and distal portions of the surgical
instrument proximally relative to the proximal and intermediate
portions of the anchor causes the movement of the distal portion of
the anchor proximally relative to the proximal and intermediate
portions of the anchor.
25. The method of claim 24, wherein the surgical instrument is
threadably engaged with the distal portion of the anchor during the
rotation of the proximal portion of the surgical instrument
relative to the distal portion of the surgical instrument; and the
method further comprises, after the movement of the distal portion
of the anchor proximally relative to the proximal and intermediate
portions of the anchor, rotating the surgical instrument relative
to the distal portion of the anchor such that the surgical
instrument unthreads from the distal portion of the surgical
instrument.
26. The method of claim 23, wherein moving the distal portion of
the anchor proximally relative to the proximal and intermediate
portions of the anchor also causes the distal portion of the anchor
to decrease in height.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S.
application Ser. No. 14/874,492, filed on Sep. 8, 2015, entitled
"Knotless Suture Anchor," which is a continuation of U.S.
application Ser. No. 13/329,836, filed on Dec. 19, 2011, now U.S.
Pat. No. 9,138,220, entitled "Knotless Suture Anchor," which are
hereby incorporated by reference in their entireties.
FIELD OF THE INVENTION
[0002] The present invention relates generally to methods and
devices for anchoring soft tissue to bone, and in particular to
knotless suture anchors and methods for use.
BACKGROUND OF THE INVENTION
[0003] The complete or partial detachment of ligaments, tendons,
and/or other soft tissues from their associated bones within the
body are relatively commonplace injuries, particularly among
athletes. Such injuries are generally the result of excessive
stresses being placed on these tissues. By way of example, tissue
detachment may occur as the result of an accident such as a fall,
over-exertion during a work-related activity, during the course of
an athletic event, or in any one of many other situations and/or
activities.
[0004] In the case of a partial detachment, the injury will
frequently heal itself, if given sufficient time and if care is
taken not to expose the injury to further undue stress. In the case
of complete detachment, however, surgery may be needed to re-attach
the soft tissue to its associated bone or bones. Numerous devices
are currently available to re-attach soft tissue to bone. Examples
of such currently-available devices include screws, staples, suture
anchors and tacks. In soft tissue re-attachment procedures
utilizing screws, the detached soft tissue is typically moved back
into its original position over the bone. Then the screw is screwed
through the soft tissue and into the bone, with the shank and head
of the screw holding the soft tissue to the bone. Similarly, in
soft tissue re-attachment procedures utilizing staples, the
detached soft tissue is typically moved back into its original
position over the bone. Then the staple is driven through the soft
tissue and into the bone, with the legs and bridge of the staple
holding the soft tissue to the bone.
[0005] In soft tissue re-attachment procedures utilizing suture
anchors, an anchor-receiving hole is generally first drilled in the
bone at the desired point of tissue re-attachment. Then a suture
anchor is deployed in the hole using an appropriate installation
tool. This effectively locks the suture to the bone, with the free
end(s) of the suture extending out of the bone. The free ends of
the suture are passed through or around the soft tissue and are
used to tie the soft tissue securely to the bone.
[0006] While current suture anchors are effective in anchoring soft
tissue to bone, one drawback with current devices is that anchors
can shift within bone following implantation due to a problem such
as poor bone quality of a particular patient. The anchor and/or any
soft tissue attached to the anchor via suture can therefore shift
in position relative to the bone, which can delay or prevent proper
healing.
[0007] Accordingly, there remains a need for improved methods and
devices for attaching soft tissue to bone.
SUMMARY OF THE INVENTION
[0008] In one embodiment, a suture anchor is provided that includes
a cannulated elongate member including a distal component, a
proximal component, and an intermediate component positioned
between the distal component and the proximal component. The
cannulated elongate member can be configured to be secured within a
bone hole by a threaded engagement between the proximal component
and the bone hole, and by radial expansion of the distal component
within the bone hole. The cannulated elongate member can be
configured to secure a suture thereto by engaging the suture
between the bone hole and threads formed on an external surface of
the proximal component, and by engaging the suture between the
distal component and the intermediate component. The proximal,
intermediate, and distal components can be axially aligned.
[0009] The proximal, intermediate, and distal components can each
have a variety of configurations. The proximal component can be
configured to rotate about a longitudinal axis thereof relative to
the intermediate and distal components. The distal component can be
configured to radially expand and engage the suture between the
distal component and the intermediate component when the
intermediate component is inserted into a bore formed in the distal
component. The intermediate component can have a hole formed
through a sidewall thereof proximal to a distal end of the
intermediate component and proximal to a proximal end of the distal
component. The hole can be configured to have the suture extend
therethrough at least when the suture is engaged between the distal
component and the intermediate component. The intermediate and
distal components can have unthreaded external surfaces.
[0010] In another embodiment, a suture anchor is provided that
includes a cannulated elongate member including a distal component,
a proximal component, and an intermediate component positioned
between the distal component and the proximal component. When the
cannulated elongate member is disposed within a bone hole and a
suture is coupled to the cannulated elongate member, the cannulated
elongate member can be configured to have a first configuration and
a second configuration. In the first configuration, the proximal
component can be threadably engaged with the bone hole to prevent
removal of the cannulated elongate member from the bone hole, and
the suture can be engaged between the bone hole and threads on an
external surface of the proximal component. The suture can be
freely slidable through the intermediate component. In the second
configuration, the distal component can be advanced proximally over
the intermediate component such that the distal component radially
expands, as compared to the distal component in the first
configuration, to engage the bone hole. The suture can be engaged
between the distal component and the intermediate component.
[0011] When the cannulated elongate member is in the first
configuration, a first length of the intermediate component can be
disposed within the distal component, and when the cannulated
elongate member is in the second configuration, a second length of
the intermediate component can be disposed within the distal
component. The second length can be greater than the first length.
When the cannulated elongate member is in the second configuration,
the proximal component can be threadably engaged with the bone hole
to prevent removal of the cannulated elongate member from the bone
hole, and/or the suture can not be freely slidable through the
intermediate component.
[0012] In another aspect, a suture anchoring system is provided
that includes an elongate shaft having a proximal handle portion
and a distal portion configured to be inserted through tissue, a
proximal component freely slidably disposed on the distal portion
of the elongate shaft and having threads formed on an external
surface thereof, an intermediate component freely slidably disposed
on the distal portion of the elongate shaft at a location distal to
the proximal component, and a distal component threadably engaged
with threads formed on the distal portion of the elongate shaft.
The distal component can be positioned distal to the intermediate
component, and the distal component can be configured to expand
when the distal component is advanced over the intermediate
component.
[0013] The proximal, intermediate, and distal components can each
have a variety of configurations. The distal and intermediate
components can be configured to engage a suture therebetween when
the distal component is advanced over the intermediate
component.
[0014] The elongate shaft can also have a variety of
configurations. The elongate shaft can extend through axially
aligned inner lumens formed through the proximal, intermediate, and
distal components. The elongate shaft can be configured to move
proximally relative to the proximal and intermediate components to
advance the distal component proximally relative to the proximal
and intermediate components such that the distal component expands
around the intermediate component. The elongate shaft can be
configured to be threadably disengaged from the distal component
after the distal component has radially expanded around the
intermediate component to allow the elongate shaft to be slidably
released from the proximal, intermediate, and distal
components.
[0015] In yet another aspect, a method for anchoring tissue to bone
is provided that includes advancing a suture anchor disposed on a
distal end of an insertion shaft into bone distally such that the
suture anchor is at least partially disposed within the bone,
threads on a proximal portion of the suture anchor are engaged with
the bone, and a suture coupled to soft tissue is engaged between an
outer surface of the suture anchor and the bone. After advancing
the suture anchor into the bone, the suture anchor can be actuated
to cause a sleeve of the suture anchor to expand to engage the bone
and prevent removal of the suture anchor from the bone, and to
cause the suture to be engaged by compression fit between the
sleeve and a pin member of the suture anchor. Advancing the suture
anchor can include rotating the insertion shaft and the proximal
portion of the suture anchor relative to the pin member and the
sleeve. In some embodiments, the insertion shaft can include a
bone-penetrating distal tip, and advancing the suture anchor can
include forming a hole in the bone. In some embodiments, advancing
the suture anchor can include positioning the suture anchor into a
pre-formed hole in the bone.
[0016] Actuating the suture anchor can include advancing the
insertion shaft proximally such that the sleeve moves proximally
relative to the pin member and the proximal portion of the suture
anchor. Advancing the insertion shaft proximally can include
pulling the insertion shaft in a proximal direction.
[0017] When the suture anchor is advanced into the bone and when
the suture anchor is actuated, the insertion shaft can extend
through axially aligned inner lumens formed through the proximal
portion, the sleeve, and the pin member. The sleeve can be located
distal to the proximal portion, and the pin member can be located
between the sleeve and the proximal portion.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] The invention will be more fully understood from the
following detailed description taken in conjunction with the
accompanying drawings, in which:
[0019] FIG. 1 is a side view of one embodiment of a suture anchor
in an undeployed configuration;
[0020] FIG. 2 is a side view of the suture anchor of FIG. 1 in a
deployed configuration;
[0021] FIG. 3 is an exploded, partially transparent view of the
suture anchor of FIG. 1;
[0022] FIG. 4 is side, cross-sectional view of another embodiment
of a suture anchor in an undeployed configuration;
[0023] FIG. 5 is a side, cross-sectional view of the suture anchor
of FIG. 4 in a deployed configuration;
[0024] FIG. 6 is a side, partially transparent view of yet another
embodiment of a suture anchor in an undeployed configuration;
[0025] FIG. 7 is side view of the suture anchor of FIG. 6 in a
deployed configuration;
[0026] FIG. 8 is a side, cross-sectional view of the suture anchor
of FIG. 1 partially disposed in the undeployed configuration in a
bone hole;
[0027] FIG. 9 is a side, cross-sectional view of the suture anchor
of FIG. 8 further disposed in the undeployed configuration in the
bone hole;
[0028] FIG. 10 is a side, cross-sectional view of the suture anchor
of FIG. 9 disposed in the deployed configuration in the bone
hole;
[0029] FIG. 11 is side, partial view of a distal portion of a
suture anchor driver;
[0030] FIG. 12 is a side, cross-sectional view of the suture anchor
of FIG. 4 partially disposed in the undeployed configuration in a
bone hole;
[0031] FIG. 13 is a side, cross-sectional view of the suture anchor
of FIG. 11 having a suture anchor driver inserted therethrough;
[0032] FIG. 14 is a side, cross-sectional view of the suture anchor
of FIG. 12 further disposed in the undeployed configuration in the
bone hole;
[0033] FIG. 15 is a side, cross-sectional view of the suture anchor
of FIG. 14 having the suture anchor driver of FIG. 13 inserted
therethrough; and
[0034] FIG. 16 is a side, cross-sectional view of the suture anchor
of FIG. 14 disposed in the deployed configuration in the bone
hole.
DETAILED DESCRIPTION OF THE INVENTION
[0035] Certain exemplary embodiments will now be described to
provide an overall understanding of the principles of the
structure, function, manufacture, and use of the devices and
methods disclosed herein. One or more examples of these embodiments
are illustrated in the accompanying drawings. Those of ordinary
skill in the art will understand that the devices and methods
specifically described herein and illustrated in the accompanying
drawings are non-limiting exemplary embodiments and that the scope
of the present invention is defined solely by the claims. The
features illustrated or described in connection with one exemplary
embodiment may be combined with the features of other embodiments.
Such modifications and variations are intended to be included
within the scope of the present invention.
[0036] Various exemplary methods and devices are provided for
anchoring soft tissue to bone. In general, the methods and devices
can allow soft tissue to be secured to bone using a suture coupled
to a suture anchor without the need to knot or otherwise tie the
suture to secure the soft tissue in place relative to the bone.
Exemplary suture anchor drivers are also provided that can be used
with the various methods and devices disclosed herein, or with
other methods and devices known in the art. A person skilled in the
art will appreciate that while methods and devices are disclosed
herein for anchoring soft tissue to bone, the methods and devices
can be used in a variety of other medical procedures for anchoring
various objects to one another.
[0037] In an exemplary embodiment, a cannulated suture anchor is
provided that includes a proximal component, a distal component,
and an intermediate component positioned between the distal
component and the proximal component. The proximal and distal
components can each be configured to move independent of one
another and to move relative to the intermediate component. In this
way, the proximal, intermediate, and distal components of the
suture anchor can be configured to cooperate with one another to
prevent removal of the suture anchor from a bone hole in which the
suture anchor is disposed and to lock a suture relative to the
suture anchor and to the bone hole. The suture can be coupled to
the suture anchor and can be configured to be engaged between the
bone hole and threads formed on an external surface of the proximal
component, as well as engaged between the distal component and the
intermediate component. The suture can be attached to a soft
tissue, thereby allowing the suture anchor to lock the soft tissue
in a fixed position relative to the bone hole to facilitate
healing. The suture anchor can therefore be configured to lock the
suture and soft tissue relative to the bone hole using two types of
fixation, namely by compressing the suture between the bone hole
and the external threads of the proximal portion and by compressing
the suture between the intermediate and distal components. By being
configured to lock the suture and soft tissue relative to the bone
hole using two types of fixation, the suture anchor can reduce
chances of the suture and/or the soft tissue from slipping or
migrating after the suture anchor has been implanted into bone,
thereby facilitating healing. Additionally, the suture anchor can
be configured to engage the bone hole in two independent ways to
prevent removal of the suture anchor therefrom. First, the threads
on the proximal portion of the suture anchor can engage the bone
hole. Second, the distal component can be configured to radially
expand when the intermediate component is inserted into a bore
formed in the distal portion, thereby pressing the distal component
against the bone hole to secure the anchor therein by compression
fit. The suture anchor can therefore help prevent slipping or
migration of the suture anchor within the bone hole once implanted
therein, thereby facilitating healing.
[0038] The suture anchor can be formed from a variety of materials.
In an exemplary embodiment, the material can have physical
properties that are sufficient to allow a driver to be inserted
into a cannulated interior of the anchor and to be used to drive
the anchor into bone without damaging the anchor. The properties of
the material will depend on the particular configuration of the
anchor. Non-limiting examples of materials that can form the suture
anchor include metals such as titanium, polymers such as polyether
ether ketone (PEEK), and combinations thereof. In an exemplary
embodiment, the anchor can be absorbable, but the anchor can
instead be non-absorbable, or combinations thereof.
[0039] FIGS. 1-3 illustrate one exemplary embodiment of a suture
anchor 10 configured to anchor soft tissue to bone. As in the
illustrated embodiment, the anchor 10 can be configured as an
elongate member including three components. The components can be
axially aligned and can include a proximal component 12, a sleeve
or distal component 14, and a pin member or intermediate component
16 positioned between the proximal component 12 and the distal
component 14. Each of the proximal, distal, and intermediate
components 12, 14, 16 can have inner lumens 13, 15, 17 extending
therethrough and in communication with one another such that the
suture anchor 10 is cannulated. The inner lumens 13, 15, 17 are
axially aligned along a longitudinal axis A of the anchor 10 in the
illustrated embodiment, but the inner lumens 13, 15, 17 can be
radially offset from the longitudinal axis A.
[0040] Each of the proximal, distal, and intermediate components
12, 14, 16 can have a variety of sizes, shapes and configurations.
As shown in the illustrated embodiment, the anchor 10 can have a
substantially cylindrical shape with each of the proximal, distal,
and intermediate components 12, 14, 16 having rounded outer
surfaces. In this way, the anchor 10 can correspond to a
substantially cylindrical shape of a bone hole and be easily and
securely disposed therein.
[0041] The proximal component 12 can be cannulated, as mentioned
above, and can have at least one bone-engaging surface feature
formed thereon that is configured to engage bone, e.g., a bone
surface of a bone hole. While various surface features can be used,
such as teeth, ribs, ridges, barbs, protrusions, etc., as in the
illustrated exemplary embodiment, the proximal component 12 can
include a surface feature in the form of at least one thread 18
formed on an external surface thereof and extending around the
proximal component 12. The thread 18 can be a single, continuous
thread as in the illustrated embodiment that extends around the
proximal component 12, or the thread 18 can include a plurality of
threads, as will be appreciated by a person skilled in the art.
[0042] The thread 18 can be located in at least a proximal portion
12p of the proximal component 12. As in the illustrated embodiment,
the thread 18 can extend from a proximal end of the proximal
component 12 and terminate proximal to a distal end of the proximal
component 12, and hence extend along only a proximal portion of the
proximal component 12, e.g., terminate proximal to a distal end
thereof. The proximal portion 12p of the proximal component 12 can
therefore include the thread 18 while a distal portion 12d of the
proximal component 12 can be unthreaded and free of bone-engaging
surface features. Whether the anchor 10 is in a deployed
configuration or an undeployed configuration, discussed further
below, the thread 18 can be located proximal to the distal and
intermediate components 14, 16, which can help maximize an amount
of the thread 18 available to engage bone.
[0043] The proximal component 12 can include a reduced outer
diameter region in which the proximal component 12 has a smaller
outer diameter than a remainder of the proximal component 12. In an
exemplary embodiment, a minor outer diameter D1 of the distal
portion 12d of the proximal component 12 can be less than an outer
diameter D2 of the proximal portion 12p of the proximal component
12. The proximal component 12 can be configured to be inserted into
a proximal end of the intermediate component 16 and it can be at
least partially disposed within the inner lumen 17 of the
intermediate component 16. In an exemplary embodiment, the distal
portion 12d of the proximal component 12 can be configured to be at
least partially inserted into the intermediate component 16, while
the proximal portion 12p of the proximal component 12 can be
prevented from being inserted at all into the intermediate
component. The thread 18 formed on the proximal portion 12p of the
proximal component 12 can therefore be prevented from being
inserted into and possibly damaging the intermediate component 16,
and a maximum amount of the thread 18 can be available to engage
bone.
[0044] At least one of the proximal and intermediate components 12,
16 can include a stop mechanism configured to prevent the proximal
component 12 from being inserted into the intermediate component 16
beyond a certain amount. As in the illustrated embodiment, and as
discussed further below, the intermediate component 16 can include
an internal stop surface 16i configured to abut a distal surface
12s of the proximal component 12. In other words, the internal stop
surface 16i of the intermediate component 16 and the distal surface
12s of the proximal component 12 can be configured to cooperate as
a stop mechanism to prevent over-insertion of the proximal
component 12 into the inner lumen 17 of the intermediate component
16. Alternatively or in addition, a distal surface 12m of the
proximal portion 12p can be configured to abut a proximal surface
16s of the intermediate component 16 to prevent the proximal
component 12 from being inserted into the inner lumen 17 of the
intermediate component 16 beyond a certain amount. In other words,
the distal surface 12m of the proximal portion 12p and the proximal
surface 16s of the intermediate component 16 can be configured to
cooperate as a stop mechanism to prevent over-insertion of the
proximal component 12 into the intermediate component 16. As in the
illustrated embodiment, only a partial longitudinal length of the
distal portion 12d of the proximal component 12 can be configured
to be disposed within the intermediate component 16 such that only
the internal stop surface 16i of the intermediate component 16 and
the distal surface 12s of the proximal component 12 can be
configured to cooperate as a stop mechanism. By being configured to
allow only a partial portion of the reduced diameter region of the
proximal portion 12 to be insertable into the intermediate
component, the anchor 10 can be configured to provide a gap 22
between the proximal and intermediate components 12, 16 when the
proximal component 12 is fully inserted into the intermediate
component 16. The gap 22 can extend around a perimeter or
circumference of the distal portion 12p of the proximal component
12. The gap 22 can help provide space for a suture coupled to the
anchor 10 to be positioned outside the anchor 10, as discussed
further below.
[0045] As mentioned above, the distal component 14 can also have a
variety of sizes, shapes and configurations. As in the illustrated
embodiment, the distal component 14 can taper distally to
facilitate insertion of the distal component 14 within a bone hole
and to facilitate receipt of the intermediate component 16 within
the inner lumen 15 thereof. As in the illustrated embodiment, the
distal component 14 can have a dome or bullet shape with a rounded
end of the distal component 14 at a distal end thereof. A distal
end of a distal component can, however, be configured as a
penetrating tip, e.g., be tapered, pointed, and/or sharpened, which
can facilitate formation of a bone hole and/or facilitate
penetration of the suture anchor into bone. Such a suture anchor
can therefore be configured to be self-awling or self-tapping in
which a bone hole need not be pre-formed prior to inserting the
suture anchor into bone. The distal component 14 can have an
external surface free of bone-engaging surface features. Being free
of external bone-engaging surface features can allow the distal
component 14 to be freely slidable within a bone hole.
[0046] The distal component 14 can be cannulated, as mentioned
above. The inner lumen 15 of the distal component 14 can include a
proximal portion including a cavity 21 configured to receive the
intermediate component 16 and a distal portion configured to
threadably engage an instrument, e.g., a driver shaft, inserted
therethrough. The proximal portion can have a larger diameter than
the distal portion, as in the illustrated embodiment. The proximal
portion of the inner lumen 15 can have a size configured to allow
the intermediate component 16 to be received at least partially
therein, as discussed further below.
[0047] The distal portion of the distal component's inner lumen 15
can include at least one internal thread 19 therein. The thread 19
can be a single, continuous thread as in the illustrated embodiment
that extends around the inner lumen 15, or the thread 19 can
include a plurality of threads, as will be appreciated by a person
skilled in the art. In an exemplary embodiment, the internal thread
19 can be located in a distal portion of the inner lumen 15 of the
distal component 14 and it can extend from an intermediate position
within the inner lumen 15 and extend to a distal end thereof. In
this way, the inner lumen of the anchor 10 can have a proximal,
unthreaded region and a distal, threaded region. The internal
thread 19 can facilitate insertion of the anchor 10 into a bone
hole by allowing an instrument such as a driver to threadably
engage the anchor 10 in a substantially fixed position during
insertion of the anchor 10 into a bone hole. The internal thread 19
can also facilitate insertion of the intermediate component 16 into
the distal component 14, e.g., into the cavity 21, by allowing the
distal component 14 to be movable relative to the intermediate
component 16. As discussed further below, an instrument such as a
driver threadably engaged with the internal thread 19 can be moved
proximally and/or distally to correspondingly move the distal
component 14 proximally and/or distally relative to a remainder of
the anchor 10, e.g., to the proximal and intermediate components
12, 16. When the instrument and the distal component 14 are moved
together proximally relative to the proximal and intermediate
components 12, 16, the intermediate component 16 can be received
within the distal component's inner lumen 15.
[0048] The distal component 14 can be configured to selectively
radially expand, such as by inserting the intermediate component 16
at least partially therein, e.g., by positioning at least a portion
of the intermediate component 16 distally into the inner lumen 15
of the distal component 14. In an exemplary embodiment, a
substantial portion of the intermediate component 16 can be
received within the inner lumen 15 of the distal component 14. The
anchor 10 can therefore be configured to be movable between a
first, undeployed configuration, shown in FIG. 1, and a second,
deployed configuration, shown in FIG. 2, in which the distal
component 14 is radially expanded as compared to the distal
component 14 in the first configuration. In this way, the distal
component 14 can be configured to be slidably movable within a bone
hole when the anchor 10 is disposed in the bone hole in the
undeployed configuration, and to radially expand and press against
a bone surface of the bone hole when the anchor 10 is disposed in
the bone hole in the deployed configuration, thereby helping to
prevent the anchor 10 from being removed therefrom. The anchor 10
can also be configured to engage the bone hole in a second,
independent way. The anchor 10 can be configured to threadably
engage the bone surface of the bone hole, e.g., with the threads 18
formed on the external surface of the proximal portion 12, thereby
helping to retain the anchor 10 within the bone hole until the
anchor 10 is manually removed or bio-absorbed.
[0049] The distal component 14 can be configured to receive any
amount of the intermediate component 16. In an exemplary
embodiment, a greater amount of the intermediate component 16 can
be disposed within the distal component 14 when the anchor 10 is in
the deployed configuration than when the anchor 10 is in the
undeployed configuration. When the anchor 10 is in the deployed
configuration, one or more holes or openings 24a, 24b of the
intermediate component 16, discussed further below, can be
contained within the distal component 14, as shown in FIG. 2, which
can help compress one or more sutures between the distal and
intermediate components 14, 16.
[0050] In an exemplary embodiment, the distal component 14 can be
configured to radially expand such that it changes in height and in
width. The anchor 10 can have a first longitudinal length L1 in the
undeployed configuration and can have a second, smaller
longitudinal length L2 in the deployed configuration. Similarly,
the distal component 14 can have a first width W1 and a first
height H1 when the anchor 10 is in the undeployed configuration and
can have a second, larger width W2 and a second, smaller height H2
when the anchor 10 is in the undeployed configuration. The first
width W1 of the distal component 14 can be a maximum width of the
distal component 14 in the anchor's undeployed configuration and
can be equal to or less than a minimum outer width W3 of the
proximal component 12. In this way, the distal component 14 can be
configured to be slidably movable within a bone hole when the
anchor 10 is disposed therein in the undeployed configuration to
allow the anchor 10 to be disposed distally far enough into the
bone hole to allow the threads 18 formed on the proximal component
12 to begin to engage the bone. Similarly, the second width W2 of
the distal component 14 can be equal to or greater than the minimum
outer width W3 of the proximal component 12. The distal component
14 can therefore be configured to press against a bone surface of
the bone hole when the anchor 10 is disposed therein in the
deployed configuration, thereby helping to prevent the anchor 10
from being removed therefrom. The anchor 10 can also be configured
to help prevent the anchor 10 from being removed from the bone hole
in a second, independent way. The anchor 10 can be configured to
threadably engage the bone surface of the bone hole, e.g., with the
threads 18 formed on the external surface of the proximal portion
12, thereby helping to retain the anchor 10 within the bone hole
until the anchor 10 is manually removed or bio-absorbed.
[0051] The intermediate component 16 can also have a variety of
sizes, shapes, and configurations, and it can be cannulated, as
mentioned above, and can have an external surface free of
bone-engaging surface features. Being free of bone-engaging surface
features can allow the intermediate component 16 to be freely
slidable within a bone hole. The intermediate component 16 can
taper distally to facilitate insertion of the intermediate
component 16 within the inner lumen 15 of the distal component 14,
e.g., within the cavity 21. As in the illustrated embodiment, the
intermediate component 16 can have a dome or bullet shape with a
tapered or rounded end of the intermediate component 16 being
directed distally. At least a proximal portion of the inner lumen
15 of the distal component 14 can have a shape configured to
receive at least a portion of the intermediate component 16,
similar to a ball and socket joint in which the intermediate
component 16, or ball, can be received within the distal component
14, or socket. The size of the intermediate component 16 can vary,
but in an exemplary embodiment, the intermediate component 16 can
have a maximum width W4 that is greater than a width W5 of the
inner lumen 15 of the distal portion 14 in at least a proximal
portion thereof, thereby allowing the intermediate component 16 to
radially expand the distal component 14 as the intermediate
component 16 is received in the inner lumen 15 of the distal
component 14. In an exemplary embodiment, the maximum width W4 of
the intermediate component 16 can be equal to the width of the
distal component 14 when the anchor 10 is in the undeployed
configuration, e.g., the width W4 can equal the first width W1, and
can be less than the width of the distal component 14 when the
anchor 10 is in the deployed configuration, e.g., the width W4 can
be less than the second width W2.
[0052] The intermediate component 16 can include the one or more
openings 24a, 24b formed therethrough, which can each be in
communication with the inner lumen 17 of the intermediate component
16, and hence be in communication with the inner lumen of the
anchor 10. Each of the one or more openings 24a, 24b can be located
in an intermediate portion of the intermediate component 16 between
proximal and distal ends of the intermediate component 16. In an
exemplary embodiment, each of the openings 24a, 24b can be located
distal to a distal end of the proximal component 12 when the
proximal component 12 is fully received within the inner lumen 17
of the intermediate component 16. In other words, each of the
openings 24a, 24b can be located distal to the internal stop
surface 16i formed within the intermediate component 16. By being
located distal to a distal position of the proximal component 12,
the openings 24a, 24b can help ensure that any sutures passing
therethrough pass through an entire longitudinal length of the
proximal component 12, e.g., through an entire longitudinal length
of the proximal component's inner lumen 13, which can help maximize
an amount of the suture(s) that are engaged by the threads 18 and
engaged between the distal and intermediate components 14, 16, as
discussed further below.
[0053] One or more of the openings 24a, 24b can be configured as a
tunnel extending all the way through the intermediate component 16
to pass through opposed sidewalls thereof, as both the openings
24a, 24b are in the illustrated embodiment. Additionally or
alternatively, one or more of the openings 24a, 24b can be
configured as a tunnel having one end passing through a sidewall of
the intermediate component 16 and another end terminating at the
inner lumen 17 of the intermediate component 16.
[0054] The one or more openings 24a, 24b can each be configured to
receive at least one suture to allow the at least one suture to
pass therethrough. The one or more openings 24a, 24b can thus be
configured to allow a suture positioned within the inner lumen 17
of the intermediate portion 16, and hence within the inner lumen of
the anchor 10, to exit the intermediate portion 16, and hence exit
the anchor 10. In other words, the one or more openings 24a, 24b
can each allow a suture coupled to the intermediate portion 16 to
enter the inner lumen 17 of the intermediate component 16 through a
proximal end thereof and to extend through a partial length of the
inner lumen 17 of the intermediate portion 16 before exiting the
intermediate portion 16, and hence exiting the inner lumen of the
anchor 10, through the one or more openings 24, 24b, e.g., through
a selected one of the openings 24a, 24b.
[0055] Although the intermediate component 16 in the illustrated
embodiment includes two openings 24a, 24b, the intermediate
component 16 can include one opening formed therethrough or a
plurality of openings formed therethrough. Providing a plurality of
openings through the intermediate component 16 can provide more
options for positioning of a suture outside the anchor 10 by
allowing the suture to be passed through a selected one of the
plurality of openings. Providing a plurality of openings through
the intermediate component 16 can allow each of the openings to
accommodate one suture of a plurality of sutures coupled to the
anchor 10. The number of openings formed through the intermediate
component 16 can therefore equal a number of sutures coupled to the
anchor 10. Although, the number of sutures coupled to the anchor 10
can be different than the number of openings, such as in the
embodiment illustrated in FIGS. 1 and 2 where a number of openings
24, 24b, e.g., two, exceeds a number of sutures 20, e.g., one,
coupled to the anchor 10. Additionally, even if an anchor includes
a plurality of openings and has a plurality of sutures coupled
thereto, each of the openings can have any number of sutures
passing therethrough, e.g., zero, one, two, etc.
[0056] The anchor 10 can include a stop mechanism configured to
prevent an elongate shaft, e.g., an insertion shaft of a driver,
from being inserted distally through the anchor 10 beyond a certain
amount. In an exemplary embodiment, the inner lumen 13 of the
proximal component 12 can include a shaft stop surface 13s
configured as such a stop mechanism.
[0057] The inner lumen of the anchor 10 can have different
cross-sectional shapes along a longitudinal length thereof. The
different cross-sectional shapes can help allow the proximal
component 12 to be rotatable, e.g., about the longitudinal axis A
of the anchor 10, relative to the distal and intermediate
components 14, 16. Proximal to the shaft stop surface 13s, the
inner lumen of the anchor 10 can have a first cross-sectional
shape, and it can have a second, different cross-sectional shape
distal to the stop surface 13s. The inner lumen 13 of the proximal
component 12 can therefore have different cross-sectional shapes
along a longitudinal length thereof. Although the first and second
cross-sectional shapes can vary, in an exemplary embodiment, the
first cross-sectional shape can be hexagonal, and the second
cross-sectional shape can be circular.
[0058] As discussed further below, the anchor 10 can be configured
to have one or more sutures 20 extending through at least a portion
of the cannulated interior of the anchor 10. Although only one
suture 20 is illustrated in FIGS. 1 and 2 as being coupled to the
anchor 10, a plurality of sutures can be simultaneously coupled to
the anchor 10. Additionally, the at least one suture 20 is shown in
FIGS. 1 and 2 as a non-folded single strand, but any one or more
sutures coupled to the anchor 10 can be folded any number of times,
e.g., doubled over. Although the at least one suture 20 is shown
passing through one of the openings 24b, the at least one suture 20
and/or any other sutures coupled to the anchor 10 can instead, as
mentioned above, pass through the other opening 24a.
[0059] Whether the anchor 10 is in the undeployed or deployed
configuration, the proximal portion 12 of the anchor 10 can be
configured to compress the one or more sutures 20 between an
external surface of the proximal portion 12 and a bone surface of a
bone hole in which the anchor 10 is disposed, thereby helping to
secure the one or more sutures 20, and hence any soft tissue
attached thereto, in place relative to the bone hole. When the
anchor 10 is in the undeployed configuration, the one or more
sutures 20 can be configured to be freely movable or slidable
through at least the distal and intermediate components 14, 16.
When the anchor 10 is in the deployed configuration, the one or
more sutures 20 can be configured to be in a locked or fixed
position relative to at least the distal and intermediate
components 14, 16. The anchor 10 can therefore be configured to
help securely hold the one or more sutures 20, and hence any soft
tissue attached thereto, in place relative to the bone hole in two
independent ways: with a cooperative relationship between the
proximal component 12 and the bone surface of the bone hole, and
with a cooperative relationship between the distal and intermediate
components 14, 16. The at least one suture 20 can therefore be less
likely to slip or migrate after the suture anchor has been
implanted into bone and soft tissue attached to the at least one
suture 20 has been positioned relative to the bone.
[0060] A compression fit between the distal and intermediate
components 14, 16 can help hold the anchor 10 in the deployed
configuration. Additionally or alternatively, the anchor 10 can
include a retention feature configured to hold the distal and
intermediate components 14, 16 in a fixed position relative to one
another when the anchor is in the deployed configuration, e.g.,
when the distal component is radially expanded. The retention
feature can have a variety of sizes, shapes, and configurations.
Exemplary embodiments of retention features include a snap lock and
a protrusion and complementary depression, hole, or opening
configured to receive the protrusion.
[0061] FIGS. 4 and 5 illustrate an exemplary embodiment of a suture
anchor 100 that includes a retention feature. The anchor 100 can be
configured similar to the anchor 10 of FIGS. 1-3 and can include a
proximal component 112, a distal component 114, and an intermediate
component 116 positioned between the proximal component 112 and the
distal component 114. FIG. 4 illustrates the anchor 100 in an
undeployed configuration, and FIG. 5 illustrates the anchor 100 in
a deployed configuration in which the distal component 114 is
radially expanded from its configuration when the anchor 100 is in
the undeployed configuration.
[0062] As in this illustrated embodiment, the retention feature can
be formed on the distal and intermediate components 114, 116 and
can include a barb 101 at a distal end of the intermediate
component 116 and a retention surface 103 formed within the inner
lumen 115 of the distal component 114 that is configured to engage
and retain the barb 101. The barb 101 can form a distal portion of
the intermediate component 116, as in the illustrated embodiment.
The barb 101 can include one or more retention hooks 105a, 105b
extending proximally from a distal base 107 of the barb 101.
Although the anchor 100 in this embodiment includes two retention
hooks 105a, 105b, the anchor 100 can include any number of
retention hooks. The barb 101 can be configured to be movable
between a proximal, disengaged position when the anchor 100 is in
the undeployed configuration and a distal, retained position when
the anchor 100 is in the deployed configuration. The intermediate
component 116 can be configured to move the barb 101 from the
proximal position to the distal position by pushing the barb 101
distally as the intermediate component 116 is advanced distally
into the inner lumen 115 of the distal component 114. When the
intermediate component 116 has advanced a sufficient amount into
the inner lumen 115, the retention hooks 105a, 105b can be
configured to engage and hook the retention surface 103, thereby
helping to retain the intermediate component 116 at least partially
disposed within the distal component 114.
[0063] FIGS. 6 and 7 illustrate another exemplary embodiment of a
suture anchor 200 that includes a retention feature. The anchor 200
can be configured similar to the anchor 10 of FIGS. 1-3 and the
anchor 100 of FIGS. 4 and 5 and can include a proximal component
212, a distal component 214, and an intermediate component 216
positioned between the proximal component 212 and the distal
component 214. FIG. 6 illustrates the anchor 200 in an undeployed
configuration, and FIG. 7 illustrates the anchor 200 in a deployed
configuration in which the distal component 214 is radially
expanded from its configuration when the anchor 200 is in the
undeployed configuration. FIG. 7 also illustrates an embodiment in
which the intermediate component 216 of the anchor 200 can be
disposed entirely within the distal component 214 when the distal
component 214 is radially expanded therearound, e.g., when the
anchor 200 is in the deployed configuration.
[0064] As in this illustrated embodiment, the retention feature can
be formed on the proximal and distal components 212, 214 and can
include one or more protrusions 201 formed on the distal component
214 that can be configured to engage corresponding depressions 203
formed on the proximal component 212. Although the anchor 200 in
this embodiment includes two protrusions 201 and two depressions
203, the anchor 200 can include any number of protrusions and
depressions.
[0065] As mentioned above, the suture anchors discussed herein can
be used to anchor soft tissue to bone. While the following method
is described in connection with attaching soft tissue to bone, the
methods and devices disclosed herein can be used in a variety of
medical procedures for anchoring one structure to another.
Additionally, although the following exemplary method for securing
soft tissue to bone illustrated in FIGS. 8-10 is discussed with
reference to the suture anchor 10 of FIGS. 1-3, any of the suture
anchors and disclosed herein can be similarly used to anchor one
structure to another, e.g., soft tissue to bone.
[0066] To attach soft tissue to bone, a bore, bone hole, or bone
tunnel can be formed in bone of a patient. The bone hole can be
pre-formed, such as by using a drill, an awl, a punch instrument,
etc., as will be appreciated by a person skilled in the art.
Alternatively, the bone hole can be formed simultaneously with
advancement of a suture anchor into bone and simultaneously with
threadable engagement of the anchor therewith, such as by using a
self-awling or self-tapping driver and/or self-awling or
self-tapping anchor. A diameter of the bone hole can vary. In an
exemplary embodiment, it can be slightly less than a maximum outer
diameter W6 of the anchor 10 and be substantially equal to the
minimum outer width W3 of the proximal component 12, to be disposed
within the bone hole, and a length of the bone hole can be the same
as or slightly greater than a length of the anchor 10. The bone
hole can extend fully through cortical bone 50 to allow the suture
anchor to be fully engaged through the thickness of the cortical
bone 50. The bone hole 50 can also extend into cancellous bone 52
located underneath the cortical bone 50.
[0067] As shown in FIG. 8, the anchor 10 in the undeployed
configuration, without the distal component 14 being radially
expanded, can have one or more sutures 56 coupled thereto by
extending at least partially through the inner lumen thereof. The
one or more sutures 56 can be coupled to the anchor 10 before or
after the bone hole is formed in the bone. Although the suture 56
is shown passing through one of the openings 24b, the suture 56
and/or any other sutures coupled to the anchor 10 can instead, as
mentioned above, pass through the other opening 24a. In an
exemplary embodiment, the suture 56 can be coupled to the anchor 10
after the bone hole 50 is formed. A soft tissue 58 can be coupled
to the suture 56, e.g., by passing the suture 56 through the soft
tissue 58, before or after the suture 56 is coupled to the anchor
10, but in an exemplary embodiment, the suture 56 can be coupled to
the soft tissue 58 prior to the suture 56 being passed into the
inner lumen of the anchor 10. Although only one suture 56 is
illustrated in FIGS. 8-10 as being coupled to the anchor 10 and to
the soft tissue 58, as mentioned above, a plurality of sutures can
be simultaneously coupled to the anchor 10. Additionally, the
suture 56 is shown in FIGS. 8-10 as being a double-folded single
strand, but any one or more sutures coupled to the anchor 10 can be
folded any number of times, e.g., doubled over.
[0068] The suture 56 can be passed into the anchor 10 through a
proximal end thereof, e.g., through the proximal end of the
proximal component 12, and through one of the openings 24a, 24b
formed through the intermediate component 16 to exit the anchor 10.
The suture 56 can therefore be loaded onto the anchor 10 to
position a first length of the suture 56 within the inner lumen of
the anchor 10, e.g., within the inner lumens 13, 17 of the proximal
and intermediate components 12, 16, and to position a second length
of the suture 56 external to the anchor 10 such that the second
length can be positioned adjacent to the threaded external surface
of the proximal component 12.
[0069] The suture 56 can be coupled to the anchor 10 before or
after an instrument (not shown) configured to advance the anchor 10
into bone is inserted through the inner lumen of the anchor 10. In
an exemplary embodiment, the anchor 10 can be pre-loaded onto a
distal end of the instrument with the suture 56 coupled to the
anchor 10 and to the instrument, such as by extending into an inner
lumen thereof. Generally, the instrument can include an elongate
insertion shaft configured to be advanced through the inner lumen
of the anchor 10 such that the instrument threadably engages the
internal thread 19 in the distal component 14 and a distal tip of
the instrument extends distally beyond the anchor 10, e.g., passes
outside the anchor 10 through the distal end of the distal
component's inner lumen 15.
[0070] FIG. 11 illustrates an exemplary embodiment of an instrument
configured to advance the anchor 10 into bone in the form of a
driver 60. The driver 60 can include an elongate insertion shaft
having a shape corresponding to the inner lumen of the anchor 10.
The shaft can therefore have different cross-sectional shapes along
a longitudinal length thereof. As in the illustrated embodiment, a
proximal portion 60p of the shaft can have a first cross-sectional
shape, e.g., hexagonal, and a distal portion 60d of the shaft can
have a second cross-sectional shape, e.g., circular. The proximal
portion 60p of the shaft can be configured to be positioned in the
inner lumen 13 of the proximal component 12 and abut the shaft stop
surface 13s such that the proximal portion 60p of the shaft can be
located entirely proximal to the distal and intermediate components
12, 16. The distal portion 60d of the shaft can be configured to be
positioned in the inner lumens 13, 15, 17 of the proximal, distal,
and intermediate components 12, 14, 16 such that a distal tip 60t
of the shaft extends distally beyond the anchor 10. The distal
portion 60d can include an external thread 62 configured to
threadably engage the internal thread 19 of the distal component's
inner lumen 15 to threadably engage the anchor 10 and hold the
shaft in a substantially fixed axial position relative thereto
during insertion of the anchor 10 into the bone hole.
[0071] The distal tip 60t of the driver 60 can be configured as a
penetrating tip, e.g., be tapered, pointed, and/or sharpened, which
can facilitate formation of a bone hole and/or facilitate
penetration of the shaft, and hence a suture anchor coupled
thereto, into bone. The driver 60 can therefore be configured to be
self-awling or self-tapping in which a bone hole need not be
pre-formed prior to inserting the driver shaft, and a suture anchor
coupled thereto, into bone. In this illustrated embodiment, the
distal tip 60t is tapered, pointed, and sharpened. As mentioned
above, a suture anchor can be configured as self-awling or
self-tapping, and when such an anchor is used with a self-awling or
self-tapping driver, can further facilitate insertion of the driver
and the anchor into bone.
[0072] In an exemplary embodiment, the anchor 10 can be pre-loaded
onto the elongate shaft of the driver with the suture 56 coupled to
the anchor 10 and the driver. The suture 56 can extend within the
inner lumen of the anchor 10, e.g., within the proximal component's
inner lumen 13 and the intermediate component's inner lumen 17,
along an external surface of the driver, and/or the suture 56 can
extend within an inner passageway (not shown) of the driver. In an
exemplary embodiment, the suture 56 can be located external to the
driver at least within the anchor 10, which can facilitate removal
of the driver from within the anchor 10 without unintentionally
damaging or repositioning the suture 56 and the soft tissue 58
attached thereto.
[0073] The anchor 10 having the driver extending therethrough can
be advanced distally into bone such that the anchor 10 is in a
pre-threaded, undeployed configuration in which a distal portion of
the anchor 10 is disposed within a bone hole formed in the bone
without the anchor's external thread 18 engaging the bone, as shown
in FIG. 8. The anchor 10 can be advanced distally into the bone to
be in the pre-threaded, undeployed configuration by pushing the
anchor 10 in a distal direction without rotating the anchor 10
because the external surfaces of the distal and intermediate
components 14, 16 lack bone engaging-surface features and can slide
within the bone hole. The anchor 10 can be advanced into the bone
until just before the external thread 18 begins to engage the
cortical bone 50, e.g., until the distal surface 12m of the
proximal portion 12p abuts a proximal surface 50p of the cortical
bone 50, as also shown in FIG. 8. The distal and intermediate
components 14, 16 can therefore be disposed within the cortical
bone 50 and/or cancellous bone 52 distal to the proximal surface
50p of the cortical bone 50. Depending on a particular patient's
anatomy and the sizes of the distal and intermediate components 14,
16, when the anchor 10 is in the pre-threaded, undeployed
configuration, the intermediate component 16 can be disposed
entirely within the cortical bone 50, and at least a portion of the
distal component 14 can be disposed within the cancellous bone
52.
[0074] When the anchor 10 is in the pre-threaded, undeployed
configuration, a portion of the suture 56 can pass through the
opening 24b and can be positioned external to the anchor 10. In
this way, as shown in FIG. 9, when the anchor 10 is advanced
distally to move from the pre-threaded, undeployed configuration to
a threaded, undeployed configuration, shown in FIG. 9, the external
thread 18 can engage the bone, and the suture 56 can be compressed
between the bone surface of the bone hole and an external surface
of the anchor 10, e.g., between the bone wall and the external
surface of the proximal portion 12 of the anchor 10.
[0075] Prior to threadably engaging the anchor 10 with the bone,
the suture 56 and the soft tissue 58 can be tensioned to position
the soft tissue 58 to an optimal position relative to the bone. The
suture 56 and the soft tissue 58 can be tensioned by pulling the
suture 56 by hand and/or by tool. As the anchor 10 is threaded into
the bone, the tension can be maintained by hand and/or by tool,
e.g., by engaging the suture 56 onto a suture-retaining member (not
shown) formed on the shaft of the driver. The suture-retaining
member can have a variety of configurations, such as a
compression-fit groove, a clip, a clamp, a post, an adhesive,
etc.
[0076] The driver can be rotated about a longitudinal axis thereof,
which can be the same axis as the anchor's longitudinal axis A, to
drive the proximal portion 12 of the anchor 10 into the bone. As
mentioned above, the different cross-sectional shapes of the
anchor's inner lumen and corresponding different cross-sectional
shapes of the driver's shaft can allow the proximal portion 12 of
the anchor 10 to be rotated relative to the distal and intermediate
components 14, 16. The suture 56 and the soft tissue 58 can
therefore remain in substantially the same position as the anchor
10 is threaded into the bone. The helices of the external thread 18
and the internal thread 19 can rotate in opposite directions, e.g.,
one clockwise and the other counterclockwise. In this way, rotating
the driver to rotate the proximal portion 12 into the bone can
rotate the proximal portion 12 relative to the distal and
intermediate components 14, 16 without unthreading the shaft thread
54 from the distal component's internal thread 19.
[0077] The anchor 10 can be inserted any depth into the bone, such
as substantially flush or sub-flush with a proximal end of the bone
hole. The shaft can have one or more depth markings (not shown)
printed or otherwise formed on an external surface thereof. The
depth marking(s) can be configured to facilitate visual assessment
of the shaft's location within a body of a patient. In an exemplary
embodiment, the shaft can include a distal depth marking such as a
line around a perimeter of the shaft. The distal depth marking can
help visually indicate when the anchor 10 has been inserted
substantially flush or sub-flush with the proximal end of the bone
hole. In an exemplary embodiment, the driver can be rotated until
the distal depth marking is substantially flush with the proximal
end of the bone hole, thereby indicating that the suture anchor 10
has been inserted substantially sub-flush into the bone hole with
the thread 18 engaging the cortical bone 50, as shown in FIG. 9.
The suture 56 can therefore be compressed between the anchor 10 and
the cortical bone 50 along an entire longitudinal length of the
proximal component 12. As also shown in FIG. 9, the anchor 10 can
be in the undeployed configuration with the proximal component 12
positioned entirely within the cortical bone 50 and with the distal
and intermediate 14, 16 components positioned entirely below the
cortical bone 50, e.g., entirely within the cancellous bone 52. The
proximal component 12 can, however, be at least partially disposed
within the cancellous bone 52.
[0078] With the anchor 10 threadably engaging the bone, the suture
56 can be compressed between the bone and anchor 10 to help hold
the suture 56 and the soft tissue 58 in a fixed position relative
to the bone. As mentioned above, the suture 56 can also be
compressed between the distal and intermediate components 14, 16 to
further help hold the suture 56 and the soft tissue 58 in a fixed
position relative to the bone. As also mentioned above, the distal
component 14 can be configured to move relative to the intermediate
component 16 to compress the suture 56 therebetween. In an
exemplary embodiment, the driver can be pulled proximally to move
the distal component 14 proximally relative to the intermediate
component 16, as well as relative to the proximal component 12, to
radially expand the distal component 14 as the intermediate
component 16 is advanced therein. The anchor 10 can therefore be
moved from the undeployed configuration to the deployed
configuration, as shown in FIG. 10. The driver can be pulled
proximally such that it can be moved without rotation to pull the
distal component 14 proximally, which can help prevent the driver
from becoming threadably disengaged from the distal component
14.
[0079] Once the distal component 14 is advanced over the
intermediate component 16, the driver can be rotated, e.g., about a
longitudinal axis thereof and/or about the longitudinal axis A of
the anchor, to threadably disengage the driver from the internal
thread 19 of the distal component 14. The driver can then be
removed from the inner lumen of the anchor 10, e.g., by sliding the
driver out of the anchor 10. Excess trailing ends of the suture 56
extending proximally from the bone hole can trimmed and,
optionally, be secured together.
[0080] FIGS. 12-16 illustrate another exemplary embodiment of a
method for securing soft tissue to bone, described with reference
to the anchor 100 of FIGS. 4 and 5. For clarity of illustration,
suture 156 coupled to the anchor 100 is not shown with any soft
tissue attached thereto, and the suture 156 is omitted from FIGS.
13 and 15.
[0081] The anchor 100 can be advanced into cortical bone 250 and/or
cancellous bone 252 similar to that discussed above regarding FIGS.
8-10 in which the anchor 10 is implanted in bone. FIG. 12
illustrates the anchor 100 in a pre-threaded, undeployed
configuration in which the distal and intermediate components 114,
116 have been driven into a bone hole 154 before an external thread
118 formed on the proximal component 112 engages the bone. FIG. 13
illustrates the anchor 100 in the pre-threaded, undeployed
configuration with an exemplary embodiment of a driver 70 inserted
through the inner lumen of the anchor 100.
[0082] The driver 70 can include an outer driver shaft 72 and an
inner deployment shaft 74. The inner deployment shaft 74 can
including a penetrating tip, as in the illustrated embodiment, to
facilitate penetration of the driver 70 into bone. The outer driver
shaft 72 can have a first cross-sectional shape, e.g., hexagonal,
corresponding to a first cross-sectional shape, e.g., hexagonal, of
the anchor's inner lumen. The outer driver shaft 72 can therefore
be configured to abut a shaft stop surface 113s within an inner
lumen 113 of the proximal component 112. The inner deployment shaft
74 can have a second cross-sectional shape, e.g., circular,
corresponding to a second cross-sectional shape, e.g., circular, of
the anchor's inner lumen. The inner deployment shaft 74 can include
an external thread 76 configured to threadably engage an internal
thread 119 formed in the distal component 114. The outer deployment
shaft 72 can be configured to rotate independent of the inner
deployment shaft 74, which can facilitate threading of the proximal
component 112 into bone without disengaging the internal thread 119
from the inner deployment shaft's thread 76. The shaft threads 76,
119 can therefore have helices rotating in the same direction.
Alternatively, the outer deployment shaft 72 can be configured to
rotate with of the inner deployment shaft 74, in which case the
shaft threads 76, 119 can have helices rotating in opposite
directions.
[0083] FIG. 14 illustrates the anchor 100 moved from the
pre-threaded, undeployed configuration to a threaded, undeployed
configuration in which the proximal component 112 is threadably
engaged with the bone and is disposed at least partially within the
cortical bone 250. As in the illustrated embodiment, the proximal
component 112 can be substantially flush or sub-flush with a
proximal end of the bone tunnel 154 and can extend distally beyond
the cortical bone 250 to be partially located in the cancellous
bone 250. FIG. 15 illustrates the anchor 100 in the threaded,
undeployed configuration with the driver 70 inserted through the
inner lumen of the anchor 100.
[0084] The anchor 100 can be moved from the threaded, undeployed
configuration to a deployed configuration by moving the driver 70
proximally to radially expand the distal component 114. FIG. 16
illustrates the anchor 100 in the deployed configuration with the
driver 70 removed therefrom. As shown in FIG. 16, when the
intermediate component 116 has been advanced into the distal
component 114, a gap or open space 158 previously occupied by the
distal component 114 within the bone hole 154 can be formed at a
distal end of the bone hole 154. As with any of the suture anchor
discussed herein, a material can be injected or otherwise inserted
through the inner lumen of the anchor 100 and into the open space
158. The material can be configured to further help retain the
anchor 100 within the bone hole 154 and/or further facilitate
healing. The material can be, for example, a bone-growth promoting
material, a sealant, an adhesive, and combinations thereof. The
trailing ends of the suture 156 extending proximally from the bone
hole can be secured together and the excess trimmed.
[0085] One skilled in the art will appreciate further features and
advantages of the invention based on the above-described
embodiments. Accordingly, the invention is not to be limited by
what has been particularly shown and described, except as indicated
by the appended claims. All publications and references cited
herein are expressly incorporated herein by reference in their
entirety.
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