INTUBATION DEVICE AND SYSTEM

Abstract

The present invention relates to: a laryngoscopy system including a laryngoscope body and an image display module; an image display module for a laryngoscopy system; and a kit including an image display module and at least one laryngoscope body. The laryngoscope body has a handle portion and a blade portion, the blade portion having a distal end and a handle connection end and a blade body extending therebetween. The laryngoscope body further comprises an imaging component disposed on or housed by the blade portion. The image display module is configured to receive image data from the imaging component, and includes an accelerometer for motion input control of the image display module.

Claims

1. A laryngoscopy system comprising: a laryngoscope body having a handle portion and a blade portion, the blade portion having a distal end and a handle connection end and a blade body extending therebetween, the laryngoscope body further comprising an imaging component disposed on or housed by the blade portion; and an image display module configured to receive image data from the imaging component; wherein the image display module includes an accelerometer for motion input control of the image display module.

2. A laryngoscopy system according to claim 1 wherein the operational status of the image display module is controllable based on motion detection by the accelerometer.

3. A laryngoscopy system according to claim 1 wherein the image display module and/or the laryngoscope body has no external buttons, switches or dials.

4. A laryngoscopy system according to claim 1 wherein the image display module comprises an integral power source, optionally wherein the integral power source is non-removable.

5. A laryngoscopy system according to claim 1 wherein the integral power source of the image display module is the sole power source for the laryngoscopy system.

6. A laryngoscopy system according to claim 1 wherein the image display module has an ingress protection rating as defined in international standard IEC 60529 of IP64 or higher.

7. A laryngoscopy system according to claim 1 wherein the image display module is pivotably mounted on the handle portion of the laryngoscope body, optionally through a pivot hinge.

8. A laryngoscopy system according to claim 1 wherein the image display module is removably mountable on the handle portion of the laryngoscope body.

9. A laryngoscopy system according to claim 1 wherein the image display module is mounted to the handle by corresponding male and female electrical connectors, optionally wherein the electrical connectors are corresponding male and female USB connectors.

10. A laryngoscopy system according to claim 1 wherein the laryngoscope body comprises a light emitting component disposed on or housed by the blade portion.

11. A laryngoscopy system according to claim 1 wherein the field of view of the imaging component includes part of the blade portion of the laryngoscope body.

12. A laryngoscopy system according to claim 1 wherein the imaging component is a camera disposed within a housing section of the blade portion of the laryngoscope body.

13. A laryngoscopy system according to claim 1 wherein the blade body has a locally narrowed portion disposed adjacent the handle connection end of the blade, the lateral extent of the locally narrowed portion being less than 60% of the maximum lateral extent of the blade body.

14. A laryngoscopy system according to claim 13 wherein the locally narrowed portion is formed asymmetrically with respect to the longitudinal axis of the blade body.

15. A laryngoscopy system according to claim 13 wherein the length of the locally narrowed portion is in a range from 1 cm to 5 cm in length.

16. A laryngoscopy system according to claim 1 wherein an upper side of the blade body defines a generally longitudinally arcuate surface, and at least a portion of the surface subtending an angle of at least 30° has a constant radius of curvature.

17. A laryngoscopy system according to claim 16 wherein the portion of constant radius of curvature is located towards the distal end of the blade.

18. (canceled)

19. A laryngoscopy system according to claim 1 wherein the image display module is configured to engage with the handle portion of the laryngoscope body such that a median plane of a screen portion of the image display intersects with a longitudinal central portion of the blade body of the laryngoscope.

20. An image display module configured for engagement with a laryngoscope body comprising an imaging component to thereby form a laryngoscopy system; wherein the image display module is configured to receive image data from the imaging component of the laryngoscope body when engaged with the laryngoscope body; and wherein the image display module comprises an accelerometer for motion input control of the image display module screen.

21. A kit comprising an image display module according to claim 20 and at least one laryngoscope body, the laryngoscope body having a handle portion and a blade portion, the blade portion having a distal end and a handle connection end and a blade body extending therebetween, the laryngoscope body further comprising an imaging component and a light emitting component disposed on or housed by the blade portion.

22. (canceled)

Description

SUMMARY OF THE FIGURES

[0061] Embodiments and experiments illustrating the principles of the invention will now be discussed with reference to the accompanying figures in which:

[0062] FIG. 1 shows a rear view line drawing of a laryngoscopy system according to the present invention, with the image display module shown in a detached configuration.

[0063] FIG. 2 shows a front view line drawing of the laryngoscopy system of FIG. 1, with the image display module shown in an attached configuration.

[0064] FIG. 3 shows a partial cutaway line drawing of the laryngoscopy system of FIGS. 1 and 2, showing an internal wiring configuration of the laryngoscope body.

[0065] FIG. 4 shows a side view line drawing of a laryngoscopy system according to the present invention, demonstrating range of movement of the image display module relative to the laryngoscope body.

[0066] FIG. 5 shows a side view line drawing of a laryngoscopy system according to the present invention, demonstrating constant radius of curvature of a portion of the blade body.

[0067] FIG. 6 shows a bottom view line drawing of a blade body having a locally narrowed portion.

[0068] FIG. 7 shows a schematic drawing of a kit according to the present invention.

[0069] FIG. 8 shows a schematic drawing of a laryngoscopy system according to the present invention in use.

DETAILED DESCRIPTION OF THE INVENTION

[0070] Aspects and embodiments of the present invention will now be discussed with reference to the accompanying figures. Further aspects and embodiments will be apparent to those skilled in the art. All documents mentioned in this text are incorporated herein by reference.

[0071] FIG. 1 and FIG. 2 show front and rear views of a laryngoscopy system 100 according to the present invention. The laryngoscopy system 100 includes a laryngoscope body 1 and an image display module 3, each of which will be described in detail below. The laryngoscope body 3 and the image display module are interengageable to form a single unit. In FIG. 1, the image display module is shown in a detached configuration. In FIG. 2, the image display module is shown in an attached configuration.

[0072] The laryngoscope body 3 comprises a handle portion 5 and a blade portion 7, the blade portion having a distal end 9 (also referred to herein as a front, or tip end) and a handle connection end 11 (also referred to herein as a rear end) and a blade body extending therebetween. The blade body has an underside 13 and an upper side 15, these being used in relation to the blade as oriented in use: with the handle vertical and blade body affixed to the downwards end of the handle, the blade projecting in the operating position.

[0073] The upper side 15 of the blade portion 7 comprises a generally arcuate surface, which, in use, engages with the patient's airway anatomy, as shown in FIG. 8 (discussed below). This arcuate surface is substantially flat in a transverse direction. The underside 13 of the blade comprises a housing portion 17 which houses one or more light emitting components 28 (here, LEDs) and one or more imaging components 29 (here, a 640×480 pixel CMOS camera sensor) at a distal end of the housing portion. The underside of the blade further comprises a laterally-directed guide face 19 for guiding intubation. This is conveniently formed in the present embodiment as a side wall of the housing portion 17.

[0074] The blade is conveniently formed from a cast or moulded zinc alloy, although the material of the blade is not particularly limited. The total vertical extent of the blade portion 7 at any one point measured along the longitudinal length of the blade between the underside and the upper side of the blade is 10 mm or less. This low vertical profile allows for greater freedom of movement during the intubation process given the limited space within which the clinician can work.

[0075] The handle portion 5 and the blade portion 7 are fixedly connected at the handle connection end 11 of the blade. The handle portion 5 is generally barrel-shaped, which allows for greater comfort during use. The handle portion 5 comprises a connection section 21 configured to provide a mechanical and electrical connection of the handle portion to the image display module 3. The connection section 21 includes a USB connector 23 arranged for connection with a corresponding USB connector port (not visible) on the image display module 3. Whilst in this arrangement, the USB connector on the handle is a ‘male’ USB connector configured to engage with a ‘female’ USB port on the image display module, it will be understood that an alternative configuration may be used in practice (e.g. provision of a ‘female’ USB port on the handle portion, and provision of a ‘male’ USB connector on the image display module, or provision of an alternative (non-USB) type of electrical connection).

[0076] The laryngoscope body 1 contains no internal power source. Rather, the sole power source of the laryngoscopy system is the internal battery of the image display module 3, which is a non-removable, rechargeable battery. All powered components which form part of the laryngoscopy body, for example the light emitting components 28, and the imaging component 29, are therefore powered by the image display module, e.g. via one or more internal wires. This arrangement reduces the weight of the laryngoscope body, and leads to reductions in the cost of manufacture of the laryngoscope body, which makes it suitable for use as a ‘single use’, or disposable component.

[0077] The image display module 3 comprises a module housing 25 and a screen 27. The image display module is configured to engage with the handle portion of the laryngoscope body such that a median plane of a screen portion of the image display (as indicated by line M.sub.1) is offset from a median plane of the handle portion (as indicated by line M.sub.2) of the laryngoscope body. This arrangement provides increase ease of manipulation of the laryngoscope in response to the observed video being displayed on the image display module.

[0078] The image display module has no external control members, i.e. no buttons, switches, dials formed on or disposed on an outer surface of the module. This allows for reduced contamination risk. The image display module does comprise an internal (recessed) device reset button 26, accessible via a pin-hole opening formed in the outer surface of the image display module. As discussed above, in some arrangements, the image display module may comprise a single external control member, such as an on/off power button, but such an arrangement is not shown in the figures.

[0079] The image display module includes an accelerometer (not shown) for motion input control of the image display module, in a manner discussed below. The image display module is configured to receive image data from the imaging component 29 disposed within the housing portion of the laryngoscope body. Conveniently, the image display module is configured to receive image data via one or more internal wires 31 disposed within the laryngoscope body, as shown in FIG. 3, which is a partial cutaway line drawing of the laryngoscopy system of FIGS. 1 and 2. Said internal wire(s) are connected at a first end to the imaging component 29, and connected at a second end to the USB connector 23. Image data can then be transferred to the image display module via the USB connection. It is also contemplated that in some arrangements, the image display module may be configured to receive image data by wireless transmission from the imaging component.

[0080] As shown in FIG. 4, the image display module 3 is, in this arrangement, pivotably mounted on the handle portion 5 of the laryngoscope body 1. The pivoting connection is provided by means of a pivot hinge 33 formed on the handle portion of the laryngoscope body, the connection section 21 of the handle portion being pivotable relative to the remainder of the handle portion. As the image display module is mounted to the connection section 21 of the handle portion, this therefore allows for pivoting of the image display module relating to the handle portion through an angle of x.sub.1°. A pivotable mounting provides advantages in terms of ease of use of the system, as a user of the device can adjust the angle of the image display module relative to the laryngoscope body to thereby select a comfortable viewing angle of the image display module during use.

[0081] Another aspect of the present invention relates to a laryngoscopy system in which an upper side of a blade body of the laryngoscope defines a generally longitudinally arcuate surface, and at least a portion of the surface has a constant radius of curvature. FIG. 5 shows a side view line drawing of a laryngoscopy system having such an arrangement. The constant radius of curvature is defined based on the upper side 15 of the blade body; that is, the upper side 15 of the blade body defines a generally longitudinally arcuate surface, and a portion of this surface subtending an angle of x.sub.2° has a constant radius of curvature. In this arrangement, x.sub.2 is about 65°, however the constant radius of curvature portion may subtend any angle between 30° up to 90° or more. Providing a blade with such a curvature can allow for ease of insertion of the laryngoscope blade to a patients airway during e.g. an intubation procedure.

[0082] Another aspect of the present invention relates to a laryngoscopy system in which the blade body of the laryngoscopy system has a locally narrowed portion disposed adjacent the handle connection end of the blade. FIG. 6 shows a bottom view line drawing of such a blade. The lateral extent of the locally narrowed portion 35 is less than 60% of the maximum lateral extent 37 of the blade body. In the arrangement shown here, the blade is asymmetrically narrowed such that the lateral extent of the locally narrowed portion is about 11 mm, and the maximum lateral extent of the blade body is about 25 mm. In this way, the lateral extent of the locally narrowed portion is about 44% of the maximum lateral extent of the blade body.

[0083] The length (L) of the locally narrowed portion is selected to allow for reduced impingement on a patient's teeth during intubation of the patient. This can reduce risk of damage to a patient's teeth during use of the laryngoscope, and furthermore provide greater range of movement for a user during an intubation procedure. The length of the locally narrowed portion is defined between first and second points at which the lateral extent of the blade is 60% or less of the maximum lateral extent, as indicated approximately by the two dotted lines in FIG. 6. In the arrangement shown, the length of the locally narrowed portion is approximately 30 mm.

[0084] Laryngoscopy systems according to the present invention may be provided in kit form. FIG. 7 shows a schematic drawing of a kit according to the present invention. The kit comprises a single image display module 3 (both sides of the image display module shown in FIG. 7), the image display module having features as described above. The kit further includes two laryngoscope bodies 1 which are provided in respective sealed and sterile containers 43a,b, the laryngoscope bodies having features as discussed above. Providing a kit in this manner means that a plurality of sterile laryngoscope bodies 1a, b can be used as single-use laryngoscope bodies, in combination with the single reusable and sterilisable image display module 3.

[0085] In the embodiment shown in FIG. 7, the kit further comprises a charging stand 45, configured to engage with the image display module to charge the internal battery of the image display module, a USB cable 47 and a mains power supply connector 49. The internal battery of the image display module can be charged or recharged by connection to an external power source, e.g. by engaging the image display module with the charging stand, and connecting the charging stand to a mains power supply using the mains power supply connector. It may be necessary to charge the image display module before first use, in particular in cases where the image display module is placed in a ‘hard off’ mode during manufacture. In such a case, the image display module may be configured to be placed in a standard operational mode upon connection to a power source for charging.

[0086] To ready the kit for use in a laryngoscopy procedure, an operator (e.g. a clinician) opens at least one of the sealed containers 43a, and extracts the laryngoscope body 1a, in sterile condition. The laryngoscope body is then connected to the image display module 3 by engagement of the USB connector on the laryngoscopy body with the cooperating USB port on the image display module, to provide a laryngoscopy system 100 ready for use in e.g. a tracheal intubation procedure as shown in FIG. 8.

[0087] As the image display module is picked up by the clinician, the accelerometer of the image display module detects this motion activity, thereby triggering the image display module to enter the active mode. Upon entering the active mode, the processor of the image display module sets a movement level threshold, and updates a system timer status to a predetermined time value of 60 seconds. When the image display module is in active mode, and connected to the laryngoscopy body, a screen portion of the image display module is configured to receive and display image data transmitted from the imaging component on the screen portion of the image display module for viewing by the clinician. Power is also supplied to the light emitting component (LED) at the distal end of the blade of the laryngoscopy body, to assist in visibility during the procedure.

[0088] To perform a tracheal intubation, the clinician (represented by the eye motif in FIG. 8) standing above/behind the head of a supine patient then holds the laryngoscopy system in one hand, blade-downwards with the blade underside 13 away from them, and an endotracheal tube (ET tube) in the other hand (not shown). The blade portion 7 of the laryngoscope body is then inserted into the patient's airway 40, and may be turned and/or lifted to move tissues such as the tongue and epiglottis out of the way, to provide an imaged line of sight along the patient's airway to the patient's vocal cords 41. This allows the clinician to visualise the ET tube as it is passed through the patient's vocal cords into the trachea.

[0089] During this procedure, the detected movement activity resulting from movement of the laryngoscopy system by the clinician will generally exceed the movement level threshold of the system, and thus the system will remain in an active mode throughout the procedure. The system timer status is also updated, each time the movement threshold is exceeded. If the system is moved continuously it will therefore remain active. If the system is unmoved, or the detected motion activity does not exceed the movement threshold for a time period of 60 seconds, the image display module is configured to fade the screen of the image display module to black for 5 seconds and then enter standby mode or sleep mode, in which the display of the image display module is turned off, and in which the processor of the image display module is not active, thereby preserving battery life of the system during periods of non-use.

[0090] After use, the laryngoscope body 1a will be contaminated. However, rather than subjecting these elements of the system to cleaning and attempting to sterilize them, they are disposed of after a single use. This allows these elements of the system to have a simpler structure than conventional reusable laryngoscope bodies, since they need not withstand repeated cleaning operations. The (reusable) image display module 3 can then be cleaned and/or sterilized for future use in a conventional manner.

[0091] The features disclosed in the foregoing description, or in the following claims, or in the accompanying drawings, expressed in their specific forms or in terms of a means for performing the disclosed function, or a method or process for obtaining the disclosed results, as appropriate, may, separately, or in any combination of such features, be utilised for realising the invention in diverse forms thereof.

[0092] While the invention has been described in conjunction with the exemplary embodiments described above, many equivalent modifications and variations will be apparent to those skilled in the art when given this disclosure. Accordingly, the exemplary embodiments of the invention set forth above are considered to be illustrative and not limiting. Various changes to the described embodiments may be made without departing from the spirit and scope of the invention.

[0093] For the avoidance of any doubt, any theoretical explanations provided herein are provided for the purposes of improving the understanding of a reader. The inventors do not wish to be bound by any of these theoretical explanations.

[0094] Any section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.

[0095] Throughout this specification, including the claims which follow, unless the context requires otherwise, the word “comprise” and “include”, and variations such as “comprises”, “comprising”, and “including” will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.

[0096] It must be noted that, as used in the specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” one particular value, and/or to “about” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by the use of the antecedent “about,” it will be understood that the particular value forms another embodiment. The term “about” in relation to a numerical value is optional and means for example+/−10%.