Cryotherapy Systems and Methods Patent Application (2025)

U.S. patent application number 17/617798 was filed with the patent office on 2022-07-28 for cryotherapy systems and methods. The applicant listed for this patent is Arrinex, Inc.. Invention is credited to Brian Fahey, William Jason Fox, Vahid Saadat.

Cryotherapy Systems and Methods

Abstract

In an example, a method for delivering an anesthetic agent to atarget tissue in a nasal cavity of a patient includes inserting acryotherapy device into the nasal cavity of the patient. Thecryotherapy device includes a cryotherapy delivery feature and oneor more protrusions. The method also includes positioning thecryotherapy delivery feature in contact with the target tissue, anddelivering, using the cryotherapy delivery feature, a cryotherapytreatment to the target tissue. After inserting the cryotherapydevice into the nasal cavity, the method includes actuating the oneor more protrusions from a retracted state to an extended state.After actuating the one or more protrusions to the extended state,the method includes penetrating the target tissue with the one ormore protrusions. After penetrating the target tissue, the methodincludes delivering, via the one or more protrusions, an anestheticagent into the target tissue.

Related U.S. Patent Documents

Claims

1. An apparatus for delivering an anesthetic agent to a targettissue in a nasal cavity of a patient, the apparatus comprising: anelongated shaft; an applicator coupled to a distal end of theelongated shaft, wherein the applicator comprises a cryotherapydelivery feature configured to use a cryogen to apply thermalenergy to the target tissue; one or more protrusions coupled to theapplicator, wherein each protrusion comprises a tip that isconfigured to penetrate the target tissue, wherein each protrusionis configured to actuated from a retracted state to an extendedstate, wherein for each protrusion: (i) in the retracted state, thetip of the protrusion is at a first distance from an exteriorsurface of the applicator, (ii) in the extended state, the tip ofthe protrusion is at a second distance from the exterior surface ofthe applicator, and (iii) the second distance is greater than thefirst distance; and one or more lumens extending through theelongated shaft, wherein the one or more lumens are configured totransmit an anesthetic agent from an anesthetic agent to the one ormore protrusions, wherein each protrusion comprises an exit portthat is configured to deliver the anesthetic agent to the targettissue in the nasal cavity.

2. The apparatus of claim 1, wherein the cryotherapy deliveryfeature comprises a balloon.

3. The apparatus of any one of claims 1-2, wherein, when the one ormore protrusions are in the extended state, the one or moreprotrusions extend away from the exterior surface of the applicatorby between about 1 mm to about 4 mm.

4. The apparatus of any one of claims 1-3, further comprising: anscaffolding coupled to the cryotherapy delivery feature, whereinthe scaffolding has a stiffness that is greater than a stiffness ofthe cryotherapy delivery feature, and

5. The apparatus of any one of claims 1-4, wherein the one or moreprotrusions are coupled to the scaffolding.

6. The apparatus of any one of claims 1-5, wherein the one or moreprotrusions extend from a peripheral portion of the applicator.

7. The apparatus of any one of claims 1-6, wherein each protrusionis coupled to the applicator via a hinge such that the protrusioncan actuate from the retracted state to the extended state byrotating, via the hinge, outward away from the exterior surface ofthe applicator.

8. The apparatus of any one of claims 1-7, wherein a length of afirst protrusion of the one or more protrusions in the extendedstate is different than a length of a second protrusion of the oneor more protrusions in the extended state.

9. The apparatus of any one of claims 1-8, wherein a length of eachof the one or more protrusions is different.

10. The apparatus of any one of claims 1-9, further comprising: asheath that is translatable along the elongated shaft between (i) adistal position on the elongated shaft and (ii) a proximal positionon the elongated shaft, wherein, in the distal position, the sheathat least partially covers the applicator and retains the one ormore protrusions in the retracted state, and wherein, in theproximal position, the sheath exposes the applicator and allows theone or more protrusions to be in the extended state.

11. The apparatus of claim 10, wherein the applicator comprises aplurality of arms that expand radially outward from a centralportion when the sheath is in the proximal position, and whereinthe plurality of arms comprise the one or more protrusions.

12. The apparatus of any one of claims 1-11, wherein, for eachprotrusion, the exit port comprises a plurality of exit portslocated along a length of the protrusion.

13. The apparatus of any one of claims 1-12, further comprising: ascaffolding extending around a circumference of the cryotherapydelivery feature, wherein the scaffolding comprises a material thatis thermally conductive and electrically conductive; and one ormore electrical lead wires coupled to the scaffolding andconfigured to couple the scaffolding to an electrical power source,wherein the scaffolding is configured to generate heat responsiveto an electrical current from the electrical power source, andwherein the scaffolding is thermally coupled to the one or moreprotrusions and configured to transfer heat from the scaffolding tothe one or more protrusions.

14. An apparatus for delivering an anesthetic agent to a targettissue in a nasal cavity of a patient, the apparatus comprising: anelongated shaft; an applicator coupled to a distal end of theelongated shaft, wherein the applicator comprises a cryotherapydelivery feature configured to use a cryogen to apply thermalenergy to the target tissue; a needle comprising a tip that isconfigured to penetrate the target tissue, wherein the needle isactuatable between from a retracted state and an extended state,wherein: (i) in the retracted state, the tip of the needle is at afirst distance from the applicator, (ii) in the extended state, thetip of the needle is at a second distance from the applicator, and(iii) the second distance is greater than the first distance; and aneedle guide system configured to facilitate translating the needlebetween the retracted state and the extended state.

15. The apparatus of claim 14, wherein the needle guide systemcomprises: a plurality of guide hooks coupled to the elongatedshaft; and a needle guide ramp at the distal end of the elongatedshaft and configured to bend the needle as the needle movesdistally along the elongated shaft.

16. The apparatus of claim 14, wherein the needle guide systemcomprises a needle guide ramp in an internal cavity of theapplicator.

17. The apparatus of any one of claims 14-16, wherein the elongatedshaft is shaped so that the cryotherapy delivery feature isoff-axis to a central axis of the apparatus.

18. A method for delivering an anesthetic agent to a target tissuein a nasal cavity of a patient, the method comprising: inserting acryotherapy device into the nasal cavity of the patient, whereinthe cryotherapy device comprises a cryotherapy delivery feature andone or more protrusions; positioning the cryotherapy deliveryfeature in contact with the target tissue; delivering, using thecryotherapy delivery feature, a cryotherapy treatment to the targettissue; after inserting the cryotherapy device into the nasalcavity, actuating the one or more protrusions from a retractedstate to an extended state; after actuating the one or moreprotrusions to the extended state, penetrating the target tissuewith the one or more protrusions; and after penetrating the targettissue, delivering, via the one or more protrusions, an anestheticagent into the target tissue.

19. The method of claim 18, further comprising: generating heat ina scaffolding of the cryotherapy device; transferring the heat fromthe scaffolding to the one or more protrusions; and transferringthe heat from the one or more protrusions to the target tissue.

20. The method of claim 19, wherein generating the heat in thescaffolding comprises transducing an electrical current viaresistive heating.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of priority toU.S. Provisional Pat. Appl. No. 62/861,591, filed on Jun. 14, 2019,the contents of which is hereby incorporated by reference in itsentirety. The present applicant is also generally related to U.S.Pat. No. 9,687,288, filed Sep. 30, 2013, U.S. Pat. Publ. No.2017/023147, filed Feb. 13, 2017, and U.S. Provisional ApplicationNo. 62/684,917, filed Jun. 14, 2018, the contents of which arehereby incorporated by reference in their entireties.

FIELD

[0002] The present disclosure is related to the field oftherapeutic thermal interventions and, more particularly, toapparatuses and methods for hypothermic thermal treatments (e.g.,cryotherapies including hypothermic cooling and cryoablation).

BACKGROUND

[0003] In general, thermal therapies involve treating tissue byinducing a temperature change that selectively induces alterationsof the tissue, either temporarily or permanently. Depending on thetissue targeted for treatment, this thermal alteration may providevarious benefits, including treatment of cardiac arrhythmia,destruction of cancerous tissue masses, and/or alteration of nervesignaling pathways. Ablation may be accomplished by applying heat(for example, with radiofrequency, laser, microwave, high intensityfocused ultrasound (HIFU), or resistive heating methods) or byapplying cooling energy (for example, using cryoablationtechniques).

[0004] The term `cryotherapy` describes a class of thermaltherapies that involve inducing a relatively cold temperature in atissue, and includes therapies generally referred to as therapeutichypothermia and cryoablation. Depending on the temperatures andexposure times involved, the clinical goals of variouscryotherapies may range from improved tissue healing/recovery(e.g., as with therapeutic hypothermia employed during physicaltherapy sessions) to selective tissue damage or destruction (e.g.,during cryoablation used for neuromodulation or tumor-destructionpurposes). Any tissue alteration introduced during cryotherapy maybe temporary or permanent, depending on the tissue treated and oneor more characteristics of the therapy applied to the tissue.

[0005] In practice, certain applications of cryotherapy may causediscomfort to a patient during and/or after treatment. For thisreason, a medical practitioner may apply an anesthetic and/or ananalgesic to the patient in tandem with the cryotherapy treatment.Indeed, medical practitioners generally endeavor to achieveadequate pain control when providing modern medical interventions.However, as some cryotherapies have moved away from operating roomsettings (where general anesthesia is available and practical) andinto office-based settings (where only local anesthetics aregenerally available), existing pain control techniques forcryotherapy may be impractical or otherwise non-ideal for someprocedures. Additionally, as medical practitioners have begun usingcryotherapy interventions to target new anatomical regions, thepotential physiological pathways and triggers for pain have alsoshifted, suggesting that improved solution pathways may emerge.Novel techniques, along with novel systems and apparatuses thatenable these techniques, are required.

[0006] Rhinitis is defined as inflammation of the membranes liningthe nose, and is characterized by nasal symptoms including itching,rhinorrhea, and/or nasal congestion. Chronic rhinitis affectsmillions of people and is a leading cause for patients to seekmedical care. Medical treatment has been shown to have limitedeffects for chronic rhinitis sufferers and requires dailymedication use or onerous allergy treatments, and up to 20% ofpatients may be refractory. Selectively interrupting the PosteriorNasal Nerves (PNN), Accessory Posterior Nasal Nerves (APNN), and/orother nervous structures in patients with chronic rhinitis (e.g.,by applying cryotherapy within the nasal cavity to cryoablate thesenerves) has been shown to improve symptoms with limited toelimination of side effects.

[0007] There are a number of possible physiological pathways bywhich the application of cryotherapy within the nasal cavity maylead to discomfort, either during the treatment or in the periodfollowing treatment. The mucosal and submucosal regions of thenasal cavity contain numerous sensory nerve fibers which primarilyoriginate from the first and second branches (V1 and V2) of thetrigeminal nerve (the fifth cranial nerve). Activation of thesesensory nerves by cold stimuli may lead to sensations of pain. Painmay also be induced via an indirect activation of nerve endings,which may be possible via reflex arcs similar to thetrigeminal-autonomic reflex (often associated with migraine,cluster headache, and other syndromes), and/or due to processessuch as trigeminal sensitization, which may result in cold stimuliin the nose leading to discomfort felt in the anterior forehead,teeth/jaw, or in other regions. Additionally, the activation ofreflex arcs leading to cold-stimulus headache (i.e. "ice-creamheadache") is possible in some scenarios, as the cooling of bloodflowing through the treatment region, the cooling ofnasally-inhaled air, and other mechanisms may all triggersignificant cooling of regions that include the soft palate and theposterior pharyngeal wall. An ideal pain management solution wouldcontrol for all pathways of possible discomfort associated with aparticular intervention in order to ensure that a patient has apositive experience. In practice, solutions are needed that balancepracticality, patient tolerance, and effectiveness.

[0008] The response of sensory afferent nerves to cold stimuli iscomplex. Within the nasal cavity, it is generally believed thatthere are at least two types of nerve fibers responsive to coldnoxious stimuli (these fibers are oftentimes called`thermoreceptors`): (i) A-delta fibers, which are thick andmyelinated, and (ii) C fibers, which are thin and unmyelinated.According to a scholarly publication by Wasner and colleagues(Wasner et al, Topical menthol--a human model for cold pain byactivation and sensitization of C nociceptors, Brain 127:1159-1171,2004--incorporated herein by reference), A-delta fibers are thoughtto carry painless cold sensations, whereas C fibers are thought toconduct pain. Again, according to Wasner and colleagues, studiessuggest that cold-specific A-delta fibers may suppress thesensation of pain originating from C fibers, and accordingly theselective inhibition of A-delta fibers may amplify cold-inducedpain. However, A-delta fibers are generally more sensitive than Cfibers to topical anesthetics typically utilized in nasalprocedures, such as lidocaine, tetracaine, and bupivacaine. Assuch, there may be a risk of inadequate anesthesia failing toinhibit pain-producing C fibers while at the same time exacerbatingthe situation by successfully inhibiting the A-delta fibers thathelp suppress these pain sensations. Accordingly, the most suitableapproaches to anesthesia for cryotherapy applied within the nasalcavity will consider this complex response. Novel methods andenabling-devices would benefit this endeavor and improve care forpatients

SUMMARY

[0009] The present disclosure is related to systems, devices, andmethods for applying anesthesia for thermal therapies. Morespecifically, the present disclosure relates to applying localanesthesia for hypothermic treatments of body tissues. Thisdisclosure is particularly useful when treating patients duringoffice-based procedures, or in other situations where generalanesthesia is not available, practical, and/or advisable. Thedisclosure can be particularly useful during cryotherapy proceduresapplied within the upper airway.

[0010] It is an objective of the present disclosure to providemethods, devices, and systems that advance the delivery of localanesthetics with solutions that improve the balance betweensimplicity, practicality, and effectiveness. More specifically, itis an objective of the present disclosure to allow for adequateanesthesia for cryotherapies in the nasal cavity or other bodylumens. Accomplishing this objective is valuable because it willimprove the patient experience when receiving these valuabletreatments which may encourage more patients to elect to receivesaid treatments.

[0011] In an example, an apparatus for delivering an anestheticagent to a target tissue in a nasal cavity of a patient isdescribed. The apparatus includes an elongated shaft and anapplicator coupled to a distal end of the elongated shaft. Theapplicator includes a cryotherapy delivery feature configured touse a cryogen to apply thermal energy to the target tissue. Theapparatus also includes one or more protrusions coupled to theapplicator. Each protrusion includes a tip that is configured topenetrate the target tissue. Each protrusion is configured toactuated from a retracted state to an extended state. For eachprotrusion, (i) in the retracted state, the tip of the protrusionis at a first distance from an exterior surface of the applicator,(ii) in the extended state, the tip of the protrusion is at asecond distance from the exterior surface of the applicator, and(iii) the second distance is greater than the first distance. Theapparatus further includes one or more lumens extending through theelongated shaft. The one or more lumens are configured to transmitan anesthetic agent from an anesthetic agent to the one or moreprotrusions. Each protrusion includes an exit port that isconfigured to deliver the anesthetic agent to the target tissue inthe nasal cavity.

[0012] In another example, an apparatus for delivering ananesthetic agent to a target tissue in a nasal cavity of a patientis described. The apparatus includes an elongated shaft and anapplicator coupled to a distal end of the elongated shaft. Theapplicator includes a cryotherapy delivery feature configured touse a cryogen to apply thermal energy to the target tissue. Theapparatus also includes a needle having a tip that is configured topenetrate the target tissue. The needle is actuatable between froma retracted state and an extended state. In the retracted state,the tip of the needle is at a first distance from the applicator.In the extended state, the tip of the needle is at a seconddistance from the applicator. The second distance is greater thanthe first distance. The apparatus further includes a needle guidesystem configured to facilitate translating the needle between theretracted state and the extended state.

[0013] In another example, a method for delivering an anestheticagent to a target tissue in a nasal cavity of a patient isdescribed. The method includes inserting a cryotherapy device intothe nasal cavity of the patient. The cryotherapy device includes acryotherapy delivery feature and one or more protrusions. Themethod also includes positioning the cryotherapy delivery featurein contact with the target tissue, and delivering, using thecryotherapy delivery feature, a cryotherapy treatment to the targettissue. After inserting the cryotherapy device into the nasalcavity, the method includes actuating the one or more protrusionsfrom a retracted state to an extended state. After actuating theone or more protrusions to the extended state, the method includespenetrating the target tissue with the one or more protrusions.After penetrating the target tissue, the method includesdelivering, via the one or more protrusions, an anesthetic agentinto the target tissue.

[0014] The features, functions, and advantages that have beendiscussed can be achieved independently in various examples or maybe combined in yet other examples further details of which can beseen with reference to the following description and drawings.

BRIEF DESCRIPTION OF THE FIGURES

[0015] The novel features believed characteristic of theillustrative examples are set forth in the appended claims. Theillustrative examples, however, as well as a preferred mode of use,further objectives and descriptions thereof, will best beunderstood by reference to the following detailed description of anillustrative example of the present disclosure when read inconjunction with the accompanying drawings, wherein:

[0016] FIG. 1 illustrates a simplified block diagram of acryotherapy device, according to an example.

[0017] FIG. 2A illustrates a first side of a distal portion of thecryotherapy device of FIG. 1 positioned proximate to a targettissue, according to an example.

[0018] FIG. 2B illustrates a second side of the cryotherapy deviceof FIG. 2A, according to an example.

[0019] FIG. 3 illustrates a distal portion of the cryotherapydevice of FIG. 1, according to another example.

[0020] FIG. 4A illustrates a distal portion of the cryotherapydevice of FIG. 1 with a sheath in a distal position, according toanother example.

[0021] FIG. 4B illustrates the cryotherapy device of FIG. 4A withthe sheath in a proximal position, according to an example.

[0022] FIG. 5A illustrates a distal portion of the cryotherapydevice of FIG. 1 in a covered state, according to anotherexample.

[0023] FIG. 5B illustrates the cryotherapy device of FIG. 5A in apartially exposed state, according to an example.

[0024] FIG. 5C illustrates the cryotherapy device of FIG. 5A in afully exposed state, according to an example.

[0025] FIG. 6 illustrates a distal portion of the cryotherapydevice of FIG. 1, according to another example.

[0026] FIG. 7 illustrates a protrusion for delivering an anestheticagent, according to an example.

[0027] FIG. 8 illustrates a distal portion of the cryotherapydevice of FIG. 1, according to another example.

[0028] FIG. 9A illustrates a distal portion of the cryotherapydevice of FIG. 1 with a needle in a retracted state, according toanother example.

[0029] FIG. 9B illustrates the distal portion of the cryotherapydevice of FIG. 9A with the needle in an extended state, accordingto an example.

[0030] FIG. 9C illustrates a cross-sectional view of thecryotherapy device of FIG. 9A, according to an example.

[0031] FIG. 10 illustrates a distal portion of the cryotherapydevice of FIG. 1, according to another example.

[0032] FIG. 11A illustrates a distal portion of the cryotherapydevice of FIG. 1 with a needle in a retracted state, according toanother example.

[0033] FIG. 11B illustrates a cross-sectional view of thecryotherapy device of FIG. 11A, according to an example.

[0034] FIG. 11C illustrates the distal portion of the cryotherapydevice of FIG. 11A with the needle in an extended state, accordingto an example.

[0035] FIG. 12 illustrates a flowchart for a method of using acryotherapy device, according to an example.

[0036] FIG. 13 illustrates a flowchart for a method of using acryotherapy device that can be used with the method shown in FIG.12, according to an example.

[0037] FIG. 14 illustrates a flowchart for a method of using acryotherapy device that can be used with the method shown in FIG.13, according to an example.

DETAILED DESCRIPTION

[0038] Disclosed examples will now be described more fullyhereinafter with reference to the accompanying drawings, in whichsome, but not all of the disclosed examples are shown. Indeed,several different examples may be described and should not beconstrued as limited to the examples set forth herein. Rather,these examples are described so that this disclosure will bethorough and complete and will fully convey the scope of thedisclosure to those skilled in the art.

[0039] The present disclosure is related to systems, devices, andmethods for applying comfort control for thermal therapies. Morespecifically, the present disclosure relates to applying comfortcontrol for hypothermic treatments of body tissues. The systems,devices, and methods of the present disclosure can be particularlyuseful when delivering thermal-based or other non-thermaltreatments to patients in an office-based setting. Use of thedisclosed methods, devices, and systems can improve management ofpain during and/or following medical treatments.

[0040] Various aspects of the disclosure described herein may beapplied to any of the particular applications set forth below orfor any other types of thermal or non-thermal treatment systems ormethods. The disclosure may be applied as a standalone system ormethod, or as part of an integrated medical treatment system.

[0041] Referring now to FIG. 1, a simplified block diagram of acryotherapy device 100 is shown according to an example. As shownin FIG. 1, the cryotherapy device 100 includes an elongated shaft110 that extends between a proximal portion 112 of the cryotherapydevice 100 and a distal portion 114 of the cryotherapy device 100.The elongated shaft 110 can be configured to be at least partiallyinserted in a nasal cavity of a patient. For example, the elongatedshaft 110 can have a diameter between approximately 1 mm andapproximately 4 mm. Additionally, for example, the elongated shaft110 can be made from stainless Steel and/or semi-rigid polymer(e.g., such as Nylon or Pebax). The elongated shaft 110 can also bemade of a combination of these.

[0042] Although the elongated shaft 110 is shown as being separatefrom the proximal portion 112 and the distal portion 114 in FIG. 1,the proximal portion 112 and/or the distal portion 114 of thecryotherapy device 100 can include respective portions of theelongated shaft 110. More generally, the proximal portion 112 caninclude one or more components of the cryotherapy device 100 thatare located relatively farther away from a target tissue to betreated with cryotherapy during a cryotherapy procedure, and thedistal portion 114 can include one or more components of thecryotherapy device 100 that are located relatively closer to thetarget tissue during the cryotherapy procedure. As used herein, theterm "target tissue" means a tissue that is to be treated withcryotherapy during the cryotherapy procedure.

[0043] The proximal portion 112 can include a handpiece 116, one ormore user control devices 118 (e.g., one or more knobs, one or moretriggers, one-or more buttons, one or more switches, one or morelevers, and/or one or more dials), a cryogen source 120 (e.g., acompressed gas canister and/or a fluid reservoir), and/or otherfeatures.

[0044] Within examples, the handpiece 116 can be configured tofacilitate gripping and manipulating the cryotherapy device 100.For instance, the handpiece 116 can have a shape and/or a size thatcan facilitate a user performing a cryotherapy operation bymanipulating the elongated shaft 110 and the distal portion 114using a single hand. In one example, the handpiece 116 can have ashape and/or a size that facilitates the user holding the handpiece116 in a pistol gripping manner (e.g., the handpiece 116 can havean axis that is transverse to an axis of the elongated shaft 110).In another example, the handpiece 116 can additionally oralternatively have a shape and/or a size that facilitates the userholding the handpiece 116 in a writing utensil gripping manner(e.g., the handpiece 116 can have an axis that is substantiallyparallel to an axis of the elongated shaft 110). Additionally oralternatively, the handpiece 116 can facilitate gripping andmanipulating the cryotherapy device 100 by having a shape and/or asize that is greater than a shape and/or a size of the elongatedshaft 110.

[0045] The cryogen source 120 can store a cryogen 122 such as, forexample, nitrous oxide, liquid carbon dioxide, and/or liquidchlorofluorocarbon. In some implementations, the cryogen source 120can be located in the handpiece 116. This can beneficially providefor a relatively compact size of the cryotherapy device 100 by, forexample, reducing or eliminating relatively long externalconnections (e.g., tubes and/or cables) between the handpiece 116and the cryogen source 120. In other implementations, the cryogensource 120 can be in a housing that is separate from the handpiece116. This can beneficially allow the cryogen source 120 to store arelatively larger amount of the cryogen 122 without impairing thehandling capabilities of the handpiece 116.

[0046] As shown in FIG. 1, the elongated shaft 110 can include oneor more lumens 124. The lumen(s) 124 can include a first end thatis coupled to the cryogen source 120 and a second end that iscoupled to a applicator 126 at the distal portion 114 of thecryotherapy device 100. In this arrangement, the lumen(s) 124 cancouple the cryogen source 120 and the applicator 126.

[0047] Within examples, the user control device(s) 118 can controla flow of the cryogen 122 from the cryogen source 120 to theapplicator 126. For instance, the user control device(s) 118 caninclude one or more knobs, one or more triggers, one-or morebuttons, one or more switches, one or more levers, and/or one ormore dials that can be actuated to start, stop, increase, and/ordecrease a flow of the cryogen 122 from the cryogen source 120 tothe applicator 126. Also, within examples, the user controldevice(s) 118 can be located on the handpiece 116 and/or at alocation that is separate from the handpiece 116.

[0048] As described above, the distal portion 114 includes theapplicator 126. The applicator 126 includes a cryotherapy deliveryfeature 128. In general, the cryotherapy delivery feature 128 isconfigured to use the cryogen 122 to apply thermal energy to thetarget tissue. As such, the cryotherapy delivery feature 128 iscoupled to the cryogen source 120 via the lumen(s) 124). In oneexample, the cryotherapy delivery feature 128 can include a ballooninto which the cryogen 122 (e.g., in the form of a compressedliquid) can expand as a gas. As another example, the cryotherapydelivery feature 128 can include a metallic plate, which can bechilled through contact with the cryogen 122 (e.g., in the form ofa circulating cooled fluid). In these examples, the cryotherapydelivery feature 128 includes an intermediary feature (e.g., theballoon and/or the metallic plate) that transfers the thermalenergy from the cryogen 122 to the target tissue. This canbeneficially help to improve the uniformity of the distribution ofcold temperatures applied across a targeted region of tissue. Thisindirect application of cooling can also prevent cryogen substances(e.g. saline, or other liquids or gases) from direct exposure tothe body in unwanted regions. For example, cold saline applieddirectly to the nasal cavity would run down a patient's throat,causing discomfort and possible tissue injury in unwantedregions.

[0049] In some implementations, the cryotherapy delivery feature128 can have an active surface that is configured for contactingthe target tissue such that relatively little or no thermal energyis applied to tissue regions remote from the active surface. Forexample, the cryotherapy delivery feature 128 can include theactive surface and an inactive surface such that the cryotherapydelivery feature 128 applies the thermal energy to the targettissue contacting the active surface and does not apply the thermalenergy to other tissue contacting the inactive surface. This canhelp to apply thermal energy in a relatively targeted manner totreat a specific target tissue.

[0050] In other implementations, an entirety of the cryotherapydelivery feature 128 can be active such that the cryotherapydelivery feature 128 applies the thermal energy omni-directionally.This can help to apply the thermal energy more broadly and, in someinstances, can help to reduce a time for performing a cryotherapyprocedure.

[0051] Accordingly, in this arrangement, the cryotherapy device 100can be used to perform a cryotherapy procedure on the target tissuein the nasal cavity. For example, in operation, the cryotherapydevice 100 can be inserted in the nasal cavity to position theapplicator 126 at the target tissue (e.g., with the activesurface(s) of the cryotherapy delivery feature 128 contacting thetarget tissue). After the applicator 126 is positioned at thetarget tissue, the user control device(s) 118 can be operated tocause the cryogen source 120 to supply the cryogen 122 to thecryotherapy delivery feature 128 via the lumen(s) 124 extendingthrough the elongated shaft 110. The cryotherapy delivery feature128 of the applicator 126 can use the cryogen 122 to apply thethermal energy to the target tissue to alter the target tissue andtreat one or more conditions.

[0052] Within examples, the cryotherapy device 100 can additionallyapply an anesthetic agent to the target tissue before, during, orafter applying the thermal energy to the target tissue. Forinstance, as shown in FIG. 1, the cryotherapy device 100 canfurther include an anesthetic agent source 130 at the proximalportion 112. The anesthetic agent source 130 can store ananesthetic agent 132. As examples, the anesthetic agent 132 caninclude formulations of lidocaine, marcaine, tetracaine,bupivacaine, cocaine, and/or other anesthetic agents commonlyutilized during medical procedures.

[0053] The anesthetic agent source 130 is coupled to the applicator126 via the lumen(s) 124 extending through the elongated shaft 110.The applicator 126 can include an anesthetic agent delivery feature134 that is configured to deliver the anesthetic agent 132 to thetarget tissue. For example, the anesthetic agent delivery feature134 can include one or more protrusions and/or one or more needlesthat are configured to pierce and penetrate the target tissue.Additionally, for example, the protrusion(s) and/or the needle(s)can include one or more ports that provide for egress of theanesthetic agent 132 from the applicator 126 to the targettissue.

[0054] In some examples, the anesthetic agent source 130 can beseparate from the handpiece 116. For instance, in oneimplementation, the anesthetic agent source 130 can include asyringe that contains the anesthetic agent 132. In thisimplementation, the syringe can be coupled to an infusion port onthe handpiece 116 and a plunger of the syringe can be actuated tosupply the anesthetic agent 132 from the anesthetic agent source130 to the anesthetic agent delivery feature 134 (e.g., via thelumen(s) 124) and from the anesthetic agent delivery feature 134 tothe target tissue. Thus, in this implementation, the anestheticagent source 130 can provide a fluid pressure for delivering theanesthetic agent 132 through the lumen(s) 124 and out theanesthetic agent delivery feature 134 to the target tissue.

[0055] In other examples, the anesthetic agent source 130 can beintegrated with the handpiece 116 and/or actuated by the usercontrol device(s) 118. For instance, in one implementation, theanesthetic agent source 130 can be a disposable reservoir or aresusable reservoir that housed in the handpiece 116. Theanesthetic agent source 130 can also include one or more valvesand/or one or more pumps that facilitate supplying the anestheticagent 132 from the anesthetic agent source 130 to the anestheticagent delivery feature 134 of the applicator 126. The valve(s)and/or the pump(s) can be operable by the user control device(s)118 to start, stop, increase, and/or decrease a flow of theanesthetic agent 132 from the anesthetic agent source 130 to theanesthetic agent delivery feature 134 of the applicator 126.

[0056] Accordingly, in the arrangement shown in FIG. 1, thecryotherapy device 100 can apply a combination of cryotherapy andanesthesia to treat the target tissue. As described above, applyinglocal anesthesia using the anesthetic agent 132 before, during,and/or after applying the thermal energy of the cryotherapyprocedure can beneficially help to improve patient comfort and/orincrease access to types of cryotherapy procedures in office-basedsettings, which may not have been previously available due to alack of general anesthesia capabilities in such office-basedsettings.

[0057] FIGS. 2A-11C show a plurality of distal portions that can beimplemented in connection with the cryotherapy device 100 shown inFIG. 1, according to examples of the present disclosure. Inparticular, FIGS. 2A-11C show various example implementations forthe elongated shaft 110, the applicator 126, the cryotherapydelivery feature 128, and/or the anesthetic agent delivery feature134 shown in FIG. 1. The examples shown in FIGS. 2A-11C will now bedescribed.

[0058] Referring now to FIGS. 2A-2B, a distal portion 214 of acryotherapy device 200 is shown according to an example. Thecryotherapy device 200 is substantially similar or identical to thecryotherapy device 100 shown in FIG. 1. As shown in FIGS. 2A-2B,the cryotherapy device 200 includes an applicator 226 coupled to adistal end 236 of an elongated shaft 210. As described above, theelongated shaft 210 can include the one or more lumens (e.g., thelumen(s) 124) that fluidly couple the applicator 226 to a cryogensource (e.g., the cryogen source 120).

[0059] In FIG. 2A, the applicator 226 is positioned proximate to atarget tissue 238 that is to be treated during a cryotherapyprocedure using the cryotherapy device 200. The applicator 226includes a first side 240, which is positioned facing and incontact with the target tissue 238. As explained in further detailbelow, the first side 240 can include an active surface and thusprovide a treatment side for applying cryotherapy to the targettissue 238. The applicator 226 can also include a second side 242,which is opposite the first side 240. Within examples, the secondside 242 can be an active surface or an inactive surface. FIG. 2Ashows the second side 242 and FIG. 2B shows the first side 240.

[0060] As shown in FIG. 2B, the applicator 226 includes acontainable expandable member 244 in communication with the cryogensource via the lumen(s). Within examples, the expandable member 244can be actuated between a collapsed state and an expanded state.The expandable member 244 can be actuated from the collapsed stateto the expanded state by supplying the cryogen from the cryogensource to the expandable member 244 (e.g., via the lumen(s) 124).Specifically, when the cryogen source is operated (e.g., via theuser control device(s) 118) to supply the cryogen to the expandablemember 244, the expandable member 244 can fill with the cryogen(e.g., a gas from an evaporating liquid cryogen such as nitrousoxide) and expand the expandable member 244 from the collapsedstate to the expanded state. In an example, the expandable member244 can be actuated from the expanded state to the collapsed stateby operating the user control device(s) 118) to cause the cryogensource to cease supplying the cryogen to the expandable member244.

[0061] The expandable member 244 can be configured to transferthermal energy from the cryogen to the target tissue 238. As such,the cryotherapy delivery feature 128 described above can includethe expandable member 244 in the example shown in FIGS. 2A-2B.

[0062] In the collapsed state, the expandable member 244 can have afirst size and/or a first shape. In the expanded state, theexpandable member 244 can have a second size and/or a second shape.The first size and/or the first shape of the expandable member 244in the collapsed state can facilitate inserting the expandablemember 244 to through the nasal cavity to the target tissue.Whereas, the second size and/or the second shape of the expandablemember 244 can help to engage the expandable member 244 with thetarget tissue and/or retain the expandable member 244 in arelatively fixed position at the target tissue. Accordingly, withinexamples, the first size can be less than the second size. In someexamples, the first shape can be the same as the second shape. Inother examples, the first shape can be different than the secondshape. In some implementations the second shape can be based, atleast in part, on a type of tissue that the expandable member 244is configured to engage at the target tissue.

[0063] As shown in FIG. 2B, the applicator 226 can also include ascaffolding 246, which can provide structural rigidity to supportthe expandable member 244 (e.g., the scaffolding 246 can have astiffness that is greater than a stiffness of the expandable member244). Increasing or enhancing the structural rigidity of theapplicator 226 to support the expandable member 244 can assist inmanipulating a position of the applicator 226 with relativelygreater precision and control than may be achieved if theexpandable member 244 omitted the scaffolding 246. This can beparticularly beneficial when manipulating the position of theapplicator 226 when the expandable member 244 is in the collapsedstate (e.g., during insertion of the applicator 226 to the targettissue).

[0064] In FIG. 2B, the scaffolding 246 extends along a longitudinalaxis between a proximal end 240A of the expandable member 244 and adistal end 240B of the expandable member 244. This can assist withstructural support of the expandable member and also providemechanical strength to the distal portion of the cryotherapy device200 to enhance maneuverability of the cryotherapy device 200 withinthe nasal cavity. However, in another example, the scaffolding 246can additionally or alternatively extend in one or more directionsthat are transverse to the longitudinal axis. This can assist withfurther structural support of the expandable member 244, which maylimit unwanted folding of the expandable member 244 that couldoccur as it makes contact with tissues during navigation to thedesired treatment location.

[0065] Also, in FIG. 2B, the scaffolding 246 can be located in aninternal cavity of the expandable member 244. This can help withmaintaining a soft atraumatic surface for the distal portion of thecryotherapy device 200 and also, in some examples, allow for thescaffolding 246 to help deliver the cryogen centrally into theexpandable member 244. However, in other examples, the scaffolding246 can be located on an exterior surface of the expandable member244. This can help to assemble the cryotherapy device 200 during amanufacturing process.

[0066] As examples, the expandable member 244 can be made from oneor more materials including latex, silicone, urethane, and/ornylon. Also, as examples, the scaffolding 246 can be made from oneor more materials including stainless steel, nitinol, and/orcopper. Within examples, the scaffolding 246 has a stiffness thatis greater than the expandable member 244.

[0067] As shown in FIG. 2B, the applicator 226 also includes aplurality of protrusions 248, which can extend from the scaffolding246 near a central portion 250 of the applicator 226. In general,the protrusions 248 may be configured to allow for one or morefluids, one or more gases, and/or other materials to travel alongone or more internal lumens 252 of the protrusions 248. Forinstance, as examples, the protrusions 248 can include a pluralityof needles, cannulas, or other conduits through which the fluid(s),the gas(es), and/or the other material(s) can flow.

[0068] The protrusions 248 can also be configured to penetrate asoft tissue at or proximate to an implantation site (i.e., thetarget tissue 238). For instance, the protrusions 248 can beconstructed from a material having a column strength that allowsthe protrusions 248 to penetrate the target tissue 238 withoutbuckling or otherwise becoming kinked or bent. As examples, theprotrusions 248 can be made from stainless steel and/or nitinol.Also, for instance, the protrusions 248 can have a beveled end thattapers to a point (i.e., similar to the tip of a needle) tofacilitate penetrating the soft tissue and/or one or more frozenregions of the soft tissue (e.g., in instances in which theprotrusions 248 are applied to the target tissue 238 after applyingcryotherapy to the target tissue 238). As examples, to facilitatepenetrating the soft tissue, the protrusions 248 can extendapproximately 1 millimeter (mm) to approximately 4 mm from anexterior surface of the applicator 226.

[0069] Also, within examples, the protrusions 248 can include oneor more exit ports 254 such that the protrusions 248 can deliverthe fluid(s), the gas(es), and/or the other material(s) into thetarget tissue 238, which the protrusions 248 penetrate, or intoother nearby tissues (e.g., tissues that are not penetrated andwhich may not be contiguous with the penetrated tissues). In someexamples, for each protrusion 248, the exit port(s) 254 can belocated at a tip 256 of the protrusion 248. In other examples, foreach protrusion 248, the exit port(s) 254 can be additionally oralternatively located along a body of the protrusion 248 at one ormore positions between the exterior surface of the applicator 226and the tip 256 of the protrusion 248. In one example, when aprotrusion penetrates a tissue, a portion of the exit ports 254 canbe located in the penetrated tissue, whereas another portion of theexit ports 254 can be outside of the penetrated tissue such thatthe anesthetic agent can drip onto other nearby tissues

[0070] In some examples, the protrusions 248 can be actuated from aretracted state to an extended state. In the retracted state, thetips of the protrusions 248 can be positioned adjacent to theexterior surface of the applicator 226 or recessed in a body of theapplicator 226 (i.e., at a position inward of the exteriorsurface). This can assist in providing the applicator 226 with arelatively low profile shape and/or size, which can help tomitigate (or prevent) unwanted tissue damage and/or discomfortwhile inserting the applicator 226 to the target tissue 238.

[0071] In the extended state, the tips 256 of the protrusions 248can project outwardly from the exterior surface of the applicator226. This can facilitate the protrusions 248 penetrating the targettissue 238. Within examples, (i) the tips 256 of the protrusions248 can be at a first distance from the exterior surface of theapplicator 226 when the protrusions 248 are in the retracted state,(ii) the tips 256 of the protrusions 248 can be at a seconddistance from the exterior surface of the applicator 226 when theprotrusions 248 are in the retracted state, and (iii) the seconddistance can be greater than the first distance.

[0072] In one implementation, the protrusions 248 can be initiallyretracted within a body of the applicator 226 when the protrusions248 are in the retracted state, and the protrusions 248 can then bedeployed by a user (e.g., by operating the user control device(s)118 of the proximal portion 112 of the cryotherapy device 100) toproject outwardly when the protrusions 248 are in the extendedstate. In some implementations, the protrusions 248 can projectoutwardly from the body of the applicator 226 (e.g., via aspring-based mechanism that is released by manipulating usercontrol device(s) 118) with a force that is sufficient to penetratethe target tissue 238. For instance, actuating the protrusions 248from the retracted state to the extended state can include piercingand penetrating the target tissue 238 in some examples.

[0073] In another implementation, in the retracted state, theprotrusions 248 can be initially folded against the exteriorsurface such that the first side 240 (i.e., the treatment side) ofthe applicator 226 is substantially flat. In this implementation,the protrusions 248 can actuate from the retracted state to theextended state by rotating (e.g., via a hinge or a joint) outwardaway from the exterior surface of the applicator 226.

[0074] Within examples, the user control device(s) 118 shown inFIG. 1 can be operable to actuate the protrusions 248 between theretracted state and the extended state. As examples, the usercontrol device(s) 118 can include one or more knobs, dials,toggles, buttons, and/or other features that control the mechanicalrelays (e.g. pulleys, springs, etc.) for deploying and retractingthe protrusions 248 between the retracted state and the extendedstate.

[0075] In FIG. 2B, the protrusions 248 extend from the scaffolding246 and the central portion 250 of the applicator 226. This canhelp to effectively deliver an anesthetic agent to the centerportion of the treated area while minimizing the number ofprotrusions and tissue penetration sites.

[0076] However, in other examples, the protrusions 248 can extendfrom other portions of the applicator 226. FIG. 3 shows a distalportion 314 of a cryotherapy device 300 according to anotherexample. As shown in FIG. 3, the cryotherapy device 300 includes anapplicator 326 coupled to an elongated shaft 310 and having anexpandable member 344, as described above. The cryotherapy device300 is substantially similar or identical to the cryotherapydevices 100, 200 described above, except the cryotherapy device 300includes an applicator 326 having a plurality of protrusions 348 inan alternative arrangement. Specifically, in FIG. 3, theprotrusions 348 extend from a peripheral portion 358 of theapplicator 326, which extends around a central portion 350 of theapplicator 326. Positioning the protrusions 348 at and/or aroundthe peripheral portion 358 can help achieve broader delivery of ananesthetic agent, and therefore more complete coverage of a tissueregion.

[0077] Although the protrusions 248 extend from the central portion250 of the applicator 226 in FIG. 2 and the protrusions 348 extendfrom the peripheral portion 358 in FIG. 3, the protrusions 248, 348can extend from the central portion 250 and the peripheral portion358 in other examples.

[0078] Referring now to FIGS. 4A-4B, a distal portion 414 of acryotherapy device 400 is shown according to another example. Asshown in FIGS. 4A-4B, the cryotherapy device 400 includes anapplicator 426 coupled to an elongated shaft 410, as describedabove. The cryotherapy device 400 also includes a sheath 460 thatis translatable along the elongated shaft 410 between (i) a distalposition on the elongated shaft 410 shown in FIG. 4A and (ii) aproximal position on the elongated shaft 410 shown in FIG. 4B. Inthe distal position shown in FIG. 4A, the sheath 460 covers (or atleast partially covers) the applicator 426 (i.e., the cryotherapydevice 400 is in a covered state). Whereas, in the proximalposition shown in FIG. 4B, the sheath 460 exposes the applicator426 (i.e., the cryotherapy device 400 is in an exposed state).

[0079] As shown in FIG. 4B, the applicator 426 can include aplurality of protrusions 448 configured to deliver an anestheticagent (e.g., the anesthetic agent 132) as described above. Withinexamples, the sheath 460 can actuate the protrusions 448 betweenthe retracted state and the extended state described above. Forinstance, when the sheath 460 is in the distal position shown inFIG. 4A, the sheath 460 can apply a force that moves theprotrusions 448 from an extended position (shown in FIG. 4B) to aretracted position in which the protrusions 448 are flattenedagainst the applicator 426 and/or the protrusions 448 are recessedin the applicator 426. This can allow the applicator 426 to have arelatively slim and atraumatic profile, which can help facilitateinserting the applicator 426 in a nasal cavity to a target tissue(e.g., the target tissue 238 in FIG. 2).

[0080] Within examples, to actuate and/or maintain the protrusions448 in the retracted state, the sheath 460 can circumferentiallysurround at least a portion of the applicator 426 adjacent to theprotrusions 448. In some implementations, the sheath 460 can extendaround an entire circumference of the applicator 426.

[0081] As described above, when the sheath 460 is in the proximalposition exposing the applicator 426, the protrusions 448 extendoutwardly from the applicator 426 toward the target tissue. Thus,when the sheath 460 is in the proximal position, the protrusions448 can penetrate the target tissue and deliver the anestheticagent to the target tissue. Within examples, after delivering theanesthetic agent to the target tissue, the sheath 460 can beactuated from the proximal position to the distal position tore-cover the applicator 426 and actuate the protrusions 448 fromthe extended state to the retracted state. Thus, positioning thesheath 460 in the distal position covering the protrusions 448 andthe applicator 426 can additionally or alternatively facilitatewithdrawing the applicator 426 out of the nasal cavity aftercompletion of a procedure.

[0082] As examples, the sheath 460 can be comprised of a relativelysoft and a relatively flexible material such as, for instance,nylon and/or another woven polymer. In other examples, the sheath460 can be additionally or alternatively comprised ofpolytetrafluoroethylene (PTFE), a metallic braid, a metallic coiledribbon, Polyimide, fluorinated ethylene propylene (FEP), and/orPEBAX.

[0083] In some examples, the sheath 460 can be similar to ahypotube adapted to slide along the elongated shaft 410 of thecryotherapy device 400. In some implementations, the cryotherapydevice 400 can include a mechanical adjustment system that isoperable by one or more user control devices (e.g., the usercontrol device(s) 118 in FIG. 1) to adjust a position of the sheath460 on the elongated shaft 410. For instance, in oneimplementation, a position of the sheath 460 can be adjusted by auser operating the one or more user control device(s) (e.g., suchas a dial or toggle on the handpiece 116) that are in mechanicalcommunication with a pulley or other mechanical system coupled tothe sheath 460. In other implementations, the position of thesheath 460 can be adjusted directly by the user grabbing and movingthe sheath 460 proximally and/or distally along the elongated shaft410. Other examples are also possible.

[0084] Referring now to FIGS. 5A-5C, a cryotherapy device 500 isshown according to another example. The cryotherapy device 500 issubstantially similar or identical to the cryotherapy device 400described above with respect to FIGS. 4A-4B, except the cryotherapydevice 500 includes an applicator 526 that is configureddifferently than the applicator 426 shown in FIGS. 4A-4B.

[0085] FIG. 5A shows the cryotherapy device 500 in a covered state,FIG. 5B shows the cryotherapy device 500 in a partially exposedstate, and FIG. 5C shows the cryotherapy device 500 in a fullyexposed state. As shown in FIGS. 5A-5C, the cryotherapy device 500includes the applicator 526 coupled to an elongated shaft 510, asdescribed above. The cryotherapy device 500 further includes asheath 560 that is translatable between (i) a distal position onthe elongated shaft 510 shown in FIG. 5A, and (ii) a proximalposition on the elongated shaft 510 shown in FIG. 5C. As describedabove, when the sheath 560 is in the distal position, the sheath560 covers the applicator 526 and maintains a plurality ofprotrusions 548 in a retracted state. When the sheath 560 is in theproximal position, the sheath 560 exposes the applicator 526 andthe protrusions 548 extend outwardly from the applicator 526 in anextended state.

[0086] In FIGS. 5A-5C, the applicator 526 includes a plurality ofarms 562 extending from a central portion 550 of the applicator526. In this example, the arms 562 include the protrusions 548. Oneor more of the arms 562 are movable about the central portion 550such that the arms 562 can be collapsed to a position substantiallyaligned with a longitudinal axis of the sheath 560 and expanded torespective positions that diverge from the longitudinal axis of thesheath 560 (e.g., the arms 562 can fan out and/or spread out fromeach other). As an example, the arms 562 can be coupled to thecentral portion 550 by one or more hinges (e.g., one or more livinghinges) and/or another pivoting structure.

[0087] In FIG. 5A, when the sheath 560 covers the applicator 526,the sheath 560 can cover the arms 562 and thereby position the arms562 in the positions substantially aligned with the longitudinalaxis of the sheath 560. As shown in FIG. 5B, as the sheath 560moves from the distal position shown in FIG. 5A toward the proximalposition shown in FIG. 5C, the sheath 560 initially exposes aportion of the applicator 526. This causes the arms 562 of theapplicator 526 to begin spreading out from the central portion 550(e.g., fan out and/or move radially away from each other). As shownin FIG. 5C, when the sheath 560 is at the proximal position, thearms 562 further spread out from the central portion 550 (i.e., thearms 564 expand radially outward from the central portion 550).

[0088] In this arrangement, the sheath 560 can actuate the arms 562of the applicator 526 and the protrusions 548 to expand a size ofthe applicator 526 for delivering cryotherapy and/or the anestheticagent, and reduce the size of the applicator 526 for insertingand/or withdrawing the applicator 526 in the nasal cavity.Expanding a size of the applicator 526 can allow for a largertreatment area while minimizing the profile of the cryotherapydevice 500 during insertion and navigation of narrow aspects of thenasal cavity. This can facilitate reaching particular nerves fortreatment.

[0089] In FIGS. 2A-5C, the applicator 226, 326, 426, 526 is shownwith the protrusions 248, 348, 448, 548 of the applicator 226, 326,426, 526 having a common length. However, in other examples, theprotrusions 248, 348, 448, 548 in FIGS. 2A-5C can include aplurality of different lengths. Providing the protrusions 248, 348,448, 548 with a plurality of different lengths can help topenetrate the target tissue 238 at a plurality of different depthsand thus deliver the anesthetic agent 132 to the target tissue 238at the different depths. This can help to achieve robust anestheticcoverage over a relatively broad tissue region.

[0090] As one example, FIG. 6 shows a cryotherapy device 600 thatincludes an applicator 626 having a plurality of protrusions 648 ofa plurality of different lengths (i.e., at least one of theprotrusions 648 has a length that is different than a length ofanother one of the protrusions 648). As examples, the differentlengths of the protrusions 648 can include approximately 1 mm,approximately 2 mm, and approximately 3 mm from an exterior surface664 of the applicator 626. As shown in FIG. 6, the applicator 626is coupled to an elongated shaft 610 and the applicator 626 caninclude a cryotherapy delivery feature 628, as described above. Insome examples, a length of each of the protrusion(s) 648 can bedifferent (i.e., each protrusion 648 can a respective length andall of the respective lengths can be different than eachother).

[0091] As described above, the protrusions 248, 348, 448, 548, 648can include one or more exit ports 254 that can facilitatedelivering the anesthetic agent 132 from the cryotherapy device100, 200, 300, 400, 500, 600 to the target tissue 238. FIG. 2Bshows an example in which the exit port(s) 254 are located at thetips 256 of the protrusions 248. However, as described above, theexit port(s) 254 can additionally or alternatively be located on abody of each protrusion 248, 348, 448, 548, 648 at one or morepositions between the exterior surface of the applicator 226, 326,426, 526, 626 and the tip 256 of the protrusion 248, 348, 448, 548,648.

[0092] As an example, FIG. 7 shows a protrusion 748 that includesone or more exit ports 754 along a body 766 of the protrusion 748.In the example shown in FIG. 7, the exit ports 754 are arranged ina relatively uniform pattern along and around a circumference ofthe body 766 of the protrusion 748. This can help to deliver theanesthetic agent 132 in a relatively uniform manner to the targettissue surrounding the protrusion 748. However, in other examples,the exit ports 754 can be arranged in other patterns. Withinexamples, the pattern of the exit ports 754 can be based on one ormore criteria including, for instance, a type tissue of the targettissue 238, a size of the target tissue 238, a shape of the targettissue 238, a quantity of the protrusions 248, 348, 448, 548, 648,748, and a spacing between the protrusions 248, 348, 448, 548, 648,748.

[0093] In some examples, the cryotherapy devices 100, 200, 300,400, 500, 600 described herein can be configured to adjust and/orcontrol a temperature of the protrusions 248, 348, 448, 548, 648,748 of the cryotherapy device 100, 200, 300, 400, 500, 600, 700.Specifically, the cryotherapy devices 100, 200, 300, 400, 500, 600can be operable to warm the protrusions 248, 348, 448, 548, 648,748 (i.e., apply heat to the protrusions 248, 348, 448, 548, 648,748 to increase the temperature of the protrusions 248, 348, 448,548, 648, 748).

[0094] Increasing the temperature of protrusions 248, 348, 448,548, 648, 748 can provide a number of benefits. For example,increasing the temperature of protrusions 248, 348, 448, 548, 648,748 can facilitate the protrusions 248, 348, 448, 548, 648, 748penetrating the target tissue 238 after applying cryotherapy to thetarget tissue 238 (which may be frozen as a result of thecryotherapy applied to the target tissue 238). Increasing thetemperature of the protrusions 248, 348, 448, 548, 648, 748 canadditionally or alternatively assist in retaining the protrusions248, 348, 448, 548, 648, 748 in the target tissue during or aftercryotherapy is applied to the target tissue 238.

[0095] Additionally or alternatively, it can be beneficial toactively transfer heat from the protrusions 248, 348, 448, 548,648, 748 to the target tissue before, during, or following atreatment. For example, after the target tissue 238 has been frozenas a result of a cryoablation procedure, transferring heat from theprotrusions 248, 348, 448, 548, 648, 748 to the target tissue 238can improve patient comfort.

[0096] Referring now to FIG. 8, a cryotherapy device 800 that isconfigured to apply heat to a plurality of protrusions 848 is shownaccording to another example. As shown in FIG. 8, the cryotherapydevice 800 includes an applicator 826 that is coupled to anelongated shaft 810, as described above. Accordingly, the elongatedshaft 810 can include one or more lumens (e.g., the lumen(s) 124)that couple the applicator 826 to a cryogen source and/or ananesthetic agent source (e.g., the cryogen source 120 and/or theanesthetic agent source 130 in FIG. 1).

[0097] In FIG. 8, the applicator 826 includes a cryotherapydelivery feature 828 in the form of an expandable member 844 (e.g.,a compliant/semi-compliant balloon). As examples, the expandablemember 844 of the cryotherapy delivery feature 828 can beconstructed of silicone, latex, and/or nylon. As described above,the expandable member 844 can be actuated from a collapsed state toan expanded state by supplying the cryogen from the cryogen sourceto the expandable member 844 (e.g., via the lumen(s) 124). In theexpanded state, the expandable member 844 of the cryotherapydelivery feature 828 can use the cryogen to transfer a cold thermalenergy to the target tissue 238 (i.e., apply cryotherapy to thetarget tissue 238).

[0098] Also, in FIG. 8, the applicator 826 includes a scaffolding846, which can provide structural rigidity to support theexpandable member 844. Increasing or enhancing the structuralrigidity of the applicator 826 to support the expandable member 844can assist in manipulating a position of the applicator 826 withrelatively greater precision and control than may be achieved ifthe expandable member 844 omitted the scaffolding 846. Increasingor enhancing the structural rigidity can also help to maintain theexpandable member 844 in a particular size and/or a particularshape when the expandable member 844 is in the collapsed state.This can, for example, help to position a plurality of protrusions848 of the applicator 826 in an a particular arrangement fordelivering the anesthetic agent 132 to the target tissue 238 whilethe expandable member 844 is in the collapsed state.

[0099] As shown in FIG. 8, the scaffolding 846 can be located in aninternal cavity of the expandable member 844 and extend around acircumference of the expandable member 844 at or near outerperipheral edge of the expandable member 844. In this example, thescaffolding 846 is made from one or more materials that areelectrically conductive and thermally conductive (hereinafter"electrically and thermally conductively material(s)"). Forinstance, the scaffolding 846 can include a material that issuitably resistive to generate a relatively high degree of heat inresponse to an electrical current applied to the scaffolding 846.As examples, the scaffolding 846 can be made from stainless steeland/or Nichrome.

[0100] In some examples, an entirety of the scaffolding 846 caninclude the electrically and thermally conductive material(s). Inother examples, a first portion of the scaffolding 846 can be madefrom the electrically and thermally conductive material(s) and asecond portion of the scaffolding 846 can be made from a materialthat is an electrical insulator and/or a thermal insulator (e.g., aplastic material). For instance, in FIG. 8, the scaffolding 846 caninclude a circumferential portion 846A that extends around thecircumference and a central portion 846B that does not extendaround the circumference. In this example, the circumferentialportion 846A is made from the electrically and thermal conductivematerial(s) and the central portion 846B is made from a materialthat is an electrical insulator and/or a thermal insulator. Asdescribed further below, this can help to reduce (or minimize)generating heat at the central portion 846B of the scaffolding 846at or near a location at which the cryogen 122 enters theexpandable member 844.

[0101] In still other examples, the central portion 846B of thescaffolding 846 can be an electrically and thermally conductivematerial that is electrically isolated from the circumferentialportion 846A. For example, the central portion 846B can be coupledto the circumferential portion 846A by one or more non-conductivejoints or connectors 868, electrically isolating the centralportion 846B of the scaffolding 846 from the circumferentialportion 846A.

[0102] As shown in FIG. 8, the scaffolding 846 can also include oneor more fenestrations 870 that allow the cryogen 122 (e.g., acompressed liquid cryogen that will expand into a gas atatmospheric pressure) to enter into the expandable member 844 andcool surrounding structures. As described above, the cryogen 122can enter the cryotherapy device 800 through an intake port of thecryogen source 120 at or proximate to the handpiece 116 (see FIG.1), and when a valve is shifted to be in an open position (e.g.,responsive to operating the user control device(s) 118), thecryogen 122 can travel within the lumen(s) 124 of the elongatedshaft 810 to reach the fenestration(s) 870. When the cryogen 122exits the fenestration(s) 870, the cryogen 122 can expand into agas within the expandable member 844.

[0103] Additionally, in FIG. 8, the applicator 826 can include aplurality of protrusions 848 coupled to the circumferential portion846A of the scaffolding 846. As described above, each protrusion848 can have a tip that is configured to penetrate the targettissue 238 and/or each protrusion 848 can be made from a materialthat sufficient column strength to puncture soft tissue withoutexcessive bending or kinking. Additionally, as described above, theprotrusions 848 can deliver the anesthetic agent 132 from thenanesthetic agent source 130 to the target tissue 238 (e.g., via thelumen(s) 124 in the elongated shaft 110).

[0104] In some examples, the protrusions 848 are comprised of athermally-conductive material, such as stainless steel. In someexamples, the protrusions 848 are comprised of a material that isthermally conductive and has limited electrical conductivity suchas, for example, diamond, glass, silicon, and/or ceramic. In otherexamples, the protrusions 848 can be comprised of a material thatis both thermally conductive and electrically conductive, and theprotrusions 848 can be coupled to the scaffolding 846 via one ormore materials that are thermally-conductive with a high electricalresistivity, thereby substantially electrically-isolating theprotrusions 848 from the scaffolding 846. This can assists intransmitting thermal energy from the protrusions 848 to the targettissue 238 while mitigating (or preventing) transmitting electricalenergy from the protrusions 848 to the target tissue 238.

[0105] As described above, in some examples, the protrusions 848can be actuated between the collapsed state and the extended state.In other examples, the protrusions 848 can substantially maintain afixed position and/or a fixed orientation at all times. Althoughthe protrusions 848 are coupled to the scaffolding 846 in FIG. 8,the protrusions 848 can be coupled to one or more other portions ofthe applicator 826 in other examples. For instance, as one example,one or more of the protrusions 848 can be coupled to thescaffolding 846 near a center of the expandable member 844proximate to the fenestration 870.

[0106] The circumferential portion 846A of the scaffolding 846 iscoupled to two electrical lead wires 872. In FIG. 8, the electricallead wires 872 extend though at least one of the lumen(s) 124 inelongated shaft 810 to reach the handpiece (e.g., the handpiece 116shown in FIG. 1). In some examples, the electrical lead wires 872can be encased in an insulating material except for at theconnection points found at each respective end of the electricallead wires 873. In some examples, the electrical lead wires 872 canbe coupled to the circumferential portion 846A of the scaffolding846 in series or in parallel with a resistor, capacitor, or otherelectrical component.

[0107] Within or proximate to the handpiece, the electrical leadwires 872 can be coupled to opposite polarity terminals of anelectrical power source (e.g., a battery and/or a power inputmodule for adapting wall mains power). Additionally, withinexamples, the user control device(s) 118 shown in FIG. 1 caninclude an electrical switch coupled to the electrical lead wires872 (e.g., in series with the power source), and actuatable betweena first state and a second state. In the first state, theelectrical switch is in an open position so that an electricalcircuit is broken and no electrical current flows along theelectrical lead wires 872 to the scaffolding 846. In the secondstate, the electrical switch completes the electrical circuit andcauses an electrical current to flow from the power source throughthe electrical lead wires 872 to the circumferential portion 846Aof the scaffolding 846. While current is flowing through thescaffolding 846, the scaffolding 846 transduces the electricalcurrent into heat due to resistive heating (also known as Jouleheating).

[0108] As the protrusions 848 and the scaffolding 846 are made fromthermally conductive material(s), the protrusions 848 are thermallycoupled to the scaffolding 846. Thus, responsive to the scaffolding846 transducing the electrical current to the heat, the scaffolding846 transmits the heat to the protrusions 848. Responsive to theheat received from the scaffolding 846, a temperature of theprotrusions 848 increases. The protrusions 848 can further transmitthe heat to the target tissue 238 as described above.

[0109] As described above, in implementations in which the centralportion 846B is electrically isolated from the circumferentialportion 846A of the scaffolding 846, the electrical current doesnot flow to the central portion 846B of the scaffolding 846. Thiscan mitigate (or prevent) a risk of a short of the terminals of theelectrical power source, reducing (or preventing) temperatureelevations in the central portion of the delivery element. Whendesired, a user can operate the user control device(s) 118 toactuate the electrical switch from the second state back to thefirst state, thereby terminating the electrical current in thescaffolding 846 and cease generating the heat.

[0110] As described above, in some examples of the cryotherapydevice 800 can allow for warm temperatures created from resistiveheating of the circumferential portion 846A of the scaffolding 846to reach the protrusions 848 while substantially keeping theprotrusions 848 electrically isolated, thereby eliminating orsubstantially-eliminating any electrical current that could flowthrough the protrusions 848 into materials that the protrusionscontact, for example into the patient's body.

[0111] Preferred examples will be configured such that thecombination of material resistivity and power sourcevoltage/current characteristics will result in mild temperaturerises in the protrusions 848, for example temperature rises of lessthan 10.degree. C. In some implementations, temperature rises inprotrusions 848 can be equal to or less than approximately 1 degreeCelsius to approximate 3 degrees Celsius. In general, thecryotherapy device 800 can be configured such that temperaturerises induced by resistive heating do not melt or otherwise alterthe expandable member 844 (or any other temperature sensitiveelement of the cryotherapy device 800).

[0112] Within examples, the cryotherapy device 800 can be operableto deliver the heat to the protrusions 848 before, during, and/orafter insertion of the protrusions 848 into the target tissue 838.In some examples, the cryotherapy device 800 can warm theprotrusions 848 only prior to inserting the protrusions 848 intothe target tissue 838. In other examples, the cryotherapy device800 can warm the protrusions 848 only after inserting theprotrusions 848 in the target tissue 838. Warming the protrusions848 can help to reduce a treatment time and improve a workflow fora physician.

[0113] Also, within examples, the user control device(s) 118(including the electrical switch) can be operable to supply theelectrical current from the electrical power source to thescaffolding 846 such that the scaffolding generates the heatcontinuously or intermittently in response to operation of the usercontrol device(s) 118. For instance, in one example, the electricalpower source can include a pulse width modulator that can convert adirect current power into a pulsed electrical signal. Otherexamples are also possible. In some implementations, providingcontinuous power can generate heat faster than pulsed power.However, pulsed power can provide a more gradual and more uniformtemperature rise (and may additionally or alternatively provide forusing a relatively lower-grade battery and/or drive system).

[0114] In some examples, the cryotherapy device 800 can include oneor more sensors (e.g., one or more temperature sensors and/or oneor more conductivity sensors) located the protrusions 848 or inanother location on the cryotherapy device 800. In such examples,the sensor(s) can assist with determining whether or not theprotrusions 848 have contacted and/or penetrated the target tissue238, and/or whether warming should be enabled or disabled. Forexample, a conductivity sensor can measure the electrical impedancebetween different locations on a protrusion 848, or the electricalimpedance between two or more protrusions 848, and compare theresult to a threshold value that has been pre-programmed. Based onthe comparison, the cryotherapy device 800 can determine that theprotrusion 848 has penetrated tissue. This can help to mitigate ascenario where the protrusions 848 are warmed when the protrusions848 are not in the desired or anticipated anatomical position,which could impact the efficacy of the procedure and/or have otherunintended consequences.

[0115] As described above, the distal portion 914 is animplementation of the distal portion 114 of the cryotherapy device100 shown in FIG. 1. In the examples described above, theprotrusions 248, 348, 448, 548, 648, 848 generally extend from theapplicator 226, 326, 426, 526, 626, 826 and the protrusions 248,348, 448, 548, 648, 848 can be fluidly coupled to the anestheticagent source 130 via at least one of the lumen(s) 124 in theelongated shaft 110 shown in FIG. 1. However, in other examples,the protrusions 248, 348, 448, 548, 648, 848 can be located atother locations of the cryotherapy device 100, 200, 300, 400, 500,600, 800 and/or the protrusions 248, 348, 448, 548, 648, 848 can becoupled to the anesthetic agent source 130 by one or more conduitsthat are external to the elongated shaft 110.

[0116] Referring now to FIGS. 9A-9C, a distal portion 914 of acryotherapy device 900 is shown according to another example. Inparticular, FIG. 9A shows the cryotherapy device 900 with a needle948 in a retracted state, FIG. 9B shows the cryotherapy device 900with the needle in an extended state, and FIG. 9C shows across-sectional view of the cryotherapy device 900.

[0117] As shown in FIGS. 9A-9C, the cryotherapy device 900 includesan applicator 926 coupled to an elongated shaft 910, and theapplicator 926 includes a cryotherapy delivery feature 928. Asdescribed above, the cryotherapy delivery feature 928 can becoupled to the cryogen source 120 via the lumen(s) 924 in theelongated shaft 910. Also, as described above, the cryotherapydelivery feature 928 can include an expandable member and/or anactive surface (e.g., made from a metal) that can use the cryogen122 to transfer cold thermal energy to the target tissue. Inanother example, the cryotherapy delivery feature 928 can include athermoelectric device that is configured to generate cold thermalenergy (e.g., via the Peltier effect or a similar process).

[0118] As shown in FIGS. 9A-9B, the cryotherapy device 900 alsoincludes the needle 948, which can deliver the anesthetic agent 132to the target tissue. For example, the needle 948 can include aninternal lumen 924 (FIG. 9C) that extends between a tip 956 at adistal end of the needle 948 and the anesthetic agent source 130 ata proximal end of the needle 948. As described above, the tip 956can be configured to pierce and penetrate the target tissue suchthat the needle 948 can deliver the anesthetic agent 132 to thetarget tissue. For instance, the tip 956 can have a shape thattapers inwardly to a point.

[0119] For instance, the needle 948 can have a gauge between 25gauge and 30 gauge. Additionally, for instance, the needle 948 canbe comprised of a material that retains sufficient column strengthto puncture soft tissue without bending and/or kinking (e.g.,nitinol or thin walled stainless steel tubes).

[0120] In FIGS. 9A-9B, the needle 948 extends along an exteriorsurface of the elongated shaft 910. More specifically, the needle948 is translatable along the elongated shaft 910 between aproximal position shown in FIG. 9A and a distal position shown inFIG. 9B. As shown in FIG. 9A, the tip 956 of the needle 948 can bepositioned proximal of a distal end 936 of the elongated shaft 910in the proximal position (i.e., when the needle 948 is theretracted state). As shown in FIG. 9B, the tip 956 of the needle948 can be positioned distal of the distal end 936 of the elongatedshaft 910 in the distal position (i.e., when the needle 948 is theextended state).

[0121] More generally, (i) in the retracted state shown in FIG. 9A,the tip 956 of the needle 948 can be at a first distance from theapplicator 926, (ii) in the extended state shown in FIG. 9B, thetip 956 of the needle 948 can be at a second distance from theapplicator 926, and (iii) the second distance can be greater thanthe first distance.

[0122] In this arrangement, the needle 948 can be in (i) theretracted position while inserting the cryotherapy device 900 in anasal cavity and withdrawing the cryotherapy device 900 from thenasal cavity, and (ii) in the extended position while penetratingand delivering the anesthetic agent 132 to the target tissue.

[0123] To facilitate translating the needle 948 between theretracted state and the extended state, the cryotherapy device 900can include a needle guide system. For example, in FIGS. 9A-9B, thecryotherapy device 900 includes a plurality of guide hooks 974along the exterior surface of the elongated shaft 910. In FIGS.9A-9C, the guide hooks 974 are coupled to the elongated shaft 910such that the guide hooks 974 and the exterior surface of theelongated shaft 910 define a plurality of apertures 976 that areaxially aligned with each other. Although the apertures 976 aredefined by a combination of the guide hooks 974 and the elongatedshaft 910 in FIGS. 9A-9C, the apertures 976 can be defined by onlythe guide hooks 974 in other examples.

[0124] As shown in FIGS. 9A-9C, the needle 948 extends through oneor more of the apertures 976 defined by the guide hooks 974 in theretracted state and the extended state. In this arrangement, theguide hooks 974 can assist in retaining the needle 948 in a planethat is substantially parallel to a plane in which the elongatedshaft 910 is positioned when the needle 948 is in the retractedstate. The guide hooks 974 can also assist in retaining the needle948 against the elongated shaft 910 while translating the needle948 from the proximal position shown in FIG. 9A to the distalposition shown in FIG. 9B. Thus, the guide hooks 974 can define afirst portion of a path for translating the needle 948 along anaxis of extending through the apertures 976, which is substantiallyparallel to a longitudinal axis of the elongated shaft 910.

[0125] As shown in FIGS. 9A-9B, the needle guide system can alsoinclude a needle guide ramp 978 at or near the distal end of theelongated shaft 910. In general, the needle guide ramp 978 can beconfigured to guide the needle 948 along a second portion of thepath that is transverse to the first portion of the path (i.e.,defined by the axis extending through the apertures 976). In otherwords, the needle guide ramp 978 can be configured to bend theneedle 948 as the needle 948 moves distally through the guide hooks974 and along the elongated shaft 910 (i.e., diverting the tip 956of the needle 948 from the axis of the apertures 976). This canbeneficially help to direct the tip 956 of the needle 948 away fromthe elongated shaft 910 and/or towards the target tissue.

[0126] For example, as shown in FIGS. 9A-9B, a first end of theneedle guide ramp 978 can located in-line with the axis of theapertures 976 and the needle guide ramp 978 can bend towards asecond end of the needle guide ramp 978, which is located outwardof the first end relative to the elongated shaft 910. In thisarrangement, the needle guide ramp 978 can direct the needle 948along a plane transverse to the plane of the elongated shaft 910.This can also help to deliver the anesthetic agent 132 to a portionof the target tissue that is adjacent to another portion of thetarget tissue to which the cryotherapy delivery feature 928 appliesthe cold thermal energy during cryotherapy.

[0127] As shown in FIG. 9A, the needle guide ramp 978 can extendover the tip 956 of the needle 948 when the needle 948 is at theproximal position. This can help to inhibit (or prevent) the needle948 piercing and/or penetrating a tissue other than the targettissue while inserting the cryotherapy device 900 and/or whilewithdrawing the cryotherapy device 900 from the nasal cavity.

[0128] In FIG. 9C, the elongated shaft 910 has a circularcross-sectional shape. However, in another example, the exteriorsurface of elongated shaft 910 can include a hemi-cylindricalrecess in which the needle 948 can be positioned. Thehemi-cylindrical recess can allow for the needle 948 to translatealong the elongated shaft 910 while reducing (or minimizing) acontribution of the needle 948 to an outer diameter of thecryotherapy device 900.

[0129] In some implementations, the needle 948 can be an integralcomponent of the cryotherapy device 900 that can be moved along theelongated shaft 910. That is, the needle 948 can be coupled to theguide hooks 974 such that the needle 948 cannot be removed from theguide hooks 974. In other implementations, the needle 948 can be aseparate component of a cryotherapy device 900 that can berepeatedly inserted into and/or removed from the guide hooks 974,and/or replaced by another needle 948. This can help to provide forthe applicator 926 as a reusable component, and the needle 948 as asingle-use component.

[0130] FIG. 10 shows a cryotherapy device 1000 according to anotherexample. The cryotherapy device 1000 is substantially similar oridentical to the cryotherapy device 900 of FIG. 9, except thecryotherapy device 900 includes a needle 1048 that is internal toan applicator 1026 and an elongated shaft 1010. The applicator 1026is coupled to the elongated shaft 1010, and includes a cryotherapydelivery feature 1028 as described above. As shown in FIG. 10, thecryotherapy device 1000 also includes a needle guide ramp 1078 inan internal cavity of the applicator 1026. As described above, theneedle guide ramp 1078 is configured to divert the needle 1048 froma first portion of a path along an axis (e.g., a longitudinal axisof the elongated shaft 1010) to a second portion of the pathtransverse to the axis. Specifically, in FIG. 10, the needle 1048protrudes from the cryotherapy delivery feature 1028 at an anglethat is substantially normal to a surface of the cryotherapydelivery feature 1028. This can help to apply the anesthetic agent132 and the cool thermal energy to a common portion of the targettissue.

[0131] In FIG. 10, the needle 1048 is shown in an extendedposition. However, the needle 1048 can be translatable along thepath defined by the needle guide ramp 1078 and the longitudinalaxis of the elongated shaft 1010. In the retracted position, theneedle 1048 can be positioned such that a tip 1056 of the needle1048 is not exposed (i.e. the tip 1056 can be recessed within theapplicator 1026).

[0132] Referring now to FIGS. 11A-11C, a cryotherapy device 1100 isshown according to another example. Specifically, FIG. 11A shows adistal portion 1114 of the cryotherapy device 1100 (i) having aneedle 1048 in a retracted state and (ii) in contact with a targettissue 1138 (e.g. upper airway mucosa/submucosa) overlying asemi-rigid structure 1180 (e.g. cartilage or bone). FIG. 11B showsa cross-sectional view of the cryotherapy device 1100 shown in FIG.11A. FIG. 11C shows the distal portion 1114 of the cryotherapydevice 1100 (i) having the needle 1048 in an extended state and(ii) in contact with the target tissue 1138 overlying thesemi-rigid structure 1180.

[0133] The cryotherapy device 1100 includes a cryotherapy deliveryfeature 1128 that can deliver cryotherapy to the target tissue1138. The cryotherapy device 1100 also includes an elongated shaft1110 coupling the cryotherapy delivery feature 1128 to a handpiece(e.g., the handpiece 116). The elongated shaft 1110 is shaped sothat the cryotherapy delivery feature 1128 is off-axis to a centralaxis of the cryotherapy device 1100 (i.e., a longitudinal axis ofthe elongated shaft 1110 is in a different plane than alongitudinal axis of the cryotherapy delivery feature 1128). Tofacilitate shaping the elongated shaft 1110, the elongated shaft1110 can be (i) semi-flexible and pre-shaped by a manufacturer,(ii) constructed of malleable material so shape can be defined bythe user, and/or (iii) comprised of a multi-flexible shaft witharticulating features that allow the user to flex and bend theelongated shaft 1110 during delivery and adjust a shape while theelongated shaft 1110 is in the patient. For instance, the elongatedshaft 1110 can be made from a material that can be manipulated toadjust a shape of the elongated shaft 1110 and then retain theshape after being manipulated.

[0134] As shown in FIGS. 11A-11C, the cryotherapy device 1100 caninclude a needle guide system to assist translating the needle 1048between the retracted state and the extended state, as describedabove. For instance, in FIGS. 11A-11C, the cryotherapy device 1100can include a needle conduit 1182 coupled to the elongated shaft1110. The needle conduit 1182 can have a size and a shape thatallows the needle 1048 to be positioned and translate in the needleconduit 1182. In one example, the needle 1148 can have a gaugebetween 25 gauge and 30 gauge (e.g., the needle 1148 can be arelatively thin-walled metallic tube). Also, as an example, theneedle conduit 1182 can have a diameter that is betweenapproximately 0.05 mm and approximately 0.15 mm larger than anouter diameter of the needle 1148. This can help ensure that theneedle 1148 can translate through the needle conduit 1182 whilestill providing the needle 1148 with a diameter that can achievesufficient column support to facilitate piercing and penetratingthe target tissue 1138.

[0135] In an example, the needle conduit 1182 can be comprised ofshapeable material such as, for instance, a heat shaped polymer. Inone implementation, the needle conduit 1182 and a jacket of theelongated shaft 1110 can be made from a single extrudedmulti-lumen. A distal end of the needle conduit 1182 can beproximal of the cryotherapy delivery feature 1128 and a proximalend of the needle conduit 1182 can be at the handpiece (e.g., thehandpiece 116).

[0136] As shown in FIG. 11B, the needle conduit 1182 and the needle704 are aligned in the opposite plane of a bend in the elongatedshaft 1110 (e.g., the needle 704 can be on top or on bottom of theelongated shaft 1110 and have a shape that corresponds to the bendof the elongated shaft 1110). The elongated shaft 1110 can includean outer lumen 1124A and an inner lumen 1124B, which is concentricwith and inside of the outer lumen 1124A. In the inner lumen 1124Bis a cryogen lumen 1124C that can deliver a cryogen (e.g., thecryogen 122) to the cryotherapy delivery feature 1128. In thisexample, an exhaust from the cryogen can return proximally throughthe inner lumen 1124B.

[0137] In FIG. 11B, the outer lumen 1124A and the inner lumen 1124Bare separated by a gap. The gap can provide insulation along theelongated shaft 1110 to help reduce (or prevent) the elongatedshaft 1110 and the needle conduit 1182 from decreasing intemperature to a temperature level that may ablate tissue outsideof the target tissue 1138. The gap can also help inhibit (orprevent) an anesthetic agent (e.g., the anesthetic agent 132) inneedle 1148 from freezing.

[0138] As noted above, FIG. 11A shows the needle 1148 in theretracted state and FIG. 11C shows the needle 1148 in the extendedstate. As shown in FIG. 11A, when the needle 1148 is in theretracted state, the needle 1148 can be completely retracted withinthe needle conduit 1182, allowing the cryotherapy delivery feature1128 to make contact with the target tissue without piercing thetarget tissue 1138. As shown in FIG. 11C, when the needle 1148 isin the extended state, a tip 1156 of the needle 1148 is advancedmore distally into the target tissue 1138.

[0139] In some implementations, the needle 1148 can be an integralcomponent of the cryotherapy device 1100 that can be moved alongthe elongated shaft 1110. That is, the needle 1148 can be coupledto the needle conduit 1182 such that the needle 1148 cannot beremoved from the needle conduit 1182. In other implementations, theneedle 1148 can be a separate component of a cryotherapy device1100 that can be repeatedly inserted into and/or removed from theneedle conduit 1182, and/or replaced by another needle in theneedle conduit 1182.

[0140] Referring now to FIG. 12, a flowchart of a method 1200 fordelivering an anesthetic agent to a target tissue in a nasal cavityof a patient is shown according to an example. As shown in FIG. 12,the method 1200 can include inserting a cryotherapy device into thenasal cavity of the patient at block 1210. The cryotherapy devicecan include a cryotherapy delivery feature and one or moreprotrusions. At block 1212, the method 1200 can include positioningthe cryotherapy delivery feature in contact with the target tissue.At block 1214, the method 1200 can include delivering, using thecryotherapy delivery feature, a cryotherapy treatment to the targettissue. After inserting the cryotherapy device into the nasalcavity at block 1210, the method 1200 can include actuating the oneor more protrusions from a retracted state to an extended state atblock 1216. After actuating the one or more protrusions to theextended state at block 1216, the method 1200 can includepenetrating the target tissue with the one or more protrusions atblock 1218. After penetrating the target tissue at block 1218, themethod 1200 can include delivering, via the one or moreprotrusions, an anesthetic agent into the target tissue.

[0141] In some examples, penetrating the target tissue at block1218 can be performed prior to delivering the cryotherapy treatmentat block 1214. This can help to reduce a force for penetrating thetarget tissue as the target tissue can become more difficult topenetrate after delivering the cryotherapy to the target tissue. Insome implementations, the protrusions can remain in the targettissue while delivering the cryotherapy and for at least a periodof time after delivering the cryotherapy at block 1214. This canallow for a plurality of modes of operation (e.g., applyinganesthesia prior to cryotherapy and then warming (with or withoutadditional anesthesia after cryotherapy). In other examples,penetrating the target tissue at block 1218 can be performed onlyafter delivering the cryotherapy at block 1214. This may bebeneficial in instances in which the protrusions may interfere withcryotherapy. In some examples, the method 1200 can includedelivering the cryotherapy treatment at block 1214 and deliveringthe anesthetic agent at block 1218 simultaneously.

[0142] FIGS. 13-14 depict additional aspects of the method 1200according to further examples. As shown in FIG. 13, the method 1200can also include (i) generating heat in a scaffolding of thecryotherapy device at block 1220, (ii) transferring the heat fromthe scaffolding to the one or more protrusions at block 1222, and(iii) transferring the heat from the one or more protrusions to thetarget tissue at block 1224. As shown in FIG. 14, generating theheat in the scaffolding at block 1220 can include transducing anelectrical current via resistive heating at block 1226.

[0143] In the examples described above, the method 1200 involvesdelivering the anesthetic agent to the target tissue via theprotrusions. However, in other examples, the method 1200 caninclude delivering a non-pharmaceutical agent is delivered to thetarget tissue. As examples, the non-pharmaceutical agent caninclude water or saline.

[0144] In some examples of methods or devices described herein, thecryotherapy device can be adapted such that the insertion ofprotrusions such as needles into tissues can be gradual with timeand/or performed at an adjustable length based upon a user action.For example, rotating a dial or otherwise manipulating a controlfeature on or proximate to a device handpiece can slowly expand ordeploy a needle protrusion into tissue, allowing for precisecontrol of penetration depth and thereby precise control over thedepth and types of tissue impacted by the therapies delivered viathe protrusions.

[0145] In some examples of the methods or devices described herein,the protrusions at the distal end of the device are adapted toprovide cooling and in effect serve as the cryotherapy deliveryelement(s). In some examples, the protrusions can be adapted todeliver both cooling and heating energy based upon a user input orthe user manipulating a control feature proximate to the handpieceof the device.

[0146] Though the disclosures presently-disclosed have primarilybeen discussed in the context of cryotherapy, the devices, systems,and methods described can have applicability with other ablativeand non-ablative surgical techniques. For example, examples caninclude devices, systems, and methods that utilizeheating/hyperthermia therapies. Examples utilizingheating/hyperthermia therapies can be similar in structure andsteps as examples utilizing hypothermic therapies. Sources of heatfor use with hyperthermia-based therapies can include RF energy,microwave energy, ultrasound energy, resistive heating, exothermicchemical reactions, combinations thereof and other heat sourcesknown to those skilled in the art. Further, the disclosure can beapplied as a standalone system or method, or as part of anintegrated medical treatment system. It shall be understood thatdifferent aspects of the disclosure can be appreciatedindividually, collectively, or in combination with each other.

[0147] The methods described herein can be utilized effectivelywith any of the examples or variations of the devices and systemsdescribed above, as well as with other examples and variations notdescribed explicitly in this document. The features of any of thesystems or system components described in any of the examplesherein can be used in any other suitable example of a system orsystem component.

[0148] The description of the different advantageous arrangementshas been presented for purposes of illustration and description,and is not intended to be exhaustive or limited to the examples inthe form disclosed. Many modifications and variations will beapparent to those of ordinary skill in the art. Further, differentadvantageous examples may describe different advantages as comparedto other advantageous examples. The example or examples selectedare chosen and described in order to explain the principles of theexamples, the practical application, and to enable others ofordinary skill in the art to understand the disclosure for variousexamples with various modifications as are suited to the particularuse contemplated.

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