Abstract: Apparatus and methods for attaching and forming enclosed inflatable members on an endoscope assembly with a disposable sheath are disclosed. In one embodiment, an apparatus includes a flexible and resilient cuff member that is positioned on the outer surface of the disposable sheath and sealably and fixedly bonded to the sheath cover material at the cuff edges to form an annular space capable of being inflated. The inflatable member formed thereby is inflated through a lumen internal to the sheath that has an opening into the interior annular space. The inflatable member may be inflated to exert a longitudinal force on the insertion tube, thereby moving the endoscope assembly along a body passage. Alternately, a sheath may include a plurality of inflatable cuffs that may be inflated to create an isolated space therebetween within the body passage.

Abstract: Apparatus and methods for obtaining biopsy samples using an endoscope assembly are disclosed. In one embodiment, an assembly adapted for use with an endoscopic insertion tube includes a sheath having a body portion adapted to at least partially encapsulate a distal portion of the insertion tube, and a biopsy sampling device attached to the sheath and including a collection member proximate an end of the body portion. The biopsy sampling device may be attached to the body portion of the sheath, or alternately, may be attached to an enclosed distal end of the sheath. The assembly may also include a cover attached to the sheath and positionable proximate the biopsy sampling device. An actuation member may be attached to the cover and may extend along the sheath, allowing the operator to actuate the cover between a covered position and a collecting position.

Abstract: Apparatus and methods for endoscope assemblies having working channels with reduced bending and stretching resistance are disclosed. In one embodiment, an endoscope assembly includes a sheath having a body portion adapted to at least partially encapsulate an endoscopic insertion tube, and a working channel attached to the body portion and extending along at least a portion of the body portion. The working channel includes a component for reducing the resistance of the assembly to bending and stretching. In alternate aspects, the working channel may include a cut, a gap, a sliding portion, or an expansion section. Endoscope assemblies having a working channel in accordance with the invention advantageously reduce the articulation and stretching resistance of the assembly during articulation of the endoscope assembly.

Abstract: A thin-walled polymeric component that may have a selected complex shape, and a method of forming the component. The method includes heating a portion of a polymeric film to a selected malleable temperature, and forming a protrusion in the heated portion while it is malleable. The protrusion defines a protrusion having a first shape. The method also includes positioning a forming tool in the protrusion's interior and drawing a partial vacuum from within the protrusion so as to exert a force on the protrusion and move the protrusion's sidewalls inwardly into engagement with the forming tool. As the partial vacuum is drawn, the protrusion moves to a second shape that may be different than the first shape and that closely conforms to the selected shape of the forming tool. The protrusion is cooled below the malleable temperature and the forming tool is then removed.

Abstract: Methods and apparatus for inhibiting longitudinal expansion of a body portion of an endoscopic sheath during inflation of an inflatable member are disclosed. In one embodiment, a sheath assembly includes a body portion adapted to encapsulate a distal end of an insertion tube, and an inflatable member coupled to the body portion and adapted to be inflated radially outwardly from the body portion. The sheath assembly further includes an expansion-inhibiting mechanism coupled to at least one of the inflatable member and the body portion. The expansion-inhibiting mechanism advantageously inhibits a longitudinal expansion of the body portion during inflation of the inflatable member. The expansion-inhibiting mechanism may assume a variety of embodiments, including, for example, a non-compliant member, a longitudinally-stretched portion, a reinforcing spring member, a pressure relief device, or a suitable detent mechanism.

Abstract: Apparatus and methods for endoscope assemblies having working channels with reduced bending and stretching resistance are disclosed. In one embodiment, an endoscope assembly includes a sheath having a body portion adapted to at least partially encapsulate an endoscopic insertion tube, and a working channel attached to the body portion and extending along at least a portion of the body portion. The working channel includes a component for reducing the resistance of the assembly to bending and stretching. In alternate aspects, the working channel may include a cut, a gap, a sliding portion, or an expansion section. Endoscope assemblies having a working channel in accordance with the invention advantageously reduce the articulation and stretching resistance of the assembly during articulation of the endoscope assembly.

Abstract: A thin-walled elastic sheath that can be stretched axially over an elongated imaging device to closely conform to the device and isolate the device from an external environment, and a method of forming such a sheath, are shown and described. The method includes the steps of heating at least a portion of a sheet of an elastomeric material to an elevated temperature to form a malleable heated portion of the sheet, pressing an elongated forming tool against the sheet at a location central with respect to the heated portion of the sheet, stretching the heated portion of the elastomeric material with the forming tool until an elastic conforming portion of the sheet is conformed to at least a portion of the length of the forming tool, and removing the forming tool from the conforming portion of the sheet to leave the thin-walled, elastic sheath having a wall thickness approximately equal to or less than 0.006 inches.

Abstract: A thin-walled elastic sheath that can be stretched axially over an elongated imaging device to closely conform to the device and isolate the device from an external environment, and a method of forming such a sheath, are shown and described. The method includes the steps of heating at least a portion of a sheet of an elastomeric material to an elevated temperature to form a malleable heated portion of the sheet, pressing an elongated forming tool against the sheet at a location central with respect to the heated portion of the sheet, stretching the heated portion of the elastomeric material with the forming tool until an elastic conforming portion of the sheet is conformed to at least a portion of the length of the forming tool, and removing the forming tool from the conforming portion of the sheet to leave the thin-walled, elastic sheath having a wall thickness approximately equal to or less than 0.006 inches.

Abstract: Apparatus and methods for attaching and forming enclosed inflatable members on an endoscope assembly with a disposable sheath are disclosed. In one embodiment, an apparatus includes a flexible and resilient cuff member that is positioned on the outer surface of the disposable sheath and sealably and fixedly bonded to the sheath cover material at the cuff edges to form an annular space capable of being inflated. The inflatable member formed thereby is inflated through a lumen internal to the sheath that has an opening into the interior annular space. In another embodiment, the annular space may be divided into separate inflatable lobes. In still another embodiment, the cuff member is a flexible and resilient member that is substantially toroidal in shape that is positioned on the outer surface of the sheath. In a further embodiment, the inflatable member is formed from an excess length of sheath cover material disposed on the disposable sheath.

Abstract: A thin-walled elastic sheath that can be stretched axially over an elongated imaging device to closely conform to the device and isolate the device from an external environment, and a method of forming such a sheath, are shown and described. The method includes the steps of heating at least a portion of a sheet of an elastomeric material to an elevated temperature to form a malleable heated portion of the sheet, pressing an elongated forming tool against the sheet at a location central with respect to the heated portion of the sheet, stretching the heated portion of the elastomeric material with the forming tool until an elastic conforming portion of the sheet is conformed to at least a portion of the length of the forming tool, and removing the forming tool from the conforming portion of the sheet to leave the thin-walled, elastic sheath having a wall thickness approximately equal to or less than 0.006 inches.

Abstract: A sheath for use with an endoscope having a flexible insertion tube to isolate at least a portion of the insertion tube from an external environment, and to alter the bending characteristics of at least a portion of the insertion tube, is shown and described. The sheath includes a compliant tube and an elongated shape-retaining member attached to the compliant tube. The compliant tube has a proximal end having an interior area configured to receive a first portion of the flexible insertion tube. The shape-retaining member extends axially along a second portion of the flexible insertion tube when the first portion of the flexible insertion tube is positioned in the interior area of the compliant tube. The shape-retaining member is sufficiently stiff to remain in a selected shape or position, and to retain the second portion of the flexible insertion tube in the selected shape or position.

Abstract: A holding tray assembly for holding an endoscopic sheath during installation of the sheath onto an insertion tube of an endoscope and removal of the sheath from the insertion tube, wherein the sheath has a distal end and an open proximal end shaped to receive the insertion tube. The holding tray assembly has a tray with a slot formed therein extending inward from the peripheral edge of the tray. The slot is adapted to receive at least a portion of the endoscopic sheath so the proximal end of the sheath is positioned above the tray and the distal end of the sheath is below the tray. A sheath holding clamp is connected to the tray adjacent to a closed end of the slot, wherein the sheath holding clamp is adapted to releasably hold at least a portion of the endoscopic sheath within the slot. A tray securing apparatus is connected to the tray and is adapted to secure the tray onto a floor stand or other tray support structure.

Abstract: A coupling cartridge and end cap for protecting an endoscope from contamination during use. The coupling cartridge provides fluid communication between a pair of external fluid conduits and respective channels formed in an endoscope insertion tube, and between a biopsy channel port projecting from the cartridge and an additional insertion tube channel. In one embodiment, fluid flow through the external fluid conduits is controlled by an external fluid control unit that is electrically controlled by respective switches mounted on the control handle of the endoscope. In another embodiment, fluid flow through the external fluid conduits is controlled by a valve mechanism in the coupling cartridge that is controlled by either an actuator on the cartridge or an actuator on the control handle that is mechanically coupled to the valve mechanism. The coupling cartridge may be removed from endoscope after an endoscopic procedure for disposal or rigorous cleaning.

Abstract: A partially elastic protective sheath surrounding the insertion tube of an endoscope. The sheath is partially inflated while being installed on the endoscope and remains partially inflated during endoscopy. The sheath has an end cap with a gasket shaped to provide a seal around the insertion tube during installation and endoscopy. The sheath is provided with a window near its distal end positioned in front of the viewing window of the endoscope. The sheath may have one or more channels extending along its length to accommodate one or more biopsy or fluid tubes of the endoscope. The sheath may be used with either end-viewing endoscopes or side-viewing endoscopes.

Abstract: A bending section of an endoscope is constructed from non-round vertebrae. The vertebrae are D-shaped, having a planar portion and an arcuate portion. A first pair of protrusions extends from a first surface of the vertebra, defining a vertical bending axis. A second pair of protrusions extends from a second surface of the vertebra, defining a horizontal bending axis. Because the vertebra is D-shaped, the second pair of protrusions are farther from the longitudinal bending axis of the bending section than the first pair of protrusions. To provide uniform, symmetrical bending of the bending section, the first pair of protrusions are shorter than the second pair of protrusions. In addition, the first pair of protrusions extends at a different angle than the second pair and thus have a different shape, so that the first and second pair of protrusions are not symmetrically shaped with respect to each other.