WO2022129961A1

WO2022129961A1 - Articulated bougie with syring

Info

Publication number: WO2022129961A1
Application number: PCT/GR2021/000077
Authority: WO
Inventors: Symeon Grigoriou
Original assignee: Symeon Grigoriou
Priority date: 2020-12-19
Filing date: 2021-12-08
Publication date: 2022-06-23
Also published as: GR1010177B

Abstract

It is an articulated bougie with a syringe made of materials that we find inside an operating room. It is characterized by the ability of vertical bending of the distal end by means of lifting the plunger of the syringe (FIGURE No2). This articulated bougie (FIGURE No.1) consists of: A syringe (1), the connection by a suction catheter (2), a bougie with a central hollow lumen (3), an inelastic surgical thread (4) that goes through the bougie and connects the syringe plunger to the tip of the flexible end and the flexible end (5) made of a conventional suction catheter. The articulated bougie with syringe due to its simplicity is easily understood and this makes it easily accepted. Due to the syringe, we can hold the bougie and the syringe together with one hand and at the same time raise the plunger without the need of the presence of an assistant.

Description

DESCRIPTION

ARTICULATED BOUGIE WITH SYRINGE

The present invention relates to a modified disposable modular tracheal tube introducer -bougie, made of materials present in an operating room and which greatly facilitates the patient's endotracheal intubation.

Before proceeding with the description of the invention it would be useful to refer to some terms which will aid in its understanding.

Endotracheal intubation: is the procedure to insert a flexible tube into the airway (trachea) through the mouth or the nose.

The endotracheal tube is most often placed through the mouth, especially in emergencies. To achieve this using a conventional curve blade laryngoscope and successfully visualize the larynx, one must align three (oral, pharyngeal, and laryngeal) anatomic axes.

Endotracheal tube: is a flexible plastic tube that is placed through the mouth into the trachea to help a patient breathe. The endotracheal tube is then connected to a ventilator, which delivers oxygen to the lungs.

Difficult laryngoscopy: is inability to view the glottis opening using a conventional curve blade laryngoscope, in which only epiglottis or only pharynx and tongue, respectively, may be visualized.

Difficult intubation: is 'an intubation during which the insertion of the endotracheal tube takes more than 10 min, and/or requires more than three attempts by an experienced anesthesiologist_and / or by means of ancillary means.

The tracheal tube introducer -Bougies: are long, stiff plastic wands. Some types have a central lumen for ventilation. They are inserted into the trachea through the glottis during direct laryngoscopy, providing a "guidewire" over which an endotracheal tube can then be more easily advanced into the trachea. It is a tool to assist with the placement of an endotracheal tube in cases where an optimal view cannot be obtained on direct laryngoscopy after lifting the head, performing extra laryngeal manipulation, or both. The tracheal tube introducers or bougies are widely used for facilitating airway management in difficult circumstances. They are easy to use, relatively inexpensive and have success rates of > 90% in most settings. The use of bougies has expanded over the years, and they are now used to aid insertion of supraglottic airways (SGAs) and video laryngoscope-guided intubation.

The Stylets: are rigid or semi-rigid airway adjuncts that are inserted into the tracheal tube before intubation. They maintain the tracheal tube in a particular shape usually into a hockey stick shape and may therefore assist during intubation. The stylet also provides additional rigidity to the tube which may aid in tube passage.

Fiberoptic intubation: is an effective technique for establishing airway access in patients with a difficult intubation. First described in the late 1960s, this approach can facilitate airway management in a variety of clinical scenarios.

Video laryngoscopy: is a relatively new technology developed to improve the success rate of tracheal intubation. A high-resolution micro camera mounted on the tip of a curved blade connected to small portable digital monitor improves the view of the vocal cords and subsequently the success rate of direct laryngoscopy. The use of video laryngoscopes has helped significantly in the treatment of this difficulty since the vision of the laryngeal inlet does not presuppose the alignment of the three anatomic axes but the same does not happen with the placement of the tube. In most cases, the use of specific techniques and tools is necessary for this installation.

The main indications for tracheal intubation are:

• Establishment of a patent and protected airway

• Support for ventilation and oxygenation

• The administration of anesthesia for surgery

Airway management is of paramount importance for safety when administering anesthesia, because the most serious problems associated with it concern or involve the airway.

Also, the management of a difficult airway is a stressful process because the ventilation, the oxygenation and therefore the life of the patient is in danger. Often, the anesthesiologist must manage this situation on his own without specialized help (doctor or nurse anesthetist) and as soon as possible.

During the management of this critical situation the anesthesiologist operates based on protocols and uses specific anesthesia equipment (machines and tools). Mainly at night, where the operating units function with reduced staff, it is not always easy to find specialized tools. That may happen because either they may have been already used and not sterilized or because they have not been replaced and repositioned in the trolley of the anesthesiologist, or simply because they may be positioned at a considerable distance far from where the anesthesiologist is located.

During airway management the time is valuable for the patient's life. This makes it imperative that the tools should be of low cost so that they may exist in all operating rooms. Their use should be easily understandable without necessitating any special skills so that they can be used at critical times, where the anesthesiologist's stress is high.

The search for a simple, low cost and at the same time user-friendly tool was the logical reasoning for the construction of this modular bougie.

To ensure simplicity, it is made of materials that already exist in the operating room (the bougie, the suction catheter, a surgical thread, and a syringe) with the use of which not only the anesthesiologist but also all the surgery staff are familiar. All doctors know what to do with the syringe and how to handle it. When a device is easily understandable, it is also easily accepted. Many techniques or tools that in normal conditions seem easy, in case of crisis their application or use becomes many times more difficult. For this reason, components with crucial function for the machines have not changed at all over the centuries, such as the steering wheel. The same steering wheel that navigators used in previous centuries to navigate their ships, the same is used today to navigate the modern ships but also cars and even some airplanes. This is because even since childhood we are familiar with how to use it and its use is now automatic without any further thought process.

As already mentioned, the difficult endotracheal intubation is the inability of the endotracheal tube to be placed correctly in the trachea, which is usually due to the difficulty of alignment of the three (oral, pharyngeal and laryngeal) anatomic axes.

In conventional bougies the lower end is convex 30 °, which allows to overcome, up to a certain point, this difficulty. However, it is not possible to use them when the angle between the pharynx and the larynx is greater than 30 °, something that is only possible with the bronchoscope due to its flexible lower extremity. Due to the change in the curvature of the final tip, it is easier and quicker in its way of manipulations and straightening of the pharynx with the laryngeal axis.

The present invention to be described, makes use some of the advantages of the bronchoscope but its principle is that it applies to a disposable and a low-cost device that is much simpler and easier to use.

There certainly exist other bougies with a flexible tip. However, they do not use the syringe to lift the lower limb and they are based on complex mechanisms which makes them much more difficult to understand and to use.

More specifically:

A. The bougie with a controllable tip WO2015/066763 A1.

1 . It does not use the lifting of the syringe plunger for bending the tip, but it uses lateral projections.

2. For the bending it does not use a surgical thread, but it uses a control rod.

3. The components of which it consists of do not exist in the operating room.

4. The use of lateral projections instead of the syringe makes the grip of the bougie different than the grip of the articulated bougie with syringe.

B. The adjustable stylet for endotracheal tube US 2007/0287961 A1

1 .The adjustable stylet is a stylet, something completely different from a bougie. The stylet is shorter and harder so to enable the bending of the tube but in this way, it eventually becomes more traumatic. 2 .This stylet provokes selectively a varying curvature of the endotracheal tube into which the stylet is to be received, but the articulated bougie with syringe can bend, just its distal end and not the tube.

3.The stylet is comprised of a pair of elongated plastic, flexible members joined at their distal ends while the articulated bougie with syringe consists of a bougie with a central lumen, a syringe, a suction catheter, and a surgical thread.

4.The only thing that may look similar is the shape of the syringe plunger with the shape of thumb button but in the case of the bougie, the bougie relates to a surgical thread whereas we must pull the syringe plunger while in the stylet the thumb button must be pressed to push consequently the rigid plastic members.

5.Obviously, the components of which it consists of do not exist in the operating room.

C. The bougie for facilitating an intubation PCT/AU2015/050047.

1 .According to claims « the handle is a spring handle operated by a trigger, wherein the handle is integrated a cam and spring mechanism connected to a button that pulls the cable or cords when the button is pressed». Therefore, the traction mechanism is completely different from the articulated bougie with syringe, where the traction of the distal end is achieved due to the lifting of the syringe plunger.

2.According to claim 2 and the figures, «wherein said flexible region comprises a spring.» in its distal end. In the articulated bougie with syringe there is no spring in the distal flexible end. 3. The components of which it consists of do not exist in the operating room.

The advantages of the invention of the articulated bougie are the following:

• This is an articulated bougie that due to the syringe, offers the possibility of vertical bending of its distal end by lifting its piston, which is located at its proximal end (DRAWING No. 2). Thus, we can change the angle of the end of the bougie, like the tip of the bronchoscope, something very important in cases of difficult intubation.

• The articulated bougie with syringe is made of materials that we find in an operating room. This gives it the advantage of being easily understood and familiar to anesthesiologists. Most anesthesiologists are usually skeptical of new devices and find it difficult to change their habits. But this device has nothing new and nothing to hide. On purpose, it is made by using materials that can be easily found in the operating room, such as a bougie, a suction catheter, a surgical thread, and a syringe. All doctors know what to do with the syringe. When a device is easily understood is also easily accepted.

• Due to the syringe, we can hold the bougie and the syringe together with one hand and at the same time raise the plunger without the presence of an assistant.

• The mechanism is simple and so the fabrication becomes also cheap.

• The training in its use is easy, since the only mobile point of the device is the syringe plunger.

• It is a single- use device. The articulated bougie with syringe for endotracheal intubation as shown in FIGURE No.1 consists of materials that we can find in an operating room:

1 .A syringe consisting of a plunger and a barrel, is located at the proximal end of the bougie.

2. The connection, which is made of a suction catheter, joins the needle adapter of the syringe to the bougie.

3. A bougie with a central hollow lumen through which the surgical thread passes.

4. An inelastic surgical thread that goes through the bougie and connects the syringe plunger to the distal tip of the flexible end.

5. A flexible distal end made of a conventional suction catheter while the proximal end is joined to the bougie and the distal end to the surgical thread.

The articulated bougie with syringe is not inferior to the simple bougie, but on the contrary it has additional features.

The lifting of the syringe plunger, and the induced movement of the thread, causes the lifting of the distal tip, which is very important in cases of difficult intubation as already mentioned.

This invention is useful in the following cases:

• in cases of difficult intubation where it is difficult to straighten the angle formed by the pharynx with the laryngeal axis.

• in the intubation with video laryngoscope where we can see the laryngeal inlet, but we cannot direct the endotracheal tube into the trachea.

• for the installation of a double lumen tube.

Claims

1 The articulated bougie with syringe for endotracheal intubation consists of materials that can be found in an operating room: A syringe (1) consisting of a plunger and a barrel. On the needle adapter of the syringe, there is an adapted connection (2) made by a suction catheter, which joins the needle adapter of the syringe with the proximal end of the bougie (3) which has a central hollow lumen along its entire length, through which passes a surgical thread (4), which joins the plunger of the syringe with the distal tip of the flexible end. The distal end of the bougie is joined to the proximal end of the flexible end (5) of the device and is made of a conventional suction catheter.

2 The articulated bougie with syringe for endotracheal intubation according to claim 1 is characterized by the following properties which comprise the act of the lifting of the plunger and at the same time the induced movement of the thread, resulting easily in this way in the bending of the flexible lower end.

3 This articulated bougie with a lower extremity according to claim 1 allows its safe operation with the use of one hand without necessitating the presence of an assistant (physician or anesthesiologist) and in this way it makes it very useful in the management of the airway in cases of difficult intubation.