Surgery – Instruments – Suturing needle
Reexamination Certificate
1997-07-02
2001-02-20
Brown, Michael A. (Department: 3764)
Surgery
Instruments
Suturing needle
C606S219000, C606S221000, C606S222000, C227S902000
Reexamination Certificate
active
06190401
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to the field of laparoscopic or endoscopic surgery, and more particularly to a device for advancing a surgical staple into torn tissue such as the meniscus of the knee for repairing the torn meniscus.
2. Discussion of the Prior Art
A technique has been developed using arthroscopic instruments which provides for meniscal repair through the use of a pair of surgical needles which are inserted through cannuli into the knee on opposite sides of the tear in the meniscus to be repaired. The needles are linked by a single suture which is pushed down through the cannuli and across the tear. An incision is made in the skin at the point where the needle exit the knee joint so that the leading end of each needle may be grasped and pulled through the joint. The ends of the sutures are then grasped after the needles are removed from the suture ends and the suture is then tied outside the skin so that a horizontal suture is created in the meniscus. This procedure is repeated for placement of as many suture as necessary to repair the meniscus tear. This process is very time consuming, and the strength of the repair is dependent upon the tension created by the knot tied in the suture.
An additional procedure and instrument is known from U.S. Pat. No. 5,002,562, in which a barbed clip and instrument for applying the clip for repairing peripheral meniscal tears is disclosed. The instrument has a pair of opposed arcuate jaws which are shaped to hold a complementary-shaped curved surgical clip therebetween, such that the barbs of the clip are retained within notches in the jaws until the clip is inserted. The legs of the clip are typically joined by a flexible material, such as a suture. The jaws are biased in a normally open position, and as the jaws are pushed into the tissue, the jaws are scissored or closed together until they preferably overlap to move the legs of the clip together until they cross. The jaws are then reopened and backed out of the tissue, with the barbs of the clip retaining the clip in position in the tissue.
However, a disadvantage of such a device lies in the fact that the scissoring or cutting action of the jaws necessary to move the legs of the clip together may further damage the surrounding meniscal tissue. Consequently, there remains a need for a tool for applying tacks or staples which avoids incidental damage to the tissue during insertion of the staple. The need exists for a device for repairing torn tissue, such as the meniscus of the knee, which obviates the disadvantages encountered in the prior art and provides an efficient, suture-type device which expedites the surgical procedure and reduces the amount of precision necessary on the part of the surgeon during the procedure.
SUMMARY OF THE INVENTION
It is therefore an aim of the present invention to provide a tool which avoids any incidental damage to surrounding tissue during repair of torn tissue, such as a procedure for repair of the meniscus. The present invention provides such a tool for linearly inserting a resorbable staple into the mensicus. In order to insert the staple linearly, the tool includes longitudinally movable shaft members, which are advanced longitudinally to advance the staple held at the distal ends of the shafts linearly into the meniscus. To accomplish longitudinal movement of the shaft members, a pair of squeezable handles are provided which are movable toward one another to move the shafts distally to advance the staple linearly into the meniscus. Means are provided for translating movement of the handles into the linear advancement of the shaft members, in the form of a rack and pawl mechanism, which translates the pivotal motion of the handles toward each other to longitudinal motion to move the shafts distally.
The tool of the present invention provides for sequential advancement of the staple member in that the legs are advanced one at a time. A first leg is advanced into position in the tissue, followed by advancement of the second leg so that the flexible material is positioned across the tear in the meniscus. After the first leg is positioned in the tissue, the pawl member associated with the first shaft member is disengaged from its rack member to terminate further advancement of the first leg. The second leg member is then advanced into the tissue so that the suture material is positioned across the tear. The tool further includes means for releasing the shaft members after insertion of the staple to return the shafts to their original position so that the tool may be withdrawn from the surgical site.
In a second embodiment, the device for repairing torn tissue and muscles of the present invention comprises a pair of surgical needles, each of which is engaged with one of a pair of anchoring leg members, which essentially comprise absorbable rods having outwardly projecting barbs. Each anchoring leg member is secured adjacent a second end opposite the penetration end to an absorbable flexible material such as a suture which extends between the two anchoring leg members. The means of engagement between the needles and anchoring leg members allows for a first pushing force applied axially to the needles in a first direction to be transmitted to the anchoring leg members to advance the anchoring members into the torn tissue, while allowing for the release of the needles responsive to a second pulling movement applied in an opposite direction to the pushing force. The means of engagement between the needles and anchoring members may be provided by a frictional engagement between a channel in each of the anchoring members and the needles.
The tool of the present invention thus reduces the incidental trauma to tissue caused during the insertion of a staple by providing for linear insertion of the staple. The tool expedites the surgical process by providing for quick loading of the staple and insuring accurate placement at the tissue tear.
The staple member for use with the tool of the present invention preferably includes a pair of anchoring leg members constructed with a plurality of outwardly directed barb members along their length. The material of which the leg members are formed is preferably a substantially rigid bioresorbable material which allows for penetration of the legs into the meniscal tissue. The barb members permit forward penetration but restrict or prevent reverse movement of the barbs, thereby preventing the legs from backing out of the tissue after placement. Preferably, the leg members are formed by injection molding techniques.
The leg members include a longitudinal slot or channel which accepts a needle member which is positioned at the distal end of each shaft member of the tool of the present invention. The leg members are loaded onto the needles for placement into the tissue, such that the needles penetrate the tissue so that the leg members may be driven behind the needles into position. Preferably, the leg members are joined at their rearward ends by a flexible material such as a suture. After the leg members are secured in the tissue, the needles, and the tool, are withdrawn leaving the leg members and suture anchored in the tissue.
The needles for use with the invention may have a uniform cross section, with one of the needles being positioned in each channel. In order to provide a suitable engagement therebetween, each channel maybe provided with a narrower uniform cross section suitable to provide a frictional engagement with the needle so that a first pushing force applied axially to the needles is transmitted to the anchoring members to advance the anchoring members into the torn tissue, while a second pulling force applied in the opposite direction to the pushing force releases the needles from their engagement with the anchoring members.
With other embodiments, the needles may similarly have a uniform cross section, and each channel may taper or narrow to a suitable diameter less than the diameter of the needles. The needles may instead be tapered in the directio
Geiste Robert J.
Green David T.
Person Wayne C.
Brown Michael A.
Koo Benjamin K.
United States Surgical Corporation
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