Method and device for image guided post-nasal nerve ablation

Devices and methods for treating rhinitis are provided. An integrated therapy and imaging device is provided for single handheld use. The device may have a hollow elongated cannula, a therapeutic element coupled to a distal portion of the cannula, an imaging assembly coupled to the cannula to provide visualization of the therapeutic element, and an articulating region operably coupled to the imaging assembly to articulate the imaging assembly. The imaging assembly may be articulated so as to translate vertically, laterally, axially, and/or rotationally.

BACKGROUND OF THE INVENTION

Field of the Invention

The major symptoms of allergic or non-allergic chronic rhinitis are sneezing, rhinorrhea, and night time coughing which are brought about by mucosal swelling, hyper-responsiveness of the sensory nerves, and an increased number and augmented responses of secretory cells in the inferior turbinates, respectively. In particular, chronic severe nasal obstruction resulting from remodeling of submucosal tissues of the inferior turbinates due to dilation of the venous sinuses or fibrosis can interfere with the quality of life (QOL).

One strategy is the surgical treatment of chronic rhinitis; that is to physically eliminate the tissue of the inferior turbinate. Removal or ablation of the mucosal tissue including the surface epithelial layer has the disadvantage of postoperative complications such as crusting and an increased infection rate. Cauterization of the surface epithelia of the inferior turbinate using electrocautery, cryosurgery, or laser yields only short-term benefits to nasal breathing. Submucosal diathermy or cryosurgery also shows only a short-term effect. Turbinectomy is thought to have the greatest effect on nasal obstruction, and slight improvement in some rhinitis patients but it is accompanied by severe adverse effects such as bleeding, crusting, and nasal dryness.

Golding-Wood, who recommended cutting the parasympathetic nerve fibers in the vidian canal to decrease the parasympathetic tone to the nasal mucosa, introduced a different approach for the treatment of hypersecretion in 1961. Various approaches to the vidian canal were subsequently developed, and the method was widely employed in the 1970s. However, the original technique was abandoned at the beginning of the 1980s because of its irreversible complications such as dry eyes.

The pterygoid canal carries both parasympathetic and sympathetic fibers, namely the vidian nerve, to the sphenopalatine ganglion. Subsequently, these autonomic fibers, which relay in the sphenopalatine ganglion, reach the nasal mucosa through the sphenopalatine foramen as the posterior nasal nerve. Resection of the posterior nasal nerve has the effect of both parasympathetic and sympathetic resection in the nasal mucosa, similar to vidian neurectomy. In addition, this procedure, in which somatic afferent innervation to the nasal mucosa is also interrupted, can be expected to reduce the hypersensitivity and axon reflexes of the nasal mucosa. The posterior nasal nerve, which follows the sphenopalatine artery and vein, arises within the sphenopalatine foramen and can be easily identified. Furthermore, selective interruption of the posterior nasal nerves has no complications, like those of vidian neurectomy, since the secretomotor supply to the lacrimal gland and the somatosensory supply to the palate are intact, and overpenetration of the pterygoid canal does not occur.

Posterior nasal neurectomy, initially developed by Kikawada in 1998 and later modified by Kawamura and Kubo, is a novel alternative method in which neural bundles are selectively cut or cauterized from the sphenopalatine foramen. Autonomic and sensory nerve fibers that pass through the foramen anatomically branch into the inferior turbinate and are distributed around the mucosal layer. Therefore, selective neurectomy at this point enables physicians to theoretically avoid surgical complications such as inhibition of lacrimal secretion.

In some cases, it may be beneficial to deliver energy to treat tissue. For example, it may be beneficial to treat rhinitis by delivering energy to the nasal cavity to ablate posterior nasal nerves. However, it can be difficult to deliver energy to the correct location without direct or indirect visualization. Current methods of delivering energy to tissue in the body require using an energy delivery device and a separate device (such as a flexible or rigid endoscope) for direct or indirect visualization. Such visualization devices are expensive, bulky, and difficult to operate simultaneously with energy delivery devices. For example, using an energy delivery device with a rigid endoscope may require the healthcare provider to use both hands, or may require a second individual to perform the procedure, which may make the procedure more time consuming and costly. Moreover, separate rigid or flexible endoscopes and existing visualization devices may not allow a healthcare provider to access far enough into the target anatomy. Accordingly, improved methods and devices are desired.

SUMMARY OF THE INVENTION

There are three nerve bundles innervating the superior, middle and inferior turbinates. The posterior, superior lateral nasal branches off of the maxillary nerve (v2) innervate the middle and superior turbinates. A branch of the greater palatine nerve innervates the inferior turbinate. Ablating these nerves leads to a decrease in or interruption of parasympathetic nerve signals that contribute to rhinorrhea in patients with allergic or vasomotor rhinitis. The objective of this invention is to design a device and method for ablating one or more of these three branches to reduce or eliminate rhinitis.

The following is the description of the embodiments that achieve the objectives of ablating the posterior nasal nerves (PNN). Any of the foregoing ablation devices can be used to ablate a single nerve branch or multiple nerve branches.

Therefore, it is an object of this invention to provide a method and apparatus configured for treating rhinitis by means of ablation of the function of one or more posterior nasal nerve(s) using optical image guidance.

In one aspect of this invention is a surgical probe configured for ablation of posterior nasal nerve function including a hollow elongated structure with a distal end, and a proximal end, an ablation element disposed in the vicinity of the distal end, and a means for connecting the ablation element to a source of an ablation agent at the proximal end. The probe further includes a camera disposed in the vicinity of the ablation element connected to an image display, whereby the distal region of the probe comprises a user articulated segment, and wherein the ablation element may comprise one of the following ablation element types: cryo-ablation, radiofrequency ablation, ultrasonic ablation, laser ablation, microwave ablation, or chemo-ablation.

In another aspect of this invention is a surgical probe configured for ablation of posterior nasal nerve function including a hollow elongated structure with a distal end, and a proximal end, an ablation element disposed in the vicinity of the distal end, and a means for connecting the ablation element to a source of an ablation agent at the proximal end. The probe further includes a camera disposed in the vicinity of the ablation element connected to an image display, whereby the distal region of the probe comprises a user articulated segment, and wherein the camera is associated with the user articulated segment.

In another aspect of this invention is a surgical probe configured for ablation of posterior nasal nerve function including a hollow elongated structure with a distal end, and a proximal end, an ablation element disposed in the vicinity of the distal end, and a means for connecting the ablation element to a source of an ablation agent at the proximal end. The probe further includes a camera disposed in the vicinity of the ablation element connected to an image display, whereby the distal region of the probe comprises a user articulated segment, and wherein the camera is associated with the articulated segment and is extendable and retractable by the user.

In another aspect of this invention is a surgical probe configured for ablation of posterior nasal nerve function including a hollow elongated structure with a distal end, and a proximal end, an ablation element disposed in the vicinity of the distal end, and a means for connecting the ablation element to a source of an ablation agent at the proximal end. The probe further includes a camera disposed in the vicinity of the ablation element connected to an image display, whereby the distal region of the probe comprises a user articulated segment, wherein the camera is associated with the articulated segment and configured for distal imaging.

In another aspect of this invention is a surgical probe configured for ablation of posterior nasal nerve function including a hollow elongated structure with a distal end, and a proximal end; an ablation element disposed in the vicinity of the distal end, and a means for connecting the ablation element to a source of an ablation agent at the proximal end. The probe further includes a camera disposed in the vicinity of the ablation element connected to an image display, whereby the distal region of the probe comprises a user articulated segment, wherein the camera is associated with the articulated segment and configured for distal imaging when in a retracted position, and configured for proximal imaging when in an extended position.

In another aspect of this invention is a surgical probe configured for ablation of posterior nasal nerve function including a hollow elongated structure with a distal end, and a proximal end; an ablation element disposed in the vicinity of the distal end, and a means for connecting the ablation element to a source of an ablation agent at the proximal end. The probe further includes a camera assembly disposed in the vicinity of the ablation element connected to an image display, whereby the distal region of the probe comprises a user articulated segment, and wherein the camera assembly is associated with the articulated segment and comprises a camera configured for distal imaging, and a second camera configured for proximal imaging.

Additional embodiments of this invention include a hand-piece associated with the proximal end of the elongated structure. The hand-piece may include an internal supply of an ablation agent such as cryogen used in conjunction with a cryo-ablation element disposed in the vicinity of the distal end of the elongated structure. The hand-piece may also include a means for delivering an ablation agent to the ablation element in a controllable manner, by means of a user actuated switch or valve, or some other ablation agent delivery control means. The hand-piece may include a means for articulation of the distal end, or a means for extending or retracting a camera associated with the distal end of the elongated structure. The hand-piece may further be configured for pressing the ablation element against a lateral nasal wall proximate to a posterior nasal nerve. The pressing means may include applying a torsional or lateral force to the proximal end of the elongated structure. The hand-piece may include an indication to the user of the amount of pressing force that is being applied to the lateral nasal wall. The hand-piece may be configured with an electrical connection means for connecting the camera(s) to an imaging display. Alternatively, the ablation agent source may be external to the hand-piece, whereby the hand-piece includes a means for connection to the external ablation agent source.

Additional embodiments of the invention provide the user with a means for accomplishing additional surgical steps that are associated with surgical treatment of rhinitis. The additional surgical steps may include access to a nasal sinus, dilation of the nasal cavity, or nasal sinus, or another surgical step. The means for accomplishing said additional surgical steps may include a working channel between the proximal and distal ends of the elongated structure, whereby the working channel is configured for introducing a surgical instrument into the nasal cavity or nasal sinus.

The apparatus may be configured for delivering an anesthetic agent to the tissue in the vicinity of the target Post-Nasal Nerve prior to an ablation. The delivery means may include an injection of an anesthetic into the tissue proximate to the target Post-Nasal Nerve by means of a laterally deployable needle that is connected to a syringe. An anesthetic agent may also be delivered topically from the surface of the ablation element, wherein the surface of the ablation element may include an absorbent structure such as a fibrous structure, a hydrophilic coating, or some other means for delivering a topical anesthetic agent. The anesthetic agent may include lidocaine.

An additional aspect to this invention is a method for treating rhinitis by ablation of a posterior nasal nerve under image guidance. The method includes the steps of inserting the distal end of a posterior nasal nerve surgical probe into a nasal cavity of a patient, the posterior nasal nerve surgical probe including a hollow elongated structure with a distal end, and a proximal end, an ablation element disposed in the vicinity of the distal end, a means for connecting the ablation element to a source of an ablation agent at the proximal end, and a camera disposed in the vicinity of the ablation element connected to an image display, whereby the distal region of the probe comprises a user articulated segment, and wherein the camera is associated with the articulated segment and configured for distal or proximal imaging. The method further includes identifying the ablation target region of the lateral nasal wall with the camera, articulating the distal end of the surgical probe in a lateral direction, pressing the ablation element against the target region of the lateral nasal wall using the images from the camera, and applying the ablation agent to the lateral nasal wall to effect ablation of posterior nasal nerve function.

In another aspect, a single handheld integrated therapy and imaging device is provided. The device includes a hollow elongated cannula with a proximal portion and a distal portion, a therapeutic element coupled to the distal portion of the cannula, an imaging assembly coupled to the cannula and configured to provide visualization of the therapeutic element, and an articulating region operably coupled to the imaging assembly and configured to articulate the imaging assembly relative to an axis of insertion of the cannula into a nasal cavity.

In many embodiments of the device, the articulating region may be configured to articulate the imaging device so as to translate vertically, axially, laterally, and/or rotationally to aid in visualization of the therapeutic element. In some embodiments, the articulating region may be configured to vertically, axially, laterally, and/or rotationally translate the imaging assembly by user operation. The articulating region may be configured to vertically translate the imaging assembly so as to adjust a height of the imaging assembly relative to the insertion axis of the cannula. For example, the articulating region may be configured to adjust the height of the imaging assembly relative to the insertion axis in a range from about 1 mm to about 10 mm. The articulating region may be configured to axially translate the imaging assembly so as to adjust an axial position of the imaging assembly along the insertion axis of the cannula. For example, the articulating region may be configured to adjust the axial position in a range from about 5 mm to about 60 mm. The articulating region may be configured to laterally translate the imaging assembly so as to adjust an angular position of the imaging assembly relative to a central axis of the imaging assembly. For example, the articulating region may be configured to adjust the angular position of the imaging assembly relative to the central axis of the imaging assembly in a range from about 0 degrees to about 30 degrees. As another example, the articulating region may be configured to adjust the angular position of the imaging assembly relative to the central axis of the imaging assembly in a range from about 0 degrees to about 20 degrees while maintaining a height of the imaging assembly relative to the cannula. The articulating region may be configured to rotationally translate the imaging assembly about the insertion axis of the cannula. For example, the articulating region may be configured to rotationally translate the imaging assembly in a range from about 0 degrees to about 360 degrees about the insertion axis of the cannula, about 0 degrees to about 180 degrees about the insertion axis of the cannula, and/or 45 degrees in both directions from the insertion axis of cannula.

In many embodiments of the device, the imaging assembly may include a detector and a light element. The detector and light element may be coupled to an exterior surface of the cannula via a coupler attachment. The detector and light element may be partially within a lumen of the cannula. In some embodiments, the detector and light element are co-axially arranged. In some embodiments, the detector and light element are off-axis with respect to each other.

The arrangement of the imaging assembly relative to the therapeutic element may aid in visualization and limit the invasiveness of using the device. In some embodiments of the device, the imaging assembly is coupled to the cannula so that the articulating region is configured to articulate the imaging assembly simultaneously with the therapeutic element. In some embodiments the device may include a locking mechanism configured to maintain a fixed position of the imaging assembly relative to the therapeutic element upon articulation of the imaging assembly to a desired viewing angle or position with respect to the therapeutic element. In many embodiments, it may be desirable to arrange the imaging assembly to minimize engagement with nasal tissue. Thus, the imaging assembly may be arranged proximally from the therapeutic element so as to minimize engagement with nasal tissue. As a further example, the imaging assembly may be vertically stacked relative to the cannula so as to minimize engagement with the nasal tissue.

In many embodiments of the device, the imaging assembly may be operably coupled to a display for visualization of the therapeutic element on the display. For example, the device may include an image display disposed at the proximal end of the device and operably coupled to the imaging assembly for visualization of the therapeutic element on the display. In some embodiments, the device may include a display adaptor disposed at the proximal end of the device and operably coupled to the imaging assembly. The device may further include a display removably coupled to the display adaptor for visualization of the therapeutic element on the display. The display adaptor may include a magnetic adapter for removably coupling the display to the proximal end of the device.

In many embodiments the device may be used to provide ablation therapy. The therapeutic element may include at least one of a cryo-ablation element, a radiofrequency ablation element, an ultrasonic ablation element, a laser ablation element, a microwave ablation element, and/or a chemo-ablation element. For example, the therapeutic element may be a cryo-ablation element which is expandable from a deflated configuration to an expanded configuration. It may be desirable to keep the therapeutic element from interfering with the imaging assembly. Accordingly, the device may further include a temperature control element coupled to the imaging assembly. The temperature control element may be configured to maintain the imaging assembly within an operating temperature range during activation of the therapeutic element.

It may be desirable for the device to be held and controlled by a user. In some embodiments, the device may include a handle coupled to the proximal portion. The handle may include an articulation actuator configured to actuate the articulating region.

It may be desirable to dispose the imaging assembly on an imaging cannula separate from the working cannula of the device. In order to allow for articulation, the imaging assembly may be disposed on a flexible distal portion of an imaging cannula, the imaging cannula comprising a rigid proximal portion coupled to a handle of the device. In some embodiments, the rigid proximal portion is removably coupled to the handle of the device by a handle attachment base, the handle attachment base being configured for axial translation along the nose of the handle and rotational translation about a central axis of the nose of the handle. In some embodiments, the flexible distal portion is shapeable so as to obtain a desired viewing angle or position of the imaging assembly relative to the therapeutic element.

It may be desirable for the device to allow for delivery and/or removal of material from the nasal cavity during treatment. Accordingly the device may include at least one port configured to direct a fluid or other agent into the nasal cavity and/or suction a fluid or other agent from the nasal cavity. For example, the at least one port may be disposed on the distal portion of the cannula and fluidly coupled to a lumen of the cannula. As another example, the at least one port may be disposed on the imaging assembly.

In another aspect, a single handheld integrated cryo-therapy and imaging device is provided. The device may include a hollow elongated cannula with a proximal portion and a distal portion, a cryo-ablation element coupled to the distal portion of the cannula, the cryo-ablation element being expandable from a deflated configuration to an expanded configuration, an imaging assembly coupled to the cannula and configured to provide visualization of the cryo-ablation element, and an articulating region operably coupled to the imaging assembly and configured to articulate the imaging assembly relative to an axis of insertion of the cannula into a nasal cavity.

In another aspect, a method for treating rhinitis in a tissue region within a nasal cavity is provided. The method includes inserting a distal end of an integrated therapy and imaging probe into a nasal cavity of a patient, the probe comprising a hollow elongated cannula with a proximal end and a distal end, a therapeutic element coupled to the distal end of the cannula, and an imaging assembly coupled to the cannula to provide visualization of the therapeutic element. The method further includes articulating the imaging assembly relative to an axis of insertion of the cannula into the nasal cavity until a desired viewing angle or position of the therapeutic element is obtained, and applying ablation therapy to a tissue region of a lateral nasal wall with the therapeutic element so as to treat rhinitis.

In many embodiments of the method, the imaging assembly may be articulated in various directions to obtain the desired viewing angle or position. Articulating the imaging assembly may include one of vertically translating the imaging assembly so as to adjust a height of the imaging assembly relative to the insertion axis of the cannula, axially translating the imaging assembly so as to adjust an axial position of the imaging assembly along the insertion axis of the cannula, laterally translating the imaging assembly so as to adjust an angular position of the imaging assembly relative to a central axis of the imaging assembly, or rotating the imaging assembly about the insertion axis of cannula. In some embodiments, articulating the imaging assembly includes translating the imaging assembly such that the imaging assembly is positioned distal of the therapeutic element. In some embodiments, the method further includes locking a position of the imaging assembly relative to the therapeutic element upon articulation of the imaging assembly to the desired viewing angle or position with respect to the therapeutic element.

In many embodiments, the method may further include identifying the lateral nasal wall tissue region with the imaging assembly. Identifying the lateral nasal wall tissue region with the imaging assembly may include visualizing the tissue region on a display operably coupled to the imaging assembly. For example, the display may be removably coupled to the proximal end of the probe.

In many embodiments of the method, the therapeutic element may also be articulated. For example, the method may further include articulating the therapeutic element of the probe so as to position the therapeutic element adjacent to the lateral nasal wall tissue region. This may allow for improved therapeutic effects.

It may be desirable to treat rhinitis by ablating a posterior nasal nerve. Accordingly, in many embodiments of the method, applying ablation therapy to the lateral nasal wall tissue region may include ablating at least one posterior nasal nerve within the tissue region of the lateral nasal wall with the therapeutic element.

In many embodiments, applying ablation therapy may including delivering energy to the tissue region. For example, applying ablation therapy may include delivering cryogenic energy, radio frequency energy, ultrasonic energy, light energy, microwave energy, or chemical energy to ablate the at least one posterior nasal nerve. In some embodiments, the method may include expanding the therapeutic element from a deflated configuration to an expanded configuration in contact against the lateral nasal wall tissue region. For example, expanding may include introducing a cryogenic fluid into the therapeutic element such that it is inflated from the deflated configuration into the expanded configuration against the tissue region, wherein introducing the cryogenic fluid comprises evaporating the cryogenic fluid within the therapeutic element so as to cryo-ablate the at least one posterior nasal nerve.

In order to protect the imaging assembly from the ablation energy, it may be desirable to control the temperature of the imaging assembly. For example, the imaging assembly may be maintained within an operating temperature range during ablation of the at least one posterior nasal nerve.

It may be desirable to deliver and/or remove material from the nasal cavity during treatment. Accordingly, in some embodiments, the probe includes at least one port disposed at the distal end of the probe. As an example, the port may be disposed at the distal end of the cannula and fluidly coupled to a lumen within the cannula. As another example, the port may be disposed on the imaging assembly. In some embodiments, the method further includes at least one of providing fluid or other agent into the nasal cavity using the at least one port and/or suctioning a fluid or other agent from the nasal cavity using the at least one port.

It may be desirable to dispose the imaging assembly on an imaging cannula separate from the working cannula of the device. In order to allow for articulation, the imaging assembly may be disposed on a flexible distal portion of an imaging cannula, the imaging cannula comprising a rigid proximal portion coupled to a handle of the device. In some embodiments, the rigid proximal portion is removably coupled to the handle of the device by a handle attachment base, and the method further includes at least one of axially translating the handle attachment base along the nose of the handle so as to axially translate the imaging assembly, and/or rotationally translating the handle attachment base about a central axis of the nose of the handle so as to rotationally translate the imaging assembly about the insertion axis of cannula. In some embodiments, articulating the imaging assembly comprises shaping, using a template, the flexible distal portion of the imaging lumen prior to inserting the distal end of the integrated therapy and imaging probe into the nasal cavity of the patient.

For a fuller understanding of the nature and advantages of the present invention, reference should be made to the ensuing detailed description and accompanying drawings.

DETAILED DESCRIPTION OF THE INVENTION

FIG.1is a schematic illustration of surgical ablation probe1configured for ablation of posterior nasal nerve function. As depicted in the figures, surgical ablation probe1, and its alternative embodiments are cryo-ablation probes. However, alternative ablation and therapeutic modalities, including radiofrequency, laser, microwave, ultrasonic, and chemo-ablation remain within the scope of this invention. Surgical ablation probe1comprises handle assembly2, probe shaft3, and camera assembly6. Handle assembly2comprises handle housing19, cryogen cartridge receptacle18, cryogen cartridge9, cryogen control trigger10, distal segment actuator lever8with finger grip17, and camera tube12. Probe shaft3comprises proximal end15, distal end16, cryo-ablation element4, distal articulated segment5, proximal segment21, and camera channel22. Camera assembly6comprises camera head20, camera shaft11, camera hub13, camera electrical cable14, and camera field of view7is depicted in the distal direction. Probe shaft3is between approximately 3 mm and 5 mm in diameter, and between approximately 40 mm and 100 mm long. Cryo-ablation element4is disposed in the vicinity of distal end16of probe shaft3, and is associated with articulated segment5. Distal articulated segment5is between approximately 8 mm to 20 mm long and comprises distal end16. Camera head20may include a miniature CMOS camera and light source, and is mounted on the distal end of camera shaft11. As depicted, camera field of view7is in the distal direction. Cameras with integrated light source are manufactured by Awaiba, which are described in detail at awaiba.com. Camera shaft11comprises a hollow flexible tube, which may be metallic, or a suitable plastic such polyimide. Camera shaft11houses wires that connect the camera and light source within camera housing20to an imaging console, not shown, through camera hub13, and camera cable14. Camera assembly6, and alternate embodiments will be described in further detail below. Probe shaft3also comprises camera lumen22, which is contiguous with camera tube12. Cryogen cartridge9comprises a cryogen supply which may be in liquid or gas form. Cryogen cartridge is in fluidic communication with cryo-ablation element4, through a cryogen control valve associated with cryogen trigger10. When cryogen trigger10is depressed by the user, cryogen flows to cryo-ablation element4. When cryogen trigger10is released by the user cryogen flow terminates. Exhausted cryogen from cryo-ablation element is vented to the room through the interior of probe shaft3, and a port in handle assembly2, not shown.

FIG.2Ais a side view schematic illustration of surgical probe1with distal articulated segment5in an axial configuration with camera head20retracted.FIG.2Bis a side view schematic illustration of surgical probe1with distal articulated segment5in an axial configuration, with camera head20extended. Camera assembly6comprises camera head20, camera shaft11, camera hub13, camera cable14, and an electrical connector, not shown, configured for electrical connection to an imaging display, also not shown. Camera shaft11is in a slidable relationship with camera tube12, and camera lumen22of probe shaft3. As depicted, camera head20is extended by sliding camera shaft11in the distal direction, and retraction of camera head20is accomplished by sliding camera shaft11in the proximal direction.

FIG.3Ais a side view schematic illustration of surgical probe1configured for ablation of posterior nasal nerve function with articulated segment5and cryo-ablation element4in an axial configuration, with the camera assembly6retracted into its proximal most position.FIG.3Bis a side view schematic illustration of surgical probe1with articulated segment5and cryo-ablation element in a lateral configuration with camera assembly4retracted in its proximal most position.FIG.3Cis a side view schematic illustration of surgical probe1with articulated segment5in a lateral configuration and with camera assembly4extended to its distal most position. Distal segment actuator lever8controls the position of distal articulated segment5and cryo-ablation element4. When distal segment actuator lever8is in its forward position as depicted inFIG.3A, distal articulated segment5and cryo-ablation element4is in an axial configuration as shown. When distal segment actuator lever8is pulled in the proximal direction, distal articulated segment5and cryo-ablation element are deflected into a lateral or non-axial position as shown inFIGS.3B and3C. Although illustratively referred to herein as actuator lever8, it will be understood that other mechanisms may be employed for creating a distal articulated segment as depicted here, including the use of eccentrically anchored pull wires. The combination of articulated distal segment5and associated camera assembly6provides the user with a means of endoscopically examining a nasal cavity in a distal axial and distal lateral directions, and the extension of camera assembly6as depicted allows the user to endoscopically examine nasal sinuses from the nasal cavity. Probe shaft3is configurable to be torsionally stiff to provide a rotational manipulation in addition to the lateral manipulation as described. This allows camera head20to be aimed over a spherical arc, and also provides the user the means to press cry-ablation element against the lateral nasal wall using torsional force.

FIG.4is a side view schematic illustration of surgical probe1configured for ablation of posterior nasal nerve function showing a sinuplasty balloon26mounted on camera shaft24proximal to camera head20of camera/balloon assembly23. In the embodiment depicted here, posterior nasal nerve ablation probe1is substantially identical in form and function as previously described. In the embodiment depicted in this figure, a sinuplasty functionality is added, by adding a dilatation balloon to the distal camera shaft. Sinuplasty refers to dilatation of the os of a nasal cavity to facilitate sinus drainage. In this embodiment camera/balloon assembly23comprises camera head20, which retains the form and function as previously described, camera shaft24, which includes a balloon inflation lumen, not shown, and the electrical wires connected to the CMOS camera, not shown. Camera hub25comprises a female luer fitting, which is in fluidic communication with the balloon inflation lumen, and electrical cable14and an electrical connector, not shown. Dilatation balloon26is substantially similar to dilatation balloons used in angioplasty procedure. Those skilled in the art of surgical dilatation balloon design and manufacture are familiar with the means for incorporating a dilatation balloon as depicted; therefore, no further description of the dilatation balloon is warranted. As depicted, camera head20is extended, and balloon26is inflated. During insertion of the probe into the nasal cavity, camera head20, and camera shaft24are retracted, and balloon26is deflated and resides within camera shaft lumen28. To inflate balloon26, a syringed is connected to female luer fitting27, and the syringe is used to inflate balloon27. Balloon27may be between approximately 3 to 10 mm in diameter when fully inflated, and may have a functional length between approximately 10 mm and 20 mm. The camera is used to located the os of the sinus, and camera head20is inserted through the os of the sinus, and balloon26is placed into a straddling position within the os, and then inflated to dilate the os. Balloon26is then deflated, and camera head20is withdrawn from the sinus.

FIG.5Ais a schematic illustration of the distal end of a surgical probe1configured for ablation of posterior nasal nerve function with distal articulated segment5and cryo-ablation element4in an axial configuration with camera assembly6retracted.FIG.5Bis a schematic illustration of the distal end of surgical probe1with distal articulated segment5and cryo-ablation element4in an axial configuration with camera assembly6extended. Camera objective29, and camera light source30is depicted. Also depicted are relief slits31in the wall of distal articulated segment5which are oriented on the side of lateral deflection. Relief slits31facilitate lateral deflection with a relatively short radius by removing shaft material on the inner bend radius. Camera shaft lumen22may comprise coiled wire reinforcement, not shown, in the vicinity of distal articulated segment5to prevent kinking.

FIG.6Ais a schematic illustration of the distal end of a surgical probe1configured for ablation of posterior nasal nerve function with distal articulated segment5and cryo-ablation element4in a lateral configuration at approximately 45 degrees with the camera assembly6retracted.FIG.6Bis a schematic illustration of the distal articulated segment5and cryo-ablation element4in a lateral configuration at approximately 45 degrees with camera assembly6extended.FIG.6Cis a schematic illustration of the distal end of a surgical probe1with distal articulated segment5and cryo-ablation element4in a lateral configuration at approximately 90 degrees with camera assembly6retracted.FIG.6Dis a schematic illustration of the distal end of a surgical probe1with distal articulated segment5and cryo-ablation element4in a lateral configuration at approximately 90 degrees with camera assembly6extended.FIG.6Eis a schematic illustration of the distal end of surgical probe1with distal articulated segment5and cryo-ablation element4in a lateral configuration at approximately 120 degrees with camera assembly6retracted.FIG.6Fis a schematic illustration of the distal end of a surgical probe with distal articulated segment5and cryo-ablation element4in a lateral configuration at approximately 120 degrees with camera assembly6extended.FIG.6A through6Fare illustrative of the range of motion of distal articulated segment5, cryo-ablation element4and camera assembly6.

FIG.7Ais a schematic illustration of the distal end of an alternative embodiment of a surgical probe configured for ablation of posterior nasal nerve function with distal articulated segment5in an axial configuration with back looking camera assembly33retracted.FIG.7Bis a schematic illustration of the distal end of the alternative embodiment with distal articulated segment5in an axial configuration and back looking camera assembly33in its initial stage of extension.FIG.7Cis a schematic illustration of the distal end of the alternative embodiment with distal articulated segment5in an axial configuration and back looking camera assembly33in its fully extended position.FIG.7Dis a schematic illustration of the distal end of the alternative embodiment with distal articulated segment5in an approximately 120 degree lateral configuration, and back looking camera assembly33in its fully extended position, which is the normal ablation configuration. Back looking camera assembly33provides the user with a means for confirming the correct placement of cryo-ablation element4against the lateral nasal wall proximate to a target Post Nasal Nerve. Back looking camera assembly33comprises camera head20, as previously described, curved camera shaft32, and camera hub13, and camera cable14, not shown, but previously described. Curved camera shaft32has pre-formed curve as shown. Curved camera shaft may be fabricated using a super elastic metal alloy such Nitinol® in the form of a hypotube. Those skilled in the art of super-elastic metallurgy are familiar with means for creating the pre-formed curve as shown; therefore, no further description is warranted.

FIG.8is a schematic illustration of the distal end of an alternative embodiment of a surgical probe configured for ablation of posterior nasal nerve function with distal articulated segment5in an axial configuration and dual camera assembly34comprising a distal looking camera and a proximal looking camera in its extended position, as illustrated by camera field of views7. Dual camera assembly34comprises dual camera head35, camera shaft11, camera hub13and camera cable14, not shown but previously described. Dual camera head35comprises a forward-looking CMOS camera and light source as previously described, and a second back-looking CMOS camera and light source.

FIG.9is a schematic illustration of the distal end of an alternative embodiment of a surgical probe configured for ablation of posterior nasal nerve function comprising cryo-ablation element39configured with lateral injection needle37, lateral fenestration36, and topical anesthetic delivery surface38. As depicted distal articulated segment5is in an approximately 120 degree lateral configuration, dual camera assembly34camera in its fully extended position and lateral injection needle37is deployed for anesthetic injection into the posterior nasal nerve ablation target region of the lateral nasal wall. Topical anesthetic delivery surface38is configured for applying a topical anesthetic to the lateral nasal wall proximate to the target posterior nasal nerve, in order to numb the region prior to injection of the anesthetic through lateral needle37. Lateral needle37is a hypotube, which may be fabricated from a super-elastic metal, such as Nitinol®. Lateral needle37is in fluidic communication with a proximal syringe, not shown, and is configured with a proximal needle deployment mechanism, not shown. Those skilled in the art of surgical needle probes are familiar with the means for creating a deployable needle as described; therefore no further description is warranted. Topical anesthetic delivery surface38may comprises an anesthetic carrying means such as a hydrophilic coating, or a foam or fibrous absorbable material that can absorb a topical anesthetic and deliver the anesthetic to the surface of a nasal wall by contact. Topical anesthetic delivery surface38may comprise an abrasive material configured to abrade the nasal wall to enhance the effectiveness of the topical anesthetic. The abrasive material may comprise crystalline lidocaine, or similar anesthetic material.

FIG.10is a schematic illustration of the distal end of an alternative embodiment of a surgical probe configured for ablation of posterior nasal nerve function comprising distal camera44mounted at the distal end of cryo-ablation element4, and working channel41, which is configured to introduce surgical instruments into the nasal cavity under image guidance. As depicted, balloon catheter40is inserted into working41, with balloon42, and the distal end of catheter shaft43extending beyond the distal end of working channel41. The proximal end of catheter shaft is depicted entering working channel41through working channel tube47. Distal camera44is connected to an image display, not shown by electrical cable45, and electrical connector46. As depicted, distal articulated segment5is in a 90 degree lateral configuration. The range of motion of distal articulated segment5is substantially the same as previously describe and between approximately zero and 120 degrees. Working channel41may be configured for use with catheters and probes between approximately 3 and 6 French.

As described above, a number of therapeutic modalities are within the scope of the present invention. Additional therapeutic modalities, including cryogenic ablation elements, are described in U.S. Patent Application Publication No. 2015/0164571, titled “Apparatus And Methods for Treating Rhinitis,” which application is incorporated herein by reference in its entirety.FIGS.11A-11Dshow views of one such alternate embodiment of a cryogenic ablation element, according to embodiments of the invention. In particular, the side view ofFIG.11Ashows a structure or member83which is formed into a looped and elongated structure having arcuate edges for presenting an atraumatic surface. Rather than being formed as a spring like structure, the structure83may be formed of a relatively rigid wire or member instead which maintains its configuration when pressed against a tissue surface. Structure83may form a continuous structure which defines an opening there through such as a looped or elongated and looped member which is open through the loop. The structure83may be contained entirely within the expandable structure81which may be formed to have a predefined shape which is distensible or non-distensible when inflated by the cryogen. Moreover, the expandable structure81may be formed to surround the structure83entirely without being supported by or attached to the structure83itself. Such a structure83may provide a configuration which presents a low-profile as the device is advanced into and through the nasal cavity and between the nasal turbinate tissues. Yet because of the relatively flattened shape and rigidity and integrity of the structure83, the structure83may be used to manipulate, move, or otherwise part the tissues of the nasal cavity without having to rely upon the expandable structure81. Additionally, the low-profile enables the structure83to be positioned desirably within the narrowed confines of, e.g., the cul-de-sac in proximity to the posterior nasal nerves (as shown by cul-de-sac13shown inFIG.1of previously incorporated U.S. Patent Application Publication No. 2015/0164571). When the expandable to structure81is in its deflated state, it may form a flattened shape and when inflated, the expandable structure81may inflate into a configuration which remains unsupported by or attached to the structure83. Because the structure83may be formed of a member which solid along its length, the cryogen may be introduced directly into the expandable structure81through a distal opening defined in the probe shaft145.

Alternatively, structure83may be formed of a hollow tubular member which itself is formed into the continuous or looped shape. In such an embodiment, the cryogen may be optionally introduced through the hollow tubular member and dispersed within the interior of the expandable structure81through one or more openings which may be defined along the tubular member. In yet another alternative, the structure83may be formed into a flattened shape rather than a looped shape. In this configuration, the structure may be either solid or hollow such that that cryogen may be introduced through the structure and into the interior of the expandable structure81via one or more openings defined along the structure.

The structure83may extend and remain attached to the probe shaft145, but the remainder of the structure83which extends within the expandable structure81may remain unattached or unconnected to any portion of the expandable structure81. Hence, once the expandable structure81is inflated by the cryogen, the structure83may be adjusted in position or moved via manipulating the probe shaft145relative to the interior of the expandable structure81to enable the targeted positioning and cooling of the tissue region when in contact against the outer surface of the expandable structure81. For instance, the structure83may press laterally upon a particular region of the underlying tissue to stretch or thin out the contacted tissue region to facilitate the cryogenic treatment. When the structure83is adjusted in position relative to the expandable structure81, the expandable structure81may remain in a static position against a contacted tissue region allowing for limited repositioning of the structure83within.

Alternatively in other variations, the structure83may be attached along the interior of the expandable structure81partially at particular portions of the structure83or along the entirety of the structure83. For instance, structure83may be attached, adhered, or otherwise coupled over its entirety to expandable structure81while in other variations, a distal portion of structure83may be attached, adhered, or otherwise coupled to a distal portion of the expandable structure81while in yet other variations, portions of the structure83may be attached, adhered, or otherwise coupled to the expandable structure81along its side portions. Any of these variations may be optionally utilized depending upon the desired interaction and treatment between the structure83, expandable structure81, and underlying tissue region to be treated.

In yet another alternative variation, the lumen84for introducing the cryogen into the interior of the expandable structure81may be extended past the distal end of the probe shaft such that the cryogen is released within the interior at a more distal location. As shown, the cryogen lumen84may be supported along the structure83, e.g., via a bar or member85which extends across the structure83. This particular variation may allow for the cryogen to be introduced into the distal portion of the interior of the expandable member81. Either this variation or the variation where the cryogen is released from an opening of the probe shaft may be utilized as desired.

FIG.11Bshows a side view of the embodiment ofFIG.11Aillustrating how the structure83can be formed from a relatively flattened configuration relative to the inflated expandable structure81. Because of the structural integrity of structure83and its relatively flattened profile, the structure83may provide for targeted treatment of the tissue when contacted by the device.FIG.11Cshows the side view of the inflated expandable structure81when pressed in a longitudinal direction by its distal tip against the underlying tissue surface S. The relative strength of the structure83provides for the ability to press the device against the tissue surface such that the remainder of the expandable structure81may maintain its inflated configuration to potentially insulate the other surrounding tissue regions.FIG.11Dlikewise shows the device when the structure83is pressed laterally along its side against the tissue surface S such that the structure83lies flat. The contacted tissue region may be treated while the remainder of the surrounding tissue is potentially insulated by the expanded structure81.

While the treatment end effector is designed for application along the tissue region defined by the cul-de-sac, the same end effector may be used in other regions of the nasal cavity as well. For instance, once the ablation is performed along the cul-de-sac, the end effector may then be moved to an adjacent tissue region, e.g., region immediately inferior to the cul-de-sac, and ablation treatment may be effected again. Additionally and/or alternatively, the end effector may also be used to further treat additional tissue regions, e.g., posterior aspect of the superior, middle, and/or inferior turbinates (any one, two, or all three regions). In either case, once the cul-de-sac has been ablated, the end effector may remain in place until the tissue region has thawed partially or completely before the end effector is moved to the adjacent tissue region for further treatment.

Once the treatment is completed, or during treatment itself, the tissue region may be assessed utilizing any number of mechanisms. For instance, the tissue region may be visually assessed utilizing an imager during and/or after ablation.

As described herein, the device may be utilized with a temperature sensor, e.g., thermistor, thermocouple, etc., which may be mounted along the shaft, within or along the expandable structure81, along the structure83, etc., to monitor the temperature not only of the cryogen but also a temperature of the tissue region as well under treatment.

Additionally and/or alternatively, the expandable structure81may also be vibrated while maintaining the structure83against the interior of the expandable structure81and the tissue region utilizing any number of vibrational actuators which may be mounted anywhere along the device as appropriate. The vibrations may be applied directly against the tissue region or, e.g., through a layer of gel to facilitate the vibrational contact with the tissue.

Additionally and/or alternatively, other biocompatible agents may be used in combination with the cryogenic treatment. For instance, in one variation, an anesthetic may be applied to the tissue region to be treated prior to or during the cryogenic treatment. This and other alternative features described may be utilized not only with the variation shown and described inFIGS.11A and11Bbut with any other embodiments described herein and in previously incorporated U.S. Patent Application Publication No. 2015/0164571.

FIG.12Ais a perspective view of an integrated therapy and imaging device1200with a display1208, andFIG.12Bis a perspective view of the distal end of the integrated therapy and imaging device ofFIG.12A, according to embodiments of the invention. Device1200may operate similarly to probe1described above, except that it may incorporate a display1208for ease of viewing during insertion of the distal end of device1200into a patient's nasal cavity.

With reference toFIG.12A, it can be seen that handle1202includes an actuator1220that may cause cryogen contained in the cryogen container (not shown) housed in handle1202to flow through cannula1216to cryo-ablation element1218. As can be seen inFIG.12B, cryo-ablation element1218may be an inflatable structure with an internal structure1222, which may be similar to expandable structure81and structure83described above with respect toFIGS.11A-11D. Cannula1216extends from an opening in housing1210of device1200.

Device1200also includes an imaging cannula1212that extends from the opening in housing1210. Imaging cannula1212may have an imaging assembly1214disposed at the distal end thereof. Imaging assembly1214may include an imaging sensor (not shown) and light element (not shown) configured to provide visualization of cryo-ablation element1218. For example, the imaging sensor of imaging assembly1214may be a CMOS imaging sensor, a CCD imaging sensor, or any other suitable sensor or sensors for detecting image information and converting that information into signals to be displayed on display1208. Alternatively, imaging assembly may utilize one or more protected optic fibers that run within a lumen inside imaging cannula1212to a camera mount disposed on device1200, at which point a CMOS or CCD imaging sensor may be coupled to the fibers. Light element of imaging assembly1214may include one or more LEDs disposed at the distal end of imaging cannula1212, although other suitable light generating elements may also be used. Alternatively, one or more optic fibers that run within imaging cannula1212may be used to channel light to the working area around cryo-ablation element1218. Such optic fibers may be coupled to one or more LEDs or other light generating elements integrated into handle1202, or may be terminated at a standard ACMI adapter port to enable connection to an external light source as desired.

In order to be used in the nasal cavity, it may be preferable for the imaging assembly1214to have a field of view of at least 75 degrees and a viewing distance of at least 5 mm. Moreover, it may be preferable for imaging assembly1214to have an effective diameter of less than 2.5 mm.

FIG.12Cshows an embodiment of the device1200with a malleable imaging cannula1212C. Cannula1212C may be constructed of malleable materials such as aluminum, copper, annealed steel, or some polymers. Cannula1212C can be shaped in situ to a shape that is conducive to the desired field of view of the ablation element1218. An initial shape is shown as1275A, and an exemplary resulting shape is shown as1275B. Once cannula1212C takes the desired shape a flexible or elastic imaging component can be inserted into the cannula1212C and then pushed forward until it exits the distal end of the cannula and naturally be in the proper location as defined by cannula1212C apriori.FIG.12Dshows imaging assembly1204D inserted through malleable imaging cannula1212C after cannula1212C has been formed into shape1275B described above. Imaging assembly1204D may be constructed of elastic material such as a spring coil or nitinol or an elastomer like silicone or polyurethane. The elastomeric property of this variation of assembly1404D allows it to be easily inserted into the cannula1212C described with reference toFIG.12Cand push out the distal end of malleable cannula1212C.

FIG.12Eshows another embodiment of device1200with a shape memory image assembly1204E. Shape memory image assembly1204E is made out of a material with shape memory such as spring steel, nitinol, shape memory polymers, or other suitable shape memory materials. Shape memory image assembly1204E may have an original shape that allows a desired viewing angle and/or position relative to therapeutic element1218. Shape memory image assembly1204E may be inserted into cannula1212E and be elastic enough to take a straight shape while moving through cannula1212E, and take its original shape as it exits cannula1212E. The original shape may be any suitable shape, and may have a curved, zigzag, or dogleg shape as needed.

FIGS.13A and13Bshow simplified schematics of alternative arrangements of imaging sensors1302and light elements1304, according to embodiments of the invention. It will be understood that these arrangements of imaging sensors1302and1304can be employed in imaging assembly1214or any other imaging assembly described herein.FIG.13Ashows a co-axial arrangement of imaging sensor1302A and light element1304A. For example, light element1304A may be a ring of LEDs surrounding imaging sensor1302A.FIG.13Bshows an off-axis arrangement, with light element1304B directing light off-axis of imaging sensor1302B.

Device1200may include an articulation actuator that is embedded or attached to device handle1202, which may cause either or both of imaging assembly1214and/or cryoablation element1218to articulate in the manner described herein. For example, the actuator may be configured to cause an articulating region of cannula1216or imaging lumen1212to articulate as described with respect toFIGS.1-9and14-21herein.

As described above, device1200may include a display1208operably coupled to imaging assembly1214. Display1208may be a smart phone, tablet, or other stand-alone display that can output video with a desired resolution. Display1208may be integrated with device1200, or, alternatively, may be removably coupled from device1200. For example, display1208may be removably coupled to display adapter1206by any suitable connection allowing attachment and detachment as needed by the user. For example, display adapter1206may include one or more magnetic elements that attract complementary magnetic elements on display1208to keep display1208in place as shown, but which allow a user to detach display1208as needed. Display adapter1206may also include the requisite electrical connections which connect display1208to imaging assembly1204and any components thereof. Thus, when connected to display adapter1206, display1208can receive signals from imaging assembly1204and the components thereof to display cryo-ablation element1218and the surrounding areas during use of device1200. The placement of display1208on device1200as shown may be preferable to using an external display at a remote location, since display1208may more easily fall in the line of sight of the healthcare provider during use of device1200. This way, the healthcare provider will not need to look away from the patient when using device1200.

FIGS.14A-14Eshow views of a distal end of an integrated therapy and imaging device1400, according to embodiments of the invention. Device1400may be used to provide therapy in the nasal cavity as described above. For example, device1400may be used to deliver energy to tissue in the nasal cavity to ablate a posterior nasal nerve to treat rhinitis. As can be seen inFIG.14A, device1400may have a therapeutic element1410for delivering the energy to tissue via working cannula1408. For example, therapeutic element1410may be a cryo-ablation element as described previously.

In order to provide visualization of therapeutic element1410during positioning and treatment, an imaging attachment1401may be provided. Imaging attachment1401may include an imaging cannula1402with an imaging assembly1404disposed at the distal end of imaging cannula1402. Imaging cannula1402and imaging assembly1404may generally be similar to imaging cannula1212and imaging assembly1214described above with respect toFIGS.12A-12B, except that rather than extending from within a housing in device1400, they are externally coupled to the working cannula1408via one or more couplers1406. Couplers1406may be a C-shaped clip that keep imaging attachment1401coupled to working cannula1408, but allow particular movement of imaging attachment1401and imaging assembly1404relative to therapeutic element1410. For example couplers1406may be friction fittings that allow relative movement between working cannula1408and imaging cannula1402, but only upon relative friction above a certain threshold. For example, the threshold relative friction may be ½ to 1 pound of force. This will allow the imaging cannula1402to remain coupled to working cannula1408during normal operation of device1400, but still allow relative translation when desired upon minimal application of force by the user. Couplers1406may be made of polyurethane, latex, silicone, or other similar materials.

Although not shown inFIG.14A, device1400may have a display disposed at the proximal end of the device that is operably coupled to the imaging assembly1404for visualization of the therapeutic element1410. Alternatively, device1400may have a display adaptor disposed at the proximal end that is operably coupled to the imaging assembly1404via wiring or optical fibers disposed in imaging cannula1402. The display adaptor may be configured to connect to any suitable external display for providing visualization of the images detected by imaging assembly1404.

In order to view the therapeutic element1410from an optimal viewing angle or position, the imaging attachment1401may include an articulating region1403that is operably coupled to the imaging assembly1404and configured to articulate the imaging assembly1404. As shown inFIG.14B, imaging assembly1404may be configured to translate axially in the X direction to adjust the distance from therapeutic element1410. Axial translation in this direction may range from about 5 mm to about 60 mm. Imaging assembly1404may also be configured to translate vertically in the Y direction to adjust the height of imaging assembly1404relative to working cannula1408. Vertical translation in this direction may range from about 1 mm to about 10 mm. Imaging assembly1404may also be configured to laterally translate to adjust an angle α with respect to a central axis1412of imaging assembly. This may allow imaging assembly to obtain a desired viewing angle of therapeutic element1410. This lateral translation may range from about 0 degrees to about 30 degrees. Additionally, imaging assembly1404may be configured to rotationally translate in the “R” direction about the insertion axis1414of the working cannula1408. The range of rotation may be the entire 360 degrees about the insertion axis1414, 0 to 180 degrees about the insertion axis1414, or 45 degrees rotation about the insertion axis1414in either direction (from the initial position shown inFIG.14A). This may allow imaging assembly1404to view therapeutic element1410from different vantage points as may be needed during use of device1400. These degrees of freedom will also allow the imaging assembly1404to be positioned in a different location during insertion than during delivery of a therapeutic agent by therapeutic element1410.

Because therapeutic elements such as cryo-ablation elements (or other ablation elements) may create extreme temperatures, imaging assembly may be coupled to a temperature control element1425(shown schematically inFIG.14A). Temperature control element1425may include temperature sensors to detect the temperature of the imaging assembly1404and heating or cooling elements that can be controlled in response to the detected temperatures to maintain the imaging assembly within an operating temperature range during activation of therapeutic element1410. For example, if device1400uses a cryoablation element, a heating element such as a heating coil may be provided to maintain imaging assembly within a suitable operating temperature. In some embodiments, the light element of imaging assembly1404may act as a heating element to keep imaging assembly within a suitable operating temperature. For example, one or more LEDs used as lighting elements may also be used has heating elements to keep imaging assembly1404(including image sensor) within a suitable operating temperature.

With reference back toFIG.14A, it can be seen that imaging assembly1404may be in a default position prior to any articulation. InFIG.14B, imaging assembly1404may be in an elevated position after vertical translation thereof. InFIG.14C, imaging assembly1404may be both elevated vertically and angled laterally to point at therapeutic element1410from above. And, inFIG.14D, imaging assembly1404is rotationally translated from the position inFIG.14B. Although not shown in detail inFIGS.14A-14D, in some embodiments, articulation of the imaging assembly1404may be effected using pullwires, slides, and/or dials that terminate at the proximal end of the device, where the user can manipulate the imaging assembly1404with their hand. For example, pullwires coupled to imaging assembly1404may extend through imaging cannula1402and may be tightened or loosened by the user using levers or other articulation actuators so as to cause articulating region1403to axially, vertically, laterally, and rotationally translate imaging assembly1404as desired. In some embodiments, axial and rotational translation may be directly caused manually by the user, while lateral and vertical translation may be actuated with levers coupled to guide wires.

As shown inFIGS.14A-14D, imaging assembly1404may be disposed proximally of therapeutic element1410so as to minimize engagement with nasal tissue when the distal end of device1400is inserted into the nasal cavity. Specifically, imaging assembly1404may be dimensioned to fit within the profile dimensions of therapeutic element1410so that therapeutic element1410effectively protects imaging assembly from engagement with nasal tissue. Since therapeutic element1410has a predominantly vertical profile, it may be desirable to vertically stack imaging assembly1404and its components within this profile. Additionally, in some embodiments it may be desirable to limit the articulation of imaging assembly1404to remain within the profile of therapeutic element1410.

FIG.14Eshows a schematic illustration of one or more flushing and/or vacuum ports1430disposed on imaging assembly1404and/or working cannula1408, according to embodiments of the invention. As can be seen inFIG.14E, ports1430for flushing and/or vacuum may either embedded on working cannula1408or embedded on the body of the imaging assembly1404. Ports1430may be fluidly coupled to channels within working cannula1408and/or imaging cannula1402to allow fluid to pass through, exit at the distal end of the working cannula1408, and/or be sucked back outside the body. Although only shown schematically inFIG.14E, flush ports1430may be designed to direct fluid at the imaging assembly1404and vacuum ports may be positioned about 180 degrees around the imaging assembly from the flush ports1430to catch fluid passing towards the imaging assembly1404. The flush port inner lumen diameter may range from about 0.005 inches to 0.025 inches. The vacuum port inner lumen diameter may range from 0.005 inches to 0.025 inches and can be contoured to the outer edge of the imaging element.

Although not shown inFIGS.14A-14E, it will be understood that multiple couplers1406may be used so that there are multiple attachment points between imaging attachment1401and working cannula1408. In some embodiments, couplers1406may provide attachment points on articulating region1403so as to allow articulation of therapeutic element1410together with or independently of imaging assembly1404.

A number of benefits of integrating an imaging attachment (such as imaging attachment1401) with the aforementioned features can be appreciated. First, the integration of the imaging attachment with the therapeutic element may allow a user such as a healthcare provider to perform a therapeutic procedure with visualization using a single hand. This may decrease the time, cost, and labor involved in a given procedure, and may decrease the degree of difficulty for a given procedure. Second, the integration of the imaging attachment with the therapeutic procedure will improve the visualization of such a procedure, since it will ensure that the imaging will be able to reach sufficiently posterior to obtain detailed visualization of the target region. This is in contrast with rigid or flexible endoscopes which often do not allow imaging sufficiently close to the relevant working tool. Because the imaging attachment is coupled to the working device and can be manipulated to and then fixed at a desired position relative to the therapeutic element, it will assuredly reach posterior enough to provide sufficiently detailed imaging of the therapeutic element and target region.

FIG.15shows a perspective view of an articulating imaging attachment1500, according to embodiments of the invention. Articulating imaging attachment1500may include a handle attachment base1516which may connect imaging attachment1500to a handle of a therapeutic device as will be described with reference toFIGS.16A-B,17A-B, and18A-B. Articulating imaging attachment1500may have an imaging cannula1502similar to imaging cannula1402described above, with an imaging assembly1504, similar to imaging assembly1404described above, disposed at the distal end. Imaging cannula1402may be coupled to a working cannula of a device via one or more couplers1506similar to couplers1406described above. Articulating imaging attachment1500may also have articulating region1503similar to articulating region1403.

In order to actuate the articulation of imaging assembly1504, articulating imaging attachment1500may have a flexing lever1518that translates back and forth as shown by arrows1517. Flexing lever1518may be coupled to pull wires housed in imaging cannula1502and coupled to imaging assembly1504, so that when flexing lever is initially pulled in the proximal direction, the pull wire attached to the imaging assembly1504tightens and causes imaging assembly1504to vertically translate. As flexing lever1518reaches the last portion of travel (e.g. the last 2-3 mm), imaging assembly1504may stop vertically translating and may begin to laterally translate to angle image assembly1504relative to its central axis. The angle may range from about 0 to about 20 degrees from the central axis of imaging assembly1504without losing the vertical translation, similar to the lateral translation angle α described above with respect to imaging assembly1404. Thus, it can be seen that flexing lever1518may allow for vertical and lateral translation of imaging assembly1504. In order to lock imaging assembly1504at a desired viewing angle or position, a locking mechanism1520(shown schematically inFIG.15) may be provided. Locking mechanism1520may be any suitable mechanism that keeps flexing lever1518in a desired position. For example, as the user translates flexing lever1518to a desired position, locking mechanism1520may automatically or upon actuation of a button or other mechanism keep flexing lever1518in the desired position so that the position and/or viewing angle of imaging assembly1504is fixed relative to the therapeutic element of the device that imaging attachment1500is attached to.

Imaging attachment1500may also allow axial and rotational translation of imaging assembly1504as described above with respect to imaging assembly1404. In particular, handle attachment base1516may snap onto the handle of a therapeutic device1600as shown inFIGS.16A-16B,17A-17B, and18A-18B. The connection between handle attachment base1516and device1600may allow base1516to translate axially in the X direction (shown inFIG.16A) and rotationally in the R direction around the distal nose of the handle of device1600(shown inFIG.16A) similar to the axial and rotational translation described with respect to imaging assembly1404above. In order to ensure one to one rotation between handle attachment base1516and imaging assembly1504, the portion of imaging cannula1502extending from attachment base1516to coupler1506may be rigid. This way, the axial and rotational translation may be manually done by a user by axially translating and rotating attachment base1516. The range of axial and rotational translation may be the same as described above with respect to imaging assembly1404.

Vertical and lateral translation of imaging assembly1504will now be described with reference toFIGS.16A-16B,17A-17B, and18A-18B.FIGS.16A and16Bshow views of a device1600with integrated articulating imaging attachment1500in a non-articulated position, according to embodiments of the invention. As can be seen inFIG.16A, when imaging assembly1504is not articulated, flexing lever1518is in its most distal position. Upon pulling of flexing lever1518proximally (or in direction1700shown inFIG.17A), imaging assembly1504may begin to articulate vertically.

FIGS.17A and17Bshow views of device1600with articulating imaging attachment1500in an elevated position, according to embodiments of the invention. As can be seen inFIGS.17A-17B, flexing lever1518is translated proximally in direction1700with respect to the position of flexing lever1518inFIGS.16A-16B, and this translation has caused articulating region1503to bend, which has vertically translated imaging assembly1504at a height above working cannula1608.

As described above, further translation of flexing lever1518in direction1700may cause lateral articulation of imaging assembly1504at an angle with respect to the central axis of imaging assembly1504without losing the vertical translation previously obtained.FIGS.18A and18Bshow views of device1600with articulating imaging attachment1500in an elevated and downwardly angled position, according to embodiments of the invention. As can be seen inFIGS.17A-17B, flexing lever1518is translated at the most proximal location in direction1700with respect to the position of flexing lever1518inFIGS.17A-17B, and this translation has caused articulating region1503to further bend, which has angled imaging assembly1504downwardly towards therapeutic element1610.

FIG.19shows a perspective view of an imaging attachment1900with a malleable distal portion1903, according to embodiments of the invention. Imaging attachment1900may be similar to imaging attachment1500, except that rather than a lever-actuated articulating region, imaging attachment has a malleable distal portion1903on which imaging assembly1904is disposed, and a proximal rigid portion1905coupled to handle attachment base1916. Rather than actuating articulation to adjust the position and/or viewing angle of imaging assembly1904as described in the embodiments above, the malleability of distal portion1903may allow this portion to be shaped (such as shape1903A) by a user for a desired position and/or viewing angle of imaging assembly1904. In some embodiments, proximal rigid portion1905may be made of a rigid steel, brass, aluminum, copper tubing, or rigid plastic, and malleable distal portion1903may be made of the same material as rigid portion1905, but may be fully annealed, selectively annealed, thinned, or otherwise treated so as to be sufficiently malleable to be shaped by a user prior to use. Alternatively, the malleable distal portion1903may be made of a composite of polymer and metal. Malleable distal portion1903may be sufficiently malleable so as to be shaped by hand by a user, with or without application of additional energy such as heat. Once shaped as desired, malleable distal portion1903may remain semi-flexible, but generally maintain its shape in operation.

Because it may be desirable to have a particular shape of the malleable distal portion1903for a given procedure, a template may be used to shape the malleable distal portion1903. The template may allow consistency across a number of healthcare providers or other users, while still allowing the users to provide a choice in the exact shape of the malleable distal portion1903so as to adjust the viewing angle and position of imaging assembly1904relative to a therapeutic element.FIGS.20A and20Bshow an exemplary template2000used to shape the malleable distal portion1903of imaging attachment1900, according to embodiments of the invention. Template2000may have one or more shaping channels2003in which the malleable distal portion1903may be placed for shaping. Shaping channels2003may be designed to obtain a desired default shape for malleable portion1903, which shape may provide an optimal position and/or angle with respect to a therapeutic element of a device. The user may then press the distal portion to follow the contours of shaping channel2003to obtain the desired shape for a given procedure. It will be understood that different templates may be generated and used for different procedures and/or different patients. For example, a given procedure may require a different shape to obtain an optimal position or angle, and thus a different template or a different shaping channel within the same template (as shown inFIG.20) may be used to shape the malleable portion1903. A single template such as template2000may have multiple shaping channels to account for variations in the anatomy while still providing a uniform shape across healthcare providers.

FIG.21Ashows a perspective view of a device2100with imaging attachment1900, according to embodiments of the invention. Device2100may be a therapeutic device with a working cannula2108and therapeutic element2110disposed at the distal end, similar to the devices described above. As with imaging attachment1500, handle attachment base1916of imaging attachment1900may snap onto the handle of device2100, and the connection between handle attachment base1916and device2100may allow base1916to translate axially in the X direction (shown inFIG.21A) and rotationally in the R direction around the distal nose of the handle of device2100(shown inFIG.21A). The rigidity of portion1905will ensure one to one rotation between handle attachment base1916and imaging assembly1904. This way, the axial and rotational translation may be manually done by a user by axially translating and rotating attachment base1916. The range of axial and rotational translation may be the same as described above with respect to imaging assembly1404and imaging assembly1504. Imaging attachment may also be coupled to cannula2108using a coupler1906similar to couplers described above.FIGS.21B and21Cshow perspective views of device2100with imaging attachment1900at various rotated positions relative toFIG.21A, according to embodiments of the invention. As can be seen inFIGS.21A-21C, imaging assembly1904remains in the same position and viewing angle as originally shaped, and merely rotates in the R direction to various positions about the axis of insertion of cannula2108.

The applications of the disclosed invention discussed above are not limited to certain treatments or regions of the body, but may include any number of other treatments and areas of the body. Modifications of the above-described methods and devices for carrying out the invention, and variations of aspects of the invention that are obvious to those of skill in the arts are intended to be within the scope of this disclosure. Moreover, various combinations of aspects between examples are also contemplated and are considered to be within the scope of this disclosure as well.