Related Applications

[0001] This application claims priority from U.S. Provisional Application Nos. 63/011,515, filed April 17, 2020, and 63/028,718, filed May 22, 2020, the disclosures of which are incorporated by reference in their entireties.

Background

[0002] Laparoscopic surgery is a widely-used technique that is performed through keyhole incisions. Compared to traditional surgery, it improves recovery time, leaves smaller scars, and decreases infection. It is the standard of care (SOC) for many operations in high- income countries. However, in low- and middle-income countries (LMICs) the availability can be limited due factors such as lack of resources and supplies and frequent power outages. Conventional laparoscopic devices can further include complex, fragile, and/or expensive components that are difficult to maintain and replace. Hence, there is an ongoing need for improved laparoscopic devices.

Summary

[0003] The Summary is provided to introduce a selection of concepts that are further described below in the Detailed Description. This Summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used as an aid in limiting the scope of the claimed subject matter.

[0004] One aspect of the present disclosure provides a laparoscopic device comprising, consisting of, or consisting essentially of a light source and a visual or image detector. [0005] In some embodiments, the visual detector comprises a CMOS detector.

[0006] In some embodiments, the light source comprises a ring of LEDs disposed at a distal end of the device.

[0007] Another aspect of the present disclosure provides a laparoscope including: an elongated probe including a proximal end and a distal end; a handle at the proximal end of the probe; a tip at the distal end of the probe, the tip including a shelf having first surface facing the distal end of the probe and a second, opposite surface facing the proximal end of the probe; a plurality of LEDs on the first surface of the shelf; and an image detector comprising a lens adjacent the second surface of the shelf.

[0008] In some embodiments: an aperture is defined in the shelf; the image detector lens is adjacent the aperture; and/or the plurality of LEDs are on a ring-shaped substrate that surrounds the aperture.

[0009] In some embodiments, the laparoscope includes an anti -reflection coated window between the camera lens and the plurality of LEDs.

[0010] In some embodiments: the tip includes a sidewall; a groove is defined in the sidewall; and/or the window is held in the groove.

[0011] In some embodiments: at least one slot is defined in the sidewall; and a power wire and a ground wire extend from the ring-shaped substrate, through the at least one slot, and through the probe.

[0012] In some embodiments, a distal end of the sidewall is substantially flush with the distal end of the probe.

[0013] In some embodiments: the tip includes a second shelf at a proximal end of the sidewall; and a head of the image detector is on the second shelf.

[0014] In some embodiments, the laparoscope includes a plug at the proximal end of the probe.

[0015] In some embodiments, the laparoscope includes a waterproof seal at an interface between the handle and the probe and at an interface between the tip and the probe such that the laparoscope can be submerged in liquid for disinfection and/or sterilization.

[0016] In some embodiments, the tip is fixedly attached to the probe.

[0017] In some embodiments, the probe has a fixed length.

[0018] In some embodiments, the probe is rigid.

[0019] In some embodiments, the probe and the tip are free of optical fibers.

[0020] In some embodiments, only wires associated with the image detector and the plurality of LEDs extend through the length of the probe and the handle.

[0021] In some embodiments: a cable extends from the image detector and/or the plurality of LEDs through the probe and the handle; and the cable is configured to be connected to an electronic device such that images or video from the image detector can be viewed on the electronic device, and/or such that the electronic device can provide power to the image detector and/or the plurality of LEDs.

[0022] In some embodiments, the image detector is or includes a CMOS camera.

[0023] In some embodiments, the plurality of LEDs are coated with a medical grade epoxy. [0024] In some embodiments, the laparoscope includes a second window on the plurality of LEDs. The second window may include an aperture axially aligned with the lens of the image detector such that the second window is not in the field of view of the image detector. [0025] In some embodiments, the probe and/or the tip includes stainless steel.

[0026] In some embodiments, the handle includes a polymeric material.

[0027] Another aspect of the present disclosure provides laparoscopic system comprising: a laparoscope as described herein, wherein the laparoscope includes a cable including wires from the image detector and/or the plurality of LEDs extending from the handle; and an electronic device configured to receive the cable to connect to the laparoscope to display images and/or video captured by the image detector.

[0028] In some embodiments, the electronic device is configured to provide power to the laparoscope with the cable connected thereto.

[0029] In some embodiments, the electronic device includes software configured to display video captured by the image detector on the electronic device with a frame rate greater than 20 frames per second.

[0030] In some embodiments, the electronic device includes software configured to white balance images captured by the image detector.

[0031] In some embodiments, the electronic device includes software configured to transmit images and/or video captured by the image detector to a remote location to interact with the surgery, in real time, enabling surgeons to provide mentorship.

Brief Description of the Drawings

[0009] The accompanying Figures and Examples are provided by way of illustration and not by way of limitation. The foregoing aspects and other features of the disclosure are explained in the following description, taken in connection with the accompanying example figures (also “FIG.”) relating to one or more embodiments. [0010] FIG l is a side view of a laparoscope according to some embodiments of the present invention.

[0011] FIG. 2A is a partial exploded perspective view of the laparoscope of Figure 1. [0012] FIG. 2B is another partial exploded perspective view of the laparoscope of Figure 1

[0013] FIG. 3 is a perspective view of a holder or tip of the laparoscope of Figure 1. [0014] FIG. 4 is a perspective view of an LED assembly of the laparoscope of Figure 1. [0015] FIG. 5A is fragmentary side view of an image detector and LED assembly of the laparoscope of Figure 1.

[0016] FIG. 5B is an end view of the assembly of FIG. 5 A.

[0017] FIG. 6 is a plan view of a hydrophobic window that can optionally be used with the assembly of FIGS. 5 A and 5B.

[0018] FIG. 7 is a block diagram of a laparoscopic system according to some embodiments of the present invention.

[0019] FIG. 8A is a perspective view illustrating that the Ready View laparoscope can be plugged directly into a laptop to view the image and power the device.

[0020] FIG. 8B is a perspective view illustrating the Ready View laparoscope including a CMOS camera and ring of LEDs placed at the tip of the probe.

[0021] FIG. 9 is a chart comparing the resolution achieved by the Ready View and SOC laparoscopes at various working distances and indicating that the ReadyView has comparable resolution at 3 and 4 cm. Error bars indicated standard deviation, and all groups had a sample size of n = 3.

[0022] FIG. 10A is a chart comparing the image distortion achieved by the ReadyView and SOC laparoscopes at various working distances and indicating the ReadyView has less distortion at 3 and 5 cm and slightly higher distortion at 4 cm.

[0023] FIG. 10B is a chart comparing the diagonal field of view achieved by the ReadyView and SOC laparoscopes at commonly used working distances. The ReadyView has a superior diagonal field of view at all three working distances. Error bars indicate standard deviation and all groups had a sample size of n = 3.

[0024] FIG. 11 is a chart comparing the depth of field achieved with the ReadyView and SOC laparoscopes at various working distances and indicating that ReadyView has a comparable depth of field at 3 cm and a smaller depth of field at 4 and 5 cm. Error bars indicate standard deviation and all groups had a sample size of n = 3.

[0025] FIG. 12 is a chart comparing the color reproduction error achieved with both the Ready View and SOC laparoscopes. ΔΕ _ab accounts for luminance difference while ΔC _ab does not account for luminance. The ReadyView has lower errors, indicating it has superior color accuracy. Error bars indicate standard deviation and all groups had a sample size of n = 3.

[0026] FIG. 13 is a chart illustrating illumination testing or lux testing comparing the prototype laparoscope at max intensity and the standard-of-care (SOC) set at 30% of the maximum light intensity. The ReadyView has lower light intensity than the SOC. Error bars indicate standard deviation and all groups had a sample size of n = 3.

[0027] FIG. 14 is a chart illustrating thermal testing; time vs temperature graph at the ReadyView scope tip, middle of the scope, and end of the scope near the handle. The ReadyView does not exceed 48°C (indicated by the dashed line), which is the IEC 60601 approved temperature limit for direction contact with human skin (<10 minutes duration). [0028] FIG. 15 is chart depicting the effect of the white balancing function on the pixel values of an image stream. Seven pictures before and after white balancing were captured. The values (average ± standard deviation) depicted are the ΔRGB values with respect to pure white. White balancing function yields average pixel values of approximately 128, indicating it is performing correctly.

[0029] FIGS. 16A and 16B are pictures of human skin acquired with the ReadyView (FIG. 16A) and standard-of-care (SOC) laparoscope (FIG. 16B).

Detailed Description

[0030] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to preferred embodiments and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is thereby intended, such alteration and further modifications of the disclosure as illustrated herein, being contemplated as would normally occur to one skilled in the art to which the disclosure relates. [0031] Articles “a” and “an” are used herein to refer to one or to more than one (i.e. at least one) of the grammatical object of the article. By way of example, “an element” means at least one element and can include more than one element.

[0032] “About” is used to provide flexibility to a numerical range endpoint by providing that a given value may be “slightly above” or “slightly below” the endpoint without affecting the desired result.

[0033] The use herein of the terms "including," "comprising," or "having," and variations thereof, is meant to encompass the elements listed thereafter and equivalents thereof as well as additional elements. As used herein, “and/or” refers to and encompasses any and all possible combinations of one or more of the associated listed items, as well as the lack of combinations where interpreted in the alternative (“or”).

[0034] As used herein, the transitional phrase "consisting essentially of (and grammatical variants) is to be interpreted as encompassing the recited materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. Thus, the term "consisting essentially of as used herein should not be interpreted as equivalent to "comprising."

[0035] Moreover, the present disclosure also contemplates that in some embodiments, any feature or combination of features set forth herein can be excluded or omitted. To illustrate, if the specification states that a complex comprises components A, B and C, it is specifically intended that any of A, B or C, or a combination thereof, can be omitted and disclaimed singularly or in any combination.

[0036] Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. For example, if a concentration range is stated as 1% to 50%, it is intended that values such as 2% to 40%, 10% to 30%, or 1% to 3%, etc., are expressly enumerated in this specification. These are only examples of what is specifically intended, and all possible combinations of numerical values between and including the lowest value and the highest value enumerated are to be considered to be expressly stated in this disclosure. [0037] As used herein, the term "subject" and "patient" are used interchangeably herein and refer to both human and nonhuman animals. In some embodiments, the subject comprises a human who is undergoing a laparoscopic procedure with a device as prescribed herein.

[0038] It is noted that any one or more aspects or features described with respect to one embodiment may be incorporated in a different embodiment although not specifically described relative thereto. That is, all embodiments and/or features of any embodiment can be combined in any way and/or combination. Applicant reserves the right to change any originally filed claim or file any new claim accordingly, including the right to be able to amend any originally filed claim to depend from and/or incorporate any feature of any other claim although not originally claimed in that manner. These and other objects and/or aspects of the present invention are explained in detail in the specification set forth below. [0039] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. [0040] The present disclosure provides a laparoscopic technology that is low-cost, durable, and does not require a constant supply of carbon dioxide or electricity. Rather than having an expensive light source and camera coupled to fragile fiber optic cables, the presently disclosed device is constructed with low-cost light emitting diodes (LEDs) and a camera disposed at the distal end of the device. The light source and cameras are housed in a metal probe. The device optionally comprises an ergonomic and lightweight handle.

[0041] In some embodiments, the camera can be a consumer-grade color complementary metal-oxide-semiconductor (CMOS) detector. The camera is illuminated by a ring of LEDs specifically designed for the disclosed laparoscope. The device optionally includes a hydrophobic window to prevent fogging of the laparoscope.

[0042] The device is electronically connected through to a laptop computer to provide power and to view a live video feed, obviating the need for expensive monitors and cables and preventing loss of function during power outages. The electronic connection can be wired, wireless, or a combination of the two (e.g., USB, Bluetooth, etc.).

[0043] In some embodiments, the laparoscope is waterproof. It can be sterilized by submersion, which is particularly advantageous in LMICs, where operating rooms may not have autoclave sterilization units. [0044] In some embodiments, the laparoscope is designed to plug into a laptop computer, an iPad, or other handheld monitor, so that the surgeon can use these devices to display the images during surgery. Additionally, the software to control the device allows a surgeon at a remote location to interact with the surgery, in real time, enabling surgeons to provide mentorship.

[0045] Referring now to FIGS. 1 and 2, a laparoscope 10 includes an elongated probe 12 having opposite proximal and distal ends 14, 16. The probe defines a longitudinal axis Al. A handle 18 is at the proximal end 14 of the probe 12. A tip or camera and LED holder 20 is at the distal end 16 of the probe. An LED assembly 22 and an image detector or camera 24 are each held by the holder 20. In some embodiments, a (first) transparent window 26 such as an anti-reflection coated window or hydrophobic window may be held by the holder 20.

[0046] The probe 12 may have a (constant) diameter D1 of 5 mm or less to allow the probe 12 to be received in a standard trocar port.

[0047] The probe 12 has a fixed length L 1. In some embodiments, the length L 1 is between 10 inches and 18 inches. In some embodiments, the probe 12 is a hollow tube. In some embodiments, the probe 12 is rigid (e.g., not bendable without substantial force). The probe 12 may be formed of any suitable material; in embodiments, the probe 12 is metal; in some embodiments, the probe 12 is formed of stainless steel.

[0048] In some embodiments, the handle 18 includes first and second handle pieces 18 A, 18B that are fitted together to form the handle 18. The pieces 18A, 18B may be connected by epoxy or by ultrasonic welding to provide a watertight seal. In some other embodiments, the handle 18 is a one-piece handle. The handle 18 may be formed of any suitable material; in embodiments, the handle 18 is polymeric; in some embodiments, the handle 18 is formed of acrylonitrile butadiene styrene (ABS).

[0049] Referring to FIG. 2 A, a plug 28 may be provided at the proximal end 14 of the probe 12. The plug 28 may be at the interface of the probe 12 and the handle 18. The plug 28 may help to provide a waterproof laparoscope along with other features described herein.

[0050] The camera and LED holder 20 (also referred to herein as the tip) is shown in more detail in FIG. 3. The holder 20 includes a (first) shelf 30. The shelf 30 includes opposing first and second sides or surfaces 32, 34. Referring to FIGS. 5 A and 5B, the LED assembly 22 may be on the first surface 32 of the shelf 30. The camera 24 includes a lens 36 that is adjacent the second surface 34 of the shelf 30.

[0051] Referring to FIGS. 3, 5A, and 5B, an aperture 38 may be defined in the shelf 30. The camera lens 36 may be adjacent and/or axially aligned with the aperture 38,

[0052] Referring to FIGS. 4, 5A, and 5B, the LED assembly 22 may include a substrate 40 and a plurality of LEDs 42 on the substrate 40. The substrate 40 may be a printed circuit board (PCB). In some embodiments, the substrate 40 is ring-shaped and surrounds the aperture 38 of the shelf 30; the substrate may include an aperture that is axially aligned with the aperture 38 of the shelf 30. In some embodiments, the underside of the substrate 40 (opposite the LEDs), the aperture, and/or side surfaces of the LEDs 42 are coated with black epoxy to black out lightleakage from the side of the LEDs into the camera 24. [0053] Referring again to FIG. 3, the holder 20 may include a sidewall 42. A groove 44 may be defined in the sidewall 42. As can be seen in FIG. 5 A, in some embodiments, the window 26 is received in the groove 44,

[0054] The sidewall 42 may include a proximal end portion 42P on one side of the shelf 30 and a distal end portion 42D on the other side of the shelf 30, The proximal end portion 42P of the sidewall may include at least one slot 46 defined therein. The LED assembly 22 may include a power wire 48 and a ground wire 50 (FIG. 4). The power wire 48 and the ground wire 50 may extend from the substrate 40, through the at least one slot 46, and through the probe 12 and handle 18, In some embodiments, and as shown in FIG. 3, the at least one slot 46 includes first and second slots 46A, 46B, with the povcer wire 48 extending through the first slot 46A and the ground wire extending through the second slot 46B, [0055] The holder 20 may be received in the probe 12. In some embodiments, a distal end 52 of the sidewall 42 may be flush or axially coextensive with the distal end 16 of the probe 12

[0056] A second shelf 54 may be at a proximal end 56 of the sidewall 42. Referring to FIGS. 3 and 5A, the camera 24 may include a head 58 and a body 60 extending from the head 58 toward the proximal end 16 of the probe 12. The head 58 may be on the second shelf 54. A slot 62 may be defined in the second shelf 54 and the body 60 may extend through the slot 62. [0057] The proximal end portion 42P of the sidewall may include an opening 64 for receiving the camera 24 therethrough. The opening 64 nay also facilitate inserting the window 26 into the groove 44.

[0058] There may be a seal at the interface of the probe 12 and the holder 20, at the interface of the probe 12 and the handle 18, and/or between the pieces of the handle 18 (where multiple pieces are used). The seal may be or include medical grade epoxy. The seal may allow the laparoscope to be waterproof such that the laparoscope can be submerged in liquid for sterilization.

[0059] In some embodiments, the holder 20 is fixedly attached to the probe 12 (e.g., using medial grade epoxy).

[0060] The holder 20 may be formed of any suitable material; in embodiments, the holder 20 is metal; in some embodiments, the holder 20 is formed of stainless steel.

[0061] The LEDs 42 may be coated with medical grade epoxy. In some other embodiments, and referring to FIGS. 5B and 6, a second transparent window such as a second anti -reflection window or hydrophobic window 66 may be positioned over the LEDs 42. The second window 66 may be ring-shaped with an aperture 68 axially aligned with the camera lens 36 such that the second window 66 is not in the field of view of the camera. The second window 66 may include apertures 67 or slots 69 to allow the wires 58, 60 to extend therethrough.

[0062] In some embodiments, the laparoscope including the probe 12 and the holder 20 are tree of optical fibers for illumination. Optical fibers can be fragile, and their absence allows for a more robust device. The use of LEDs instead of optical fibers helps to reduce cost, increase durability, and reduce weight of the device. In some embodiments, only wires from the camera 24 and/or the LED assembly 22 (or a cable associated therewith) extend through a major portion of the length of the probe 12 (including the proximal end 14) and the handle 18.

[0063] The probe 12 defines an inner cavity C (FIG. 1). In some embodiments, the only components in the cavity C are the camera 24 and wires and cables associated therewith, the holder 20, the window 26, the LED assembly 22 and wires and cables associated therewith, and any attachment or connection features (e.g., epoxy and solder). In some embodiments, the laparoscope 10 consists of or consists essentially of the probe 12, the handle 18, the camera 24 and wires and cables associated therewith, the holder 20, the window 26, the LED assembly 22 and wires and cables associated therewith, and any attachment or connection features (e.g., epoxy and solder).

[0064] In some embodiments, the laparoscope 10 weighs less than 1 kg. In some other embodiments, the laparoscope 10 weighs less than 0.5 kg.

[0065] Referring to FIGS. 1 and 7, the wires from the camera 24 and/or the LED assembly 22 may be included in a cable 70 that may be connected to an electronic device 72 that may be a laptop computer, a desktop computer, a tablet computer, and the like. The connection of the laparoscope to the electronic device 72 allows for images and/or video captured by the camera 24 to be displayed on a display of the electronic device. In addition, the electronic device 72 may provide power to the camera 24 and/or the LEDs 42 which may be useful in locations with intermittent power. The cable 70 may be a USB cable or cord with a USB connection, but the present invention is not limited thereto and one of ordinary skill in the art will be aware that the cable 70 and electronic device 72 may use some other form of connection (wired or wireless).

[0066] In some embodiments, the wires associated with the camera 24 (e.g., data wire(s), power wire, ground wire) may be included in the cable 70 and the wires associated with the LEDs 42 (e.g., power wire, ground wire) may be included in a second cable 74 that extends from the handle 18 of the laparoscope. The second cable 74 may be connected to an external power source 76 to provide power to the LEDs 42. The second cable 74 may be a BNC cable or cord with a BNC connection, but the present invention is not limited thereto and one of ordinary skill in the art will be aware that the cable 74 and power supply 76 may use some other form of connection.

[0067] A strain relief 78 may be included on the back of the handle 18 to help prevent damage to connections such as solder joints inside the device.

[0068] The following Example is provided by way of illustration and not by way of limitation. Example

Ready View Prototype

[0069] Laparoscopic surgery is the standard of care in high-income countries for many procedures in the chest and abdomen. It avoids large incisions by using a tiny camera and fine instruments manipulated through keyhole incisions, but it is generally unavailable in low- and middle-income countries (LMICs) due to the high cost of installment, lack of qualified maintenance personnel, unreliable electricity, and shortage of consumable items. Patients in LMICs would benefit from laparoscopic surgery, as advantages include decreased pain, improved recovery time, fewer wound infections, and shorter hospital stays. To address this need, the present inventors developed an accessible laparoscopic system, called the ReadyView laparoscope for use in LMICs. The device includes an integrated camera and LED light source that can be displayed on any monitor. The ReadyView laparoscope was evaluated with standard optical imaging targets to determine its performance against a state-of-the-art commercial laparoscope. The ReadyView laparoscope has a comparable resolving power, lens distortion, field of view, depth of field, and color reproduction accuracy to a commercially available endoscope, particularly at shorter, commonly used working distances (3-5 cm). Additionally, the ReadyView has a cooler temperature profile, decreasing the risk for tissue injury and operating room fires. The ReadyView features a waterproof design, enabling sterilization by submersion, as commonly performed in LMICs. A custom desktop software was developed to view the video on a laptop computer with a frame rate greater than 30 frames per second and to white balance the image, which is critical for clinical use. The ReadyView laparoscope is capable of providing the image quality and overall performance needed for laparoscopic surgery. This portable low-cost system is well suited to increase access to laparoscopic surgery in LMICs.

[0070] Laparoscopic surgery is the standard of care in high income countries for many procedures in the abdomen and chest, such as cancer excision, organ resection, and treatment of other surgical diseases. It avoids large incisions associated with open surgery by using a small camera and fine instruments manipulated through keyhole incisions. Advantages of laparoscopic surgery include smaller incisions, decreased pain, improved recovery time, minimized post-surgical infections, and shorter hospital stays. Patients in low- and middle- income countries (LMICs) would further benefit from laparoscopic surgery since the reduced recovery time would enable patients to return to home and work more quickly, thus mitigating impoverishing health costs. Laparoscopic surgery would reduce postoperative complications in overcrowded wards and minimize the stigma associated with certain surgical conditions.

[0071] Despite these advantages, laparoscopic surgery is rare in LMICs and patients often receive open surgery instead, representing a great health care disparity. There is an initial equipment purchase cost of $133,000-136,000 for each operating room that includes the components of the laparoscope, viewing monitors and related equipment — a cost that is prohibitive for most health systems in LMICs. Current laparoscopic technology uses fragile fiber optic cables, cameras, and lenses that require repair, necessitating annual service contracts. Moreover, the current standard of care laparoscope requires a continuous power source, which is not always attainable in countries with frequent power outages. Laparoscopes are also composed of several components, which must be sterilized and reassembled after each use. If one of these parts is lost or broken, it is often difficult to replace in LMICs.

[0072] Previous work has explored developing new imaging systems for surgical use. For example, investigators in LMICs have recently described attaching a 10 mm scope to the camera of a smartphone. This system continues to use fiber optic cables for the light source, which are fragile, and thus not ideal for LMICs. It also uses elastic bands to hold the camera in place, while covering the apparatus with plastic sheets to obtain sterility. The design is cumbersome, and not easily sterilizable. In high-income countries, others have investigated the utility of using a color complementary metal-oxide-semiconductor (CMOS) camera to include fluorescent images in laparoscopic surgery, and those interested in single incision laparoscopic surgery have devised a laparoscopic port that contains a CMOS camera and light-emitting diodes (LEDs). The latter two technologies were designed to augment laparoscopic surgery in high-income countries and therefore do not address the needs of LMICs. These designs still rely on expensive components that must be separately sterilized and reassembled after each use. If one component is lost, it is difficult to obtain replacement parts in LMICs, and the device becomes unusable. The port designed for single-incision laparoscopy contains a camera that rotates out of the port after insertion, and it is not difficult to envision that this design will break easily with multiples uses. Therefore, there is a need to design a laparoscope that is affordable and attends to the technological barriers encountered in LMICs.

[0073] To address this unmet clinical need, the present inventors designed an accessible device called the ReadyView laparoscope that addresses the technological barriers described above. The design of our device replaces expensive and fragile fiber optics with small LEDs and a CMOS detector that sits at the tip of the scope. This design enables a significant decrease in cost and complexity and does not require disassembly prior to sterilization by immersion. Moreover, images can be displayed on any laptop computer or device screen via a universal serial bus (USB) cord, obviating the need for expensive monitors and preventing loss of function during power outages.

ReadyView System Design

[0074] The ReadyView laparoscope (FIG. 8) contains a 4.5 mm diameter CMOS detector (Aliexpress, 4.5 mm 720P USB Endoscope Module, 8 bit) for video and image capture surrounded by a custom ring of LEDs (Mouser, High Power LEDs, Cool White, 6500 K, 500 mA, 2.8 V) to illuminate the abdomen with white light. The camera was selected because of its small diameter, which is less than 5 mm, allowing it to fit within a standard trocar port. The working distance of the camera is 3-7 cm, which are common distances used by surgeons during laparoscopy. The CMOS camera is joined to a USB cord that can be connected to a laptop computer for imaging. A custom printed circuit board was designed to mount the LEDs, with an outer diameter less than 5 mm and the inner diameter to accommodate the aperture of the CMOS detector. The LED ring is connected to a Bayonet Neill-Concelman (BNC) cable and can be plugged into a small battery-powered source to provide power to the LEDs.

[0075] Rather than using multiple components that must be pieced together after each sterilization, our device has been constructed as an integrated instrument. The camera and light source have been moved to the tip, which is protected by a hydrophobic window to prevent fogging that could obscure the image during surgery. The scope was made from stainless steel while the handle was 3D printed using Acrylonitrile Butadiene Styrene. These materials are easily sterilizable and biocompatible. The laparoscope and handle contain only the wires from the light source and camera, contributing to a light-weight design of 0.23 kg. The resulting cord from the light source and camera can be attached to a laptop computer for image viewing and powering the device. A gray strain relief is included on the back of the handle to prevent the user from damaging the solder joints inside the device. To prevent any bodily fluids from entering the device and damaging the inner electronics, waterproof seals (two rounds of clear epoxy with a 24-h cure) were created between the hydrophobic window and probe, between the probe and the handle, and along the handle. As an additional protective measure, a catheter glue plug (also waterproof) was formed in the backend of the probe to mitigate any fluid leakage through the handle.

Image Quality Characterization

[0076] To assess the image quality and performance of the device, a series of targets were imaged with Ready View camera and compared to a commercial laparoscope (Karl Storz, Tuttlingen, Germany). A custom optical set-up was used to acquire images of various imaging targets as previously described. Each target was imaged at working distances commonly used by surgeons during laparoscopic surgery. Three images were acquired at each working distance, so that an average and standard deviation of various image parameters could be calculated from the images of the targets. To maintain consistent illumination, two lightbulbs angled at 20° to 40° were placed on either side of the target and a white backdrop was placed behind the target. The entire system was then enclosed in a black box to minimize reflections and outside light interference.

[0077] First, a USAF 1951 resolution target (Thorlabs, R3L3S1P) was used to discern the minimal line width that could be resolved by the camera. The resolving power (in microns) was assessed using open-source software, ImageJ (University of Wisconsin - Madison). Specifically, a line was drawn through all of the elements within a group, and the pixel values were plotted using the ‘plot profile’ function in ImageJ. The point at which the ratio of peak (white pixels) to trough (black pixels) fell below 2 was considered the limit of resolution. This testing was completed with the Ready View laparoscope and compared to the standard of care (SOC) laparoscope.

[0078] The radial lens distortion was assessed by imaging a checkerboard geometric distortion target (Applied Image Incl, QI-SFR15-P-CG) at multiple working distances. The images were analyzed using Imatest (Imatest, Boulder CO), which determined if distortion was present. Specifically, the percentage of distortion was calculated by using standard mobile imaging architecture (SMIA) TV Distortion: where Ai and A2 are the outer side lengths of a square while B is the distance between the midpoints of the sides of the square. The distortion target was also used to calculate the diagonal of view (DFOV) of the camera in Imatest software. The DFOV was calculated to determine the projected field and compared with the SOC laparoscope.

[0079] To determine the furthest discernable distance from the camera's tip, the depth of field of the camera was assessed by imaging a depth of field gauge (Edmund Optics, 54- 440) at various working distances with a similar optical setup as described previously. The images were analyzed using ImageJ and compared to the SOC endoscope. A line was drawn through the column of lines at the righthand side of the target, which has 5 line pairs per millimeter. The pixel values were plotted using the ‘plot profile’ function in ImageJ, and the difference between the first full peak (white pixels) to trough (black pixels) was determined. The point at which the difference between the peak and trough fell below half of the initial value was considered the depth of field.

[0080] The color accuracy and tone of the camera was assessed by imaging the NIST- calibrated X-Rite Rez Checker Target (Edmund Optics, 87-422). The target was imaged using a similar optical setup. The working distance was adjusted so that the entire color target could be captured in a single image. The images of the color target were assessed using open-source image processing software, Imatest. The software calculated the difference between the known reference and measured color space values using the Euclidean distance equation accounting for luminance differences between the reference and measured data: where ΔL* is the difference in luminance between the reference and measured data, and Δa*and Δb* are the color-opponent dimensions. The perceptible color difference that does not account for luminance difference can be calculated using the following:

Characterization of Illumination

[0081] Light intensity quantification of the device was completed by mounting the device into the custom optical setup. The illumination was measured with a B&K Precision 615 Light Meter (Digikey, BK615-ND) at common working distances used by surgeons. The device was aimed towards the center of the detector on the lux meter and enclosed in a black box to remove any outside light or interference. These measurements were then compared to the SOC laparoscope, which could be varied from 0 to 100% illumination. Specifically, for each working distance measurements were taken at 30% intensity (which is the minimum light intensity currently used during surgery) up to where the lux meter was saturated. Three repeated measurements were taken at each working distance from which the average and standard deviation were calculated.

Thermal Testing

[0082] To ensure patient safety, thermal testing of the device was conducted. The device was placed in the optical setup described in previous sections, turned on, and measurements were taken at 10-min intervals over a 90-min period using a non-contact IR thermometer (Fluke, 62 Max +). Each measurement was taken at the probe tip, near the inner electronics of the device, at the mid-way point along the probe and at the probe-handle interface. Waterproofing of Device

[0083] Autoclave machines are commonly used in HICs and use pressurized steam at 121 °C for 15-20 min to achieve sterilization of medical instruments. In many LMIC hospitals, autoclave machines are unavailable due to issues with power supply, water pressure, or steam capacity. Thus it is common practice to sterilize medical instruments by immersion using agents such as bleach, chlorine, or Cidex OPA solutions. In the Ready View device, both the stainless steel probe and APA handle are Cidex OPA compatible materials. Waterproof testing was performed to ensure the isolation of the inner electronics of the device at two junctions: at the window-scope tip junction and the scope tip-handle junction. These two junctions were selected specifically because all electronics in the Ready View laparoscope are contained within the tip of the probe. The remainder of the laparoscope only carries insulated cord, which is waterproof. Thus, if the probe tip is waterproofed from both the front and back of the probe, then the entire laparoscope can be submerged. To assess whether each junction was waterproofed, a strip of Hydrion water finding test paper (Micro Essential Laboratory Inc, Brooklyn NY) was inserted into the probe and the junction was fully submerged in water for 1 h. The paper was removed from the probe and inspected for color change, which would indicate the junction was not effectively waterproofed. For completeness, the entire Ready View laparoscope was submerged in water for 1 h, with the exception of the USB connector at the end of the cord, and then tested for functionality.

Custom Software Platform

[0084] A custom software platform was developed for use with the ReadyView laparoscope using JavaScript, CSS, and HTML. White balancing of the camera ensures proper image quality before beginning a laparoscopic surgery. It is commonly performed by focusing the laparoscope on a white gauze. White balancing corrects the video color tone to minimize erroneous color perceptions in the middle of a procedure. To test the white balance capabilities of the software code, a series of testing protocols were designed. First, the software captures an image of a white target for reference. The average red, green and blue (RGB) values are extracted for the white target. Next, the software runs the white balance script to optimize the image. Another photo of the white target was taken post- optimization and average RGB values were extracted. These images were analyzed quantitatively, by calculating the difference between the average true white RGB values and the average optimized RGB values:

Video Delay Time of the Camera

[0085] To ensure that the white balance feature did not affect the lag time of the video, a series of qualitative tests were designed. A function TimeElapsed was used to assess the time it takes to refresh the screen pre- and post-white balance. The reciprocal of the TimeElapsed output was used to estimate the frames per second and determine whether the white balance feature adds a delay time.

RESULTS Image Quality

[0086] A resolution target was imaged with both the Ready View laparoscope and the SOC laparoscope. Lower values indicate a superior resolution since smaller objects are more easily discemable. Thus, these results portray that the Ready View has a comparable resolution to the SOC laparoscope at a working distance of 3 and 4 cm, while at 5, 6, and 7 cm, the SOC resolution is slightly better (FIG. 9). Considering that laparoscopes are used at working distances around 5 cm during operations, this is an acceptable range of resolutions.

[0087] During surgery, it is important to have an accurate representation of the size and shape of structures and limit the projected image’s distortion percentage. To assess distortion, a distortion target was imaged with both the Ready View and SOC laparoscopes. At 3 cm and 5 cm, the ReadyView laparoscope has a lower percentage of distortion in comparison to the SOC laparoscope. At 4 cm, the ReadyView has a larger percentage of distortion in comparison to the SOC laparoscope, as seen in FIG. 10A. This analysis shows that the ReadyView laparoscope does not have significant optical aberrations, indicating that this camera can accurately image targets with minimal distortion.

[0088] The diagonal field of view (DFOV) is directly proportional to the area that can be viewed, thus a larger field of view during surgery would allow a surgeon to observe a larger imaging field. It is beneficial during surgery to have an increased field of view to obtain a complete visual of the body. The experimental results show that the ReadyView had a larger DFOV at all three working distances in comparison to the SOC (FIG. 10B). This indicates that the ReadyView can capture a larger area at each working distance in comparison to the SOC.

[0089] While the DFOV provides information about the area that can be viewed in a single image/frame, the camera’s depth of field capabilities determines the distance between the nearest and furthest objects in an image that is in focus with the camera. During surgery, it may be beneficial to achieve a large depth of field in order to obtain all information without needing to refocus or relocate the device. The depth of field assessment can be seen in FIG. 11, in which the Ready View had a superior depth of field at a working distance of 3 cm. At 4 cm and 5 cm, the ReadyView had an inferior depth of field in comparison to the standard of care. This can be attributed to the fact that the SOC laparoscope can be re- focused at various distances whereas the ReadyView has an optimal focal length around 3 cm.

[0090] The color accuracy of the projected image is important during surgery because certain procedures require accurate classification of tissue which is dependent on the color. The mean color error comparing the ReadyView and the SOC can be seen in FIG. 12. For both color accuracy tests, the ReadyView had a superior color accuracy in comparison to the SOC laparoscope, which would benefit surgeons during laparoscopy.

Illumination Testing

[0091] During laparoscopic surgery, the area under investigation must be illuminated in order to produce a clear image. To assess the illumination quality, a series of experimental tests were conducted at various working distances and compared to the SOC laparoscope at 30% intensity (minimum light intensity currently used during surgery). As seen in FIG. 13, the ReadyView had an inferior light intensity value (lux) in comparison to the SOC because it uses an LED light source. In vivo testing will be used to confirm that the light intensity of the ReadyView is sufficient for surgery.

Thermal Testing

[0092] To determine whether the ReadyView operates at a safe temperature for insertion in the human body, thermal testing was completed. First-degree skin bums occur at 48 °C for direct contact with human skin lasting less than 10 min in duration, and this is the IEC 60,601 approved temperature limit. FIG. 14 illustrates that the ReadyView performed at temperatures of 25-43 °C. This is well below 48 °C, indicating a safe operating temperature for surgical use.

Waterproof Testing

[0093] To protect the inner electronics while the laparoscope is in use and during sterilization by immersion, a waterproof seal at the hydrophobic window juncture of the handle is required. As described in the methods section, the window-probe seal and probe- handle seal were waterproof tested. These interfaces were submerged first for 30 s and then for 1 h. This was repeated for 2 different prototypes. In all testing scenarios, the water detection paper remained dry. The ReadyView laparoscope was also submerged in its entirety for 1 h with the exception of the USB connector, then tested and demonstrated to be fully functional.

Software Testing

[0094] The effects of the white-balancing algorithm are shown in FIG. 15. The white balance algorithm was intended to normalize the color channels to 128 in the video stream. Normalizing the color channel averages removes undesirable tints in the video stream, allowing for the best image during surgery. Prior to applying the white balance, the average pixel values for the red, green, and blue channels each was approximately 115 with large standard deviations. After applying the algorithm to the image, the pixel values for all three channels changed to approximately 128 with much smaller standard deviations. The algorithm centered the color channels to 128 and tightened the distribution of pixels, therefore making a more consistent image and removing irregular shades. Likewise, the frame rate of the video was observed with the white balance algorithm applied and not applied. When the white balance is off, the stream provides approximately 57.9 frames per second; when the white balance is on, the stream provides approximately 30.3 frames per second. While the human eye can process individual images at 10-12 frames per second, the National Television System Committee recommends a minimum of 30 frames per second for smooth-appearing video. Both methods were observed to meet this minimum. Biological Tissue Imaging

[0095] Representative images of human skin acquired with the ReadyView and SOC laparoscopes are shown in FIG. 16. Both images were taken at a 5 cm working distance. As seen, similar features such as fingerprints and the grains of the blue towel can be detected in each image.

DISCUSSION

[0096] The ReadyView laparoscope was uniquely designed to address the specific needs of LMICs. This simple design uses affordable and robust electrical components that are securely enclosed in a lightweight case. The waterproofed enclosure allows for sterilization by immersion, a common technique used in LMICs. Due to elimination of fragile fiber optics and replacement with inexpensive electronics, the need for annual service contracts and expensive replacements are eliminated. Furthermore, the live video image can be displayed via USB to any viewing monitor such as a laptop, smartphone, or television. [0097] It has been shown through various analyses that the ReadyView camera has comparable functionality to that of a SOC laparoscope and can be safely used during surgery. The ReadyView camera resolved the smallest feature size of 111 μm at a working distance of 3 cm, exceeding the SOC's resolution capability of 125 μm at this working distance. While the ReadyView demonstrated a small amount of lens distortion, this value was a fraction of the SOC's image distortion at 3 and 5 cm. The ReadyView achieved < 5% of distortion at both distances indicating that while there are minor distortions, it will not significantly hinder a surgeon's capability to operate. Further, the ReadyView can capture a larger area at all relevant working distances in comparison to the SOC, with a significant increase in diagonal field of view at the 3 and 5 cm working distances. This allows surgeons to image a larger area and gain more information about the area of interest in the patient. The ReadyView possesses a minor color error of 6%, which is a significant improvement in comparison to the SOC's color error of 16%. Imaging accurate colors allows surgeons to differentiate between diseased and healthy tissue and is a necessity during surgery. The aforementioned camera characterization indicates that the ReadyView has comparable imaging capabilities to current commercial laparoscopes and can produce an accurate image during surgery.

[0098] The ReadyView offers many safety advantages in comparison to current commercial laparoscopic systems. The ReadyView scope tip remained well below 48 °C, a temperature significantly lower than the SOC's operating temperature of 100 °C. The LEDs allow for cooler operating temperatures and can decrease the number of operating room fires. These cooler temperatures will also minimize inadvertent intestinal bums, which can cause delayed bowel perforation and subsequent abdominal sepsis. Additionally, the current weight of the ReadyView (0.23 kg) is significantly lighter than the SOC laparoscope (6.5 kg). The lightweight handle and elimination of heavy fiber optics contributes to the ergonomic design and will alleviate surgeon fatigue.

[0099] Moreover, in the event of a power outage, the ReadyView will have continued functionality due to the device' s outlet-free design. Because the ReadyView can be plugged into any electronic display system via USB, the laparoscope cord length can be adjusted by simply adding a retractable USB extender. This distinct feature would minimize operating room injuries due to tripping over exposed medical equipment cords.

[00100] The Ready View lacks a comparable depth of field and image resolution to the SOC at larger working distances since the integrated camera has an optimal focal length of 3 cm. However, the current Ready View prototype can be moved closer to the target to achieve a finer resolution and produce an image of similar quality to the commercial laparoscope. Additionally, other cameras that have optimal focal lengths of 5-10 cm are currently being identified and tested to address this limitation in future prototypes. Due to the compact and affordable design, the ReadyView laparoscope does not have a comparable light intensity to the output of the SOC. Although the lux values are inferior to the SOC, the results indicate that the ReadyView achieves approximately a third to half that of the SOC. In vivo testing will be conducted to assess if the ReadyView light intensity is sufficient to perform surgery. If needed, a voltage booster will be incorporated into the ReadyView design which will increase the voltage delivered to the LEDs to increase the illumination. The design of the ReadyView will continue to be optimized for manufacturing through work with an industry partner, which will facilitate the construction of more units. Parts that are currently 3D printed will be transitioned to injection molding, and other parts will be available for bulk purchase. These modifications will likely decrease the cost of goods per unit, but labor costs may be higher for units made by an industry partner.

[00101] Laparoscopic procedures will be performed in a porcine model by surgeons with proficiency in laparoscopic surgery to compare the safety and performance of the device to the SOC laparoscope. Additionally, surgeons will provide feedback on the usability of the design, and the lifetime and durability of the protype will be evaluated. After conducting laparoscopic procedures in a porcine model, the ReadyView design will be improved in response to surgeon feedback. These studies will also provide preclinical safety and efficacy data in preparation for regulatory submission and clinical trials. Specifically, the ReadyView could be cleared through the Food and Drug Administration's (FDA) 510(k) pathway by demonstrating substantial equivalence (in terms of image quality and safety) to a predicate device, such as the SOC laparoscope tested here. FDA clearance is accepted in many LMICs. [00102] In conclusion, laboratory testing of the ReadyView prototype indicates comparable performance (resolution, field of view, distortion, depth of field, color accuracy) to the SOC laparoscope while also addressing some of the barriers to implementation in LMICs. Specifically, the ReadyView is built with low-cost consumer grade electronics, does not rely on consistent electricity, does not require regular maintenance or qualified maintenance personnel, can be easily sterilized with chemical immersion, and can be used with a standard laptop computer. This portable system is well suited to increase access to laparoscopic surgery in LMICs.

[00103] The control systems described herein can be implemented in hardware, software, firmware, or combinations of hardware, software and/or firmware. In some examples, the control systems described in this specification may be implemented using a non-transitory computer readable medium storing computer executable instructions that when executed by one or more processors of a computer cause the computer to perform operations. Computer readable media suitable for implementing the control systems described in this specification include non-transitory computer-readable media, such as disk memory devices, chip memory devices, programmable logic devices, random access memory (RAM), read only memory (ROM), optical read/write memory, cache memory, magnetic read/write memory, flash memory, and application-specific integrated circuits. In addition, a computer readable medium that implements a control system described in this specification may be located on a single device or computing platform or may be distributed across multiple devices or computing platforms.

[00104] One skilled in the art will readily appreciate that the present disclosure is well adapted to carry out the objects and obtain the ends and advantages mentioned, as well as those inherent therein. The present disclosure described herein are presently representative of preferred embodiments, are exemplary, and are not intended as limitations on the scope of the present disclosure. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the present disclosure as defined by the scope of the claims.

[00105] No admission is made that any reference, including any non-patent or patent document cited in this specification, constitutes prior art. In particular, it will be understood that, unless otherwise stated, reference to any document herein does not constitute an admission that any of these documents forms part of the common general knowledge in the art in the United States or in any other country. Any discussion of the references states what their authors assert, and the applicant reserves the right to challenge the accuracy and pertinence of any of the documents cited herein. All references cited herein are fully incorporated by reference, unless explicitly indicated otherwise. The present disclosure shall control in the event there are any disparities between any definitions and/or description found in the cited references.

[00106] The foregoing is illustrative of the present invention and is not to be construed as limiting thereof. Although a few exemplary embodiments of this invention have been described, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the claims. The invention is defined by the following claims, with equivalents of the claims to be included therein.