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WO2024226665A2 - Structure de pointe et procédés pour procédures endoscopiques - Google Patents

Structure de pointe et procédés pour procédures endoscopiques Download PDF

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Publication number
WO2024226665A2
WO2024226665A2 PCT/US2024/026080 US2024026080W WO2024226665A2 WO 2024226665 A2 WO2024226665 A2 WO 2024226665A2 US 2024026080 W US2024026080 W US 2024026080W WO 2024226665 A2 WO2024226665 A2 WO 2024226665A2
Authority
WO
WIPO (PCT)
Prior art keywords
tip
camera
elongate
endoscope
working
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/026080
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English (en)
Other versions
WO2024226665A3 (fr
Inventor
Giacomo Basadonna
Alan Lucas
Bo Quinlan RANDOLPH
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Enlightenvue Inc
Original Assignee
Enlightenvue Inc
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Filing date
Publication date
Application filed by Enlightenvue Inc filed Critical Enlightenvue Inc
Publication of WO2024226665A2 publication Critical patent/WO2024226665A2/fr
Publication of WO2024226665A3 publication Critical patent/WO2024226665A3/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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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
    • A61B1/012—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
    • A61B1/005—Flexible endoscopes
    • A61B1/0051—Flexible endoscopes with controlled bending of insertion part
    • A61B1/0055—Constructional details of insertion parts, e.g. vertebral elements
    • A61B1/0056—Constructional details of insertion parts, e.g. vertebral elements the insertion parts being asymmetric, e.g. for unilateral bending mechanisms
    • 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
    • A61B1/005—Flexible endoscopes
    • A61B1/008—Articulations
    • 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
    • A61B1/06—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
    • A61B1/07—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 using light-conductive means, e.g. optical fibres
    • 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
    • A61B1/00078—Insertion part of the endoscope body with stiffening means

Definitions

  • the described technology relates generally to devices and methods for performing surgical procedures within a body lumen, cavity or other enclosed space.
  • Endoscopes are useful for surgical procedures, but suffer from various drawbacks that are addressed in the present disclosure.
  • This technology overcomes disadvantages of the previously known operative endoscopes, particularly micro-endoscopes.
  • the tip descries an endoscope hybrid tip.
  • the tip can have: an expandable interior channel and an endoskeleton. This can have an elongate backbone, two ribs extending therefrom, and a groove passage adjacent the backbone and ribs. The groove passage can be configured to allow passage of at least one expandable channel therethrough.
  • the tip can also have a resilient exterior layer configured to surround the endoskeleton and the expandable interior channel.
  • the expandable interior channel, endoskeleton, and resilient exterior layer can be configured such that when a surgical implement passes through the expandable interior channel, the instrument pushes against the endoskeleton and outwardly expands both the expandable interior channel and the resilient exterior layer, thereby bypassing the cndoskclcton to reach a surgery location beyond the endoscope.
  • the endoskeleton has at least three ribs extending from the elongate backbone at proximal, intermediate, and distal rib attachment positions, and the elongate backbone has at least two bendable sections located between the rib attachment positions.
  • two of the three ribs are configured to allow the expandable channel and any surgical implement extending therethrough to pass adjacent to the at least two ribs without changing trajectory, and a third rib is configured to direct the expandable channel and any surgical implement extending therethrough to change trajectory.
  • the third rib has an interior space configured to surround and support a camera and a light source, and when the third rib structure directs the expandable channel and any surgical implement extending therethrough to change trajectory, the expandable channel and any surgical implement extending therethrough bypass the camera and light source and the surgical implement extends out into the field of view of the camera.
  • the ribs can each include a passage for a control wire.
  • one of the ribs is a distal rib and comprises a control wire engagement portion at a distal terminus of the passage, configured to firmly engage with a portion of the control wire, such that when the control wire is pulled proximally, the ribs approach each other and the elongate backbone bends.
  • a camera can be adjacent the distal rib and mechanically coupled thereto such that bending of the elongate backbone aims the camera in a lateral direction.
  • the endoscope hybrid tip can further comprise a laser that is aimable using the control wire such that it can ablate or illuminate tissue in the field of view of the camera.
  • This disclosure further describes an endoscopic surgery system.
  • This can include an endoscope having a hub, a shaft having an elongate axis and a lateral width, and a working tip at a distal end of the shaft.
  • the system can have an energy source configured to provide optical energy through a fiberoptic cable that extends through the shaft to the working tip.
  • the system can also have a working channel extending continuously from the hub through the shaft to the tip, and a camera system comprising a connector cable in the shaft and a camera box at the working tip.
  • the system can have a resilient layer at an exterior of the working tip and a support structure at an interior of the working tip.
  • the support structure can be configured to position the camera box and an emitting portion of the energy source to both face distally outward from the working tip toward a working zone.
  • the support structure can also be configured to facilitate passage of surgical tools through the working channel at the tip by using a series of hard surfaces to laterally displace a leading edge of any such tools such that the leading edge thereof bypass the camera box, laterally stretch the resilient layer, and protrude from the working channel into the working zone.
  • the support structure comprises an articulated rigid structure having an elongate back generally aligned with the elongate axis of the shaft and a proximal appendage supported by the back and configured to allow each of the following to extend longitudinally thereby: the fiberoptic cable, the working channel, and the camera system’s connector cable.
  • the system can also have a central appendage supported by the back and configured to allow each of the following to extend longitudinally thereby: the fiberoptic cable, the working channel, and the camera system’s connector cable.
  • the system can also have a distal appendage supported by the back and configured to aim the camera box and the emitting portion of the energy source toward the working zone.
  • the distal appendage can comprise a camera holder and a deflector configured to act as one or more of the hard surfaces.
  • the support structure can be configured for controlled flexion.
  • the elongate back can have at least two flexion zones and the distal appendage can be configured to physically interface with a pull cable at a position laterally offset from a central axis thereof.
  • Each of the three appendages can provide a passage for the pull cable such that when the pull cable is pulled, the elongate back flexes, the distal appendage approaches the central appendage, and the distal appendage causes the camera box and the emitting portion of the energy source to aim toward a portion of the working zone that is toward the same side as the laterally offset position.
  • a method of introducing and aiming a camera, energy source, and surgical tool can comprise: providing an elongate shaft configured to extend to a surgical site; positioning a camera, an energy source, and an articulated support structure at the surgical end of the elongate shaft; and providing a resilient sleeve in a generally cylindrical space around the strong support structure.
  • the method can further comprise passing an elongate surgical tool having a stiff leading portion through the elongate shaft such that the leading portion passes within the resilient sleeve and adjacent to the articulated support structure, which displaces the leading portion laterally such that it stretches the resilient sleeve, bypasses the camera and energy source, and extends into a field of view of the camera and energy source.
  • the method can further comprise providing an elongate control device that physically interfaces with the articulated support structure to change an aiming direction of the camera and energy source.
  • the control device can be a pull wire configured to seat against a distal end of the articulated support structure and pass longitudinally therethrough, extending through the elongate shaft away from the surgical site, and the method can comprise pulling on the pull wire to thereby change the aiming direction.
  • the method can also comprise providing a laser as the energy source, using the laser to energize tissue at the surgical site, passing optical information from the camera back through the elongate shaft, and controlling an aiming direction of the camera and laser simultaneously from a proximal end of the shaft.
  • the articulated support structure can comprise a backbone and three rib sections configured such that a distal rib section supports and protects the camera, the more proximal ribs provide rigidity for the surgical end of the elongate shaft, and the ribs together provide a path within the resilient sleeve for any elongate surgical tool.
  • a continuous working channel can extend through the elongate shaft and through the resilient sleeve at the articulated support structure. Passing the elongate surgical tool through the elongate shaft can comprise passing the tool through the continuous working channel.
  • Some embodiments provide a surgical endoscopic system correlating optical feedback and mechanical control.
  • the system can comprise: an elongate tip control structure having a proximal end and distal end, a control wire extending therethrough and connected to the distal end, and an aiming direction aligned with an elongate axis of the elongate tip and directed past the distal end; a camera at the distal end of the tip control structure and configured to aim in the aiming direction; at least one surgical implement configured to aim or extend from the distal end; and an expandable sheath configured to tubularly surround the elongate tip and the camera; the control wire configured to cause the elongate tip to arch, thereby causing the aiming direction to move laterally from an initial, relaxed aiming direction.
  • the elongate tip control structure has at least three segments, proximal, middle, and distal, each comprising a passage for the control wire, wherein the middle segment’ s control wire passage provides greater lateral space than the distal segment’s passage provides for the control wire.
  • the surgical implement comprises a working channel that is also configured to aim in the aiming direction.
  • the system has at least one working channel that can expand adjacent the elongate tip control structure and within the expandable sheath, thereby causing the expandable sheath to expand.
  • the elongate tip control structure can have at least one radiopaque portion configured for visibility under radiation external to a patient.
  • the radiopaque portion can comprise one or more of the control wire and an enlarged mass at the end of the control wire formed from a dense metal material.
  • the surgical implement can comprise a laser configured to aim in the aiming direction.
  • the elongate tip control structure can further comprise one or more radiopaque features formed from a different material from and associated with the elongate tip control structure such that visualization from radiation external to a patient can demonstrate an orientation of the elongate tip control structure.
  • Figure 1 schematically shows a surgical system, having an exterior feature, an interior feature, and a supporting feature that is shown in perspective view.
  • Figure 2 shows the system of Claim 1, where the supporting feature is arched.
  • Figure 3 shows a surgical device with a detail of an operative portion at the working tip.
  • Figure 4 shows an operative portion for a surgical device, in assembled and exploded views.
  • Figure 5 shows a view of an articulating tip having a backbone.
  • Figures 6A-6F show views of an articulating tip from different perspectives.
  • Figures 7A-7I show various cross-sectional views of an articulating tip.
  • Figure 8 shows a perspective view of an articulating tip in a bent or arched configuration.
  • Figure 9A shows a side, section view of the arched articulating tip of Figure 8.
  • Figure 9B shows a side view of the arched articulating tip of Figure 8.
  • Figure 9C shows an end view of the arched articulating tip of Figure 8.
  • Figure 10A shows a side section view of an arched or bent articulating tip with a control wire.
  • Figure 10B shows a side view of an arched or bent articulating tip with a control wire.
  • Figure 10C shows a perspective view, from above and slightly proximal, of an arched or bent articulating tip with a control wire.
  • Figure 11A shows how an articulating tip can help guide a surgical tool along a surgical tool path.
  • Figure 11B shows an end view (looking back from beyond the distal end) of the same objects depicted in Figure 11 A.
  • Figure 11C shows a perspective view, from above and slightly distal, of an articulating tip in a relaxed, non-arched state.
  • Figure 1 ID shows a side view of an articulating tip in a relaxed, non-arched state.
  • Figure 12 shows two perspective views of a working end of a surgical instrument, with outer features shown as transparent to reveal inner structures.
  • Figure 13 shows side and perspective views of an articulated tip with outer material removed but -interior structures in place.
  • Figures 14A-14G show a sequence of perspective views as a surgical instrument or tool passes through the device.
  • Figure 14H shows an end-on view (from a position distal to the device) as a surgical instrument or tool emerges from the device, consistent with Figures 14E-14G.
  • Figure 15 is a flowchart of an example method of introducing and aiming a camera, energy source, and surgical tool.
  • Figure 16 shows a schematic view of surgical system.
  • Figure 17 shows a schematic view of surgical system including an expandable internal channel.
  • Figure 18 shows a schematic view of surgical system including a ring.
  • Figure 19 shows a schematic view of surgical system including a camera.
  • Figure 20 shows a schematic view of surgical system including a camera disposed within the ring.
  • Figure 21 shows a schematic view of surgical system with a backbone and ribs.
  • Figure 22 shows a top prospective view of a surgical system.
  • Figure 23 shows a top prospective view of a surgical system.
  • Figure 24 shows a prospective of a surgical system.
  • Figure 25 shows a top prospective view of a surgical system with an expandable internal channel.
  • Figure 26 shows a cut away side view of a surgical system.
  • Figure 27 shows a cut away side view of a surgical system.
  • Figure 28 shows an exploded view of an actuating device for a surgical system.
  • Figure 29 shows an internal view of an actuating device for a surgical system.
  • An endoscopic surgery system can have an endoscope with a hub, shaft and working tip.
  • An energy source can use a fiberoptic cable and a working channel that both extend through the shaft to the tip.
  • a camera at the working tip can be surrounded by a resilient layer and supported by a support structure within the tip.
  • the structure can aim the camera and energy toward a working zone.
  • the structure can also ease surgical tools in the working channel past the camera to the working zone, while the resilient layer stretches.
  • the structure can have a control that facilitates camera and beam aiming.
  • the structure can have a bending frame and multiple appendages that interface with elongate structures such as cables, tools, and channels.
  • the appendages can have guiding surfaces to facilitate tool passage and protect the camera.
  • the structure, resilient layer, and other aspects can cooperate to facilitate insertion of tine tools, and micro-endoscopic sizes for the most delicate surgeries.
  • Endoscopes are catheter-based devices that can be used to perform minimally-invasive procedures (e.g., surgery). Endoscopes 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.
  • Fiberscopes (or fiber-optic endoscopes) can include illumination fibers or light guides that direct light to illuminate the field of view.
  • Endoscopes can include imaging fiber bundles to transfer the image of an illuminated area to the camera. In diagnostic arthroscopy, after introducing the device into the patient's joint, a physician can shine light into that joint.
  • the camera provides an image of the joint, which is then viewed on a video monitor.
  • the physician docs not need to make a large incision.
  • Sterile fluid can be used to expand the joint, which increases visibility in the joint area and makes it easier for the physician to work.
  • Diagnosing and treating patients often involves examination of internal organs and structures. In "open surgery,” a large surgical cut or incision is made in the patient's skin and flesh. Doing so permits the doctor to see directly into and access the area being treated.
  • large surgical wounds cause significant patient pain, involve use of powerful anesthetics and analgesics such as narcotics to keep the patient comfortable during and after surgery, often take significant time to heal and limit post-surgical patient activity (particularly if muscle is cut to access the treatment area).
  • Arthroscopy is increasingly popular.
  • Common arthroscopic procedures examine and treat damaged tissue within various body joints, such as by removal or repair of tom cartilage portions of the meniscus, ligament, and tendon reconstruction, removal of loose debris, and trimming or shaving damaged articular cartilage.
  • Many million arthroscopies are performed worldwide each year, according to the American Orthopedic Society for Sports Medicine.
  • Other joints such as the shoulder, elbow, ankle, hip, and wrist can also be viewed and operated on through arthroscopy or endoscopy.
  • endoscopy systems are described. It is understood herein that when the term “endoscope” is mentioned herein (including variations of this root term), an endoscopy system 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 only a single endoscope are expressly contemplated, but that an endoscopy system is not necessarily limited to only a single endoscope.
  • the endoscopy system in accordance with some embodiments can include one or more working channels that extend within the lumen of the sheath.
  • the endoscopy system 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 the outer sheath 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.
  • an element e.g., image sensor
  • the endoscopy system in accordance with some embodiments can include additional working channels such as, for example, to allow a second tool to reach the distal end of the endoscope, a fluid flushing channel, a fluid suction channel, and one or more stylet working channels.
  • the endoscopy system can allow a single endoscope to be used for visualizing of the tissue (e.g., via the image sensor and illuminating element), expanding the tissue (e.g., via the fluid flushing channel), and performing a surgical procedure on the tissue (e.g., via the working channel).
  • the endoscopy system has an outer sheath comprising a lumen and an opening at the distal-most end of the sheath.
  • the endoscopy system can include an image sensor (for example, a camera) and an illuminating element that are disposed within the lumen of the sheath.
  • the illuminating element can be configured to pass light through the opening at the distal-most end of the sheath to illuminate a field of view.
  • the image sensor can be adapted to detect light reflected from the tissue illuminated by the illuminating element, thereby allowing a user to visualize tissue at the distal-most end of the endoscope.
  • the endoscopy systems are single-use endoscopy systems for use in surgical procedures.
  • a laser provides light to the illuminating element of the endoscopy system.
  • a laser can provide enough light via a single light guide fiber to illuminate a field of view.
  • the laser provides light via a single light guide fiber.
  • the use of a laser, and/or a laser and a single light guide fiber can yield an endoscopy system with a smaller diameter, thus minimizing invasiveness of the endoscopy system.
  • Endoscopes can have a light source and a camera.
  • Fiberscopes or fiberoptic endoscopes
  • Fiberscopes can include both illumination fibers or light guides to direct light which illuminates the field of view and imaging fiber bundles to transfer the image of an illuminated area to the camera.
  • the doctor can shine light into that joint.
  • the camera provides an image of the joint, which is then viewed on a video monitor. By viewing the joint of interest through the device, the doctor does not need to make a large incision.
  • Sterile fluid can be used to expand the joint, which increases visibility in the joint area and makes it easier for the doctor to work.
  • These single-port diagnostic procedures can be performed in a doctor's office and "walk in” or ambulatory surgery centers, e.g., using a 2.0 mm fiber optic arthroscope. These diagnostic procedures can be performed under local anesthetic to numb the area being examined and the patient can remain awake throughout the procedure.
  • Endoscopes are used to actively treat or operate on patients' joints.
  • the doctor can insert the endoscope into the joint. Additional holes or incisions can be provided to allow other tools to be used during the surgery to cut, shave, remove particles in the joint, or repair tissue.
  • the endoscope can include a working channel that allows surgical tools (e.g., biopsy forceps and other tools) to slide in and out of the joint.
  • Operative or therapeutic arthroscopic surgery can have limitations. Operative endoscopes with working channels for arthroscopy that are 3-4 mm in diameter can make the overall procedure more invasive and more taxing on the patient than when smaller diagnostic endoscopes are used.
  • a micro-endoscope can be an articulating device have flexion at its distal tip. This can be accomplished using a metal, ceramic, plastic, carbon-based, or other material to form a strong structural scaffold. Degrees of flection can be useful, for example, 30° of flexion at the tip. This can help position and/or aim numerous surgical implements such as a piezoelectric drill and procedure-specific instrumentation.
  • a laser fiber can be used with the disclosed tip having controlled flexion to deliver precise energy to sitespecific anatomy.
  • ENT ear, nose and throat
  • urology e.g., stone ablation
  • micro-spine discectomy for example.
  • the endoscopes described in this disclosure can be used for many applications, including arthroscopic joint examination and surgery for hands, shoulders and knees, as well as for biliary (relating to the liver), airway, ear/nose/throat, pulmonary, and vascular surgeries. Indeed, the described devices are useful for general surgical uses.
  • Figure 1 shows a surgical system 110. It can include an exterior feature 112, and interior feature 116, and an intervening supporting feature 120.
  • the exterior feature 112 can be the exterior of an elongate surgical instrument, which can be configured for insertion into passages of a living body, such as blood vessels.
  • the interior feature can be a surgical tool, a passage for accommodating one or more surgical tools, multiple such passages, a control device, such as a guide wire or a control wire, or more than one of these features or instruments.
  • the supporting feature 120 can comprise and articulated tip such as a support structure, directional or guiding structure, endoskeleton, etc.
  • the surgical system 110 can have multiple portions that work together to perform intricate surgeries in tiny spaces within a living entity such as a human body.
  • a supporting feature 120 is shown as articulating tip 124.
  • the articulating tip 124 can have a backbone 122 upon which are supported a distal rib 126, a central rib 127, and a proximal rib 128.
  • a proximal end 134 can be closer to a doctor or nurse, and a distal end 132 can be closer to a working end of a surgical system 110 such that surgical instruments, cameras, fiber optic lights and other implements can protrude from the distal end 132 for performing intricate surgery.
  • variable profile channels arc free to pass through the articulating tip and expand outwardly as warranted (constrained to some extent by the resiliency of those passages and/or an outer sleeve such as the elastomeric sleeve 1254 described elsewhere herein) to permit passage of implements or other surgical materials down the channels.
  • Figure 2 shows a surgical system 210 having an exterior feature 212, an interior feature 216, and a supporting feature 220.
  • the supporting feature 220 is in a bent configuration, which can facilitate directionality, movement, viewing or searching, illuminating, etc.
  • An embodiment of the supporting feature 220 is illustrated in three dimensions below. This illustration shows that the backbone 222 of the articulating tip 224 is in a bent configuration such that the distal rib 226 is slightly closer to the central rib 227 and the proximal rib 228 is also slightly closer to the central rib 227.
  • the proximal end 234 is angled downward, and the distal end 232 is also angled downward in this view.
  • the articulating tip 124 of Figure 1 and the articulating tip 224 of Figure 2 both illustrate interior passages that extend through the ribs 126, 127, 128, 226, 227, and 228. These interior passages can provide space for various surgical implements to pass through, and their shape and relative arrangement can provide more convenient passage and access for multiple surgical implements.
  • an endoscopy system comprises a piezoelectric element coupled to a working tip.
  • the piezoelectric element can drive the working tip to puncture a tissue of a patient such as bone.
  • the endoscopy system can be useful for performing microfracture surgery using a single endoscope and a single incision.
  • an endoscopy system comprises a hooked blade that can be distended from a working channel. Once distended, the hooked blade can incise a connective tissue.
  • the shaft of the endoscopy system can act as a tissue expander as it is slid alongside the median nerve, and then the hooked blade can be distended to incise a carpal ligament. Accordingly, in some embodiments, the endoscopy system can be useful for carpal tunnel surgery that utilizes only a single endoscopy system, and a single incision.
  • a stylet can be used for performing an arthroscopic procedure. Certain joints such as the hip or the back of the knee can be challenging for conventional endoscopy systems to visualize.
  • An operator can alter the stiffness of the shaft of an endoscopy system by interchanging curved stylets in the shaft.
  • the stylets can be configured to be advanced through a working channel of an endoscopy system as described herein. Accordingly, in some embodiments, an operator can use the stylet or stylets to adjust the tip location. The field of illumination and/or image capture can thus be altered by the use of the stylets.
  • the stylet or stylets can facilitate visualization of difficult- to-reach locations.
  • an articulated tip having the structures or characteristics described in Figure 1-14.
  • the cuff described in this patent can be advantageously incorporated with the endoskeletal structure described herein (referred to as an articulating tip).
  • the cuff may be free to pass through the articulating tip and expand outwardly as warranted, to form a seal or otherwise push against the side of an interior volume.
  • FIG. 3 shows a surgical device 340.
  • a surgical device 340 can comprise an endoscope for providing surgical access, for example.
  • the device can be a micro-endoscope.
  • At one end can be connectors such as a camera connector 348 and a fiber optic connector 342. These can connect to a main cable section. 346, which can then run toward a handle 344, a hub 345, a shaft 347, and terminate at an operative portion 350.
  • the hub 345 can provide additional access ports as shown (and these can lead to dedicated inner channels or tubes that can be expandable, in some embodiments).
  • the device 340 can have an elastomeric sleeve 354 at the terminus of the shaft 347. This elastomeric sleeve 354 can form a surrounding cover at a working end 352.
  • Surgical device 340 can be an endoscope. It can have an expandable tip (e.g., in the operative portion 350), a shaft (e.g., the shaft 347), a coupling hub (e.g., the hub 345), a connector assembly, and a connectors such as a USB connector (or other power, fluid, control, data, and/or optical connectors), for example.
  • the endoscope can have an overall working length (combined length of the shaft and the distal tip) of between 5 cm and 200 cm, preferably between 10 cm and 100 cm, and most preferably between 12 cm and 60 cm. The working length can be sufficient to allow the tip of the endoscope 1 to be positioned within the patient's body so that the relevant anatomy can be seen, while maintaining the coupling hub outside the patient's body.
  • the shaft can extend from the distal tip to the coupling hub.
  • the shaft can transmit torque (rotation) applied about a longitudinal axis of the shaft 3. Torque applied to the proximal end of the shaft is transferred along the length of the shaft and to the distal tip.
  • the shaft 3 is flexible and can be bent about a transverse axis of the shaft in a relatively small bend radius. This allows the endoscope to be maneuvered around anatomical structures during medical procedures. However, in other applications, some or the entire shaft is rigid or semi-rigid.
  • the shaft can be made from any biocompatible material with appropriate strength characteristics (e.g., providing flexibility and strength in tension and compression, as well as appropriate torque transfer from the proximal to the distal end).
  • Materials from which the shaft can be made include biocompatible polyamides, polyesters, polyetheretherketones, poly etherurethanes, polyimides, polytetrafluoroethylene, and polyurethane epoxies.
  • reinforcing materials can be incorporated into the shaft 3.
  • Such reinforcing materials include copper alloys, nickel alloys (e.g., Nitinol), stainless steel, and high modulus plastics such as polyimides.
  • the coupling hub can contain one or more connectors for tools, flushing fluid, and a stylet, as well as optional electronics.
  • the coupling hub can have a size and shape which accommodates these components.
  • Electronics within the coupling hub can include a PCA with circuitry to operate the endoscope and a camera signal transmission system that are discussed below.
  • the PCA can function as an interconnection to external control circuitry outside of the endoscope. If electronics internal to the hub are not otherwise desired, the hub can be quite small and can serve as a connection joint between the other tubes, wires, and optical fibers.
  • the hub can be made of a biocompatible plastic, such as polycarbonate, acrylic, acrylonitrile butadiene styrene (ABS), cast epoxy, and thermoset plastics.
  • a biocompatible plastic such as polycarbonate, acrylic, acrylonitrile butadiene styrene (ABS), cast epoxy, and thermoset plastics.
  • ABS acrylonitrile butadiene styrene
  • thermoset plastics formed metal housings using biocompatible materials, such as several grades of stainless steel or titanium, are also possible.
  • the coupling hub can have a distal portion and proximal portion and include one or more ports or connectors and strain relief features. These connectors can include seals to provide fluid tight seal between coupling hub and the connectors (e.g., a LUERLOK ® lock component).
  • the connectors can attach firmly to the coupling hub and allow doctors to introduce tools and fluids at the hub that can be used at the distal tip of the endoscope. This can be achieved by gluing, heat- welding, potting with thermoset plastic or epoxy, RF welding, screwing them on with a threaded connection, solvent bonding, ultrasonic welding, or combinations of these processes. Any or all of the connectors can be attached to a flexible tube, which enters the hub.
  • a flushing channel connector allows fluid to be introduced at the hub, which can travel through a flushing lumen.
  • a stylet channel connector can allow for a stylet (not shown) to be inserted at the hub and into a stylet channel.
  • the stylet can be intended to influence the shape of the endoscope's flexible shaft.
  • a malleable and resilient wire made of materials such as 300-series stainless steel can be bent into a desired curvature or angle, and inserted through the stylet channel causing the flexible endoscope to conform to such curvature or angle.
  • the working channel connector 10 allows tools to be passed from the hub through the working channel, within the shaft, and down to the working channel portion within the distal tip.
  • More than one working channel can be included.
  • variable profile distal tips can allow the doctor to insert the endoscope through a minimal incision or puncture size (e.g., for a 12 gauge needle) while it is in a low-profile configuration. Once the endoscope is in the area to be treated, the tip section is enlarged.
  • An enlarged profile configuration (see view 14h of Figure 14, for example) can be is achieved, for example, by passing a full 1.0 mm diameter tool through the working channel tip 23, and/or flushing fluid (0.9% saline in sterile water) through the flushing channel 24 at a rate sufficient to expand the flushing channel 24 at the distal tip 2.
  • Three connectors can be used for a flushing lumen, stylet, and working channel, respectively.
  • As one connector could be used, or as many connectors as needed for the flushing lumen, stylet, and working channel features of the particular endoscope.
  • an endoscope with two working channels, a stylet, and a flushing lumen can have four separate connectors.
  • An electrical cable and a USB connector can provide an interface between circuitry within the coupling hub and external devices. They can include conductors for powering a light source within the coupling hub and have contacts for transmitting signals outputted by a camera to a connector (such as a USB connector). Multiple cables can be used with, for example, a first cable conducting power to a light emitting diode (LED) light source in the coupling hub (which can transmit light along a fiber-optic path), and a separate second cable for transmitting signals received from a camera.
  • LED light emitting diode
  • Connectors can connect to external control / display devices or into an electronic interface box, which can translate the signals into those used by the external control or display devices.
  • Connectors e.g., a USB connector
  • other wired connections e.g., HDMI
  • wireless connections e.g., Bluetooth, WiFi
  • a coupling hub may undergo various forces during use, including bending forces. Strain relief features may protect the hub and its components from these forces. Such features can include relatively hard injection molded thermoplastics (e.g., acrylonitrile butadiene styrene (ABS)), or more flexible materials such the TPEs previously identified. When a TPE is used, it preferably has a higher durometer value than expandable tip components.
  • ABS acrylonitrile butadiene styrene
  • Figure 4 shows additional views of an operative portion 450 for a surgical device such as the surgical device 340 shown in Figure 3.
  • Figure 4 includes an exploded view where the elastomeric sleeve 454 has been separated for illustration purposes to reveal interior structures.
  • an articulating tip 424 having a backbone 422 is shown generally containing and surrounding a fiber optic light 466 and a camera 462, with supporting features such as cables running back through the operative portion and terminating at a camera 462 and a fiber optic light 466.
  • a shoe 464 can be positioned such that the fiber optic light 466 passes through an interior passage of the shoe 464, which also can sit on a lateral surface of the camera 462.
  • the operative portion 450 (as defined by an elastomeric sleeve 454, for example), can have a length of between 3 mm and 50 mm, preferably between 7 mm and 15 mm, and most preferably between 8 mm and 10 mm, for example.
  • the operative portion can enlarge and contract. In a low-profile state, it can have a reduced cross-sectional area with an outer diameter of between about 1.5 mm and 20 mm, preferably between about 1.5 mm and 5 mm, and most preferably between about 1.5 mm and about 2.0 mm. In an enlarged-profile or expanded state, it can have an enlarged cross-sectional area that will accommodate passage of one or more tools through one or more channels.
  • an enlarged-profile can accommodate passage of a tool having a circular cross-sectional shape with a diameter of between 1.8 mm and 20 mm, preferably between 2 mm and 5 mm, and most preferably between 1 mm and 2 mm, for example.
  • the profile change allows tools to pass the camera 22, and ultimately to exit the distal tip of the endoscope. This enlargement is not obstructed by the presence of the articulated tip 424, because even though it is a generally rigid structure, it has side openings that allow lateral expansion of the elastomeric sleeve.
  • a tip can include illumination fibers, such as one or more flexible fiberoptic light-guides. These fibers can carry light from a light source in the coupling hub to the distal tip of the endoscope, illuminating a field of view. Illumination fibers can be made of glass, PMMA or other light transmitting materials. Combinations of different sized fibers can be used, as long as they fit within the cross-sectional area of the distal tip in its low-profile configuration and provide sufficient illumination intensity.
  • illumination fibers such as one or more flexible fiberoptic light-guides. These fibers can carry light from a light source in the coupling hub to the distal tip of the endoscope, illuminating a field of view. Illumination fibers can be made of glass, PMMA or other light transmitting materials. Combinations of different sized fibers can be used, as long as they fit within the cross-sectional area of the distal tip in its low-profile configuration and provide sufficient illumination intensity.
  • the camera 462 and illumination fibers can be positioned so the area to be imaged or operated on is sufficiently illuminated. In the configuration shown, the camera 462 can be approximately in the center of the distal tip.
  • a working channel, a secondary channel (e.g., flushing lumen) and any illumination feature can be angularly distributed around the circumference as further shown in Figure 12.
  • An outer cover e.g., an elastomeric sleeve 454
  • any channels working and secondary
  • an outer cover can be made of sterilizable polymeric materials.
  • these structures are configured so that they can change shape or expand.
  • Each of these structures can be made from the same material, or the materials can be different.
  • each can be constructed of biocompatible elastomeric tubing (e.g., latex rubber, silicone rubber, or various USP Class 6 compatible TPEs). Exemplary TPEs are mentioned above.
  • Figure 5 shows a view of an articulating tip 524 having a backbone 522.
  • the backbone 522 can have a distal thin portion 572 and a proximal thin portion 574. These thin portions can intervene between where a distal rib 526, a central rib 527, and a proximal rib 528 attach to the backbone 522 at support sections such as proximal rib support 576 and central rib support 577.
  • This figure illustrates how these rib supports and ribs can have smooth or otherwise contoured shapes, edges, and profiles which can assist in threading surgical implements through a surgical system 110 and in particular through the articulating tip 524, e.g., for surgical operations.
  • Figure 5 also shows a control structure 578 that can interact with a control device such as a control wire, for example.
  • Figures 6A-6F show several views of an articulating tip consistent with the articulating tip 524 of figure 5.
  • 6a shows a side view with the backbone 622 toward the bottom and the distal rib 626, central rib 627, and proximal rib 628 toward the top.
  • the proximal rib support 676 and the central rib support 677 are labeled.
  • 6b shows a top view looking down at the backbone 622, with the distal thin portion 672 and the proximal thin portion 674 labeled.
  • These thin portions are also labeled in 6c, which shows a side view.
  • a guide angle 680 is labeled with an a.
  • This guide angle 680 can also have a contour such as the taper 682 labeled in 6f.
  • 6e shows an end-on view, from the proximal side of an articulating tip.
  • 6d shows an end-on view from the distal side looking back in the proximal direction toward a working end of an articulating tip.
  • a leading edge 686 can be seen in this view, which is the front of rib support 677.
  • a bullseye marking has been added to views 6e and 6d to represent where a control wire can be placed within the illustrated structure, but the bullseye does not represent the structure itself.
  • An articulating tip can have a generally cylindrical outer shape, with an outer diameter of 1.6 mm and a length of 7.9 mm.
  • the articulating structure in a relaxed (not bent) configuration, can have a distance between ribs of 0.8 mm, and the length of each thin backbone portion can be 2.7 mm (while the central backbone portion between these two is shorter — e.g., 0.9 mm long.
  • the length of the thinner portions and the distance between ribs can be useful in determining how far the articulating tip can bend, so the dimensions described here generally correspond to a configuration that bends by 30°.
  • other structures can provide constraints on the bendability of an articulating tip, similar to the structural constraints provided by spine protuberances in the animal kingdom, for example.
  • the guide angle 680 can be the same as an expected overall bend angle for an articulating tip 124.
  • the guide angle 680 labeled “a” in Figure 6 can be 30° when the structure has the dimensions described here (or proportional dimensions thereto).
  • an overall width of the distal rib 626 can be 1.41 mm (which can correspond to the width seen in 6b and 6f) and be wider than the generally tubular structure of the rest of the articulating tip (see the outer diameter of 1.6 mm corresponding to the height of side views 6c and 6a).
  • Figures 7A-7I show various cross-sectional views of an articulating tip 724. 71 corresponds to 6E from Figure 6, and 7H corresponds to 6D from Figure 6. 7A is a section taken along the central longitudinal axis of the articulating tip 124 in Figure 1.
  • 7B is a transverse cross-section taken toward the distal end (at the left in this figure)
  • 7C is a transverse cross-section taken slightly proximally
  • 7D is a transverse cross-section taken more proximally — through a central rib
  • 7E is a transverse cross-section taken through the central rib support 777
  • 7F is a transverse cross-section taken further toward the proximal end
  • 7G is a transverse cross-section taken even nearer the proximal end — through the distal rib support 776.
  • 7B and 7C illustrate transverse cross-sections through a distal rib 726
  • 7D and 7E provide cross-section views of a central rib 727
  • 7F and 7G provide cross-section views of proximal rib 728.
  • These sectional views reveal differing interior profiles along the length of the articulating tip.
  • 7C, 7D, and 7F show at the top a cross-section view of the distal thin portion 772 and the proximal thin portion 774 of the backbone 722.
  • 7C shows a proximal-facing edge contour 782 which can help guide or divert surgical implements in their passage through the articulating tip 724.
  • Figures 7A-7I are also useful to provide example dimensions.
  • One dimension that can be important is the diameter of the small cylindrical passage in views 7B (extending inward from frustoconical wire seat 792) and 7F (narrow tube 790), since that can allow passage of a control wire having an enlarged tip 1011 (discussed further with respect to Figure 10).
  • the inner diameter can be 0.08 mm for both of these, and length of the portion of the proximal rib 728 containing this narrow tube 790 can be 0.5 mm.
  • the larger inner diameters of views 7D and 7E can be 0.51 mm
  • the inner diameter of the passage shown in view 7G can be 0.35 mm
  • its length can be 1.25 mm
  • the overall length of the articulating tip can be 7.9 mm
  • the length of the central rib 727 can be 2.8 mm
  • the distances between ribs can be 0.8 mm
  • the vertical width of the thin backbone portions 772 and 774 can be 0.2 mm.
  • Figure 8 shows and articulating tip 824 in a bent configuration. It has a backbone 822, a distal thin portion 872 and a proximal thin portion 874. It also has a distal rib 826, a central rib 827, and a proximal rib 828.
  • Figure 9A shows a side, section view of the bent or arched articulating tip of Figure 8.
  • Figure 9B shows a side view
  • Figure 9C shows an end view.
  • Figure 9A shows a section taken along the line B-B illustrated in Figure 9C.
  • Figure 9B shows a side view and labels an overall bend 997, labeled with an x, as well as two subangles 996, each labeled with a y.
  • Distal thin portion 972 and proximal thin portion 974 can both allow for bending with their thin, flat geometry. This can result in the sub angles 996 (distal and proximal), thereby establishing the overall tip bend angle 997.
  • Figure 10A shows a side section view of an arched or bent articulating tip 1024 with a control wire.
  • Figure 10B shows a side view of an arched or bent articulating tip 1024 with a control wire.
  • Figure 10C shows a perspective view, from above and slightly proximal, of an arched or bent articulating tip 1024 with a control wire.
  • Figure 10A provides a cross-section similar to Figure 9A.
  • Figure 10B provides a side view similar to Figure 9B.
  • Figure 10C provides a perspective view, similar to Figure 8.
  • an overall bend angle is shown of 35°, and two sub angles are shown, each bending 17.5°.
  • a pull wire 1013 can pass through the ribs of the device and can have an enlarged distal tip 1011.
  • a pull wire 1013 can be pulled by a user at a proximal end to cause the bend such as the 35° bend shown in this figure.
  • an articulated tip having the structures or characteristics described in Figure 1-14.
  • implements such as a piezoelectric element, stylet or hooked blade, may pass through variable profile channels and an expandable tip, incorporated with the endoskeletal structure described herein (referred to as an articulating tip).
  • the piezoelectric element, stylet or hooked blade are free to pass through the articulating tip and shift or expand outwardly as warranted (constrained to some extent by the resiliency of surrounding structures such as an expandable working channel and/or a sleeve (e.g., the elastomeric sleeve 1254 described elsewhere herein) as such implements are positioned for surgery.
  • a sleeve e.g., the elastomeric sleeve 1254 described elsewhere herein
  • Figure 11A shows how an articulating tip can help guide a surgical tool along a surgical tool path.
  • Figure 11B shows an end view (looking back from beyond the distal end) of the same objects depicted in Figure 11 A.
  • Figure 11C shows a perspective view, from above and slightly distal, of an articulating tip in a relaxed, non-arched state.
  • Figure 11D shows a side view of an articulating tip in a relaxed, non-archcd state.
  • Figures HA and 1 IB show how an articulating tip 1124 can help guide a surgical tool along a surgical tool path 1113.
  • a guide angle 1180 which can be 30° as illustrated in this example, can be formed with a contoured guide surface 1121.
  • a side groove passage opposite from and similar to the one illustrated at 1123 can help guide the surgical tool through an elongate path in the articulating tip 1124.
  • the side passage can comprise series of aligned grooves located between sections of a backbone and the protruding portions of related ribs, similar to the articulating features of a mammalian endoskeleton.
  • a surgical tool passing through this series of aligned grooves can also be within a larger tubular structure that surrounds the entire articulating tip 1124, and the tool can also be passing through and/or guided by an interior tube or channel, for example (see, e.g., the working and secondary channels described with respect to Figure 12 below).
  • a secondary series of groove channels, including the side groove passage 1123, can guide a second surgical implement (such as a channel for Hushing fluid, another tool, etc.)
  • a surgical tool can exit a surgical device at a tool exit angle 1119 such as the angle of 3.25° shown here. This angle can be measured from a central axis.
  • a surgical tool may have different lateral profiles and can have a leading portion that is more rigid and/or wider than a trailing portion.
  • Figure 12 shows views of a working end 1252 of a surgical instrument.
  • This working end can be consistent with the structures shown in Figure 4, for example, and can comprise an operative portion 450.
  • An elastomeric sleeve 1254 can be provided to surround other structures at the working end 1252. These structures can include, for example, a working channel 1233 that is shown here in a non-expanded state, compressed and forming an arcuate cross-section toward the right side of the interior of the working end 1252. A similar but optionally smaller secondary channel 1237 is shown compressed against the left side.
  • the elastomeric material of the sleeve 1254 can expand to accommodate passage of implements, materials, fluid, etc.
  • a fiber-optic tip 1266 is also seen adjacent a camera 1262.
  • An articulated tip can also be seen partially concealed by the elastomeric sleeve 1254, in both perspective views.
  • Figure 13 shows an articulated tip 1324 with the elastomeric sleeve material removed.
  • a fiber optic cable 1345 can be seen leading toward the fiber optic tip 1366, which is secured or positioned within the shoe 1364.
  • a camera harness 1343 can be seen passing alongside various ribs of the articulated tip 1324 (through side groove channels such as the side groove passage 1123 of Figure 11) and connecting with the camera 1362 at the distal end of the device.
  • the fiber optic cable 1345 and the camera harness 1343 together pass to the side of proximal rib 1328 and central rib 1327.
  • the fiber optic cable 1345 and the camera harness 1343 both pass through the interior of the distal rib 1326, which is large enough to accommodate their passage.
  • a distal rib can be configured to physically contain at least a portion of or fulfill the role of the shoe 1364 and can also position and or contain the camera 1362.
  • a surgical tool can pass to one side of the ribs 1328, and 1327 while the fiber optic cable 1345 and camera harness 1343 pass to the other side of those same ribs.
  • the fiber optic cable 1345 in the camera harness 1343 can pass through the distal rib 1326 while the surgical instrument passes to the side, guided by the contoured guide surface 1121, which is not visible in figure 13.
  • this channel may advantageously be smaller or shaped differently than another channel (see, e.g., working channel 1233 of Figure 12) that need not share space.
  • a camera harness 1343 can be referred to as a camera cable. It can extend from a camera a to a coupling hub.
  • the camera cable can be a simple signal conducting wire (e.g., a 24 AWG gauge copper wire with a diameter of about 0.52 mm), or a ribbon cable with several insulated conductors.
  • Exemplary conductor compositions include copper, copper alloys, MP35N, DFT, platinum, platinum/iridium, tungsten, gold, and stainless steel.
  • the conductors can be bare, tinned, silver-plated, or gold-plated.
  • FIGS. 14A-14G show a sequence of perspective views as a surgical instrument or tool passes through the device.
  • Figure 14A shows an initial stage with the camera 1462 visible at the distal end of the device.
  • a surgical tool 1453 can be seen entering the elastomeric sleeve section from the (potentially more rigid) shaft at the right.
  • a sleeve or elastomeric tip has been removed in Figures 14D, 14C and 14D.
  • Figure 14B labels a fiber optic tip 1466 seen to be protruding next to the camera 1462.
  • the surgical tool 1453 continues to pass by the support ribs of an articulating tip within the device.
  • the surgical tool 1453 begins to encounter a contoured guide surface (see, e.g., the surface labeled 1121 in Figure 11) of an articulating tip within the device.
  • FIG 14E the surgical tool 1453 is seen protruding out the distal tip while the elastomeric sleeve 1454 is shown to be bulging to the side to accommodate passage of the surgical tool 1453.
  • Figure 14F the surgical tool 1453 protrudes even farther, and in Figure 14G the surgical 20 1453 continues to extend beyond the distal tip.
  • Many surgical tools have a stiff or less bendable portion at their distal tip, and a more pliable portion located proximally.
  • a surgical tool 1453 will commonly allow for the articulating tip to be deployed such that the tool can be guided to turn laterally as a control wire is engaged or pulled tight by a user at the proximal end of a surgical tool.
  • the tool can be viewed by the camera 1462 and is therefore useful an operative for many surgical procedures that use both a tool and the camera.
  • Figure 14H shows an end-on view (from a position distal to the device) as a surgical instrument or tool emerges from the device, consistent with Figures 14E-14G.
  • the surgical tool 1453 is located at the right, filling and expanding a working channel 1433 while a camera tip 1462 is also seen facing out from an articulating tip 1424.
  • a shoe 1464 surrounds and contains a fiber optic tip 1466, and a working channel 1437 is seen to the left of the figure, not currently expanded.
  • FIG. 15 is a flowchart of an example method of introducing and aiming a camera, energy source, and surgical tool.
  • Step 1510 provides an elongate shaft configured to extend to a surgical site.
  • Step 1520 positions a camera, an energy source, and an articulated support structure at the surgical end of the elongate shaft.
  • Step 1530 provides a resilient sleeve in a generally cylindrical space around the strong support structure.
  • Step 1540 passes an elongate surgical tool having a stiff leading portion through the elongate shaft such that the leading portion passes within the resilient sleeve and adjacent to the articulated support structure, which displaces the leading portion laterally such that it stretches the resilient sleeve, bypasses the camera and energy source, and extends into a field of view of the camera and energy source.
  • the method can further comprise providing an elongate control device that physically interfaces with the articulated support structure to change an aiming direction of the camera and energy source.
  • the control device can be a pull wire configured to seat against a distal end of the articulated support structure and pass longitudinally therethrough, extending through the elongate shaft away from the surgical site, and the method can comprise pulling on the pull wire to thereby change the aiming direction.
  • the method can also comprise providing a laser as the energy source, using the laser to energize tissue at the surgical site, passing optical information from the camera back through the elongate shaft, and controlling an aiming direction of the camera and laser simultaneously from a proximal end of the shaft.
  • the articulated support structure can comprise a backbone and three rib sections configured such that a distal rib section supports and protects the camera, the more proximal ribs provide rigidity for the surgical end of the elongate shaft, and the ribs together provide a path within the resilient sleeve for any elongate surgical tool.
  • a continuous working channel can extend through the elongate shaft and through the resilient sleeve at the articulated support structure. Passing the elongate surgical tool through the elongate shaft can comprise passing the tool through the continuous working channel.
  • FIG. 16 shows a surgical system 1600.
  • the surgical system 1600 may be similar or identical to the surgical systems 110 or 210 described above.
  • the surgical system may include an exterior feature 1610, and a wire 1620, and a wire connection feature 1630.
  • the exterior feature 1610 can be the exterior of an elongate surgical instrument, which can be configured for insertion into passages of a living body, such as blood vessels.
  • the exterior feature 1610 may be an elastomeric sleeve as described herein.
  • the exterior feature may include a distal end 1612 and a proximal end 1614.
  • the distal end 1612 is expandable to accommodate the passage of a tool or other object within the exterior feature 1610.
  • proximal end 1614 may be more rigid than the distal end 1612 such that the proximal end 1614 does not expand or does not expand as far as the distal end 1612 expands.
  • the wire 1620 is disposed within the exterior feature 1610.
  • the wire 1620 is a pull wire, a guide wire or a control wire.
  • the wire 1620 is connected to a wire connected member 1630.
  • the wire 1620 is connected to the wire connection member 1630 on a first side 1632 of the wire connection member 1630.
  • the wire 1620 is connected to a wire connection member 1630 such that when the wire 1620 is pulled, the distal end 1612 of the exterior feature 1610 bends.
  • the surgical system 1600 may include an expandable internal channel 1640.
  • the expandable internal channel 1640 may be similar or identical to the variable profile working channel as described herein.
  • the expandable internal channel 1640 is positioned within the external feature 1610 and is configured to expand to accommodate passage of a tool.
  • the expandable internal channel 1640 is positioned adjacent the wire connection member 1630.
  • the external feature 1610 is configured to expand to accommodate the expansion of the expandable internal channel 1640.
  • Figure 18 shows another embodiment of the surgical system 1600.
  • the wire connection member 1630 is a ring 1650.
  • the ring 1650 is rigid.
  • the wire 1620 is connected to a first half 1654 of the ring 1650.
  • the first half 1654 of the ring 1650 is rigid.
  • the first half 1654 of the ring 1650 is more rigid than a second half 1656 of the ring 1650.
  • the second half 1656 of the ring 1650 may be flexible.
  • the wire connection member 1630 is a half ring.
  • the wire connection member 1630 is a camera 1660 similar or identical to the cameras described herein.
  • the wire 1620 may be attached to a first side 1662 of the camera. In this configuration, pulling the wire 1620 causes the camera 1660 to change orientations, thereby changing the field of view of the camera 1660.
  • the external feature 1610 is configured to bend as the camera 1660 changes orientations.
  • Figure 20 shows a surgical system 1600.
  • the wire connection member 1630 is a ring 1650 or a half-ring.
  • the wire 1610 is connected to the ring 1650 on a first half 1654 of the ring 1650.
  • the system further includes a camera 1660.
  • the camera 1660 is disposed within the ring 1650. In some embodiments, the camera 1660 is attached to the ring 1650 such that when the wire 1610 is pulled the field of view of the camera 1660 is changed.
  • the system 1600 further includes an expandable interior channel 1640.
  • the expandable interior channel 1640 is disposed within the external feature 1610 adjacent to the ring 1650 or the camera 1660.
  • the expandable interior channel 1640 is configured to expand to accommodate the passage of a tool.
  • the second half 1656 of the ring 1650 is configured to expand or deform when the expandable interior channel 1650 expands to accommodate the expansion of the expandable interior channel 1650.
  • Figure 21 shows a view of a wire 1620 connected to a ring 1650.
  • the wire 1610 may include a backbone 1670.
  • the backbone 1670 may be similar to or identical to the backbones described herein.
  • the backbone 1670 may be attached to the external feature 1610.
  • the backbone 1670 is connected to the wire 1620.
  • the backbone 1670 is configured to provide support to the external feature 1610 when the external feature 1610 is bent by the wire 1620 pulling on the ring 1630.
  • the backbone 1670 beneficially allows the external feature 1610 to bend without kinking.
  • the backbone 1670 may include at least one rib 1680.
  • the rib 1680 may be similar or identical to any of the ribs described herein.
  • the at least one rib is 1680 configured to provided additional support to the backbone 1670.
  • the at least one rib 1680 is configured to prevent the backbone 1670 from bending too far.
  • Figure 22 shows a top perspective view of a surgical system 1600 similar or identical to the surgical system 1600 as seen in Figure 20.
  • the surgical system includes an exterior feature 1610, a wire 1620, a wire connection member 1630, a expandable internal channel 1640, a camera 1660, and a light source 1690.
  • the external feature 1610 can be the exterior of an elongate surgical instrument, which can be configured for insertion into passages of a living body, such as blood vessels.
  • the external feature 1610 may be an elastomeric sleeve as described herein.
  • the external feature 1610 is similar or identical to the exterior features described herein.
  • the external feature 1610 may be a resilient sheath.
  • the exterior feature may include a distal end 1612 and a proximal end 1614.
  • the distal end 1612 is expandable to accommodate the passage of a tool or other object within the exterior feature 1610. In some embodiments, only a portion of the distal end 1612 is expandable.
  • the proximal end 1614 may be more rigid or resilient than the distal end 1612 such that the proximal end 1614 does not expand or does not expand as far as the distal end 1612 expands. In some embodiments, the proximal end 1614 is configured to not expand at all.
  • the external feature 1610 has sufficient resilience to resist kinking when a tension force is applied to the tip of the external feature.
  • the surgical system 1600 also includes a wire connection member 1630.
  • the wire connection member 1630 may be referred to as a rigid skeleton. As seen in Figure 22, the wire connection member 1630 is disposed within the exterior feature 1610. In some embodiments, the wire connection member 1630 has a center orifice where tools, wires, lights, cameras or other objects may be threaded through or located. In some embodiments, the wire connection member 1630 is substantially rigid such that it does not expand.
  • the surgical system 1600 includes a wire 1620.
  • the wire 1620 is connected to the wire connection member 1630.
  • the wire 1620 is threaded through the central orifice of the wire connection member 1630 and is attached to the wire connection member 1630 at a top portion of the wire connection member 1630.
  • the wire 1620 may be external to the wire connection member 1630.
  • the wire 1620 may be located in between the wire connection member 1630 and the external feature 1610.
  • the wire 1620 is connected to the wire connection member 1630 such that when the wire 1620 is pulled the wire connection member 1630 bends, thereby causing the distal end 1612 of the external feature 1610 to bend.
  • the wire 1620 is connected to the wire connection member 1630 such that the wire is offset from a central axis of the external feature.
  • the surgical system 1600 further includes a camera 1660.
  • the camera 1660 may be similar or identical to the cameras described herein. As seen in Figure 22, the camera 1660 is disposed within the central orifice of the wire connection member 1630. In some embodiments, the camera 1660 is secured within the central orifice of the wire connection member 1630 such that the camera is not able to move independently from the wire connection member 1630. In some embodiments, the field of view of the camera 1660 is changed when the wire 1620 is pulled and the wire connection member 1630 bends.
  • the expandable internal channel 1640 is disposed within the external feature 1610In some embodiments, the expandable internal channel 1640 is disposed between the wire connection member 1630 and the external feature 1610. In some embodiments, the expandable internal channel 1640 is expandable between a low-profile configuration (as seen in Figure 22) and an expanded configuration. In some embodiments, the expandable internal channel 1640 is composed of a flexible material such that the pressure of the wire connection member 1630 and the external feature 1610 against the expandable internal channel 1640 causes the expandable internal channel 1640 to be in the low-profile configuration.
  • the expandable internal channel 1640 is configured to accommodate passage of a tool, such as a surgical apparatus, or object through the expandable internal channel 1640.
  • the expandable internal channel 1640 When a tool or object is pushed the expandable internal channel 1640, the expandable internal channel 1640 is configured to expand from the low-profile configuration to the expanded configuration. As a consequence of the expandable internal channel 1640 expanding, the external feature 1610 also expands to accommodate the expansion of the expandable internal channel 1640.
  • the system 1600 also includes a light source 1690.
  • the light source 1690 may be similar or identical to the other light sources described herein.
  • the light source 1960 is threaded through the central orifice of the wire connection member 1630.
  • the light source 1690 is located adjacent to the wire 1620.
  • the light source 1690 may be located external to the wire connection member 1630.
  • the light source 1690 is located in between the wire connection member 1630 and the external feature 1610.
  • Figures 23 and 24 show different views of a surgical system 1600 with the wire connection member pushed out from the external feature 1610.
  • the wire connection member 1630 includes a plurality of rib gaps 1634, a plurality of ribs 1636, a tongue 1638, a channel gap 1635 and a support 1637.
  • the rib gaps 1634 are referred to as bilateral openings. As seen in Figure 23, the plurality of rib gaps 1634 may be located along the length of the wire connection member 1630. In some embodiments, the space in between adjacent rib gap 1634 is substantially the same along the length of the wire connection member 1630. In some embodiments, the rib gaps 1634 are formed along the perimeter of the wire connection member 1630 such that the rib gap 1634 extends from a first position 1631 of the wire connection member 1630 and terminates at a second position 1633 of the wire connection point 1630. In some embodiments, the second position 1633 is located near the first position 1631. In some embodiments, the rib gaps 1634 located at the same longitudinal position as the channel gap 1635 are shorter than the other rib gaps. The rib gaps 1634 beneficially allow the wire connection member 1630 to bend in response to the wire 1620 being pulled.
  • the plurality of ribs 1636 are formed by the plurality of rib gaps 1634, each rib 1636 being located in between a pair of adjacent rib gaps 1634.
  • the plurality of ribs 1636 beneficially allow the wire connection member 1630 to bend in response to the wire 1620 being pulled, while simultaneously preventing the exterior feature 1610 of the system 1600 from kinking.
  • the channel gap 1635 is formed on the wire connection member 1630.
  • the channel gap 1635 may also be referred to as a lateral opening.
  • the channel gap 1635 is formed opposite to the wire 1620.
  • the channel gap 1635 may have a sloping perimeter such that the channel gap 1635 is wider near the top of the wire connection member 1630 than at the bottom end of the channel gap 1635.
  • the channel gap 1635 is configured for a channel, such as the expandable internal channel 1640 described herein, to be threaded through the central orifice of wire connection member 1630 and emerge through the channel gap 1635.
  • the tongue 1638 is located within the channel gap 1635. In some embodiments, the tongue 1638 abuts into the central orifice of the wire connection member 1630. In some embodiments, the tongue 1638 is configured to contact the opposite side of the wire connection member 1630. In some embodiments, the tongue 1638 contacts at least one wire extending through the central orifice of the wire connection member 1630, including the wire 1620, any electrical, data, or control wires connected to the camera 1660, and any similar wires connected to the light source 1690. In some embodiments, the tongue 1638 is configured to guide a channel being pushed through the central orifice of the wire connection member 1630 such that the channel emerges through the channel gap 1635.
  • the wire connection member 1630 further includes a support 1637. As seen in Figure 23, the support 1637 may be located at the top of the tongue 1638. In some embodiments, the support 1637 abuts into the central orifice of the wire connection member 1630. In some embodiments, the support 1637 secures the camera 1660 and beneficially prevents the camera 1660 from being pulled further down in the central orifice of the wire connection member 1630.
  • Figure 25 shows a prospective view of a surgical system 1600 with an expandable internal channel 1640 threaded through the wire connection member 1630.
  • the expandable internal channel 1640 up through the bottom of the wire connection member 1630 through the central orifice and is guided by the tongue 1638 until the expandable internal channel 1640 emerges through the channel gap 1635.
  • the expandable internal channel 1640 may be located external to the wire connection member 1630 such that it is not threaded through the wire connection member 1630. In this configuration, the expandable internal channel 1640 may be located adjacent to the wire connection member 1630.
  • Figures 26 and 27 shows a side view of a surgical system 1600 with part of the wire connection member 1630 cut away.
  • the camera 1660 may have a plurality of camera wires 1662 connected to the camera 1660.
  • the camera wires 1662 provided electricity, data, and/or control commands to the camera 1660.
  • the camera wires 1662 extend through the central orifice of the wire connection member 1630 from the camera 1660 to an opposite end of the surgical system 1600.
  • the wire 1620 may emerge from a wire port 1622 near the bottom of the wire connection member 1630 and connect to the wire connection member 1630 at a top portion of the wire connection member 1630.
  • Figures 28 and 29 shows an actuation device 1700 of the surgical systems described herein.
  • the actuation device 1700 may also be referred to as a control handle.
  • the actuation device 1700 is located at a proximal of a endoscope or a surgical system.
  • the actuation device 1700 includes a top cover 1710 and a bottom cover 1715.
  • the top cover 1710 and bottom cover 1715 arc configured to engage with each other and conceal or mostly conceal the contents of the actuation device 1700.
  • the actuation device 1700 further includes an external port 1720, a wire directing device 1730, and at least one actuator 1740.
  • the external port 1720 is located at the top of the actuation device 1700 and is configured to receive the external feature 1610 or an elongate tubular structure as described herein.
  • the elongate tubular structure include the features of the surgical system 1600 described herein.
  • the external port 1720 includes a knob 1722.
  • the knob 1722 is configured to apply pressure to the external feature 1610 threaded through the external port 1720.
  • turning the knob 1722 in a first direction causes the pressure applied to the external feature 1610 to increase and turning the knob 1722 in a second direction causes the pressure applied to the external feature 1610 to be alleviated.
  • the knob 1722 when the knob 1722 is a position where sufficient pressure is applied to the external feature 1610, the external feature 1610 is prevented from being additionally threaded through the external port 1720, thereby setting the length of the external feature 1610 emerging from the external port 1720.
  • the knob 1722 is in a position where the pressure applied to the external features is below a threshold value, the external feature is permitted to further be threaded through the external port 1720, thereby increasing or decreasing the length of the external feature emerging from the external port 1720.
  • the wire directing device 1730 is connected to the external port 1720 and configured to receive the external feature 1610 threaded through the external port 1720. In some embodiments, only a portion of the external feature 1610 is threaded through the wire directing device 1730. As seen in Figures 28 and 29, the wire directing device includes at least one slot 1732. The at least one slot 1732 is configured to engage with at least one protrusion 1712 of the top or bottom cover 1710 or 1715 and thereby secure the wire directing device 1730 within the top or bottom cover 1710 or 1715.
  • the wire directing device 1730 further includes a separator 1734.
  • the separator 1734 is configured to engage with the external feature 1610 and receive any objects, wires, or tools that are passing through the external feature 1610. As seen in Figure 29, the separator may have three different openings, a left opening 1735, a right opening 1737, and a central opening 1736.
  • the separator 1734 may be configured to direct wires, objects, or tools to any on the openings.
  • the at least one actuator 1740 is configured to receive the objects, tools, or wires extruding from the openings of the separator 1734.
  • a first actuator is configured to engage with an object, tool, or wire emerging from the left opening 1735 of the separator 1734.
  • a second actuator is configured to engage with an object, tool, or wire emerging from the right opening 1737 of the separator 1734.
  • the actuators 1740 are configured such that a user may interact with the actuators 1740 and thereby control various aspects of the surgical system.
  • the wire 1620 may be threaded through an opening of the wire directing device 1730 and attached to the actuator 1740.
  • a user may cause the wire 1620 to be pulled or may increase the tension on the wire 1620, thereby causing the wire connection member 1630 to bend at the other end of the surgical system or endoscope.
  • the actuator 1740 may be further connected to another device, such as but not limited to, a water source, a power source or controller.
  • the wire, objects, or tools may be threaded through the actuator and engage with the device connected to the actuator 1740.
  • a user is able to control the objects, wires or tools threaded through the actuator 1740 by interacting with the device.
  • the present disclosure provides, inter alia, a single-use or disposable, low- cost, electronic endoscope with a variable profile distal tip, having an articulating interior structure to facilitate guidance and aiming for surgical procedures.
  • the technology encompasses various forms similar to and different from the specific modes for implementing the inventions (also called “embodiments") described herein.
  • the described endoscopes are intended to provide a description of some possible forms of the technology, are not intended as a comprehensive disclosure of the full scope or all features and permutations encompassed hereby, and do not limit the scope of any accompanying claims.
  • the ratio of the length of the endoscope portion with the expandable or elastomeric working channel to the outer diameter of the insertion portion ranges from about 5:1 to about 1:1, and preferably is less than about 4:1, and most preferably less than about 2:1.
  • the expandable working channel assumes the enlarged-profile without moving the image sensor relative to the light transmission system.
  • the expandable distal tip can have an elastomeric sheath, which assumes a generally noncircular cross-sectional shape when either the working channel or the flushing lumen is enlarged.
  • the camera moves slightly in one direction while the tip expands to allow a tool to pass. Once the tool emerges and expansion is done, the camera can be repositioned. Having passed the camera, the tool can be pushed forward or back with a range of motion that does not cause further camera movement.
  • the expandable outer sheath, the flushing lumen and the variable profile working channel can be made from various sterilizable, biocompatible polymeric materials. Each can be made from materials having biocompatible elastomeric tubing, which can be the same materials or different materials.
  • the flushing lumen and the variable profile working channel can also be made from biocompatible non-elastomeric materials.
  • the enlarged working channel is capable of accommodating passage of a tool having a circular cross-sectional shape with a diameter equal to at least 50% of the outer diameter of an insertion portion, preferably equal to at least 60% of such an insertion portion, and most preferably equal to at least 95% of an insertion portion.
  • the outer sheath assumes a generally noncircular cross-sectional shape.
  • the described electronic endoscopes are useful for various operative or therapeutic procedures (e.g., arthroscopy, gall stone intervention, gynecologic endoscopy, kidney stone intervention, otolaryngologic endoscopy, and urologic endoscopy).
  • the endoscopes described in this disclosure can also be used for many additional applications, including arthroscopic joint examination and surgery for hands, shoulders and knees, as well as for biliary (relating to the liver), airway, ear/nose/throat, pulmonary, and vascular surgeries.
  • the described devices are useful for general surgical uses.
  • Such disposable endoscopes do not need re-sterilization, and can provide good visualization in a relatively small package, because the portion of the endoscope inserted into the patient has an outer diameter of about 2 mm or less. This facilitates therapeutic endoscopic use by general practice doctors in their offices on an outpatient basis and avoids delays and costs associated with scheduling procedures to occur in hospital operating rooms.
  • the electronic endoscope can have a hub, which remains outside the patient's body.
  • the hub is used by the doctor to manipulate the endoscope.
  • An elongated, flexible shaft extends from that hub. This is the portion of the endoscope, that can be inserted into the patient's body.
  • An expandable tip extends from the end of the shaft that is farthest away from the hub. This is the distal tip.
  • This expandable distal tip has sensors that allow the doctor to see inside the patient's body and a working channel, which allows the doctor to treat or operate on nearby structures.
  • CMOS complementary metal oxide semiconductor
  • the distal tip can have a variable profile working channel.
  • the working channel permits one or more tools (e.g., ablation devices, cannulas, dissectors, electrodes, forceps, graspers, knot pushers, laser fibers, needle holders, suction and irrigation instruments, trocars, and other tools) to be passed within the endoscope from the hub to the image sensor's forward field of view.
  • the variable profile working channel can change shape to allow the tools to pass alongside the image sensor.
  • the expandable working channel can change from a generally noncircular cross-sectional shape to a different and enlarged cross- sectional shape which permits tools to pass.
  • Some endoscopes have a hub that encloses a light source. The doctor uses the hub to manipulate the endoscope.
  • An insertion portion extends from the hub. At the distal tip of the endoscope (furthest from the hub), the insertion portion has an expandable outer sheath.
  • a light transmission system conveys light from the hub and onto a subject to be illuminated beyond the distal tip.
  • An image sensor is positioned at approximately the center of the endoscope's distal tip. The sensor picks up an image of the illuminated subject.
  • a variable profile working channel can extend from the hub to the distal tip of the endoscope. The working channel is positioned inside the expandable outer sheath.
  • a low-profile configuration of the working channel fits within a space defined between the image sensor and the expandable outer sheath.
  • An enlarged-profile configuration of the working channel permits tools to travel past the image sensor and out of the distal tip.
  • the expandable outer sheath has a generally noncircular shape at the distal tip.
  • Some endoscopes have a proximal end closest the doctor, a distal end at the opposite end and a field of view at that distal end.
  • the hub is at the proximal end.
  • the portion of the endoscope which extends from the hub towards the distal end can be termed the "insertion portion.”
  • the hub remains outside the patient.
  • An expandable distal tip extends from the insertion portion to the distal end and has a sensor configured to pick up an image within the field of view.
  • a working channel, a flushing lumen, and a light-guide (e.g., one or more optical fibers) extend within the insertion portion from the hub to the distal end.
  • the endoscope has a cross-section, which includes the flushing lumen, the light-guide, a generally circular cross-section of the working channel, and a cable extending from the sensor to the hub.
  • the endoscope has a different cross-section. That different cross-section has the image sensor, the working channel, the flushing lumen, and the light-guide. Both the working channel and the flushing lumen are capable of changing their profiles, and are capable of doing so independently of one another. Each can assume a generally noncircular, low-profile configuration. Each can also assume an enlarged-profile to accommodate a tool passing through the working channel or to accommodate liquid passing through the flushing lumen.
  • the endoscopes described briefly here have expandable distal tips, a variable profile working channel and, optionally, an expandable secondary lumen (e.g., for flushing).
  • the materials from which these three structures are made can be the same or different.
  • Biocompatible elastomeric material can be used to make all three structures (e.g., silicone rubber, thermoplastic elastomer (TPE)).
  • TPEs include copolyester elastomers (e.g., ARNITEL® from DSM), polyether block amide (e.g., PEBAX® from Arkema), polyether polyester block copolymers (e.g., HYTREL® from Du Pont), polyolefin elastomers (e.g., ENGAGE® from Dow Chemical), polyurethane elastomer (e.g., PELLETHANE® from Dow Chemical), styrene block copolymers (e.g., EVOPRENE® from AlphaGary), styrenebutadiene block copolymers (e.g., STYROFLEX® from BASF), styrene-ethylene-butylene- styrene block copolymers (e.g., KRATON® from Kraton Polymers), and thermoplastic vulcanizates (e.g., SANTOPRENE® and GEOLAST® from ExxonMo
  • the working channel and the optional flushing lumen also can be made from non-clastomcric materials, which can change from a low-profile configuration to an enlarged-profile configuration (e.g., poly(ethylene-vinyl acetate) (PEVA), polyimide, polytetrafluoroethylene (PTFE), or polyvinyl chloride (PVC)).
  • PEVA poly(ethylene-vinyl acetate)
  • PTFE polytetrafluoroethylene
  • PVC polyvinyl chloride
  • Interior channels can have a low-profile configuration.
  • the low-profile working channel of a 2 mm endoscope can have a 0.5 mm diameter within the shaft and then assumes a more compact configuration within the distal tip so that it fits the space between the expandable outer cover, the articulated tip, and the camera.
  • a low-profile working channel can have a generally lunate cross-sectional shape. The ends of the lunate cross-sectional shape can be rounded or bent more sharply. Other shapes are possible, including circular, reniform, oblong, oval, etc.
  • Interior channels can also have an enlarged-profile configuration to allow tools to pass the camera, as guided by an articulated tip.
  • the enlarged-profile working channel of a 2 mm endoscope can be large enough to allow tools with an outer diameter of approximately 1.2 mm to pass through it.
  • Channels within a shaft can be made from non-elastomeric polymeric materials (e.g., poly(ethylene-vinyl acetate) (PEVA), polyimide, polytetrafluoroethylene (PTFE), polyvinyl chloride (PVC)) or from biocompatible elastomeric tubing (e.g., latex rubber, silicone rubber, or various USP Class 6 compatible TPEs).
  • PEVA poly(ethylene-vinyl acetate)
  • PTFE polytetrafluoroethylene
  • PVC polyvinyl chloride
  • biocompatible elastomeric tubing e.g., latex rubber, silicone rubber, or various USP Class 6 compatible TPEs.
  • Flushing fluid can pass through a secondary channel, which can be referred to in this case as a flushing channel.
  • a flushing channel can have any cross-sectional shape within the shaft 3 so long as sufficient fluid can be passed.
  • Channels can be made from a single length of elastomeric tubing.
  • the proximal portion of flushing channel within the shaft can be made from non-elastomeric material (e.g., a polyimide tube) and coupled to an elastomeric tip section.
  • a secondary channel can be used for a stylet.
  • a stylet channel can allow introduction into the endoscope of a stylet (not shown), which is a slender probe, typically made from a metal. When the stylet is introduced, it provides additional stiffness. This can facilitate proper positioning of the endoscope's distal tip within the patient.
  • the stylet can impart a particular shape to the endoscope (e.g., a particular curve or bend).
  • the stylet channel should resist puncture by the stylet tip. Reinforcement is optional.
  • This stylet channel can be made from various polymeric tubing materials, such as PEV A, polyimide, PTFE, or PVC.
  • the stylet channel 27 is shown to have a circular profile, but can have any profile that allows the stylet to pass through it.
  • a stylet channel can have thin-wall tubing similar’ to that described previously for other working channels such as polyimide, PTFE, or other tubing.
  • Such a channel can have a durable stop at its distal tip, such as a plug of hard plastic such as acrylic, ABS, or other material bondable or mechanically securable to the stylet channel, which is intended to prevent the stylet from puncturing or damaging other components.
  • the tubing also can be crimped or folded over at the end to create a stop if the tip of the stylet is rounded. This can be in addition to the hard plastic plug or instead of it.
  • a control wire is included, such as the pull wire 1013 of Figure 10. Such a feature may have its own channel, or it can be included during the manufacturing process and therefore not need a separate channel for later introduction to a surgical site.
  • a control wire can fulfill the same or a similar function to that described above for a stylet.
  • a coupling sleeve may be used to join these portions.
  • a circular cross-section working channel shaft and expandable working channel are made from different materials or different sections of tubing that are affixed together. If these are made using a single length of tubing, a coupling sleeve may not be used.
  • a working channel coupling sleeve can fit on the outside of a joint between a circular crosssection working channel shaft and an expandable working channel portion to preserve a consistent inner diameter for tool insertion and removal.
  • the coupling sleeve can be a short piece of thin-wall polymeric tubing (e.g., a 4-5 mm of 0.0.254 mm wall thickness polyimide tubing, which is obtainable from Putnam Plastics or Vention Medical).
  • the articulating tips described herein can perform supporting, guiding, protecting, and other functions. They can be strong and resilient, such that pulling on a control wire can cause them to flex in a reproducible way without failing. In some embodiments, the tips can strongly resist bending beyond a point from which they cannot elastically return to an original shape or configuration. For example, this can occur when ribs come in contact, thereby supporting the spine portion and preventing further bending in a given direction.
  • An articulating tip can be formed from sintered materials such as Ti-6AL- 4V, and/or similar substances. Articulating tips can have the structure, dimensions, and features of the articulating tips illustrated in Figures 1-14.
  • Interior support structures such as those described in this application can have multiple roles and benefits. Each of these can be enhanced using materials or combinations of materials.
  • an articulating tip can be constructed from material having strength and rigidity to perform its support and guidance functions. Titanium, stainless steel, and similar materials can provide such properties (e.g., Ti-6AL-4V). Stainless steel may also provide strength and rigidity for the purposes described here.
  • an access device such as an endoscope can include one or more portions that are radiopaque, or that block radiation of the relevant kind.
  • an articulating tip such as that described in Figures 1-14 can be formed from radiopaque material, and thus be visible using X-ray microscopy during a surgical procedure.
  • This external view can be combined with an internal view (that is, the view from the tiny internal camera positioned at the end of the articulating tip) to allow a surgeon to also visualize interior conditions in the immediate surgical target zone.
  • a control wire can be radiopaque or have a portion thereof that is radiopaque.
  • an enlarged tip 1011 can be radiopaque. This can result from a welding process, for example, when a welding material is used to secure a control wire to distal end of an articulating structure. If that welding material is more radiopaque than the other materials, it can form a locatable mass of material that aids in surgical control and awareness. If a surgeon knows that this mass is located at a known distance behind the leading edge (e.g., a camera) of an endoscope, they can account for this offset.
  • a control wire can be fully radiopaque (e.g., if formed from stainless steel piano wire), but can be less visible in x- rays than a bulbous end thereof.
  • a laser welding process can be used to weld a stainless steel control wire to a titanium or other rigid material forming the articulated tip, for example.
  • a platinum material (which can be denser than gold) can be radiopaque and can be used to form some or all of an articulated tip, or can be connected or fused thereto.
  • a platinum coating, ring or band can be added to the proximal or distal end of an endo skeleton structure.
  • one or multiple radiopaque sections can be formed in or on an articulating tip.
  • a radiopaque coating can be applied.
  • Multiple radiopaque portions or markings can work together to provide a surgeon with information about orientation as well as position of a surgical device or endoscope.
  • an elongate structure such as an articulating tip illustrated in Figures 1-14 can have a radiopaque portion at the front and the back. If an x-ray shows that the two portions are spaced as expected, the device is oriented approximately parallel to the x-ray machine.
  • the x-ray machine may be oriented more to the front or the back (such that the device is pointing into or out of the patient, from the perspective of the x-ray machine, for example).
  • a radiopaque portion may have a directional shape such as an arrow, so that the surgeon can tell which way the endoscope is facing.
  • two radiopaque portions e.g., a leading marker and a trailing marker
  • a laser can be in the illumination position (see, e.g., the fiber optic tip labeled 1266 in Figure 12) or similarly configured to aim in the same direction as the camera.
  • Lasers can be used to cut or ablate tissue, remove unwanted material, open passages, etc.
  • Lasers can be used for ablating portions of vocal chords, stone lithotripsy (breaking up stones in the kidney or parts of the ureter), removal, shaping, or cutting of material in the spine (e.g., bulging discs), and similar procedures.
  • ultrasound can also be used for intervention.
  • ultrasound can be used to activate drugs.
  • Ultrasound can also be used to perform some of the functions described for lasers (although potentially more slowly and gently), such as removal of unwanted tissue, opening passages, etc.
  • laser and ultrasound can be used together or in similar roles, and can be incorporated into an endoscope, either as part of the main endoscope device, or as a surgical instrument that passes through one or more working channels.
  • one or more of these technologies can also be used from outside (such as when ultrasound is used for visualization with or as a replacement for x-ray techniques).
  • An ablation device such as a laser can be especially useful when combined with the disclosed articulating tip because the control wire can help position and aim both the camera and a laser tip, for example.
  • a combination of twisting the endoscope around its elongate axis and pulling on the control wire can cause the articulated tip to arch or bend, which in turn points or aims the camera and laser in a desired lateral direction.
  • the directionality and fine control enabled by the articulated tip can be particularly beneficial for laser and similar aimed techniques, ablative or otherwise.
  • Operational arthroscopic procedures can have life-threatening risks.
  • General anesthesia with its attendant risks, can be used, particularly for more interventional operative arthroscopy.
  • doctors can use sterile techniques and equipment.
  • Such risks are not trivial.
  • the Ronald Reagan UCLA Medical Center is a leader in performing the latest minimally invasive endoscopic procedures. In February 2015, as many as 179 people at that hospital were exposed to drug-resistant bacteria while undergoing endoscopic procedures. According to press reports, seven of those people become infected with methicillin-resistant staphylococcus aureus (MRSA), and two of those patients died.
  • MRSA methicillin-resistant staphylococcus aureus
  • a single-use endoscope sterilization by the original manufacturer can be done in bulk (e.g., using ethylene oxide gas, gamma radiation, steam).
  • a single-use device can have tubing connections that butt against one another but still allow a small crack, gap, or void at the joint.
  • Materials suitable for the bulk sterilization such as by ethylene oxide gas, can also be used to construct the endoscope without concern for the materials having to be compatible with multiple exposure to sterilization chemicals such as glutaraldehyde.
  • Coatings can be applied to the outside of the endoscope.
  • coatings could provide anti-bacterial or anti-microbial properties (e.g., copper ions, silver ions). Coatings can also be used to allow doctors to detect certain conditions. For example, special peptides and other formulations can be applied that detect presence of bacterial contamination or biomarkers of other sorts.
  • a UV-cured adhesive potting compound is applied at the distal tip and flows between the components, while it is viscous. Excess potting compound is removed and UV light applied to cure or harden the material. Other materials can also be used, such as 2-part epoxies. Application of the potting compounds may be limited to areas that do not interfere with the expandable distal tip sections (e.g., by fixtures that limit the distribution area of the compound), and/ or use materials that do not bond to those expandable sections.
  • An endoscope can use a CMOS color camera, which is biocompatible and waterproof.
  • the camera provides a field of view external from the endoscope.
  • a forward field of view would look beyond the distal tip of the endoscope.
  • the field of view can also be at an angle external from the endoscope (e.g., an off-angle-looking endoscope such as 30°).
  • the CMOS image sensor includes a multi-element lens assembly or gradient refractive index (GRIN) lens providing a field of view of 30-180°, preferably of 50-130°, and most preferably 60-120°.
  • GRIN gradient refractive index
  • the effective image resolution preferably is at least 10,000 pixels, more preferably at least 40,000 pixels, and most preferably at least 60,000 pixels, although image resolutions of 1 megapixel or greater are possible.
  • Other sensors can be used instead of or in conjunction with the CMOS device so long as they provide sufficient image resolution.
  • a charge-coupled device CCD could be used.
  • an optical prism can be added to modify the particular angular view of the image sensor.
  • the prism has a reflective surface that "tilts" the viewing cone of the image sensor by a predetermined amount, such as 30°, 70°, etc.
  • the prism may be made of glass or any clear polymer, such as acrylic or polycarbonate.
  • the prism could be bonded using optically-clear epoxy to the flat distal surface of the camera. More preferably, the prism could replace the final camera lens in the original manufacture of the device.
  • the camera sensor can be further affixed to the structure of the endoscope.
  • the camera sensor can be affixed directly to the light guide to provide additional support.
  • the camera cable can be adhered to the sheath cover, the working channel, or both.
  • the camera cable can be bonded to the inside of the sheath cover, just proximal to the expandable distal tip section. These further connections provide added stiffness.
  • An endoscope can use an LED surface-mounted chip with the proximal ends of the illumination fibers placed Hush against the light emitting surface area of LED (e.g., within a hub or other proximal portion).
  • Non-LED illumination sources can be used (e.g., halogen incandescent, xenon light, diode lasers) so long as the particular illumination chosen can be picked up by the camera or sensor.
  • An epoxy can provide a secure attachment, although other methods can be appropriate.
  • PCA circuitry can control illumination intensity of the light source and operate the camera.
  • PCA circuits can translate signals to and from an external control/display. These circuits convert signals into the patterns, voltages, timing, etc., needed by, or sent from the camera and used for the illumination source. Such translation can include converting the signals into a Universal Serial Bus (USB) standard.
  • USB Universal Serial Bus
  • Multi-layer or stacked multi-layer circuits with embedded software (e.g., firmware) and Field Programmable Logic Arrays (FPGAs) translate and communicate the signals.
  • a PCA can include a wireless transceiver and a power source (e.g., battery).
  • the battery can powers a PCA and an image sensor.
  • a wireless transceiver can interface with external control and display devices. For example, a PCA can wirelessly transmit image signals from an image sensor to an external display.
  • signal translation can be accomplished externally of the endoscope.
  • a PCA may function as an interconnection and route signals to a cable, which then connects to an external control/display unit.
  • LEDs and illumination fibers or fiber bundles can be arranged to assure sufficient illumination intensity to achieve the desired field of view and depth of field.
  • An LED if small enough, can be mounted adjacent to the camera within the expandable tip section.
  • Illumination fibers can be routed from the LED to reach the outside of the camera at the distal tip.
  • Such an illumination subassembly can be rigid.
  • the illumination subassembly can be varied, so long as it provides sufficient illumination intensity to achieve the desired field of view and depth of field.
  • a shaped light guide can be used to replace optical illumination fibers, as long as the Numerical Aperture and illumination field pattern of the light emitted from the light guide is compatible with the field of view of the camera.
  • the LED can be mounted within the shaft section or can be exterior to the endoscope, instead of within the hub enclosure.
  • a 2 mm endoscope with expandable working channel and an LED light source in the hub is formed as described below.
  • Two injection-molded ABS pieces 6, 7 (available from Dow Chemical) form the hub enclosure.
  • PCA is a small, multi-layer printed circuit board with surface mount integrated circuits to convert USB signals and communications to/from the camera into the signal levels and timing required by the camera specifications.
  • the PCA is affixed to the proximal hub enclosure using four screws.
  • the proximal hub enclosure has an opening for the working channel.
  • a working channel connector provides a fluid tight seal between the proximal hub enclosure and the working channel. Insert connector (a commercially available LUER-LOK® lock component) into the proximal hub enclosure.
  • the sheath cover is a 29.2 cm length of braided stainless steel reinforced polyimide tubing (Putnam Plastics catalog number 142-0045; 1.88 mm OD, 1.689 mm ID).
  • the distal strain relief tube is an injection molded component made of Shore A 60 TPE. Insert this tube through an opening in hub enclosure. Slide the sheath cover through the distal strain relief for access to the interior of the hub enclosure. Solvent bond with cyclohexanone to affix the sheath cover to distal strain relief tube.
  • the outer sheath is formed from the polyimide and silicone tubing using a manufacturing mandrel.
  • the working channel is also formed using a mandrel.
  • the camera is a micro ScoutCamTM 1.2 (Medigus, Ltd. of Omer, Israel). This camera is cylindrical in shape and measures 1.2 mm in diameter by 5 mm in length, and provides an effective image resolution of about 44,880 pixels.
  • Camera cable 29 extends from camera, runs within the cover assembly but along the outside of the assembled working channel, and connects to PCA 61 at the camera connector. PCA 61 controls camera and receives images from it.
  • Three optical illumination fibers (outer diameter of 0.25mm, from LightHouse LEDs as catalog number 0.25MMFIBERENDGLOW) also run within the cover assembly along the outside of the working channel assembly until they are adjacent to the camera. Adhere proximal ends of the illumination fibers 25 onto the light source, a Luxeon® C power LED (available from the Philips Lumileds Lighting Company) with UV-cured adhesive (208-CTH-F adhesive available from Dymax Corp.).
  • This provides an endoscope with a 30 cm working length, a 2 mm OD, and variable profile distal tip and working channel.
  • Such an endoscope can be used for a variety of endoscopic applications including arthroscopic joint examination and surgery for hands, shoulders, knees, etc.
  • the endoscopes described in this disclosure can be used for many other applications, including orthopedic, biliary (relating to the liver), airway, urologic, ear/nose/throat, pulmonary, vascular, etc. Indeed, the described devices are useful for general surgical uses.
  • An endoscope similar to that described in Example 1 is formed with a variable profile flushing lumen in addition to the variable profile working channel.
  • a 30 cm length of TPE tubing (Vention Medical PEBAX® tubing catalog number 115-1289; 0.0.279 mm ID, 0.1143 mm wall thickness, 0.51 mm OD, Shore A 63) forms the flushing lumen.
  • the process for making the endoscope is similar to Example 1. Differences are discussed below.
  • the flushing lumen is made from a non-expandable material. Instead of PEBAX® tubing, the flushing lumen is made from polyimide tubing (Vention Medical catalog number 141-0023; 0.508 mm OD, 0.457 mm ID).
  • the flushing lumen is manufactured to provide that feature.
  • the creased and flattened distal tip of the flushing lumen expands as fluid passes within the flushing lumen. This, in turn, expands the outer cover.
  • n endoscope similar to that described in Example 1 is configured for wireless communication with an external display and a control device (e.g., a PC or tablet computer).
  • the PC A has wireless transmitting and receiving components.
  • Commonly available button-style batteries are included within the hub assembly to power PCA.
  • An antenna wire is included and attached to the PCA. Connect a switch in series with the battery. The batteries provide sufficient power to allow the endoscope system to function for several hours.
  • An endoscope similar to that described in Example 1 except the expandable working channel is a 30 cm length of non-reinforced polyimide tubing (Vention Medical catalog number 141-0083, 1.283 mm OD x 1.219 mm ID). As described in Example 3 above, heat press an 8 mm length of the polyimide tubing at the distal end to form creases and a flattened end. This enables the polyimide tubing to curve around camera inside the expandable outer cover. When a tool or other item is forced through the working channel, the creased and flattened distal tip will expand, in-tum expanding the outer cover, to the extent needed to allow the tool or other item to pass through.
  • Vention Medical catalog number 141-0083, 1.283 mm OD x 1.219 mm ID As described in Example 3 above, heat press an 8 mm length of the polyimide tubing at the distal end to form creases and a flattened end. This enables the polyimide tubing to curve around camera inside the
  • the camera is an Awaiba NanEye camera (available from AWAIBA Lda). This camera measures 1.1 mm x 1.1 mm x 1.7 mm long with a diagonal measurement of 1.41 mm, and provides an effective image resolution of about 62,500 pixels.
  • FIG. 2c shows a cross-sectional view of this endoscope at the distal tip.
  • the outer sheath is formed from a 29.2 cm length of a braided stainless steel reinforced polyimide tubing (1.72 mm OD, 1.57 mm ID, available from Vention Medical catalog 142-0042), an 8 mm length of silicone rubber tubing with an ID of about 1.689 mm, and a thin-walled polyimide coupling tube with an OD of about 1.689 mm.
  • the working channel is formed from thin-wall polyurethane tubing (Vention Medical catalog number 115-0565; 1.346 mm OD, 0.089 mm wall, 1.168 mm ID).
  • the camera is the NanEye camera described above in Example 5.
  • the illumination light guides optical fibers
  • the four-conductor cable from the NanEye camera is connected to PCA for signal connection to a cable suitable for external use and possible signal processing circuits are included on PCA to convert the signals to USB standards or other desired configuration.
  • PCA has memory containing calibration information for the specific NanEyc camera being used.
  • An endoscope hybrid tip comprising: an expandable interior channel; an endoskeleton having: an elongate backbone; at least two ribs extending therefrom; and a groove passage adjacent the backbone and ribs and configured allow passage of at least one expandable channel therethrough; and a resilient exterior layer configured to surround the endoskeleton and the expandable interior channel; the expandable interior channel, endoskeleton, and resilient exterior layer configured such that when a surgical implement passes through the expandable interior channel, the instrument pushes against the endoskeleton and outwardly expands both the expandable interior channel and the resilient exterior layer, thereby bypassing the endoskeleton to reach a surgery location beyond the endoscope.
  • Clause 2 The endoscope hybrid tip of Clause 1, wherein the endoskeleton has at least three ribs extending from the elongate backbone at proximal, intermediate, and distal rib attachment positions, and the elongate backbone has at least two bendable sections located between the rib attachment positions.
  • Clause 3 The endoscope hybrid tip of Clause 2, wherein two of the three ribs are configured to allow the expandable channel and any surgical implement extending therethrough to pass adjacent to the at least two ribs without changing trajectory, and a third rib is configured to direct the expandable channel and any surgical implement extending therethrough to change trajectory.
  • Clause 4 The endoscope hybrid tip of Clause 3, wherein the third rib has an interior space configured to surround and support a camera and a light source, and when the third rib structure directs the expandable channel and any surgical implement extending therethrough to change trajectory, the expandable channel and any surgical implement extending therethrough bypass the camera and light source and the surgical implement extends out into the field of view of the camera.
  • Clause 5 The endoscope hybrid tip of Clause 1, wherein the ribs each include a passage for a control wire.
  • Clause 6 The endoscope hybrid tip of Clause 5, wherein one of the ribs is a distal rib and comprises a control wire engagement portion at a distal terminus of the passage, configured to firmly engage with a portion of the control wire, such that when the control wire is pulled proximally, the ribs approach each other and the elongate backbone bends.
  • Clause 7 The endoscope hybrid tip of Clause 6, further comprising a camera adjacent the distal rib and mechanically coupled thereto such that bending of the elongate backbone aims the camera in a lateral direction.
  • Clause 8 The endoscope hybrid tip of Clause 7, further comprising a laser that is aimable using the control wire such that it can ablate or illuminate tissue in the field of view of the camera.
  • An endoscopic surgery system comprising: an endoscope having a hub, a shaft having an elongate axis and a lateral width, and a working tip at a distal end of the shaft; an energy source configured to provide optical energy through a fiberoptic cable that extends through the shaft to the working tip; a working channel extending continuously from the hub through the shaft to the tip; a camera system comprising a connector cable in the shaft and a camera box at the working tip; a resilient layer at an exterior of the working tip; and a support structure at an interior of the working tip and configured to: position the camera box and an emitting portion of the energy source to both face distally outward from the working tip toward a working zone; and facilitate passage of surgical tools through the working channel at the tip by using a series of hard surfaces to laterally displace a leading edge of any such tools such that the leading edge thereof bypass the camera box, laterally stretch the resilient layer, and protrude from the working channel into the working zone.
  • the support structure comprises an articulated rigid structure having: an elongate back generally aligned with the elongate axis of the shaft; a proximal appendage supported by the back and configured to allow each of the following to extend longitudinally thereby: the fiberoptic cable, the working channel, and the camera system's connector cable; a central appendage supported by the back and configured to allow each of the following to extend longitudinally thereby: the fiberoptic cable, the working channel, and the camera system's connector cable; and a distal appendage supported by the back and configured to aim the camera box and the emitting portion of the energy source toward the working zone.
  • Clause 11 The system of Clause 10, wherein the distal appendage comprises a camera holder and a deflector configured to act as one or more of the hard surfaces.
  • Clause 13 The system of Clause 12, wherein the elongate back has at least two flexion zones and the distal appendage is configured to physically interface with a pull cable at a position laterally offset from a central axis thereof.
  • each of the three appendages provides a passage for the pull cable such that when the pull cable is pulled, the elongate back flexes, the distal appendage approaches the central appendage, and the distal appendage causes the camera box and the emitting portion of the energy source to aim toward a portion of the working zone that is toward the same side as the laterally offset position.
  • a method of introducing and aiming a camera, energy source, and surgical tool comprising: providing an elongate shaft configured to extend to a surgical site; positioning a camera, an energy source, and an articulated support structure at the surgical end of the elongate shaft; providing a resilient sleeve in a generally cylindrical space around the strong support structure; passing an elongate surgical tool having a stiff leading portion through the elongate shaft such that the leading portion passes within the resilient sleeve and adjacent to the articulated support structure, which displaces the leading portion laterally such that it stretches the resilient sleeve, bypasses the camera and energy source, and extends into a field of view of the camera and energy source.
  • Clause 16 The method of Clause 15, further comprising providing an elongate control device that physically interfaces with the articulated support structure to change an aiming direction of the camera and energy source.
  • Clause 17 The method of Clause 16, wherein the control device is a pull wire configured to seat against a distal end of the articulated support structure and pass longitudinally therethrough, extending through the elongate shaft away from the surgical site, and the method further comprises pulling on the pull wire to thereby change the aiming direction.
  • the control device is a pull wire configured to seat against a distal end of the articulated support structure and pass longitudinally therethrough, extending through the elongate shaft away from the surgical site, and the method further comprises pulling on the pull wire to thereby change the aiming direction.
  • Clause 18 The method of Clause 15, further comprising providing a laser as the energy source, using the laser to energize tissue at the surgical site, passing optical information from the camera back through the elongate shaft, and controlling an aiming direction of the camera and laser simultaneously from a proximal end of the shaft.
  • Clause 20 The method of Clause 15, further comprising providing a continuous working channel that extends through the elongate shaft and through the resilient sleeve at the articulated support structure, and passing the elongate surgical tool through the elongate shaft comprises passing the tool through the continuous working channel.
  • a surgical endoscopic system correlating optical feedback and mechanical control comprising: an elongate tip control structure having a proximal end and distal end, a control wire extending therethrough and connected to the distal end, and an aiming direction aligned with an elongate axis of the elongate tip and directed past the distal end; a camera at the distal end of the tip control structure and configured to aim in the aiming direction; at least one surgical implement configured to aim or extend from the distal end; and an expandable sheath configured to tubularly surround the elongate tip and the camera; the control wire configured to cause the elongate tip to arch, thereby causing the aiming direction to move laterally from an initial, relaxed aiming direction.
  • Clause 22 The system of Clause 21, wherein the elongate tip control structure has at least three segments, proximal, middle, and distal, each comprising a passage for the control wire, wherein the middle segment’s control wire passage provides greater lateral space than the distal segment’s passage provides for the control wire.
  • Clause 23 The system of Clause 21, wherein the surgical implement comprises a working channel that is also configured to aim in the aiming direction.
  • Clause 24 The system of Clause 21 , further comprising at least one working channel that can expand adjacent the elongate tip control structure and within the expandable sheath, thereby causing the expandable sheath to expand.
  • Clause 25 The system of Clause 21, wherein the elongate tip control structure has at least one radiopaque portion configured for visibility under radiation external to a patient.
  • Clause 26 The system of Clause 25, wherein the radiopaque portion comprises one or more of the control wire and an enlarged mass at the end of the control wire formed from a dense metal material.
  • Clause 27 The system of Clause 21, wherein the surgical implement comprises a laser configured to aim in the aiming direction.
  • Clause 28 The system of Clause 21, wherein the elongate tip control structure further comprises one or more radiopaque features formed from a different material from and associated with the elongate tip control structure such that visualization from radiation external to a patient can demonstrate an orientation of the elongate tip control structure.
  • An endoscope hybrid tip comprising: a wire connection member with a maximum width; a wire attached to the wire connection member; an expandable interior channel configured to expand beyond the maximum width of the wire connection member; and a resilient sheath configured to surround the wire connection member and the expandable interior channel, the resilient sheath configured to expand to accommodate the expansion of the expandable interior channel.
  • Clause 30 The endoscope hybrid tip of clause 29 wherein the wire connection member is configured to interact with at least one rigid structure within the tip such that the wire can cause the tip to change an angle of direction of the tip.
  • Clause 31 The endoscope hybrid tip of clause 30 wherein the at least one rigid structure comprises an elongated spine.
  • Clause 32 The endoscope hybrid tip of clause 30 wherein the at least one rigid structure comprises a camera or a light source.
  • Clause 33 The endoscope hybrid tip of clause 29 wherein the wire connection member is a ring.
  • Clause 34 The endoscope hybrid tip of clause 29, wherein the wire connection member is a camera.
  • a steerable endoscope comprising: a control handle located at a proximal end of an endoscope and comprising a tension wire handle configured to increase tension on an elongate wire that extends from the control handle; an elongate tubular structure extending from the control handle and having a central axis; a working tip located at the distal end of the elongate tubular structure and comprising a rigid body attached to a distal end of the elongate wire at an attachment position that is offset from the central axis; the elongate tubular structure configured to expand outwardly at the working tip to accommodate passage of a surgical apparatus therethrough as the apparatus passes by other rigid structure contained within the working tip; a working channel extending within and through the elongate tubular structure and configured to expand at the same position and time as the outward expansion of the tip of the elongate tubular structure; the working tip having sufficient rigidity to change direction and resist kinks when tension is increased on the tension wire, the working tip also
  • Clause 36 The endoscope of clause 35, wherein the working tip comprises at least two rigid articulating members within the elongate tubular structure, configured to extend at least partially around the central axis, and having at least one side opening to accommodate passage of the surgical apparatus and expansion of the working channel.
  • Clause 37 The endoscope of clause 35, wherein the working tip comprises a rigid ring surrounding a camera module, the rigid ring comprises the attachment position, and the elongate tubular structure and contents thereof at the working tip provide sufficient rigidity to resist kinking when tension on the wire causes the working tip to change direction.
  • Clause 38 The endoscope of clause 35, wherein the working tip comprises a rigid skeleton having a series of rib components separated by bilateral openings.
  • Clause 40 The endoscope of clause 39, wherein the rigid skeleton has at least one lateral opening adjacent a camera.
  • Clause 41 The endoscope of clause 40, wherein the lateral opening is configured to allow the surgical apparatus to expand the working channel such that it bulges out through that lateral opening to bypass the camera.
  • 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.

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Abstract

Un système de chirurgie endoscopique peut comprendre un endoscope comportant un moyeu, un arbre et une pointe de travail. Une source d'énergie peut utiliser un câble à fibre optique et un canal de travail qui s'étendent tous deux à travers l'arbre jusqu'à la pointe. Une caméra au niveau de la pointe de travail peut être entourée par une couche élastique et supportée par une structure de support à l'intérieur de la pointe. La structure peut diriger la caméra et l'énergie vers une zone de travail. La structure peut également faciliter le passage d'outils chirurgicaux dans le canal de travail au-delà de la caméra vers la zone de travail, tandis que la couche élastique s'étire. La structure peut avoir une commande qui facilite la visée de la caméra et du faisceau. La structure peut avoir un cadre de flexion et de multiples éléments qui s'interfacent avec des structures allongées telles que des câbles, des outils et des canaux. Les éléments peuvent avoir des surfaces de guidage pour faciliter le passage d'outils et protéger la caméra. La structure, la couche élastique et d'autres aspects peuvent coopérer pour faciliter l'insertion d'outils à dents, et des tailles micro-endoscopiques pour les chirurgies les plus délicates.
PCT/US2024/026080 2023-04-25 2024-04-24 Structure de pointe et procédés pour procédures endoscopiques Pending WO2024226665A2 (fr)

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US9913570B2 (en) * 2015-08-07 2018-03-13 Enlightenvue Llc Endoscope with variable profile tip
US20180326144A1 (en) * 2017-05-12 2018-11-15 Meditrina, Inc. Endoscope system and method of use
US20220053998A1 (en) * 2019-05-01 2022-02-24 Ambu A/S Devices, systems, and methods for treating kidney stones
DE102020111458A1 (de) * 2020-04-27 2021-10-28 Schölly Fiberoptic GmbH Flexibles Endoskop mit Skelett-Struktur

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