U.S. patent application number 10/385037 was filed with the patent office on 2003-09-04 for multi-anchor suture.
Invention is credited to Oberlander, Michael A..
Application Number | 20030167072 10/385037 |
Document ID | / |
Family ID | 26848621 |
Filed Date | 2003-09-04 |
United States Patent
Application |
20030167072 |
Kind Code |
A1 |
Oberlander, Michael A. |
September 4, 2003 |
Multi-anchor suture
Abstract
A multi-anchor suture is provided which comprises at least two
anchors and at least one suture attached to each anchor. The
multiple anchors are inserted into a patient's bone and the suture
connecting the anchors facilitates reattachment of soft tissue to
the bone. Also provided is a method of attaching soft tissue to
bone using the inventive multi-anchor suture.
Inventors: |
Oberlander, Michael A.;
(Alamo, CA) |
Correspondence
Address: |
David L. Schwartz
Wallenstein & Wagner, Ltd.
53rd Floor
311 South Wacker Drive
Chicago
IL
60606-6630
US
|
Family ID: |
26848621 |
Appl. No.: |
10/385037 |
Filed: |
March 10, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10385037 |
Mar 10, 2003 |
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09645671 |
Aug 24, 2000 |
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6554852 |
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60151423 |
Aug 25, 1999 |
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Current U.S.
Class: |
606/232 ;
606/304; 606/329; 606/75; 606/916 |
Current CPC
Class: |
A61B 2017/044 20130101;
A61B 2017/0409 20130101; A61B 17/0642 20130101; Y10S 606/916
20130101; A61B 2017/0427 20130101; A61B 17/0401 20130101; A61B
17/0682 20130101; A61B 2017/0647 20130101; A61B 2017/0438 20130101;
A61B 2017/0412 20130101; A61B 2017/0445 20130101; A61B 2017/0648
20130101 |
Class at
Publication: |
606/232 ; 606/72;
606/73; 606/75 |
International
Class: |
A61B 017/04; A61B
017/58 |
Claims
We claim:
1. A device for attaching soft tissue to bone during arthroscopic
surgery comprising: two anchors that are capable of being at least
partially inserted into a bone, wherein each anchor has a region
adapted to reduce the possibility that the anchor will disengage
from the bone; and a knotless suture attached to each anchor.
2. The device of claim 1 wherein the region adapted to reduce the
possibility that the anchor will disengage from the bone comprises
barbs.
3. The device of claim 2 wherein the suture is attached to at least
one barb.
4. The device of claim 2 wherein the barbs bend slightly during
insertion of the anchor into the bone.
5. The device of claim 1 wherein the region adapted to reduce the
possibility that the anchor will disengage from the bone comprises
threads.
6. The device of claim 1 wherein the anchors each have a length and
the suture has a length, and wherein the length of the suture is
less than the length of at least one anchor.
7. The device of claim 1 wherein the anchors are relatively firmly
embedded in the bone.
8. The device of claim 1 wherein the suture and both anchors are
intregal.
9. The device of claim 1 wherein at least one anchor is
non-cannulated.
10. The device of claim 1 wherein the anchors are cannulated.
11. The device of claim 1 wherein the anchors are held in place
during initial insertion into the bone by guide wires.
12. The device of claim 1 wherein the suture is attached to each
anchor at a single position on each anchor.
13. The device of claim 1 wherein the two anchors are substantially
identical.
14. A method for attaching soft tissue to bone during arthoscopic
surgery comprising: inserting at least two anchors partially into a
bone; and connecting the anchors with a knotless suture to maintain
a soft tissue adjacent to the bone.
15. The method of claim 14 comprising the further step of: applying
force to the anchors to insert the anchors into the bone at least
approximately 5-6 millimeters.
16. The method of claim 14 comprising the further step of: applying
force to the anchors at least until the suture is taut.
17. The method of claim 14 wherein the anchors are space apart in
the bone approximately 5 millimeters.
18. The method of claim 14 wherein the anchors are cannulated.
19. The method of claim 14 wherein at least one anchor is inserted
into the soft tissue.
20. A device for re-attaching soft tissue to bone comprising: two
anchors for insertion into a tissue and a bone; and a suture which
is eccentrically attached to each anchor without the use of a knot.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of Provisional
Application Serial No. 60/151,423, filed Aug. 25, 1999. This
application is a continuation of co-pending prior U.S. application
Ser. No. 09/645,671, filed Aug. 24, 2000.
FIELD OF INVENTION
[0002] The present invention generally relates to the field of
medical devices and procedures. More specifically, the invention
relates to devices and methods for the re-attachment of soft tissue
to bone.
BACKGROUND OF THE INVENTION
[0003] Re-attachment of soft tissue to bone is often required in
surgery. During athletic endeavors, work, falls, or repetitive use
and aging, a ligament or tendon may be pathologically avulsed or
torn from its normal insertion site. Soft tissue to bone
re-attachment is then needed to return to normal or near normal
function to the limb or joint. Such re-attachment may be necessary
anywhere within the body, including, by way of example but not by
way of limitation, in the wrist, ankle, knee, or shoulder.
Re-attachment is considered important for several reasons. First,
it helps ensure proper healing. When a ligament has been torn away
from its normal position of attachment to bone it may become bathed
in synovial fluid, which is a poor healing environment. Second,
even if the ligament does heal, it may heal in a stretched out or
elongated position, possibly leading to residual joint laxity or
dysfunction. Surgical repair may thereby become necessary to return
proper structure and function to the joint. The present invention
relates to the fixation of soft tissue to bone at its proper
location and is suitable for use in many common surgical procedures
including, by way of example but not limitation, rotator cuff
repair, bankart repair, ligament avulsions from bone (knee, ankle,
shoulder, wrist) and many others known to those of skill in the
art. While the invention is suitable for use in open surgery, it is
particularly useful for arthroscopic surgery.
[0004] The present invention is more fully described below. Many
publications are cited herein and the entire disclosure of each
such cited reference is hereby incorporated by reference in its
entirety, and should be considered a part of this disclosure as if
set forth in its entirety at the point of reference.
[0005] Several approaches for attaching soft tissue to bone exist
in the art. Each suffers disadvantages.
[0006] One approach requires transossous suture tunnels. The use of
such tunnels is described more fully in Shoulder Reconstruction by
Charles S. Neer II (W. B. Saunders Co. 1990). Although appropriate
for some cases, the use of bone tunnels can be difficult and
generally requires large open incisions.
[0007] Another approach, which is especially useful in closed,
arthroscopic or endoscopic settings, involves the use of suture
anchors that allow quick fixation without the need for extensive
exposure. A common problem among many such anchor systems is that
they require knot tying of the attached sutures after the suture
anchors are inserted into the bone and the sutures placed through
the soft tissue.
[0008] One example of a suture anchor assembly is set forth in U.S.
Pat. No. 5,441,502, which describes an anchor assembly having a
pre-threaded suture positioned at the posterior of the anchor.
After the suture anchor is properly deployed in the bone, the
associated suture extends upwardly through the soft tissue. The
free ends of the sutures are then tied to secure the soft tissue to
the bone.
[0009] An important limitation of this prior art is the requirement
for knot tying. Knot tying itself is time consuming and technically
demanding, especially in an arthroscopic environment, where surgery
is done in small spaces through small incisions. In addition, knot
slippage or suture breakage during knot tying could lead to
unsecured attachment of the soft tissue to bone, potentially
adversely affecting the healing process.
[0010] Some non-suture anchor systems have been described, such as
in U.S. Pat. Nos. 5,840,078, 5,013,316, and 4,532,926. However,
fixation with these devices may not be as secure as that achieved
with sutures. In addition, non-suture anchors offer fewer points of
fixation, typically providing only one point of soft tissue to
device fixation per device, and one point of device to bone
fixation per device.
[0011] Staple-like devices have been used surgically to eliminate
the need for suturing outside of the soft-tissue to bone context.
U.S. Pat. Nos. 4,994,073 and 5,089,009 describe surgical skin
fasteners that eliminate the need for suturing when joining
adjacent portions of soft tissue. The fastener comprises a backspan
and two prongs depending therefrom. The skin fasteners are mostly
useful for joining two edges of body tissue together or for joining
layers of tissue both laterally or laminarly as required in skin
grafting. Other surgical tacks made of bioabsorbable material such
as the bankart tack (Bionix) and the Suretek (Acufex) leave hard
polylactic or polyglycolic acid portions of the tack exposed. These
exposed hard polymers pose potential injury to the articular
cartilage or if broken off, may result in loose bodies, which may
cause further joint deterioration or mechanical symptoms.
[0012] Staple-like devices have also been used for attaching bone
to bone. U.S. Pat. No. 4,994,063 describes a bone staple with two
feet and a central web portion made of rigid material. Portions of
bone on opposite sides of a fracture are compressed toward each
other by inserting the two feet of the staple into each bone
portion and crimping the central web portion of the staple.
[0013] Staple-like devices having large rigid bodies have also been
used to attach artificial soft tissue to bone. U.S. Pat. No.
4,793,335 describes a bone implant composed of a deformable metal
plate and a pair of anchor pins attached to and extending from the
metal plate. The staple described therein is used to hold a tendon
or ligament over a relatively large area. These staples are not
suitable for intra-articular usage because they tend to loosen in
time with cyclical loading of the tissues and may become a loose
object within the joint, causing further injury.
SUMMARY OF THE INVENTION
[0014] The invention relates to devices and methods for
re-attaching soft tissue to bone. The invention is based in part on
the discovery of an assembly comprising at least one suture joining
multiple cannulated or non-cannulated anchors. This invention also
relates to cannulated instruments to apply the suture-anchor
assembly. Although the invention includes within its scope
assemblies comprising multiple sutures or multiple anchors, in one
embodiment a single suture is joined by two cannulated anchors. In
this embodiment, the two cannulated anchors joined by suture can be
easily and precisely inserted over guide wires at an optimal point
of fixation through one larger arthroscopic cannula, thereby
providing a knotless mechanism for attachment of soft tissue to
bone having two points of fixation for a single suture. The
invention thereby avoids the problems of the prior art associated
with knot tying while at the same time providing improved
structural and performance characteristics such as increased number
of points of fixation per suture and facilitated arthroscopic
insertion and placement. The invention also minimizes the risk of a
portion of the device breaking off and becoming loose within the
joint.
[0015] As used herein, the word "re-attach," and all forms thereof
such as "re-attached," "re-attachment," and "re-attaching," is
intended to include not only its ordinary meaning but also the
concept of "attach." Therefore, the term will be understood to
properly describe any situation in which components are being
attached, regardless of whether they had been attached
previously.
[0016] In accordance with one aspect of the present invention, a
system for attaching soft tissue to bone is provided. The system is
composed of one integrated assembly. The integrated assembly is
composed of at least two anchors, each having a region for
insertion into the bone and a region for suture connection and at
least one knotless suture attached to the suture connection region
of each anchor. In one embodiment, at least one or both of the
anchors is cannulated.
[0017] In accordance with another aspect of the present invention,
the assembly includes the suture being attached eccentrically to
the insertion region of at least one of the anchors.
[0018] In accordance with another aspect of the present invention,
the system further includes a gun for firing the assembly.
[0019] In accordance with another aspect of the present invention,
the system further includes a grasper tool having at least one
cannulated barrel.
[0020] In accordance with still another aspect of the present
invention, the system includes an initial anchor impactor tool and
a final impactor tool, each of said tools adapted to apply force to
at least one of the anchors for insertion into soft tissue and/or
bone.
[0021] In accordance with still another aspect of the present
invention, the system for attaching soft tissue to bone includes an
assembly that is composed of at least two anchors, each having a
region for insertion into the bone and a region for suture
connection. The region for suture connection on at least one anchor
includes a rotatable collar that can rotate relative to that anchor
so that the suture is prevented from rotational movement with the
anchor as the anchor is rotated, such as during insertion into the
bone or other areas.
[0022] In accordance with still another aspect of the present
invention, a method for attaching soft tissue to bone is provided.
The method includes inserting at least two guidewires through the
soft tissue and into the bone, inserting at least two anchors along
the guidewires with the anchors being connected by a suture and
thereafter inserting the anchors into the bone.
[0023] In accordance with another aspect of the present invention,
a method for attaching soft tissue to bone is provided that
comprises providing an assembly for attaching soft tissue to bone
wherein the assembly is composed of at least two anchors, each
anchor having an insertion region for insertion into the bone and a
suture region for suture connection and a suture attached to the
suture connection region of each anchor into the bone while the
suture is attached to the suture connection region of each
anchor.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] FIG. 1 is a top view of the preferred embodiment of a
dual-anchor according to the present invention.
[0025] FIG. 2 is a side sectional view of the dual-anchor
embodiment of FIG. 1 taken along line 2-2 of FIG. 1.
[0026] FIG. 3 is a side elevation view, partly in section, of
another dual-anchor embodiment in accordance with the present
invention.
[0027] FIG. 4 is a top view of the dual-anchor embodiment of FIG.
3.
[0028] FIG. 5 is a side elevation view of another dual-anchor
embodiment according to the invention.
[0029] FIG. 6 is a perspective view of the grasper tool according
to the present invention.
[0030] FIG. 7 is a sectional view of the grasper tool of FIG. 6
taken along line 7-7 of FIG. 6.
[0031] FIG. 8 is a side view, partly in section, showing use of the
grasper tool according to the present invention.
[0032] FIG. 9 is a side view, partly in section, showing use of the
drill bit according to the present invention.
[0033] FIG. 10 is a side sectional view showing insertion of the
dual-anchor into the bone according to the present invention.
[0034] FIG. 11 is a side sectional view showing use of an initial
anchor impactor according to the present invention.
[0035] FIG. 12 is a perspective view of the initial anchor impactor
and a final impactor in accordance with the present invention.
[0036] FIG. 13 is a side sectional view showing use of the final
impactor in accordance with the present invention.
[0037] FIG. 14 is a side view, partly in section, of a reattachment
of soft tissue to bone utilizing the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0038] The present invention provides a knotless suture anchor
assembly for use in attaching soft tissue to bone having more
points of fixation per suture than the prior art. Although useful
in an open setting, the assembly of the invention is especially
well suited for use in a closed, or arthroscopic or endoscopic
setting.
[0039] In accordance with the invention, the assembly comprises two
or more anchors. The anchors comprise at least two regions: a
region for insertion into the bone and a region for suture
attachment. The invention encompasses anchors in which the two
regions overlap in their entirety, in part, and not at all.
[0040] The anchors of the invention may be cannulated or
non-cannulated. For ease of positioning and inserting the anchors
in the bone, cannulated anchors are preferred. FIGS. 1 and 2 show
the sectional and side views of the preferred embodiment of the
dual-anchor suture. Dual-anchor suture 10 has two anchors 20. A
typical anchor is approximately 1 to 1.5 centimeters in length and
4-5 millimeters in width. Anchor 20 tapers slightly near its bottom
end but does not need to form a sharp point. In the preferred
embodiment, both anchors 20 are identical but it is understood that
they can be of different dimensions or materials. For cannulated
anchors, round opening 25 may run through the entire body of anchor
20. These may be of star design to facilitate insertion in an
arthroscopic environment.
[0041] On each of the anchors 20, there is at least one barb 40
oriented in a way that facilitates the insertion of the anchors
into soft tissue and bone but prevents the anchors from pulling
out. Barbs 40 are typically 2 millimeters in length. As
illustrated, preferably the barbs are situated at a 45-60 degree
angle from the anchor body. Although only two rows of three barbs
are visible on FIG. 2 on each anchor, additional rows of barbs are
usually present. The preferred number of barbs in each row depends
on the size of each anchor. Generally, making the barbs thicker or
bigger or increasing the number of barbs on an anchor will increase
the probability that the anchor will be firmly imbedded in the
bone, therefore increasing the pull-out strength, but also increase
the size of the hole in the bone.
[0042] As it is shown in the drawings of FIGS. 1 and 2, the anchors
20 are bridged with a suture 30. Suture 30 is typically slightly
shorter than the length of the anchors, approximately 1 centimeter.
The suture can be molded directly into the anchor during
manufacture of the same or otherwise fixed to the anchor prior to
insertion into a patient's bone. The suture may be fixed to each
anchor approximately one-third or one-half of the distance from the
top of the anchor.
[0043] While the dual-anchor suture described above can be
implanted utilizing open surgery procedures, it is within the scope
of this invention to adapt the multi-anchor suture for arthroscopic
use. Arthroscopic surgery is less invasive and promotes faster
healing and recovery for the patient. Multiple anchor systems are
cannulated for arthroscopic use.
[0044] The anchors of the invention need not have a cannula that
extends through the center vertical axis of anchor 20. The anchors
of the invention may have a cannula that is off-center. As
described in detail below, the cannulation of the anchors permits
insertion of an anchor along a guide wire, thereby facilitating
proper placement of the anchor and helping to avoid inadvertent
dropping of the anchor into the surgical wound area.
[0045] The anchors of the invention are able to become well
attached to the bone to prevent inadvertent removal. To facilitate
or strengthen this attachment, the anchors may be conical in shape.
The anchors of the invention may also have other shapes, as shape,
alone, is not the only method within the scope of the invention for
ensuring proper attachment of the anchor to bone. Anchors having
barbs or flanges or threads, and any other protrusion or
invaginations are also within the scope of the invention. In
addition, anchors having a surface coated with an adhesive material
or comprising an adhesive component are also within the scope of
the invention. Any anchor having an outside surface having a shape
or composition that is adapted to adhere to bone is within the
scope of the invention.
[0046] FIGS. 3 and 4 illustrate another example of the dual-anchor
system. Anchors 21 have regions for connection to suture 31 and
regions for tissue insertion. The exterior of anchors 21 have
threads 35 for insertion and fixation in the soft tissue and bone
mass by screwing anchors 21 into the bone mass and/or soft tissue.
As the shape and structure of the anchors of the invention can vary
in unlimited ways, different insertion instruments will be adapted
to facilitate the insertion of the different variations of the
invention into soft tissue and bone.
[0047] As is well within the skill in the art to determine, it may
also be preferable that an anchor of the invention, especially one
having a threaded exterior, also be equipped with a region 48 that
is adapted for receiving an applied torsional force. Such a region,
or portion thereof, may be so adapted to be slotted like the head
of a standard screw, or to be polygonal like an exterior surface of
a standard nut, or to have a polygonal or star shaped cavity
therein, such as the cavity typically found in the head of a screw
that is adapted to receive an Allen wrench, or to have any of the
many other similar shapes well known in the fastener art, or any
other shape that is adapted to receive an applied torsional force.
Preferably, region 48 is star shaped. During twisting of anchor 21,
it is important that suture 30 not wrap around anchor 20 and
weaken, break off or lose some of the effective length of the
suture. In FIG. 3, collar 45 of left anchor 21 is illustrated in
sectional view to show how collar 45 rotates independent of anchor
21. Collar 45 rotates about the anchor so that suture 31 does not
wrap around the anchor during insertion and twisting of the anchor
into the bone. Preferably, collar 45 is made of the same material
as anchor 21. Suture 31 is molded directly into collar 45.
Alternatively, instead of collar 45, suture 31 may form a loop
around anchor 21 that performs a similar function as collar 45
does.
[0048] FIG. 5 illustrates yet another example of the dual-anchor
suture 10. Flexible anchors 22 are in an approximate V-shape and
collapse upon insertion into the bone. In this embodiment, the
suture is fixed to the end of the top barb of each anchor.
[0049] The anchors of the invention include anchors made of
bioabsorbable materials as well as anchors made of
non-bioabsorbable materials. Bioabsorbable materials within the
scope of the invention include polyglycolic acid, polylactic acid,
and co-polymers of polylactic acid and polyglycolic acid. Other
bioabsorbable materials within the scope of the invention are well
known in the art and are described more fully in "Orthopedic
Applications for PLA-PGA Biodegradable Polymers," Arthroscopy Vol.
14: 726-37 (1998), by KA Athanaion, et al. A preferred
bioabsorbable resinous material for constructing the anchors of the
present invention is disclosed in Kaplan et al., U.S. Pat. No.
4,523,591. Non-bioabsorbable materials within the scope of the
invention include stainless steel or titanium. Other
non-bioabsorbable materials are also within the scope of the
invention. If metallic suture anchors are used, to avoid joint
destruction, no metal should protrude from bone or appear in the
articular surface of any joint.
[0050] The anchors of the invention are connected at their
connection regions by one or more sutures. The preferred suture
materials are either non-absorbable or absorbable materials having
long half life. Appropriate suture materials include absorbable
materials such as Vicryl and Panacryl and non-absorbable materials
such as Dexon, Ethibond, and Tevdeck. These materials are available
from commercial sources such as United States Surgical Corp. of
Norwalk, Conn. and Ethicon, a subdivision of Johnson & Johnson
of Rutherford, N.J.
[0051] The suture can be connected eccentrically to the anchors.
The eccentric position of the suture on the anchor will cause at
least the insertion region to rotate or turn when tension is
applied to the anchors. This rotating motion will lock the anchors
into bone, fortifying the affixation of soft tissue to bone.
[0052] An important advantage of the present invention is that no
knot in the suture is necessary. The need for suture knots is
avoided because the sutures of the invention are tethered by more
than one anchor. The problems of knot tying and potential knot
slippage are thereby avoided. In addition, once inserted inside the
exact place, the multi-anchor suture holds the tissue and bone in
place and creates multiple points of fixation--for example, anchors
vertically holding soft tissue to bone and the connecting suture
member forming a horizontal mattress suture. Thus, the invention
provides more than one point of suture to device fixation per
device and more than one point of device to bone fixation per
device.
[0053] In accordance with the invention, the assembly may comprise
two or more anchors and one or more sutures. Assemblies having more
anchors than sutures are within the scope of the invention, as are
assemblies having fewer anchors than sutures, as well as assemblies
having the same number of anchors and sutures. Anchors with
connection regions having larger geometries may be particularly
well suited for use in assemblies having a ratio of sutures to
anchors that is greater than otherwise, especially if greater than
one.
[0054] Although the assembly according to the invention may include
more than two anchors and more than one suture, a fill
understanding of the operation and benefits of the invention may
most easily be grasped from a review of an example having only two
anchors and one suture. Accordingly, instruments for insertion of
anchor assemblies will also be illustrated as those for an assembly
having two anchors and one suture. However, the discussion of this
exemplary assembly is intended only to provide an illustrative
example and is not intended to limit the scope of the claimed
invention in any way. Neither are the instruments for anchor
insertion limited to those adopted for the exemplary anchor
assembly.
[0055] For purposes of the discussion of this example, the
following background information is useful: a bone surface is
prepared for surgery. An area of tendon or ligament avulsion is
exposed and prepared for attachment of soft tissue to bone.
Preparation of the bone surface creates a bleeding bed to ensure an
adequate blood supply and scar tissue formation for proper soft
tissue and bone healing.
[0056] Arthroscopic insertion of the dual-anchor suture may be
performed inside of an arthroscopic cannula. Such arthroscopic
cannulae are well known in the art including, for example, in U.S.
Pat. No. 5,840,078, which describes a soft tissue positioning
instrument. Such cannulae are well known in the art and are readily
available from Arthrex of Naples, Fla., Acufex of Smith &
Nephew, Inc. of Andover, Mass., and Surgical Dynamics of Norwalk,
Conn. The arthroscopic cannula allows insertion of instruments and
anchors without the risk of catching or being wrapped up in soft
tissue. The cannula also may provide an arthroscopic surgical work
area.
[0057] A double cannulated tubular guide, grasper, or trochar is
then inserted telescopically through the arthroscopic cannula.
Appropriate guides are well known in the art and are readily
available from Arthrex, Smith & Nephew, Inc., Linvatec Corp. of
Largo, Fla., and Bionx Implants Inc. of Blue Bell, Pa. The guide
may have spikes at a distal end to hold soft tissue to bone. This
ensures adequate soft tissue capture and exact location of the
suture anchors.
[0058] FIG. 6 shows a perspective view of grasper 32 adapted for a
dual-anchor suture of the invention. A pair of cannulated barrels
36 are joined on top of grasper body 37. The barrels 36 can also be
fixed below the grasper body 37. Grasper 32 has a jaw 34 at the
distal end to grasp soft tissue at a certain location.
[0059] FIG. 7 is a sectional view of the grasper adapted for the
current invention. The pair of barrels 36 are cannulated to allow
guide wires 38 to go through. There need be sufficient clearance
between barrels 36 and jaw 34 to permit insertion of wires 38. The
two barrels 36 are at a small distance apart from each other. This
distance can be approximately 6 mm, depending on the diameter of
each anchor and the length of the suture. This distance will allow
sufficient horizontal bone bridge between two anchors.
[0060] Turning now to FIG. 8, grasper 32 is used to control the
location of soft tissue 70. A pair of guide wires 38, or K-wires,
are then inserted into soft tissue 70 and bone 60 through the
tubular guides or the double barrels connected with a grasper. Such
guide wires are well known in the art and are readily available
from DePuy OrthoTech of Tracy, Calif. The guide wires are drilled
into bone to a pre-marked line on the wires, typically about 1.5 to
2.0 centimeters from the end of the wires (and thus, 1.5 to 2.0
centimeters into the bone). Alternatively, the wires may be
attached to the bone by means other than drilling, such as by
taping. This preliminarily secures the soft tissue to the bone and
will facilitate insertion of the anchors in the bone mass.
[0061] As illustrated in FIG. 9 cannulated drill 72 bit may then be
inserted over guide wires 38 and used to bore into the surface of
the bone 60 in the area where the guide wire is inserted thereby
forming a bore in the bone that is adapted to receive the anchors.
Typically, the bone is bored to a depth of approximately 8
millimeters. A drill bit may be used over each guide wire 38.
Appropriate drill bits and drill mechanisms also are well known in
the art and are readily available from Arthrex, Bionx Implants,
Inc., and Innovasive Devices, Inc. of Marlborough, Mass.
Alternatively, no bore may be needed. The drill bit will also have
a scribe marking to ensure a sufficient channel for insertion of
the anchor.
[0062] FIG. 10 illustrates the cannulated suture anchors being
inserted over the guide wires 38 and into the bores. Opening 25 on
each end anchor 20 is slightly larger than the cross section of
wires 38. It is understood that although opening 25 and wire 38
preferably have a circular cross section, any cross-sectional
shapes will work, including square and elliptical, as long as
anchor 20 can fit over wire 38. Anchors 20 slide down wire 38 into
position. Barbs 40 may bend slightly during insertion of the anchor
into the bone. A pair of cannulated tamps can help seat the
dual-anchor suture 10 and counter-sink the anchors. Cannulated
tamps are well known in the art and are readily available from
Bionx Implants Inc. and Acufex of Smith & Nephew, Inc.
[0063] Alternatively, an initial anchor impactor is adapted for the
current invention. FIG. 11 shows use of an initial anchor impactor
100 and FIG. 12 shows a side view of impactor 100. The initial
impactor 100 has a tubular body 104 that is double cannulated for
passing through a pair of guide wires 90. The initial impactor 100
has an extended protrusion platform 102 at its distal end. Although
FIG. 12 shows platform 102 on one side of the tubular body 104,
this platform can be on either or both sides of the tubular body
104. In addition, platform 102 can be of any size or shape as long
as it allows a mallet to tap the initial impactor 100 down to help
insertion of the suture anchors. A region of the initial impactor
100 is shaped to fit the top of the suture anchors, allowing even
pressure on the anchors in direction D. Initial impactors are made
of strong materials suitable for surgical use such as 316 L
stainless steel or other similar metal alloy.
[0064] An initial anchor impactor as shown in FIGS. 10 and 11 can
push the suture anchors down into soft tissue and bone to the same
level. However, insertion using an initial anchor impactor may only
put the anchors partially through soft tissue and bone. A final
impactor 120 may be needed to complete insertion of the suture
anchors and tensioning of the suture material, thus optimizing soft
tissue attachment to bone.
[0065] Referring now to FIGS. 12 and 13, a final impactor or
tensioner 120 having a single cannula is used to tension the suture
and fully impact each anchor into the bone. The final impactor is
cannulated so that it can be inserted along a guide wire to reach
the anchors. The final impactor 120 has an elongated tubular body
122. A region of the final impactor has a handle 125 that extends
perpendicular to the longitudinal axis of the tubular body 122. The
handle 125 can be on any side or both sides of the tubular body 122
and can be of any shape or size as long as force can be applied to
the handle to tap down an anchor into bone. The final impactor 120
has a region 130 adapted to operatively engage the top of an anchor
so as to permit downward force in direction D to be transmitted to
the anchor. Region 130 is approximately the same size as the top of
anchor 20. Final impactor 120 is utilized separately on each
anchor. It is preferable that anchors 20 are inserted into the bone
so that the top of anchor 20 is approximately 5-6 millimeters into
the bone. At this point, suture 30 will be taut locking soft tissue
70 adjacent to bone 60. Like an initial anchor impactor, a final
impactor can be made of 316 L stainless steel or similar strength
alloy.
[0066] Complete seating of the anchors in the bone can be done by
alternating the single final impactor over each guide wire and
slightly tapping each anchor into place. Complete seating of the
anchor suture forms vertical anchor fixations as well as a
horizontal mattress suture. With the impactor in place, the guide
wire can then be removed with pliers or a drill. The same technique
can be repeated to remove the rest of guide wires.
[0067] Other instruments can also be adapted for use with the
multi-anchor suture assembly of the invention. One such alternative
is a gun pre-loaded with the anchor suture assemblies. A gun can be
used to deliver non-cannulated anchor suture as well as cannulated
suture assemblies. Guns for delivery of non-cannulated anchors have
been described previously by Surgical Dynamics of Norwalk,
Conn.
[0068] A gun may also be cannulated to fire cannulated multi-anchor
suture assemblies into soft tissue and bone. A gun having
cannulated holes can be pre-loaded with cannulated anchor
assemblies. The gun can then be fit over guide wires for exact
placement of the anchor assemblies. The anchor assemblies can then
be fired with sufficient velocity to penetrate soft tissue and
bone. Using a gun to deliver a multi-anchor suture may eliminate
the need for pre-drilling holes and avoid the use of additional
instrumentation. Anchor insertion with guns may be significantly
faster where multiple insertions are necessary.
[0069] Depending on the surgical situation, a single or multiple
anchor suture assemblies may be needed to accomplish proper repairs
of soft tissue to bone connection. As is well within the skill in
the art to recognize and perform, and depending upon the type and
severity of the soft tissue to bone attachment that is required,
more than one device of the invention may be used in concert. For
example, multiple dual-anchor sutures may be required. FIG. 14
illustrates a cross-sectional view of soft tissue-bone attachment
using more than one dual-anchor suture. As one integrated assembly,
the suture anchor 10 is inserted through soft tissue and bone. The
multiple anchors of one suture assembly provide multiple points of
vertical fixation. In addition, the suture assembly provides
horizontal tension to strengthen soft tissue to bone attachment.
Each anchor may be separated by distances such as at least 5 mm to
leave some bony bridge between the anchors. For multiple suture
assemblies, the anchors may be staggered from the edge of the
tuberosity toward the joint by distances including 5 mm. Multiple
insertions of the anchor suture assemblies expand the area for soft
tissue to bone repair.
[0070] It would be within the skill in the art based upon this
disclosure to use any combination of the multiple anchor sutures of
the invention during the same operation to allow ideal apposition
of the entire avulsed soft tissue structure to bone.
[0071] The present invention is not to be limited in scope by the
specific embodiments described herein. Modifications thereof will
become apparent to those in the art based on the teachings of the
foregoing description and drawings. Such modifications fall within
the scope of the claimed invention.
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