Patent Description:
<FIG> is an internal view of the nasal cavity of the nose of <FIG> showing the nasal structures and a portion of the nasal neural anatomy. Shown for orientation is the lateral nasal cavity wall W, the nose N, nostril NO, and the upper lip UL. The superior turbinate T1, middle turbinate T2, and inferior turbinate T3 are depicted along with a portion of the nasal neural anatomy shown in dashed lines. The sphenopalatine ganglion SG (also known as the pterygopalatine ganglion, Meckel's ganglion, or nasal ganglion) is a parasympathetic ganglion located within the lateral wall W beneath a portion of the middle turbinate M2. Extending from the sphenopalatine ganglion SG are the posterior nasal nerves. The lateral branches, known as the lateral posterior nasal nerves N1, N2 and N3 innervate the lateral walls and turbinates T1, T2, T3. The medial branches, known as the medial posterior nasal nerves, innervate the septum and are not shown in this figure. These nerves, along with the vasculature and various other nasal structures, assist in controlling the response of the mucosa to various factors, thereby influencing the shrinking and swelling of the turbinates and the production of nasal secretion. Ideally these systems maintain a properly functioning nasal environment, however there are a variety of factors which can lead to debilitated states, including rhinitis.

Rhinitis is defined as inflammation of the mucous membranes or mucosa lining the nose, characterized by nasal symptoms including itching, rhinorrhea, congestion, sneezing, and post-nasal drip. Rhinitis can occur due to the common cold or seasonal allergies. However, in some instances persistent or chronic rhinitis occurs wherein the symptoms continue long-term. Typically, the symptoms are present for some part of the day on most days over a long period of time. Many people become distressed by their regular, daily symptoms. Severe symptoms can affect their work, school, home and social life.

Chronic rhinitis is categorized into three types (<NUM>) non-allergic (vasomotor) rhinitis which includes idiopathic, hormonal, atrophic, occupational, and gustatory rhinitis, as well as rhinitis medicamentosa (drug-induced); (<NUM>) allergic rhinitis, triggered by pollen, mold, animal dander, dust, and other inhaled allergens; and (<NUM>) mixed rhinitis which is a combination of non-allergic and allergic rhinitis.

Non-allergic rhinitis refers to rhinitis that is not due to an allergy. The exact cause of non-allergic rhinitis is unknown however it can occur when blood vessels in the nose expand or dilate, filling the nasal lining with blood and fluid. There are several possible causes of this abnormal expansion of the blood vessels or inflammation in the nose. One possibility is that the nerve endings in the nose may be hyperresponsive to stimuli or triggers. There are a number common triggers of non-allergic rhinitis, including: (a) environmental or occupational irritants, such as dust, smog, secondhand smoke or strong odors (e.g. perfumes); (b) chemical fumes, such as exposure in certain occupations; (c) weather changes, such as temperature or humidity changes; (d) foods and beverages, such as hot or spicy foods or drinking alcoholic beverages; (e) certain medications, such as aspirin, ibuprofen (Advil, Motrin IB, others), high blood pressure medications (e.g. beta blockers), sedatives, antidepressants, oral contraceptives, drugs used to treat erectile dysfunction, and overuse of decongestant nasal sprays, and (f) hormone changes, such as due to pregnancy, menstruation, oral contraceptive use or other hormonal conditions such as hypothyroidism. Often these triggers are difficult or impossible to avoid leading to a chronic health condition.

Allergic rhinitis may follow when an allergen such as pollen or dust is inhaled by an individual with a sensitized immune system, triggering antibody production. These antibodies mostly bind to mast cells, which contain histamine. When the mast cells are stimulated by an allergen, histamine (and other chemicals) are released. This causes itching, swelling, and mucus production. Characteristic physical findings in individuals who have allergic rhinitis include conjunctival swelling and erythema, eyelid swelling, lower eyelid venous stasis, lateral crease on the nose, swollen nasal turbinates, and middle ear effusion. Allergic rhinitis can occur as a local allergy in the nose that is not revealed by intradermal or blood tests for allergies. Therefore, many people who were previously diagnosed with nonallergic rhinitis may actually have local allergic rhinitis.

Chronic rhinitis can lead to a variety of complications. Sinusitis is the most common complication of chronic rhinitis. The sinuses are small, air-filled spaces inside the cheekbones and forehead. Sinuses make some mucus which drains into the nose through small channels. If the nose is blocked or congested, the sinuses may not drain properly into the nose. This means that the mucus in the sinuses becomes blocked and can be more easily infected. Another complication is nasal polyps. These are soft, noncancerous (benign) growths that develop on the lining of the nose or sinuses due to chronic inflammation. Large polyps may block the airflow through the nose, making it difficult to breathe. Middle ear infections are another complication of chronic rhinitis due to the increased fluid and nasal congestion. Due to all of these, a common complication is decreased quality of life. Chronic rhinitis can be disruptive and interrupt daily activities. Productivity at work or school may lessen and time may be lost to symptom flares or doctor visits.

Medical treatments have been shown to have limited effects for chronic rhinitis sufferers. Allergic rhinitis sufferers are typically directed to avoid the cause of the allergy, which may be difficult or impossible, or use daily medications such as antihistamine nose sprays, antihistamine tablets and steroid nose sprays. These medications can be onerous and may cause undesired side effects. Non-allergic rhinitis is more difficult to treat and such treatment depends on the cause, which may be unknown. Therefore, chronic rhinitis sufferers typically have few treatment options.

One type of treatment is turbinate reduction surgery. As mentioned previously, the turbinates help warm and moisturize air as it flows through the nose. However, the turbinates become enlarged in chronic rhinitis, blocking nasal airflow. There are many ways to reduce the size of the turbinates. Surgery is typically called turbinate reduction or turbinate resection. It is important that the turbinate not be excessively reduced or removed completely because it can lead to "empty nose syndrome" (ENS) which describes a nose that has been physiologically crippled by excessive surgical removal of turbinates in the nose. Side effects include chronic mucosal inflammation (which can cause areas of the mucosa to atrophy), paradoxical obstruction (the feeling that the nose is stuffy, often accompanied by a constant or frequently occurring troubling feeling of suffocation generated by poor airflow feedback from the nasal mucosa), and neuropathic pain in the nose, pharynx, eustachian tube, throat, larynx, trachea, in more severe cases - in bronchi and lungs. Chronic hoarse voice and cough can also take place. This is caused by insufficiently processed (moisturized, warmed, cleaned) air passing through the respiratory system. ENS can also serve as a prerequisite for asthma.

Even when turbinate reduction surgery is done conservatively, it can have a temporary duration of effect of <NUM>-<NUM> years and can result in complications including mucosal sloughing, acute pain and swelling, and bone damage. Additionally, turbinate reduction does not treat the symptom of rhinorrhea.

In addition, some rhinitis patients are unresponsive to treatment. Such patients have failed treatments including antihistamines, topical and systemic steroids, topical anticholinergics, turbinectomies and specific immunotherapy (SIT), including subcutaneous (SCIT) and sublinguale (SLIT). For such patients, neural surgery has been introduced as a last line of treatment. Golding-Wood first introduced the concept of vidian neurectomy as definitive surgical management for chronic rhinitis in the <NUM>. The theoretical basis of this surgery is an imbalance between parasympathetic and sympathetic innervation of the nasal cavity, and the resultant stimulation of goblet cells and mucous glands. The aim of this surgical technique is to disrupt this imbalance and reduce nasal secretions. The vidian nerve connects to the pterygopalatine ganglion inside pterygopalatine fossa and exits the skull through the pterygoid (vidian) canal. In a vidian neurectomy procedure, the vidian nerve was transected to decrease congestion and rhinitis. However, many practitioners have abandoned vidian neurectomy due to technical difficulty, its transient effectiveness and reports of complications, such as transient cheek and dental numbness, damage to the maxillary nerve (foramen rotundum), nasal crusting, dryness, initiation of bronchial asthma, bleeding, and ocular complications including vision loss and dry eyes due to severing of autonomic fibers in the vidian nerve that supply the lacrimal glands.

Recent studies have shown that selectively interrupting the Posterior Nasal Nerves (PNN) in patients with chronic rhinitis improves their symptoms while avoiding the morbidities associated with vidian neurectomy. Posterior nasal neurectomy, initially developed by Kikawada in <NUM> and later modified by Kawamura and Kubo, is an alternative method in which neural bundles are selectively cut or cauterized from the sphenopalatine foramen. Autonomic and sensory nerve fibers that pass through the foramen anatomically branch into the middle and inferior turbinate and are distributed around the mucosal layer of the nose. Therefore, selective neurectomy at this point enables physicians to theoretically avoid detrimental surgical complications such as inhibition of lacrimal secretion.

The study by Ikeda et. al suggests that the effect of an anticholinergic drug on nasal symptoms resembled that of PNN resection in patients with chronic rhinitis. Based on his study the glandular mucosal acinar cells were significantly reduced after the PNN resection. The reduction in glandular cells may be explained by decreased secretion of the nerve growth factor or epidermal growth factor regulated by acetylcholine, a major neurotransmitter of parasympathetic systems.

Chronic rhinitis is a global medical problem with few successful treatment options having minimal side effects and satisfactory results. Some estimate between <NUM>% and <NUM>% of the world population suffers from rhinitis symptoms. That is roughly the population of the United States and China combined. Treatment tends to be expensive to our health care system. It is estimated in <NUM> that allergic rhinitis alone accounted for <NUM> billion dollars in indirect and direct medical costs. The addition of non-allergic rhinitis grows this number substantially. Rhinitis is also a particular problem because patients can be misdiagnosed and mismanaged by primary care providers, costing much more to the system in lost days of work for ineffective treatment and continued discomfort to the patient. It is important to treat these patients properly in order to decrease the associated costs. At least some of these objectives will be met by the present invention. <CIT> discloses systems for facilitating intranasal treatment of a patient's sphenopalatine/pterygopalatine recess. Likewise the instant system is effective for addressing acute pain conditions, and is refined enough to be performed by physician's assistants, nurses, and other well-trained practitioners. An apparatus involved includes a sheath hub, a catheter hub, an arresting element, and an engagement element in embodiments. Engagement between the arresting element and the engagement element prevents rotation of the sheath hub with respect to the catheter hub. <CIT> discloses an apparatus and methods for treating conditions such as rhinitis, where a distal end of a probe shaft is introduced through the nasal cavity where 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 a tissue region having a post nasal nerve associated with a middle or inferior nasal turbinate. 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 and the post nasal nerve may then be ablated via the distal end. Ablation may be performed using various mechanisms, such as cryotherapy, and optionally under direct visualization. <CIT> discloses a direct vision cryosurgical and methods of use, whereing the device comprises an elongated rigid structure with a distal end, a proximal end, and a central lumen. The distal end comprises a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen. The distal end houses at least one imaging device configured for distal imaging. A proximal end of the device comprises a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end with a cryo-ablation probe through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes. <CIT> discloses devices and methods for treating rhinitis, whereing the devices are configured to ablate a single nerve branch or multiple nerve branches of the posterior nasal nerves located within the nasal cavity. A surgical probe may be inserted into the sub-mucosal space of a lateral nasal wall and advanced towards a posterior nasal nerve associated with a middle nasal turbinate or an inferior nasal turbinate into a position proximate to the posterior nasal nerve where neuroablation of the posterior nasal nerve may be performed with the surgical probe. The probe device may utilize a visible light beacon that provides trans-illumination of the sub-mucosal tissue or an expandable structure disposed in the vicinity of the distal end of the probe shaft to enable the surgeon to visualize the sub-mucosal position of the distal end of the surgical probe from inside the nasal cavity using, e.g., an endoscope. <CIT> discloses methods and an apparatus for the treatment of a body cavity or lumen, wherein a heated fluid and/or gas may be introduced through a catheter and into treatment area within the body contained between one or more inflatable/expandable members. The catheter may also have optional pressure and temperature sensing elements which may allow for control of the pressure and temperature within the treatment zone and also prevent the pressure from exceeding a pressure of the inflatable/expandable members to thereby contain the treatment area between these inflatable/expandable members. Optionally, a chilled, room temperature, or warmed fluid such as water may then be used to rapidly terminate the treatment session.

The present invention is defined in appended independent claim <NUM>. Further embodiments are defined appended dependent claims. The present invention generally relates to medical systems and devices usable for treating a tissue region within a nasal cavity of a patient. The invention allows for increased lateral contact or apposition of a target tissue region having at least one posterior nasal nerve with the end effector surface by lateral and/or longitudinal translation of the end effector relative to the surgical probe shaft. This improved lateral surface contact has several benefits, including improved patient outcomes and patient safety as the end effector is adequately in contact with target tissue for subsequent ablation therapy.

Embodiments include a method for treating a tissue region within a nasal cavity of a patient. The method is not part of the claimed invention and includes inserting a distal end of a surgical probe into a nostril of a nasal cavity of a patient in a first configuration. The surgical probe includes an outer shaft, an inner shaft positioned within a lumen of the outer shaft and translatable relative to the outer shaft, and an end effector coupled to a distal end of the inner shaft. The distal portion of the inner shaft in the first configuration may be substantially aligned with a longitudinal axis of the outer shaft and the end effector may be positioned a first distance from a distal end of the outer shaft in the first configuration. The method further includes advancing the distal end of the surgical probe from the nostril into a middle meatus of the nasal cavity with the surgical probe in the first configuration. The method further includes translating the inner shaft relative to the outer shaft so that the surgical probe is deployed to a second configuration. In the second configuration, the end effector is translated longitudinally to a second distance greater than the first distance away from the distal end of the outer shaft and laterally away from the longitudinal axis of the outer shaft. In the second configuration, the end effector may be positioned within proximity of a tissue region having at least one posterior nasal nerve. The method further includes ablating the at least one posterior nasal nerve of the tissue region with the end effector.

In embodiments, the method includes initially contacting the end effector with an anatomical feature of the middle meatus to a lateral wall of the nasal cavity prior to translating the inner shaft relative to the outer shaft. Translating the inner shaft relative to the outer shaft may include translating from a posterior portion of the tissue region to an anterior portion of the tissue region so that a surface of the end effector successively increases lateral contact with the tissue region. This ability to fully contact the tissue region with the end effector using translation of the probe is advantageous because it can be accomplished with stretching the nostril or applying pressure to the septum. In embodiments, the first distance of the end effector from the distal end of the outer shaft may be in a range less than <NUM> and the second distance of the end effector from the distal end of the outer shaft may be in a range from <NUM> to <NUM>. The lateral translation of the end effector away from the longitudinal axis of the outer shaft may be in a range from <NUM> degrees to <NUM> degrees.

In embodiments, the outer shaft may comprise an angled tip defining an angle between the distal portion of the inner shaft in the second configuration and the longitudinal axis of the outer shaft. The probe may have an angled tip, biased stylet, or both features to articulate the end effector laterally away from the longitudinal axis of the outer shaft. The inner shaft may include a flexible or self-expandable material.

The inner shaft may include a biased stylet. Translating the biased stylet relative to the outer shaft may deploy the surgical probe from the first configuration where the stylet is constrained by the outer shaft in a substantially straightened configuration to the second configuration where the stylet is unconstrained by the outer shaft in a curved configuration to articulate the end effector laterally away from the longitudinal axis of the of the outer shaft.

The method may further include maintaining the outer shaft substantially stationary relative to the nostril during the translation of the inner shaft relative to the outer shaft. By maintaining the outer shaft in this way, as opposed to retreating out of the nostril with the outer shaft during translation, the translation of the inner shaft causes the end effector in laterally contact the tissue region. With this method nostril stretching by the outer shaft may be inhibited during the translation of the inner shaft relative to the outer shaft. The method may further include maintaining the outer shaft at an orientation substantially parallel to a sagittal plane of the patient during the translation of the inner shaft relative to the outer shaft.

In embodiments, the end effector may include an expandable structure coupled to the distal end of the inner shaft and an inner member is disposed at the distal end of the inner shaft extending within the expandable structure which encloses the inner member such that the inner member is unattached to an interior of the expandable structure. The method may further include introducing a cryogenic fluid into the expandable structure such that the expandable structure inflates from a deflated configuration into an expanded configuration against the tissue region. the cryogenic fluid may evaporate within the expandable structure so as to cryogenically ablate the at least one posterior nasal nerve. The method may further include maintaining the inner member against the interior of the expandable structure and the tissue region until the at least one posterior nasal nerve is cryogenically ablated.

In embodiments, the inner member may include a first member and a second member. The inner member may be configurable from an expanded configuration wherein the first member and second member define a first width of the end effector between the first member and the second member, to a compressed configuration wherein the first member and the second member define a second width of the end effector that is smaller than the first width. The inner member may be in the compressed configuration when the distal end of the surgical probe is inserted into the nostril and in the expanded configuration when the end effector is positioned within the tissue region having the at least one posterior nasal nerve. The first width may be in a range from <NUM> to <NUM>. The first member and second member do not overlap in the expanded configuration. The second width may be in a range from <NUM> to <NUM>. The first
member and second member may overlap in the compressed configuration. The first and second members may have a heart shape in the expanded configuration and an oblong shape in the compressed configuration. The inner member may include a planar member having an elongate loop shape.

Embodiments further include a telescoping surgical probe, which may be used in the methods discussed above for treating a tissue region within a nasal cavity of a patient. The probe may include an elongate outer shaft having a distal end configured for insertion into a nostril of a nasal cavity of a patient. The outer shaft has a longitudinal axis and lumen therethrough. The probe may further include an elongate inner shaft positioned within the lumen of the outer shaft and translatable relative to the outer shaft and an end effector coupled to a distal end of the inner shaft. The distal portion of the inner shaft may be substantially aligned with the longitudinal axis of the outer shaft and the end effector may be positioned a first distance from the distal end of the outer shaft when the surgical probe is in a first configuration during insertion and advancement of the surgical probe into a middle meatus of the nasal cavity. Translation of the inner shaft relative to the outer shaft may configure the end effector longitudinally to a second distance greater than the first distance away from the distal end of the outer shaft and laterally away from the longitudinal axis of the outer shaft when the surgical probe is in a second configuration, wherein the end effector in the second configuration is in lateral contact with a tissue region having at least one posterior nasal nerve and is configured to ablate the at least one posterior nasal nerve. The end effector may include a cryotherapy balloon; and the probe may further include a cryogenic fluid source coupled to the inner shaft and a lumen disposed in the inner shaft and in fluid communication with the cryogenic fluid source and an interior of the balloon. Further, the end effector may be flexibly coupled to the inner shaft.

Further embodiments may include a probe for treating a target area within a nasal cavity. The probe may include an elongate probe shaft having a distal end configured for insertion into the nasal cavity, wherein the elongate shaft has a longitudinal axis and a lumen therethrough. The probe many further include a stylet comprising a shaft having a distal end and an end effector disposed along the distal end of the stylet shaft. The end effector may be configured to modify a property of the target area. The stylet shaft may have a curvature disposed proximal to the end effector. The distal end of the stylet may be retractable into the lumen of the probe shaft so that the lumen straightens the curvature of the stylet so as to position the end effector near the longitudinal axis and the distal end of the stylet is advanceable so that the curvature is positionable beyond the elongate probe shaft allowing the stylet to bend along the curvature so as to position the end effector laterally away from the longitudinal axis and toward the target area.

In embodiments, the target area may be located along a lateral wall of the nasal cavity and may include a posterior nasal nerve within a cul-de-sac. The curvature of the stylet may bend the stylet so that the end effector is positionable against the target area while the probe shaft extends out of a nostril without substantially tilting the probe shaft within the nostril. The curvature may bend the stylet so that the end effector is positionable against the lateral wall while the probe shaft extends out of a nostril, and wherein an application of force along the longitudinal axis of the probe shaft translates the force to lateral pressure applied by the end effector to the target area. The curvature may bend the stylet approximately <NUM>-<NUM> degrees from the longitudinal axis.

In embodiments, the temperature therapy is cryotherapy and the end effector may comprise a balloon. The end effector may be flexibly joined with the shaft of the stylet.

Further embodiments may include a probe for treating a target area located within a nasal cavity. The target area may be disposed lateral to an axis extending through a nostril. The probe may include a probe shaft having a distal end configured for insertion into the nasal cavity and a longitudinal axis alignable with the axis extending through the nostril. The probe may further include an end effector disposed along the distal end of the probe shaft, and the end effector may be configured to contact the target area while the longitudinal axis is aligned with the axis extending through the nostril. The probe may further include a lateral support disposed along the distal end of the probe shaft, wherein a portion of the lateral support is moveable laterally outwardly from the longitudinal axis so as to contact a support surface within the nasal cavity so as to hold the end effector against the target area. The target area may be located along a lateral wall of the nasal cavity and the support surface may be located along a turbinate or septum. The target area may include a posterior nasal nerve within a cul-de-sac. The end effector may be disposed along a first side of the distal end of the probe shaft and the lateral support may be disposed along a second side of the distal end of the probe shaft, wherein the lateral support is movable between a collapsed configuration wherein the support is disposed near the longitudinal axis during insertion into the nasal cavity and an expanded configuration wherein the portion of the lateral support moves laterally outwardly. The lateral support may include a flexible strip fixedly attached to the elongate probe shaft near the distal end of the probe shaft and slidably attached to the probe shaft at a proximal location so that sliding advancement of the flexible strip in relation to the probe shaft causes the lateral support to move from the collapsed configuration to the expanded configuration. The strip may bow laterally outwardly from the probe shaft between the fixed attachment and the slidable attachment when in the expanded configuration. A portion of the support may contact the support surface within the nasal cavity so as to hold the end effector against the target area with sufficient force to apply pressure to the target area. A portion of the lateral support may be extendable laterally outwardly so as to contact the support surface within the nasal cavity with sufficient force to tip a portion of the distal end of the probe shaft away from the longitudinal axis.

In embodiments, the lateral support may have a free end which extends laterally outwardly from the longitudinal axis so as to contact the support surface to provide lateral support to the end effector. The free end may extend laterally outwardly from the longitudinal axis by bending at a hinge, kink point or pre-formed bend. The lateral support may include a strip slidably attached to the probe shaft so that sliding advancement of the strip in relation to the probe shaft releases the free end and allows the free end to bend laterally outwardly. The end effector may include a sheath, and the lateral support may include an internal expander disposed within the sheath. The expander may have a longitudinal segment aligned with the longitudinal axis and at least one expanding segment, and the expander may be movable between a collapsed configuration wherein the at least one expanding segment is disposed near the longitudinal segment and an expanded configuration wherein the at least one expanding segment moves laterally outwardly from the longitudinal axis. The sheath may include a non-inflatable balloon configured to delivery cryotherapy. The at least one expanding segment may include at least two expanding segments, and one of the at least two expanding segments may expand laterally outwardly toward the target area while another of the at least two expanding segments expands laterally outwardly toward the surface within the nasal cavity. At least one of the at least one expanding segments may move laterally outwardly from the longitudinal axis by flexible bowing. At least one of the at least one expanding segments may move laterally outwardly from the longitudinal axis by bending at a hinge, kink point or flex point. At least one expanding segments may be fixedly attached to the longitudinal segment at a first location and slidably attached at a second location, and retraction of the longitudinal segment may draw the first location toward the second location which causes the at least one expanding segment to expand laterally outwardly.

Further embodiments may include a probe for treating a target area within a nasal cavity. The probe may include an elongate probe shaft having a longitudinal axis and a distal end configured for insertion into the nasal cavity. The probe may further include an end effector disposed along a first side of the distal end of the probe shaft, and the end effector may be configured for temperature therapy of the target area. The probe may further include a lateral support disposed along a second side of the distal end of the probe shaft. The lateral support may be movable between a collapsed configuration wherein the support is disposed near the longitudinal axis during insertion into the nasal cavity and an expanded configuration wherein a portion of the support extends laterally outwardly from the longitudinal axis so as to contact a surface near the target area to provide lateral support to the end effector.

The target area may be located along a lateral wall of the nasal cavity and the surface is located along a turbinate or septum. The target area may include a posterior nasal nerve within a cul-de-sac. The first side and the second side of the distal end of the probe shaft may be on opposite sides of the distal end of the support probe. The temperature therapy may include cryotherapy.

The lateral support may include a flexible strip fixedly attached to the elongate probe shaft near the distal end of the probe shaft and slidably attached to the probe shaft at a proximal location so that sliding advancement of the flexible strip in relation to the probe shaft causes the lateral support to move from the collapsed configuration to the expanded configuration. The strip may bow laterally outwardly from the probe shaft between the fixed attachment and the slidable attachment when in the expanded configuration. A portion of the support may be extendable laterally outwardly so as to contact the surface near the target area with sufficient force to translate pressure to the end effector against the target area. A portion of the support may be extendable laterally outwardly so as to contact the surface near the target area with sufficient force to tip a portion of the distal end of the probe shaft away from the longitudinal axis. The lateral support may have a free end which extends laterally outwardly from the longitudinal axis so as to contact the surface near the target area to provide lateral support to the end effector. The lateral support may have a free end which extends laterally outwardly from the longitudinal axis by bending at a hinge, kink point or pre-formed bend. The lateral support may include a strip slidably attached to the probe shaft so that sliding advancement of the strip in relation to the probe shaft releases the free end and allows the free end to bend laterally outwardly.

Further embodiments may include a probe for treating a target area within a nasal cavity. The probe may include an elongate probe shaft having a longitudinal axis and a distal end configured for insertion into the nasal cavity. The probe may further include a sheath disposed along the distal end of the probe shaft. The sheath may be configured to deliver temperature therapy to the area. The probe may further include an internal expander disposed within the sheath, wherein the expander has a longitudinal segment aligned with the longitudinal axis and at least one expanding segment, wherein the expander is movable between a collapsed configuration wherein the at least one expanding segment is disposed near the longitudinal segment during insertion into the nasal cavity and an expanded configuration wherein the at least one expanding segment moves laterally outwardly from the longitudinal axis so as to contact a surface near the target area to provide lateral support to the sheath. The sheath may comprise a non-inflatable balloon configured to delivery cryotherapy. The at least one expanding segment may comprise at least a two expanding segments, wherein one of the at least two expanding segments expands laterally outwardly toward the target area while another of the at least two expanding segments expands laterally outwardly toward a surface within the nasal cavity opposing the target area.

The target area may comprise a portion of a lateral wall containing a proximal nasal nerve and the surface within the nasal cavity opposing the target area comprises a turbinate or a septum. At least one of the at least one expanding segments may move laterally outwardly from the longitudinal axis by flexible bowing. At least one of the at least one expanding segments may move laterally outwardly from the longitudinal axis by bending at a hinge, kink point or flex point. At least one expanding segment may be fixedly attached to the longitudinal segment at a first location and slidably attached at a second location, and the retraction of the longitudinal segment may draw the first location toward the second location which causes the at least one expanding segment to expand laterally outwardly.

Further embodiments may include a probe for treating a target area within a nasal cavity. The probe may include an elongate probe shaft having a longitudinal axis and a distal end configured for insertion into the nasal cavity. The probe may further include an end effector disposed along the distal end of the probe shaft. The end effector may be configured to deliver therapy to the target area. The probe may further include an elongate rod having a proximal end alignable with the longitudinal axis of the elongate probe and a curved distal end extending laterally outwardly from the longitudinal axis. The distal end may have a tip positionable against a support surface within the nasal cavity, wherein positioning the tip against the support surface presses the end effector against the target area during delivery of therapy. The curved distal end may have a curvature of approximately <NUM> degrees so that the distal end of the rod is substantially perpendicular to the longitudinal axis. The rod may be malleable so as to adjust a curvature of the curved distal end. The end effector may have a broad surface configured to contact the target area, and the distal end of the rod may be rotatable between a position in parallel with the broad surface and perpendicular with the broad surface.

The target area may be located along a lateral wall of the nasal cavity and the support surface may be located along a turbinate or septum. The target area may include a posterior nasal nerve within a cul-de-sac.

The rod may be advanceable and retractable in relation to the probe shaft. The rod may be advanceable so that the curved distal end is positionable distal to the end effector and extends around the end effector so that the support surface that its distal tip is positionable against is adjacent the target area. The end effector may comprise an inflatable balloon and the rod may stabilize the balloon during delivery of the temperature therapy. The temperature therapy may include cryotherapy.

These and other embodiments are described in further detail in the following description related to the appended drawing figures.

The present invention generally relates to medical devices and systems, and more particularly relates to devices and systems usable for treating rhinitis. Such treatment of rhinitis is achieved by decreasing or interrupting nerve signals that are transmitted from the sphenopalatine ganglion to the nasal mucosa via the posterior nasal nerves. Decrease or interruption of nerve signals can be attained by a variety of methods, particularly by the application of physical therapies (compression or cutting), thermal therapies (heat or cold), or chemical therapies (alcohol or anesthetic injections). Examples of thermal therapies include cryotherapy, cryoneuromodulation, cryomodulation, cryolysis, cryoablation, and thermoablation. It has been found that a specific target area within the nasal cavity is particularly effective in treating rhinitis. This target area is located along the lateral wall W in the middle meatus within a cul-de-sac CDS. The cul-de-sac CDS in the middle meatus is defined superiorly by the Ethmoid bulla, posteriorly defined by the most posterior attachment point of the middle turbinate T2 to the lateral wall, inferiorly defined by the inferior turbinate T3 attachment to the lateral wall, anteriorly defined by the posterior tail of the uncinate process, and medially defined by the lateral side of the middle turbinate. The target area within the cul-de-sac may be approximately <NUM><NUM> in area, and in embodiments may range from <NUM><NUM> to <NUM><NUM>. The target area may include a concaved surface portion and a portion protruding out from the wall on the inferior side where the inferior turbinate attaches. <FIG> illustrates a portion of the nasal cavity including the target area <NUM>. In this illustration, a portion of the left side of the patient's face is omitted to allow for viewing inside of the nasal cavity, in particular the septum and the left side of the nose N has been omitted. Thus, the superior, middle and inferior turbinates T1, T2, T3 of the right side of the face are visible along the lateral wall W. The arrow <NUM> indicates a straight pathway through the nostril NO toward the location of the target area <NUM>.

<FIG> illustrates an embodiment of a probe <NUM> having a shaft <NUM> and a therapeutic end effector <NUM> inserted into the right nostril N and advanced into the middle meatus, an area underneath the middle turbinate and above the inferior turbinate, in a direction substantially corresponding to arrow <NUM> of <FIG>. The portion of the nasal cavity shown in <FIG> is a cross-section from above. As shown, a portion of the lateral wall W at the target area <NUM> is concave. The lateral posterior nasal nerves N2 passes through lateral wall at the Sphenopalatine foramen located within or slightly above the middle turbinate attachment to the lateral wall W. Portions of the posterior nasal nerves N2 spread in the nasal cavity and innervate the mucosa along the lateral wall W of the cul-de-sac CDS, defining the target area <NUM>. By applying one or more of the therapies noted above across the target area <NUM> with the end effector <NUM> of the probe <NUM>, the parasympathetic nerve signals passing there through are decreased or interrupted which alleviates rhinitis symptoms. The position and contours of the target area <NUM> in the cul-de-sac CDS can impede contact of the therapeutic end effector <NUM> across the entire target area <NUM>. Without contact across the entire target area the treatment may be less effective or ineffective. Therefore, it is desired to have complete contact with the target area within cul-de-sac CDS with the end effector <NUM> and apply pressure to the target area <NUM>. Such application of pressure compresses and thins the tissue layer (nasal mucosa) between the nerve area N2 and the end effector <NUM>, bringing the end effector <NUM> closer to the nerves and in cryoablation applications allows the temperature of the nerve to reach below - <NUM> degrees Celsius. Such pressure may also reduce blood flow through the target area <NUM>. Both of these aspects may increase the penetration and area of the therapy, increasing the effectiveness of the thermal therapy.

In embodiments, to make contact and apply pressure to the target area <NUM>, the probe <NUM> may be angled laterally relative to the sagittal plane so that the end effector reaches over the inferior turbinate T3 and underneath the middle turbinate T2, as illustrated in <FIG>, so that the end effector <NUM> enters the cul-de-sac CDS and makes contact with the lateral wall W. As shown, an angle, relative to the sagittal plane SP, used to reach the target <NUM> with the end effector <NUM> may cause the shaft <NUM> of the probe <NUM> to press against the septum S and also stretch the nostril NO. This pressure against the septum and stretching of the nostril can be uncomfortable for and harmful to the patient. Further, the obstruction caused by the septum S, inferior turbinate T3 and nostril NO can limit the contact area of the end effector <NUM> and the amount of pressure that can be applied to the target area <NUM> and thereby limit the effectiveness of the therapy. In embodiments, the shaft <NUM> may include a bent portion so that the end effector <NUM> is offset from the longitudinal axis of the shaft <NUM>. The bent portion may allow for more complete coverage of the target area <NUM> with the end effector <NUM>. In embodiments, the bend makes the width of the probe <NUM> larger than a straight probe, and therefore in order to advance the bent probe through the nasal cavity into the middle meatus without causing patient discomfort from pressing into the turbinates and/or septum the shaft may be made of a flexible material. The flexible material may have elasticity and be able to be straighten when advanced into the nasal cavity without causing excessive pressure against the nostril and the septum. When the end effector reaches the middle meatus, the shaft will bias due to the elasticity of the material to return to the bent configuration. Returning to the bend configuration causes the end effector to translate laterally toward the target area and contact and apply pressure to the target area.

<FIG> show an embodiment of a probe <NUM> comprising an outer shaft <NUM> and an inner shaft <NUM>, also referred to as a stylet. The inner shaft <NUM> is located within a lumen <NUM> of the outer shaft <NUM>. The inner shaft <NUM> includes a distal end portion <NUM>. Attached to the distal end portion is an end effector <NUM>. The inner shaft <NUM> is able to translate within and relative to the outer shaft <NUM>. Translation may be actuated with a trigger, or similar mechanism, located on a handle that the probe <NUM> is affixed to. The inner shaft <NUM> may translate from a first configuration, shown in <FIG>, wherein the end effector <NUM> is proximate to a distal end of the outer shaft <NUM>, to a second configuration, as shown in <FIG>, wherein the end effector <NUM> is translated away from the distal end of the outer shaft <NUM>. In the first configuration, the end effector <NUM> is positioned so that it substantially aligns with the longitudinal axis <NUM> of the outer shaft <NUM>. For example, the end effector may not extend beyond <NUM> from the longitudinal axis in the first configuration. This allows for easy insertion into the nostril NO and advancement into a meatus, such as the middle meatus. As shown in <FIG>, in the second configuration, the end effector <NUM> is translated at an angle relative to the longitudinal axis <NUM> of the outer shaft <NUM> so that the end effector <NUM> moves away from the distal end of the outer shaft <NUM> both longitudinally and laterally.

The outer shaft <NUM> is sized and configured to be advanceable through a nostril NO of a patient and within the nasal cavity by a user outside of patient. In embodiments, the outer shaft <NUM> is <NUM> long or longer, <NUM> or less in diameter, and made of malleable or rigid material such as stainless steel or heat treated stainless steel. In embodiments, the outer shaft <NUM> is semi-malleable to rigid and has a substantially straight configuration extending along the straight longitudinal axis <NUM>. The straightness of the outer shaft <NUM> allows the outer shaft <NUM> to reside comfortably within a nostril NO.

The end effector <NUM> is affixed to the distal end of the shaft <NUM>. In embodiments, end effector <NUM> comprises a flexible inner member and a thin film outer member. The inner member can be made from stainless steel, nitinol, or a higher durometer plastic. The thin film outer member can be made from < <NUM>" thick polymer film. Film material can be nylon, LDPE, Urethane, PET or co-extrusions of these types. In cryoablation applications, the end effector may be designed to reach freezing temperatures on all surfaces of the thin film outer member. The lateral wall facing surface of the end effector has an area ranging <NUM>-<NUM><NUM>, with a preferred circular area of <NUM><NUM>. The end effector may be inflatable and the width between lateral wall facing surface and middle turbinate facing surface of the end effector <NUM> in a deflated state when advancing to the target area may be <NUM>-<NUM>. Once over the target area <NUM>, the end effector may be transitioned to an inflated state with a width of <NUM>-<NUM>. In embodiments, the lateral wall facing surface is a circular shape with a diameter of <NUM>. In embodiments, the end effector <NUM> is attached to the distal end portion <NUM> either in line with the longitudinal axis <NUM> of the distal end portion <NUM> or at an angle relative to the longitudinal axis <NUM> of the distal end portion <NUM>.

In embodiments, the inner shaft <NUM>, including the distal end portion <NUM>, is comprised of a flexible material, such as a Nitinol, spring steel, Elgiloy or a flexible polymer. The inner shaft <NUM> may include a bend causing the distal end portion to be biased to a configuration where the distal end portion is at an angle relative to the rest of the inner shaft. The flexible material is configured to allow the distal end portion <NUM> and bend to straighten relative to the rest of the inner shaft <NUM>, when the probe <NUM> is in the first configuration and the distal end portion <NUM> is positioned within the lumen <NUM> of outer shaft <NUM>, as shown in <FIG>. In embodiments, the inner shaft <NUM> may be made of multiple components and/or materials. The distal end portion <NUM> may be made of a flexible material and the rest of the inner shaft <NUM> may be made of a semi-rigid to rigid material affixed to the distal end portion <NUM>.

In embodiments, the distal end of the outer shaft includes an angled tip <NUM>. The inner shaft <NUM> is advanced through the lumen <NUM> and the distal end portion <NUM> extends out of the outer shaft <NUM> through angled tip <NUM>. Angled tip <NUM> includes a lumen directing inner shaft <NUM> out from the angled tip <NUM> at a desired angle relative to the longitudinal axis <NUM> of the outer shaft <NUM>, as illustrated in <FIG>. In embodiments, the angle θ ranges from <NUM> to <NUM> degrees, more particularly from <NUM> to <NUM> degrees. The difference in distance the end effector <NUM> translates between the first configuration, at a distance of d1 from the distal end of the outer shaft, and the second configuration, at a distance of d2 from the distal end of the outer shaft, may ranges from <NUM> to <NUM>, and more particularly from <NUM> to <NUM>. During treatment, the range of translation may be based on the patient anatomy, and the inner shaft may be able to translate to any position with the range.

Probe <NUM> may be used in a therapeutic method wherein the target area may be treated without stretching the nostril or pressing against the septum. <FIG> illustrate the devices of <FIG> in use within the nasal cavity. During treatment, the probe <NUM> is placed in the first configuration with the end effector <NUM> proximate to the distal end of the outer shaft <NUM> and the distal end, i.e. end effector end, is inserted into the nostril of a patient. During this step, the end effector <NUM> may be in a deflated configuration. <FIG> illustrates the probe <NUM> after it has advanced partially into the nasal cavity. While the probe <NUM> is advanced it remains in the first confirmation as the end effector <NUM> travels from the nostril into the middle meatus. During this insertion, the longitudinal axis of the outer shaft <NUM> remains in a plane substantially parallel to the sagittal plane SP and is not angled to cause pressure against the septum and stretch the nostril. The probe <NUM> is continued to be advanced and is further inserted between and past the septum and the inner turbinate T3. The end effector <NUM> is advanced into the middle meatus by tucking the superior edge of the end effector <NUM> lateral to the middle turbinate and advancing probe <NUM> posteriorly and slightly superior along the inferior turbinate while keeping the end effector <NUM> underneath the middle turbinate T2. The probe <NUM> is advanced until the distal end of the end effector <NUM> touches the attachment of the middle turbinate T2 to the lateral wall within the cul-de-sac CDS. As shown in <FIG>, with the distal end of the outer shaft <NUM> tucked underneath the middle turbinate and the distal tip of the end effector touching attachment of the middle turbinate to the lateral wall, the inner shaft <NUM> is then advanced within the outer shaft <NUM> so that distal end portion <NUM> translates the end effector <NUM> laterally and posteriorly away from outer shaft <NUM> at a defined angle θ defined by angled tip <NUM> towards the target area <NUM>. The inner shaft <NUM> may be advance until a distal end of the end effector <NUM> slides along the attachment and up against the target area <NUM> along the lateral wall W. With the distal end of the end effector <NUM> contacting the posterior aspect of the target area <NUM> the probe <NUM> may be further translated posteriorly or the end effector <NUM> may be further translated from the outer shaft <NUM> so that portions of the end effector <NUM> and/or the distal end portion <NUM> flex or rotate and cause the end effector <NUM> to increase the surface area of the end effector <NUM> contacting the target area <NUM> in a an anterior direction. Therefore, using probe <NUM> allows the end effector <NUM> to be positioned against the target area without substantially angling the probe shaft <NUM> and causing pressure against the septum or stretching of the nostril. Therefore this translation of force is more effective and more comfortable for the patient than angling a probe shaft, as shown in <FIG>. It may be appreciated, however, that in some instances the probe shaft <NUM> may additionally be angled to accommodate particular anatomical features. In such instances, such tilting will be substantially less than without the ability to laterally extend the end effector <NUM>.

Once the end effector <NUM> is desirably placed against the target area <NUM>, the therapy may be applied. Such therapy may include heat, such as thermoablation, or cold, such as cryotherapy (cryoablation). The cryogen liquid is delivered through a small delivery tube as described in commonly owned <CIT>, entitled "APPARATUS AND METHODS FOR TREATING RHINITIS.

<FIG> an embodiment of a probe <NUM> that provides lateral support to the therapeutic end effector <NUM>. In embodiments probe <NUM> allows the end effector <NUM> to be moved laterally while a portion of the probe shaft <NUM> maintains its position. Probe <NUM> comprises an elongate shaft <NUM> sized and configured to be advanceable through a nostril NO of a patient and along a nasal meatus, such as a middle meatus between an inferior and middle turbinate. The shaft <NUM> has a distal end <NUM> and a proximal end <NUM>, wherein the end effector <NUM> is disposed at or along its distal end <NUM>. In this embodiment, the end effector <NUM> comprises an inflatable sheath or balloon <NUM> mounted on the elongate shaft <NUM>. In embodiments, the balloon <NUM> is configured for cryotherapy wherein the balloon <NUM> is fillable with a liquid cryogen that evaporates thus creating very low temperatures through the Joules-Thomson effect so as to deliver cold to a target area for cryoablation or cryomodulation thereto. In this embodiment, the probe <NUM> further includes a lateral support <NUM> which is disposed along the shaft <NUM> in a manner so as to provide support to the end effector <NUM> in a lateral direction when in use. In this embodiment, the lateral support <NUM> comprises an elongate rod, strip or ribbon extending along a side of the probe shaft <NUM>, attached to the distal end <NUM> and then extending unattached toward the proximal end <NUM>. A portion of the unattached support <NUM> extends through a lumen in the shaft <NUM> so as to be held flush with the shaft <NUM>, parallel to a longitudinal axis <NUM> of the shaft <NUM>. A remaining portion of the unattached support <NUM> remains free to move laterally away from the shaft <NUM>, perpendicular to the longitudinal axis <NUM>, so as to provide support in the lateral direction.

<FIG> illustrates the probe <NUM> in a collapsed configuration, wherein the balloon <NUM> is uninflated and the lateral support <NUM> is flush with the shaft <NUM> from the distal end <NUM> to the proximal end <NUM>. The shaft <NUM> is easily insertable into a nostril NO in the collapsed configuration. <FIG> illustrates the shaft <NUM> oriented so that the balloon <NUM> faces the target area (not shown) and the lateral support <NUM>, which is on the opposite side of the probe <NUM>, faces a tissue surface T opposite the target area so that the lateral support <NUM> can be used for supporting the balloon <NUM>. In the nose, the target area may, for example, reside along the lateral wall of the cul-de-sac and the opposite tissue surface would be the septum or other nearby tissue surfaces. <FIG> illustrates the probe <NUM> in an expanded configuration, wherein the balloon <NUM> is inflated for treatment and the lateral support <NUM> is extended so that a portion of the unattached portion bends, bows or flexes laterally outwardly from the longitudinal axis of the shaft <NUM> in the area of the end effector <NUM>, as shown. Such expansion of the lateral support <NUM> is achieved by advancement of the lateral support <NUM> through the lumen in the shaft <NUM>, toward the distal end <NUM>. The lateral support <NUM> remains flush with the shaft <NUM> within the lumen during advancement but bows laterally outwardly from the shaft <NUM> upon exiting the lumen wherein the support <NUM> is free to move. In embodiments, the lateral support <NUM> is comprised of a flexible material such as Nitinol, Nylon, Spring steel, polyethylene, Teflon or polyurethane. The lateral support <NUM> is advanced so that it bows to a point where the distance between the further bowing of the lateral support and surface of the balloon causes the lateral support to contact the nearby tissue T and balloon to contact the target area, as shown. In some instances, the balloon <NUM> is sufficiently inflated to contact a target area while the shaft <NUM> remains aligned with the longitudinal axis <NUM>. In such instances, the lateral support <NUM> may be bowed against the tissue T, opposite the target area, so as to hold the balloon <NUM> in position and apply lateral force to the balloon <NUM> and the target area. This applies pressure to the target area which may thin the tissue of the target area, bringing the balloon closer to the underlying target nerves. Such pressure may also reduce blood flow through the area. Both of these aspects may increase the penetration of the therapy, such as creating a deeper freeze zone.

In some instances, the inflated balloon <NUM> is not able to contact the target area while the shaft <NUM> remains aligned with the longitudinal axis <NUM>. In such instances, the lateral support <NUM> may be further advanced through the lumen to allow for additional bowing against the tissue T, as illustrated in <FIG>. As more of the lateral support <NUM> is extended, increasing force is applied to the distal point of attachment of the lateral support <NUM> to the shaft <NUM> (here the lateral support <NUM> is attached at a distal tip <NUM> of the shaft <NUM>). Such increasing force tips the distal end <NUM> of the shaft <NUM> away from the longitudinal axis <NUM>, such as by an angle θ. In embodiments, the angle θ ranges from <NUM> degrees to <NUM> degrees, more particularly from <NUM> degrees to <NUM> degrees. This allows the balloon <NUM> to reach a more laterally positioned target area, such as within the cul-de-sac, while maintaining alignment of the proximal end <NUM> of the shaft <NUM> with the longitudinal axis <NUM>.

<FIG> illustrates the probe <NUM> of <FIG> inserted into a nostril NO of a nose N. The probe <NUM> may be advanced therein in the collapsed configuration of <FIG>. Once positioned so that the balloon <NUM> is desirably aligned with the target area <NUM> along the wall W of the cul-de-sac CDS, the balloon <NUM> is inflated and the lateral support <NUM> is advanced to allow lateral extension of the free moving portion of the lateral support <NUM>. The lateral support <NUM> may laterally extend until it contacts the underside of the middle turbinate T2 and/or the septum S and provides pushback and lateral support to the inflated balloon <NUM>. In some instances, the support <NUM> is further extended to push the balloon <NUM> against the target area <NUM>. This assists in applying pressure to the target area <NUM>, potentially reducing the distance between the balloon <NUM> and the underlying target nerve N2. The support <NUM> also assists in maintaining such contact and pressure against the target area <NUM> during the therapeutic procedure, such as cryotherapy. This support may improve the treatment outcome by providing consistent and thorough contact, reducing the distance between the applied therapy and the target nerve N2, reducing blood flow and reducing patient discomfort related to probe movement and tilting.

In embodiments, the lateral support <NUM> may be attached to the shaft <NUM> at any suitable location, such as at any distance from the distal tip <NUM>. Variation in the location of the attachment point may create lateral support at different locations along the shaft <NUM>. Such variation may provide different locations of pressure application by the balloon <NUM>. Such variation may also provide different angles of tipping of the distal end of the shaft <NUM>. In embodiments, the support <NUM> may be held to the shaft <NUM> by features other than passing through a lumen in the shaft <NUM>. For example, the support <NUM> may be mounted on the exterior of the probe shaft <NUM>, passing beneath various straps or through various eyelets which hold the support <NUM> near or against the shaft <NUM>. Likewise, the support <NUM> may be slidably attached to the shaft <NUM> at one or more points in addition to the attachment point. Such slidable attachment points may be achieved by passing the support <NUM> through a short lumen in the shaft <NUM> or beneath a strap or through an eyelet exterior to the shaft <NUM>. Thus, as the support <NUM> is advanced, the support <NUM> is able to bow or bend laterally outwardly around the attachment points, creating more than one lateral support.

<FIG> illustrates another embodiment of a probe <NUM> that provides lateral support to the therapeutic end effector <NUM>, and in some instances allows the end effector <NUM> to be moved laterally while a portion of the probe shaft <NUM> maintains its position. In this embodiment, the probe <NUM> comprises an elongate probe shaft <NUM> sized and configured to be advanceable through a nostril NO of a patient and along a nasal meatus, such as a middle meatus between an inferior and middle turbinate. The shaft <NUM> has a distal end <NUM> and a proximal end <NUM>, wherein the end effector <NUM> is disposed at or along its distal end <NUM>. In this embodiment, the end effector <NUM> comprises an inflatable sheath or balloon <NUM> mounted on the elongate shaft <NUM>. In embodiments, the balloon <NUM> is configured for cryotherapy wherein the balloon <NUM> is fillable with a cryogenic liquid so as to deliver cold to a target area for cryoablation or cryomodulation thereto. In this embodiment, the probe <NUM> further includes a lateral support <NUM> which is disposed along the shaft <NUM> in a manner so as to provide support to the end effector <NUM> in a lateral direction when in use. In this embodiment, the lateral support <NUM> comprises an elongate rod, strip or ribbon extending within a lumen along a side of the probe shaft <NUM>, parallel to a longitudinal axis <NUM>. The lateral support <NUM> is not attached to the shaft <NUM> or the balloon <NUM>. The support <NUM> is advanceable through the lumen and has a hinge, kink point or pre-formed bend <NUM> near the distal end of the lateral support configured so that when the bend <NUM> is advanced out of the lumen, a distal tip <NUM> of the support <NUM> is moves laterally outward, away from the shaft <NUM> and balloon <NUM>. In embodiments, the lateral support <NUM> is comprised of nitinol or a shape-memory material, and the lateral support <NUM> may revert to its pre-formed shape, moving the distal tip <NUM> outward, perpendicular to the longitudinal axis <NUM>, so as to provide support in the lateral direction. In embodiments, the distal end of the support <NUM> forms an angle θ with the longitudinal axis. In some embodiments, the angle θ ranges from <NUM> degrees to <NUM> degrees, more particularly from <NUM> degrees to <NUM> degrees.

In embodiments, the inflated balloon <NUM> is not able to contact the target area while the shaft <NUM> remains aligned with the longitudinal axis <NUM>. In embodiments, a lateral support <NUM> may be used having a bend <NUM> located at a further distance from the distal tip <NUM>. This causes more of the support <NUM> to be extended laterally outwardly. Likewise, the support <NUM> may be positioned so that the bend <NUM> is disposed near the distal tip <NUM> of the shaft <NUM>. Thus, as more of the support <NUM> is extended the force applied to the distal tip <NUM> of the shaft <NUM> is increased. Such increasing force tips the distal end <NUM> of the shaft <NUM> away from the longitudinal axis <NUM>. This allows the balloon <NUM> to reach a more laterally positioned target area, such as within the cul-de-sac, while maintaining alignment of the proximal end <NUM> of the shaft <NUM> with the longitudinal axis <NUM>.

Referring again to <FIG>, in embodiments, the probe <NUM> is advanceable into the nostril NO of the nose N in a collapsed configuration, wherein the support <NUM> is against the shaft <NUM> and the balloon <NUM> is not inflated. Once positioned so that the balloon <NUM> is desirably aligned with the target area <NUM> along the wall W of the cul-de-sac CDS, the balloon <NUM> is inflated and the support <NUM> is advanced at least until the bend <NUM> is allowed to laterally extend the free end of the support <NUM>. The free end of the support <NUM> laterally extends until its distal tip <NUM> contacts the underside of the middle turbinate T2 and/or the septum S and is able to provide pushback and lateral support to the inflated balloon <NUM>. In some instances, the support <NUM> is further extended to push the balloon <NUM> against the target area <NUM>. This assists in applying pressure to the target area <NUM>, potentially reducing the distance between the balloon <NUM> and the underlying target nerve N2. The support <NUM> also assists in maintaining such contact and pressure against the target area <NUM> during the therapeutic procedure, such as cryotherapy. This support may improve the treatment outcome by providing consistent and thorough contact, reducing the distance between the applied therapy and the target nerve N2, reducing blood flow and reducing patient discomfort related to probe movement and tilting.

In embodiments, the bend <NUM> may be disposed at any suitable location, such as at any distance from the distal tip <NUM>. Likewise, the support <NUM> may be advanced or retracted to position the bend <NUM> at any location along the probe shaft <NUM>. Variation in the location of the attachment point may create lateral support at different locations along the shaft <NUM>. Such variation may provide different locations of pressure application by the balloon <NUM>. Such variation may also provide different angles of tipping of the distal end of the shaft <NUM>. In embodiments, the support <NUM> may be held to the shaft <NUM> by features other than passing through a lumen in the shaft <NUM>. For example, the support <NUM> may be mounted on the exterior of the probe shaft <NUM>, passing beneath various straps or through various eyelets which hold the support <NUM> near or against the shaft <NUM>.

<FIG> illustrate embodiments of probes <NUM> having end effectors <NUM> that extend in a lateral direction to reach target areas along the cul-de-sac while a portion of the probe shaft <NUM> maintains its position. In embodiments, the probe <NUM> comprises an elongate probe shaft <NUM> sized and configured to be advanceable through a nostril NO of a patient and along a nasal meatus, such as a middle meatus between an inferior and middle turbinate. The shaft <NUM> has a distal end <NUM> and a proximal end (not shown), wherein the end effector <NUM> is disposed at or along its distal end <NUM>. The end effector <NUM> comprises an inflatable or non-inflatable sheath or balloon <NUM> having an internal expander <NUM>. The balloon <NUM> may be configured for cryotherapy wherein the balloon <NUM> is fillable with a cryogenic liquid so as to deliver cold to a target area for cryoablation or cryomodulation thereto. The internal expander <NUM> acts as a scaffolding and is comprised of a suitable material for providing such structure, such as metal or polymer wire, filament, nitinol, or the like. The material is flexible so as to be atraumatic yet rigid so as to provide support to the balloon <NUM>, particularly when used uninflated. The expander <NUM> comprises a longitudinal segment <NUM> which is aligned with a longitudinal axis <NUM> of the elongate probe shaft <NUM>. The longitudinal segment <NUM> is connected with a pullwire <NUM>, or is continuous to act as a pullwire <NUM>, extending through the probe shaft <NUM>, typically to its proximal end. The expander <NUM> also includes at least one expanding segment <NUM>. <FIG> illustrates an embodiment having two expanding segments <NUM>, one on each side of the longitudinal segment <NUM>. The expanding segments <NUM> are fixedly attached to the longitudinal segment <NUM> at a first location <NUM>, such as at or near its distal tip, and slidably attached at a second location <NUM> proximal to the first location <NUM>. In this embodiment, each expanding segment <NUM> has a hinge, kink point, or flex point <NUM>. Retraction of the pullwire <NUM>, retracts the longitudinal segment <NUM>. As the first location <NUM> is drawn toward the probe shaft <NUM>, the second location <NUM> is restricted from being drawing into the probe shaft <NUM>, therefore causing each expanding segment <NUM> to move laterally outward at its flex point <NUM>, as illustrated in <FIG>. Thus, the flex points <NUM> move in direction perpendicular to the longitudinal axis <NUM>. The expander <NUM> is now in an expanded position, structurally supporting the balloon <NUM>. In embodiments, the flex points <NUM> may be located at a variety of positions to vary the shape of the expander <NUM> in the expanded position. Likewise, each expanding segment <NUM> may include more than one flex point <NUM>.

<FIG> illustrate a similar embodiment of an expander <NUM>. <FIG> illustrates an embodiment having four expanding segments <NUM>, two on each side of the longitudinal segment <NUM>. The expanding segments <NUM> are fixedly attached to the longitudinal segment <NUM> at a first location <NUM>, such as at or near its distal tip, and slidably attached at a second location <NUM> proximal to the first location <NUM>. Here, each expanding segment <NUM> is sufficiently flexible so as to bow without a flex point. Retraction of the pullwire <NUM>, retracts the longitudinal segment <NUM>. As the first location <NUM> is drawn toward the probe shaft <NUM>, the second location <NUM> is restricted from being drawing into the probe shaft <NUM>, therefore causing each expanding segment <NUM> to bow laterally outward, as illustrated in <FIG>. Thus, the expanding segments <NUM> move in a direction perpendicular to the longitudinal axis <NUM>. The expander <NUM> is now in an expanded position, structurally supporting the balloon <NUM>.

<FIG> illustrate the end effector <NUM> embodiment of <FIG> in use. <FIG> illustrates the probe <NUM> is inserted into the nostril NO of the nose N in a collapsed configuration, wherein the expanding segments <NUM> are substantially aligned with the longitudinal axis <NUM>. Once positioned so that the balloon <NUM> is desirably aligned with the target area <NUM> along the wall W of the cul-de-sac CDS, the <NUM> is expanded as illustrated in <FIG>. Here, the pullwire <NUM> is retracted, retracting the longitudinal segment <NUM>. As the first location <NUM> is drawn toward the probe shaft <NUM>, the second location <NUM> is restricted from being drawn into the probe shaft <NUM>, therefore causing each expanding segment <NUM> to move laterally outward at its flex point <NUM>. The probe <NUM> is positioned so that at least one flex point <NUM> contacts the nasal wall W while the probe shaft <NUM> maintains its position in the nostril NO. <FIG> illustrates the at least one flex point <NUM> contacting the target area <NUM> so as to apply pressure thereto, improving therapy to the underlying nerve N2. <FIG> also illustrates at least one flex point <NUM> contacting the septum S to provide a backstop or lateral support to the end effector <NUM>. This may also be used to increase pressure applied to the target area. In embodiments, the expander may have only one expanding segment <NUM> if desired, such as to contact the lateral nasal wall W. In such instances, firmly holding the probe may be sufficient back support. In embodiments, the expander <NUM> may be used in combination with a mechanism for delivery of cryogen to the balloon <NUM>, or the expander <NUM> itself may serve as a cryoline.

<FIG> illustrate an embodiment of a probe <NUM> that provides lateral support to the therapeutic end effector <NUM>. In this embodiment, the probe <NUM> comprises an elongate probe shaft <NUM> sized and configured to be advanceable through a nostril NO of a patient and along a nasal meatus, such as a middle meatus between an inferior and middle turbinate. The shaft <NUM> has a distal end <NUM> and a proximal end (not shown), wherein the end effector <NUM> is disposed at or along its distal end <NUM>. In this embodiment, the end effector <NUM> comprises a non-inflatable sheath or balloon <NUM> mounted on the elongate shaft <NUM>. In this embodiment, the end effector <NUM> is configured for cryotherapy and includes a cryoline <NUM> for delivery of cryogen to deliver cold to a target area for cryoablation or cryomodulation thereto. In this embodiment, the probe <NUM> further includes a lateral support <NUM> which is disposed along the shaft <NUM> in a manner so as to provide support to the balloon <NUM> in a lateral direction when in use. In this embodiment, the lateral support <NUM> comprises an elongate rod <NUM> extending along a side of the probe shaft <NUM>, parallel to a longitudinal axis <NUM>, such as within a lumen or within attachment features. The elongate rod <NUM> has a curved distal end <NUM>. In this embodiment, the distal end <NUM> has a curvature of approximately <NUM> degrees so that the distal end <NUM> is substantially perpendicular to the longitudinal axis <NUM>. However, other curvatures may be used, such as <NUM>-<NUM> degrees. In embodiments, the elongate rod <NUM> is malleable so that the curvature may be adjusted as needed.

In this embodiment, the elongate rod <NUM> is rotatable, advanceable and retractable. <FIG> illustrates an end view of the end effector <NUM> of <FIG> while the elongate rod <NUM> is in various positions. <FIG> illustrates the elongate rod <NUM> positioned so that the distal end <NUM> is parallel with the broad surface of the balloon <NUM>. The elongate rod <NUM> is typically in this position during insertion into the nostril NO so as to minimize dimension. Once the balloon <NUM> is desirably placed near the target area, the elongate rod <NUM> is rotated, as illustrated in <FIG>, so that the distal end <NUM> is substantially perpendicular to the broad surface of the balloon <NUM>. This allows the elongate rod <NUM> to apply force to the balloon <NUM>, as will be illustrated later. <FIG> provides a side view illustration of the end effector <NUM> of <FIG>. As shown, the distal end <NUM> of the elongate rod <NUM> extends laterally outwardly, away from the longitudinal axis <NUM>.

<FIG> illustrates the probe <NUM> of <FIG> in use, treating a target area <NUM> along the cul-de-sac CDS of the nasal cavity. In embodiments, the probe <NUM> is inserted into the nostril NO of the nose N in a collapsed configuration, wherein the elongate rod <NUM> is rotated so that its distal end <NUM> is disposed along a broad surface of the balloon <NUM>. Once positioned so that the balloon <NUM> is desirably aligned with the target area <NUM> along the wall W of the cul-de-sac CDS, the rod <NUM> is rotated so that the distal end <NUM> is moved laterally away from the balloon <NUM>. The distal end <NUM> is positioned against the middle turbinate T2 and/or septum S to provide a backstop or lateral support to the balloon <NUM>. In some embodiments this stabilizes the balloon <NUM> and in other embodiments this also applies pressure to the target area <NUM>, improving therapy to the underlying nerve N2. In embodiments, the distal end <NUM> may be positioned against any suitable tissue so as to provide desired support. Likewise, the elongate rod <NUM> may be rotated by any amount so that the distal end <NUM> is perpendicular to the broad surface of the balloon <NUM> or positioned at any angle in relation to the balloon. Further, the rod <NUM> may be advanced or retracted in relation to the probe shaft <NUM> so as to position the distal end <NUM> at various locations along the balloon <NUM>. In embodiments, the probe shaft <NUM> may tilt slightly within the nostril NO to allow the end effector <NUM> to sufficiently contact the target area <NUM>. However, such tilting is greatly diminished in comparison to such treatment without the lateral support <NUM>.

In some embodiments, the elongate rod <NUM> is advanceable so that the distal end <NUM> is positionable distally, beyond the balloon <NUM>, as illustrated in <FIG>. Again, the elongate rod <NUM> is rotatable so that the distal end <NUM> can be positioned parallel with the broad surface of the balloon <NUM>, as illustrated in <FIG>. The elongate rod <NUM> is typically in this position during insertion into the nostril NO so as to minimize dimension. Once the balloon <NUM> is desirably placed near the target area, the elongate rod <NUM> is rotated, as illustrated in <FIG>, so that the distal end <NUM> extends over the balloon <NUM>, substantially perpendicular to the broad surface of the balloon <NUM> (facing out of the page). This allows the elongate rod <NUM> to apply back support to the balloon <NUM>, as will be illustrated later. <FIG> provides a side view illustration of the end effector <NUM> of <FIG>. As shown, the distal end <NUM> of the elongate rod <NUM> extends over the balloon <NUM>, laterally outwardly, away from the longitudinal axis <NUM>. In this embodiment, the balloon <NUM> is inflatable. <FIG> illustrates the balloon <NUM> in the inflated state. As shown, the balloon <NUM> favors expansion away from the rod <NUM>, the rod <NUM> providing back support and stability for the balloon <NUM>.

<FIG> illustrates the embodiment of <FIG> in use, treating a target area <NUM> along the cul-de-saccul-de-sac CDS of the nasal cavity. In embodiments, the probe <NUM> is inserted into the nostril NO of the nose N in a collapsed configuration, wherein the elongate rod <NUM> is rotated so that its distal end <NUM> is disposed along a broad surface of the balloon <NUM>, as illustrated in <FIG>. Here, the curvature of the rod <NUM> is not visible as the distal end <NUM> is extending into the page. Once positioned so that the balloon <NUM> is desirably aligned with the target area <NUM> along the wall W of the cul-de-saccul-de-sac CDS, the rod <NUM> is rotated so that the distal end <NUM> is moved laterally toward the balloon <NUM>, extending over the distal most end of the balloon <NUM>. The distal end <NUM> is positioned against the lateral nasal wall W, near the target area <NUM>, as illustrated in <FIG>. In embodiments, the distal end <NUM> may be malleable so as to adjust the curvature to accommodate various anatomies. The balloon <NUM> is inflated prior to, after or during positioning of the distal end <NUM> against the lateral wall W. The rod <NUM> directs the balloon <NUM> toward the wall W and provides back support to stabilize the position of the balloon <NUM> and increase contact with the wall W. In some embodiments, the rod <NUM> also assists in applying pressure to the target area <NUM>, improving therapy to the underlying nerve N2. Typically, the rod <NUM> and probe shaft <NUM> maintains position with the nostril NO during the procedure, however it may be appreciated that the probe shaft <NUM> may tilt slightly within the nostril NO to allow the end effector <NUM> to sufficiently contact the target area <NUM>. However, such tilting is greatly diminished in comparison to such treatment without the lateral support <NUM>. Likewise, it may be appreciated that the rod <NUM> may tilt while the probe shaft <NUM> remains in position so as to increase pressure on the balloon <NUM> and/or wall W.

<FIG> illustrates an embodiment of a system <NUM> that assists in guiding and maintaining a therapeutic end effector <NUM> in a lateral direction to reach a target area <NUM> along the cul-de-sac CDS of the nasal cavity. In this embodiment, the system <NUM> comprises a curved stylet or guidewire <NUM> and a catheter <NUM> advanceable over the guidewire <NUM>. The catheter <NUM> includes an inflatable sheath or balloon <NUM>, typically configured for cryotherapy wherein the balloon <NUM> is fillable with cryogen so as to deliver cold to the target area <NUM> for cryoablation or cryomodulation thereto. In this embodiment, the guidewire <NUM> is advanceable through a nostril NO of a patient and along a nasal meatus, such as a middle meatus between an inferior and middle turbinate. The guidewire <NUM> may be pre-curved or malleable to allow the curvature to be determined during the procedure. The curvature may take a variety of forms, but generally causes the catheter <NUM> passed there over to bend toward the lateral wall W, such as to follow the curvature of the cul-de-saccul-de-sac CDS. This allows the balloon <NUM> to be positionable against the lateral wall W, more particularly against the target area <NUM> so as to treat the underlying nerve N2. In addition, the curvature maintains placement of the balloon <NUM> in the desired position and reduces any tendency for the balloon <NUM> to slip out of position during inflation and/or subsequent therapy.

<FIG> illustrates a probe <NUM> similar to probe <NUM> with the end effector comprising of a balloon <NUM>. Probe <NUM> is positioned similar to probe <NUM> above where it is tilted laterally over the inferior turbinate T3 and underneath the middle turbinate T2 and into the cul-de-saccul-de-sac CDS, so that the distal end of the balloon <NUM> makes contact with the posterior aspect of the target area <NUM>. Once the distal portion of the probe is positioned in the cul-de-saccul-de-sac contacting the target area <NUM> and lateral side of the middle turbinate T2, the balloon <NUM> is expanded pressing the remainder of the balloon surface area against the target area <NUM> as the other side of the balloon presses against the lateral side of the middle turbinate T2. The expansion occurs by the pressure build of the exhaust gas of the cryogen. This pressure can be as high as <NUM> MPa (<NUM> psi), but will be tailored to <NUM>-<NUM> kPa (<NUM>-<NUM> psi). Expansion of balloon <NUM> ranges from <NUM>-<NUM>, more probably <NUM>-<NUM>. The balloon <NUM> can be made of non-compliant, compliant, or semi-compliant thin walled materials. In embodiments, a semi-compliant thin walled material such as Nylon or a blend of Nylon is used. The wall thickness may be less than <NUM> (<NUM> ") and further may be less than <NUM> (<NUM> "). The expansion is generated using the cryogen exhaust therefore at the initiation of the cryogen the balloon material sticks preventing the balloon from dislodging or moving from the target area once therapy has begun.

In embodiments, the end effector may include a flexible multi-part inner member that defines the outer shape of outer film of the end effector creating the surface area for treatment. 20A-2D shows an end effector with a multi-part inner member. As shown, the inner member comprises a first member <NUM> and a second member <NUM> within an outer film <NUM>. In embodiments it is desirable to have an end effector with a large surface area, however the dimension of the end effector perpendicular to the longitudinal axis, along the Y axis in Figs. 20A-2D, may be a limiting factor as it must comfortably fit into the nostril and through narrow portions of the nasal cavity prior to reaching the middle meatus. The flexibility of the inner member is configured to bend around rigid structures but is sufficiently stiff to maneuver through the nasal cavity and compress mucosa. In embodiments, first member <NUM> and second member <NUM> are substantially semi-circular in shape. First member <NUM> and second member <NUM> may extend longitudinally away from a distal end of a shaft and then include a curved portion initially curving away from a longitudinal axis of the shaft and then curving toward the longitudinal axis of the shaft. The distal ends of the first member <NUM> and second member <NUM> include bends which form an atraumatic tip to prevent damage to the patient and outer film. As shown, in the y-plane the first member <NUM> and second member <NUM> form a heart shape in the expanded configuration and may have a width of between <NUM> to <NUM>. In embodiments, first member <NUM> and second member <NUM> are configured to be able to bend toward each other and overlap each other when sufficient pressure as applied, as shown in Figs. When overlapped, the dimension perpendicular to the longitudinal axis of the probe is reduced, for example the dimension may be reduced in a range of <NUM> to <NUM>. When overlapped in the compressed configuration, in the y plane that first member <NUM> and second member <NUM> form an oblong shaped profile. The force needed to overlap the first and second members <NUM> and <NUM> may be configured to be a force which is comfortable for the nostril to apply. When the compressed end effector enters the middle meatus the first and second member are biased back to an expanded orientation and the end effector has a larger area than could comfortably be introduced through the nostril with a rigid inner member. The compressing feature of the inner member is achieved by having the first member <NUM> and second member <NUM> shaped with a gap <NUM> between them in the expanded configuration, shown in <FIG>. Further, as shown, first member <NUM> and second member <NUM> are offset so they can compress inwards towards each other or beside each other. In embodiments, the gap <NUM> will range from <NUM>-<NUM>. The inner member can be made of stainless steel or nitinol wire with a diameter < <NUM> (<NUM> ") or high durometer polymer such as nylon <NUM>, TR55, or the like. In embodiments, the inner member is made of stainless steel wire ranging from <NUM>-<NUM> (<NUM>-<NUM>") in diameter. The stainless steel wire is ideal as it leaves the center of the end effector open to minimize the chance of ice crystals being formed and causing blockage of the cryogen line and stainless steel material properties are stable at temperatures below <NUM> deg.

Claim 1:
A telescoping surgical probe (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>) for treating a tissue region within a nasal cavity of a patient, the probe (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>) comprising:
an elongate outer shaft (<NUM>) having a distal end configured for insertion into a nostril of a nasal cavity of a patient, the outer shaft (<NUM>) having a longitudinal axis and lumen (<NUM>) therethrough;
an elongate inner shaft (<NUM>) positioned within the lumen (<NUM>) of the outer shaft (<NUM>) and translatable relative to the outer shaft (<NUM>); and
an end effector (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>) coupled to a distal end of the inner shaft (<NUM>), wherein a distal portion (<NUM>) of the inner shaft (<NUM>) is substantially aligned with the longitudinal axis of the outer shaft (<NUM>) and the end effector (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>) is positioned a first distance (d1) from the distal end of the outer shaft (<NUM>) when the surgical probe (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>) is in a first configuration during insertion and advancement of the surgical probe (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>) into the nasal cavity, wherein the end effector (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>) is attached to the distal portion (<NUM>) of the inner shaft (<NUM>) at an angle relative to a longitudinal axis (<NUM>) of the distal portion (<NUM>) of the inner shaft (<NUM>), and wherein a translation of the inner shaft (<NUM>) relative to the outer shaft (<NUM>) configures the end effector (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>) longitudinally to a second distance (d2) greater than the first distance (d1) away from the distal end of the outer shaft (<NUM>) and laterally away from the longitudinal axis of the outer shaft (<NUM>) when the surgical probe (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>) is in a second configuration, wherein the end effector (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>) in the second configuration is in lateral contact with a tissue region having at least one posterior nasal nerve and is configured to ablate the at least one posterior nasal nerve.