Cryogenic pressure stabilization

Abstract

A method for stabilizing pressure within a cryogenic device includes receiving a flow rate value corresponding to an expected average mass flow rate of coolant through a needle probe of the cryogenic device during a cryotherapy treatment cycle; determining a target heater power for the treatment cycle to be applied to a heater associated with the cryogenic device and configured to heat the coolant based on the flow rate value; receiving an input for the treatment cycle; flowing coolant toward the needle probe for a period of time in response to the input; and applying the target heater power to the heater during the treatment cycle to heat the coolant and stabilize the pressure within the cryogenic device.

Description

[Technical field]

[0001] (Cross-reference to related application data)

[0001] This application claims the benefit of U.S. Provisional Application No. 62 / 943,017, filed December 3, 2019, the entire disclosure of which is incorporated herein by reference in its entirety for all purposes.

[0002]

[0002] Devices, systems and methods for therapeutically cooling tissue, including nerves, to treat pain. [Background technology]

[0003]

[0003] The present disclosure relates generally to medical devices, systems and methods for cryotherapy. More particularly, the present disclosure relates to cryogenically cooling target tissue of a patient to denature, inhibit, change the structure, or otherwise affect the target tissue to obtain a desired change in its behavior or composition. Cryogenic cooling of nerve tissue has been found to be effective in treating a variety of indications, including pain (e.g., neuralgia in the occipital region and elsewhere, neuromas, osteoarthritis pain), spasms, and joint stiffness, among others. For example, cooling of nerve tissue has been found to denature or inhibit the nerves responsible for causing these symptoms. Cryogenic cooling has also been used to address cosmetic conditions, for example, by inhibiting undesirable and / or unsightly effects on the skin (e.g., lines, wrinkles, or cellulite depressions) or other surrounding tissues.

[0004] In view of the above, cryogenic devices with needle probes have emerged as a method of therapeutically cooling target tissue to treat various indications. The needle probe of such devices is typically inserted into the patient's skin adjacent to the target tissue. Some cryogenic devices include a coolant that can either be inserted into the target tissue through the needle opening of the device's needle probe, so that the target tissue is directly cooled by the coolant. Other cryogenic probes may include a closed needle tip. In this case, the needle is cooled (e.g., by a flow of coolant) and the target tissue adjacent to the cooled needle may thus be cooled by conduction. Cryogenic probes have proven to be precise, simple, reliable, and effective in creating a cryogenic zone within the patient at or around the target tissue. The cryogenic zone may be a volume of tissue that is cooled by one or more needles of the cryogenic probe (e.g., a volume of tissue near or around the distal portion of the needle). For example, a cryogenic zone may be a volume of tissue that is cooled to freeze the tissue within the volume (e.g., a cryogenic zone that may form around the needle of a cryogenic probe may be defined by an isotherm at about 0° C. (or other suitable temperature)). Summary of the Invention

[0005] FIELD OF THE DISCLOSURE

[0005] This disclosure relates to improved medical devices, systems and methods. Many of the devices and systems described herein are useful for cryotherapy using cryogenic devices.

[0006]

[0006] In some embodiments, the method may include receiving a first flow rate value, the first flow rate value corresponding to an expected average mass flow rate of coolant through a first needle probe of the cryostat during a cryotherapy treatment cycle. The method may further include determining a first target heater power to be applied to a heater associated with the cryostat for the first treatment cycle based on the first flow rate value. The method may further include receiving an input for the first treatment cycle. The method may include directing coolant to the first needle probe for a period of time in response to the input, and applying the first target heater power during the first treatment cycle to heat the coolant and stabilize pressure within the cryostat during or after the first treatment cycle (or before the first treatment cycle in some embodiments). Such a method may be used, for example, to stabilize pressure within the cryostat during a cryotherapy treatment.

[0007] In some embodiments, the first target heater power is defined such that an average rate of change of pressure during a cooling phase of the first treatment cycle remains within a predetermined range. In some embodiments, the first flow rate value is received at a processor of the cryogenic device from the first needle probe.

[0008] In some embodiments, the heater is coupled to a coolant cartridge associated with the cryogenic device. In some embodiments, the cryogenic device includes a handpiece portion, and the coolant cartridge and the first needle probe may be directly coupled to the handpiece portion.

[0009] In some embodiments, the method may include determining a target duty cycle (or pulse width modulation percentage (PWM%)) required to apply the first target heater power. In these embodiments, applying the first target heater power may include activating the heater for the target duty cycle. In some embodiments, the target duty cycle is determined by the equation: Duty Cycle=PWM%.標的 ×(R ヒータ / V ヒータ 2 ) output. In this equation, P 標的 is the first target heater power, R ヒータ is the resistance of the heater, and V ヒータ is the heater voltage. In some embodiments, the method ヒータ The method includes monitoring a voltage of a power supply coupled to the heater to estimate a real-time value of

[0010] In some embodiments, applying the first target heater power includes adjusting the amount of current or voltage applied to the heater.

[0011] In some embodiments, the method includes receiving pressure data from a pressure sensor of the cryogenic device during a first treatment cycle, calculating an average rate of change of pressure during a cooling phase of the first treatment cycle based on the received pressure data, and calculating a second target heater power for a second treatment cycle, the second target heater power being calculated at least in part by adjusting the first target heater power upward or downward by an adjustment value based on the average rate of change of pressure. In some embodiments, the method may include determining that the average rate of change of pressure is negative and exceeds a predetermined range, and the second target heater power being calculated at least in part by adjusting the first target heater power upward by the adjustment value. In some embodiments, the method may include determining that the average rate of change of pressure is positive and exceeds a predetermined range, and the second target heater power being calculated at least in part by adjusting the first target heater power downward by the adjustment value. In some embodiments, the adjustment value is determined based on a magnitude of the average rate of change of pressure.

[0012] In some embodiments, the method may include determining that the average rate of change of pressure is greater than a threshold magnitude. The method may further include generating a notification based on the determination, indicating a problem with the cryogenic device. In some embodiments, the average rate of change of pressure may be determined to be negative, and the notification may identify the problem as a reduction in the coolant source based on the average rate of change of pressure. In some embodiments, the average rate of change of pressure may be determined to be positive, and the notification may identify the problem as a blockage or obstruction in the coolant path based on the average rate of change of pressure.

[0013] In some embodiments, the method may include determining a first pressure of the cryostat prior to a cooling cycle of a first treatment cycle, determining a second pressure of the cryostat prior to a cooling cycle of a second treatment cycle, and calculating a second target heater power for the second treatment cycle. In some embodiments, the second target heater power is calculated at least in part by adjusting the first target heater power upward if the second pressure is less than the first pressure, or by adjusting the first target heater power downward if the second pressure is greater than the first pressure.

[0014]

[0014] In some embodiments, the method may include replacing the first needle probe with a second needle probe, receiving a second flow rate value corresponding to an expected average mass flow rate of coolant through the second needle probe during a cryotherapy treatment cycle, and determining a new target heater power to be applied by the heater for the treatment cycle performed with the second needle probe based on the second flow rate value.

[0015] In some embodiments, the first treatment cycle includes a cooling phase and a recovery phase, hi some embodiments, the first targeted heater power is applied during the cooling phase.

[0016]

[0016] A cryogenic device is described for carrying out the methods described herein. In some embodiments, the cryogenic device may include a coolant source including pressurized coolant, a coolant pathway configured to direct the coolant toward a needle probe including one or more needles, the coolant configured to deliver cryotherapy to a target tissue via the one or more needles, a heater, and a processor. In some embodiments, the processor is configured to receive a first flow rate value corresponding to an expected average mass flow rate of the coolant through a first needle probe of the cryogenic device during a cryotherapy treatment cycle, determine a first target heater power for the first treatment cycle to be applied to a heater associated with the cryogenic device and configured to heat the coolant based on the first flow rate value, receive an input for the first treatment cycle, and in response to the input, apply the first target heater power to the heater during the first treatment cycle to direct the first needle probe to cause the coolant to flow for a period of time, heat the coolant, and stabilize a pressure within the cryogenic device during or after the first treatment cycle. [Brief description of the drawings]

[0017] [Figure 1A] 1 illustrates an exemplary embodiment of a cryogenic device including a cartridge holder for holding a coolant cartridge and a needle probe. [Figure 1B] 1 illustrates an exemplary embodiment of a cryogenic device including a cartridge holder for holding a coolant cartridge and a needle probe. [Figure 2A] 1 illustrates an exemplary needle probe. [Figure 2B] 1 illustrates an exemplary embodiment of a port in the PCBA of the handpiece portion that receives a proximal portion of the PCBA of the needle probe. [Figure 2C] 1 illustrates an exemplary embodiment of a port in the PCBA of the handpiece portion that receives a proximal portion of the PCBA of the needle probe. [Figure 3A]An exemplary graph reflecting the pressures and temperatures associated with a cryogenic device during a single treatment cycle is shown, where a heater heats the outside of the coolant cartridge to maintain a relatively constant temperature outside of the coolant cartridge. [Figure 3B] 3B shows an exemplary graph reflecting the pressure and temperature inside the cryogenic device during a treatment cycle, resulting from the treatment cycle shown in FIG. 3A. [Figure 4] 1 shows a simplified cross-sectional schematic diagram of an exemplary coolant cartridge coupled to a needle probe via a coolant pathway. [Diagram 5] 1 illustrates an exemplary high level diagram of a cryogenic system. [Figure 6] 1 shows an exemplary pressure / temperature graph corresponding to a method for stabilizing coolant pressure by applying targeted heater power specifically designed to offset the amount of pressure loss during the cooling phase of a treatment cycle. [Figure 7] 1 shows an exemplary pressure / temperature graph corresponding to a method of real-time pressure monitoring and correction to stabilize pressure during the cooling phase. [Figure 8] 13 shows exemplary pressure / temperature graphs of multiple treatment cycles, including a treatment cycle that indicates a cryogenic device problem. [Figure 9] 1 shows a simplified schematic of a cryogenic apparatus in use. [Figure 10] 1 illustrates an exemplary method for stabilizing pressure within a cryogenic device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018]

[0029] This disclosure describes features of cryodevices that can be used to deliver cryotherapy to a patient. In some embodiments, the described cryodevices include needles for delivering cryotherapy subcutaneously and can target specific tissues to treat various conditions. For example, the cryodevices can include needles configured to be inserted near peripheral nerves to deliver cryotherapy to the peripheral nerves to treat pain, spasms, or other such conditions that would be improved by this treatment. Further information on the use of cryotherapy for pain or spasm relief can be found in U.S. Patent No. 8,298,216, filed November 14, 2008; U.S. Patent No. 9,610,112, filed March 18, 2014; U.S. Patent No. 10,085,789, filed March 13, 2017; and U.S. Patent Application Publication No. 20190038459, filed September 14, 2018, the entire disclosures of which are incorporated herein by reference in their entirety for all purposes. Cryogenic devices may also be used for prophylactic treatments, such as destruction or prevention of neuromas, as described, for example, in U.S. Pat. No. 10,470,813, filed March 14, 2016, the entire disclosure of which is incorporated herein by reference in its entirety for all purposes.

[0019]

[0030] 1A-1B show an exemplary embodiment of a cryogenic device 100 including a coolant cartridge 130 and a cartridge holder 140 for holding a needle probe 110. As shown in the illustrated exemplary embodiment, the cryogenic device 100 may be a self-contained handpiece suitable for being held and manipulated by an operator's hand. In other embodiments, the cryogenic device may include physically separated components. For example, the cryogenic device may include a handpiece including a needle probe and a coolant cartridge that is separate from the handpiece. In some embodiments, the cryogenic device 100 may have a multi-part (e.g., two-part) housing with the needle probe 110 disposed within a separate probe housing that may be coupled to the housing of the handpiece portion. In other embodiments, the needle probe 110 may not be disposed within a separate housing and may be configured to be inserted directly into the housing of the cryogenic device 100. By way of example, the cryogenic device 100 of at least some of these embodiments may have a single housing.

[0020]

[0031] In some embodiments, the coolant cartridge 130 can be a disposable cartridge filled with a coolant (e.g., nitrous oxide, a fluorocarbon refrigerant, and / or carbon dioxide). The coolant cartridge 130 can be pressurized such that the coolant therein is maintained at a relatively high pressure. In some embodiments, the cryogenic device 100 can include a cartridge door 120 for accessing the coolant cartridge 130 (e.g., for replacing the cartridge). The cartridge door 120 can be configured to move from an open position to allow the cartridge holder 140 to receive the coolant cartridge 130 to a closed position to secure the coolant cartridge 130 within the housing of the cryogenic device 100. For example, as shown in FIGS. 1A-1B, the cartridge door 120 can be configured to pivot about a pivot point 125 to provide access to the coolant cartridge 130. In this example, a user can open the cartridge door 120 as shown in FIG. 1A (e.g., if the user realizes that the coolant cartridge 130 is empty), remove the coolant cartridge 130 from the cartridge holder 140, insert a new coolant cartridge 130 into the cartridge holder 140, and close the cartridge door 120 as shown in FIG. 1B.

[0021]

[0032] In some embodiments, cryotherapy using the cryostat 100 may be performed in separate treatment cycles. For example, the processor of the cryostat 100 may be configured to control coolant flow (e.g., by operating a supply valve). The processor may be configured to provide a treatment cycle in response to a treatment instruction. A treatment cycle may include a cooling phase (where coolant flows to the needle) and a recovery phase (where coolant does not flow to the needle). For example, a treatment cycle may include a cooling phase duration of 20-65 seconds, followed by a recovery phase duration of 10-60 seconds. As another example, it may be particularly advantageous for a treatment cycle to include a cooling phase duration of 33-60 seconds, followed by a recovery phase duration of 15-45 seconds. During the cooling phase, as coolant flows to the needle, a cryogenic zone may be formed in the tissue around the needle (e.g., at the distal end of the needle). The cryogenic zone may be defined by an isotherm (e.g., a cooling zone), for example, at 0° C., to include a frozen "ice ball" of tissue. In some embodiments, the coolant can be vaporized inside the needle lumen (by enhancing the Joule-Thomson effect) to create a cryogenic zone. During the recovery phase, the coolant flow is stopped to allow the needle to warm up to the baseline temperature. Further information regarding the treatment cycle can be found in U.S. Patent Application Publication No. 20190038459, filed September 14, 2018, which is incorporated by reference in its entirety for all purposes.

[0022]

[0033] In some embodiments, the cryogenic device 100 includes a skin warmer, which may be a heating element, for example, to warm the skin to reduce collateral damage to the skin. The skin warmer may be activated before or during a treatment cycle for a predetermined heating duration. For example, the skin warmer may be activated for a pre-heating period of a particular duration before a treatment cycle. More information about cryogenic devices with skin warmers can be found in U.S. Patent No. 10,470,813, filed March 14, 2016, which is incorporated by reference in its entirety for all purposes.

[0023]

[0034] FIG. 2A illustrates an exemplary needle probe 110. In some embodiments, the illustrated needle probe 110 may have an external housing (not shown). In some embodiments, the needle probe 110 may include one or more needles 115 adapted to pierce the patient's skin adjacent to the target tissue (e.g., neural tissue). For example, as shown in FIG. 2A, the needle probe 110 may include three needles 115. Each of the needles of the needle probe 110 may have a needle lumen disposed therein (not shown). In some embodiments, the needles 115 may have a closed tip without any distal opening. This prevents the exit of coolant from the distal end of the needles 115. In these embodiments, the needles 115 themselves are cooled, which cools the adjacent target tissue by conduction. For example, the needles may have a needle lumen through which coolant flows, thereby cooling the needles. In other embodiments, the needles 115 may have an open tip. In this case, the target tissue is cooled by injecting a coolant into or adjacent the target tissue into the patient. In some embodiments, the needle probe 110 may include a probe extension 119 configured to be secured to the probe receptacle 170. When the needle probe is secured to the probe receptacle 170, the probe extension 119 extends proximally toward the proximal end of the cryostat (for illustration purposes, the proximal and distal directions are indicated in FIG. 1A). With reference to FIG. 2A, the probe extension 119 may have a probe lumen disposed therein (not shown), which extends from the proximal end to the distal end. When the needle probe is secured to the probe receptacle, the probe lumen may be fluidly coupled to a coolant pathway extending from the coolant cartridge 130 toward the probe receptacle 170 to deliver coolant to the needle. The probe lumen can be coupled to the needle lumen of the needle 115 at the distal end of the cryogenic device such that coolant can be allowed to pass through the probe lumen and into the needle lumen (e.g., to cool the needle tip). In some embodiments, the coolant can be exhausted (e.g., proximally) after cooling the needle.In some embodiments, coolant may be continuously and sequentially flowed into and out of the needle lumen (eg, during one or more treatment cycles).

[0024]

[0035] In some embodiments, the cryogenic device 100 may be a smart device including a first processor (e.g., located within the handpiece and away from the needle probe 110) to assist an operator performing a procedure. In some embodiments, the needle probe 110 may be a smart probe. In these embodiments, the needle probe 110 may include a printed circuit board assembly (PCBA). As shown in FIG. 2A, the PCBA may include a second processor 118a. In some embodiments, the PCBA may also include memory components. The PCBA may further include one or more connectors 118b (e.g., card edge connectors) that electrically couple the needle probe 110 to the remainder of the cryogenic device 100 (e.g., the handpiece portion). For example, when the needle probe is received by the probe receptacle 170, a portion of the PCBA 118 (including the connector 118b) may be received in a port of the handpiece portion.

[0025]

[0036] 2B-2C show an exemplary embodiment of a port 178 of a PCBA 175 of the hand piece portion that receives a proximal portion of a PCBA 118 of a needle probe 110. As shown in the exemplary embodiment of FIGS. 2B-2C, a connector 118b of the PCBA 118 can be configured to slide into an opening of the port 178 of the PCBA 175 of the hand piece portion.

[0026]

[0037] When the PCBA 118 of the needle probe 110 is connected to the PCBA 175 of the hand piece portion, the needle probe 110 may be able to send and / or receive information to and from the hand piece portion (e.g., via the second processor 118a). In some embodiments, the needle probe 110 may send (e.g., to the first processor) a probe descriptor that may, among other things, identify the corresponding probe type of the needle probe. For example, the probe descriptor may specify the number of needles (e.g., single needle probe, three needle probe, five needle probe), the length of the needles, the configuration of the needles (e.g., a rectangular array, a square array, a three-dimensional shape such as an oval, a circle, a triangle, an inverted pyramid shape, etc.), the average mass flow rate of coolant through the needle probe, the preheat duration during which the skin warmer of the cryostat 100 is activated, the duration of the cooling phase during which coolant is delivered to the needle probe 110, the duration of the recovery phase during which a valve is shut off to prevent further delivery of coolant to the needle probe 110, or any other suitable feature or parameter that may be specified for the operation of the needle probe 110. Probe descriptors and the specific types of parameters that may be included therein are further described below. More information on smart cryostats and smart chips may be found in U.S. Patent No. 10,130,409, filed November 20, 2018, which is incorporated by reference in its entirety for all purposes.

[0027]

[0038] FIG. 3A shows an exemplary pressure / temperature curve reflecting the pressure and temperature associated with the cryogenic device 100 during a single treatment cycle, where a heater heats the exterior of the coolant cartridge 130 to maintain a relatively constant temperature outside the coolant cartridge 130. With reference to FIG. 3A, a treatment cycle can begin with a cooling phase 310, followed by a recovery phase 320. The line labeled TProbe in FIG. 3A refers to the temperature at the needle probe 110. The line labeled Pressure refers to the pressure of the coolant inside the cryogenic device 100. This pressure may be measured, for example, by one or more pressure sensors upstream or downstream of the supply valve through which the coolant flows. The line labeled TCrtg(Ext) shows the temperature outside the coolant cartridge 130, as may be measured, for example, by one or more temperature sensors positioned near or adjacent to the coolant cartridge 130. As shown, the temperature of the needle probe 110 is forced to decrease during the cooling phase 310 as an increasing amount of coolant flows into the lumen of the needle probe 110. In FIG. 3A (and subsequent figures showing temperature / pressure curves within this disclosure), the TProbe and TCrtg(Ext) lines should be read with reference to the “Temperature (° C.)” axis, and the Pressure line should be read with reference to the “Pressure (psia)” axis. In some embodiments, the coolant inside the coolant cartridge 130 can be pressurized to be at a reference pressure value. For example, as shown in FIG. 3A, the reference pressure value can be about 910 pounds per square inch absolute (psia). As the coolant is released from the pressurized coolant cartridge 130 during the cooling phase 310 and is channeled along the coolant path, the reduction in the coolant inside the coolant cartridge 130 can cause the pressure inside the coolant cartridge 130 to decrease relative to the reference pressure. Additionally, this pressure decrease can also be accompanied by a temperature decrease. This temperature drop can be due to a phase change of the coolant that occurs. The coolant can be pressurized inside the coolant cartridge 130 to maintain a near liquid phase.As coolant is released from the coolant cartridge 130 and the pressure drops as a result, a certain amount of the liquid coolant may undergo a phase change from liquid to gas (e.g., liquid N2O boils and vaporizes to gaseous N2O due to the drop in pressure). This is an endothermic phase change that extracts heat from the surroundings and ultimately cools the remaining liquid coolant. The drop in pressure during the treatment cycle is shown in the example of FIG. 3A by the Pressure line. As shown by bracket 312-1 in FIG. 3A, when the cooling phase 310 of the treatment cycle begins, the pressure initially drops by about 10 psia as coolant is released from the coolant cartridge 130 (e.g., when the supply valve is opened). In the example shown in FIG. 3A, the pressure continues to drop during the remainder of the cooling phase, dropping by about 20 psia. This continued drop in pressure is shown by bracket 312-2. This results in a total pressure drop of about 30 psia (10 psia + 20 psia).

[0028]

[0039] The pressure of the coolant in the coolant cartridge 130 can be important in that the pressure of the coolant affects the flow rate of the coolant to the needle probe 110. A significant pressure drop can result in a reduction in the amount of coolant delivered to the needle of the needle probe 110 and / or the amount of coolant vaporized inside the needle of the needle probe 110 during a treatment cycle, ultimately affecting the characteristics of the cryogenic zone due to the resulting cooling. A pressure drop can result in the formation of a cryogenic zone that is smaller than optimal volume, for example.

[0029]

[0040] In some embodiments, the cryogenic device 100 can actively increase the temperature of the coolant inside the cryogenic cartridge 130 to increase the pressure of the coolant, thereby compensating for some of the reduction in pressure. In some embodiments, the cryogenic device 100 can include a heater to actively increase the temperature of the coolant. Increasing the temperature of the coolant increases the pressure of the coolant. The exact amount of pressure increase is based on the specific properties of the coolant, which may be characterized by its respective liquid-gas phase transition curve (e.g., for N2O, by the well-known liquid-gas phase transition curve of N2O). For example, as described below, one or more heaters can be positioned along the exterior of the cryogenic device 100 to apply heat to the coolant cartridge 130. FIG. 3A illustrates one approach to increasing pressure by applying a relatively small amount of heat to the cryogenic device 100 to maintain the exterior of the cryogenic device 100 at a relatively constant temperature over the entire life of the cryogenic device 100 (e.g., over multiple treatment cycles). In this illustrated example, the TCrtg(Ext) line indicates that the temperature outside the coolant cartridge 130 is maintained at approximately 30° C., for example, by switching the heater ON or OFF at a relatively constant duty cycle, regardless of whether a cooling or recovery phase is occurring. The duty cycle (or pulse width modulation percentage (PWM%)) may be expressed as a ratio or percentage of a period during which the heater is switched ON (or when power greater than a threshold power is applied to the heater). For example, the duty cycle may be defined by the equation: Duty Cycle=PW / T×100%, where PW is the pulse width (e.g., the time during which the heater is switched ON) and T is the duration of the entire ON / OFF cycle.

[0030]

[0041] Referring to FIG. 3A, the cryogenic device 100 may attempt to maintain a relatively constant temperature (e.g., 30° C.) on the outside of the coolant cartridge 130. A relatively constant, relatively small amount of heat is applied throughout the duration of use (e.g., by using a constant, relatively low duty cycle). This approach works if the temperature on the outside of the coolant cartridge 130 reflects the temperature of the internal coolant. However, the temperature applied to the outside of the coolant cartridge 130 is not transferred to the coolant in a fast enough time, and as a result, the temperature on the outside of the coolant cartridge 130 is not a good estimate of the temperature of the internal coolant. As experiments support, there is a large lag between heating the outside of the coolant cartridge 130 and heating the internal coolant. Therefore, while applying a relatively small, constant amount of heat will increase the temperature and pressure over time, this increase occurs at a relatively slow rate. As shown in FIG. 3A, this increase rate may not be sufficient to counter the drop in temperature and pressure caused by the release of coolant during the cooling phase 310. Therefore, in addition to the initial pressure drop corresponding to bracket 312-1, a continuing pressure drop may be observed during the cooling stage 310, as illustrated by the downward sloping pressure curve corresponding to bracket 312-2. The continuing drop shown in FIG. 3A may be suspicious. This is because such continuing fluctuations in pressure during the cooling stage 310 may lead to fluctuations in the coolant flow rate across the cooling stage 310, resulting in the formation of a sub-optimal cryogenic zone. For example, the coolant flow rate may continually decrease during the cooling stage 310 as the pressure continually decreases, resulting in a reduced level of cooling across the cooling stage 310. Therefore, a method of maintaining a constant pressure during the cooling stage 310 may be desirable to achieve constant cooling during the cooling stage 310 in order to form a cryogenic zone with desired characteristics (e.g., having a desired volume and temperature profile). Exemplary methods that may be used to maintain the pressure constant during the cooling stage 310 are described herein.

[0031]

[0042] Moreover, in some embodiments, multiple treatment cycles may be necessary for many cryotherapy treatments to apply an optimal amount of cryotherapy to the target tissue (e.g., nerve) while minimizing collateral damage (e.g., to surrounding tissue). Alternatively or additionally, multiple treatment cycles may be useful to create a "treatment line," which may be, for example, a line of treatment spots that crosses the expected location of the target nerve. More information on treatment lines may be found in U.S. Patent No. 9,295,512, filed September 12, 2013, the entire disclosure of which is incorporated herein by reference in its entirety for all purposes. A further requirement for multiple treatment cycles is that the coolant pressure must be restored to a baseline pressure value after the first treatment cycle before commencing the second treatment cycle. In some embodiments, this pressure recovery may occur during a recovery phase that is separate from the cooling phase (e.g., referring to the example of FIG. 3A, recovery phase 320 occurs immediately after cooling phase 310). Pressure recovery is essential to ensure consistent treatment during repeated treatment cycles. As explained above, pressure fluctuations affect the characteristics of the cryogenic zones that form during a treatment cycle, and starting a second treatment cycle at a pressure value different from the baseline pressure value results in a cryogenic zone that is different during the second treatment cycle than the cryogenic zone that was created during the first treatment cycle. For example, the second treatment cycle may be started at a pressure value less than the baseline pressure value, which would result in a reduced flow rate and ultimately a cryogenic zone that is smaller than the cryogenic zone created in the first treatment cycle. This lack of consistency may result in suboptimal cryotherapy in some cases. The continued absence of adequate pressure recovery during repeated cycles may exacerbate the problem. For example, if the pressure continues to drop between cycles, the cryogenic zones may become smaller and smaller with each treatment cycle. Therefore, the cryogenic device 100 may be configured to use a recovery phase 320 to restore the internal pressure to the baseline pressure value.For example, as shown in FIG. 3A, when the coolant flow is stopped at the end of the cooling phase 310, the pressure begins to rise and continues to rise throughout the recovery phase 320. In the example of FIG. 3A, if a relatively constant, small amount of heat is applied (e.g., enough heat to maintain the outside of the coolant cartridge 130 at a temperature of about 30° C.), this increase in pressure occurs at a relatively slow rate and occurs over a period of more than 300 seconds. This pressure increase is constrained by the rate of heat diffusion through the coolant, which is dependent on the differential heat between the relatively hotter and relatively colder regions. All things being equal, a higher differential heat results in a faster rate of heat diffusion. In the example of FIG. 3A, with a relatively small amount of heat applied to the outside of the coolant cartridge 130, the differential heat can be relatively low. This then leads to a relatively slower rate of heat diffusion, resulting in a relatively slower rise in temperature (and therefore pressure). To allow for full pressure recovery, the recovery phase 320 needs to be extended for a relatively long period of time. This puts a limit on the rate at which multiple cycles can be performed.

[0032]

[0043] FIG. 3B shows an example pressure / temperature curve reflecting the pressure and temperature inside the cryogenic device 100 during a treatment cycle, resulting after the treatment cycle shown in FIG. 3A. Similar to FIG. 3A, FIG. 3B shows an approach that attempts to maintain a relatively constant temperature (e.g., 30° C.) on the outside of the coolant cartridge 130 by applying a relatively constant, relatively small amount of heat (e.g., by using a constant, relatively low duty cycle) throughout the period of use. FIG. 3B differs from FIG. 3A in that the starting pressure is not allowed to recover to the original baseline pressure value, as described above. This is because the heat applied to maintain the temperature on the outside of the coolant cartridge 130 at about 30° C. may not be enough to offset the pressure loss from the previous cycle. Given enough time, the pressure will recover (if the temperature of the coolant matches the temperature on the outside of the coolant cartridge 130 (e.g., 30° C.)), but treatment cycles that occur in relatively rapid succession may not allow enough time. Therefore, the flow rate during the treatment cycle shown in Figure 3B may be less than optimal. Furthermore, since the starting pressure is already relatively low, the difference between the actual pressure value during the cooling phase and the target pressure value is expected to become larger during the next treatment cycle. This is because more heat is required in the next treatment cycle for the coolant pressure to reach the target pressure value.

[0033]

[0044] FIG. 4 shows a simplified cross-sectional schematic of an exemplary coolant cartridge 130 coupled to the needle probe 110 via a coolant pathway. In some embodiments, a heater may be coupled to the coolant cartridge 130 to heat the coolant inside the coolant cartridge 130. In the example shown in FIG. 4, the heater 430 is disposed adjacent to or near the coolant cartridge 130. In some embodiments, one or more temperature sensors (e.g., temperature sensors 440 and 442) may be disposed adjacent to or near the coolant cartridge 130 to measure a temperature outside the coolant cartridge 130 to approximate the temperature inside the coolant cartridge 130. In some embodiments, a supply valve 405 may be disposed along the coolant pathway to control the flow of the coolant. For example, the supply valve 405 may be alternated between an open position and a closed position to prevent downstream coolant flow toward the needle probe 110. In some embodiments, the coolant flow may be adjusted by opening the supply valve to a position between an open position and a closed position. In some embodiments, one or more pressure sensors (e.g., upstream pressure sensor 410 and downstream pressure sensor 412) can be disposed along the coolant path to monitor the pressure of the coolant. Although the simplified schematic diagram of FIG. 4 shows a particular configuration and number of particular elements (e.g., heater 430, temperature sensors 440 and 442, pressure sensors 410 and 412) disposed in particular locations, the present disclosure contemplates that any number and any configuration of these elements can be disposed in any suitable location. For example, heater 430 may be positioned near but not immediately adjacent to the coolant cartridge. As another example, a second heater may be positioned adjacent to the coolant cartridge 130. As another example, the cryogenic device 100 may include only a single pressure sensor (e.g., upstream pressure sensor 410).

[0034]

[0045] In some embodiments, a probe descriptor may be transmitted by the first needle probe 110 including a first flow rate value corresponding to an expected average mass flow rate of coolant through the first needle probe 110 of the cryo-device 100 during a cryotherapy treatment cycle. A processor of the cryo-device 100 (e.g., a first processor disposed on a handpiece portion of the cryo-device 100) may receive the first flow rate value. In some embodiments, the processor of the cryo-device 100 may use the first flow rate value to determine an amount of coolant that will flow through the needle of the needle probe 110 during a particular treatment cycle. For example, the first flow rate value may correspond to n expected average mass flow rates. In this example, if a particular treatment cycle includes a cooling phase having a duration of 20 seconds, the processor may calculate that 20n units of coolant were flowed through the needle of the needle probe 110 during a particular treatment cycle. In some embodiments, each individual needle probe 110 may include information about their respective flow rate values ​​(e.g., as part of an associated probe descriptor) and may transmit the flow rate values ​​(e.g., as part of its probe descriptor) to a processor of the cryogenic device 100. For example, a first needle probe 110 may be replaced with a second needle probe 110. At some point (e.g., immediately after inserting the second needle probe 110 into the probe receptacle 170, after receiving an input to initiate a treatment cycle, etc.), the second needle probe 110 may transmit its own flow rate value to the processor of the cryogenic device 100 for processing. In some embodiments, each needle probe 110 may have a probe descriptor that includes information about predetermined parameters related to timing delivery of a cycle. For example, a probe descriptor for a particular needle probe 110 may include information about the pre-heat time (e.g., during which the skin warmer of the cryostat 100 may be heated to reduce collateral damage to the skin as described above), the cooling phase duration (e.g., during which a valve remains open), the recovery phase duration (e.g., during which a valve is closed), and / or any other suitable parameters. In this example, each of these parameters may be uniquely tailored to the characteristics of the needle probe 110.For example, the duration of the cooling phase for a five needle probe may be shorter than the duration of the cooling phase for a three needle probe.

[0035]

[0046] In some embodiments, the flow rate value of the needle probe 110 may be used by the processor of the cryogenic device 100 to calculate the amount of coolant used and / or remaining in the coolant cartridge 130. The processor of the cryogenic device 100 may calculate these amounts based on the average mass flow rate and the amount of time the supply valve is open to release the coolant. In some embodiments, the flow rate value may be derived from the needle size, the number of needles, and / or other suitable parameters associated with the needle probe 110. In some embodiments, the flow rate value may be determined empirically through testing. For example, a particular probe type may be tested to determine an average flow rate value for each probe type. As another example, each particular needle probe 110 may be tested individually. An individually specified flow rate value may be determined and assigned to the particular needle probe 110. As a result, the probe descriptor transmitted by the particular needle probe 110 includes the individually specified flow rate value. Such individually specified flow rates may be particularly useful when it is not feasible to have tight tolerances in manufacturing (e.g., even two different needle probes of a single type may have varying flow rates due to variations in the dimensions of their respective lumens due to manufacturing variances).

[0036]

[0047] FIG. 5 illustrates an exemplary high level system diagram of the cryogenic device 100. FIG. 5 illustrates the PCBA 175 of the cryogenic device 100 along with other elements that interface with the PCBA 175. In some embodiments, referring to FIG. 5, a piercing element 540 may be housed inside the cryogenic device in a position for piercing the coolant cartridge 130 with a piercing point. Once the coolant cartridge 130 is pierced, the pressurized coolant therein may be fluidly coupled to the coolant path, guiding the needle probe 110 towards a supply valve 405 that may control coolant flow from the coolant cartridge 130 to the needle probe 110 via the coolant path extending through the piercing element 540. In some embodiments, the cryogenic device 100 may include an upstream pressure sensor 410 for measuring the pressure upstream from the supply valve 405 and a downstream pressure sensor 412 for measuring the pressure downstream from the supply valve 405. The supply valve 405 may be opened or closed by any suitable means. For example, a stepper motor 407 (e.g., controllable via a microcontroller unit 510) may be used to move the valve between or between an open and closed position. Typically, when the supply valve 405 is fully open during the cooling phase of a treatment cycle, the upstream pressure is approximately equal to the downstream pressure. Therefore, some embodiments of the cryogenic device 100 may include only an upstream pressure sensor 410, which estimates the pressure inside the coolant cartridge 130 when fluidly coupled to the coolant path (e.g., after the coolant cartridge 130 is pierced by the piercing point 540). Other embodiments of the cryogenic device 100 may include both the upstream pressure sensor 410 and the downstream pressure sensor 412, for example, to diagnose a delivery problem (e.g., to determine if the valve 405 is failing to open or close, or to determine if there is a blockage between the two pressure sensors 410 and 412).

[0037]

[0048] 5, in some embodiments, the cryogenic device 100 may include a microcontroller unit 510 to monitor and operate the cryogenic device 100. In some embodiments, the cryogenic device 100 may include one or more processors as a processor 515. The one or more processors 515 may be part of the microcontroller unit 510 disposed on the PCBA 175. In some embodiments, the processor 515 (or any other suitable circuitry) may determine a first target heater power to be applied to the heater 430 associated with the cryogenic device 100 for a first treatment cycle. In some embodiments, the target heater power is a heater power value configured to generate heat via the heater 430, which can offset pressure / heat losses that occur during the cooling phase of the treatment cycle to stabilize the pressure inside the cryogenic device 100 during the cooling phase. This pressure stabilization may also be optimal to allow for a fast recovery during the recovery phase after the cooling phase, since it can prevent the pressure from dropping to a very low value during the cooling phase. The processor of the cryogenic device 100 can send a signal command circuit associated with the heater 430 to apply a first target heater power to the heater to heat the coolant. In some embodiments, the processor 515 can determine this first target heater power based on the first flow rate value. In some embodiments, as described above, the cryogenic device 100 can theoretically derive the amount of coolant expected to be released from the coolant cartridge 130 when the first needle probe 110 is in use. For example, this can be calculated by multiplying the average mass flow rate (which can be determined, for example, based on the duration the supply valve 405 is open) correlated with the first flow rate value by the duration of the coolant flow to calculate the expected amount of released coolant. If the amount of released coolant can be adjusted with the supply valve 405 (e.g., open the valve by 30%, 50%, etc.), the calculation can be appropriately weighted to account for this adjustment. The cryogenic device 100 can then use the amount of released coolant to estimate the target amount of energy required to compensate for the heat loss due to the release of the coolant.A target heating power can then be derived (e.g., by dividing the target amount of energy by the amount of time expected for the cooling phase). This derived heating power can be applied to the heater 430 to increase the pressure of the coolant inside the cryogenic device 100 to stabilize the pressure during the cooling phase and / or allow pressure recovery during the recovery phase. In some embodiments, the target heating power (or amount of heat required) can alternatively or additionally be empirically derived. For example, a flow rate value can be correlated to the expected coolant discharge rate, or the target heating power (or amount of heat required). In this example, the processor of the cryogenic device 100 can access a look-up table to determine the target heating power. Or alternatively, an empirically derived mathematical model or function can be used to determine the target heating power. The cryogenic device 100 can also include one or more temperature sensors (e.g., thermistors) 440 and 442. This can be used to measure the temperature outside the cartridge (e.g., as reflected in the curve labeled TCrtg(Ext) with reference to FIGS. 3A-3B). A temperature signal corresponding to the measured temperature may be transmitted to the microcontroller unit 510.

[0038]

[0049] In some embodiments, the processor 515 of the cryogenic device 100 can receive an input for a first treatment cycle. For example, a user can actuate an input button that communicates an input signal with the processor 515 of the cryogenic device 100. In response to the input, the processor 515 of the cryogenic device 100 can cause coolant to flow toward the first needle probe 110 (e.g., by opening the supply valve 405) for a period of time that corresponds to a cooling phase of the treatment cycle.

[0039]

[0050] FIG. 6 illustrates an exemplary pressure / temperature graph corresponding to a method of stabilizing the pressure of the coolant by applying a target heater power specifically designed to offset the amount of pressure loss during the cooling phase of the treatment cycle. FIG. 6 illustrates four treatment cycles including a priming cycle followed by cooling phases 1-4. The approach illustrated in FIG. 6 can be used to maintain a relatively constant pressure during the cooling phase when delivering the coolant. As described in more detail below, such an approach has several advantages. In some embodiments, the processor 515 of the cryogenic device 100 can cause the heater to apply a first target heater power during the first cycle to heat the coolant and stabilize the pressure inside the cryogenic device before, during, or after the first treatment cycle. The first target heater power can be applied for a period of time (e.g., during the cooling phase of the first treatment cycle) by any suitable means. In some embodiments, the circuitry associated with the heater can vary the voltage or current supplied to the heater. In other embodiments, the heater may be supplied with a constant voltage and current, but the heater power ultimately applied by the heater over a period of time may be varied by changing the duty cycle of the heater. In these embodiments, the duty cycle may be determined as follows: Duty Cycle=P 標的 ×(R ヒータ / V ヒータ 2 ), wherein P 標的 is the first target heater power, R ヒータ is the resistance of the heater, and V ヒータUsing the equation, where t is the heater voltage, an appropriate duty cycle for applying the target heater power can be determined. Pressure stabilization can involve maintaining the average rate of change of pressure within a predetermined range (or maintaining a relatively constant pressure) during the cooling phase of a treatment cycle. With reference to FIG. 6, a target heater power is applied to the cartridge to keep the pressure during each cooling phase relatively constant. As shown by the TCrtg(Ext) line in the example of FIG. 6, no further heater power is applied to keep the outside of the cartridge at a constant temperature of 30° C. Rather, in this example, a relatively high heater power can be applied to quickly increase the temperature of the coolant during the cooling phase to specifically offset the estimated pressure loss during the cooling phase. For example, the heater can be switched ON during the cooling phase and operated at a duty cycle of about 23% to offset the estimated pressure loss. A relatively high heater power allows heat to be transferred more quickly to the coolant inside the coolant cartridge 130 (and thereby increase the coolant pressure) compared to a lower duty cycle that might otherwise be used to maintain the outside of the cartridge at a constant temperature (e.g., about 30°C).

[0040]

[0051] By applying a targeted heater power specifically tailored to offset pressure losses during the cooling phase, the coolant pressure can be stabilized during the cooling phase to allow for consistent coolant flow during the cooling phase. As shown by the relatively flat pressure lines during cooling phases 1-4 in Figure 6, the pressure remains relatively constant during the cooling phase. This constant pressure during the cooling phase then allows for consistent application of cooling energy during the cooling phase, ultimately resulting in the formation of an optimal cryogenic zone.

[0041]

[0052] Another advantage of this regulated approach (compared to many conventional approaches that simply maintain the temperature constant outside the coolant cartridge 130) is that it shortens the recovery phase, thereby allowing multiple treatment cycles to be performed in a shorter period of time. The shortened recovery phase can be attributed to the fact that no continuous drop in pressure occurs during the cooling phase. For example, with reference to FIG. 3A (where the heater works to keep the temperature constant outside the quote incorporate 130), after an initial pressure drop at the start of the cooling phase, the pressure continues to drop throughout the cooling phase. In contrast, with reference to FIG. 6 (where the heater applies a relatively high target heater power that is specifically regulated to offset the pressure loss), after an initial pressure drop at the start of the cooling phase, the pressure is stabilized during the remainder of the cooling phase. Therefore, at the end of the cooling phase, the overall pressure drop in the approach shown in FIG. 6 is lower than the overall pressure drop in the approach shown in FIG. 3A when compared to its baseline pressure value. A smaller pressure difference (i.e., between the pressure at the end of the cooling phase and the reference pressure value) means that, all things being equal, less time is required to bring the pressure to the reference pressure value. Additionally, the approach shown in Figure 6 allows for a higher heater power to be applied than for the approach shown in Figure 3A, and therefore for faster heat transfer to the coolant, as explained above. Hence, the pressure can return to the reference pressure value at a higher rate as the coolant heats up more quickly.

[0042]

[0053] FIG. 7 shows an example pressure / temperature graph corresponding to a method of real-time pressure monitoring and correction to stabilize the pressure during the cooling phase. By using pressure measurements to directly determine the pressure of the coolant inside the coolant cartridge 130, an accurate real-time pressure can be determined. This is in contrast to many conventional approaches that use temperature measurements made outside the coolant cartridge 130. Hence, the pressure can be monitored and adjusted in real-time to adjust for any deviation from the expected pressure value upon application of an initially determined target heater power. For example, the first target heater power may be a good theoretical estimate of a certain amount of heat that needs to be applied to offset the pressure drop during the cooling phase, but real-world factors may cause such estimates to be inaccurate. For example, manufacturing deviations may result in variations in heater resistance (causing deviations in the amount of heat applied when a specified heater power is applied), supply tube dimensions (causing deviations in the coolant flow rate from the expected flow rate as estimated using the associated flow rate value). Some of these manufacturing variations may be mitigated with individualized testing of the cryogenic device 100 (e.g., testing each needle probe individually and then assigning individual flow rate values ​​for the needle probes as described above) and / or by running a calibration routine to account for the variations. However, such testing and / or calibration is not always feasible, and there may be factors that are not easily tested for or calibrated. Therefore, real-time monitoring and correction may be advantageous. FIG. 7 illustrates an example in which a first target heater power is applied during cooling stage 1 in an attempt to stabilize the pressure during cooling stage 1 after a priming cycle. However, the cryogenic device 100 may determine that the first target heater power is insufficient to maintain a constant average pressure during cooling stage 1, as evidenced, for example, by a negative slope during cooling stage 1 indicating a continuous drop in pressure during cooling stage 1. For example, the processor 515 of the cryogenic device 100 may receive pressure data from a pressure sensor in the cryogenic device during cooling stage 1 and may calculate an average rate of change of pressure during cooling stage 1.In an attempt to stabilize the pressure so that the average pressure remains constant during the next cooling phase (i.e., cooling phase 2), the cryogenic device 100 may adjust the target heater power upward. The processor 515 may determine that the average rate of change of pressure is negative and may calculate an adjusted target heater power for cooling phase 2. In this case, the adjusted target heater power is calculated, at least in part, by adjusting the first target heater power upward by an adjustment value based on the average rate of change of pressure during cooling phase 1. The processor 515 may then cause the heater 430 to apply the adjusted target heater power during cooling phase 2 (e.g., by increasing the duty cycle, by increasing the voltage supplied to the heater 430, etc.). This increase in heater power is illustrated by the TCrtg line in FIG. 7, which shows a sharp increase in temperature around the exterior of the coolant cartridge during cooling phase 2, which is evidence of the increase in heater power. Increasing the heater power allows the average pressure to remain constant during cooling stage 2, as shown by the relatively flat pressure curve during cooling stage 2 in FIG.

[0043]

[0054] Similarly, the cryogenic device 100 may adjust the heater power in response to a positive rate of pressure change. For example, cooling stage 3 of FIG. 7 shows a positive change in pressure. This may be caused by the heater power being potentially too high. In some embodiments, the processor 515 of the cryogenic device 100 may determine that the average rate of change of pressure during cooling stage 3 is positive beyond a predetermined range and calculate an adjusted target heater power for the next cooling stage (i.e., cooling stage 4). This adjusted target heater power may be calculated, for example, at least in part, by adjusting the target heater power applied during cooling stage 3 downward by an adjustment value. The adjustment value may be based on the average rate of change of pressure that occurred during cooling stage 3. The processor 515 then causes the heater 430 to apply the adjusted target heater power during cooling stage 4. This may result in a relatively constant average pressure during cooling stage 4, as shown by the relatively flat pressure curve in FIG. 7 during cooling stage 4. The following table shows exemplary heater power adjustments made during each of the cooling stages shown in FIG. 7, as made by adjusting the heater duty cycle. [Table 1]

[0044]

[0055] In some embodiments, the adjustment value may be determined based on the magnitude of the average rate of change of pressure. For example, a relatively high adjustment value may be determined for a relatively high magnitude, and a relatively low adjustment value may be determined for a relatively low magnitude. In some embodiments, the processor 515 has access to a lookup table, or alternatively, an empirically derived mathematical model or function may be used to determine the appropriate adjustment value. In some embodiments, the effect of heater power adjustment on the slope of the pressure during delivery may be characterized for each probe type, and the cryogenic device 100 bases the heater power adjustment on this characterization. This allows for a very accurate estimation of the appropriate correction to be made for any probe type and measured slope. For example, all conditions being equal, a cryogenic apparatus 100 receiving a probe descriptor indicating that the attached probe is a three needle probe can calculate a first adjustment value, while a cryogenic apparatus 100 receiving a probe descriptor indicating that the attached probe is a five needle probe can calculate a second adjustment value that is different from the first adjustment value (e.g., a higher adjustment value may be calculated for a five needle probe because a five needle probe may have a higher average mass flow rate such that a higher heater power adjustment may be required to affect a desired change in pressure). As another example, all conditions being equal, a first adjustment value may be calculated for a single needle probe with a 90 mm needle and a second adjustment value may be calculated for a three needle probe with a 9 mm needle (e.g., a higher adjustment value may be calculated for a 90 mm single needle probe because a 90 mm single needle probe may have a higher average mass flow rate than a 9 mm three needle probe). In other embodiments, the cryogenic device 100 may apply coarse adjustments (e.g., 10% duty cycle increments) if the average rate of change of pressure during the cooling phase exceeds some specified threshold, and finer increments (e.g., 2% duty cycle increments) for average rate of change of pressure below this specified threshold.Such an approach can be expanded to multiple thresholds with additional adjustment increments (eg, a higher threshold where the pressure is adjusted in 20% duty cycle increments).

[0045]

[0056] In some embodiments, the target heater power may be adjusted based on the value of the pressure before the cooling stage. For example, if the pressure value before a particular cooling stage is determined to be less than an optimal baseline pressure value, the cryo-device 100 may adjust the resulting target heater power delivered during the particular cooling stage upward. As another example, if the pressure value before a particular cooling stage is determined to be greater than an optimal baseline pressure value, the cryo-device 100 may adjust the resulting target heater power delivered during the particular cooling stage downward. These types of monitoring and adjustments may be desirable in that they provide macro-level stabilization that can address deteriorating baseline levels that may have deteriorated over multiple treatment cycles.

[0046]

[0057] In some embodiments, the target heater power may be adjusted based on a comparison of the values ​​of the pressure before and after the cooling phase. For example, the cryostat may determine a first pressure of the cryostat 100 immediately prior to the cooling cycle of a first treatment cycle, and may subsequently determine a second pressure of the cryostat 100 immediately prior to the cooling cycle of a second treatment cycle. In this example, the cryostat 100 then calculates a second target heater power for the second treatment cycle. This second target heater power is calculated at least in part by adjusting the first target heater power upward or downward based on a difference determined between the first pressure and the second pressure. For example, if the second pressure is lower than the first pressure, the target heater power may be adjusted upward. As another example, if the second pressure is higher than the first pressure, the target heater power may be adjusted downward.

[0047]

[0058] In some embodiments, the cryogenic device 100 may also monitor the voltage of its power supply during use. In some embodiments, this voltage may serve as an estimate for the voltage across the heater 430, which may then be used to ensure that the heater 430 is accurately delivering a specified target heater power. For example, with reference to FIG. 5, the microcontroller unit 510 of the cryogenic device 100 may monitor the voltage of the battery 520 (V バッテリ ) from a battery 520 (e.g., a lithium ion battery cell). In this example, V バッテリ is the equation for calculating the duty cycle, for example as above, i.e. Duty Cycle = P 標的 ×(R ヒータ / V ヒータ 2 ) to V ヒータ The battery voltage can change over time due to various factors, such as the amount of charge remaining in the battery. For example, the battery voltage can vary from 4.2V to 3.2V depending on the remaining charge. Even small variations in the battery voltage can cause a large change in V ヒータ This can have a significant effect on the duty cycle calculation because V is squared. Hence the updated V ヒータ By calculating the duty cycle with an estimate of V, an appropriate duty cycle can be used, thereby reducing the possibility of pressure fluctuations due to an inaccurate duty cycle calculation. ヒータ The current of a power supply that may be used to conduct the

[0048]

[0059] FIG. 8 illustrates an exemplary pressure / temperature graph of multiple treatment cycles, including a treatment cycle that indicates a problem with the cryogenic device 100. In some embodiments, the cryogenic device 100 may use pressure measurements as a means to indicate a problem with the cryogenic device 100. In some embodiments, an average rate of change of pressure (or an overall change in pressure) that is higher than the expected average rate of change of pressure (or the expected overall change in pressure) may indicate a problem with the cryogenic device 100 that may require more action than simply adjusting heater power as described above. For example, if the change in pressure exceeds the expected change in pressure (or if the rate of change of pressure exceeds the expected rate of change of pressure) by a threshold magnitude, the cryogenic device 100 may determine that a problem with the cryogenic device 100 exists. With reference to FIG. 8, for example, when the average rate of change of pressure (e.g., during the cooling phase) is negative by more than a threshold magnitude ratio (e.g., as indicated by a large negative slope during cooling phase 3), the cryogenic device 100 may determine that the amount of coolant inside the coolant cartridge 130 may be critically reduced. Such a pressure change rate that exceeds the threshold magnitude ratio reflects a lack of coolant in the system, allowing the pressure to be increased sufficiently. Additionally or alternatively, the cryogenic device 100 may determine that a similar problem may exist if the pressure does not recover to the baseline pressure value after a recovery phase following a cooling phase (e.g., the recovery phase after cooling phase 3, with reference to FIG. 8). As another example, when the average rate of change of pressure is positive beyond the threshold magnitude ratio compared to the expected rate of change of pressure, the cryogenic device 100 may determine that a problem with the delivery of the coolant exists (e.g., a blocked or obstructed coolant path, a problem with the supply valve 405). In these cases, a processor (e.g., processor 515) of the cryogenic device 100 may generate a notification in some embodiments indicating a problem with the cryogenic device. In some embodiments, the notification may identify the particular problem that the cryogenic device 100 determines is likely. In some embodiments, the notification may be displayed on a display device (e.g., a screen disposed on the cryogenic device 100, a screen on an external device, etc.).

[0049]

[0060] FIG. 9 shows a simplified schematic diagram of the cryostat 100 in use. As shown, the needle 115 of the needle probe can be inserted into and beyond the patient's skin 810 such that a distal portion of the needle 115 is adjacent to the target tissue (e.g., neural tissue). In some embodiments, an operator can select the needle probe to be sized such that when the tissue engaging surface 920 is brought into contact with the skin 910, the needle 115 extends distally beyond the non-target tissue and adjacent to the target tissue. In some embodiments, once the needle 115 is positioned, the operator can provide an input to the cryostat 100 (e.g., by actuating a button, tapping a user interface element on a touch screen), causing the controller to open the supply valve 405, thereby allowing coolant to flow from the cartridge 130 through the coolant pathway to the lumen of the needle 115. The needle 115 can be configured such that a distal portion of the needle 115 is cooled more than a proximal portion of the needle 115. Therefore, the distal portion of the needle 115 can create a cooling zone around the target tissue, as shown in FIG.

[0050]

[0061] FIG. 10 illustrates an exemplary method 1000 for stabilizing pressure within a cryogenic device. The method may include, at step 1010, receiving a first flow rate value, the first flow rate value corresponding to an expected average mass flow rate of coolant through a first needle probe of the cryogenic device during a cryotherapy treatment cycle. At step 1020, the method may include determining a first target heater power to be applied to a heater associated with the cryogenic device for the first treatment cycle and configured to heat the coolant based on the first flow rate value. At step 1030, the method may include receiving an input for the first treatment cycle. At step 1040, the method may include directing coolant to the first needle probe in response to the input for a period of time. At step 1050, the method may include directing the heater to apply the first target heater power during the first cycle to heat the coolant and stabilize the pressure within the cryogenic device during or after the first treatment cycle. Certain embodiments may repeat one or more steps of the method of Figure 10 and may include appropriate additional or modified steps as desired. For example, as described in further detail above, the heater power may be adjusted for successive treatment cycles, and the adjusted heater power may be applied during a subsequent second treatment cycle (e.g., if the first heater power is determined to result in a negative average rate of change of pressure during the cooling phase of the first treatment cycle below a predetermined range, a second target heater power may be calculated for the second treatment cycle by adjusting the first heater power upward). Although this disclosure describes and illustrates certain steps of the method of Figure 10 as occurring in a particular order, this disclosure contemplates any suitable steps of the method of Figure 10 in any suitable order. Moreover, although this disclosure describes and illustrates an exemplary method for stabilizing pressure within a cryogenic device that includes certain steps of the method of FIG. 10, this disclosure contemplates any suitable method for stabilizing pressure within a cryogenic device that includes any suitable steps, which may include all, some, or none of the steps of the method of FIG. 10, as appropriate.Additionally, although this disclosure describes and illustrates particular components, devices, or systems that perform particular steps of the method of FIG. 10, this disclosure contemplates any suitable combination of any suitable components, devices, or systems that perform any suitable steps of the method of FIG.

[0051]

[0062] Although the exemplary embodiments have been described in some detail for clarity of understanding, by way of example, certain modifications, changes and adaptations may be implemented and / or will be apparent to those skilled in the art.

Claims

1. 1. A cryogenic device comprising: a coolant source containing a pressurized coolant; a coolant pathway configured to direct the coolant towards a needle probe including one or more needles, the coolant pathway configured to deliver cryotherapy to a target tissue through the one or more needles; A heater and 1. A processor comprising: receiving a first flow value corresponding to an expected average mass flow rate of coolant through a first needle probe of the cryogenic device during a cryotherapy treatment cycle; determining a first target heater power to be applied to a heater associated with the cryogenic device and configured to heat the coolant for a first treatment cycle based on the first flow rate value; receiving an input for the first treatment cycle; directing the coolant toward the first needle probe for a period of time in response to the input; applying the first target heater power to the heater during the first treatment cycle to heat the coolant and stabilize pressure within the cryogenic device during or after the first treatment cycle; receiving pressure data from a pressure sensor of the cryogenic device during the first treatment cycle; calculating an average rate of change of pressure during a cooling phase of the first treatment cycle based on the received pressure data; and a processor configured to calculate a second target heater power for a second treatment cycle, the second target heater power being calculated at least in part by adjusting the first target heater power upward or downward by an adjustment value based on the average rate of change of pressure; A low-temperature device comprising:

2. 10. The cryogenic device of claim 1, wherein the first target heater power is defined such that an average rate of change of pressure during a cooling cycle of the first treatment cycle remains within a predefined range.

3. 2. The cryogenic apparatus of claim 1, wherein the processor is further configured to determine that the average rate of change of pressure is negative, and wherein the second target heater power is calculated at least in part by adjusting the first target heater power upward by the adjustment value.

4. 2. The cryogenic apparatus of claim 1, wherein the processor is further configured to determine that the average rate of change of pressure is positive, and wherein the second target heater power is calculated at least in part by adjusting the first target heater power downward by the adjustment value.

5. 3. The cryogenic device of claim 1 or 2, wherein the heater is coupled to a coolant source associated with the cryogenic device.

6. 6. The cryogenic device of claim 5, wherein the cryogenic device comprises a handpiece portion, the coolant source and the first needle probe are directly connected to the handpiece portion, and the coolant pathway extends between the coolant source and the first needle probe.

7. the processor is further configured to determine a target duty cycle required to apply the first target heater power; applying the first target heater power to operate the heater for the target duty cycle; 3. A cryogenic device according to claim 1 or 2.

8. 8. The cryogenic apparatus of claim 7, wherein the target duty cycle is determined based on a power of an equation: Duty Cycle = P Target x (R Heater / V Heater 2), where P Target is the first target heater power, R Heater is the resistance of the heater, and V Heater is the voltage of the heater.

9. 10. The cryogenic device of claim 8, wherein the processor is further configured to monitor a voltage of a power supply coupled to the heater to estimate a real-time value of VHeater.

10. 3. The cryogenic device of claim 1 or 2, wherein the processor is configured to apply the first target heater power by adjusting an amount of current or voltage applied to the heater.

11. The cryogenic device of claim 1 , wherein the adjustment value is determined based on a magnitude of the average rate of change of pressure.

12. the processor determining that the average rate of change of pressure is greater than a threshold magnitude; The cryogenic device of claim 1 , further configured to generate a notification indicating a problem with the cryogenic device based on the determination.

13. 13. The cryogenic system of claim 12, wherein the average rate of change of pressure is negative and the notification identifies the problem as a reduced coolant source based on the average rate of change of pressure.

14. The method of claim 12 , wherein the average rate of change of pressure is positive, and the notification identifies the problem as a blockage or obstruction in a coolant path based on the average rate of change of pressure.

15. The processor, determining a first pressure in the cryogenic device prior to a cooling cycle of the first treatment cycle; and further configured to determine a second pressure in the cryogenic device prior to a cooling cycle of a second treatment cycle; The second target heater power is adjusting the first target heater power upward when the second pressure is lower than the first pressure; or adjusting the first target heater power downward when the second pressure is greater than the first pressure; 3. The cryogenic apparatus of claim 1 or 2, wherein the temperature is calculated at least in part by:

16. the first needle probe is replaced with a second needle probe; the processor receiving a second flow rate value corresponding to an expected average mass flow rate of coolant through the second needle probe during a cooling phase of a cryotherapy treatment cycle; 3. The cryogenic device of claim 1, further configured to determine a new target heater power to be applied by the heater for a treatment cycle performed with the second needle probe based on the second flow rate value.

17. 3. The cryogenic device of claim 1 or 2, wherein the first treatment cycle includes a cooling phase and a recovery phase, and the first targeted heater power is applied during the cooling phase.

Images