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
  • A61B1/00064—Constructional details of the endoscope body
  • A61B1/00071—Insertion part of the endoscope body
  • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
  • A61B1/00082—Balloons
• • 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
  • A61B1/012—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 characterised by internal passages or accessories therefor
  • A61B1/015—Control of fluid supply or evacuation
• • 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
  • A61B1/012—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 characterised by internal passages or accessories therefor
  • A61B1/018—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 characterised by internal passages or accessories therefor for receiving instruments
• • 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
• • 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
  • A61B1/00064—Constructional details of the endoscope body
  • A61B1/00103—Constructional details of the endoscope body designed for single use
• • 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
  • A61B1/00131—Accessories for endoscopes
  • A61B1/00135—Oversleeves mounted on the endoscope prior to insertion
• • 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
  • A61B1/3137—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 examination of the interior of blood vessels
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M2025/1043—Balloon catheters with special features or adapted for special applications
  • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/02—Holding devices, e.g. on the body
  • A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible

Definitions

• Endoscopes for example microendoscopes, can be used for imaging and/or to perform minimally-invasive procedures (e.g., surgery).
• Endoscopes can comprise, consist essentially of, or consist of a catheter-based device, and can be designed to permit a health care practitioner such as a physician to visualize and/or treat the internal tissues of a patient through a small incision in the skin.
• An endoscope can include a light source and a camera.
• Some endoscopes (which may be referred to as fiberscopes or fiber-optic endoscopes) can include illumination fibers or light guides that direct light to illuminate the field of view.
• the present disclosure relates to endoscopes and endoscopy systems. More particularly, some embodiments herein relate to methods and endoscopy systems comprising radially-expandable features.
• the radially-expandable features can inhibit, reduce, or prevent fluid flow inside a vessel such as a blood vessel, permitting direct imaging of the inside of the vessel.
• the endoscopy systems are useful for direct visualization of endovascular lumens (without interference from fluid such as blood).
• the endoscopy systems are useful for orthopedic procedures.
• the endoscopy systems are useful for arthroscopic procedures.
• Some embodiments include an endoscope comprising a hub, and a shaft extending from the hub, the shaft having a distal tip.
• An image sensor disposed within the distal tip has a field of view external from the endoscope.
• An illuminating element within the distal tip emits light within the field of view of the image sensor.
• An expandable cuff (such as a radially expandable cuff) disposed on at least a portion of the shaft is moveable between a contracted configuration and a deployed configuration.
• An outer surface of the expandable cuff is disposed further away from a longitudinal axis of the shaft when the expandable cuff is in the deployed configuration than when the expandable cuff is in the contracted configuration.
• the endoscope is configured for use in a specified vessel (e.g., a blood vessel or chamber of the heart), and the expandable cuff, when deployed, in combination with the shaft, occupies all or substantially all of an interior area of a cross section of the vessel.
• a specified vessel e.g., a blood vessel or chamber of the heart
• the expandable cuff and shaft can inhibit, reduce, or prevent fluid flow (e.g., blood flow) in the vessel.
• fluid flow e.g., blood flow
• preventing blood flow can stop the blood flow.
• the deployed expandable cuff in combination with the shaft, occupies at least 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, 99.5%, 99.9%, or 100% of the interior area of the cross section of the vessel.
• the endoscope is configured for use in the specified vessel, and the expandable cuff, when deployed, has an outer diameter that is the same or about the same as an inner diameter of the specified vessel.
• the endoscope is configured for use in the specified vessel, and the expandable cuff, when deployed, has an outer diameter that is within 20%, 15%, 10%, 5%, 4%, 3%, 2%, or 1% of the inner diameter of the specified vessel.
• the deployed expandable cuff is configured to exert a radially-outward force on an inside surface of the specified vessel.
• the expandable cuff is an anchoring sleeve.
• the expandable cuff includes a lumen in fluid communication with the hub. In some embodiments, the expandable cuff moves from the contracted configuration to the deployed configuration when a fluid or gas is introduced into the lumen through the inflation port as described herein.
• the endoscope is configured for use in a specified vessel, in which the expandable cuff, when deployed, has an outer diameter that is about the same or within 20%, 15%, 10%, 5%, 4%, 3%, 2%, or 1% of the inner diameter of the specified vessel. In some embodiments, when the expandable cuff is deployed, the endoscope has an outer diameter sufficient to inhibit, reduce, or prevent fluid flow (such as blood flow) in the specified vessel. In some embodiments, the endoscope is configured for percutaneous access to the specified vessel.
• the endoscope is configured for use in a specified vessel selected from the group consisting of: a femoral artery, a radial artery, a coronary artery, a carotid artery, an aorta, and a pulmonary vein such as the inferior vena cava, a peripheral vein or two or more of the listed items.
• the endoscope is configured to exert a radially-outward force via the expandable cuff on an inside surface of a vessel selected from the group consisting of: a femoral artery, a radial artery, a coronary artery, a carotid artery, an aorta, and a pulmonary vein such as the inferior vena cava, a peripheral vein or two or more of the listed items.
• the deployed expandable cuff can temporarily inhibit, decrease, or prevent blood flow in the vessel, permitting a direct visualization of inside aspects of the vessel.
• the visualization can be performed by the image sensor.
• the endoscope is configured for percutaneous access to an occlusion in a peripheral vessel, such as a leg, foot, ankle, arm, or hand, for example in a diabetic or vasculopathic patient.
• a peripheral vessel such as a leg, foot, ankle, arm, or hand
• the endoscope can be used for direct imaging and procedures for treating peripheral vascular disease.
• the expandable cuff (as disposed on the shaft of the endoscope), when deployed, is configured to inhibit, reduce, or stop fluid flow in the vessel (for example, blood flow in a blood vessel).
• the endoscope can be configured for directly imaging the interior of the vessel (e.g., without interference from fluid such as blood).
• the target location comprises a peripheral artery
• the vessel is the peripheral artery.
• the endoscope is configured to access the foot via the femoral artery, for example for treatment of an extremity vascular occlusion in a diabetic patient.
• the endoscope is configured to access the brain via the radial artery (it is contemplated that such an endoscope will have a suitable length to reach the brain via the radial artery), for example to deliver an instrument or perform imaging or a surgical procedure in the brain.
• the expandable cuff includes two or more portions circumferentially disposed around the shaft.
• the endoscope further comprises a working channel disposed within the shaft and extending from the hub to the distal tip. At least a portion of the working channel is disposed between the longitudinal axis of the shaft and an overlying portion of the expandable cuff.
• the overlying portion of the expandable cuff comprises an inner surface disposed between the working channel and an internal space of the expandable cuff, with the inner surface being less distensible than the outer surface.
• the internal space of the expandable cuff includes a plurality of inflation channels with each of the plurality of inflation channels being fluidically isolated from one another.
• the expandable cuff has a longitudinal length of at least about 2 centimeters, for example less than about 2, 1.5, 1, 0.5, 0.2, or 0.1 centimeters.
• the endoscope includes a mitral clip, and the endoscope is configured for use in the inferior vena cava.
• the endoscope includes a mitral clip, and the endoscope is configured to deploy the mitral clip in the heart percutaneously.
• the endoscope is for vascular access to the heart, for example via the inferior vena cava.
• trans-vascular access to the heart can facilitate direct visualization of the target tissue.
• the endoscope is configured for deployment of the expandable cuff in the inferior vena cava so that the outer diameter is about the same or within 20% of the inner diameter of the inferior vena cava, thus inhibiting, or stopping blood flow in the inferior vena cava.
• the endoscope is configured to exert a radially-outward force on an inside surface of the inferior vena cava.
• the deployed cuff immobilizes the endoscope in the inferior vena cava.
• the method of deploying a mitral clip in the heart comprises advancing the endoscope through the heart, deploying the expandable cuff in the inferior vena cava (so that the endoscope is immobilized in the inferior vena cava), visualizing the target tissue with the image sensor of the endoscope, and deploying the mitral clip. It is contemplated that in some embodiments, advancing the endoscope through the aorta and/or via a puncture of the heart apex (instead of trans-vascularly) can also be used to access the heart and deploy the mitral clips. In some embodiments, the endoscope is configured to ablate the pulmonary vein using electrocautery or cryotherapy.
• the target tissue is visualized in the absence of blood flow.
• the endoscope comprising the expandable cuff in the deployed configuration can inhibit, reduce, or stop the blood flow so as to permit the visualization.
• the endoscope is a microendoscope.
• Some embodiments include a method of imaging an interior of a vessel (for example a blood vessel or chamber of the heart).
• the method can comprise advancing an endoscope within a vessel to a target location.
• the endoscope can be an endoscope comprising an expandable cuff as described herein.
• the endoscope comprises a hub, a shaft extending from the hub and comprising a distal tip, an image sensor within the distal tip, the image sensor having a field of view external from the endoscope, and an expandable cuff disposed on at least a portion of the shaft, the expandable cuff being movable between a contracted configuration and a deployed configuration.
• An outer surface of the expandable cuff can be disposed further away from a longitudinal axis of the shaft when the expandable cuff is in the deployed configuration than when the expandable cuff is in the contracted configuration.
• the method can comprise expanding the expandable cuff of the endoscope so that the expandable cuff and at least the portion of the shaft occupy all or substantially all of an interior area of a cross section of the vessel, so that fluid flow in the vessel is inhibited, reduced, or prevented.
• the method can comprise collecting an image of the interior of the vessel at the target location while the fluid flow is inhibited, in which the image is sensed by the image sensor. In some embodiments, inhibiting, reducing, or preventing fluid flow in the vessel is effective to permit visualization of the interior of the vessel.
• the deployed expandable cuff in combination with the shaft, occupies at least 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, 99.5%, 99.9%, or 100% of the interior area of the cross section of the vessel.
• the endoscope is configured for use in the specified vessel, and the expandable cuff, when expanded, has an outer diameter that is the same or about the same as an inner diameter of the specified vessel.
• expanding the expandable cuff comprises introducing a fluid into an internal space of the expandable cuff.
• the vessel is selected from the group consisting of the femoral artery, radial artery, superior vena cava, aorta, and pulmonary vein.
• the target location comprises a peripheral artery, and wherein the vessel is the peripheral artery.
• the target location is selected from the group consisting of a heart, a brain, a leg, a foot, an ankle, an arm, or a hand.
• the method comprises percutaneous advancing the endoscope to the vessel and target area.
• the endoscope further comprises a working channel, and the method further comprises deploying an instrument from the working channel of the endoscope.
• At least a portion of the working channel can pass between the expandable cuff and a longitudinal axis of the endoscope.
• deploying the instrument comprises distending an inner surface of the expandable cuff with an outer surface of the working channel.
• the instrument comprises a mitral clip.
• the vessel can be selected from the group consisting of the inferior vena cava and the aorta.
• the target location comprises the heart, and the vessel is the inferior vena cava, and the method further comprises visualizing tissue of the heart while the expandable cuff is expanded in the inferior vena cava.
• the mitral clip can be applied to the heart after the visualizing.
• the instrument ablates a portion of a pulmonary vein.
• the endoscope further comprises an illuminating element within the distal tip.
• the illuminating element can be configured to emit light within a field of view of the image sensor.
• the method can further comprise illuminating the interior of the vessel at the target location with the illuminating element.
• advancing comprises moving the endoscope along a guidewire toward the target location.
• advancing further comprises halting the endoscope along the guidewire, and expanding the expandable cuff (so that the expanded expandable cuff and shaft inhibit, reduce, or prevent blood flow in the vessel), and imaging (via the image sensor) a field of view in the vessel while the blood flow is inhibited, reduced, or prevented.
• the method can further comprise contracting the expandable cuff, and resuming moving the endoscope toward the target location along the guidewire.
• the vessel is the radial artery or femoral artery.
• the vessel is the coronary artery, and the target location comprises a portion of the coronary artery comprising an obstruction.
• the method further comprises removing fluid and/or tissue from the interior of the vessel prior to imaging. For example, fluid and/or tissue can be aspirated through one or more working channels of the endoscope as described herein. For example, the vessel can be flushed prior to imaging.
• Some embodiments include an endoscopy system comprising an endoscope as described herein, a guidewire, and an inflation pump.
• the endoscope comprises an image sensor disposed within a distal tip of the endoscope. In some embodiments, the endoscope further comprises an illuminating element disposed within the distal tip and an expandable cuff disposed on an outer surface of the endoscope.
• the guidewire can be sized to pass through a lumen of the endoscope.
• the inflation pump can be in fluid communication with an internal space of the expandable cuff.
• FIGURE 1 is a schematic diagram of an endoscopy system in accordance with some embodiments herein.
• FIGURE 2A is an end view of a distal tip of an endoscope comprising a working channel in accordance with some embodiments herein.
• FIGURE 2B is a cross- sectional side view of a distal tip of an endoscope comprising a working channel in accordance with some embodiments herein.
• FIGURES 3A-3D is a side view of a distal tip of an endoscope comprising an expandable cuff in accordance with some embodiments herein.
• FIGURES 4A-4E is an end view of a distal tip of an endoscope comprising an expandable cuff in accordance with some embodiments herein.
• FIGURE 5 is a schematic diagram of an endoscopy system comprising a tool adapted to extend past a distal end of the working channel in accordance with some embodiments herein.
• FIGURE 6 is a partial side view of a distal tip of an endoscope comprising an expandable cuff in accordance with some embodiments herein.
• FIGURE 7 is a schematic illustration of a use of an endoscope of the present disclosure to perform a medical procedure on a tricuspid valve of a heart in accordance with some embodiments herein.
• FIGURES 8A-8B are schematic illustrations of a use of an endoscope of the present disclosure to perform a medical imaging procedure on a vessel in accordance with some embodiments herein.
• endoscopes such as microendoscopes
• endoscopy systems and methods of using the same.
• visualization of the interior of vasculature has been indirect, for example via X-ray or ultrasound.
• the presence of fluid in vessels has conventionally limited direct imaging of the interior of vasculature, and thus can also limit the availability of surgical procedures that can be performed in the vessel.
• endoscopes and endoscopy systems useful for direct imaging of the inside of a vessel (such as a blood vessel), and/or performing surgical procedures in the vessel and/or procedures that involve passing the endoscope through the vessel.
• the endoscope comprises a shaft having an image sensor within a distal tip of the shaft.
• the shaft can have an expandable cuff disposed on an outer surface of the shaft.
• the expandable cuff can be moved from a contracted configuration to a deployed configuration. With the expandable cuff in the deployed configuration, the expandable cuff and shaft can occupy all or substantially all of an interior area of a cross section of the vessel, thus inhibiting or preventing the flow of fluid (e.g., blood) in the vessel.
• Inhibiting, reducing, or preventing the flow of fluid can reduce or eliminate fluid downstream (relative to the fluid flow) of the expandable cuff, thus permitting direct visualization of the interior of the vessel by the image sensor without interference from the fluid.
• the expandable cuff can be moved back to the contracted configuration.
• the endoscope comprises a shaft and an expandable cuff disposed around at least a portion of the shaft.
• An outer surface of the expandable cuff can be disposed further away from a longitudinal axis of the shaft when the expandable cuff is in a deployed configuration than when the expandable cuff is in a contracted configuration.
• the expandable cuff can be deployed while the endoscope is inside of a vessel (such as a blood vessel).
• the shaft and deployed expandable cuff can occupy all or substantially all of an interior area of a cross section of the vessel.
• the microendoscope with the expandable cuff in the deployed configuration can thus inhibit, reduce, or stop fluidic flow (such as blood flow) inside the vessel, thus permitting visualization of the interior of the vessel and/or surgical procedures in the vessel.
• an endoscope or portion thereof e.g., a shaft portion and deployed expandable cuff
• occupying“substantially all” of an interior area of a cross section of the vessel refers to occupying an interior area of the cross section of the vessel effective to inhibit, reduce, or prevent fluidic flow (such as blood flow) through the cross section, so as to permit visual imaging of the interior of the vessel without interference from fluid downstream (relative to fluid flow) of the occupied interior area of the vessel.
• all or substantially all of the interior of the cross section of the vessel can be occupied in one, or more than one cross sections along the longitudinal axis of the vessel so as to reduce, inhibit, or prevent the flow of fluid.
• substantially all of an interior area of a cross section of a vessel is occupied when at least 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, 99.5%, 99.9%, or 100% of the interior area of the cross section of a vessel is occupied.
• the expandable cuff may also be referred to herein as a“radially expandable cuff.”
• the expandable cuff as described herein may exert a radially-outward force on the interior of a vessel, the expandable cuff may also be referred to as an“expandable anchor.”
• the expandable cuff or expandable anchor may reduce, inhibit or prevent the flow of fluid (such as blood) without necessarily remaining fixed axially along the length of a vessel.
• the expandable cuff or expandable anchor as described herein is not necessarily stationary on a longitudinal axis of the vessel, even if the expandable cuff or expandable anchor is in a deployed configuration.
• the deployed expandable cuff exerts a radially-outward force on an inside surface of a vessel.
• the deployed expandable cuff helps to immobilize the endoscope inside the vessel during imaging and/or the procedure.
• the endoscope comprises an expandable distal tip as described herein, which can permit the endoscope to have a sufficiently small diameter to advance through, image, and/or perform a surgical procedure in even small vessels, such as vasculature in the extremities or the brain.
• a“vessel” refers to a body vessel, for example a blood vessel or chamber of the heart.
• an endoscope or endoscopy system as described herein is for medical use.
• the endoscope or endoscopy system in accordance with some embodiments can include an endoscope comprising, consisting essentially of, or consisting of a hub, a shaft extending from the hub and comprising a distal tip and one or more expandable cuffs (such as a radially-expandable sleeves or protrusions) that are movable between a contracted configuration and a deployed configuration.
• an endoscope comprising, consisting essentially of, or consisting of a hub, a shaft extending from the hub and comprising a distal tip and one or more expandable cuffs (such as a radially-expandable sleeves or protrusions) that are movable between a contracted configuration and a deployed configuration.
• expandable cuffs such as a radially-expandable sleeves or protrusions
• An outer surface of the expandable cuff can be disposed further away from a longitudinal axis of the shaft when the expandable cuff is in the deployed configuration than when the expandable cuff is in the contracted configuration.
• the expandable cuff in the deployed configuration and shaft can occupy all or substantially all of an interior area of a cross section of the vessel (such as a blood vessel or heart chamber), for example least 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, 99.5%, 99.9%, or 100% of the interior area of the cross section of the vessel.
• the deployed expandable cuff can thus inhibit, reduce, or prevent fluidic flow (such as blood flow) inside the vessel, thus permitting visualization of the interior of the vessel.
• the expandable cuff in the contracted configuration permits the movement of the endoscope shaft along a longitudinal axis of the vessel.
• the endoscope further comprises an illuminating element within the distal tip. The illuminating element can be disposed to illuminate the field of view of the image sensor.
• the endoscope further comprises an image sensor and an illuminating element disposed within the distal tip.
• the microendoscope inhibits, reduces, or prevents fluidic flow in the vessel (such as blood flow), thus permitting direct imaging of the interior of the vessel with the image sensor.
• the expandable cuff and endoscope inhibiting, reducing, or preventing fluidic flow though the vessel can inhibit, reduce, or eliminate fluid downstream (relative to fluid flow) of the expandable cuff, so that the interior of the vessel can be directly imaged by the image sensor at the distal tip of the endoscope without interference from the fluid.
• the expandable cuff when deployed, exerts a radial force against the interior of the vessel (such as blood vessel).
• the radial force holds the endoscope in place. It is contemplated that holding the endoscope in place can facilitate local imaging.
• the expandable cuff when deployed, immobilizes or stabilizes the endoscope relative to surrounding tissue which can further facilitate imaging by the endoscope while it is immobilized.
• the expandable cuff may hold the distal end of the endoscopy system fixed in the longitudinal direction relative to the vessel that surrounds the distal end such that the distal end does not move axially along the vessel when the expandable cuff is in the deployed configuration.
• the expandable cuff in the deployed configuration may allow the distal end of the endoscope to move along the axial direction of the vessel that surrounds the distal end.
• the expandable cuff is adapted to stabilize or immobilize the distal tip of endoscope relative to the surrounding tissue when the expandable cuff is in the deployed configuration.
• the expandable cuff can be moved into the deployed configuration to move the outer surface of the expandable cuff against a lumenal surface (which may also be referred to as an“inner” or“inside” surface) of a blood vessel or heart chamber that surrounds the endoscopy system.
• the expandable cuff when deployed, has a diameter that is within about 20% of the diameter of the vessel or heart chamber, for example within 20%, 15%, 10%, 5%, 4%, 3%, 2%, or 1% of the diameter of the blood vessel or heart chamber.
• the expandable cuff can be deployed to exert a radially-outward force on an inside surface of a vessel (such as a blood vessel or heart chamber) through which the endoscopy system is advanced.
• the expandable cuff can include features to inhibit, mitigate, or avoid damage to the surrounding tissue upon which the expandable cuff is deployed.
• the endoscope can be arranged to inhibit, mitigate, or avoid damage to the surrounding tissue when the expandable cuff is deployed.
• the endoscope can further comprise an image sensor within the distal tip.
• endoscopy systems are described.
• the endoscopy system can comprise, consist essentially of, or consist of an endoscope as described herein. It is understood herein that when the term“endoscope” or“microendoscope” is mentioned herein (including variations of this root term), an endoscopy system comprising, consisting essentially of, or consisting of the endoscope is also expressly contemplated. Additionally, it is understood that when“endoscopy systems” (including variation of this root term) are mentioned herein, endoscopy systems comprising, consisting of, or consisting essentially of an endoscope such as a microendoscope are expressly contemplated.
• Endoscopy systems comprising, consisting essentially of, or consisting of only a single endoscope are expressly contemplated, but unless expressly stated, endoscopy systems are described herein are not necessarily limited to only a single endoscope.
• the endoscopy system further comprises a guidewire.
• the endoscopy system further comprises an illumination source, such as a laser.
• the illumination source can be in optical communication with the illumination element as described herein, or can be adapted to be placed in optical communication with the illumination element as described herein.
• the endoscopy system further comprises an inflation pump.
• the inflation pump can be in fluid communication, or can be adapted to be place in fluid communication with an internal space of the expandable cuff
• a suitable scale of endoscope and expandable cuff can be selected such that the deployed expandable cuff and shaft can occupy all or substantially all of an interior area of a cross section of the blood vessel.
• a larger diameter of endoscope shaft and deployed expandable cuff may be suitable for the endoscope to occupy all or substantially all of an interior area of a cross section of the vessel.
• an “endoscope” as described herein is not necessarily limited to endoscopes less than 1 cm in diameter.
• endoscopes such as microendoscopes
• endoscopy systems and methods herein.
• the endoscope exerts a radially- outward force on the vessel.
• the endoscope can include a working channel that is sized to allow a tool to be inserted into the working channel.
• the working channel can be configured to allow a tool inserted into the working channel to be advanced along the working channel to reach a distal end of the endoscope.
• the working channel can have an opening at a distal end of the working channel, thereby allowing a distal portion of the tool to exit the distal end of the endoscope.
• a distal portion of the working channel can be distensible and a longitudinally overlapping portion of an outer sheath of the shaft can also be deformable, allowing the profile of the endoscope to expand as a tool within the working channel moves distally past an element (e.g., image sensor) within the lumen of the endoscope.
• the endoscope comprises a tool, but without a working channel.
• the tool can be advanced longitudinally along the shaft and past the image sensor to the distal end of the endoscope without passing through a working channel.
• the expandable cuff includes a pliable portion and a reinforced portion.
• the pliable portion can be more distensible than the reinforced section.
• the expandable cuff can be adapted so that the reinforced section contacts and presses against a surrounding tissue when the expandable cuff is deployed.
• the pliable portion can be arranged so that it does not contact the surrounding tissue when the expandable cuff is deployed.
• the pliable portion can further distend to accommodate increased contact pressure between the reinforced portion and the surrounding tissue such that the contact area between the reinforced portion and the surrounding tissue is stabilized, for example to avoid or inhibit puncturing, tearing, or abrasion of the surrounding tissue.
• the pliable portion distends to accommodate increased contact pressure thereby maintaining a stable contact area of the reinforced portion with the inner surface of the vessel and mitigating or avoiding the reinforced portion from pressing against and damaging additional areas of the endothelium of the vessel.
• the contact area of the reinforced portion with the inner surface of the vessel wall can remain relatively unchanged in response to pressure fluctuations on the expandable cuff, and thus can avoid or mitigate damage to the endothelium of the vessel.
• Stabilizing the contact area between the expandable cuff and the surrounding tissue can reduce or avoid damage to the surrounding tissue when the expandable cuff is deployed (to immobilize or stabilize the endoscopes relative to the surrounding tissue).
• expandable cuffs of endoscopes of some embodiments herein are configured to immobilize and/or stabilize the shaft of an endoscope at a position within a vessel.
• the endoscopes and endoscopy systems can include features configured for one or more medical procedures such as angioplasty, electrocauterization, cryotherapy, neuroablation, clot removal, device implantation.
• the endoscope is not configured for angioplasty.
• the expandable cuff does not comprise, consist essentially of, or consist of an angioplasty balloon.
• the expandable cuff of some embodiments can be configured to immobilize the endoscope in the vessel.
• the expandable cuff can be arranged to stabilize or immobilize the illuminating element and image sensor while imaging is performed within a vessel, and/or as a tool moves through the working channel and longitudinally past the image sensor.
• expandable cuffs of endoscopes of some embodiments herein by stabilizing vascular tissue when in the deployed state, can have minimal impact on this tissue, and thus are configured to have a minimal or no physiological impact on the tissue once they have finished being deployed.
• the expandable cuff does not induce any appreciable physiological change to the vessel or heart chamber.
• the endoscopy system is configured for percutaneous access to the vessel.
• FIGURE 1 depicts a generalized endoscope 100 in accordance with some embodiments.
• the endoscope 100 can include a hub 110, which remains outside the patient's body.
• the hub 110 can be used by the operator to manipulate the endoscope 100, as described more fully below.
• An elongated, flexible shaft 120 can extend from that hub 110.
• the shaft 120 can be inserted into the patient's body.
• the shaft 120 can connect the hub 1 10 to a distal tip 130 of the endoscope 100.
• the shaft 120 can have an opening 132 at the distal tip 130 of the endoscope 100.
• the shaft 120 can be hollow or include one or more lumens.
• the opening 132 can provide a path for the interior space of the shaft 120 (or the interior space of a lumen within the shaft) to communicate with the outside environment.
• the opening 132 can allow the interior space of the shaft 120 to communicate with an internal cavity of a patient when the shaft 120 is inserted through an incision in the skin of the patient.
• the opening 132 can allow the interior space of the shaft 120 to communicate with an internal space of a vessel (e.g., blood vessel) or a heart chamber of a patient when the shaft 120 is inserted endovascularly in the patient, for example for direct imaging of the interior of the vessel or heart chamber with an image sensor in the distal tip as described herein ⁇ See, e.g., the distal tip 130 and image sensor 140 of FIGURE 2).
• the hub 110 can include one or more ports 1 12. As described in more detail below, an item (e.g., tool, flushing fluid) can be inserted into a proximal opening 114 of the port 112, advanced along the interior of the shaft 120, and passed through the opening 132 at the distal end 130 of the shaft 120.
• the hub 110 can be adapted to receive a guidewire 10.
• the endoscope 100 is mounted onto a guidewire 10 in an over-the-wire configuration.
• the endoscope 100 can be mounted onto a guidewire 10 in a rapid exchange configuration.
• the endoscope 100 in the contracted state is configured to ride along a guidewire 10 through a blood vessel.
• the endoscope 100 can include a guidewire lumen that is sized to receive a guidewire 10, as shown in FIGURE 1.
• the endoscope 100 can be configured to enter the deployed configuration while the guidewire 10 is disposed in the guidewire lumen.
• a proximal end of the guidewire lumen can be disposed on the hub 110.
• the endoscope 100 can include data communication lines 12 and/or power lines 14.
• the hub 110 can be configured to allow data communication lines 12 and/or power lines 14 to extend out of the hub 110.
• the data communication line 12 can transmit data (e.g., image sensor data) to an electronic device (e.g., display screen).
• the power line 14 can provide power to electronics housed within the hub 112 or at another location of the endoscope 100.
• the shaft 120 can include an expandable cuff 180 such as an radially- expandable sleeve as described herein.
• the expandable cuff 180 can be movable between a contracted configuration and a deployed configuration. A distance of an outer periphery of the expandable cuff 180 from a longitudinal axis of the shaft 120 can be greater when the expandable cuff 180 is in the deployed configuration compared to when the expandable cuff 180 is in the contracted configuration.
• the expandable cuff 180 can be moved from the contracted configuration to the deployed configuration by inflating an internal space of the expandable cuff 180.
• the endoscope 100 can have an inflation channel 13 that extends from the hub 110 to an internal space of the expandable cuff 180, as depicted in FIGURE 1.
• a fluid e.g., saline
• gas can be passed through the inflation channel 13 from the hub 1 10 to the internal space of the expandable cuff 180 to fill the internal space of the expandable cuff 180.
• the expandable cuff 180 can be moved from the contracted configuration to the deployed configuration by adding or pressurizing fluid within an internal space of the expandable cuff 180.
• the expandable cuff 180 can be moved from the deployed configuration to the contracted configuration by removing or depressurizing fluid within an internal space of the expandable cuff 180.
• the endoscope When the expandable cuff is deployed, the endoscope can occupy all or substantially all of an interior area of a cross section of a specified vessel. In some embodiments, when the expandable cuff is deployed, the endoscope can thus inhibit, reduce, or stop fluidic flow (such as blood flow) inside the vessel, thus permitting visualization of the interior of the vessel and/or surgical procedures in the vessel
• the endoscope 100 has one flow channel 13 that is fluidic ally connected to one expandable cuff 180.
• the flow channel 13 can be for inflation of the expandable cuff 180.
• the endoscope 100 can include one or more than one expandable cuffs 180 and one or more than one flow channels 13.
• the one or more expandable cuffs 180 can be fluidically connected to the one or more flow channels 13
• a flow channel 13 can be fluidically connected to one or more than one expandable cuffs 180.
• An expandable cuff 180 can be fluidically connected to one or more than one flow channels 13.
• the shaft 120 can include an expandable portion 122.
• the expandable portion 122 can be adapted to reversibly expand.
• the expandable portion 122 can be configured to expand radially to allow items that have a large profile to push di stall y past other components of the endoscope 100 that are located at the expandable portion 122 of the shaft 120.
• the expandable portion 122 can surround a camera lens that occupies a large size profile.
• the expandable portion 122 can expand to allow tools to navigate distally past the camera lens.
• the shaft 120 can include a rigid portion 124.
• the rigid portion 124 can be adapted so that it does not reversibly expand.
• the rigid portion 124 can be longitudinally aligned with portions of the shaft 120 that need not expand to allow' a large profile item to advance distally toward the opening 132.
• the rigid portion 124 can surround fiber optic fibers, electrical cords, or other low-profile items that do not require the shaft 120 to radially expand to allow a tool to advance past these low-profile items.
• the expandable cuff 180 can be arranged to be entirely within the expandable portion 122. In some arrangements, the expandable cuff 180 can be disposed entirely within the rigid portion 124. In some embodiments, the expandable cuff 180 can be disposed on the shaft 120 (integrally or in a separate piece) such that a first portion of the expandable cuff 180 is disposed on the expandable portion 122 and a second portion of the expandable cuff 180 is disposed on the rigid portion 124, as shown in FIGURE 1.
• the distal portion of the shaft 120 that is inserted into the patient can have an outer diameter of about 2 mm.
• the outer diameter of the shaft is about: 0.5 mm, 0.6 mm, 0.8 mm, 1.0 mm, 1.5 mm, 2.0 mm, 3.0 mm, 4.0 mm, or 5.0 mm, including ranges between any two of the listed values.
• the outer diameter of the shaft 120 is between the range of 0.5 mm to 5.0 mm, 1 .0 m to 4.0 mm, 2.0 mm to 3.0 mm, or 1 5 mm to 2.5 mm.
• the outer of the diameter of the shaft is larger, for example, up to about 10 mm, 20 mm, 50 mm, 100 mm, 200 mm, 500 mm, 1000 mm, 1500 mm, or 2000 mm, including ranges between any two of the listed values, for example 10— 2000 mm, 10— 1000 mm, 10 - 500 mm, 100 - 2000 mm, 100 - 1000 mm, or 100 - 500 mm.
• FIGURE 2 A shows an end view of a non-limiting, illustrative embodiment of a distal tip 130 of the endoscope 100.
• the expandable portion 122 of the shaft 120 can surround an image sensor 140.
• the expandable cuff 180 can be disposed on an outer surface of the shaft 120.
• One more working channels 150 can be disposed within the lumen of the shaft 120.
• the working channels 150 can be sized to allow an item such as a tool to be passed through the working channel 150 to reach the distal tip 130 of the endoscope 100.
• the distal tip 130 includes two working channels 150 that are disposed radially outward of the image sensor 140. In some embodiments, the distal tip 130 includes only one working channel 150.
• the endoscope 100 includes three or more working channels 150.
• the working channel 150 can include a distensible portion that can reversibly deform to allow the cross-sectional area of the lumen of the working channel 150 to increase.
• the working channel 150 can allow one or more tools to be deployed from the endoscope 100 to perform a medical procedure such as imaging, biopsy, angioplasty, electrocauterization, cryotherapy, neuroablation, clot removal, aneurism reinforcement, device implantation.
• the endoscope 100 can include a guidewire lumen.
• the working channel 150 includes the guidewire lumen.
• the guidewire lumen is a lumen that is separate and distinct (e.g., spaced apart) from the working channel 150.
• the distal tip 130 can include illumination fibers 160.
• the distal tip 130 includes three illumination fibers 160.
• the distal tip 130 includes only one illumination fiber 160.
• the endoscope 100 includes two, three, or more than three illumination fibers 160.
• the illumination fibers 160 can be in optical communication with a laser light source.
• the endoscope 100 can include only one illumination fiber 160 and that single illumination fiber 160 is coupled to a laser light source, thereby allowing the single illumination fiber 160 to provide enough light to adequate illuminate the tissue space for imaging with the image sensor 140.
• FIGURE 2B shows a cross-sectional side view of another embodiment of a distal tip 130.
• the expandable cuff 180 can be fluidic ally connected to an inflation channel 13.
• the expandable cuff 180 can move from a contracted configuration (illustrated in FIGURE 2B as solid line) to a deployed configuration (illustrated in FIGURE 2B as dashed line). W'hen the expandable cuff 180 is in the deployed configuration, the endoscope 100 can occupy all or substantially all of an interior area of a cross section of a surrounding tissue such as a vessel 16.
• the expandable cuff 180 when the expandable cuff 180 is in the deployed configuration, fluidic flow (e.g., blood flow) in the vessel 16 is inhibited, reduced, or prevented, thus permitting visualization of the interior of the vessel and/or surgical procedures in the vessel.
• the microendoscope occupies at least 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, 99.5%, 99.9%, or 100% of the interior area of the cross section of the vessel.
• the expandable cuff 180 compresses the surrounding tissue 16 when the expandable cuff 180 is in the deployed configuration.
• the expandable cuff 180 can stabilize or immobilize at least a portion of the endoscope 100 relative to the surrounding tissue 16 when the expandable cuff 180 is in the deployed configuration. In some arrangements, the expandable cuff 180 is adapted to stabilize or immobilize the distal tip 130 relative to the surrounding tissue 16 when the expandable cuff 180 is in the deployed configuration. In some embodiments, the expandable cuff 180 is adapted to hold the distal tip 130 fixed in the longitudinal direction relative to the surrounding tissue when the expandable cuff 180 is in the deployed (e.g., radially- expanded) configuration. In some embodiments, the expandable cuff 180 allows the distal tip 130 to move in the axial direction of the surrounding vessel when the expandable cuff 180 is in the deployed (e.g., radially-expanded) configuration.
• the expandable cuff 180 can have an outer diameter in the deployed configuration that is slightly larger than an internal diameter of a surrounding blood vessel such that the expandable cuff 180 can exert a radially-outward force on the inside surface of the surrounding blood vessel.
• the expandable cuff 180 can be sized to exert a radially-outward force on a vessel selected from the group consisting of a pulmonary artery, a pulmonary vein, a peripheral artery, a peripheral vein, a radial artery, an inferior vena cava, a superior vena cava, an iliac vein, an iliac artery, a femoral vein, a femoral artery, an aorta, a carotid artery, a coronary artery, or two or more of the listed vessels.
• the expandable cuff 180 can be sized so that in the deployed configuration the outer surface of the expandable cuff 180 is disposed away from a longitudinal axis of the endoscope 100 by a deployed radius.
• the endoscope 100 can have a deployed radius of: 0.5 mm 1.0 mm 1.5 mm, 2.0 mm, 3.0 mm, 5.0 mm, 10 mm, and other values between the listed values.
• the endoscope 100 has a deployed radius that is within ⁇ 20%, ⁇ 15%, ⁇ 10%, ⁇ 5%, ⁇ 4%, ⁇ 3%, ⁇ 2%, or ⁇ 1% of the radius of a specified vessel or section thereof in which the endoscope is to be immobilized.
• the endoscope 100 has a deployed radius that is configured to inhibit, reduce, or stop fluid flow (such as blood flow) in the specified vessel (such as a blood vessel).
• the distal tip 130 can include a ramp 170 that is adapted to guide the working channel 150 around the image sensor 140
• the ramp 170 can be arranged so that an item (e.g., tool) that is advanced within the working channel 150 past the image sensor 140 does not impact or alter the orientation of the image sensor 140.
• the ramp 170 can protect the image sensor 140 from being knocked out of proper alignment when an item within the working channel 150 advances past the image sensor 140.
• the distal tip 130 has only one working channel 150.
• the endoscope 100 can include additional working channels 150 and ramps 170 that protect the sensor 140 from being knocked out of alignment.
• the ramp 170 can be anchored to the rigid portion 124 of the shaft 120.
• the ramp 170 can include a pin 172 that is connected to the rigid portion 124 by a strut (not shown).
• the working channel 150 can include a distensible portion 152 that longitudinally aligns with the expandable portion 122 of the shaft 120.
• the ramp 170 directs the item away from the image sensor 140, thereby protecting the alignment of the image sensor 140.
• tire distensible portion 152 of the working channel 150 radially expands to allow' the item to pass by the image sensor 140 without disrupting the position of the image sensor 140.
• the radial expansion of the distensible portion 152 of the working channel 150 can cause the expandable portion 122 of the shaft 120 to radially expand to accommodate the profile of the item passing by the image sensor 140.
• the expandable cuff 180 can longitudinally overlap with at least a portion of the expandable portion 122. In some arrangements, the expandable cuff 180 can longitudinally overlap with at least a portion of the distensible portion 152 of the working channel 150. As discussed herein, when the expandable cuff 180 is in the deployed position, all or substantially all of an interior area of a cross section of the surrounding tissue such as a vessel 16 can be occupied, thus inhibiting, reducing, or preventing fluidic flow (such as blood flow) inside the vessel 16. In some embodiments, the expandable cuff 180 can be arranged to maintain positioning of the endoscope 100 with respect to the surrounding tissue such as a vessel 16 as an item (e.g.
• the expandable cuff 180 can minimize or reduce damage to the surrounding tissue such as the vessel 16 as the item passes by the image sensor 140 to exit the distal tip 130.
• the expandable cuff 180 can be arranged to maintain positioning of the endoscope 100 with respect to the surrounding tissue such as a vessel 16 while the image sensor 140 performs local imaging.
• endoscopes comprises, consists essentially of, or consists of an endoscope or microendoscope as described in PCX Pub. No. WO 2017/027299 and/or US Pub. No. 2017/0035277.
• the endoscope can further comprise an expandable cuff as described herein.
• FIGURES 3A-3D illustrate side views of different arrangements in which the expandable cuff 180 can be used with the endoscope 100.
• the endoscope 100 can include only one expandable cuff 180 or can include more than one expandable cuff 180.
• the more than one expandable cuff 180 can be similar to one another in the deployed configuration, in the contracted configuration, or in both the deployed configuration and the contracted configuration.
• the expandable cuff 180 can comprise two spaced-apart expandable cuffs 180 that are disposed entirely within the rigid portion 124 and circumferentially surround a longitudinal axis 5 of the endoscope 100 of some embodiments. As shown in FIGURE 3 A, each of the two expandable cuffs 180 can be similar in shape to one another in the deployed configuration. As shown in FIGURE 3B, the expandable cuffs 180 can be disposed entirely upon (integrally or in a separate piece from) the expandable portion 122 of the endoscope 100.
• the endoscope 100 can include an expandable cuff 180 that is disposed entirely upon (integrally or in a separate piece from) the rigid portion 124 (or the expandable portion 122) and an expandable cuff 180 that spans portions of both the expandable portion 122 and the rigid portion 122.
• FIGURE 3D shows the endoscope 100 can include a first expandable cuff l80a that has a greater radial expansion in the deployed configuration compared to a second expandable cuff l80b.
• the endoscope 100 can include expandable cuffs 180 that are combinations of the different embodiments shown in FIGURES 3A-3D.
• FIGURES 4A-4E illustrate end views of the shaft 120 illustrating arrangements of the expandable cuff 180 that can be used with the endoscope 100 of some embodiments.
• the expandable cuff 180 can entirely circumferentially surround a longitudinal axis 5 of the endoscope 100.
• the expandable cuff 180 can only partially circumferentially surround the longitudinal axis 5.
• the endoscope 100 can include a pair of the expandable cuffs 180 that are circumferentially disposed around the shaft 120 and are similar in shape to one another.
• FIGURE 4C illustrates the endoscope 100 can have circumferentially expandable cuffs 180 that are different in shape compared to one another.
• the expandable cuffs 180 can differ in shape relative to one another with regard to the extent the expandable cuff 180 circumferentially surrounds the longitudinal axis.
• the expandable cuffs 180 can differ in shape relative to one another with regard to the extent the expandable cuffs 180 extend away from the longitudinal axis 5.
• the expandable cuffs 180 can differ in shape to one another in the deployed configuration, in the contracted configuration, or both the deployed configuration and the contracted configuration.
• FIGURE 4D illustrates that the endoscope 100 can include more than one expandable cuffs 180 that are equally distributed circumferentially about the shaft 120.
• FIGURE 4E illustrates that the endoscope 100 can include expandable cuffs 180 having combinations of the features disclosed herein.
• the expandable cuffs 180 are circumferentially disposed and around the shaft 120, and are equally distributed. In some embodiments, the expandable cuffs 180 are circumferentially disposed around the shaft 120, and unequally distributed around the shaft 120.
• FIGURE 5 illustrates a partial side view of a distal tip 130 having a tool 300 that extends distally beyond the image sensor 140 of the endoscope 100.
• the tool 300 is adapted to deploy a heart valve.
• the tool 300 is adapted to perform an ablation procedure.
• the tool 300 is adapted to perform an arthroplasty procedure.
• the endoscope 100 has only one expandable cuff 180 and that expandable cuff 180 longitudinally overlaps with a portion of the expandable portion 122 and the rigid portion 124 of the shaft 120.
• the expandable cuff 180 can be arranged in a configuration different from that shown in FIGURE 5 or may be accompanied with one or more additional expandable cuffs 180, as discussed herein.
• FIGURE 6 illustrates a partial side view of the distal tip 130 with a tool 300 being advanced distally within the working channel 150 toward the opening 132.
• the endoscope 100 includes an expandable cuff 180 that longitudinally overlaps a portion of the expandable portion 122.
• the expandable cuff 180 is shown in the deployed configuration.
• An outer surface 181 of the expandable cuff 180 is in contact with the surrounding tissue 16.
• the expandable cuff 180 can include a surface texture 182 such as pebbling, knurling, or other similar surface textures to enhance the interaction between the expandable cuff 180 and the surrounding tissue 16.
• the surface texture 182 can be adapted to increase the frictional forces between the expandable cuff 180 and the surrounding tissue 16.
• the surface texture 182 can be adapted to promote an atraumatic interaction between the expandable cuff 180 and the surrounding tissue 16 such that the damage to the surrounding tissue 16 is inhibited, mitigated, or minimized as the expandable cuff 180 presses against the surrounding tissue 16 to stabilize or immobilize the endoscope 100.
• FIGURE 6 shows that the expandable cuff 180 can include a reinforced portion 183 that is less distensible compared to a pliable portion 185.
• the reinforced portion 183 can formed by including, imbedding, or overlaying material in the reinforced portion 183.
• the included reinforcement material can be stiffer than the material of the pliable portion 185.
• the expandable cuff 180 can be arranged such that the compliance or distensibility of the reinforced portion 183 and the pliable portion 185 match one another until a threshold expansion ratio has been reached.
• An expansion ratio can be defined as the ratio between the outer dimension of the expandable cuff 180 in the deployed state compared to the outer dimension of the expandable cuff 180 in the contracted state.
• the expandable cuff 180 can be arranged such that the compliance or distensibility of the reinforced portion 183 is reduced compared to that of the pliable region 185 when the expansion ratio of the expandable cuff 180 exceeds the threshold expansion ratio.
• the expandable cuff 180 can be arranged so that as the tool 300 passes by the image sensor 140, the expandable portion 122 of the shaft expands radially outward and toward the surrounding tissue 16 (as indicated by the vertical double-headed open arrow).
• the expandable cuff 180 can be arranged so that as the expandable portion 122 moves away from the image sensor 140 and toward the surrounding tissue 16, the pliable portion 185 expands longitudinally (as indicated by the horizontal double-headed open arrow) to accommodate the inflation fluid (or gas) within the expandable cuff 180 that is displaced by the movement of the expandable portion 122 away from the image sensor 140 and toward the surrounding tissue 16.
• the expansion of the pliable region 185 in the longitudinal direction can allow the contact area between the expandable cuff 180 and the surrounding tissue 16 to remain substantially unchanged as the tool 300 moves distally past the image sensor 140.
• FIGURE 6 illustrates an expandable cuff 180 that spans the interface of the expandable portion 122 and the rigid portion 124 of the shaft 120
• the expandable cuff 180 can be disposed entirely upon (integrally or as a separate part) the rigid portion 124 or entirely within the expandable portion 122.
• the endoscope 100 can include an expandable cuff 180 that is disposed entirely upon (integrally or as a separate part) the rigid portion 124 and includes the reinforced and pliable portions 183, 185.
• the pliable portion 185 can distend to maintain a substantially unchanged footprint between the expandable cuff 180 and the surrounding tissue such as a vessel 16 as the compressive force between the expandable cuff 180 and the surrounding tissue such as a vessel 16 varies (such as due to a contraction of the surrounding tissue or applying a torque to the endoscope 100).
• FIGURE 6 illustrates that expandable cuff 180 can include a pliable portion 185 that expands longitudinally along rigid portion 124 and longitudinally along the expandable portion 122.
• the expandable cuff 180 can include more than one pliable portion 185.
• the expandable cuff 180 can have a first pliable portion 185 that expands longitudinally along the rigid portion 124 and a second pliable portion 185 that expands longitudinally along the expandable portion 122.
• the endoscope or endoscopy system comprises an expandable cuff such as a radially-expandable protrusion or sleeve as described herein.
• the expandable cuff in the deployed condition and shaft (and thus the endoscope) occupy all or substantially all of an interior area of a cross section of the vessel, so as to inhibit, reduce, or prevent fluidic flow (such as blood flow) inside the vessel.
• the expandable cuff is deployed by introducing fluid or gas into an internal space of the expandable cuff.
• the expandable cuff can be deployed by other methods such as heating or unsheathing a shape memory material.
• the expandable cuff is adapted to immobilize or stabilize a portion of the endoscope as a medical procedure is performed on a tissue of a patient by tools extending through the endoscope and distally past the opening of the distal tip.
• the expandable cuff can be sized to brace the endoscope against an inside surface of a blood vessel or heart chamber.
• a method of imaging an interior of a vessel includes advancing an endoscope as described herein within a vessel to a target location.
• the method can further include expanding the expandable cuff of the endoscope to the deployed configuration, so the expandable cuff and shaft occupy all or substantially all of an interior area of a cross section of the vessel.
• the microendoscope with the expandable cuff in the deployed configuration can thus inhibit, reduce, or prevent fluidic flow (such as blood flow) inside the vessel, thus permitting visualization of the interior of the vessel and/or surgical procedures in the vessel (e.g., without interference from the fluid).
• the method further comprises imaging a field of view in the interior of the vessel while the fluid (e.g., blood) flow is inhibited, reduced, or prevented.
• the method can further comprise contracting the expandable cuff.
• the method further comprises resuming moving the expandable endoscope toward the target location along the guidewire after the field of view has been imaged.
• an outer surface of the expandable cuff contacts two or more portions of an inner surface of the vessel, in which the portions are circumferentially disposed around the endoscope.
• advancing the endoscope includes moving the endoscope along a guidewire toward the target location.
• the method further includes halting the endoscope along the guidewire, expanding the expandable cuff such that the expanded expandable cuff inhibits, reduces, or prevents fluid (e.g., blood) flow in the vessel.
• the vessel in which the method is performed is a blood vessel, for example a radial artery or a femoral artery.
• the method is performed in a coronary artery and the target location includes a portion of the coronary artery that includes an obstruction.
• the vessel in which the method is performed is a chamber of the heart. Wherever a method of imaging comprising an endoscope is described herein, also contemplated is an endoscope for use in imaging.
• the endoscope is loaded onto a guidewire after the guidewire has been placed in the patient.
• a guidewire can be advanced endovascularly until a distal end of the guidewire is at or near the target location (by way of example, the guidewire can be positioned using fluoroscopy).
• the distal end of the guidewire can remain in place at or near the target location while a proximal end of the guidewire is fed through the distal end of the endoscope and advanced proximally through the endoscope until the proximal end of the guidewire emerges from a proximal end of the endoscope.
• the endoscope can then be advanced along the guidewire to bring the distal end of the endoscope to the target location.
• the guidewire can be fed through the distal end of the endoscope before introducing the guidewire into a vessel of the patient.
• the endoscope can be loaded onto the guidewire first and then the guidewire can be placed within the patient while the endoscope is loaded onto the guidewire.
• An endoscopy system for performing a heart-valve-repair procedure includes a shaft comprising a deformable outer sheath that circumferentially surrounds an image sensor, an illuminating element.
• An expandable cuff is coupled to the shaft of the endoscope. The expandable cuff is moveable from a contracted configuration to a deployed configuration. The expandable cuff can be sized to press against the inner surface of a blood vessel or heart chamber when the expandable cuff is in the deployed configuration.
• FIGURE 7 illustrates a method of using the endoscope 100 to perform a medical procedure.
• the distal tip 130 of the endoscope 100 is advanced anterograde along the superior vena cava 17 and into the right atrium 18 of a heart 19.
• a heart-valve-leaflet capture device 310 e.g., a clip
• the illustrated endoscope 100 has an expandable cuff 180 sized to press against the inner surface of the superior vena cava 17 when the expandable cuff 180 is in the deployed configuration.
• the expandable cuff 180 can stabilize or immobilize the position of the distal tip 130.
• the expandable cuff 180 can be moved into the deployed configuration to stabilize or immobilize the distal tip 130 while the heart-valve-leaflet device 310 is deployed from the distal tip 130.
• the medical procedure comprises advancing the endoscope 100 through the aorta or via a puncture of the heart apex instead of the superior vena cava 17.
• An endoscopy system for performing a medical imaging procedure includes a hollow shaft comprising an expandable cuff disposed on an outer surface of the shaft, an image sensor and an illuminating element being disposed within the hollow shaft.
• the expandable cuff is moveable from a contracted configuration to a deployed configuration.
• the expandable cuff can be sized to occupy all or substantially all of an interior area of a cross section of the a blood vessel or other tube-like organ (e.g., intestine) when the expandable cuff is in the deployed configuration, thus inhibiting, reducing, or preventing fluid flow in the organ.
• FIGURES 8A and 8B illustrate a method of using the endoscope 100 to perform a medical imaging procedure.
• the distal tip 130 of the endoscope 100 is advanced along a vessel 4 (e.g., blood vessel) toward a target location 6.
• the target location 6 can be a region of surrounding tissue that is desired to be imaged.
• the distal tip 130 can have an opening that allows an image sensor within the endoscope 100 to image the field of view 8 as discussed herein.
• the expandable cuff 180 can be in the contracted configuration as the endoscope 100 is advanced toward the target location 6 to bring the target location 6 within the field of view 8 of the endoscope.
• FIGURE 8B illustrates that once the endoscope 100 is properly positioned to view the target location 6, the expandable cuff 180 can be moved into the deployed configuration occupy substantially all of an interior area of a cross section the vessel 4 as discussed herein.
• the expandable cuff 180 in combination with the shaft 120
• the expandable cuff 180 can inhibit, reduce, or prevent the flow of fluid in the vessel (e.g., blood in a blood vessel).
• the inhibition, reduction, or prevention of fluid downstream of the expandable cuff can permit imaging direct imaging of inside the vessel by the image sensor 140 in the distal tip 130 of the endoscope.
• the expandable cuff 180 can be moved to the contracted configuration, as discussed herein, and the endoscope 100 can be withdrawn from the vessel 4.
• a range includes each individual member.
• a group having 1-3 cells refers to groups having 1, 2, or 3 cells.
• a group having 1-5 cells refers to groups having 1, 2, 3, 4, or 5 cells, and so forth.
• An microendoscope comprising a hub
• a shaft extending from the hub and comprising a distal tip
• an image sensor within the distal tip the image sensor having a field of view external from the microendoscope
• an illuminating element within the distal tip configured to emit light within the field of view of the image sensor
• an expandable cuff disposed on at least a portion of the shaft, the expandable cuff being movable between a contracted configuration and a deployed configuration, an outer surface of the expandable cuff being disposed further away from a longitudinal axis of the shaft when the expandable cuff is in the deployed configuration than when the expandable cuff is in the contracted configuration.
• microendoscope of Embodiment 1 wherein the microendoscope is configured for use in a specified vessel, and wherein the expandable cuff, when expanded, has an outer diameter that is about the same as an inner diameter of the specified vessel.
• microendoscope of any one of Embodiments 2-3 wherein the specified vessel is selected from the group consisting of: a femoral artery, a radial artery, a pulmonary vein, a coronary artery, an aorta, and a carotid artery.
• the expandable cuff further comprises a internal space in fluid communication with an inflation port disposed on the hub.
• microendoscope of any one of the preceding Embodiments further comprising: a working channel disposed within the shaft and extending from the hub to the distal tip, at least a portion of the working channel being disposed between the longitudinal axis of the shaft and an overlying portion of the expandable cuff.
• microendoscope of any one of the preceding Embodiments wherein the internal space of the expandable cuff comprises a plurality of inflation channels, each of the plurality of inflation channels being fluidically isolated from one another.
• microendoscope of any one of Embodiments 1-11 further comprising a mitral clip, wherein the specified vessel is selected from the group consisting of: the inferior vena cava and the aorta.
• microendoscope of any one of the preceding Embodiments wherein the expandable cuff is configured for percutaneous access to the specified vessel.
• microendoscope of Embodiment 1 wherein the microendoscope in the contracted configuration is configured to ride along a guidewire through a blood vessel
• microendoscope of Embodiment 1 or 16 wherein the microendoscope further comprises a guidewire lumen sized to receive a guidewire.
• microendoscope of Embodiment 17 further comprising a working channel disposed within the shaft and extending from the hub to the distal tip, at least a portion of the working channel being disposed between the longitudinal axis of the shaft and an overlying portion of the expandable cuff, the working channel comprising the guidewire lumen.
• the microendoscope is configured to enter the deployed configuration while the guidewire is disposed in the guidewire lumen.
• microendoscope any one of Embodiments 17-19, wherein a proximal end of the guidewire lumen is disposed on the hub.
• a method of using an expandable microendoscope comprising: advancing the expandable microendoscope within a vessel to a target location; and
• Embodiment 28 wherein deploying the instrument comprises distending an inner surface of the expandable cuff with an outer surface of the working channel.
• Embodiment 31 The method of Embodiment 30, wherein the vessel is selected from the group consisting of the inferior vena cava and the aorta.
• Embodiment 32 The method of Embodiment 30, wherein the target location comprises the heart, and wherein the vessel is the inferior vena cava, the method further comprising visualizing tissue of the heart while the expandable cuff is expanded in the inferior vena cava, wherein the mitral clip is applied to the heart after the visualizing.
• Embodiment 37 The method of Embodiment 36, wherein the vessel is the radial artery or femoral artery.
• Embodiment 38 The method of Embodiment 36, wherein the vessel is the coronary artery, and the target location comprises a portion of the coronary artery comprising an obstruction
• An endoscopy system comprising: an microendoscope comprising an image sensor disposed within a distal tip of the microendoscope, an illuminating element within the distal tip, and an expandable cuff disposed on an outer surface of the microendoscope;
• an inflation pump in fluid communication with an internal space of the expandable cuff.
• Embodiment 40 The endoscopy system of Embodiment 30, wherein the microendoscope comprises, consists essentially of, or consists of the microendoscope of any one of Embodiments 1-15
• Some embodiments include a method of using an endoscope, for example an endoscope as described herein.
• the method includes advancing the expandable endoscope within a vessel to a target location, expanding an expandable cuff of the endoscope to bring an outer surface of the expandable cuff into contact with two or more portions of an inner surface of the vessel, the two or more portions being circumferentially disposed around the endoscope.
• Bringing the expandable cuff into contact with portions of the inner surface of the vessel can inhibit, reduce, or stop fluid flow in the vessel (such as blood flow in the blood vessel), thus permitting visualization of the interior of the vessel.
• the visualization can be performed by an image sensor as described herein.
• expanding the expandable cuff includes introducing a fluid into an internal space of the expandable cuff. In some embodiments, bringing the expandable cuff into contact with portions of the inner surface of the vessel maintains a position of the expandable endoscope within the vessel. In some embodiments, the method further includes deploying an instrument from a working channel of the expandable endoscope, wherein at least a portion of the working channel passes between the expandable cuff and a longitudinal axis of the expandable endoscope. In some embodiments, deploying the instrument includes distending an inner surface of the expandable cuff with an outer surface of the working channel. In some embodiments, the method includes deploying a mitral clip from the working channel.
• the method includes deploying from the working channel an instrument that is adapted to ablate a portion of a pulmonary vein. In some embodiments, the method further comprises collecting images distal to a leading end of the endoscope while the position of the endoscope is maintained.

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