GB2529650A

GB2529650A - Self sealing absorbent subglottic airway device

Info

Publication number: GB2529650A
Application number: GB1415180.7A
Authority: GB
Inventors: Carl Michael Walkden
Original assignee: Individual
Current assignee: Individual
Priority date: 2014-08-27
Filing date: 2014-08-27
Publication date: 2016-03-02
Also published as: GB201415180D0

Abstract

An airway device comprises an airway tube 1, foam cuffs 3,4, and a gastric channel 2. One end of the airway tube has a silicon seal 1 at one end, and a connector 7 at the other for connection to the breathing system (not shown). Surrounding the airway tube and the gastric tube are two cuffs 3, 4. One cuff 3 is made from closed cell foam, which may be compressed for insertion into the throat; it then expands to seal the throat. The other cuff 4 is made from open cell foam, which absorbs fluids to prevent inhalation. The cuff removes the need for a secondary throat pack.

Description

I

SELF SEALING ABSORBENT SLJBGLOTTIC AIRWAY DEV)CE flnd Both inflatable and non inflatable subgkttic airway devices are available for positioning in the pharynx to secure the airway. Some of the devices currently on the market are supplied preformed.

reinforced and are available with and without a gastric channel which manages gastric fluid.

During some surgical procedures involving the upper airway, it requires a throat/pharyngeal pack to be placed around the device, to aid reduction in the risk of post operative nausea and vomiting, The positioning of such a pack can displace the airway, reducing the seal and increasing the risk of aspiration. It has a]so been well documented that these packs increase the risk of sore throat and can also lead to a "never event" by retention of the throat pack.

Introduction

Our Self Sealing Absorbent Airway Device has two unique features. The Closed Cell Foam (3) element allows the device to be positioned in the pharynx and become stable within a short period time following insertion.

The Open CeO Foam (4) ailows for absorption of fluid/blood from the upper airway, ebminating the need for a secondary throat/pharyngeal pack to be used. Whilst absorbing the fluid/blood it increases the airway seal by expanding the device between the post pharyngeal wall and laryngeal inlet.

Problem 1:0 spiacementof Aitway Seal due to use of ThroaPharyneal Pack Throat packs are commonly used during some upper airway surgical procedures. The insertion of the pack can displace the airway device leading to a poor seal and increase the risk of aspiration. Our device with its unique feature Closed Cell Foam (3) eliminates the need for any packing and reduces the risk of displacement, Problem 2: Retained ThçfPhangeal fcJ"N&erjventC) The World Health Organisation (WHO) has class Wed the retention of a throat pack as a "never event', This is now classed as a reportable offence and clinicians are now required to significantly reduce the number of "never events" occurring, Our failsafe device eliminates the need for a secondary throat pack to be used, aiding the reduction of "never events".

Problem 3: Poor Ventilation Pressures Inflatable and non inflatable subglottic airway devices that are positioned in the pharynx to seal the lower airway are all size specific. Occasionally the incorrect sized device may be used (This is mainly due to the emergency of the procedure, or the incorrect size being chosen) due to the weight of the patient not being in accordance with the anatomical structure). Our unique features such as the Closed Cell Foam (3) and the Open Cell Foam (4) ensures that an adequate seal can be achieved on a wider spectrum of patients compared to all standard devices currently on the market.

The Closed Cell Foam (3) along with the Open Cell Foam (4), once positioned in the pharynx will continue to expand delivering an improved seal, enabling a higher level of ventilation to be achieved, Problem 4: Unstable Subglottk Airway Device Inflatable and non inflatable devices used in the pharynx can become unstable due to under inflation, incorrect sizing or movement of the proximal connector and/or the breathing system.

Movement of the proximal connector or patient can lead to the displacement of the distal tip. This will increase the risk of aspiration and reduce ventilation pressures. Our device, due to its unique Closed Cell Foam (3) and Open Cell Foam (4) will act as an internal shock absorber, reducing the transmission of any force by the movement of**the proximal connector, ensuring the distal tip remains correctly positioned.

a tive Sore Throat The use of inflatable and non inflatable subglottic devices in the pharynx and the use of any secondary throat/pharyngeal pack can increase the risk of post operative sore throats, Over inflation of any device and increased pressure in the pharynx, along with vigorous packing by forceps or fingers, will also significantly increase the risk of post operative sore throat, The construction of our device with its non inflatable cuff and compressible foam material eliminates the risk of over inflation and the need for a secondary pack to be inserted.

Problem,stOerate Nausea and Vomit As with all current devices, if a secondary throat pack is not used on patients undergoing upper airway surgical procedures, there is a risk that the patient may retain an increased amount of fluid in the stomach. This may increase the risk of post operative nausea and vomiting. Our device with its Open Cell Foam (4) and Gastric Channel (2), eliminates the risk of any post operative nausea and vomiting due to the absorption of the foam and the ability to apply suction to the patient via the Gastric Channel (2).

Description Summary

Our device is designed to overcome the probems associated with the inflatable and non inflatable subglottic airway devices used in the lower pharynx, All current devices can be split into two groups, reinforced and non reinforced. Both groups are available with and without a gastric channel. All of the devices are prone to movement of the distal tip and leakage due to over inflation (if applicable), incorrect sizing and/or movement of the patient, breathing system or the proximal connector of the device. Transmission of any force from the proximal connector could lead to displacement of the distal tip. The use of a secondary throat/pharyngeal pack during upper airway surgical procedures can also lead to displacement and leakage.

The unique structure of both our standard preformed device as shown in FIG, 1 and the reinforced version shown in FIG. 4 will greatly reduce the risk of displacement of the distal tip due to the construction of both the Closed Cell Foam (3) and the Open Cell Foam (4).

There are two versions of the device, the first being a preformed, anatomically shaped, Airway Tube with Silicone Seal (1) to aid insertion, as shown in FIG. 1. The second version has a reinforced, silicone or plastic airway tube that consists of an internal spiral wire, which runs from the 15mm connector (7) at the proximal end, down to the silicone seal -as shown in FIG. 4. Both versions are supplied with a Gastric Channel (2) that runs through to the Distal Tip (5) to allow for suctioning and venting of any gastric content. The Gastric Channel (2) has a wide enough bore that aflows for suctioning via an appropriately sized suction catheter. Both versions have a 15mm connector (7) at the proximal end for connection to a suitable breathing system.

Both versions share the same cuff that sits between the post pharyngeal wall and laryngeal inlet. The cuff is constructed as shown in FIG. 2 and FIG. 5, from either a Preformed Airway Tube with Silicone Seal (1) or a Reinforced Airway Tube with Silicone Seal (6) as shown in FIG-5. The remainder of the cuff is constructed with a gastric channel (2), which runs the full length of the airway tube from the 15mm connector (7) at the proximal end through to the dista tip of the airway device. Above the level of the Gastric Channel (2) are two unique foam materials. The foam material sitting directly above the Preformed Airway Tube with Silicone Seal (1) or the Reinforced Airway Tube with Sliicone Seal (6) and the Gastric Channel (2) is a Closed Cell Foam (3). The Closed Cell Foam (3) has a dual function. Firstly to prevent leakage of any fluid from the Open Cell Foam (4), leaking into the lower airway. Secondly, it has a decompression time, that when compressed, will allow for insertion before fully decompressing, enabling the device to be fixed in the correct position. Above the level of Closed Cell Foam (3) is the Open Cell Foam (4) which will expand once in contact with any fluids or blood in the pharynx or running down from the upper airway. The expansion of this foam is gentle but will increase the overall sealing performance of the device.

BRIEF DESCRIPTION OF DRAWINGS

1. Preformed Airway Tube with Silicone Seal 2. Gastric Channel 3. Closed Cell Foam 4. Open Cell Foam 5. Gastric Channel Distal Tip 6. Reinforced Airway Tube with Silicone Seal 7. 15mm Male Connector FlG1 A fully decompressed side view of the Airway Device showing the Preformed Airway Tube with Silicone Seal (1), along with Gastric Channel (2) with its Distal Tip(S). Above the Silicone Seal sits the Closed Cell Foam (3) that is compressib'e for insertion. The upper Open Cell Foam (4) is the absorbent material.

FIG. 2 An exploded side view of the Airway Device (FIG. 1).

FIG, 3 A partially cross sectioned, partially schematic view of an embodiment of the Airway Device fully decompressed between the post pharyngeal wall and the laryngea inlet, with the Gastric Channel Distal Tip (5) positioned at the top of the oesophagus.

FIG. 4 A similar view to FIG. 1, but this time using a Reinforced Airway Tube with Silicone Seal (6).

FIG. 5 An exploded side view of the Airway Device, similar to FIG. 2, but this time showing the Reinforced Airway Tube with Silicone Seal (6).

FIG, 6 A partially cross sectioned, partially schematic view of an embodiment of the Airway Device fully decompressed between the post pharyngeal wall and the laryngeal inlet, with the Gastric Channel Distal Tip (5) positioned at the top of the oesophagus, this time showing the Reinforced Airway Tube with Silicone Seal (6).