Surgical Drapes for Robotic Devices

Abstract

To provide a surgical drape for covering a surgical robot device capable of assembling a distal expansion part.SOLUTION: Provided is a drape including I. a first drape portion and II. a second drape portion. The first drape portion is formed of a thin sheet of a flexible material defining an elongated hollow sleeve, and includes an opening end located in a first side of the sleeve, a partial closing end located in a facing second side of the sleeve, a body being an elongated sleeve extending between the opening end and the partial closing end, and an accessible opening part extending from the partial closing end to a portion adjacent to the body of the sleeve. The second drape portion is configured so as to be arranged on the first drape portion, is formed of a thin sheet of a flexible material, and has shape and size at least partially covering the accessible opening part.SELECTED DRAWING: Figure 3

Description

[Background technology]

[0001] [Related Applications] This application claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62 / 786,452, filed December 30, 2018, the contents of which are incorporated herein by reference in their entirety.

[0002] [Field and Background of the Invention] In some embodiments thereof, the present invention relates to a surgical drape for covering a surgical device, and more particularly, but not exclusively, to a surgical drape for covering a surgical robotic device that can have a distal extension assembled thereto.

[0003] Patent Document 1 discloses a "surgical radiology C-arm imaging unit drape configured to provide a sterile outer surface for the end of a C-arm imaging unit and a method for providing a sterile surface for the end of a C-arm imaging unit." The drape includes a flexible housing having an upper wall with a pair of side walls and a rear surface extending downward from the upper wall. The upper and side walls are expandable between an extended position and a folded position. In the extended position, a pocket sized to receive the end of the imaging unit is formed under the upper wall. The upper wall has a sterile outer surface configured to overlap the end of the imaging unit, facing away from it, to maintain sterility in a sterile zone above the operating table. When in the folded position, the sterile outer surface is sealed off from external contamination (abstract). [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent No. 8,286,637 Summary of the Invention [Means for solving the problem]

[0005] According to an aspect of some embodiments of the present invention, there is provided a two-part drape for a surgical device, the drape comprising: (i) a first drape part formed from a thin sheet of flexible material defining an elongated hollow sleeve, the first drape part including an open end on a first side of the sleeve, a partially closed end on an opposing second side of the sleeve, an elongated sleeve body extending between the open end and the partially closed end, and an accessible opening extending from the partially closed end to an adjacent portion of the sleeve body; and (ii) a second drape part configured to be disposed over the first drape part, the second drape part formed from a thin sheet of flexible material, the second drape part shaped and sized to at least partially cover the accessible opening. In some embodiments, the body of the first drape part includes at least one fixation element embedded or attached thereto and positioned between the accessible opening and the open end. In some embodiments, the fixation element comprises an elongated deformable element. In some embodiments, the body of the first drape portion is closed along a long side of the body. In some embodiments, the accessible opening is rectangular. In some embodiments, the second drape portion comprises handling portions each including a valley fold sized for inserting at least a portion of a user's hand. In some embodiments, the drape is formed of a continuous or welded plastic or nylon sheet. In some embodiments, the drape is formed of one or more of thermoplastic polyurethane, ultra-high molecular weight polyethylene, low-density polyethylene, and high-density polyethylene. In some embodiments, the drape is at least partially transparent to allow visualization of at least a portion of a surgical device covered by the drape. In some embodiments, the first drape portion comprises a marker extending around at least the periphery of the accessible opening. In some embodiments, the marker comprises a colored backing.In some embodiments, the first drape portion includes a pocket or fold into which the second drape portion can be placed and pulled away or inserted. In some embodiments, the first and second drape portions are formed as a unit. In some embodiments, the first and second drape portions are formed as separate sheets. In some embodiments, one or both of the first and second drape portions include attachment means including one or more of an adhesive, hook-and-loop fastener, Velcro®, or a magnet. In some embodiments, one or both of the first and second drape portions include one or more markings to indicate the orientation of the drape portion over the surgical device. In some embodiments, the drape is formed of a material suitable for sterilization.

[0006] According to some embodiments of the present invention, an assembly is provided that includes a surgical device including a motor unit configured to attach to one or more surgical arms and a drape, the drape being placed over the motor unit. In some embodiments, an accessible opening in a first drape portion exposes an access port of the motor unit to which the one or more surgical arms are attached. In some embodiments, the first drape portion includes a fixation element attached to or embedded in the first drape portion, the fixation element being positioned to fit over an edge of the motor unit. In some embodiments, the accessible opening exposes at least a portion of the top surface of the motor unit and at least a portion of the front (distal) surface of the motor unit where the exit aperture of the one or more surgical arms is located.

[0007] According to an aspect of some embodiments of the present invention, there is provided a surgical device drape comprising: a sleeve formed from a thin sheet of flexible material defining an open end, a partially closed end opposite the open end, and a tubular body extending between the open end and the partially closed end, the sleeve including a notch extending from an edge of the partially closed end to a side edge of the body perpendicular to the edge of the partially closed end when the sleeve is laid flat. In some embodiments, the notch has a stepped profile. In some embodiments, the drape further comprises a fastening element disposed along at least a portion of the side edge of the body between the notch and the open end.

[0008] According to some embodiments, an assembly is provided that includes a drape and a surgical device onto which the drape is deployed, wherein a cutout in the drape exposes an access port of the surgical device to which a device extension can be attached. In some embodiments, a fixation element is mounted over an edge of the surgical device. In some embodiments, the surgical device includes a motor unit for actuating one or more surgical arms, and the device extension includes one or more surgical arms.

[0009] According to an aspect of some embodiments of the present invention, there is provided a method of assembling a surgical device while minimizing exposure of the surgical device to the environment, the method comprising: unfolding a drape to cover the surgical device; removing a first portion of the drape, the first portion covering an access port and exit aperture of the surgical device from which at least one surgical arm extends; replacing at least one surgical arm during a surgical procedure while maintaining at least 90% of the surface area of ​​the surgical device covered by the drape; and covering the access port with a second drape portion.

[0010] According to an aspect of some embodiments of the present invention, there is provided a method of sterilely covering a surgical device having an access port at a distal portion for attachment to a distal device extension, the method comprising: unfolding a surgical drape from a compressed state; unfolding the drape over the surgical device to cover the surgical device; aligning an opening formed in the distal portion of the drape with the access port; and maintaining the alignment by attaching a fixation element embedded in or attached to the drape opposite the opening so that the fixation element conforms to the shape of the proximal portion of the surgical device. In some embodiments, the opening and the fixation element are disposed along a longitudinal axis of the drape, and the aligning step comprises aligning at least a portion of the longitudinal axis of the drape along which the opening and the fixation element are disposed with the longitudinal axis of the surgical device. In some embodiments, the method comprises attaching the distal device extension through the access port and covering the access port with a second drape or drape portion so that only the distal device extension protrudes therefrom. In some embodiments, the method includes replacing the distal extension during the surgical procedure by moving a second drape or drape portion away from the access port, replacing the distal extension, and re-covering the access port with the second drape or drape portion.

[0011] According to an aspect of some embodiments of the present invention, there is provided a method of sterilely covering a surgical device including an access port, the method comprising: unfolding a drape including an opening to cover the surgical device while exposing the access port through the opening; applying the drape to the surgical device so that the opening is maintained in alignment with the access port; and providing consistent access to the access port. In some embodiments, the applying comprises attaching a fixation element embedded in or attached to the drape to the surgical device. In some embodiments, the fixation element comprises a deformable, semi-rigid, elongated strip, and the applying comprises bending the strip over an edge of the surgical device. In some embodiments, the drape comprises a removable or movable portion covering the opening, and the method comprises removing or moving the removable or movable drape portion to expose the access port. In some embodiments, the removing comprises tearing the drape portion, and the moving comprises one or both of folding and rolling the drape portion to expose the access port. In some embodiments, the removing or moving step occurs within 2 minutes prior to attaching the device extension to the surgical device through the access port.

[0012] According to an aspect of some embodiments of the present invention, there is provided an assembly comprising: a motor unit for actuating a surgical arm, the motor unit including an access port for assembling the surgical arm; and a surgical drape including a drape body including an opening that aligns with the access port when the drape is deployed over the motor unit, and a portion shaped and sized to substantially cover the access port after assembly of the surgical arm while allowing the assembled surgical arm to protrude outward from the motor unit.

[0013] According to an aspect of some embodiments of the present invention, there is provided a surgical drape for covering a surgical device including an access port for assembly of a distal extension, the surgical drape comprising: a thin sheet of flexible material, a distal portion of the sheet having an opening shaped and sized to expose the access port; and at least one fixation element (e.g., a deformable strip) embedded in or attached to a proximal portion of the sheet, the fixation element and the opening being aligned along the longitudinal axis of the sheet such that the opening remains aligned with the access port when the fixation element is attached to the surgical device. In some embodiments, the opening and the fixation element are positioned opposite each other along the longitudinal axis of the sheet. In some embodiments, when the fixation element is attached to the device, the drape is aligned axially with respect to the length of the device. In some embodiments, when the fixation element is attached to the device, the opening is centered with respect to the width of the device. In some embodiments, the fixation element is sufficiently rigid to act as a frame for shaping at least a portion of the drape when deployed over the device. In some embodiments, the fixation elements are sufficiently rigid to fasten the drape over the device and secure the drape to the device to prevent movement. In some embodiments, the fixation elements are in the form of strips comprising coated flexible wire. In some embodiments, the drape is shaped to cover a box-shaped surgical device. In some embodiments, the drape, in its expanded state, comprises a rectangular cross-sectional profile including a cut-off corner that defines an opening.

[0014] According to an aspect of some embodiments of the present invention, there is provided a two-part surgical drape for covering a surgical device, the surgical drape comprising: a first drape part having an opening shaped, sized, and positioned to expose an access port of the surgical device to which a distal extension of the surgical device is assembled and an exit aperture through which the distal extension protrudes outward from the device; and a second drape part at least partially deployed over the first drape part after assembly of the extension, the second drape part having a shape and size to cover the exposed access port and define a cutout through which the device extension protrudes outward. In some embodiments, the second drape part comprises a handling portion including a valley fold sized for insertion of at least a portion of a user's hand, the valley fold extending adjacent to the exit aperture and defining the cutout when the drape is unfolded. In some embodiments, the drape includes a flexible band extending from the proximal surface of the second drape portion, the flexible band wrapping around and supporting the device extension at the exit aperture and having a length sufficient to surround the exit aperture. In some embodiments, when the first drape portion is deployed over the device, the opening extends from a distal portion of the upper surface of the drape to the top of the distal surface of the drape. In some embodiments, the drape is formed of a continuous or welded plastic or nylon sheet. In some embodiments, the drape is at least partially transparent to allow visibility of at least a portion of the device. In some embodiments, the drape includes a colored lining to indicate a sterile field. In some embodiments, the first drape portion includes a pocket or fold into which the second drape portion can be housed and pulled away or inserted. In some embodiments, the first and second drape portions are integrally attached. In some embodiments, the first and second drape portions are formed of separate sheets.

[0015] According to an aspect of some embodiments of the present invention, there is provided a surgical drape for covering a surgical device, the surgical drape comprising: a first sheet including an opening; a second sheet configured to fit over the first sheet, the second sheet covering the opening in the first sheet to reduce exposure of a portion of the device underlying the opening to the surroundings; one or more adhesives on one or both of the first and second sheets to connect the first and second sheets to each other; and one or more adhesives on the first sheet to connect the first sheet to the device. In some embodiments, the adhesives comprise one or more of a peel tab, a sticker, a hook-and-loop fastener, a double-lock fastener, and / or an adhesive having interlocking flat surfaces. In some embodiments, one or both of the first and second sheets include one or more markings to indicate the direction of deployment of the sheet onto the device. In some embodiments, each of the sheets is in a folded, compressed configuration. In some embodiments, the cross-sectional surface area of ​​each of the drape sheets in the compressed configuration is at least 10 times less than the cross-sectional surface area of ​​each of the unfolded sheets. In some embodiments, one or more of the bonds are disposed adjacent to the opening.

[0016] According to an aspect of some embodiments of the present invention, there is provided a method for assembling a robotic device while minimizing exposure of the device to an operating room environment, the method comprising: removing a drape portion covering an access port through which at least one robotic arm is received; exchanging the at least one robotic arm during surgery while maintaining at least 90% of the surface area of ​​the device covered with sterile drapes; and covering the access port with the drape portion.

[0017] According to one aspect of some embodiments of the present invention, there is provided a peel-off adhesive for a surgical drape, comprising: an adhesive strip; and an elongated release paper attached to the adhesive strip, the release paper having a first end configured on an inner side of the drape and a second end extending to an outer side of the drape, wherein pulling the second end causes the first end to peel from the adhesive strip, such that the adhesive strip adheres to a device covered by the drape without direct contact with the user.

[0018] According to an aspect of some embodiments of the present invention, there is provided a method of sterilely covering a surgical device including an access port, the method comprising: unfolding a surgical drape from a compressed state; unfolding the drape over the surgical device to cover the surgical device; aligning an opening formed in a distal portion of the drape with the access port; and maintaining the alignment by applying a fixation element (e.g., a plastically deformable strip) embedded in or attached to a proximal portion of the drape opposite the opening such that the fixation element conforms to the shape of the proximal portion of the surgical device. In some embodiments, the opening and the fixation element are disposed along a longitudinal axis of the drape, and the aligning step comprises aligning the longitudinal axis of the drape with a longitudinal axis of the surgical device. In some embodiments, the method further comprises attaching a distal device extension through the access port and covering the access port with a second drape or drape portion such that only the distal device extension protrudes therefrom. In some embodiments, the method further includes replacing the distal extension portion during surgery by moving the second drape or drape portion away from the access port, replacing the distal extension portion, and re-covering the access port with the second drape or drape portion.

[0019] According to an aspect of some embodiments of the present invention, there is provided a kit comprising: a motor unit for operating a robotic arm, the motor unit including an access port for assembling the robotic arm; and a surgical drape including: a first sheet including an opening that aligns with the access port when the first sheet is unfolded over the motor unit; and a second sheet including a portion shaped and sized to substantially cover the access port after assembly of the robotic arm.

[0020] According to an aspect of some embodiments of the present invention, there is provided a surgical drape for covering a surgical device, the surgical device including an access port at a distal end of the device for assembling a device extension portion, the drape comprising a thin sheet of flexible material, the sheet having a length sufficient to extend at least between the distal end of the device and the proximal end of the device, the sheet including an opening shaped and sized to expose the access port, and at least one fastener embedded within or attached to the sheet, the fastener positioned opposite the opening at a location corresponding to the proximal end of the device, the opening and fastener being positioned at a distance from each other corresponding to the distance between the access port and the proximal end of the device, such that when the fastener is attached to the surgical device, the opening is held and maintained in registration with the access port.

[0021] According to one aspect of some embodiments of the present invention, there is provided a surgical drape for covering a surgical device, the surgical drape comprising: a first sheet having an opening; a second sheet shaped to overlie the first sheet when the first sheet is unfolded to cover the surgical device, the second sheet covering the opening in the first sheet and thereby reducing exposure to the surroundings of a portion of the device underlying the opening; one or more adhesive portions provided on one or both of the outer surface of the first sheet and the inner surface of the second sheet to join the first and second sheets to each other; and one or more adhesive portions provided on the inner surface of the first sheet to join the first sheet to the device.

[0022] In accordance with an aspect of some embodiments of the present invention, there is provided a method of sterilely covering a surgical device including an access port, the method comprising the steps of: unfolding a surgical drape in a compressed state; unfolding the drape over the surgical device to cover the surgical device; aligning an opening formed in a distal portion of the drape with the access port; and maintaining the alignment by applying a fixation element embedded in or attached to a proximal portion of the drape opposite the opening such that the fixation element conforms to the shape of the proximal portion of the surgical device.

[0023] According to an aspect of some embodiments of the present invention, there is provided a peel adhesive for a surgical drape, comprising: an adhesive strip; and an elongated release paper attached to the adhesive strip, the elongated release paper having a first end configured on an interior side of the drape and a second end extending outside the drape, the second end configured to be pulled, thereby peeling the first end from the adhesive strip and causing the adhesive strip to adhere to a device covered by the drape without direct contact with a user.

[0024] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. Additionally, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting. [Brief explanation of the drawings]

[0025] Some embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings. Referring now in detail to the drawings, it will be stressed that the specific details shown are by way of example and are for the purpose of illustrating embodiments of the invention. In this regard, the description taken with the drawings will make apparent to those skilled in the art how embodiments of the invention may be practiced.

[0026] [Figure 1] FIG. 1 is a flowchart of a method for surgically draping a device including attachable extensions, according to some embodiments. [Figure 2] FIG. 2 schematically illustrates deployment of a drape including a deformable element (eg, a semi-rigid strip) and an opening for attachment to an access port of a surgical device, according to some embodiments. [Figure 3] FIG. 3 is a flowchart of a method for surgically draping a device including modular extensions, according to some embodiments. [Figure 4A] FIG. 4A shows a schematic of the top surface of a device including a distal extension when the device is covered with a sterile drape, according to some embodiments. [Figure 4B] FIG. 4B shows a schematic of the distal face of the device when the device, including the distal extension, is covered with a sterile drape, according to some embodiments. [Figure 5] FIG. 5 is a flowchart of a method for covering a surgical device with a sterile drape made of two separate sheets, according to some embodiments. [Figure 6] FIG. 6 is a flowchart of a method for exchanging distal device extensions mid-procedure while maintaining sterility of the device, according to some embodiments. [Figure 7A] FIG. 7A is a schematic illustration of a bottom drape sheet for covering a surgical device with distal extensions, according to some embodiments. [Figure 7B] FIG. 7B is a schematic illustration of a top drape sheet for covering a surgical device with distal extensions, according to some embodiments. [Figure 8] FIG. 8 is a schematic illustration of a drape adhesive in the form of a peel tab, according to some embodiments. [Figure 9] FIG. 9 illustrates a schematic of a surgical drape with folds, according to some embodiments. [Figure 10A] FIG. 10A is an image of a bottom drape sheet deployed over a motor unit of a surgical arm, according to some embodiments. [Figure 10B] FIG. 10B is an image of a bottom drape sheet deployed over a motor unit of a surgical arm, according to some embodiments. [Figure 11A] FIG. 11A is an image of a top drape sheet deployed over a motor unit of a surgical arm, according to some embodiments. [Figure 11B] FIG. 11B is an image of a top drape sheet deployed over a motor unit of a surgical arm, according to some embodiments. [Figure 12] FIG. 12 is an image of a deformable drape element in the form of a semi-rigid strip, according to some embodiments. [Figure 13A] FIG. 13A is an image of an extended bottom drape, according to some embodiments. [Figure 13B] FIG. 13B is an image of a folded bottom drape according to some embodiments. [Figure 13C] FIG. 13C is an image of a folded top drape according to some embodiments. [Figure 14A] FIG. 14A illustrates a schematic of a drape sheet with removable or movable portions, according to some embodiments. [Figure 14B] FIG. 14B illustrates a schematic of a drape sheet with removable or movable portions, according to some embodiments. [Figure 14C] FIG. 14C illustrates a schematic of a drape sheet with removable or movable portions, according to some embodiments. [Figure 14D]FIG. 14D illustrates a schematic of a drape sheet with removable or movable portions, according to some embodiments. [Figure 14E] FIG. 14E illustrates a schematic of a drape sheet with removable or movable portions, according to some embodiments. [Figure 15A] FIG. 15A is an image of a drape sheet with openings shaped and sized to expose the motor unit's access port and exit aperture, according to some embodiments. [Figure 15B] FIG. 15B is an image of a drape sheet with openings shaped and sized to expose the motor unit's access port and exit aperture, according to some embodiments. [Figure 15C] FIG. 15C is an image of a drape sheet with openings shaped and sized to expose the motor unit's access port and exit aperture, according to some embodiments. [Figure 16] FIG. 16 is a flowchart of a method of using a drape sheet that includes a removable or movable portion, according to some embodiments. [Figure 17A] FIG. 17A schematically illustrates a drape for covering a surgical device and at least a portion of a base to which the surgical device is attached, according to some embodiments. [Figure 17B] FIG. 17B schematically illustrates a drape for covering a surgical device and at least a portion of a base to which the surgical device is attached, according to some embodiments. [Figure 17C] FIG. 17C schematically illustrates a drape for covering a surgical device and at least a portion of a base to which the surgical device is attached, according to some embodiments. [Figure 17D] FIG. 17D schematically illustrates a drape for covering a surgical device and at least a portion of a base to which the surgical device is attached, according to some embodiments. [Figure 18]FIG. 18 is an image of a drape covering the motor unit while exposing the motor unit's access port and exit aperture, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0027] In some embodiments thereof, the present invention relates to a surgical drape for covering a surgical device, and more particularly, but not exclusively, to a surgical drape for covering a surgical robotic device that can have a distal extension assembled thereto.

[0028] A broad aspect of some embodiments of the present invention relates to maintaining the sterility of a surgical device including an access port for attaching a distal device extension. Some embodiments relate to limiting the exposure of the access port to maintain sterility. Some embodiments relate to placing a surgical drape over the device in a manner that allows for modification (e.g., removal, installation, or replacement) of the distal extension, such as by a robotic arm (e.g., a surgical robotic arm), even during surgery, by minimizing the exposure of areas of the device not covered by the drape. Some embodiments relate to minimizing the exposure of portions of the device not covered by the surgical drape to a sterile environment, such as an operating room.

[0029] An aspect of some embodiments of the present invention relates to a surgical drape including at least one fastener, e.g., a deformable or flexible element, arranged to align or maintain alignment of the drape with a device such that an opening defined in the drape is aligned with an access port of the device. In some embodiments, the fastener and opening are aligned, e.g., along the longitudinal axis of the drape. Optionally, the fastener and opening are located on axially opposite portions of the drape. In some embodiments, the opening is defined in a portion of the drape corresponding to the distal end of the surgical device, and the fastener is located in a portion of the drape corresponding to the proximal end of the surgical device. Optionally, the opening and fastener are aligned with each other and with the surgical device onto which the drape is deployed. In some embodiments, the distance between the opening and the fastener corresponds to the length of the surgical device. In the example of a drape for covering the motor units of one or more surgical arms, the opening of the drape is positioned to align with the access port to which the surgical arm is attached, and the fastener is positioned to be bent or otherwise attached over the proximal end of the motor unit, for example, bent over a corner or edge connecting the top surface of the motor unit to the back surface of the motor unit.

[0030] In some embodiments, the opening is shaped and / or sized according to the shape and / or size of the access port. According to one example, the opening is substantially rectangular. In some embodiments, the surface area of ​​the opening matches or optionally exceeds the surface area of ​​the access port. In some embodiments, the opening has a seam around its border, optionally matching the location of the border of the access port of the surgical device.

[0031] In some embodiments, the fixation element is deformable and / or flexible, allowing it to be worn or bent to conform to the shape of the surgical device or portion thereof, e.g., bent over a corner of the surgical device. Optionally, the fixation element is non-rigid or semi-rigid. Optionally, the fixation element is plastically deformable. In some embodiments, the fixation element secures the drape to the device and sets the opening to fully overlap the access port. In some embodiments, the drape covers the device, surrounding all parts of the device except the access port and, optionally, the exit aperture from which the distal extension protrudes outward. In some embodiments, the fixation element is formed of a material that is rigid enough to secure the drape over the device and hold the drape in place, yet flexible enough to be bent by a user's fingers. In one example, the stiffness of the fixation element ranges from 1 N / m to 10 N / m, e.g., 3 N / m, 5 N / m, 7 N / m, or intermediate, higher, or lower values.

[0032] In some embodiments, the fixation element tightens the drape over the device and stretches the opening across the access port. In some embodiments, the fixation element assists the user by indicating a desired position or orientation during deployment of the drape. In some embodiments, the fixation element is flexible enough to fold over a corner of the device and / or fit into or over a designated groove or marking formed on the device. In some embodiments, the fixation element functions as a frame to shape at least a portion of the drape when deployed over the device. In some embodiments, the fixation element secures the drape to the device in a manner that reduces or prevents drape movement while maintaining access to the access port through the opening in the drape.

[0033] Optionally, the fixation element is shaped, and in some embodiments, reshaped, during use. Optionally, the fixation element is attached to a designated device location. In some examples, the fixation element is optionally folded, stretched, twisted, and / or otherwise manipulated during use (e.g., during device sheathing) to conform to the shape of the device. The fixation element may be in the form of a rigid or semi-rigid strip, clip, string, magnet, hook-and-loop fastener (such as Velcro), and / or other element that can be bent to attach to the device. Optionally, the strip-like fixation element comprises a metal element, such as a metal wire, and in some embodiments, is coated with a plastic backing. Optionally, the fixation element is embedded within the draped sheet. Alternatively, the fixation element is attached to the sheet.

[0034] An aspect of some embodiments of the present invention relates to a surgical drape designed to provide for the attachment, removal, or replacement of device extensions while limiting the exposure of portions of the device not directly related to the assembly of the extensions, thereby reducing exposure of the device to the sterile surgical environment and protecting the device from contamination (e.g., from contaminating liquids).

[0035] One aspect of some embodiments relates to a drape that includes a first portion including an opening shaped and sized to overlap a device access port and a second portion including a cover that overlaps the opening, e.g., after loading of a device extension. In some embodiments, replacement or removal of a device extension (after initial loading of the extension) may be accomplished by removing, lifting, pushing aside, and / or otherwise moving the cover away from the opening in the drape to expose the access port.

[0036] In some embodiments, the drape comprises two separate sheets. Optionally, the first sheet includes the opening and the second sheet includes the cover. Alternatively, a single sheet drape is provided that includes a removable cover portion or an integral pocket or fold within which the cover can be contained, pulled out, and compressed.

[0037] In some embodiments, the drape includes a tear-away piece that can be removed or moved (e.g., folded or rolled) to form an opening in the drape. Optionally, in use, the drape is placed over the surgical device, and the tear-away piece is opened or removed to expose the access port only when or if a distal extension is to be attached through the access port. In some embodiments, the drape is manufactured and packaged with the tear-away piece attached as a unit to the rest of the sheet. In use, a user (e.g., a nurse, doctor, technician) removes or moves the tear-away piece, such as by pulling along the dashed line that borders the piece. In addition to or instead of the tear-away piece, a cover is provided that is shaped and / or sized to at least partially overlap the opening exposing the access port. During use, a user can remove, roll up, push aside, or otherwise move the cover to expose the access port. Potential advantages of exposing the access port only near or at the time of assembly of the distal extension to the surgical device may include reducing and optionally minimizing exposure of the device to the environment, potentially contributing to maintaining sterility.

[0038] Potential advantages of a removable or movable drape portion may include that the device portion covered by the drape portion, such as an access port, remains covered until the step of attaching a device extension (such as one or more surgical arms) through the access port.

[0039] In some embodiments, when the drape is unfolded, the distal surface of the drape is shaped to expose the exit aperture through which the distal device extension protrudes. In some embodiments, the drape is formed with opposing valley folds defining a cutout therebetween that exposes the exit aperture when unfolded. In some embodiments, the valley folds also function as handling portions, and upon unfolding, a user places their hand within the valley fold and pulls the drape over the device.

[0040] In some embodiments, the drape comprises a flexible band extending from the distal surface of the drape and having a length sufficient to wrap around the device extension at the exit aperture. In some embodiments, the flexible band helps support the device extension and hold it in place. In some embodiments, the flexible band covers any remaining exposed area around the exit aperture, thereby potentially reducing the risk of contamination.

[0041] Potential benefits of a surgical drape configured to provide limited exposure of the distal extension's access port and exit aperture may include maintaining sterility in the operating room environment even when the extension is modified (assembled, removed, or replaced). Optionally, at least 85%, 95%, 99%, or any intermediate, higher, or lower percentage of the device's exterior surface area remains covered by the drape at all times. Optionally, 15%, 20%, 5%, 30%, or any intermediate, higher, or lower percentage of the device's exterior surface is not covered by the drape. In some cases, the device itself (e.g., a motor unit that actuates one or more surgical arms) is not sterile and must be covered to maintain the sterility of the surrounding operating room environment. Optionally, the one or more surgical arms attached to the motor unit are sterile so that they can be used to operate on a patient. If the arms are not sterile, they may be covered with a protective sheath.

[0042] In some embodiments, the drape comprises one or more attachment means, such as stickers, peel tabs, hook-and-loop fasteners, dual-lock fasteners, fasteners including bonding surfaces, and / or other suitable means for attaching the drape to the device and / or attaching drape portions to one another. In some embodiments, the location of the one or more attachment means is selected to aid in positioning (e.g., aligning or orienting the drape relative to the device) during deployment. In some embodiments, the location of the one or more attachment means is selected in an area prone to contact with and / or penetration by contaminants. For example, one or more adhesives may be positioned around the perimeter of an opening formed in the drape to reduce the likelihood of contaminants penetrating between the drape and the device.

[0043] In some embodiments, the surgical drape is shaped and / or sized to at least partially cover the base to which the surgical device is attached. In one example, the drape is large enough to cover the motor unit and the mobile cart to which the motor unit is mounted. In some embodiments, the drape includes cutouts, tears, and / or other movable or removable portions that provide for wrapping or otherwise positioning the drape over a base, which may be significantly larger in size than the surgical device itself. In some embodiments, the drape is positioned over the base in such a way that electrical connections (e.g., cables) and / or handles of the base protrude through the drape or openings therein.

[0044] One aspect of some embodiments relates to an adhesive attachment in the form of a peel tab with a structure for attaching an adhesive strip without sacrificing sterility. In some embodiments, the peel tab comprises a strip of release paper that wraps from the interior side of the drape (the side facing the device) toward the exterior side of the drape. The interior edge of the release paper is bonded to the adhesive strip, and when the exterior edge is pulled, the release paper is peeled away from the adhesive strip, allowing a sterile user to attach the interior side of the drape to a non-sterile device. Potential advantages of a structure that does not form direct contact with the adhesive strip may include maintaining sterility while allowing the drape to be attached to a device.

[0045] The surgical devices referred to herein may include an actuation unit for a robotic arm, such as a motor unit to which one or more surgical arms may be attached. Other devices contemplated herein may include, for example, a surgical device that includes one or more extensions, such as a punch and associated motor.

[0046] The device extensions referred to herein can include surgical arms, e.g., mechanical arms, optionally equipped with one or more end effectors (such as scissors, graspers, electrosurgical tips, and / or other surgical tools) for performing surgery. In some embodiments, the device extensions include cameras and / or other diagnostic tools, surgical working channels, microsurgical tools such as those used in sterilization procedures, and / or other surgical tools that optionally extend from a non-sterile machine (such as a motor unit or control console) into a sterile environment.

[0047] As referred to herein, a "first drape sheet," "first drape portion," "base drape," or "base drape portion" may include a drape that is initially deployed over a surgical device and that, when the drape is deployed, includes at least one opening, such as an accessible opening through which exposes an access port of the surgical device. Optionally, the accessible opening in the drape is shaped and sized to further expose an exit aperture of the surgical device through which a device extension (e.g., one or more surgical arms) extends. In some embodiments, the first drape includes at least one fastening element, e.g., a flexible or deformable strip, for securing the drape over the surgical device. In some embodiments, the first drape is sterilized, e.g., during or after manufacture, by an EtO (ethylene oxide) sterilization process and / or other process suitable for reducing or eliminating infectious agents (e.g., bacteria).

[0048] In some embodiments, the first drape forms a sleeve-like shape (see, e.g., FIGS. 17A-17C) when unfolded from a folded, compressed configuration (see, e.g., FIG. 13B). In some embodiments, the sleeve includes an open end, which provides for placing the drape over a surgical device. In some embodiments, when dressing the drape over a surgical device, the direction of unfolding is from distal to proximal, from the front of the device (including the exit aperture for the surgical arm) to the rear of the device. Then, in some embodiments, the edges of the drape are pulled or allowed to hang downward, such as toward the ground.

[0049] In some embodiments, the first drape defines a longitudinal axis that substantially corresponds to (or is parallel to) the longitudinal axis of the surgical device (as shown for example in Figures 17A-17C), a lateral (width) axis that is perpendicular to the longitudinal axis, and in some embodiments, a height axis that extends, for example, from the top of the covered surgical device to the lower end of the surgical device and / or the bottom of the base on which the surgical device is placed.

[0050] In some embodiments, the accessible opening in the first drape is formed as two distinct openings, optionally with the location and / or size of one of the openings corresponding to the location and / or size of an access port of the surgical device and the location and / or size of the second opening corresponding to the location and / or size of an exit aperture of the surgical device.

[0051] In some embodiments, in a drape including a single accessible opening, when the drape is unfolded, the accessible opening extends from a portion of a first surface (e.g., the upper surface) of the surgical device to an adjacent, optionally perpendicular, surface (e.g., the distal surface) of the surgical device.

[0052] As referred to herein, a "second drape sheet," "second drape portion," "covering drape," or "covering drape portion" may include a drape that is deployed over a surgical device after deployment of a first drape sheet or portion. In some embodiments, the second drape is shaped and sized to at least partially cover an accessible opening defined in the first drape. In some embodiments, the second drape covers a surface area of ​​the accessible opening corresponding to the location of the motor unit access port and only partially covers (or, in some embodiments, does not cover) a surface area of ​​the accessible opening corresponding to the location of the motor unit exit aperture (i.e., from which one or more surgical arms extend). Optionally, the second drape completely covers the opening along one side of the covered surgical device (e.g., along the top side of the surgical device) and only partially covers the opening along an adjacent, optionally perpendicular, side (e.g., the distal side) of the covered surgical device.

[0053] In some embodiments, the second drape is formed as a sleeve. Optionally, the sleeve is sized to have a larger cross-sectional area than the first drape so that when unfolded, it can be placed over and optionally surround the first drape. Alternatively, the second drape is formed as a sheet and / or other shape. Optionally, the second drape is shaped and sized so that when placed over or positioned over the first drape, it can be aligned with the first drape and / or with the opening in the first drape and / or with the surgical device.

[0054] In some embodiments, the second drape is sterilized, for example, during or after manufacture, by an EtO (ethylene oxide) sterilization process and / or other process suitable for reducing or eliminating infectious agents (e.g., bacteria).

[0055] Potential advantages of a two-part drape (or two separate drapes) compared to a single-component drape may include minimizing exposure of non-sterile fields of a surgical device and preventing the need to replace the entire drape when attaching, removing, and / or replacing device extensions, such as when attaching, removing, and / or replacing one or more surgical arms on a draped motor unit.

[0056] Before describing at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of components and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0057] Referring now to the drawings, Figure 1 is a flowchart of a method for surgical draping a device including attachable extensions, according to some embodiments.

[0058] To maintain sterility in an operating room, some surgical devices and typically the patient themselves are covered with sterile coverings. Protecting operating room equipment with sterile coverings can, in some cases, reduce the risk of contamination and potentially reduce the risk of infection to the patient. In some embodiments, during operating room preparation, operating room personnel, such as physicians, nurses, technicians, and / or others, prepare the equipment by sterilizing it and / or placing protective drapes or other coverings over the equipment or portions thereof. In some embodiments, surgical drapes are placed to separate between sterile and non-sterile zones and / or components. In some embodiments, surgical drapes are placed to reduce contact of devices with potentially contaminated materials, such as biological fluids.

[0059] In some embodiments, the surgical drape is unfolded (101) from a packed and folded state to an expanded, deployed state that allows the drape to be deployed over a surgical device. In some embodiments, in the expanded state, the drape is unfolded into a substantially flat configuration to overlie the surgical device. In some embodiments, the drape in the expanded state is shaped and sized to cover the surgical device.

[0060] As an example, a surgical device includes a motor unit of a robotic surgical arm, and a drape is configured to cover the motor unit while allowing one or more device extensions, such as a robotic arm, to protrude therefrom for performing surgery. Potential advantages of such a configuration may include reducing the need to sterilize the motor unit itself. Another advantage may include the ability to attach or detach one or more robotic arms to or from the motor unit while the motor unit remains substantially sterile while covered by the drape. In some embodiments, the device extensions (e.g., robotic arms) are sterilized prior to use. Additionally or alternatively, the device extensions are covered or inserted within a sterile sheath. Optionally, the sheath is removed prior to introducing the extensions into the patient's body.

[0061] In some embodiments, the drape is pulled over the device to cover it (103). Optionally, when unfolded, the drape covers a majority of the exposed surface area of ​​the device, e.g., covering at least the top and sides of the device. In the example of a box-shaped motor unit, the drape in its flat, expanded state (before being placed on the motor unit) has a rectangular cross-section so that when unfolded on the motor unit, it covers the top and sides of the box-shaped motor unit, covering the motor unit with the free edge of the sheet overhanging the motor unit's edge. In some embodiments, the drape is sized to cover at least 80%, at least 85%, at least 90%, at least 95%, or any intermediate, greater, or lesser percentage of the motor unit's external surface area. In some embodiments, the user orients and aligns the drape during unfolding so that the opening in the drape is aligned with the access port on the device.

[0062] In some embodiments, after initial placement of the drape on the device (e.g., motor unit), further adjustment of the position of the drape relative to the device may be necessary. In some embodiments, the drape is stretched over the device, centered relative to the device, axially aligned relative to the device, and / or otherwise adjusted or repositioned to fit closely to the device (this can be analogous to placing a tablecloth on a table). Thus, in some embodiments, the drape comprises one or more elements to facilitate alignment of the drape relative to the device and / or attachment of the drape to the device to maintain the drape in a fixed position.

[0063] In one example, the fastening elements are provided in the form of deformable semi-rigid strips. In some embodiments, the semi-rigid strips are embedded in the drape sheet, or alternatively, the strips are attached to the drape sheet. In one example, the semi-rigid strips comprise coated flexible wire.

[0064] In some embodiments, following initial deployment of the drape onto the device, the user attaches a fixation element to the surgical device, e.g., clamping a semi-rigid strip into a designated area of ​​the device, thereby aligning or maintaining alignment of another portion of the drape with the device, e.g., an opening formed in the drape with an access port through which one or more device extensions can be attached (105). In some embodiments, the designated area of ​​the device (e.g., the motor unit) to which the semi-rigid strip is attached comprises a special shape, indicia, or marking to facilitate placement of the strip. For example, the location may be indicated by an indentation, an elongated slot through which the strip is inserted, color markings, a bulge, a corner around which the strip is folded, and / or other structural and / or visible features to indicate the location of attachment of the strip.

[0065] FIG. 2 schematically illustrates deployment of a drape including a deformable element (eg, a semi-rigid strip) and an opening for attachment to an access port of a surgical device, according to some embodiments.

[0066] In some embodiments, the drape 201 is formed of a disposable, clear, flexible, tear-resistant material, such as plastic, nylon, and / or certain fabric materials. In some embodiments, the drape is formed of one or more of thermoplastic polyurethane, ultra-high molecular weight polyethylene, low-density polyethylene, and / or high-density polyethylene. Optionally, the drape comprises welded or stitched sheets.

[0067] In some embodiments, drape 201 comprises a semi-rigid strip 203. Optionally, strip 203 is attached or embedded within a proximal portion 205 of the drape. In some embodiments, strip 203 extends along the central longitudinal axis 207 of the drape, for example, along 1 / 10, 1 / 8, 1 / 5, 1 / 3, or 1 / 4 of the total length of axis 207. Strip 203 may extend from a proximal-most point on axis 207, or in some embodiments, may extend further along the axis from the point.

[0068] In some embodiments, drape 201 has an opening 209 formed therein. In some embodiments, opening 209 is formed in a distal portion 211 of the drape. In some embodiments, opening 209 is shaped and / or sized such that when drape 201 is placed over device 213, the opening overlaps with access port 215 of device 213 to which one or more device extensions 217 may be connected. In some embodiments, opening 209 is formed along central longitudinal axis 207. Optionally, opening 209 is rectangular. Openings of other shapes, such as round, triangular, square, or any shape, are also contemplated by the present application.

[0069] In some embodiments, the openings 209 and semi-rigid strips 203 are linearly aligned with one another. Other embodiments may include different relative positions of the openings and semi-rigid strips. Optionally, the openings and semi-rigid strips are positioned opposite one another, such as opposite one another at opposite ends of the drape sheet.

[0070] In some embodiments, semi-rigid strip 203 is pinched, folded, and / or otherwise temporarily affixed to device 213 when drape 201 is placed over device 213. In the example shown herein, strip 203 is folded over a proximally facing corner of the top of the device, thereby aligning opening 209 with access port 215. In some embodiments, attaching the strip to the device (e.g., by folding over a corner, inserting into a predetermined slot, and / or other attachment method) stretches the drape to fit closely to at least the top surface of the device. In some embodiments, attaching the strip to the device centers the drape relative to the device, e.g., centering it about axis 217 extending along the wide dimension of the top surface of the device.

[0071] In some embodiments, the semi-rigid strip is configured to plastically deform upon application. In some embodiments, the strip deforms to conform to the shape of the external device housing, for example, folding to conform to the angle of a corner 221 of the device. Optionally, deforming the strip changes the planar configuration of the drape. Optionally, the semi-rigid strip helps the drape maintain the new planar configuration it assumes by supporting portions of the drape, such as portions of the drape that are facing in different directions after deformation of the strip.

[0072] In some embodiments, the lining 219 of the opening 209 in the drape includes one or more deformable elements, such as semi-rigid strips. Optionally, the lining provides a support frame for the opening, which may assist in positioning the opening to overlap with the access port 215 of the device.

[0073] In some embodiments, the opening 209 is shaped and / or positioned to allow one or more device extensions 217, such as surgical arms, to extend distally from the access port 215.

[0074] Alternative embodiments may include a drape including an opening, e.g., facing proximally, at a proximal portion of the drape; such an arrangement is useful for devices in which an access port for receiving a device extension is located on the proximal surface of the device (e.g., insertion of a surgical arm into the motor unit occurs from the proximal surface of the device). Other embodiments may include openings located at various positions, e.g., along the sidewall surface of the unfolded drape sheet. Some embodiments may not include openings. Optionally, the drape portion may simply be lifted or otherwise pushed aside to allow access to the access port.

[0075] In some embodiments, the drape includes two openings: a first opening that aligns with an access port on the top surface of the surgical device and a second opening that aligns with an exit aperture of the surgical device from which one or more surgical arms extend. Optionally, the exit aperture is located on the front (distal) facing surface of the surgical device. Alternatively, a single opening in the drape is shaped and sized to expose both the access port and the exit aperture of the surgical device, and optionally overlaps an adjacent (optionally perpendicular) surface of the surgical device.

[0076] FIG. 3 is a flowchart of a method for surgically draping a device with modular extensions, according to some embodiments.

[0077] In some embodiments, a drape is unfolded (301) from a folded, compressed configuration. The unfolded drape is then placed over a device (303). Optionally, unfolding of the drape is aided by one or more markings, openings, fasteners, plastically deformable elements, and / or other components embedded within and / or attached to the drape. Additionally or alternatively, unfolding of the drape is aided by covering one or more markings, openings, protruding structures, indentations, and / or other components of the device.

[0078] In some embodiments, a drape is placed over the device and aligned so that an opening formed in the drape coincides with an access port of the device to which one or more device extensions will be attached. In some embodiments, once the opening aligns with the access port, the device extensions are loaded into the device (305). In one example, a surgical arm is loaded through one or more doors configured in the access port.

[0079] In some embodiments, optionally, after loading of the surgical arms, the access port is at least partially covered by a drape portion (307). In some embodiments, the opening of a drape already attached to the device is covered by the drape portion, with the drape portion covering at least 95%, 90%, 85%, or an intermediate, higher or lower percentage of the surface area of ​​the opening. In some embodiments, the drape or drape portion at least partially covering the opening defined in the initially deployed drape is shaped and sized to cover between 50% and 80%, between 60% and 90%, between 70% and 95%, or an intermediate, higher or lower range of the surface area defined by the opening of the initially deployed drape. In some embodiments, the covering drape portion is shaped, sized, and / or positioned to cover the access port of the surgical device but only partially cover or not cover the exit aperture of the surgical device through which a distal device extension (e.g., one or more surgical arms) may protrude.

[0080] In some embodiments, a one-piece drape sheet is provided that includes a first portion having an opening formed therein and a second portion for further covering the device area exposed by the opening. Optionally, the second portion is sewn or welded to the first portion. Optionally, the second portion is attached to the first portion by a tear-off attachment.

[0081] In some embodiments, the second portion is packaged in a folded state and unfolded only when needed to cover exposed device areas, for example, after loading a surgical arm onto the device. Optionally, the folded portion is maintained in a predetermined pocket or fold formed in the first portion. In some embodiments, the second portion can be pushed away from the opening, for example, to allow access to the access port (e.g., for removal or replacement of a device extension). Optionally, the pushed-away portion is gripped by a clip, adhesive means, and / or other attachment to the device. Gripping the pushed-away portion to prevent contact with the surroundings is believed to contribute to maintaining sterility.

[0082] Additionally, the second portion can be torn off (and optionally discarded) upon removal or replacement of the device extension.

[0083] The drape may also be comprised of two sheets, one with an opening formed in it and the second shaped and sized to substantially cover the area of ​​the device exposed through the opening. In some embodiments, the second sheet is removed (and optionally discarded) upon removal or replacement of the device extension. Optionally, the first sheet remains in place on the device, and the second sheet is replaced with a new sheet.

[0084] Potential advantages of a drape that includes a movable or removable portion for placement over the access port and / or exit aperture through which the device extension extends may include the ability to attach, remove, or replace the device extension even during surgery while reducing exposure of the device.

[0085] In some embodiments, the second drape comprises multiple portions, for example, a first portion covering a top surface of the motor unit (e.g., when the motor unit is covered by the first drape) and a second portion covering a front (i.e., distal) surface of the motor unit (e.g., when the motor unit is covered by the first drape). Optionally, the multiple portions comprising the second drape at least partially overlap each other.

[0086] 4A-4B show schematic diagrams of the top (4A) and distal (4B) surfaces of a device with distal extensions when covered with a sterile drape, according to some embodiments.

[0087] In some embodiments, drape 401 includes an opening 402 (optionally formed as a notch) shaped and sized to expose an access port of a surgical device (in example, a motor unit of a robotic arm). In some embodiments, the drape opening, when deployed over the device, extends from the top surface to the distal surface, with a device extension (not shown) extending distally therefrom. In some embodiments, the device extension is loaded to extend through the access port, e.g., through one or more doors 407 disposed on the top surface, out of a designated exit aperture 409 on the distal surface of the device. In some embodiments, the loaded extension is linearly aligned along or parallel to the long axis 411 of the device. In some embodiments, door 407 is also positioned along or parallel to long axis 411. Optionally, when door 407 is closed, the top surface of the device is flat, preventing the door from interfering with drape deployment. Potential advantages of a device with a flat surface may include maximizing the contact area between the device surface and the drape, thereby minimizing the ingress of contaminants into the space between the device and the drape.

[0088] In some embodiments, a second drape portion (which may be integrally attached to drape 401, separable from drape 401, or in some embodiments formed as a separate, distinct drape sheet) substantially covers opening 402 such that the exposed access port, exit aperture, and surrounding area are protected by the second drape portion. In some embodiments, the second drape portion includes opposing valley folds 415 onto which a user's hands can be placed during deployment. When the second drape portion is deployed over the device, the valley folds define a curtain-like arrangement that allows the device extensions to protrude outward. In some embodiments, in addition to or instead of the valley folds, the drape includes handling means such as handles, straps, pull cords, or other means that can facilitate deployment of the drape by the user.

[0089] FIG. 5 is a flowchart of a method for covering a surgical device with a sterile drape comprising two separate sheets, according to some embodiments.

[0090] In some embodiments, the drape comprises first and second (eg, upper and lower) sheets that are deployed over the device before and after loading of the distal device extensions.

[0091] In some embodiments, a first drape portion (in one example, a first drape sheet) is unfolded from a compressed state and placed over the device (501, 503). Optionally, the drape is formed as a sleeve with an open bottom so that it can be placed over the device and pulled over the device in a direction from the top surface of the device toward the bottom surface of the device. Optionally, one or more deformable elements, such as semi-rigid strips, can be manipulated by the user to attach the drape to the device (505) at a preselected device location or alternatively in any manner. In some embodiments, one or more attachment means, such as adhesives, are used to further bond and / or align and / or secure the drape to the device (507). Once the first drape portion is in place, the device's access port remains exposed (509) so that it can be loaded through the distal device extension. Following loading of the distal device extension, a second drape portion (in this example, a second drape sheet) is unfolded from a compressed state (511). Optionally, the second drape portion is attached to the first drape portion according to one or more orientation markings (513) (optionally, the markings include adhesive). Optionally, the markings are located at designated bonding locations between the first and second drape portions. In some embodiments, when folded, the second drape portion includes a valley fold for positioning a user's hand (515), which may help guide the user during unfolding, for example, by indicating the direction in which the second drape portion needs to be pulled over the first drape portion. Optionally, the second drape portion is pulled from the proximal end toward the distal end of the surgical device, optionally along the length of the device, until the valley fold is positioned extending along at least a portion of the distal face of the device. In some embodiments, the user then presses within the valley fold to attach the "flaps" defined by the valley fold to the distal face of the device (517). Optionally, the flaps are positioned relative to one another to allow distal device extensions to protrude between them.The user then releases the valley fold 519. At this stage, the unfolded drape portion provides sterile isolation of the device from its environment.

[0092] FIG. 6 is a flowchart of a method for exchanging distal device extensions mid-procedure while maintaining sterility of the device, according to some embodiments.

[0093] During surgery, it may be necessary to remove or replace one or more device extensions, e.g., surgical arms, to insert a particular size or configuration of surgical arm, to reduce or increase the number of arms used, and / or to perform specialized surgical actions such as drilling, stapling, suturing tissue, sharply cutting tissue, etc.

[0094] In some embodiments, a drape portion or separate drape sheet covering the exposed device access port and optionally the exit aperture of the distal extension is removed (601). Alternatively, the drape portion or separate drape sheet is pushed aside, folded, and / or otherwise moved away from the device access port and / or the exit aperture of the device extension. Optionally, the pushed aside portion is stored in a predetermined pocket formed in the drape or held in a compressed or folded state to reduce contact with the environment.

[0095] In some embodiments, removal of the drape portion exposes only a minimal surface area of ​​the device, e.g., limited to only the access port door, to allow for removal or replacement of the device extension (603). In some embodiments, only 5%, 10%, 15%, or any intermediate, higher or lower percentage of the total surface area of ​​the device previously covered by the drape is exposed for the process of device extension replacement or removal. Potential advantages of drapes designed to expose only selected, minimal areas of the surgical device include a greater likelihood of maintaining sterility compared to situations where, for example, the entire drape must be removed from the device to allow for removal or replacement of the device extension.

[0096] Replacing one or more device extensions, e.g., one or more surgical arms, can be accomplished by opening the access port door, lifting the arm from the device, inserting the new arm through the open door, and closing the door to lock the arm in place.

[0097] In some embodiments, when a device extension is modified (e.g., a surgical arm is removed, replaced, or added), the exposed device area is re-covered by a drape portion. In some embodiments, a new drape sheet may be deployed over the device. Alternatively, additionally, or instead, a previously stowed drape portion is repositioned (605) over the exposed device area (e.g., access port).

[0098] 7A-7B are schematic illustrations of bottom (7A) and top (7B) drape sheets for covering a surgical device with distal extensions, according to some embodiments.

[0099] The exemplary bottom drape sheet of FIG. 7A is shown in cross section. An opening 701 (e.g., a cutout in the drape sheet) is formed at the top distal angle of the drape. In some embodiments, opening 701 forms an angle α with respect to the major axis 703 of the drape, ranging from, for example, 1 to 30 degrees, e.g., 5 degrees, 10 degrees, 20 degrees, or an intermediate angle, higher angle, or smaller angle. In some embodiments, opening 701 forms an angle β with respect to an axis 705 extending along the height dimension of the bottom drape, ranging from, for example, 60 to 90 degrees, or an intermediate, higher, or smaller angle, e.g., 70 degrees, 80 degrees, 85 degrees. Opening 701 is large enough to expose selected regions of the upper and / or distal surface of the surgical device when deployed, e.g., an access port configured on the upper surface of the device and an exit aperture in a distal extension on the distal surface of the device.

[0100] In some embodiments, one or more adhesives, such as a peel tab 707, are positioned along the distal surface of the bottom drape, optionally directly below the opening 701. In some embodiments, the peel tab is positioned to attach the bottom drape to the device at a location directly below the extension's exit aperture. Another peel tab 711 may be positioned on the top surface of the drape adjacent the opening 701. Placing an adhesive, such as a peel tab, adjacent the border of the drape's opening can ensure adhesion of the drape in areas prone to contaminant entry. Additional adhesives, such as hook-and-loop fasteners 709 (e.g., Velcro attachments), may be positioned at different locations along the drape. The bottom drape may include attachment means, such as adhesives, on the inner surface of the drape facing the device and / or on the outer surface of the drape, such as for attachment to a top drape.

[0101] In some embodiments, the bottom drape comprises a deformable element, such as a semi-rigid strip 713 (e.g., as described herein). Optionally, the deformable strip is disposed along the longitudinal axis 703. Optionally, the strip 713 is adjacent the proximal side of the drape and can bend over the upper proximal corners of the device upon deployment, thereby potentially assisting in orienting and centering the opening 701.

[0102] Exemplary dimensions of the bottom drape when stretched can include lengths (measured along axis 703) of, for example, 2 m, 2.5 m, 3 m, or any intermediate, larger, or smaller size, and heights (measured along axis 705) of, for example, 70 cm, 80 cm, 60 cm, or any intermediate, larger, or smaller size.

[0103] In a compressed, folded state (not shown herein) of the bottom drape, the dimensions can include a length (measured along axis 703) of, for example, 250 cm, 200 cm, 300 cm, or intermediate, larger, or smaller sizes, and a height (measured along axis 705) of, for example, 70 cm, 80 cm, 60 cm, or intermediate, larger, or smaller sizes.

[0104] The exemplary top drape sheet in FIG. 7B is shown in a stretched, unfolded state. In some embodiments, the top drape includes a set of opposing valley folds 715, for example, configured along the distal surface of the unfolded sheet. Optionally, a user places their hands on the valley folds to pull the top drape over the bottom drape during deployment onto the device. Potential benefits of valley folds designed for user hand placement may include facilitating deployment of the top drape, reducing unnecessary contact between the user and the drape, and helping to direct and orient the drape over the device during deployment.

[0105] In some embodiments, adhesives such as hook and loop attachments 709 are positioned on the inside of the valley fold that faces the distal surface of the device when the drape is unfolded. In some embodiments, the adhesives on the top drape are positioned to attach to exposed surface areas of the device itself. Additionally or alternatively, the adhesives on the top drape are positioned to attach to the outer surface of the bottom drape.

[0106] In some embodiments, the top drape comprises one or more deformable elements, such as semi-rigid strips 717. Optionally, strips 717 are positioned to overlap strips 713 of the bottom drape upon deployment, which may help guide the top drape into its final deployed position.

[0107] In some embodiments, the top drape comprises a flexible band 719, formed of, for example, nylon, extending outward from the distal surface of the drape sheet. In some embodiments, the band 719 is long enough to allow the band to loop around the exit aperture of the device extension when the top drape is deployed. By wrapping the band 719 around the exit aperture, and optionally around the shaft of the device extension, the band can help 1. support and secure the device extension at the exit aperture, and 2. reduce the surface area exposed around the exit aperture.

[0108] In some embodiments, the dimensions of the top drape may include a length measured along axis 721, e.g., 400 cm, 500 cm, 750 cm, or intermediate, larger, or smaller sizes, and a width measured along axis 723, e.g., 200 cm, 250 cm, 350 cm, or intermediate, larger, or smaller sizes.

[0109] Exemplary dimensions of the folded top drape sheet can include, for example, a length measured along axis 721 of, for example, 200 cm, 213 cm, 250 cm, or intermediate, larger, or smaller sizes, and a width measured along axis 723 of, for example, 145 cm, 120 cm, 160 cm, or intermediate, larger, or smaller sizes.

[0110] The bottom drape is large enough to cover the motor unit and also extend to cover the fixation arms that secure the motor unit to the operating table.

[0111] In some embodiments, the top drape is large enough to completely cover at least the opening in the bottom drape.

[0112] In some embodiments, the top and / or bottom drape sheets in the folded, compact state include indicia (optionally including adhesives, folds, and / or color markings) to indicate the direction of unfolding and / or deployment of the device.

[0113] FIG. 8 is a schematic diagram of a drape adhesive in the form of a peel tab 801, according to some embodiments.

[0114] In some embodiments, the peel tab is configured to allow a user to peel back release paper 803 to expose adhesive strip 805 without compromising sterility. In use, a user pulls release paper 803, which wraps around from sterile side 807 (against drape sheet 808, i.e., the outer side of the drape) toward non-sterile side 809 of the drape sheet. Because the release paper terminates in adhesive strip 807, the ring-like shape of the release paper allows it to be pulled away from the adhesive strip without directly contacting it. Once the adhesive strip is exposed, the adhesive strip can be pressed against the surface of the device (or against another drape portion) to attach drape sheet 808.

[0115] Other attachment means include stickers, clips, zippers, snaps, double locking fasteners (such as hook and loop fasteners), fasteners with interlocking flat fastener surfaces, and the like.

[0116] FIG. 9 is a schematic diagram illustrating a surgical drape including a foldable portion, according to some embodiments.

[0117] In some embodiments, foldable drape portion 901 is configured within predetermined pockets or folds 903 formed in drape sheet 905. Optionally, during use, drape sheet 905 is unfolded over the surgical device such that opening 907 in the drape sheet exposes access ports for attachment of distal device extensions, and optionally exit apertures for the distal device extensions. During initial deployment, portion 901 may be stowed, and after loading of the device extensions, portion 901 may be pulled or unfolded to cover exposed device areas. Optionally, portion 901 includes one or more adhesives for attachment to the surface of the device and / or drape sheet 905 at selected locations.

[0118] 10A-10B are images of a bottom drape sheet deployed over a motor unit of a surgical arm, according to some embodiments.

[0119] FIG. 10A is an image of the distal face of motor unit 1001, with surgical arm 1003 extending distally outward therefrom. FIG. 10B is an image of a side view of the motor unit. As can be seen, in some embodiments, a bottom drape sheet 1005 is positioned over the motor unit such that an opening formed in the drape exposes an access port including a loading door 1007 for attachment of arm 1003, and also exposes exit aperture 1009 through which the arm extends outward. In this example, a pair of stickers 1011 are positioned opposite and adjacent exit aperture 1009 and can be attached to the surface of the motor unit by pulling marked tabs 1013. In some embodiments, one or more arrows 1031 (or other directional markings) indicate the direction in which to pull the stickers.

[0120] In an exemplary embodiment, the dimensions of the cutout at the distal device face include widths 1015 of between 5 cm, 10 cm, or 15 cm, or intermediate, larger, or smaller sizes, for example, to allow a drape to fit directly underneath and adjacent to the exit aperture 1009.

[0121] In some embodiments, the bottom drape includes colored lines 1019 that mark the limits of the sterile zone. Exemplary dimensions of the sterile zone as viewed from the side of the motor unit may include a length 1021 of 300 cm, 250 cm, 400 cm, or intermediate, larger, or smaller sizes, and a height 1023 of 15 cm, 20 cm, or 25 cm, or intermediate, larger, or smaller sizes.

[0122] 11A-11B are images of a top drape sheet deployed over a motor unit of a surgical arm, according to some embodiments. The front view in FIG. 11A shows the top drape 1101 covering the motor unit 1103, with a pair of surgical arms 1105 extending distally therefrom. In some embodiments, the top drape includes a valley fold 1107 sized for positioning a user's hands during deployment over the motor unit. Optionally, in the final deployed position, the valley fold 1107 extends along the distal face of the motor unit on opposite sides of the exit aperture from which the surgical arms extend.

[0123] 11B is a side view of the covered motor unit. In some embodiments, the top drape includes a lining 1109 to indicate a sterile field.

[0124] In some embodiments, the top drape 1101 comprises at least two portions: a first portion (1113, shown schematically in FIG. 11B) shaped and / or sized to at least cover the access port 1111 exposed by the opening in the bottom drape, and a second portion (1115, shown schematically in FIG. 11A) shaped and / or sized to extend along the front (distal) face of the motor while still exposing the motor unit's exit aperture 1117 through which one or more surgical arms 1105 may protrude.

[0125] 12 is an image of a deformable drape element in the form of a semi-rigid strip 1201, according to some embodiments. In some embodiments, the semi-rigid strip comprises a wire coated with a plastic coating. Optionally, the strip is embedded within the drape material. Alternatively, the strip is attached to the drape.

[0126] 13A-13C are images of an extended bottom drape (13A), a folded bottom drape (13B), and a folded top drape (13C) (when not deployed over the motor unit), according to some embodiments. In some embodiments, the top and / or bottom drapes include one or more markings, such as arrows 1301, visible in the folded and / or extended positions, positioned to help guide the user during drape deployment.

[0127] In some embodiments, valley folds 1303 for placement of the user's hands are accessible in the folded configuration of the drape.

[0128] In some embodiments, stickers 1305 or other markings that can assist with orientation during deployment of the drape are clearly visible in the folded and / or unfolded state of the drape.

[0129] In some embodiments, the top and / or bottom drapes include one or more adhesives 1307 for attaching the drapes to the motor device and / or for attaching the top and bottom drapes to each other.

[0130] In some embodiments, as shown, for example, in FIG. 13A, the bottom drape is sleeve-like and includes an open end (the direction of the open end is indicated at 1309; the drape is shown folded but may extend further when unfolded in the direction indicated at 1311). In some embodiments, a partially closed end 1313 of the sleeve is configured opposite the open end. In some embodiments, the body 1315 of the drape, which extends between the open end and the partially closed end, is tubular and hollow.

[0131] As used herein, a "partially occluded" end may include a side or end of a sleeve of a drape that is sealed along a portion of its length and open along another portion of its length, optionally with the majority of the length sealed. In some embodiments, in use, the partially occluded end of the deployed drape covers the distal face of the surgical device such that the exit aperture remains exposed but the remainder of the distal face is covered.

[0132] In some embodiments, an accessible opening 1317 (shown by a dashed line) is defined in the sleeve, extending from the partially closed end 1313 to a side edge 1319 of the tubular body 1315 of the drape. In some embodiments, the accessible opening is defined by a cutout in the drape. In some embodiments, the accessible opening is rectangular. Optionally, as shown in this photograph, for example, the accessible opening comprises a stepped profile. In some embodiments, in use, a portion of the accessible opening (e.g., the portion extending along the closed end of the sleeve) overlaps with an exit aperture of a surgical device (e.g., the exit aperture of a motor unit from which one or more surgical arms extend), and another portion of the accessible opening (e.g., the portion extending along a segment of edge 1319) overlaps with an access port of the surgical device.

[0133] It should be noted that the accessible opening may have a rectangular, triangular, circular, arbitrary shape, and other shapes and profiles.

[0134] Potential advantages of sleeve-type drapes may include reducing or avoiding the need to tie loose ends of a drape, such as a single-layer flat sheet drape, when the drape is deployed over a surgical device. In some embodiments mentioned herein, because the surgical device is narrow and elongated, deployment of the drape over the surgical device may be facilitated by using a sleeve-shaped drape. Another potential advantage of sleeve-like drapes is that there are no free ends of the sleeve, or at least they need to be tied or otherwise attached to each other, improving sterile coverage and reducing exposure of the device to the environment (or vice versa).

[0135] 14A-14E schematically illustrate drape sheets that include removable portions that, when removed, form openings in the sheet, according to some embodiments.

[0136] In some embodiments, drape sheet 1401 includes removable or movable portion 1403 that, when removed (or moved), defines opening 1407 in the drape sleeve, exposing surgical device access port 1431 (see FIG. 14C ). Optionally, portion 1403 is attached to the drape by a tear bond so that it can be separated from the sleeve, e.g., by pulling on the portion. Additionally or alternatively, the portion is removably attached to the sheet, e.g., by adhesive, e.g., via sticky tape, adhesive, and / or the like.

[0137] FIG. 14A shows a schematic side view of drape 1401 folded along the drape's long axis while portion 1403 is still attached to the drape. The seams of removable / movable portion 1403 are shown with dashed lines. In FIG. 14B, portion 1403 is removed, according to some embodiments, thereby forming an opening through which the motor unit access port can be exposed. FIG. 14C shows a top view of the drape sheet when unfolded over the motor unit, according to some embodiments. FIG. 14D shows a side view of the drape sheet when unfolded over the motor unit, according to some embodiments. FIG. 14E shows a front view of the drape sheet when unfolded over the motor unit, according to some embodiments. Optionally, removal of portion 1403 exposes motor unit exit aperture 1405, for example, from which one or more surgical arms may extend distally.

[0138] In some embodiments, portion 1403 (and thus opening 1407 formed upon removal or movement of portion 1403) is shaped and sized to match the shape and / or size of the access port and exit aperture of the motor unit. Optionally, portion 1403 fits snugly over the access port and exit aperture and does not extend beyond the boundaries of the access port and exit aperture, exposing only those portions of the motor unit and not other portions when removed. Optionally, the surface area of ​​portion 1403 corresponds to the combined surface area of ​​the access port and exit aperture of the motor unit. Optionally, the surface area of ​​portion 1403 approaches the sum of the surface areas of the access port and exit aperture. In the illustrated example, portion 1403 is formed to have a stepped profile, e.g., defining two steps. Optionally, a majority of the opening formed by the upper step 1409 is configured to expose the access port of the motor unit, and a small portion of the opening formed by the lower step 1411 is configured to extend directly below the exit aperture of the motor unit when the drape is deployed over the motor unit (e.g., as shown in FIG. 14E).

[0139] Alternatively, portion 1403 is shaped and / or sized to be larger than the access port and exit aperture. For example, portion 1403 may be formed with a rectangular side profile, e.g., such that when the drape is deployed over the motor unit, the bottom edge of the rectangle extends below the exit aperture.

[0140] 14C , portion 1403 defines an opening through which an access port of a surgical device is exposed, and fasteners 1415 (e.g., deformable strips) for attaching the drape to the proximal end of the surgical device are located at a distance 1419 of 10-20 cm from each other, e.g., 14 cm, 16 cm, 18 cm, or an intermediate, longer, or shorter distance, e.g., when measured from the proximal end of portion 1403 to the distal end of fasteners 1415. Optionally, portion 1403 and fasteners 1415 are located opposite each other along an axis, which in some embodiments is the major axis 1417 of the drape. Optionally, portion 1403 and fasteners 1415 are centered relative to major axis 1417. In some embodiments, distance 1419 corresponds to the distance between the access port of the surgical device (e.g., a motor unit) and the proximal end of the surgical device, e.g., the proximal face of the motor unit.

[0141] Note that in some embodiments, the drape includes two or more fixation elements for securing the drape to the motor unit, e.g., 2, 5, 6, 10 fixation elements, or an intermediate, larger, or smaller number of fixation elements. Optionally, different fixation elements are placed on the drape at locations corresponding to edges or corners of the motor unit.

[0142] 14A, for example, in the unfolded (and undeployed) state, the drape comprises an elongated hollow structure, optionally in the shape of a tubular sleeve. In some embodiments, the sleeve defines an open end 1451 and an opposing partially closed end 1453. In some embodiments, the open ends allow the walls of the sleeve to be pulled apart from one another to place the sleeve over a surgical device.

[0143] In some embodiments, the opening defined by portion 1403 extends from the edge of the partially closed end 1453 to the adjacent edge 1455 of the tubular sleeve, which edge may be substantially perpendicular to the closed end 1453 in the expanded configuration.

[0144] In some embodiments, the long axis 1417 of the drape extends along the edge 1455. In some embodiments, the opening defined at 1403 and the fastening portion 1415 are configured along the long axis.

[0145] In some embodiments, during use, after the drape is deployed over the motor unit (1601), for example, as described in the flowchart of FIG. 16 , a user (e.g., a nurse, physician, and / or other operating room staff) can remove a removable drape portion, thereby exposing the motor unit's access port and / or exit aperture (1603). Additionally or alternatively, the user can move the drape portion, e.g., roll it to the side or up, to push the portion aside and / or otherwise expose the access port. In some embodiments, removal and / or movement of the drape portion occurs only near (e.g., just before) the time of attaching the surgical arm to the motor unit, e.g., not more than 5 minutes, 2 minutes, 30 seconds, 10 seconds, or any intermediate, longer, or shorter period of time, before attaching the surgical arm to the motor unit. Potential benefits of exposing the motor unit's access port by removing (or moving) a drape portion only when attaching the surgical arm to the motor unit may include minimizing exposure of non-sterile portions of the surgical device to the sterile operating room environment. Another potential benefit may include protecting the motor unit (or portions thereof) from contamination as long as possible. At 1605, the surgical arm is attached to the motor unit, for example, by attaching the arm through the exposed access port of the motor unit. At 1607, once the arm is in place, at least a portion of the access port is re-covered, for example, with a second drape sheet, a different portion of the drape sheet originally used, and / or the same portion moved aside or rolled up to expose the access port. Optionally, at the end of the draping process, only the exit aperture remains covered by the drape, allowing the surgical arm to extend therethrough.

[0146] 15A-15C are images of a drape including an opening shaped and sized to expose the motor unit's access port and exit aperture when placed over the motor unit, according to some embodiments. In some embodiments, as shown, for example, in FIG. 15A, the drape 1501 defines an opening with a stepped profile. Optionally, a first step 1503 is shaped, sized, and positioned to fit over the motor unit's access port 1505, as shown, for example, in FIG. 15B, and a second step 1509 is shaped, sized, and positioned to expose the motor unit's exit aperture 1511, which is optionally located on the front of the motor unit 1507, as shown, for example, in FIG. 15C.

[0147] In some embodiments, one or more attachment means 1513, such as adhesives (e.g., stickers, tear-off tabs), magnets, hook-and-loop fasteners and / or other attachment means, are positioned at one or more locations along the boundary of the drape opening to attach the drape to the motor unit.

[0148] In some embodiments, a marker 1515, e.g., in the form of a line of tape, a colored line, and / or other type of marker, extends to distinguish between sterile and non-sterile portions of the drape (e.g., when deployed over the motor unit). In some embodiments, the boundary of the access port is located within the boundary defined by the marker.

[0149] 17A-17D are schematic diagrams illustrating a drape for covering at least a portion of a surgical device and a base to which the surgical device is attached, according to some embodiments.

[0150] In some embodiments, drape 1701 (see generally in FIG. 17D) is shaped and / or sized to cover at least a portion of a surgical device, such as motor unit 1703 (see FIG. 17A), and base 1705 (see FIG. 17A) on which the motor unit sits or is attached. In some embodiments, the base is movable, such as a rolling cart.

[0151] In some embodiments, the drape 1701 includes a first opening 1702 (also referred to as an "accessible opening") to expose the access port 1707 of the motor unit and a second opening 1713 (also referred to as an "extended opening") to facilitate covering the base 1705, which in some embodiments may be of larger dimensions (e.g., larger width, length, and / or height) relative to the motor unit. In one example, the width 1709 of the base 1705 is approximately 25%, 50%, 75%, 100%, 125% larger than the width 1711 of the motor unit 1703.

[0152] Advantages of covering the base with the same drape that covers the motor unit may include ease of use, reducing the number of actions the doctor / nurse must perform to prepare for surgery, and reducing preparation time, such as maintaining sterility with the drape.

[0153] In some embodiments, the tear piece and / or other removable or movable drape portion defines a second opening 1713 to facilitate deployment (e.g., top-to-bottom deployment) of the drape 1701 onto the base 1705 upon removal.

[0154] In some embodiments, after the drape 1701 is unfolded, a top drape sheet and / or other drape portion, or a sterile sheet, is placed over the opening 1713. Optionally, one or more attachment means 1715, such as an adhesive (e.g., a sticker, optionally double-sided), clips, magnets, and / or other attachment means, are placed on the drape 1701 for attachment to a top drape or other portion covering the opening 1713, as shown, for example, in FIG.

[0155] In some embodiments, for example as shown in FIG. 17C, the drape 1701 comprises a second layer 1717 that can be moved, deployed, and / or otherwise positioned to cover the opening 1713.

[0156] 17D shows an example of a drape layout that includes a notch 1719 that allows drape portions configured on its sides to pull apart to form an opening 1713. In some embodiments, the notch 1719 extends along a segment of the drape's long axis. In some embodiments, an opening 1702 for allowing access to the access port is configured opposite the notch 1719, e.g., along the drape's long axis. In some embodiments, a fastener 1721, such as a deformable strip, is positioned intermediate the notch 1719 and the opening 1702.

[0157] FIG. 18 is an image of a drape covering the motor unit while exposing the motor unit's access port and exit aperture, according to some embodiments.

[0158] 18, a drape 1801 is shown partially covering a motor unit 1803 that is attached to a stand (or base) 1805. In some embodiments, the drape 1801 is large enough to cover the stand 1805 along the height of the stand. Optionally, the drape is large enough to extend from the location of the motor unit down to the ground where the stand is located.

[0159] In some embodiments, the drape 1801 comprises an elongated hollow structure, optionally a tubular sleeve.

[0160] In some embodiments, the open end 1807 of the unfolded drape is directed toward the ground. Optionally, the free end of the open end may be tied or secured.

[0161] In some embodiments, the partially occluded end 1809 of the deployed drape faces distally (forward). Optionally, this direction corresponds to the direction in which one or more surgical arms 1811 extend from the motor unit. In some embodiments, in the undeployed state, the partially occluded end 1809 is configured to face the open end 1807, and when the drape is placed over the device, a portion of the drape can be rotated so that the partially occluded end faces a direction substantially perpendicular to the direction in which the open end faces. In some embodiments, this rotation is the result of aligning an accessible opening in the drape with an access port 1815 and / or exit aperture 1817 of the motor unit 1803.

[0162] The terms "comprises," "comprising," "includes," "including," "having," and their conjugations mean "including but not limited to."

[0163] The term "consisting of" means "including and limited to."

[0164] The term "consisting essentially of" means that a composition, method, or structure may include additional ingredients, steps, and / or parts, but only if the additional ingredients, steps, and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0165] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" may include multiple compounds, including mixtures thereof.

[0166] Throughout this application, various embodiments of the present invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the present invention. Thus, the description of a range should be considered to specifically disclose not only each individual numerical value within that range, but also all possible subranges. For example, a description of a range of "1 to 6" should be considered to specifically disclose subranges such as "1 to 3," "1 to 4," "1 to 5," "2 to 4," "2 to 6," "3 to 6," etc., as well as each individual numerical value within that range, e.g., "1," "2," "3," "4," "5," "6," etc. This applies regardless of the breadth of the range.

[0167] When a numerical range is given herein, it is meant to include any recited number (decimal or integer) within the range given. The phrase "ranging between" a first and second reference number and the phrase "ranging from" the first reference number to a second reference number are used interchangeably herein and are meant to include the first and second reference numbers and all decimals and integers therebetween.

[0168] As used herein, the term "method" means any manner, means, technique, or procedure for accomplishing a given task, including, but not limited to, any manner, means, technique, or procedure known to or that can be readily developed by one skilled in the art of chemistry, pharmacy, biology, biochemistry, or medicine.

[0169] As used herein, the term "treating" includes halting, substantially inhibiting, slowing, or reversing the progression of a condition, substantially ameliorating the clinical or cosmetic symptoms of the condition, or substantially preventing the appearance of clinical or cosmetic symptoms of the condition.

[0170] It will be understood that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or with other described embodiments of the invention, as appropriate. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperable without those elements.

[0171] All publications, patents, and patent applications mentioned in this specification are incorporated by reference in their entirety to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. Furthermore, citation or identification of any document in this specification should not be construed as an admission that such document is available as prior art to the present invention. Section headings, to the extent that they are used, should not be construed as necessarily limiting.

[0172] Additionally, all priority documents of this application are incorporated herein by reference in their entirety.

Claims

1. 1. A two-part drape for a surgical device, comprising: I. A first drape portion formed from a thin sheet of flexible material defining an elongated hollow sleeve, an open end on a first side of the sleeve; a partially closed end on an opposing second side of the sleeve; and an elongated sleeve body extending between said open end and said partially closed end; an accessible opening extending from said partially closed end to an adjacent portion of said body of said sleeve; a first drape portion comprising: II. a second drape portion configured to be placed over the first drape portion, the second drape portion being formed from a thin sheet of flexible material, the second drape portion being shaped and sized to at least partially cover the accessible opening; Equipped with A drape, wherein the accessible opening is formed as a cutout that exposes at least a portion of the surgical device when the first drape portion is deployed thereover, the exposed portion of the surgical device comprising an access port that can receive and attach a device extension.

2. The drape of claim 1 , wherein the body of the first drape portion is closed along a long side of the body.

3. The drape of claim 1 , wherein the first drape portion and the second drape portion are formed as a unit.

4. The drape of claim 1 , wherein the first drape portion and the second drape portion are formed as separate sheets.

5. The drape of claim 1 , wherein the first drape portion comprises a removable portion that, when removed or moved, forms the accessible opening.

6. A motor unit for actuating a surgical arm, the motor unit having an access port therein for receiving, loading and assembling the surgical arm, the access port being configured with one or more doors; The drape of claim 1; Equipped with an opening in the cutout of the first drape portion aligned with the access port to expose the access port and one or more doors when the drape is deployed over the motor unit; the second drape portion has a shape and size to substantially cover the access port after assembly into the surgical arm while allowing a distal portion of the assembled surgical arm to protrude outwardly from the motor unit. assembly.

7. The assembly described in claim 6, wherein the opening of the cutout in the first drape portion further exposes an exit aperture of the motor unit located on a front or distal surface of the motor unit, and the distal portion of the received surgical arm protrudes outwardly through the exit aperture.

8. 1. A drape for a surgical device, comprising: a first drape portion in a sleeve-like configuration comprising a thin sheet of flexible material, An open end; a partially closed end opposite the open end; and a tubular body extending between said open end and said partially closed end; a first drape portion defining a a second drape portion configured to be deployed over the first drape portion; Equipped with the first drape portion includes a cutout that forms an accessible opening extending from an edge of the partially closed end to a side edge of the body perpendicular to the edge of the partially closed end when the sleeve is flattened in an unfolded configuration, the cutout having a stepped profile with a recessed corner cutout; the second drape portion is formed from a thin sheet of flexible material, the second drape portion having a shape and size to at least partially cover the accessible opening; drape.

9. 9. An assembly comprising the drape of claim 8 and a surgical device on which the drape is deployed, wherein the cutout in the drape exposes an access port of the surgical device that can receive and attach a device extension, and the cutout further exposes an exit aperture through which a distal portion of the device extension protrudes outside of the surgical device.

10. The assembly of claim 9 , wherein the surgical device comprises a motor unit for actuating one or more surgical arms, and the device extension comprises one or more surgical arms.

Images