Patent Description:
Typically, the height of the stand can be adjustable. The tray of the stand may be removable for easier cleaning and sterilization. The Mayo stand may be fitted with wheels or a rolling base to aid in maneuverability of the stand to the desired location within the operating room or medical office. Mayo stands come in a wide variety of sizes and configurations to accommodate specific medical practices.

In addition to requiring close and quick access to medical instruments, there are many other items and procedures associated with different medical practices that require quick and easy solutions. Some surgeries and other procedures are performed only after extensive planning and use large, sometimes cumbersome, equipment to help position a patient or the patient's extremities for the procedure. A standard operating surface can include a medical table, a hospital bed, or a type of reclining chair. These are usually found in hospitals, but less equipment is usually available for in-office procedures that may also benefit from more adjustable or robust equipment.

<CIT> discloses a sterile cover for a tray of a Mayo stand. <CIT> discloses a support stand with a cushioned top surface for an arm of a patient that can be attached to a patient table. <CIT> discloses a cover for a Mayo stand with a tray, the cover comprises a padded section position on the tray upper surface.

In some cases, a doctor may find that repositioning a portion or extremity of the patient's body during surgery would be beneficial for a certain step or certain number of steps. It is difficult to obtain, transfer or move either the equipment or the patient after the surgery or other medical procedure has been started. Sometimes, doctors look for ad-hoc ways to overcome the limitations of the standard equipment found in the operating room or office. However, there are limited to no equipment or devices available having surfaces conducive to acting as operating or procedural surfaces for soft-tissue contact (e.g., metal or very hard plastics are unsuitable for direct contact with skin, especially with any pressure from the weight of the extremity).

Thus, there is a persistent and on-going need for improved devices and methods for patient positioning for some surgeries and procedures whether performed in a hospital or in the doctor's office.

Embodiments disclosed herein relate to a specialized type of cushion device that allows for a standard medical instrument stand (e.g., Mayo stand) to be converted to a cushioned operating or positioning surface for a patient.

The invention is defined by independent claims <NUM> and <NUM>, with further embodiments disclosed by the dependent claims. The cushion device is configured for placement on a medical instrument stand. The cushion device includes an upper portion having a front side, a rear side, first and second longitudinal sides, an upper surface, and a bottom surface. The cushion device also includes a front portion connected to the front side of the upper portion and extending downwards therefrom. The first and second side portions each connect respectively to the first and second longitudinal sides of the upper portion and extending downward therefrom. A hollow receptacle is defined by the front portion, the first and second side portions, and by the bottom surface of the upper portion. The hollow receptacle is configured in size and shape to receive a medical instrument tray. Embodiments herein also relate to a method to cushion a medical instrument tray.

A more particular description will be rendered by the embodiments illustrated in the appended drawings. It is appreciated that these drawings depict only exemplary embodiments of the disclosure and are therefore not to be considered limiting. In the accompanying drawings:.

In some instances, medical instrument stands (e.g., Mayo stands) may be used to at least partially support a patient's limb during a procedure. For example, a limb may be moved so as to extend off of the operating table, and the medical instrument stand may be positioned next to the operating table in order to support the limb. This allows for customizable use of the medical instrument stand and gives the medical practitioner flexibility in organizing and positioning the patient during the procedure.

However, use of a medical instrument stand in this manner is associated with several limitations. The hard surface of the tray does not provide good cushioning of the patient's limb. Further, portions of the patient's limb may be impinged by portions of the tray as the limb is laid across the tray. This can create pressure points leading to sores or even serious tissue damage, particularly given the fact that some procedures may last hours, during which time the patient is unconscious and unable to move or respond to pain indicators.

The present disclosure relates to cushion devices configured to adapt a medical instrument stand (e.g., Mayo stand) and allow the medical instrument stand to be effectively utilized for supporting a patient's limb or otherwise interfacing with the patient. The cushion devices described herein allow for these beneficial uses while avoiding the limitations that accompany such uses with a non-adapted Mayo stand.

<FIG> illustrates a conventional medical instrument stand <NUM> (an example of which is often referred to in the art as a "Mayo stand"). The medical instrument stand <NUM> includes an instrument tray <NUM> supported by a vertical member <NUM> (or sometimes multiple posts or other vertical members) connected to a base <NUM>. The instrument tray <NUM> may be removable or may be a component integral to the stand <NUM>. The vertical member <NUM> is often adjustable so that the height of the tray <NUM> above the floor can be adjusted. Often, the base <NUM> includes wheels to provide easy movement of the stand <NUM>, though some models may omit wheels and be configured to be simply slid across the floor to a desired position.

In use, the instrument stand <NUM> is usually positioned over or adjacent to a surgical site. The tray <NUM> then provides a place for instruments and/or supplies used during an operating room or in-office procedure. The tray <NUM> is usually removeable to allow for easy cleaning and maintenance. Such stands <NUM> are ubiquitous throughout medical facilities because of the many benefits provided, including minimizing wasted space in the operating room, mobility, customizable organization and use, durability, and ease of cleaning.

On at least some occasions, the stand <NUM> may also be used to prop a patient's limb during a procedure. For example, if a patient's arm needs to be extended away from the body and off the operating table during a procedure, the instrument stand <NUM> may be positioned next to the table to support or help support the arm. In other situations, the patient's leg may be extended off the operating table and supported at least in part by the stand <NUM>.

Easy positioning of the stand <NUM> beneficially allows these types of custom uses of the stand <NUM> during a procedure. However, propping a patient's limb as "dead weight" upon the tray <NUM>, which is typically formed of rigid metal, is associated with limitations. For example, the hard surface of the tray <NUM> does not provide good cushioning of the patient's limb. Further, the rim portion <NUM> of the tray <NUM> necessarily sticks up and can impinge against portions of the patient's limb laid across it. This can create pressure points leading to sores or even serious tissue damage, particularly given the fact that some procedures may last hours, during which time the patient is unconscious and unable to move or respond to pain indicators.

<FIG> illustrates the instrument stand <NUM> of <FIG> with a cushion device <NUM> positioned thereon. As shown, the cushion device <NUM> is configured to be selectively placed upon the tray <NUM> of the stand <NUM> of <FIG> and/or upon a portion of the frame of the stand <NUM> underlying the tray <NUM> (e.g., if the tray is removed before placement of the cushion device). This portion of the frame of the medical instrument stand associated with the tray and/or underlying the tray (e.g., the portion that the tray connects to) may be referred to herein as the "upper frame. " Most examples will be described herein in the context of positioning the cushion device <NUM> upon the tray <NUM>, but it will be understood that the same description applies to applications where the cushion device <NUM> is placed directly upon the frame of the stand <NUM> associated with the tray. The cushion device <NUM> is beneficially formed of a relatively soft, cushioning material that provides greater comfort, safety, and support to a limb positioned thereon.

In embodiments where the cushion device <NUM> is placed on the upper frame of stand <NUM> with the tray <NUM> removed, the cushion device <NUM> can advantageously have sufficient firmness or stiffness to span between the upper frame and support a limb and/or instruments without collapsing, such as by selection of cushion material of sufficient firmness or stiffness and/or providing an external or internal rigid or semi-rigid frame (not shown) e.g. of plastic, metal, and/or wood.

In some embodiments, the cushion device <NUM> may be formed from a polymer foam material, such as an open or closed cell foam, a "memory foam" (e.g., low-resilience polyurethane foam and/or other viscoelastic foams), rubber materials, gel padding, or combinations thereof. Some embodiments may also include a water-resistant coating, such as a flexible, water-resistant polymer (e.g., vinyl-based) that coats the foam material and allows for easy cleaning of the cushion device <NUM>. Some embodiments may include an external or internal frame (not shown).

Some embodiments may additionally or alternatively include a removeable "skin", such as a fabric or sterile sheet material, and may optionally include one or more zippers, hook and loop fasteners, buttons, snaps, and/or other means of donning and doffing the removeable skin. The removeable skin, for example, may be changed from patient to patient and/or from procedure to procedure for sanitary reasons and/or to reduce the amount of cleaning required. The skin may also be configured as a sterile bag. Additionally, or alternatively, the removeable skin may be configured as continuous roll of a sterile covering or sheet.

In some embodiments, the cushion device <NUM> is radiolucent. As used herein, the term "radiolucent" means that the device <NUM> allows substantial passage of imaging radiation (e.g. x-rays) and therefore allows for significant imaging contrast against other materials known to be more radiopaque in this context, such as bones, metal implants, and the like.

In certain applications of the cushion device <NUM>, the cushion device <NUM> may be configured to be removably secured to a stand <NUM> with its tray <NUM> removed. The cushion device <NUM> is able to fit onto the frame (not shown, but implied) that typically supports the tray <NUM> but can also support and stabilize the cushion device <NUM> even without the tray <NUM>. Thus, when used with a stand <NUM> having its tray <NUM> removed, the cushion device <NUM> can offer a radiolucent operating surface that is secured around the frame that usually supports the tray <NUM>. In other cases, such as where the tray <NUM> is radiolucent, the radiolucent cushion device <NUM> can be fitted onto the radiolucent tray <NUM> to provide a cushioned radiolucent operating and/or positioning surface. This is especially beneficial where the limbs or body must be positioned in a specific manner for effective imaging (e.g., for taking x-rays).

As shown in <FIG>, the cushion device <NUM> includes a front portion <NUM>, two side portions <NUM> that connect to the front portion <NUM> and extend longitudinally therefrom, and an upper portion <NUM> supported by the front portion <NUM> and side portions <NUM>. The cushion device <NUM> may also include a back portion <NUM> (better shown in <FIG>) which connects to the side portions <NUM> and is disposed opposite the front portion <NUM>.

The cushion device <NUM> may also include a rim <NUM> that extends along at least a portion of the upper portion <NUM>, preferably along the entire perimeter. The rim is preferably formed with a rounded "speedbump" cross-sectional shape that omits sharp corners. In addition to this shape, the soft (e.g., foam) construction of the components of the device help to provide good, cushioned support that limits or avoids pressure points on a limb positioned thereon. The rim <NUM> can also function to preserve the tray-like functionality of the stand <NUM>. That is, the rim <NUM> allows the cushion device <NUM> to be used for holding instruments and/or supplies (e.g., preventing them from falling) in the same fashion as the typical metal tray <NUM>. In other words, the rim <NUM> functions to prevent instruments from rolling off the edge of the cushion device <NUM>.

The bottom of the cushion device <NUM> is open so that the device can be readily positioned over the tray <NUM> of the stand <NUM> and lowered onto the tray <NUM>. That is, when the cushion device <NUM> is positioned, the tray <NUM> is received into a hollow receptable defined by at least the upper portion <NUM>, front portion <NUM>, and side portions <NUM>.

<FIG> illustrate additional views of the cushion device <NUM>. <FIG> illustrates a perspective view of the cushion device <NUM> of <FIG>. The view of <FIG> shows the front portion <NUM>, the two side portions <NUM> that connect to the front portion <NUM> and extend longitudinally therefrom, and the upper portion <NUM> supported by the front portion <NUM> and side portions <NUM>. As described above, the back portion <NUM> (see <FIG>) connects to the side portions <NUM> and is disposed opposite the front portion <NUM>, and the upper portion <NUM> further comprises the rim <NUM> that extends vertically upward from the outer perimeter collectively defined by the front portion <NUM>, the two side portions <NUM>, and the back portion <NUM>.

<FIG> illustrates a front view of the cushion device <NUM>. This view shows that the front portion <NUM> may have a rectangular shape with curved edges. A portion of the rim <NUM> is shown extending from a top line of the front portion <NUM>. It should be appreciated that the front portion <NUM> may comprise any suitable height conducive to aiding in positioning a patient via the medical instrument stand. Alternatively, or additionally, the rim <NUM> may extend from the front portion to any height. In some embodiments, the rim <NUM> may extend variably from the perimeter defined by the front portion <NUM>, side portions <NUM>, and back portion <NUM>. For example, the rim <NUM> adjacent to the front portion <NUM> may extend to a height that is greater than or less than a height to which the rim <NUM> extends from the side portions <NUM> or back portion <NUM>.

<FIG> shows a rear view of the device. As shown in <FIG>, the rear portion <NUM> may have a height that is smaller than a height of the front portion <NUM> and/or side portions <NUM>. For example, the rear portion <NUM> may extend down from the top surface <NUM> a distance that is less than the distance the front portion <NUM> extends down from the top surface <NUM>. In the illustrated embodiment, the rear portion <NUM> has a height that matches the thickness of the upper portion <NUM>.

The open rear side allows the cushion device <NUM> to be easily slid onto the tray <NUM>. For example, the cushion device <NUM> may be moved in a horizontal or somewhat horizontal fashion across the tray <NUM> and into position on top of the tray <NUM>. Alternative embodiments may include a larger rear portion <NUM>, such as one that extends lower and more closely aligns with the heights of the front portion <NUM> and side portions <NUM>. Such an embodiment would more completely encase the perimeter of the tray <NUM> when positioned over the tray <NUM>, but would likely have to be vertically lowered on top of the tray <NUM> rather than slid horizontally across the tray <NUM> and into position.

<FIG> also illustrates a contour portion <NUM> that connects to the upper portion <NUM> and extends downward therefrom. The contour portion <NUM> has a perimeter that sits within the perimeter of the upper portion <NUM> so that when the cushion device <NUM> is positioned on the stand <NUM>, the upper surface of the tray <NUM> (or associated portion of the frame of the stand) can contact the bottom surface of the contour portion <NUM> while the rim portion <NUM> of the tray <NUM> extends up around the contour portion <NUM> to contact the bottom surface of the upper portion <NUM>. This beneficially provides a more stable and conforming fit to standard tray geometry, and thereby serves to minimize or prevent sliding of the cushion device <NUM> upon the tray <NUM> or sagging of parts of the upper portion that otherwise would not initially contact the tray surface.

In some embodiments, the cushion device <NUM> may be configured to fit to the tray <NUM> of the stand <NUM> as discussed above. In some instances, the tray <NUM> may be removed from the stand <NUM>, exposing an upper frame (not shown) that supports the tray <NUM> during use. In some embodiments, the cushion device <NUM> may be configured to straddle and fit over the upper frame of the stand <NUM> that supports the removeable tray <NUM>. The uniquely designed cavity (i.e., contour portion <NUM>) of the cushion device <NUM> offers versatility to securely fit to either the tray <NUM> or the upper frame for the tray <NUM>.

The cushion device <NUM> may be configured with any suitable dimensions that allow a suitable fit to conventional medical instrument stand trays. Typically, the cushion device will have a length of about <NUM> to <NUM> inches, or about <NUM> to <NUM> inches, or about <NUM> to <NUM> inches, or about <NUM> to <NUM> inches, and will have a width that may be somewhat smaller than the length. For example, a width of about <NUM> to <NUM> inches, or about <NUM> to <NUM> inches, or about <NUM> to <NUM> inches. In some instances, the cushion device <NUM> may come in a small, regular, or large sizes (or any other number of varied sizes). In certain applications, a small sized cushion device <NUM> may fit trays <NUM> that measure <NUM>"x19" up to <NUM>"x19. A regular sized cushion device <NUM> may fit trays <NUM> that measure <NUM>"x21" up to <NUM>"x21. A large sized cushion device <NUM> may fit trays <NUM> that measure <NUM>"x25".

The front portion <NUM> and/or side portions <NUM> may have a height of about <NUM> to <NUM> inches, such as about <NUM> inches, with a thickness of about <NUM> to <NUM> inches, more preferably about <NUM> to <NUM> inches or about <NUM> inches. Similarly, the upper portion <NUM> may have a thickness of about <NUM> to <NUM> inches, more preferably about <NUM> to <NUM> inches or about <NUM> inches. These thicknesses have beneficially shown to provide good cushioning and support without being so thick as to take up unnecessary space or make the device unnecessarily large and cumbersome.

The rim <NUM> may have a height of about <NUM> inches to <NUM> inch, or more preferably about <NUM> inches to beneficially function as an instrument/supply border without being overly high so as to disrupt the ability to use the cushion device to support a patient's limb. Similarly, the contour portion <NUM> may have a height of about <NUM> inches to <NUM> inch, more preferably about <NUM> inches to beneficially better match the contour of the underlying tray <NUM> and thereby provide a better fit of the cushion device <NUM> over the tray <NUM>.

<FIG> illustrates a top view of the cushion device <NUM> and shows the upper portion <NUM> and the rim <NUM> as described herein. It is anticipated that the upper portion <NUM> may form any shape that allows the cushion device <NUM> to encompass the tray <NUM> of the stand <NUM>. In some embodiments, the upper portion <NUM> may comprise a shape that is different from the shape that is defined toward a bottom of the cushion device <NUM>.

As illustrated, the upper portion <NUM> may have a smooth, uniform surface comprised of a soft layer memory foam. The upper portion <NUM> is configured to provide a comfortable and safe surface for patient positioning that helps avoid skin or nerve damage. The upper portion <NUM> may also be utilized as an effective operating surface for hand and wrist procedures. The upper portion <NUM> may further comprise a protective layer or skin that is configured to protect the memory foam or softer top layer foam from contaminants. The protective layer may comprise a material that is antimicrobial and/or offers a surface that is easier to clean than the foam layer.

The upper portion <NUM> is preferably formed from a soft, viscoelastic "memory" foam material to conform to the patient's body and prevent soft tissue injuries. Such memory foam materials typically have a <NUM>% indentation load deflection (ILD) of about <NUM> to about <NUM> pounds, or more preferably about <NUM> to about <NUM> pounds. The foam material of the upper portion <NUM> may have a density of about <NUM> to about <NUM> pounds per cubic foot (PCF), preferably about <NUM> to about <NUM> PCF, or about <NUM> to about <NUM> PCF. <NUM> pound converts to <NUM>. <NUM> cubic foot converts to <NUM><NUM>. <NUM> pound per cubic foot converts to <NUM>,<NUM>/m<NUM>.

In some embodiments, one or more surfaces of the cushion device <NUM>, such as the upper portion <NUM>, may comprise ridges, indentations, patterning, depressions, or other features that assist in extremity positioning. Additionally, or alternatively, a removable layer configured to lay flush with the upper portion <NUM> may comprise the aforementioned features. For example, during hand and wrist procedures, a removable layer having a depression in the shape of a hand may be placed on top of the upper portion <NUM> to assist in stabilizing the hand during the procedure. In another example, the upper portion <NUM> may have a depression near the front portion <NUM> wherein the rim <NUM> also dips downward toward a middle region of the front portion <NUM> to facilitate a more comfortable positioning of an arm or a leg onto the cushion device <NUM>. These features may be referred to as contour features.

<FIG> illustrates a bottom view of the cushion device <NUM> showing the front portion <NUM>, two opposing side portions <NUM>, and the back portion <NUM> which collectively define a rectangular shape to the cushion device <NUM>. The contour portion <NUM> configured to fit flush with the tray <NUM> or engage with the frame of the stand <NUM> that supports the tray <NUM>. As shown, the contour portion <NUM> comprises a rectangular shape; however, the contour portion <NUM> may comprise any shape that allows the cushion device <NUM> to be removably secured to the medical instrument stand <NUM>. In some embodiments, the contour portion <NUM> may comprise a rectangular shape while the back portion <NUM>, front portion <NUM>, and side portions <NUM> may collectively define a shape different from that of the contour shape (e.g., circular, semi-circular, triangular, polygonal, etc). The contour portion <NUM> may have dimensions that allow it to suitably engage with a tray <NUM> of the medical device stand <NUM>. Thus, the other portions of the cushion device <NUM> may comprise dimensions that are larger than those of the contour portion <NUM>.

The contour portion <NUM> may be formed of the same material as the other components/portions of the device <NUM>. Alternatively, the contour portion <NUM> may comprise a base foam layer that is more rigid in comparison to one or more other components/portions of the device <NUM>, such as compared to a top layer of foam forming the upper portion <NUM>. A more rigid base layer may be utilized to provide a stable operating and/or positioning surface. In some embodiments, the base is a cross-linked polyethylene foam.

The contour portion <NUM> may have an indentation load deflection (ILD) of at least about <NUM> pounds, more preferably at least about <NUM> pounds or at least about <NUM> pounds, such as an ILD within a range of about <NUM> to about <NUM> pounds, or about <NUM> to <NUM> pounds, or about <NUM> to about <NUM> pounds. The density of the contour portion <NUM> may be about <NUM> to about <NUM> PCF, such as about <NUM> to about <NUM> PCF. In some embodiments, the contour portion 112may be formed from a #<NUM> XLPE (cross-linked polyethylene) and/or other foam material(s) having similar density and ILD properties.

In some embodiments, a base portion of the cushion device may comprise a material that has sufficient firmness that allows it to provide some structural support to the cushion device <NUM> for use in as a stable operating surface but to also compress somewhat under typical patient weight. Thus, a layer of the cushion device <NUM> may be formed from #<NUM> XLPE and/or other foam material(s) having similar density and ILD properties.

<FIG> illustrate opposing side views of the cushion device <NUM>, showing side portions <NUM> and showing rim <NUM> extending vertically upward from side portions <NUM>. The rim <NUM> may extend from one side portion <NUM> (see <FIG>) to a height greater or less than the height to which the rim <NUM> extends from the opposite side portion <NUM> (see <FIG>).

In some embodiments, the cushion device <NUM> is configured with multiple layers of foam that may have different density. Additionally, or alternatively, the cushion device <NUM> may comprise a single layer or multiple layers of uniform density foam.

While certain embodiments of the present disclosure have been described in detail, with reference to specific configurations, parameters, components, elements, etcetera, the descriptions are illustrative and are not to be construed as limiting.

Furthermore, it should be understood that for any given element of component of a described embodiment, any of the possible alternatives listed for that element or component may generally be used individually or in combination with one another, unless implicitly or explicitly stated otherwise.

In addition, unless otherwise indicated, numbers expressing quantities, constituents, distances, or other measurements used in the specification and claims are to be understood as optionally being modified by the term "about" or its synonyms. When the terms "about," "approximately," "substantially," or the like are used in conjunction with a stated amount, value, or condition, it may be taken to mean an amount, value or condition that deviates by less than <NUM>%, less than <NUM>%, less than <NUM>%, or less than <NUM>% of the stated amount, value, or condition. At the very least, each numerical parameter should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

Any headings and subheadings used herein are for organizational purposes only and are not meant to be used to limit the scope of the description.

It will also be noted that, as used in this specification, the singular forms "a," "an" and "the" do not exclude plural referents unless the context clearly dictates otherwise. Thus, for example, an embodiment referencing a singular referent (e.g., "widget") may also include two or more such referents.

It will also be appreciated that embodiments described herein may include properties, features (e.g., ingredients, components, members, elements, parts, and/or portions) described in other embodiments described herein. Accordingly, the various features of a given embodiment can be combined with and/or incorporated into other embodiments of the present disclosure. Thus, disclosure of certain features relative to a specific embodiment of the present disclosure should not be construed as limiting application or inclusion of said features to the specific embodiment. Rather, it will be appreciated that other embodiments can also include such features.

Claim 1:
A cushion device (<NUM>) configured for placement on a medical instrument stand (<NUM>), the cushion device (<NUM>) comprising:
an upper portion (<NUM>) having a front side, a rear side, first and second longitudinal sides, an upper surface, and a bottom surface;
a front portion (<NUM>) connected to the front side of the upper portion (<NUM>) and extending downwards therefrom and below the bottom surface;
first and second side portions (<NUM>) each connected respectively to the first and second longitudinal sides of the upper portion (<NUM>) and extending downward therefrom and below the bottom surface; and
a hollow receptacle defined by an inner surface of the front portion (<NUM>) extending downwards and below the upper portion (<NUM>), opposing inner surfaces of the first and second side portions (<NUM>) extending downwards and below the upper portion (<NUM>), and the bottom surface of the upper portion (<NUM>), wherein the hollow receptacle is configured in size and shape to fit over and receive therein a medical instrument tray or portion of a frame of a medical instrument stand (<NUM>) associated with a medical instrument tray (<NUM>).