WO2010066001A1

WO2010066001A1 - Laryngeal hood

Info

Publication number: WO2010066001A1
Application number: PCT/AU2009/001601
Authority: WO
Inventors: Thomas Ernest Havas
Original assignee: Thomas Ernest Havas
Priority date: 2008-12-10
Filing date: 2009-12-09
Publication date: 2010-06-17

Abstract

A airway device (10), and method of use of the device (10), for use in the ventilation of a patient and/or facilitation of anaesthesia. The airway device (10) comprises a curved and/or flexible tubular member (11) comprising a proximal end (12), a distal end (13), an anterior surface portion (6) defining an inner curvature (5), a posterior surface portion (8) defining an outer curvature (7), and at least one lumen (14) extending from a proximal opening (15) to a distal opening (16). A hood member (17) can be positioned at or adjacent the distal end (13) and comprises a periphery defining an opening (30) in fluid communication with the distal opening (16) of the tubular member (11). The opening (30) of the hood member (17) can face in a direction away from the anterior surface portion (6) of the tubular member (11). The opening (30) can instead or as well define a notional plane (22) with this notional plane lying at an outside angle (α) to a line tangential to the inner curvature (5) of greater than 90°. The hood member can also be positionable in the supraglottic larynx of a patient.

Description

"Laryngeal hood"

Cross-Reference to Related Applications

The present application claims priority from Australian Provisional Application Nos 2008906389 and 2009900017, the contents of which are incorporated herein by reference.

Field of the Application

The present application relates in part to a device for use in the ventilation of a patient and/or facilitation of anaesthesia of a patient. A method for maintaining patency of the upper airway of a patient when required, such as during surgery, is also described.

Background Art

One type of device used in patient ventilation and the administration of anaesthetic gases is the endotracheal tube. The endotracheal tube is a type of airway catheter that is inserted in the trachea during endotracheal intubation to assure patency of the upper airway. Endotracheal tubes come in a variety of forms and sizes and in a typical procedure are inserted through the mouth and sometimes the nose of a patient.

One problem with use of such tubes is that the patient almost always requires muscle paralysis to allow insertion of the tube and during the time the tube is in place. This results in the patient being unable to protect themselves from airway soiling, whether it be gastro-oesophageal reflux or blood or saliva from a surgical field. Nasogastric tubes are used to provide suction aspiration. Such tubes are passed blindly through the nose and via the pharynx into the oesophagus and stomach to enable suction aspiration. The blind introduction often causes trauma to the nose (nasal septum or turbinates). The tube can also curl up in the mouth, inadvertently pass into the larynx or can damage the back of the larynx or the top of the oesophagus.

The endotracheal tube can comprise a flexible and/or curved tube having a proximal end and a distal end. The proximal end will often having a connector that is attachable to a ventilator device. An inflatable cuff is also typically provided on the tube at or near its distal end with a secondary tube extending back from the cuff for a length sufficient to ensure the proximal end of the secondary tube is outside the body during normal use.

A hand-held laryngoscope can be used to visualise the larynx with the endotracheal tube then advanced along the patient's airway until the distal end of the tube passes through the delicate tissues of the larynx. Once in position, the cuff is inflated to occlude the airway surrounding the tube with the result that there is no flow of air through the trachea other than that passing through the endotracheal tube.

Another device used for ventilating patients and administering anaesthetic gases is the laryngeal mask. One example of this device is described in US 4509514 (Brain) and describes a tube having an inflatable mask member at a distal end thereof that is shaped to conform and sit behind the larynx and to seal around the circumference of the laryngeal inlet.

Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is solely for the purpose of providing a context for the present invention. It is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed before the priority date of each claim of this application.

Summary

Throughout this specification the word "comprise", or variations such as

"comprises" or "comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

In a first aspect, the present application is directed to an airway device comprising: a curved and/or flexible tubular member comprising: a proximal end; a distal end; an anterior surface portion; a posterior surface portion; and at least one lumen extending from a proximal opening to a distal opening; and a hood member at or adjacent the distal end comprising a periphery defining an opening in fluid communication with said distal opening; wherein the opening of said hood member faces in a direction away from the anterior surface portion of the tubular member.

In a second aspect, the present invention is directed to an airway device comprising: a curved and/or flexible tubular member having an inner curvature and an outer curvature and comprising: a proximal end; a distal end; said inner curvature defined by an anterior surface portion; said outer curvature defined by a posterior surface portion; and at least one lumen extending from a proximal opening to a distal opening; and a hood member at or adjacent the distal end comprising a periphery defining an opening in fluid communication with said distal opening, at least a portion of the hood member opening having a notional plane; and wherein a line tangential to the inner curvature of the anterior surface portion at said distal end is at an outside angle to said notional plane, said outside angle being greater than 90°.

In a third aspect, the present application is directed to an airway device comprising: a curved and/or flexible tubular member comprising: a proximal end; a distal end; and at least one lumen extending from a proximal opening to a distal opening; and a hood member at or adjacent the distal end comprising a periphery defining an opening in fluid communication with said distal opening; wherein on appropriate placement of the device in an airway of a patient the hood member is positionable in the supraglottic larynx. In the first and second aspects, the hood member can be positionable in the supraglottic larynx of a patient on appropriate placement of the device in an airway of the patient.

In the first aspect, the tubular member can have an inner curvature defined by the anterior surface portion and an outer curvature defined by the posterior surface portion. A line tangential to the inner curvature of the anterior surface portion at the distal end of the tubular member can be at an outside angle to a notional plane defined by at least a portion of the hood member opening. The outside angle can be greater than 90°.

In the second aspect, the opening of said hood member can face in a direction away from the anterior surface portion of the tubular member.

In the third aspect, the tubular member can have an anterior surface portion and a posterior surface portion. The opening of the hood member in this aspect can face in a direction away from the anterior surface portion. In the third aspect, the tubular member can have an inner curvature defined by the anterior surface portion and an outer curvature defined by the posterior surface portion. A line tangential to the inner curvature of the anterior surface portion at the distal end of the tubular member can be at an outside angle to a notional plane defined by at least a portion of the hood member opening. The outside angle can be greater than 90°.

In the aspects, the proximal opening of the tubular member can be at the proximal end of the tubular member. In another embodiment, the distal opening of the tubular member can be at the distal end of the tubular member.

In one embodiment, the tubular member can be formed in a curved configuration. The curvature can at least in part be circular, elliptical, parabolic or hyperbolic or a combination of one or more such curvatures. From its proximal end to its distal end, the tubular member can define an arc of between about 110° and 170°, more preferably about 145°. The length can be between about 15cm and 25cm and can be dependent on the anatomy of the patient.

The tubular member can be semi-rigid. In one embodiment, the tubular member can preferentially retain the curved configuration on insertion into an airway. In another embodiment, the tubular member can be formed in a substantially straight configuration and be suitably flexible to adopt a curved configuration. In another embodiment, the tubular member can be formed of a resiliently flexible material that allows the tubular member to conform at least substantially to the anatomy of the airway of the patient on insertion.

In yet another embodiment, the tubular member can be circular in cross-section and have an inner wall defining the lumen having an inner diameter. The inner diameter can be between about 0.5cm and 1.5cm, more preferably between about 0.6cm and 1.2cm, and most preferably about lcm or 0.8cm, or in the case of a child about 0.6cm. The tubular member can have an outer diameter. The outer diameter can be between about 0.5cm and 2cm, more preferably between about 0.7cm and 1.7cm, most preferably about 1.09cm or 1.2cm, or in the case of a child about 0.75cm.

The tubular member can be formed of a polymeric material. In one embodiment, the polymeric material can be transparent or translucent. The polymeric material can be polyvinyl chloride. A range of indicia can be provided on the tubular member including information concerning dimensions of the tube, such as the inner and outer diameter and the length.

The hood member can be positioned at the distal end of the tubular member. The hood member can be removably or non-removably mounted to the tubular member. The hood member can be comprised of a mounting member that is mountable to the tubular member. The mounting member can have a proximal end and a distal end. A peripheral member can be positioned on the distal end of the mounting member and define the periphery of the hood member. The mounting member can be disposed at an oblique angle to the notional plane of said at least a portion of the opening of the hood member. In this regard, the distal end of the tubular member can be formed at an oblique angle to the axis of the tube adjacent the distal opening of the tube. The peripheral member can be comprised at least in part of an inflatable cuff. Still further, the cuff can define the entire periphery of the hood member.

The peripheral member of the hood member is preferably non-circular. In one embodiment, the peripheral member can be at least in part substantially elliptical. The peripheral member can have a curved posterior end portion and taper in width towards an anterior end. The anterior end can be blunt to ensure substantially non-traumatic placement of the hood member in the supraglottic larynx.

The hood member can be formed separately from the tubular member and mounted thereto. The hood member can be mounted using a suitable adhesive and/or through use of plastic welding or suitable joining techniques. In another member, the cuff can be formed separately to the mounting member and appropriately joined thereto. In another embodiment, the mounting member can be integrally formed on the tubular member and the cuff formed separately and appropriately joined to the mounting member.

The hood member can be formed of a polymeric and/or elastomeric material. In one embodiment, the hood member can be formed of a synthetic or natural rubber or a polyurethane. The material making up the hood member can be transparent or translucent.

The hood member can be provided in different sizes suitable for different anatomies, for example, adult males, adult females and children.

In one embodiment, suitable dimensions for the peripheral member for use in adult males can be as follows. The length of the peripheral member from the anterior end to the posterior end can be between about 3.5cm and 4cm, more preferably about 3.75cm. The inner dimension of the relatively long axis of the opening (i.e. the axis that extends from the anterior end to the posterior end) defined by the peripheral member can be between about 2.2cm and 2.8cm, more preferably about 2.5cm. The width of the peripheral member can be between about 2.2 and 2.8cm, more preferably about 2.5cm. The inner dimension of the relatively short axis of the opening (i.e. an axis at right angles to the relatively long axis) defined by the peripheral member can be between about 1.2cm and 1.8cm, more preferably about 1.5cm.

In one embodiment, suitable dimensions for the peripheral member for use in adult females can be as follows. The length of the peripheral member from the anterior end to the posterior end can be between about 2.7cm and 3.5cm, more preferably about 3cm. The inner dimension of the relatively long axis of the opening (i.e. the axis that extends from the anterior end to the posterior end) defined by the peripheral member can be between about 1.8cm and 2.2cm, more preferably about 2cm. The width of the peripheral member can be between about 1.8 and 2.2cm, more preferably about 2cm. The inner dimension of the relatively short axis of the opening (i.e. an axis at right angles to the relatively long axis) defined by the peripheral member can be between about lcm and 1.5cm, more preferably about 1.2cm.

In one embodiment, suitable dimensions for the peripheral member for use in children can be as follows. The length of the peripheral member from the anterior end to the posterior end can be between about 1.5cm and 2.5cm, more preferably about 1.8cm. The inner dimension of the relatively long axis of the opening (i.e. the axis that extends from the anterior end to the posterior end) defined by the peripheral member can be between about 0.8cm and 1.2cm, more preferably about lcm. The width of the peripheral member can be between about lcm and 1.5cm, more preferably about 1.2cm. The inner dimension of the relatively short axis of the opening (i.e. an axis at right angles to the relatively long axis) defined by the peripheral member can be between about 0.6cm and lcm, more preferably about 0.8cm.

Once the device is in the desired location in the airway, the cuff can be inflated using a fluid. The fluid can be air or other suitable gas. The fluid can be delivered to the cuff through an inflation tube. The inflation tube can have a distal end in fluid communication with the cuff and extend back to a proximal end having a connector port joined thereto. The connector port can have a Luer or Luer lock to allow appropriate connection of a syringe to the connector port and also comprise a nonreturn valve and an inflation indicator. In normal use, the inflation tube should have a length such that the proximal end is outside the patient's airway.

The inflation tube can be formed separately to the tubular member. In another embodiment, the inflation tube can for at least part of its length be joined to the tubular member or extend therethrough. In another embodiment, at least part of the inflation tube can comprise a second lumen formed in the tubular member. The inflation tube can have an outside diameter of between 0.15cm and 0.8cm, more preferably between about 0.2cm and 0.6cm. The inflation tube can be formed of a suitable plastics material, such as polyethylene, polypropylene or polyvinyl chloride. The volume of the inflatable cuff can be between 0.6ml and ImI, more preferably about 0.7ml or 0.75ml.

As defined herein, a line tangential to the inner curvature of the anterior surface portion at the distal end of the tubular member can be at an outside angle to the notional plane defined by said at least a portion of the hood member opening. The outside angle can be greater than 90°. In one embodiment, this angle can be between 90° and 170°, more preferably between about 130° and 160°, yet more preferably between about 140° and 160°, and still more preferably between about 145° and 155°.

In a further embodiment, a line tangential to the posterior surface portion at the distal end of the tubular member can be at an outside angle of greater than 90° to the notional plane defined by said at least a portion of the hood member opening. In one embodiment, this angle can be between 90° and 170°, more preferably between about 120° and 150°, yet more preferably between about 125° and 150°, and still more preferably between about 130° and 140°.

In yet another embodiment, the notional plane defined by said at least a portion of the opening of the periphery of the hood member can be at angle of between about 80° and 100°, more preferably about 90°, to a notional plane defined by the proximal opening of the tubular member.

In one embodiment, the notional plane of the hood member opening can be defined by the most distal surface of the inflatable cuff at the posterior and anterior ends of the cuff.

The proximal end of the tubular member can have a connector mounted thereto. The connector can be inserted into the proximal end of the tubular member. A ventilator or the like can then connected to the connector when required.

The device can further comprise a suction tube. The suction tube can have a lumen extending from a proximal end to a distal end. In one embodiment, the suction tube can be formed separately and mounted on the tubular member. In another embodiment, the suction tube can be formed integrally with the tubular member. The proximal end of the suction tube can be spaced distally from the proximal end of the tubular member by a distance of between about 2.5cm and 5cm, more preferably about 3cm. The distal end of the suction tube can be spaced proximally from the distal end of the tubular member by a distance between about 3cm and 8cm, more preferably about 5cm. The suction tube and/or the lumen of the suction tube can be circular in cross- section and have an inner diameter and an outer diameter. The inner diameter can be between about 0.3 and 0.5cm, more preferably about 0.4cm and the outer diameter can be between about 0.4 and 0.6cm, more preferably about 0.5cm. The suction tube can be formed of a suitable polymeric material, such as polyvinyl chloride.

The suction tube can be used either intermittently or continuously, following placement of the device, to withdraw matter from the pharynx/oesophagus of the patient.

In yet another embodiment of the above aspects, a suction guidance tube can be mounted to the posterior surface portion of the tubular member. The suction guidance tube can have a lumen extending from a proximal end to a distal end. In one embodiment, the suction guidance tube can be formed separately and mounted to the posterior surface portion of the tubular member. In another embodiment, the suction guidance tube can be formed integrally with the tubular member. The proximal end of the suction guidance tube can be spaced distally from the proximal end of the tubular member by a distance of between about 3cm and 6cm, more preferably about 4.5cm. The distal end of the suction guidance tube can be spaced proximally from the distal end of the tubular member by a distance between about 12cm and 18cm, more preferably about 14cm. The suction guidance tube and/or the lumen of the suction guidance tube can be circular in cross-section and have an inner diameter and an outer diameter. The inner diameter can be between about 0.3 and 0.5cm, more preferably about 0.4cm and the outer diameter can be between about 0.4 and 0.6cm, more preferably about 0.5cm. The suction guidance tube can be formed of a suitable polymeric material, such as polyvinyl chloride.

The position of the suction guidance tube can be such that it does not interfere with visualisation of the larynx at the time of intubation. A suction tube can be inserted into and through the suction guidance tube. The suction tube can comprise a French size 12 suction tube but other sizes can be envisaged. The suction tube can be used to facilitate entraining air to achieve a sump suction effect within the pharynx and/or the oesophagus. The suction tube can be used either intermittently or continuously, following placement of the device, to withdraw any gastro-oesophageal soiling or soiling from above from the pharynx/oesophagus of the patient thereby reducing or eliminating the risk of aspiration. While the device will be typically used for human patients, it will be appreciated that the device could be used, with suitable modification if necessary, on non-human patients requiring intubation.

According to a fourth aspect, the present application is directed to a method of intubating a patient comprising: advancing a device as defined herein into an airway of a patient; and positioning the hood member in the supraglottic larynx.

In this aspect, and where the hood member has a peripheral member having an inflatable cuff, the method can further comprise inflating the cuff to seal the patient's airway around the periphery of the hood member.

The use and positioning of the device does allow, if desired, the device to be left in place when the patient is aroused and/or transported to a recovery ward. Still further, the proposed position and dimensions of the hood member as defined herein allows the hood member to be stabilised in the airway without adverse pressure being applied to the petiole of the epiglottis anteriorly, the arytenoid cartilage posteriorly, the aryepiglottic fold laterally or the false vocal fold inferiorly. Still further, there is no requirement for the device to penetrate the larynx so removing the possibility of damage to the delicate tissues of this structure.

While in place, and where the device is provided with a suction tube, suctioning of the pharynx/oesophagus can be provided on a intermittent or continuous basis.

When it is desired the remove the device, the cuff can be deflated and the device gently withdrawn.

In a fifth aspect, the present application is directed to an airway device comprising: a curved and/or flexible main tubular member comprising: a proximal end; a distal end; an anterior surface portion; a posterior surface portion; and at least one lumen extending from a proximal opening to a distal opening; an inflatable cuff at or adjacent the distal end; and a suction guidance tube mounted to said posterior surface portion of said main tubular member.

In this fifth aspect, the main tubular member can have an inner curvature defined by the anterior surface portion and an outer curvature defined by the posterior surface portion.

The proximal opening of the main tubular member can be at the proximal end of the tubular member. In another embodiment, the distal opening of the main tubular member can be at the distal end of the main tubular member. In a further embodiment, the main tubular member can have two or more distal openings with at least one distal opening being in the sidewall of the main tubular member adjacent the distal end. In yet another embodiment, the distal end can be oblique to the axis of the main tubular member at the distal end.

In one embodiment, the main tubular member can be formed in a curved configuration. The curvature can at least in part be circular, elliptical, parabolic or hyperbolic or a combination of one or more such curvatures. From its proximal end to its distal end, the main tubular member can define an arc of between about 90° and 170°, more preferably about 100°. The length can be between about 15cm and 35cm and can be dependent on the anatomy of the patient.

The main tubular member can be semi-rigid. In one embodiment, the main tubular member can preferentially retain the curved configuration on insertion into an airway.

In another embodiment, the main tubular member can be formed in a substantially straight configuration and be suitably flexible to adopt a curved configuration. In another embodiment, the main tubular member can be formed of a resiliently flexible material that allows the main tubular member to conform at least substantially to the anatomy of the airway of the patient on insertion.

In yet another embodiment, the main tubular member can be circular in cross- section and have an inner wall defining the lumen having an inner diameter. The inner diameter can be between about 0.5cm and 1.5cm, more preferably between about 0.6cm and 1.2cm, and most preferably about lcm or 0.8cm, or in the case of a child about 0.6cm. The main tubular member can have an outer diameter. The outer diameter can be between about 0.5cm and 2cm, more preferably between about 0.7cm and 1.7cm, most preferably about 1.09cm or 1.2cm, or in the case of a child about 0.75cm.

The main tubular member can be formed of a polymeric material. In one embodiment, the polymeric material can be transparent or translucent. The polymeric material can be polyvinyl chloride. A range of indicia can be provided on the main tubular member including information concerning dimensions of the tube, such as the inner and outer diameter and the length.

Still with regard to the fifth aspect, the cuff can be positioned adjacent the distal end of the main tubular member. In one embodiment, a distal end of the cuff can be between about 2cm and 4cm from the distal end of the main tubular member. The cuff can comprise a balloon member joined at its proximal and distal ends to the outer wall of the main tubular member. The join can be provided using a suitable adhesive and/or through use of plastic welding or suitable joining techniques.

The cuff can be formed of a relatively thin-walled polymeric material, such a polyethylene or polypropylene. The material making up the cuff can be transparent or translucent.

The cuff can be provided in different sizes suitable for different anatomies, for example, adult males, adult females and children. The cuff can be inflatable to an outer diameter of between about 2.5cm and 4cm.

Once the device is in the desired location in the airway, the cuff can be inflated using a fluid. The fluid can be air or other suitable gas. The fluid can be delivered to the cuff through an inflation tube. The inflation tube can have a distal end in fluid communication with the cuff and extend back to a proximal end having a connector port joined thereto. The connector port can have a Luer or Luer lock to allow appropriate connection of a syringe to the connector port and also comprise a nonreturn valve and an inflation indicator. In normal use, the inflation tube should have a length such that the proximal end is outside the patient's airway. The inflation tube can be formed separately to the main tubular member. In another embodiment, the inflation tube can for at least part of its length be joined to the main tubular member or extend therethrough. In another embodiment, at least part of the inflation tube can comprise a second lumen formed in the main tubular member. The inflation tube can have an outside diameter of between 0.15cm and 0.8cm, more preferably between about 0.2cm and 0.6cm. The inflation tube can be formed of a suitable plastics material, such as polyethylene, polypropylene or polyvinyl chloride.

The proximal end of the main tubular member can have a connector mounted thereto. The connector can be inserted into the proximal end of the main tubular member. A ventilator or the like can then connected to the connector when required.

In one embodiment, the suction guidance tube can have a lumen extending from a proximal end to a distal end. In one embodiment, the suction guidance tube can be formed separately and mounted to the posterior surface portion of the main tubular member. In another embodiment, the suction guidance tube can be formed integrally with the main tubular member. The proximal end of the suction guidance tube can be spaced distally from the proximal end of the main tubular member by a distance of between about 3cm and 6cm, more preferably about 4.5cm. The distal end of the suction guidance tube can be spaced proximally from the distal end of the main tubular member by a distance between about 12cm and 18cm, more preferably about 14cm. The suction guidance tube and/or the lumen of the suction guidance tube can be circular in cross-section and have an inner diameter and an outer diameter. The inner diameter can be between about 0.3 and 0.5cm, more preferably about 0.4cm and the outer diameter can be between about 0.4 and 0.6cm, more preferably about 0.5cm. The suction guidance tube can be formed of a suitable polymeric material, such as polyvinyl chloride.

In the fifth aspect, the position of the suction guidance tube serves to ensure that it does not interfere with visualisation of the larynx at the time of intubation. A suction tube can be inserted into and through the suction guidance tube. The suction tube can comprise a French size 12 suction tube but other sizes can be envisaged. The suction tube can be used to facilitate entraining air to achieve a sump suction effect within the pharynx and/or the oesophagus. The suction tube can be used either intermittently or continuously, following placement of the device, to withdraw any gastro-oesophageal soiling or soiling from above from the pharynx/oesophagus of the patient thereby reducing or eliminating the risk of aspiration.

While the device will be typically used for human patients, it will be appreciated that the device could be used, with suitable modification if necessary, on non-human patients requiring intubation.

According to a sixth aspect, the present application is directed to a method of intubating a patient comprising: advancing a device as defined herein with regard to the fifth aspect into an airway of a patient; inflating the inflatable cuff to seal the patient's airway; and inserting a suction tube through the suction guidance tube to continuously or intermittently withdraw any gastro-oesophageal soiling or soiling from above from the pharynx/oesophagus of the patient.

Brief Description of the Drawings

By way of example only, embodiments are now described with reference to the accompanying drawings, in which:

Fig. 1 is a side elevational view of one embodiment of the airway device or laryngeal hood;

Figs. 2a to 2c are different views of the hood member component of the device;

Fig. 3 is a cross-sectional view of a patient's airway depicting an embodiment of the device in one desired location within the patient;

Fig. 4 is a side elevational view of another embodiment of the airway device; and Fig. 5 is a cross-sectional view of a patient's airway depicting the embodiment of the device of Fig. 4 in one desired location within the patient.

Detailed Description of an Exemplary Embodiment

One embodiment of an airway device or laryngeal hood as defined herein is depicted generally as 10 in Figs. 1 to 3.

The depicted airway device 10 comprises a curved semi-rigid tube 11 having a proximal end 12, a distal end 13, and a lumen 14. In this embodiment, the lumen 14 extends from a proximal opening 15 formed at the proximal end 12 to a distal opening 16 formed at the distal end 13. The tube 11 further has an inner curvature 5 defined by an anterior surface portion 6 and an outer curvature 7 defined by a posterior surface portion 8.

In the depicted embodiment, the tube 11 can be smoothly curved. The curvature can at least in part be circular, elliptical, parabolic or hyperbolic or a combination of one or more such curvatures. From its proximal end to its distal end, the tube 11 can define an arc of between about 110° and 170°, more preferably about 145°. The length of the tube can be between about 15cm and 25cm and can be dependent on the anatomy of the patient.

The semi-rigid nature of the depicted tube 11 can serve to ensure that the tube 11 preferentially retain the curved configuration on insertion into an airway.

In another embodiment, the tube 11 can be formed in a substantially straight configuration and be suitably flexible to adopt a curved configuration if and when required. In another embodiment, the tube 11 can be formed of a resiliently flexible material that allows the tube 11 to conform at least substantially to the anatomy of the airway of the patient on insertion.

In the depicted embodiment, the tube 11 is circular in cross-section and has an inner wall defining the lumen 14. The inner diameter of the lumen can be between about 0.5cm and 1.5cm, more preferably between about 0.6cm and 1.2cm, and most preferably about lcm or 0.8cm, or in the case of a child about 0.6cm. The tube 11 also has an outer diameter. The outer diameter can be between about 0.5cm and 2cm, more preferably between about 0.7cm and 1.7cm, most preferably about 1.09cm or 1.2cm, or in the case of a child about 0.75cm.

The depicted tube 11 is formed from a transparent polyvinyl chloride. Other suitable non-transparent or translucent polymeric materials can be envisaged. Different types of indicia can be provided on the tube 11 including information concerning dimensions of the tube, such as the inner and outer diameter and the length.

The airway device 10 further comprises a hood member 17. In the depicted embodiment, the hood member 17 is non-removably positioned at the distal end 13 of the tube 11. It will be appreciated that the device 10 could be provided with a hood member 17 that was removable from the tube 11.

The hood member 17 is comprised of a mounting member 18 and a peripheral member 20. The mounting member 18 is mountable to the distal end 13 of the tube 11 and has a proximal end 19 and a distal end 21. The peripheral member 20 defines the periphery of the hood member 17. As depicted in Fig. 2b, the mounting member 18 can be disposed at an oblique angle to a notional plane 22 defined by at least a portion of the opening of the hood member 17. In this regard, the distal end 13 of the tube 11 can be formed at an oblique angle to the axis of the tube adjacent the distal opening 16 of the tube 11.

The peripheral member 20 is comprised of an inflatable cuff 25 that defines the entire periphery of a distal opening 30 of the hood member 17. The distal opening faces 30 in a direction away from the inner curvature 5 of the tube 11 defined by the anterior surface portion 6.

As depicted, the peripheral member 20 of the hood member 17 can be substantially elliptical. The peripheral member 20 can have a curved posterior end 23 portion and taper in width towards an anterior end 24. The anterior end 24 can be blunt to ensure substantially non-traumatic placement of the hood member in the supraglottic larynx.

In the depicted embodiment, the hood member 17 has been formed separately from the tube 11 and then mounted to the distal end 13. The hood member 17 can be mounted using a suitable adhesive and/or through use of plastic welding or suitable joining techniques. It will be appreciated that in other embodiments, the hood member 17 could be integrally formed with the tube 11. In another member, the cuff 25 can be formed separately to the mounting member 18 and appropriately joined thereto. In another embodiment, the mounting member 18 can be integrally formed on the tube 11 and the cuff 25 formed separately and appropriately joined to the mounting member 18.

The hood member 17 can be formed of a polymeric and/or elastomeric material. In one embodiment, the hood member 17 can be formed of a synthetic or natural rubber or a polyurethane. The material making up the hood member 17 can be transparent or translucent.

The hood member 17 can be provided in different sizes suitable for different anatomies, for example, adult males, adult females and children.

For an adult male, the length of the peripheral member 20 from the anterior end

24 to the posterior end 23 can be about 3.75cm. The inner dimension of the relatively long axis of the opening 30 (i.e. the axis that extends from the anterior end 24 to the posterior end 23) defined by the peripheral member 20 can be about 2.5cm. The width of the peripheral member 20 at its widest point can be about 2.5cm. The inner dimension of the relatively short axis of the opening 30 (i.e. an axis at right angles to the relatively long axis) defined by the peripheral member 20 can be about 1.5cm.

For an adult female, the length of the peripheral member 20 from the anterior end 24 to the posterior end 23 can be about 3cm. The inner dimension of the relatively long axis of the opening 30 (i.e. the axis that extends from the anterior end 24 to the posterior end 23) defined by the peripheral member 20 can be about 2cm. The width of the peripheral member 20 at its widest point can be about 2cm. The inner dimension of the relatively short axis of the opening 30 (i.e. an axis at right angles to the relatively long axis) defined by the peripheral member 20 can be about 1.2cm.

For children, the length of the peripheral member 20 from the anterior end 24 to the posterior end 23 can be about 1.8cm. The inner dimension of the relatively long axis of the opening 30 (i.e. the axis that extends from the anterior end 24 to the posterior end 23) defined by the peripheral member 20 can be about lcm. The width of the peripheral member 20 at its widest point can be about 1.2cm. The inner dimension of the relatively short axis of the opening 30 (i.e. an axis at right angles to the relatively long axis) defined by the peripheral member 20 can be about 0.8cm.

As described above, at least a portion of the hood member opening can lie in or define a notional plane 22. In the depicted embodiment, the notional plane 22 of the hood member opening 30 is defined by the most distal surface of the inflatable cuff 25 at the posterior end 23 and the anterior end 24 of the cuff 25. These locations are depicted as features 23a and 24a in Fig. 2b.

The geometry of the hood member 17 relative to the tube 11 is such that a line

31 tangential to the inner curvature 5 of the anterior surface portion 6 at said distal end 13 is at an outside angle to the notional plane 22 of greater than 90°. The angle α can be between 90° and 170°, more preferably between about 130° and 160°, yet more preferably between about 140° and 160°, and still more preferably, and as depicted, between about 145° and 155°.

As further depicted a line 32 tangential to the posterior surface portion 8 at the distal end 13 of the tube 11 can also have an outside angle β of greater than 90° to the notional plane 22. The angle β can be between 90° and 170°, more preferably between about 120° and 150°, yet more preferably between about 125° and 150°, and still more preferably, and as depicted, between about 130° and 140°.

As also depicted in Fig. 1, the notional plane 22 defined by said at least a portion of the opening 30 of the periphery of the hood member 17 can be at angle of between about 80° and 100°, more preferably about 90°, to a notional plane 43 defined by either the proximal opening 15 of the tube 11 or the proximal opening of a connector 39 positioned in the proximal opening 15.

As depicted in Fig. 3, the device 10 is adapted to be placed in an airway of a patient such that the hood member 17 is positionable in the supraglottic larynx.

Once the device 10 is in the desired location in the airway 41, the cuff 25 is inflated using a fluid. The fluid can be air or other suitable gas. The fluid can be delivered to the cuff 25 through an inflation tube 33. The inflation tube 33 has a distal end 34 in fluid communication with the cuff 25 and extends back to a proximal end 35 having a connector port 36 joined thereto. The connector port 36 has a Luer or Luer lock 37 to allow appropriate connection of a syringe to the connector port 36 and also comprises a non-return valve and an inflation indicator 38. In normal use, the inflation tube 33 should have a length such that the proximal end 35 is outside the patient's airway 41.

As depicted, the inflation tube 33 can be formed separately to the tube 11 and for at least a portion of its length be joined to the tube 11. In another embodiment, the inflation tube 33 can, for at least part of its length, comprise an additional integral lumen in the tube 11. The inflation tube 33 can have an outside diameter of between 0.15cm and 0.8cm, more preferably between about 0.2cm and 0.6cm. The inflation tube 33 can also be formed of a suitable plastics material, such as polyethylene, polypropylene or polyvinyl chloride. The volume of the inflatable cuff 25 can be between 0.6ml and ImI, more preferably about 0.7ml or 0.75ml.

The proximal end 12 of the tube 11 has the connector 39 inserted therein. A ventilator or the like can then connected to the connector 39 when required.

The device 10 further comprises a suction tube 51. The suction tube 51 has a lumen 52 extending from a proximal end 53 to a distal end 54. In the depicted embodiment, the suction tube 51 has been formed separately and mounted on the tube 11. In another embodiment, the suction tube 51 can be formed integrally with the tube 11. The proximal end 53 of the suction tube 51 can be spaced distally from the proximal end 12 of the tube 11 by a distance of between about 2.5cm and 5cm, more preferably about 3cm. The distal end 54 of the suction tube 51 can be spaced proximally from the distal end 13 of the tube 11 by a distance between about 3cm and 8cm, more preferably about 5cm. The suction tube 51 and/or the lumen 52 of the suction tube 51 can be circular in cross-section and have an inner diameter and an outer diameter. The inner diameter can be between about 0.3 and 0.5cm, more preferably about 0.4cm and the outer diameter can be between about 0.4 and 0.6cm, more preferably about 0.5cm. The suction tube 51 can be formed of a suitable polymeric material, such as polyvinyl chloride.

The suction tube 51 can be used either intermittently or continuously, following placement of the device 10, to withdraw matter from the pharynx/oesophagus of the patient. In the embodiments depicted by Figs. 1 to 3, a suction guidance tube can be mounted to the posterior surface portion of the tube 11. While not depicted in Figs. 1 to 3, in one embodiment, the suction guidance tube can take the form of the suction guidance tube 510 described below with reference to Figs. 4 and 5.

In use, the device 10 can be used to intubate a patient. Use can comprise advancing the device 10 into the airway 41 of the patient, and ensuring the hood member 17 is positioned in the supraglottic larynx.

Once in position, the cuff 25 can be inflated to seal the patient's airway 41 around the periphery of the hood member 17.

The use and positioning of the device 10 does allow, if desired, the device to be left in place when the patient is aroused and/or transported to a recovery ward. Still further, the proposed position and dimensions of the hood member 17 as defined herein allows the hood member 17 to be stabilised in the airway 41 without adverse pressure being applied to the petiole of the epiglottis anteriorly, the arytenoid cartilage posteriorly, the aryepiglottic fold laterally and/or the false vocal fold inferiorly. Still further, there is no requirement for the device 10 to penetrate the larynx 42 so removing the possibility of damage to the delicate tissues of this structure.

While in place, and where the device 10 is provided with a suction tube 51, suctioning of the pharynx/oesophagus 43 can be provided on a intermittent or continuous basis.

When it is desired the remove the device 10, the cuff 25 can be deflated and the device 10 gently withdrawn.

Another embodiment of an airway device as defined herein is depicted generally as 100 in Figs. 4 and 5. The depicted airway device 100 comprises a curved semi-rigid main tube 110 having a proximal end 120, a distal end 130, and a lumen 140. In this embodiment, the lumen 140 extends from a proximal opening 150 formed at the proximal end 120 to a first oblique distal opening 16a formed at the distal end 130. In the depicted embodiment, a second distal opening 16b is provided in the sidewall of the main tube 110 adjacent the distal end 130. The main tube 110 further has an inner curvature 50 defined by an anterior surface portion 60 and an outer curvature 70 defined by a posterior surface portion 80.

In the depicted embodiment, the main tube 110 can be smoothly curved. The curvature can at least in part be circular, elliptical, parabolic or hyperbolic or a combination of one or more such curvatures. From its proximal end to its distal end, the main tube 110 can define an arc of between about 90° and 170°, more preferably about 100°. The length of the main tube can be between about 15cm and 35cm and can be dependent on the anatomy of the patient.

The semi-rigid nature of the depicted main tube 110 can serve to ensure that the tube 110 preferentially retain the curved configuration on insertion into an airway.

In another embodiment, the main tube 110 can be formed in a substantially straight configuration and be suitably flexible to adopt a curved configuration if and when required. In another embodiment, the main tube 110 can be formed of a resiliently flexible material that allows the tube 110 to conform at least substantially to the anatomy of the airway of the patient on insertion.

In the depicted embodiment, the main tube 110 is circular in cross-section and has an inner wall defining the lumen 140. The inner diameter of the lumen can be between about 0.5cm and 1.5cm, more preferably between about 0.6cm and 1.2cm, and most preferably about lcm or 0.8cm, or in the case of a child about 0.6cm. The main tube 110 also has an outer diameter. The outer diameter can be between about 0.5cm and 2cm, more preferably between about 0.7cm and 1.7cm, most preferably about 1.09cm or 1.2cm, or in the case of a child about 0.75cm.

The depicted main tube 110 is formed from a transparent polyvinyl chloride. Other suitable non-transparent or translucent polymeric materials can be envisaged. Different types of indicia can be provided on the main tube 110 including information concerning dimensions of the tube, such as the inner and outer diameter and the length.

The airway device 100 further comprises an inflatable cuff member 170. In the depicted embodiment, the cuff member 170 is positioned adjacent the distal end 130 of the main tube 110. In the depicted embodiment, a distal end of the cuff member 170 is about 2.5cm from the distal end 130 of the main tube 110 and comprises a balloon member joined at its proximal and distal ends to the outer wall of the main tube 110.

The join can be provided using a suitable adhesive and/or through use of plastic welding or suitable joining techniques.

The cuff member 170 can be formed of a relatively thin- walled polymeric material, such as polyethylene or propylene, and can be transparent or translucent.

The cuff member 170 can be provided in different sizes suitable for different anatomies, for example, adult males, adult females and children. The cuff member 170 can be inflatable to an outer diameter of between about 2cm and 4cm.

As depicted in Fig. 5, the device 100 is adapted to be placed in an airway 41 of a patient such that the cuff member 170 is positioned distal the larynx 42.

Once the device 100 is in the desired location in the airway 41 , the cuff member 170 is inflated using a fluid. The fluid can be air or other suitable gas. The fluid can be delivered to the cuff member 170 through an inflation tube 330. The inflation tube 330 has a distal end 340 in fluid communication with the cuff member 170 and extends back to a proximal end 350 having a connector port 360 joined thereto. The connector port 360 has a Luer or Luer lock 370 to allow appropriate connection of a syringe to the connector port 360 and also comprises a non-return valve and an inflation indicator 380. In normal use, the inflation tube 330 should have a length such that the connector port 360 is outside the patient's airway 41.

As depicted, the inflation tube 330 can be formed separately to the main tube

110 and for at least a portion of its length be joined to the tube 110. In another embodiment, the inflation tube 330 can, for at least part of its length, comprise an additional integral lumen in the main tube 110. The inflation tube 330 can have an outside diameter of between 0.15cm and 0.8cm, more preferably between about 0.2cm and 0.6cm. The inflation tube 330 can also be formed of a suitable plasties material, such as polyethylene, polypropylene or polyvinyl chloride.

The proximal end 120 of the tube 110 has the connector 390 inserted therein. A ventilator or the like can then connected to the connector 390 when required.

The device 100 further comprises a suction guidance tube 510. The suction guidance tube 510 has a lumen 520 extending from a proximal end 530 to a distal end 540. In the depicted embodiment, the suction guidance tube 510 has been formed separately and mounted on the posterior surface portion 80 of the main tube 110. In another embodiment, the suction guidance tube 510 can be formed integrally with the main tube 110. The proximal end 530 of the suction guidance tube 510 can be spaced distally from the proximal end 120 of the tube 110 by a distance of between about 3cm and 6cm, more preferably about 4.5cm. The distal end 540 of the suction guidance tube 510 can be spaced proximally from the distal end 130 of the tube 110 by a distance between about 12cm and 18cm, more preferably about 14cm. The suction guidance tube 510 and/or the lumen 520 of the suction guidance tube 510 can be circular in cross-section and have an inner diameter and an outer diameter. The inner diameter can be between about 0.3 and 0.5cm, more preferably about 0.4cm and the outer diameter can be between about 0.4 and 0.6cm, more preferably about 0.5cm. The suction guidance tube 510 can be formed of a suitable polymeric material, such as polyvinyl chloride.

The position of the suction guidance tube 510 serves to ensure that it does not interfere with visualisation of the larynx at the time of intubation. A suction tube 600 can be inserted into and through the suction guidance tube 510. The suction tube 600 can comprise a French size 12 suction tube but other sizes can be envisaged. The suction tube 600 can be used to facilitate entraining air to achieve a sump suction effect within the pharynx and/or the oesophagus. The suction tube can be used either intermittently or continuously, following placement of the device 100, to withdraw any gastro-oesophageal soiling or soiling from above from the pharynx/oesophagus of the patient thereby reducing or eliminating the risk of aspiration.

While the device 100 will be typically used for human patients, it will be appreciated that the device 100 could be used, with suitable modification if necessary, on non-human patients requiring intubation. In use, the device 100 can be used to intubate a patient. Such use can comprise advancing the device 100 into the airway 41 of the patient, and ensuring the cuff member 170 is positioned distal the larynx 42.

Once in position, the cuff member 170 can be inflated to seal the patient's airway 41. The suction tube 600 can then be inserted through the suction guidance tube 510 and suction can then be applied to the tube to continuously or intermittently withdraw any soiling from the pharynx or oesophagus of the patient.

When it is desired the remove the device 100, the cuff member 170 can be deflated and the device 100 gently withdrawn.

It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the invention as shown in the specific embodiments without departing from the scope of the invention as broadly described.

The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.

Claims

CLAIMS:

1. An airway device comprising: a curved and/or flexible tubular member comprising: a proximal end; a distal end; an anterior surface portion; a posterior surface portion; and at least one lumen extending from a proximal opening to a distal opening; and a hood member at or adjacent the distal end comprising a periphery defining an opening in fluid communication with said distal opening; wherein the opening of said hood member faces in a direction away from the anterior surface portion of the tubular member.

2. The airway device of claim 1 wherein the tubular member has: an inner curvature defined by the anterior surface portion; and an outer curvature defined by the posterior surface portion, wherein a line tangential to the inner curvature of the anterior surface portion at the distal end of the tubular member is at an outside angle to a notional plane defined by at least a portion of the hood member opening; and further wherein the outside angle is greater than 90°.

3. An airway device comprising: a curved and/or flexible tubular member having an inner curvature and an outer curvature and comprising: a proximal end; a distal end; said inner curvature defined by an anterior surface portion; said outer curvature defined by a posterior surface portion; and at least one lumen extending from a proximal opening to a distal opening; and a hood member at or adjacent the distal end comprising a periphery defining an opening in fluid communication with said distal opening, at least a portion of the hood member opening having a notional plane; and wherein a line tangential to the inner curvature of the anterior surface portion at said distal end is at an outside angle to said notional plane, said outside angle being greater than 90°.

4. The airway device of claim 3 wherein the opening of said hood member faces in a direction away from the anterior surface portion of the tubular member.

5. The airway device of any one of the preceding claims wherein the hood member is positionable in the supraglottic larynx of a patient on appropriate placement of the device in an airway of the patient.

6. An airway device comprising: a curved and/or flexible tubular member comprising: a proximal end; a distal end; and at least one lumen extending from a proximal opening to a distal opening; and a hood member at or adjacent the distal end comprising a periphery defining an opening in fluid communication with said distal opening; wherein on appropriate placement of the device in an airway of a patient the hood member is positionable in the supraglottic larynx.

7. The airway device of claim 6 wherein the tubular member has: an anterior surface portion; and a posterior surface portion; wherein the opening of the hood member faces in a direction away from the anterior surface portion.

8. The airway device of claim 7 wherein the tubular member has: an inner curvature defined by the anterior surface portion; and an outer curvature defined by the posterior surface portion, wherein a line tangential to the inner curvature of the anterior surface portion at the distal end of the tubular member is at an outside angle to a notional plane defined by at least a portion of the hood member opening; and further wherein the outside angle is greater than 90°.

9. The airway device of any one of the preceding claims wherein the hood member is positioned at the distal end of the tubular member.

10. The airway device of any one of claims 2, 3 or 8 wherein the hood member is comprised of: a mounting member that is mountable to the tubular member; and a peripheral member positioned at a distal end of the mounting member and which defines a periphery of the hood member.

11. The airway device of claim 10 wherein the mounting member is disposed at an oblique angle to the notional plane of said at least a portion of the opening of the hood member.

12. The airway device of claim 10 or claim 11 wherein the peripheral member is comprised at least in part of an inflatable cuff.

13. The airway device of any one of claims 10 to 12 wherein the peripheral member has a curved posterior end portion and tapers in width towards an anterior end.

14. The airway device of any one of claims 2, 3 or 8 wherein the outside angle is between 90° and 170°, more preferably between about 130° and 160°, yet more preferably between about 140° and 160°, and still more preferably between about 145° and 155°.

15. The airway device of any one of claims 2, 3, 8 or 14 wherein a line tangential to the posterior surface portion at the distal end of the tubular member is at an outside angle of greater than 90° to the notional plane defined by said at least a portion of the hood member opening.

16. The airway device of claim 15 wherein the outside angle between the line tangential to the posterior surface portion at the distal end of the tubular member and the notional plane is between 90° and 170°, more preferably between about 120° and 150°, yet more preferably between about 125° and 150°, and still more preferably between about 130° and 140°.

17. The airway device of any one of claims 2, 3, 8, or 14 to 16 wherein the notional plane defined by said at least a portion of the opening of the periphery of the hood member is at angle of between about 80° and 100°, more preferably about 90°, to a notional plane defined by the proximal opening of the tubular member.

18. A method of intubating a patient comprising: advancing a device as defined by any one of claims 1 to 17 into an airway of a patient; and positioning the hood member in the supraglottic larynx.

19. An airway device comprising: a curved and/or flexible main tubular member comprising: a proximal end; a distal end; an anterior surface portion; a posterior surface portion; and at least one lumen extending from a proximal opening to a distal opening; an inflatable cuff at or adjacent the distal end; and a suction guidance tube mounted to said posterior surface portion of said main tubular member.

20. The airway device of claim 19 wherein the suction guidance tube: has a lumen extending from a proximal end to a distal end; the proximal end of the suction guidance tube being spaced distally from the proximal end of the main tubular member by a distance of between about 3cm and 6cm, more preferably about 4.5cm; and the distal end of the suction guidance tube being spaced proximally from the distal end of the main tubular member by a distance between about 12cm and 18cm, more preferably about 14cm.

21. A method of intubating a patient comprising: advancing a device as defined by claim 19 or claim 20 into an airway of a patient; inflating the inflatable cuff to seal the patient's airway; and inserting a suction tube through the suction guidance tube to continuously or intermittently withdraw any gastro-oesophageal soiling or soiling from above from the pharynx/oesophagus of the patient.