Surgery – Instruments – Suture – ligature – elastic band or clip applier
Reexamination Certificate
2001-03-27
2003-03-04
Worrell, Danny (Department: 3731)
Surgery
Instruments
Suture, ligature, elastic band or clip applier
Reexamination Certificate
active
06527785
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to medical suturing instruments and more particularly to drive means in such instruments for advancing a suture strand through tissue, and the like.
BACKGROUND OF THE INVENTION
Suturing instruments are typically used to draw together two or more portions of a subject patient (e.g., tissue such as muscle or skin) or to attach an object to the patient (e.g., to attach a piece of surgical mesh to the abdominal wall of the patient during hernia repair surgery).
Certain suturing instruments employ a needle that precedes a length of suture material through a subject.
For example, U.S. Pat. Nos. 3,470,875; 4,027,608; 4,747,358; 5,308,353; 5,674,230; 5,690,653; 5,759,188; and U.S. Pat. No. 5,766,186 generally disclose suturing instruments in which a needle, with trailing suture material, is passed through a subject.
U.S. Pat. Nos. 4,890,615; 4,935,027; 5,417,700; and No. 5,728,112 generally disclose suturing instruments in which suture material is passed through the end of a hollow needle after that needle has passed through a subject.
With all of the foregoing devices, a needle must be passed through the subject in order to deploy the suture. This is generally undesirable, since the needle typically leaves a larger hole in the subject than is necessary to accommodate only the suture material. In this respect it should be appreciated that it is generally desirable to alter each portion of the material being sutured as little as possible.
A suturing instrument has been devised which permits the suture material itself to pierce the subject without the use of a needle. However, this device does not permit sufficient flexibility with regard to the amount of tension that may be applied to the suture and tissue.
More particularly, U.S. Pat. No. 5,499,990 discloses a suturing instrument in which a 0.25 mm stainless steel suturing wire is advanced to the distal end of a suturing instrument, whereupon the distal end of the suturing wire is caused to travel in a spiral direction so as to effect stitches joining together two portions of a subject. After the spiral is formed, the beginning and end portions of the suture may be bent toward the tissue in order to inhibit retraction of the suture wire into the tissue upon removal of the suturing instrument. The stainless steel wire is sufficiently firm to hold this locking set. In addition, after the spiral is formed, the radius of the deployed suture spiral may then be decreased by advancing an outer tube over a portion of the distal end of the instrument. Again, the stainless steel wire is sufficiently firm to hold this reducing set.
Unfortunately, however, such a system does not permit sufficient flexibility in all situations with regard to the appropriate amount of tension to be applied to the subject, since the wire is relatively firm (i.e., firm enough to hold its sets). Such a system also does not provide sufficient flexibility with regard to the appropriate type of suture stitch to be applied, since the device is specifically configured to provide only a spiral suture stitch.
In contrast to the aforementioned limitations of the suturing instrument of U.S. Pat. No. 5,499,990, it is desirable that a suturing instrument approximate the portions of the material which is to be joined in the correct physiological relationship, and to urge the portions together with an appropriate amount of force. If too much force (or tension) is applied to the suture material, then the subject portions may become necrotic or the sutures may cut through the subject. If too little tension is applied to the suture material, then the healing process may be impaired.
U.S. Pat. No. 4,453,661 discloses a surgical instrument for applying staples. The staples are formed from the distal end of a length of wire. The distal end of the wire is passed through a subject, and thereafter contacts a die that causes the wire to bend, thereby forming the staple. The wire is sufficiently firm to take the set imposed by the die. The staple portion is then cut from the wire by a knife. Again, such a system suffers from the fact that it does not permit sufficient flexibility in all situations with regard to the appropriate tension to be applied to the subject, since the attachment is made by a staple which has a predefined geometry and is formed with relatively firm wire. In addition, the system is limited as to the type of fastening which may be applied, since the surgical instrument is limited to only applying wire staples.
There is a need, therefore, for a new suturing device that permits minimally disruptive suturing and permits flexibility in the placement, application, and tensioning of the suture material.
SUMMARY OF THE INVENTION
The invention provides a device for introducing a flexible elongated element through a subject. In one embodiment, the device includes a proximal end and a distal end, as well as an advancement unit for longitudinally advancing the flexible elongated element toward the distal end of the device such that a distal end of the flexible elongated element may pass from the distal end of the device with sufficient force to pass through the subject. The device also includes a securing unit for variably adjusting a securing force applied by the flexible elongated element so as to provide the desired securement to the subject.
In further embodiments, the device includes a guide tube for guiding the flexible elongated element through the device, toward the distal end of the device, as well as a rotation unit for rotating the distal end of the device so as to cause the flexible elongated element to wrap around itself, whereby to adjustably apply the securing force to the flexible elongated element.
In still further embodiments, the device includes means for directing the flexible elongated element out of the distal end of the device in a manner causing the element to loop, or coil, through tissue to attach one tissue portion to another, or attach a portion of the element to a selected tissue.
In yet further embodiments, the invention provides a tool for joining a first layer of material to a second layer of material, said tool comprising: a handle; an end effector mounted on said handle and defining therein: a first channel for retaining a wire guide; a second channel extending from the first channel for supporting a suture wire extending from the wire guide; a passageway for retaining a cutter bar; and an end recess; said second channel being curved to impart a looping configuration to portions of the suture wire passed therethrough; and said end recess having a curved surface at a bottom of said end recess, such that the end recess is adapted to receive the looped suture wire emerged from said second channel; a wire advancing actuator mounted on said handle for moving the suture wire through said second channel and through the material first and second layers; and a wire cutting actuator mounted on said handle for moving the cutting bar into cutting engagement with the suture wire.
And in still further embodiments, the invention provides a tool for joining a first layer of material to a second layer of material, said tool comprising: a handle; an end effector mounted on said handle and comprising: a first fixed portion defining therein a first groove defining a portion of a first channel for retaining a wire guide; a second channel extending from the first channel for supporting a suture wire extending from the wire guide; a portion of a passageway for retaining a cutting bar; and wall structure defining a portion of an end recess in a distal end of said end effector; and a second fixed portion defining therein a first groove defining a remainder of the first channel; a second groove defining a remainder of said passageway; a wall portion defining a remainder of said second channel; and a sidewall for defining a remainder of the end recess; said second channel being curved to impart a looping configuration to portions of the suture wire passed therethrough; the end recess being defined in part by a curved surface in
Field Frederic P.
Fogg Douglas A.
Guyer Brett
Rice John T.
Sancoff Gregory E.
Onux Medical, Inc.
Pandiscio & Pandiscio P.C.
Worrell Danny
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