Surgery – Instruments – Suture or ligature
Reexamination Certificate
2000-02-04
2001-07-24
Jackson, Gary (Department: 3731)
Surgery
Instruments
Suture or ligature
C606S224000, C606S216000, C606S223000
Reexamination Certificate
active
06264675
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The device of this invention resides in the area of sutures and fasteners for closing the two sides of an incision or cut in human skin or other body tissue and more particularly relates to a suture having adhesive thereon in some embodiments with a stop member and in other embodiments being a device having a central body member from which extend lateral members, each with body tissue retention means thereon such as barbs and/or adhesive, which lateral members are pulled laterally through a cut to join the two sides of the cut together.
2. Description of the Prior Art
Sutures for closing incisions or wounds are well known in the prior art. Such sutures or ligatures are often attached to the shank end of a needle and are utilized by physicians to make stitches to close incisions or wounds so that they may heal. Sutures are formed not only of threadlike material, but are also available as a one-piece unit combined with a needle. Sutures are available in a wide variety of monofilament and braided suture material. Sutures can be formed of non-absorbable material such as cat gut, silk, nylon, polyester, polypropylene, linen, or cotton as well as bioabsorbable synthetic material such as polymers and copolymers of glycolic and lactic acid. Germicides can also be incorporated into the structure or sutures which can be retained by the suture substrate to provide long-lasting germicidal properties.
Also known in the prior art are fasteners which eliminate the need for sutures in many instances. These fasteners are commonly referred to as “staples” and are useful in joining tissue layers laterally, for example, closing wounds in skin or fascia. Such staples are dispensed by implanting devices loaded with such surgical fasteners, the use of which devices can accomplish in very short time what would take many minutes to perform by suturing. Some staples can be made of bioabsorbable materials. The use of such fasteners results in a significantly reduced loss of blood and also lowers the level of trauma to the patient. Such staples can be in the form of metal staples which have arms bent by the fastening device to hook the separated body tissue together. Staples can require the stapling apparatus to have an anvil member which must be positioned under the tissue to be stapled so that the arms of the staple can be bent inwards. Two-part fastening devices also have been used which incorporate a barbed staple, the arms of which are attached to a bottom retaining member. One drawback to employing staples requiring that a retainer member be attached to it is that there must be means for positioning such retainer member under the body tissue to be joined, and one must have access to the body tissue both from above and below the body tissue. Metal staples applied to the body must also be removed by staple extractors.
Other types of surgical fasteners include skin tacks which are used to join two sides of an incision. Such skin tacks include a barbed tip on each end of the inverted U-shaped tack, the body of which is transversely positioned across an incision or cut and the tack applied so that the barbed tips engage straight downward into the skin to hold each side of the adjacent layers of body tissue together. More recently “zippers” have been applied on each side of an incision which allow for reopening, if desired.
Applicant has invented a suture assembly having a central body member with a plurality of elongated lateral members extending from the central body member from each side thereof, each such lateral member having a plurality of barbs thereon to retain the lateral members securely in the body tissue, as described in U.S. Pat. No. 5,425,747. Applicant further developed a method of lateral member insertion utilizing shaft-like, removable insertion members which can push each lateral member into position in the tissue and which insertion member can then be removed, as described in Applicant's U.S. Pat. No. 5,584,859.
SUMMARY OF THE INVENTION
It is an object of this invention to provide an improved surgical fastener for joining skin or other body tissue such as separated by a cut or an incision.
The structure of this invention in one embodiment consists of a suture of a thread material having a needle member disposed at one end and adhesive disposed along such suture in a manner so that when drawn into body tissue, the adhesive becomes activated. In use one would insert the needle member on the surface of the skin at an entry point adjacent to the cut to be closed on the first side of the cut and draw the suture material, such as a thread member, through the body tissue and out through the first inside of the cut and then into the second inside of the cut and then up through the body tissue of the second side and then out an exit point on the surface of the second side of the cut. One would draw the needle member and attached suture thread member, pulling the portion of the thread member carrying the body-activated adhesive into the body tissue on both sides of the cut. A stop member can be inserted on the thread member which, when striking the body surface on the first side of the cut, stops the advancement of the thread member and requires further pulling of the needle member to pull the sides of the cut together while at the same time the adhesive is solvated by moisture in the body tissue and becomes active, thereby retaining the body tissue to the suture and holding the cut together. The ends of the suture thread member at the stop member and at the needle member end can be cut off once the suture has brought the two sides of the cut together. Multiple levels of sutures can be used to close deep cuts with one level of suture being above the adjacent level. In some embodiments the adhesive can have a dissolving coating. The adhesive can be a mixture activated by solvation caused by moisture within the body tissue or the adhesive can be a plurality of alternate segments of adhesive which, when mixed by solvation and pulled through the body tissue, become activated. In another embodiment the invention can consist of a central body member having first and second lateral members attached thereto, such lateral members having an inner end, an outer end, and a length and being disposed in one embodiment in the same plane parallel to and aligned with one another. In one embodiment of the invention a plurality of barb members each extends from the first lateral member at a rearwardly disposed acute angle to the central body member. Such lateral member, when inserted laterally into the skin or body tissue, can remain fixed in position because the barb members, if the skin or body tissue is moved in a direction away from the central body member, will catch the skin or body tissue and prevent such outward movement. In addition, adhesive can be used to hold the second lateral member in position along with, in some embodiments, a stop member, as described above, or adhesive can be used on both lateral members in place of the barb members. The first lateral member has a generally pointed end attached to a thread member extending to a needle member. To insert such lateral member, the needle member is manually inserted into the body tissue in one side of the cut at an insertion point, pushed through the body tissue across the cut into the body tissue in the other side of the cut and then directed out of the body tissue at an exit point such that as the needle member pulls the thread member, it pulls the attached lateral member into the body tissue where the barb members, if used, allow it to advance as the barb members are rearwardly facing. When the lateral member has reached its desired position with the central body member substantially aligned with the length of the cut, the user ceases pulling on the needle member and attached thread member and cuts off the thread member at the exit point on the surface of the skin. This procedure is carried out for each suture. If adhesive is used instead of barb members, the needle and thread are held in
Jackson Gary
Nitkin William
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