Since their first introduction on the U.S. market, tissue adhesives have been gaining acceptance in the operating room as an attractive alternative to the use of sutures for closing skin lacerations. This technology takes less time to apply and causes less pain than suturing, and requires no dressing or needle use. This is especially useful in the case of children, or when small-caliber sutures must be removed from sensitive areas of the face. In addition, the risk of needle-stick injury and transmissible infections for operating room personnel is removed.
Surgical adhesives such as cyanoacrylate glues have the advantage that they are generally easy to dispense. However, application of adhesives during any surgical procedure can be cumbersome. Because of their liquid nature, these adhesives are difficult to precisely position on tissue and thus require adept and delicate application if precise positioning is desired. Cyanoacrylates also harden rapidly; therefore, the time available to the surgeon for proper tissue alignment is limited.
Improvements to currently available biologic and synthetic adhesives are addressed in a co-pending U.S. patent application: Non-Light Activated Biological Adhesive Device, System, and Methods of Use Thereof, Ser. No. 10/610,068, filed June 2003 (to co-inventors McNally-Heintzelman K M, Heintzelman D L, Bloom J N and Duffy M T). The present application describes locking wound closure clamps designed to facilitate the use of the adhesive described in the above mentioned U.S. patent application, as well as other surgical adhesives and adhesive-enhanced repair techniques.
One aspect of the present invention relates to a locking wound closure apparatus, system and method for placing wound edges in close apposition to allow for a proper closure. In accordance with the present invention, a wound closure apparatus is provided, which includes first and second clamp arms coupled together at one end. Each clamp arm includes a blade. Each blade includes a gripping surface. The blades on the clamp are separated by a well for placement of an adhesive material. The clamp is configured to isolate the wound field and align the wound edges to allow for precise placement of the adhesive material.
Another aspect of the present invention relates to a locking mechanism that allows a single user to both clamp and set an adhesive material in place. Thus, in an alternative embodiment, the wound closure apparatus further includes a locking mechanism. In the illustrated embodiment, the locking mechanism includes a pair of spaced apart locking members configured to engage one another. In the illustrated embodiment, a first locking member is coupled to the first clamp arm and a second locking member is coupled to the second clamp arm. In certain embodiments, the locking mechanism has a variable width to allow for customized selection of the size of the adhesive material.
Yet another aspect of the present invention relates to a plurality of interchangeable blades, manufactured, for example, with variable length and weight, to suit a broad range of wound closures. Accordingly, a wound closure system is also provided, which includes a wound closure apparatus and a plurality of blades.
Still another aspect of the present invention involves a separate instrument to provide custom curvilinear bending of the blades such that they can be contoured to suit non-linear wounds. Accordingly, an alternative wound closure system is provided, which includes a wound closure apparatus and a blade adjustment apparatus.
A further aspect of the present invention relates to a locking wound closure apparatus configured to facilitate closure of higher tension wounds. In one embodiment, the clamp of the wound closure apparatus has a heavier weight. In another embodiment, the blades include dentals or dental-like protrusions configured to engage thicker skin and/or skin under high tension.
a is a perspective view of an embodiment of a wound closure apparatus used to place wound edges in close apposition for proper closure;
b is a side view of a first embodiment of a blade and gripping portion for use with the wound closure apparatus of
c is a side view of a second embodiment of a blade and gripping portion for use with the wound closure apparatus of
d is a top view of the apparatus of
e is a side view of a third embodiment of a blade and gripping portion for use with the apparatus of
f is a top view of the apparatus of
a is a perspective view of a first alternative embodiment of a wound closure apparatus used to facilitate closure of high tension wounds;
b is a perspective view of a second alternative embodiment of a wound closure apparatus used to facilitate closure of high tension wounds;
c is a perspective view of a third embodiment of a wound closure apparatus used to facilitate closure of high tension wounds;
d is a top view of the blades of the apparatus of
e is a side view of the blade shown in
a-1f show various features and alternative designs of portions of a wound closure apparatus in accordance with the present invention.
The wound closure apparatus 100 of
The various portions of wound closure apparatus 100 are made of surgical steel or other suitable material known in the art. Portions of clamp arms 102, 104 may be coated or enclosed in a synthetic material such as a foam, rubber or other suitable high-friction material to provide for easier maintenance and handling by the medical professional.
Locking mechanism 106 operates to hold blades 116, 118 in place after application to a wound area. In particular, locking mechanism 106 allows the medical professional to remove his/her hand from wound closure apparatus 100 after a wound has been closed, so that the hand is free to apply an adhesive to the wound site or perform other tasks.
First locking member 108 includes at least one coupling portion 112, e.g., gradation, ridge, hook, or the like that is sized to mate with a corresponding coupling portion (not shown), e.g., depressions, catches, rings, or the like of second locking member 110. It is understood that any suitable coupling mechanism known in the art may be used to couple locking members 108, 110 together.
In addition, locking members 108, 110 preferably include at least two such coupling mechanisms, so that wound closure apparatus 100 is adjustable to wounds of varying widths or thicknesses.
d shows an example of wound closure apparatus 100 in a locked position, holding a wound closed with the wound edges aligned. Through the use of an adjustable locking mechanism 106 and various alternative blades 116, 118, the amount of force or tension exerted on the wound site can be controlled and adjusted to achieve the desired alignment of the wound edges.
As noted above, blades 116, 118 are configured with a gripping portion 122. The characteristics of the gripping portion are selected as appropriate based on the type, size, or location of the wound, the type of adhesive or method of wound closure being used, or other criteria.
b shows one variation of a gripping portion. Interior surface 128 of at least one of blades 116, 118 has an irregular character, for example, including alternating raised areas (shown as shaded squares) and flat or depressed areas (unshaded squares). Protrusions 130 are coupled to outer surface 124 of blades 116, 118 by solder, adhesive or other coupling means, or are molded with each blade 116, 118. As shown in
c shows another variation of gripping portion 122, including bumps 132 coupled thereto in an alternating pattern to provide an irregular surface. Bumps 132 are coupled to gripping portion 122 via any suitable coupling means mentioned above or otherwise known in the art, or are molded into gripping portion 122 by known techniques. Protrusions 134 generally have a smaller diameter or thickness than the protrusions 130 shown in
In the alternative design of
a,
2
b, and 2c show alternative embodiments of a wound closure apparatus 200 in accordance with the present invention.
As shown in
In the embodiment of
The inner surfaces of end portions 216, 218 and center portion 214, i.e., the surfaces facing toward the gripping surface of the opposite clamp arm, are illustratively smooth. However, it is understood that one or more of such inner surfaces may have an irregular or rough character. For example,
End portions 216, 218 are configured to form a “well” around the wound when apparatus 200 is in use. The well is designed to hold a volume of adhesive in the area of the wound.
The embodiment of
The alternative gripping mechanism of
Adjustment member 226 includes a curved portion 232 which controls movement of reverse action grips 224. When pressure is applied to adjustment member 226 in the direction of arrow 236, reverse action grips 224 move in the corresponding direction of arrow 234. For example, if adjustment member 226 is moved downwardly toward blades 210, 212, reverse action grips 224 will move downwardly away from blades 210, 212, thus creating a gap between grips 224 and blades 210, 212. If adjustment member 226 is moved upwardly toward end 220, reverse action grips 224 move upwardly toward blade portions 210, 212, thus closing the gap between grips 224 and blades 210, 212. Operation of adjustment member 226 can be performed independently of locking mechanism 206, 208. In the illustrated embodiment, adjustment member 226 controls the action of both grips 224 simultaneously. In an alternative embodiment, grips 224 are independently controllable.
In the illustrated embodiment, cross member 228 is sufficiently flexible or resilient so that when clamp arms 202, 204 move toward or away from each other (e.g., to engage locking mechanism 206, 208), cross member 228 flexes inwardly or outwardly as needed.
In
d shows the embodiment of
Although the present invention has been described in detail with reference to certain exemplary embodiments, it is understood that variations and modifications exist and are within the scope and spirit of the present invention.
Number | Date | Country | |
---|---|---|---|
60526819 | Dec 2003 | US |