Surgery – Instruments – Orthopedic instrumentation
Reexamination Certificate
2002-02-05
2004-07-13
Jackson, Gary (Department: 3731)
Surgery
Instruments
Orthopedic instrumentation
C606S232000, C606S057000
Reexamination Certificate
active
06761722
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to surgical devices and methods and, more particularly, to devices and methods for the repair of bone and soft tissue.
It is a common requirement in orthopedic surgical procedures to anchor two or more elements together, such as pieces of a bone, two or bones, or a combination of soft tissue and bone. This has been accomplished by a number of devices, such as bone bolts that penetrate two pieces of bone and use a nut to draw the segments together, bone screws and interconnecting plates, wires circling at least two pieces of bone, or sutures into the tissue.
Often such devices require a relatively large access opening through surrounding and/or covering tissue to implant the anchoring devices. The enlarged access site may increase patient pain and lengthen recovery time. Further, in some locations it is difficult and impractical to make large access points to reach the appropriate site because of surrounding joints and vessels. Even with devices that penetrate the tissue in a substantially linear manner, i.e. lag bolts, the fracture must often be reduced before drilling and insertion of the bolt. Further, some of these devices may be difficult to use since it may be hard to reduce a fracture between two bone segments and maintain that reduction while the device is inserted. This is particularly true with small bone fragments where the use of threaded implants may tend to rotate one bone segment with respect to another, thereby creating a misalignment between the fragments.
Cerclage systems provide an alternative to implants that must penetrate the bone to achieve fixation. Such devices have been taught by Miller et al. (U.S. Pat. No. 5,312,410) and Songer et al. (U.S. Pat. No. 5,536,270). These systems rely on passing a cable around two segments of bone and then tensioning the cable to squeeze the bone segments together. A significant drawback of these systems is that they require access around the entire bone.
Therefore, there remains a need for a convenient and effective system for securing two segments of tissue together. Such a system should preferably be operable through a relatively small insertion opening or openings to securely hold two tissue segments.
SUMMARY OF THE INVENTION
An anchor system according to the present invention can comprise an elongated flexible member having a diameter, a proximal end, a distal end and a longitudinal axis; an anchor having a proximal end, a distal end, a central portion between the proximal end and the distal end and a longitudinal axis extending between the proximal end and the distal end, the anchor including a longitudinal slot extending longitudinally from the proximal end to the central portion, the slot having a width greater than the flexible member diameter, the flexible member distal end affixed adjacent the central portion. The anchor is moveable relative to the flexible member between a first position wherein the longitudinal axes of the flexible member and the anchor are generally parallel with a portion of the flexible member adjacent the distal end residing within the slot and a second position wherein the longitudinal axes of the flexible member and the anchor are generally perpendicular.
Another embodiment of an anchoring system according to the present invention, comprises an elongated flexible member having a proximal end, a distal end and a first diameter; and an anchor affixed to the distal end, the anchor moveable between an insertion configuration adapted for insertion through a tissue opening and an anchoring configuration adapted to inhibit passage through the tissue opening, the insertion configuration having a second diameter less than twice the first diameter, and the anchoring configuration having a third diameter greater than the second diameter.
The system further includes a delivery device having a distal end, the distal end adapted to releasably receive at least the anchor proximal end for releasably retaining the anchor in the first position for insertion through at least a portion of a section of tissue, the anchor releasable from the delivery device for anchoring the flexible member in the section of tissue. The delivery device includes a mechanism for releasably exerting a longitudinal force on the flexible member in a proximal direction, for retaining the anchor proximal end in the delivery device and thereby in the first position.
In one embodiment, the insertion device comprises an inner tube having a longitudinal bore extending from a proximal end to a distal end, the inner bore sized to permit passage of an elongated flexible member and to prevent passage of an anchor attached to an elongated flexible member; an outer tube having a longitudinal bore extending from a proximal end to a distal end, the outer tube bore dimensioned to permit the inner tube to pass therethrough; and a mechanism for applying tension to an elongated flexible member, the means positioned adjacent the distal end of the inner tube.
The system of the present invention further contemplates a crimping tool which can comprise an outer member having an inner passage and a distal end having an outer diameter. A crimping mechanism can be disposed within the inner passage adjacent the distal end. The crimping mechanism movable with respect to the outer member between a crimping position and an open position.
An alternative embodiment of the present invention includes a suture anchoring system for attaching a first section of tissue to a second section of tissue via a unitary incision having a longitudinal axis. The anchoring system comprises a suture anchor connected to a suture material having a first end, a second end, a longitudinal axis, and a diameter. The suture anchor has a longitudinal axis generally extending from a proximal end to a distal end and a first cross-sectional dimension generally along the longitudinal axis greater than a second cross-sectional dimension generally perpendicular to the longitudinal axis. The system further includes a mechanism for slidably affixing a central portion of the suture material to the suture anchor, the first end and the second end of the suture material retainable outside the incision. The suture anchor is pivotable relative to the suture material between a first position wherein the longitudinal axes of the incision and the suture anchor are generally parallel and a second position wherein the longitudinal axes of the incision and the suture anchor are generally perpendicular.
The present invention also contemplates a bone opening protector having a first portion defining an opening therein to receive a cable. The first portion is adapted to engage a surface surrounding a bone opening. The protector also includes an anchoring extension, connected to the first portion, adapted to extend into bone to inhibit movement of the first portion.
The invention further contemplates a method for joining two sections of tissue. The method includes providing a first anchor, an elongated member attached to the first anchor, a second anchor slidable on the elongated member and having a deformable portion adapted to engage the elongated member, and a crimping tool having an outer member and an inner member movably disposed within the outer member. The first anchor is inserted into a first section of tissue. The second anchor is threaded on the elongated member. Tension is applied on the elongated member to urge the first section of tissue toward a second section of tissue. The elongated member is threaded through the crimping device, and the inner member of the crimping device is moved with respect to the outer member thereby deforming the deformable portion of the second anchor and maintaining the tension applied to the elongated member.
One object of the invention is to provide an element for anchoring tissue.
Another object is to provide a system for delivering the tissue anchoring element.
A further object is to provide such a system that also tightens and ligates the anchoring element.
An additional object of the present invention is
Cole J. Dean
Justin Daniel F.
Haynes and Boone LLP
Jackson Gary
Orthodyne, Inc.
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