Devices and methods for treating ear, nose, and throat diseases

Abstract

This document discloses an apparatus and method for treating conditions such as rhinitis, wherein a distal end of a probe shaft is introduced through the nasal cavity, the distal end having an end effector having a first configuration with a low profile shaped to manipulate tissue within the nasal cavity. The distal end can be positioned near a nasal tissue region having at least one nasal nerve. Once properly positioned, the distal end can be reconfigured from the first configuration to a second configuration shaped to contact and follow the nasal tissue region, and at least one nasal nerve can subsequently be ablated via the distal end. Ablation can be performed using various mechanisms (e.g., cryotherapy) and optionally under direct visualization.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 872,195, filed July 9, 2019, the entire contents of which are hereby incorporated by reference. Technical Field

[0003] This disclosure relates to apparatus and methods for treating tissue regions. More specifically, the invention relates to apparatus and methods for treating tissue regions, for example, by cryotherapy, which includes cryocooling and cryoablation for treating ear, nose, and throat (ENT) diseases (e.g., rhinitis). Background Technology

[0004] Unless otherwise stated herein, the materials described in this section are not prior art for the purposes of the claims in this application, nor are they acknowledged as prior art by virtue of their inclusion in this section.

[0005] The human nose is responsible for heating, humidifying, and filtering inhaled air. It is primarily composed of cartilage, bone, mucous membranes, and skin. The left and right nasal cavities extend posteriorly to the soft palate, where they merge to form the posterior nasal openings. These openings connect to the nasopharynx. The roof of the nose is partially formed by a bone called the cribriform plate. The cribriform plate contains numerous tiny perforations through which sensory nerve fibers extend to the olfactory bulb. The sense of smell occurs when inhaled odors come into contact with a small area of ​​the mucous membrane in the upper part of the nose, stimulating the nerve fibers leading to the olfactory bulb.

[0006] The nasal turbinates are three bony protuberances extending medially from the lateral walls of the nose and covered by a sheet of mucous membrane. These turbinates increase the internal surface area of ​​the nose and provide warmth and moisture to the air inhaled through the nose. The sheet of mucous membrane covering the turbinates can become congested and swollen or become essentially devascularized and contract in response to changes in physiological or environmental conditions. The curved edges of each turbinate define passages called nasal meatuses. For example, the inferior nasal meatus is the passage that passes beneath the inferior turbinate. A duct called the nasolacrimal duct drains tears from the eye into the nose through an opening located within the inferior nasal meatus. The middle nasal meatus is the passage located lateral to the middle turbinate and below its attachment to the lateral wall. The middle nasal meatus contains the semilunar hiatus, in which the opening or orifice connects to the maxillary sinus, frontal sinus, and anterior ethmoid sinus. The superior nasal meatus lies between the superior and middle turbinates.

[0007] The nasal turbinates are autonomously innervated by nerves originating from the pterygopalatine canal. The pterygopalatine canal contains both sympathetic and parasympathetic afferents, modulating the function of the soft tissues covering the turbinates to increase (parasympathetic) or decrease (sympathetic) activity in the submucosa. The pterygopalatine canal reaches the sphenopalatine ganglion via the pterygopalatine foramen (SPF). Some fibers of the SPG enter the nasal cavity through the SPF. In addition to the SPF, extra posterolateral neurovascular branches extend from the SPG to supply the nasal mucosa. These branches are most commonly located within 1 cm posterosuperior to the horizontal appendage of the inferior turbinate, and within 5 mm anteroinferior to this appendage, approaching the palatine bone through a foramen distinct from the SPF. In some cases, interfascicular anastomoses are associated with at least three accessory nerves. Each accessory nerve may run directly along the SPG or the greater palatine nerve.

[0008] Rhinitis is defined as an inflammation of the nasal mucosa, characterized by nasal symptoms including itching, runny nose, and / or nasal congestion. Chronic rhinitis affects millions of people and is a leading cause of medical care. Drug treatments have proven to be limited in their effectiveness for patients with chronic rhinitis, often requiring daily medication or arduous allergy treatments, and up to 20% of patients may be difficult to treat.

[0009] Besides existing medications, turbinate repositioning procedures (e.g., radiofrequency-based and microdebridement-based procedures) have been shown to have a temporary effectiveness of 1-2 years and can lead to complications including mucosal flap detachment, severe pain and swelling, overtreatment, and bone damage. Furthermore, turbinate repositioning does not treat runny nose symptoms.

[0010] It is believed that the parasympathetic function of the pterygopalatine canal nerve primarily controls autonomic balance, and therefore transection of it may lead to a reduction in rhinitis and nasal congestion. This pathophysiology has been confirmed, and surgical treatment of the pterygopalatine canal nerve has indeed shown a reduction in some rhinitis symptoms; however, the surgery is invasive, time-consuming, and can lead to chronic dry eye because the autonomic nerve fibers in the pterygopalatine canal nerve also supply the lacrimal glands.

[0011] Hyperthermia may represent a solution to the aforementioned limitations of prior treatments for ear, nose, and throat conditions such as rhinitis. These therapies treat tissue by inducing temperature changes that selectively produce tissue alterations, sometimes causing temporary or permanent damage. Depending on the type of tissue and body area targeted for treatment, the application of thermal energy can offer a variety of benefits, including treating arrhythmias, destroying cancerous tissue masses, and altering neural signaling pathways. Tissue ablation refers to a class of hyperthermic therapies that cause destructive tissue damage. This damage can be induced by applying heat (e.g., using radiofrequency, laser, microwave, high-intensity focused ultrasound (HIFU), or resistance heating methods) or by applying cooling energy (e.g., using cryoablation).

[0012] The term "cryotherapy" describes a class of thermotherapy involving inducing cold or low temperatures in body tissues, and includes therapies commonly referred to as cryotherapy and cryoablation. Depending on the temperature involved and the duration of exposure, the clinical goals of various cryotherapies can range from improved tissue healing / recovery (e.g., as with cryotherapy used during physical therapy) to selective tissue damage or destruction (e.g., during cryoablation used for neuromodulation or tumor destruction). Any tissue damage induced during cryotherapy may be temporary or permanent, depending on the tissue treated and the characteristics of the therapy performed.

[0013] In recent years, various cryotherapy techniques have been accepted for use in ear, nose, and throat (ENT) surgery. Applications include the treatment of rhinitis, turbinate hypertrophy, and other clinicopathologies. Modern cryotherapy in ENT is typically performed using a compressed cryogenic liquid (such as nitrous oxide) that expands into a gas during a transition to atmospheric pressure to provide a cooling source. This method of providing cryotherapy eliminates the need for the complex systems typically associated with thermoelectric / Peltier effect cooling and circulating fluid-based cooling, such as pumps, wiring, and / or other electrical hardware.

[0014] With the increasing popularity of cryotherapy in the ENT field in recent years, the devices, systems, and methods used for performing cryotherapy in the ENT have also been developed and improved. Some advancements in devices and technologies are aimed at improving medical outcomes, while others are related to commercial or practical goals. For example, ENT surgery is increasingly being performed in outpatient office-based facilities, where the devices and technologies used may differ significantly from those considered practical and safe in hospitals. However, even with these latest technological advancements, some limitations still exist in the most advanced cryotherapy devices available.

[0015] Therefore, if the existing limitations known to those skilled in the art can be addressed with practical and cost-effective solutions, the application of cryotherapy in otolaryngology will be meaningfully improved. Continued improvement of cryotherapy and other hyperthermic devices and techniques will enable more physicians to perform surgery, allow more patients to undergo surgery, and enable patients undergoing surgery to experience better outcomes. Summary of the Invention

[0016] This disclosure relates to systems, apparatus, and methods for delivering cryotherapy interventions. More specifically, this disclosure relates to providing cryotherapy interventions for ear, nose, and throat diseases. This disclosure will be particularly useful when treating patients during outpatient surgery or in other situations where general anesthesia is unavailable, impractical, and / or undesirable. This disclosure will be particularly useful during the administration of cryotherapy to the upper airway.

[0017] This disclosure provides methods, devices, and systems for facilitating cryotherapy delivery by leveraging solutions that improve the balance between simplicity, usability, and effectiveness. More specifically, the systems, devices, and / or methods of this disclosure allow for the improved delivery of cryotherapy into the nasal cavity or other body cavities. Doing so is valuable because it will improve the patient experience when receiving these important treatments, which could encourage more patients to choose to receive them.

[0018] In one example, this disclosure provides a device. The device includes a probe shaft having a distal end and a proximal end. The probe shaft has a curved portion such that the longitudinal axis of the distal portion of the probe shaft has a non-zero angle relative to the longitudinal axis of the proximal portion of the probe shaft. The flexibility of the distal portion of the probe shaft is greater than that of the proximal portion. The device also includes a housing coupled to the proximal end of the probe shaft and a handle coupled to the housing. The device also includes an end effector coupled to the distal end of the probe shaft. When the distal end of the probe shaft is advanced through a patient's nasal cavity and positioned near a nasal tissue region having at least one nasal nerve, the end effector defines a trauma-resistant surface and is configured to transmit lateral pressure onto the nasal tissue region. The device also includes a trigger positioned in the handle. When the end effector contacts the nasal tissue region, actuation of the trigger causes the end effector to ablate at least one nasal nerve.

[0019] In another example, this disclosure provides another device. The device includes a probe shaft having a distal end and a proximal end. The probe shaft has a curved portion positioned between the distal and proximal portions of the probe shaft, such that the longitudinal axis of the distal portion of the probe shaft has a non-zero angle relative to the longitudinal axis of the proximal portion of the probe shaft. The proximal portion of the probe shaft includes a first tube having a first diameter and a second tube having a second diameter greater than the first diameter, such that an air gap separates the first and second tubes. The device also includes a housing coupled to the proximal end of the probe shaft and a handle coupled to the housing. The device also includes an end effector coupled to the distal end of the probe shaft. When the distal end of the probe shaft is advanced through a patient's nasal cavity and positioned near a nasal tissue region having at least one nasal nerve, the end effector defines a trauma-resistant surface. The end effector is configured to transmit lateral pressure onto the nasal tissue region. The device also includes a trigger positioned in the handle. When the end effector contacts the nasal tissue region, actuation of the trigger causes the end effector to ablate at least one nasal nerve.

[0020] In another example, this disclosure provides a method for treating a nasal tissue region of a patient's nasal cavity. The method includes introducing a distal end of a probe shaft through the nasal cavity. The distal end of the probe shaft has an end effector having a first configuration with a low profile shaped to manipulate tissue within the nasal cavity. The probe shaft has a curved portion such that the longitudinal axis of the distal portion of the probe shaft has a non-zero angle relative to the longitudinal axis of the proximal portion of the probe shaft. The flexibility of the distal portion of the probe shaft is greater than that of the proximal portion. The method further includes reconfiguring the end effector from the first configuration to a second configuration, wherein the end effector is shaped to contact and follow the contour of the nasal tissue region. The method also includes ablating at least one nasal nerve in the nasal tissue region via the end effector.

[0021] These and other aspects, advantages, and alternatives will become apparent to those skilled in the art upon reading the following detailed description (with reference to the accompanying drawings where appropriate). Attached Figure Description

[0022] Figure 1 This is an internal lateral view of the nasal cavity, showing the target area of ​​the lateral nasal wall and the relevant nasal anatomy and nerves in and around that target area.

[0023] Figure 2 It is a perspective view based on an example device.

[0024] Figure 3 It is based on an example Figure 2 Top view of the device shown.

[0025] Figure 4 It is based on an example Figure 2 Top view of the far end of the device shown.

[0026] Figure 5 It is based on an example Figure 2 A side view of an exemplary cryogenic fluid source for the apparatus shown.

[0027] Figure 6 It is based on an example Figure 2 Side view of the device shown.

[0028] Figure 7 It is based on an example Figure 2 A perspective cross-sectional view of the device shown.

[0029] Figure 8 It is based on an example Figure 2 A side cross-sectional view of the trigger of the device shown.

[0030] Figure 9 It is based on an example Figure 2The device shown is viewed from below.

[0031] Figure 10A This is a side view of the expandable and planar components of an example end effector in a collapsed configuration, based on an example.

[0032] Figure 10B This is a side view of the expandable member and planar member of an example end actuator in an expandable configuration, according to an example.

[0033] Figure 11 It is based on an example Figure 2 A perspective view of the distal end of the probe shaft of the device shown.

[0034] Figure 12A It is based on an example Figure 2 The diagram shows a perspective view of a device that includes a temperature sensor.

[0035] Figure 12B It is based on another example. Figure 2 The diagram shows a perspective view of a device that includes a temperature sensor.

[0036] Figure 12C It is based on another example. Figure 2 The diagram shows a perspective view of a device that includes a temperature sensor.

[0037] Figure 12D It is based on another example. Figure 2 The diagram shows a perspective view of a device that includes a temperature sensor.

[0038] Figure 13 It is based on an example Figure 2 The diagram shows a perspective view of the device, which includes a camera and a light source.

[0039] Figure 14 It is based on an example Figure 2 The diagram shows a perspective view of a device that includes a Doppler sensor.

[0040] Figure 15 It is based on an example Figure 2 The diagram shows a perspective view of a device that includes electrodes. Detailed Implementation

[0041] This document describes exemplary methods and systems. It should be understood that the terms “exemplary,” “illustrative,” and “illustrative” are used herein to mean “serving as an example, instance, or illustration.” Any example or feature described herein as “exemplary,” “illustrative,” or “illustrative” is not necessarily to be construed as superior to or more advantageous than other examples or features. The examples described herein are not intended to be limiting. It will be readily understood that various aspects of the invention, as generally described and illustrated herein, can be arranged, substituted, combined, separated, and designed in a variety of different configurations, all of which are expressly contemplated herein.

[0042] Furthermore, the specific arrangement shown in the figures should not be considered limiting. It should be understood that other examples may include more or fewer elements in each of the given elements shown in the figures. Additionally, some elements shown may be combined or omitted. Furthermore, examples may include elements not shown in the figures.

[0043] In the following description, numerous specific details are set forth to provide a thorough understanding of the disclosed concepts, which can be implemented without some or all of these details. In other instances, details of known devices and / or processes have been omitted to avoid unnecessarily obscuring the invention. While some concepts will be described in conjunction with specific examples, it will be understood that these examples are not intended to be limiting.

[0044] Unless otherwise stated, the terms “first,” “second,” etc., are used merely as labels in this document and are not intended to impose any order, position, or hierarchy on the things referred to by these terms. Furthermore, references to something as “second” do not require or preclude the existence of something as “first” or lesser-numbered and / or something as “third” or greater-numbered.

[0045] As used herein, a system, device, structure, article, element, component, or hardware "configured" to perform a specified function is actually capable of performing the specified function without any changes, rather than merely having the possibility of performing the specified function after further modification. In other words, a system, device, structure, article, element, component, or hardware "configured" to perform a specified function is specifically selected, created, implemented, utilized, programmed, and / or designed for the purpose of performing the specified function. As used herein, "configured" indicates existing features of the system, device, structure, article, element, component, or hardware that enable the system, device, structure, article, element, component, or hardware to perform the specified function without further modification. For the purposes of this disclosure, a system, device, structure, article, element, component, or hardware described as "configured" to perform a particular function may additionally or alternatively be described as "suitable" and / or "operational to" perform that function.

[0046] The limitation of the appended claims is not written in the format of “means + function” and is not intended to be interpreted based on 35 U.S.C. 112(f) unless, and until such limitation of claims expressly uses the phrase “means for…” and then indicates the function in the absence of any other structure.

[0047] Referring to the quantities or measurements described herein, the terms “about,” “approximately,” or “substantially” mean that the exact nature, parameter, or value is not required, but rather that deviations or variations in amount may occur (including, for example, tolerances, measurement errors, limitations on measurement accuracy, and other factors known to those skilled in the art), which do not preclude the effects that the characteristic is intended to provide.

[0048] The following provides illustrative, non-exclusive examples of the subject matter that may or may not be claimed under this disclosure.

[0049] This disclosure relates to systems, apparatus, and methods for applying cryotherapy. More specifically, this disclosure relates to the application of cryotherapy in relation to ear, nose, and throat diseases. The apparatus and methods described herein are particularly useful when delivering treatment to patients in an office-based environment. Using the disclosed methods, apparatus, and systems allows for improved cryotherapy with greater utility and practicality compared to existing devices and techniques.

[0050] The various aspects of this disclosure described herein can be applied to any specific application described below or to any other type of hyperthermic or non-thermal system or method. This disclosure can be applied as a standalone system or method, or as part of an integrated medical system.

[0051] Generally speaking, this disclosure aims to improve at least some aspects of existing cryotherapy devices. These improvements can achieve better results, more practical uses, and ultimately benefit patients and caregivers.

[0052] Refer to the attached diagram. Figure 1 This is an internal view of the nasal cavity, showing some relevant nasal anatomy. The orientation shown includes the lateral nasal wall 4, nose 1, nostril 2, and upper lip 3. The superior turbinate 5, middle turbinate 6, and inferior turbinate 7 are depicted, along with related nerves shown in dashed lines. The posterior nasal nerves 10, 11, and 12 provide parasympathetic control of the nasal mucosa, which comprises a mucosal sheet covering the turbinates. These posterior nasal nerves (PNNs) originate from the sphenopalatine ganglion. Sometimes, other accessory posterior nasal nerves (APNNs) may originate from the palatine canal or from the bony plate beneath the mucosal sheet.

[0053] Figure 2 This is a schematic diagram of device 100, configured to treat a nasal tissue region having at least one nasal nerve, for the treatment of rhinitis and / or other conditions. Figure 2 As shown, the device 100 includes a probe shaft 102 having a distal end 104 and a proximal end 106. (As in...) Figure 3 As shown in the top view of the device 100, the probe shaft 102 has a curved portion 108 such that the longitudinal axis 110 of the distal portion 112 of the probe shaft 102 forms a non-zero angle 114 with the longitudinal axis 116 of the proximal portion 118 of the probe shaft 102. The flexibility of the distal portion 112 of the probe shaft 102 may be greater than that of the proximal portion 118 of the probe shaft 102, as discussed in more detail below. For example, the length of the proximal portion 118 of the probe shaft 102 is at least two or at least three times the length of the distal portion 112 of the probe shaft 102. The distal portion 112 of the probe shaft 102 may extend from the distal end 104 of the probe shaft 102 to the curved portion 108. The proximal portion 118 of the probe shaft 102 may extend from the proximal end 106 of the probe shaft 102 to the curved portion 108.

[0054] like Figure 2 As shown, the device 100 also includes a housing 119 coupled to the proximal end 106 of the probe shaft 102 and a handle 120 coupled to the housing 119. The proximal end 106 of the probe shaft 102 may extend into the housing 119. In one example, as... Figure 2 As shown, the handle 120 includes a pistol grip, which includes a finger grip 125. Therefore, as... Figure 2 As shown, the device 100 can be configured to be held like a pistol by a surgical practitioner using the handle 120. Other arrangements of the handle 120 are also possible.

[0055] The device 100 also includes an end effector 122 coupled to the distal end 104 of the probe shaft 102. Typically, the end effector 122 is configured to ablate target tissue adjacent to the end effector 122. For example, the end effector 122 may be configured to ablate at least one nasal nerve using cryofluid (e.g., the end effector 122 may include a cryoablation element), radio frequency (RF) energy, microwave energy, ultrasonic energy, resistance heating, exothermic chemical reaction, or a combination thereof. Although the end effector 122 is described below as being used in one embodiment where it is configured to ablate the target tissue region using cryofluid, the end effector 122 may additionally or alternatively be configured to ablate the target tissue using one or more of the other ablation modalities described above. Furthermore, the end effector 122 is shown as having various variations described herein and may be interchangeable depending on the specific example used by the surgical practitioner.

[0056] When the distal end 104 of the probe shaft 102 is advanced through the patient's nasal cavity and positioned near a region of nasal tissue having at least one nasal nerve (e.g., a nasal nerve associated with the lateral nasal wall), the end effector 122 may define a trauma-resistant surface. For example, the trauma-resistant surface of the end effector 122 may have rounded edges and / or blunt edges, omitting sharp corners or acute edges. To help define the trauma-resistant surface, the end effector 122 may additionally or optionally be formed of a compliant material that conforms to the shape of the anatomical structures contacted by the end effector 122 as it passes through the nasal cavity. For example, the end effector 122 may be formed at least partially of at least one material selected from the group consisting of silicone rubber, polyurethane rubber, nylon, and / or polymeric materials (e.g., polyethylene terephthalate (PET)).

[0057] The end effector 122 is configured to transmit lateral pressure over the nasal tissue region once positioned therein. For example, the device 100 may be configured such that the surgical practitioner can press the end effector 122 against the lateral nasal wall near the target posterior nasal nerve. In some embodiments, the end effector 122 may be configured to conform to the morphology of the target tissue (e.g., the lateral nasal wall) and engage the target tissue (e.g., the lateral nasal wall) more uniformly with a substantially uniform contact pressure compared to an end effector 122 that does not conform to the morphology of the target tissue. This can help to effectively ablate the target tissue region in a relatively uniform manner, and thereby ablate the target tissue region in a more predictable and controllable manner to achieve the desired clinical outcome.

[0058] In one example, the probe shaft 102 may have a length of about 4 cm to about 10 cm and a diameter of about 1 mm to about 4 mm. In some examples, the outer diameter of the end effector 122 may be approximately equal to the diameter of the probe shaft 102. In other examples, the diameter of the end effector 122 may be greater than or less than the diameter of the probe shaft 102. Furthermore, in one example, the extended length of the end effector 122 may be about 0.5 cm to about 1.5 cm. The end effector 122 may be substantially flexible along its longitudinal axis (e.g., along axis 110); however, the end effector 122 may also be at least partially extendable by the user and configurable by the user for shaping. Shaping of the end effector 122 may be performed manually by the surgical practitioner. Various lengths, shapes, and diameters of the end effector 122 of the device 100 can be produced and supplied to the end user.

[0059] For example, the end effector 122 may be additionally or alternatively configured to deliver lateral pressure over the nasal tissue region based on at least one feature selected from a set of features, including: (i) the probe shaft 102 having a curved portion 108 such that the longitudinal axis 110 of the distal portion 112 of the probe shaft 102 forms a non-zero angle with the longitudinal axis 116 of the proximal portion 118 of the probe shaft 102; and (ii) the flexibility of the distal portion 112 of the probe shaft 102 is greater than the flexibility of the proximal portion 118 of the probe shaft 102.

[0060] For example, due to the curved portion 108, the proximal portion 118 of the probe shaft 102 allows the end effector 122 to contact and flatten against the area of ​​nasal tissue of interest, while the proximal portion 118 of the probe shaft 102 applies negligible pressure or no pressure on other anatomical features of the nasal cavity. Figure 3 As shown, the non-zero angle 114 between the longitudinal axis 110 of the distal portion 112 of the probe shaft 102 and the longitudinal axis 116 of the proximal portion 118 of the probe shaft 102 can be from about 15 degrees to about 25 degrees, and preferably about 20 degrees. This bend in the probe shaft 102 at the bend 108 can additionally or optionally facilitate the navigation of the end effector 122 through the nasal cavity and allow for improved operability around structures such as the middle and inferior turbinates.

[0061] In one embodiment of device 100, such as Figure 4 As shown, the curved portion 108 of the probe shaft 102 is positioned approximately 4 cm from the distal end of the end effector 122 of the probe shaft 102, and the curved portion 108 causes the distal end of the end effector 122 of the probe shaft 102 to be laterally offset approximately 1 cm relative to the longitudinal axis 116 of the proximal portion 118 of the probe shaft 102. It has been found that positioning the curved portion 108 of the probe shaft 102 approximately 4 cm from the distal end of the end effector 122 can advantageously aid in aiming the device 100 at the inferior turbinate. For surgical procedures targeting different tissue areas, the curved portion 108 can be positioned at different distances from the distal end of the end effector 122. Using examples of this disclosure, improved (or optimized) navigation capabilities have been created, and the ability to achieve adequate contact between the end effector 122 and key anatomical structures within the nasal cavity has been enhanced.

[0062] Furthermore, as described above, the flexibility of the distal portion 112 of the probe shaft 102 may be greater than that of the proximal portion 118 of the probe shaft 102. This difference in flexibility between the proximal portion 118 and the distal portion 112 of the probe shaft 102 can provide a flexural position of the probe shaft 102 at a location between the proximal and distal portions 112 (e.g., at the bend 108 of the probe shaft 102) when the end effector 122 engages the target tissue region. In embodiments where there is no difference in flexibility between the proximal and distal portions 118 and 112 of the probe shaft 102, the flexural position between the proximal and distal portions 112 can be located more proximally along the probe shaft 102 than the flexural position of the probe shaft 102. Compared to an embodiment where the probe axis 102 has substantially the same flexibility along its entire length, providing a more proximal flexure position along the probe axis 102 allows a relatively large portion (e.g., greater than 50%) or the entire tissue-facing surface of the end effector 122 to contact the surface of the target tissue (e.g., the lateral nasal wall) more uniformly when the surgeon manipulates the handle 120 in the direction toward the target tissue.

[0063] For example, to provide a flexibility difference between the proximal portion 118 and the distal portion 112 of the probe shaft 102, the proximal portion 118 and the distal portion 112 of the probe shaft 102 may (i) be formed of different materials and / or (ii) have different dimensions. For example, the proximal portion 118 may be formed of one or more rigid materials selected from: metal tubing (i.e., stainless steel tubing), polymer / plastic tubing (i.e., PEEK, nylon, ABS, polyurethane, polyethylene), and braided / woven tubing. The distal portion 112 may each be formed of one or more materials selected from: thermoplastic elastomers (e.g., polyether block amides also known as PEBAX), nylon, polyurethane, polyethylene, polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), laser-cut metal tubing, metal coiled material, and mesh / braided shaft material. Furthermore, for example, the one or more materials selected for the proximal portion 118 may be different from the one or more materials selected for the distal portion 112.

[0064] In one example, the flexibility of the distal portion 112 of the probe shaft 102 may be about two to about four times that of the proximal portion 118 of the probe shaft 102. In one embodiment, the distal portion 112 may have a corresponding hardness value selected from a range of values ​​between about 35 Shore D and about 72 Shore D.

[0065] Additionally, in one example, the distal portion 112 of the probe shaft 102 may have a corresponding stiffness and / or flexibility value, such that the force required to bend the distal portion 112 and the end effector 122 by approximately 22 degrees relative to the proximal portion 118 of the probe shaft may be from 0.3 lbs to approximately 0.7 lbs. In another example, the distal portion 112 of the probe shaft 102 may have a corresponding stiffness and / or flexibility value, such that the force required to bend the distal portion 112 and the end effector 122 by approximately 22 degrees relative to the proximal portion 118 of the probe shaft may be from approximately 0.6 lbs to approximately 0.7 lbs. In yet another example, the distal portion 112 of the probe shaft 102 may have a corresponding stiffness and / or flexibility value, such that the force required to bend the distal portion 112 and the end effector 122 by approximately 22 degrees relative to the proximal portion 118 of the probe shaft may be from approximately 0.3 lbs to approximately 0.5 lbs.

[0066] The probe shaft 102 can be configured to be rotatably coupled to the housing 119 of the device 100 to facilitate the positioning of the end effector 122 without excessive rotation of the device 100. In one example, the probe shaft 102 can be rotated 180 degrees relative to the housing 119 of the device 100. Thus, the non-zero angle 114 between the longitudinal axis 110 of the distal portion 112 of the probe shaft 102 and the longitudinal axis 116 of the proximal portion 118 of the probe shaft 102 can be adjusted from a leftward tilt when viewing the device 100 from a top view to a rightward tilt when viewing the device 100 from a top view. For example, during use, the surgeon can insert the end effector 122 of the device 100 and ablate the target nasal nerve in the patient's left nostril, remove the device from the patient's nasal cavity, rotate the probe shaft 102 180 degrees, then insert the end effector 122 of the device 100 and ablate the target nasal nerve in the patient's right nostril without altering the surgeon's grip on the handle 120.

[0067] In one particular example, the housing 119 of the device 100, located just near the proximal end 106 of the probe shaft 102, may include a pair of pawls and a corresponding pair of notches. The pawls may be positioned approximately 180 degrees apart, and the corresponding pair of notches may also be positioned approximately 180 degrees apart. In a first configuration (e.g., a configuration where the probe shaft 102 is tilted to the left when viewed from a top view of the device 100), the first pawl of the pair of pawls is positioned in the first notch of the pair of notches, and the second pawl of the pair of pawls is positioned in the second notch of the pair of notches. Once the probe shaft 102 is rotated, the pair of pawls may be configured to rotate relative to the pair of notches until the device 100 is in the second configuration. In the second configuration (e.g., a configuration where the probe shaft 102 is tilted to the right when viewed from a top view of the device 100), the first pawl is positioned in the second notch, and the second pawl is positioned in the first notch.

[0068] The device 100 also includes a trigger 124 positioned in a handle 120. When the end effector 122 contacts the nasal tissue region, actuation of the trigger 124 causes the end effector 122 to ablate at least one nasal nerve in the nasal tissue. As a non-limiting example, at least one nasal nerve in the nasal tissue region may include one or more posterior nasal nerves, nasal branches of the pterygopalatine canal nerve. In another example, the distal end 104 of the probe shaft 102 is advanced through the patient's nasal cavity and close to the sphenopalatine foramen. As described above, the flexibility difference between the proximal portion 118 and the distal portion 112 of the probe shaft 102 causes the flexural position of the probe shaft 102 to shift to a more proximal position on the device 100, thereby allowing the end effector 122 to rest against a flat surface such as the lateral nasal wall as described above. This flexibility difference, additionally or optionally, allows the device 100 to adapt to a wider range of anatomical structures without requiring the operator to apply undue large tissue forces to establish proper tissue contact.

[0069] As described above, the end effector 122 can be configured to ablate at least one nasal nerve using at least one ablation mode selected from a set of modes, including: cryofluid (e.g., cryoablation element), radiofrequency energy, microwave energy, ultrasound energy, resistance heating, exothermic chemical reaction, or combinations thereof. In one example, the device 100 includes a cryofluid source 126 at least partially positioned in a handle 120 and a lumen disposed in a probe shaft 102 and in fluid communication with the cryofluid source 126. In one example, the cryofluid source 126 can be supplied with liquid cryoprotectant and configured for use on a single patient.

[0070] Alternatively, the device 100 can be configured for use with a user-replaceable cryogenic fluid source 126, which is in the form of a can that is detachably and at least partially positioned in the handle 120. Figure 5 An example container of this type is shown. For example... Figure 5 As shown, the cryogenic fluid source 126 includes a cap 127 and a plurality of threads 129 configured to engage with a handle 120 (see Figure 120). Figure 7 Multiple threads 131 interact to detachably connect the cryogenic fluid source 126 to the device 100. In another alternative, a reservoir separate from the device 100 may be fluidly connected to the handle 120. In this example, the device 100 also includes a liquid refrigerant flow control valve (not shown) arranged in fluid communication with the lumen in the cryogenic fluid source 126 and the probe shaft 102.

[0071] Figure 6This is a side view of the device, showing the height 128 of the cryofluid source 126 relative to the longitudinal axis 116 of the proximal portion 118 of the probe shaft 102. In one example, the height 128 is less than about 2 cm. In another example, the height 128 can be about 0.5 inches (e.g., about 1.27 cm). This height allows all necessary device components (including the cryofluid source 126 and associated cryoline input features) to be properly positioned within the device 100 for adequate flow, while allowing the user sufficient grip space to rotate the cap of the cryofluid source 126 with sufficient torque to place / puncture the cryotherapy canister and subsequently remove it after treatment. The reduced height 128 provides several advantages for operator convenience and ultimately for the likelihood of surgical success, as it allows the operator to hold the device with one hand and simultaneously operate the endoscope (or other tools) with the other hand with minimal or no interference. More specifically, the reduced height 128 allows the secondary hand operating the endoscope or other tools to freely pass through the plane of the device hand when navigating the device 100 into the nasal cavity.

[0072] In addition, such as Figure 6 As shown, the device 100 includes an angle 130 between the longitudinal axis 132 of the cryogenic fluid source 126 and the longitudinal axis 116 of the proximal portion 118 of the probe shaft 102. For example, the angle 130 between the longitudinal axis 132 of the cryogenic fluid source 126 and the longitudinal axis 116 of the proximal portion 118 of the probe shaft 102 can be configured to allow cryogenic fluid to flow from the cryogenic fluid source 126 to the end effector 122 when the patient is sitting upright and when the patient is lying prone. In an exemplary embodiment, the angle 130 between the longitudinal axis 132 of the cryofluid source 126 and the longitudinal axis 116 of the proximal portion 118 of the probe axis 102 can vary between approximately 0 degrees and approximately 90 degrees, between approximately 10 degrees and approximately 90 degrees, between approximately 20 degrees and approximately 90 degrees, between approximately 30 degrees and approximately 90 degrees, between approximately 40 degrees and approximately 90 degrees, between approximately 50 degrees and approximately 90 degrees, between approximately 60 degrees and approximately 90 degrees, between approximately 60 degrees and approximately 100 degrees, and between approximately 70 degrees and approximately 90 degrees. In another embodiment, the angle 130 can be approximately 75 degrees to facilitate treatment of patients who are fully supine or fully seated. Furthermore, the approximately 75-degree relative angle between the longitudinal axis 132 of the cryofluid source 126 and the longitudinal axis 116 of the proximal portion 118 of the probe axis 102 also takes into account the position of the patient's head relative to the patient's body. Therefore, the currently disclosed design allows providers improved (or optimized) flexibility and freedom in treating patients in the largest number of locations.

[0073] refer to Figure 7The currently disclosed example of device 100 includes a trigger 124 that allows for simplified operation that can be reliably performed by a user using one hand or a single finger. As shown, the embodiment includes a trigger-type switching valve 134 that a user can grip to initiate the release of refrigerant through probe shaft 102 into end actuator 122.

[0074] In addition, Figure 7 In this embodiment, trigger 124 includes a locking lever 136. In one implementation, locking lever 136 can be biased (e.g., by a torsion spring) toward switching valve 134. In response to pressing switching valve 134 from its initial position toward handle 120, locking lever 136 can extend past and toward the distal side of switching valve 134, thereby preventing switching valve 134 from releasing back to its initial position. When locking lever 136 prevents switching valve 134 from moving, cryogenic fluid can continue to flow from cryogenic fluid source 126 to end actuator 122. To terminate refrigerant release, the user can move locking lever 136 against the bias force, allowing switching valve 134 to return to its initial position.

[0075] In some embodiments, the surgeon may apply a force of approximately 4 pounds to depress the switching valve 134 and cause cryogenic fluid to flow to the end effector 122. During some procedures, the surgeon may maintain this force on the switching valve 134 for approximately 30 seconds for each nostril of a given patient, and the procedure may be performed on multiple patients in a given day. Therefore, the locking lever 136 helps reduce finger fatigue for the surgeon operating the device 100 by allowing the cryogenic fluid to continue flowing without the surgeon maintaining a force on the switching valve 134 throughout the procedure. While the locking lever 136 provides this benefit, in some alternative embodiments, the locking lever 135 may be omitted from the device 100.

[0076] In the example, the switching valve 134 and the locking lever 136 are positioned near the handle 120, such that all adult operators are expected to be able to access the switching valve 134 with the fingers of the same hand holding the handle 120. As a result of these improvements over existing devices, the currently disclosed device 100 can now be properly operated with one hand. Thus, the device 100 can be configured to be held by the user like a pistol with a pistol grip, wherein the switching valve 134 is configured like a pistol trigger. Other exemplary arrangements are also possible.

[0077] Figure 8 A cross-sectional view of an example trigger 124 of the device 100 is shown, which uses positive pressure from the nitrous oxide tank to lift the diaphragm 146, thereby allowing flow between the proximal cryogenic line 148 and the distal cryogenic line 150. Figure 8As shown, trigger 124 includes a valve housing 152, a valve plug 154, a diaphragm 146, a locating screw 156, a valve stem 158, a switching valve 134, and a trigger spring 160. The locating screw 156 in the valve housing 152 forces the valve plug 154 and the diaphragm 146 into close contact with each other, thereby forming a seal around the perimeter of the valve housing 152. In its default state, trigger 124 is in the closed position, wherein the trigger spring 160 and the valve stem 158 provide sufficient force to press the diaphragm 146 against the surface of the valve plug 154, on which an opening leading to the proximal refrigeration line 148 is located. When the switching valve 134 is pressed, the valve housing 152, the valve plug 154, and the diaphragm 146 move away from the valve stem 158. Once the trigger 124 has moved a sufficient distance away from the valve stem 158, the force from the pressurized nitrous oxide becomes sufficient to break the seal between the diaphragm 146 and the orifice in the valve plug 154 leading to the proximal refrigeration line 148. This allows the diaphragm 146 to become dome-shaped, thereby creating a pressurized space connecting the proximal refrigeration line 148 and the distal refrigeration line 150. Releasing the switching valve 134 forces the valve housing 152, the valve plug 154, and the diaphragm 146 back to contact the valve stem 158 at a rate defined by the trigger spring 160, thereby closing the proximal refrigeration line 148 on the diaphragm 146 and the valve plug 154.

[0078] like Figure 8 As shown, the inner diameter of the distal refrigeration line 150 can be smaller than the inner diameter of the proximal refrigeration line 148. This arrangement ensures that when the diaphragm 146 is in the open position, the space below the diaphragm 146 experiences improved pressurization due to the additional resistance from the smaller-diameter distal refrigeration line 150. This improved pressurization of the distal refrigeration line 150 reduces the pressure drop near the distal refrigeration line 150 and allows for more efficient use of liquid refrigerant.

[0079] The pressurized cryogenic fluid source 126 may include a liquid cryoprotectant (e.g., nitrous oxide), but may also be another cryogenic liquid (e.g., liquid carbon dioxide or liquid chlorofluorocarbons, etc.). In use, the liquid cryoprotectant is introduced into the end effector 122 via a liquid cryoprotectant supply line connected to the cryogenic fluid source 126 in the handle 120 and travels coaxially through the probe shaft 102. The end effector 122 is configured as a liquid cryoprotectant evaporator and is configured to be pressed against the lateral nasal wall near the SPF as described above for cryoablation of at least one posterior nasal nerve. The structure and function of the end effector 122, as well as alternative examples, are described in detail below. The evaporated liquid cryoprotectant may be discharged into the room, for example, through the probe shaft 102 to one or more discharge ports 138 in the handle 120 (e.g., Figure 9 (As shown) or discharged near the proximal end 106 of the probe shaft 102. Therefore, no liquid or gaseous cryopropellant is introduced into the patient's nasal cavity.

[0080] In one example of this disclosure, such as Figures 10A-10B As shown, the end effector 122 of the device 100 includes: a planar member 142 defining a flat shape disposed at the distal end 104 of the probe shaft 102; and an expandable structure 144 surrounding the planar member 142 and coupled to the distal end 104 of the probe shaft 102. The planar member 142 includes an elongated structure with arcuate edges to define a wound-resistant surface. The expandable structure 144 can be accessed from (… Figure 10A The collapsed configuration shown expands to ( Figure 10B (As shown) Expandable configuration. The interior of the expandable structure 144 is in fluid communication with the cryogenic fluid source 126. The expandable structure 144 is configured to change from a collapsed configuration to an expanded configuration once the cryogenic fluid inside the expandable structure 144 evaporates. In use, the end effector 122 formed by the planar member 142 and the expandable structure 144 is configured as a cryogenic evaporation chamber, and the outer surface of the expandable structure 144 is configured as a cryogenic ablation surface. The expandable structure 144 is configured to apply a force of approximately, for example, 20 grams to 200 grams on the side nose wall.

[0081] The expandable structure 144 may be formed of an elastic material such as silicone rubber or polyurethane rubber. Alternatively, the expandable structure 144 may be formed of a substantially inelastic material (e.g., nylon or PET). In one example, the expandable structure 144 is configured to expand to a predetermined shape and size in an expansion configuration, and the predetermined shape and size correspond to the shape and size of the nasal tissue region to be treated by the needle. For example, the expandable structure 144 is configured such that the shape and size of the structure matches the shape and size of the dome of the middle nasal meatus defined by the tail of the middle turbinate, the middle turbinate, the lateral nasal walls, and the inferior turbinate, which is an example target location for ablation of the posterior nasal nerve for the treatment of rhinitis. Matching the size and shape of the expandable structure 144 to the size and shape of the target anatomy helps to improve tissue cryoablation and ablation of the posterior nasal nerve. The expandable structure 144 may have an expansion diameter between approximately 3 mm and 12 mm on one radial axis and may be configured such that the expansion diameter on one radial axis differs from that on another radial axis. The planar member 142 may include an elongated loop structure formed of rigid wire, configured to manipulate tissue within the nasal cavity. Furthermore, the planar member 142 may be coupled to the distal end 104 of an internal probe shaft 102, such that the planar member 142 is not attached to the interior of the expandable structure 144. In use, the device 100 is configured to cool the outer surface of the expandable structure 144 to -20°C to -90°C for less than 120 seconds to controllably freeze at a depth of less than 4 mm from the surface of the lateral nasal wall tissue region, thereby reducing at least one rhinitis symptom in the patient.

[0082] In some examples of this device 100, the planar member 142 may have a wide shape that tracks the perimeter of the expandable structure 144. Furthermore, in some examples, the planar member 142 may be coupled to the probe shaft 102 at a location approximately 15 mm from the expandable structure 144. For example... Figures 10A-10B As shown, with the aforementioned changes to the shape of the planar member 142 and the attachment configuration of the expandable structure 144, the expansion range of the expandable structure 144 can be improved, resulting in a greater degree of bilateral expansion (i.e., the expandable structure 144 expands away from the planar member 142 in both directions). Furthermore, the geometry of the planar member 142 and the expandable structure 144 enhances tissue contact, particularly in the treatment area (e.g., the middle nasal meatus), where simultaneous treatment of multiple portions of the lateral nasal wall and the middle turbinate itself may be necessary.

[0083] Figure 11 An improved insulation system for probe shaft 102 is shown according to an example. In particular, in addition to the polymer insulation layer covering the outside of the sleeve ( Figure 11 In addition to (not shown in the image), a dual-pipe system can also be used. For example... Figure 11 As shown, the proximal portion 118 of the probe shaft 102 includes a first tube 162 having a first diameter and a second tube 164 having a second diameter larger than the first diameter, such that an air gap separates the first tube 162 and the second tube 164. During cryotherapy, cryocooling flows through the smaller inner first tube 162. This smaller first tube 162 is covered by the larger second tube 164, such that an air gap separates the two tubes. As described above, a polymer insulating layer covers the entire composite. As a result, the insulation between the outer surface of the probe shaft 102 and the inner exhaust tube (e.g., the first tube 162) is increased, and therefore, during use, the exterior of the probe shaft 102 experiences little or no temperature change.

[0084] A preferred embodiment of this insulation system may utilize a hypotube made of stainless steel or other similar materials. Stainless steel provides sufficient mechanical strength while allowing for a minimum wall thickness. Limiting the wall thickness maximizes the air gap size between adjacent tubes, thereby maximizing insulation. In one example, the inner first tube 162 may have an inner diameter of approximately 0.046 inches and an outer diameter of approximately 0.056 inches. This inner diameter ensures that the refrigerant vent has sufficient area to flow through the inner lumen to achieve the required pressure within the end effector 122. The outer diameter also helps prevent kinking of the first tube 162 during use. In one example, the outer second tube 164 has an inner diameter of approximately 0.085 inches and an outer diameter of approximately 0.095 inches. The outer second tube 164 with the stated outer diameter minimizes the profile of the probe shaft 102 navigating within the nasal cavity, wherein the inner diameter of the outer second tube 164 is again chosen to prevent kinking. In the example described, the resulting cavitation for insulation is approximately 0.014-0.015 inches. In a preferred embodiment, the first tube 162 and the second tube 164 are located at the center of the distal and proximal edges. Materials such as stainless steel provide the additional benefit of ensuring that the first tube 162 and the second tube 164 maintain their relative spacing, thereby maximizing insulation and preventing cold spots.

[0085] The probe shaft 102 can be made of a variety of biocompatible materials. In one example, the distal portion 112 of the probe shaft 102 includes a first material, and the proximal portion 118 of the probe shaft 102 includes a second material different from the first material. In one example, the first material includes a polymer, and the second material includes stainless steel. This difference in materials can provide a difference in flexibility between the proximal portion 118 and the distal portion 112 of the probe shaft 102, as described in more detail below. Figure 11 The distal end 104 of the probe shaft 102 in this example is shown.

[0086] In particular, Figure 11The distal end 104 of the probe shaft 102 is shown as a multi-lumen polymer tube 166 located between the proximal portion 118 of the probe shaft 102 (shown as an inner first tube 162) and the planar member 142. As discussed above, the inner first tube 162 extends further from the distal end 104 of the probe shaft 102 into a larger outer second tube 164 surrounding the inner first tube 162. As a non-limiting example, the first tube 162 and the second tube 164 may comprise stainless steel. The paddle legs of the planar member 142 can be laser-welded into place after passing through the flexible polymer tube 166. This configuration maintains the required stiffness in the plane of the planar member 142 and continues to provide a sealed internal lumen for venting, but due to the inherent flexibility of the polymer tube 166, it results in increased flexibility in the plane of intended tissue contact. In other words, bending of the end effector 122 can begin along the probe shaft 102 from a more proximal location, thereby allowing a similar degree of bending to be achieved with a smaller total force applied.

[0087] In the currently disclosed example of device 100, the planar member 142 may be constructed of stainless steel wire with a diameter ranging from about 0.010 inches to about 0.020 inches (preferably 0.015 inches). In the example, the wire is shaped to ensure that it does not obstruct the flow of refrigerant spray from probe shaft 102, and the wire narrows near the proximal side of planar member 142 to minimize the profile of the structure. Figure 2 The shape of the planar member 142 shown is an example of a suitable shape, but it will be apparent to those skilled in the art that alternative shapes are possible without loss of novelty. In some examples, the length of the legs of the planar member 142 may be from about 5 mm to about 50 mm, with a preferred length of about 30 mm.

[0088] In the currently disclosed example of device 100, the wire legs of the planar member 142 can be inserted into a tube (e.g., a three-lumen polymer tube 166). Each leg can be inserted into an independent lumen, the dimensions of which are suitably designed to provide a tight fit around the wire. In the example, the central lumen may remain open for use for other device purposes, such as an exhaust lumen for evaporating refrigerant material. In variant examples, the polymer tube 166 may include fewer or more than three lumens. In some examples, the polymer tube 166 is positioned such that its distal end contacts the proximal end of the planar member 142. The polymer tube 166 is preferably made of a thermoplastic elastomer with a hardness in the range of 40-80 Shore D or another suitable polymer material that maintains suitable flexibility while retaining the ability to be heat-treated and attached to similar materials. In a preferred example, the polymer tube 166 has a length of about 20 mm. In one example, during device construction, the proximal end of the central lumen of the polymer tube 166 is pressed against the bent, rigid proximal portion 118 of the probe shaft 102, such that the polymer tube 166 overlaps the proximal portion 118 of the probe shaft 102 by approximately 2 mm to approximately 7 mm. The wire legs of the planar member 142 can then be secured to the probe shaft 102 via laser welding or a similar technique. In this example, the inner first tube 162 extends the entire length of the probe shaft 102 and is secured to a larger outer second tube 164 within the handle 120. As described above, this configuration allows for a flexible and incompressible device neck of 10-15 mm, which retains a sealed internal lumen for refrigerant venting.

[0089] The presence of a polymer tube 166 at the distal end 104 of the probe shaft 102 results in an unexpectedly significant reduction in the force required to place the planar member 142 flush with a flat surface. Specifically, currently disclosed devices may require less than 4 ounces of force to place the planar member 142 flush with a surface, and preferably less than about 2 ounces. By incorporating the novel design aspects disclosed herein, the flexural position of the probe shaft 102 is shifted to a more lateral position on the device 100, thereby allowing the entire planar member 142 to rest against a flat surface such as the lateral nasal wall. This enables the device 100 to accommodate a wider range of anatomical structures without requiring the operator to apply undue large tissue forces to establish proper tissue contact.

[0090] Additional examples of exemplary devices are described below. Features of any device or device component described in any example herein may be used in any other applicable examples of a device or device component. In one example, this disclosure provides a surgical probe configured for ablation, wherein the surgical probe includes a surgical probe shaft comprising: an elongated structure having a distal end and a proximal end; an expandable structure attached to the distal end of the probe shaft, the expandable structure having a collapsed configuration and an expanded configuration; a member attached to the distal end and extending within the expandable structure such that the member is not attached to the interior of the expandable structure, wherein the member defines a flattened shape sized to rest against a lateral nasal wall near a posterior nasal nerve; and a lumen in fluid communication with the interior of the expandable structure.

[0091] Device 100 can be configured as a simple mechanical device without electronic components, as shown. Alternatively, device 100 can be configured with at least one electronic function. In one example, a temperature sensor can be arranged near the end effector 122. As an example, Figure 12A-12D Depicting Figure 2-11 The illustrated device 100 includes temperature sensors 1268 located at multiple locations. Typically, the temperature sensors 1268 measure temperature and generate a signal indicating that temperature. In this example, the device 100 may be configured to take one or more actions based on the temperature sensed by the temperature sensors 1268.

[0092] exist Figure 12A In this embodiment, temperature sensor 1268 is positioned on the outside of probe shaft 102, near end effector 112. In one example, temperature sensor 1268, located on the outside of probe shaft 102 and near end effector 112, can help determine whether cryotherapy has extended beyond the desired target area. For example, if temperature sensor 1268 senses a temperature below a threshold temperature, it can instruct device 100 to stop supplying cryotherapy to end effector 122. In some embodiments, temperature sensor 1268 and / or controller may be configured to automatically stop supplying cryotherapy to end effector 122 in response to temperature sensor 1268 sensing a temperature below a threshold temperature.

[0093] exist Figure 12BIn this configuration, temperature sensor 1268 is positioned within probe shaft 102, near end effector 112. In one example, temperature sensor 1268, located within probe shaft 102 and near end effector 112, senses a temperature indicating whether refrigerant is being adequately converted from liquid to gas. For example, temperature sensor 1268 and / or a controller may determine that refrigerant is not being adequately converted from liquid to gas, and the refrigerant flows as liquid from end effector 122 to handle 120 in response to temperature sensor 1268 determining that the temperature sensed by temperature sensor 1268 is below a threshold temperature. As an example, the threshold temperature may be approximately -88 degrees Celsius.

[0094] exist Figure 12C In this configuration, the temperature sensor 1268 is positioned within the internal space of the expandable structure 144 of the end effector 122. More specifically, in Figure 12C In this configuration, planar member 142 is a thermocouple providing both the aforementioned structural and temperature sensing functions. Similar to temperature sensor 1268 located within probe shaft 102, temperature sensor 1268, located within the expandable structure 144 of end effector 122, can help determine whether the refrigerant is being adequately converted from liquid to gas. For example, temperature sensor 1268 and / or the controller can determine that the refrigerant has not been adequately converted from liquid to gas, and that the refrigerant, in response to temperature sensor 1268 determining that the temperature sensed by temperature sensor 1268 is below a threshold temperature, flows as liquid from end effector 122 to handle 120. As an example, the threshold temperature could be approximately -88 degrees Celsius.

[0095] exist Figure 12D In this embodiment, a temperature sensor 1268 is positioned on the outer surface of the expandable structure 144 of the end effector 122 (e.g., on the treatment side of the end effector 122 positioned to contact the target tissue during the treatment process). In one example, the temperature sensor 1268 located on the outer surface of the expandable structure 144 can measure a temperature that can indicate the effectiveness of the treatment process. For example, the temperature sensed by the temperature sensor 1268 can indicate when the target tissue has reached the desired temperature. In some embodiments, the device 100 may include one or more components configured to provide a feedback loop based on the temperature sensed by the temperature sensor 1268 for controlling the supply of cryoprotectant to the end effector 122. Although Figure 12A-12D Individual temperature sensors 1268 at different locations on device 100 are shown, but device 100 can be... Figure 12A-12D One or more temperature sensors 1268 are included at the locations shown. Therefore, the device 100 may have multiple temperature sensors 1268 at multiple locations, including those referenced above. Figure 12A-12D The locations shown and described.

[0096] As mentioned above, in Figure 12A-12D In some examples of the illustrated device 100, the temperature sensor 1268 may be used to measure, display, and / or control the temperature of the surgical object of interest. For example, in one embodiment, the temperature sensor 1268 may be configured to sense the temperature at which cryoprotectant evaporates within the end effector 122. The temperature sensor 1268 may additionally or optionally be configured to sense the temperature of the tissue of the surgical object of interest.

[0097] Trigger 124 may also optionally include a servo mechanism configured to adjust the flow rate of cryoprotectant in response to sensed temperature in order to control desired surgical parameters. Specifically, device 100 may be configured to automatically adjust the flow rate of liquid cryoprotectant in response to one or more of the following parameters: evaporator temperature, evaporator pressure, tissue temperature, evaporator exhaust temperature, or the time elapsed for cryoprotectant flow. The flow rate may be adjusted in a continuous simulation manner and / or by alternating on / off flow regulation.

[0098] In addition to temperature sensing capabilities, the device 100 may also be configured with a camera and / or a light source disposed near the distal end 104 of the probe axis 102. The camera and / or light source may be used, for example, to identify nasal anatomical landmarks and to guide the placement of the end effector 122 against the nasal lateral wall to ablate the target posterior nasal nerve. Figure 13 An apparatus 100, including a camera 1370 and a light source 1372, is depicted according to one example.

[0099] An ultrasonic or optical Doppler flow sensor may also be positioned near the distal end 104 of the probe axis 102 and may be used, for example, to locate arteries associated with a target posterior nasal nerve, serving as a device for locating the target posterior nasal nerve. In one such example, the Doppler flow sensor includes an ultrasonic detector. In another such example, the Doppler flow sensor includes an optical detector. In one example, the artery associated with at least one nasal nerve includes an artery originating from the sphenopalatine branch. Figure 14 An apparatus 100 comprising one or more Doppler flow sensors 1474A-1474D is described according to one example. Specifically, Doppler flow sensors 1474A and 1474B are positioned on the distal portion 112 of the probe shaft 102, Doppler flow sensor 1474C is positioned on the proximal portion 118 of the probe shaft 102, and Doppler flow sensor 1474D is positioned on the end effector 122.

[0100] although Figure 14A device 100 with four Doppler flow sensors 1474A-1474D is shown, but in other examples, the device 100 may have fewer or more Doppler flow sensors 1474A-1474D. Furthermore, although... Figure 14 Doppler flow sensors 1474A-1474D are shown in specific locations on device 100, but according to other examples, device 100 may include one or more Doppler flow sensors 1474A-1474D in one or more alternative locations.

[0101] In addition, one or more electrodes may be disposed near the distal end 104 of the probe shaft 102, which can be used to electrically stimulate or electrically interrupt the function of the target posterior nasal nerve, thereby using the observed physiological response to the stimulation or block to confirm the correct surgical positioning of the end effector 122 before ablation and / or to confirm the effectiveness of ablation by determining the changes in physiological response before and after ablation. Figure 15 An apparatus 100 comprising one or more electrodes 1576A-1576D is depicted according to one example. Specifically, electrodes 1576A and 1576B are positioned on the distal portion 112 of the probe shaft 102, electrode 1576C is positioned on the proximal portion 118 of the probe shaft 102, and electrode 1576D is positioned on the end effector 122.

[0102] although Figure 15 A device 100 with four electrodes 1576A-1576D is shown, but in other examples, the device 100 may have fewer or more electrodes 1576A-1576D. Furthermore, although... Figure 15 Electrodes 1576A-1576D at specific locations on device 100 are shown, but according to other examples, device 100 may include one or more electrodes 1576A-1576D at one or more alternative locations.

[0103] Any number of temperature-sensing endoscopic instruments, servo-controlled refrigerant control valves, ultrasonic or optical Doppler flow detection and / or electroneural stimulation and blocking mechanisms can be optionally incorporated into the device described herein.

[0104] In use, this surgical probe can be used to treat tissue areas within the nasal cavity, typically involving: advancing the distal end of the surgical probe shaft through the nasal cavity to the vicinity of a tissue area containing nasal nerves; introducing cryogenic fluid into an expandable structure attached to the distal end of the probe shaft, causing the expandable structure to expand from a collapsed configuration to an expanded configuration resting against the tissue area; positioning a member relative to the tissue area, wherein the member is attached to the distal end of the probe shaft and extends within the expandable structure such that the member is not attached to the interior of the expandable structure, and wherein the member defines a flattened shape sized to rest against the tissue area near the nasal nerves; and maintaining the member against the tissue area until the nasal nerves are ablated by cryogenic fluid.

[0105] Another example of this disclosure is a cryosurgical probe device for ablation of nasal nerves, the device comprising: a handle at the proximal end; a probe shaft, wherein a shovel-shaped cryoablation element is mounted near the distal end of the shaft, wherein the handle is configured to contain a cryotherapy source and control the flow of cryotherapy to the cryoablation element, and the geometry of the probe shaft and the cryoablation element is configured for cryoablation of the nasal mucosa, including nasal nerves, according to the method disclosed herein.

[0106] Another example of this disclosure is a cryosurgical probe device for ablation of nasal mucosa, the device comprising: a handle at a proximal end; a probe shaft, wherein a bullet-shaped cryoablation element is mounted near the distal end of the shaft, wherein the handle is configured to contain a cryogen source and control the flow of cryogen to the cryoablation element, and the geometry of the probe shaft and the cryoablation element is configured to cryoablate the nasal mucosa according to the method disclosed herein.

[0107] Another example of this disclosure is a cryosurgical probe device for ablation of a nasal nerve, the device comprising: a handle at a proximal end; a probe shaft, wherein a bullet-shaped cryoablation element is mounted near the distal end of the shaft, wherein the handle is configured to contain a cryotherapy source and control cryotherapy flow to the cryoablation element, the probe shaft is configured with a user-operable deflectable distal segment, and the geometry of the probe shaft and the cryoablation element is configured to cryoablate the nasal nerve according to the method disclosed herein.

[0108] Another example of this disclosure is a cryosurgical probe device for ablation of a nasal nerve, the device comprising: a handle at a proximal end; a probe shaft, wherein a cylindrical cryoablation element is mounted near the distal end of the shaft, wherein the handle is configured to contain a cryotherapy source and control cryotherapy flow to the cryoablation element, wherein the cryoablation element comprises a linear segmented cryoablation element, and the geometric parameters of the probe shaft and the cryoablation element are configured for cryoablation of the nasal nerve according to the method disclosed herein.

[0109] Another example of this disclosure is a cryosurgical probe device for ablation of nasal nerves, the device comprising: a handle at a proximal end; a probe shaft, wherein a cylindrical cryoablation element is mounted near the distal end of the shaft, wherein the handle is configured to contain a cryotherapy source and control cryotherapy flow to the cryoablation element, wherein the cryoablation element comprises a semi-circular cryoablation element, and the geometry of the probe shaft and the cryoablation element is configured to perform cryoablation of target tissue, including nasal nerves, according to the method disclosed herein.

[0110] Another example of this disclosure is a cryosurgical probe device for ablation of nasal nerves, the device including a handle at the proximal end; a probe shaft, wherein a cylindrical cryoablation element is mounted near the distal end of the shaft, wherein the handle is configured to contain a cryotherapy source and control the flow of cryotherapy to the cryoablation element, wherein the cryoablation element includes a helical cryoablation element, and the geometry of the probe shaft and the cryoablation element is configured to perform cryoablation of target nasal tissue, including nasal nerves, according to the method disclosed herein.

[0111] Another example of this disclosure is a cryosurgical probe device for ablation of a nasal nerve, the device comprising: a proximal end; a probe shaft having a cryoablation element including a balloon mounted near the distal end of the shaft, wherein the proximal end is configured to receive cryotherapy from a cryotherapy source, wherein the cryotherapy source includes means for controlling the flow of cryotherapy to the cryoablation element, and the geometric parameters of the probe shaft and the cryoablation element are configured for cryoablation of the nasal nerve according to the method disclosed herein.

[0112] Another example of this disclosure is a cryosurgical probe device for ablation of nasal nerves, the device comprising: a handle at a proximal end; a probe shaft having a cylindrical cryoablation element including a balloon mounted near the distal end of the shaft, wherein the handle is configured to contain a cryotherapy source and control cryotherapy flow to the cryoablation element, and the geometry of the probe shaft and the cryoablation element is configured for cryoablation of target nasal tissue, including nasal nerves, according to the method disclosed herein.

[0113] Another example of this disclosure is a cryosurgical probe device for ablation of a nasal nerve, the device comprising: a handle at a proximal end; a probe shaft having a cylindrical cryoablation element including a balloon, wherein two side chambers are arranged near the distal end of the shaft, wherein the handle is configured to contain a cryogen source and control cryogen flow to the cryoablation element, wherein one chamber of the balloon is configured as a cryogen expansion chamber and the second chamber is configured as a thermal insulation chamber, and the geometry of the probe shaft and the cryoablation element is configured for cryoablation of the nasal nerve according to the method disclosed herein.

[0114] Another example of this disclosure is a cryosurgical probe device for ablation of a nasal nerve, the device comprising: a handpiece at the proximal end; a probe shaft having an "I"-shaped cryoablation element including a balloon mounted near the distal end of the shaft, wherein the handpiece is configured to contain a cryotherapy source and control cryotherapy flow to the cryoablation element, and the geometry of the probe shaft and the cryoablation element is configured for cryoablation of the nasal nerve according to the method disclosed herein.

[0115] Another example of this disclosure is a cryosurgical probe device for ablation of nasal nerve function, the device comprising: a handpiece at the proximal end; a probe shaft having a "J"-shaped cryoablation element including a balloon mounted near the distal end of the shaft, wherein the handpiece is configured to contain a cryotherapy source and control cryotherapy flow to the cryoablation element, and the geometry of the probe shaft and the cryoablation element is configured for cryoablation of the nasal nerve according to the method disclosed herein.

[0116] Another example of this disclosure is a cryosurgical probe device for ablation of a nasal nerve, the device comprising: a handle at a proximal end; a probe shaft, wherein a cryoablation element is mounted near the distal end of the shaft, wherein the handle is configured to contain a cryotherapy source and control cryotherapy flow to the cryoablation element, wherein an aspiration device associated with the cryoablation element is configured to stabilize the position of the cryoablation element on target tissue, and the geometry of the probe shaft and the cryoablation element is configured to cryoablate the nasal nerve according to the method disclosed herein.

[0117] One aspect of this disclosure is a method for cryoablation of a nasal nerve, the method comprising placing a layer of oil or gel on the surface of a cryoablation element, then pressing the cryoablation element against the lateral wall of the nasal cavity near the nasal nerve, and then ablating the nasal nerve using the cryoablation element, wherein the oil or gel prevents frozen nasal tissue from adhering to the cryoablation element.

[0118] Another aspect of this disclosure is an electrosurgical probe device for ablation of nasal nerves, the device comprising: a handpiece at a proximal end; a probe shaft having a radiofrequency (RF) ablation element including at least one RF electrode mounted near the distal end of the shaft; and an electrical connector located near the handpiece, configured to connect the RF ablation element to a radiofrequency energy source, wherein the geometry of the probe shaft and the RF ablation element is configured for radiofrequency ablation of the nasal nerves according to the method disclosed herein.

[0119] Another example of this disclosure is an electrosurgical probe device for ablation of nasal nerves, the device comprising: a handpiece at a proximal end; a probe shaft having a radiofrequency ablation element including at least one radiofrequency electrode mounted near the distal end of the shaft; an electrical connector disposed near the handpiece and configured to connect the radiofrequency ablation element to a radiofrequency energy source; and a fluid connector disposed near the handpiece for connecting at least one fluid port associated with the radiofrequency ablation element to a pressurized liquid source, wherein the geometric parameters of the probe shaft and the radiofrequency ablation element are configured for radiofrequency ablation of the nasal nerves according to the method disclosed herein.

[0120] Another example of this disclosure is an electrosurgical probe device for ablation of nasal nerves, the device comprising: a handpiece at a proximal end; a probe shaft having a radiofrequency ablation element including at least one radiofrequency electrode mounted near the distal end of the shaft; and an electrical connector disposed near the handpiece, configured to connect the radiofrequency ablation element to a radiofrequency energy source, wherein the geometry of the probe shaft and the radiofrequency ablation element is configured for radiofrequency ablation of the nasal nerve according to the method disclosed herein, wherein the radiofrequency ablation element includes a monopolar electrosurgical configuration comprising one or more electrodes.

[0121] Another example of this disclosure is an electrosurgical probe device for ablation of nasal nerves, the device comprising: a handpiece at a proximal end; a probe shaft having a radiofrequency ablation element including at least one radiofrequency electrode mounted near the distal end of the shaft; and an electrical connector disposed near the handpiece, configured to connect the radiofrequency ablation element to a radiofrequency energy source, wherein the geometry of the probe shaft and the radiofrequency ablation element is configured for radiofrequency ablation of the nasal nerve according to the method disclosed herein, wherein the radiofrequency ablation element includes a bipolar electrosurgical configuration comprising two or more electrodes.

[0122] Another example of this disclosure is an electrosurgical probe device for ablation of nasal nerves, the device comprising: a handpiece at a proximal end; a probe shaft having a radiofrequency ablation element including at least one radiofrequency electrode mounted near the distal end of the shaft; and an electrical connector disposed near the handpiece, configured to connect the radiofrequency ablation element to a radiofrequency energy source, wherein the geometry of the probe shaft and the radiofrequency ablation element is configured for radiofrequency ablation of the nasal nerve according to the method disclosed herein, wherein the radiofrequency ablation element is arranged on a cylindrical, "J", "U", or "T" shaped structure near the distal end of the shaft.

[0123] Another example of this disclosure is an electrosurgical probe device for ablation of nasal nerves, the device comprising: a handpiece at a proximal end; a probe shaft having a radiofrequency ablation element including at least one radiofrequency electrode mounted near the distal end of the shaft; and an electrical connector disposed near the handpiece, configured to connect the radiofrequency ablation element to a radiofrequency energy source, wherein the geometry of the probe shaft and the radiofrequency ablation element is configured for radiofrequency ablation of the nasal nerve according to the method disclosed herein, wherein the radiofrequency ablation element is configured in a transverse or radial arrangement.

[0124] Another example of this disclosure is an electrosurgical probe device for ablation of nasal nerves, the device comprising: a handpiece at a proximal end; a probe shaft having a radiofrequency ablation element including at least one radiofrequency electrode mounted near the distal end of the shaft; and an electrical connector disposed near the handpiece, configured to connect the radiofrequency ablation element to a radiofrequency energy source, wherein the geometry of the probe shaft and the radiofrequency ablation element is configured for radiofrequency ablation of the nasal nerve according to the method disclosed herein, wherein the radiofrequency ablation element comprises a circular array of dome electrodes arranged on a flat, electrically insulating surface, wherein the dome electrodes are optionally associated with a fluid flushing port.

[0125] Another example of this disclosure is an electrosurgical probe for ablation of a nasal nerve, the probe comprising: a handle at a proximal end; a probe shaft having a radiofrequency ablation element including at least one radiofrequency electrode mounted near the distal end of the shaft; an electrical connector disposed near the handle, configured to connect the radiofrequency ablation element to a radiofrequency energy source, whereby the geometry of the probe shaft and the radiofrequency ablation element is configured for radiofrequency ablation of the nasal nerve according to the method disclosed herein, wherein the radiofrequency ablation element comprises: a linear array of dome electrodes arranged on a flat, electrically insulating surface, wherein the dome electrodes are optionally associated with a fluid flushing port; and a needle configured to inject fluid into a submucosal space.

[0126] Another example of this disclosure is an electrosurgical probe device for ablation of nasal nerves, the device comprising: a handpiece at a proximal end; a probe shaft having a radiofrequency ablation element including at least one radiofrequency electrode mounted near the distal end of the shaft; and an electrical connector disposed near the handpiece, configured to connect the radiofrequency ablation element to a radiofrequency energy source, whereby the geometry of the probe shaft and the radiofrequency ablation element is configured for radiofrequency ablation of the nasal nerves according to the method disclosed herein, wherein the radiofrequency ablation element includes at least one needle configured for interstitial radiofrequency ablation.

[0127] Another example of this disclosure is an electrosurgical probe device for ablation of a nasal nerve, the device comprising: a handpiece at a proximal end; a probe shaft including a distal end and a proximal end; and an integrated circuit including a radiofrequency generator disposed near the handpiece and a radiofrequency ablation element disposed near the distal end of the shaft, wherein the geometric parameters of the probe shaft and the radiofrequency ablation element are configured for radiofrequency ablation of the nasal nerve according to the method disclosed herein.

[0128] Another example of this disclosure is an ultrasonic energy emission probe device for ablation of nasal nerves, the device comprising: a handle at a proximal end; a probe shaft having an ultrasonic energy ablation element including at least one ultrasonic energy emitter mounted near the distal end of the shaft; and an electrical connector near the handle configured to connect the ultrasonic energy emitter to an ultrasonic energy generator, wherein the geometry of the probe shaft and the ultrasonic energy emitter is configured for ultrasonic energy ablation of the nasal nerves according to the method disclosed herein.

[0129] Another example of this disclosure is an ultrasonic energy emission probe device for ablation of nasal nerves, the device comprising: a handle at a proximal end; a probe shaft having an ultrasonic energy ablation element including at least one ultrasonic energy emitter mounted near the distal end of the shaft; an electrical connector near the handle configured to connect the ultrasonic energy emitter to an ultrasonic energy generator; and at least one fluid path communicating at least one fluid connector near the handle to an ultrasonic energy emitter configured to cool the ultrasonic energy emitter during ultrasonic energy emission, wherein the geometry of the probe shaft and the ultrasonic energy emitter is configured for ultrasonic energy ablation of the nasal nerves according to the method disclosed herein.

[0130] Methods of using any of the above-described devices are now provided. The posterior nasal nerves (PNNs) comprise nerves originating from the spiculated prostate (SPG) and innervating the nasal mucosa on the posterior side of the nasal cavity. Ablation of these nerves, along with other nerves in the nasal cavity, results in a reduction or interruption of parasympathetic nerve signals, which cause nasal congestion and runny nose in patients with chronic rhinitis (allergic or non-allergic). The devices and methods described herein are configured to ablate one or more of these nasal nerves to reduce or eliminate rhinitis.

[0131] Typically, the aforementioned devices can be used to ablate nasal nerves in nasal tissue regions of a patient's nasal cavity. A method for treating a nasal tissue region adjacent to the at least one nerve within the nasal cavity may include introducing a distal end of a probe shaft into the nasal cavity, wherein the distal end has an end effector having a first configuration with a low profile shaped for manipulating tissue within the nasal cavity. The distal end may be positioned near the tissue region containing the nasal nerve. Once properly positioned, the distal end may be reconfigured from the first configuration to a second configuration shaped to contact and follow the tissue region. As described herein, the distal end may subsequently be used to ablate nasal nerves within the tissue region using a number of different tissue treatment mechanisms, such as cryotherapy.

[0132] In one particular variant, when treating a tissue region, the distal end can be specifically positioned near the tissue region surrounded by the middle turbinate, inferior turbinate, and lateral walls of the nasal cavity, thus forming a fornix and containing the posterior nasal nerve (PNN). The distal end can be reconfigured to treat that tissue region accordingly.

[0133] Various distal configurations can be used to treat tissue areas, provided that the distal end is configured for placement within the narrow confines of the nasal cavity, and more specifically, within the tissue area surrounding the middle turbinate, inferior turbinate, lateral nasal walls, and inferior meatus. Other anatomical locations within the nasal cavity can be used as alternatives or additionally with the configurations described herein for treatment.

[0134] As described above, one example of a surgical probe configured for ablation of a tissue region (e.g., the nasal cavity) includes a surgical probe device having: a surgical probe shaft including an elongated structure having a distal end and a proximal end; and an expandable structure attached to the distal end of the probe shaft, the expandable structure having a collapsed configuration and an expanded configuration. A lumen is defined through the shaft, the lumen being in fluid communication with the interior of the expandable structure. A member can be attached to the distal end and extend within the expandable structure surrounding the member, such that the member is not attached to the interior of the expandable structure. Furthermore, the member can define a trauma-resistant shape, its dimensions designed for pressing against a nasal tissue region and manipulating the nasal tissue region through the expandable structure.

[0135] Examples of using this structure to treat the tissue region may typically include advancing the distal end of a surgical probe shaft through the nasal cavity to the vicinity of the target nasal tissue region, introducing cryogenic fluid into an expandable structure attached to the distal end of the probe shaft, such that the expandable structure expands from a collapsed configuration to an expanded configuration against the target nasal tissue region.

[0136] The position of the component relative to the target nasal tissue region can be adjusted. The component is attached to the distal end of the probe shaft and extends within an expandable structure that surrounds the component, ensuring that the component is not attached to the interior of the expandable structure. The surgeon can apply pressure distally, pressing the component against the interior of the expandable structure, which in turn presses against the target nasal tissue region. The component defines a trauma-resistant shape, sized to press against and manipulate the target nasal tissue region. The component can be maintained against the interior of the expandable structure and the target nasal tissue region until the target nasal tissue region is cryoablated.

[0137] Any ablation device described herein can be used to ablate a single nerve branch or multiple nerve branches.

[0138] Another aspect of this disclosure is a method for treating rhinitis by ablation of nasal nerves. The method may include inserting a distal end of a surgical probe configured for cryo-neurolysis into a patient's nostril. As described above, a surgical head disposed on the proximal end of the probe shaft may include a liquid cryoprotectant reservoir. A distal expandable structure may be positioned against the lateral nasal wall near the target nasal nerve, and then flow of liquid cryoprotectant to the expandable structure may be actuated for a period sufficient to cryo-ablate a target region in the nose including the target nasal nerve.

[0139] The method may also involve targeting at least one additional posterior nasal nerve in the ipsilateral nasal cavity or the posterior nasal nerve in the contralateral nasal cavity.

[0140] The method may include controlling the flow of liquid refrigerant into an evaporation chamber based on at least one predetermined parameter, which may include one or more of the following parameters: cryogenic liquid flow rate, cryogenic liquid flow time, cryogenic liquid evaporation pressure, cryogenic liquid evaporation temperature, cryogenic gas emission temperature, visual measurement of tissue freezing, ultrasonic measurement of tissue freezing, or volume of cryogenic liquid supplied by a cryogenic liquid reservoir.

[0141] The method may include determining the location of a target nasal nerve, which may involve one or more of the following targeting techniques: endoscopic determination based on nasal anatomical landmarks, electrostimulation of the target nasal nerve while observing a physiological response to stimulation, electrostimulation of the target nasal nerve while observing a physiological response to electrostimulation, or identification of arteries associated with the target nasal nerve using techniques such as ultrasound or optical Doppler flow.

[0142] Although the currently disclosed devices and methods have been discussed primarily in the context of cryotherapy, the devices, systems, and methods described herein can be implemented using other ablation and non-ablation surgical techniques. Examples, for instance, may include devices, systems, and methods utilizing heating / high-temperature therapy. Examples utilizing heating / high-temperature therapy may be structurally and procedurally similar to examples utilizing cryotherapy. Heat sources used in conjunction with thermotherapy-based therapies may include radiofrequency energy, microwave energy, ultrasonic energy, resistance heating, exothermic chemical reactions, combinations thereof, and other heat sources known to those skilled in the art. Furthermore, this disclosure may be applied as a standalone system or method, or as part of an integrated medical system. It should be understood that the different aspects of this disclosure may be understood individually, jointly, or in combination with each other.

[0143] Furthermore, although the currently disclosed devices and methods are primarily discussed in the context of ablation of at least one nasal nerve associated with the lateral nasal wall of the patient's nasal cavity, the treatment can also be applied, either additionally or as an option, to the septum, the roof of the nasal cavity, or other areas of the nasal cavity.

[0144] The methods described herein can be effectively used with any examples or variations of the above-described apparatus and systems, as well as other examples and variations not explicitly described in this document. Features of any apparatus or apparatus component described in any example herein can be used in any other applicable example of an apparatus or apparatus component.

[0145] It should be understood that the arrangement structures described herein are for illustrative purposes only. Therefore, those skilled in the art will understand that other arrangement structures and other elements (e.g., machines, interfaces, functions, sequences, and functional groupings) can be used instead, and some elements can be omitted entirely depending on the desired outcome. Furthermore, many of the elements described are functional entities that can be implemented as discrete or distributed components or combined with other components, implemented in any applicable combination and location, or combined with other structural elements described as independent structures.

[0146] While several aspects and examples have been disclosed herein, others will be apparent to those skilled in the art. The various aspects and examples disclosed herein are for illustrative purposes and are not intended to be limiting; the true scope is indicated by the appended claims and the full scope of their equivalents. It should also be understood that the terminology used herein is for the purpose of describing particular examples only and is not intended to be limiting.

Claims

1. A device for ablating at least one nasal nerve in a region of nasal tissue, comprising: A probe shaft having a distal end and a proximal end, wherein the probe shaft has a curved portion such that the longitudinal axis of the distal portion of the probe shaft has a non-zero angle relative to the longitudinal axis of the proximal portion of the probe shaft, wherein the distal portion extends from the distal end of the probe shaft to the curved portion, and the proximal portion extends from the proximal end of the probe shaft to the curved portion, the flexibility of the distal portion of the probe shaft is greater than the flexibility of the proximal portion of the probe shaft, the flexibility of the distal portion of the probe shaft being approximately two to approximately four times the flexibility of the proximal portion of the probe shaft, and the flexibility difference between the proximal and distal portions provides a flexural position at the curved portion; The housing is attached to the proximal end of the probe shaft; A handle that is attached to the housing; An end effector coupled to the distal end of the probe shaft, wherein, when the distal end of the probe shaft is advanced through the patient's nasal cavity and positioned near a nasal tissue region having at least one nasal nerve, the end effector defines a trauma-resistant surface, and the end effector is configured to transmit lateral pressure onto the nasal tissue region; and A trigger positioned in the handle, wherein actuation of the trigger causes the end effector to ablate at least one nasal nerve when the end effector contacts the nasal tissue region.

2. The apparatus of claim 1, wherein, The non-zero angle between the longitudinal axis of the distal portion of the probe shaft and the longitudinal axis of the proximal portion of the probe shaft is approximately 15 degrees to approximately 25 degrees.

3. The apparatus according to any one of claims 1-2, wherein, The bent portion of the probe shaft is positioned approximately 4 cm from the distal end of the end effector, and the bent portion of the probe shaft causes the distal end of the end effector to be laterally offset by approximately 1 cm relative to the longitudinal axis of the proximal portion of the probe shaft.

4. The apparatus according to any one of claims 1-2, wherein, The proximal end of the probe shaft extends into the housing, and the proximal portion of the probe shaft extends from the proximal end of the probe shaft to the curved portion.

5. The apparatus according to any one of claims 1-2, wherein, The probe shaft can rotate 180 degrees relative to the housing.

6. The apparatus according to any one of claims 1-2, wherein, The distal portion of the probe shaft comprises a first material, and the proximal portion of the probe shaft comprises a second material different from the first material.

7. The apparatus of claim 6, wherein, The first material includes a polymer, and the second material includes stainless steel.

8. The apparatus according to any one of claims 1-2, wherein, The proximal portion of the probe shaft includes a first tube having a first diameter and a second tube having a second diameter greater than the first diameter, such that an air gap separates the first tube and the second tube.

9. The apparatus according to any one of claims 1-2, wherein, The at least one nasal nerve includes the posterior nasal nerve of the nasal branch of the pterygopalatine canal nerve.

10. The apparatus according to any one of claims 1-2, wherein, The at least one nasal nerve includes a parasympathetic nerve.

11. The apparatus according to any one of claims 1-2, wherein, The end effector is configured to ablate the at least one nasal nerve using cryogenic fluid, radio frequency energy, microwave energy, ultrasonic energy, resistance heating, exothermic chemical reaction, or a combination thereof.

12. The apparatus according to any one of claims 1-2, wherein, The device further includes: A cryogenic fluid source, said cryogenic fluid source being at least partially positioned in the handle; and A lumen is disposed in the probe shaft and is in fluid communication with the cryogenic fluid source.

13. The apparatus of claim 12, wherein, The height of the cryogenic fluid source is less than about 2 cm above the longitudinal axis of the proximal portion of the probe shaft.

14. The apparatus of claim 12, wherein, The cryogenic fluid source includes a can that is detachably and at least partially positioned in the handle.

15. The apparatus of claim 12, wherein, The angle between the longitudinal axis of the cryogenic fluid source and the longitudinal axis of the proximal portion of the probe shaft is approximately 60 degrees to approximately 90 degrees.

16. The apparatus of claim 12, wherein, The end effector includes: A planar member defining a flat shape disposed at the distal end of the probe axis, the planar member having an elongated structure with curved edges to define the wound-resistant surface; and An expandable structure surrounds the planar member and is coupled to the distal end of the probe shaft, wherein the expandable structure is capable of expanding from a collapsed configuration to an expanded configuration, and the interior of the expandable structure is in fluid communication with the cryogenic fluid source.

17. The apparatus of claim 16, wherein, The expandable structure is configured to expand to a predetermined shape and size in the expansion configuration, and the predetermined shape and size correspond to the shape and size of the nasal tissue region.

18. The apparatus of claim 16, wherein, The expandable structure is configured to change from the collapsed configuration to the expanded configuration once the cryogenic fluid inside the expandable structure evaporates.

19. The apparatus of claim 16, wherein, The planar member includes an elongated ring structure formed of rigid wires configured to manipulate tissues in the nasal cavity.

20. The apparatus of claim 16, wherein, The expandable structure has an expansion diameter of 3 mm to 12 mm.

21. The apparatus of claim 16, wherein, The planar member extends within the expandable structure such that it is not attached to the interior of the expandable structure.

22. The apparatus of claim 16, wherein, The device is configured to cool the outer surface of the expandable structure to -20°C to -90°C for less than 120 seconds in order to controllably freeze the at least one nasal nerve at a depth of less than 4 mm from the surface of the nasal tissue region, thereby reducing at least one rhinitis symptom in the patient.

23. The apparatus of claim 1, wherein, The device also includes a cryogenic fluid source coupled to the handle, the longitudinal axis of the cryogenic fluid source defining an angle with the longitudinal axis of the proximal portion of the probe shaft, the angle being configured to allow cryogenic fluid to flow from the cryogenic fluid source to the end effector when the patient is sitting upright and when the patient is prone.

24. The apparatus of claim 1, wherein, The trigger includes: A switching valve, configured to be pressed down from an initial position toward the handle, such that cryogenic fluid flows through the probe shaft into the end effector; and A locking lever, which is biased toward the switching valve by a biasing force. Specifically, in response to pressing the switching valve towards the handle from the initial position, the locking lever prevents the switching valve from returning to the initial position. The locking lever is able to move against the bias force so that the switching valve returns to the initial position.

25. The apparatus of claim 24, wherein, The switching valve and the locking lever can be operated with one hand while holding the handle with a pistol grip.

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