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
  • A61B1/04—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
  • A61B1/05—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 the image sensor, e.g. camera, being in the distal end portion
• • 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
  • A61B1/00163—Optical arrangements
  • A61B1/00174—Optical arrangements characterised by the viewing angles
  • A61B1/00179—Optical arrangements characterised by the viewing angles for off-axis viewing
• • 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
  • A61B1/0623—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 off-axis 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
  • A61B1/0676—Endoscope light sources at distal tip of an endoscope

Definitions

• the present invention relates to an endoscope assembly. More particularly, the invention relates to an auxiliary endoscopic imaging catheter and a method of performing a medical procedure.
• An endoscope is a medical or industrial device comprising a flexible or rigid tube and a camera or fiber optics mounted on the distal end of the tube.
• the endoscope is insertable into an internal body cavity through a body orifice or a surgical incision to examine the body cavity and tissues as part of a diagnosis or therapeutic procedure.
• the tube of the endoscope has one or more longitudinal channels, which may be used for irrigation, or suction, or through which an instrument can reach the body cavity to take samples of suspicious tissues or to perform other surgical procedures such as polypectomy, tissue ablation or localized drag delivery.
• endoscopes There are many types of endoscopes, and they are named in relation to the organs or areas with which they are used.
• gastroscopes are used for examination and treatment of the esophagus, stomach, and duodenum;
• colonoscopes are used for examination and treatment of the colon; bronchoscopes are used for examination and treatment of the lungs and bronchi; laparoscopes are
• sigmoidoscopes are used for examination and treatment of the rectum and the sigmoid colon;
• arthroscopes are used for examination and treatment of joints; cystoscopes are used for examination and treatment of the urinary bladder; ureteroscopes are used for examination and treatment of the ureters and kidneys; and angioscopes are used for examination and treatment of blood vessels.
• Many conventional endoscopes include a single forward-viewing fiber bundle or a camera mounted at the distal end of the endoscope that captures and transmits an image to an eyepiece, in the case of fiber bundle, or to a video display monitor at the proximal end.
• the image is used to assist a medical professional in advancing the endoscope into a body cavity and looking for abnormalities.
• the camera provides the medical professional with a two-dimensional view from the distal end of the endoscope.
• the endoscope To capture an image from a different angle or in a different portion of the endoscope, the endoscope must be maneuvered, repositioned, articulated, or moved back and forth. All these maneuvers of the endoscope prolong the procedure and cause added discomfort, complications, and risks to the patient.
• flexures, tissue folds, and unusual geometries of the organ may prevent the endoscope's forward-looking camera from viewing behind tissue folds, flexures, and other "hidden” areas of the lumen.
• the inability to view behind the folds, flexures, and other "hidden” areas may cause a potential polyp to be missed during colonoscopy.
• an endoscopic imaging catheter comprising: a longitudinally extending shaft having a proximal end, a distal end, and an outer surface, wherein the distal end comprises a portion that is transparent;
• a proximally facing reflective element positioned within the distal end of the shaft
• an imaging element positioned within the distal end of the shaft and in communication with the reflective element
• imaging element in the distal end of the shaft can obtain images of up to 360°, preferably 360°, around the distal end of the shaft and in a proximal or substantially proximal direction.
• auxiliary endoscopic imaging catheter for insertion via a longitudinal working channel in an endoscope or an endoscopic insertion tube, comprising:
• a longitudinally extending shaft having a proximal end, a distal end, and an outer surface, wherein the distal end comprises a portion that is transparent;
• a proximally facing reflective element positioned within the distal end of the shaft
• an imaging element positioned within the distal end of the shaft and in communication with the reflective element
• imaging element in the distal end of the shaft can obtain images of up to 360°, preferably 360°, around the distal end of the shaft and in a proximal or substantially proximal direction.
• the present invention provides for a retrograde or rear view that augments the forward-looking view of a conventional endoscope.
• This embodiment provides for a rear-looking video camera and a light source, mounted on the distal end of an endoscopic insertion tube, that together provide for an auxiliary endoscopic imaging catheter.
• the auxiliary endoscopic imaging catheter is designed to be insinuated into a channel of a conventional endoscope and to exit from the distal opening of the channel of the conventional endoscope.
• the endoscope is an auxiliary endoscopic imaging catheter.
• the endoscope assembly includes a main endoscope that includes an insertion tube, a forward- viewing imaging device mounted at a distal end area of the insertion tube, and a channel extending through the insertion tube.
• the auxiliary endoscopic imaging catheter extends through the channel of the insertion tube of the main endoscope and exits from a distal opening of the channel of the insertion tube.
• the auxiliary endoscopic imaging catheter is moveable along the channel of the main endoscope to adjust the distance between the camera and light source of the auxiliary endoscopic catheter and the camera and light source of the main endoscope in order to avoid optical interaction or cross-talk between them.
• the camera of the auxiliary endoscopic imaging catheter allows for capturing at least a portion of a fold, flexure, or other area "hidden" to a forward-looking main endoscope, without maneuvering or articulating the tip of the main endoscope.
• parts or the entire auxiliary endoscopic imaging catheter are disposable and or replaceable
• the auxiliary endoscopic imaging catheter is flexible and does or does not include a steering or articulation mechanism.
• an auxiliary endoscopic imaging catheter for insertion via a longitudinal channel of a main endoscope's insertion tube comprises a distal head which includes a rear view camera and light source.
• the rear view camera includes optical components including a mirror, which without any movement, continuously reflects to the camera the surface of the cavity located behind to the side and optionally in front of the camera.
• the present invention in certain embodiments thereof, relates to a method and an apparatus for intrabody imaging and, more particularly, but not exclusively, to a method and an endoscope for imaging to the side of the endoscope.
• an endoscopic imaging catheter which is optionally designed to be inserted via a working channel of an endoscopic insertion tube, and which allows the imaging of walls which encircle an intrabody lumen.
• this catheter is used for imaging portions of the wall which are outside the view of a camera provided with the endoscope insertion tube, for example, portions of which are behind the view of such camera.
• both an insertion tube imager and a catheter imager are used together to image different and possibly overlapping parts of the intrabody lumen, optionally simultaneously.
• illumination is shared between the two imaging systems.
• the imaging catheter includes an illumination guide or means.
• such illumination means is arranged so that it does not directly illuminate the imaging system of the imaging catheter.
• the imaging catheter imaging system is arranged so that it is not directly illuminated by an illumination means of the endoscope, for example, if the catheter is advanced a sufficient amount.
• this direct illumination is prevented by recessing one or more parts of the imaging system of the imaging catheter so that the body of the imaging catheter blocks light from the illumination means of the endoscope.
• the illumination is reflected, for example, using a mirror, towards the wall of the intrabody lumen, optionally to overlap with a visual field of the endoscopic imaging catheter.
• the endoscopic imaging catheter is covered with a protective sheath, optionally disposable.
• a sheath which is optionally made from a relatively inexpensive, transparent material such as polyethylene terephthalate (PET) or polycarbonate, allows using the endoscopic imaging catheter in multiple procedures, with multiple patients, without having to perform time consuming disinfective reprocessing procedures.
• PET polyethylene terephthalate
• Such a sheath may reduce the price of each one of the procedures.
• such a sheath is designed for a single use to reduce the risk of patient to patient cross contamination.
• the sheath may tear when removed or may be elastic and provided in everted form or rolled-up for mounting on the imaging catheter.
• the endoscopic imaging catheter is sized and shaped so that it can be used with a plurality of different endoscope insertion tube designs.
• the imaging catheter includes an imaging element and an optional image axis changing element (e.g., a mirror).
• these elements are aligned along the longitudinal axis of the shaft.
• the imaging element and/or mirror are arranged to
• an auxiliary endoscopic imaging catheter of the invention for insertion via a working or longitudinal channel of an endoscopic insertion tube, the catheter comprises:
• optical element and the imaging element are capable of capturing an image of up to 360° of the side and rearward-looking views of a corporeal wall encircling an intrabody lumen.
• the optical element comprises a reflecting optical element that is distal or proximal in relation to said imaging element when the catheter exits the longitudinal channel.
• the optical element is distal or proximal in relation to said imaging element when the catheter exits the longitudinal channel.
• the catheter further comprises an illumination source located proximal or distal to the imaging element.
• the illumination source is structured and mounted as a 360° ring thus illuminating the side, rear, and optionally front field of view of said imaging element, approximately 360° around the longitudinal axis of the auxiliary endoscopic imaging catheter.
• an illumination source is located proximal or distal to the optical element.
• the illumination source is structured and mounted as a 360° ring thus illuminating the side, rear, and optionally front field of view of said imaging element, approximately 360° around the longitudinal axis of the auxiliary endoscopic imaging catheter.
• an illumination source is attached to one end of a rotatable wire.
• rotating or wobbling of said rotatable wire in its other end around its long axis allows rotating or wobbling said illumination source to cover a motion of 360° around the longitudinal axis of the auxiliary endoscopic imaging catheter, allowing the illumination of said side and rear view or at least a portion, of the entire 360° view of a wall encircling an intrabody lumen, which is located behind the imaging element, around the axis of said the longitudinal channel.
• an illumination source comprises a single light source or a plurality of light sources.
• the illumination source comprises one or more LEDs.
• said endoscopic insertion tube is capable of performing a procedure from a group consisting of anoscopy, arthroscopy, bronchoscopy, colonoscopy, cystoscopy, esophagogastro-duodenoscopy (EGD), laparoscopy, and sigmoidoscopy.
• a system comprises an endoscopic imaging catheter and a sheath sized and shaped to cover said the auxiliary endoscopic imaging catheter.
• the method comprises:
• first and second images of the intrabody lumen and a segment of an inner wall encircling said intrabody lumen can be captured.
• first and second images are captured substantially simultaneously.
• the catheter comprises:
• optical element and the imaging element are capable of capturing an image of up to 360° of the side and rearward-looking views of a corporeal wall encircling an intrabody lumen and wherein the illumination source comprises a 360° ring capable of illuminating up to 360° around a longitudinal axis of the catheter.
• the optical element comprises a reflecting optical element that is distal in relation to said imaging element when the catheter exits the longitudinal channel.
• the optical element is distal in relation to said imaging element when the catheter exits the longitudinal channel.
• the illumination source is located proximal to the imaging element.
• the illumination source is structured and mounted as a 360° ring thus illuminating the side, rear, and optionally front field of view of said imaging element, up to 360° around the longitudinal axis of the auxiliary
• the illumination source is located proximal to the optical element.
• the illumination source is structured and mounted as a 360° ring thus illuminating the side, rear, and optionally front field of view of said imaging element, up to 360° around the longitudinal axis of the auxiliary
• the illumination source is attached to one end of a rotatable wire.
• rotating or wobbling of said rotatable wire in its other end around its long axis allows rotating or wobbling said illumination source to cover a motion of 360° degrees around the longitudinal axis of the auxiliary endoscopic imaging catheter, allowing the illumination of said side and rear view or at least a portion, of the entire 360° view of a wall encircling an intrabody lumen, which is located behind the imaging element, around the axis of said the
• the illumination source comprises a single light source or a plurality of light sources.
• the illumination source comprises one or more LEDs.
• the endoscopic imaging catheter is capable of performing a procedure from a group consisting of anoscopy, arthroscopy, bronchoscopy, colonoscopy, cystoscopy, esophagogastro-duodenoscopy (EGD), laparoscopy, and sigmoidoscopy.
• a procedure from a group consisting of anoscopy, arthroscopy, bronchoscopy, colonoscopy, cystoscopy, esophagogastro-duodenoscopy (EGD), laparoscopy, and sigmoidoscopy.
• a system comprises an endoscopic imaging catheter and a sheath sized and shaped to cover said endoscopic imaging catheter.
• FIG. 1 is a schematic of one embodiment of an auxiliary endoscopic imaging catheter of the invention
• FIG. 2 is a schematic of another embodiment of an auxiliary endoscopic imaging catheter of the invention.
• FIGs. 3 and 4 are each an oblique view of a distal section of an auxiliary endoscope imaging catheter according to the invention.
• FIG. 1 is a schematic representation of the distal portion of an auxiliary endoscopic imaging catheter 2, according to one embodiment of the present invention.
• Auxiliary endoscopic imaging catheter 2 is shown exiting a working channel 4 of a primary endoscope 6.
• a forward-looking field of view 10 of primary endoscope 6 is augmented by a side and rearward-looking field of view 12 of auxiliary endoscopic imaging catheter 2. Both fields of view 10 and 12 are 360° around the longitudinal axis (not shown) of primary endoscope 6 and auxiliary endoscopic imaging catheter 2, respectively.
• Auxiliary endoscopic imaging catheter 2 includes illumination component 16, which illuminates 360° around catheter 2 and correlates with the field of view 12 of auxiliary endoscopic imaging catheter 2.
• auxiliary endoscopic imaging catheter 2 The side and rearward-looking field of view 12 of auxiliary endoscopic imaging catheter 2 is enabled by a distal mirror or lens 20, which reflects the side and rearward-looking image onto the imaging element or camera 22.
• Imaging element or camera 22 transmits electronic signals comprising the images through wire 24 to a camera control unit (not shown).
• the camera control unit converts the electronic signals to video images which may be displayed on a monitor (not shown).
• a tissue fold 30 has a growth 32 (possibly a polyp), which is located on the distal side 34 of fold 30.
• Growth 32 is outside of, and cannot be seen or detected by, forward-looking field of view 10 of main endoscope 6. However, it is within, and thus can be seen and detected by, the side and rear looking field of view 12 of auxiliary endoscopic imaging catheter 2.
• FIG. 2 is a schematic representation of the distal portion of an auxiliary endoscopic imaging catheter 42, according to another embodiment of the present invention.
• Auxiliary endoscopic imaging catheter 42 is shown exiting a working channel 44 of a primary endoscope 46.
• a forward-looking field of view 50 of primary endoscope 46 is augmented by a side and rearward-looking field of view 52 of auxiliary endoscopic imaging catheter 42. Both fields of view 50 and 52 are 360° around the longitudinal axis (not shown) of primary endoscope 46 and auxiliary endoscopic imaging catheter 42, respectively.
• Auxiliary endoscopic imaging catheter 42 includes illumination component 56, which illuminates 360° around catheter 42 and correlates with the field of view 52 of auxiliary endoscopic imaging catheter 42.
• the side and rearward-looking field of view 52 of auxiliary endoscopic imaging catheter 42 is enabled by an imaging element or camera 62, which receives the side and rearward-looking image.
• Imaging element or camera 62 transmits electronic signals comprising the images through wire 64 to a camera control unit (not shown).
• the camera control unit converts the electronic signals to video images which may be displayed on a monitor (not shown).
• a tissue fold 70 has a growth 72 (possibly a polyp), which is located on the distal side 74 of fold 70. Growth 72 is outside of, and cannot be seen or detected by, forward-looking field of view 50 of main endoscope 46. However, it is within, and thus can be seen and detected by, the side and rear looking field of view 52 of auxiliary endoscopic imaging catheter 42.
• FIG. 3 Schematic representations of distal ends of two different embodiments of the invention are shown in Figs. 3 and 4.
• the distal section 80 of a catheter shaft has a proximally facing mirror or reflective surface 82 spaced apart from a lens or optics system 84 in communication with camera 85, with an illumination ring 86.
• the outer surface 90 of distal portion 80 is transparent in most or all of the space between mirror 82 and lens or optics system 84 or optionally extended and including camera 85 and/or illumination ring 86.
• the outer surface 90 between camera 84 and illumination ring 86 is opaque or translucent.
• the distal section 100 of a catheter shaft has a proximally facing, reflecting mirror or reflective surface 102 spaced apart from a lens 104, with a camera 106 and a light source 108.
• the outer surface 110 of distal portion 100 is transparent in most or all of the space between mirror 102 and lens 104.
• Such standard endoscope may be used in various medical imaging procedures in which an intrabody cavity or lumen is imaged, for example, anoscopy, arthroscopy, bronchoscopy, colonoscopy, cystoscopy, esophagogastro-duodenoscopy (EGD), trans-nasal esophagoscopy (TNE), laryngoscopy, laparoscopy, and sigmoidoscopy.
• anoscopy arthroscopy
• bronchoscopy colonoscopy
• cystoscopy esophagogastro-duodenoscopy (EGD), trans-nasal esophagoscopy (TNE), laryngoscopy, laparoscopy, and sigmoidoscopy.
• a standard endoscope includes an insertion tube whose distal section can optionally be articulated, for example, by an articulation knob (or other control), which may be part of an endoscope control/handle unit.
• the control/handle unit is similar to an endoscopic control handle that is incorporated in a conventional endoscope used for intrabody procedures, such as biopsy.
• the insertion tube may be detachable from the control/handle unit or in permanent connection. The diameter, length and flexibility of the insertion tube may depend on the procedure for which the endoscope is used.
• the endoscope may have one or more working channels, for example, for instrumentation, air insufflation, water irrigation, suction and/or light, for example as commonly used in the art.
• the diameter of the working channel which is integral to the insertion tube thereof may be from about 3 mm to about 4 mm, optionally, from about 3.2 mm to about 4.2 mm.
• the insertion tube may have varying flexibility over its length.
• an endoscopic imaging catheter 2 or 42 as described above is inserted via a biopsy/working channel 4 or 44, longitudinally traversing the insertion tube through the working channel.
• an imaging catheter according to the invention can be integral to the standard endoscope.
• an imaging catheter is sheathed before being inserted into a biopsy/working channel.
• a sheath covers the endoscope (or at least an insertion tube) and includes a channel and/or elongate extension for extension of the imaging catheter therethrough.
• a control handle is provided for manipulation of the imaging catheter, for example, for axial and/or rotational position control and/or for controlling of imaging and/or illumination features thereof.
• the control/handle unit optionally has a plurality of ports, for example, coupled to the biopsy/working channel, which are in communication with one or more channels in the insertion tube. Each port may allow the insertion of an endoscopic imaging catheter.
• an endoscopic imaging catheter may be inserted via a biopsy tool port.
• the insertion tube has an imaging element mounted at a distal end thereof.
• imaging elements include an image sensor, a tip of a fiber optic bundle, a charge coupled device (CCD) based sensor, a complementary metal oxide semiconductor (CMOS) based sensor and/or a radiation sensitive element.
• CCD charge coupled device
• CMOS complementary metal oxide semiconductor
• this imaging element may be referred to herein as a frontal imaging element or as a main imaging element.
• an insertion tube has an illumination source mounted on the distal end thereof (or provided as a separate movable element, e.g., a catheter), for example, one or more light emitting diodes (LEDs) or fiberoptic light bundle(s).
• an illumination source illuminates the field of view of the imaging element (and/or of imaging catheter).
• a control unit is used for controlling and/or aiming frontal imaging element and/or illumination source.
• the cable or another port may be used for providing an illumination channel or fiber bundle that is connected to the frontal illumination source.
• the endoscopic imaging catheter may be extended out past the distal end of insertion tube, under visualization of the frontal/main imaging element. This may increase a safety of such extension.
• a reusable and/or a disposable sheath is placed over an endoscopic imaging catheter before insertion thereof into the intrabody lumen. A potential advantage of a disposable sheath is that it allows reusing the endoscopic imaging catheter multiple times.
• a protective sheath is made of a layer of transparent flexible material, such as polyethylene terephthalate (PET), for example, 120-gauge PET, polyvinyl chloride (PVC), Polyethylene terephthalate copolymer (PETG), polyurethane, or other suitable transparent materials.
• PET polyethylene terephthalate
• PVC polyvinyl chloride
• PETG Polyethylene terephthalate copolymer
• a sheath has a transparent segment that covers the distal end of an endoscopic imaging catheter.
• the rotatable shaft allows rotating an optical element without changing the orientation of the sheath.
• a potential advantage is that, the rotation of an optical element cannot damage the inner walls of an intrabody lumen, e.g., in an embodiment where the optical element is exposed.
• a window is placed over the optical element.
• the entire imaging catheter is rotated for achieving the above described lateral imaging.
• composition or method may include additional ingredients and/or steps, but only if the additional ingredients and/or steps do not materially alter the basic and novel characteristics of the claimed composition or method.
• the singular form “a”, “an” and “the” include plural references unless the context clearly dictates otherwise.
• the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.

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• 2011
  • 2011-05-10 AU AU2011250972A patent/AU2011250972A1/en not_active Abandoned
  • 2011-05-10 US US13/104,832 patent/US8734334B2/en not_active Expired - Fee Related
  • 2011-05-10 KR KR1020127032289A patent/KR20130112709A/ko not_active Withdrawn
  • 2011-05-10 WO PCT/US2011/035984 patent/WO2011143264A1/en not_active Ceased
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  • 2011-05-10 EP EP11781176.0A patent/EP2568868A4/en not_active Withdrawn
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