Camera module and flexible circuit board for an elongated interventional device - Patent Application 20070122999

Abstract

The present invention provides a camera module for installation on an elongated interventional device, comprising a base having a body, at least one camera flexible printed circuit board (camera FCB) attached to the base, and one or more cameras positioned on the at least one camera FCB and on the body.

Description

[Technical Field]

[0001] Related Applications This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 438,583, filed January 12, 2023, the contents of which are incorporated herein by reference in their entirety.

[0002] In some embodiments thereof, the present invention relates to a method for manufacturing an apparatus for an elongated interventional device and components for an elongated interventional device, and more particularly, but not exclusively, to a method for manufacturing an apparatus for an elongated interventional device and components related to video and / or steering for an elongated interventional device. [Background technology]

[0003] Many interventional devices exist that are inserted into physical lumens and are configured as elongated devices for insertion into physical lumens. Because these devices must pass through tight spaces, their outer diameters must be small. Furthermore, these devices often include an internal lumen or working channel that is used to perform procedural operations (e.g., suction and / or flushing) and to insert instruments such as biopsies. This working channel must be as large as possible, which places significant size requirements on the cross-section of the device.

[0004] Additionally, many devices include a camera at the distal tip of the device, which helps the user orient themselves within the anatomy and provides diagnostic capabilities. The camera may be positioned at any angle relative to the axis of the device, but is most commonly aligned parallel to the axis of the device, facing forward. Such cameras consist of a sensor, e.g., a CCD or CMOS, and typically require illumination. Illumination is typically provided by additional components, e.g., LEDs. The camera and / or LEDs require a power source and a way to transmit an image signal back to the processor. Due to size constraints, this signal (analog or digital) is typically sent to a separate processor located some distance from the camera, e.g., in the device handle or a separate control. For these reasons, the camera and / or LEDs are mounted on a PCB. The PCB is connected to cables or wires that connect the camera and / or LEDs to the power source and processor.

[0005] Some devices may also include other types of sensors at the distal tip, such as force, temperature, pressure, or electromagnetic sensors, to provide diagnostic feedback or to assist the user in navigation, for example, in the case of electromagnetic sensors used as part of an electromagnetic tracking system. In either case, these sensors, like cameras, require electrical connections to a power source and a way to connect to a drive or processor.

[0006] Additionally, many devices also have steering capabilities, meaning that the distal end of the device can be used to deflect the tip of the device in a selected direction. This is most commonly accomplished by using one or more steering wires that run inside the wall of the device and are anchored to the distal tip. Pulling the wire causes the device to deflect in the direction of the wire.

[0007] When navigating through anatomical structures, it is beneficial to have a deflection section near the distal end of the device. Having a long straight section distal to the deflection section can limit the ability to navigate. On the other hand, a rigid, inflexible camera must be mounted on the most distal surface of the device, creating a straight section at the distal end. Often, due to geometric considerations, manufacturing considerations, or other reasons, the camera is mounted distal to where the steering wires are anchored, further increasing the length of the straight section at the distal end of the device.

[0008] Patent Document 1 describes an interventional device with integrated electronics. Specifically, a device with an FCB helically wound around the device's working channel has several advantages, such as the ability to maintain and control the device's mechanical properties. Adding a camera aligned with the longitudinal axis of an elongated device requires mounting on the FCB perpendicular to that axis. Therefore, it would be beneficial to design a camera module with an FPC mounted perpendicular to the longitudinal axis that is folded or wrapped around the working channel of the interventional device. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] International Patent Application No. PCT / IL2023 / 051072 Summary of the Invention [Problem to be solved by the invention]

[0010] Some interventional devices further incorporate sensors that are used to track the position of the device, for example, by measuring electromagnetic fields. Tracking the distal tip of the device in particular can be very beneficial. To improve the accuracy of the measurements, it is preferable to position the position sensor as close as possible to the tip of the device.

[0011] It would therefore be beneficial to design a camera module that can accommodate a camera, lighting device, and / or additional sensors, that can provide a way to connect the camera, lighting device, and / or additional sensors to a power source and processing unit, that can provide a way to secure the steering wire(s), that can support helical winding of the FCB(s) around the working channel, that can include an additional sensor(s), e.g., a position sensor, and that is packaged in a minimal length while maintaining outer and inner diameter requirements. [Means for solving the problem]

[0012] Below is a non-exhaustive list including some example embodiments of the present invention. The present invention also includes embodiments that include fewer than all of the features of the example embodiments or that use features from more than one example embodiment, even if not explicitly listed below.

[0013] Example 1. A camera module for installation on an elongated interventional device, comprising: a. a base having a body; b. at least one camera flexible printed circuit board (FCB) attached to the base; c. one or more cameras positioned on said at least one camera FCB and on said body; A camera module comprising:

[0014] Example 2. The method further comprises at least one protrusion positioned on the body of the base. The camera module according to Example 1.

[0015] Example 3. The one or more cameras are positioned on the at least one protrusion. The camera module according to the first or second embodiment.

[0016] Example 4. The base further comprises at least one channel sized and shaped to match the working channel of the elongate interventional device. The camera module according to any one of the first to third embodiments.

[0017] Example 5. The at least one protrusion has a distal surface and a proximal surface. The camera module according to any one of the first to fourth embodiments.

[0018] Example 6. The one or more cameras are positioned on the distal surface of the convex portion. The camera module according to any one of the first to fifth embodiments.

[0019] Example 7. Further comprising at least one first sensor and at least one sensor flexible printed circuit board (sensor FCB); The camera module according to any one of the first to sixth embodiments.

[0020] Example 8. The at least one first sensor is mounted on the sensor FCB. The camera module according to any one of the first to seventh embodiments.

[0021] Example 9. The at least one first sensor is positioned on the proximal surface of the protrusion. The camera module according to any one of the first to eighth embodiments.

[0022] Example 10. The method further comprises at least one second sensor positioned on the sensor FCB. The camera module according to any one of the first to ninth embodiments.

[0023] Example 11. The system further comprises at least one second sensor positioned on the camera FCB. The camera module according to any one of the first to tenth embodiments.

[0024] Example 12. The camera FCB is a. a distal head configuration; b. a neck configuration attached to the distal head configuration; c. an elongated tail attached to the neck configuration; comprising one or more of: The camera module according to any one of the first to tenth embodiments.

[0025] Example 13. The distal head configuration and the neck configuration both have a shape that matches the shape of the base. The camera module according to any one of the first to twelfth embodiments.

[0026] Example 14. The elongate tail is wound along the longitudinal axis of the base, and the longitudinal axis of the base coincides with the longitudinal axis of the elongate interventional device. The camera module according to any one of the first to thirteenth embodiments.

[0027] Example 15. The neck arrangement is configured to wrap around the base in a plane perpendicular to the longitudinal axis of the base. The camera module according to any one of the first to fourteenth embodiments.

[0028] Example 16. The winding of the elongated tail is clockwise or counterclockwise. The camera module according to any one of the first to fifteenth embodiments.

[0029] Example 17. The sensor FCB is wound along the longitudinal axis of the base, and the longitudinal axis of the base coincides with the longitudinal axis of the elongated interventional device. The camera module according to any one of the first to sixteenth embodiments.

[0030] Example 18. The elongate tail and the sensor FCB are both wound along the longitudinal axis of the base, which coincides with the longitudinal axis of the elongate interventional device. The camera module according to any one of the first to seventeenth embodiments.

[0031] Example 19. The winding of the elongated tail and the winding of the sensor FCB have the same winding direction. The camera module according to any one of Examples 1 to 18.

[0032] Example 20. The turns of the elongated tail and the turns of the sensor FCB do not overlap. The camera module according to any one of Examples 1 to 19.

[0033] Example 21. The winding of the elongated tail and the winding of the sensor FCB have different winding directions. The camera module according to any one of Examples 1 to 20.

[0034] Example 22. The windings of the elongated tail and the windings of the sensor FCB overlap. The camera module according to any one of Examples 1 to 21.

[0035] Example 23. Further comprising one or more lights positioned on the base. The camera module according to any one of Examples 1 to 22.

[0036] Example 24. The one or more lights are mounted on the distal surface of the protrusion. The camera module according to any one of Examples 1 to 23.

[0037] Example 25. The one or more lights are mounted adjacent to the one or more cameras. The camera module according to any one of Examples 1 to 24.

[0038] Example 26. The one or more lights are mounted on the camera FCB. The camera module according to any one of Examples 1 to 25.

[0039] Example 27. The base further comprises at least one connection element for at least one steering mechanism. The camera module according to any one of Examples 1 to 26.

[0040] Example 28: The at least one steering mechanism is at least one steering wire. The camera module according to any one of Examples 1 to 27.

[0041] Example 29. The at least one connecting element is one or more of a slit, a protrusion, and an anchor. The camera module according to any one of Examples 1 to 28.

[0042] Example 30. The device further includes a mold surrounding the distal end of the camera module. The camera module according to any one of Examples 1 to 29.

[0043] Example 31. The mold is configured to hold multiple components to the base of the camera module. The camera module according to any one of Examples 1 to 30.

[0044] Example 32. A camera module for installation on an elongated interventional device configured to be inserted into and navigated within a body cavity, comprising: a. a fixture having a body configured to connect to a steering wire of the elongate device and a protrusion; b. a flexible PCB having a front plate, a front fold mark, a start-of-wind fold mark, and a PCB wrappable tail, the front plate including a camera and lighting components, the flexible PCB being foldable tightly around the fixture and around the elongate device; c. a mold that holds the fixture and the flexible PCB together; A camera module comprising:

[0045] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. Furthermore, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting. [Brief explanation of the drawings]

[0046] Some embodiments of the present invention are herein described, by way of example only, with reference to the accompanying drawings. While specific reference will now be made to the drawings in detail, it is emphasized that the details shown are for the purpose of illustrating and discussing embodiments of the invention by way of example. In this regard, the description taken with the drawings will make apparent to those skilled in the art how embodiments of the invention may be practiced. [Figure 1] 1 is a schematic diagram of a commonly known elongated interventional device. [Figure 2] 1 is a schematic diagram of a general overview of an exemplary camera module according to some embodiments of the present invention. [Figure 3A] 1 is a schematic diagram of an exemplary base according to some embodiments of the present invention. [Figure 3B] 1 is a schematic diagram of an exemplary base according to some embodiments of the present invention. [Figure 4A] 1 is a schematic diagram of an exemplary camera FCB according to some embodiments of the present invention. [Figure 4B] 1 is a schematic diagram of an exemplary camera FCB according to some embodiments of the present invention. [Figure 4C] 1 is a schematic diagram of an exemplary camera FCB according to some embodiments of the present invention. [Figure 4D] 1 is a schematic diagram of an exemplary camera FCB according to some embodiments of the present invention. [Figure 4E] 1 is a schematic diagram of an exemplary camera FCB according to some embodiments of the present invention. [Figure 4F] 1 is a schematic diagram of an exemplary camera FCB according to some embodiments of the present invention. [Figure 5] FIG. 1 is a schematic diagram of an exemplary optional distal end sensor according to some embodiments of the present invention. [Figure 6A] FIG. 2 is a schematic diagram of an exemplary sensor FCB according to some embodiments of the present invention. [Figure 6B] 1A and 1B are schematic diagrams of an exemplary sensor FCB and an exemplary camera FCB according to some embodiments of the present invention. [Figure 7A] 1 is a schematic diagram of at least one steering wire for a steering mechanism in an exemplary camera module according to some embodiments of the present invention. FIG. [Figure 7B] 1 is a schematic diagram of at least one steering wire for a steering mechanism in an exemplary camera module according to some embodiments of the present invention. FIG. [Figure 7C] 1 is a schematic diagram of at least one steering wire for a steering mechanism in an exemplary camera module according to some embodiments of the present invention. FIG. [Figure 7D] 1 is a schematic diagram of at least one steering wire for a steering mechanism in an exemplary camera module according to some embodiments of the present invention. FIG. [Figure 8]1 is a schematic diagram of an exemplary mold optionally used in a camera module according to some embodiments of the present invention. [Figure 9] 1 is a flowchart of an exemplary assembly method according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0047] In some embodiments thereof, the present invention relates to a method for manufacturing an apparatus for an elongated interventional device and components for an elongated interventional device, and more particularly, but not exclusively, to a method for manufacturing an apparatus for an elongated interventional device and components related to video and / or steering for an elongated interventional device.

[0048] overview An aspect of some embodiments of the present invention relates to the configuration of the distal end of an elongate interventional device having video and / or steering capabilities. In some embodiments, the distal end is shorter in length than devices known in the art. In some embodiments, a potential advantage of a shorter distal end is that it may provide a device that is easier to manipulate within a patient. In some embodiments, this configuration allows for positioning of a camera at a specific, selected location on the distal end of the elongate interventional device without compromising steering capabilities and / or the size of the distal end. In some embodiments, a flexible printed circuit board (PCB) extending from the camera at the distal end to a handle located at the proximal end provides for proximal connection of the camera to the handle and / or computer. In some embodiments, the flexible PCB (FCB) is wrapped around and along the body of the elongate interventional device.

[0049] In some embodiments, an exemplary elongated interventional device configured to be inserted into and navigated within a body cavity is manufactured with a camera module.

[0050] In some embodiments, the camera module comprises one or more of the following elements: 1. A fixture or base (hereinafter referred to as "base") having a body and a protrusion. In some embodiments, the body has channels connecting opposing sides, and the body is configured to be connected to a steering wire of an elongate device. 2. A flexible PCB (FCB) having a front plate, a front fold mark, a start-of-winding fold mark, and an FCB windable tail. In some embodiments, the front plate includes a camera and illumination components. In some embodiments, the front plate is configured to be mounted on a first side of a protruding portion of a base. In some embodiments, the flexible PCB is foldable tightly around the base and around an elongated interventional device. 3. A mold that holds the base and flexible PCB (FCB) together.

[0051] In some embodiments, the mold secures the base and supported components in a protective and precisely aligned manner, prevents relative movement of the components, and provides electrical insulation.

[0052] In some embodiments, the camera module includes a position sensor FCB. Optionally, in some embodiments, the position sensor FCB is located on a second side of the protruding portion of the base.

[0053] In some embodiments, the base includes a groove along the periphery of its body in which the steering wire is inserted into and / or connected to and held by the base, hi some embodiments, the steering wire consists of a single wire that runs from the proximal end of the elongate device to a first side of the base, is guided through the groove to a second side of the base, and returns toward the proximal end of the elongate device.

[0054] In some embodiments, the protrusion of the base provides a surface on which components such as a camera, position sensor, and / or LEDs can be mounted without compromising the size of the channel in the body of the base. In some embodiments, the diameter of the channel corresponds to the diameter of the catheter tube at the distal end of which the camera module is mounted. In some embodiments, it is important to keep the channel clear of other components and / or allow the largest possible path diameter for various instruments to allow for uninterrupted passage of stored instruments through the catheter and camera module. Therefore, the base is configured to support components at the perimeter width of the channel and the protrusion, allowing the largest possible inner diameter of the channel.

[0055] In some embodiments, a potential advantage of having steering wires directly connected to the base is that it may provide a relatively short distal tip for the elongate interventional device. In some embodiments, this may improve the steerability and / or maneuverability of the elongate device. Also, by closely mechanically connecting the steering wires to where the camera is located, the precision and sensitivity of camera orientation may be improved.

[0056] In some embodiments, yet another potential advantage of having steering wires connected directly to the base is the potential for adding mechanical strength and stability to the overall structure and / or to the camera module mounting.

[0057] In some embodiments, the camera FCB is configured to be folded, for example, by a front fold mark so that the camera is positioned at the proper angle to capture image data in a direction aligned parallel to the longitudinal axis of the elongate device. Also, in some embodiments, the camera FCB is configured to be folded by a second fold mark, a start-of-wrap fold mark, that allows the FCB tail to wrap around the elongate device at the proper angle so that the overall structure, device, and FCB remain narrow and flexible in circumference to improve maneuverability of the device within the body cavity.

[0058] Before describing at least one embodiment of the present invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and arrangement of components and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0059] Reference is now made to Figure 1, which shows a schematic diagram of a commonly known elongated interventional device. A commonly known elongated interventional device typically comprises a proximal end 102 and a distal end 104. The proximal end 102 typically includes a handle 106 or an adapter / interface for a robotic system (not shown).

[0060] Between the handle 106 at the proximal end 102 and the distal end 104 is an elongate body 108 that extends from the handle 106 to the distal end 104 of the elongate interventional device 100. Some elongate interventional devices include a working channel 110 that extends from a location at the proximal end 102 and extends within the elongate body 108 to the distal end 104 of the elongate interventional device 100. There is typically an opening 112 (approximately located, not an actual location) that allows insertion of an instrument into the working channel, and the instrument is typically configured to extend until it reaches an exit 114 at the distal-most end 104 of the elongate interventional device 100.

[0061] The elongated interventional device may optionally include a camera 116 at the distal-most portion of the distal end 104 .

[0062] Known elongate interventional devices may also optionally include a steering mechanism including one or more wires 118. The one or more wires 118 are connected to an actuator 120 at the proximal end 102 (typically at the handle 106) and to a fixation element 122 or dedicated anchor (not shown) at the distal end 104. Actuation of the actuator 120 causes movement of the distal end 104, as indicated generally by arrow 124.

[0063] One of the unresolved technical challenges is to allow manufacturers to create a rigid, long distal end that includes all of these features, such as a camera, steering, working channel, and optional additional elements such as sensors and lights, in a single elongate interventional device, thereby enabling positioning of all of the features at the distal-most end, which is the location of interest for the elongate interventional device. The present invention overcomes the shortcomings of known elongate interventional devices by providing an elongate interventional device that has all of the above features and provides a shorter distal end that is easier to manipulate within a patient.

[0064] Exemplary Camera Module of an Exemplary Elongated Interventional Device Reference is now made to Figure 2. Figure 2 shows a schematic diagram of a general overview of an exemplary camera module according to some embodiments of the present invention.

[0065] In some embodiments, the exemplary camera module 200 comprises one or more of the following components (each of which is described in more detail below): 1. Base 202 2. One or more cameras (one shown) 204 3. At least one Camera flexible printed circuit board (Hereinafter referred to as "camera FCB (flexible printed circuit board)") 206 4. Optional distal end sensor 208 5. If there is one optional distal end sensor 208, at least one sensor flexible printed circuit board (hereinafter referred to as "sensor FCB (flexible printed circuit board)") 210 6. One or more optional additional sensors 212 located proximal to the optional distal sensor 208 7. At least one steering wire (two shown) 214 8. One or more lights (two shown, e.g., LEDs) 216 9. A mold 218 configured to hold different portions of the camera module 200, as further described below.

[0066] In some embodiments, the camera module optionally includes one or more steering cables or wires used to control the orientation of the tip of the elongate device. In some embodiments, the term "wire" hereinafter refers to a single stranded wire (having a circular, rectangular, or any other cross-section) or a cable made from multiple strands twisted, braided, or otherwise combined to form a cable.

[0067] It should be understood that the above list is an exemplary list and that other components may be added to the exemplary camera module 200, and any combination thereof may be made, all of which are intended to fall within the scope of the present invention.

[0068] In some embodiments, the exemplary camera module 200 may be mounted on and / or integrated with and / or be part of an elongated interventional device (not shown), such as a catheter, a camera probe, and / or any other elongated device, e.g., a device configured to be inserted into a body cavity directly and / or via a catheter or other tube.

[0069] Exemplary Base 202 Reference is now made to Figures 3a and 3b, which show schematic diagrams of an exemplary base 202 according to some embodiments of the present invention.

[0070] In some embodiments, the exemplary base 202 is configured to be mounted at the distal end of an elongated interventional device (not shown), e.g., such that the longitudinal axis of the camera module 200 is parallel to and / or coincides with the longitudinal axis of the elongated interventional device. In some embodiments, the base 202 is configured to support and / or connect to one or more components of the camera module 200, e.g., one or more cameras 204, at least one camera FCB 206, optional distal tip sensors 208, at least one sensor FCB 206, at least one steering wire 214, and one or more lights 216. In some embodiments, the base 202 is also configured to be covered by a mold 218, as described further below.

[0071] In some embodiments, the base 202 comprises a body 302 having a channel 304 therein. In some embodiments, the channel 304 is sized and shaped to match and / or correspond to the working channel of an elongated interventional device in which the camera module 200 is mounted.

[0072] In some embodiments, the base 202 comprises a protrusion 306 located at the distal-most end of the body 302 of the base 202. In some embodiments, the protrusion 306 extends upward, optionally perpendicular 308 to an imaginary longitudinal axis 310 of the base 202, as shown schematically in FIG.

[0073] In some embodiments, the protrusion 306 comprises a proximal side 312 and a distal side 314. In some embodiments, the one or more cameras 204 are mounted on the distal side 314 of the protrusion 306, while any distal end sensors 208 are mounted on the proximal side 312 of the protrusion 306, for example, as shown schematically in FIG.

[0074] In some embodiments, the protrusion 306 provides the necessary surface area on the base 202 for components to mount on, without compromising the size and / or shape of the channel 304. In some embodiments, a potential advantage of providing the protrusion 306, which allows the size and / or shape of the channel 304 to be provided without compromising, is that it allows instruments stored therethrough for an elongated interventional device to pass through the camera module 200 uninterrupted. Thus, in some embodiments, the channel 304 is left clear of other components of the camera module 200 to allow for the maximum path diameter for various instruments. In some embodiments, another potential advantage of providing the protrusion 306 is that it may provide a rigid surface onto which the camera FCB 206 can be attached and folded back to ensure proper alignment of the camera 204 with the longitudinal axis 310.

[0075] In some embodiments, the base 202 may have any necessary shape that allows it to provide the necessary shape for the elongated interventional device and / or provide the necessary surface area for mounting the necessary components. It should be understood that the shapes shown in Figures 3a and 3b (or elsewhere) are merely exemplary shapes provided to aid those skilled in the art in understanding the present invention and are not meant to be limiting in any way.

[0076] In some embodiments, the base is fabricated from one or more polymers, such as nylon, PEEK, PE, or other polymers compatible with interventional devices. In some embodiments, the base comprises one or more metallic materials, such as stainless steel, titanium, etc. In some embodiments, a potential advantage of using metallic materials is that metal steering wires can be directly welded to the base.

[0077] In some embodiments, the base, including the body and protrusion, is fabricated to fit within a circle having a diameter of, for example, 1.5 mm, 2 mm, 3.5 mm, 5 mm, 6 mm, etc., and a length of 1.5 mm, 2.5 mm, 4 mm, etc., that defines a working channel having a diameter of, for example, 0.5 mm, 1.6 mm, 2 mm, 3.2 mm, 5 mm, etc. In some embodiments, a potential advantage of designing the base to fit within a specific circle is that the diameter of the bounding circle may match or correspond to the outer diameter of the elongate device. In some embodiments, another potential advantage of a specific working channel size is that it may match industry standards for instrument sizes; for example, many instruments are designed to fit within a 2 mm working channel.

[0078] Exemplary One or More Cameras 204 In some embodiments, camera module 200 includes one or more cameras 204, such as a charge-coupled device (CCD) and / or an active pixel sensor (CMOS) or any other suitable type of camera sensor. In some embodiments, one or more cameras 204 are configured to capture in vivo image data, for example, in the direction of a longitudinal axis of camera module 200 or base 202 or in a particular direction relative to the longitudinal axis of camera module 200 or base 202 (actively steerable directional camera).

[0079] Exemplary one or more lights 216 In some embodiments, the camera module includes one or more lights 216 mounted on the distal side 314 of the protrusion 306, optionally adjacent to the one or more cameras 204, as shown, for example, in FIG. 2. In some embodiments, the one or more lights may be LEDs.

[0080] Exemplary at least one camera FCB206 Reference is now made to Figures 4a-4f, which illustrate an exemplary camera FCB 206 according to some embodiments of the present invention. In some embodiments, one or more cameras 204 and / or one or more lights 216 are mounted on at least one camera FCB 206. In some embodiments, the arrangement of one or more cameras 204 and / or one or more lights 216 is as shown in Figure 2, and in some embodiments, a different number and / or type and / or arrangement of cameras / lights may be implemented on camera module 200.

[0081] More specifically, reference is made to FIG. 4a, which illustrates a schematic diagram of an exemplary camera FCB 206 in a flat configuration, according to some embodiments of the present invention. In some embodiments, the exemplary camera FCB 206 comprises a distal head configuration 402 that is sized and shaped to match the shape of the base 202 when mounted thereon. In some embodiments, the exemplary camera FCB 206 optionally comprises a neck configuration 404 that is sized and shaped to further match the shape of the base 202 when mounted thereon. In some embodiments, the exemplary camera FCB 206 has an elongated tail 406 connected to the distal head configuration 402 or the neck configuration 404. In some embodiments, the elongated tail 406 is configured to be wrapped (or twisted) around an elongated device, such as an elongated portion of a catheter tube. In some embodiments, when wrapped around an elongate device, the exemplary camera FCB 206 is configured to convey data from one or more cameras 204 and / or other sensors to an appropriate component, such as a processor and / or communications module (not shown), for example, at the proximal end of the elongate device. Optionally, in some embodiments, the exemplary camera FCB 206 may carry at least one additional sensor along its length.

[0082] In FIG. 4a, the exemplary camera FCB 206 is shown in a flat configuration as indicated by a "flat pattern" 408 around the exemplary camera FCB 206 for convenience to illustrate the shape of the exemplary camera FCB 206 when it is first generated.

[0083] In some embodiments, the exemplary camera FCB 206 is configured to be mounted on the base 202 by folding according to the shape of the base 202. Figures 4b-4f schematically illustrate the folding and rolling (or twisting) of the exemplary camera FCB 206. Figure 4b schematically illustrates the folding of the distal head configuration 402 and the partial rolling of the optional neck configuration 404. Figure 4c schematically illustrates the folding of the distal head configuration 402 and the rolling of the neck configuration 404, resulting in the elongated tail 406 being in a rolled (or twisted) position, as shown schematically in Figure 4d.

[0084] In Figure 4e, the rolled up camera FCB 206 is shown adjacent to the base 202, and in Figure 4f, the two are shown mated.

[0085] In some embodiments, the shape of the center of the head matches the shape of the protrusion on the base. In some embodiments, FCB 206 further comprises a small extension in the portion of the head opposite the neck that is designed to fold over the side of the base. In some embodiments, a potential advantage of this extension is that it allows the FCB to be better secured to the base. In some embodiments, another potential advantage of this extension is that it may provide additional area onto which any additional electrical components may be assembled without increasing the size of the bounding circle of the assembled camera module.

[0086] In some embodiments, the neck is positioned so that after the FCB is assembled on the base, it can be wrapped around the body of the base in a flat loop perpendicular to the longitudinal axis of the base. In some embodiments, a potential advantage of such a design is that it allows for the positioning of additional components or the positioning of a starting point for spiral wrapping of the neck at any point around the circumference of the camera module without significantly increasing the length of the camera module. In some embodiments, one possible configuration for such a design can be seen in FIG. 4b. In FIG. 4b, the head is folded at 90 degrees (black arrow), and the neck is slightly offset and aligned with the fold, allowing it to be wrapped around the body of the base.

[0087] In some embodiments, the neck is configured to be long enough to wrap a particular portion of the circumference of the body of the base, for example, 90 degrees, 180 degrees, 270 degrees, 360 degrees, etc. In some embodiments, the neck is designed to wrap 360 degrees around the base. In some embodiments, a potential advantage of such a design is that it allows for the positioning of additional components directly behind the camera module. In some embodiments, such positioning allows for the placement of other components having a size comparable to the camera sensor without increasing the size of the bounding circle of the camera module.

[0088] In some embodiments, the neck is configured to wrap 180 degrees around the base. In some embodiments, a potential advantage of such a design is that the tail wrapping begins on the opposite side of the camera sensor. Thus, if an optional additional sensor is positioned behind the camera and a separate sensor FCB attached to that sensor spirals from that point, the two FCBs will face each other. In some embodiments, a potential advantage of such symmetry is that it creates more uniform mechanical properties, such as stiffness, in different cross-sectional directions.

[0089] Exemplary Optional Distal End Sensor 208 Reference is now made to FIG. 5, which illustrates a schematic diagram of an exemplary optional distal tip sensor 208 according to some embodiments of the present invention. In some embodiments, the exemplary optional distal tip sensor 208 is positioned on the proximal side 312 of the protrusion 306. In some embodiments, the exemplary optional distal tip sensor 208 is a position sensor configured to monitor the position of the distal tip of an elongate interventional device. In some embodiments, it is beneficial to position the sensor as close as possible to the distal tip of the elongate device. For example, if the sensor is an electromagnetic position tracking sensor that monitors the position of the device's tip, it is beneficial to position it as close as possible to the tip. In some embodiments, positioning the sensor 208 directly behind the camera in the camera module allows it to be as close as 1.5 mm to the tip (compared to 3 mm or more for other known devices), for example.

[0090] Exemplary at least one sensor FCB 210 and exemplary one or more optional additional sensors 212 Reference is now made to Figure 6a, which shows a schematic diagram of an exemplary sensor FCB 210 according to some embodiments of the present invention.

[0091] In some embodiments, in addition to the optional distal end sensor 208, the exemplary camera module 200 includes one or more optional additional sensors 212. The optional additional sensors 212 are optionally identical to the optional distal end sensor 208, i.e., position sensors.

[0092] In some embodiments, optional distal tip sensor 208 and / or one or more optional additional sensors 212 are mounted on at least one sensor FCB 210. In some embodiments, sensor FCB 210 includes only elongated FCB 602, such as exemplary camera FCB 206, including only elongated tail 602 and no distal head or neck configuration.

[0093] In some embodiments, similar to that described for the exemplary camera FCB 206, the sensor FCB 210 is wrapped (or twisted) around an elongated device, such as an elongated portion of a catheter tube. In some embodiments, when wrapped around the elongated device, the exemplary sensor FCB 210 is configured to convey data from the optional distal end sensor 208, one or more optional additional sensors 212, and / or other sensors to a suitable component (not shown), such as a processor and / or communications module, at the proximal end of the elongated device.

[0094] In some embodiments, the winding direction of the sensor FCB 210 is the same as the winding direction of the camera FCB 206, as shown in FIG. 6b. FIG. 6b shows the sensor FCB 210 and the camera FCB 206 positioned close together. As can be seen, the two FCBs are wound to complement each other, i.e., the FCBs do not physically overlap. In some embodiments, the FCBs may have a different configuration than that shown in FIG. 6b, such as a different winding direction, a different winding pitch, overlapping FCBs, or one FCB for both the camera and the sensor.

[0095] In some embodiments, sensor FCB 210 is configured to support any distal end sensor 208 on base 202 , for example, back-to-back with one or more cameras 204 .

[0096] Exemplary at least one steering wire 214 Reference is now made to Figures 7a-7c, which illustrate schematic diagrams of an exemplary at least one steering wire 214 for a steering mechanism in an exemplary camera module 200 according to some embodiments of the present invention.

[0097] In some embodiments, the exemplary camera module 200 includes elements necessary to include a steering mechanism for a device user to steer the device, for example, to navigate within a body cavity. These elements may be included in the elongated interventional device or may be provided to the elongated interventional device by the exemplary camera module 200.

[0098] More specifically, reference is now made to FIG. 7a, which illustrates a schematic diagram of an exemplary base 202 having at least one exemplary steering wire 214 according to some embodiments of the present invention. In some embodiments, the exemplary base 202 includes a guide 702, e.g., a groove and / or a protrusion, along the periphery of the exemplary base 202. The steering wire 214 may be inserted into the guide 702 and / or may be connected to and retained by the exemplary base 202. In such embodiments, the steering wire 214 may consist of a single wire that runs from the proximal end of the elongate device to a first side of the exemplary base 202, is guided through the guide 702 to a second side of the exemplary base 202, and returns toward the proximal end of the elongate device, as illustrated generally in FIGS. 7a and 7b. FIG. 7c illustrates the exemplary base 202 and steering wire 214 separated to allow a better view of the exemplary guide 702.

[0099] 7a-7c, the steering wire 214 may be secured to the base 202 in any suitable manner. For example, the base 202 may be or include a metal to form an electrical connection between the two wires 214. For example, the wire 214 may be connected to the base 202 by a mechanical connection, adhesive, welding, soldering, and / or other suitable methods. In some embodiments, the base 202 includes geometric features to support such a mechanical connection, such as, for example, a groove or flat surface to which the steering wire may be bonded.

[0100] In some embodiments, the camera module includes three, four, or more wires that allow the elongated device to be steered in any direction in a plane perpendicular to the device's longitudinal axis, as shown, for example, schematically in FIG. 7d. In some embodiments, the base is connected to four steering wires, optionally evenly spaced. In some embodiments, pulling one wire deflects the camera module in the direction of that wire, and pulling two wires deflects the camera module in a direction between the positions of the two wires, depending on the amount of tension on each wire. In some embodiments, the wires are optionally evenly spaced. In some embodiments, the wires are spread around the periphery with uneven spacing. In some embodiments, such uneven spacing leaves a larger gap between the two steering wires. In some embodiments, a potential advantage of such a larger gap is that it allows other components to be positioned between the two wires. In this case, the larger gap compared to even spacing can be a greater advantage.

[0101] In some embodiments, a potential advantage of connecting the steering mechanism and / or steering wires 214 directly to the base 202 is that it may provide a relatively short distal end for the elongated interventional device, e.g., as short as 3 mm or less, as opposed to 7 mm or more for some available devices. In some embodiments, the relatively short distal end may improve the steerability and / or maneuverability of the elongated device. In some embodiments, furthermore, closely mechanically connecting the steering wires 214 to one or more cameras 204 may improve the precision and sensitivity of camera orientation adjustments. In some embodiments, furthermore, having the steering wires 214 directly connected to the base 202 and / or to the camera module 200 may provide mechanical strength and stability to the overall structure and / or to the installation of the camera module 200.

[0102] Exemplary Mold 218 Reference is now made to FIG. 8, which shows a schematic diagram of an exemplary mold 218 optionally used in a camera module 200 according to some embodiments of the present invention. In some embodiments, the exemplary camera module 200 comprises a mold 200 fabricated on a base 202, including the components described above. In some embodiments, the mold 218 secures the base 202 and the supported components in a protective and precisely aligned manner, potentially preventing relative movement of the components. In some embodiments, the mold 218 provides electrical insulation for the components. In some embodiments, when the steering wires are not mechanically secured to the base, for example, when a single wire is threaded over the guide and then returns to the proximal side of the elongate device, as shown in FIGS. 7a-7c, the mold secures the wire to the camera module, preventing it from sliding or being pulled to either side when the wire is pulled.

[0103] Exemplary Methods Reference is now made to Figure 9, which shows a flowchart of an exemplary camera module assembly method according to some embodiments of the present invention. In some embodiments, the assembly method includes the following operations. 1. One or more steering wires are connected to the base (902) 2. Attach the head of the camera FCB to the distal side of the convex part (904). 3. Optionally, fold the FCB extension over the edge of the convex portion and secure it in place (906). 4. Fold the head of the FCB over the other edge of the convex part and wrap the neck around the body of the base (908). 5. Fix the sensor mounted on the sensor FCB to the base body directly behind the protrusion aligned with the camera sensor (910). 6. Position the assembly in a molding tool and pour resin to form a mold around the camera module (912).

[0104] It is to be understood that the above methods are exemplary methods and that such methods may include additional and / or different operations and / or different combinations.

[0105] When referring to an amount or value herein, the term "about" means "within ±10% of."

[0106] The terms "comprises," "comprising," "includes," "including," "has," "having," and their cognates mean "including but not limited to."

[0107] The term "consisting of" means "including and limited to."

[0108] The term "consisting essentially of" means that a composition, method, or structure may include additional ingredients, steps, and / or moieties, but only if the additional ingredients, steps, and / or moieties do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0109] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly indicates otherwise. For example, the terms "a compound" or "at least one compound" may include multiple compounds, including mixtures thereof.

[0110] Throughout this application, embodiments of the present invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all possible subranges and individual numerical values ​​within that range. For example, a description of a range such as "1 to 6" should be considered to have specifically disclosed individual numerical values ​​within that range, such as 1, 2, 3, 4, 5, and 6, as well as subranges such as "1 to 3," "1 to 4," "1 to 5," "2 to 4," "2 to 6," and "3 to 6." This is true regardless of the width of the range.

[0111] When a range of numerical values ​​is given herein (e.g., "10 to 15 (10-15)," "10 to 15 (10 to 15)," or any pair of numbers connected by these other range designators), it is meant to include any number (fractional or integer) within the bounds of the stated range, inclusive of the bounds of the range, unless the context clearly indicates otherwise. As used herein, the phrase "range / ranging / ranges between" a first recited number and a second recited number, and the phrase "range / ranging / ranges" of "from" a first recited number and "to," "up to," "until," or "through" a second recited number (or other such range-indicating term), are used interchangeably and are meant to include the first recited number, the second recited number, and all fractional and integer numbers therebetween.

[0112] Unless otherwise indicated, numbers used herein, and any numerical ranges based thereon, are approximations within the accuracy of reasonable measurement and rounding errors, as will be understood by one of ordinary skill in the art.

[0113] It is understood that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination, or as appropriate, in any other described embodiment of the invention. Particular features described in the context of various embodiments should not be considered essential features of those embodiments, except to the extent that the embodiment cannot function without those elements.

[0114] While the present invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

[0115] It is the intention of the applicant(s) that all publications, patents, and patent applications mentioned herein be incorporated by reference in their entirety, as if each individual publication, patent, and patent application was specifically and individually indicated to be incorporated by reference herein. In addition, citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. Section headings, if used, should not be construed as necessarily limiting. In addition, the priority document(s) of this application are incorporated by reference herein in their entirety.

Claims

1. 1. A camera module for mounting on an elongated interventional device, comprising: a. a base having a body; b. at least one camera FCB (flexible printed circuit board) attached to the base; c. one or more cameras positioned on said at least one camera FCB and on said body; A camera module comprising:

2. further comprising at least one protrusion positioned on the body of the base; The camera module of claim 1 .

3. the one or more cameras are positioned on the at least one protrusion; The camera module according to claim 2 .

4. the base further comprising at least one channel sized and shaped to match a working channel of the elongate interventional device; The camera module of claim 1 .

5. The at least one protrusion includes a distal surface and a proximal surface. The camera module of claim 1 .

6. the one or more cameras are positioned on the distal surface of the convex portion; The camera module according to claim 5 .

7. further comprising at least one first sensor and at least one sensor flexible printed circuit board (sensor FCB); The camera module of claim 1 .

8. the at least one first sensor is mounted on the sensor FCB; The camera module according to claim 7 .

9. the at least one first sensor is positioned on the proximal surface of the protrusion; The camera module according to claim 7 .

10. further comprising at least one second sensor positioned on the sensor FCB; The camera module according to claim 7 .

11. and further comprising at least one second sensor positioned on said camera FCB. The camera module of claim 1 .

12. The camera FCB is a. a distal head arrangement; b. a neck configuration attached to the distal head configuration; c. an elongated tail attached to the neck structure; comprising one or more of: The camera module of claim 1 .

13. the distal head configuration and the neck configuration both have a shape that matches the shape of the base; The camera module of claim 12.

14. the elongate tail is wound along a longitudinal axis of the base, the longitudinal axis of the base being coincident with a longitudinal axis of the elongate interventional device; The camera module of claim 12.

15. the neck arrangement is configured to wrap around the base in a plane perpendicular to a longitudinal axis of the base; The camera module of claim 12.

16. The winding of the elongated tail is clockwise or counterclockwise. The camera module of claim 14.

17. the sensor FCB is wound along a longitudinal axis of the base, the longitudinal axis of the base being coincident with a longitudinal axis of the elongated interventional device; The camera module of claim 10.

18. the elongate tail and the sensor FCB are both wound along a longitudinal axis of the base that coincides with a longitudinal axis of the elongate interventional device; 18. The camera module of claim 17.

19. the windings of the elongated tail and the windings of the sensor FCB have the same winding direction; 18. The camera module of claim 17.

20. the turns of the elongate tail and the turns of the sensor FCB do not overlap; 18. The camera module of claim 17.

21. the winding of the elongate tail and the winding of the sensor FCB have different winding orientations; 18. The camera module of claim 17.

22. the turns of the elongated tail and the turns of the sensor FCB overlap; 18. The camera module of claim 17.

23. further comprising one or more lights positioned on the base. The camera module of claim 1 .

24. the one or more lights are mounted on the distal surface of the protrusion; 24. The camera module of claim 23.

25. the one or more lights are mounted adjacent to the one or more cameras; 24. The camera module of claim 23.

26. the one or more lights are mounted on the camera FCB; 24. The camera module of claim 23.

27. the base further comprises at least one connection element for at least one steering mechanism; The camera module of claim 1 .

28. the at least one steering mechanism is at least one steering wire; 28. The camera module of claim 27.

29. the at least one connecting element is one or more of a slit, a protrusion, and an anchor; 28. The camera module of claim 27.

30. further comprising a mold surrounding the distal end of the camera module. The camera module of claim 1 .

31. the mold is configured to hold a plurality of components to the base of the camera module.

31. The camera module of claim 30.

32. 1. A camera module for installation on an elongated interventional device configured to be inserted into and navigated within a body cavity, the camera module comprising: a. a fixture having a body configured to connect to a steering wire of the elongate device and a protrusion; b. a flexible PCB having a face plate, a face fold mark, a start-of-wind fold mark, and a PCB wrappable tail, the face plate including a camera and lighting components, the flexible PCB being foldable tightly around the fixture and around the elongate device; c. a mold that holds the fixture and the flexible PCB together; A camera module comprising:

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