The present disclosure generally relates to cryotherapy and, in particular, to cryotherapy systems and methods of treatment for ear, nose, and/or throat disorders.
In general, thermal therapies involve treating tissue by inducing a temperature change that selectively induces alterations of the tissue, either temporarily or permanently. Depending on the tissue targeted for treatment, this thermal alteration may provide various benefits, including destroying the tissue and/or altering nerve signaling pathways. Ablation may be accomplished by applying heat (for example, with radiofrequency, laser, microwave, high intensity focused ultrasound (HIFU), or resistive heating methods) or by applying cooling energy (for example, using cryoablation techniques).
The term “cryotherapy” describes a class of thermal therapies that involve inducing a relatively cold temperature in a tissue, and includes therapies generally referred to as therapeutic hypothermia and cryoablation. Depending on the temperatures and exposure times involved, the clinical goals of various cryotherapies may range from improved tissue healing/recovery (e.g., as with therapeutic hypothermia employed during physical therapy sessions) to selective tissue damage or destruction (e.g., during cryoablation used for neuromodulation or tumor-destruction purposes). Any tissue alteration introduced during cryotherapy may be temporary or permanent, depending on the tissue treated and one or more characteristics of the therapy applied to the tissue.
Rhinitis is defined as inflammation of the membranes lining the nose, and is characterized by nasal symptoms including itching, rhinorrhea, and/or nasal congestion. Chronic rhinitis affects millions of people and is a leading cause for patients to seek medical care. Medical treatment has been shown to have limited effects for chronic rhinitis sufferers and requires daily medication use or onerous allergy treatments, and up to 20% of patients may be refractory. Selectively interrupting the Posterior Nasal Nerves (PNN), Accessory Posterior Nasal Nerves (APNN), and/or other nervous structures in patients with chronic rhinitis (e.g., by applying cryotherapy within the nasal cavity to cryoablate these nerves) has been shown to improve symptoms with limited to elimination of side effects.
Other disorders in the ear, nose, or throat can also be treated using cryotherapy.
In an example, a cryotherapy system includes a base station, a cryotherapy applicator, and a cryogen conduit. The base station includes a housing including a canister receptacle that is configured to receive a canister containing a cryogen. The housing defines an internal chamber. The base station also includes a cryogen outlet on an exterior surface of the housing. The cryogen outlet is configured to output the cryogen from the base station. The base station further includes a cryogen flow assembly in the internal chamber of the housing. The cryogen flow assembly is configured to supply the cryogen from the canister to the cryogen outlet. The base station also includes a controller configured to control a flow of the cryogen through the cryogen flow assembly from the canister to the cryogen outlet.
The cryotherapy applicator includes a handle that is configured to be gripped by a user during a cryotherapy procedure. The handle has a proximal end and a distal end. The cryotherapy applicator also includes a shaft extending from the distal end of the handle, and an end-effector coupled to the shaft. The end-effector is configured to use the cryogen to ablate a target tissue.
The cryogen conduit is configured to couple the cryotherapy applicator to the base station and supply the cryogen from the base station to the cryotherapy applicator. The cryogen conduit has (i) a first end extending from the proximal end of the handle of the cryotherapy applicator and (ii) a second end configured to couple to the cryogen outlet of the base station. An entirety of the cryotherapy applicator is movable relative to an entirety of the base station while the cryogen conduit couples the cryotherapy applicator to the base station.
In another example, a method of operating a cryotherapy system is described. The method includes coupling a canister containing a cryogen to a canister receptacle of a base station, and coupling, using a cryogen conduit, a cryotherapy applicator to a cryogen outlet on an exterior surface of a housing of the base station. The cryogen conduit has (i) a first end extending from a proximal end of a handle of the cryotherapy applicator and (ii) a second end configured to couple to the cryogen outlet of the base station.
The cryotherapy applicator includes the handle that is configured to be gripped by a user during a cryotherapy procedure. The handle has the proximal end and a distal end. The cryotherapy applicator also includes a shaft extending from the distal end of the handle, and an end-effector coupled to the shaft. The end-effector is configured to use the cryogen to ablate a target tissue.
The method also includes, while the cryogen conduit couples the cryotherapy applicator to the base station, moving an entirety of the cryotherapy applicator relative to an entirety of the base station to insert the end-effector in a nasal cavity and navigate the end-effector to the target tissue. After navigating the end-effector to the target tissue, the method includes supplying the cryogen from the canister in the base station to the end-effector to ablate the target tissue.
The features, functions, and advantages that have been discussed can be achieved independently in various embodiments or may be combined in yet other embodiments further details of which can be seen with reference to the following description and drawings.
The novel features believed characteristic of the illustrative embodiments are set forth in the appended claims. The illustrative embodiments, however, as well as a preferred mode of use, further objectives and descriptions thereof, will best be understood by reference to the following detailed description of an illustrative embodiment of the present disclosure when read in conjunction with the accompanying drawings, wherein:
Disclosed embodiments will now be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all of the disclosed embodiments are shown. Indeed, several different embodiments may be described and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are described so that this disclosure will be thorough and complete and will fully convey the scope of the disclosure to those skilled in the art.
By the term “approximately” or “substantially” with reference to amounts or measurement values described herein, it is meant that the recited characteristic, parameter, or value need not be achieved exactly, but that deviations or variations, including for example, tolerances, measurement error, measurement accuracy limitations and other factors known to those of skill in the art, may occur in amounts that do not preclude the effect the characteristic was intended to provide.
In this arrangement, when the cryotherapy treatment is to be performed on multiple target tissues, a medical practitioner has to remove a first canister 118 and insert a second canister 118. For instance, a procedure for treating target tissues in two nostrils of a patient may include the following steps according to one example. First, the medical practitioner may remove a cap 120 from the housing 110, insert a first canister 118 into the canister receptacle 116, and then recouple the cap 120 to the housing 110. The medical practitioner can then grasp the housing 110 and insert the end-effector 114 and the elongated shaft 112 into a first nostril of the patient, and navigate the end-effector 114 to a first target tissue in the first nostril. For some procedures, the medical practitioner may perform the insertion and navigation while holding the housing 110 with one hand, and holding a separate endoscope with the other hand. The endoscope generally has a rigid shaft that extends along and adjacent to the elongated shaft 112 of the cryotherapy system 100.
While the end-effector 114 is located at the first target tissue, the user input device 122 is actuated to supply the cryogen from the first canister 118 to the end-effector 114, which uses the cryogen to apply the cryotherapy to the first target tissue. In procedures in which the medical practitioner holds the housing 110 in one hand and the endoscope in the other hand, a second medical practitioner may assist by actuating the user input device 122. After applying cryotherapy to the first target tissue, the end-effector 114 (and the endoscope) may be removed from the first nostril.
Also, after performing the cryotherapy on the first target tissue, the first canister 118 is be depleted of sufficient cryogen to treat the second target tissue. As such, the medical practitioner may remove the first canister 118 from the canister receptacle 116, and insert a second canister 118 into the canister receptacle 116. The medical practitioner can then grasp the housing 110 and insert the end-effector 114 and the elongated shaft 112 into a second nostril of the patient, and navigate the end-effector 114 to a second target tissue in the second nostril. After the end-effector 114 is located at the second target tissue, the user input device 122 is actuated again to supply the cryogen from the second canister 118 to the end-effector 114, which uses the cryogen to apply cryotherapy to the second target tissue in the second nostril. In some implementations, the entire cryotherapy system 100 may be disposed of after treating the first target tissue in the first nostril and the second target tissue in the second nostril.
Although the cryotherapy system 100 shown in
Referring now to
As shown in
Within examples, an entirety of the cryotherapy applicator 232 is movable relative to an entirety of the base station 230 while the cryogen conduit 234 couples the cryotherapy applicator 232 to the base station 230. For instance, the cryogen conduit 234 can have a flexibility that allows the cryotherapy applicator 232 to move relative to the base station 230. In an implementation, the cryotherapy applicator 232 can move with six degrees of freedom relative to the base station 230 (e.g., including three degrees of freedom for translation and three degrees of freedom for rotation). This can facilitate navigating the cryotherapy applicator 232 around bone and tissue structures in the ear, the nose, and/or the throat to reach the target tissue. However, in other examples, the cryotherapy applicator 232 can move with less than six degrees of freedom relative to the base station 230.
In this arrangement, a medical practitioner can hold and move the cryotherapy applicator 232 relative to the patient while the base station 230 remains stationary relative to the patient. This can help to solve a number of technical challenges that may be encountered with existing cryotherapy systems.
For example, existing cryotherapy systems generally require the medical practitioner to hold and support all of the components of the cryotherapy systems in their hand while performing the cryotherapy procedure. By contrast, the components of the cryotherapy system 200 shown in
Additionally, as described below, providing a first set of the components in the base station 230 and a second set of components in the cryotherapy applicator 232 can allow the cryotherapy system 200 to include features that may be too large to be practical in existing cryotherapy systems in which the medical practitioner holds all components in their hand(s) at the same time while performing the cryotherapy procedure (e.g., the cryotherapy system 100 shown in
As shown in
Because the base station 230 includes the canister receptacle 240 and the base station 230 is not held by the medical practitioner while performing the cryotherapy treatment on the patient, the canister 242 can store a greater amount of the cryogen 236 than existing cryotherapy systems in which the medical practitioner holds the cryogen canister while performing the cryotherapy treatment. In an example, the canister 242 can contain an amount of the cryogen 236 that is greater than or equal to an amount of the cryogen 236 that is used to treat at least two target tissues. This can allow the medical practitioner to more efficiently treat a plurality of target tissues as the medical practitioner does not need to swap out the canister 242 after treating each target tissue.
In one example implementation, the canister 242 can contain an amount of the cryogen 236 that is greater than or equal to an amount of cryogen 236 that is used to treat a first target tissue in a first nostril and a second target tissue in a second nostril. For instance, in one existing cryotherapy system (e.g., the cryotherapy system 100 shown in
In one example, the canister 242 can contain greater than 10 mL of the cryogen 236. As noted above, this can allow the canister 242 to store an amount of the cryogen 236 that can be used to treat a first target tissue in a first nostril of a patient and a second target tissue in a second nostril of the patient without changing the canister 242 between these treatments. In another example, the canister 242 can contain between approximately 10 mL and approximately 32 mL of the cryogen 236 (e.g., approximately 20 mL). In another example, the canister 242 can contain between approximately 32 ml and approximately 60 liters (L) of the cryogen 236. This can allow the cryotherapy system 200 to store an amount of the cryogen 236 that can be used to treat a relatively large number of target tissues (e.g., including a plurality of target tissues on one patient and/or a plurality of target tissues over a plurality of patients). Although it may be beneficial to provide the canister 242 with relatively greater volumes to store relatively greater amounts of the cryogen 236, the canister 242 can store a quantity of the cryogen 236 that is approximately less than or equal to 10 mL in some instances.
In one example, the canister receptacle 240 can be configured to receive only a single type of the canister 242 having a single size. In other examples, the canister receptacle 240 can be configured to receive (i) a first canister 242 having a first size and (ii) a second canister 242, which has a second size that is greater than the first size of the first canister 242. As such, the first canister 242 can contain a first volume of the cryogen 236 and the second canister 242 can contain a second volume of the cryogen 236, where the second volume is greater than the first volume.
As shown in
For instance, in
Although
Additionally, in
As described, the canister 242 and the canister receptacle 240 of the base station 230 can be configured such that the canister 242 is removably coupled to the base station 230 to provide a quantity of the cryogen 236 for use during one or more cryotherapy treatments. In an alternative example, the canister 242 can be permanently coupled to the canister receptacle 240. In such alternative examples, the canister 242 can be a refillable structure that is at a fixed position in the housing 238 of the base station 230.
Referring again to
As examples, the cryogen flow assembly 254 can include one or more valves and/or one or more lumens that define a flow path for the cryogen 236 between the canister receptacle 240 and the cryogen outlet 252. The one or more valves can be operable to control a flow of the cryogen 236 through the lumen(s). In one example, each valve can be actuatable between (i) a closed state in which the valve prevents the cryogen 236 from flowing through the lumen(s) from the canister receptacle 240 to the cryogen outlet 252, and (ii) an open state in which the valve allows the cryogen 236 to flow through the lumen(s) from the canister receptacle 240 to the cryogen outlet 252. In this arrangement, the valve of the cryogen flow assembly 254 can be in the closed state prior to and/or after applying cryotherapy to the target tissue, and the valve of the cryogen flow assembly 254 can be in the open state while applying the cryotherapy to the target tissue during a cryotherapy treatment.
In some examples, the cryogen flow assembly 254 can have only the closed state and the open state. This can help to simplify the design in implementations in which the cryogen 236 may be substantially supplied at the cryogen outlet 252 at a constant flow rate. However, in other examples, the cryogen flow assembly 254 can be configured to supply the cryogen 236 at a plurality of flow rates. In such examples, for instance, the valve(s) of the cryogen flow assembly 254 can have a plurality of intermediate states between the closed state and the open state in which each intermediate state provides a respective flow rate of the plurality of flow rates. Supplying the cryogen 236 at a flow rate selected from among a plurality of flow rates can help to more precisely and granularly control the thermal energy applied to the target tissue during the cryotherapy treatment.
In some examples, the base station 230 can include a controller 256 that is configured to control a flow of the cryogen 236 through the cryogen flow assembly 254 from the canister 242 to the cryogen outlet 252. For example, the controller 256 can be in communication with the one or more valves of the cryogen flow assembly 254 an the controller 256 can be operable to transmit a control signal to the valve(s) to cause valve(s) to actuate to a selected state from among a plurality of states (e.g., the open state, the intermediate state(s), and the closed state) to control the flow of the cryogen 236 through the cryogen flow assembly 254. As described in further detail below, the controller 256 can be configured to transmit the control signal responsive to at least one trigger selected from among a group of triggers consisting of: a user input and/or a sensor signal from a sensor of the cryotherapy system 200.
The controller 256 can be implemented using hardware, software, and/or firmware. For example, the controller 256 can include one or more processors and a non-transitory computer readable medium (e.g., volatile and/or non-volatile memory) that stores machine language instructions or other executable instructions. The instructions, when executed by the one or more processors, may cause the controller 256 to carry out the various operations of the cryotherapy system 200 described herein.
As noted above, the cryogen conduit 234 is configured to couple the cryotherapy applicator 232 to the base station 230 and supply the cryogen 236 from the base station 230 to the cryotherapy applicator 232. For example, the cryogen conduit 234 can have (i) a first end extending from a proximal end of a handle 258 of the cryotherapy applicator 232 and (ii) a second end configured to couple to the cryogen outlet 252 of the base station 230. In one example, the first end of the cryogen conduit 234 can be fixedly coupled to the handle 258 of the cryotherapy applicator 232 whereas the second end of the cryogen conduit 234 can be removably coupled to the cryogen outlet 252 of the base station 230. In another example, the first end of the cryogen conduit 234 can be removably coupled to the handle 258 of the cryotherapy applicator 232 whereas the second end of the cryogen conduit 234 can be fixedly coupled to the cryogen outlet 252 of the base station 230. In yet another example, the first end of the cryogen conduit 234 can be removably coupled to the handle 258 of the cryotherapy applicator 232 whereas the second end of the cryogen conduit 234 can be removably coupled to the cryogen outlet 252 of the base station 230.
Removably coupling at least one of the first end or the second end of the cryogen conduit 234 to the handle 258 of the cryotherapy applicator 232 or the cryogen outlet 252 of the base station 230, respectively, can allow for the base station 230 to be used with a plurality of cryotherapy applicators 232. This can facilitate reusing the base station 230 for a plurality of treatments and/or a plurality of patients with different cryotherapy applicators 232. Additionally, this can provide for the cryotherapy applicator 232 to be fabricated in a manner that allows for the cryotherapy applicator to be disposable while the base station 230 is reusable. Additionally or alternatively, the removable coupling(s) can facilitate using the base station 230 with a plurality of cryotherapy applicators 232 having different configurations (e.g., a different size, a different shape, and/or a different material properties relative to each other), as described in further detail below.
As examples, the first end and/or the second end of the cryogen conduit 234 can be permanently coupled to the handle 258 of the cryotherapy applicator 232 and/or the cryogen outlet 252 of the base station 230 by welding, an adhesive, a barb fitting, and/or another form of coupling that cannot be repeatedly decoupled and recoupled by a medical practitioner. As another example, the permanent coupling can be provided by integrally forming at least a portion of the cryogen conduit 234 with at least a portion of base station 230 and/or the cryotherapy applicator 232. Also, as examples, the first end and/or the second end of the cryogen conduit 234 can be removably coupled to the handle 258 of the cryotherapy applicator 232 and/or the cryogen outlet 252 of the base station 230 by a threaded engagement coupling, a bayonet connector coupling, a quick-connect coupling, and/or a friction fit coupling.
As shown in
In general, the handle 258 can be configured to facilitate a user gripping and manipulating the cryotherapy applicator 232 while performing cryotherapy. For example, the handle 258 can have a shape and/or a size that can facilitate a user performing cryotherapy by manipulating the cryotherapy applicator 232 using a single hand. In one implementation, the handle 258 can have a shape and/or a size that facilitates the user holding the cryotherapy applicator 232 in a writing utensil gripping manner (e.g., the handle 258 can have an axis that is substantially parallel to an axis of the shaft 260). For instance, the handle 258 of the cryotherapy applicator 232 can be elongated along a longitudinal axis such that the handle 258 is configured to be held by the user using a pencil grip. In another implementation, the handle 258 can have a shape and/or a size that facilitates the user holding the handle 258 in a pistol gripping manner (e.g., the handle 258 can have an axis that is transverse to an axis of the shaft 260). Additionally or alternatively, the handle 258 can facilitate gripping and manipulating the cryotherapy applicator 232 by having a shape and/or a size that is greater than a shape and/or a size of the shaft 260.
The shaft 260 can be configured to be at least partially inserted in a body cavity of a patient, where the body cavity includes a cavity in an ear, a nose, or a throat of the patient. For instance, the shaft 260 can be elongated along a longitudinal axis between a proximal end and a distal end of the shaft. In this arrangement, the proximal end of the shaft 260 can extend from a distal portion of the housing, and the distal end of the shaft 260 can be coupled to the end-effector 262.
In one example, the shaft 260 can have a diameter between approximately 1 mm and approximately 4 mm. Additionally, for example, the shaft 260 can be made from stainless Steel and/or semi-rigid polymer (e.g., such as Nylon or Pebax).
As noted above, the end-effector 262 is configured to use the cryogen 236 to apply thermal energy to the target tissue. In one example, the end-effector 262 can include a balloon into which the cryogen 236 (e.g., in the form of a compressed liquid) can expand as a gas. As another example, the end-effector 262 can include a metallic plate, which can be chilled through contact with the cryogen 236 (e.g., in the form of a circulating cooled fluid). In these examples, the end-effector 262 includes an intermediary feature (e.g., the balloon and/or the metallic plate) that transfers the thermal energy from the cryogen 236 to the target tissue. This can beneficially help to improve the uniformity of the distribution of cold temperatures applied across a targeted region of tissue. This indirect application of cooling can also prevent the cryogen 236 from direct exposure to the body in unwanted regions.
In some implementations, the end-effector 262 can have an active surface that is configured for contacting the target tissue and an inactive surface that is configured to positioned at or adjacent to another tissue. For example, the end-effector 262 include the active surface and an inactive surface such that the end-effector 262 applies the thermal energy to the target tissue contacting the active surface and does not apply the thermal energy to other tissue contacting the inactive surface. This can help to apply thermal energy in a relatively targeted manner to treat a specific target tissue.
In other implementations, an entirety of the end-effector 262 can be active such that the end-effector 262 applies the thermal energy omni-directionally. This can help to apply the thermal energy more broadly and, in some instances, can help to reduce a time for performing a cryotherapy procedure.
As shown in
In one example, the user input device 266 is configured to transmit to a control signal to the controller 256 to cause the controller 256 to control the flow of the cryogen 236 to the end-effector 262. In another example, the user input device 266 can be configured to mechanically actuate a valve of the cryogen flow system 264 and/or a valve of the cryogen flow assembly 254 to control the flow of the cryogen 236 from the base station 230 to the end-effector 262.
In some examples, the cryotherapy system 200 can include a foot pedal 267 that can be operable to control the flow of the cryogen 236 in addition or in alternative to the user input device 266 of the cryotherapy applicator 232. As shown in
In some examples, the base station 230 can include a user interface 268 that can be operable to control the flow of the cryogen 236 in addition or in alternative to the user input device 266 of the cryotherapy applicator 232 and/or the foot pedal 267. For instance, as shown in
In this arrangement, the controller 256 can receive the user input from the base-station input device 270 and the controller 256 can perform one or more actions responsive to the one or more inputs received via the base-station input device 270. As examples, the one or more actions can include at least one action selected from a group of actions consisting of: (i) starting a flow of the cryogen 236, (ii) stopping the flow of the cryogen 236, (iii) increasing a flow rate of the cryogen 236, and (iv) decreasing a flow rate of the cryogen 236. In one implementation, the base-station input device 270 can cause the controller 256 to set a flow rate of the cryogen 236, and then the user input device 266 on the cryotherapy applicator 232 and/or the foot pedal 267 can be used to start the flow of the cryogen 236 at the flow rate that was set using the base-station input device 270.
In some examples, the base-station input device 270 can additionally or alternatively indicate to the controller 256 an amount of time for which the cryogen 236 will flow during a treatment. For instance, the controller 256 can implement a timer that the controller 256 can use to make a determination that the cryogen 236 has been supplied to the end-effector 262 for the amount of time indicated by the base-station input device 270 and, responsive to the determination, automatically stop supplying the cryogen 236 to the end-effector 262. This can help a medical practitioner to control an amount of thermal energy applied to the target tissue.
As shown in
In some examples, the output device 272 can output data relating to personal information for a patient. For instance, the personal information can include at least one item of information selected from a group including: a name of the patient, a birthdate of the patient, an age of the patient, a gender of the patient, a height of the patient, a weight of the patient, a body temperature of the patient, a heart rate of the patient, a blood pressure of the patient, and an oxygen level of the patient. Outputting this information via the output device 272 can efficiently and conveniently provide the medical practitioner with information that can be used to set operational parameters (e.g., the rate of flow and/or a timer duration) and/or confirm operational parameters of the cryotherapy system 200 for a given cryotherapy treatment.
In some examples, the output device 272 can additionally or alternatively output data relating to procedure information. For instance, the procedure information can include at least one item of information selected from a group including: a type of procedure, an identification of a type of target tissue (e.g., a type of nerve), and a disorder to be treated. Outputting this information via the output device 272 can also efficiently and conveniently provide the medical practitioner with information that can be used to set operational parameters (e.g., the rate of flow and/or a timer duration) and/or confirm operational parameters of the cryotherapy system 200 for a given cryotherapy treatment.
In some examples, the output device 272 can additionally or alternatively output data relating to a status of the cryotherapy system 200. For instance, the output device 272 can output data relating to at least one item of information selected from a group including: (i) an indication that the cryogen 236 is flowing from the base station 230 to the end-effector 262, (ii) an indication that the cryogen is not flowing from the base station 230 to the end-effector 262, (iii) a flow rate of the cryogen 236 flowing from the base station 230 to the end-effector 262 (e.g., a value expressed in terms of units of volume per unit of time), (iv) a timer indicating a time that has elapsed since the cryogen 236 started flowing from the base station 230 to the end-effector 262, and (v) a timer indicating a time remaining until the flow of the cryogen 236 will be stopped. This information can provide feedback to the medical practitioner that can help to perform the cryotherapy treatment.
In some examples, the output device 272 can additionally or alternatively output data that is based on information determined by one or more sensors 274 of the cryotherapy system 200. As shown in
In this arrangement, the one or more sensors 274 can be configured to sense a condition and transmit to the controller 256 a sensor signal indicative of the condition sensed by the one or more sensors 274. The controller 256 can receive the sensor signal and, based on the sensor signal, responsively perform one or more actions such as, for instance, displaying information based on the sensor signal (e.g., displaying a temperature, a flow rate, and/or a pressure sensed by the sensor(s) 274), and/or operating the cryogen flow assembly 254 and/or the cryogen flow system 264 of the cryotherapy system 200 based on the sensor signal.
In some examples, the one or more sensors 274 can include a temperature sensor that can sense a temperature that is indicative of a temperature of the cryogen 236 in the canister 242. In some instances, the temperature of the cryogen 236 can affect the flow rate of the cryogen 236. In some implementations, the output device 272 can output an indication of the temperature of the cryogen 236 based on the temperature sensed by the temperature sensor.
In some implementations, the controller 256 can additionally or alternatively take an action to adjust a temperature of the cryogen 236 in the canister 242. For instance, as shown in
In this arrangement, the controller 256 can be configured to, based on the sensor signal, cause the heater 273 to increase the temperature of the canister 242 of the canister receptacle 240. In one example, the controller 256 can perform a comparison of the temperature sensed by the temperature sensor to a threshold temperature and, based on the comparison, determine that the temperature sensed by the temperature sensor is less than the threshold temperature. Responsive to determining that the temperature sensed by the temperature sensor is less than the threshold temperature, the controller 256 can cause the heater 273 to increase the temperature of the canister 242 until the controller 256 determines that the temperature sensed by the temperature sensor is at or above the threshold temperature.
In some examples, the one or more sensors 274 can include a temperature sensor located on an exterior of the shaft 260 at a location that is proximal to the end-effector 262. For instance, the temperature sensor located on the exterior of the shaft 260 and proximal to the end-effector 262 can help to determine if a cryogenic cooling treatment has expanded outside of a desired target area. For instance, if the temperature sensor senses a temperature below a threshold temperature, it may be indicative that the cryotherapy system 200 should cease supplying the cryogen 236 to the end-effector 262.
In one implementation, the controller 256 can perform a comparison of the temperature sensed by the temperature sensor to the threshold temperature and, based on the comparison, determine that the temperature sensed by the temperature sensor is less than the threshold temperature. Responsive to determining that the temperature sensed by the temperature sensor is less than the threshold temperature, the controller 256 can cause the output device 272 to provide an alarm in the form of an audio output and/or a visual output to indicate to the medical practitioner that the supply of the cryogen 236 should be stopped.
In some implementations, the controller 256 can be additionally or alternatively configured to automatically stop a supply and/or reduce a flow rate of the cryogen 236 to the end-effector 262 responsive to the temperature sensor sensing that the temperature is below the threshold temperature. For instance, responsive to the controller 256 determining that the temperature sensed by the temperature sensor is less than the threshold temperature, the controller 256 can automatically cause the cryogen flow assembly 254 of the base station 230 and/or the cryogen flow system 264 of the cryotherapy applicator 232 to stop supplying the cryogen 236 to the end-effector 262 and/or reduce a flow rate of the cryogen 236 to the end-effector 262.
In some examples, the one or more sensors 274 can include a temperature sensor located in an interior of the shaft 260 at a location that is proximal to the end-effector 262, and/or a temperature sensor located in an interior space of the end-effector 262 (e.g., in an interior space of a balloon of the end-effector 262). For instance, the temperature sensor(s) at these locations can sense a temperature that can be indicative of whether the cryogen 236 is being fully converted from a liquid phase to a gas phase.
In one implementation, the controller 256 can perform a comparison of the temperature sensed by the temperature sensor to the threshold temperature and, based on the comparison, determine that the temperature sensed by the temperature sensor is less than the threshold temperature (e.g., approximately 88 degrees Celsius). Responsive to determining that the temperature sensed by the temperature sensor is less than the threshold temperature, the controller 256 can cause the output device 272 to provide an alarm in the form of an audio output and/or a visual output to indicate to the medical practitioner that the cryogen 236 is not being fully converted from the liquid phase to the gas phase.
In some implementations, the controller 256 can be additionally or alternatively configured to automatically stop a supply and/or reduce a flow rate of the cryogen 236 to the end-effector 262 responsive to the temperature sensor sensing that the temperature is below the threshold temperature. For instance, responsive to the controller 256 determining that the temperature sensed by the temperature sensor is less than the threshold temperature, the controller 256 can automatically cause the cryogen flow assembly 254 of the base station 230 and/or the cryogen flow system 264 of the cryotherapy applicator 232 to stop supplying the cryogen 236 to the end-effector 262 and/or reduce a flow rate of the cryogen 236 to the end-effector 262.
In some examples, the one or more sensors 274 can include a temperature sensor located in an exterior surface of the end-effector 262 (e.g., on a treatment side of the end-effector 262 that is placed into contact with the target tissue during a cryotherapy procedure). In an example, the temperature sensor located on the exterior surface of the end-effector 262 can measure a temperature that can be indicative of an effectiveness of the cryotherapy procedure. For instance, the temperature sensed by the temperature sensor can indicate when the target tissue has reached a desired temperature.
In one implementation, the controller 256 can perform a comparison of the temperature sensed by the temperature sensor to a threshold temperature and, based on the comparison, determine that the temperature sensed by the temperature sensor is less than the threshold temperature. The threshold temperature can be a fixed value stored in the memory of the controller 256, or a variable value that is set by a user using the base-station input device 270. Responsive to determining that the temperature sensed by the temperature sensor is approximately equal to the threshold temperature, the controller 256 can cause the output device 272 to provide audio output and/or a visual output to indicate to the medical practitioner that the cryogen 236 that the target tissue has reached the threshold temperature.
In some implementations, the controller 256 can be additionally or alternatively configured to automatically stop a supply and/or reduce a flow rate of the cryogen 236 to the end-effector 262 responsive to the temperature sensor sensing that the temperature is below the threshold temperature. For instance, responsive to the controller 256 determining that the temperature sensed by the temperature sensor is less than the threshold temperature, the controller 256 can automatically cause the cryogen flow assembly 254 of the base station 230 and/or the cryogen flow system 264 of the cryotherapy applicator 232 to stop supplying the cryogen 236 to the end-effector 262 and/or reduce a flow rate of the cryogen 236 to the end-effector 262.
In some implementations in which the cryotherapy applicator 232 includes the temperature sensor on the shaft 260, in the shaft 260, and/or in the end-effector 262, the controller 256 can additionally or alternatively actuate a heater 275 on the shaft 260, in the shaft 260, and/or in the end-effector 262 of the cryotherapy applicator 232. As an example, the heater 275 can include an electric resistive heating device that can transduce electrical energy into thermal energy for heating the shaft 260 and/or the end effector 262. In this arrangement, the controller 256 can be configured to, based on the sensor signal, cause the heater 275 to increase the temperature of the shat 260 and/or the end-effector 262. In one example, the controller 256 can perform a comparison of the temperature sensed by the temperature sensor to a threshold temperature and, based on the comparison, determine that the temperature sensed by the temperature sensor is less than the threshold temperature. Responsive to determining that the temperature sensed by the temperature sensor is less than the threshold temperature, the controller 256 can cause the heater 275 to increase the temperature of the shaft 260 and/or the end-effector 262 until the controller 256 determines that the temperature sensed by the temperature sensor is at or above the threshold temperature.
In some examples, the one or more sensors 274 can be additionally or alternatively configured to sense an amount of the cryogen 236 that is in the canister 242, which is coupled to the canister receptacle 240. For example, the one or more sensors 274 can include a weight sensor that is configured to sense a weight of the canister 242 in the canister receptacle 240 and, based on the weight sensed by the weight sensor, the controller 256 can determine the amount of the cryogen 236 in the canister 242. In another example, the one or more sensors 274 can include a flow rate sensor that can sense a flow rate of the cryogen 236 and, based on the sensed flow rate over a period of time during which the flow rate was sensed, the controller 256 can determine the amount of the cryogen 236 in the canister 242. The output device 272 can be configured to output an indication of the amount of the cryogen 236 in the canister 242 sensed by the one or more sensor(s). This can help the medical practitioner to understand whether the amount of cryogen 236 in the canister 242 is great enough to perform a next cryotherapy procedure.
In one implementation, the controller 256 can perform a comparison of the amount of the cryogen 236 sensed by the one or more sensors 274 with a threshold amount, which is related to an amount of the cryogen 236 that is needed to perform a next cryotherapy procedure. Based on the comparison, the controller 256 can determine that the sensed amount of the cryogen 236 is less than the threshold amount of the cryogen 236. Responsive to determining that the sensed amount of the cryogen 236 is less than the threshold amount, the controller 256 can disable the cryogen flow assembly 254 and/or the cryogen flow system 264 such that a cryotherapy procedure cannot be started until the one or more sensors 274 sense an amount of the cryogen 236 that is greater than the threshold amount (e.g., after another canister 242 is coupled to the canister receptacle 240). This can help to avoid a scenario where a cryotherapy procedure is started without a sufficient amount of the cryogen 236 to complete the cryotherapy procedure.
In some examples, the one or more sensors 274 can be additionally or alternatively configured to sense a pressure of the cryogen 236 in the canister 242, which is coupled to the canister receptacle 240. For example, the one or more sensors 274 can include a pressure sensor that can sense a pressure of the cryogen 236 at or near an interface between the canister 242 and the cryogen flow assembly 254. In some instances, the pressure of the cryogen 236 can affect the flow rate of the cryogen 236. In some implementations, the output device 272 can output an indication of the pressure of the cryogen 236 based on the pressure sensed by the pressure sensor.
In some examples, the one or more sensors 274 can additionally or alternatively include a sensor that can determine information relating to the canister 242 that is coupled to the canister receptacle 240. For example, the canister 242 can include a data storage device (e.g., a non-transitory computer readable medium such as a radiofrequency identification (RFID) tag, and/or an erasable programmable read-only memory (EPROM) chip) and the one or more sensors 274 can include a reader device (e.g., a RFID reader and/or an EPROM reader) that can read information from the data storage device of the canister 242 to determine at least one item of information selected from a group including: (i) a type of the cryogen 236 in the canister 242, (ii) a size of the canister 242, (iii) a shape of the canister 242, (iv) a manufacturer of the canister 242, (v) an amount of the cryogen 236 in the canister 242, and (v) a number of times the cartridge 242 has used.
In another example, the one or more sensors 274 can include a first set of contacts (e.g., mechanical and/or electrical contacts), and the canister 242 can include a second set of contacts (e.g., mechanical and/or electrical contacts) that can engage the first set of contacts when the canister 242 is received in the canister receptacle 240. For instance, the information can be encoded to different arrangements of the second contacts such that different canisters 242 having different information can have different arrangements of the second contacts. Based on the engagement between the contacts, the one or more sensors 274 can determine the information relating to the canister 242.
In some examples, the output device 272 can provide an output to the medical practitioner including the information relating to the canister 242 described above. In some examples, the controller 256 can additionally or alternatively use the information relating to the canister 242 to control operation of the base station 230 (e.g., to perform the comparison of the amount of cryogen 236 to the threshold value as described above).
In some examples, the one or more sensors 274 can additionally or alternatively include an ultrasonic Doppler flow sensor and/or an optical Doppler flow sensor at a distal portion of the shaft 260. The ultrasonic Doppler flow sensor and/or an optical Doppler flow sensor can be used to locate an artery associated with a target tissue. In one example, the artery associated with the target tissue can include at least one nasal nerve and/or an artery from a sphenopalatine branch. In an implementation, the controller 256 can receive the sensor signal from the ultrasonic Doppler flow sensor and/or an optical Doppler flow sensor and, based on the sensor signal, the controller 256 can cause the output device 272 to provide an audio output and/or a visual output that indicates that the end-effector 262 is positioned at the target tissue.
In some examples, the one or more sensors 274 can additionally or alternatively include an electrode sensor at a distal portion of the shaft 260 and/or on the end-effector 262. The electrode sensor can be used to determine that the end-effector 262 is positioned at the target tissue (e.g., at the target nerve), and/or confirm an effectiveness of ablation by determining a change in a physiological response to electrical stimulation, using the electrode sensor, before, during, and/or after ablation. In an implementation, the controller 256 can receive the sensor signal from the electrode sensor and, based on the sensor signal, the controller 256 can cause the output device 272 to provide an audio output and/or a visual output that indicates that the end-effector 262 is positioned at the target tissue (e.g., at the target nerve) and/or confirmation of the effectiveness of ablation.
Also, in an implementation, the electrode sensor can include one or more impedance-based sensors that can measure an impedance of a tissue. For instance, the electrode sensor can include one or more stimulation/response electrodes, and/or a polar electrode array that is configured to measure at least one of: complex impedance and conductivity. In one example, the electrode sensor can be configured to apply an electrical signal (e.g., a 300 mHz signal) and responsively determine, based on a electricla signal, an impedance value. The controller 256 can then receive the sensor signal and determine, based on the impedance value, whether the end-effector 262 is positioned at the target tissue (e.g., at the target nerve), and/or confirm an effectiveness of ablation by determining a change in a physiological response to electrical stimulation.
In some examples, the one or more sensors 274 can additionally or alternatively include a sensor that can determine information relating to the cryotherapy applicator 232 that is coupled to the canister receptacle 240. For example, the cryotherapy applicator 232 and/or the cryogen conduit 234 can include a data storage device (e.g., a non- transitory computer readable medium such as a RFID tag and/or an EPROM chip) and the one or more sensors 274 can include a reader device (e.g., a RFID reader and/or an EPROM reader) that the RFID reader can read information from the data storage device to determine at least one item of information selected from a group including: (i) a size of the cryotherapy applicator 232, (ii) a shape of the cryotherapy applicator 232, and (iii) a manufacturer of the cryotherapy applicator 232. In another example, the one or more sensors 274 and/or the cryotherapy applicator 232 can include the first set of contacts and the second set of contacts, respectively, in a manner similar to that described above with respect to the canister 242. Within examples, the output device 272 can provide an output to the medical practitioner including the information relating to the cryotherapy applicator 232 described above.
As noted above, in some examples, the cryotherapy system 200 can be configured such that the base station 230 can be coupled with a plurality of different cryotherapy applicators 232. In such examples, the cryotherapy system 200 can include the cryotherapy applicator 232 and one or more additional cryotherapy applicators, where at least one of the one or more additional cryotherapy applicators is different from the cryotherapy applicator in at least one of a size or a shape. In such examples, it can be beneficial to indicate, using the output device 272, to the medical practitioner the type of cryotherapy applicator 232 that is coupled to the base station 230. In other examples, the controller 256 can set one or more parameters (e.g., a flow rate of the cryogen 236, a timer for supplying the cryogen 236, an amount of the cryogen 236 to supply, and/or a temperature at which to maintain the canister 242 using the heater 273) for operating the base station 230 based on the information relating to cryotherapy applicator 232 determined using the one or more sensors 274.
In some examples, the controller 256 can use the information relating to the cryotherapy applicator 232 to prevent the cryotherapy applicator 232 from being used during more than one cryotherapy procedure. For instance, the reader device can be further configured to write usage information to the data storage device of the cryotherapy applicator 232 to indicate that the cryotherapy applicator 232 has been used during a first cryotherapy procedure. Prior to performing a second cryotherapy procedure, the reader device can read the usage information from the data storage device and, responsive to a determination that the usage information indicates the cryotherapy applicator 232 was previously used, the controller 256 can prevent the base station 230 from supplying the cryogen 236 for the second cryotherapy procedure.
In some examples, the cryogen 236 that is returned to the base station 230 can be exhausted through a vent to an environment external to the housing 238 of the base station 230. In other examples, the base station 230 can include a cryogen collection reservoir 275 that is configured to receive the cryogen 236 returned from the cryotherapy applicator 232 to the base station 230. The cryogen collection reservoir 275 can be removably coupled to the housing 238 such that the cryogen collection reservoir 275 can be emptied and/or replaced.
In one implementation that includes a cryogen collection reservoir 275, the one or more sensors 274 can be configured to determine when the cryogen collection reservoir 275 should be emptied and/or replaced. For instance, the one or more sensors 274 can sense when an amount of the cryogen 236 in the cryogen collection reservoir is equal to or greater than a threshold amount, and transmit a signal to the controller 256. Based on the signal, the controller 256 can make a determination that the amount of the cryogen 236 in the cryogen collection reservoir 275 is equal to or greater than the threshold amount. In response to the determination, the controller 256 can cause the output device 272 to provide an alarm in the form of an audio output and/or a visual output to indicate to the medical practitioner that the cryogen collection reservoir 275 should be emptied and/or replaced.
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In some implementations, the camera 276 can be removably coupled to the cryotherapy applicator 232. For example, the cryotherapy applicator 232 can include a mount 278 that is configured to couple the camera 276 to the cryotherapy applicator 232. As one example, the mount 278 can include a clip that couple the camera 276 to the shaft 260 by a friction-fit coupling. Removably coupling the camera 276 to the cryotherapy applicator 232 can facilitate reuse of the camera 276 in implementations in which other components of the cryotherapy applicator 232 are disposable. In other examples, the camera 276 can be permanently coupled to the cryotherapy applicator 232.
The camera 276 can be in communication with the controller 256. In this example, the output device 272 can include a display device that is communicatively coupled to the controller 256. In this arrangement, the camera 276 can communicate the image data to the controller 256, and the controller 256 can use the image data to cause the display device to display the image captured by the camera 276. This arrangement can provide a convenient way for the medical practitioner to view images of the patient's anatomy while navigating the end-effector 262 to the target tissue.
Additionally, in some examples, the base station 230 can include one or more components of the camera 276, which can help to reduce a size of a portion of the camera 276 that is inserted into the body cavity with the cryotherapy applicator 232. For instance, a power source of the camera 276 can be located in the base station 230.
In some examples, the cryotherapy system 200 can additionally or alternatively include one or more features that can enhance a lighting condition in the body cavity to help visualize the patient's anatomy with the camera 276. For instance, as shown in
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As noted above, the cryogen conduit 234 can supply the cryogen 236 from the base station 230 to the cryotherapy applicator 232. In some examples, the cryogen conduit 234 can also return the cryogen 236 from the end-effector 262 to the base station 230. For instance, in one example, the cryogen conduit 234 can include a first lumen for supplying the cryogen 236 from the base station 230 to the cryotherapy applicator 232, and a second lumen for returning the cryogen 236 from the cryotherapy applicator 232 to the base station 230. In one implementation, the first lumen and the second lumen can be coaxial with each other (e.g., the first lumen can be positioned in the second lumen, or the second lumen can be positioned in the first lumen). In another example, the first lumen and the second lumen can be in a side-by-side arrangement.
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As noted above, the base station 230 can be configured to couple to a plurality of cryotherapy applicators 232, where each cryotherapy applicator 232 is different from another cryotherapy applicator 232 with respect to at least one of a size or a shape of the cryotherapy applicator 232. In one example, the plurality of cryotherapy applicators 232 can each have a respective curved portion 260C that differs from another of the cryotherapy applicators 232 in an angle formed by the curved portion 260C between a distal portion of the shaft 260 (e.g., a portion between the distal end 260A and the curved portion 260C) and a proximal portion of the shaft 260 (e.g., a portion between the proximal end 260B and the curved portion 260C). In another example, the plurality of cryotherapy applicators 232 can additionally or alternatively each have a respective length of the shaft 260 between the proximal end 260B and the distal end 260A, where the respective lengths differ from each other. In another example, a size and/or a shape of the end-effector 262 of at least one of the cryotherapy applicators 232 can be different than a size and/or a shape of the end-effector 262 of a least another one of the cryotherapy applicators 232.
In some examples, the plurality of cryotherapy applicators 232 can be packaged and sold as a kit, where each cryotherapy applicator 232 in the kit differs from at least another cryotherapy applicator 232 in the kit with respect to at least one of: a size of the handle 258, a shape of the handle 258, a size of the shaft 260, a shape of the shaft 260, a size of the end-effector 262, a shape of the end-effector 262, and a type of end-effector 262 (e.g., a balloon-type end-effector 262, a plate-type end-effector 262, an omni-directional end-effector 262, and/or an end-effector 262 with an active surface and an inactive surface).
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In other examples, a distal portion of the camera shaft 892 can be movable relative to a proximal portion of the camera shaft 892 to facilitate adjusting the field of view of the camera 276 relative to the cryotherapy applicator 232. For instance, the camera shaft 892 can be malleable such that the user can manually adjust a position and/or an orientation of the camera 276 relative to the cryotherapy applicator 232 prior to inserting the cryotherapy applicator 232 and the camera 276 in the body cavity during the cryotherapy procedure. In another implementation, the distal portion of the camera shaft 892 can be movable relative to the proximal portion of the camera shaft 892 while the cryotherapy applicator 232 and the camera 276 are positioned in the body cavity. For instance, the camera 276 can include one or more pull wires that can be operated to move the distal portion of the camera shaft 892 relative to the proximal portion of the camera shaft 892 and, thus, adjust the field of view of the camera 276.
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Although the camera 276 is communicatively coupled to the controller 256 by the data connector 593 in
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The cryotherapy applicator includes (i) the handle that is configured to be gripped by a user during a cryotherapy procedure, wherein the handle has the proximal end and a distal end, (ii) a shaft extending from the distal end of the handle, and (iii) an end-effector coupled to the shaft, wherein the end-effector is configured to use the cryogen to ablate a target tissue.
At block 1014, the process 1000 includes, while the cryogen conduit couples the cryotherapy applicator to the base station, moving an entirety of the cryotherapy applicator relative to an entirety of the base station to insert the end-effector in a body cavity and navigate the end-effector to the target tissue. The body cavity includes a cavity in an ear, a nose, or a throat. At block 1016, the process 1000 includes, after navigating the end-effector to the target tissue, supplying the cryogen from the canister in the base station to the end-effector to ablate the target tissue.
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The description of the different advantageous arrangements has been presented for purposes of illustration and description, and is not intended to be exhaustive or limited to the embodiments in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art. Further, different advantageous embodiments may describe different advantages as compared to other advantageous embodiments. The embodiment or embodiments selected are chosen and described in order to explain the principles of the embodiments, the practical application, and to enable others of ordinary skill in the art to understand the disclosure for various embodiments with various modifications as are suited to the particular use contemplated.
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In some instances, components of the devices and/or systems described herein may be configured to perform the functions such that the components are actually configured and structured (with hardware and/or software) to enable such performance. Example configurations then include one or more processors executing instructions to cause the system to perform the functions. Similarly, components of the devices and/or systems may be configured so as to be arranged or adapted to, capable of, or suited for performing the functions, such as when operated in a specific manner.
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Also, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein. Likewise, reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms “a,” “and,” “said,” and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. Unless defined otherwise herein, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
The breadth of the present application is not to be limited by the subject specification, but rather only by the plain meaning of the claim terms employed.
The present application claims the benefit of U.S. Provisional Application No. 63/084,418 filed on Sep. 28, 2020, the contents of which is hereby incorporated by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2021/052355 | 9/28/2021 | WO |
Number | Date | Country | |
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63084418 | Sep 2020 | US |