The present disclosure is related to devices and methods for treating regions of tissue. More particularly, the present disclosure is related to devices and methods for treating regions of tissue such as through cryotherapies including hypothermic cooling and cryogenic ablation for treating ear, nose, and throat (ENT) afflictions such as rhinitis.
Unless otherwise indicated herein, the materials described in this section are not prior art to the claims in this application and are not admitted to be prior art by inclusion in this section.
The human nose is responsible for warming, humidifying, and filtering inspired air. The nose is mainly formed of cartilage, bone, mucous membranes, and skin. The right and left nasal cavities extend posteriorly to the soft palate, where they merge to form the posterior choanae. The posterior choanae opens into the nasopharynx. The roof of the nose is formed, in part, by a bone known as the cribriform plate. The cribriform plate contains numerous tiny perforations through which sensory nerve fibers extend to the olfactory bulbs. The sensation for smell occurs when inhaled odors contact a small area of mucosa in the superior region of the nose, stimulating the nerve fibers that lead to the olfactory bulbs.
The nasal turbinates are three bony processes that extend medially from the lateral walls of the nose and are covered with mucosal tissue. These turbinates serve to increase the interior surface area of the nose and to impart warmth and moisture to air that is inhaled through the nose. The mucosal tissue that covers the turbinates is capable of becoming engorged with blood and swelling, or becoming substantially devoid of blood and shrinking, in response to changes in physiologic or environmental conditions. The curved edge of each turbinate defines a passage way known as a meatus. For example, the inferior meatus is a passageway that passes beneath the inferior turbinate. Ducts, known as the nasolacrimal ducts, drain tears from the eyes into the nose through openings located within the inferior meatus. The middle meatus is a passageway that is lateral to the middle turbinate, inferior to its attachment to the lateral wall. The middle meatus contains the semilunar hiatus, with openings or ostia leading into the maxillary, frontal, and anterior ethmoid sinuses. The superior meatus is located between the superior and middle turbinates.
The turbinates are autonomic ally innervated by nerves arising from the vidian nerve. The vidian nerve contains sympathetic and parasympathetic afferents that can modulate the function of the soft tissue covering the turbinates to either increase (parasympathetic) or decrease (sympathetic) the activity of the submucosal layer. The vidian nerve travels to the sphenopalatine ganglion via the pterygoid canal. Some of the fibers from the sphenopalatine ganglion (SPG) enter the nasal cavity through the sphenopalatine foramen (SPF). Exclusive of the SPF, additional posterolateral neurovascular rami project from the SPG to supply the nasal mucosa. The most common locations for these rami are within 1 cm posterosuperior to the horizontal attachment of the inferior turbinate, within 5 mm anteroinferior to this attachment, and proximate to the palatine bone via a foramen distinct from the SPF. Interfascicle anastomotic loops are, in some cases, associated with at least three accessory nerves. Each accessory nerve could be traced directly to the SPG or the greater palatine nerve.
Rhinitis is defined as inflammation of the membranes lining the nose, characterized by nasal symptoms including itching, rhinorrhea, and/or nasal congestion. Chronic rhinitis affects millions of people and is a leading cause for patients to seek medical care. Medical treatment has been shown to have limited effects for chronic rhinitis sufferers and requires daily medication use or onerous allergy treatments, and up to 20% of patients may be refractory.
In addition to the existing medications, turbinate reduction surgery (e.g., radiofrequency-based and micro-debridement-based surgeries) has been shown to have a temporary duration of effect of 1-2 years, and can result in complications including mucosal sloughing, acute pain and swelling, overtreatment, and bone damage. Additionally, turbinate reduction surgery does not treat the symptom of rhinorrhea.
It is thought that parasympathetic effect of the vidian nerve predominately controls autonomic balance, and accordingly transecting it may result in decreased rhinitis and congestion. This pathophysiology has been confirmed as surgical treatment of the vidian nerve has indeed shown a reduction in some rhinitis symptoms; however, the procedure is invasive, time consuming, and potentially can result in chronic dry eyes because the autonomic fibers in the vidian nerve also supply the lacrimal glands.
Thermal therapies may represent a solution to the above limitations of prior treatments of ENT afflictions such as rhinitis. This class of therapies treats tissues by inducing temperature changes that selectively create tissue alterations, sometimes causing temporary or permanent damage. Depending on the type of tissue and the region of the body targeted for treatment, the application of thermal energy may provide various benefits, including treatment of cardiac arrhythmia, destruction of cancerous tissue masses, and alteration of nerve signaling pathways. Tissue ablation refers to a class of thermal therapies that causes destructive tissue damage. This damage may be induced via the application of heat (for example, with radiofrequency, laser, microwave, high intensity focused ultrasound (HIFU), or resistive heating methods) or via the application of cooling energy (for example, using cryoablation methods).
The term “cryotherapy” describes a class of thermal therapies that involve inducing cool or cold temperatures in body tissues, and includes the therapies generally referred to as therapeutic hypothermia and cryoablation. Depending on the temperatures and exposure times involved, the clinical goals of various cryotherapies may range from improved tissue healing/recovery (for example, as with therapeutic hypothermia employed during physical therapy sessions) to selective tissue damage or destruction (for example, during cryoablation used for neuromodulation or tumor-destruction purposes). Any tissue damage introduced during cryotherapy may be temporary or permanent, depending on the tissues treated and the characteristics of the therapy delivered.
Various cryotherapy techniques have recently been gaining in popularity for use in ENT procedures. Applications include treatments for rhinitis, enlarged turbinates, and other clinical pathologies. Modern cryotherapy for ENT is often delivered by using a compressed cryogen liquid (such as nitrous oxide) that provides a source of cooling as it expands into a gas during a transition to atmospheric pressure. This method for delivering a cold therapy eliminates the need for the complicated systems that are generally associated with thermoelectric/Peltier effect cooling and circulating fluid-based cooling, for example the need for pumps, wires, and/or other electrical hardware.
Accompanying the recent surge in popularity of cryotherapy for ENT applications, the devices, systems, and methods for delivery of cryotherapy for ENT have evolved and improved as well. Some advances in equipment and technique are geared towards improvements in medical outcomes, while others are related to either business or practical objectives. For example, ENT procedures are increasingly being delivered in outpatient office-based settings, and equipment and techniques utilized in this milieu may differ considerably from what is considered practical and safe for use within a hospital. However, even with these recent technological advances, some limitations remain with existing state-of-the-art cryotherapy equipment.
As such, the field of cryotherapy for ENT applications would be meaningfully improved if existing limitations known to those who are skilled in the art, were addressed with practical and cost-efficient solutions. Continuing to improve cryotherapy and other thermal therapy devices and techniques would enable more physicians to carry out procedures, more patients to receive procedures, and for patients who receive procedures to experience better outcomes.
The present disclosure is related to systems, devices, and methods for delivering cryotherapy interventions. More specifically, the present disclosure relates to delivering cryotherapy interventions for ENT afflictions. The present disclosure can be particularly useful when treating patients during office-based procedures, or in other situations where general anesthesia is not available, practical, and/or advisable. The present disclosure can be particularly useful during cryotherapy procedures applied within the upper airway.
The present disclosure provides methods, devices, and systems that advance the delivery of cryotherapy with solutions that improve the balance between simplicity, practicality, and effectiveness. More specifically, the systems, the devices, and/or the methods of the present disclosure allow for cryotherapy to be delivered in an improved way in the nasal cavity or other body lumens. Accomplishing this is valuable because it will improve the patient experience when receiving these important treatments which may encourage more patients to elect to receive said treatments.
In one example, the present 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 a longitudinal axis of a distal portion of the probe shaft has a non-zero angle with respect to a longitudinal axis of a proximal portion of the probe shaft. A flexibility of the proximal portion of the probe shaft is greater than a flexibility of the distal portion of the probe shaft. 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. The end effector defines an atraumatic surface when the distal end of the probe shaft is advanced through a nasal cavity of a patient and is positioned proximate to a nasal tissue region having at least one nasal nerve, and the end effector is configured to transmit lateral pressure against the nasal tissue region. The device also includes a trigger positioned in the handle. Activation of the trigger causes the end effector to ablate the at least one nasal nerve when the end effector is in contact against the nasal tissue region.
In another example, the present 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 a distal portion of the probe shaft and a proximal portion of the probe shaft such that a longitudinal axis of a distal portion of the probe shaft has a non-zero angle with respect to a longitudinal axis of a 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 that is greater than the first diameter such that an air gap separates the first tube and the second tube. 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. The end effector defines an atraumatic surface when the distal end of the probe shaft is advanced through a nasal cavity of a patient and is positioned proximate to a nasal tissue region having at least one nasal nerve. The end effector is configured to transmit lateral pressure against the nasal tissue region. The device also includes a trigger positioned in the handle. Activation of the trigger causes the end effector to ablate the at least one nasal nerve when the end effector is in contact against the nasal tissue region.
In yet another example, the present disclosure provides a method for treating a nasal tissue region of a nasal cavity of a patient. 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 with a first configuration having a low-profile which is shaped to manipulate tissue within the nasal cavity. The probe shaft has a curved portion such that a longitudinal axis of a distal portion of the probe shaft has a non-zero angle with respect to a longitudinal axis of a proximal portion of the probe shaft. A flexibility of the proximal portion of the probe shaft is greater than a flexibility of the distal portion of the probe shaft. The method also includes reconfiguring the end effector from the first configuration to a second configuration in which the end effector is shaped to contact and follow a contour of the nasal tissue region. The method also includes ablating, via the end effector, at least one nasal nerve of the nasal tissue region.
These as well as other aspects, advantages, and alternatives, will become apparent to those of ordinary skill in the art by reading the following detailed description, with reference where appropriate to the accompanying drawings.
Example methods and systems are described herein. It should be understood that the words “example,” “exemplary,” and “illustrative” are used herein to mean “serving as an example, instance, or illustration.” Any example or feature described herein as being an “example,” being “exemplary,” or being “illustrative” is not necessarily to be construed as preferred or advantageous over other examples or features. The examples described herein are not meant to be limiting. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are explicitly contemplated herein.
Furthermore, the particular arrangements shown in the Figures should not be viewed as limiting. It should be understood that other examples may include more or less of each element shown in a given Figure. Further, some of the illustrated elements may be combined or omitted. Yet further, an example may include elements that are not illustrated in the Figures.
In the following description, numerous specific details are set forth to provide a thorough understanding of the disclosed concepts, which may be practiced without some or all of these particulars. In other instances, details of known devices and/or processes have been omitted to avoid unnecessarily obscuring the disclosure. While some concepts will be described in conjunction with specific examples, it will be understood that these examples are not intended to be limiting.
Unless otherwise indicated, the terms “first,” “second,” etc. are used herein merely as labels, and are not intended to impose ordinal, positional, or hierarchical requirements on the items to which these terms refer. Moreover, reference to, e.g., a “second” item does not require or preclude the existence of, e.g., a “first” or lower-numbered item, and/or, e.g., a “third” or higher-numbered item.
As used herein, a system, apparatus, structure, article, element, component, or hardware “configured to” perform a specified function is indeed capable of performing the specified function without any alteration, rather than merely having potential to perform the specified function after further modification. In other words, the system, apparatus, 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 to” denotes existing characteristics of a system, apparatus, structure, article, element, component, or hardware which enable the system, apparatus, structure, article, element, component, or hardware to perform the specified function without further modification. For purposes of this disclosure, a system, apparatus, structure, article, element, component, or hardware described as being “configured to” perform a particular function may additionally or alternatively be described as being “adapted to” and/or as being “operative to” perform that function.
The limitations of the following claims are not written in means-plus-function format and are not intended to be interpreted based on 35 U.S.C. § 112(f), unless and until such claim limitations expressly use the phrase “means for” followed by a statement of function void of further structure.
By the term “about,” “approximately,” or “substantially” with reference to amounts or measurement values described herein, it is meant that the recited characteristic, parameter, or value need not be achieved exactly, but that deviations or variations, including for example, tolerances, measurement error, measurement accuracy limitations and other factors known to those of skill in the art, may occur in amounts that do not preclude the effect the characteristic was intended to provide.
Illustrative, non-exhaustive examples, which may or may not be claimed, of the subject matter according the present disclosure are provided below.
The present disclosure is related to systems, devices, and methods for applying cryotherapy. More specifically, the present disclosure relates to applying cryotherapy for applications related to afflictions of the ear, nose, and throat. The devices and methods described herein can be particularly useful when delivering treatments to patients in an office-based setting. Use of the disclosed methods, devices, and systems can allow for improved delivery of cryotherapy treatments with more effectiveness and practicality relative to existing equipment and techniques.
Various aspects of the present disclosure described herein may be applied to any of the particular applications set forth below or for any other types of thermal or non-thermal treatment systems or methods. The present disclosure may be applied as a standalone system or method, or as part of an integrated medical treatment system.
Generally, the present disclosure seeks to improve at least some aspects of existing cryotherapy devices. The improvements described can enable better outcomes, more practical usage, and will ultimately benefit both patients and care providers.
With reference to the Figures,
As shown in
The device 100 also includes an end effector 122 coupled to the distal end 104 of the probe shaft 102. In general, the end effector 122 is configured to ablate a target tissue adjacent to the end effector 122. For example, the end effector 122 can be configured to ablate at least one nasal nerve using cryogenic fluid (e.g., the end effector 122 can include a cryo-ablation element), radiofrequency (RF) energy, microwave energy, ultrasound energy, resistive heating, exothermic chemical reactions, or combinations thereof. Although the end effector 122 is described below for an implementation in which end effector 122 is configured to ablate the target tissue region using a cryogenic fluid, the end effector 122 can additionally or alternatively be configured to ablate the target tissue using one or more of the other ablation modalities described above. Additionally, the end effector 122 is shown having, multiple variations described herein and may be optionally interchanged depending upon which particular example utilized by a practitioner.
The end effector 122 can define an atraumatic surface when the distal end 104 of the probe shaft 102 is advanced through a nasal cavity of a patient and is positioned proximate to a nasal tissue region having at least one nasal nerve, for example the nasal nerve(s) associated with a lateral nasal wall. For example, the atraumatic surface of the end effector 122 can have a rounded and/or blunt edge, and omit pointed corners or sharp edges. To help define the atraumatic surface, the end effector 122 can additionally or alternatively be formed from a compliant material that can conform to a shape of anatomical structures contacted by the end effector 122 as the end effector 122 traverses through the nasal cavity. As examples, the end effector 122 can be formed, at least in part, from at least one material selected from among a group of materials including silicone rubber, a urethane rubber, nylon, and/or a polymeric material (e.g., polyethylene terephthalate (PET)).
Once positioned within the nasal tissue region, the end effector 122 is configured to transmit lateral pressure against the nasal tissue region. For example, the device 100 may be configured so that the practitioner can press the end effector 122 against the lateral nasal wall proximate to the target posterior nasal nerve. In some implementations, the end effector 122 can be configured to conform to the morphology of the target tissue (e.g., the lateral nasal wall) and to more evenly engage the target tissue (e.g., the lateral nasal wall) with a substantially uniform contact pressure as 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, thus, ablate the target tissue region in a more predictable and controllable manner to achieve a desired clinical outcome.
In one example, the probe shaft 102 may have a length between approximately 4 cm and approximately 10 cm, and a diameter between approximately 1 mm and approximately 4 mm. In some examples, the end effector 122 may have an outer diameter that approximates the diameter of the probe shaft 102. In other examples, the diameter of the end effector 122 may be larger or smaller than the diameter of the probe shaft 102. Additionally, in an example, the extended length of the end effector 122 may be between approximately 0.5 cm and approximately 1.5 cm. The end effector 122 can be substantially flexible along a longitudinal axis of the end effector 122 (e.g., along the axis 110); however, the end effector 122 may also be at least partly malleable and configured for form shaping, by the user. Form shaping of the end effector 122 may be performed manually by the practitioner. Various lengths, shapes, and diameters of the end effector 122 of the device 100 may be produced and supplied to the end user.
Within examples, the end effector 122 can be additionally or alternatively configured to transmit the lateral pressure against the nasal tissue region based on at least one feature selected from among a group of features including: (i) the probe shaft 102 having the curved portion 108 such that the longitudinal axis 110 of the distal portion 112 of the probe shaft 102 has a non-zero angle with respect to the longitudinal axis 116 of the proximal portion 118 of the probe shaft 102, and (ii) the flexibility of the proximal portion 118 of the probe shaft 102 being greater than a flexibility of the distal portion 112 of the probe shaft 102.
For instance, due to the curved portion 108, the proximal portion 118 of the probe shaft 102 can allow the end effector 122 to contact and applanate against the nasal tissue region of interest while the proximal portion 118 of the probe shaft 102 applies negligible or no pressure against other anatomical features of the nasal cavity. As shown in
In one implementation of the device 100, as shown in
Additionally, as noted above, the flexibility of the proximal portion 118 of the probe shaft 102 can be greater than a flexibility of the distal portion 112 of the probe shaft 102. This difference in flexibility between the proximal portion 118 of the probe shaft 102 and the distal portion 112 of the probe shaft 102 can provide a flexing location of the probe shaft 102 at a location between the proximal portion 118 and the distal portion 112 (e.g., at the curved portion 108 of the probe shaft 102) when the end effector 122 engages the target tissue region. The flexing location between the proximal portion 118 and the distal portion 112 can be more proximally located along the probe shaft 102 than a flexing location of the probe shaft 102 in implementations in which the probe shaft 102 does not have a difference in flexibility between the proximal portion 118 and the distal portion 112. Providing the flexing location more proximally along the probe shaft 102 can allow for a relatively large portion (e.g., greater than 50 percent) or an entirety of a tissue-facing surface of the end effector 122 to more evenly contact a surface of a target tissue (e.g., the lateral nasal wall) when a practitioner manipulates the handle 120 in a direction towards the target tissue, as compared to implementations in which the probe shaft 102 has substantially the same flexibility over an entire length of the probe shaft 102.
Within examples, to provide the difference in flexibility 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 can (i) be formed from different material(s) and/or (ii) have different dimensions. For instance, the proximal portion 118 can be formed from one or more rigid materials selected from among: metal tubing (ie stainless steel tubing), polymeric/plastic tubing (ie PEEK, Nylon, ABS, Urethane, polyethylene), and woven/braided tubing. The distal portion 112 each can be formed from one or more materials selected from among: a thermoplastic elastomer (e.g., polyether block amide also known as PEBAX), nylon, urethane, polyethylene, polyether ether ketone (PEEK), polytetrafluoroethylene (PTFE), laser cut metal tubing, metal coiling material, and mesh/braided shaft material. Additionally, for instance, the one or more materials selected for the proximal portion 118 can be different than the one or more materials selected for the distal portion 112.
In one example, the distal portion 112 of the probe shaft 102 can have a flexibility that is approximately two times to approximately four times greater than a flexibility of the proximal portion 118 of the probe shaft 102. In an implementation, the distal portion 112 can have a respective hardness value selected from a range of values between approximately 35 Shore D and approximately 72 Shore D.
Additionally, in an example, the distal portion 112 of the probe shaft 102 can have respective stiffness and/or flexibility values such that a 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 can be between 0.3 pounds and approximately 0.7 pounds. In another example, the distal portion 112 of the probe shaft 102 of the probe shaft 102 can have respective stiffness and/or flexibility values such that a 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 can be between 0.6 pounds and approximately 0.7 pounds. In another example, the distal portion 112 of the probe shaft 102 can have respective stiffness and/or flexibility values such that a 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 can be between 0.3 pounds and approximately 0.5 pounds.
The probe shaft 102 may be configured to be rotatably coupled to the housing 119 of the device 100 to facilitate positioning of the end effector 122 without having to rotate the device 100 excessively. In one example, the probe shaft 102 is rotatable 180 degrees with respect to the housing 119 of the device 100. As such, 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 may be adjustable from angling to the left when looking at the device 100 from a top view, to angling to the right when looking at the device 100 from a top view. For example, during use the practitioner may insert the end effector 122 of the device 100 and ablate a target nasal nerve in the left nostril of the patient, remove the device from the patient's nasal cavity, rotate the probe shaft 102 180 degrees, and then insert the end effector 122 of the device 100 and ablate a target nasal nerve in the right nostril of the patient without modifying the practitioner's grip on the handle 120.
In one particular example, the housing 119 of the device 100 just proximal to the proximal end 106 of the probe shaft 102 may include a pair of detents and a corresponding pair of cutouts. The pair of detents may be positioned approximately 180 degrees apart, and the corresponding pair of cutouts may also be positioned approximately 180 degrees apart. In a first configuration (e.g., a configuration in which the probe shaft 102 angles to the left when looking at the device 100 from a top view), a first detent of the pair of detents is positioned in a first cutout of the pair of cutouts, and a second detent of the pair of detents is positioned in a second cutout of the pair of cutouts. Upon rotation of the probe shaft 102, the pair of detents may be configured to rotate with respect to the pair of cutouts until the device 100 is in a second configuration. In the second configuration, (e.g., a configuration in which the probe shaft 102 angles to the right when looking at the device 100 from a top view), the first detent is positioned in the second cutout, and the second detent is positioned in the first cutout.
The device 100 also includes a trigger 124 positioned in the handle 120. Activation of the trigger 124 causes the end effector 122 to ablate the at least one nasal nerve in the nasal tissue when the end effector 122 is in contact against the nasal tissue region. The at least one nasal nerve of the nasal tissue region can include one or more of a posterior nasal nerve of a nasal branch of a vidian nerve, as a non-limiting example. In another example, the distal end 104 of the probe shaft 102 is advanced through the nasal cavity of the patient and in proximity of a sphenopalatine foramen. As noted above, the difference in flexibility between the proximal portion 118 of the probe shaft 102 and the distal portion 112 of the probe shaft 102 causes a flexing location of the probe shaft 102 to shift to a more proximal location on the device 100, allowing the end effector 122 to lay against a flat surface such as the lateral nasal wall as described above. This difference in flexibility additionally or alternatively enables the device 100 to accommodate a larger range of anatomies without requiring the operator to apply inappropriately large tissue forces in order to establish proper tissue contact.
As noted above, the end effector 122 can be configured to ablate the at least one nasal nerve using at least one ablation modality selected from among a group of modalities including: cryogenic fluid (e.g., a cryo-ablation element), RF energy, microwave energy, ultrasound energy, resistive heating, exothermic chemical reactions, or combinations thereof. In one example, the device 100 includes a cryogenic fluid source 126 positioned at least partially in the handle 120, and a lumen disposed in the probe shaft 102 and in fluid communication with the cryogenic fluid source 126. In one example, the cryogenic fluid source 126 may be supplied with liquid cryogen and configured for a single patient use.
Alternatively, the device 100 may be configured for use with a user replaceable cryogenic fluid source 126 in the form of a canister that is removably positioned at least partially in the handle 120. Such an example canister is illustrated in
In addition, as shown in
With reference to
Additionally, in
In some implementations, the practitioner may apply approximately four pounds of force to depress the toggle valve 134 and cause the cryogenic fluid to flow to the end effector 122. During some procedures, the practitioner may maintain this force on the toggle valve 134 for approximately 30 seconds for each nostril of a given patient, and may perform this procedure on multiple patients in a given day. Accordingly, the lockout lever 136 can help to mitigate fatigue on the fingers of the practitioner operating the device 100 by allowing the cryogenic fluid to continue to flow without the practitioner maintaining the force on the toggle valve 134 for an entirety of the procedure. Although the lockout lever 136 can provide such benefits, the device 100 can omit the lockout lever 135 in some alternative implementations.
In examples, the toggle valve 134 and lockout lever 136 are located proximate to handle 120 in a position such that all adult operators are expected to be able to reach the toggle valve 134 with a finger on the same hand which grips the handle 120. As a result of these improvements over existing devices, the presently-disclosed device 100 can now be suitably operated with a single hand. As such, the device 100 may be configured so that it is held by the user like a pistol having a pistol grip where the toggle valve 134 is configured like a pistol trigger. Other example arrangements are possible as well.
As shown in
The pressurized cryogenic fluid source 126 may contain a liquid cryogen, e.g., nitrous oxide, but may also be another cryogenic liquid such as liquid carbon dioxide, or a liquid chlorofluorocarbon compound, etc. In use, liquid cryogen is introduced into the end effector 122 through a liquid cryogen supply line that is connected to the cryogenic fluid source 126 in the handle 120, and runs coaxially through the probe shaft 102. The end effector 122 is configured as a liquid cryogen evaporator, and is configured to be pressed against the lateral nasal wall proximate to the SPF as described above for cryo-ablation of at least one posterior nasal nerve. The construction and the function of the end effector 122, and alternative examples are described in detail below. The evaporated liquid cryogen may be vented to the room, e.g., through the probe shaft 102 to one or more vent ports 138 in the handle 120 (shown in
In one example of the present disclosure, as shown in
The expandable structure 144 may be formed from an elastomeric material such as silicone rubber, or a urethane rubber. Alternatively, the expandable structure 144 may be formed from a substantially non-elastomeric material such as nylon or PET. In an example, the expandable structure 144 is configured to expand to a predetermined shape and size in the expanded configuration, and the predetermined shape and size corresponds to a shape and size of the nasal tissue region to be targeted for treatment. For instance, the expandable structure 144 is configured so the shape and the size of the structure matches the shape and the size of the cul-de-sac of the middle meatus defined by the tail of the middle turbinate, the middle turbinate, the lateral nasal wall, and the inferior turbinate, which is an example target location for the ablation of the posterior nasal nerves for the treatment of rhinitis. Matching the size and shape of the expandable structure 144 to the size and shape of the target anatomy facilitates improved tissue freezing and ablation of posterior nasal nerves. The expandable structure 144 may have an expanded diameter between approximately 3 mm and 12 mm in one radial axis, and may be configured such that the expanded diameter in one radial axis is different than another radial axis. The planar member 142 may include an elongate loop structure formed by a rigid wire that is configured to manipulate tissue in the nasal cavity. Further, the planar member 142 may be coupled to the distal end 104 of the probe shaft 102 within such that the planar member 142 is unattached to an interior of the expandable structure 144. In use, the device 100 is configured to cool an external surface of the expandable structure 144 to between −20 degrees Celsius (C) to −90 degrees C. for less than 120 seconds so as to controllably freeze the at least one nasal nerve at a depth less than 4 mm from a surface of the lateral nasal wall tissue region so as to reduce at least one symptom of rhinitis of the patient.
In some examples of the present device 100, the planar member 142 can assume a wide shape that tracks the perimeter of the expandable structure 144. Also, in some examples, the planar member 142 can couple to the probe shaft 102 approximately 15 mm proximal to the expandable structure 144. As illustrated in
Preferred implementations of such an insulated system may utilize hypotubes comprised of stainless steel or other similar materials. Stainless steel provides sufficient mechanical strength while simultaneously allowing for a minimal thickness of the tube wall. Limiting the thickness of the tube wall enables the size of the air gaps between adjacent tubes to be maximized, thus maximizing insulation. In one example, the inner first tube 162 may have an inner diameter of approximately 0.046 inches with an outer diameter of approximately 0.056 inches. An inner diameter of this size ensures sufficient area for cryogen exhaust to flow through the internal tube lumen in order to achieve a desired pressure within the end effector 122. An outer diameter of this size may help 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 with an outer diameter of approximately 0.095 inches. The outer second tube 164 outer diameter of the size described minimizes the profile of the probe shaft 102 for navigation within the nasal cavity, with the inner diameter of this outer second tube 164 again selected in order to prevent kinking of the tube. In the example described, the resulting air pocket for insulation is approximately 0.014-0.015 inches. In preferred implementations, the first tube 162 and the second tube 164 are centered at the distal and proximal edges. A material such as stainless steel provides the additional benefit of ensuring that the first tube 162 and the second tube 164 maintain their relative spacing separation, thus maximizing insulation and preventing cold spots.
The probe shaft 102 may be fabricated from various biocompatible materials. In one example, the distal portion 112 of the probe shaft 102 comprises a first material, and the proximal portion 118 of the probe shaft 102 comprises a second material that is different than the first material. In one example, the first material comprises a polymer, and the second material comprises stainless steel. Such a difference in material may provide the difference in flexibility between the proximal portion 118 of the probe shaft 102 and the distal portion 112 of the probe shaft 102, as discussed in additional detail below.
In particular,
In examples of the presently-disclosed device 100, the planar member 142 may be constructed of stainless steel wire having a diameter range of about 0.010 to about 0.020 inches, with a preferred diameter of 0.015 inches. In examples, the wire is shaped so as to ensure the wire doesn't obstruct the cryogen spray emerging from the probe shaft 102 and so that the wire is narrowed proximal of the planar member 142 so as to minimize the profile of the structure. The shape of the planar member 142 shown in
In examples of the presently-disclosed device 100, the wire legs of the planar member 142 may be inserted into a tube, for example a three-lumen polymer tube 166. Each leg may insert into an independent lumen that is sized appropriately to provide a tight fit around the wire. In examples, the central lumen may remain open to be employed for other device purposes, such as an exhaust lumen for evaporated cryogen material. In variation examples, the polymer tube 166 may contain fewer than three or greater than three lumens. In some examples, the polymer tube 166 is placed such that its distal end touches the proximal end of the planar member 142. The polymer tube 166 is preferably constructed of a thermoplastic elastomer having a hardness in the range of 40-80 shore D or another suitable polymer material that retains appropriate flexibility while maintaining an ability to be thermally-processed and attached to similar materials. In preferable examples, the polymer tube 166 has a length of approximately 20 mm. In one example, during device construction, the proximal end of the central lumen of the polymer tube 166 is pressed onto a curved rigid proximal portion 118 of the probe shaft 102 so that the polymer tube 166 overlaps the proximal portion 118 of the probe shaft 102 between about 2 mm to about 7 mm. The wire legs of the planar member 142 may then be affixed to the probe shaft 102 via laser welding or a similar technique. In examples, an inner first tube 162 runs the entire length of the probe shaft 102 and is affixed to a larger outer second tube 164 inside the handle 120. As discussed above, this construction allows for a 10-15 mm flexible and incompressible device neck that retains a sealed inner lumen for cryogen exhaust.
The presence of the polymer tube 166 at the distal end 104 of the probe shaft 102 results in an unexpectedly large reduction in force needed to position the planar member 142 flush against a flat surface. In particular, presently-disclosed device may require less than 4 ounces of force to position the planar member 142 flat on a surface, and preferably less than about 2 ounces of force. With the incorporation of the novel design aspects disclosed herein, the flexing location of the probe shaft 102 shifts to a more proximal location on the device 100, allowing the entire planar member 142 to lay against a flat surface such as the lateral nasal wall. This enables the device 100 to accommodate a larger range of anatomies without requiring the operator to apply inappropriately large tissue forces in order to establish proper tissue contact.
Additional examples of exemplary devices are described below. The features of any of the devices or device components described in any of the examples herein can be used in any other suitable example of a device or device component. In one example, the present disclosure provides a surgical probe which is configured for ablation where the surgical probe includes a surgical probe shaft comprising an elongated structure with a distal end and a proximal end, an expandable structure attached to the distal end of the probe shaft, the expandable structure having a deflated configuration and an expanded configuration, a member attached to the distal end and extending within the expandable structure such that the member is unattached to an interior of the expandable structure, wherein the member defines a flattened shape which is sized for placement against a lateral nasal wall proximate to a posterior nasal nerve, and a lumen in fluid communication with the interior of the expandable structure.
The device 100 may be configured as a simple mechanical device that is void of electronics as shown. Alternatively, device 100 may be configured with at least one electronic function. In one example, a temperature sensor may be disposed in the vicinity of the end effector 122. As examples,
In
In
In
In
As described above, in some examples of the device 100 shown in
The trigger 124 may also optionally include a servo mechanism configured to respond to a sensed temperature to modulate the flow of cryogen in order to control a desired surgical parameter. In particular, the device 100 may be configured to automatically adjust the flow rate of liquid cryogen in response to one or more of the following parameters: evaporator temperature, evaporator pressure, tissue temperature, evaporator exhaust gas temperature, or elapsed cryogen flow time. The flow rate may be adjusted in a continuous analog manner, and/or by an alternating on/off flow modulation.
In addition to a temperature sensing capability, the device 100 may be configured with a camera and/or a light source disposed in the vicinity of the distal end 104 of probe shaft 102. The camera and/or the light source may be used, e.g., to identify nasal anatomical landmarks, and may be used to guide the placement of the end effector 122 against the lateral nasal wall for ablation of the function of a target posterior nasal nerve.
An ultrasonic or optical Doppler flow sensor may also be disposed in the vicinity of distal end 104 of probe shaft 102 and be used, e.g., to locate an artery associated with the target posterior nasal nerve, as a means for locating the target posterior nasal nerve. In one such example, the Doppler flow sensor includes an ultrasound detector. In another such example, the Doppler flow sensor includes an optical detector. In one example, the artery associated with the at least one nasal nerve includes an artery from a sphenopalatine branch.
Although
In addition, one or more electrodes may be disposed in the vicinity of the distal end 104 of probe shaft 102, which may be used for electrical stimulation or electrical blockade of the function of a target posterior nasal nerve using the observed physiological response to the stimulation or blockade to confirm correct surgical positioning of the end effector 122 prior to ablation and/or to confirm effectiveness of ablation by the determination of a change in the physiological response from before and after ablation.
Although
Any number of temperature sensing, endoscopic instruments, servo controlled cryogen control valves, ultrasonic or optical Doppler flow detection, and/or electrical nervous stimulation and blockade mechanisms may be optionally incorporated into the devices described herein.
In use, such a surgical probe may be used for treating a tissue region within a nasal cavity, generally comprising advancing a distal end of a surgical probe shaft through the nasal cavity and into proximity of the tissue region having a nasal nerve, introducing a cryogenic liquid into an expandable structure attached to the distal end of the probe shaft such that the expandable structure inflates from a deflated configuration into an expanded configuration against the tissue region, positioning a member relative to the tissue region, wherein the member is attached to the distal end of the probe shaft and extends within the expandable structure such that the member is unattached to an interior of the expandable structure, and wherein the member defines a flattened shape which is sized for placement against the tissue region proximate to the nasal nerve, and maintaining the member against the tissue region until the nasal nerve is cryogenically ablated.
Another example of the present disclosure is a cryo-surgical probe apparatus for ablation of a nasal nerve comprising a handle at the proximal end, a probe shaft with a spatula shaped cryo-ablation element mounted in vicinity of the distal end of the shaft, whereby the handle is configured for housing a cryogen source, and controlling the flow of the cryogen to the cryo-ablation element, and the geometric parameters of the probe shaft and cryo-ablation element are configured for cryo-ablation of nasal mucosa containing the nasal nerve according to the methods disclosed here within.
Another example of the present disclosure is a cryo-surgical probe apparatus for ablation of nasal mucosa comprising a handle at the proximal end, a probe shaft with a bullet shaped cryo-ablation element mounted in vicinity of the distal end of the shaft, whereby the handle is configured for housing a cryogen source, and controlling the flow of the cryogen to the cryo-ablation element, and the geometric parameters of the probe shaft and cryo-ablation element are configured for cryo-ablation of the nasal mucosa according to the methods disclosed here within.
Another example of the present disclosure is a cryo-surgical probe apparatus for ablation of a nasal nerve comprising a handle at the proximal end, a probe shaft with a bullet shaped cryo-ablation element mounted in vicinity of the distal end of the shaft, whereby the handle is configured for housing a cryogen source, and controlling the flow of the cryogen to the cryo-ablation element, wherein the probe shaft is configured with user operable deflectable distal segment, and the geometric parameters of the probe shaft and cryo-ablation element are configured for cryo-ablation of the nasal nerve according to the methods disclosed here within.
Another example of the present disclosure is a cryo-surgical probe apparatus for ablation of a nasal nerve comprising a handle at the proximal end, a probe shaft with a cylindrically shaped cryo-ablation element mounted in vicinity of the distal end of the shaft, whereby the handle is configured for housing a cryogen source, and controlling the flow of the cryogen to the cryo-ablation element, wherein the cryo-ablation element includes a linear segmented cryo-ablation element, and the geometric parameters of the probe shaft and cryo-ablation element are configured for cryo-ablation of the nasal nerve according to the methods disclosed here within.
Another example of the present disclosure is a cryo-surgical probe apparatus for ablation of a nasal nerve comprising a handle at the proximal end, a probe shaft with a cylindrically shaped cryo-ablation element mounted in vicinity of the distal end of the shaft, whereby the handle is configured for housing a cryogen source, and controlling the flow of the cryogen to the cryo-ablation element, wherein the cryo-ablation element includes a semi-circular cryo-ablation element, and the geometric parameters of the probe shaft and cryo-ablation element are configured for cryo-ablation of target tissue containing the nasal nerve according to the methods disclosed here within.
Another example of the present disclosure is a cryo-surgical probe apparatus for ablation of a nasal nerve comprising a handle at the proximal end, a probe shaft with a cylindrically shaped cryo-ablation element mounted in vicinity of the distal end of the shaft, whereby the handle is configured for housing a cryogen source, and controlling the flow of the cryogen to the cryo-ablation element, wherein the cryo-ablation element includes a spiraled cryo-ablation element, and the geometric parameters of the probe shaft and cryo-ablation element are configured for cryo-ablation of target nasal tissue containing the nasal nerve according to the methods disclosed here within.
Another example of the present disclosure is a cryo-surgical probe apparatus for ablation of a nasal nerve comprising a proximal end, a probe shaft with a cryo-ablation element comprising a balloon mounted in vicinity of the distal end of the shaft, whereby the proximal end is configured for receiving a cryogen from a cryogen source with the cryogen source comprising a means controlling the flow of the cryogen to the cryo-ablation element, and the geometric parameters of the probe shaft and cryo-ablation element are configured for cryo-ablation of the nasal nerve according to the methods disclosed here within.
Another example of the present disclosure is a cryo-surgical probe apparatus for ablation of a nasal nerve comprising a handle at the proximal end, a probe shaft with a cylindrically shaped cryo-ablation element comprising a balloon mounted in vicinity of the distal end of the shaft, whereby the handle is configured for housing a cryogen source, and controlling the flow of the cryogen to the cryo-ablation element, and the geometric parameters of the probe shaft and cryo-ablation element are configured for cryo-ablation of target nasal tissue containing the nasal nerve according to the methods disclosed here within.
Another example of the present disclosure is a cryo-surgical probe apparatus for ablation of a nasal nerve comprising a handle at the proximal end, a probe shaft with a cylindrically shaped cryo-ablation element mounted comprising a balloon with two lateral chambers disposed in the vicinity of the distal end of the shaft, whereby the handle is configured for housing a cryogen source, and controlling the flow of the cryogen to the cryo-ablation 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 geometric parameters of the probe shaft and cryo-ablation element are configured for cryo-ablation of the nasal nerve according to the methods disclosed here within.
Another example of the present disclosure is a cryo-surgical probe apparatus for ablation of a nasal nerve comprising a handle at the proximal end, a probe shaft with a “I” shaped cryo-ablation element comprising a balloon mounted in vicinity of the distal end of the shaft, whereby the handle is configured for housing a cryogen source, and controlling the flow of the cryogen to the cryo-ablation element, and the geometric parameters of the probe shaft and cryo-ablation element are configured for cryo-ablation of the nasal nerve according to the methods disclosed here within.
Another example of the present disclosure is a cryo-surgical probe apparatus for ablation of a nasal nerve function comprising a handle at the proximal end, a probe shaft with a “J” shaped cryo-ablation element comprising a balloon mounted in vicinity of the distal end of the shaft, whereby the handle is configured for housing a cryogen source, and controlling the flow of the cryogen to the cryo-ablation element, and the geometric parameters of the probe shaft and cryo-ablation element are configured for cryo-ablation of the nasal nerve according to the methods disclosed here within.
Another example of the present disclosure is a cryo-surgical probe apparatus for ablation of a nasal nerve comprising a handle at the proximal end, a probe shaft with a cryo-ablation element mounted in vicinity of the distal end of the shaft, whereby the handle is configured for housing a cryogen source, and controlling the flow of the cryogen to the cryo-ablation element, wherein a suction means associated with the cryo-ablation element is configured for stabilizing the position of the cryo-ablation element against the target tissue, and the geometric parameters of the probe shaft and cryo-ablation element are configured for cryo-ablation of the nasal nerve according to the methods disclosed here within.
One aspect of the present disclosure is a method for cryo-surgical ablation of a nasal nerve comprising placing a film of oil or gel on the surface of a cryo-ablation element, then pressing the cryo-ablation element against the lateral wall of a nasal cavity adjacent to the nasal nerve, then ablating the nasal nerve with the cryo-ablation element, whereby the oil or gel prevents frozen nasal tissue from adhering to the cryo-ablation element.
Another aspect of the present disclosure is an electrosurgical probe apparatus for ablation of a nasal nerve comprising a handle at the proximal end, a probe shaft with a radiofrequency (RF) ablation element comprising at least one RF electrode mounted in the vicinity of the distal end of the shaft, an electrical connector in the vicinity of the handle configured to connect the RF ablation element to a source of radiofrequency energy, whereby the geometric parameters of the probe shaft and RF ablation element are configured for RF ablation of the nasal nerve according to the methods disclosed here within.
Another example of the present disclosure is an electrosurgical probe apparatus for ablation of a nasal nerve comprising a handle at the proximal end, a probe shaft with a RF ablation element comprising at least one RF electrode mounted in the vicinity of the distal end of the shaft, an electrical connector disposed in the vicinity of the handle configured to connect the RF ablation element to a source of radiofrequency energy, and a fluid connector disposed in the vicinity of the handle to connect at least one fluid port associated with the RF ablation element with a source of pressurized liquid, whereby the geometric parameters of the probe shaft and RF ablation element are configured for RF ablation of the nasal nerve according to the methods disclosed here within.
Another example of the present disclosure is an electrosurgical probe apparatus for ablation of a nasal nerve comprising a handle at the proximal end, a probe shaft with a RF ablation element comprising at least one RF electrode mounted in the vicinity of the distal end of the shaft, an electrical connector disposed in the vicinity of the handle configured to connect the RF ablation element to a source of radiofrequency energy, whereby the geometric parameters of the probe shaft and RF ablation element are configured for RF ablation of the nasal nerve according to the methods disclosed here within, wherein the RF ablation element includes a monopolar electrosurgical configuration comprising one or more electrodes.
Another example of the present disclosure is an electrosurgical probe apparatus for ablation of a nasal nerve comprising a handle at the proximal end, a probe shaft with a RF ablation element comprising at least one RF electrode mounted in the vicinity of the distal end of the shaft, an electrical connector disposed in the vicinity of the handle configured to connect the RF ablation element to a source of radiofrequency energy, whereby the geometric parameters of the probe shaft and RF ablation element are configured for RF ablation of the nasal nerve according to the methods disclosed here within, wherein the RF ablation element includes a bi-polar electrosurgical configuration comprising two or more electrodes.
Another example of the present disclosure is an electrosurgical probe apparatus for ablation of a nasal nerve comprising a handle at the proximal end, a probe shaft with a RF ablation element comprising at least one RF electrode mounted in the vicinity of the distal end of the shaft, an electrical connector disposed in the vicinity of the handle configured to connect the RF ablation element, to a source of radiofrequency energy, whereby the geometric parameters of the probe shaft and RF ablation element are configured for RF ablation of the nasal nerve according to the methods disclosed here within, wherein the RF ablation element is disposed in the vicinity of the distal end of the shaft on a cylindrical, “J” shaped, “U” shaped or “T” shaped structure.
Another example of the present disclosure is an electrosurgical probe apparatus for ablation of a nasal nerve comprising a handle at the proximal end, a probe shaft with a RF ablation element comprising at least one RF electrode mounted in the vicinity of the distal end of the shaft, an electrical connector disposed in the vicinity of the handle configured to connect the RF ablation element to a source of radiofrequency energy, whereby the geometric parameters of the probe shaft and RF ablation element are configured for RF ablation of the nasal nerve according to the methods disclosed here within, wherein the RF ablation element is configured in a lateral or radial arrangement.
Another example of the present disclosure is an electrosurgical probe apparatus for ablation of a nasal nerve comprising a handle at the proximal end, a probe shaft with a RF ablation element comprising at least one RF electrode mounted in the vicinity of the distal end of the shaft, an electrical connector disposed in the vicinity of the handle configured to connect the RF ablation element to a source of radiofrequency energy, whereby the geometric parameters of the probe shaft and RF ablation element are configured for RF ablation of the nasal nerve according, to the methods disclosed here within, wherein the RF ablation element includes a circular array of domed electrodes disposed on a flat electrically insulative surface, with the domed electrodes optionally associated with a fluid irrigation port.
Another example of the present disclosure is an electrosurgical probe for ablation of the a nasal nerve comprising a handle at the proximal end, a probe shaft with a RF ablation element comprising at least one RF electrode mounted in the vicinity of the distal end of the shaft, an electrical connector disposed in the vicinity of the handle configured to connect the RF ablation element to a source of radiofrequency energy, whereby the geometric parameters of the probe shaft and RF ablation element are configured for RF ablation of the nasal nerve according to the methods disclosed here within, wherein the RF ablation element includes a linear array of domed electrodes disposed on a flat electrically-insulative surface, with the domed electrodes optionally associated with a fluid irrigation port, and a needle configured for injecting a liquid into a sub-mucosal space.
Another example of the present disclosure is an electrosurgical probe apparatus for ablation of a nasal nerve comprising a handle at the proximal end, a probe shaft with a RF ablation element comprising at least one RF electrode mounted in the vicinity of the distal end of the shaft, an electrical connector disposed in the vicinity of the handle configured to connect the RF ablation element to a source of radiofrequency energy, whereby the geometric parameters of the probe shaft and RF ablation element are configured for RF ablation of the nasal nerve according to the methods disclosed here within, wherein the RF ablation element includes at least one needle configured for interstitial RF ablation.
Another example of the present disclosure is an electrosurgical probe apparatus for ablation of a nasal nerve comprising a handle at the proximal end, a probe shaft comprising a distal and proximal end, and an integrated circuit comprising an RF generator disposed in the vicinity of the handle and an RF ablation element disposed in the vicinity of the distal end of the shaft, whereby the geometric parameters of the probe shaft and RF ablation element are configured for RF ablation of the nasal nerve according to the methods disclosed here within.
Yet another example of the present disclosure is an ultrasonic energy emitting probe apparatus for ablation of a nasal nerve comprising a handle at the proximal end, a probe shaft with an ultrasonic energy ablation element comprising at least one ultrasonic energy emitter mounted in the vicinity of the distal end of the shaft, an electrical connector in the vicinity of the handle configured to connect the ultrasonic energy emitter to an ultrasonic energy generator, whereby the geometric parameters of the probe shaft and ultrasonic energy emitter are configured for ultrasonic energy ablation of the nasal nerve according to the methods disclosed here within.
In another example of this disclosure is an ultrasonic energy emitting probe apparatus for ablation of a nasal nerve comprising a handle at the proximal end, a probe shaft with an ultrasonic energy ablation element comprising at least one ultrasonic energy emitter mounted in the vicinity of the distal end of the shaft, an electrical connector in the vicinity of the handle configured to connect the ultrasonic energy emitter to an ultrasonic energy generator; at least one fluid path in communication between at least one fluid connector in the vicinity of the handle and the ultrasonic energy emitter configured to cool the ultrasonic energy emitter during ultrasonic energy emission, whereby the geometric parameters of the probe shaft and ultrasonic energy emitter are configured for ultrasonic energy ablation of the nasal nerve according to the methods disclosed here within.
Methods of use of any of the devices described above are now provided. The posterior nasal nerves (PNN) include nerves that originate from the SPG and innervate the nasal mucosa on the posterior side of the nasal cavity. Ablating these nerves, as well as other nerves in the nasal cavity, leads to a decrease in or interruption of parasympathetic nerve signals that contribute to congestion and rhinorrhea in patients with chronic rhinitis (allergic or non-allergic). The devices and methods described herein are configured to be used for ablating one or more of these nasal nerves to reduce or eliminate rhinitis.
Generally, the devices described above may be used to ablate a nasal nerve of a nasal tissue region of a nasal cavity of a patient. One method for treating the nasal tissue region within a nasal cavity in proximity to the at least one nerve may include introducing a distal end of a probe shaft through the nasal cavity, wherein the distal end has an end effector with a first configuration having a low-profile which is shaped to manipulate tissue within the nasal cavity. The distal end may be positioned into proximity of the tissue region having the nasal nerve. Once suitably positioned, the distal end may be reconfigured from the first configuration to a second configuration, which is shaped to contact and follow the tissue region. The distal end may then be used to ablate the nasal nerve within the tissue region utilizing a number of different tissue treatment mechanisms, e.g., cryotherapy, as described herein.
In treating the tissue region in one specific variation, the distal end may be positioned specifically into proximity of the tissue region which is surrounded by the middle nasal turbinate, inferior nasal turbinate, and the lateral wall of the nasal cavity, forming a cul-de-sac and having the PNN. The distal end may be reconfigured to treat the tissue region accordingly.
Various configurations for the distal end may be utilized in treating the tissue region so long as the distal end is configured for placement within the narrowed confines of the nasal cavity and more specifically within the confines of the tissue region surrounding the middle nasal turbinate, inferior nasal turbinate, lateral nasal tissue wall, and inferior meatus. Other anatomical locations within the nasal cavity are alternatively or additionally treatable with the configurations described herein.
As described above, one example of a surgical probe configured for ablating a tissue region such as the nasal cavity includes a surgical probe apparatus having a surgical probe shaft comprising an elongated structure with 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 deflated configuration and an expanded configuration. A lumen may be defined through the shaft in fluid communication with an interior of the expandable structure. A member may be attached to the distal end and extend within the expandable structure which encloses the member such that the member is unattached to the interior of the expandable structure. Moreover, the member may define an atraumatic shape, which is sized for pressing against and manipulating through the expandable structure the nasal tissue region.
An example of utilizing such a structure in treating the tissue region may generally include advancing the distal end of the surgical probe shaft through the nasal cavity and into proximity of the target nasal tissue region having and introducing a cryogenic fluid into the expandable structure attached to the distal end of the probe shaft such that the expandable structure inflates from a deflated configuration into an expanded configuration against the target nasal tissue region.
A position of the member relative to the target nasal tissue region may be adjusted where the member is attached to the distal end of the probe shaft and extends within the expandable structure, which encloses the member such that the member is unattached to an interior of the expandable structure. The practitioner may apply a pressure against the distal end such that the member is pressed against the interior of the expandable structure which in turn is pressed against the target nasal tissue region, wherein the member defines an atraumatic shape which is sized for pressing against and manipulating the target nasal tissue region. The member may be maintained against the interior of the expandable structure and the target nasal tissue region until the target nasal tissue region is cryogenically ablated.
Any of the ablation devices herein can be used to ablate a single nerve branch or multiple nerve branches.
Another aspect of this disclosure is a method for treating rhinitis by ablating a nasal nerve. The method may include inserting the distal end of a surgical probe configured for cryo-neurolysis into a nostril of a patient. The surgical hand piece disposed on the proximal end of the probe shaft may include a liquid cryogen reservoir, as discussed above. The distal expandable structure may be positioned against the lateral nasal wall proximate to a target nasal nerve and then a flow of liquid cryogen to the expandable structure may be activated for a period of time sufficient to cryo-ablate a target area in the nose containing target nasal nerves.
The method may further involve the targeting of at least one additional posterior nasal nerve, either within the ipsilateral nasal cavity, or a posterior nasal nerve in a contralateral nasal cavity.
The method may include controlling the flow of the liquid cryogen 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 elapsed time, cryogenic liquid evaporation pressure, cryogenic liquid evaporation temperature, cryogenic gas exhaust temperature, visual determination of tissue freezing, ultrasonic determination of tissue freezing, or the volume of cryogenic liquid supplied by the cryogenic liquid reservoir.
The method may include determining the location of the target nasal nerve, which may involve one or more of the following targeting techniques: endoscopic determination based on the nasal anatomical landmarks, electrical neuro-stimulation of the target nasal nerve while observing the physiological response to the stimulation, electrical neuro-blockade, while observing the physiological response to the blockade, or identification of the artery associated with the target nasal nerve using, e.g., ultrasonic or optical Doppler flow techniques.
Though the presently-disclosed devices and methods have primarily been discussed in the context of cryotherapy, the devices, systems, and methods described herein may have applicability with other ablative and non-ablative surgical techniques. For example, examples may include devices, systems, and methods that utilize heating/hyperthermia therapies. Examples utilizing heating/hyperthermia therapies may be similar in structure and steps as examples utilizing hypothermic therapies. Sources of heat for use with hyperthermia-based therapies may include RF energy, microwave energy, ultrasound energy, resistive heating, exothermic chemical reactions, combinations thereof and other heat sources known to those skilled in the art. Further, the disclosure may be applied as a standalone system or method, or as part of an integrated medical treatment system. It shall be understood that different aspects of the disclosure can be appreciated individually, collectively, or in combination with each other.
Further, though the presently-disclosed devices and methods have primarily been discussed in the context of ablating a least one nasal nerve associate with the lateral nasal wall of a nasal cavity of a patient, treatments may similarly be applied additionally or alternatively to the septal wall, roof of the nasal cavity, or other regions of the nasal cavity.
The methods described herein can be utilized effectively with any of the examples or variations of the devices and systems described above, as well as with other examples and variations not described explicitly in this document. The features of any of the devices or device components described in any of the examples herein can be used in any other suitable example of a device or device component.
It should be understood that arrangements described herein are for purposes of example only. As such, those skilled in the art will appreciate that other arrangements and other elements (e.g. machines, interfaces, functions, orders, and groupings of functions, etc.) can be used instead, and some elements may be omitted altogether according to the desired results. Further, many of the elements that are described are functional entities that may be implemented as discrete or distributed components or in conjunction with other components, in any suitable combination and location, or other structural elements described as independent structures may be combined.
While various aspects and examples have been disclosed herein, other aspects and examples will be apparent to those skilled in the art. The various aspects and examples disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope being indicated by the following claims, along with the full scope of equivalents to which such claims are entitled. It is also to be understood that the terminology used herein is for the purpose of describing particular examples only, and is not intended to be limiting.
The present application claims the benefit of U.S. Provisional Application No. 62/872,195 filed on Jul. 9, 2019, the contents of which is hereby incorporated by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2020/041248 | 7/8/2020 | WO |
Number | Date | Country | |
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62872195 | Jul 2019 | US |