WO2011041665A2

WO2011041665A2 - Sterile inflatable drape

Info

Publication number: WO2011041665A2
Application number: PCT/US2010/051105
Authority: WO
Inventors: Eric Ross Henderson
Original assignee: University of South Florida; University of South Florida St Petersburg
Current assignee: University of South Florida; University of South Florida St Petersburg
Priority date: 2009-10-01
Filing date: 2010-10-01
Publication date: 2011-04-07
Anticipated expiration: 2012-04-01
Also published as: WO2011041665A3

Abstract

A sterile inflatable drape includes a base having a size and shape adapted to cover a surgical site. A peripheral border surrounds the base. The base and the peripheral border have a first side covered with a releasable adhesive adapted to releasably engage a patient's skin when the base and peripheral border are placed over the surgical site prior to an incision. An expandable housing is mounted to a second side of the border in surrounding relation to the base and a hollow interior is defined by a space between the base and the expandable housing. An air purifier having an outlet is connected in fluid communication with the hollow interior and an air pump is in fluid communication with an inlet of the air purifier. The expandable housing expands to a predetermined shape that at least partially encloses a patient when purified air is introduced into the hollow space.

Description

STERILE INFLATABLE DRAPE

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of provisional application number 61 /247,790 of the same title filed on October 1 , 2009 by the same inventor and claims priority thereto. Said provisional application is incorporated herein by reference. BACKGROUND OF THE INVENTION

FIELD OF THE INVENTON

This invention relates to surgical drapes. More particularly, it relates to a surgical drape that includes a sterile membrane that is inflated over a surgical site.

DESCRIPTION OF THE PRIOR ART Avoidance of post-surgery infection is one of the most important goals of the health care industry. Although infection can follow any surgery, it is particularly troublesome in surgical procedures involving implantation of artificial devices. Such devices may provide surfaces that allow bacteria to evade both host defenses and modern antimicrobial therapy. Anti-infection strategies include instrument sterilization, sterile gowns, sterile gloves, hairnets, as well as the modern 'space suit' worn by joint replacement surgeons and assistants to minimize contamination of the wound and staff exposure to the patient's bodily fluids.

Bacteria are small enough to be transported through air. Accordingly, attempts have been made to create operating rooms that use laminar flow' technology where air entering the operating space is cleaned. The clean air flows in a linear path across the room and exits through a vacuumed vent. However, this requires closing down an operating room, thereby interrupting the cash flow of the hospital, and an expensive conversion of the conventional operating room to a laminar flow room. Several embodiments of laminar flow devices have been developed. However, the cost of these special rooms is substantial, and installation of the working parts, which are not portable, is time-consuming. For these reasons, such special operating rooms are not in widespread use.

The cost of infection treatment, particularly for patients with joint replacements, is substantial. Thus there is a need for a device that lowers the risk of infections at a cost that is significantly less than the cost of treating an infection. SUMMARY OF INVENTION

The novel surgical drape includes a sterile membrane that is adhered in surrounding relation to a surgical site on a patient's body. An expandable housing is attached to or formed integrally with the sterile membrane and purified air is introduced under pressure into a space defined by the sterile membrane and the expandable housing to cause the expandable housing to inflate over the surgical site. At least one viewing portal is formed in the expandable housing to enable a surgeon external to the interior of the expanded housing to see thereinto. Hand and arm portals having interlocks that prevent exterior air from entering into the interior of the expanded housing are also provided so that surgical procedures may be performed. The device is light-in-weight and portable. Accordingly, it has utility in conventional operating rooms, emergency units, as well as in the field where no operating room is available.

More particularly, the novel sterile inflatable drape includes a base having a size and shape adapted to cover a surgical site. The surgical site is defined as the area of the patent that will include an incision and an area contiguous to said incision.

A peripheral border surrounds the base. The base and the peripheral border have a first side covered with a releasable adhesive adapted to releasably engage a patient's skin when the base and peripheral border are placed over the surgical site prior to an incision.

An expandable housing is mounted to a second side of the border in surrounding relation to the base. A hollow interior is defined by a space between the base and the expandable housing.

An air purifier has an outlet connected in fluid communication with the hollow interior and an air pump is in fluid communication with an inlet of the air purifier.

The expandable housing expands to a predetermined shape that at least partially encloses the patient when purified air is introduced into the hollow interior. The members of the surgical team are external to the housing when said housing is fully expanded.

If the housing is made of a transparent material, the members of the surgical team can see inside the housing and no viewing portals are required. However, if the housing is made of a translucent or opaque material, at least one viewing portal formed of a clear material is required. The number, size, shape, and positioning of the viewing portal or portals is not critical to the invention and may be determined by the type of surgery to be performed, the number of members of the surgical team, and the like.

A plurality of hand portals are also formed in the sterile inflatable drape. Each hand portal of the plurality of hand portals has an interlock that substantially inhibits unpurified, ambient air from entering into the hollow interior when the hollow interior is expanded by purified air flow thereinto.

A sterile instrumentation chamber is formed in the sterile inflatable drape to facilitate introduction of surgical tools into the hollow interior. The sterile instrumentation chamber includes a passage having an interlock for substantially preventing ambient air from entering into the hollow interior when a tool is introduced into the hollow interior. A primary object of the invention is to decrease infection rates for all surgical procedures without incurring the expense of a conventional laminar flow operating room.

Another important object is to accomplish the foregoing object with a device that is inexpensive to manufacture, easy to use, and that does not require closure of an operating room. BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the invention, reference should be made to the following detailed description, taken in connection with the accompanying drawings, in which:

FIG. 1 is a perspective view of the novel drape in its deflated configuration;

FIG. 2 is a perspective view depicting placement of the novel device prior to its inflation with the inflatable part of the device removed to simplify the drawing;

FIG. 3 is a perspective view of the device when positioned as in Fig. 2, said depiction obscuring the part depicted in Fig. 2;

FIG. 4 is a schematic of the novel drape in its inflated configuration; FIG. 5 is a rendering of the inflatable drape after inflation; and FIG. 6 is a perspective view of an alternative embodiment of the inflatable surgical drape.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Novel drape 10 is depicted in Fig. 1 in its deflated configuration. It has a rectangular, boxlike shape in this particular embodiment but other shapes are within the scope of this invention.

Peripheral border 12 of drape 10 is covered with a suitable adhesive. As best understood in connection with Fig. 2, this adhesive releasably connects drape 1 0 to a body part of a patient. In the example of Fig. 2, drape 10 is adhered to the area that surrounds a patient's knee, in preparation for a surgical procedure known as a knee arthroplasty. Bed 1 1 supports the patient.

Referring again to Fig. 1 , a suitable releasable adhesive may also be applied to area 14 that is surrounded by peripheral border 12 to cover the patient's skin that surrounds an incision.

The adhesive used in areas 12 and 14 may be covered prior to use by peel and seal strip of the type commonly used on mailing envelopes.

Drape 10 is provided in expandable form, having an accordion-like form denoted by the reference numeral 16 in Fig. 1. Flexible, sterile intake hose 18 provides fluid communication between the interior of drape

10 and an air purifier, not depicted in Fig. 1. The structure of drape 10 allows it to expand as purified air is pumped into it. In this example, after area 14 is opened to provide access to the knee, the knee will be surrounded by such purified air as drape 10 expands. Skin near the incision will be covered by the part of area 14 that is adhered to the skin and is not uncovered by the surgeon's scalpel. Accordingly, the incision and the area contiguous thereto are exposed to purified air only and the areas surrounding those incision- contiguous areas are covered by the part of area 14 that is not opened.

A typical incision for knee arthroplasty is made along the line denoted 20 in Fig. 2. Fig. 2 depicts only adhesive-covered border area 12 and area 14 enclosed thereby to simplify the drawing to enabling simple depiction of incision location 20.

Fig. 3 depicts deflated drape 10 in perspective view when installed in protecting relation to a patient's knee. Such placement follows appropriate skin preparation.

Fig. 4 depicts drape 10 in its inflated configuration. Both the patient and the patient- supporting surface of bed 1 1 are now enclosed within the inflated structure. Intake hose 18 provides fluid communication between source 22 of purified air and interior 24 of inflated drape 10. The pressure of the purified air inflates the structure and maintains its inflated configuration for as long as is needed. At the conclusion of the surgical procedure, the power to air purifier 22 is turned off and structure 10 is folded so that border part 12 and section 14 may be removed from the skin around the incision. Drape 10 is then discarded.

Members of the surgical team are stationed outside of the enclosure created by inflation of drape 10. They view the interior space through clear vision portals, collectively denoted

26, which are preferably formed of a thin, clear, flexible plastic provided at a convenient height. Any number of such portals 26 in any position and in any shape is within the scope of this invention. It may also be desirable to form drape 10 of a transparent material to obviate the need for viewing portals 26. The hands and arms of the members of the surgical team gain access into hollow interior

24 through hand and arm portals, collectively denoted 28. Portals 28 may be provided in conventional form, with each portal having a sealed interlock to substantially prevent external air from entering into hollow interior 24 when hands and arms are inserted through said portals. The interlocks could simply be provided in the form of a door formed of two confronting plastic strips. They could also include sleeves with rubber bands that close under their inherent bias when an arm or hand is removed from a sleeve.

One or more similar interlocks, not depicted, are also provided at box-like instrument exchange zone 30. Box 30 enables members of the surgical team to introduce various sterilized surgical tools, also not depicted, into hollow interior 24 as needed and to retrieve them or move them out of the way as they are no longer needed. Instrument exchange zone 30 is depicted as being in open communication with interior 24 at the foot of bed 1 1 but other positions of said zone 30 are within the scope of this invention.

Portal 32 is a drain and is positioned at a lowermost point of the inflated drape. It is connected to a vacuum source through a valve to collect liquid fluids that may flow to the bottom floor of drape 10. Collected blood is delivered to a device such as a Cell Saver® blood salvage device, so that said blood may be transfused to the patient during or after conclusion of the surgery.

Fig. 5 is a perspective view much like that of Fig. 4 but depicting drape 10 having rounded surfaces to provide a more life-like view thereof. The reference numerals in Fig. 5 identify the parts already disclosed in connection with Fig. 4.

Fig. 6 discloses a simpler embodiment, perhaps more suitable for field use, that encloses less than the entire body of a patient. This embodiment is inflated by air purifier 22 by means of hose 18 as in the first embodiment but no viewing ports 26 are needed because the drape material is transparent. Hand and arm portals 28 equipped with suitable interlocks are provided in this embodiment, but instrument exchange zone 30 is not. The feet as well as the head and shoulders of the patient may be external to hollow interior 24 in this embodiment. Some leakage will occur around such body parts but the flow of purified air into hollow interior 24 ensures that external air cannot enter into interior 24 through such unsealed points.

In a smaller version of the novel apparatus, having increased utility in the field, drape 10 may include a stretcher-like surface pad for the patient to rest upon, immobilized if necessary, thereby providing additional protection from the environment. The resting pad is formed integrally with the drape, with a preselected edge of the pad formed integrally with the drape and the remaining three (3) edges being releasably attachable by well- known fastening means such as hook and loop fasteners, clips, ties, and the like.

Drape 10 may be manufactured by modifying the IOBAN® drape made by 3M Corporation. It is applied over a surgical site after skin cleansing has been performed with any acceptable surgical skin preparation such as Betadyne, isopropyl rubbing alcohol, chlorhexadine, and the like. The areas of the patient's body that will not be operated upon are covered with conventional cloth or sterile paper drapes.

Drape 10 expands and contours itself to the general shape of the patient and operating surface. It confines the surgical team to a relatively small zone of movement during the surgery. Individual drapes to accommodate different surgical procedures are preferred.

For example, the spatial requirements for a total knee replacement procedure may be slightly different from the spatial requirements of a total hip replacement procedure.

Embedded plastic tabs of the type used to open mailing envelopes could be incorporated into drape 10 to provide a quick release function. Such tabs would be positioned in the base of the drape that circumscribes the inflatable part thereof so that pulling the tabs would separate the inflatable part of the drape from its non-inflatable base. In the alternative, the base and the inflatable part could be separated from one another by use of a scalpel.

Figs. 4 and 5 depict an embodiment including regions where drape material has been perforated so that a user can form an emergency access opening in drape 10 along such perforations so that no tool would be needed to gain access into the area enclosed by the drape if needed on an emergency basis. The dimensions of the drape will vary depending upon the surgical environment and type of surgery performed. In most applications, the drape would extend above the level of the operating table by about four feet (4'). The vertical clearance could be lower in the field, perhaps being positioned only one or two feet above the patient.

The shape of the drape also varies depending upon the surgical environment and type of surgery performed. As depicted in Figs. 4 and 5, a cubical shape is preferred for a conventional operating room. Round shapes, pyramidal shapes, and other geometrical shapes are within the scope of this invention.

As shown in Figure 6, the surface upon which the patient lies is distinct from, but releasably connected to, the adhesive/inflatable surface. The patient is in effect wrapped inside the drape, and the inflatable part covers more of the patient providing some protection from the environment.

The novel drape could also be releasably attached at its peripheral edges to helmets or other head gear worn by members of the surgical team. The means of attachment could include several embodiments. A VELCRO® hook and loop fastening member or a magnetic attachment would likely provide the easiest attachment. Each helmet would include a clear face shield. A suitable helmet is manufactured by Stryker Orthopaedics and sold under the name T4® personal protection system). In Fig. 5, the rectangles above and below surgeon viewing portals 26 could provide adhesive, hook and loop, magnetic, or the like, releasable attachment means to releasably interconnect the helmet and drape 10.

Purified air is introduced into the novel drape housing by a device that includes several embodiments. Air purification may be accomplished by multiple means such as air filtration, irradiation, and heating. These purification systems may be portable and may include self-contained power systems such as a battery or gas powered compressor. It may be beneficial to introduce heated air into the enclosure to maintain core body temperature for the patient in cold operating room environments.

Drape 10 may be equipped with incandescent, fluorescent or LED lighting where conventional power is available. Chemiluminescent lighting, such as a light stick, will have utility in the field.

The drape could also be manufactured with clear regions in the ceiling of the drape with handles to grasp overhead lights, or members of the surgical team could wear headlamps. Drape 10 can be used anywhere a power source to operate an air purifier is available. A self-contained power source could be integrated into the purifier. This would make it ideal for use in developing nations where air quality in an operating room may be poor. A self- contained power source would also have utility in portable military or first responder medical units, or in any open field where conventional power sources are not available.

Drape 10 has utility in connection with any open surgical procedures where direct visualization of the skin surrounding an incision is not required. Cosmetic or 'plastic' surgical procedures requiring reorientation of portions of skin in order to change the surround skin's appearance would be one of those procedures.

This device is particularly beneficial in connection with orthopedic joint replacement and orthopedic trauma surgery.

The novel device provides a less expensive and more effective alternative to laminar flow technology.

It will be seen that the advantages set forth above, and those made apparent from the foregoing disclosure, are efficiently attained and since certain changes may be made in the above construction without departing from the scope of the invention, it is intended that all matters contained in the foregoing description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.

Claims

What is claimed is:

1 . A sterile inflatable drape, comprising: a base having a size and shape adapted to cover a surgical site, said surgical site including an incision and an area contiguous to said incision ; a peripheral border that surrounds said base; said base and said peripheral border having a first side covered with a releasable adhesive adapted to releasably engage a patient's skin when said base and peripheral border are placed over said surgical site prior to an incision; an expandable housing mounted to a second side of said border in surrounding relation to said base; a hollow interior defined by a space between said base and said expandable housing; an air purifier having an outlet connected in fluid communication with said hollow interior; an air pump in fluid communication with an inlet of said air purifier; said expandable housing expanding to a predetermined shape that at least partially encloses a patient when purified air is introduced into said hollow space.

2. The sterile inflatable drape of claim 1 , further comprising: a plurality of hand portals formed in said inflatable drape; each hand portal of said plurality of hand portals having an interlock that substantially inhibits unpurified air from entering into said hollow interior when said hollow interior is expanded by purified air flow thereinto.

3. The sterile inflatable drape of claim 1 , further comprising: said sterile inflatable drape being formed of a transparent material.

4. The sterile inflatable drape of claim 1 , further comprising: said sterile inflatable drape being formed of an opaque material; at least one transparent viewing portal formed in said sterile inflatable drape.

5. The sterile inflatable drape of claim 1 , further comprising: a sterile instrumentation passage formed in said sterile inflatable drape device to provide a chamber for introducing surgical tools into said hollow interior; said sterile instrumentation passage including an interlock for substantially preventing ambient air from entering said hollow interior.