Patent Application
20100089404
The present disclosure is directed to medical devices. More particularly, the present disclosure is directed to endotracheal and tracheostomy devices.
Normal ventilation results from the contraction and expansion of the diaphragm, leading to the cyclic flow of oxygen into, and carbon dioxide out of the lungs. Mechanical ventilation may be indicated for critical care and surgical patients unable to ventilate on their own. Mechanical ventilation is generally provided with an endotracheal tube fluidly coupled to a mechanical ventilator. Morbidity and mortality resulting from both mechanical ventilation and the underlying condition can be significant. A major contributor to the morbidity and mortality is ventilator-assisted pneumonia (“VAP”). Colonization of the lower respiratory tract, especially with gram negative bacteria, may be an early stage in the development of VAP. Aspiration of colonized secretions is a leading cause of VAP.
During use of conventional endotracheal tubes, mucus often accumulates on the surface of the tubes. The mucus originates at the tracheal tissue, which is coated with layers of mucus secretions that play a major role in host defense. Intubated patients cannot clear their airways by expectoration, and some may suffer from mucus hypersecretion. To ensure proper ventilation, the airway must be cleared of excess mucus. Such removal may be effectuated mechanically, for example, by shaving, and frequent suctioning may be required. Mucus shaving and/or suctioning may be uncomfortable and/or painful to patients. In addition, clearance of airway secretions using suction catheters and other devices via the endotracheal tube can substantially increase the risk of nosocomial infections, especially VAP. Accordingly, it may be desirable to remove mucus from endotracheal tubes without mechanical intervention and in a more comfortable manner.
Conventional endotracheal tubes may be either flexible or relatively stiff. Some adult tubes have an inflatable member to seal the lower airways against air leakage and aspiration of secretions, while smaller pediatric tubes generally are unmembered.
With some conventional endotracheal tubes, attempts have been made improve suctioning efficiency by modifying suctioning orifice geometry, by modifying member design to create a collection basin, and by interchanging suction devices. It may be desirable to provide an endotracheal tube that simply and inexpensively directs fluids to the suctioned region.
A tracheotomy is a relatively common procedure for bypassing a tracheal obstruction. A tracheostomy tube is inserted into the trachea by making an incision in neck tissue. The tracheostomy tube provides access to the trachea below the larynx in the neck of a patient. The primary objective in using a tracheostomy tube is to provide adequate airway ventilation. The tube can permit passive ventilation, i.e., ventilation occurring without assistance. Alternatively, the tracheostomy tube can provide access for mechanically assisted ventilation for patients that are unable to breathe on their own. It is not unusual for the tracheostomy stoma to bleed after surgery. According to various embodiments, it may be desirable to provide a tracheostomy tube that enhances clotting.
According to various aspects of the disclosure, an endotracheal device may include an elongated body member having a first end and a second end, first and second lumens defined by the body member, and a funnel member proximal the second end. The first lumen may extend from a first opening in the first end to a first opening in the second end. The second lumen may extend from a second opening in the first end to at least one port in a wall of the body member proximal the second end. The funneling member may be configured to direct fluid toward at least one of the ports in the wall.
In some aspects of the disclosure, an endotracheal device may comprise an elongated body member defining at least one lumen. At least a portion of the elongated member may be configured to release a mucolytic agent.
In accordance with various aspects of the disclosure, a tracheostomy device may comprise an elongated body member defining a lumen, with the body member comprising a clotting agent.
An exemplary embodiment of an endotracheal device 100 is illustrated in
The elongated body member 102 may define a first lumen 112 extending from a first opening 114 in the first end 104 to a first opening 116 in the second end 106. The body member 102 may define a second lumen 122 extending from a second opening 124 in the first end 104 to at least one port 126 in a wall 108 of the body member 102 proximal the second end 106.
According to certain embodiments, the endotracheal device 100 may include a funneling member 130 proximal the second end 106 of the elongated body member 102. According to various aspects, the funneling member 130 may comprise a disc-shaped member. As shown in
According to various aspects, the funneling member 130, 330 may comprise a thin material constructed from, for example, silicone. The funneling member 130, 330 may be configured to cooperate with an inner wall 192 of a patient's trachea 190 to substantially form a tracheal seal to prevent aspiration of secretions.
According to various aspects, the endotracheal device 100, 300 may include a suction device 140 fluidly coupled to the second opening 124 in the first end 104 of the body member 102. The suction device 140 may be configured to aspirate fluids from a region 145 external the body member 102 proximal the part(s) 126 in the wall 108.
In some aspects, the endotracheal device 100, 300 may comprise an inflatable member 150 about the body member 102 proximal the second end 106. The elongated body member 102 may define a third lumen 152 (
Once the endotracheal device 100, 200 is positioned in a patient's trachea 190, the air source may be operated to inflate the inflatable member 150 so that the inflatable member 150 may cooperate with the tracheal wall 192 to seal the lower airways (not shown) against air leakage and aspiration of secretions. The inflatable member 150 may be nearer the second end 106 relative to the port(s) 126 in the wall 108, such that secretions are maintained above the inflatable member 150 (when inflated) to facilitate suctioning thereof.
In accordance with various aspects, at least a portion of the endotracheal device 100, 300 may be configured to release at least one mucolytic agent. For example, in some aspects, a portion of the endotracheal device 100, 300 may be impregnated with the mucolytic agent(s). According to various aspects, the impregnated portion may include the funneling member 130, 330. In some aspects, a portion of the endotracheal device 100, 300 may comprise a coating containing the mucolytic agent(s). According to various aspects, the coated portion may include the funneling member 130, 330.
The mucolytic agent(s) may be chosen from, for example, acetyl cysteine, guaifenesin, and sodium thioglycolate. The mucolytic agent may prevent mucus from accumulating on the body member 102 as it is being removed and re-inserted. Some mucolytic agents such as, for example, acetyl cysteine, dissolve mucus. Some mucolytic agents such as, for example, guaifenesin, may function as expectorants.
Referring now to
Sodium thioglycolate possesses free sulfhydryl groups that are expected to dissolve mucus by breaking disulfide bonds between gel-forming mucins. A 0.01-0.5% solution, for example, a 0.1% solution, of sodium thioglycolate in saline can dissolve human mucus.
According to some aspects, at least a portion of the endotracheal device 100, 300, 400 may be coated and/or impregnated with an antimicrobial agent. The antimicrobial agent may comprise, for example, a composition including silver. Some examples of antimicrobial agents consistent with this disclosure are described in U.S. Pat. No. 6,949,598, the disclosure of which is incorporated herein by reference in its entirety.
Referring now to
According to another embodiment of the present disclosure, at least a portion of a drain tube, such as a chest drain, is coated and/or impregnated with a proteolytic agent. Suitable non-limiting examples of proteolytic agents include acetyl cysteine, guafenesin, and sodium thioglycolate. Examples of suitable drain tubes include those described in PCT/US07/60156, filed Jan. 5, 2007, the disclosure of which is incorporated herein by reference in its entirety.
Endotracheal tubes extubated from human patients were covered in a think layer of mucus Some tubes were washed in a 0.1% solution of sodium thioglycolate in saline, while a control group of tubes were washed in saline. The mucus was immediately dissolved from the tubes that were washed in thioglycolate, while the mucus layer remained intact in the saline control group tubes.
It will be apparent to those skilled in the art that various modifications and variations can be made in the medical devices and methods of the present invention without departing from the scope of the invention. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only.
This application claims benefit of priority to U.S. Provisional Patent Application No. 60/886,574, filed Jan. 25, 2007, entitled “Endotracheal and Tracheostomy Devices.”
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/US08/51891 | 1/24/2008 | WO | 00 | 12/7/2009 |
| Number | Date | Country | |
|---|---|---|---|
| 60886574 | Jan 2007 | US |
