Soft palate cryoprobes for treatment of obstructive sleep apnea, and associated systems, devices and methods
The sleep apnea treatment system with a soft palate cryoprobe and thermal treatment unit addresses the limitations of existing OSA treatments by offering a minimally invasive, cost-effective, and safer method for adipose cell death, reducing complications and expanding accessibility.
Patent Information
- Application Number
- PCT/US2025/032063
- 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 existing cryolysis methods non-selectively destroy tissue, posing further risks to surrounding healthy tissues.
A minimally invasive sleep apnea treatment system using a soft palate cryoprobe with onboard electronics and a thermal treatment unit to deliver temperature-controlled fluid, allowing precise adipose cell death via cooling or heating, reducing tissue damage and broadening the range of physicians capable of performing the procedure.
The system provides a more permanent solution to OSA by minimizing patient discomfort, reducing recovery time, and lowering surgical complication risks, making it accessible to a broader range of healthcare providers at a lower cost than CPAP.
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Figure US2025032063_11122025_PF_FP_ABST
Abstract
Description
SOFT PALATE CRYOPROBES FOR TREATMENT OF OBSTRUCTIVESLEEP APNEA, 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 / 655,537, filed June 3, 2024, and titled “SOFT PALATE 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 / 655,555, [Attorney Docket No.151139.8010.US00], filed June 3, 2024, and titled “TONGUE CRYOPROBES FOR TREATMENT OF OBSTRUCTIVE SLEEP APNEA, AND ASSOCIATED SYSTEMS, DEVICES AND METHODS”; and International Patent Application No. TBD [Attorney Docket No.151139.8010.WO00], filed TBD, and titled “TONGUE CRYOPROBES FOR TREATMENT OF OBSTRUCTIVE SLEEP APNEA, AND ASSOCIATED SYSTEMS, DEVICES AND METHODS”.TECHNICAL FIELD
[0002] This present technology relates to soft palate 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. CPAP delivers a stream of compressed air to keep the airway open but is not a permanent solution and isassociated 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 cryoprobe, in accordance with embodiments of the present technology.
[0007] FIG. 2 shows the thermal treatment unit of FIG. 1.
[0008] FIGS. 3A-3D show various views of a soft palate cryoprobe, in accordance with embodiments of the present technology.
[0009] FIG. 4 shows a housing of a soft palate cryoprobe, in accordance with embodiments of the present technology.
[0010] FIGS. 5 A and 5B show an applicator of the soft palate cryoprobe of FIG. 3 A.
[0011] FIG. 5C shows a treatment component of the applicator of FIGS. 5A and 5B.
[0012] FIG. 6 shows a ferrule coupling mechanism, in accordance with embodiments of the present technology.
[0013] FIG. 7 shows a housing and a flexible circuit integrated with onboard electronics of a soft palate cryoprobe, in accordance with embodiments of the present technology.
[0014] FIG. 8 shows a fabric shaped for an applicator, in accordance with embodiments of the present technology.
[0015] FIGS. 9A and 9B show an applicator with fabric integration, in accordance with embodiments of the present technology.
[0016] FIG. 10 shows a handle with an axial support interface, in accordance with embodiments of the present technology.
[0017] FIG. 11 shows a handle with a radial support interface, in accordance with embodiments of the present technology.
[0018] FIGS. 12A-12D show various views of a conduit system, in accordance with embodiments of the present technology.
[0019] FIGS. 13A-13D show various views of a coupling member, in accordance with embodiments of the present technology.
[0020] FIG. 14 shows an insulator, in accordance with embodiments of the present technology.
[0021] FIGS. 15A and 15B show an insulating pad of an insulator, in accordance with embodiments of the present technology.
[0022] FIGS. 16A-16D show a contact indicator of an insulator, in accordance with embodiments of the present technology.
[0023] FIG. 17 shows a kit for a sleep apnea treatment system, in accordance with embodiments of the present technology.
[0024] FIGS. 18A-18D show procedural stages for thermally treating the oropharyngeal area, in accordance with embodiments of the present technology.
[0025] FIGS. 19-22 show various visualization aids, in accordance with embodiments of the present technology.
[0026] 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
[0027] 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, which includes the retropalatal and retrolingual areas of the oral cavity. The retropalatal areas include the back part 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 oropharynx. 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.
[0028] Technologies used to treat OSA include non-invasive devices such as continuous positive air pressure (CPAP) and mandibular advancement devices (MAD), as well as surgical modifications 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 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.
[0029] 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.
[0030] 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.
[0031] 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.
[0032] 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 soft palate cryoprobe configured to treat a soft palate, a thermal treatment unit configured to store, generate, and / or deliver a chilled or heated fluid to the soft palate cryoprobe via a conduit system, and a controller electrically coupled to the soft palate cryoprobe and the thermal treatment unit.
[0033] The soft palate cryoprobe can include one or more fluid tubes, a handle coupled to the one or more fluid tubes, and an applicator coupled to the handle. The handle can be coupled to the applicator at an angle that enables a user (e.g., a physician, healthcare professional, or other personnel) to position the soft palate cryoprobe on the soft palate. For example, the handle is coupled to theapplicator at an angle equivalent to the position of the soft palate relative to the length of the handle when the soft palate cryoprobe is within the patient’s mouth. The position of the applicator relative to the handle can reduce the time the user spends positioning the soft palate cryoprobe, and thus, the length of the surgical procedure. In some embodiments, the one or more fluid tubes include inlet and outlet tubes positioned to direct temperature-controlled 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 target area. For example, the applicator surface cools the soft palate without using surgical techniques typically associated with adipose cryolysis (e.g., cryolitic ablation). 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 soft palate cryoprobe can direct a heated fluid to and from an active surface of the applicator following administration of the temperature-controlled fluid. The thermal treatment unit can deliver the 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 the heated fluid to the applicator to remove ice formation on the target area before the patient experiences frostbite.
[0034] The applicator can further include a flexible circuit (e.g., conductor) electrically coupled to one or more temperature sensors on a distal 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, e.g., in the handle of the cryoprobe. The onboard electronics can process and convert measurements from the one or more temperature sensors, reducing the wires that arc coupled to the soft palate 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, thereby enhancing 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 changethe type or characteristics of temperature sensors without changing the interface and / or the ability to individually calibrate temperature sensors in manufacturing.
[0035] 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 soft palate 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 (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 soft palate 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.
[0036] 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., chilled and / or heated fluid) from the thermal treatment unit to the soft palate 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 soft palate cryoprobe, providing more efficient fluid delivery to the applicator, and thus, more efficient cooling of the target area.
[0037] 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 probes that physicians can select to treat more than one site of airway obstruction (e.g., excess fat cells at the BoT, lateral wall, epiglottis, etc.). For example, the physician can select a tongue cryoprobe to treat the tongue in addition to the soft palate cryoprobc that treats the soft palate, therebyreducing cells at more than one site of obstruction. In some embodiments, the probes 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 applicator, and the surface temperature of the tongue applicator causes temperature induced cell death at the lingual tonsils. The physician can use both probes 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.
[0038] 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 the disclosure. 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)
[0039] 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 coupledto 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 (referred to collectively as “coupling members 120”) at opposing ends of the conduit 118 that arc 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.
[0040] 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, the applicator 102 is sized and shaped to contact the soft palate, as described in more detail with reference to FIGS. 5 A and 5B. 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.
[0041] 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 cryoprobe 105. For example, the thermaltreatment 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 cry oprobe 105. The configuration of the thermal treatment unit 106 can be described in more detail with reference to FIG. 2.
[0042] 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 operations of 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 122outputs 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).
[0043] 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. 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.
[0044] 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 the temperature-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 temperatureof 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. Soft Palate Probes for Treatment of OSA
[0045] FIGS. 3A-3D show a soft palate cryoprobe 300 (e.g., the cryoprobe 105 of FIG. 1). Specifically, FIG. 3A shows an isometric view of the soft palate cryoprobe 300, FIG. 3B shows a bottom- up view of the soft palate cry oprobe 300, FIG. 3C shows a side view of the soft palate cryoprobe 300, and FIG. 3D shows a top view of a portion of the soft palate cryoprobe 300. As shown in FIG. 3A, the soft palate cryoprobe 300 can include a housing 310, and an applicator 350 coupled to and at a distal end portion 370 of the housing 310. The soft palate cryoprobe can further include an inlet tube 325 and an outlet tube 345. The inlet tube 325 and the outlet tube 345 include respective proximal ends 320, 340, and can extend through a portion or an entire length of the housing 310. The soft palate cryoprobe 300 can be electrically coupled to one or more electrical lines 315 by a junction 335 such that the electrical lines 315 can electrically couple the soft palate cryoprobe 300 to a controller (e.g., the controller 122). The electrical lines 315 can be electrically coupled to one or more of electrical components of the soft palate cryoprobe 300 to transmit signals from the electrical components and / or to provide power to the electrical components, as described in more detail with reference to FIGS. 5A and 7. Additionally or alternatively, 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).
[0046] The applicator 350 can further include a collar or coupling member 355 that couples the applicator 350 to the distal end portion 370 of the housing 310. In some embodiments, the inlet tube325 and the outlet tube 345 are fluidically coupled to the applicator 350 by the coupling member 355, as described in more detail with reference to FIGS. 3D and 6. In some embodiments, the inlet tube 325 directs the temperature-controlled fluid from the conduit to the applicator 350, and the outlet tube 345 directs the temperature-controlled fluid away from the applicator back to the conduit. Furthermore, the coupling member 355 can be coupled to the distal end portion 370 at an angle that positions the applicator 350 onto the soft palate, as described in more detail with reference to FIG. 3C. The housing 310 can further include a support interface 380. The support interface 380 can be coupled to the soft palate cryoprobe 300 and a positioning arm (e.g., the fixation arm 112 of FIG. 1) that holds the soft palate cry oprobe 300 adjacent to the patient during treatment.
[0047] FIG. 3B shows a back view of the soft palate cryoprobe 300 including a flexible circuit 360 (e.g., conductor). The flexible circuit 360 can span from the backside 1 of the housing 310 over the distal end portion 370 and the coupling member 355 onto a face of the applicator 350. As shown in FIG. 3, the circuit 360 can extend from the applicator 350 along a direction parallel or substantially parallel to a length of the housing 310. The flexible circuit 360 can be electrically coupled to onboard electronics within the housing 310. For example, the backside 327 of the housing 310 includes a Printed Circuit Board Assembly (PCBA) that is electrically coupled to the flexible circuit 360. Additionally or alternatively, the flexible circuit 360 can be electrically coupled to one or more sensors on the surface of the applicator 350. For example, as described in more detail with reference to FIGS. 5A and 7, the flexible circuit 360 provides electrical current to a thermistor on the surface of the applicator 350, and the thermistor is used to monitor the temperature of the soft palate throughout treatment. The onboard electronics can process and convert measurements from the one or more temperature sensors, reducing the wires that couple the soft palate cryoprobe to the controller, thereby reducing the equipment around the patient throughout the surgical procedure. The flexible circuit 360 and the one or more sensors can monitor temperature at the target area to maintain cryolitic conditions (e.g., temperatures between -30°C and 10°C) and / or to prevent damage associated with excess cooling at the target area.
[0048] FIG. 3C shows a side view of the soft palate cryoprobe 300. As shown in FIG. 3C, the applicator 350 can be angled at an angle a relative to an axis parallel to a length of the housing 310. The angle a can be between 5° and 50° or any degree therebetween (e.g., 20°, 22°, 25°, etc.), or at least 5°, 10°, 20°, 30°, 40°, or 50°. In some embodiments, the angle a is equivalent to the position ofthe soft palate relative to the housing 310 when the soft palate cryoprobe 300 is inserted into a patient’s mouth. Thus, when the soft palate cryoprobe 300 is inserted into the patient’s mouth, the applicator 350 can make direct contact with the soft palate without needing to adjust the position of the housing 310 and / or the applicator 350. The angle of the applicator 350 relative to the housing 310 is described in more detail with reference to FIG. 18B, which describes insertion of the soft palate cryoprobe 300.
[0049] FIG. 3D shows a top view of the soft palate cryoprobe 300 looking directly down the inlet tube 325 and the outlet tube 345. The inlet tube 325 and the outlet tube 345 can have a first cross- sectional dimension (DI), and can further include ferrules 397a and 397b (e.g., oval-shaped ferules) (referred to collectively as “ferrules 397”) that have a second cross-sectional dimension (D2). The inlet tube 325 and the outlet tube 345 can extend throughout a portion of or the entire length of the housing 310 and can be fluidically coupled to the applicator 350 by the coupling member 355 and the ferrules 397, as described in more detail with reference to FIG. 6. In some embodiments, DI is between 0.5 cm and 1.5 cm or any dimension therebetween, or at least 0.5 cm, 0.75 cm, 0.82 cm, 1.2 cm, or 1.5 cm and D2 is between 0.4 cm and 1.4 cm or any dimension therebetween, or at least 0.4 cm, 0.65 cm, 0.775 cm, 1.1 cm, or 1.4 cm. In some embodiments, DI is generally small enough such that the inlet tube 325 and the outlet tube 345 can fit within the housing 310, and D2 can be generally small enough such that the ferrules 397 can fit within the inlet tube 325 and the outlet tube 345. As further shown in FIG. 3D, the applicator 350 can have a first width (Wl) and the housing 310 can have a second width (W2) less than the first width (W2). Wl can be between 3.8 cm and 4.6 cm or any width therebetween, or at least 3.8 cm, 4.2 cm, or 4.6 cm that will fit within the oral cavity, and W2 can be between 1.9 and 2.9 cm, or any width therebetween less than that Wl. In some embodiments, the housing 310 is generally slimmer than the applicator 350, facilitating enhanced visualization of the applicator 350 as the user inserts the soft palate cryoprobe 300 into the patient’s mouth and / or positions the applicator 350 onto the soft palate, reducing the time spent adjusting the soft palate cryoprobe, and thus, the length of the surgical procedure.
[0050] FIG. 4 shows a housing 410 of a soft palate cryoprobe. The housing 410 can include any features or functionality of the housing 310 of the soft palate cryoprobe 300 of FIGS. 3A-3D except that the housing 410 omits a support interface (e.g., the support interface 380) for clarity purposes. As shown in FIG. 4, the housing 410 can include a cover component 451 and a basecomponent 452. The cover component 451 can be coupled to the base component 452, e.g., using a press-pin mechanism. The base component 452 can include one or more pins 460a-460d (referred to collectively as “pins 460”). The cover component 451 can include one or more openings 465a-465d (referred to collectively as “openings 465”). The pins 460 can be configured to fit inside the openings 465 such that the housing 410 can encase the inlet tube 425 and the outlet tube 445 along a length (LI). In some embodiments, the press-pin mechanism simplifies assembly of the housing 410 by allowing the user to couple the cover component 451 to the base component 452 quickly and efficiently without the need for additional materials. Additionally or alternatively, the cover component 451 and the base component 452 of the housing 410 can be combined by one or more coupling mechanisms including joints, screws, adhesive, and / or the like. The cover component 451 and / or the base component 452 can be made of metal, polymers, or other materials (c.g., aluminum, stainless steel, polyphenylene sulfide (PPS), plastic, and / or nitinol) suitable for contacting the oropharyngeal area. In some embodiments, the cover component 451 and the base component 452 are made of the same material. Additionally or alternatively, the cover component 451 and the base component 452 can be made of different materials.
[0051] FIGS. 5A and 5B show the applicator 350 of the soft palate cryoprobe 300 of FIGS. 3A- 3D. As shown in FIG. 5A, the applicator 350 can include a distal face 557, and a side surface 555 adjacent to and extending proximally from the distal face 557. The distal face 557 has a third crosssurface dimension (D3) along a short axis and a fourth cross-surface dimension (D4) along a long axis normal to the short axis. As shown in FIG. 5A, the distal face 557 can be curved along the fourth cross-surface dimension (D4) such that a distalmost end (i.e. , relative to the housing 310) of the distal face 557 is at an intermediate portion of the distal face 557. Stated differently, peripheral portions of the distal face 557 on surrounding sides of the intermediate portion are proximal (i.e., relative to the housing 310) to the intermediate portion. Additionally, a cross-surface dimension of the distal face 557 at the intermediate portion can be greater than a fifth cross-surface dimension (D5) of the distal face 557 at either of the peripheral portions. As shown in FIG. 5A, the distal face 557 can also be curved along the short axis. D3 can be a cross-surface dimension between 21 mm and 23 mm, or any dimension therebetween, or at most 21 mm, 22 mm, or 23 mm, D4 can be a cross-surface dimension between 42 mm and 45 mm, or any dimension therebetween, or at most 42 mm, 43.5 mm, or 45 mm,and D5 can be a dimension between 11 mm and 13 mm, or any dimension therebetween, or at most 11 mm, 12 mm, or 13 mm.
[0052] The side surface 555 extends around a proximal end of the distal face 557 between the distal face 557 and a base of the applicator 350. As shown in FIG. 5A and 5B, the side surface 555 comprise and / or consist of (i) an upper portion 572a (e.g., a first portion) that can have a convex shape, (ii) a backside portion 572b (e.g., a second portion) that can have a concave shape, and (iii) opposing side-end portions 572c, 572d (e.g., third and fourth portions) each extending from and between the upper portion and backside portion and that have concave shapes. As shown in FIG. 5 A, a height (Hl) of the side surface 555 between a base 587 of the applicator 350 and a corresponding point of the distal face 557 can be greatest at a center or intermediate area of the backside portion, and decease in height (H2 and H3) in a direction approaching the opposing side-end portions 572c, 572d. Hl can be a height between 8 mm and 10 mm, or any height therebetween, or at most 8 mm, 9 mm, or 10 mm, H2 can be a height between 6 mm and 8 mm, or any height therebetween, or at most 6 mm, 7 mm, or 8 mm, and H3 can be a height between 4 mm and 6 mm, or any height therebetween, or at most 4 mm, 5 mm, or 6 mm. Such heights correspond to a shape of the applicator 350, or more specifically a shape of the distal face 557, that maximizes a surface area in contact with the soft palate or other target area of the patient.
[0053] The applicator 350 can further include a flexible circuit 360 and one or more sensors 570 disposed on the distal face 557. The flexible circuit 360 extends along the distal face 557, to and along the side surface 555, and then proximally toward the handle of the soft palate cryoprobe 300. As shown in FIG. 5A, the flexible circuit 360 can extend along the second portion of the side surface 555 having a concave shape. As shown in FIG. 5B, the distal face 557, side surface 555 and other areas of the applicator 350 can include in indent corresponding to a shape of the flexible circuit 360, such that, when coupled to the applicator 350, the distal face 557, side surface 555, and other areas of the applicator 350 are generally planar. As described in more detail with reference to FIG. 7, the flexible circuit 360 is electrically coupled to the sensors 570 and other electrical components incorporated into the housing 310.
[0054] The coupling member 355 can be coupled to the distal end portion 370 of the housing 310 such that the inlet tube (e.g., the inlet tube 325 of FIG. 3A) can guide the temperature-controlled fluid into the applicator 350 and the outlet tube (e.g., the outlet tube 345 of FIG. 3A) can guide thetemperature-controlled fluid out of the applicator 350. The applicator 350 can be configured to evenly distribute the temperature-controlled fluid throughout the applicator 350. In some embodiments, the temperature-controlled fluid within the applicator 350 creates an active surface at the distal face 557, which is in thermal contact with the soft palate. The distal face 557 can have a curvature that is shaped to conform to and / or complement in part the soft palate such that the applicator 350 makes even or more contact with the entire soft palate.
[0055] The sensors 570 can be used to monitor thermal treatment of the soft palate. In some embodiments, the sensors 570 are temperature sensors (e.g., thermistors) that record temperature measurements at the distal face 557. The sensors 570 can be electronically coupled to a controller (e.g., the controller 122 of FIG. 1), and the controller can change the flow rate of temperature- controlled fluid flowing to the applicator 350 based on the temperature measured by the sensors 570. For example, if the sensors 570 measure that the surface temperature of the distal face 557 is generally too high to cause adipose cell death by adipose cryolysis at a depth of 1 cm (e.g., above a temperature between -30°C to 10°C), the flow rate of 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. Additionally or alternatively, the sensors 570 can include pressure sensors, fluid flow sensors, contact sensors, and / or electrical impedance sensors attached to the distal face 557. 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 distal face 557 is making even contact with the soft palate, thereby, optimizing cooling at the target area throughout thermal treatment and shortening the overall procedure. In some embodiments, it is advantageous to monitor temperature at the soft palate to prevent damage associated with excess cooling at the target area, thereby increasing the patient’s likelihood of a generally faster recovery.
[0056] 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 soft palate, cooling the target area to 10°C for at least 15 minutes creates a transmural cooling that causes adipose cryolysis to a majority of the adipose cells at the target area. 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’scondition. Thus, the system can reduce a volume of adipose cells at the target area without the use of invasive surgical techniques.
[0057] As described above, the flexible circuit 360 can extend along the distal face 557, to and along the side surface 555, and then proximally toward the housing 310. Additionally or alternatively, the flexible circuit 360 can extend to and along the side surface 555 in various configurations that allow the handle of the soft palate cryoprobe (e.g., the housing 310 of FIGS. 3A-3D) to move freely without affecting the electrical components of the flexible circuit 360. In operation, the user can place the distal face 557 of the applicator 350 onto the soft palate, but exact placement of the distal face 557 can change depending on the patient’s anatomy. The coupling member 355 can be coupled to the housing 310 such that the user can use the housing 310 to manually position or reposition the applicator 350 to make complete contact with the soft palate, as described in more detail with reference to FIG. 18 A. The user can repeat the process of positioning and / or repositioning the soft palate cryoprobe another number of times based on, the readings from the sensors 570, imaging, visualization of the soft palate, and / or treatment steps to be performed.
[0058] As shown in FIG. 5B, the applicator 350 can include base component 552 (e.g., a first component), and a treatment component 551 (e.g., a second component) removably coupled to the base component 552. The base component 552 can include a base surface facing distally toward the distal face 557 of the treatment component 551, a base member 580 that extends or protrudes outwards away from the base surface of the base component 552, and the coupling member 355 of FIGS. 3A- 3D and that extends outwards in an opposite direction of the base member 580. The base member 580 can include couplers 590a and 590b (referred to collectively as “couplers 590”) that extend distally from the base member 580 towards a distal face 557 of the treatment component 551. The base member 580 can further include a ring 585 (e.g., a silicone O-ring) disposed around the base member 580 and / or in contact with the base surface. In some embodiments, the couplers 590 and the ring 585 are coupled to the treatment component 551. The base member 580 can further include an inlet passage 525 and an outlet passage 545. In some embodiments, the inlet passage 525 and the outlet passage 545 are hollow passageways configured to receive the inlet tube 325 and the outlet tube 345 of the soft palate cryoprobe 300 of FIGS. 3A-3D. Additionally or alternatively, the treatment component 551 and the base component 552 can be combined by one or more coupling mechanisms including joints, screws, adhesive, and / or the like. In some embodiments, the couplers 590 and thering 585 simplify assembly and / or manufacturing of the applicator (e.g., the applicator 350 of FIGS. 3A-3D) by allowing the user to couple the treatment component 551 to the base component 552 more readily than other attachment mechanisms (e.g., heat cure adhesive).
[0059] The treatment component 551 and / or the base component 552 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 soft palate. The treatment component 551 and the base component 552 are made of the same or different materials. For example, the treatment component 551 is made of a metal (e.g., aluminum) and the base component 552 is made of a plastic polymer (e.g., polyphenylsulfone (PPSU) or Radel, Udel, and / or polyarylamide (IXEF)). It can be advantageous to make the treatment component 551 out of metal and the base component 552 out of plastic 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 350 and the soft palate occurs at the distal face 557 (e.g., the active surface). This improves the heat transfer efficiency of the applicator 350 while also imparting an insulating effect to the distal face 557. This can reduce the need for an extra insulating layer, such as a foam, which in turn can decrease the overall size of the applicator 350. Utilizing a plastic for the base component 552 also allows the parts to be made with injection molding, which reduces costs and allows for rapid mass manufacturing of parts.
[0060] It can be advantageous to have the base component 552 made of a plastic that has a thermal expansion coefficient similar’ to the material used on the treatment component 551. For example, PPSU has a coefficient of thermal expansion that is very similar to aluminum, and thus, if the treatment component 551 and the base component 552 are temperature cycled, they will experience similar’ deformation. If the treatment component 551 and the base component 552 are made of two materials that have dissimilar- coefficients of thermal expansion, then the treatment component 551 and the base component 552 can deform, the fastening of the components can loosen or break, and / or cracks can form in the components. If the fastening of the applicator 350 loosens, breaks, and / or cracks form in the components, the temperature-controlled fluid can leak out of the applicator 350 and disrupt treatment. In some embodiments, the treatment component 551 and the base component 552 are also unaffected by the temperature-controlled fluid administered to theapplicator 350. For example, aluminum and PPSU are unaffected by the temperature-controlled fluid (e.g., ethanol, glycerol, etc.). In some embodiments, the treatment component 551 and the base component 552 are made of the same material.
[0061] FIG. 5C shows a hollow cavity of a treatment component 551 of the applicator 350 of FIG. 5B with one or more protrusions 594a-594d (rcl'crrcd to collectively as “protrusions 594”) forming a flow path 595. In some embodiments, the treatment component 551 is hollow and includes an inlet opening 592a and an outlet opening 592b formed by the protrusions 594. The inlet opening 592a and the outlet opening 592b can be fluidically coupled an inlet passage and an outlet passage (e.g., the inlet passage 525 and the outlet passage 545 of FIG. 5B), respectively. The protrusions 594 can be configured to engage with and / or mate with one or more couplers. For example, the protrusions 594a and 594b are configured to engage with and / or mate with the couplers 590a and 590b, respectively, of FIG. 5B. The protrusions 594 can further extend from an inside edge 596 of the treatment component 551. For example, the protrusions 594c and 594d extend from the inside edge 596 to form the flow path 595, which can direct the temperature-controlled fluid from the inlet opening 592a along a serpentine path to the outlet opening 592b. In some embodiments, the height of the protrusions 594 is between 2 mm and 7 mm, any height therebetween, or at least 2 mm, 4.5 mm, or 7 mm. The average length of the protrusions 594 can be between 1.5 mm and 4 mm, any length therebetween, or at least 1.5 mm, 2.75 mm, or 4 mm, so as to fit within the applicator 350. In some embodiments, the average width of the flow path 595 is between 1 mm and 4 mm, any width therebetween, or at least 1 mm, 2.5 mm, or 4 mm. The flow path 595 can allow the temperature- controlled fluid to flow at a relatively constant rate within the treatment component 551 without generally large fluctuations in the pressure and / or flow rate, thereby minimizing the temperature variations on the distal face of the applicator (e.g., the distal face 557 of FIG. 5B) to provide uniform heat extraction from the target area. Doing so cools the target area to a predetermined depth, and therein reduces the likelihood of repeated thermal treatments.
[0062] FIG. 6 shows a ferrule coupling mechanism 600. The ferrule coupling mechanism 600 can include a ferrule 630, a tube 635, and a coupling member 655. In some embodiments, the coupling member 655 and ferrule 630 are include any features or functionality of the coupling member 355 and the ferrules 397 of FIG. 3D except that the coupling member 655 and ferrule 630 can be fluidically coupled to a singular tube 635 rather than both an inlet tube and an outlet tube (e.g., the inlet tube 325and outlet tube 345 of FIG. 3D). The ferrule coupling mechanism 600 can be fluidically coupled to the tube 635 and an applicator 650. In some embodiments, the coupling member 655 is pail of and / or contained within a component of the applicator 650. More specifically, the ferrule 630 can be an ovalized ring within the tube 635, and the tube 635 can then be pulled into the coupling member 655, which wedges the ferrule 630 and the tube 635 into place and creates a mechanical (i.e., adhesive less) attachment between the tube 635 and the applicator 650. In some embodiments, the applicator 650 is the applicator 350 of FIGS. 3A-3D and the inlet tube 325 and the outlet tube 345 are coupled to the applicator 350 using the ferrule coupling mechanism 600.
[0063] It can be advantageous to use the ferrule coupling mechanism 600 over coupling the components with adhesive because adhesive dispensing and curing can be variable. In addition, if the ferrule 630 and the base component of the applicator 650 (e.g., the base component 552 of the applicator 350 of FIG. 5B) 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. In some embodiments, the ferrule 630 is ovalized, meaning the ferrule 630 as well as the coupling member 655 can have an oval shape in which the cross-sectional dimension perpendicular to the applicator 650 can be minimized, as illustrated in more detail with reference to the ferrules 397 and the applicator 350 of FIG. 3D. This can minimize the overall profile, or envelope, of the applicator 650, and thus, improves the overall fit of the applicator 650 in the patient’s oral cavity.
[0064] FIG. 7 shows a base component 752 of a housing 710 including a flexible circuit 760 and onboard electronics 705. In some embodiments, the housing 710 and the flexible circuit 760 can include any features or functionality of the respective housing 310 and flexible circuit 360 described in more detail with reference to FIGS. 3B and 5A. As shown in FIG. 7, the onboard electronics 705 can be a circuit board coupled to the base component 752 by one or more couplers 707a and 707b (referred to collectively as “couplers 707”). Furthermore, the onboard electronics 705 can be electrically coupled to a cable 725 and the flexible circuit 760. A holder 715 coupled to the base component 752 with one or more fasteners 717a and 717b (referred to collectively as “fasteners 717”) can maintain the cable 725 on the base component 752. The holder 715 can be a small piece of metal or plastic used to secure the cable 725 in place within the housing 710. The holder 715 and thefasteners 717 can prevent the cable 725 from moving or becoming loose during insertion of a soft palate cryoprobe (e.g., the soft palate cryoprobe 300 of FIGS. 3A-3D).
[0065] In some embodiments, the flexible circuit 760 transmits measurements from the sensors on the face of an applicator during thermal treatment (e.g., the sensors 570 on the distal face 557 of the applicator 350 of FIGS. 5A and 5B) to the onboard electronics 705. The onboard electronics 705 can convert the 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 705 so that the cable 725 can send the analog signals to a controller (e.g., the controller 122 of FIGS. 1). Converting measurements locally at the onboard electronics 705 can reduce potential effects of electromagnetic interference on the analog measurements by integrating sensor and signal conversion functions into the flexible circuit 760 and the onboard electronics 705 instead of having these tasks performed elsewhere or remotely. Additionally or alternatively, the controller can change the flow rate of the temperature-controlled fluid flowing to the applicator based on the measurements from the sensors and the converted analog signal from the onboard electronics 705. For example, if a thermistor at the distal face of the applicator measures a resistance reading and the converted analog signal corresponds to a surface temperature generally too high to cause adipose cell death by adipose cryolysis at a depth of 1 cm (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 between 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.
[0066] In some embodiments, the flexible circuit 760 and the onboard electronics 705 are calibrated and optimized to function in the ranges of temperatures that are 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 760 and the onboard electronics 705 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), any frequency therebetween, or at least 0.5 Hz, 1.0 Hz, 1.5 Hz, 2.0 Hz, or 2.5 Hz. The user can test the flexible circuit 760 and the onboard electronics705 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 flexible circuit 760 and the onboard electronics 705 are customized to interpret and convert pressure, fluid flow, contact, and / or electrical impedance measurements into analog signals to monitor thermal treatment.1. FIG. 8 shows a fabric 800 shaped for an applicator. In some embodiments, the fabric 800 includes one or more cuts 805a-805f (referred to collectively as “cuts 805”) that create one or more edges 807a-807f (referred to collectively as “edges 807”) that allow the fabric 800 shaped to conform and / or complement a distal face of the applicator (e.g., the distal face 557 of the applicator 350 of FIG. 5A). The fabric 800 can be folded at the cuts 805 over an applicator, and the edges 807 created at the cuts 805 can fit between a treatment component and a base component of the applicator (e.g., the treatment component 551 and the base component 552 of the applicator 350 of FIG. 5B) such that the fabric 800 remains smooth on the distal face of the applicator. In some embodiments, the fabric 800 is made of a material suitable for contacting the soft palate and / or oropharyngeal area. Additionally or alternatively, the fabric 800 can be made of a material with high absorptive properties. For example, the fabric 800 is a polyester fabric (e.g., continuous filament knit polyester). In some embodiments, the fabric 800 is a foam (e.g., polyurethane foam), an adhesive layer configured to be coated in a cryoprotectant agent, and / or another material with high absorption properties. The fabric 800 can also come pre-soaked in cryoprotectant or the user can manually soak the fabric 800 in cryoprotectant before applying the fabric 800 to the applicator and / or to the target area to protect the target area from excess cooling damage. Additionally or alternatively, the distal face of the applicator can be covered with a cryoprotectant agent by, for example, an adhesive layer or surface treatment that affixes the cryoprotectant agent to the distal face without the use of fabric 800.
[0067] FIGS. 9 A and 9B show a treatment component 951 of an applicator with the fabric 800 of FIG. 8. As shown in FIG. 9A, the fabric 800 can cover a distal face 957 of the treatment component 951. In some embodiments, the fabric 800 is shaped to conform and / or complement the distal face 957 of the treatment component 951. In some embodiments, the treatment component 951 and the distal face 957 can include any features or functionality of the treatment component 551 and distal face 557 of the applicator 350 of FIG. 5B. As shown in FIG. 9B, the fabric 800 can wrap around aback face 955 of the treatment component 951. In some embodiments, the edges 807 tuck in between the treatment component 951 and the base component (e.g., the base component 552 of the applicator 350 of FIG. 5B) to maintain the fabric 800 on the distal face 957. It can be advantageous to tuck the edges 807 between the treatment component 951 and the base component of the applicator because the coupling mechanism between the two components, as described in more detail with reference to FIG. 5B, is typically mechanical and the user can couple and / or uncouple the two components another number of times, simplifying the assembly process relative to alternative methods.
[0068] FIG. 10 shows a handle 1005 with an axial support interface 1080. The handle 1005 can further include an inlet tube 1025, an outlet tube 1045, and a housing 1010. The housing 1010 can include a cover component 1065 and a base component 1060. The axial support interface 1080 can include a base 1085 and a stud 1087. As shown in FIG. 10, the base component 1060 can include a protruding platform 1075 that extends radially outward from the housing 1010. The base 1085 of the axial support interface 1080 can be coupled to the protruding platform 1075 such that the stud 1087 extends upwards from the protruding platform 1075. The base 1085 can be coupled to the axial support interface 1080 and the housing 1010, and the stud 1087 can be coupled to the housing 1010 and a positioning arm (e.g., the fixation arm 112 of FIG. 1). The positioning arm can hold the housing 1010 adjacent to a patient during treatment. In some embodiments, the axial support interface 1080 is designed to interface with an off-the-shelf equipment support system (e.g., FISSO articulated arm). Additionally or alternatively, the axial support interface 1080 can be coupled to the housing 1010 and a positioning arm adjacent to the patient during treatment. The handle 1005 can include any features or functionality of the housing 310 of the soft palate cryoprobe 300 of FIGS. 3A-3D except that the axial support interface 1080 can be perpendicular to the vertical axis of the handle 1005 on the protruding platform 1075. In some embodiments, the axial support interface 1080 is aligned with the housing 1010 along a common axis, which advantageously can help position the soft palate cryoprobe. For example, if the handle 1005 is attached to the fixation arm prior to inserting the soft palate cryoprobe into the oral cavity, having the axial support interface 1080 and the housing 1010 axially aligned makes it more intuitive for users to position and / or operate the device.
[0069] FIG. 11 shows a handle 1 105 with a radial support interface 1 180. The handle 1105 can further include an inlet tube 1125, an outlet tube 1145, and a housing 1110. The housing 1110 can include a cover component 1165 and a base component 1160. The radial support interface 1180 caninclude a base 1185 and a stud 1187. The handle 1105 can include any features or functionality of the handle 1005 of FIG. 10 except that the radial support interface 1180 can extend radially outward from the base component 1160. As shown in FIG. 11, the base 1185 of the radial support interface 1180 can be coupled to the base component 1160 such that the stud 1187 extends radially outwards from the base component 1160 and / or perpendicular to the axis along the length of the handle 1105. The handle 1105 can also include any features or functionality of the housing 310 of the soft palate cryoprobe 300 of FIGS. 3A-3D except that the inlet tube 1125 and the outlet tube 1145 can extend in a direction perpendicular to the axis along the length of the housing 1110. As further shown in FIG. 11, the inlet tube 1125 and the outlet tube 1145 can extend from the housing 1110 in a radial direction opposite the radial direction that the radial support interface 1180 extends in. In some embodiments, the radial support interface 1180 extends in a direction perpendicular to the housing 1110, which advantageously can help position the soft palate cryoprobe. For example, in cases where the handle 1105 is inserted into the oral cavity prior to attaching the radial support interface 1180 to the fixation arm (e.g., to improve maneuverability of the soft palate cryoprobe, and thus improve the user’s ability to position and / or reposition the applicator of the soft palate cryoprobe onto the soft palate), the radial support interface 1180 allows the user to move the fixation arm onto the housing 1110 without having to move the soft palate cryoprobe again. In doing so, the time spent repositioning the soft palate cryoprobe and the likelihood the cryoprobe contacts non-target areas is reduced.IV. Additional Components for Treatment of OSA
[0070] FIGS. 12A-12D show a conduit system 1200. Referring to FIGS. 12A and 12B together, the conduit system 1200 can include a conduit 1210 (e.g., a corrugated tube) with an inlet fluid channel 1225, an outlet fluid channel 1245, and one or more spacers 1230a- 1230h (collectively referred to as “spacers 1230”) within the conduit 1210. The conduit system 1200 can further include a support hook 1220 coupled to an external surface of the conduit 1210 and coupling members 1250a and 1250b (collectively referred to as “coupling members 1250”) coupled to end portions 1270a and 1270b (collectively referred to as “end portions 1270”) of the conduit 1210. In some embodiments, each of the coupling members 1250 mechanically clamps down onto the end portions 1270. The coupling members 1250 can fluidically couple the inlet fluid channel 1225 and the outlet fluid channel 1245 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 soft palate cryoprobe 300 of FIGS. 3A-3D) and / or a thermal treatment unit (e.g., thethermal treatment unit 106 of FIG. 1). More specifically, the coupling member 1250a can be coupled to the channel end portions 1225a, 1245a of the inlet fluid channel 1225 and the outlet fluid channel 1245, respectively. As such, the channel end portions 1225a, 1245a can fluidically couple the inlet fluid channel 1225 and the outlet fluid channel 1245 to the thermal treatment unit 106. In a similar manner, the coupling member 1250b can be couple to channel end portions 1225b, 1245b of the inlet fluid channel 1225 and the outlet fluid channel 1245, respectively. As such, the channel end portions 1225b, 1245b can fluidically couple the inlet fluid channel 1225 and the outlet fluid channel 1245 to the inlet tube 325 and the outlet tube 345 of the soft palate cryoprobe 300. In some embodiments, the conduit 1210 and the coupling members 1250 are the conduit 118 and the coupling members 120 of the sleep apnea treatment system 100 of FIG. 1. In some embodiments, the support hook 1220 couples the conduit 1210 to a positioning arm (e.g., the fixation arm 112 of FIG. 1). The support hook 1220 can position the conduit system 1200 in a preferred location between the positioning arm, the cryoprobe, and / or the patient.
[0071] FIG. 12C shows a view of the end portion 1270a of the conduit system 1200. As shown in FIG. 12C, the spacers 1230 can be generally shorter in length (e.g., between 2 cm and 10 cm or any length therebetween) and placed at linear intervals (e.g., between 5 cm and 25 cm apart or any interval therebetween). This spacing can allow the user to bend the conduit 1210 while maintaining the inlet fluid channel 1225 and the outlet fluid channel 1245 at an intermediate portion (e.g., center) of the conduit 1210. In some embodiments, the spacing interval between the spacers 1230 is selected to maintain flexibility and maximize thermal insulation of the conduit system 1200. For example, the shorter the interval between the spacers 1230, the less flexible the conduit system 1200 is, and the larger the interval between the spacers 1230, the more likely the inlet fluid channel 1225 and / or the outlet fluid channel 1245 contacts the conduit 1210 and / or kinks when the conduit 1210 is bent. Additionally or alternatively, if there is a larger interval between the spacers 1230, the air mass between the conduit 1210 and the inlet fluid channel 1225 and / or the outlet fluid channel 1245 can be decreased and / or eliminated, which in turn can decrease the insulative effect of the air gap between the conduit 1210 and the inlet fluid channel 1225 and / or the outlet fluid channel 1245 1215, as described in more detail with reference to FIG. 12D. 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 1200 can include the conduit 1210, the inletfluid channel 1225, the outlet fluid channel 1245, and the air. The coupling members 1250 can be at either end of the conduit 1210 to minimize air movement of the conduit system 1200. In some embodiments, the inlet fluid channel 1225 and the outlet fluid channel 1245 exit at the center of the distal portion of the coupling members 1250 and maintain a minimal gap between the fluid channels, as described in more detail with reference to FIG. 12D. Additionally or alternatively, the coupling members 1250 can be coupled to the inlet fluid channel 1225, the outlet fluid channel 1245, and a relief component, as described in more detail with reference to FIGS. 13A-13D.
[0072] FIG. 12D shows a top view of the conduit system 1200 looking directly down the conduit 1210. The inlet fluid channel 1225 and the outlet fluid channel 1245 run within and down the center of the conduit 1210 through a lumen 1235a in the spacer 1230a. Although not explicitly shown in FIGS. 12A-12D, a lumen generally similar to the lumen 1235a can be found on the spacers 1230b- 1230h. The lumen 1235a can be configured to keep the inlet fluid channel 1225 and the outlet fluid channel 1245 held at the intermediate portion of the conduit 1210 with minimal space therebetween. Positioning the inlet fluid channel 1225 and the outlet fluid channel 1245 at the intermediate portion of the conduit 1210 advantageously maximizes the amount of air between the inner surface of the conduit 1210 and the outer surface of the inlet fluid channel 1225 and the outlet fluid channel 1245. 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 1225 and the outlet fluid channel 1245 and the conduit 1210 can maximize the thermal insulation of the conduit system 1200. In addition, the conduit system 1200 can be advantageous to other potential insulating tubing constructions (e.g., a thicker silicone tube or open cell foam tube) because the conduit 1210 can be generally more flexible and lightweight. This provides the user with more control positioning the conduit 1210 throughout the surgical procedure.
[0073] In some embodiments, the conduit 1210 is a cormgated tube. Off-the-shelf cormgated 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 cormgated tubes can be more readily manufactured to include custom integration components (e.g., the coupling members 1250 and the spacers 1230).
[0074] In some embodiments, the conduit 1210 is made of a polymer and the spacers 1230 are made of a metal. One potential drawback of having metal spacers integrated into the walls of theconduit 1210 can be that bending the conduit 1210 can cause a rotation at the end portions 1270. Since the end portions 1270 can be coupled to the coupling members 1250, and the coupling members 1250 can be tightly fit to the inlet fluid channel 1225 and the outlet fluid channel 1245, the moment from the rotation of the conduit 1210 can transfer to the inlet fluid channel 1225 and the outlet fluid channel 1245. As such, if the inlet fluid channel 1225 and the outlet fluid channel 1245 are coupled to a soft palate cryoprobc, bending the conduit 1210 can cause a rotational moment to be transferred down the entirety of the soft palate cryoprobe. For example, the rotational moment can cause a soft palate cryoprobe positioned in a patient’s mouth to lose contact with the patient’s target area and thus lead to cold injury on non-target areas and / or longer procedure times.
[0075] In some embodiments, the rotation problem described above is overcome by integrating a rotational element into the coupling members 1250. FIGS. 13A-13D shows a coupling member 1350 with a relief component 1355. In some embodiments, the coupling member 1350 is one of the coupling members 1250 of the conduit system 1200 of FIGS. 12A-12D. FIG. 13A shows an isometric view of the coupling member 1350 coupled to a conduit 1310. The conduit 1310 can include any features or functionality of the conduit 1210 of FIGS. 12A-12D. The coupling member 1350 can include a cover component 1351, a base component 1352, and the relief component 1355. In some embodiments, the cover component 1351 is coupled to the base component 1352 such that the relief component 1355 can remain within the coupling member 1350. Stated differently, at least one of the cover component 1351 or the base component 1352 is rotatable relative to the relief component 1355, such that rotation of the cover component 1351 or base component 1352 is not translated to the relief component 1355. The cover component 1351 can be coupled to the base component 1352 using one or more coupling mechanisms including joints, screws, adhesive, and / or the like. The coupling member 1350 can further include an inlet fluid channel 1325 and an outlet fluid channel 1345. The inlet fluid channel 1325 and the outlet fluid channel 1345 can include any features or functionality of the inlet fluid channel 1225 and the outlet fluid channel 1245 of FIGS. 12A-12D.
[0076] FIG. 13B shows a cross sectional view of the coupling member 1350 of FIG. 13A. In some embodiments, the coupling member 1350 is configured to maintain an end portion 1370 of the conduit 1310. For example, the base component 1352 includes one or more protrusions 1390a- 1390c (collectively referred to as “protrusions 1390”) that maintain the end portion 1370 of the conduit 1310 within the coupling member 1350. The protrusions 1390 can be configured to engage with and / ormate with one or more ridges 1395a and 1395b (collectively referred to as “ridges 1395”) of the conduit 1310. The cover component (e.g., the cover component 1351 of FIG. 13A) can include identical or generally similar' protrusions to the protrusions 1390 included on the base component 1352. A rotational mate 1360 can be coupled to the relief component 1355 and to the coupling member 1350. The rotational mate 1360 and the relief component 1355 can include one or more openings configured to hold and / or secure the inlet fluid channel 1325 and the outlet fluid channel 1345 as the channels exit the coupling member 1350. The rotational mate 1360 can constrain the relief component 1355 along the XYZ axis such that the relief component 1355 can only rotate relative to coupling member halves (e.g., the cover component 1351 and / or the base component 1352) and not in a direction along the axis of the conduit 1310. Stated differently, the relief component 1355 can limit rotation within the coupling member 1350. Thereby, allowing the conduit 1310 to be twisted and / or bent without transferring the twist and / or bend to the inlet fluid channel 1325 and the outlet fluid channel 1345, as described in more detail with reference to FIGS. 13C and 13D.
[0077] In some embodiments, the relief component 1355 and the coupling member 1350 are constructed of lubricious materials (e.g., acetal or polyoxymethylene (POM), polytetrafluoroethylene (PTFE), and / or the like). In some embodiments, the rotational mate 1360 couples the relief component 1355 to the coupling member 1350 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 1355 and the coupling member 1350 to prevent interference. However, it can be advantageous to use the rotational mate 1360 over a lubricant in the interface since lubricant application has more inherit variability.
[0078] FIGS. 13C and 13D show the coupling member 1350 of FIG. 13A in various states. FIG. 13C shows the coupling member 1350 before a rotation 1380 in the counterclockwise direction. FIG. 13D shows the coupling member 1350 once that rotation has been complete. As shown in FIGS. 13C and 13D, the relief component 1355 can maintain the inlet fluid channel 1325 and the outlet fluid channel 1345 in relatively the same position before and after the rotation 1380. The relief component 1355 can be rotationally coupled to the coupling member 1350 such that the relief component 1355 can rotate relative to the coupling member 1350 freely. Thus, for some embodiments of the present technology, if the conduit 1310 or the coupling member 1350 is rotated, the rotation is not transferred to the relief component 1355 or the inlet fluid channel 1325 and the outlet fluid channel 1345.Furthermore for such embodiments, if the rotation is not transferred to the inlet fluid channel 1325 and the outlet fluid channel 1345, imparting the rotational moment to the cryoprobe (e.g., the soft palate cryoprobe 300 of FIGS. 3A-3D) can be reduced and / or eliminated.
[0079] FIG. 14 shows an insulator 1400 including an insulating pad 1450, an elongated body 1410, and a contact indicator 1420. In operation, the insulator 1400 in inserted on the backside of the soft palate during thermal treatment to provide an insulating layer between a soft palate cryoprobe (e.g., the soft palate cryoprobe of FIGS. 3A-3D) and the posterior pharyngeal wall. More specifically, the user can insert the insulating pad 1450 behind the soft palate before administering thermal treatment, as described in more detail with reference to FIGS. 18A-18D.
[0080] The elongated body 1410 can be coupled to the insulating pad 1450 and the contact indicator 1420. In some embodiments, the insulator 1400 can have a length (L2) that is between 30 cm and 50 cm, or any length therebetween. The length (L2) can be generally long enough so that when the contact indicator 1420 is on the patient’s chest, the insulating pad 1450 can contact the patient’s soft palate. The elongated body 1410 can further include a uvula cutout 1470 at a distal end 1415 of the elongated body 1410. The uvula cutout 1470 can allow the elongated body 1410 to “fork” at the interface between the elongated body 1410 and the insulating pad 1450. In some embodiments, the uvula cutout 1470 makes placement of the insulator 1400 on the back side of the soft palate easier. For example, without the uvula cutout 1470, the elongated body 1410 is more likely to fall to one side or the other of the uvula, which can then cause the insulating pad 1450 to be in a less than ideal position relative to the target area of the soft palate. This can result in cold injury to non-target areas. In an additional example, the uvula cutout 1470 is omitted, and the uvula presses onto the elongated body 1410, which in turn pushes the insulating pad 1450 into the caudal (e.g., towards the feet) direction. This can also lead to a less than ideal position of the insulating pad 1450 relative to the target area of the soft palate.
[0081] The uvula cutout 1470 can allow for more consistent and centered placement of the insulating pad 1450 from patient to patient. In some embodiments, the uvula cutout 1470 has a width of no more than 3 cm (e.g., 1 cm or 2 cm), so that the uvula cutout 1470 fits most uvulae of patients being treated. The size of the uvula cutout can be a width generally small enough to allow the elongated body 1410 to “fork,” but still generally wide enough that the elongated body 1410 does not break during placement and / or retrieval of the insulating pad 1450.
[0082] The contact indicator 1420 can include a pull tab 1425 and preinstalled electronics (e.g., the circuit 1630 of FIGS. 16A-16D). The user can pull the pull tab 1425 to activate the preinstalled electronics and provide electrical current to the insulator 1400, as described in more detail with reference to FIGS. 16A-16D. The insulating pad 1450 can include a tactile switch 1460 electrically coupled to the contact indicator 1420 by a flexible circuit 1465. The flexible circuit 1465 can extend along an entirety of the length of the elongated body 1410. In some embodiments, the elongated body 1410 houses the flexible circuit 1465 such that wiring from the contact indicator 1420 extend to the tactile switch 1460. The flexible circuit 1465 can deliver feedback from the tactile switch 1460 to the contact indicator 1420 such that the contact indicator 1420 can monitor contact of the soft palate cryoprobe probe (e.g., the soft palate cryoprobe 300 of FIGS. 3A-3D) at the soft palate. The contact indicator 1420 can reside outside the oral cavity and can indicate 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 1460, which is in contact with the posterior side of the soft palate, is engaged. Thus, the contact indicator 1420 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. In some embodiments, the contact indicator 1420 resides on a patient’s chest during thermal treatment, allowing the user to visualize alerts coming from the contact indicator 1420 as thermal treatment is administered. The insulating pad 1450 and the tactile switch 1460 are described in more detail with reference to FIGS. 15A and 15B. The contact indicator 1420 is described in more detail with reference to FIGS. 16A-16D.
[0083] FIGS. 15A and 15B show an insulating pad 1550. In some embodiments, the insulating pad 1550 can include any features or functionality of the insulating pad 1450 of the insulator 1400 of FIG. 14. As shown in FIG. 15A, the insulating pad 1550 can include a distal face 1557 that includes a tactile switch 1566 underneath a cover 1560. The insulating pad 1550 can further include legs 1570a and 1570b (referred to collectively as “legs 1570”) extending from a proximal end of the insulating pad 1550. The legs 1570 can be coupled to a uvula cutout (e.g., the uvula cutout 1470 of FIG. 14). The tactile switch 1566 can be at a proximal end of the distal face 1557. Additionally or alternatively, one or more of the tactile switches 1566 can be at the middle and / or distal ends of the distal face 1557. As described herein, when pressure exerted by the soft palate cry oprobe displaces the soft palate such that the cover 1560, and thus the tactile switch 1566, is in contact with the posterior side of the softpalate, a contact indicator (e.g., the contact indicator 1420 of FIG. 14) can indicate to the user that a pressure above a predetermined threshold has been applied by the soft palate cryoprobe (e.g., the soft palate cryoprobe 300 of FIGS. 3A-3D) to the soft palate. The number and placement of the one or more tactile switches 1566 can depend on the level of monitoring detail. The tactile switch 1566 can further be configured to detect a range of input pressures. For example, if it is important to maintain a precise level of contact on the soft palate by the soft palate probe the insulating pad 1550 can be configured with a precise level of contact by selecting a combination of operating conditions for the tactile switches 1566 and / or the surface area of the cover 1560 prior to treatment. For example, the tactile switch 1566 can detect a pressure on the soft palate between 10 mmHg and 80 mmHg or any pressure therebetween, or at least 10 mmHg, 30 mmHg, 50 mmHg, or 80 mmHg. It can be advantageous to configure the tactile switch 1566 and / or the surface area of the cover 1560 to a precise level of contact to ensure contact at the soft palate is sufficient to cool the soft palate to a predetermined depth, as described in more detail with reference to FIGS. 5A-5C and FIG. 7.
[0084] As shown in FIG. 15B, the insulating pad 1550 can include a back face 1552 that includes an edge 1530. The edge 1530 can be shaped to conform and / or complement to the pharyngeal wall and / or the posterior side of the of the soft palate. The edge 1530 can make the insulating pad 1550 generally less rigid, which in turn, can allow the insulating pad 1550 to slip into position on the posterior side of the soft palate. In some embodiments, the user places the insulating pad 1550 between the posterior side of the soft palate and the posterior wall in order to protect the posterior wall from damaging temperatures when thermally treating the soft palate. For example, in operation, the tactile switch 1566 indicates the pressure on the distal face 1557 of the insulating pad 1550 from the force used to place a soft palate cryoprobe on the soft palate. The user can monitor this force to ensure that the soft palate is fixated appropriately between the soft palate cryoprobe and the insulating pad 1550. In some embodiments, a console and / or a display is used to monitor the contact, as described in more detail with reference to FIG. 1. Additionally or alternatively, the insulating pad 1550 can be made of and / or comprise a non-conducting material (e.g., a soft foam) to protect nontarget regions of the oral cavity from thermal treatment.
[0085] FIGS. 16A-16D show a contact indicator 1620. In some embodiments, the contact indicator 1620 can include any features or functionality of the contact indicator 1420 of the insulator 1400 of FIG. 14. As shown in FIG. 16A, the contact indicator 1620 can include a body 1605 and apull tab 1625. The body 1605 can include a cover component 1651 and a base component 1652. The cover component 1651 can further include an LED 1680 that can monitor and visually alert the user about contact at the soft palate. The pull tab 1625 can be attached in a looped configuration such that the pull tab 1625 can be easy for the user to grasp and pull.
[0086] As shown in FIG. 16B, the contact indicator 1620 can include a circuit 1630 housed within the base component 1652 of the body 1605. The pull tab 1625 can be coupled the circuit 1630 such that when the user pulls the pull tab 1625, the circuit 1630 can power the contact indicator 1620. The base component 1652 can further include one or more couplers 1607a- 1607d (referred to collectively as “couplers 1607”). The couplers 1607 can be configured to engage with and / or mate with the cover component 1651 such that the contact indicator 1620 can encase the circuit 1630. In some embodiments, a foam covering (not illustrated) is on top of the circuit 1630 and compressed between the cover component 1651 and the base component 1652. The foam covering can protect the electrical components of the circuit 1630 from strain placed on the contact indicator 1620 (e.g., strain from positioning other instruments throughout thermal treatment). The pull tab 1625 can make the contact indicator intuitive to power, simplifying the number of surgical steps performed by the user, and thus, the length of the surgical procedure. It can further be advantageous to include the electrical components within the contact indicator 1620 to reduce the number of wires around the patient throughout treatment. For example, most pressure monitoring devices are coupled to an external power source via one or more wires, which can clutter the treatment area and make it more difficult for physicians to position instruments.
[0087] The circuit 1630 can have and transition between an inactive state and an active state. In the inactive state, the pull tab 1625 can remain in the contact indicator 1620. In the active state, the user can pull the pull tab 1625 from the contact indicator 1620 to complete the circuit 1630, which in turn, can power the contact indicator 1620. The circuit 1630 can also be electrically coupled to a tactile switch on an insulating pad (e.g., the tactile switch 1460 of the insulating pad 1450 of FIG. 14). In operation, the circuit 1630 can be in the active state and can transmit measurements collected by the tactile switch to the contact indicator 1620. The contact indicator 1620 can then provide visual feedback to the user via the LED 1680 based on the measurement, allowing the user to regulate the contact made to the soft palate throughout thermal treatment. In addition, the contact indicator can indicate the position of the soft palate cryoprobe on the soft palate. The user can use this informationto ensure the applicator makes sufficient contact with the soft palate such that the soft palate cryoprobe can cool the soft palate to a predetermined depth, shortening the overall procedure. Additionally or alternatively, the contact indicator 1620 can be designed as a membrane switch channel.
[0088] FIG. 16C shows a top view of the contact indicator 1620. As shown in FIG. 16C, the cover component 1651 can further include one or more tops 1617a-1617d (referred to collectively as “tops 1617”). FIG. 16D shows a back view of the contact indicator 1620. As shown in FIG. 16D, the back side of the base component 1652 can include the couplers 1607 of FIG. 16B. Referring now collectively to FIGS. 16C and 16D, the couplers 1607 can be configured to engage with and / or mate with the tops 1617 such that the contact indicator can encase the onboard electrical components. In some embodiments, the tops 1617 are openings and the couplers 1607 are pins configured to fit inside the openings using, for example, a press-pin mechanism, as described in more detail with reference to FIG. 4. Additionally or alternatively, one or more coupling mechanisms including joints, screws, adhesive, and / or the like can combine the cover component 1651 and the base component 1652. The cover component 1651 and the base component 1652 can be a polymer and / or another material suitable for contacting the skin and for housing electrical components. In some embodiments, the cover component 1651 and the base component 1652 are made of the same material. Additionally or alternatively, the cover component 1651 and the base component 1652 can be made of different materials.
[0089] FIG. 17 shows a kit 1700 for a sleep apnea treatment system. The kit 1700 can include a cryoprotectant agent 1720, a tongue cryoprobe 1730, a soft palate cryoprobe 1740 (e.g., the soft palate cryoprobe 300 of FIGS. 3A-3D), a conduit system 1750 (e.g., the conduit system 1200 ofFIGS. 12A-12D), and an insulator 1760 (e.g., the insulator 1400 of FIG. 14). The kit 1700 can come in a container 1770. In some embodiments, a container filler 1780 is on top of the components in the kit 1700 to protect the components during shipment. The container filler 1780 can be configured to fill the void between the components of the kit 1700 and the top of the container 1770. The container filler 1780 can be a foam insert, foam peanuts, and / or the like. In some embodiments, additional containers 1785a-1785e (referred to collectively as “additional containers 1785”) house and / or store the cryoprotectant agent 1720, the tongue cry oprobe 1730, and the soft palate cry oprobe 1740. The additional containers 1785 can be configured to fit within the container 1770. Moreover, theadditional containers 1785 can isolate the subcomponents of the cryoprotectant agent 1720, the tongue cryoprobe 1730, and the soft palate cryoprobe 1740, respectively. The container 1770 and the additional containers 1785 can be reusable or disposable boxes.
[0090] In some embodiments, the cryoprotectant agent 1720 come 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 1720 on an applicator of a cryoprobe and / or directly on the target area. In some embodiments, the kit 1700 further includes a spatula- like device (not illustrated) used to apply the cryoprotectant agent 1720. The cryoprotectant agent 1720 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.
[0091] The cryoprotectant agent 1720 can be designed with various properties in mind. For example, the cryoprotectant agent 1720 can be a 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 1720 is a biodegradable hydrogel scaffold. For example, the cryoprotectant agent 1720 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 1720 does not dissolve before thermal treatment is complete. Scaffolding components can be natural and biodegradable, synthetic and biodegradable, or synthetic and non- biodegradable. For example, natural and biodegradable scaffolding of a glycerol-gel 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 / orcarbapol. Depending on the polymers utilized, the glycerol-gel can have additional environmentally responsive features, such as temperature sensitivity, mucoadhesive qualities, etc. For example, the glycerol-gel includes a mucoadhesive polymer such as carboxymethylcellulose that can adhere to the surface of a target area.
[0092] The tongue cry oprobe 1730 can include one or more components configured to thermally treat a tongue. The tongue cryoprobe 1730 can include a handle and an applicator coupled to the handle. The handle can include an arm and one or more fluid lines. The arm can include a triggering mechanism which when triggered, can provide traction of the arm onto the tongue. The one or more fluid lines can include an inlet tube and an outlet tube positioned to direct temperature- controlled fluid to and from an active surface of the applicator. The applicator can be configured with a tapered front end to improve placement of the tongue cryoprobe at the tongue. The applicator can be further configured with a flexible circuit and one or more temperature sensors on a distal face to monitor the thermal treatment of the tongue. The conduit system 1750 can be fluidically coupled to the tongue cryoprobe 1730 and a temperature-controlled fluid source (e.g., the thermal treatment unit 106 of FIG. 1).
[0093] In some embodiments, the kit 1700 includes one or more additional components from the components discussed herein. Additionally or alternatively, the kit 1700 can be used with the sleep apnea treatment system 100 of FIGS. 1. One or more of the components of the kit 1700 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 1720, the tongue cryoprobe 1730, and the soft palate cryoprobe 1740, the conduit system 1750, and / or the insulator 1760, 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 1700 are disposable to prevent cross -contamination.V. Procedural Techniques for Treatment of OSA
[0094] FIGS. 18A-18D 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 100of FIG. 1). FIG. 18A illustrates a first method or stage of thermal treatment where the user can insert an insulator 1805 into the oral cavity to contact a posterior side of a soft palate (SP). The insulator 1805 can include any features or functionality of the insulator 1400 of FIG. 14. As shown in FIG. 18A, the insulator 1805 can include an insulating pad 1810 and a contact indicator 1815. The insulating pad 1810 and the contact indicator 1815 can include any features or functionality of the insulating pad 1550 of FIGS. 15A and 15B and the contact indicator 1620 of FIGS. 16A-16D, respectively.
[0095] 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 1805 into the oral cavity to provide protection to a posterior pharyngeal wall (PW) throughout thermal treatment. More specifically, the user can insert the insulator 1805 into the oral cavity such that the insulating pad 1810 contacts the posterior side of the soft palate. The contact indicator 1815 can indicate contact on the soft palate. For example, the LED of the contact indicator 1815 alerts the user if a threshold pressure is applied to the soft palate by a cryoprobe (e.g., the soft palate cryoprobe 1820 of FIG. 18B). The contact indicator 1815 can rest on the patient’s chest (not illustrated) throughout treatment, which can allow the physician to visualize alerts coming from the contact indicator 1815 as thermal treatment is administered to the soft palate. The contact indicator 1815, as described in more detail with reference to FIGS. 16A-16D, can monitor contact of the soft palate cryoprobc to monitor contact at the target area, and thereby the depth of cooling at the target area.
[0096] FIG. I8B illustrates a second method or stage of thermal treatment where the user can insert a soft palate cryoprobe 1820 into the oral cavity to thermally treat the soft palate (SP). The soft palate cryoprobe 1820 can include any of the details or functionality of the soft palate cryoprobe 300 of FIGS. 3A-3D or other cryoprobes described herein. The soft palate cryoprobe 1820 can include an applicator 1830 configured to thermally treat the soft palate (SP), and a support interface 1828. The support interface 1828 can be coupled to the soft palate cryoprobe 1820 and a fixation arm 1850, which can maintain the position of the soft palate cryoprobe 1820 throughout treatment. A coupling member 1855 can be fluidically coupled to the soft palate cryoprobe 1820 and a conduit 1860. The conduit 1860 can be fluidically coupled to a thermal treatment unit (e.g., the thermal treatment unit106 of FIG. 1) and the soft palate cryoprobe 1820 such that the thermal treatment unit can administer chilled / heated fluid to the soft palate cryoprobe 1820 to thermally treat the soft palate (SP). Additionally or alternatively, the soft palate cryoprobe 1820 can be electrically coupled to a controller (e.g., the controller 122 of FIG. 1) by an electrical cable 1825. 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 cry oprobe 1820.
[0097] In some embodiments, the user applies a cryoprotectant agent to the applicator 1830, the soft palate, and / or to the surrounding tissue at the target area before they insert the soft palate cryoprobe 1820 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 1820 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 1820. In some embodiments, the user inserts the soft palate cryoprobe 1820 into the oral cavity before the support interface 1828 is attached to the fixation arm 1850. More specifically, the user can insert the soft palate cryoprobe 1820 into the oral cavity and position and / or reposition the soft palate cryoprobe 1820 until the applicator 1830 makes sufficient contact with the soft palate (SP). Once the applicator 1830 is in contact with the soft palate (SP), the user can attach the soft palate cryoprobe 1820 to the fixation arm 1850. The fixation arm 1850 can maintain the position of the soft palate cryoprobe 1820, and thereby the applicator 1830 throughout thermal treatment. Additionally or alternatively, the user can attach the support interface 1828 of the soft palate cryoprobc 1820 to the fixation arm 1850 before inserting the soft palate cryoprobe 1820 into the oral cavity.
[0098] Once the soft palate cry oprobe 1820 is secured in place, the sleep apnea treatment system can circulate temperature-controlled fluid through the soft palate cryoprobe 1820 to the applicator 1830, cooling the soft palate (SP) for a predetermined time and temperature. For example, the temperature-controlled fluid circulates through the soft palate cryoprobe 1820 for approximately 30 minutes to bring and / or keep the applicator 1830 at a predetermined temperature (e.g., between - 30°C and 10°C). One or more sensors on the applicator 1830 (e.g., the sensors 570 of the applicator 350 if FIG. 5A) can monitor the temperature at the soft palate (SP) to determine or approximate the depth of cooling at the target area. After the duration of thermal treatment has ended, the sleep apnea treatment system can circulate heated fluid through the soft palate cryoprobc 1820, rewarming thesoft palate (SP) for a predetermined time and to a predetermined temperature to reduce 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 1820 from the fixation arm 1850 and can remove the soft palate cryoprobe 1820 from the oral cavity. In addition, the user can remove the insulator 1805 from the oral cavity, completing thermal treatment of the soft palate.
[0099] FIG. 18C 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 1870. The tongue cryoprobe 1870 can include any features or functionality of the tongue cryoprobe 1730 described in more detail with reference to FIG. 17. The tongue cryoprobe 1870 can include an applicator 1880, a support interface 1878, and working channels 1890. The applicator 1880 can be configured to thermally treat the tongue. The support interface 1878 can be coupled to the tongue cry oprobe 1870 and the fixation arm 1850 to maintain the position of the tongue cryoprobe 1870 throughout treatment. Similar to the operation of the soft palate cryoprobe 1820 described in more detail with reference to FIG. 18B, the coupling member 1855 can be fluidically coupled to the tongue cryoprobe 1870 and the conduit 1860, and the conduit 1860 can be fluidically coupled to the thermal treatment unit such that the conduit 1860 delivers the temperature-controlled fluid to the tongue cryoprobe 1870 to thermally treat the tongue. In a similar manner to the electrical cable 1825 of FIG. 18B, an electrical cable 1875 can be electrically coupled to the tongue cryoprobe 1870 and the controller to regulate the flow of temperature-controlled fluid to and from the tongue cryoprobc 1870 based on the conditions at the tongue.
[0100] In some embodiments, the user applies a cryoprotectant agent to the applicator 1880 or directly to the BoT, the epiglottis, and / or the vallecula before thermal treatment. The user can then insert the tongue cryoprobe 1870 into the oral cavity. More specifically, the physician can insert the tongue cryoprobe 1870 into the oral cavity and position and / or reposition the tongue cryoprobe 1870 until the applicator 1880 makes sufficient contact with the tongue. Once the applicator 1880 is in contact with the tongue, the user can attach the support interface 1878 to the fixation arm 1850 to maintain the position of the tongue cryoprobe 1870, and thereby the applicator 1880, throughout thermal treatment. In some embodiments, this method is advantageous since the user has more control positioning the applicator 1880 onto the tongue when the tongue cryoprobe is not attached to thesupport interface 1878. Additionally or alternatively, the user can attach the support interface 1878 to the fixation arm 1850 before inserting the tongue cryoprobe 1870 into the oral cavity. It can be advantageous to attach a cryoprobe to the fixation arm 1850 prior to inserting the cryoprobe into the oral cavity to align the cryoprobe with a preferred trajectory for thermal treatment.
[0101] FIG. 18D, shows a fourth method or stage of thermally treating the oropharyngeal area. As shown in FIG 18D, the user can insert one or more working instruments 1895 through the working channels 1890. The working channels 1890 can guide the working instruments 1895 to the area around the tongue. The working instruments 1895 can include suction tubes and / or endoscopes that aid in positioning the applicator 1880 onto the tongue. In some embodiments, the working instruments 1895 are used to monitor the tongue throughout thermal treatment.
[0102] After the tongue cryoprobe 1870 is positioned on the tongue, the conduit 1860 can deliver temperature-controlled fluid to the tongue cryoprobe 1870. The temperature-controlled fluid can circulate in the applicator 1880, extracting heat and cooling the tongue. In some embodiments, the temperature-controlled fluid circulates through the applicator 1880 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 1880 can include one or more sensors that can monitor the temperature at the tongue, as described in more detail with reference to FIG. 17. After cooling treatment ends, the sleep apnea treatment system can circulate heated fluid through the tongue cryoprobe 1870, rewarming the tongue for a predetermined time to a predetermined temperature. For example, the heated fluid circulates in the applicator 1880 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 rewanning phase has ended, the working instruments 1895 can be removed from the oral cavity. In addition, the tongue cryoprobe 1870 can be uncoupled from the fixation arm 1850 and removed from the oral cavity, completing thermal treatment of the tongue. It is worth noting that while methods or stages for thermally treating the 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.
[0103] FIGS. 19-22 show various visualization aids used to guide placement of cryoprobes prior to and during thermal treatment. As described in FIGS. 18A-18D, 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. 19-22, 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.
[0104] FIG. 19 illustrates a fluoroscopy-based visualization aid 1900, which can include a ring 1902 (e.g., a radiopaque ring) over a trachea tube 1904. The trachea tube 1904 can be inserted into the oral cavity such that the ring 1902 is positioned near an epiglottis (EP). Following the positioning of the fluoroscopy-based visualization aid 1900, a cryoprobe (e.g., the soft palate cryoprobe 1820 and / or the tongue cry oprobe 1870 of FIGS. 18A-18D) can be inserted into the mouth under the fluoroscopy guidance. In some embodiments, the fluoroscopy-based visualization aid 1900 is inserted into a working channel (e.g., the working channel 1890 of the tongue cryoprobe 1870 of FIG. 18D) 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.
[0105] FIG. 20 illustrates a fluoroscopy-based visualization aid 2000, which can include a radio opaque frame 2002, such as a steel wire. The radio opaque frame 2002 can be pre-bent and placed over a tongue (T) of the patient. In operation, the radio opaque frame 2002 can be positioned at the back of the oral cavity, assuring that the distal end of the radio opaque frame 2002 is at the vallecula (V). Following the positioning of the fluoroscopy-based visualization aid 2000, a cryoprobe (e.g., the soft palate cry oprobe 1820 and / or the tongue cry oprobe 1870 of FIGS . 18 A- 18D) can be inserted into the mouth under the fluoroscopy guidance.
[0106] FIG. 21 illustrates an optical visualization aid 2100, which can be an endoscope that the user advances either through the nasal passageway (NP) (as shown in FIG. 21) and / or through the oral cavity (OC). The optical visualization aid 2100 can guide the positioning of an applicator 2106 onto a tongue (T). In some embodiments, the optical visualization aid 2100 is a fiber optic wand that illuminates the applicator 2106 as the applicator is positioned on the tongue (T). In some embodiments, illuminating the applicator 2106 allows it to be recognized even when submerged undera pool of saliva and / or cryoprotectant fluid. In some embodiments, following the positioning of the optical visualization aid 2100, a cryoprobe (e.g., the soft palate cryoprobe 1820 and / or the tongue cryoprobe 1870 of FIGS. 18A-18D) is placed in the mouth under the visualization guidance. In some embodiments, the optical visualization aid 2100 is inserted into a working channel (e.g., the working channel 1890 of the tongue cryoprobe 1870 of FIG. 18D) 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 2100, as shown in FIG. 21, is positioned to visualize the applicator 2106 on the tongue (T), the optical visualization aid 2100 can be used to position an applicator on the soft palate.
[0107] FIG. 22 illustrates an ultrasound-based visualization aid 2200. The ultrasound-based visualization aid 2200 can include an ultrasound transducer placed underneath the chin, just before the crevice of the neck. The ultrasound-based visualization aid 2200 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 2200 is used to monitor the placement of the applicator 2206 on the target area and / or monitor an ice formation 2204 on the tongue (T) throughout thermal treatment. In some embodiments, the ultrasound-based visualization aid 2200 measures the thickness of the ice formation 2204. The distance from the ultrasound-based visualization aid 2200 to the applicator 2206, and the distance from the ultrasound-based visualization aid 2200 to the ice formation 2204 can be obtained / calculated, and used to obtain the ice thickness, which is a difference between the distance from ultrasound cryoprobc to applicator less the distance from ultrasound cryoprobc to ice formation. Monitoring the ice formation 2204 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 2200 as shown in FIG. 22 is positioned to visualize the applicator 2206 on the tongue (T), the ultrasound-based visualization aid 2200 can be positioned to visualize an applicator on the soft palate.
[0108] In some embodiments, the visualization aids described herein are used before the procedure. MRI imaging, ultrasound imaging, and / or electrical impedance tomography can provide useful 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 apatient’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
[0109] 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.
[0110] 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 “in response 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 pail on” or the phrase “based at least partially on.”
[0111] 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.
[0112] 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.
[0113] 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 are 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.
[0114] 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 claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment. Thus, the claims following this Detailed Description arc hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separateembodiment. This disclosure includes all permutations of the independent claims with their dependent claims.
[0115] 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 soft palate cryoprobe, comprising: a handle including- an elongated housing, an inlet tube extending through the elongated housing, and an outlet tube adjacent to the inlet tube and extending through the elongated housing; a coupling member coupled to a distal end portion of the handle; and an applicator coupled to the coupling member, such that the applicator is positioned at a fixed angle relative to a longitudinal axis defined by the handle, the applicator including- an inlet passage fluidically coupled to the inlet tube, an outlet passage fluidically coupled to the outlet tube, and a distal face configured to be in thermal contact with a soft palate of a patient.2. The soft palate cryoprobe of any one of the clauses herein, wherein the fixed angle is at most 15, 25, or 35 degrees.3. The soft palate cryoprobe of any one of the clauses herein, wherein the fixed angle is between 15 and 35 degrees.4. The soft palate cryoprobe of any one of the clauses herein, wherein the fixed angle is at most 35 degrees.5. The soft palate cryoprobe of any one of the clauses herein, wherein the inlet tube andthe outlet tube extend through at least a portion of the coupling member.6. The soft palate cry oprobe of any one of the clauses herein, wherein the inlet tube and the outlet tube are coupled to the coupling member by a ferrule coupling mechanism, the ferrule coupling mechanism including- a first ferrule within the inlet tube, and a second ferrule within the outlet tube, wherein the coupling member is coupled to the first ferrule within the inlet tube and the second ferrule within the outlet tube, such that, in operation, a fluid-tight seal is formed between the inlet tube, the outlet tube, and the coupling member.7. The soft palate cryoprobe of any one of the clauses herein, wherein the elongated housing has an ovular cross-sectional shape.8. The soft palate cryoprobe of any one of the clauses herein, wherein the handle includes a support interface extending from the elongated housing perpendicular’ to the longitudinal axis defined by the handle.9. The soft palate cryoprobe of any one of the clauses herein, wherein the elongated housing includes a cover component and a base component, and wherein the cover component is removably coupled to the base component such that the elongated housing encloses a length of the inlet tube and the outlet tube.10. The soft palate cryoprobe of any one of the clauses herein, wherein the elongated housing includes a cover component and a base component, and wherein the cover component is removably coupled to the base component using a press-pin mechanism, wherein- the cover component of the elongated housing includes one or more openings, and the base component of the elongated housing includes one or more couplers sized and shaped to fit inside the one or more openings.11. The soft palate cryoprobe of any one of the clauses herein, wherein the elongated housing has a first width and the applicator has a second width greater than the first width.12. The soft palate cryoprobe of any one of the clauses herein, wherein the elongated housing has a width of at most 1.9, 2.3, or 2.9 centimeters.13. The soft palate cryoprobe of any one of the clauses herein, wherein the elongated housing has a width between 1.9 and 2.9 centimeters.14. The soft palate cryoprobe of any one of the clauses herein, wherein the elongated housing has a width of at most 2.9 centimeters.15. The soft palate cryoprobe of any one of the clauses herein, wherein the applicator has a width of at least 3.8, 4.2, or 4.6 centimeters.16. The soft palate cryoprobe of any one of the clauses herein, wherein the applicator has a width between 3.8 and 4.6 centimeters.17. The soft palate cryoprobe of any one of the clauses herein, wherein the applicator has a width of at least 3.8 centimeters.18. The soft palate cryoprobe of any one of the clauses herein, wherein the elongated housing has a width of at most 2.9 centimeters, and the applicator has a width of at least 3.8 centimeters.19. The soft palate cryoprobe of any one of the clauses herein, wherein: the distal face includes an indented portion sized and shaped to receive a conductor; and the applicator further comprises a sensor embedded within the indented portion of the distal face, wherein the sensor is electrically coupled to the conductor.20. The soft palate cryoprobe of any one of the clauses herein, further comprising: a flexible circuit extending from the distal face of the applicator, across the coupling member, and to the elongated housing; and onboard electronics disposed within the elongated housing and electrically coupled to the flexible circuit.21. The soft palate cryoprobe of any one of the clauses herein, wherein the applicator includes a base component coupled to the coupling member and a treatment component removably coupled to the base component, and wherein the base component includes the inlet passage and the outlet passage.22. The soft palate cryoprobe of any one of the clauses herein, wherein (i) the inlet passage is configured to direct a temperature-controlled fluid from the inlet tube toward the distal face and (ii) the outlet passage is configured to direct the temperature-controlled fluid away from the distal face toward the outlet tube.23. An applicator for treatment of obstructive sleep apnea, the applicator comprising: a treatment component including- a hollow cavity having one or more protrusions that partially define a flow path, and a distal face thermally coupled to the hollow cavity, wherein, in operation, the distal face is in thermal contact with a soft palate of a patient; and a base component removably coupled to the treatment component, the base component including- an inlet passage fluidically coupled to the treatment component, an outlet passage adjacent to the inlet passage and fluidically coupled to the treatment component, a first coupler adjacent to the inlet passage, and a second coupler adjacent to the outlet passage, wherein the first coupler and the second coupler each engage with at least one of the one or more protrusions of the treatment component.24. The applicator of any one of the clauses herein, wherein the distal face is covered in a cryoprotectant agent.25. The applicator of any one of the clauses herein, wherein the distal face is covered in an adhesive layer or a surface treatment configured to affix a cryoprotectant agent to the distal face.26. The applicator of any one of the clauses herein, further comprising a fabric, a foam, and / or an adhesive layer positioned between the treatment component and the base component.27. The applicator of any one of the clauses herein, further comprising a fabric, a foam, and / or an adhesive layer positioned between the treatment component and the base component, wherein the fabric, the foam, and / or the adhesive layer is coated in a cryoprotectant agent.28. The applicator of any one of the clauses herein, wherein the treatment component comprises steel, aluminum, and / or nitinol and the base component comprises a rigid plastic and / or a polymer.29. The applicator of any one of the clauses herein, further comprising a conductor integrated into the distal face, and wherein the distal face includes an indented portion shaped and / or sized to receive the conductor.30. The applicator of any one of the clauses herein, further comprising one or more sensors integrated into the distal face, and wherein the one or more sensors are at least one of a temperature sensor, a pressure sensor, a contact sensor, or an electrical impedance sensor.31. The applicator of any one of the clauses herein, wherein the distal face has a long axis and a short axis normal to the long axis, and wherein a cross-surface dimension of the distal face at an intermediate portion of the long axis is at least 42, 43.5, or 45 millimeters.32. The applicator of any one of the clauses herein, wherein the distal face has a long axisand a short axis normal to the long axis, and wherein a cross-surface dimension of the distal face at an intermediate portion of the long axis is between 42 and 45 millimeters.33. The applicator of any one of the clauses herein, wherein the distal face has a long axis and a short axis normal to the long axis, and wherein a cross-surface dimension of the distal face at an intermediate portion of the long axis is at least 42 millimeters.34. The applicator of any one of the clauses herein, wherein the distal face has a long axis and a short axis normal to the long axis, and wherein a cross-surface dimension of the distal face at an intermediate portion of the short axis is at most 21, 22, or 23 millimeters.35. The applicator of any one of the clauses herein, wherein the distal face has a long axis and a short axis normal to the long axis, and wherein a cross-surface dimension of the distal face at an intermediate portion of the short axis is between 21 and 23 millimeters.36. The applicator of any one of the clauses herein, wherein the distal face has a long axis and a short axis normal to the long axis, and wherein a cross-surface dimension of the distal face at an intermediate portion of the short axis is at most 23 millimeters.37. The applicator of any one of the clauses herein, wherein the distal face has a long axis and a short axis normal to the long axis, wherein a first cross-surface dimension of the distal face at an intermediate portion of the long axis is at least 42 millimeters, and wherein a second cross-surface dimension of the distal face at an intermediate portion of the short axis is at most 23 millimeters.38. The applicator of any one of the clauses herein, wherein the distal face has a long axis and a short axis normal to the long axis, and wherein the distal face is curved along the long axis and the short axis.39. The applicator of any one of the clauses herein, wherein the distal face has a long axis and a short axis normal to the long axis, and wherein a cross-surface dimension of the distal face isgreatest at an intermediate portion of the long axis and is least at a peripheral portion of the long axis.40. The applicator of any one of the clauses herein, wherein (i) the inlet passage is configured to direct a temperature-controlled fluid to the hollow cavity and (ii) the outlet passage is configured to direct the temperature-controlled fluid away from the hollow cavity.41. The applicator of any one of the clauses herein, wherein the distal face is an active surface configured to be in direct contact with the soft palate.42. A device for treatment of obstructive sleep apnea, the device comprising: a handle including- an elongated housing, an inlet tube extending through the elongated housing, and an outlet tube adjacent to the inlet tube and extending through the elongated housing; a coupling member coupled to a distal end portion of the elongated housing; and an applicator removably coupled to the coupling member and including- a distal face having a long axis and a short axis normal to the long axis, a side surface extending proximally from the distal face towards the coupling member, a sensor positioned on the distal face, and a conductor electrically coupled to the sensor, wherein- the conductor extends from the sensor across the short axis of the applicator, along the side surface of the applicator and the coupling member, and to the elongated housing, and the distal face is configured to be in thermal contact with a soft palate of a patient.43. The device of any one of the clauses herein, wherein the distal face of the applicator includes an indented portion sized and shaped to receive the conductor, and wherein the sensor is embedded into the indented portion.44. The device of any one of the clauses herein, wherein the distal face of the applicator, the side surface of the applicator, and the coupling member include an indented portion shaped and / or sized to receive the conductor.45. The device of any one of the clauses herein, further comprising onboard electronics disposed within the elongated housing and electrically coupled to the conductor, wherein the conductor extends along an inner surface of the elongated housing to the onboard electronics.46. The device of any one of the clauses herein, wherein the sensor is a thermistor.47. The device of any one of the clauses herein, wherein the conductor is a flexible circuit.48. The device of any one of the clauses herein, wherein the distal face is curved along an entirety of the long axis and the short axis.49. The device of any one of the clauses herein, wherein the side surface includes an upper portion and a backside portion opposite the upper portion, wherein a height of the side surface of at least one of the upper portion or the backside portion is greatest at a center or intermediate area thereof.50. The device of any one of the clauses herein, wherein the side surface includes (i) an upper portion having a convex shape, (ii) a backside portion having a concave shape, and (iii) opposing side-end portions each extending from and between the upper portion and the backside portion.51. The device of any one of the clauses herein, wherein the side surface includes an upper portion having a convex shape and a backside portion having a concave shape.52. The device of any one of the clauses herein, wherein the long axis includes an intermediate portion and peripheral portions outward of the intermediate portion, and wherein adistalmost end the applicator is at the intermediate portion of the distal face.53. The device of any one of the clauses herein, wherein the long axis of the distal face includes an intermediate portion and peripheral portions outward of the intermediate portion, and wherein the peripheral portions are each proximal to the intermediate portion.54. The device of any one of the clauses herein, wherein the applicator includes a base component and a treatment component removably coupled to the base component, wherein the treatment component includes the distal face and the side surface.55. The device of any one of the clauses herein, wherein the applicator includes a base component and a treatment component removably coupled to the base component, wherein the base component includes a base surface facing distally toward the distal face of the treatment component, and a base member extending distally from the base surface, further comprising a ring disposed around the base member and / or in contact with the base surface.56. The device of any one of the clauses herein, wherein the applicator includes a base component and a treatment component removably 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.57. The device of any one of the clauses herein, wherein the side surface has a height at an intermediate portion of at most 8, 9, or 10 millimeters.58. The device of any one of the clauses herein, wherein the side surface has a height at an intermediate portion between 8 and 10 millimeters.59. The device of any one of the clauses herein, wherein the side surface has a height at an intermediate portion of at most 10 millimeters.60. The device of any one of the clauses herein, wherein the side surface has a height at a peripheral portion of at most 4, 5, or 6 millimeters.61. The device of any one of the clauses herein, wherein the side surface has a height at a peripheral portion between 4 and 6 millimeters.62. The device of any one of the clauses herein, wherein the side surface has a height at a peripheral portion of at most 6 millimeters.63. The device of any one of the clauses herein, wherein the side surface has a height at an intermediate portion of at most 10 millimeters and a height at a peripheral portion of at most 6 millimeters.64. 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; an insulator including- an elongated body, and an insulating pad coupled to a distal end portion of the elongated body; and a soft palate cryoprobe including- an inlet tube fluidically coupled to the conduit system, an outlet tube adjacent to the inlet tube and fluidically coupled to the conduit system, an elongated housing, wherein at least a portion of the inlet tube and at least a portion of the outlet tube are positioned within the elongated housing, and an applicator removably coupled to a distal end portion of the elongated housing and having a distal face, wherein, in operation, (i) the distal face is in thermal contact with a soft palate of a patient and (ii) the insulating pad provides thermal insulation to a posterior pharyngeal wall of the patient.65. The system of any one of the clauses herein, wherein the insulating pad includes a tactile switch and, wherein in operation, the tactile switch monitors a pressure threshold on the soft palate of at least 10 mmHg, 30 mmHg, 50 mmHg, or 80 mmHg.66. The system of any one of the clauses herein, wherein the insulating pad includes a tactile switch and, wherein in operation, the tactile switch monitors a pressure threshold on the soft palate between 10 mmHg and 80 mmHg.67. The system of any one of the clauses herein, wherein the insulating pad includes a tactile switch and, wherein in operation, the tactile switch monitors a pressure threshold on the soft palate of at least 10 mmHg.68. The system of any one of the clauses herein, wherein the insulator includes a contact indicator having an LED and electrically coupled to the insulating pad, wherein, in operation, the LED activates based on a measurement from the insulating pad.69. The system of any one of the clauses herein, wherein the insulator includes a contact indicator, and wherein the contact indicator has a pull tab and a circuit electrically coupled to the pull tab such that when the pull tab is pulled, the circuit electrically powers the contact indicator.70. The system of any one of the clauses herein, wherein the distal end portion of the elongated body includes a uvula cutout.71. 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 soft palate cryoprobe.72. The system of any one of the clauses herein, wherein the conduit system includes a conduit having 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 include a relief component configured to rotate relative to the conduit.73. The system of any one of the clauses herein, wherein the thermal treatment unit includes a temperature-controlled fluid, and wherein, in operation, (i) the inlet tube directs the temperature-controlled fluid from the conduit system to the applicator and (ii) the outlet tube directs the temperature-controlled fluid from the applicator to the conduit system.74. The system of any one of the clauses herein, further comprising a controller electrically coupled to the thermal treatment unit, wherein, in operation, the controller initiates thermal treatment of a temperature-controlled fluid.75. The system of any one of the clauses herein, further comprising electrically coupled to a conductor coupled to one or more sensors integrated into the distal face.76. The system of any one of the clauses herein, further comprising a controller, wherein, in operation, the controller causes the thermal treatment unit to direct a temperature-controlled fluid to the inlet tube based on a measurement from one or more sensors integrated into the distal face.77. The system of any one of the clauses herein, further comprising a controller electrically coupled to the thermal treatment unit, wherein, in operation, the controller initiates thermal treatment of a temperature-controlled fluid to a temperature between -40°C and -10°C.78. The system of any one of the clauses herein, further comprising a controller electrically coupled to the thermal treatment unit, wherein, in operation, the controller initiates theimal treatment of a temperature-controlled fluid to a temperature of at most -10°C.79. The system of any one of the clauses herein, wherein the thermal treatment unitincludes a heater and a chiller.80. The system of any one of the clauses herein, wherein the elongated housing includes a support interface configured to couple a fixation arm, wherein, in operation, the fixation arm positions the soft palate cryoprobe adjacent to the patient.
Claims
CLAIMSI / We claim:
1. A soft palate cryoprobe, comprising: a handle including- an elongated housing, an inlet tube extending through the elongated housing, and an outlet tube adjacent to the inlet tube and extending through the elongated housing; a coupling member coupled to a distal end portion of the handle; and an applicator coupled to the coupling member, such that the applicator is positioned at a fixed angle relative to a longitudinal axis defined by the handle, the applicator including- an inlet passage fluidically coupled to the inlet tube, an outlet passage fluidically coupled to the outlet tube, and a distal face configured to be in thermal contact with a soft palate of a patient.
2. The soft palate cryoprobe of claim 1, wherein the fixed angle is at most 35 degrees.
3. The soft palate cryoprobe of claim 1 , wherein the inlet tube and the outlet tube extend through at least a portion of the coupling member.
4. The soft palate cryoprobe of claim 1, wherein the inlet tube and the outlet tube are coupled to the coupling member by a ferrule coupling mechanism, the ferrule coupling mechanism including- a first ferrule within the inlet tube, and a second ferrule within the outlet tube, wherein the coupling member is coupled to the first ferrule within the inlet tube and the second ferrule within the outlet tube, such that, in operation, a fluid-tight seal is formed between the inlet tube, the outlet tube, and the coupling member.
5. The soft palate cryoprobe of claim 1, wherein the elongated housing has an ovular cross-sectional shape.
6. The soft palate cryoprobe of claim 1, wherein the elongated housing includes a cover component and a base component, and wherein the cover component is removably coupled to the base component using a press-pin mechanism, wherein- the cover component of the elongated housing includes one or more openings, and the base component of the elongated housing includes one or more couplers sized and shaped to fit inside the one or more openings.
7. The soft palate cry oprobe of claim 1, wherein the elongated housing has a first width and the applicator has a second width greater than the first width.
8. The soft palate cry oprobe of claim 1, wherein the elongated housing has a width of at most 2.9 centimeters, and the applicator has a width of at least 3.8 centimeters.
9. The soft palate cryoprobe of claim 1, wherein: the distal face includes an indented portion sized and shaped to receive a conductor; and the applicator further comprises a sensor embedded within the indented portion of the distal face, wherein the sensor is electrically coupled to the conductor.
10. The soft palate cryoprobe of claim 1, further comprising: a flexible circuit extending from the distal face of the applicator, across the coupling member, and to the elongated housing; and onboard electronics disposed within the elongated housing and electrically coupled to the flexible circuit.
11. An applicator for treatment of obstructive sleep apnea, the applicator comprising: a treatment component including- a hollow cavity having one or more protrusions that partially define a flow path, anda distal face thermally coupled to the hollow cavity, wherein, in operation, the distal face is in thermal contact with a soft palate of a patient; and a base component removably coupled to the treatment component, the base component including- an inlet passage fluidically coupled to the treatment component, an outlet passage adjacent to the inlet passage and fluidically coupled to the treatment component, a first coupler adjacent to the inlet passage, and a second coupler adjacent to the outlet passage, wherein the first coupler and the second coupler each engage with at least one of the one or more protrusions of the treatment component.
12. The applicator of claim 11, further comprising a fabric, a foam, and / or an adhesive layer positioned between the treatment component and the base component, wherein the fabric, the foam, and / or the adhesive layer is coated in a cryoprotectant agent.
13. The applicator of claim 11, wherein the treatment component comprises steel, aluminum, and / or nitinol and the base component comprises a rigid plastic and / or a polymer.
14. The applicator of claim 1 1 , further comprising one or more sensors integrated into the distal face, and wherein the one or more sensors are at least one of a temperature sensor, a pressure sensor, a contact sensor, or an electrical impedance sensor.
15. The applicator of claim 11, wherein the distal face has a long axis and a short axis normal to the long axis, wherein a first cross-surface dimension of the distal face at an intermediate portion of the long axis is at least 42 millimeters, and wherein a second cross-surface dimension of the distal face at an intermediate portion of the short axis is at most 23 millimeters.
16. A device for treatment of obstructive sleep apnea, the device comprising: a handle including-an elongated housing, an inlet tube extending through the elongated housing, and an outlet tube adjacent to the inlet tube and extending through the elongated housing; a coupling member coupled to a distal end portion of the elongated housing; and an applicator removably coupled to the coupling member and including- a distal face having a long axis and a short axis normal to the long axis, a side surface extending proximally from the distal face towards the coupling member, a sensor positioned on the distal face, and a conductor electrically coupled to the sensor, wherein- thc conductor extends from the sensor across the short axis of the applicator, along the side surface of the applicator and the coupling member, and to the elongated housing, and in operation, the distal face is in thermal contact with a soft palate of a patient.
17. The device of claim 16, wherein the distal face of the applicator includes an indented portion sized and shaped to receive the conductor, and wherein the sensor is embedded into the indented portion.
18. The device of claim 16, wherein the distal face of the applicator, the side surface of the applicator, and the coupling member include an indented portion shaped and / or sized to receive the conductor.
19. The device of claim 16, further comprising onboard electronics disposed within the elongated housing and electrically coupled to the conductor, wherein the conductor extends along an inner surface of the elongated housing to the onboard electronics.
20. The device of claim 16, wherein the sensor is a thermistor.
21. The device of claim 16, wherein the conductor is a flexible circuit.
22. The device of claim 16, wherein the distal face is curved along an entirety of the long axis and the short axis.
23. The device of claim 16, wherein the side surface includes an upper portion and a backside portion opposite the upper portion, wherein a height of the side surface of at least one of the upper portion or the backside portion is greatest at a center or intermediate area thereof.
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; an insulator including- an elongated body, and an insulating pad coupled to a distal end portion of the elongated body; and a soft palate cryoprobe including- an inlet tube fluidically coupled to the conduit system, an outlet tube adjacent to the inlet tube and fluidically coupled to the conduit system, an elongated housing, wherein at least a portion of the inlet tube and at least a portion of the outlet tube are positioned within the elongated housing, and an applicator removably coupled to a distal end portion of the elongated housing and having a distal face, wherein, in operation, (i) the distal face is in thermal contact with a soft palate of a patient and (ii) the insulating pad provides thermal insulation to a posterior pharyngeal wall of the patient.
25. The system of claim 24, wherein the insulating pad includes a tactile switch, and wherein, in operation, the tactile switch monitors a pressure threshold on the soft palate of at least 10 mmHg.
26. The system of claim 24, wherein the insulator includes a contact indicator having an LED and electrically coupled to the insulating pad, wherein, in operation, the LED activates based ona measurement from the insulating pad.
27. The system of claim 24, wherein the insulator includes a contact indicator, and wherein the contact indicator has a pull tab and a circuit electrically coupled to the pull tab such that when the pull tab is pulled, the circuit electrically powers the contact indicator.
28. The system of claim 24, wherein the distal end portion of the elongated body includes a uvula cutout.
29. 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 soft palate cryoprobe.
30. The system of claim 24, further comprising a controller electrically coupled to the thermal treatment unit, wherein, in operation, the controller initiates thermal treatment of a temperature-controlled fluid.
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