Imaging drapes, packaging for drapes, methods of using imaging drapes, and methods of deploying drapes

Abstract

To provide a drape capable of providing a portable imaging environment by reducing or limiting ambient light in fluorescent imaging of a target in a portable imaging environment.SOLUTION: A drape for use with fluorescence-based imaging and white-light imaging includes a drape body 20. The drape body is configured to limit passage of electromagnetic radiation including light through the drape body to an interior imaging environment defined by the drape body such that electromagnetic radiation including ambient light within the interior imaging environment does not exceed a predetermined threshold. The drape also includes a connecting element 50 permanently coupled to the drape body. The connecting element defines a hole in the drape body. The connecting element is configured to attach the drape to a portable, handheld imaging device.SELECTED DRAWING: Figure 9B

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This patent application claims the benefit of priority to U.S. Provisional Application No. 62 / 669,009, filed May 9, 2018, the entire contents of which are incorporated herein by reference.

[0002] Technical Field The present disclosure relates to a drape for providing a portable imaging environment in which ambient light is reduced or limited for fluorescent imaging of targets within the portable imaging environment. The drape may be used with fluorescent-based portable handheld imaging devices. The drape may also be used with white light imaging and / or measurement devices and processes. [Background technology]

[0003] Introduction The section headings herein are for organizational purposes only and should not be construed as limiting the subject matter described in any way.

[0004] Recent technological advances allow clinicians to quickly, safely, and easily visualize and measure bacteria (and other biological components) in wounds at the point of care. This allows for optimal real-time insight into precise treatment choices and accelerated healing. Fluorescence-based imaging allows clinicians to focus on potentially harmful levels of bacteria. This technology is based on the detection and analysis of unique fluorescent signals emitted by tissues and microorganisms (or exogenous materials) when illuminated with specific wavelengths of light. Room lighting can interfere with the fluorescent signals emitted by bacteria in the wound or on other surfaces that the clinician or others are imaging.

[0005] Fluorescence imaging can be enhanced and optimized when imaging is performed in a dark environment or in an environment where ambient light is reduced or limited. This can be difficult to achieve when the imaging environment has ambient light such as sunlight, room lighting, or other (optical) interference from non-visible electromagnetic radiation. Even if it may be possible to change the ambient light by turning off the room lights or drawing shades, doing so may create other problems for clinicians, such as poor visibility. Furthermore, one advantage of portable handheld imaging devices is that they can be used at the point of care, such as in the field treating military, refugees, or other people who need treatment in outdoor situations. In these scenarios, it is not possible to dim the light source or draw shades. Therefore, it would be desirable to create a portable imaging environment that can provide a suitable environment for imaging regardless of location. Summary of the Invention [Means for solving the problem]

[0006] The present disclosure may solve one or more of the problems set forth above and / or demonstrate one or more of the desirable features set forth above. Other features and / or advantages may become apparent from the following specification.

[0007] Various exemplary embodiments of the present disclosure provide a drape, the drape comprising a drape body configured to detect electromagnetic radiation within an internal imaging environment above a predetermined threshold. The drape body is configured to restrict the passage of electromagnetic radiation through the drape body to an interior imaging environment defined by the drape body so as not to exceed a maximum imaging area of ​​the drape body. A connection element is permanently coupled to the drape body and defines an opening in the drape body. The connection element is configured to attach the drape to an imaging device.

[0008] According to another aspect of the disclosure, a system for fluorescence-based imaging of a target is provided. The system includes a drape having a drape body configured to restrict electromagnetic radiation from passing through the drape body to an internal imaging environment defined by the drape body such that electromagnetic radiation in the internal imaging environment does not exceed a predetermined threshold. A connection element is permanently coupled to the drape body and defines an opening in the drape body. The connection element is configured to attach the drape to an imaging device. The system also includes a portable handheld imaging device, the imaging device including a portion having a lens and at least one violet light source, the connection element configured to surround an area surrounding the lens and the at least one light source to align the light source within the interior space of the drape body.

[0009] The portable handheld imaging device may also include a white light source and be configured for white light imaging.

[0010] The imaging target may be a human or animal body part and may include a wound, lesion, cut, incision, tumor, or other abnormality on or within the body part.

[0011] According to a further aspect of the disclosure, the drape comprises a drape body configured to move between a closed configuration and an open configuration. In the closed configuration, the drape body is generally planar, and in the open configuration, the drape body has a generally cylindrical, generally rectangular, truncated cone, or truncated pyramid shape. The connection element is coupled to the drape body and configured to attach the drape to a portable handheld imaging device. The at least one valve is configured to pump air into the drape as the drape moves from the closed configuration to the open configuration.

[0012] According to yet another aspect of the present disclosure, a method of creating a portable imaging environment is disclosed, the method including aligning a portable handheld imaging device with an opening in a light blocking drape while the drape is in a folded state and connecting a frame of the drape to the imaging device, the method also including moving the imaging device and connected drape away from a packaging element supporting the drape in the folded state.

[0013] Another aspect of the disclosure provides a method of acquiring fluorescent-based images or videos without altering ambient light conditions. The method includes removing a cover from an opening of a shaded drape, attaching a portable handheld imaging device to the drape while the drape is connected to a packaging element, and moving the imaging device and attached drape away from the packaging element to unfold the drape. The method also includes aligning an open bottom end of the drape over a body part to be imaged, contouring a portion of the drape around the body part to be imaged to create a shaded imaging environment around the body part to be imaged, the drape being configured to limit the passage of ambient light through the drape and into the shaded imaging environment, and capturing a fluorescent image or video of the body part with the imaging device attached to the drape.

[0014] Yet another aspect of the present disclosure provides a dispensing element configured to store a shade drape. The dispensing element includes a generally flat base portion and at least one restraining element configured to engage a shaping element of the shade drape. It also includes a

[0015] A further aspect of the present disclosure provides a shade drape system. The system includes a shade drape having a drape body configured to restrict ambient light from passing through the drape body to an interior imaging environment defined by the drape body. The shade drape also includes a frame configured to attach the drape to an imaging device and at least one shaping element configured to maintain the drape in a position outside the field of view of the imaging device during imaging. The system also includes a drape dispensing element. The drape dispensing element includes a generally flat base portion and at least one restraining element configured to engage the at least one shaping element of the shade drape.

[0016] According to yet another aspect of the present disclosure, there is provided a method of obtaining measurements of a target without altering ambient light conditions, the method including removing a cover from an opening of a light-shielding drape, attaching an imaging device to the drape while the drape is connected to a packaging element, moving the imaging device and attached drape away from the packaging element and unfolding the drape, the method also including aligning an open bottom end of the drape over a body part including the target to be measured, contouring a portion of the drape around the body part including the target to be imaged to create a light-shielding environment around the body part including the target to be measured, the drape being configured to limit electromagnetic radiation from passing through the drape into the light-shielding environment, and measuring the target on the body part with a portable handheld imaging device attached to the drape.

[0017] Additional objects and advantages will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by the practice of the disclosure. These objects and advantages may be realized and attained by means of the elements and combinations particularly pointed out in the appended claims, and equivalents thereof.

[0018] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the scope of the present disclosure and claims.

[0019] The present disclosure can be understood from the following detailed description alone or in conjunction with the accompanying drawings, which are included to provide a further understanding and are incorporated into and constitute a part of this specification. The drawings illustrate one or more exemplary embodiments of the present disclosure and, together with the description, serve to explain various principles and operations. [Brief description of the drawings]

[0020] [Figure 1] FIG. 1 is a perspective view of an exemplary imaging device capable of fluorescence-based imaging and / or white light imaging and to which a drape according to the present disclosure can be attached or connected. [Diagram 2] 1 is a perspective view illustrating a first exemplary embodiment of a drape in a deployed configuration or expanded state in accordance with the teachings of the present disclosure. [Diagram 3] 1 is a cross-sectional view illustrating a first exemplary embodiment of a drape in a deployed configuration or expanded state in accordance with the teachings of the present disclosure. [Figure 4] 3 is a partial view of the drape of FIG. 2 showing a shaping element embedded in the drape according to the teachings of the present disclosure. [Figure 5A] 1 illustrates a second exemplary embodiment of a drape in a closed, undeployed state according to the present disclosure. [Figure 5B] 1 illustrates a second exemplary embodiment of a drape in a closed, undeployed state according to the present disclosure. [Figure 5C] 1 illustrates a second exemplary embodiment of a drape in an open, deployed state according to the present disclosure. [Figure 6A] 13 illustrates a third exemplary embodiment of a drape according to the present disclosure being used with an imaging device. [Figure 6B]13 illustrates a third exemplary embodiment of a drape according to the present disclosure with the imaging device removed. [Figure 6C] 1 illustrates a third exemplary embodiment of a drape according to the present disclosure in a closed, undeployed state. [Figure 7] FIG. 13 is a perspective view illustrating a fourth exemplary embodiment of a drape used in an imaging device according to the present disclosure. [Figure 8A] 1A-1C illustrate exemplary embodiments of connecting elements of a drape according to the present disclosure. [Figure 8B] 1A-1C illustrate exemplary embodiments of connecting elements of a drape according to the present disclosure. [Figure 8C] 1A-1C illustrate exemplary embodiments of connecting elements of a drape according to the present disclosure. [Figure 8D] 1A-1C illustrate exemplary embodiments of connecting elements of a drape according to the present disclosure. [Figure 8E] 1A-1C illustrate exemplary embodiments of connecting elements of a drape according to the present disclosure. [Figure 8F] 1A-1C illustrate exemplary embodiments of connecting elements of a drape according to the present disclosure. [Figure 8G] 1A-1C illustrate exemplary embodiments of connecting elements of a drape according to the present disclosure. [Figure 8H] 1A-1C illustrate exemplary embodiments of connecting elements of a drape according to the present disclosure. [Figure 8I] 1A-1C illustrate exemplary embodiments of connecting elements of a drape according to the present disclosure. [Figure 9A] 1 illustrates a drape in an undeployed configuration connected to a portable handheld imaging device according to the present disclosure. [Figure 9B] 1 illustrates a drape in a deployed configuration connected to a portable handheld imaging device according to the present disclosure. [Figure 9C] 1 illustrates a drape in a deployed configuration connected to a portable handheld imaging device according to the present disclosure. [Figure 10A] 1 illustrates a dispensing / packaging element of the present disclosure without a drape. [Figure 10B] 1 illustrates a dispensing / packaging element of the present disclosure without a drape. [Figure 10C] 1 illustrates a dispensing / packaging element of the present disclosure without a drape. [Figure 10D] 1 shows a dispensing / packaging element with a drape of the present disclosure. [Figure 10E] 1 shows a dispensing / packaging element with a drape of the present disclosure. [Figure 11A] 1 illustrates an exemplary cover for an opening in a connection element of a drape according to the present disclosure. [Figure 11B] 1 illustrates an exemplary cover for an opening in a connection element of a drape according to the present disclosure. [Figure 11C] 1 illustrates an exemplary cover for an opening in a connection element of a drape according to the present disclosure. [Figure 12A] 13 illustrates a fifth exemplary embodiment of a drape not connected to a portable handheld imaging device according to the present disclosure. [Figure 12B] 13 illustrates a fifth exemplary embodiment of a drape not connected to a portable handheld imaging device according to the present disclosure. [Figure 12C] 13 illustrates a fifth exemplary embodiment of a drape not connected to a portable handheld imaging device according to the present disclosure. [Figure 12D] 13 illustrates a fifth exemplary embodiment of a drape connected to a portable handheld imaging device according to the present disclosure. [Figure 12E] 13 illustrates a fifth exemplary embodiment of a drape connected to a portable handheld imaging device according to the present disclosure. [Figure 12F] 13 illustrates a fifth exemplary embodiment of a drape connected to a portable handheld imaging device according to the present disclosure. [Figure 12G] 12D-12F show an exemplary portable handheld imaging device connected to the drape of FIG. 12D-F according to the present disclosure. [Figure 12H]12D-12F show an exemplary portable handheld imaging device connected to the drape of FIG. 12D-F according to the present disclosure. [Figure 12I] 1 illustrates another exemplary imaging device that may be used with an imaging drape in accordance with the present disclosure. [Figure 13A] 8 illustrates an exemplary portable handheld imaging device to be used with a drape, such as the drape of FIGS. 2-7, in accordance with the present disclosure. [Figure 13B] 8 illustrates an exemplary portable handheld imaging device to be used with a drape, such as the drape of FIGS. 2-7, in accordance with the present disclosure. [Figure 13C] 8 illustrates an exemplary portable handheld imaging device to be used with a drape, such as the drape of FIGS. 2-7, in accordance with the present disclosure. [Figure 14] 1 illustrates another example of a portable handheld imaging device to be used with a drape in accordance with the present disclosure. [Figure 15A] 15 illustrates a surgical shield or sterile sheath being placed over the portable handheld imaging device of FIG. 14 according to the present disclosure. [Figure 15B] 15 illustrates a surgical shield or sterile sheath being placed over the portable handheld imaging device of FIG. 14 according to the present disclosure. [Figure 15C] 15A-15B coupled to a connecting element of a drape according to the present disclosure. [Figure 16A] 15C shows the ability to couple the sterile shield for a portable handheld imaging device of FIGS. 15A-15B to the drape of FIG. 15C in accordance with the present disclosure. [Figure 16B] 15C shows the ability to couple the sterile shield for a portable handheld imaging device of FIGS. 15A-15B to the drape of FIG. 15C in accordance with the present disclosure. [Figure 16C] 15C shows the ability to couple the sterile shield for a portable handheld imaging device of FIGS. 15A-15B to the drape of FIG. 15C in accordance with the present disclosure. [Figure 16D]15C shows the ability to couple the sterile shield for a portable handheld imaging device of FIGS. 15A-15B to the drape of FIG. 15C in accordance with the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] Description of Various Exemplary Embodiments This description and the accompanying drawings illustrate exemplary embodiments of drapes, imaging devices connectable to various drapes, and structures for connecting the drapes to a surgical sheath, but are by way of example only and should not be construed as limiting. Various mechanical, compositional, structural, electrical, and operational changes may be made without departing from the scope of the claims, including this description and equivalents. In some cases, detailed descriptions of well-known structures and techniques have been omitted so as not to obscure the disclosure. Similar numbers in two or more figures may be omitted. Letters denote the same or similar elements. Furthermore, elements and related features described in detail in connection with one embodiment may, where practical, be included in other embodiments without specific indication or description therewith. For example, if an element is described in detail in connection with one embodiment and not in connection with the second embodiment, the element may still be claimed to be included in the second embodiment.

[0022] When performing fluorescence imaging, it is desirable to have a dark or light-tight environment (i.e., an environment with limited ambient light) to optimize the fluorescence (FL) image obtained. This can be difficult to achieve when the imaging environment has (optical) interference from sunlight, room lighting, or other non-visible electromagnetic radiation. The present disclosure provides an imaging drape that can be positioned over a target to be imaged to reduce or limit ambient light near the target. In some embodiments, the imaging drape can conform around the object to be imaged, including any part of a human or animal body. The drape reduces or limits the amount of ambient light and other electromagnetic radiation present in the imaging environment defined by the interior of the drape. Limiting the amount of electromagnetic radiation, including the amount of ambient light, that enters through the drape into the environment contained within the drape creates a light-tight environment within the drape to perform imaging. While beneficial for fluorescence-based imaging, the light-tight environment created by the drape is also beneficial in white light imaging (to reduce or prevent glare) and in measurements (digital measurements using an image of a target, such as a wound, to obtain measurements). Although drapes according to the present disclosure are generally discussed herein with the purpose of providing a light-shielded imaging environment, it is within the scope of the present disclosure that the drapes are configured to provide a portable imaging environment that reduces or limits glare or provides an anti-reflective effect, rather than providing a light-shielded environment. Such drapes may be beneficial for white light imaging or measurement of imaging targets. Similarly, drapes according to the present disclosure may provide a light-shielded imaging environment and also reduce glare. Drapes according to the present disclosure may provide a light-shielded imaging environment and an anti-reflective effect. It is also within the scope of the present disclosure that the drapes may provide a reduced ambient light environment inside the drape. For example, the drapes may provide a frosted effect such that some, but not all, of the light penetrates through the drape to the interior of the drape. In some examples, the drapes are coated with a fluoropolymer coating to provide an anti-reflective effect. The fluoropolymer coating may be a single-layer interference coating.

[0023] According to one aspect of the present disclosure, a drape configured to reduce or limit ambient light (i.e., a light-blocking drape) is lightweight, compact, and portable. The portable drape is easy for personnel, such as medical personnel, emergency personnel, or other medical personnel, to carry a quantity of the drape for use with a portable handheld imaging device. In this manner, a light-blocking imaging environment can be created in any situation, indoors or outdoors, without concern for ambient light or other electromagnetic radiation interfering with the process of acquiring a target image, such as, for example, a fluorescent image of a wound or injury. The imaging drape can move between a folded / closed / undeployed state and an extended / open / deployed configuration, although it is also contemplated that the drape may be non-foldable and thus packaged in a ready-to-use form.

[0024] The drape may also be used in more controlled environments, such as a clinic or operating room, where light-shielded imaging conditions are desirable but reducing overall ambient light is not. Using the drape creates a portable light-shielded imaging environment that allows fluorescence imaging to be performed in any lighting condition, resulting in high fluorescence image (or video) quality without interference from background light. As previously mentioned, the drape according to the present disclosure allows portable handheld imaging devices to be used at the point of care without the need to turn off the lights. Such portable handheld imaging devices may include one or more of fluorescence-based imaging capabilities, white light imaging capabilities, and target measurement capabilities. An example of such an imaging device is described in US Pat. No. 6,333,353, filed May 20, 2009 and issued May 26, 2015. No. 9,042,967, entitled "Device and Method for Wound Imaging and Monitoring," the entire contents of which are incorporated herein by reference. This device may be used in conjunction with the light-shielding drapes disclosed herein in both clinical and non-clinical applications where it is beneficial to obtain images of the target site using a handheld imaging device. Additional examples of imaging devices that may be used with a light-shielding drape according to the present disclosure are disclosed in U.S. Provisional Patent Application No. 62 / 793,842 (1142.0010-00999), entitled "Modular System for Multi-Modal Imaging and Analysis," filed January 17, 2019, U.S. Provisional Patent Application No. 62 / 793,846 (1142.0011-00999), entitled "Endoscopic System for Visualization of Disease," filed January 17, 2019, and U.S. Provisional Patent Application No. 62 / 793,764 (1142.0012-00999), entitled "Devices, Systems, and Methods for Tumor Visualization and Removal," filed January 17, 2019, the entire contents of each of which are incorporated herein by reference.

[0025] As mentioned above, the drape can be used for fluorescence-based imaging, white light imaging and / or measurements. These processes can be performed sequentially or at separate times. Additionally, a user can use the handheld FL imaging device to perform specific tasks, such as, for example, image-guided sampling and / or wound cleansing and debridement, by lifting a side of the drape for intervention during FL imaging.

[0026] According to the present teachings, the light-blocking drape is a single-use, disposable accessory that can be attached to a portable, handheld imaging device to provide a user with a portable, light-blocking imaging environment to achieve the necessary lighting conditions to perform fluorescent and / or white light imaging. This allows imaging of any target that can be covered, at least partially surrounded, and / or partially enclosed by the interior of the drape. For example, in a clinical application, the drape may be manipulated to surround any imaging site on the human body. The drape may be manipulated to change size or shape to surround, for example, a patient's body limb that includes an imaging target, such as a wound. In another example, the imaging drape and imaging device may be used to image an excised tissue specimen, such as a tumor, cancerous tissue, or other abnormal tissue. This may be done, for example, in a pathology lab immediately after removal of the specimen from the patient. In such a case, the drape may be sized and / or shaped to completely cover or otherwise surround the excised tissue specimen during imaging by the handheld imaging device.

[0027] The drape may be provided and packaged as a sterile unit, so that one exemplary deployment method maintains the inside (patient / patient contact side) of the drape in a sterile condition. In some embodiments, a sterile sheath / surgical drape / sterile shield is placed around some or all of the imaging device to maintain a sterile environment inside the drape and / or prevent contamination of the imaging device. The terms sterile sheath, surgical sheath, surgical drape, and sterile shield are used interchangeably herein to refer to a sheath or drape used for sterilization / contamination reduction purposes by surrounding some or all of the imaging device.

[0028] As used herein, a drape, such as a blackout drape or imaging drape, reduces, limits and / or limits the amount and / or characteristics of ambient light that passes through the drape to the interior of the drape. refers to a drape that is configured to alter the ambient light, and the interior of such a drape may define a portable imaging environment. Thus, a drape that limits or reduces the amount of ambient light passing through the drape body may provide a darkened imaging environment. Alternatively, a drape that alters the characteristics of the ambient light may provide an imaging environment with a quality associated with this alteration, for example, an imaging environment that provides a less glare or anti-reflective imaging environment. The term imaging drape encompasses blackout drapes as well as other types of drapes used to create an altered or tailored imaging environment.

[0029] If a surgical drape is used to cover some or all of the imaging device, the shading drape or imaging drape may be attached to the surgical drape, for example, by connection elements on one or both of the shading drape (or imaging drape) and the surgical drape. Alternatively, or additionally, the inventors contemplate that the surgical drape and the imaging drape may be formed as a single drape, for example, if portions of the drape are appropriately shaped and / or made of appropriate materials for purposes of reducing or limiting ambient light.

[0030] In some embodiments, the drape may include a retaining element that must be broken to remove the drape from the imaging device. When the retaining element is broken, it is no longer configured to attach the drape to the imaging device. Although the drape is intended to be a disposable device and discarded after a single use, it is within the scope of this application that the drape may be used multiple times.

[0031] In such cases, the drape can be made of a material that is easily sterilizable, however, the inventors understand that a user may reuse a non-sterilizable drape or reuse a sterilizable drape for whatever reason regardless of its manufacture from a sterilizable material.

[0032] According to the present teachings, the drape is made of a material that reduces or limits the amount of electromagnetic (EM) radiation that passes from outside the drape through the drape into the interior imaging environment defined by the drape. The amount of EM radiation that is blocked or prevented from passing through the drape is sufficient to prevent interference with imaging modes of the portable handheld device, such as fluorescent imaging mode and white light imaging mode. The drape material substantially reduces the amount of ambient light that is transmitted through the drape into the interior of the drape that defines the imaging environment, such that the imaging device functions optimally. Functioning optimally may include, for example, use of the imaging device in a white light and / or fluorescent imaging mode in which an ambient light sensor of the portable handheld imaging device is not triggered to indicate, for example, the presence of an excessive amount of ambient light. Alternatively, this may include, for example, use of the imaging device in a white light and / or fluorescent imaging mode in which an ambient light sensor is triggered to indicate that there is no interference from ambient light and that the lighting conditions are sufficient to enable imaging. In either case, the imaging device can produce high quality images. The drape may block nearly all visible light (i.e., light with wavelengths between 400 nm and 700 nm) from entering the interior of the drape. The inventors have determined that the amount of ambient (visible) light in the imaging environment must be approximately 402 mW / m2 to provide a fluorescence image of acceptable quality. 2 In some embodiments, the drape has been found to have a power dissipation of approximately 402 mW / m 2 In another embodiment, the drape may be configured to provide an imaging environment having an ambient light of less than about 401.1 mW / m 2 Less than 350mW / m 2 Less than 300mW / m 2 Less than 250mW / m 2 Less than 200mW / m 2 Less than 190mW / m 2 Less than and / or about 185mW / m 2 The device may be configured to provide a portable imaging environment with less than 1000 uW / m2 of ambient light. In one exemplary embodiment, fluorescence imaging was performed in a well-lit hospital room. The amount of ambient light in the room was measured to be 290,200 mW / m2. 2In a portable, light-shielded imaging environment formed by a drape according to the present disclosure, The measured peripheral light level is 184.6mW / m 2 Thus, in this example, the imaging drape prevented approximately 99.94% of the ambient light in the exterior imaging environment from entering the portable imaging environment defined by the interior of the imaging drape.

[0033] As described in more detail below, suitable materials that may be used as drapes include plastics and plastic composites, polymers, rubber materials, paper materials, vinyl materials, and fabric materials. Additionally, the drape material may be coated or impregnated with one or more materials configured to reduce or substantially block the transmission of EM radiation, including ambient light or visible light. In other embodiments, the drape may block substantially all visible light or EM radiation that may interfere with the fluorescent imaging being performed. The drape may be made of a single material or multiple materials. The drape may be formed of multiple pieces or may be a single piece manufactured, for example, by injection molding.

[0034] The imaging device may include an ambient light sensor. The ambient light sensor may detect the level of ambient light in the environment in which the image is taken. If too much or too much ambient light is present in the imaging environment, the sensor may flash a warning, change color to amber or red, or otherwise provide a warning / user feedback that the conditions are not suitable for fluorescent imaging. If the amount of ambient light present in the imaging environment is acceptable for fluorescent imaging, the sensor may flash green for "ready" or "good" or provide another indication or feedback that the conditions are suitable for fluorescent imaging. It is within the scope of this application that the ambient light sensor may provide other warnings or otherwise detect different grades or amounts of ambient light present in the imaging environment. For example, the ambient light sensor may have different ambient light settings / acceptable thresholds for different types of imaging to detect the amount of ambient light that is acceptable to provide a clear image. For example, less ambient light may be desired when taking fluorescent images than when taking white light images. According to one aspect of the present disclosure, for fluorescent imaging, the ambient sensor may detect that the ambient light present is 402 mW / m 2 Alternatively, the ambient sensor may be configured to indicate acceptable imaging conditions if the ambient light present in the imaging environment is less than about 402 mW / m 2 may warn that the conditions for fluorescence imaging are unacceptable.

[0035] According to one aspect of the present disclosure, the drape may be used with a portable handheld imaging device, such as the exemplary device shown in FIG. 1. An example of such an imaging device is described in U.S. Patent No. 9,042,967, entitled "Device and Method for Wound Imaging and Monitoring," filed May 20, 2009, and issued May 26, 2015. The entire contents of U.S. Patent No. 9,042,967 are incorporated herein by reference. This patent describes the characteristics of an imaging device to be used with the drapes disclosed herein, as well as imaging methods, both white light imaging and fluorescence-based imaging, that may benefit from the drapes of the present disclosure. Additional examples of imaging devices that may be used with a light-shielding drape according to the present disclosure are disclosed in U.S. Provisional Patent Application No. 62 / 793,842 (1142.0010-00999), entitled "Modular System for Multi-Modal Imaging and Analysis," filed January 17, 2019, U.S. Provisional Patent Application No. 62 / 793,846 (1142.0011-00999), entitled "Endoscopic System for Visualization of Disease," filed January 17, 2019, and U.S. Provisional Patent Application No. 62 / 793,764 (1142.0012-00999), entitled "Devices, Systems, and Methods for Tumor Visualization and Removal," filed January 17, 2019, the entire contents of each of which are incorporated herein by reference.

[0036] According to one aspect of the disclosure, the drape may have a drape body formed of one or more materials configured to reduce, limit, block or substantially prevent the passage of EM radiation, such as ambient light or visible light. The drape is configured to create an imaging environment for any imaging target that can be partially or completely surrounded by the drape. For example, in various exemplary embodiments, the drape is configured to conform to the shape of any portion of the patient's body, thus allowing imaging of that body part. For example, the drape may be shaped to surround a foot, hand, arm, etc., and create an imaging environment around that body part. Even if the drape does not completely surround the target, it may be attached or adhered to a portion surrounding the target to form an enclosed imaging environment. A portion of the drape body, such as a central portion, may include an attachment device, such as a connection element or connection frame, configured to allow attachment of the drape onto or otherwise connecting to an imaging device. This connection component may be referred to as a connection element, frame portion, or attachment element. For example, the connection element may include a frame portion and a sensor for detecting ambient light conditions, the frame portion configured to receive a portion of a handheld portable imaging device, such as a lens for illuminating a target for fluorescence imaging, a lens portion (also referred to herein as an imaging head or optical head) including one or more excitation light sources (e.g., LEDs) (excitation light sources may include, for example, ultraviolet light, purple / blue light, other wavelengths of visible light, near infrared light, and / or infrared light may also be provided for fluorescence imaging). Depending on the configuration of the imaging device, the portion of the imaging device received in the frame portion of the drape may include other components, such as a white light source for illumination for white light imaging, an image sensor, and / or a spectral filter.

[0037] The connection elements of the drape define an opening in the drape, which thus provides access to the interior of the drape when the drape is in the deployed or extended configuration. The interior of the deployed drape forms a portable imaging environment that is darkened (e.g., has less ambient light) than the surrounding environment outside the drape. A portion of the imaging device (e.g., a lens portion, an imaging head, or an optical head) may be received in a press-fit manner within the connection elements that define the opening, such that ambient light does not enter the portable imaging environment through the opening. This press-fit relationship may be defined as a sealing relationship because it blocks ambient light. Other means may be used to sealingly connect this portion of the imaging device to the connection elements, such as, for example, hook-and-loop fasteners, sealants, adhesives, clips, and other mechanical and / or chemical fastening elements.

[0038] In some exemplary embodiments, the drape may include shaping elements to facilitate conforming the shape of the drape to the target to be imaged such that the site (target) is substantially within the imaging environment (e.g., inside the drape) or is substantially surrounded by the interior of the drape. The shaping elements may be disposed around the periphery of the drape (e.g., bands), extend longitudinally through the drape (e.g., from a top portion of the drape to a bottom or lower portion of the drape), extend diagonally across the drape body, or a combination of such shaping elements. Shaping elements may include, for example, wires, drawstrings, or other elements that are deformable or otherwise capable of facilitating changes in the shape and / or size of the drape.

[0039] In some embodiments, the shaping elements may also serve to maintain the shape of the drape to provide a clear field of view or a clear imaging field of view within the imaging environment (e.g., within the drape body when in the deployed or extended configuration). That is, the shaping elements may act to maintain the shape of the drape to provide a clear field of view or a clear imaging field of view within the imaging environment (e.g., within the drape body when in the deployed or extended configuration). may be sized and positioned to maintain the drape body in a position that does not obstruct or otherwise affect the field of view (FOV) of the lens portion (imaging head or optical head) of the imaging device. In this manner, the shaping element holds the drape body outside the field of view of the lens, such that the drape body does not extend into the field of view between the lens and the target to be imaged.

[0040] In some exemplary embodiments, the bottom portion of the drape may include a mechanism for creating a light-reducing contact with the area surrounding the target. For example, the bottom of the drape may include a weighting element to hold the bottom of the drape in contact with the surface. Alternatively, the bottom of the drape may include one or more fastening elements or mechanisms to provide a connection between the surface around the target and the drape. The surface around the target may be the actual surface that contains the target or a secondary surface such as a support surface or a surface such as a surgical drape that is added for sterilization. Fastening elements or mechanisms may include, for example, magnets, snaps, hook-and-loop closures, adhesives, and other suitable fastening mechanisms. Alternatively, or additionally, the bottom of the drape may include a mechanism for fastening the drape around the imaging target. For example, the drape may include a drawstring, a hook-and-loop closure, a snap, or other mechanism for reducing the diameter / perimeter of the bottom of the drape and pulling it closer around the imaging target.

[0041] Referring now to the drawings, FIG. 1 illustrates an example of a portable handheld imaging device for imaging a wound in tissue without the use of an imaging drape. According to one aspect of the present disclosure, as shown in the exemplary embodiment of FIGS. 2-4, an imaging drape 10 includes a body 20 with an upper portion 30 defined by an upper edge 35, as shown in FIGS. 2 and 3. The upper portion 30 may include an opening 33 within or defined by a connection element 50 that is aligned within the upper portion 30 of the drape 10. As will be described in more detail below, the connection element 50 may receive and secure an imaging device to the drape. In various exemplary embodiments, the connection element is permanently attached to the top of the drape at the time of manufacture such that removal of the drape from the connection element is not intended. Although not shown herein, it is within the scope of the present disclosure that the drape and certain connector elements may be provided separately, such that the connector elements may be reusable with disposable drapes. In such embodiments, it may be necessary to provide a means for attaching the drape to the connector, such as, for example, elastic, adhesive, etc.

[0042] As will be described in more detail below, the drape 10 moves from an undeployed configuration to an open, deployed configuration. In the open, deployed configuration, the body 20 extends radially outward from an upper edge 35 to a lower edge 40, as shown in FIG. 2. In some embodiments, such as those shown in FIGS. 2-4, the diameter of the lower edge 40, as measured in the deployed configuration, is greater than the diameter of the upper edge 35. However, it is contemplated that in some embodiments, the diameter of the lower edge 40 may be approximately the same as the diameter of the upper edge 35, or even be manipulated during deployment to a smaller diameter than the upper edge 35. Additionally, while the measurements described above are presented as radial measurements (e.g., diameters, etc.), it is contemplated that the upper and lower edges of the drape do not necessarily form a circle, but may instead form a triangle, square, rectangle, oval, etc. In such cases, the bottom edge of the drape (after deployment and manipulation) may define an area that is larger than (e.g., enclosed by) the area defined by the top edge of the drape, an area the same size as the area defined by the top edge of the drape, or an area that is smaller in size. Although disclosed herein as being operable from a flat, undeployed state to an extended, deployed state, it is within the scope of this disclosure for the imaging drape to be provided in a ready-to-use form that is not pushable, foldable, or otherwise modifiable for storage.

[0043] The shape and dimensions of the drape are designed so that the sides of the drape body do not enter the field of view of the imaging device. In some embodiments, the diameter of the upper edge is about 60-80%, and in some cases about 70%, of the diameter of the lower edge 40 to help prevent the drape from collapsing inward on the sides in the deployed configuration. In some embodiments, the diameter of the upper edge 35 is about 260 mm or more, the diameter of the lower edge 40 is about 370 mm or more, and the height of the drape in the deployed configuration (from the upper edge 35 to the lower edge 40) is about 260 mm to about 300 mm, and in some cases about 280 mm. As the drape becomes longer, the diameters of the upper and lower edges need to be increased to prevent the drape from collapsing into the field of view of the imaging device. The diameter of the lower edge 40 may range from about 381 mm to about 458 mm. The body 20 may extend radially outward from the upper edge 35 due to one or more shaping elements, as described in more detail below.

[0044] In the deployed configuration, the upper portion 30 extends generally radially outward from the connecting element 50, and the remainder of the body 20 forms a skirt that extends generally vertically from the upper edge 35 to the lower edge 40. The skirt portion of the body 20 that extends between the upper edge 35 and the lower edge 40 may be flexible or rigid.

[0045] In the embodiment of FIG. 2 and FIG. 3, the body 20 has a truncated cone shape in the open, deployed configuration. However, it is contemplated that the body 20 may assume a variety of shapes when in the open, deployed configuration, including, for example, a cylinder, an umbrella, or a rectangle. It is also contemplated that the body 20 may be a truncated pyramid, with a base that is, for example, rectangular, square, pentagonal, or hexagonal. In some embodiments, the body 20 may be a truncated cone, with a base that is either circular or elliptical. The body 20 may be formed of a lightweight and flexible material. In some embodiments, the body 20 is formed of a plastic film, such as, for example, polyethylene or polyolefin. The thickness of the plastic film may range from about 0.05 mm to about 2 mm. The plastic film material of the drape allows the drape to be lightweight, quiet, conform to the patient's body, and easy to package. Alternatively, or additionally, the body 20 may be formed of a paper material, a vinyl material, or a cloth material. However, it is contemplated that the body 20 may be formed of other suitable and / or known materials or combinations of materials.

[0046] The material of the drape body 20 may be a dark color, such as black, to prevent light ingress, thus providing a light-tight imaging environment for FL imaging. The interior of the drape may have a matte and / or non-reflective finish to reduce glare or reflections from the excitation light illuminating the target during imaging. Additionally, the interior and / or exterior of the drape may include a coating configured to limit the passage of electromagnetic radiation, such as infrared or ultraviolet light. Alternatively, the interior and / or exterior of the drape may include a coating configured to limit the passage of some, but not all, visible light. For example, the coating may provide a frosted effect on the drape. The interior of the drape may also be sterilized during manufacture or prior to use.

[0047] 2 and 3, the upper edge 35 is a weld between the top 30 and the skirt portion forming the body 20, forming a raised edge or weld on the body 20. One or more shaping elements 60, e.g., wires, may be used to form the edge of the upper edge 35. However, it is contemplated that the body 20 may not include such a discrete edge. Instead, for example, the body 20 may extend continuously radially outward and downward from the connecting element 50 toward the lower edge 40 (e.g., a type of umbrella shape in which the connecting element is aligned with the apex of the umbrella shape).

[0048] The top portion 30 of the drape 10 may have a generally flat shape and may extend generally horizontally away from the connecting elements 50 when the drape 10 is unfolded. In this manner, an imaging device connected to the frame and "seeing" the interior of the drape (i.e., the imaging environment) may be provided. The field of view of the lens portion of the drape (imaging head or optical head) remains clear, i.e., unobstructed by the body 20 of the drape 10. Such a generally flat top portion of the drape is shown in the embodiment of the drape shown in Figures 2 and 3. Top portion 30 may be rigid or flexible.

[0049] As discussed above, the drape 10 may include one or more shaping elements 60 that hold or support the drape material away from a central portion of the imaging environment created by the drape body. This allows the field of view of an imaging device connected to the drape to remain unobstructed by the drape body during imaging. These shaping elements may include, for example, wires, stiffeners, and other materials. In some embodiments, the shaping elements 60 may be formed of, for example, steel, aluminum, titanium, or plastic. In one example, the shaping elements 60 are formed of 18 gauge mild steel wire hoops. It is also contemplated that the shaping elements 60 may be formed by a seam in the material of the drape body 20. In some embodiments, the material of the drape body 20 is welded together to form the seam. In one exemplary embodiment, a weld between the top portion 30 and the skirt forming the body 20 may be sufficient to hold the body 20 out of the field of view of the imaging device. To accomplish this, the diameter of the bottom portion of the drape must be sized larger than the top portion of the drape to prevent the sides of the drape from collapsing in. For example, the top diameter of the drape may be about 70% of the bottom diameter of the drape.

[0050] The shaping elements are also flexible and can change the shape of the drape body and retain the changed shape to hold the drape body in a shape that conforms to a portion of the patient's body to be imaged, such as a body limb containing a wound or other imaging target. In an exemplary embodiment, the shaping elements 60 may be positioned at the top of the drape and about 2.5 inches from the bottom of the drape. For example, as shown in Figures 3 and 4, a first shaping element 63 is positioned at the top edge 35 and a second shaping element 65 is positioned adjacent the bottom edge 40. As shown, these shaping elements 63, 65 extend along the perimeter of the drape at each location. It is also contemplated that the second shaping element 65 may be positioned along the bottom edge perimeter of the drape 10, such as at the bottom edge 40. The first and second shaping elements 63, 65 are spaced apart a sufficient distance to allow the drape 10 to assume its desired shape in the open, deployed configuration.

[0051] The shaping elements 63, 65 are configured to allow the drape body 20 to bend and manipulated to conform to the contours of an imaging target, such as a patient body part, while maintaining the deployed shape of the drape body 20 to create ideal lighting conditions for FL imaging within the portable imaging environment. For example, the shaping elements 63, 65 may be wires that an operator can easily bend into various shapes, allowing the drape to bend to better conform to the body shape of the patient to be imaged. Alternatively, or additionally, the shaping element 60 may help maintain a clear field of view for the imaging device by keeping the drape body away from the center of the portable imaging environment created within the drape body.

[0052] FIG. 3 shows one embodiment of forming elements 63, 65 having a circular shape. However, the forming elements may include a variety of shapes depending on the desired shape of the drape body 20. The forming elements 63, 65 may be located on the inside or outside of the drape body 20. In some embodiments, the forming elements 63, 65 may be embedded into the material of the drape body 20. Although two forming elements are shown in the embodiment of FIGS. 2-4, it is contemplated that only one forming element may be used or that more than two forming elements may be used, for example, three, four, five, six or more forming elements may be used.

[0053] The skirt or body portion 20 of the drape 10 may be smooth and taut, as shown in the exemplary embodiment of Figures 2-4, or may be loosely suspended and hang downward from the top portion (i.e., draped), as shown in Figures 5A-5C.

[0054] According to another aspect of the disclosure and as shown in Figures 5A-5C, the drape 10 can be moved from a non-deployed configuration to an open, deployed configuration. In the non-deployed configuration (Figures 5A and 5B), the body 20 is generally flat such that the lower edge 40 and the upper edge 35 are in the same plane. Thus, in some embodiments using shaping elements, in the non-deployed configuration, the first shaping element 63 is also generally in the same plane as the second shaping element 65. However, in the open, deployed configuration (Figure 5C), the lower edge 40 is disposed below the upper edge 35 in the longitudinal direction of the drape 10. The imaging device can be secured to the connecting element 50 either before or after the drape is moved from the non-deployed configuration to the open, deployed configuration. It is contemplated that the imaging drape can have a variety of shapes when in the non-deployed configuration. For example, the drape may be folded with the bottom edge of the drape below the top portion 30, so that the user must open or unfold the drape by pulling it up onto the connection elements 50. In some instances, it may be desirable to connect an imaging device to the connection elements 50 of an undeployed drape and then unfold the drape 10 by pulling the imaging device up as the drape 10 is moved away from the support surface on which it was placed.

[0055] 6A-6C show another exemplary embodiment of an imaging drape, drape 100. Drape 100 includes a body 120 with a first drape portion 170 and a second drape portion 180. As with other embodiments discussed herein, drape 100 includes an upper portion 130 that includes a connecting element (not shown) that defines an opening 133. The body 120 may extend from an outer edge or periphery 137 of the connecting element to a lower edge 140 of the drape 100. In the exemplary embodiment of FIGS. 6A and 6B, the upper portion 130 of the drape is not defined by an upper edge. Instead, the upper portion 130 slopes radially downward into the second drape portion 180 to provide a smooth, continuous transition with the remainder of the body 120 at the second drape portion 180.

[0056] The first drape portion 170 of the drape 100 may be disposed above the second drape portion 180 in the longitudinal direction of the drape 100. In some embodiments, the first drape portion 170 is a skirt or umbrella portion comprising a plurality of ribs 175 extending vertically of the drape 100. The ribs 175 may be spaced apart from one another laterally of the drape 100. The spacing may be consistent between each rib, or the spacing may vary between different ribs. Each rib 175 may be formed of a rigid material. The material of the body 120 in the first drape portion 170 may be disposed over or underneath the ribs 175. Thus, in some embodiments, the ribs 175 may be disposed on an exterior surface of the body 120. It is also contemplated that the ribs 175 may be embedded within the material of the drape body 120.

[0057] The second drape portion 180 may be directly connected to a lower edge portion of the first drape portion 170. The second drape portion 180 may depend radially outward from the first drape portion 170 such that the lower edge of the second portion 180 has a larger outer diameter than the lower edge of the first drape portion 170. The length of the second drape portion 180 in the longitudinal direction of the drape 100 may be longer than the length of the first drape portion 170. Also, the length of the second drape portion 180 may be the same length as the first drape portion 170 or shorter.

[0058] In some embodiments, the body 120 of the first drape portion 170 is formed of a different material than the body 120 of the second drape portion 180. The first drape portion 170 may be formed of a stiffer, harder, or more rigid material than the second drape portion 180. Alternatively, ribs may pull the material taut in the first drape portion 170, giving the first drape portion 170 a smoother appearance than the second drape portion 180. In some embodiments, the second drape portion 180 is formed of a soft cloth-like material that is flexible and lightweight and easily draped onto an object, as shown in FIG. 6A. It is also contemplated that the body of the first drape portion 170 may be formed of either a flexible or rigid material. Thus, the skirt of the first drape portion 170, including the ribs 175, may be flexible or rigid in the unfolded state.

[0059] The lower portion of the second drape portion 180 may include one or more fastening elements 190 to aid in closely adhering to the contours of the imaging target at the lower portion of the drape body, e.g., the patient's body having the imaging target, such as a wound. Fastening elements 190 include weighted elements, magnets, drawstrings, tapes, wires, hook or loop closures. In the embodiment of FIGS. 6A-6C, the fastening elements 190 are weights spaced around the lower edge of the second drape portion 180. The fastening elements 190 may help secure the drape 100 to the patient to reduce / prevent inadvertent movement of the drape 100 relative to the patient. This may help reduce the amount of ambient light entering the interior of the drape during wound imaging. In some embodiments, the fastening elements 190 are magnets that are magnetically coupled to a magnet (e.g., a magnetic sticker) located on the patient.

[0060] It is also contemplated that any of the embodiments discussed herein may include a fastening element 190 on the drape body. Although referenced in connection with Figures 6A-6C, the fastening element 190 is not limited to this embodiment.

[0061] As discussed above, in the embodiment of Figures 6A-6C, the drape 100 may include one or more shaping elements, which may be located in the upper and lower regions of the drape.

[0062] The ribs 175 may extend generally vertically from the first shaping element to the top of the second drape portion 180. In other embodiments, the ribs 175 may extend from the opening 133 to the top of the second drape portion 180. The skirt of the first drape portion 170 is kept out of the field of view of the imaging device. This may be accomplished in a variety of ways, for example, by using a second shaping element (as discussed above) at the bottom or hem of the skirt portion that extends around the periphery of the skirt portion, by using vertical ribs 175, or by other means that tension the skirt portion to keep it extended away from the central portion of the light-shielded imaging environment.

[0063] In the undeployed configuration, the ribs 175 may be compressed in an accordion style, such that the first portion 170 of the drape 100 may be closed into a relatively flat shape, as shown in Figure 6C.

[0064] 7 illustrates yet another exemplary embodiment of an imaging drape, drape 200. Drape 200 includes a body 220 that includes a first drape portion 270 and a second drape portion 280. As with the other embodiments discussed herein, drape 200 includes an upper portion 230 that includes a connecting element (not shown) that defines an opening 233 (not shown) within which an imaging portion of an imaging device may be aligned to view an imaging target. Body 220 extends from a perimeter 237 of the connecting element to a lower edge 240 of drape 200. In the embodiment of FIG. 7, upper portion 230 is not defined by an upper edge. Instead, Instead, the top portion 230 slopes radially downward into the second drape portion 280 to provide a generally smooth, continuous transition with the remainder of the body 220 in the first drape portion 270 when the drape is in an expanded, deployed configuration. In some embodiments, the pleating in the first portion 270 may give the first portion 270 a wavy rather than a smooth appearance.

[0065] The first drape portion 270 of the drape 200 may be disposed above the second drape portion 280 in the longitudinal direction of the drape 200. In some embodiments, the first drape portion 270 has a bellows or accordion structure with a plurality of pleats 275 that fold over one another in a closed configuration. The pleats 275 may be formed within the material of the first drape portion 270. The second drape portion 280 may extend longitudinally from the first drape portion 270 to the bottom edge 240. The second drape portion 80 may be formed of a soft cloth-like material that conforms to the surface of the patient to be imaged. Thus, the second drape portion 280 may not include pleats. In some embodiments, the first drape portion 270 is formed of a resilient plastic material and the second drape portion 280 is formed of a soft plastic material.

[0066] In another exemplary embodiment, instead of pleats, the first drape portion 270 may be provided with a plurality of first ribs 275 extending horizontally of the drape 200. The first ribs 275 may be spaced apart from one another along the length of the drape 200. The spacing may be consistent between each rib, or the spacing may vary between different ribs. Each rib 275 may be formed of a rigid material. The material of the body 220 of the first drape portion 270 may be disposed over or underneath the ribs 275. Thus, in some embodiments, the ribs 275 may be disposed on an outer surface of the body 220. It is also contemplated that the ribs 275 may be embedded within the material of the drape body 220. In such an embodiment, when the drape is in a collapsed or undeployed configuration, the ribs may be flat, similar to that shown in FIG. 5A, but the shape of the undeployed drape will be rectangular rather than circular.

[0067] The first drape portion 270 may also include one or more second ribs 279 that extend vertically across the drape 200. The second ribs 279 may provide stability to the ribs 275 to prevent the body of the drape from inadvertently collapsing.

[0068] In any of the exemplary embodiments of the first drape portion 270 comprising pleats or ribs, the second drape portion 280 may include a fabric-type panel 277 configured to receive a fastening element 290, as discussed above. In one example, the panel 277 may be folded over the fastening element 290 to secure the fastening element 290 onto the drape.

[0069] The second drape portion 280 may be directly connected to a lower edge portion of the first drape portion 270. The second drape portion 180 may depend radially inward from the first drape portion 270 such that the lower edge of the second drape portion 280 has a smaller outer diameter than the lower edge of the first drape portion 270. The length of the second drape portion 280 in the longitudinal direction of the drape 200 may be shorter than the length of the first drape portion 270.

[0070] When moving from the open, deployed configuration to the undeployed configuration, the pleats / ribs 275 fold over one another such that the drape 200 assumes a generally flat profile in the undeployed configuration, and thus the drape 200 is easily collapsible.

[0071] As discussed above, the lower portion of the second drape portion 280 is attached to the lower portion of the drape body. The drape 200 may include one or more fastening elements 290 to aid in closely adhering to the contours of the patient's body when in contact with the patient's skin. Fastening elements 290 include weighted elements, magnets, drawstrings, tapes, wires, hook or loop closures. In the embodiment of FIG. 7, the fastening elements 290 are weights spaced around the lower edge of the second drape portion 280. The fastening elements 290 may help secure the drape 200 to the patient to reduce / prevent inadvertent movement of the drape 200 relative to the patient. This may help reduce the amount of ambient light entering the drape when imaging the wound. In some embodiments, the fastening elements 290 are magnets that are magnetically coupled to a magnet (e.g., a magnetic sticker) located on the patient.

[0072] It is also contemplated that any of the embodiments discussed herein may include a fastening element 290 on the drape body. Although referenced in connection with FIG. 7, the fastening element 290 is not limited to this embodiment.

[0073] As discussed above, in the embodiment of FIG. 7, the drape 200 may also include one or more shaping elements, which may be located in the upper and lower regions of the drape.

[0074] According to another aspect of the present disclosure, an imaging device (such as the imaging device of FIG. 1 or FIGS. 12G-16D) may be positioned over or partially within the opening 33 of the connecting element such that the lens portion / imaging head / optical head is aligned to view an imaging target inside the drape (portable imaging environment).

[0075] With the imaging device connected to the drape, the drape is positioned such that the interior of the drape at least partially surrounds or encircles the surface against which the imaging target is aligned. For example, if the imaging target is a wound on the bottom of the foot, the drape may be aligned to encircle the foot. Alternatively, for example, if the target is a wound on the leg as shown in FIG. 7, the drape is aligned to encircle the surface against which the target is aligned. The drape may be secured to the surface to minimize ambient light created by the drape and entering the portable imaging environment within which the target is aligned.

[0076] After aligning the drape, an imaging device, comprising at least a lens and an excitation light source aligned to have a target in the portable imaging environment within its field of view (FOV), is activated to emit excitation light to illuminate the target, such as a wound. If fluorescence imaging is being performed, the drape used is a light-blocking drape configured to provide a light-blocking imaging environment with reduced or limited ambient light. Thus, the drape may reduce / prevent ambient light from entering the interior environment of the drape. The inventors have determined that to provide an acceptable quality fluorescence image, the amount of ambient (visible) light in the imaging environment should be approximately 402 mW / m 2 In some embodiments, the drape has been found to have a power dissipation of approximately 402 mW / m 2 The imaging environment may be configured to provide an imaging environment having less than 402 mW / m2 of ambient light. Thus, the inventors set the ambient light threshold / tolerance level for fluorescence imaging at approximately 402 mW / m2. 2 In another embodiment, the drape has an ambient light of about 401.1 mW / m 2 Less than 350mW / m 2 Less than 300mW / m 2 Less than 250mW / m 2 Less than 200mW / m 2 Less than 190mW / m 2 Less than and / or about 185mW / m 2The device may be configured to provide a portable imaging environment with less than 1000 uW / m2 of ambient light. In one exemplary embodiment, fluorescence imaging was performed in a well-lit hospital room. The amount of ambient light in the room was measured to be 290,200 mW / m2. 2 The ambient light measurement in the portable, light-shielded imaging environment created by the drape according to the present disclosure was 184.6 mW / m 2 Thus, in this example, the imaging drape prevented approximately 99.94% of the ambient light in the exterior imaging environment from entering the portable imaging environment defined by the interior of the imaging drape.

[0077] As discussed above, the connection element 50 is configured to secure the imaging device to the drape during the imaging procedure. The connection element 50 may be attached to the drape via welding, adhesive, or any other known attachment means. It is also contemplated that the connection element 50 and drape 10 may be formed as a single piece. The connection element 50 may be removably attached or permanently attached to the drape. In some embodiments, the connection element 50 is formed of an injection molded plastic material, such as, for example, high density polyethylene.

[0078] As shown in the exemplary embodiment of FIG. 8A, the connection elements 50 form a frame around the opening 133, which is an opening into the drape body and through which the imaging device "sees" the imaging target to image the target. The frame may be generally rectangular in shape and includes an upper planar surface 103 and one or more gripping elements configured to "hold" the imaging device. The gripping elements may be referred to herein as clasps, clamps, or clips. The gripping elements 105 (e.g., connectors) protrude outwardly from the surface 103 when the gripping elements 105 are in an open configuration. The gripping elements are configured to rotate within a range of motion of about 90 degrees from the open configuration (FIG. 8A) to the closed configuration (FIG. 8B). When in the open configuration, the gripping elements 105 may have a slight bias inward toward the center of the connection elements 50, such that the imaging device may be secured to the upper planar surface 103 of the connection elements 50 between the gripping elements 105. The gripping elements 105 thus secure the imaging device with a snap-fit ​​arrangement. However, it is contemplated that the imaging device may be secured to the connecting element 50 using, for example, clips, straps, tape, Velcro, adhesive, buttons, or other known attachment means. FIG. 8C illustrates an imaging device secured within the gripping element 105.

[0079] 8B, gripping elements 105 fold down to be flush with surface 103. For example, in the closed configuration, gripping elements 105 may fit into recesses 107 when folded down, minimizing their vertical extension from surface 103. This may help minimize height and space requirements during packaging.

[0080] 8A and 8B, the plane 103 forms an aperture 133, which may be generally kidney-shaped. When the imaging device is placed within the connecting element 50, the lens and excitation light source of the imaging device are aligned with the aperture 133 such that FL light from the imaging device is emitted through the aperture 133. Furthermore, the aperture 133 is made large enough such that the body of the imaging device blocks the top of the aperture, thereby preventing ambient light from entering the interior of the drape environment through the aperture. Thus, the aperture 133 of the connecting element 50 is configured to sealingly engage the imaging device to prevent electromagnetic radiation from passing through the aperture into the interior of the drape.

[0081] 8A-8D show plan views of the connection element 50. FIG. 8E shows the bottom side of the connection element 50, which is disposed on the inside portion of the bottom of the drape when the connection element 50 is attached to the drape. The bottom side of the connection element 50 includes a bottom planar surface 104 and one or more protrusions 54 extending from the surface 104. The protrusions 54 may be spaced apart to give the drape structure to prevent the material of the drape from collapsing into the field of view. The protrusions 54 are also flexible and thus can flex to allow for imaging near a surface such as a wall or bed. The planar surface 104 and protrusions 54 may also prevent / reduce light from entering the interior of the drape through the connection between the drape and the imaging device.

[0082] The underside of each of the planes 103, 104 includes an adhesive for attachment to a drape. As such, the underside of these surfaces may include an adhesive backing. However, it is contemplated that the planes 103, 104 may each be attached to the drape via any known attachment means, such as welding, Velcro, staples and / or tape. Additionally, valves 55 may be located through the planes 103, 104 to aid in the deployment of the drape, as will be described in more detail below.

[0083] 8F and 8G show the bottom of the connection element 50 and the drape with an imaging device disposed within the opening 133. As will be described in more detail below, a lens of the imaging device and an excitation light source are disposed within the opening 133 to perform FL imaging within the portable imaging environment of the drape. A white light source, such as a flash, may also be disposed in the portion of the imaging device disposed within the opening 133.

[0084] It is also contemplated that other connection elements may be used to attach the imaging device to the drape, including, for example, clips, hook and loop fasteners. These other connection elements may be used separately from the connection element 50 or may be incorporated into the connection element 50. FIG. 8H illustrates another exemplary embodiment of the connection element 50 in which the gripping elements 105 are offset from one another. Such an embodiment may be used to reduce inadvertent movement of the imaging device when secured to the connection element 50.

[0085] 8I illustrates an embodiment in which the connection element 50 is attached to a mask 700, which may be formed, for example, from a polyethylene film. The mask 700 may include an adhesive backing that adheres to the surface 104 of the connection element 50. The mask 700 may prevent / reduce the ingress of light leakage through the connection point between the imaging device and the drape. The mask 700 may include one or more through holes 720 configured to align with the flap valves 55, as described below.

[0086] As discussed above, the imaging device may be secured to the drape either before or after the drape is deployed. FIG. 9A shows an imaging device secured to the drape in a non-deployed configuration. FIGS. 9B and 9C show an imaging device secured to the drape in an open, deployed configuration. In the non-deployed configuration, the drape may be generally flat. In either configuration, the drape is generally flexible. For example, as shown in FIG. 9A, when non-deployed, the drape may have a circular shape. However, it is also contemplated that the drape may take on various shapes in the non-deployed and deployed configurations. According to one aspect of the present disclosure, the drape may be stored in a sterile state prior to use. The drape may be stored, for example, on a dispenser device 320, such as the device shown in FIGS. 10A-10C. FIG. 10D shows an image of an exemplary drape in a non-deployed state on a dispenser device 320. As shown in Figures 10A-10C, the dispenser device 320 includes first and second cavities 323, 325 on a plane 324 separated by a first wall 327. A second wall 329 forms a boundary along the periphery of the second cavity 325. The first and second walls 327, 329 may form constraining elements and each may have a height that extends upward from the plane 324 of the dispenser device 320. Figures 10A-10C show the walls 327, 329 as being concentrically aligned and having a circular shape. However, it is contemplated that the walls may include any shape as is known in the art. In some embodiments, the walls have the same shape as the shaping element 60.

[0087] 10D, the cavities 323, 325 are configured to receive the drape body without entanglement of the drape material, thereby promoting uniform deployment of the drape. Additionally, the first and second walls 327, 329 may form a barrier configured to engage with the shaping element 60 of the drape. For example, shaping element 60 may be disposed between walls 327 and 329 and within cavities 323, 325 of dispenser device 320 when the drape is in a closed, undeployed configuration.

[0088] The walls 327, 329 and shaping element 60 are configured to cooperate with one another to facilitate deployment of the drape. FIG.

[0089] The dispenser device 320 may be made of, for example, cardboard, plastic, or rubber. The interior of the drape may be kept sterile relative to the dispenser device 320 when the drape is in the closed, undeployed configuration.

[0090] In an exemplary embodiment, one or more one-way valves, such as flap valves 55 on the connection element 50, may aid in the deployment of the drape from the dispenser device 320. As the drape moves from a closed or undeployed configuration to an open, deployed configuration, for example, as the drape is pulled away from the dispenser device 320, air may move from the outside of the drape to the inside of the drape through the flap valves 55. This movement of air into the interior of the drape creates a higher air pressure inside the drape than outside the drape, thus helping to maintain and hold the drape in the open, deployed configuration. During imaging, the flap valves 55 remain closed. The flap valves 55 may be formed of the same material as the material of the drape body 20. Each flap valve 55 may be a piece of material secured to the connection element 50 over a hole in the connection element 50. Although described in connection with the dispenser device 320, the flap valve 55 can also assist in deploying the drape when the dispenser device 320 is not in use, for example, when the drape is opened from a closed configuration on a user's work desk.

[0091] 11A-11C, when stored in a sterile condition, the drape may include a sterile cover 330. The cover 330 is, for example, aligned between the planar surface 103 of the connecting element 50 and the gripping element 105, and aligned over the opening 133. Removal of the sterile cover 330 opens the gripping element 105 from a closed, stored position to an open position for receiving the handheld imaging device, exposing the opening 133 for receiving the lens portion of the imaging device. The sterile cover 330 may have approximately the same shape as the opening 133 in the connecting element 50.

[0092] FIG. 11C shows the sterile cover 330 aligned over the drape, FIG. 11B shows the sterile cover 330 as it is being pulled up and removed from the drape, and FIG. 11A shows the drape with the sterile cover 330 removed.

[0093] 12A-12C show another exemplary embodiment of an imaging drape 500. In FIGS. 12D-12F, the imaging drape 500 is shown connected to an imaging device. The drape 500 includes a connection element 501. In this exemplary embodiment, the connection element 501 does not include a gripping element as previously described to assist in securing the imaging device to the drape. Instead, the connection element 501 includes ridges 510 that are used to form a press-fit or snap-fit ​​connection with the imaging device. A protrusion on the imaging device (described below) may engage with the ridges 510 to provide a press-fit or snap-fit ​​connection. Additionally, one or more protrusions 520 may be configured to engage with protrusions on the imaging device to grip and better secure the imaging device to the drape. In some embodiments, the protrusions 520 are teeth-like members that engage with protrusions on the imaging device. When the imaging device is properly aligned and pressed down into the connecting element, the protrusions 520 clip onto the projections on the imaging device, creating a snap fit. Provides connectivity.

[0094] The connecting element 501 may also include end cup members 550 to help facilitate a snap-fit ​​connection between the connecting element 501 and the imaging device. As shown in FIG. 12A, the end cup members 550 may be smooth members disposed on either end of an opening 533 formed in the connecting element 501. The end cup members 550 may provide guidance for centering / aligning the imaging / optical head of an imaging device that is snap-fitted onto the connecting element 501.

[0095] FIG. 12A illustrates the shape of the opening 533 as a rectangle with the protrusion 520 disposed on the long side of the rectangular shape and the end cup member 550 disposed on the short side of the rectangular shape. However, it is contemplated that the protrusion 520 may be disposed on the short side of the rectangular shape and the end cup member 550 may be disposed on the long side of the rectangular shape. Although FIG. 12A illustrates two end cup members 550, only one end cup member 550 may be used on one side of the opening 533. Additionally, in some embodiments, the connecting element 501 may not include an end cup member 550. In such embodiments, the protrusion 520 may be disposed around most or the entire circumference of the opening 533 on the connecting element 501. The connecting element 501 may be formed of injection molded plastic as discussed above.

[0096] Figure 12A is a top perspective view showing connection element 501 secured to a drape, Figure 12B shows a top view of connection element 501 and the exterior of the drape, and Figure 12C shows a bottom view of connection element 501 and a view of the portable imaging environment formed by the interior of the drape.

[0097] Similar to the previously discussed embodiments, the connection element 501 may also include a top planar surface 503, a one-way valve, such as a flap valve 555, and a protrusion 554. However, in the embodiment of Figures 12A-12F, the protrusion 554 is located on the top surface of the connection element 501. Thus, the protrusion 554 is visible in the top view of Figure 12B, but not from within the drape in the view of Figure 12C. The protrusion 554 helps to keep the drape material out of the imaging field, as previously discussed.

[0098] In the embodiment of FIGS. 12A-12F, the connection element 501 may be formed of an injection molded plastic, such as polyethylene. Thus, the connection element 501 may be a relatively stiff member. In some embodiments, the connection element 501 has a thickness of about 1.8 mm. The protrusions 554 may be formed of the same material as the remainder of the connection element 501, but may not be as stiff as the remainder of the connection element 501. Thus, the protrusions 554 may be thinner than the remainder of the connection element 501. The material of the drape body may be formed of the same material as the connection element 501, but may not be injection molded such that the material of the drape body is not as stiff as the connection element 501 (including the protrusions 554). In some embodiments, the material of the drape body is also thinner than the connection element 501 (including the protrusions 554). The drape body may be formed of a flexible material that is welded to the relatively stiff material of the connection element 501. This may reduce manufacturing costs since the flap valve 555 may be formed from the material of the drape body, thereby allowing the flap valve 555 to be integrated into the drape.

[0099] Similar to the embodiment discussed above, the connecting element 501 also includes an aperture 533 to provide FL and / or white light imaging from the imaging device into the interior environment of the drape. In the embodiment of Figures 12A-12C, the shape of the aperture 133 is generally rectangular, as discussed above. However, it is further contemplated that other shapes may be used.

[0100] Figures 12D-12F show an example of an imaging device 600 secured to the connection element 501 of the drape shown in Figures 12A-12C. As discussed above, the imaging device 600 is fixedly fastened to the connection element 501 via a snap-fit ​​connection that prevents / reduces ambient light from entering the drape interior through the top of the drape. A protrusion 670 on the imaging device 600 can engage with a projection 520 and a ridge 510 on the connection element 501 to provide the snap-fit ​​connection, as discussed above.

[0101] An exemplary embodiment of a modular handheld imaging device 600 is shown in Figures 12G and 12H. The imaging device 600 includes a base body portion 610 having a generally square or rectangular shape. The front or user-facing side of the base body portion 610 includes a display screen 620 for displaying images and videos captured by the device. A protrusion 670 projects outwardly from the optical head / optical housing 640, but may alternatively be positioned on the base body portion 610. Although Figure 12G illustrates the protrusion 670 as being located on a top portion of the base body portion 610, it is also contemplated that the protrusion 670 may be located on the other side of the base body portion 610 depending on the location of the protrusion 520 on the connecting element 501.

[0102] Although imaging device 600 is depicted as a square or rectangle, it may take any shape that reasonably supports a display screen, such as a touch screen, which, in addition to disclosing images captured by imaging device 600, also acts as a user interface, allowing a user to control the functions of the device via touch screen input.

[0103] The opposite side of the device, i.e., the patient-facing side of the device, may be aligned with a hand-holding portion 630 configured to facilitate a user holding the device during imaging. The patient-facing side of the device may also incorporate contacts 635 for wirelessly charging the device.

[0104] According to one aspect of the present disclosure, the patient-facing side of device 600 also includes an optical housing 640. Optical housing 640 may be detachable from base body portion 610. Optical housing portion 640 is shown as a rectangular housing configured to be received in an opening in a connection element on a drape.

[0105] The optical housing 640 may take different shapes. For example, as shown in FIG. 12H, the optical housing portion 640 has a generally flat oval shape. The optical components for FL and / or white light imaging are arranged in a generally linear manner across the width of the optical housing. The optical components are described in more detail below.

[0106] In some embodiments, the optical components may be disposed at the distal tip 660 of the endoscope 650, as shown in FIG. 12I. The endoscope 650 may then be disposed within the opening of the connection element to direct the FL and / or white light image onto the area of ​​the patient to be imaged. Upon connection with the optical portion of the endoscope 650, the connector 501 of the drape may have a circular shape. Alternatively, or additionally, the endoscope 650 may include a shield similar to that described below in connection with FIGS. 15A-15C, which may then be connected to a portable imaging environment according to the present disclosure.

[0107] It is within the scope of this disclosure that various aspects of the previously described embodiments of the drape may be combined. Thus, features of each of these embodiments may be combined with features of other embodiments. Various features of different embodiments are not mutually exclusive and may instead be combined as would be understood by one of ordinary skill in the art. An example of deployment and use of a drape with a ht i:X imaging device is described. This method may include acquiring a fluorescent-based image or video of a target area of ​​a patient without altering ambient light conditions. First, the drape is removed from its sterile packaging. The operator may then remove the sterile cover 330 on the connection element 50. Removing the sterile cover 330 causes the gripping element 105 to open and protrude upward. The imaging device is then clipped onto the gripping element 105 of the connection element 50 and attached to the drape. The lens of the imaging device fits into the opening 133 on the connection element 50. The operator may then lift the imaging device away from the dispenser device 320, so that the drape is deployed in one simple motion with air moving through the valve 55.

[0108] Once the drape is deployed, the operator may align the drape over the area of ​​the patient to be imaged. The body of the drape may nest within various contours of the patient's body. In some embodiments, the fastening elements 190 may be coupled to magnetic stickers on the patient's body to provide proper alignment of the drape with the contours of the patient's body. It is also contemplated that the operator may bend or otherwise manipulate the shaping elements 60 to better nest the drape within the contours of the patient's body.

[0109] The operator may then verify that proper imaging conditions are met, e.g., that the drape's internal environment is dark enough. If the drape body is not properly nested against the patient's body contours, the drape's internal environment may not be dark enough. The operator may verify that the imaging device's ambient light sensor indicates that proper imaging conditions are met. In some embodiments, the ambient light sensor may display green if proper imaging conditions are met.

[0110] The operator may turn on the purple LED and capture an FL image or video with the drape. Alternatively, or additionally, the operator may capture an image or video with the drape with white light imaging. Once imaging is complete, the drape is removed from the patient and imaging device. The drape may then be discarded or sterilized for reuse.

[0111] The drape may be manufactured according to the exemplary methods discussed below. The material forming the body 20 of the drape may be cut into an arc shape and then formed, for example, into a frusto-conical shape (the outer arc length of the arc forms the lower circumference of the cone and the inner arc length of the arc forms the upper circumference of the cone). Additionally, the material forming the body 20 of the drape may be cut into a circular shape with openings for attachment to the connection elements 50 / 501. The circular shape may then be welded into the frusto-conical shape to form the drape.

[0112] The connection element 50 / 501 may be formed by injection molding. The connection element 50 / 501 may be welded to the material of the drape body, for example by plastic welding. However, it is contemplated that other attachment methods may be used. In some embodiments, for example in embodiments where the body of the drape and the connection element 50 / 501 are formed of molded rubber, these components may be integrally formed. The metal wires forming the molded elements may be embedded in the drape by tapping or welding.

[0113] Drapes are manufactured and packaged such that the end user receives a sterile product, and the drape may be unfolded from its packaging by an operator without compromising the sterility of the drape's inner wall (the portion of the drape that contacts the patient).

[0114] An exemplary method for obtaining measurements of a target without altering the ambient light includes removing the cover 330 from the opening of the drape. The operator may then attach an imaging device to the drape while the drape is connected to a packaging element, such as the dispenser device 320. The operator may then move the imaging device and attached drape away from the packing element and unfold the drape. The operator may align the open bottom edge of the drape over the body part that includes the target to be measured. A portion of the drape surrounding the body part that includes the target to be imaged may be contoured to create a light-tight environment around the body part that includes the target to be measured, such that the drape is configured to limit the passage of electromagnetic radiation through the drape into the light-tight environment. The operator may also measure a target on the body part with an imaging device attached to the drape. As detailed above, the target part may be a wound, a lesion, a cut, an incision, or a tumor. When imaging a wound with FL, the clinician's intent may be to visualize bacteria within the wound. During FL imaging of bacteria, when illuminated with blue / violet excitation light, e.g., excitation light having a wavelength of 405 nm±10 nm, the bacteria emit a fluorescent signal in response to the illumination. The signal may have a wavelength between about 500 nm and about 550 nm and greater than about 600 nm, optionally between about 600 nm and about 660 nm. A filter in the imaging device is configured to allow a signal corresponding to this autofluorescence of the bacteria to pass through the filter and reach the image sensor of the imaging device.

[0115] An operator may measure a target on a body part by capturing and viewing a white light image of the target on a screen of an imaging device. The white light image may be captured in a light-blocking environment with a drape. Alternatively, or additionally, an operator may measure a target on a body part by capturing and viewing an FL image of the target on a screen of an imaging device. The FL image may be captured in a light-blocking environment with a drape.

[0116] 13A-13C show an exemplary imaging device 400 that may be used with some of the drape embodiments disclosed herein. The imaging device 400 is a portable handheld device that does not require contact with the patient to acquire white light or FL images / videos of the patient's target site. As discussed above, in some examples, the target is a wound on the patient. The operator of the imaging device 400 does not need to wear eye or skin protection when operating the device. The imaging device 400 may be used to capture real-time images / videos. The device includes a pulsed laser-based range finder to determine the optimal distance between the device and the target site for better image quality. The device does not require the use of exogenous imaging contrast agents to acquire FL images / videos.

[0117] As described below, the imaging device 400 includes a portion having a lens and at least one violet light source. The connecting element 50 / 501 is configured to surround an area surrounding the lens and the at least one light source to align the light source within the interior space of the drape body.

[0118] 13A, imaging device 400 includes a power button 410 and a display screen 430 on a body 420. A heat sink 445 is disposed on the body 420 and is used to dissipate heat during use of the device.

[0119] As shown on the back side of the imaging device 400 in FIG. 13B, the body 420 includes an illumination zone 429 with one or more excitation light source LEDs 440 to provide illumination when the device is in FL imaging mode. In some embodiments, the illumination zone 429 includes two violet LEDs configured to provide excitation light at about 405 nm. During FL imaging, the excitation light provides high resolution and realistic imaging of bacteria and tissue components contained within the wound. To perform fluorescence imaging of time, the LED 400 is directed to and illuminates an imaging target, such as a wound and surrounding skin. When illuminated with excitation light, bacteria and tissue components in the wound fluoresce without the need for contrast agents, and the imaging device captures the fluorescence signals emitted by the bacteria and tissue components. When the wound is illuminated with 405 nm excitation light, for example, from the LED 440, collagen in the connective tissue matrix emits a green fluorescence signal, and some bacteria emit a red fluorescence signal due to the production of endogenous porphyrins, while other bacteria emit a cyan fluorescence signal due to the production of endogenous pyoverdine. The imaging device 400 can simultaneously capture the fluorescence from bacteria and other tissues to create a composite image on the display screen 430. A user can easily and instantly visualize the presence and location of bacteria in and around the patient's wound.

[0120] The LEDs 440 are configured to generate excitation light for illuminating a target within a patient to reveal a light signal (e.g., fluorescence) to be imaged, for example, in violet or blue light (e.g., 400-450 nm) or other combination of single or multiple wavelengths (e.g., wavelengths in the ultraviolet / visible / near infrared / infrared range). The LEDs 440 are configured to generate light having wavelengths of about 400 nm to about 450 nm, about 450 nm to about 500 nm, about 500 nm to about 550 nm, about 600 nm to about 650 nm, about 650 nm to about 700 nm, about 700 nm to about 750 nm, and about 750 nm to about 900 nm. In some embodiments, the LEDs 440 are LED arrays of various geometric shapes, laser diodes, and / or filtered light.

[0121] As shown in FIG. 13B, the illumination zone 429 may also include a lens that directs the fluorescent signal emitted by the target to a filter and then to an image sensor included in the body of the imaging device. The image sensor provides image and video capture of both the fluorescent and white light signals. The illumination zone 429 (also known as the imaging head or optical head) may include a flash for white light imaging. The illumination zone 429 is press-fit or snap-fit ​​positioned into an opening in the connection element of the imaging drape and may be further secured by a clamp, clip or other fastening element as discussed above. When aligned within the opening of the drape via the connection element, the lens of the illumination zone can direct the fluorescent signal emitted by the imaging target to the image sensor to capture white light and / or FL images / video.

[0122] The body 420 of the imaging device 400 may include a switch 450 for switching between white light and FL imaging modes. The body 420 may also include a gripping contour 425 that allows a user to easily grip the device during use. In some embodiments, the body 420 may have a charging port 470 that allows the device to be charged with a power cable.

[0123] The imaging device 400 may also include one or more sensors 480, such as a rangefinder sensor for detecting the optimal distance from the wound and an ambient light sensor for detecting optimal lighting conditions for the FL imaging mode.

[0124] The front side of the imaging device 400 may include status indicators 427 that indicate the overall performance status of the device, the battery charge status, the optimal distance from the wound, and the optimal lighting environment for the FL imaging mode.

[0125] The imaging device 400 may also include one or more optical filters (not shown) for filtering out undesired wavelengths. Additionally, the imaging device 400 may include a rechargeable battery (not shown).

[0126] The imaging device may be used to instantly visualize the presence of potentially harmful bacteria commonly found in or around wounds, including Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, coagulase-negative Staphylococcus, Enterococcus spp., Proteus spp., Klebsiella pneumoniae, beta-hemolytic streptococci (group B), and Enterobacter spp. The bacteria may be visualized by the imaging device 400 during clinical assessment of the wound, treatment, and / or monitoring of wound response treatment.

[0127] As discussed above, the imaging device 400 may be used with the drapes disclosed herein to obtain white light and / or FL images / videos. During use, the imaging device 400 should be held approximately 8-12 cm away from the wound. Thus, the device does not need to come into contact with the patient during operation. The range finder sensor may be green when the distance between the device and the wound is optimal. Additionally, the imaging device 400 should be held such that the plane of the wound is approximately parallel to the plane of the device.

[0128] Various components of imaging device 400 may be incorporated into other imaging devices disclosed herein, such as the imaging devices of FIGS. 12G, 12H, 12I, and 14.

[0129] 14 illustrates another embodiment of an imaging device that may be used with various exemplary embodiments of the drapes disclosed herein. The imaging device 4000 includes a body 4200 having a first end portion 4112 and a second end portion 4114. The first end portion 4112 is sized and shaped to be held in one hand by a user of the device. The first end portion 4112 may include a control device 4130 configured to operate the device, switch and / or otherwise control different light sources, and switch between one or more optical imaging filters. Such controls may include buttons, switches, capacitive discharge sensors, or other devices operated by a user.

[0130] The second end portion 4114 of the imaging device 4000 may be tapered and / or extended to facilitate insertion of the distal end or tip 4116 of the second end portion into a surgical wound of 2-3 cm in size and into a patient's resection cavity after a tumor or cancerous tissue has been removed, for example, during breast cancer surgery. The second end portion 4114 may be rigid and aligned at an angle to the first end portion 4112 to facilitate better access under the skin flap, or may be configured to be flexible to facilitate imaging of resection cavities of complex geometry.

[0131] The distal end 4116 includes one or more light sources, such as light emitting diodes (LEDs), configured to emit light having a particular wavelength, as discussed above. The distal end 4116 may also include a camera sensor having a lens and one or more optical filters, as discussed above. In the imaging device 4000, the excitation light source may be configured to fluoresce porphyrins in tumor cells. When illuminated with 405 nm excitation light, the porphyrins, and therefore the tumor cells, emit red fluorescence. Porphyrins in tumor cells and other cancerous tissues may be induced by administering a compound such as 5-ALA to the patient prior to surgery. In addition to being used to inspect the resection cavity, the imaging device 4000 may also be used with tissue specimens excised during surgery. While the specimen undergoes FL imaging, an imaging drape may be attached to the imaging device to align the excised tissue in the light-shielded portable imaging environment. The imaging device may have other excitation light sources with different wavelengths that may also be used with an imaging drape according to the present disclosure.

[0132] Imaging devices and drapes according to various embodiments disclosed herein may be used with a sterile shield 5000 to provide a sterile surgical interface between a non-sterile imaging device contained within the shield and a sterile surgical interface. The shield 5000 may provide a barrier between the sterile field, such as a sterile field inside an operating room, and a non-sterile device that is fully contained within the shield 5000. Thus, the shield 5000 may be a surgical drape that exposes the sterile environment and thereby contains the non-sterile environment.

[0133] Figure 15B shows the shield 5000 positioned over the imaging device 4000, and Figure 15A is a cross-sectional view showing a distal end portion of the imaging device with the shield positioned thereon. Although Figures 15A and 15B show the shield 5000 as being used with the imaging device 4000, it is contemplated that the shield 5000 may be used with any of the imaging devices disclosed herein, as well as with other devices, and may be shaped to correspond to any device with which it is used.

[0134] When placed over the imaging device, the shield 5000 may extend from a proximal end to a distal end of the device, for example, from a first end portion 4112 to a second end portion 4114 of the imaging device. The proximal portion of the shield 5000 may include a closure mechanism for securing the shield 5000 onto the imaging device. The shield 5000 may include a polymeric material, such as polyethylene, polyurethane, or other polymeric material. In some embodiments, the shield 5000 is transparent so that a user can see the imaging device through the shield 5000.

[0135] 15B, the shield 5000 may be shaped to fit and conform to the contours of the imaging device. The shield 5000 may be coupled and placed over the imaging device before the imaging device is attached to the imaging drape.

[0136] 15A shows a distal end portion of the shield 5000 including a distal end cap 5010 connected to a distal end of the polymeric material of the shield 5000. The distal end cap 5010 may be a lens formed of a plastic material such as, for example, acrylic or polycarbonate so as not to affect the optics of the imaging device 4000. In some embodiments, the distal end cap 5010 is welded to the polymeric material of the shield 5000. Additionally, the distal end cap 5010 may be transparent, similar to the polymeric material of the shield 5000. Thus, FL and / or white light emitted from the imaging device may pass through the transparent lens of the distal end cap 5010 to the interior environment of the drape.

[0137] FIG. 15C illustrates an exemplary embodiment in which a shield 5000 is placed over an imaging device and the device is coupled to a drape for imaging a patient using FL and / or white light imaging. The drape in FIG. 15C may be any of the drape embodiments disclosed herein. As shown in FIGS. 15A-16D, the drape and shield may each have a mating retention feature for coupling the imaging device to the drape. In some embodiments, the distal cap 5010 includes a connection element 5020 configured to mate with a support ring on a connection element on the drape, as described in more detail below. The mating connection between the connection element 5020 and the support ring may provide a secure attachment between the imaging device and the drape and may reduce / prevent all light from entering the interior of the drape. As shown in FIGS. 15A and 16A, the connection element 5020 may be a recess in the distal cap 5010. For example, the connection element 5020 may be a circumferential groove in the distal cap 5010. In some embodiments, the connecting element 5020 may be a breakable member configured to initially break when the imaging device is separated from the drape. As will be described in more detail below, this frangible feature of the connecting element 5020 may prevent reuse of the shield.

[0138] The distal cap 5000 helps guide the connection of the shield 5000 to the drape. 15A, the indicator feature 5030 may be a recess in the distal cap 5010. The indicator feature 5030 may be used to properly align the drape and the imaging device. Thus, the indicator feature 5030 may be used as an indication to a user not to place drape material proximal to the indicator feature 5030. For example, the indicator feature 5030 may be a circumferential groove in the distal cap 5010.

[0139] The retention feature on the drape may be a connection element 5500, as shown in FIG. 16B. The connection element 5500 may include a mount 5510 that is attached to the drape body. The mount 5510 may be welded to the drape or attached via adhesive, tape, Velcro, staples, etc. A support ring 5520 may extend outwardly from the mount 5510. One or more side walls 5530 may brace the support ring 5520 on the mount 5510. An aperture 5333 may be defined in the mount 5510 such that the aperture 5333 is bordered by the side walls 5530. The aperture 5333 may be aligned with the aperture 133 on the drape, as discussed above. When the imaging device is secured to the drape, at least a portion of the distal end cap 5010 may be disposed within the aperture 5333.

[0140] The connecting element 5020 on the shield 5000 may be configured to mate with a support ring 5520 on the connecting element 5500 to secure the imaging device to the drape. The support ring 5520 may thus be configured to nest within a circumferential groove of the connecting element 5020 to securely fasten the imaging device to the drape. In some embodiments, the connecting element 5020 and the support ring 5520 form a male-female locking mechanism. It is also contemplated that these components may be coupled together via an interference fit.

[0141] FIG. 16C shows the connection element 5020 and the support ring 5520 interacting to secure the imaging device to the drape. This may allow the imaging device to take FL and / or white light images within the light-shielded interior environment of the drape, as discussed above. When the imaging device is removed from the drape and detached, the shield breaks at the connection element 5020. For example, when the imaging device is detached from the drape, the connection element 5020 bends on the support ring 5520. This bending causes the connection element 5020 to break. Thus, the distal end cap 5010 is separated from the rest of the shield at the connection element 5020. The connection element 5020 is configured to break first when the imaging device is removed from the drape, since it is a groove / recess in the shield. However, it is also contemplated that the connection element 5020 may be a weakened or thinner piece of material on the shield, providing this component with a breakable nature. Separating the distal end cap 5020 from the remainder of the shield prevents the shield from being reused.

[0142] 16B, the connecting element 5500 does not include protrusions that would prevent the material of the drape from collapsing into the field of view. In this embodiment, the connecting element 5500 may be used with smaller drapes that do not have excess material that can inadvertently move into the field of view.

[0143] For purposes of this specification and the appended claims, unless otherwise indicated, all numerical values ​​expressing quantities, percentages or proportions, and other numerical values ​​used in the specification and claims, unless they are already so modified, are to be understood as being modified in all instances by the term "about." Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and the appended claims are to be understood as being modified in all instances by the term "about." are approximations that may vary depending on the desired properties to be obtained. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

[0144] Furthermore, the terms used herein are not intended to limit the disclosure. For example, spatially relative terms such as "beneath," "below," "lower," "above," "upper," "proximal," "distal," and the like may be used to describe the relationship of one element or feature to another element or feature as depicted in the figures. These spatially relative terms are intended to encompass various positions (i.e., locations) and orientations (i.e., rotational configurations) of the device in use or operation in addition to the depicted positions and orientations. For example, if a device in the figures is turned over, elements described as "below" or "beneath" other elements or features would become "above" or "over" the other elements or features. Thus, the exemplary term "below" can encompass both above and below positions and orientations. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein may be interpreted accordingly. Similarly, descriptions of motion along and about various axes include various particular positions and orientations of the device. Additionally, the singular articles "a," "an" and "it" are intended to encompass the plural unless the context indicates otherwise. Additionally, the terms "comprise," "include," and similar terms specify the presence of stated features, steps, operations, elements and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components and / or groups. Components described as being coupled may be directly coupled electrically or mechanically or indirectly coupled through one or more intermediate components.Mathematical and geometric terms are not necessarily intended to be used according to their precise definitions, unless the context of the description dictates otherwise, because one of ordinary skill in the art will understand that, for example, substantially similar elements that function in a substantially similar manner may readily fall within the scope of a descriptive term even if the term itself has a precise definition.

[0145] One of ordinary skill in the art will appreciate that embodiments of the present disclosure contemplate a variety of mechanisms encompassing various structural features for the material of the drape, the shaping elements of the drape, and the connecting elements for connecting the drape to a portable handheld imaging device, although other materials and / or structures may be used for these mechanisms as will become apparent upon reading this disclosure without departing from the scope of the present disclosure.

[0146] Furthermore, the devices and methods may include additional components or steps that are omitted from the drawings for clarity of illustration and / or operation. Thus, this specification text should be construed as merely illustrative and is intended to teach those skilled in the art the general manner of carrying out the present disclosure. It is to be understood that the various embodiments shown and described herein are to be construed as illustrative. Elements and materials, and the arrangements of these elements and materials, may be substituted for those illustrated and described herein, parts and processes may be reversed, and certain features of the present disclosure may be utilized independently, all as would be apparent to one skilled in the art after having the benefit of the description herein. No modification of the elements described herein may be made without departing from the spirit and scope of the present disclosure and the claims, including equivalents thereof. Modifications may be made without

[0147] It is to be understood that the specific examples and embodiments described herein are non-limiting, and that changes in structure, dimensions, materials, and methodologies may be made without departing from the scope of the present disclosure.

[0148] Although the present disclosure has been described in detail with respect to various exemplary embodiments thereof, it is to be understood that the disclosure should not be considered as being limited thereto, and thus many modifications are possible without departing from the broad scope of the appended claims, including equivalents encompassed therein.

Claims

1. A drape, a drape body configured to restrict electromagnetic radiation from passing through the drape body to the internal imaging environment defined by the drape body such that electromagnetic radiation in the internal imaging environment does not exceed a predetermined threshold; a connection element permanently coupled to the drape body and defining an aperture in the drape body, the connection element configured to attach the drape to an imaging device.

2. The drape of claim 1 , wherein the amount of electromagnetic radiation above the predetermined threshold is an amount of electromagnetic radiation known to interfere with fluorescent and white light imaging.

3. The drape of claim 1 or claim 2, wherein the connection element further comprises at least one support structure.

4. The drape of claim 3 , wherein the at least one support structure is aligned on an inner surface of the drape.

5. 5. The drape of claim 3 or claim 4, wherein the at least one support structure is configured to support a portion of the drape body surrounding the connection element such that, when the drape is in an unfolded configuration, a portion of the drape extends planarly from the connection element to a first forming structure of the drape.

6. The drape of any one of claims 3 to 5, wherein the at least one support structure comprises a plurality of support structures.

7. The drape according to any one of claims 3 to 6, wherein the plurality of support structures extend radially outwardly or circumferentially from a frame of the connection element.

8. The drape of any one of claims 3 to 7, wherein the at least one support structure is a finger element.

9. The drape of claim 8 , wherein the at least one support structure comprises a plurality of finger elements extending from a frame of the connecting element.

10. The drape of any one of claims 3 to 9, wherein the at least one support structure is flexible.

11. The drape of any one of claims 5 to 10, wherein the portion of the drape body that extends to the first shaping element is generally circular.

12. The drape of any one of claims 5 to 11, wherein the first shaping element is a soft structure embedded in the drape body.

13. The drape of any one of claims 5 to 12, wherein the first shaping element is configured to maintain the shape of the drape body in the deployed configuration.

14. The first shaping element cooperates with the at least one support structure to urge the drain. The drape of any one of claims 5 to 13, configured to keep a drape body out of the field of view of the imaging device.

15. The drape of any one of claims 5 to 14, wherein the first shaping element is further configured to change the shape of the drape in response to user manipulation and to maintain the shape change after release by the user.

16. The drape of any one of claims 1 to 15, further comprising at least one valve configured to allow air to enter the drape during deployment of the drape.

17. 17. The drape of claim 16, wherein the at least one valve is a one-way valve configured to prevent air from escaping from the interior imaging environment after deployment of the drape.

18. The drape of any one of claims 1 to 17, wherein the drape has a generally circular shape in the undeployed configuration.

19. The drape of claim 18 , wherein the drape has a generally cylindrical shape in the deployed configuration.

20. The drape of claim 18 , wherein the drape has a frusto-conical shape in the deployed configuration.

21. The drape of any one of claims 5 to 20, further comprising a second shaping element.

22. 22. The drape of claim 21, wherein the second shaping element has a generally circular shape.

23. 23. The drape of claim 22, wherein the second shaping element is aligned radially outward from the first shaping element when the drape is in the undeployed configuration.

24. The drape of any one of claims 1 to 23, wherein the connecting element comprises a frame.

25. The drape of claim 24 , wherein holes in the drape body are formed in the frame of the connecting element.

26. 26. The drape of claim 25, wherein the frame is generally rectangular in shape.

27. The drape of any one of claims 1 to 26, wherein an aperture in the drape body is shaped and sized to receive a portion of the imaging device including a light source and a lens.

28. 28. The drape of claim 27, wherein the apertures are generally kidney-shaped.

29. The drape of any one of claims 1 to 28, wherein the connection element further comprises a clip configured for attachment to the imaging device.

30. 30. The drawer of claim 29, wherein the clip is movable between an open position and a closed position. P.S.

31. The drape of claim 30, further comprising a cover portion configured to be positioned between an aperture in the drape body and the clip.

32. The drape of claim 31 , wherein the clip is configured to move to the open position during removal of the cover portion.

33. The drape of any one of claims 1 to 32, wherein when in a deployed configuration, the drape includes a top portion extending generally radially around the connection element and a skirt portion extending perpendicularly from an outer periphery of the top portion of the drape.

34. The drape of claim 33, wherein the skirt portion is flexible.

35. The drape of claim 33, wherein the skirt portion is generally rigid.

36. A drape as described in any one of claims 33 to 36, wherein the bottom of the skirt portion includes one or more fixation elements configured to fix the bottom of the skirt portion of the drape relative to the area to be imaged such that the area to be imaged is aligned or contained within the internal imaging environment of the drape.

37. 37. The drape of claim 36, wherein the one or more fastening elements include at least one of a weighted element, a magnet, a drawstring, a tape, a wire, and a hook and loop closure.

38. The drape of any one of claims 1 to 37, wherein the drape comprises at least one of a plastic material, a paper material, a vinyl material, and a cloth material.

39. 40. The drape of claim 38, wherein the drape further comprises a coating configured to limit the passage of electromagnetic radiation.

40. 40. The drape of claim 38 or claim 39, wherein an inner surface of the drape that defines the internal imaging environment is coated with a material that reduces reflections within the internal imaging environment.

41. 1. A system for fluorescence-based imaging of a target, comprising: The drape of claim 1; a portable handheld imaging device, the imaging device including a portion having a lens and at least one purple light source, the connecting element configured to surround an area surrounding the lens and the at least one light source to align the light source within an interior space of the drape body.

42. 42. The system of claim 41, further comprising a shield disposed over the imaging device.

43. 43. The system of claim 42, wherein the shield is a polymeric material.

44. A drape, A drape body configured to move between a closed configuration and an open configuration, the drape body being generally flat in the closed configuration, and in the open configuration, the drape body having a shape that is generally cylindrical, generally rectangular, a truncated cone, or a truncated pyramid. and, a connecting element coupled to the drape body and configured to attach the drape to a portable handheld imaging device; at least one valve configured to admit air to the drape as the drape moves from the closed configuration to the open configuration.

45. 43. The drape of claim 42, further comprising at least one shaping element configured to hold the drape in the open configuration.

46. 44. The drape of claim 43, wherein the at least one shaping element is configured to keep the drape out of the field of view of an imaging device connected to the drape when the drape is in an open configuration.

47. 45. The drape of claim 43 or claim 44, wherein the at least one shaping element is configured to maintain the drape in the closed configuration prior to deployment of the drape into the open configuration.

48. The drape of any one of claims 43 to 45, wherein the at least one shaping element comprises a plurality of shaping elements.

49. The drape of any one of claims 43 to 46, wherein the plurality of shaping elements are configured to allow a user to alter the shape of the drape when in the open configuration.

50. 48. The drape of claim 47, wherein a shape of the drape can be configured to match a shape of a portion to be imaged.

51. 49. The drape of claim 48, wherein the plurality of shaping elements maintain the drape in the altered shape.

52. The drape of any one of claims 43 to 49, wherein the at least one shaping element is a wire.

53. 51. The drape of claim 50, wherein the wire is embedded in the drape body.

54. The drape of any one of claims 43 to 51, wherein the connection element comprises a frame portion having an opening configured to receive a portion of the imaging device, and a plurality of connectors configured to removably engage the imaging device.

55. 53. The drape of claim 52, wherein the opening is configured to sealingly engage the imaging device to prevent electromagnetic radiation from passing through the opening to an interior of the drape.

56. A drape according to any one of claims 43 to 53, wherein the drape comprises a material configured to restrict the passage of electromagnetic radiation through the drape body to create an imaging environment within the drape.

57. The drape of any one of claims 42 to 54, wherein the inner surface of the drape is sterile.

58. The drape of any one of claims 42 to 55, wherein the drape comprises a black material.

59. The drape of any one of claims 42 to 56, wherein the drape comprises at least one of a plastic material, a cloth material, a vinyl material, a rubber material, and a paper material.

60. 58. The drape of claim 57, wherein the drape comprises a plastic film.

61. 59. The drape of claim 58, wherein the drape comprises a polyethylene or polyolefin film.

62. The drape of any one of claims 42 to 59, wherein an inner surface of the drape has a matte finish.

63. A drape according to any one of claims 42 to 60, wherein an inner surface of the drape forms a non-reflective surface.

64. The drape of any one of claims 42 to 61, wherein the drape body is substantially rigid when the drape is in the open configuration.

65. The drape according to any one of claims 42 to 61, wherein the drape body is soft when the drape is in the open structure.

66. 1. A method for creating a portable imaging environment, comprising: aligning a portable handheld imaging device with an opening in a light drape while the drape is in a folded position; connecting a frame of the drape to the imaging device; and moving the imaging device and connected drape away from a packaging element that supports the drape in the folded state.

67. 65. The method of claim 64, wherein moving the imaging device and the connected drape away from the packaging element includes passing air to an interior of the drape through at least one vent in the drape.

68. 66. The method of claim 64 or claim 65, wherein aligning the imaging device with an opening in a light-shielding drape includes creating a seal between a portion of the imaging device and the opening in the drape to restrict electromagnetic radiation from entering an interior of the drape through the opening.

69. The method of any one of claims 64 to 66, wherein connecting the frame of the drape to the imaging device comprises fixing one or more connectors of the frame to the imaging device.

70. 68. The method of any one of claims 64 to 67, wherein moving the imaging device and the connected drape away from the packaging element comprises expanding the drape from the collapsed state to an expanded state.

71. Expanding the drape from the folded state to the expanded state can include expanding the drape from a generally flat shape to a generally cylindrical shape, a generally rectangular shape, a frustum cone shape, and a frustum pyramid shape.

69. The method of claim 68, comprising moving the

72. 70. The method of claim 68 or claim 69, wherein expanding the drape from the folded state to the expanded state comprises moving the drape away from the packaging element until at least one shaping element of the drape disengages from the packaging element.

73. 71. The method of claim 70, wherein expanding the drape from the folded state to the expanded state comprises moving the drape away from the packaging element until a plurality of shaping elements of the drape disengage from the packaging element.

74. 72. The method of claim 71, wherein the plurality of molding elements are released from the packaging element in succession.

75. 72. The method of claim 71, wherein the molding elements disengage from the packaging element substantially simultaneously.

76. The method of any one of claims 64 to 73, further comprising aligning the extended drape over the portion to be imaged.

77. The method of any one of claims 64 to 74, further comprising adjusting a shape of the drape to conform to the portion to be imaged.

78. 76. The method of claim 75, wherein adjusting the shape of the drape to conform comprises manipulating at least one shaping element of the drape to conform to a contour of the portion to be imaged.

79. 77. The method of any one of claims 64 to 76, further comprising supporting a portion of the drape surrounding the opening when the drape is in an expanded state to maintain the portion of the drape outside the field of view of the imaging device.

80. 78. The method of any one of claims 64 to 77, further comprising draping a bottom portion of the drape around the portion to be imaged such that the bottom of the drape limits the passage of electromagnetic radiation into an interior space defined by the extended drape, the interior space forming a light-tight imaging environment.

81. A method according to any one of claims 64 to 78, further comprising using the imaging device to obtain a fluorescent image or video of the portion to be imaged in the light-shielded imaging environment.

82. A method according to any one of claims 64 to 79, further comprising using the imaging device to capture a white light image or a white light video of the portion to be imaged within the light-shielded imaging environment.

83. 1. A method for acquiring fluorescence-based images or videos without varying ambient lighting conditions, comprising: removing a cover from an opening in a blackout drape; attaching an imaging device to the drape while the drape is connected to a packaging element; removing the imaging device and the attached drape from the package element; and moving the drape apart to unfold the drape. aligning an open bottom end of the drape over a body part to be imaged; creating a light-shielded imaging environment around the body part to be imaged by contouring a portion of the drape around the body part to be imaged, the drape being configured to limit the passage of ambient light through the drape and into the light-shielded imaging environment; and capturing a fluorescent image or video of the body part with the imaging device attached to the drape.

84. 82. The method of claim 81, further comprising verifying with a sensor of the imaging device that the light-shielded imaging environment within the drape meets fluorescent imaging requirements.

85. 83. The method of claim 81 or claim 82, wherein removal of a cover from an opening in a light-shielding drape moves one or more connection mechanisms to an open position to receive the imaging device while maintaining a sterile interior of the drape.

86. The method of any one of claims 81 to 83, wherein attaching an imaging device to the drape while the drape is connected to a packaging element comprises aligning a lens portion of the imaging device with a hole in the drape, the hole being formed in a connection frame of the drape.

87. 85. The method of claim 84, wherein attaching an imaging device to the drape while the drape is connected to a packaging element further comprises sealingly attaching a lens portion of the imaging device to the connecting frame in a manner that prevents ambient light from passing through holes in the drape.

88. 86. The method of any one of claims 81 to 85, wherein capturing a fluorescent image or video of the body part with the imaging device attached to the drape comprises illuminating the body part to be imaged with light from at least one violet LED.

89. 87. The method of claim 86, wherein the at least one purple LED is aligned with a lens portion of the imaging device that is aligned with a hole in the drape.

90. A method according to any one of claims 81 to 87, further comprising maintaining a clear field of view of the imaging device during imaging.

91. 90. The method of claim 88, wherein maintaining a clear field of view includes supporting an area of ​​the drape surrounding a hole in the drape to keep the field of view clear.

92. 90. The method of claim 88 or claim 89, wherein maintaining a clear field of vision includes supporting at least one point along a length, circumference or perimeter of the drape to keep the field of vision clear.

93. 90. The method of claim 89, wherein supporting the area of ​​the drape surrounding the hole in the drape includes supporting the drape with a plurality of support elements extending radially from the connection frame.

94. Supporting the circumference or periphery of the drape along the length of the drape may 91. The method of claim 90, comprising supporting the circumference or periphery of the drape with a flexible element embedded around the periphery of the drape.

95. 93. The method of claim 92, wherein the soft element embedded around the circumference is at least one wire.

96. 94. The method of any one of claims 81 to 93, further comprising removing the drape from the body part following capturing a fluorescent image or video of the body part with the imaging device attached to the drape.

97. 95. The method of claim 94, further comprising removing the imaging device from the drape.

98. 96. The method of claim 95, wherein removing the imaging device from the drape includes releasing one or more connection mechanisms connected to a body of the imaging device.

99. The method of any one of claims 81 to 94, further comprising capturing a white light image or white light video of the body part with the imaging device attached to the drape.

100. 1. A dispensing element configured to store a light-blocking drape, comprising: A substantially flat base portion; and at least one restraining element configured to engage a shaping element of the shade drape.

101. 100. The dispensing element of claim 98, wherein the at least one restraining element is aligned with a center of the flat base portion.

102. 100. A dispensing element according to claim 98 or claim 99, wherein the at least one restraining element has a height that extends upwardly from the flat base portion.

103. A dispensing element according to any one of claims 98 to 100, wherein the at least one restraining element is a ring extending upwardly from the flat base portion.

104. A dispensing element according to any one of claims 98 to 101, wherein the at least one constraint element comprises at least two constraint elements, the at least two constraint elements being concentrically aligned on the flat base portion.

105. A dispensing element according to any one of claims 98 to 102, wherein the at least one constraining element is a ring, the ring being circular or polygonal in shape.

106. A dispensing element according to any one of claims 98 to 103, wherein the flat base portion is formed from cardboard, rubber or plastic.

107. A dispensing element according to any one of claims 98 to 104, wherein the at least one restraining element is formed from cardboard, plastic or rubber.

108. Shade drape comprising a shade drape and a drape-dispensing element 1. A system comprising: The light-shielding drape comprises: a drape body configured to limit the passage of ambient light through the drape body to an internal imaging environment defined by the drape body; a frame configured to attach the drape to an imaging device; at least one shaping element configured to maintain the drape out of the field of view of the imaging device during imaging; The drape-dispensing element comprises: A substantially flat base portion; at least one restraining element configured to engage the at least one shaping element of the shade drape.

109. 107. The system of claim 106, wherein an interior of the drape body is kept sterile relative to a base portion of the dispensing element.

110. 108. The system of claim 106 or claim 107, wherein the at least one shaping element of the drape is a wire, the wire having a circular or polygonal shape.

111. 109. The system of claim 108, wherein the at least one restraining element is a ring element, the ring element having a circular or polygonal shape.

112. A system according to any one of claims 106 to 109, wherein the at least one shaping element is configured to fit within the at least one constraining element.

113. 111. The system of claim 110, wherein the drape comprises at least two shaping elements and the dispensing element comprises at least two restraining elements, the restraining elements being concentrically aligned onto a base portion of the dispensing element.

114. 112. The system of claim 110 or claim 111, wherein each of the two shaping elements and each of the two restraining elements are circular in shape.

115. 112. The system of claim 110 or claim 111, wherein each of the two shaping elements and each of the two restraining elements are polygonal in shape.

116. A system according to any one of claims 106 to 109, wherein the at least one restraining element is configured to fit within the at least one shaping element.

117. 115. The system of claim 114, wherein the drape comprises at least two shaping elements and the dispensing element comprises at least two restraining elements, the restraining elements being concentrically aligned onto a base portion of the dispensing element.

118. 116. The system of claim 114 or claim 115, wherein each of the two shaping elements and each of the two restraining elements are circular in shape.

119. 116. The system of claim 114 or claim 115, wherein each of the two shaping elements and each of the two restraining elements are polygonal in shape.

120. The system of any one of claims 106 to 117, wherein at least one shaping element of the drape and at least one restraining element of the dispensing element are configured to cooperate to facilitate deployment of the drape.

121. 119. The system of claim 118, wherein the drape further comprises at least one vent configured to prevent a vacuum from being created within the drape as the drape is pulled away from the base portion of the dispensing element.

122. The system of any one of claims 106 to 119, wherein the drape body is further configured to limit electromagnetic radiation other than ambient light from passing through the drape body to the internal imaging environment defined by the drape body.

123. The system of any one of claims 106 to 120, wherein the drape comprises at least one of a plastic material, a rubber material, a paper material, a vinyl material, and a cloth material.

124. 1. A method for obtaining measurements of a target without varying ambient light conditions, comprising: removing a cover from an opening in a blackout drape; attaching an imaging device to the drape while the drape is connected to a packaging element; moving the imaging device and the attached drape away from the packaging element and unfolding the drape; positioning the open bottom end of the drape over a body part containing the target to be measured; contouring a portion of the drape around the body part including the target to be imaged to create a light-tight environment around the body part including the target to be measured, the drape being configured to limit the passage of electromagnetic radiation through the drape and into the light-tight environment; and measuring the target on the body part with a portable handheld imaging device attached to the drape.

125. 123. The method of claim 122, wherein the target is a wound, a lesion, a cut, an incision, or a tumor.

126. 124. The method of claim 122 or claim 123, wherein measuring the target includes viewing a white light image of the target on a screen of the imaging device.

127. The method of any one of claims 122 to 124, further comprising capturing a white light image of the target while the body part is in the light-blocking environment.

128. The method of any one of claims 122 to 125, further comprising capturing a fluorescent image of the target while the body part is in the light-tight environment.

129. The drape of any one of claims 1 to 41, wherein the drape is configured for single use and is therefore disposable.

130. The drape of any one of claims 41 to 63, wherein the drape is configured for single use and is therefore disposable.

131. A drape, a drape body configured to limit the passage of ambient light through the drape body to an internal imaging environment defined by the drape body; a connection element coupled to the drape body and defining a hole in the drape body, the connection element including a plane and fingers projecting outwardly from the plane, the fingers configured to attach the drape to an imaging device.

132. A drape, a drape body configured to limit the passage of ambient light through the drape body to an internal imaging environment defined by the drape body; a retention feature coupled to the drape body and configured to attach the drape to an imaging device.

133. 133. The drape of claim 132, wherein the retention feature further comprises a support ring.

134. 134. The drape of claim 133, wherein the retention features are aligned with an outer surface of the drape.

135. The drape of any one of claims 132 to 134, wherein the retention feature is configured to mate with a circumferential groove on the imaging device.

136. The drape of any one of claims 132 to 135, wherein the retention feature defines an opening in the drape.

137. The drape of any one of claims 132 to 136, wherein the retention feature extends radially outward from the drape.

138. The drape according to any one of claims 132 to 137, wherein the drape comprises at least one of a plastic material, a paper material, a vinyl material, and a cloth material.

139. 139. The drape of claim 138, wherein the drape further comprises a coating configured to limit the passage of electromagnetic radiation.

140. 140. The drape of claim 138 or claim 139, wherein an inner surface of the drape that defines the internal imaging environment is coated with a material that reduces reflections within the internal imaging environment.

141. 1. A system for fluorescence-based imaging of a target, comprising:

133. The drape of claim 132; a portable handheld imaging device, the imaging device including a portion having a lens and at least one purple light source, the connecting element configured to surround an area surrounding the lens and the at least one light source to align the light source within an interior space of the drape body.

142. An imaging drape, a drape body configured to limit the passage of ambient light through the drape body into a portable imaging environment defined by the drape body or to change a characteristic of ambient light passing through the drape body into the portable imaging environment; A drape body, a connecting element configured to attach the drape to an imaging device; and at least one shaping element configured to maintain the drape out of a field of view of the imaging device during imaging.

143. An imaging drape, a drape body defining a portable imaging environment, the drape body being configured to reduce ambient and / or visible light in the portable imaging environment by approximately 402 mW / m ２ The imaging drape is configured to restrict the imaging area to less than 100 nm.

144. 144. The drape of claim 143, further comprising a connecting element configured to attach the drape to an imaging device.

145. 145. The drape of claim 144, wherein the connecting element comprises a support ring projecting radially outward from a top surface of the drape body.

146. 146. The drape of claim 145, wherein the support ring is configured to be coupled with a shield that is placed over the imaging device to attach the drape to the imaging device.

147. 147. The drape of claim 146, wherein the support ring is configured to be coupled to the shield via a male-female locking mechanism.

148. A drape as described in any one of claims 144 to 146, wherein the connection element comprises one or more protrusions configured to prevent the drape body from moving into the imaging environment when the drape is in an deployed configuration.

149. The drape of any one of claims 144 to 147, wherein the connection element comprises a gripping element configured to secure the imaging device to the drape.

150. 150. The drape of claim 149, wherein the gripping elements are configured to rotate within a range of motion of approximately 90 degrees from an open configuration to a closed configuration.

151. A drape as described in any one of claims 144 to 150, wherein the connection element comprises a one-way valve configured to provide air movement from outside the drape to inside the drape to create a higher air pressure inside the drape than outside the drape.

152. A drape according to any one of claims 143 to 151, further comprising at least one shaping element configured to maintain the drape in a position outside the field of view of the imaging device during imaging.

153. The drape of any one of claims 143 to 152, further comprising a fastening element configured to conform the drape body to the contours of a patient.

154. 154. The drape of claim 153, wherein the fixation element is a magnet configured to be magnetically attracted to a magnet on the patient.

155. The fastening elements may be weighted elements, tapes, wires, hooks and / or 154. The drape of claim 153, which is a loop closure.

156. 154. The drape of claim 153, wherein the fastening element is a drawstring, hook and loop closure, or snap configured to reduce the diameter of the bottom portion of the drape body.

157. The drape of any one of claims 143 to 156, wherein the drape comprises at least one of a plastic material, a paper material, a vinyl material, and a cloth material.

158. 158. The drape of claim 157, further comprising a coating configured to limit the passage of electromagnetic radiation.

159. 159. A drape as described in claim 157 or claim 158, wherein an inner surface of the drape that defines the imaging environment is coated with a material that reduces reflections within the imaging environment.

160. A kit comprising: A drape according to any one of claims 1 to 40, claims 44 to 63, and claims 129 to 159; and a compound configured to induce porphyrins in cancerous tissue cells.

161. 161. The kit of claim 160, wherein the compound is a non-activated, non-targeted contrast agent, a single-mode contrast agent or a multi-modal contrast agent.

162. The kit of claim 161, wherein the compound is 5-aminolevulinic acid.

163. 163. The kit of claim 162, further comprising a portable handheld imaging device.

164. 164. The kit of claim 163, wherein the portable handheld imaging device includes an excitation light source.

165. 165. The kit of claim 164, wherein the excitation light source is configured to emit excitation light having a wavelength between about 400 nm to about 450 nm, about 450 nm to about 500 nm, about 500 nm to about 550 nm, about 600 nm to about 650 nm, about 650 nm to about 700 nm, about 700 nm to about 750 nm, and / or about 750 nm to about 900 nm.

166. 166. The kit of claim 165, wherein the excitation light source is configured to emit excitation light having a wavelength of about 400 nm to about 450 nm.

167. 167. The kit of claim 166, wherein the excitation light source is configured to emit excitation light having a wavelength of approximately 405 nm ± 10 nm.

168. The kit of any one of claims 163 to 167, wherein the handheld imaging device is configured to have a plurality of excitation light sources, each light source configured to emit excitation light having a different wavelength.

169. 169. The kit of claim 168, wherein the handheld imaging device comprises a first excitation light source emitting a first excitation light having a wavelength between about 375 nm and about 430 nm, or about 405 nm, and a second excitation light source emitting a second excitation light having a wavelength between about 550 nm and about 600 nm, or about 572 nm.

170. 170. The kit of claim 169, wherein the handheld imaging device further comprises a third excitation light source emitting a third excitation light having a wavelength between about 700 nm and about 850 nm, between about 760 nm and about 800 nm, or about 760 nm.

171. The kit of any one of claims 163 to 170, wherein the handheld imaging device includes a filter configured to allow signals emitted by bacteria, bacterial components, tissues, tissue components and / or porphyrins induced in cancerous tissue or tumor in response to irradiation with the excitation light to pass through the filter to an image sensor of the handheld imaging device.

172. 172. The kit of claim 171, wherein the filter is configured to allow passage of signals having wavelengths between about 450 nm and about 500 nm, between about 500 nm and about 550 nm, between about 550 nm and about 600 nm, between about 600 nm and about 660 nm, and / or between about 660 nm and about 710 nm.

173. The kit of any one of claims 163 to 172, wherein the handheld imaging device further comprises a white light source for white light imaging.

174. The kit of claim 173, wherein the excitation light source and the lens of the imaging device are aligned on an imaging head of the imaging device.

175. 175. The kit of claim 174, wherein the imaging head further comprises the white light source.

176. The kit of claim 173 or claim 174, wherein the drape includes a connecting element configured to receive the imaging head.

177. 177. The kit of claim 176, wherein the connecting element is configured to sealingly engage the imaging head.

178. A kit comprising: A drape according to any one of claims 1 to 40, claims 44 to 63, and claims 129 to 159; a portable handheld imaging device configured to connect to the drape.

179. 179. The kit of claim 178, wherein the portable handheld imaging device includes an excitation light source.

180. 180. The kit of claim 179, wherein the excitation light source is configured to emit excitation light having a wavelength between about 400 nm to about 450 nm, about 450 nm to about 500 nm, about 500 nm to about 550 nm, about 600 nm to about 650 nm, about 650 nm to about 700 nm, about 700 nm to about 750 nm, and / or about 750 nm to about 900 nm.

181. 181. The kit of claim 180, wherein the excitation light source is configured to emit excitation light having a wavelength of about 400 nm to about 450 nm.

182. 182. The kit of claim 181, wherein the excitation light source is configured to emit excitation light having a wavelength of approximately 405 nm ± 10 nm.

183. The handheld imaging device is configured to have a plurality of excitation light sources, each of the light sources being The kit according to any one of claims 178 to 182, wherein the excitation light sources are configured to emit excitation light having different wavelengths.

184. The kit of claim 183, wherein the handheld imaging device comprises a first excitation light source emitting a first excitation light having a wavelength between about 375 nm and about 430 nm, or about 405 nm, and a second excitation light source emitting a second excitation light having a wavelength between about 550 nm and about 600 nm, or about 572 nm.

185. 185. The kit of claim 184, wherein the handheld imaging device further comprises a third excitation light source emitting a third excitation light having a wavelength between about 700 nm and about 850 nm, between about 760 nm and about 800 nm, or about 760 nm.

186. A kit as described in any one of claims 178 to 185, wherein the handheld imaging device includes a filter configured to allow signals emitted by bacteria, bacterial components, tissue, tissue components and / or porphyrins induced in cancerous tissue or tumor in response to irradiation with the excitation light to pass through the filter to an image sensor of the handheld imaging device.

187. 187. The kit of claim 186, wherein the filter is configured to allow passage of signals having wavelengths between about 450 nm and about 500 nm, between about 500 nm and about 550 nm, between about 550 nm and about 600 nm, between about 600 nm and about 660 nm, and / or between about 660 nm and about 710 nm.

188. The kit of any one of claims 178 to 187, wherein the handheld imaging device further comprises a white light source for white light imaging.

189. The kit of claim 188, wherein the excitation light source and the lens of the imaging device are aligned on an imaging head of the imaging device.

190. 190. The kit of claim 189, wherein the imaging head further comprises the white light source.

191. The kit of claim 189 or claim 190, wherein the drape includes a connecting element configured to receive the imaging head.

192. 192. The kit of claim 191, wherein the connecting element is configured to sealingly engage the imaging head.

193. The kit of any one of claims 178 to 192, further comprising one or more imaging agents.

194. The kit of claim 193, wherein the one or more imaging agents comprise a compound configured to induce porphyrins in cancerous tissue cells.

195. 200. The kit of claim 194, wherein the compound is a non-activated, non-targeted contrast agent, a single-mode contrast agent or a multi-modal contrast agent.

196. The kit of claim 195, wherein the compound is 5-aminolevulinic acid.

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