US3525340A - Surgical dressing with skin clips thereon - Google Patents

Description

United States Patent Joseph G. Gilbert 75 Barberry Lane, E. Hills. Roslyn Heights. New York 11577 [21 1 Appl No. 679,365

[22] Filed Oct. 31, 1967 [45] Patented Aug. 25, 1970 [72] Inventor [54] SURGICAL DRESSING WITH SKIN CLIPS THEREON 2 Claims, 3 Drawing Figs.

[52] US. Cl 128/337, 128/155 [51] Int. Cl A6lb 17/08 501 Field ofSearch 128/334.

FOREIGN PATENTS 23818 1914 Great Britain 128/334 421306 2/1911 France 128/155 464,802 7/1951 Italy 128/337 Primary Examiner- Dalton L. Truluck Attorney-Watson, Leavenworth and Kelton ABSTRACT: A surgical dressing is disclosed in which one side of a relatively thin, elastic and flexible substrate, such as of foam rubber is provided with surgical clips for simplified inscrtion thereof through the substrate into skin, for coaptation of edges of lacerations. This can be accomplished by simple manual pressure upon the clips. The substrate simultaneously serves as a means for mounting and for permitting simple insertion of clips. and also provides a dressing for the wound. Optionally, the side of the substrate which faces the wound can be provided with an adhesive coating constituted either of a conventional adhesive, or of a novel, pharmacologically active adhesive coating comprising a solution or residue of solution of 0.5 21 percent by weight, solids basis, of tannic acid, 0.5-5 percent cinnamic alcohol. with the balance of solids being polyvinylpyrrolidone. The novel composition can be employed in conjunction with substrates without the provision of surgical clips.

Patented Aug. 25, 1910 3,525,340

SURGICAL DRESSING WITII SKIN CLIPS THEREON The present invention relates to a surgical implement, more particularly a surgical dressing and method for making the same.

A large variety of materials and implements are known for the treatment of wounds in mammalian skin. Among these are a variety of disinfectant formulations with greater or lesser degree of astringency. There are, however, no materials available which in all respects satisfactorily will stop bleeding and will establish for the prolonged periods necessary for healing the antibacterial circumstances desirable for preventing infection and reinfection of the wound.

Surgical dressings have been used with or without additional mechanical devices in the treatment and protection of lacerations in animal tissue. In the case of smaller wounds, sufficient coaptation of the edges of the wound can be normally achieved by surgical dressings alone. In many cases, especially in cases of wider, gaping wounds mechanical devices such as clips and/or sutures have been used. A principal drawback of such mechanical devices resides in their unsuitability for employment in first-aid applications when no trained personnel is present. Even when the required expertise is available, the use of such mechanical means is often insufficient for controlling bleeding. In the prior art surgical clips are individually removed from a wire mounting by a special type of forceps called the Michel applicator. Subsequently a clip in the forceps is transferred to the place of application and forced into the skin by increasing the pressure by squeezing of the applicator. This procedure is repeated for each clip, and the number of clips is determined by the shape and size of the wound. The clips are then covered with gauze or the like dressing. A variety of problems make the application of clips difficult, time consuming and cumbersome. The Michel applicator has to be accurately positioned for gripping a clip in the removal thereof from its mounting frame and in the squeezing of the clip into the skin. The first operation is generally carried out by an assistant, and then the clip with applicator is handed over to the person inserting the clip, while retaining sufficient pressure on the clip to retain it in the applicator. This maneuver often results in a premature squeezing of the applicator and closure of the clip, or in dropping the clip frpm the applicat r w,

Wounds require periodic topical treatment, most usually to create from time to time the antiseptic conditions necessary for healing and the like. This necessitates removal of the dressing, and after treatment, the application of new dressing. Application of dressings requires considerable skill acquired by training and/or experience. It is often impossible to apply adhesive-type dressings of the prior art over hairy or curved body surfaces, bony joints and the like to stay in place for a sufficient length of time. Certain forms of dressing, such as in the form of rolled-up gauze, often results in an applied dressing having substantial bulk and low serviceability.

In accordance with the present invention a surgical implement is provided which comprises an elastic and flexible substrate and at least one clip attached thereto. The invention further comprises a coating for a surgical dressing, of a solution or residue of solution, of O.5-2O percent by weight, solids basis, of tannic acid (TA), 0.55 percent by weight, solids basis, of cinnamic alcohol (CA), and the balance of solids being polyvinylpyrrolidone (PVP). This coating can be applied to an elastic and flexible substrate with or without a clip being also disposed on the substrate.

One principal feature of the present invention is the discovery that the composition of the aforesaid coating which can be easily prepared from relatively inexpensive materials, possesses a surprising combination of beneficial attributes. The composition is soluble in water as well as in other liquids likely to exude from wounds or from mucous membranes. When partially or completely dissolved, the solution exhibits high degree of tackiness and creates a strong bond, even after evaporation or absorption of the solvent. Adherence characteristics of the solution to mammalian skin and to wounds, are further improved by the fact that the melting point of CA is slightly below normal body temperature, and consequently, the composition is at least moderately tacky at average body temperature. The coating composition of the present invention is available for immediate pharmacological action to control bleeding. and possesses broad-spectrum antibacterial characteristics, as well as acts as a repository of additional amounts of pharmacologically active material which will automatically become available upon either secondary bleeding or oozing or upon the appearance of any other endogenous or exogenous liquids or bacteria which would come into contact with the coating. The partial melting which occurs at body temperature, furthermore. makes small amounts of the pharmacologically active material constantly available for establishing the desirably active conditions at the skin surface. The remarkable adhesive characteristics of the pharmacological active composition allow its application to hairy areas of the body and to bony projections or moving joints without any further adhesives or gauze dressings. A coating composition in accordance with the present invention is remarkably stable and retains its characteristics for practically indefinite periods of time.

Another principal feature of the present invention is a surgical implement in which clips, such as the well known Michel clips are attached to an elastic and flexible substrate. Attachment of the clips to the substrate, at a time in advance of use, allows the simple use of the inventive implement, even by inexperienced and by untrained personnel, for coaptation of the edges of even gaping wounds and control of bleeding, regardless of the shape and size of the wound, even by simple manual pressure, such as can be applied by thumb and index finger. The substrate can be either manufactured in standard sizes, or can be simply cut with a scissor to desired size and shape for any desired wound configuration. The elasticity and flexibility of the substrate, furthermore, allows the stretching and bending of the substrate to adapt the implement to any requirement which may be occasioned by the shape of the surface and wound to be treated.

A flexible and elastic substrate with a clip can be also provided with a coating in accordance with the present invention, whereby the remarkable adhesive characteristics of the pharmacologically active coating or of a pharmacologically inactive prior art adhesive coating can be combined with the mechanical action of the clip to cooperatively create a very strong coaptation of even extremely gaping wounds. With or without use of an adhesive layer the combination of clips with a flexible, elastic substrate obviates the need for additional dressing, such as gauze and the like.

The present invention is disclosed in greater detail, with reference being had to the accompanying drawing, wherein:

FIG. 1 is a plan view of a 3-segment dressing in accordance with the present invention, showing various embodiments of the implement of the present invention;

FIG. 2 is a cross-sectional view taken along the line 22 of FIG. 1; and

FIG. 3 is a plan view of another embodiment of the invention.

In FIG. I there is shown a surgical implement or dressing 1 in accordance with the present invention, comprised of individual segments 2, 4 and 6. The segment 2 includes a thin foam rubber substrate 8. A spline 9 is arranged longitudinally along the top surface of the substrate 8 and Michel clips 10 are inserted into the substrate at spaced intervals over the spline. The spline can be of a soft steel wire preferably encased in a paper or plastic envelope, and serves, as shown in the drawing, to maintain the substrate in an upwardly curved position. As the clips are individually or in groups inserted into the skin, and the edges of the wound are being drawn together, the substrate is progressively bent downwardly with the spline. During the progressive flattening of the substrate and straightening of the spline, still to-be-applied portions remain curved away from the surface, thereby permitting visual control to facilitate accurate placement of the segment and the locating of the clips to follow the actual shape of a wound. If any adjustment is required, the flexible and elastic substrate can be shifted to accommodate irregularly shaped wound lines. The feature of using a spline is particularly advantageous when 3 or more clips are employed. Clips are shown already inserted, and clips 11 are shown as being about to be inserted.

The substrate 8 is ofelongated shape and is formed with convex and concave curved ends respectively. The segments 2, 4

and 6 are adapted to be placed end to end with respect to each other, the longitudinal axis of each segment being disposed at an angle relative to axis of an adjoining segment. In this manner the surgical implement I can be adapted to any irregularly shaped wound; for example, in the case of the embodiment shown in FIG. 1, an Sshaped wound. In the case of a straight-line wound that is longer than any individual segment, the adjacent segments can be substantially in alignment with each other. The alternating convex and concave ends of adjoining segments enable substantially complete coverage of the wound along its entire length, making it possible to utilize a single segment standardized as to size and shape for the dressing of wounds of most possible shapes and sizes. The substrate 8 is shown without the provision of any adhesive layer.

The segment 4 is constituted of a foam rubber substrate 12, of the same size and shape as the substrate 8. Clamps 14 are loosely inserted into the substrate and are ready for use. In the cross-sectional view of FIG. 2 the prongs 15 of a clip are shown in position prior to application. Wires 16 are the usual wires constituting the frame on which the Michel clips are strung and from which they are removed in the prior art practice, immediately prior to use. In the case of this embodiment of the present invention the wires are suitably left in place, permitting thereby the simultaneous attachment of a plurality of clips to the substrate, as well as the substantially simultaneous insertion of a plurality of clips when the implement 1 is applied.

The segment 6 is similar in all respects to segment 4, in that it is constituted of a substrate 18 with clips 20 being inserted therein. In FIG. I. the segment 6 is shown already applied to a skin surface, with the Michel clips 20 being already squeezed together and positioned in a skin surface (not shown).

The segments 4 and 6 are provided with an adhesive coating 22 on the respective surfaces of the substrates opposite to those through which the clips are inserted.

The embodiment of the present invention shown in FIG. 3 comprises a spongelike substrate 24, and a pharmacologically active adhesive layer 26 of the present invention applied thereover. The adhesive layer is discontinuously applied, with apertures 28 distributed throughout the adhesive layer. The apertures 28 permit direct communication between a bleeding or otherwise secreting laceration and the spongelike substrate 24. This embodiment is particularly useful as a pharmacologically active temporary dressing, for example for employment in cases of long wounds or in cases of a multiplicity of lacerations, simultaneously to provide a means for blotting up or sponging larger volumes of blood or other secretions, to provide control of bleeding, to disinfect the surface and create favorable antibacterial conditions, and to provide protection against airborne organisms. A particularly advantageous application of the embodiment shown in and described in connection with FIG. 3, is in the case where the temporary dressing is used over lacerations or portions of lacerations not being attended to at the time, to create a dry, not bleeding surface for the time when surgical treatment is required. The temporary dressing can be progressively removed as for example, a permanent dressing is being applied with clips. The apertures 28 have a double function, to permit contact between the spongy substrate and the liquid secretions, and also to permit easier removal of the temporary dressing, from the surface to which it is applied. Suitably the openings 28 in the adhesive layer are not larger than about 4 mm diameter, thereby the pharmacological action of the portions of the adhesive layer adjacent to the apertures can also manifest itself in the areas disposed under the openings and not directly covered by the adhesive.

The pharmacologically active adhesive layer can be prepared by mixing 0.5-20 percent by weight. suitably about 8I0 percent by weight. solids basis, of tannic acid; 0.5-5 percent by weight. suitably 0.82.5 percent by weight. preferably 1.4- l .7 percent by weight. solids basis. of cinnamic alcohol; the balance of the solids is polyvinylpyrrolidone. The powdered ingredients are blended and then dissolved in sufficient amount of a suitable solvent, e.g. water. to obtain a viscous solution. Optionally additional ingredients can be substituted for PVP, such as 0.25-1 percent by weight. preferably about 0.5 percent by weight, solids basis. of cortisone or cortisone derivative to promote healing; 0.5-2 percent by weight, preferably about 0.7 percent by weight, solids basis of benzocaine or xylocaine to obtain increased analgesic action; and 0.04-0.09 percent by weight. solid basis of benzalkonium chloride if supplementation of the anti-bacterial action of the basic active adhesive is desired.

The viscous solution can be applied to one side ofa flexible. elastic substrate by any suitable coating technique. Thicknesses of 1/16" to A or more, suitably about slightly below /s", have been successfully used.

The elastic and flexible substrate is preferably of a porous nature to provide some padding against traumatic influences which may be encountered, and with open porosity to permit aeration of the wound. It is not necessary that the substrate be bulky, for example /a" thick foam rubber, such as is generally available for podiatric cushioning purposes, has been found most suitable as the substrate material for the present invention.

It is a further feature of some embodiments of the pharmacologically active adhesive compositions of the present invention that when formed into a film and dried, they can become brittle upon flexing of the substrate, the layer cracking along the lines of flexure and in adjacent areas. The number of cracks is enhanced upon application pressing of the dressing onto skin surfaces, and the fissures provide aeration of the wound through the adhesive layer militating thereby against the occurrence of gas gangrene and the like. Thin foam rubber webbing fulfills all requirements of elasticity and plasticity, and if desired, it can be easily cut to fit the size of any wound with only a very small margin outside the extremi ties of the wound, and if necessary it can be further adapted to the shape of the wound or the nature of the surface of the body on which it appears, by stretching, twisting and the like. The open pores on the coated sides of the substrate become impregnated by the adhesive layer of the invention, thereby serving as a repository of the active material for a release I thereof from time to time as the temperature of the wound increases, or as endogenous or exogenous liquids become available. These effects will bring additional amounts of the active adhesive into solution to become operative upon the wound, as is required. The dressing can be easily applied even over hairy surfaces without subsequent dislocation, especially because the moisture of the hair and the underlying skin will operate to further activate the adhesive action rather than to diminish it as was the case in many of the prior art adhesive dressings. Adhesive dressings in accordance with the present invention were placed over wounds in hairy regions and they were found to maintain their proper location for a period of several days, whereas controls of commercial adhesive-type first-aid bandage as well as simple gauze adhesive-type firstaid dressings failed to remain adherent to the hairy surface for even a full day. The adhesive dressing of the present invention remains well adherent during temporary exposure to moisture, such as a brief washing of the affected surface, however, upon somewhat prolonged soaking, such as in water, the dressing can be removed without any pain or discomfort. Alternatively, the adhesive can be removed in the dry state because of a selective tenacity of the adhesive character. This selective tenacity is manifested in that the adhesive successfully resists normal mechanical influences tending to remove the dressing, on the other hand it does not offer such resistance to more purposeful efforts associated with an intended removal of the dressing, such as the resistance manifested by the adhesive layers of freshly applied adhesive-type dressings of the prior art.

In the following examples some replicated experiments are set forth illustrative of some of the uses of the present invention.

EXAMPLE] A mixture is prepared of 2.92 g tannic acid powder U.S.P.. 0.71 g cinnamic alcohol powder, and 28.32g polyvinylpyrrolidone sold by the General Analine & Film Corporation under the trade designation K 2932. 22.2 ml water is added to the mixture, while stirring. The resulting viscous, yellowish 48 hours, is spread with a spatula over a 3/32" thick white, foam rubber webbing, with 29.6 ml of the solution covering about 258cm 2 of the substrate. The coating is allowed to dry at room temperature, resulting in a thin, pale yellowish, dryto-touch film covering one side of the substrate.

When a piece of the substrate coated in accordance with the present invention is placed alongside an uncoated, but otherwise similar foam rubber substrate, onto a blood agar plate previously contaminated with a culture of hemolytic staphylococcus pyogenes albus, and aureus and alpha streptococcus and then incubated for 48 hours no evidence is found of any colonies of growth of organisms under the area covered by the coated substrate, but several white colonies of growth are clearly in evidence on the surface of the blood agar portion covered by the uncoated foam rubber control. Upon reinoculation in a broth medium and reincubation for 72 hours again, similarly failed to give rise to any growth of organisms in the area covered by the coated substrate.

EXAMPLE 2 Bleeding time determinations are carried out on a large rabbit in accordance with the Duke method, as described in Brays Clinical Laboratory Methods, 6th Edition, C. V. Mosby Co., St. Louis, 1962. A No. Bard-Parker pointed knife is thrust into the skin of the rabbit, followed by free bleeding, then the time is recorded when the bleeding stops spontaneously. Compared to a generally 2-4 minute period required for stoppage of bleeding in the case of a wound covered by an uncoated foam rubber, coverage of the wound with a coated foam rubber in accordance with Example 1 results in a bleeding stoppage within up to 40 60 seconds sooner.

EXAMPLE 3 Deep lacerations are made with an unsterilized knife in the uncleaned abdominal skin of a large rabbit down to the peritoneum. Free bleeding is obtained from incisions of slightly less than an inch long and approximately gaping. The wound edges are pulled together with the thumb and forefinger and a foam rubber-backed dressing prepared in accordance with Example 1 is placed over the incision. The anesthesized animal is returned to its cage and is allowed to move freely as well as have access to the covered area. The animal is free to rub the areas of its body covered with the selfadherent dressing against the cage, and within an average of 5 days the rubber dressing is removed by the animal. No evidence of infection can be noted, and in 2 out of 3 incisions the wounds are closed and healed. ln Va of the cases a gaping wound is noted without the evidence of infection, the wound being dry and non-secreting in character.

EXAMPLE 4 2-3" long incisions are made in the abdomen of a large rabbit in an area cleared by a hair clipper, but without sterilization of the surface or the knife. The cut is all the way to the peritoneum with the occurrence of free bleeding. Gaping of /2 to l is observed. The edges of the wound are brought together as far as possible, and coated rubber dressing in accordance with Example 1, with Michel clips affixed thereto, is placed over the wound and the clips are squeezed together individually about the exposed edges thereof. Bleeding is immediately controlled and the coated surface of the rubber substrate becomes adherent to the underlying skin. Although within an average of 5 days the dressing is torn off by the rabbit and the wound is open, no evidence of infection is noted and the wound is dry and non-secreting.

EXAMPLE 5 A wedge-shape piece of the auricle of the ear of the rabbit is cut away. The location is selected to minimize, as far as possible, the freedom of the rabbit to paw and rub the location of the wound. A coated form of a segment prepared in accordance with Example 1 is attached by adhesion and with a clip on the posterior of the ear while bringing the edges of the wound together with one hand and using the thumb and forefinger for squeezing of the clip around the edges of the wound, with the clips enclosing the interior of the auricle, two more clips are applied. The bleeding is immediately controlled. After 5 days two of the clips become removed by the rabbit, but the wound is completely closed without any evidence of infection and healed.

EXAMPLE 6 A large, Z-shaped incision of approximately 4 /2 length is made with an unsterilized knife into the unsterilized side of the abdomen of the rabbit down to the peritoneum, with resulting free bleeding. A badly gaping, more than 1" wide wound is obtained. A large piece of coated foam rubber in accordance with Example 1 is placed over the irregular laceration, together with Michel clips in a fashion that the angular changes in direction of the Z-shape are deliberately not clipped together and left somewhat uncovered. Rapid stoppage of bleeding is observed. About 18 hours later the wound is still widely gaping with the only clips remaining at the very distal edges of the regular wound, but

these portions are all well approximated and not infected. No

infection can be seen in the remainder of the jagged wound and already 18 hours after the post-operative phase, the wound is dry and non-secreting. After 5 days the distal ends of the wound where the clips are retained, are well healed, while the remainder of the wound, even though gaping, is dry and without any evidence of infection.

lclaim:

l. A surgical implement comprising:

an elongated substrate of a webbing of foamed material,

said substrate having top and bottom surfaces;

a spline extending longitudinally of said substrate along the top surface thereof;

an adhesive coating covering the bottom surface of said substrate;

a plurality of skin clips carried on said spline at spaced intervals therealong, said skin clips extending in open condition downwardly from said spline through said substrate and outwardly of the adhesive coating on the bottom surface of said substrate; and

said adhesive coating being the residue of a solution of 0.5-

20 percent by weight solids basis of tannic acid, 0.5-5 percent by weight solids basis of cinnamic alcohol, and the balance of solids being polyvinylpyrrolidone.

2. The surgical implement of claim 1 wherein said spline is made of an easily deformable material, and said foamed material is provided with open pores.

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