Surgery – Instruments – Suture retaining means
Reexamination Certificate
1998-03-02
2001-11-20
Reip, David O. (Department: 3731)
Surgery
Instruments
Suture retaining means
C606S075000, C411S054000
Reexamination Certificate
active
06319269
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to fixation devices, and in particular, fixating devices for insertion into bores in materials to allow the connection of another element to the material in which the fixation is disposed. In particular, the present invention relates to a fixation device for the medical field, which can be inserted into, for example, a pre-drilled bore in bone, to allow the connection to the bone of another member, for example, a prosthetic member. Alternatively, the fixation device can have sutures attached that allow the suturing of another member to the fixation device. As an example, the fixation device of the present invention may have sutures attached thereto which allow the securement of a prosthetic device or artificial member, or a natural anatomical member, for example, ligaments, to the bone.
Although the present invention has particular application in the medical field, it is not limited thereto and may find other uses, i.e., wherever it is necessary to fasten two or more members together, especially when the members are to be secured together with fixation devices located in bore holes that are blind or open to only one side, i.e., not completely drilled through.
U.S. Pat. No. 5,268,001 to Nicholson et al. relates to a bone fastener for fixing either a suture or a rivet within a pre-drilled bone hole. In the device of that reference, the bone fastener includes an expandable sleeve having an axial bore and a pin which is forcibly insertable into the axial bore. The expandable sleeve is configured to be insertable into the bore drilled in the bone and at least a portion of the pin has an outer diameter greater than the inner diameter of at least a portion of the axial bore of the sleeve. The fastener is emplaced by inserting the sleeve into a pre-drilled hole in the bone and then forcing the pin into the axial bore of the sleeve, so that the wider portion of the pin presses outwardly against and expands the narrow portion of the sleeve, causing the sleeve to forcibly contact the walls of the bone hole and fixing the pin and sleeve firmly in place within the hole. The apparatus for emplacement of the fastener includes a holder for holding the expandable sleeve in position within the pre-drilled hole in the bone and a plunger moveable in relation to the holder for forcing the pin into the bore of the sleeve so that the pin can be forced in the axial bore without imposing substantial force toward or away from the bone. The device includes a severable attachment between the holder and the expandable sleeve which is cut by a cutting edge of a cylindrical blade. The sleeve is thereby separated from the holder body and the fully expanded and fixed fastener is freed from the insertion apparatus.
The device of the Nicholson et al. reference has several drawbacks including that a force must be applied toward the bone or member in which the fastener is being inserted. This causes greater strains than necessary to the patient because the anchor must be expanded by this pushing force, which causes undue strain on the material of the member in which the fastener is being inserted. The expandable sleeve also may not provide sufficient engaging force to secure the fastener in the bore hole in the bone because it only expands and frictionally engages in the bone without actually cutting or penetrating into the bone. Additionally, the cutting edge necessary to separate the fastener sleeve from the holder body creates additional complexity.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a fixating device.
It is yet still a further object of the present invention to provide such a fixating or fastening device which is suitable for insertion into a pre-drilled hole in a material, e.g., bone.
It is yet still a further object of the present invention to provide such a fixation or fastening device which can be used to fasten one element to another element in which the fixation or fastener device is inserted.
It is yet still a further object of the present invention to provide a fixation or fastening device which can be inserted into a material, for example, bone, to allow the connection of another member, for example, a prosthesis, or which has sutures coupled thereto for the connection of another body part, for example, ligaments, to the bone.
It is yet still a further object of the present invention to provide a fixating or fastening device which is relatively simple and convenient to use, and furthermore, which is simple to manufacture.
It is yet still a further object of the present invention to provide a fixation or fastening device which avoids the need for complicated cutting mechanisms to sever the fixation or fastening device from its insertion apparatus.
It is yet still another object of the present invention to provide an apparatus for inserting a fixation or fastener device into a pre-drilled hole in a member, for example, bone.
It is yet still a further object of the present invention to provide an apparatus for inserting a fixation or fastening device of the type generally disclosed in applicant's co-pending application Ser. No. 08/294,067 filed Aug. 22, 1994.
It is yet still another object of the invention to provide a fixation device that is conveniently loaded into its insertion apparatus.
The above and other objects of the present invention are achieved by an apparatus for inserting a fixation device securely into a bore in an element comprising a hand held device having an actuating mechanism; a longitudinally extending member coupled to the hand held device adapted to hold the fixation device at a distal end; the fixation device having a plurality of engaging members adapted to be moved outwardly when the fixation device is inserted into the bore to secure the fixation device in the bore; the extending member having an operating member coupled to the fixation device for exerting a force on the fixation device to cause the engaging members to extend outwardly to engage the wall of the bore; and the operating member being releasably coupled to the fixation device.
The objects of the present invention are furthermore achieved by a fixation device assembly for engagement by an insertion tool for inserting the fixation device assembly into a bore in a member, the assembly comprising a first member having a plurality of engaging members, the engaging members being adapted to be engaged by a cam surface to cause the engaging members to move outwardly to engage the bore in response to actuation by said insertion tool; and a second member extending longitudinally from the first member adapted to have a force releasably exerted thereon for causing the engaging members of the first member to engage the cam surface and move outwardly.
The objects of the invention are also achieved by a method for inserting a fixation device securely into a bore in an element comprising providing a hand held device having an actuating mechanism; inserting a fixation device into a longitudinally extending member of the hand held device at a distal end, the fixation device having a plurality of engaging members adapted to be moved outwardly when the fixation device is inserted into the bore to secure the fixation device in the bore; exerting a force on the fixation device with the actuating mechanism to cause the engaging members to extend outwardly to engage the wall of the bore; and releasing the fixation device from the longitudinally extending member.
Other objects, features and advantages of the present invention will become apparent from the detailed description which follows.
REFERENCES:
patent: 5643321 (1997-07-01), McDevitt
patent: 5649963 (1997-07-01), McDevitt
patent: 5713903 (1998-02-01), Snader et al.
patent: 5797963 (1998-08-01), McDevitt
Ostrolenk Faber Gerb & Soffen, LLP
Reip David O.
Woo Julian W.
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