The present invention, in some embodiments thereof, relates to medical delivery tubes and, more particularly, but not exclusively, to endotracheal tubes and a method of using and producing thereof.
An endotracheal tube (also called an ET tube or ETT) is used in general anaesthesia, intensive care and emergency medicine for airway management, mechanical ventilation and as an alternative route for many drugs if an IV line cannot be established. The tube is inserted into a patient's trachea in order to ensure that the airway is not closed off and that air is able to reach the lungs. The endotracheal tube is regarded as the most reliable available method for protecting a patient's airway.
Ventilator-associated pneumonia (VAP) is a common complication which occurs when ETT is used; aspiration of bacteria colonized secretions across the endotracheal tube cuff into the lower airways is a major risk factor for VAP. Such aspiration occurs along longitudinal folds formed when the high-volume low-pressure endotracheal tube cuff is inflated in the trachea.
During the last years various solutions have been developed for reducing or avoiding VAP. For example, U.S. Patent Application No. 2009/0107510, filed on Oct. 29, 2007 describes a novel two-layer endotracheal tube (ETT) cuff for the prevention of pneumonia is disclosed. The disclosed two-layer ETT comprises a standard HVLP cuff covered with a second layer of elastomeric material with a sterile gel inserted between the layers. The two-layer cuff forms no folds when inflated in the trachea and prevents leakage, substantially reducing the risk for pneumonia attributable to standard ETT cuffs.
Another solution is described in U.S. Pat. No. 5,725,510, filed on Feb. 21, 1996 which describes an endotracheal tube with a collar. In order to avoid as far as possible the danger of a pulmonary infection caused by microbes introduced along the tube, at least one device with an antimicrobial action is fitted at one or more points on the outer surface of the tube. This device consists preferably of a piece of silver foil, vapor-deposited silver or a silver compound (silver salt), or may also be a length of tubing fitted in the tube.
According to some embodiments of the present invention, there is provided an endotracheal device. The endotracheal device comprises an endotracheal tube sized and shaped for being disposed within the trachea so that at least a distal segment thereof being placed in the lumen of the windpipe of a patient and at least one self expending element disposed around a peripheral surface of the endotracheal tube and having a first thickness in a compressed state and a second thickness in an expanded state, the at least one self expending element switching from the compressed state to the expanded state when absorbing moisture. The first thickness is thinner than the second thickness.
Optionally, the at least one self expending element having a disc shaped structure around the endotracheal tube when in the expanded state.
Optionally, the at least one self expending element comprises at least one of compressed cellulose and Polyvinyl acetate (PVA).
Optionally, the second thickness is at least ten folds thicker than the first thickness.
Optionally, the at least one self expending element is at least partly soaked with a dissolvable material so as to allow the slowing down of its expending rate.
Optionally, the endotracheal device further comprises a suction unit for applying a suction force for drawing biological fluids accumulated in the trachea, above the at least one self expending element.
More optionally, the suction unit having a plug for transmitting the suction force from an external source to a space above the at least one self expending element, in proximity to the endotracheal tube.
More optionally, the suction unit having a mechanical valve for timing the applying, the mechanical valve being operated by the suction force.
More optionally, the endotracheal device further comprises at least one sensor for detecting at least one of a presence and an absence of biological fluids above the at least one self expending element, in proximity to the endotracheal tube, the suction unit being operated according to at least one of the presence and the absence.
More optionally, the endotracheal device further comprises a suction timing unit for timing the operation of the suction unit.
More optionally, the endotracheal device further comprises the suction timing unit having a mechanic valve for timing the applying.
More optionally, the endotracheal device further comprises the suction timing unit having a solenoid based valve for timing the applying.
More optionally, the endotracheal device further comprises the timing is performed in every preset period.
More optionally, the endotracheal device further comprises a suction indication unit for indicating whether the suction force is applied.
Optionally, the endotracheal tube is sized and shaped for passing via an incision in the trachea.
Optionally, at least one self expending element is circularly disposed around the peripheral surface.
More optionally, the endotracheal device further comprises a built in peristaltic pump for applying a suction force for drawing biological fluids accumulated above the at least one self expending element.
According to some embodiments of the present invention, there is provided a method of at least one of performing an endotracheal procedure. The method comprises providing an endotracheal tube having an inner lumen at least one self expending element disposed around a peripheral surface thereof, the at least one self expending element having a first thickness in a compressed state and a second thickness in an expanded state, the at least one self expending element switching from the compressed state to the expanded state when absorbing moisture, disposing the endotracheal tube within the trachea so that a distal segment thereof being in a trachea lumen of a patient, allowing the at least one self expending element to absorb biological fluids so as to change from the compressed state to the expanded state in the windpipe trachea lumen, and using the inner lumen for performing the endotracheal procedure.
Optionally, the endotracheal procedure is a member of a group consisting of a diagnostic procedure, a breathing procedure and a treatment of a trachea or the lungs, for example medicament injection.
According to some embodiments of the present invention, there is provided a blocking element of an endotracheal tube. The blocking element comprises a supporting member having an aperture sized for closely receiving an endotracheal tube and at least one self expending element coupled to the supporting member so as to be circularly disposed around a peripheral surface of the endotracheal tube. The at least one self expending element having a first thickness in a compressed state and a second thickness in an expanded state, the at least one self expending element switching from the compressed state to the expanded state when absorbing moisture.
According to some embodiments of the present invention, there is provided a endotracheal device that comprises an endotracheal tube sized and shaped for being disposed within the trachea so that at least a distal segment thereof being placed in the windpipe lumen of a patient and at least one flexible and absorbent element each disposed around a peripheral surface of the endotracheal tube so as to project outwardly and extend the cross section area thereof.
Optionally, the at least one flexible and flexible and absorbent element changes thickness when absorbing moisture.
Optionally, the at least one flexible and flexible and absorbent element is made of spongy material.
Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.
Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced. In the drawings:
The present invention, in some embodiments thereof, relates to medical delivery tubes and, more particularly, but not exclusively, to endotracheal tubes and a method of using and producing thereof.
According to some embodiments of the present invention there are provided methods and endotracheal devices, such as a respiratory tube, a mechanical ventilation device having a respiratory tube, a lung probe conducting tube, and a medicament conducting tube. The tube has self expending elements for blocking body fluids or feeding fluids, such as saliva from passing to the lung during diagnosis, respiration, mechanical ventilation, and/or treatment of a patient via the trachea using one or more self expending elements, which are optionally expend when absorbing moisture. It should be noted that the term self expending element is used to described herein any flexible and absorbent element, such as flexible and absorbent element made of a spongy material or any element that changes thickness when absorbing moisture. Optionally, the endotracheal device includes endotracheal tube sized and shaped for being disposed within the trachea so that at least a distal segment thereof is placed in the windpipe lumen of a patient. The tube of the device, which may be a mechanical ventilation device, further includes one or more self expending elements disposed around, optionally a peripheral surface of the endotracheal tube and having a compressed state and an expanded state. The self expending elements optionally switches from the compressed state to the expanded state when absorbing biological fluids, such as saliva, food, feeding fluids, and blood or can already be disposed expended in body lumen, such as the trachea. The thickness in an expanded state is thicker than in a compressed state so that the gap between the inner walls of the trachea and the peripheral surface of the endotracheal tube at the respective cross section is sealed and/or substantially closed. Optionally the seal can be coated with bacteriostatic material for the prevention of infection in the trachea. Optionally, the expending elements are coated with lubricants. Optionally, a suction unit operated periodically and/or according to the reading of one or more sensors, is used for draining the saliva, blood, food, and/or feeding fluids from the trachea.
Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth in the following description and/or illustrated in the drawings and/or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.
Reference is now made to
The endotracheal device 100 includes an endotracheal tube 101 having an inner lumen for respiration and/or delivering medications or for diagnostic purposes (probe). The endotracheal tube 101 is defined herein as any commonly used endotracheal tube, for example a respiratory tube of a mechanical ventilation system, a lung diagnosis catheter, and a medicament conducting tube. The endotracheal tube 101 may be used for guiding probes and/or sensors for lung or trachea diagnosis, for example imaging sensors borescope. The endotracheal tube 101 is sized and shaped for being disposed within the trachea so that a distal segment thereof is placed in the windpipe lumen of a patient. Optionally, the endotracheal tube 101 comprises a small diameter flexible tube preferably made of transparent plastic, such as polyvinyl Chloride or silicone. The length of the endotracheal tube 101 is adjusted to the size of the patient. For example, an endotracheal device for adult patients has an endotracheal tube 101 of more than 30 centimeter long and 1 cm diameter for and an endotracheal device for infants has an endotracheal tube 101 of more than 20 centimeter long and 0.5 cm diameter.
The endotracheal device 100 further comprises one or more self expending elements 102 placed to encircle, optionally substantially horizontality, an annular portion of the surface of the endotracheal tube 101, substantially perpendicularly to the main longitudinal axis 111 of the endotracheal tube 101. Each self expending element 102 may include one or more segments which encircle, at least substantially, a cross section of the endotracheal tube 101. For example a number of segments may be disposed around a common plane one to the side of the other and/or in parallel planes, one above the other.
In use, the self expending elements 102 are set to expand in the trachea, blocking saliva, blood, food, and/or feeding fluids from dripping into the lungs volume. The self expending elements 102 have at least two states, a compressed state and an uncompressed expanded state. When the self expending element(s) 102 are in a compressed state, the endotracheal device 100 may be guided via tubular lumens having a limited diameter, such as the trachea, without applying damaging pressure on the inner walls. However, when the self expending element(s) 102 are in an expanded state, their diameter increases and a flexible is created for the tubular lumen.
Optionally, the self expending element 102 is made of a biocompatible material such as crystal violet—A dye derived from gentian violet that is used as a general biological stain, an acid-base indicator, and an agent against infection by bacteria, fungi, pinworms, and other parasites. The biocompatible material is optionally porous, which expands when it absorbs biological fluids, for example the material is a spongy material, such as compressed cellulose and Polyvinyl acetate (PVA) or polyvinyl formal (PVF) that is manufactured from PVA by reaction with butyraldehyde. Optionally, the self expending element 102 is between about 0.2 mm thick and about 2 mm thick in a compressed state and about ten time thicker in an expanded state, for example when exposed to moist or biological fluids. Each self expending element 102 is optionally shaped as a tube and coupled on a peripheral surface of the endotracheal tube 101 so that expands the diameter at a certain cross section thereof. In such an embodiment, the compressed state is achieved when the porous martial is in a non absorbed state and the expanded state is achieved when the porous martial is absorbed with biological fluids.
The resulting shape of the self expending element 102 in an expended state approximates a tube or a cylindrical roll, expanded in size with respect to its compressed, non-absorbed state. Optionally, the self expending element 102 is comprises of a number of annular layers which are appended, one on top of the other. Different layers may have different expansion factor when exposed to biological fluids.
In use, at least a portion of the endotracheal device 100 is inserted through the nasal or oral cavity, passing through at least part of the trachea and terminating in the windpipe lumen. For example, when the endotracheal device 100 is a respiratory endotracheal device, the placing of the distal end of the endotracheal tube in the windpipe lumen allows direct ventilation to the lungs, via the inner lumen of the endotracheal tube 101.
The self expending element 102, which is optionally placed at the distal segment of the endotracheal device 100, functions as a seal, for example as shown at
Optionally, the self expending element 102 is wetted before the disposing of the device 100 in the trachea so as to reduce it's rigidify and/or to reduce its expansions time.
In use, the expanded state, the self expending element 102 fills the gap between the endotracheal tube 101 and the esophageal walls, preventing from some or all of the saliva, blood, food, and/or feeding fluids to pass from the trachea to the lungs. Such a self expending element 102 is passive, allowing sealing or substantially closing off the trachea passage without using actuating means.
According to some embodiments of the present invention, the self expending element 102 is at least partly soaked with a dissolvable material so as to reduce its expansion rate, or any other polymeric material to be used as a sleeve. For example, a gelatin base material or any other dissolvable material that withholds the self expending element 102 from absorbing the biological fluids when placing the endotracheal tube 101 in the trachea of the patient is applied. In such a manner, the self expending element 102 remains in a compressed state for a locating period in which the user can easily locating the endotracheal tube 101 in the trachea. The gelatin base material dissolves after a couple of minutes when the endotracheal tube 101 is in place in the trachea 103. During the locating period the operator introduces the endotracheal tube easily and comfortably with no excessive friction. After the endotracheal tube 101 is in proper position and the compressed self expending element 102 is in the lower portion of the trachea, the gelatin dissolves and the self expending element 102 absorbs the, blood, and/or feeding fluids from the surrounding and as an outcome expends.
It should be noted when the self expending element 102 absorbs fluids, it soften and becomes more elastic. This facilitates the removing thereof.
Optionally, as shown at
It should be noted that the endotracheal device 100 may be adjusted for tracheotomy and/or tracheostomy, as shown at
Reference is now made to
The valve disc 701 is placed in a cross section of a suction force conduit 705 which connects between the tip of the suction source tube 608 and the suction source 606. The gear 702 is set to rotate the valve disc 701, which is optionally shaped with a suction force opening segment 801 and a blocking surface segment 802, as depicted in
Additionally or alternatively, the suction force may be applied according to the reading of one or more sensors, such as impedance sensors. In such an embodiment, the suction timing unit 605 receives the reading of the impedance sensors and operates a suction force valve and/or the suction source 606 accordingly. The suction timing unit 605 may be operated by batteries and/or external AC power. Optionally, the suction timing unit 605 has a plug adapted to the suction source 606 socket of a hospital and/or an ambulance and/or a hospitalization facility. Drainage may be done manually with a syringe connected to the tube for example.
Reference is now made to
Reference is now made to
Reference is now also made to
One or more self expending elements 102, as shown at
Now, as shown at 1202, the endotracheal tube is disposed within the trachea so that a distal end thereof is in the windpipe lumen of a patient, for example as shown at
It is expected that during the life of a patent maturing from this application many relevant devices and methods will be developed and the scope of the term sensor is intended to include all such new technologies a priori.
As used herein the term “about” refers to ±10.
The terms “comprises”, “comprising”, “includes”, “including”, “having” and their conjugates mean “including but not limited to”. This term encompasses the terms “consisting of” and “consisting essentially of”.
The phrase “consisting essentially of” means that the composition or method may include additional ingredients and/or steps, but only if the additional ingredients and/or steps do not materially alter the basic and novel characteristics of the claimed composition or method.
As used herein, the singular form “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.
The word “exemplary” is used herein to mean “serving as an example, instance or illustration”. Any embodiment described as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments and/or to exclude the incorporation of features from other embodiments.
The word “optionally” is used herein to mean “is provided in some embodiments and not provided in other embodiments”. Any particular embodiment of the invention may include a plurality of “optional” features unless such features conflict.
Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging/ranges between” a first indicate number and a second indicate number and “ranging/ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.
As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.
It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.
Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.
All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/IL11/00101 | 1/27/2011 | WO | 00 | 9/19/2012 |
Number | Date | Country | |
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61340622 | Mar 2010 | US | |
61365399 | Jul 2010 | US |