CN118019483A

CN118019483A - Endoscope illumination

Info

Publication number: CN118019483A
Application number: CN202280065507.8A
Authority: CN
Inventors: M·赫达; K·莫汉; S·阿诺德; S·德赛
Original assignee: Psip2 LLC
Current assignee: Psip2 LLC
Priority date: 2021-09-28
Filing date: 2022-09-28
Publication date: 2024-05-10

Abstract

The insertion shaft of the arthroscope has a solid-state camera near its distal end. The shaft has an outer diameter of no more than 6 mm and has rigidity and strength for inserting a camera into a joint for arthroscopic surgery. The optical conductor has a flattened region shaped to lie between the endoscope camera and an inner surface of an outer wall of the endoscope shaft. The flattened area is shaped to conduct illumination light to the distal end of the endoscope shaft via the space between the camera and the inner surface of the other wall to illuminate the surgical cavity to be viewed by the camera. The flattened region is formed by heating a region of the plastic optical fiber and pressing the heated region in a polished die.

Description

Endoscope illumination

Background

The present application claims priority from the following applications: U.S. provisional application No. 63/400,961 entitled "endoscope," filed on 8.25.2022; U.S. application Ser. No. 17/824,857 entitled "endoscope," filed 5/25/2022; and U.S. provisional application No. 63/249,479, entitled "endoscope," filed on 9 and 28 of 2021. The entire disclosure of the parent application is incorporated herein by reference.

The present application relates to endoscopic, laparoscopic, arthroscopic, colonoscopic and similar surgical devices or instruments particularly suitable for or intended for evaluating, examining, measuring, monitoring, studying or testing living or dead human and animal bodies for medical purposes or for use in surgical procedures performed on the body or for preparing surgical procedures, and devices designed to assist in surgical procedures.

Disclosure of Invention

In general, in a first aspect, the invention features an arthroscope. The arthroscope has a handle and an insertion shaft. The insertion shaft has a solid state camera near its distal end. The shaft has at least one light conductor encapsulated therein, the light conductor being designed to conduct illumination light to the distal end. The outer diameter of the shaft is no greater than 6 mm. The shaft has rigidity and strength for inserting the camera into the joint for arthroscopic surgery. The light guide in the region of the camera is designed to conduct illumination light from the optical fiber to the distal end via the space between the camera and the inner surface of the insertion shaft.

In general, in a second aspect, the invention features an optical fiber. The fiber has a flattened region shaped to lie between the endoscope camera and an inner surface of an outer wall of the endoscope shaft and to conduct illumination light to a distal end of the endoscope shaft to illuminate a surgical cavity to be viewed by the camera. The diameter of the shaft does not exceed 6 mm. The flattened region is formed by heating a region of the plastic optical fiber and pressing the heated region in a polished die.

Preferred embodiments may have one or more of the following features. One or more light guides may be designed to conduct illumination light from the optical fiber to the distal end. The light guide may have a cross-section other than circular. The light guide may have a coupler to receive illumination light from a circular cross-section fiber. The cross section of the light guide in the region of the camera is narrower than the diameter of the optical fiber in the dimension of the light guide corresponding to the radius of the insertion axis. At least one of the inner and outer surfaces of the one or more light guides may be longitudinally fluted. The distal surface of the one or more light guides or flattened regions may be designed to diffuse the exiting light. The distal surface of one or more light guides may have surface micro-domes (surface microdomes) designed to diffuse the exiting light, or may be otherwise configured to improve the uniformity of illumination into the surgical cavity for arthroscopic access. One or more of the optical conductors in the region of the camera may be formed as flattened regions of optical fibers. The flattened area may be shaped to lie between the endoscope camera and an inner surface of an outer wall of the endoscope shaft. The flattened area may be shaped to direct illumination light to the distal end of the endoscope shaft to illuminate a surgical cavity to be viewed by the camera. The outer diameter of the shaft may not exceed 6 mm. The flattened region may be formed by heating a region of the plastic optical fiber. The flattened regions may be formed by extruding the optical fibers in a polished die. The components for mounting near the distal end of the endoscope may be shaped using error-proofing (poka-yoke) design principles to ensure proper assembly. The component parts of the lens assembly for mounting near the distal end may be shaped using error-proofing design principles to ensure proper assembly. The component parts near the distal end may be formed to allow adjustment of the focus of the lens assembly during manufacturing. The endoscope may have a terminal window designed to seal with the shaft to prevent intrusion of body fluids, body tissues, and/or infusion fluids. The termination window may be designed to reduce optical artifacts. Artifacts that may be reduced may be reflections, light leakage within the endoscope, contamination by body fluids and/or body tissue, and fogging. The optical conductors in the region of the camera may comprise at least nine substantially continuous diameter optical fibers from the light source, the optical fibers having diameters of no more than about 0.5 millimeters and being arranged opposite (subtend) at least 250 ° of the circumference of the distal end of the endoscope. The arthroscopic insertion shaft may have a solid-state camera near its distal end. The shaft may have a light conductor encapsulated therein, the light conductor being designed to conduct illumination light to the distal end. The shaft may have rigidity and strength for inserting a camera into a joint for arthroscopic surgery. The flattened region may be sized to conduct illumination light from the optical fiber to the distal end via a space between the camera and an inner surface of the insertion shaft.

The foregoing advantages and features are merely representative embodiments and are merely provided to facilitate an understanding of the present invention. It should be understood that they are not to be considered as limiting the invention as defined by the claims. Additional features and advantages of embodiments of the invention will become apparent from the drawings and claims, and from the following description.

Drawings

Fig. 1A to 1H, 2A to 2Q, 3A to 3G, 4C, 4E to 4H, 4N to 4W, 4Z, 4AA to 4GG, 4II to 4MM, 5B, 7A, 7G to 7J, 7N to 7Z, 9B, 9C, 9G, and 9J are perspective views of an endoscope and/or an endoscope-related device.

Fig. 4A, 4X, 4Y, 4HH, 5C, 5G to 5J, 6D, 7B, 7D, 8A to 8E, 9C, 9E to 9I are plan sectional views of an endoscope and/or endoscope-related device.

Fig. 4B, 4I, 4M, 6E, 7M are exploded views of an endoscope and/or endoscope-related device.

Fig. 4D, 4J, 4K, 4L, 5D to 5F, 7C, 7E, 7F, 7K, 7L, 8F, 9A, 9D are perspective cross-sectional or cut-away views of an endoscope and/or an endoscope-related device.

Fig. 5A, 6A to 6C, 9K and 9L are plan views of an endoscope and/or endoscope-related device.

Detailed Description

The description is laid out as follows.

I. Overview

Partially reusable, partially disposable/replaceable endoscope, and coupling joint therebetween

Extendable, bendable or articulating camera tip

Additional features of endoscope

V. endoscope tip

Moulding of the various parts of the endoscope tip

V.B. fiber optic illumination for single use speculum tips

End design with light guide

V.D. diffusing terminal surface

VI antifouling and antifogging

VI.A. heating

For delivery packaging of endoscopes, a vial of fluid is used to protect the coating on the lens/window of the endoscope

Lens cover with optical correction for use during insertion of a partial endoscope

VIII.360 viewing angle end

IX. avoid the use of fasteners, springs and other small parts

Ix.a. push button without spring

Over-molding of an outer housing on a circuit board

IX.C. avoidance of internal fasteners

Rotational resistance by O-ring

Ultrasonic welding of two halves of an outer handle shell

IX. F. thermoplastic elastomer coated handles

X. liquid flow

X.A. liquid tight seal

X.B. induced helical flow

XI molding and joining

XI.A. chute for connecting different materials

XI.B. connecting the constituent parts of the obturator

Twist-lock the parts together

XII. Examples

I. Overview

Referring to fig. 1A, an endoscope 100 (e.g., arthroscope, laparoscope, etc.), a trocar 102, and an obturator 104 may be used in joint surgery, joint access, or other minimally invasive procedures. Minimally invasive surgery typically begins with the penetration of a surgical site with a pointed instrument, such as a trocar 102 or obturator 104. Trocar 102 is a hollow tube for piercing from the skin to the surgical site; the trocar 102 will remain in place during the procedure to maintain the access port. During puncturing, the trocar 102 may insert the obturator 104 through the lumen. The obturator 104 and/or trocar 102 may have a sharp point for penetrating into tissue of a joint, abdominal cavity, or other surgical site to form an access port. The obturator 104 may be inserted into the trocar 102 to act as a unit for piercing skin and other tissue, and once in the space of interest, the obturator 104 may be withdrawn, leaving behind a "trocar cannula". A speculum may be placed through the cannula to view the surgical site. The endoscope may be a "tip on a tip" endoscope having an illumination source and a camera 410. After cutting the access port through the obturator 104 and trocar 102, an endoscope may be inserted through the trocar 102 to the surgical site to provide visual access to the surgeon performing the procedure using other instruments. Other trocars may be placed for access by other instruments, such as laparoscopic scalpels, razors, staplers, and the like.

In some cases, the endoscope 100 may be inserted along the lumen of the obturator 104, and the tip of the obturator 104 may be transparent. The configuration of the endoscope within the obturator may provide visual guidance to guide the obturator 104 or trocar 102 to the correct surgical site. In other cases, the trocar 102 may have a sharp point and an endoscope may be inserted along the lumen of the trocar 102 to guide the trocar 102.

Referring to fig. 1B, endoscope 100 may have a number of features that ensure reliability, reduce manufacturing costs to the point where the entire endoscope or a portion thereof may be disposable. The re-sterilization of endoscopes is costly and is always imperfect, which increases the risk of cross-infection. Moreover, when the endoscope 100 is reused, the optics may be scratched and clouded, thereby reducing the accuracy of the view available to the surgeon. Sections II through XI will discuss a number of features of the endoscope that can provide such cost reduction and single use.

Referring to fig. 1C, the obturator 104 may be locked into the outer sheath or trocar 102 by twist locks 940, 942.

Referring to fig. 1D, the obturator 104 and trocar 102 may be used to penetrate a surgical site, such as the knee region behind the patella.

Referring to fig. 1E and 1F, the obturator 104 may be unlocked from the outer sheath/trocar 102. The obturator 104 and endoscope may be withdrawn, leaving the hollow trocar 102 as a port to the site.

Referring to fig. 1G, an instrument such as an endoscope 100 may be inserted through an outer sheath/trocar 102 to perform a procedure.

Referring to fig. 1H, the trocar/sheath 102 may be locked to the endoscope with the same twist lock motion as used to hold the outer sheath/trocar 102 on the obturator 104.

Various endoscope tip designs (FIGS. 2F-2M, 4A-4K, 4M-4W, 4X-4 OO) may have the following characteristics. The entire tip may be small enough to meet the size of the endoscope, typically the dimensions in the table of the following paragraphs. In some cases, the diameter of the tip may be slightly larger or smaller than the shaft. The tip may mechanically stably hold the camera 410, illumination device, fluid injection or discharge port, surgical tool, etc. within that diameter. The tip may be sealed against elevated pressures typically used to divert tissue out of the view of the speculum to prevent the intrusion of body tissue and fluids, as well as insufflation fluids. The tip may transmit or allow delivery of illumination light through LEDs mounted in the tip or using optical fibers 430 to transmit light from the handle or controller. The opaque portion of the tip assembly may exclude stray light from the illumination fiber/LED/light guide and reflected light from the surgical cavity. The tip can be manufactured in a desired number and cost. The tip may have a non-invasive configuration to surrounding tissue, e.g., without sharp points or edges. In some cases, the tip may have a puncture point for initial access. The tip may be designed to be anti-fog or anti-fouling. The tip may allow cleaning, preferably in situ at the surgical site.

Referring to fig. 2A, 2B, 2C, 2D, and 2E, the surgical endoscope 100 may be configured to allow the shaft 110 portion to be detached from the handles 112, 114 of the endoscope. A camera or image sensor 410 located at the distal end 116 of the shaft, any tele-camera mechanism, illumination, power and signal connectors, and fluid flow channels may be located in the disposable shaft 110. The handles 112, 114 may be designed to be reusable (which means that the handles 112, 114 may be sterilizable, such as in an autoclave or other sterilization apparatus, or may be protected by a disposable sterile sleeve). The joint 130 between the detachable shaft and the reusable components of the handles 112, 114 may be generally distal (but not necessarily distal-most) in the handles. The replaceable shaft portion 110 may be disposable, and the disposable portion 120 of the handle, which may be discarded with the shaft 110, may also be disposable.

Referring to fig. 2A and 2B, the handle of endoscope 100 may include three main components:

Disposable lid 120. This distal-most portion of the handle may serve as a mounting base for the shaft 110 and may be disconnected from the remainder 112, 114 of the handle. The disposable lid portion 120 (along with the shaft 110 and the inner element) may be disposable.

The rotating collar 112 may have surface structures 302, 304 to allow the surgeon to rotate the rotating collar 120 about the central axis of the handle (i.e., about the rotational axis 126 of the shaft 110). During surgery, the insertion shaft 110, disposable cap 120, and rotating collar 112 may be locked to rotate with one another such that rotation of the rotating collar brings about rotation 126 of the disposable cap 120 and shaft 110.

Proximal stationary handle 114 has a housing surrounding the elements within the handle. The outer diameter and outer surface of handgrip 114 may be designed to provide an easy and low slip grip for the surgeon's hand. The joint 128 between the proximal handle and the rotating collar may allow the two components to rotate relative to one another. In some cases, circuit boards and similar elements within proximal handle 114 may rotate within proximal handle 114 along with disposable lid 120 and rotating collar 112.

Disposable lid 120 and rotating collar 112 are separable from each other at joint 130 such that disposable lid 120 and shaft 110 may be disposable while handgrip 114 and rotating collar 112 (and elements therein) are reusable.

Referring to fig. 2A, 2B, 2C, 3A and 3B, three basic connections can be made between the disposable lid 120 and the rotating collar 112:

Rotational locking couplings 140, 142 for holding the disposable portion 120 on the reusable handles 112, 114. The couplings 140, 142 may have sufficient strength to transfer insertion and extraction forces, rotational, pitch and yaw torques, lateral forces, and the like from the proximal reusable handles 112, 114 to the distal disposable portion 120 and shaft 100, allowing the physician to align the illumination and/or camera as desired. The joint 130 between the disposable lid 120 and the rotating collar 112 may be generally toward the distal end of the handle. The disposable lid and rotating collar 112 may be engaged by a flat force transmitting surface 144 located at the center of the joint 130 and around the periphery so that these forces are supported around the periphery of the separable joint 130. The one or more release buttons 146 may be pressed or squeezed to disengage the one or more locking catches 148. The mechanical connection may include a rotatable locking ring or other release/securement mechanism.

Electrical connections for powering the illumination source and the camera 410 and transmitting optical signals from the camera 410 back to the processing board in the handle 112, 114 and to a display system external to the endoscope. The disconnectable electrical connection for power and signals may be implemented by USB-C connectors 150, 152, mini HDMI connectors, or similar connectors capable of maintaining the signal integrity of high speed signals. If illumination is delivered through optical fiber 430, connector 130 may include an optical connector.

Disconnectable connection to any panning mechanism for camera 410 may be achieved by a physical connector (e.g. a linkage mechanism).

In some cases, the camera/image sensor 410, LEDs, and electrical connections (as well as any mechanical connections for panning the camera/image sensor 410) may be detached from the insertion shaft 110. The shape of the shaft 110 and the cover 120 may be smooth and simple enough to facilitate sterilization. Similarly, once the electronics are removed from the interior of shaft 110, they may also be sterilizable. Particularly in the low labor cost market, it can be cost effective to disassemble, sterilize and reassemble the shaft and its internal components for reuse.

One or more fluid hoses 160 (or two hoses, one for fluid and one for gas) for priming liquid or filling gas may be accessed via the disposable cap 120 so that the entire set of fluid lines for priming/filling the channel may be discarded after use with the disposable shaft portion. In other cases (e.g., fig. 3E and 3F), the fluid hose 162 may enter the proximal end of the speculum, and the breakable fluid connection within the joint 130 for fluid inflow and outflow may be achieved by a gasket, O-ring, or the like. Either the connector for the hose may be located outside of the endoscope itself, either close to the endoscope (for applications where it may be desirable to allow for "quick change" of the insertion shaft 110 during a single operation), or remote from the endoscope, typically at a waste container, to facilitate disposal of all hoses that may be contaminated by contact with the patient.

The disposable shafts 110, 120 may be designed to facilitate disposal of components that come into contact with bodily fluids. Since sterilization is often imperfect, patient safety can be improved by discarding components that have been in contact with the patient's body fluids. In order to increase sterilization, it may be desirable to reduce the elements in the disposable components 110, 120 so that the cost of the disposable components may be reduced and the surface structures and crevices that may be difficult to sterilize. Thus, lens 460, image sensor, LED, tele-mechanism, and shaft 110 may be disposable. Further, since the shaft 110 is used for inflow and outflow of fluid and is disposable, sealing against body fluids may not be necessary.

Referring to the figures, referring to fig. 2D, the replaceable/disposable shaft 110 and its mounting element 120 may be specifically designed for use in different types of procedures. For example, a pure diagnostic scope 172 may have an outer diameter of 1 to 3 millimeters. The replaceable disposable cap/shaft units 110, 120, 178 for laparoscopic thoracic procedures may have shafts with a length of 400mm and a diameter of 10 mm. The length of the replaceable component 176 for arthroscopic surgery of the knee and hip may be 155 millimeters and the diameter may be 5.5 millimeters or 4 millimeters. For a facet joint, a replaceable shaft 174 having a diameter of 2.9 millimeters or less may be preferred. The replaceable shaft/speculum unit with the flexible end 200 may be sized for laparoscopic surgery. Typical dimensions for various surgical types may be as follows (in millimeters):

The various replaceable components 110 may have different instrumentation at the tip 116. For example, various replaceable shafts may have cameras 410 oriented at 0 ° (directly on the shaft axis), 30 °, 45 °, 70 °, and 90 °.

Referring to fig. 2B, the disposable shaft portions 110, 120 may be further separated into an outer sleeve 132 for protection and strength and an inner shaft portion 134 carrying various illumination, optical and fluid delivery elements. The speculum may be sold as a handle unit 112, 114 having a set of ten or twelve or twenty replaceable shaft/cover units 110, 120.

U.S. application Ser. No. 16/434,766, filed on 7, 6, 2019, and the formal drawings filed on 13, 8, 2019, are incorporated by reference.

Extendable, bendable or articulating camera tip

Referring to fig. 2F and 2G, the camera tip 202 is slidable within the cannula shaft 132 to be extendable and retractable. When extended, the distal portion of the camera handle 202 may be bendable, for example, as a rigid section 210 joined at an articulation joint. In fig. 2F and 2G, cone 204 shows the field of view of camera 410. The extendable/bendable portion of the shaft 202 may be formed from a series of elements, each of which is substantially rigid in the longitudinal dimension, but hinged at each joint to allow bending or flexing. As shown in fig. 2F and 2G, the hinges may all be in the same dimension. Alternatively, as shown in fig. 2H and 2I, hinge pivots 212 may be at alternating 90 ° angles, such that bending may occur in two dimensions, which in combination may result in a 360 ° bending angle. Or the bendable portion 202 may be formed of an elastic material, have an inner reinforcement that is relatively rigid and incompressible relative to a longitudinal compressive dimension, and are flexible in lateral and/or oblique bending. The bendable portion 202 may include two or four cable channels spaced around the outer surface such that tensioning the cable may cause bending in a desired direction.

Referring to fig. 2H, 2I, 2J, 2K, 2L, and 2M, in some cases, the camera 410 may be tele-able within the endoscope tip 400. For example, the camera 410 and its illumination LEDs may be mounted on one side of the base 220 formed as three rigid sections with two hinges 222, such that the two outer sections 224 may be moved 226 relative to each other and the central section rotated in place in a flexible parallelogram fashion. Two outer sections 224 may be mounted in the sliding channel and connected to a controller at the handle by a cable 228. Referring to fig. 2J, the substrate 220 may be molded onto a flat flexible backing. The backing may include folds 222 to form hinge points that allow the backing to fold into its parallelogram configuration (fig. 2K and 2L). The pivot point 230 may be molded into the base 220. Referring to fig. 2K, a flexible circuit 232 may be laminated to the substrate and control the tension cable 228 attached to both ends. A camera, illumination LED, pressure sensor, temperature sensor, or other sensor may be secured to the substrate 220. Referring to fig. 2L, the base 220 may be folded into three sides of a parallelogram, and the fourth side may be formed by a linkage connected to the hinge point. Further details are described in U.S. patent No. 9,375,139, incorporated herein by reference.

Longitudinal movement 226 of one face of the substrate relative to the other changes the angle of the central section and thus the angle of the image CCD or other camera and any other sensor. This may provide an adjustable viewing angle in a range of up to 90 °. The endoscope may also accommodate 180 ° or reverse views, where the endoscope has a flat top configuration and a rotatable or living hinge rectangular endoscope architecture.

Passages and holes for the ingress and egress of irrigation fluid, inflation fluid, or other fluids may be provided in the tip. The holes for flushing fluid may be intended to clear windows or lenses on the camera 410 of dirt.

At least one of the surfaces 224 may comprise a metal strip bonded to the section 224 or into the section 224. The metal strip may be spring steel or nitinol with a preformed radius of curvature. Or the metal alloy may be a ductile metal, such as aluminum, or may be a nickel titanium (nitinol) alloy with shape memory characteristics. The metal strips allow the elongate core to bend reliably in one plane of curvature. When the memory substrate is spring steel or nitinol, it may be bent into shape if malleable, or may be made steerable with nitinol shape memory components.

Referring to fig. 2N and 2O, lever 240 may be moved to advance/extend or retract/withdraw camera 410 within the insertion shaft (fig. 2F and 2G). Another switch/lever 242 (e.g., a paddle switch) may control the articulation of the camera tip to move in the positive and negative y directions by applying tension on the cable 228 extending to the tip to flex the articulating tip to cause rotational articulation of the extendable portion 202 along the shaft 110 at the joint 212. Another lever may be used to control camera panning (fig. 2H, 2I, 2J, 2K, 2L, and 2M).

Referring to fig. 2P and 2Q, a four-point controller 244 may control four control cables 228 or rods or other carrying members connected to the articulating or bendable portions of the extendable/retractable and/or articulating camera shaft 202 so that the camera ends may be articulated in the positive x, negative x, positive y, and negative y directions.

Referring again to fig. 2D and 2E, the extendable/retractable and/or articulating camera shaft 110, 200 may be used with a reusable handle, disposable tip configuration. The extendable/retractable and/or articulating camera shaft may be used with a reusable or disposable integrated speculum configuration.

Articulating camera end 200 may be particularly useful in abdominal, thoracic, and laparoscopic examinations. Typically, during abdominal surgery, the abdominal cavity is filled with carbon dioxide to provide the surgeon with a large open field of view. This provides a space for movement of the extendable/retractable and/or articulating tip. The extendable/retractable and/or articulating tip may be used to provide a view behind an organ (e.g., stomach or liver). If the surgeon has only a fixed field of view endoscope/laparoscope, the only way to obtain a field of view behind the organ is to open another port from the opposite side of the body.

Additional features of endoscope

Referring to fig. 2A and 2B, the disposable shaft portions 110, 120 may be further separated into an outer sleeve 132 for protection and strength and an inner shaft portion 134 carrying various illumination, optical and fluid delivery elements. Illumination may be provided by LEDs at or near the distal tip, or by illumination at an optical fiber or external controller from an illumination source in the handle.

Referring again to fig. 2A, the endoscope may have handles 112, 114, 120 and a shaft 110 for insertion into the body. There may be a camera, electronic image sensor, or other optical element at or near the distal tip 116 of the shaft 110. The orientation of the camera may be fixed in the scope, or may be tele-able. The camera 410 may be located at the tip 116, as seen from the outside of the shaft, or may be recessed a small distance behind the structural tip of the shaft. There may also be an illumination source, such as an LED, at or near the end. The tip 116 may have a rigid, pointed trocar tip, or may have a spoon-shaped portion that extends beyond the image sensor, or may be flexible (in the manner of a colonoscope tip), in each case extending a little beyond the imaging camera, to provide physical protection for the camera/image sensor 410 during insertion, or to protect the camera/image sensor 410 from the surgical cutting device.

The illumination may be visible light, infrared light and/or ultraviolet light. In some cases, an illumination LED (light emitting diode) or other illumination source may be disposed in the reusable handles 112, 114 or in the docking station/controller, and the disposable shaft may have an optical fiber 430 that transmits light to the tip, and the connector 130 may have an optical coupler. In other cases, an illumination LED may be disposed in the tip 116 to directly illuminate the surgical cavity; in this case, the connector 130 may have a power connector. In some cases, the LED may be recessed from the tip, or disposed somewhere in the shaft, or may be located in an external controller, and the optical fiber 430 may transmit illumination light to the tip. For example, the optical fiber 430 may be configured with a split such that the light is distributed in a desired pattern around the image sensor to better distribute the light into the surgical cavity around the image sensor.

The shaft 110 itself may be rigid, made of a non-bioactive metal (e.g., stainless steel or coated aluminum). In some cases, the surgical cavity around the endoscope tip 400 may be filled with a gas (typically carbon dioxide) or irrigated with saline. In either case, the inflow and outflow of fluid may be accomplished through a passage through the shaft.

The shaft 110 may also carry power lines to the illumination LEDs and the camera 410 with signal lines that carry light signals from the camera 410 back to the electronics in the reusable portion 112, 114 of the handle. Power to the camera 410 may be provided by conductors in a flexible cable or on a printed circuit board (flexible or rigid) and insulated with a shape-adapted insulating coating such as parylene. The same flexible circuit board 416 may have signal conductors for video signals from the camera 410. Video signals may be transferred from the camera 410 to the handle using any video signal protocol, such as MIPI (mobile industry processor interface) or HDMI. Parylene may also improve biocompatibility.

The shaft 110 may also carry a cable or other mechanical element to control panning of the camera 410.

Referring to fig. 3A, 3C and 3E, the rotating collar may have various features to facilitate rotation. For example, the recess 302 may provide a good grip for the finger to obtain a lighter turning torque. The tab 304 may provide greater leverage to achieve greater rotational torque and may also provide a fixed rotational reference point.

Button 310 may perform various functions such as turning on or off an illumination LED, taking a picture, starting and stopping a video, and so forth. Depending on the nature of the press, a single button may perform all of these functions. For example, the illumination LED may be turned on and off for 3 seconds. A quick press may take a single frame of still image. Double clicking can start and stop video recording.

If the camera 410 at the end 116 of the shaft 110 is tele-able or has other controllable features, a control device (e.g., a joystick or touch slide panel, etc.) may be present near the button 310 to control the adjustment of the camera 410.

One or more ultraviolet LEDs or other illumination sources may be disposed within handles 112, 114, within shaft 110, or near tip 116 to help ensure sterility of the device's internal components or water flowing through the device.

Referring to fig. 3C, 3E and 3F, irrigation flush/fill hoses 160, 162 may enter through the handle at various points. For example (fig. 3C), the irrigation/filling hoses 160, 162 may be accessed laterally via the tab 304, e.g., somewhere near the distal end of the handle. Alternatively, as shown in fig. 3E and 3F, irrigation/filling liquid/gas hoses 160, 162 may be accessed via the proximal end of handle 114. The hose may then be disconnected by fluid disconnect fitting 320 within fitting 130. In the event that the hose 160 for filling liquid/gas is accessed via the disposable lid 120 (fig. 3C), various fittings and strain relief structures 340 may be used to hold the hose 160 in place.

Referring to fig. 3B and 3F, the video camera 410 may be connected to a circuit board inside the handle 114 using electrical connectors 150, 152 such as USB-C or micro-HDMI connectors.

Referring to fig. 3B, the rotational locking couplings 140, 142 may rotationally lock the disposable lid 120 to the rotational collar 112. The various rigid and resilient structures 144, 148 may lock them together to withstand other forces and torques, and the release button 146 may allow them to separate to allow replacement of the disposable lid 120. The coupling between the cover portion 120 and the rotational locking couplings 140, 142 may place most of the stress at the perimeter of the joint so that the joint 130 may also carry and transfer forces (particularly torque).

Referring to fig. 2A, 3C and 3D, rotation between the fixed portion 114 of the handle and the rotating collar 112 may be provided by a rotating bearing at the joint 128.

Referring to fig. 3C, 3D and 3E, proximal handle 114 may comprise multiple components, typically components that are only accidentally contacted by the patient (and thus present less risk of cross-infection) are more costly (and thus desirable to be reusable), and may be sterilized or may be covered by a sterile sleeve. For example, proximal handle 114 may house a power transformer, signal amplifier, controller for illumination LEDs and cameras, mechanical control for panning camera 410, rotation sensor for correcting images from camera 410, and the like. The handle may also include connections to external sources and to target objects of electrical power, signals, fluids, and the like.

Proximal handle 114 may include a rotation sensor so that the angular orientation of camera 410 may be determined. For example, the inner surface of proximal handle 114 may mount one or more magnets 320, and printed circuit board 322 (which rotates with rotating collar 112 and disposable lid 120) may have hall effect sensors 324 that detect the magnets. This can be used to calculate the rotational orientation, which in turn can be used to "correct" the image from camera 410 on the video display screen.

The distal tip of the shaft, the camera 410 mounted therein, and the mounting of the components within the shaft 110 may be designed to be robust. Sometimes, during surgery, the tip of the endoscope may come into contact with a scalpel, an ablation probe, or a cautery probe, and it may be desirable for the tip to be robust to such contact. To reduce the risk that the element may shift and remain in the patient, the disposable shaft and its elements may be designed to avoid joints with a high risk of mechanical failure. The disposable optical system can prevent image degradation that occurs when non-disposable optical elements are reused during multiple procedures.

Endoscopes include, as one category, arthroscopes, laparoscopes, colonoscopes, and other specialized endoscopes for various body cavities. For arthroscopes used in joint surgery, the shaft may be as small as 4.5 millimeters, 5 millimeters, 5.5 millimeters, or 6 millimeters, and very rigid. For other endoscopes, such as colonoscopes, the diameter may be larger, while the shaft may be flexible.

The endoscope may be transported as a handle and a plurality of ends, each of which is individually sealed to ensure sterility.

Referring to fig. 3F, the hoses 160, 162 for irrigation/spray liquid/gas input, irrigation/spray liquid/gas output, and electrical connection wires 164 may be permanently affixed 340, 342 to the disposable lid 120. This arrangement may allow the hose 162, which carries water out of the surgical cavity and thus is contaminated, to be disposable and without fluid coming into contact with the reusable portion 114 of the handle. The hoses and wires 160, 162 may be routed through a channel 354 extending along the length of the reusable handles 112, 114. The channel 344 may have an inner diameter large enough to allow easy passage of the hoses and wires 160, 162, 164 and connectors 350, 352, and a continuous smooth wall that can be easily sterilized to allow for replacement of the replaceable components at any time. The channels 354 may be offset from the central axis to allow the printed circuit board 322 to be located on the central axis. The connectors 350, 352 at the ends of the hose and lines 160, 162 may be small enough to pass through the channel 354. Thus, replacement of the shaft 110, cap 120, hoses and wires 160, 162 may be accomplished by passing the connectors 350, 352 and hoses and wires 160, 162 through the channel 344. The electrical wire 164 may have a connector 354 at or near the junction 130, and the hose 160 for irrigation/spray liquid/gas flowing into the surgical cavity may likewise have a connector at the junction 130 to allow the hose to be reusable, or may be permanently secured 340 to reduce the likelihood of leakage. Having the hoses and cables 160, 162 generally on-axis reduces unwanted cable jitter and reduces unwanted torque on the cap 120 when the endoscope is in use. Forming the shaft 120, the cap 120 and the hoses 160, 162 as an integral unit for replacement reduces the likelihood of leakage and improves the sterility of the replacement operation.

Referring to fig. 3G, the reusable handles 112, 114 may be sterilized in a sterilizer 360. Preferably, the hoses 160, 162 and all other portions of the endoscope 100 that contact the patient or carry fluid that contacts the patient are disposable, and the design of the reusable portions 112, 114 reduces contamination by avoiding contact with the patient's body fluids. The sterilizer 360 may be arranged to receive one or more of the reusable handles 112, 114 and irradiate them with ultraviolet light from the ultraviolet LED 362. The rod 364 passing through the handle channel 344 may have individual ultraviolet LEDs 366 arrayed along its length to sterilize the interior channel 344.

V. endoscope tip

The components of the endoscope tip 400 may be designed to allow mounting of the camera or vision sensor 410, the illumination emission source, and the objective lens or window in a limited space, such as an endoscope or arthroscope for joint surgery, having a diameter of 6 millimeters or less, 5.5 millimeters or less, 5 millimeters or less, 4.5 millimeters or less, or 4 millimeters or less. In some cases, fluid management may be performed within the same space. In some cases, the shaft may have the strength and rigidity that are common in arthroscopes. In some cases, the illumination emission may be by one or more LEDs located at or near the distal end of the endoscope. In other cases, illumination emission may be through optical fiber 430 and/or light guide 450, with optical fiber 430 and/or light guide 450 conducting illumination light around camera or vision sensor 410 within the diameter of shaft 110.

Moulding of the various parts of the endoscope tip

Referring to fig. 4A and 4B, an endoscope tip 400 may be formed from a top mount 412, a bottom mount 414, and a flexible circuit board 416. The camera 410 may be mounted on one side of the flexible circuit board 416 and the illumination LEDs may be mounted on the other side. Transparent window 420 may protect camera 410 from external environments, such as endoscopic tissue and body fluids and pressurized spray fluids. The entire assembly may be locked together by over-molding.

Referring to fig. 4B, to assemble the components, one end of the flexible circuit board 416 (the end on which the LEDs are mounted) may be inserted into a slot or channel in the top bracket portion 412, the top bracket portion 412 holding the LEDs in place. The plate 416 may then be folded around the bend in the top bracket 412 such that the camera 410 passes through its Kong Jiuwei in the top bracket 412. Folding and rotation brings the LED close to the sensor, which allows the assembly to fit within 5 mm diameter of the tip 400. The bottom bracket 414 may then be in place, thereby holding the top bracket 412, bottom bracket 414, circuit board 416, LEDs, and camera 410 in their aligned positions. The locking notch and clamp or ultrasonic weld may secure the assembly together for a period of time. The overmolding process may then lock all of these together.

Referring to fig. 4C, 4D, 4E, 4F, and 4G, a transparent window 420 may cover the camera 410 to protect it. The window 420 may be of two thicknesses, the area above the camera 410 being thicker, and thinner for the portion for mounting and for the area through which the LED emits light. The peripheral ridge of the endoscope tip 400 may extend slightly beyond the window 420. The top mount 412 may include walls surrounding the LEDs. These shapes, alone or in combination, may provide one or more of the following advantages. First, these shapes may reduce stray light from the LEDs that is reflected from the interior into the camera 410. Second, the thickness of the window 420 on the lens side may reduce vignetting artifacts when the edges of the field of view of the camera image are blocked or the lens 460 collects less light toward its edges. Also, the shape of the lens may be used to reduce distortion such as fish eye distortion. Third, the ridge may tend to move tissue away from the lens 460, thereby reducing blurring and improving the field of view.

The window 420 of fig. 4E and 4F may be placed on the surface of the circuit board 416 and the assembly of LEDs and camera 410, top mount 412, bottom mount 414, and window 420 (fig. 4B, 4C). The assembly with window 420 may then be locked together by overmolding of the overmold (fig. 4C, 4D, 4G). Such overmolding may provide waterproof properties to the entire end assembly. The overmolded assembly may then be mounted onto the distal end of the insertion shaft of the endoscope.

Referring to fig. 4H, 4I, 4J, and 4K, in other cases, in one alternative, a transparent window 422 may be overmolded onto the top bracket 412 prior to assembly of the circuit board 416, LEDs, camera 410, and bottom bracket 414. When window 422 is overmolded, a flat platen may be placed to protrude through the aperture of camera 410 to provide a mold surface, thereby providing an optically smooth rear surface of window 422. The mold may be flat (planar) or may have a desired curvature to form a convex or concave lens in the overmolded window 422. As shown in fig. 4K, the periphery of the top bracket 412 may be shaped to provide a secure lock that engages the overmolded window 422. The circuit board 416 with LEDs may then be inserted into the slots and folded around the top bracket 412, and then the bottom bracket 414 may be snapped into place and ultrasonically welded.

Referring again to fig. 4A, at the upper right and lower right corners thereof, and with reference to fig. 4B, at the upper right corner of the top bracket 412 and the lower right corner of the bottom bracket 414, energy directors molded into the top bracket 412 and the bottom bracket 414 may improve ultrasonic welding. Ultrasonic welding may improve adhesion and waterproofing between the top mount 412, bottom mount 414, and deflector components. The energy director may be molded as a triangular profile ridge on the inner surface of the top bracket-bottom bracket assembly. The inner diameter of the energy director may be slightly smaller than the outer diameter of the deflector such that ultrasonic welding causes the energy director to melt and form a seal.

In summary, these features may provide an endoscope tip 400 that is very small in diameter (e.g., 4 millimeters or less, 5 millimeters or less, 4.5 millimeters or less, or 4 millimeters or less), or a tip 400 that is slightly larger than the endoscope shaft, with all components mounted within the tip diameter. Mounting the LEDs and camera 410 on opposite sides of the flexible circuit board 416 may help to make the overall assembly easier to manufacture. The manufacturing may involve inserting the ends of the flexible circuit board 416 into the slots and wrapping the board 416 around the molded parts or wrapping the board 416 into the channels between the molded parts to place the various parts in their preferred operational orientations. Such positioning of the plate 416, including bending and wrapping, may create some additional slack in the positioning of the plate 416, which may create some stress relief and improve reliability. The components may be ultrasonically welded together. Overmolding may be used to structurally secure the components together and provide a watertight seal. The transparent windows 420, 422 may be overmolded onto the structural members, or the structural members may be overmolded onto the transparent windows.

V.B. fiber optic illumination for disposable speculum tips

Referring to fig. 4L and 4W, a disposable endoscope 100 or a disposable tip for a reusable handle may have a camera 410 on the tip. Disposable endoscope 100 may use optical fiber 430 to transmit illumination light. Plastic optical fiber 430 may provide an attractive combination of attributes for disposable or single use endoscopic applications, including cost, flexibility to bend around curves and movement during surgery, numerical aperture (the angular taper of the fiber radiation light, and the taper to receive it), low thermal radiation at the surgical site, and manufacturing flexibility. Fiber optic illumination may provide sufficient illumination for applications such as laparoscopy, where the objective surface may be up to 200 or 300 millimeters from the camera 410 while avoiding heat dissipation issues that may occur due to placement of LEDs at the ends. Fiber optic illumination can reduce the complexity of the tip chip circuitry in the limited space of the endoscope tip 400. Fiber optic illumination may allow multiple illumination sources of different wavelengths to be used coupled at the collection end of the optical fiber to vary the illumination at the endoscope tip 400.

Referring to fig. 4L, one or more illumination sources 432 may be located in a reusable endoscope handle or base station/IPU/master controller. The illumination source 432 may be one or more of a single color LED, a white light source, a three color white LED, infrared or ultraviolet light, and the like. Illumination source 432 may be an LED, a combination of LEDs, a flash, an incandescent, or other illuminator. The optical fiber 430 may be coupled to an illumination source 432 at the collector end by a butt-joint adjacent or other collection mechanism. In some cases where multiple illumination sources 432 are provided, they may be located on a rotating turret, sliding multiplexer, or other switch that butt-couples successive ones of the multiple illumination sources with the coupling end of the optical fiber 430. The light source device 432, which is the same size or slightly larger than the collector end of the optical fiber 430, provides the most efficient butt-adjacent coupling.

The plastic optical fiber 430 is available as a fluorinated polymer optical fiber under the trade name Raytela ^TM from Toray Industries, japan. The plastic optical fiber 430 may reduce costs relative to the glass optical fiber 430, which may be a particularly important consideration in single use or disposable endoscope designs. The plastic optical fiber 430 may be formed of two different plastic resins having two different refractive indexes, with a resin having a higher refractive index being used as the core and a resin having a lower refractive index being used as the cladding. The boundaries between the layers may provide total internal reflection to conduct light along the optical fiber 430. The diameter of the optical fiber 430 may be selected to optimize a variety of simultaneous characteristics. The amount of light that each fiber can carry is approximately proportional to the cross-sectional area. The cost of an optical fiber is mainly proportional to the length, and the larger the diameter is, the smaller the cost increase amplitude is. Also, manufacturing costs generally increase as the number of fibers increases and as the number of broken or damaged fibers increases during the manufacturing process, so the fewer larger diameter fibers, the lower the cost tends to be. On the other hand, installing the camera 410 and any working channel devices is generally more difficult and easier to install into small spaces if the fiber diameter is smaller, which tends to favor a greater number of smaller diameter fibers 430. To optimize between these tradeoffs, in some cases at least nine optical fibers, at least twelve optical fibers, or at least 15 optical fibers may be used. The diameter of the fibers may be about 0.4 millimeters, 0.5 millimeters, 0.6 millimeters, 0.75 millimeters, or about 1 millimeter. They may be placed around the perimeter of the working end 400 of the speculum 100.

Referring to fig. 4L and 4W, in some cases, the optical fibers 430 may be relatively evenly spaced around the 360 ° circumference of the tip 400. The greater uniformity of placement of illumination fibers 430 and centering on camera lens 460 may reduce illumination variations, shadows, and other undesirable artifacts in the imaging field. In other cases, the distal face of the optical fiber 430 or the light guide 450 may be distributed over an arc of less than 360 ° (e.g., at least about 180 °, at least about 240 °, at least about 250 °, at least about 260 °, at least about 270 °, or at least about 300 °). In some cases, the endoscope may be used in close proximity to the anatomy in which the procedure is performed, so distributing the illumination emissions around the perimeter may reduce glare and hot spots. In some cases, larger fibers 430 may be used for a portion of the perimeter, while smaller fibers 430 may be used for portions of the endoscope end that are crowded with other mechanical components. The closer the fibers 430 are to a uniform 360 distribution, the more uniform the illumination and therefore the better the image. The use of fibers 430 with larger numerical apertures or other scattering (dispersion) at the ends can also improve scattering and thus improve illumination uniformity and image quality. The non-circular optical fiber 430 may be used to allow the illumination end of the fiber to have a larger surface area, thereby providing better illumination.

Referring to fig. 4M and 4N, the camera 410 may be mounted on a flexible circuit board 416. The lens 434 may be held in place by an inboard end portion 436, and these portions may be assembled into a lens subassembly 460.

Referring to fig. 4O, the two clamps 440 may have a cap form having an inner diameter that coincides with the outer diameter of the end mount 438 and having through holes that coincide with the locations of channels on the outer surface of the end mount 438 that provide the circumferential location of the optical fibers 430. The holes in the two clamps are typically opposed to each other in pairs. Referring to fig. 4P and 4Q, the optical fibers 430 may be routed through holes in the clamp member from one mating hole to another. Referring to fig. 4R, 4S and 4T, the tip base 438 may have a groove along its perimeter to capture the fiber 430, and a set of internal channels and features to hold the camera/inner tip portion assembly. Referring to fig. 4S and 4T, the end mount 438 may be seated into a fiber nest held in place by a clamp 440. Referring to fig. 4R and 4T, the camera/lens/inner tip portion assembly may be placed into the tip base 438 and the flexible sheet 416 may be placed in the channel formed by the optical fibers. The rear clamp 440 may then slip off the ends of the flexible sheet 416 and the optical fibers 430.

Referring to fig. 4U and 4V, the fibers 430 may be cut to match the surface of the end mount 438. The ends of the fibers may be polished, or the ends may be treated to diffuse light, as discussed below in section V.D. The end of the fiber may be covered with a window 420, typically glass or sapphire. The outer/distal surface of window 420 may be coated to receive a coating, such as described in U.S. patent application Ser. No. 16/069,220 and U.S. provisional application Ser. No. 63/193,387, which are incorporated by reference. Window 420 may have a coating to reduce illumination artifacts, such as reflection. The windows 420, 422 may be held in place by an adhesive. The adhesive may fill any air gap between the end of the optical fiber 430 and the window 420. Eliminating the air gap may improve light transmission from the fiber 430 through the window 420. In some cases, a lens or window 420 may be overmolded over the assembly shown in fig. 4T and 4U. Referring to fig. 4T, 4U and 4V, the assembly of fiber 430, tip base 438, inner tip portion 436, camera 410 and flexible plate 416, and window 420 may be passed through a stainless steel tube of the endoscope insertion shaft and slid into place for friction fit, or held in place by an adhesive, such as epoxy or an optical grade uv curable adhesive (available from Norland Products, of Cranbury, new jersey, HENKEL ADHESIVES division of Loctite, dymax of Torrington, ct.) or by a detent or deformation of the tube. The adhesive may also be used to seal the tip from fluid ingress. Referring to fig. 4W, the surface of the camera 410 may be recessed into a stainless steel tube. The surface of the window 420 may be flush with the end of the tube or may be slightly recessed to provide protection against window scraping or shifting. The recess may be covered by a transparent lens, which may be completely flat, or have features or lenses similar to those shown in fig. 4E and 4F.

V.C. end designs with light guides

The optical fiber 430 may be extruded into a shape that improves light transmission, such as a rectangular, or U-shaped light guide 450 that extends the length of the endoscope from the illumination source to a U-shaped exit surface at the distal end of the endoscope. In some cases, at least a portion of the length of each optical fiber 430 may be replaced by a shaped light guide 450, such as a circular or U-shaped ring of transparent light guides around the perimeter of the end mounts 438, 480. The light guide 450 may be a two-part structure with two different refractive indices for internal reflection similar to an optical fiber. In other cases, the light guide 450 may be formed of a transparent light transmission medium coated with a reflective coating (e.g., aluminum, gold, or silver). In some cases, the shaped light guide 450 may extend only a short distance, such as the length of the inner end portion, and conventional circular fibers may be used to bring light from the illumination source to the proximal end of the light guide 450 at the end mounts 438, 480.

Referring to fig. 4X to 4EE and 4MM, a light guide 450 may be placed along the perimeter of each component of the tip to conduct light from the optical fiber 430 to the tip around the molded component and image capturing component of the distal tip of the endoscope. The light guide 450 may be made of transparent optical plastic or glass. The outer diameter of the shaft 110 may be designed to be small to reduce trauma and tissue damage, while the camera 410 and other components may be as small as the technology allows. Accordingly, it may be desirable to reduce the diameter of light transmission from the rear of the tip structure to the surface of the tip while maintaining a sufficiently large cross-sectional area to transmit sufficient light. It may be desirable to arrange the illumination exit around a substantial portion of the circumference of the distal end of the speculum to provide uniform illumination. Referring to fig. 4X, 4Y, 4Z, 4AA, 4BB, and 4CC, three or four light guides 450 having arcuate cross sections may be arranged around the circumference of the tip. Each light guide may receive one or more optical fibers 430 that transmit light from LEDs in the handle or control box.

Fig. 4Y shows a cross-section of the light guide 450, illustrating narrowing from a larger diameter fiber 430 (possibly 1 millimeter) to a thickness of about 1/2 millimeter or less at the point of connection with the fiber 430 to squeeze the flow of light between the central base members 438, 480 and the outer metal shaft 110. The angle of the narrowed section 452 can be less than the internal reflection angle of the material of the light guide 450. In the narrowed region 452, the surface may be highly polished to achieve high internal reflection. The axis of the fiber 430 may enter at the center of the thickness of the light guide 450. With this arrangement, the cross-section of the 1 millimeter diameter fiber 430 and the cross-section of the light guide 450 may be approximately equal, with the narrowed region 452 designed to capture all light from the fiber 430 and direct it into the light guide 450 through a channel between the camera mount 438, 480 and the wall of the shaft 110 narrowed to about 0.5 millimeters.

Referring to fig. 4Z, the surface of the light guide 450 may be concave grooves or scallops (scalloped) 454. The entrance 456 into the recess region at the proximal end of the recess 454 may taper at an angle less than the total internal reflection angle of the material. Groove 454 may provide two advantages.

First, the grooves 454 may encourage light to organize into flows along the light guide 450 as it exits the narrowed region 452 of the light guide 450. Light pipes in this region to guide light through the narrow portion of the camera at the distal end of the endoscope can balance two somewhat contradictory conditions: it is desirable that the optical flow through the light guide 450 be maximized, while the illumination light should be dispersed throughout the field of view of the camera 410. The dispersion of the fibers is limited solely by the numerical aperture (scattering or collection angle at both ends of the fibers), i.e., the internal reflection angle, which in turn is determined by the refractive index difference between the fiber core, cladding and the surrounding material (typically air) surrounding the fibers. Scattering greater than the fiber numerical aperture may allow illumination light to reduce darkness at the edges of the lens field of view (about 70 °) of the camera 410. The grooves/scallops 454 may produce a suitable level of scattering within the light guide 450 such that when light exits the light guide 450, the scattering at the distal end of the speculum may nearly match the field of view of the lens 460.

Second, the light guide 450 is organized such that contact between the inner surface of the shaft 110 and the outer surface of the plastic light guide and between the inner surface of the light guide 450 and the outer surfaces of the pedestals 438, 480 occurs in a line contact manner, which may reduce light leakage. The walls of the fiber 430 have two internally reflective interfaces, one between the core and cladding of the fiber 430 and one between the fiber 430 and the outside air. The shape of the light guide 450 may be designed to increase air containment and reduce contact with epoxy or other materials in order to reduce light leakage.

The light guide 450 may allow for easier and higher throughput guiding of illumination light over 30 °, 45 °, 60 °, or 70 ° offset ranges, which may reduce brightness, power consumption, and heat generation at the illumination LEDs.

Referring to fig. 4AA, 4BB, and 4CC, the light guide 450 may be formed to receive the fibers 430. The coupler may be arranged to capture as much light as possible from the fiber 430 and transmit the light from the fiber 430 to the light guide 450, and may be arranged to structurally retain the fiber 430 for ease of assembly.

Referring to fig. 4DD, the light guide 450 may be formed by deforming the fibers 430 themselves. This may enable a higher throughput coupling from fiber 430 to light guide 450 than the butt coupling of fig. 4AA, 4BB, and 4 CC. The optical fiber may be deformed by gentle heating (e.g., in steam) followed by application of pressure. Pressure can be applied in a highly polished mold to provide a highly smooth surface. The shaped fiber ends may provide greater tolerance for small misalignments during manufacture than the high precision placement required for butt coupling.

Referring to fig. 4EE, three light guides 450 may be molded together as a single component. This may facilitate assembly in two ways. First, the technique may allow the assembly process to manage one larger component rather than assembling three small components. Second, the three prongs of light guide 450 may hold the entire assembly of front mount 482, rear mount 484, lens assembly 460, camera sensor 410, and flexible board 416 (fig. 4JJ, 4KK, and 4 LL) together as a unit for further assembly.

Referring to fig. 4FF, 4GG, and 4HH, lens assembly 460 may be formed in a tube 462, with tube 462 surrounding an end cap 464, a first lens 466, a spacer/iris 468, and a second lens 470. The diameter of the circular members 464, 466, 468, 470 may be about 1 millimeter or 1.2 millimeters. To facilitate reliable assembly, the shape 474 embodies error proofing principles such that they can only be stacked in one way. For example, taper angles, lines and curvatures, etc. 474 may vary at different junctions such that the components cannot be assembled in the wrong order. For both lens components 466, 470, the lens itself is simply a central circular portion 472 (which looks similar to the cornea of an eye in fig. 4 FF). The optical lenses are shown in fig. 4HH as depressions 472 in the front lens and raised bubbles 472 in the rear lens. The center spacer 468 may have a precise lateral depth to ensure the correct spacing between the two lenses 466, 470, and a relatively small center aperture to block excess light. The outer cover 464 may serve as a positioning spacer, as a flange to capture other components and/or to block excess light. The excess light that is blocked may be light that leaks from the light guide 450 or may be light that is indirectly reflected from within the surgical cavity but outside the image area. The excess light may be blocked so that it does not degrade the image quality.

Referring to fig. 4II, the camera sensor chip 410 may be mounted on a flexible circuit board 416. Referring to fig. 4JJ, 4KK, front mount 482 and rear mount 484 may be used to form the ends, front mount 482 and rear mount 484 in turn holding camera 410 and cover window/lens in place. Front base member 482 and rear base member 484 may be molded as individual members made of opaque plastic. The sides of front mount 482 and rear mount 484 may have channels 481 that hold light guide 450 to the perimeter of mount 480. Front mount 482 and rear mount 484 may have features 489 at joints that mate in only one manner (e.g., rounded protrusions on front mount 482 that mate with rounded recesses in the rear mount, and square mating features for ensuring angular reproducibility). Front mount 482 may have stepped conical bore 486 to reduce stray light interference reaching the camera. Rear mount 484 may have an opening such that it does not contact light guide 450 in the narrowed region because the internal reflection angle of the fiber optic component is higher when backing air than when backing plastic. A lens assembly (460 in fig. 4GG, 4HH, 4JJ, and 4 KK) may be mounted in front mount 482. Rear mount 484 may then be slid over the length of circuit board 416 such that circuit board 416 extends through the central aperture of rear mount member 484. Camera sensor 410/circuit board 416 may then be mounted to front mount 482. Rear mount 484 may then mate with front mount 482, which holds lens assembly 460, camera sensor 410, and plate 416 in place relative to both mount components 482, 484. This approach may reduce the bending of the board 416, which may reduce the risk of stressing the flexible board 416 and its electronics, but still create some slack and stress relief in the assembly.

The bases 480, 482, 484 may in turn mount transparent windows. The window 420 may be molded and glued in place or may be over molded last as a molding process that holds the other components together. Light may be transmitted from the optical fiber through the light guide 450 to the surface of the speculum.

At this point, the placement of the lens 460 may be calibrated. In some cases, lens tube 462 may be made of ferromagnetic or paramagnetic material such that a magnet may be used to move lens assembly 460 within front mount 482 to focus the lens on image sensor 410, thereby improving focus, focal range, and field of view. As shown in fig. 4JJ and 4KK, a small amount of adhesive may be applied through the microneedles through the wee holes 488 to secure the lens assembly in place. This also seals the weep hole 488 from fluid intrusion. The light guide 450 of fig. 4X-4 EE may then be added to the channel 481 at the side of the base 480, and the window 420 may be added to the front of the base 480. This assembly is shown in figure 4 MM.

Referring to fig. 4LL, the window part may have a step engaged with the edge of the shaft tube 110. The step labyrinth may provide a seal to prevent intrusion of fluids and pressurized atmospheres, which is common for surgical insufflation. In some cases, the window may be secured and sealed with an adhesive.

Front and rear mounts 480, 482, 484 then retain lens assembly 460, camera image sensor 410, and flexible plate 416 in proper spatial relationship within shaft 110. This reduces the number of parts. Base 480 may retain all of the components in an assembly that may be installed in shaft 110 in a single operation, thereby simplifying manufacture. The components 474, 489 may use error-proofing design techniques such that the configuration of the components allows assembly in only one way and draws attention to errors before they propagate.

V.D. diffusing terminal surface

In some cases, the distal surface 490 of the fiber 430 or light guide 450 may be roughened or coated with a diffuse coating, similar to the coatings used to coat the interior of soft white light bulbs. By diffusing light at the exit end 490 of the fiber 430 or light guide 450, the scatter angle can be increased, which increases the illumination cone and field width, and can reduce unwanted shadows and other artifacts. In some cases, scattering may be achieved by a holographic diffuser in the fiber 430 or light guide 450. In other cases, the diffuser may be applied by a random treatment such as sandblasting, molding against a sandblasted surface, or by some similar random treatment. In other cases, one or more texture patterns may be photo-etched in the steel of the mold for the fiber or end of the light guide 450. An exemplary texture may be a series of micro-domes, each small circular feature having a lens profile designed to diffuse light. The micro-domes may be randomly arranged and have random dimensions to avoid collimation or diffraction in a particular direction, which may lead to cold spots. In some cases, the distal surface 490 may be roughened by a rough grinding process, similar to the early stages of grinding the lens. An opal glass may be embedded into the distal end 490 of the light guide 450. The distal end 490 may be textured to have other diffusing patterns such as circular, linear, or hexagonal.

VI antifouling and antifogging

VI.A. heating

Lenses may also be fogged by condensation of water vapor from the body cavity in which the procedure is being performed. Endoscope tip 400 may be the coldest spot in the body cavity because it is non-living tissue that has no metabolism, and because the operating room typically remains fairly cool and the stainless steel insertion shaft conducts the cool from ambient room air to the tip. In some cases, the distal end of the endoscope may be heated. In some cases, the illumination LEDs may provide slight heating, which may reduce condensation and fogging on the ends. Heating only a few degrees is sufficient to ensure that the endoscope is not the coldest spot within the lumen. In some cases, the holes for injection of fluid (brine, carbon dioxide or other, as the case may be) may be oriented to direct the fluid across the window surface to provide additional cleaning.

Referring to fig. 5A-5C, the obturator 104 and/or the optical lens/window of the endoscope may be coated with an anti-stick coating. The shipping or delivery package for the endoscope 100 and/or obturator 104 may include a hole, vial or other containing structure 510 to hold the anti-stick lubricant in contact with the coating on the objective lens or window 420 of the endoscope between manufacture or refurbishment until use, thereby improving the coating. The aperture/vial 510 may have a cap that holds the lubricant in contact with the lens/window substrate surface to retain the coating. The cap may have a seal against the external environment and a seal that seals around the shaft of the endoscope. The lubricant may be held in place over the endoscope lens/window by a rigid cover or a flexible condom.

The lens/window 430 of the endoscope 100 may have a coating to enhance the optical or mechanical properties of the endoscope, and the packaging of the endoscope may incorporate a vial or aperture or cap 510 containing a lubricant to keep the lubricant infused into the holding matrix. The coating may be an anti-adhesion coating to reduce the build up of contaminants on the lens/window surface, thereby maintaining a clear forward view of the endoscope. The anti-stick coating may be applied in two steps, first building up a porous matrix or network to retain the lubricant on the lens/window surface, and then applying the lubricant. The lubricant may be an oil or other liquid or gel such that the lubricant acts as a liquid-liquid surface. The injected liquid may be silicone oil (Momentive or Gelest polydimethyl siloxanes, such as 10cSt, 350cSt, 500 cSt), perfluorinated fluids (perfluorinated perhydro phenanthrenes or Vitreon, and 80cSt to 550cSt perfluoropolyethers or (PFPE): duPont Krytox series), or other liquids or gels, having a suitable combination of high transparency, low surface energy, suitable viscosity and volatility so it will remain chemically inert on the surface and be previously approved by the U.S. Food and Drug Administration (FDA). Suitable Anti-adhesion coatings are described in Thin Layer Perfluorocarbon (TLP) coatings developed by the Kadson university Hansjorg Wyss Bioheuristic engineering institute, reference https:// wys. Harvard. Edu/technology/TLP-a-non-stick-coating-for-media-de vices (incorporated by reference), and U.S. patent application Ser. No. 16/069,220, "Anti-Fouling Endoscopes and Uses Thereof (Anti-fouling endoscope and its use), filed 24.10 months in 2018 (incorporated by reference), and commercially developed by Adaptive Surface Technologies of Cambridge, massachusetts as Smooth Liquid Infused Porous Surface (SLIPS) coatings, as well as other waterproof coatings and additives, reference https:// adaptive surface. Tech and its subpages (incorporated by reference), and Steffi Sunny et al TRANSPARENT ANTIFOULING MATERIAL FOR IMPROVED OPERATIVE FIELD VISIBILITY IN ENDOSCOPY (transparent material for improving the visibility of endoscopic surgery), anti-fouling materials, proceedings of the National Academy of Sciences,2016 for 18 months; 113 (42): 11676-11681.Doi:10.1073/pnas.l605272113 (2016, 9, 29) (incorporated by reference).

The aperture or vial may be shaped such that the cap includes a suitable seal 512 to retain the protective oil or gel. For example, the rim around the cover may have a labyrinth seal. The two parts of the end wall may each enclose the endoscope shaft slightly more than 180 degrees in order to form a seal. The two parts of the end channel may have labyrinth seals against each other. The nature of the seal 512 may vary depending on the viscosity of the lubricant and the surface energy of the lubricant relative to the material of the cap.

Any excess lubricant may be wiped off when using endoscope 100. If the lubricant is biologically inert and non-toxic, it can be left in place to protect the lens during some penetration stage.

Referring again to fig. 5A, in addition to the holes or vials or other holding devices for the anti-stick lubricant, the shipping, delivery or storage box for the endoscope may also have compartments for one or more endoscope insertion shafts, for handles, for various hoses and cables, and occluders 104.

Referring to fig. 5D through 5J, an end cap 520 may be secured to an end of the endoscope to change the angle of view so that a single endoscope may be used for two different stages of surgery. During penetration using an endoscope with a 30 ° viewing angle offset, the endoscope may be equipped with a refractive cover or prism that bends the light rays to reduce the offset angle. The refraction of Qu Guanggai 520,520 may produce a 0 deg. on-axis line of sight, or an angle near zero, such as 3 deg., 5 deg., or 10 deg.. A speculum having Qu Guanggai 520,520 may be used during initial penetration of the trocar 102 and obturator 104 to give a straight forward line of sight or near straight forward line of sight within 3 °,5 °, or 10 °. Referring to fig. 5E and 5H, once the trocar 102 and obturator 104 have reached the surgical site, qu Guanggai 520 can be removed from the endoscope 100 to create a 30 ° offset endoscope. Removal may require withdrawal of endoscope 100 and then reinsertion. Then, referring to fig. 5F, the endoscope 100 may be returned along the trocar 102 for use in a surgical procedure with a 30 ° offset field of view. Typically, the obturator 104 is discarded once the puncture is complete.

Qu Guanggai 520,520 can be molded from a transparent plastic such as polycarbonate, acrylic, styrene, polyolefin, silicone, or an inorganic transparent material such as silica (silicon dioxide). In some cases Qu Guanggai may be formed of a variety of materials, such as glass and plastic, or two different plastic resins, to combine light refraction and various mechanical functions, such as providing a sharp piercing tip for use with an endoscope without an obturator. Referring to fig. 51 and 5J, qu Guanggai 520,520 may be formed from different materials that provide different properties. For example, high index prism 524 may be embedded in a lower index plastic such that the plastic may be shaped in a desired manner. Qu Guanggai 520 can be shaped to provide a non-invasive rounded nose 526 to avoid tissue damage. In other cases, as shown in fig. 5D-5F, 5J, the low index plastic may be shaped with a piercing tip 528. The tip may be reinforced by a steel piercing tip.

One or the other surface may be convex or concave 530 to widen or narrow the field of view, or to enlarge or reduce the line of sight of the front view. Qu Guanggai 520 can allow for the use of a single endoscope in two different phases of a procedure, where two different lines of sight are required. Diopters may be sufficient to reduce the offset angle by 5 °, 10 °, 15 °, 20 °,25 °, or 30 °. In some cases, obtaining a partial correction on the axis of less than 0 ° may be sufficient to improve the line of sight during lancing. In some cases, the apex of the obturator 104 may create optical distortion, and thus it may be desirable to maintain a certain optical offset to keep the distortion away from the center of line of sight.

Qu Guanggai 520 may be attached to the end of endoscope 100 by a friction fit or interference fit (Qu Guanggai having an inner diameter equal to or slightly less than the outer diameter of endoscope end 400), by a weak or frangible adhesive, by small bumps on the inner diameter of Qu Guanggai that engage recesses or dimples in the end of endoscope 100, threads or channels on the inner diameter of Qu Guanggai 520 that engage small raised studs on endoscope 100, or by other connectors. The sleeve portion Qu Guanggai 520,520 may be formed of a heat shrink plastic or other material that may shrink to secure the connection. Qu Guanggai 520,520 may be held in place by a resilient plastic sleeve (e.g., a condom). Although it is not desirable that Qu Guanggai for 520 to fall off during use, this is a less serious event, as the endoscope with the refractive cover 520 is located inside the obturator 104 and Qu Guanggai will be captured and removed when the obturator 104 is withdrawn.

Qu Guanggai 520 may have holes through the attachment sleeve to allow fluid flow and/or suction to flow through the passageway in the endoscope shaft.

Qu Guanggai may be etched with a reticle or measurement scale on the surface of Qu Guanggai. The gauge may be marked with a scale that the surgeon can use to measure the size of the object that is seen through the endoscope. The surgeon may also use the reticle to align the endoscope within the surgical field.

Qu Guanggai 520 may have filters, for example, to reduce light reflected into the endoscope, blocking light of certain wavelengths. The filter may include a polarizing filter, a bandpass filter, a color filter, or an interference filter. These filters may be used in combination with dedicated light sources (e.g., ultraviolet, infrared, or polarized) and video processing for therapeutic and diagnostic purposes. Thus Qu Guanggai 520,520 may be part of an integrated system that uses different wavelengths of light and/or different colors of light and filters the light to diagnose pathology. Further, qu Guanggai may also be provided as part of a system to deliver photonic energy to a surgical site to control and visualize photodynamic therapy.

Referring again to fig. 5G, in some cases, the objective/window of the endoscope may be treated with a coating (e.g., an anti-stick coating), and the endoscope may be delivered with an anti-stick lubricant in the space between the lens/window and the proximal surface of the Qu Guanggai prism. In this case, the endoscope may be used as shown in fig. 5D, 5E, and 5F, with Qu Guanggai a 520 first attached to provide a line of sight offset approaching 0 °. Qu Guanggai 520 can then be removed 520, leaving the endoscope with a 30 ° offset, with the anti-adhesive coated lens/window exposed into the surgical cavity.

VIII.360 viewing angle end

Referring to fig. 6A, 6B, 6C, 6D, and 6E, endoscope tip 640 may provide a 360 ° view. The two cameras 410 may be mounted opposite each other with a hemispherical lens 642 above them. Hemispherical lens 642 may be optically concave (as shown in fig. 6D) to widen field of view 644. The exit end 644 of the LED or fiber 430 may be arranged around the tip 640 to provide 360 ° illumination. Electronic image processing may be used to combine the two hemispherical views into a complete 360 view.

IX. avoid the use of fasteners, springs and other small parts

The moving and structural components of endoscope 100 may be connected and secured in place using techniques that avoid the use of small components such as fasteners and springs. These manufacturing techniques may reduce molding costs, reduce assembly costs, reduce manufacturing processes, and reduce the likelihood that individual components (e.g., steel springs or screws) may loosen and compromise patient safety. Also, assembly can be accomplished without potentially toxic adhesives or solvents.

Ix.a. push button without spring

Referring to fig. 7A, a control button 710 for an endoscope may be formed as a single piece, with the button, its guide rail, and its spring 712 molded as a single piece.

The single component can be manufactured to simultaneously provide sufficient rigidity so that button presses are transferred from the top to the bottom of the button, and yet sufficient resilience in the beam structure 712 to provide a restoring force that returns the button to its non-pressed state. The ring beam structure 712 may be molded with flexible protrusions extending from the unitarily molded component. These extended flexible protrusions 712 may act in a combination of bending and twisting such that when button 710 is released, the elastic memory of the material will spring the button back to its original position. Fig. 7B and 7C show the button in its normally up position with the spring ring 712 in its initially molded planar configuration. Fig. 7D and 7E show the button being depressed and the spring ring 712 torsionally deformed.

The spring-loaded button may be molded from ABS plastic.

In some cases, the handles may have metal fasteners and other small metal parts, or may be assembled using chemical adhesives or the like, but they may be fully or partially encapsulated in a sufficient over-molding to ensure that they do not loosen, escape or come into contact with liquid flowing into the patient.

Over-molding of an outer housing on a circuit board

Referring to fig. 7F and 7G, the circuit board 722 to be mounted within the handle and its connection cables to be fed forward into the insertion shaft and its connection cables to be fed backward into the supporting power supply and computer drive may be overmolded 720 using low pressure overmolding. The overmold 720 may include through holes that provide secure mechanical mounting points for mounting within the handle. The overmold 720 may provide a cover that protects all sides and has resiliency to protect the circuit board 722 from mechanical damage during manufacture and use. The overmolded housing 720 may provide strain relief for the cable 724 at both ends of the circuit board 722 to reduce damage that may result from pulling the cable 724. The overmolded housing 720 may provide a uniform seamless covering to protect the circuit board 722 from water intrusion. The overmold 720 may prevent fluid ingress to a level of IP65 under international standard EN 60529. The liquid-tight protection of the overmolded housing 720 over the circuit board 722 (and any other liquid-sensitive components within the handle) may allow for sterilization of the interior of the handle by flowing a sterilization liquid or gas through the interior of the handle, and may provide dielectric protection from electrical shock to the patient. These advantages may be achieved by reducing manufacturing to a single manufacturing process.

IX.C. avoidance of internal fasteners

Referring to fig. 7H, the overmolded circuit board structure may be mounted within the handle by molding clips, heat staking, and the like, thereby forming a unitary structure without the need for separate small part fasteners. In fig. 7H, the inner housing of the handle may be molded in two parts 732, 734. The upper half 732 shown flipped up and down in fig. 7I may be molded with a plurality of molded bosses 736. In fig. 7H, the button has been flipped up and down and secured in place; the annular resilient protrusion is visible. In fig. 7I, the overmolded PC board 720 may be placed on the boss 736 such that the boss 736 protrudes through the through hole in the board housing. In fig. 7J, thermal and/or ultrasonic vibration may be used to melt the ends of the boss 736 into a dome or head 738 that holds the button and PC board in place.

By these techniques, endoscope 100 can be assembled into a sturdy structure without requiring separate assembly steps or small parts that can be displaced, and without toxic adhesives or solvents.

Rotational resistance by O-ring

Referring to fig. 7K and 7L, the inner housing 742 and the outer handle housings 732, 734 are rotated relative to one another so that the surgeon can adjust the field of view using the magnetic hall effect sensor 324 discussed above. The inner handle 742 rotates in unison with the rotating collar 112. The inner handle 742 and the rotating collar rotate relative to the outer handle 114. The inner handle 742 and the outer handle shells 732, 734 may be coupled by two silicone O-rings 740 that provide some friction to maintain their relative positions while allowing the surgeon to rotate the two handle components to adjust the field of view of the arthroscope.

For assembly, the cylindrical inner handle may be fully assembled, and the O-ring 740 may be fitted into its two retaining channels on the end of the inner handle 742. The two halves, which may then be the outer handle shells 732, 734, are closed like a bun over a hot dog, enclosing the inner shell and O-ring 740. The two halves of the housing 732, 734 may then be ultrasonically welded to each other.

Ultrasonic welding of two halves of an outer handle shell

Referring to fig. 7M and 7N, the two halves 732, 734 of the housing may be ultrasonically welded without an adhesive or solvent. Referring to fig. 7O and 7P, the two housing halves may have locking clips or hooks that may snap together to temporarily secure them before ultrasonic welding begins.

Referring to fig. 7O, 7P, 7Q, 7R, 7S, 7T, 7U, 7V, 7W and 7X, various energy directors and slots may be designed to ensure high efficiency of ultrasonic welding. In each case, the height of the energy director is slightly greater than the depth of its mating slot and the width of the energy director is slightly narrower than the slot. Ultrasonic vibration may cause the energy director to melt slightly and deform to fill the slot. The ultrasonic weld joint may be very close to a cavity that completely encloses the outer handle to reduce the likelihood of any fluid from outside invading the interior of the endoscope. Any fluid carries a risk of pathogens. It is difficult to sterilize the interior of a device such as an endoscope, so that it is important to exclude fluids from any reusable components.

IX. F. thermoplastic elastomer coated handles

Referring to fig. 7Y and 7Z, a high friction surface 750 may be bonded or overmolded onto the outer surface of the outer handle shells 732, 734 to provide high friction contact between the surgeon's gloved hand and the handle. During surgery, the surgeon's glove and/or handle may be covered with body fluids and other liquids, reducing friction, making it difficult for the surgeon to maintain control of the solid state endoscope. By covering the endoscope handle with a high friction compound 750, such as a thermoplastic elastomer (TPE), the handle becomes more friction, which may improve surgeon control. If the cover is overmolded as a single unitary layer, it may provide additional sealing against fluid intrusion. A medical grade biocompatible TPE is MEDALIST MD-34940 or MD-34950 from Teknor Apex Inc. of Pawtucket, rodeisland.

X. liquid flow

X.A. liquid tight seal

Referring to fig. 8A and 8B, the joint between the handle body and the outer sheath or insertion trocar 102 can be designed to provide a watertight seal between the endoscope and the outer sheath/trocar 102 without the use of an O-ring. The O-ring at this joint may be undesirable if it may fall off during mid-procedure or be introduced into the patient when the endoscope is locked into the outer sheath/trocar 102. In fig. 8A and 8B, the seat cup for the outer sheath/trocar 102 is shown in cross-section such that the convexly tapered inner surface 810 of the seat can be seen, and the female mating taper 812 on the nose of the endoscope is shown in plan view such that the mating between the surface of the convexly taper and the inner surface of the female taper in the cup of the outer sheath/trocar 102 can be seen.

Fig. 8C shows two cones 810, 812, some of which are enlarged in size. The male taper 810 may have a slightly sharper (about 1/2) taper angle than the female taper 812. The maximum diameter of the concave cone 812 may be slightly smaller than the maximum diameter at the base of the convex cone 810 such that the two surfaces 810, 812 will form a watertight interference seal. When the diameter of the two cones is in the range of 19 to 25 mm, the interference of the diameters may be of the order of 1/2 mm. The angle may be about 15 deg. and the two cones may differ by about 1/2 deg.. Also, at the small end of the cone, the outer diameter of the male cone 810 may be the same as the inner diameter of the female cone 812, but the male cone 810 may have a small ridge 814 at its circumference, which also causes a watertight interference seal at that end. The polymer of the components may be selected to provide an appropriate amount of elasticity for the interference fit to properly seal the water.

Fig. 8D shows ridge 814 molded onto the small end of the male cone. The ridges on the male taper 810 may form an interference seal with the minor end inner diameter of the female taper 814 in the mounting cup of the outer sheath/trocar 102. Fig. 8E shows two mating components.

In other alternatives, an O-ring may be used as a seal between the endoscope and the outer sheath/trocar cap. The O-ring may be seated in a channel on the surface of the inner convex cone such that the concave cone engages to compress the O-ring into its channel before contact begins to translate into a lateral force that displaces the O-ring. An O-ring may be particularly desirable at the large diameter end of the convex cone abutting the endoscope base surface so that the concave surface of the outer sheath/trocar cap does not displace the O-ring. In some cases, the angle of the taper may be less than 15 ° such that the compressive force on the O-ring created by the twist lock (see discussion of fig. 9J, 9K and 9L in section xi.c) is increased relative to the longitudinal friction force that tends to displace the O-ring.

X.B. induced helical flow

Referring to fig. 8F, the chamber 820 between the fluid tube and the fluid flow ring of the outer sheath/trocar 102 may be designed as a squeeze cone to impart a helical flow to water or similar flushing fluid. When water flows through the narrowed conical passage, the spiral flow 822 may be induced by the bernoulli effect and the venturi effect. The helical blades on the two conical surfaces can further accelerate the helical flow.

This flow pattern may have several advantages. The spiral flow 822 may increase pressure and water velocity as water flows out of the inducer aperture at the distal end of the endoscope. The spiral movement 822 may help clean any debris that has accumulated on the front window in front of the camera 410.

XI molding and joining

XI.A. chute for connecting different materials

Referring to fig. 9A, 9B, 9C, and 9D, a member made of stainless steel may be connected to a member made of plastic such as ABS without using an adhesive. One such technique is to cut holes 910 in stainless steel and overmold with ABS. The hole 910 may be shaped as a slot, and the slot may be inclined with respect to the basic thrust and rotational forces. The chute 910 may provide additional fixation in multiple dimensions. The ABS has a shrinkage, so a technique that limits play between the ABS and stainless steel may be advantageous. The attachment slot 910 may be used at a variety of points, such as at the base of the outer sheath/trocar 102 to which the base cup of the outer sheath/trocar 102 is mounted, in the nose of an endoscope at the base of the endoscope insertion shaft/inner sheath/cannula, and attach the endoscope deflector to the distal end of the insertion shaft.

XI.B. connecting the constituent parts of the obturator

Referring to fig. 9F, 9G, 9H and 9I, the handle/cover of the obturator 104 may be hollow to reduce weight and material costs. The shaft of the obturator 104 may be made of solid stainless steel as it is used to force the puncture inlet into the patient's tissue. As shown in fig. 9E, a circumferential groove 930 may be turned in the handle/proximal end of the obturator shaft, or two parallel cuts 930 may be milled. The base 932 of the obturator cover may then be over-molded onto the proximal end. The handle shell 934 may then be ultrasonically welded 936 to the base portion. Advantages include reduced material usage, thereby reducing weight and cost. Ultrasonic welding can join the outer shell to the inner base of the handle without the need for small metal parts that might be moved into the patient, nor the use of adhesives that might be toxic.

Fig. 9H shows a male energy director and fig. 9G shows a female slot. After ultrasonic welding 936, the two components are melted together as shown in FIG. 9I.

Twist-lock the parts together

Referring to fig. 1C, 9J, 9K and 9L, a keyway 940 on the bayonet of the obturator handle may receive a key 942 on the inside of the mounting cap of the outer sheath/trocar 102 that locks the two together during the lancing step. Ramp 944 may be about 3 ° to draw the components together. Likewise, one or more keyways on the bayonet on the endoscope nose may engage one or more pins on the inside of the mounting cap of the outer sheath/trocar 102 to lock them together during viewing use of the endoscope. The key and the key ways of the three parts may be designed to be compatible and interchangeable with each other. This may reduce manufacturing costs and may reduce handling during surgery.

XII. Examples

Embodiments of the invention may include any one or more of the following features, alone or in any combination.

The endoscope 100 may have a handle and an insertion shaft with a solid-state camera at its distal end. The insertion shaft may have solid state illumination and imaging circuitry at or near the distal end designed to provide the surgeon with illumination and imaging of the interior of the body cavity during surgery. The proximal portion of the handle may have electronics for driving the illumination circuit and receiving imaging signals from the imaging circuit. The proximal handle portion may be designed to allow for sterilization between uses. The joint between the proximal handle portion and the insertion shaft may be designed to detachably connect the insertion shaft to the proximal handle portion. The connector may allow removal of the insertion shaft for disposal and replacement when it is separated. The connector may be designed such that when connected, the connector can transfer mechanical forces from the surgeon's hand to the insertion shaft and provide an electrical connection between the proximal handle circuitry and the illumination and imaging circuitry. The handle may have proximal and distal portions. The distal portion may be located between the insertion shaft and the proximal handle portion. The insertion shaft may be rigidly fixed (attached) to the distal handle portion. The tabs may be configured to connect and disconnect the distal and proximal portions of the handle. The distal handle portion may be designed to indirectly transfer mechanical forces between the surgeon's hand and the insertion shaft and to provide an indirect electrical connection between the proximal handle circuitry and the illumination and imaging circuitry. The handle may have a rotating collar with surface features designed to assist the surgeon in rotating the insertion shaft about the axis of the insertion shaft in a rotational dimension (roll dimension) relative to the proximal handle portion. Electronics within the proximal handle portion may be configured to sense rotation of the insertion shaft and provide an angular rotation signal configured to allow correction of a display image received from the imaging circuitry. The mount for the image sensor may be designed to allow panning of the image sensor about a pitch or yaw axis perpendicular to the central axis of the insertion shaft. The one or more ultraviolet LEDs inside the endoscope may be designed to sterilize the area inside the endoscope. The hose for irrigation/insufflation liquid or gas may be designed to be located on or near the central axis of the proximal handle portion. Two or more insertion shafts, each having a different size from each other, may each be connectable to the proximal handle portion at the joint to allow for use of the proximal handle in procedures requiring different requirements for the insertion shafts. The sterilizer can be designed to sterilize components of the endoscope. The insertion shaft of the endoscope tip has a rigid proximal portion and a distal portion. The distal portion is bendable to direct the field of view of the imaging circuitry in a desired direction. The illuminator and solid state imaging circuitry are located at or near a distal tip of the articulatable distal portion. The illuminator is designed to illuminate the interior of the body cavity for the surgeon during surgery, and the imaging circuitry is designed to capture images of the interior of the body cavity. The coupling of the interchangeable endoscope tip is designed to detachably connect the insertion shaft to the handle portion at the joint and disconnect the joint. The coupling has a mechanical connector. When the connectors are disconnected, the mechanical connector allows the insertion shaft to be removed from the handle for disposal and replacement. When the joint is connected, the joint is designed to provide mechanical force transmission between the surgeon's hand and the insertion shaft. The electrical connector is designed to connect the insertion shaft to electronics in the handle. The handle electronics are designed to drive the illuminator and receive imaging signals from the imaging circuitry, and the handle is designed to allow sterilization during use. The control force transfer element is designed to allow the surgeon to direct the direction of the imaging circuitry by transferring surgeon-directed mechanical forces to the articulatable distal portion. The distal bendable portion comprises a series of articulating rigid sections. The sheath or cover over the hinged rigid section is designed to reduce intrusion or extrusion. The distal bendable portion is formed of a solid member that is bendable in its lateral and height dimensions and relatively incompressible when compressed in its longitudinal dimension. The distal bendable portion may extend from and retract into the solid sheath. The distal bendable portion is bendable in one dimension. The distal bendable portion is bendable in two orthogonal dimensions. The imaging circuitry is mounted at or near the distal tip of the articulatable distal portion by a tele-able mount. The tele-able mount is designed as two sides of a parallelogram. The imaging circuitry is mounted on a structural section hinged to both sides of the parallelogram. The passages and holes are designed to pass irrigation fluid to improve the field of view of the imaging circuitry from the lens or window. The passageway and aperture are designed to pass inflation fluid to enlarge the surgical cavity. The mechanical connector of the coupling includes a twist lock designed to secure the endoscope insertion shaft to the handle portion. A plurality of endoscope tips are bundled and packaged together by a handle. The handle has electronics designed to drive the illuminator and receive imaging signals from the imaging circuitry. The plurality of ends and handles are packaged for integrated transport and sale. The illuminator is an illumination LED mounted at or near the distal tip. The illuminator is the exit end of an optical fiber driven by an illumination source in the handle. The camera 410 may be enclosed within a plastic housing. The plastic housing may be formed as an overmolded shell designed to protect the camera 410 from body fluids and structurally retain the end components in an operative configuration. The overmolded housing may be designed to maintain the transparent window in a configuration that operates with the camera 410. The overmolded component may be formed of a transparent plastic. The over-molded component may be designed to act as a lens for the camera 410. The camera 410 may be mounted on a flexible circuit board 416. The flexible circuit board 416 may mount illumination LEDs. LEDs and cameras may be mounted on opposite sides of the flexible circuit board 416. The camera 410 may be protected behind a transparent window. The window may be molded to two thicknesses, a thinner portion designed to mount and allow illumination light to pass through, and a thicker portion located on the camera 410. The handle may contain a circuit board with circuitry for controlling and receiving signals from the camera 410. The handle and its components may be designed without metal fasteners, nor adhesive, except for those captured by over-molding. The control button of the endoscope may be molded with protrusions that act as return springs. The protrusions may be adhered into the endoscope handle by melting. The circuit board may be overmolded with plastic that encapsulates the circuit board from contact with water. The circuit board may be mounted into the handle by fusing. The parts of the handle may be joined to one another by melting into a unitary structure. The parts of the handle may be joined by a resilient clip designed to hold the two parts to each other prior to joining into a unitary structure by melting. The handle may be formed of two shells concentric with each other. Rotation of the two shells relative to each other may be controlled by one or more O-rings in frictional engagement with the two respective shells. The handle may be overmolded with a layer of high friction elastomer. The insertion shaft may be connected to the handle via a detachable joint. The water fitting of the separable fitting may be molded for interference sealing without the use of an O-ring. The water chamber of the separable joint may be designed to swirl water flowing from the handle to the insertion shaft. The insertion shaft may be formed of stainless steel and connected to the handle by a separable joint. The plastic component of the endoscope can be coupled to the insertion shaft by over-molding the plastic into the grooves aligned at an oblique angle in the wall of the insertion shaft, without the need for an adhesive. The water joint may be formed as two cones of an interference fit. The cone may interfere at large diameters. The cones may interfere by raised ridges on the lips of the female cone. The obturator 104 may be designed to pierce tissue for introduction into an endoscope. The features used to twist lock the obturator 104 into the trocar 102 may be compatible with the features used to twist lock an endoscope into the trocar.

The endoscope may have a handle and an insertion shaft. The insertion shaft has solid state illumination and imaging circuitry at or near the distal end designed to provide the surgeon with illumination and imaging of the interior of the body cavity during surgery. The proximal portion of the handle has electronics for driving the illumination circuit and receiving imaging signals from the imaging circuit, the proximal handle portion being designed to allow sterilization between uses. The joint between the proximal handle portion and the insertion shaft is designed to detachably connect the insertion shaft to the proximal handle portion. The connector allows removal of the insertion shaft for disposal and replacement when it is separated. The connector is designed such that, when connected, it is capable of transmitting mechanical forces from the surgeon's hand to the insertion shaft and providing an electrical connection between the proximal handle circuitry and the illumination and imaging circuitry.

Embodiments of the invention may include one or more of the following features. The handle may have proximal and distal portions. The distal portion may be located between the insertion shaft and the proximal handle portion. The insertion shaft may be rigidly fixed (attached) to the distal handle portion. The tabs may be configured to connect and disconnect the distal and proximal portions of the handle. The distal handle portion may be designed to indirectly transfer mechanical forces between the surgeon's hand and the insertion shaft and to provide an indirect electrical connection between the proximal handle circuitry and the illumination and imaging circuitry. The handle may have a rotating collar with surface features designed to assist the surgeon in rotating the insertion shaft about the axis of the insertion shaft in a rotational dimension relative to the proximal handle portion. Electronics within the proximal handle portion may be configured to sense rotation of the insertion shaft and provide an angular rotation signal configured to allow correction of a display image received from the imaging circuitry. The mount for the image sensor may be designed to allow panning of the image sensor about a pitch or yaw axis perpendicular to the central axis of the insertion shaft. The one or more ultraviolet LEDs inside the endoscope may be designed to sterilize the area inside the endoscope. The hose for blowing in liquid or gas may be designed to be located on or near the central axis of the proximal handle portion. Two or more insertion shafts, each having a different size from each other, may each be connectable to the proximal handle portion at the joint to allow for use of the proximal handle in procedures requiring different requirements for the insertion shafts. The sterilizer can be designed to sterilize components of the endoscope.

The endoscope may have a handle and an insertion shaft. The insertion shaft may have a solid-state camera at its distal end. The camera 410 may be enclosed within a plastic housing having an overmolded shell designed to protect the camera 410 from bodily fluids and structurally retain the end components in an operational configuration. The camera 410 may be protected behind a transparent window. The window may be molded to two thicknesses, a thinner portion designed to mount and allow illumination light to pass through, and a thicker portion located on the camera 410. The handle may be held within a circuit board having circuitry for controlling and receiving signals from the camera 410. The handle and its components can be designed without metal fasteners, nor with adhesives, except for those captured by overmolding. The handle may be formed of two shells concentric with each other. Rotation of the two shells relative to each other may be controlled by one or more O-rings that frictionally engage the two corresponding shells. The handle may have an overmolded layer of high friction elastomer. The insertion shaft may be connected to the handle by a separable joint, the water joint of which may be molded for interference sealing without the use of an O-ring. The insertion shaft may be connected to the handle via a detachable joint. The water chamber of the separable joint may be designed to swirl water flowing from the handle to the insertion shaft. The insertion shaft may be formed of stainless steel and connected to the handle by a separable joint. The plastic component of the endoscope can be coupled to the insertion shaft by over-molding the plastic into the grooves aligned at an oblique angle in the wall of the insertion shaft, without the need for an adhesive. The insertion shaft may be connected to the handle via a detachable joint. The obturator 104 may be designed to pierce tissue for introduction into an endoscope. The features used to twist lock the obturator 104 into the trocar 102 may be compatible with the features used to twist lock an endoscope into the trocar 102.

The overmolded housing may be designed to maintain the transparent window in a configuration that operates with the camera 410. The over-molded component may be formed of transparent plastic and designed to act as a lens for the camera 410. The camera 410 may be mounted on a flexible circuit board. The flexible circuit board 416 may have an illumination LED mounted thereon. LEDs and cameras may be mounted on opposite sides of the flexible circuit board 416. The control button of the endoscope may be molded with protrusions that act as return springs that attach into the handle of the endoscope by melting. The circuit board may be overmolded with a plastic that encapsulates the circuit board from contact with water. The circuit board may be mounted into the handle by fusing. The parts of the handle may be joined to one another by melting into a unitary structure. The parts of the handle may be further connected by means of a resilient clip designed to hold the two parts to each other before being joined into a unitary structure by melting. The fitting may be formed as two interference fit truncated cones. The two truncated cones may interfere at their large diameter. The truncated body may interfere by a ridge raised on the lip of the female cone.

The endoscope may have a handle and an insertion shaft. The insertion shaft has solid state illumination and imaging circuitry at or near the distal end designed to provide the surgeon with illumination and imaging of the interior of the body cavity during surgery. The proximal portion of the handle has electronics for driving the illumination circuit and receiving imaging signals from the imaging circuit, and the proximal handle portion may be designed to allow sterilization between uses. The joint between the proximal handle portion and the insertion shaft is designed to detachably connect the insertion shaft to the proximal handle portion. The connector allows removal of the insertion shaft for disposal and replacement when it is separated. The connector is designed such that, when connected, it is capable of transmitting mechanical forces from the surgeon's hand to the insertion shaft and providing an electrical connection between the proximal handle circuitry and the illumination and imaging circuitry.

The endoscope may have a handle and an insertion shaft. The insertion shaft has solid state illumination and imaging circuitry at or near the distal end designed to provide the surgeon with illumination and imaging of the interior of the body cavity during surgery. The proximal portion of the handle has electronics for driving the illumination circuit and receiving imaging signals from the imaging circuit. The proximal handle portion may be designed to allow sterilization between uses. The joint between the proximal handle portion and the insertion shaft is designed to detachably connect the insertion shaft to the proximal handle portion. The connectors may be separated to allow removal of the insertion shaft for disposal and replacement. The connector may be reconnected with a new insertion shaft, the connection designed to transfer mechanical forces from the surgeon's hand to the insertion shaft, and provide an electrical connection between the proximal handle circuitry and the illumination and imaging circuitry.

A replaceable endoscope tip for an endoscope may have a rigid proximal portion and a distal portion. The distal portion may be bendable to direct the field of view of the imaging circuitry in a desired direction. The illuminator and solid state imaging circuitry may be located at or near a distal tip of the articulatable distal portion. The illuminator may be designed to illuminate the interior of the body cavity for the surgeon during the procedure, and the imaging circuitry may be designed to capture an image of the interior of the body cavity. The coupling is designed to detachably connect the replaceable endoscope tip to the handle portion at the joint, and disconnect the joint. The coupling has a mechanical connector designed to: (a) Upon detachment, the mechanical connector allows the interchangeable endoscope tip to be removed from the handle for disposal and replacement; (b) When connected, the joint is designed to provide mechanical force transmission between the surgeon's hand and the insertion shaft. The electrical connector is designed to connect the replaceable endoscope tip to electronics in the handle, which is designed to drive the illuminator and receive imaging signals from the imaging circuitry, and which can be designed to allow sterilization between uses. The control force transmitting element is designed to allow the surgeon to direct the direction of the imaging circuitry by transmitting a surgeon-directed mechanical force to the bendable distal portion.

The optical prism may be designed to shift the field of view offset angle of the endoscope. The connector is designed to secure the optical prism to the distal end of an endoscope having a field of view displaced from the endoscope axis at an initial displacement angle and to hold the optical prism against the displacement force during insertion of the endoscope into a body cavity. The optical prism and connector are designed to reduce the angle of deflection of the endoscope field of view toward coaxial relative to the initial deflection when the prism and connector are secured to the optical end of the endoscope. The endoscope may be inserted into a body cavity. The endoscope has a field of view displaced from the endoscope axis at an initial displacement angle. The endoscope has an optical prism fixed at its distal end, which is designed to reduce the offset angle of the endoscope towards the coaxial field of view relative to the initial offset. The prism is secured to the distal end of the endoscope by a connector designed to hold the optical prism against displacement forces during insertion of the endoscope into the body cavity. The endoscope is removed from the body with the prism secured. The prism is removed from the endoscope. The endoscope is reinserted into the body cavity with its field of view at the initial offset angle. The optical prism may be designed to reduce the offset angle of the endoscope field of view to no more than 10 °, or no more than 5 °, or no more than 3 °. The optical prism may be optically convex to magnify the image. The optical prism may be optically concave to expand the field of view of the endoscope. The connector may be designed to be secured to the endoscope by mechanical force. The filter may be coupled with a prism. The endoscope may have a wetted surface designed to entrain anti-stick lubricant in a layer on the lens or window of the endoscope. The wetted surface may be a porous solid. The porous solid may be formed by sintering or other heating of the particles. The optical prism and connector may be secured to the endoscope for shipping and designed to hold the anti-stick lubricant in contact with the lens or window of the endoscope during shipping. The vial, aperture or cavity may have a cap with a seal to seal around the shaft of the endoscope. The anti-stick lubricant may comprise silicone oil or a mixture thereof. The anti-stick lubricant may comprise a mixture of silicone oils of different viscosities. The vial or cavity may include an optical prism designed to shift the field of view of the upper endoscope.

Packages for endoscopes may have mechanical features designed to hold components of the endoscope and to protect the endoscope for transport and/or delivery. The package has a vial, aperture or cavity designed to hold the anti-stick lubricant in contact with the lens or window of the endoscope.

The distal bendable portion may comprise a series of articulating rigid sections. The sheath or cover may cover a hinged rigid section designed to reduce intrusion or extrusion. The distal bendable portion may be formed of a solid member that is bendable in its lateral and height dimensions and relatively incompressible when compressed in its longitudinal dimension. The distal bendable portion may extend from and retract into the solid sheath. The distal bendable portion may be bendable in one dimension. The distal bendable portion may be bendable in two orthogonal dimensions. The imaging circuitry may be mounted at or near a distal tip of the bendable distal portion by a tele-able mount. The tele-able mount may be designed as two sides of a parallelogram and the imaging circuitry may be mounted on a structural section hinged to the two sides of the parallelogram. The passages and holes may be designed to pass irrigation fluid to improve the field of view of the imaging circuitry from the lens or window. The passageway and aperture may be designed to pass inflation fluid to enlarge the surgical cavity. The mechanical connector of the coupling may include a twist lock designed to secure the replaceable endoscope tip of the endoscope to the handle portion. The replaceable endoscope tips of multiple endoscopes may be packaged for integrated transport and sale with a reusable handle having electronics designed to drive the illuminator and receive imaging signals from the imaging circuitry. The illuminator may be an illumination LED mounted at or near the distal tip. The illuminator may be an exit end of an optical fiber driven by an illumination source in the handle.

The arthroscope has a handle and an insertion shaft. The insertion shaft may have a solid-state camera near its distal end. The shaft has at least one light conductor encapsulated therein, the light conductor being designed to conduct illumination light to the distal end. The outer diameter of the shaft is no greater than 6 mm. The shaft may have rigidity and strength for inserting the camera into the joint for arthroscopic surgery. The light guide in the region of the camera may be designed to conduct illumination light from the optical fiber to the distal end via the space between the camera and the inner surface of the insertion shaft.

The optical fiber may have a flattened region shaped to be located between the endoscope camera and an inner surface of an outer wall of the endoscope shaft and shaped to conduct illumination light to a distal end of the endoscope shaft to illuminate a surgical cavity to be viewed by the camera. The diameter of the shaft may not exceed 6 mm. The flattened region is formed by heating a region of the plastic optical fiber and pressing the heated region in a polished die.

Preferred embodiments may have one or more of the following features. One or more light guides may be designed to conduct illumination light from the optical fiber to the distal end. The light guide may have a cross-section other than circular. The light guide may have a coupler to receive illumination light from a circular cross-section fiber. The cross section of the light guide in the region of the camera is narrower than the diameter of the optical fiber in the dimension of the light guide corresponding to the radius of the insertion axis. At least one of the inner and outer surfaces of the one or more light guides may be longitudinally fluted. The distal surface of the one or more light guides or flattened regions may be designed to diffuse the exiting light. The distal surface of one or more light guides may have surface micro-domes designed to diffuse the exiting light, or may be otherwise configured to improve the uniformity of illumination into the surgical cavity for arthroscopic access. One or more of the optical conductors in the region of the camera may be formed as flattened regions of optical fibers. The flattened area may be shaped to lie between the endoscope camera and an inner surface of an outer wall of the endoscope shaft. The flattened area may be shaped to direct illumination light to the distal end of the endoscope shaft to illuminate a surgical cavity to be viewed by the camera. The outer diameter of the shaft may not exceed 6 mm. The flattened region may be formed by heating a region of the plastic optical fiber. The flattened regions may be formed by extruding the optical fibers in a polished die. The components for mounting near the distal end of the endoscope may be shaped using error-proofing design principles to ensure proper assembly. The component parts of the lens assembly for mounting near the distal end may be shaped using error-proofing design principles to ensure proper assembly. The component parts near the distal end may be formed to allow adjustment of the focus of the lens assembly during manufacturing. The endoscope may have a terminal window designed to seal with the shaft to prevent intrusion of body fluids, body tissues, and/or infusion fluids. The termination window may be designed to reduce optical artifacts. Artifacts that may be reduced may be reflections, light leakage within the endoscope, contamination by body fluids and/or body tissue, and fogging. The optical conductor in the region of the camera may comprise at least nine substantially continuous diameter optical fibers from the light source, the optical fibers having a diameter of no more than about 0.5 millimeters and being arranged opposite at least 250 ° of the circumference of the distal end of the endoscope. The arthroscopic insertion shaft may have a solid-state camera near its distal end. The shaft may have a light conductor encapsulated therein, the light conductor being designed to conduct illumination light to the distal end. The shaft may have rigidity and strength for inserting a camera into a joint for arthroscopic surgery. The flattened region may be sized to conduct illumination light from the optical fiber to the distal end via a space between the camera and an inner surface of the insertion shaft.

The various processes described herein may be implemented by suitably programmed general purpose computers, special purpose computers, and computing devices. Typically, a processor (e.g., one or more microprocessors, one or more microcontrollers, one or more digital signal processors) will receive instructions (e.g., from a memory or similar device) and execute those instructions, thereby performing one or more processes defined by those instructions. The instructions may be embodied by one or more computer programs, one or more scripts, or other forms. The processing may be performed on one or more microprocessors, central Processing Units (CPUs), computing devices, microcontrollers, digital signal processors, or the like, or any combination thereof. Various media may be used to store and transmit programs that implement the processes, as well as data operated upon. In some cases, hard-wired circuitry or custom hardware may be used in place of or in combination with software instructions in which some or all of these processes may be implemented. Algorithms other than those described may be used.

The programs and data may be stored in various media suitable for the purpose or a combination of heterogeneous media that can be read and/or written by a computer, processor, or similar device. The media may include non-volatile media, optical or magnetic media, dynamic Random Access Memory (DRAM), static memory, floppy disk, hard disk, magnetic tape, any other magnetic media, CD-ROM, DVD, any other optical media, punch cards, paper tape, any other physical media with patterns of holes, RAM, PROM, EPROM, FLASH-EEPROM, any other memory chip or cartridge, or other memory technology.

The database may be implemented using a database management system or a temporary memory organization scheme. Alternative database structures to the described database structure may be readily employed. The database may be stored locally or remotely in a device accessing data in such a database.

In some cases, the process may be performed in a network environment that includes a computer in communication with one or more devices (e.g., via a communication network). The computer may communicate with the devices directly or indirectly through any wired or wireless medium such as Internet, LAN, WAN or ethernet, token ring, telephone line, cable, radio channel, optical communication line, commercial online service provider, bulletin board system, satellite communication link, or any combination of the preceding. Transmission media include coaxial cables, copper wire and fiber optics, including the wires that comprise a system bus coupled to the processor. Transmission may occur through a transmission medium or through electromagnetic waves (e.g., through infrared, wiFi, bluetooth, etc.) using various protocols at various frequencies. Each device may itself comprise a computer or other computing device adapted to communicate with the computer, e.g., based onOr a computer or other computing device of a Centrino ^TM processor. Any number and type of devices may be in communication with the computer.

A server computer or centralized rights management authority may or may not be necessary and desirable. In various cases, the network may or may not include a central rights device. The various processing functions may be performed on a central rights server, one of a plurality of distributed servers, or other distributed devices.

The following applications are incorporated by reference. U.S. patent application Ser. No. 17/824,857, entitled "endoscope," filed 5/25/2022; U.S. provisional patent application No. 63/249,479, entitled "endoscope," filed on 28, 9, 2021; U.S. provisional patent application No. 63/237,906 entitled "endoscope," filed on 8.27 of 2021; U.S. patent application Ser. No. 17/361,711, entitled "endoscope with Flexible Camera shaft," filed on 6/29 of 2021; U.S. provisional patent application No. 63/214,296, entitled "endoscope with bendable camera shaft", filed on 24, 6, 2021; U.S. provisional patent application No. 63/193,387 entitled "anti-stick window or lens for endoscope tip"; U.S. provisional patent application No. 63/067,781 entitled "endoscope with articulating camera shaft" filed on day 19, 8, 2020; U.S. provisional patent application No. 63/047,588, entitled "endoscope with articulating camera shaft", filed on 7/2/2020; U.S. provisional patent application No. 63/046,665 entitled "endoscope with articulating camera shaft" filed on 6/30 th 2020; U.S. patent application Ser. No. 16/434,766, filed on 7/6/2019, entitled "endoscope with disposable Camera shaft and reusable handle"; U.S. provisional patent application No. 62/850,326 entitled "endoscope with disposable camera shaft" filed on 5/20 of 2019; U.S. patent application Ser. No. 16/069,220 entitled "anti-fouling endoscope and its use", filed on 10/24/2018; U.S. provisional patent application No. 62/722,150 entitled "endoscope with disposable camera shaft" filed on day 23, 8, 2018; U.S. provisional patent application No. 62/682,585 entitled "endoscope with disposable camera shaft" filed on 6/8/2018.

For the purposes of clarity, the foregoing description focuses on a representative example of all possible embodiments, which teaches the principles of the invention and conveys the best mode contemplated for carrying out the invention. The invention is not limited to the described embodiments. Well-known features may not have been described in detail to avoid unnecessarily obscuring the principles associated with the claimed invention. Throughout this application and its related document history, when the term "invention" is used, it refers to the complete set of concepts and principles described; rather, a formal definition of the specific protection property is set forth in the claims, which control the formal definition exclusively. This description is not intended to be exhaustive of all possible variations. Other variations or modifications not described are possible. When multiple alternative embodiments are described, elements of different embodiments may be combined in many instances, or elements of embodiments described herein may be combined with other modifications or variations not explicitly described. The list of items does not imply that any or all of the items are mutually exclusive, nor that any or all of the items are comprehensive items of any category, unless explicitly stated otherwise. In many cases, a feature or set of features may be used separately from the entire apparatus or method described. Many alternatives, variations, modifications, and equivalents not described are intended to be included within the literal scope of the appended claims, while others are equivalent. The claims may be practiced without some or all of the specific details described in the specification. In many cases, the method steps described in this specification can be performed in a different order than presented in this specification, or performed in parallel rather than sequentially.

Claims

1. An arthroscope, comprising:

A handle and an insertion shaft having a solid-state camera near its distal end, the shaft having at least one light conductor enclosed therein, the light conductor being designed to conduct illumination light to the distal end, the shaft having an outer diameter of no more than 6 millimeters, the shaft having rigidity and strength for inserting the camera into a joint for arthroscopic surgery;

The light guide in the region of the camera is designed to conduct illumination light from the optical fiber to the distal end via the space between the camera and the inner surface of the insertion shaft.

2. The arthroscope of claim 1, further comprising:

One or more light guides designed to conduct illumination light from an optical fiber to the distal end, the light guides having a cross-section other than circular, the light guides having couplers to receive illumination light from a circular cross-section optical fiber, the cross-section of the light guides in the region of the camera being narrower than the diameter of the optical fiber in a light guide dimension corresponding to the radius of the insertion axis.

3. The arthroscope of claim 2, wherein:

at least one of the inner and outer surfaces of the one or more light guides is longitudinally fluted.

4. The arthroscope of claim 2, wherein:

the distal surface of the one or more light guides is designed to diffuse the exiting light.

5. The arthroscope of claim 4, wherein:

the distal surface of the one or more light guides has surface micro-domes designed to diffuse the exiting light.

6. The arthroscope of claim 1:

The light guide in the region of the camera is formed as a flattened region of optical fiber shaped to lie between the endoscope camera and the inner surface of the outer wall of the endoscope shaft and shaped to conduct illumination light to the distal end of the endoscope shaft to illuminate a surgical cavity to be viewed through the camera, the shaft having a diameter of no more than 6 millimeters;

The flattened region is formed by heating a region of the plastic optical fiber and pressing the heated region in a polished die.

7. The arthroscope of claim 1:

the optical conductor in the region of the camera is formed by heating the region of the plastic optical fiber and pressing the heated region in a polished mold.

8. The arthroscope of claim 7, wherein:

at least one of the inner and outer surfaces of the flattened region is longitudinally fluted.

9. The arthroscope of claim 1:

the components for mounting near the distal end are shaped using error-proofing design principles to ensure proper assembly.

10. The arthroscope of claim 1:

The component parts of the lens assembly for mounting near the distal end are shaped using error-proofing design principles to ensure proper assembly.

11. The arthroscope of claim 1:

the component parts near the distal end are formed to allow adjustment of the focus of the lens assembly during manufacture.

12. The arthroscope of claim 1, further comprising:

a terminal window designed to seal with the shaft to prevent intrusion of body fluids, body tissues and/or infusion fluids.

13. The arthroscope of claim 1, further comprising:

A terminal window designed to reduce optical artifacts, including one or more artifacts from the group consisting of reflections, light leakage within the endoscope, contamination by bodily fluids and/or body tissue, and fogging.

14. The arthroscope of claim 1, wherein:

the light guide in the region of the camera comprises at least nine substantially continuous diameter optical fibers from the light source, the optical fibers having a diameter of no more than about 0.5 millimeters and being arranged opposite at least 250 ° of the circumference of the distal end of the endoscope.

15. An optical fiber, comprising:

A flattened region shaped to lie between an endoscope camera and an inner surface of an outer wall of an endoscope shaft, the shaft having a diameter of no more than 6 millimeters, the flattened region being shaped to conduct illumination light to a distal end of the endoscope shaft via a space between the camera and the inner surface of another wall to illuminate a surgical cavity to be viewed by the camera;

16. The optical fiber of claim 15, further comprising:

An arthroscopic handle and an arthroscopic insertion shaft, the insertion shaft having a solid-state camera near a distal end thereof, the shaft having the optical fiber enclosed therein, the optical fiber being arranged to conduct illumination light to the distal end, the shaft having an outer diameter of no more than 6 millimeters, the shaft having rigidity and strength for inserting the camera into a joint for arthroscopic surgery;

The flattened region is sized to conduct illumination light from an optical fiber to the distal end via a space between the camera and an inner surface of the insertion shaft.

17. The optical fiber of claim 15:

The distal end of the flattened region has a surface designed to diffuse light into the surgical cavity.

18. The optical fiber of claim 15, wherein:

19. The optical fiber of claim 15, wherein:

20. The optical fiber of claim 19, wherein:

21. The optical fiber of claim 15, wherein: