Surgery – Instruments – Suture retaining means
Reexamination Certificate
2000-06-28
2002-03-12
Chaudhuri, Olik (Department: 2814)
Surgery
Instruments
Suture retaining means
C606S075000
Reexamination Certificate
active
06355053
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to fixation devices or anchors and tools and methods for emplacing same. The present invention, in particular, relates to medical anchors, e.g., suture anchors or prosthesis anchors. It further relates to a method and apparatus for emplacing an anchor in biological material, for example, bone. Even more particularly, the present invention relates to a medical anchor which can be inserted through a longitudinally extending borehole so that the anchor is initially substantially aligned with the borehole and then, via an emplacement tool, manipulated so that the anchor pivots in two axes to form an undercut in the borehole and is secured substantially perpendicularly to the longitudinal extent of the borehole. The present invention is particularly suitable for the emplacement of anchors adapted to repair ligaments, e.g., rotator cuff ligaments, anterior cruciate ligaments (ACL's) and other ligaments. The anchor is also suitable for prosthesis fixation.
In Applicant's co-pending U.S. patent application Ser. No. 08/470,988, filed Jun. 6, 1995, a medical anchor is disclosed which can be emplaced in a groove which extends substantially parallel to the surface of the bone. The anchor of that patent application is placed in the groove, and then rotated along an axis defined by the tool (and which axis is perpendicular to the extent of the groove) to form an undercut in the walls of the groove in the bone to secure the anchor. The anchor of that application is suitable for repairing rotator cuff injuries, for example.
Applicant is also aware of U.S. Pat. No. 5,203,787 to Noblitt et al., in which a suture anchor can be emplaced in bone. This anchor is inserted in a longitudinally extending hole and then is twisted into place by manipulation of the sutures so that the suture anchor pivots along an axis which is perpendicular to the longitudinal axis of the borehole.
U.S. Pat. No. 5,569,302 to Johnson describes an apparatus and method for attaching an object to bone in which a special tool is provided to form a groove which extends both longitudinally parallel to the bone and distally into the bone and a special tool is utilized to form an undercut into which the anchor is fitted.
The various prior art devices suffer from a number of defects. In the above-described co-pending patent application, although a securely emplaced anchor is obtained by using the device of that patent application, it is necessary to form a groove which extends essentially parallel to the surface of the bone. This is a more time consuming task than simply drilling a borehole. The Noblitt et al. device requires the manipulation of the sutures to emplace it, which may result in an unreliable emplacement, and furthermore, requires a complex manipulation. The Johnson reference requires a first tool for the formation of a specialized groove which extends both essentially parallel to the surface of the bone and distally into the bone and a another tool to form the undercut for the anchor. Accordingly, the Johnson device and method is unnecessarily complex.
There is a need in the medical art for an anchor which can be emplaced simply and which is securely fastened into the bone.
There is a need also for a tool for installing such an anchor with simple motions, and preferably one simple motion.
There is a need particularly for such an anchor which can be inserted into a simple longitudinally extending borehole, i.e., a drilled borehole, and which does not require complex, time consuming-to-make grooves or other specialized manipulations.
There is a need for an anchor which can be inserted into a borehole substantially in alignment with the borehole and once inserted, activated so that it engages with the walls of the borehole by moving to a position substantially perpendicular to the borehole.
Such an anchor would be suitable, for example, to repair rotator cuff and other ligament injuries such that the appropriate attachment strength is provided.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide an anchor which can be easily emplaced and which provides sufficient strength for the attachment of prosthesis or sutures for the reattachment of, for example, ligaments, e.g., the rotator cuff or ACL ligaments.
Yet still a further object of the present invention is to provide an anchor which can be inserted in a distally extending borehole and which is adapted to be rotated in two axes so as to form an undercut in the borehole into which the anchor is secured.
Yet still a further object of the present invention is to provide such an which can be inserted longitudinally into a borehole and which can be emplaced so that the anchor rotates into an undercut which the anchor itself cuts into the borehole, the anchor rotating about one axis extending perpendicular to the borehole and another axis extending along the longitudinal axis of the borehole.
Yet still a further object of the present invention is to provide a tool for emplacing the described anchor and for performing the manipulations to form the undercut and secure the anchor in the borehole.
The above and other objects are achieved by a method for emplacing a medical anchor in a borehole in biological tissue, the method comprising the steps of providing a borehole in the biological tissue, inserting the anchor into the borehole with a tool such that the anchor is affixed to the tool and in approximate alignment with the borehole, manipulating the tool, the step of manipulating the tool causing the anchor to pivot about an axis perpendicular to the borehole and further comprising rotating the anchor in the borehole about the axis of the borehole, thereby causing the anchor to move outwardly in the borehole to engage a wall of the borehole and cut into the wall of the borehole and secure the anchor in a final position in the borehole such that the anchor is disposed approximately perpendicularly to the axis of the borehole; and removing the tool from the borehole by moving the tool proximally in the borehole, thereby separating the anchor from the tool and leaving the anchor secured in the borehole.
The above and other objects are also achieved by a medical anchor for emplacement in a borehole in a biological tissue member, the anchor comprising a central portion, at least one outer portion attached to the central portion, the outer portion having a cutting edge, the anchor being adapted to be inserted in the borehole in approximate alignment with a longitudinal axis of the borehole, and further being adapted to be rotated in two axes to secure the anchor in the borehole, a first axis of rotation being aligned with the axis of the borehole and a second axis of rotation being perpendicular to the axis of the borehole, whereby the anchor moves outwardly about the second axis so that the cutting edge cuts into a wall of the borehole and the anchor is rotated about the first axis to achieve a final position substantially perpendicular to the borehole.
The above and other objects are furthermore achieved by an apparatus for emplacing a medical anchor in a borehole in biological tissue the anchor comprising a member having at least one portion adapted to cut into a wall of the borehole to secure the anchor in the borehole, the apparatus comprising a handle having a gripping surface, a shaft having a first longitudinal axis, the shaft being attached to the handle and having a distal end for insertion in the borehole, the distal end having a pivoting receptacle for receiving the anchor initially in a position approximately aligned with the first axis, a pushing member movable distally with respect to the shaft to push on the anchor in the pivoting receptacle, the shaft being rotatable about the first axis, the pushing member being movable distally with respect to the shaft to rotate the anchor in the pivoting receptacle about a second axis substantially perpendicular to the shaft, thereby causing the at least one portion of the anchor to move outwardly and cut into the wall of the borehole t
Chaudhuri Olik
Li Medical Technologies Inc.
Ostrolenk Faber Gerb & Soffen, LLP
Trinh (Vikki) Hoa B.
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