US 3332417 A
Description (OCR text may contain errors)
y 25, 1967 w. F. BLANFORD ETAL 3,332,417
ADJUSTABLE WOUND PROTECTOR Filed April 22, 1965 INVENTORS PAUL CPEAGE Jk. W/LL/AM F BLANF'ORD ATTORNEYS g. m w E E TM 7- SflT uF M m P m. a
United States Patent 3,332,417 ADIIETABLE WOUND PROTECTOR William F. Blanford and Paul Creager, .lr., Dayton, Ohio, assignors, by mesne assignments, to Parke, Davis & Company, Detroit, Micln, a corporation of Michigan Filed Apr. 22, 1965, Ser. No. 450,010 4 Claims. (U. 128132) The present invention relates to adjustable devices for protecting the edge of a wound from bacterial contamination during surgery and particularly to practical devices which are thereby able to accommodate a wound of unpredictable size as is encountered in actual surgery. It will be understood that the wound which is to be protected is provided by a surgical incision.
In accordance with standard surgical practice, it is common for the surgeon to position a laparotorny pad over each side of the incisional wound. These pads become moist and, by capillary action attract bacteria to the wound edge. They also slip out of position and are bulky. Rubber dams or plastic sheeting can be used instead of a laparotomy pad, but unless these are sewn to the peritoneum and adhered to the skin, they tend to slip out of position. The invention is directed to the provision of a skin-peritoneal drape device which will provide a continuous covering for the entire wound surface from the outer skin edge to the inner peritoneal edge and which will be self-retaining while still being capable of withstanding retractor forces and serving to safeguard the wound surfaces from bacteria and other detrimental agents. It will be understood that the surface of the human skin and also the surface of the peritoneum or body organs, such as the intestines, are reasonably well immune to infection, when intact, but when any of these surfaces are interrupted by such procedures as a surgical incision, the intervening tissues which are exposed are peculiarly susceptible to infection and its is therefore of considerable importance to properly safeguard these traumatized tissues from infection as the operation proceeds. Thus, the main objective of the invention is to isolate the incisional edge from contamination from sources within the patients abdominal cavity as well as from contamination on the exposed exterior surface of the patient.
In accordance with the invention, a thin flexible plastic sheeting is positioned around the entire circumference of the wound opening with the inner and outer edge of the sheeting being held in place by resilient rings strong enough to resist buckling, the inner ring underlying the peritoneum and the outer ring overlying the skin. The invention is based on the need for adjustable devices which can be cut to whatever length is desired and in which a tongue element is employed to overlap the opposite end of the unit which is cut in order to form a tubular device of the precise size which is needed and which can accommodate significant expansion when retractors are applied or if the length is misjudged when the structure is cut to length.
The invention will be more fully described in connection with the accompanying drawing in which:
FIG. 1 is a plan view showing an adjustable structure constituted in accordance with the preferred practice of the invention;
FIG. 2 is a cross-section taken on the line 22 of FIG. 1;
FIG. 3 is a cross-section taken on the line 33 of FIG. 1;
FIG. 4 is a perspective view showing the device of FIG.
3,332,417 Patented July 25, 1967 1 after it has been cut to size and assembled for use in surgery; and
FIG. 5 is a perspective view, on an enlarged scale, and showing a portion of a device constructed in accordance with the invention in use in surgery and identifying the tissues which are enclosed thereby.
Referring first to the plan view of FIG. 1, the wound protector shown is supplied in sterile form and as a strip of stock material which is cut to size by the surgeon after the incision has been completed.
The body of the strip is formed by a thin, elongated sheet of plastic 21 which is bordered on its opposite lateral edges by rod-like elements 22 and 23 which, in the preferred structure of FIG. 1, are constituted by resilient plastic tubes. The width of the sheet 21, while subject to considerable variation within the ambit of the invention, is normally preselected to be within the range of from 3 to 8 inches, preferably about 3 /2-6 /2 inches. These plastic tubes are secured to the lateral margins of the elongated sheet 21 in any convenient manner, but preferably by wrapping the lateral margins about the tubes 22 and 23 and then heat-sealing to provide the desired securement shown in cross-section in FIGS. 2 and 3. The forward ends of the rod-like elements or plastic tubes 22 and 23 extend forwardly of the plastic sheet 21 as indicated at 24 where they are fitted with attaching devices, in this instance rods 25 and 26 inserted into the open end of the tubes 22 and 23. As will be evident, the free ends of the rods 25 and 26 are intended to be inserted into the open opposite end of the tubes 22 and 23, after the structure has been cut to length in order to complete the upper and lower rings of the wound protector and thereby provide the annular structure which is intended. The rods 25 and 26 fit into the tubes Hand 23 with a friction tit which holds them against withdrawal by reason of any pulling force exerted in use. The tubes 22 and 23 are desirably movable with respect to the sheet 21 to facilitate construction of the tubular protector as shown in FIG. 4.
The sheet of plastic 21 is provided 'with or formed to include a forwardly protruding strip 27 which constitutes a tongue projecting forwardly between the protruding ends 24 of the rod-like elements 22 and 23. The purpose of this tongue 27 will be apparent from a review of FIG. 4 in which the end of the strip 21 including the tubes 22 and 23 have been severed to provide a severed edge 32 at the end remote from the tongue to provide a strip of desired length which is encircled upon itself with the rods 25 and 26 being inserted into the open ends of the tubes 22 and 23 in order to provide the structure shown in FIG. 4 Where it will be observed that the tongue 27 overlaps the opposite end of the strip 21 to complete the tubular structure. The length of the tongue can vary from 2 to 8 inches, a length of about 3-5 inches being presently preferred.
The tongue 27, in use, is preferably positioned in direct contact with the traumatized tissue so that the end of the strip remote from the tongue will trap the tongue against the body of the patient and keep it out of the way. On the other hand, this is not an essential of the invention and the tongue, if desired, may be permitted to remain on the inside of the wound protector where it is not particularly detrimental, especially since the retractor devices tend to keep the tongue pressed outwardly away from the wound opening.
Referring briefly to the structure shown in FIGS. 2 and 3, it will be seen that the forward ends of the lateral margins or running edges of the sheet 21, identified by 3 numerals 28 and 29, are visible in FIG. 2, with the tongue 27 extending forwardly thereof. The margins of the sheet 21 which have been wrapped around the tubes 23 and 24 are identified by the numeral 30 and the heatseal or other securements are identified by the numeral 31 FIG. is of interest in showing the wound protectors of the invention in actual use, this figure including identifying numerals showing the utilization of the structure of FIG. 4 therein. It will be obvious that the Wound edges collapse against the plastic sheeting 21 and the tubes 22 and 23 constituting the inner and outer rings serve to retain the sheet 21 in place as the operation proceeds. If one desires to hold the wound in an open position then one would use conventional retractors (not shown) after the wound protectors of the invention have been positioned. It is desired to stress that the showing of FIG. 5 is diagrammatic since the plastic sheeting 21 tends to wrinkle as it conforms with the body tissue. However, the wrinkling which takes place can be tolerated, it being noted that the capacity of the structure of the invention to conform to the size and shape of the incision reduces the amount of wrinkling which is encountered.
In application, the device can be assembled and then inserted into the wound by merely guiding one of the resilient rings into place beneath the peritoneum. The action is quite simple with the fingers being used to insert the ring first at one point and then progressively around the wound until the inner ring is completely inserted. On the other hand, one side of the strip can be inserted and the inner ring formed within the wound.
The procedure to be adopted is, to considerable extent, one of surgeon preference. It is easier to complete the rings (especially the inner ring) before the device is inserted in the wound, but when this is done, it is harder to know exactly what length of strip should be severed. On the other hand, when the unassembled wound protector strip is inserted, it is somewhat more difiicult to cut off the unwanted portion thereof and to complete the resilient rings but, at the same time, the problem of precise sizing is eased. It follows from the foregoing that some surgeons will estimate the length of strip to be employed, cut the strip to the estimated length, and assemble the inner and outer rings prior to insertion of the Wound protector within the wound. Other surgeons will prefer, for greater ease of sizing, to complete the serving and assembly operations while the protector device is in place in the wound.
It is desired to point out that the plastic sheeting which is employed in the invention need merely be inert, nontoxic, impermeable to liquids and bacteria, and reasonably thin and flexible so that it will conform readily to the body elements which collapse against it while retaining sufficient strength not to be disrupted by the forces imposed upon it. Plastic sheet material of the order of 2 mils in thickness and of sufiicient strength to avoid ripping in use is particularly appropriate. It is also desired that the plastic sheeting be transparent so that the condition of the body tissue can be observed through the film as the operation progresses and, of course, the sheeting should withstand sterilization.
While single sheets of materials are primarily contemplated, laminates are also possible so long as the material used is thin and flexible as has been indicated.
The specific nature of plastic sheet material which is useful does not constitute a critical aspect of the development and numerous synthetic resin sheet materials are useful such as polyvinyl sheeting including polyvinyl chloride, copolymers of 80-90 weight percent of vinyl chloride with -20 weight percent of vinyl acetate or vinylidene chloride, polyvinylidene chloride, polyethylene, polypropylene and polyethylene terephthalate. While these materials illustrate preferred resins, it will be understood that many other resins would be suited to the production of sheet material which is of suflicient flexibility to conform and of sufficient strength not to be ripped in use and which possess the other attributes noted hereinbefore.
It is desired to point out that the structure of the invention provides a far more practical surgical tool than those previously available, because the tongue 27 provides an important capacity to accommodate retractor expansion as well as avoiding the need for a large stock of presterilized wound protectors of every imaginable size.
In this connection, it should be noted that judging the appropriate size for a preformed circular structure with regard to a particular wound is quite difficult and the invention provides a capacity to accommodate the size of the structure once it is positioned Within the wound. A150, and in connection with presized structures, if the protector selected is too small, then the wound extremities are not adequately covered. It the protector employed is too large, then the plastic sheet material buckles to interfere with the surgery in progress or to expose the traumatized tissue behind the buckle.
Of further and considerable importance is the fact that surgery requires the longitudinal wound incision to be widened by the use of retractors in order to enable the surgical operation to proceed. When retractors are used, the opposite portions of the wound protector adjacent the opposite ends of the incision are moved toward one another as the stretching forces imposed by the retractors on the perimeter of the wound cause the circumference of the wound to be increased. As the opposite ends of the wound protector move inwardly, there is a danger that the traumatized tissue at the end of the incision may be exposed to infectious environment.
The adjustable structure of the invention avoids the need to precisely predetermine the length of incision which is to be used, the extent of retraction which will be needed, or to estimate the thickness of the peritoneal layer and associated tissues which will be encountered and which vary within a range of from 1 to 4 inches or more. In the invention, and as retractors expand the wound opening to stretch the same and increase the circumference of the wound, the tongue is able to maintain a continuous and unbroken protection around the circumference of the wound.
As will be understood, the products of the invention are distributed in sterile form within a package of any desired construction and which will enable the structure of the invention to be withdrawn while maintaining its sterility. Numerous package structures capable of providing such a result are known and will not be discussed. Sterilization can be effected in any desired manner as by the use of steam or other sterilizing gas such as ethylene oxide.
The invention is defined in the claims which follow:
1. A device for protecting the edge of a wound during surgery, comprising a thin elongated sheet of flexible plastic secured at each of its lateral edges about resilient rod-like elements, said rod-like elements each protruding forwardly at one end of said sheet of plastic and carrying an attaching device secured thereto, said sheet of plastic having a forwardly protruding strip of plastic sheeting constituting a tongue which projects between the forwardly protruding ends of said rod-like elements as an extension of said sheet of plastic.
2. A device as recited in claim 1 in which said thin flexible plastic sheet is a film of plastic having a width of from 38 inches and a thickness of about 2 mils.
3. A device as recited in claim 1 in which said rod-like elements are constituted by plastic tubes and said attaching devices are rods partially inserted in said tubes and fn'ctionally held therein.
4. A device for protecting the edge of a wound during surgery, comprising a thin elongated sheet of flexible plastic secured at each of its lateral edges about resilient rod-like elements, and formed into a tube, opposite ends of each of said rod-like elements being secured to an attaching device to provide upper and lower resilient rings, one end of said sheet of plastic carrying a forwardly pro- 5 truding strip of plastic sheeting constituting a tongue 2,170,060 which overlaps the opposite end of said sheet of plastic. 2,335,293 2,558,414 References Clted 2,778,362 UNITED STATES PATENTS 5 3 07 45 1,405,689 2/1922 Heatwole 128-136 2,059,136 10/1936 Moller 128-133 6 Meyer 206-4534 Meyer 206-4534 Blackman 2-49 Pallock et a1 l28283 Mason l28283 ADELE M. EAGER, Primary Examiner.