Surgical drapes for heat treatment bowls

Abstract

To provide a drape for equipment used during a medical procedure.SOLUTION: A drape for equipment used during a medical procedure may be formed of a flexible sheet of polymeric material. The flexible sheet can have a basin portion that is shape-indexed to a basin or reservoir of the equipment over which the drape is intended to be draped. The flexible sheet can also have a side sheet portion connected to the basin portion. The side sheet portion can drape down the basin or reservoir of the equipment over which the drape is draped. The basin portion of the flexible sheet can be collapsible. As a result, the drape can be collapsed into a planar package for storage. Upon being removed from the package, the basin portion of the drape can be expanded to conform to walls of the basin of the equipment over which the drape is deployed.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] cross reference This application claims priority to U.S. Provisional Patent Application No. 62 / 564,229, filed September 27, 2017, the entire contents of which are incorporated herein by reference.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to surgical drapes, and more particularly to surgical drapes used to cover medical instruments during procedures. [Background technology]

[0003] Disposable surgical drapes are used during medical procedures to help establish or maintain a sterile field, reducing the likelihood of a patient receiving a procedure contracting an infection from a contaminated surface or object. For example, a sterile surgical drape may be deployed over the equipment used in an operating room or other medical environment before the procedure begins. The sterile surgical drape can provide a barrier between materials introduced to and / or removed from the patient during the procedure and the equipment used during the procedure. While the equipment itself can be sterilized before use, the addition of a sterile surgical drape can reduce the likelihood of the patient becoming contaminated and acquiring a hospital-acquired infection during the procedure. Summary of the Invention [Problem to be solved by the invention]

[0004] In practice, sterile surgical drapes are provided as pre-packaged, disposable items. They can be packaged small enough for convenient transport and storage. However, they may have an unpackaged size sufficient to cover the intended medical device. To help avoid contact contamination during deployment of the sterile surgical drape, the drape can be folded and packaged to minimize contact of the sterile surface by the user deploying the drape. [Means for solving the problem]

[0005] In general, the present disclosure is directed to surgical drapes and techniques for folding surgical drapes for convenient packaging and unfolding surgical drapes for sterile deployment. In some examples, the surgical drape is designed to cover the basin of a surgical system, such as a system for thermally treating surgical fluids prior to their use during a medical procedure. The surgical fluid may be temperature conditioned within the system to elevate its temperature above ambient or lower its temperature below ambient. The system can also maintain the surgical fluid at an elevated or reduced temperature relative to ambient until it is ready to be used during the procedure. During use, the surgical fluid may be aspirated from the basin and dispensed onto a surgical site on or within a patient to irrigate the site and flush away bodily material.

[0006] In some examples, a drape according to the present disclosure includes a thermoformed bowl and side sheets coupled to the thermoformed bowl. The thermoformed bowl can be shape-indexed to the shape of the bowl of the surgical system. The thermoformed bowl can be formed of a polymeric material and can be thin enough to be foldable. In some configurations, for example, the drape can be defined by a bottom wall and foldable side walls. To facilitate compact packaging, the side walls and / or bottom wall of the drape can be folded into a substantially flat package. However, after removal from the package, the side walls and / or bottom can expand to define a shape-indexed bowl portion of the drape that can be inserted into the bowl of the thermal treatment system. In this way, the drape can define a compact package for shipping and / or storage, yet can expand to include a bowl portion that would otherwise occupy more space.

[0007] Drapes according to the present disclosure can have a variety of different features as described herein, but in some configurations, the drape includes a flexible window portion. The flexible window portion may be thermally bonded between the thermoformed bowl portion and the flexible side sheet portion of the drape. The window portion may be positionable over a user input device (e.g., a display screen) of a thermal treatment system on which the drape is deployed. The window portion may be formed of a polymer that is visually transparent to the user. Depending on the type of polymer used, the polymer may contain a tackifier to increase the adhesion and / or friction of the window (e.g., compared to other portions of the drape). This helps prevent the window from sliding against the user interface over which it is positioned when a user interacts with the user interface through the window.

[0008] As another exemplary feature, the drape may include an electronically readable tag embedded in the drape. For example, the electronically readable tag may be located in a pocket formed by joining two sheets of material together. The electronically readable tag may be oriented relative to the bowl portion such that when the drape is placed over the thermal treatment system, the electronically readable tag is located over a contactless reader. This arrangement can provide a securely attached electronically readable tag that is properly located relative to the thermal treatment system by inserting the bowl portion of the drape into the bowl of the thermal treatment system, without requiring special positioning by an operator.

[0009] In one example, a drape for a surgical fluid thermal treatment system is described. The drape includes a flexible sheet having a bowl portion and a side sheet portion connected to the bowl portion. The bowl portion defines a bottom wall and a foldable side wall. The foldable side wall is configured to transform from a first configuration in which the bowl portion is expanded to fit within the bowl of the surgical fluid thermal treatment system to a second configuration in which the bowl portion is folded and the flexible sheet is planar.

[0010] Another example describes a drape that includes a thermoformed bowl that is shape-indexed to the shape of the bowl of a surgical system into which the thermoformed bowl is configured to be inserted. This example specifies that the thermoformed bowl is foldable. Furthermore, this example specifies that the drape includes flexible side sheets that are bonded to and extend around the entire periphery of the thermoformed bowl.

[0011] In another example, a method is described that includes removing a folded, flat drape from a sealed package, inserting a bowl portion of the drape into a bowl of a surgical fluid heat treatment system, and expanding the bowl portion of the drape from a folded configuration to an expanded configuration.

[0012] In another example, a method for folding a drape is described. The method includes providing a drape including a collapsible bowl and flexible side sheets extending around the periphery of the collapsible bowl, the flexible side sheets having a first edge and a second edge on the flexible side sheet opposite the first edge. The method includes configuring the drape so that the collapsible bowl is folded to be substantially planar, and folding the first edge of the drape toward the second edge of the drape to form a first fold line across the collapsible bowl. The method also includes folding the first edge of the drape back from the second edge of the drape to form a second fold line offset from the first fold line, thereby providing a first drape panel positioned over the collapsible bowl. The method further includes folding a first edge of the drape toward a second edge of the drape to form a third fold line offset from the second fold line, and folding the first edge of the drape back from the second edge of the drape to form a fourth fold line offset from the third fold line, thereby providing a second drape panel for placement over the collapsible bowl.

[0013] The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims. [Brief explanation of the drawings]

[0014] [Figure 1] 1 is a perspective view of an exemplary surgical system that may be draped in accordance with the present disclosure;

[0015] [Figure 2] FIG. 1 is a perspective view of an exemplary drape. [Figure 3] FIG. 1 is a perspective view of an exemplary drape.

[0016] [Figure 4] 4A and 4B are side and perspective views, respectively, illustrating an exemplary layout of a bowl portion that can be used with the drapes of FIGS. 2 and 3. [Figure 5] 4A and 4B are side and perspective views, respectively, illustrating an exemplary layout of a bowl portion that can be used with the drapes of FIGS. 2 and 3.

[0017] [Figure 6] 4 is a perspective view showing an exemplary arrangement of a window portion relative to a bowl portion that can be used in the drape of FIGS. 2 and 3. FIG.

[0018] [Figure 7] 10A-10C are cross-sectional views illustrating exemplary bowl portion configurations with different bowl portion thicknesses.

[0019] [Figure 8] 4 is a perspective view illustrating an exemplary folded configuration of the drape of FIGS. 2 and 3. FIG.

[0020] [Figure 9] FIG. 10 is a perspective view of an exemplary portion of a drape showing how an electronically readable tag can be positioned on the drape.

[0021] [Figure 10] 10A-10C illustrate examples of folding and packaging steps that can be utilized for drapes according to the present disclosure. [Figure 11] 10A-10C illustrate examples of folding and packaging steps that can be utilized for drapes according to the present disclosure. [Figure 12] 10A-10C illustrate examples of folding and packaging steps that can be utilized for drapes according to the present disclosure. [Figure 13] 10A-10C illustrate examples of folding and packaging steps that can be utilized for drapes according to the present disclosure. [Figure 14] 10A-10C illustrate examples of folding and packaging steps that can be utilized for drapes according to the present disclosure. [Figure 15] 10A-10C illustrate examples of folding and packaging steps that can be utilized for drapes according to the present disclosure. [Figure 16] 10A-10C illustrate examples of folding and packaging steps that can be utilized for drapes according to the present disclosure. [Figure 17] 10A-10C illustrate examples of folding and packaging steps that can be utilized for drapes according to the present disclosure. [Figure 18] 10A-10C illustrate examples of folding and packaging steps that can be utilized for drapes according to the present disclosure. [Figure 19] 10A-10C illustrate examples of folding and packaging steps that can be utilized for drapes according to the present disclosure. [Figure 20] 10A-10C illustrate examples of folding and packaging steps that can be utilized for drapes according to the present disclosure. [Figure 21] 10A-10C illustrate examples of folding and packaging steps that can be utilized for drapes according to the present disclosure. [Figure 22] 10A-10C illustrate examples of folding and packaging steps that can be utilized for drapes according to the present disclosure. [Figure 23] 10A-10C illustrate examples of folding and packaging steps that can be utilized for drapes according to the present disclosure. [Figure 24] 10A-10C illustrate examples of folding and packaging steps that can be utilized for drapes according to the present disclosure. [Figure 25] 10A-10C illustrate examples of folding and packaging steps that can be utilized for drapes according to the present disclosure. [Figure 26] 10A-10C illustrate examples of folding and packaging steps that can be utilized for drapes according to the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0022] The present disclosure is generally directed to drapes used to protect medical instruments. In some examples, drapes according to the present disclosure are individually pre-packaged and sterilized to be free of bacteria or other organisms. The drapes can be subjected to heat and / or chemical treatments (e.g., exposure to ethylene oxide) to provide a sterilized drape that can be placed over medical instruments in a surgical environment to establish a sterile field over the medical instruments so covered. The drape can be discarded after use, and a new drape is used during subsequent medical procedures, or, in the case of lengthy procedures, for later portions of the same medical procedure.

[0023] In some examples, the drape is comprised of a bowl portion and a side sheet portion. The side sheet portion can be operably connected to the bowl portion and, in some configurations, extends outward away from the bowl portion. The entire drape may be formed of flexible sheet material(s) that can be deformed by the pressure of a human hand. For example, the drape may be folded into a compact, substantially flat package with the bowl portion folded onto itself and the side sheet portion folded over the folded bowl. During use, an operator can remove the drape from the package and insert the folded bowl portion over the corresponding medical device to be covered. The operator can expand the folded bowl portion to its expanded shape, causing the walls of the bowl portion to substantially conform to the corresponding medical device to be covered. The side sheet portion can hang downward over the medical device. Configuring a drape with a foldable bowl can, among other features, provide a more compact package for transportation and storage than if the drape structure were manufactured by attaching a flexible plastic drape around a rigid bowl.

[0024] While drapes according to the present disclosure can be used to cover any type of instrument that is desirably covered during use, the present drapes can be particularly useful for covering instruments used in medical environments to provide a sterile drape surface over the instrument. Reference to a medical, surgical, or operating environment includes a hospital, clinic, facility, or location where disease or injury is diagnosed or treated using interventional or non-interventional techniques. Examples of medical instruments that can be covered using drapes having bowl portions according to the present disclosure include, but are not limited to, sink basins, measuring troughs for measuring substances introduced to or removed from a patient, bowls for holding materials used during surgical procedures (e.g., tools, swabs), etc.

[0025] As one particular example, a drape can be deployed over a system for thermally treating a surgical fluid prior to utilizing the fluid during a medical procedure. The surgical fluid may be temperature conditioned within the system to either elevate the temperature above ambient or lower the temperature below ambient. The system can also maintain the surgical fluid at an elevated or reduced temperature relative to ambient until the surgical fluid is ready to be used during the procedure.

[0026] FIG. 1 is a perspective view of an example of a system 10 for thermally treating a surgical fluid that may be covered with a drape according to the present disclosure. In the example of FIG. 1, the system 10 includes a base 12 and a bowl 14. The bowl 14 is supported by and rises vertically above the base 12. The bowl 14 can provide an open reservoir into which the surgical fluid can be dispensed or into which other materials being treated can be introduced. Once added to the bowl 14, the surgical fluid can be temperature regulated within the bowl. For example, the bowl 14 can be thermally coupled to a thermal treatment device that can increase or decrease the temperature of the thermal fluid. The bowl 14 can also maintain the surgical fluid at a target temperature until it is removed from the bowl and used in the procedure. In some examples, the system 10 can heat the surgical fluid in the bowl 14 to a temperature close to the patient's normal body temperature, such as between 90°F (32.2°C) and 120°F (48.9°C), e.g., between 95°F (35°C) and 105°F (40.6°C).

[0027] To allow an operator to interact with system 10 and control different settings, system 10 may include a user interface. In the example of FIG. 1 , system 10 includes at least one user interface 16. User interface 16 may include user inputs through which a clinician enters information into system 10 and user outputs through which the clinician receives information from the system. For example, user interface 16 may include one or more operable inputs with which a clinician can interact to adjust settings of system 10, provide an indication that fresh fluid is being added to bowl 14, provide an indication that a non-surgical component is being added to or removed from system 10, change the temperature to which fluid in bowl 14 is heated, etc. The operable user inputs may be implemented as physically depressible buttons (e.g., switches), portions of a touchscreen with which the clinician can interact, or other features with which the clinician can interact to communicate information to system 10. The user output of user interface 16 may be a display that provides graphical and / or textual information regarding the operation of system 10.

[0028] In applications in which system 10 includes a display, the system may be configured with a single display or multiple displays. In FIG. 1 , system 10 is shown as having a first display forming part of user interface 16 and a second display 18. The first display is positioned on the exterior surface of one side of bowl 14, while the second display is positioned on the exterior surface of substantially the opposite side of the bowl. This arrangement may be useful to allow clinicians working on different sides of bowl 14 to view information related to the operation of system 10. In some examples, second display 18 is part of a user interface that includes the same features and functionality (e.g., user input(s) and / or user output(s)) as first user interface 16. This may allow clinicians working on either side of the system to present information to and receive information from system 10. In other examples, second display 18 may be a display that provides user output but does not have user input controls. In these applications, the clinician may enter information or commands through user input(s) on the user interface 16, but can view output information on both displays.

[0029] Any type of substance may be introduced into and removed from bowl 14 during a medical procedure, including any type of surgical fluid. Exemplary types of medical fluids that may be used during a medical procedure include water, saline, and the like. Surgical fluids may or may not contain agents, such as compounds that impart antibacterial, anticoagulant / clotting, anesthetic properties, and the like. Alternative substances that may be introduced into bowl 14 may include a medical specimen extracted from a patient for weighing (e.g., in embodiments in which the bowl is configured to measure weight), blood, platelets, or substances for thermal regulation before introduction into a patient, or non-medical-related substances (e.g., in applications in which system 10 is not used in a medical environment). Additionally or alternatively, medical tools, such as Acepto valve syringes and / or graduated measuring containers, may be added to and removed from bowl 14 during use.

[0030] 1 , bowl 14 is supported by and elevates vertically above base 12. Specifically, bowl 14 is mounted on elongated housing 20 that extends vertically upward from base 12. Base 12 and housing 20 enable bowl 14 to be elevated to a position convenient for a clinician to interact with the bowl. Further details regarding exemplary thermal treatment systems can be found in U.S. Patent Application No. 15 / 469,476, filed March 24, 2017, the entire contents of which are incorporated herein by reference.

[0031] Regardless of the configuration of the device to be covered, drapes according to the present disclosure can have a variety of different features and configurations, as discussed herein. Figures 2 and 3 are perspective views of an exemplary drape 30 that can be used to cover the system 10 of Figure 1 or any other desired device. Figure 2 is an exploded perspective view of the drape 30, and Figure 3 shows the drape in its assembled form. As shown, the drape 30 can be formed from a flexible sheet of material 32 having a bowl portion 34 and side sheet portions 36. The side sheet portions 36 can at least partially, and in the illustrated example, entirely, surround the periphery of the bowl portion 34. The side sheet portions 36 can be physically connected to the bowl portion 34 to define a single, uninterrupted sheet surface. In some configurations, such as those shown in Figures 2 and 3, the drape 30 includes one or more window portions 38, 40. The window portions 38, 40 of the drape 30 may be configured and designed to be positioned over a visible and / or interactable feature of the covered device, such as the user interface 16 and / or display 18 of the system 10 of FIG. 1 .

[0032] The bowl portion 34 of the drape 30 may be foldable to facilitate flat folding and packaging of the drape 30 and expandable to facilitate insertion of the bowl portion into the bowl to be covered during use. The bowl portion 34 in Figures 2 and 3 is shown in an expanded configuration in which the bowl portion defines its maximum volume, such as the configuration when the drape is in use and the bowl portion 34 of the drape 30 is inserted into the bowl 14 of the system 10. The bowl portion 34 of the drape 30 may be foldable so that the bowl portion collapses into a more compact shape that is substantially flat (e.g., Figure 7).

[0033] The bowl portion 34 of the drape 30 may define a reservoir that receives and retains surgical fluids or other materials inserted into a covered instrument with the drape positioned therebetween. The bowl portion 34 of the drape 30 can define any polygonal (e.g., rectangular, square, hexagonal) or arcuate (e.g., circular, elliptical) shape, or even a combination of polygonal and arcuate shapes. In the example shown, the bowl portion 34 is shown as a generally oval shape and includes a bottom wall 42 and at least one side wall 44 extending vertically upwardly away from the base (e.g., when the bowl portion is expanded rather than collapsed). The bottom wall 42 and side wall 44 collectively form a bounded recess with an open upper surface that receives and retains materials inserted into a covered instrument with the drape positioned therebetween.

[0034] The side sheet portions 36 of the drape 30 can be connected to the bowl portion 34 and extend outward and / or downward away from the bowl portion. For example, the bowl portion 34 can define a perimeter 46 that delimits the bowl portion. The perimeter 46 of the bowl portion 34 can be where the bowl portion transitions from a vertical sidewall that defines the depth or height of the reservoir (e.g., when in the expanded configuration) to a horizontal sidewall. In either case, the side sheet portions 36 can be physically connected to the perimeter 46 of the bowl portion, for example, directly or indirectly with windows 38, 40 disposed between the perimeter and the side sheet portions. The side sheet portions 36 can be flexible and can sag or hang downward by gravity over the appliance on which the drape is placed. For example, when drape 30 is deployed over system 10 of FIG. 1 , bowl portion 34 can be inserted into bowl 14 of the system with side sheet portions 36 facing downward and covering at least a portion of the exterior surface of bowl 14 and / or housing 24.

[0035] In general, the bowl portion 34 of the drape 30 may be shape-indexed to the shape of the bowl or reservoir into which the bowl portion 34 is intended to be inserted. The bowl portion 34 may be shape-indexed in that it may have a size and / or shape complementary to the reservoir or bowl of the appliance to be covered and into which the bowl portion 34 is intended to be inserted. For example, the bowl portion 34 may be shape-indexed so that the bottom wall 42 and side walls 44 physically contact and / or conform to corresponding walls of the structure into which the covered bowl portion will be inserted (e.g., the bowl 14 of the system 10 of FIG. 1 ). Matching the shape of the bowl portion 34 to the structure into which it is intended to be inserted may be useful, for example, to promote efficient heat transfer between the heated or cooled walls of the structure and the material contained in the bowl portion 34 whose temperature is to be regulated.

[0036] The shape of bowl portion 34 can be established by the configuration of bottom wall 42 and at least one side wall 44. Generally, side wall 44 extends upwardly from bottom wall 42. The number of side walls interconnected together to form the lateral structure of bowl portion 34 can vary depending on the shape of the reservoir. For example, a bowl portion having a circular cross-sectional shape (e.g., in a horizontal plane) may be formed by a single side wall, while a bowl portion having a square or rectangular cross-sectional shape may be defined by four interconnected side walls.

[0037] In some examples, at least one sidewall 44 defining the bowl portion 34 is sloped such that the sidewall extends vertically upward and outward away from the bottom wall 42. For example, the sidewall 44 may be curved and may define a radius of curvature where the sidewall intersects and joins the bottom wall 42. The bottom wall 42 may be flat, curved, or have another suitable shape profile. Configuring the sidewall 44 with a curved or sloped profile instead of a straight sidewall may help prevent material from accumulating at corners where the sidewall 44 intersects the bottom wall 42. For example, the bowl portion 34 may define an arcuate shape without a 90° angle to help prevent material from accumulating in such angular areas. That said, in other examples, the sidewall 44 may not be curved and may instead be straight (e.g., perpendicular to the ground).

[0038] 4 and 5 are side and perspective views, respectively, of bowl portion 34, illustrating an exemplary layout of the bowl portion. As shown in this example, sidewalls 44 define a radius of curvature 45 where the sidewalls extend outward from and join bottom wall 42. When so configured, bowl portion 34 may define an open top surface 48 having a cross-sectional area 50 larger than the cross-sectional area 52 defined by bottom wall 42. Configuring bowl portion 34 so that open top surface 48 defined by the bowl portion is larger than bottom wall 42 can be useful for providing space for the bowl portion to fold into a compact profile. For example, bowl portion 34 may be telescopically folded with bottom wall 42 positioned substantially flush with perimeter 46 and sidewalls 44 nested or folded within a ring of folded / gathered material between the bottom wall and the sidewall upper ends.

[0039] In some configurations, such as those shown in FIGS. 4 and 5 , the sidewall 44 extends vertically upward from the bottom wall 42, defining a curved peripheral lip 54. The curved peripheral lip 54 can be a transition region of the sidewall 44 that transitions from a generally vertical orientation to a generally horizontal orientation. In some examples, the curved peripheral lip 54 of the bowl portion 34 can transition the sidewall 44 from a generally upward vertical orientation to a generally horizontal orientation to a generally downward vertical orientation. For example, the sidewall 44 may extend upward from the bottom wall 42 to an inflection point 56 and then extend downward from the inflection point toward the ground (e.g., when placed on a covered object). The weight of the side sheet portions 36 drooping toward the ground due to gravity can help impart this curvature to the peripheral lip of the bowl portion 34. Configuring the bowl portion 34 with a curved peripheral lip can be useful to help the bowl portion cover the top surface of the bowl or reservoir of an appliance covered by the drape 30.

[0040] Although drape 30 is shown as having a single bowl portion 34 that is inserted into a corresponding bowl of the covered device, the drape may be formed with multiple bowl portions separated from one another by walls of material. For example, bowl portion 34 may be a single cavity with internal partition(s) or divider(s) that separate one or more reservoir cavities from fluid communication with one or more other reservoir cavities. Alternatively, drape 30 may include multiple bowl portions 34 that are separated from one another but physically joined together.

[0041] As mentioned above, the drape 30 may include at least one window portion, shown as two window portions 38, 40 in the example of FIGS. 2 and 3. Each window portion is a transparent area configured to be positioned over a user interface feature of a covered device. For example, the drape 30 may include a first window portion 38 configured to be positioned over the user interface 16 of the system 10 (FIG. 1) and a second window portion 40 configured to be positioned over the display 18 of the system 10. By configuring the drape 30 with transparent window portions 38, 40, a user may be able to better view and / or interact with the features of the device located below the respective window portion.

[0042] If the drape 30 includes a window portion, the location of the window portion relative to the bowl portion 34 may vary depending on the configuration of the appliance it is intended to cover. In some examples, the drape 30 includes at least one window portion disposed between the bowl portion 34 and the side sheet portion 36. The window portion may be connected to the bowl portion 34 and the side sheet portion 36, collectively forming a continuous draped surface.

[0043] 6 is a perspective view of bowl portion 34 showing an exemplary arrangement of window portions 38 and 40 relative to the bowl portion. As shown, bowl portion 34 defines a perimeter 46 having a length 58 and a width 60. In the configuration shown, first window portion 38 projects away from one longitudinal perimeter section of bowl portion 34. Second window portion 40 projects away from the opposite longitudinal perimeter section of bowl portion 34. In this arrangement, the window portions do not project away from the lateral perimeter sections of the bowl portion, although other window arrangements may be used without departing from the scope of this disclosure.

[0044] In the arrangement of Figure 6, bowl portion 34 is shown as defining an oval recess formed collectively by bottom wall 42 and sidewall 44. The oval recess transitions to a generally rectangular shape around perimeter 46. For example, peripheral lip 54 of sidewall 44 is shown as transitioning from an oval cross-sectional shape to a generally rectangular cross-sectional shape. While the corners of the generally rectangular perimeter shape of bowl portion 34 are shown as chamfered or rounded, they may intersect at sharp (e.g., 90°) angles in other configurations.

[0045] The drape 30 can be made from any suitable material, but typically the drape will be made from one or more polymeric materials. Examples of polymers that can be used to make the drape 30 include, but are not limited to, polyethylene, polypropylene, polyvinyl chloride, polystyrene, polyamide, polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), polyurethane, and combinations thereof.

[0046] The particular material(s) used to form drape 30 may be selected based on the drape's desired performance characteristics, such as its chemical and / or heat resistance, its puncture resistance, its flexibility, or additional performance characteristics. For example, if drape 30 is intended to cover an appliance that regulates the temperature of contents contained in bowl portion 34 relative to the ambient temperature, at least bowl portion 34 may be selected for temperature compatibility with the covered appliance. In some examples, drape 30 and / or the drape's bowl portion 34 may be formed of a polymer having a melting temperature above 100°F, such as above 120°F, above 130°F, or above 150°F. This may be useful for covering a water heater, such as the exemplary heater shown in FIG. 1, in applications where the contents contained in bowl portion 34 are heated to temperatures near or slightly above the temperature of the human body.

[0047] In some examples, each portion of the drape 30 (e.g., the bowl portion 34, the side sheet portion 36, and the windows 38, 40) are formed of the same polymer. In other examples, at least a portion of the drape 30 may be formed of a different polymer composition than at least one (and optionally all) of the other portions forming the drape. For example, the bowl portion 34 may be formed of a first polymer composition, the windows 38, 40 may be formed of a second polymer composition, and the side sheet portion 36 may be formed of a third polymer composition. The first, second, and third polymer compositions may each be different from one another. For example, each polymer composition may be formed from a different type of monomer, or multiple (e.g., all) polymer compositions may be formed from the same type of monomer with different components included in the formulation to result in different compositions.

[0048] As an example, the first, second, and third polymer compositions may each be formed from polyurethane monomers but may have different formulations to provide distinct compositions. The prepolymerized resins used to produce the first, second, and third polymer compositions may contain a common polyurethane monomer but may include different additives and / or components. Additionally or alternatively, the type and / or degree of polymerization may differ between the different polymer compositions used to produce different portions of the drape 30.

[0049] In some examples, the second polymer composition used to manufacture the window portions 38, 40 is selected to have tackier surface properties than the first polymer composition used to manufacture the bowl portion 34 and the third polymer composition used to manufacture the side sheet portions 36. For example, the second polymer composition may have a tackifier (e.g., a different amount and / or a different composition than the first and third polymer compositions) that affects the tack of the window portions 38, 40. Examples of tackifiers that may be used include, but are not limited to, aliphatic hydrocarbon resins, rosin esters, and rosin acids; mixed aliphatic / aromatic tackifying resins; polyterpene tackifiers; and hydrogenated tackifying resins, such as those produced from the polymerization and subsequent hydrogenation of aromatic feedstocks such as styrene, α-methylstyrene, and vinyltoluene.

[0050] Fabricating the window portions 38, 40 from a polymer composition that imparts adhesion and / or resistance to sliding friction can be useful for facilitating user interaction with the covered device portion underneath the window portions 38, 40. A relatively higher adhesion of the window portions 38, 40 than the bowl portion 34 and / or the side sheet portion 36 can be useful for helping prevent the window portions from moving when a user presses one of the window portions to interact with a device feature underneath. For example, if a window portion is placed over a user interface of a covered device, the user can press the window portion to engage the user interface covered by the window portion. In some examples, the material(s) used to fabricate the window portion of the drape 30 may exhibit a coefficient of friction greater than 1 according to ASTM D1894 and / or be too adhesive to be tested according to that standard.

[0051] Depending on the type of material(s) selected to manufacture different portions of the drape 30, the different portions may have any degree of optical transparency, ranging from transparent to opaque in each case within the visible light spectrum. For example, the drape 30, or any portion thereof, may be transparent, translucent, or opaque. In some examples, the window portions 38, 40 are transparent, and the side sheet portion 36 is transparent or translucent. This configuration may help the user see the features and / or components of the device covered beneath the window portion and / or side sheet portion. Additionally, any portion of the drape 30 may or may not be colored, for example, by incorporating a dye or pigment into the polymer composition forming the drape. The drape 30, or portions thereof, such as the side sheet portion 36, may be blue to help visually indicate that the drape defines a sterile field.

[0052] When the drape 30 is formed from one or more polymeric materials, polymer processing techniques may be used to manufacture the drape, or any portion thereof. For example, the drape 30 may be formed using casting, extrusion, calendaring, and / or other polymer processing techniques. In some examples, the drape 30, or any portion thereof, is formed from an extruded polymer film, which may be a monolayer film or a multilayer film of the same or different chemical compositions.

[0053] Additionally or alternatively, the bowl portion 34 of the drape 30 may be formed using thermoforming techniques to produce a thermoformed bowl. Thermoforming generally involves heating a plastic sheet until it becomes flexible (e.g., optionally above its glass transition temperature) and stretching it over a mold having the inverse shape of the shape desired to be imparted to the thermoformed sheet. The polymer sheet can have the shape of the mold to which it is imparted upon cooling, resulting in, for example, the thermoformed bowl portion 34. The thermoforming process may be carried out under vacuum or positive pressure. When vacuum thermoforming is performed, a plastic sheet may be heated until it becomes flexible (e.g., optionally above its glass transition temperature) and then vacuumed into a mold having the same shape as the shape desired to be imparted to the thermoformed sheet.

[0054] Although the bowl portion 34 of the drape 30 may be formed using other polymer molding techniques, such as injection molding, blow molding, or rotational molding, thermoforming can be useful for producing a bowl portion having a thinner thickness than can be obtained using other polymer molding techniques. The bowl portion 34 of the drape 30 can be more easily folded when formed from a thinner gauge material than when formed from a thicker gauge material that cannot be folded into a flat shape, facilitating packaging and storage.

[0055] While the drape 30 and its portions may be formed from a material of any suitable thickness, in some instances, the bowl portion 34 is fabricated from a thicker material than the side sheet portions 36. Fabricating the bowl portion 34 from a thicker material may help prevent surgical tools or other potentially sharp objects placed in the bowl portion 34 from puncturing the drape during use. In contrast, fabricating the side sheet portions 36 from a relatively thin material may increase the flexibility of the side sheet portions, helping them to drape downward over objects covered by the drape 30.

[0056] In some configurations, the bowl portion 34 has a thickness ranging from 0.05 mm to 1 mm, such as from 0.1 mm to 0.5 mm. The side sheet portions 36 may have a thickness of less than 0.2 mm, such as less than 0.15 mm, or less than 0.05 mm. For example, the side sheet portions 36 may have a thickness ranging from 0.025 mm to 0.15 mm, such as from 0.05 mm to 0.08 mm. The window portions of the drape 30 (such as window portions 38, 40, if included) can have a thickness that is substantially equal to or even different from the thickness of the side sheet portions 36, bowl portion 34. For example, the window portion(s) of the drape 30 can have a thickness that is less than the thickness of the side sheet portions 36 and / or bowl portion 34. The window portion(s) can have a thickness that is less than the thickness of the side sheet portions 36 and / or bowl portion 34. The window portion(s) can have a thickness that makes the screen and / or button below the window tactile and detectable to a user pressing the screen and / or button through the window. In some examples, the window portion(s) of the drape 30 may have a thickness ranging from 0.05 mm to 0.1 mm. The thickness of each portion of the drape 30 may be constant throughout the drape or may vary throughout the drape.

[0057] FIG. 7 is a cross-sectional view of bowl portion 34 illustrating an exemplary configuration of a bowl having a varying bowl thickness. In this example, bowl portion 34 defines a maximum thickness 62 at its periphery 46. The thickness of the material forming bowl portion 34 tapers to a minimum thickness 64 at bottom wall 42. While FIG. 7 illustrates the material thickness gradually and continuously decreasing along sidewall 44 between periphery 46 and bottom wall 42, in other configurations, the taper may be discontinuous or may be to a different extent than shown in the exemplary diagram. The material forming bowl portion 34 may be tapered during the thermoforming process when the polymer sheet used to form the bowl portion is stretched to assume the bowl shape. This allows for a thinner material over the area defining the bowl's recess, which is not substantially deformed during the thermoforming process, compared to the substantially horizontal / planar periphery of the bowl portion.

[0058] In some examples, the thickness of sidewall 44 varies from a maximum thickness 62 of 0.4 mm or more to a minimum thickness 64 of less than 0.4 mm where the sidewall joins bottom wall 42. For example, maximum thickness 62 of sidewall 44 may range from 0.4 mm to 0.7 mm. Minimum thickness 64 of sidewall 44 may range from 0.1 mm to 0.2 mm. Thus, the ratio of the maximum thickness divided by the minimum thickness of bowl portion 34 may range from 2 to 10, such as 3 to 5, although other thickness ratios may be used.

[0059] Regardless of whether the thickness of the sidewall 44 of the bowl portion 34 is constant or variable, the thickness may be small enough to allow the bowl portion sidewall to be folded. The sidewall 44 may be folded by deforming the sidewall with human hand pressure, causing the sidewall to lose structural rigidity and fold or wrinkle upon itself. The sidewall 44 may be reversibly expanded by applying an expansion force with human hand pressure that opposes the deformation force, thereby stretching and / or elongating the folded or wrinkled sidewall to assume its expanded wall-like structure. In a different example, the bottom wall 42 of the bowl portion 34 may be rigid or may be as flexible and foldable as the sidewall 44 (or more).

[0060] In practice, the drape 30 may be fabricated from a single sheet of material (which may itself be a single layer of material, or multiple layers of material integrally bonded together, such as by coextrusion), or may be fabricated from different sections of material joined together. For example, each portion of the drape 30 (e.g., the side sheet portion 36, the bowl portion 34, the windows 38, 40) may be formed separately (e.g., from separate sections of material) and joined together to form the drape 30. Alternatively, the drape 30 may be formed from a single, piece of material, with the bowl portion 34 formed to define the drape. Thus, while different portions of the drape 30 are described herein as being connected together, it should be understood that these portions may be physically connected by being part of a common sheet of material, or may be physically connected by bonding different sheets or sections of material together to form the drape 30.

[0061] In some examples, each portion of the drape 30 (e.g., the side sheet portion 36, the bowl portion 34, the windows 38, 40) is formed from a separate section or sheet of material, e.g., each having a different polymer composition. Each portion of the drape 30 may be cut to a size suitable for incorporation into the resulting drape, e.g., such that the edges of the cut portions overlap adjacent portions to form a bond therebetween. Any suitable bonding technique can be used to join the different portions of the drape 30 together to form the resulting drape structure. For example, the different portions of the drape 30 may be bonded together using adhesives and / or thermal bonding, e.g., ultrasonic bonding, RF bonding, laser bonding, or other bonding techniques that use heat to melt and bond overlapping sections of polymer material together and form a bond therebetween.

[0062] In general, the specific dimensions of drape 30 and each of its portions may vary depending on the configuration of the appliance intended to be covered by the drape. Bowl portion 34 of drape 30 may define a height 66 that varies depending on whether the bowl is in a fully extended (deployed, in-use) or fully collapsed (packaged) configuration (FIG. 7). In some examples, when the bowl is fully expanded, height 66 of bowl portion 34 ranges from 75 mm to 150 mm. In contrast, when bowl portion 34 is fully collapsed, the height of the bowl portion may be less than 50 mm, such as less than 25 mm.

[0063] To collapse the bowl portion 34, the bottom wall 42 and the side walls 44 may be folded into the void space defined by the bowl portion in an otherwise expanded state, as indicated by arrow 68 in FIG. 7 . For example, the bottom wall 42 of the bowl portion 34 may be pushed upward and / or the side sheet portions 36 may be pushed downward relative to the bowl portion until the bottom wall is substantially flush with the side sheet portions 36. In the process of moving the bottom wall 42 so that it is substantially flush with the side sheet portions 36, the side walls 44 may likewise be folded inward so that it is substantially flush with the bottom wall and the side sheet portions. As a result, the recess defined by the bowl portion 34 in the expanded state may be eliminated to provide a drape that is substantially flat or planar. This may facilitate further folding and / or packaging of the drape to provide a compact structure for storage.

[0064] 8 is a perspective view of drape 30 shown with bowl portion 34 folded to provide a planar flexible sheet. Depending on factors such as the thickness of the material(s) used to form drape 30 and the configuration of bowl portion 34, drape 30 may define a height 70 of less than 25 mm when bowl portion 34 is folded, such as less than 10 mm, less than 5 mm, or less than 1 mm. In some examples, when bowl portion 34 is folded, height 70 ranges from 1 mm to 50 mm, such as 5 mm to 25 mm. Height 70 can be measured when bowl portion 34 is folded and side sheet portions 36 are unfolded (as opposed to, e.g., stacked on top of the folded bowl portion).

[0065] The drape 30 may include various features to enhance the performance and / or functionality of the drape. As an example, the drape 30 may include an electronically readable tag embedded in the drape. For example, the electronically readable tag may be located within a pocket formed by bonding two sheets of material together. The electronically readable tag may be located within any portion(s) of the drape 30 to properly align the tag with the location of a corresponding contactless electronic tag reader associated with the equipment covered by the drape 30, for example.

[0066] 9 is a perspective view of an exemplary portion of a drape 30 illustrating how an electronically readable tag 80 may be positioned on the drape portion. In the example shown, the tag 80 is positioned within the first window portion 38 of the drape 30, although the tag may be positioned in other locations and / or other portions of the drape without departing from this disclosure.

[0067] To securely position the electronically readable tag 80 on the drape 30, the electronically readable tag 80 may be bonded between multiple layers. In the example of FIG. 9 , for example, the electronically readable tag 80 is shown disposed between a first layer of material 82 and a second layer of material 84. Each layer of material 82, 84 may itself be a single layer of material, or may be multiple layers of material bonded together, such as by coextrusion, to form a composite layer having an inner and outer surface. In either case, the first layer of material 82 and the second layer of material 84 may be bonded to one another, for example, using any of the bonding techniques described above, to seal the electronically readable tag 80 in the space between the layers of material. The layers of material may be sealed and / or bonded together directly to the periphery of the electronically readable tag 80, or may be bonded together to form a pocket surrounding and spaced apart from the periphery of the electronically readable tag 80.

[0068] In some examples, a small slit 86 (e.g., having a length shorter than the length of electronically readable tag 80) is formed through one of the material layers on which electronically readable tag 80 is disposed. Slit 86 may be useful during subsequent sterilization of drape 80, for example, by allowing a chemical sterilizing gas, such as ethylene oxide, to flow into the space between material layers 82, 84 for sterilization.

[0069] Electronically readable tag 80 may be any type of non-transitory electronically readable medium and may be readable using a contactless reader. In different examples, electronically readable tag 80 may be implemented using a barcode, a radio frequency identification (RFID) tag, or a near field communication (NFC) tag. Electronically readable tag 80 may or may not be covered with a manufacturer's or distributor's logo or trademark, such as by placing a branded sticker over electronically readable tag 80.

[0070] As described above, the drape 30 may be sterilized to provide a sterile cover over the equipment to be covered for a medical procedure. The drape 30 may be sterilized after manufacture and, optionally, after packaging. To ensure that the drape 30 is not inadvertently contaminated by an operator during the process of removing the drape from its packaging and deploying it over the equipment to be covered, the drape 30 may be packaged to facilitate sterilization and aseptic removal and deployment of the drape. For example, the drape 30 may be folded and packaged to allow a user to remove the drape from its packaging and apply it over the equipment to be covered while minimizing or eliminating contact with the sterile, outward-facing surface of the drape that defines the sterile field.

[0071] Figures 8 and 10-26 illustrate exemplary folding and packaging steps that can be used to produce a folded drape that facilitates subsequent sterile removal and unfolding. With reference to Figure 8, the drape 30 is shown as being arranged in a substantially planar or flat layout, which can be achieved by lining the drape up on a folding surface. The bowl portion 34 is folded to be substantially planar with the side sheet portion 36. As shown, the drape 30 defines a first perimeter 100 and a second perimeter 102 opposite the first perimeter of the drape. In Figure 8, the first perimeter 100 and the second perimeter 102 are longitudinal edges of a generally rectangular drape perimeter. However, in other examples, the perimeters used for folding can be lateral edges of a rectangular drape, edges opposite a circular drape perimeter, or other edges that define the outward extent of the drape to be folded.

[0072] In the folding technique shown in FIG. 8 , a first edge 100 of the drape 30 is folded toward a second edge 102 of the drape to form a first fold line 104. The first fold line 104 may extend parallel to the bowl portion 34. In some examples, the first fold line 104 is offset from the bowl portion 34 in a direction away from the second edge 102. Additionally or alternatively, the first fold line 104 can transverse (e.g., across) the bowl portion 34. The first fold line may bisect the bowl portion 34 or, in the example shown, may be offset from a centerline bisecting through the bowl portion 34 such that the first edge 100 is not folded all the way to the second edge 102.

[0073] Referring to FIG. 10 , a first edge 100 of the drape 30 can be folded back from a second edge 102, for example, in a direction opposite to the direction in which the first edge was initially folded toward the second edge. The first edge 100 may be folded back from the second edge 102 a distance less than the distance the first edge 100 was previously folded toward the second edge 102. As a result, this can establish a second fold line 106 that is offset from the first fold line 104. The distance between the first fold line 104 and the second fold line 106 and / or the drape material can define a first drape panel 108, which can be a folded section of drape material. Depending on the location of the first fold line 104 relative to the bowl portion 36, the first drape panel 108 can be at least partially, and in some instances completely, positioned over the folded bowl portion 36.

[0074] Continuing with reference to FIG. 11 , the first edge 100 of the drape 30 may be folded again toward the second edge 102 of the drape. The first edge 100 may be folded toward the second edge 102 a distance less than the distance the first edge 100 previously folded toward the second edge 102, so as to define a third fold line 110 that is offset from the second fold line 106. The distance between the second fold line 106 and the third fold line 110 and / or the drape material may define a second drape panel 112, which may be a second section of the folded drape material. Again, depending on the locations of the second fold line 106 and the third fold line 110, the second drape panel 112 may or may not be at least partially, and in some instances completely, positioned over the collapsible bowl portion 36. In different configurations, the first panel 108 may have the same width as the second panel 112 or may have a different width.

[0075] The process of folding the first edge 100 of the drape 30 toward the second edge 102 and back from the second edge to define additional fold lines and corresponding panels of material folded between the fold lines can be repeated one or more (e.g., multiple) times. The number of folds and folded panels created during the folding process can vary based on, for example, the size of the drape and the size of each panel created during the folding process. Figures 12-16 show additional exemplary folding steps that can be performed on the drape 30 to define additional fold lines 114 and additional folded panels 116 between adjacent fold lines.

[0076] Once the drape 30 has been folded an appropriate number of times, the free edge of the drape (e.g., first peripheral edge 100) can be positioned to be grasped by a user during subsequent unfolding of the drape. In some examples, such as the example shown in FIG. 17 , the first edge 100 is folded toward the second edge 102 to define a final fold line 118, positioning the first edge 100 above the collapsible bowl portion 36. For example, the first edge 100 may be folded toward the second edge 102 such that the edges are positioned on an axis that bisects the bowl portion 36.

[0077] FIG. 18 is a side view of a drape 30 showing exemplary configurations of fold lines and drape panel portions that may be formed through the drape folding process. The resulting folded drape section may have multiple drape panels stacked vertically on top of each other to define a stacked folded configuration. In some examples, the cumulative number of drape panels in the vertical stack may range from 2 to 20 panels, such as 5 to 15 drape panels. The drape panels may or may not be positioned above the folded bowl portion 36. The size of each panel may vary; in some examples, each panel ranges from 25 mm to 200 mm, such as 50 mm to 100 mm.

[0078] The illustrated example drape 30 is shown symmetrically, with the side sheet portions 34 extending from the bowl portion 36 to the first edge 100 the same distance as the side sheet portions extend from the bowl portion 36 to the second edge 102. Thus, the folding process shown and described with respect to FIGS. 8 and 10-18 for the half of the side sheet portion between the bowl portion 36 and the first edge 100 can be repeated for the second half of the side sheet portion 34 simultaneously with, before, or after folding the first half of the side sheet portion. In other configurations of the drape 30, the side sheet portions 34 may extend from only one side of the bowl portion 36, or may extend a different distance from the bowl portion to the first edge 100 than the second edge 102. Thus, the number of folds formed during folding and / or the size of the drape panels may be the same on each side of the bowl portion 36, or may be different on different sides of the bowl portion.

[0079] 19 is a side view of a drape 30 showing an exemplary configuration of fold lines and drape panel portions that can be formed through the process of folding both sides of the drape. As shown, both sides of the drape 30 are folded to define two vertically stacked sections of panel portions positioned next to each other. The first stack of panel sections includes a first fold line 104, a second fold line 106, a third fold line 110, etc., forming a first drape panel 108, a second drape panel 112, etc. The second stack of panel sections includes a fourth fold line 120, a fifth fold line 122, a sixth fold line 124, etc., forming a third drape panel 126, a fourth drape panel 128, etc.

[0080] In some examples, the first edge 100 of the drape 30 and the second edge 102 of the drape are folded toward each other to form the outermost fold of the complete drape. For example, the first edge 100 of the drape 30 and the second edge 102 of the drape may be adjacently aligned, and in some examples, may be in abutting contact. The edges may be substantially centered over the folded bowl portion 34, for example, aligned with an axis that bisects the bowl portion. In some configurations, tags, labels, or tabs are secured to the first edge 100 and / or the second edge 102. Respective labels may be aligned colinearly when the two edges are adjacently aligned and may provide a gripping surface and / or marker intended for a user to grasp when opening the drape 30. Each label can be positioned so that the user's hand is positioned on the innermost surface of the drape when grasping the label, which can help minimize the risk of the user touching a non-sterile instrument when opening the drape.

[0081] In some examples, the drape 30 may be folded further beyond the vertically stacked configuration shown in FIG. 19 . For example, FIGS. 20-22 illustrate additional exemplary folds that can be applied to the drape 30 to provide a compact, folded drape structure. As shown in the exemplary configuration of FIG. 20 , for example, opposing folded edges of the drape 30 may be folded toward each other to reduce the overall size profile of the folded drape. For example, the drape 30 may include a third perimeter 130 that is substantially perpendicular to the first edge 100 and the second edge 102. The drape may also include a fourth perimeter 132 opposite the third edge 130 of the drape. The drape 30 may be folded by folding a corner 134 formed by the intersection of the third edge 130 and the first fold line 104 toward the second edge 102 and / or the fourth fold line 120. It should be understood that the designation of particular fold line numbers is used for purposes of discussion, and the fold lines need not be in any particular numerical sequence or represent any particular number of folds imparted to the drape. The drape 30 can also be folded by folding the corner 136 formed by the intersection of the fourth edge 132 and the first fold line 104 toward the second edge 102 and / or the fourth fold line 120.

[0082] As shown in FIG. 21 , corner 138 formed by the intersection of third edge 130 and fourth fold line 120 may overlap corner 134 and be folded toward first edge 100 and / or first fold line 104. Additionally, corner 140 formed by the intersection of fourth edge 132 and fourth fold line 120 may overlap corner 136 and be folded toward first edge 100 and / or first fold line 104. As shown in FIG. 22 , the overlapping area of ​​corners 138 and 140 that extends beyond the folded body of drape 30 may be tucked back under the folded body. The ends of the resulting folded body may be folded, for example, perpendicular to bowl portion 36, to define the resulting folded drape as shown in FIGS. 23 and 24 .

[0083] After folding, the folded drape can be inserted into a container 150, as shown in Figure 25. The drape 30 and / or container 150 can then be subjected to a sterilization process to sterilize the drape 30 and / or the contents of the container 150. The container 150 can be sealed (e.g., airtight) to enclose the drape 30 within the container before or after sterilization. In some examples, the container 150 is formed of a polymeric material.

[0084] During use, an operator can open the container 150 and remove the drape 30 from the container. The operator can unfold the folded ends of the drape, e.g., by reversing the folding process described above. Before fully unfolding the drape, the operator can place the drape 30, more specifically the bowl portion 36 of the drape, over the corresponding bowl of the appliance to be covered. For example, before the operator unfolds the vertically stacked folds imparted to the drape 30, the operator can place the bowl portion of the drape into or over the bowl of the appliance to be covered. The operator can grasp the first edge 100 and the second edge 102, e.g., by grasping the respective tabs or labels located on each edge. The operator then pulls the edges outward and away from each other to unfold the vertically folded drape sections, e.g., as shown in FIG. 26 . In some instances, the operator can push the folded bowl portion 36 downward into the bowl of the covered instrument, thereby expanding the folded bowl portion of the drape and conforming the bowl portion to the walls of the bowl of the covered instrument. In either case, folding the drape 30 allows the operator to unfold the drape while minimizing contact with the outward-facing surface of the drape during unfolding, thereby reducing the likelihood that the sterile surface of the drape may become contaminated during unfolding.

[0085] Various embodiments are described. These and other embodiments are within the scope of the following claims. Items [1] to

[60] below list exemplary embodiments of the present invention. [1] 1. A drape for a surgical fluid heat treatment system, comprising: a flexible sheet having a bowl portion and a side sheet portion connected to the bowl portion; The bowl portion defines a bottom wall and a foldable sidewall, the foldable sidewall configured to transform from a first configuration in which the bowl portion is expanded so that the bowl portion is configured to fit into a bowl of the surgical fluid heat treatment system, to a second configuration in which the bowl portion is folded and the flexible sheet is planar. [2] Item 10. The drape of item 1, wherein the bowl portion is shape-indexed relative to the bowl of the surgical fluid heat treatment system. [3] 3. The drape of claim 1 or 2, wherein the foldable sidewalls extend upwardly and outwardly from the bottom wall of the bowl portion such that, when in the first configuration, the bowl portion defines an open top surface of a cross-sectional area greater than a cross-sectional area of ​​the bottom wall. [4] 4. The drape of any one of items 1 to 3, wherein when in the first configuration, the bottom wall is flat and the foldable side walls extending upwardly and outwardly from the bottom wall are curved. [5] 5. The drape of any one of items 1 to 4, wherein the foldable sidewalls further define a curved peripheral lip when in the first configuration. [6] 6. The drape of any one of items 1 to 5, wherein the foldable sidewall, when in the first configuration, extends upward from the bottom wall of the bowl portion to an inflection point and further extends downward from the inflection point. [7] 7. The drape of any one of items 1 to 6, wherein the collapsible sidewalls are configured to telescopically fold from the first configuration to the second configuration. [8] 8. The drape according to any one of items 1 to 7, wherein the bottom wall is flexible and deformable. [9] 9. The drape of any one of items 1 to 8, wherein the bowl portion defines an arcuate shape without a 90° angle.

[10] 10. The drape of any one of items 1 to 9, wherein when in the first configuration, the bowl portion defines a height in the range of 75 mm to 150 mm, and when in the second configuration, the flexible sheet defines a height in the range of 10 mm to 50 mm.

[11] 11. The drape of any one of items 1-10, wherein the bowl portion defines a periphery and the side sheet portions extend around the entire periphery of the bowl portion.

[12] Item 12. The drape of item 11, wherein the side sheet portions extend at least 35 centimeters from the periphery of the bowl portion around the entire periphery of the bowl portion.

[13] 13. The drape of any one of items 1 to 12, wherein the flexible sheet further includes at least one window portion disposed between and connected to the bowl portion and the side sheet portion.

[14] Item 14. The drape of item 13, wherein the bowl portion defines a perimeter having a length and a width, and the at least one window portion projects away from a longitudinal perimeter section of the bowl portion.

[15] Item 15. The drape of item 14, wherein the at least one window portion includes a first window portion and a second window portion, the first window portion projecting away from one longitudinal perimeter section of the bowl portion and the second window portion projecting away from an opposite longitudinal perimeter section of the bowl portion.

[16] 16. The drape of any one of items 1 to 15, wherein the bowl portion and the side sheet portions are opaque and the at least one window portion is transparent.

[17] 17. The drape of any one of items 1 to 16, further comprising an electronically readable tag.

[18] Item 18. The drape of item 17, wherein the electronically readable tag is sandwiched between at least two sheets of material that are joined together to define the flexible sheet.

[19] the electronically readable tag is a near field communication tag; the flexible sheet further includes at least one window portion disposed between and connected to the bowl portion and the side sheet portion; Item 18. The drape of item 17, wherein the near field communication tag is sandwiched between at least two sheets of material bonded together to define the window portion of the flexible sheet.

[20] When in the first configuration, the bowl portion defines an oval recess that transitions to a generally rectangular shape around the periphery of the bowl portion; the flexible sheet further includes a first window portion connected to one longitudinal side of the bowl portion and a second window portion connected to an opposite longitudinal side of the bowl portion; Item 18. The drape of item 17, wherein the side sheet portions are connected around the entire periphery defined by the bowl portion and the first and second window portions. [twenty one] a thermoformed bowl that is shape-indexed to the shape of a bowl of a surgical system into which the thermoformed bowl is configured to be inserted, the thermoformed bowl being foldable; and a flexible side sheet joined to and extending around the entire periphery of the thermoformed bowl. [twenty two] 22. The drape of item 21, wherein the thermoformed bowl is foldable from a height of more than 75 mm when expanded for use to a height of less than 25 mm when folded for packaging. [twenty three] Item 23. The drape of item 21 or 22, wherein the thermoformed bowl defines a bottom wall and a sidewall extending upwardly and outwardly from the bottom wall of the thermoformed bowl such that the thermoformed bowl defines an open top surface of a cross-sectional area greater than the cross-sectional area of ​​the bottom wall. [twenty four] 24. The drape of any one of items 21-23, wherein the flexible side sheets extend at least 35 centimeters from the periphery of the thermoformed bowl around the entire periphery of the thermoformed bowl. [twenty five] 25. The drape of any one of items 21-24, wherein the thermoformed bowl is formed of a polymer having a melt temperature greater than 130 degrees Fahrenheit.

[26] 26. The drape of any one of items 21 to 25, further comprising at least one flexible window sheet disposed between and connected to the thermoformed bowl and the flexible side sheets.

[27] Item 27. The drape of item 26, wherein the at least one flexible window sheet is thermally bonded to both the thermoformed bowl and the flexible side sheets.

[28] the thermoformed bowl defines a perimeter having a length and a width; the at least one flexible window includes a first flexible window and a second flexible window; the first flexible window projects away from and is thermally coupled to one longitudinal perimeter section of the thermoformed bowl; the second flexible window projects away from and is thermally coupled to an opposing longitudinal perimeter section of the thermoformed bowl; 28. The drape of either item 26 or 27, wherein the flexible side sheets are thermally bonded to the thermoformed bowl, the first flexible window, and the second flexible window around a perimeter collectively defined by the thermoformed bowl, the first flexible window, and the second flexible window.

[29] the thermoformed bowl is made from a first polymer composition; the at least one flexible window sheet is made from a second polymer composition different from the first polymer composition; 29. The drape of any one of items 26 to 28, wherein the flexible side sheets are made from a third polymer composition different from the first polymer composition and the second polymer composition.

[30] 30. The drape of item 29, wherein the first polymer composition, the second polymer composition, and the third polymer composition each comprise polyurethane.

[31] 31. The drape of either of items 29 or 30, wherein the second polymer composition comprises a tackifier and the at least one flexible window sheet exhibits a coefficient of friction greater than 1 according to ASTM D1894.

[32] Item 32. The drape according to any one of items 21 to 31, wherein the thermoformed bowl has a thickness greater than the thickness of the flexible side sheets.

[33] the thermoformed bowl defines a bottom wall and a side wall extending upwardly from the bottom wall of the thermoformed bowl, the flexible side sheets being bonded to a peripheral edge of the side wall; Item 33. The drape of any one of items 21 to 32, wherein the sidewalls define a thickness that increases from the periphery of the sidewalls toward the bottom wall.

[34] Item 34. The drape of item 33, wherein the thickness of the sidewalls varies from a minimum thickness of between 0.1 mm and 0.2 mm to a maximum thickness of 0.4 mm or more.

[35] Item 35. The drape according to item 33 or 34, wherein the maximum thickness is in the range of 0.4 mm to 0.7 mm.

[36] 36. The drape according to any one of items 21 to 35, wherein the flexible side sheets have a thickness in the range of 0.025 mm to 0.15 mm.

[37] 37. The drape of any one of items 21 to 36, further comprising an electronically readable tag, the electronically readable tag is a near field communication tag; A drape wherein the near field communication tag is sandwiched between at least two sheets of material joined together to define the at least one flexible window sheet.

[38] removing the folded flat drape from the sealed package; inserting a bowl portion of the drape into a bowl of a surgical fluid heat treatment system; and expanding the bowl portion of the drape from a collapsed configuration to an expanded configuration.

[39] Item 39. The method of item 38, wherein the bowl portion defines a bottom wall and a side wall, and expanding the bowl portion of the drape includes forcing the bottom wall of the bowl portion downward into the bowl portion, thereby expanding the side wall and conforming the bowl portion of the drape to the bowl of a surgical fluid heat treatment system.

[40] 40. The method of claim 38 or 39, wherein the expansion of the bowl portion occurs after the bowl portion of the drape is inserted into the bowl.

[41] 41. The method of any one of items 38-40, wherein the drape further includes a flexible side sheet coupled to and extending around the entire periphery of the bowl portion, and further comprising draping the flexible side sheet over an outer side of the bowl of the surgical fluid heat treatment system.

[42] 42. The method of any one of items 38-41, wherein the bowl portion defines a bottom wall and a sidewall extending upwardly and outwardly from the bottom wall of the bowl portion such that the bowl portion defines an open top surface of a cross-sectional area greater than a cross-sectional area of ​​the bottom wall.

[43] 43. The method of any one of items 38-42, wherein the drape further comprises at least one flexible window sheet disposed between and connected to the bowl portion and the flexible side sheet, and further comprising positioning the at least one flexible window sheet over a user interface of the surgical fluid heat treatment system.

[44] 44. The method of any one of claims 38-43, wherein the drape further comprises an electronically readable tag, and further comprising placing the electronically readable tag within readable proximity of a non-contact reader of the surgical fluid heat treatment system.

[45] Item 45. The method of item 44, wherein the electronically readable tag is a near field communications tag, and placing the electronically readable tag within readable proximity of the contactless reader includes placing the near field communications tag within 10 millimeters of the contactless reader.

[46] 46. ​​The method of any one of items 38 to 45, wherein the bowl portion is thermoformed.

[47] 47. The method of any one of items 38 to 46, wherein the drape defines a height in the range of 10 to 50 when folded flat within the sealed package and expands to a height in the range of 75 to 150 when expanded.

[48] 1. A method of folding a drape, comprising: providing a drape including a collapsible bowl and a flexible side sheet extending around a periphery of the collapsible bowl, the flexible side sheet having a first edge and a second edge on the flexible side sheet opposite the first edge; configuring the drape so that the collapsible bowl is folded into a substantially planar state; folding the first edge of the drape toward the second edge of the drape to form a first fold line across the collapsible bowl; folding the first edge of the drape back from the second edge of the drape to form a second fold line offset from the first fold line, thereby providing a first drape panel positioned over the collapsible bowl; and folding the first edge of the drape toward the second edge of the drape to form a third fold line offset from the second fold line, thereby providing a second drape panel positioned over the collapsible bowl.

[49] Item 49. The method of item 48, further comprising folding the first edge of the drape toward the second edge to position the first edge over the collapsible bowl.

[50] 50. The method of claim 48, further comprising folding the first edge of the drape toward the second edge of the drape and then folding back from the second edge of the drape a plurality of times to form a plurality of additional drape panels disposed over the collapsible bowl.

[51] Item 51. The method of item 50, wherein folding the first edge of the drape toward the second edge of the drape and then folding back from the second edge of the drape a plurality of times comprises folding the first edge of the drape toward the second edge of the drape and then folding back from the second edge of the drape a sufficient number of times to provide between 5 and 15 drape panels stacked vertically on top of each other above the collapsible bowl.

[52] 52. The method according to any one of items 48 to 51, wherein the first drape panel and the second drape panel are each in the range of 50 mm to 100 mm.

[53] folding the second edge of the drape toward the first edge of the drape to form a fourth fold line across the collapsible bowl; folding the second edge of the drape back from the first edge of the drape to form a fifth fold line offset from the first fourth line, thereby providing a third drape panel positioned over the collapsible bowl; 53. The method of any one of items 48-52, further comprising: folding the second edge of the drape toward the first edge of the drape to form a sixth fold line offset from the fifth fold line, thereby providing a fourth drape panel positioned over the collapsible bowl.

[54] Item 54. The method of item 53, further comprising folding the second edge of the drape toward the first edge to position the second edge over the collapsible bowl.

[55] Item 55. The method of item 54, further comprising folding the first edge of the drape toward the second edge and positioning the first edge abutting the second edge, wherein both the first edge and the second edge are located substantially in the center of the collapsible bowl.

[56] Item 54. The method of item 53, further comprising folding the second edge of the drape toward the first edge of the drape and then folding the drape back from the first edge multiple times to form multiple additional drape panels positioned over the collapsible bowl.

[57] Item 57. The method of item 56, wherein folding the second edge of the drape toward the first edge of the drape and then folding back from the first edge of the drape a plurality of times comprises folding the second edge of the drape toward the first edge of the drape and then folding back from the first edge of the drape a sufficient number of times to provide between 5 and 15 drape panels stacked vertically on top of each other above the collapsible bowl.

[58] the flexible sheet has a third edge substantially perpendicular to the first and second edges, and a fourth edge of the flexible side sheet opposite the third edge; Item 58. The method of any one of items 48 to 57, further comprising folding a corner formed by an intersection of the third edge and the first fold line toward the second edge.

[59] 21. Use of the drape according to any one of items 1 to 20 to cover a surgical fluid heat treatment system.

[60] 38. Use of the drape according to any one of items 21 to 37 to cover a surgical fluid heat treatment system.

Claims

1. 1. A method of folding a drape, comprising: providing a drape including a collapsible bowl and flexible side sheets extending around an outer periphery of the collapsible bowl, the flexible side sheets having a first edge, a second edge on the flexible side sheet opposite the first edge, a third edge substantially perpendicular to the first and second edges, and a fourth edge of the flexible side sheet opposite the third edge; configuring the drape so that the collapsible bowl is folded into a substantially planar state; folding the first edge of the drape toward the second edge of the drape to form a first fold line across the collapsible bowl; folding the first edge of the drape back from the second edge of the drape to form a second fold line offset from the first fold line, thereby providing a first drape panel for placement over the collapsible bowl; folding the first edge of the drape toward the second edge of the drape to form a third fold line offset from the second fold line, thereby providing a second drape panel positioned over the collapsible bowl; folding a corner formed by the intersection of the third edge and the first fold line toward the second edge; and folding a corner formed by the intersection of the fourth edge and the first fold line toward the second edge.

2. 10. The method of claim 1, further comprising folding the first edge of the drape toward the second edge to position the first edge over the collapsible bowl.

3. 3. The method of claim 1 or 2, further comprising folding the first edge of the drape toward the second edge of the drape and then folding back from the second edge of the drape multiple times to form multiple additional drape panels positioned over the collapsible bowl.

4. 4. The method of claim 3, wherein folding the first edge of the drape toward the second edge of the drape and then folding back from the second edge of the drape a plurality of times comprises folding the first edge of the drape toward the second edge of the drape and then folding back from the second edge of the drape a sufficient number of times to provide between 5 and 15 drape panels stacked vertically on top of each other above the collapsible bowl.

5. The method of any one of claims 1 to 4, wherein the first drapery panel and the second drapery panel each range from 50mm to 100mm.

6. folding the second edge of the drape toward the first edge of the drape to form a fourth fold line across the collapsible bowl; folding the second edge of the drape back from the first edge of the drape to form a fifth fold line offset from the first fourth line, thereby providing a third drape panel positioned over the collapsible bowl; 6. The method of claim 1, further comprising: folding the second edge of the drape toward the first edge of the drape to form a sixth fold line offset from the fifth fold line, thereby providing a fourth drape panel positioned over the collapsible bowl.

7. 7. The method of claim 6, further comprising folding the second edge of the drape toward the first edge to position the second edge over the collapsible bowl.

8. 8. The method of claim 7, further comprising folding the first edge of the drape toward the second edge and positioning the first edge against the second edge, wherein both the first edge and the second edge are located substantially in the center of the collapsible bowl.

9. 7. The method of claim 6, further comprising folding the second edge of the drape toward the first edge of the drape and then folding the drape back from the first edge multiple times to form multiple additional drape panels positioned over the collapsible bowl.

10. 10. The method of claim 9, wherein folding the second edge of the drape toward the first edge of the drape and then folding back from the first edge of the drape a plurality of times comprises folding the second edge of the drape toward the first edge of the drape and then folding back from the first edge of the drape a sufficient number of times to provide between 5 and 15 drape panels stacked vertically on top of each other above the collapsible bowl.

11. removing a folded, flat drape from a sealed package, the drape including a collapsible bowl and flexible side sheets extending around the periphery of the collapsible bowl; inserting the bowl portion of the drape into a bowl of a surgical fluid heat treatment system; expanding the bowl portion and the flexible side sheets of the drape from a folded configuration to an expanded configuration, the flexible side sheet has a first edge, a second edge on the flexible side sheet opposite the first edge, a third edge substantially perpendicular to the first and second edges, and a fourth edge of the flexible side sheet opposite the third edge; In the folded configuration, the collapsible bowl is folded substantially flat; the first edge of the drape is folded toward the second edge of the drape to form a first fold line across the collapsible bowl; and the first edge of the drape is folded back from the second edge of the drape to form a second fold line offset from the first fold line, thereby providing a first drape panel disposed over the collapsible bowl; the drape is positioned such that: the first edge is folded toward the second edge of the drape to form a third fold line offset from the second fold line, thereby providing a second drape panel for placement over the collapsible bowl; a corner formed by the intersection of the third edge and the first fold line is folded toward the second edge; and a corner formed by the intersection of the fourth edge and the first fold line is folded toward the second edge.

12. 12. The method of claim 11, wherein the bowl portion defines a bottom wall and a side wall, and expanding the bowl portion of the drape includes forcing the bottom wall of the bowl portion downward into the bowl portion, thereby expanding the side wall and conforming the bowl portion of the drape to the bowl of a surgical fluid heat treatment system.

13. 13. The method of claim 11 or 12, wherein the drape further comprises at least one flexible window sheet disposed between and connected to the bowl portion and the flexible side sheets, and further comprising positioning the at least one flexible window sheet over a user interface of the surgical fluid heat treatment system.

14. 14. The method of claim 11, wherein the drape further comprises an electronically readable tag, and further comprising placing the electronically readable tag within readable proximity of a non-contact reader of the surgical fluid heat treatment system.

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