Not applicable.
1. Field of Invention
The invention relates generally to the field of medical devices, e.g., a medical tube (e.g., an endotracheal tube) including an inflatable cuff. According to various embodiments, the endotracheal tube utilizes the novel ventilator attachment fitting and/or connector as well as a main tube which utilizes an integrally formed suction lumen and also, in embodiments, an integrally formed inflation lumen.
2. Discussion of Background Information
Conventional methods of endotracheal intubation involve the insertion of a tubular device, e.g., an endotracheal tube, into the trachea. The endotracheal tube typically passes through the trachea and terminates above the carina, allowing gases to be directed through the tube and into the lungs.
A primary objective of this type of treatment is the mechanical ventilation of a patient's lungs, which may be required or appropriate due to the subject's medical condition. In order to create the air pressure necessary to artificially ventilate the lungs, the passageways around the tube are typically sealed, which may be accomplished, e.g., using the inflatable cuff. The cuff is typically located within the trachea about 3-5 centimeters above the carina and is then inflated to expand and seal against the wall of the trachea. This prevents gases from being pumped into the lungs from backing up around the tube.
Although cuffed endotracheal tubes perform an important service, they can allow secretions to collect proximate the cuff and provide a site for the possible accumulation of pathogens. Various methods have been devised for removing such secretions. For example, a small opening may be provided above the cuff with an associated suction lumen. Fluids and/or solids (e.g., secretions) can be periodically or continuously removed through the opening and lumen by suction.
It is also known that cuffed endotracheal tubes often do not self-center within the trachea upon inflation of the cuff. As a result, the suction openings of a particular tube may not be spaced apart from the tracheal wall. For example, due to the curvature of the tube and/or other factors, the suction opening may be located very near the tracheal wall upon cuff inflation. In some instances, the suction opening may actually contact the tracheal wall. In such situations, the tracheal wall membrane may be drawn into the suction opening upon application of a vacuum, thereby occluding the opening. This may prevent the proper removal of secretions from the subglottic space and/or may cause trauma to the tracheal wall.
Known endotracheal tubes also incorporate pigtail tubing to connect the cuff inflation lumen to an inflation syringe and a suction lumen to deliver suctioning into the trachea from a suction source. These pigtails typically separate from the main tube at a point below where the main tube is typically cut to fit a particular patient. While the pigtail for cuff inflation is small, the pigtail for suctioning is larger and can cause space issues within the limited space of the patient oral cavity. This is especially the case during, e.g., oral care and inspections.
It would be beneficial to have a main tube include an integrally formed suction lumen and that this suction lumen is configured so that when the main tube is cut, an end of the suction lumen is substantially flush with an end of the inflation lumen. It would also be beneficial to have a connector that can be connected more easily to a main tube of this type, especially after the tube is cut to size or otherwise cut to a length that is tailored to a particular patient.
Accordingly to one non-limiting embodiment of the invention, there is provided a ventilation connector for connecting an endotracheal tube to a ventilation source which overcomes one or more of the deficiencies noted above.
Accordingly to one non-limiting embodiment of the invention, there is provided a ventilation connector for connecting an endotracheal tube to a ventilation source, wherein the connector comprises a body, a ventilation port arranged on the body and being configured to connect to the ventilation source, a suction port arranged on the body and being integrally formed with the body, and an interface portion configured to extend into a proximal end of the endotracheal tube.
The body may be a one-piece plastic body. The connector may further comprise a flange arranged between the suction port and the interface portion. The flange may comprise slots or openings. The flange may be integrally formed with the body. The connector may further comprise a flange arranged between the ventilation port and the interface portion. The flange may comprise oppositely arranged slots or openings. The interface portion may be integrally formed with the body.
The interface portion may comprise at least one of first and second projecting portions, first and second spaced-apart projecting portions, first and second projecting portions projection by different amounts, first and second projecting portions having different axial lengths, first and second projecting portions having different cross-sectional shapes, first and second projecting portions having different cross-sectional sizes, first and second projecting portions having different sized internal passages, and first and second projecting portions having different shaped internal passages.
The first projecting portion may be configured to extend into a ventilation lumen of the endotracheal tube and the second projecting portion may be configured to extend into a suction lumen of the endotracheal tube. The endotracheal tube may comprise an integrally formed ventilation lumen and an integrally formed suction lumen and the interface portion comprises first and second spaced-apart projecting portions. The first projecting portion may be configured to extend into the ventilation lumen of the endotracheal tube and the second projecting portion may be configured to extend into the suction lumen of the endotracheal tube.
The integrally formed ventilation lumen and the integrally formed suction lumen may each have a central axis which is generally parallel to a center axis of the endotracheal tube. The integrally formed ventilation lumen and the integrally formed suction lumen may each have a central axis which is offset from a center axis of the endotracheal tube.
The endotracheal tube may comprise an integrally formed ventilation lumen, an integrally formed suction lumen, and an integrally formed inflation lumen, and the interface portion comprises first and second spaced-apart projecting portions. The first projecting portion may be configured to extend into the ventilation lumen of the endotracheal tube and the second projecting portion may be configured to extend into the suction lumen of the endotracheal tube. The integrally formed ventilation lumen, the integrally formed suction lumen, and the integrally formed inflation lumen may each have a central axis which is generally parallel to a center axis of the endotracheal tube. The integrally formed ventilation lumen, the integrally formed suction lumen, and the integrally formed inflation lumen may each have a central axis which is offset from a center axis of the endotracheal tube.
The endotracheal tube may comprise an integrally formed ventilation lumen, a smaller integrally formed suction lumen, and an even smaller integrally formed inflation lumen, and the interface portion comprises first and second spaced-apart projecting portions. The first projecting portion may be configured to extend into the ventilation lumen of the endotracheal tube and the second projecting portion may be configured to extend into the suction lumen of the endotracheal tube. The integrally formed ventilation lumen, the integrally formed suction lumen, and the integrally formed inflation lumen may each have a central axis which is generally parallel to a center axis of the endotracheal tube. The integrally formed ventilation lumen, the integrally formed suction lumen, and the integrally formed inflation lumen may each have a central axis which is offset from a center axis of the endotracheal tube.
The endotracheal tube may comprise an integrally formed non-circular ventilation lumen, a smaller integrally formed circular suction lumen, and an even smaller non-circular integrally formed inflation lumen, and the interface portion may comprise first and second spaced-apart projecting portions. The endotracheal tube may comprise an integrally formed non-circular ventilation lumen, a smaller integrally formed generally circular suction lumen, and an even smaller oval integrally formed inflation lumen, and the interface portion may comprise first and second spaced-apart projecting portions.
The endotracheal tube may have a generally oval cross-section. The endotracheal tube may comprise an integrally formed non-circular ventilation lumen defining a first lumen cross-sectional area, an integrally formed generally circular suction lumen defining a second lumen cross-sectional area, and a generally oval integrally formed inflation lumen defining a third lumen cross-sectional area.
The endotracheal tube may comprise an integrally formed non-circular ventilation lumen defining a first lumen cross-sectional area, an integrally formed generally circular suction lumen defining a second lumen cross-sectional area, and a generally oval integrally formed inflation lumen defining a third lumen cross-sectional area. The second lumen cross-sectional area may be less than the first lumen cross-sectional area by a factor of between 2 and 5 times, and the third lumen cross-sectional area is smaller than the second lumen cross-sectional area by a factor of between 3 and 10 times. The second lumen cross-sectional area may be less than the first lumen cross-sectional area by a factor of more than 3 times, and the third lumen cross-sectional area is smaller than the second lumen cross-sectional area by a factor of more than 5 times.
The endotracheal tube may comprise an inflatable cuff. The endotracheal tube may comprise a suction opening arranged adjacent the inflatable cuff and between the cuff and the body. The endotracheal tube may comprise a tapered distal end.
The invention also provides for a method for intubation using the connector described above, wherein the method comprises inserting at least a portion of endotracheal tube into a trachea, inflating a cuff of the endotracheal tube, and supplying gas into a patient's lungs via the endotracheal tube.
The method may further comprise suctioning matter through an opening in the endotracheal tube located adjacent the cuff.
The invention also provides for a method of making the connector described above, wherein the method comprises forming the connector as a one-piece member.
The invention also provides for an endotracheal tube assembly comprising a connector of the type described above and which comprises first and second projecting portions and an endotracheal tube comprising an integrally formed ventilation lumen and at least one of an integrally formed suction lumen and an integrally formed inflation lumen. The first projecting portion is configured to extend into the ventilation lumen of the endotracheal tube and the second projecting portion is configured to extend into the suction lumen of the endotracheal tube.
The integrally formed ventilation lumen, the integrally formed suction lumen, and the integrally formed inflation lumen may each have a central axis which is generally parallel to a center axis of the endotracheal tube. The integrally formed ventilation lumen, the integrally formed suction lumen, and the integrally formed inflation lumen may each have a central axis which is offset from a center axis of the endotracheal tube.
The invention also provides for an endotracheal tube assembly comprising a connector of the type described above and which comprises first and second projecting portions and an endotracheal tube comprising an integrally formed ventilation lumen, an integrally formed suction lumen, and an integrally formed inflation lumen. The first projecting portion is configured to extend into the ventilation lumen of the endotracheal tube and the second projecting portion is configured to extend into the suction lumen of the endotracheal tube.
The integrally formed ventilation lumen, the integrally formed suction lumen, and the integrally formed inflation lumen may each have a central axis which is generally parallel to a center axis of the endotracheal tube. The integrally formed ventilation lumen, the integrally formed suction lumen, and the integrally formed inflation lumen may each have a central axis which is offset from a center axis of the endotracheal tube. The integrally formed ventilation lumen may be non-circular and define a first lumen cross-sectional area, the integrally formed suction lumen may be generally circular and define a second lumen cross-sectional area, and the integrally formed inflation lumen may be generally oval and define a third lumen cross-sectional area. The second lumen cross-sectional area may be less than the first lumen cross-sectional area by a factor of between 2 and 5 times, and the third lumen cross-sectional area may be smaller than the second lumen cross-sectional area by a factor of between 3 and 10 times. The second lumen cross-sectional area may be less than the first lumen cross-sectional area by a factor of more than 3 times, and the third lumen cross-sectional area may be smaller than the second lumen cross-sectional area by a factor of more than 5 times.
The invention also provides for a method of making an endotracheal tube, wherein the method comprises cutting a main tube to a desired length and installing a connector on the main tube. The connector and/or main tube may utilize at least one feature described above.
The following description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.
As used herein, the reference terms “proximal” and “distal” (proximal being closer than distal) refer to proximity with respect to a health care professional inserting the endotracheal tube into a patient. For example, the region or section of the endotracheal tube that is closest to the health care professional during insertion is referred to herein as “proximal,” while a region or section of the endotracheal tube closest to the patient's lungs is referred to as “distal.”
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The members 10 and 4 may, in embodiments, be constructed from a suitable polymeric material, such as polyethylene or polypropylene. The components of the assembly disclosed herein can also be made from various well-known materials. The components 10 and 4 can be molded or extruded according to well-known manufacturing techniques.
Materials commonly used to make the member 4 include, but are not limited to thermoplastic elastomers (TPE). In embodiments, materials which are environmentally green in nature and have no extractables can be utilized. Other materials include, but are not limited to natural rubber latexes (available, for example, from Guthrie, Inc., Tucson, Ariz.; Firestone, Inc., Akron, Ohio; and Centrotrade USA, Virginia Beach, Va.), silicones (available, for example, from GE Silicones, Waterford, N.Y., Wacker Silicones, Adrian, Mich.; and Dow Corning, Inc., Midland, Mich.), polyvinyl chlorides (available, for example, from Kaneka Corp., Inc., New York, N.Y.), polyurethanes (available, for example, from Bayer, Inc., Toronto, Ontario, Rohm & Haas Company, Philadelphia, Pa.; and Ortec, Inc., Greenville, S.C.), plastisols (available, for example, from G S Industries, Bassett, Va.), polyvinyl acetate, (available, for example from Acetex Corp., Vancouver, British Columbia) and methacrylate copolymers (available, for example, from Heveatex, Inc., Fall River, Mass.). Natural rubber latexes, polyurethanes, and silicones are preferred materials. Any combination of the foregoing materials may also be used in making catheters. In one embodiment, a rubberize layer that includes latex and a methacrylate is used with build up and finish layers that include latex but not methacrylate. In another embodiment, a polyurethane rubberize layer is used with latex build up and finish layers. In another embodiment, a polyvinyl acetate and latex rubberize layer is used with latex build up and finish layers. Each of the foregoing embodiments in which specific Young's Modulus values are specified may be used with any material.
The invention also provides for a method for intubation using the assembly of
The invention also provides for a method of making a device for intubation shown
The invention also provides for a method of making a device for intubation shown
This invention has been described and specific examples of the invention have been portrayed. While the invention has been described in terms of particular variations and illustrative figures, those of ordinary skill in the art will recognize that the invention is not limited to the variations of figures described. In addition, where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art will recognize that the ordering of certain steps may be modified and that such modifications are in accordance with the variations of the invention. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. Therefore, to the extent there are variations of the invention, which are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is the intent that this patent will cover those variations as well. Finally, all publications and patent applications cited in this specification are herein incorporated by reference in their entirety as if each individual publication or patent application were specifically and individually put forth herein.
The instant application is an International Application based on U.S. provisional application No. 61/235,489, filed Aug. 20, 2009, the disclosure of which is hereby expressly incorporated by reference hereto in its entirety.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US2010/045915 | 8/18/2010 | WO | 00 | 3/29/2012 |
Number | Date | Country | |
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61235489 | Aug 2009 | US |