Drape for equipment having cylindrical or other non-planar contours

A drape (600) suitable for covering non-planar surfaces of equipment (1201) is provided. The drape (600) facilitates quick and efficient deployment while ensuring that a sterile field established by a drape portion (601) is not compromised. The drape (600) can include a drape wrapping layer (209) wrapped about a drape portion (601) that is formed initially with two abutting elongated accordion fold stacks (604,605). Non-sterile personnel (801) can handle the drape wrapping layer (209) to position the drape (600) along surfaces of the equipment (1201) without touching the sterile drape portion (601). Sterile personnel can then expand the abutting elongated accordion fold stacks (604,605) to drape the surfaces of the equipment (1201).

BACKGROUND

Technical Field

This invention relates generally to drapes, and more particularly to drapes for equipment having non-planar contours, such as Magnetic Resonance Imaging (MRI) and other medical equipment.

Background Art

In clinical environments, such as hospitals, medical offices, and ambulatory surgical centers, a wide range of equipment is used to perform diagnostics and procedures. This equipment can include devices like imaging equipment, ultrasound probes, microscopes, and radiographic equipment. This equipment is generally large.

At the same time, healthcare facilities are increasingly concerned about the occurrence of secondary complications occurring during medical and surgical procedures. For example, during a medical procedure on an otherwise healthy patient, there is the possibility that a secondary infection or other complication can result. As a result, more attention is being turned to establishment and maintenance of sterile fields about patients and procedure sites during medical procedures. For example, some healthcare facilities request medical professionals to check and double check certain conditions, such as whether a proper sterile field has been established or whether a proper sterile field can be maintained.

When a procedure involves a large piece of equipment, establishment and maintenance of sterile fields can become a complex problem. To begin, adequately cleaning and sterilizing the various surfaces and contours of the equipment between usages is difficult. This makes it challenging for medical professionals to ensure that patients are not inadvertently exposed to surgical fluids or other contaminants disposed on the equipment. Moreover, even where a sterile field is established, it is difficult to ensure that the sterile field is maintained. A single non-sterile person coming into contact with a previously sterilized surface can compromise a sterile field.

There is thus a need for an apparatus and method for easily establishing and maintaining a sterile field on equipment, even where the equipment has non-planar surfaces.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

Embodiments of the present invention provide an equipment drape, suitable for use with medical or other equipment having non-planar surfaces, that is simpler to unfold and quicker to apply to non-standard surfaces than are prior art drapes. Moreover, embodiments of the present invention facilitate this simpler, quicker deployment without the risk of compromising sterile fields. The ease and efficiency with which embodiments of the present invention can be used is due in part to the way that embodiments of the present invention are folded. The ease and efficiency is also due to the constituent parts of each apparatus, some of which are handled by non-sterile personnel and some of which are handled by sterile personnel. Additionally, while some prior art drapes took six or more steps or mechanical manipulations, each of which had to be performed only by sterile personnel who risk contamination with every step, embodiments of the present invention can be put into use with far fewer steps, and with sterile personnel performing even fewer steps, thereby reducing the risk of compromising their sterile status.

While medical applications will be used herein for illustrative purposes and simplicity of discussion, it will be clear to those of ordinary skill in the art having the benefit of this disclosure that applications for embodiments of the present invention are not so limited. Embodiments of the present invention can be used in any application where non-planar surfaces need to be protectively covered on a relatively large piece of equipment.

FIG. 1illustrates a piece of medical equipment100having non-linear surfaces101. The explanatory piece of medical equipment100is a MRI machine, although embodiments of the invention are not limited either to MRI machines or medical machines, as noted in the preceding paragraph.

The MRI machine has a cylindrical patient port102. This particular MRI machine is suspended from the ceiling in a medical facility. The MRI machine is moveable along two beams and can be transitioned from a non-sterile environment, such as a storage room, into a sterile environment, such as an operating machine. Accordingly, medical professionals are capable of imaging a patient undergoing surgery or other procedures without moving the patient to another room. If, for example, a patient is sedated and undergoing surgery, the medical professional is able to cause the MRI machine to enter the operating room so that the patient can be imaged.

As can be appreciated, it is imperative that sterile fields about the patient be maintained. For instance, if a patient has a surgical opening, contact with a non-sterile surface could potentially cause the patient to suffer from a secondary complication. Consequently, the cylindrical patient port102must be completely sterile. This can be accomplished in one of two ways. The first is to fully sterilize the MRI machine between each use. As noted above, cleaning can be a difficult process. The illustrative MRI machine ofFIG. 1is large, weighing approximately 17 tons. Ensuring that the entire cylindrical patient port102is completely sterile is difficult and incredibly time consuming.

The second method is to “drape” the cylindrical patient port102. Draping involves covering the non-linear surfaces101to which the patient has access with a sterile covering. Prior art attempts include adhesively coupling flat, rectangular sheets in layers about the entire non-linear surface. This method has problems as well. First, sterile personnel must perform the draping procedure. If non-sterile personnel drape the cylindrical patient port102, the sterility of the drape is compromised. However, since the MRI machine is not sterilized between procedures, non-patient surface103may not be sterile. If sterile personnel come in contact with such a non-patient surface103, their sterile condition is compromised. Accordingly, they must re-perform the sterilization process, which is again time consuming.

Embodiments of the present invention solve this process by providing a drape that is wrapped within a drape wrapping layer. The drape wrapping layer, which can be handled by non-sterile personnel, can be unfolded to reveal a sterile drape portion. In one embodiment, the sterile drape portion is configured with accordion folds to form two abutting stacks. Sterile personnel can then expand the accordion folded stacks to drape non-planar surfaces of medical equipment. In one or more embodiments, coupling devices can be attached to the sterile drape portion to make attachment and detachment of the sterile drape portion to the medical equipment even simpler.

Turning toFIG. 2, illustrated therein is a folded drape200. The folded drape200includes a book fold201disposed between two folded drape halves202,203. The two folded drape halves202,203are arranged such that the major faces (301,302ofFIG. 3below) of each folded drape half202,203are disposed adjacent with each other in a shared relationship. As a first step in a draping operation, the book fold201can be unfolded208, which results in the semi-folded drape (300) shown inFIG. 3.

The exterior surfaces of the folded drape200that are visible inFIG. 2are a drape wrapping layer209. In one embodiment, the drape wrapping layer209is a Central Sterile Reprocessing (CSR) wrap that is used widely by medical professionals in hospitals, ambulatory surgical centers, and the like during medical procedures. While a CSR wrap is one example of a wrap that can be used, it will be clear to those of ordinary skill in the art that other wraps, such as plastic, cotton, linen, paper, or combinations thereof, can be substituted without departing from the spirit and scope of the invention. For example, the drape wrapping layer209can be manufactured from other materials, such as spunbond-meltblown-spunbond material. Other materials can be used for the drape wrapping layer209, including, for example, various woven, non-woven, hydroentangled materials, and/or combinations thereof, absorbent Airlaid, spunlace, blends of polyester, polypropylene, polyethylene, urethane, and/or combinations thereof, using various methods, including a spunbond metblown spundbond (SMS) method, a spunbond metblown metblown spundbond method (SMMS), and a spunbond metblown metblown spundbond method (SMMMS). Suppliers of such materials include Cardinal Health in Dublin, Ohio, Kimberly Clark in Neena, Wis., Molnycke Health Care in Newtown, Pa., and Precept Medical Products, Inc., in Arden, N.C. One or more antimicrobial layers can be added to the drape wrapping layer209further enhance antimicrobial protection. Additionally, the drape wrapping layer209can optionally include and water resistant lining that prevents the passage of fluids through the material.

In one embodiment, the drape wrapping layer209is configured to be opaque. For example, in one embodiment, the drape wrapping layer209comprises a blue CSR wrap. As will be shown below with reference toFIG. 7, in one embodiment a drape portion is non-opaque, and can be translucent, transparent, or pellucid. In accordance with one or more methods described herein, non-sterile personnel can handle the drape wrapping layer209, while sterile personnel handle the drape portion. By making the drape wrapping layer209opaque, and the drape portion non-opaque, the overall assembly provides a simple, clear mnemonic device to personnel regarding which portion is to be handled by sterile personnel and which is to be handled by non-sterile personnel.

The explanatory folded drape200ofFIG. 2includes one or more indicators204,206disposed on an outer surface205of the folded drape200. In the illustrative embodiment ofFIG. 2, two indicators204,206are included, with a first indicator204being disposed on an upper outer surface205, and a second indicator206being disposed on a lower outer surface207. The indicators of this explanatory embodiment provide indications of which portion of the folded drape200are configured to be the bottom portion when the folded drape200is ultimately unfolded. For instance, the indicators204,206ofFIG. 2read “this side center down” and include an arrow that indicates how to unfold the folded drape200. Other indicators can be used, and will be readily obvious to those of ordinary skill in the art having the benefit of this disclosure. Using the indicators204,206of the explanatory embodiment ofFIG. 2, medical personnel is instructed regarding which outer surfaces205,207of the folded drape200should be placed adjacent to the non-planar surfaces of the medical equipment.

Turning toFIG. 3, illustrated therein is a semi-folded drape300. The semi-folded drape300results from unfolding the book fold201between the two folded drape halves202,203. Unfolding the book fold201also reveals the major faces301,302that were shared in the folded drape (200) ofFIG. 2.

As shown inFIG. 3, two additional indicators304,306are revealed when the book fold201is unfolded. The indicators304,306are disposed along the drape wrapping layer209. The indicators304,306ofFIG. 3, which were hidden inFIG. 2, provide instruction to personnel regarding how to unfold the semi-folded drape300to obtain the partially folded drape (400) shown inFIG. 4. In this illustrative embodiment, the indicators304,306are arrows instructing personnel to open book folds303,305. Symbols are useful on indicators304,306because they are universal and are not defined by a particular language. However, it will be clear to those of ordinary skill in the art having the benefit of this disclosure that text or other indicia can be placed on indicators304,306as well.

The semi-folded drape300includes two book folds303,305. When the two book folds303,305are present, a first semi-folded drape end307passes over a base member309, with a first semi-folded drape portion310sharing a major face with the base member309. Similarly, a second semi-folded drape end308passes over the base member309, with a second semi-folded drape portion311sharing a major face with the base member309. As shown inFIG. 3, in one embodiment the first semi-folded drape end307abuts the second semi-folded drape end308along a central portion314of the semi-folded drape300.

When personnel unfolds312,313the book folds303,305in accordance with the arrows present on the indicators304,306, the result is the partially folded drape400shown inFIG. 4. Turning now toFIG. 4, the partially folded drape400includes two additional book folds403,405.

The book folds403,405ofFIG. 4combine with the book folds (303,305) ofFIG. 3to form a “double book fold.” The double book fold is useful in many applications. For example, where used with a MRI machine, the cylindrical patient port (102) can have a length of nearly six feet. One of the difficulties of draping such a cylindrical patient port (102) is that it is difficult for someone to pass something from one end to the other while preserving the sterile field. The double book fold allows a long component to be manageably placed in a pouch or shipping container, yet yields a long device sufficient to span the length of a cylindrical patient port.

When the two book folds403,405are present, a first partially folded drape end407passes over a base member409, with a first partially folded drape portion410sharing a major face with the base member309, which has become elongated compared with the semi-folded drape (300) ofFIG. 3due to the unfolding (312,313) of book folds (303,305). Similarly, a second partially folded drape end408passes over the base member309, with a second partially folded drape portion411sharing a major face with the base member309. In one embodiment, the first partially folded drape end407abuts the second partially folded drape end408along a central portion314of the partially folded drape400. When personnel unfolds412,413the book folds403,405, the result is the envelope folded drape500shown inFIG. 5.

Turning toFIG. 5, a first envelope portion510and a second envelope portion511are wrapped about a drape portion with two book folds503,405. The drape portion is not visible inFIG. 5, but will be visible when the first envelope portion510and the second envelope portion511are unfolded512,513about the two book folds503,505. When this is done, the drape600ofFIG. 6results.

Turning now toFIG. 6, illustrated therein is a drape600configured to cover non-planar surfaces of equipment in accordance with one or more embodiments of the invention. The drape wrapping layer209, having been unfolded as shown inFIGS. 2-4, is disposed beneath a drape portion601. The drape wrapping layer209defines a wrapping layer length602and a wrapping layer width603.

The drape portion601is disposed centrally along the drape wrapping layer209. In this embodiment, the drape portion601is configured in two abutting elongated accordion fold stacks604,605. A bottom section608spans and links the two abutting elongated accordion fold stacks604,605. The two abutting elongated accordion fold stacks604,605each abut along a center-line609. The two abutting elongated accordion fold stacks604,605of the drape portion601define a stack width606and a stack length607. In the illustrative embodiment ofFIG. 6, the stack width606is less than the wrapping layer width603. Similarly, the stack length607is less than the wrapping layer length602.

As noted above, in one embodiment, the drape portion601is configured to be translucent, transparent, or pellucid, while the drape wrapping layer209is configured to be opaque. In one embodiment, the drape portion601is manufactured from a clear 0.05 mm polyethylene sheet. However it will be clear to those of ordinary skill in the art having the benefit of this disclosure that other materials can be used as well. Such materials include blends of polyester, urethane, or other flexible materials. In one or more embodiments, the drape portion601is configured to be sterile.

In practice, non-sterile personnel can perform the unfolding operations described inFIGS. 2-4. The non-sterile personnel are able to position, unfold, and move the drape by handling only the drape wrapping layer209. Thus, the sterile drape portion601remains sterile. Once the non-sterile personnel position the drape600correctly, sterile personnel can then manipulate the drape portion601to expand the two abutting elongated accordion fold stacks604,605as shown inFIG. 7. Note that the bottom section608of the drape portion601can be more readily seen inFIG. 7. This sterile/non-sterile deployment process is shown in detail inFIGS. 8-10.

Beginning atFIG. 8, non-sterile personnel801dispose the folded drape (200) ofFIG. 2along a surface802of equipment. In the illustrative embodiment ofFIG. 8, the surface802is cylindrical, as would be the case if the equipment were a MRI machine such as the one shown inFIG. 1. In accordance with one or more indicators disposed on the folded drape (200), the non-sterile personnel801unfold the folded drape (200) to form the semi-folded drape300shown inFIG. 8. The non-sterile personnel801continues to unfold the semi-folded drape as described above with reference toFIGS. 3 and 4to reveal the sterile drape portion601disposed atop the drape wrapping layer209as shown inFIG. 9. Handling only the drape wrapping layer209, which covers a larger area than the two abutting elongated accordion fold stacks604,605of the drape portion601, the non-sterile personnel (801) is able to position the drape600as necessary along the surface802of the equipment without compromising the sterile condition of the drape portion601.

Turning toFIG. 10, once these steps are completed, sterile personnel1001,1002are then able to extend the two abutting elongated accordion fold stacks604,605along the surfaces802of the equipment. This process results in simple and efficient deployment of the drape portion601without compromising the sterile field defined by the drape portion601.

In one or more embodiments, to make attachment of the drape portion601to equipment easier, one or more coupling devices can be disposed both on the drape portion601and the equipment. Turning now toFIG. 11, one example of such coupling devices1101,1102,1103,1104is shown.

In the illustrative embodiment ofFIG. 11, the coupling devices1101,1102,1103,1104are configured for selective attachment to the equipment. The coupling devices1101,1102,1103,1104are disposed at distal ends of the drape portion601. One such distal end1105is shown in FIG.11. In one embodiment, the coupling devices1101,1102,1103,1104comprise portions of hook and loop fasteners. A complementary portion of the hook and loop fastener can then be disposed on the equipment. For example, coupling devices1101,1102,1103,1104can be the “loop” portion of a hook and loop fastener, while the complementary portions disposed on the equipment are the “hook” portions. The opposite configuration can be used as well. While hook and loop fasteners are one type of coupling or attachment device suitable for use with the drape portion601, it will be clear to those of ordinary skill in the art having the benefit of this disclosure that other coupling devices can be used as well. Examples include snaps, hooks, magnets, adhesives, and so forth. Thus, in one embodiment of a deployment process, after the sterile personnel (1001,1002) expand the two abutting elongated accordion fold stacks (604,605) as shown inFIG. 10, they may attach the drape portion601to the equipment1201as shown inFIG. 12.

While the drape portion601ofFIG. 12drapes the entirety of the cylindrical patient port, some applications will require only a portion of a non-planar surface to be draped. Recall from above that the equipment100ofFIG. 1was moveable along rails mounted to the ceiling into an operating room to scan a patient undergoing surgery. In such environments, the patient is likely laying on a sterile work surface. Where this is the case, it may be unnecessary to drape the bottom portion of the cylindrical patient port because the sterile field is provided by the work surface. Moreover, draping the bottom half of the cylindrical patient port may cause the work surface to snag on the drape portion601when the equipment1201passes about the work surface.

To accommodate such environments, an alternate method of attaching a drape portion601to equipment is shown inFIG. 13.FIG. 13illustrates a next step that can occur after the step shown inFIG. 10, where sterile personnel1001(1002) extend the two abutting elongated accordion fold stacks604,605along the surfaces802of the equipment. As shown inFIG. 13, two coupling devices1101,1103are attached to an outer surface1301of the equipment. Once this is complete, the bottom section608can be lifted by the sterile personnel1001for attachment to only the top surfaces of the equipment. This process results in simple and efficient deployment of the drape portion601along only a portion of the surface802.

Turning toFIG. 14, illustrated therein is the alternate embodiment of the drape portion601after having been deployed and attached to the medical equipment100ofFIG. 1. InFIG. 14, the drape portion601is configured to only cover the upper portion of the cylindrical patient port102. As noted, such an embodiment would be suitable for use in an operating room where a patient is lying on a sterile work surface. The sterile work surface could be passed through the cylindrical patient port102. To ensure the sterile work surface is not compromised, the upper surface of the cylindrical patient port102is covered by the drape portion601. Since the sterile work surface covers the lower portion of the cylindrical patient port102, it may not be necessary to drape that portion as well.

FIG. 14is the result of a deployment process shown inFIG. 13in which non-sterile personnel (801) disposed a folded drape (200) along a surface of the equipment100. In this illustration, the surface is the cylindrical patient port102of the MRI machine. The non-sterile personnel (801) then unfolded the folded drape (200) to reveal the sterile drape portion601, which was initially configured as two abutting elongated accordion fold stacks (604,605) linked by a bottom section608and disposed centrally along a drape wrapping layer209(which is still present inFIG. 14, but would be removed prior to a patient being passed through the cylindrical patient port102). Sterile personnel then extended the two abutting elongated accordion fold stacks (604,605) of the drape portion601along surfaces of the equipment100, and attached the sterile drape portion to the equipment100using coupling devices1101,1102,1103,1104to define a sterile area along an upper portion of the cylindrical patient port102.

Turning toFIG. 15, illustrated therein is a flow chart showing the method described pictorially above for deploying a drape configured in accordance with embodiments of the invention. At step1501, a folded drape is disposed along a surface of equipment. In one embodiment, non-sterile personnel perform step1501.

At step1502, the folded drape is unfolded to reveal a sterile drape portion comprising a bottom section linking two abutting elongated accordion fold stacks. Where indicators on the folded drape are provided, step1502can include reading one or more indicators prior to the disposing to determine how to dispose the folded drape along the surface of the equipment.

At step1503, the two abutting elongated accordion fold stacks are extended along surfaces of the equipment. In one embodiment, sterile personnel perform step1503. At step1504, the sterile drape portion is attached to the equipment. In one embodiment, step1504is accomplished by using attachment devices that are disposed on distal ends of the sterile drape portion. For example, step1504can include fastening a first portion of a hook and loop fastener disposed on the sterile drape portion to another portion of the hook and loop fastener disposed on the equipment.

Turning now toFIG. 16, illustrated therein is one explanatory method of making a drape configured in accordance with one or more embodiments of the invention. At step1601, a sterile drape portion is obtained. This can be accomplished by manufacturing the drape and sterilizing it, or by sourcing a drape layer and sterilizing it. At optional step1602, one or more coupling devices can be attached to the sterile drape portion. In one embodiment, the coupling devices are attached to the drape portion at distal ends. Such an embodiment is useful for draping operations used for MRI machines with cylindrical patient openings. At step1603, the sterile drape is configured with accordion folds to form two abutting elongated accordion fold stacks linked by a bottom section.

At step1604, a drape wrapping layer is obtained. In one embodiment, the drape wrapping layer is a CSR wrap. At step1605, the sterile drape portion is wrapped with the drape wrapping layer to form a wrapped drape. This step1605can include by creating an envelope fold with the drape wrapping layer about the drape portion. At step1606, one or more book folds are created to form a folded drape. One or more indicators can be attached to the drape wrapping layer in either step1605or step1606. For example, the indicators can provide instruction in how to unfold the drape wrapping layer. Alternatively, the indicators can indicate which portion of a folded drape wrapping layer is configured as a bottom portion of the folded drape wrapping layer when unfolded.