U.S. patent number RE34,871 [Application Number 07/887,200] was granted by the patent office on 1995-03-07 for process of endosteal fixation of a ligament.
Invention is credited to E. Marlowe Goble, David A. McGuire, W. Karl Somers.
United States Patent |
RE34,871 |
McGuire , et al. |
March 7, 1995 |
Process of endosteal fixation of a ligament
Abstract
A cannulated interference screw (10) and process for human
implantation in an arthroscopic surgical procedure for replacement
of a ligament, or the like. The interference screw is provided with
a drill end (11) that extends longitudinally from an end of a
cylindrical body (14), which drill end includes equally spaced
flutes (12) therearound. The flutes extend into first and second
cutting threads (15a) and (15b), respectively which cutting threads
and threads (15) are formed around the cylindrical body. A center
longitudinal passage (16) is formed through the interference screw
drill end and cylindrical body, which passage is stepped outwardly
within the cylindrical body into a hexagonal sided section (18)
that is for receiving a sided end (20) of a driver (19) that is
fitted therein. In practice, the cannulated interference screw is
installed by sliding it along a guide rod (25) that is fitted in a
prepared ligament tunnel (22) through a bone mass, alongside a bone
block portion of a ligament (23) within the bone endosteum, which
ligament is maintained in that tunnel under tension. The driver is
also holed longitudinally to travel along the guide rod to fit into
and turn the interference screw, providing fixation of the ligament
in that tunnel.
Inventors: |
McGuire; David A. (Anchorage,
AK), Goble; E. Marlowe (Logan, UT), Somers; W. Karl
(Logan, UT) |
Family
ID: |
23384003 |
Appl.
No.: |
07/887,200 |
Filed: |
May 21, 1992 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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Reissue of: |
352153 |
May 15, 1989 |
04927421 |
May 22, 1990 |
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Current U.S.
Class: |
606/99; 606/104;
606/96; 623/13.12 |
Current CPC
Class: |
A61F
2/0811 (20130101); A61F 2/0805 (20130101); A61F
2002/0841 (20130101); A61F 2002/0858 (20130101); A61F
2002/087 (20130101); A61F 2002/0882 (20130101) |
Current International
Class: |
A61F
2/08 (20060101); A61F 002/08 () |
Field of
Search: |
;606/88,73,86,96,97,98,104 ;623/13,22
;411/393,395,414,307,408,403,404,426 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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645252 |
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0282789 |
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1548276 |
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FR |
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2194445 |
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0000 |
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GB |
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1197654 |
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0000 |
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SU |
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Other References
Kurosaka Fixation Screw--Directions for Use; DePuy, Oct. 1987,
Warsaw, Ind. .
Techniques in Orthopaedics; McGinty, 1985, Rockville, Md., Chapter
6, pp. 63-84, see in particular p. 68. .
Kariya and Kurosawa; Arthroscopically Aided Anterior Cruciate
Ligament Reconstruction Using a New Drill Wire Guide, 1989, The
Journal of Arthroscopic and Related Surgery, vol. 5, No. 3, pp.
227-231. .
Hanson and Frost; A Simple Suture Passer for Use in Cruciate
Ligament Repair in the Knee, 1977, Clinical Orthopaedics and
Related Research, pp. 45-46. .
Jones; Results of Use of the Central One-Third of the Patellar
Ligament to Compensate for Anterior Cruciate Ligament Deficiency,
1980, Clinical Orthopaedics and Related Research, pp. 39-44. .
Odensten and Gillquist; A Modified Technique for Anterior Cruciate
Ligament (ACT) Surgery Using a New Drill Guide for Isometric
Positioning of the ACL, 1976, Clinical Orthopaedics and Related
Research, pp. 154-158. .
Beyer; A Unitunnel Technique for Arthroscopic Anterior Cruciate
Ligament Reconstruction, 1988, Bulletin of the Hospital for Joint
Diseases Orthopaedic Institute, vol. 48, No. 2, pp. 164-169. .
Rosenoff, Antelyes, and Buonavita; A Modified Intramedullary Pin
for Placement of a Prosthetic Cruciate Ligament, Sep. 11966,
Journal Amer. Veterinary Medical Assoc., pp. 523-524. .
Burnett and Fowler; Reconstruction of the Anterior Cruciate
Ligament: Historical Overview, Jan. 1985, Orthopedic Clinics of
North America, vol. 16, No. 1, pp. 143-157. .
Verheyden; An Inexpensive Wire Passer, Dec. 1986, Plastic
Reconstruction Surgery, pp. 820-821. .
Raunest; Application of a New Positioning Device for Isometric
Replacement in Anterior Cruciate Ligament Repair and
Reconstruction, Feb. 1991, The Journal of Trauma, vol. 31, No. 2,
pp. 223-229. .
Matthews, Martin, and Wolock; Accurate Tunnel Placement Using Drill
Guides in Knee Ligament Reconstruction, Dec. 1, 1989, Orthopaedic
Review, vol. XIX, No. 9, pp. 822-824. .
Bassi and Fioriti; A New Guide in the Surgical Reconstruction of
the Cruciate Ligaments, Jun. 1990, Italian Journal of Orthopaedics
and Traumatology, pp. 215-219. .
McGinty; Arthroscopic Surgery, 1985, Techniques on Orthopaedics,
vol. 5, pp. 72-77. .
Technique for Endoscopic Patellar Tendon Bone Block Fixation Using
a Cannulated Interference Screw System. .
Richards; Orthopaedic Catalog, Richards Manuf. Co., Inc. Memphis,
Tenn., 1981 p. 145. .
Goble; Fluoroarthroscopic Allograft Anterior Cruciate
Reconstruction, Techniques Orthop 1988, 2(4):65-73 (1988). .
Edelman; Arthroscopic Bankart Suturing Yields Better External
Rotation, Orthopedics Today, 26-27 (Feb. 1989). .
Statak; Soft Tissue Attachment Device, by Zimmer, Inc. 1988. .
Arthroscopic Technique for Anterior Cruciate Reconstruction, by
Acufex Microsurgical, Inc. 1988. .
Technique for Rear Entry ACL Guide, by Acufex Microsurgical, Inc.
1988. .
Kurosaka, M.; Fixation Screw. .
Lambert, K.; Vascularized Patellar Tendor Graft with Rigid Internal
Fixation for Anterior Cruciate Ligament Insufficiency, Jul. 1982,
pp. 85-89. .
Kurosaka, et al.; A Biomechanical Comparison of Different Surgical
Techniques of Graft Fixation in Anterior Cruciate Ligament
Reconstruction, Americal Journal of Sports Medicine, vol. 15, No.
3, 1987, Cleveland, Ohio, pp. 225-229. .
Nikolaou, P. K., "Anterior Cruciate Ligament Allograft
Transplantation, Long-term Function, Histology, Revascularization,
and Operative Technique," The American Journal of Sports Medicine,
vol. 14, No. 5, pp. 348-360 (1986). .
Lambert, K. L. and Cunningham, R. R., "Anatomic Substitution of the
Ruptured ACL Using a Vascularized Patellar Tendon Graft with
Interference Fit Fixation," The Crucial Ligaments, Chapter 21, pp.
401-408..
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Primary Examiner: Hafer; Robert A.
Assistant Examiner: Kenealy; David J.
Attorney, Agent or Firm: Bromberg & Sunstein
Claims
We claim: .[.
1. A process of endosteal fixation of a ligament within the
interior of a bone mass comprising, forming a ligament tunnel
through adjacent bone masses; fitting a ligament under tension in
said ligament tunnel, extending between said adjacent bone masses;
and turning a threaded device into one end of said ligament tunnel,
guiding it alongside the ligament, such that the threads of said
threaded device turn into said tunnel wall and a bone block end
portion of said ligament..].
2. A process of endosteal fixation .[.as recited in claim 1.].
.Iadd.of a ligament within the interior of a bone mass comprising,
forming a ligament tunnel through adjacent bone masses; fitting a
ligament under tension in said ligament tunnel, extending between
said adjacent bone masses; and turning a threaded device into one
end of said ligament tunnel, guiding it alongside the ligament,
such that the threads of said threaded device turn into a wall of
said tunnel and a bone block end portion of said ligament.Iaddend.,
wherein the threaded device is cannulated and is .[.arranged for
travel and turning.]. .Iadd.guided .Iaddend.along a guide wire that
is fitted into the ligament tunnel, alongside the ligament. .[.3. A
process of endosteal fixation as recited in claim 1, wherein the
threaded device has a threaded body and includes a drill extending
from one or a first end with an arrangement for fitting a driver
formed in the
other or second end..]. 4. A process of endosteal fixation .[.as
recited in claim 3.]. .Iadd.of a ligament within the interior of a
bone mass comprising, forming a ligament tunnel through adjacent
bone masses; fitting a ligament under tension in said ligament
tunnel, extending between said adjacent bone masses; and turning a
threaded device into one end of said ligament tunnel, guiding it
alongside the ligament, such that the threads of said threaded
device turn into a wall of said tunnel and a bone block end portion
of said ligament.Iaddend., wherein .Iadd.the threaded device has a
threaded body and includes a drill extending from one or a first
end with an arrangement for fitting a driver formed in the other or
second end and .Iaddend.the threaded device and driver are both
cannulated .[.to travel.]. .Iadd.and guided .Iaddend.along a guide
wire that is .[.for fitting.]. .Iadd.fitted .Iaddend.into the
ligament tunnel, alongside the bone block end portion of the
ligament. .Iadd.5. A process of endosteal fixation of a ligament
within the interior of a knee comprising:
forming a tunnel, having an interior wall, through a tibia and an
adjacent femur;
fitting a ligament secured between two bone blocks into said
tunnel;
fitting a guide wire into said tunnel alongside one of said bone
blocks;
telescoping a cannulated interference screw over said guide
wire;
telescoping a cannulated driver over said guide wire to engage a
rear end of said interference screw with said driver; and
turning said driver so as to turn said interference screw causing
cutting threads on said interference screw to dig into the tunnel
wall and said
one of said bone blocks. .Iaddend. .Iadd.6. A method according to
claim 2, wherein the threaded device has a generally cylindrical
body and threads formed about the body from a last thread extending
from the rear of the body to a first thread, the first thread
having a smaller outer diameter than the last thread, and wherein
the threads form the radially outermost projection from the body.
.Iaddend. .Iadd.7. A method according to claim 5, wherein the
interference screw has a generally cylindrical body and threads
formed about the body from a last thread extending from the rear of
the body to a first thread, the first thread having a smaller outer
diameter than the last thread, and wherein the threads form the
radially outermost projection from the body. .Iaddend.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to fixation devices and more particularly to
arrangement for anchoring a ligament in a bone mass.
2. Prior Art
Until recently, in ligament repair and/or replacement surgery
involving securing of one or both ligament ends to a bone mass have
been accomplished utilizing staples, or like fixation devices, that
are driven through or across the ligament and into the bone mass.
Such ligament anchoring has involved connecting the ligament end to
the bone mass exterior, requiring, for a knee cruciate ligament
procedure, that the replacement ligament end or ends extend onto
the periosteum or outside bone surface beyond a ligament tunnel
with each end bent and secured onto the bone mass surface. Such
ligament bending, of course, may result in a force concentration at
that bend, weakening and potentially subjecting the ligament to
rupture.
An earlier patent issued to two of the present inventors in a
"Suture Anchor Assembly", U.S. Pat. No. 4,632,100, addresses
anchoring a suture to a bone mass surface for joining a ligament
thereto, but does not address securing a ligament in a ligament
tunnel, as does the present invention. Another patent issued to two
of the present inventors in a "Ligament Attachment Method and
Apparatus", U.S. Pat. No. 4,772,286 does involve an endosteal
fixation device for securing, at a certain tension, a ligament in a
ligament tunnel. End coupling arrangements including a threaded
flattened cone, expanding cone, and threaded cylindrical end
anchors, that are taught by this patent, however, are structurally
and functionally unlike the present invention. Also, still another
invention of two of the present inventors in a "Ligament Anchor
System", filed as a U.S. patent application, Ser. No. 289,728 is
also an endosteal fixation system that includes a sleeve for
turning in a tapped cortex, the sleeve to receive a footing turned
therein that mounts a ligament. None of the inventions set out in
these patents or in the patents cited therein or as were cited
during the individual applications prosecutions, however, involve
wedging a ligament bone block portion in a ligament tunnel as
taught by the present invention.
The interference screw of the present invention is similar in
construction to the anchor shown and described in the above-cited
U.S. Pat. No. 4,632,100 of two of the present applicants, in that
both involve a threaded cylindrical body with a forward fluted
drill end. The patented anchor, of course, is for turning into a
bone mass, whereas the interference screw of the present invention
is cannulated for guided travel on a guide wire by a driver into
ligament tunnel, alongside a ligament fitted therein. The
interference screw of the present invention is principally for
wedging between a bone block portion of a ligament and tunnel wall,
and is accordingly both structurally and functionally unlike the
patented anchor.
BRIEF SUMMARY OF THE INVENTION
It is therefore a principal object of the present invention in an
interference screw and system to provide a device for endosteal
fixation or the surface of a bone block portion of a ligament and
the wall of a ligament tunnel formed through a bone mass.
Another object of the present invention is to provide a cannulated
interference screw having a drill end for both drilling a hole into
a bone mass followed by the interference screw threads, which
threads have at least one leading thread for cutting into that
drilled hole.
Another object of the present invention is to provide an
arrangement for guiding the cannulated interference screw between a
ligament tunnel wall and the bone block portion of a ligament
installed therein.
Still another object of the present invention is to provide a
driver and guide wires for precisely and conveniently turning the
interference screw between a ligament tunnel wall and the bone
block surface of a ligament fitted therein, the driver and guide
wire also providing an arrangement for conveniently removing the
interference screw.
Still another object of the present invention is to provide a
simple and reliable device and system for fixing a bone block
portion of a ligament within a ligament tunnel that is formed
through a bone mass.
In accordance with the above objects, the present invention is in
an interference screw and a system for its use to provide for
securing a bone block portion of one or both ligament ends under
tension within a prepared ligament tunnel that has been passed
through a bone mass. In practice, a ligament tunnel, as for
example, an anterior or posterior cruciate ligament tunnel is
prepared in the distal femur and proximal tibia portions of a
patient's knee in an arthroscopic surgical procedure. In that
procedure a surgeon monitors drilling progress on a fluoroscopic
monitor, or the like. The procedure involves both preparing the
tunnel through both the distal femur and proximal tibia bone ends
and installing either an allograft or prosthetic ligament, in that
prepared tunnel. Wherein, that ligament is maintained under
tension.
The interference screw of the present invention is to secure a bone
block portion of the ligament end or ends in the tunnel. The
interference screw preferably includes a cylindrical body with a
fluted drill on a forward end and is threaded from that fluted
drill to a rear end. The flutes of the drill are cut into the
adjacent threads to provide self-tapping sharp cutting edges, that
follow the fluted drill into a bone mass. Also, the interference
screw is cannulated, having a center longitudinal passage
therethrough that is sided on a rear end opposite to the fluted
drill end to receive a driver fitted therein.
The cannulated interference screw and driver are to slide and turn
along a guide wire that is fitted into the ligament tunnel,
alongside the bone block portion of the ligament positioned
therein. The driver turns the interference screw along the ligament
tunnel wall and ligament surface, as viewed on the fluoroscopic
monitor, to where the interference screw is appropriately
positioned so as to provide an interference fit therebetween.
Whereat, the drive and guide pin are removed.
The cannulated interference screw is removed by reinserting the
guide pin with the driver telescoped thereon along the ligament
tunnel and into the interference screw longitudinal cavity, the
drive to fit into the interference screw for turning it out of the
ligament tunnel.
DESCRIPTION OF THE DRAWINGS
In the drawings that illustrate that which is presently regarded as
the best mode for carrying out the invention:
FIG. 1 is a profile perspective view of the present invention in a
cannulated interference screw;
FIG. 2 is a side elevation view of the cannulated interference
screw of FIG. 1 showing, in broken lines, that a longitudinal
passage therethrough is stepped outwardly into a sided rear end
cavity;
FIG. 3 is a rear end elevation view of the cannulated interference
screw of FIG. 1;
FIG. 4 is a forward end elevation view of the cannulated
interference screw of FIG. 1;
FIG. 5 is a profile perspective view of a patient's knee with a
portion of the distal femur shown broken away that includes a
ligament tunnel formed through the knee and showing an anterior
cruciate ligament maintained in tension therein, the cannulated
interference screw of FIG. 1, shown fitted to slide along a guide
rod that is passed from the femur cortex ligament tunnel end,
traveling alongside a bond block portion of the ligament; and
FIG. 6 is a view of a section of the bone block portion of the
ligament and cannulated interference screw with guide rod of FIG.
5, and showing a driver that is telescoped over the guide rod that
has a sided end for fitting into the sided end of the cannulated
interference screw end.
DETAILED DESCRIPTION
FIG. 1 shows a preferred embodiment of a cannulated interference
screw 10 of the present invention, hereinafter referred to as
screw. The screw 10, as shown best in FIGS. 1 through 4, includes a
drill 11 that extends longitudinally from its forward end that
preferably incorporates three (3) longitudinal flutes 12 arranged
at one hundred twenty (120) degree intervals around the drill. The
flutes 12 extend from a drill forward or nose end 13 that, as shown
at A in FIG. 2, is angled rearwardly at approximately a thirty (30)
degree angle to the vertical. Each flute tapers outwardly along the
drill 11, as shown at B in FIG. 2, at approximately a ten (10)
degree angle from the horizontal. The flute walls are shown to
taper together passing into forward cutting threads 15a and 15b of
threads 15.
Threads 15 are formed around a cylindrical screw body 14. Shown
best in FIGS. 1, 2, and 4, the flutes 12 are shown to be spaced at
one hundred twenty (120) degree intervals from drill nose end 13 to
pass through first and second cutting threads 15a and 15b,
respectively. The cutting thread 15a is shown to have a lesser
outside diameter than that of cutting thread 15b, and the other
threads 15. The intersection walls of the cutting threads 15a and
15b at flutes 12 from walls that are preferably angled at
approximately right angles to the vertical axis of the thread as
cutting edges. Thereby, in turning the screw 10 into a bone mass,
the drill 11 will form a hole and travel into that bone mass to
where the first cutting thread 15a, at its intersection to one of
the drill flutes 12 will contact and cut into that bone mass. The
second cutting thread 15b follows the first to further deepen the
cut thread to receive the following individual threads of threads
15 turned therein. Accordingly, the arrangement of drill 11 and
threads 15 provide a single device for drilling, tapping and
seating in a bone mass. Also, while, as shown best in FIG. 2, the
threads are preferably tapered, they need not be within the scope
of this disclosure.
Shown in broken lines in FIG. 2, the drill 11 and screw body 14
include a center longitudinal passage 16 therethrough that is
preferably stepped outwardly at 17 into a sided rear section 18.
The sided rear section 18 walls are preferably hexagonal to
receive, as shown in FIG. 6, a hexagonal shaped end 20 of a driver
19 that is fitted therein for turning screw 10. Which driver
opposite end 21 is arranged to receive a chuck of a tool, not
shown, that is either manually or motor driven for turning the
driver, as set out below.
FIG. 5 shows a patient's knee with a portion of the distal femur
cut away, exposing an anterior cruciate ligament tunnel 22,
hereinafter referred to as ligament tunnel, that is formed therein,
and extends across the knee through both the distal femur and
proximal tibia. The ligament tunnel is shown to open at the tibial
tuberosity and anterolateral femoral cortex ends of that ligament
tunnel. The ligament tunnel 22 is preferably formed by conventional
surgical procedures, such as, for example, the procedure set out in
the patent of two of the applicants, U.S. Pat. No. 4,772,286, or by
like procedure, within the scope of this disclosure.
As shown in FIG. 5, a ligament 23, that can be a prosthetic or
allograft ligament, or the like, is fitted into the ligament tunnel
22. Sutures 24 are shown connected to the ligament ends that extend
out from the ligament tunnel ends and are for use in applying a
tensile force on the ligament. So arranged, to install the screw 10
for providing an interference fit between the ligament tunnel 22
wall and a bone block side portion of ligament 23, a surgeon,
observing on a fluoroscopic monitor, or the like, fits a guide rod
25 through an end of the ligament tunnel 22, sliding it along the
bone block portion of the ligament.
With the guide rod 25 installed as shown in FIG. 5, a surgeon can
fit or telescope the longitudinal passage 16 of screw 10 onto the
guide rod 25. A center passage 26 of the driver 19 is then fitted
or telescoped onto that guide rod, and passed therealong until the
driver sided end 20 fits into the sided end 18 of the screw
longitudinal passage 16. The driver 19 is then mounted to the drill
11 end 13 for turning into and between the ligament tunnel 22 and
ligament 23 providing an endosteum or endosteal fixation
therebetween. In that turning, the screw 10 travels to the attitude
shown in FIGS. 5 and 6. Whereat, the guide rod 25 can be pulled out
of the screw and ligament tunnel providing an endosteum or
endosteal fixation, the screw installed therein prohibiting the
bone block portion of the ligament 23 from being pulled out of that
ligament tunnel 22. In practice, the screw 10, installed as shown
in FIG. 5, has prohibited a bone block portion of the ligament 23
from removal from ligament tunnel 22 to an applied tensile force of
approximately one hundred fifty (150) pounds. Which force is well
above a maximum anticipated tensile stress in running of
approximately eighty (80) pounds.
It should be understood that the installation of the screw 10 in
the proximal tibia portion of the ligament tunnel 22 is like that
described above for screw installation in the distal femur portion
of that ligament tunnel. Also, as desired, within the scope of this
disclosure, more than one screw per tibial and femoral endosteum
ligament tunnel sections can be used for increasing ligament
holding strength, as desired and, rather than fitting the screw
into the ligament tunnel, alongside the bone block portion of the
ligament, a hole can be drilled across the ligament tunnel, through
the bone block portion and the screw turned therethrough.
The screw 10 is preferably manufactured from a material that is
suitable for sterilization and human implantation and, in practice,
the preferred screw is manufactured from a titanium or type 316
stainless steel. It should, however, be understood, screw 10 can be
manufactured from any material that is suitable for human
implantation, to include a bio-degradable material such as a
bio-erodible plastic, or the like, providing such a biodegradable
material is sufficiently hard to provide the described
functions.
While a preferred embodiment of the invention in an interference
screw and its use has been shown and described herein, it should be
apparent that this disclosure is made by way of example only and
that variations to the invention are possible within the scope of
this disclosure without departing from the subject matter coming
within the scope of the following claims and a reasonable
equivalency thereof, which claims we regard as our invention.
* * * * *