Tongue cryoprobes for treatment of obstructive sleep apnea, and associated systems, devices and methods
The tongue cryoprobe system addresses the limitations of existing OSA treatments by offering a minimally invasive, targeted thermal treatment for airway obstructions, enhancing patient safety and recovery, and expanding treatment accessibility.
Patent Information
- Application Number
- PCT/US2025/032067
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-06-03
- Filing Date
- 2025-06-03
- Publication Date
- 2025-12-11
AI Technical Summary
Current treatments for obstructive sleep apnea (OSA) such as CPAP and surgical procedures are invasive, costly, and associated with significant risks and complications, while non-invasive methods like adipose cryolysis lack selectivity and cause tissue damage.
A minimally invasive sleep apnea treatment system using a tongue cryoprobe with a tapered applicator and onboard electronics for precise temperature control, allowing targeted adipose cell death at multiple airway obstruction sites without damaging surrounding tissues.
The system provides a more permanent solution to OSA by reducing airway obstruction with lower surgical risks, improved patient compliance, and faster recovery times, making it accessible to a broader range of healthcare providers.
Smart Images

Figure US2025032067_11122025_PF_FP_ABST
Abstract
Description
TONGUE CRYOPROBES FOR TREATMENT OF OBSTRUCTIVE SLEEPAPNEA, AND ASSOCIATED SYSTEMS, DEVICES AND METHODSCROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims the benefit of U.S. Provisional Patent Application No. 63 / 655,555, filed June 3, 2024, and titled “TONGUE CRYOPROBES FOR TREATMENT OF OBSTRUCTIVE SLEEP APNEA, AND ASSOCIATED SYSTEMS, DEVICES AND METHODS,” the disclosure of which is incorporated herein by reference in its entirety. The present application is related to the following applications, the disclosures of which are incorporated herein by reference in their entireties: U.S. Provisional Patent Application No. 63 / 655,537, [Attorney Docket No.151139.8009.US00], filed June 3, 2024, and titled “SOFT PALATE CRYOPROBES FOR TREATMENT OF OBSTRUCTIVE SLEEP APNEA, AND ASSOCIATED SYSTEMS, DEVICES AND METHODS”; and International Patent Application No. TBD [Attorney Docket No.151139.8009.WO00], filed TBD, and titled “SOFT PALATE CRYOPROBES FOR TREATMENT OF OBSTRUCTIVE SLEEP APNEA, AND ASSOCIATED SYSTEMS, DEVICES AND METHODS”.TECHNICAL FIELD
[0002] This present technology relates to tongue cryoprobes for treatment of obstructive sleep apnea, and associated systems, devices and methods.BACKGROUND
[0003] Obstructive sleep apnea (OSA) is a condition characterized by repeated episodes of partial or complete obstruction of the upper airway during sleep, leading to disrupted sleep and various health complications. The obstruction typically results from the enlargement of soft tissues in the oropharyngeal area, such as the soft palate, base of the tongue, and lateral pharyngeal walls, often due to excess body weight and the accumulation of adipose tissue in the upper airway. As these tissues lose firmness and increase in volume, they can encroach upon the airway and restrict airflow, particularly during sleep. Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Devices (MADs) are common non-invasive methods used to manage OSA. CPAPdelivers a stream of compressed air to keep the airway open but is not a permanent solution and is associated with poor patient compliance, high cost, reliance on electricity, and side effects such as nasal congestion, claustrophobia, skin irritation, pressure sores, and dry mouth. The CPAP device can also be noisy and may disrupt sleep. MADs work by repositioning the lower jaw to relieve airway obstruction, but these devices are primarily effective for mild OSA, often have poor compliance rates, and can cause bite changes as well as cosmetic concerns.
[0004] To provide more permanent solutions for OSA, invasive surgical procedures such as glossectomy (removal of part of the tongue), uvulopalatopharyngoplasty (removal or reshaping of tissue from the throat), and thermal treatments like ablation or adipose cryolysis within the anatomy of the upper airway have been utilized. While these approaches can address the underlying anatomical causes of airway obstruction, they are also associated with significant risks. Patients undergoing these procedures may experience severe bleeding, abscess formation, impaired tongue movement, prolonged recovery times, and substantial morbidity. Additionally, ablation and similar techniques for inducing adipose cell death via cooling can result in non-selective tissue destruction, further increasing the risk of complications and potentially harming surrounding healthy tissues. These limitations highlight the need for alternative, minimally invasive thermal treatment systems that can effectively induce adipose cell death via cooling to treat OSA, while avoiding the drawbacks associated with conventional techniques.BRIEF DESCRIPTION OF THE DRAWINGS
[0005] Features, aspects, and advantages of the presently disclosed technology may be better understood with regard to the following drawings.
[0006] FIG. 1 shows a sleep apnea treatment system including a thermal treatment unit and a cry oprobe, in accordance with embodiments of the present technology.
[0007] FIG. 2 shows the thermal treatment unit of FIG. 1.
[0008] FIG. 3 shows a tongue cryoprobe, in accordance with embodiments of the present technology.
[0009] FIG. 4 shows an applicator of the tongue cryoprobe of FIG. 3.
[0010] FIGS. 5A-5D show various views of an applicator with a tapered tip, in accordance with embodiments of the present technology.
[0011] FIGS. 6-8 show a hollow cavity of a treatment component with various flow path designs, in accordance with embodiments of the present technology.
[0012] FIG. 9 shows an applicator combined using a heat cure adhesive, in accordance with embodiments of the present technology.
[0013] FIG. 10 shows an applicator made of dissimilar materials, in accordance with embodiments of the present technology.
[0014] FIG. 11 shows a ferrule coupling mechanism, in accordance with embodiments of the present technology.
[0015] FIGS. I2A and I2B show an applicator and a flexible circuit integrated with onboard electronics, in accordance with embodiments of the present technology.
[0016] FIG. 13 shows a fabric shaped for an applicator, in accordance with embodiments of the present technology.
[0017] FIG. 14 shows an applicator with fabric integration, in accordance with embodiments of the present technology.
[0018] FIG. 15 shows an insulator, in accordance with embodiments of the present technology.
[0019] FIG. 16 shows an applicator with the insulator of FIG. 15.
[0020] FIG. 17 shows working channels, in accordance with embodiments of the present technology.
[0021] FIGS. 18A-18C show a working channel assembly, in accordance with embodiments of the present technology.
[0022] FIGS. 19A and 19B show an arm of a tongue cryoprobe in various states, in accordance with embodiments of the present technology.
[0023] FIGS. 20A-20D show various views of a conduit system, in accordance with embodiments of the present technology.
[0024] FIGS. 21A-21D show various views of a coupling member, in accordance with embodiments of the present technology.
[0025] FIG. 22 shows a kit for a sleep apnea treatment system, in accordance with embodiments of the present technology.
[0026] FIGS. 23A-23D show procedural stages for thermally treating the oropharyngeal area, in accordance with embodiments of the present technology.
[0027] FIGS. 24-27 show various visualization aids, in accordance with embodiments of the present technology.
[0028] A person skilled in the relevant art will understand that the features shown in the drawings are for purposes of illustrations, and variations, including different and / or additional features and arrangements thereof, are possible.DETAILED DESCRIPTIONI. Overview
[0029] Embodiments of the present technology relate to treatment of obstructive sleep apnea (OSA). OSA is a sleep disorder that affects up to 20% of the adult population, and generally occurs when enlarged soft tissue obstructs the pharyngeal airway and impedes a patient’s breathing. More specifically, the obstruction decreases the size of the airway which results in irregular breathing (e.g., repeated starting and stopping) during sleep. If untreated, OSA can lead to the development of serious complications, including atrial fibrillation and heart failure. Soft tissue enlargement can occur at one or more levels of the oropharyngeal area, including at the retropalatal and retrolingual areas of the oral cavity. The retropalatal areas include the back pail of the palate in the oral cavity (e.g., the soft palate), and the retrolingual areas include the back part of the tongue in the oral cavity (e.g., the base of the tongue (BoT)) and extend to the throat. Enlargement of the soft tissue generally occurs due to excess body weight, causing adipose tissue to accumulate within the tissues of the oropha ynx. As a result, muscles in the oral cavity, including the soft palate and tongue, can lose their firmness and grow in volume, thereby causing the enlarged muscles to move into the airway and restrict airflow.
[0030] Technologies used to treat OSA include non-invasive devices such as continuous positive air pressure (CPAP) and mandibular advancement devices (MAD), as well as surgicalmodifications such as glossectomy and uvulopalatopharyngoplasty. CPAP involves applying a stream of compressed air through the pharyngeal airway to overcome enlarged soft tissue. Although CPAP is a more noninvasive technique in relieving OSA than surgery, it is merely a remedy and not a permanent solution and / or have a history of poor compliance. CPAP is also expensive, requires a reliance on electricity, and is associated with side effects such as stuffy noses, claustrophobia, skin irritation, pressure sores, and dry mouth. Additionally, the CPAP machine can fall off during sleep and is loud, thereby disrupting the patient’s sleep.
[0031] MADs work by slowly advancing the mandible to bring the obstructing soft tissue forward to relieve obstruction. These devices typically are used in patient’s suffering from mild OSA and have very poor compliance as well as a potential for both occlusion and cosmetic issues. Surgical modifications used to relieve OSA also create issues due to their more invasive nature. For example, a glossectomy, in which a part of the tongue is removed, can cause severe bleeding, abscess formation, and / or the inability to move the tongue anterior enough to relieve the obstruction. Thus, many of the current treatments for OSA provide limited results or create much inconvenience to patients.
[0032] Patients with OSA can generally have a higher percentage of adipose deposits in the areas of obstruction, specifically, in the soft palate, tongue (e.g., BoT), and lateral pharyngeal walls. Removal of the fat deposits in these areas using adipose cryolysis (i.e., the use of a cold treatment to selectively target the submucosal adipose tissue) can relieve OSA symptoms while preserving surrounding tissue, and lead to a reduction in tissue volume via the removal of effected fat cells.
[0033] The effect of cold on cells depends on various factors, including cell type, cold duration exposure, rate of cooling and / or warming, and number of cooling and / or warming cycles. To date, however, cryolitic treatment of OSA has involved procedures analogous to ablation, merely substituting cryolitic cold for electrolytic heat and non-selectively destroying tissue in a similar manner. These procedures include similar complications to treatment with ablation. As a result, a need exists for an improved device, and related systems and methods for treating OSA with thermal treatment.
[0034] Embodiments of the present technology, which include a sleep apnea treatment system capable of treating OSA with thermal treatment, can help mitigate many of the issues described above and herein. The sleep apnea treatment system can include a tongue cryoprobe configured to treat atongue (e.g., at the BoT, lingual tonsils, etc.), a thermal treatment unit configured to store, generate, and / or deliver a chilled or heated fluid to the tongue cryoprobe, and a controller electrically coupled to the tongue cryoprobe and the thermal treatment unit.
[0035] The tongue cry oprobe can include a handle and an applicator coupled to the handle. The handle can include one or more fluid tubes and an arm that can be coupled to the one or more fluid tubes. The configuration of the handle and the applicator can enable a user (e.g., a physician or healthcare professional) to position the tongue cry oprobe on the BoT and / or lingual tonsils. For example, the applicator (e.g., a distal end portion of the applicator) is generally thin and tapered which advantageously can enable the applicator to reach the BoT and the lingual tonsils, which are deep within the oral cavity and challenging to access. Additionally, the applicator can include a width generally large enough to provide contact coverage to a majority of the tongue, yet tapered toward the distal end portion such that the applicator can be blindly and intuitively placed into the depths of the vallecula of the patient. Decreasing the height of the applicator in the oral cavity can also increase the user’ s ability to maneuver the applicator onto the tongue, especially for patients with an abundance of tissue or anatomic constraints in the oropharynx (e.g., female patients), and thus reduces the time spent positioning the tongue cryoprobe and the length of the surgical procedure.
[0036] The tongue cryoprobe can further include a working channel assembly. The working channel assembly can include a base and one or more working channels that can be coupled to the base. The working channel assembly can be coupled to the applicator and a distal end portion of the arm such that the thickness of the working channel assembly does not reduce visualization and maneuverability of the tongue cryoprobe. The user can guide one or more working instruments (e.g., endoscopes and / or suction tubes) through the one or more working channels throughout the procedure. The distal end of the working channels can open into a space between the end of the soft palate and the epiglottis, allowing the user to visualize placement of the tongue cryoprobe at the target area. Additionally, the working channels can be bilateral, allowing for visualization of the target area even if the tongue cryoprobe is at an angle during placement. The working instruments can provide enhanced visualization of the target area to position the applicator and / or can monitor the target area throughout thermal treatment. In some embodiments, the arm includes a triggering mechanism that provides traction between the applicator and the tongue. For example, the user activates the triggering mechanism (e.g., by distally pushing the handle) once the applicator is positioned at the target area,causing the arm to proximally pull the applicator onto the target area. The triggering mechanism can enhance contact between the applicator and the target area, enhancing thermal treatment of the target area.
[0037] In some embodiments, the one or more fluid tubes include an inlet tube and an outlet tube positioned to direct a temperature-controlled fluid (e.g., chilled fluid, heated fluid, etc.) to and from a surface of the applicator. The surface of the applicator can be an active surface that is minimally invasive and thermally treats the target area. For example, the applicator surface cools the BoT to induce fat specific cell death at the BoT without using surgical techniques typically associated with adipose cryolysis (e.g., cryolitic ablation). In some embodiments, the patient’s lingual tonsils are positioned between the surface of the applicator and the fat containing tissue of the BoT such that cooling the fat containing tissue of the BoT can induce temperature induced cell death of the lingual tonsils with and / or without adipose cell death at the fat containing tissue. Minimally invasive techniques can reduce patient discomfort after the procedure and can shorten overall patient recovery time. Additionally or alternatively, the inlet tube and the outlet tube of the tongue cryoprobe can direct heated fluid to and from an active surface of the applicator following administration of the temperature-controlled fluid. The thermal treatment unit can deliver heated fluid to the applicator to reduce thermal damage to the target area and / or non-target areas. For example, the thermal treatment unit delivers heated fluid to the applicator to remove ice formation on the target area before the patient experiences frostbite.
[0038] The applicator can further include a flexible circuit (e.g., conductor) electrically coupled to one or more temperature sensors on an active face of the applicator to monitor the thermal treatment of the tongue. In some embodiments, the tongue cryoprobe includes onboard electronics (e.g., in the applicator of the cry oprobe). The onboard electronics can process and convert measurements from the one or more temperature sensors, reducing the wires that are coupled to the tongue cryoprobe and / or the controller. Current methods for treating OSA with adipose cryolysis (i.e., controlled adipose cell death by cryolysis) can monitor temperature throughout treatment, however, most techniques use a secondary tool to monitor temperature. The secondary tool often includes additional wires that are coupled to the tool and / or the controller, which can congest the treatment area. By minimizing the additional wires within the sleep apnea treatment system, embodiments of the present technology reduce the likelihood of interference of sensitive equipment in the system, therebyenhancing user and patient safety throughout the treatment process. Additionally or alternatively, the onboard electronics can also reduce potential effects of electromagnetic interference on the analog measurements, provide flexibility to add or adjust measurements without changing the interface to the controller and / or provide the ability to change the type or characteristics of temperature sensors without changing the interface and / or the ability to individually calibrate temperature sensors in manufacturing.
[0039] In some embodiments, the controller receives signals from the temperature sensors to regulate the output of temperature-controlled fluid from the thermal treatment unit to the tongue cryoprobe. For example, if the sensors measure the surface temperature at the target area to be generally too high to cause adipose cell death by adipose cryolysis at a depth of 1 cm and / or cell death of surface lymphoid tissue (e.g., above a temperature between -30°C to 10°C), the controller can increase the flow rate of temperature-controlled fluid to the applicator of the tongue cryoprobe, thereby, optimizing cooling at the target area and reducing the likelihood of repeating treatment. The controller can further regulate the heating and / or chilling of fluid in the thermal treatment unit based on information from the temperature sensors and / or information input by the user, enhancing operational control throughout the procedure.
[0040] The conduit system can include a conduit (e.g., a corrugated tube) that houses an inlet fluid channel and an outlet fluid channel that are fluidically coupled to and facilitate transfer of a temperature-controlled fluid (e.g., the chilled and / or heated fluid) from the thermal treatment unit to the tongue cryoprobe. The conduit can include one or more spacers that maintain the position of the inlet and outlet channels within the conduit. In some fluid transfer systems, a fluid source can be fluidically coupled to a delivery device by external tubing; however, the external tubing are often longer fluid channels that overlap and crowd the treatment area. The conduit houses the inlet and outlet channels in a manner that prevents overlapping and kinking of tubing that can disrupt transfer of fluid. In addition, air between the conduit and the inlet and outlet fluid channels can provide insulation to the inlet and outlet fluid channels. The air insulation can allow the chilled and / or heated fluid to maintain its output temperature from the thermal treatment unit as it is transferred to the tongue cryoprobe, providing more efficient fluid delivery to the applicator, and thus, more efficient cooling of the target area.
[0041] Most of the current methods for treating OSA only target one site of airway obstruction (e.g., a tongue or soft palate). However, most individuals suffering from OSA have two or more sites of airway obstruction. To address this, the sleep apnea treatment system can include one or more cryoprobes that physicians can select to treat more than one site of airway obstruction (e.g., excess fat cells at the soft palate, lateral wall, epiglottis, etc.). For example, the physician can select a soft palate cryoprobc to treat the soft palate in addition to the tongue cryoprobe that treats the tongue, thereby reducing cells at more than one site of obstruction. In some embodiments, the cryoprobes selected can contact one or more anatomical elements that do not include excess fat cells (e.g., cells of the lingual tonsils, palatine tonsils, etc.). For example, the lingual tonsils are within the contact region of the tongue cryoprobe, and the surface temperature of the tongue applicator causes temperature induced cell death at the lingual tonsils. The physician can use both cryoprobcs sequentially in one procedure to reduce fat cell deposits and non-fat cell deposits (e.g., surface lymphoid tissue) at more than one target area. In some embodiments, patients with generally larger lingual tonsils may undergo more than one treatment session. For example, a first treatment session may reduce cells of the lingual tonsils but may not reach intra- lingual fat cell deposits. One or more subsequent treatment sessions can be done to reduce the fat cell deposits at the tongue. The present technology described herein can provide a more permanent solution to airway obstruction at various obstruction sites with lower surgical complication risks than other treatment methods. Furthermore, current treatment methods require OSA surgical specialists to perform the surgical procedures, due to their invasive techniques. In contrast, embodiments of the present technology described herein can broaden the number of physicians (e.g., general ENT surgeons, sleep physicians such as pulmonologists) able to perform the treatment, making the procedure more available to patients. The sleep apnea treatment system can also be cost-effective for patients since it is less expensive than a lifetime of CPAP. In summary, the sleep apnea treatment system and associated devices and methods described herein can be minimally invasive and customizable to improve patient outcomes without the painful recovery and morbidity associated with other OSA treatment methods.
[0042] In the Figures, identical reference numbers identify generally similar, and / or identical, elements. Many of the details, dimensions, and other features shown in the Figures are merely illustrative of particular embodiments of the present technology. Accordingly, other embodiments can have other details, dimensions, and features without departing from the spirit or scope of thedisclosure. In addition, those of ordinary skill in the art will appreciate that further embodiments of the various disclosed technologies can be practiced without several of the details described below.II. Methods and Systems for Treatment of Obstructive Sleep Apnea (OSA)
[0043] FIG. 1 shows a sleep apnea treatment system 100 (“system 100”) configured to treat a patient (P). The system 100 includes a thermal treatment unit 106, a cryoprobe 105 fluidically coupled to the thermal treatment unit 106, and a pump 104 fluidically coupled to the thermal treatment unit 106. The system 100 can further include a housing 130, a controller 122, one or more electrical lines 115 electrically coupling the controller 122 to the cryoprobe 105 and thermal treatment unit 106, a conduit 118 (e.g., a corrugated tube) fluidically coupling the thermal treatment unit 106 to the cryoprobe 105, and a fixation arm 112 mechanically coupled to the cryoprobe 105. As shown in FIG. 1, the thermal treatment unit 106, pump 104, and controller 122 can be disposed within the housing 130. The controller 122 can be operably coupled to the pump 104 to regulate fluid flow from the thermal treatment unit 106 to the cry oprobe 105 via the conduit 118. In some embodiments, the conduit 118 includes a generally longer inlet tube and outlet tube within the conduit 118 and coupling members 120a and 120b (collectively referred to as “coupling members 120”) at opposing ends of the conduit 118 that are fluidically coupled to the generally longer inlet tube, outlet tube, the thermal treatment unit 106, and / or cry oprobe 105. In some embodiments, the coupling members 120 incorporate a valve channel used to regulate (e.g., turn on and off) flow of the temperature-controlled fluid through the valve channel.
[0044] The cryoprobe 105 can further include an applicator 102 used to thermally treat (e.g., via direct contact) a target area interior or exterior to the oral cavity of the patient (P). The thermal treatment unit 106 can be fluidically coupled to the cry oprobe 105 such that the applicator 102 receives the temperature-controlled fluid via a generally shorter inlet tube and outlet tube. The temperature-controlled fluid can cool the applicator 102 to a temperature sufficient to thermally treat the target area. The applicator 102 can be further configured to extract heat from and / or deliver heat to the target area. More specifically, the applicator 102 can both remove and / or deliver heat at rates in a range of 0.2 Watts and 95 Watts, or any wattage therebetween (e.g., 5-20 Watts), for a period of 1 minute to 180 minutes, or any length of time therebetween. The applicator 102 and / or the cryoprobe 105 can vary based on the target area treated. For example, as described in more detail with referenceto FIGS. 4-5C, the applicator 102 includes a tapered tip to treat a tongue. In some embodiments, the fixation arm 112 holds the cryoprobe 105 adjacent to the patient (P) during treatment. Additionally or alternatively, the fixation arm 112 can be used to position and / or reposition the applicator 102 on the target area.
[0045] The thermal treatment unit 106 can be configured to store, generate, or produce a chilled or heated fluid via the pump 104 to the applicator 102 of the cry oprobe 105. For example, the thermal treatment unit 106 is a simpler refrigerant chiller that cools the temperature-controlled fluid. Additionally or alternatively, the thermal treatment unit 106 can be a Peltier device coupled directly or indirectly to the applicator 102 of the cryoprobe 105. The Peltier device can chill the temperature- controlled fluid directed toward the applicator 102. In some embodiments, a secondary loop of the temperature-controlled fluid cools the Peltier device. Additionally or alternatively, the thermal treatment unit 106 can include a heating device configured to provide a heated gas or fluid to the applicator 102. In some embodiments, the thermal treatment unit 106 includes separate components (e.g., a heater and a chiller) fluidically coupled to the conduit 118 to deliver and / or remove the temperature-controlled fluid from the thermal treatment unit 106 and the applicator 102 of the cryoprobe 105. The configuration of the thermal treatment unit 106 can be described in more detail with reference to FIG. 2.
[0046] The controller 122 can be configured to control the overall operation of the system 100. The user or a computer / CPU system can operate the controller 122. In some embodiments, the controller 122 controls and / or stabilizes the temperature of the thermal treatment unit 106, prompts the user for the next step of a procedure (such as switching from cooling to heating), and issues warnings when temperature measurements are out of range, requiring manual input to change the incorrect parameters. Additionally or alternatively, the controller 122 can turn on / off the pump 104 and / or manages the speed (e.g., RPM) of the pump 104. In some embodiments, an RPM counter monitors fluid flow rate during a given thermal treatment session. For example, if the tissue temperature is warmer than the desired one, then the user or the system 100 increases the fluid flow rate by increasing the RPM of the pump 104, which increases the heat extraction rate and decreases the temperature at the target area. Conversely, the user or the system 100 can reduce the RPM of the pump 104 to decrease the heat extraction, thereby increasing the temperature at the target area. The user can increase or reduce the RPM using the controller 122. The controller 122 can run operationsof the sleep apnea treatment system 100 based on measurement and guidance systems within the system 100. For example, the measurement system includes one or more sensors located on or within the devices of the system (e.g., the thermal treatment unit 106 and / or the cryoprobe 105). The measurement system can further be used to collect information related to fluid flow rate, fluid pressure, temperatures of the thermal treatment unit 106 and / or applicator 102, pressure of the applicator 102 on the target area, contact detection, etc. In some embodiments, the controller 122 outputs data from the measurement system for interpretation by the user on a display. Additionally or alternatively, the data acquired during the procedure can be stored in a storage device (e.g., an external hard drive).
[0047] FIG. 2 shows a thermal treatment unit 200 (e.g., the thermal treatment unit 106 of FIG. 1). The thermal treatment unit 200 can include a heater 201, a chiller 202, enclosures 203a and 203b (referred to collectively as “enclosures 203”), a warming tank 204, and a cooling tank 208. The warming tank 204 and the cooling tank 208 can each be filled with temperature-controlled fluid and fluidically coupled to fluid lines 205 that dispense the temperature-controlled fluid to a cryoprobe (e.g., the cryoprobe 105 of FIG. 1). The thermal treatment unit 200 can further include a valve 206 used to switch between administration of different fluids (e.g., a chilled fluid and / or a heated fluid). In some embodiments, the warming tank 204 and / or the cooling tank 208 are made of a highly conductive material (e.g., metal). The heater 201 (e.g., a submerged heater) and the chiller 202 (e.g., an immersion coil of a chiller) can be disposed within the warming tank 204 and the cooling tank 208, respectively. The enclosures 203 can surround the warming tank 204 and / or the cooling tank 208, e.g., to improve efficiency thereof. The enclosure 203a can further be fluidically coupled to an exhaust line 207 that feeds exhaust from the chiller 202 to the enclosure 203a, thereby allowing the thermal energy produced by the chiller 202 to heat the warming tank 204, in addition to the heater 201. The enclosures 203 can be made of material with a higher R-value or greater resistance to heat flow (e.g., fiberglass or polystyrene). In some embodiments, the enclosures 203 are vacuum insulation. For example, the cooling tank 208 is vacuum insulated to reduce the large temperature differential between the air surrounding the cooling tank (e.g., at room temperature) and the chilled fluid.
[0048] The warming tank 204 and / or the cooling tank 208 can further include lids that cover the tanks and / or agitators disposed within the tanks to maximize convective heat transfer between thetemperature-controlled fluid and the heater 201 and the chiller 202, respectively. It is worth noting that the heater 201 can also be one or more flexible heaters that wrap around the outside of the warming tank 204 to warm the temperature-controlled fluid. Additionally or alternatively, the flexibles heaters can be surrounded by the enclosure 203a and / or another form of insulation to increase convective heat transfer. It can be advantageous for the thermal treatment unit 200 to include both the heater 201 and the chiller 202 so that the thermal treatment unit 200 can provide relatively rapid warming to the target area. In some embodiments, the cooling tank 208 reduces the temperature of the fluid that enters the applicator, which in turn can remove heat from the target area and causes adipose cryolysis of tissue at the target area. For example, the heat-treated fluid is between -40°C and -10°C or any temperature therebetween, or at most -40°C, -30°C, -20°C, and -10°C. Additionally or alternatively, the fluid can be cycled through the warming tank 204 to rapidly warm the applicator after cold treatment, and thereby warm the mucosa membrane at the target area to reduce damage associated with cooling during thermal treatment. Damage associated with cooling can include hypothermia, frostbite, cold burns, nerve damage, and / or the like. Although embodiments of the present technology are directed towards inducing adipose cryolysis by use of a temperature-controlled fluid, adipose cryolysis can also be achieved using embodiments of the present technology and one or more additional methods of thermal treatment (e.g., thermoelectric cooling and / or warming).III. Tongue Cryoprobes for Treatment of OSA
[0049] FIG. 3 shows a tongue cryoprobe 300 (e.g., the probe 105 of FIG. 1) that can include a handle 305 and an applicator 350. The handle 305 can include an arm 310, an inlet tube 325, and an outlet tube 345. The tongue cryoprobe 300 can include one or more electrical lines 315 that electrically couple the tongue cryoprobc 300 to a controller (e.g., the controller 122 of FIG. 1). The electrical lines 315 can be electrically coupled to one or more electrical components of the tongue cryoprobe 300, e.g., to transmit signals from the electrical components of the tongue cryoprobe 300 to the controller and / or provide power from the controller to the electrical components, as described in more detail with reference to FIGS. 4, 12A, and 12B. In some embodiments, the inlet tube 325 and the outlet tube 345 include proximal ends 320, 340, respectively. A coupling member (e.g., the coupling member 120a of FIG. 1) can be coupled to the proximal ends 320, 340 and a conduit (e.g., the conduit 118 of FIG. 1).
[0050] The tongue cryoprobe 300 can further include coupling members 355a and 355b (collectively referred to as “coupling members 355”). In some embodiments, the coupling members 355 extend from a distal portion and / or a distalmost pail of the inlet tube 325 and the outlet tube 345, and mate and / or align with a proximal end of the applicator 350. An angle al between the proximal ends 320 and 340 and the distal portions and / or the distalmost portions of the inlet tube 325 and the outlet tube 345 and / or the coupling members 355, can be between 70° and 90°, any angle therebetween, or at least 70°, 80°, or 90°. In some embodiments, the angle al is configured such that axes extending through the proximal ends 320 and 340 along a proximal portion of the inlet tube 325 and the outlet tube 345 are generally parallel to a vertical axis of the arm 310. Additionally or alternatively, the angle al can be configured such that when the applicator 350 is in the oral cavity of a patient, a face of the applicator 350 is in contact with the tongue of the patient and a distal tip of the applicator 350 reaches the vallecula of the patient, as described in more detail with reference to FIGS. 5A-5D.
[0051] The coupling members 355 are described in more detail with reference to FIG. 11. An insulator 335 can be coupled to one or more sides of the applicator 350, as described in more detail with reference to FIGS . 15 and 16. The tongue cryoprobe 300 can further include one or more working channels 360a and 360b (collectively referred to as “working channels 360”) coupled to a channel assembly base 362. In some embodiments, one or more couplers 363 (e.g., hinges, pivots, joints, etc.) mechanically couple the channel assembly base 362 to the arm 310 and / or to the applicator 350. The working channels 360 and the channel assembly base 362 arc described in more detail with references to FIGS. 17 and 18A-18B, respectively.
[0052] The arm 310 can include a triggering mechanism 313 and a support interface 317. The support interface 317 can be designed to interface with an off-the-shelf equipment support system (e.g., FISSO articulated arm). Additionally or alternatively, the support interface 317 and can be coupled to a positioning arm (e.g., the fixation arm 112 of FIG. 1) that holds the tongue cryoprobe 300 adjacent to the patient during treatment. In some embodiments, the triggering mechanism 313 releases the aim 310 from a charged state to an activated state. In the activated state, the aim 310 can provide traction to the tongue cryoprobe 300 that in turn creates traction between the applicator 350 and the tongue of the patient throughout treatment, as described in more detail with reference to FIGS . 19A and 19B.
[0053] The working channels 360 (e.g., working channels 1760, 1860 of FIGS. 17-18B) can guide working instruments to the tongue to monitor conditions at the tongue during insertion and / or throughout treatment. For example, working instruments include suction tubes and / or endoscopes that aid in tongue visualization throughout treatment, as described in more detail with reference to FIG. 23D.
[0054] FIG. 4 shows the applicator 350 of the tongue cryoprobe 300 of FIG. 3. The applicator 350 can include a base component 451 (e.g., a first component), and a treatment component 452 (e.g., a second component) coupled to the base component 451 such that the applicator 350 can withstand fluid pressure from the temperature-controlled fluid, preventing leakage throughout thermal treatment. The applicator 350 can further include an active face 457 and a tapered tip 461 at a distal end of the applicator 350. For example, a width of the active face 457 can decrease in a distal direction such that a first width of the active face 457 at a proximal region thereof is greater than a second width of the active face 457 at an intermediate region thereof, and the second width is greater than a third width of the active face 457 at a distal region thereof. In some embodiments, a height or thickness of the applicator 350 (i.e., the base component 451 and / or the treatment component 452) can decrease (i.e., become thinner) in the distal direction, such that a first thickness of the applicator 350 at a proximal region thereof is greater than a second thickness of the applicator 350 at an intermediate region thereof, and the second thickness is greater than a third thickness of the applicator 350 at a distal region thereof.
[0055] The active face 457 can be an active surface configured to be in thermal contact with the tongue (e.g., the BoT, lingual tonsils, etc.). For example, the active face 457 can have a curvature that is shaped to conform to and / or complement the tongue such that temperature-controlled fluid distributes evenly throughout the applicator 350. The tapered tip 461 can be tapered to improve placement of the applicator 350 at the tongue. The inlet tube 325 and outlet tube 345 can be configured to deliver the temperature-controlled fluid to the applicator 350. More specifically, one or more collars or coupling members 355a and 355b (referred to collectively as “coupling members 355”) can be coupled the inlet tube 325, the outlet tube 345, and the applicator 350 such that the inlet tube 325 and the outlet tube 345 are fluidically coupled to the applicator 350.
[0056] The applicator 350 can further include a flexible circuit 460 (e.g., a conductor) and / or one or more sensors 470 at and / or on the active face 457. In some embodiments, the active face 457includes an indented portion shaped and / or sized to receive the flexible circuit 460. As shown in FIG. 4, the wiring for the sensors 470 can come from the flexible circuit 460. The flexible circuit 460 can span the active face 457 over an edge 459 of the treatment component 452 and / or the insulator 335 into the base component 451. As described in more detail with reference to FIGS. 12A and 12B, the flexible circuit 460 can be electrically coupled to the sensors 470 and other electrical components incorporated into the applicator 350. The tongue cryoprobe 300 can include onboard electronics that process and convert measurements from the one or more temperature sensors, reducing the wires that couple the tongue cryoprobe 300 to the controller (e.g., the controller 122 of FIG. 1), thereby reducing the equipment around the patient throughout the surgical procedure.
[0057] In some embodiments, the sensors 470 are temperature sensors (e.g., thermistors), that record temperature measurements at the active face 457. The flexible circuit 460 and the sensors 470 can monitor temperature at the target area to maintain cryolitic conditions that can induce adipose cell death by adipose cryolysis and / or cell death of surface lymphoid tissue (e.g., temperatures between - 30°C and 10°C) and / or to prevent damage associated with excess cooling at the target area. More specifically, the sensors 470 can be electrically coupled to the controller such that controller can change the flow rate of temperature-controlled fluid flowing to the applicator 350 based on the temperature received. For example, if the sensors 470 measure the temperature of the active face 457 is generally too high to cause adipose cell death by adipose cryolysis at a depth of 1 cm and / or cell death of surface lymphoid tissue (e.g., above a temperature between -30°C to 10°C), the flow rate of the temperature-controlled fluid to the applicator 350 is increased to maintain a target surface temperature between -30°C to 10°C, or any temperature therebetween. In some embodiments, it is advantageous to monitor temperature at the tongue to prevent damage associated with excess cooling at the target area, thereby, increasing the patient’s likelihood of a generally faster recovery. Additionally or alternatively, the sensors 470 can include pressure sensors or contact sensors attached to the active face 457 used to ensure the applicator 350 is making even contact with the tongue. For example, the system (e.g., the system 100 of FIG. 1) monitors contact data readings from one or more pressure sensors or contact sensors on the applicator 350 to ensure the active face 457 is making even contact with the tongue, thereby, optimizing cooling at the target area throughout thermal treatment. In some embodiments, the flexible circuit 460 and the sensors 470 are incorporated onto the insulator335. For example, pressure sensors and / or contact sensors are attached to the insulator 335 to ensure that the insulator 335 is making even contact with the area surrounding the tongue.
[0058] In some embodiments, the user positions the active face 457 of the applicator 350 along the midline of the target area. However, exact placement of the active face 457 can change dependent on the patient’s needs. In operation, the lower the surface temperature at the target area, the greater depth of cooling achieved. In some embodiments, the system can operate at a time and temperature that allows the surface temperature of the target area to reach 10°C for at least 15 minutes. For example, when treating the tongue, cooling the target area to 10°C for at least 15 minutes creates a transmural cooling that can cause adipose cryolysis of adipose cells at the target area and / or temperature induced cell death of surface lymphoid tissue (e.g., lingual tonsils, palatine tonsils, etc.) at the target area. Thus, the system can reduce a volume of adipose cells and non-adipose cells at the target area without the use of invasive surgical techniques. It is worth noting that although example treatment times, surface temperatures, and depths of cooling are provided herein, the depth of cooling at the tongue can differ between patients depending on various patient factors (e.g., muscle concentration, blood flow, etc.). The temperature of the temperature-controlled fluid, the target surface temperature, and / or the thermal treatment time can be customized based on the depth of cooling required to treat the patient’s condition. Thus, the system can reduce a volume of adipose cells at the target area without the use of invasive surgical techniques.
[0059] The base component 451 and / or the treatment component 452 can be made of metal, polymers, or other materials (e.g., aluminum, stainless steel, polyphenylene sulfide (PPS), plastic, and / or nitinol) suitable for contacting the oropharyngeal area. In some embodiments, the base component 451 and the treatment component 452 are made of the same material. Additionally or alternatively, the base component 451 and the treatment component 452 can be made of different materials, as described in more detail with reference to FIG. 10.
[0060] FIGS. 5A-5D show various views of an applicator 550 with a tapered tip 561, in accordance with embodiments of the present technology. Specifically, FIGS. 5A and 5B show isometric views of the applicator 550, FIG. 5C shows a side view of the applicator 550, and FIG. 5D shows a top view of the applicator 550. The applicator 550 can include any features or functionality of the applicator 350 of FIG. 4. The applicator 550 shown in FIGS. 5A-5D omits certain features of the applicator 350 shown in FIG. 4 solely for clarity and visualization purposes.
[0061] As shown in FIGS. 5A and 5B, the tapered tip 561 can be at a distal end 558 of the applicator 550. The applicator 550 can further include an inlet 525 and an outlet 545 at a proximal end 556 of the applicator 550. The inlet 525 can be fluidically coupled to an inlet tube (e.g., the inlet tube 325 of FIG. 4) and the outlet 545 can be fluidically coupled to an outlet tube (e.g., the outlet tube 345 of FIG. 4). The inlet 525 and the outlet 545 can respectively receive and remove the temperature- controlled fluid from the applicator 550. The applicator 550 can be hollow such that the temperature- controlled fluid can enter through the inlet 525, distribute throughout the applicator 550, and exit through the outlet 545, as described in more detail with reference to FIGS. 6-8.
[0062] Referring to FIG. 5A, the applicator 550 can include an active face 557. The active face 557 can include any features or functionality of the active face 457 of the applicator 350 of FIG. 4. As shown in FIG. 5A, the active face 557 can include one or more widths (W1-W4) that gradually decrease in size in a distal direction towards the tapered tip 561, i.e., from the proximal end 556 toward the distal end 558. The width (Wl) can have a width between 25 mm to 35 mm or any width therebetween, or at most 25 mm, 30 mm, or 35 mm. The width (W2) can have a width between 20 mm to 33 mm or any width therebetween, or at most 20 mm, 26.5 mm, or 33 mm. The width (W3) can have a width between 15 mm to 25 mm or any width therebetween, or at most 15 mm, 20 mm, or 25 mm. The width (W4) can have a width between 10 mm to 20 mm or any width therebetween, or at most 10 mm, 15 mm, or 20 mm. The widths (W1-W4) can be generally large enough to provide contact coverage to a majority of the tongue, and be tapered towards the tapered tip 561 at the vallecula of the patient. While decreasing the widths (W1-W4) towards the distal end 558 decreases the treatment surface area of the active face 557 relative to an applicator that maintains a width generally equivalent to Wl towards the distal end 558, the tapered profile also enables the active face 557 and applicator 550 generally to be more appropriately (e.g., blindly and intuitively) placed into the depths of the vallecula of the patient. The treatment surface area ranges of the applicator 550 are described in more detail with reference to FIG. 5D. Additionally, an applicator that is narrower and not tapered (e.g., an applicator that has a width less than Wl that is generally consistent from the proximal end 556 towards the distal end 558) does not increase maneuverability of the applicator, as one would expect. Rather, an applicator featuring the tapered tip 561 formed by decreasing the widths (W1-W4), and consequently, creating a lower profile at the distal end 558, can increase the likelihood of successful placement at the target area.
[0063] Referring to FIG. 5B, the applicator 550 can include a back face 575 opposite the active face 557 of FIG. 5A and one or more attachment points 577a and 577b (referred to collectively as “attachment points 577”) that can each independently extend from the back face 575. The attachment points 577 can be at an intermediate portion (e.g., center) of the applicator 550. In some embodiments, the attachment points 577 are at a distance (DI) between 10 mm and 40 mm (e.g., 10 mm, 25 mm, 40 mm, etc.) or any distance therebetween, or at most 10 mm, 25 mm, or 40 mm from the tip 561. Additionally or alternatively, the attachment point 577 can be at a distance (D2) between 10 mm and 40 mm or any distance therebetween, or at least 10 mm, 25 mm, or 40 mm from the inlet 525 and / or the outlet 545. In some embodiments, the D2 is greater than DI. The attachment points 577 can be coupled to one or more couplers (e.g., the one or more couplers 363 of FIG. 3), and the one or more couplers can be coupled to a channel assembly base (e.g., the channel assembly base 362 of FIG. 3). The channel assembly base 362 is described in more detail with references to FIGS. 17 and 18A-18B. The attachment points 577 can be positioned on the back face 575 such that the pressure applied to the applicator 550 does not cause the applicator 550 to move and / or deform during insertion and / or throughout treatment. For example, in part because the attachment points 577 are positioned a distance (DI) from the distal tip 561 and / or a distance (D2) from the outlet 545, in operation, the attachment points 577 can allow the normal force generated when applying the applicator 550 to the target area to be distributed evenly across the active face of the applicator 550, thereby maintaining an even pressure across the target area of the patient. This can optimize cooling at the target area throughout thermal treatment and shorten the overall procedure. Additionally or alternatively, the position of the attachment points 577 can also ensure the attachment points 577 do not increase the overall height of the applicator, as described in more detail with reference to FIG. 5B.
[0064] FIG. 5C shows a side view of the applicator 550 of FIG. 5A. The applicator 550 can further include one or more heights (H1-H5) that gradually decrease in size in a distal direction, i.e., from the proximal end 556 toward the distal end 558. The height (Hl) can have a height between 5 mm to 13 mm or any height therebetween, or at most 5 mm, 8 mm, or 13 mm. The height (H2) can have a height between 2 mm to 10 mm or any height therebetween, or at most 2 mm, 6 mm, or 10 mm. The height (H3) can have a height between 2.25 mm to 10 mm or any height therebetween, or at most 2.25 mm, 7 mm, or 10 mm. The height (H4) can have a height between 2 mm to 10 mm or any height therebetween, or at most 2 mm, 7 mm, or 10 mm. The height (H5) can have a heightbetween 1.75 mm to 10 mm or any height therebetween, or at most 1.75 mm, 5 mm, or 10 mm. Hl can be generally greater than H2-H5 so that the inlet 525 and the outlet 545 can be coupled to the coupling members (e.g., the coupling members 355 of the tongue cryoprobe 300 of FIG. 3). A height (H6) can be at an intermediate portion of the applicator 550 (e.g., at the attachment points 577 of FIG. 5B) and can be between 3 mm and 6 mm or any height therebetween that does not increase the overall height of the applicator 550, increasing the user’s ability to maneuver the applicator onto the tongue, especially for patients with an abundance of tissue or anatomic constraints in the oropharynx (e.g., female patients), and thus reduces the time spent positioning the tongue cryoprobe and the length of the surgical procedure.
[0065] The applicator 550 can also include an arc length (LI) along the active face 557. In some embodiments the active face 557 is an active face (e.g., the active face 457 of FIG. 4) thermally coupled to the tongue for thermal treatment. The curvature of the active face 557 can be shaped to conform and / or complement the shape of the tongue and / or to increase effective surface area contacting the tongue. In some embodiments, the active face 557 is smooth, and / or has texture that increases surface area contact and / or holds the applicator 550 in place throughout thermal treatment. As shown in FIG. 5C, the concavity or curvature can increase in a distal direction along the arc length (LI), such that the active face 557 along the arc length (LI) has a greater concavity and curvature at the distal end 558 than at the proximal end 556. The arc length (LI) can be between 45 mm and 65 mm or any length therebetween that reaches the patient’s vallecula, or at least 45 mm, 50 mm, 55 mm, 60 mm, 65 mm. For example, an increase in concavity along the arc length (LI) indicates that the curvature of the active face 557 becomes more pronounced in a distal direction, resulting in a tighter or sharper bend toward the distal end 558 compared to the proximal end 556 of the applicator, thereby enabling the applicator 550 to reach the patient’s vallecula. As shown in FIGS. 5 A and 5B, the outlet 545 (and the inlet 525 of FIGS. 5A and 5B) is at the proximal end 556 of the applicator 550, which advantageously can reduce the overall height and profile of the applicator 550, thereby making it easier to place the applicator 550 underneath the epiglottis and on the tongue for thermal treatment. As shown in FIG. 5C, the inlet 525 and the outlet 545 can increase the overall length of the applicator 550 to an arc length (L2), which can be between 50 mm to 70 mm or any arc length therebetween, or at least 50 mm, 60 mm, or 70 mm. In some embodiments, the arc lengths (LI andL2) are generally long enough such that the distal end 558 reaches the base of the vallecula to facilitate placement of the applicator 550 on the tongue.
[0066] FIG. 5D shows a top view of the applicator 550 of FIG. 5A. As shown in FIG. 5D, the inlet 525 and the outlet 545 can extend into the applicator 550 such that the temperature-controlled fluid can be distributed evenly throughout the applicator 550, for example, by one or more flow paths, as described in more detail with reference to FIGS. 6-8. The applicator 550 can include a width (Wl) between 25 mm to 35 mm, or any width therebetween. W 1 can be no more than 35 mm such that the applicator 550 can fit within the oral cavity. In some embodiments, Wl is generally wide enough to maximize the surface area between the active face of the applicator 550 (e.g., the active face 557 of FIG. 5A and 5C and / or the active face 457 of FIG. 4) and the tongue while maintaining the tapered tip 561 at the distal end 558. Wl can be generally wide enough such that the surface area contacting the tongue is between 14 cm2to 18 cm2, or any surface area therebetween. In some embodiments, the thickness of insulation (e.g., the insulator 335 of FIG. 3) on the applicator 550 is reduced to reduce the overall width of the applicator 550. The applicator insulator is described in more detail with reference to FIGS. 3, 15, 16, and 18A-18C.
[0067] FIG. 6 shows a hollow cavity 692 of a treatment component 652 with a flow path design.The hollow applicator 652 can include any features or functionality of the treatment component 452 of the applicator 350, as described in more detail with reference to FIG. 4. The treatment component 652 can include an inlet 625, an outlet 645, and an active face 657. The treatment component 652 can further include one or more protrusions or baffles 690a, 690b, 690c (collectively referred to as “protrusions 690”). The protrusions 690 can form one or more flow paths 695a, 695b, 695c, 695d (collectively referred to as “flow paths 695”). As shown in FIG. 6, the flow paths 695 can be U- shaped channels that can direct temperature-controlled fluid from the inlet 625 to the outlet 645 in a U-shaped manner. Stated differently, the protrusions 690 can be arranged to define the flow paths 695, such that individual protrusions 690 are parallel to one another and individual flow paths 695 are parallel to one another. In some embodiments, the height of the protrusions 690 is between 2 mm and 3 mm or any height therebetween, or at most 2 mm, 2.5 mm, or 3 mm, and the average length of the protrusions 690 is between 40 mm and 1 15 mm or any length therebetween, and or most 40 mm, 75 mm, or 115 mm. In some embodiments, the average width of the flow paths 695 is between 1.5 mm and 3.5 mm or any width therebetween, or at most 1.5 mm, 2.5 mm, or 3.5 mm. In someembodiments, the height of the protrusions 690, and thus the height of the flow paths 695, are consistent along a length towards the distal end 658 of the hollow applicator 652. The flow paths 695 can allow the temperature-controlled fluid to flow at a relatively constant rate within the treatment component 652 without generally large fluctuations in the pressure and / or flow rate thereby minimizing the temperature variations on the active face of the applicator (e.g., the active face 457 of FIG. 4) to provide uniform heat extraction from the target area. Doing so cools the target area to a predeteimined depth, and therein reduces the likelihood of repeated thermal treatments.
[0068] FIG. 7 shows a hollow cavity 792 of a treatment component 752 with another flow channel design. The treatment component 752 can include any features or functionality of the treatment component 452 of the applicator 350, as described in more detail with reference to FIG. 4. The treatment component 752 can include an inlet 725, an outlet 745, and an active face 757. The treatment component 752 can further include one or more protrusions 790 in a cross-fin design. The treatment component 752 can include any features or functionality of the treatment component 652 of FIG. 6, except that the protrusions 790 are in a cross-fin design. The protrusions 790 can form one or more flow paths 795. As shown in FIG. 7, the flow paths 795 can direct temperature-controlled fluid from the inlet 725 across the width of the treatment component 752 and to the outlet 745. In some embodiments, the height of the protrusions 790 is between 2 mm and 3 mm or any height therebetween, or at most 2 mm, 2.5 mm, or 3 mm, and the average length of the protrusions 790 is between 5 mm and 28 mm or any length therebetween, or most 5 mm, 16 mm, or 28 mm. In some embodiments, the average width of the flow paths 795 is between 1.5 mm and 3.5 mm or any width therebetween, or at most 1.5 mm, 2.5 mm, or 3.5 mm. In some embodiments, the height of the protrusions 790, and thus the height of the flow paths 795, are consistent along a length towards the distal end 758 of the hollow applicator 752. In some embodiments, the protrusions 790 promote even flow of the temperature-controlled fluid through the flow paths 795 and on both halves of the treatment component 752. Additionally or alternatively, the protrusions 790 can direct temperature- controlled fluid through the flow paths 795 to promote even distribution of cooling temperatures across the active face 757, cooling the target area to a predetermined depth, and thus, reducing the likelihood of repeated thermal treatment.
[0069] FIG. 8 shows a hollow cavity 892 of a treatment component 852 with a serpentine flow channel design. The treatment component 852 can include any features or functionality of thetreatment component 452 of the applicator 350, as described in more detail with reference to FIG. 4. The treatment component 852 can include an inlet 825, an outlet 845, and an active face 857. The treatment component 852 can further include one or more protrusions 890 configured in a serpentine design. In some embodiments, the protrusions 890 extend from a proximal end 856 of the treatment component 852 towards the center of the treatment component 852. Additionally or alternatively, the protrusions 890 can extend from a distal end 858 of the treatment component 852 towards the center of the treatment component 852. The treatment component 852 can include any features or functionality of the hollow applicators 652 and 752 of FIGS. 6 and 7, except that the protrusions 890 are in a serpentine design. The protrusions 890 can form one or more flow paths 895. As shown in FIG. 8, the flow paths 895 can direct temperature-controlled fluid from the inlet 825 along a serpentine flow path to the outlet 845. In some embodiments, the height of the protrusions 890 is between 2 mm and 3 mm or any height therebetween, or at most 2 mm, 2.5 mm, or 3 mm, and the average length of the protrusions 890 is between 10 mm and 50 mm or any length therebetween, and or most 10 mm, 35 mm, or 50 mm. In some embodiments, the average width of the flow paths 895 is between 3 mm and 10 mm or any width therebetween, or at most 3 mm, 6.5 mm, or 10 mm. In some embodiments, the height of the protrusions 890, and thus the height of the flow paths 895, are consistent along a length towards the distal end 858 of the hollow applicator 852. In some embodiments, the protrusions 890 promote even flow of the temperature-controlled fluid through the flow paths 895 and on both halves of the treatment component 852. Additionally or alternatively, the protrusions 890 can direct temperature-controlled fluid through the flow paths 895 to promote even distribution of cooling temperatures across the active face 857, cooling the target area to a predetermined depth, and thus, reducing the likelihood of repeated thermal treatment.
[0070] FIG. 9 shows an applicator 950 including a base component 951 and a treatment component 952 combined using a heat cure adhesive. The base component 951 and treatment component 952 can include any of the features and functionality of the respective base components and treatment components described elsewhere herein. The base component 951 can include one or more depressions 907a-907d (referred to collectively as “depressions 907”). The treatment component 952 can include one or more protrusions 917a-917d (referred to collectively as “protrusions 917”). The protrusions 917 can be configured to mate with the depressions 907 when the treatment component 952 is combined with the base component 951. In some embodiments, the userapplies a heat cure adhesive to the depressions 907 and / or to the protrusions 917 to combine the base component 951 and the treatment component 952 together. In some embodiments, the user applies the heat cure adhesive to various areas of the base component 951 and the treatment component 952 apart from the depressions 907 and protrusions 917. Additionally or alternatively, the base component 951 and / or treatment component 952 can omit the depressions 907 and / or the protrusions 917, respectively, and the user can apply a heat cure adhesive directly to one or more edges of the base component 951 and / or the treatment component 952 to combine the components together. The heat cure adhesive can use a UV curing process to bond the base component 951 to the treatment component 952. UV curing can be generally faster than temperature and / or air bonding and can be easier to validate (i.e., ensuring a reliable, consistently strong bond between the two components). In some embodiments, UV curing includes various visualization checks that allow the user to visualize the adhesive has cured. For example, the adhesive is fluorescent once cured. Additionally or alternatively, the base component 951 and the treatment component 952 can be combined by one or more coupling mechanisms including joints, screws, pins, fasteners, and / or the like. However, mechanical coupling mechanisms can be prone to leakage in designs that are generally thin since the couplers can puncture one or both the base component 951 and the treatment component 952. It can be advantageous to use a heat cure adhesive over mechanical coupling mechanisms to reduce the overall height of the applicator and to prevent leakage, simplifying placement of the applicator 950 at the target area while increasing patient safety.
[0071] FIG. 10 shows an applicator 1050 with a base component 1051 and a treatment component 1052 made of similar or dissimilar materials. The base component 1051 and / or the treatment component 1052 can be machined, three-dimensionally printed, and / or casted out of a metal or other materials (e.g., aluminum, plastic, stainless steel, and / or nitinol) suitable for contacting the tongue. In some embodiments, the base component 1051 is made of a plastic polymer (e.g., polycarbonate (PC), Acrylonitrile Butadiene Styrene (ABS), Ultem, polyphenylsulfone (PPSU), polysulfone, and / or polyacrylamide), and the treatment component 1052 is made of a metal (e.g., aluminum). It can be advantageous to make the base component 1051 out of a plastic and the treatment component 1052 out of a metal since metals generally have a higher coefficient of thermal conductivity, and plastics generally have a lower coefficient of thermal conductivity. The difference in thermal conductivity coefficients ensures that more of the heat transfer between the temperature-controlled fluid within the applicator 1050 and the tongue occurs at an active face of the treatment component 1052 (e.g., the active face 457 of the treatment component 452 of FIG. 4). This improves the heat transfer efficiency of the applicator 1050 while also imparting an insulating effect to the active face, thereby reducing the need for extra insulating layers, such as a foam, and in turn, decreasing the overall size of the applicator 1050. Utilizing a plastic for the base component 1051 can also allow the base component 1051 to be made with injection molding, which reduces costs and allows for rapid mass manufacturing of parts.
[0072] The base component 1051 can include a translucent plastic (e.g., PPSU) such that a UV curing process can combine the base component 1051 and the treatment component 1052 together, as described in more detail with reference to FIG. 9. Additionally or alternatively, it can be advantageous to have the base component 1051 made of a plastic that has a thermal expansion coefficient similar to the material used on the treatment component 1052. For example, PPSU has a coefficient of thermal expansion generally similar to aluminum, and thus, if the base component 1051 and the treatment component 1052 are temperature cycled, they will experience similar deformation. If the base component 1051 and the treatment component 1052 are made of two materials that have dissimilar coefficients of thermal expansion, then the base component 1051 and the treatment component 1052 can deform, the adhesive can loosen, and / or cracks can form in the components. If the adhesive of the applicator 1050 loosens or cracks form in the components, temperature-controlled fluid can leak out of the applicator 1050 and can cause the patient harm. In some embodiments, the base component 1051 and the treatment component 1052 arc also unaffected by the temperature-controlled fluid administered to the applicator 1050. For example, aluminum and PPSU are unaffected by the temperature-controlled fluid (e.g., ethanol, glycerol, etc.).
[0073] FIG. 11 shows an applicator 1150 coupled to an inlet tube 1125 and an outlet tube 1145 using a coupling mechanism 1100. The applicator 1150, the inlet tube 1125, and the outlet tube 1145 can include any features or functionality of the applicators, inlet tubes, and outlet tubes (e.g., the applicator 350, the inlet tube 325, and the outlet tube 345 of FIG. 3, respectively) described herein. The coupling mechanism 1100 can include ferrules 1130a and 1130b (referred to collectively as “ferrules 1 130”) and coupling members 1 155a and 1155b (referred to collectively as “coupling members 1155”). As shown in FIG. 11, the ferrule 1130b can be within the outlet tube 1145. It is worth noting that although FIG. 11 only shows the ferrule 1130b within the outlet tube 1145, agenerally identical ferrule 1130a can be within the inlet tube 1125. The inlet tube 1125 and the outlet tube 1145 can fluidically couple the applicator 1150 by the coupling members 1155 and the ferrules 1130. The coupling members 1155 can include any features or functionality of coupling members 355 of FIG. 3. The coupling members 1155 can include a first cross-sectional dimension (D3) and the ferrules 1130 can include a second cross-sectional dimension (D4). In some embodiments, D3 is between 8.5 mm and 10.5 mm or any cross-sectional dimension therebetween, or at most 8.5 mm, 9.5 mm, and 10.5 mm, and D4 is between 2 mm and 7 mm or any cross-sectional dimension therebetween, or at most 2 mm, 4.5 mm, and 7 mm. In some embodiments, D3 is generally small enough such that the inlet tube 1125 and the outlet tube 1145 can fit within the coupling members 1155, and D4 can be generally small enough such that the ferrules 1130 can fit within the inlet tube 1125 and the outlet tube 1145. In some embodiments, the ferrules 1130 arc ovalizcd, meaning the ferrule 1130 as well as the coupling member 1155 can have an oval shape in which the cross-sectional dimension perpendicular to the applicator 1150 is minimized. This can minimize the overall height profile, or envelope, of the applicator 1150, and thus improve the overall fit of the applicator 1150 in the patient’s oral cavity.
[0074] In some embodiments, the coupling members 1155 have a height (H7) between 3 mm and 5 mm, or any height therebetween. As described in more detail with reference to the applicator 550 of FIGS. 5A-5C, the applicator 1150 can be generally thin and tapered (e.g., decreasing in height) from a proximal end 1156 to a distal end 1158. H7 can be generally the same height as Hl of FIG. 5B. In doing so, the coupling members 1155 do not increase the overall height of the applicator 1150 significantly. Furthermore, the coupling members 1155 can be coupled to the proximal end 1156 of the applicator 1150 for similar reasons. It can be advantageous to decrease the overall height of the applicator 1150 to increase the maneuverability of the cryoprobe (e.g., the tongue cryoprobe 300 of FIG. 3) into the target area, thereby simplifying placement of the applicator. In some embodiments, the coupling members 1155 can be coupled to the proximal end 1156 of the applicator 1150 such that the user can pull the inlet tube 1125 and the outlet tube 1145 through the coupling members 1155, wedging the ferrules 1130 into place and creating a mechanical (i.e., adhesive less) attachment between the tubes and the applicator 1150. It can be advantageous to use the coupling mechanism 1100 over coupling the components with adhesive because adhesive dispensing and curing can be variable. In addition, if the ferrules 1130 and the treatment component of the applicator 1150 (e.g.,the treatment component 452 of FIG. 4) are made of the same material, then the two components will have the same coefficient of thermal expansion and will be less susceptible to cracking and / or leaking due to temperature cycling.
[0075] FIGS. 12A and 12B show an applicator 1250 with a flexible circuit 1260 extending through the applicator 1250. FIG. 12A shows a treatment component 1252 of the applicator 1250 with an active face 1257. The active face 1257 can include one or more sensors 1270 used to monitor thermal treatment of the tongue. In some embodiments, the sensors 1270 are temperature sensors that can record temperature measurements at the active face 1257. The applicator 1250 can include any features or functionality of the applicator 350 of FIG. 4 except that the flexible circuit 1260 threads through the applicator 1250 via an opening 1275 between an inlet tube 1225, an outlet tube 1245, and coupling members 1255a and 1255b (collectively referred to as “coupling members 1255”). FIG. 12B shows a base component 1251 of the applicator 1250 including a flexible circuit 1260 and onboard electronics 1280. The onboard electronics 1280 can be a Printed Circuit Board Assembly (PCBA) within the base component 1251 and electrically coupled to the flexible circuit 1260. The base component 1251 can maintain the onboard electronics 1280 using an epoxy and / or a lid (not illustrated). The epoxy and / or lid can further protect the electrical components of the onboard electronics 1280 from strain placed on applicator 1250 during insertion and / or throughout treatment.
[0076] Referring now to FIGS. 12A and 12B together, the flexible circuit 1260 transmits measurements from the sensors on the face of an applicator during thermal treatment (e.g., the sensors 470 on the active face 457 of the applicator 350 of FIG. 4) to the onboard electronics 1280. The onboard electronics 1280 can convert these measurements into corresponding analog voltage or current signals. This allows the measurements from the sensors on the applicator to be processed and interpreted by the onboard electronics 1280 and sent as analog signals to a controller (e.g., the controller 122 of FIGS. 1). Converting measurements locally at the onboard electronics 1280 can reduce potential effects of electromagnetic interference on the analog measurements by integrating sensor and signal conversion functions into the flexible circuit 1260 and the onboard electronics 1280 instead of having these tasks performed elsewhere or remotely. Additionally or alternatively, the controller can change the flow rate of temperature-controlled fluid flowing to the applicator based on the measurements from the sensors and the converted analog signal from the onboard electronics 1280. For example, if a thermistor at the active face of the applicator measures a resistance readingand the converted analog signal corresponds to a surface temperature generally too high to cause adipose cell death by cryolysis at a depth of 1 cm and / or cell death of surface lymphoid tissue (e.g., above a temperature between -30°C to 10°C), the flow rate of temperature-controlled fluid to the applicator increases to maintain a target surface temperature of -30°C to 10°C to achieve a temperature of at least 10°C to 30°C 1 cm deep into the target area. Converting measurements locally can further provide flexibility to add or adjust measurements without changing the interface to the controller, the ability to change the type or characteristics of temperature sensors without changing the interface, and / or the ability to individually calibrate temperature sensors in manufacturing.
[0077] In some embodiments, the flexible circuit 1260 and the onboard electronics 1280 are calibrated and optimized to function in the ranges of temperatures used when administering thermal treatment (e.g., an operating range between -40°C to 37°C or any temperature therebetween). In some embodiments, the flexible circuit 1260 and the onboard electronics 1280 collect, convert, and update the temperature readings at the applicator surface at a frequency between 0.5 Hz and 2.5 Hz (e.g., between 0.5 and 2.5 readings per second) or any frequency therebetween. The user can test the flexible circuit 1260 and the onboard electronics 1280 for accuracy by testing if the components are able to convert a measurement to an analog signal for a temperature between -30°C and 10°C with a + / - 0.5°C accuracy. In some alternate embodiments, the user customizes the flexible circuit 1260 and / or the onboard electronics 1280 to interpret and convert pressure, fluid flow, contact, and / or electrical impedance measurements into analog signals to monitor thermal treatment specific to the patient’ s needs.
[0078] FIG. 13 shows a fabric 1300 shaped for an applicator. In some embodiments, the fabric 1300 includes one or more cuts 1305a-1305e (referred to collectively as “cuts 1305”) that create one or more edges 1307a-1307f (referred to collectively as “edges 1307”) that allow the fabric 1300 to conform and / or complement an active face of the applicator (e.g., the active face 457 of the applicator 350 of FIG. 4). The fabric 1300 can be folded at the cuts 1305 over an applicator, and the edges 1307 created at the cuts 1305 can fit between a treatment component and a base component of the applicator (e.g., the base component 451 and the treatment component 452 of the applicator 350 of FIG. 4) such that the fabric 1300 remains smooth on the active face of the applicator. In some embodiments, the fabric 1300 is made of a material suitable for contacting the tongue and / or oropharyngeal area. Additionally or alternatively, the fabric 1300 can be made of a material with high absorptiveproperties. For example, the fabric 1300 is a polyester fabric (e.g., continuous filament knit polyester). In some embodiments, the fabric 1300 is a foam (e.g., polyurethane foam) and / or another material with high absorption properties. The fabric 1300 can also come pre-soaked in cryoprotectant or the user can manually soak the fabric 1300 in cryoprotectant before applying the fabric 1300 to the applicator and / or to the target area to protect the target area from excess cooling damage.
[0079] FIG. 14 shows an applicator 1450 with the fabric 1300 of FIG. 13. Coupling members 1455a and 1455b (collectively referred to as “coupling members 1455”) can fluidically couple an inlet tube 1425 and an outlet tube 1445 to the applicator 1450, as described in more detail with reference to FIG. 11. The applicator 1450 can include a treatment component 1452 with an active face 1457. The treatment component 1452 and the active face 1457 can include any features or functionality of the treatment component 452 and active face 457 of the applicator 350 of FIG. 4, respectively. In some embodiments, the fabric 1300 covers the active face 1457 of the applicator 1450. Additionally or alternatively, the fabric 1300 can wrap around a back face of the treatment component 1452. In some embodiments, the edges 1307 span over the coupling members 1455 to tuck in between the treatment component and the base component of the applicator 1450, maintain the fabric 1300 on the active face 1457. Additionally or alternatively, the edges 1307 can wrap around the coupling members 1455 to tuck in between the applicator 1450 and a working channel assembly (e.g., the working channel assembly of FIGS. 18A and 18B). It can be advantageous to tuck the edges 1307 between the applicator 1450 and the working channel assembly because the coupling mechanism between the two components, as described in more detail with reference to FIGS. 18A and 18B, is typically mechanical and the user can removably couple and / or uncouple the two components a number of times, simplifying the assembly process relative to alternative methods.
[0080] FIG. 15 shows an insulator 1500. The insulator 1500 can include one or more cuts 1505a-1505d (referred to collectively as “cuts 1505”) that create one or more edges 1507a-1507c (referred to collectively as “edges 1507”). The insulator 1500 can further include legs 1510a and 1510b (referred to collectively as “legs 1510”) and indicators 1515a and 1515b (referred to collectively as “indicators 1515”). In some embodiments, the insulator 1500 is configured to couple one or more sides of an applicator (e.g., the applicators 350 and 550 of FIG. 4 and 5A-5C, respectively). In some embodiments, the indicators 1515 can be visual indicators. For example, the indicators 1515 can be colored (e.g., green and / or blue) to provide contrast with other areas of theinsulator 1500 and / or the oral cavity for the user to visualize the applicator in the oral cavity. Green and blue indicators may be generally more favorable visual indicators because green and blue do not produce glare or blend in with tissue at the target area, whereas red, white, and black indicators are generally less distinct once inside the patient’s mouth. Additionally or alternatively, the indicators 1515 can be configured with one or more shapes and / or can extend or surround various portions of the insulator 1500, as described in more detail with reference to FIGS. 18A-18C.
[0081] FIG. 16 shows an applicator 1650 coupled to the insulator 1500 of FIG. 15. As shown in FIG. 16, the cuts 1505 that create the edges 1507 can allow the insulator 1500 to conform and / or complement a back face 1675 of the applicator 1650 (e.g., the back face 575 of the applicator 550 of FIG. 5A). The legs 1510 can couple sides 1680a and 1680b (referred to collectively as “side 1680”) of the applicator 1650. The back face 1675 can include the indicators 1515. In doing so, the indicators 1515 can assist in proper placement of the applicator 1650 in the oral cavity. In some embodiments, the insulator 1500 provides thermal insulation to the applicator 1650 and reduces unintentional damage to non-target areas throughout thermal treatment. Additionally or alternatively, the insulator 1500 can include additional features, consisting of different materials, thicknesses, and / or air-filled chambers at various sites on the applicator 1650 to provide thermal insulation and protect non-target areas throughout thermal treatment.
[0082] FIG. 17 shows working channels 1760a and 1760b (collectively referred to as “working channels 1760”). The working channels 1760 can include any features or functionality of the working channels 360 of FIG. 3. The working channels 1760 can comprise one or more lumens with distal end portions 1770a and 1770b (collectively referred to as “distal end portions 1770”), can functionally guide passage of one or more working instruments (e.g., endoscopes and / or suction tubes). The distal end portions 1770 can be configured to position the working instruments at an angle a2 when exiting the working channels 1760. For example, the distal end portions 1770 can be angled relative to a longitudinal axis of the working channels 1760 by the angle a2. The longitudinal axis can extend from a top portion of the distal end portions 1770 along a length of the working channels 1760. In some embodiments, the longitudinal axis of the working channel 1760 can be generally parallel to the longitudinal axis of an applicator, e.g., a backside of an applicator 1850, as described in more detail with reference to FIGS. 18A-18C. The angle a2 can be between 10° and 80° or any angle therebetween, or at most 10°, 45°, or 80°. The angle a2 can position the working instruments beyondthe soft palate and before the epiglottis to provide effective visualization of an applicator (e.g., the applicator 350 of FIG. 3) and / or anatomical features at the target area. In some embodiments, the angle a2 positions the working instruments at a distance between 30 mm to 50 mm, or any length therebetween, from the distal end portions 1770, as described in more detail with reference to FIG. 18B. Additionally or alternatively, the working channels 1760 can have a cross-sectional dimension (D5) between 4 mm and 8 mm, or any cross-sectional dimension therebetween to accommodate various types of flexible working instruments used in nasopharyngolaryngoscopy.
[0083] The working channels 1760 can be configured to withstand a compressive of force between 80N and 100N, or any force therebetween, such that the working channels 1760 maintain integrity and / or do not deform throughout the placement of the applicator on the target area. In some embodiments, the working channels 1760 are made of a clear tubing that allows the user to visualize the orientation of the working instruments within the working channels 1760 as the applicator is place on the target area.
[0084] FIGS. 18A-18C show a working channel assembly 1800. As shown in FIG. 18 A, the working channel assembly 1800 can include working channels 1860a and 1860b collectively referred to as “working channels 1860”, an arm 1810, an insulator 1862, and an applicator 1850. The working channels 1860 can include any features or functionality of the working channels 1760 of FIG. 17. The arm 1810 can include any features or functionality of the arm 310 of FIG. 3 and / or the aim 1910 of FIGS. 19A and 19B. The insulator 1862 can include any features or functionality of the insulator 1500 of FIGS. 15 and 16. The applicator 1850 can include any features and functionality of the applicator 350, 550 of FIGS. 3 and 5A-5D, respectively. In some embodiments, the working channel assembly 1800 includes one or more depressions 1867a and 1867b collectively referred to as “depressions 1867”. The depressions 1867 can be configured to mate with the working channels 1860. In some embodiments, the user mounts the working channels 1860 to the depressions 1867 by one or more couplers and / or clamps. For example, the depressions 1867 can clamp the working channels 1860. In yet another example, the working channels 1860 can be coupled to the applicator 1850 using one or more couplers (e.g., pins) that extend through an axis perpendicular to the length of the working channels 1860 to the insulator 1862 and / or to the applicator 1850. For example, the working channels 1860 can be coupled the applicator 1850 at one or more attachment points (e.g., the one or more attachment points 577 of FIG. 5B). The working channels 1860 can move and / or rotate relative to theapplicator 1850 about the axis of the attachment points to aid with positioning the applicator 1850 at the target area. In doing so, this can prevent the user from misaligning the working channels 1860, and thus the working instruments, relative to the applicator 1850 during placement. The insulator 1862 can include an indicator 1875 that extends from a backside portion 1872a of the insulator 1862 to a distal end portion 1872b of the insulator 1862. Additionally or alternatively, the indicator 1875 can extend down a center and / or intermediate portion of the insulator 1862. The indicator 1875 can include any features or functionality of the indicators 1515 and can be configured to assist in visualizing the applicator 1850 at the tongue.
[0085] A coupler 1815 can further couple the arm 1810 to the applicator 1850. The coupler 1815 can create a mechanical (i.e., adhesive-less) attachment between the arm 1810 and the applicator 1850. It is worth noting that although the coupler 1815 does not appear to extend through the depressions 1867, the coupler 1815 or a generally similar' coupler can extend through the depressions 1867 to couple the applicator 1850 to the arm 1810. It can be advantageous to use a mechanical attachment mechanism to couple the components of the working channel assembly 1800 because mechanical attachment mechanisms are generally easier to assemble and less variable than adhesive attachment mechanisms (e.g., heat cure adhesive). Additionally or alternatively, the coupler 1815 can limit the movement of the arm 1810 in one or more planes. For example, the arm 1810 is constrained to move only in the X-Y plane to limit movement of the applicator 1850 during insertion. In doing so, the user can position the applicator 1850 onto the tongue more intuitively, increasing patient safety and reducing the overall procedure time.
[0086] As shown in FIG. 18B, the applicator 1850 coupled to the insulator 1862, the arm 1810, and the working channels 1860 has a height (H8). H8 can be between 15 mm and 25 mm, or any height therebetween that does not reduce visualization and / or maneuverability of the tongue cryoprobe. The working channels 1860 can further include proximal end portions 1865 and distal end portions 1870. The working channel assembly 1800 can include an area extending from the distal ends 1870 of the working channels 1860 to a distal end 1858 of the applicator 1850. The area can have a distance (D6) between 30 mm and 50 mm, or any value therebetween. When the applicator is positioned within the patient, the distance (D6) helps ensure the working channels 1860 are positioned beyond the soft palate and the uvula, improving maneuverability of the tongue cryoprobe to position the applicator onto the tongue. For example, the distance (D6) helps ensure the working channels arepositioned beyond the soft palate but before the epiglottis, while still positioning the applicator 1850 down into the vallecula space. In some embodiments, the indicator 1875 of the insulator 1862 extends along the length of the distance (D6). The angle between the proximal end portions 1865 and the distal end portions 1870 can be an angle a3 can be between 60° and 120°, or any angle therebetween, or at least 60°, 90°, or 120°. In some embodiments, the angle a3 is configured such that the proximal end portions 1865 are generally parallel to the vertical access of the arm 1810 and / or proximal portions of the inlet tube and outlet tube (not illustrated). Additionally or alternatively, the angle a3 can position the proximal ends of the working instruments (not illustrated) exiting the patient’s mouth generally vertically, which advantageously can enable easier access by the user throughout treatment.
[0087] As shown in FIG. 18C, the insulator 1862 can surround the applicator 1850 such that the only exposed surface of the applicator 1850 is an active surface 1857 (e.g., the active surface 457, 557 of FIGS. 4 and 5A, respectively). Additionally or alternatively, the indicator 1875 can extend from the distal end portion 1872b of the insulator 1862 to the front portion 1872c of the insulator 1862. The insulator 1862 can add between 5 mm to 15 mm of width to the width of the applicator 1850, or at most 5 mm, 10 mm, or 15 mm of width to the applicator 1850 such that the insulator 1862 does not decrease maneuverability of the applicator 1850 onto the target area. The widths of the applicator 1850 are described in more detail with reference to FIG. 5A. In some embodiments, the working channel assembly 1800 includes a first working channel (e.g., working channel 1860a) that can receive an optics camera and a second channel working channel (e.g., working channel 1860b) that can receive a suction tube. The optics camera and the suction tube can be working instruments used to assist with visualization before, after, and / or during operation. For example, the optics camera (e.g., an endoscope) can assist in visualization of the cryoprobe and its placement in relation to the epiglottis, soft palate, and / or vallecula, and the suction tube can remove excess saliva, blood, and / or cryoprotectant from the oral cavity. The use of the working channels 1860 in operation with working instruments is described in more detail with reference to FIGS. 23C and 23D.
[0088] FIGS. 19A and 19B show an arm 1910 in various states. The arm 1910 can include any features or functionality of the aim 310 of the tongue cryoprobe 300 of FIG. 3. Referring to FIGS. 19A and 19B together, the arm 1910 can include a body 1918, and elongated portion 1970 extending from the body 1918, and a distal end portion 1950 extending from the elongated portion 1970. The arm 1910 can further include a triggering mechanism 1913 coupled to and movable along a length ofthe body 1918. The triggering mechanism 1913 can include a housing 1930 and a support interface 1917. The housing 1930 can include a switch 1925 (e.g., a rocker switch) and a pin 1940. The user can manually actuate the switch 1925 (e.g., by proximally pulling and / or distally pushing the housing 1930) to release the pin 1940. Additionally or alternatively, the switch 1925 can be behind a wall 1945 in the housing 1930 to prevent inadvertent triggering during the placement of the tongue cry oprobe.
[0089] In some embodiments, the user activates the arm 1910 by distally pushing the housing 1930 from the proximal end of the body 1918 (as shown in FIG. 19 A) to a position along the body 1918 (as shown in FIG. 19B). As shown in FIG. 19A, the triggering mechanism 1913 is in a charged state in which the pin 1940 is released and no tension is applied to (e.g., pulling up on) the distal end portion 1950 of the arm 1910. As shown in FIG. 19B, the triggering mechanism 1913 is in an activated state in which the pin 1940 is locked. In the activated state, tension is applied to the distal end portion 1950 of the arm 1910, creating traction between the applicator (e.g., the applicator 350 of FIG. 3) and the tongue. In some embodiments, the traction maintains the position of the tongue cryoprobe at the tongue. Additionally or alternatively, the support interface 1917 can be attached to a fixation arm (e.g., the fixation arm 112 of FIG. 1) to secure the tongue cryoprobe adjacent to the patient throughout treatment.
[0090] In a similar manner, the user can actuate the switch 1925 once more to interrupt the tension at the distal end portion 1950 once thermal treatment is complete and traction is no longer needed. For example, the user can detach the support interface 1917 from the fixation arm and actuate the switch 1925 by proximally pulling the housing 1930 from along the body 1918 (FIG. 19B) back to the proximal end of the body 1918 (FIG. 19A). In some embodiments, the user terminates traction on the distal end portion 1950 to remove the tongue cryoprobe from the tongue.
[0091] Although only the arm 1910 is shown in FIGS. 19A and 19B, it is worth noting that the triggering mechanism 1913 can be configured to provide traction to the applicator of the tongue cryoprobe such that the tongue cryoprobe maintains its position on the tongue, as described in more detail with reference to FIG. 3.IV. Additional Components for Treatment of OSA
[0092] FIGS. 20A-20D show a conduit system 2000. Referring to FIGS. 20A and 20B together, the conduit system 2000 can include a conduit 2010 (e.g., a corrugated tube) with an inlet fluid channel 2025, an outlet fluid channel 2045, and one or more spacers 2030a- 2030h (collectively referred to as “spacers 2030”) within the conduit 2010. The conduit system 2000 can further include a support hook 2020 coupled to an external surface of the conduit 2010 and coupling members 2050a and 2050b (collectively referred to as “coupling members 2050”) coupled to end portions 2070a and 2070b (collectively referred to as “end portions 2070”) of the conduit 2010. In some embodiments, each of the coupling members 2050 mechanically clamp down onto the end portions 2070. The coupling members 2050 can fluidically couple the inlet fluid channel 2025 and the outlet fluid channel 2045 to a respective inlet tube and an outlet tube of a cryoprobe (e.g., the inlet tube 325 and the outlet tube 345 of the tongue cryoprobe 300 of FIG. 3) and / or a thermal treatment unit (e.g., the thermal treatment unit 106 of FIG. 1). More specifically, the coupling member 2050a can be coupled to the channel end portions 2025a, 2045a of the inlet fluid channel 2025 and the outlet fluid channel 2045, respectively. As such, the channel end portions 2025a, 2045a can fluidically couple the inlet fluid channel 2025 and the outlet fluid channel 2045 to the thermal treatment unit 106. In a similar manner, the coupling member 2050b can couple channel end portions 2025b, 2045b of the inlet fluid channel 2025 and the outlet fluid channel 2045, respectively. The channel end portions 2025b, 2045b can fluidically couple the inlet fluid channel 2025 and the outlet fluid channel 2045 to the inlet tube 325 and the outlet tube 345 of the tongue cryoprobe 300. In some embodiments, the conduit 2010 and the coupling members 2050 are the conduit 118 and the coupling members 120 of the system 100 of FIG. 1. In some embodiments, the support hook 2020 couples the conduit 2010 to a positioning arm (e.g., the fixation arm 112 of FIG. 1). The support hook 2020 can position the conduit system 2000 in a preferred location between the positioning aim, the cryoprobc, and / or the patient.
[0093] FIG. 20C shows a view of the end portion 2070a of the conduit system 2000. As shown in FIG. 20C, the spacers 2030 can be generally shorter in length (e.g., between 2 cm and 10 cm, or any length therebetween) and placed at lineal’ intervals (e.g., between 5 cm and 25 cm apart, or any interval therebetween), allowing the user to bend the conduit 2010 while maintaining the inlet fluid channel 2025 and the outlet fluid channel 2045 at an intermediate portion (e.g., center) of the conduit 2010. In some embodiments, the user selects the spacing interval between the spacers 2030 tomaintain flexibility and maximize thermal insulation of the conduit system 2000. For example, the shorter the interval between the spacers 2030, the less flexible the conduit system 2000 is, and the larger the interval between the spacers 2030, the more likely the inlet fluid channel 2025 and / or the outlet fluid channel 2045 contacts the conduit 2010 and / or kinks when the conduit 2010 is bent. In some embodiments, if there is a larger interval between the spacers 2030, the air mass between the conduit 2010 and the inlet fluid channel 2025 and / or the outlet fluid channel 2045 can be decreased and / or eliminated, which in turn can decrease the insulative effect of the air gap between the conduit 2010 and the inlet fluid channel 2025 and / or the outlet fluid channel 2045, as described in more detail with reference to FIG. 20D. Air insulation is maximized when convective heat transfer is minimized. Convective heat transfer can also be a function of the amount of relative movement between media, which in the conduit system 2000, can include the conduit 2010, the inlet fluid channel 2025, the outlet fluid channel 2045, and the air. The user can place the coupling members 2050 at either end of the conduit 2010 to minimize air movement of the conduit system 2000. In some embodiments, the inlet fluid channel 2025 and the outlet fluid channel 2045 exit at the center of the distal portion of the coupling members 2050 and maintain a minimal gap between the fluid channels, as described in more detail with reference to FIG. 20D. Additionally or alternatively, the coupling members 2050 can be coupled to the inlet fluid channel 2025, the outlet fluid channel 2045, and a relief component, as described in more detail with reference to FIGS. 21A-21D.
[0094] FIG. 20D shows a top view of the conduit system 2000 looking directly down the conduit 2010. The inlet fluid channel 2025 and the outlet fluid channel 2045 run within and down the center of the conduit 2010 through a lumen 2035a in the spacer 2030a. Although not explicitly shown in FIGS. 20A-20D, a lumen generally similar to the lumen 2035a can be on the spacers 2030b-2030h. The lumen 2035a can be configured to keep the inlet fluid channel 2025 and the outlet fluid channel 2045 held at the intermediate portion of the conduit 2010 with minimal space therebetween. Positioning the inlet fluid channel 2025 and the outlet fluid channel 2045 at the intermediate portion of the conduit 2010 advantageously maximizes the amount of air between the inner surface of the conduit 2010 and the outer surface of the inlet fluid channel 2025 and the outlet fluid channel 2045. Assuming there is no convective heat transfer (i.e., minimal air movement), air can be an excellent thermal insulator. Therefore, maximizing the air space between the inlet fluid channel 2025 and the outlet fluid channel 2045 and the conduit 2010 can maximize the thermal insulation of the conduitsystem 2000. In addition, the conduit system 2000 can be advantageous to other potential insulating tubing constructions (e.g., a thicker silicone tube or open cell foam tube) because the conduit 2010 can be generally more flexible and lightweight, proving the user more control positioning the conduit 2010 throughout the surgical procedure.
[0095] In some embodiments, the conduit 2010 is a corrugated tube. Off-the-shelf corrugated tubes are used frequently in various machines and products, including vacuum cleaners and medical devices, and thus, are not difficult to locate for manufacturing. In addition, off-the-shelf corrugated tubes can be more readily manufactured to include custom integration components (e.g., the coupling members 2050 and the spacers 2030).
[0096] In some embodiments, the conduit 2010 is made of a polymer and the spacers 2030 are made of a metal. One potential drawback of having metal spacers integrated into the walls of the conduit 2010 can be that bending the conduit 2010 can cause a rotation at the end portions 2070. Since the end portions 2070 can be coupled to the coupling members 2050 and the coupling members 2050 can be tightly fit to the inlet fluid channel 2025 and the outlet fluid channel 2045, the moment from the rotation of the conduit 2010 can transfer to the inlet fluid channel 2025 and the outlet fluid channel 2045. As such, if the inlet fluid channel 2025 and the outlet fluid channel 2045 are coupled to a tongue cry oprobe, bending the conduit 2010 can cause a rotational moment to be transferred down the entirety of the tongue cryoprobe. For example, the rotational moment can cause a tongue cryoprobe positioned in a patient’s mouth to lose contact with the target area and thus lead to cold injury on non-target areas and / or longer procedure times.
[0097] In some embodiments, the rotation problem described above is overcome by integrating a rotational element into the coupling members 2050. FIGS. 21A-21D shows a coupling member 2150 with a relief component 2155. In some embodiments, the coupling member 2150 is one of the coupling members 2050 of the conduit system 2000 of FIGS. 20A-20D. FIG. 21 A shows an isometric view of the coupling member 2150 coupled to a conduit 2110. The conduit 2110 can include any features or functionality of the conduit 2010 of FIGS. 20A-20D. The coupling member 2150 can include a cover component 2151, a base component 2152 coupled to the base component 2152, and a relief component 2155. In some embodiments, the cover component 2151 couples the base component 2152 such that the relief component 2155 can remain within the coupling member 2150. Stated differently, at least one of the cover component 2151 or the base component 2152 is rotatablerelative to the relief component 2155, such that rotation of the cover component 2151 or base component 2152 is not translated to the relief component 2155. The cover component 2151 can be coupled to the base component 2152 using one or more coupling mechanisms including joints, screws, adhesive, and / or the like. The coupling member 2150 can further include an inlet channel 2125 and an outlet channel 2145. The inlet channel 2125 and the outlet channel 2145 can include any features or functionality of the inlet fluid channel 2025 and the outlet fluid channel 2045 of FIGS. 20A-20D.
[0098] FIG. 21B shows a cross sectional view of the coupling member 2150 of FIG. 21A. In some embodiments, the coupling member 2150 is configured to maintain an end portion 2170 of the conduit 2110. For example, the base component 2152 includes one or more protrusions 2190a-2190c (collectively referred to as “protrusions 2190”) that maintain the end portion 2170 of the conduit 2110 within the coupling member 2150. The protrusions 2190 can be configured to mate with one or more ridges 2195a and 2195b (collectively referred to as “ridges 2195”) of the conduit 2110. The cover component (e.g., the cover component 2151 of FIG. 21 A) can include identical or generally similar protrusions to the protrusions 2190 included on the base component 2152. A rotational mate 2160 can be coupled to the relief component 2155 and to the coupling member 1350. The rotational mate 2160 and the relief component 2155 can include one or more openings configured to hold and / or secure the inlet channel 2125 and the outlet channel 2145 as the channels exit the coupling member 2150. The rotational mate 2160 can constrain the relief component 2155 along the XYZ axis such that the relief component 2155 can only rotate relative to coupling member halves (e.g., the cover component 2151 and / or the base component 2152) and not in a direction along the axis of the conduit 2110. Stated differently, the relief component 2155 can limit rotation within the coupling member 2150. Thereby, allowing the conduit 2110 to be twisted and / or bent without transferring the twist and / or bend to the inlet fluid channel 2125 and the outlet channel 2145, as described in more detail with reference to FIGS. 21C and 21D.
[0099] In some embodiments, the relief component 2155 and the coupling member 2150 are constructed of lubricious materials (e.g., acetal or polyoxymethylene (POM), polytetrafluoroethylene (PTFE), and / or the like). In some embodiments, the rotational mate 2160 couples the relief component 2155 to the coupling member 2150 such that there is no interference that would create bending between the two components. Additionally or alternatively, the user can apply a lubricant (e.g., lithium grease) to the interface between the relief component 2155 and the coupling member 2150 toprevent interference. However, it can be advantageous to use the rotational mate 2160 over a lubricant in the interface since lubricant application can have more inherit variability.
[0100] FIGS. 21C and 21D show the coupling member 2150 of FIG. 21A in various states. FIG. 21C shows the coupling member 2150 rotating in a counterclockwise rotation 2180. FIG. 21D shows the coupling member 2150 once that rotation has been complete. As shown in FIGS. 21C and 21D, the relief component 2155 can maintain the inlet channel 2125 and the outlet channel 2145 in relatively the same position before and after the counterclockwise rotation 2180. The relief component 2155 can be rotationally coupled to the coupling member 2150 such that the relief component 2155 can rotate relative to the coupling member 2150 freely. Thus, for some embodiments of the present technology, if the conduit 2110 or the coupling member 2150 is rotated, the rotation is not transferred to the relief component 2155 or the inlet channel 2125 and the outlet channel 2145. Furthermore, for such embodiments, if the rotation is not transferred to the inlet channel 2125 and the outlet channel 2145, imparting the rotational moment to the cryoprobe (e.g., the tongue cryoprobe 300 of FIG. 3) can be reduced and / or eliminated.
[0101] FIG. 22 shows a kit 2200 for a sleep apnea treatment system. The kit 2200 can include a cryoprotectant agent 2220, a tongue cryoprobe 2230 (e.g., the tongue cryoprobe of FIG. 3), a soft palate cryoprobe 2240, a conduit system 2250 (e.g., the conduit system 2000 of FIGS. 20A-20D), and an insulator 2260. The kit 2200 can come in a container 2270. In some embodiments, a container filler 2280 is on top of the components in the kit 2200 to protect the components during shipment. The container filler 2280 can be configured to fill the void between the components of the kit 2200 and the top of the container 2270. The container filler 2280 can be a foam insert, foam peanuts, and / or the like. In some embodiments, additional containers 2285a-2285e (referred to collectively as “additional containers 2285”) house and / or store the cryoprotectant agent 2220, the tongue cryoprobe 2230, the soft palate cryoprobc 2240, the conduit system 2250, and the insulator 2260. The additional containers 2285 can be configured to fit within the container 2270. Moreover, the additional containers 2285 can isolate the subcomponents of the cryoprotectant agent 2220, the tongue cryoprobe 2230, the soft palate cryoprobe 2240, the conduit system 2250, and the insulator 2260, respectively. The container 2270 and the additional containers 2285 can be reusable or disposable boxes.
[0102] In some embodiments, the cryoprotectant agent 2220 comes pre-made and sealed in a cup and / or pouch (not illustrated). In operation, a physician can open the cup and / or pouch and place the cryoprotectant agent 2220 on an applicator of a cryoprobe and / or directly on the target area. In some embodiments, the kit 2200 further includes a spatula- like device (not illustrated) used to apply the cryoprotectant agent 2220. The cryoprotectant agent 2220 can be a liquid cryoprotectant agent (e.g., glycerol) or a cryoprotectant agent constructed in gel (e.g., a glycerol-gel). Liquid cryoprotectant agents are generally less viscous than cryoprotectants constructed in gel, and thus, are generally more variable in application. For example, cryoprotectant agents that are constructed in a gel remain generally constant in volume when applied to the target area, making application more consistent.
[0103] The cryoprotectant agent 2220 can be designed with various properties in mind. For example, the cryoprotectant agent 2220 can be glycerol-gel made of a hydrogel or anhydrous, as well as cross-linked or not cross-linked. Cross-linked gels can be chemically cross-linked or physically crosslinked, for example, by ionic crosslinking. In some embodiments, the cryoprotectant agent 2220 is a biodegradable hydrogel scaffold. For example, the cryoprotectant agent 2220 includes silicon casing scaffold components made of alginate and / or gelatin. In some embodiments, the gelatin is cross-linked in various combinations ratios for different degradation rates. This can ensure that the cryoprotectant agent 2220 does not dissolve before thermal treatment is complete. Scaffolding components can be natural and biodegradable, synthetic and biodegradable, or synthetic and non- biodcgradablc. For example, natural and biodegradable scaffolding of a glyccrol-gcl contains alginate, hyaluronic acid, gelatin, chitin / chitosan, dextran, amylose, lignin, gum (guar, xanthan, etc.), etc. Additionally or alternatively, the glycerol-gel can be synthetic and / or a biodegradable chemical compound including, poly(lactic acid) (PLA), poly(glycolide acid) (PGA), poly(lactic-co-glycolic acid) (PLGA), polycaprolactone (PCL), polyhydroxybutyrate (PHB), polybutylonesuccinte (PBS), poly(vinyl alcohol) (PVOH, PVA, or PVA1), polyaminoacids, etc. In some embodiments, if the glycerin-gel is synthetic and non-biodegradable, chemical compounds can include poly(N- isopropylacrylamide), polyurethane, cellulose derivatives such as carboxymethylcellolose, and / or carbapol. Depending on the polymers utilized, the glycerol-gel can have additional environmentally responsive features, such as temperature sensitivity, mucoadhesive qualities, etc. For example, theglycerol-gel includes a mucoadhesive polymer such as carboxymethylcellulose that can adhere to the surface of a target area.
[0104] The soft palate cryoprobe 2240 can include one or more components configured to thermally treat a soft palate. The soft palate cryoprobc 2240 can include a housing and an applicator coupled to and at a distal end portion of the housing. The soft palate cry oprobe 2240 can further include an inlet tube and an outlet tube, and a length of the inlet tube and outlet tube can be held within the housing. The applicator of the soft palate cryoprobe 2240 can be angled relative to an axis parallel to the length of the housing. In some embodiments, the angle is equivalent to the position of the soft palate relative to the housing when the soft palate cryoprobe 2240 is inserted into a patient’s mouth. Thus, when the soft palate cryoprobe 2240 is inserted into the patient’s mouth, the applicator can make direct contact with the soft palate without needing to adjust the position of the housing and / or the applicator, reducing the length of the surgical procedure. In some embodiments, the inlet and outlet tubes are positioned to direct chilled and / or heated fluid to and from a surface of the applicator. The surface of the applicator can be an active surface that is minimally invasive and thermally treats the soft palate. The conduit system 2250 can fluidically couple the soft palate cryoprobe 2240 to a chilled and / or heated fluid source (e.g., the thermal treatment unit 106 of FIG. 1). The applicator can further include a flexible circuit electrically coupled to one or more temperature sensors on an active face of the applicator to monitor the thermal treatment of the soft palate. In some embodiments, onboard electronics are integrated into the soft palate cryoprobe. For example, the onboard electronics arc integrated into the handle of the cryoprobc. The onboard electronics can process and convert measurements from the one or more temperature sensors, as described in more detail with reference to the onboard electronics of FIGS. 12A and 12B.
[0105] In some embodiments, the insulator 2260 is used with the soft palate cry oprobe 2240 to protect non-target areas during thermal treatment of the soft palate. The insulator 2260 can include an insulating pad, an elongated body, and a contact indicator. The insulator 2260 can provide an insulating layer between the soft palate cryoprobe 2240 and the posterior pharyngeal wall during thermal treatment. More specifically, the user can insert the insulating pad behind the soft palate before administering thermal treatment. The elongated body can couple the insulating pad to the contact indicator. In some embodiments, a distal end of the elongated body includes a uvula cutout. The uvula cutout can allow the elongated body to “fork” at the interface between the elongated bodyand the insulating pad. In some embodiments, the uvula cutout enhances placement of the insulator 2260 on the back side of the soft palate by allowing the user to bypass the uvula. The contact indicator can include a pull tab that the user can pull to provide electrical current to the insulator 2260. The insulating pad can include a tactile switch electrically coupled to the contact indicator by a flexible circuit that extends along an entirety of the length of the elongated body of the insulator 2260. In some embodiments, the flexible circuit can be housed within the elongated body such that wiring from the contact indicator can extend to the tactile switch. The flexible circuit can deliver feedback from the tactile switch to the contact indicator, allowing the user to monitor contact at the soft palate. For example, the contact indicator resides outside the oral cavity and indicates via an LED when the soft palate has been displaced by pressure exerted by the soft palate cryoprobe on the anterior side of the soft palate such that the tactile switch, which is in contact with the posterior side of the soft palate, is engaged. Thus, the contact indicator can indicate to the user that a pressure above a predetermined threshold has been applied by the soft palate cryoprobe to the soft palate, indicating the soft palate cryoprobe is in full contact with the soft palate.
[0106] In some embodiments, the kit 2200 includes one or more additional components from the components discussed herein. Additionally or alternatively, the kit 2200 can be used with the system 100 of FIG. 1. One or more of the components of the kit 2200 can be disposable and can be made of biocompatible and / or sterilizable material. As used herein, the term “disposable” when applied to a system or component (or combination of components), such as the cryoprotectant agent 2220, the tongue cryoprobc 2230, and the soft palate cryoprobc 2240, the conduit system 2250, and / or the insulator 2260, is a broad term and generally means, without limitation, that the system or component in question is used a finite number of times and is then discarded. Some disposable components are used only once and are then discarded. In other embodiments, the components are non-disposable and the user can use them another number of times. In some embodiments, all of the components of the kit 2200 are disposable to prevent cross-contamination.V. Procedural Techniques for Treatment of OSA
[0107] FIGS. 23A-23D show a method and / or procedural stages for thermally treating the oropharyngeal area using a sleep apnea treatment system (e.g., the sleep apnea treatment system 100 of FIG. 1). FIG. 23A illustrates a first method or stage of theimal treatment where the user can insertan insulator 2305 into the oral cavity to contact a posterior side of a soft palate (SP). The insulator 2305 can include any features or functionality of the insulator 2260 of FIG. 22. As shown in FIG. 23A, the insulator 2305 can include an insulating pad 2310 and a contact indicator 2315. The insulating pad 2310 and the contact indicator 2315 can include any features or functionality of the insulating pad and the contact indicator described in more detail with reference to FIG. 22.
[0108] The user can prepare the patient (P) for thermal treatment by placing a bite block (not illustrated) within the patient’s mouth. The bite block can ensure adequate opening and stabilization of the jaw. Additionally or alternatively, the user can place a teeth guard (not illustrated) over the lower teeth to provide protection to an underside of the tongue. The user can then insert the insulator 2305 into the oral cavity to provide protection to a posterior pharyngeal wall (PW) throughout thermal treatment. More specifically, the user can insert the insulator 2305 into the oral cavity such that the insulating pad 2310 contacts the posterior side of the soft palate. The contact indicator 2315 can indicate contact on the soft palate. For example, the LED of the contact indicator 2315 alerts the user if a threshold pressure is applied to the soft palate by a cryoprobe (e.g., the soft palate cryoprobe 2320 of FIG. 23B). The contact indicator 2315 can rest on the patient’s chest (not illustrated) throughout treatment, which can allow the physician to visualize alerts coming from the contact indicator 2315 as thermal treatment is administered to the soft palate. For example, the contact indicator 2315 can indicate the position of a soft palate cryoprobe on the soft palate (SP). The user can use this information to ensure the applicator makes sufficient contact with the soft palate such that the soft palate cryoprobc can cool the soft palate to a predetermined depth.
[0109] FIG. 23B illustrates a second method or stage of thermal treatment where the user can insert a soft palate cryoprobe 2320 into the oral cavity to thermally treat the soft palate (SP). The soft palate cryoprobe 2320 can include any of the details or functionality of the soft palate cryoprobe 2240 of FIG. 22 or other cryoprobes described herein. The soft palate cryoprobe 2320 can include an applicator 2330 configured to thermally treat the soft palate (SP), and a support interface 2328. The applicator 2330 can be. The support interface 2328 can be coupled to the soft palate cryoprobe 2320 and a fixation arm 2350, which can maintain the position of the soft palate cryoprobe 2320 throughout treatment. A coupling member 2355 can be fluidically coupled to the soft palate cryoprobe 2320 and a conduit 2360. The conduit 2360 can be fluidically coupled to a thermal treatment unit (e.g., the thermal treatment unit 106 of FIG. 1) and the soft palate cryoprobe 2320 such that the thermaltreatment unit can administer chilled / heated fluid to the soft palate cryoprobe 2320 to thermally treat the soft palate (SP). Additionally or alternatively, the soft palate cryoprobe 2320 can be electrically coupled to a controller (e.g., the controller 122 of FIG. 1) by an electrical cable 2325. The controller can operate the treatment system, as described in more detail with reference to FIG. 1, including regulating the flow of the temperature-controlled fluid to and from the soft palate cryoprobe 2320.
[0110] In some embodiments, the user applies a cryoprotectant agent to the applicator 2330, the soft palate, and / or to the surrounding tissue at the target area before they insert the soft palate cryoprobe 2320 into the oral cavity. Additionally or alternatively, a tongue retractor (not illustrated) can hold the tongue out of the way while the user inserts the soft palate cryoprobe 2320 into the oral cavity. The tongue retractor can allow the user to better visualize and access the soft palate, and therein increase the likelihood of correct placement of the soft palate cryoprobe 2320. In some embodiments, the user inserts the soft palate cryoprobe 2320 into the oral cavity before the support interface 2328 is attached to the fixation arm 2350. More specifically, the user can insert the soft palate cryoprobe 2320 into the oral cavity and position and / or reposition the soft palate cryoprobe 2320 until the applicator 2330 makes sufficient contact with the soft palate (SP). Once the applicator 2330 is in contact with the soft palate (SP), the user can attach the soft palate cryoprobe 2320 to the fixation arm 2350. The fixation arm 2350 can maintain the position of the soft palate cryoprobe 2320, and thereby the applicator 2330 throughout thermal treatment. Additionally or alternatively, the user can attach the support interface 2328 of the soft palate cryoprobe 2320 to the fixation arm 2350 before inserting the soft palate cryoprobc 2320 into the oral cavity.
[0111] Once the soft palate cryoprobe 2320 is secured in place, the sleep apnea treatment system can circulate temperature-controlled fluid through the soft palate cryoprobe 2320 to the applicator 2330, cooling the soft palate (SP) for a predetermined time and temperature. For example, the temperature-controlled fluid circulates through the soft palate cryoprobc 2320 for approximately 30 minutes to bring and / or keep the applicator 2330 at a predetermined temperature (e.g., between - 30°C and 10°C). One or more sensors on the applicator 2330 can monitor the temperature at the soft palate (SP) to determine or approximate the depth of cooling at the target area, as described in more detail with reference to FIG. 22 and other sensors herein. After the duration of thermal treatment has ended, the sleep apnea treatment system can circulate heated fluid through the soft palate cryoprobe 2320, rewarming the soft palate (SP) for a predetermined time and to a predeteimined temperature toreduce damage associated with excess cooling on the SP and shorten patient recovery time, as described in more detail with reference to FIG. 2. After the rewarming phase has ended, the user can uncouple the soft palate cryoprobe 2320 from the fixation arm 2350 and can remove the soft palate cryoprobe 2320 from the oral cavity. In addition, the user can remove the insulator 2305 from the oral cavity, completing thermal treatment of the soft palate.
[0112] FIG. 23C illustrates a third method or stage of thermal treatment including thermal treatment of a tongue (e.g., the BoT, lingual tonsils, etc.) using a tongue cryoprobe 2370. The tongue cryoprobe 2370 can include any features or functionality of the tongue cryoprobe 300 of FIG. 3. The tongue cry oprobe 2370 can include an applicator 2380, a support interface 2378, and working channels 2390. The applicator 2380 can include any features or functionality of the applicator 350 and 550, as described in more detail with reference to FIGS. 3 and 5A-5C, respectively. The working channels 2390 can include any features or functionality of the working channels 1760 and 1860, as described in more detail with reference to FIGS. 17 and 18A-18B, respectively. The applicator 2380 can be configured to thermally treat the tongue. The support interface 2378 can be coupled the tongue cryoprobe 2370 and the fixation aim 2350 to maintain the position of the tongue cryoprobe 2370 throughout treatment. Similar to the operation of the soft palate cryoprobe 2320 described in more detail with reference to FIG. 23B, the coupling member 2355 can be fluidically coupled to the tongue cryoprobe 2370 and the conduit 2360, and the conduit 2360 can be fluidically coupled to the thermal treatment unit such that the conduit 2360 delivers the temperature-controlled fluid to the tongue cryoprobc 2370 to thermally treat the tongue. In a similar manner to the electrical cable 2325 of FIG. 23B, an electrical cable 2375 can be electrically coupled to the tongue cry oprobe 2370 and the controller to regulate the flow of temperature-controlled fluid to and from the tongue cryoprobe 2370 based on the conditions at the tongue.
[0113] In some embodiments, the user applies a cryoprotectant agent to the applicator 2380 or directly to the BoT, the epiglottis, and / or the vallecula before thermal treatment. The user can then insert the tongue cryoprobe 2370 into the oral cavity. More specifically, the physician can insert the tongue cryoprobe 2370 into the oral cavity and position and / or reposition the tongue cryoprobe 2370 until the applicator 2380 makes sufficient contact with the tongue. Once the applicator 2380 is in contact with the tongue, the user can attach the support interface 2378 to the fixation aim 2350 to maintain the position of the tongue cryoprobe 2370, and thereby the applicator 2380, throughoutthermal treatment. In some embodiments, this method is advantageous since the user has more control positioning the applicator 2380 onto the tongue when the tongue cryoprobe is not attached to the support interface 2378. Additionally or alternatively, the user can attach the support interface 2378 to the fixation arm 2350 before inserting the tongue cryoprobe 2370 into the oral cavity. It can be advantageous to attach a cryoprobe to the fixation arm 2350 prior to inserting the cryoprobe into the oral cavity to align the cryoprobe with a preferred trajectory for thermal treatment.
[0114] FIG. 23D, shows a fourth method or stage of thermally treating the oropharyngeal area. As shown in FIG 23D, the user can insert one or more working instruments 2395 through the working channels 2390. The working channels 2390 can guide the working instruments 2395 to the area around the tongue. The working instruments 2395 can include suction tubes and / or endoscopes that aid in positioning the applicator 2380 onto the tongue. In some embodiments, the working instruments 2395 are used to monitor the tongue throughout thermal treatment.
[0115] After the tongue cryoprobe 2370 is positioned on the tongue, the conduit 2360 can deliver temperature-controlled fluid to the tongue cryoprobe 2370. The temperature-controlled fluid can circulate in the applicator 2380, extracting heat and cooling the tongue. In some embodiments, the temperature-controlled fluid circulates through the applicator 2380 for a predetermined time, e.g., between 20 to 80 minutes or any time therebetween, or at least 20 minutes, 40 minutes, 60 minutes, or 80 minutes. This brings the surface temperature of the tongue to a predetermined temperature, e.g., between -30°C to 10°C or any temperature therebetween, or less than 5°C, -10°C, or -27°C. The applicator 2380 can include one or more sensors that can monitor the temperature at the tongue, as described in more detail with reference to FIGS. 4, 12A, and 12B. After cooling treatment ends, the sleep apnea treatment system can circulate heated fluid through the tongue cryoprobe 2370, rewarming the tongue for a predetermined time to a predetermined temperature. For example, the heated fluid circulates in the applicator 2380 for a predetermined time, e.g., between 1 to 20 minutes or any length of time therebetween, or at least 5 minutes, 10 minutes, or 20 minutes. This brings the temperature of the tongue to between 30°C and 40°C or any temperature therebetween and reduces damage associated with excess cooling on the tongue. After the rewarming phase has ended, the working instruments 2395 can be removed from the oral cavity. In addition, the tongue cryoprobe 2370 can be uncoupled from the fixation arm 2350 and removed from the oral cavity, completing thermal treatment of the tongue. It is worth noting that while methods or stages for thermally treatingthe oropharyngeal area are presented in a given order, alternative embodiments can omit individual methods / stages and / or perform one or more of these stages, phases, and / or steps in a different order.
[0116] FIGS. 24-27 show various visualization aids used to guide placement of cry oprobes prior to and during thermal treatment. As described in FIGS. 23A-23D, the applicators of the soft palate cryoprobe and / or the tongue cryoprobe are generally positioned at the at the soft palate or the most superior and posterior section of the tongue, respectively. Since these region falls in the back of the oral cavity, it can be difficult to verify that the applicator has been placed appropriately on the target area. As such, one or more visualization aids, as described in FIGS. 24-27, can be used with the thermal treatment system (e.g., sleep apnea treatment system 100 of FIG. 1) to create, execute, and / or adjust a surgical plan according to the patient’s anatomy.
[0117] FIG. 24 illustrates a fluoroscopy-based visualization aid 2400, which can include a ring 2402 (e.g., a radiopaque ring) over a trachea tube 2404. The trachea tube 2404 can be inserted into the oral cavity such that the ring 2402 is positioned near an epiglottis (EP). Following the positioning of the fluoroscopy-based visualization aid 2400, a cryoprobe (e.g., the soft palate cryoprobe 2320 and / or the tongue cry oprobe 2370 of FIGS. 23A-23D) can be inserted into the mouth under the fluoroscopy guidance. In some embodiments, the fluoroscopy-based visualization aid 2400 is inserted into a working channel (e.g., the working channel 2390 of the tongue cryoprobe 2370 of FIG. 23D) after the cryoprobe is in the oral cavity to help guide the applicator onto the target area and / or to monitor the oral cavity throughout thermal treatment.
[0118] FIG. 25 illustrates a fluoroscopy-based visualization aid 2500, which can include a radio opaque frame 2502, such as a steel wire. The radio opaque frame 2502 can be pre-bent and placed over a tongue (T) of the patient. In operation, the radio opaque frame 2502 can be positioned at the back of the oral cavity, assuring that the distal end of the radio opaque frame 2502 is at the vallecula (V). Following the positioning of the fluoroscopy-based visualization aid 2500, a cryoprobe (e.g., the soft palate cryoprobe 2320 and / or the tongue cryoprobe 2370 of FIGS. 23A-23D) can be inserted into the mouth under the fluoroscopy guidance.
[0119] FIG. 26 illustrates an optical visualization aid 2600, which can be an endoscope that the user advances cither through the nasal passageway (NP) (as shown in FIG. 26) and / or through the oral cavity (OC). The optical visualization aid 2600 can guide the positioning of an applicator 2606onto a tongue (T). In some embodiments, the optical visualization aid 2600 is a fiber optic wand that illuminates the applicator 2606 as the applicator is positioned on the tongue (T). In some embodiments, illuminating the applicator 2606 allows it to be recognized even when submerged under a pool of saliva and / or cryoprotectant fluid. In some embodiments, following the positioning of the optical visualization aid 2600, a cryoprobe (e.g., the soft palate cryoprobe 2320 and / or the tongue cryoprobe 2370 of FIGS. 23A-23D) is placed in the mouth under the visualization guidance. In some embodiments, the optical visualization aid 2600 is inserted into a working channel (e.g., the working channel 2390 of the tongue cryoprobe 2370 of FIG. 23D) after the cryoprobe is in the oral cavity (OC) to guide the applicator of the cryoprobe onto the target area and / or to monitor the oral cavity (OC) throughout thermal treatment. It is worth noting that although the optical visualization aid 2600, as shown in FIG. 26, is positioned to visualize the applicator 2606 on the tongue (T), the optical visualization aid 2600 can be used to position an applicator on the soft palate.[01201 FIG. 27 illustrates an ultrasound-based visualization aid 2700. The ultrasound-based visualization aid 2700 can include an ultrasound transducer placed underneath the chin, just before the crevice of the neck. The ultrasound-based visualization aid 2700 can help visualize the tongue (T) on a display (e.g., a display of the ultrasound machine not shown). In some embodiments, the ultrasound-based visualization aid 2700 is used to monitor the placement of the applicator 2706 on the target area and / or monitor an ice formation 2704 on the tongue (T) throughout thermal treatment. In some embodiments, the ultrasound-based visualization aid 2700 measures the thickness of the ice formation 2704. The distance from the ultrasound-based visualization aid 2700 to the applicator 2706, and the distance from the ultrasound-based visualization aid 2700 to the ice formation 2704 can be obtained / calculated, and used to obtain the ice thickness, which is a difference between the distance from ultrasound cryoprobe to applicator less the distance from ultrasound cryoprobe to ice formation. Monitoring the ice formation 2704 and / or obtaining ice thickness throughout thermal treatment can advantageously prevent excess cooling on the target area and / or non-target areas, as described in more detail with reference to FIG. 1. It is worth noting that although the ultrasound-based visualization aid 2700 as shown in FIG. 27 is positioned to visualize the applicator 2706 on the tongue (T), the ultrasound-based visualization aid 2700 can be positioned to visualize an applicator on the soft palate.
[0121] In some embodiments, the visualization aids described herein are used before the procedure. MRI imaging, ultrasound imaging, and / or electrical impedance tomography can provideuseful information about the patient’s anatomy, which can help plan applicator placement prior to the procedure. One or more imaging devices can also determine if a patient is suitable for treatment using adipose cryolysis. A bioimpedance sensor and / or an ultrasound device can be used to calculate a patient’s fat percentage at the soft palate and the base of tongue to determine if thermal treatment is suitable for the patient’s condition. Other forms of imaging can also be used to determine if a patient is suitable for treatment and / or if additional instruments are necessary for the procedure.VI. Conclusion
[0122] It will be apparent to those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the present technology. In some cases, well known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present technology. Although steps of methods may be presented herein in a particular order, alternative embodiments may perform the steps in a different order. Similarly, certain aspects of the present technology disclosed in the context of particular' embodiments can be combined or eliminated in other embodiments. Furthermore, while advantages associated with certain embodiments of the present technology may have been disclosed in the context of those embodiments, other embodiments can also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages or other advantages disclosed herein to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein, and the invention is not limited except as by the appended claims.
[0123] Where context permits, singular or plural terms may also include the plural or singular term, respectively. In addition, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Furthermore, as used herein, the phrase “and / or” as in “A and / or B” refers to A alone, B alone, and both A and B. Additionally, the terms “comprising,” “including,” “having,” and “with” are used throughout to mean including at least the recited feature(s) such that any greater number of the same features and / or additional types of other features are not precluded. Moreover, as used herein, the phrases “based on,” “depends on,” “as a result of,” and “inresponse to” shall not be construed as a reference to a closed set of conditions. For example, an exemplary step that is described as “based on condition A” may be based on both condition A and condition B without departing from the scope of the present disclosure. In other words, as used herein, the phrase “based on” shall be construed in the same manner as the phrase “based at least in part on” or the phrase “based at least partially on.”
[0124] Throughout this disclosure, the singular terms “a,” “an,” and “the” include plural referents unless the context clearly indicates otherwise. Additionally, the term “comprising,” “including,” and “having” should be interpreted to mean including at least the recited feature(s) such that any greater number of the same feature and / or additional types of other features are not precluded.
[0125] Reference herein to “one embodiment,” “an embodiment,” “some embodiments” or similar formulations means that a particular feature, structure, operation, or characteristic described in connection with the embodiment can be included in at least one embodiment of the present technology. Thus, the appearances of such phrases or formulations herein are not necessarily all referring to the same embodiment. Furthermore, various particular features, structures, operations, or characteristics may be combined in any suitable manner in one or more embodiments.
[0126] Unless otherwise indicated, all numbers expressing concentrations, shear strength, and other numerical values used in the specification and claims, are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims arc approximations that may vary depending upon the desired properties sought to be obtained by the present technology. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Additionally, all ranges disclosed herein are to be understood to encompass any and all subranges subsumed therein. For example, a range of “1 to 10” includes any and all subranges between (and including) the minimum value of 1 and the maximum value of 10, i.e., any and all subranges having a minimum value of equal to or greater than 1 and a maximum value of equal to or less than 10, e.g., 5.5 to 10.
[0127] The disclosure set forth above is not to be interpreted as reflecting an intention that any claim requires more features than those expressly recited in that claim. Rather, as the following claimsreflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment. Thus, the claims following this Detailed Description are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims.
[0128] The present technology is illustrated, for example, according to various aspects described below as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the present technology. It is noted that any of the dependent clauses may be combined in any combination, and placed into a respective independent clause. The other clauses can be presented in a similar manner.1. A tongue cryoprobe, comprising: an inlet tube including a proximal portion and a distal portion; an outlet tube including a proximal portion and a distal portion, wherein the distal portion of the inlet tube and the distal portion of the outlet tube are positioned at an angle of at least 70 degrees relative to the proximal portion of the inlet tube and the proximal portion of the outlet tube, respectively; an applicator coupled to the distal portion of the inlet tube and the distal portion of the outlet tube, the applicator including an active face and a tapered tip, wherein the active face is configured to be in thermal contact with a tongue of a patient and the tapered tip is configured to reach a base of a vallecula of the patient, and wherein the active face has an arc length extending from a proximal end of the applicator to a distalmost end of the applicator, and a concavity of the active face increases in a distal direction along the arc length; and an arm coupled to the applicator, wherein at least a portion of the arm is positioned between the inlet tube and the outlet tube.2. The tongue cryoprobe of any one of the clauses herein, wherein the arm includes- an elongated portion,a distal end portion extending from the elongated portion, and a triggering mechanism including- a housing having a support interface extending in a direction normal to a length of the elongated portion, a pin positioned within the housing, and a switch coupled to the pin, such that, upon actuation of the switch, the pin releases and / or the distal end portion of the arm raises.3. The tongue cryoprobe of any one of the clauses herein, wherein the arm includes an elongated portion and a distal end portion, and wherein the distal end portion has a curvature that extends over a backside of the applicator.4. The tongue cryoprobe of any one of the clauses herein, wherein the arm includes an elongated portion and a distal end portion, and wherein at least a portion of the elongated portion is positioned in parallel to the proximal portion of the inlet tube and the proximal portion of the outlet tube.5. The tongue cry oprobe of any one of the clauses herein, further comprising a coupler coupling the arm to a backside of the applicator such that the arm is constrained to move on an X-Y plane.6. The tongue cry oprobe of any one of the clauses herein, further comprising one or more working channels coupled to a backside of the applicator, wherein an angle defined between the proximal portion of the inlet tube and / or the proximal portion of the outlet tube and a distal end portion of the one or more working channels is at least 60, 90, or 120 degrees.7. The tongue cry oprobe of any one of the clauses herein, further comprising one or more working channels coupled to a backside of the applicator, wherein an angle defined between the proximal portion of the inlet tube and / or the proximal portion of the outlet tube and a distal end portion of the one or more working channels is between 60 and 120 degrees.8. The tongue cry oprobe of any one of the clauses herein, further comprising one or more working channels coupled to a backside of the applicator, wherein an angle defined between the proximal portion of the inlet tube and / or the proximal portion of the outlet tube and a distal end portion of the one or more working channels is at least 60 degrees.9. The tongue cry oprobe of any one of the clauses herein, further comprising one or more working channels, wherein each working channel has a distal end positioned at an angle of at least 10, 45, or 80 degrees relative to a backside of the applicator.10. The tongue cryoprobe of any one of the clauses herein, further comprising one or more working channels, wherein each working channel has a distal end positioned at an angle of between 10 and 80 degrees relative to a backside of the applicator.11. The tongue cryoprobe of any one of the clauses herein, further comprising one or more working channels, wherein each working channel has a distal end positioned at an angle of at least 10 degrees relative to a backside of the applicator.12. The tongue cry oprobe of any one of the clauses herein, further comprising one or more working channels, wherein the one or more working channels have a cross-sectional dimension of at least 4, 5, 6, 7, or 8 millimeters.13. The tongue cryoprobe of any one of the clauses herein, further comprising one or more working channels, wherein the one or more working channels have a cross-sectional dimension between 4 and 8 millimeters.14. The tongue cryoprobe of any one of the clauses herein, further comprising one or more working channels, wherein the one or more working channels have a cross-sectional dimension of at least 4 millimeters.15. The tongue cryoprobe of any one of the clauses herein, further comprising a workingchannel assembly including- one or more working channels, a channel assembly base having one or more depressions configured to mate with the one or more working channels, one or more couplers configured to couple the channel assembly base to one or more attachment points on the applicator, and an insulator positioned on one or more sides of the applicator, the insulator surrounding the applicator such that only the active face of the applicator is exposed.16. The tongue cry oprobe of any one of the clauses herein, further comprising a working channel assembly including one or more working channels coupled to the applicator and to the arm, wherein a height of the working channel assembly is at most 15, 17, 20, 23, or 25 millimeters.17. The tongue cryoprobe of any one of the clauses herein, further comprising a working channel assembly including one or more working channels coupled to the applicator and to the arm, wherein a height of the working channel assembly is between 15 and 25 millimeters.18. The tongue cry oprobe of any one of the clauses herein, further comprising a working channel assembly including one or more working channels coupled to the applicator and to the arm, wherein a height of the working channel assembly is at most 25 millimeters.19. The tongue cry oprobe of any one of the clauses herein, further comprising a working channel assembly including one or more working channels coupled to the applicator and to the arm, wherein a distance from distalmost ends of the one or more working channels to the distalmost end of the applicator is at least 30, 35, 40, 45, or 50 millimeters.20. The tongue cryoprobe of any one of the clauses herein, further comprising a working channel assembly including one or more working channels coupled to the applicator and to the arm, wherein a distance from distalmost ends of the one or more working channels to the distalmost end of the applicator is between 30 and 50 millimeters.21. The tongue cry oprobe of any one of the clauses herein, further comprising a working channel assembly including one or more working channels coupled to the applicator and to the arm, wherein a distance from distalmost ends of the one or more working channels to the distalmost end of the applicator is at least 30 millimeters.22. The tongue cryoprobe of any one of the clauses herein, further comprising one or more working channels, wherein the one or more working channels are configured to supply a suction tube to a distal end of the applicator.23. The tongue cryoprobe of any one of the clauses herein, further comprising one or more working channels, wherein the one or more working channels are configured to supply a visualization tool to a distal end of the applicator.24. The tongue cryoprobe of any one of the clauses herein, further comprising one or more working channels, wherein the one or more working channels are configured to supply a suction tube or a visualization tool to a distal end of the applicator.25. The tongue cry oprobe of any one of the clauses herein, further comprising an insulator coupled to one or more sides of the applicator, wherein a flexible circuit is positioned between the insulator the applicator.26. The tongue cryoprobe of any one of the clauses herein, further comprising an insulator coupled to one or more sides of the applicator, wherein the insulator includes an indicator that extends down an intermediate portion of the insulator.27. The tongue cry oprobe of any one of the clauses herein, further comprising an insulator coupled to one or more sides of the applicator, wherein a fabric is between the insulator and the applicator.28. The tongue cryoprobe of any one of the clauses herein, further comprising an insulatorcoupled to one or more sides of the applicator, wherein the insulator includes one or more colored indicators, wherein, in operation, the one or more colored indicators assist in visualizing the applicator at the tongue.29. The tongue cryoprobe of any one of the clauses herein, further comprising an insulator coupled to one or more sides of the applicator, wherein the insulator includes an indicator that extends from a backside of the insulator to an opposite side of the insulator.30. The tongue cryoprobe of any one of the clauses herein, wherein the applicator includes- a sensor at the active face, a conductor electrically coupled to the sensor, and a backside configured to house one or more electronic components, wherein the conductor extends from the sensor (i) along the active face and (ii) along an edge of the applicator toward the backside of the applicator, such that the conductor electrically couples the sensor to the one or more electronic components.31. The tongue cryoprobe of any one of the clauses herein, wherein the active face of the applicator has a concave shape, and a backside portion of the applicator has a convex shape.32. The tongue cryoprobe of any one of the clauses herein, wherein a height of a side portion of the applicator is greatest at the proximal end of the applicator and decreases gradually towards the distalmost end of the applicator.33. The tongue cryoprobe of any one of the clauses herein, wherein the applicator includes an inlet, an outlet, and one or more attachment points extending from an intermediate portion of the applicator, wherein the intermediate portion is positioned at a first distance from a distal end of the applicator and at a second distance greater than the first distance from the inlet and the outlet.34. The tongue cryoprobe of any one of the clauses herein, wherein the proximal end ofthe applicator has a first height, and wherein a distal end of the applicator has a second height less than the first height.35. The tongue cryoprobe of any one of the clauses herein, wherein the arc length extending from the proximal end of the applicator to the distalmost end of the applicator is at least 45, 50, 55, 60, 65, or 70 millimeters.36. The tongue cryoprobe of any one of the clauses herein, wherein the arc length extending from the proximal end of the applicator to the distalmost end of the applicator is between 45 and 70 millimeters.37. The tongue cryoprobe of any one of the clauses herein, wherein the arc length extending from the proximal end of the applicator to the distalmost end of the applicator is at least 45 millimeters.38. The tongue cryoprobe of any one of the clauses herein, wherein the active face has surface area of at least 14, 14.4, 15.7, 16.4, 17.7, or 18 cm2.39. The tongue cryoprobe of any one of the clauses herein, wherein the active face has surface area between 14 and 18 cm2.40. The tongue cryoprobe of any one of the clauses herein, wherein the active face has surface area of at least 14 cm2.41. The tongue cryoprobe of any one of the clauses herein, wherein the applicator includes a hollow cavity including one or more protrusions that define one or more flow paths, wherein the one or more protrusions define at least one of (i) one or more U-shaped flow paths, (ii) one or more cross-fin flow paths, or (iii) a serpentine flow path.42. The tongue cryoprobe of any one of the clauses herein, wherein the applicator includes(i) an inlet passage configured to direct a temperature-controlled fluid from the inlet tube towards the active face and (ii) an outlet passage configured to direct the temperature-controlled fluid away from the active face towards the outlet tube.43. The tongue cryoprobe of any one of the clauses herein, wherein the applicator includes a base component and a treatment component adhesively coupled to the base component, wherein the treatment component includes the active face.44. The tongue cryoprobe of any one of the clauses herein, wherein the applicator includes a base component and a treatment component adhesively coupled to the base component, wherein the base component includes one or more depressions, and the treatment component includes one or more protrusions configured to mate with the one or more depressions.45. The tongue cry oprobe of any one of the clauses herein, wherein the applicator includes a base component and a treatment component adhesively coupled to the base component, and wherein the treatment component comprises steel, aluminum, and / or nitinol and the base component comprises a rigid plastic and / or a polymer.46. The tongue cry oprobe of any one of the clauses herein, wherein the applicator includes an inlet and outlet, wherein the inlet tube and the outlet tube are fluidically coupled to the inlet of the applicator and the outlet of the applicator by a coupling mechanism including- a first ferrule within the inlet tube and a second ferrule within the outlet tube, a first coupling member coupled to the distal portion of the inlet tube and to the inlet of the applicator, and a second coupling member coupled to the distal portion of the outlet tube and to the outlet of the applicator, wherein the first coupling member and the second coupling member are sized and shaped to wedge the first ferrule within the inlet tube and the second ferrule within the outlet tube.47. The tongue cry oprobe of any one of the clauses herein, wherein the applicator includes(i) a sensor at the active face and (ii) a conductor electrically coupled to the sensor and extending along the active face onto a backside of the applicator, the tongue cryoprobe further comprising: a working channel assembly including- one or more working channels, and a channel assembly base coupled to the backside of the applicator and configured to receive the one or more working channels, a triggering mechanism including- a housing translatable along a length of the arm, and a switch configured to actuate a pin within the housing, and an insulator positioned on one or more sides of the applicator, the insulator surrounding the applicator such that only the active face of the applicator is exposed.48. An applicator for treatment of obstructive sleep apnea, the applicator comprising: a hollow cavity including one or more protrusions that define one or more flow paths; an inlet at a proximal end of the applicator; an outlet at the proximal end of the applicator; an active face thermally coupled to the hollow cavity, wherein the active face is configured to contact a tongue of a patient; and one or more attachment points extending from an intermediate portion on a backside of the applicator, wherein the intermediate portion is positioned at a first distance from a distal end of the applicator and at a second distance, greater than the first distance, from the inlet and the outlet.49. The applicator of any one of the clauses herein, wherein the first distance is at most 10, 20, or 40 millimeters.50. The applicator of any one of the clauses herein, wherein the first distance is between 10 and 40 millimeters.51. The applicator of any one of the clauses herein, wherein the first distance is at most 40 millimeters.52. The applicator of any one of the clauses herein, wherein the second distance is at least 10, 20, or 40 millimeters.53. The applicator of any one of the clauses herein, wherein the second distance is between10 and 40 millimeters.54. The applicator of any one of the clauses herein, wherein the second distance is at least 10 millimeters.55. The applicator of any one of the clauses herein, wherein the first distance is at most 40 millimeters, and wherein the second distance is at least 10 millimeters.56. The applicator of any one of the clauses herein, wherein the proximal end of the applicator has a height of at most 5, 7, 9, 11, or 13 millimeters.57. The applicator of any one of the clauses herein, wherein the proximal end of the applicator has a height between 5 and 13 millimeters.58. The applicator of any one of the clauses herein, wherein the proximal end of the applicator has a height of at most 13 millimeters.59. The applicator of any one of the clauses herein, wherein the distal end of the applicator has a height of at most 1.75, 3.8, 5.8, 7.9, or 10 millimeters.60. The applicator of any one of the clauses herein, wherein the distal end of the applicator has a height between 1.75 and 10 millimeters.61. The applicator of any one of the clauses herein, wherein the distal end of the applicator has a height of at most 10 millimeters.62. The applicator of any one of the clauses herein, wherein the proximal end of the applicator has a height of at most 5 millimeters, wherein the distal end of the applicator has a height of at most 10 millimeters.63. The applicator of any one of the clauses herein, wherein the proximal end of the applicator includes a width of at most 25, 27, 30, 32, or 35 millimeters.64. The applicator of any one of the clauses herein, wherein the proximal end of the applicator includes a width between 25 and 35 millimeters.65. The applicator of any one of the clauses herein, wherein the proximal end of the applicator includes a width of at most 35 millimeters.66. The applicator of any one of the clauses herein, wherein the distal end of the applicator includes a width of at most 10, 12, 15, 17, or 20 millimeters.67. The applicator of any one of the clauses herein, wherein the distal end of the applicator includes a width between 10 and 20 millimeters.68. The applicator of any one of the clauses herein, wherein the distal end of the applicator includes a width of at most 20 millimeters.69. The applicator of any one of the clauses herein, wherein the proximal end of the applicator includes a width of at most 35 millimeters, and wherein the distal end of the applicator includes a width of at most 20 millimeters.70. The applicator of any one of the clauses herein, wherein (i) the inlet is configured todeliver a temperature-controlled fluid to the hollow cavity and (ii) the outlet is configured to remove the temperature-controlled fluid from the hollow cavity.71. The applicator of any one of the clauses herein, wherein the active face is an active surface configured to be in direct contact with a base of tongue of the patient.72. The applicator of any one of the clauses herein, wherein the active face is an active surface configured to be in direct contact with a base of tongue of the patient such that adipose cells at the base of tongue undergo adipose cryolysis.73. The applicator of any one of the clauses herein, wherein the active face is an active surface configured to be in direct contact with a lingual tonsil of the patient.74. The applicator of any one of the clauses herein, wherein the active face is an active surface configured to be in direct contact with a lingual tonsil of the patient such that surface lymphoid cells at the lingual tonsil undergo temperature-induced cell death.75. The applicator of any one of the clauses herein, wherein the distal end of the applicator is configured to reach a base of a vallecula of the patient.76. The applicator of any one of the clauses herein, further comprising a flexible circuit coupled to the active face of the applicator, wherein the active face is indented to receive the flexible circuit.77. The applicator of any one of the clauses herein, further comprising one or more sensors integrated into the active face, and wherein the one or more sensors integrated into the active face are at least one of a temperature sensor, a pressure sensor, a fluid flow sensor, a contact sensor, or an electrical impedance sensor.78. The applicator of any one of the clauses herein, wherein the one or more protrusionsdefine one or more U-shaped flow paths.79. The applicator of any one of the clauses herein, wherein the one or more protrusions define one or more cross-fin flow paths.80. The applicator of any one of the clauses herein, wherein the one or more protrusions define a serpentine flow path.81. The applicator of any one of the clauses herein, wherein the one or more protrusions define at least one of one or more U-shaped flow path, one or more cross-fin flow paths, or a serpentine flow path.82. The applicator of any one of the clauses herein, further comprising: a base component including the inlet, the outlet, and the one or more attachment points; and a treatment component adhesively coupled to the base component using a heat cure adhesive, wherein the treatment component includes the hollow cavity and the active face.83. The applicator of any one of the clauses herein, further comprising a base component including one or more depressions and a treatment component including the one or more protrusions, wherein the one or more protrusions mate with the one or more depressions.84. The applicator of any one of the clauses herein, further comprising a treatment component including steel, aluminum, and / or nitinol and a base component including a rigid plastic and / or a polymer.85. The applicator of any one of the clauses herein, further comprising a fabric between a treatment component and a base component.86. The applicator of any one of the clauses herein, further comprising a fabric configured to conform and / or complement the active face, wherein the fabric is soaked in a cryoprotectant agent.87. The applicator of any one of the clauses herein, further comprising a foam configured to conform and / or complement the active face, wherein the foam is soaked in a cryoprotectant agent.88. A system for treatment of obstructive sleep apnea, the system comprising: a thermal treatment unit; a conduit system fluidically coupled to the thermal treatment unit; and a tongue cryoprobe including- an inlet tube fluidically coupled to the conduit system, an outlet tube fluidically coupled to the conduit system, an applicator fluidically coupled to the inlet tube and the outlet tube, the applicator having- an active face with a sensor, and a conductor electrically coupled to the sensor extending across the active face, and an insulator disposed on one or more sides of the applicator and configured to surround the applicator such that only the active face is exposed.89. The system of any one of the clauses herein, further comprising a controller operably coupled to the thermal treatment unit and configured to direct a temperature-controlled fluid to the inlet tube in response to a reading from the sensor.90. The system of any one of the clauses herein, further comprising a controller operably coupled to the thermal treatment unit and configured to cause the thermal treatment unit to direct a temperature-controlled fluid to the inlet tube.91. The system of any one of the clauses herein, further comprising a controller is electrically coupled to the conductor and the sensor of the applicator.92. The system of any one of the clauses herein, further comprising a controller operably coupled to the thermal treatment unit and configured to initiate thermal treatment of a temperature-controlled fluid.93. The system of any one of the clauses herein, wherein the thermal treatment unit includes a temperature-controlled fluid, and wherein (i) the inlet tube is configured to direct the temperature-controlled fluid from the conduit system to the applicator and (ii) the outlet tube is configured to direct the temperature-controlled fluid from the applicator to the conduit system.94. The system of any one of the clauses herein, wherein the conduit system includes- a conduit, at least two fluid lines that extend within the conduit, wherein the at least two fluid lines are held in the conduit by one or more spacers, and a first coupling member fluidically coupling the thermal treatment unit to the at least two fluid lines and a second coupling member fluidically coupling the at least two fluid lines to the inlet tube and the outlet tube of the tongue cryoprobe.95. The system of any one of the clauses herein, wherein the conduit system includes a conduit housing at least two fluid lines and one or more coupling members coupled to one or more ends of the conduit, and wherein the one or more coupling members have a relief component configured to rotate relative to the conduit.96. The system of any one of the clauses herein, wherein the conduit system includes a conduit housing at least two fluid lines, and wherein the conduit thermally insulates the at least two fluid lines.97. The system of any one of the clauses herein, wherein the thermal treatment unit includes a temperature-controlled fluid, and wherein the temperature-controlled fluid is at most - 40°C, -30°C, -20°C, or -10°C.98. The system of any one of the clauses herein, wherein the thermal treatment unit includes a temperature-controlled fluid, and wherein the temperature-controlled fluid is between -40°C and -10°C.99. The system of any one of the clauses herein, wherein the thermal treatment unit includes a temperature-controlled fluid, and wherein the temperature-controlled fluid is at most - 10°C.100. The system of any one of the clauses herein, wherein the thermal treatment unit includes a heater and a chiller.101. The system of any one of the clauses herein, wherein the tongue cryoprobe includes an arm having a support interface, and wherein the support interface is configured to position the tongue cryoprobe adjacent to a patient.102. The system of any one of the clauses herein, wherein at least a portion of the conductor is covered by the insulator.103. The system of any one of the clauses herein, wherein at least a portion of the conductor extends onto a backside of the applicator, and wherein the portion of the conductor that extends onto the backside of the applicator is covered by the insulator.104. A method for treatment of obstructive sleep apnea, the method comprising: positioning a tongue cryoprobe, the tongue cryoprobe comprising an applicator and an arm having a triggering mechanism, into an oral cavity of a patient such that at least a portion of the applicator covers a tongue of the patient, distally pushing the triggering mechanism along a length of the arm such that tension is applied to pull a distal end of the arm upward; providing traction between the applicator and the tongue; circulating a thermally treated fluid through the tongue cryoprobe; proximally pulling the triggering mechanism along the length of the arm to terminate the traction between the applicator and the tongue; andremoving the tongue cryoprobe from the oral cavity.105. The method of any one of the clauses herein, further comprising attaching a support interface of the triggering mechanism to a fixation arm to secure the tongue cry oprobe adjacent to the patient throughout the treatment.106. The method of any one of the clauses herein, wherein distally pushing the triggering mechanism causes a pin of the triggering mechanism to be disengaged and activates the triggering mechanism.107. The method of any one of the clauses herein, wherein proximally pulling the triggering mechanism re-engages a pin of the triggering mechanism and recharges the triggering mechanism for subsequent use.
Claims
CLAIMSI / We claim:
1. A tongue cryoprobe, comprising: an inlet tube including a proximal portion and a distal portion; an outlet tube including a proximal portion and a distal portion, wherein the distal portion of the inlet tube and the distal portion of the outlet tube are positioned at an angle of at least 70 degrees relative to the proximal portion of the inlet tube and the proximal portion of the outlet tube, respectively; an applicator coupled to the distal portion of the inlet tube and the distal portion of the outlet tube, the applicator including an active face and a tapered tip, wherein the active face is configured to be in thermal contact with a tongue of a patient and the tapered tip is configured to reach a base of a vallecula of the patient, and wherein the active face has an arc length extending from a proximal end of the applicator to a distalmost end of the applicator, and a concavity of the active face increases in a distal direction along the arc length; and an arm coupled to the applicator, wherein at least a portion of the arm is positioned between the inlet tube and the outlet tube.
2. The tongue cryoprobe of claim 1, wherein the arm includes- an elongated portion, a distal end portion extending from the elongated portion, and a triggering mechanism including- a housing having a support interface extending in a direction normal to a length of the elongated portion, a pin positioned within the housing, and a switch coupled to the pin, such that, upon actuation of the switch, the pin releases and / or the distal end portion of the arm raises.
3. The tongue cry oprobe of claim 1, wherein the arm includes an elongated portion and a distal end portion, and wherein the distal end portion has a curvature that extends over a backside of the applicator.
4. The tongue cryoprobe of claim 1, wherein the arm includes an elongated portion and a distal end portion, and wherein at least a portion of the elongated portion is positioned in parallel to the proximal portion of the inlet tube and the proximal portion of the outlet tube.
5. The tongue cryoprobe of claim 1, further comprising a coupler coupling the arm to a backside of the applicator such that the arm is constrained to move on an X-Y plane.
6. The tongue cry oprobe of claim 1, further comprising one or more working channels coupled to a backside of the applicator, wherein an angle defined between the proximal portion of the inlet tube and / or the proximal portion of the outlet tube and a distal end portion of the one or more working channels is at least 60 degrees.
7. The tongue cryoprobe of claim 1, further comprising one or more working channels, wherein each working channel has a distal end positioned at an angle of at least 10 degrees relative to a backside of the applicator.
8. The tongue cryoprobe of claim 1, further comprising one or more working channels, wherein the one or more working channels have a cross-sectional dimension of at least 4 millimeters.
9. The tongue cryoprobe of claim 1, further comprising a working channel assembly including- one or more working channels, a channel assembly base having one or more depressions configured to mate with the one or more working channels, one or more couplers configured to couple the channel assembly base to one or more attachment points on the applicator, andan insulator positioned on one or more sides of the applicator, the insulator surrounding the applicator such that only the active face of the applicator is exposed.
10. The tongue cryoprobe of claim 1, further comprising a working channel assembly including one or more working channels coupled to the applicator and to the arm, wherein a height of the working channel assembly is at most 25 millimeters.
11. The tongue cryoprobe of claim 1 , further comprising an insulator coupled to one or more sides of the applicator, wherein a flexible circuit is positioned between the insulator the applicator.
12. The tongue cryoprobe of claim 1, further comprising an insulator coupled to one or more sides of the applicator, wherein the insulator includes an indicator that extends down an intermediate portion of the insulator.
13. The tongue cry oprobe of claim 1, wherein the applicator includes- a sensor at the active face, a conductor electrically coupled to the sensor, and a backside configured to house one or more electronic components, wherein the conductor extends from the sensor (i) along the active face and (ii) along an edge of the applicator toward the backside of the applicator, such that the conductor electrically couples the sensor to the one or more electronic components.
14. The tongue cryoprobe of claim 1, wherein a height of a side portion of the applicator is greatest at the proximal end of the applicator and decreases gradually towards the distalmost end of the applicator.
15. The tongue cry oprobe of claim 1, wherein the arc length extending from the proximal end of the applicator to the distalmost end of the applicator is at least 45 millimeters.
16. The tongue cry oprobe of claim 1, wherein the active face has surface area of at least14 cm2.
17. The tongue cryoprobe of claim 1, wherein the applicator includes a hollow cavity including one or more protrusions that define one or more flow paths, wherein the one or more protrusions define at least one of (i) one or more U-shaped flow paths, (ii) one or more cross-fin flow paths, or (iii) a serpentine flow path.
18. The tongue cryoprobe of claim 1, wherein the applicator includes an inlet and outlet, wherein the inlet tube and the outlet tube are fluidically coupled to the inlet of the applicator and the outlet of the applicator by a coupling mechanism including- a first ferrule within the inlet tube and a second ferrule within the outlet tube, a first coupling member coupled to the distal portion of the inlet tube and to the inlet of the applicator, and a second coupling member coupled to the distal portion of the outlet tube and to the outlet of the applicator, wherein the first coupling member and the second coupling member are sized and shaped to wedge the first ferrule within the inlet tube and the second ferrule within the outlet tube.
19. The tongue cry oprobe of claim 1, wherein the applicator includes (i) a sensor at the active face and (ii) a conductor electrically coupled to the sensor and extending along the active face onto a backside of the applicator, the tongue cry oprobe further comprising: a working channel assembly including- one or more working channels, and a channel assembly base coupled to the backside of the applicator and configured to receive the one or more working channels, a triggering mechanism including- a housing translatable along a length of the arm, and a switch configured to actuate a pin within the housing, andan insulator positioned on one or more sides of the applicator, the insulator surrounding the applicator such that only the active face of the applicator is exposed.
20. An applicator for treatment of obstructive sleep apnea, the applicator comprising: a hollow cavity including one or more protrusions that define one or more flow paths; an inlet at a proximal end of the applicator; an outlet at the proximal end of the applicator; an active face thermally coupled to the hollow cavity, wherein the active face is configured to contact a tongue of a patient; and one or more attachment points extending from an intermediate portion on a backside of the applicator, wherein the intermediate portion is positioned at a first distance from a distal end of the applicator and at a second distance, greater than the first distance, from the inlet and the outlet.
21. The applicator of claim 20, wherein the first distance is at most 40 millimeters, and wherein the second distance is at least 10 millimeters.
22. The applicator of claim 20, wherein the proximal end of the applicator has a height of at most 5 millimeters, wherein the distal end of the applicator has a height of at most 10 millimeters.
23. The applicator of claim 20, wherein the proximal end of the applicator includes a width of at most 35 millimeters, and wherein the distal end of the applicator includes a width of at most 20 millimeters.
24. A system for treatment of obstructive sleep apnea, the system comprising: a thermal treatment unit; a conduit system fluidically coupled to the thermal treatment unit; and a tongue cryoprobe including- an inlet tube fluidically coupled to the conduit system, an outlet tube fluidically coupled to the conduit system,an applicator fluidically coupled to the inlet tube and the outlet tube, the applicator having- an active face with a sensor, and a conductor electrically coupled to the sensor extending across the active face, and an insulator disposed on one or more sides of the applicator and configured to surround the applicator such that only the active face is exposed.
25. The system of claim 24, further comprising a controller operably coupled to the thermal treatment unit and configured to direct a temperature-controlled fluid to the inlet tube in response to a reading from the sensor.
26. The system of claim 24, wherein the conduit system includes- a conduit, at least two fluid lines that extend within the conduit, wherein the at least two fluid lines are held in the conduit by one or more spacers, and a first coupling member fluidically coupling the thermal treatment unit to the at least two fluid lines and a second coupling member fluidically coupling the at least two fluid lines to the inlet tube and the outlet tube of the tongue cry oprobe.
27. A method for treatment of obstructive sleep apnea, the method comprising: positioning a tongue cryoprobe, the tongue cryoprobe comprising an applicator and an arm having a triggering mechanism, into an oral cavity of a patient such that at least a portion of the applicator covers a tongue of the patient, distally pushing the triggering mechanism along a length of the arm such that tension is applied to pull a distal end of the arm upward; providing traction between the applicator and the tongue; circulating a thermally treated fluid through the tongue cryoprobe; proximally pulling the triggering mechanism along the length of the arm to terminate the traction between the applicator and the tongue; andremoving the tongue cryoprobe from the oral cavity.
28. The method of claim 27, further comprising attaching a support interface of the triggering mechanism to a fixation arm to secure the tongue cryoprobe adjacent to the patient throughout the treatment.
29. The method of claim 27, wherein distally pushing the triggering mechanism causes a pin of the triggering mechanism to be disengaged and activates the triggering mechanism.
30. The method of claim 27, wherein proximally pulling the triggering mechanism reengages a pin of the triggering mechanism and recharges the triggering mechanism for subsequent use.
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