WO2020003192A1

WO2020003192A1 - Wireless laryngoscope

Info

Publication number: WO2020003192A1
Application number: PCT/IB2019/055449
Authority: WO
Inventors: Jacques Albert DE VILLIERS; Dylan EAVE; Christiaan Tertius DE VILLIERS; Jeandré BRIEDENHANN
Original assignee: De Villiers Jacques Albert
Priority date: 2018-06-29
Filing date: 2019-06-27
Publication date: 2020-01-02
Also published as: GB2575110A; GB201810749D0; ZA202100626B

Abstract

There is provided a wireless laryngoscope (10) comprising a body (12) formed as a single part. The laryngoscope includes a handle (14) extending along a first axis (36) and having a compartment (24) therein. An insertion member (16) extends from the handle towards a tip (22), and a mount (64) for a camera (18) is located towards the tip. A guide (56) for a cable extends between the mount (64) and the compartment (24). The compartment houses a power source (30) and a wireless transmitter (28) for transmitting digital images or video recorded by the camera. The mount includes a section of substantially straight tube that has a second axis (67) for holding the camera therein aligned with the second axis so that the camera observes a field of view at the tip of the insertion member.

Description

WIRELESS LARYNGOSCOPE

CROSS-REFERENCE(S) TO RELATED APPLICATIONS

This application claims priority from United Kingdom patent application number GB1810749.0 filed on 29 June 2018, which is incorporated by reference herein.

FIELD OF THE INVENTION

This invention relates to laryngoscopy.

More particularly, but not exclusively, this invention relates to a wireless laryngoscope for facilitating intubation of a mammal.

BACKGROUND TO THE INVENTION

Endoscopy is a procedure used in the medical field to look inside the human or animal body. Laryngoscopy is one form of endoscopy and comprises a medical procedure wherein endoscopy of the larynx is performed. The larynx is an organ (sometimes referred to as the voice box) near the top of the neck of a mammal. Laryngoscopy may for example be utilised to obtain a view of the vocal cords and the glottis. This is often required to facilitate tracheal intubation during general anaesthesia or during cardiopulmonary resuscitation. Laryngoscopes may also be used for other surgical procedures on the larynx or to obtain a view of other parts of the throat. Due to its inherent uncomfortable nature, laryngoscopy is usually only performed on patients that are unconscious. Two of the known methods of performing laryngoscopy are direct laryngoscopy and indirect laryngoscopy.

Direct laryngoscopy is performed with a patient lying on his or her back and generally requires bending the patient’s neck backwards which may result in an inadvertent hyperextension of the patient’s neck. The laryngoscope is then inserted into the patient’s mouth and the tongue is moved away in an effort to obtain a direct line of sight to the glottis, so that intubation may be performed. Direct laryngoscopy may only be performed in some circumstances, and is sometimes not possible at all, for example in cases where the patient’s anatomy prevents or inhibits the required backward bending or hyperextension of the neck. Direct laryngoscopy is also not possible when the patient’s neck has been injured or a neck injury is expected, because the neck is either braced or must be kept as still as possible to prevent further damage to the neck. Indirect laryngoscopy is performed when the patient is intubated without a direct line of sight to the glottis or trachea. Other means of obtaining a view of the glottis is then provided, such as a mirror or a video camera. A video laryngoscope provides video feedback to a user thereof, to guide the user towards the glottis and trachea when for example inserting an artificial ventilation tube into the trachea during an intubation procedure. However, some of the known video laryngoscopes are tethered and have one or more wires emanating from their handles, which is cumbersome and inhibits the user from moving the laryngoscope freely while performing laryngoscopy. Other known video laryngoscopes have video displays permanently mounted to their handles, however these displays may get in the way while performing laryngoscopy and the display also adds to the cost of the device. The tethered and/or permanently mounted display arrangements may also inhibit insertion of the laryngoscope when a patient has an abnormally large chest or neck. Known video laryngoscopes are notoriously expensive, often prohibitively so. This means that, especially in developing countries, not enough of these video laryngoscopes are available. The known tethered video laryngoscopes also generally require a fixed power source and are usually not provided in mobile environments such as ambulances or elsewhere in the field where laryngoscopy may be required. In some instances, and due to their high cost, only one video laryngoscope is provided for an entire hospital if one is available at all.

There is scope to address the aforementioned shortcomings, disadvantages and problems.

The preceding discussion of the background to the invention is intended only to facilitate an understanding of the present invention. It should be appreciated that the discussion is not an acknowledgment or admission that any of the material referred to was part of the common general knowledge in the art as at the priority date of the application.

SUMMARY OF THE INVENTION

In accordance with this invention there is provided a wireless laryngoscope comprising a body formed as a single part, the single part including a handle extending along a first axis and having a compartment therein, a curved or angled insertion member extending from the handle towards a tip, a mount for a camera located towards the tip, and a guide for a cable that extends between the mount and the compartment, wherein the compartment houses a power source and a wireless transmitter for transmitting digital images or video recorded by the camera, and wherein the camera mount includes a section of substantially straight tube that has a second axis for holding the camera therein aligned with the second axis so that the camera observes a field of view at the tip of the insertion member, the insertion member being angled or curved from the first axis at the handle to the second axis towards the tip, through a total angle of more than 100 degrees. A further feature provides for the single part to be made from injection-moulded plastics.

Still further features provide for the insertion member to be angled or curved from the first axis to the second axis through a total angle of about 1 15 degrees, or about 120 degrees, or between 100 and 135 degrees, alternatively between 1 10 and 135 degrees, further alternatively between 1 10 and 130 degrees, or more than 135 degrees.

Yet further features provide for the insertion member to have uneven sides with protruding or recessed structures which become fouled during use, to thereby dissuade a user from cleaning the laryngoscope for reuse; for the cable to connect the wireless transmitter to the camera; for the guide to be formed at least partially by a groove along an outer surface of the handle for receiving the cable; and for the groove to include gripping formations for gripping the cable when it is inserted into the guide.

Further features provide for the handle to have a base at one end of the handle which is furthest from the tip; for the base to at least partially define a flat surface extending along a plane that is angled between 30 and 60 degrees from the first axis; for the handle to be a straight tubular or hollow section of the body; for the insertion member to curve or to be angled to a first side of the handle’s axis; and for the handle to have a rim which opens into the chamber, wherein at least a portion of the rim extends in a plane that is angled between 30 and 60 degrees towards the first side of the handle’s axis.

Still further features provide for the insertion member to have a portion along its length adjacent the handle that defines a first section and a subsequent portion along its length that defines a second section; for the first section and second section to be angled relative to each other; for the second section to include the mount for holding the camera; for a cover to be provided at the mount for operatively shielding the camera; and for a wedge to be provided adjacent a tip of the insertion member.

A further feature provides for the laryngoscope to be provided in a hermetically sealed single-use package, such that the laryngoscope is intended for disposal after single use thereof; for the single use package to have a line of weakness or frangible portion; for the line of weakness or frangible portion to be damaged, broken or severed upon opening the package; for the package to be configured such that re-sealing thereof is inhibited or prevented; and for the package or the laryngoscope itself to include markings indicating single use. Yet further features provide for the body to be elongate and to extend in a plane and to have a width perpendicular to that plane, the width of the insertion member decreasing towards its tip so as to form the wedge adjacent the tip.

A further feature provides for the wireless transmitter to be configured to transmit the images recorded by the camera to a mobile device.

Further features provide for one or both of the first and second sections or the insertion member to include a guideway for operatively enabling an intubation member to pass along the guideway; and for the guideway to be provided in an outer surface of one of the first and second sections.

Still further features provide for a cross section of one of the first and second sections or for a cross section of the insertion member to be at least partially Z-shaped, or to be at least partially inverted Z-shaped, so as to enable the laryngoscope to operatively apply pressure to soft tissue with one side of the cross section while enabling the intubation member to pass on the other side of the cross section; and for at least part of the guideway to be defined by the Z-shaped or inverted Z-shaped cross section.

A yet further feature provides for the power source to be a battery; for the battery to include a pull tab or insulator that activates the battery upon removal of the pull tab or insulator, such that the battery provides power to the wireless transmitter; for the pull tab or insulator to be provided between terminals of the battery such that the terminals are connected when the pull tab or insulator is removed; for the battery and/or wireless transmitter to be permanently embedded or enclosed in the body of the laryngoscope, for example during manufacture thereof, or for the battery and/or wireless transmitter to be enclosed in the compartment, preferably permanently enclosed (for example by using an adhesive, a seal or a lid for the compartment); for the pull tab or insulator to extend through an aperture in the body to be removed from externally of the body which may activate the laryngoscope; and for the battery to be arranged to provide power to the wireless transmitter only for a limited time, or only until the battery is depleted, such that the laryngoscope is intended for disposal after single use thereof; and for the wireless transmitter to be arranged to automatically pair with the mobile device once the battery is activated as aforesaid, and to continue to transmit images or video recorded by the camera for a limited time, whereafter the transmitter may be automatically deactivated.

Further features provide for the wireless transmitter to be a Wi-Fi or Bluetooth™ transmitter capable of transmitting to a mobile device. A still further feature provides for a light to be provided at or near the tip for illuminating the field of view of the camera.

Yet further features provide for the body to be made by an injection moulding process; and for the body to be made of a single part which is formed by the injection moulding process, for example by using a mould having two main moulds; and optionally for the mould to include a first mould insert which is inserted between the two main parts to form the chamber in the handle during the moulding process, or alternatively for the chamber in the handle to be formed by one of the two main parts of the mould; and for the body to be made of a material comprising one of a polymer, a plastic and a polycarbonate.

Further features provide for the laryngoscope to be manufactured by an additive manufacturing method (for example utilising one of the 3D printing technologies), or a subtractive manufacturing method (for example machining or other material-removing processes), or a manufacturing method that utilises a mould (such as injection moulding or casting), or a combination of these methods; and for the compartment in the handle to be formed after the laryngoscope has been moulded, by subtractive manufacturing such as machining, drilling or any other material-removing process.

According to a further aspect of the invention there is provided a system including a wireless laryngoscope as previously described, and a mobile device in wireless data communication with the laryngoscope, the mobile device having a display which is operable to display images or video recorded by the camera.

Further features provide for the system to include a central server; and for the mobile device to be in data communication with the server; and for a purpose-created mobile application to be downloadable and installable on the mobile device to facilitate operation of the system.

Still further features provide for the system to include a remote supervision station in data communication with the server and/or with the mobile device, the remote supervision station including a supervision display configured to display the field of view of the camera in real time or near real time, to enable a remote supervisor to supervise and/or to provide assistance to a user of the laryngoscope.

Yet further features provide for the mobile device to be operable to receive a data stream of the images recorded by the camera. According to a further aspect of the invention there is provided a method of manufacturing a body of a laryngoscope as previously described, the method comprising: providing a first main mould and an opposite second main mould, the first and second main moulds when connected defining a cavity to form the laryngoscope as a single part including the handle, the insertion member and the mount for the camera, placing a first mould insert into the cavity between the first and second moulds, the first mould insert defining the compartment in the handle; and placing a second mould insert into the cavity between the first and second moulds, the second mould insert defining the section of substantially straight tube of the mount; and injection moulding the laryngoscope by filling the voids between the first and second moulds with plastics material.

A further feature provides for the method to include manufacturing a wireless laryngoscope as previously described; and for the method to include the step of inserting the wireless transmitter into the compartment.

Still further features provide for the method to include the steps of: mounting or installing the camera to the mount; providing a cable to couple the camera to the wireless transmitter or to a transmitting module including the wireless transmitter; placing the cable into the guide that may be provided along an outer surface of the handle or that may tunnel through the body; and coupling the camera to the wireless transmitter with the cable.

In order that the above and other features of the invention may be more fully understood various embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

Figure 1 is a high level diagram of a system including a wireless laryngoscope and a mobile device in wireless data communication with a transmitting module of the laryngoscope;

Figure 2 is a side view of the laryngoscope showing a handle having an axis and an insertion member extending from the handle and a groove provided along an outer surface of the handle; Figure 3 is an opposing side view of the laryngoscope of Figure 2, showing a guideway in the insertion member;

Figure 4 is a sectional view of the insertion member of the laryngoscope taken along line A-A in figure 3;

Figure 5 is a front view of the laryngoscope showing a mount for a camera; Figure 6 is a three dimensional view of the laryngoscope, showing the device in more detail;

Figure 7 is a three dimensional view of the laryngoscope, seen from the opposite side than in Figure 6, and also showing a cable installed;

Figure 8 is a top view of the laryngoscope, showing a transmitting module, the cable and a camera installed;

Figure 9 illustrates an approximate orientation of the laryngoscope prior to insertion of the insertion member into a patient;

Figures 10,1 OA illustrate example movements of the laryngoscope, performed during insertion of the insertion member into the patient;

Figure 1 1 illustrates an example orientation of the laryngoscope after the insertion member is inserted into the patient;

Figure 12 is the sectional view of Figure 4, but also showing a diagrammatic representation of how pressure is applied to soft tissue utilising the laryngoscope;

Figure 13 is a rear view of the laryngoscope, showing the guideway in more detail; Figure 14 is a side view of the laryngoscope similar to Figure 3, however with the laryngoscope rotated 90 degrees and showing an intubation member passing along a part of the guideway; Figure 15 is a high level block diagram of the system of Figure 1 , also including a backend or central server and a remote supervision station;

Figure 16 is a diagrammatic representation of a method of manufacturing the laryngoscope, showing a mould for use in the method; and

Figure 17 is a three dimensional view of the laryngoscope after it has been moulded, showing a feeding gate used in the injection moulding process.

DETAILED DESCRIPTION WITH REFERENCE TO THE DRAWINGS

A wireless laryngoscope (10) is shown in Figures 1 to 17, a system (100) including the laryngoscope is shown in Figures 1 and 15, and a method (500) of manufacturing the laryngoscope is shown in Figures 16 and 17. Throughout the figures, like features may be referenced with like numerals.

Referring to Figures 1 to 8, the wireless laryngoscope (10) has a body (12) that includes a handle (14) and an insertion member (16) extending from the handle and provided with a camera (18) which observes a field of view (20) at a tip (22) of the insertion member (16) remote from the handle (14). The wireless laryngoscope (10) may be formed as a single part, the single part including the handle (14) extending along a first axis (36) and having a compartment or chamber (24) therein. The insertion member (16) may be curved or angled and extend from the handle (14) towards a tip (22). A mount (64) for a camera (18) may be located towards the tip (22). The wireless laryngoscope (10) may further include a guide or groove (56) for a cable (32) that extends between the mount (64) and the compartment (24). The compartment (24) may house a power source (30) and a wireless transmitter (28) for transmitting digital images or video recorded by the camera (18). The camera mount (64) may include a section of substantially straight tube that has a second axis (67) (shown in Figure 2) for holding the camera (18) therein aligned with the second axis (67), so that the camera may observe a field of view at the tip (22) of the insertion member (16). the insertion member (16) may be angled or curved from the first axis (36) at the handle (14) to the second axis (67) towards the tip (22), through a total angle (29) of more than 100 degrees. The total angle (29) may be between 100 and 135 degrees, alternatively between 1 10 and 135 degrees, further alternatively between 1 10 and 130 degrees, or about 1 15 degrees, or about 120 degrees, or more than 135 degrees. The total angle (29) may provide an angled field of view of the camera relative to the handle (14), which may facilitate intubation. As is shown in Figures 5 to 8, the handle (14) may include a chamber (24) therein, for housing a transmitting module (26) that includes a wireless transmitter (28) and a power source (30). As is shown in Figure 8, the transmitting module (26) may be coupled with a cable (32) to the camera (18) and may be operable to wirelessly transmit images recorded by the camera (18). In the embodiment shown, the transmitting module (26) is operable to wirelessly transmit a video stream of the field of view (20) observed by the camera to a mobile device (34) for display on a display (35) associated with the mobile device (34). The transmitting module (26), the wireless transmitter (28) and the camera (18) are powered by the power source (30), which is preferably in the form of a battery. The wireless transmitter (28) may utilise Wi-Fi, Bluetooth, or other wireless technology capable of transmitting to the mobile device (34). A light may be provided at or near the tip (22) for illuminating the field of view (20) of the camera (18). The light may for example be one or more light-emitting diodes (LED’s) arranged side by side with the camera (18). The camera and LED’s may form part of a borescope or fiberscope which may be pre-manufactured prior to installation into the laryngoscope (10). The light may be arranged to provide a source of heat to the camera, which may provide the advantage of inhibiting fog, mist or moisture from forming on a lens of the camera (18) during insertion.

Referring to Figure 2, the handle (14) may be a straight tubular or hollow section of the body (12), and extends along the first axis (36). The insertion member (16) may be curved or angled to a first side (38) of the handle’s axis (36) and the handle may have a rim (40) which opens into the chamber (24). At least a portion (42) of the rim extends in a plane (45) that is angled between 30 and 60 degrees towards the first side (38) of the handle’s axis (36). In the embodiment shown, the portion (42) of the rim (40) is angled at 40° relative to the axis (36), or stated differently, the portion (42) of the rim (40) is disposed at an angle (43) which may be about 50 ° relative to a line (44) perpendicular to the axis (36) of the handle. The handle may have a base (41 ) at one end of the handle which is furthest from the tip (22), and the base may at least partially define a flat surface (42) (the flat surface may coincide with part of the rim) extending along a plane (45) that is angled (47) between 30 and 60 degrees from the first axis. In other words, the angle (47) of the flat surface (42) may be between 30 and 60 degrees, as measured from the first axis (36).

The body (12) may be elongate and extend in a plane (46) (shown in Figures 5 and 8). The body (12) of the laryngoscope (10) may have a width (48, 50) perpendicular to the plane (46). As shown in Figure 8, the width of the insertion member (16) decreases from a first width (48) to a second (and smaller) width (50) at the tip (22) so as to form a wedge (52) adjacent the tip (22).

The handle (14) may include a groove or guide (56) provided along an outer surface of the handle for receiving the cable (32) that connects the transmitting module (26) to the camera (18). In the embodiment shown, the groove includes one or more gripping formations (58) for gripping the cable (32) when it is inserted into the groove (as shown in Figure 1 ), however embodiments are possible wherein these gripping formations may be omitted. The insertion member (16) may include a first section (60) and a second section (62) that may be curved or angled relative to each other. A passage (63) (shown in Figure 6) may be provided in the insertion member (16), for receiving the cable (32), to enable it to pass through the body (12) as is shown in Figure 8. The passage (63) may also form part of the guide (56) and may extend through part of the handle to the chamber or compartment (24). Embodiments are possible wherein the guide (56) is not provided adjacent the side of the handle (14), but instead extends from internally of the compartment (24) through the body (the guide may thus“tunnel” through part of the body or through part of the insertion member) towards the mount (64). If the guide tunnels through part of the body, the laryngoscope may be configured to have a streamlined look and feel, or to have an integrated structure which may facilitate use thereof, because of the cable extending through the tunnelling guide inside the body. The second section (62) may include the mount (64) for holding the camera (18). A cover (66) may also be provided at the mount (64) for operatively shielding the camera (18), which may protect the camera (18) when the laryngoscope (10) is inserted as described below. A guideway (68) may be provided in an outer surface of the first and second sections (60, 62) (or in an outer surface of the insertion member), to operatively enable an intubation member (70) to pass through or along the guideway (68) (or to pass through or along part of the guideway as shown in Figure 14). It should be appreciated that the intubation member does not necessarily exit the guideway at the same angle or parallel to the second section (62) of the insertion member (16), which may be advantageous when performing intubation. Referring to Figure 4, a cross section of the first and second sections (60, 62) (or of the insertion member) may be at least partially in the shape of an inverted Z or in the shape of a Z. This inverted Z-shape may facilitate an insertion procedure of the laryngoscope (10) as will be discussed in more detail below. Optionally a flange, winged section, or extended part (79) (indicated by broken lines in Figure 4) of the cross section may be provided to facilitate the insertion procedure.

Referring to Figure 2, the insertion member (16) of the wireless laryngoscope (10) may have uneven sides with protruding or recessed structures (69) formed in the body (12), which may become fouled or dirty during use. These recessed structures and protruding structures may dissuade a user (74) from cleaning the laryngoscope (10) for reuse, which may facilitate non reusability and may encourage disposal after single use of the wireless laryngoscope. It is expected that these recesses and protrusions may, in use, become dirty and thereby dissuade the user (74) from using the wireless laryngoscope (10) more than once, because it may be intended for the laryngoscope (10) to be a single-use or disposable laryngoscope (10) which may be disposed after being used. Referring to Figures 9 to 14, to insert the insertion member (16) of the laryngoscope (10), a patient (72) may be positioned to lie flat on their back. The laryngoscope (10) is then positioned by the user (74), typically a medical practitioner, to about the orientation shown in Figure 9, with the plane (46) (shown in Figures 5 and 8) more or less perpendicular to a long axis (76) of a body of the patient (72). The medical practitioner would normally stand behind the patient’s head while performing the insertion procedure, however other arrangements are possible. Next, the user (74) introduces the tip (22) of the laryngoscope (10) into the patient’s mouth (78) and utilises the wedge (52) to pry apart the patient’s teeth and/or jaws as indicated by the arrows (80) in Figure 9. Once the tip (22) of the laryngoscope (10) is inside the patient’s mouth (78), pressure is applied to the patient’s tongue (82) (and/or other soft tissue) to move the tongue to one side of the inverted Z- shaped cross section as is illustrated by the diagrammatic representation in Figure 12. To facilitate this movement of the tongue, or soft tissue (82), the user (74) moves the laryngoscope deeper into the mouth (78) as indicated by a first directional arrow (86) in Figure 10, while also rotating the laryngoscope in a direction towards the long axis (76) of the patient’s body as indicated by a second directional arrow (84) in Figure 10. A corner (87) or hooking formation (shown in Figure 6) provided in the second section (62) of the insertion member (16) may also facilitate the movement of the tongue (82). The insertion and rotational movement (86, 84) is then continued until the laryngoscope (10) is in about the orientation depicted in Figure 10A. The laryngoscope (10) may be rotated in the direction of a third directional arrow (89) shown in Figure 10A until it reaches the orientation shown in Figures 1 , 1 1 and 15, with the patient’s tongue abutting the first and second sections (60, 62) of the insertion member (16). It should be appreciated that insertion of the laryngoscope (10) when a patient has an abnormally large chest or neck is facilitated by the angled portion (42) of the rim (40) of the handle (14) (or by the flat surface defined by the base of the handle), so that the laryngoscope may be manipulated to the orientation shown in Figure 10A. This orientation would not be possible, or would at least be inhibited by prior art devices that the applicant is aware of.

Referring to Figures 1 and 8, before insertion, the user (74) switches on the transmitting module (26) for example by pressing a button (75) provided thereon, and performs a pairing step which pairs the laryngoscope to the mobile device (34). Transmission of the video stream of the field of view (20) may then be initiated. During the insertion procedure described above, the user (74) is hence enabled to observe the video stream (or video feed) of the field of view (20) captured by the camera (18) which is wirelessly transmitted and displayed on the mobile device (34). The user may utilise the video displayed on the mobile device to guide the tip (22) of the laryngoscope to an epiglottis (88) of the patient (72), so that a view of the glottis (90) and/or trachea (92) may be obtained, to facilitate intubation. While performing this procedure, the tip (22) of the laryngoscope (10) may be positioned into a vallecula (99) adjacent the epiglottis (88), so that a base of the epiglottis may be moved and/or the epiglottis (88) itself may be moved out of the way, so as to reveal the vocal cords (97), the glottis (90) and/or the trachea (92) in the field of view of the camera (18). While the soft tissue (82) is moved and/or biased to one side of the inverted Z-shaped cross section (or Z-shaped cross section) in the insertion member (16), the intubation member (70) is also enabled to pass on the other side of the cross section through the guideway (68) as is shown in Figure 14. The intubation member (70) may for example be in the form of a tracheal tube, such as an endotracheal tube which is well known in the art (but other intubation members may be used when performing other forms of endoscopy). The intubation member (70) may be moved past the guideway (68) in a direction of a fourth directional arrow (73) at an angle (71 ) relative to the second section (62).

It should be appreciated that the laryngoscope (10) may automatically connect to the mobile device (34) or to any computing device including a screen which is in the vicinity of the laryngoscope (10). The laryngoscope (10) or mobile device (34) do not need to have Internet connectivity during the intubation process.

Referring to Figures 1 and 15, there is shown a system (100) that includes the wireless laryngoscope (10) and the mobile device (34) in wireless data communication with the transmitting module (26). The mobile device includes the display (35) which is operable to display the images recorded by the camera (18). The images are received wirelessly by the mobile device as a video stream of the field of view (20) observed by the camera, so that the field of view of the camera may be displayed in real time or in near real time to the user (74). In the embodiment shown in Figure 15, the system (100) also includes a central or backend server (102) in data communication with the mobile device (34), via a communications path, for example via the Internet (104). A purpose-created mobile application may be downloadable and installable on the mobile device (34) to facilitate operation of the system (100). The mobile application may also facilitate the pairing step between the laryngoscope (10) and the mobile device (34), or enable the pairing step to be performed automatically once the transmitting module (26) is switched on within wireless range of the mobile device (34) executing the mobile application. A computing device including a memory and a processor may be associated with the transmitting module (26) and firmware or software may be provided to facilitate communication between the transmitting module and the mobile device (34). The system (100) may further be provided with a remote supervision station (106) in data communication with the server (102) and/or with the mobile device (34), in this embodiment also over the Internet (104). The remote supervision station (106) may include a remote computing device (1 14) and a supervision display (108) whereon the field of view (20) of the camera (18) of the laryngoscope (10) may be displayed in real time or near real time, to enable a remote supervisor (1 10) to supervise and/or to provide remote assistance to the user (74) of the laryngoscope (10). A communication facility (1 12) may also be provided to enable the remote supervisor (1 10) to give verbal instructions or to otherwise direct the user (74) while performing the aforementioned insertion procedure and/or intubation of the patient (72). The communication facility (1 12) may be provided by a separate device (such as a smartphone) at the remote supervision station (106), or may be provided as a facility forming part of the application which may also be downloadable and installable onto the remote computing device (1 14).

It is further envisaged that implementations of the system (100) are possible wherein the application or other purpose-built software may be utilised to, in real time, analyse the field of view (20) observed by the camera and to utilise artificial intelligence (Al) and/or pattern recognition technologies to identify parts of the anatomy of the patient (72). For example, the mobile device (34) may be utilised to guide the user (74) to the glottis (90) by displaying names of parts of the anatomy when they are recognized by the Al software. A form of augmented reality or virtual reality may also be used. The Al and/or the pattern recognition may also be utilised to identify potential problems in the anatomy of the patient. Embodiments are possible wherein the images or video recorded by the camera (18) may be stored in a database at the server (102). These images may be used for training purposes, or to assist intubations by other users at a later stage. The images or video may be labelled by the Al software, or by the server (102) to assist users during the insertion procedure. The stored images, video and labels may be used by the Al software to intelligently guide users using the previously stored images, video and labels and superimposing the labels onto a live feed or real time feed from the camera displayed on the display (35). The system (100) may be utilised with the wireless laryngoscope (10), however the system may also be used with other wireless or video laryngoscopes and may receive images or video from these other laryngoscopes for storage, or the server (102) may send the superimposed labels to displays associated with these other laryngoscopes to guide users. It should also be appreciated that the laryngoscope (10) may connect to the mobile device (34) locally and embodiments are possible wherein the central server (102) and/or the remote supervision station (106) may be omitted.

In Figures 16 and 17 there is shown an example of a method (500) of manufacturing the laryngoscope (10). A mould (502) may be provided, the mould (502) having at least two main mould parts which may be referred to as an A-side (504) and a B-side (not shown). A plurality of further mould parts or inserts may be provided for forming cavities in the body (12) of the laryngoscope (10), including the chamber or compartment (24) in the handle (14), the passage (63) for the cable (32), and the mount (64) for the camera (18). The method may include: providing the first main mould (504) and the opposite second main mould, the first and second main moulds when connected defining a cavity to form the body (12) of the laryngoscope (10) as a single part including the handle (14), the insertion member (16) and the mount (64) for the camera. The method may include placing a first mould insert (506) into the cavity between the first (504) and second moulds. The first mould insert (506) may define the compartment in the handle (14). The method (500) may further include placing a second mould insert (507) into the cavity between the first (504) and second moulds. The second mould insert (507) may define the section of substantially straight tube of the mount (64). The method may further include injection moulding the laryngoscope (10) by filling the voids between the first and second moulds with plastics material. A third mould insert (509) may be provided for forming the passage (63) or the guide for the cable (in the case of the guide extending from internally of the compartment through the body towards the mount).

After configuring the mould parts, the laryngoscope (10) may be moulded, for example utilising an injection moulding process whereby the material of the body (12), for example polycarbonate, is injected in between the mould parts via a sprue (not shown) a runner (508) and/or a gate (510). It should be appreciated that other arrangements or configurations for injecting the material may also be used. A parting line (512) may be provided between the two main parts of the mould (502). The parting line (512) may be provided on the plane (46) shown in Figure 5, but the parting line may also deviate from this plane due to practical considerations. For example at the guideway (68), the parting line (512) may be curved away from the plane (46) in a direction towards the mount (64), to facilitate separation of the two main parts of the mould (502). After the injection of the material is finished, and the material has cooled down, the plurality of further mould parts (506, 507, 509) and the B-side may be removed and the laryngoscope may be removed from the A-side (504) (for example by means of ejector pins, as are known in the art), to yield the laryngoscope (10) shown in Figure 17, as a single part, or a part of unitary construction. The material of the body (12) formed at the sprue (508) and gate (510) may then removed, for example by machining.

Some of the finer details of the laryngoscope (see Figures 2, 3, 6 and 7 in this regard) have been omitted from Figures 16 and 17, however these finer details may also be formed during the moulding process (500). It is envisaged that the chamber (24) may alternatively be formed by utilising one of the at least two main parts (A-side (504) and B-side) of the mould, or by forming the chamber in the handle after the laryngoscope (10) has been moulded, by subtractive manufacturing such as machining, drilling or any other material-removing process. It should also be appreciated that embodiments of the laryngoscope (10) may be possible wherein the chamber (24) is in the form of a slot or other cavity formed in the handle (14).

After the body (12) of the laryngoscope is manufactured, the transmitting module (26) may be inserted into the chamber (24) and the camera (18) may be installed into the mount (64) to assemble the wireless laryngoscope. The cable (32) may be connected or coupled to the transmitting module (26) and to the camera (18) (arrangements where the camera, the light and the cable are pre-manufactured and assembled are also possible, for example when utilising a borescope). The cable (32) is also inserted or placed into the groove (56) and passed through the passage (63). The gripping formations (58) are arranged in a staggered fashion, to grip the cable firmly, so that it remains in the groove (56) during use of the laryngoscope (10). Referring again to Figures 5 to 8, a notch (94) may be provided in the rim (40) of the handle (14) to enable the cable (32) to pass through the notch and into the chamber (24). It is envisaged that the arrangement of the groove (56), the passage (63), and the notch (94) provides for a streamlined configuration which may enable the user (74) to move the laryngoscope (10) freely without being inhibited by tethered wires or bulky attached screens as is the case with prior art devices.

Embodiments are possible wherein the laryngoscope as described herein may be sterilised, disinfected, or otherwise cleaned, for example by irradiation and may be packaged in a sterilised or clean container. The laryngoscope may be provided in a hermetically sealed single-use package, such that the laryngoscope is intended for disposal after single use thereof. The single use package may have a line or region of weakness or frangible portion. The line of weakness or region of weakness, or the frangible portion may be damaged, broken or severed when the user opens the package. The package may be configured such that re-sealing thereof is inhibited or prevented. Moreover, the package or the laryngoscope itself may include markings indicating single use or a warning against reuse. The single-use package or kit may provide advantages over prior art laryngoscopes that the applicant is aware of. This may be particularly advantageous in environments where sophisticated, complex, or expensive reusable devices are not available or in limited supply, and where intubation is urgently required on an ad hoc basis. The package may be a flexible bag or a rigid container. The package may be made of plastics materials such as polymer-based plastics, thermoplastic polymers, polycarbonate, polyethylene terephthalate (PET), polypropylene (PP), low-density polyethylene (LDPE), polystyrene, vinyl etc.

Embodiments are possible wherein the battery or power source may also include a pull tab, or insulator which is removable or adjustable. The pull tab or insulator may be arranged such that the battery is activated upon removal of the pull tab or insulator, such that the battery provides power to the wireless transmitter, or to the transmitting module. The pull tab or insulator may be provided instead of the button (shown in Figure 8). The pull tab or insulator may for example be provided between terminals of the battery, such that the terminals are connected when the pull tab or insulator is removed. The battery and/or wireless transmitter may be permanently embedded or enclosed in the body of the laryngoscope, or in the compartment or chamber (for example by using a permanent adhesive, seal or a permanent or rigid lid for the compartment). The pull tab or insulator may extend through an aperture in the body to be removed or adjusted from externally of the body which may activate the wireless transmitter and/or camera of the laryngoscope. The battery may be arranged to provide power to the wireless transmitter only for a limited time, or only until the battery is depleted, such that the laryngoscope is intended for disposal after single use thereof. The limited time may be selected as required, but it is envisaged that the limited time may be about an hour, 2 hours, or between 1 and 3 hours. Of course, longer or shorter time periods may also be selected, such as about 30 minutes or even 4 hours or more. The wireless transmitter may be arranged to automatically pair with the mobile device once the battery is activated (when the pull tab or insulator is adjusted or removed), and to continue to transmit images or video recorded by the camera for a limited time. The battery and wireless transmitter (and/or other components of the laryngoscope such as the cable and camera) may be embedded or encapsulated in the body, such that the user is inhibited from accessing these components. This may facilitate non-reusability, or single use of the laryngoscope, or may enable the laryngoscope to be intended for single use. Alternatively, instead of using the pull-tab or insulator, the battery or transmitting module may be configured such that the transmitting module may be switched on by the button or other switch, and then the transmitting module may be configured to automatically shut down, or to deactivate after a limited amount of time, to inhibit reuse of the laryngoscope. The transmitting module may include a computing device which may for example include a processor and a timer or timing component to facilitate this automatic shutdown process. The computing device may also include a memory and the processor may facilitate wireless communication between the transmitting module and the mobile device.

It will be appreciated that the laryngoscope and its method of manufacture may provide a single use or disposable product which may be available at a lower price than previously available devices. As mentioned earlier in this specification, the invention extends to other forms of endoscopy and is not limited to the laryngoscope depicted in the accompanying representations. The endoscope or laryngoscope disclosed herein may be used on any mammal and it is also envisaged that animals may be intubated and/or endoscopy may be performed on animals or humans. For example, artificial insemination of mammals may be facilitated, or the endoscope may be used to perform other types of endoscopy such as, but not limited to, gastroscopy, Esophagogastroduodenoscopy (EGD), Oesophagogastroduodenoscopy (EGD or OGD) also called Panendoscopy (PES), and upper gastrointestinal (Gl) endoscopy. The inverted Z-shaped cross section depicted may be at least partially inverted Z-shaped or may be at least partially Z-shaped. Laryngoscopy is performed on the patient depicted in the accompanying representations, with the patient lying flat on his or her back, but the laryngoscope may also be utilised in other positions for example with the patient in a sitting position, such as after a motor vehicle accident. It is envisaged that the laryngoscope disclosed herein enables the user to perform laryngoscopy in situations where time is of the essence, for example during an asthma attack, in a vehicle accident scenario, and when the patient has a difficult anatomy (having a large neck and/or chest, or having restricted neck movement). The laryngoscope may be inserted without requiring a backwards bend of the patient’s neck. This may be facilitated by the first section and second section being angled relative to each other. The features of the section of substantially straight tube that has the second axis for holding the camera therein aligned with the second axis may also facilitate intubation where the patient’s neck is straight or when the patient’s body has abnormal anatomy. Moreover, the camera observing a field of view at the tip of the insertion member, and the insertion member being angled or curved from the first axis at the handle to the second axis towards the tip, through a total angle of more than 100 degrees may facilitate these types of intubation procedures.

It should also be appreciated that the laryngoscope or endoscope disclosed may be compatible with any mobile device which may be available at the time when intubation is required. A further mount near the handle may in some circumstances be provided for the mobile device, or the mobile device may be mounted, placed or held elsewhere that is convenient to the user. The streamlined design between the cable and the body of the laryngoscope may also facilitate insertion and use. The wedge is in the drawings depicted as being formed by the width of the insertion member decreasing towards the tip relative to the plane, but the width of the insertion member may also decrease relative to other planes. The wedge provides a user with the functionality of prying apart the teeth of the patient without requiring an additional device, which may be useful especially when the patient’s jaw is clinched for some reason.

It will further be appreciated that the endoscope or laryngoscope disclosed herein may, as an alternative to injection moulding, also be made by a manufacturing method such as an additive manufacturing method (for example utilising one of the 3D printing technologies), or a subtractive manufacturing method (for example machining or other material-removing processes), or a combination of these methods. The body of the endoscope may be made of a material comprising one of a polymer, a plastic and a polycarbonate or of other rigid materials. The material may be recyclable. The foregoing description has been presented for the purpose of illustration; it is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Persons skilled in the relevant art can appreciate that many modifications and variations are possible in light of the above disclosure.

Any of the steps, operations, components or processes described herein may be performed or implemented with one or more hardware or software units, alone or in combination with other devices. In one embodiment, a software unit may be implemented with a computer program product comprising a non-transient computer-readable medium containing computer program code, which can be executed by a processor for performing any or all of the steps, operations, or processes described. Software units or functions described in this application may be implemented as computer program code using any suitable computer language such as, for example, Java™, C++, or Perl™ using, for example, conventional or object-oriented techniques. The computer program code may be stored as a series of instructions, or commands on a non- transitory computer-readable medium, such as a random access memory (RAM), a read-only memory (ROM), a magnetic medium such as a hard-drive, or an optical medium such as a CD- ROM. Any such computer-readable medium may also reside on or within a single computational apparatus, and may be present on or within different computational apparatuses within a system or network. Flowchart illustrations and/or block diagrams of methods, systems, and computer program products according to embodiments are used herein. Each block of the flowchart illustrations and/or block diagrams, and combinations of blocks in the flowchart illustrations and/or block diagrams, may provide functions which may be implemented by computer readable program instructions. In some alternative implementations, the functions identified by the blocks may take place in a different order to that shown in the flowchart illustrations.

The language used in the specification has been principally selected for readability and instructional purposes, and it may not have been selected to delineate or circumscribe the inventive subject matter. It is therefore intended that the scope of the invention be limited not by this detailed description, but rather by any claims that issue on an application based hereon. Accordingly, the disclosure of the embodiments of the invention is intended to be illustrative, but not limiting, of the scope of the invention, which is set forth in the following claims. Throughout the specification and claims unless the contents requires otherwise the word ‘comprise’ or variations such as‘comprises’ or‘comprising’ will be understood to imply the inclusion of a stated integer or group of integers but not the exclusion of any other integer or group of integers.

Claims

CLAIMS:

1 . A wireless laryngoscope comprising a body formed as a single part, the single part including a handle extending along a first axis and having a compartment therein, a curved or angled insertion member extending from the handle towards a tip, a mount for a camera located towards the tip, and a guide for a cable that extends between the mount and the compartment, wherein the compartment houses a power source and a wireless transmitter for transmitting digital images or video recorded by the camera, and wherein the camera mount includes a section of substantially straight tube that has a second axis for holding the camera therein aligned with the second axis so that the camera observes a field of view at the tip of the insertion member, the insertion member being angled or curved from the first axis at the handle to the second axis towards the tip, through a total angle of more than 100 degrees.

2. The wireless laryngoscope as claimed in claim 1 , wherein the single part is made from injection-moulded plastics.

3. The wireless laryngoscope as claimed in claim 1 or claim 2, wherein the insertion member is angled or curved from the first axis to the second axis through a total angle of between 100 and 135 degrees.

4. The wireless laryngoscope as claimed in any one of the preceding claims, wherein the insertion member has uneven sides with protruding or recessed structures which become fouled during use, to thereby dissuade a user from cleaning the laryngoscope for reuse.

5. The wireless laryngoscope as claimed in any one of the preceding claims, wherein the laryngoscope is provided in a hermetically sealed single-use package, such that the laryngoscope is intended for disposal after single use thereof.

6. The wireless laryngoscope as claimed in any one of the preceding claims, wherein the guide is formed at least partially by a groove along an outer surface of the handle for receiving the cable and wherein the groove includes gripping formations for gripping the cable when it is inserted into the guide.

7. The wireless laryngoscope as claimed in any one of the preceding claims, wherein the handle has a base at one end of the handle which is furthest from the tip, and wherein the base at least partially defines a flat surface extending along a plane that is angled between 30 and 60 degrees from the first axis.

8. The wireless laryngoscope as claimed in any one of the preceding claims, wherein the insertion member has a portion along its length adjacent the handle that defines a first section and a subsequent portion along its length that defines a second section, wherein the first section and second section are angled relative to each other and wherein the second section includes the mount for holding the camera.

9. The wireless laryngoscope as claimed in any one of the preceding claims, wherein a cross section of the insertion member is at least partially Z-shaped, or at least partially inverted Z-shaped, so as to enable the laryngoscope to operatively apply pressure to soft tissue with one side of the cross section while enabling an intubation member to pass on the other side of the cross section.

10. The wireless laryngoscope as claimed in any one of the preceding claims, wherein the body is elongate and extends in a plane and has a width perpendicular to that plane, the width of the insertion member decreasing towards its tip so as to form a wedge adjacent the tip.

1 1. The wireless laryngoscope as claimed in any one of the preceding claims, wherein the wireless transmitter is configured to transmit the images recorded by the camera to a mobile device.

12. A system including a wireless laryngoscope as claimed in any one of the preceding claims, and a mobile device in wireless data communication with the laryngoscope, the mobile device having a display which is operable to display images or video recorded by the camera.

13. The system as claimed in claim 12, wherein the system includes a central server in data communication with the mobile device and wherein a purpose-created mobile application is downloadable and installable on the mobile device to facilitate operation of the system.

14. The system as claimed in claim 13, wherein the system includes a remote supervision station in data communication with the server or with the mobile device, the remote supervision station including a supervision display configured to display the field of view of the camera in near real time, to enable a remote supervisor to provide remote assistance to a user of the laryngoscope.

15. A method of manufacturing a body of a wireless laryngoscope as claimed in any one of claims 1 to 1 1 , the method comprising: providing a first main mould and an opposite second main mould, the first and second main moulds when connected defining a cavity to form the laryngoscope as a single part including the handle, the insertion member and the mount for the camera; placing a first mould insert into the cavity between the first and second moulds, the first mould insert defining the compartment in the handle; placing a second mould insert into the cavity between the first and second moulds, the second mould insert defining the section of substantially straight tube of the mount; and injection moulding the laryngoscope by filling the voids between the first and second moulds with plastics material.