CA2325422A1

CA2325422A1 - Dispenser for roll of surgical drape material and methods of use

Info

Publication number: CA2325422A1
Application number: CA002325422A
Authority: CA
Inventors: Kimberly A. Romanko; Gerald E. Drake; Cathleen M. Arsenault
Original assignee: Individual
Current assignee: 3M Co
Priority date: 1998-03-31
Filing date: 1998-09-14
Publication date: 1999-10-07
Also published as: EP1065988A1; AU9386998A; AU748005B2; JP2002509758A; WO1999049804A1

Abstract

A dispenser for a roll of surgical drape material comprises a frame for holding the roll and a blade assembly pivotally mounted on the frame. The frame includes a side portion for partially enclosing the roll and an opening for receiving the roll. The blade assembly includes a tensioning handle and a blade for cutting a selected length of surgical drape material, and is adapted to pivot from a shielded safety position to an unshielded cutting position.

Description

DISPENSER FOR ROLL OF SURGICAL DRAPE MATERIAL
AND MET~iODS OF USE
Field of the Invention The present invention relates to dispensers for cutting and dispensing surgical drape material from a roll, and in particular to dispensers that have a movable cutting blade that pivots from a shielded safety position to a cutting position.
Background of the Invention Surgical drapes are used to limit the risk of infection during surgical procedures by covering portions of the environment surrounding the aseptic operating field, including the patient's body, that cannot be sterilized or adequately cleansed. Surgical drapes provide a sterile barrier between these non-sterile areas and the open surgical incision and thereby reduce the likelihood of infection.
Surgical drapes are typically sterile, flexible sheets of material that readily conform to the shape of any object over which they are placed.
Disposable surgical drapes are well known and are available in several different forms having various features. Disposable drapes may be absorbent or nonabsorbent, over all or part of their surfaces. They may be permeable to water vapor but impermeable to liquids. In addition, many surgical drapes have openings cut out of their surfaces to provide an uncovered area of skin on which a physician may make an incision. In contrast, other surgical drapes called incise drapes have no such openings, and the surgeon makes his incision by cutting through the fabric of the drape and the underlying skin. Drapes may include many other advantageous features, including pouches for instruments or fluid collection, loops, and absorbent pads.
Disposable drapes are usually sterilized and packaged individually or as part of a kit with other surgical items. This leads to considerable packaging expense and waste when compared with the cost that would be incurred if several drapes were packaged together. Furthermore, there is additional waste that results from the use of costly sterile drapes for medical procedures where sterility is not required. Non-sterile drapes could be used in many of these procedures with no

2 increased risk of infection. Appropriate procedures for use of non-sterile drapes would include any procedures in which a drape is needed to absorb fluid or provide a barrier to preserve cleanliness at a site that is not close to a surgical incision. For example, non-sterile drapes could be wrapped around a tourniquet that is not near a wound site to keep it clean. Non-sterile drapes could also be used to absorb fluid puddles on or near a patient's body during surgical preparation, in a location that is not near a wound site. Non-sterile drapes could also be used to keep areas and equipment that are not near a wound site clean.
These problems are addressed by U.S. Application Ser. No. 08/855,687, which provides a roll of surgical drape material of continuous length that may be used to dispense several surgical drapes of preselected length. The drape material on the roll may be either sterile or non-sterile. A dispenser with a cutting blade is provided to cut drapes from the roll. By providing several drapes in a single roll, the invention of the 08/855,687 application eliminates packaging waste that results from the industry practice of packaging individual drapes separately.
Furthermore, by providing non-sterile drapes the 08/855,687 application furnishes a method to reduce the unnecessary costs associated with using sterile drapes in non-sterile procedures.
However, there is a need for a safer dispenser for a roll of surgical drape material in the medical workplace. A drawback to using a dispenser with an unguarded or insufficiently guarded blade is that there is a risk that a physician or other medical worker may cut himself or herself on the blade during an invasive procedure and contract an infectious disease as a result. Therefore, a suitable dispenser should have a cutting blade that is sharp enough to cut through drape material but which is shielded to prevent accidental cuts to the skin.
Summary of the Invention The present invention addresses these problems by providing a dispenser for a roll of surgical drape material that has a blade assembly that pivots between a shielded safety position and an unshielded cutting position. When the dispenser is not being used for cutting drape material, a spring forces the blade assembly into the shielded safety position.

WO 99/49804 PCT/US98/190b2

3 In one aspect of the invention, the dispenser includes a frame for holding a roll of surgical drape material having a side portion for enclosing'the roll and an opening for receiving the roll. A blade assembly including a tensioning handle and a blade is pivotally mounted on the frame. The blade assembly is adapted to pivot from a shielded safety position to an unshielded cutting position when a force is exerted on the tensioning handle.
In another aspect of the invention, a spring disposed between the frame and the tensioning handle exerts a force against the blade assembly that secures the blade in the shielded safety position when the dispenser is not in use.
In yet another aspect of the invention, the frame of the dispenser further includes a hinge that allows the frame to be compressed and used to grasp the roll during cutting and dispensing.
In another aspect of the invention, there is provided a kit for dispensing surgical drape material from a roll. The kit includes a roll of surgical drape material in a dispenser made according to the invention. The dispenser comprises a frame for holding the roll and a blade assembly. The frame includes a side portion for partially enclosing the roll and an opening for receiving the roll. The blade assembly is pivotally mounted on the frame and includes a tensioning handle and a blade for cutting a selected length of surgical drape material. The blade assembly is adapted to pivot from a shielded safety position to an unshielded cutting position when a force is exerted on the tensioning handle.
In a further aspect of the invention, there is provided a method of dispensing a selected length of surgical drape material from a roll using a dispenser of the invention. The steps of the method include providing a roll of surgical drape material; providing a dispenser for surgical drape material made according to the present invention; placing the roll in the dispenser and unrolling a selected length of surgical drape material to be cut from the roll; pressing the tensioning handle toward the frame and thereby pivoting the blade into its unshielded cutting position; and cutting the selected length of surgical drape material from the roll with the unshielded blade.
In another aspect of the invention, there is provided a method of dispensing a selected length of surgical drape material from a roll using a dispenser that

4 PCT/US98/19062 includes a hinge on the frame that allows the frame to be compressed and used to grasp the roll during cutting and dispensing. The steps of the method include providing a roll of surgical drape material; providing a dispenser having a hinge on the frame that allows the frame to be compressed circumferentially; placing the roll in the dispenser and unrolling a selected length of surgical drape material to be cut from the roll; pressing the tensioning handle toward the frame and thereby pivoting the blade into its unshielded cutting position; compressing the frame to grasp the roll, and cutting the surgical drape material from the roll with the unshielded blade.
Brief Description of the Drawings The present invention will be further described with reference to the accompanying drawings, wherein like reference numerals refer to like parts in the several views, and wherein:
FIGURE 1 is a perspective view showing an embodiment of the surgical drape dispenser of the invention showing the cutting blade in the shielded safety position.
FIGURE 2 is a perspective view showing an embodiment of the surgical drape dispenser of the invention with a roll of surgical drape material inserted therein.
FIGURE 3 is a cross-sectional view showing an embodiment of the surgical drape dispenser of the invention with the blade in the shielded safety position.
FIGURE 4 is a cross-sectional view showing an embodiment of the surgical drape dispenser of the invention with the blade in the cutting position.
FIGURE S is a perspective view showing an embodiment of the surgical drape dispenser of the invention with a roll of surgical drape material inserted therein FIGURE 6 is a perspective view showing an embodiment of the surgical drape dispenser of the invention with a roll of surgical drape material inserted therein.
FIGURE 7 is a cross-sectional view showing an embodiment of the surgical drape dispenser of the invention with the blade in the shielded safety position.

S
FIGURE 8 is a cross-sectional view showing an embodiment of the surgical drape dispenser of the invention with the blade in the cutting position.
FIGURE 9 is a perspective view showing an embodiment of the surgical drape dispenser of the invention with a roll of surgical drape material inserted therein.
FIGURE 10 is a perspective view showing an embodiment of the surgical drape dispenser of the invention with a roll of surgical drape material inserted therein.
FIGURE 11 is a cross-sectional view showing an embodiment of the surgical drape dispenser of the invention with the blade in the shielded safety position.
FIGURE 12 is a cross-sectional view showing an embodiment of the surgical drape dispenser of the invention with the blade in the cutting position.
FIGURE 13 is a perspective view showing an embodiment of the surgical I S drape dispenser of the invention having a hinge on its frame.
FIGURE 14 is a cross-sectional view showing an embodiment of the surgical drape dispenser of the invention with the blade in the shielded safety position.
FIGURE 1 S is a cross-sectional view showing an embodiment of the surgical drape dispenser of the invention with the blade in the cutting position.
Detailed Description of the Invention The surgical drape dispenser of the invention is used to dispense surgical drape material from a roll of continuous length. The surgical drape material may 2S be of any type that can be wound onto a roll, and it may be sterile or non-sterile.
The continuous length rolls may be of any desired length, but preferably are long enough to provide several drapes. The surgical drape material may include any of the features commonly found in disposable surgical drapes. For instance, it may include openings or fenestrations through which a surgeon can make an incision.
Or in the case of an incise drape, it may include adhesive on one side to adhere the drape to the surface of a patient's skin. The drape material may also include pockets or loops for holding instruments, tools, fluid bags, absorbent pads or other WO 99!49804 PCT/US98/19062 6 .
such items that are useful in medical procedures. In addition, the drape material on the roll may have perforations or score lines to provide a guide for selecting an appropriate drape length. Furthermore, the drape material may be folded widthwise before being wound onto the core so that the drape can be expanded to a width greater than that of the roll after being cut.
Figures 1-4 illustrate a preferred embodiment of the surgical drape dispenser 10 of the invention. Figure 1 shows the dispenser 10 without a roll of drape material inserted therein so that all parts of the dispenser may be readily illustrated and described. Figure 2 shows the dispenser 10 with a roll 40 of continuous length drape material inserted therein, as it would appear when used.
The dispenser 10 includes a frame 30 for holding a roll 40 of drape material and a blade assembly 20 pivotally mounted on the frame 30 for cutting preselected lengths of drape material for use as surgical drapes. The frame 30 has a side portion 32 that is designed to partially enclose the roll 40 of drape material and an opening 12 for placing the roll within the frame 30. The frame 30 also includes end pieces 34, which are associated with core tabs 36 and core retention rings 38.
The core tabs 36 are flexible to allow the roll 40 to be inserted between them against a preloaded force, which then retains the roll 40 snugly within the frame 30. Core retention rings 38 are sized and shaped to fit within the inner circumference of the roll core to prevent the roll core from slipping out of the frame 30. In an alternative embodiment, the core retention rings 38 may be sized to receive the roll core within their inner diameters and thus retain the roll within the dispenser 10.
The blade assembly 20 is pivotally mounted on the frame 30 by means of pivoting hubs 28 on both end pieces 34 of the frame 30. The blade assembly 20 includes a tensioning handle 22 and a blade 24. The blade assembly 30 pivots around the hubs 28 and thereby rotates the blade 24 from a guarded safety position, shown in fig. 3, wherein the cutting surface of the blade 24 is shielded by blade guard 26, to an unguarded cutting position, shown in fig. 4, wherein the blade is exposed so that it may be used for cutting drape material. A spring 44 is disposed between the side portion 32 of the frame 30 and the tensioning handle 22. The spring 44 exerts a force on the blade assembly 20 that secures the. blade 24 in the guarded safety position when it is not being used.
To dispense a surgical drape using the dispenser 10, a roll 40 of surgical drape material is inserted in the dispenser 10 through opening 12 and placed S between end pieces 36. Core retention rings 38 are seated in the ends of the cores of the roll 40 to prevent slippage. The user then advances the leading edge 42 of the roll 40 a distance calculated to provide a drape of a desired length. The user then depresses tensioning handle 22, which compresses spring 44 against the side portion 32 of the frame 30 and thereby rotates the cutting blade 24 from the shielded safety position, shown in figure 3, to the unguarded cutting position shown in figure 4. The drape material is then pulled back against the exposed blade 24 to cut the drape from the roll 40. After the drape has been cut, the tensioning handle 22 is released, and spring 44 exerts a force against the blade assembly 20 that rotates the blade 24 back into the guarded safety position shown in figure 3.
The frame 30 and the tensioning handle 22 may be readily constructed of polymeric materials using well-known techniques and methods. The frame 30 may suitably be made in any size necessary to accommodate a roll 40 of drape material having any desired width. In a preferred embodiment, the blade 24 and side portion 32 are between 4 inches and 36 inches long. In a more preferred embodiment, they are between 4 and 24 inches long. In the most preferred embodiment, they are between 4 and 18 inches long. The frame 30 may be made in any shape that will receive and store a cylindrical roll of material. However, the frame 30 is preferably contoured to match the shape of the roll 40, and most preferably is semi-cylindrical in shape.
The blade 24 may preferably be made of any material capable of providing a sharp cutting edge. The blade 24 is most preferably made of metal. In a preferred embodiment, the blade 24 is straight planar as shown in figure 1. In the most preferred embodiment of the invention, the blade is serrated as shown in the blade 124 of figure 5.
The spring 44 used in the dispenser 10 may be made of any material having sufficient resilience and flexibility to generate the force necessary to rotate the blade assembly 20 and hold the blade 24 securely against the blade guard 26 in the shielded safety position. The spring 44 may be any type of spring.including, by way of nonlimiting example only, a leaf spring or a coil spring. The spring 44 may-be attached at one end to either the side portion of the frame 32 or the tensioning handle 22. In an alternative embodiment, the spring 44 may be attached to both the side portion 32 and the tensioning handle 22. In another alternative embodiment, the spring 44 may not be attached to either the side portion 32 or the tensioning handle 22, but may instead occupy a position between the two. More than one spring may be used in the dispenser of the invention.
In a preferred embodiment of the dispenser I O shown in figures 3-4, the spring 44 is a leaf spring affixed at one end to the side portion 32 of the frame 30.
The spring 44 may be polymeric and may preferably be made of the same material as the frame 30. When the spring 44 is polymeric, it may be made separately from the frame 30 or cast from the same die as frame 30 as an integral part of the frame 30. In this embodiment the spring 44 is most preferably made of polymeric material.
In an alternative embodiment of the dispenser 110, shown in figures S-8, the spring 144 is a leaf spring that is folded and disposed between the side portion 132 of the frame 130 and the tensioning handle I22. The spring 144 in this embodiment is most preferably made of metal. Figure 7 shows the dispenser 110 with the blade I24 in the shielded safety position, abutting glade guard 126.
The dispenser 110 is shown in the unshielded cutting position with the spring 144 compressed in figure 8.
In another alternative embodiment of the dispenser 210, shown in figures 9-12, two leaf springs 244 are used to hold the blade 224 in the shielded safety position when it is not being used for cutting. As an additional safety feature, there is provided a locking tab 270 to lock one or both of the springs 244 into place and prevent the blade 224 from unintentionally rotating into the unshielded cutting position shown in figure 11. The tab 270 may be a detented tab that moves between a protruding position and a recessed position. As shown in figure 11, in the protruding position tab 270 prevents the spring 244 from being compressed and thereby locks the blade 224 in the shielded safety position. When the tab 270 is recessed, as shown in figure I2, the spring 244 may be compressed and the blade rotated into the cutting position. In an alternative embodiment, not shown, the locking tab may be a sliding tab that moves from a locking position in which it blocks the compression of the spring to a cutting position in which the spring may be compressed freely.
As best shown in figure 6, the dispenser 110 of the invention may also include a handle 150 on the frame 130 to be used to firmly hold the dispenser while it is being used to dispense surgical drape material.
Figures I 3-15 show yet another embodiment of the dispenser 310 of the invention that includes as an additional feature a hinge 380 on frame 330 that is perpendicular to the end pieces 334. The hinge 380 is preferably constructed of a flexible polymeric material that allows the user of the dispenser to circumferentially compress the frame 330 by squeezing the frame 330 on both sides of the hinge 380. In this manner the dispenser 310 may be used to grasp the I S roll 40 firmly while dispensing the drape material. In the most preferred embodiment of the invention the hinge 380 is a living hinge.
An alternative configuration of the blade 324 is also provided as part of the dispenser 310. The blade 324 is angled so that when it is in the shielded safety position, shown in figure 14, the edge of the blade points toward the interior wall of side portion 332 of the frame 330. When the blade 324 is rotated into the unshielded cutting position, shown in figure 15, the blade 324 contacts the top surface of the roll 340. This configuration of the blade 324 provides an additional margin of safety because the cutting surface of the blade 324 is never openly exposed, even when the blade is in the unshielded cutting position. The likelihood of a user accidentally cutting himself or herself on the blade is therefore further reduced when blade 324 is used. Although blade 324 is shown with reference to the particular embodiment illustrated in figures 13-15, it will be understood that this configuration may be used in any of the embodiments of the invention.
To dispense a surgical drape using the dispenser 310, a roll of surgical drape material 340 is placed within the dispenser 310 between the two end pieces 334, and the core retention rings 338 are inserted into the core of the roll 340 to hold it firmly in place during the dispensing operation. While holding the WO 99/49804 PC'T/US98/19062 dispenser 310 in one hand, the user pulls the leading edge 342 of the roll 340 a distance calculated to provide a drape of a selected size. The user then compresses the frame 330 to grasp the roll 340 during the dispensing operation. When the roll 340 is grasped in this fashion, the blade 324, which is still in the shielded safety

5 position in figure 14, is pushed closer to the roll 340. The spring 344 is then compressed with the tensioning handle 322 and the blade 324 is rotated into the cutting position shown in figure 15. The drape is then cut from the roll by pulling the drape material against the blade 324.
The present invention has now been described with reference to several 10 embodiments thereof. The foregoing detailed description and examples have been given for clarity and understanding only. No unnecessary limitations are to be understood therefrom. It will be apparent to those skilled in the art that many changes can be made in the embodiments described without departing from the scope of the invention. Thus, the scope of the present invention should not be limited to the exact details and structures described herein, but rather by the structures described by the language of the claims, and the equivalents of those structures.

Claims

WHAT IS CLAIMED IS:

1. A dispenser for surgical drape material on a roll, comprising:
(a) a frame fur holding the roll including a side portion for partially enclosing the roll and an opening for receiving the roll; and (b) a blade assembly pivotally mounted on the frame including a tensioning handle at one end and a blade for cutting a selected length of surgical drape material at the other end, the blade assembly being adapted to pivot from a shielded safety position to an unshielded cutting position when a force is exerted on the tensioning handle.

2. The dispenser of claim 1, further comprising (c) a spring that secures the blade in the shielded safety position when the spring is not compressed.

3. The dispenser of claim 2, wherein the spring is disposed between the frame and the tensioning handle.

4. The dispenser of claim 2, further comprising 2 or more springs.

5. The dispenser of claim 2, wherein the dispenser further comprises a movable locking tab having a first position wherein the tab hinders the compression of the spring and a second position wherein the tab allows the spring to be compressed.

6. The dispenser of claim 4, wherein the dispenser further comprises a movable locking tab having a first position wherein the tab hinders the compression of at least one of the springs and a second position wherein the tab allows the spring to be compressed.

7. The dispenser of claim 1, wherein the frame further comprises a hinge that allows the frame to be compressed and used to grasp the roll during cutting and dispensing.

8. A kit for dispensing surgical drapes, comprising:
a roll of surgical drape material and a dispenser according to any one of the preceding claims.

9. Use of a dispenser according to any one of claims 1 to 7 for surgical drape material on a roll.