Tip structure and method for endoscopic procedures

Abstract

An endoscopic surgical system may have an endoscope comprising a hub, a shaft, and a working tip. The energy source can be either a fiber optic cable or a working channel, both extending through the shaft to the tip. The camera at the working tip may be surrounded by an elastic layer and supported by a support structure within the tip. This structure can aim the camera and energy towards the working zone. The structure can also facilitate the passage of surgical instruments through the working channel beyond the camera into the working zone while the elastic layer stretches. The structure may have a control unit to facilitate the aiming of the camera and beam. The structure may have a flexible frame and multiple attachments that interface with elongated structures such as cables, instruments, and channels. The attachments may have guide surfaces to facilitate the passage of instruments and protect the camera. The structure, elastic layer, and other aspects work together to facilitate the insertion of tine instruments and the micro-endoscopic sizing suitable for the most delicate surgeries.

Description

Cross - reference to related applications

[0001] This application claims the benefit of priority based on U.S. Provisional Patent Application No. 63 / 498,246, filed on April 25, 2023. Further, any and all such priority applications for which foreign or domestic priority is claimed are hereby incorporated by reference into this specification. The entire contents of each of the above items (and other patent documents referenced herein) are hereby incorporated by reference into this specification and are made a part hereof for all purposes as if fully set forth herein.

Technical Field

[0002] The described technology generally relates to devices and methods for performing surgical procedures within body cavities, cavities, or other enclosed spaces.

Background Art

[0003] Endoscopes are useful for surgical procedures but have various drawbacks addressed in this disclosure. This technology overcomes the drawbacks of conventionally known surgical endoscopes, particularly micro - endoscopes.

Summary of the Invention

[0004] This disclosure describes an endoscopic hybrid tip. The tip may have an expandable internal channel and an endoskeleton. It may have an elongated stem, two ribs extending therefrom, and a groove passage adjacent to the stem and the ribs. The groove passage may be configured to allow at least one expandable channel to pass through. The tip may also have an elastic outer layer configured to surround the endoskeleton and the expandable internal channel. The expandable internal channel, the endoskeleton, and the elastic outer layer may be configured such that when a surgical instrument passes through the expandable internal channel, the instrument pushes against the endoskeleton to expand both the expandable internal channel and the elastic outer layer outwardly, thereby bypassing the endoskeleton and reaching the surgical site beyond the endoscope.

[0005] In some embodiments, the endoskeleton has at least three ribs extending from an elongated base at proximal, intermediate, and distal rib attachment locations, the elongated base having at least two flexible sections located between the rib attachment locations. In some embodiments, two of the three ribs are configured to allow an expandable channel and any surgical instrument extending through it to pass adjacent to at least two ribs without altering its trajectory, and a third rib is configured to guide the expandable channel and any surgical instrument extending through it to alter its trajectory. In some embodiments, the third rib has an internal space configured to surround and support a camera and a light source, and when the third rib structure guides the expandable channel and any surgical instrument extending through it to alter its trajectory, the expandable channel and any surgical instrument extending through it bypass the camera and light source, and the surgical instrument extends into the camera's field of view. Each rib may include a passage for a control wire. In some embodiments, one of the ribs is a distal rib, and at the distal end of the passage, there is a control wire engagement portion configured to firmly engage with a portion of the control wire, so that when the control wire is pulled proximal, the ribs move closer together and the elongated base bends. In some embodiments, a camera is adjacent to the distal rib and can be mechanically connected to the distal rib so that the bending of the elongated base causes the camera to aim laterally. The endoscopic hybrid tip may further include a laser that can be aimed using the control wire so that tissue within the camera's field of view can be excised or illuminated.

[0006] This disclosure further describes an endoscopic surgical system, which may include an endoscope having a hub, a shaft having an elongated axis and width, and a working tip at the distal end of the shaft. The system may have an energy source configured to supply optical energy through an optical fiber cable extending through the shaft to the working tip. The system may also have a camera system comprising a working channel extending continuously from the hub through the shaft to the tip, a connector cable in the shaft, and a camera box at the working tip. The system may have an elastic layer on the outside of the working tip and a support structure inside the working tip. The support structure may be configured to position the camera box and the energy source discharge portion so that both face distally outward from the working tip toward the working zone. The support structure may also be configured to facilitate the passage of surgical instruments through the working channel at the tip by using a series of rigid surfaces to laterally displace the anterior edge of any such instrument so that the anterior edge of the surgical instrument bypasses the camera box, stretches the elastic layer laterally, and protrudes from the working channel into the working zone.

[0007] In some embodiments, the support structure comprises an articulated rigid structure having an elongated dorsal portion substantially aligned with the elongated axis of the shaft, and a proximal appendage supported by the dorsal portion and configured such that each of the fiber optic cables, work channels, and connector cables of the camera system can extend longitudinally thereby. The system may also have a central appendage supported by the dorsal portion and configured such that each of the fiber optic cables, work channels, and connector cables of the camera system can extend longitudinally thereby. The system may also have a distal appendage supported by the dorsal portion and configured to align the camera box and the emission portion of the energy source toward the work zone. The distal appendage may comprise a camera holder and a deflector configured to function as one or more of the rigid surfaces. The support structure may be configured for controlled bending. The elongated dorsal portion may have at least two bending zones, and the distal appendage may be configured to physically interface with the tension cables at a position laterally offset from its central axis. Each of the three attachments can provide a passage for the tension cable, such that when the tension cable is pulled, the elongated back bends, the distal attachment moves closer to the central attachment, and the distal attachment aims at a portion of the work zone on the same side as the camera box and energy source discharge portion, which are laterally offset.

[0008] A method for introducing and aiming a camera, energy source, and surgical instrument is also disclosed. This method may include providing an elongated shaft configured to extend to the surgical site, positioning the camera, energy source, and articulated support structure at the surgical end of the elongated shaft, and providing an elastic sleeve in a substantially cylindrical space around the rigid support structure. The method may further include passing an elongated surgical instrument having a rigid anterior portion through the elongated shaft such that the anterior portion passes within the elastic sleeve adjacent to the articulated support structure, thereby displacing the anterior portion laterally so that the anterior portion stretches the elastic sleeve, bypasses the camera and energy source, and extends within the field of view of the camera and energy source.

[0009] In some embodiments, the method may further include providing an elongated control device that physically interfaces with an articulated support structure to change the aiming direction of a camera and an energy source. The control device may be a tension wire seated at the distal end of the articulated support structure, passing there longitudinally and extending through an elongated shaft away from the surgical site, and the method may include changing the aiming direction by pulling the tension wire. The method may also include providing a laser as an energy source, using the laser to supply energy to the tissue at the surgical site, transmitting optical information from the camera backward through the elongated shaft, and simultaneously controlling the aiming direction of the camera and laser from the proximal end of the shaft. The articulated support structure may comprise a core and three rib sections, with a distal rib section supporting and protecting the camera, more proximal ribs providing rigidity to the surgical end of the elongated shaft, and the ribs collectively providing a pathway for any elongated surgical instrument within an elastic sleeve. A continuous working channel may extend through the elongated shaft and through the elastic sleeve in the articulated support structure. Passing a long, slender surgical instrument through a long, slender shaft may involve passing the instrument through a continuous working channel.

[0010] Several embodiments provide surgical endoscope systems that correlate optical feedback with mechanical control. The system may comprise: an elongated tip control structure having a proximal and distal end, a control wire extending through it and connected to the distal end, and a aiming direction aligned with the elongated axis of the elongated tip and guided beyond the distal end; a camera located at the distal end of the tip control structure and configured to aim in the aiming direction; at least one surgical instrument configured to aim from or extend from the distal end; an expandable sheath configured to enclose the elongated tip and camera in a tubular manner; and a control wire configured to arch the elongated tip, thereby moving the aiming direction laterally from the initial relaxed aiming direction.

[0011] In some embodiments, the elongated tip control structure has at least three segments: proximal, intermediate, and distal, each with a passage for a control wire, the control wire passage in the intermediate segment providing a larger lateral space than the passage in the distal segment provides for the control wire. In some embodiments, the surgical instrument includes a working channel also configured to aim in the aiming direction. In some embodiments, the system has at least one working channel that extends within an expandable sheath adjacent to the elongated tip control structure, thereby allowing the expandable sheath to expand. The elongated tip control structure may have at least one radiopaque portion configured for visibility under radiation outside the patient's body. The radiopaque portion may comprise one or more of a control wire and an enlarged mass at the end of the control wire formed from a high-density metallic material. The surgical instrument may include a laser configured to aim in the aiming direction. The elongated tip control structure may further include one or more radiopaque features associated with the elongated tip control structure, which are formed from a different material from the elongated tip control structure, so that the orientation of the elongated tip control structure can be indicated by visualization from radiation outside the patient's body.

[0012] The present technology has been briefly described above. The summary of the invention provides a simplified introduction to the selected concepts, which are further described throughout this application, including a detailed description of preferred embodiments. The summary of the invention is not intended to identify any important or essential features of the claimed subject matter, nor to limit the claims appended herein in any way. The features described above and those described below can be used in other combinations or individually, as well as in the combinations described, without departing from the scope of this application. A more complete understanding of these and other purposes, features, and advantages of the described technology can be achieved by considering the following text and accompanying exemplary drawings in addition to the exemplary embodiments, features, and characteristics described above.

[0013] A more specific description is provided below by referring to the specific embodiments shown in the accompanying illustrative drawings, in order to explain the described technology or to clarify the above and other features and advantages of the technology. These drawings depict selected forms of the described technology and should not be considered limiting its scope. The technology is described and explained in more specific and detail using these drawings. [Brief explanation of the drawing]

[0014] [Figure 1] A schematic diagram of a surgical system having external features, internal features, and support features shown in the perspective view is provided.

[0015] [Figure 2] The system according to claim 1 is shown, wherein the support features are arch-shaped.

[0016] [Figure 3] This shows a surgical device with detailed information on the working parts at the tip.

[0017] [Figure 4] The working parts of the surgical device are shown in assembly and exploded view diagrams.

[0018] [Figure 5] A diagram of an articulated tip section with a central shaft is shown.

[0019] [Figure 6A] Diagrams of the articulated tip from different perspectives are shown. [Figure 6B] Diagrams of the articulated tip from different perspectives are shown. [Figure 6C] Diagrams of the articulated tip from different perspectives are shown. [Figure 6D] Diagrams of the articulated tip from different perspectives are shown. [Figure 6E] Diagrams of the articulated tip from different perspectives are shown. [Figure 6F]Shows diagrams of the articulated tip from different viewpoints.

[0020] [Figure 7A] Shows another cross-sectional view of the articulated tip. [Figure 7B] Shows another cross-sectional view of the articulated tip. [Figure 7C] Shows another cross-sectional view of the articulated tip. [Figure 7D] Shows another cross-sectional view of the articulated tip. [Figure 7E] Shows another cross-sectional view of the articulated tip. [Figure 7F] Shows another cross-sectional view of the articulated tip. [Figure 7G] Shows another cross-sectional view of the articulated tip. [Figure 7H] Shows another cross-sectional view of the articulated tip. [Figure 7I] Shows another cross-sectional view of the articulated tip.

[0021] [Figure 8] Shows a perspective view of the articulated tip in a bent or arched configuration.

[0022] [Figure 9A] Shows a side cross-sectional view of the arched articulated tip of FIG. 8.

[0023] [Figure 9B] Shows a side view of the arched articulated tip of FIG. 8.

[0024] [Figure 9C] ]>Shows an end view of the arched articulated tip of FIG. 8.

[0025] [Figure 10A] Shows a side cross-sectional view of an arched or bent articulated tip with control wires.

[0026] [Figure 10B] Shows a side view of an arched or bent articulated tip with control wires.

[0027] [Figure 10C] A perspective view from slightly above and proximal to the arched or articulated tip equipped with a control wire is shown.

[0028] [Figure 11A] This demonstrates how the articulated tip helps guide surgical instruments along their path.

[0029] [Figure 11B] Figure 11A shows an end view of the same object (viewed looking back from the distal end).

[0030] [Figure 11C] This shows a perspective view from slightly distal to the upper part of the articulated tip in a relaxed, non-arched state.

[0031] [Figure 11D] A lateral view of the articulated tip in a relaxed, non-arched state is shown.

[0032] [Figure 12] Two perspective views of the working end of a surgical instrument are shown, with the lateral features shown in transparency to reveal the internal structure.

[0033] [Figure 13] The external material has been removed, but the internal structure remains in place. Side and perspective views of the articulated tip are shown.

[0034] [Figure 14A] A series of perspective views showing surgical instruments or tools passing through the apparatus are shown. [Figure 14B] A series of perspective views showing surgical instruments or tools passing through the apparatus are shown. [Figure 14C] A series of perspective views showing surgical instruments or tools passing through the apparatus are shown. [Figure 14D] A series of perspective views showing surgical instruments or tools passing through the apparatus are shown. [Figure 14E] A series of perspective views showing surgical instruments or tools passing through the apparatus are shown. [Figure 14F] A series of perspective views showing surgical instruments or tools passing through the apparatus are shown. [Figure 14G] A series of perspective views showing surgical instruments or tools passing through the apparatus are shown.

[0035] [Figure 14H] Similar to Figures 14E to 14G, this shows an end view (viewed from the distal end of the device) of a surgical instrument or surgical tool emerging from the device.

[0036] [Figure 15] This is a flowchart illustrating an exemplary method for introducing and aiming a camera, energy source, and surgical instruments.

[0037] [Figure 16] A schematic diagram of the surgical system is shown.

[0038] [Figure 17] A schematic diagram of a surgical system including an expandable internal channel is shown.

[0039] [Figure 18] A schematic diagram of the surgical system, including the ring, is shown.

[0040] [Figure 19] A schematic diagram of the surgical system, including the camera, is shown.

[0041] [Figure 20] A schematic diagram of a surgical system, including a camera positioned within a ring, is shown.

[0042] [Figure 21] A schematic diagram of a surgical system with a core and ribs is shown.

[0043] [Figure 22] A top view rendering of the surgical system is shown.

[0044] [Figure 23] A top view rendering of the surgical system is shown.

[0045] [Figure 24] This shows the expected surgical system.

[0046] [Figure 25] A top view rendering of a surgical system with an expandable internal channel is shown.

[0047] [Figure 26] A cutaway side view of the surgical system is shown.

[0048] [Figure 27] A cutaway side view of the surgical system is shown.

[0049] [Figure 28] This shows an exploded view of the actuator for a surgical system.

[0050] [Figure 29] This shows an internal view of the actuator for a surgical system.

[0051] The provided drawings are illustrative, and the technology is not limited to the exact arrangement shown. The described technology can be carried out in a variety of other ways, including those not shown in the drawings. The drawings and angles in this disclosure are not always to scale and are intended to depict typical embodiments of the disclosure in order to clearly illustrate the attributes of the technology, and should not be considered to limit the breadth, scope, or applicability of the described technology. Additional features and advantages of the described technology will be described and will become apparent from the following detailed descriptions of preferred embodiments. [Modes for carrying out the invention]

[0052] An endoscopic surgical system may have an endoscope comprising a hub, a shaft, and a working tip. The energy source can be either a fiber optic cable or a working channel, both extending through the shaft to the tip. The camera at the working tip may be surrounded by an elastic layer and supported by a support structure within the tip. This structure can aim the camera and energy towards the working zone. The structure can also facilitate the passage of surgical instruments through the working channel beyond the camera into the working zone while the elastic layer stretches. The structure may have a control unit to facilitate the aiming of the camera and beam. The structure may have a flexible frame and multiple attachments that interface with elongated structures such as cables, instruments, and channels. The attachments may have guide surfaces to facilitate the passage of instruments and protect the camera. The structure, elastic layer, and other aspects work together to facilitate the insertion of tine instruments and the micro-endoscopic sizing suitable for the most delicate surgeries.

[0053] Endoscopes are catheter-based devices that can be used to perform minimally invasive procedures (e.g., surgery). Endoscopes can be designed to allow medical professionals, such as physicians, to visualize and / or treat the internal tissues of a patient through a small incision in the skin. Endoscopes may include a light source and a camera. Fiberscopes (or fiber optic endoscopes) may include illumination fibers or light guides that direct light to illuminate the field of view. Endoscopes may include an imaging fiber bundle for transferring images of the illuminated area to the camera. In diagnostic arthroscopy, after the device is introduced into the patient's joint, the physician can illuminate that joint. The camera provides images of the joint, which are then viewed on a video monitor. By observing the joint in question through the device, the physician does not need to make a large incision. Sterile fluid can be used to dilate the joint, improving visibility of the joint area and facilitating the physician's work. These single-port diagnostic procedures have been performed in physicians' clinics and "walk-in" or outpatient surgical centers, for example, using 2.0 mm fiber optic arthroscopes or endoscopes.

[0054] The diagnosis and treatment of a patient often involve examination of internal organs and structures. In "open surgery," a large surgical cut or incision is made in the patient's skin and muscle. This allows the doctor to directly see and access the area being treated. However, large surgical wounds cause significant pain to the patient, often requiring the use of strong anesthetics and analgesics, such as narcotics, to maintain the patient's comfort during and after surgery, resulting in a considerable healing time and often restricting the patient's postoperative activity (especially if muscles have been cut to access the treatment area).

[0055] To avoid interfering with surrounding tissues, physicians use various imaging techniques to probe lumens, orifices, body openings, or other spaces. Such devices allow for remote observation of hard-to-reach spaces without large incisions and have been known by various names, including angioscopes, arthroscopes, borescopes, cystoscopes, endoscopes, and fiberscopes.

[0056] Arthroscopy is becoming increasingly common. Common arthroscopic procedures involve examining and treating damaged tissues within various body joints, such as removing or repairing torn portions of the meniscus cartilage, reconstructing ligaments and tendons, removing debris, and cutting or scraping away damaged articular cartilage. According to the American College of Sports Medicine and Orthopaedic Surgeons, millions of arthroscoes are performed worldwide each year. Other joints, including the shoulder, elbow, ankle, hip, and wrist, can also be observed and operated on through arthroscopy or endoscopy.

[0057] Endoscopy system In some embodiments, endoscopic systems are described. It should be understood hereby that whenever the term “endoscopy” (including variations of this basic term) is used herein, an endoscopic system is also explicitly assumed. Furthermore, while whenever “endoscopic system” (including variations of this basic term) is used herein, an endoscopic system comprising only a single endoscope, consisting of only a single endoscope, or essentially consisting of only a single endoscope is explicitly assumed, it should be understood that an endoscopic system is not necessarily limited to only a single endoscope.

[0058] In some embodiments, an endoscope system may include one or more working channels extending within the lumen of the sheath. For example, an endoscope system may include a working channel large enough to into which an instrument can be inserted. The working channel may be configured to allow an instrument inserted into the working channel to advance along the working channel and reach the distal end of the endoscope. In some embodiments, the working channel may have an opening at its distal end, thereby allowing the distal portion of the instrument to exit the distal end of the endoscope. The distal portion of the working channel may be expandable, and the portion overlapping the longitudinal direction of the outer sheath may also be deformable, thereby expanding the shape of the endoscope as an instrument in the working channel moves distally beyond an element in the lumen of the endoscope (e.g., an image sensor).

[0059] Endoscopic systems according to some embodiments may include additional working channels, such as a fluid flushing channel, a fluid suction channel, and one or more stylet working channels, to allow a second instrument to reach the distal end of the endoscope. The endoscopic system enables the visualization of tissue (e.g., via image sensors and illumination elements), tissue expansion (e.g., via the fluid flushing channel), and the performance of surgical procedures on tissue (e.g., via the working channels) using a single endoscope.

[0060] In some embodiments, the endoscopic system has an outer sheath comprising a lumen and an opening at the distal end of the sheath. The endoscopic system may include an image sensor (e.g., a camera) and an illumination element positioned within the lumen of the sheath. The illumination element may be configured to transmit light through the opening at the distal end of the sheath, illuminating the field of view. The image sensor can be adapted to detect light reflected from tissue illuminated by the illumination element, thereby allowing the user to visualize the tissue at the distal end of the endoscope. In some embodiments, the endoscopic system is a single-use endoscopic system used in surgical procedures.

[0061] In some embodiments, a laser supplies light to the illumination elements of the endoscope system. The laser can supply enough light to illuminate the field of view via a single light guide fiber. Therefore, in some embodiments, the use of a laser, and / or the use of a laser and a single light guide fiber, can reduce the diameter of the endoscope system, thus minimizing the invasiveness of the endoscope system.

[0062] Endoscopes may have a light source and a camera. Fiberscopes (or fiber optic endoscopes) may include both an illumination fiber or light guide for guiding light to illuminate the field of view and an imaging fiber bundle for transferring images of the illuminated area to the camera. In diagnostic arthroscopy, after the device is introduced into the patient's joint, the physician can illuminate that joint. The camera provides images of the joint, which are then viewed on a video monitor. By observing the joint in question through the device, the physician does not need to make a large incision. Sterile fluid can be used to dilate the joint, which improves the visibility of the joint area and makes the physician's work easier. These single-port diagnostic procedures can be performed in hospitals and "walk-in" or outpatient surgical centers using, for example, a 2.0 mm fiber optic arthroscope. These diagnostic procedures can be performed under local anesthesia to numb the area being examined, and the patient can remain awake throughout the procedure.

[0063] Endoscopes are used to actively treat or operate on a patient's joints. A physician can insert the endoscope into the joint. Additional perforations or incisions allow for cutting, scraping, joint particle removal, or tissue repair using other instruments during surgery. Alternatively, the endoscope may include working channels that allow surgical instruments (e.g., biopsy forceps and other instruments) to be inserted into and removed from the joint.

[0064] Surgical or therapeutic arthroscopy can have limitations. Surgical endoscopes with working channels of 3-4 mm in diameter may be more invasive and burdensome to the patient than smaller diagnostic endoscopes.

[0065] This disclosure describes a structure and method applicable to surgery in very confined spaces, using a simple, single-use device that allows for integrated packaging and sterilization. The micro-endoscope can be an articulated device having a bend at its distal tip. This can be achieved by forming a robust structural skeleton using metal, ceramic, plastic, carbon-based, or other materials. The degree of bend may be useful, for example, a 30-degree bend at the tip. The degree of bend can assist in the positioning and / or aiming of numerous surgical instruments, such as piezoelectric drills and treatment instruments. A laser fiber, used with the disclosed tip having a controlled bend, can deliver precise energy to site-specific anatomical structures. This may be useful, for example, in ENT procedures, urology (e.g., lithotripsy), and micro-spinal discectomy. The endoscope described in this disclosure can be used in many applications, including arthroscopic joint examinations and surgeries of the hand, shoulder, and knee, as well as surgeries of the bile ducts (related to the liver), airways, ear, nose, throat, lungs, and blood vessels. In fact, the described device is useful for general surgical use.

[0066] Various exemplary embodiments of the described technology are shown in the drawings and described below, provided to enable the manufacture and use of various embodiments and examples of the technology. Descriptions of specific materials, techniques, and applications are provided as examples. No limitation to the scope of the technology or the claims should be attributed to the following drawings, examples, or descriptions.

[0067] Figure 1 shows a surgical system 110, which may include an external feature 112, an internal feature 116, and an intervening support feature 120. The external feature 112 may be the exterior of an elongated surgical instrument and may be configured to be inserted into a biological passage such as a blood vessel. The internal feature may be a surgical instrument, a passage for one or more surgical instruments, a plurality of such passages, a control device such as a guidewire or control wire, or two or more of these features or instruments. The support feature 120 may comprise an articulated tip such as a support structure, a directional or guiding structure, or an endoskeleton. The surgical system 110 may have multiple parts that work together to perform complex surgery in a microspace within a living body such as the human body. The surgical system 110 may comprise a microendoscopy. An example of the support feature 120 is shown as an articulated tip 124. The articulated tip 124 may have a trunk 122 on which a distal rib 126, a central rib 127, and a proximal rib 128 are supported. In some embodiments, the proximal end 134 can be brought closer to a physician or nurse so that surgical instruments, cameras, fiber optic lights, and other instruments can protrude from the distal end 132 to perform complex surgeries, and the distal end 132 can be brought closer to the working end of the surgical system 110.

[0068] This application incorporates, by reference, for all purposes all that it contains, U.S. Patent No. 9,913,570, entitled “Endoscope with Variable Morphology Tip” (see Annex A). The methods and structures described herein can be used in connection with the disclosures provided herein. For example, this patent provides disclosures relating to variable morphology channels and elastic materials. The variable morphology channels and expandable tips described herein can be advantageously incorporated into the endoskeleton structures (referred to as articulated tips) described herein. For example, by providing rigid internal supports, side grooves, etc., the variable morphology channels can freely pass through the articulated tip and expand outward as needed (limited to some extent by the elasticity of these passages and / or an outer sleeve such as the elastomer sleeve 1254 described elsewhere herein), allowing instruments or other surgical materials to pass through the channels.

[0069] Figure 2 shows a surgical system 210 having an external feature 212, an internal feature 216, and a support feature 220. In this figure, the support feature 220 is in a bent configuration, which facilitates direction, movement, observation or exploration, illumination, etc. One embodiment of the support feature 220 is shown below in three dimensions. This figure shows that the base 222 of the articulated tip 224 is in a bent configuration such that the distal rib 226 approaches the central rib 227 slightly, and the proximal rib 228 also approaches the central rib 227 slightly. Therefore, in this figure, the proximal end 234 is inclined downward, and the distal end 232 is also inclined downward. Both the articulated tip 124 in Figure 1 and the articulated tip 224 in Figure 2 show internal passages extending through ribs 126, 127, 128, 226, 227, and 228. These internal passages can provide space for various surgical instruments to pass through, and their shape and relative arrangement can provide more convenient passages and access for multiple surgical instruments.

[0070] In some embodiments, the endoscopic system includes a piezoelectric element connected to the working tip. The piezoelectric element drives the working tip, allowing it to puncture patient tissue such as bone. Therefore, in some embodiments, the endoscopic system may be useful for performing microfracture surgery using a single endoscope and a single incision.

[0071] In some embodiments, the endoscopic system includes a hook-shaped blade that can be deployed from a working channel. Once deployed, the hook-shaped blade can cut through connective tissue. In some embodiments, the shaft of the endoscopic system can function as a tissue expander when slid along the median nerve, after which the hook-shaped blade can be deployed to cut through the carpal ligament. Thus, in some embodiments, the endoscopic system may be useful for carpal tunnel surgery utilizing only a single endoscopic system and a single incision.

[0072] In some embodiments, a stylet can be used to perform arthroscopic procedures. Certain joints, such as the hip or the back of the knee, may be difficult to visualize with conventional endoscopic systems. The operator can change the stiffness of the shaft of the endoscopic system by replacing the curved stylet within the shaft. The stylet may be configured to advance through the working channel of the endoscopic system described herein. Thus, in some embodiments, the operator can adjust the position of the tip using one or more stylets. In this way, the field of view for illumination and / or imaging can be modified by the use of stylets. Thus, in some embodiments, one or more stylets can facilitate visualization of hard-to-reach locations.

[0073] This application incorporates, for all purposes, by reference the entirety of U.S. Patent No. 10,687,698, entitled “Direct Intraluminal-and / or Intravascular-Illumination System and Method of Use thereof” (see Appendix B). Methods and structures described herein can be used in connection with the disclosures provided herein. For example, this disclosure provides details relating to the use of an expandable cuff at or near the tip of a surgical instrument. Such a method may help, for example, isolate a working area from an access route, prevent fluid loss, and reduce the risk of infection. The cuff (and other instruments disclosed herein) can be expanded, steered, positioned, or manipulated using a tension wire, a piezoelectric device, etc. These movements may occur through or in the presence of an articulated tip having the structures or characteristics described in Figures 1 to 14. For example, the cuff described herein can be advantageously incorporated into an endoskeleton structure (referred to as an articulated tip) described herein. For example, by providing rigid internal supports, side grooves, etc., the cuff may freely pass through the articulated tip, expand outward as needed to form a seal, or press against the sides of the internal volume.

[0074] Figure 3 shows a surgical device 340. Such a device may, for example, include an endoscope for providing surgical access. In some embodiments, the device may be a micro-endoscopy. One end may have connectors such as a camera connector 348 and an optical fiber connector 342. These can be connected to a main cable section. 346 then proceeds toward a handle 344, a hub 345, and a shaft 347, which may terminate at a working section 350. The hub 345 may provide additional access ports as shown (these may, in some embodiments, lead to an expandable dedicated internal channel or tube). The device 340 may have an elastomer sleeve 354 at the end of the shaft 347. This elastomer sleeve 354 may form a surrounding cover over the working end 352.

[0075] Characteristics of Endoscopes The surgical device 340 may be an endoscope. The surgical device 340 may have, for example, an extendable tip (e.g., in the working part 350), a shaft (e.g., shaft 347), a connecting hub (e.g., hub 345), a connector assembly, and connectors such as a USB connector (or other power, fluid, control, data, and / or optical connectors). The endoscope may have an overall working length (total length of the shaft and distal tip) of 5 cm to 200 cm, preferably 10 cm to 100 cm, most preferably 12 cm to 60 cm. The working length may be long enough to position the tip of the endoscope 1 inside the patient's body so that relevant anatomical structures can be viewed, while keeping the connecting hub outside the patient's body.

[0076] The shaft may extend from the distal tip to the connecting hub. The shaft can transmit torque (rotation) applied around the longitudinal axis of shaft 3. Torque applied to the proximal end of the shaft is transmitted along the length of the shaft to the distal tip. In some endoscopes, shaft 3 is flexible and can be bent around its transverse axis with a relatively small bending radius. This allows the endoscope to be manipulated around anatomical structures during medical procedures. However, in other applications, part or all of the shaft is rigid or semi-rigid.

[0077] The shaft can be made from any biocompatible material with appropriate strength properties (e.g., flexibility and strength in extension and compression, as well as providing appropriate torque transmission from the proximal end to the distal end). Materials that can be used to make the shaft include biocompatible polyamides, polyesters, polyetheretherketones, polyetherurethanes, polyimides, polytetrafluoroethylenes, and polyurethane epoxys. Reinforcing materials can be incorporated into the shaft to provide additional strength or stiffness. Such reinforcing materials include copper alloys, nickel alloys (e.g., Nitinol), stainless steels, and high modulus plastics such as polyimides.

[0078] The connecting hub may include one or more connectors for tools, cleaning fluids, and stylets, as well as optional electronic equipment. The connecting hub may have a size and shape that accommodates these components. The electronic equipment within the connecting hub may include a PCA with circuitry for controlling the endoscope (described later) and a camera signal transmission system. Alternatively, the PCA may function as an interconnection to an external control circuit located outside the endoscope. If electronic equipment within the hub is not particularly required, the hub can be made very small and may function as a connection junction between other tubes, wires, and optical fibers.

[0079] The hub can be made from biocompatible plastics such as polycarbonate, acrylic, acrylonitrile butadiene styrene (ABS), cast epoxy, and thermosetting plastics. Metal housings formed from multiple grades of stainless steel or other biocompatible materials such as titanium are also possible.

[0080] The coupling hub has a distal portion and a proximal portion and may include one or more ports or connectors and strain relief features. These connectors may include seals to provide a fluid-tight seal between the coupling hub and the connector (e.g., a Luer Lock® locking component).

[0081] The connectors can be securely attached to the connecting hub, allowing the physician to introduce instruments and fluids from the hub for use at the distal tip of the endoscope. This can be achieved by bonding, heat welding, potting with thermosetting plastic or epoxy, RF welding, screw fastening with screw connections, solvent bonding, ultrasonic welding, or a combination of these processes. Any or all of the connectors can be attached to the flexible tube that enters the hub.

[0082] The lavage channel connector allows fluid to be introduced from the hub and to move through the lavage lumen. A stylet channel connector may allow a stylet (not shown) to be inserted from the hub and guided into the stylet channel. The stylet may be intended to influence the shape of the flexible shaft of the endoscope. For example, a malleable and elastic wire made of a material such as 300 series stainless steel can be bent to a desired curvature or angle and inserted through the stylet channel to conform the flexible endoscope to such curvature or angle. The working channel connector 10 allows an instrument to pass from the hub through the working channel into the shaft and reach the working channel portion in the distal tip.

[0083] More than two working channels may be included. If multiple working channels are used, they may be the same size or different sizes. Some or all of the working channels may have variable morphological features. For example, a 5mm endoscope may have two 1.2mm working channels, both of which may have variable morphological features. A variable morphological distal tip may allow the physician to insert the endoscope through a minimal incision or puncture size (e.g., a 12-gauge needle) while in a thin configuration. The tip section expands as the endoscope enters the treatment area. An expanded morphological configuration (see, for example, Figure 14h in Figure 14) can be achieved, for example, by passing an instrument with a maximum diameter of 1.0mm through the working channel tip 23 and / or by passing a lavage fluid (0.9% saline in sterile water) through the lavage channel 24 at a speed sufficient to expand the lavage channel 24 at the distal tip 2.

[0084] Three connectors can be used for each of the lavage lumen, stylet, and working channel. Depending on the characteristics of the lavage lumen, stylet, and working channel of a particular endoscope, one connector may be used, or any number of connectors may be used. For example, an endoscope with two working channels, a stylet, and a lavage lumen may have four separate connectors.

[0085] Electrical cables and USB connectors can provide interfaces between circuits within the linking hub and external devices. They may include conductors for supplying power to light sources within the linking hub and have contacts for transmitting signals output from a camera to a connector (such as a USB connector). Multiple cables can be used, for example, a first cable for conducting power to light-emitting diode (LED) light sources within the linking hub (which can transmit light along an optical fiber path), and a separate second cable for transmitting signals received from a camera.

[0086] The connector (e.g., a USB connector) can be connected to an external control / display device or an electronic interface box, which can convert the signals into signals usable by the external control or display device. The connector (e.g., a USB connector) may also supply power to the electronic endoscope. Other wired connections (e.g., HDMI®) and wireless connections (e.g., Bluetooth, WiFi) can be used as alternatives to, or in addition to, the USB connector.

[0087] The connecting hub may be subjected to various forces during use, including bending forces. Strain relief features can protect the hub and its components from these forces. Such features may include relatively rigid injection-molded thermoplastics (e.g., acrylonitrile butadiene styrene (ABS)) or more flexible materials such as the previously specified TPE. When using TPE, it is preferable that the TPE has a higher hardness value than the components of the expandable tip.

[0088] Figure 4 shows additional diagrams of the working portion 450 of a surgical device, such as the surgical device 340 shown in Figure 3. Figure 4 includes an exploded view of the elastomer sleeve 454 separated for illustrative purposes to reveal the internal structure. For example, an articulated tip 424 having a core 422 is shown to generally house and surround an optical fiber light 466 and a camera 462, with supporting features such as cables running back from the working portion and terminating at the camera 462 and optical fiber light 466. The shoe 464 can be positioned so that the optical fiber light 466 passes through an internal passage of the shoe 464, and can also be mounted on the lateral surface of the camera 462.

[0089] The working portion 450 (defined, for example, by an elastomer sleeve 454) may have a length in the range of, for example, 3 mm to 50 mm, preferably 7 mm to 15 mm, and most preferably 8 mm to 10 mm. The working portion is expandable and expandable. In the thin state, the cross-sectional area of ​​the working portion is reduced, and the outer diameter is in the range of about 1.5 mm to 20 mm, preferably about 1.5 mm to 5 mm, and most preferably about 1.5 mm to 2.0 mm. In the expanded or extended state, the cross-sectional area of ​​the working portion is increased to accommodate one or more instruments passing through one or more channels. For example, the expanded state may accommodate instruments having a circular cross-sectional shape with a diameter in the range of 1.8 mm to 20 mm, preferably 2 mm to 5 mm, and most preferably 1 mm to 2 mm. The change in shape allows the instrument to pass through the camera 22 and eventually exit the distal tip of the endoscope. This expansion is not hindered by the presence of the articulated tip 424 because, despite having a substantially rigid structure, the articulated tip 424 has a lateral opening that allows for lateral expansion of the elastomer sleeve.

[0090] The tip may contain one or more illumination fibers, such as flexible optical fiber light guides. These fibers can carry light from a light source in the connecting hub to the distal tip of the endoscope, illuminating the field of view. The illumination fibers can be made of glass, PMMA, or other light-transmitting materials. Combinations of fibers of different sizes can be used only if they fit within the cross-sectional area of ​​the distal tip in a thin configuration and provide sufficient illumination intensity.

[0091] The camera 462 and illumination fiber (e.g., optical fiber light 466) can be positioned so that the area to be imaged or manipulated is adequately illuminated. In the illustrated configuration, the camera 462 may be located approximately in the center of the distal tip. The working channel, secondary channel (e.g., lavage lumen), and any illumination features can be distributed at angles around the circumference, as further shown in Figure 12.

[0092] The outer cover (e.g., elastomer sleeve 454) and any channels (working and secondary) can be made of a sterilizable polymer material. Within at least the expandable tip portion, these structures are configured to be shape-shifting or expandable. Each of these structures may be made of the same material or different materials. For example, each could be made of a biocompatible elastomer tube (e.g., latex rubber, silicone rubber, or various USP Class 6 compliant TPEs). Exemplary TPEs are mentioned above.

[0093] Figure 5 shows a diagram of an articulated tip 524 having a core 522. The core 522 may have a distal thin-walled portion 572 and a proximal thin-walled portion 574. These thin-walled portions may be interposed between the distal rib 526, the central rib 527, and the proximal rib 528, which are attached to the core 522 by support sections such as the proximal rib support 576 and the central rib support 577. This figure shows how these rib supports and ribs may have smooth or other contoured shapes, edges, and forms that can assist, for example, in surgical procedures, in passing surgical instruments through the surgical system 110, particularly from the articulated tip 524. Figure 5 also shows a control structure 578 that can interact with a control device, such as a control wire.

[0094] Figures 6A to 6F show multiple views of the articulated tip, which is consistent with the articulated tip 524 in Figure 5. Figure 6a shows a side view with the main trunk 622 facing the bottom and the distal rib 626, central rib 627, and proximal rib 628 facing the top. The proximal rib support 676 and central rib support 677 are shown. Figure 6b shows a top view looking down on the main trunk 622, showing the distal thin-walled portion 672 and proximal thin-walled portion 674. These thin-walled portions are also shown in 6c, which shows a side view. The guide angle 680 is indicated by a. This guide angle 680 may also have contours such as the taper 682 shown in 6f. Figure 6e shows an end view of the articulated tip from the proximal side. Figure 6d shows an end view of the articulated tip looking back from the distal side towards the working end in the proximal direction. In this figure, the front edge 686, which is the front of the rib support 677, can be seen. Figures 6e and 6d include target marks to indicate where control wires can be placed within the illustrated structure, but the targets do not represent the structure itself.

[0095] The diagram in Figure 6 is useful for illustrating some relative dimensions of a useful bending structure. The articulated tip has a substantially cylindrical outer shape, with an outer diameter of 1.6 mm and a length of 7.9 mm. In such embodiments, in a relaxed (unbent) configuration, the distance between the ribs of the articulated structure is 0.8 mm, and the length of each thin-walled base portion can be 2.7 mm (while the central base portion between these two is shorter, for example, 0.9 mm in length). The length of the thin-walled portions and the distance between the ribs can be useful in determining how much the articulated tip bends, so the dimensions described herein generally correspond to a configuration that bends by 30 degrees. Similarly, other structures (e.g., the rib portions that form the guide angle 680 in Figure 6) can provide constraints on the bending potential of the articulated tip, similar to the structural constraints provided, for example, by the vertebral ridges in the animal kingdom. The guide angle 680 may be the same as the expected overall bending angle of the articulated tip 124. Therefore, the guide angle 680 indicated as "a" in Figure 6 can be 30 degrees if the structure has the dimensions (or proportional dimensions) described herein. In this embodiment (for example, matching the dimensions shown in Figure 6), the total width of the distal rib 626 can be 1.41 mm (which may correspond to the width seen in 6b and 6f), which can be wider than the substantially tubular structure of the rest of the articulated tip (see the outer diameter of 1.6 mm, which corresponds to the height in side views 6c and 6a).

[0096] Figures 7A to 7I show cross-sectional views of the articulated tip 724. Figure 7I corresponds to Figure 6E in Figure 6, and Figure 7H corresponds to Figure 6D in Figure 6. Figure 7A is a cross-section taken along the central longitudinal axis of the articulated tip 124 in Figure 1. As shown by the vertical lines, Figure 7B is a cross-section taken toward the distal end (left side of this figure), Figure 7C is a cross-section taken slightly proximal, Figure 7D is a cross-section taken even more proximal (through the central rib), Figure 7E is a cross-section taken through the central rib support 777, Figure 7F is a cross-section taken further toward the proximal end, and Figure 7G is a cross-section taken even closer to the proximal end (through the distal rib support 776). Therefore, Figures 7B and 7C show cross-sections through the distal rib 726, Figures 7D and 7E provide cross-sectional views of the central rib 727, and Figures 7F and 7G provide cross-sectional views of the proximal rib 728. These cross-sectional views show different internal morphologies along the length of the articulated tip. Figures 7C, 7D, and 7F show cross-sectional views of the distal thin-walled portion 772 and the proximal thin-walled portion 774 of the base 722 at the top. Figure 7C shows a proximal-facing marginal contour 782, which can help guide or redirect surgical instruments as they pass through the articulated tip 724.

[0097] Figures 7A to 7I are also useful for providing exemplary dimensions. One dimension that may be important is the diameter of the small cylindrical passage in Figure 7B (extending inward from the frustoconical wire seat 792) and Figure 7F (thin tube 790), as this diameter allows for the passage of the control wire having the enlarged tip 1011 (detailed in relation to Figure 10). In some embodiments, the inner diameters of both of these can be 0.08 mm, and the length of the portion of the proximal rib 728 containing this thin tube 790 can be 0.5 mm. In contrast, the larger inner diameter of Figures 7D and 7E (passage 794) can be 0.51 mm, and the inner diameter of the passage shown in Figure 7G can be 0.35 mm, with a length of 1.25 mm. The total length of the articulated tip can be 7.9 mm, the length of the central rib 727 can be 2.8 mm, and the distance between the ribs can be 0.8 mm. The vertical width of the thin-walled core sections 772 and 774 can be 0.2 mm.

[0098] Figure 8 shows an articulated tip 824 in a flexed configuration. The articulated tip 824 has a main section 822, a distal thin-walled section 872, and a proximal thin-walled section 874. It also has a distal rib 826, a central rib 827, and a proximal rib 828.

[0099] Figure 9A shows a side section of the bent or arched articulated tip of Figure 8. Figure 9B shows a side view, and Figure 9C shows an end view. Figure 9A shows a section taken along the line B-B shown in Figure 9C. Figure 9B shows a side view, where the overall bend 997 is indicated by x and the two partial angles 996 are indicated by y, respectively. The distal thin-walled portion 972 and the proximal thin-walled portion 974 are both bendable due to their thin, flat geometric shapes. This results in partial angles 996 (distal and proximal), which can then establish the overall tip bend angle 997.

[0100] Figure 10A shows a side section of the arched or articulated tip 1024 with a control wire. Figure 10B shows a side section of the arched or articulated tip 1024 with a control wire. Figure 10C shows a perspective view of the arched or articulated tip 1024 with a control wire, from above and slightly proximal. Figure 10A provides a section similar to that of Figure 9A. Figure 10B provides a side view similar to that of Figure 9B. Figure 10C provides a perspective view similar to that of Figure 8. In Figures 10A to 10C, the overall bending angle is shown as 35 degrees, with two partial angles each showing a bend of 17.5 degrees. The tension wire 1013 can pass through the ribs of the device and has an enlarged distal tip 1011. In some embodiments, a bend such as the 35-degree bend shown in this figure can be produced by the user pulling the tension wire 1013 at the proximal end.

[0101] In addition to the disclosed tension wire 1013, other means can be provided and / or used to control, aim, steer, or otherwise maneuver the endoscope. For example, piezoelectric elements can be used and incorporated into the articulated tip.

[0102] This application incorporates, for all purposes, by reference the entirety of U.S. Patent Publication No. 2020 / 0155190, entitled “Endoscopic System and Method of Use thereof” (see Appendix C). The methods and structures described herein can be used in connection with the disclosures provided herein. For example, the disclosure provides details relating to the use of piezoelectric elements, which may be useful for steering, guiding, aiming, or otherwise maneuvering the tip of an instrument or access or other related structure at or near a surgical site. Instruments disclosed herein (e.g., stylets, hook blades, etc.) can be started, steered, positioned, or manipulated using tension wires, piezoelectric devices, etc. These movements may occur through or in the presence of articulated tips having the structures or characteristics described in Figures 1 to 14. For example, instruments such as piezoelectric elements, stylets, or hook blades can pass through variable morphological channels and expandable tips (referred to as articulated tips) incorporated into the endoskeleton structures described herein. For example, by providing rigid internal supports, side grooves, etc., piezoelectric elements, stylets, or hook-shaped blades can freely pass through the articulated tip and shift or extend outward as needed when these instruments are positioned for surgery (though this is constrained to some extent by the elasticity of the surrounding structure, such as an expandable working channel and / or sleeve (e.g., elastomer sleeve 1254 as otherwise described herein)).

[0103] Figure 11A shows how the articulated tip guides a surgical instrument along its path. Figure 11B shows an end view of the same object as in Figure 11A (viewed looking back from the distal end). Figure 11C shows a perspective view of the articulated tip in a relaxed, non-arched state, from slightly distal to the top. Figure 11D shows a side view of the articulated tip in a relaxed, non-arched state. Together, Figures 11A and 11B show how the articulated tip 1124 assists in guiding a surgical instrument along its path 1113. For example, a guide angle 1180, which may be 30 degrees as shown in this example, can be formed by the contoured guide surface 1121. As a surgical instrument enters the articulated tip 1124 from an entry point 1115 (visible in the end view of Figure 11B, viewed distally from a proximal viewpoint), similar lateral groove passages, opposite to those shown in 1123, may help guide the surgical instrument through an elongated path within the articulated tip 1124. The lateral passages may comprise a series of aligned grooves located between sections of the trunk and associated rib projections, similar to the articulated features of mammalian endoskeletons. Surgical instruments passing through this series of aligned grooves may also be within a larger tubular structure enclosing the entire articulated tip 1124, and the instruments may also pass through and / or be guided by, for example, an internal tube or channel (see, for example, the working channel and secondary channel described in relation to Figure 12 below). A series of secondary groove channels, including the lateral groove passage 1123, may guide a second surgical instrument (e.g., a channel for irrigation fluid, another instrument). In some examples, surgical instruments may exit the surgical apparatus at an instrument exit angle 1119, such as the 3.25-degree angle shown here. This angle can be measured from the central axis. Surgical instruments may have different lateral morphologies, and may have an anterior portion that is more rigid and / or wider than the posterior portion.

[0104] Figure 12 shows a diagram of the working end 1252 of a surgical instrument. This working end can correspond, for example, to the structure shown in Figure 4 and may include a working portion 450. The elastomer sleeve 1254 can be provided to surround other structures at the working end 1252. These structures may include, for example, a working channel 1233, shown here in an unexpanded state, which, when compressed, forms an arc-shaped cross section toward the right side inside the working end 1252. Similarly, a smaller secondary channel 1237 is shown pressed against the left side, optionally. The elastomer material of the sleeve 1254 is expandable to accommodate the passage of instruments, materials, fluids, etc., through one or both of the working channel 1233 and the secondary channel 1237. The optical fiber tip 1266 can also be seen adjacent to the camera 1262. The articulated tip can also be seen partially hidden by the elastomer sleeve 1254 in both perspective views.

[0105] Figure 13 shows the articulated tip 1324 with the elastomer sleeve material removed. In this figure, it can be seen that the optical fiber cable 1345 extends toward the optical fiber tip 1366, which is fixed or positioned within the shoe 1364. Similarly, the camera harness 1343 can be seen passing along the various ribs of the articulated tip 1324 (through gutter channels such as the gutter passage 1123 in Figure 11) and connecting to the camera 1362 at the distal end of the device. Both the optical fiber cable 1345 and the camera harness 1343 pass alongside the proximal rib 1328 and the central rib 1327. However, both the optical fiber cable 1345 and the camera harness 1343 pass inside the distal rib 1326, which is large enough to accommodate the passage of both. In some embodiments, the distal rib can be configured to physically house or serve as the shoe portion 1364, and can also accommodate and / or house the camera 1362. As can be seen from Figures 11 and 13, surgical instruments can pass along one side of the ribs 1328 and 1327, while the fiber optic cable 1345 and camera harness 1343 pass along the other side of the same rib. At the distal tip, the fiber optic cable 1345 within the camera harness 1343 can pass through the distal rib 1326, guided by a contoured guide surface 1121 not visible in Figure 13, while the surgical instruments pass along the side. If a channel (e.g., see secondary channel 1237 in Figure 12) passes along the side of the same rib as the camera harness 1343 and / or fiber optic cable 1345, this channel may, advantageously, be smaller or have a different shape than another channel (e.g., working channel 1233 in Figure 12) that does not need to share space.

[0106] The camera harness 1343 can be called a camera cable. It may extend from camera a to the connecting hub. The camera cable can be a simple signal conductor (e.g., 24AWG gauge copper wire with a diameter of approximately 0.52 mm) or a ribbon cable with multiple insulated conductors. Exemplary conductor compositions include copper, copper alloys, MP35N, DFT, platinum, platinum / iridium, tungsten, gold, and stainless steel. The conductors can be bare, tin-plated, silver-plated, or gold-plated. A variety of insulating materials can be used, including fluorinated ethylene propylene (FEP), perfluoroalkoxy (PFA), and polytetrafluoroethylene (PTFE). For example, a ribbon cable may consist of four conductors: (1) ground, (2) serial data line, (3) serial clock line, and (4) power line (e.g., using a 41AWG silver-plated copper conductor).

[0107] Figures 14A–14G show a series of perspective views of a surgical instrument or surgical tool as it passes through the device. Figure 14A shows the initial stage where the camera 1462 is visible at the distal end of the device. In Figure 14B, the surgical instrument 1453 can be seen entering the elastomer sleeve section from the right-hand (presumably more rigid) shaft. For illustrative purposes, in Figures 14D, 14C, and 14D, the sleeve or elastomer tip has been removed. Figure 14B shows the optical fiber tip 1466 appearing to protrude next to the camera 1462. In Figure 14C, the surgical instrument 1453 continues to pass through the support ribs of the articulated tip within the device. In Figure 14D, the surgical instrument 1453 begins to contact the contoured guide surface of the articulated tip within the device (see, for example, the surface labeled 1121 in Figure 11). This allows the instrument to be guided beyond the assembled tip head (e.g., the camera and fiber optic tip within the shoe). In Figure 14E, the surgical instrument 1453 can be seen bulging from the distal tip, while the elastomer sleeve 1454 is shown bulging laterally in response to the passage of the surgical instrument 1453. In Figure 14F, the surgical instrument 1453 protrudes further, and in Figure 14G, the surgical instrument 1453 continues to extend beyond the distal tip. Many surgical instruments have a rigid or less flexible portion at the distal tip and a more flexible portion located proximal. Therefore, at the time and position shown in Figure 14G, the surgical instrument 1453 can extend its articulated tip so that the instrument can be guided to rotate laterally when the user engages or tightens a control wire at the proximal end of the surgical instrument. Similarly, when the instrument is in the extended position shown in Figures 14F and 14G, it can be seen by camera 1462, making it useful and functional for many surgical procedures that use both the instrument and the camera.

[0108] Figure 14H, like Figures 14E to 14G, shows an end view (viewed from the distal end of the device) of a surgical instrument or surgical tool emerging from the device. In Figure 14H, the surgical instrument 1453 is located on the right side and is expanding, filling the working channel 1433, while the camera tip 1462 is also seen pointing outward from the articulated tip 1424. The shoe 1464 surrounds and houses the optical fiber tip 1466, and the working channel 1437 can be seen on the left side of the figure, but it is not currently expanded.

[0109] Figure 15 is a flowchart illustrating an exemplary method for introducing and aiming a camera, energy source, and surgical instrument. Step 1510 provides an elongated shaft configured to extend to the surgical site. Step 1520 positions the camera, energy source, and articulated support structure at the surgical end of the elongated shaft. Step 1530 provides an elastic sleeve in a substantially cylindrical space around the rigid support structure. Step 1540 passes an elongated surgical instrument having a rigid anterior portion through the elongated shaft such that the anterior portion passes through the elastic sleeve and adjacent to the articulated support structure, thereby displacing the anterior portion laterally so that the anterior portion stretches the elastic sleeve, bypasses the camera and energy source, and extends into the field of view of the camera and energy source.

[0110] In addition to, or as an alternative or clarification thereof, the method may further include providing an elongated control device that physically interfaces with an articulated support structure to change the aiming direction of the camera and energy source. The control device may be a tension wire configured to sit at the distal end of the articulated support structure, pass there longitudinally, and extend through an elongated shaft away from the surgical site, and the method may include changing the aiming direction by pulling the tension wire. The method may also include providing a laser as an energy source, using the laser to supply energy to the tissue at the surgical site, transmitting optical information from the camera posteriorly through the elongated shaft, and simultaneously controlling the aiming direction of the camera and laser from the proximal end of the shaft. The articulated support structure may comprise a core and three rib sections, configured such that the distal rib section supports and protects the camera, the more proximal ribs provide rigidity to the surgical end of the elongated shaft, and the ribs together provide a pathway for any elongated surgical instrument within an elastic sleeve. A continuous working channel may extend through an elongated shaft and through an elastic sleeve in an articulated support structure. Passing an elongated surgical instrument through an elongated shaft may involve passing the instrument through a continuous working channel.

[0111] Figure 16 shows a surgical system 1600. The surgical system 1600 may be similar to or identical to the surgical systems 110 or 210 described above. The surgical system may include an external feature 1610, a wire 1620, and a wire connection feature 1630. The external feature 1610 may be the exterior of an elongated surgical instrument and may be configured to be inserted into a biological passage such as a blood vessel. In some embodiments, the external feature 1610 may be an elastomer sleeve as described herein. In some embodiments, the external feature may include a distal end 1612 and a proximal end 1614. In some embodiments, the distal end 1612 is expandable in response to the passage of an instrument or other object through the external feature 1610. In some embodiments, only a portion of the distal end 1612 is wearable. The proximal end 1614 may be more rigid than the distal end 1612, such that the proximal end 1614 does not expand, or expands not to the same extent as the distal end 1612.

[0112] The wire 1620 is located within the external feature 1610. In some embodiments, the wire 1620 is a tension wire, a guide wire, or a control wire. The wire 1620 is connected to the wire-connected member 1630. In some embodiments, the wire 1620 is connected to the wire-connected member 1630 at a first lateral 1632 of the wire-connected member 1630. In some embodiments, the wire 1620 is connected to the wire-connected member 1630 such that the distal end 1612 of the external feature 1610 bends when the wire 1620 is pulled.

[0113] As can be seen in Figure 17, in some embodiments the surgical system 1600 may include an expandable internal channel 1640. The expandable internal channel 1640 may be similar to or identical to the variable-form working channel described herein. The expandable internal channel 1640 is located within the external feature 1610 and is configured to expand in response to the passage of an instrument. In some embodiments, the expandable internal channel 1640 is located adjacent to the wire connection member 1630. In some embodiments, the external feature 1610 is configured to expand in response to the expansion of the expandable internal channel 1640.

[0114] Figure 18 shows another embodiment of the surgical system 1600. As seen in Figure 18, the wire connector 1630 is a ring 1650. In some embodiments, the ring 1650 is rigid. In some embodiments, the wire 1620 is connected to the first half 1654 of the ring 1650. In some embodiments, the first half 1654 of the ring 1650 is rigid. In some embodiments, the first half 1654 of the ring 1650 is more rigid than the second half 1656 of the ring 1650. In some embodiments, the second half 1656 of the ring 1650 may be flexible. In some embodiments, the wire connector 1630 is a half-ring.

[0115] In some embodiments, as shown in Figure 19, the wire connector 1630 is a camera 1660 similar to or identical to the camera described herein. The wire 1620 may be attached to the first side 1662 of the camera. In this configuration, pulling the wire 1620 changes the orientation of the camera 1660, thereby changing the field of view of the camera 1660. In some embodiments, the external feature 1610 is configured to bend when the camera 1660 changes orientation.

[0116] Figure 20 shows a surgical system 1600. As seen in Figure 20, the wire connecting member 1630 is a ring 1650 or a half-ring. The wire 1610 is connected to the ring 1650 on the first half 1654 of the ring 1650. The system further includes a camera 1660. The camera 1660 is positioned within the ring 1650. In some embodiments, the camera 1660 is mounted on the ring 1650 such that the field of view of the camera 1660 changes when the wire 1610 is pulled.

[0117] The system 1600 further includes an expandable internal channel 1640. The expandable internal channel 1640 is located within an external feature 1610 adjacent to the ring 1650 or camera 1660. In some embodiments, the expandable internal channel 1640 is configured to expand in response to the passage of a tool. In some embodiments, a second half 1656 of the ring 1650 is configured to expand or deform in response to the expansion of the expandable internal channel 1650 as the expandable internal channel 1650 expands.

[0118] Figure 21 shows a diagram of the wire 1620 connected to the ring 1650. As can be seen in Figure 21, the wire 1610 may include a base 1670. The base 1670 may be similar to or identical to the bases described herein. In some embodiments, the base 1670 may be attached to the external feature 1610. In some embodiments, the base 1670 is connected to the wire 1620. The base 1670 is configured to support the external feature 1610 when the external feature 1610 is bent by the wire 1620 pulling the ring 1630. In some embodiments, the base 1670 beneficially allows the external feature 1610 to bend without bending.

[0119] In some embodiments, the core 1670 may include at least one rib 1680. The rib 1680 may be similar to or identical to any of the ribs described herein. In some embodiments, at least one rib 1680 is configured to provide additional support to the core 1670. In some embodiments, at least one rib 1680 is configured to prevent the core 1670 from bending excessively.

[0120] Figure 22 shows a top perspective view of a surgical system 1600 similar to or identical to the surgical system 1600 shown in Figure 20. As can be seen in Figure 22, the surgical system includes an external feature 1610, a wire 1620, a wire connector 1630, an expandable internal channel 1640, a camera 1660, and a light source 1690.

[0121] The external feature 1610 can be the exterior of an elongated surgical instrument and may be configured to be insertable into a biological passage such as a blood vessel. In some embodiments, the external feature 1610 may be an elastomer sleeve as described herein. In some embodiments, the external feature 1610 is similar to or identical to the external feature described herein. In some embodiments, the external feature 1610 may be an elastic sheath. In some embodiments, the external feature may include a distal end 1612 and a proximal end 1614. In some embodiments, the distal end 1612 is expandable in response to the passage of an instrument or other object through the external feature 1610. In some embodiments, only a portion of the distal end 1612 is expandable. The proximal end 1614 may be more rigid or elastic than the distal end 1612, such that the proximal end 1614 does not expand, or expands not to the same extent as the distal end 1612. In some embodiments, the proximal end 1614 is configured not to expand at all. In some embodiments, the external feature 1610 has sufficient elasticity to resist bending when tension is applied to the tip of the external feature.

[0122] The surgical system 1600 also includes a wire connector 1630. The wire connector 1630 may be referred to as a rigid skeleton. As seen in Figure 22, the wire connector 1630 is located within the external feature 1610. In some embodiments, the wire connector 1630 has a central orifice through which a tool, wire, light, camera, or other object may pass or be located. In some embodiments, the wire connector 1630 is substantially rigid and does not expand.

[0123] The surgical system 1600 includes a wire 1620. As shown in Figure 22, the wire 1620 is connected to a wire connector 1630. In some embodiments, the wire 1620 is passed through the central orifice of the wire connector 1630 and attached to the wire connector 1630 at the upper portion of the wire connector 1630. In some embodiments, the wire 1620 may be outside the wire connector 1630. In some embodiments, the wire 1620 may be located between the wire connector 1630 and the external feature 1610. In some embodiments, the wire 1620 is connected to the wire connector 1630 such that when the wire 1620 is pulled, the wire connector 1630 bends, thereby causing a bend in the distal end 1612 of the external feature 1610. In some embodiments, the wire 1620 is connected to the wire connector 1630 such that the wire is offset from the central axis of the external feature.

[0124] The surgical system 1600 further includes a camera 1660, which may be similar to or identical to the cameras described herein. As shown in Figure 22, the camera 1660 is positioned within the central orifice of the wire connector 1630. In some embodiments, the camera 1660 is fixed within the central orifice of the wire connector 1630 so that the camera cannot move independently of the wire connector 1630. In some embodiments, the field of view of the camera 1660 changes when the wire 1620 is pulled and the wire connector 1630 is bent.

[0125] The expandable internal channel 1640 is located within the external feature 1610. In some embodiments, the expandable internal channel 1640 is located between the wire connector 1630 and the external feature 1610. In some embodiments, the expandable internal channel 1640 is expandable between a thin configuration and an expanded configuration (as shown in Figure 22). In some embodiments, the expandable internal channel 1640 is made of a flexible material such that the pressure from the wire connector 1630 and the external feature 1610 on the expandable internal channel 1640 causes the expandable internal channel 1640 to become a thin configuration. The expandable internal channel 1640 is configured to accommodate the passage of instruments or objects, such as surgical instruments, through the expandable internal channel 1640. When an instrument or object is pushed into the expandable internal channel 1640, the expandable internal channel 1640 is configured to expand from a thin configuration to an expanded configuration. As a result of the expansion of the expandable internal channel 1640, the external features 1610 also expand in accordance with the expansion of the expandable internal channel 1640.

[0126] In some embodiments, the system 1600 also includes a light source 1690. The light source 1690 may be the same as or identical to other light sources described herein. In some embodiments, the light source 1960 is passed through the central orifice of the wire connector 1630. In some embodiments, the light source 1690 is located adjacent to the wire 1620. In some embodiments, the light source 1690 may be located outside the wire connector 1630. In some embodiments, the light source 1690 is located between the wire connector 1630 and the external feature 1610.

[0127] Figures 23 and 24 show different views of the surgical system 1600 with the wire connector extruded from the external feature 1610. As can be seen in Figure 23, the wire connector 1630 includes a plurality of rib gaps 1634, a plurality of ribs 1636, a tongue portion 1638, a channel gap 1635, and a support 1637.

[0128] In some embodiments, the rib gaps 1634 are referred to as side openings. As shown in Figure 23, multiple rib gaps 1634 may be located along the length of the wire connector member 1630. In some embodiments, the space between adjacent rib gaps 1634 is substantially identical along the length of the wire connector member 1630. In some embodiments, the rib gaps 1634 are formed along the periphery of the wire connector member 1630, extending from a first position 1631 of the wire connector member 1630 and terminating 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, rib gaps 1634 located in the same longitudinal position as the channel gaps 1635 are shorter than the other rib gaps. The rib gaps 1634 beneficially allow the wire connector member 1630 to bend in response to the tension of the wire 1620.

[0129] Multiple ribs 1636 are formed by multiple rib gaps 1634, with each rib 1636 positioned between two adjacent pairs of rib gaps 1634. The multiple ribs 1636 are beneficial in that they allow the wire connector 1630 to bend in response to the tension of the wire 1620, while simultaneously preventing the external features 1610 of the system 1600 from bending.

[0130] A channel gap 1635 is formed in the wire connector member 1630. The channel gap 1635 may also be called a lateral opening. In some embodiments, the channel gap 1635 is formed on the opposite side of the wire 1620. In some embodiments, the channel gap 1635 may have an inclined outer circumference such that the channel gap 1635 is wider near the top of the wire connector member 1630 than at the lower end of the channel gap 1635. In some embodiments, the channel gap 1635 is configured such that a channel, such as the expandable internal channel 1640 described herein, is passed through a central orifice of the wire connector member 1630 and emerges from the channel gap 1635.

[0131] The tongue portion 1638 is located within the channel gap 1635. In some embodiments, the tongue portion 1638 abuts against the central orifice of the wire connector member 1630. In some embodiments, the tongue portion 1638 is configured to contact the opposite side of the wire connector member 1630. In some embodiments, the tongue portion 1638 contacts at least one wire extending through the central orifice of the wire connector member 1630, including 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 portion 1638 is configured to guide the channel being pushed through the central orifice of the wire connector member 1630, so that the channel emerges from the channel gap 1635.

[0132] In some embodiments, the wire connector 1630 further includes a support 1637. As shown in Figure 23, the support 1637 may be located on the upper part of the tongue 1638. In some embodiments, the support 1637 abuts against the central orifice of the wire connector 1630. In some embodiments, the support 1637 secures the camera 1660 and, beneficially, prevents the camera 1660 from being pulled further down within the central orifice of the wire connector 1630.

[0133] Figure 25 shows a perspective view of a surgical system 1600, which includes an expandable internal channel 1640 passed through a wire connector 1630. As seen in Figure 25, the expandable internal channel 1640 rises from the bottom of the wire connector 1630 through a central orifice and is guided by a tongue 1638 until the expandable internal channel 1640 emerges from the channel gap 1635. In some embodiments, the expandable internal channel 1640 may be located outside the wire connector 1630 so as not to pass through the wire connector 1630. In this configuration, the expandable internal channel 1640 may be located adjacent to the wire connector 1630.

[0134] Figures 26 and 27 show a side view of the surgical system 1600 with a portion of the wire connector member 1630 cut out. As can be seen in Figure 26, the camera 1660 may have multiple camera wires 1662 connected to the camera 1660. In some embodiments, the camera wires 1662 provided electrical, data, and / or control commands to the camera 1660. As seen in Figure 26, the camera wires 1662 extend from the camera 1660 to the opposite end of the surgical system 1600 through the central orifice of the wire connector member 1630.

[0135] As shown in Figure 26, the wire 1620 may emerge from the wire port 1622 located near the bottom of the wire connecting member 1630 and be connected to the wire connecting member 1630 at the upper part of the wire connecting member 1630.

[0136] Figures 28 and 29 show the actuator 1700 of the surgical system described herein. The actuator 1700 may also be called a control handle. In some embodiments, the actuator 1700 is located proximal to the endoscope or surgical system. As can be seen in Figures 28 and 29, the actuator 1700 includes an upper cover 1710 and a bottom cover 1715. The upper cover 1710 and the bottom cover 1715 engage with each other and are configured to conceal, or nearly conceal, the contents of the actuator 1700.

[0137] As can be seen in Figures 28 and 29, the actuator 1700 further includes an external port 1720, a wire guide device 1730, and at least one actuator 1740. The external port 1720 is located on the top of the actuator 1700 and is configured to receive an external feature 1610 or an elongated tubular structure as described herein. In some embodiments, the elongated tubular structure includes a feature of the surgical system 1600 as described herein. In some embodiments, the external port 1720 includes a knob 1722. In some embodiments, the knob 1722 is configured to apply pressure to the external feature 1610 passed through the external port 1720. In some embodiments, rotating the knob 1722 in a first direction increases the pressure applied to the external feature 1610, and rotating the knob 1722 in a second direction relieves the pressure applied to the external feature 1610. In some embodiments, if the knob 1722 is positioned so that sufficient pressure is applied to the external feature 1610, the external feature 1610 is prevented from passing further through the external port 1720, thereby setting the length of the external feature 1610 emerging from the external port 1720. In some embodiments, the knob 1722 is positioned so that the pressure applied to the external feature is below a threshold, allowing the external feature to pass further through the external port 1720, thereby increasing or decreasing the length of the external feature emerging from the external port 1720.

[0138] The wire guide device 1730 is connected to an external port 1720 and is configured to receive an external feature 1610 passed through the external port 1720. In some embodiments, only a portion of the external feature 1610 is passed through the wire guide device 1730. As can be seen in Figures 28 and 29, the wire guide device includes at least one slot 1732. The at least one slot 1732 is configured to engage with at least one projection 1712 of the upper cover 1710 or the bottom cover 1715, thereby securing the wire guide device 1730 within the upper cover 1710 or the bottom cover 1715.

[0139] The wire guide device 1730 further includes a separator 1734. The separator 1734 engages with the external feature 1610 and is configured to receive any object, wire, or tool passing through the external feature 1610. As can be 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 guide the wire, object, or tool into one of the openings.

[0140] At least one actuator 1740 is configured to receive an object, instrument, or wire protruding from the opening of the separator 1734. In some embodiments, the first actuator is configured to engage with an object, instrument, or wire emerging from the left opening 1735 of the separator 1734. In some embodiments, the second actuator is configured to engage with an object, instrument, or wire emerging from the right opening 1737 of the separator 1734. In some embodiments, the actuator 1740 is configured so that a user can control various aspects of the surgical system by interacting with the actuator 1740. In some embodiments, the wire 1620 may be passed through the opening of the wire guide device 1730 and attached to the actuator 1740. In some embodiments, by turning the knob 1742 of the actuator 1740, the user can pull the wire 1620 or increase the tension of the wire 1620, thereby bending the wire connecting member 1630 at the other end of the surgical system or endoscope.

[0141] In some embodiments, the actuator 1740 may be further connected to other devices, such as a water source, power supply, or controller, but not limited to these. Wires, objects, or tools may be passed through the actuator and engage with devices connected to the actuator 1740. In some embodiments, a user may control the object, wire, or tool passed through the actuator 1740 by interacting with the device. This disclosure provides, in particular, a single-use or disposable, low-cost electronic endoscope with a variable-morphology distal tip having an articulated internal structure to facilitate guidance and aiming in surgical procedures. The technology encompasses a variety of forms similar to and different from the specific forms (also referred to as “Embodiments”) for carrying out the invention described herein. The endoscopes described are intended to illustrate some of the possible forms of the technology and are not intended to be a comprehensive disclosure of the entire scope or all features and variations contained herein, nor to limit the scope of the appended claims.

[0142] The described structures and methods are subject to many modifications. For example, the ratio of the length of the endoscopic portion with an expandable or elastomer working channel to the outer diameter of the insertion portion is in the range of about 5:1 to about 1:1, preferably less than about 4:1, and most preferably less than about 2:1.

[0143] In at least some embodiments, the expandable working channel expands without moving the image sensor relative to the optical transmission system. For example, the expandable distal tip may have an elastomer sheath with a substantially non-circular cross-sectional shape when either the working channel or the lavage lumen is expanded. In other endoscopes disclosed, the camera moves slightly in one direction while the tip expands to allow the instrument to pass through. Once the instrument has emerged and expansion is complete, the camera can be readjusted. After passing through the camera, the instrument can be pushed back and forth within a range of motion that does not cause further camera movement.

[0144] The expandable outer sheath, cleaning lumen, and variable-shape working channel can be made from a variety of sterilizable biocompatible polymer materials. Each can be made from a material having a biocompatible elastomer tube, and may be made from the same or different materials. In addition, the cleaning lumen and variable-shape working channel can also be made from biocompatible non-elastomer materials. The expanded working channel can accommodate a tool passage with a circular cross-sectional shape having a diameter equal to at least 50% of the outer diameter of the insertion portion, preferably at least 60% of such insertion portion, and most preferably at least 95% of the insertion portion. When either the cleaning lumen or the working channel is expanded, the outer sheath takes on a substantially non-circular cross-sectional shape.

[0145] The described electronic endoscope is useful for a variety of surgical or therapeutic procedures (e.g., arthroscopy, gallstone treatment, gynecological endoscopy, kidney stone treatment, otolaryngological endoscopy, urological endoscopy). The endoscope described in this disclosure can also be used for many further applications, including arthroscopic joint examinations and surgeries of the hand, shoulder, and knee, as well as surgeries of the bile ducts (related to the liver), airways, ear, nose, throat, lungs, and blood vessels. In fact, the described device is useful for general surgical use. Such disposable endoscopes do not require re-sterilization, and the portion of the endoscope inserted into the patient has an outer diameter of approximately 2 mm or less, which can provide good visibility in a relatively small package. This makes it easier for general practitioners to use therapeutic endoscopes on an outpatient basis in their clinics, avoiding the delays and costs associated with scheduling procedures that occur in hospital operating rooms.

[0146] Endoscope and internal channels The above disclosure relates to various types of endoscopes. An electronic endoscope may have a hub that remains outside the patient's body. The hub is used by the physician to manipulate the endoscope. An elongated, flexible shaft extends from the hub. This is the portion of the endoscope that can be inserted into the patient's body. The expandable tip extends from the end of the shaft furthest from the hub. This is the distal tip. This expandable distal tip has a sensor that allows the physician to observe inside the patient's body and a working channel that allows the physician to treat or operate on surrounding structures. In particular, a complementary metal-oxide-semiconductor (CMOS) image sensor is located within the distal tip to have a field of view outside the endoscope, although other sensors may also be used. One or more illumination fibers within the distal tip emit light within the field of view of the image sensor. The distal tip may have a variable-shape working channel. A working channel allows one or more tools (e.g., removal devices, cannulas, dislodgers, electrodes, forceps, grippers, knot pushers, laser fibers, needle holders, suction and cleaning devices, trocars, and other tools) to pass through the endoscope from the hub to the forward view of the image sensor. A variable-morphology working channel can change shape to allow tools to pass alongside the image sensor. For example, an expandable working channel can change from a substantially non-circular cross-sectional shape to different enlarged cross-sectional shapes that allow the passage of tools.

[0147] Some endoscopes have a hub that houses the light source. The physician uses the hub to operate the endoscope. The insertion section extends from the hub. At the tip of the endoscope (farthest from the hub), the insertion section has an expandable outer sheath. An optical transmission system transmits light from the hub and across the distal tip to the object being illuminated. An image sensor is located approximately in the center of the distal tip of the endoscope. The sensor captures an image of the illuminated object. A variable-morph working channel may extend from the hub to the distal tip of the endoscope. The working channel is located inside the expandable outer sheath. The low-profile configuration of the working channel fits within the space defined between the image sensor and the expandable outer sheath. The expanded-morph configuration of the working channel allows the instrument to pass the image sensor and exit from the distal tip. When the working channel is in the expanded-morph configuration, the expandable outer sheath has a substantially non-circular shape at the distal tip.

[0148] Some endoscopes have a proximal end closest to the physician and a distal end on the opposite end, with the field of view at the distal end. The hub is located at the proximal end. The portion of the endoscope extending from the hub toward the distal end can be called the “insertion section.” Depending on the physician’s needs, part or all of the insertion section can be inserted into the patient. The hub remains outside the patient’s body. The expandable distal tip extends from the insertion section to the distal end and has a sensor configured to capture images within the field of view. The working channel, lavage lumen, and light guide (e.g., one or more optical fibers) extend within the insertion section from the hub toward the distal end. At a certain point along the insertion section, the endoscope has a cross-section that includes the lavage lumen, light guide, a roughly circular cross-section of the working channel, and a cable extending from the sensor to the hub. At a different point along the distal tip, the cross-section of the endoscope is different. In that different cross-section, there is an image sensor, a working channel, a lavage lumen, and a light guide. Both the working channel and the lavage lumen are morphologically adjustable and can be modified independently of each other. Each can take on a nearly non-circular, thin configuration. Each can also take on an enlarged form to accommodate the passage of a tool through the working channel or the passage of a liquid through the cleaning lumen.

[0149] The endoscope described here has an expandable distal tip, a variable-morphology working channel, and an optionally expandable secondary lumen (e.g., for irrigation). The materials from which these three structures are made may be the same or different. All three structures can be fabricated using biocompatible elastomer materials (e.g., silicone rubber, thermoplastic elastomer (TPE)). TPEs include copolyester elastomers (e.g., Alnitel® from DSM), polyether block amides (e.g., Pebax® from Arkema), polyether polyester block copolymers (e.g., Hytrel® from DuPont), polyolefin elastomers (e.g., ENGAGE® from Dow Chemical), polyurethane elastomers (e.g., PELLETHANE® from Dow Chemical), styrene block copolymers (e.g., EVOPRENE® from AlphaGary), styrene-butadiene block copolymers (e.g., STYROFLEX® from BASF), styrene-ethylene-butylene-styrene block copolymers (e.g., Kraton® from Kraton Polymers), and thermoplastic vulcanized materials (e.g., Santoprene® and GEOLAST® from ExxonMobil).

[0150] The working channel and optional irrigation lumen can also be fabricated from non-elastomer materials and can be modified from thin to enlarged configurations (e.g., poly(ethylene-vinyl acetate) (PEVA), polyimide, polytetrafluoroethylene (PTFE), or polyvinyl chloride (PVC)). A more durable and robust polymer material may be suitable as a relatively rigid tool passes through the working channel, while the distal tip needs to accommodate an enlarged working channel and / or enlarged irrigation lumen.

[0151] The internal channel (e.g., the working channel) may have a thin profile. For example, the thin working channel of a 2mm endoscope has a diameter of 0.5mm within the shaft and a more compact profile at the distal tip to fit within the space between the expandable outer cover, the articulated tip, and the camera. The thin working channel may have a roughly crescent-shaped cross-section. The ends of the crescent-shaped cross-section can be rounded or more sharply bent. Other shapes are also possible, including circular, kidney-shaped, rectangular, and elliptical shapes.

[0152] The internal channel (e.g., the working channel) may also have an enlarged configuration to allow the instrument to pass through the camera when guided by the articulated tip. For example, the enlarged working channel of a 2mm endoscope can be large enough to allow an instrument with an outer diameter of approximately 1.2mm to pass through.

[0153] The channels within the shaft (e.g., working channels, secondary channels, stylet channels, and / or cleaning channels) can be made from non-elastomer polymer materials (e.g., poly(ethylene-vinyl acetate) (PEVA), polyimide, polytetrafluoroethylene (PTFE), polyvinyl chloride (PVC)) or biocompatible elastomer tubing (e.g., latex rubber, silicone rubber, or various USP Class 6 compliant TPEs).

[0154] The cleaning fluid can pass through a secondary channel, which can be called a cleaning channel. The cleaning channel can have any cross-sectional shape within the shaft 3, as long as it can allow sufficient fluid to flow through. The channel can be made from an elastomer tube of a single length. Alternatively, the proximal portion of the cleaning channel within the shaft can be made from a non-elastomer material (e.g., polyimide tube) and connected to the elastomer tip section.

[0155] The secondary channel can be used for the stylet. The stylet channel allows the stylet (not shown) to be introduced into the endoscope, which is typically an elongated metal probe. Introducing the stylet provides additional rigidity, which facilitates proper positioning of the distal tip of the endoscope within the patient's body. In addition, the stylet can give the endoscope a specific shape (e.g., a specific curve or bend). The stylet channel must withstand puncture by the tip of the stylet. Reinforcement is optional. This stylet channel can be made from various polymer tubing materials such as PEVA, polyimide, PTFE, or PVC. Although the stylet channel 27 is shown to have a circular shape, it can have any shape through which the stylet can pass. The stylet channel may have a thin-walled tube, similar to those described above for other working channels, such as polyimide, PTFE, or other tubing. Such channels may have a durable stopper at their distal end, such as a plug made of rigid plastic like acrylic or ABS, or other material that can be bonded to or mechanically secured to the stylet channel, intended to prevent the stylet from puncturing or damaging other parts. If the tip of the stylet is rounded, the end of the tube can also be crimped or bent to form a stopper. This can be used in addition to, or instead of, a rigid plastic plug.

[0156] In some embodiments, a control wire, such as the tension wire 1013 in Figure 10, is included. Such a feature may have a dedicated channel or may be incorporated during the manufacturing process, thus eliminating the need for a separate channel for later introduction into the surgical site. In some embodiments, the control wire may perform the same or similar functions as those described above for the stylet.

[0157] For any channel having a different material along its distal length than the material along its proximal length (e.g., a more rigid proximal section and a more elastic distal section that passes through the elastomer sleeve and past the articulated tip and / or camera), a connecting sleeve can be used to join these sections. For example, this may occur when a circular cross-section working channel shaft and an expandable working channel are fabricated by fixing different materials or different tubing sections together. If these are made using a single length of tubing, a connecting sleeve may not be used. Unlike outer sheath connecting sleeves (which can fit inside the outer cover of an expandable tip cover) and flexible braided sheath covers (which can maintain a uniform outer diameter of the endoscope), a working channel connecting sleeve can be fitted to the outside of the joint between a circular cross-section working channel shaft and an expandable working channel section, maintaining a consistent inner diameter during instrument insertion and removal. The connecting sleeve can be a short piece of thin-walled polymer tubing (e.g., 4-5 mm thick polyimide tubing with a wall thickness of 0.254 mm from Putnam Plastics or Vention Medical).

[0158] Endoscopy and internal support The articulated tips described herein can perform support, guidance, protection, and other functions. They are rigid and elastic and can be bent in a reproducible manner without breakage by pulling a control wire. In some embodiments, the tips can strongly resist bending beyond a point where they cannot elastically return to their original shape or configuration. For example, this occurs when a rib makes contact, thereby supporting the spine portion and preventing further bending in a given direction.

[0159] Materials and radiopaqueness The articulated tip can be formed from a sintered material such as Ti-6AL-4V and / or a similar material. The articulated tip may have the structure, dimensions, and features shown in Figures 1 to 14.

[0160] Internal support structures, such as those described in this application, may have multiple roles and advantages. These can each be enhanced using materials or combinations of materials. For example, an articulated tip may be constructed from a material having the strength and rigidity necessary to perform its support and guiding functions. Titanium, stainless steel, and similar materials can provide such properties (e.g., Ti-6AL-4V). Stainless steel can also provide strength and rigidity for the purposes described herein.

[0161] Further roles and benefits relate to radiopaqueness, or the ease with which materials can be tracked or observed using X-rays or other guidance techniques. For example, during surgery, surgeons can use information obtained from outside the patient's body to obtain visual cues regarding the position and orientation of surgical instruments within the patient's body. X-ray machines or similar tissue-penetrating imaging techniques, sometimes in combination, can be used to improve surgical outcomes. To improve this process, access devices such as endoscopes may include one or more parts that are radiopaque or block the relevant types of radiation. For example, part or all of an articulated tip, as shown in Figures 1 to 14, may be formed from radiopaque material and thus visualized using an X-ray microscope during surgical procedures. This external image can be combined with an internal image (i.e., an image from a tiny internal camera located at the end of the articulated tip), allowing the surgeon to also visualize the internal conditions within the immediate surgical zone.

[0162] In some embodiments (see, for example, Figures 7 and 10 as illustrative examples), the control wire can be radiopaque or partially radiopaque. For example, the enlarged tip 1011 (see Figure 10) can be radiopaque. This can occur, for example, by the welding process when using welding material to fix the control wire to the distal end of an articulated structure. If the welding material is more radiopaque than other materials, it can form a localizable mass of material that aids in surgical control and recognition. If the surgeon knows that this mass is located at a known distance behind the anterior edge of the endoscope (e.g., the camera), this offset can be taken into account. In some embodiments, even if the control wire is completely radiopaque (e.g., formed from stainless steel piano wire), it may be less visible on X-rays than its bulbous end. Using a laser welding process, for example, a stainless steel control wire can be welded to titanium or other rigid material to form an articulated tip. In some cases, platinum materials (which may be denser than gold) are radiopaque and can be used to form part or all of an articulated toe, or to be connected to or fused to it. For example, platinum coatings, rings, or bands can be added to the proximal or distal end of an endoskeleton structure.

[0163] In some cases, one or more radiopaque sections can be formed within or on the articulated tip. For example, if the radiopaque properties of the titanium material are insufficient, a radiopaque coating can be applied. Multiple radiopaque sections or markings can work together to provide the surgeon with information regarding the orientation and position of the surgical instrument or endoscope. For example, an elongated structure such as the articulated tip shown in Figures 1 to 14 may have radiopaque sections at the front and rear. If the X-rays show that the two sections are spaced apart as expected, the instrument is oriented approximately parallel to the X-ray machine. If the X-rays show that the two sections are closer together, the X-ray machine may be oriented more forward or backward (for example, so that the instrument is pointing inside or outside the patient's body from the perspective of the X-ray machine). Similarly, the radiopaque sections may have a directional shape, such as an arrow, which may allow the surgeon to determine the direction in which the endoscope is pointing. In some embodiments, the two radiopaque portions (e.g., anterior and posterior markers) may have different sizes in the X-ray image, thereby helping the surgeon determine orientation and direction.

[0164] Laser and ultrasound The endoscopes and related methods described are well suited for use with lasers and / or ultrasound. For example, the laser can be positioned at the illumination location (see, for example, the tip of the optical fiber indicated as 1266 in Figure 12) or similarly configured to be aimed in the same direction as the camera. Lasers can be used to cut or excise tissue, remove unwanted material, open passages, etc. Lasers can be used for partial excision of the vocal cords, lithotripsy (breaking up stones in part of the kidney or ureter), removal, shaping, and cutting of spinal material (e.g., herniated discs), and similar procedures. In these surgical situations, some assume that lasers are for therapeutic indications and ultrasound for diagnostic purposes, but ultrasound can also be used therapeutically. For example, ultrasound can be used to activate drugs. Ultrasound can also be used to perform some of the functions described for lasers, such as removal of unwanted tissue and opening passages (though potentially more slowly and gently).

[0165] Therefore, lasers and ultrasounds can be used together or in similar roles and can be incorporated into an endoscope as part of the endoscopic device body or as surgical instruments passing through one or more working channels. In some embodiments, one or more of these techniques can also be used externally (e.g., when ultrasound is used for visualization along with or as an alternative to X-ray technology). Resection devices such as lasers may be particularly useful when combined with the disclosed articulated tip, for example, because a control wire can assist in positioning and aiming both the camera and the laser tip. For example, if the camera reveals that a portion of unwanted tissue is slightly off-center from the field of view (this may correspond, for example, to the target zone of a laser), the articulated tip can be arched or bent by twisting the endoscope around its elongated axis while simultaneously pulling the control wire, thereby directing or aiming the camera and laser in the desired lateral direction. Thus, the directionality and precise control enabled by the articulated tip may be particularly beneficial in lasers and similar aiming techniques, resection, or otherwise.

[0166] Endoscopy and infection Arthroscopic surgery can carry life-threatening risks. General anesthesia, while carrying associated risks, can be used, especially in more interventional arthroscopic procedures. Physicians can use sterile techniques and equipment to prevent accidental patient infections. These risks cannot be taken lightly. Ronald Reagan UCLA Medical Center is a leader in implementing the latest minimally invasive endoscopic procedures. In February 2015, 179 people at the hospital were exposed to drug-resistant bacteria during endoscopic procedures. According to reports, seven of them became infected with methicillin-resistant Staphylococcus aureus (MRSA), and two of them died.

[0167] The U.S. Food and Drug Administration has issued a general warning to all healthcare providers regarding the use of medical endoscopes in complex endoscopic procedures. The complex design of some endoscopes hinders the ability to clean, disinfect, and sterilize these reusable devices. Some endoscopes have numerous drawbacks, including very high initial costs and the need for sterilization after each use. Such sterilization procedures are time-consuming and costly. Therefore, simpler or more sterilizable (e.g., single-use) devices have clear advantages.

[0168] For single-use endoscopes, sterilization by the manufacturer can be performed in a single process (e.g., using ethylene oxide gas, gamma rays, or steam). In single-use devices, tube connections abut each other, but small cracks, gaps, or voids may still occur at the joints. Materials suitable for bulk sterilization with ethylene oxide gas, etc., can also be used in the construction of endoscopes without considering the need for the material to withstand multiple exposures to sterilizing chemicals such as glutaraldehyde.

[0169] Endoscope coating and sealing A coating (not shown) can be applied to the outside of an endoscope. For example, such a coating can provide antibacterial or antimicrobial properties (e.g., copper ions, silver ions). The coating can also be used to enable physicians to detect certain medical conditions. For example, special peptides and other formulations can be applied to detect bacterial contamination or the presence of other types of biomarkers.

[0170] To seal the distal tip of the endoscope, a UV-curing adhesive potting compound is applied to the distal tip and allowed to flow between the parts while still viscous. Excess potting compound is removed, and the material is cured or solidified by UV light. Other materials, such as two-part epoxy, may also be used. The application of the potting compound may be limited to areas that do not interfere with the expandable distal tip section (e.g., by a fixture that limits the distribution area of ​​the compound), and / or materials that do not adhere to those expandable sections may be used.

[0171] Endoscope camera A biocompatible and waterproof CMOS color camera can be used in the endoscope. The camera preferably provides a field of view outside the endoscope. The forward field of view extends beyond the distal tip of the endoscope. However, the field of view may be at an angle inclined outwards from the endoscope (e.g., an endoscope oriented at a shifted angle, such as 30 degrees). The CMOS image sensor includes a multi-element lens assembly or a gradient refractive index (GRIN) lens that provides a field of view of 30 to 180 degrees, preferably 50 to 130 degrees, and most preferably 60 to 120 degrees. The effective image resolution is preferably at least 10,000 pixels, more preferably at least 40,000 pixels, and most preferably at least 60,000 pixels, but image resolutions of 1 megapixel or more are also possible. Other sensors that provide sufficient image resolution can be used instead of or in combination with the CMOS device. For example, a charge-coupled device (CCD) can be used.

[0172] Optionally, an optical prism can be added to modify the specific angular field of 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 degrees or 70 degrees. The prism can be made of glass or any transparent polymer such as acrylic or polycarbonate. The prism can be bonded to the flat distal surface of the camera using optically transparent epoxy. More preferably, the prism can replace the final camera lens at the device manufacturer.

[0173] The camera sensor can be further secured to the endoscope structure. The camera sensor can be directly attached to the light guide to provide additional support. The camera cable can be bonded to the sheath cover, the working channel, or both. For example, the camera cable can be bonded to the inside of the sheath cover just proximal to the expandable distal tip section. These additional connections further increase rigidity.

[0174] Endoscope and illumination The endoscope can use an LED surface-mount chip, with the proximal end of the illumination fiber mounted flush with the LED's light-emitting surface area (e.g., within a hub or other proximal portion). Non-LED illumination sources can also be used (e.g., halogen incandescent lamps, xenon light, diode lasers), as long as the selected illumination can be captured by the camera or sensor. Epoxy provides a secure mounting, but other methods may be more appropriate.

[0175] PCA circuits can control the illumination intensity of a light source and operate a camera. PCA circuits can convert signals to and from external control / display. These circuits convert signals into patterns, voltages, timings, etc., required by or transmitted by the camera and used as the illumination source. Such conversions may include converting signals to the Universal Serial Bus (USB) standard. Multilayer or stacked multilayer circuits with embedded software (e.g., firmware) and field-programmable logic arrays (FPGAs) convert and communicate signals.

[0176] If wireless communication is required (whether RF, infrared, or another communication method), the PCA may include a wireless transceiver and a power supply (e.g., a battery). The battery can supply power to the PCA and the image sensor. The wireless transceiver can interface with external control and display devices. For example, the PCA can wirelessly transmit image signals from the image sensor to an external display.

[0177] Alternatively, signal conversion can be performed outside the endoscope. In this case, the PCA can function as an interconnect, routing the signals to a cable, which can then be connected to an external control / display unit.

[0178] Within the hub, numerous LEDs and illumination fibers or fiber bundles can be arranged to ensure sufficient illumination intensity to achieve the desired field of view and depth of field. If the LEDs are small enough, they can be mounted adjacent to the camera within the expandable tip section. Illumination fibers can be routed from the LEDs to reach the outside of the camera at the distal tip. Such illumination subassemblies can be rigid.

[0179] The illumination subassembly is modifiable as long as it provides sufficient illumination intensity to achieve the desired field of view and depth of field. For example, a molded light guide can be used instead of optical illumination fibers, as long as the numerical aperture and illumination field pattern of the light emitted from the light guide are compatible with the camera's field of view. The LEDs can be mounted within the shaft section rather than within the hub enclosure, or they may be located outside the endoscope. [Examples]

[0180] The following examples are provided to illustrate the described technology and are not intended to limit the scope of the attached claims in any way.

[0181] Example 1

[0182] This is a 2mm endoscope with an expandable working channel and an LED light source in the hub, and is formed as follows: Two injection-molded ABS parts 6 and 7 (manufactured by Dow Chemical) form the hub enclosure.

[0183] The USB connector cable assembly (Molex Connector) is inserted into the strain relief tube, and then into the proximal opening of the proximal hub enclosure. The strain relief tube is an injection-molded part made of Shore A60 TPE. The cable assembly is electrically connected to the printed circuit assembly (PCA).

[0184] The PCA is a small, multilayer printed circuit board that incorporates surface-mount integrated circuits and converts USB signals and communications to the camera to the signal levels and timings required by the camera specifications. The PCA is secured to the proximal hub enclosure using four screws.

[0185] The proximal hub enclosure has an opening for the work channel. The work channel connector provides a fluid-tight seal between the proximal hub enclosure and the work channel. Insert the connector (a commercially available Luer Lock® locking component) into the proximal hub enclosure.

[0186] The sheath cover is a 29.2 cm long braided stainless steel reinforced polyimide tube (Putnam Plastics catalog number 142-0045; outer diameter 1.88 mm, inner diameter 1.689 mm).

[0187] The distal strain relief tube is an injection-molded part made of Shore A60 TPE. This tube is inserted through the opening of the hub enclosure. The sheath cover is slid through the distal strain relief to access the inside of the hub enclosure. The sheath cover is secured to the distal strain relief tube by solvent bonding using cyclohexanone.

[0188] The outer sheath is formed from polyimide and silicone tubing using a manufacturing mandrel. A thin-walled polyimide connecting tube with an outer diameter (OD) of approximately 1.689 mm is slid onto a mandrel of the appropriate size. Next, a silicone rubber tube (forming an expandable distal tip cover) with an inner diameter of approximately 1.689 mm and a length of 8 mm, and the sheath / cover assembly are slid onto the mandrel from both ends until they abut each other on the polyimide connecting tube. The silicone rubber tube, polyimide connecting tube, and stainless steel reinforced polyimide tube are bonded with cyclohexanone to form a durable joint.

[0189] The working channel is also formed using a mandrel. A 29.2 cm long polyimide tube 28 (Vention Medical, catalog number 141-0083; outer diameter 0.0505 inches, inner diameter 0.048 inches) is slid onto a mandrel of the appropriate diameter. An 8 mm long USP Class 6 TPE tube (Kraton Polymers, Kraton) is slid onto the mandrel so that it abuts against the polyimide tube 28. The resulting joint is covered with a thin-walled polyimide connecting sleeve 35 (Vention Medical). These components are joined with a low-viscosity UV-curing adhesive (208-CTH-F flexible water-resistant catheter adhesive, Dymax). The working channel assembly 23 / 28 / 35 has a total length of 30 cm.

[0190] Slide the work channel assembly into the outer sheath and the pre-constructed cover assembly. Connect the proximal end of the work channel assembly to the work channel connector. The cyclohexanone solvent adheres the proximal end of the work channel to the connector.

[0191] The camera is mounted to the PCA. The camera is a micro ScoutCam™ 1.2 (Medigas, Omer, Israel). This camera is cylindrical with a diameter of 1.2 mm and a length of 5 mm, and has an effective image resolution of approximately 44,880 pixels. The camera cable 29 extends from the camera and runs through the cover assembly, along the outside of the assembled work channel, and connects to the PCA 61 with a camera connector. The PCA 61 controls the camera and receives images from the camera.

[0192] Three light illumination fibers (Lighthouse LEDs with an outer diameter of 0.25 mm, catalog number 0.25MMFIBERENDGLOW) also extend within the cover assembly along the outside of the work channel assembly until adjacent to the camera. The proximal ends of the illumination fibers 25 are bonded to the light source, a Luxeon® C power LED (Philips Lumileds Lighting), using UV-curing adhesive (Dymax 208-CTH-F adhesive).

[0193] The related parts are passed through the articulated tip.

[0194] Seal the tip and bond the parts with Dynamax. Slide the distal hub enclosure onto the cover / work channel assembly. The distal and proximal hub enclosures snap into place. Heat seal them together to obtain a liquid-tight seal.

[0195] This endoscope has a working length of 30 cm, an outer diameter of 2 mm, and features a variable-shaped distal tip and working channel. Such an endoscope can be used for a variety of endoscopic applications, including arthroscopic joint examinations and surgeries of the hand, shoulder, knee, etc. The endoscope described herein can be used for many other applications, including orthopedics, biliary tract (related to the liver), airway, urology, otolaryngology, lung, and vascular systems. In fact, the described device is useful for general surgical use.

[0196] Example 2

[0197] This endoscope is similar to the one described in Example 1, but is formed with a variable-shape irrigation lumen in addition to a variable-shape working channel. A 30 cm long TPE tube (Vention Medical's Pebax® tube, catalog numbers 115-1289; inner diameter 0.279 mm, wall thickness 0.1143 mm, outer diameter 0.51 mm, Shore A63) forms the irrigation lumen. The process for fabricating the endoscope is the same as in Example 1. The differences are described below.

[0198] Place the Pebax® tube adjacent to the work channel assembly and push the proximal end of the tube onto the return that mates with the Luer Lock® locking connector. This secures the lavage lumen to the proximal hub enclosure. Before sealing the tip, position the distal end of the lavage lumen tube adjacent to the camera in the expandable tip.

[0199] Example 3

[0200] This endoscope is similar to the one described in Example 2, but differs in that the lavage lumen is made from a non-expandable material. Instead of Pebax® tubing, the lavage lumen is made from polyimide tubing (Vention Medical, catalog number 141-0023; outer diameter 0.508 mm, inner diameter 0.457 mm).

[0201] Although the material itself is not expandable, the lavage lumen is manufactured to have its characteristics. At the distal end, an 8 mm long polyimide tube is heat-pressed to form a fold and a flat end. This allows the polyimide tube to bend around the camera inside the expandable outer cover. The proximal end of the polyimide tube is placed on a barbed connector of a commercially available connector 8 (Luer lock® component) and fixed with methyl ethyl ketone solvent.

[0202] During use, as the fluid passes through the cleaning lumen, the folded, flat distal tip of the cleaning lumen expands. Consequently, the outer cover expands as well.

[0203] Example 4

[0204] This is an endoscope similar to the one described in Example 1, configured to wirelessly communicate with an external display and control device (e.g., a PC or tablet computer). The PCA has wireless transceiver components. A commonly available button cell battery is included in the hub assembly to power the PCA. An antenna wire is included and attached to the PCA. A switch is connected in series with the battery. The battery provides enough power for the endoscope system to function for several hours.

[0205] Example 5

[0206] This endoscope is similar to that described in Example 1, but differs in that the expandable working channel is a 30 cm long, unreinforced polyimide tube (Vention Medical, catalog no. 141-0083, outer diameter 1.283 mm, inner diameter 1.219 mm). As described in Example 3 above, an 8 mm long polyimide tube is heat-sealed at the distal end to form a fold and a flat end. This allows the polyimide tube to bend around the camera inside the expandable outer cover. When an instrument or other object is pushed into the working channel, the folded, flat distal end expands, and the outer cover expands accordingly to allow the instrument or other object to pass through.

[0207] In addition, in this example, the camera is an Awaiba NanEye camera (manufactured by AWAIBA). This camera measures 1.1 mm × 1.1 mm × 1.7 mm in length, has a diagonal length of 1.41 mm, and has an effective image resolution of approximately 62,500 pixels. Figure 2c shows a cross-sectional view of this endoscope at its distal tip.

[0208] Example 6

[0209] This endoscope is similar to the one described in Example 1, but differs in that its outer diameter is 1.7 mm.

[0210] The outer sheath is formed from a 29.2 cm long braided stainless steel reinforced polyimide tube (Vention Medical, catalog number 142-0042, outer diameter 1.72 mm, inner diameter 1.57 mm), an 8 mm long silicone rubber tube with an inner diameter of approximately 1.689 mm, and a thin-walled polyimide connecting tube with an outer diameter of approximately 1.689 mm.

[0211] The working channel is formed from a thin-walled polyurethane tube (Vention Medical, catalog number 115-0565; outer diameter 1.346 mm, wall 0.089 mm, inner diameter 1.168 mm).

[0212] The camera is the NanEye camera described in Example 5. The illumination light guide (optical fiber) has an outer diameter of 0.125 mm (core diameter 0.1 mm, Edmund Optics, part number 57-061), and a total of eight fibers are used for illumination. Four conductor cables from the NanEye camera are connected to the PCA for signal connection to a cable suitable for external use, and the PCA includes possible signal processing circuitry to convert the signal to USB standard or other required configurations. The PCA has memory containing calibration information for the specific NanEye camera in use.

[0213] In each of the embodiments described above, further steps relating to the creation, assembly, positioning, and deployment of the articulated tip shown in Figures 1 to 14 may be added. This articulated tip can be used to more effectively aim or position a camera and associated light source by bending it laterally from an initial, more linear position, for example, using a tension wire (see tension wire 1013 in Figure 10).

[0214] Embodiments of the present invention The following clauses describe specific aspects of the invention relating to this disclosure.

[0215] Clause 1. Endoscope hybrid tip comprising: an expandable internal channel; an endoskeleton having an elongated base, at least two ribs extending therefrom, and groove passages adjacent to the base and ribs, configured to allow at least one expandable channel to pass through; an elastic outer layer configured to surround the endoskeleton and the expandable internal channel; and an expandable internal channel, endoskeleton, and elastic outer layer configured such that when a surgical instrument passes through the expandable internal channel, the instrument pushes the endoskeleton, expanding both the expandable internal channel and the elastic outer layer outward, thereby bypassing the endoskeleton and reaching the surgical site beyond the endoscope.

[0216] Clause 2. The endoscopic hybrid tip according to Clause 1, wherein the endoskeleton has at least three ribs extending from an elongated base at proximal, intermediate, and distal rib attachment locations, and the elongated base has at least two flexible sections located between the rib attachment locations.

[0217] Clause 3. The endoscopic hybrid tip as described in Clause 2, wherein two of the three ribs are configured to allow an expandable channel and any surgical instrument extending through it to pass adjacent to at least two ribs without altering its trajectory, and the third rib is configured to guide the expandable channel and any surgical instrument extending through it to alter its trajectory.

[0218] Clause 4. The endoscopic hybrid tip as described in Clause 3, wherein the third rib has an internal space configured to surround and support the camera and light source, and when the third rib structure guides and alters the trajectory of the expandable channel and any surgical instrument extending through it, the expandable channel and any surgical instrument extending through it bypass the camera and light source, and the surgical instrument extends into the camera's field of view.

[0219] Clause 5. Each rib includes a passage for a control wire, as described in Clause 1, for the endoscope hybrid tip.

[0220] Clause 6. The endoscopic hybrid tip as described in Clause 5, wherein one of the ribs is a distal rib, and the distal end of the passage is provided with a control wire engagement portion configured to engage firmly with a portion of the control wire, so that when the control wire is pulled proximal, the ribs move closer together and the elongated base bends.

[0221] Clause 7. A camera adjacent to and mechanically connected to a distal rib, wherein the camera aims laterally by bending of an elongated base, as described in Clause 6.

[0222] Clause 8. The endoscope hybrid tip as described in Clause 7, further comprising a laser that can be aimed using a control wire so as to be able to excise or illuminate tissue within the field of view of the camera.

[0223] Clause 9. Endoscopic surgical system comprising: an endoscope having a hub, a shaft having an elongated axis and width, and a working tip at the distal end of the shaft; an energy source configured to supply optical energy through an optical fiber cable extending through the shaft to the working tip; a camera system comprising a working channel extending continuously from the hub through the shaft to the tip, a connector cable in the shaft, and a camera box at the working tip; an elastic layer outside the working tip; and a support structure inside the working tip, the support structure configured to position the camera box and the emission portion of the energy source both facing distally outward from the working tip toward the working zone, and to facilitate the passage of surgical instruments through the working channel at the tip by using a series of hard surfaces to laterally displace the anterior edge of any such instrument so that the anterior edge of the surgical instrument bypasses the camera box, stretches the elastic layer laterally, and protrudes from the working channel into the working zone.

[0224] Clause 10. The system according to Clause 9, comprising an articulated rigid structure having an elongated dorsal portion substantially aligned with the elongated axis of the shaft; a proximal attachment supported by the dorsal portion and configured such that each of the fiber optic cables, work channels, and connector cables of the camera system can extend longitudinally thereon; a central attachment supported by the dorsal portion and configured such that each of the fiber optic cables, work channels, and connector cables of the camera system can extend longitudinally thereon; and a distal attachment supported by the dorsal portion and configured to align the sights of the camera box and the emission portion of the energy source toward the work zone.

[0225] Clause 11. The system according to Clause 10, wherein the distal attachment comprises a camera holder and a deflector configured to function as one or more of the hard surfaces.

[0226] Clause 12. The support structure is configured for controlled bending, as described in Clause 9.

[0227] Clause 13. The system according to Clause 12, wherein the elongated dorsal portion has at least two flexion zones, and the distal appendage is configured to physically interface with a tension cable at a position laterally offset from its central axis.

[0228] The system as described in Clause 14.3, wherein each of the three attachments provides a passage for the tension cable such that when the tension cable is pulled, the elongated back portion bends, the distal attachment approaches the central attachment, and the distal attachment aims the camera box and the energy source discharge portion at a portion of the work zone on the same side as the laterally offset position.

[0229] Clause 15. A method for introducing and aiming a camera, an energy source, and a surgical instrument, the method comprising: providing an elongated 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 elongated shaft; providing an elastic sleeve in a substantially cylindrical space around a rigid support structure; and passing an elongated surgical instrument having a rigid anterior portion through the elongated shaft such that the anterior portion passes within the elastic sleeve adjacent to the articulated support structure, thereby displacing the anterior portion laterally such that the anterior portion stretches the elastic sleeve, bypasses the camera and energy source, and extends within the field of view of the camera and energy source.

[0230] Clause 16. The method of Clause 15, further comprising providing an elongated control device that physically interfaces with an articulated support structure to change the aiming direction of a camera and an energy source.

[0231] Clause 17. The method according to Clause 16, wherein the control device is a tension wire configured to sit at the distal end of an articulated support structure, pass therein in the longitudinal direction, and extend through an elongated shaft away from the surgical site, and the method further comprises changing the aiming direction by pulling the tension wire.

[0232] Clause 18. The method according to Clause 15, further comprising providing a laser as an energy source, supplying energy to the tissue of the surgical site using the laser, transmitting optical information from a camera backward through an elongated shaft, and simultaneously controlling the aiming direction of the camera and laser from the proximal end of the shaft.

[0233] Clause 19. The articulated support structure according to Clause 15, comprising a core and three rib sections, wherein the distal rib section supports and protects the camera, the more proximal rib provides rigidity to the surgical end of the elongated shaft, and the ribs together provide a pathway for any elongated surgical instrument within an elastic sleeve.

[0234] Clause 20. The method of Clause 15, further comprising providing a continuous working channel through an elongated shaft and extending through an elastic sleeve in an articulated support structure, wherein passing an elongated surgical instrument through the elongated shaft includes passing the instrument through the continuous working channel.

[0235] Clause 21. A surgical endoscope system that correlates optical feedback with mechanical control, comprising: a proximal end and a distal end, a control wire extending through them and connected to the distal end, and an elongated tip control structure having a targeting direction aligned with the elongated axis of the elongated tip and guided beyond the distal end; a camera located at the distal end of the tip control structure and configured to target the targeting direction; at least one surgical instrument configured to target from the distal end or to extend from the distal end; an expandable sheath configured to enclose the elongated tip and camera in a tubular manner; and a control wire configured to arch the elongated tip, thereby moving the targeting direction laterally from the initial relaxed targeting direction.

[0236] Clause 22. The system according to Clause 21, wherein the elongated tip control structure has at least three segments: proximal, intermediate, and distal, each having a passage for a control wire, and the control wire passage in the intermediate segment provides a larger lateral space than the passage in the distal segment provides for the control wire.

[0237] Clause 23. The surgical instrument is part of the system described in Clause 21, which includes a working channel configured to also be aimed in the direction of sighting.

[0238] Clause 24. The system according to Clause 21, further comprising at least one working channel that extends within an expandable sheath adjacent to an elongated tip control structure, thereby enabling the expansion of the expandable sheath.

[0239] Clause 25. The system according to Clause 21, wherein the elongated tip control structure has at least one radiopaque portion configured for visibility under radiation outside the patient's body.

[0240] Clause 26. The system according to Clause 25, wherein the radiopaque portion comprises one or more of a control wire and an enlarged mass at the end of the control wire formed from a high-density metallic material.

[0241] Clause 27. The surgical instrument is a system as described in Clause 21, comprising a laser configured to be aimed in the direction of the target.

[0242] Clause 28. The system according to Clause 21, further comprising one or more radiopaque features associated with the elongated tip control structure, which are formed from a different material from the elongated tip control structure, so that the orientation of the elongated tip control structure can be indicated by visualization from radiation outside the patient's body.

[0243] Clause 29. Endoscope hybrid tip comprising: a wire connecting member having a maximum width; a wire attached to the wire connecting member; an expandable internal channel configured to expand beyond the maximum width of the wire connecting member; and an elastic sheath configured to surround the wire connecting member and the expandable internal channel, wherein the elastic sheath is configured to expand in accordance with the expansion of the expandable internal channel.

[0244] Clause 30. The endoscopic hybrid tip according to Clause 29, wherein the wire connecting member is configured to interact with at least one rigid structure within the tip, thereby allowing the wire to change the directional angle of the tip.

[0245] Clause 31. The endoscopic hybrid tip according to Clause 30, wherein at least one rigid structure comprises an elongated spine portion.

[0246] Clause 32. The endoscope hybrid tip according to Clause 30, wherein at least one rigid structure comprises a camera or a light source.

[0247] Clause 33. The wire connecting member is a ring, as described in Clause 29 for the endoscope hybrid tip.

[0248] Clause 34. The wire connecting member is a camera, as described in Clause 29 of the endoscope hybrid tip.

[0249] Clause 35. A steerable endoscope comprising: a control handle having a tension wire handle positioned at the proximal end of the endoscope and configured to increase the tension of an elongated wire extending from a control handle; a working tip having an elongated tubular structure extending from the control handle and having a central axis; a rigid body positioned at the distal end of the elongated tubular structure and attached to the distal end of the elongated wire at a mounting position offset from the central axis; an elongated tubular structure configured to expand outward at the working tip in response to the passage of a surgical instrument as the instrument passes through another rigid structure housed within the working tip; a working channel extending through the elongated tubular structure and configured to expand at the same position and time as the outward expansion at the tip of the elongated tubular structure; and a working tip having sufficient rigidity to resist bending by changing direction when the tension on the tension wire increases, and having sufficient elasticity to allow the expansion and passage of a surgical instrument through the working tip.

[0250] Clause 36. The endoscope according to Clause 35, wherein the working tip comprises at least two rigid articulated members within an elongated tubular structure, configured to extend at least partially around a central axis, and having at least one lateral opening for the passage of surgical instruments and expansion of the working channel.

[0251] Clause 37. The endoscope according to Clause 35, wherein the working tip is equipped with a rigid ring surrounding the camera module, the rigid ring having a mounting position, and the elongated tubular structure and its contents in the working tip provide sufficient rigidity to resist bending when the working tip changes direction due to tension on the wire.

[0252] Clause 38. The endoscope according to Clause 35, wherein the working tip comprises a rigid skeleton having a series of rib components separated by openings on both sides.

[0253] Clause 39. The endoscope according to Clause 38, wherein when the tip is operated using a wire, the rib part separates on one side and compresses on the other side.

[0254] Clause 40. The endoscope according to Clause 39, wherein the rigid skeleton has at least one lateral opening adjacent to the camera.

[0255] Clause 41. The endoscope according to Clause 40, wherein the lateral opening is configured such that a surgical instrument can bulge out from the lateral opening to expand the working channel and bypass the camera.

[0256] The foregoing detailed description includes descriptions of various forms of implementing the present technology and includes many specific examples for illustrative purposes only. Without departing from the spirit and scope of the claims of the present technology, many modifications, changes, substitutions, and alternative forms are possible based on the disclosure and proposals described in this application. Examples are used to illustrate specific embodiments, but the claims are not intended to be limited to these examples; rather, they are intended to cover the entire scope of the claims. Therefore, the foregoing description of the selected embodiments and the following examples are described without losing generality with respect to the described technology and without imposing limitations on the described technology.

[0257] Furthermore, in the foregoing detailed description of the selected embodiments, reference is made to the accompanying drawings that form a part of this specification, and these drawings illustratively show specific embodiments capable of implementing the described technology. Without departing from the scope of the described technology, other embodiments can be utilized and structural changes can be made. For example, the general principles and features illustrated or described as part of one embodiment can be used in another embodiment to result in yet another embodiment without departing from the spirit and scope of the described technology. Therefore, the claims are not limited by the above description. All changes within the meaning and scope of equivalents of the claims shall be included within that scope.

[0258] Those skilled in the art will understand that the processes and methods disclosed herein may be performed in different orders. Furthermore, the steps and operations outlined are provided only as examples, and some steps and operations may be optional, integrated into fewer steps and operations, or extended into additional steps and operations, without compromising the essence of the disclosed embodiments.

[0259] With regard to the use of substantially any plural and / or singular terms herein, those skilled in the art can convert from plural to singular and / or singular to plural as appropriate to the context and / or use. Various singular / plural variations may be explicitly described herein for clarity.

[0260] The terms used herein, and in particular in the appended claims (e.g., the body of the appended claims), are generally intended to be “open” terms. (For example, the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” and the term “includes” should be interpreted as “includes but not limited to,” etc.) A person skilled in the art will further understand that if a particular number is intended in the description of an introduced claim, such intention is explicitly stated in the claim, and if such statement is not made, such intention does not exist. For example, to aid understanding, the following appended claims may include the use of the introductory phrases “at least one” and “one or more” to introduce the description of the claims. However, the use of such phrases should not be interpreted as meaning that the introduction of a claim description with the indefinite article "a" or "an" limits any particular claim containing such introduced description to embodiments containing only one such description, even if the same claim contains the introductory phrase "one or more" or "at least one" and an indefinite article such as "a" or "an" (for example, "a" and / or "an" should be interpreted as meaning "at least one" or "one or more"), and the same applies to the use of definite articles used to introduce the description of a claim. In addition, even if a particular number is explicitly stated in the description of an introduced claim, a person skilled in the art will recognize that such description should be interpreted as meaning at least the number stated (for example, the mere statement "two descriptions," without other modifiers, means at least two descriptions, or two or more descriptions).Furthermore, when a convention similar to "at least one of A, B, and C" is used, such configurations are generally intended in a way that a person skilled in the art would understand the convention (for example, "a system having at least one of A, B, and C" includes, but is not limited to, systems having only A, only B, only C, A and B together, A and C together, B and C together, and / or systems having A, B and C together). When a convention similar to "at least one of A, B, or C" is used, such configurations are generally intended in a way that a person skilled in the art would understand the convention (for example, "a system having at least one of A, B, or C" includes, but is not limited to, systems having only A, only B, only C, A and B together, A and C together, B and C together, and / or systems having A, B and C together). It will be further understood by those skilled in the art that substantially any optional word and / or phrase presenting two or more alternative terms should be understood as construing the possibility of including one of the terms, either of the terms, or both of the terms, whether in the specification, claims, or drawings. For example, the phrase “A or B” is understood to include the possibilities of “A” or “B” or “A and B.”

[0261] If any feature or aspect of this disclosure is described in relation to the Markush group, a person skilled in the art will recognize that this disclosure also describes any individual component or subgroup of components of the Markush group.

[0262] For all purposes, for example, in providing the descriptions provided herein, all scopes disclosed herein also encompass all possible sub-scopes and combinations thereof. Any scope listed can be readily recognized as sufficiently descriptive and enabling the division of the same scope into at least equal halves, thirds, quarters, fifths, tenths, etc. As a non-limiting example, each scope described herein can be readily divided into a lower third, a middle third, an upper third, etc. Also, as will be understood by those skilled in the art, all expressions such as “maximum” and “at least” refer to a scope that includes the number described and is then divisible into sub-scopes as described above. For example, “about 5” includes the number 5. Finally, as will be understood by those skilled in the art, a scope includes its individual components. Thus, for example, a group having 1 to 3 cells refers to a group having 1, 2, or 3 cells. Similarly, a group having 1 to 5 cells refers to a group having 1, 2, 3, 4, or 5 cells, etc.

[0263] For methods disclosed herein, such as methods for performing procedures, corresponding uses are also expressly intended. For example, for methods for performing procedures using an endoscopic system, endoscope, or stylet, corresponding uses of the endoscopic system, endoscope, or stylet in question in the procedure are also conceivable.

[0264] From the foregoing, it will be understood that the various embodiments described herein are illustrative and can be modified in various ways without departing from the scope and spirit of the disclosure. Accordingly, the various embodiments disclosed herein are not intended to be limiting, and the true scope and spirit are shown in the following claims.

Claims

1. Expandable internal channels, It is an endoskeleton, A long, slender core, At least two ribs extend from there, An inner frame having groove passages adjacent to the main body and ribs, configured to allow at least one expandable channel to pass through, An elastic outer layer configured to surround the inner skeleton and the expandable inner channel, The expandable internal channel, endoskeleton, and elastic outer layer are configured such that when a surgical instrument passes through the expandable internal channel, the instrument pushes against the endoskeleton, expanding both the expandable internal channel and the elastic outer layer outward, thereby bypassing the endoskeleton and reaching the surgical site beyond the endoscope. Endoscope hybrid tip equipped with the following features.

2. The endoscope hybrid tip according to claim 1, wherein the endoskeleton has at least three ribs extending from the elongated base at proximal, intermediate, and distal rib attachment positions, and the elongated base has at least two flexible sections located between the rib attachment positions.

3. The endoscope hybrid tip according to claim 2, wherein two of the three ribs are configured to allow the expandable channel and any surgical instrument extending through it to pass adjacent to at least two of the ribs without changing their trajectory, and the third rib is configured to guide the expandable channel and any surgical instrument extending through it to change its trajectory.

4. The endoscope hybrid tip according to claim 3, wherein the third rib has an internal space configured to surround and support a camera and a light source, and when the third rib structure guides and alters the trajectory of the expandable channel and any surgical instrument extending through it, the expandable channel and any surgical instrument extending through it bypass the camera and light source, and the surgical instrument extends into the field of view of the camera.

5. The endoscopic hybrid tip according to claim 1, wherein each of the ribs includes a passage for a control wire.

6. One of the ribs is a distal rib, and the distal end of the passage is provided with a control wire engagement portion configured to firmly engage with a portion of the control wire, so that when the control wire is pulled in the proximal direction, the ribs move closer together and the elongated base bends, as described in claim 5.

7. The endoscope hybrid tip according to claim 6, wherein a camera is adjacent to and mechanically connected to the distal rib, and the camera aims laterally by bending the elongated base.

8. The endoscope hybrid tip according to claim 7, further comprising a laser that can be aimed using the control wire so as to be able to excise or illuminate tissue within the field of view of the camera.

9. An endoscope comprising a hub, a shaft having an elongated axis and width, and a working tip at the distal end of the shaft, An energy source configured to supply optical energy through an optical fiber cable extending from the shaft to the tip of the workpiece, A work channel extending continuously from the hub through the shaft to the tip, A camera system comprising a connector cable inside the shaft and a camera box at the work tip, The elastic layer located outside the aforementioned work tip, The support structure is located inside the aforementioned work tip, and the support structure is, The camera box and the energy source discharge portion are both positioned to face distally outward from the work tip toward the work zone, A support structure is configured to facilitate the passage of a surgical instrument through the work channel at its tip by using a series of rigid surfaces to laterally displace the front edge of any such instrument so that the front edge of the surgical instrument bypasses the camera box, stretches the elastic layer laterally, and protrudes from the work channel into the work zone, An endoscopic surgical system equipped with [specific features / equipment].

10. The aforementioned support structure is The shaft has an elongated back portion that is substantially aligned with the elongated axis, A proximal attachment is supported by the aforementioned back portion and configured such that the optical fiber cable, the work channel, and the connector cable of the camera system can each extend longitudinally thereon, A central attachment is supported by the aforementioned back portion and configured such that the optical fiber cable, the work channel, and the connector cable of the camera system can each extend longitudinally thereby, A distal attachment supported by the aforementioned rear portion and configured to align the camera box and the emission portion of the energy source toward the work zone, The system according to claim 9, comprising an articulated rigid structure having

11. The system according to claim 10, wherein the distal attachment comprises a camera holder and a deflector configured to function as one or more of the hard surfaces.

12. The system according to claim 9, wherein the support structure is configured for controlled bending.

13. The system according to claim 12, wherein the elongated dorsal portion has at least two flexion zones, and the distal attachment is configured to physically interface with a tension cable at a position laterally offset from its central axis.

14. The system according to claim 13, wherein each of the three attachments provides a passage for the tension cable such that when the tension cable is pulled, the elongated back portion bends, the distal attachment approaches the central attachment, and the distal attachment aims the camera box and the emission portion of the energy source at a portion of the work zone on the same side as the laterally offset position.

15. A method for introducing and aiming a camera, an energy source, and surgical instruments, the method being To provide an elongated shaft configured to extend to the surgical site, The camera, energy source, and articulated support structure are positioned at the surgical end of the elongated shaft, An elastic sleeve is provided in the substantially cylindrical space surrounding the aforementioned robust support structure, A slender surgical instrument having a rigid anterior portion is passed through the slender shaft such that the anterior portion passes through the elastic sleeve adjacent to the articulated support structure, thereby displacing the anterior portion laterally so that it stretches the elastic sleeve, bypasses the camera and energy source, and extends within the field of view of the camera and energy source. Methods that include...

16. The method according to claim 15, further comprising providing an elongated control device that physically interfaces with the articulated support structure to change the aiming direction of the camera and energy source.

17. The method according to claim 16, wherein the control device is a tension wire configured to sit at the distal end of the articulated support structure, pass therein in the longitudinal direction, and extend away from the surgical site through the elongated shaft, the method further comprising changing the aiming direction by pulling the tension wire.

18. The method according to claim 15, further comprising: providing a laser as the energy source; supplying energy to the tissue of the surgical site using the laser; transmitting optical information from the camera backward through the elongated shaft; and simultaneously controlling the aiming direction of the camera and the laser from the proximal end of the shaft.

19. The method according to claim 15, wherein the articulated support structure comprises a core and three rib sections, wherein the distal rib section supports and protects the camera, the more proximal rib provides rigidity to the surgical end of the elongated shaft, and the rib, together, provides a pathway for any elongated surgical instrument within the elastic sleeve.

20. The method according to claim 15, further comprising providing a continuous working channel that passes through the elongated shaft and extends through the elastic sleeve in the articulated support structure, wherein passing the elongated surgical instrument through the elongated shaft includes passing the instrument through the continuous working channel.

21. A surgical endoscope system that correlates optical feedback and mechanical control, wherein the system is A proximal end and a distal end, a control wire extending through them and connected to the distal end, and an elongated tip control structure having a targeting direction aligned with the elongated axis of the elongated tip and guided beyond the distal end, A camera located at the distal end of the aforementioned tip control structure and configured to aim in the aiming direction, At least one surgical instrument configured to aim from the distal end or to extend from the distal end, The aforementioned elongated tip and the expandable sheath configured to enclose the camera in a tubular shape, The control wire is configured such that its elongated tip is arched, thereby moving the aiming direction laterally from the initial relaxed aiming direction, A surgical endoscope system that correlates optical feedback with mechanical control.

22. The system according to claim 21, wherein the elongated tip control structure has at least three segments, proximal, intermediate, and distal, each having a passage for the control wire, and the control wire passage in the intermediate segment provides a larger lateral space than the passage in the distal segment provides for the control wire.

23. The system according to claim 21, wherein the surgical instrument is provided with a working channel configured to be aimed in the aiming direction.

24. The system according to claim 21, further comprising at least one working channel adjacent to the elongated tip control structure, which expands within the expandable sheath and thereby allows the expandable sheath to expand.

25. The system according to claim 21, wherein the elongated tip control structure has at least one radiopaque portion configured for visibility under radiation outside the patient's body.

26. The system according to claim 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 high-density metallic material.

27. The system according to claim 21, wherein the surgical instrument comprises a laser configured to aim in the aiming direction.

28. The system according to claim 21, wherein the elongated tip control structure is formed from a material different from the elongated tip control structure and further comprises one or more radiopaque features associated with the elongated tip control structure, so that the orientation of the elongated tip control structure can be indicated by visualization from radiation outside the patient's body.

29. A wire connecting member having the maximum width, The wire attached to the wire connecting member, An expandable internal channel configured to extend beyond the maximum width of the wire connection member, An elastic sheath configured to surround the wire connecting member and the expandable internal channel, wherein the elastic sheath is configured to expand in accordance with the expansion of the expandable internal channel, Endoscope hybrid tip equipped with the following features.

30. The wire connecting member is configured to interact with at least one rigid structure within the tip portion, thereby allowing the wire to change the directional angle of the tip portion, as described in claim 29.

31. The endoscope hybrid tip according to claim 30, wherein the at least one rigid structure comprises an elongated spine portion.

32. The endoscope hybrid tip according to claim 30, wherein the at least one rigid structure comprises a camera or a light source.

33. The wire connecting member is a ring, as described in claim 29, for the endoscope hybrid tip.

34. The wire connecting member is a camera, as described in claim 29.

35. A control handle is provided, which is located at the proximal end of the endoscope and includes a tension wire handle configured to increase the tension of an elongated wire extending from the control handle. An elongated tubular structure extending from the control handle and having a central axis, A working tip portion comprising a rigid body located at the distal end of the elongated tubular structure and attached to the distal end of the elongated wire at a mounting position offset from the central axis, The elongated tubular structure is configured to expand outward at the working tip when the surgical instrument passes through other rigid structures housed within the working tip, A working channel extending through the elongated tubular structure and configured to expand at the same position and time as the outward expansion at the tip of the elongated tubular structure, The work tip, having sufficient rigidity to resist bending by changing direction when the tension on the tension wire increases, and having sufficient elasticity to allow the surgical instrument to expand and pass through the work tip, A steerable endoscope equipped with the following features.

36. The endoscope according to claim 35, wherein the working tip comprises at least two rigid articulated members within the elongated tubular structure, which are configured to extend at least partially around the central axis and have at least one lateral opening for the passage of the surgical instrument and for the expansion of the working channel.

37. The endoscope according to claim 35, wherein the working tip is provided with a rigid ring surrounding a camera module, the rigid ring is provided with the mounting position, and the elongated tubular structure and its contents in the working tip provide sufficient rigidity to resist bending when the working tip changes direction due to tension on the wire.

38. The endoscope according to claim 35, wherein the working tip comprises a rigid skeleton having a series of rib components separated by openings on both sides.

39. The endoscope according to claim 38, wherein when the tip is manipulated using the wire, the rib component is configured to separate on one side and compress on the other side.

40. The endoscope according to claim 39, wherein the rigid frame has at least one lateral opening adjacent to the camera.

41. The endoscope according to claim 40, wherein the lateral opening is configured so that the surgical instrument can expand out of the lateral opening to extend the working channel and bypass the camera.

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