Surgical Closure

Abstract

A sutureless closure device for use in surgery which is both an operative drape and a post-operative skin dressing. A flexible sheet having a pressure sensitive adhesive undersurface is adapted for placement on the skin over the area to be cut. The sheet is differentiated into two opposing dressing portions which remain on the skin as a post-operative dressing and which define a narrow median strip that acts as a surgical drape and can be removed at the end of the operation. One of the dressing portions of the sheet carries, on its upper surface, means for engagement with the opposite dressing portion whereby the engagement means can be connected to bridge the incision thereby forming a connected closure.

Description

BACKGROUND OF THE INVENTION

This invention relates to a novel surgical closure device which overcomes many of the obstacles and deficiencies of prior art sutures and adds the benefit of simultaneously being a surgical drape as well as a post-surgical dressing.

One very widely used prior art surgical technique is the suture or clips technique which comprises stitching or applying clips to the incision in order to close it, and requires subsequent removal of the stitches or clips. However, the suture or clip technique has several disadvantages. Often the needle or the clips will go through a blood vessel causing bleeding. Further, closing the incision by means of sutures or clips has been found to be very time consuming. Additionally, the removal of sutures or clips after several days causes added discomfort, inconvenience and such sutures or clips normally leave scars.

Another method used to close small wounds is the application of separate narrow adhesive strips such as STERI-STRIPS, manufactured by 3 M Company, to opposing skin edges. Such narrow adhesive strips can only be used on very small wounds because the closure tends to loosen and come apart with stress. My invention presents an improvement over the narrow strip method since it provides a substantially continuous closure for surgical wounds of any length. Another advantage of my invention is that it employs materials and methods capable of withstanding high tensions, such as Velcro. This closure will resist disruption in places such as the abdominal wall where coughing or sneezing or other expulsive efforts may disrupt the closure. Additionally, since the engagement adhesive of my invention or other means of engagement is mounted on a large adhesive sheet which is in turn in contact with the skin but which is applied to a prepared area of the skin at the optimum time (before the incision) thereby providing maximum bondage, the means of engagement remains free from wetness or oil or grease which cause the means of engagement in the strip method, for instance, to loosen and come apart.

It is therefore an object of the present invention to provide a surgical closure device which obviates the need for applying clips or sewing incisions closed, thus minimizing scar formation.

It is another object of the present invention to provide a surgical closure which enables the surgeon to close an incision in a rapid, effective manner without having to puncture the skin, thereby removing the possibility of bleeding caused by the closure.

A further object of the present invention is to provide a surgical drape and dressing closure which is placed on the patient prior to the incision, which aids the surgeon in providing a straight incision when desired, and which obviates the need for sutures.

An additional object of the invention is to provide a surgical closure which does not require the use of sutures and which allows the surgeon to selectively provide the proper amount of closure tension on the incision.

A still further object of the invention is to provide a sutureless surgical closure which includes a sterile surgical drape which improves aseptic techniques and eliminates the need for less efficient draping while simultaneously providing a surgical dressing.

My novel closure therefore combines the advantages of a sterile surgical draping sutureless closure and a surgical dressing in one device.

Other objects and advantages will become apparent from the following description, claims and the illustrations in the drawing.

BRIEF DESCRIPTION OF THE INVENTION

In accordance with the present invention, there is provided a closure device for surgical use which comprises a flexible sheet having a pressure sensitive adhesive undersurface. An intermediate portion is defined by two opposing side portions of the sheet, and is adapted for placement on the skin directly over the area to be cut. One of the side portions of the sheet carries, on its upper surface, means for engagement with the other side portion, whereby an incision through the intermediate portion can be made and thereafter closed with the engagement means bridging the incision to form a connected closure.

In an illustrative embodiment of the invention, the intermediate portion is formed of a surgical drape material fastened to opposing side portions which are formed of surgical dressing material. The flexible sheet is fastened to the undersurface of a top sheet of surgical drape material which is applied to the skin with the flexible sheet. After the incision is made and near the end of the operation, the top surgical drape is removed, the intermediate drape portion is torn from the opposing side portions, and the engagement means are then operated to bridge the incision to form a connected closure.

In another embodiment of the invention, the closure device includes a series of hook means carried on the upper surface of each of the side portions. The hook means are adapted to hold a thread which is connected to the hook means and tied after an incision is made and the operation is completed.

A more detailed explanation of the invention is provided in the following description and claims, and is illustrated in the accompanying drawing.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a view of one form of a closure device in accordance with the principles of the present invention;

FIG. 2 is a view of a second form of a closure device in accordance with the principles of the present invention;

FIG. 3 is a view of a connector for use with the closure device of FIG. 2;

FIG. 4 is a perspective view of another form of closure device in accordance with the principles of the present invention;

FIG. 5 is a cross-sectional view thereof, taken along the line 5 -- 5 of FIG. 4;

FIG. 6 is a fragmentary elevational view, taken from the left side of FIG. 4;

FIG. 7 is a top plan view of another form of a closure device in accordance with the principles of the present invention;

FIG. 8 is a cross-sectional view thereof, taken along the line 8 -- 8 of FIG. 7;

FIG. 9 is a top plan view of another form of closure device in accordance with the principles of the present invention;

FIG. 10 is a top plan view of a further form of a closure device in accordance with the principles of the present invention;

FIG. 11 is a perspective view of the closure device of FIG. 9, showing the closure device in position on the skin during an incision; and

FIG. 12 is a perspective view of the closure device of FIG. 9 after surgery is completed and the incision is closed by means of the device.

DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENT

The device of FIGS. 1 and 2 comprises a large basic flexible top sheet 10 preferably formed of surgical drape material such as the material having the trade mark STERI-DRAPE manufactured by 3M Company. Sheet 10 has a pressure sensitive adhesive undersurface so that it can adhere to the skin and for attachment to a flexible sheet 12 which sheet 12 is more clearly illustrated in FIG. 2.

Flexible sheet 12 and the portions of top sheet 10 which do not overlie sheet 12 have a pressure sensitive adhesive undersurface and are adapted for placement on the skin over the area to be cut. Sheet 12 is differentiated into a first dressing portion 14 and a second dressing portion 16, which dressing portions define a median strip 18 formed of a surgical drape material which can be removed at the end of the operation. The dressing portions comprise a porous dressing material as is well known in the art. Drape material 18 is connected to opposing dressing portions 14 and 16 by perforations so that material 18 can be easily torn and removed (as indicated in FIG. 2) at the end of the operation.

Dressing portions 14 and 16 carry on their upper surfaces, respectively, strips 20, 22 of Velcro material. As shown in FIG. 3, a connection strip 24, having Velcro tabs 25, 26 at its opposing ends, is used to bridge the area between Velcro strips 20 and 22 in order to form a connected closure after the incision is made and the operation is completed.

In the embodiment of FIGS. 4, 5 and 6, a flexible sheet 30, similar to flexible sheet 12, comprises two opposing side portions 32 and 34 formed of a dressing material and which define an intermediate tear strip 36 formed of a drape material. The engagement means comprise a first strip 38, formed of plastic or the like, and fastened to side portion 32. Strip 38 carries a number of beaded tie fasteners 40, each of which is preferably formed of plastic and includes flexible elongated portions 42 defined by beads 44. A second strip 46 is fastened to side portion 34 and includes a fastened base 48 having an upright portion 50 which defines equally spaced grooves 52. Grooves 52 align with respective beaded ties 40 and open upwardly as shown most clearly in FIG. 6. The width of grooves 52 is less than the diameter of beads 40 but is greater than the diameter of elongated members 42 so that members 42 can be inserted into grooves 50 with the beaded tie portion under tension and release will be prevented by abutment of bead 44 with the walls of portion 50 defining groove 52.

In the embodiment of FIGS. 7 and 8, flexible sheet 60 comprises opposing side portions 62 and 64 formed of dressing material, which opposing side portions define a tear strip 66 formed of drape material. The attachment means comprise a plastic base 68 to which is connected a number of ties 70, each of which has a stepped upper surface 72, as shown most clearly in FIG. 8. Side portion 62 has affixed thereto a base or pawl strip 73 which carries pawls 74 for engagement with surface 72 of tie 70. Strip 72, pawls 74 and integral hinge portions 76 are preferably formed of a plastic material in an integral, one-piece construction. Pawl 74 has a distal end 78 which engages the ratchet formed by top surface 72 of tie 70.

To operate the attachment means of FIGS. 7 - 8, ties 70 are inserted into recesses 80 defined by pawls 74 and the tie is moved in the leftward direction (with respect to FIGS. 7 and 8) to apply tension to the opposing side portions 62 and 64. Tie 70 is prevented from moving in the rightward direction (with respect to FIGS. 7 and 8) because of the engagement of distal end 78 with one of the notches as shown in FIG. 8. If for some reason release of tension on the tie is desired, pawl 74 can be forced in the clockwise direction by thumb pressure on portion 82 of the pawl, to release distal end 78 from engagement with the notch.

In the embodiment of FIG. 9, flexible sheet 90 comprises opposing side portions 92 and 94 formed of dressing material, which side portions define intermediate tear strip portion 96 formed of drape material. The engagement means of the FIG. 9 embodiment comprise Velcro material and adhesive strip material which connect to form an effective closure. Referring to FIG. 9, side portion 92 carries a number of Velcro strips 98 which are in spaced alignment for cooperation with Velcro tabs 100 carried by strips 102. Each of strips 102 has positioned thereunder a centrally located adhesive strip 104 for engagement with portion 105 intermediate a pair of Velcro material strips 98. Also located intermediate strips 102 are adhesive strips 106 which adapt to engage a portion of side portion 92 which is free of Velcro material. All of the adhesive strips are covered with a removable liner so that they will remain sterile in the manner well-known in the art. Intermediate portion 96 has a guide line 108 printed thereon which serves as a guide for the surgeon in providing a straight incision, if such a straight incision is desired. Guides for curved incisions may be provided.

In the use of the device of FIG. 9, referring to FIGS. 11 and 12, it is seen that flexible strip 90 is applied to the skin with intermediate portion 96 overlying the area to be cut. Prior to such application, the area of the skin about which an incision is to be made is cleaned thoroughly and is wiped completely dry. Excessively oily skin should be cleaned with rubbing alcohol and then dried thoroughly. In order to render the skin more adhesive, it may be treated with tincture of benzoin or other such substances which are well-known in the art, such as Ace Adherent manufactured by Beckton-Dickinson, or Vi-Drape adhesive manufactured by Parke-Davis. Flexible sheet 90 is then applied to the skin after removing the protective liner covering the adhesive undersurface and pressure is applied to affix it to the skin.

After the operation is completed, intermediate portion 96 is removed by tearing it as indicated in FIG. 9 and strips 102 carrying Velcro tabs 100 are connected to Velcro material strips 98. Thereafter the protective liners are removed from adhesive strips 106 which strips are connected to side portion 92. Thereafter Velcro strips 102 are removed from Velcro strips 98, the protective liners are removed from adhesive strips 104 and adhesive strips 104 are connected to portions 105, as shown in FIG. 11. Thereafter the Velcro strips 102 are reattached to apply the proper tension to the closure, with the resulting closure having the appearance as illustrated in FIG. 12.

After a predetermined number of days when the incision is healed to a predetermined degree, the entire flexible sheet 90 is removed from the skin. It is seen that there will be no scars from sutures or clamps.

Flexible sheet 90 could be entirely covered with a surgical drape material, as in the FIG. 1 embodiment. To this end, the entire flexible sheet 90 would be attached to the undersurface of a piece of surgical drape material having an adhesive undersurface and the entire unit would be placed on the skin with intermediate portion 96 overlying the area to be cut. After the incision is made and the operation is substantially completed, the top drape material (reference numeral 10 in the FIG. 1 embodiment) is removed just prior to removal of intermediate portion 96.

The attachment means could take the form of various types of hooks which would bridge the intermediate portion in order to close the incision. Another form of the invention is shown in FIG. 10 which comprises a flexible sheet 110 similar to sheet 90 and having a plurality of hooks 112 connected on opposing side portions 114 and 116, which side portions are formed of surgical dressing material and define removable intermediate portion 118 formed of surgical drape material. In using the device of FIG. 10, after sheet 110 is applied to the skin in the same manner as applying sheet 90 with respect to the FIG. 9 embodiment, the incision is made through the intermediate portion 118. After the surgical procedure is completed, the incision is closed by threading the device closed as indicated by the thread 120 in FIG. 10, similar to the conventional manner of lacing ice skates, and the thread 120 is tied closed at 122 with the desired amount of tension applied to provide the desired closure tension on the incision. In the FIG. 10 embodiment, hooks 112 are formed of a plastic material and are fastened to sheet 90 by means of tape 124, with the lower part of the hooks extending underneath the tape and piercing it. However, any suitable means for fastening hooks 112 to a flexible sheet 110 may be used.

It is seen that a surgical closure device has been provided which obviates the need for sewing the incision closed as is very often required using prior art techniques. It is apparent that by using the device of the present invention, a very rapid closure procedure is obtained and after the closure is performed and the device remains on the skin for several days, the entire device can be peeled off (in a similar manner as an ordinary bandage) without the need to remove sutures and without causing the scras which are a concomitant of prior art stitching techniques.

Although several illustrative embodiments of the invention have been shown and described, it is to be understood that various modifications and substitutions may be made by those skilled in the art without departing from the spirit and scope of the present invention. For example, the attachment means could comprise various types of tapes, hooks and other fasteners such as zippers. Of course, the attachment means must be suitable for sterilization, but many types of devices which can bridge the intermediate portion and permit a tension closure on the incision would be suitable and would be within the scope of the present invention.

Claims

What is claimed is:

1. A closure device for surgical use, which comprises: a flexible sheet having a pressure sensitive adhesive undersurface; an intermediate portion defined by two opposing side portions and being adapted for placement on the skin directly over the area to be cut; one of said side portions carrying, on its upper surface, means for engagement with the other side portion, whereby an incision through said intermediate portion can be made and thereafter closed with said engagement means bridging said incision to form a connected closure; and means for enabling simple removal of said intermediate portion from said side portions.

2. A device as described in claim 1, wherein said intermediate portion is formed of a plastic surgical drape material.

3. A device as described in claim 1, wherein said side portions are formed of a surgical dressing material.

4. A device as described in claim 2, wherein said side portions are formed of a surgical dressing material.

5. A device as described in claim 1, wherein said engagement means comprise a first engagement member connected to one of said side portions and a second engagement member connected to the other side portion, and an external fastening member for bridging the incision to connect said first and second engagement portions.

6. A device as described in claim 5, wherein said first and second engagement members comprise Velcro strips and said external fastening member comprises a member carrying Velcro material on its opposing ends.

7. A device as described in claim 5, wherein said first and second engagement members comprise hooks and said external fastening member comprises thread means for connecting the hooks on opposing side portions.

8. A device as described in claim 1, wherein said engagement means comprise Velcro material connected to said side portions.

9. A device as described in claim 1, wherein said engagement means comprise pressure sensitive tape means fastened to said one side portion, said tape means being of a length to span the intermediate portion and connect to said other side portion; and removable strip means covering the adhesive area of said tabs.

10. A device as described in claim 1, wherein said engagement means include laterally spaced means for permitting lateral adjustability of the closure engagement.

11. A device as described in claim 2, wherein said intermediate portion is light transmissive and has a printed guide line thereon.

12. A device as described in claim 1, in which said engagement means comprise a plurality of beaded tie fasteners connected to said one portion and means connected to said other side portion defining apertures for receiving said beaded tie fasteners.

13. A device as described in claim 12, wherein said apertures open to the outside of said means defining them.

14. A device as described in claim 1, in which said engagement means comprise a plurality of ties connected to said one side portion, each of said ties having a stepped upper surface to form a ratchet, and a plurality of pawls connected to said other side portion for engagement with said ties, said connected pawls and ties cooperating to prevent opening movement of said ties with respect to said pawls.

15. A device as described in claim 14, including thumb-operable means for releasing said pawls from the steps of said ties, said ties and pawls being formed of a plastic material.

16. A drape and closure device for surgical use, which comprises: a flexible sheet having a pressure sensitive adhesive undersurface; an intermediate portion defined by two opposing side portions and being adapted for placement on the skin directly over the area to be cut, said intermediate portion being formed of a plastic surgical drape material and said side portions being formed of a surgical dressing material; means for enabling simple removal of said intermediate portion from said side portions; one of said side portions carrying, on its upper surface, means for engagement with the other side portion, said engagement means comprising alternating Velcro-carrying tabs and adhesive strips, whereby an incision through said intermediate portion can be made, said intermediate portion can be removed and said incision can thereafter be closed with said engagement means bridging said incision to form a connected closure.

17. A drape and closure device as described in claim 16, in which said engagement means further comprise adhesive strips located on the underside of said Velcro-carrying tabs whereby said incision can be closed by connecting said Velcro tabs and said alternating adhesive strips, thereafter disconnecting said Velcro tabs and connecting said adhesive strips underlying said Velcro tabs, and thereafter reconnecting said Velcro tabs.

18. A device as described in claim 16, in which all of said adhesive strips and said flexible sheet have a removable protective liner.