Surgical drape for a robotic device

Abstract

Some embodiments relate to a two-part drape for a surgical device, comprising: I. a first drape portion formed from a sheet of flexible material that defines an elongate hollow sleeve, the first drape portion including: an open end on a first side of the sleeve; a partially closed end on a second, opposite side of the sleeve; an elongate sleeve body extending between the open end and the partially closed end; and an access opening extending from the partially closed end to an adjacent portion of the sleeve body; II. a second drape portion configured to be deployed over the first drape portion, the second drape portion being formed from a sheet of flexible material, the shape and dimensions of the second drape portion being designed to at least partially cover the access opening.

Description

[0001] Related Applications

[0002] This application claims priority under 35 USC §119(e) to U.S. Provisional Patent Application No. 62 / 786,452, filed on December 30, 2018, the contents of which are incorporated herein by reference in their entirety.

[0003] Technical field and background of the invention

[0004] The present invention, in some embodiments thereof, 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 to which a distal extension may be assembled.

[0005] US Patent No. 8286637B2 discloses "A surgical radiology C-arm imaging unit drape is provided, which is configured to provide a sterile outer surface around the end of the C-arm imaging unit, and a method of providing a sterile surface around the end of the C-arm imaging unit. The drape includes a flexible shell having an upper wall with a pair of side walls and a rear side extending downwardly from the upper wall. The upper wall and the side walls are extendable between an expanded position and a folded position. When in the expanded position, a pocket is formed below the upper wall with a size that can accommodate the end of the imaging unit. The upper wall has a sterile outer surface, which is configured to face away from the end of the imaging unit and cover the end of the imaging unit to maintain sterility in a sterile field above an operating table. When in the folded position, the sterile outer surface can prevent external contamination." (Abstract) Summary of the invention

[0006] According to one aspect of some embodiments of the present invention, there is provided a two-part surgical drape for use with a surgical device, the drape comprising: I. a first drape portion formed of a thin sheet of flexible material defining an elongated hollow sleeve, the first drape portion comprising: an open end on a first side of the sleeve; a partially closed end on a second opposite 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; II. a second drape portion configured to be disposed on the first drape portion, the second drape portion formed of a thin sheet of flexible material, the second drape portion being shaped and sized to at least partially cover the accessible opening. In some embodiments, the body of the first drape portion comprises at least one fixing component embedded or mounted to the body and located between the accessible opening and the open end. In some embodiments, the fixing component comprises an elongated deformable component. In some embodiments, the body of the first drape portion is closed along a plurality of long edges of the body. In some embodiments, the accessible opening is rectangular. In some embodiments, the second sheet portion includes a processing portion, the processing portion includes a plurality of valley folds, each of the plurality of valley folds is sized to be suitable for inserting at least a portion of a user's hand. In some embodiments, the sheet is made of a continuous or welded plastic or nylon sheet. In some embodiments, the sheet is formed by one or more of: thermoplastic polyurethane, ultra-high molecular weight polyethylene, low-density polyethylene and high-density polyethylene. In some embodiments, the sheet is at least partially transparent to allow at least a portion of the surgical device covered by the sheet to be visible through it. In some embodiments, the first sheet portion includes a mark extending at least around the periphery of the accessible opening. In some embodiments, the mark includes a colored lining. In some embodiments, the first sheet portion includes a pocket or folding portion, and the second sheet portion is stored in the pocket or folding portion and can be pulled away or inserted therein. In some embodiments, the first sheet portion and the second sheet portion are unitarily formed. In some embodiments, the first sheet portion and the second sheet portion are formed with a separate sheet.In some embodiments, one or both of the first sheet portion and the second sheet portion include an attachment device, and the attachment device includes one or more of the following: adhesive, hook and loop fasteners, Velcro, magnets. In some embodiments, one or both of the first sheet portion and the second sheet portion include one or more markings for indicating the direction of applying the sheet portion on the surgical device. In some embodiments, the sheet is formed of a material suitable for sterilization.

[0007] According to an aspect of some embodiments of the present invention, there is provided an assembly comprising: a surgical device comprising a motor unit configured to be attached to one or more surgical arms; and a sheet, wherein the sheet covers the motor unit. In some embodiments, the accessible opening of the first sheet portion exposes an entry port of the motor unit, to which the one or more surgical arms are mounted. In some embodiments, the first sheet portion comprises a fixing assembly mounted or embedded in the first sheet portion, the fixing assembly being positioned to fit over an edge of the motor unit. In some embodiments, the accessible opening exposes at least a portion of a top surface of the motor unit and at least a portion of a front (distal) surface of the motor unit, where exit holes of the one or more surgical arms are located.

[0008] According to one aspect of some embodiments of the present invention, there is provided a surgical equipment drape, the drape comprising: a sleeve made of a thin sheet of flexible material, the sleeve 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 comprising a cutout extending from an edge of the partially closed end to a side edge of the body when the sleeve is laid flat, the side edge being perpendicular to the edge of the partially closed end. In some embodiments, the cutout comprises a stepped profile. In some embodiments, the drape further comprises a fixing assembly aligned along at least a portion of the side edge of the body between the cutout and the open end.

[0009] According to an aspect of some embodiments of the present invention, there is provided an assembly comprising: a drape and a surgical device on which the drape is unfolded, wherein the incision in the drape exposes an access port of the surgical device through which a device extension can be attached. In some embodiments, the fixation assembly is mounted on an edge of the surgical device. In some embodiments, the surgical device comprises a motor unit for actuating one or more surgical arms and the device extension comprises one or more surgical arms.

[0010] According to one aspect of some embodiments of the present invention, there is provided a method for assembling a surgical device while minimizing exposure of the surgical device to the environment, the method comprising: unfolding a sheet on the surgical device to cover the surgical device; removing a first portion of the sheet, the first portion covering an entry port and an exit hole of the surgical device, with at least one surgical arm extending through the entry port and the exit hole; replacing the at least one surgical arm during a surgical operation while keeping at least 90% of the surface area of ​​the surgical device covered by the sheet; and covering the entry port with a second sheet portion.

[0011] According to one aspect of some embodiments of the present invention, there is provided a method for sterile covering of a surgical device having an access port at a distal portion thereof for attachment to a distal device extension, the method comprising: unfolding a drape from a folded state; unfolding the drape onto 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 assembling together a fixing assembly embedded or mounted on the drape opposite the opening so that the fixing assembly conforms to the geometry of the proximal portion of the surgical device. In some embodiments, the opening and the fixing assembly are positioned along the long axis of the drape, and wherein the alignment comprises: aligning at least a segment of the long axis of the drape with the long axis of the surgical device, the opening and the fixing assembly being positioned along at least a segment of the long axis of the drape. In some embodiments, the method further 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 further comprises replacing the distal extension during a surgical procedure by moving the 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.

[0012] According to an aspect of some embodiments of the present invention, there is provided a method for sterile 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; and securing the drape to the surgical device such that the opening remains aligned with the access port, thereby providing consistent access to the access port. In some embodiments, the securing comprises: attaching a securing assembly embedded in or mounted on the drape to the surgical device. In some embodiments, the securing assembly comprises a deformable semi-rigid elongated strip, and the securing comprises: bending the strip over an edge of the surgical device. In some embodiments, the drape comprises a detachable or removable portion covering the opening, and wherein the method comprises: removing or moving the detachable or removable drape portion to expose the access port. In some embodiments, the removing comprises: tearing off the drape portion and the moving comprises: folding the drape portion and rolling up the drape portion to expose one or both of the access port. In some embodiments, the removing or moving is performed no more than 2 minutes before attaching the device extension to the surgical device through the access port.

[0013] According to one aspect of some embodiments of the present invention, there is provided a component comprising: a motor unit for actuating a surgical arm, the motor unit comprising an access port for assembling the surgical arm; and a surgical drape comprising: a drape body comprising an opening, the opening being aligned with the access port when the drape is unfolded onto the motor unit; and a portion of the shape and size being designed to substantially cover the access port after assembling the surgical arm while allowing the assembled surgical arm to protrude outward from the motor unit.

[0014] 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 an access port for assembling a distal extension, the drape comprising: a thin sheet of flexible material, a distal portion of the sheet comprising an opening, the shape and size of the opening being designed to expose the access port; and at least one fixing element (e.g., a deformable strip) embedded or mounted on a proximal portion of the sheet; the fixing element and the opening are respectively aligned along the long axis of the sheet, so that when the fixing element is assembled to the surgical device, the opening remains aligned with the access port. In some embodiments, the opening and the fixing element are positioned relative to each other along the long axis of the sheet. In some embodiments, when the fixing element is assembled to the device, the drape is axially aligned relative to the length of the device. In some embodiments, when the fixing element is assembled to the device, the opening is centered relative to the width of the device. In some embodiments, the fixing element is rigid enough to act as a frame for shaping at least a portion of the drape when deployed on the device. In some embodiments, the fixing element is hard enough to tighten the drape on the device and anchor the drape to the device to prevent the drape from moving. In some embodiments, the fixing element is in the form of a strip comprising a coated flexible wire. In some embodiments, the drape is shaped to cover a box-shaped surgical device. In some embodiments, in the extended state, the drape comprises a rectangular cross-sectional profile including truncated corners defining the opening.

[0015] According to one aspect of some embodiments of the present invention, there is provided a two-part surgical drape for covering a surgical device, the drape comprising: a first drape portion comprising an opening shaped, sized and positioned to expose: an entry port of the surgical device through which a distal extension of the device is assembled; and an exit port from where the distal extension protrudes outward from the device from the exit port; and a second drape portion at least partially disposed on top of the first drape portion after the extension is assembled, the second drape portion being shaped and sized to cover the exposed entry port and define an incision through which the device extension protrudes outward. In some embodiments, the second drape portion comprises a handling portion, the handling portion comprising a valley fold sized to be inserted into at least a portion of a user's hand, the valley fold extending proximal to the exit port and defining the incision when the drape is unfolded. In some embodiments, the drape comprises a flexible strap extending from a proximal face of the second drape portion, the flexible strap being long enough to wrap around the device extension at the exit port to support the extension and around the exit port. In some embodiments, when the first sheet portion is unfolded onto the device, the opening extends from the distal portion of the sheet top surface to the top of the sheet distal side. In some embodiments, the sheet is formed by continuous or welded plastic or nylon sheets. In some embodiments, the sheet is at least partially transparent to allow at least a portion of the device to be visible. In some embodiments, the sheet includes a colored lining for indicating a sterile area. In some embodiments, the first sheet portion includes a pocket or folding portion, in which the second sheet portion is stored and can be pulled away or inserted. In some embodiments, the first and second sheet portions are attached integrally. In some embodiments, the first and second sheet portions are formed by separate sheets.

[0016] According to one aspect of some embodiments of the present invention, there is provided a surgical drape for covering a surgical device, the drape comprising: a first sheet comprising an opening; a second sheet shaped to cover the first sheet, the second sheet covering the opening of the first sheet, thereby reducing the exposure of the portion of the device below the opening to the surrounding environment; one or more adhesives, located on one or both of the first sheet and the second sheet, for bonding the first sheet and the second sheet to each other; and one or more adhesives, located on the first sheet, for connecting the first sheet to the device. In some embodiments, the adhesive comprises one or more of the following: a pull tab, a sticker, a hook and loop fastener, a double lock fastener, and / or an adhesive with an interlocking flat surface. In some embodiments, one or both of the first sheet and the second sheet include one or more markings for indicating the direction of deployment of the sheet on the device. In some embodiments, each sheet comprises a folded and compact configuration. In some embodiments, the cross-sectional area of ​​the compact configuration of each sheet sheet is at least 10 times smaller than the cross-sectional area of ​​each unfolded sheet. In some embodiments, the one or more adhesives are located near the opening.

[0017] According to one 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 portion of a sheet covering an access port through which at least one robotic arm is received; replacing at least one robotic arm during operation while keeping at least 90% of the surface area of ​​the device covered by a sterile sheet; and covering the access port with a portion of the sheet.

[0018] According to one aspect of some embodiments of the present invention, a pull-off adhesive for a surgical drape is provided, comprising: an adhesive strip; an elongated release paper comprising a first end attached to the adhesive strip and arranged on the inner side of the drape and a second end extending to the outer side of the drape; wherein the second end is configured to be pulled up to pull the first end away from the adhesive strip, so that the adhesive strip sticks to a device covered by the drape without being directly contacted by a user.

[0019] According to an aspect of some embodiments of the present invention, there is provided a method for sterile covering a surgical device comprising an access port, the method comprising:

[0020] Unfolding a surgical drape from a folded state; unfolding the drape onto a surgical device to cover the surgical device; aligning an opening formed in a distal portion of the drape with an access port; assembling a fixing element (e.g., a plastically deformable strip) embedded in or mounted on a proximal portion of the drape opposite the opening to maintain alignment so that the fixing element conforms to the geometry of the proximal portion of the surgical device. In some embodiments, the opening and the fixing element are positioned along the long axis of the drape, and the alignment includes aligning the long axis of the drape with the long axis of the surgical device. In some embodiments, the method further includes attaching a 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 further includes replacing the distal extension during operation by moving the second drape or drape portion away from the access port, replacing the distal extension, and covering the access port with the second drape or drape portion again.

[0021] According to one aspect of some embodiments of the present invention, a kit is provided, comprising: a motor unit for actuating a robotic arm, the motor unit comprising an access port for assembling the robotic arm; and a surgical drape comprising: a first sheet comprising an opening, the opening being aligned with the access port when the first sheet is unfolded onto the motor unit; and a second sheet comprising a portion shaped and sized to substantially cover the access port after assembly of the robotic arm.

[0022] According to one 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 the distal end of the device for assembling an extension of the device, the drape comprising: a thin sheet of flexible material, the sheet being long enough to extend at least between the distal end of the device and the proximal end of the device; the sheet including an opening, the shape and size of the opening being designed to expose the access port; and at least one fastener embedded in or mounted on the sheet, the fastener being located at a position opposite the opening, the position corresponding to the proximal end of the device; the opening and the fastener being at a distance from each other, the distance corresponding to the distance between the access port and the proximal end of the device, so that when the fastener is mounted to the surgical device, the opening is held and maintained aligned with the access port.

[0023] According to one aspect of some embodiments of the present invention, there is provided a surgical drape for covering a surgical device, the drape comprising: a first sheet comprising an opening; a second sheet formed to cover the first sheet when the first sheet is unfolded to cover the surgical device, the second sheet covering the opening of the first sheet, thereby reducing exposure of the device portion below the opening to the surrounding environment; one or more adhesives on one or both of the outer surface of the first sheet and the inner surface of the second sheet, for bonding the first sheet and the second sheet to each other; and one or more adhesives on the inner surface of the first sheet, for connecting the first sheet to the device.

[0024] According to one aspect of some embodiments of the present invention, there is provided a method for aseptically covering a surgical device including an access port, the method comprising: unfolding a surgical drape from a folded state; unfolding the drape onto the surgical device to cover the surgical device; aligning an opening formed in a distal portion of the drape with the access port; maintaining the alignment by embedding or mounting a fixing element into a proximal portion of the surgical drape opposite the opening so that the fixing element conforms to the geometry of the proximal portion of the surgical device.

[0025] According to one aspect of some embodiments of the present invention, there is provided a peeling adhesive for a surgical drape, comprising: an adhesive strip; an elongated release paper comprising a first end attached to the adhesive strip and arranged on the inner side of the drape, and a second end extending to the outer side of the drape; wherein the second end is configured to be pulled up so as to pull the first end away from the adhesive strip, so that the adhesive strip sticks to a device covered by the drape without being directly contacted by a user.

[0026] Unless otherwise defined, all technical and / or scientific terms used herein are identical with the meanings generally understood by those of ordinary skill in the art to which the present invention belongs. Although methods and materials similar or equivalent to those described herein may be used in the practice or testing of embodiments of the present invention, exemplary methods and / or materials are described below. If a conflict occurs, the patent specification (including definitions) shall prevail. In addition, materials, methods and embodiments are merely illustrative and are not intended to be necessarily limited. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Some embodiments of the present invention are described herein by way of example only and with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is emphasized that the details shown are by way of example and for the purpose of illustrative discussion of embodiments of the present invention. In this regard, the description in conjunction with the drawings will make it clear to those skilled in the art how embodiments of the present invention may be practiced.

[0028] In the attached picture:

[0029] Figure 1 is a flow chart of a method for covering a device including an attachable extension with a surgical drape according to some embodiments;

[0030] Figure 2 schematically illustrates the deployment of a drape including a deformable element (e.g., a semi-rigid strip) and an opening for fitting over an access port of a surgical device according to some embodiments;

[0031] Figure 3 is a flow chart of a method for covering a device including a modular extension with a surgical drape according to some embodiments;

[0032] FIG. 4A to FIG. 4B Schematically illustrates a top surface (4A) and a distal surface (4B) of a device including a distal extension when the device is covered by a sterile drape according to some embodiments;

[0033] Figure 5 is a flow chart of a method for covering a surgical device with a sterile drape comprising two separate sheets, according to some embodiments;

[0034] Figure 6 is a flow chart of a method for intraoperatively replacing a distal device extension while maintaining device sterility according to some embodiments;

[0035] FIG. 7A to FIG. 7B is a device for covering a bottom portion of a surgical device including a distal extension according to some embodiments ( Fig. 7A ) and top ( Figure 7B ) is a schematic diagram of a single sheet of cloth;

[0036] Figure 8is a schematic diagram of a drape adhesive in the form of a pull-off tab according to some embodiments;

[0037] Fig. 9 schematically illustrates a surgical drape including a folded portion according to some embodiments;

[0038] FIG. 10A to FIG. 10B is an image of a bottom sheet of fabric deployed onto a motor unit of a surgical arm according to some embodiments;

[0039] FIG. 11A to FIG. 11B is an image of a top drape sheet deployed onto a motor unit of a surgical arm according to some embodiments;

[0040] Fig.12 is an image of a deformable fabric element in the form of a semi-rigid strip according to some embodiments;

[0041] 13A-13C are images of an extended bottom sheet ( FIG. 13A ), a folded bottom sheet ( FIG. 13B ), and a folded top sheet ( FIG. 13C ), according to some embodiments;

[0042] 14A-14E schematically illustrate a sheet of fabric including a removable or movable portion according to some embodiments;

[0043] FIG. 15A to FIG. 15C is an image of a sheet of fabric including openings shaped and sized to expose inlet and outlet holes of a motor unit according to some embodiments;

[0044] Fig.16 is a flow chart of a method of using a sheet of fabric including a detachable or removable portion according to some embodiments;

[0045] FIG. 17A to FIG. 17D schematically illustrates a drape for covering a surgical device and at least a portion of a base on which the surgical device is mounted, according to some embodiments; and

[0046] Fig.18 is an image of a sheet covering a motor unit while exposing the inlet and outlet holes of the motor unit, according to some embodiments.

[0047] Description of the Specific Embodiments of the Invention

[0048] The present invention, in some embodiments thereof, 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 upon which a distal extension may be assembled.

[0049] Broad aspects of some embodiments of the invention relate to maintaining sterility of a surgical device that includes an access port for attaching a distal device extension. Some embodiments relate to limiting exposure of the access port to maintain sterility. Some embodiments relate to positioning a surgical drape on the device in such a way that a distal extension, such as a robotic arm (e.g., a surgical robot arm), can be modified (e.g., removed, attached, or replaced) even during a procedure by minimizing exposure of the device area not covered by the drape. Some embodiments relate to minimizing exposure of the portion of the device not covered by the drape to a sterile environment, such as in an operating room.

[0050] One aspect of some embodiments of the present invention relates to a surgical drape, which includes at least one fixture, such as a fixture, such as a deformable or flexible element, positioned to align or maintain the alignment of the drape relative to the device so that the opening defined in the drape is aligned with the entry port of the device. In some embodiments, the fixture and the opening are aligned respectively, such as along the long axis of the drape. Optionally, the fixture and the opening are located at axially opposite portions of the drape. In some embodiments, the opening is defined in a drape portion corresponding to the distal end of the surgical device, and the fixture is located in a drape portion corresponding to the proximal end of the surgical device. Optionally, the opening and the fixture are aligned relative to each other and relative to the surgical device on which the drape is unfolded. In some embodiments, the distance between the opening and the fixture corresponds to the length of the surgical device. In the example of a drape for covering a motor unit of one or more surgical arms, the opening in the drape is positioned so that it is aligned with the entry port through which the surgical arm is connected, and the position of the fixture is such that it can be bent or otherwise mounted on the proximal end of the motor unit, such as bending on a corner or edge connecting the upper surface of the motor unit and the back of the motor unit.

[0051] 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 the surface area of ​​the access port, or optionally is greater than the surface area of ​​the access port. In some embodiments, the opening includes a seam around its border, optionally matching the location of the access port border of the surgical device.

[0052] In certain embodiments, the fixing element is deformable and / or flexible so that it can be assembled or bent to meet the geometry of the surgical device or a part thereof, for example, bend over a corner of a surgical instrument. Alternatively, the fixing element is non-rigid or semi-rigid. Alternatively, the fixing element is plastically deformable. In certain embodiments, the fixing element fixes the sheet to the equipment, and an opening is set so that it overlaps the entrance port completely. In certain embodiments, the sheet covers the equipment and surrounds all equipment parts except the entrance port and optionally the exit port, and the distal extension protrudes outwards from the exit port. In certain embodiments, the fixing element is formed by sufficiently rigid material to fix the sheet to the equipment and keep the sheet in place, but is sufficiently flexible to be bent by the user's finger. In one example, the rigidity range of the fixing element is between 1N / m and 10N / m, for example 3N / m, 5N / m, 7N / m or intermediate, higher or smaller values.

[0053] In certain embodiments, the fixing element tightens the sheet on the device, stretching the opening through the access port. In certain embodiments, the fixing element helps the user by indicating the desired position or orientation during the deployment of the sheet. In certain embodiments, the fixing element is flexible enough to fold over the device corner and / or fit within or on the specified groove or mark formed on the device. In certain embodiments, the fixing element is used as a framework for shaping at least a portion of the sheet when deployed on the device. In certain embodiments, the fixing element anchors the sheet to the device to reduce or prevent the movement of the sheet while keeping entering the access port through the sheet opening.

[0054] Optionally, the fixing element is shaped during use or reshaped in some embodiments. Optionally, the fixing element is installed in a specified device position. In some examples, the fixing element is optionally folded, stretched, twisted and / or otherwise manipulated during use (e.g., during covering the device) to conform to the shape of the device. The fixing element can be a rigid or semi-rigid strip, a clip, a rope, a magnet, a hook and loop fastener (e.g., Velcro) and / or can be flexed or bent to match the form of other elements of the device. Optionally, the fixing element in the form of a strip includes a metal element, such as a metal wire, which in some embodiments is coated with a plastic lining. Optionally, the fixing element is embedded in the sheet forming the cloth sheet. Or, the fixing element is installed on the sheet.

[0055] One aspect of some embodiments of the present invention relates to a surgical drape designed to provide for the attachment, removal, or replacement of a device extension while limiting exposure of portions of the device not directly related to assembly of the extension, thereby reducing exposure of the device to the sterile operating environment and protecting the device from contamination (e.g., from contaminated fluids).

[0056] One aspect of some embodiments relates to a sheet comprising a first portion and a second portion, the first portion comprising an opening shaped and sized to cover an access port of a device, and the second portion comprising a cover that overlaps the opening, e.g., after loading of a device extension. In some embodiments, replacement or removal of the device extension (after initial loading of the extension) can be performed by removing, lifting, pushing aside, and / or otherwise moving the cover away from the sheet opening to expose the access port.

[0057] In some embodiments, the sheet comprises two separate sheets. Optionally, the first sheet comprises an opening and the second sheet comprises a cover. Alternatively, a single sheet is provided, comprising a detachable cover portion or an integrated pocket or fold, in which the cover is accommodated and can be pulled out and compressed therein.

[0058] In some embodiments, the sheet is provided with a tear-off piece that can be removed or moved (e.g., folded or rolled) to form an opening in the sheet. Optionally, in use, the sheet is covered on the surgical device, and the tear-off piece is opened or removed to expose the access port only when the distal extension is installed or assembled near or through the access port. In some embodiments, the sheet is manufactured and packaged, and the tear-off piece is integrally attached to the rest of the sheet. During use, the user (e.g., nurse, doctor, technician) removes or moves the tear-off piece, such as by pulling the tear-off piece to separate along the dotted cut line bordering the tear-off piece. As a supplement or alternative to the tear-off piece, a cover is provided, the shape and / or size of the cover at least partially overlaps with the opening, exposing the access port through the opening. During use, the user can separate, roll up, push the cover aside and / or otherwise move the cover to expose the access port. The potential advantages of exposing the access port only when the distal extension is assembled to the surgical device or near it may include: reducing and optionally minimizing the exposure of the device to the environment, potentially contributing to sterility maintenance.

[0059] Potential advantages of a removable or movable drape portion may include the portion of the device covered by the drape portion, such as an access port, remaining covered until the step of connecting a device extension (such as one or more surgical arms) through the access port.

[0060] In some embodiments, when the sheet is unfolded, the distal side of the sheet is shaped to expose an exit aperture from which the distal device extension protrudes. In some embodiments, the sheet is formed with opposing valley folds that define a cutout portion between them that exposes the exit aperture when unfolded. In some embodiments, the valley folds further serve as an operating portion such that, when unfolded, a user places their hand within the valley folds and pulls the sheet onto the device.

[0061] In some embodiments, the sheet includes a flexible strap extending from the far side of the sheet and long enough to wrap around the device extension at the location of the exit hole. In some embodiments, the flexible strap supports the device extension and helps to keep it in place. In some embodiments, the flexible strap covers any remaining exposed area around the exit hole, thereby potentially reducing the risk of contamination.

[0062] The potential advantages of a surgical sheet configured to provide limited exposure of the entrance and exit holes of the distal extension can include maintaining sterility in an operating room environment, even when the extension is modified (assembled, removed or replaced). Optionally, at least 85%, 95%, 99% or an intermediate, higher or lower percentage of the outer surface area of ​​the device is always kept covered by a sheet. Optionally, no more than 15%, 20%, 5%, 30% or an intermediate, higher or lower percentage of the outer surface of the device is covered by a sheet. In some cases, the device itself (e.g., a motor unit driving one or more surgical arms) is not sterile, and therefore needs to be covered to maintain the sterility of the surrounding operating room environment. Optionally, one or more surgical arms attached to the motor unit are sterile, so that they can be used to perform surgery in a patient. In the case where the arm is not sterile, the arm may also be covered by a protective cover.

[0063] In some embodiments, the sheet includes one or more attachment devices, such as stickers, peel-off tabs, hook-and-loop fasteners, double-lock fasteners, fasteners including interlocking surfaces, and / or other suitable devices for attaching the sheet to the device and / or for attaching sheet portions to each other. In some embodiments, the location of one or more attachment devices is selected to help position (e.g., align or orient the sheet relative to the device) during deployment. In some embodiments, the location of one or more attachment devices is selected in an area that is easily exposed to and / or easily accessible to contaminants, for example, one or more adhesives can be located around the borders of an opening formed in the sheet to reduce the possibility of contaminants entering between the sheet and the device.

[0064] In some embodiments, the surgical sheet is shaped and / or sized to at least partially cover the base on which the surgical device is mounted. In one example, the sheet is large enough to cover the motor unit and the movable cart on which the motor unit is mounted. In some embodiments, the sheet includes a cut, tear-off portion and / or other movable or removable portion that provides for wrapping or otherwise placing the sheet on a base, which in some cases has a size much larger than the surgical device itself. In some embodiments, the sheet is placed above the base in a manner that provides an electrical connection (e.g., a cable) and / or a handle of the base protrudes through the sheet or through an opening in the sheet.

[0065] An aspect of some embodiments relates to an adhesive attachment in the form of a pull-off tab, which is constructed to adhere adhesive strips without aseptic conditions. In certain embodiments, the pull-off tab includes an elongated release paper that curls from the inside (the side facing the device) of the sheet to the outside of the sheet. The inner end of the release paper is connected to the adhesive strips so that when the outer end is pulled up, the release paper is pulled away from the adhesive strips again, allowing a sterile user to adhere the inner side of the sheet to a non-sterile device. The potential advantages of a structure that does not form direct contact with the adhesive tape may include: keeping sterile while still being able to attach the sheet to the device.

[0066] A surgical device as referred to herein may include an actuation unit of a robotic arm, such as a motor unit to which one or more surgical arms may be attached. Other devices contemplated by the present application may include, for example, a surgical device including one or more extensions, such as a drill and associated motors.

[0067] As referred to herein, an apparatus extension may include a surgical arm, such as a robotic arm, optionally including one or more end effectors (e.g., scissors, graspers, electrosurgical tips, and / or other surgical tools) for performing surgery. In some embodiments, the apparatus extension includes a camera and / or other diagnostic device; a surgical working channel; microsurgical tools, such as tools for infertility surgery; and / or other surgical devices that optionally extend from a non-sterile machine (e.g., a motor unit or a console) into a sterile environment.

[0068] As referred to herein, a "first drape sheet," "first drape portion," "base drape," or "base drape portion" may include a drape that is first unfolded onto a surgical device and includes at least one opening, such as an accessible opening, through which an entry port of the surgical device is exposed when the drape is unfolded. Optionally, the accessible opening in the drape is shaped and sized to further expose an exit port of the surgical device through which an equipment extension (e.g., one or more surgical arms) extends. In some embodiments, the first drape includes at least one securing element, such as a flexible or deformable strip, for securing the drape to the surgical device. In some embodiments, the first drape is sterilized, such as during or after manufacture, such as by an EtO (ethylene oxide) sterilization process and / or other process suitable for reducing or eliminating infectious agents (e.g., bacteria).

[0069] In some embodiments, the first sheet forms a sleeve-like shape (see, e.g., FIG. 13B ) when unfolded from a folded, compact configuration. FIG. 17A to FIG. 17C). In some embodiments, the sleeve includes an open end for applying the drape over the surgical device. In some embodiments, when the drape is applied over the surgical device, the deployment direction is from distal to proximal, from the front side of the device (including the exit hole for the surgical arm) toward the back side of the device. Then, in some embodiments, the edge of the drape is pulled or allowed to flow downward, such as toward the ground.

[0070] In some embodiments, the first drape defines a longitudinal axis that substantially corresponds to (or is parallel to): a longitudinal axis of the surgical device; a transverse (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 bottom of the surgical device and / or to the bottom of a base on which the surgical device resides (e.g., 17A to 17C example).

[0071] In some embodiments, the accessible opening in the first sheet is formed as two different openings. Optionally, the position and / or size of one of the openings corresponds to the position and / or size of the surgical device entry port; the position and / or size of the second opening corresponds to the position and / or size of the surgical device exit port.

[0072] In some embodiments, in a drape comprising a single accessible opening, the accessible opening extends over a portion of a first side (e.g., a top side) of the surgical device to an adjacent, optionally vertical side (e.g., a distal side) of the surgical device when the drape is unfolded.

[0073] As referred to herein, a "second drape sheet," "second drape portion," "covering drape," or "covering drape portion" may include a drape that is unfolded onto a surgical device after a first drape sheet or portion is unfolded. 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 that corresponds to the location of the motor unit entry port and only partially covers (or, in some embodiments, does not cover) a surface area of ​​the accessible opening that corresponds to the location of the motor unit exit port (i.e., the location 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 surface of the surgical device) and only partially covers the opening along an adjacent, optionally vertical side (e.g., the distal side) of the covered surgical device.

[0074] In some embodiments, the second sheet is formed as a sleeve. Optionally, the sleeve has a larger cross-sectional area than the first sheet so that it can be worn over the first sheet, optionally around the first sheet when unfolded. Alternatively, the second sheet is formed as a sheet and / or other shape. Optionally, the shape and size of the second sheet is such that when it is worn or arranged on the first sheet, it can be aligned relative to the first sheet and / or relative to the opening in the first sheet and / or relative to the surgical device.

[0075] In some embodiments, the second drape is sterilized, for example, during or after manufacture, such as by an EtO (ethylene oxide) sterilization process and / or other processes suitable for reducing or eliminating infectious agents (eg, bacteria).

[0076] Potential advantages of a two-part drape (or two separate drapes) over a single-component drape may include minimizing exposure to non-sterile areas of surgical equipment and preventing the need to replace the entire drape when connecting, removing and / or replacing equipment extensions, such as when connecting, removing and / or replacing one or more surgical arms on a (multiple) drape-covered motor unit.

[0077] Before explaining at least one embodiment of the present invention in detail, it should be understood that the present invention is not necessarily limited to the details of the construction and arrangement of the components and / or methods described in the following description and / or illustrated in the drawings and / or embodiments in its application. The present invention can have other embodiments or can be practiced or implemented in various ways.

[0078] Now referring to the accompanying drawings, Figure 1 is a flow chart of a method for covering a device including an attachable extension with a surgical drape, according to some embodiments.

[0079] In order to maintain aseptic condition in the operating room, some surgical equipment and usually the patient itself are covered by a sterile cover. In some cases, protecting the operating room equipment with a sterile cover may reduce the risk of contamination, thereby possibly reducing the risk of infection in the patient. In certain embodiments, during the preparation of the operating room, operating room personnel such as doctors, nurses, technicians and / or other personnel prepare the equipment by sterilizing the equipment and / or placing a protective cloth or other covers on the equipment or its parts. In certain embodiments, a surgical sheet is placed to separate between a sterile area and a non-sterile area and / or parts. In certain embodiments, a surgical sheet is placed to reduce the contact of equipment with potential contaminants (such as biological fluids, etc.).

[0080] In some embodiments, the surgical drape is unfolded (101) from a compressed, folded state to an extended, unfolded state, wherein the drape can be unfolded over a surgical device. In some embodiments, in the extended state, the drape is unfolded into a substantially flat form to cover the surgical device. In some embodiments, the drape in the extended state is shaped and sized to cover the surgical device.

[0081] In one example, the surgical device includes a motor unit of a robotic surgical arm, and the sheet is configured to cover the motor unit while still allowing one or more device extensions, such as a robotic arm, to protrude outward to perform surgery. Potential advantages of this structure may include reducing the need to sterilize the motor unit itself. Another potential advantage may include providing for attaching or detaching one or more robotic arms to the motor unit while the motor unit remains substantially sterile and covered by the sheet. In some embodiments, the device extension (e.g., a robotic arm) is sterilized prior to use. Additionally or alternatively, the device extension is also covered or inserted into a sterile sheath. Optionally, the sheath is removed before the extension is introduced into the patient's body.

[0082] In some embodiments, the sheet is pulled over the device to cover it (103). Optionally, when unfolded, the sheet covers a majority of the exposed surface area of ​​the device, such as at least the top and side surfaces of the device. In the example of a box-shaped motor unit, the sheet in a flat extended state (before being placed on the motor unit) includes a rectangular cross-section so that when it is deployed on the motor unit, it covers the top and sides of the box-shaped motor unit and covers the motor unit so that the free end of the sheet hangs above the edge of the motor unit. In some embodiments, the sheet is sized to cover at least 80%, at least 85%, at least 90%, at least 95% or an intermediate, higher or smaller percentage of the outer surface area of ​​the motor unit. In some embodiments, the user guides and aligns the sheet during the unfolding process, such as so that the opening of the sheet overlaps the device entrance.

[0083] In some embodiments, after the initial placement of the sheet on the device (e.g., motor unit), it may be necessary to further adjust the position of the sheet relative to the device. In some embodiments, the sheet is stretched over the device, centered relative to the device, aligned axially relative to the device, and / or otherwise adjusted or repositioned to fit the device closely (one may refer to this as being similar to placing a tablecloth on a table). Thus, in some embodiments, the sheet includes one or more elements for facilitating alignment of the sheet relative to the device and / or attachment of the sheet to the device to hold the sheet in a fixed position.

[0084] In one example, a fixing element in the form of a deformable semi-rigid strip is provided. In some embodiments, the semi-rigid strip is embedded in the sheet, or alternatively, the strip is mounted to the sheet. In one example, the semi-rigid strip comprises a coated flexible wire.

[0085] In some embodiments, after the drape is initially deployed onto the device, the user mounts a securing element onto the surgical device, e.g., pinching a semi-rigid strip onto a designated area of ​​the device, thereby aligning or maintaining alignment of different portions of the drape relative to the device, e.g., an opening formed in the drape having an access port through which one or more device extensions (105) can be attached. In some embodiments, a designated area of ​​the device (e.g., a motor unit) to which the semi-rigid strip is attached includes a special shape, indication, or marking to facilitate placement of the strip. For example, the location can be indicated by a notch, an elongated slot into which the strip can be inserted, a color marking, a protrusion, a corner around which the strip can be folded, and / or other structures and / or other structures and / or visible features to indicate the location for attaching the strip.

[0086] Figure 2 Schematically depicted is the deployment of a drape including a deformable element (eg, a semi-rigid strip) and an opening for fitting over an access port of a surgical device, according to some embodiments.

[0087] In certain embodiments, the single 201 is formed by disposable, transparent, flexible, tear-resistant materials, such as plastics, nylon and / or some textile materials. In certain embodiments, the single is formed by one or more of thermoplastic polyurethane, ultra-high molecular weight polyethylene, low-density polyethylene and / or high-density polyethylene. Optionally, the single comprises a sheet of welding or stitching.

[0088] In some embodiments, the sheet 201 includes a semi-rigid strip 203. Optionally, the strip 203 is mounted or embedded in the proximal portion 205 of the sheet. In some embodiments, the strip 203 extends along the central long axis 207 of the sheet, for example, along 1 / 10, 1 / 8, 1 / 5, 1 / 3, 1 / 4 of the total length of the axis 207. The strip 203 can extend from the closest point of the axis 207, or in some embodiments, from a point further along this axis.

[0089] In some embodiments, the sheet 201 is formed with an opening 209. In some embodiments, the opening 209 is formed at the distal portion 211 of the sheet. In some embodiments, the shape and / or size of the opening 209 is designed so that when the sheet 201 is positioned to cover the device 213, the opening overlaps the entry port 215 of the device 213, and one or more device extensions 217 can be connected through the entry port 215. In some embodiments, the opening 209 is formed along the central long axis 207. Optionally, the opening 209 is rectangular. The application also contemplates openings of other shapes, such as circular, triangular, square or any shape.

[0090] In some embodiments, the opening 209 and the semi-rigid strip 203 are linearly aligned relative to each other. Other embodiments may include different relative positions of the opening and the semi-rigid strip. Optionally, the opening and the semi-rigid strip are positioned relative to each other, such as at either end of the cloth sheet relative to each other.

[0091] In some embodiments, when the sheet 201 is positioned on the device 213, the semi-rigid strip 203 is clamped, folded, and / or otherwise temporarily secured to the device 213. In the example shown herein, the strip 203 is folded over the top corner of the device facing the proximal side, thereby aligning the opening 209 with the access port 215. In some embodiments, attaching the strip to the device (e.g., by folding over a corner, inserting into a designated slot, and / or other attachment methods) stretches the sheet so that it fits at least tightly onto the top surface of the device. In some embodiments, attaching the strip to the device centers the sheet relative to the device, e.g., relative to an axis 217 extending along the wide dimension of the top surface of the device.

[0092] In some embodiments, the semi-rigid strips are configured to plastically deform during attachment. In some embodiments, the strips deform to conform to the shape of the external device housing, such as folding to conform to the angle of the corner 221 of the device. Optionally, deforming the strips changes the planar arrangement of the sheet. Optionally, the semi-rigid strips help maintain the new planar arrangement presented by the sheet by supporting portions of the sheet, such as portions of the sheet facing different directions after the strips are deformed.

[0093] In some embodiments, the lining 219 of the opening 209 of the drape comprises one or more deformable elements, such as semi-rigid strips. Optionally, the lining provides a support frame for the opening, which can help place the opening in a position overlapping the access port 215 of the device.

[0094] In some embodiments, opening 209 is shaped and / or positioned such that one or more device extensions 217 , such as surgical arms, are permitted to extend from access port 215 in a distal direction.

[0095] Alternative embodiments may include a sheet that includes an opening at a proximal portion of the sheet, such as facing in a proximal direction; such an arrangement may be useful for devices in which an access port for receiving a device extension is located on the proximal face of the device (e.g., surgical arm insertion of a motor device is performed from the proximal face of the device). Other embodiments may include openings located at different locations, such as along the side of the unfolded sheet. Some embodiments may not include an opening. Optionally, a portion of the sheet may be simply lifted or otherwise pushed aside to allow access to the access port.

[0096] In some embodiments, the sheet includes two openings, a first opening aligned with an entry port on a top surface of a surgical device, and a second opening aligned with an exit port of the surgical device through which one or more surgical arms extend. Optionally, the exit port is positioned on a forward (distal) facing surface of the surgical device. Alternatively, the single opening of the sheet is shaped and sized to expose the entry port and exit port of the surgical device, optionally covering an adjacent (optionally vertical) surface of the surgical device.

[0097] Figure 3 is a flow chart of a method for covering a device including modular extensions with a surgical drape, according to some embodiments.

[0098] In some embodiments, the sheet is unfolded from a compact folded configuration (301). The unfolded sheet is then covered over the device (303). Optionally, the unfolding of the sheet is assisted by one or more markings, openings, fasteners, plastically deformable elements, and / or other components embedded and / or mounted on the sheet. Additionally or alternatively, the unfolding of the sheet is assisted by one or more markings, openings, protruding structures, indentations, and / or other components of the covered device.

[0099] In some embodiments, the sheet is positioned above the device and oriented so that an opening formed in the sheet is aligned with an access port of the device through which one or more device extensions can be attached. In some embodiments, once the opening overlaps the access port, the device extensions are loaded onto the device (305). In one example, the surgical arm is loaded through one or more doors configured at the access port.

[0100] In some embodiments, optionally after loading the surgical arm, the entry port is at least partially covered with a sheet portion (307). In some embodiments, the opening in the sheet that has been assembled to the device is covered by the sheet portion so that at least 95%, 90%, 85% or an intermediate, higher or lesser percentage of the surface area of ​​the opening is covered by the sheet portion. In some embodiments, the shape and size of the sheet or sheet portion that at least partially covers the opening defined in the initially deployed sheet is designed to cover 50%-80%, 60%-90%, 70%-95% or an intermediate, higher or lower range of the surface area defined by the opening in the initially deployed sheet. In some embodiments, the shape, size and / or positioning of the covering sheet portion is such that it covers the entry port of the surgical device, but only partially covers or does not cover the exit hole of the surgical device, through which a distal device extension (e.g., one or more surgical arms) can extend.

[0101] In some embodiments, an integrated sheet is provided, comprising 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 tearing off an attachment.

[0102] In some embodiments, the second portion is packaged in a folded state and is unfolded only when needed to cover an exposed device area, such as after loading a surgical arm onto the device. Optionally, the folded portion is retained in a designated pocket or fold created in the first portion. In some embodiments, the second portion can be pushed away from the port, such as to allow access to the access port (e.g., for removal or replacement of a device extension). Optionally, the portion pushed aside is grasped by a clip, adhesive means, and / or other attachment to the device. Grasping the portion pushed aside to prevent it from contacting the surrounding environment may help maintain its sterility.

[0103] Additionally or alternatively, the second portion may be torn off (and optionally discarded) when removing or replacing the device extension.

[0104] Alternatively, the sheet is composed of two separate sheets, a first sheet formed with an opening, and a second sheet shaped and sized to substantially cover the area of ​​the device exposed by the opening. In some embodiments, the second sheet is removed (and optionally disposed of) when the device extension is removed or replaced. Optionally, the first sheet remains in place on the device and the second sheet is replaced with a new sheet.

[0105] Potential advantages of a drape including a movable or removable portion for placement over the entry and / or exit ports may include being able to attach, remove, or replace device extensions while reducing exposure of the device, even during surgery.

[0106] In some embodiments, the second sheet includes more than one portion, for example, a first portion covering the top surface of the motor unit (e.g., when the motor unit is covered by the first sheet) and a second portion covering the front (i.e., distally facing) surface of the motor unit (e.g., when the motor unit is covered by the first sheet). Optionally, the multiple portions constituting the second sheet at least partially overlap each other.

[0107] FIG. 4A to FIG. 4B Schematically illustrates a top surface of a device including a distal extension according to some embodiments ( Figure 4A ) and distal side ( Figure 4B ), which is when the device is covered with a sterile drape.

[0108] In some embodiments, the sheet 401 includes an opening 402 (optionally formed as an incision portion) whose shape and size are designed to expose the entrance of the surgical device (in the example, the motor unit of the robot arm). In some embodiments, the opening when the sheet is unfolded on the device extends from the top surface to the distal side, and the device extension (not shown) extends distally from the distal side. In some embodiments, the device extension is loaded through the entrance, such as through one or more doors 407 located on the top surface, so that it extends from the designated exit hole 409 on the distal side of the device. In some embodiments, the loaded extension is aligned linearly along or parallel to the long axis 411 of the device. In some embodiments, the door 407 is also arranged along or parallel to the long axis 411. Optionally, when the door 407 is closed, the top surface of the device is flat, so that the door does not interfere with the unfolding of the sheet. The potential advantages of a flat surface device may include maximizing the contact area between the device surface and the sheet, thereby minimizing the space between the device and the sheet from contamination factors.

[0109] In some embodiments, the second sheet portion (which may be integrally attached to sheet 401, separable from sheet 401, or formed as an independently separable sheet in some embodiments) substantially covers opening 402 so that the exposed entrance, exit holes, and surrounding areas are protected by the second sheet portion. In some embodiments, the second sheet portion includes relative valley folds 415 in which the user's hands may be placed during deployment. When the second sheet portion is deployed on the device, the valley folds define a curtain-like arrangement that allows the device extension to protrude outwardly through the curtain-like arrangement. In some embodiments, in addition to or in place of the valley folds, the sheet also includes handling devices such as handles, straps, drawstrings, or other devices that facilitate the user to deploy the sheet.

[0110] Figure 5 is a flow chart of a method for covering a surgical device with a sterile drape comprising two separate sheets, according to some embodiments.

[0111] In some embodiments, the drape is comprised of first and second (eg, top and bottom) sheets for deployment over the device prior to loading the distal device extension and after loading the distal device extension.

[0112] In some embodiments, the first sheet portion (in one example, the first sheet sheet) is unfolded from its compacted state and covered on the device (501, 503). Optionally, the sheet is formed as a sleeve including an open bottom so that it can be covered on the device and pulled in the direction of the bottom surface of the device toward the device to cover the device. Optionally, one or more deformable elements (such as semi-rigid strips) are then manipulated by the user to attach the sheet to the device (505) at a preselected device position or alternatively in any manner. In some embodiments, one or more attachment devices such as adhesives are used to further connect and / or align and / or adhere the sheet to the device (507). Once the first sheet portion is in place, the entry port of the device remains exposed to allow loading of the distal device extension (509). After the distal device extension is loaded, the second sheet portion (in one example, the second sheet sheet) is unfolded from its compacted state (511). Optionally, the second sheet portion is attached to the first sheet portion according to one or more orientation marks (513) (optionally, the mark includes an adhesive). Optionally, the mark is located at the designated connection position between the first and second sheet parts. In certain embodiments, when folded, the second sheet part includes a valley fold for placing the user's hand (515), which can help guide the user during deployment, such as by indicating the first sheet part in the direction in which the second sheet part needs to be pulled. Optionally, the second sheet part is pulled distally from the proximal end of the surgical device, optionally along the long dimension of the device, until the valley fold is positioned to extend along at least a portion of the distal side of the device. In certain embodiments, the user then presses in the valley fold to attach the "flap" defined by the fold to the distal side of the device (517). Optionally, the flaps are positioned relative to each other so that they allow the distal device extension to protrude between them. Then, the user removes their hands from the valley fold (519). At this stage, the sheet part deployed provides the sterile separation of the device and its environment.

[0113] Figure 6 is a flow chart of a method for mid-operative replacement of a distal device extension while maintaining device sterility according to some embodiments.

[0114] During a surgical procedure, it may be necessary to remove or replace one or more device extensions, such as surgical arms. Such replacements may be performed to: insert surgical arms of a specific size or configuration; reduce or increase the number of arms used; and / or perform specialized surgical procedures, such as drilling, suturing, suturing tissue, sharp dissection of tissue.

[0115] In some embodiments, the portion of the sheet or a separate sheet covering the exposed device access port and optionally the exit hole of the distal extension is removed (601). Alternatively, the portion of the sheet or a separate sheet is pushed away, folded, and / or otherwise moved from the device access port and / or the exit hole of the device extension. Optionally, the portion pushed aside is stored in a designated pocket formed in the sheet, or otherwise maintained in a compressed or folded state to reduce its contact with the surrounding environment.

[0116] In some embodiments, removal of the drape portion exposes only a minimal surface area of ​​the device, e.g., limited to a door of an access port, to enable removal or replacement of a device extension (603). In some embodiments, only 5%, 10%, 15%, or intermediate, higher, or lower percentages of the total surface area of ​​the device previously covered by the drape are exposed for the process of replacing or removing the device extension. Potential advantages of a surgical drape designed to expose only a selected minimal area of ​​a surgical device may include a higher likelihood of maintaining sterility, e.g., compared to requiring the entire drape to be removed from the device to allow removal or replacement of a device extension.

[0117] Replacing one or more device extensions, such as one or more surgical arms, can be performed by opening a door to the access port, lifting the arm from the device, inserting the new arm into the open door, and then closing the door to lock the arm in place.

[0118] In some embodiments, once the device extension is modified (e.g., removed, replaced, or added to a surgical arm), the exposed device area is again partially covered with a sheet. In some embodiments, a new sheet can be deployed on the device. Additionally or alternatively, the previously stored sheet portion is replaced on the exposed device area (e.g., access port) (605).

[0119] FIG. 7A to FIG. 7B is a device for covering a bottom portion of a surgical device including a distal extension according to some embodiments ( Fig. 7A ) and top ( Figure 7B ) Schematic diagram of a single sheet of cloth.

[0120] Fig. 7AThe exemplary bottom single sheet material is shown in cross section.Opening 701 (for example, the cutout portion of the single sheet material) is formed at the top far corner of the single sheet.In certain embodiments, opening 701 forms an angle α with respect to the major axis 703 of the single sheet, and its scope is for example between 1-30 degree, for example 5 degree, 10 degree, 20 degree or middle, larger or smaller angle.In certain embodiments, the angle β formed with respect to axis 705 and extending along the height dimension of the bottom single sheet ranges for example between 60-90 degree, for example 70 degree, 80 degree, 85 degree or middle, higher or smaller angle.Opening 701 is large enough to expose the top surface and / or the selected area of ​​the distal side of the surgical device when deployed, for example, the outlet hole of the distal extension on the entrance port on the top surface of the equipment and the distal side of the equipment.

[0121] In some embodiments, one or more adhesives, such as pull-off tabs 707, are positioned along the far side of the bottom sheet, optionally directly below the opening 701. In some embodiments, the pull-off tab is positioned to attach the bottom sheet to the device at a position directly below the outlet hole of the extension. Another pull-off tab 711 can be positioned on the top surface of the curtain sheet, adjacent to the opening 701. The adhesive such as the pull-off tab positioned adjacent to the boundary of the sheet opening can ensure the adhesion of the sheet at a position where contamination factors may enter. Additional adhesives, such as hook-and-loop connectors 709 (e.g., Velcro attachments) can be arranged at different positions along the sheet. The bottom sheet can be included on the inner surface of the sheet facing the device and / or on the outer surface of the sheet with an attachment device (e.g., adhesive), for example, for attachment to the top sheet.

[0122] In some embodiments, the bottom drape includes a deformable element, such as a semi-rigid strip 713 (e.g., as described above). Optionally, the bendable strip is positioned along the long axis 703. Optionally, the strip 713 is close to the proximal side of the drape so that it can bend at the top proximal device corner when deployed, thereby potentially helping to orient and center the opening 701.

[0123] Exemplary dimensions of the bottom sheet when extended may include: a length (measured along axis 703) such as 2m, 2.5m, 3m or intermediate, larger or smaller sizes, and a height (measured along axis 705) such as 70cm, 80cm, 60cm or intermediate, larger or smaller sizes.

[0124] In the compacted, folded state of the bottom sheet (not shown here), the dimensions may include: for example, a length of 250 cm, 200 cm, 300 cm or intermediate, greater or less (measured along axis 703), and a height (measured along axis 705), for example, 70 cm, 80 cm, 60 cm or intermediate, greater or less.

[0125] Figure 7B The exemplary top sheet material of is shown in the stretched out state. In some embodiments, the top sheet material includes a set of relative valley folds 715, for example, arranged along the far side of the extended sheet. Optionally, during deployment on the device, the user places their hands in the valley folds to pull the top sheet onto the bottom sheet. Potential advantages of the valley folds designed for the placement of the user's hands may include: facilitating the deployment of the top sheet, reducing unnecessary contact between the user and the sheet, and helping to guide and orient the sheet onto the device during deployment.

[0126] In some embodiments, an adhesive such as a hook and loop attachment 709 is positioned on the inside of the valley folds, which face the distal side of the device when the sheet is unfolded. In some embodiments, the adhesive of the top sheet is positioned to attach to an exposed surface area of ​​the device itself. Additionally or alternatively, the adhesive of the top sheet is positioned to attach to the outside of the bottom sheet.

[0127] In some embodiments, the top sheet includes one or more deformable elements, such as semi-rigid straps 717. Optionally, straps 717 are positioned to overlap straps 713 of the bottom sheet when deployed. This can help guide the top sheet to the final deployed position.

[0128] In some embodiments, the top sheet includes a flexible strap 719, such as formed of nylon, extending outwardly from the distal side of the sheet. In some embodiments, the strap 719 is long enough so that when the top sheet is unfolded, the strap can wrap around the exit hole of the device extension. By rolling the strap 719 around the exit hole and optionally around the axis of the device extension, the strap can help: 1. support and anchor the device extension at the exit hole; and 2. reduce the exposed surface area around the exit hole.

[0129] In some embodiments, the dimensions of the top cover may include: a length measured along axis 721, for example, 400 cm, 500 cm, 750 cm, or intermediate, larger or smaller dimensions; and a width measured along axis 723, for example, 200 cm, 250 cm, 350 cm, or intermediate, larger or smaller dimensions.

[0130] Exemplary dimensions of the folded top sheet may include, for example, a length measured along axis 721, such as 200 cm, 213 cm, 250 cm, or intermediate, larger or smaller dimensions; and a width measured along axis 723, such as 145 cm, 120 cm, 160 cm, or intermediate, larger or smaller dimensions.

[0131] In some embodiments, the bottom sheet is large enough to cover the motor unit and further extends to cover the fixation arms that hold the motor unit to the operating table.

[0132] In some embodiments, the top sheet is at least large enough to completely cover the opening of the bottom sheet.

[0133] In some embodiments, the top and / or bottom drape sheets in the folded, compact state include indications (optionally including adhesive, folds, and / or color markings) for indicating the direction of deployment and / or deployment on the device.

[0134] Figure 8 is a schematic diagram of a drape adhesive in the form of a peel tab 801 according to some embodiments.

[0135] In some embodiments, the peeling tongue is configured to allow the user to pull away the release paper 803 to expose the adhesive strip 805 without including sterility. In use, the user pulls the release paper 803 from the sterile side 807 (relative to the sheet 808, i.e., on the outside of the sheet), and the release paper 803 is curled to the non-sterile side 809 of the sheet. The release paper ends at the adhesive strip 807, so that due to the loop form of the release paper, the release paper can be pulled away from the adhesive strip without directly contacting the adhesive strip. When the adhesive strip is exposed, it can be pushed against the device surface (or against a different sheet portion) to attach the sheet 808.

[0136] Other attachment means may include stickers, clips, zippers, snaps, dual locking fasteners (eg, hook and loop fasteners), fasteners including flat interlocking fastener surfaces, and / or others.

[0137] Fig. 9 A surgical drape including a folded portion is schematically illustrated according to some embodiments.

[0138] In certain embodiments, folded single sheet portion 901 is configured in a designated pocket or fold 903 formed in single sheet material 905. Optionally, during use, single sheet material 905 is deployed on surgical equipment so that opening 907 of single sheet material exposes the entrance port and optionally the exit hole of distal device extension for attaching distal device extension. During initial deployment, part 901 can be stored, and after the loading of device extension, part 901 can be pulled or unfolded to cover the exposed equipment area. Optionally, part 901 comprises one or more adhesives for attachment to the selected position of equipment surface and / or single sheet material 905.

[0139] FIG. 10A to FIG. 10B is an image of a bottom sheet of fabric deployed onto a motor unit of a surgical arm, according to some embodiments.

[0140] Fig. 10Ais an image of the distal surface of the motor unit 1001 , from which the surgical arm 1003 extends outward in the distal direction. Fig. 10B is a side view image of the motor unit. As can be observed, in some embodiments, the bottom sheet 1005 is disposed on the motor unit such that an opening formed in the sheet exposes an entry port including a loading door 1007 for connecting the arm 1003, further exposing an exit hole 1009 from which the arm extends outward. In the example, a set of stickers 1011 are located near the exit hole 1009 on opposite sides of the exit hole and can be attached to the motor unit surface when the marked tongue 1013 is pulled. In some embodiments, one or more arrows 1031 (or other directional markings) indicate the direction in which the sticker is pulled.

[0141] In an exemplary embodiment, the dimensions of the cutout portion at the distal device face include a width 1015 of between 5 cm, 10 cm, or 15 cm, or intermediate, larger, or smaller dimensions, for example, to allow installation of a drape directly from below and near the exit hole 1009.

[0142] In some embodiments, the bottom sheet includes colored lines marking the limits of the sterile field 1019. Exemplary dimensions of the sterile field, viewed from one side of the motor unit, may include a length 1021 of 300 cm, 250 cm, 400 cm, or intermediate, larger, or smaller dimensions, and a height 1023 of 15 cm, 20 cm, or 25 cm, or intermediate, larger, or smaller dimensions.

[0143] FIG. 11A to FIG. 11B is an image of a top surgical drape deployed onto a motor unit of a surgical arm, according to some embodiments. Fig.11A The front view of FIG. 1 shows a top sheet 1101 covering a motor unit 1103 with a pair of surgical arms 1105 extending distally from the motor unit 1103. In some embodiments, the top sheet includes valley pleats 1107 sized to place a user's hand on the motor unit during deployment. Optionally, in the final deployed position, the valley pleats 1107 extend along the distal side of the motor unit on opposite sides of the exit hole from which the surgical arms extend.

[0144] Fig. 11B is a side view of the covered motor unit. In some embodiments, the top drape includes a liner 1109 for indicating a sterile field.

[0145] In some embodiments, the top sheet 1101 includes at least two parts: a first part (in Fig. 11B 1113 in the figure), which is shaped and / or sized to cover at least the inlet 1111 exposed by the opening in the bottom sheet; and a second portion (in Fig.11A1115), which is shaped and / or sized to extend along the front (distal) surface of the motor while still exposing the exit hole 1117 of the motor unit, through which one or more surgical arms 1105 can protrude.

[0146] Fig.12 is an image of a deformable sheeting element in the form of a semi-rigid strip 1201 according to some embodiments. In some embodiments, the semi-rigid strip comprises a thread coated with a plastic coating. Optionally, the strip is embedded within the sheeting material. Alternatively, the strip is mounted to the sheeting.

[0147] 13A-13C are images of an extended bottom sheet (when not deployed on a motor unit) (FIG. 13A), a folded bottom sheet (FIG. 13B), and a folded top sheet (FIG. 13C) according to some embodiments. In some embodiments, the top and / or bottom sheet includes one or more markings, such as arrows 1301, which are visible in the folded and / or extended positions and positioned to help guide the user during sheet unfolding.

[0148] In some embodiments, valley folds 1303 for placing a user's hands are accessible in the folded configuration of the sheet.

[0149] In some embodiments, in the folded and / or unfolded state of the sheet, stickers 1305 or other indicia that can aid in orientation during unfolding of the sheet are clearly visible.

[0150] In some embodiments, the top and / or bottom sheets include one or more adhesives 1307 for attaching the sheets to the motor device and / or for attaching the top sheet and the bottom sheet to each other.

[0151] In some embodiments, such as shown in FIG. 13A , the bottom sheet is sleeve-shaped and includes an open end (the direction of the open end is indicated by 1309; the sheet is shown folded, but when unfolded it may extend further in the direction indicated by 1311). In some embodiments, the partially closed end 1313 of the sleeve is configured opposite the open end. In some embodiments, the body 1315 of the sheet extending between the open end and the partially closed end is tubular and hollow.

[0152] As referred to herein, a "partially closed" end may include a side or edge of a sheet sleeve that is sealed along a portion of its length and open along another portion of its length. Optionally, most of the length is sealed. In some embodiments, in use, the partially closed end of the unfolded sheet covers the distal surface of the surgical device so that the exit hole remains exposed but the rest of the distal surface is covered.

[0153] In some embodiments, an accessible opening 1317 (indicated 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, for example, in this photograph, the accessible opening comprises a stepped profile. In some embodiments, in use, a portion of the accessible opening (e.g., a portion extending along the closed end of the sleeve) covers an exit aperture of a surgical device (e.g., an exit aperture of a motor unit through which one or more surgical arms extend); and a different portion of the accessible opening (e.g., a portion extending along a section of edge 1319) covers an entry aperture of a surgical device.

[0154] It should be noted that the accessible opening may be rectangular, triangular, circular, randomly shaped, and / or have other shapes or contours.

[0155] Potential advantages of a sleeve-shaped drape may include reducing or avoiding the need to tie together or otherwise attach the loose ends of a drape, such as a single-layer flat drape, when the drape is unfolded to cover surgical equipment. In some embodiments mentioned herein, the surgical equipment is narrow and elongated, so the unfolding of the drape over the surgical equipment can be facilitated by using a sleeve-shaped drape. Another potential advantage of a sleeve-shaped drape is that sterile coverage is improved and the equipment is less exposed to the environment (or vice versa) because the free ends of the sleeve do not need or rarely need to be tied together or otherwise connected to each other.

[0156] 14A-14E schematically illustrate a sheet of drape including removable portions that, when removed, form openings in the sheet, according to some embodiments.

[0157] In some embodiments, the drape sheet 1401 includes a removable or movable portion 1403 that defines an opening 1407 in the drape sleeve through which an access port 1431 (see FIG. 14C ) for a surgical device is exposed when removed (or moved). Optionally, portion 1403 is attached to the drape by a tear-off coupling so that, for example, by pulling the portion, it can be separated from the sleeve. Additionally or alternatively, the portion is removably attached to the sheet, for example, by an adhesive, such as by tape, glue, and / or other means.

[0158] Figure 14A schematically shows from a side view that a sheet 1401 is folded along the long axis of the sheet while part 1403 is still attached to the sheet. The seam of the removable / movable part 1403 is indicated by a dotted line. In Figure 14B, according to some embodiments, part 1403 is removed, thereby forming an opening through which the motor unit entrance can be exposed. Figure 14C shows a top view of a sheet when being deployed on a motor unit according to some embodiments. Figure 14D shows a side view of a sheet when being deployed on a motor unit according to some embodiments. Figure 14E shows a front view of a sheet when being deployed on a motor unit according to some embodiments. Optionally, when part 1403 is removed, the exit hole 1405 of the motor unit, such as the exit hole 1405 through which one or more surgical arms extend distally, is exposed.

[0159] In some embodiments, the shape and size of portion 1403 (and therefore the opening 1407 formed when portion 1403 is removed or moved) matches the shape and / or size of the motor unit inlet and outlet holes. Optionally, portion 1403 overlaps the inlet and outlet holes in a cooperative manner so that it does not extend beyond the boundary line of the inlet and outlet holes, exposing only those parts of the motor unit without exposing other parts when removed. Optionally, the surface area of ​​portion 1403 corresponds to the total surface area of ​​the inlet and outlet holes of the motor unit. Optionally, the surface area of ​​portion 1403 is similar to the sum of the surface areas of the inlet and outlet holes. In the example shown, portion 1403 is shaped to have a stepped profile, defining, for example, two steps. Optionally, most of the opening formed by the upper step 1409 is configured to expose the motor unit inlet; and a minority of the opening formed by the lower step 1411 is configured to extend directly below the outlet hole of the motor unit when the sheet is unfolded on the motor unit (e.g., as shown in Figure 14E).

[0160] Alternatively, the shape and / or size of portion 1403 is larger than the inlet and outlet apertures. For example, portion 1403 may be formed with a rectangular side profile, wherein the lower edge of the rectangle extends below the outlet aperture, for example when the sheet is unfolded over the motor unit.

[0161] In some embodiments, such as shown in FIG. 14C , portion 1403 defines an opening through which an access port of a surgical device is exposed, and a fixture 1415 (in one example, a deformable strip) for mounting a drape to a proximal end of the surgical device, located at a distance 1419 of, for example, 10-20 cm from each other, such as 14 cm, 16 cm, 18 cm, or an intermediate distance, longer, or shorter distance from each other, such as measured from the proximal end of portion 1403 to the distal end of fixture 1415. Optionally, portion 1403 and fixture 1415 are positioned relative to each other along an axis, which in some embodiments is a long axis 1417 of the drape. Optionally, portion 1403 and fixture 1415 are centered relative to long axis 1417. In some embodiments, distance 1419 corresponds to the distance between an access port of a surgical device (e.g., a motor unit) and a proximal end of the surgical device (e.g., 100 mm), such as a proximal face of the motor unit.

[0162] It should be noted that in some embodiments, the sheet includes more than one fixing element for fixing the sheet to the motor unit, such as 2, 5, 6, 10 fixing elements or intermediate, larger or smaller numbers. Optionally, different fixing elements are positioned on the sheet at positions corresponding to the edges or corners of the motor unit.

[0163] In some embodiments, such as shown in FIG. 14A , for example, when deployed (and in a non-deployed 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 end allows the walls of the sleeve to be pulled apart from each other so as to wrap the sleeve over the surgical device.

[0164] In some embodiments, the opening defined at portion 1403 extends from an edge of the partially closed end 1453 to an adjacent edge 1455 of the tubular sleeve, which can be substantially perpendicular to the closed end 1453 when in the expanded configuration.

[0165] In some embodiments, the sheet's long axis 1417 extends along edge 1455. In some embodiments, the openings defined at 1403 and the fasteners 1415 are configured along the long axis.

[0166] In some embodiments, during use, for example, Fig.16As described in the flowchart of , after the sheet has been unfolded to cover the motor unit (1601), the user (e.g., nurse, doctor, and / or other operating room staff) separates the removable sheet portion, thereby exposing the motor unit entrance and / or exit hole (1603). Additionally or alternatively, the user moves the sheet portion, such as moving the sheet portion. By rolling it sideways or upward, the portion is pushed aside, and / or otherwise exposes the motor unit entrance. In some embodiments, the removal and / or movement of the sheet portion only occurs close to (e.g., just before) the time when the surgical arm is attached to the motor unit, such as no more than 5 minutes, 2 minutes, 30 seconds, 10 seconds, or an intermediate, longer or shorter time period before the surgical arm is connected to the motor device. The potential advantages of exposing the motor unit entrance port by removing (or moving) the sheet portion only when the surgical arm is attached to the motor unit may include: minimizing the exposure of the non-sterile portion of the surgical device to the sterile environment of the operating room environment. Another potential advantage may include: protecting the motor unit (or its portion) from possible contamination for as long as possible. At 1605, the surgical arm is attached to a motor unit, such as a motor unit. The arm is mounted through an exposed access port of the motor device. At 1607, once the arm is in place, at least a portion of the access port is covered again, such as by a second drape, by a different portion of the drape originally used, and / or by moving or rolling aside to expose the same portion of the access port. Optionally, at the end of the draping process, only the exit port remains uncovered by the drape, thereby allowing the surgical arm to extend therethrough.

[0167] FIG. 15A to FIG. 15C is an image of a sheet including openings shaped and sized to expose the inlet and outlet holes of the motor unit when worn over the motor unit according to some embodiments. Fig.15A As shown, the sheet 1501 defines an opening having a stepped profile. Optionally, the shape, size and positioning of the first step 1503 conform to the entry opening 1505 of the motor unit 1507, such as Fig. 15B and the shape, size and position of the second step 1509 are designed to expose the outlet hole 1511 of the motor unit, such as Fig. 15C As shown, optionally located in front of the motor unit 1507.

[0168] In some embodiments, one or more attachment devices 1513, such as adhesives (such as stickers, peel-off tabs), magnets, hook and loop fasteners and / or other attachment devices, are positioned at one or more locations along the boundaries of the opening in the drape to attach the drape to the motor unit.

[0169] In some embodiments, markings 1515, such as in the form of tape lines, colored lines and / or other types of markings, extend to distinguish the sterile portion of the drape (e.g., when deployed on the motor unit) from the non-sterile portion. In some embodiments, the access port boundary is located within the boundary defined by the markings.

[0170] FIG. 17A to FIG. 17D A drape for covering at least a portion of a surgical device and a base on which the surgical device is mounted is schematically illustrated according to some embodiments.

[0171] In some embodiments, sheet 1701 (see Fig.17D The shape and / or size of the motor unit 1703 (see Fig.17A ), and a base 1705 on which the motor unit is placed or mounted (see Fig.17A ). In some embodiments, the base is movable, such as a rolling cart.

[0172] In some embodiments, the sheet 1701 includes: a first opening 1702 (also referred to as an "accessible opening") for exposing an entry port 1707 of the motor unit; and a second opening 1713 (also referred to as an "expanded opening"), which helps cover the base 1705. In some embodiments, the base 1705 may have a larger size (e.g., a 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% greater than the width 1711 of the motor unit 1703.

[0173] Potential advantages of covering the base with the same drape used to cover the motor unit may include: ease of use, reducing the number of actions the doctor / nurse needs to perform when preparing for surgery, thereby reducing the time spent on preparation, such as using a drape to maintain sterility.

[0174] In some embodiments, the tear-off and / or other removable or movable sheet portion defines a second opening 1713 to facilitate deployment of the sheet 1701 onto the base 1705 (eg, from the top down) when removed.

[0175] In some embodiments, after unfolding the drape 1701, a top drape and / or other drape portions or even a sterile drape is placed on top of the opening 1713. Optionally, for example, Fig. 17B As shown, one or more attachment devices 1715 are located on the sheet 1701, such as an adhesive (e.g., a sticker, optionally double-sided); a clip; a magnet and / or other attachment devices for attaching to an upper sheet or other portion of the covering opening 1713.

[0176] In some embodiments, for example, Fig. 17C As shown, drape 1701 includes a second layer 1717 which can be moved, unfolded, and / or otherwise positioned to cover opening 1713 .

[0177] Fig.17D Shown is an example of a sheet layout comprising a cutout 1719, which allows the sheet portions constructed on its side to be pulled apart from each other to form an opening 1713. In certain embodiments, the cutout 1719 extends along a section of the sheet's major axis. In certain embodiments, the opening 1702 for allowing access to the entry port is configured to be relative to the cutout 1719, such as along the sheet's major axis. In certain embodiments, a fixture 1721, such as a deformable strip, is positioned between the cutout 1719 and the opening 1702.

[0178] Fig.18 is an image of a sheet covering a motor unit while exposing the inlet and outlet holes of the motor unit, according to some embodiments.

[0179] exist Fig.18 In the exemplary assembly shown, a sheet 1801 is shown partially covering a motor unit 1803 mounted on a stand (or base) 1805. In some embodiments, the sheet 1801 is sized to be large enough to cover the stand 1805 along its height. Optionally, the sheet is large enough to extend from the motor unit location to the ground on which the stand is located.

[0180] In some embodiments, the drape 1801 is a sleeve comprising an elongated hollow structure, optionally tubular.

[0181] In some embodiments, the open end 1807 of the unfolded sheet points to the ground. Optionally, the free ends of the open end can be tied together or fastened together.

[0182] In some embodiments, the partially closed end 1809 of the unfolded sheet faces in a distal (forward) direction. Optionally, the direction corresponds to the direction in which one or more surgical arms 1811 extend from the motor unit. In some embodiments, in the non-expanded state, the partially closed end 1809 is configured to be opposite to the open end 1807, and when the sheet is applied to the device, a portion of the sheet is rotated to move the partially closed end to face in a direction substantially perpendicular to the direction facing the open end. In some embodiments, this rotation is the result of aligning the accessible opening of the sheet with the entry port 1815 and / or exit port 1817 of the motor unit 1803.

[0183] The terms "comprises," "comprising," "includes," "including," "having" and their congeners mean "including but not limited to."

[0184] The term "consisting of" means "including and limited to."

[0185] The term "consisting essentially of" means that the composition, method or structure may include other ingredients, steps and / or components, but only if the other ingredients, steps and / or components do not materially change the basic and novel characteristics of the claimed composition, method or structure.

[0186] 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 a plurality of compounds, including mixtures thereof.

[0187] Throughout the 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 only for convenience and brevity, and should not be interpreted as an inflexible limitation on the scope of the present invention. Therefore, the description of the range should be considered to have explicitly disclosed all possible sub-ranges and individual numerical values ​​within the range. For example, the description of the range from 1 to 6 should be considered to have explicitly disclosed sub-ranges from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as individual numbers within the range, such as 1, 2, 3, 4, 5, and 6. This has nothing to do with the breadth of the range.

[0188] Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integer) within the indicated range. The phrases "ranging / ranges between" between a first indicated numeral and a second indicated numeral, and "ranging / ranges from" from a first indicated numeral "to" a second indicated numeral are used interchangeably herein and are intended to include the first and second indicated numerals and all fractions and integers therebetween.

[0189] As used herein, the term "method" refers to manners, means, techniques and procedures for accomplishing a given task, including but not limited to those manners, means, techniques and procedures which are known or which are readily developed from known manners, means, techniques and procedures by practitioners in the fields of chemistry, pharmacology, biology, biochemistry and medicine.

[0190] As used herein, the term "treating" includes abrogating, substantially inhibiting, slowing or reversing the progression of a disorder, substantially ameliorating the clinical or aesthetic symptoms of a disorder or substantially preventing the appearance of clinical or aesthetic symptoms of a disorder.

[0191] It should be understood that certain features of the invention described in the context of separate embodiments for clarity may also be provided in combination in a single embodiment. Conversely, various features of the invention described in the context of a single embodiment for brevity may also be provided individually or in any suitable subcombination or in any other described embodiment of the invention as appropriate. Certain features described in the context of various embodiments should not be considered essential features of those embodiments unless the embodiments cannot function without those elements.

[0192] All publications, patents and patent applications mentioned in this specification are incorporated herein 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 herein by reference. In addition, the citation or identification of any reference in this application should not be construed as an admission that the reference can be used as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.

[0193] In addition, any priority documents of the present application are hereby incorporated by reference in their entirety.

Claims

1. A two-part surgical drape for surgical equipment, Features: The sheet comprises: I. A first sheet portion formed from a thin sheet of flexible material defining an elongated hollow sleeve, the first sheet portion comprising: an open end on a first side of the sleeve; a partially closed end on a second opposing side of the sleeve; an elongated sleeve body extending between said open end and said partially closed end; and an accessible opening extending from the partially closed end to an adjacent portion of the sleeve body; II. A second sheet portion configured to be disposed on the first sheet portion, the second sheet portion being formed of a thin sheet of flexible material, the second sheet portion being shaped and sized to at least partially cover the accessible opening; Wherein the accessible opening in the first drape portion exposes an access port of the surgical device through which a device extension may be attached.

2. The sheet according to claim 1, Features: The body of the first sheet portion includes at least one fixing component embedded in or mounted to the body and located between the accessible opening and the open end.

3. The sheet according to claim 2, Features: The fixing component includes an elongated deformable component.

4. The sheet according to claim 1, Features: The body of the first sheet portion is closed along a plurality of long edges of the body.

5. The sheet according to claim 1, Features: The accessible opening is rectangular.

6. The sheet according to claim 1, Features: The second sheet portion includes a handling portion including a plurality of valley folds, each of the plurality of valley folds being sized for insertion of at least a portion of a user's hand.

7. The sheet according to claim 1, Features: The sheet is made of continuous or welded plastic or nylon sheets.

8. The sheet according to claim 7, Features: The sheet is formed from one or more of: thermoplastic polyurethane, ultra-high molecular weight polyethylene, low density polyethylene, and high density polyethylene.

9. The sheet according to claim 1, Features: The drape is at least partially transparent to allow at least a portion of a surgical device covered by the drape to be visible therethrough.

10. The sheet according to claim 1, Features: The first sheet portion includes indicia extending at least around a perimeter of the accessible opening.

11. The sheet according to claim 10, Features: The indicia includes a colored liner.

12. The sheet according to claim 1, Features: The first sheet part comprises a pocket or a fold in which the second sheet part is stored and can be pulled out or inserted.

13. The sheet according to claim 1, Features: The first sheet portion and the second sheet portion are integrally formed.

14. The sheet according to claim 1, Features: The first sheet portion and the second sheet portion are formed from separate sheets.

15. The sheet according to claim 1, Features: One or both of the first sheet portion and the second sheet portion include an attachment device comprising one or more of: adhesive, hook and loop fastener, Velcro, magnet.

16. The sheet according to claim 1, Features: One or both of the first drape portion and the second drape portion include one or more markings for indicating a direction in which the drape portion is applied to the surgical instrument.

17. The sheet according to claim 1, Features: The sheet is formed from a material suitable for sterilization.

18. The sheet according to claim 1, Features: The first sheet portion includes a detachable portion which, when detached or moved, forms the accessible opening.

19. A component, Features: The components include: A surgical device, including a motor unit, configured to be attached to one or more surgical arms; and A sheet as described in claim 1, wherein the sheet covers the motor unit; wherein the accessible opening of the first sheet portion exposes an entry port of the motor unit, the one or more surgical arms are mounted to the entry port, and the accessible opening exposes at least a portion of the top surface of the motor unit and at least a portion of the distal surface of the motor unit, where exit holes of the one or more surgical arms are located.

20. The assembly of claim 19, Features: The first sheet portion includes a fixing assembly mounted or embedded in the first sheet portion, the fixing assembly being positioned to fit over an edge of the motor unit.

21. A method for sterile covering of a surgical device having an access port at a distal portion thereof for attachment to a distal device extension, Features: The method comprises: unfold the sheet from a folded state; unfolding the drape onto the surgical device to cover the surgical device; aligning an opening formed in a distal portion of the drape with the access port; maintaining said alignment by assembling together a fixation assembly embedded in or mounted on said drape opposite said opening such that said fixation assembly conforms to the geometry of the proximal portion of said surgical device; attaching a distal device extension through the access port; and The access port is covered with a second drape or drape portion such that only the distal device extension protrudes therefrom.

22. The method of claim 21, Features: The opening and the fixing assembly are positioned along the long axis of the drape, and wherein the alignment comprises aligning at least a section of the long axis of the drape with the long axis of the surgical device, the opening and the fixing assembly being positioned along at least a section of the long axis of the drape.

23. The method of claim 21, Features: The method further includes replacing the distal extension during a 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.

24. A method for sterile draping of a surgical device comprising an access port, Features: The method comprises: unfolding a drape including an opening to cover the surgical device while exposing the entry port and the exit port through the opening; securing the drape to the surgical device such that the opening remains aligned with the access port, thereby providing consistent access to the access port; receiving a surgical arm in the access port of the surgical device; and attaching the surgical arm to the surgical device through the access port such that the surgical arm extends through the exit port; and The access port is covered with a second drape or drape portion so that only the surgical arm protrudes therefrom.

25. The method of claim 24, Features: The securing includes attaching a securing component embedded in or mounted on the drape to the surgical device.

26. The method of claim 25, Features: The securing assembly includes a deformable semi-rigid elongated strip, and securing includes bending the strip over an edge of the surgical device.

27. A component, Features: The components include: a motor unit for actuating a surgical arm, the motor unit comprising an access port for assembling the surgical arm; and Surgical drapes, including: a sheet body including an opening that aligns with the access opening when the sheet is unfolded onto the motor unit to expose the access opening and one or more doors; and The shape and size are designed to substantially cover a portion of the access port after assembly of the surgical arm while allowing the assembled surgical arm to protrude outwardly from the motor unit.

Images