U.S. patent application number 16/737073 was filed with the patent office on 2020-05-07 for soft anchors with soft eyelets.
The applicant listed for this patent is ARTHREX, INC.. Invention is credited to Kyle ANDERSON, E. Lyle CAIN, JR., Thomas DOONEY, JR., Peter J. DREYFUSS, Jeffrey R. DUGAS, Peter J. MILLETT.
Application Number | 20200138429 16/737073 |
Document ID | / |
Family ID | 48998478 |
Filed Date | 2020-05-07 |
View All Diagrams
United States Patent
Application |
20200138429 |
Kind Code |
A1 |
DREYFUSS; Peter J. ; et
al. |
May 7, 2020 |
SOFT ANCHORS WITH SOFT EYELETS
Abstract
Soft anchor constructs and methods for soft tissue to bone
repairs. The soft anchors may be knotted or knotless constructs.
The soft anchors include a body formed of various soft materials
(including, but not limited to, suture) and provided in various
shapes and configurations that confer the anchors the ability to be
easily inserted within bone tunnels or sockets and be bunched up
within the bone tunnels or sockets. At least one closed loop or
soft eyelet is attached to the soft anchor to allow additional
sliding strands and/or shuttle/pull devices (suture passing
devices) to pass through the eyelet and aid in the knotted or
knotless fixation of tissue to bone.
Inventors: |
DREYFUSS; Peter J.; (Naples,
FL) ; DOONEY, JR.; Thomas; (Naples, FL) ;
CAIN, JR.; E. Lyle; (Birmingham, AL) ; DUGAS; Jeffrey
R.; (Vestavia Hills, AL) ; ANDERSON; Kyle;
(Birmingham, MI) ; MILLETT; Peter J.; (Vail,
CO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ARTHREX, INC. |
Naples |
FL |
US |
|
|
Family ID: |
48998478 |
Appl. No.: |
16/737073 |
Filed: |
January 8, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15262593 |
Sep 12, 2016 |
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16737073 |
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13961716 |
Aug 7, 2013 |
9463011 |
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15262593 |
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61684418 |
Aug 17, 2012 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00526
20130101; A61B 2017/0406 20130101; A61F 2002/0852 20130101; A61B
2017/0414 20130101; A61B 17/0485 20130101; A61F 2002/0888 20130101;
A61B 2017/0417 20130101; A61F 2002/087 20130101; A61B 17/0401
20130101; A61F 2/0811 20130101; A61F 2/08 20130101; A61B 2017/0477
20130101 |
International
Class: |
A61B 17/04 20060101
A61B017/04; A61F 2/08 20060101 A61F002/08 |
Claims
1. A surgical system, comprising: an inserter including a forked
portion; and a soft anchor looped over the forked portion of the
inserter, wherein the soft anchor includes a sheath and a first
flexible suture strand passed through at least one cannulation of
the sheath, wherein the sheath is comprised of polyester and the
first flexible suture strand is comprised of ultrahigh molecular
weight polyethylene (UHMWPE).
2. The surgical system as recited in claim 1, wherein the soft
anchor is made exclusively of suture-based materials.
3. The surgical system as recited in claim 1, wherein the first
flexible suture strand passes through the sheath multiple
times.
4. The surgical system as recited in claim 1, wherein the first
flexible suture strand passes through the sheath at multiple
locations of the sheath.
5. The surgical system as recited in claim 1, wherein the soft
anchor includes a second flexible strand attached to the
sheath.
6. The surgical system as recited in claim 5, wherein the second
flexible strand is comprised of ultrahigh molecular weight
polyethylene (UHMWPE).
7. The surgical system as recited in claim 1, wherein the sheath is
configured to move from a first, non-compressed position to a
second, compressed position in response to tensioning the first
flexible suture strand.
8. The surgical system as recited in claim 7, wherein the second,
compressed position is a bunched-up position.
9. The surgical system as recited in claim 1, wherein the sheath is
a woven, braided, or knitted suture structure.
10. The surgical system as recited in claim 1, wherein the soft
anchor extends along a first side of the forked portion, through a
slot formed in the forked portion, and along a second side of the
forked portion.
11. The surgical system as recited in claim 1, wherein a first
width of the sheath is larger than a second width of the first
flexible suture strand.
12. The surgical system as recited in claim 1, wherein the inserter
includes a handle, a shaft, and the forked portion.
13. The surgical system as recited in claim 12, wherein the forked
portion is provided at a distal tip of the shaft.
14. The surgical system as recited in claim 1, comprising a knot
formed in the first flexible suture strand.
15. The surgical system as recited in claim 1, wherein at least a
portion of the first flexible suture strand protrudes outside of
the sheath at a location of the sheath that is spaced apart from
opposing open ends of the sheath.
16. A method, comprising: preparing a hole in a bone; pushing a
soft anchor into the hole with a forked portion of an inserter,
wherein the soft anchor includes a sheath and a flexible suture
strand passed through the sheath; and tensioning the flexible
suture strand, thereby moving the soft anchor from a first,
non-compressed position to a second, compressed, bunched-up
position inside the hole.
17. The method as recited in claim 16, wherein the sheath is
comprised of polyester and the flexible suture strand is comprised
of ultrahigh molecular weight polyethylene (UHMWPE).
18. The method as recited in claim 16, wherein the flexible suture
strand passes through the sheath at multiple locations of the
sheath.
19. The method as recited in claim 16, wherein the soft anchor
extends along a first side of the forked portion, through a slot
formed in the forked portion, and along a second side of the forked
portion.
20. The method as recited in claim 16, wherein at least a portion
of the flexible suture strand protrudes outside of the sheath at a
location of the sheath that is spaced apart from opposing open ends
of the sheath.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This is a continuation of U.S. patent application Ser. No.
15/262,593, filed on Sep. 12, 2016, which is a divisional of U.S.
patent application Ser. No. 13/961,716, filed on Aug. 7, 2013, now
U.S. Pat. No. 9,463,011, which claims the benefit of U.S.
Provisional Application No. 61/684,418, filed on Aug. 17, 2012, the
disclosures of which are incorporated by reference in their
entireties herein.
FIELD OF THE INVENTION
[0002] The present invention relates to surgical devices and, in
particular, to soft suture-based anchors.
BACKGROUND OF THE INVENTION
[0003] When soft tissue such as a ligament or a tendon becomes
detached from a bone, surgery is usually required to reattach or
reconstruct the tissue. Often, a tissue graft is attached to the
bone to facilitate regrowth and permanent attachment. Techniques
and devices that have been developed generally involve tying the
soft tissue with suture to an anchor or a hole provided in the bone
tissue. Knotless suture anchors, such as the two piece Arthrex
PushLock.RTM. anchor, disclosed in U.S. Pat. No. 7,329,272, have
been developed to facilitate tissue fixation to bone.
[0004] It would be desirable to provide a suture construct that may
be knotted or knotless and that is formed essentially of a soft
material such as suture (or suture-based materials or other soft
materials and/or compositions) with the ability to be inserted into
a bone socket but also having tying, sliding sutures that are
allowed to run/slide freely. Also needed is a soft, suture-based
anchor that is knotless and is provided with an independent, soft
suture eyelet and a self-cinching mechanism connected to both the
independent, soft suture eyelet and to the suture-based anchor.
SUMMARY OF THE INVENTION
[0005] The present invention provides soft anchors which are
designed to be inserted into the bone and which have flexible
strand(s) within the body of the anchors. The soft anchors may be
knotted or knotless constructs. The soft anchors include a body
formed of various soft materials (including, but not limited to,
suture) and provided in various shapes and configurations that
confer the anchors the ability to be easily inserted within bone
tunnels or sockets and be bunched up within the bone tunnels or
sockets. At least one closed loop or soft eyelet is attached to the
soft anchor to allow additional sliding strands and/or a
shuttle/pull device (suture passing device) to pass through the
eyelet and aid in the knotted or knotless fixation of tissue to
bone.
[0006] These and other features and advantages of the invention
will be more apparent from the following detailed description that
is provided in connection with the accompanying drawings and
illustrated exemplary embodiments of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] FIG. 1 illustrates a soft anchor according to an exemplary
embodiment of the present invention.
[0008] FIG. 2 illustrates the soft anchor of FIG. 1 with at least
one sliding suture passing through the eyelet of the anchor.
[0009] FIGS. 3 and 4 illustrate additional views of the soft anchor
of FIG. 1 (showing the positioning of the eyelet relative to the
body of the anchor).
[0010] FIG. 5 illustrates a soft anchor according to another
exemplary embodiment of the present invention (with a self-cinching
loop passed around tissue and attached to the body of the
anchor).
[0011] FIGS. 6-11 illustrate subsequent steps of a method of
forming the soft anchor of FIG. 5 (with a self-cinching construct)
and of employing the soft anchor for attachment of soft tissue to
bone.
[0012] FIG. 12 illustrates a soft anchor according to another
exemplary embodiment of the present invention.
[0013] FIG. 13 illustrates the soft anchor of FIG. 12 with at least
one sliding suture passing through the eyelets of the anchor and
secured to an inserter instrument.
[0014] FIGS. 14 and 15 illustrate steps of forming a soft anchor
according to yet another exemplary embodiment of the present
invention (a knotless soft suture with a self-cinching loop).
[0015] FIGS. 16-20 illustrate subsequent steps of a method of
attaching soft tissue to bone with the soft anchor of FIG. 15 and
according to an exemplary embodiment of the present invention.
[0016] FIG. 21 illustrates an exemplary embodiment of an inserter
of the present invention.
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0017] The present invention provides surgical systems and methods
for knotted or knotless soft tissue (ligament, tendon, graft, etc.)
repair and fixation, such as fixation of soft tissue to bone. The
surgical systems of the present invention include fixation devices
in the form of soft anchors that are formed of various soft
materials and are provided in various shapes and configurations
that confer the anchors the ability to be easily inserted within
bone tunnels or sockets and be bunched up within the bone tunnels
or sockets. The soft anchors are formed essentially of soft
materials such as yarns, fibers, filaments, strings, fibrils,
strands, sutures, etc. or combinations of such soft materials. The
soft materials may be synthetic or natural materials, or
combinations of synthetic and natural materials, and may be
degradable or non-degradable or combinations thereof.
[0018] At least one closed loop or soft eyelet is attached to the
body of the anchor to allow additional sliding flexible strands
and/or shuttle/pull devices (suture passing devices) to pass
through the eyelet and aid in the fixation of tissue to bone.
[0019] The soft anchors may be knotted or knotless. As detailed
below, an exemplary knotted soft anchor includes (i) an anchor
body, (ii) a securing strand that extends through at least a
portion of the body and forms a closed loop and/or at least one
soft eyelet, and (iii) a tissue attachment strand (knot tying
suture) that attaches to the closed loop and/or the at least one
soft eyelet, and secures the tissue to be fixated by having knots
tied in.
[0020] As detailed below, an exemplary knotless soft anchor
includes (i) an anchor body, and (ii) a securing strand that
extends through at least a portion of the body, the securing strand
having, at one end, a closed loop and/or at least one soft eyelet
and, at a portion of the other end, a self-cinching assembly (a
spliced loop). The self-cinching assembly (splice loop) may be
formed with a shuttle/pull device (for example, a suture passing
instrument such as a wire suture passer) attached to the
construct.
[0021] The anchors have a body in the form of any sleeve/sheath
structure which may be provided with open or closed ends, or with
at least one open end or with at least one opening on the side of
the body for the securing strand to exit the body on a sidewall of
the body (i.e., not at the end of the body). The anchors may also
have a tubular shape, partially tubular shape, or may be in the
form of a hollow shape construct. The anchors have a body which may
be a woven, braided or knitted structure, and/or may be formed of
yarns, fibers, filaments, sutures or similar materials, or
combinations of such materials. The anchor body is typically
without a core. In exemplary-only and non-limiting embodiments, the
soft anchors include a body that is formed essentially of suture.
The suture-based anchor body may be any woven, braided structure
including, but not limited to, suture formed of polyester,
polyethylene or any other suture material. If the anchor is
knotless, the securing strand is preferably formed of a coreless
suture to accommodate the splicing.
[0022] The securing strand that attaches to the anchor body may be
any type suture, including coreless sutures that form a closed
loop, or two eyelets each at one end of the strand (i.e., in a
dumbbell shape), or an eyelet at one end and a shuttle/pull device
(a suture passing instrument such as a wire suture passer) at the
other end to form a spliced loop. The securing strand can extend
through the open ends of the sleeve/sheath or through an opening in
the sleeve body. Once the anchor body is inserted into a bone
tunnel or socket it bunches up securing the anchor in the tunnel.
The securing strand does not necessarily have to be engaged to
accomplish the bunching of the anchor.
[0023] The tissue attachment strand may be any flexible strand (for
example, suture) and may be pre-assembled to hold the anchor onto
an inserter. The tissue attachment strand is the strand that
attaches to the tissue and gets knots tied in it, and that also
holds the construct to an inserter instrument to keep the construct
at the bottom of the bone hole/socket. For the knotless anchors,
and as described below, the securing strand becomes the tissue
attachment strand (this strand does not require a knot to secure
the tissue, the splice accomplishes the locking). For the knotless
anchors, an attachment suture is used to hold the anchor onto the
inserter during the insertion process and then removed once the
anchor is in the bone hole/socket.
[0024] Referring now to the drawings, where like elements are
designated by like reference numerals, FIGS. 1-20 illustrate
exemplary soft anchors 100, 200, 100a, 200a of the present
invention that are formed essentially of a flexible, soft material
such as suture (for example, a polyester sheath) or any other
similar soft materials. Soft anchor 100 and 100a are exemplary
knotted embodiments. Soft anchors 200 and 200a are exemplary
knotless embodiments.
[0025] FIGS. 1-4 illustrate soft anchor 100 formed essentially of
anchor body 10 in the form of a flexible material 10 (for example,
a braided suture such as a polyester sheath/sleeve/tube 10) and a
securing strand 11 which forms a soft independent closed loop 15
attached to the anchor body 10. Closed loop 15 may be formed by
tying a knot or splicing. For example, FIGS. 3 and 4 show closed
loop 15 formed by splicing while FIGS. 1 and 2 show the closed loop
formed by providing knot 12 at the top in the middle of the
U-shaped structure. The anchor body 10 may be in the form of any
sleeve/sheath structure or tubular structure which may be provided
with open or closed ends 10a, 10b (FIG. 1), or with at least one
open end or with at least one closed end. The anchor body 10 may be
a woven, braided or knitted structure, and/or may be formed of
yarns, fibers, filaments, sutures or similar materials, or
combinations of these materials, including, but not limited to,
suture formed of polyester.
[0026] Securing strand 11 is a flexible strand that is passed
through at least a portion of the length of the flexible material
10. The securing strand 11 attaches to the anchor body 10 and may
be any type of suture, including coreless sutures that form closed
loop 15. The securing strand 11 can extend through the open ends
10a, 10b of the sleeve/sheath 10 or through an opening in the
sleeve body. The securing strand 11 may assist in bunching up the
anchor body 10 (sleeve/sheath) once the anchor body 10 is inserted
into a bone tunnel or socket. The securing strand 11 may be also
attached to the anchor body 10 in a suture-through-suture technique
(with a needle, for example). Strand 11 may be an exemplary
FiberWire.RTM. or TigerWire.RTM. suture 11, and may circle back to
exit through the sheath 10, creating a closed independent
loop/eyelet 15. The strand forming the closed loop/eyelet 15 exits
on one side of the anchor body and enters on the other side of the
anchor body, so that there is a gap in the anchor where the closed
loop is exposed. Loop/eyelet 15 is a soft loop/eyelet. In an
exemplary-only embodiment, the securing strand 11 (the
FiberWire.RTM. or TigerWire.RTM. suture 11) may be passed through
the anchor body 10 at different locations and as desired, for
example, at predetermined insertion points on the length of the
anchor body. The end of the FiberWire.RTM. or TigerWire.RTM. suture
11 is brought back to reenter the anchor body 10 to form the closed
loop 15.
[0027] FIG. 2 illustrates soft anchor 100 with at least another
flexible strand 40 (a tissue attachment strand 40) passing through
the closed loop 15. The tissue attachment strand 40 may be any
flexible strand (for example, suture) and may be pre-assembled with
the anchor on an inserter (similar to inserter 60 shown in FIG.
13). The tissue attachment strand 40 is the strand that attaches to
the tissue to get fixated/reapproximated and gets knots tied in it
(and also holds the construct to the inserter to keep the construct
at the bottom of the bone hole/socket).
[0028] When the soft anchor 100 is inserted into a bone
socket/tunnel employing an inserter instrument (for example, a
pusher provided with a forked tip), the body of the anchor 100
bunches up within the bone socket/tunnel. However, the tissue
attachment suture 40 remains free to slide untangled, to allow
completion of the soft tissue repair, for example, to be passed
through or around the soft tissue to be attached to the bone.
[0029] FIGS. 3 and 4 illustrate additional views of the soft anchor
100 of the present invention showing in more detail the securing
strand 11 forming spliced closed loop 15 contained within the body
of the exemplary sheath 10 (tubular construct 10).
[0030] A method of tissue repair with the exemplary construct 100
(soft knotted anchor 100) of the present invention comprises inter
alia the steps of: (i) drilling/punching a hole in bone; (ii)
inserting soft anchor 100 into the hole in the bone to compress the
soft anchor into the hole; and (iii) tying free suture 40 around or
through tissue and completing the repair tying knots.
[0031] FIG. 5 illustrates another embodiment of the present
invention. Soft anchor 200 is similar to the soft anchor 100 in
that it also contains an anchor body 10 formed essentially of a
soft material (for example, coreless suture such as a UHMWPE
braided sheath/sleeve) and a securing strand 11 forming soft
independent loop 15 attached to anchor body 10. However, the soft
anchor 200 is a knotless--and not knotted--construct that contains
a self-cinching construct 50 attached to the loop 15 (and to the
braided sheath 10), as shown in FIG. 5. The self-cinching construct
50 may be formed prior or after the lodging of the soft anchor into
bone, and eliminates the formation of any knots and the need for a
tissue attachment strand (such as strand 40 of FIG. 2).
[0032] Self-cinching construct 50 may be formed by passing a length
of flexible material 51 (for example, a cinching suture 51) through
the length of the anchor body 10 (braided sheath/sleeve 10) two
times with a needle, as shown in FIG. 5. The ends of strand 51 are
then tied together to form a knot 52, closed loop 54 and closed
loop 15 (both loops having a similar perimeter). The perimeter of
loop 54 is fixed.
[0033] One end of the strand 51 is then passed through the loops
15, 54 and around (or through) tissue to be fixated, and then
spliced through the remaining end, to form splice 53 and adjustable
cinching loop 55 (shown in FIG. 5). The perimeter of cinching loop
55 is adjustable, to allow the construct to be self-cinching and to
adjust the tension on the tissue to be fixated.
[0034] The assembly created by the cinching loop 55 uses the suture
loop 15 (eyelet 15) as a turning point for application of force and
to direct the cinching suture 51 into the construct in the correct
manner.
[0035] FIGS. 6-11 illustrate details of forming the self-cinching
construct 50 with cinching loop 55 of soft, knotless anchor 200 and
methods of attaching tissue to bone by employing such construct.
FIGS. 6-8 illustrate in more detail the splicing of the cinching
suture 51, at the splice region 53. FIG. 9 illustrates the
insertion of soft, knotless anchor 200 into drilled hole 99 formed
within bone 90. FIGS. 10 and 11 illustrate the self-cinching
construct 50 with cinching loop 55 of soft, knotless anchor 200
passed around tissue 95 which is to be secured to bone 90. By
pulling on the free end of the cinching suture 51, the perimeter of
the adjustable, cinching loop 55 decreases around the tissue 95 and
approximates the tissue 95 to bone 90, at the desired location and
under the desired tension.
[0036] FIGS. 12 and 13 illustrate yet another exemplary embodiment
of a soft anchor 100a of the present invention. Soft anchor 100a is
similar to the soft anchor 100 of FIGS. 1-4 in that it is also a
knotted anchor (i.e., allows attachment of a tissue attachment
strand that will secure tissue by tying knots) but differs in that
the securing strand 11 forms two small eyelets/loops 15a, 15b that
allow tissue attachment strand 40 to attach thereto and pass
slidingly there through. Anchor body 10 of soft anchor 100a is
similar to anchor body 10 of anchor 100 in that it is also formed
essentially of a soft material (for example, coreless suture such
as a polyester braided sheath/sleeve) that may have a
sleeve/sheath/tubular configuration with open or closed ends and/or
may be a hollow construct. Anchor body 10 of soft anchor 100a may
be any woven, knitted, or braided structure formed of various
yarns, fibers and/or filaments, and typically without a core.
[0037] Securing strand 11 could be any type of suture (including
coreless suture) that has a dumbbell configuration with two small
eyelets 15a, 15b (as shown in FIG. 12). Strand 11 can extend
through the cannulation of the sleeve/sheath 10 and through the
open ends 10a, 10b, or through an opening in the sleeve body 10.
The securing strand 11 accommodates the tissue attachment strand
40.
[0038] FIG. 13 illustrates tissue attachment strand 40 passed
through eyelets 15a, 15b of securing strand 11 and further secured
to inserter 60 (pre-assembled with the anchor to inserter 60).
Strand 40 attaches to the tissue to be fixated and forms knots for
securing the tissue repair for the knotted embodiments. A more
detailed depiction of inserter 60 is shown in FIG. 21.
[0039] FIGS. 14 and 15 illustrate yet another embodiment of soft
anchor 200a of the present invention. Anchor 200a is similar to
soft anchor 200 of FIG. 5 in that it is also a knotless soft anchor
which has an anchor body 10 similar to anchor body 10 of soft
anchor 200. However, anchor 200a differs from anchor 200 in that
the securing strand 11 is provided with only one eyelet 15a
(located at one end of the strand) and preloaded with a
shuttle/pull device 70 (a suture passer 70 such as a nitinol
passing wire 70) attached at the portion of the strand that exits
the anchor body (for example, at a portion of the other end of the
strand). Suture passer 70 is pre-assembled to the securing strand
11 as shown in FIG. 14 and will form a splice loop 55a shown in
FIG. 15 during the repair. Securing strand 11 could be any flexible
strand such as suture or suture tape, preferably without a core to
make the splice easier. The securing strand 11 becomes the tissue
attachment suture, but without requiring a knot to secure the
tissue since the splice accomplishes the locking. An attaching
suture is also attached to the anchor to provide for pre-assembly
of the construct to the inserter 60. The attaching suture is
removed once the anchor is placed in the bone hole/socket.
[0040] The free end 11a of strand 11 is passed through eyelet 71 of
the suture passer 70 (in the direction of arrow A of FIG. 14) and
then the suture passer 70 is pulled to allow strand 11 to pass
through itself at the region 53 (FIG. 15) and form splice 53 and
self-cinching adjustable flexible loop 55a (FIG. 15). The perimeter
of flexible loop 55a is adjustable, to allow the construct to be
self-cinching and to adjust the tension on the tissue to be
fixated.
[0041] An exemplary knotless method of fixation of soft tissue to
bone with soft anchor 200a of the present invention comprises inter
alia the steps of: (i) after insertion of anchor 200a and removal
of inserter 60, suture 11 is passed around or through tissue 95
desired to be fixed; (ii) next, free end 11a of strand 11 is fed
through wire eyelet 71; (iii) wire end 72 is pulled which causes
the construct to be created by causing the free end 11a of strand
11 to pass through eyelet 15a, followed by the free end 11a of
strand 11 to pass through splice area 53 and form adjustable
knotless closed loop 55a; and (iv) wire 70 is discarded and the
free end 11a of strand 11 is tensioned to desired repair
approximation.
[0042] FIGS. 16-20 illustrate subsequent steps of a method of
tissue fixation (tissue approximation/repair) with exemplary soft
anchor 200a of the present invention. Inserter 60 (FIG. 16) pushes
soft anchor 200a within bone hole 99 formed in bone 90. FIG. 17
shows the sheath 10 (anchor body 10) bunched up within the bone
hole 99, i.e., from a non-compressed, initial length L.sub.1 (FIG.
16) to a compressed, bunched up, final length L.sub.2 (FIG.
17).
[0043] Soft anchor 200a is provided pre-assembled with shuttle/pull
device 70 (nitinol passing wire 70) attached to strand 11 (at
splice area 75) and passing through eyelet 15a. Free end 11a of
strand 11 is passed through the nitinol wire eye 71 (in the
direction of arrow A) and around exemplary soft tissue 95 to be
attached to bone 90, as shown in FIG. 17. Tensioning on the wire
end 72 pulls the suture end 11a through the construct (FIG.
18).
[0044] Wire passer 70 is removed and tension is applied on the
suture end 11a of strand 11, as shown in FIG. 19 (by pulling in the
direction of arrow B) to form adjustable closed loop 55a that is
tightened on and around tissue 95. FIG. 20 illustrates final repair
300 with sheath 10 (anchor body 10) bunched up within the bone hole
99 and securing strand 11 around soft tissue 95 approximated to
bone 90 by adjustable, knotless self-cinching flexible spliced loop
55a.
[0045] The materials employed for the formation of the soft anchors
100, 200, 100a, 200a may be loosely braided polyester sutures,
which may be braided with at least one other fiber, natural or
synthetic, to form lengths of suture material. The suture-based
anchors 100, 200, 100a, 200a may be also formed of suture tape. The
suture tapes may have the same, uniform width or may have different
widths, and may comprise the same or different materials.
[0046] The flexible, soft material forming the soft anchors 100,
200, 100a, 200a may be also formed of suture tape or a combination
of suture and tape, a stiff material, or combination of stiff and
flexible materials, depending on the intended application.
Alternatively, the flexible material may be formed in the shape of
a folding tube suture anchor which may contain textile or
homogenous material. The folding tube anchor may be formed of a
tube (cylinder or sleeve/sheath) provided with apertures/holes to
allow the flexible strands to pass therethrough. When the tube is
inserted into a bone tunnel/socket and when tension is applied, the
tube folds and lodges into the bone tunnel/socket but the tying,
sliding sutures remain free for additional manipulation and
surgical procedures.
[0047] As noted above, the soft anchors 100, 200, 100a, 200a may be
formed of any soft materials such as yarns, fibers, filaments,
strings, fibrils, strands, sutures, etc. or combinations of such
soft materials. The soft materials may be woven, braided, knitted
or otherwise interlocked with each other to achieve the soft
anchors of the present invention. The soft materials may be
synthetic or natural materials, or combinations of synthetic and
natural materials. The anchors 100, 200, 100a, 200a may be in the
form of any sleeve/sheath/tubular structure which may be provided
with open or closed ends, or with at least one open end or with at
least one closed end. The anchors 100, 200, 100a, 200a may also
have a tubular or cylindrical shape, partially tubular shape, a
sleeve-like shape, or may be in the form of any hollow or partially
hollow shape construct provided with a cannulation extending at
least along a portion of the length of the structure. The anchors
100, 200, 100a, 200a may be woven or braided structures, or may be
formed of yarns, fibers or similar materials, or combinations of
these materials, that are joined/interlocked together by any known
method in the art. In the exemplary-only embodiments above, the
soft anchors 100, 200, 100a, 200a of the present invention are
suture-based anchors formed essentially of suture such as braided
polyester or polyethylene.
[0048] As noted above, the soft anchors 100, 200, 100a, 200a
detailed above may be also employed with a self-cinching suture
mechanism that could be incorporated into the implant/anchor. Once
the anchor is deployed, the surgeon would simply pull on the
self-cinching suture strands to firmly secure the device and
compress the tissue (for example, the rotator cuff). The soft
anchors 100, 200, 100a, 200a could be utilized for multiple
additional indications such as, for example, AC joint
reconstruction, syndesmosis reconstruction, quad/patellar tendon
rupture repair, hallux-valgus repair, and any other tendon repair
to bone.
[0049] The soft anchors 100, 200, 100a, 200a detailed above may be
also employed in conjunction with additional various knotted and/or
knotless fixation devices (or combination of such knotted and
knotless fixation devices), such as hard suture anchors to secure,
for example, a medial row on rotator cuff repairs.
[0050] The flexible strands 11, 40 employed for the formation of
the soft anchors 100, 100a, 200, 200a may be high-strength sutures,
such as the high strength suture sold by Arthrex, Inc. of Naples,
Fla. under the registered tradename TigerWire.RTM. or
FiberWire.RTM., which is disclosed and claimed in U.S. Pat. No.
6,716,234, the entire disclosure of which is incorporated by
reference in its entirety herewith. FiberWire.RTM. suture is formed
of an advanced, high-strength fiber material, namely ultrahigh
molecular weight polyethylene (UHMWPE), sold under the tradenames
Spectra (Honeywell) and Dyneema (DSM), braided with at least one
other fiber, natural or synthetic, to form lengths of suture
material. The preferred FiberWire.RTM. suture includes a core
within a hollow braided construct, the core being a twisted yarn of
UHMWPE.
[0051] The flexible strands may be also formed of suture tape or a
suture chain. The suture tapes may have the same, uniform width or
may have different widths, and may comprise the same or different
materials.
[0052] Although the present invention has been described in
connection with preferred embodiments, many modifications and
variations will become apparent to those skilled in the art. While
preferred embodiments of the invention have been described and
illustrated above, it should be understood that these are exemplary
of the invention and are not to be considered as limiting.
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