Medical imaging device with electrical noise reduction

Abstract

An invasive medical device and a visualization system including the same. The invasive medical device includes a proximal end and a distal end spaced apart from the proximal end; a camera and a light source positioned at the distal end; and a cable harness including a first coaxial cable and a second coaxial cable within a common shield, the cable harness extending from a proximal end to a distal end and the distal end being electrically connected to the camera and the light source, where the common shield electrically connects the ground to the camera and the light source.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to invasive medical devices, such as endoscopes and respiratory tubes, that include a distal camera, and in particular to invasive medical devices configured to mitigate electrical noise. BACKGROUND

[0002] Visualization systems that include video processing apparatus electrically connected to an invasive medical device are known and can be used for visually navigating into hollow organs and body cavities and for inspection and diagnosis, and optionally for assisting in surgical procedures, e.g., for targeted tissue sampling. Example invasive medical devices include endoscopes and respiratory tubes. Endoscopes include procedure-specific endoscopes such as bronchoscopes, arthroscopes, cystoscopes, ureteroscopes, cholangioscopes, colonoscopes, laparoscopes, gastroscopes, and duodenoscopes. Respiratory tubes include bronchial tubes, tracheal tubes, tracheostomy tubes, and other tubes configured to ventilate at least a portion of a patient’s respiratory system or lungs, and can include laryngeal masks or inflatable cuff. A visualization system that includes an endoscope operable with surgical tools is described in commonly-owned U.S. Patent No. 10,646,107. Respiratory tubes are described in commonly-owned U.S. Patent Nos. 9,486,595, 9,889,264, 10,406,309, and 10,888,679. A visualization system that includes a portable medical monitor having a display screen is described in commonly-owned U.S. Patent Nos. 11,266,297 and 11,328,390.

[0003] Electrosurgical instruments can be guided through the lumen of an invasive medical device to perform a medical procedure within a patient’s body cavity. Known electrosurgical tools operated by high-voltage pulses (e.g., in the range of 2 kV to 8 kV) can produce high-frequency noise in the signal and interference in the video that is noticeable to the user during a procedure. Electrosurgical tools configured to perform argon plasma coagulation (APC) are an example of such electrosurgical tools. Argon plasma coagulation is an electrosurgical monopolar procedure that uses ionized argon gas, which is an inert gas that is easily ionized, for surface hemostasis, inactivation, and ablation. The high-voltage pulses create a strong electric field (high frequency) that can manifest as high-frequency noise on the electrical leads. Electrical noise in the video signal can also be caused by the high-frequency clock signal (which can be, for example, 4 MHz, 12 MHz, or 24 MHz, depending on the particular image sensor). This electrical noise is sometimes referred to as “hum” or “crossed clock.”

[0004] Electrical noise can cause image quality degradation or loss of real-time images for various reasons, including camera module “freezing” (requiring a reset) and errors in communication of control data to the camera, i.e., data is written to the wrong location, or the wrong data is written in the camera’s registers.

[0005] In addition, known invasive medical devices can have a diameter greater than 3.4 mm and can have sufficient space to not impose size or configuration limitations on the electrical leads. However, as the size of the invasive medical device decreases, particularly when the distal end diameter is 3.4 mm or less, which is desirable to mitigate tissue damage and facilitate navigation into the patient, it is desirable to reduce the size or configuration of the electrical leads.

[0006] Still further, it is desirable to present images in real-time on a display screen. Known medical monitors can employ image processing algorithms configured to mitigate the effects of electrical noise. For example, a medical monitor can average frames (e.g., a series of frames or images) of a video stream, or exclude frames from a video stream that are defective (e.g., show vertical or horizontal lines, show large areas of over or under exposure, or are defective for other reasons). This can result in a physician seeing outdated frames, even if only for a fraction of a second, which is undesirable. If the image processing algorithms are modified to present the video stream in real-time or closer to real-time, these video stream noise mitigation techniques are no longer available, and the electrical noise in the invasive medical device must be reduced or eliminated to ensure a sufficient user experience.

[0007] Additionally, the image processing algorithms can be modified to add features such as navigation and tissue / object recognition that can require larger, more expensive hardware if added without deleting code. Thus, the overall cost can be reduced by removing the noise mitigation processing instructions through improvements to the invasive medical device.

[0008] Disposable invasive medical devices optimize workflow and reduce costs while saving patient lives and improving patient care. Disposable invasive medical devices optimize workflow and reduce costs in that they are available when needed without the traditional high capital and maintenance budget required for reusable invasive medical devices. For example, sterilization and storage facilities are avoided, there is no need to keep sterilization evidence, and there is no need to transport invasive medical devices from sterilization and storage facilities to the place where the invasive medical devices are needed, sometimes in the middle of the night or on weekends. Disposable invasive medical devices save patient lives and improve patient care in that they are readily available and do not pose a risk of cross-contamination. This also reduces readmissions. While disposable invasive medical devices are disposed of after a single use by a patient (a patient can perform one or more surgeries in a treatment room), for reusable invasive medical devices, the environmental impact of reusable invasive medical devices can be similar to that of disposable invasive medical devices due to material cleaning, CO2 emissions during cleaning, and the use of disposable personal protective equipment by personnel involved in the transportation and sterilization of reusable invasive medical devices. To further reduce the environmental impact, the invasive medical devices according to the present disclosure are made primarily of polymeric materials.

[0009] For at least the reasons mentioned above, it is desirable to incorporate noise- reducing features into invasive medical devices, in particular disposable medical devices, to increase their value, in particular to increase their effectiveness when used with tools that generate electronic noise.

[0010] To further enhance the benefits of disposable invasive medical devices, it is desirable to extend the applicability of invasive medical devices, for example by enabling even smaller devices.

[0011] To further increase the benefits of disposable invasive medical devices, it is desirable to reduce manufacturing costs. SUMMARY

[0012] It is an object of the present disclosure to provide an invasive medical device having features that eliminate or at least reduce the disadvantages of the prior art invasive medical devices and to suitably address the problems mentioned above. In particular, it is an object of the present disclosure to propose an invasive medical device that exhibits reduced electrical noise interference compared to the prior art invasive medical devices.

[0013] The first aspect relates to extending the applicability of the invasive medical device as claimed in claim 1 and the visualization system as claimed in claim 12. Advantageous embodiments are claimed in the dependent claims and / or explained hereinafter. The invasive medical device as claimed in claim 1 is advantageous in that electrical noise is effectively reduced. Furthermore, as will be explained in detail hereinafter, the use of a coaxial cable contributes to a compact construction.

[0014] In a variation of the embodiment of claim 1, the coaxial cable is untwisted. A potential advantage of twisted-pair coaxial cables (where two coaxial cables are twisted together) is improved reduction of electrical noise. However, arranging untwisted coaxial cables side-by-side allows the cable bundle to have a very small profile, which is advantageous because, during assembly, this narrow radial profile allows for an overall reduction in the diameter of the insert or the distal end of the insert.

[0015] In another variation of this embodiment, a first cable shield is electrically connected to a light source and configured to supply power; a first cable center conductor is electrically connected to a camera and configured to transmit video signals; a second cable shield is electrically connected to the camera and configured to supply power; and the second cable center conductor is electrically connected to the camera and configured to transmit clock signals. In other words, the first cable shield supplies power to the light source; the first cable center conductor transmits video signals from the camera; the second cable shield supplies power to the camera; and the second cable center conductor transmits clock signals to the camera. This configuration separates the light source power conductor from the clock signal conductor, which can help reduce potential electrical noise from the light source power conductor to the clock signal. The first cable shield, the first cable center conductor, the second cable shield, and the second cable center conductor can be directly or indirectly connected to the light source and the camera. The light source power conductor can be independent of the camera power conductor.

[0016] In another variation of this embodiment, a first cable shield is electrically connected to the light source and configured to supply power; a first cable center conductor is electrically connected to the camera and configured to transmit a clock signal; a second cable shield is electrically connected to the camera and configured to supply power; and a second cable center conductor is electrically connected to the camera and configured to transmit a video signal. This configuration separates the light source power conductor from the video signal conductor, which can help reduce potential electrical noise from the light source power conductor to the video signal.

[0017] In the example of the embodiment, the coaxial cable has a center conductor cross-sectional area of ​​0.0005 mm². 2 Up to 0.0055mm 2 Within the range, for example, in 0.0008mm 2 up to 0.0035mm 2 Within the range, for example, 0.0014mm 2 Miniature coaxial cables. These cross-sectional areas of the center conductor have been found suitable for invasive medical devices. Greater than 0.0055 mm². 2 The advantage of a smaller cross-sectional area is that the conductor is durable and has relatively low resistance, but it is not currently the preferred choice due to the increased size of the cable bundle. Below 0.0005 mm²2 The advantage of a large cross-sectional area is that it facilitates a very compact construction, but the increased resistance, physical fragility, and generally higher cost make it a less preferred choice.

[0018] In the example of this embodiment, the height of the cable bundle is in the range of 0.1 mm to 0.7 mm, for example, in the range of 0.2 mm to 0.6 mm, such as 0.35 mm. A cable bundle height below 0.7 mm has been found advantageous for invasive medical devices because it allows for a very compact construction of invasive medical devices with minimal external dimensions and / or invasive medical devices with large working channels. Therefore, a low cable bundle height is relevant for both small invasive medical devices (e.g., bronchoscopes for pediatric indications) and larger gastroscopes, as the cable bundle does not occupy much space. In most cases, a cable bundle height in the range of 0.2 mm to 0.6 mm has been found to be a suitable trade-off between compactness, cost, and electrical noise reduction.

[0019] In the example of this embodiment, the cable bundle width is in the range of 0.2 mm to 0.9 mm, for example, in the range of 0.4 mm to 0.75 mm, such as 0.60 mm. In some invasive medical devices (such as colonoscopes), a width greater than 0.9 mm may be acceptable, but for most invasive medical devices, a cable bundle width in the range of 0.4 mm to 0.75 mm is found to provide a suitable trade-off between compactness, cost, and electrical noise reduction.

[0020] In this example, the height-to-width ratio of the cable bundle is in the range of 0.55 to 0.75, for example, 0.67.

[0021] Embodiments of this disclosure relate to an invasive medical device, wherein the invasive medical device includes an endoscope comprising: a proximal end including a positioning interface having a distal end; an insertion cable connected to and extending from the distal end of the positioning interface, and including an insertion tube, a bent portion, and an end housing, wherein a camera is positioned within the end housing, and a tubular member extends from the positioning interface through the insertion tube to the end housing, wherein a wire harness extends from the positioning interface to the end housing.

[0022] In this example embodiment, the curved portion includes a diameter in the range of 1.8 mm to 6.0 mm, for example, in the range of 2.0 mm to 3 mm, for example, 2.5 mm. The diameter of the curved portion is the maximum diameter of the curved portion, without any potential curved cap. For example, for bronchoscopes and nasopharyngoscopes, the diameter of the curved portion within the specified range is considered a suitable compromise.

[0023] In this example embodiment, the ratio of cable bundle height to the diameter of the bend is less than 0.2, for example, in the range of 0.04 to 0.16, such as approximately 0.1. For some embodiments, such as invasive medical devices without a working channel, a ratio higher than 0.2 may be acceptable. However, a ratio lower than 0.2 is considered advantageous because the cable bundle thus occupies a relatively small percentage of the cross-section of the bend, and a ratio in the range of 0.04 to 0.16 is considered a suitable compromise in practice.

[0024] One aspect of this disclosure relates to a visualization system comprising: an invasive medical device as disclosed above; and a video processing apparatus configured to communicatively connect to the invasive medical device to receive a video stream from the invasive medical device.

[0025] One or more objectives can be achieved through the aspects described in the following embodiments, variations and examples of the present invention.

[0026] Those skilled in the art will understand that any one or more of the above aspects of this disclosure and their embodiments can be combined with any one or more of the other aspects of this disclosure and their embodiments. Attached Figure Description

[0027] The embodiments of this disclosure will now be described in more detail with reference to the accompanying drawings. The drawings illustrate embodiments, variations, and examples to aid understanding by those skilled in the art and should not be construed as limiting the scope of the appended claims.

[0028] Figure 1 and Figure 2 This is a schematic diagram based on a detailed description of an invasive medical device;

[0029] Figure 3 This is a schematic diagram of an electrosurgical system and a visualization system including invasive medical devices;

[0030] Figure 4 This is a perspective view of an embodiment of an invasive medical device illustrated using an endoscope as an example.

[0031] Figure 5 yes Figure 4 A three-dimensional view of the distal portion of the end mirror, with the covering removed for illustrative purposes;

[0032] Figures 6 to 10 It includes Figure 4 and Figure 5 A cross-sectional view of an embodiment of the curved portion of an endoscope, including the depicted endoscope.

[0033] Figure 11 andFigure 12 This is a plan view and a cross-sectional view of another embodiment of an invasive medical device illustrated using a double-lumen tube as an example;

[0034] Figure 13 and Figure 14 Is it possible to... Figures 1 to 12 Perspective and plan views of an embodiment of a video processing device that operates together with an invasive medical device;

[0035] Figure 15 This is a schematic cross-sectional view of a biaxial cable.

[0036] Figure 16 yes Figure 15 The twin coaxial cable is combined in Figure 2 The diagram in the illustration, and

[0037] Figure 17 yes Figure 15 Alternative wiring for biaxial cables is incorporated into Figure 2 The diagram is shown in the figure. Detailed Implementation

[0038] As used in this article, the term "far side" refers to the direction or location generally toward the target site, and the term "proximal side" refers to the direction or location generally away from the target site.

[0039] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In case of any conflict, this document (including the definitions) shall prevail. Preferred methods and materials are shown below, although similar or equivalent apparatus, methods, and materials may be used in practice or testing. The materials, methods, and examples disclosed herein are illustrative only and not intended to be limiting.

[0040] As described herein, an invasive medical device may include: a proximal end and a distal end spaced apart from the proximal end; a tubular member defining a lumen within the tubular member extending from the proximal end to the distal end; a camera and at least one light source positioned at the distal end; and a cable bundle comprising a first coaxial cable and a second coaxial cable within a common electrical shield, the cable bundle extending from the proximal end to the distal end and electrically connected at the distal end to the camera and the light source; the first coaxial cable including a first cable center conductor, a first cable insulation layer, and a first cable shield; the second coaxial cable including a second cable center conductor, a second cable insulation layer, and a second cable shield; one of the first cable shield or the second cable shield being electrically connected to the light source and configured to supply power; the other of the first cable shield or the second cable shield being electrically connected to the camera and configured to supply power to the camera; one of the first cable center conductor or the second cable center conductor being electrically connected to the camera and configured to transmit a video signal; the other of the first cable center conductor or the second cable center conductor being electrically connected to the camera and configured to transmit a clock signal; and the common electrical shield grounding the camera and the light source. The invasive medical device may include an endoscope.

[0041] Advantageously, the invasive medical devices described above, whether or not they have internally defined tubular components, reduce electrical noise. Electrical noise can be crosstalk and / or generated by electrosurgical instruments (ESTs) or other electromagnetic fields. Electrical noise can also be emitted by the invasive medical device itself, which can cause problems and fail to comply with electromagnetic compatibility (EMC) regulations. Video signal cables can transmit digital or analog video data. In addition to video signals, video signal cables can also transmit control signals.

[0042] A wire harness consisting of two coaxial cables can be encapsulated in an electrical shield. The electrical shield can disconnect the electrical connection at the far end of the wire harness. The wire harness has a near end. The electrical shield can only be grounded at the near end of the wire harness.

[0043] Invasive medical devices have been described in general terms; now we will focus on a more detailed description of implementation methods for said invasive medical devices.

[0044] Figure 1 and Figure 2 This is a schematic diagram of an implementation of a visualization system 20, which includes a video processing unit 30 electrically connected to an invasive medical device 40 via a cable 42 and a cable connector 44. Examples of the invasive medical device 40 include an endoscope (see reference). Figures 4 to 10 The aforementioned), double-lumen tube (reference) Figure 11 and Figure 12The above-described device, as well as any other device configured for insertion into a patient, human, or animal and containing a light source at its distal end, are also shown. An electrosurgical instrument (EST) for use with the visualization system 20 is also shown. Figure 1 and Figure 2 The illustrated invasive medical device 40 showcases some features and components that can be optionally configured. Embodiments of the light source include light-emitting diodes (LEDs or OLEDs) and laser diodes. Laser diodes can be advantageous in some conditions because they can emit more light than LEDs or OLEDs. This can be used to provide the same light intensity from a smaller footprint, or to provide more light, which can positively impact image quality. On the other hand, laser diodes emit both codirectional and unidirectional light, which can be a disadvantage in some cases. Currently, LEDs are preferred.

[0045] like Figure 2 As shown and described in further detail below, the video processing apparatus 30 includes a cable connector receiver 32, input circuitry 34, and a processor 36. Optionally, the VPA 30 may include a housing supporting a display screen connected to and operable to display images provided by the processor 36. (Reference) Figure 13 Describe a VPA with a display screen. Reference Figure 3 and Figure 14 This describes a VPA without a display screen. Input circuitry 34 may include deserializer circuitry for converting data or signals provided by the image sensor of a camera from a serial format to a parallel format. Processor 36 may include an FPGA, CPU, GPU, or a combination thereof. The FPGA can be programmed for video processing to improve the image, and the CPU can be configured to configure a graphical user interface (GUI) and overlay the GUI onto the image. The combined content can be provided to the FPGA, which can be connected to video output circuitry.

[0046] The invasive medical device 40 has a proximal end 40p and a distal end 40d spaced apart from the proximal end 40p, and includes a cable 42 and a cable connector 44, an optional positioning interface 46, an optional circuit board 48, and a tubular member 50 having a proximal end 50p, a distal end 50d, and a tubular member wall 52 defining an inner lumen 54 configured to receive an EST passing through it. The tubular member 50 extends from the proximal end 40p to the distal end 40d.

[0047] The invasive medical device 40 also includes a camera 60, an optional circuit board 62, a light-emitting diode (LED) 64, a cable bundle 70 having wires 72 and an electrical shield 74, and a proximal shield ground 76 (e.g., the connection between the electrical shield 74 and the ground). The camera may include an image sensor, a lens, and a lens holder coupled to the image sensor. The cross-section of the image sensor may be less than 2.0 mm per side, preferably less than 1.9 mm per side. The cable bundle 70 extends from the distal end 50d to at least the proximal end 50p. The wiring harness 70 consists of a first coaxial cable and a second coaxial cable within a common electrical shield 74. The cable harness extends from a near end to a far end, with the far end electrically connected to a camera and a light source. The first coaxial cable includes a first cable center conductor, a first cable insulation layer, and a first cable shield. The second coaxial cable includes a second cable center conductor, a second cable insulation layer, and a second cable shield. One of the first or second cable shields is electrically connected to the light source and configured to supply power. The other of the first or second cable shields is electrically connected to the camera and configured to supply power. One of the first or second cable center conductors is electrically connected to the camera and configured to transmit a video signal. The other of the first or second cable center conductors is electrically connected to the camera and configured to transmit a clock signal. The common electrical shield connects the camera and the light source to the ground.

[0048] For reference Figure 1 and Figure 2 The invasive medical device may include a tubular member defining a lumen extending from a proximal end to a distal end. However, invasive medical devices may not have such a lumen. For example, some endoscopes are used for examination and can be introduced into a patient through the lumen of another invasive medical device having one or more lumens. The advantages of the electrical noise reduction features described herein also apply to such endoscopes because different tools and systems can be used for electrosurgery. In some systems, the EST is introduced through the lumen of the invasive medical device 40. In some systems, the EST is not introduced through the lumen of the invasive medical device 40.

[0049] Figure 3 An example of an electrosurgical system 80 is shown, comprising two electrodes 82 and 84 that form an electrical pathway 86 through the patient's body. An EST (e.g., electrode 82) can be introduced into the patient's body through the lumen of a tubular member (not shown). A separate wiring harness 70 connected to a camera 60 and a cable 42 is shown to illustrate that the wiring harness 70 is not necessarily part of an invasive medical device having a tubular member through which the EST is introduced into the patient's body. Cable 42 is shown with reference to... Figure 14The described VPA 260 connection includes a detachable display screen 90 and a display screen bracket 92 configured to be detachable from both the VPA 260 and the display screen 90 during normal use. The display screen is operable to display images and video streams generated and transmitted by a camera 60. A VPA 240 (described below) can be used instead of the VPA 260.

[0050] Figure 4 and Figure 5 An embodiment of an invasive medical device 40, illustrated using an endoscope 140 as an example, is shown. The endoscope includes a positioning interface, exemplified by a handle 146, which includes a steering controller 148, operable, as is known in the art, for alternating pulling in response to movement of the steering controller 148. Figure 5 The shown steering wire 174 is used to steer the distal end of the endoscope 140. The endoscope 140 includes an insertion cable 150 having a proximal end 150p and a distal end 150d, the insertion cable 150 including an insertion tube 152 and a bend 160. A distal end including an end housing 170 extends from the bend 160. A camera 60 is positioned within the end housing 170. Alternatively, the camera 60 may be at least partially positioned within the end housing 170. The bend 160 may include a monolithic polymer structure comprising a plurality of segments 166 located between the proximal segment 162 and the distal segment 164 connected to the end housing 170. These segments are interconnected by a polymer band 168 or hinges that form part of the monolithic structure and bend when the steering wire 174 is tensioned. The working channel tube 172 is an example of a tubular member 50 providing a lumen 54 for introducing the EST.

[0051] The curved portion can also be assembled from multiple pieces instead of a single polymer structure. Such an assembly can be formed from two single polymer structures that elongate to form two opposing longitudinal halves of the final curved portion. Alternatively, the assembly can be formed from individual segments assembled via hinges.

[0052] Endoscope 140 can be a single-use device. Single-use devices are designed to be low-cost and disposable, and are not cleaned or disinfected after use, and are not reused after cleaning.

[0053] A positioning interface is used to control the position of the inserted wire. A handle is an example of a positioning interface, and these terms are used interchangeably unless otherwise specified. A handle also serves to provide a steering controller (e.g., a knob, lever, button, etc.) to steer the camera's field of view. Alternatively, a different positioning interface may be provided that is connected to the inserted wire and detachably connected to a robotic arm. Thus, the inserted wire extends from the robotic arm, and the invasive medical device can be detached from the robotic arm. The robotic arm responds to signals (including voice commands from the operator) to rotate, translate, or otherwise position the proximal end of the inserted wire, as if done manually by the operator. The positioning interface may include control actuators, including manually operated control actuators. Alternatively or additionally, control actuators may be located within or on the robotic arm, or via a robotic system including the robotic arm, potentially reducing the cost of the invasive medical device. Example control actuators include single-axis actuators, including linear motion actuators. A linear motion actuator may include a threaded rod connected to a threaded nut portion, in which a motor rotates the rod to translate the nut portion.

[0054] Figure 6 This is a schematic diagram of the cross-section AA of the bent portion 160, showing a section of one segment, including the working channel tube 172, the inner cavity 54 or working channel inner cavity, the steering wire 174, the steering wire guide tube 176, and the cable bundle 70. The bent portion 160 has an outer diameter D. The steering wire guide tube 176 surrounds the steering wires 174, one end of which is connected to the end housing 170 and the opposite end to the steering controller 148. The wall of segment 166 ( Figure 6 (Not shown) Includes cutouts or openings through which the steering cable guide tube 176 passes and cutouts or openings for the cable bundle 70. Reference Figures 7 to 9 An example of an opening or aperture is shown and described. The cable bundle 70 shown is non-circular, having a flat or rectangular cross-section with a height h and a width w. This is advantageous because the cable bundle 70 can be arranged in the radial direction of the cross-section to have the shortest dimension (i.e., height), thereby the cable bundle 70 will occupy a minimum percentage of the outer diameter D of the curved portion, making it possible to provide a small outer diameter D or a large inner diameter d for the cavity 54, both of which are desirable.

[0055] A sleeve or bend cap (not shown) may be provided on the bend segment 160 to fluid-seal the space between adjacent segments 166. The outer diameter of segment 166 may be substantially similar to or the same as the outer diameter of end housing 170. In some embodiments, the outer diameter is less than 4.2 mm, less than 3.6 mm, less than 3.4 mm, less than 3.2 mm, and even less than 3.0 mm, wherein the minimum outer diameter is 1.8 mm.

[0056] In variant A of this embodiment, the wall thickness of the working channel tube is between 0.10 mm and 0.20 mm and includes the end value, preferably between 0.12 mm and 0.18 mm and includes the end value, more preferably about 0.15 mm, and the outer diameter of the working channel tube is between 2.0 mm and 3.0 mm and includes the end value, preferably between 2.20 mm and 2.80 mm and includes the end value, more preferably between 2.40 mm and 2.60 mm and includes the end value.

[0057] In variant B of this embodiment, the minimum dimension of the cable bundle 70 is between 0.40 mm and 0.56 mm and includes the end value, preferably between 0.44 mm and 0.52 mm and includes the end value, more preferably between 0.45 mm and 0.50 mm and includes the end value, and the outer diameter of the working channel tube is between 2.0 mm and 3.0 mm and includes the end value, preferably between 2.20 mm and 2.80 mm and includes the end value, and more preferably between 2.40 mm and 2.60 mm and includes the end value.

[0058] In variant C of this embodiment, the inner diameter of the insertion tube is less than 3.8 mm, or less than 3.4 mm, or less than 3.0 mm.

[0059] The various variations of this implementation scheme can be combined to form additional variations of the implementation scheme. Therefore, variation A can be combined with variation B to form a new variation, variation A can be combined with variation C to form a new variation, variation A can be combined with variation B and variation C to form a new variation, and variation B can be combined with variation C to form a new variation.

[0060] Figures 7 to 10 Examples of segmental walls are provided, which are configured to keep the steering wire 174 separate and secure the harness 70 in the bend 160. For example, Figure 7 A common opening 180 is shown, which defines a working channel tube opening 182, a steering wire opening 184 (an opening from the periphery of the working channel tube opening 182), and a wiring harness opening 186. Providing openings around the working channel tube opening 182 reduces the diameter of the bend 160 and increases its flexibility. Figure 8 Another example of an opening 180 in a curved portion 190 is shown. (See example...) Figure 7 As shown, the opening 180 in this example includes three openings for the redirection of the wire 174 and the wire harness 70. Since the cross-sectional area of ​​the opening 186 is relatively large compared to the cross-section of the wire harness 70, additional conduits can be installed in this opening. Figure 9 An example of a common opening 180' in the curved portion 192 is shown. Figure 7As shown, the opening 180' in this example includes an opening for the wire harness 70 and possibly for other conduits or components, and an opening 176' for turning the wire 174. Since the cross-sectional area of ​​the opening 186 is larger than that of the wire harness 70, additional conduits can be placed in this opening. Figure 10 An example of a common opening 180 in bend 194 is shown. Bend 194 differs from bend 192 in that it provides an opening instead of a perforation for the steering wire 174. As used herein, a common opening refers to an opening that accommodates the working channel conduit and one or more steering wires and harnesses. As shown, the perforation provides accommodation for the steering wires and harnesses. Where size permits, openings for the working channel conduit, steering wires, and harnesses can also be provided via separate openings instead of a common opening.

[0061] The cross-section of camera 60 may be less than 2.0 mm on each side. The outer diameter of end housing 170 may be about 3.0 mm, preferably about 2.8 mm, more preferably less than 2.8 mm. The term "about" is intended to define a range of a specified number + / - 10%.

[0062] For the benefit of patients, as the size of cameras and curved sections continues to decrease, the cross-sectional percentage of wires and cables is also increasing. It is valuable to continue reducing size and cost, identifying cable configurations (cables include wires, shielding, sheathing, etc.), and using smaller wires while still avoiding the negative impact of electrical noise. The success of mitigation measures depends on the image sensor and deserializer used, the length of the harness, and the structure surrounding the harness.

[0063] Figure 11 and Figure 12 Another embodiment of the invasive medical device 40, exemplified by the dual-lumen tube 200, is shown. Figure 12 A cross-section BB of tube 200 is shown. The dual-lumen tube 200 includes a tubular member 200a having an outer peripheral (or circumferential) wall 201 defining a first inner cavity 202 and an illumination inner cavity 208 within the outer peripheral wall. A camera 60 and an LED 206 are positioned within the illumination inner cavity 208 located in the wall of tube 200.

[0064] For example, the double-lumen tube can be a bronchial tube or a tracheal tube. The double-lumen tube 200 may also have a second lumen 204. The outer peripheral wall 201 may consist of a first portion 210 and a second portion 212 separated by an intermediate wall 214. An inflatable cuff 220 is disposed at the distal end and connected to an inflation tube 222 via an inflation lumen (not shown), which can be connected to a pump to inflate the cuff 220. Similar to the endoscope 140, it is desirable to reduce the size of the device and increase its flexibility, for example by reducing the wall thickness of the tube, which requires reducing the size of the camera 60 and the wiring harness 70. Although not shown, the wiring harness 70 is positioned in the illumination lumen 208 and communicatively connects the camera 60 to the cable connector 44. A single-lumen tube may also include the features described herein, including a first lumen 202, a camera 60, an LED 206, and the wiring harness 70 positioned within the illumination lumen 208 located in the wall of the tube 200.

[0065] Figure 13 A VPA 240 with a display screen 244 is shown. The VPA 240 includes a housing 242 and one or more cable connector receivers 246 configured to receive the cable connector 244. The housing 242 supports the display screen 244 and is assembled integrally with the display screen, which is referred to as an "integrated" display screen, in contrast to a "detached" display screen. The terms "integrated" and "detached" reflect the device being in an assembled form during use, in contrast to a device being in an unassembled or disassembled form. Figure 14 The image shows the VPA260 without the display 244, previously in Figure 3 The image shown depicts a split display 90. The VPA260 includes a housing 262 and one or more cable connector receivers 246 configured to receive a cable connector 44. In both the VPA240 and VPA260, the split display can communicate with it via Ethernet, wireless, AVI, HDMI, or other data interfaces, as known in the art. When connected to the invasive medical device 40, the VPA240 or 260 presents images or video streams on the monolithic and / or split display, as known in the art.

[0066] The preceding description describes an invasive medical device comprising: a proximal end and a distal end spaced apart from the proximal end; a camera positioned at the distal end; and a harness consisting of two coaxial cables having a common shield, extending from the proximal end to the distal end and electrically connected to the camera at the distal end. In some embodiments, but not in others, the invasive medical device includes a tubular member defining an internal lumen extending from the proximal end to the distal end of the device. The two coaxial cables comprise a total of five conductors, including a ground conductor, a camera power conductor, an illumination power conductor, a clock conductor, and a video signal conductor. Embodiments of the harness 70 are described below.

[0067] Now let's turn our attention to... Figure 15An embodiment of the wire harness 70 is shown. The wire harness 70 includes a first coaxial cable 308 and a second coaxial cable 310 disposed within a common shield 74. The first coaxial cable 308 includes a center conductor 312, an insulator 304, and a shield 314. The insulator may be, for example, a perfluoroalkoxy form. The center conductor 312 may be an electric wire or a stranded wire comprising two or more strands (e.g., seven strands). The shield of the first coaxial cable 308 may be formed of braided or spiral wires surrounding the insulator. The shield 314 is conductive and constitutes conductor 72. Preferably, the shield is not formed of aluminum foil, as the resistance of such aluminum foil is considered too high to effectively constitute the conductors in this disclosure. Similarly, the second coaxial cable 310 includes a center conductor 316, an insulator 304, and a shield 318. The center conductor may be an electric wire or a stranded wire comprising two or more strands. The shield 318 of the second coaxial cable 310 may be formed of braided or spiral wires surrounding the insulator. The shield 318 is conductive and forms the conductor 72. Preferably, the shield is not formed of aluminum foil, as the resistance of such aluminum foil is considered too high to effectively form the conductors in this disclosure. The coaxial cable may have an insulator 304 disposed on the outer surface of the shield. The insulator may be varnish, which allows for very compact cable bundles, but such varnish is generally fragile and may deteriorate during the assembly or use of invasive medical devices. Therefore, a coating such as perfluoroalkoxy (PFA), polyethylene (PE), or polypropylene (PP) is currently considered a better option for the coaxial cable. The first and second coaxial cables may be identical, which would provide simplicity and potentially low cost, but may differ, for example, where improved shielding of one or more conductors is considered beneficial, or where resistance is a concern for one or more conductors. The common shield 74 may be formed of braided wire, spiral wire, or a wrapping or foil (such as a tinned copper wrapping). The common shield 74 is conductive and electrically connected to ground. The common shield 74 may include two layers (such as two braids stacked together) to improve the strength and durability of the cable bundle, which may be advantageous for handling during manufacturing. The common shield may be provided with an insulator, such as a sheath 306 made of insulating material. The insulator can be a protective sleeve or sheath 306, which provides strength to the cable bundle, thus allowing the use of smaller gauge wires. Alternatively, the insulator can be varnish, thereby enabling very compact cable bundles; however, this increases the risk of wire breakage or varnish deterioration during production or use, all of which can lead to loss of real-time images or negatively impact image quality. The wires are selected based on their current-carrying capacity and physical strength, and therefore may be larger or smaller depending on their function. To reduce the size of the tubular structure and increase its flexibility, it is desirable to use the smallest wire capable of performing the selected function.Therefore, one wire may be larger than the other. The resistance of the wire, and thus the voltage drop over its length, is another limiting factor in some functionalities. For example, a voltage drop that is too large due to a wire diameter that is too small can cause image degradation in the video signal conductors of the harness. The inventors have discovered that specific combinations of wire, shielding, and conductor placement result in very good electrical noise reduction for, for example (but not exclusively) crosstalk between the clock and video signals.

[0068] like Figure 15 The cable bundle 70 depicted can operate with an image sensor including four connection pads. Such image sensors and pad arrangements have been developed to reduce the size of the image sensor. The cable bundle 70, consisting of two coaxial cables 308, 310 within a common shield 74, enables a very compact cable bundle construction with a flat configuration having a height h approximately half the width w. The flat configuration of the cable bundle 70 may be advantageous in some endoscope constructions because the low height h means that the cable bundle 70 can be integrated into the endoscope with very little impact on the endoscope diameter. Therefore, the reduction in the cable bundle profile benefits from a smaller cross-sectional area of ​​the invasive medical device 40 and allows for the use of a smaller camera.

[0069] Figure 16 It is based on variant A. Figure 15 A schematic diagram of the cable bundle 70 of an embodiment is shown. The first coaxial cable 308 includes two conductors 72 as described above, namely a center conductor 312, which in this variant is electrically connected to the camera and carries the video signal conductor V-out (output voltage), while a shield 314 is electrically connected to a light source and configured to supply power to the light source. The second coaxial cable 310 includes two conductors as described above. A center conductor 316 is electrically connected to the camera and configured to transmit the video clock signal CLK, while a shield 318 is electrically connected to the camera and configured to supply power to the camera's VCC. A common shield 74 electrically connects both the camera and the LED to ground (GND). With this arrangement, crosstalk between the clock signal and the video signal is highly reduced because both signals are protected by the shield. Furthermore, HF noise, such as that from electrosurgical instruments, is highly reduced because the signal is protected by the common shield 74 and individual shields of the two coaxial cables 308, 310.

[0070] Figure 15A variant B is shown in the schematic diagram of the cable bundle 70 of the embodiment. The first coaxial cable 308 includes two conductors as described above: a center conductor 312 and a shield 314. In this variant, the center conductor is electrically connected to the camera and configured to transmit the video clock signal CLK. The shield is electrically connected to the light source and configured to supply power to the LED. The center conductor 316 of the second coaxial cable 310 is electrically connected to the camera and configured to transmit the video signal V-out, while the shield 318 is electrically connected to the camera and configured to supply power to the camera's VCC. A common shield 74 electrically connects ground (GND) to both the camera and the LED. With this arrangement, crosstalk between the clock signal and the video signal is also highly reduced because both signals are protected by the shield. Furthermore, HF noise, such as that from electrosurgical instruments, is highly reduced because the signal is protected by the common shield 74 and individual shields of the two coaxial cables 308, 310. Variant B may be advantageous when lighting intensity is altered by increasing or decreasing LED power, particularly when managing lighting intensity through pulsating LED power. Changing LED power, especially pulsating LED power, can introduce electrical noise into the center conductor. The video signal V-out is generally considered more sensitive to electrical noise than the clock signal CLK; therefore, it is considered advantageous to provide LED power and video signal V-out on separate coaxial cables.

[0071] The center conductor of a coaxial cable should be as small as possible to provide a smaller cable profile, taking into account the resistance of the conductors, which increases as the cross-sectional area of ​​the conductor decreases. The center conductor can be a single wire or a combination of two or more strands. Wire sizes for center conductors in the 40 to 44 American Wire Gauge (AWG) range are generally considered a compromise suitable for this embodiment, but may be larger for other embodiments, such as 38 AWG, or smaller, such as 46 AWG, 48 AWG, or even 50 AWG. 40 AWG corresponds to an outer diameter of 0.079 mm for a single wire, while 44 AWG corresponds to an outer diameter of 0.051 mm for a single wire, and the conductor resistances are, for example, 3.8 Ohm / m and 9.1 Ohm / m, respectively. If it is a multi-strand type, the diameter of the center conductor is larger. The conductor resistance also depends on the conductor material (e.g., copper or a special alloy), whether the conductor is a single wire or multi-strand, and whether the wire or wire strands are additionally, for example, tin-plated or silver-plated. The outer diameter of the coaxial cable also depends on the thickness of the insulation, etc. For a 40AWG 7 wire with a center conductor, the example outer diameter of the coaxial cable is 0.33mm to 0.37mm, while for a 46AWG 7 wire with a center conductor, the example outer diameter is 0.22mm to 0.24mm. Stranded wires are more flexible than single wires, but they take up more space.

[0072] In the example of variant B, the first coaxial cable 308 is larger than the second coaxial cable 310. In one example, the first coaxial cable 308 is at least 42 American wire gauge (AWG) wire, and can be larger (e.g., 40 AWG wire), while the second coaxial cable 310 is at most 44 AWG wire, preferably 46 AWG wire. The wire gauge can also be based on the cable length. If the image sensor cable (inside the device) is less than 300 mm, a finer gauge can be used compared to a longer cable.

[0073] In another variation C of this embodiment, the conductors include conductors of the same type and size.

[0074] The variations of this implementation scheme can be combined to form additional variations of the implementation scheme. Therefore, variations A and B can be combined with variation C in a new variation.

[0075] In this variation, a single conductor serves as a shared power line for the LED and the camera, thus avoiding separate power lines for the camera and LED. However, the power requirements of the camera and LED are often different, so a voltage regulator or other power distribution device would be needed to distribute the power supplied by the shared power line to the camera and LED. Avoiding power distribution devices at the distal end of the invasive medical device also allows for a reduction in the size of the invasive portion (e.g., the distal end) of the device. A separate power line for the LED also allows for the potential up-and-down or pulsed power regulation of the illumination, which could have a positive impact on image quality.

[0076] Separating the video signal from the clock line can significantly reduce electrical noise from clock signal crosstalk. The video signal line can be used to transmit analog output signals from the camera as well as control signals between the camera and the VPA. The analog output signals include video frames and images. Control signals can be provided via a Serial Peripheral Interface (SPI) and multiplexed with analog signals, and can include gain and exposure camera settings.

[0077] The electrical shield can disconnect the electrical connection at the far end of the wire harness. The wire harness has a near end. The electrical shield can only be grounded at the near end of the wire harness. The electrical shield can be made of braided or spiral wire. Other types of electrical shields can also be used.

[0078] Uninsulated wires range in size (e.g., diameter) from 36AWG to 50AWG. AWG stands for American Wire Gauge. Wire dimensions are given in ASTM standard B 258 (ASTM B258-18). The AWG table applies to single solid round conductors. The AWG of multi-strand wires is determined by the cross-sectional area of ​​the equivalent solid conductor. Because there are small gaps between the strands, the total diameter of a multi-strand wire is always slightly larger than that of a solid wire of the same AWG. For example, the outer diameter of a 36AWG wire is 0.127 mm. The outer diameter of a 32AWG wire is 0.202 mm. The outer diameter of a 40AWG wire is 0.080 mm. The outer diameter of a 42AWG wire is 0.063 mm. The outer diameter of a 44AWG wire is 0.050 mm. The outer diameter of a 46AWG wire is 0.040 mm. In one example, the 40AWG wire has an insulation thickness of 0.040mm, a shield thickness (braided) of 0.020mm, an outer insulation of 0.030mm on the shield, an outer shield thickness of 0.060mm (double braided), and an outer sheath thickness of 0.080mm, resulting in a total outer width of 0.800mm and a height of 0.540mm for the cable bundle.

[0079] Typically, all wires are 38 AWG in size, but can be 38, 40, 42, 44, 46, 48, or 50 AWG. Smaller wire gauges can help reduce the cross-sectional dimensions of the invasive portion of the medical device and increase bending flexibility, but at the expense of noise sensitivity. Larger wire gauges may be preferred when size reduction is not required.

[0080] Tests were conducted to examine the sensitivity of invasive medical devices to electrical noise generated by electrosurgical instruments. Tests were also performed to determine the high-frequency (HF) immunity of a 1m long, 44AWG dual-coaxial shielded cable. The electrosurgical instrument used was equipped with an APC3 module and a FIAPC probe 2200A. 3.2mm, 2.2m in length (5kVp) The cable was found to have excellent performance and no interference, resulting in good image quality.

[0081] Previous testing on other wire types revealed interference issues. For example, tests were conducted on a single wire (non-coaxial). The problems were found to be related not only to interference with the video signal but also to interference with the camera's power supply. In the tests, the camera power supply was 3.42V DC, but interference was found to affect the voltage measured at the camera's end, resulting in measured voltages ranging from 1.88V to 4.98V. The minimum voltage required for normal camera operation is 3.14V, and even a low voltage of 1.88V measured for only a short time (~4ns) was sufficient to trigger a camera restart. Camera resets and restarts caused image flickering.

[0082] Although some embodiments have been described and illustrated in detail, the invention is not limited thereto, but may be practiced in other ways within the scope of the subject matter defined in the appended claims. Specifically, it should be understood that other embodiments may be utilized and structural and functional changes may be made without departing from the scope of the invention.

[0083] In an equipment claim that enumerates several means, some of these means may be implemented by the same hardware component. The mere fact that certain measures are described in different dependents or in different embodiments does not imply that a combination of these measures cannot be used advantageously.

[0084] The terms “first,” “second,” etc., as used in the specification and claims (if any) are used to distinguish similar elements and are not necessarily used to describe a particular sequence or temporal order. It should be understood that any terms thus used are interchangeable where appropriate, such that the embodiments described herein can, for example, operate in a sequence different from that shown or otherwise described herein.

[0085] It should be emphasized that the term "comprising / including" is generally interpreted as an open-ended term, specifying the presence of the stated feature, integer, step, or component, but not excluding the presence or addition of one or more other features, integers, steps, or components, or groups thereof. The terms "consisting of" or "comprises of" are closed-ended terms and include only the components, structures, steps, etc., specifically listed in conjunction with such terms and in accordance with U.S. patent law.

[0086] Figure label:

[0087]

[0088]

[0089]

Claims

1. An invasive medical device, comprising: The proximal end (40p) and the distal end (40d) spaced apart from the proximal end; A tubular member (50) having an internal cavity (54) extending from the proximal end to the distal end; A camera (60) and a light source are positioned at the far end; as well as A cable bundle (70) comprising a first coaxial cable (308) and a second coaxial cable (310) located within a common electrical shield (74), the cable bundle extending from the proximal end to the distal end and the distal end being electrically connected to the camera and the light source; The first coaxial cable (308) includes a first cable center conductor (312), a first cable insulation layer, and a first cable shield (314); The second coaxial cable (310) includes a second cable center conductor (316), a second cable insulation layer, and a second cable shield (318); One of the first cable shield or the second cable shield is electrically connected to the light source and is configured to supply power; The first cable shield or the other of the second cable shields is electrically connected to the camera and is configured to supply power; One of the first cable center conductors or the second cable center conductors is electrically connected to the camera and configured to transmit video signals; The center conductor of the first cable or another of the center conductors of the second cable is electrically connected to the camera and is configured to transmit a clock signal; and The common power shield (74) connects the ground power to the camera and the light source.

2. The invasive medical device as described in claim 1, wherein, The coaxial cable is unstretched.

3. The invasive medical device as claimed in claim 1 or 2, wherein the first cable shield is electrically connected to the light source and configured to supply power; the center conductor of the first cable is electrically connected to the camera and configured to transmit the video signal; The second cable shield is electrically connected to the camera and is configured to supply power. The center conductor of the second cable is electrically connected to the camera and is configured to transmit the clock signal.

4. The invasive medical device as claimed in claim 1 or 2, wherein the first cable shield is electrically connected to the light source and configured to supply power; the center conductor of the first cable is electrically connected to the camera and configured to transmit the clock signal; The second cable shield is electrically connected to the camera and is configured to supply power. The center conductor of the second cable is electrically connected to the camera and is configured to transmit the video signal.

5. The invasive medical device as described in any one of claims 1 to 4, wherein the coaxial cable has a central conductor with a maximum cross-sectional area of ​​0.0005 mm². 2 Up to 0.0050mm 2 Within the range, for example, in 0.0008mm 2 Up to 0.0032mm 2 Within the range, for example, 0.0012mm 2 Miniature coaxial cable.

6. The invasive medical device as described in any one of claims 1 to 5, wherein, The height of the cable bundle is in the range of 0.1mm to 0.7mm, for example, in the range of 0.2mm to 0.6mm, such as 0.35mm.

7. The invasive medical device according to any one of claims 1 to 6, wherein, The width of the cable bundle is in the range of 0.2mm to 0.9mm, for example, in the range of 0.4mm to 0.75mm, such as 0.60mm.

8. The invasive medical device as described in any one of claims 6 to 7, wherein, The ratio of the height to the width of the cable bundle is in the range of 0.55 to 0.75, for example, 0.

67.

9. The invasive medical device as claimed in any of the preceding claims, wherein, The invasive medical device includes an endoscope, which comprises: The proximal end includes a positioning interface (146) with a distal end; An insert cable (150) is connected to and extends from the distal end of the positioning interface, and includes an insert tube (152), a bend (160), and an end housing (170). The camera is positioned within the end housing, and the tubular member extends from the positioning interface through the insert tube to the end housing. The wiring harness extends from the positioning interface to the end housing.

10. The invasive medical device as claimed in claim 8, wherein, The curved portion includes a range of 1.8mm to 6.0mm, such as a range of 2.0mm to 3mm, such as a diameter of 2.5mm.

11. The invasive medical device as described in claims 5 and 10, wherein, The ratio of the cable bundle height to the diameter of the bend is less than 0.2, for example, in the range of 0.04 to 0.16, or approximately 0.

1.

12. A visualization system (20) comprising: Invasive medical devices (40, 140, 200) as described in any of the preceding claims; as well as A video processing device (30) is configured to communicate with the invasive medical device to receive video streams from the invasive medical device.

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