IE41711B1 - Surgical drape - Google Patents

Abstract

1473768 Surgical drape sheets JOHNSON & JOHNSON 22 Sept 1975 [12 Dec 1974] 38788/75 Heading A5R A surgical drape comprising a sheet of flexible material having a main portion at one end thereof, and a pair of spaced wings 60, 70 at the other end thereof and defining therebetween a gap, is provided with flaps 80, 80' each secured by adhesive or stitching to one respective wing along the side edges of said gap, whereby in use the leg of the patient is extended through the gap and the flaps are unfolded to overlie or underlie the opposed wing and the leg may then overlie the superposed layers. The drape is packaged with the flaps folded over their respective wings and the drape folded so that the drape may be placed over a patient, the folded wing portions B, C, unfolded around a leg and then the folded main portion A unfolded over the body of the patient. Alternative embodiments, Figs. 1-5 (not shown), may be provided with only one flap, and the flap may be secured to its wing along a side edge of the drape, intermediate a side edge and the gap, or adjacent the outer end of the wing, transverse to the gap. A reinforcement may be provided around the gap, Fig. 5 (not shown), comprising a sheet of absorbent material preferably with a sheet of plastics material interposed next to the drape material. The drape material may be woven, non-woven or plastics film.

Description

The present invention relates to new and improved surgical drapes of the type which comprise a flexible sheet having a main portion and wing portions whose inner edges define a slit or gap (hereinafter gap for convenience) which extends inwardly from an outer edge of the drape. Such drapes are especially useful in orthopedic surgery, neuro-surgery, and similar surgical procedures.

In preparing for orthopedic and related surgery it is common practice to cover the patient and operating table with a sterile drape, or drapes, in such a way that only the limb (or portions of the limb) on which surgery is to be performed is presented to the surgeon and his assistants.

One drape that has been provided for orthopedic and similar surgery comprises a sterile sheet having a main portion and an elongated gap extending outwardly from a central region thereof to an outer edge to provide two spaced wing portions. Such drapes are frequently referred to as split sheet drapes.

One draping procedure for using these drapes involves raising the patient's limb and putting it through the gap in the sheet in such a way that, when the draping is completed, the limb on which the operation is to be performed extends through the gap and lies on the upper surface of the main portion of the drape. The wing portions of the drape are then disposed to overlie parts of the patient's body at a region adjacent the operative site.

It is necessary, of course, to ensure that a sterile surgical field be provided at the outset of the surgical procedure and that the integrity of the sterile field be maintained until the surgical procedure is completed. In order to establish the sterile field and to prevent the contamination thereof in the event the wing portions of the split sheet should slip or be accidentally moved during surgery, it has been found necessary, prior to placement of the split sheet, to cover the patient with an auxiliary surgical drape.

The auxiliary drape is placed over that portion of the patient's body which will underlie the gap in the split when the latter has been positioned.

The need for using such auxiliary drapes represents an inconvenience to the operating room staff in that at least two drapes must be handled and put into position. Furthermore, the use of two or more drapes increases the time that must be devoted to the draping procedure and correspondingly delays the start of the surgical procedure The improved surgical drape of the present invention for use in orthopedic and similar surgery, eliminates the need for the aforementioned auxiliary drape. The drape of the present invention thus simplifies the draping procedure, saves valuable time, and reduces costs.

According to the invention we provide a surgical drape comprising when laid out flat a unitary sheet of flexible, drapable material having a main portion at one end thereof and a pair of spaced wings at the other end thereof, said wings extending outwardly from a central region of the sheet and defining in the sheet a gap extending inwardly from an outer edge of the sheet; and on at least one of the wings, a flap which extends transversely from the wing so as to cover at least a lengthwise portion of the gap and to lie over and in contact with at least part of the other wing. The sheet may be composed of a plastics film or a woven or nonwoven fabric. The flap is also flexible and drapable and is preferably attached to the wing at the inner edge thereof adjacent the gap, and may likewise be of woven, non-woven, plastics film or similar material. The flap extends far enough to cover the width of the gap and at least part of the upper or lower surface of the other wing portion. Preferably, the flap, or at least the portion thereof intended to cover the gap, is of sufficient length to extend along the major portion of the length of the gap.

The gap in the drape of the present invention may vary in width from substantially zero inches (as would be the case if a slit were formed in the sheet by cutting it with a knife or scissors) up to the diameter of the - 4 41711 limb on whioh surgery is to be performed. The latter dimension depends on the size of the limb on which surgery is to be performed, but normally would be expected to be, for example, from 3 inches to 5 Inches in the case of an operation on the thigh portion of the leg. A gap measuring from 2 inches to 4 inches in width would be suitable for arm surgery. The gap extends from an outer edge of the drape and terminates inwardly of the drape.

In another embodiment of the present invention, each of the wing portions of the drape has a flap at its inner edge. Such a drape can be used, as will be seen hereinafter, to provide a double layer of draping material which can either overlie parts of the body adjacent the site of surgery or which can be arranged under a limb which is to be subjected to surgery.

As used herein, the term nonwoven fabric includes a layer of overlapping, intersecting fibers which are bonded by suitable adhesive means, as well as paper made from short length fibers using conventional paper making techniques.

The invention will be better understood upon reading the following detailed description and upon reference to the appended drawings, in which: Fig.l is a top plan view of a first embodiment of a surgical drape in accordance with the present invention, with the drape being folded out flat and with the flap of the drape being folded back upon one wing portion to reveal the gap in the drape: Fig.2 is a cross-sectional view at an enlarged scale taken along lines 2-2 of Fig.l and showing the manner in which the flap is attached to the wing; Fig.3 is a top plan view of the drape of Fig.l, but showing the flap in a position overlying a substantial portion of the length of the gap and covering part of the other wing portion of the drape; Figs.4a, 4b, and 4c are partial top plan Views showing alternative arrangements for attaching the flap to the wing portion; Fig.5 is a top plan view of a drape similar to that shown in Fig.l with the addition of a reinforcing panel on its upper surface; Fig.6 is a top plan view of a second embodiment of a surgical drape wherein each of the wing portions has a flap; Fig.7 is a cross-sectional view at an enlarged scale taken along lines 7-7 of Figure 6 and showing the manner in which the flaps are attached to the wings; Fig.8 is a perspective view of the drape of Fig. showing each flap folded and overlying the wing portion to which it is attached and showing in broken lines the fold lines for the longitudinal folding of the drape; Figure 9 is a plan view similar to Figure 6, showing the drape in an intermediate stage of folding wherein the flaps have been folded transversely and the main portion of the drape has been folded longitudinally; Fig.10 is a diagrammatical cross-sectional view taken along lines 10-10 of Fig.9; Fig.11 is a top plan view, at an enlarged scale, of the drape of Figure 6 after the longitudinal folding thereof has been completed; Fig.12 is a diagrammatical cross-sectional view taken along lines 12-12 of Figure 11; and - 6 41711 Figs. 13-18 are perspective views showing the sequence of steps in draping a patient for leg surgery with a drape of the type shown in Figures 6-12.

For convenience we refer to the surface of the drape which normally faces uppermost when the drape is in use, as the upper surface, and that which faces down as the lower surface; that edge of the drape which is at the top in the accompanying drawings is referred to as the top edge, the opposite edge being the bottom edge and these edges being joined by the side edges of the drape; the wing portions are thus towards the top of the drape.

Referring more particularly to Figures 1-3, which show one embodiment of the present invention, surgical drape 10 comprises a flexible sheet 11 made from a single piece of a suitable drapable material. Preferably, the material ls a drapable nonwoven fabric, such as a scrim reinforced tissue or a wet-formed nonwoven fabric 2Q containing long fibers. Flexible sheet 11 comprises a main portion 12, at one end thereof, and a pair of spaced wings 20 and 30 at the other end thereof. The perimeter . of the drape includes opposed side edges 16 and 17 and bottom edge 15.

Wing portions 20 and 30 are integral with and extend outwardly from, main portion 12. Wing portion 20 has an inner side edge 24 and top edge 26. Correspondingly, wing portion 30 has an inner side edge 34 and a top edge 36. The top edges of the wing portions define the top edge of the drape.

Drape 10 has a gap 45 at least part of which is defined by the adjacent inner edges of the wing portions and whioh extends from the top edge of the drape inwardly to a generally central portion thereof. The gap has an open end, i.e., an end which communicates with the top edge of the drape, and a closed end, i.e. an end whioh is located generally centrally of the drape. The olosed end of the gap may be of any desired configuration.

When, for example, the inner edges of the wing portions are linear, the gap will assume the configuration of an elongated rectangle (the width of which will be determined by the distance between the adjacent inner edges of the wing portions) and the closed end of the gap will be squared off. Where the adjacent inner edges of the wing portions have curved portions inwardly of the drape, the closed end of the gap will assume a curved configuration. Preferably the closed end of the gap has a curved configuration such as that shown in Fig.l since, as will be seen hereinafter, this provides a drape whioh more readily conforms to the contours of the body when the drape is in use.

Inner side edge 34 of wing portion 30 carries a flap 40 of drapable material, whioh, as illustrated in Fig.3, may be folded across gap 45 and lie in overlapping relationship with wing portion 20. Although Fig.3 shows flap 40 overlying and covering part of the upper surface of wing 20, it is also contemplated that these two elements may be arranged so that wing 20 overlies sheet 40. This will be described in greater detail in connection with the detailed description hereinafter of the unfolding - 8 41711 and use of the drape. The term overlapping relationship is used herein to describe both of the above mentioned arrangements of sheet 40 and wing portion 20.

Flap 40 has a bottom edge 41, a top edge 42, and side edges 43 and 44. The bottom and top edges of flap 40 are substantially equal in length and are sufficiently long so that the flap can be folded across gap 45 and lie in overlapping relationship with at least part of wing 20. Referring especially to Fig.3, it is seen that the length of the flap along side edges 43,44 is somewhat less than the length of gap 45. Flap 40 runs inwardly along inner edge 34 from a point inward of the top edge of wing 30 to a point near the closed end of gap 45.

The particular part of wing 30 to which flap 40 is attached is not critical, provided, of course, that the flap can be folded across the gap and lie in the aforementioned overlapping relationship with wing 20. Preferably, however, the flap is attached to the wing at or near its inner side edge 34, since a minimum amount of material is thue required and unnecessary bulkiness in the folded drape is eliminated. As illustrated in Figs.2 and 3 flap 40 is fastened, along a line adjacent its side edge 44, to the upper surface of wing 30 a slight distance from its inner side edge 34. This is conveniently accomplished by stitching (indicated by dashed line 39 in Figs.l and 2), but other fastening means, such as an adhesive, may be employed if so desired.

The manner of attaching the flap to the wing is illustrated in Fig.2. A marginal portion of flap 40 adjacent its side edge 44 is rolled beneath the remainder of the flap so that part of upper surface 46 of the flap is disposed in a face-to-face relationship with upper surface 32 of a wing 30. As mentioned the flap is conveniently secured to the wing by stitching 39. When the flap is attached to the wing in the manner just described, there will be no folds or bulky portions on the upper surface of the drape when the drape is in use.

It will be apparent that the flap can be attached to the wing in other ways. For example, a portion of the flap adjacent its top edge 42 could be secured by stitching 39, or other securing means, to wing 30 near its top edge 36 (see Fig.4a). Alternatively, the flap could be attached to the wing at, or near, side edge 16 of the drape (Fig.4b) or at some point intermediate inner edge 34 and the side edge of the wing (Fig.4c).

The drape of the present invention may be made from the well known linen materials, such as woven cotton cloth, commonly used in hospitals. Preferably, however, flexible sheet 11 (comprising main portion 12 and wing portions 20 and 30) and flap 40 comprise a nonwoven fabric of adequate tensile and tear strength. The nonwoven fabric should be soft and have good draping and folding characteristics. Additionally, of course, the nonwoven fabric must be capable of being subjected to a sterilization treatment without being adversely effected thereby. The use of nonwoven fabrics eliminates the laundering, resterilization, and handling costs associated with linen drapes, since drapes made from nonwoven fabrics are discarded after use. The use of nonwovens in surgical drapes is well known and the selection of a nonwoven fabric having the above mentioned qualities is within the skill of those working in this art. More preferably, the nonwoven fabric used in constructing the drape is, or is treated to be, repellent to liquids such as water, body fluids and other liquids commonly encountered during surgery. In this way any liquids which come into contact with the major surfaces of the drape are prevented from striking through the drape and establishing a path for the transmission of bacteria. Methods for rendering nonwoven fabrics repellent to liquids are well known in the art and are not part of the present invention.

Referring now to Figure 5, there is shown a modification of the surgical drape of Figs.1-3. The drape has a reinforcing panel 48 on its upper surface in the regions adjacent gap 45. The reinforcing panel may comprise one or more layers of the aforementioned flexible materials. Preferably, however, the reinforcing panel has an absorbent upper surface 48a. An impervious plastics film (shown as dotted line 49 in Fig.5) is interposed between the reinforcing panel and the main sheet of the drape. The upper surface of the reinforcing panel provides absorbency at the operation site to absorb body and other fluids encountered during surgery. The impervious plastics film prevents fluids from striking through the drape to the patient.

The reinforcing panel can be affixed to the drape by, for example, a suitable adhesive.

Referring now to Fig.6, there is shown another embodiment of the present invention. Drape 50 is generally the same as drape 10 of Figs.1-3, except that each of its wing portions carries a flap-like sheet. Drape 50 comprises a sheet 51 of drapable material having a main portion 52 and opposed wing portions 60 and 70 extending therefrom.

The drape has a gap 85 which extends inwardly from the top edge of the drape and which is defined by inner side -1141711 edges 64 and 74 of wings 60 and 70, respectively.

The drape also has a bottom edge 55, a bottom portion 55·1· adjacent said bottom edge, and side edges 56 and 57. The drape has an upper surface (the surface exposed to the viewer in Fig.6) and a lower surface (the surface not seen by the viewer in Fig.6).

Flap 80 is attached to wing 60 in the manner illustrated in Fig.7. A marginal portion of flap 80 is folded over inner edge 64 of wing 60 and continued a short distance along lower surface 63 of the wing. The flap may be secured to the lower surface of the wing by, for example, a suitable adhesive 65. Similarly, flap 801 is folded over inner edge 74 and is secured to lower surface 73 of wing 70. If desired, the flaps may be secured to the wings in the same manner as flap 40 is attached to wing 30, that is, in the manner illustrated in Fig.2.

Drapes of the present invention may be folded into a compact unit Which facilitates handling during packaging and storage and which permits the drape to be easily and quickly applied to the patient prior to surgery.

As used herein a forward fold is a fold in which the upper surface of the drape is turned toward itself around a fold line. A reverse fold is a fold in which the upper surface of the drape is turned toward the lower surface of the drape around a fold line. In the drawings, the letter R indicates a reverse fold and the letter F indicates a forward fold. The numbers preceding the letters F and R refer to the order in which the folding is done.

The preferred method for folding drape 50 from end to end is illustrated in Figs.8-12. As seen in Fig.8, - 12 41711 flaps 80 and 801 are fan-folded to form two stacks of folds overlying wings 60 and 70, respectively. Main portion 52 of the drape is folded next. Bottom portion 551 adjacent bottom edge 55 of sheet 51 is forward folded, toward the center of the drape, around fold line IF. The main portion is then reverse folded around fold line 2R, forward folded around fold line 3F, reverse folded around the line 4R, and forward folded around fold line 5F.

As best seen in Fig. 8, top end portion 53 of main portion 52 is defined by fold line 5F, the sides of the drape, and transverse line 54 (shown in dot and dash) along which the wings extend from main portion 52.

Thus, as illustrated in Figs. 9 and 10, the above described folding sequence provides a stack A of folds which overlies a substantial part of the upper surface of end portion 53.

The wings (with their flaps already fan-folded as shown in Fig. 8) are folded next. A part of wing 70 adjacent top edge 76 thereof is forward folded around fold line 6F. Thereafter wing 70 is reverse folded around fold line 7R and forward folded around fold line 8F. It will be observed that the closed end of gap 85 is disposed between fold line 8F and transverse line 54. As seen in Fig. 12, this folding of wing 70 (including its associated flap 801) provides a stack B of folds which overlies stack A of folds. Wing 60, with its flap 80, is then folded in the manner just described for wing 70 to provide a stack C of folds which overlies stack A of folds. Fig. 11 shows drape 50 after it has been folded in accordance with the above described folding procedure. It will be noticed that the closed end of the gap is now exposed to view at the upper portion of the folded unit. This positioning of the closed end of the gap greatly facilitates place- 13 41711 ment of the drape prior to surgery, as the limb on whioh surgery is to be performed will extend through this portion of the gap when the patient is completely draped.

Each end of the drape in the elongated, longitudinally folded form shown in Fig.11 may then be folded, toward the center, to give a final compactly folded drape. Although an ordinary fan fold is suitable for this purpose, it is preferred that a modified fan fold be used. The term fan-folded refers to a folding sequence in which the material being folded has alternate forward and reverse folds. The term modified fan fold refers to a folding sequence which is similar to a fan fold but in which the first two folds thereof are of the same type. An example of a modified fan fold sequence is forward, forward, reverse, forward, reverse, forward.

Thus, the transverse folding of the partially folded drape shown in Fig.11 is begun from side edge 56 with a forward fold. The second fold is likewise a forward fold while the third fold is a reverse fold.

The forward and reverse fold sequence may subsequently be repeated until the desired degree of compactness is obtained. The transverse folding of the drape from side edge 57 toward the center is accomplished in the same manner.

Referring now to Figs.13-18, there is illustrated in stepwise fashion a method of applying the drape of Fig.8, folded as described, to a patient about to undergo surgery on the right knee. Fig.13 shows drape 50, unfolded from side to side, placed across the upper thigh portions of the patient's body with the gap thereof more or less lined up with-the patient's right leg. An assistant stationed at the patient's left side unfolds stack C of folds toward the patient's feet to cover the patient's left leg. As shown in Fig.14, this exposes flap 80 in its folded position overlying wing 60. An assistant on the right side of the patient lifts the patient's right leg upwardly (see Fig.15) and unfolds flap 80 across the operating table. While still holding the patient's right leg in the upraised position shown in Fig.15, the assistant on the right side of the patient then unfolds stack B of folds toward the patient's right foot. As shown in Fig.16, wing 70 now overlies flap 80 and flap 801 is exposed in its folded configuration overlying wing 70. While the patient's right leg is still upwardly raised, the assistant on the left of the patient unfolds flap 80^ across the operating table. As shown in Fig.17, flap-like sheet 80*· now overlies part of wing 60 and there is advantageously provided a double thickness of draping material between the operating table and the leg on which surgery is to be performed. Referring to Fig.18, the patient's right leg is lowered so that it lies on the upper surface of wing 70 (and possibly also on part of flap 80^). The draping procedure is completed by unfolding stack A of folds toward the patient's head, so that the main portion of the drape covers the upper torso of the patient.

It will be recognized that, once the draping is completed, the limb on which surgery is to be performed will extend through the closed end of the gap and will be contacted with the drape material. This arrangement advantageously isolates the patient from various fluids, such as blood and the like, which are normally encountered during surgery. Thus the remaining portions of the patient's body, that is, those on which no surgery is to be performed, are protected from bacteria originating in the operative area. Similarly, the operative site is protected from contamination by bacteria originating from areas remote from the operative site.

It will be understood by those skilled in the art that drape 10 of Figs. 1-3 may be folded in the manner described herein for drape 50. Drape 10, of course, has two wings, but only one of the two wings has a flap. Drape 10, when folded longitudinally, would look substantially like drape 50 in the folded form illustrated in Fig.11, each wing being folded into a stack of folds. If the wing having the flap be first unfolded longitudinally, and the flap attached thereto be next extended transversely (while the limb to be operated on is uplifted), then the flap would be under the other wing after the latter is subsequently unfolded longitudinally. Where the wing without the flap is first unfolded longitudinally and the wing having the flap is next unfolded longitudinally, the flap, after it has been unfolded transversely, would lie over the wing without the flap.

Claims (15)

1. CLAIMS:1. A surgical drape comprising when laid out flat: a unitary sheet of flexible, drapable material having a main portion at one end thereof and a pair of spaced 5 wings at the other end thereof, said wings extending outwardly from a oentral region of the sheet and defining in the sheet a gap extending inwardly from an outer edge of the sheet; and on at least one of the wings, a flap which extends transversely from the wing so as to cover at 10 least a lengthwise portion of the gap and to lie over and in contact with at least part of the other wing.

2. A drape according to Claim 1, wherein the sheet comprises a woven fabric.

3. A drape according to Claim 1, wherein the sheet 15 comprises a plastics film.

4. A drape according to Claim 1, wherein the sheet comprises a nonwoven fabric.

5. A drape according to Claim 4, wherein the nonwoven fabric is fluid repellent. 20

6. A drape according to any preceding Claim, wherein a reinforcing panel is secured to the sheet adjacent the gap.

7. A drape according to Claim 6, wherein said reinforcing panel is absorbent through its outer surface. 4i7ii

8. A drape according to Claim 7, wherein there is a fluid impervious element between said sheet and the reinforcing panel.

9. A drape according to Claim 8, wherein the upper surface of the reinforcing panel is secured to the fluid impervious element. •

10. A drape according to any preceding Claim, wherein each wing has a said flap attached thereto.

11. A drape according to any preceding Claim, wherein each flap is attached to its respective wing along a line adjacent the inner side edge thereof.

12. A drape according to any preceding Claim, wherein said gap comprises a curvilinear edge portion.

13. A drape according to any preceding Claim, wherein the main portion is folded to form a first stack of folds overlying a portion of said sheet, the flap on one wing being folded to overlie said wing, said wing with its said overlying flap and the other wing each being folded to form stacks of folds overlying said first stack of folds and said portion of said sheet.

14. A surgical drape substantially as described herein with reference to the accompanying drawings.

15. A drape according to any preceding Claim, treated to render it sterile and packaged in the sterile condition.