Sterile Radiological Drape

Abstract

Systems and methods for a sterile radiological drape designed to isolate the non-sterile portions of medical equipment used during surgery from the sterile zone adjacent to where medical procedures are performed are described. In one embodiment the flexible sterile drape enclosure may be incorporated into the patient drape allowing for protection and draping of both the patient and the medical equipment. In another embodiment the drape comprises a board with a hole formed therein and a sterile enclosure mounted thereto atop of a Mayo stand. This hole allows for the medical equipment to rotate into the sterile enclosure in close proximity with the sterile zone without contaminating it. The systems and methods provide advantages in that the sterile drape is easy to apply and may be moved multiple times during the surgery, which reduces the length of a medical procedure as well as the cost associated therewith.

Claims

1. A sterile imaging drape for use on a piece of medical equipment to preserve a sterile field of an operating theater comprising: a flexible enclosure attached to an operating table including: a proximal end mounted to the operating table; a distal end, opposite the proximal end; an outer upper portion between the proximal and distal ends; and an inner medical equipment shielding portion, opposite the outer upper portion wherein the flexible enclosure can repeatedly be moved between; an expanded configuration where the flexible enclosure encloses at least a portion of the piece of medical equipment; and a collapsed configuration where the outer upper portion of the flexible enclosure is folded inwardly to substantially shield the outer upper portion from external contamination; and at least one reusable enclosure fastener disposed adjacent at least one of said proximal and distal ends to secure the enclosure in the collapsed configuration.

2. The sterile imaging drape of claim 1, wherein the flexible enclosure further comprises: a patient drape portion configured to cover at least a portion of a patient resting on the operating table; and a medical equipment drape portion having the proximal end and the distal end configured to cover the piece of medical equipment in the expanded configuration and configured to shield the outer upper portion in the collapsed configuration.

3. The sterile imaging drape of claim 2, wherein the medical equipment drape portion is made of a transparent plastic material and the patient drape portion is made of an absorbent draping material.

4. The sterile imaging drape of claim 1, further comprising an isolation drape extending from the flexible enclosure that separates the operating table from the piece of medical equipment.

5. The sterile imaging drape of claim 4, further comprising: at least one stand supporting the isolation drape; and a pocket formed in a bottom surface of the isolation drape; wherein the pocket is configured to receive a portion of the piece of medical equipment.

6. The sterile imaging drape of claim 5, wherein the at least one stand comprises a first vertical stand and a second vertical stand; wherein the isolation drape is vertical isolation drape supported by the first vertical stand and the second vertical stand; wherein the flexible enclosure is the pocket; and wherein a portion of the piece of medical equipment extends beneath the isolation drape into the pocket.

7. The sterile imaging drape of claim 6, wherein the distal end of the pocket can be moved: to the expanded configuration to accept the portion of the piece of medical equipment; and to the collapsed configuration when the portion of the piece of medical equipment is removed from the pocket.

8. The sterile imaging drape of claim 1, further comprising at least one manipulable strip near the distal end forming a collapsible integrated tenting feature.

9. The sterile imaging drape of claim 8, wherein the at least one manipulable strip comprises an aluminum strip that is bendable to hold the flexible enclosure at table height.

10. The sterile imaging drape of claim 1, further comprising adhesive mounted adjacent to the distal end configured to mount the flexible enclosure to an operating table.

11. The sterile imaging drape of claim 10, further comprising an accordion folding sidewall allowing for the sidewall and the outer upper portion to fold and be disposed to substantially shield the outer upper portion from external contamination.

12. The sterile imaging drape of claim 1, further comprising: a board connected to the flexible enclosure and mounted adjacent to the operating table; and an opening formed in the board; wherein at least a portion of the piece of medical equipment is moveable through the opening into the flexible enclosure to shield the outer upper portion.

13. The sterile imaging drape of claim 12, wherein the board is mounted to a Mayo stand.

14. The sterile imaging drape of claim 12, further comprising a reinforced hoop surrounding the opening; wherein the flexible enclosure extends from the hoop in the expanded configuration; and wherein the flexible enclosure folds into the hoop in the collapsed configuration.

15. The sterile imaging drape of claim 12, further comprising a sterile tube extending beneath the operating table; wherein the portion of the piece of medical equipment travels through the sterile tube, through the opening, and into the flexible enclosure.

16. A method of draping an operating room comprising the steps of: affixing a flexible enclosure to an operating table, the flexible enclosure including: a proximal end mounted to the operating table; a distal end, opposite the proximal end; an outer upper portion between the proximal and distal end; and an inner medical equipment shielding portion, opposite the outer upper portion; moving the flexible enclosure to an expanded configuration where the flexible enclosure encloses at least a portion of the piece of medical equipment; moving the flexible enclosure to a collapsed configuration where the outer upper portion of the flexible enclosure is folded inwardly to substantially shield the outer upper portion from external contamination; and securing the flexible enclosure in the collapsed configuration using at least one reusable enclosure fasteners.

17. The method of claim 16, further comprising the steps of: securing a patient drape portion of the flexible enclosure over a patient resting on the operating table; and securing a medical equipment drape portion adjacent to an end of the operating table where a portion of the piece of medical equipment is moved.

18. The method of claim 16, further comprising the steps of: installing at least one stand adjacent to the operating table; affixing an isolation drape having a pocket formed therein to the at least one stand; and moving a portion of piece of medical equipment into the pocket.

19. The method of claim 16, further comprising the steps of: moving the flexible enclosure to the expanded configuration; and manipulating at least one manipulable strip formed in the distal end to support the flexible enclosure.

20. The method of claim 16, further comprising the steps of: installing a board having an opening formed therein with the flexible enclosure extending therefrom adjacent to the operating table; moving a portion of the piece of medical equipment relative to the operating table; moving the portion of the piece of medical equipment through the opening; and moving the portion of the piece of medical equipment into the flexible enclosure.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0025] A clear conception of the advantages and features constituting the present invention, and of the construction and operation of typical mechanisms provided with the present invention, will become more readily apparent by referring to the exemplary, and therefore non-limiting, embodiments illustrated in the drawings accompanying and forming a part of this specification, wherein like reference numerals designate the same elements in the several views, and in which:

[0026] FIG. 1 illustrates a perspective view of a sterile drape incorporated into a patient drape with a piece of medical equipment expanding a flexible sterile enclosure, in accordance with the present invention.

[0027] FIG. 2 illustrates a perspective view of a sterile drape suspended from two stands to form an isolation wall with the lower portion comprising a flexible sterile enclosure, where the sterile drape is in an initial position, in accordance with the present invention.

[0028] FIG. 3 illustrates a perspective view of the sterile drape suspended from two stands of FIG. 2, where the sterile drape is in an expanded position, in accordance with the present invention.

[0029] FIG. 4 illustrates a perspective view of a sterile drape with an integrated tenting feature consisting of aluminum strips expanding the flexible sterile enclosure, in accordance with the present invention.

[0030] FIG. 5 illustrates a low cost sterile drape for use to with a movable piece of medical equipment.

[0031] FIG. 6 illustrates a perspective view of a sterile drape which disposes into the sterile field in an accordion folding manner

[0032] FIGS. 7A and 7B illustrates perspective views of a sterile drape forming an enclosure mounted to a board and secured under the operating table pad, in accordance with the present invention.

[0033] FIG. 8 illustrates a perspective view of a sterile drape forming an enclosure mounted to a Mayo stand, in accordance with the present invention.

[0034] FIG. 9 illustrates a perspective view of the sterile drape mounted to the Mayo stand for FIG. 8, where medical equipment is moved into the enclosure, in accordance with the present invention.

[0035] FIG. 10 illustrates a perspective view of a sterile drape stored in a hoop on a Mayo stand, in accordance with the present invention.

[0036] FIG. 11 A-E illustrate a side view of a sterile drape forming a sterile tube extending from below the operating table and mounted to a board which is secured under the operating table pad, in accordance with the present invention.

[0037] FIG. 12 illustrates a side view of a drape system wherein a plurality of flexible sheet enclosures is mounted on top of one another and secured around the medical equipment, in accordance with the present invention.

[0038] FIG. 13 Illustrates a perspective view of the drape system wherein a plurality of flexible sheet enclosures is stored on a roll, in accordance with the present invention.

[0039] FIG. 14 illustrates the method using a sterile drape, in accordance with the present invention.

[0040] In describing the preferred embodiment of the invention which is illustrated in the drawings, specific terminology will be resorted to for the sake of clarity. However, it is not intended that the invention be limited to the specific terms so selected and it is to be understood that each specific term includes all technical equivalents which operate in a similar manner to accomplish a similar purpose. For example, the word connected, attached, or terms similar thereto are often used. They are not limited to direct connection but include connection through other elements where such connection is recognized as being equivalent by those skilled in the art.

DESCRIPTION OF PREFERRED EMBODIMENTS

[0041] The present invention and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments described in detail in the following description.

[0042] As shown in the figures, the present invention is directed to a sterile radiological drape 20 for use during surgical procedures. This sterile radiological drape 20 helps to maintain sterility about an operating theater 26 while various medical equipment 22 is moved about an operating table 32. For instance, the drape 20 can be used with imaging devices, which enables easy transition between surgery and radiological imaging during medical procedures. The sterile radiological drape 20 allows for multiple uses of unsterilized medical equipment 22 without contaminating the sterile field 24. Preferably, the sterile radiological drape 20 can be easily and affordably manufactured, while also being of high quality and durability. Various non-limiting embodiments of drapes that fulfill these requirements will be further described below. Any of the features associated with any of these embodiments may be combinable with any of the other embodiments shown herein.

[0043] In many of the embodiments described below, the sterile radiological drape 20 may include a proximal end 29 and distal end 31 with a flexible sterile enclosure 28 therebetween. Furthermore, the drape 20 may include an inner medical equipment shielding portion 34 and an outer upper portion 36. The inner medical equipment shielding portion 34 need not be sterile, and repeatedly can come into contact with the medical equipment 22. The sterile drape 20 which may attach to the operating table 32 by way of adhesive strips or fasteners (not shown).

[0044] Additionally, the drape 20 may include reusable enclosure fasteners 38 on both the proximal end 29 and distal end 31 that allow the drape 20 to move back and forth between expanded and collapsed positions. More specifically, when in the expanded position the drape 20 is designed to be sufficiently sized to receive and cover at least a portion of the unsterilized medical equipment 22, such as an unsterilized imaging unit. When this occurs, the equipment 22 may be housed within the enclosure 28 and abut against the inner medical equipment shielding portion 34. When the drape 20 is returned to the collapsed position, the proximal end 29 and the distal end 31 are brought together, and the outer upper portion 36 of the enclosure is folded inwardly such that the outer upper portion 36 is substantially shielded from external contamination, such as from external objects or the non-sterile surfaces of the enclosure itself. The drape 20 may be an accordion-style drape that is mounted to the edge of the operating table 32.

[0045] Preferably, the drape 20 can be either expanded or collapsed repeatedly in an expedited manner to improve efficiency. For instance, in one embodiment, the drape 20 can be expanded or collapsed in less than thirty seconds. More preferably, the drape 20 can be expanded or collapsed in less that fifteen seconds. Even more preferably, the drape can be expanded or collapsed in less than two seconds.

[0046] In many of the illustrated embodiments, the drape 20 is symmetrical. However, the drape 20 could similarly be asymmetrical. For instance, the drape 20 may be asymmetrical in order to adequately and securely cover a specific piece of medical equipment. Furthermore, while the figures show a number of different drapes having a number of different dimensions and shapes, the specific shape and size of the drape 20 could vary significantly depending on a number of different factors, such as the medical equipment 22 it is designed to cover, the size of the operating theater 26, the specific medical procedure being performed, and the like.

[0047] Turning now to the embodiment shown in FIG. 1, the sterile radiological drape 20 is integrated with a patient drape 21. In doing so, a single drape can easily be installed onto the patient 30 and operating table 32 before the medical procedure commences. The integrated sterile radiological drape 20 and patient drape 21 could be manufactured together or manufactured separately and later secured to one another. Additionally, the integrated sterile radiological drape 20 and patient drape 21 can be folded in such a way as to simplify the process of unwrapping and installing it to the patient 30 and operating table 32 while maintaining sterility about the operating theater 26. Alternatively, the patient 30 may be draped after the possible contamination of an adjacent piece of medical equipment 22 to avoid exposing the patient to the possible contamination. The sterile radiological drape 20 portion could be made of the same material as the patient drape 21, or it could be made of different materials. For instance, all portions could be made of an absorbent blue draping material. Alternatively, the sterile radiological drape 20 portion could be made of a transparent plastic material and the patient drape could be made of an absorbent blue draping material. The material may also be coated with an anti-microbial substance.

[0048] Moving on to FIGS. 2 and 3, the drape 20 could take the form of an isolation drape. More specifically, as shown in initially in FIG. 2, the drape 20 may include a portion that serves as a vertical isolation drape 37 that separates the operating table 32 and the patient 30 from the exterior of the isolation drape 37, and a pocket 27 formed in the bottom of the isolation drape 37. The isolation drape 37 can extend vertically between two stands 41, which help to form an isolation drape. The pocket 27 may be configured to accept various medical equipment 22 when the medical equipment 22 is moved past the isolation drape 37. For instance, the drape 20 may be used in connection with an X-ray tube. In this embodiment, the lower half of the drape 20 has the pocket 27 into which the medical equipment 22 is raised when in use. More specifically, the pocket 27 can be manipulated when the medical equipment 22 is moved outside of the isolation drape 37. When the pocket 27 is manipulated, it can be opened such that the medical equipment 22 is located therebeneath to maintain sterility about the operating theater 26. Additionally, the drape 20 and/or pocket 27 may be made of, or include, absorbent materials to help absorb any liquids that enter the drape 20 or the pocket 27. Further still, a drain (not shown) may be formed in the center to control the location with which liquids exit the drape 20 and/or pocket 27.

[0049] Turning next to FIG. 4, another embodiment is shown in which the drape 20 may include various components to facilitate various tenting effects, including an integrated tenting feature 33. In the illustrated embodiment, the integrated tenting feature 33 of the drape 20 includes at least one bendable strip 42 is incorporated with a portion of the drape 20. For instance, the bendable strip 42 may be a malleable aluminum strip that can easily be bended, but thereafter holds its shape. Of course, the bendable strip 42 could similarly be made of other malleable materials. This would allow a user to adjust the strip 42 in a specific location such that the drape 20 will retain a position shape or configuration. For instance, a user could position the strip 42 such that the drape 20 would be suspended at table height and for the medical equipment 22 to be rotated in and out of the pocket 27. As shown, the bendable strip 42 is located on the distal end 31 of the drape 20, such that the bendable strip 42 can be positioned when the drape 20 is in an expanded configuration. More specifically, when the drape 20 is moved to the expanded position, the bendable strip 42 can be bent to ensure that the drape 20 remains secured around the medical equipment 22 until the medical equipment 22 is returned to its original position, in which case the bendable strip 42 can be moved away from the medical equipment 22. The tenting feature may be collapsed, which in turn would allow the drape 20 to be collapsed as described above.

[0050] In yet another embodiment, a drape 20 may be desired that can be affordably manufactured. For instance, one such drape 20 is shown in U.S. Design patent application Ser. No. 29/649,813, which is incorporated herein by reference in its entirety and attached hereto. An image of the affordable, low-cost drape 20 is shown in FIG. 5, which shows the drape 20, including the proximal end 29, the distal end 31, the inner medical equipment shield portion 34, and the outer upper portion 36, as well as the reusable enclosure fasteners 38, in isolation. Such a drape 20 may provide 5-sided protection to ensure sterility is maintained about the patient 30 and the operating table 32.

[0051] Looking now at FIG. 6, another embodiment is shown in which the drape 20 is shown having many of the same component parts listed above, with the addition of features that allow the drape 20 to fold in an accordion-style manner 35. As shown, the accordion folding style 35 allows the outer upper portion 36 to collapse in on itself so as to not contact the inner medical equipment shielding portion 34, thus preserving sterility to the sterile field. The accordion folding style 35 of the drape 20 helps to ensure that the sidewalls 39 fold inwardly to maintain sterility outside of the drape 20 while components located inside the drape 20, including the medical equipment 22, may not be sterile. This allows the medical equipment 22 to be safely moved about the operating theater 26 without subjecting the patient to non-sterile conditions. Again, the drape 20 may be repeatedly moved from an expanded configuration as shown in FIG. 6 to a collapsed position when the medical equipment 22 is moved away from the operating table 32.

[0052] Other components could also be used with the drape 20 to help maintain sterility of about the operating theater 26 while the medical equipment 22 is moved. For instance, as shown in FIGS. 7A and 7B, the sterile drape 20 may also form an enclosure 28 which may be mounted to a board 54. These figures show the drape 20 when the medical equipment 22 is moved within the enclosure 28. The board 54 may be made of a thin, durable material to provide added rigidity to the drape 20 system. The board 54 may be secured under the operating table pad 58 and may have a bottom opening 56 or hole through which the medical equipment 22 can pass through to enter the sterile enclosure 28. While the illustrated embodiments include a substantially square-shaped board 54 with a circular opening 56 formed therein, both the board 54 and the opening 56 may be in different configurations depending on a number of factors, including the size and shape of the medical equipment 22, the desired movements of the medical equipment 22, the medical procedures being performed, the size of the operating table and theater 26, 32, and the like. As shown, the board 54 will remain in place relative to the operating table 32, and the medical equipment 22, such as an imaging tube 64, can be repeatedly be moved through and out of the opening 52 into and out of the enclosure 28. The sterile drape 20 may be clear to allow for observation of the imaging tube 64 as it interacts with the patient 30.

[0053] Turning next to FIGS. 8 and 9, another similar embodiment is provided, that also includes a board 54 with an opening 56 extending therethrough. However, the board is mounted to a Mayo stand 50. For instance, FIG. 8 shows the drape 20 system in an initial position before it is installed adjacent to the operating table 32 and before the medical equipment 22 is moved into the enclosure 28. First, the drape 20 system is moved adjacent to the operating table 32. Thereafter, when the medical equipment 22 is moved from a first position to a second position, it can be moved into the enclosure 28 as shown in FIG. 9. When this occurs, the medical equipment 22 moves through the bottom opening or hole 56 into the sterile enclosure 28. Again, the medical equipment 22 can be repeated moved into and out of the enclosure 28 without compromising sterility of the drape system.

[0054] In yet another embodiment shown in FIG. 10, the sterile drape 20 may be stored in a hoop 60 position atop the hole 52, 56 in the board 54 or Mayo stand 50. Alternatively still, the hoop 60 may be used with the drape 20 in the absence of a board 54 or Mayo stand 50. Again, the hoop 60 provides structural rigidity to the drape 20 system. As the medical equipment 22 is rotated into the sterile field 24 it passes through the hoop 60 and expands the sterile drape 20. As the medical equipment 22 is rotated out of the sterile field 24 the sterile drape 20 collapses back into the hoop 60. Of course, the hoop 60 may be mounted to the table 32 or any other device in the operating theater 26.

[0055] In still another similar embodiment shown in FIGS. 11A-11E, the sterile drape 20 may again include to a board 54 with a sterile tube 62 extending therebeneath for the medical equipment 22 to pass through in a telescoping manner. More specifically, a sterile tube 62 may extend beneath the operating table 32 to provide a clear path for the medical equipment 22 to follow when it is moved about the operating theater 26, and more specifically, beneath the table 32. The board 54 may be secured under the operating table pad 58 and the sterile tube 62 may extend from below the table to table-height. The opening 56 in the board 54 may be covered with a transparent layer 57 and a blue poly layer 59. Again, this would allow for the piece of medical equipment 22 to move about the operating theater 26 while maintaining sterility about the patient 30 and operating table 32. For instance, FIG. 11A shows the drape 20 in an initial position before the medical equipment 22 is moved, and where the blue poly layer 59 is intact. FIG. 11B shows the medical equipment 22 being moved along the sterile tube 62 towards the board 54. FIG. 11C shows the medical equipment 22 moving upwardly past the board, in which the blue poly layer 59 is separated, and the transparent layer 57 surrounds the medical equipment 22 and moves upwardly with the transparent layer 57 to ensure the medical equipment 22 is fully sounded, and thus not capable of compromising sterility about the operating theater 26. FIG. 11D also shows a side view of the drape 20 system once the medical equipment 22 has moved through the board 54. Finally, FIG. 11E shows the medical equipment 22 after it is returned through the sterile tube 62 beneath the operating table 32.

[0056] In other embodiments, a drape system 67 may be provided having include multiple sheets of material. For instance, the sterile drape system 67 may include a plurality of flexible sheet enclosures 66 that are disposable. As seen in FIG. 12, a plurality of flexible sheet enclosures 66 are used to cover a piece of medical equipment 22 such as an x-ray tube. Any time the piece of medical equipment 22 is returned to an opposite side of the operating table 32, the flexible sheet enclosure 66 that contacted the piece of medical equipment 22 can be removed and disposed of so that a new sheet is on the outer surface of the medical equipment 22 once it is rotated back relative to the operating table 32. For instance, the flexible sheet enclosures 66 may be dome bags or sheets. Additionally, the flexible enclosure 66 may be ripped or teared apart from the remaining flexible enclosure 66. To further facilitate the separation of flexible enclosures from the system 67, various perforations may be provided.

[0057] On a similar note, FIG. 13 provides drape system with a dispenser roll 68 on which multiple flexible sheet enclosures 66 may be mounted. As shown, the dispenser roll 68 may be attached to the operating table 32. The flexible sheet enclosure 66 may be drawn from the roll 68 to cover the medical equipment 22 and then torn from the roll 68 and disposed of once the medical equipment 22 is moved. Each time the medical equipment 22 is rotated into the sterile field 24 the medical equipment 22 is covered with a new sterile drape 20 from the roll 68. Additionally, the roll 68 may include a spring 70 such that the roll 68 is spring-loaded for ease of dispensing. The system 67 may also include various sterile towels (not shown).

[0058] Although the above discussion has focused exclusively on the design and features of the device itself, the current invention is also directed to a method of draping an operating theater/room 26 during a surgical procedure requiring imaging that uses the unique features of the inventive drape. For instance, as shown in FIG. 14, in a first step 74, the sterile drape 20 is to be spread on the floor of the operating theater 26 to begin creating a sterile barrier. In the second step 76, the sterile drape 20 may then be spread underneath the operating table 32, thus forming a separate sterile field under the operating table 32. This additional sterile field 24 could eliminate the need for systems that require disposing of multiple drapes each time the medical equipment 22 enters the sterile field 24 by converting the majority of the operating theater into a sterile field 24. Thus, costs and time required for surgery can be reduced.

[0059] Additionally, various manufacturing and packaging processes may be implemented to improve the efficiency of creating the sterile imaging drape 20. For instance, an electronic UV light (not shown) may be used to decontaminate the drape 20. Similarly, a specific method of manufacture can be implemented that is predictable and reproducible, thereby decreasing variance and operating costs. Further still, a method may be implemented ease the simplicity of setup, manufacture, and packaging of the drape 20. On a related note, the drape 20 may be packaged in a way to help ensure that sterility is maintained while the drape is unfolded and applied to the operating table 32.

[0060] Although the best mode contemplated by the inventors of carrying out the present invention is disclosed above, practice of the present invention is not limited thereto. It will be manifest that various additions, modifications and rearrangements of the features of the present invention may be made without deviating from the spirit and scope of the underlying inventive concept. For example, any of the specific aspects of any of the described embodiments could similarly be used with any of the other embodiments. Furthermore, while specific materials have been described, it should be known that any materials could used to create any of the described drapes. For instance, materials may be chosen based on any number of criteria, including costs, availability, and various sterility properties. Moreover, as described above, the individual components need not be formed in the disclosed shapes, or assembled in the disclosed configuration, but could be provided in virtually any shape, and assembled in virtually any configuration. Further, any of the components can be manufactured with one another or be separately manufactured and later assembled. Furthermore, all the disclosed features of each disclosed embodiment can be combined with, or substituted for, the disclosed features of every other disclosed embodiment except where such features are mutually exclusive.

[0061] It is intended that the appended claims cover all such additions, modifications and rearrangements. Expedient embodiments of the present invention are differentiated by the appended claims.