Abstract:
A laryngoscope-associated arrangement provides for focused delivery of a chemostimulant from a nebulizer through a delivery conduit to a patient&#39;s larynx to allow a practitioner to directly observe the function of the patient&#39;s larynx during the course of delivery of the chemostimulant. This not only provides the practitioner with a visualization of whether the patient&#39;s laryngeal vestibule is functioning properly, but allows the practitioner to be satisfied that the chemostimulant is accurately delivered to the intended region of interest.

Description:
CROSS-REFERENCE TO RELATED APPLICATION  
       [0001]    The present application is a continuation-in-part of co-pending U.S. patent application, Ser. No. 09/734,404 (hereinafter referred to as the &#39;404 application), filed Dec. 11, 2000, entitled: “Aspiration Screening Process for Assessing Need for Modified Barium Swallow Study,” by W. Robert Addington et al, which is a continuation of U.S. patent application, Ser. No. 09/224,431, filed Dec. 31, 1998, which is a continuation of U.S. patent application, Ser. No. 08/885,360, filed Jun., 30, 1997, now U.S. Pat. No. 5,904,656, which is a continuation of U.S. patent application, Ser. No. 08/559,562, filed Nov. 16, 1995, now U.S. Pat. No. 5,678,563, the disclosures of which are incorporated herein.  
         [0002]    In addition, the present application claims the benefit of co-pending U.S. Provisional Patent Application, Ser. No. 60/192,175, filed Mar. 27, 2000, by W. Robert Addington et al, entitled: “Laryngoscope Nebulizer for Application of Chemostimulant to Patient&#39;s Larynx to Stimulate Involuntary Cough Reflex,” and the disclosure of which is incorporated herein.  
     
    
     
       FIELD OF THE INVENTION  
         [0003]    The present invention relates in general to the field of speech pathology, and is directed to determining whether a patient is at risk for one or more abnormal physiological conditions, including but not limited to oral or pharyngeal dysphagia, and pneumonia. In particular, the present invention is directed to an enhancement to the invention disclosed in the above-referenced &#39;404 application, that provides focusing or ‘targeting’ delivery of the chemostimulant to stimulate nociceptor (irritant) and c-fibre receptors in the patient&#39;s throat, through a relatively narrow diameter tube that may be coupled with the observation tube of a laryngoscope. Coupling this nebulizer tube with that of the observation tube of a laryngoscope facilitates direct visualization of the mucosa of the laryngeal vestibule through a laryngoscope during inhalation and/or the laryngeal cough reflex, to determine whether the patient&#39;s larynx is functioning normally or abnormally.  
         BACKGROUND OF THE INVENTION  
         [0004]    As described in the above-referenced &#39;404 application, the conventional technique employed by speech pathologists for clinically identifying patients at risk for aspiration has involved the evaluation of a patient&#39;s swallow. A normal human swallow can be separated into four phases: 1) oral preparation, 2) the oral phase, 3) the pharyngeal phase, and 4) the esophageal phase. Patients who have suffered a stroke, traumatic brain injury or neuromuscular disorder (such as MS or ALS) have an increased risk of aspiration, and may have difficulty with either the oral phase, the pharyngeal phase or both, secondary to neurologic deficits.  
           [0005]    Poor tongue movement in chewing or in the swallow can cause food to fall into the pharynx and into the open airway before the completion of the oral phase. A delay in triggering the pharyngeal swallowing reflex can result in food falling into the airway during the delay when the airway is open. Reduced peristalsis in the pharynx, whether unilateral or bilateral, will cause residue in the pharynx after the swallow that can fall or be inhaled into the airway. Laryngeal or cricopharyngeal dysfunction can lead to aspiration because of decreased airway protection during the swallow.  
           [0006]    An abnormal human swallow is termed dysphagia. The oropharyngeal physiology involved in a normal swallow is very complicated, and many different neurological disturbances can disrupt normal swallowing and can cause aspiration of food material, liquid or solid, into the lungs, leading to increased morbidity in hospitalized patients and possible pneumonia. See, for example, the article by Jeri Logemann, entitled: “Swallowing Physiology and Pathophysiology,” Otolaryngologic Clinics of North America, Vol. 21, No. 4, Nov. 1988, and the article by L. Kaha et. al., entitled: “Medical Complications During Stroke Rehabilitation, Stroke Vol. 26, No. 6, Jun. 1995.  
           [0007]    Speech pathologists have tried many procedures to detect or predict aspiration in patients with neurological deficits. Although the standard bedside swallow exam to screen patients is beneficial for evaluating patients at risk for oral or pharyngeal dysphagia, studies have shown that, when compared to a modified barium swallow (MBS) videofluoroscopic examination, it is neither very specific nor sensitive in detecting aspiration. (The MBS test customarily involves having the patient ingest a volume of barium in a semi-solid or liquid form. Through fluoroscopy, the travel path of the swallowed barium may be observed by a medical practitioner to determine whether any quantity has been aspirated—which could lead to acute respiratory syndrome or pneumonia.) See, for example, the article by Mark Splaingard et. al. entitled: “Aspiration in Rehabilitation Patients: ideofluoroscopy vs. Bedside Clinical Assessment; Archives of Physical Medicine and Rehabilitation, Vol. 69, Aug., 1988, and the article by P. Linden, et. al., entitled” “The Probability of Correctly Predicting Subglottic Penetration from Clinical Observations”, Dysphagia, 8: pp 170-179, 1993.  
           [0008]    As discussed in the above-referenced Logemann article, and also in an article entitled: “Aspiration of High-Density Barium Contrast Medium Causing Acute Pulmonary Inflammation—Report of Two Fatal Cases in Elderly Women with Disordered Swallowing,” by C, Gray et al, Clinical Radiology, Vol. 40, 397-400, 1989, videofluoroscopic evaluations are more costly than bedside evaluations and videofluoroscopy is not entirely without risk. Because of the poor predictability of bedside exams, the MBS is being used more and more with its increased reliability for diagnosing aspiration. Many studies using videofluoroscopy have tried to pinpoint the exact anatomical or neurological deficit causing the dysphagia, as well as what stage of the swallow is primarily affected in different disorders.  
           [0009]    Patients with a head injury, stroke or other neuromuscular disorder can aspirate before, during, or after the swallow, and a high percentage can be silent aspirators. Unfortunately, these patients might not display any indication of aspiration during a clinical exam, but can be detected by the MBS, as discussed in the Logemann article and in an article by C. Lazurus et al, entitled: “Swallowing Disorder in Closed Head Trauma Patients,” Archives of Physical Medicine and Rehabilitation, Vol. 68, Feb., 1987, an article by J. Logemann, entitled: “Effects of Aging on the Swallowing Mechanism,” Otolaryngologic Clinics of North America, Vol. 23, No. 6, Dec. 1990, and an article by M. DeVito et. al., entitled: “Swallowing Disorders in Patients with Prolonged Orotracheal Intubation or Tracheostomy Tubes,” Critical Care Medicine, Vol. 18, No. 12, 1990.  
           [0010]    The bedside swallow exam that has been customarily performed by most speech pathologists evaluates history, respiratory status, level of responsiveness and an oral exam. The oral examination includes a detailed evaluation of the muscles of mastication, lips, tongue, palate, position in which the patient is tested, as well as swallowing evaluation. Sensation, various movements and strength are carefully evaluated. In the pharyngeal stage, the patient is tested for a dry swallow, thin liquid, thick liquid, pureed textures and solid textures.  
           [0011]    A typical bedside exam looks for nasal regurgitation, discomfort or obstruction in the throat or multiple swallows, as well as any visible signs that may indicate risk for aspiration, gurgling, impaired vocal quality, and coughing. The bedside exam results are then analyzed to determine whether the patient should have an MBS study to evaluate swallowing physiology and to rule out aspiration. Although the bedside exam is very thorough, and can identify patients who are at risk for or have dysphagia, it is not effective in determining which patients will aspirate.  
           [0012]    In addition to the foregoing, speech pathologists have historically had difficulty studying the sensory afferents of the larynx involved in airway protection. As described in an article by J. Widdicombe et al, entitled: “Upper Airway Reflex Control,” Annual New York Academy of Science, Vol. 533, 252-261, 1988, the sensory afferents for general coughing travel the internal branch of the superior laryngeal nerve. A patient may have a voluntary cough present with the efferent motor system intact, but not have any sensation on the larynx secondary to the afferents becoming completely or partially affected, which would be indicative of risk for silent aspiration.  
           [0013]    Although an MBS test is of value to patients that silently aspirate, it is difficult to decide which patients should have an MBS test. Not all patients with a closed head injury or a stroke will aspirate. Moreover, it is not economically realistic to employ an MBS test to evaluate all patients with neurologic deficits for aspiration. Advantageously, the chemostimulant-based, cough-invoking screening process described in the &#39;404 application and its parent predecessors, referenced above, successfully overcomes shortcomings of such conventional processes that have attempted to detect aspiration in patients with neurological deficits.  
           [0014]    Referring to FIG. 1, pursuant to the invention disclosed in these applications, a patient  10  (wearing a nose clip  12 ) is subjected to an chemostimulant-based, inhalation cough test. In this test, a prescribed quantity of a chemostimulant that stimulates nociceptor (irritant) and C-fibre receptors of the patient&#39;s larynx is injected into the patient&#39;s mouth. Inhalation of the chemostimulant may be readily accomplished by using a standard nebulizer  14 , that has been loaded with an aerosol chemostimulant, such as an atomized solution of tartrate mixed with saline. Not only has this solution has been demonstrated to stimulate a cough 100% of the time in normal individuals, but tartrate is considered safe, does not cause pain or discomfort, and has not been shown to cause bronchoconstriction or complications in asthmatics when inhaled in an aerosol form.  
           [0015]    The quantity of chemostimulant is injected into the patient&#39;s mouth for a prescribed period of time (e.g., on the order of 15 seconds) . The nebulizer output spray rate may be on the order of 0.2 ml/min. as a non-limiting example. The patient may be tested a prescribed number of times (e.g., up to three times) at different stimulant strengths until a cough is elicited. During each successive chemostimulant application, the patient receives progressively increasing concentrations of the aerosol for the prescribed period of time by tidal breathing at one minute intervals using successively increasing percentage concentrations (e.g. 20, 50 and 80 percent).  
           [0016]    Once a cough is elicited from the patient as a result of the inhaled aerosol stimulant, the patient&#39;s response to the inhalation test is graded. The patient may be graded as being at low risk for pneumonia (where the patient coughs immediately in response to the initial aerosol spray) or at a high risk for pneumonia (where a cough is present but decreased, or the patient does not readily cough in response to the initial concentration spray, but requires a more concentrated aerosol application).  
         SUMMARY OF THE INVENTION  
         [0017]    Now although the chemostimulant-based, cough-invoking screening process described in the &#39;404 application is effective to determine whether a patient is at risk for one or more abnormal physiological conditions, including but not limited to oral or pharyngeal dysphagia, and pneumonia, it may be desirable to provide the practitioner with the ability to focus delivery of the chemostimulant to a particular region of the throat and directly observe that region of the patient&#39;s airway during the course of delivery of the chemostimulant. This would not only provide the practitioner with a visualization of whether a particular region of the patient&#39;s throat (in particular, the laryngeal vestibule) is functioning properly, but it would allow the practitioner to be satisfied that the chemostimulant is accurately delivered to the intended region of interest.  
           [0018]    In accordance with the present invention, this objective is successfully accomplished by coupling the delivery port of the chemostimulant nebulizer with a throat insertable conduit. This conduit provides for focused delivery of the chemostimulant to that region of the patient&#39;s throat (the mucosa of the laryngeal vestibule) to be visualized by a monitoring device such as a laryngoscope. The chemostimulant conduit may comprise a relatively narrow flexible tube of the type used for airway-invasive procedures, so that the delivery port of the chemostimulant delivery tube may be inserted adjacent to the targeted and observed region of the throat.  
           [0019]    To this end, the chemostimulant-delivery tube may be physically coupled with the laryngoscope observation tube, so that both tubes may be simultaneously inserted into the patient&#39;s airway; alternatively, it may be fed separately of the laryngoscope tubing to the observation region. In either case, the invention provides for focused delivery of chemostimulant and direct visualization of the laryngeal vestibule through the laryngoscope during inhalation and/or the laryngeal cough reflex, to enable the practitioner to determine whether the patient&#39;s larynx is functioning normally or abnormally. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0020]    [0020]FIG. 1 diagrammatically illustrates the use of an aerosol inhaler in the chemostimulant-based, inhalation cough test disclosed in the &#39;404 application; and  
         [0021]    [0021]FIG. 2 diagrammatically illustrates the coupling of a throat insertable conduit at the output port of a chemostimulant nebulizer with the observation tubing of a laryngoscope to provide focused delivery of chemostimulant to a visualized region of patient&#39;s throat.  
     
    
     DETAILED DESCRIPTION  
       [0022]    As pointed out above, the present invention provides an enhancement to use of a chemostimulant to stimulate nociceptor (irritant) and c-fibre receptors in the patient&#39;s throat as described in the above-referenced &#39;404 application, by coupling the delivery port of the chemostimulant nebulizer with a throat insertable conduit. This serves to achieve focused delivery of the chemostimulant to that region of the patient&#39;s throat (the mucosa of the laryngeal vestibule) being visualized by a device such as a laryngoscope, and allows a medical practitioner to visually monitor the functioning of the patient&#39;s airway in the course of determining whether the patient is at risk to one or more abnormal physiological conditions, such as oral or pharyngeal dysphagia, and pneumonia.  
         [0023]    In accordance with a non-limiting embodiment the laryngoscope-associated, focused chemostimulant delivery process of the invention, diagrammatically illustrated in FIG. 2, the patient  10  may wear a nose clip  12 , as in the inhalation cough test of FIG. 1, described above. The nebulizer, shown at  20 , may comprise a standard pneumatically controlled atomizer device, that is supplied with an aerosol chemostimulant, such as a solution of twenty percent concentration by volume of tartrate mixed with saline, described in the &#39;533 Patent. As pointed out above, this solution has been demonstrated to stimulate a cough one-hundred percent of the time in normal individuals; also tartrate is considered safe, does not cause pain or discomfort, and has not been shown to cause bronchoconstriction or complications in asthmatics when inhaled in an aerosol form.  
         [0024]    To control its operation, the nebulizer  20  is coupled via a pneumatic control input line  22  to a pulse atomizing pneumatic source (not shown). In accordance with the invention, nebulizer  20  has its output port  23  fitted with a length of relatively narrow chemostimulant delivery conduit  25 . The conduit  25  may comprise a section of flexible tubing of the type used for airway-invasive procedures, so that it may be readily fed through the patient&#39;s airway, such as the patient&#39;s nasal cavity  31 , with a distal end  27  of the conduit  25  placed adjacent to a targeted and visually observable region of the patient&#39;s throat  33 .  
         [0025]    To facilitate its use with a laryngoscope, shown at  40 , the chemostimulant-delivery tube  25  may be physically coupled with an associated length of the laryngoscope&#39;s observation tube  42 , as by means of a flexible adhesive or other attachment medium, so that both tubes may be simultaneously inserted into the patient&#39;s airway and fed to a desired observation, chemostimulation region (shown as being in proximity of the patient&#39;s vocal cords  51  and laryngeal vestibule  53 ). Alternatively, the chemostimulant-delivery tube  25  may be fed separately of the laryngoscope tubing  42  to the region of interest.  
         [0026]    In either case, the chemostimulant delivery tube  25  is fed into the patient&#39;s airway such that the distal end  27  of the tube is positioned adjacent to the distal end  44  of the laryngoscope&#39;s tube  42 . This ensures that delivery of the chemostimulant to the target region of the patient&#39;s throat, such the laryngeal vestibule  53 , may be directly observed through the laryngoscope  40  during inhalation and/or the laryngeal cough reflex, and enable the practitioner to determine whether the patient&#39;s larynx is functioning normally or abnormally.  
         [0027]    Similar to the inhalation test performed in accordance with the methodology described in the &#39;533 Patent, controlled pulsing of the nebulizer  20  causes a prescribed quantity of atomized chemostimulant to be injected (through the delivery conduit  25 ) into the patient&#39;s airway. However, unlike the mouth-based injection scheme of the &#39;533 Patent, the use of the conduit  25  at the output of the nebulizer  20  provides for ‘focused’ delivery of the chemostimulant directly to the region of the patient&#39;s throat to be stimulated. Being coupled with and terminated at the distal end  44  of the laryngoscope observation tubing  42  enables the chemostimulant delivery conduit  25  to target the atomized spray within a confined region being visualized through the laryngoscope  40 , and thereby allows the medical practitioner to visually monitor the functioning of the patient&#39;s airway (e.g., laryngeal vestibule).  
         [0028]    Again, the patient may be tested a prescribed number of times at different stimulant strengths until a cough is elicited. During successive chemostimulant injections, the patient may receive progressively increasing concentrations of the chemostimulant within the aerosol mixture, using successively increasing percentage concentrations (e.g. 20, 50 and 80 percent) of chemostimulant. Once a cough is elicited from the patient as a result of the inhaled aerosol mixture, the patient&#39;s response to the inhalation test may be graded, as in the patient evaluation process detailed in the &#39;533 Patent.  
         [0029]    As will be appreciated from the foregoing description, coupling the delivery port to a chemostimulant nebulizer with a throat insertable conduit not only enables focused delivery of the chemostimulant to a targeted region of the patient&#39;s throat (e.g., the mucosa of the laryngeal vestibule) but, when coupled with the observation tubing of a monitoring device such as a laryngoscope, allows a medical practitioner to visually monitor the functioning of the patient&#39;s airway during chemostimulant injection.  
         [0030]    While we have shown and described an embodiment in accordance with the present invention, it is to be understood that the same is not limited thereto but is susceptible to numerous changes and modifications as known to a person skilled in the art. We therefore do not wish to be limited to the details shown and described herein, but intend to cover all such changes and modifications as are obvious to one of ordinary skill in the art.