WO2023047391A1

WO2023047391A1 - Endotracheal tube with interior multi-layered sputum-collecting sheath

Info

Publication number: WO2023047391A1
Application number: PCT/IB2022/061744
Authority: WO
Inventors: Mehdi REZAEE; Banafsheh MASHAK; Omid MOHAMADZADEH; Seyed Yasin TABATABAEIMEHR; Alborz University of Medical Sciences ABZUMS
Original assignee: Rezaee Mehdi
Priority date: 2022-10-19
Filing date: 2022-12-04
Publication date: 2023-03-30

Abstract

The present disclosure describes a tracheal tube assembly (1) and a incorporating a scavenging system ( 3) for collecting secretions and clots made up of three disposable plastic layers (4, 5 and 6) embedded onto the internal surface of the endotracheal tube (2) lumen that lay upon each other. Each layer (4, 5 and 6) is associated to a layer-specific indicator (13, 14 and 15, respectively) outside the tube (2) inlet (16) through a layer-specific band (7, 8 and 9, respectively). The bands (7, 8 and 9) thereof extends medially through the length of respective foregoing layers (4, 5 and 6, respectively) from the proximal end of the tubular body (2) inlet (16) to terminate at the distal end of the said layers (4, 5 and 6) within the tube outlet (17) with a tight juncture (10, 11 and 12, respectively). The innermost layer is pulled up one by one when necessary to remove the intraluminal secretions. By pulling the inner layer's band upon the time which secretions and clots accumulate, it will extract them from the tube, and there will be no more need for re-intubation which results in decrease of unwanted hazards of re-intubation.

Description

Title of Invention: Endotracheal tube with interior multi-layered sputumcollecting sheath

FIELD OF THE INVENTION

[001] The present invention relates to medical devices, and more particularly, to a tracheal tube including a scavenging coating therein.

BACKGROUND OF THE DISCLOSURE

[002] This section is intended to introduce the reader to various aspects of art that may be related to various aspects of the present disclosure, which are described and/or claimed below. This discussion is believed to be helpful in providing the reader with background information to facilitate a better understanding of the various aspects of the present disclosure. Accordingly, it should be understood that these statements are to be read in this light, and not as admissions of prior art.

[003] One of the fundamental responsibilities of the anesthesiologist is to mitigate the adverse effects of anesthesia on the respiratory system by maintaining airway patency and ensuring adequate ventilation and oxygenation. The term airway management refers to this practice and is a cornerstone of anesthesia. Tracheal intubation is the gold standard for airway management. It establishes a definitive airway, provides maximal protection against the aspiration of gastric contents, and allows for positive pressure ventilation with higher airway pressures. The endotracheal tube is a hollow plastic tube inserted into the patient's trachea for mechanical ventilation and is connected to a ventilator. Endotracheal tubes can be placed in patients who are unable to effectively maintain life-sustaining ventilation and respiration on their own. The institution of mechanical ventilation can result in increased production of secretions within the patient's native airways and accumulation of those secretions within an artificial airway such as an endotracheal tube. Patient’s receiving ICU care need an endotracheal tube for long durations, which may get clogged by secretions and clots that leads to life-threatening occlusion of the endotracheal tube or at least increased work of breathing, which may result in increased difficulty in weaning, and prolonged mechanical ventilation and intensive care unit stay. Therefore, there is a need to frequently change the tracheal tube for preventing this incident which poses serious problems for the patient and the healthcare system. Complications associated with extubation include laryngospasm and bronchospasm, upper airway obstruction, hypoventilation, hemodynamic changes (hypertension, tachycardia), coughing and straining leading to surgical wound dehiscence, laryngeal or airway edema, negativepressure pulmonary edema, paradoxical vocal cord motion, arytenoid dislocation and aspiration. Re-intubation provokes airway reflexes and gives rise to hypoxia, aspiration of gastric contents and hemodynamic instability. Additionally, intermittent suctioning of the trachea is not capable of removing all debris and leads to hemodynamic consequences and transient periods of hypoxia. Intermittent reintubations impose an extra cost for the healthcare system. Re-intubation needs a team of specialized personnel who also should take care of other patients in the intensive care unit. This leads to a delay in treating other patients and decelerates the healthcare providers, who can use that extra time to do the work of other patients.

[004] An improved design of tracheal tube with removable intraluminal coating helps us to save the time and reduce complications in this regard. A multi-layered scavenging sheath may be coupled to the endotracheal tube to remove the pooled secretions and other debris within the endotracheal tube in a timely manner. Therefore, we designed a new tracheal tube to incorporate a suction-free evacuation assembly to overcome such problems. Taken together, we employed several intraluminal disposable plastic layers placed upon each other to collect the secretions and clots that can obstruct the tube to eliminate the need for the tube exchange.

[005] According to the research done in the online resources and general search in the search engines, we found no similar design to this innovation to date.

SUMMARY OF THE INVENTION

[006] An object of the present disclosure is to provide a tracheal tube having an evacuation assembly which can remove intraluminal secretions in a tracheal tube of a patient out of the lumen to eliminate the necessity for tube exchange of an obstructed tube in emergent situations.

[007] Due to the fact that in patients with prolonged intubation, the use of endotracheal tube carries the risk of clot formation leading to sudden airway obstruction this type of endotracheal tube is aimed to resolve corresponding issues by giving rise to intraluminal evacuation of secretions and debris through a scavenging assembly.

[008] Accordingly, a tracheal tube of this disclosure includes the combination of an airway tubular body and an intraluminal multi-layered coating to scavenge undesired luminal obstructing pooled secretions and debris. The airway tubular body extends along a lengthwise axis to terminate at an upstream gas inlet end and a downstream gas outlet end. The downstream gas outlet end is suitable for placement in a trachea of a patient. The upstream gas inlet end is suitable for placement at a region adjacent to an exterior of the patient. The scavenging assembly mounted inside the tubular body extends to both ends thereof to form a hallow lumen adapted to the diameter of the tracheal tube. The intraluminal coating of tracheal tube is composed of multiple thin disposable plastic layers laid upon each other. A layer-specific indicator for each layer outside of the upstream inlet thereof is connected to the distal portion of respective layer at the level of downstream outlet thereof through a label-specific band which passes the length of said tubular body medial to the corresponding layer. Pulling up the innermost layer-specific band results in inversion of the distal edge of corresponding layer to collect intraluminal secretions and ultimately absolute removal of secretions by thorough extraction of said layer. The use of this endotracheal tube mitigates adverse airway outcomes and rescues time and resources by eliminating the need for replacing a tracheal tube.

[009] As disclosed is multiple layered sheath that couple to the existing tracheal tube where the layers are removed one by one manually when necessary to evacuate secretions for a more efficient ventilation.

BRIEF DESCRIPTION OF THE DRAWINGS [010] FIG. 1 illustrates a diagrammatic perspective view of an endotracheal tube with an intraluminal scavenging system assembly mounted inside tubular body extended to both ends thereof; and

[011] FIG. 2 is a perspective view of the scavenging system assembly.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[012] In order to make the objects, technical solutions and advantages of the present invention clearer, the present invention will be described in further detail below with reference to the accompanying drawings and examples.

[013] A common problem in airway management of patients with prolonged intubation during long stay in intensive care units is impairment of mucus drainage through tracheal tube devices which in turn necessitates intermittent suctioning of undesired pooled luminal secretions and in some cases replacement of the tube which may result in devastating consequences. Thus it is imperative that a less invasive approach be implemented in the new modification of the tube (1 ) with scavenging capability in highly susceptible patients.

[014] To solve the technical problems presented here, we must prevent hemodynamic consequences provoked by excessive pain stimuli during emergent tube replacement and suctioning of the trachea. The mechanism by which scavenging of intraluminal clots is facilitated is embedding a thin multi-layered intraluminal plastic sheath (3) in the tracheal tube (2) which consists of multiple disposable layers (4,5 and 6) to eliminate the need for replacing the tracheal tube by retrieving the disposable plastic layers 4,5 and 6) one by one anytime an indication for tube exchange appears due to obstructing agents.

[015] The sheath (3) consists of three cylindrical disposable plastic layers (4,5 and6) placed upon each other that cover the inner surface of the tube (2). Each of the layers (4, 5 and 6) has an individual identification label (13,14 and 15, respectively) outside of the tube (2) inlet (16), and each labell 3, 14 and 15) is associated to the respective layer through a band (7, 8 and 9, respectively). The bands (7, 8 and 9) thereof extends medially through the length of respective foregoing layers (4, 5 and 6, respectively) from the proximal end of the tubular body (2) inlet (16) to terminate at the end of the said layers (4, 5 and 6) within said tube outlet (17) with a tight juncture (10, 1 1 and 12, respectively). Consecutive pulling of these bands (7, 8 and 9, respectively) inverts the edge (10, 11 and 12, respectively) of respective layer (7, 8 and 9, respectively) into the lumen of the tracheal tube (2) which results in extraction of corresponding layer internally whenever removal of obstructing secretions and clots is required, thus eliminating the need for occluded tube exchange for the first, second and third times.

[016] The innovative design of this invention prevents autonomic reflexes of the orotracheal tract and hemodynamic compromise induced by painful stimuli during orotracheal tract suctioning or tube exchange with carrying the least risk of hypoxia whilst a reduction in time, resources and personnel is presumable.

[017] The design of the apparatus (1 ) is based on a primary sample of the tracheal tube (2), which has several cylindrical inner covering layers (4,5,6) placed upon each other, and a band (7,8,9) is attached to each layer at the distal portion. By pulling the innermost band (7) respective to the label number (13), it will be extracted like a sack and will collect the luminal secretions of the tracheal tube. Then, the secretion-free tube with the remaining layers (5 and 6) and bands (8 and 9) is reconnected to the ventilator.

[018] While the disclosure may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail herein. However, it should be understood that the embodiments provided herein are not intended to be limited to the particular forms disclosed. Rather, the various embodiments may cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure as defined by the following appended claims. In addition, all the disclosed embodiments may be fabricated in different sizes and configurations to accommodate differences in the age or anatomy of the patient population.

THE ADVANTAGES OF THE INVENTION OVER THE PREVIOUS MODELS

[019] - Limited attempts for multiple tries for intubation of difficult airways in need of tube exchange [020] - Reduced incidence of failed re-intubation

[021] -Less need for advanced airway equipment

[022] - Efficient management of time and resources

[023] -Decrease in adverse airway outcomes

[024] -Decline in morbidities and mortalities associated with emergent airway situations

[025] -Reduced technical complexities

INDUSTRIAL APPLICABILITY OF THE INVENTION

[026] The industrial application of this invention is in the field of medical equipment production. end

Claims

7 Claims

[Claim 1] A tracheal tube assembly (1 ) with provision for collecting the accumulated secretions inside the tube comprising: a. A hollow cylindrical plastic tube (2) with a constant diameter proportional to age having a proximal end and a distal end, wherein the proximal end (16) of the tube being configured to include an adaptor to connect the tube to a ventilation device that provides an air/oxygen mixture or anesthetic to the patient through the tube and the distal portion (17) of said tube is inserted into the trachea; and b. multi-layered cylindrical disposable sheath (3) embedded inside the tracheal tube lumen extended to both interior ends (16 and 17) of the tracheal tube (2) to fit the tracheal tube diameter.

[Claim 2] The collecting assembly (3) as defined in claim 1 further comprising: a. Three cylindrical disposable plastic layers (4, 5 and 6) placed upon each other, which cover the inner surface of the tube. b. An individual identification label (13, 14 and 15) for each layer (4, 5 and 6, respectively) outside the tube. c. Label-specific bands (7, 8 and 9) for each layer (4, 5 and 6, respectively) to connect said layers to the corresponding labels (13, 14 and 15), respectively.

[Claim 3] The label-specific bands (7, 8 and 9) of the claim 2 continues from the proximal end to the distal end of the medial side of the respective layers (4, 5 and 6) to grip distal portion (10, 11 and 12, respectively) of said layers (4, 5 and 6, respectively).