WO2018002858A1

WO2018002858A1 - Laryngoscope

Info

Publication number: WO2018002858A1
Application number: PCT/IB2017/053894
Authority: WO
Inventors: José Fernando ARANGO ARAMBULO; Juan Felipe ISAZA SALDARRIAGA; Helmut TREFFTZ GOMEZ; Christian Andrés DIAZ LEON; David CARMONA ZAPATA; Tatiana SIERRA MONTOYA
Original assignee: Universidad Eafit; Universidad Ces; Hospital Pablo Tobon Uribe
Priority date: 2016-06-29
Filing date: 2017-06-29
Publication date: 2018-01-04
Also published as: BR112018077200A2; PE20190465A1; CL2018003836A1; ECSP19003153A; CO2016173659A1

Abstract

The present invention corresponds to a device for performing intubation procedures. The device comprises a grip handle, a channel and a blade. The shape of the grip handle is defined by the sweeping motion of a rectangular cross-section in a specific trajectory. The trajectory is defined by a first straight segment with a length of 10 cm, a second straight segment with a length of 4.2 cm, a third curved segment with an arc length of 2.7 cm and a radius of 2.8 cm, and a fourth straight segment with a length of 3.1 cm. The second segment is connected to the first segment at an angle measuring 172°. The third segment is connected to the second segment. And the fourth segment is connected to the third segment such that the angle between the second segment and the fourth segment is 135°. The fourth segment comprises a bottom edge and a top edge. The channel runs along the trajectory of the grip handle, in one of the walls of the grip handle such that the channel is open. The blade attached to the bottom edge of the fourth segment. The blade is positioned at an angle α between 5° and 34° in relation to the bottom edge.

Description

LARYNGOSCOPE

Field of the Invention The present invention relates to a medical device for manipulating the airway during tracheal intubation and similar procedures. Specifically, this invention relates to medical devices known as laryngoscopes.

Description of the Prior Art

Since the 1940s, different devices have been used to perform tracheal intubations. These devices are commonly designed with a grip handle and a blade, as well as a light at its tip, which is inserted into the oral cavity to allow for direct visualization of the vocal folds in order to insert a tube therethrough. These devices are widely available at all levels of care and are safe when used appropriately. However, they demand a steep learning curve, since 15 to 30 intubations in real cases are required to achieve proper performance of the procedure (90% success rate), and they also demand continuous practice to maintain this rate of success. Furthermore, even highly qualified personnel, such as anesthesiologists, deal with difficult cases where manipulation of the airway is made more difficult by congenital anatomical abnormalities or maxillofacial trauma. In these cases, conventional laryngoscopy or intubation using available equipment is typically very complicated. Since the 1980s, several types of laryngoscopes that incorporate newly shaped designs and have the shared feature of providing enlarged video images have been in development. These video-assisted laryngoscopes have proven their utility in improving glottic visualization in real and simulated environments involving airways (due to trauma or congenital abnormalities), with a greater frequency of successful intubations and a greater success rate in the first intubation attempt, with no difference in the amount of time required to succeed and without increasing the rate of lip, gum and tooth trauma or posterior pharyngeal pain. In addition to improving the visualization of the various anatomical structures, these new technologies also require less training. Their learning curve is not as steep, and they do not increase the complications due to use thereof and allow for visualization by personnel outside of the procedure.

Some devices, such as Airtraq (PRODOL MEDITEC S.A, htfp://ww .airtraq .com) available in different sizes, allow for visualization of the glottis without the need to align the oral, pharyngeal and laryngeal axes, which allows for intubation with only minimal head manipulation. This device operates by means of a light source, an anatomical plate and a handle. The images are transmitted by means of a series of lenses to the handle, where the images may be visualized or it may be connected to a camera to be visualized on a monitor.

The Pentax AWS video-laryngoscope (manufactured by AMBU, htt : /^'/www . ambit . com/) is composed of an anatomical handle and a disposable blade that attaches to the handle. This blade allows for the passage of the tracheal tube. Inside the handle and as far as its tip, there is a LED light and an optical device that transmits the image toward a small screen attached to the grip handle. The McGrath video-laryngoscope (www.aircraftmedical.com) shares features with the previous devices, namely, a light source, a grip handle, and a lighting and optical device at its tip. The difference from the previous devices lies in the blade that is inserted in the oral cavity in order to visualize the glottis. The blade has the same shape as the Magill blade, that is to say, it is not anatomical, because the alignment of the axes that make up the airway (oral, pharyngeal, laryngeal) must be performed by means of external manipulation or extension of the head, which makes the process more difficult and results in a steeper learning curve.

Despite the major advances made in these devices, the handling thereof presents difficulties when the device is inserted and the view of the vocal folds is not aligned with the service channel of the tracheal tube. This entails an increase in time required for intubation, which leads to desaturation or decrease in the blood oxygen content of the patient. Another drawback of the above devices is the inability to visualize the vocal folds due to obstruction by the epiglottis, which poses a risk of trauma for the vocal folds and is a drawback during the intubation process. Brief description of the invention

The present invention corresponds to a device for performing intubation procedures. The device comprises a grip handle, a channel and a blade. The shape of the grip handle is defined by the sweeping motion of a rectangular cross- section in a specific trajectory. The trajectory is defined by a first straight segment with a length of 10 cm, a second straight segment with a length of 4.2 cm, a third curved segment with an arc length of 2.7 cm and a radius of 2.8 cm, and a fourth straight segment with a length of 3.1 cm. The second segment is connected to the first segment at an angle β measuring 172°. The third segment is connected to the second segment. And the fourth segment is connected to the third segment such that the angle Θ between the second segment and the fourth segment is 135°. The fourth segment comprises a bottom edge and a top edge. The rectangular cross-section has rounded edges. The channel runs along the trajectory of the grip handle, in one of the walls of the grip handle such that the channel is open.

The blade is attached to the bottom edge of the fourth segment. The blade is positioned at an angle a between 5° and 34° in relation to the bottom edge.

In one embodiment of the invention, the device comprises a visualization mechanism composed of a visualizer and lightning means. The visualizer is placed on the fourth segment. The lighting means illuminates a spatial range. In one embodiment of the invention, the device comprises two channels, one in each lateral wall of the grip handle. In one embodiment of the invention, the blade is pivotable. In this embodiment, the device comprises two pivot joints, one lever and one transmission. The blade is attached to the fourth segment by means of a pivot joint. The lever is attached to the first segment by means of a pivot joint. And the transmission connects the lever and the blade such that when the lever is pivoted, the movement is transmitted by the transmission, causing the blade to pivot.

Brief description of the figures FIG. 1A and IB depict one embodiment of the invention that comprises a channel, a visualization mechanism and a blade. FIG. 1A is a frontal perspective view of the invention. FIG. IB is a lateral view of the invention.

FIG. 2A and 2B depict another embodiment of the invention that comprises two channels, a visualization mechanism and a blade. FIG. 2A is a frontal perspective view of the invention. FIG. 2B is a frontal view of the invention.

FIG. 3A and 3B depict another embodiment of the invention that comprises a channel, a visualization mechanism and a pivotable blade. FIG. 3 A is a left frontal perspective view of the invention. FIG. 3B is a right frontal perspective view of the invention.

Detailed description of the invention

The present invention corresponds to a device for performing intubation procedures (hereinafter 'the device'), belonging to the class known as laryngoscopes and video- laryngoscopes.

Referring to FIG. 1A and FIG. IB, the device comprises a grip handle (1), a channel (2) and a blade (3). The shape of the grip handle (1) is geometrically defined by a sweeping motion, which requires a cross-section and a trajectory line. The rectangular cross-section has rounded edges. The trajectory line is defined by the following segments: - a first straight segment (4) with a length of 10 cm;

- a second straight segment (5) with a length of 4.2 cm;

- a third curved segment (6) with an arc length of 2.7 cm and a radius of 2.8 cm; and

- a fourth straight segment (7) with a length of 3.1 cm. The first segment (4) is connected to the second segment (5) at an angle measuring 172°. The second segment (5) is connected to the third segment (6). At the other end of the third segment (6), the fourth segment (7) is connected such that the angle between the second (5) segment and the fourth segment (6) is 135°. The fourth segment (7) has a top edge (17) and a bottom edge (8) that are parallel, and that correspond to the wide side of the rectangular cross-section

Referring to FIG. 1A and FIG. IB, the blade (3) is connected to the fourth segment (7) at the opposite end of the third segment (6). Specifically, the blade (3) is connected to the bottom edge (8) of the fourth segment (7), forming an angle a between 5° and 34°. Angle a is measured in relation to the bottom edge (8) of the fourth segment (7).

In one embodiment of the invention, the angle a is 5°.

Referring to FIG. 1A and FIG. IB, the blade (3) is a rectangular plate, that is connected to the fourth segment (7), at the bottom edge (8) of the fourth segment (7). The peripheral edges of the blade (3) are rounded. The free end of the blade (3) has a rounded tip (9).

The top edge (17) of the fourth segment (7) has a rounded fin (16), parallel to the blade (3). The function of the fin (16) is to separate the tissues of the pharynx during intubation, clearing the path to be followed by the endotracheal tube, and visualization of the structures that compose the airway, a condition that is required for the device that comprises visualization mechanisms (the latter is described hereinafter).

Referring to FIG. 1A and FIG. IB, the channel (2) runs along the trajectory of the grip handle (1). The path for the channel (2) is made in one of the lateral walls of the grip handle (1) such that the channel (2) is open. That is, the channel (2) does not correspond to a closed boundary. An endotracheal tube is guided through the channel (2), which is removed from the device by extracting it from the open side of the channel (2). Likewise, an endotracheal tube guide, also known as a tube exchanger, or a secretion aspiration tube, can be provided through the channel (2).

Referring to FIG. 2B, in one embodiment of the invention, the device comprises two channels (2), one channel (2) in each lateral wall of the grip handle (1). In this embodiment, the intubation guide is placed in whatever channel (2) preferred by the user of the device.

For the purposes of the present invention, "difficult airway procedures" shall be understood to mean procedures wherein the airway is totally or partially obstructed due to foreign objects, congenital abnormalities, or an accident. Under these conditions, placement of an endotracheal tube guide in the channel (2) is common.

Referring to FIG. 1A and FIG. IB and FIG. 2A and FIG. 2B, in one embodiment of the invention, the device comprises a visualization mechanism. The visualization mechanism is composed of a visualizer (10) and lighting means (11). The visualization means is placed on the fourth segment such that both the blade (3) and the surroundings with which the blade (3) interacts are visualized. The visualizer (10) captures images, and the lighting means (11) illuminate the spatial range of the images captured by the visualizer (10). The visualizer (10) is selected from the group consisting of video cameras, arrangements of lenses, fiber optics, still cameras or a combination thereof. In one embodiment of the invention (not shown), the visualization mechanism comprises a screen in which the images captured by the visualizer (10) can be visualized, accordingly, the screen is operationally connected to the visualizer (10). The screen is placed on the first segment (4).

In one embodiment of the invention (not shown), the visualization mechanism is connected to an external device, to which it transfers the images captured by the visualizer (10). The external device can be a screen, an image processor, a processing unit, and the like. In this embodiment, the visualizer (10) can be connected to the external device by means of wired or wireless connections.

In one embodiment of the invention, the visualizer (10) is a 1.3MP 1/12" VGA CMO camera. In one embodiment of the invention, the light (11) is four LED lights.

In one embodiment of the invention comprising a channel (2) and a visualization mechanism, the dimensions of the cross-section of the grip handle (1) are 22mm wide and 17mm high. In a preferred embodiment, the dimensions of the cross-section of the grip handle (1) at the first segment (4) are 24 mm in width and 17 mm in height. The above dimensions for the first segment (4) allow for an ergonomic grip of the device by the user.

In one embodiment of the invention, referring to FIG. 2A and FIG. 2B, the device comprises two channels (2) and a visualization mechanism. The dimensions of the cross-section of the grip handle (1) are 30 mm in width and 22 mm in height at the second segment (5), the third segment (6) and the fourth segment (7). At the first segment (4), the dimensions of the cross-section of the grip handle (1) are 30 mm in width and 19 mm in height, which allows for an ergonomic grip of the device by a user. One of the channels (2) is placed on the right side and the other on the left side of the visualizer (10). In this embodiment, the channels (2) have a diameter less than or equal to 3.8 mm, which allows for the intubation tube guides to pass. These dimensions facilitate the entry of the device into the patient and permits access through difficult airways. Furthermore, this embodiment allow for an intubation guide to be placed in one channel (2), and for a secretion aspiration tube to be placed in the other channel (2); in this way, the user of the device reduces the intubation process by one step by inserting the intubation guide and the secretion aspiration tube in the same step.

The embodiment comprising two channels (2) allows the user to select their preferred channel (2). In one embodiment of the invention, referring to FIG. 3A and FIG. 3B, the blade (3) is pivotable. In this embodiment, the device comprises:

- a lever (12);

- two pivot joints (13); and

- a transmission (14).

Referring to FIG. 3A and FIG. 3B, the blade (3) is connected to the fourth segment (7) by means of a pivot joint (13, such that the blade (3) pivots with respect to the pivot joint (13).

Referring to FIG. 3A and FIG. 3B, the lever (12) is attached to the first segment (4) by means of a pivot joint (13). In the preferred embodiment of the invention, referring to FIG. 3B, the lever (12) is placed on the internal side (15) of the first segment (4) of the grip handle (1). The aforementioned placement of the lever (12) is ergonomic for the user during operation of the device, since it allows for the lever (12) to be pivoted using fingers.

Referring to FIG. 3A, the transmission (14) connects the lever (12) and the blade (3) such that when the lever (12) is pivoted, the movement is transmitted by the transmission (14), causing the blade (3) to pivot. In this embodiment of the invention, the transmission (14) corresponds to a rigid element that is attached to the lever (12) by means of a pivot joint (13), and causes joint movement of the blade (3). In another embodiment of the invention (not shown), the transmission (14) can be a cable operationally connected to pivot the blade (3). In this embodiment, the cable slides within a channel made along the inside of the grip handle (1).

In another embodiment of the invention (not shown), the transmission (14) can be a gear wheel transmission operationally connected to pivot the blade (3).

The configuration of the grip handle (1) exhibits a 135° angle between the second segment (5) and the fourth segment (7). Due to the above, the device exhibits an anatomical geometry that allows for the alignment of the airway axes without the need for head manipulation.

The embodiment of the invention comprising a pivotable blade (3) allows for the glottis to be moved, which causes the laryngeal vestibule to open and allows for visualization of the vocal folds and the trachea.

Referring to FIG. 1A and FIG. IB, a tab (18) is placed on the fourth segment (7). The tab (18) is placed on the lateral wall where the channel (2) is located, allowing for the channel (2) to be open. The function of the tab (18) is to direct the endotracheal tube to the line of sight of the visualizer (10).

It must be understood that the present invention is not restricted to the modalities described and exemplified herein, and the person having ordinary skill in the art would understand that many other possible variations and modifications can be implemented which do not deviate from the spirit of the invention, which is only defined by the following claims.

Claims

1. A device for performing intubation procedures, comprising;

- a grip handle whose shape is defined by the sweeping motion of a rectangular cross- section in a specific trajectory, composed of:

- a first straight segment with a length of 10 cm;

- a second straight segment with a length of 4.2 cm, the second segment is connected to the first segment at an angle β measuring 172°;

- a third curved segment with an arc length of 2.7 cm and a radius of 2.8 cm, the third segment is connected to the second segment;

- a fourth straight segment with a length of 3.1cm, the fourth segment is connected to the third segment such that the angle Θ between the second segment and the fourth segment is 135°, the fourth segment comprises a bottom edge and a top edge;

- a channel that runs along the trajectory of the grip handle, in one of the walls of the grip handle the channel is open;

- a blade connected to the bottom edge of the fourth segment, the blade is positioned at an angle a between 5° and 34° in relation to the bottom edge.

2. The device from Claim 1, comprising two channels, one channel in each lateral wall of the grip handle.

3. The device from Claim 1, comprising a visualization mechanism composed of:

- a visualizer placed on the fourth segment; and

- lighting means that illuminate a spatial range.

4. The device from Claim 3, comprising two channels, one on each side of the visualizer.

5. The device from Claim 3, characterized by the fact that the visualizer is selected from the group consisting of video cameras, arrangements of lenses, fiber optics, still cameras or a combination thereof.

6. The device from Claim 3, comprising a screen connected to the visualizer; the screen is placed on the first segment.

7. The device from Claim 3, characterized by the fact that the visualization mechanism is connected to an external device.

8. The device from Claim 3, characterized by the fact that the lighting means are LED lights.

9. The device from Claim 1, characterized by the fact that the blade is a rectangular plate with rounded peripheral edges, and a free end with a rounded tip.

10. The device from Claim 1, comprising:

- a pivot joint by means of which the blade is connected to the fourth segment;

- a lever attached to the first segment by means of a pivot joint; and

- a transmission that connects the lever and the blade such that when the lever is pivoted, the movement is transmitted by the transmission, causing the blade to pivot.

11. The device from Claim 10, characterized by the fact that the lever is placed on an internal side of the grip handle.

12. The device from Claim 10, characterized by the fact that the transmission is selected from the group consisting of rigid elements, cables, gear wheels, and a combination thereof.

13. The device from Claim 1, comprising a fin located at the top edge; the fin is rounded and parallel to the blade.

14. The device from Claim 1, comprising a tab placed on the fourth segment on the wall where the channel is located.

15. The device from Claim 1, characterized by the fact that the dimensions of the rectangular cross-section are:

- 22 mm wide and 17 mm high at the second segment, third segment and fourth segment; and

- 24 mm wide and 17 mm high at the first segment.

16. The device from Claim 4, characterized by the fact that the dimensions of the rectangular cross-section are:

- 30 mm wide and 22 mm high at the second segment, third segment and fourth segment; and

- 30 mm wide and 19 mm high at the first segment.