SUPRAGLOTTIC AIRWAY DEVICE WITH A DYNAMIC CUFF WITH SUPERIOR VENTILATING CAPABILITY

Abstract

This invention is a device to be used with a system for supplying anaesthetic or respiratory gases into the airway of a human or an animal. This device is a supraglottic airway device, which includes a shaft with three tubes one for ventilation purpose and rest two for dynamic cuff inflation and other for suctioning purpose. The dynamic cuff is inflated by the gases supplied directly from the anaesthesia or ventilator circuit through a specialised adaptor via dynalumen. The cuff inflation lumen (DynaLumen) will also be having a locking mechanism to enable its use like a conventional LMA; i.e., the cuff can be left continuously inflated both during positive pressure ventilation as well as less during expiratory phase and during spontaneous respiration.

Claims

1) An airway device for insertion into the oral cavity comprising of a shaft, a proximal end, a distal end and a specialised connector a) The body or shaft comprises of three cylindrical tube members (Tube 1, Tube 2, and Tube 3) arranged with their long axes adjacent to each other. b) The proximal end of the shaft is connected to the mechanical ventilator/manual resuscitator through a specialised connector (adapter) through the proximal ends of the cylindrical tube members Tube 1 and Tube 2. c) The distal end of the shaft comprises of an almond shaped/elliptical bowl mainly formed by the distal end of the Tube 2, which is surrounded by inflatable cuffs on its sides and at the rear.

2) The Tube 1 as set forth in claim 1 (a), extends from the proximal end of the shaft, along the Tube 2 (as set forth in claim 1 (a)) till the distal end, where it terminates inside one or more inflatable cuffs as set forth in claim 1(c).

3) The Tube 2 as set forth in claim 1(a) extends from the proximal end of the shaft till the distal end, where it terminates forming an almond shaped/elliptical bowl which rests over the glottis when positioned in the patient's pharynx, enabling air exchange.

4) The Tube 3 as set forth in claim 1(a) extends from the proximal end of the shaft along the Tube 2 (as set forth in claim 3) and extends behind the bowl of Tube 2, all the way till the distal tip of the device, where it opens up into the esophageal lumen.

5) The Tube 3 as set forth in claim 4, in its distal portion, behind the bowl of the device, may have multiple apertures on its walls, enabling clearing of secretions collected in the pharynx, via suctioning.

6) The specialised connector adaptor as set forth in claim 1, as a proximal ventilator end and a distal patient end. The proximal ventilator end has a standard 15 mm male port which fits into a standard 22 mm female port of ventilator circuit/AMBU resuscitators.

7) The distal Patient end of the specialised connector as set forth in claim 6 has two ports, preferably of unequal sized terminals: The larger terminal may connect to the proximal end of Tube 2, as set forth in claim 1, preferably via a 15 mm male connector. The smaller terminal of the specialised adapter connects to the proximal end of the Tube 1 through a suitable connector.

8) In the distal end of the specialised connector, just proximal to the larger terminal which connects to the proximal end of Tube 2, can be a side port, which can be used for expiratory carbon dioxide monitoring via sidestream capnometry.

9) The inflatable cuffs, as set forth in claim 1(c), get inflated during positive pressure ventilation, forming a airtight seal in the pharynx, and deflate during expiration.

10) Both the inflatable cuffs, as set forth in claim 1(c), may be inflated with the ventilation of the Tube 1 directly, or through interconnecting holes on the walls separating them.

11) In an alternate embodiment, the two inflatable cuffs as set forth in claim 1(c) may be substituted with a single cuff of suitable design or with a plurality of cuffs.

12) Another variation of this cuff design, as set forth in claim 1(c), is where a compressible sponge/foam fills either or both compartments of the inflatable cuff, which allows to be collapsed while inserting the device into the pharynx but reexpands upon insertion to regain its original shape upon exposure to atmospheric pressure, thereby preventing tongue fall and airway obstruction. During PPV (positive pressure ventilation) this cuff gets inflated as discussed in the primary embodiment, and provides a better air tight seal over and above the one achieved with the reexpansion of the sponge/foam.

13) Near the proximal end of the device, outside the Tube 1, is a lock which can occlude the lumen of Tube 1 when the inflatable cuffs are left in inflated position. This can help in spontaneously breathing patients.

14) Proximal to the lock on the Tube 1, as set forth in claim 11, is a 3 way inflation system to inflate the inflatable cuffs with a syringe or any suitable instrument.

15) In an alternate embodiment, the inflatable cuffs, as set forth in claim 1 (c), can communicate with the lumen of Tube 2 through one or several apertures, enabling equilibration of the air pressures at the distal end level.

16) In an alternate embodiment, one of the two inflatable cuffs, as set forth in claim 1(c), can be inflated via the lumen of Tube 3 (as set forth in claim 1(a)), wherein, the distal end of Tube 3 will not end in the esophageal lumen, but will end inside the cuff which it is inflating.

17) In the alternative embodiment as set forth in claim 13, one of the inflatable cuffs can be left permanently inflated and the other cuff alone can function as a self pressurising cuff which expands with positive pressure.

18) In another alternative embodiment, one of the two inflatable cuffs can be inflated from the lumen of the Tube 2 during positive pressure ventilation. The other inflatable cuff can be permanently inflated, deflated or self pressurised through its inflating lumen (Tube 1 or Tube 3)

Description

DETAILED DESCRIPTION OF THE DEVICE

[0039] FIG. 1 shows device has a main body which is called a shaft (1). The shaft consists of three cylindrical tubes next to each other, extending all the way from the proximal end till the distal end of the shaft. The shaft is made of soft but thick silicone/any other suitable material making it washable and non kinkable.

[0040] The proximal end of the shaft is also called as the Ventilator End (2) and the distal end is called Pharyngeal end (3)

[0041] Of the three tubes, the central one is the largest. This is called the Ventilating Lumen VentiLumen (4) whose function is to deliver the ventilating gases in and out of the lungs via the glottis. The proximal end of the Ventilumen is connected to the special adapter (5) and distally it ends as the bowl just over the glottis, enabling Direct suctioning of the glottis bronchoscopic suction/bronchoscopy & lavage/bougie guided tracheal intubation in patients with difficult laryngoscopy and intubation.

[0042] A smaller cylindrical tube is present on one of the sides of the Ventilumen. This tube pushes the air in and out of the Dynamic Cuff during positive pressure ventilation and this lumen is called DynaLumen (6). The proximal end of the Dynalumen is connected to the specially designed adapter and its distal end in the Compartment A of the DynaCuff. Just before ending in the Compartment A of the DynaCuff, the Dynalumen also inflates the Compartment B through the side holes. (Diag No. 2)

[0043] A specially designed adapter (5) connects the proximal end of this device to the Ventilator circuit/AMBU resuscitator. The adapter has a proximal end (7) and a distal end has two ports (8). The proximal end has a standard 15 mm female/22 mm male port, which can be connected to the ventilator circuit/AMBU resuscitator. The distal end of the adapter has 2 ports: of the two, the larger one (4a) is a 15 mm female port, which gets attached to the Universal connector at the proximal end of the VentiLumen. The smaller port (6a) is attached to the tip of the DynaLumen.

[0044] Near the proximal end of the DynaLumen lies a clip like locking system (9) which can be used to keep the Dynamic cuff continuously inflated (as may be required in spontaneous respiration) The proximal end of the DynaLumen has an adapter which enables to inflate the DynaCuff with a 3-way stopcock and a Syringe.

[0045] The third circular tube (10) is the lumen which is used to suction and removal of pharyngeal secretions and secretions this lumen also used to insert a ryles tube or a specialised GOJO tube which can be used to prevent aspiration in a patient with full stomach.

[0046] At the distal end of the shaft, the middle lumen (VentiLumen) (4) ends in cavity called as Bowl (11). This bowl rest directly over the glottis. The ventilatory gases from here reach the lungs via the glottis. Around and behind the bowl, lies the DynamicCuff (12)

[0047] FIG. 2. Shows the back portion or the posterior aspect of the device wherein the dynamic cuff is divided into two compartments. The portion surrounding the bowl is the Compartment A (14) and the portion behind the bowl is called Compartment B (13). The DynaLumen extends all the way through the Compartment B into the Compartment A and ends inside the latter. En route to the Compartment A the DynaLumen inflates (and deflates) the Compartment B through its side holes(17) and its tip(18) inflates (and deflates) Compartment A. The inflation of these two compartments provide the airtight supraglottic seal during PPV (positive pressure ventilation)

[0048] A variation of this cuff design is where a deflatable sponge/foam fills partially or completely, either or both compartments of the Dynamic cuff, which can be collapsed while inserting the device into the pharynx but reexpands upon insertion to regain its original shape, thereby preventing tongue fall and airway obstruction. During PPV (positive pressure ventilation) the dynamic cuff gets inflated and provides a better seal over and above the one achieved with the SpongeCuff (DynaSponge.). Figure also shows distal end (16) of the suctioning lumen (10) and multiple arertures proximal to it for pharyngeal suctioning(15).

[0049] FIG. 3. Shows the cut section of the device at the level of the bowl wherein the portion surrounding the bowl is the Compartment A (14) and the portion behind the bowl is called Compartment B (13). The Dyna Lumen extends all the way through the Compartment B into the Compartment A and ends inside the latter. En route to the Compartment A the Dyna Lumen inflates (and deflates) the Compartment B through its side holes(17) and its tip(18) inflates (and deflates) Compartment A. FIG. 4 describes the special adaptor.

[0050] FIG. 5 shows the cut section of the Shaft. Here the central lumen(4) is the largest and it is directly connecting to the bowl(11) of the device and the two smaller lumens on the sides are the ones which inflate the DynaCuff (6) and the suction/Ryles tube insertion port (10)

[0051] FIG. 6 shows the working model of the device in inspiratory phase within the patients pharyngeal cavity.