WO2020163753A1 - Lighted cannula system - Google Patents

Lighted cannula system Download PDF

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Publication number
WO2020163753A1
WO2020163753A1 PCT/US2020/017276 US2020017276W WO2020163753A1 WO 2020163753 A1 WO2020163753 A1 WO 2020163753A1 US 2020017276 W US2020017276 W US 2020017276W WO 2020163753 A1 WO2020163753 A1 WO 2020163753A1
Authority
WO
WIPO (PCT)
Prior art keywords
cannula
cannula tube
proximal end
tube
lights
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2020/017276
Other languages
English (en)
French (fr)
Inventor
Robert J. Flower
Mark J. ZECHMEISTER
Lindsay Lam
Todd D. MCINTYRE
Peter G. Davis
Ravut CHHIT
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Rebound Therapeutics Corp
Original Assignee
Rebound Therapeutics Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Rebound Therapeutics Corp filed Critical Rebound Therapeutics Corp
Priority to KR1020217028119A priority Critical patent/KR20210114068A/ko
Priority to JP2021544202A priority patent/JP7633934B2/ja
Priority to CN202080012514.2A priority patent/CN113423349A/zh
Priority to EP20752885.2A priority patent/EP3920815B1/en
Priority to CA3127963A priority patent/CA3127963A1/en
Priority to AU2020219357A priority patent/AU2020219357B2/en
Publication of WO2020163753A1 publication Critical patent/WO2020163753A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61B1/06—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 with illuminating arrangements
    • A61B1/0661—Endoscope light sources
    • A61B1/0669—Endoscope light sources at proximal end of an endoscope
    • 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
    • A61B1/04—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 combined with photographic or television appliances
    • A61B1/042—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 combined with photographic or television appliances characterised by a proximal camera, e.g. a CCD camera
    • 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
    • A61B1/06—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 with illuminating arrangements
    • A61B1/0607—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 with illuminating arrangements for annular illumination
    • 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
    • A61B1/06—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 with illuminating arrangements
    • A61B1/0661—Endoscope light sources
    • A61B1/0684—Endoscope light sources using light emitting diodes [LED]
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/02—Inorganic materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00902—Material properties transparent or translucent
    • A61B2017/00907—Material properties transparent or translucent for light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A61B2090/309—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure using white LEDs

Definitions

  • U.S. Patent 10,172,525 discloses a cannula and proximally mounted camera system for improved visualization of the brain during minimally invasive surgery.
  • the system includes a cannula with a camera mounted on the proximal end of the cannula with a view into the cannula lumen and the tissue within and below the lumen, along with a prism, reflector or other suitable optical element oriented between the camera and the lumen of the cannula to afford the camera a view into the cannula while minimizing obstruction of the lumen.
  • Lighting disclosed in this patent included lights in the cannula to illuminate the distal end of the cannula or tissue near the distal end of the cannula, or light sources provided outside the assembly, or from lights mounted on the proximal end of the cannula.
  • a cannula suitable for use in minimally invasive surgery is improved with a highly polished and very smooth luminal wall and/or LED's or other light sources focused at particular angles relative to the axis of the cannula.
  • Figures 1 through 4 illustrate a lighted cannula system.
  • Figures 5 through 7 illustrate a lighted cannula system with an cannula tube of non-uniform diameter.
  • Figure 8 illustrates a lighted cannula system with a cannula tube of non-uniform diameter, with a proximal light source consisting of two LED's.
  • Figure 1 illustrates a cannula system 1 for
  • the cannula system comprises a cannula tube 2 and a lighting assembly 3 disposed proximate the proximal end 2p of the cannula tube.
  • the lighting assembly 3 comprises a housing 4 with a number of lights 5 (LED's, incandescent bulbs, etc.).
  • the lighting assembly may be mounted on a ring, or partial ring 6 as illustrated, and may be permanently fixed or releasably attachable to the proximal end 2p of the cannula tube, through releasable attachment means such as a C-ring expandable to engage a groove in the proximal end outer surface, or with an annular snap ring, or with screw threads or other easily attachable and detachable mechanisms.
  • the lighting assembly may instead be directly fixed to the proximal end of the cannula tube or fixed on the ring 18 which in turn is fixed to the cannula tube (as shown in Figure 5 through 8).
  • the cannula tube is characterized by a distal end 2d and a
  • the cannula tube most conveniently has a circular radial cross section, but the radial cross section may be varied to provide for access to particular surgical sites.
  • the cannula tube may consist of an opaque material, non-transmissive to visible light, such as metal, or it may comprise an opaque construction including a luminal surface comprising an opaque material which is non-transmissive to visible light in a cannula tube of transmissive or non
  • transmissive material for example, an acrylic tube with a metallic coating
  • the lighting assembly 3 is disposed proximate the proximal end of the cannula tube, and is configured to hold light 5 proximal to the proximal opening of the cannula tube (this is preferable, but the lights may extend slightly distally into the lumen) to project light into the lumen of the cannula tube.
  • the cannula tube may consist of an opaque material, non-transmissive to visible light, and is preferably made of metal such as stainless steel or aluminum.
  • the effectiveness of the lighting is preferably enhanced by providing a very smooth surface on the inner wall of the cannula tube.
  • the luminal surface is highly polished/smooth with an Average Roughness of 8 micro inches or smoother ( 8 -6 inches, equivalent to Ra (urn) 0.2 (0.2 microns), USA #8 finish, Japan Buff #300, or ISO N4 or
  • the lights of Figure 1 may have a total output of 200 to 700 lumens, which, in combination with the smooth luminal surface, will provide in ample light at a surgical workspace at the distal end of the cannula tube. Combinations of slightly rougher surfaces with higher power lights may be used.
  • the luminal surface may be provided in a Average Roughness in the range of 9 to 32 micro-inches (between 0.22 to 0.81
  • the luminal surface may be provided in a
  • Average Roughness in the range of 33 to 63 micro-inches (0.82 to 1.6 micrometers, ISO N7 finish, USA #3 or #4 finish) and the lights may be chosen to provide additional lumens, in the higher end of the range.
  • main beam axis 9 which may be directed at an angle oci of 70° to 85°, though preferably about 80°
  • the cannula has a distal portion with a straight inner bore (of consistent diameter throughout the length of the distal portion) and a proximal conical section with a conical bore which is larger than the diameter of the straight inner bore at the proximal end of the proximal conical section and necks down to match the diameter of the straight inner bore of the straight distal portion .
  • main beam axis 9 which may be directed at an angle oci of 80° from the radial axis 2R, directed distally, or at an angle Bi of 10° relative to the luminal surface of the cannula tube (toward the center of the lumen).
  • Figures 1 and 2 illustrate the system with a cannula tube having a conical lumen in a proximal portion of the cannula tube
  • the cannula tube may be isodiametric
  • Figure 3 is a view of the cannula system from the bottom, or distal end of the cannula tube.
  • the beam axis 9 may be aimed to intersect the central axis 2C of the cannula tube, or the beam axis may be aimed at angle g from the radian 2R (the line between the LED and the central axis 2C, or, along a chord of the circle defined by the cannula tube). This angle is preferably in the range of about 10 to 30°.
  • the light source may consist of only two LED's disposed over (proximal to) the proximal end of the cannula tube, either directly or on the ring 6 and separated by a first arc a 2 of 50° to 70°, and preferably about 60° as shown in Figure 3 (or, conversely, the second arc b 2 of 290° to 310°, and preferably about 300° as shown in Figure 3).
  • the light source may consist of two pairs of closely spaced lights, with the pairs similarly separated.
  • the lights and any associated lenses are disposed proximal to the proximal opening of the cannula tube without extending distally into the lumen.
  • the proximal end of the cannula tube has an inner bore/lumen that is conical, with a proximal opening slightly larger than the diameter of the distal portion of the cannular tube.
  • the cannula system may include a camera assembly 10 secured to the proximal end of the cannula, with a portion of the camera assembly overhanging the lumen and extending into a cylindrical space defined by the lumen of the cannula tube.
  • the camera assembly has a distal- most optical surface, which may be a distal surface of an objective lens or a prism (the prism 11 is shown in Figure 2, and the distal-most optical surface 12 is visible in the distal view of Figure 3 ) , and the distal-most optical surface is disposed proximate the proximal end of the cannula tube.
  • the objective lens or prism may be the portion of the camera assembly overhanging the lumen.
  • the distal-most optical surface of the camera system is spaced proximally from the proximal end of the cannula tube in the illustration, but may be placed a short distance distal to the very proximal edge of the cannula tube (without extending to the distal end of the cannula tube).
  • the cannula system can include a tab 13 for securing the cannula to a table-fixed flex arm.
  • the distal most optical surface of the camera assembly is disposed between the lights, in the smaller arc a 2 separating the two lights.
  • a gap in the housing, between the two lights (or two pairs of lights), provides an unobstructed sight-line between the distal-most optical surface and the workspace at the distal end of the cannula tube, and the distal most optical surface of the camera assembly is disposed within this gap or proximal to the gap .
  • Figure 5 illustrates a second version of the cannula system for accessing a target site in the body of a patient.
  • the cannula system 14 of Figure 5 comprises a cannula tube 15 and a lighting assembly 16 disposed proximate the proximal end of the cannula tube.
  • the lighting assembly 16 comprises a number of lights 17 (LED's, incandescent bulbs, etc.) mounted on a ring 18 as illustrated (though a partial ring may be used, or the ring may be omitted), and may be permanently fixed or releasably attachable to the proximal end of the cannula tube, through releasable attachment means such as an annular snap ring, a threaded fitting (or a C-ring expandable to engage a groove in the proximal end outer surface).
  • releasable attachment means such as an annular snap ring, a threaded fitting (or a C-ring expandable to engage a groove in the proximal end outer surface).
  • the cannula tube is characterized by a distal end 15d and a proximal end 15p, and a lumen 19 extending from the proximal end to the distal end, a central longitudinal axis 15L defined by the lumen, and a luminal surface 20 on an inner wall of the cannula tube.
  • the inner diameter of the cannula tube proximal end 15p is longitudinally isodiametric (straight-walled, and not conical as in Figure 2 )
  • the inner diameter of the cannula tube distal end 15d is longitudinally isodiametric
  • the inner diameter of the cannula tube distal end is smaller than the inner diameter of that cannula tube proximal end, and the cannula tube proximal end 15p and cannula tube distal end 15d are joined by a neck-down portion 15N of the cannula tube.
  • the lighting assembly 16 of Figure 5 is disposed proximate the proximal end of the cannula tube, and is configured to project light into the lumen of the cannula tube.
  • the cannula tube may consist of an opaque material, non-transmissive to visible light, again preferably metal such as stainless steel or aluminum.
  • the luminal surface is highly polished/smooth with a Average Roughness less that 8 micro inches, to enhance the transmission of light from the proximal end of the cannula to the distal end of the cannula and a target site beyond the distal end of the cannula.
  • the lights of Figure 5 may have a total output of 1500 to 2500 lumens, which, in combination with the smooth luminal surface, will provide in ample light at a surgical workspace at the distal end of the cannula tube.
  • the lights may be chosen to provide additional lumens, in the higher end of the range, with luminal walls of Average Roughness within the range of 9 to 32 micro-inches or in the range of 33 to 63 micro-inches.
  • the lighting assembly 16 may comprise a plurality of LED's 17 disposed on the proximal end of the cannula tube, either directly fixed to the proximal end of the cannula tube or fixed on the ring 18 which in turn is fixed to the cannula tube.
  • the ring 18 may be permanently fixed or releasably attachable to the proximal end 15p of the cannula tube, through releasable attachment means such as a Co ring expandable to engage a groove in the proximal end outer surface, or with an annular snap ring, or with screw threads or other easily attachable and detachable mechanisms.
  • the lights 17 are characterized by a main beam axis 21, which may be directed parallel to the straight side wall or the portion of the luminal surface on the inner wall of the proximal end of the cannula tube (that is, the beam axes of each LED may be parallel to a portion of the luminal surface on an inner wall of the cannula).
  • the main beam axis 21 may also be directed at an angle oci of 70° to 85°, though preferably about 80° downward (distally) from the radial axis 2R, or, comparably, directed at an angle Bi of 5° to 15°, and preferably about 10° relative to the luminal surface of the cannula tube (toward the center of the lumen).
  • the cannula system of Figure 5 may include a camera assembly 10 secured to the proximal end of the cannula, with a portion of the camera assembly overhanging the lumen and extending into a cylindrical space defined by the lumen of the cannula tube.
  • the camera assembly has a distal-most optical surface, which may be a distal surface of an objective lens or a prism, and the distal-most optical surface is disposed proximate the proximal end of the cannula tube, the objective lens or prism may be the portion of the camera assembly overhanging the lumen.
  • the distal-most optical surface of the camera system is spaced proximally from the proximal end of the cannula tube in the illustration, but may be placed a short distance distal to the very proximal edge of the cannula tube .
  • Figures 8 illustrates a lighted cannula system with a cannula tube of non-uniform diameter, with a proximal light source consisting of two LED's 5.
  • Figure 8 illustrates that the cannula tube of Figure 5 can be combined with the two-LED light source of Figures 1 through 4, to obtain the benefits of the larger proximal lumen in a system using a light source consisting of two LED's.
  • the two LED's (or two pairs) can be aimed directly distally, with the beam axes parallel to the side wall of the cannula tube, as with Figure 7, or the beam axes may be angled toward the center of the lumen, as with Figure 2.
  • the extreme smoothness of the luminal surface provides for abundant reflection of light from the proximal light sources into the cannula distal end and minimization of shadows cast by tools disposed within the cannula lumen, without the need to resort to more complex tube constructions such as optical fibers embedded in the cannula wall, or optical transmission of light from a light ring into a
  • the cannula tube can comprise a transparent material, it is more conveniently made of metal, such as stainless steel or aluminum, which can be made with thinner walls vis-a-vis plastics, and can be sterilized and re-used, and is not subject to abrasion or skiving from abrading tools (more of a concern for spinal surgery).
  • the cannula tube can consist of an opaque material, preferably metal, without embedded optical fibers or wave guide features.
  • the cannula tube can also consist of a transparent polymer, without embedded optical fibers or wave guide features, though the transparency of the tube is not necessary to obtain the advantages of the inventive features of the cannula system.
  • the cannula tube can be made of other materials, with a highly reflective material adhered to the luminal walls, which will also provide for good light
  • the luminal surface of the cannula tube may be coated to enhance performance in various aspects.
  • the luminal surface may be coated with parylene or other dielectric compound for use in surgeries that require delivery of ablation energy through tools to be inserted into a surgical workspace through the cannula tube.
  • the luminal surface may be coated with a hydrophobic coating, or a lipophobic or oleophobic coating, to minimize build-up of body fluids or irrigation fluids during use.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Biophysics (AREA)
  • Radiology & Medical Imaging (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Microelectronics & Electronic Packaging (AREA)
  • Endoscopes (AREA)
PCT/US2020/017276 2019-02-08 2020-02-07 Lighted cannula system Ceased WO2020163753A1 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
KR1020217028119A KR20210114068A (ko) 2019-02-08 2020-02-07 조명 캐뉼라 시스템
JP2021544202A JP7633934B2 (ja) 2019-02-08 2020-02-07 照明付きカニューレ・システム
CN202080012514.2A CN113423349A (zh) 2019-02-08 2020-02-07 带有照明的套管系统
EP20752885.2A EP3920815B1 (en) 2019-02-08 2020-02-07 Lighted cannula system
CA3127963A CA3127963A1 (en) 2019-02-08 2020-02-07 Lighted cannula system
AU2020219357A AU2020219357B2 (en) 2019-02-08 2020-02-07 Lighted cannula system

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962803276P 2019-02-08 2019-02-08
US62/803,276 2019-02-08

Publications (1)

Publication Number Publication Date
WO2020163753A1 true WO2020163753A1 (en) 2020-08-13

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Application Number Title Priority Date Filing Date
PCT/US2020/017276 Ceased WO2020163753A1 (en) 2019-02-08 2020-02-07 Lighted cannula system

Country Status (8)

Country Link
US (1) US12016534B2 (enExample)
EP (1) EP3920815B1 (enExample)
JP (1) JP7633934B2 (enExample)
KR (1) KR20210114068A (enExample)
CN (1) CN113423349A (enExample)
AU (1) AU2020219357B2 (enExample)
CA (1) CA3127963A1 (enExample)
WO (1) WO2020163753A1 (enExample)

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JP2023010634A (ja) 2021-07-07 2023-01-20 ニコ コーポレイション 可撓性器具送達デバイス
US11723641B2 (en) * 2021-08-03 2023-08-15 Viseon, Inc. Camera system for use with retractors
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AU2020219357B2 (en) 2025-03-20
CN113423349A (zh) 2021-09-21
JP7633934B2 (ja) 2025-02-20
CA3127963A1 (en) 2020-08-13
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KR20210114068A (ko) 2021-09-17
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