Methods and devices for treating sleep apnea and snoring

Methods and devices to prevent and/or treat breathing disorders (e.g., upper airways disorders) in mammals related to impaired airflow are described. Methods and devices apply force to soft tissue that avoids obstruction of airflow in the mammel's airway. Breathing disorders that are avoided by the methods and/or devices include apnea.

FIELD OF THE INVENTION

This invention relates to methods and devices for maintaining upper airway patency.

BACKGROUND OF THE INVENTION

Snoring, upper airway resistance syndrome, and obstructive sleep apnea syndrome (OSAS) are all related to narrowing or obstruction of the upper airway during sleep (sleep disordered breathing). According to the National Institutes of Health (NIH), approximately 18 million Americans have sleep apnea (sleep disordered breathing), but fewer than 50% are presently being diagnosed. According to the National Highway Traffic and Safety Administration (NHTSA), 100,000 accidents and 1,500 traffic fatalities per year are related to drowsy driving. More than 50% of Americans over age 65 have sleep difficulties, and prevalence of sleep problems will therefore increase as the over-65 population increases. Each year, sleep disorders, sleep deprivation, and excessive daytime sleepiness add approximately $16 billion annually to the cost of health care in the U.S., and result in $50 billion annually in lost productivity.

Pathophysiology of Sleep Disorders

Sleep disorders are largely caused by too much soft tissue in the throat. Humans are unique because their upper airway has a curved shape, an anatomical change that is related to the evolution of human speech. As a result the upper airway of humans is more flexible than that of other species and is more prone to collapse under negative pressure. In the awake state a certain amount of tone is present in upper airway muscles to prevent this collapse. However, during sleep muscle tone decreases in upper airway muscles and in certain susceptible individuals this relaxation allows the airway to collapse (Horner R L. Motor control of the pharyngeal musculature and implications for the pathogenesis of obstructive sleep apnea.Sleep1996; 19: 827-853).

The upper airway refers to the air filled spaces between the nose and the larynx (FIG. 1). The most relevant part of the upper airway for sleep disorders is the air cavity at the back of the throat called the pharynx. The pharynx can be divided into three anatomical levels (FIG. 2):

1) The nasopharynx is the part of the pharynx in the back of the nasal cavity.

2) The part at the back of the mouth is called the oropharynx. The oropharynx is the space between the tongue and the pharynx from the edge of the soft palate to the tip of the epiglottis. To be more precise it is best called the velopharynx. This level corresponds to that part of the pharynx containing the velum (soft palate) and tongue curve.

3) The hypopharynyx is behind the tongue base.

The velopharynx is more susceptible to collapse because there are more soft tissue structures, leaving less room for airflow. The major structures of the velopharynx are the soft palate and the tongue, both of which are very flexible. The soft palate acts as a barrier between the mouth and the nose. In many people it is longer than necessary and extends down between the tongue and pharyngeal wall. The tongue is the largest muscular organ of the upper airway and is anatomically divisible into a blade, body and base (FIG. 3). Most of the tongue's curve is at the junction of the tongue body and base.

In the awake condition the structures of the velopharynx maintain their shape because of continuous tone of their internal muscles. When this tone decreases, such as during sleep, these structures become quite flexible and distensible. Without the normal muscle tone that keeps them is place, they tend to collapse at relatively low negative pressures. Although muscles relax throughout the body during sleep many of the respiratory muscle remain active. Specifically, the major muscle that pulls the tongue forward, the genioglossus muscle, has been reported to show normal or increased activity during obstructive apneas. Normally the genioglossus is capable of moving the tongue forward and even projecting it out of the mouth. Why the genioglossus muscle sometimes fails to prevent obstructions has not been explained.

During inspiration the chest wall expands and causes negative pressure to draw air into the nose and mouth and past the pharynx into the lungs. This negative pressure causes upper airway soft tissue to deform, further narrowing the airway. If the airway narrows enough the air flow becomes turbulent causing the soft palate to vibrate. The vibration of the soft palate produces the sound known as snoring. Snoring is extremely common effecting up to 50% of men and 25% of women. By itself snoring is not a medical problem although it can be a tremendous problem for the patient's bed partner and a major cause of marital strain.

A small amount of decreased airflow or brief obstructions occur in all humans during sleep. These episodes are counted as medically significant if airflow is decreased more than 50% of normal for more then 10 seconds (hypopnea) or if airflow is obstructed for more then 10 seconds (apnea). The number of apneas and hypopneas that occur during each hour of sleep is measured to diagnose the severity of the sleep disorder. These episodes of hypopnea or apnea often cause some degree of arousal during sleep. Although the patient does not awaken to full consciousness, the sleep pattern is disturbed causing the patient to feel sleepy during the day. If the frequency of hypopnea or apnea is less than 5 episodes an hour it is called upper airway resistance syndrome. These patients often show symptoms related to the sleep disruption. Specifically, these patients are excessively sleepy during the day. In addition more subtle symptoms such as depression and difficulty in concentrating are also commonly reported. Snoring, hypopnea, and apnea can all be characterized as breathing disorders.

Technically the diagnosis of OSAS is defined as an average of more than 5 episodes of hypopnea or apnea during each hour of sleep. Although the airway is obstructed the patient makes repeated and progressively more forceful attempts at inspiration. These episodes are silent and characterized by movements of the abdomen and chest wall as the patient strains to bring air into the lungs. Episodes of apnea can last a minute or more, and during this time the oxygen levels in the blood decrease. Finally, either the obstruction is overcome, usually producing a loud snore, or the patient awakes with the feeling of choking.

Very common symptoms in OSAS patients are morning headaches and acid reflux. During airway obstructions the forceful attempts to inspire air can cause tremendous negative pressure in the chest. These high negative can draw acid up the esophagus from the stomach. The acid can travel all the way into the mouth and cause inflammation of the vocal cords and nasal mucosa. The presence of the acid in the upper airway causes reflex bronchoconstriction in the lung that is similar to an asthma attack. If even a small amount of acid enters the lung it can cause the vocal folds to close tightly and itself cause a prolonged apnea called laryngospasm. In many patients the repeated stretching of the espophageal sphincter causes chronic changes and these patients can have acid reflux during the day.

Most importantly, sleep disorders can cause serious medical disorders and death. Apneas cause a large strain on the heart and lungs. Over time the many repeated episodes of apnea cause chronic changes leading to hypertension. Long periods of apnea allow the oxygen levels in the blood to decrease. In turn the low oxygen can cause heart attacks or strokes.

Treatment of Sleep Disorders

Although OSAS occurs in both children and adults the cause and treatment is very different. OSAS in children almost always occurs when the child has large tonsils, and tonsillectomy cures the condition. Tonsils naturally decrease in size with age and are rarely a problem in adults. Instead susceptible adults usually have enlargement of their tongues, soft palate and/or pharyngeal walls. This enlargement is mostly due to fat deposits within these structures.

Adult sleep disorders are difficult to treat for a variety of reasons. The upper airway is a very mobile structure that performs the critical functions of swallowing and speech. These functions are easily compromised by surgical procedures or other interventions. In addition, the upper airway also has a large amount of sensory innervation that causes reflex gagging and coughing. Theoretically a physical stent that is placed in the oral cavity and pharynx would be completely effective in relieving sleep apnea. When a patient is totally unconscious, such as when they are anesthetized for surgery, the airway can be stented open by placing a curved oral tube into the mouth and pharynx. In addition, endotracheal tubes establish a secure airway for artificial ventilation. However, after anesthesia wears off, patients immediately sense and react to the foreign objects in their throats and expel them. Therefore devices such as oral and endotracheal tubes, or anything similar, cannot be used for the treatment of OSAS.

Although physical stents cannot be used for OSAS an indirect way of stenting the upper airway with positive air pressure is the most common prescribed treatment for OSAS. This method is called continuous positive airway pressure (CPAP). CPAP requires the use of a mask tightly attached around the nose and connected to a respirator. The exact amount of positive pressure is different for each patient and must be set by overnight testing using multiple pressures. The positive pressure acts like a stent to keep the airway open. CPAP is not a cure but a therapy that must be used every night. Although many OSAS patients are helped by CPAP it is not comfortable for the patient or their bed partner. Patients often cannot tolerate the claustrophobic feeling of a mask tightly attached to their face. In addition they are often many technical problems with maintaining a proper seal of the mask to the face. For these reasons up to half of all patients who are prescribed CPAP stop using it within 6 months (Sanders, “Medical Therapy for Sleep Apnea,” Principles and Practice of Sleep Medicine, 2nd Edition, pp. 678-684)

The only completely effective surgical therapy for OSAS is to bypass the entire upper airway by performing a permanent tracheotomy, a surgical procedure that forms a direct connection to the trachea through the neck. This is a dangerous procedure reserved for the worst cases when there is a high risk of serious medical complications from OSAS. Notably, temporary tracheotomies are often performed on patients with severe OSAS to control the airway before performing before any other procedure is performed on their upper airway. The reason is that these patients are at high risk of acute airway obstruction and death if there is any swelling in their airways. Due to the tremendous excess of swollen tissue in their upper airways OSAS patients are very difficult to intubate under emergency conditions. Similarly there is tremendous amount of fat in the neck that makes emergency tracheotomies extremely hazardous.

Prior to current conservative measures, post operative deaths were not uncommon in severe OSAS patients. Moreover these patients often have acclimated to breathing against resistance, and when the resistance is suddenly removed their respiratory drive decreases. Even today the standard of care in treating most OSAS patients is to have them under close observation in an intensive care unit or recovery room after surgical procedures.

Soft Palate Procedures for Snoring

As the soft palate vibrates more than other tissues it plays a disproportional role in snoring. Various surgical therapies are available that shrink or stiffen the soft palate. The main procedure used is called uvulopalatopharyngoplasty (UPPP). UPPP excises excess soft tissue of the pharyngeal walls and soft palate with a surgical scalpel. Because so much mucosa of the pharyngeal area is traumatized during a UPPP there is a large amount of post operative swelling and severe pain. In selected patients who snore but have no obstructions more limited versions of the UPPP can be done with lasers or electrical cautery.

Newer procedures minimize trauma to the mucosa and use needles to reach the underlying soft tissue to shrink its volume or stiffen it so that it resists vibration. Electrodes can be inserted into the soft palate to deliver radiofrequency energy that shrinks or stiffens the palate (Powell, N B, et al (1998) Radiofrequency volumetric tissue reduction of the palate in subjects with sleep-disordered breathing. Chest 113, 1163-1174.) (Somnoplasty; Somnus; Mountainview, Calif.). Mild caustic agents can be injected that decrease the volume of the soft palate. U.S. Pat. No. 6,439,238 to Benzel teaches the application of a stiffening agent to the surface of the soft palate. Most recently, office based implantation of plastic inserts to stiffen the soft palate has been approved by the FDA (Pillar® Procedure, U.S. Pat. No. 6,546,936: Method and apparatus to treat conditions of the naso-pharyngeal area).

The fundamental shortcoming of all procedures that target the soft palate, including the newer techniques, is that they only partially improve OSAS (Loube D I (1999) Technologic Advances in the Treatment of Obstructive Sleep Apnea Syndrome. Chest. 1999; 116:1426-1433, Doghramji, K, et al (1995) Predictors of outcome for uvulopalatopharyngoplasty. Laryngoscope 105, 311-314). Although studies report a decrease in the number of apneas, these patients are rarely cured. Evidently the critical structure causing OSAS is not the soft palate but the tongue.

Tongue Base Procedures For OSAS

The methods used to treat the tongue base in OSAS are either to permanently decrease its volume, to decrease its flexibility or to move the entire tongue forward. Surgical excision of the tongue base has been poorly effective. The results for scalpel or laser resection of the tongue base in OSAS treatment have not been good enough to recommend continued application of these procedures (Mickelson, S A, Rosenthal, L (1997). Midline glossectomy and epiglottidectomy for obstructive sleep apnea syndrome. Laryngoscope 107, 614-619).

More recently radiofrequency (U.S. Pat. No. 5,843,021 to Edwards) and ultrasonic (U.S. Pat. No. 6,409,720) energy have been proposed to shrink and stiffen the tongue base with radiofrequency energy. The radiofrequency energy is delivered via needle electrodes that are inserted into the tongue base to cause a lesion that scars and shrinks over time. To avoid postoperative swelling and pain a limited amount of lesioning is done in a single session and patients require an average of 5 treatments. About a third of patients have greater than 50% improvement in their OSAS. However, approximately a fourth of patients have significant post operative complications, including, tongue base ulceration and abscesses, and temporary tracheotomy.

A recent introduced device for tongue base advancement is the Repose® system (Influent Corp; San Francisco, Calif.). The procedure is performed under general anesthesia, and the Repose® system includes insertion of a screw at the base of the mandible. The screw contains attachments for a permanent suture that is tunneled under the mucosa of the floor of the mouth to the back of the tongue, then passed across the width of the tongue base, and brought back to attach to a metal hook screwed into the bone of the mandible. The suture is tightened to displace the tongue base forward, and caution must be observed to prevent excess tension leading to necrosis of tissue. Unfortunately studies of the Repose® procedure show that it is ineffective at eliminating OSAS. Only 1 of 15 patients was cured of OSAS while 2 patients had to have the suture removed due to pain and swelling.

More aggressive surgical procedures require reconstruction of the mandible, facial, skeleton or the hyoid bone. An example of the art is U.S. Pat. No. 6,161,541 to Woodson that teaches a method of surgically expanding the pharyngeal airway. These procedures require extensive surgery with higher risks and much longer recovery periods.

Other proposed methods for treating the tongue base include stiffening the soft tissue by injection of sclerosing particles U.S. Pat. No. 6,742,524 or other implanted material US Patent Application Publication No. 20050004417A1.

Various neuroprosthetic devices have been invented that stimulate upper airway muscles. U.S. Pat. No. 4,907,602 to Sanders describes transmucosal stimulation to dilate the airway; U.S. Pat. No. 5,792,067 to Karell teaches an intraoral device that applies electrical stimulation to the hard palate, soft palate or pharyngeal area to induce contraction of the upper airway muscles; U.S. Pat. No. 5,190,053 to Meer teaches an intraoral device that applies electrical stimulation to the genioglossus muscle via electrodes located on the mucosa on the floor of the mouth on either side of the frenulum. In addition U.S. Pat. No. 5,591,216 to Testerman describes a totally implantable device to stimulate the nerves to the genioglossus muscles. In addition, WIPO Patent Application No. 04064729 to Gordon describes a neuroprosthetic device that can be injected into the soft palate to treat snoring. At present these devices have not been clinically proven. In summary, sleep disorders are a significant health problem without an acceptable solution and there is a need in the art for new and more effective therapies.

SUMMARY OF THE INVENTION

While not wishing to be bound by any single theory my studies of human tongue anatomy suggest that episodes of obstruction evolve by a sequence of events (FIGS. 4A-4F). The initial inciting event is the deformation of a relatively small part of the tongue451. Under certain conditions deformation begins in soft tissue on the top of the tongue451, particularly in the area of the tongue curve, and specifically near the center line of the tongue curve. As this tissue deforms it narrows the airway and causes more negative pressure thereby causing greater deformation. This feedback cycle in turn deforms enough tissue in the area to cause a complete obstruction in the velopharyngeal area.

If an initial obstruction occurs near the end of inspiration, the obstruction is relieved by an expiration, or by action of the genioglossus muscle. However, if the obstruction occurs at the beginning of inspiration reflexes trigger stronger inspiratory effort that further lowers airway pressure. This increased negative pressure causes deformation and collapse of most of the tongue base453. At this point the airway is firmly plugged by soft issue and activity of the genioglossus only stretches the tongue tissue that is plugged and cannot dislodge it.

Therefore the tongue curve is the critical area that initiates the cascade leading to obstruction. This relaxed muscle is very flexible and easy to deform, however, the converse is also true, very little force is needed to prevent this deformation. Therefore if sufficient counterforce is exerted at the proper localized area of the tongue451it can prevent obstruction without noticeable effects on speech and swallowing movements.

How a device could prevent the deformation and collapse of the tongue curve is not a trivial problem:This area of the tongue is very mobile during speech and swallowing, therefore the amount of force exerted must be low and highly localized. It is unacceptable to render the area immobile, as would be done if were stiffened by a large implant or scar tissue.The whole area of the velopharynx has extensive sensory innervation, and relatively minor stimulation there causes either a gag or a swallow.The tongue base and body have a larger blood supply than comparable muscles elsewhere in the body. Any implant placed in the area has a high probability of causing internal bleeding with potentially catastrophic tongue swelling.Soft tissue and tongue in particular remodel easily. Specifically sutures or implants that exert force cause the tissue to remodel to relieve that force. This is known as the “cheese cutter” effect. Therefore, the forces applied to the soft tissue and/or tongue must be relatively low and applied for limited periods.Humans upper airway anatomy is highly variable, and the pathological anatomy of sleep apnea patients is even more variable. Moreover the upper airway anatomy of sleep apnea patients changes over time as the disease progresses or improves.Finally, OSAS patients have borderline airways that can obstruct after even minor amounts of swelling such as that following surgical manipulation. Therefore it not obvious how a device could both exert force in the area yet avoid swelling.

Moreover to be maximally effective and to get patient and physician acceptance the device would ideally require additional qualities:It should be capable of being inserted as an outpatient procedure.Preferably the device could be removed during the day and reinserted by the patient at night.It would be adjustable to conform to the specific needs of the patient.It would be comfortable for the patient.When the device was in place it would not be noticeable to anyone else.

There is a tremendous variability in human upper airway anatomy, and even further variation in the pathological changes contributing to sleep apnea and related disorders. Moreover, the pathological anatomy changes over time in each patient as their condition improves or deteriorates. No single method and device is able to treat all contingencies. Therefore there is a critical need for methods and devices that are optimized for different sites in the upper airway.

Embodiments of the invention include methods and devices to prevent or treat upper airway breathing disorders related to impaired airflow in mammals. These breathing disorders are, without limitation, snoring, upper airway resistance syndrome, and obstructive sleep apnea. In addition, this invention is applicable to airway disorders in animals including but not limited to dorsal displacement of the soft palate in horses and brachycephlic obstructive airway syndrome in certain breeds of dog. Those skilled in the art will readily appreciate that application of this invention can be applied to other conditions of the upper airway.

One aspect of the invention prevents airway obstruction by dilating the airway or preventing the tissue from deforming. It enlarges the airway when excess tissue is present and also counteracts the deforming influence of negative airway pressure on the relaxed soft tissue of upper airway structures. These structures include, without limitation, the tongue, soft palate, pharyngeal walls and supraglottic larynx.

FIGS. 5A-5D, depict one embodiment of a device referred to as a tissue retractor or as a Linguaflex tongue retractor (LTR) (notwithstanding that the use of the device as disclosed herein the tissue retractor or LTR device is not limited to use in the tongue or to use for tissue or tongue retraction). The LTR includes a retractor member (R), a shaft (S), and an anchor member (A). In some embodiments a retractor member (R) is physically coupled to the soft tissue of the tongue base. The shaft (S) passes through the midline of the tongue to connect with an anchor member (A). The anchor member (A) imparts counterforce through the shaft (S) to the retractor member (R), thereby preventing deformation of the soft tissue.

One aspect of this invention describes improvements to the retractor member, shaft and anchor member that increase the efficacy of the device while decreasing patient discomfort. Improvements of the tissue retraction (e.g., the LTR) components include but are not limited to a retractor member with a retractor head that collapses to fit within a narrow delivery device and expands after insertion; a shaft that passively adjusts its length and tension in response to surrounding tongue activity; and a modified anchor that is adjustable by the patient and attaches to a bolster (e.g., a soft bolster), a partially implanted receptacle in the mouth, and/or a dental appliance.

One aspect of the invention is a method of making the implant more comfortable by allowing the device to be under little or no tension during the day, in the “unloaded” state, and to increase the tension to therapeutic levels at night, in the “loaded” state. This loading and unloading method increases the comfort for the patient and allows the patient a large degree of control. The method and the devices that implement the method are of great importance, because the lack of patient compliance is perhaps the largest problem with current sleep apnea therapies. A method and/or device that is comfortable to the patient has an increased likelihood of patient compliance.

Another aspect of this invention is that additional sites in and around the tongue can unexpectedly be treated to prevent airway disorders. Non-limiting examples of these sites are the base of tongue, the mucosa covering the tongue, the tongue frenulum, the pharyngoglossal fold, the palatoglossal fold, the aryepiglottic fold, the lateral pharyngeal wall, and the soft palate. An improved tissue retractor (e.g., an LTR) applied to one or more of these sites directly or indirectly stiffens and displaces tissue and/or mucosa in, for example, the tongue base, the soft palate, and the lateral pharyngeal wall, and enlarges the velopharynx thereby avoiding obstruction of the patient's airway. Each site has specific anatomy and suitable tissue retractors are disclosed for use in various anatomical areas to perform efficiently and with minimal risk and discomfort to the patient.

One aspect of this invention is a tissue retractor (e.g., an LTR) that indirectly retracts tongue base via its implant site in the frenulum area. Placement in the frenulum area simplifies the insertion, adjustment, and maintenance of the device. Another aspect of this invention describes a highly localized and fully implantable tissue retractor (e.g., LTR) that is inserted into the base of tongue to stiffen lax surface mucosa or mechanically couple it to internal tongue structures.

Another aspect of this invention is a tissue retractor (e.g., an LTR) inserted in or around the pharyngoglossal fold. This site allows retraction and stiffening of tongue base tissue as well as the soft palate and lateral pharyngeal wall. The advantage of the pharyngoglossal fold site is its minimal invasiveness, safety and its beneficial effect on multiple different structures.

Another aspect of this invention is a method and device to remodel upper airway tissue in order to enlarge the pharyngeal airspace. Tissues remodeled include but are not limited to tongue base, palatine tonsil, pharyngeal wall, and soft palate. Preferably these tissues are either compressed to decrease their volume, displaced to provide space in other areas, or reshaped. In some embodiments, the tissue remodel effect lasts from months to years after the device(s) have been removed. To achieve this persistent beneficial effect, devices would preferably exert force on the tissue for a time that ranges from about 1 week to about 1 year or from about 1 month to about 6 months.

Another aspect of this invention includes non-invasive methods and devices that reversibly couple to mucosa to grasp, move and/or reposition soft tissue. Suitable non-invasive methods use magnets, adhesives, vacuum, and/or mechanical leverage. In one embodiment a curved retractor member is reversibly inserted into one or more selected sites. In another embodiment indwelling clamps are placed on one or more of the PGF, tonsillar folds, the soft palate and other soft tissue folds. A suitable retractor member can be loaded as needed by coupling the retractor member to a modified anchor inside or outside of the patient's mouth. In still another embodiment, the floor of mouth is protracted to displace the tongue base. In a still further embodiment a vacuum reshapes the tongue to decrease the volume of the tongue in the tongue base. Another aspect of this invention describes tissue retractors (e.g., LTR's) specifically adapted to prevent dorsal displacement of the soft palate in horses.

The tissue retractor (e.g., the LTR) can pass through tissue and have its retractor member and anchor member ends outside of tissue, have only one end outside of tissue and exposed, or the entire device can be implanted. The shaft of the device can pass deeply into tissue, or pass superficially just beneath the mucosa. The retractor member and the anchor member are preferably shaped to fit in a site so as to distribute force evenly. For example, all or a portion of the tissue retractor has a flat shape for placement in flat or mildy curved surfaces such as the mid tongue base, pharyngeal wall, and soft palate. All or a portion of the tissue retractor is wedge shaped for placement at or near the depths of the pharyngoglossal fold and lateral margin of the soft palate. All or a portion of the tissue retractor (e.g., the anchor member) is V shaped for placement at or near the frenulum. All or a portion of the anchor member is T shaped for placement at, near, or through the teeth. The materials used to form the tissue retractor, the implant, the retractor member and/or the anchor member can include any non-reactive biocompatible materials. Suitable non-reactive biocompatible materials are known in the art. Non-limiting examples of suitable rigid materials include stainless steel, titanium, ceramics, and plastics. Non-limiting examples of suitable elastomeric materials include silicon and rubber.

In some embodiments, the force needed to displace the tongue anteriorly or the soft palate superiorly varies from about 0.001 gram to about 10,000 grams, about 0.1 gram to about 1000 grams, or about 10 to about 100 grams. This force could be applied over a time that ranges from about 0.01 seconds to permanently, about one minute to about 1 month, for the duration of sleep, or during episodes of restricted upper airway flow.

It is to be understood that the attached drawings are for purposes of illustrating the concepts of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1. Drawing of the human upper airway in the mid sagittal plane.

FIG. 2. Simplified schematic drawing of the areas of the pharynx, the tongue and surrounding structuresNP, NasopharynxVP, VelopharynxHP, HypopharynxSP, Soft palateP, Hard palateT, TongueGG, Genioglossus muscle

FIG. 3. Anatomical landmarks of the tongue. The tongue will be defined as the grey area of this schematic. From front to back the tongue is divided into a blade, body, and base. The genioglossus muscle (GG) inserts into a connective tissue boundary on the undersurface of the tongue (Bo). The entire region of the genioglossus muscle and its mucosa is referred to as the “frenulum area”.BA) Tongue baseBD) Tongue bodyBL) Tongue bladeBo) Boundary between tongue and genioglossusC) Tongue curveF) FrenulumGG) Genioglossus muscle

FIG. 4. Mechanism of airway obstruction and the effect of current therapies.

4A. Shows the normal tone in a tongue451while a patient is awake. The tongue451remains in position allowing the airway to remain open. The arrow469shows airflow through the airway, the small arrow412shows the relationship of pharyngeal wall465to the mandible468.

4B. During sleep muscle tone is lost in the tongue451and the tongue451becomes flaccid. Negative pressure in the pharynx during inspiration causes backward collapse of the tongue451in the velopharyngeal area, because the airway is narrowest at that point and the tongue curve (circle) is most deformable.

4C. After the airway obstructs airflow469at the velopharyngeal area inspiration lowers the pressure in the pharynx further causing the base453of tongue451to deform and firmly block the airway.

4D. CPAP works by pumping air416at high pressure through the patient's nose, thereby splinting the pharynx open.

4E. Dental devices work by moving the entire jaw forward. Depicted is the impact of the dental device on the patient's mouth, but not the dental device itself. As the tongue451is attached to the soft tissues along the floor of the mouth, and they attach to the jaw, the tongue451is indirectly moved to expand the airway. Note that the jaw has moved in relation to the pharyngeal wall465.

4F. The tissue retractor401(e.g., an LTR) prevents posterior deformation of tongue451curve by directly restraining the tongue451curve from moving backwards.

FIG. 5. Embodiment of the tissue retractor (e.g., an LTR) device. Shown is one embodiment of the LTR.

5A. The LTR has three main components: a retractor member (R), a shaft (S), and an anchor member (A).

5B. Side view of the tissue retractor (e.g., an LTR) inserted in a tongue.

5C. Back view of tongue curve showing retractor position.

5D. Back view of tongue base showing the curved midline shape taken from the posterior aspect of the tongue.

FIG. 6A-6E. Retractor member. This figure illustrates a retractor component of a tissue retractor601(e.g., an LTR) that can be mounted on a needle635for implantation within upper airway tissue650and deploys when the needle635is withdrawn. The retractor member620is shown as an integral component of the shaft610and is molded as one piece from soft elastomeric material.

6A. Four views, two side views and two front views of the retractor member620head. The plane of the retractor member620head rests at about 15° relative to the shaft610.

6B. Side view of retractor member620head mounted within a needle635. A part of the retractor member620head lays on the outer surface of the needle635.

6C. Side view of needle635passing through tissue650. Note that the retractor member620head lays flat against the needle635barrel and does not interfere with passage of the needle635through tissue650.

6D. After the needle635penetrates mucosa enough to clear the tissue650the retractor member620head again extends away from the shaft610such that the retractor member620head rests at about 15° relative to the shaft610.

6E. Slight traction on the shaft610causes the retractor head620to catch the mucosa and/or tissue650and come to rest in its working position.

FIG. 7. Shaft member710. Shown is an improvement to the shaft of a tissue retractor701(e.g., an LTR) that maintains its retractor tension when the tongue751is relaxed, such as during sleep. However, during speech and swallowing, when the tongue base often moves backward, the activity of the tongue751squeezes the shaft710and thereby lengthens it. In this way there is little or no resistance to the normal tongue751movements.

7A. Schematic view of LTR in the tongue751with normal muscle tone. Note that the retractor member720head lays on the mucosal surface of the tongue base without indenting it.

7B. During sleep the tongue751loses all tone and tends to flop backward into the airway. The retractor member720head then resists this deformation.

7C. During swallowing and speech the tongue base sometimes moves backward. During these movements there is a strong contraction of the tongue muscles. This contraction squeezes the upper shaft711, this in turn causes the shaft710to lengthen and move the tissue retractor701.

8E. The anchor member830and the shaft810are pulled forward and a portion of the shaft810is slotted into the cleft848on underside of the bolster840.

8G. Close up view of tissue retractor (e.g., LTR) anchor member830sitting in the recess (i.e., the cleft848) of the bolster842.

8H. Top view of tongue851with a tissue retractor801(e.g., LTR) retractor member820and a bolster.

9A. Shows a modified anchor that is reversibly attached to the upper or lower front teeth. The anchor member930(A) interfaces with the teeth, the shaft910(S) connects to retractor/coupler920(R/C). The retractor/coupler either has a retractor member920that interfaces with tissue, or a coupler component that connects to an implanted retractor, shaft, or anchor member of an implanted tissue retractor (e.g., an LTR).

9AA. Shows a side view of the anchor member930(A) the anchor member930has depth that is wide, the shaft910and the retractor member920are also depicted.

9B. Drawing of top view of tongue951and mandible968with a tissue retractor901(e.g., an LTR) implanted from the tongue base953to the frenulum. The anchor930of the LTR can be reversibly attached to the R/C component920of the dental anchor.

9C. Another embodiment of a tissue retractor901having a modified anchor member930for use on the lateral teeth998.

9D. Top view of tongue951and mandible968with a lateral dental anchor member930. The anchor member930attaches to the molar tooth998, the shaft910passes through or over the pharyngoglossal fold967, and the retractor rests920against the posterior surface of the fold.

9E. A palatal prosthesis972provides an anchor member930with some possible coupling extensions for retraction or protraction of surrounding structures including the soft palate966, the PGF967, the floor of mouth976, and the tongue951surface (couples at the tongue surface at, for example, a tongue stud.

Within the genioglossus muscle1063are small tendons upon which muscle fibers insert at various angles. The main tendon is in the middle of the muscle and smaller tendons branch off at various points. Preferably an anchor1031is inserted in the frenulum area1060such that the implanted portion of the anchor1031passes through a tendon. However, the anchor1031can be inserted into any spot in the frenulum area1060or inserted into soft tissue attached to the mandible1068. The anchor1031could be coupled to a tissue retractor (e.g., an LTR) by a variety of mechanisms as described herein.

10A. Photograph of the side view of the tongue1051and mandible1068cut in the centerline (mid-sagittal plane).

10B. Drawing of the photograph of the side view of the tongue1051depicted inFIG. 10A.

10C. Close up of the frenulum area1060an anchor1031is inserted into the frenulum1060.

11A. Photograph of the side view of the tongue1151and mandible1168cut at the centerline. The frenulum1160is the front edge of the genioglossus muscle1163, frenulum area1160refers to the entire genioglossus1163and surrounding mucosa. The front and rear boundaries of the genioglossus muscle1163are marked by solid lines. The genioglossus muscle1163attaches to a small area on the inner surface of the mandible1168and tendinous extensions from that area. It fans out from these attachments to insert mostly into connective tissue along the length of the body and base of the tongue1151called the boundary layer1161.

11B. Drawing of the photograph of the side view of the tongue1151depicted inFIG. 11A.

11C. Shown is a tissue retractor1101(i.e., an LTR) passing through the frenulum area1160and anchored externally to a dental anchor. The dental anchor can be, for example, a tooth (located in the region of the mandible1168) over which the tissue retractor1101is looped. The implanted part of the LTR1101exerts anterior forces on the genioglossus1163muscle fascicles1164and this is conveyed to the boundary layer1161and finally to the tongue1151base (arrow/1153). The arrow1153shows the direction of force and the displacement from the tongue base to the boundary by the retractor pulling the frenulum area1160anteriorly.

11D. Shown is an LTR1101passing through the boundary layer1161and anchored to a modified anchor1131(e.g., a frenulum anchor). Displacement of the tongue1151is marked by the arrow.

11E. Shown is a fully implanted LTR1101in the frenulum area1160connecting the boundary area1161in two places. Note that the beneficial retraction of the tongue base1153causes some retraction of the tongue blade1152, however, this retraction of the tongue blade1152does not interfere with tongue1151function.

12A. Photograph of a frontal section of tongue1251base.

12B. Drawing of12A. Light lines are the connective tissue of the tongue superior layer (SL)1258and the midline septum (MS)1255. The middle layer (ML)1254is the volume of the tongue1251beneath the (SL)1258.

12D. Photograph of the tongue1251seen in mid-sagittal plane. Oval marks the area of mechanical decoupling.

12E. Schematic drawing of the portion of the tongue1251in the box marked in the photograph shown inFIG. 12D.

12F. Position of tissue retractor1201implant.

13A. Lateral (left) and top (right) drawings of the tongue1351with a tissue retractor1301(e.g., an LTR) in which a retractor member1320and an anchor member1330are connected by a shaft1310passing underneath the tongue base mucosa. Shown are an anchor member1330, a retractor member1320, and a shaft1310that connects the anchor member1330and the retractor member1320. The shaft1310is shown as a dotted line when implanted in the soft tissue1350, e.g., the tongue1351. The shaft1310is shown as a solid line when it is outside soft tissue1350(see,FIG. 13D, for example). The arrow1313shows the direction of retraction when the retractor member1320, the shaft1310, and the anchor member1330interact to exert a pressure on at least a portion of the soft tissue1350.

13B. Lateral (left) and top (right) drawings of the tongue1351with a tissue retractor1301(e.g., an LTR) with the shaft1310taking a more direct route through the tongue1351between a retractor member1320and an anchor member1330.

13C. Lateral (left) and top (right) drawings of the tongue1351with a tissue retractor1301(e.g., an LTR) with the shaft1310exiting from mucosa close to the retractor member1320and connected to the anchor member1330. Portions of the shaft1310closes to the retractor member1320and the anchor member1330are beneath the mucosa and other portions of the shaft1310are exterior to the tongue1351.

13D. Lateral (left) and top (right) drawings of the tongue1351with a tissue retractor1301having an implanted anchor member1330, an implanted retractor member1320and a reversible attachable shaft1310.

13E. A lateral view of a partially implantable retractor member1320, which has a first portion1321implanted in soft tissue1350and a second portion1322external to the soft tissue1350. An anchor member1330could likewise be partially implantable.

13F. A top view of a partially implantable retractor member1320.

13G. A lateral view of a partially implantable retractor member1320showing the shaft1310connecting to the second portion1322of the retractor member1320, and the second portion1322is exterior to the soft tissue1350.

13H. A lateral view of a partially implantable retractor member1320with the second portion1322extension depressed such that the second portion1322is substantially flush with soft tissue1350mucosa when the retractor member1320is not in use.

13I. Lateral (left) and top (right) drawings of tongue1351with a tissue retractor1301(e.g., an LTR) with an elastic sleeve or a band1370placed over the tongue blade and a shaft1310connecting to a partially implanted retractor member1320. The arrow1313shows the direction of force and tongue base displacement.

13J. Lateral (left) and top (right) drawings of a tongue1351with a tissue retractor1301(e.g., an LTR) anchored by an anchor member1330in each PGF1357and a shaft1310passing across the tongue1351base and contacting at portion of a partially implanted retractor member1320.

13K. Lateral (left) and top (right) drawings of a tongue1351with a first tissue retractor1301a(e.g., an LTR) anchored beneath the tongue blade1352by a first anchor member1330a, a first shaft1310apasses through the tongue blade to a first retractor member1320a. The first retractor member1320aacts as a modified anchor member, which is the second anchor member1330bon the superior surface of the tongue1351. A second shaft1310bpasses posteriorly to a semi implanted second retractor member1320b. At portion of the semi implanted second retractor member1320bis implanted in the tongue1351. The use of a first tissue retractor1301aallows adjustment of tension of the second tissue retractor1301bfrom the anchor site of the anchor member1330alocated beneath the tongue blade1352.

13L. Lateral drawing of a tongue1351with a tissue retractor1301includes a rigid shaft1310that connects an anchor member1330below the tongue blade1352to a retractor member1320above the tongue blade1352.

13M. Lateral drawing of a tongue with a sleeve (e.g., a band1370) reversibly placed over the tongue blade1352and the tissue retractor1301shown inFIG. 13Lis rotated forward by the band1370. The band1370pushes and rotates the retractor member1320forward and pushes the anchor member1330forward. The counterforce that allows pushing of the tissue retractor1301comes from resistance of the tongue1351being compressed by the band1370.

14A. Side view of the upper airway showing the area of the tongue where the PGF inserts. A smaller superior region is of particular significance as it receives overlapping insertions of muscles connecting to the soft palate and lateral pharyngeal walls, including but not limited to the palatoglossus and superior pharyngeal constrictor muscles.

14B. Side view of tongue in relation to mandible with the area of superior PGF attachment marked.

14C. The palatoglossus muscle is shown connecting the soft palate to the superior PGF.

14D. The superior pharyngeal constrictor muscle connects the pharyngeal walls to the superior PGF.

14E. Schematic showing that retraction force of the PGF is dispersed to the tongue base, soft palate, and lateral pharyngeal walls.

15A. Drawing showing the posterior collapse of the tongue1551and its effects on airflow1569through the airway.

15B. A retractor member1520at the PGF1557(i.e., the first PGF) and a shaft1510that passes across the frenulum1560to a retractor in the other PGF (i.e., the second PGF). The shaft1510can pass anteriorly to a dental anchor or other anchor in the patient's oral cavity.

15C. A retractor member1520in the PGF1557and a shaft1510passing through the tongue1551tissue to emerge and connect to a modified anchor1531. An alternative embodiment shows the retractor member1520in the PGF1557passes through the tongue1551tissue through the floor of the mouth1576to an external anchor1532resting on the skin1590.

15D. An implanted tissue retractor1501(e.g., an LTR) with a retractor member1520in or near the PGF1557and a shaft1510passing through tongue1551to an anchor member implanted in the genioglossus muscle or an anchor member implanted in structures located in or at the floor of the mouth1576.

15E. A tissue retractor1501(e.g., an LTR) with a retractor member1520in the superior PGF1557aand an anchor member1530in the inferior PGF1557b. Arrow1513shows the inferior displacement of the tongue base1553.

15F. A retractor member1520in the PGF1557and a shaft1510passing through the tongue1551to an anchor member1530on the superior surface of the tongue1551.

16A. A retractor member1620at the tongue base1653is connected by two sub-mucosal shafts1610to anchor members1630disposed in front of each PGF1657.

16B. A sub-mucosal shaft1610connects two anchor members1630each anchor member1630is in front of each PGF1657.

16C. Two implanted anchor members1630are in or near the PGFs1657and the first anchor member1630is connected to the second anchor member1630by a sub-mucosal shaft1610.

16D. Magnets1691implanted in or near each PGF1657are connected by a sub-mucosal shaft1610. The tissue retractor is “loaded” by exposing the implanted magnets1691to an external magnet that is attracted to the magnets1691.

16E. Two figures on the left show a magnet1691implanted in a PGF1657is retracted by a magnet of opposite polarity attached to a modified anchor. Two figures on the right show a magnet1691enclosed in an implant that has two flanges to keep the implant in place within the PGF1657.

16F. Left, a schematic of a tissue retractor1601that has an anchor member1630that can be a dental type modified anchor. The anchor member1630is a clasp that reversibly attaches to teeth1698as shown on right. A shaft1610of variable length attaches to a retractor member1620or to a coupling mechanism that in turn connects to an implanted retractor member. The implanted retractor member may be a magnet or mechanical mechanism. Right, Drawing of tongue1651and mandible1668seen from above. Two embodiments of the dental modified anchor are shown: in the bottom embodiment, the retractor member is a magnet that couples to an implanted magnet as shown in the two figures on the left ofFIG. 16E; in the top embodiment, the shaft ends with a magnet that couples to a reversible magnetic implant as shown in the two figures on the right ofFIG. 16E

17A. View of the mouth showing the soft palate and palatoglossal folds (Henry Gray. Anatomy of the Human Body. 1918).

17B. Same view asFIG. 17Abut with mucosa removed showing the underlying muscles (right side) and the nerve and blood supply (left side).

17C. View of the left lateral pharyngeal wall area after mid-sagittal section ofFIG. 17B. The tongue is retracted inferiorly.

Four positions for placement of tissue retractors are shown, in each of the four positions an anchor member1730is positioned in the superior PGF:

Position 1) the shaft passes next to palatoglossus muscle around the tonsil, the retractor rest against lateral edge of soft palate. This embodiment increases the lateral velopharyngeal area.

Position 2) the shaft travels within the palatoglossus muscle, the retractor is near the midline soft palate. This embodiment increases medial velopharyngeal airspace.

Position 3) the shaft passes through the palatoglossus muscle, the palatine tonsil, and the palatopharyngeus muscle, the retractor rests against the posterior wall of the soft palate. This embodiment compresses and permanently remodels the palatine tonsil.

Position 4) the shaft passes 1 cm under the tongue base mucosa and the retractor rests against tongue base. This position of tissue retractor placement can be employed for tensing the tongue base.

18A. The tissue retractor1801has a retractor member1820on the posterior surface of posterior tonsillar fold, at least a portion of the shaft1810is inside the tissue of the soft palate, the anchor member1830is on the anterior surface of anterior tonsillar fold. This is employed for compression of the palatine tonsil.

18B. A retractor member1820in the superior Palatoglossus fold and an anchor member1830in the inferior Palatoglossus Fold or PGF.

18C. The tissue retractor1801is implanted within the palatoglossus muscle.

18D. The anchor member1830at lateral aspect of soft palate, at least a portion of the shaft1810is inside the tissue of the soft palate, the retractor member1820midline of the soft palate.

18E. The tissue retractor1801retractor member1820is on the inner surface of the palatoglossal fold and the anchor member1830is a modified dental anchor that couples to a patient's tooth1898.

18F. The tissue retractor1801retractor member1820is posterior the tonsillar fold, at least a portion of the shaft1810is inside the tissue of the soft palate, and the anchor member1830is anterior the tonsillar fold.

19A. Top (left) and lateral (right) drawings of the soft palate the anchor member1930is in the superior pharyngeal side19661and the retractor member1920is in the inferior oral side19662.

19B. Top (left) and lateral (right) drawings of the soft palate the retractor member1920is in the superior oral side19662and the anchor member1930is in the inferior pharyngeal side19661.

19C. Top (left) and lateral (right) drawings of the soft palate. A bolster1940is added in front of the anchor member1930to load the tissue retractor1901. Note the indentation and rotation of the soft palate1966.

19D. Top (left) and lateral (right) drawings of the soft palate. A tissue retractor1901is totally implanted in the soft palate1966.

19E. Top (left) and lateral (right) drawings of the soft palate. A retractor member1920and an opposing anchor member1930are disposed through the soft palate1966.

19F. Top (left) and lateral (right) drawings of the soft palate. The tissue retractor1901provides an attachment for retainers (e.g., one or more bands1970) that lift edge of soft palate1966.

FIG. 20. Veterinarian embodiments—Shown are embodiments of this invention for equine dorsal displacement of the soft palate2066.

20A. Normal configuration of the horse upper airway during exercise. Note that the soft palate2066overlaps and interlocks the epiglottis2063of the larynx to provide an open conduit for airflow2069.

20B. In dorsal displacement of the soft palate (DDSP) in horses the soft palate2066is dislodged from its locked position and obstructs the airway from airflow2069. This is believed to be caused by the backward movement of the tongue base2053.

20C. An embodiment of a tissue retractor2001(i.e., an LTR) for this condition. The shaft2010reaches through the mandible2068to an adjustable anchor member2030in front of the mandible2068.

20D. Another embodiment where the shaft2010connects to an anchor member2030on the tongue2051surface which is reversibly attached to the bit2067of a bridle during exercise.

20E. An embodiment that employs a tissue retractor2001to directly oppose dislodging the soft palate2066from its normal position. An anchor member2030in front of the soft palate2066passes backward and then through the epiglottis2063to a retractor member2020on the laryngeal surface of the epiglottis2063.

20F. Another view of the of the soft palate2066and epiglottis2063employing the tissue retractor2001depicted inFIG. 20E.

20G. In an alternative embodiment a tissue retractor2001b,2001c(e.g., an LTR) passes from the PGF's2057to the lateral aspect of the soft palate2066. The view is from the front and the tongue2051is transparent. For comparison, the midline embodiment described inFIG. 20Eis also shown with the anchor member2030of the tissue retractor2001ain the soft palate2066.

21A. Schematic of airway obstruction to airflow2169due to backward collapse of the tongue2151.

21B. PGF2157retraction employs a soft “hook” that retracts the PGF2157forward and thereby retracts the base2153of the tongue2151, the soft palate2166and the pharyngeal walls2165.

21C. Close up view of a portion of a “hook” shaped retractor member2120.

21D. Close up view of a clamp2193that remains in place surrounding the PGF2157by compressing the soft tissue of the PGF2157with its arms. The clamp2193would always be available for hooking up with, for example, a shaft and because it stays in position it would avoid causing the gag reflex each time it is placed.

21E. An embodiment of a clamp2193surrounding the PGF2157where compression is performed by two magnets2191,2192of opposing polarity.

21F. Embodiment from21E where the clamp's2193magnets2191,2192are also used to couple to a shaft2110A where the clamp2193acts as a retractor member2030that is attached by the shaft2110A to a modified anchor.

21G. Drawing of two tissue retractors2101reversibly placed in a patient's mouth and the effect of the two tissue retractors2101on the tongue base2153(dotted line).

21H. Close-up view of a tissue retractor2101having a hook shaped anchor member2130.

22A. Side view of clamp2293on soft tissue fold. One method of reversibly attaching to the fold is to compress the tissue by the ends of the clamp2293.

22B. Side view of a clamp2293having magnets2291,2292of opposite polarity. The magnets attraction provides sufficient force for a stable clamp2293position and a shaft is unnecessary to maintain the clamp2293in position on the mucosal fold2259.

22C. Front view of clamp2293on a soft tissue fold. The shaft2210connection between the arms of the clamp2293can serve to retract the edge of the mucosal fold2259.

22D. Two clamps2293A,2293B are used to provide protraction (lengthening) of tissue, protraction can have a useful effect on structures that benefit from stiffening such as the soft palate and the tongue base.

22E. A clamp2293on anterior tonsillar pillar attached via a shaft2210to a dental anchor2230that is reversibly anchored to a tooth2298.

22F. A clamp2293on posterior tonsillar pillar attached via a shaft2210to a dental anchor2230that is reversibly anchored to a tooth2298.

22G. A clamp2293on the edge of soft palate attached via a shaft2210to a dental anchor2230that is reversibly anchored to a tooth2298.

22H. Two clamps2293A,2293B attached by a shaft2210C that retract the pharyngeal wall toward the aryepiglottic fold, thus stiffening the lateral pharyngeal wall.

23A. Side view. Floor of mouth2376is marked by a checkered pattern that extends from the mandible2368to the hyoid bone2377.

23B. Front view. Floor of mouth2376connects to the bottom of each side of the mandible2398.

23C. Top view. Tongue2351is transparent and triangular root2349of tongue can be seen. The anterior extension of the root2349is the genioglossus muscle2363(seen inFIGS. 23A and 23B) insertion into the mandible2398.

23D. A bolster2340is pushed downward and slightly anterior by a shaft2310exerting a protracting force. Note the indentation of the floor of mouth2376and the altered position of the tongue2351and the PGF2357.

23E. The floor of mouth2376is depression by the bolster2340is reflected by decreased height of tongue2351surface.

23F. The bolster2340is seen from above. Note the anterior displacement of the base of the tongue2351.

23G. Side view. A vacuum device2347is a retractor member2320applied to the lateral tongue2351. The vacuum device2347is positioned below the tongue2351adjacent the floor of mouth2376and the PGF2357.

23H. Front view. A vacuum device2347is employed as a retractor member2320that displaces tongue2351tissue. Tongue2351tissue displacement is reflected by the decreased height of the tongue2351surface.

23I. Top view. A vacuum device2347is employed as a retractor member2320that displaces tongue2351tissue resulting in anterior displacement of the base of the tongue2351that avoids obstruction of the airway due to collapse of the tongue2351toward the soft palate2366(seeFIG. 23G).

23J. A view of another vacuum device2347employed as a tissue retractor.

23K. A close up view of the vacuum device2347ofFIG. 23Jemployed as a tissue retractor.

23L. A close up view of the vacuum device2347ofFIG. 23Kemployed as a tissue retractor.

23M. A close up view of another embodiment of a vacuum device2347.

23N. A close up view of another embodiment of a vacuum device2347.

The term “subject” as used herein includes animals of mammalian origin, including humans. Anatomical terminology used to describe position and orientation as used herein can best be defined by the following description:

When referring to animals, that typically have one end with a head and mouth, with the opposite end often having the anus and tail, the head end is referred to as the cranial end, while the tail end is referred to as the caudal end. Within the head itself, rostral refers to the direction toward the end of the nose, and caudal is used to refer to the tail direction. The surface or side of an animal's body that is normally oriented upwards, away from the pull of gravity, is the dorsal side; the opposite side, typically the one closest to the ground when walking on all legs, swimming or flying, is the ventral side. On the limbs or other appendages, a point closer to the main body is “proximal”; a point farther away is “distal”. Three basic reference planes are used in zoological anatomy. A “sagittal” plane divides the body into left and right portions. The “mid-sagittal” plane is in the midline, i.e. it would pass through midline structures such as the spine, and all other sagittal planes are parallel to it. A “coronal” plane divides the body into dorsal and ventral portions. A “transverse” plane divides the body into cranial and caudal portions.

When referring to humans, the body and its parts are always described using the assumption that the body is standing upright. Portions of the body which are closer to the head end are “superior” (corresponding to cranial in animals), while those farther away are “inferior” (corresponding to caudal in animals). Objects near the front of the body are referred to as “anterior” (corresponding to ventral in animals); those near the rear of the body are referred to as “posterior” (corresponding to dorsal in animals). A transverse, axial, or horizontal plane is an X-Y plane, parallel to the ground, which separates the superior/head from the inferior/feet. A coronal or frontal plane is an Y-Z plane, perpendicular to the ground, which separates the anterior from the posterior. A sagittal plane is an X-Z plane, perpendicular to the ground and to the coronal plane, which separates left from right. The mid-sagittal plane is the specific sagittal plane that is exactly in the middle of the body.

Structures near the midline are called medial and those near the sides of animals are called lateral. Therefore, medial structures are closer to the mid-sagittal plane, lateral structures are further from the mid-sagittal plane. Structures in the midline of the body are median. For example, the tip of a human subject's nose is in the median line.

Ipsilateral means on the same side, contralateral means on the other side and bilateral means on both sides. Structures that are close to the center of the body are proximal or central, while ones more distant are distal or peripheral. For example, the hands are at the distal end of the arms, while the shoulders are at the proximal ends.

DEFINITIONS

“Anchor” refers to a component of the device that mechanically couples to a site that is substantially immobile or substantially fixed relative to the retractor.

“Deformation” refers to an abnormal change in the shape of upper airway soft tissue structures. This deformation can be due to negative pressure acting on relaxed upper airway structures during sleep causing them to narrow the upper airway. Most preferably this soft tissue can be the tongue curve.

“Frenulum” refers to the vertical anterior edge of the genioglossus muscle. The frenulum passes from the floor of the mouth up to the centerline of the underside of the tongue. The frenulum marks the boundary between the tongue blade and tongue body.

“Frenulum area” refers to the genioglossus muscle and its surrounding mucosa.

“Loaded” refers to a tissue retractor (e.g., an LTR) that can have its tension adjusted such that it has minimal tension during the waking hours (e.g., “Unloaded”) and higher therapeutic levels of tension during the sleeping hours (e.g., “Loaded”). The loaded configuration corresponds to the higher therapeutic levels.

“Modified anchor” is an additional component that allows attachment of the permanent anchor of the tissue retractor. In some embodiments the modified anchor allows the patient to adjust tension in the tissue retractor, specifically to increase tissue retractor tension during the sleeping hours (e.g., at night) and to reduce tissue retractor tension during the waking hours (e.g., during the day).

“Palate retractor” refers to a complete device used for the prevention of soft palate deformation.

“Permanent anchor” refers to an anchor component of a tissue retractor that remains on the tissue retractor for the duration of the implantation. In some embodiments, the permanent anchor prevents the anterior end of the shaft from slipping back into tissue (e.g., tongue tissue). In certain embodiments the permanent anchor also serves to connect to a “modified anchor” when a modified anchor is used.

“Pharyngeal wall retractor” refers to a complete device for the prevention of pharyngeal wall deformation.

“Protract” means to lengthen or push apart.

“Reverse deformation” refers to a change in soft tissue shape caused by the tissue retractor. In some embodiments reverse deformation refers to restoring a deformed structure to its normal shape. In other embodiments reverse deformation refers to an indentation of soft tissue in a given area due to the action of a tissue retractor.

“Sleep breathing disorders” refers to all breathing disorders occurring during sleep including but not limited to obstructive sleep apnea, obstructive sleep apnea syndrome, upper airway resistance syndrome, and snoring.

“Tongue base” refers to the part of the tongue posterior to the tongue curve. In anatomical terms the line of demarcation of the tongue base is the circumvalatte papillae, a grossly visible line of raised taste organs on the superior surface of the tongue.

“Tongue blade” refers to the part of the tongue anterior to the frenulum. It is covered by mucosa on its top, sides and undersurface.

“Tongue body” is the mid part of the tongue located between the tongue blade and tongue base.

“Tongue boundary” or “boundary” is the inferior surface of the tongue body and base. The genioglossus muscle inserts onto a large part of the boundary.

“Tongue curve” refers to the area of the tongue where its superior surface curves from a horizontal orientation (tongue body and blade) to a vertical orientation (tongue base). Preferably tongue curve refers to the soft tissue in this area between the mucosal covering of the tongue and the connective tissue boundary where the genioglossus muscle attaches.

“Tongue retractor” refers to a complete device used for the prevention of tongue deformation. In some embodiments it includes a retractor connected to a shaft which in turn is connected to an anchor.

“Laryngeal retractor” refers to a complete device for the prevention of laryngeal soft tissue deformation.

“Retractor” or “retractor head” or “retractor member” refers to a part of an overall tissue retractor. The retractor physically interacts with soft tissue, either directly or indirectly, to prevent it from deforming. In certain embodiments the retractor head is a disc located on an external surface of the tongue, in other embodiments the retractor head is an inflatable balloon, in other embodiments the retractor head may have curved parts that act like hooks, in other embodiments the retractor head may be a flexible wire passing through the tissue, or in some embodiments the retractor is totally implanted within tissue.

“Shaft” refers to that part of the tissue retractor that attaches to the retractor head (e.g. the retractor member) and serves to connect it to the anchor member. The shaft may be one or more of rigid, flexible, solid, hollow, one piece, or multiple linked pieces.

“Unloaded” refers to a tissue retractor that exerts little or no tension. This is usually meant as the configuration during the waking hours (e.g., during the day). In comparison, the tissue retractor is loaded to therapeutic levels during the sleeping hours (e.g., a night).

EXAMPLES

Disclosed here, referring toFIG. 6A, is a tissue retractor601, which includes a retractor member (i.e., the retractor head620), a shaft610, and an anchor member. One end of the shaft610connects to the retractor member620and the other end of the shaft610connects to an anchor member (not shown). Referring toFIGS. 6B-6E, the tissue retractor601retractor member620is inserted into a tissue650by a needle635and the tissue retractor601automatically deploys to its working shape.

Referring now toFIG. 6E, the retractor head620prevents at least a portion of the tissue650(e.g., the tongue base) from deforming. For example, in one embodiment, the deployed tissue retractor601has a retractor head620that prevents deformation of at least a portion of the tongue base to prevent obstruction of the patient's airway.

The preferred qualities for a retractor head620that rests upon tissue650(e.g., tongue base mucosa) are that its depth is minimal so that it is not noticeable to the patient yet its surface area is large enough to provide sufficient counterforce. The counterforce is a pressure that prevents deformation of at least a portion of the tissue650(e.g., tongue base mucosa). Integral to its design is the delivery device (e.g., the needle635) used to insert the tissue retractor601(e.g., the LTR). In one embodiment, the entire device (e.g., the delivery device, the needle635, and the tissue retractor601disposed on the needle635) is inserted from the anterior tongue with minimal instrumentation used at the back of the tongue. Therefore the retractor head620preferably automatically deploys to its working shape (i.e.,FIG. 6E) after being implanted by a needle635inserted from the front of the tongue.

Part of this aspect of the invention includes improvements in the design of the retractor head620that allow it to be easily inserted. In certain embodiments, this insertion would be by a needle635. Therefore one embodiment of this invention is a retractor head620that folds within a needle635but deploys to its working shape after insertion. Many mechanisms are known that allow a device to be minimized for insertion in the body, non-limiting examples include nitinol wire, high pressure balloons, and spring mechanisms. These mechanisms work well but add complexity and unnecessary expense.

In one embodiment, the retractor component, the retractor head620, is oval shaped (10 mm long, 5 mm wide, 2.5 mm deep) and is molded together with the shaft610(1 mm in diameter) as a single piece from moderate consistency medical grade silicon (Shore 80 durometry, Nusil, Ca) (FIG. 6A). The retractor head620is tilted 75° in relation to the shaft610. When the tissue retractor601is threaded into the needle bore645of a needle635(FIGS. 6B-6C) one side of the oval retractor head620extends out of the needle635port and projects at a 15° angle relative to the outside wall of the needle635. When the needle635is inserted through tissue650this extension of the retractor head620is pushed flush against the needle635wall and causes a minimum increase in the needle635profile (FIG. 6C). However, immediately after the needle635passes through tissue650(e.g., mucosa) the retractor member620reverts to its extended position (FIG. 6D). The needle635is pulled back and removed from the tissue650causing the retractor member620to catch at least a portion of the tissue650(i.e., the mucosa), which prevents the tissue retractor601from being withdrawn along with the needle635from the tissue650. After the needle635is removed, minor tension on the shaft610causes the retractor head620to rotate into proper position and lay flush against the mucosa (FIG. 6E).

The practical advantage of this invention is that the physician can rapidly and easily insert and withdraw the needle635and the tissue retractor601device automatically settles into its proper position when the retractor head620deploys and contacts the tissue650.

Referring now toFIGS. 7A-7C, disclosed here is a modified shaft710that adapts its length to avoid interfering with normal movements of the tongue751(e.g., the tongue base).

The counterforce exerted against the back of the tongue751base is preferably present during sleep but not during the awake state. More preferably, the counterforce is present when the tongue751is relaxed and vulnerable to posterior collapse, but not during speech and swallowing. During swallowing the tongue base moves rapidly backward about 1 cm to contact the back wall of the pharynx. The tongue base moves similarly during some speech movements, albeit with much less force. It is desirable that these swallowing and speech movements are not impaired.

In one embodiment of the shaft710the section within the tongue751is a distensible portion711, one non-limiting example being a balloon. Compression of the balloon portion711of the shaft710allows the shaft710to lengthen. During swallowing the tongue751contracts forcefully around the shaft710. This contraction squeezes the balloon portion711and lengthens it, thereby displacing the retractor head720superiorly. As the tongue base moves superiorly in the area of the retractor head720during swallowing, the compression exerted on the shaft710causes the shaft710to lengthen proportionally and prevents the retractor head720from exerting unneeded counterforce on the tongue base during swallowing. However, the ability to exert the proper amount of counterforce when the tongue751is relaxed is maintained. The amount of distensibility is from about 0.01 cm to about 10 cm, or about 1 cm.

The decrease of counterforce by the retractor head720during swallowing and speech can be accomplished by many known mechanical and electromechanical mechanisms. Those skilled in the art can readily appreciate that the invention can have multiple embodiments.

Disclosed here are modified anchors that allow reversible loading of an implanted tissue retractor (i.e., LTR).

Referring now toFIGS. 8A-8H, the anchor830is the anterior component of the tissue retractor801(i.e., LTR) that resists displacement of the shaft810and retractor head820. In a preferred embodiment the tissue retractor801(i.e., LTR) is under little or no tension during the day (unloaded state) and is adjusted to exert tension at night (loaded state). In this embodiment the anchor830merely prevents the anterior end of the shaft810from being pulled back into tongue tissue851. For this purpose a small flange is sufficient. However, at night when further retractor counterforce is desired, the anchor830can be replaced, modified, or supplemented; collectively referred to as a modified anchor.

One embodiment of a modified anchor is a bolster840that is interposed between the permanent anchor830and the tongue851. This bolster840either lengthens the shaft810, or if the shaft810is set at a fixed length it increases the total volume compressed between retractor head820and shaft810. In either case the addition of the modified anchor (e.g., the bolster840) causes a reversible increase in retractor820counterforce.

In one embodiment of the modified anchor the bolster840is composed of silicon gel and is shaped as a V (FIGS. 8A-8C). The concave inner surface of the ‘V’ adapts to the wedge shape of the frenulum860, the structure underneath the tongue blade852. The intent of the ‘V’ shape is to spread the retracting counterforce across a wide surface area of the frenulum860. In the center of the anchor830bolster840is a conduit through which the permanent anchor830and shaft810is threaded. In one embodiment the conduit is a cleft848beginning in the center of the top center edge. This cleft848is about the width of the shaft810but less then that of the permanent anchor830. The patient can reach under the tongue851and pull the permanent anchor830forward in direction899(FIGS. 8D-8F), slip the bolster840under the tongue851, lay the shaft810into the cleft848, and release the permanent anchor830. The permanent anchor830then securely rests against the front surface of the cleft848and exerts force. The cleft848may be reinforced with a harder grade of silicon or another biocompatible material.

Another embodiment of this invention is to secure the permanent anchor to a modified bolster that is permanently or reversibly attached to the teeth, a dental anchor (FIGS. 9A-9E). Many devices that attach to teeth are known in the art. A non-limiting example is ‘T’ shaped. The top cross bar of the “T”932rests against the front surface of the lower incisor teeth998. The initial section of the vertical line of the “T”932is thin enough to pass between the front two incisor teeth998. This vertical part widens to allow the retractor head920to be threaded. The final part of the “T”932narrows again to about the width of the shaft910. This mechanism allows the anchor930to be easily and reversibly attached to the dental bolster (FIGS. 9A-9B).

Another embodiment is a dental anchor931optimized for use on the sides of the mouth rather then the front. This embodiment (FIGS. 9C-9D) anchors931to a molar or premolar tooth998or neighboring structures. This embodiment is advantageous due to the short distance between the tissue retractor (e.g., an LTR) and the modified anchor, its position on the lateral aspect of the tongue951is unlikely to interfere with normal tongue function, and it is easily accessible for placement, adjustment and removal by patient and physician.

In a further embodiment a dental prosthesis is used as an anchor disposed in the soft palate, the palatoglossal folds, the pharyngoglossal folds, the tongue, or other upper airway sites to anchor to a tissue retractor. Dental prostheses are well known in the dental arts. In some embodiments, dental prosthesis provide a wide and stable platform for anchoring embodiments of a tissue retractor. Further embodiments can take advantage of the large size and position of these prostheses.

Referring now toFIG. 9E, in one embodiment, the anchor member903is a palatal prosthesis972. The palatal prosthesis972is disposed on a portion of the soft palate966. For example, the palatal prosthesis972may be disk disposed on a surface of the soft palate966. Alternatively, the palatal prosthesis972may be a hook disposed inside a portion of the soft palate966. The palatal prosthesis972may be a suction cup disposed on a portion of the soft palate966. In one embodiment, a tissue retractor901A includes a retractor member920A disposed on another portion of the soft palate966, the anchor member930is the above described palatal prosthesis972, and a shaft910A is disposed between the retractor member920A and the anchor member930. The placement of the retractor member920A and the palatal prosthesis972can be selected to enlarge the airway in the area around the soft palate966. In another embodiment, a tissue retractor920B is disposed on the surface of the tongue951. For example, the tissue retractor920B is a tongue stud on the surface of the tongue951. The tongue stud may be part of a conventional tongue piercing. The shaft910B connects the tongue stud to the palatal prosthesis972. The shaft910B can have an end that connects to the tongue stud retractor member920B by encircling or looping about all or a portion of the tongue stud. The shaft910B can be an elastic material. The retractor member920B is pulled toward the direction of the palatal prosthesis972thereby enlarging the airway behind the tongue base953. In one embodiment, a retractor member920C is disposed in the floor of the mouth976. A shaft910C is disposed between the palatal prosthesis972and the floor of the mouth976.

In one embodiment, the retractor member920C provides a protraction force that is directed to push the floor of the mouth976in the direction opposite the palatal prosthesis972. More specifically, in one embodiment, the protraction force is directed inferiorly. The protection force can be provided by the shaft910C. The shaft910C can be a rigid material. Alternatively, the shaft910C is made from a material that lengthens. The shaft910C can have passive properties that enable it to lengthen, for example, the shaft910C can include a compressed elastic, a compressed spring element, or a nitinol wire, for example. In one embodiment, the shaft includes a pressurized fluid, an electric motor or other means that exert a lengthening force. For example, the shaft910C can include two hollow tubes with one tube sliding within the other tube to change the overall tube length. In another embodiment, the shaft910C is a fixed length that is longer than the distance between the palatal prosthesis972and the floor of the mouth976.

In one embodiment, a bolster is disposed between the shaft910C and the floor of the mouth976such that the shaft910C does not contact mucosa on the floor of the mouth976. The bolster improves the patient's comfort. In one embodiment, the bolster feels soft and/or pliable and is biocompatible. The bolster can range in size from a 0.1 cm long by 0.1 cm wide square or to the entire surface area of the floor of the mouth. In one embodiment, the bolster is 0.5 cm wide and 1.5 cm long. Suitable bolsters are sized to fit on the floor of mouth976adjacent the patients tongue951. The bolster may be positioned along the floor of the mouth from the front wall of the PGF967to the back wall of the mandible968behind the lower incisor teeth. In one embodiment, the shaft910C exerts force to the area of the floor of mouth976directly infront of the PGF967such that the protraction force of the shaft910C pushes a bolster such that the force is transmitted to the tongue base953.

In one embodiment, a retractor member920D is disposed in the PGF967. A shaft910D is disposed between the palatal prosthesis972and the retractor member920D. The shaft910D may be a rigid material or it may be a material that lengthens when exposed to a force. The shaft910D exerts force by protraction or inferior force on the PGF967. Because the PGF967is attached to the tongue base953the force exerted by the shaft910D on PGF967is directly transmitted to the tongue951, which causes protraction of the tongue base953thereby opening the patient's airway.

Referring still toFIG. 9E, in one embodiment, a tissue retractor for treatment of a breathing disorder includes an anchor member930sized for placement on or in a patient's soft palate and a shaft910having a first end and a second end, the first end connected to the anchor member930. The tissue retractor also includes a retractor member920connected at or near the second end of the shaft910. At least one of the shaft910and the retractor member920is positioned on or in a soft tissue located in the patient's oral cavity or pharynx. The anchor member930, the shaft910, and the retractor member920exert a force that prevents deformation of at least a portion of the soft tissue to prevent obstruction of the patient's airway. The force may be a retraction force or, alternatively, a protraction force. The retractor member920may be positioned on or in the soft palate, the pharyngoglossal fold, the floor of mouth, or the tongue, for example. In one embodiment, the retractor member920is a tongue stud on the surface of a tongue951.

A method for treatment of a breathing disorder can include positioning a palatal prosthesis972on or in the patient's soft palate, positioning a retractor member920on or in a soft tissue located in the patient's oral cavity or pharynx, connecting a first end of a shaft910to the palatal prosthesis972, and connecting a second end of the shaft910to the retractor member920. At least one of the palatal prosthesis972, the shaft910, and the retractor member920interact to exert a force that prevents deformation of at least a portion of the soft tissue to prevent obstruction of the patient's airway Optionally, as discussed above, to maximize adjustability, a bolster may be inserted between the end of the shaft910and the patient's tissue, for example, the bolster may be inserted between the shaft910and the floor of the mouth976. At least one of the palatal prosthesis972, the shaft910, and the retractor member920interact to exert one of a retraction force or a protraction force that prevents deformation of at least a portion of the soft tissue to prevent obstruction of the patient's airway.

Those skilled in the art can understand that a variety of electrical or mechanical mechanisms could be incorporated within these dental prosthesis. As a non-limiting example, an electrical motor could be used to control the force applied to coupled tissue retractors at multiple locations in the upper airway.

Referring now toFIGS. 10A-10C, in still another embodiment, the modified anchor1031is partially implanted into the floor of the mouth. In one embodiment of this invention a puncture is made across the frenulum1060or soft tissue structures of the floor of the mouth. The frenulum1060has a central tendon1067. Generally, the frenulum area1060B includes the whole genioglossus1063and its surface mucosa. The frenulum1060A includes the front edge of the frenulum area1060B. In one embodiment, a shaft (e.g., a flexible shaft) is threaded through the puncture and the ends are connected to create the modified anchor1031, a ring like structure. The modified anchor1031is securely fixed within tissue (FIG. 10). In one embodiment, during sleeping hours (e.g., at night) the modified anchor1031is reversibly attached to the permanent anchor of a tissue retractor and the modified anchor1031is disengaged from the permanent anchor of the tissue retractor during waking hours (e.g., in the morning).

Referring now toFIGS. 11A-11E, disclosed are methods and devices for retracting or preventing deformation of the tongue base1153by retracting the genioglossus muscle1163or the boundary fascia1161upon which the genioglossus muscle1163inserts (this area is collectively referred to as the frenulum area1160).

It has been unexpectedly found that the shaft1110of the tissue retractor1101(i.e., an LTR) can be safely passed across the undersurface of the tongue1151. The undersurface of the tongue1151contains the frenulum area1160, which is the mucosa covering the genioglossus muscle1163. Thus, this under tongue1151tissue contains the genioglossus muscle1163and its anterior edge is the frenulum1160(FIGS. 11A-11B). A central tendon1167is substantially in the center of the genioglossus muscle1163spanning from the mandible1168up to the undersurface of the tongue1151. The genioglossus1163muscle originates from the mandible1168and has multiple separate muscle fascicles1164that fan out from a horizontal to vertical angle. The genioglossus fascicles1164attach to a layer of connective tissue within the tongue1151called the boundary1161(FIGS. 11A-11B, dotted line). The genioglossus fascicles1164normally act by exerting force in the axis of the fascicle1164onto the part of the boundary1161to which the fascicles1164are attached. However, even when inactive, the fascicles1164are mechanically coupled to the tongue boundary1161and can exert a force on the tongue1151if the fascicles1164passively move. Unexpectedly, movement of a portion of the tongue1151can be done by pulling these fascicles1164perpendicular to their axis (FIG. 11C). To simplify the mechanism, in one embodiment, the genioglossus fascicles1164are lassoed by the tissue retractor1101, which in one embodiment, is made from the shaft1110. In one embodiment, the force provided by the tissue retractor1101in the genioglossus1163is substantially evenly distributed.

There are certain important considerations in placing a retractor through the genioglossus1163: First, the genioglossus1163is soft in comparison to the tongue base1153, therefore, too much force applied in a localized area of the genioglossus1163can tear the tissue or cause undesirable tissue remodeling over time, sometimes called the “cheese cutter effect”. However, there is a central tendon1167to the genioglossus1163that is very strong. This central tendon1167is located approximately 1 cm from the edge of the frenulum area1160. In one embodiment, the tissue retractor1101is located anterior to the central tendon1167. In another embodiment, the tissue retractor1101is disposed posterior to the central tendon1167. Second, the nerve supply to the genioglossus1163passes along the superior aspect of the muscle, therefore the top 0.5 cm of the muscle, the area1199directly below the tongue blade1152, is not a preferable site for the tissue retractor1101implant.

In one embodiment, the tissue retractor1101is a shaft1110that has a 5 cm length of elastomeric material that is ribbon shaped. The cross sectional dimensions of the shaft1110are 0.5 mm depth and 3 mm width. The wider dimension of the width of the shaft1110will exert force on a wider area of the genioglossus1163tissue, because, due to its dimensions, the shaft1110force is dispersed over a wider area then the narrow edge of the ribbon. The tissue retractor1101shaft has a length that ranges from about 0.5 cm to about 5 cm, a width that ranges from about 0.1 mm to about 10 mm, and a depth that ranges from about 0.1 mm to about 2 mm.

During insertion of the tissue retractor1101into the frenulum area1160, the shaft1110is attached to a needle and passed through the genioglossus1163muscle approximately 1 cm behind the frenulum1060A. Referring now toFIG. 11D, the ends of the shaft1110are then reversibly coupled to a modified anchor1131. The middle section of the shaft1110itself exerts anterior retracting force onto the genioglossus muscle1163and acts as a retracting head. One or both ends of the shaft1110can then be brought forward and secured to a modified anchor1131. In one embodiment, the location or angle of the modified anchor1131is selected to enable a desired position of the tissue retractor1101in the genioglossus muscle1163. In another embodiment, the modified anchor is a tooth. The position of the tissue retractor1101is determined based upon the anatomy of the tongue1151.

This displacement of the genioglossus muscle1163is transmitted to the tongue base1153causing some degree of concavity in the tongue base1153. The passive movement is preferably in an anterior and inferior direction. In one embodiment, the displacement of the genioglossus muscle1163is transmitted to the tongue base1153and prevents the tongue base1153from obstructing the patient's airway. For example, the displacement of the genioglossus muscle1163prevents the tongue base1153from falling toward another tissue in the patient's airway.

The advantages of genioglossus muscle1163retraction is that this muscle group is easily accessible beneath the tongue1151. The tissue of the genioglossus muscle1163is soft and easily compressed, making it easy to pierce without complications. The position under the tongue1151is invisible to others, a quality important for the patient.

A further embodiment of this invention is to pass the tissue retractor1101(e.g., the LTR) deeper into the tongue1151to couple directly to the boundary layer1161(FIG. 11D). The boundary layer1161is a relatively firm connective tissue structure which spans the length of the body of the tongue1151. In one embodiment, the boundary layer1161receives the insertion of the tissue retractor1101through the genioglossus muscle1163. For example, the shaft is in the genioglossus muscle1163and the anchor member and retractor member loop around some of the boundary layer1161to get firm traction. The advantages of coupling to the boundary layer1161are that it provides a more secure attachment then the genioglossus1163itself. However, greater care is needed for placement of the tissue retractor1101device. Specifically the lingual arteries course just superior and lateral to the boundary layer1161so it is essential that the insertion of the shaft1110of the tissue retractor1101be made medial to the structure of the lingual arteries.

In a further embodiment, a fully implanted tissue retractor1101(e.g., an LTR) connects one site that effects the tongue base1153and is anchored at another site that does not. A non-limiting example of a fully implanted tissue retractor1101is shown inFIG. 11E. Here the posterior boundary layer1161ais coupled to the anterior boundary layer1161b. Tension between the two sites displaces the tongue base1153forward. Simultaneously there is some displacement force exerted around the anterior boundary site1161b, but the displacement force on the anterior boundary site1161bhas insignificant effects on normal tongue1151function.

The tissue retractor1101may have a shape other than the ribbon shaped shaft1110, however, the tissue retractor1101is positioned to take advantage to the genioglossus muscle1163and/or the behavior of the genioglossus fascicles1164. In one embodiment, multiple tissue retractors1101are positioned in the frenulum area1160to prevent the tongue base1153from obstructing the patient's airway.

Disclosed here are methods of implantation and devices that are implanted within the tongue and exert highly localized forces to prevent mechanical decoupling of tongue base structures.

Chronic implants within the tongue are technically challenging and potentially dangerous. The tongue is a mobile structure and tongue movements during swallowing and speech are dependent on this mobility. The tongue has no bones within it and its mechanism of movement is unique among the muscular structures of the body. Most skeletal muscles are attached to bones and movement occurs as mechanical levers. In the tongue, structures cause movement by expanding and changing their shape and volume. The mechanism is called a muscular hydrostat and is can be likened to a flexible hydraulic system. In addition, the tongue has extensive nerve and blood supply that can be easily damaged. Moreover, the tongue has a tremendous ability to remodel itself when effected by implants and other forces. When the tongue remodels itself, it adapts quickly to pressure exerted on its structure. In response to the pressure exerted on a portion of the tongue by, for example, an implant, the portion of the tongue reshapes to become, for example, thinner in region of the pressure exerted by the implant. This thinning of the tongue tissue is one reason why many prior art devices have failed, due to gradual loss of tension or extrusion. Moreover any implant is a potential site for infection and scarring. For these reasons any invasive intervention in the tongue must be designed with a detailed knowledge of tongue anatomy and physiology. Therefore, the implanted embodiments disclosed in this invention are carefully designed to be minimally invasive and to focus their effects on critical areas of pathology without risking interference with normal function.

Referring now toFIGS. 12A-12F, an implanted tissue retractor1201(e.g., an LTR) disclosed here is a very minimal device implanted into the tongue1251for example, in the tongue base1253. The implanted tissue retractor1201attaches to structures within the tongue1251to prevent a portion of the tongue1251from obstructing the patient's airway by, for example, falling toward another structure in the patient's oral cavity or pharynx. In some embodiments, the at least a portion of the implanted tissue retractor1201is made from a flexible material that does not impede the mobility required for normal tongue1251function.

The tongue1251is covered by mucosa and this mucosa has underlying connective tissue1256. The connective tissue1256is thickest below the superior surface of the tongue1251. The connective tissue1256is a collagenous structure covered in mucosa in the superior layer (SL)1258of the tongue1251. This superior surface is intimately connected to the underlying superior longitudinal muscle. Together the mucosa connective tissue1256and muscle form a superior layer (SL)1258that spans the superior surface of the tongue1251from the tongue tip to its base1253. This superior layer is normally coupled to the underlying middle layer (ML)1254of the tongue1251, which is largely composed by the transverse muscle. The transverse muscle originates from a fascial sheet called the medial septum (MS)1255oriented in the centerline of the tongue (mid-sagittal plane).

Although not wishing to be bound by theory, studies by the inventor suggest that the vibration during snoring and the stretching during airway obstruction gradually loosen the attachment of the superior layer1258to the middle layer1254. This is reflected by a mechanical decoupling, a widening of the superior layer1258in the area of the tongue curve, marked by an oval inFIGS. 12D-12E. This mechanical decoupling results in a more flaccid and compliant tongue base1253that deforms more easily when the pressure in the airway decreases, thereby making the patient susceptible to sleep apnea and other sleep breathing disorders.

In one embodiment (see,FIGS. 12C and 12F) of the invention a very small tissue retractor1201(e.g., an LTR) is inserted at the curve of the tongue base1253to correct the mechanical decoupling of the tongue layers. In one embodiment, the tissue retractor1201(e.g., an LTR) is symmetrical with an arrowhead shaped retractor head and an arrowhead shaped anchor. Each end of the tissue retractor1201(e.g., an LTR) mechanically hooks into soft tissue. Preferably, the tissue retractor1201is connected between the connective tissue fascia of the mucosa1256and the midline septum1255. Each end of the tissue retractor1201can have a hooking mechanism. The hooking mechanism can be varied and many variations are known in the art. Non-limiting examples of suitable hooking mechanisms on the tissue retractor1201are: hooks, barbs, helixes, staples, screws, sutures, biointegrated permanent material, collagen, and elastin. The hooking mechanism on each end of the tissue retractor1201can be the same as one another or can be different from one another. The tissue retractor1201has an anchor member and a retractor member connected by a shaft. For example, in one embodiment, the anchor member is a staple and the retractor member is a hook. However, in one embodiment, the tissue retractor1201has a short elastic shaft with a hook of firmer consistency at either end.

In one embodiment, a breathing disorder is treated with a tissue retractor1201in which a retractor member is connected at a first end of a shaft and an anchor member is connected at a second end of the shaft. The shaft is inserted into a patient's tongue1251between the superior layer1258and the middle layer1254. One of the retractor member and the anchor member is attached to the mucosa tissue fascia, for example, to the connective tissue1256. The other of the retractor member and the anchor member is attached to the midline septum1255tissue fascia. At least one of the shaft, the retractor member, and the anchor member interact to exert a pressure that prevents a portion of the patient's tongue1251from obstructing the patient's oral cavity or pharynx. The tissue retractor1201prevents a portion of the patient's tongue1251from moving toward other soft tissue located in the patient's oral cavity or pharynx. As a result, the airway is maintained in the open position. In some embodiments, the pressure is a counterforce pressure. In other embodiments, the pressure is exerted on the tongue base1253. In some embodiments, the portion of the patient's tongue is the midline septum1255of the tongue1251. The middle layer1254of the tongue1251can include the midline septum1255. In some embodiments, the tissue retractor1201(e.g., the retractor member, the shaft, and the anchor) are positioned on a needle, the needle is inserted to a desired depth within the patient's tongue1251, the needle is removed, and the tissue retractor1201remains where inserted in the patient's tongue1251.

In alternative embodiments, the implanted tissue retractor1201(e.g., an LTR) can vary in overall length from 1 mm to 3 cm in length. Alternatively, longer length tissue retractors1201(e.g., LTR's) can couple the tongue base1253tissue to the boundary fascia1261. The tissue retractor1201can couple the tongue1251and genioglossus muscle1263, through the boundary layer1261to the genioglossus muscle1263. The tissue retractors1201can couple the tongue1251to the floor of the patient's mouth or to the mandible. Coupling of the tissue retractor1201to the patient's tissue can be accomplished via barbs, hooks, fibrotic reaction, or other methods known in the art. The tissue retractor1201implant can be composed of biodegradable material that decomposes in from about a week to about a year, for example. Many materials used for surgical sutures can be adapted for use in a tissue retractor1201to enable the material to be biodegraded or bioresorbed when implanted in the body of the patient.

Preferably the shaft of the tissue retractor1201is oriented such that the force on the retractor is at least one orientation that includes downward, forward, and to the side. In one embodiment, the tissue retractor1201is oriented a combination of downward and forward. Multiple tissue retractor1201implants may be used along the midline of the tongue1251to distribute the coupling force without interfering with normal function. Depending on the anatomy of the patient, tissue retractor1201implants may be inserted at any site in the tongue1251. In one embodiment, the tissue retractor1201is implanted in the midline septum1255of the tongue1251. In another embodiment, the tissue retractor1201is implanted in the midline of the tongue curve1253. One or more of the following aspects of the tissue retractor1201can be used to mold the effects of the tissue retractor1201for the exact needs of the individual patient: implant site and orientation, shaft length and elasticity, and hook size, shape, and hardness.

The tissue retractor1201implant may be bioresorbable over a period of from about 1 day to about 10 years, or from about 1 month to about 1 year, or from about 1 month to about 6 months. Preferably, the time range allows sufficient time for remodeling of the tongue1251in a manner that avoids breathing disorders such as snoring and sleep apnea, for example. In one embodiment, a the tissue retractor1201implant is bioresorbed, which is preferable to a tissue retractor1201implant that is permanently left in the tongue, without bioresorption.

It is preferable that permanent or bioresorbable tissue retractor1201implants be inserted into superficial levels of the tongue1251in areas normally not undergoing a great amount of shape change during normal tongue1251activity. Such positioning minimizes the possibility that the tissue retractor1201implantation will impede normal function, particularly if there is an infection or fibrous reaction to the implant. To plan for atraumatic removal of the implant in cases of, for example, infection, pain or other complication, the tissue retractor1201implant should be designed to be easily removed from the patient's tongue1251without extensive surgery. To facilitate removal of the tissue retractor1201implant, the tear strength of the ends of the tissue retractor1201(e.g., the tear strength of either the retractor member or the anchor member or both) should range from about 1 to about 1000 grams. In one embodiment, the tear strength of hooking mechanisms at each end of a tissue retractor1201is about 500 grams. In another embodiment, the tear strength of the ends of the tissue retractor1201should range from about 10 to about 100 grams. In one embodiment, where the ends of the tissue retractor1201has hooks with one or more arms at the first end, then one or more of the arms of the hook fold straight at a tear strength limit, which allows the tissue retractor1201implant to be removed from the patient's tongue1251without further damage to tissue of the tongue1251as the tissue retractor1201is extracted.

In further embodiments, referring now toFIGS. 12A-12F, a method for treatment of a breathing disorder employs a tissue retractor1201, which includes a retractor member connected at or near a first end of a shaft and an anchor member connected at or near a second end of the shaft. In accordance with the method, a shaft is inserted into a patient's tongue1251between the superior layer1258and the middle layer1254. One of the retractor member and the anchor member is attached to the mucosa tissue fascia. The other of the retractor member and the anchor member is attached to the midline septum1255tissue fascia. At least one of the shaft, the retractor member and the anchor member interact to exert a counterforce pressure that prevents a portion of the patient's tongue1251from obstructing the patient's oral cavity or pharynx. The method can also include positioning the tissue retractor1201, namely the retractor member, the shaft, and the anchor member, on a needle and inserting the needle to a desired depth within the patient's tongue1251, and thereafter removing the needle to leave the tissue retractor1201inserted in the patient's tongue1251.

In some embodiments, the portion of the patient's tongue1251that is prevented from obstructing the patient's oral cavity or pharynx is the base1153of the patient's tongue. In some embodiments, one or more of the shaft, the retractor member, and the anchor member is bioresorbable. After insertion of the tissue retractor1201into the patient's tongue1251all or a portion of the tissue retractor1201is bioresorbed by the patient's body. In some embodiments, the portion of the patient's tongue1251is the midline of the tongue. The middle layer1254can be the midline septum1255.

Disclosed here are embodiments of the invention that focus on retracting tissue of the tongue base, particularly the tongue base mucosa. This has the advantage that it is easy to insert by the physician, minimally invasive and easily adjustable by the patient.

Referring now toFIGS. 13A-13D, in one embodiment, the tissue retractor1301device is inserted from one site to another site and both sites are on the superior surface of the tongue1351, which can include the tongue base surface. The anterior part of the tissue retractor1301device is the anchor member1330and the posterior part is the retractor member1320. In the tissue retractor, a shaft1310runs between the anchor member1330and the retractor member1320. Tension between the retractor member1320, the shaft1310, and the anchor member1330, retracts the tongue1351surface and displaces the tongue base. Although the counter traction of the tissue retractor1301affects the anterior tongue surface, it has no effect on normal tongue1351function.

In one embodiment, referring toFIG. 13A, the shaft1310of the tissue retractor1301passes directly underneath the mucosa of the tongue1351. In another embodiment, referring toFIG. 13B, the shaft1310takes a more direct line through the tongue1351. Passing the shaft directly underneath mucosa of the tongue1351(see,FIG. 13A) is easier for the physician than inserting it directly through the tongue1351(see,FIG. 13B). In the configuration shown inFIG. 13A, the force at the retractor member1320(e.g., the retractor head) is oriented laterally, and this causes the mucosa posterior to the retractor member1320to be pulled taut with some degree of indentation. In the more direct route inserted through the tongue1351and shown inFIG. 13B, the retraction force of the retractor member1320is oriented close to perpendicular to the tongue surface and there is more indentation then mucosal tension as compared to the less direct route where the shaft1310passes directly underneath the mucosa of the tongue1351. The exact orientation of the tissue retractor1301and the insertion path of the tissue retractor1301can be varied to maximize the beneficial effects of the tissue retractor1301in the patient's tongue1351.

Referring now toFIG. 13C, in another embodiment, the tissue retractor1301shaft1310runs most of its course along the surface of the tongue1351. A portion of the shaft1310is disposed under the mucosa close to the retractor member1320and is connected to the retractor member1320, another portion of the shaft1310is disposed under the mucosa close to the anchor member1330and is connected to the anchor member1330, and the remainder of the shaft1310is disposed along the external surface of the tongue1351. This has the advantage of avoiding even the minimally invasive tunnels formed byFIGS. 13A and 13B. Furthermore the configurations disclosed inFIGS. 13A,13B, and13C, can be combined and the shaft1310can travel the entire distance under the mucosa or can re-emerge one or more times (13. C).

In another embodiment, referring now toFIGS. 13D-13H, at least a portion of the anchor member1330and/or at least a portion of the retractor member1320can be embedded beneath mucosa on the soft tissue1350and the shaft1310is, optionally, detachable. In one embodiment the anchor member1330has a first portion and a second portion and/or the retractor member1320has a first portion1321and a second portion1322. The first portion (e.g., of the anchor member and/or the retractor member1321) has one diameter and the second portion (e.g., of the anchor member and/or the retractor member1322) has another diameter. The first portion has a diameter that ranges from about 1 mm to about 20 mm, from about 2 mm to about 10 mm, or from about 3 mm to about 7 mm. The second portion has a diameter that ranges from about 1 mm to about 20 mm, from about 2 mm to about 10 mm, or from about 3 mm to about 7 mm.

In one embodiment, referring toFIGS. 13E-13H, the first portion1321is a silastic disc about 5 mm in diameter that is implanted under the mucosa of the soft tissue1350. The second portion1322has a 1 mm diameter extension1323that comes out of the pocket of soft tissue1350in which the first portion1321is implanted. The extension1323ends in a second portion1322which, in one embodiment, is a 2 mm disc. The shaft1310reversibly couples to the extension1323between the first portion1321and the second portion1322. Preferably, shafts1310are elastomeric. In one embodiment, the shaft1310is a simple medical grade rubber band. In another embodiment, the shaft1310is a 1×1 mm strip of elastomeric material with expansion at either end to accommodate precut keyholes for attachment (e.g., reversible attachment) to an external portion of an implanted anchor member1320or retractor member1330. In one embodiment, the attachment holes have 2 mm or greater inner keyholes to allow the end of the stretched shaft1310to pass over the retractor second portion1322and/or the extension1323and 1 mm outer holes or clefts that slot into the extension1323. In some embodiments, materials of the tissue retractor are pigmented to match the color of the tongue mucosa1350. Referring now toFIG. 13H, in a further embodiment, the patient is allowed to depress the elevated extension1323and/or the retractor second portion1322so that it is flush with the mucosa, particularly when the tissue retractor is not in use. Suitable mechanisms known in the art may be used to allow reversible depression of a button like device of the retractor member1320.

In a further embodiment, referring toFIG. 13I, an anchor member1330is composed of an elastic sleeve or band1370slipped over the tongue1351blade. The shaft1310may be an integral part of the band1370or, alternatively, the shaft1310is a separate attachable component. The band1370may be made of biocompatible materials such as silicone or other biocompatible elastomers. The distal end of the shaft1310can be reversibly attached to a portion of the retractor member1320. In one embodiment, referring again toFIGS. 13E-13H, the shaft1310reversibly couples to the extension1323between a first portion1321and the second portion1322. In another embodiment, a portion of the shaft1310reversibly attaches to the second portion1322of the retractor member1320.

Suitable mechanisms by which a portion of the shaft1310and the implant (e.g., the retractor member1320) are coupled may include elastic bands, clips, magnets of opposite polarity, a first magnet and a material of opposite polarity, and other mechanisms well known to those skilled in the art. The advantages of this arrangement are that only a small partially embedded implant (e.g., retractor member1320having an implanted first portion1321and a second portion1322) is needed to achieve retraction of the soft tissue1350(e.g., a portion of the tongue1351).

Referring now toFIGS. 13A-131, a tissue retractor1301for treatment of a breathing disorder has a retractor member1320with a first portion1321sized for implantation into a soft tissue located in a patient's oral cavity or pharynx and a second portion1322sized for placement external to the soft tissue. A portion of a shaft1310(e.g., the first end1311of the shaft1310) contacts the second portion1322of the retractor member1320and another portion of the shaft1310connects at or near an anchor member1330. At least one of the retractor member1320, the shaft1310, and the anchor member1330interact to exert a pressure that prevents deformation of at least a portion of the soft tissue that prevents obstruction of the patient's airway. In one embodiment, the shaft1310is external to the soft tissue. In some embodiments, a first end1311of the shaft1310connects at or near the anchor member1330, a second end of the shaft1310connects at or near a second anchor member1330, and the portion of the shaft1310exerts the pressure on the second portion1322of the retractor member1320. In some embodiments, the anchor member1330is a first magnet, the first end1311of the shaft1310comprises a second magnet that attracts to the first magnet, the second anchor member1330comprises a third magnet, and the second end of the shaft1310comprises a fourth magnet that attracts to the third magnet.

In some embodiments, the second portion1322of the retractor member1320has a low profile when not contacting the shaft1310.

The anchor member1330can be a band1370surrounding at least a portion of the external diameter of a patient's tongue1351. The anchor member1330can be a stud (e.g., a tongue stud commonly used in tongue piercing typically associated with non-medical and cosmetic applications) on the external surface of a patient's tongue1351.

In some embodiments, a method for treatment of a breathing disorder includes implanting a first portion1321of a retractor member1320into a soft tissue located in a patient's oral cavity or pharynx with a second portion1322of the retractor member exterior to the soft tissue. A first end1311of a shaft1310is connected to the retractor member1320and an anchor member1330is connected to a second end of the shaft1310. At least one of the retractor member1320, the shaft1310, and the anchor member1330interact to exert a pressure that prevents deformation of at least a portion of the soft tissue that prevents obstruction of the patient's airway. The shaft may be external to the soft tissue. The second portion1322of the retractor member1320has a low profile when not connected to the first end1311of the shaft1310. In some embodiments, the anchor member1330has a first portion implanted in a soft tissue located in a patient's oral cavity or pharynx and an anchor member1330second portion external to the soft tissue. In some embodiments, the anchor member1330is a band1370surrounding at least a portion of the external diameter of a patient's tongue1351. In other embodiments, the anchor member1330is a stud on an external surface of the patient's tongue1351. In one embodiment, at least a portion of the retractor member1320is positioned in the region of the pharyngoglossal fold.

In some embodiments, referring now toFIG. 13J, a first anchor member1330is positioned in a first region of soft tissue located in a patient's oral cavity or pharynx and a second anchor member1330is positioned in a second region of soft tissue. A first portion of a retractor member1320is inserted into a third region of soft tissue located in the patient's oral cavity or pharynx and a second portion of the retractor member1320is exterior to the third region of soft tissue. A first end of a shaft1310is connected at or near the first anchor member1330and a second end of the shaft1310is connected at or near the second anchor member1330. One or more of the first anchor member1330, the second anchor member1330, the retractor member1320, and the shaft1330interact to exert a pressure that prevents deformation of at least a portion of soft tissue to prevent obstruction of the patient's airway. In one embodiment, at least a portion of the shaft exerts a pressure on the retractor member that prevents deformation of the third region of soft tissue. In one embodiment, the first anchor member1330is a first magnet, the first end of the shaft1310is a second magnet that attracts to the first magnet, the second anchor member1330is a third magnet, and the second end of the shaft1310is a fourth magnet that attracts to the third magnet. Optionally, one of the above-described magnets is replaced with a material other than a magnet (e.g., a ferrous material) to which another magnet is attracted.

In some embodiments, referring still toFIG. 13J, an anchor member1330is placed in each PGF1357. The anchors1330are attachment points for a shaft1310(e.g., an elastic band) passing over the base of the tongue1351the shaft1310serves to retract the base of the tongue1351. For example, one method for breathing disorder treatment includes positioning a first anchor member1330in the region of the first pharyngoglossal fold1357, positioning a second anchor member1330in the region of the second pharyngoglossal fold1357, and connecting a first end of a shaft1310at or near the first anchor member1330and connecting a second end of the shaft1310at or near the second anchor member1330. At least one of the first anchor member1330, the second anchor member1330and the shaft1310interact to distribute a force on at least a portion of a tongue1351that prevents obstruction of the patient's airway. A force is applied to the portion of the tongue1351the prevents the portion of the tongue1351from falling toward other tissues located in the oral cavity or pharynx. In this way, the patient's airway is maintained in the open position.

In some embodiments, the first anchor member1330comprises a first magnet, the first end of the shaft1310comprises a second magnet that attracts to the first magnet, the second anchor member1330comprises a third magnet, and the second end of the shaft1310comprises a fourth magnet that attracts to the third magnet.

In one embodiment, a first portion of a retractor member1320is inserted into the tongue1351, a second portion of the retractor member1320is exterior to the tongue1351, and at least a portion of the shaft1310contacts the second portion of the retractor member1320. At least one of the first anchor member1330, the second anchor member1330, the retractor member1320, and the shaft1310interact to distribute a force on at least a portion of the tongue1351to prevent obstruction of the patient's airway. In one embodiment, a portion of the shaft1310(e.g., a first end of the shaft1310) contacts, is coupled to, or presses upon a smaller retractor member1320that is semi-implanted in the tongue1351tissue. In one embodiment, at least a portion of the shaft1310is internal to the tongue1351.

Referring now toFIG. 13K, a first tissue retractor1301a(e.g., an LTR) is anchored beneath the tongue1351blade by a first anchor member1330a, a first shaft1310apasses through the tongue blade to a first retractor member1320a. The first retractor member1320aacts as a modified anchor member and provides a second anchor member1330bon the superior surface of the tongue1351. A second shaft1310bpasses posteriorly to a semi implanted second retractor member1320b. The semi implanted second retractor member1320bhas a first portion implanted in the tongue1351and a second portion exterior to the tongue1351. The use of a first tissue retractor1301aallows adjustment of tension of the second tissue retractor1301b. For example, the anchor site of the first anchor member1330alocated beneath the tongue blade1352can be adjusted such that the retraction force of the first retractor member1320ais altered. In this way, adjustment of the first anchor member1330aadjusts the second anchor member1330b. Thus, the force exerted by the second retractor member1320bby the second anchor member1330bis altered by adjusting the first anchor member1330a. More specifically, in one embodiment, the patient manipulates the second tissue retractor1301bby twisting the first tissue retractor1301ato pull slack from the shaft1310band thereby increase the force exerted by the semi implanted second retractor member1320b.

Referring now toFIG. 13L, a tissue retractor1301includes a shaft1310sized for insertion into a patient's tongue1351, a retractor member1320is connected at or near a first end of the shaft1310the retractor member1320is positioned at the external surface of the tongue1351and an anchor member1330is connected at or near a second end of the shaft1310. Referring also toFIG. 13M, a band1370is sized to surround at least a portion of the external diameter of the tongue1351and the band1370moves in the direction1379to exert a pressure on at least one of a portion of the retractor member1320and a portion of the shaft1310to prevent deformation of a portion of the tongue1351preventing deformation of a portion of a tongue1351avoids obstruction of the patient's airway. A force is applied to the portion of the tongue1351the prevents the portion of the tongue1351from falling toward other tissues located in the oral cavity or pharynx. In this way, the patient's airway is maintained in the open position. In some embodiments, the band1370is dimensioned to rotate and push at least one of a portion of the retractor member1320and a portion of the shaft1310.

In one embodiment, the tissue retractor1301is a rigid shaft1310that connects an anchor member1330below the tongue blade1352to a retractor member1320above the tongue blade1352. Referring now toFIG. 13M, a sleeve (e.g., a band1370) is reversibly placed over the tongue blade1352. The tissue retractor1301shown inFIG. 13Lis rotated forward by the band1370. More specifically, the retractor member1320and/or a portion of the shaft1310are rotated forward by the band1370when the band1370is reversibly placed over the tongue blade1352. The rotation of the retractor member1320, along with the rigid shaft1310, displaces the tissue of the tongue base1353along the midline. In some embodiments, the band1370rotates in the band direction1379shown inFIG. 13Mto displace the tissue of the tongue base1353such that the tissue of the tongue base1353does not fall toward the soft palate, the pharyngeal wall, and/or other tissues in the oral cavity or pharynx and the patient's airway is maintained in the open position.

In some embodiments, referring toFIGS. 13L-13M, a method for treatment of a breathing disorder includes inserting at least a portion of a shaft1310into a patient's tongue1351, connecting a retractor member1320at or near a first end of the shaft1310at an external surface of the tongue1351, and connecting an anchor member1330at or near a second end of the shaft1351. The method for treatment includes surrounding at least a portion of the external diameter of the tongue1351with a band1370disposed adjacent the retractor member1320and moving the band1370in, for example, the direction1379to exert a pressure on at least one of a portion of the retractor member1320and at least a portion of the shaft1310to prevent deformation of at least a portion of the tongue1351that prevents obstruction of the patient's airway. In some embodiments, moving the band1370comprises rotating the band1370and pushing at least a portion of the retractor member1320and at least a portion of the shaft1310to displace at least a portion of the tongue1351to prevent obstruction of the patient's airway. In this way at least a portion of the tongue1351does not fall toward other tissues in the oral cavity or pharynx (e.g., the soft palate and/or the pharyngeal wall) and the patient's airway is maintained in the open position.

Referring still toFIGS. 13L-13M, the tissue retractor1301is a common tongue ring (e.g., the retractor member1320is the tongue stud that sits on the top surface of the tongue1351). And the band1370sits adjacent the tongue stud and rotates the tongue ring (e.g., the tongue stud and a portion of the shaft of the tongue ring) to displace at least a portion of the tongue1351to prevent obstruction of the patient's airway. In some embodiments, the tissue retractor1301can be loaded, e.g., the band1370is placed adjacent to the tissue retractor1301when avoiding obstruction of the patient's airway is desired (e.g., at a time when the patient plans to sleep).

In other embodiments, referring toFIGS. 13K-13Land to the previously describedFIG. 9E, the retractor member1320(e.g., the tongue stud of a common tongue ring) is connected to a palatal prosthesis, one or more of the patient's teeth, or other dental anchor by, for example, a rubber band or a suture. Alternatively or in addition, the anchor member1330(e.g., the portion of a common tongue ring beneath the tongue) can be connected to a modified anchor (e.g., a dental anchor or an anchor in the frenulum area).

Referring now toFIGS. 14A-14E,15A-15F, and16A-16F, disclosed here are methods and devices for using the PGF as a retractor or anchor site in order to beneficially effect the tongue, pharyngeal walls and/or soft palate. On both sides of the tongue thin folds of mucosa connect the tongue to the mandible. These are called the pharyngoglossal folds (PGF). Within these folds are the palatoglossal, superior constrictor, styloglossus and hyoglossus muscles, from superior to inferior respectively. The PGFs separate the oral cavity (anterior) from the pharynx (posterior). Anterior to this PGF attachment there is no lateral connection of the tongue and it is freely mobile. One of the muscles within the PGF is the palatoglossus which courses superiorly to connect with the soft palate, thereby forming what is seen in mouth as the anterior tonsillar pillar.

Unexpectedly, the PGF has been found to have several advantages as a retraction site that enlarges the pharyngeal airspace. The connective tissue of the PGF is connected with the connective tissue of the tongue. Therefore, it has been unexpectedly found that traction on the PGF is transmitted to the base of tongue. Moreover, as the superior pharyngeal constrictor and palatoglossus muscles are attached to the PGF and in turn connect with the lateral pharyngeal walls and soft palate these structures, the superior pharyngeal constrictor and palatoglossus muscles, can also be retracted (FIG. 14). In particular, a preferred site within PGF is its superior end, at the superior end many of these muscles (e.g., the superior pharyngeal constrictor, palatoglossus muscles, the lateral pharyngeal walls, and the soft palate) overlap as they insert into the tongue. Therefore, retraction at one site expands the pharyngeal airway by simultaneously stiffening and/or retracting the tongue base, lateral pharyngeal walls and soft palate. This combined effect of an expanded pharyngeal airway has a beneficial effect on sleep disordered breathing.

A further advantage of the PGF is that it is easily accessible to both the physician and patient. The PGF is not normally seen during examination of the mouth as it is in a folded state and hidden by the tongue surface that sits above the PGF. However, the PGF can be easily palpated by sliding a finger along the floor of the mouth next to the mandible, at the level of the edge of the mandible a smooth vertical wall is reached which blocks entry into the pharynx, this smooth vertical wall is the PGF. To visualize the PGF the tongue can be retracted medially with a tongue blade.

A further advantage of the PGF is that the PGF does not have a lot of sensory innervation. The area of the mouth around the PGF is highly sensitive. Specifically, the tonsillar pillars (discussed in greater detail in association withFIG. 17) and the tongue surface next to the PGF are particularly sensitive areas of the upper airway that can cause reflex gagging. However, it has unexpectedly been found that touching the PGF itself causes little or no reflex gagging. Moreover, where there is any sensation (e.g., even a small amount of sensation) caused by contacting or touching the PGF, when a device is placed in the region of the PGF and contacts the PGF for a period of time any sensation disappears within minutes of the device contacting the PGF.

A further advantage of the PGF is that it is thin and easy to puncture yet contains enough connective tissue to provide a firm interface with all or a portion of a tissue retractor (e.g., a retractor member, a shaft, and an anchor member). Anatomical studies by the inventor have shown that the PGF has few neurovascular structures. The PGF has a thickness that ranges from about 1 mm to about 3 mm. Therefore contacting, piercing, or puncturing the PGF is generally safe and there is little risk of damage to the PGF, due to the PGF thickness. The tissue in the PGF has only a minor amount of blood vessels and nerves.

In some embodiments, a tissue retractor (e.g., an LTR) is used to displace the PGF and/or tissue in the region of (e.g., neighboring) the PGF. In some embodiments, retraction of the PFG is in an anterior direction such that anterior retraction of the PGF displaces the entire base of the tongue anteriorly thereby increasing the patients retroglossal and retropalatal airspace.FIG. 15Ashows an obstructed airway andFIGS. 15B-15Fshow anterior retraction of the tongue base due to PGF retraction. In some embodiments, inferior retraction of the PGF displaces the tongue base inferiorly thereby removing tissue volume from the retropalatal area, the narrowest part of the upper airway. Thus inferior retraction increases the retropalatal airspace, which is desirable for treatment of breathing disorders such as, for example, sleep apnea. In another embodiment, lateral retraction of the PGF would stiffen and flatten the posterior surface region of the tongue base. A flatter posterior surface region of the tongue base may improve the available airspace in the patient's upper airway and therefore be desirable for breathing disorder treatment. Without being bound to any theory, it is believed that one or more of anterior retraction, interior retraction, and lateral retraction of the PGF are more effective for breathing disorder treatment than are posterior retraction or medial retraction of the PGF.

Retraction of the PGF may be in a single direction or in multiple directions (e.g., retraction of the PGF may be unilateral or bilateral). For example, in one embodiment the PGF on one side of a patient's mouth (e.g., the first side) is subject to anterior retraction by a first tissue retractor and the PGF on the other side of the patient's mouth (e.g., the second side) is subject to anterior retraction by a second tissue retractor. Methods of PGF retraction could be acute, just during an obstructive episode, or semi acute, while sleeping (e.g., overnight), or for extended durations. Extended durations of PGF retraction would likely cause tissue remodeling that would cause the patient's tongue to tend to remain in a more anterior position such that when the tissue retractor is removed from the PGF and no force is being applied to the PGF the tissue remodeled tongue remains positioned in a more anterior position than its location prior to being subject to PGF retraction.

FIGS. 15A-15Fdepict the PGF1557and embodiments of PGF1557retraction.FIG. 15Ashows the posterior collapse of the tongue1551whereby the tongue base1553collapses toward the pharyngeal wall1565and/or the soft palate1566to reduce size of the patient's airway. Some patient's having breathing disorders including snoring and sleep apnea suffer from a reduction of available patient airway to airflow1569as depicted byFIG. 15A. Airway airflow1569reduction caused by the posterior collapse of the tongue1551can actually obstruct a portion of the airway or can create the sensation to the patient that the reduced size airway is obstructed to airflow1569. In accordance with some embodiment's of breathing disorder treatment, devices and methods are employed to improve the patient's airway in a manner that prevents obstruction (e.g., prevents actual obstruction and/or prevents an airway size reduction that produces the sensation in the patient that the airway is obstructed to airflow1569).

Referring now toFIG. 15B, in one embodiment, a retractor member1520is positioned at or near the PGF1557(i.e., the first PGF), a shaft1510connects to the retractor member1520and passes across the frenulum1560(i.e., on the external surface of the frenulum1560) to attach to a similarly positioned retractor member1520positioned at or near the PGF on the opposite side of the patient's oral cavity (i.e., the second PGF). More specifically, in some embodiments, a retractor member1520is adjacent the PGF1557(i.e., the first PGF) and a portion of the shaft1510is inserted into the PGF1557, another portion of shaft1510passes across the frenulum1560, the shaft1510enters the other PGF (i.e., the second PGF) and another retractor member is adjacent the second PGF. The two PGF's are moved in the retraction direction1513. Movement of the two PGF's in the retraction direction1513opens up the patient's airway to airflow1569by, for example, moving the tongue base1553in the retraction direction1513rather than toward the pharyngeal wall1565and/or toward the soft palate1566.

Referring now toFIG. 15C, a retractor member1520is about or in the PGF1557and a shaft1510passes through the tongue1551tissue to emerge and connect to a modified anchor1531. The modified anchor1531may be a dental appliance or a tooth, for example. In one embodiment the retractor member1520lays against the PGF1557, a portion of the shaft1510passes through the PGF and another portion of the shaft1510passes through the tongue1551to the modified anchor1531located adjacent the frenulum and/or in the region of the mandible. Movement of the PGF1557in the retraction direction1513opens up the patient's airway to airflow1569by, for example, moving the tongue base1553in the retraction direction1513rather than toward the pharyngeal wall1565and/or toward the soft palate1566.

Referring still toFIG. 15Can alternative embodiment is also depicted showing that the retractor member1520in the PGF1557passes through the tongue1551tissue through the floor of the mouth to an external anchor1532resting on the patient's skin1590, e.g., against the patient's chin. In one embodiment, the retractor member1520lays against the PGF1557, a portion of the shaft1510passes through the PGF1557and another portion of the shaft1510passes through the tongue1551to the external anchor1532resting external to the oral cavity on the patient's skin1590. The tissue retractor1501opens up the patient's airway to airflow1569by, for example, moving the tongue base1553in the retraction direction1513rather than toward the pharyngeal wall1565and/or toward the soft palate1566.

In one embodiment, referring now toFIG. 15D, an implanted tissue retractor1501has a retractor member1520implanted within the PGF1557(or in neighboring tongue1551tissue) and a shaft1510passes through the tongue1551and passes anteriorly and inferiorly to an implanted anchor in the tongue1551, an implanted anchor in the genioglossus muscle, and/or an implanted anchor in structures located in or at the floor of mouth. The tissue retractor1501opens up the patient's airway to airflow1569by moving the PGF1557in the retraction direction1513, which moves the tongue base1553away from the pharyngeal wall1565and/or the soft palate1566.

Referring now toFIG. 15E, in one embodiment the retractor member1520is implanted against the superior PGF1557aand the shaft1510passes inferiorly through or outside the PGF1557to an anchor member1530that is implanted against the same PGF1557either on the same side or on the opposite side of the retractor member1520. Referring still toFIG. 15E, the tissue retractor1501includes a retractor member1520in the superior PGF1557a, a shaft1510passing through or outside the PGF1557, and an anchor member1530in the inferior PGF1557b. This method retracts the superior PGF1557ain an inferior direction, namely, in the retraction direction1513, which opens up and prevents obstruction of the patient's airway to airflow1569. Retraction of the PGF1557avoids soft tissue movement toward the pharyngeal wall1565and/or the soft palate1566.

In a further embodiment, referring now toFIG. 15F, the retractor member1520sits against the PGF1557, a portion of the shaft1510passes through the PGF1557and another portion of the shaft1510passes through the tongue1551medially and superiorly to an anchor member1530on the superior surface of the tongue1551. In some embodiments, the anchor member1530is the tongue stud of a common non-medical tongue piercing and one end of the shaft couples to the anchor member1530(i.e., the tongue stud). For example, in some embodiments, an end of the shaft1510contains a material that attracts to the tongue stud such as, for example, a magnet that attracts to the tongue stud. In other embodiments, an end of the shaft1510has a hook or a loop that couples with all or a portion of the anchor member1530(e.g., a tongue stud). This movement of the PGF1557by the tissue retractor avoids movement of the tongue base1553toward the pharyngeal wall1565and/or the soft palate1566. In this way, the airway airflow1569is maintained open and free from obstruction (or the sensation of obstruction).

In some embodiments, referring toFIG. 16A, a retractor member1620is disposed in the tongue base1653. An anchor member1630is disposed in each PGF1657. For example, in one embodiment, an anchor member1630is disposed in the anterior (i.e., the front) of each PGF1657. A shaft1610connects each anchor member1630to the retractor member1620such that a first shaft1610is disposed between the anchor member1630disposed in the first PGF1657and the retractor member1620and a second shaft1610is disposed between the anchor member1630disposed in the second PGF and the retractor member1620. The first shaft1610and the second shaft1510may be inside the tongue1651, i.e., they may be sub-mucosal. In some embodiments, there is a single shaft1610with a first end connected to the first anchor member1630, a second end connected to the second anchor member1630, and a portion of the shaft1610contacts the retractor member1620. The single shaft1610may be sub-mucosal or, alternatively, it may be on the exterior surface of the tongue1651. In another embodiment, the retractor member1620is implanted at the tongue base1653and connects to two shafts1610, one shaft1610is placed at the first PGF1657and the other shaft1610is placed at the second PGF1657.

In some embodiments, referring toFIG. 16B, an anchor member1630is disposed in each PGF1657. For example, in one embodiment, an anchor member1630is disposed in the anterior (i.e., the front) of each PGF1657. A single shaft1610connects to each anchor member1630such that a first end of the shaft1610connects to an anchor member1630disposed in the first PGF1657and the second end of the shaft1610connects to an anchor member1630disposed in the second PGF1657. At least a portion of the shaft1610is disposed substantially adjacent the base1653of the tongue1651and the shaft1610can be exterior to the tongue1651. Alternatively, all or a portion of the shaft1610may be inside the tongue1651, i.e., it may be sub-mucosal.

In some embodiments, referring now toFIG. 16C, an anchor member1630is implanted in or near each PGF1657. A single shaft1610connects to each anchor member1630such that a first end of the shaft1610connects to an anchor member1630disposed in or near the first PGF1657and the second end of the shaft1610connects to an anchor member1630disposed in or near the second PGF1657. At least a portion of the shaft1610is disposed substantially adjacent the base1653of the tongue1651and the shaft1610can be exterior to the tongue1651. Alternatively, all or a portion of the shaft1610may be inside the tongue1651, i.e., it may be sub-mucosal. In one embodiment, the two anchor members1630are each anterior to the two PGF's1657.

In a further embodiment, referring now toFIG. 16D, an anchor member1630is implanted in or near each PGF1657and each anchor member1630is a magnet1691or other nonferrous material. A single shaft1610connects to each anchor member1630such that a first end of the shaft1610connects to an anchor member1630disposed in or near the first PGF1657and the second end of the shaft1610connects to an anchor member1630disposed in or near the second PGF1657. In one embodiment each end of the shaft1610includes a magnet or other material that has a polarity opposite to the polarity of the anchor member1630implanted at or near the PGF's. At least a portion of the shaft1610is disposed substantially adjacent the base1653of the tongue1651and the shaft1610can be exterior to the tongue1651. Alternatively, all or a portion of the shaft1610may be inside the tongue1651, i.e., it may be sub-mucosal. In one embodiment, the two anchor members1630are each anterior to the two PGF's1657. In some embodiments, external structures having a polarity opposite the implanted anchor members1630(e.g., the magnets1691) are employed to bond the implanted anchor member1630sto the external structures. For example, a dental appliance or insert such as a mouth guard can contain a region that attracts to the implanted anchor members1630and that moves the PGF1657or the region of the PGF1657in a desired direction. Such methods move the PGF1657in the retraction direction1613, which opens up and prevents obstruction of the patient's airway. A patient can use the dental appliance at night to alleviate symptoms associated with breathing disorders including, for example, sleep apnea.

Referring now toFIG. 16E(two figures on the left), in some embodiments, a retractor member1620can be implanted in the PGF1657. The retractor member1620can be a magnet1691implanted in a PGF1657that is retracted by a magnet1691or other material of opposite polarity. The magnet1691of opposite polarity can be attached to a modified anchor, for example. A variety of coupling mechanisms could be used to retain the retractor member1620magnet1691within the PGF1657.

Referring now toFIG. 16E(two figures on the right) a retractor member1620can be an implanted magnet1691enclosed that has two flanges to keep the magnet1691in place within the PGF1657. For example, the retractor member1620can have a flange surface near its posterior aspect that would provide the interface against the PGF1657to cause anterior retraction of the PGF1657. The flange surface can have a rim that forms an edge around a portion of the PGF1657that is being retracted.

In another embodiment, the retractor member1620has a first flange with an exterior edge and an interior shaft, the interior shaft can have a first conduit. The second flange can likewise have an exterior edge and an interior shaft having a second conduit. When the retractor member1620is implanted in the PGF1657the first flange is adjacent the posterior aspect and the interior shaft pierces the PGF to provide a first conduit that flows through the PGF1657the second flange interior shaft mates with first flange interior shaft and the second flange is adjacent the anterior aspect. Thus the first conduit and the second conduit of the retractor member1620cut through the PGF1657and provide a single conduit through the PGF1657.

Referring toFIG. 16E(the two figures on the left and the two figures on the right) where magnets1691are implanted within each PGF1657external modified anchors with magnets or other materials of opposite polarity may be used to bond to the implanted magnets1691and to anchor them to external structures. Suitable external modified anchors can include, for example, a dental appliance or insert such as a mouth guard that has a region that attracts to the implanted magnets1691. This embodiment is minimally invasive and allows the patient a very high degree of comfort during the day when the implant is unconnected and therefore unloaded (e.g., when the modified anchor is not inserted in the patient's mouth). Suitable modified anchors can include various shaft and anchor combinations. A variety of external modified anchors can be tested without needing to replace the retractor member implant (e.g., the magnet1691).

In some embodiments, a tissue retractor1601is employed in the region of the PGF1657such that the anchor member1630of the tissue retractor1601is coupled to a dental anchor (e.g., the anchor member1630is coupled to the patient's tooth1698or other dental structure in the patient's mouth). The anchor member1630could be a full loop, a partial loop, or a hook that anchors to the tooth1698or to a palatal prosthesis. The tissue retractor1601retractor member1620couples to the PGF1657using magnets or other mechanical mechanisms known in the art. In some embodiments, the dental anchor is employed to retract the PGF1657. An advantage of this device is that the PGF1657is very close to the mandibular teeth and a secure but reversible loading of the implanted tissue retractor1601between the PGF1657and the teeth1698can therefore be achieved with short devices. Moreover, due in part to the relatively short route from the PGF1657to the molar teeth1698the tissue retractor1601is unlikely to cause the patient significant discomfort.

FIG. 16F(on the left) shows a schematic of a tissue retractor1601having an anchor member1630that aligns with a dental type modified anchor. The anchor member1630reversibly attaches to teeth1698as shown on right. A shaft1610of variable length attaches to a retractor member1620(e.g., a coupling mechanism) that in turn connects to an implant in the mouth. The implant can be a magnet that is positioned at or near the PGF1657. For example, the retractor member1620may be a magnet or a mechanical mechanism.FIG. 16F(on the right) depicts a drawing of a tongue and a mandible as seen from above.

FIG. 16F(on the right) shows a tissue retractor1601ahaving a magnet implanted at or near the PGF1657the implanted magnet is attracted to an end of the shaft1610that is coupled to a retractor member1630that surrounds the patient's tooth1698. In one embodiment, the end of the shaft1610has a magnet that is attracted to the magnet implanted at or near the PGF1657.FIG. 16F(on the right) also shows the tissue retractor1601bthat acts to mechanically hook the PGF1657, which is described in greater detail inFIG. 21Hin association with the tissue retractor2101. Referring now toFIGS. 16A-16Fforces on the retractor member1620, anchor member1630, and/or shaft1610improve the patient's airway in a manner that prevents obstruction (e.g., prevents actual obstruction and/or prevents an airway size reduction that produces the sensation in the patient that the airway is obstructed to airflow). In some embodiments, the PGF1657is moved in a direction that opens up the patient's airway and prevents obstruction of the patient's airway to airflow. In some embodiments, soft tissue movement toward the pharyngeal wall and/or the soft palate is avoided. In other embodiments, the tongue base1653is moved in a direction away from the pharyngeal wall and/or the soft palate.

All of a portion of the tissue retractors described herein may be coupled to structures such as, for example, the PGF, the area lateral to the PGF, the styloglossus, hyoglossus, chondroglossus, pharyngeal constrictor, levator and tensor of the palate, masetter, temporalis, pterygoid, facial, and platysma muscles; the hyoid, mandible, facial, and vertebral bones; the thyroid, cricoid, epiglottic cartilages; the stylohyoid, ptyrogomandibular ligaments, and other fascial structures.

8. Soft Palate and Tonsillar Folds

Disclosed here are methods and devices for retracting the lateral pharyngeal walls and soft palate.FIGS. 17A-17Cshow the basic anatomy of the internal soft palate structures and some embodiments employing tissue retractors to retract portions of the soft palate. The soft palate is a thin muscular structure that separates the nasopharynx and velopharynx from the oral cavity. It begins at the edge of the hard palate and extends downward toward the throat. In the midline it ends at the uvula, and on each side it divides into two folds that surround the palatine tonsils: the anterior tonsillar fold, also called the palatoglossal fold, inserts into the side of the tongue near the superior PGF; the posterior tonsillar fold, also called the palatopharyngeal fold, inserts into the lateral pharyngeal wall.

Excess length or thickness of the soft palate decrease the volume of the velopharynx and contribute to snoring and sleep apnea. In addition, laxity of the soft palate and laxity of the pharyngeal walls predisposes a patient's airway to airway collapse. Tissue retractors and methods employing tissue retractors can reversibly or persistently thin, stiffen, and/or retract the soft palate and pharyngeal wall structure to avoid obstruction of the patient's airway.

Tissue retractors can be employed in a portion of the soft palate in a manner similar to tissue retractor placement in the tongue or the PGF, for example. In accordance with one tissue retraction method, an anchor member is disposed external the PGF, a shaft is disposed through the PGF and through the soft palate, and the retractor is on an external surface of the soft palate. Specifically, a tissue retractor placed in the soft palate could rest in place unloaded with a minimum tension (e.g., from about 1 gm to about 100 gm, or from about 5 gm to about 15 gm) that is sufficient to keep the shaft within the soft palate tissue with the anchor member and/or retractor member resting against the mucosa (e.g., against the external surface of the soft palate). The patient would therefore have little or no sensation of the presence of the tissue retractor. During the time for sleep (e.g., at night) the tissue retractor could be “loaded” (e.g., the tension exerted on the tissue retractor could be increased to from about 1 gm to about 1000 gm, or from about 5 gm to about 100 gm). In some embodiments, the tissue retractor is loaded by placing a modified anchor (e.g., a bolster) between the anchor and the mucosa. In other embodiments, the tissue retractor is loaded when it is connected to a dental anchor (e.g., a dental device like a retainer or mouth guard, a tooth, or a dental implant). The exact site and orientation of the lateral tissue retractor has a great influence on whether the effects of the tissue retractor are primarily to compress or to displace tissue.

FIGS. 17A-17Cshow different views of four exemplary tissue retractor positions where each of the four tissue retractors has an anchor member1730positioned in the same anchor site, at the superior PGF. The remaining portions of each of the four tissue retractors (i.e., the shaft and retractor member) has a different placement position and each of the four tissue retractor has a different beneficial effect. Generally, at least a portion of the shaft is disposed inside the tissue of the soft palate.

FIG. 17Ais a view of the mouth showing the soft palate and palatoglossal folds.FIG. 17Bis the same view asFIG. 17A, but with mucosa removed showing the underlying muscles (right side) and the nerve and blood supply (left side).FIG. 17Cshow the view of the left lateral pharyngeal wall area after mid-sagittal section ofFIG. 17Band the tongue is retracted inferiorly. Four positions for placement of tissue retractors are shown, in each of the four positions an anchor member1730is positioned in the superior PGF. In position 1 the shaft passes next to palatoglossus muscle around the tonsil, the retractor rest against lateral edge of soft palate. This embodiment increases the lateral velopharyngeal area. Position 1 is oriented to achieve inferior displacement of the lateral aspect of the soft palate, thereby enlarging the velopharynx.

In position 2 the shaft travels within the palatoglossus muscle, the retractor is near the midline soft palate. This embodiment increases medial velopharyngeal airspace. In position the tissue retractor passes to the midline of the soft palate. The exact location, force and number of tissue retractors can be varied in order to best treat the specific pathology of each patient

In position 3 the shaft passes through the palatoglossus muscle, the palatine tonsil, and the palatopharyngeus muscle, the retractor rests against the posterior wall of the soft palate. This embodiment compresses and permanently remodels the palatine tonsil. In position 3 the tissue retractor passes across the tonsil to a retractor on the pharyngeal side of the posterior tonsillar pillar. The tonsils in sleep apnea patients often are enlarged relative to the tonsils in individuals who do not suffer from sleep apnea and this enlargement contributes to the excess soft tissue of the upper airway. Tension in the shaft would compress and the tonsils and decrease their volume.

In position 4 the shaft passes 1 cm under the tongue base mucosa and the retractor rests against tongue base. This position of tissue retractor placement can be employed for tensing the tongue base. In position 4 the tissue retractor passes from the superior PGF to the mucosa of the tongue base. This embodiment stiffens the mucosa of the tongue base and prevents the tongue base from deforming backward.

Referring now toFIGS. 15-17, a method for treatment of a breathing disorder includes positioning a shaft having a first end and a second end in a patient's oral cavity or pharynx and connecting one of a retractor member and an anchor member at or near the first end and in the region of the pharyngoglossal fold. The other of the retractor member and the anchor member is connected at or near the second end of the shaft. At least one of the shaft, the retractor member, and the anchor member interact to distribute a force on at least one of a tongue base, a lateral paryngeal wall, a tonsillar fold, or a soft palate and the force prevents obstruction of the patient's airway. Optionally at least a portion of the retractor member or at least a portion of the anchor member is positioned: on an external surface of the pharyngoglossal fold or behind the pharyngoglossal fold. In one embodiment, at least a portion of the retractor member or at least a portion of the anchor member is disposed inside the region of the pharyngoglossal fold. In some embodiments, the first end of the shaft comprises a first magnet and one of the retractor member and the anchor member comprises a second magnet or a ferrous material that attracts to the first magnet. In some embodiments, the retractor member is in the region of the pharyngoglossal fold and the anchor member couples to a tooth. In some embodiments, at least a portion of the shaft is internal to at least one of the pharyngoglossal fold and a tongue. Optionally, at least a portion of the anchor member or at least a portion of the retractor member is positioned inside the patient's mouth, in the region of the patient's frenulum, external to the patient's mouth, adjacent a surface of a tongue, inside a tongue, or external to a soft palate.

Referring still toFIGS. 15-17, a tissue retractor for treatment of a breathing disorder can include a retractor member having a first magnet, a shaft sized for placement in a patient's oral cavity or pharynx with a first end of the shaft having a second magnet or other material that attracts to the first magnet, and an anchor member connected at or near the second end of the shaft. At least one of the shaft, the retractor member and the anchor member interact to distribute a force on a soft tissue in the patient's oral cavity or pharynx, and the force prevents obstruction of the patient's airway. The anchor member can couple to a tooth, for example, the anchor member can surround at least a portion of the tooth.

FIGS. 18A-18Fshow a variety of methods for treatment of a breathing disorder employing a tissue retractor1801in the tonsillar folds. Referring toFIG. 18A, a tissue retractor1801includes a retractor member1820connected to a first end of a shaft1810and an anchor member1830connected to a second end of the shaft1810. The retractor member1820is on the posterior surface of posterior tonsillar fold, at least a portion of the shaft1810is inside the tissue of the soft palate, and the anchor member1830is positioned on the anterior surface of anterior tonsillar fold. The tissue retractor1801placement shown inFIG. 18Acompresses the palatine tonsil. Referring now toFIG. 18B, the retractor member1820is in the superior Palatoglossus fold an anchor member1830is in the inferior Palatoglossus Fold or PGF. A shaft1810connects the retractor member1820to the anchor member1830.

Referring now toFIG. 18C, the tissue retractor1801is implanted within the palatoglossus muscle, this fully implanted tissue retractor1801including an anchor member and a retractor member connected by a shaft is implanted in non tongue tissue for treatment of breathing disorders. In one embodiment, the inferior end of the tissue retractor1801is the anchor member and the superior end of the tissue retractor1801is the retractor member. Referring now toFIG. 18D, the anchor member1830is positioned at the lateral portion of the soft palate, at least a portion of the shaft1810is positioned inside the tissue of the soft palate, and the retractor member1820is positioned at the midline of the soft palate. Referring now toFIG. 18E, the tissue retractor1801has a retractor member1820on the inner surface of the palatoglossal fold and the tissue retractors anchor member1830is a modified dental anchor that couples to a patient's tooth1898. In one embodiment, the anchor member1830surrounds a portion of the patient's tooth1898. For example, the anchor member1830can have the shape of a hook that surrounds only a portion of the patient's tooth1898. All or a portion of the shaft1810may be inside the soft palate tissue. Alternatively, both the shaft1810and the anchor member1830are external to the soft palate tissue. Referring now toFIG. 18F, the tissue retractor1801has a retractor member1820that is located posterior to the tonsillar fold, at least a portion of the shaft1810is inside the tissue of the soft palate, and the anchor member1830is anterior the tonsillar fold. The tongue, the lateral pharyngeal walls, and the soft palate can alone or in combination contribute to obstructions related to breathing disorders such as sleep apnea. More specifically, the lateral pharyngeal walls and the soft palate contribute extra soft tissue that decreases the volume of the velopharyngeal airspace. In patients that suffer from breathing disorders such as obstructive sleep apnea the lateral pharyngeal walls and the soft palate can become flaccid. Suitable tissue retractors can be employed to retract and/or tighten the soft tissue in the lateral pharyngeal walls and the soft palate thereby enabling patentcy of the patient's airway. In some embodiments, all or a portion of the patient's tonsils are compressed, thereby directly decreasing the volume of the patients tissue by, for example, tissue remodeling.

Referring now toFIGS. 18A-18F, a method for treatment of a breathing disorder includes implanting into a tonsillar fold in a patient's oral cavity or pharynx a shaft1810with a retractor member1820connected at a first end and an anchor member1830connected at a second end. At least one of the shaft1810, the retractor member1820, and the anchor member1830interact to distribute a force on a soft tissue in the patient's oral cavity or pharynx. The force exerted on the soft tissue prevents obstruction of the patient's airway.

Referring still toFIGS. 18A-18F, a method for treatment of a breathing disorder includes implanting at least a portion of a shaft1810having a first end and a second end into a tonsillar fold in a patient's oral cavity or pharynx. One of a retractor member1820and an anchor member1830is connected at or near the first end of the shaft1810and the other of the retractor member1820and the anchor member1830are connected at or near the second end of the shaft1810. At least one of the retractor member1820and the anchor member1830is external to the tonsillar fold and at least one of the shaft1810, the retractor member1820, and the anchor member1830interact to distribute a force that prevents obstruction of the patient's airway. In one embodiment, the force pushes at least a portion of the soft palate to open at least a portion of the patient's airway. In some embodiments, the anchor member1830surrounds at least a portion of the patient's tooth1898. In some embodiments, the anchor member1830is external to an anterior tonsillar fold.

FIGS. 19A-19Fshow embodiments for treatment of a breathing disorder in which a tissue retractor1901is disposed in a patient's soft palate1966.FIG. 19Ashows an embodiment of a midline tissue retractor1901disposed in the soft palate1966with an anchor member1930disposed on the pharyngeal side19661near the hard palate. The shaft1910passes through soft tissue of the soft palate1966, and the retractor member1920head is in the uvular area (FIG. 18D). The retractor member1920is disposed on the oral side19662of the soft palate1966. In one embodiment, the anchor member1930is disposed on the superior pharyngeal side19661and the retractor member1920is on the inferior oral side19662. The retractor member1920can be inserted so that it faces any of the forward, downward or backward direction. The anchor member1920can rest against the mucosa on the pharyngeal side19661. The anchor member1930can be available to couple to a modified anchor on the pharyngeal side19661of the soft palate1966. The modified anchor can be, for example, an implant disposed in the pharyngeal wall.

FIG. 19Bshows a tissue retractor1901disposed in the soft palate1966with an anchor member1930disposed on the inferior pharyngeal side19661, the shaft1910passes through soft tissue of the soft palate1966, and the retractor member1920is disposed on the superior oral side19662of the soft palate1966. The retractor member1920could be inserted so it faces either forward, downward or backward. Optionally, the anchor member1930could rest against the mucosa on either the oral side19662or the pharyngeal side19661. The anchor member1930would be available to couple to a modified anchor such as a dental appliance on the oral side19662or a modified anchor on the pharyngeal side19661.

FIG. 19Cshows the effect of a modified anchor on the shape and position of the soft palate1966. The modified anchor can be used in conjunction with a tissue retractor1901. In one embodiment, the modified anchor is a bolster1940. The tissue retractor1901is disposed in a patient's soft palate1966such that a shaft1910passes through the soft tissue of the soft palate1966, the retractor member1920is connected at or near a first end of the shaft1910and the anchor member1930is connected at or near a second end of the shaft1910. At least one of the anchor member1930and the retractor member1920is disposed on an external surface of the soft palate1966. The bolster1940is, in one embodiment, disposed between the external surface of the patient's soft palate1966and the anchor member1930. In one embodiment, the bolster1940has a recess in its surface that is designed to allow the anchor member1930head to fit into the bolster1940recess, such that after insertion the combined anchor member1930and bolster1940presents a smooth and soft continuous surface. The surface of the combination bolster1940and anchor member1930avoids effect on speech and/or swallowing and causes minimal discomfort to the patient. The bolster1940rotates, stiffens, and indents the soft palate1966all of which serves to decrease the patient's susceptibility to snoring and airway obstruction. The amount of tension added by the bolster1940ranges from about 1 gm to about 500 gms, from about 5 gms to about 250 gms, or from about 10 gms to about 50 gms. Additional of the bolster1940to the tissue retractor1901can, in one embodiment, “load” the tissue retractor1901so that the “loaded” tissue retractor1901prevents obstruction of the patient's airway.

FIG. 19Dshows another embodiment of a tissue retractor1901disposed in the patient's soft palate1966. The tissue retractor1901is implanted in the patient's soft palate1966. The tissue retractor1901includes a shaft with a retractor member connected at or near a first end and an anchor member connected at or near a second end. In one embodiment of the implanted tissue retractor1901the anchor member is superior to the retractor member. In another embodiment of the implanted tissue retractor1901, the retractor member is superior to the anchor member.

FIG. 19Eshows an embodiment of a tissue retractor1901where the anchor member and the retractor member are both disposed on the external surface of the soft palate1966and each of the anchor member and the retractor member are aligned on either side of the soft palate1966(i.e., the retractor member opposes the anchor member and the shaft is disposed through the soft tissue of the soft palate1966). In one embodiment, the aligned anchor member and retractor member of the tissue retractor1901are employed to compress a thickened soft palate1966. Each of the anchor member and the retractor member of the tissue retractor1901provide tension along the tissue retractor1901shaft that compresses and thins the soft palate1966tissue that lies between the anchor member and the retractor member.

FIG. 19F, shows an embodiment of a tissue retractor1901where the anchor member and the retractor member are both disposed on the external surface of the soft palate1966and each of the anchor member and the retractor member are aligned on either side of the soft palate1966(i.e., the retractor member opposes the anchor member and the shaft is disposed through the soft tissue of the soft palate1966). One or more band1970is adjacent the external surface of the soft palate1966, for example, the band(s)1970are adjacent the edge of the soft palate1966with a first end of the band1970substantially adjacent the anchor member and a second end of the band1970substantially adjacent the retractor member of the tissue retractor1901. For example, in one embodiment, the first end of the band1970is disposed between the anchor member and the external surface of the soft palate1966, optionally, a portion of the shaft external to the soft tissue is placed through an aperture disposed in the first end of the band1970. Likewise, the second end of the band1970is disposed between the retractor member and the external surface of the soft palate1966and another portion of the shaft external to the soft tissue is placed through an aperture disposed in the second end of the band1970. Alternatively, each end of the band1970is held between the anchor member and the soft tissue and the retractor member and the soft tissue by compressive force.

Referring toFIGS. 19A-19F, a method for treatment of a breathing disorder includes inserting a shaft1910into a soft palate1966located in a patient's oral cavity or pharynx, connecting a retractor member1920at or near a first end of the shaft1910, and connecting an anchor member1930at or near a second end of the shaft1910. At least one of the shaft1910, the retractor member1920, and the anchor member1930interact to exert a pressure that prevents deformation of a portion of the soft palate1966to prevent obstruction of the patient's airway. In one embodiment, at least one of the retractor member1920or the anchor member1930is on an external surface of the soft palate1966. In some embodiments, the method employs a band1970, a first end of the band connects at or near the retractor member1920, a second end of the band1970connects at or near the anchor member1930, and the band1970externally surrounds at least a portion of the soft palate1966. At least one of the shaft1910, the retractor member1920, the anchor member1930, and the band1970interact to exert a pressure that prevents deformation of a portion of the soft palate1966to prevent obstruction of the patient's airway. The pressure that prevents deformation of a portion of the soft palate1966avoids the tissue of the soft palate from moving toward regions of soft tissue within the patient's oral cavity or pharynx, for example, a portion of the tissue of the soft palate1966does not move toward the patient's tongue. The portion of the soft palate1966is retrained from being displaced and deformed to restrict and/or close the patient's airway. Optionally, the method includes disposing a bolster1940on an external surface of the soft palate1966between the external surface of the soft palate1966and one of the retractor member1920and the anchor member1930.

Referring still toFIGS. 19A-19F, a tissue retractor1901for treatment of at least one of snoring and sleep apnea includes a shaft1910sized for insertion into a patient's soft tissue, a retractor member1920connected at or near a first end of the shaft1910, the retractor member1920positioned on an external surface of the patient's soft tissue, an anchor member1930connected at or near a second end of the shaft1910, and a band1970. The band1970is sized to surround at least a portion of the external diameter of the patient's soft tissue, a first end of the band1970is connected at or near the retractor member1920, and a second end of the band1970is connected at or near the anchor member1930. At least one of the shaft1910, the retractor member1920, the anchor member1930, and the band1970interact to exert a pressure that prevents deformation of a portion of the soft tissue to prevent obstruction of the patient's airway. In one embodiment of the tissue retractor1901, the anchor member1930is positioned on an external surface of the patient's soft tissue.

Referring now toFIGS. 20A-20Gdisclosed here are methods and devices to treat sleep apnea and related disorders in mammals such as, for example, horses. A non-limiting example of an non-human upper airway disorder is dorsal displacement of the soft palate (DDSP) in horses. Race horses are superb animal athletes that place the greatest demands on respiration. All non-human mammals have a different configuration of their upper airways.FIG. 20Ashows the normal configuration of the horse upper airway during exercise. The soft palate2066overlaps and interlocks the epiglottis2063of the larynx to provide an open conduit for airflow2069in the pharynx air space. Referring still toFIG. 20A, specifically the soft palate2066and larynx are much closer and they usually interlock. Specifically, the soft palate2066is firmly held around the epiglottis2063of the larynx so that the airway flow from the nose through the posterior pharyngeal wall2071and into the lungs is protected and secure. In race horses this is of special importance because of the tremendous volume of air that must smoothly flow into and out of the lungs with each breath during exercise.

Referring now toFIG. 20B, in some horses this interlocking of the soft palate2066and epiglottis2063breaks down and the soft palate2066passes backward over the epiglottis2063. In DDSP the soft palate2066is dislodged from its locked position and obstructs the airway to airflow2069. This displacement of the soft palate2066immediately interferes with breathing and then the animal stops running. Although the cause of DDSP is not known with certainty, many trainers believe that the tongue2051causes the displacement by moving backward and pushing the soft palate2066out of position. The displacement is believed to be caused by the backward movement of the tongue base2053. For this reason many trainers actually tie the race horse's tongue2051forward prior to the race, a solution that is crude and uncomfortable for the animal.

Methods and devices are employed to prevent DDSP both by preventing backward displacement of the tongue2051and by securely coupling the soft palate2066to the epiglottis2063. In humans, the conditions surrounding sleep disordered breathing involve a relaxed tongue2051during sleep. In horses the situation is quite different: the tongue2051and other upper airway structures are much larger and are maximally active. Therefore, the tissue retractor2001(e.g., the LTR) must be adapted to these harsher conditions. Moreover, in horses secure prevention of backward movement of the tongue2051does not allow normal swallowing. Therefore it is necessary that the tissue retractor2001be used only when necessary to avoid upper airway obstruction (e.g., DDSP). For example, the tissue retractor2001can be loaded immediately before exercise and then unloaded immediately after exercise. Moreover the loading and unloading of the tissue retractor2001needs to be done by the trainer, with or without the cooperation of the horse.

Referring now toFIGS. 20C-20D, in some embodiments, a tissue retractor2001(e.g., an LTR) is used to prevent movement of the tongue2051backwards preventing backward movement of the tongue2051prevents dorsal displacement of the soft palate2066in a horse. The situation in the breathing disordered equine patient differs in many substantial ways from that of the breathing disordered human. In horses, the problem occurs when the animal is awake and exercising at its full capacity. It is believed that the tongue2051base2053moves backward and pushes the soft palate2066out of its normal position where it is interlocked with the epiglottis2063(this is shown inFIG. 20B). Therefore the tongue2051retracting forces needed in horses are much higher than the tongue retracting force used in humans. For example, the amount of force employed to retract the horses tongue2051ranges from about 1 gm to about 50 Kg, from about 10 gm to about 10 Kg, or from about 100 gm to about 1 Kg. To accommodate and/or exert these high forces the tissue retractor2001used in horses employs materials such as, for example, stainless steel or materials of comparable tensile strength to stainless steel.

In some embodiments, referring now toFIG. 20C, the tissue retractor2001spans from the tongue base2053through the mandible2068where the tissue retractor2001can be accessed inside of the horses lip. The retractor member2020is at the tongue base2053, the retractor member2020connects to a first end of the shaft2010. A portion of the shaft2010passes through the tongue2051, a portion of the shaft2010passes through the mandible2068, and the second end of the shaft connects to the anchor member2030, which is adjacent the mandible2068. In one embodiment, a portion of the shaft2010reaches through the mandible2068to an adjustable anchor member2030in front of the mandible2068. Optionally, a bolster can be placed to load the tissue retractor2001prior to exercise. In one embodiment, a bolster is placed between the mandible2068and the anchor member2030. In another embodiment, a bolster is placed between the tongue base2053and the retractor member2020.

FIG. 20Dshows an embodiment of the tissue retractor2001that takes advantage of certain unique circumstances present in horses. Specifically, a bridle is usually placed on the horse's head when racing to control the horse. Most bridle's have a bit2067, a bar which passes across the horse's mouth. This bit2067can be used as modified anchor to couple to and load the tissue retractor2001. Referring still toFIG. 20D, the tissue retractor2001passes from the tongue base2053to the superior surface of the tongue2051. The tissue retractor2001is unloaded most of the time and only becomes loaded when it is connected to the bit2067of the horse's bridle prior to exercise. In one embodiment, the shaft2010connects to an anchor member2030on the tongue2051surface, which is reversibly attached to the bit2067of a bridle during exercise. The retractor member2020is at the tongue base2053. Once the anchor member2030of the tissue retractor2001is loaded into the bit2067, the tongue base2053is retracted by the retractor member2020.

In some embodiments, referring now toFIGS. 20E-20F, the soft palate2066and the epiglottis2063are secured together. In some embodiments, a tissue retractor2001(i.e., an LTR) passes from the soft palate2066to the epiglottis2063to resist displacement of the soft palate2066and the epiglottis2063. In other embodiments, the tissue retractor2001passes from the soft palate2066to the epiglottis2063and restores the interlocked configuration between the soft palate2066and the epiglottis2063if the two should become displaced. In one embodiment, referring now toFIGS. 20E-20F, a tissue retractor2001directly opposes dislodging the soft palate2066from its normal position. An anchor member2030is positioned in front of the soft palate2066, a portion of the shaft2010passes backward through the soft palate2066and then another portion of the shaft2010passes through the epiglottis2063to a retractor member2020on the laryngeal surface of the epiglottis2063. A first end of the shaft2010is connected at or near the anchor member2030and a second end of the shaft2010is connected at or near the retractor member2020. Referring now toFIG. 20G, in one embodiment, a tissue retractor2001b,2001cis positioned through each PGF2057and each tissue retractor2001b,2001cattaches to a lateral aspect of the soft palate2066. In addition, a tissue retractor2001a(similar to the tissue retractor show inFIGS. 20E and 20F) may also be positioned to secure the soft palate2066and the epiglottis together.

Referring now toFIGS. 20A-20G, methods of treatment of a breathing disorder in a horse include, for example, inserting a shaft2010into a horses tongue2051, connecting a retractor member2020at or near a first end of the shaft2010, and connecting an anchor member2030at or near a second end of the shaft2010. The anchor member2030is external to the horses mandible2068. At least one of the shaft2010, the retractor member2020, and the anchor member2030interact to exert a pressure that prevents obstruction of the horses airway to airflow2069. A tissue retractor2001for treatment of a breathing disorder in a horse can include a shaft2010sized for insertion into a horses tongue2051, a retractor member2020connected at or near a first end of the shaft2010, and an anchor member2030connected at or near a second end of the shaft2010, the anchor member2030is external to the horses mandible2068and at least one of the shaft2010, the retractor member2020, and the anchor member2030interact to exert a pressure that prevents obstruction of the horses airway.

Referring now toFIG. 20D, some methods for treatment of a breathing disorder in a horse include inserting a shaft2010into a horses tongue2051, connecting a retractor member2020at or near a first end of the shaft2010, and connecting an anchor member2030at or near a second end of the shaft2010, the anchor member2030is external to the horses tongue2051. The anchor member2030is hooked to a bit2067of the horses bridal. Hooking the anchor member2030to the bit2067“loads” the tissue retractor2001. At least one of the shaft2010, the retractor member2020, the anchor member2030, and the bit2067interact to exert a pressure that prevents obstruction of the horses airway to airflow2069. A tissue retractor for treatment of a breathing disorder in a horse includes a shaft2010sized for insertion into a horses tongue2051, a retractor member2020connected at or near a first end of the shaft2010, and an anchor member2030connected at or near a second end of the shaft2010, the anchor member2030is external to the horses tongue2051and the anchor member2030hooks to a bit2067of a horses bridal. At least one of the shaft2010, the retractor member2020, the anchor member2030, and the bit2067interact to exert a pressure that prevents obstruction of the horses airway to airflow2069.

Referring now toFIGS. 20E-20F, a method for treatment of a breathing disorder in a horse includes inserting a shaft2010through an epiglottis2063and a soft palate2066, connecting a retractor member2020at or near a first end of the shaft2010, the retractor member2020is external to the soft palate2066, and connecting an anchor member2030at or near a second end of the shaft2010, the anchor member2030is external to the epiglottis2063. At least one of the shaft2010, the retractor member2020, and the anchor member2030interact to maintain the epiglottis2063adjacent to the soft palate2066and to prevent obstruction of the horses airway.

The method for treatment can also include, referring now toFIG. 20G, positioning a first tissue retractor2001abetween the epiglottis and the soft palate2066and positioning a second tissue retractor2001bsuch that a retractor member is in the region of the pharyngoglossal fold2057and at least a portion of the anchor member is attached to the soft palate2066. Optionally, a third tissue retractor2001cis positioned such that a retractor member is in the region of the other pharyngoglossal fold2057and at least a portion of its anchor member is attached to the soft palate2066. At least one of the first tissue retractor2001a, the second second tissue retractor2001band the third tissue retractor2001cinteract to distribute a force and to prevent obstruction of the horses airway.

Disclosed here, for example, aFIGS. 21A-21Hand22A-22H, are methods and devices for non-invasively retracting mucosa and displacing soft tissue volume for the treatment of sleep apnea and related disorders. A major advantage of these non-invasive retraction methods is that no surgical procedure is needed, and suitable non-invasive devices can be easily inserted and removed by, for example, the patient or the treating medical professional.

At present the only effective non-invasive therapy for sleep apnea is CPAP. CPAP displaces the soft tissue with air pressure and, although effective in many cases, it is uncomfortable for the patient and has a very low compliance rate.FIG. 4Ddepicts the mechanism by which CPAP relieves airway obstruction. The only other non-invasive therapies which have some effect on sleep apnea are dental devices. Other effective non-invasive therapies include the use of dental devices that work by moving the jaw down and forward, thereby indirectly moving the entire floor of mouth and tongue. By this method the airway is expanded and the mucosa connecting the jaw to the pharynx is slightly stretched and stiffened. Unfortunately, the joint connecting the jaw to the skull can only be stretched a small amount so that there is a limit to how much the airway can be expanded. Therefore, at present, dental devices are only effective in some mild sleep disorder cases.FIG. 4Edepicts the mechanism by which a dental device relieves airway obstruction.

It is counterintuitive that any tissue retractor device could retract the tongue and other soft tissue in a patient's mouth without puncturing mucosa. The tongue and pharynx are highly sensitive to contact and any stimulation of the tongue and/or pharynx can cause gagging. Moreover, the whole region within the patient's mouth is covered with slippery mucosa and is always moving. Therefore, it is contrary to expectation that a non-invasive retraction device can remain in place in the soft tissue of a patient's mouth without some firm anchoring to tissue.

In one non-invasive embodiment referring now toFIGS. 21B-21Cand21G-21H a portion of a tissue retractor2101pushes or tugs on the PGF2157to retract the PGF2157thereby avoiding airway obstruction to airflow2169. More specifically, the retractor member2120lies within the groove formed by the base2153of the tongue2151and the lateral pharyngeal wall2165. A portion of the retractor member2120contacts the PGF2157, for example, a portion of the retractor member2120contacts along the vertical back surface of the PGF2157.

In one embodiment the retractor member2120is thin, soft and form fitted to comfortably distribute force to the mucosa of the PGF2157. The retractor member2120can be made of any of a number of materials suited to placement in a patient's oral cavity or pharynx, a non-limiting example is a soft gel-like silicone such as, for example, NuSil Technology MED-6380 firm RTV gel, available from NuSil Technology LLC, Carpinteria, Calif. The retractor member2120can extend solely in the region of the PGF2157. Alternatively, the retractor member can extend from the region of the PGF2157downward as far as the esophagus. In some embodiments the retractor member2120is sized to retract from the PGF2157to one or more of the upper esophageal spincter, the pyriform sinuses, the vocal folds, the aryepiglottic folds, the epiglottis and/or the lateral pharyngeal walls. Retractor members2120are sized in accordance with the desired placement and the desired extent of retraction force. The length of the retractor member2120can range from about 1 mm to about 100 cm, from about 0.5 cm to about 5 cm, and from about 1 cm to about 2 cm.

Retractor members2120are shaped to suit the region of placement and desired extent of retraction in accordance with patient anatomy. Suitable retractor members2120have a wedge shape or triangle shape as shown inFIG. 21H. In one embodiment, the widest plane of the wedge shaped retractor member2120ranges from about 1 mm to about 10 mm wide. In one embodiment, a retractor member2120is sized to (e.g., the wedge shaped retractor member widest plane) compresses the tongue base2153and decreases its compliance, thereby helping to prevent posterior collapse of the tongue base2153. The retractor member2120(e.g., the wider base) can then also coax the tongue base2153anteriorly (FIG. 21G-21H). The retractor member2120can have other shapes including, but not limited to, the shapes described inFIGS. 9A-9D.

The retractor member2120can be the shape of a hook and the retractor member2120can be used at many sites disclosed herein. To remain in place without movement the hook shaped retractor member2120should be “loaded” to exert retraction force while in position. Positioning the retractor member2120at the PGF2157site is advantageous, because the retractor member2120is surrounded by tissue on all sides of the PFG2157and even the top of the retractor member2120is covered by the overhanging lateral part of the tongue2151. In one embodiment, referring now toFIG. 21C, the retractor member2120has the shape of a hook and the retractor member2120hooks the PGF2157much like eyeglasses hook over the ear. The hook shaped retractor member2120exerts a force on the PGF2157that avoids the obstruction of the patient's airway. The muscles that pass from the lateral pharyngeal walls into the tongue act as a portion of a spinchter that provides and prevents access to the airway, such as during swallowing. The tissue retractors disposed on the various regions of soft tissue pull this spinchter open thereby to maintain opens of the patient's airway.

The tissue retractor2101retractor member2120is connected to the first end of the shaft2110and its anchor member2130is connected to the second end of the shaft2110. In some embodiments the shaft2210passes directly from the top of the retractor member2120over the PGF2157to connect via the anchor member2130with one or more of anchoring sites. Suitable anchoring sites include, for example, the patient's teeth and particularly the molars. The teeth2198and specifically the molars are at a relatively short distance from the PGF2157. For example, molar teeth are at a distance of from about 1 mm to about 5 cm from the PGF2157. Alternatively, the anchor member2130may be anchored to one or more dental appliances that are well known in the art. Suitable dental appliances can be anchored to teeth (e.g., molar teeth), the patient's gums, dental posts, or dental bridges.

The anchor member2130can couple to one or more of the patient's teeth2198. For example, the anchor member2130can surround all or a portion of a patient tooth2198. In one embodiment, the anchor member2130has the shape of a hook and surrounds at least a portion of the tooth2198(see, e.g.,FIG. 21G-21H).

Dental appliances can have a wide variety of mechanisms to attach to the shaft2110or to an anchor member2130. One method suitable for attaching the shaft2110to the a dental appliance or to a patient's teeth include the use of rubber bands, for example, rubber bands similar to those typically used in orthodontics. In one embodiment, a tissue retractor2001employs a orthodontic rubber band as its anchor member2130and the rubber band reversibly couples to a dental appliance in the patient's mouth. In another embodiment, a tissue retractor2001employs a rubber band as its shaft2110, for example, one portion of a rubber band reversibly attaches to a portion of a retractor member2120that is placed in the region of the PGF2157and another portion of the rubber band reversibly attaches to an anchor member2130that couples to a molar. The advantage of the embodiment employing a removable shaft2110is that the shaft2110device (e.g., a rubber band) is easily removable and replaceable, completely adjustable, and the distance traveled by the shaft2110between the retractor member2120and the to anchor member2130could be very short, thereby achieving the goal of retraction of the PGF2157with minimal patient discomfort.

Referring now toFIGS. 21D-21Fand22A-22H, in another embodiment a tissue retraction clamp2193,2293is designed to remain attached to a mucosal fold2159,2259such as a tissue fold in a patient's oral cavity or pharynx by non-invasive means. The tissue retraction clamp2193,2293can remain attached to the tissue fold for a limited amount of time, or, optionally, the tissue retraction clamp2193,2293can remain attached to the tissue fold indefinitely. In one embodiment, the tissue retraction clamp2193,2293is clipped over (e.g., it surrounds) a mucosal fold2159in the oral cavity or pharynx such that that it can remain in place for extended periods or time. Mucosal folds2159,2259are malleable such that compression of the mucosal fold2159,2259with the clamp2159,2259indents at least a portion of the tissue of the mucosal fold2159,2259and maintains the clamp2159,2259substantially in its position on the mucosal fold2159,2259such that the clamp2159,2259resists migration out of position. (See, e.g.,FIGS. 21D-Fand22A-22C).

Referring now toFIGS. 21D and 22A, in some embodiments, the tissue retraction clamp2193,2293is sized for placement in a patient's upper airway on, for example, a mucosal fold2159,2293located in the patient's upper airway. In one embodiment, the clamp2193,2293includes a first arm2194,2294and a second arm2195,2295. A shaft2110,2210can connect the first arm2194,2294and the second arm2195,2295. For example, the first arm2294is connected at or near a first end of the shaft2210and the second arm2295is connected at or near a second end of the shaft2210. In some embodiments, referring now toFIGS. 21E-21Fand22A-22B, the clamp2193,2293includes a first magnet2191,2291that is attracted to a second magnet2192,2292. The second magnet2192,2292can have a polarity opposite to the first magnet2191,2291, alternatively, the second magnet2192,2292can be made of a material (e.g., a suitable non ferrous material) to which the first magnet2191,2291is attracted. In some embodiments, referring now toFIG. 22A, the first magnet2291is connected at or near a first end of the shaft2210and the second magnet2292is connected at or near a second end of the shaft2210.

Mucosal folds2159,2259are malleable and compression by the clamps2193,2293indents the tissue fold and resists migration of the clamps2193,2293out of position. In one embodiment, the ends of the arms2194,2195,2294,2295exert a compressive force on the mucosal folds2159,2259. In one embodiment, the compressive force is mechanical. Suitable mechanical forces may be generated by the plastic physical properties of all or a portion of the clamp2193,2293. In some embodiments, a spring is incorporated into the clamp2193,2293, for example on one or more of the first arm2194,2294and the second arm2195,2295. In one embodiment, all or a portion of the clamp2193,2293includes nitinol or other material that maintains force. Optionally, portions of the clamp2193,2293contain magnets (or a magnet and a non ferrous material) that create a force of attraction when brought in proximity to one another. In another embodiment, the clamp2193,2293is loaded at its apex and the arms2194and2195or2294and2295are attracted to one another by a spring mechanism similar to what found in a paper clip.

Referring now toFIGS. 21A-21Hand22A-22H, a method for treatment of a breathing disorder includes positioning a clamp2193,2293sized for placement in a patient's upper airway on a mucosal fold2159,2259located in a patient's upper airway and compressing the mucosal fold2159,2259with the clamp2193,2293at a pressure that substantially maintains the clamp2193,2293in its position on the mucosal fold2159,2259. The clamp2193,2293indents at least a portion of the mucosal fold2159,2259to prevent obstruction of the patient's airway. In some embodiments, the clamp2193,2293exerts a pressure that is not greater than the perfusion pressure of the mucosal fold2159,2259. In some embodiments, the clamp has a first magnet2191,2291and a second magnet2192,2292of opposite polarity, more specifically, the first magnet2191,2291is connected at or near a first end of a shaft2110,2210and the second magnet2192,2292of opposite polarity is connected at or near a second end of the shaft2110,2210. In some embodiments, the clamp2193,2293has a first arm2194,2294connected at or near a first end of a shaft2110,2210and a second arm2195,2295connected at or near a second end of the shaft2110,2210, the first arm2194,2294is attracted to the second arm2195,2295by a spring force. In some embodiments, the clamp2193,2293has a shaft2110,2210that exerts at least one of a protracting or a retracting force on the mucosal fold2159,2259.

In some embodiments, a tissue clamp2193,2293for treatment of a breathing disorder includes a first arm2194,2294connected at or near a first end of a shaft2110,2210and a second arm2195,2295connected at or near a second end of the shaft2110,2210. The first arm2194,2294, the second arm2195,2295and the shaft2110,2210are dimensioned to surround a mucosal fold2159,2259located in a patient's upper airway. The first arm2194,2294is attracted to the second arm2195,2295by a force and the force indents at least a portion of the mucosal fold2159,2259to prevent obstruction of the patient's airway. The force can be, for example, a magnetic force or a spring force.

In one embodiment, referring now toFIG. 21F, a clamp2193has a first magnet2191and a second magnet2192that is attracted to the first magnet2191thereby to create an attraction force that indents the mucosal fold2159. In one embodiment, a first end of a shaft2110A has third magnet2110B and the third magnet2110B is attracted to at least a portion of the clamp2193. For example, the third magnet2110B is attracted to the second magnet2192. Optionally, the shaft2110A and its third magnet2110B are brought into proximity to the clamp2193thereby to move the mucosal fold2159in a direction that creates an indentation in at least a portion of the mucosal fold to prevent obstruction of the patient's airway. In some embodiments, the shaft2110A is attached to an anchor member such as, for example, an anchor member that anchors about a dental structure such as, for example, a tooth. In some embodiments, a clamp2193placed surrounding a mucosal fold2159a patient's oral cavity or pharynx and when the patient seeks to “load” the tissue retractor the clamp2193becomes the retractor member, the magnet2110B at the first end of the shaft2110A is brought in proximity to the clamp2193and attracts to the clamp2193, the second end of the shaft2110is connected to an anchor member, for example, the second end of the shaft2110is attached to an anchor member having a hook shape that surrounds at least a portion of the patient's tooth. Accordingly, referring now toFIGS. 21F and 22F, magnets can be used to reversibly couple a clamp2193,2293, to an anchor member2230via a shaft211A,2210. In one embodiment, the clamp2193,2293compresses the mucosa (e.g., the mucosal fold2159,2259) and the retraction via the anchor member2230and the shaft2210retracts the edge of the tissue fold.

In some embodiments, the tissue retraction clamp2193,2293is clipped over (e.g., it surrounds) a mucosal fold2159,2259in the oral cavity or pharynx such that that it can remain in place for extended periods or time without connection to an anchor (FIGS. 21C-21Eand22A-22D). In one embodiment, referring now toFIG. 22C, the clamp2293includes a shaft2210connected at each end by an arm (e.g., the first arm2294and the second arm not shown in this figure). The clamp2293surrounds the mucosal fold2259and both compresses the mucosa and retract the edge of the soft tissue fold.

In some embodiments, multiple clamps are employed. Referring now toFIG. 22D, two clamps2293A and2293B are connected by a shaft2210C that exerts force in an expanding direction between the clamps2293A,2293B. For example, the force provided by the shaft2210C can protract or lengthen the soft tissue. In some embodiments, two clamps are employed to protract or lengthen tissue without use of a shaft therebetween.

In some embodiments, referring toFIGS. 22D and 22H, a method for treatment of a breathing disorder includes positioning a clamp2293A sized for placement in a patient's upper airway on a mucosal fold2259located in a patient's upper airway and compressing the mucosal fold2259with the clamp2293A at a pressure that substantially maintains the clamp2293A in its position on the mucosal fold2259. Positioning a second clamp2293B sized for placement in the patient's upper airway on another portion of the mucosal fold2259and compressing the other portion of the mucosal fold2259with the second clamp2293B at a pressure that substantially maintains the second clamp2293B in its position on the other portion of the mucosal fold2259. The clamp2293A indents at least a portion of the mucosal fold2259and the second clamp2293B indents at least a portion of the other portion of the mucosal fold2259and the clamp2293A and the second clamp2293B exert a force (e.g., a protracting force) between the mucosal fold2259and the other portion of the mucosal fold2259to prevent obstruction of the patient's airway. In one embodiment, a shaft2210C is disposed between the clamp2293A and the second clamp2293B, the shaft2210C exerts at least one of a protracting or a retracting force on the mucosal fold2259.

The non-invasive retractor clamp(s)2193,2293can be used in all sites within the upper airway where mucosal folds2159,2259are present or where mucosal folds2159,2259can be formed by grasping tissue. These upper airway sites include without limitation, the PGF, the frenulum, the lateral tongue surface, tonsillar folds (FIGS. 22E-22F), the soft palate (FIG. 22G), the pharyngeal walls, the floor of the mouth, and the aryepiglottic fold. In some embodiment, indentation of the mucosal fold maintains all or a portion of the patient's airway in the open position. Some of these sites within the patient's upper airway have extensive sensory innervation, however, so long as the contact between the clamp2193,2293and mucosa is stable and immobile the sensation disappears within minutes after placing the clamp2193,2293about the mucosal fold2159,2259. This loss of sensation is called habituation and is well known to sensory physiologists. The stability of contact between the retractor clamp and the region of mucosa can be increased by the use of adhesives known in the art. Adhesives effective on mucosa can include, but are not limited to, fibrin, hydrogels, and cyanoacrylic glues. It is also important that the site for the clamp2193,2293as well as the shaft2110,2210and the anchor2130,2230be placed such that the least amount of dynamic contact occurs between these various components and the mucosa. In addition, when a clamp2193,2293is used on an ongoing basis the compression exerted by the clamp2193,2293(e.g., the compression between the arms of the clamp2193,2293) should not exceed the pressure at which capillary blood circulation stops, called the perfusion pressure, which is about 25 mm Hg or 34 cm H2O.

Referring now toFIGS. 23A-23L, other non-invasive methods and devices for soft tissue and/or mucosa protraction and/or retraction use vacuum and/or bolsters to displace, protract, and/or to retract soft tissue.FIG. 23Ais a side view showing a patient's floor of mouth2376that extends from the mandible2368to the hyoid bone2377.FIG. 23Bis a front view showing that the floor of mouth2376connects to the bottom of each side of the mandible2368.FIG. 23Cis a top view showing the tongue2351and the triangular root2349of the tongue below the tongue2351. The anterior extension of the root2349is the genioglossus muscle2363(seen inFIGS. 23A and 23B) that inserts into the mandible2368.

Another embodiment of this invention is to increase the pharyngeal airspace by depressing the floor of the mouth. The floor of the mouth2376is composed of muscles and other soft tissue that attaches to the hyoid bone2377posteriorly and attaches to the mandible2368anteriorly and laterally. The tongue2351sits on the floor of the mouth2376and follows its movements. For example when the jaw is moved forward or downward the tongue2351moves along with it. Similarly when the hyoid bone2377moves forward it displaces the back of the tongue in the same direction. Some surgical procedures try to take advantage of this relationship by wiring the hyoid bone2377in a more forward position by wiring it to the front of the mandible2368. Unfortunately, the hyoid bone2377has many other attachments that resist being repositioned.

In contrast to prior approaches that focus on moving the bony attachments of the floor of the mouth2376, in one embodiment, the soft tissue of the floor of the mouth2376is moved/repositioned. Specifically, in one embodiment, the bottom of the tongue (i.e., the root of the tongue2349) that rests on the floor of the mouth2376is triangular shaped and smaller then the overall area of the floor of the mouth2376(FIG. 23I). Therefore the floor of the mouth2376can be reached between the tongue root2349and the mandible2368. When the area between the tongue root2349and the mandible2368is depressed the root of the tongue2349is depressed as well. Although the entire exposed floor of the mouth2376can be depressed, this is inefficient, as the most important area to move is the tongue base.

Referring now toFIG. 23Da bolster2340is pushed downward and slightly anterior by a shaft2310. The shaft2310and the bolster2340exert a protracting force on the floor of mouth2376. The protracting force indents the floor of mouth2376, which alters the position of the tongue2351and the PGF2357. Referring now toFIG. 23E, the floor of mouth2376is depressed by the bolster2340, which creates room that depresses the tongue2351by the same amount that the floor of the mouth2376is depressed, which results in a decreased height of tongue2351surface at, for example, the tongue curve. Referring nowFIG. 23F, the bolster2340is seen from above. Note the anterior displacement of the base of the tongue2351that results from use of the bolster2340.

In one embodiment, the area of the floor of the mouth2376around the tongue base is depressed thereby moving the tongue base down and as a result of the downward movement of the tongue base the pharyngeal airspace is increased. For practical purposes the PGF2357places a limit on how far back the floor of the mouth2376can be reached. In one embodiment a tissue retractor with a silicon bolster2340measuring 0.5 cm×0.5 cm×1 cm is situated longitudinally alongside the undersurface of the tongue2351with one end abutting the PGF2357. In one embodiment, downward pressure exerted on the bolster2340is achieved by a dental appliance attached to the molar teeth or a palatal prosthesis that is connected to the bolster2340by, for example, the shaft2310. The downward pressure exerted on the bolster2340depresses the floor of the mouth2376. The bolster2340exerts a protracting force on the floor of the mouth2376. Not all the downward movement of a local area of floor of mouth2376depression is transferred to the tongue2351. However, an increase in the pharyngeal airspace that avoids obstruction of the patient's airway is beneficial.

In addition to depression of the floor of the mouth2376, the displacement force can be exerted forward (anterior), inward (medial) or outward (lateral). Forward displacement is beneficial, because the pharyngeal airspace is expanded to the extent that the tongue base also moves forward. Inward movement is beneficial if both sides exert a grasping force on the tongue2351and thereby resist backward tongue collapse. Outward movement is also beneficial to the extent that the outward movement stretches and tenses tongue tissue thereby also preventing backward tongue collapse.

Non-invasive coupling to mucosa in the oral cavity or pharynx is difficult. Reversible non-invasive coupling may be accomplished by using vacuum to suck a volume of mucosa into the vacuum opening.FIG. 23Gshows a vacuum device2347retractor member2320applied to the lateral tongue2351. The vacuum device2347is positioned below the tongue2351adjacent the floor of mouth2376and the PGF2357.FIG. 23Hshows a vacuum device2347employed as a retractor member2320that displaces tongue2351tissue. Use of the vacuum device2347results in tongue2351tissue displacement that is reflected by the decreased height of the tongue2351surface.FIG. 23Ishows a vacuum device2347employed as a retractor member2320that displaces tongue2351tissue and results in anterior displacement of the base of the tongue2351that avoids obstruction of the airway due to collapse of the tongue2351toward the soft palate2366(seeFIG. 23G).

Referring now toFIGS. 23G-23I, vacuum can be applied through suction or vacuum devices2347placed over segments of the tongue2351to cause displacement of tongue2351tissue into the suction. Because the volume of a patient's tongue2351is constant, the use of suction on the tongue2351tissue displaces a portion of tongue2351tissue and the displaced tongue2351tissue is moved from other parts of the tongue2351. In one embodiment, suction is employed on a portion of a patient's tongue2351tissue and displaces tongue2351tissue from the tongue base. Vacuum can be used to displace soft tissue volume, for example, vacuum can be used on the tongue2351by a relatively large device that sucks tissue volume into the vacuum device2347and thereby changes the shape of the tongue2351such that volume is removed from the tongue base. Referring now toFIGS. 23G-23I, in one embodiment a retraction member2320is a vacuum device2347that is applied to the lateral tongue2351. The vacuum device2347is positioned below the tongue2351adjacent the floor of mouth2376and the PGF2357. The vacuum device2347vacuums and displaces a portion of the tongue2351tissue. The displacement of the tongue2351tissue is reflected by the decreased height of the tongue2351surface (seeFIG. 23E). The vacuum device2347tongue2351tissue displacement results in anterior displacement of the base of the tongue2351thereby to avoid obstruction of the airway due to collapse of the tongue toward the soft palate2366(seeFIG. 23G).

Vacuum can be employed through suction devices that can be used to suction a retractor member onto a mucosal surface thereby to non-invasively attach the retractor member within the patient's oral cavity or pharynx. In one method, vacuum device2347is used to couple a retractor member to mucosa in the patient's oral cavity or pharynx. In one embodiment, the vacuum device2347is a retractor member2320that is applied to the PGF, for example, to the anterior surface of the PGF. Other suitable sites for placement of a vacuum device2347retractor member2320are the lateral and/or inferior tongue surface. Vacuum retraction may be applied to any suitable tissue and/or mucosa surface at a location in the oral cavity or pharynx where tissue retraction is beneficial to prevent patient airway obstruction.

FIG. 23Jshows a view of another vacuum device2347.FIG. 23Kshows a close up view of the vacuum device2347ofFIG. 23Jemployed as a tissue retractor.FIG. 23Lshows a close up view of the vacuum device2347ofFIG. 23Kemployed as a tissue retractor. Once this tissue is pulled into the vacuum device2347its interface with the walls of the vacuum device2347directly locks the tissue2350in place within the interior walls. In other words, if the retractor member2320is pulled in a lateral direction, the tissue2350is pulled also. The vacuum mechanism can be used in place of or in addition to embedded magnets, clips, or other tissue retraction devices. The vacuum device2347retractor member2320can include a suction cup of the type well known in the art and the vacuum is formed by pressing the suction cup against the patient's mucosa.

Referring now toFIGS. 23L-23N, in one embodiment, the interface between the suction device and the mucosa has well defined edges with interior walls of the vacuum device2347having an angle2354of between about 120° or less. In one embodiment, the angle2354is about 90°. In another embodiment, the angle2354is about 45°.

In one embodiment, referring now toFIGS. 23J and 23K, the vacuum device2347is connected via a tube2311to a vacuum source, for example. The tube2311allows vacuum to be delivered to the tissue2450. The vacuum device2347can be many sizes and shapes, a simple embodiment is a round opening 1 cm in diameter with inner walls 5 mm in depth. In one embodiment, the vacuum travels from a vacuum source via a tube2311to the vacuum device2347, which is positioned in the patient's mouth. In another embodiment the vacuum device2347is attached to a small air pump located and/or positioned in the patient's mouth.

Small electric pumps within the mouth can also be a source of vacuum. The air pump may be passive, composed, for example, of a small bladder with a one way valve such that movements of the tongue or jaw that compress the bladder force air out of the bladder through the one way valve. The elastic drive of the bladder to return to its larger volume shape forms the vacuum that attaches to tissue and/or that displaces tissue volume. The vacuum can be from a source inside the mouth and hooked to the vacuum device2347at some convenient spot via a tube. The amount of vacuum is sufficient to draw tissue into the coupler but not cause damage. Preferably this ranges from 0.1 to 100 cm of water pressure, in some embodiments, from 1 to 10 cm of water pressure.

The vacuum device2347is applied to a site to be moved and then vacuum is applied by the vacuum device2347. Turning off the vacuum or breaking the seal allows the vacuum device2347to disengage. In one embodiment, the maintenance of vacuum without leakage is aided by placing biocompatible viscous material in the area of soft tissue that contacts the inner walls of the vacuum device2347. An example of such biocompatible viscous material is the patient's own mucous.

In some embodiments, the vacuum device2347is attached to a modified anchor. In one embodiment, after a vacuum device2347couples to the mucosa it is displaced forward by a shaft. The vacuum device2347can have a single suction interface or, referring toFIG. 23L, multiple smaller suction interfaces2348a,2348betc. (e.g., mini suction cups). Viscous mucoid material or adhesive could be applied to the mucosa to aid in maintaining a seal between the mucosa and the vacuum device2347. Referring now toFIGS. 23J-23N, in one embodiment, a vacuum device2347includes one or more suction cup that suctions small amounts of tissue into the suction cup opening. The presence of the suction cup provides resistance to shear forces acting at the suction site.

FIG. 23Lshows a vacuum device2347having an angle2354of about 90°. It can be seen that the soft tissue2350pulled into the vacuum device2347conforms to the walls of the vacuum device2347such that the soft tissue2350resists lateral movement.FIG. 23Mshows another vacuum device2347having an angle2354of about 45°. The 45° angle is a size small enough to trap the soft tissue2350within the vacuum device2347. Further, the edges2354a,2354btrap the soft tissue2350such that the soft tissue2350resists movement when the angles2354measure about 45°. In one embodiment, the vacuum device2347is attached to a lumen and suction is pulled through the vacuum device2347through the lumen of the tube2311. In some embodiments, the soft tissue2350is pulled into and trapped inside the lumen of the tube2311. Referring still toFIG. 23M, the edges2354a,2354bform a rim around a portion of the vacuum device2347that prevents movement of the soft tissue2350. In this way, the shape of the vacuum device2347shown inFIG. 23Mresists the soft tissue2350from dislodging from the vacuum device2347.

FIG. 23Nshows another vacuum device2347having an angle2354of about 135° as the angle2354increases, somewhere around 135°, the walls and/or the edges2354a,2354bcannot prevent the soft tissue2350from sliding out of the vacuum device2347.

Referring now toFIGS. 23L-23Nthe vacuum device2347can grab the soft tissue2350and in some embodiments, can prevent motion, e.g., lateral motion, of the soft tissue2350by trapping the soft tissue2350within the vacuum device2347. In some embodiments, the vacuum device2347acts an anchor to which members such as, for example, a shaft and/or a retractor member can be attached. For example, in one embodiment, the vacuum device2347is coupled to soft tissue2350on the collgeneous top surface of the tongue where the tongue is stiff and is not easily movable.

In other embodiments, the vacuum device2347grabs soft tissue2350such that the soft tissue2350together with the vacuum device2347can be moved in a direction that avoids blocking airflow. In this way, the vacuum device2347may retract soft tissue2350. For example, the vacuum device2347grabs soft tissue2350on the tip of the patient's tongue such that the tongue may be retracted by exerting a pulling force on the vacuum device2347and moving an attached shaft2310in a desired direction of retraction.

Some tissue retractors initiate desirable remodeling of the patient's tissue. For example, in an embodiment where the retractor member has a head that measures between about 2 and about 3 cm in diameter the retractor member head is implanted in tongue tissue. Over a few months the tongue tissue remodels/reshapes to become thinner in the region exposed to the retractor head. For example, the tongue adapts quickly to pressure placed on it. After the tissue retractor has been placed for from about 1 to about 2 months the tissue retractor may need to be adjusted to compensate to the thinning of the tongue tissue. In some embodiment, all or a portion of the tissue retractor is designed in a manner that encourages tissue remodeling. Tissue remodeling can be permanent reshaping of tissue for beneficial effect. Alternatively, tissue remodeling can be semi-permanent reshaping of tissue for beneficial effect.

It is to be understood that the described embodiments are merely illustrative and that variations of the above-described embodiments can be devised by one skilled in the art without departing from the scope of the invention. It is therefore intended that all such variations be included within the scope of the following claims and their equivalents.