WO2021212035A1 - Laparoscope à bas prix - Google Patents

Laparoscope à bas prix Download PDF

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Publication number
WO2021212035A1
WO2021212035A1 PCT/US2021/027775 US2021027775W WO2021212035A1 WO 2021212035 A1 WO2021212035 A1 WO 2021212035A1 US 2021027775 W US2021027775 W US 2021027775W WO 2021212035 A1 WO2021212035 A1 WO 2021212035A1
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WIPO (PCT)
Prior art keywords
laparoscope
probe
image detector
leds
tip
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PCT/US2021/027775
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English (en)
Inventor
Tamara FITZGERALD
Jenna MUELLER
Original Assignee
Duke University
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Publication of WO2021212035A1 publication Critical patent/WO2021212035A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/313—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes
    • A61B1/3132—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes for laparoscopy

Definitions

  • 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.
  • 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.
  • the visual detector comprises a CMOS detector.
  • the light source comprises a ring of LEDs disposed at a distal end of the device.
  • 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.
  • 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.
  • the laparoscope includes an anti -reflection coated window between the camera lens and the plurality of LEDs.
  • the tip includes a sidewall; a groove is defined in the sidewall; and/or the window is held in the groove.
  • 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.
  • a distal end of the sidewall is substantially flush with the distal end of the probe.
  • 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.
  • the laparoscope includes a plug at the proximal end of the probe.
  • 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.
  • the tip is fixedly attached to the probe.
  • the probe has a fixed length.
  • the probe is rigid.
  • the probe and the tip are free of optical fibers.
  • only wires associated with the image detector and the plurality of LEDs extend through the length of the probe and the handle.
  • 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.
  • the image detector is or includes a CMOS camera.
  • the plurality of LEDs are coated with a medical grade epoxy.
  • 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.
  • the probe and/or the tip includes stainless steel.
  • the handle includes a polymeric material.
  • 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.
  • the electronic device is configured to provide power to the laparoscope with the cable connected thereto.
  • 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.
  • the electronic device includes software configured to white balance images captured by the image detector.
  • 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.
  • FIG l is a side view of a laparoscope according to some embodiments of the present invention.
  • FIG. 2A is a partial exploded perspective view of the laparoscope of Figure 1.
  • FIG. 2B is another partial exploded perspective view of the laparoscope of Figure 1
  • FIG. 3 is a perspective view of a holder or tip of the laparoscope of Figure 1.
  • FIG. 4 is a perspective view of an LED assembly of the laparoscope of Figure 1.
  • FIG. 5A is fragmentary side view of an image detector and LED assembly of the laparoscope of Figure 1.
  • FIG. 5B is an end view of the assembly of FIG. 5 A.
  • FIG. 6 is a plan view of a hydrophobic window that can optionally be used with the assembly of FIGS. 5 A and 5B.
  • FIG. 7 is a block diagram of a laparoscopic system according to some embodiments of the present invention.
  • 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.
  • 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.
  • 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.
  • FIG. 10B is a chart comparing the diagonal field of view achieved by the ReadyView and SOC laparoscopes at commonly used working distances.
  • FIG. 12 is a chart comparing the color reproduction error achieved with both the Ready View and SOC laparoscopes.
  • ⁇ ab accounts for luminance difference while ⁇ C ab does not account for luminance.
  • 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.
  • 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).
  • 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 ⁇ RGB values with respect to pure white. White balancing function yields average pixel values of approximately 128, indicating it is performing correctly.
  • FIGS. 16A and 16B are pictures of human skin acquired with the ReadyView (FIG. 16A) and standard-of-care (SOC) laparoscope (FIG. 16B).
  • “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.
  • any feature or combination of features set forth herein can be excluded or omitted.
  • any feature or combination of features set forth herein can be excluded or omitted.
  • the term "subject” and “patient” are used interchangeably herein and refer to both human and nonhuman animals.
  • the subject comprises a human who is undergoing a laparoscopic procedure with a device as prescribed herein.
  • the present disclosure provides a laparoscopic technology that is low-cost, durable, and does not require a constant supply of carbon dioxide or electricity.
  • 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.
  • the camera can be a consumer-grade color complementary metal-oxide-semiconductor (CMOS) detector.
  • CMOS complementary metal-oxide-semiconductor
  • 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.
  • 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.).
  • 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.
  • 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.
  • 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.
  • a (first) transparent window 26 such as an anti-reflection coated window or hydrophobic window may be held by the holder 20.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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,
  • 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).
  • 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.
  • 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.
  • 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,
  • 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.
  • 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.
  • a distal end 52 of the sidewall 42 may be flush or axially coextensive with the distal end 16 of the probe 12
  • a second shelf 54 may be at a proximal end 56 of the sidewall 42.
  • 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.
  • 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.
  • 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.
  • the holder 20 is fixedly attached to the probe 12 (e.g., using medial grade epoxy).
  • 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.
  • the LEDs 42 may be coated with medical grade epoxy.
  • 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.
  • 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.
  • 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.
  • the probe 12 defines an inner cavity C (FIG. 1).
  • 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).
  • 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).
  • the laparoscope 10 weighs less than 1 kg. In some other embodiments, the laparoscope 10 weighs less than 0.5 kg.
  • 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.
  • 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).
  • the wires associated with the camera 24 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.
  • 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.
  • Example 1 The following Example is provided by way of illustration and not by way of limitation. Example
  • 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.
  • 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.
  • LMICs middle- income countries
  • CMOS complementary metal-oxide-semiconductor
  • LEDs light-emitting diodes
  • 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.
  • 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.
  • 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.
  • USB universal serial bus
  • 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.
  • BNC Bayonet Neill-Concelman
  • our device 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.
  • waterproof seals two rounds of clear epoxy with a 24-h cure
  • a catheter glue plug also waterproof was formed in the backend of the probe to mitigate any fluid leakage through the handle.
  • 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.
  • 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.
  • SMIA standard mobile imaging architecture
  • 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.
  • 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.
  • 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 ⁇ L* is the difference in luminance between the reference and measured data, and ⁇ a*and ⁇ b* are the color-opponent dimensions.
  • the perceptible color difference that does not account for luminance difference can be calculated using the following:
  • 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.
  • Hydrion water finding test paper Mocro Essential Laboratory Inc, Brooklyn NY
  • 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.
  • 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:
  • 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.
  • 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).
  • laparoscopes are used at working distances around 5 cm during operations, this is an acceptable range of resolutions.
  • the diagonal field of view 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.
  • the camera 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.
  • 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.
  • the ReadyView had a superior color accuracy in comparison to the SOC laparoscope, which would benefit surgeons during laparoscopy.
  • a waterproof seal at the hydrophobic window juncture of the handle is required.
  • 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.
  • 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.
  • the average pixel values for the red, green, and blue channels each was approximately 115 with large standard deviations.
  • 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.
  • the frame rate of the video was observed with the white balance algorithm applied and not applied.
  • the stream 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.
  • FIG. 16 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.
  • 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 ⁇ m at a working distance of 3 cm, exceeding the SOC's resolution capability of 125 ⁇ m 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • other cameras that have optimal focal lengths of 5-10 cm are currently being identified and tested to address this limitation in future prototypes.
  • 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.
  • 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.
  • 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.
  • the ReadyView design 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 Food and Drug Administration's
  • 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.
  • 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.
  • control systems described herein can be implemented in hardware, software, firmware, or combinations of hardware, software and/or firmware.
  • 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.
  • 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.

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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Pathology (AREA)
  • Radiology & Medical Imaging (AREA)
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Abstract

L'invention concerne un laparoscope qui comprend : une sonde allongée comportant une extrémité proximale et une extrémité distale ; une poignée au niveau de l'extrémité proximale de la sonde ; une pointe au niveau de l'extrémité distale de la sonde, la pointe contenant un plateau présentant une première surface faisant face à l'extrémité distale de la sonde et une seconde surface opposée faisant face à l'extrémité proximale de la sonde ; une pluralité de DEL sur la première surface du plateau ; et un détecteur d'image comprenant une lentille adjacente à la seconde surface du plateau.
PCT/US2021/027775 2020-04-17 2021-04-16 Laparoscope à bas prix WO2021212035A1 (fr)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5349942A (en) * 1992-06-06 1994-09-27 Richard Wolf Gmbh Flexible endoscope
US5593402A (en) * 1994-11-14 1997-01-14 Biosearch Medical Products Inc. Laparoscopic device having a detachable distal tip
US20020193664A1 (en) * 1999-12-29 2002-12-19 Ross Ian Michael Light source for borescopes and endoscopes
US20130144122A1 (en) * 1997-10-06 2013-06-06 Micro-Imaging Solutions Llc Reduced area imaging device incorporated within endoscopic devices
US20190206281A1 (en) * 2018-01-04 2019-07-04 Applied Medical Resources Corporation Surgical simulation camera scope

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5349942A (en) * 1992-06-06 1994-09-27 Richard Wolf Gmbh Flexible endoscope
US5593402A (en) * 1994-11-14 1997-01-14 Biosearch Medical Products Inc. Laparoscopic device having a detachable distal tip
US20130144122A1 (en) * 1997-10-06 2013-06-06 Micro-Imaging Solutions Llc Reduced area imaging device incorporated within endoscopic devices
US20020193664A1 (en) * 1999-12-29 2002-12-19 Ross Ian Michael Light source for borescopes and endoscopes
US20190206281A1 (en) * 2018-01-04 2019-07-04 Applied Medical Resources Corporation Surgical simulation camera scope

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