The present invention relates to devices adapted to facilitate respiration of an awake or unconscious medical patient.
Tooling has been developed to facilitate insertion of one or more tube into a medical patient during an intubation procedure. Known tooling operable to facilitate intubation includes introducers and temporary airways. An introducer has a distally curved blade and a manipulating handle that is proximally protruding from its intersection with the blade. The entire introducer is transversely very stiff to permit its use as a path-clearing tool. A medical practitioner grasps the handle and inserts the blade into the mouth of a patient to manipulate soft tissue effective to clear a passageway to facilitate installing an intubation tube into a medical patient. The blade serves as a guide for the subsequently inserted tube. Due to its permanently affixed and proximally protruding handle, an introducer cannot be left unattended in the mouth of the patient. An inadvertent blow on the handle could cause damage to internal portions of the patient.
In contrast to an introducer, a fully installed temporary airway disposes no significant amount of substantially rigid structure protruding from the mouth of a medical patient. A temporary airway may be installed in the mouth and pharynx of an awake or unconscious medical patient. In one exemplary use, a temporary airway may be installed in a patient that has experienced mandibular, oral cavity, or pharyngeal trauma. The temporary airway functions as a breathing path by providing a conduit for air to flow past damaged or otherwise potentially blocking tissue, and may be left in place and unattended. Desirably, the temporary airway also provides guide structure to facilitate intubation of the patient.
One temporary airway known as a Williams Airway Intubator is commercially available from Anesthesia Associates, Inc. having a place of business located in San Marko, Calif. The Williams Airway Intubator carries markings indicating that it is manufactured in Canada. Such a temporary airway is structured to provide a closed-tube proximal portion, and an open-tube distal portion. The open-tube portion essentially provides a curved spatula that is shaped to approximate structure upstream of the patient's tracheal entrance. The spatula also provides a guide surface effective to orient a tube during an intubation procedure. Because the closed-tube portion is a circumferentially unbroken conduit, the temporary airway must be removed from the patient by sliding the airway proximally along any installed intubation tubing. Such a removal procedure undesirably requires disassembly of breath-supplying tubing to permit removal of the temporary airway from encircling engagement around that tubing.
Another temporary airway is known as the Berman Intubating Pharyngeal Airway. A commercially available version is packaged by Vitalsigns, Inc., which company has the web site address www.vital-signs.com. The packaging of one recently obtained embodiment carries U.S. Pat. Nos. 4,054,135; 4,067,331; 4,068,658; and 4,069,820, the disclosures of which are all hereby incorporated in their entirety by this reference. As disclosed in the aforementioned patents, the Berman Intubating Pharyngeal Airway may be structured in various ways to permit its removal from an intubated patient without requiring disassembly of the breath-supplying intubation tubing.
Temporary airways have been in use for a long period of time, as evidenced by U.S. Pat. No. 2,599,521 titled “Respiratory device”, which issued Jun. 3, 1952, to R. A. Berman. Improvements have been made on an on-going basis, as evidenced by the other previously mentioned United States patents. However, long-felt needs remain that still have not been addressed by known devices. For one example, insertion of a temporary airway into an awake patient typically requires application of an anesthetic agent to overcome the patient's automatic gag reflex. Such anesthetic application currently requires assembly of tools such as swabs, or other fluid-application devices, which complicates the procedure, and may clutter the care environment. For another example, potentially life-saving gas, such as pure Oxygen, may be administered to a patient through presently available temporary airways only subsequent to at least substantial completion of an intubation procedure. That is, application of Oxygen must wait for installation of the airway, and subsequent intubation to supply the gas. It would be an advance in the state-of-the-art to provide a temporary airway that solves one or more of such long-felt needs, or otherwise provides an improved temporary airway.
The invention may be embodied as a temporary airway that can also be used to facilitate an intubation procedure. An exemplary temporary airway includes a body extending from a proximal end to a distal end. The body is shaped in general accordance with structure of a human mouth and pharynx, and may be formed in a plurality of sizes to accommodate small children through large adults. A wall of the body substantially encloses an intubation lumen that can be used to assist in guiding intubation tubing into an installed position in a medical patient. The body is desirably sufficiently resistant to collapse such that the patient's tongue, or other tissue, cannot obstruct the intubation lumen. Therefore, the empty intubation lumen may serve as a temporary airway conduit through which the patient may breath.
Desirably, the body's wall is configured to permit extraction of the airway from the mouth of an intubated patient without requiring disassembly of any installed intubation apparatus. One workable arrangement provides a body with a slot, or other opening arrangement, that permits passage of installed intubation tubing in a transverse direction through the wall. Sometimes, the slot may be configured to enlarge effective to permit transverse passage of intubation tubing. For example, a flexible wall may be bent out-of-the-way to permit removing a temporary airway from substantially encircling engagement around an intubation tube.
At least one treatment lumen is desirably associated with the body. A treatment lumen may be used to dispense a variety of treatment substances, nonexclusively including anesthetic agent and Oxygen. In certain cases, a pigtail, or length of tubing, may be associated with a treatment lumen or channel and arranged to protrude proximally from the temporary airway. Such a tubing desirably includes one or more connector capable of placing a treatment substance into fluid communication with the tubing. Certain connectors may place a plurality of treatment substances into fluid communication with the same length of tubing. A plurality of conduits may be associated with a body of an airway, if desired.
In some currently preferred embodiments, the body carries a treatment channel, in which one or more treatment conduit may be trapped to resist transverse displacement of the conduit(s) from within the channel. Because the body may be formed from a material that resists adherence of adhesive, axial motion of a treatment conduit relative to the body is sometimes resisted by one or more stopper. An operable stopper may be formed from an adhesive that adheres to a treatment conduit and then forms a structural interference with a portion of the treatment channel. One currently preferred embodiment of a temporary airway has a treatment channel configured to capture a pair of treatment conduits. The same principles of operation encompass one or more multi-lumen treatment conduit.
It is currently preferred to provide a temporary airway with a treatment lumen capable of dispensing anesthetic agent during installation of the airway into the mouth of a medical patient. Desirably, the treatment lumen expels anesthetic agent through a dispersion nozzle effective to spread anesthetic agent approximately evenly over an area. A currently preferred such nozzle is an atomizing nozzle. The most preferred atomizing nozzle is affixed to a treatment conduit with a coupling that forms a lap joint with both the conduit and a length along an outside diameter of the body of the atomizer.
Typically, a mouth guard is affixed at the proximal end of the body, and is configured to resist over-insertion of the body into the mouth and pharynx of the patient. Sometimes, a removable proximally-protruding handle may be provided to assist in installing a temporary airway.
In the drawings, which illustrate what are currently regarded as the best modes for carrying out the invention, and in which similar structures in different views are designated with like numerals:
The present invention may be structured to provide a temporary airway for a medical patient. A first exemplary embodiment structured according to certain principles of the instant invention is indicated generally at 100 in
For purposes of this disclosure, a temporary airway differs from an introducer. In contrast to an introducer, an installed temporary airway that is structured according to certain principles of the instant invention has a limited amount of structure protruding from a patient's mouth. Certain embodiments of a temporary airway 100 may be configured to dispose no structure protruding proximally from the mouth flange 104. Other embodiments of a temporary airway may include permanently attached structure configured to protrude proximally from the mouth flange, such as one or more length of tubing 108, which is transversely compliant, and therefore cannot be used as a lever to move the internally-disposed structure of an installed temporary airway effective to manipulate, or potentially damage, soft tissue.
With reference to
With reference to
The illustrated temporary airway 100 includes a mouth flange 104 disposed at its proximal end. The distal side of the mouth flange 104 provides a contact surface 144 that typically rests in contact with a patient's lips upon installation of the temporary airway 100. The mouth flange 104 is desirably configured and arranged to resist over-insertion of the body 120 of the airway 100 into the patient's oral cavity. Typically, the mouth flange 104 operates as a portion of a handle that a health practitioner may grip to manipulate the airway 100 during its installation into a medical patient. A finger may also be placed into entrance aperture and used as a lever during installation of an airway.
A bite guard, generally 148, is desirably disposed in distal proximity to the mouth flange 104, and is typically structured to resist imparting damage to a medical instrument (which may be installed in the intubation, or airway, lumen 112), from a patient's teeth due to an inadvertent bite-down. A wall portion 152 having sufficient thickness to resist significant deflection and/or damage from the patient's teeth may form an operable bite guard 148. As illustrated, the wall portion 152 may be reinforced, or built-up, in a local area. In other embodiments, an operable bite guard 148 may be formed from a wall of body 120 that is substantially uniform in thickness.
The external surface of the body 120 of a temporary airway is desirably smooth and slippery to assist in its installation and removal from the patient's oral cavity. Similarly, the guide surface internal to the airway lumen 112 is desirably smooth and slippery to assist in sliding the leading edge of a tube or instrument through that lumen. It is also desirable to provide an airway 100 with blunt corners and smooth edges, generally indicated at 150 in
Body 120 may sometimes be injection molded from urethane. However, it is currently preferred to injection-mold a body from polypropylene or polyethylene, due to their ability to provide an inherently slippery surface. Operable materials of construction of the body of a temporary airway include: medical grade plastics and plastic-like materials, such as polypropylene, polycarbonate, PVC, silicone, rubber, urethane, and the like.
Illustrated body 120 of temporary airway 100 is structured as a two-part housing that is injection molded as a two-sided clamshell. Subsequent to molding, the two sides of the clamshell are joined together, forming parting line 156. A suitable connection between respective components may be formed by an adhesive, welding, or using other manufacturing techniques that are known in the art. Certain bodies 120 may alternatively include a hinged portion to permit forming the halves in the same mold, then rotating the halves approximately 90 degrees during assembly of the body.
In general, the external axially-curved convex area, generally 160, of body 120 is structured to cooperate with the shape of a patient's palette, and desirably is contiguous for at least 180 degrees around a rear circumference (that is, fully enclosed on at least the internal axially-curved concave surface), to provide a robust guide surface for an inserted tube, conduit structure, or other medical instrument, to follow. The external axially-curved concave area 142 is generally shaped in agreement with a patient's oral cavity to dispose the lumen's tube guide exit aperture 128 at the base of the patient's tongue and in an aiming orientation with respect to deeper tracheal structure.
The illustrated embodiment 100 includes an intubation lumen 112 extending through the body 120 and having an open slot 132 extending along a front wall. That is, lumen 112 includes an axially-extending front opening 132 and a substantially uninterrupted rear side. The rear side is structured to guide a conduit (e.g. intubation tubing), or medical instrument, through the oral cavity of the patient for tracheal installation of the conduit or instrument. The illustrated open slot 132 is structured to permit removal of the temporary airway 100 from the mouth of an intubated patient without requiring removal of fittings, coupling devices, or removing upstream conduit structure from fluid communication with intubation tubing prior to release of that intubation tubing from engagement within the temporary airway's lumen 112. The installed tubing may simply be passed transversely through a portion of the housing's axially extending front wall.
In one use, an intubation tube may be inserted into the proximal opening 126 of an installed temporary airway 100. The installed intubation tubing may be placed into fluid communication with a breathing apparatus to assist the patient to breath. Then, the temporary airway 100 may be removed from the patient's mouth without interrupting breathing treatment of the patient. The body 120 of the temporary airway 100, which is disposed circumferentially around the intubation tubing, may simply be stripped from engagement with the intubation tubing: either during removal of the airway 100 from seated engagement inside the patient's mouth, or subsequent to such removal.
As illustrated in
Certain embodiments may optionally include one or more treatment lumen, generally 162, through which oxygen, one or more other gasses, and/or one or more treatment fluids or substances 164, may be administered. A treatment lumen 162 differs from an intubation lumen by forming a path for treatment fluids that is at least partially distinguished from the path for a breathing tube used in an intubation procedure. Sometimes, an anesthetic agent may be administered as a treatment fluid, e.g. to facilitate insertion of the temporary airway into the oral cavity of an awake patient. Also, a treatment substance 164, such as oxygen, may be dispensed during the intubation process as a bridge to prolong a time-window during which intubation may occur without causing patient mortality. It has been determined that directing a stream of Oxygen into the tracheal area of a patient may cause sufficient gas exchange in the patient's lungs as to enhance the patient's oxygen uptake without requiring the patient to inhale, or exhale.
The embodiment illustrated in
As illustrated, a conduit pigtail section 108 may be connected to a coupler 176 effective to place a plurality of implements, or gas/fluid sources, into fluid communication with the conduit pigtail. An operable coupler 176 includes any structure that may place one or more devices, or fluid/gas source, into fluid communication with the pigtail conduit 108. A workable coupler includes a y-connector commercially available, under part number 80386, from Qosina, having a place of business located at 150-Q Executive Drive, Edgewood, N.Y. 11717-8329, and a web site at www.qosina.com/.
The illustrated coupler 176 includes a pair of luer-lock threaded portions 172 disposed in Y-formation to receive fluid communicating devices for individual or joint fluid communication with the pigtail portion of conduit. A treatment substance 164, such as oxygen, or air, may be administered by coupling the appropriate gas source to the coupler 176. Anesthetic agent can be applied by connecting an operable supply source, such as a syringe 180, to the coupler 176.
Placing the pigtail conduit 108 (and thereby the treatment lumen 162) into fluid communication with a plurality of treatment devices permits a health practitioner to perform overlapping treatments. For example, oxygen gas may be coupled with one port of the coupler 176, and a syringe 180 loaded with anesthetic agent may be coupled with a second port of the coupler 176. In such case, a stream of Oxygen gas may be applied, and anesthetic agent may be suitably dispersed downstream from the treatment lumen discharge port under influence of the gas stream.
As perhaps best illustrated in
Alternative structures forming a treatment lumen 162 are within contemplation. One alternative treatment lumen 162 may be formed from a length of treatment conduit that is associated with the body 120 and configured to provide a fluid-communicating lumen extending from the proximal portion of the airway 100 and partially to, or substantially to, the distal end of the airway. Desirably, the treatment conduit would have a small diameter in comparison to the diameter of the airway or intubation lumen 112. One way to associate such a treatment conduit with an airway 100 is to simply adhere the conduit to the external surface of the body 120. A channel, or groove, may also be formed in a portion of the body, to assist in routing the treatment conduit.
In certain cases, a treatment fluid may be sufficiently dispersed simply by action of the administered gas(ses) passing across a pressure drop formed across a discharge orifice of a treatment lumen. Certain embodiments within contemplation may also include a dispersion nozzle effective to discharge fluids in a misted form from the treatment lumen's discharge orifice. It has been determined that Oxygen, air, or one or more other gasses, may be adequately administered through such an orifice effective to extend a patient's survival time prior to completion of an intubation procedure.
A second, and currently preferred, embodiment of a temporary airway structured according to certain principles of the instant invention is illustrated in
Still with reference to
As illustrated, temporary airway 200 includes a plurality of treatment lumens provided by treatment conduits, including conduit 216 and conduit 220. Conduit 216 is adapted to permit application of anesthetic agent during installation of the airway 200 into a medical patient. Conduit 220 is adapted to permit application of one or more treatment gas during installation of the airway 200 into a medical patient. A connector, such as luer-lock fitting 224 or hose barb 228, may be provided on a proximal end of a conduit to assist in connection to a source of fluid, such as an anesthetic agent or a gas such as Oxygen or compressed air. While it is currently preferred for the exposed axial length of a conduit to be relatively small (e.g. from less than about 1 inch to about 3 inches, or more), a conduit pigtail may have any desired length. Furthermore, any number of conduits may be provided in alternative embodiments.
Conduit 216 extends distally from a proximal end of body 204 toward a dispersion nozzle, generally 232. It is generally desirable for the dispersion nozzle 232 to be positioned at, or near, the distal end of the airway 200 to facilitate fluid dispersion. Conduit 220 extends from a proximal end of body 204 toward the distal end of body 204. Sometimes, conduit 220 may terminate at an intermediate location along a length of a body. While many ways will be apparent to one of ordinary skill-in-the-art, it is currently preferred to associate at least one treatment conduit with a body by engagement of the conduit within a channel, such as channel 236 (e.g. see
It is desirable for a conduit, such conduits 216 or 220, to be formed having a relatively small outside diameter to avoid obstructing an intubation path, or requiring a large diameter in a cross-section of body 204. Illustrated conduits 216, 220 may be extruded from medical-grade plastic, and are commercially available. In a currently most preferred embodiment, each of conduits 216, 220 has an outside diameter of about 0.060 inches. It is sometimes further desirable for conduit 220 to function as an automatic regulating device to limit a flow of Oxygen to less than about 10 liters/min from a supply source at a pressure of about 50 psi. Therefore, an inside diameter of one preferred conduit 220 may be about 0.020 inches.
It is currently preferred to injection mold body 204 as a one-piece component from polyethylene or polypropylene. Such materials are capable of providing surfaces that are inherently “slippery”. However, adhesives generally do not bond well to such materials. Therefore, channel 236 is structured directly to resist removal there-from of at least one conduit in a transverse direction. In the illustrated embodiment 200, channel 236 is sized to form a slip-fit cooperating with conduits 216 and 220 to permit sliding those conduits into an installed position. Stopper structure, such as distal stopper 240 (see
Workable stopper structure, such as stopper 240 and stopper 244, forms a structural inference with a portion of the channel 236 to resist axial displacement of a conduit. Stopper 240 and stopper 244 can be formed by a small portion of adhesive that is applied subsequent to inserting the conduits 216 and 220 into a desired position inside channel 236. One workable adhesive is a UV-cured adhesive conventionally used in the assembly of medical products. The cured adhesive adheres well to the material forming the conduits 216 and 220. As illustrated in
Details of an exemplary dispersion nozzle 232 are illustrated in
Ejection orifice 248 is disposed at a distal end of nozzle body 252. It has been found that a workable diameter for an operable ejection orifice is about 0.008 to 0.010 inches, or so. In the illustrated embodiment 232, the diameter of an exemplary nozzle body 252 is about 0.060 inches, in harmony with the outside diameter of an exemplary and cooperating conduit 216. The exemplary nozzle body 252 may be formed by injection molding from a medical-grade plastic, such as polycarbonate, or from an alternative plastic, or plastic-like material.
Coupling 256 has a through-bore 260 with an inside diameter sized to form a slip fit with both of body 252 and conduit 216. A workable coupling 256 may be formed from relatively thin-walled tubing. One workable tubing that may be used to form a coupling 256 includes extruded polyimide tubing having a nominal outside diameter of about 0.069 inches, and a nominal inside diameter of about 0.0615 inches. A lap joint may be formed by adhesive disposed between the coupling 256 and each of nozzle body 252 and the distal end of conduit 216. Again, a workable adhesive is a UV-cured adhesive conventionally used in the assembly of medical products. Treatment fluid delivered through fluid delivery lumen 264 is therefore confined to flow distally through ejection orifice 248. Note that the body 252, conduit 216, and coupling 256 are not required to be round, although such construction is more simple.
With particular reference now to
As illustrated in
As previously mentioned, a mouth flange 104 typically operates as a portion of a handle that a health practitioner may grip to manipulate the airway 100 during its installation into a medical patient. The health practitioner may sometimes insert a gloved finger into a proximal portion of the lumen 112 to assist in manipulation of the body 120 during installation of the device into a medical patient. As one alternative, a removable handle portion, generally 300 in
While the invention has been described in particular with reference to certain illustrated embodiments, such is not intended to limit the scope of the invention. The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.
This application claims the benefit of the filing date of U.S. Provisional Patent Application Ser. No. 61/097,845, filed Sep. 17, 2008, for “TEMPORARY AIRWAY”, the entire contents of which are hereby incorporated by this reference.
Number | Date | Country | |
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61097845 | Sep 2008 | US |