EP-4081144-B1 - SYSTEMS FOR TREATMENT OF OBSTRUCTIVE SLEEP APNEA

Inventors

• SOYKAN, ORHAN
• CHRISTOPHERSON, MARK
• GONZALES, DONALD, A.
• SKORICH, Stefan
• VANNEY, GUY
• KRONE, DOUGLAS

Dates

Publication Date

20260513

Application Date

20210219

Claims (15)

1. A device configured for treatment of obstructive sleep apnea, comprising: a temperature determinant (106) configured to chill and heat a circulating fluid, the temperature determinant (106) including a chiller, a heater, and a pump; an applicator (102) configured to receive the circulating fluid, the applicator (102) being sized and configured to contact a target surface of an oropharyngeal tissue including a soft palate, uvula, tongue, or pharyngeal wall and including - a bottom half having a tissue contacting surface and a temperature sensor (410) positioned at the tissue contacting surface, a top half coupled to the bottom half and having one or more leads coupled to the temperature sensor, wherein the one or more leads (420) extend from the bottom half of the applicator toward the temperature sensor, and an adjustable fixation system comprising a fixture arm (622) attached to the applicator (102) configured to couple to the applicator and provide adjustment of the applicator (102) with respect to a patient; and a controller (108) configured to facilitate heat transfer between the applicator (102) and the circulating fluid.
2. The device of claim 1, further comprising open foam insulation disposed on all surfaces of the applicator (102) that are not intended to come in contact with tissue.
3. The device of claim 1, further comprising closed foam insulation disposed on all surfaces of the applicator (102) that are not intended to come in contact with tissue.
4. The device of claim 1, further comprising a cryoprotectant sheet disposed on the applicator (102).
5. The device of claim 1, wherein the applicator (102) comprises an insulator disposed on all surfaces of the applicator (102) that are not intended to come into contact with tissue, the applicator (102) further comprising a cryoprotectant sheet that covers the applicator (102) including the insulator.
6. The device of claim 1, wherein the temperature sensor is a first temperature sensor, the device further comprising a second temperature sensor disposed on a fluid inlet of the applicator (102), a third temperature sensor disposed on a fluid outlet of the applicator (102), and a fourth temperature sensor disposed on or in a cryoprotectant sheet of the applicator (102).
7. The device of claim 1, further comprising one or more passages disposed within or on the applicator (102) for the one or more leads.
8. The device of claim 1, wherein the adjustable fixation system is configured to apply a predetermined force from the applicator (102) to the oropharyngeal tissue.
9. The device of claim 1, wherein the temperature determinant (106) has fail safe features of stored heat for thawing, fast heating, and cooling at a minimum rate of 1°C/sec and is configured to hold a temperature of the circulating fluid within ±1°C of a target temperature.
10. The device of claim 1, further comprising a guidance device configured to aid in positioning the applicator (102).
11. The device of claim 10, wherein the guidance device is an endoscope, an intra-oral probe, an external ultrasound probe or an electrical impedance measurement device.
12. The device of claim 1, further comprising a feedback system, wherein the controller (108) is configured to facilitate the heat transfer between the applicator (102) and the circulating fluid based on the feedback system.
13. The device of claim 12, wherein the feedback system comprises the temperature sensor and is configured to monitor the one or more temperature measurements at the tissue contacting surface.
14. The device of claim 13, wherein the controller (108) is configured to adjust a temperature of the circulating fluid and a treatment duration based on the one or more temperature measurements from the temperature sensor.
15. The device of claim 14, wherein the one or more temperature measurements comprise a morphology that includes time constants, discontinuities, rate of change, area under a curve, or oscillations.

Description

FIELD The present disclosure relates generally to minimally invasive treatment of obstructive sleep apnea. BACKGROUND Obstructive sleep apnea (OSA) is a sleep disorder that affects up to 20% of the adult population. OSA generally occurs during sleep when soft tissue enlarges and obstructs the pharyngeal airway, creating cessation of, or impeding, breathing due to the decrease in size of the upper airway, resulting in the breathing of the patient to repeatedly stop and restart. Obstruction can occur at one or more levels including the retropalatal and retrolingual areas, and if untreated could leave to the development of serious complications, including atrial fibrillation and heart failure. This enlargement of the tongue generally occurs due to excess body weight, causing adipose tissue to accumulate within the tongue. With the accumulation of adipose tissue, organs in the oral cavity, including the tongue, become enlarged and lose their firmness and grow in volume. Due to their inability to maintain their tone and their increase in size, they move into the airway and restrict airflow. One condition that is particularly concerning occurs when there is excess fat near the base of the tongue, which is adjacent the airway. Surgical correction (such as glossectomy) of such obstructions remains a challenge, specifically for the retrolingual area. Removal or ablation of tongue tissue has been utilized with poor results due to complications, such as severe bleeding, abscess formation, and/or the inability to move the tongue anterior enough to relieve the obstruction. Medical devices such as tongue trainers also result in limited mobility or inconvenience to the patient. Continuous positive airway pressure (CPAP) is a more noninvasive technique in relieving OSA than surgical operation, but is a remedy and not a permanent solution. Applying a stream of compressed air through the pharyngeal airway to overcome the collapsing soft tissue results in the patient being uncomfortable and fully dependent on the machine and its limitations, such as a stuffy nose, claustrophobia, skin irritation, pressure sores, and dry mouth. Additionally, the mechanics of the machine result in the CPAP mask possibly falling off during sleep, bothersome noises, and a leaky mask, all while being costly and electrically dependent. These factors lead to the patient having trouble falling asleep, demonstrating a faulty solution to curing OSA, since the patient will never be cured of their disease and will still have complications during sleep. Adipose cryolysis is the use of cold to selectively target the submucosal adipose tissue, leading to a reduction in tissue volume via the removal of effected fat cells. However, it is known that the effect of cold on cells depend on various factors, including the cell type, duration that the cells are exposed to cold, rate of cooling and warming, as well as the number of cooling and warming cycles. When the adipocytes are exposed to temperatures below -15°C, necrosis occurs. At temperatures around -10°C, adipocytes are forced into a pathway that is reminiscent of apoptosis. When the temperatures are in the range of -5°C to +10°C, cells may move into a hyper-metabolic state, resulting in thermogenesis, which may also reduce the lipid volumes, or result in adipocyte cell death. Above observations may indicate that the exposure to temperatures in the range of +5°C to - 15°C for 1 - 100 minutes may cause maximum damage to the adipose tissue while minimizing the damage to muscle. Furthermore, even when the 70-80% of the skeletal muscle is damaged, muscle does recover within few days, thanks to its regenerative capacity. These facts can be used during the design of the devices that can be used for the selective elimination of the adipose tissue while preserving the other types of tissues such as the skeletal muscle, blood vessels and the nerves. The removal of adipocyte tissue (fat) from the tongue is expected to reduce the volume of tissue in the oropharynx, and the reduction of this tissue is known to cure or reduce the severity of obstructive sleep apnea, as demonstrated by the clinical outcomes of other procedures, such as the glossectomy of the tongue and the mandibular advancement. Furthermore, the removal of the fat from within key tongue muscles, such as the genioglossus muscle, will improve the ability of these muscle groups to function, which in turn may result in the reduction of obstructive sleep apnea. These muscles do keep the tongue from falling back into the airway, in both their activated and passive states. Adipose tissue that is interspersed within the muscle act as a restriction to the muscle due to the mass and inability of the adipose tissue to move in the same manner as the adjacent muscle fibers. To date, however, cryolitic treatment of OSA has involved procedures analogous to ablation, merely substituting cryolitic cold for electrolytic heat and non-selectively destroying all tissues in