WO2010039774A1 - Systems and methods of treating apnea - Google Patents

Abstract

A system and method useful for treating apnea in a patient, include an exo-tracheal flange surgically implanted on the patient's trachea. A tracheostomy is performed to place a bore extending through the flange in air communication with the trachea. An optional exotracheal cuff at least partially surrounds the trachea, and the flange is attached to the cuff. A skin port is implanted at an opening formed in the patient's skin, preferably at the patient's neck, but optionally at a remote location such as behind the patient's ear. One or more tubes connect the exo-tracheal flange to the skin port to form a supplemental air passageway, which provides an additional pathway for air to be inhaled by the patient.

Description

SYSTEMS AND METHODS OF TREATING APNEA

[0001] This application claims priority under the Paris Convention and 35 U. S. C. §§ 119, 365 to U.S. provisional patent application no. 61/101,327, filed 30 September 2008, the entirety of which is incorporated by reference herein.

BACKGROUND

Field of Endeavor

[0002] The present invention relates to devices, systems, and processes useful for the treatment of apnea.

Brief Description of the Related Art

[0003] Breathing and Sleep

[0004] I. Breathing Background

[0005] Breathing consists of taking air into the lungs, or inhalation, and expelling air from the lungs, or expiration. Normally, inspiration is an active process requiring various muscles to contract while expiration is passive, a recoil from energy previously stored in muscles, ligaments, and tendons during inspiration.

[0006] Breathing is orchestrated by the brain which integrates emotional, chemical, and physical stimuli to regulate air movement into and out of the lungs. Regulation is controlled through the activation of motor nerves originating in the brain (cranial nerves or CN) and from nerves whose bodies are in the spinal cord. When recruited, these nerves cause various muscles to contract or to remain relaxed. In humans, quiet breathing occurs primarily through the cyclical stimulation of the muscles of the two hemi-diaphragms.

[0007] Breathing is under conscious and unconscious control. With an intact brain, an individual can take or not take a breath when ever desired. Singers and wind instrument musicians control breathing consciously to make music; swimmers gulp in a full lung of air in a second. Voluntary control of breathing originates in the cerebral cortex, although, in the extreme, various chemo-receptor reflexes are capable of overriding conscious control. [0008] However, most of the time breathing is unconsciously controlled by specialized centers in the brainstem, which automatically regulate the rate and depth of breathing to match the body's needs at any given time. In addition to involuntary control of breathing by these respiratory brain centers, breathing is unconsciously influenced by a person's emotional state, by way of inputs from the limbic system, and by ambient temperature, by way of the hypothalamus. [0009] Breathing rate and depth of breathing is tightly controlled by the brain. Changes in rate and depth of breathing are determined primarily by blood levels of carbon dioxide and secondarily by low or very low blood concentrations of oxygen. Chemo-receptors associated with three arteries, the carotid bodies at both carotid bifurcations and in the aortic arch, respond to changes in the blood concentration oxygen and carbon dioxide. Afferent neurons from the carotid bodies and aortic bodies reach the brain by way of the glossopharyngeal nerve (CN IX) and the vagus nerve (CN X), respectively.

[0010] Levels of CO₂ rise in the blood when the metabolic consumption of O₂ is increased beyond the capacity of the lungs to expel CO₂. CO₂ is stored in the blood primarily as bicarbonate (HCO₃-) ions, first by conversion to carbonic acid (H₂COs) through the enzyme carbonic anhydrase, and then by disassociation of this acid into H+ and HCO₃-. Build-up of CO₂ therefore causes an equivalent increase in hydrogen ion concentration. By definition, an increase in blood hydrogen ion concentration is a decrease in blood pH. A drop in blood pH stimulates the chemo-receptors in the medulla oblongata and the pons, in the brain.

[0011] When the brain senses that carbon dioxide concentration is high, that pH is low, and that oxygen concentration is low, it sends nerve impulses through the phrenic and thoracic nerves, respectively, to the muscles of the diaphragms and the intercostal muscles, through the hypoglossal nerve (CN XII) to the muscles of the tongue, and through the recurrent laryngeal nerve (a branch of CN X) to the muscles of the larynx. These and other nerve impulses cause the hemi-diaphragm muscle to contract, inhibits contraction of the intercostal muscles, and cause the complex muscles in the pharynx to contract. Contraction of the hemi-diaphragm muscles cause the volume to the thoracic cage to increase. Since the volume of the lungs does not instantly increase with a change in volume of the thorax, a transient drop in intra-thoracic (and intrapleural and intra-esophageal) pressures occurs. Decreased intra-thoracic pressure causes the volume of the lungs to expand, which causes air to enter the nostrils and/or mouth, to flow through the nasopharynx and oropharynx, the laryngopharynx, the larynx, the trachea, the bronchi, and, finally, the alveoli.

[0012] Mouth breathing refers to the state of inhaling and exhaling primarily through the mouth. A healthy individual normally breathes through the nose while resting or doing light exercise, and breathes simultaneously through both the nose and mouth during vigorous aerobic exercise, in order to supply sufficient oxygen for metabolic needs. Excessive mouth breathing causes problems because air is not filtered and warmed as much as when it is inhaled through the nose, as it bypasses the nasal canal and paranasal sinuses, and dries out the mouth. Mouth breathing is often associated with congestion, obstruction, or other abnormalities of the nasal passage ways. Everyone mouth breathes when the nose is stopped up by a cold. Mouth breathing is associated with obstructive sleep apnea.

[0013] The phayrnx is a complex fibromuscular tube which extends from the base of the skull to the origin of the esophagus. Portions of the pharynx lie posterior to the nasal cavity (nasal pharynx), oral cavity (oral pharynx), and larynx (laryngeal pharynx). The oral pharynx and laryngeal pharynx are shared for breathing and eating.

[0014] The muscular walls of the pharynx are formed of an outer layer made up of three circularly disposed muscles, the constrictors, and the inner muscular layer of the pharynx is made up of three small, longitudinally oriented muscles. During swallowing, successive contraction of the superior, middle, and inferior constrictor muscles helps to propel a bolus ball of food down into the esophagus. In addition, contraction of the three longitudinal muscles of the pharynx helps to raise the pharynx, effectively aiding it in engulfing the bolus of food. [0015] The pharynx contains a "ring" of specialized lymphatic tissue designed to prevent the entry of pathogens into the digestive and respiratory tracts. This specialized lymphatic tissue is known as "tonsils" and is organized into three groups: nasopharyngeal tonsils (adenoids), located in the nasal pharynx; palatine tonsils (tonsils), located between the palatoglossal and palatopharyngeal folds in the oral pharynx; and lingual tonsils, located on the posterior surface of - A -

the tongue.

[0016] Fresh air in the alveoli presents high gaseous oxygen concentration and low gaseous carbon dioxide concentration to blood in the proximal pulmonary capillaries. Carbon dioxide moves from the blood in the proximal pulmonary capillaries to air in the alveoli (carbon dioxide is "blown off) and oxygen moves from air in the alveoli to hemoglobin molecules in the blood of the proximal pulmonary capillaries. "Blue blood" in the proximal pulmonary capillaries becomes saturated, or "red blood", in the distal segments of these capillaries. Relaxation of the intercostals muscles, contraction of the muscles of the hemi-diaphragms, contraction of the muscles of the tongue, and relaxation of the muscles of the pharynx is a complex neuromuscular orchestration that occurs with each normal breath.

[0017] In addition, breathing centers in the medulla and pons integrate neural signals. The reticular formation, the nucleus retroambigualis, nucleus ambiguus, nucleus parambigualis, and the pre-Botzinger complex control voluntary forced exhalation and augment the force of inspiration. The nucleus tractus solitarius controls the timing of inspiratory movements. The pneumotaxic center fine tunes breathing rate, and the apneustic center in the lower pons controls breathing intensity. Further breathing integration occurs in the anterior horn cells of the spinal cord.

[0018] II. Sleep Apnea

[0019] "Apnea" is the technical term for suspension of breathing. During apnea there is no movement of the muscles of breathing and the volume of the lungs initially remains unchanged. Depending on the openness of the airways there may or may not be a flow of gas between the lungs and the environment. Apnea can be voluntarily achieved through breath-holding, drug- induced, mechanically induced (as in strangulation or obstructive sleep apnea), and caused by brain or spinal cord disease or injury (as in central sleep apnea). [0020] ILA. Definition of Sleep Apnea

[0021] Sleep apnea is a sleep disorder characterized by pauses in breathing during sleep. Each apneic event lasts long enough so that one or more breaths are missed. Missed breaths occur repeatedly throughout sleep. Sleep apnea is definitively diagnosed with an overnight sleep test called a "polysomnogram." An apneic event includes an absence of air flow for 10 second or longer, with either a neurological arousal (a 3-second or greater shift in EEG frequency) or a blood oxygen desaturation of 4% or greater, or both.

[0022] In addition to complete cessation of breathing, individuals with sleep apnea also exhibit smaller than normal breaths or "hypopneas." Hypopneas in adults are defined as a 50% reduction in air flow that occurs for more than 10 seconds, followed by a 4% desaturation in blood oxygen or neurological arousal, or both. Since both apneas and hypopneas are detrimental to sleep, the Apnea-Hypopnea Index (AHI) was created to measure the overall severity of sleep apnea by counting the number of apneas and hypopneas that occur per hour of sleep. The categorization of normal and abnormal states is shown in Table I.

Table I. Apenea-Hypopnea Index (AHI)

[0023] ILB. Signs and Symptoms of Sleep Apnea

[0024] 1. Frequent cessation of breathing (apnea) during sleep often noticed by one's sleep partner.

[0025] 2. Choking or gasping during sleep to get air into the lungs

[0026] 3. Loud snoring

[0027] 4. Sudden awakenings to restart breathing

[0028] 5. Waking up in a sweat during the night

[0029] 6. Feeling fatigued in the morning after a night's sleep

[0030] 7. Headaches, sore throat, or dry mouth in the mornings after waking up

[0031] 8. Exaggerated daytime sleepiness, including falling asleep at inappropriate times, such as during driving or at work [0032] Individuals with sleep apnea are rarely aware of having difficulty breathing, even upon awakening. Sleep apnea is recognized as a problem by others witnessing the individual during episodes or is suspected because associated abnormalities seen elsewhere in the body.

Symptoms may be present for years, even decades without identification, during which time the sufferer may become conditioned to the daytime sleepiness and fatigue associated with significant levels of sleep deprivation.

[0033] ILC. Risk factors of Sleep Apnea

[0034] 1. Nasal, oral, pharyngeal, or laryngeal anatomic or physiologic abnormalities including large tonsils or adenoids, chronic nasal congestion, deviated nasal septum, enlarged tongue, receding chin, enlarged soft palate, or lengthened uvula.

[0035] 2. Excess fat deposit surrounding the pharynx

[0036] 3. Family history of sleep apnea

[0037] 4. Old age

[0038] 5. Male gender (1, 2)

[0039] ILD. Sequela of Sleep Apnea

[0040] Mild, occasional sleep apnea, such as many people experience during an upper respiratory infection, may not be important. However, chronic, severe obstructive sleep apnea requires treatment to prevent sleep deprivation and other medical complications, including death.

[0041] ILD.1. Sleep Deprivation

[0042] Both the person with sleep apnea and the bed partner suffer from sleep deprivation. A bed partner may lose an hour or more of sleep each night from sleeping next to a person with sleep apnea. Along with the apnea episodes, the person afflicted with sleep apnea may have additional trouble sleeping caused by side effects of the condition, including a frequent need to get up and urinate during the night, and excessive nighttime sweating.

[0043] II.D.2. Oxygen Deprivation

[0044] When you stop breathing, your brain does not get enough oxygen. Drastic problems can result from the oxygen deprivation of sleep apnea, including premature death.

[0045] In some individuals, elevated systemic arterial pressure (commonly called high blood pressure) is a sequela of obstructive sleep apnea syndrome(3) When high blood pressure is caused by OSA, it is distinctive in that, unlike most cases of high blood pressure (so-called essential hypertension), the pressure readings do not drop significantly when the individual is sleeping. (4) OSA is associated with signs of cardiac ischemia and cardiac rhythm disturbances.

(5). Stroke and even premature death are associated with obstructive sleep apnea. (6)

[0046] Individuals suffering from OSA show brain tissue loss in regions that help store memory, thus linking OSA with memory loss. (7)

[0047] II.D.3. Metabolic Imbalances

[0048] Obstructive sleep apnea is associated with a range of metabolic abnormalities. (8-18).

For example, the hormone adiponectin is decreased in concentration in the serum in patients with sleep apnea. This hormone affects: glucose flu; gluconeogenesis; glucose uptake; lipid catabolism; b-oxidation; triglyceride clearance; insulin sensitivity; and protects endothelium from artherosclerosis.

[0049] II.D.4. Depression

[0050] Approximately one in five people who suffer from depression also suffer from sleep apnea, and people with sleep apnea are five times more likely to become depressed. Existing depression may also be worsened by sleep apnea. Treating sleep apnea may alleviate depression in some people.

[0051] ILE. Types of Sleep Apnea

[0052] There are three distinct forms of sleep apnea: obstructive; central; and mixed, which is a combination of the two. These three types comprise 84%, 0.4%, and 15% of cases, respectively. (19) Clinically significant levels of sleep apnea are defined as five or more episodes per hour of any type of apnea as identified on a polysomnogram. In obstructive sleep apnea, breathing is interrupted by a physical block to airflow despite contraction of the hemi- diaphragms. Breathing is interrupted by the absence of effort in central sleep apnea. In mixed sleep apnea, there is a transition from central to obstructive features during the apneic events themselves.

[0053] III. Obstructive Sleep Apnea (OSA)

[0054] The clinical picture of obstructive sleep apnea was first characterized as a personality trait and called the "Pickwickian syndrome." This term was coined by the famous early 20th Century physician, William Osier, to match the description of Joe, "the fat boy" in Dickens's novel, The Pickwick Papers. Dickens's description is an accurate clinical picture of the adult obstructive sleep apnea syndrome.

[0055] The early reports of obstructive sleep apnea in the medical literature described individuals who were very severely affected, often presenting with severe hypoxemia (low O₂), hypercapnia (increased CO₂) and congestive heart failure. Tracheostomy was the recommended treatment. Though it could be life-saving, post-operative complications in the tracheostomy stoma were frequent in these very obese and short-necked individuals. That a tracheotomy can effectively treat even severe obstructive sleep apnea implies that the anatomic site or sites of obstruction of the airway during sleep are above or superior to the level of the trachea.

Historically, however, tracheostomies have involved the implantation of devices inside the trachea, which impedes air movement and can induce other complications.

[0056] III.A. Sites of Obstruction

[0057] Obstruction of the airway at the level of the nasal cavity, the anterior tongue, the bony jaw, the tonsils, and the adenoids are relatively straightforward to diagnose and can often be accurately identified clinically. The real difficulty in obstructive sleep apnea is identifying the level of obstruction in the pharynx during sleep. Normally, muscles in the body relax during sleep, including those of the pharynx. When relaxed the pharynx is composed of collapsible walls of soft tissue which can obstruct breathing. During each breath, the muscles of the pharynx contract in a coordinated fashion to "open" the pharynx and allow air to flow through.

[0058] The pharynx can be identified by lateral radiography, computed tomography (CT), magnetic resonance imaging (MRI), and fluoroscopy.(20) Of these modalities, CT and MRI provide cross sectional images and are the most accurate measurements of pharyngeal narrowing.

[0059] III.A.1. Oropharynx

[0060] Many studies of patients with obstructive sleep apnea have placed the primary locus of obstruction in the oropharynx. (21-25)

[0061] III.A.2. Nasopharynx

[0062] Other studies place the primary site of pharyngeal narrowing superior to the oropharynx. (26, 27)

[0063] III.A.3. Diffuse

[0064] Still others have found that pharyngeal obstruction can be at one location in one individual and at another location is a different person. (28-31)

[0065] III.B. Treatment

[0066] III.B.1. Minor Treatments

[0067] III.B. l.a). Lifestyle Changes

[0068] Alcohol avoidance, cessation of the use of muscle relaxants and sleep medications, weight loss, and quitting smoking may each diminish the severity of obstructive sleep apnea.

Life style changes are most effective in patients with mild obstructive sleep apnea.

[0069] III.B. l.b). Dental Appliances

[0070] Some people benefit from various kinds of oral appliances to keep the upper airway open during sleep. An oral appliance is a custom made mouthpiece that shifts the jaw forward to help keep the pharynx open during sleep. Oral appliance therapy is usually successful in patients with mild to moderate obstructive sleep apnea.

[0071] III.B. l.c). Sleep Posture

[0072] Many people benefit from a change of sleep posture. (32-37) For example, sleeping at a 30 degree elevation of the upper body or higher, or sleeping on one's side, may help to prevent the gravitational collapse of the phayrngeal airway.

[0073] III.B. l.d). Medication

[0074] Medications like Acetazolamide lower blood pH and encourage breathing. Low doses of oxygen are also used as a treatment for hypoxia.

[0075] III.B. l.e). Wind Instruments

[0076] A recent study found that learning and practicing the didgeridoo wind instrument helped reduce snoring and sleep apnea, as well as daytime sleepiness. This appears to work by strengthening muscles in the upper airway, thus reducing their tendency to collapse during sleep.(38)

[0077] III.B.2. Major Treatments

[0078] III.B.2.a) Continuous Positive Airway Pressure (CPAP) [0079] III.B.2.a).(l) CPAP Benefits

[0080] The management of obstructive sleep apnea was revolutionized with the introduction of continuous positive airway pressure by Sullivan. (39-42) The first models were bulky and noisy but the design was rapidly improved and, by the late 1980s, CPAP was widely adopted.

The availability of an effective treatment stimulated an aggressive search for affected individuals and led to the establishment of hundreds of specialized clinics dedicated to the diagnosis and treatment of sleep disorders. The vast majority of patients who attend a sleep clinic suffer from a sleep apnea.

[0081] III.B.2.a).(2). CPAP Failures

[0082] Though CPAP therapy has brought relief from obstructive sleep apnea to many, it is not without complications. Table II lists the common complaints made by patients on CPAP therapy.

Table II. Common problems reported with nasal continuous positive airway pressure and trouble- shooting guide

[0083] III.B.2.b). Surgery

[0084] Specific types of surgery can increase the size of the pharyngeal, oral, and nasal airways by removing or reshaping tissues. (43) A surgeon may remove tonsils, adenoids, or excess tissue at the back of the throat or inside the nose. A surgeon may even reconstruct the jaw to enlarge the pharynx.

[0085] IV. Central Apnea

[0086] Any individual, no matter how healthy, when given enough of a central respiratory depressant, will develop central apnea. In large amounts, alcohol is a central respiratory depressant, and so are opiates, barbiturates, benzodiazepines, and many other tranquilizers and sleep aids.

[0087] Central sleep apnea (CSA), the rarest type of sleep apnea, occurs when the brain signals that instruct the body to breathe are delayed. This central nervous system disorder can be caused by disease or injury involving the brainstem, such as a stroke, a brain tumor, a viral brain infection, or a chronic respiratory disease. People with CSA seldom snore, which makes it even harder to diagnose as they do not fit the "normal" profile of a sleep apnea sufferer. However, while the causes of the breathing cessation are different in central sleep apnea and obstructive sleep apnea, the symptoms and results are much the same. Patients are deprived of oxygen and repeatedly awaken at night. The treatments for CSA include specific medications that stimulate the need to breathe and administrations of oxygen.

[0088] Central sleep apnea usually occurs most commonly in people who are seriously ill.

For example, it can occur in people with a variety of severe and life-threatening lower brain stem lesions. Since the brainstem controls breathing, any disease or injury affecting it may result in apnea, even when awake.

[0089] Conditions that can cause central sleep apnea include:

[0090] 1. Bulbar poliomyelitis

[0091] 2. Encephalitis affecting the brainstem

[0092] 3. Neurodegenerative illnesses

[0093] 4. Stroke affecting the brainstem

[0094] 5. Cervical spine injury

[0095] IV.A. Definition

[0096] In pure central sleep apnea, the brain's respiratory control centers do not function normally during sleep. The concentration of carbon dioxide in the blood and the neurological feedback mechanism that monitors it do not react quickly enough to maintain an even respiratory rate, with the entire system cycling between apnea and rapid breathing (hyperpnea), even during wakefulness. The sleeper stops breathing, and then starts again. There is no effort made to breathe during the pause in breathing; there are no chest movements and no struggling. After an episode of apnea, breathing may be faster for a period of time, a compensatory mechanism to blow off carbon dioxide and absorb more oxygen.

[0097] The immediate effects of central sleep apnea on the body depend on how long the failure to breathe endures. At worst, central sleep apnea may cause sudden death. Short of death, drops in blood oxygen may trigger seizures - even in the absence of epilepsy. In people with epilepsy, the hypoxia caused by apnea may trigger seizures that had previously been well controlled by medications. In other words, a seizure disorder may become unstable in the presence of sleep apnea. In adults with coronary artery disease, a severe drop in blood oxygen level can cause angina, arrhythmias, or myocardial infarction. Longstanding recurrent episodes of apnea, over months and years, may cause an increase in carbon dioxide levels that can change the pH of the blood enough to cause a metabolic acidosis.

[0098] IV.B. Treatment

[0099] IV.B.l. Stop CNS Depressant Drugs

[0100] IV.B.2. Pace the Diaphragms

[0101] When central apnea is severe, the diaphragm can be artificially paced with electrical currents (Synapse Biomedical, Inc, Oberlin, OH). Surgically implanted electrodes electrically stimulate the phrenic nerve or the muscles of the hemi-diaphragms, directly. Wires from the electrodes in the diaphragm run to and from a control box worn outside the body. The pacing is performed according to a reconditioning program in which the duration and frequency of electrode stimulation is gradually increased until full-time diaphragm pacing is achieved. When the electrodes are stimulated by current, the diaphragm contracts and air is sucked into the lungs

(inspiration). When the electrodes are not stimulated, the diaphragm relaxes and air moves out of the lungs (expiration).

[0102] V. Mixed Apnea and Complex Sleep Apnea

[0103] Some people with sleep apnea have a combination of obstructive and central sleep apnea. (19) When obstructive sleep apnea is severe and longstanding, episodes of central apnea sometimes develop. The exact mechanism of the loss of central respiratory drive during sleep in obstructive sleep apnea is unknown.

[0104] Complex sleep apnea has recently been described by researchers as a novel presentation of sleep apnea. Patients with complex sleep apnea exhibit OSA, but upon application of positive airway pressure, the patient exhibits persistent central sleep apnea. This central apnea is most commonly noted while on CPAP therapy, after the obstructive component has been eliminated.

[0105] VI. Conclusion

[0106] What is needed in sleep apnea is an integrated medical device system that can treat all forms of sleep apnea with minimal interference with a person's night-time sleeping experience.

[0107] Two primary problems exist for patients with sleep apnea: absence of breathing effort and obstruction of air flow. Absence of breathing effort can be treated with electrical pacing of the diaphragm. Obstruction of air flow can be treated with bypass of the pharynx, oral cavity, and nasal cavity airways, as in the creation of a tracheostomy, or by briefly opening obstructive zones within the upper airway with electrical stimulation of the muscles at the site or sites of obstruction. To be effective, the pacing of the diaphragms and the pacing of upper airway muscle contractions would have to be coordinated. The pacing of the diaphragms and bypass of the upper airway would not have to be coordinated.

SUMMARY

[0108] According to a first aspect of the invention, a tracheostomy device comprises an exo- tracheal flange having a proximal end, a distal end, and a bore extending completely through the flange from the proximal end to the distal end, the flange including a pair of laterally extending wings positioned at the flange distal end, a skin port having a proximal end, a distal end, and a bore extending completely through the skin port from the proximal end to the distal end and a bridge tube releasably connecting the flange proximal end to the skin port distal end and having a bore fluidly communicating the flange bore with the skin port bore. [0109] According to another aspect of the present invention, a tracheostomy device comprises a flange having a bore extending through the flange, and at least one of: an elongate tubular fitting having a proximal end, a distal end, and a lumen extending between the ends, the fitting distal end releasably attached to the flange with the fitting lumen in fluid communication with the flange bore, optionally further including a cover configured and arranged to be received by the fitting proximal end; a cap sized to be received at least partially in the flange bore, the cap including a throughbore; a cap sized to be received at least partially in the flange bore, the cap sealing the flange bore and preventing fluid communication with the environment; and a cap sized to be received at least partially in the flange bore, the cap including a throughbore and a proximal skirt having a lateral dimension greater than a lateral dimension of the flange. [0110] According to yet another aspect of the present invention, a method of treating a patient suffering from apnea comprises implanting a flange adjacent at least partially below the skin of the patient and outside of the trachea of the patient, the flange having a throughbore; and forming a stoma in the patient's trachea immediately adjacent to the flange, such that the stoma is in direct air communication with the environment through the bore of the flange.

[0111] Still other aspects, features, and attendant advantages of the present invention will become apparent to those skilled in the art from a reading of the following detailed description of embodiments constructed in accordance therewith, taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0112] The invention of the present application will now be described in more detail with reference to exemplary embodiments of the apparatus and method, given only by way of example, and with reference to the accompanying drawings, in which:

[0113] Fig. 1 illustrates a cross-sectional view of portions of the neck of a human patient, including the trachea, esophagus, and adjacent tissues;

[0114] Fig. 2 illustrates a view similar to Fig. 1, with a first exemplary embodiment of a device of the present invention in situ;

[0115] Fig. 3 illustrates the embodiment of Fig. 2 after surgically opening the stoma;

[0116] Fig. 4 illustrates a cross-sectional view of a first exemplary closure device for the device illustrated in Figs. 2 and 3;

[0117] Fig. 5 illustrates a cross-sectional view of a second exemplary closure device for the device illustrated in Figs. 2 and 3;

[0118] Fig. 6 illustrates a cross-sectional view of a third exemplary closure device for the device illustrated in Figs. 2 and 3;

[0119] Fig. 7 illustrates a sagittal sectional view of a portion of yet another embodiment;

[0120] Fig. 8 illustrates a sagittal sectional view of a portion of another embodiment;

[0121] Fig. 9 illustrates sagittal sectional view of a portion of yet another embodiment;

[0122] Fig. 10 illustrates a coronal sectional view, taken through the patient's neck, of another exemplary embodiment; [0123] Fig. 11 illustrates a front elevational view of the embodiment of Fig. 11 ;

[0124] Fig. 12 illustrates a sagittal sectional view of portions of the human neck, including a portion of another exemplary embodiment implanted adjacent to the trachea;

[0125] Fig. 13 illustrates a sagittal sectional view similar to that of Fig. 12, including additional portions of that exemplary embodiment;

[0126] Fig. 14 illustrates a sagittal sectional view similar to those of Figs. 12 and 13, and including another exemplary embodiment of a system implanted between the trachea and skin of the patient;

[0127] Fig. 15 illustrates a partial sagittal sectional view, partial left side elevational view, of portions of a human head including other portions of the system illustrated in Fig. 14;

[0128] Fig. 16 illustrates a front elevational view of the neck of the patient, including portions of the system of Fig. 14;

[0129] Fig. 17 illustrates a top, front, right perspective view of yet another exemplary embodiment of a device in accordance with the present invention;

[0130] Fig. 18 illustrates a front plan view of the device of Fig. 17;

[0131] Fig. 19 illustrates a left or right side elevational view of the device of Fig. 17;

[0132] Fig. 20 illustrates a cross- sectional view taken at line A-A of Fig. 19;

[0133] Fig. 21 illustrates an exploded perspective view of the device of Fig. 17;

[0134] Fig. 22 illustrates an exploded left or right side elevational view of the device of Fig.

17; and

[0135] Fig. 23 illustrates a cross- sectional view taken at line B-B of Fig. 22.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

[0136] Referring to the drawing figures, like reference numerals designate identical or corresponding elements throughout the several figures.

[0137] Fig. 1 illustrates a cross-sectional view of portions of the neck of a human patient, including the trachea Tr, esophagus E, and adjacent tissues including the tongue T, vocal cords VC, tracheal cartilage TrC, and thyroid cartilage ThC. [0138] An exemplary tracheostomy system is illustrated after having been surgically implanted into the patient, and includes an exotracheal cuff 10 and a flange 12 attached to the cuff. The flange 12 includes a central bore 14 extending from a distal surface 16 to a proximal surface 18 which fluidly communicates the interior of the trachea with the outer portions of the flange and, when those outer portions are positioned outside the skin S of the patient, the environment. The cuff 10 may optionally encircle the trachea, but according to other embodiments of the present invention, the cuff does not entirely encircle the trachea. The cuff 10 and the flange 12 are preferably configured as a unit that is implanted, although they can be configured as separate components. Further optionally, the cuff 10 can be eliminated and the flange 12 can be sufficient for attachment to the patient.

[0139] Fig. 1 also illustrates, by a broken line, the location of a stoma or opening into the trachea which may be created at the time of the second surgery to perform the "skin ostomy", but which is illustrated closed in the figure and thus before the opening has been surgically formed. The exotracheal cuff 10, when included, can act as an adjunct for incorporation of the device into the patient' s body, and is formed of a suitable material, for example, dacron mesh or an expanded PTFE structure to allow tissue ingrowth.

[0140] The flange 12 is formed of a biocompatible solid material that will not be resorbed by the patient's body, such as, but not limited to, titanium and certain of its alloys, surgical stainless steel, certain polymers, certain ceramics, and combinations of these materials, as are well known to those in the art for use in implanted devices.

[0141] Turning now to Fig. 4, a first exemplary embodiment of a cap is illustrated. The cap 20 includes an elongate stem 22 sized to be received, advantageously with little or no clearance, in the bore 14. Optionally, the inner surface of the bore 14 and the outer surface of the stem 22 can be tapered, threaded, or the like, to permit the two structures to be releasable mated together. The cap 20 also includes a flange 24 on the proximal side of the cap, which is laterally larger than the stem 22 and is advantageously laterally bigger than the inner diameter of the bore 14. A throughbore 26 extends through the stem 22 and flange 24. When installed in the bore 14, the cap 20 partially closes the bore 14 while still permitting air to pass between the trachea and the environment and, thus, the patient to have an auxiliary airway. [0142] Fig. 5 illustrates a second exemplary embodiment of a cap according to principles of the present invention. The cap 30 is a solid piece which seals off the bore 14, when installed in the bore. The cap 30 includes a stem 32 having an optional, laterally extending seal 34 on a distal end of the stem, and a laterally extending flange 36 on a proximal end of the stem. Alternatively, as with the cap 20, the stem 32 can be tapered, threaded, or the like. The flange 36 is advantageously laterally bigger than the inner diameter of the bore 14.

[0143] Fig. 6 illustrates a third exemplary embodiment of a cap according to principles of the present invention. The cap 40 includes structure similar in many respects to those of the cap 20. The cap 40 includes an elongate stem 42 sized to be received, advantageously with little or no clearance, in the bore 14. Optionally, the inner surface of the bore 14 and the outer surface of the stem 42 can be tapered, threaded, or the like, to permit the two structures to be releasable mated together. The cap 40 includes a proximal flange 46, which can be laterally larger than the stem 42 and is advantageously laterally bigger than the inner diameter of the bore 14. A throughbore 44 extends through the stem 42 and the flange 46. A proximal skirt 48 extends proximally from the flange 46, and includes a large central opening 50 that is in communication with the bore 44. The skirt 48 is formed of a relatively rigid material, and is provided to inhibit or prevent obstruction of the bore 44 by clothing or folds of the patient's skin. When installed in the bore 14, the cap 40 partially closes the bore 14 while still permitting air to pass between the trachea and the environment and, thus, the patient to have an auxiliary airway.

[0144] According to an exemplary method embodying principles of the present invention, in a first step, an exotracheal (outside of or exterior to the trachea) tube or cuff is surgically implanted around some or all of the circumference of the trachea of a (human) patient. A flange having a through-bore is attached to the cuff, or the flange is formed integrally with the cuff and is thus implanted when the cuff is implanted. Alternatively, the flange itself is sufficient to anchor to the trachea and no cuff is used. The cuff and/or flange are oriented so that the flange is adjacent to the front of the patient's neck. The patient's skin is then closed over the cuff and/or flange, and the surgical site and the patient's skin are allowed to heal, which may take between 6-12 weeks. [0145] In a second step of the exemplary method, and after the surgical site and skin have healed (see Fig. 2), the site is surgically reopened. A stoma is surgically formed in the patient's trachea, that is, a tracheostomy is performed, below the thyroid gland, with the stoma aligning with the bore of the previously implanted flange. The tissues adjacent to the stoma are sutured, cauterized, or otherwise sealed to the cuff and/or the flange. While less preferable, optionally an additional and separate portion of the flange (not illustrated) is positioned inside the trachea and is attached to the rest of the flange, e.g., by screw-threaded or snap-fit structures on the two portions of the flange, to assist in holding the flange in place. The patient's skin at the proximal face of the flange is then held to the proximal face of the flange, so that the proximal end of the flange's bore can easily communicate with the environment (see Fig. 3). [0146] In a third step, after the flange's bore has been opened to the environment, a removable closure device is mounted to the proximal face of the flange, which covers and seals the flange bore and, thus, seals the stoma to the trachea. The wound site is then allowed to heal. [0147] In use, a patient suffering from apnea installs a cap having a throughbore into the bore of the flange, and goes to sleep. The bores of the flange and of the cap provide an auxiliary airway for the patient, and thus can inhibit apnea episodes from disturbing the patient's sleep. [0148] Figures 7-11 illustrate several views of yet additional exemplary embodiments. Fig. 7 illustrates a fitting 80 having a threaded stem 82 and an outer portion 84. A bore 86 extends through the stem 82 to at least one, and preferably two, transverse bores 88 that extend through the outer portion 84. The bore 86 is in fluid communication with the interior of the flange attached to the patient, as described elsewhere herein, and is thus in fluid communication with the trachea. As described with reference to Fig. 10, the fitting 80 permits establishment of an air path to the trachea that exits the patient and communicates with the environment at a location remote from the flange and the fitting 80.

[0149] Fig. 8 illustrates yet another embodiment of a fitting embodying principles of the present invention, which permits direct bypass of the patient's airway to the trachea. A fitting 100 includes a hollow stem 102 that mates with the implanted, exotracheal flange, with the stem extending through the patient's skin S. The stem has an internal bore 106 that thus communicates the trachea to the environment. The external portions of the stem include locking and sealing structures 104 to which additional accessories can sealingly mate. By way of example and not of limitation, accessories can include a liquid-tight cover 108, a T-shaped hollow coupling that fits into the stem 102, and the like, preferably formed of a material softer than that of the stem.

[0150] Turning now to Figs. 9 and 11, exotracheal flanges in accordance with principles of the present invention can alternatively include an external thread 120, to which a threaded cap 122 can be secured, for temporary or permanent closure of the flange, for example, after implantation of the flange.

[0151] Fig. 10 illustrates additional exemplary systems and methods embodying principles of the present invention. Also with reference to the embodiment illustrated in Fig. 7, a system 140 includes the fitting 80 in fluid communication with at least one, and preferably two or more, implanted air tubes or pathways 142, 144, or at least one, and preferably two or more, subcutaneous air tubes or pathways 146, 148; the air pathways can be formed of biocompatible polymer or metal tubing. When utilizing the pathways 146, 148, the pathways are implanted so that they tunnel sub-cutaneously behind the patient's ears E or at the patient's hairline, and exit at locations closer to the back of the patient's neck, as an alternative to the ostomy being open in the front. Cosmetically, such an approach may be more desirable for some patients. For both the internal and external pathways, the end(s) of the pathways can be structures formed in the same manner as the various exotracheal flanges described herein, and thus can include fittings 150 that can include fluid-tight fittings and air-filter fittings for nighttime use. Air pathways 142, 144 involve more invasive tunneling methods into either the nasal cavity or the mouth, both indicated generally by the anatomical structures within the dotted line in the center of Fig. 11. [0152] Fig. 12 illustrates a sagittal sectional view of portions of the human neck, including a portion 162 of another exemplary embodiment implanted adjacent to the trachea Tr. As described in greater detail elsewhere herein, a section of an apnea treatment system is implanted immediately adjacent to or on the exterior of the trachea Tr, and is later connected to other portions of the system to form a supplemental air pathway which can be effective to inhibit apnea in a patient.

[0153] Fig. 13 illustrates a sagittal sectional view similar to that of Fig. 12, including additional portions of that exemplary embodiment 160. As illustrated in Fig. 13, the portion 162, which was attached adjacent to or on the exterior of the trachea Tr, is mechanically and fluidly connected to another portion which is attached to the skin of the patient, so that a supplemental air passage is selectively established between the trachea and the environment.

[0154] Fig. 14 illustrates a sagittal sectional view similar to those of Figs. 12 and 13, and including portions 190 of another exemplary embodiment of a system implanted between the trachea Tr and skin of the patient. Similar to the system 140 described elsewhere herein, the portion 190 includes tubes 142/144 and 146/148, which extend from a fitting 80 to remote portions of the systems which are in fluid communication with the environment, and thus also establish supplemental air passageways. The fitting 80 is connected to a portion of the system which is attached to the trachea Tr, as described elsewhere herein, and thus can conduct air from the remote portions of the system to the trachea.

[0155] Fig. 15 illustrates a partial sagittal sectional view, partial left side elevational view, of portions of a human head including other remote portions of the system illustrated in Fig. 14. As described with reference to Fig. 14, the tube 142/146 extends beneath the skin of the patient from the fitting 80 to one or more external skin ports 150 which can be similar to other skin ports described herein. While the exact location of the ports 150 can be selected based on patient or practitioner preference, Fig. 15 illustrates one exemplary location, below and behind the patient's ear.

[0156] Fig. 16 illustrates a front elevational view of the neck of the patient, including the fitting 80 and tubes 142/146, 144/148 of the system of Fig. 14, illustrated to show the exemplary relative placement of these portions of the system even though they are positioned below the surface of the patient's skin.

[0157] Figs. 17-23 illustrate several view of another exemplary embodiment 160 of a device in accordance with the present invention, of which Fig. 17 is a top, front, right perspective view.

The device 160 includes a tracheal attachment section 162, a cap section 164, and an intermediate connector section 166 which connects together the sections 162, 164, both mechanically and fluidly.

[0158] Fig. 18 illustrates a front plan view of the device 160 of Fig. 17. The cap section 164 includes a skin port 170, a tube or annular ring 172 which assists in tissue and/or bone ingrowth positioned distal of the port 170, and a laterally and circumferentially extending flange or collar 174. The flange 174 is provided to also assist in developing tissue ingrowth and to help stabilize the skin port 170, and can optionally be formed of a titanium mesh material. A bridging tube 178 extends from the location of the flange 174 distally towards the tracheal attachment section 162, where a seal 182 is positioned. According to certain embodiments of the device 160, the tracheal attachment section 162 includes one or more exo-tracheal attachment flanges 180 which extend radially away from the bridge tube 178 and seal 182. Not illustrated in Fig. 18, but illustrated in other drawing figures, the device 160 includes a lumen or throughbore which extends through the device and thus can establish an air passageway as described herein, with the plug 168 removably, and thus selectively, plugging the lumen.

[0159] Figs. 19-21 illustrate several additional views of the device 160, in which Fig. 19 illustrates a left or right side elevational view of the device of Fig. 17, Fig. 20 illustrates a cross- sectional view taken at line A-A of Fig. 19, and Fig. 21 illustrates an exploded perspective view of the device of Fig. 17. As described above, the subcomponents of device 160, and therefore the device itself, each includes a through bore or hole, which together define a lumen 176 through the device 160 as illustrated in Fig. 20.

[0160] Figs. 22 and 23 illustrate two additional views of the device 160, in which Fig. 22 illustrates an exploded left or right side elevational view of the device of Fig. 17, and Fig. 23 illustrates a cross-sectional view taken at line B-B of Fig. 22. With reference to both figures, the plug 168 includes a proximal portion 190 which is sized and configured to be easily grasped by human fingers so that the plug 168 can be manipulated to selectively plug and unplug the device 160. The plug 168 can optionally further include a tether (not illustrated) connecting the plug to other portions of the device 160 outside of the patient's skin, such as the skin port 170. Further optionally, the plug 168 and skin port 170 can include or be formed of a magnetic material so that the two structures attract each other, thus also assisting in inhibiting the plug 168 from falling out of the skin port 170.

[0161] The plug 168 further includes a radially extending flange 192, and a stopper 194 on the side of the flange 192 opposite the grasping portion 190. The stopper 194 is advantageously shaped complementary to corresponding portions of the skin port 170, described in greater detail below, so that the stopper can form an airtight and fluid tight seal with the skin port. While any of a number of geometries is acceptable according to principles of the present invention, a frustoconical shape for the stopper 194 has certain advantages.

[0162] The skin port 170, as its name indicates, is to be attached to or implanted in the patient with portions of the skin port outside of, and acts as a port through, the patient's skin. The skin port 170 includes a radially extending proximal flange 200, a reduced diameter section immediately adjacent to the flange 200 and forming a circumferential shoulder 202, and a distal tube 204 of yet smaller radial dimension. The tube 204 includes structures which permit the skin port 170 to be firmly attached to further portions of the device 160. By way of non-limiting example, threads 206 are provided on the exterior of the tube 204, which are configured to mate with corresponding internal threads on another portion of the device 160, described below. The skin port 170 also includes, as discussed above, at least one lumen 208 extending completely through the skin port between its proximal to distal ends. Advantageously, yet still optionally, the skin port 170 is formed of titanium or polyetheretherketone (PEEK). [0163] The ring 172 both assists in bone and tissue ingrowth, and, as illustrated in Fig. 20, captures the flange 174 between the skin port 170 and the bridging tube 178. Advantageously, the ring 172 is formed of, or coated at least on the exterior portions, a material that encourages tissue and/or bone ingrowth, such as hydroxylapatite, so that the skin port 170 is effectively anchored to the skin. The ring 172 includes a lumen 210.

[0164] The flange 174, as discussed above, is radially larger than the other structures, and therefore assists in stabilizing the device when it is implanted in a patient. While illustrated as being entirely disk-shaped, the flange 174 can have other shapes, including discontinuous shapes such as numerous radially extending fingers. Forming the flange of a material into which tissue can grow also assists in stabilizing the device 160 in the patient.

[0165] The bridging tube 178 performs several functions for which its structure is adapted. The tube 178 includes a body 220 which, at its proximal end, includes a bore 224 which has a structure which can mate with a corresponding structure on the distal tube 204 of the skin port 170; according to an exemplary embodiment, the bore 224 is internally threaded 226, so that the tube 178 can be attached to the skin port, capturing the ring 172 and flange 174 therebetween. For capturing the ring 172 and flange 174, the exterior of the proximal end of the tube 178 includes a reduced lateral section, which forms a shoulder 226. As with the other subcomponents of the device 160, the body 220 includes a lumen 222 extending completely between its proximal and distal ends, and thus can form part of an air passageway. The distal end of the body 220 includes a bore 228 and a structure which permits it to mate with a corresponding structure on the exo-tracheal flange 180; in this exemplary embodiment, the bore 228 includes internal threads 230. Depending on the relative lateral dimensions of the several subcomponents of the device 160, the body 220 can include an external change in lateral size, e.g., at a tapered shoulder 232. The overall length of the tube 178 is advantageously selected for each patient so that the exo-tracheal flange 180 is adequately and comfortably connected to the skin port 170. While other materials can be used, the tube 178 is advantageously formed of silicone.

[0166] The exo-tracheal flange 180 includes a tubular body 242 having a central lumen 242 which extends completely from the proximal to the distal ends of the tube. The external surface of the tube 242 includes structure which mates with the corresponding structure on the distal end of the bridging tube 178; in this exemplary embodiment, the tube 242 includes an external thread which mates with the corresponding thread 230. At least two, and optionally more, laterally extending flanges or wings 248, 250 extend from the distal end of the tube 242 which are configured to be attachable to the exterior of the trachea Tr. In this exemplary embodiment, two diametrically opposite flanges are provided which extend both laterally and distally away from the tube 242, so that the distal faces of the flanges can engage and be secured to the curved outer surface of the trachea without greatly distorting the shape of the trachea. According to some embodiments, the distal surfaces of the wings 248, 250 and of the tube 242 are concave, and further optionally can be formed at a radius R. As can also be seen in Fig. 22, the wings 248, 250 include one or more holes 252, 254 which permit the practitioner to suture the wings to the trachea. Because the trachea is a generally tubular anatomical structure, if additional wings are provided circumferentially between the wings 248, 250, they should be configured to generally conform to the shape of a tube so as to not distort the trachea. Advantageously, yet still optionally, the exo-tracheal flange 180 is formed of titanium or polyetheretherketone (PEEK). [0167] The optional seal 182 includes a washer- like body having a central hold 240, and is positioned between the distal end of the bridge tube 178 and the proximal end of the exo-tracheal flange 180.

[0168] The device 160 is particularly advantageously assembled from at least two, and optionally several, subcomponents, so that the exo-tracheal flange portion can be first attached to the trachea, and then the surgical site closed and permitted to heal, before the rest of the device is attached to the exo-tracheal flange. While less preferable, other exemplary embodiments can be formed as monolithic, integral structures and all implanted during a single surgery. While numerous materials can be used to form the various structures, the implanted subcomponents must be formed of biocompatible, implantable material.

[0169] While the invention has been described in detail with reference to exemplary embodiments thereof, it will be apparent to one skilled in the art that various changes can be made, and equivalents employed, without departing from the scope of the invention. The foregoing description of the preferred embodiments of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed, and modifications and variations are possible in light of the above teachings or may be acquired from practice of the invention. The embodiments were chosen and described in order to explain the principles of the invention and its practical application to enable one skilled in the art to utilize the invention in various embodiments as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims appended hereto, and their equivalents. The entirety of each of the documents referenced herein is incorporated by reference. [0170] Reference List

[0171] 1. Hader C, Schroeder A, Hinz M, Micklefield GH, Rasche K. Sleep disordered breathing in the elderly: comparison of women and men. J Physiol Pharmacol 56 Suppl 4:85-91, 2005.

[0172] 2. Shepertycky MR, Banno K, Kryger MH. Differences between men and women in the clinical presentation of patients diagnosed with obstructive sleep apnea syndrome. Sleep 28:309-14, 2005. [0173] 3. Silverberg DS, Iaina A, Oksenberg A. Treating obstructive sleep apnea improves essential hypertension and quality of life. Am Fam Physician 65:229-36, 2002. [0174] 4. Grigg-Damberger M. Why a polysomnogram should become part of the diagnostic evaluation of stroke and transient ischemic attack. J Clin Neurophysiol 23:21-38, 2006.

[0175] 5. Alonso-Fernandez A, Garcia-Rio F, Racionero MA, Pino JM, Ortuno F,

Martinez I, Villamor J. Cardiac rhythm disturbances and ST-segment depression episodes in patients with obstructive sleep apnea-hypopnea syndrome and its mechanisms. Chest 127:15-22, 2005.

[0176] 6. Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V.

Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med 353:2034-41, 2005. [0177] 7. Kumar R, Birrer BV, Macey PM, Woo MA, Gupta RK, Yan-Go FL,

Harper RM. Reduced mammillary body volume in patients with obstructive sleep apnea. Neurosci Lett 438:330-4, 2008.

[0178] 8. Magalang UJ, Cruff JP, Rajappan R, Hunter MG, Patel T, Marsh CB,

Raman SV, Parinandi NL. Intermittent Hypoxia Suppresses Adiponectin Secretion by Adipocytes. Exp Clin Endocrinol Diabetes2008.

[0179] 9. Nakagawa Y, Kishida K, Kihara S, Sonoda M, Hirata A, Yasui A,

Nishizawa H, Nakamura T, Yoshida R, Shimomura I, Funahashi T. Nocturnal reduction in circulating adiponectin concentrations related to hypoxic stress in severe obstructive sleep apnea- hypopnea syndrome. Am J Physiol Endocrinol Metab 294:E778-84, 2008. [0180] 10. Han F. Obstructive sleep apnea hypopnea syndrome: a proinflammatory disorder. Chin Med J (Engl) 120:1475-6, 2007.

[0181] 11. Harsch IA, Bergmann T, Koebnick C, Wiedmann R, Ruderich F, Hahn

EG, Konturek PC. Adiponectin, resistin and subclinical inflammation— the metabolic burden in Launois Bensaude Syndrome, a rare form of obesity. J Physiol Pharmacol 58 Suppl 1:65-76, 2007.

[0182] 12. Alam I, Lewis K, Stephens JW, Baxter JN. Obesity, metabolic syndrome and sleep apnoea: all pro -inflammatory states. Obes Rev 8:119-27, 2007. [0183] 13. Sharaia SK, Kumpawat S, Goel A, Banga A, Ramakrishnan L, Chaturvedi

P. Obesity, and not obstructive sleep apnea, is responsible for metabolic abnormalities in a cohort with sleep-disordered breathing. Sleep Med 8:12-7, 2007.

[0184] 14. Masserini B, Morpurgo PS, Donadio F, Baldessari C, Bossi R, Beck-

Peccoz P, Orsi E. Reduced levels of adiponectin in sleep apnea syndrome. J Endocrinol Invest

29:700-5, 2006.

[0185] 15. Makino S, Handa H, Suzukawa K, Fujiwara M, Nakamura M, Muraoka S,

Takasago I, Tanaka Y, Hashimoto K, Sugimoto T. Obstructive sleep apnoea syndrome, plasma adiponectin levels, and insulin resistance. Clin Endocrinol (Oxf) 64:12-9, 2006.

[0186] 16. WoIk R, Svatikova A, Nelson CA, Garni AS, Govender K, Winnicki M,

Somers VK. Plasma levels of adiponectin, a novel adipocyte-derived hormone, in sleep apnea.

Obes Res 13:186-90, 2005.

[0187] 17. Zhang XL, Yin KS, Mao H, Wang H, Yang Y. Serum adiponectin level in patients with obstructive sleep apnea hypopnea syndrome. Chin Med J (Engl) 117:1603-6, 2004.

[0188] 18. Zhang XL, Huang QS, Huang M, Yin KS. [Serum adiponectin levels in patients with obstructive sleep apnea-hypopnea syndrome]. Zhonghua Jie He He Hu Xi Za Zhi

27:515-8, 2004.

[0189] 19. Morgenthaler TI, Kagramanov V, Hanak V, Decker PA. Complex sleep apnea syndrome: is it a unique clinical syndrome? Sleep 29:1203-9, 2006.

[0190] 20. Thakkar K, Yao M. Diagnostic studies in obstructive sleep apnea.

Otolaryngol Clin North Am 40:785-805, 2007.

[0191] 21. Lowe AA, Gionhaku N, Takeuchi K, Fleetham JA. Three-dimensional CT reconstructions of tongue and airway in adult subjects with obstructive sleep apnea. Am J

Orthod Dentofacial Orthop 90:364-74, 1986.

[0192] 22. Galvin JR, Rooholamini SA, Stanford W. Obstructive sleep apnea: diagnosis with ultrafast CT. Radiology 171:775-8, 1989.

[0193] 23. Stauffer JL, Zwillich CW, Cadieux RJ, Bixler EO, Kales A, Varano LA,

White DP. Pharyngeal size and resistance in obstructive sleep apnea. Am Rev Respir Dis

136:623-7, 1987. [0194] 24. Avrahami E, Solomonovich A, Englender M. Axial CT measurements of the cross-sectional area of the oropharynx in adults with obstructive sleep apnea syndrome.

AJNR Am J Neuroradiol 17:1107-11, 1996.

[0195] 25. Avrahami E, Englender M. Relation between CT axial cross-sectional area of the oropharynx and obstructive sleep apnea syndrome in adults. AJNR Am J Neuroradiol

16:135-40, 1995.

[0196] 26. Shepard JW Jr, Garrison M, Vas W. Upper airway distensibility and collapsibility in patients with obstructive sleep apnea. Chest 98:84-91, 1990.

[0197] 27. Isono S, Feroah TR, Hajduk EA, Brant R, Whitelaw WA, Remmers JE.

Interaction of cross-sectional area, driving pressure, and airflow of passive velopharynx. J Appl

Physiol 83:851-9, 1997.

[0198] 28. Haponik EF, Smith PL, Bohlman ME, Allen RP, Goldman SM, Bleecker

ER. Computerized tomography in obstructive sleep apnea. Correlation of airway size with physiology during sleep and wakefulness. Am Rev Respir Dis 127:221-6, 1983.

[0199] 29. Caballero P, Alvarez-Sala R, Garcia-Rio F, Prados C, Hernan MA,

Villamor J, Alvarez-Sala JL. CT in the evaluation of the upper airway in healthy subjects and in patients with obstructive sleep apnea syndrome. Chest 113:111-6, 1998.

[0200] 30. Yucel A, UnIu M, Haktanir A, Acar M, Fidan F. Evaluation of the upper airway cross-sectional area changes in different degrees of severity of obstructive sleep apnea syndrome: cephalometric and dynamic CT study. AJNR Am J Neuroradiol 26:2624-9, 2005.

[0201] 31. Vos W, De Backer J, Devolder A, Vanderveken O, Verhulst S, Salgado R,

Germonpre P, Partoens B, Wuyts F, Parizel P, De Backer W. Correlation between severity of sleep apnea and upper airway morphology based on advanced anatomical and functional imaging. J Biomech 40:2207-13, 2007.

[0202] 32. Miki H, Hida W, Kikuchi Y, Takishima T. Effect of sleep position on obstructive sleep apnea. Tohoku J Exp Med 156 Suppl: 143-9, 1988.

[0203] 33. Phillips BA, Okeson J, Paesani D, Gilmore R. Effect of sleep position on sleep apnea and parafunctional activity. Chest 90:424-9, 1986.

[0204] 34. Cartwright RD, Lloyd S, Lilie J, Kravitz H. Sleep position training as treatment for sleep apnea syndrome: a preliminary study. Sleep 8:87-94, 1985.

[0205] 35. Cartwright RD. Effect of sleep position on sleep apnea severity. Sleep

7:110-4, 1984.

[0206] 36. Shepard JW Jr, Thawley SE. Localization of upper airway collapse during sleep in patients with obstructive sleep apnea. Am Rev Respir Dis 141:1350-5, 1990.

[0207] 37. Neill AM, Angus SM, Sajkov D, McEvoy RD. Effects of sleep posture on upper airway stability in patients with obstructive sleep apnea. Am J Respir Crit Care Med

155:199-204, 1997.

[0208] 38. Puhan MA, Suarez A, Lo Cascio C, Zahn A, Heitz M, Braendli O.

Didgeridoo playing as alternative treatment for obstructive sleep apnoea syndrome: randomised controlled trial. BMJ 332:266-70, 2006.

[0209] 39. Sullivan CE, Issa FG, Berthon-Jones M, McCauley VB, Costas LJ. Home treatment of obstructive sleep apnoea with continuous positive airway pressure applied through a nose-mask. Bull Eur Physiopathol Respir 20:49-54, 1984.

[0210] 40. Sullivan CE, Berthon-Jones M, Issa FG. Nocturnal nasal-airway pressure for sleep apnea. N Engl J Med 309:112, 1983.

[0211] 41. Sullivan CE, Berthon-Jones M, Issa FG. Remission of severe obesity- hypoventilation syndrome after short-term treatment during sleep with nasal continuous positive airway pressure. Am Rev Respir Dis 128:177-81, 1983.

[0212] 42. Sullivan CE, Issa FG, Berthon-Jones M, Eves L. Reversal of obstructive sleep apnoea by continuous positive airway pressure applied through the nares. Lancet 1:862-5,

1981.

[0213] 43. Kuhlo W, Doll E, Franck MC. [Successful management of Pickwickian syndrome using long-term tracheostomy]. Dtsch Med Wochenschr 94:1286-90, 1969.

Claims

WE CLAIM:

1. A tracheostomy device comprising: an exo-tracheal flange having a proximal end, a distal end, and a bore extending completely through the flange from the proximal end to the distal end, the flange including a pair of laterally extending wings positioned at the flange distal end; a skin port having a proximal end, a distal end, and a bore extending completely through the skin port from the proximal end to the distal end; and a bridge tube releasably connecting the flange proximal end to the skin port distal end and having a bore fluidly communicating the flange bore with the skin port bore.

2. The tracheostomy device according to Claim 1, further comprising: a plug sized and configured to completely plug the skin port bore.

3. The tracheostomy device according to Claim 1, wherein the bridge tube comprises proximal internal threads and distal internal threads, the skin port includes a distally extending tube having external threads configured to mate with the bridge tube proximal internal threads, and the flange includes a proximally extending tube having external threads configured to mate with the bridge tube distal internal threads.

4. The tracheostomy device according to Claim 1, further comprising: a laterally extending disk having a center hole, the disk positioned between the skin port distal end and the bridge tube proximal end, the disk being laterally bigger than the skin port.

5. The tracheostomy device according to Claim 1, further comprising: a ring positioned around the skin port, the ring having an external surface comprising a material which promotes tissue growth into the ring.

6. The tracheostomy device according to Claim 5, wherein the ring external surface comprises hydroxylapatite.

7. The tracheostomy device according to Claim 1, wherein the exo-tracheal flange comprises a tube extending proximally from the wings, at least a portion of the exo-tracheal bore extending through the exo-tracheal flange tube.

8. The tracheostomy device according to Claim 1, wherein the exo-tracheal flange wings together form a concave distal surface.

9. The tracheostomy device according to Claim 1, wherein the exo-tracheal flange wings each comprise at least one suture hole.

10. The tracheostomy device according to Claim 1, further comprising: a fitting having a laterally extending bore in fluid communication with the bridge tube bore; at least one elongate implantable tube fluidly connecting the fitting bore to the skin port bore.

11. The tracheostomy device according to Claim 10, wherein the skin port is a first skin port, and further comprising a second skin port having a proximal end, a distal end, and a bore extending completely through the skin port from the proximal end to the distal end; and wherein the at least one elongate implantable tube comprises two elongate implantable tubes, each in fluid communication with one of the first and second skin ports.

12. A tracheostomy device comprising: a flange having a bore extending through the flange; and at least one of: an elongate tubular fitting having a proximal end, a distal end, and a lumen extending between the ends, the fitting distal end releasably attached to the flange with the fitting lumen in fluid communication with the flange bore, optionally further including a cover configured and arranged to be received by the fitting proximal end; a cap sized to be received at least partially in the flange bore, the cap including a throughbore; a cap sized to be received at least partially in the flange bore, the cap sealing the flange bore and preventing fluid communication with the environment; a cap sized to be received at least partially in the flange bore, the cap including a throughbore and a proximal skirt having a lateral dimension greater than a lateral dimension of the flange.

13. The tracheostomy device according to Claim 12, further comprising: an exotracheal cuff configured and arranged to be implanted at least partially around a trachea; wherein the flange is attached to the cuff.

14. A method of treating a patient suffering from apnea, the method comprising: implanting a flange adjacent at least partially below the skin of the patient and outside of the trachea of the patient, the flange having a throughbore; and forming a stoma in the patient's trachea immediately adjacent to the flange, such that the stoma is in direct air communication with the environment through the bore of the flange.