Surgery – Instruments – Suture or ligature
Reexamination Certificate
2000-02-04
2001-08-07
O'Connor, Cary E. (Department: 3732)
Surgery
Instruments
Suture or ligature
C606S215000, C606S230000
Reexamination Certificate
active
06270517
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 device having a central body member from which extend a plurality of lateral members with skin retention means, such as multiple barb members formed thereon or adhesive, which lateral members are pulled laterally into the two sides of a cut or incision to join the two sides of the cut together around the central body member.
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 consists of a central body member having first and second sides and first and second ends and having a plurality of 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 one another and perpendicular to the central body member. In one embodiment disposed on the outer end of each lateral member is a plurality of barb members, each of which extend therefrom at a rearwardly disposed acute angle to the direction of insertion. These lateral members, when inserted laterally into the skin or body tissue, 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 another embodiment adhesive can be used to hold the lateral members in position instead of, or in addition to, the barb members. In a further embodiment, in order to aid in inserting the lateral members, each lateral member can have its pointed end attached to a thread member extending to a needle member. To insert a lateral member, the needle member is manually inserted into the tissue in one side of the cut at an insertion point, pushed through the tissue a distance longer than the length of the lateral member and then directed out of the tissue at an exit point such that as the needle member pulls the thread member, it pulls the attached lateral member into the tissue where the barb members, if used, allow it to advance as they are rearwardly facing. When the lateral member has reached its desired position, the user ceases pulling on the needle member and thread member and cuts off the thread member at the exit point on the surface of the skin. This procedure is done for each lateral member until they are all in the desired position, closing the cut on each side around the central body member. If an adhesive coating is used instead of barb members, the needle and thread are held in position until the adhesive has bonded to the tissue. The structure of the suture assembly and thread members of this invention can be made of bioabsorbable material so that they will dissolve gradually as the cut or incision heals. Surgical adhesives based on collagen, fibrinogen or other thrombin/fibrinogen glue formulations can be used in various coating configurations with the suture assembly of this invention. When using adhesive coatings rather than barb members to retain the suture assembly in place, it should be noted that the adhesive formulations can be placed on the lateral members. When a lateral member with such adhesive coating is inserted into the body tissue, moisture on the tissue can have a solvating effect on the glue components which become mixed together as the lateral member passes through the tissue. In order to better retain the adhesive thereto, the suture surface can be modified by ion treatments or chemical surface activating agents. The lateral members can also be physically pitted or cratered to provide stronger bonding of the adhesive thereto to prevent the suture from unintentionally releasing its adhesion to the body tissue. The lateral members and central body member can have an extremely narrow diameter, yet be stiff enough to be pulled into the skin or other tissue to be joined. The structure material can not only be round, as illustrated, but also can be flat, oval or other cross-sectional shape including being hollow and containing material. The barb members can be disposed either in a plane parallel to the plane of the lateral members or, in an alternate embodiment, can be disposed not only parallelly but also perpendicularly to such plane or at other positions around the lateral members to provide for even greater retention of the suture assembly within the skin or body tissue into which the lateral me
Nitkin William
O'Connor Cary E.
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