FIELD

This patent specification generally relates mainly to a medical device for use in tissue examinations such as in urology or endoscopic surgery. More particularly, some embodiments relate to an integrated, handheld, low-cost medical device having a single-use portion and one or more multiple-use portions.

BACKGROUND

Conventional endoscopy, or direct vision used to examine the interior of a hollow organ or cavity of the body, uses a complex lens system for transmitting the image for the distal tip of the endoscope to a viewer. The lens system is typically an objective lens plus a relay lens system in the case of rigid endoscopes or a bundle of optic fibers in the case of flexible endoscopes. In the case of both rigid and flexible conventional endoscopes, the lens or fiber optic system is relatively expensive and is intended to be re-used many times. Therefore, stringent decontamination and disinfection procedures need to be carried out after each use.

Disposable endoscopy is an emerging category of endoscopic instruments. In some cases the manufacture of endoscopes can be made inexpensive enough to be used on a single patient only. Disposable or single-use endoscopy lessens the risk of cross-contamination and hospital acquired diseases. Partially disposable endoscopy systems for hysteroscopy are discussed in U.S. Pat. No. 8,460,182, incorporated by reference herein. A hysteroscope having a disposable probe was offered by Endosee Corporation of Los Altos, Calif., and is now offered by CooperSurgical, Inc. of Trumbull, Conn., a company that acquired EndoSee Corporation.

The subject matter described or claimed in this patent specification is not limited to embodiments that solve any specific disadvantages or that operate only in environments such as those described above. Rather, the above background is only provided to illustrate one exemplary technology area where some embodiments described herein may be practiced.

SUMMARY

According to some embodiments that are particularly suitable for fields such as urology and endoscopic surgery rather than hysteroscopy, a low-cost medical instrument for examining a patients tissue comprises an elongated, single-use portion that includes: a handle near a proximal end of the elongated portion, which handle is configured and shaped for manual gripping of the instrument while the instrument is being used to examine the tissue; a shaft having a central axis, a distal end, a proximal end, a first conduit and a second conduit, both first and second conduits passing internally through the shaft towards the distal end of the shaft, the first conduit configured to be in fluid communication with a first proximal fluid port, and the second conduit continuing proximally to provide a substantially straight working channel in the second conduit parallel to the central axis from a proximal working channel port on the proximal end of the elongated single-use portion through the handle portion; a distal tip assembly mounted on the distal end of the shaft, the assembly having a distal outer edge rounded to a radius of at least one millimeter, the tip assembly including one or more distal ports in fluid communication with the first conduit, and a distal working channel port being in fluid communication with the second conduit; a light delivery system configured to illuminate the tissues being examined; an electronic imaging module positioned within the tip assembly; one or more electrical conductors running through the shaft in electrical connection with the imaging module; and an electrical connector on the handle portion in electrical connection with the one or more conductors.

The medical instrument further comprises a multiple-use electronics and display portion including a display, configured for mounting on the electrical connector of the single-use portion, which results in the display positioned off of the central axis of the shaft.

Some embodiments of the instrument further include one of the following elements or features and other embodiments further include two, or three, or more, or all of the following elements or features: (1) the light delivery system includes at least one LED positioned within the distal tip assembly; (2) the shaft is extruded from a synthetic polymer material; (3) the working channel is dimensioned to allow a surgical implement to pass from the proximal working channel port through the second conduit and through the distal working channel port so as to be used in a surgical procedure on the patient's tissue; (4) a path through which the surgical implement can pass from the proximal working channel port to the second conduit is straight; (5) a multi-use rechargeable battery module configured to be removably mounted to said handle portion of the elongated single-use portion; (6) one or more electrical conductors are positioned at least partially within the first conduit; (7) the electrical connector is longitudinally separated from the first proximal fluid port by at least five centimeters; (8) the electrical connector is positioned proximally from the first fluid port; (9) the elongated single-use portion further comprises a second proximal fluid port in fluid communication with the second conduit; (10) the distal outer edge of the distal tip assembly is rounded to a radius of at least two millimeters; (11) a central distal surface of the distal tip assembly includes an opening through which the electronic imaging module can view tissues being examined, the central distal surface being flat or rounded to a radius of at least 5 millimeters; (12) the mounting of the multiple-use electronic and display module results in the display being rotatable about an axis perpendicular to the central axis of the shaft; (13) the mounting of the multiple-use electronic and display module results in the display being non-rotatable about any axis parallel the central axis of the shaft: (14) the mounting of the multiple-use electronics and display module results in the display being rotatable about an axis parallel to the central axis of the shaft; (15) a sensing system configured to sense rotational orientation of the display relative to the electronic imaging module; (16) the multiple-use electronics and display module includes wireless communication circuitry configured to receive video signals originating from the electronic imaging module and to display video images from the imaging module to a user while not physically mounted to the handle portion; (17) the electrical conductor makes electrical contact with the electronics and display module using male-shaped metallic protrusions that mate with female-shaped metallic recesses on the electronics and display module; and/or (18) said multiple-use electronics and display module further includes a fixing mechanism configured to attach the electronics and display module to a users arm, wrist and/or hand.

This patent specification further describes a surgical procedure carried out using the an embodiment of the instrument described above, the procedure comprising: inserting the distal tip of the elongated single-use portion into a passageway of the patient; illuminating the patient's tissues using the light delivery system; electronically imaging the patient's tissues using the electronic imaging module; and viewing real-time the electronically imaged tissues on the display. Other examples of the surgical procedure include one or more or all of the following additional steps of features: (1) using a surgical implement passing through the distal working channel port to carry out a physical intervention on the patient's tissues; (2) the surgical implement is a hypodermic needle and the physical intervention includes injecting a fluid into the patient's tissues through the hypodermic needle; (3) the hypodermic needle is positioned within the working channel before the distal tip is inserted into the passageway (4) the surgical implement is positioned within the working channel prior to a sterilization and packaging procedure of the elongated single-use portion; (5) the passageway is the patient's urethra; and (6) attaching the electronics and display module to a user's arm, wrist or hand, and rotating the elongated single-use portion about an axis parallel to the central axis while maintaining the electronics and display module in an un-rotated position.

According to some embodiments, an endoscope comprises a single-use, disposable portion and a re-usable portion. The single-use, disposable portion comprises at least the following components that are fixedly assembled into a single unit enclosed in a sterile package configured for disposal after a single use on a patient; an elongated handle shaped and dimensioned to be grasped and manipulated by a user's hand, said handle having a proximal end and a distal end and further having a mounting connector with electrical connector elements, and a battery connector; an elongated cannula made of an extruded material, passing through the handle and enclosing a first lumen extending distally from a location inside the handle and a second lumen extending through and both distally and proximally from the handle; a tip made of a molded material, secured at a distal end of the cannula; an imaging assembly and an illumination assembly mounted in the tip; at least one side-facing port in the tip in fluid flow communication with the first lumen for inflow of fluid into the first lumen; a side-facing outflow port in the first lumen, spaced proximally from the tip, configured for outflow of fluid that has entered the first lumen through the side-facing inflow port in the tip and has passed through the first lumen in the proximal direction; electrical wires running through the first lumen from the electrical connector elements in the handle to the imaging and illumination assemblies in the tip; an outflow port in the tip in fluid flow communication with the second lumen; a side-facing inflow port in the second lumen, spaced in the proximal direction from the outflow port in the tip; and a surgical implement port facing in the proximal direction, at the portion of the second lumen that extends proximally from the proximal end of the handle, configured for insertion of a surgical implement in the distal direction to the tip along a straight insertion path. The re-usable portion of the endoscope in this embodiment is configured for mounting on the handle and removal from the handle by hand, and comprises at least: a mounting structure configured to mechanically mate with the handle's mounting connector and having electrical connector elements configured to mate with and establish electrical contact with the handle's electrical connectors when the re-usable portion is mounted on the handle; a rotation coupling between the handle and the re-usable portion configured for relative rotation the re-usable portion and the single-use portion about at least one axis; and a touch-sensitive display screen with associated electronic circuitry electrically coupled with said female mating elements, said screen configured to display video provided by said imaging assembly in the tip and to respond to touch to control imaging and illumination operations at the tip and display operations on the screen.

In some embodiments; the endoscope described in the preceding paragraph further includes one or more of the following elements or features: (1) the rotation coupling is configured for relative rotation of the re-usable and single-use portions about a two axes that are transverse to each other; (2) one of the two axes is transverse to the long dimension of the handle and the other is along the long dimension of the handle; (3) tactile feedback is used an indicator of relative position between the re-usable portion and the single-use portion; (4) the handle includes a depression shaped and dimensioned to receive a clip-on battery for powering the re-usable portion and the illumination assembly when a battery in inserted into said depression and makes electrical contact with said battery connector and the re-usable portion is mounted on the handle; (5) the single-use portion further includes a battery configured for disposal with the single-use portion, said battery being secured in the sterile package in electrical contact with said battery connector to power the illumination assembly and the re-usable portion when the re-usable portion is mounted on the handle; (6) the connector elements in the handle are male elements and the connector elements in the re-usable portion are female connector elements, thereby reducing chances of contamination of the connector elements in the re-usable portion; (7) the tip has a convex end with a circumferential periphery that is more curved then a central portion to thereby ease insertion of the tip in a patient's body; (8) the distal end of the tip has a convex curvature radius of from 4 to less than 7 mm radius at a central region and from 1 to less than 4 mm radius at a peripheral area; (9) said extruded cannula is made of a multi-durometer material that is more flexible at a distal than a proximal portion of the cannula to facilitate bending the cannula near the tip; (10) the single-use portion further includes a disposable needle for injecting or withdrawing substances through said second lumen in fluid flow communication therewith, and included in said sterile package; (11) the distal end of the cannula comprises a first D-shaped portion in cross-section and a second D-shaped portion in cross-section that extends to a lesser extent in the distal direction, the first D-shaped portion contains the first lumen and the second D-shaped portion contains the second lumen; and the tip comprises a cylinder open in the proximal direction to receive the two D-shaped portions of the cannula and having an internal stop plate facilitating separation between the first and second lumens; (12) the outflow port in the first lumen is spaced at least 5 cm in the distal direction from the electrical connectors in the handle to facilitate keeping the connectors free of fluid passing through the first lumen; (13) a wiper fitted over the open end of the surgical implement port and configured to resist spillage of fluid from the second lumen in the proximal direction when the endoscope is used with a surgical implement; (14) said re-usable portion further comprises a sensor responsive to relative rotation between the re-usable portion and the single-use portion, and at least one of (i) an indicator of current relative positions of the re-usable and single-use portions, and (ii) a control changing orientation of images on the display in relation to current relative positions of the re-usable and single-use portions; and (15) said re-usable portion further comprises a fixing mechanism configured to attach the touch-sensitive display screen to a user's arm; wrist and/or hand.

This patent specification further describes an endoscopic method that comprises providing a single-use, disposable portion including the following components that are fixedly assembled into a single unit enclosed in a sterile package configured for disposal after a single use on a patient: an elongated handle shaped and dimensioned to be grasped and manipulated by a user's hand, said handle having a proximal end and a distal end and further having a mounting connector with electrical connector elements, and a battery connector; an elongated cannula passing through the handle and enclosing a first lumen extending distally from a location inside the handle and a second lumen extending through and both distally and proximally from the handle; a tip secured at a distal end of the cannula; an imaging assembly and an illumination assembly mounted in the tip; at least one inflow port in the tip in fluid flow communication with the first lumen; an outflow port in the first lumen, spaced proximally from the tip, configured for outflow of fluid that has entered the first lumen through the inflow port in the tip; electrical wires running through the first lumen from the electrical connector elements in the handle to the imaging and illumination assemblies in the tip; an outflow port in the tip in fluid flow communication with the second lumen; an inflow port in the second lumen, spaced in the proximal direction from the outflow port in the tip; and a surgical implement port facing in the proximal direction, at the portion of the second lumen that extends proximally from the proximal end of the handle, configured for insertion of a surgical implement in the distal direction to the tip along a straight insertion path. The method further comprises: removing the single-use portion from the sterile package and mounting by hand thereon a re-usable portion that comprises a touch-sensitive display screen configured to display video provided by said imaging assembly in the tip and to respond to touch to control imaging and illumination operations at the tip and display operations on the screen; and inserting the cannula tip and then the cannula into a patient's body and viewing on the screen images from the imaging assembly.

As used herein, the grammatical conjunctions “and”, “or” and “and/or” are all intended to indicate that one or more of the cases, object or subjects they connect may occur or be present. In this way, as used herein the term “or” in all cases indicates an “inclusive or” meaning rather than an “exclusive or” meaning.

As used herein the terms “surgical” or “surgery” refer to any physical intervention on a patient's tissues, and does not necessarily involve cutting a patient's tissues or closure of a previously sustained wound.

