U.S. patent application number 10/885282 was filed with the patent office on 2005-02-10 for bone anchor insertion device.
This patent application is currently assigned to Opus Medical, Inc.. Invention is credited to Foerster, Seth, Gregoire, David, Tran, Minh, White, George.
Application Number | 20050033364 10/885282 |
Document ID | / |
Family ID | 26759418 |
Filed Date | 2005-02-10 |
United States Patent
Application |
20050033364 |
Kind Code |
A1 |
Gregoire, David ; et
al. |
February 10, 2005 |
Bone anchor insertion device
Abstract
A bone anchor insertion device comprises a handle, a nosepiece
connected to a distal end of the handle, a bone anchor connected to
the nosepiece, and an actuator disposed on the handle for deploying
the bone anchor, which suture is also fixed to a portion of soft
tissue to be attached to a portion of bone. A suture ratchet or
tensioning mechanism is disposed in the handle for tensioning
suture which is associated with the bone anchor. This mechanism
permits precise tensioning, while also permitting one-handed
operation, thereby allowing the practitioner to use his or her
other hand for other activities, such as camera operation or the
like.
Inventors: |
Gregoire, David; (Laguna
Niguel, CA) ; White, George; (Corona, CA) ;
Tran, Minh; (Fountain Valley, CA) ; Foerster,
Seth; (San Clemente, CA) |
Correspondence
Address: |
Donald E. Stout
Stout, Uxa, Buyan & Mullins, LLP
Suite 300
4 Venture
Irvine
CA
92618
US
|
Assignee: |
Opus Medical, Inc.
San Juan Capistrano
CA
|
Family ID: |
26759418 |
Appl. No.: |
10/885282 |
Filed: |
July 6, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10885282 |
Jul 6, 2004 |
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10077574 |
Feb 15, 2002 |
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6780198 |
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60338429 |
Dec 6, 2001 |
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Current U.S.
Class: |
606/232 |
Current CPC
Class: |
A61B 2017/0496 20130101;
A61B 17/0401 20130101; A61B 2017/0435 20130101; A61B 2017/045
20130101; A61B 2017/0409 20130101 |
Class at
Publication: |
606/232 |
International
Class: |
A61B 017/04 |
Claims
1. A bone anchor insertion device, comprising: a handle; a
nosepiece connected to a distal end of said handle; a bone anchor
connected to said nosepiece; an actuator disposed on said handle
for deploying said bone anchor; and a suture tensioning mechanism
disposed in said handle for tensioning suture which is associated
with said bone anchor.
2. (Canceled)
3. (Canceled)
4. The bone anchor insertion device as recited in claim 1, wherein
said suture is fixed to a portion of soft tissue to be attached to
a portion of bone.
5. The bone anchor insertion device as recited in claim 1, wherein
said bone anchor comprises a tubular body which is adapted to
received said suture therethrough.
6-14. (Canceled)
15. A method for making an orthopedic repair, by re-attaching a
portion of soft tissue to a portion of adjacent bone, using a bone
anchor insertion device comprising a handle and a nosepiece
attached to a distal end of said handle, said method comprising: a)
passing a length of suture through said portion of soft tissue so
that a loop of suture is embedded therein; b) passing a free end of
said length of suture through said nosepiece, a bone anchor
disposed thereon, and said handle; and c) securing said free end of
said length of suture to a suture tensioning mechanism in said
handle.
16. The method as recited in claim 15, said method further
comprising: d) locating said bone anchor so that it lies beneath a
cortical bone surface of said portion of adjacent bone; e)
deploying said bone anchor so that it remains in place beneath said
cortical bone surface; and f) actuating said suture tensioning
mechanism to tension said length of suture, thereby approximating
said soft tissue portion to said adjacent bone portion as
desired.
17. The method as recited in claim 16, wherein said bone anchor
insertion device further comprises a pull tube disposed in said
nosepiece, and an actuator on said handle for moving said pull tube
proximally a desired distance, said bone anchor deployment step
further comprising actuating said handle actuator to move said pull
tube proximally, until a laterally deployable portion of said bone
anchor abuts a mandrel surface on said nosepiece and is thereby
forced to laterally deploy.
18. The method as recited in claim 17, wherein, subsequent to said
bone anchor deployment step a connection between said bone anchor
and said pull tube fractures upon continued proximal movement of
said pull tube.
19. The method as recited in claim 18, said bone anchor insertion
device further comprising a suture plug attached to a distal end of
said pull tube for immobilizing suture within said bone anchor,
said method further comprising: g) continuing to actuate said
handle actuator, to thereby move said pull tube proximally, to
thereby move said suture plug proximally to immobilize suture
within said bone anchor.
20. The method as recited in claim 19, and further comprising: h)
separating said bone anchor insertion device from said bone anchor
and suture plug; i) withdrawing said bone anchor insertion device
from the repair site; and j) trimming off said suture to complete
the repair.
21. The method as recited in claim 20, and further comprising
repeating steps a) through j) to create another attachment between
said portion of soft tissue and said adjacent bone.
22. The method as recited in claim 15, wherein step b) comprises
passing two free ends of said suture through said nosepiece, a bone
anchor disposed therein, and said handle.
23. A method for making an orthopedic repair, by re-attaching a
portion of soft tissue to a portion of adjacent bone, using a bone
anchor insertion device comprising a handle and a nosepiece
attached to a distal end of said handle, said method comprising: a)
passing a length of suture through said portion of soft tissue so
that a loop of suture is embedded therein; b) inserting a pull
tube, on which is disposed a bone anchor having a laterally
deployable member, into said nosepiece; c) passing at least one
free end of said length of suture through said nosepiece, said bone
anchor, and said handle, using snares; d) locating said bone anchor
so that it lies beneath a cortical bone surface of said portion of
adjacent bone; and e) actuating an actuator on said handle to move
said pull tube proximally, until said bone anchor is engaged with a
mandrel surface on said nosepiece and said laterally deployable
member is forced to deploy.
24. The method as recited in claim 23, and further comprising: f)
tensioning said length of suture to approximate said portion of
soft tissue to said adjacent portion of bone, as desired.
25. The method as recited in claim 24, and further comprising: g)
continuing to actuate said actuator on said handle to further move
said pull tube proximally, to thereby move a suture plug attached
to a distal end of said pull tube proximally to engage and
immobilize suture disposed in said bone anchor.
26. The method as recited in claim 25, and further comprising: h)
separating said bone anchor insertion device from said bone anchor
and suture plug; i) withdrawing said bone anchor insertion device
from the repair site; and j) trimming off said suture to complete
the repair.
27. The method as recited in claim 26, and further comprising
repeating steps a) through j) to create another attachment between
said portion of soft tissue and said adjacent bone.
28. A bone anchor insertion device, comprising: a handle; a first
snare for receiving a suture loop; and a second snare for receiving
the suture loop from said first snare.
29. The bone anchor insertion device as recited in claim 28,
wherein said first snare is relatively short and said second snare
is relatively long.
30. The bone anchor insertion device as recited in claim 28,
wherein said device further comprises a nosepiece disposed distally
of said handle and a bone anchor connected to said nosepiece, said
second snare extending through said nosepiece, handle, and anchor
and being removable from said device from a proximal end
thereof.
31. A method for making an orthopedic repair, by re-attaching a
portion of soft tissue to a portion of adjacent bone, using a bone
anchor insertion device comprising a first snare having a first
loop and a second snare having a second loop, said method
comprising: a) threading a free end of a length of suture which
extends from said portion of soft tissue through the first loop of
said first snare; and b) pulling said first snare distally to
thereby draw said length of suture through the second loop of said
second snare.
32. The method as recited in claim 31, and further comprising a
step of pulling said second snare proximally from said device,
thereby threading said suture loop through said device.
Description
[0001] This application claims the benefit, under 35 U.S.C. 119(e),
of the filing date of Provisional Patent Application Ser. No.
60/338,429, filed on Dec. 6, 2001.
BACKGROUND OF THE INVENTION
[0002] This invention relates generally to methods and apparatus
for attaching soft tissue to bone, and more particularly to anchors
and methods for securing connective tissue, such as ligaments or
tendons, to bone. The invention has particular application to
arthroscopic surgical techniques for reattaching the rotator cuff
to the humeral head, in order to repair the rotator cuff.
[0003] It is an increasingly common problem for tendons and other
soft, connective tissues to tear or to detach from associated bone.
One such type of tear or detachment is a "rotator cuff" tear,
wherein the supraspinatus tendon separates from the humerus,
causing pain and loss of ability to elevate and externally rotate
the arm. Complete separation can occur if the shoulder is subjected
to gross trauma, but typically, the tear begins as a small lesion,
especially in older patients.
[0004] To repair a torn rotator cuff, the typical course today is
to do so surgically, through a large incision. This approach is
presently taken in almost 99% of rotator cuff repair cases. There
are two types of open surgical approaches for repair of the rotator
cuff, one known as the "classic open" and the other as the
"mini-open". The classic open approach requires a large incision
and complete detachment of the deltoid muscle from the acromion to
facilitate exposure. The cuff is debrided to ensure suture
attachment to viable tissue and to create a reasonable edge
approximation. In addition, the humeral head is abraded or notched
at the proposed soft tissue to bone reattachment point, as healing
is enhanced on a raw bone surface. A series of small diameter
holes, referred to as "transosseous tunnels", are "punched" through
the bone laterally from the abraded or notched surface to a point
on the outside surface of the greater tuberosity, commonly a
distance of 2 to 3 cm. Finally, the cuff is sutured and secured to
the bone by pulling the suture ends through the transosseous
tunnels and tying them together using the bone between two
successive tunnels as a bridge, after which the deltoid muscle must
be surgically reattached to the acromion. Because of this maneuver,
the deltoid requires postoperative protection, thus retarding
rehabilitation and possibly resulting in residual weakness.
Complete rehabilitation takes approximately 9 to 12 months.
[0005] The mini-open technique, which represents the current
growing trend and the majority of all surgical repair procedures,
differs from the classic approach by gaining access through a
smaller incision and splitting rather than detaching the deltoid.
Additionally, this procedure is typically performed in conjunction
with arthroscopic acromial decompression. Once the deltoid is
split, it is retracted to expose the rotator cuff tear. As before,
the cuff is debrided, the humeral head is abraded, and the
so-called "transosseous tunnels", are "punched" through the bone or
suture anchors are inserted. Following the suturing of the rotator
cuff to the humeral head, the split deltoid is surgically
repaired.
[0006] Although the above described surgical techniques are the
current standard of care for rotator cuff repair, they are
associated with a great deal of patient discomfort and a lengthy
recovery time, ranging from at least four months to one year or
more. It is the above described manipulation of the deltoid muscle
together with the large skin incision that causes the majority of
patient discomfort and an increased recovery time.
[0007] Less invasive arthroscopic techniques are beginning to be
developed in an effort to address the shortcomings of open surgical
repair. Working through small trocar portals that minimize
disruption of the deltoid muscle, a few surgeons have been able to
reattach the rotator cuff using various bone anchor and suture
configurations. The rotator cuff is sutured intracorporeally and an
anchor is driven into bone at a location appropriate for repair.
Rather than thread the suture through transosseous tunnels which
are difficult or impossible to create arthroscopically using
current techniques, the repair is completed by tying the cuff down
against bone using the anchor and suture. Early results of less
invasive techniques are encouraging, with a substantial reduction
in both patient recovery time and discomfort.
[0008] Unfortunately, the skill level required to facilitate an
entirely arthroscopic repair of the rotator cuff is inordinately
high. Intracorporeal suturing is clumsy and time consuming, and
only the simplest stitch patterns can be utilized. Extracorporeal
knot tying is somewhat less difficult, but the tightness of the
knots is difficult to judge, and the tension cannot later be
adjusted. Also, because of the use of bone anchors to provide a
suture fixation point in the bone, the knots that secure the soft
tissues to the anchor by necessity leave the knot bundle on top of
the soft tissues. In the case of rotator cuff repair, this means
that the knot bundle is left in the shoulder capsule where it can
be felt by the patient postoperatively when the patient exercises
the shoulder joint. So, knots tied arthroscopically are difficult
to achieve, impossible to adjust, and are located in less than
optimal areas of the shoulder. Suture tension is also impossible to
measure and adjust once the knot has been fixed. Consequently,
because of the technical difficulty of the procedure, presently
less than 1% of all rotator cuff procedures is of the arthroscopic
type, and is considered investigational in nature.
[0009] Another significant difficulty with current arthroscopic
rotator cuff repair techniques is shortcomings related to currently
available suture anchors. Suture eyelets in bone anchors available
today, which like the eye of a needle are threaded with the thread
or suture, are small in radius, and can cause the suture to fail at
the eyelet when the anchor is placed under high tensile loads.
[0010] There are various bone anchor designs available for use by
an orthopedic surgeon for attachment of soft tissues to bone. The
basic commonality between the designs is that they create an
attachment point in the bone for a suture that may then be passed
through the soft tissues and tied, thereby immobilizing the soft
tissue. This attachment point may be accomplished by different
means. Screws are known for creating such attachments, but existing
designs suffer from a number of disadvantages, including their
tendency to loosen over time, requiring a second procedure to later
remove them, and their requirement for a relatively flat attachment
geometry.
[0011] Another approach is to utilize the difference in density in
the cortical bone (the tough, dense outer layer of bone) and the
cancellous bone (the less dense, airy and somewhat vascular
interior of the bone). There is a clear demarcation between the
cortical bone and cancellous bone, where the cortical bone presents
a kind of hard shell over the less dense cancellous bone. The
aspect ratio of the anchor is such that it typically has a longer
axis and a shorter axis and usually is pre-threaded with a suture.
These designs use a hole in the cortical bone through which an
anchor is inserted. The hole is drilled such that the shorter axis
of the anchor will fit through the diameter of the hole, with the
longer axis of the anchor being parallel to the axis of the drilled
hole. After deployment in to the cancellous bone, the anchor is
rotated 90.sup.B so that the long axis is aligned perpendicularly
to the axis of the hole. The suture is pulled, and the anchor is
seated up against the inside surface of the cortical layer of bone.
Due to the mismatch in the dimensions of the long axis of the
anchor and the hole diameter, the anchor cannot be retracted
proximally from the hole, thus providing resistance to pull-out.
These anchors still suffer from the aforementioned problem of
eyelet design that stresses the sutures.
[0012] Still other prior art approaches have attempted to use a
"pop rivet" approach. This type of design requires a hole in the
cortical bone into which a split shaft is inserted. The split shaft
is hollow, and has a tapered plug leading into its inner lumen. The
tapered plug is extended out through the top of the shaft, and when
the plug is retracted into the inner lumen, the tapered portion
causes the split shaft to be flared outwardly, ostensibly locking
the device into the bone.
[0013] Other methods of securing soft tissue to bone are known in
the prior art, but are not presently considered to be feasible for
shoulder repair procedures, because of physicians' reluctance to
leave anything but a suture in the capsule area of the shoulder.
The reason for this is that staples, tacks, and the like could
possibly fall out and cause injury during movement. As a result of
this constraint, the attachment point often must be located at a
less than ideal position. Also, the tacks or staples require a
substantial hole in the soft tissue, and make it difficult for the
surgeon to precisely locate the soft tissue relative to the
bone.
[0014] As previously discussed, any of the anchor points for
sutures mentioned above require that a length of suture be passed
through an eyelet fashioned in the anchor and then looped through
the soft tissues and tied down to complete the securement. Much
skill is required, however, to both place the sutures in the soft
tissues, and to tie knots while working through a trocar under
endoscopic visualization.
[0015] There have been attempts to solve some of the problems that
exist in current anchor designs. One such approach is disclosed in
U.S. Pat. No. 5,324,308 to Pierce. In this patent, there is
disclosed a suture anchor that incorporates a proximal and distal
wedge component having inclined mating faces. The distal wedge
component has two suture thread holes at its base through which a
length of suture may be threaded. The assembly may be placed in a
drilled hole in the bone, and when tension is placed on the suture,
the distal wedge block is caused to ride up against the proximal
wedge block, expanding the projected area within the drilled hole,
and locking the anchor into the bone. This approach is a useful
method for creating an anchor point for the suture, but does not in
any way address the problem of tying knots in the suture to fix the
soft tissue to the bone.
[0016] The problem of placing sutures in soft tissues and tying
knots in an endoscopic environment is well known, and there have
been attempts to address the problem and to simplify the process of
suture fixation. One such approach is disclosed in U.S. Pat. No.
5,383,905 to Golds et al. The patent describes a device for
securing a suture loop about bodily tissue that includes a bead
member having a longitudinal bore and an anchor member adapted to
be slidably inserted within the bore of the bead member. The anchor
member includes at least two axial compressible sections which
define a passageway to receive two end portions of a suture loop.
The axial sections collapse radially inwardly upon insertion of the
anchor member within the bore of the bead member to securely wedge
the suture end portions received within the passageway.
[0017] Although the Golds et al. patent approach utilizes a
wedge-shaped member to lock the sutures in place, the suture legs
are passing through the bore of the bead only one time, in a
proximal to distal direction, and are locked by the collapsing of
the wedge, which creates an interference on the longitudinal bore
of the anchor member. Also, no provision is made in this design for
attachment of sutures to bone. The design is primarily suited for
locking a suture loop, such as is used for ligation or
approximation of soft tissues.
[0018] A prior art approach that includes tissue attachment is
described in U.S. Pat. No. 5,405,359 to Pierce. In this system, a
toggle wedge is comprised of a two piece structure comprising a top
portion characterized by the presence of a barbed tip and a bottom
portion. The suturing material extends through apertures in each of
the two toggle portions, and is maintained in position by means of
a knot disposed in the suture at a lower edge of the bottom toggle
portion. To anchor the suture into adjacent soft tissue, the two
toggle portions are rotated relative to one another, as shown for
example in FIG. 33. The disclosure states that the device could be
used to anchor suture in bone, as well as soft tissue, if two
embodiments are utilized in tandem. However, the system is
disadvantageous in that it is complex, difficult to manipulate, and
still requires the tying of a knot in the suture.
[0019] Another approach that includes bone attachment is described
in U.S. Pat. No. 5,584,835 to Greenfield. In this patent, a two
part device for attaching soft tissue to bone is shown. A bone
anchor portion is screwed into a hole in the bone, and is disposed
to accept a plug that has been adapted to receive sutures. In one
embodiment, the suture plug is configured so that when it is forced
into its receptacle in the bone anchor portion, sutures that have
been passed through an eyelet in the plug are trapped by friction
between the wall of the anchor portion and the body of the plug
portion.
[0020] Although there is some merit to this approach for
eliminating the need for knots in the attachment of sutures to
bone, a problem with being able to properly set the tension in the
sutures exists. The user is required to pull on the sutures until
appropriate tension is achieved, and then to set the plug portion
into the bone anchor portion. This action increases the tension in
the sutures, and may garrot the soft tissues or increase the
tension in the sutures beyond the tensile strength of the material,
breaking the sutures. In addition, the minimal surface area
provided by this anchor design for pinching or locking the sutures
in place will abrade or damage the suture such that the suture's
ability to resist load will be greatly compromised.
[0021] A disclosure that incorporates bone attachment and
eliminates knot tying is set forth in U.S. Pat. No. 5,702,397 to
Goble et al. One embodiment, in particular, is shown in FIG. 23 of
that patent and includes a bone anchor that has a threaded body
with an inner cavity. The cavity is open to one end of the threaded
body, and joins two lumens that run out to the other end of the
threaded body. Within the cavity is disposed a gear, journaled on
an axle. A length of suture is threaded through one lumen, around
the gear, and out through the other lumen. A ball is disposed
within the cavity to ride against a tapered race and ostensibly
lock the suture in place. What is not clear from the patent
disclosure is how the force D shown as the tension in the suture
would lock the ball into the race. Although this embodiment
purports to be a self-locking anchor adapted for use in blind holes
for fixing sutures into bone, the construct shown is complicated,
and does not appear to be adequate to reliably fixate the
suture.
[0022] U.S. Pat. No. 5,782,863 to Bartlett discloses a suture
anchor including bone attachment, which simply comprises a conical
suture anchor having an anchor bore through which a length of
suture is threaded. The anchor is inserted into a bore within a
portion of bone using an insertion tool having a shape memory
insertion end. As the anchor is inserted, because of its conical
shape, it will re-orient itself by rotating in order to fit into
the bore, bending the end of the insertion tool. However, once the
proximal edge of the bone anchor enters cancellous bone, the shape
memory insertion end of the insertion tool will begin resuming its
natural straight orientation, thus rotating the anchor back into
its original orientation. The corners of the conical body thus
protrude into the soft cancellous bone, and the anchor body is
prevented from exiting proximally from the bone bore through the
hard cortical bone. The insertion tool is then removed.
[0023] The Bartlett patent approach, while innovative, is
disadvantageous to the extent that it involves the use of a unique
and complex insertion tool, and can be difficult to deploy. It also
does not permit suturing of the soft tissue prior to anchoring the
suture to bone, and thus does not permit tensioning of the suture
to approximate the soft tissue to bone, as desired, at the
conclusion of the suturing procedure. Additionally, in preferred
embodiments, the suture is knotted to the anchor, a known
disadvantage.
[0024] Yet another prior art approach is disclosed in U.S. Pat. No.
5,961,538 to Pedlick et al. In this patent, a wedge shaped suture
anchor system is described for anchoring a length of suture within
a bore in a bone portion, which comprises an anchor body having an
offset suture opening for receiving the length of suture
therethrough, and for creating an imbalance in the rotation of the
device as it is inserted. A shaft portion is utilized to insert the
wedge-shaped anchor body into the bone bore. Once the anchor body
is in cancellous bone, below the cortical bone layer, the shaft is
pulled proximally to cause the anchor body to rotate, thereby
engaging the corners of the anchor body with the cancellous bone.
The shaft then becomes separated from the anchor body, leaving the
anchor body in place within the bone.
[0025] The Pedlick et al. approach is conventional, in that the
suture is attached to desired soft tissue after it is anchored
within the bone. Consequently, there is no opportunity to tension
the suture, as desired, to optimally approximate the soft tissue to
the bone upon completion of the surgical procedure. Additionally,
the approach is complex and limited in flexibility, since the
suture is directly engaged with the bone anchoring body. There is
also the possibility that the bone anchoring body will not
sufficiently rotate to firmly become engaged with the cancellous
bone before the insertion tool breaks away from the anchor body, in
which case it will be impossible to properly anchor the suture.
[0026] U.S. Pat. No. 6,056,773 to Bonutti discloses a suture
anchoring system which is somewhat similar to that disclosed by
Pedlick et al. A cylindrical suture anchor body is provided which
is insertable into a bone bore, using a pusher member which pushes
distally on the anchor body from a proximal direction. As the
anchor body proceeds into the bone bore, below the cortical bone
surface, the suture extending through the lumen of the anchor body
applies a proximal tensile force on the anchor body, to cause the
anchor body to rotate relative to the pusher member, thereby
anchoring the anchor body in cancellous bone. Of course, this
system has similar disadvantages to those of the Pedlick et al.
system, and requires the suture to be directly engaged with the
bone anchoring body.
[0027] What is needed, therefore, is a new approach for repairing
the rotator cuff or fixing other soft tissues to bone, wherein both
the bone and suture anchors reside completely below the cortical
bone surface, there is no requirement for the surgeon to tie a knot
to attach the suture to the bone anchor, and wherein suture tension
can be adjusted and possibly measured. The procedure associated
with the new approach should better for the patient than existing
procedures, should save time, be uncomplicated to use, and be
easily taught to practitioners having skill in the art.
SUMMARY OF THE INVENTION
[0028] The present invention solves the problems outlined above by
providing innovative bone anchor and connective techniques which
permit a suture attachment which lies entirely beneath the cortical
bone surface, and which further permit the attachment of suture to
the bone anchor without the necessity for tying knots, which is
particularly arduous and technically demanding in the case of
arthroscopic procedures. In particular, the present invention
employs a uniquely advantageous handle actuator which facilitates a
convenient and efficient procedure for the medical
practitioner.
[0029] More particularly, there is provided a bone anchor insertion
device, comprising a handle, a nosepiece connected to a distal end
of the handle, a bone anchor connected to the nosepiece, and an
actuator disposed on the handle for deploying the bone anchor,
which suture is also fixed to a portion of soft tissue to be
attached to a portion of bone. Advantageously, a suture ratchet or
tensioning mechanism is disposed in the handle for tensioning
suture which is associated with the bone anchor. This mechanism
permits precise tensioning, while also permitting one-handed
operation, thereby allowing the practitioner to use his or her
other hand for other activities, such as camera operation or the
like.
[0030] In a preferred embodiment, the suture tensioning mechanism
comprises a suture knob and a suture ratchet wheel, wherein the
suture knob is rotatable to rotate the suture ratchet wheel. The
suture ratchet wheel includes a suture fixation slit disposed
therein for receiving a free end of the suture. The bone anchor
comprises a tubular body which is adapted to received the suture
therethrough.
[0031] In another aspect of the invention, there is provided a bone
anchor insertion device, comprising a handle, and a nosepiece
connected to a distal end of the handle, wherein the nosepiece
comprises an outer tube having a suture opening formed in its
distal end and an inner tube disposed coaxially within the outer
tube. The inner tube includes a longitudinal slot or opening
therein, and is fixed relative to the outer tube. A pull tube is
provided, which is insertable into the inner tube. A bone anchor is
disposed on the pull tube, which includes a laterally deployable
member for engaging adjacent bone matter to secure the bone anchor
in the bone matter. The inventive device further comprises an
actuator disposed on the handle for pulling the pull tube
proximally to deploy the laterally deployable member of the bone
anchor by engaging the laterally deployable member with a distal
end surface of the inner tube. Preferably, the laterally deployable
member comprises a toggle ring member.
[0032] In preferred embodiments, the inventive bone anchor
insertion device further comprises a suture immobilizing member
which is associated with the bone anchor for immobilizing a length
of suture situated within the bone anchor. The suture immobilizing
member, preferably a suture plug, is connected to a distal end of
the pull tube, so that further actuation of the actuator on the
handle after deployment of the laterally deployable member of the
bone anchor causes the suture immobilizing member to move
proximally to engage and immobilize the length of suture. A tab is
disposed at a distal end of the pull tube for attaching the bone
anchor to the pull tube, which tab is designed to break upon
continued proximal movement of the pull tube once the laterally
deployable member has been completely deployed, so that further
proximal movement of the pull tube causes the suture immobilizing
member to move proximally.
[0033] In still another aspect of the invention, a method for
making an orthopedic repair, by re-attaching a portion of soft
tissue to a portion of adjacent bone, using a bone anchor insertion
device comprising a handle and a nosepiece attached to a distal end
of said handle, is described. This method comprises steps of:
[0034] a) passing a length of suture through the portion of soft
tissue so that a loop of suture is embedded therein;
[0035] b) passing a free end of the length of suture through the
nosepiece, a bone anchor disposed thereon, and the handle; and
[0036] c) securing the free end of the length of suture to a suture
tensioning mechanism in the handle. Further inventive steps
include:
[0037] d) locating the bone anchor so that it lies beneath a
cortical bone surface of the portion of adjacent bone, preferably
by moving the bone insertion device into the vicinity of the repair
site through a trocar or the like;
[0038] e) deploying the bone anchor so that it remains in place
beneath the cortical bone surface; and
[0039] f) actuating the suture tensioning mechanism to tension the
length of suture, thereby approximating the soft tissue portion to
the adjacent bone portion as desired.
[0040] In a preferred method, the bone anchor insertion device
further comprises a pull tube disposed in the nosepiece, and an
actuator on the handle for moving the pull tube proximally a
desired distance. The bone anchor deployment step further comprises
actuating the handle actuator to move the pull tube proximally,
until a laterally deployable portion of the bone anchor abuts a
mandrel surface on the nosepiece and is thereby forced to laterally
deploy. Subsequent to the bone anchor deployment step, a connection
between the bone anchor and the pull tube fractures upon continued
proximal movement of the pull tube.
[0041] Preferably, the bone anchor insertion device further
comprises a suture plug attached to a distal end of the pull tube
for immobilizing suture within the bone anchor. Thus, the inventive
method further comprises a step of continuing to actuate the handle
actuator, to thereby move the pull tube proximally, to thereby move
the suture plug proximally to immobilize suture within the bone
anchor. Then, to complete the procedure, the bone anchor insertion
device is separated from the bone anchor and suture plug, the bone
anchor insertion device is withdrawn from the repair site, and the
suture is trimmed off to complete the repair. The entire method may
then be repeated as many times as desired in order to create
additional attachment points between the portion of soft tissue and
the bone portion, in order to improve the integrity of the effected
repair.
[0042] In yet another aspect of the invention, there is described a
method for making an orthopedic repair, by re-attaching a portion
of soft tissue to a portion of adjacent bone, using a bone anchor
insertion device comprising a handle and a nosepiece attached to a
distal end of said handle. This method comprises the steps of:
[0043] a) passing a length of suture through the portion of soft
tissue so that a loop of suture is embedded therein;
[0044] b) inserting a pull tube, on which is disposed a bone anchor
having a laterally deployable member, into the nosepiece;
[0045] c) passing a free end of the length of suture through the
nosepiece, the bone anchor, and the handle, using snares;
[0046] d) locating the bone anchor so that it lies beneath a
cortical bone surface of the portion of adjacent bone; and
[0047] e) actuating an actuator on the handle to move the pull tube
proximally, until the bone anchor is engaged with a mandrel surface
on the nosepiece and the laterally deployable member is forced to
deploy. In preferred approaches, the method further comprises steps
of:
[0048] f) tensioning the length of suture to approximate the
portion of soft tissue to the adjacent portion of bone, as
desired;
[0049] g) continuing to actuate the actuator on the handle to
further move the pull tube proximally, to thereby move a suture
plug attached to a distal end of the pull tube proximally to engage
and immobilize suture disposed in the bone anchor;
[0050] h) separating the bone anchor insertion device from the bone
anchor and suture plug;
[0051] i) withdrawing the bone anchor insertion device from the
repair site; and
[0052] j) trimming off the suture to complete the repair.
[0053] The invention, together with additional features and
advantages thereof, may best be understood by reference to the
following description taken in conjunction with the accompanying
illustrative drawing.
BRIEF DESCRIPTION OF THE DRAWINGS
[0054] FIG. 1 is a perspective view of a preferred embodiment of
the inserter portion of a bone anchor device constructed in
accordance with the principles of the present invention;
[0055] FIG. 2 is a perspective view of a bone anchor device of the
present invention, including a bone anchor portion and the inserter
portion illustrated in FIG. 1;
[0056] FIG. 3 is a plan view of the handle of the device
illustrated in FIGS. 1 and 2;
[0057] FIG. 3A is partial perspective view of the handle
illustrated in FIG. 3, with the suture support lever in a first
position;
[0058] FIG. 3B is a perspective view of the handle illustrated in
FIGS. 3 and 3A, with the suture support lever in a second
position;
[0059] FIG. 4A is a perspective view of the anchor portion of the
bone anchor device of the invention, showing the anchor deployment
portion of the bone anchor device wherein the short snare has been
threaded by a suture loop which is stitched through a piece of soft
tissue to be repaired;
[0060] FIG. 4B is a perspective view similar to FIG. 4A,
illustrating the next step in the preferred method, wherein the
short snare has been removed distally to thread the long snare
loop;
[0061] FIG. 4C is a perspective view of the bone anchor device of
the invention, illustrating the step of removing the long snare
loop proximally through the device to tension the suture loop;
[0062] FIG. 4D is a perspective view of the suture mechanism of the
inventive device;
[0063] FIGS. 5A-5G are plan schematic views showing the sequential
operation of the suture mechanism of the inventive device in a
preferred method for using the device;
[0064] FIGS. 6A-6D are perspective views in sequence showing steps
in a preferred method of using the inventive bone anchor device to
secure soft tissue to adjacent bone;
[0065] FIGS. 7A-7B are cross-sectional views in sequence showing
further steps in the preferred method of using the inventive bone
anchor device to secure soft tissue to adjacent bone;
[0066] FIGS. 8A-8B are cross-sectional views in sequence showing
still further steps in the preferred method illustrated in FIGS.
6A-7B; and
[0067] FIG. 8C is an end view illustrating a step of trimming the
excess suture at the conclusion of the method shown in FIGS.
6A-8B.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0068] Referring now more particularly to the drawings, there is
shown in FIG. 1 a bone anchor insertion device 10, constructed in
accordance with one embodiment of the present invention. The bone
anchor insertion device 10 is comprised of an inserter handle 12
and an inserter nosepiece 14, which is attached to a distal end of
the handle portion 12. The inserter handle 12 comprises a handle
housing 16 which is constructed of a rigid material, such as
plastic or metal. The housing is shaped and configured to
accommodate a plurality of mechanical components for effecting
insertion of a bone anchor during an orthopedic repair procedure,
such as the re-attachment of a portion of soft tissue to adjacent
bone. Such a procedure may preferably involve a rotator cuff repair
procedure.
[0069] More particularly, the aforementioned plurality of
mechanical components include, in a preferred embodiment, a suture
knob 18, which is rotatably attached to a suture ratchet wheel 20,
a hand lever 22 pivotally attached to the housing 16 by means of a
pivot pin 24, and an anchor load lever 26. Referring additionally
to FIG. 2, it can be seen that the housing 16 also includes a
function lever 28. These components will be more particularly
described below in conjunction with an explanation of a preferred
method for using the bone anchor insertion device 10, and are
typically fabricated of a variety of materials, such as plastic,
aluminum, or stainless steel.
[0070] With reference still to FIGS. 1 and 2, the inserter
nosepiece 14 comprises an outer tube 30 having a suture opening 32
formed in its distal end, as shown in FIG. 1. An inner slotted tube
34 is disposed coaxially within the outer tube 30, which, as noted,
includes a longitudinal slot or opening 36. The inner tube 34 is
preferably fixed relative to the outer tube 30, such that the inner
tube 34 is not axially slidable or rotatable relative to the outer
tube 30. As will be explained further hereinbelow, the primary
function of the inner tube is to act as a mandrel or stop for the
purpose of engaging and deploying the bone anchor during the
insertion procedure, and the inner tube 34 may be referred to as a
die tube for this reason.
[0071] As shown in FIG. 2, a pull tube 38 is insertable, in coaxial
relationship, into the distal end of the inner slotted tube 34.
This pull tube 38, for purposes of illustration, is shown in FIG. 2
separate from the remainder of the device 10, and also in its
operable position, inserted from the distal end into the tube 34.
When inserted into the tube 34, most of the proximal portion of the
pull tube 38 is not visible, and is thus shown in phantom in FIG.
2.
[0072] The pull tube 38 is preferably constructed of stainless
steel, although other biocompatible materials may be employed as
well. A portion of the distal end of the pull tube 38 is
constructed such that part of the cylindrical sidewall is cut away,
to form a half-cylindrical shape, thereby forming a suture opening
40.
[0073] To the distal end of the pull tube 38 is affixed a bone
anchor 42 of the type disclosed and described in co-pending and
commonly assigned U.S. patent application Ser. No. 09/876,488,
entitled Method and Apparatus for Attaching Connective Tissues to
Bone Using a Knotless Suture Anchoring Device, herein expressly
incorporated by reference in its entirety. The bone anchor 42 is
best illustrated in FIGS. 6A-8C, and comprises a tubular or
cylindrical body 44, which may, for example, be a hypotube, in
which a series of diagonal cuts have been made at its proximal end
to create an annular generally elliptical angled toggle ring member
46. The cuts may be made by using wire Electro-Discharge Machining
(EDM) techniques, though many other suitable known methods and
materials for fabricating a generally tubular body and associated
proximal toggle ring member may be utilized as well. This toggle
ring member 46 is generally oriented diagonally relative to a
longitudinal axis 48 of the tubular anchor body 44 (FIG. 6B). The
toggle ring member 46 thus formed remains connected to the main
portion of the tubular body 44 by two thin struts 50 which are
situated such that they are substantially orthogonal to the
orientation of the toggle ring member 46, and disposed at an acute
angle relative to the longitudinal axis 48.
[0074] It is preferred that the anchor 10 be fabricated of
biocompatible materials such as 300-series stainless steel (Type
304 or Type 316, for example) or titanium, although suitable
bioresorbable plastics may potentially be used as well. In a
presently preferred embodiment, the anchor 42 is approximately 11
mm long and 2.8 mm in diameter.
[0075] The bone anchor 42 also includes elements comprising a
suture anchoring system. For example, as best shown in FIGS. 7A and
7B, a suture plug 52 is disposed at a distal end of the body 42,
and is attached at its proximal end to an actuation member 54,
which preferably comprises a relatively thin rod or shaft formed of
flat ribbon stock, and which extends proximally through the pull
tube 38. A pin member 56 is also disposed at the distal end of the
body 42, adjacent to the suture plug 52, as shown in FIGS. 7A and
7B, for functioning as a suture return member. This pin member 56
may be journaled or fixedly attached to the sidewall of the body
42, as is disclosed in co-pending application Ser. No. 09/876,488,
already incorporated by reference herein.
[0076] Now, with reference particularly to FIGS. 6A-8C, as well as
FIGS. 4A-4D and 5A-5G, a presently preferred bone and suture
anchoring method using the inventive device to reattach soft tissue
to bone will be described. As is described in co-pending
application Ser. No. 09/876,488, a preferred use for the inventive
apparatus is to repair a rotator cuff tendon injury, by reattaching
the soft tissue (tendon) 58 to the humerus bone 60. Of course, the
inventive apparatus may be used for many other types of orthopedic
repairs as well, but rotator cuff repair is representative, and
will be described herein.
[0077] With reference now to FIGS. 4A-4D and 6A-6D, in particular,
a generally tubular trocar (not shown) provides a conduit through
the soft tissue of the shoulder for the anchor device of the
present invention. Typically, the surgeon makes an incision or stab
wound through the outer dermal layers of sufficient size to permit
passage of the trocar through skin and the deltoid muscle into
proximity with the humeral head 60. Various trocars and techniques
for creating the approach passageway are known and may be utilized
with the present invention. In addition, more than one incision and
conduit may be necessary to perform the several suturing and
anchoring steps. Alternatively, some surgeons have been known to
dispense with the use of a trocar, and to directly insert
instruments through the stab wound and into the shoulder
capsule.
[0078] After establishing one or more direct conduits to the
humeral head 60, the surgeon passes a length of suture through the
soft tissue of the rotator cuff tendon 58 so that a loop 62 of
suture material is embedded therein, as seen in FIG. 6A. In
preferred approaches, the suture is attached to the soft tissue
using a "mattress stitch", which is well known in the art as being
a particularly secure stitch which is unlikely to fail
postoperatively. Preferably, a suturing instrument is inserted into
the trocar to perform the aforementioned suturing step. A preferred
suturing approach is taught in co-pending application Ser. No.
09/668,055, entitled Linear Suturing Apparatus And Methods, filed
on Sep. 21, 2000, expressly incorporated herein by reference and
commonly assigned herewith. Of course, the inventive devices may
also be utilized in an open surgical procedure, if desired, wherein
the sutures are manually placed.
[0079] Once the suturing process is completed, the free ends 33 of
the suture 28 are removed proximally through the trocar from the
patient's body, together with the suturing instrument The suture
loop 62, without the tissue 58, is shown in FIG. 4A for the purpose
of better illustrating the inventive anchoring method. The two free
ends 64a, 64b of the length of suture are withdrawn from the
patient and coupled to the suture anchor system in a manner to be
described.
[0080] More specifically, at this juncture the pull tube 38 is
inserted by the practitioner into the nosepiece 14. The anchor load
lever 26 is moved distally through a longitudinal slot or opening
66 in the housing 16, to thus move a rack mechanism 68 distally as
well, as shown in FIG. 5G. At this point, the three-position
function lever 28 is released by the practitioner. When released,
it returns to its center position or "suture lock" position, as
shown in FIG. 3. The pull tube 38 may then be inserted proximally
through the distal end of the slotted tube or mandrel 34, and into
the handle housing 16. The pull tube 38 is properly positioned when
the proximal end of the bone anchor 42 abuts the distal end of the
mandrel tube 34, as shown in FIGS. 2, 4A, and 6A. The anchor load
lever 26 is then rotated in a clockwise direction to tighten a
collet (not shown) within the housing 16. When the collet is
tightened, the pull tube 38 is longitudinally fixed relative to the
inserter nosepiece 14. A suture support lever 69 (FIGS. 1-3) is
then actuated to an upper position, as shown in FIG. 1, for
example, which causes the outer tube 30 to rotate relative to the
inner mandrel tube 34, thereby creating a guiding path for the
suture threaded through the device 10 relative to the device. More
particularly, this change in position of the suture support lever
69 causes a projecting portion 69a (FIG. 1) of the outer tube 30 to
rotate circumferentially to an orientation wherein it lies across
the longitudinal slot 36, for the purpose of segregating the suture
proximally from the anchor 42, to thereby avoid abrasion of the
suture on sharp anchor edges, and to alleviate sharp suture bends
in order to ease the process of tensioning the suture, as will be
described in greater detail below.
[0081] With the device outside of the patient's body, the
practitioner now threads the free ends 64a, 64b of the suture loop
62 through a loop 70 of a short snare 72, as shown in FIG. 4A. The
short snare 72 is then pulled distally out of the bone anchor 42,
as shown in FIG. 4B, in the process causing the suture to also be
drawn through the anchor 42 and a loop 74 of a long snare 76. The
long snare 76 (FIG. 4C) extends through the nosepiece 14, handle
12, and anchor 42, and is then pulled proximally by the
practitioner and removed from the device 10 (FIG. 4C). This causes
the suture to be threaded through the entire assembly to its
proximal end. Most importantly, as shown in FIG. 7A, for example,
the suture loop is wrapped about the pin member 56. The suture is
then secured to a fixation slit 78 on the suture ratchet wheel 20,
as shown in FIG. 4D.
[0082] Now, it is time to insert the bone anchor device 10 into a
hole 80 which has been previously drilled into the humerus bone 60,
as shown in FIG. 6A. The practitioner preferably guides the
instrument 10 distally along the suture, using the suture as a kind
of guide wire, until the bone anchor 42 is at a desired depth
within the hole 80, beneath the cortical bone. At this juncture,
the function lever 28 is moved to its lowest position (FIGS. 3A and
5B), which is the "cortical lock" position.
[0083] At this point, it is time to deploy the bone anchor toggle
ring member 46. This is done by actuating the pivotable hand lever
22 downwardly a desired number of times, which causes a pinion 84
to engage successive teeth 86 on the rack mechanism 68, thereby
driving the rack mechanism proximally, and, in turn, drawing the
pull tube 38, to which the rack mechanism is attached, proximally.
The proximal movement of the pull tube 38 will draw the toggle ring
member 46 proximally against the distal end of the mandrel tube 34,
thereby causing the thin struts 50 to deform and the toggle ring
member to deploy radially, as shown in FIGS. 6B and 6C. As shown in
FIG. 5C, because the function lever 28 is in the cortical lock
position, a stop 88 is in place to engage a portion 90 of the rack
mechanism after the rack has moved proximally a predetermined
distance. The purpose of this is to prevent the pull tube 38 from
being drawn proximally too far, prior to the upcoming suture
tensioning step.
[0084] Thus, when the stop 88 has been reached, preventing further
actuation of the hand lever 22, the suture support lever 69 is
pivoted back to its lower orientation, to release the suture. Then,
the suture tensioning step is commenced. This step involves
tensioning the suture loop 62 sufficiently to ensure that the soft
tissue 58 is approximated, as desired by the practitioner, to the
bone 60. The suture is tensioned by rotating the suture knob 18 in
order to, in turn, rotate the suture ratchet wheel a desired number
of increments, until the desired approximation has occurred, due to
tensioning of the suture. This step is illustrated, sequentially,
in FIGS. 6D and 7A. The use of the suture ratchet wheel 20 to
tension the suture in the present invention is particularly
advantageous in that it permits one-handed operation, freeing the
other hand for other functions, such as camera operation.
[0085] Once the suture tensioning step has been completed, the
function lever 28 is returned to the center position, which is the
suture lock position (FIG. 3). This step is shown in FIG. 5D, and
causes the portion 90 of the rack mechanism 68 to be lifted
upwardly above the stop 88, so that the two members are no longer
engaged. As a result, the handle 22 may be actuated once again to
further draw the pull tube 38 proximally in order to draw the
suture plug 52 proximally to lock the suture in place.
[0086] Referring particularly to FIG. 7A, there may be seen a tab
94 formed at the end of the pull tube 38 and attached by welding or
other suitable means to the anchor 42. Since the toggle ring 46 has
been completely deployed and now abuts the mandrel tube 34, further
pulling on the pull tube 38 serves to fracture the attachment of
the pull tube 38 to the anchor 42 at the tab 94, and thus
transforms the distal to proximal movement of the pull tube 38 into
a direct linear translation of the suture plug 52, via the
actuation member 54. The practitioner will therefore actuate the
hand lever 22 accordingly, to draw the suture plug 52 proximally,
as shown in FIG. 7B, such that the suture is immobilized, as shown,
between the suture plug and the adjacent walls of the anchor body
44. FIG. 5E illustrates the continued movement of the rack
mechanism 68, responsive to continued actuation of the handle 22,
to retract the suture plug. Because of the design of the actuation
member 54, which attaches the pull tube 38 to the suture plug 52,
to include a predetermined fracture point, continued actuation of
the handle 22 after the suture plug has immobilized the suture in
place will cause the actuation member 54 to fracture, thereby
separating the device 10 from the anchor body 44. The device 10 may
then be withdrawn proximally from the procedural site, as shown in
FIG. 8A, and the sutures trimmed, as shown in FIGS. 8B and 8C.
[0087] FIGS. 5F and 5G illustrate, sequentially, the steps for
re-loading the driver 10, in the event that more than one suture is
desired (as will be typically the case). To reload the driver, a
new pull tube is inserted into the driver device 10, as shown, in a
manner substantially identical to that described above, and all of
the foregoing procedural steps may be repeated as many times as
desired.
[0088] Preferably, the driver device 10 is constructed to be a
reusable device, and the pull tube and anchor portions are
disposable. However, it is possible to construct the driver device
10 to be disposable as well, if desired.
[0089] It is to be understood that the disclosed invention is
applicable to many different types of procedures involving, in
particular, the attachment of connective or soft tissue to bone. It
is also to be understood that the specific mechanisms disclosed
herein may be modified, using substantially equivalent mechanisms,
within the skills of those of ordinary skill in the art, to effect
the same or similar mechanical movements and functions. All of the
terms used herein are descriptive rather than limiting, and many
changes, modifications, and substitutions may be made by one having
ordinary skill in the art without departing from the spirit and
scope of the invention. The scope of the invention is, therefore,
indicated by the appended claims rather than by the foregoing
description. All changes which come within the meaning and range of
equivalency of the claims are to be embraced within their
scope.
* * * * *