Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Ligament or tendon
Reexamination Certificate
1998-08-03
2001-04-24
Milano, Michael J. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Ligament or tendon
C623S013130, C623S013190
Reexamination Certificate
active
06221107
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to fixation of ligament grafts.
When a ligament ruptures, it is usually replaced by a ligament graft or a prosthetic ligament. In many cases, a ligament graft is preferable because prosthetic ligaments can wear out.
For example, the anterior cruciate ligament (ACL) when ruptured, often requires replacement and a graft is preferred.
In such ACL reconstruction procedures, a bone tunnel is created through the tibia and one through the femur. The ligament graft is then affixed to each bone tunnel by a variety of means, with the goal that the graft will securely heal to the bone in the tunnel.
Presently available techniques are not satisfactory in all respects.
SUMMARY OF THE INVENTION
According to one aspect of the invention a device is provided for attaching a ligament graft to the inside of a bone tunnel from its proximal aspect (extra-articular point of access). The device comprises: a non-expansible ring having an-interior passage through which the ligament graft may extend, the ring sized and adapted to fit within and be secured in the bone tunnel; a radially expansible gripping member sized to enter the ring and to press the ligament outwardly against the interior surface of the ring; and an expander coupled to the expansible gripping member, constructed to expand the expansible gripping member to grip and secure the ligament against the ring.
Preferred embodiments of this aspect of the invention have one or more of the following features.
The gripping member, when in position within the ring, has a distal portion extending beyond the ring that positions a corresponding portion of the ligament near or against the surface of the bone tunnel, in the path of in-growing bone.
The ring is rigid.
The ring includes at least one aperture disposed to permit in-growth of bone through the side of the ring and about the ligament graft.
The device further comprises at least one strut extending distally from the ring and a distal member is disposed at the distal end of the strut in position to limit distal movement of the gripping member. Preferably there are one strut or two spaced apart struts that extend distally, in supporting relationship with said distal member. Preferably the distal member is a base from which a threaded rod extends proximally through the ring passage, the gripping member being expanded by a threaded expander engaged upon the threaded rod, preferably the threaded expander being of wedge form, arranged to radially wedge apart portions of the expansible gripping member.
Preferably, in the foregoing case or generally, a strut extends proximally from the ring to a securing member attached to its proximal end, the securing member being constructed and arranged to engage an exterior surface of the bone to secure the ring in the cortical region of the bone passage.
The expansible gripping member comprises a set of circumferentially arranged proximally extending leg portions constructed and arranged to be splayed apart by the wedging action of a centrally introduced expander member, preferably the exterior surface of the gripping member leg portions have ligament gripping projections. In certain preferred embodiments the gripping projections comprise portions of at least one barb or ledge and preferably an axially spaced set of, circumferential ledge or barb and in other preferred embodiments the gripping projection comprise screw threads, including lands, preferably of helical form.
The ring supports a threaded rod that extends through the gripping member, in combination with a threaded expander wedge member constructed and arranged to be threaded on the threaded rod into the expansible gripping member in a wedging relationship.
The expansible gripping member supports a threaded rod extending proximally from the gripping member in combination with a threaded expander wedge constructed and arranged to be threaded on the threaded rod into the expansible gripping member in a wedging relationship.
An expansible gripping member has a distally extending formation arranged to deflect to lock the gripping member in position relative to the ring, preferably this formation comprising a set of circumferentially arranged, resilient fingers that are preferably integral with the main body of the gripping member.
An expansible gripping member has screw threads on its exterior that are disposed to engage and thread into ligament graft lying between the ring and the gripping member during advance of the gripping member.
The expansible gripping member supports a threaded rod extending proximally from the gripping member in combination with a threaded expander wedge threaded into the gripping member for a wedging relationship.
According to another aspect of the invention a device is provided for attaching a ligament graft to the inside of a bone tunnel from its proximal aspect (extra-articular point of access), the device comprising: a non-expansible structure ledge providing an interior passage through which the ligament graft may extend, the structure sized and adapted to fit within and be secured in the bone tunnel; a gripping member sized to be opposed to the ledge structure and to grip the ligament against a portion of the structure; and at least one strut extending distally from the portion of the ledge structure against which the ligament is gripped, a distal member disposed at the distal end of the strut in position to limit distal movement of the gripping member.
In preferred embodiments of this aspect of the invention the gripping member is expansible radially to grip the ligament against the ledge structure and position the ligament for incorporation by in-growth of bone from the wall of the tunnel. Preferably the ledge structure is carried on a continuous ring.
According to another aspect of the invention a device is provided for attaching a ligament graft to the inside of a bone tunnel from an extra-articular location, the device comprising: a rigid ring having an interior passage through which the ligament graft may extend, the ring sized and adapted to fit within and be secured in the bone tunnel; a gripping member constructed and arranged to grip a ligament graft against the interior surface of the rigid ring; and at least one strut extending proximally from the ring, a securing member attached to the proximal end of the strut, the securing member sized to engage an exterior surface of the bone to secure the ring in the cortical region of the bone tunnel.
Preferably the peripheral outer surface of the ring is cylindrical.
Preferred embodiments of this aspect of the invention have a bone-penetrating formation carried by the securing member.
Preferably the securing member is a flange extending laterally from the axis of the passage; preferably the flange has bone-penetrating formation, preferably projecting distally toward the bone.
In other embodiments the securing member is a flange having a hole sized to receive an awl-like tool to hold the member in position against rotation while a portion of the device is turned during the procedure.
Preferably, the gripping member is expansible to grip the ligament against the ring, and an expander is coupled to the expansible gripping member, constructed to expand the gripping member to grip the ligament against the ring.
Preferably the gripping member, when in position within the ring, has a distal portion extending beyond the ring that positions a corresponding portion of the ligament near or against the surface of the bone passage in the path of in-growing bone.
According to another aspect of the invention, a device is provided for attaching a ligament graft to the inside of a bone tunnel from its proximal aspect, the device comprising: a non-expansible ring having an interior passage through which the ligament graft may extend, the ring sized and adapted to fit within and be secured in the bone passage; strut portions extending proximally and distally from the ring; a securing member attached to the end of the proximally-extending strut portion, the securing member sized to engage
Burke Dennis W.
Prudden, Jr. John
Steiner Mark E.
Fish & Richardson P.C.
Milano Michael J.
Steiner Mark E.
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