Devices for therapeutic sinus procedures

Abstract

Providing a device for therapeutic sinus procedures. The present invention generally relates to systems and methods for targeting specific tissue(s) of interest within the sinus region of a patient for the treatment of rhinosinusitis conditions. The devices of the present invention include an end effector including one or more flexible printed circuit board (PCB) members for delivering energy to one or more target sites within the patient's sinus while minimizing or avoiding collateral damage to surrounding or adjacent non-target tissue, such as blood vessels, bone, and non-target nerve tissue.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Application Nos. 63 / 072,352, filed August 31, 2020, 63 / 184,373, filed May 5, 2021, 63 / 184,377, filed May 5, 2021, and 63 / 184,383, filed May 5, 2021, the contents of each of which are incorporated herein by reference in their entirety.

[0002] The present invention relates generally to systems for treating medical conditions, and more particularly to devices for the treatment of rhinosinusitis conditions. [Background technology]

[0003] Rhinitis is an inflammatory disease of the nose that is reported to affect up to 40% of the population. It is the fifth most common chronic disease in the United States. The most common and impactful symptoms of rhinitis are nasal congestion and rhinorrhea. Allergic rhinitis accounts for up to 65% of all rhinitis cases. Allergic rhinitis is an immune response to exposure to allergens such as airborne plant pollen, pet dander, or dust. Non-allergic rhinitis is an occurrence of the common rhinitis symptoms of nasal congestion and rhinorrhea. Because non-allergic rhinitis is not an immune response, its symptoms are usually not seasonal and are often more persistent. Symptoms of rhinitis include runny nose, sneezing, sinus itching, and nasal congestion.

[0004] Current treatment devices generally provide therapeutic treatments using a variety of modalities, such as cryotherapy cooling, ultrasound energy (e.g., high intensity focused ultrasound (“HIFU”) energy), microwave energy (e.g., via microwave antennas), direct heating, high and / or low power laser energy, mechanical vibration, and / or optical power. Delivery of such therapeutic treatments is provided via one or more discrete elements (e.g., electrodes, transducers, etc.) provided on some form of end effector. Summary of the Invention [Means for solving the problem]

[0005] The present invention is a new and unique end effector and various manufacturing techniques that utilize the benefits of flexible printed circuit boards (PCBs) to provide an improved device for the treatment of rhinosinusitis conditions. Specifically, the end effector includes one or more retractable and expandable sections, each comprising a framework of support elements having elastic properties. Each retractable and expandable section further includes one or more flexible printed circuit board (PCB) members provided thereon. The flexible PCB members are comprised of a flexible material capable of moving (e.g., bending, twisting, folding, etc.) between various positions in response to movement of the underlying retractable and expandable sections attached thereto. Each flexible PCB member further includes one or more energy delivery elements (e.g., electrodes) provided thereon and configured to deliver energy to tissue associated with one or more target sites within the sinus. Once delivered within the sinus, the one or more segments expand to a specific shape and / or size that corresponds to the anatomical structure within the sinus and is associated with the target site, and can receive delivery of therapeutic energy for treatment of the condition (i.e., rhinosinusitis or the like). Thus, once deployed, the flexible PCBs of the first and second segments contact and conform to the shape of the one or more anatomical structures, including to complement the shape of the one or more anatomical structures, thereby precisely positioning the electrodes for focused application of energy to targeted tissue at the one or more target sites.

[0006] The present invention utilizes many of the benefits of flexible PCBs as well as certain manufacturing techniques to provide an end effector that is highly conformable to anatomical variations within the sinuses so that an operator can perform precise, minimally invasive, and localized application of energy to one or more target sites within a patient's sinuses, thereby treating sinus conditions.

[0007] In particular, the underlying design of the end effector is unique. In a preferred embodiment, the end effector is multi-sectioned and includes a proximal section and a distal section. The proximal and distal sections are constructed from a single, integral workpiece having elastic properties. More specifically, a single piece of shape-memory material, such as Nitinol, may be used to construct one or more portions of the proximal section and the distal section as a whole. For example, in one embodiment, the proximal section is comprised of a pair of interlocking members, while the distal section is comprised of a single member. The pair of interlocking members of the proximal section includes a first member providing a first set of support elements and a second member providing a second set of support elements. Thus, each of the first and second members may be constructed from a single workpiece and subsequently interlocked within one another to form the proximal section, while the distal section comprises a single component (as opposed to an interlocking component) and is thus formed from a single workpiece.

[0008] A single workpiece may initially be in the form of a tube or flat plate and laser cut to form the desired framework of the support elements for the proximal and distal sections. In addition to reducing time, cost, and complexity, the use of laser machining allows manufacturers a greater amount of design freedom, which in turn leads to more tailored geometries and mechanical properties for a given section of the end effector. For example, laser machining allows for greater control of the mechanical properties of the support elements, including tailoring the stiffness of a specific one or a given group of support elements for a given section, thereby enabling tailored tissue contact profiles when a given section is in the expanded, deployed configuration. Furthermore, utilizing raw material workpieces in the form of tubes or flat plates results in support elements with relatively flat surfaces onto which corresponding flexible PCB members are affixed, thereby improving adhesion of the PCB members to tissue within the sinus.

[0009] Furthermore, the use of flexible PCB members provides a greater amount of usable surface area than would otherwise be available with existing end effectors. The increased surface area allows a greater number of energy delivery elements to be introduced and utilized in a given procedure, further expanding the number of possible patterns of such energy delivery elements. As a result, the contact surface is substantially increased, thereby enabling the end effector of the present invention to deliver treatment to areas within the sinuses that may previously have been inaccessible or untreatable with current treatment devices, or that previously required the surgeon to reposition a given device to reach such areas. The use of flexible PCB members also reduces the overall complexity associated with manufacturing the end effector of the present invention. In particular, any given flexible PCB member (including the overall PCB assembly, including multiple PCB members) is constructed separately from the end effector, which includes building the overall electrode design and installation on the given PCB member. Once the PCB assembly is completed, the PCB members are then attached to individual portions of a given section of the end effector as a separate manufacturing step, thereby reducing the complexity otherwise associated with placing electrodes directly on the end effector, which is common practice.

[0010] The present invention provides improved manufacturing techniques for joining PCB members to support elements of a given proximal or distal section. In particular, the present invention contemplates the use of bonding, thermal, and mechanical processes to join PCB members to individual support elements, which may include one or more of adhesive, mechanical, laminating, polymer reflow, induction heating, spot welding, and laser welding processes. For example, in one embodiment, attaching PCB members to individual support elements includes a reflow process in which a flexible PCB member is positioned against the individual support element, one or more polymer layers are then disposed around the flexible PCB member, and heat is then applied, resulting in the one or more polymer layers surrounding the flexible PCB member and subsequently affixing the flexible PCB member to the underlying support element of the end effector section. In another embodiment, a polymer sleeve may be affixed to the support element, thereby providing a substrate onto which a flexible PCB member may be positioned and subsequently attached. It should be noted that the processes of adhering the polymer sleeve and bonding the flexible PCB member to the support element may occur simultaneously through the application of pressure and heat.

[0011] In some embodiments, one or more of the support elements of the lower proximal and distal sections of the end effector may further include fastening points to facilitate attachment and alignment of the polymer sleeve and / or flexible PCB member thereto. For example, one or more of the support elements may include recesses, holes, notches, grooves, etchings, or the like, to increase surface area and receive a pool of adhesive or molten polymer to mechanically secure the sleeve and / or PCB member in place, ensure alignment, and simplify assembly.

[0012] Thus, the end effector of the present invention addresses shortcomings of current treatment devices. In particular, the present invention recognizes that current treatment devices may have limitations with regard to the delivery of therapeutic energy to a tissue of interest because energy delivery may be limited by the architecture of a given end effector. More specifically, many current devices include end effectors with several energy delivery elements discretely located along a portion thereof, which results in the surgeon having to reposition the end effector and deliver energy multiple times to a single target site to ensure the tissue of interest receives proper treatment. Thus, such devices may result in incomplete treatment of the targeted tissue and / or collateral damage to surrounding tissue, organs, bone, or the like.

[0013] One aspect of the present invention provides a device for treating a condition within a paranasal sinus. The device includes an end effector sized for insertion into the paranasal sinus, the end effector including at least one section that is a unitary, single piece of material including a plurality of individual struts. The device further includes a flexible printed circuit board (PCB) member attached to at least one of the struts. The flexible PCB member is configured to deliver energy to one or more target sites within the paranasal sinus.

[0014] In some embodiments, the plurality of individual struts are transformable between a retracted configuration and a deployed configuration. In some embodiments, at least some of the plurality of individual struts are in a coaxial configuration relative to the longitudinal axis of the device when in the deployed configuration. In other embodiments, at least some of the plurality of individual struts are in an annular configuration relative to the longitudinal axis of the device when in the deployed configuration. In some embodiments, at least some of the plurality of individual struts comprise a free distal end. For example, at least one section comprises a distal section, and each of the plurality of individual struts of the distal section comprises a free distal end. In some embodiments, at least some of the plurality of individual struts comprise a connector connecting different ones of the struts.

[0015] The end effector is multi-sectioned and includes at least two sections, including a distal section and a proximal section. In some embodiments, the distal section generally includes a proximal end in the form of a collar or the like shaped and / or dimensioned to be received by a portion of the proximal section. In particular, the collar of the distal section may fit within a corresponding collar of the proximal section such that the proximal and distal sections are coaxially aligned and share a common longitudinal axis.

[0016] In some embodiments, the proximal section comprises at least one pair of struts, each of the struts having a first end and a second end that are each connected to a portion of the proximal section. In other words, the pair of struts does not include a free, free-standing end (i.e., an end that is not connected to anything). In some embodiments, the distal section comprises struts that are deployable into a coaxial configuration relative to the longitudinal axis of the device.

[0017] In some embodiments, at least some of the individual struts include one or more articulation sites that improve the flexibility of the struts. For example, one or more of the articulation sites include an area of ​​reduced material. The area of ​​reduced material may form, for example, an S-shaped configuration.

[0018] In some embodiments, a portion of the plurality of individual struts are arranged around a periphery of the distal end of the end effector, and in such embodiments, at least one of the plurality of individual struts comprises a stiffness different from a stiffness of a second strut.

[0019] In some embodiments, the plurality of individual struts comprises at least two substantially flat faces that face each other.

[0020] In some embodiments, each of the plurality of struts includes a corresponding flexible PCB member. However, it should be noted that in some embodiments, some of the plurality of struts may lack a corresponding flexible PCB member.

[0021] In some embodiments, the device further comprises a soft polymer disposed between the flexible PCB member and at least one of the plurality of individual struts, hi other embodiments, the soft polymer may be disposed across the flexible PCB member and at least one of the plurality of individual struts.

[0022] Another aspect of the invention provides a method of constructing a device for treating an intra-sinus condition, the method including providing an end effector dimensioned to be deployed at least partially inside a patient's sinus, and attaching a flexible printed circuit board (PCB) member to the end effector, the flexible PCB configured to deliver energy to a target site within the sinus.

[0023] In some embodiments, the attaching step involves a thermal process. The thermal process may comprise one of a reflow process, induction heating, spot welding, or laser welding. The reflow process may include, for example, polymer reflow.

[0024] In some embodiments, the thermal process includes positioning a flexible PCB member on the effector, disposing one or more polymer layers around the flexible PCB member, and applying at least heat.

[0025] In another embodiment, in order to mount the flexible PCB member, a polymer sleeve is adhered to a portion of the end effector via polymer modification, thereby providing a substrate onto which the flexible PCB member is mounted.

[0026] In some embodiments, a portion of the end effector includes one or more fastening points to facilitate attachment of the flexible PCB to the end effector. The one or more fastening points include recesses, holes, notches, or grooves etched into the end effector. The one or more fastening points may be located on a distal portion of the end effector.

[0027] In some embodiments, at least a portion of the flexible PCB member is attached to the end effector by adhesive, which is applied to one or more fixation points located on the end effector prior to attachment to the flexible PCB member.

[0028] In some embodiments, the end effector may include one or more deployable struts to which a flexible PCB member is attached. In some embodiments, at least some of the deployable struts include free distal ends. The deployable struts may include opposing surfaces, and the flexible member is attached to the opposing surfaces. In some embodiments, the flexible PCB member is machined from a single sheet of flexible PCB material.

[0029] Another aspect of the invention provides a method of constructing a device for treating intra-sinus conditions, the method including providing a single piece of metal and cutting the single piece of metal to form an end effector dimensioned for insertion into a sinus of a subject, the cutting involving laser machining.

[0030] The single piece of metal includes at least one of a tube and a plate. The end effector generally includes one or more deployable struts, at least some of the deployable struts having free distal ends. In some embodiments, a proximal portion of at least some of the struts includes one or more articulation sites to facilitate flexibility.

[0031] Another aspect of the invention provides a medical device including an end effector dimensioned for insertion into a paranasal sinus, the end effector comprising a plurality of struts extending in a radial configuration from a distal end of the effector, at least two of the struts connected by a cross member.

[0032] In some embodiments, the cross member comprises a flexible printed circuit board (PCB). In some embodiments, the cross member connects two immediately adjacent struts. In some embodiments, a plurality of struts are connected by a plurality of cross members. In some embodiments, substantially every other strut of the plurality of struts is connected by a corresponding cross member. In some embodiments, a plurality of struts are connected by a plurality of cross members at non-uniform locations along the length of the plurality of struts. In some embodiments, the cross member comprises one or more electrodes. In some embodiments, the plurality of struts and the cross member are transformable between a retracted configuration and a deployed configuration. In some embodiments, when in the deployed configuration, the cross member achieves a locked state and prevents retraction of the plurality of struts.

[0033] In some embodiments, the cross member comprises an articulating portion. In some embodiments, the cross member comprises an arcuate shape. In some embodiments, the cross member comprises a chevron shape. In some embodiments, the cross member is configured to affect the radial stiffness of at least two struts.

[0034] In some embodiments, each of the plurality of struts comprises a flexible PCB member configured to deliver energy to one or more target sites within the paranasal sinus.

[0035] In some embodiments, at least two of the flexible PCB members are configured to deliver different energy profiles from one another. The present invention provides, for example, the following. (Item 1) 1. A device for treating a condition within a patient's paranasal sinus, the device comprising: an end effector including one or more flexible printed circuit board (PCB) members for delivering energy to one or more target sites within the patient's paranasal sinus. (Item 2) Item 1, wherein each of the one or more flexible PCB members comprises a PCB substrate and one or more electrodes configured to deliver energy to tissue at the one or more target sites. (Item 3) 3. The device of claim 2, wherein each of the one or more flexible PCB members comprises one or more electrical communication paths that selectively couple the one or more electrodes to corresponding one or more electrical contacts located on or within the PCB substrate and configured to electrically couple the one or more electrodes to a controller. (Item 4) 3. The device of claim 2, wherein the end effector comprises one or more retractable and expandable sections with which the one or more flexible PCB members are operatively associated. (Item 5) Item 5. The device of item 4, wherein the end effector comprises a first retractable and expandable section comprising a plurality of first support structures to which one or more flexible PCB members are fixedly coupled. (Item 6) Item 6. The device of item 5, wherein when the first section is in an expanded configuration, the plurality of first support structures extend in a first direction relative to the shaft and form a first geometric shape. (Item 7) Item 7. The device of item 6, wherein the PCB substrate of the one or more flexible PCB members comprises a flexible material configured to transition from a corresponding collapsed configuration to an unfolded configuration upon movement of the first section to the expanded configuration. (Item 8) Item 8. The device of item 7, wherein each of the plurality of first support structures includes at least a portion of one or more flexible PCB members fixedly coupled thereto. (Item 9) Item 9. The device of item 8, wherein at least a first of the plurality of first support structures is configured in a loop or leaflet shape when the first section is in an expanded configuration, whereby a PCB substrate of a flexible PCB member operably associated with the first of the plurality of first support structures substantially covers the loop or leaflet shape in the expanded configuration. (Item 10) 7. The device of claim 6, wherein the first retractable and expandable section further comprises a plurality of second support structures to which one or more flexible PCB members are fixedly coupled, and wherein when the first section is in an extended configuration, the plurality of second support structures extend in an opposite second direction relative to the shaft of the device to form a second geometric shape. (Item 11) Item 11. The device of item 10, wherein each of the first and second geometric shapes comprises a concave shape. (Item 12) Item 12. The device of item 11, wherein the plurality of first support structures comprises at least a first pair of support elements that together form the concave shape relative to the shaft in the first direction when in the expanded configuration, and the plurality of second support structures comprises at least a second pair of support elements that together form the concave shape relative to the shaft in the second direction when in the expanded configuration. (Item 13) Item 11. The device of item 10, wherein the plurality of first and second support structures comprise deformable wires and / or struts. (Item 14) Item 14. The device of item 13, wherein the deformable wires and / or struts comprise a shape memory material. (Item 15) Item 15. The device of item 14, wherein the one or more flexible PCB members are fixedly coupled to the one or more deformable wires and / or struts via an adhesive. (Item 16) 7. The device of claim 6, wherein the end effector comprises a second retractable and expandable section to which one or more flexible PCB members are operatively associated. (Item 17) Item 17. The device of item 16, wherein the second section comprises a plurality of third support structures to which one or more flexible PCB members are fixedly coupled, and when the second section is in an expanded configuration, the plurality of third support structures extend in a third direction relative to the shaft and together form a peripheral shape of the open end. (Item 18) 3. The device of claim 2, wherein the one or more electrodes are configured to deliver radio frequency (RF) energy. (Item 19) 3. The device of claim 2, wherein the one or more flexible PCB members comprise a first subset of a plurality of elements provided on the PCB substrate, the first subset being configured to deliver non-therapeutic stimulation energy to tissue at the one or more target sites at frequencies to identify target and non-target tissue. (Item 20) 20. The device of claim 19, wherein the one or more flexible PCB members comprise a second subset of a plurality of elements provided on the PCB substrate, the second subset of elements configured to sense a property of at least one of the target tissue and non-target tissue in response to the non-therapeutic stimulation energy. (Item 21) 1. A method for treating an intra-sinus condition in a patient, the method comprising: providing a treatment device comprising an end effector including one or more flexible printed circuit board (PCB) members; advancing the end effector through the nasal passages and into the patient's sinuses until the one or more flexible PCB members are positioned at one or more target sites; delivering energy to tissue at the one or more target sites via the one or more flexible PCB members; A method comprising: (Item 22) Item 22. The method of item 21, wherein each of the one or more flexible PCB members comprises a PCB substrate and one or more electrodes configured to deliver energy to tissue at the one or more target sites. (Item 23) Item 23. The method of item 22, wherein each of the one or more flexible PCB members comprises one or more electrical communication paths that selectively couple the one or more electrodes to corresponding one or more electrical contacts located on or in the PCB substrate and configured to electrically couple the one or more electrodes to a controller. (Item 24) Item 23. The method of item 22, wherein the end effector comprises one or more retractable and expandable sections with which the one or more flexible PCB members are operatively associated. (Item 25) Item 25. The method of item 24, wherein the end effector comprises a first retractable and expandable section comprising a plurality of first support structures to which one or more flexible PCB members are fixedly coupled. (Item 26) Item 26. The method of item 25, further comprising transitioning the first section from a retracted configuration to an extended configuration, thereby extending the plurality of first support structures in a first direction relative to the shaft and forming a first geometric shape. (Item 27) Item 27. The method of item 26, wherein the PCB substrate of the one or more flexible PCB members comprises a flexible material configured to transition from a corresponding collapsed configuration to an unfolded configuration upon movement of the first section to the expanded configuration. (Item 28) Item 28. The method of item 27, wherein each of the plurality of first support structures includes at least a portion of one or more flexible PCB members fixedly coupled thereto. (Item 29) Item 29. The method of item 28, wherein at least a first of the plurality of first support structures is configured in a loop or lobular shape when the first section is in an expanded configuration, whereby a PCB substrate of a flexible PCB member operably associated with the first of the plurality of first support structures substantially covers the loop or lobular shape in the expanded configuration. (Item 30) Item 27. The method of item 26, wherein the first retractable and expandable section further comprises a plurality of second support structures to which one or more flexible PCB members are fixedly coupled, and when the first section is in an extended configuration, the plurality of second support structures extend in an opposite second direction relative to the shaft of the device to form a second geometric shape. (Item 31) Item 31. The method of item 30, wherein each of the first and second geometric shapes comprises a concave shape. (Item 32) Item 32. The method of item 31, wherein the plurality of first support structures comprises at least a first pair of support elements that together form the concave shape relative to the shaft in the first direction when in the expanded configuration, and the plurality of second support structures comprises at least a second pair of support elements that together form the concave shape relative to the shaft in the second direction when in the expanded configuration. (Item 33) Item 31. The method of item 30, wherein the plurality of first and second support structures comprises deformable wires and / or struts. (Item 34) Item 34. The method of claim 33, wherein the deformable wires and / or struts comprise a shape memory material. (Item 35) Item 35. The method of item 34, wherein the one or more flexible PCB members are fixedly coupled to the one or more deformable wires via an adhesive. (Item 36) Item 27. The method of item 26, wherein the end effector comprises a second retractable and expandable section to which one or more flexible PCB members are operatively associated. (Item 37) Item 37. The method of item 36, wherein the second section comprises a plurality of third support structures to which one or more flexible PCB members are fixedly coupled, the plurality of third support structures extending in a third direction relative to the shaft and cooperating to form a peripheral shape of an open end when the second section is in an expanded configuration. (Item 38) 23. The method of claim 22, wherein the one or more electrodes are configured to deliver radio frequency (RF) energy. (Item 39) Item 33. The method of item 32, wherein the one or more flexible PCB members comprise a first subset of a plurality of elements provided on the PCB board configured to deliver non-therapeutic stimulation energy to tissue at the one or more target locations at frequencies to identify target and non-target tissue. (Item 40) 40. The method of claim 39, wherein the one or more flexible PCB members comprise a second subset of a plurality of elements provided on the PCB substrate, the second subset being configured to sense a property of at least one of the target tissue and non-target tissue in response to the non-therapeutic stimulation energy. (Item 41) 1. A device for treating an intranasal condition, said device comprising: an end effector sized for insertion into the nasal cavity, said end effector comprising at least one section that is a unitary, single piece of material comprising a plurality of individual struts; a flexible printed circuit board (PCB) member attached to at least one of the struts; A device comprising: (Item 42) Item 42. The device of item 41, wherein the end effector comprises at least two sections including a distal section and a proximal section. (Item 43) Item 43. The device of item 42, wherein the distal section comprises a proximal end configured to be received by at least a portion of the proximal section. (Item 44) Item 43. The device of item 42, wherein the proximal section comprises at least one pair of struts, each of the struts having a first end and a second end each connected to a portion of the proximal section. (Item 45) Item 43. The device of item 42, wherein the distal section comprises struts that are deployable into a coaxial configuration relative to the longitudinal axis of the device. (Item 46) Item 42. The device of item 41, wherein the plurality of individual struts are transformable between a retracted configuration and a deployed configuration. (Item 47) Item 47. The device of item 46, wherein at least a portion of the plurality of individual struts are in a coaxial configuration relative to a longitudinal axis of the device, at least when in the deployed configuration. (Item 48) Item 47. The device of item 46, wherein at least a portion of the plurality of individual struts are in an annular configuration relative to a longitudinal axis of the device, at least when in the deployed configuration. (Item 49) Item 42. The device of item 41, wherein at least a portion of the plurality of individual struts include free distal ends. (Item 50) Item 42. The device of item 41, wherein at least some of the plurality of individual struts include one or more articulation sites that enhance flexibility of the struts. (Item 51) 51. The device of claim 50, wherein the one or more articulation sites comprise areas of reduced material. (Item 52) Item 52. The device of item 51, wherein the area of ​​reduced material forms an S-shaped configuration. (Item 53) Item 42. The device of item 41, wherein a portion of the plurality of individual struts are arranged around a periphery of the distal end of the end effector. (Item 54) Item 54. The device of item 53, wherein at least one of the plurality of individual struts comprises a stiffness different from the stiffness of a second strut. (Item 55) Item 42. The device of item 41, wherein the plurality of individual struts comprise at least two substantially flat faces that face each other. (Item 56) Item 42. The device of item 41, wherein each of the plurality of struts includes a corresponding flexible PCB member. (Item 57) Item 42. The device of item 41, further comprising a soft polymer disposed between the flexible PCB member and at least one of the plurality of individual struts. (Item 58) Item 42. The device of item 41, wherein the at least one section comprises a distal portion and a proximal portion, each of the distal portion and the proximal portion comprising at least one strut. (Item 59) Item 42. The device of item 41, wherein the flexible PCB member is configured to deliver energy to one or more target sites within the paranasal sinus. (Item 60) Item 42. The device of item 41, wherein at least some of the plurality of individual struts include connectors connecting different ones of the struts. (Item 61) providing an end effector dimensioned to be deployed at least partially inside a sinus of a patient; attaching a flexible printed circuit board (PCB) member to the end effector, the flexible PCB configured to deliver energy to a target site within the paranasal sinus; A method comprising: (Item 62) Item 62. The method of item 61, wherein the end effector comprises one or more deployable struts to which the flexible PCB member is attached. (Item 63) Item 63. The method of item 62, wherein at least some of the deployable struts include free distal ends. (Item 64) Item 62. The method of item 61, wherein the attaching involves at least one of a thermal process and a mechanical process. (Item 65) Item 65. The method of item 64, wherein the thermal process includes at least one of a reflow process, an induction heating process, a spot welding process, a lamination process, and a laser welding process. (Item 66) Item 66. The method of item 65, wherein the reflow process comprises polymer reflow. (Item 67) The thermal process comprises: Positioning the flexible PCB member on the effector; disposing one or more polymer layers around the flexible PCB member; Adding heat and Item 65. The method according to Item 64, comprising: (Item 68) Item 62. The method of item 61, wherein a polymer sleeve is affixed to a portion of the end effector via polymer modification, thereby providing a substrate to which the flexible PCB member is attached. (Item 69) Item 62. The method of item 61, wherein the flexible PCB member is machined from a single sheet of flexible PCB material. (Item 70) Item 62. The method of item 61, wherein a portion of the end effector comprises one or more fastening points to facilitate the attachment of at least one of the polymer sleeve and the flexible PCB to the end effector. (Item 71) Item 71. The method of item 70, wherein the one or more fixation points comprise recesses, holes, notches, or grooves etched into the end effector. (Item 72) Item 71. The method of item 70, wherein the one or more fixation points are located on a distal portion of the end effector. (Item 73) Item 62. The method of item 61, wherein at least a portion of the flexible PCB member is attached to the end effector by an adhesive. (Item 74) Item 74. The method of item 73, wherein the adhesive is applied to one or more fixing points located on the end effector prior to attachment to the flexible PCB member. (Item 75) Item 63. The method of item 62, wherein the deployable struts comprise opposing surfaces and the flexible members are attached to the opposing surfaces. (Item 76) providing a single piece of metal; cutting the single piece of metal to form an end effector dimensioned for insertion into a sinus of a subject; A method comprising: (Item 77) Item 77. The method of item 76, wherein the single piece of metal comprises at least one of a tube and a plate. (Item 78) Item 77. The method of item 76, wherein the end effector comprises one or more deployable struts, at least some of the deployable struts comprising free distal ends. (Item 79) Item 79. The method of item 78, wherein the proximal portion of at least some of the struts comprises one or more articulation sites that promote flexibility. (Item 80) Item 17. The method of item 16, wherein cutting involves laser machining. (Item 81) 1. A medical device comprising an end effector dimensioned for insertion into a nasal cavity, the end effector comprising a plurality of struts extending in a radial configuration from at least a distal end of the effector, at least two of the struts being connected by a cross member. (Item 82) Item 82. The device of item 81, wherein the cross member comprises a flexible printed circuit board (PCB). (Item 83) Item 82. The device of item 81, wherein the cross member connects two immediately adjacent struts. (Item 84) Item 82. The device of item 81, wherein the plurality of struts are connected by a plurality of cross members. (Item 85) Item 85. The device of item 84, wherein substantially every other one of the plurality of struts is connected by a corresponding cross member. (Item 86) Item 82. The device of item 81, wherein the plurality of struts are connected by a plurality of cross members at non-uniform locations along the length of the plurality of struts. (Item 87) Item 82. The device of item 81, wherein the cross member comprises one or more electrodes. (Item 88) Item 82. The device of item 81, wherein the plurality of struts and the cross member are transformable between a stored configuration and a deployed configuration. (Item 89) Item 91. The device of item 88, wherein when in a deployed configuration, the cross member achieves a locked state that prevents retraction of the plurality of struts. (Item 90) Item 82. The device of item 81, wherein the cross member comprises an articulating section. (Item 91) Item 82. The device of item 81, wherein the cross member comprises an arcuate shape. (Item 92) Item 82. The device of item 81, wherein the cross member comprises at least one of an S-shape and a chevron-shape. (Item 93) Item 82. The device of item 81, wherein the cross member is configured to influence at least one of the radial stiffness and the lateral stiffness of the at least two struts. (Item 94) Item 82. The device of item 81, wherein each of the plurality of struts comprises a flexible PCB member configured to deliver energy to one or more target sites within the nasal cavity. (Item 95) Item 95. The device of item 94, wherein at least two of the flexible PCB members are configured to deliver different energy profiles from one another. [Brief explanation of the drawings]

[0036] [Figure 1A] 1A and 1B are schematic diagrams of a system for treating a patient condition using a handheld device according to some embodiments of the present disclosure. [Figure 1B] 1A and 1B are schematic diagrams of a system for treating a patient condition using a handheld device according to some embodiments of the present disclosure.

[0037] [Figure 2]FIG. 2 is a schematic diagram of a console coupled to a handheld device consistent with the present disclosure, further illustrating one embodiment of an end effector of the handheld device for delivering energy to tissue at one or more target sites.

[0038] [Figure 3A] FIG. 3A is a cutaway side view illustrating the anatomy of the outer sinus wall.

[0039] [Figure 3B] FIG. 3B is an enlarged lateral view of the nerves of the lateral sinus wall of FIG. 1A.

[0040] [Figure 3C] FIG. 3C is a front view of the left palate bone illustrating the geometry of the microforamina within the left palate bone.

[0041] [Figure 4] FIG. 4 is a side view of one embodiment of a handheld device for providing therapeutic treatment consistent with the present disclosure.

[0042] [Figure 5A] 5A-5F are various views of a multi-segment end effector consistent with the present disclosure: Figure 5A is an enlarged perspective view of the multi-segment end effector illustrating the first (proximal) and second (distal) segments. [Figure 5B] FIG. 5B is an exploded perspective view of a multi-section end effector. [Figure 5C] FIG. 5C is an enlarged top view of the multi-section end effector. [Figure 5D] FIG. 5D is an enlarged side view of the multi-section end effector. [Figure 5E] FIG. 5E is an enlarged front (proximally facing) view of the first (proximal) section of the multi-section end effector. [Figure 5F] FIG. 5F is an enlarged front (proximally facing) view of the second (distal) section of the multi-section end effector.

[0043] [Figure 6] FIG. 6 is a perspective view of a portion of a support element, partially in cross section, illustrating exposed conductive wires that serve as energy delivery or electrode elements.

[0044] [Figure 7] FIG. 7 is a cross-sectional view of a portion of the shaft of the handheld device taken along line 7-7 of FIG.

[0045] [Figure 8A] FIG. 8A is a side view of the handle of the handheld device.

[0046] [Figure 8B] FIG. 8B is a side view of the handle illustrating the internal components enclosed therein.

[0047] [Figure 9A] 9A and 9B are enlarged perspective views of a second (distal) section of a multi-section end effector, including a flexible printed circuit board (PCB) assembly operatively associated therewith. [Figure 9B] 9A and 9B are enlarged perspective views of a second (distal) section of a multi-section end effector, including a flexible printed circuit board (PCB) assembly operatively associated therewith.

[0048] [Figure 10] FIG. 10 is an enlarged perspective view of a single loop strut or support element of the second (distal) section, illustrating an individual PCB member secured to a portion thereof.

[0049] [Figure 11] FIG. 11 is an enlarged plan view of one embodiment of a flexible PCB member consistent with the present disclosure.

[0050] [Figure 12]FIG. 12 is a cross-sectional view of a portion of the flexible PCB member taken along line 12-12 of FIG.

[0051] [Figure 13] FIG. 13 is an enlarged plan view of another embodiment of a flexible PCB member consistent with the present disclosure.

[0052] [Figure 14] FIG. 14 is a plan view of a flexible PCB assembly consistent with the present disclosure illustrating various portions of the assembly.

[0053] [Figure 15] FIG. 15 is an enlarged plan view of one embodiment of a flexible PCB member of a flexible PCB assembly consistent with the present disclosure.

[0054] [Figure 16A] 16A and 16B are enlarged plan views of the distal and proximal ends, respectively, of a flexible PCB assembly consistent with the present disclosure. [Figure 16B] 16A and 16B are enlarged plan views of the distal and proximal ends, respectively, of a flexible PCB assembly consistent with the present disclosure.

[0055] [Figure 17A] 17A and 17B are plan views of another embodiment of a flexible PCB assembly consistent with the present disclosure, illustrating the interleaving of two separate assemblies to form a combined assembly of overlapping flexible PCB members from each assembly. [Figure 17B] 17A and 17B are plan views of another embodiment of a flexible PCB assembly consistent with the present disclosure, illustrating the interleaving of two separate assemblies to form a combined assembly of overlapping flexible PCB members from each assembly.

[0056] [Figure 18A]18A, 18B, and 18C are top and side views, partially in cross section, of one embodiment of a jig assembly used to attach one or more flexible PCB members to individual support elements of the second (distal) section of the end effector. [Figure 18B] 18A, 18B, and 18C are top and side views, partially in cross section, of one embodiment of a jig assembly used to attach one or more flexible PCB members to individual support elements of the second (distal) section of the end effector. [Figure 18C] 18A, 18B, and 18C are top and side views, partially in cross section, of one embodiment of a jig assembly used to attach one or more flexible PCB members to individual support elements of the second (distal) section of the end effector.

[0057] [Figure 19] FIG. 19 is a perspective view of another embodiment of a jig assembly used to attach one or more flexible PCB members to individual support elements of the second (distal) section of the end effector.

[0058] [Figure 20] FIG. 20 is an enlarged side view of the first (proximal) section of a multi-section end effector illustrating the installation of a flexible PCB assembly, consisting of multiple flexible PCB members, onto various support elements of the first (proximal) section.

[0059] [Figure 21] FIG. 21 is an image illustrating a perspective view of the first (proximal) section, including a flexible PCB assembly attached to a support element.

[0060] [Figure 22] FIG. 22 is a perspective view of one embodiment of a jig assembly used to attach one or more flexible PCB members to the individual support elements of the first (distal) section of the end effector. [Figure 23] FIG. 23 is an enlarged view of the jig assembly of FIG.

[0061] [Figure 24] 24 is an enlarged view of an alternative embodiment of the jig assembly of FIG.

[0062] [Figure 25] FIG. 25 is an enlarged perspective view of the multi-stage end effector illustrating a flexible PCB member coupled to the loop struts or support elements of each of the first (proximal) and second (distal) sections, the flexible PCB member substantially covering the loop or leaflet shape when in the deployed configuration.

[0063] [Figure 26] FIG. 26 is a side perspective view of another embodiment of a multi-section end effector consistent with the present disclosure.

[0064] [Figure 27A] 27A and 27B are perspective views of a portion (first interlocking member) of the proximal section of the end effector of FIG. 26. FIG. [Figure 27B] 27A and 27B are perspective views of a portion (first interlocking member) of the proximal section of the end effector of FIG. 26. FIG.

[0065] [Figure 27C] 27C and 27D are side and front facing perspective views of a portion (second interlocking member) of the proximal section of the end effector of FIG. 26. [Figure 27D] 27C and 27D are side and front facing perspective views of a portion (second interlocking member) of the proximal section of the end effector of FIG. 26.

[0066] [Figure 28] 28 is a perspective view of a distal section of the end effector of FIG. 26. FIG.

[0067] [Figure 29]FIG. 29 is a top view of a single workpiece of material from which the distal section of FIG. 28, specifically the multiple support elements / struts, are constructed via a laser machining process.

[0068] [Figure 30A] 30A and 30B are perspective and side views of the distal section illustrating the fixation points defined on each of the multiple support elements / struts. [Figure 30B] 30A and 30B are perspective and side views of the distal section illustrating the fixation points defined on each of the multiple support elements / struts.

[0069] [Figure 31] FIG. 31 is a plan view of a single workpiece of material from which the distal section of FIGS. 30A-30B, specifically the multiple support elements / struts and associated fixation points, are constructed via a laser machining process.

[0070] [Figure 32A] 32A and 32B are side views of a single workpiece of material, generally in the form of a tube, from which a distal section is constructed via a laser machining process. [Figure 32B] 32A and 32B are side views of a single workpiece of material, generally in the form of a tube, from which a distal section is constructed via a laser machining process.

[0071] [Figure 33] FIG. 33 is a perspective view of the distal section illustrating various anchoring point designs provided on one or more of the multiple support elements / struts.

[0072] [Figure 34] FIG. 34 is a perspective view of the proximal section illustrating various anchoring point designs provided on one or more of the multiple support elements / struts.

[0073] [Figure 35] FIG. 35 is a perspective view illustrating the coupling of a flexible PCB member to a corresponding support element / strut of the distal section of FIGS. 30A-30B using fastening points.

[0074] [Figure 36] FIG. 36 is a perspective view of the distal section of FIGS. 30A-30B, including an enlarged view illustrating the use of a polymer overlay to join the flexible PCB members to the corresponding support elements / struts of the distal section.

[0075] [Figure 37] FIG. 37, for example, is a perspective view of the distal section of FIGS. 9A-9B illustrating the mounting of a polymer sleeve over the wire support elements of the distal section, with a flexible PCB joined to the polymer sleeve.

[0076] [Figure 38] FIG. 38 is a perspective view of the distal section of FIG. 28 illustrating the placement of a polymer cap or tubing on the free distal end of the support element / strut.

[0077] [Figure 39] Figures 39 and 40 are enlarged views illustrating the placement of a polymer sleeve over the support element / strut of the distal section of Figure 29. Figure 39 illustrates the sleeve extending along the length of the support element / strut, while Figure 40 illustrates discrete portions of the polymer sleeve positioned along the length of the support element / strut (generally forming runners at specific locations on the support element / strut). [Figure 40] Figures 39 and 40 are enlarged views illustrating the placement of a polymer sleeve over the support element / strut of the distal section of Figure 29. Figure 39 illustrates the sleeve extending along the length of the support element / strut, while Figure 40 illustrates discrete portions of the polymer sleeve positioned along the length of the support element / strut (generally forming runners at specific locations on the support element / strut).

[0078] [Figure 41] FIG. 41 is a perspective view of the distal section, where each of the plurality of support elements / struts includes a polymer sleeve extending the majority of its length and further includes a flexible PCB member attached thereto.

[0079] [Figure 42] FIG. 42 is a perspective view of the distal section, with each of the multiple support elements / struts including polymer runners provided at discrete locations along their length, and further including a flexible PCB member attached to the runners on each support element / strut.

[0080] [Figure 43] FIG. 43 is a perspective view of the distal section, where each of the support elements / struts are laser cut and further include multiple fixation points to which a flexible PCB member can be attached.

[0081] [Figure 44A] 44A, 44B, 44C, and 44D illustrate the reflow process for positioning and affixing the flexible PCB member and polymer tubing to the struts of the proximal section. [Figure 44B] 44A, 44B, 44C, and 44D illustrate the reflow process for positioning and affixing the flexible PCB member and polymer tubing to the struts of the proximal section. [Figure 44C] 44A, 44B, 44C, and 44D illustrate the reflow process for positioning and affixing the flexible PCB member and polymer tubing to the struts of the proximal section. [Figure 44D] 44A, 44B, 44C, and 44D illustrate the reflow process for positioning and affixing the flexible PCB member and polymer tubing to the struts of the proximal section.

[0082] [Figure 45A]45A and 45B illustrate the reflow process for positioning and affixing the flexible PCB member and polymer tubing to the support elements / struts of the distal section. [Figure 45B] 45A and 45B illustrate the reflow process for positioning and affixing the flexible PCB member and polymer tubing to the support elements / struts of the distal section.

[0083] [Figure 46] FIG. 46 is a perspective view of the distal section, in which multiple support elements / struts are connected by cross members in a first configuration (i.e., an S-shaped or chevron-shaped pattern), with immediately adjacent support elements / struts connected to each other.

[0084] [Figure 47] FIG. 47 is a perspective view of the distal section, in which the plurality of support elements / struts are connected by cross members in a second configuration, with every other one of the plurality of support elements / struts being connected by a corresponding cross member.

[0085] [Figure 48A] 48A and 48B are side views illustrating the transition of the distal section to the expanded, deployed configuration and the corresponding movement of the cross member locking mechanism to interconnect at least two support elements / struts when the section is in the fully deployed configuration, achieving a locked state and thereby preventing retraction of multiple support elements / struts. [Figure 48B] 48A and 48B are side views illustrating the transition of the distal section to the expanded, deployed configuration and the corresponding movement of the cross member locking mechanism to interconnect at least two support elements / struts when the section is in the fully deployed configuration, achieving a locked state and thereby preventing retraction of multiple support elements / struts.

[0086] [Figure 49A]49A-49C are perspective views of the distal section, each including an embodiment of a looped strut comprising two portions that are interconnected and that together form the looped strut. [Figure 49B] 49A-49C are perspective views of the distal section, each including an embodiment of a looped strut comprising two portions that are interconnected and that together form the looped strut. [Figure 49C] 49A-49C are perspective views of the distal section, each including an embodiment of a looped strut comprising two portions that are interconnected and that together form the looped strut. [Figure 50] FIG. 50 is a perspective view of a distal section, each including another embodiment of looped struts comprising two portions that interconnect and jointly form the looped strut.

[0087] [Figure 51A] 51A and 51B are perspective views of the distal section, each including another embodiment of a looped strut comprising two portions that are mechanically coupled to one another and that together form the looped strut. [Figure 51B] 51A and 51B are perspective views of the distal section, each including another embodiment of a looped strut comprising two portions that are mechanically coupled to one another and that together form the looped strut.

[0088] [Figure 52] 52 and 53 are plan views of a single workpiece of material from which either the proximal or distal section, specifically multiple support elements / struts, are constructed via a laser machining process. [Figure 53] 52 and 53 are plan views of a single workpiece of material from which either the proximal or distal section, specifically multiple support elements / struts, are constructed via a laser machining process.

[0089] [Figure 54]Figures 54 and 55 are perspective views of the distal section of Figure 28, each illustrating the installation of polymer tubing onto the free distal ends of the support elements / struts, and further joining adjacent struts to one another via the installation of wire or braided tubing over the respective distal ends of adjacent struts, and securing the wire or braided tubing in place via a polymer reflow process. [Figure 55] Figures 54 and 55 are perspective views of the distal section of Figure 28, each illustrating the installation of polymer tubing onto the free distal ends of the support elements / struts, and further joining adjacent struts to one another via the installation of wire or braided tubing over the respective distal ends of adjacent struts, and securing the wire or braided tubing in place via a polymer reflow process. DETAILED DESCRIPTION OF THE INVENTION

[0090] Detailed Description There are various conditions related to the paranasal sinuses, which can affect breathing and other functions of the nose. One of the more common conditions is rhinitis, which is defined as inflammation of the nasal lining. Symptoms of rhinitis include sinus blockage, nasal obstruction, nasal congestion, sinus secretions (e.g., rhinorrhea and / or post-sinus drainage), facial pain, facial pressure, and / or reduced or complete loss of smell and / or taste. Sinusitis is another common condition, which involves inflammation or swelling of the tissues lining the sinuses and can lead to subsequent symptoms. Rhinitis and sinusitis are frequently associated with each other, as rhinitis often precedes sinusitis. Therefore, the term "rhinosinusitis" is often used to describe both conditions.

[0091] Depending on the duration and type of system, rhinosinusitis can be divided into different subtypes, including allergic rhinitis, non-allergic rhinitis, chronic rhinitis, acute rhinitis, recurrent rhinitis, chronic sinusitis, acute sinusitis, recurrent sinusitis, and medically resistant rhinitis and / or sinusitis, as well as a combination of one or more of the preceding conditions. Note that an acute rhinosinusitis condition is one in which symptoms last for less than 12 weeks, while a chronic rhinosinusitis condition refers to symptoms that last for more than 12 weeks.

[0092] Recurrent rhinosinusitis refers to four or more episodes of acute rhinosinusitis within a 12-month period, with symptomatic remission between episodes. Numerous environmental and biological causes of rhinosinusitis exist. Non-allergic rhinosinusitis can be caused by, for example, environmental irritants, medications, foods, hormonal changes, and / or sinus septal deviations. Allergic rhinitis triggers can include exposure to seasonal allergens, year-round perennial allergens, and / or occupational allergens. Rhinosinusitis therefore affects millions of people and is a leading cause of patients seeking medical attention.

[0093] The present invention recognizes that problems with current surgical procedures are that they are imprecise, cause significant collateral damage, and are limited within certain treatment areas. The present invention solves that problem by providing a treatment device with unique end effectors configured to complement anatomical structures at multiple different locations within a paranasal sinus. The end effectors each include one or more retractable and expandable sections with a framework of support elements having elastic properties. Once delivered into a paranasal sinus, the one or more sections expand to a specific shape and / or size that corresponds to the anatomical structure within the paranasal sinus and is associated with the target site, and can receive delivery of therapeutic energy for treatment of a condition (i.e., rhinosinusitis or the like). Each retractable and expandable section includes one or more flexible printed circuit board (PCB) members provided thereon. The flexible PCB members are made of a flexible material that can move (e.g., bend, twist, fold, etc.) between various positions in response to movement of the underlying retractable and expandable sections attached thereto. Each flexible PCB member further includes one or more energy delivery elements (e.g., electrodes) provided thereon and configured to deliver energy to tissue associated with one or more target sites within the paranasal sinus.

[0094] The present invention utilizes many of the benefits of flexible PCBs as well as certain manufacturing techniques to provide an end effector that is highly conformable to anatomical variations within the sinuses so that an operator can perform precise, minimally invasive, and localized application of energy to one or more target sites within a patient's sinuses, thereby treating sinus conditions.

[0095] In particular, the underlying design of the end effector is unique. In a preferred embodiment, the end effector is multi-sectioned and includes a proximal section and a distal section. The proximal and distal sections are constructed from a single, integral workpiece having elastic properties. More specifically, a single piece of shape-memory material, such as Nitinol, may be used to construct one or more portions of the proximal section and the distal section as a whole. For example, in one embodiment, the proximal section is comprised of a pair of interlocking members, while the distal section is comprised of a single member. The pair of interlocking members of the proximal section includes a first member providing a first set of support elements and a second member providing a second set of support elements. Thus, each of the first and second members may be constructed from a single workpiece and subsequently interlocked within one another to form the proximal section, while the distal section comprises a single component (as opposed to an interlocking component) and is thus formed from a single workpiece.

[0096] A single workpiece may initially be in the form of a tube or flat plate and laser cut to form the desired framework of the support elements for the proximal and distal sections. In addition to reducing time, cost, and complexity, the use of laser machining allows manufacturers a greater amount of design freedom, which in turn leads to more tailored geometries and mechanical properties for a given section of the end effector. For example, laser machining allows for greater control of the mechanical properties of the support elements, including tailoring the stiffness of a specific one or a given group of support elements for a given section, thereby enabling tailored tissue contact profiles when a given section is in the expanded, deployed configuration. Furthermore, utilizing raw material workpieces in the form of tubes or flat plates results in support elements with relatively flat surfaces onto which corresponding flexible PCB members are affixed, thereby improving adhesion of the PCB members to tissue within the sinus.

[0097] Furthermore, the use of flexible PCB members provides a greater amount of usable surface area than would otherwise be available with existing end effectors. The increased surface area allows a greater number of energy delivery elements to be introduced and utilized in a given procedure, further expanding the number of possible patterns of such energy delivery elements. As a result, the contact surface is substantially increased, thereby enabling the end effector of the present invention to deliver treatment to areas within the sinuses that may previously have been inaccessible or untreatable with current treatment devices, or that previously required the surgeon to reposition a given device to reach such areas. The use of flexible PCB members also reduces the overall complexity associated with manufacturing the end effector of the present invention. In particular, any given flexible PCB member (including the overall PCB assembly, including multiple PCB members) is constructed separately from the end effector, which includes building the overall electrode design and installation on the given PCB member. Once the PCB assembly is completed, the PCB members are then attached to individual portions of a given section of the end effector as a separate manufacturing step, thereby reducing the complexity otherwise associated with placing electrodes directly on the end effector, which is common practice.

[0098] The present invention provides improved manufacturing techniques for joining PCB members to support elements of a given proximal or distal section. In particular, the present invention contemplates the use of bonding, thermal, and mechanical processes to join PCB members to individual support elements, which may include one or more of adhesive, mechanical, laminating, polymer reflow, induction heating, spot welding, and laser welding processes. For example, in one embodiment, attaching PCB members to individual support elements includes a reflow process in which a flexible PCB member is positioned against the individual support element, one or more polymer layers are then disposed around the flexible PCB member, and heat is then applied, resulting in the one or more polymer layers surrounding the flexible PCB member and subsequently affixing the flexible PCB member to the underlying support element of the end effector section. In another embodiment, a polymer sleeve may be affixed to the support element, thereby providing a substrate onto which a flexible PCB member may be positioned and subsequently attached. It should be noted that the processes of adhering the polymer sleeve and bonding the flexible PCB member to the support element may occur simultaneously through the application of pressure and heat.

[0099] In some embodiments, one or more of the support elements of the lower proximal and distal sections of the end effector may further include fastening points to facilitate attachment and alignment of the polymer sleeve and / or flexible PCB member thereto. For example, one or more of the support elements may include recesses, holes, notches, grooves, etchings, or the like, to increase surface area and receive a pool of adhesive or molten polymer to mechanically secure the sleeve and / or PCB member in place, ensure alignment, and simplify assembly.

[0100] Thus, the present invention provides an end effector that is highly conformable to anatomical variations within the sinus, allowing an operator to perform precise, minimally invasive, and localized application of energy to one or more target sites within a patient's sinuses, thereby treating the sinus condition. Unlike other surgical procedures, particularly for rhinitis, the device of the present invention is minimally invasive. Once delivered into the sinus, each segment of the end effector can expand to a specific shape and / or size that corresponds to the anatomical structure within the sinus and is associated with the target site. More specifically, each of the first and second segments, when in the deployed configuration, includes a specific geometry to complement the anatomy of a particular location within the sinus. The multiple flexible PCB members attached to the respective first and second sections, once deployed, are capable of correspondingly moving and transitioning to the specific geometry of a given section such that the flexible PCBs of the first and second sections contact and conform to the shape of the respective locations, including conforming to and complementing the shape of one or more anatomical structures at the respective locations.

[0101] In turn, the multiple flexible PCB members of the first and second sections become precisely positioned within the paranasal sinuses and subsequently deliver a precise and focused application of energy via one or more electrodes to targeted tissue at one or more target sites, disrupting multiple nerve signals to mucus-producing and / or mucosal congestion elements and / or causing local hypoxia thereof, thereby reducing mucus production and / or mucosal congestion within the patient's nose and reducing or eliminating one or more symptoms associated with at least one of rhinitis, nasal congestion, and rhinorrhea.

[0102] Thus, the handheld device of the present invention provides a user-friendly, non-invasive means of treating rhinosinusitis conditions, including precise and focused application of energy to intended, targeted tissues without causing collateral and unintended damage or disruption to other tissues and / or structures. Thus, the effectiveness of vidian nerve transection procedures can be achieved using the systems and methods of the present invention without the drawbacks discussed above. Most notably, the handheld device provides surgeons with a user-friendly, non-invasive, and precise means for treating rhinorrhea and other symptoms of rhinosinusitis by targeting only those specific structures associated with such conditions, thereby significantly reducing the risk of causing collateral damage or disruption to other tissues and / or structures, thereby ensuring that such procedures are effective in treating rhinosinusitis conditions while reducing the likelihood of unintended complications and side effects.

[0103] While many of the present embodiments are described with respect to devices, systems, and methods for therapeutically modulating nerves associated with the peripheral nervous system (PNS), and thus treating peripheral neurological conditions or disorders, it should be noted that other applications and embodiments in addition to those described herein are within the scope of the present disclosure. For example, at least some embodiments of the present disclosure may be useful for the treatment of other disorders, such as the treatment of disorders associated with the central nervous system.

[0104] 1A and 1B are schematic diagrams of a therapeutic system 100 for treating a patient condition using a handheld device 102, according to some embodiments of the present disclosure. The system 100 generally includes the device 102 and a console 104 to which the device 102 is connected. FIG. 2 is a schematic diagram of the console 104 coupled to the handheld device 102, illustrating an exemplary embodiment of an end effector 114 for delivering energy to tissue at one or more target sites in a patient for treatment of the condition. As shown, the device 102 is a handheld device including the end effector 114, a shaft 116 operably associated with the end effector 114, and a handle 118 operably associated with the shaft 116. The end effector 114 is collapsible / retractable and expandable, thereby allowing the end effector 114 to be minimally invasive upon delivery to one or more target sites within a patient (i.e., in a collapsed or retracted state), and then can be expanded once positioned at the target site. It should be noted that the terms "end effector" and "treatment assembly" may be used interchangeably throughout this disclosure.

[0105] For example, a surgeon or other medical professional performing a procedure can utilize the handle 118 to manipulate and advance the shaft 116 to a desired target site, the shaft 116 configured to position at least its distal portion within a lumen at a treatment or target site within a portion of a patient associated with the tissue to receive electrical therapeutic stimulation for subsequent treatment of an associated condition or disorder. When the tissue to be treated is a nerve, the target site may generally be associated with peripheral nerve fibers such that the electrical therapeutic stimulation results in treatment of the associated neurological condition. The target site may be a region, volume, or area in which the target nerve is located and may vary in size and shape depending on the patient's anatomy. Once positioned, the end effector 114 may be deployed and subsequently deliver energy to one or more target sites. The delivered energy may be non-therapeutic stimulation energy at a frequency for identifying and sensing one or more properties of the nerve tissue. For example, the end effector 114 may include an electrode array including at least a subset of the electrodes configured to sense the presence of neural tissue and the morphology of the neural tissue at each individual location of the electrodes, and such data may be used to determine the type, depth, and location of the neural tissue via the console 104.

[0106] Based on the identification of the neural tissue type, the console 104 is configured to determine a specific treatment pattern to control the delivery of energy from the end effector 114 on the target site to the tissue of interest (i.e., the targeted tissue) at a specific level and for a specific time period sufficient to ensure successful ablation / modulation of the targeted tissue while minimizing and / or preventing collateral damage to surrounding or adjacent non-targeted tissue at the target site. Thus, the end effector 114 is capable of therapeutically modulating nerves of interest, particularly nerves associated with a peripheral neurological condition or disorder, to treat such condition or disorder while minimizing and / or preventing collateral damage.

[0107] For example, the end effector 114 may include at least one energy delivery element, such as an electrode, configured to deliver energy to a target tissue, which may be used to sense the presence and / or specific properties of tissue (such tissue including, but not limited to, muscle, nerve, blood vessel, bone, etc.) for therapeutically modulating a tissue of interest, such as neural tissue. For example, one or more electrodes may be provided by one or more portions of the end effector 114, and the electrodes may be configured to apply electromagnetic neuromodulation energy (e.g., radio frequency (RF) energy) to a target site. In other embodiments, the end effector 114 may include other energy delivery elements configured to provide therapeutic neuromodulation using various other modalities, such as cryotherapeutic cooling, ultrasound energy (e.g., high-intensity focused ultrasound (“HIFU”) energy), microwave energy (e.g., via a microwave antenna), direct heating, high- and / or low-power laser energy, mechanical vibration, and / or light power.

[0108] In some embodiments, the end effector 114 may include one or more sensors (not shown), such as one or more temperature sensors (e.g., thermocouples, thermistors, etc.), impedance sensors, and / or other sensors. The sensors and / or electrodes may be connected to one or more wires extending through the shaft 116 and configured to transmit signals to and from the sensors and / or transfer energy to the electrodes.

[0109] As shown, device 102 is operably coupled to console 104 via a wired connection, such as cable 120. However, it should be noted that device 102 and console 104 may also be operably coupled to each other via a wireless connection. Console 104 is configured to provide various functions for device 102, which may include, but are not limited to, controlling, monitoring, supplying, and / or otherwise supporting operation of device 102. For example, when device 102 is configured for electrode-based, thermal element-based, and / or transducer-based treatment, console 104 may include an energy generator 106 configured to generate RF energy (e.g., monopolar, bipolar, or multipolar RF energy), pulsed electrical energy, microwave energy, optical energy, ultrasound energy (e.g., intraluminally delivered ultrasound and / or HIFU), direct thermal energy, radiation (e.g., infrared, visible, and / or gamma radiation), and / or another suitable type of energy.

[0110] In some embodiments, the console 104 may include a controller 107 communicatively coupled to the device 102. However, in the embodiments described herein, the controller 107 may generally be carried by or provided within the handle 118 of the device 102. The controller 107 is configured to initiate, terminate, and / or regulate, directly and / or via the console 104, the operation of one or more electrodes provided by the end effector 114. For example, the controller 107 may be configured to execute automatic control algorithms and / or receive control commands from an operator (e.g., a surgeon or other medical professional or clinician). For example, the controller 107 and / or other components of the console 104 (e.g., processor, memory, etc.) may include computer-readable media that carry instructions that, when executed by the controller 107, cause the device 102 to perform a certain function (e.g., apply energy in a specific manner, detect impedance, detect temperature, detect nerve location or anatomical structure, etc.). Memory may include one or more of a variety of hardware devices for volatile and non-volatile storage, and may include both read-only and writable memory. For example, memory may comprise random access memory (RAM), CPU registers, read-only memory (ROM), and writable non-volatile memory such as flash memory, hard drives, floppy disks, CDs, DVDs, magnetic storage devices, tape drives, device buffers, etc. Memory is not a propagating signal separate from the underlying hardware; memory is therefore non-transitory.

[0111] The console 104 may further be configured to provide feedback to the operator before, during, and / or after a treatment procedure via the evaluation / feedback algorithm 110. For example, the evaluation / feedback algorithm 110 can be configured to provide information associated with the location of nerves at the treatment site, the temperature of tissue at the treatment site, and / or the effect of therapeutic neuromodulation on nerves at the treatment site. In an embodiment, the evaluation / feedback algorithm 110 can include features for confirming the effectiveness of the treatment and / or promoting desired performance of the system 100. For example, the evaluation / feedback algorithm 110, in conjunction with the controller 107, can be configured to monitor the temperature at the treatment site during treatment and automatically stop energy delivery when the temperature reaches a predetermined maximum value (e.g., when applying RF energy) or a predetermined minimum value (e.g., when applying cryotherapy). In other embodiments, the evaluation / feedback algorithm 110, in conjunction with the controller 107, can be configured to automatically terminate treatment after a predetermined maximum time, a predetermined maximum impedance rise in the target tissue (i.e., compared to a baseline impedance measurement), a predetermined maximum impedance in the target tissue, and / or other thresholds for biomarkers associated with autonomous function. Books and other information associated with the operation of the system 100 are communicated to the operator via a graphical user interface (GUI) 112 provided via a display on the console 104 and / or a separate display (not shown) communicatively coupled to the console 104, such as a tablet or monitor, and thus can provide visual and / or audible alerts to the operator. The GUI 112 may generally provide operational instructions for the procedure, such as prompting the operator to select a sinus to treat, and further providing the status of the treatment during the procedure, including indicating when the device 102 is primed and ready to perform treatment, and indicating when the treatment is complete.

[0112] For example, in some embodiments, the end effector 114 and / or other portions of the system 100 can be configured to detect various parameters of foreign tissue at the target site, determine anatomical structures at the target site (e.g., tissue type, tissue location, vasculature, bone structures, foramina, sinuses, etc.), identify nerves and / or other structures, and enable neural mapping. For example, the end effector 114 may be configured to detect impedance, dielectric properties, temperature, and / or other properties indicative of the presence of nerve fibers within the target region.

[0113] 1A , the console 104 may further include a monitoring system 108 configured to receive data (i.e., detected electrical and / or thermal measurements of the tissue at the target site) from the end effector 114, specifically as sensed by appropriate sensors (e.g., temperature and / or impedance sensors, or the like), process this information, and identify the presence of nerves, the location of the nerves, neural activity at the target site, and / or other properties of the neural tissue, such as physiological properties (e.g., depth), bioelectrical properties, and thermal properties. The neural monitoring system 108 may be operatively coupled to the electrodes and / or other features of the end effector 114 via signal wires (e.g., copper wires) extending through the cable 120 and through the length of the shaft 116. In other embodiments, the end effector 114 may be communicatively coupled to the neural monitoring system 108 using other suitable communication means.

[0114] The neuromonitoring system 108 can determine nerve location and activity before therapeutic neuromodulation and determine a precise treatment area corresponding to the desired nerve location. The neuromonitoring system 108 can further be used to determine the effectiveness of the therapeutic neuromodulation during treatment and / or to evaluate whether the therapeutic neuromodulation treated the target nerve to the desired extent after treatment. This information can be used to make various determinations related to nerves proximate to the target site, such as whether the target site is suitable for neuromodulation. In addition, the neuromonitoring system 108 can also compare the detected nerve location and / or activity before and after therapeutic neuromodulation, compare the change in neural activity to a pre-determined threshold, and assess whether the application of therapeutic neuromodulation was effective across the treatment site. For example, the neuromonitoring system 108 can further determine an electroneurogram (ENG) signal based on recordings of neuronal electrical activity obtained by the end effector 114 before and after therapeutic neuromodulation. A statistically significant (e.g., measurable or significant) decrease in the ENG signal obtained after neuromodulation can serve as an indicator that the nerve has been sufficiently ablated. Additional features and functions of the neuromonitoring system 108 and other functions of the various components of the console 104, including the assessment / feedback algorithm 110 for providing real-time feedback capabilities to ensure optimal therapy is administered for a given procedure, are described in at least U.S. Publication Nos. 2016 / 0331459 and 2018 / 0133460, the contents of each of which are incorporated herein by reference in their entirety.

[0115] The device 102 provides access to target sites associated with peripheral nerves for subsequent neuromodulation of such nerves and treatment of corresponding peripheral neurological conditions or disorders. The peripheral nervous system is one of two components that make up the nervous system of bilateral animals; the other is the central nervous system (CNS). The PNS consists of nerves and ganglia outside the brain and spinal cord. The primary function of the PNS is to connect the CNS to the limbs and organs, essentially serving as a relay between the brain and spinal cord and the rest of the body. The peripheral nervous system is divided into the somatic nervous system and the autonomic nervous system. In the somatic nervous system, cranial nerves, with the exception of the optic nerve (cranial nerve II), along with the retina, are part of the PNS. The cranial nerve II is not a true peripheral nerve but is a diencephalic tract. Cranial ganglia originate in the CNS. However, the remaining 10 cranial nerve axons extend beyond the brain and are therefore considered part of the PNS. The autonomic nervous system exerts involuntary control over smooth muscle and glands. The connections between the CNS and organs allow the body system to be in two distinct functional states: sympathetic and parasympathetic. Thus, the devices, systems, and methods of the present invention are useful in detecting, identifying, and precisely targeting nerves associated with the peripheral nervous system for the treatment of corresponding peripheral neurological conditions or disorders.

[0116] Peripheral neurological conditions or disorders may include, but are not limited to, chronic pain, movement disorders, epilepsy, psychiatric disorders, cardiovascular disorders, gastrointestinal disorders, and genitourinary disorders, to name a few. For example, chronic pain may include headache, complex regional pain syndrome, neuropathy, peripheral neuralgia, ischemic pain, post-spinal surgery pain syndrome, and trigeminal neuralgia. Movement disorders may include spasticity, Parkinson's disease, tremor, dystonia, Tourette's syndrome, hypsatropia, hemifacial spasm, and Meige syndrome. Psychiatric disorders may include depression, obsessive-compulsive disorder, drug addiction, and appetite / eating disorders. Functional recovery may include recovery of certain functions after traumatic brain injury, hearing loss, and blindness. Cardiovascular disorders may include angina, heart failure, hypertension, peripheral vascular disease, and stroke. Gastrointestinal disorders may include movement disorders and obesity. Genitourinary disorders may include bladder pain syndrome, interstitial cystitis, and voiding dysfunction.

[0117] For example, system 100 may be used for the treatment of cardiovascular disorders such as arrhythmias or heart rhythm disorders, including, but not limited to, atrial fibrillation (AF or A-fib). Atrial fibrillation is an irregular, often rapid, heart rate that can increase an individual's risk of stroke, heart failure, and other heart-related complications. Atrial fibrillation occurs when an area of ​​cardiac tissue abnormally conducts electrical signals to adjacent tissue, thereby disrupting the normal cardiac cycle and causing an asynchronous rhythm. Atrial fibrillation symptoms often include heart palpitations, shortness of breath, and weakness. While episodes of atrial fibrillation can come and go, individuals may develop atrial fibrillation that does not go away and therefore requires treatment. While atrial fibrillation itself is not usually life-threatening, it can lead to complications and is therefore a serious medical condition that sometimes requires emergency treatment. For example, atrial fibrillation is associated with an increased risk of heart failure, dementia, and stroke.

[0118] The heart's normal electrical conduction system allows impulses generated by the heart's sinoatrial node (SA node) to propagate to and stimulate the myocardium (muscle layer of the heart). When stimulated, the myocardium contracts. It is the orderly stimulation of the myocardium that allows the heart to contract efficiently, thereby pumping blood through the body. In AF, the normal orderly electrical impulses generated by the sinoatrial node in the heart's right atrium are overwhelmed by chaotic electrical impulses, usually originating at the base of the pulmonary veins. This leads to irregular conduction of the ventricular impulses that generate the heartbeat. Specifically, during AF, the heart's two upper chambers (atria) beat chaotically and irregularly, out of coordination with the heart's two lower chambers (ventricles).

[0119] During atrial fibrillation, the regular impulses generated by the sinus node for a normal heartbeat are overwhelmed by rapid discharges generated within the adjacent atria and pulmonary veins. These sources of disturbance are often either an autofocus identified in one of the pulmonary veins or a few localized sources in the form of reentrant leading circles or electrical spiral waves (rotators). These localized sources may be found within the left atrium near the pulmonary veins or at various other locations throughout both the left and right atria. There are three basic components that favor the establishment of a leading circle or rotator: 1) a slow conduction velocity of the myocardial action potential, 2) a short refractory period, and 3) a small wavelength. Wavelength is the product of velocity and refractory period. If the action potential has fast conduction with a long refractory period and / or a conduction path shorter than the wavelength, an AF focus will not be established. In multiwavelet theory, a wavefront will break down into smaller daughter wavelets when it encounters an obstacle through a process called vortex shedding, but under suitable conditions, such wavelets can reform, rotate around a center, and form an AF focus.

[0120] System 100 provides treatment for AF, where device 102 may provide access to and provide treatment for one or more target sites associated with nerves corresponding to or otherwise associated with treating AF. For example, device 102, in conjunction with console 104, may detect, identify, and precisely target cardiac tissue and subsequently deliver energy at a level or frequency sufficient to therapeutically modulate nerves associated with such cardiac tissue. Therapeutic modulation of such nerves is sufficient to disrupt the origin of signals causing AF and / or disrupt the conduction pathways for such signals.

[0121] Similar to the cardiac conduction system, there is a neural network surrounding the heart that plays an important role in forming the substrate for AF. AF usually occurs when triggers are generated from the pulmonary vein sleeve. This neural network includes ganglionated plexuses (GPs) located adjacent to the pulmonary vein ostia, which are under higher central control in normal people. For example, the heart is richly innervated by autonomic nerves. Autonomic ganglion cells are located either outside the heart (extrinsic) or inside the heart (intrinsic). Both the extrinsic and intrinsic nervous systems are important for cardiac function and arrhythmogenesis. The vagus nerve contains axons arising from various nuclei within the medulla. Extrinsic sympathetic nerves arise from paravertebral ganglia, including the superior cervical ganglion, middle cervical ganglion, cervicothoracic (stellate) ganglion, and thoracic ganglion. Intrinsic cardiac nerves are found mostly within the atria and are closely involved in atrial arrhythmogenic cardiovascular disorders such as arrhythmias or cardiac rhythm disturbances, including, but not limited to, atrial fibrillation. AF can occur when GPs become overactive due to loss of inhibition from higher centers (e.g., in elderly people).

[0122] System 100 can be used to control overactive GPs either by stimulating higher centers and their connections, such as vagus nerve stimulation, or simply by ablat- ing the GPs. Thus, device 102, in conjunction with console 104, may detect and identify GPs and further determine sufficient energy levels to therapeutically modulate or treat (i.e., ablate) the GPs for the treatment of AF (i.e., surgically disrupting the origin of the AF-causing signals and interrupting the conduction pathways for such signals) while minimizing and / or preventing collateral damage to surrounding or adjacent non-neural tissue, including blood vessels and bone, as well as non-target neural tissue. Note that other nerve and / or cardiac tissue or other structures known to affect or cause AF, including, but not limited to, pulmonary veins, can be targeted by system 100 (e.g., pulmonary vein isolation in response to the creation of lesions around the PV ostium to prevent triggers from reaching the atrial substrate).

[0123] In addition to treating arrhythmias, system 100 may also be used to treat other cardiovascular-related conditions, particularly those involving the kidneys, which play a significant role in the progression of CHF, as well as chronic renal failure (CRF), end-stage renal disease (ESRD), hypertension (pathologically high blood pressure), and other cardiorenal diseases.

[0124] The functions of the kidneys can be summarized under three broad categories: filtering blood and excreting waste products generated by the body's metabolism; regulating salt, water, electrolytes, and acid-base balance; and secreting hormones to maintain vital organ blood flow. Without proper kidney function, patients will suffer from water retention, reduced urine flow, and the accumulation of waste toxins in the blood and body. These conditions, which result from reduced kidney function or kidney failure (renal dysfunction), are thought to increase the workload of the heart.

[0125] For example, in patients with CHF, renal failure further worsens the heart because fluid accumulation and blood toxins accumulate due to poorly functioning kidneys, further harming the heart. CHF is a condition that occurs when the heart becomes damaged and reduces blood flow to the body's organs. If blood flow is reduced sufficiently, kidney function becomes compromised, leading to fluid retention, abnormal hormone secretion, and increased vascular constriction. These consequences increase the heart's workload, further reducing its capacity to pump blood through the kidneys and circulatory system. This reduced capacity further reduces blood flow to the kidneys. The progressively reduced perfusion of the kidneys is thought to be the primary non-cardiac cause that perpetuates the downward spiral of CHF. Furthermore, fluid overload and associated clinical symptoms resulting from these physiological changes are the primary causes of excess hospitalizations, reduced quality of life, and overwhelming costs to the healthcare system due to CHF.

[0126] End-stage renal disease is another condition that is controlled, at least in part, by renal nerve activity. There has been a dramatic increase in patients with ESRD due to diabetic nephropathy, chronic glomerulonephritis, and uncontrolled hypertension. Chronic renal failure (CRF) slowly progresses to ESRD. CRF represents a critical cycle in the evolution of ESRD. Signs and symptoms of CRF are initially mild but become progressive and irreversible over the course of 2 to 5 years. Although some progress has been made in combating the progression to ESRD and its complications, the clinical benefit of existing interventions remains limited.

[0127] Arterial hypertension is a major health problem worldwide. Treatment-resistant hypertension is defined as the inability to achieve target blood pressure despite the combined use of maximally tolerated doses of three different antihypertensive medications, including diuretics. Treatment-resistant hypertension is associated with significant morbidity and mortality. Patients with treatment-resistant hypertension have significantly increased cardiovascular morbidity and mortality and face an increased risk of myocardial infarction (MI), stroke, and death compared to patients with well-controlled hypertension.

[0128] The autonomic nervous system (ANS) is recognized as a key pathway for control signals involved in regulating bodily functions important for maintaining vascular fluid balance and blood pressure. Through its sensory fibers, the ANS transmits information in the form of signals from the body's biological sensors, such as baroreceptors (which respond to blood pressure and volume) and chemoreceptors (which respond to blood's chemical composition), to the central nervous system. It also transmits command signals from the central nervous system, controlling various innervated components of the vasculature, through its motor fibers.

[0129] It is known from clinical experience and research that increased renal sympathetic nerve activity leads to vasoconstriction of blood vessels supplying the kidney, reduced renal blood flow, reduced water and sodium removal from the body, and increased renin secretion. It is also known that reducing renal sympathetic nerve activity, for example, via denervation, can reverse these processes.

[0130] The renal sympathetic nervous system plays an important role in the pathophysiology of hypertension. The adventitia of the renal artery contains efferent and afferent sympathetic nerves. Renal sympathetic nerve activation via efferent nerves initiates a cascade that results in an increase in blood pressure. Efferent sympathetic outflow leads to vasoconstriction with subsequent reduction in glomerular blood flow, a decrease in glomerular filtration rate, release of renin by juxtaglomerular cells, and subsequent activation of the renin-angiotensin-aldosterone system, leading to increased tubular reabsorption of sodium and water. The decrease in glomerular filtration rate also stimulates additional systemic sympathetic release of catecholamines. As a result, blood pressure increases due to an increase in total blood volume and increased peripheral vascular resistance.

[0131] System 100 can be used for the treatment of cardiorenal diseases, including hypertension, by providing renal neuromodulation and / or denervation. For example, device 102 may be placed at one or more target sites associated with renal nerves and other nerve fibers that contribute to renal nerve function or other neural characteristics. For example, device 102, in conjunction with console 104, may detect, identify, and precisely target renal nerve tissue and subsequently deliver energy at a level or frequency sufficient to therapeutically modulate nerves associated with such renal tissue. Such therapeutic modulation of renal nerves and / or renal tissue is sufficient to completely block or denervate the target nerve structure and / or disrupt renal nerve activity while minimizing and / or preventing collateral damage to surrounding or adjacent non-neural tissue, including blood vessels and bone, as well as non-target nerve tissue.

[0132] It should further be noted that system 100 may be used to determine disease progression. In particular, system 100 may obtain measurements at one or more target sites associated with a given disease, disorder, or the like. Such measurements may be based on active neural parameters (i.e., neuronal firing and activity voltage monitoring) and may be used to identify neurons. Active neural parameters (and therefore behavior) change as the disease progresses, thereby enabling the system to identify such changes and determine the progression of the underlying disease or disorder. Such capabilities are possible based at least in part on the fact that system 100 is configured to monitor passive electrical phenomena (i.e., system 100 determines ohmic conductivity frequencies, which remain consistent while conductivity will differ based on disease or disorder progression).

[0133] Figure 3A is a cutaway lateral view illustrating the anatomy of the lateral sinus wall, and Figure 3B is an enlarged lateral view of the nerves of the lateral sinus wall of Figure 1A. The sphenopalatine foramen (SPF) is an opening or canal defined by the palatine and sphenoid bones through which the sphenopalatine vessels and posterior superior sinus nerves pass into the sinus. More specifically, the orbital and sphenoidal processes of the perpendicular plates of the palatine bones define the sphenopalatine notch, which is transformed into the SPF by articulation with the surface of the body of the sphenoid bone.

[0134] The location of the SPF is highly variable within the posterior region of the lateral sinuses, making it difficult to visually identify. Typically, the SPF is located within the middle meatus (MM). However, anatomical variations also result in the SPF being located within the superior meatus (SM) or at the transition between the superior and middle meatus. In one individual, for example, the inferior border of the SPF has been measured approximately 19 mm above the horizontal plate of the palate (i.e., the inferior margin of the sinus), which is approximately 13 mm above the horizontal plate of the inferior turbinate (IT). The average distance from the inferior margin of the sinus to the SPF is approximately 64.4 mm, resulting in an approach angle from the inferior margin of the sinus to the SPF of approximately 11.4°. However, studies to measure the precise location of the SPF have limited practical application due to the wide variability in its location.

[0135] Anatomical variations in the SPF are expected to correspond to alterations in the autonomic and vascular pathways that traverse into the paranasal sinuses. Generally, the posterior sinus nerve (also called the lateral superior posterior sinus nerve) branches from the pterygopalatine ganglion (PPG), also called the sphenopalatine ganglion, and enters the lateral sinus wall of the paranasal sinus through the SPF. The sphenopalatine artery is thought to pass from the pterygopalatine fossa through the SPF on the lateral sinus wall. The sphenopalatine artery branches into two main branches: the posterolateral sinus branch and the posterior septal branch. The main branch of the posterolateral sinus artery progresses inferiorly into the inferior turbinate IT (e.g., approximately 1.0–1.5 mm from the posterior tip of the inferior turbinate IT), while another branch enters the middle turbinate MT and branches anteriorly and posteriorly.

[0136] In addition to the SPF, studies have shown that over 30% of human patients have one or more accessory foraminasal passages, which also carry arteries and nerves into the paranasal sinuses. Accessory foraminasal passages are typically smaller than the SPF and located below it. For example, there may be one, two, three, or more branches of the posterior sinus artery and nerve extending through the corresponding accessory foraminasal passage. The variability in location, size, and quantity associated with accessory foraminasal passages and the associated branching arteries and nerves that travel through them creates a great deal of uncertainty regarding the location of the vasculature and nerves in the sphenopalatine region. Furthermore, the natural anatomy extending from the SPF often includes deep inferior and / or superior grooves that carry nerve and arterial pathways, making it difficult to identify the arterial and nerve branches. For example, grooves may extend more than 5 mm in length, more than 2 mm in width, and more than 1 mm in depth, thereby creating a sufficiently significant pathway for both arteries and nerves to travel. The variability caused by the grooves and accessory foramina in the sphenopalatine region makes it extremely difficult for the surgeon to identify and access the arteries and nerves (located posterior to the arteries).

[0137] Recent microanatomical dissection of the pterygopalatine fossa (PPF) further supports the highly variable anatomy of the region surrounding the SPF, showing that numerous efferent branches projecting from the pterygopalatine ganglion (PPG) innervate the orbital and sinonasal mucosa via numerous small nerve fiber bundles rather than individual postganglionic autonomic nerves (e.g., the posterior sinus nerve). Studies have shown that at least 87% of humans have microforamina and microbranches within the palatine bone.

[0138] For example, Figure 3C is a frontal view of the left palate illustrating the geometry of the foramina and ramus within the left palate. In Figure 3C, solid areas represent nerves that traverse directly through the palate, and open circles represent nerves associated with distinct foramina; thus, Figure 3C illustrates that the medial portion of the palate may contain at least 25 accessory posterolateral nerves.

[0139] The respiratory portion of the sinonasal mucosa is composed of a ciliated pseudostratified columnar epithelium type with a basement membrane. Sinus secretions (e.g., mucus) are secreted by goblet cells in the submucosal glands and exude from plasma. The sinonasal glands and blood vessels are highly regulated by parasympathetic innervation derived from vidian and other nerves. Parasympathetic (cholinergic) stimulation through acetylcholine and vasoactive intestinal peptide generally results in mucus production. Thus, parasympathetic innervation of the mucosa is primarily responsible for submucosal gland activation / hyperactivation, venous congestion (e.g., nasal congestion), and increased blood flow to the blood vessels lining the nose. Therefore, disruption or modulation of the parasympathetic pathways innervating the mucosa is expected to reduce or eliminate the submucosal gland hyperactivation and vascular congestion that cause symptoms associated with rhinosinusitis and other indications.

[0140] As described hereinabove, postganglionic parasympathetic fibers innervating the sinonasal mucosa (i.e., the superior posterior sinus nerve) were thought to proceed exclusively through the SPF as the sphenopalatine neurovascular bundle. The posterior sinus nerve is a branch of the maxillary nerve that innervates the paranasal sinuses via several smaller internal and external branches that extend through the mucosa of the superior and middle turbinates ST, MT (i.e., the sinus turbinates) and the sinus septum. The nasopalatine nerve is generally the largest of the medial superior posterior sinus nerves and passes anteriorly and inferiorly to the floor of the sinus in the supravomeral groove. From here, the nasopalatine nerve passes through the incisive fossa of the hard palate, communicating with the greater palatine nerve and supplying the mucosa of the hard palate. The superior posterior sinus nerve passes unsynaptically through the pterygopalatine ganglion (PPG) via its ganglionic branches onto the maxillary nerve.

[0141] Based on the understanding that the posterior sinus nerve exclusively crosses the SPF and innervates the sinus mucosa, surgical procedures have been performed to selectively cut the posterior sinus nerve as it exits the SPF. However, as discussed above, the sinus parasympathetic pathway actually innervates the sinus mucosa via multiple small nerve fiber bundles (i.e., the accessory posterolateral nerve) rather than a single branch extending through the SPF, with individual branches projecting from the pterygopalatine ganglion (PPG). These branches may route through multiple fissures, accessory foramina, and microforamina throughout the palate, demonstrating anastomotic loops with both the SPF and other accessory nerves. Therefore, if only the parasympathetic nerve crossing the SPF is severed, nearly all patients (e.g., 90% or more) will retain intact parasympathetic fibers to the posterolateral mucosa, which will result in the persistence of the symptoms that the nerve section is intended to alleviate.

[0142] Thus, embodiments of the present disclosure are configured to therapeutically modulate nerves at precise and focused treatment sites corresponding to the locations of branches extending through fissures, accessory foraminasals, and microforaminasal passages throughout the palatine bone (e.g., target area T shown in FIG. 3B). In certain embodiments, the targeted nerves are postganglionic parasympathetic nerves that travel to innervate the sinonasal mucosa. This selective nerve treatment is also expected to reduce the rate of postoperative sinus crusting and dryness, as it allows the clinician to tailor the degree of anterior denervation through judicious sparing of the orbitonasal branches. Furthermore, embodiments of the present disclosure are also expected to maintain at least some sympathetic tone by sparing a portion of the sympathetic contribution from the deep petrosal nerve and the medial perimaxillary plexus, leading to improved outcomes for sinus obstruction. Additionally, embodiments of the present disclosure are configured to target multiple parasympathetic nerve entry sites into the sinus region (e.g., accessory foraminas, fissures, and microforaminas) and provide complete resection of all anastomotic loops, thereby reducing the rate of long-term reinnervation.

[0143] FIG. 4 is a side view of one embodiment of a handheld device for providing therapeutic neuromodulation consistent with the present disclosure.

[0144] As shown, device 102 includes a multi-section end effector 114 that is transformable between a retracted configuration and an expanded, deployed configuration, a shaft 116 operably associated with end effector 114, and a handle 118 operably associated with shaft 116. Multi-section end effector 114 includes at least a first section 122 and a second section 124 that are spaced apart from one another. First section 122 is generally positioned closer to the distal end of shaft 116 and is therefore sometimes referred to herein as the proximal section 122, while second section 124 is generally positioned farther from the distal end of shaft 116 and is therefore sometimes referred to herein as the distal section 124. Each of the first and second sections 122 and 124 is transformable between a stored configuration, which includes a low-profile delivery state for facilitating intraluminal delivery of the end effector 114 to a treatment site within the sinus region, and a deployed configuration, which includes an expanded state, as shown in FIG. 4 and further illustrated in FIGS. 5A-5F. The handle 118 includes at least a first mechanism 126 for deployment of the multi-section end effector 114, particularly the first and second sections 122, 124, from the stored configuration to the deployed configuration, and a second mechanism 128, separate from the first mechanism 124, for control of energy output by either the first or second sections 122, 124 of the end effector 114, particularly electrodes or other energy elements provided by the first and / or second sections 122, 124. The handheld device 102 may further include an auxiliary line 121, which may provide a fluid connection between, for example, a fluid source and the shaft 116, so that fluid may be provided to the target site via the distal end of the shaft 116. In some embodiments, the auxiliary line 121 may provide a connection between a vacuum source and the shaft 116, so that the device 102 may include suction capabilities (via the distal end of the shaft 116).

[0145] Figures 5A, 5B, 5C, 5D, 5E, and 5F are enlarged views of multi-segment end effector 114 illustrating various views of first and second segments 122, 124 in further detail. Figure 5A is an enlarged perspective view of multi-segment end effector 114. Figure 5B is an exploded perspective view of multi-segment end effector 114. Figures 5C and 5D are enlarged top and side views, respectively, of multi-segment end effector 114. Figure 5E is an enlarged front (proximally facing) view of first segment 122 of multi-segment end effector 114. Figure 5F is an enlarged front (proximally facing) view of second segment 124 of multi-segment end effector 114.

[0146] As shown, first section 122 includes at least a first set of flexible support elements, generally in wire form, arranged in a first configuration, and second section 124 includes a second set of flexible support elements, also in wire form, arranged in a second configuration. The first and second sets of flexible support elements include composite wires having conductive and elastic properties. For example, in some embodiments, the composite wires include a shape-memory material such as Nitinol. The flexible support elements may further include a highly lubricious coating, which may provide desirable electrical insulation properties and a desirable low-friction surface finish. Each of first and second sections 122, 124 is convertible between a retracted configuration and an expanded, deployed configuration such that the first and second sets of flexible support elements are configured to position one or more electrodes (see electrode 136 in FIGS. 5E and 5F ) provided on the respective section in contact with one or more target sites when in the deployed configuration.

[0147] As shown, when in the expanded, deployed configuration, the first set of support elements of the first section 122 includes at least a first pair of struts 130a, 130b, each having a loop (or leaflet) shape and extending in an upward direction, and a second pair of struts 132a, 132b, each having a loop (or leaflet) shape and extending in a downward direction generally opposite to at least the first pair of struts 130a, 130b. Note that the terms “upward” and “downward” are used to describe the orientation of the first and second sections 122, 124 relative to one another. More specifically, the first pair of struts 130a, 130b generally extend at an outward angle in a first direction relative to the longitudinal axis of the multi-section end effector 114 and are spaced apart from one another. Similarly, the second pair of struts 132a, 132b extend at an outward angle in a second direction substantially opposite the first direction relative to the longitudinal axis of the multi-section end effector and are spaced apart from one another.

[0148] The second set of support elements of the second section 124 includes a second set of struts 134(1), 134(2), 134(n) (approximately six struts) each having a loop shape that extends outward and forms an open-ended periphery when in the expanded, deployed configuration. As shown, the open-ended periphery generally resembles a bloomed flower, and each looped strut 134 may generally resemble a petal. Note that the second set of struts 134 may include any number of individual struts and is not limited to six as shown. For example, in some embodiments, the second section 124 may include two, three, four, five, six, seven, eight, nine, ten, or more struts 134.

[0149] The first and second sections 122, 124, specifically the struts 130, 132, and 134, include one or more energy delivery elements, such as multiple electrodes 136. Note that any individual strut may include any number of electrodes 136 and is not limited to one electrode as shown. In the expanded state, the struts 130, 132, and 134 can position any number of electrodes 136 relative to tissue at a target site within the sinonasal region (e.g., adjacent the palate bone below the SPF). The electrodes 136 can apply bipolar or multipolar radio frequency (RF) energy to the target site to therapeutically modulate postganglionic parasympathetic nerves innervating the sinonasal mucosa adjacent to the target site. In various embodiments, the electrodes 136 can be configured to apply pulsed RF energy using a desired duty cycle (e.g., 1 second on / 0.5 seconds off) to regulate temperature rise within the target tissue.

[0150] The first and second sections 122, 124 and associated struts 130, 132, and 134 can be sufficiently stiff to support the electrode 136 and position or press the electrode 136 against tissue at the target site. Additionally, each of the expanded first and second sections 122, 124 can press against surrounding anatomical structures proximate the target site (e.g., nasal turbinates, palate bones, etc.), and the individual struts 130, 132, 134 can at least partially conform to the shape of the adjacent anatomical structures to anchor the end effector 114. Additionally, the expansion and conformability of the struts 130, 132, 134 can facilitate placing the electrode 136 in contact with surrounding tissue at the target site. The electrodes 136 can be made from platinum, iridium, gold, silver, stainless steel, platinum-iridium, cobalt-chromium, iridium oxide, polyethylenedioxythiophene (PEDOT), titanium, titanium nitride, carbon, carbon nanotubes, platinum gray, drawn-filled tubing (DFT) with a silver core, and / or other suitable materials for delivering RF energy to target tissue. In some embodiments, such as that illustrated in Figure 6, the struts may include an outer coating surrounding the conductive wire, with portions of the outer coating selectively absent along the length of the strut, thereby exposing the underlying conductive wire to act as an energy delivery element (i.e., electrode) and / or sensing element, as described in further detail herein.

[0151] In some embodiments, each electrode 136 can be operated independently of the other electrodes 136. For example, each electrode can be individually activated, and the polarity and amplitude of each electrode can be selected by an operator or a control algorithm (e.g., implemented by the controller 107 described previously herein). Selective independent control of the electrodes 136 allows the end effector 114 to deliver RF energy to highly customized regions. For example, select portions of the electrodes 136 can be activated to target nerve fibers in specific regions, while other electrodes 136 remain inactive. In some embodiments, for example, electrodes 136 may be activated across a portion of the second section 124 adjacent to tissue at the target site, and electrodes 136 not proximate the target tissue can remain inactive to avoid applying energy to non-target tissue. Such a configuration facilitates selective therapeutic modulation of nerves on the outer sinus wall within one nostril without applying energy to structures in other portions of the sinus.

[0152] The electrodes 136 are electrically coupled to an RF generator (e.g., generator 106 of FIG. 1 ) via wires (not shown) extending from the electrodes 136 through the shaft 116 to the RF generator. When the electrodes 136 are each independently controlled, each electrode 136 is coupled to a corresponding wire extending through the shaft 116. In other embodiments, multiple electrodes 116 can be controlled together, and thus multiple electrodes 116 can be electrically coupled to the same wire extending through the shaft 116. As previously described, the RF generator and / or components operably coupled thereto (e.g., a control module) can include custom algorithms for controlling activation of the electrodes 136. For example, the RF generator can deliver RF power at approximately 460-480 kHz (+ or -5 kHz) to the electrodes 136, activating the electrodes 136 in a predetermined pattern selected based on the position of the end effector 114 relative to the identified location of the treatment site and / or target nerve. The RF generator provides bipolar low power (10 watts with a maximum setting of 50 watts) RF energy delivery and is further capable of providing multiplexing capabilities (across up to 30 channels).

[0153] Once deployed, the first and second sections 122, 124 contact and conform to the shape of the individual locations, including conforming to and complementing the shape of one or more anatomical structures at the individual locations. Thus, the first and second sections 122, 124 become precisely positioned within the sinus and subsequently deliver precisely focused applications of RF thermal energy to one or more target sites via one or more electrodes 136, thereby therapeutically modulating associated neural structures. More specifically, when in the expanded configuration, the first and second sections 122, 124 have a shape and size that are specifically designed to place portions of the first and second sections 122, 124, and thus the one or more electrodes 136 associated therewith, in contact with target sites within the sinus associated with postganglionic parasympathetic nerve fibers that innervate the sinus mucosa.

[0154] For example, a first set of flexible support elements of first section 122 conforms to and complements the shape of a first anatomical structure at a first location when first section 122 is in the deployed configuration, and a second set of flexible support elements of second section 124 conforms to and complements the shape of a second anatomical structure at a second location when the second section is in the deployed configuration. The first and second anatomical structures may include, but are not limited to, the inferior turbinate, middle turbinate, superior turbinate, inferior meatus, middle meatus, superior meatus, pterygopalatine region, pterygopalatine fossa, sphenopalatine foramen, parasphenopalatine foramen, and sphenopalatine microforamen.

[0155] In some embodiments, the first segment 122 of the multi-segment end effector 114 is configured in an expanded configuration to fit around at least a portion of the middle turbinate in an anterior position relative to the middle turbinate, and the second segment 124 of the multi-segment end effector is configured in an expanded configuration to contact multiple tissue locations within the cavity in a posterior position relative to the middle turbinate.

[0156] For example, a first set of flexible support elements (i.e., struts 130 and 132) of the first section 122 conforms to and complements the shape of the lateral attachment and posterior-inferior edge of the middle turbinate when the first section 122 is in the deployed configuration, and a second set of flexible support elements (i.e., struts 134) of the second section 124 contacts multiple tissue locations within the cavity at a posterior position relative to the lateral attachment and posterior-inferior edge of the middle turbinate when the second section 124 is in the deployed configuration. Thus, when in the deployed configuration, the first and second sections 122, 124 are configured to position one or more associated electrodes 136 at one or more target sites relative to any of multiple tissue locations within the cavity behind the middle turbinate and the middle turbinate. In turn, the electrodes 136 are configured to deliver RF energy at a level sufficient to therapeutically modulate postganglionic parasympathetic nerves that innervate the nasal mucosa in innervation pathways within the patient's sinuses.

[0157] As shown in FIG. 5E, first section 122 has a bilateral geometry. Specifically, first section 122 includes two identical sides, including a first side formed from struts 130a, 132a and a second side formed from struts 130b, 132b. This bilateral geometry allows at least one of the two sides to conform to and accommodate the anatomical structure within the sinus when first section 122 is in an expanded state. For example, when in an expanded state, multiple struts 130a, 132a contact multiple locations along multiple portions of the anatomical structure, and electrodes provided by the struts are configured to emit energy at a level sufficient to create multiple microlesions in the tissue of the anatomical structure that block nerve signals to mucus-producing and / or mucosal hyperemic elements. In particular, struts 130a, 132a conform to and complement the shape of the lateral attachment and posterior inferior border of the middle turbinate when first segment 122 is in the deployed configuration, thereby allowing both sides of the anatomical structure to receive energy from the electrodes. This independence between the first and second side configurations (i.e., right and left) allows first segment 122 to be a truly bilateral device. By providing a bilateral geometry, multi-segment end effector 114 does not require a repeat-use configuration to treat the other side of the anatomical structure, as both sides of the structure are simultaneously occupied due to the bilateral geometry. The resulting microlesion pattern can be repeatable and predictable in both macro-elements (depth, volume, shape parameters, surface area), and can be controlled to establish low / high effects for each, as well as micro-elements (thresholding of effects within the macro-envelope can be controlled), as will be described in further detail herein. The system of the present invention can further establish gradients internally, allowing control over neural effects without extensive effects on other cell bodies, as will be described in more detail herein.

[0158] FIG. 7 is a cross-sectional view of a portion of the shaft 116 of the handheld device taken along line 7-7 of FIG. 4. As shown, the shaft 116 may be constructed from multiple components to have the ability to constrain the end effector 114 in a stored configuration (i.e., a low-profile delivery state) when the end effector 114 is stored within the shaft 116, and to further provide an atraumatic, low-profile, and durable means for delivering the end effector 114 to a target site. The shaft 116 includes a coaxial tube that runs from the handle 118 to the distal end of the shaft 116. The shaft 116 has a low profile that ensures transnasal delivery of therapy. The shaft 116 includes an outer sheath 138 surrounding a hypotube 140, which is further assembled over the electrode wire 129 that surrounds an inner lumen 142. The outer sheath 138 serves as an interface between the anatomy and the device 102. The outer sheath 138 may generally include a low-friction PTFE liner to minimize friction between the outer sheath 138 and the hypotube 140 during deployment and retraction. In particular, the outer sheath 138 may generally include an encapsulating braid along the length of the shaft 116 to provide flexibility while retaining kink resistance and further column and / or tensile strength. For example, the outer sheath 138 may include a soft Pebax material that is atraumatic and allows smooth delivery through the sinus passages. The outer sheath 138 may further include orientation / indicator markings on its exterior surface, generally the distal end, that may provide the operator with a visual indication of the architecture and / or spatial orientation of the first and / or second sections 122, 124 of the end effector 114 to aid in placement and deployment of the end effector 114.

[0159] The hypotube 140 is assembled over the electrode wires, which begin in the handle 118 and progress to the proximal end of the end effector 114. The hypotube 140 generally acts to protect the wires during delivery and is malleable to allow flexibility without kinking, thereby improving trackability. The hypotube 140 provides rigidity, allowing torqueability of the device 102 and ensuring accurate placement of the end effector 114. The hypotube 140 also provides a low-friction outer surface, allowing for low force when the outer sheath 138 moves relative to the hypotube 140 during deployment and retraction or restraint. The shaft 116 may be pre-shaped in such a manner to complement the sinuses. For example, the hypotube 140 may be annealed to create a bending shaft 116 with a preset curve. The hypotube 140 may include, for example, stainless steel tubing that interfaces with a liner within the outer sheath 138 for low-friction movement.

[0160] The inner lumen 142 may generally provide a channel for fluid extraction during a treatment procedure. For example, the inner lumen 142 extends from the distal end of the shaft 116 through the hypotube 140, via a fluid line (line 121 in FIG. 4) to the atmosphere. The inner lumen 142 material is selected to resist the forces of external components acting on it during the procedure.

[0161] 8A is a side view of the handle of handheld 118, and FIG. 8B is a side view of handle 118 illustrating the internal components enclosed therein. Handle 118 generally includes an ergonomically designed grip portion that provides ambidextrous use for both left- and right-handed use, conforms to the anthropometry of the hand, and allows for at least one of an overhand grip style and an underhand grip style during use in a procedure. For example, handle 118 may include specific contours, including recesses 144, 146, and 148, designed to naturally receive one or more of the operator's fingers in either an overhand grip or an underhand grip style and provide a comfortable feel for the operator. For example, in an underhand grip, recess 144 may naturally receive the operator's index finger, recess 146 may naturally receive the operator's middle finger, recess 148 may naturally receive the operator's ring and pinkie fingers that wrap around proximal protrusion 150, and the operator's thumb naturally rests on the upper portion of handle 118 adjacent first feature 126. In an overhand grip, the operator's index finger may naturally rest on the upper portion of handle 118 adjacent first feature 126, while recess 144 may naturally receive the operator's middle finger, recess 146 may naturally receive a portion of the operator's middle and / or ring finger, and recess 148 may naturally receive and rest within the space between the operator's thumb and index finger (sometimes referred to as the purlice).

[0162] As previously described, the handle includes multiple user-operated mechanisms, including at least a first mechanism 126 for deployment of the end effector from a collapsed / retracted configuration to an expanded, deployed configuration, and a second mechanism 128 for control of energy output by the end effector, particularly energy delivery from one or more electrodes. As shown, the user inputs for the first and second mechanisms 126, 128 are positioned a sufficient distance from each other to allow simultaneous, single-handed actuation of both user inputs during a procedure. For example, the user input for the first mechanism 126 is positioned on a top portion of the handle 118 adjacent the grip portion, and the user input for the second mechanism 128 is positioned on a side portion of the handle 118 adjacent the grip portion. Thus, in an underhand grip style, the operator's thumb rests on the upper portion of the handle adjacent the first mechanism 126, and at least their middle finger is positioned adjacent the second mechanism 128, and each of the first and second mechanisms 126, 128 is accessible and can be actuated. In an overhand grip system, the operator's index finger rests on the upper portion of the handle adjacent the first mechanism 126, and at least their thumb is positioned adjacent the second mechanism 128, and each of the first and second mechanisms 126, 128 is accessible and can be actuated. Thus, the handle accommodates various styles of grip and provides a degree of comfort for the surgeon, thereby further improving the performance of the procedure and the overall outcome.

[0163] 8B, various components provided within the handle 118 are illustrated. As shown, the first mechanism 126 may generally include a rack and pinion assembly that provides movement of the end effector between a retracted configuration and a deployed configuration in response to input from a user-operated controller. The rack and pinion assembly generally includes a set of gears 152 for receiving input from the user-operated controller and translating the input into linear motion of a rack member 154 operably associated with the shaft 116 and at least one of the end effectors. The rack and pinion assembly includes a gearing ratio sufficient to balance stroke length and retraction and deployment forces, thereby improving control over deployment of the end effector. As shown, the rack member 154 may be coupled to a portion of the shaft 116 such that movement of the rack member 154, for example, toward the proximal end of the handle 118, causes corresponding movement of the shaft 116 while the end effector remains stationary, thereby exposing the end effector and allowing it to transition from a constrained, stored configuration to an expanded, deployed configuration. Similarly, movement of the rack member 154 toward the distal end of the handle 118 causes corresponding movement of the shaft 116 while the end effector remains stationary, thereby enclosing the end effector within the shaft 116. It should be noted that in other embodiments, the rack member 154 may be coupled directly to a portion of the end effector such that movement of the rack member 154 causes corresponding movement of the end effector while the shaft 116 remains stationary, thereby transitioning the end effector between the stored and deployed configurations.

[0164] The user-operated controller associated with the first mechanism 126 may include a slider mechanism operably associated with a rack and pinion rail assembly. Movement of the slider mechanism in a rearward direction toward the proximal end of the handle transitions the end effector to the deployed configuration, and movement of the slider mechanism in a forward direction toward the distal end of the handle transitions the end effector to the retracted configuration. In other embodiments, the user-operated controller associated with the first mechanism 126 may include a scroll wheel mechanism operably associated with the rack and pinion rail assembly. Rotation of the wheel in a rearward direction toward the proximal end of the handle transitions the end effector to the deployed configuration, and rotation of the wheel in a forward direction toward the distal end of the handle transitions the end effector to the retracted configuration.

[0165] As described above, the end effector of the present invention may further include one or more flexible printed circuit board (PCB) members operatively associated therewith. Thus, as will be explained in further detail herein, the first (proximal) and second (distal) sections of a multi-section end effector essentially serve as a framework onto which separate and individual flexible PCB assemblies are mounted, with energy delivery elements, such as electrodes, provided via the flexible PCB members.

[0166] Thus, the present invention provides an end effector that is highly conformable to anatomical variations within the sinus, allowing an operator to perform precise, minimally invasive, and localized application of energy to one or more target sites within a patient's sinuses, thereby treating the sinus condition. Unlike other surgical procedures, particularly for rhinitis, the device of the present invention is minimally invasive. Once delivered into the sinus, each segment of the end effector can expand to a specific shape and / or size that corresponds to the anatomical structure within the sinus and is associated with the target site. More specifically, each of the first and second segments, when in the deployed configuration, includes a specific geometry to complement the anatomy of a particular location within the sinus. The multiple flexible PCB members attached to the respective first and second sections, once deployed, are capable of correspondingly moving and transitioning to the specific geometry of a given section such that the flexible PCBs of the first and second sections contact and conform to the shape of the respective locations, including conforming to and complementing the shape of one or more anatomical structures at the respective locations.

[0167] In turn, the multiple flexible PCB members of the first and second sections become precisely positioned within the paranasal sinuses and subsequently deliver a precise and focused application of energy via one or more electrodes to targeted tissue at one or more target sites, disrupting multiple nerve signals to mucus-producing and / or mucosal congestion elements and / or causing local hypoxia thereof, thereby reducing mucus production and / or mucosal congestion within the patient's nose and reducing or eliminating one or more symptoms associated with at least one of rhinitis, nasal congestion, and rhinorrhea.

[0168] The use of flexible PCB members provides a greater amount of usable surface area than would otherwise be available with existing end effectors. In particular, the increased surface area allows a greater number of energy delivery elements to be introduced and utilized in a given procedure, further expanding the number of possible patterns of such energy delivery elements. As a result, the contact surface is substantially increased, thereby enabling the end effector of the present invention to deliver treatment to areas within the sinuses that may previously have been inaccessible or untreatable with current treatment devices, or that previously required the surgeon to reposition a given device to reach such areas. Furthermore, the use of flexible PCB members reduces the overall complexity associated with manufacturing the end effector of the present invention. In particular, any given flexible PCB member (including the overall PCB assembly, including multiple PCB members) is constructed separately from the end effector, which includes building the overall electrode design and installation on the given PCB member. Once the PCB assembly is completed, the PCB members are then attached to individual portions of a given section of the end effector as a separate manufacturing step, thereby reducing the complexity otherwise associated with placing electrodes directly on the end effector, which is common practice.

[0169] 9A and 9B are enlarged perspective views of the second (distal) section 124 of the multi-section end effector 114, including a flexible printed circuit board (PCB) assembly operatively associated therewith. FIG. 10 is an enlarged perspective view of a single looped strut or support element 134 of the second (distal) section 124, illustrating an individual PCB member secured to a portion thereof.

[0170] As shown, each of the struts or support elements 134(1)-134(6) of the second (distal) section 134 includes a loop-like or lobular shape. Thus, the struts or support structures 134 may also be referred to herein as leaflets. Each leaflet 134 includes a pair of flexible PCB members 200 affixed to a portion thereof. For example, the first leaflet 134(1) includes a set of flexible PCB members 200(1) and 200(2) coupled thereto, the second leaflet 134(2) includes a set of second flexible PCB members 200(3) and 200(4) coupled thereto, and so on. Thus, in this embodiment, the flexible PCB assembly includes twelve individual flexible PCB members 200, with each of the six leaflets 134 of the distal section 124 including a pair of flexible PCB members 200 attached thereto.

[0171] Each flexible PCB member 200 includes a PCB substrate or base layer made of a flexible material on which one or more electronic components, such as, for example, energy delivery elements (i.e., electrodes) and / or sensors, are provided. As shown, as a result of the flexible substrate material, each flexible PCB member 200 is capable of moving (e.g., bending, twisting, folding, etc.) between various positions in response to movement of the underlying retractable and expandable leaflets 134 attached thereto. As will be described in further detail herein, each flexible PCB member 200 further includes one or more energy delivery elements (e.g., electrodes) provided thereon and configured to deliver energy to tissue associated with one or more target sites within the paranasal sinuses. In this manner, upon deployment of the second (distal) section 124 to the expanded configuration, each of the plurality of flexible PCB members 200 attached to the distal section 124 can correspondingly move and transition to the specific geometry of the lobule 134 such that, once deployed, the flexible PCB members 200 contact and conform to the shape of a particular location, including conforming to and complementing the shape of one or more anatomical structures at the particular location. The plurality of flexible PCB members 200 then become precisely positioned within the sinus and subsequently deliver, via one or more electrodes, a precise and focused application of energy to targeted tissue at one or more target sites, disrupting neural signals to and / or causing local hypoxia of mucus-producing and / or mucosal congestion elements, thereby reducing mucus production and / or mucosal congestion in the patient's nose and reducing or eliminating one or more symptoms associated with at least one of rhinitis, nasal congestion, and rhinorrhea.

[0172] FIG. 11 is an enlarged plan view of one embodiment of a flexible PCB member 300 consistent with the present disclosure. FIG. 12 is a cross-sectional view of a portion of the flexible PCB member 300 taken along line 12-12. In some embodiments, the flexible PCB member 300 may include a pair of conductive tracks or traces 304, 306 sandwiched between first and second layers 302(a) and 302(b) of a flexible substrate. The flexible PCB member 300 is affixed to the corresponding leaflet 134, specifically along the length of a portion of the wire, via an adhesive (e.g., medical-grade epoxy or equivalent) between the second layer 302(b) of the substrate and the wire. A specific portion of the first layer 302(a) of the substrate may be removed, thereby exposing portions of the conductive tracks 304, 306, which may serve as energy-emitting portions of the flexible PCB member 300.

[0173] 13 is an enlarged plan view of another embodiment of a flexible PCB member 400 consistent with the present disclosure. In this embodiment, rather than having exposed portions of electrical tracks serving as energy delivery elements, member 400 includes a set of first electrodes 404(1), 404(2), 404(n) and a set of second electrodes 406(1), 406(2), 406(n) disposed on a flexible substrate 402. As shown, electrodes 404, 406 can be deposited directly on substrate 402 via any known process or technique (e.g., via electrodeposition, ion beam deposition, sputtering, and combinations thereof) or directly mounted using an adhesive such as insulating glue, and then electrically connected to communication paths 405, 407, respectively. Electrodes 404, 406 can be formed from copper, gold, platinum, iridium, stainless steel, and / or other conductive materials or elements. The electrodes 404, 406 can optionally be coated with a surface coating such as, by way of example, iridium oxide, platinum black (Pt black), PEDOT (i.e., poly(3,4-ethylenedioxythiophene)), or carbon nanotubes. Thus, each flexible PCB member may include a thin insulating polymer film having a conductive circuit pattern applied thereto and a thin polymer coating that protects the conductor circuitry. The substrate material may include polyimide or similar polymer material. The electrical communication paths 405, 407 may include traces in or on the substrate, for example, formed from copper, gold, platinum, or silver.

[0174] 14 is a plan view of a flexible PCB assembly 500 consistent with the present disclosure, illustrating various portions of the assembly 500. A given flexible PCB assembly generally includes an elongate body including a distal end defined by a plurality of individual PCB members and a proximal end including a set of corresponding electrical contacts or connectors that communicate with one or more components (e.g., electrodes, sensors, etc.) provided on the given flexible PCB member via an electrical communication path provided therebetween. Each of the plurality of flexible PCB members 200 extends from a transition portion 202 of the elongate body of the PCB assembly.

[0175] The electronic components, including the various components associated therewith (e.g., controller 107, monitoring system 108, evaluation / feedback algorithm 110, interface 112, etc.), are coupled to the console 104 using a corresponding set of electrical contacts or connectors at the proximal end of the PCB assembly (when device 102 is coupled to the console 104). Thus, the electronic components (i.e., electrodes, sensors, or the like) provided on a given flexible PCB member can function in a manner and provide similar benefits as those described above herein. For example, an electrode may be configured to deliver therapeutic energy to targeted tissue within a portion of a paranasal sinus for the treatment of a sinus condition, such as rhinosinusitis, in a manner similar to those described above herein.

[0176] In response to attaching the PCB member to a separate portion of the distal section 134, for example, the elongated body of the PCB assembly is wrapped around the wire 129 (see FIG. 7) and contained within the shaft 116 such that the proximal end, including the electrical connector, extends from the proximal end of the shaft 116 and is available to be coupled to a corresponding connector 156 in the handle 118 (see FIG. 8B).

[0177] FIG. 15 is an enlarged plan view of one embodiment of flexible PCB members 502(1)-502(n) of a flexible PCB assembly 500 consistent with the present disclosure. The substrate of the PCB assembly 500 can be a single or multi-layer flexible PCB layer fabricated as a single workpiece. For example, the substrate 200 can be laser cut from a single piece of flexible PCB material. Thus, manufacturing complexity, time, and cost can be reduced. As shown in FIG. 15, for example, the multiple PCB members 502(1)-502(n) can be formed by laser cutting (or punching) multiple cuts into the distal end of the assembly body that are staggered and include cut or punched reliefs 503 at the ends of every other cut, thereby serving as joints between each set of corresponding pairs of PCB members. In other words, six pairs of PCB members 502 are required for the distal section 124 such that each leaflet 134 of the distal section 124 includes a pair of PCB members affixed thereto. Thus, processing recesses 503 are formed between each of the six pairs of PCB members 502. Transition portions 504 are also formed in the assembly substrate, which effectively gradually transition the PCB members to the smaller width of the elongated body 506 of the PCB assembly.

[0178] 16A and 16B are enlarged plan views of the distal and proximal ends, respectively, of a flexible PCB assembly 500 consistent with the present disclosure, illustrating a PCB member 502 including an array of electrodes 404, 406 and electrical communication paths 405, 407 as shown and described above with respect to the PCB member of FIG. 13. FIG. 16B illustrates a standard connector at the proximal end of the PCB assembly, which includes multiple electrical contacts coupled to the electrodes 404, 406 via communication paths 405, 407.

[0179] 17A and 17B are plan views of another embodiment of a flexible PCB assembly consistent with the present disclosure, illustrating the interleaving of two separate assemblies 600(a) and 600(b) to form a combined assembly of overlapping flexible PCB members 601 from each assembly 600(a), 600(b). FIG. 17A shows the two PCB assemblies separated from each other, illustrating that each assembly includes three pairs of PCB members 600. For example, a first PCB assembly 600(a) includes a first pair 601(1), 601(2), a second pair 601(3), 601(4), and a third pair 601(5), 601(6), while a second PCB assembly 600(b) includes a fourth pair 601(7), 601(8), a fifth pair 601(9), 601(10), and a sixth pair 601(11), 601(12). Figure 17B shows the overlap of the two assemblies 600(a) and 600(b), whereby the paired PCB members of the first assembly 600(a) are offset relative to the paired PCB members of the second assembly 600(b), resulting in a uniform distribution of PCB members when bonded to individual portions of the leaflets. This overlapping, or interleaving, concept allows for relatively simple manufacturing, thereby reducing costs.

[0180] 18A, 18B, and 18C are top and side views, partially in cross section, of one embodiment of a jig assembly 700 used to attach one or more flexible PCB members to individual support elements of the second (distal) section of an end effector. As shown, the jig assembly may include a base 702 and a clamp fixture 704 for applying pressure to a leaflet or portion of the support element, and tensioning pins 706 may be used to apply tension to the leaflet and hold the leaflet in a position flat against the flexible PCB substrate for subsequent adhesive deposition via a dispenser 708. By applying tension to the leaflet (i.e., using dynamic loading), the jig 700 utilizes the elastic properties of the wire, thereby straightening the wire and affixing the flexible PCB member thereto. In response to releasing the tension (once the flexible PCB member is affixed), the leaflet can spring back to its geometric shape.

[0181] 19 is a perspective view of another embodiment of a jig assembly 800 used to attach one or more flexible PCB members to individual support elements of the second (distal) section of the end effector. As shown, the jig assembly 800 includes channels 802 that, when in a deployed configuration, correspond to the geometric shape of the leaflets 134 of the distal section 124. The channels 802 are shaped and / or sized to receive the length of each strut of a given leaflet, such that the jig assembly 802 further includes ports 804 within each channel 802 that are in communication with a vacuum source. Upon approximately aligning the flexible PCB member with the portion of the leaflet retained within the channels 802 (i.e., the length of the strut), an operator may activate the vacuum source, thereby causing a negative pressure to form at each port 804, thereby, in effect, pulling the flexible PCB member toward the leaflet via suction. The flexible PCB member is effectively held in place relative to the leaflets, thereby allowing an operator to affix the flexible PCB member to the leaflets (via adhesive). Each channel 802 may further include flange or hook members 806 to further improve alignment of each leaflet within its respective channel 802. By holding a given leaflet in place while in the deployed configuration and assuming the geometric shape associated with the deployed configuration, minimal manipulation is required when affixing the flexible PCB member thereto. Thus, the flexible PCB member can be manufactured (i.e., cut to a certain size and shape) to naturally align with the leaflets without requiring any specific leaflet manipulation (i.e., deformation of the leaflet struts).

[0182] FIG. 20 is an enlarged side view of the first (proximal) section 122 of the multi-section end effector 114, illustrating the installation of a flexible PCB assembly, comprised of multiple flexible PCB members 900(1)-900(n), onto the various struts or support structures 130 of the first (proximal) section 122. FIG. 21 is an image illustrating a perspective view of the first (proximal) section 122, including a flexible PCB assembly attached to a support element. Similar to that described above with respect to the distal section 124, the proximal section 122 includes struts or support elements 130, 132, which include loop-like or leaflet-like shapes. Thus, the struts or support structures 130, 132 may also be referred to herein as leaflets. Each leaflet 130, 132 includes a pair of flexible PCB members 900 affixed to a portion thereof. For example, first leaflet 130 includes a set of flexible PCB members 900(1) and 900(2) coupled thereto, second leaflet 132 includes a set of second flexible PCB members 900(3) and 900(4) coupled thereto, etc. Flexible PCB member 900 is configured similarly to, and therefore functions in a similar manner as, flexible PCB members 200, 300, 400, 500, and 600 previously described herein.

[0183] Figure 22 is a perspective view of one embodiment of a jig assembly 1000(a) used to attach one or more flexible PCB members to individual support elements of the first (distal) section 122 of the end effector 114. Figure 23 is an enlarged view of the jig assembly 1000(a) of Figure 22. The jig assembly 1000(a) includes a base 1002 and a clamping fixture 1004 for securing the proximal section 122 in place while the flexible PCB member 900 is affixed to a corresponding portion of the proximal section 122. The jig assembly 1000(a) further includes channels 1006 that correspond to the geometric shape of the leaflets 130, 132 of the proximal section 122 when in the deployed configuration. The channels 1006 are shaped and / or sized to receive the length of each strut of a given leaflet, whereby the jig assembly 1000(a) further includes a port 1008 within each channel 1006 that is in communication with a vacuum source. Again, the operator can simply align a given flexible PCB member with a corresponding portion of a leaflet and activate the vacuum source, which pulls the flexible PCB member toward contact with the leaflet, thereby identifying the flexible PCB member for a particular strut of the leaflet for subsequent affixation. The base 1002 of the jig assembly 1000(a) further includes a ridge 110 extending from the base 1002 and having an apex that further encourages flexing of the flexible PCB member during operation of the vacuum source so that the flexible PCB member better conforms to the gap created between the leaflets 130 and 132 when the proximal section 122 is in the deployed configuration. FIG. 24 is an enlarged view of an alternative embodiment of the jig assembly 1000(b) of FIG. 22, which provides additional features.

[0184] It should be noted that the flexible PCB members described herein can be coupled to the support elements of any given end effector via any known wafer bonding technique. For example, a given PCB member can be affixed to the end effector using one or more wafer bonding methods, including, but not limited to, direct bonding, surface activated bonding, plasma activated bonding, anodic bonding, eutectic bonding, glass frit bonding, adhesive bonding, thermocompression bonding, reactive bonding, and transient liquid phase diffusion bonding. As will be appreciated, the wafer bonding technique applied will depend, at least in part, on the given material of the substrate and specifications such as maximum tolerable temperature, mechanical pressure, and / or desired gaseous atmosphere.

[0185] FIG. 25 is an enlarged perspective view of the multi-stage end effector illustrating a flexible PCB member coupled to the loop struts or support elements of each of the first (proximal) and second (distal) sections 122, 124, which, when in the deployed configuration, substantially covers the loop or leaflet shape.

[0186] The use of flexible PCB members provides a greater amount of usable surface area than would otherwise be available with existing end effectors. In particular, the increased surface area allows a greater number of energy delivery elements to be introduced and utilized in a given procedure, further expanding the number of possible patterns of such energy delivery elements. As a result, the contact surface is substantially increased, thereby enabling the end effector of the present invention to deliver treatment to areas within the sinuses that may previously have been inaccessible or untreatable with current treatment devices, or that previously required the surgeon to reposition a given device to reach such areas. Furthermore, the use of flexible PCB members reduces the overall complexity associated with manufacturing the end effector of the present invention. In particular, any given flexible PCB member (including the overall PCB assembly, including multiple PCB members) is constructed separately from the end effector, which includes building the overall electrode design and installation on the given PCB member. Once the PCB assembly is completed, the PCB members are then attached to individual portions of a given section of the end effector as a separate manufacturing step, thereby reducing the complexity otherwise associated with placing electrodes directly on the end effector, which is common practice.

[0187] Thus, the present invention provides an end effector that is highly conformable to anatomical variations within the sinus, allowing an operator to perform precise, minimally invasive, and localized application of energy to one or more target sites within a patient's sinuses, thereby treating the sinus condition. Unlike other surgical procedures, particularly for rhinitis, the device of the present invention is minimally invasive. Once delivered into the sinus, each segment of the end effector can expand to a specific shape and / or size that corresponds to the anatomical structure within the sinus and is associated with the target site. More specifically, each of the first and second segments, when in the deployed configuration, includes a specific geometry to complement the anatomy of a particular location within the sinus. The multiple flexible PCB members attached to the respective first and second sections, once deployed, are capable of correspondingly moving and transitioning to the specific geometry of a given section such that the flexible PCBs of the first and second sections contact and conform to the shape of the respective locations, including conforming to and complementing the shape of one or more anatomical structures at the respective locations.

[0188] In turn, the multiple flexible PCB members of the first and second sections become precisely positioned within the paranasal sinuses and subsequently deliver a precise and focused application of energy via one or more electrodes to targeted tissue at one or more target sites, disrupting multiple nerve signals to mucus-producing and / or mucosal congestion elements and / or causing local hypoxia thereof, thereby reducing mucus production and / or mucosal congestion within the patient's nose and reducing or eliminating one or more symptoms associated with at least one of rhinitis, nasal congestion, and rhinorrhea.

[0189] As described above, the present invention further provides a new and unique end effector that utilizes the benefits of flexible printed circuit boards (PCBs) as well as various manufacturing techniques to provide an improved device for the treatment of rhinosinusitis conditions.

[0190] In particular, the underlying design of the end effector is unique. In a preferred embodiment, the end effector is multi-sectioned and includes a proximal section and a distal section. The proximal and distal sections are constructed from a single, integral workpiece having elastic properties. More specifically, a single piece of shape-memory material, such as Nitinol, may be used to construct one or more portions of the proximal section and the distal section as a whole. For example, in one embodiment, the proximal section is comprised of a pair of interlocking members, while the distal section is comprised of a single member. The pair of interlocking members of the proximal section includes a first member providing a first set of support elements and a second member providing a second set of support elements. Thus, each of the first and second members may be constructed from a single workpiece and subsequently interlocked within one another to form the proximal section, while the distal section comprises a single component (as opposed to an interlocking component) and is thus formed from a single workpiece.

[0191] A single workpiece may initially be in the form of a tube or flat plate and laser cut to form the desired framework of the support elements for the proximal and distal sections. In addition to reducing time, cost, and complexity, the use of laser machining allows manufacturers a greater amount of design freedom, which in turn leads to more tailored geometries and mechanical properties for a given section of the end effector. For example, laser machining allows for greater control of the mechanical properties of the support elements, including tailoring the stiffness of a specific one or a given group of support elements for a given section, thereby enabling tailored tissue contact profiles when a given section is in the expanded, deployed configuration. Furthermore, utilizing raw material workpieces in the form of tubes or flat plates results in support elements with relatively flat surfaces onto which corresponding flexible PCB members are affixed, thereby improving adhesion of the PCB members to tissue within the sinus.

[0192] The present invention provides improved manufacturing techniques for joining PCB members to support elements of a given proximal or distal section. In particular, the present invention contemplates the use of bonding, thermal, and mechanical processes to join PCB members to individual support elements, which may include one or more of adhesive, mechanical, laminating, polymer reflow, induction heating, spot welding, and laser welding processes. For example, in one embodiment, attaching PCB members to individual support elements includes a reflow process in which a flexible PCB member is positioned against the individual support element, one or more polymer layers are then disposed around the flexible PCB member, and heat is then applied, resulting in the one or more polymer layers surrounding the flexible PCB member and subsequently affixing the flexible PCB member to the underlying support element of the end effector section. In another embodiment, a polymer sleeve may be affixed to the support element, thereby providing a substrate onto which a flexible PCB member may be positioned and subsequently attached. It should be noted that the processes of adhering the polymer sleeve and bonding the flexible PCB member to the support element may occur simultaneously through the application of pressure and heat.

[0193] FIG. 26 is a side perspective view of another embodiment of an end effector 1114. The end effector 1114 includes one or more retractable and expandable sections, each comprising a framework of support elements having elastic properties. Each retractable and expandable section further includes one or more flexible printed circuit board (PCB) members provided thereon. The flexible PCB members are comprised of a flexible material capable of moving (e.g., bending, twisting, folding, etc.) between various positions in response to movement of the underlying retractable and expandable sections attached thereto. Each flexible PCB member further includes one or more energy delivery elements (e.g., electrodes) provided thereon and configured to deliver energy to tissue associated with one or more target sites within the sinus. Once delivered within the sinus, the one or more sections expand to a specific shape and / or size that corresponds to the anatomical structure within the sinus and is associated with the target site, and can receive delivery of therapeutic energy for treatment of a condition (i.e., rhinosinusitis or the like). Thus, once deployed, the flexible PCBs of the first and second sections contact and conform to the shape of one or more anatomical structures, including to complement the shape thereof, thereby precisely positioning the electrodes for focused application of energy to targeted tissue at one or more target sites.

[0194] As shown, the end effector 1114 is multi-segmented. It should be noted that the multi-segmented end effector 1114 shares similarities with the end effectors (e.g., 114) previously described herein and illustrated in the corresponding figures, and therefore like reference numerals generally refer to each like part and component.

[0195] As shown, the end effector 1114 generally includes a first section 1122 and a second section 1124 spaced apart from one another. The first section 1122 is positioned closer to the handle and therefore is referred to herein as the “proximal section 1122,” while the second section 1124 is positioned farther from the handle and therefore is referred to herein as the “distal section 1124.” As will be explained in further detail herein, the proximal and distal sections 1122 and 1124 are each constructed from a single, integral workpiece having elastic properties. More specifically, a single piece of shape memory material, such as Nitinol or the like, may be used to construct one or more portions of the proximal section 1122 and also to construct the distal section 1124 in its entirety.

[0196] For example, as shown, the proximal section 1122 is comprised of a pair of interlocking members 1130 and 1132, while the distal section is comprised of a single member. The pair of interlocking members of the proximal section 1122 includes a first member 1130, providing a first set of support elements 1130(a) and 1130(b), and a second member 1132, providing a second set of support members 1132(a)-1132(d). Thus, each of the first member 1130 and the second member 1132 may be constructed from a single workpiece and subsequently interlocked within one another to form the proximal section, as shown in FIG. 26 , while the distal section 1124 comprises a single component (as opposed to an interlocking component) and is therefore formed from a single workpiece.

[0197] 27A and 27B are perspective views of the first interlocking member 1130 of the proximal section 1122, and FIGS. 27C and 27D are side and front-facing perspective views of the second interlocking member 1132 of the proximal section 1122. As shown, the first section 1122 comprises a bilateral geometry. In particular, the first section 1122 includes two identical sides, including a first side (formed from strut 1130(a) of the first interlocking member and struts 1132(a) and 1132(c) of the second interlocking member) and a second side (formed from strut member 1130(b) of the first interlocking member and struts 1132(b) and 1132(d) of the second interlocking member). This bilateral geometry allows at least one of the two sides to conform to and accommodate the anatomical structure within the paranasal sinus when the first section 1122 is in the expanded state. For example, when in the expanded state, the plurality of struts 1130(a)-1130(b) and 1132(a)-1132(d) may contact multiple locations along multiple portions of the anatomical structure, thereby positioning the flexible PCB member provided by the struts to contact a desired target for releasing energy thereto. In particular, one or more of the struts 1130(a)-1130(b) and 1132(a)-1132(d) may conform to and complement the shape of the lateral attachment and posterior inferior border of the middle turbinate when the first section 1122 is in the deployed configuration, thereby allowing both sides of the anatomical structure to receive energy from the flexible PCB member.

[0198] As shown in Figures 27A and 27B, the first interlocking member includes a collar member 1126 from which struts 1130(a) and 1130(b) extend. The collar member is generally annular in shape and configured to connect to a core mandrel or shaft of a treatment device. In the illustrated embodiment, each strut 1130(a) and 1130(b) has an end that is connected to a portion of the collar 1126. In other words, none of the struts 1130(a) or 1130(b) have a free end (i.e., an end that is not connected to anything), in contrast to the plurality of struts 1136 of the distal section 1124, which each have a free distal end. As shown, the struts 1130(a) and 1130(b) extend generally perpendicular to and away from the longitudinal axis of the device. As further shown, each strut 1130(a) and 1130(b) may include one or more articulation sites to improve the flexibility of the strut. The one or more articulation sites may generally include, for example, areas of reduced material. In this example, the areas of reduced material form an S-shaped configuration. The inclusion of articulation sites reduces stiffness, thereby allowing a manufacturer to tailor the movement of a given strut as desired (i.e., direct movement to improve overall tissue contact when the flexible PCB member is placed in position for delivery of treatment energy).

[0199] 27C and 27D , the second interlocking member includes a collar member 1128 from which struts 1132(a)-1132(d) extend. Similar to collar member 1126, collar member 1128 of the second interlocking member can facilitate securing the second interlocking member to a core mandrel or shaft of the device. Additionally, collar 1128 may have an outer diameter slightly smaller than the inner diameter of collar 1126 such that collar 1128 can be concentrically received and secured within collar 1126 of the first interlocking member such that the first and second interlocking members become engaged with one another, thereby creating a fully assembled proximal section 1122.

[0200] In the illustrated embodiment, each strut 1132(a)-1132(d) has an end that is connected to a portion of the collar 1128. In other words, none of the struts 1132(a)-1132(d) have a free end (i.e., an end that is not connected to anything). As shown, struts 1132(a) and 1132(b) generally extend perpendicular to and away from the longitudinal axis of the device in a similar direction as struts 1130(a) and 1130(b), while struts 1132(c) and 1132(d) generally extend perpendicular to and away from the longitudinal axis of the device in the opposite direction as struts 1130(a) and 1130(b) and 1132(a) and 1132(b). As further shown, each strut 1132(a)-1132(d) may include one or more articulation sites that increase the flexibility of the strut.

[0201] As will be described in further detail herein, each of the first and second interlocking members of the proximal section 1122 is constructed from a single workpiece, which may initially be in the form of a tube or flat plate, which can be laser cut to form the desired framework of the struts and collars of the first and second interlocking members.

[0202] FIG. 28 is a perspective view of the distal section 1124. As shown, the distal section 1124 includes a plurality of struts 1136(1), 1136(2)... 1136(n) extending from one or more collar portions 1134(a) and 1134(b). In the illustrated embodiment, the distal section 1124 includes a first collar 1134(a) immediately adjacent the strut and a second collar 1134(b) positioned a length away from the first collar 1134(a) along the length of the body 1138. At least the second collar 1134(b) and the length of the body 1138 are shaped and / or dimensioned to be received within the collars 1126 and 1128, respectively, of the interlocking members of the proximal section 1122 (as shown in FIG. 26). Thus, the second collar 1134(b) may be directly coupled to the core mandrel or shaft of the device, while the body 1138 is of sufficient length to allow the struts 1130 and 1132 of the proximal section 1122 to transition to a fully expanded and deployed configuration unobstructed by the struts 1136 of the distal section 1124.

[0203] As shown, the plurality of struts 1136 of the distal section 1124 include free (i.e., unattached, distal) ends. The struts 1136 are deployable into a coaxial configuration relative to the longitudinal axis of the device. More specifically, when in the deployed configuration, at least a portion of the plurality of individual struts are in a coaxial configuration relative to the longitudinal axis of the device.

[0204] As described above, each of the proximal and distal sections 1122 and 1124 is constructed from a single, unitary workpiece having elastic properties. For example, FIG. 29 is a top view of a single workpiece of material from which the distal section 1124, and specifically the plurality of support elements / struts 1136, are constructed via a laser machining process. The single workpiece may initially be in the form of a tube or flat plate that can be laser cut to form the desired framework of the support elements of the proximal and distal sections. In addition to reducing time, cost, and complexity, the use of laser machining allows a greater amount of design freedom for manufacturers, which in turn leads to more tailored geometries and mechanical properties of a given section of the end effector. For example, laser machining allows for greater control of the mechanical properties of the support elements, including tailoring the stiffness of a specific one or a given group of support elements for a given section (e.g., via the formation of articulating sites), thereby allowing for tailoring the tissue adhesion profile when the given section is in the expanded, deployed configuration. Additionally, utilizing a stock workpiece in the form of a tube or flat plate results in support elements with relatively flat surfaces onto which corresponding flexible PCB members are affixed, thereby improving adhesion of the PCB members to tissue within the sinus.

[0205] 30A and 30B are perspective and side views of the distal section 1124 illustrating the anchoring points 1140 defined on each of the plurality of support elements / struts 1136. As shown, each of the plurality of struts 1136 further includes anchoring points 1140(1) and 1140(2) provided thereon. The anchoring points may be useful in facilitating attachment and alignment of the polymer sleeve and / or flexible PCB member thereto. For example, the anchoring points 1140 may include recesses, holes, notches, grooves, etchings, or the like, as described in further detail herein, to increase surface area, receive pools of adhesive or molten polymer to mechanically secure the polymer sleeve and / or flexible PCB member in place, ensure alignment, and simplify assembly.

[0206] FIG. 31 is a plan view of a single workpiece of material, generally in the form of a flat or generally planar plate, from which the distal section 1124 of FIGS. 30A-30B, specifically the multiple support elements / struts and associated fixation points, are constructed via a laser machining process.

[0207] 32A and 32B are side views of a single workpiece of material, generally in the form of a tube, from which the distal section 1124 of FIGS. 30A-30B, specifically the multiple support elements / struts and associated fixation points, are constructed via a laser machining process.

[0208] 33 is a perspective view of the distal section illustrating various fixation point designs provided on or otherwise associated with one or more of the plurality of struts 1136. As described above, the fixation points can be useful in facilitating attachment and alignment of the polymer sleeve and / or flexible PCB member thereto. For example, different fixation points 1140(1), 1140(2), 1140(3), 1140(4), and 1140(5) can each be useful in reinforcing the bond between the soft polymer material and the strut. As shown, fixation points 1140(1), 1140(3), and 1140(5) each consist of an area of ​​reduced material defined along the length of the strut, which may include fixation point 1140(1) positioned at the distal-most end, fixation point 1140(3) positioned midway along the length along the strut, and fixation point 1140(5) positioned at the proximal-most end of the strut. Fixation points may also include holes or apertures, such as fixation points 1140(2) and 1140(4), which include elongated slots (1140(2)) and discrete holes (1140(4)) defined along the length of a given strut. It should be noted that each of the multiple struts in a given distal section may include the same fixation point design (i.e., all struts have the same fixation point located in the same position), or in some embodiments, individual struts in a given distal section have different fixation point designs or no fixation points at all.

[0209] 34 is a perspective view of the distal section illustrating various anchor point designs provided on or otherwise associated with one or more of the plurality of struts 1130, 1132. As shown, the proximal section 1122 may include a similar anchor point design as the distal section 1124 shown in FIG.

[0210] 35 is a perspective view illustrating another process for coupling the flexible PCB member 200 to corresponding support elements / struts 1136 of the distal section 1124 utilizing fastening points. As described above, the flexible PCB member 200 can be bonded directly to the corresponding struts 1136 via an adhesive. In the illustrated embodiment, the fastening points 1140 generally resemble slots for receiving glue that, once cured, will be embedded within the fastening points 1140 and remain adhered to the flexible PCB member 200, thereby maintaining alignment of the two while ensuring that the PCB member and struts remain joined together.

[0211] FIG. 36 is a perspective view of the distal section 1124 of FIGS. 30A-30B , including an enlarged view illustrating the use of a polymer overlay to join the flexible PCB member to the corresponding support element / strut of the distal section. In the illustrated embodiment, a polymer material may be used as a substrate to attach the flexible PCB member to a given strut. In the illustrated example, via thermal and / or mechanical processes, the polymer may be bonded to a given strut such that the surface of the polymer substrate in contact with the strut deforms and fixation points (shown as slots and holes) act as locations for the formation of a “melt pool” during the polymer reflow process. Such an arrangement creates a joint for the polymer substrate to anchor on at least one side, if not both sides, of the strut, and the polymer material may be welded together within this pool to form a crosslinked plug. More specifically, the formation of melt pools (as a result of the anchoring points (shown as slots and holes)) occurs after processing (i.e., after the polymer reflow process), which in turn promotes polymer cross-linking and bond formation, further reinforcing the adhesion of the polymer to the struts.

[0212] FIG. 37, for example, is a perspective view of distal section 124 of FIGS. 9A-9B illustrating the mounting of a polymer sleeve over the wire support elements of the distal section, with a flexible PCB joined to the polymer sleeve.

[0213] 38 is a perspective view of the distal section of FIG. 28 illustrating the placement of polymer caps or tubing on the free distal ends of the support elements / struts. As shown, in some embodiments, adjacent struts may be joined to one another via the placement of tubing over the respective distal ends of the adjacent struts.

[0214] As described above, the present invention provides improved manufacturing techniques for joining PCB members to support elements of a given proximal or distal section. In particular, the present invention contemplates the use of bonding, thermal, and mechanical processes to join PCB members to individual support elements, which may include one or more of adhesive, mechanical, laminating, polymer reflow, induction heating, spot welding, and laser welding processes. For example, in one embodiment, attaching PCB members to individual support elements includes a reflow process in which a flexible PCB member is positioned against the individual support element, one or more polymer layers are then disposed around the flexible PCB member, and heat is then applied, resulting in the one or more polymer layers surrounding the flexible PCB member and subsequently affixing the flexible PCB member to the underlying support element of the end effector section. In another embodiment, a polymer sleeve may be affixed to the support element, thereby providing a substrate onto which the flexible PCB member may be positioned and subsequently attached. It should be noted that the processes of adhering the polymer sleeve and bonding the flexible PCB member to the support element may occur simultaneously through the application of pressure and heat.

[0215] Figures 39 and 40 are enlarged views illustrating the placement of a polymer sleeve 1142 over the support element / strut of the distal section of Figure 29. Figure 39 illustrates the sleeve extending along the length of the support element / strut, while Figure 40 illustrates discrete portions of the polymer sleeve positioned along the length of the support element / strut at specific locations on the support element / strut (generally forming runners 1144).

[0216] FIG. 41 is a perspective view of the distal section, where each of the plurality of support elements / struts includes a polymer sleeve extending the majority of its length and further includes a flexible PCB member attached thereto.

[0217] FIG. 42 is a perspective view of the distal section, in which a plurality of support elements / struts each include polymer runners 1144(1) and 1144(2) provided at discrete locations along their length, and further includes a flexible PCB member attached to the runners on each support element / strut.

[0218] FIG. 43 is a perspective view of the distal section, where each of the support elements / struts is laser cut and further includes multiple fixation points to which a flexible PCB member may be attached.

[0219] Contains Figures 44A-44D illustrate a reflow process for positioning and affixing the flexible PCB member and polymer tubing to the struts of the proximal section 1122. In particular, a polymer sleeve may be affixed to the struts via a polymer reflow process, thereby providing a substrate onto which the flexible PCB member may be positioned and subsequently attached. As shown in Figures 44A and 44B, one end of each of the struts 1130 and 1132 may be (temporarily) movable away from the collar member, thereby allowing the polymer tubing to be positioned over a given strut at one or more discrete locations along the strut. Upon being positioned at the desired location, heat shrink tubing may then be placed over the polymer tubing (shown in Figure 44C) and heat applied thereon, resulting in the polymer tubing adhering to and surrounding the underlying strut. As described above, one or more anchoring points on a given strut reinforce the bond between the polymer tubing and the underlying strut. Subsequently, a flexible PCB member may then be positioned over the polymer tubing, which now serves as the underlying substrate to which the PCB member will be joined. In particular, as shown in FIG. 44D, the flexible PCB member may be positioned over the polymer tubing and joined thereto via a reflow process, in a manner similar to that used to join the polymer tubing to the strut. In particular, heat shrink tubing may be placed over the flexible PCB member and polymer tubing (shown in FIG. 44D), and heat may be applied thereon, resulting in the flexible PCB member adhering to the underlying polymer tubing.

[0220] 45A and 45B illustrate a reflow process for positioning and affixing the flexible PCB member and polymer tubing to the struts of the distal section 1124. The polymer tubing / sleeve and flexible PCB member are affixed to the plurality of struts 1136 in a similar manner (i.e., reflow process) as described with respect to the reflow process for affixing the polymer tubing / sleeve and flexible PCB member to the struts 1130 and 1132 of the proximal section 1122.

[0221] As described hereinabove, at least one of the proximal and distal sections 1122 and 1124 may further include a cross member coupling one or more of the struts to one another. For example, FIG. 46 is a perspective view of the distal section 1124 in which the support elements / struts 1136 are connected by a cross member in a first configuration, while FIG. 47 is a perspective view of the distal section 1124 in which the support elements / struts are connected by a cross member in a second configuration.

[0222] With reference to Figure 46, pairs of struts 1136 are coupled to each other via cross members 1146 extending therebetween. In particular, the cross members 1146 are arranged in a first configuration relative to the struts, particularly an S-shaped or chevron-shaped pattern, with immediately adjacent support elements / struts connected to each other via corresponding strut members. With reference to Figure 47, the cross members 1146 are arranged in a leapfrog pattern, such that every other one of the plurality of struts 1136 is connected by a corresponding cross member 1146. For example, struts 1136(1) and 1136(3) are coupled to each other via cross member 1146(1), while struts 1136(2) and 1136(4) are coupled to each other via cross member 1146(2).

[0223] The inclusion of cross members 1146 provides significant advantages. For example, the inclusion of cross members, particularly for the distal section 1124, increases the available surface area onto which flexible PCM members may be placed, thereby allowing for more options in terms of electrode number, placement, and overall design. Additionally, cross members may be placed in specific locations to vary radial stiffness as desired, which may further improve tissue adhesion.

[0224] 48A and 48B are side views illustrating the transition of the distal section 1124 to the expanded, deployed configuration and the corresponding movement of a cross member locking mechanism, which couples at least two struts to one another. The cross member locking mechanism is configured to achieve a locked state when the section is in the fully deployed configuration (i.e., when the corresponding strut 1136 reaches a certain point of expansion), thereby preventing retraction of the multiple struts until acted upon by a certain level of force. As shown, the cross member locking mechanism includes a runner 1148 that slides along the length of a shaft 1152 that extends along the longitudinal axis of the device. Multiple extension members 1150 extend from the runner 1148 and are individually coupled to corresponding struts 1136. Movement of the runner 1148 toward the proximal end of the distal section 1124 results in expansion of the struts in an outward direction toward the fully deployed configuration as a result of the force exerted on each strut from the corresponding extension member 1150. Once the runner 1148 reaches a position along the shaft 1152, the cross member locking mechanism achieves a locked position and the struts 1136 remain in the fully deployed configuration. Movement of the runner 1148 along the shaft 1152 toward the distal tip or end cap 1154, located at the distal-most end of the shaft 1152, causes the distal section 1124, and in particular the struts 1136, to transition to the retracted configuration.

[0225] 49A-49C, 50, and 51A-51B illustrate different embodiments of struts of distal section 1124. Similar to the struts illustrated in FIGS. 44A-44C, portions of a given strut illustrated in FIGS. 49A-49C, 50, and 51A-51B may be movable to allow flexible PCB members and polymer tubing to be positioned and affixed thereto for a subsequent polymer reflow process. For example, unlike the struts of FIGS. 44A-44C, in which one end of a given strut is movable relative to (i.e., temporarily separable from) the collar member, each of the struts illustrated in FIGS. 49A-49C, 50, and 51A-51B generally consists of two portions that are temporarily separable from each other at a central portion of the strut.

[0226] In particular, as shown in FIG. 49A , each strut may be comprised of two portions (first and second portions), each having a proximal end directly connected to the collar member and an opposing distal free end extending away from the collar member. The distal free ends of each of the first and second portions of a given strut may further include an attachment feature that allows the free ends to be mechanically coupled to one another, thereby forming a looped strut. For example, as shown in FIGS. 49B and 49C , the free ends of the first and second portions may include a pinhole or other opening that allows the free ends to be aligned and mechanically locked to one another. For example, in some embodiments, a pin, once aligned with one another, may be secured within the pinhole, thereby coupling the free ends to one another. In other embodiments, one free end may include a pin, button, protrusion, or the like, shaped and / or dimensioned to be received within a corresponding opening in the other free end, thereby coupling the free ends to one another. The free ends may have any contemplated shape. For example, the free ends of the first portions of the struts illustrated in Figures 49A-49C may have a distinctive shape, generally in the form of an hourglass. However, the free ends can have any contemplated geometric shape. For example, as illustrated in Figure 50, the free ends of the first portions of the struts are generally linear.

[0227] 51A and 51B, the distal free ends of the first and second portions of the strut are shaped to cooperatively couple to one another via mechanical engagement. In particular, the free end of the first portion may include a flange member, while the free end of the second portion may include a slot therein for receiving the flange member, thereby coupling the free ends to one another.

[0228] As illustrated in Figures 49A-49C, 50, and 51A-51B, the advantage of having a central body separation for a given strut is that it allows for loading of components (e.g., flexible PCB members and polymer tubing) in both directions along a given strut, as opposed to the embodiment illustrated in Figures 44A-44C, in which loading of components onto the strut is performed at a single proximal free end of the strut and completed unidirectionally from there. By having a separation for a given strut in the central portion, and therefore having its proximal end fixed in position relative to the collar member, the attachment of the strut to the collar member is more robust and stronger than the embodiment of Figures 44A-44C. Furthermore, loading of components onto the strut may be easier and faster.

[0229] 49A-49C, 50, and 51A-51B illustrate struts of the distal section, it should be noted that the midbody separation and various attachment features described herein may also be applied to struts of the proximal section.

[0230] 52 and 53 are perspective views of the distal section of FIG. 28 , each illustrating the installation of polymer tubing on the free distal ends of the support elements / struts, and further illustrating the installation of wire or braided tubes over the respective distal ends of adjacent struts to join the adjacent struts to one another and securing the wire or braided tube in place via a polymer reflow process. For example, as illustrated in FIG. 52 , each end of a metal wire may be installed inside a polymer tube installed over an individual strut, and upon undergoing a polymer reflow process, each end of the wire may be secured in place, thereby joining the two adjacent struts. In some embodiments, the wire may be exposed (i.e., the polymer tube does not melt completely across the surface of the wire), while in other embodiments, the entire wire may be enclosed within the polymer. FIG. 53 illustrates the use of a braided tube (e.g., a metal braided tube) used to join two adjacent struts (in a process similar to that described with reference to FIG. 52 ).

[0231] The following provides a detailed description of the various capabilities of the systems and methods of the present invention, including, but not limited to, neuromodulation monitoring, feedback, and mapping capabilities, which in turn enable, for example, detection of anatomical structure and function, neural identification and mapping, and anatomical mapping.

[0232] Neuromodulation monitoring, feedback, and mapping capabilities As previously described, the system 100 includes a console 104 to which the device 102 is connected. The console 104 is configured to provide various functions for the neuromodulation device 102, which may include, but is not limited to, controlling, monitoring, supplying, and / or otherwise supporting operation of the neuromodulation device 102. The console 104 can further be configured to generate energy of a selected form and / or magnitude for delivery to tissue or nerves at a target site via the end effector 114; thus, the console 104 may have different configurations depending on the treatment modality of the device 102. For example, when device 102 is configured for electrode-based, thermal element-based, and / or transducer-based treatment, console 104 includes an energy generator 106 configured to generate RF energy (e.g., monopolar, bipolar, or multipolar RF energy), pulsed electrical energy, microwave energy, optical energy, ultrasound energy (e.g., intraluminally delivered ultrasound and / or HIFU), direct thermal energy, radiation (e.g., infrared, visible, and / or gamma radiation), and / or another suitable type of energy. When device 102 is configured for cryotherapy treatment, console 104 can include a refrigerant reservoir (not shown) and can be configured to supply refrigerant to device 102. Similarly, when device 102 is configured for chemical-based treatment (e.g., drug infusion), console 104 can include a chemical reservoir (not shown) and can be configured to supply one or more chemicals to device 102.

[0233] In some embodiments, the console 104 may include a controller 107 communicatively coupled to the neuromodulation device 102. However, in the embodiments described herein, the controller 107 may generally be carried by or provided within the handle 118 of the neuromodulation device 102. The controller 107 is configured to initiate, terminate, and / or regulate, directly and / or via the console 104, the operation of one or more electrodes provided by the end effector 114. For example, the controller 107 can be configured to execute automatic control algorithms and / or receive control commands from an operator (e.g., a surgeon or other medical professional or clinician). For example, the controller 107 and / or other components of the console 104 (e.g., processor, memory, etc.) may include computer-readable media that carry instructions that, when executed by the controller 107, cause the device 102 to perform a certain function (e.g., apply energy in a specific manner, detect impedance, detect temperature, detect neural location or anatomical structure, perform neural mapping, etc.). Memory may include one or more of a variety of hardware devices for volatile and non-volatile storage, and may include both read-only and writable memory. For example, memory may comprise random access memory (RAM), CPU registers, read-only memory (ROM), and writable non-volatile memory such as flash memory, hard drives, floppy disks, CDs, DVDs, magnetic storage devices, tape drives, device buffers, etc. Memory is not a propagating signal separate from the underlying hardware; memory is therefore non-transitory.

[0234] The console 104 may further be configured to provide feedback to the operator before, during, and / or after a treatment procedure via the mapping / evaluation / feedback algorithm 110. For example, the mapping / evaluation / feedback algorithm 110 can be configured to provide information associated with the location of nerves at the treatment site, the location of other anatomical structures (e.g., blood vessels) at the treatment site, the temperature at the treatment site during monitoring and modulation, and / or the effect of therapeutic neuromodulation on nerves at the treatment site. In an embodiment, the mapping / evaluation / feedback algorithm 110 can include features for confirming the effectiveness of the treatment and / or promoting desired performance of the system 100. For example, the mapping / evaluation / feedback algorithm 110, in conjunction with the controller 107 and the end effector 114, can be configured to monitor neural activity and / or temperature at the treatment site during treatment and automatically stop energy delivery when the neural activity and / or temperature reach a predetermined maximum value (e.g., a threshold reduction in neural activity, a maximum threshold temperature for applying RF energy, or a minimum threshold temperature for providing cryotherapy). In other embodiments, the mapping / evaluation / feedback algorithm 110, in conjunction with the controller 107, can be configured to automatically terminate treatment after a predetermined maximum time, a predetermined maximum impedance or resistance rise of the target tissue (i.e., compared to a baseline impedance measurement), a predetermined maximum impedance of the target tissue, and / or other thresholds for biomarkers associated with autonomous function. Books and other information associated with operation of the system 100 can be communicated to the operator via a display 112 (e.g., monitor, touch screen, user interface, etc.) on the console 104 and / or a separate display (not shown) communicatively coupled to the console 104.

[0235] In various embodiments, the end effector 114 and / or other portions of the system 100 can be configured to detect various bioelectrical parameters of tissue at the target site, and this information can be used by the mapping / evaluation / feedback algorithm 110 to determine the anatomical structures (e.g., tissue type, tissue location, vasculature, bony structures, foramina, sinuses, etc.) at the target site, identify neural structures, differentiate between different types of neural structures, map anatomical and / or neural structures at the target site, and / or identify neuromodulation patterns of the end effector 114 relative to the patient's anatomy. For example, the end effector 114 can be used to detect resistance, complex electrical impedance, dielectric properties, temperature, and / or other properties indicative of the presence of nerve fibers and / or other anatomical structures within the target region. In certain embodiments, the end effector 114, in conjunction with the mapping / evaluation / feedback algorithm 110, can be used to determine the resistance (rather than impedance) of the tissue (i.e., load) to more accurately identify tissue properties. The mapping / evaluation / feedback algorithm 110 can determine the resistance of the tissue by detecting the actual power and current of the load (eg, via the electrodes 136).

[0236] In some embodiments, system 100 provides resistance measurements with a high degree of accuracy and precision, such as measurements down to hundredths of an ohm (e.g., 0.01 Ω) for a range of 1 to 50 Ω. The high degree of resistance detection accuracy provided by system 100 enables detection of sub-microscale structures, including neural structure firing, differences between neural structures and other anatomical structures (e.g., blood vessels), and even different types of neural structures. This information can be analyzed by evaluation / feedback algorithms and / or controller 107 and communicated to an operator via a high-resolution spatial grid and / or other type of display (e.g., on display 112) to identify neural structures and other anatomical structures at the treatment site and / or to indicate predicted areas of neuromodulation based on ablation patterns relative to mapped anatomical structures.

[0237] As described above, in some embodiments, each electrode 136 can be operated independently of the other electrodes 136. For example, each electrode can be individually activated, and the polarity and amplitude of each electrode can be selected by an operator or a control algorithm executed by the controller 107. Selective, independent control of the electrodes 136 allows the end effector 114 to detect information and deliver RF energy to highly customized regions. For example, select portions of the electrodes 136 can be activated to target specific nerve fibers in specific regions, while other electrodes 136 remain inactive. In some embodiments, for example, electrodes 136 may be activated across a portion of the second section 124 adjacent to tissue at the target site, and electrodes 136 not proximate the target tissue may remain inactive to avoid applying energy to non-target tissue. Additionally, electrodes 136 can be individually activated (e.g., via multiplexing) to stimulate or therapeutically modulate certain regions in specific patterns at different times, facilitating detection and / or tailored therapeutic neuromodulation of anatomical parameters across a zone of interest.

[0238] The electrodes 136 can be electrically coupled to the energy generator 106 via wires (not shown) extending from the electrodes 136 through the shaft 116 to the energy generator 106. When the electrodes 136 are each independently controlled, each electrode 136 is coupled to a corresponding wire extending through the shaft 116. This allows each electrode 136 to be independently activated for stimulation or neuromodulation, providing precise ablation patterns, and / or individually detected via the console 104, providing information specific to each electrode 136 for neural or anatomical detection and mapping. In other embodiments, multiple electrodes 136 can be controlled together, and thus multiple electrodes 136 can be electrically coupled to the same wire extending through the shaft 116. The energy generator 16 and / or a component operably coupled thereto (e.g., a control module) can include custom algorithms for controlling the activation of the electrodes 136. For example, the RF generator can deliver RF power at approximately 200-100 W to the electrodes 136, activating the electrodes 136 in a predetermined pattern selected based on the position of the end effector 114 relative to the identified location of the treatment site and / or target nerve. In other embodiments, the energy generator 106 delivers power at lower levels (e.g., less than 1 W, 1-5 W, 5-15 W, 15-50 W, 50-150 W, etc.) and / or higher power levels for stimulation. For example, the energy generator 106 can be configured to deliver stimulation energy pulses of 1-3 W via the electrodes 136 to stimulate specific targets within tissue.

[0239] As previously described, the end effector 114 can further include one or more temperature sensors disposed on the flexible first and second sections 122, 124 and / or other portions of the end effector 114 and electrically coupled to the console 104 via wires (not shown) extending through the shaft 116. In various embodiments, the temperature sensors can be positioned proximate to the electrodes 136 to detect the temperature at the interface between the tissue at the target site and the electrodes 136. In other embodiments, the temperature sensors can penetrate the tissue at the target site (e.g., a penetrating thermocouple) and detect the temperature at a depth within the tissue. The temperature measurements can provide feedback to the operator or system regarding the impact of the therapeutic neuromodulation on the tissue. For example, in certain embodiments, the operator may desire to prevent or reduce damage to tissue (e.g., sinus mucosa) at the treatment site, and thus the temperature sensor can be used to determine whether the tissue temperature reaches a predetermined threshold for irreversible tissue damage. Once a threshold is reached, the application of therapeutic neuromodulation energy can be terminated to allow the tissue to remain intact and avoid significant tissue loss during wound healing. In an embodiment, energy delivery can be terminated automatically based on a mapping / evaluation / feedback algorithm 110 stored on the console 104 that is operably coupled to the temperature sensor.

[0240] In certain embodiments, system 100 can determine the location and / or morphology of neural structures and / or other anatomical structures prior to treatment so that therapeutic neuromodulation can be applied to precise regions containing target neural structures while avoiding adverse effects on non-target structures, such as blood vessels. As described in further detail below, system 100 can detect various bioelectrical parameters within a zone of interest (e.g., within a sinus cavity) to determine the location and morphology of various neural structures (e.g., different types of neural structures, neurotropism, etc.) and / or other tissues (e.g., glandular structures, blood vessels, bony regions, etc.). In some embodiments, system 100 is configured to measure biopotentials. To do so, one or more of electrodes 136 are placed in contact with an epithelial surface in the region of interest (e.g., the treatment site). Electrical stimulation (e.g., constant or pulsed current at one or more frequencies) may be applied to tissue by one or more electrodes 136 at or near the treatment site, and voltage and / or current differences at various different frequencies between various pairs of electrodes 136 of the end effector 114 may be measured to generate a spectral profile or map of detected biopotentials that may be used to identify different types of tissue (e.g., blood vessels, neural structures, and / or other types of tissue) within a region of interest. For example, a current (i.e., direct or alternating current) may be applied to one pair of electrodes 136 adjacent to one another, and the resulting voltage and / or current between the other pair of adjacent electrodes 136 is measured. It should be understood that the current-injecting electrode 136 and the measurement electrode 136 need not be adjacent, and modifying the spacing between the two current-injecting electrodes 136 may affect the depth of the recorded signal. For example, closely spaced current injection electrodes 136 provided recorded signals associated with tissue deeper from the tissue surface than more widely spaced current injection electrodes 136, which provided recorded signals associated with tissue at shallower depths. Recordings from electrode pairs with different spacing may be merged to provide additional information about the depth and identity of anatomical structures.

[0241] Furthermore, complex impedance and / or resistance measurements of tissue in a region of interest can be detected directly from the current-voltage data provided by bioelectrical measurements, while different levels of frequency current can be applied to the tissue (e.g., via the end effector 114). This information can be used to map neural and anatomical structures using frequency differential reconstruction. Applying stimulation at different frequencies will target different stratified layers or cell bodies or groups. At high signal frequencies (e.g., electrical injection or stimulation), for example, the cell membrane of a neural structure does not impede current flow, and current passes directly through the membrane. In this case, the resulting measurements (e.g., impedance, resistance, capacitance, and / or induction) are a function of intracellular and extracellular tissue and fluids. At low signal frequencies, the membrane impedes current flow, providing different defining characteristics of the tissue, such as cell shape or cell spacing. The stimulation frequency can be in the megahertz range, the kilohertz range (e.g., 400-500 kHz, 450-480 kHz, etc.), and / or other frequencies tuned to the characteristics of the tissue being stimulated and the device being used. The detected complex impedance or resistance level from the zone of interest can be displayed to the user (e.g., via the display 112) to visualize a structure based on the stimulation frequency.

[0242] Furthermore, the unique morphology and composition of anatomical structures within the sinus region respond differently to different frequencies, and thus specific frequencies can be selected to identify very specific structures. For example, the morphology or composition of a target structure for anatomical mapping may depend on whether the tissue's cells or other structures are membranous, stratified, and / or annular. In various embodiments, the applied stimulation signal can have a predetermined frequency that is tuned to a specific neural structure, such as the level and / or morphology of myelination. For example, a second axon parasympathetic structure may be more poorly myelinated than a sympathetic or other structure and therefore have a distinct response (e.g., complex impedance, resistance, etc.) to a selected frequency than a sympathetic nerve. Thus, applying signals with different frequencies to a target site can distinguish targeted parasympathetic nerves from non-targeted sensory nerves, thus providing a very specific target site for pre- or post-treatment neural mapping and / or post-treatment neural evaluation. In some embodiments, neural and / or anatomical mapping involves measuring data in a region of interest using at least two different frequencies to identify certain anatomical structures, such that measurements are obtained first based on a response to an injected signal having a first frequency, and then again based on an injected signal having a second frequency different from the first frequency. For example, there are two frequencies at which a hypertrophied (i.e., disease-state characteristic) submucosal target has a different electrical conductivity or permittivity compared to "normal" (i.e., healthy) tissue. Complex conductivity may be determined based on one or more measured physiological parameters (e.g., complex impedance, resistance, dielectric measurements, dipole measurements, etc.) and / or observation of one or more confidently known attributes or signatures. Additionally, system 100 can also apply neuromodulation energy via electrodes 136 at one or more pre-determined frequencies tuned to the target neural structures to provide highly targeted ablation of selected neural structures associated with the frequencies.This highly targeted neuromodulation also reduces the collateral effects of neuromodulation treatment on non-target sites / structures (e.g., blood vessels) because the targeted signal (having a frequency tuned to the target neural structure) will not have the same modulatory effect on the non-target structures.

[0243] Thus, bioelectrical properties such as complex impedance and resistance can be used by the system 100 before, during, and / or after neuromodulation therapy to derive one or more treatment parameters. For example, impedance or resistance measurements may be used to confirm and / or detect contact between one or more electrodes 136 and adjacent tissue before, during, and / or after treatment. Impedance or resistance measurements can also be used to detect whether the electrodes 136 are properly placed relative to the target tissue type by determining whether the recorded spectrum has a shape consistent with the expected tissue type and / or whether consecutively collected spectra were reproducible. In some embodiments, impedance or resistance measurements may be used to identify boundaries for the treatment zone (e.g., specific neural structures to be disturbed), anatomical landmarks, anatomical structures to avoid (e.g., vascular or neural structures that should not be disturbed), and other aspects of delivering energy to tissue.

[0244] The bioelectrical information can be used to generate tissue spectral profiles or maps of different anatomical features at the target site, and the anatomical mapping can be visualized in 3D or 2D images via the display 112 and / or other user interface to guide the selection of a suitable treatment site. This neural and anatomical mapping enables the system 100 to accurately detect and therapeutically modulate postganglionic parasympathetic nerve fibers that innervate the mucosa at multiple nerve entry points into the paranasal sinuses. Furthermore, because there are no clear anatomical markers indicating the location of SPFs, accessory pores, and micropores, neural mapping allows the operator to identify and therapeutically modulate nerves that would otherwise be indistinguishable without complex dissection of the mucosa. In addition, anatomical mapping also allows the clinician to identify certain structures (e.g., certain arteries) that the clinician may wish to avoid during therapeutic neuromodulation. The neural and anatomical bioelectrical properties detected by the system 100 can also be used during and after treatment to determine the real-time effects of therapeutic neuromodulation on the treatment site. For example, the mapping / evaluation / feedback algorithm 110 may also compare detected neural locations and / or activity before and after therapeutic neuromodulation, compare changes in neural activity to predetermined thresholds, and assess whether the application of therapeutic neuromodulation was effective across the treatment site.

[0245] In various embodiments, system 100 can also be configured to map expected therapeutic modulation patterns of electrodes 136 at specific temperatures, and in some embodiments, to take tissue properties into account based on anatomical mapping of the target site. For example, system 100 can be configured to map ablation patterns for specific electrode ablation patterns at a 45° C. isotherm, a 55° C. isotherm, a 65° C. isotherm, and / or other temperatures / ranges (e.g., ranging from 45° C. to 70° C. or higher), depending on the target site and / or structure.

[0246] The system 100 may provide a three-dimensional view of such projected ablation patterns of the electrodes 136 of the end effector 114 via the display 112. The ablation pattern mapping may define the region of influence of each electrode 136 on the surrounding tissue. The region of influence may correspond to the region of tissue that will be exposed to therapeutic modulated energy based on a defined electrode activation pattern (i.e., one, two, three, four, or more electrodes on any given strut of the first and second sections 122, 124). In other words, the ablation pattern mapping can be used to illustrate the ablation pattern of any number of electrodes 136, any geometric shape of electrode layout, and / or any ablation activation protocol (e.g., pulsed activation, multipolar / sequential activation, etc.).

[0247] In some embodiments, the ablation pattern may be configured such that each electrode 136 has a region of influence that surrounds only that individual electrode 136 (i.e., a "dot" pattern). In other embodiments, the ablation pattern may be such that two or more electrodes 136 may link together to form a segmented region of influence that defines a peanut-like or linear shape between the two or more electrodes 136. In further embodiments, the ablation pattern may result in a broader or contiguous pattern in which the region of influence extends along multiple electrodes 136 (e.g., along each strut). In still further embodiments, the ablation pattern may result in different regions of influence depending on the electrode activation pattern, phase angle, target temperature, pulse duration, device configuration, and / or other treatment parameters. A three-dimensional view of the ablation pattern can be output to the display 112 and / or other user interface to allow the clinician to visualize the changing area of ​​influence based on different durations of energy application, different electrode activation sequences (e.g., multiplexing), different pulse sequences, different temperature isotherms, and / or other treatment parameters. This information can be used to determine the appropriate ablation algorithm for the patient's specific anatomy. In other embodiments, the three-dimensional visualization of the area of ​​influence can be used to illustrate the area where the electrodes 136 detect data when measuring bioelectrical properties in relation to anatomical mapping. In this embodiment, the three-dimensional visualization can be used to determine the electrode activation pattern to be used to determine the desired property (e.g., impedance, resistance, etc.) within the desired area. In some embodiments, using dot assessment may be better, while in other embodiments, detecting information from a linear or larger contiguous area may be more appropriate.

[0248] In some embodiments, the mapped ablation pattern is overlaid on the anatomical mapping to identify the types of structures (e.g., neural structures, blood vessels, etc.) that will be therapeutically modulated or otherwise affected by the treatment. An image may be provided to the surgeon, including a digital illustration of the predicted or planned neuromodulation zone in relation to previously identified anatomical structures within the zone of interest. For example, the illustration may show multiple neural structures and identify those neural structures that are expected to be therapeutically modulated based on the predicted neuromodulation zone. The expected therapeutically modulated neural structures may be shaded to distinguish them from unaffected neural structures. In other embodiments, the expected therapeutically modulated neural structures can be distinguished from unaffected neural structures using different colors and / or other indicators. In further embodiments, the expected neuromodulation zone and surrounding anatomical structures (based on the anatomical mapping) are shown in a three-dimensional view and / or include different visualization features (e.g., color coding to identify certain anatomical structures, bioelectrical properties of the target tissue, etc.). The combined predicted ablation pattern and anatomical mapping can be output to the display 112 and / or other user interface to allow the clinician to select an appropriate ablation algorithm for the patient's specific anatomy.

[0249] The images provided by system 100 allow clinicians to visualize ablation patterns prior to treatment and adjust the ablation pattern to target specific anatomical structures while avoiding other structures and preventing collateral effects. For example, clinicians can select treatment patterns to avoid blood vessels, thereby reducing their exposure to therapeutic neuromodulation energy. This reduces the risk of damaging or rupturing blood vessels, thus preventing immediate or occult bleeding. Furthermore, the selective energy application provided by neural mapping reduces collateral effects of therapeutic neuromodulation, such as tissue shedding during wound healing (e.g., 1-3 weeks after ablation), thereby reducing the risk of aspiration associated with neuromodulation procedures.

[0250] System 100 can further be configured to apply neuromodulation energy (via electrodes 136) at a specific frequency that is tuned to the target neural structure, thus specifically targeting the desired neural structure relative to non-target structures. For example, the specific neuromodulation frequency can correspond to a frequency identified as corresponding to the target structure during neural mapping. As explained above, the unique morphology and composition of anatomical structures respond differently to different frequencies. Therefore, frequency-tuned neuromodulation energy tuned to the target structure will not have the same modulating effect on non-target structures. More specifically, applying neuromodulation energy at a target-specific frequency induces ionic agitation within the target neural structure, leading to permeability potential differences and dynamic changes in the neural membrane potential (resulting from differences in intracellular and extracellular fluid pressures) of the target neural structure. This causes degeneration, potentially resulting in vacuolar degeneration and ultimately necrosis in the target neural structure, but is not expected to functionally affect at least some non-target structures (e.g., blood vessels). Thus, system 100 can use neural structure-specific frequencies to both (1) identify the location of a target neural structure for planning an electrode ablation configuration (e.g., electrode geometry and / or activation pattern) that specifically focuses neural modulation on the target neural structure, and (2) apply neuromodulation energy at the characteristic neural frequency to selectively ablate the neural structure in response to the characteristic neural frequency. For example, end effector 114 of system 100 may selectively stimulate and / or modulate parasympathetic fibers, sympathetic fibers, sensory fibers, alpha / beta / delta fibers, C-fibers, anaerobic endings of one or more of the foregoing, insulated fibers (regions with fibers) compared to uninsulated fibers, and / or other neural structures. In some embodiments, system 100 may also selectively target specific cells or cell regions, such as smooth muscle cells, submucosal glands, goblet cells, and stratified cell regions within the sinonasal mucosa, during anatomical mapping and / or therapeutic modulation.Thus, system 100 provides highly selective neuromodulation therapy specific to target neural structures, reducing collateral effects of neuromodulation therapy on non-target structures (eg, blood vessels).

[0251] The present disclosure provides a method for anatomical mapping and therapeutic neuromodulation. The method includes expanding an end effector (i.e., end effector 114) in a zone of interest ("zone of interest"), such as within a portion of a paranasal sinus. For example, end effector 114 can be expanded so that at least some of electrodes 136 are placed in contact with mucosal tissue in the zone of interest. The expanded device can then take bioelectrical measurements via electrodes 136 and / or other sensors to ensure that desired electrodes are in proper contact with tissue in the zone of interest. In some embodiments, for example, system 100 detects impedance and / or resistance across pairs of electrodes 136 to confirm that desired electrodes have proper surface contact with tissue and that all of electrodes 136 are functioning properly.

[0252] The method optionally continues by applying electrical stimulation to the tissue, detecting bioelectrical properties of the tissue, and establishing a baseline norm for the tissue. For example, the method can include measuring resistance, complex impedance, current, voltage, neural firing rate, neuromagnetic fields, muscle activation, and / or other parameters indicative of the location and / or function of neural structures and / or other anatomical structures (e.g., glandular structures, blood vessels, etc.). In some embodiments, the electrode 136 transmits one or more stimulation signals (e.g., pulsed or constant signals) to a zone of interest to stimulate neural activity and initiate action potentials. The stimulation signals can have frequencies tuned to specific target structures (e.g., specific neural structures, glandular structures, blood vessels), allowing for identification of the location of the specific target structures. The specific frequency of the stimulation signal is a function of host permeability; therefore, applying unique frequencies alters tissue attenuation and the depth into the tissue that RF energy will penetrate. For example, lower frequencies typically penetrate deeper into tissue than higher frequencies.

[0253] Pairs of non-stimulating electrodes 136 of the end effector 114 can then detect one or more bioelectric properties of the tissue that occur in response to the stimulus, such as impedance or resistance. For example, an array of electrodes (e.g., electrodes 136) can be selectively paired together in a desired pattern (e.g., multiplexing electrodes 136) to detect bioelectric properties at a desired depth and / or across a desired region to provide a high level of spatial awareness in a zone of interest. In an embodiment, the electrodes 136 can be paired together in a time-sequential manner according to an algorithm (e.g., provided by the mapping / evaluation / feedback algorithm 110). In various embodiments, stimuli can be injected into the tissue at two or more different frequencies, and the resulting bioelectric responses (e.g., action potentials) in response to each of the injected frequencies can be detected via the various pairs of electrodes 136. For example, an anatomical or neural mapping algorithm can cause the end effector 114 to deliver pulsed RF energy at specific frequencies between different pairs of electrodes 136, and the resulting bioelectrical responses can be recorded in chronological order until the desired zone of interest is properly mapped (i.e., "multiplexed"). For example, the end effector 114 can deliver stimulation energy at a first frequency through adjacent pairs of electrodes 136 for a predetermined period of time (e.g., 1-50 milliseconds), and the resulting bioelectrical activity (e.g., resistance) can be detected through one or more other pairs of electrodes 136 (e.g., spaced apart from each other to reach varying depths within the tissue). The end effector 114 can then apply stimulation energy at a second frequency different from the first frequency, and the resulting bioelectrical activity can be detected through the other electrodes. This can continue when the zone of interest is properly mapped at the desired frequency. As described in more detail below, in some embodiments, baseline tissue bioelectrical properties (e.g., neural firing rate) are detected using static detection methods (without injection of a stimulation signal).

[0254] After detecting the baseline bioelectrical properties, the information can be used to map anatomical structures and / or functions in the zone of interest. For example, bioelectrical properties detected by electrodes 136 can be reported via mapping / evaluation / feedback algorithm 110, and the anatomical map can be output to the user via display 112. In some embodiments, complex impedance, dielectric, or resistive measurements can be used to map parasympathetic nerves and, optionally, identify neural structures in overactive pathological conditions. Bioelectrical properties can also be used to map other non-target structures, such as blood vessels, bones, and / or glandular structures, as well as general anatomical structures. Anatomical locations can be provided to the user (e.g., on display 112) as two-dimensional maps (e.g., illustrating relative intensity, illustrating specific locations of potential target structures) and / or as three-dimensional images. This information can be used to differentiate structures at the submicron cellular level and identify very specific target structures (e.g., overactive parasympathetic nerves). The method can also predict ablation patterns for the end effector 114 based on different electrode neuromodulation protocols, optionally overlaying the predicted neuromodulation patterns on the mapped anatomy to indicate to the user the anatomical structures that will be affected by the specific neuromodulation protocol. For example, when the predicted neuromodulation patterns are displayed in relation to the mapped anatomy, a clinician can determine whether target structures will be properly ablated and whether non-target structures (e.g., blood vessels) will be undesirably exposed to the therapeutic neuromodulation energy. Thus, the method can be used to plan neuromodulation treatments, identify very specific target structures, avoid non-target structures, and select electrode neuromodulation protocols.

[0255] Once the target structure has been identified and the desired electrode neuromodulation protocol selected, the method continues by applying therapeutic neuromodulation to the target structure. Neuromodulation energy can be applied to tissue in a highly targeted manner, forming microlesions and selectively modulating the target structure while avoiding non-target vessels and allowing surrounding tissue structures to remain healthy for effective wound healing. In some embodiments, neuromodulation energy can be applied in a pulsed manner, allowing the tissue to cool between modulation pulses to ensure adequate modulation without undesirable effects on non-target tissue. In some embodiments, the neuromodulation algorithm can deliver pulsed RF energy between different pairs of electrodes 136 in chronological order (i.e., "multiplexing") until neuromodulation is predicted to be complete. For example, the end effector 114 can deliver neuromodulation energy (e.g., having a power of 5-10 W (e.g., 7 W, 8 W, 9 W) and a current of approximately 50-100 mA) through adjacent pairs of electrodes 136 until at least one of the following conditions is met: (a) the load resistance reaches a predetermined maximum resistance (e.g., 350 Ω), (b) the thermocouple temperature associated with the electrode pair reaches a predetermined maximum temperature (e.g., 80° C.), or (c) a predetermined period of time has elapsed (e.g., 10 seconds). After the predetermined conditions are met, the end effector 114 can move to the next pair of electrodes in the sequence, and the neuromodulation algorithm can terminate when all of the load resistances of the individual pair of electrodes are at or above a predetermined threshold (e.g., 100 Ω). In various embodiments, RF energy can be applied at a predetermined frequency (e.g., 450-500 kHz) expected to initiate ionic agitation of specific target structures while avoiding functional disruption of non-target structures.

[0256] During and / or after neuromodulation treatment, the method continues by detecting and, optionally, mapping post-treatment bioelectrical properties of the target region. This can be performed in a similar manner as described above. Post-treatment evaluation can indicate whether the target structure (e.g., overactive parasympathetic nerves) has been appropriately modulated or ablated. If the target structure is not appropriately modulated (i.e., neural activity is still detected within the target structure and / or neural activity has not decreased), the method can continue by reapplying therapeutic neuromodulation to the target. If the target structure has been appropriately ablated, the neuromodulation procedure can be completed.

[0257] Detection of anatomical structures and functions Various embodiments of the present technology can include features that measure bioelectrical, dielectric, and / or other properties of tissue at a target site, determine the presence, location, and / or activity of neural structures and other anatomical structures, and optionally map the location of detected neural structures and / or other anatomical structures. For example, the present technology can be used to detect glandular structures and, optionally, their muco-serous and / or other functions. The technology can also be configured to detect vascular structures (e.g., arteries) and, optionally, their arterial function, volumetric pressure, and / or other functions. The mapping features discussed below can be incorporated into system 100 and / or any of the other devices disclosed herein to provide accurate depiction of nerves at a target site.

[0258] Nerve and / or anatomical detection can occur (a) before application of therapeutic neuromodulation energy to determine the presence or location of neural structures and other anatomical structures (e.g., blood vessels, glands, etc.) at the target site and / or record baseline levels of neural activity; (b) during therapeutic neuromodulation to determine the real-time effects of energy application on nerve fibers at the treatment site; and / or (c) after therapeutic neuromodulation to confirm the effectiveness of treatment on the target structure (e.g., nerves, glands, etc.). This allows for the identification of very specific anatomical structures (even down to the microscale or cellular level), thus providing highly targeted neuromodulation. This enhances the efficacy and efficiency of neuromodulation treatment. In addition, anatomical mapping reduces collateral effects of neuromodulation treatment on non-target sites. Thus, targeted neuromodulation prevents damage or rupture of blood vessels (i.e., preventing unwanted bleeding) and collateral damage to tissue, which can be a concern during wound healing (e.g., when damaged tissue sloughs off the sinus wall).

[0259] In certain embodiments, the systems disclosed herein can use bioelectrical measurements such as impedance, resistance, voltage, current density, and / or other parameters (e.g., temperature) to determine anatomy at a target site, particularly nerve, gland, and vascular anatomy. Bioelectrical properties can be detected after delivery of a stimulus (e.g., an electrical stimulus such as RF energy delivered via electrodes 136, i.e., "dynamic" detection) and / or without delivery of a stimulus (i.e., "static" detection).

[0260] Dynamic measurements include various embodiments for exciting neural activation and / or propagation and / or detecting its primary or secondary effects. Such dynamic embodiments involve elevated states of neural activation and propagation and use the dynamic measurements for nerve location and function discrimination relative to adjacent tissue types. For example, a method of dynamic detection can include (1) delivering stimulation energy to a treatment site via a treatment device (e.g., end effector 114) to excite parasympathetic nerves at the treatment site; (2) measuring one or more physiological parameters (e.g., resistance, impedance, etc.) at the treatment site via a measurement / sensing array (e.g., electrodes 136) of the treatment device; (4) identifying the relative presence and location of parasympathetic nerves at the treatment site based on the measurements; and (5) delivering ablation energy to the identified parasympathetic nerves to block the detected parasympathetic nerves.

[0261] Static measurements include various embodiments that correlate with specific natural properties of stratification or cellular composition at or near the treatment site. Static embodiments are directed to the inherent biological and electrical properties of tissue types at or near the treatment site, the stratification or cellular composition at or near the treatment site, and comparing both of the foregoing measurements with tissue types adjacent to the treatment site (not targeted for neuromodulation). This information can be used to identify specific targets (e.g., parasympathetic fibers) and non-targets (e.g., blood vessels, sensory nerves, etc.). For example, a method of static detection may include: (1) determining one or more baseline physiological parameters utilizing a measurement / sensing array (e.g., electrodes 136) of the treatment device prior to ablation; (2) geometrically identifying specific tissue properties within the region of interest based on the measured physiological parameters (e.g., resistance, impedance, etc.); (3) delivering ablation energy via the treatment device to one or more nerves within the region of interest; (4) determining one or more intra-procedural physiological parameters via the measurement / sensing array during delivery of the ablation energy; and (5) determining one or more post-procedural physiological parameters via the measurement / sensing array after delivery of the ablation energy to determine the effectiveness of the delivery of the ablation energy in blocking the nerves that received the ablation energy.

[0262] After initial static and / or dynamic detection of bioelectrical properties, the location of anatomical features can be used to determine where treatment sites should be relative to various anatomical structures for therapeutically effective neuromodulation of the target parasympathetic sinus nerve. The bioelectrical and other physiological properties described herein can be detected via electrodes (e.g., electrodes 136 of end effector 114), and electrode pairings on the device (e.g., end effector 114) can be selected to acquire bioelectrical data in specific zones or regions and at specific depths in the target region. Specific properties detected at or surrounding the target neuromodulation site and associated methods for acquiring these properties are described below. While these specific detection and mapping methods discussed below are described with reference to system 100, the methods can be implemented on other suitable systems and devices that provide anatomical identification, anatomical mapping, and / or neuromodulation therapy.

[0263] Neural Identification and Mapping In many neuromodulation procedures, it is beneficial to identify portions of nerves that fall within the zone and / or region of influence of energy delivered by the neuromodulation device 102 (referred to as the "zone of interest"), as well as the relative three-dimensional location of the neural structures relative to the neuromodulation device 102. Characterizing portions of neural structures within the zone of interest and / or determining the relative location of neural structures within the zone of interest allows a clinician to (1) selectively activate target neural tissue relative to non-target structures (e.g., blood vessels) and (2) subselect specific target neural structures (e.g., parasympathetic nerves) relative to non-target neural structures (e.g., sensory nerves, subgroups of neural structures, neural structures with a certain composition or morphology). Target structures (e.g., parasympathetic nerves) and non-target structures (e.g., blood vessels, sensory nerves, etc.) can be identified based on the specific signatures of the specific structures, defined by the structures' unique morphological compositions and the bioelectrical properties associated with these morphological compositions. For example, unique discrete frequencies can be associated with morphological compositions and therefore used to identify certain structures. Target and non-target structures can also be identified based on the relative bioelectrical activation of the structures to subselect specific neural structures. Furthermore, target and non-target structures can be identified by the different detected responses of the structures to tailored injected stimuli. For example, the systems described herein can detect differences in the magnitude of the structure's response and the response of anatomical structures to different stimuli (e.g., stimuli injected at different frequencies).

[0264] For purposes of this disclosure at least, a nerve can include the following portions, defined based on their individual orientation relative to a zone of interest: terminal nerve structures (e.g., terminal axon structures), branching nerve structures (e.g., branching axon structures), and proceeding nerve structures (e.g., proceeding axon structures). For example, terminal nerve structures enter a zone but do not exit it. Thus, terminal nerve structures are endpoints for nerve signaling and activation. Branching nerve structures are nerves that enter and increase the number of nerves exiting a zone of interest. Branching nerve structures are typically associated with a reduction in the relative geometry of the nerve bundle. Proceeding nerve structures are nerves that enter and exit a zone of interest without substantial change in geometry or value.

[0265] System 100 can be used to detect voltage, current, complex impedance, resistance, permittivity, and / or conductivity associated with a nerve's compound action potential and determine and / or map the relative location and proportion of nerves within a zone of interest. Nerve cross-sectional area ("CSA") is expected to result from increased axonal structure. Each axon is of standard size. Larger nerves (in cross-sectional dimensions) have more axons than nerves with smaller cross-sectional dimensions. The compound action response from larger nerves exceeds that of smaller nerves in both static and dynamic assessments. This is at least in part because the compound action potential is the cumulative action response from each axon. When using static analysis, for example, system 100 can directly measure and map the nerve's impedance or resistance and determine the nerve's location and / or relative size based on the determined impedance or resistance. In dynamic analysis, system 100 can be used to apply stimuli to a zone of interest and detect the dynamic response of nerve structures to the stimuli. Using this information, system 100 can determine and / or map impedance or resistance within a zone of interest, providing information related to nerve location or relative nerve size. Nerve impedance mapping can be illustrated by showing varying complex impedance levels at specific locations at different cross-sectional depths. In other embodiments, nerve impedance or resistance can be mapped into a three-dimensional display.

[0266] Identifying the portions and / or relative locations of nerves within a zone of interest can inform and / or guide the selection of one or more treatment parameters (e.g., electrode ablation patterns, electrode activation plans, etc.) of system 100 to improve treatment efficiency and effectiveness. For example, during nerve monitoring and mapping, system 100 can identify the directionality of a nerve based, at least in part, on the length of neural structures extending along the zone of interest, the relative sizes of the neural structures, and / or the direction of action potentials. This information can then be used by system 100 or a clinician to automatically or manually adjust treatment parameters (e.g., selective electrode activation, bipolar and / or multipolar activation, and / or electrode positioning) to target specific nerves or regions of nerves. For example, system 100 can selectively activate specific electrodes 136, electrode combinations (e.g., asymmetric or symmetric), and / or adjust bipolar or multipolar electrode configurations. In some embodiments, the system 100 can adjust or select waveforms, phase angles, and / or other energy delivery parameters based on neural portion / location mapping and / or neural proportionality mapping. In some embodiments, the structure and / or properties of the electrodes 136 themselves (e.g., material, surface roughening, coating, cross-sectional area, perimeter, penetration, penetration depth, surface mounting, etc.) may be selected based on the neural portion and proportionality mapping.

[0267] In various embodiments, treatment parameters and / or energy delivery parameters can be adjusted to target on-axis or near-axis leading neural structures and / or avoid activation of leading neural structures that are at least approximately perpendicular to the end effector 114. A larger proportion of on-axis or near-axis leading neural structures are affected by the neuromodulation energy provided by the end effector 114 than perpendicular leading neural tissue, which may be exposed and exposed to therapeutic energy only at discrete cross-sections. Thus, the end effector 114 is more likely to affect on-axis or near-axis leading neural structures. Identification of neural structure location (e.g., via complex impedance or resistance mapping) can also enable targeted energy delivery to leading neural structures rather than branching neural structures (typically downstream of leading neural structures), because leading neural structures are closer to the nerve origin and therefore allow additional nerves to be affected by therapeutic neuromodulation, thereby resulting in more efficient treatment and / or greater treatment efficacy. Similarly, identification of neural structure location can be used to target leading and branching neural structures relative to terminal neural structures. In some embodiments, treatment parameters can be adjusted based on the detected neural location to provide a selective regional effect, for example, a clinician can target downstream portions of neural structures only if they wish to affect a local effect on a very specific anatomical structure or location.

[0268] In various embodiments, nerve locations and / or relative positions of nerves can be determined by detecting nerve firing voltage and / or current over time. An array of electrodes 136 can be positioned in contact with tissue in a zone of interest, and the electrodes 136 can measure voltage and / or current associated with nerve firing. This information can optionally be mapped (e.g., on the display 112) to identify the location of nerves in an overactive state (i.e., excessive parasympathetic tone). Rhinitis is at least partially the result of over-firing nerves, as this overactive state promotes excessive mucus production and secretion. Thus, detecting nerve firing rates via voltage and current measurements can be used to identify portions of a region of interest containing excessive parasympathetic function (i.e., nerves in a pathological state). This allows clinicians to identify specific nerves (i.e., nerves with excessive parasympathetic tone) prior to neuromodulation therapy, rather than simply targeting all parasympathetic nerves (including non-pathological parasympathetic nerves), ensuring the correct tissue is treated during neuromodulation therapy. Furthermore, neural firing rates can be detected during or after neuromodulation treatment so that clinicians can monitor changes in neural firing rates and validate treatment effectiveness. For example, documenting a reduction or elimination of neural firing rates after neuromodulation treatment can indicate that the treatment was effective in therapeutically treating excessive / pathological nerves.

[0269] In various embodiments, the system 100 can detect neural activity using dynamic activation by injecting a stimulation signal (i.e., a signal that temporarily activates a nerve) through one or more of the electrodes 136 to induce an action potential, while the other pair of electrodes 136 can detect the bioelectrical nature of the neural response. Detecting neural structures using dynamic activation involves detecting the location of an action potential within a zone of interest by measuring the discharge rate of neurons and associated processes. To generate accurate activity indices, the ability to numerically measure, profile, map, and / or image fast neuronal depolarization is a factor in measuring the discharge rate of neurons and their processes. An action potential causes a rapid increase in voltage across a nerve fiber, and an electrical impulse then spreads along the fiber. As an action potential occurs, the conductivity of the neuronal membrane changes, becoming approximately 40 times greater than when the cell is at rest. During an action potential or nerve depolarization, membrane resistance decreases by approximately 80 times, thereby allowing the applied current to enter the intracellular space. Across a population of neurons, this leads to a net decrease in resistance during consistent neuronal activity, such as a chronic parasympathetic response, because the intracellular space would provide additional conductive ions. The magnitude of such rapid changes has been estimated for peripheral nerve bundles (e.g., containing nerves within the sinuses), with local resistivity changes using near-DC recordings being 2.8–3.7%.

[0270] Detecting neural structures using dynamic activation involves detecting the location of action potentials within a zone of interest by measuring the discharge rate of neurons and associated processes. Each action potential is characterized by a depolarization of the neuronal membrane of up to 110 mV or greater, lasting approximately 2 ms and resulting from the transport of micromolar quantities of ions (e.g., sodium and potassium) across the cell membrane. The complex impedance or resistance change resulting from the neuronal membrane ranges from 1,000 to 25 Ω cm. The introduction of a stimulus and subsequent measurement of the neural response attenuates noise, improves the signal-to-noise ratio, and precisely focuses on the response region, improving neural detection, measurement, and mapping.

[0271] In some embodiments, differences in measurements of physiological parameters (e.g., complex impedance, resistance, voltage) over time can be used to generate neural profiles, spectra, or maps, which can reduce error. For example, the sensitivity of system 100 can be improved because this process provides iterative averaging for stimulation. As a result, the mapping function output can be a unitless ratio between reference and test data at a single frequency and / or multiple frequencies and / or multiple amplitudes. Additional considerations may include multiple frequency evaluation methods, which consequently expand parameter assessments such as resistivity, admittivity, center frequency, or the ratio of extracellular to intracellular resistivity.

[0272] In some embodiments, system 100 may also be configured to indirectly measure structural electrical activity to quantify metabolic recovery processes that accompany action potential activity and act to restore ionic gradients to normal. These are associated with the accumulation of ions in the extracellular space. Indirect measurements of electrical activity can be approximately 1,000 times greater (in millimolar units) and therefore easier to measure, which can enhance the accuracy of the measured electrical properties used to generate neural maps.

[0273] System 100 can perform dynamic neural detection by detecting neural firing voltage and / or current, and optionally, neural firing rate, over time in response to external stimulation of a nerve. For example, an array of electrodes 136 can be positioned in contact with tissue in a zone of interest, one or more of the electrodes 136 can be activated to inject a signal into the tissue that stimulates the nerve, and other electrodes 136 of the electrode array can measure the neural voltage and / or current resulting from neural firing in response to the stimulation. This information can optionally be mapped (e.g., on display 112) to identify the location of the nerve and, in some embodiments, to identify parasympathetic nerves in an overactive state (e.g., indicative of rhinitis or other pathological conditions). Dynamic detection of neural activity (voltage, current, firing rate, etc.) can be performed prior to neuromodulation treatment to detect target nerve locations, select target sites and treatment parameters, and ensure the correct tissue is treated during neuromodulation treatment. Furthermore, dynamic detection of neural activity can be performed during or after neuromodulation treatment to allow clinicians to monitor changes in neural activity and validate treatment effectiveness. For example, recording a reduction or elimination of neural activity after neuromodulation treatment can indicate that the treatment was effective in therapeutically treating excessive / pathological nerves.

[0274] In some embodiments, a stimulation signal can be delivered near the target nerve via one or more penetrating electrodes (e.g., tissue-penetrating microneedles) associated with the end effector 114 and / or a separate device. The stimulation signal generates action potentials that contract smooth muscle cells or other cells. The location and strength of this contraction can be detected via the penetrating electrodes, thereby indicating to the clinician the distance to the nerve and / or the location of the nerve relative to the stimulating needle electrode. In some embodiments, the stimulating electrical signal may have a voltage typically of 1-2 mA or more and a pulse width typically of 100-200 microseconds or more. Shorter pulses of stimulation may provide better discrimination of detected contractions but may require more current. The greater the distance between the electrode and the target nerve, the more energy is required to stimulate. Stimulation and detection of contraction strength and / or location can distinguish whether the electrode is close or far from the nerve and can therefore be used to spatially localize the nerve. In some embodiments, varying pulse widths may be used to measure the distance to the nerve. As the needle gets closer to the nerve, the pulse duration required to elicit a response becomes progressively shorter.

[0275] To identify a nerve through muscle contraction detection, the system 100 can vary the pulse width or amplitude and vary the energy (energy = pulse width × amplitude) of the stimulation delivered to the tissue through the penetrating electrodes. By varying the stimulation energy and monitoring muscle contractions via the penetrating electrodes and / or other types of sensors, the system 100 can estimate the distance to the nerve. If a large amount of energy is required to stimulate the nerve / contract the muscle, the stimulation / penetrating electrodes are far from the nerve. As the stimulation / penetrating electrodes move closer to the nerve, the amount of energy required to induce muscle contraction will decrease. For example, an array of penetrating electrodes can be positioned in tissue in a zone of interest, and one or more of the electrodes can be activated to apply stimulation at different energy levels until a muscle contraction is induced. An iterative process is used to identify the nerve (e.g., via the mapping / evaluation / feedback algorithm 110).

[0276] In some embodiments, the system 100 can measure muscle activation from nerve stimulation (e.g., via electrodes 136) to determine nerve positioning for neural mapping without the use of penetrating electrodes. In this embodiment, the treatment device targets the varicose veins of smooth muscle cells surrounding the submucosal gland and its vascular supply, followed by the compound muscle action potential. This can be used to sum the voltage responses from individual muscle fiber action potentials. The shortest latency is the time from the stimulation artifact to the onset of the response. The corresponding amplitude is measured from baseline to the negative peak and is measured in millivolts (mV). Nerve latency (mean + SD) in adults typically ranges from about 2 to 6 milliseconds, more typically from about 3.4 + 0.8 to about 4.0 + 0.5 milliseconds. Comparative assessments can then be performed, comparing output at each time interval (particularly before and after energy delivery) in addition to group assessments using alternative sinuses. This is expected to provide an accurate assessment of the absolute value of neural function performance, since muscle action / activation can be used to infer neural action / activation, and neural function is an absolute performance measure, while muscle action / activation is a secondary effect or by-product.

[0277] In some embodiments, the system 100 can record the neuromagnetic field outside the nerve and determine the nerve's internal currents without physically disturbing the nerve membrane. Without being bound by theory, the contribution to the magnetic field from currents inside the membrane is two orders of magnitude greater than that from external currents, while the contribution from currents within the membrane is substantially negligible. Electrical stimulation of the nerve coupled with measurements of the magnetic compound action field ("CAF") can produce continuous positions of current dipoles so that the location of conduction changes can be estimated (e.g., via least-squares methods). Visual representations (e.g., via the display 112) using the magnetic contour map can indicate normal or abnormal neural characteristics (e.g., normality can be equated with a characteristic quadrupole pattern propagating along the nerve), and thus indicate diseases, overactive states, and nerves that are suitable targets for neuromodulation.

[0278] During magnetic field detection, an array of electrodes 136 can be positioned in contact with tissue in the zone of interest, and optionally, one or more of the electrodes 136 can be activated to inject electrical stimulation into the tissue. As nerves in the zone of interest fire (either in response to stimulation or in the absence thereof), they generate a magnetic field (e.g., similar to a current-carrying wire), and thus the changing magnetic field indicates the neural firing rate of the nerve. The changing magnetic field caused by neural firing can induce a current that is detected by a nearby sensor wire (e.g., sensor 314) and / or a wire associated with a nearby electrode 136. By measuring this current, the magnetic field strength can be determined. The magnetic field can optionally be mapped (e.g., on the display 112) prior to neuromodulation therapy to detect the location of the nerve, select a target nerve (a nerve with excessive parasympathetic tone), and ensure that the desired nerve is treated during neuromodulation therapy. Additionally, magnetic field information can be used during or after neuromodulation therapy to allow clinicians to monitor changes in neuronal firing rates and validate treatment effectiveness.

[0279] In other embodiments, the neuromagnetic field is measured using a Hall probe or other suitable device, which may be integrated into the end effector 114 and / or part of a separate device delivered to the zone of interest. Alternatively, rather than measuring the voltage in the second wire, the changing magnetic field can be measured in the first wire (i.e., the nerve) using a Hall probe. Current traveling through the Hall probe will be deflected in the semiconductor. This will cause a voltage difference between the top and bottom portions that can be measured. In some aspects of this embodiment, three orthogonal planes are utilized.

[0280] In some embodiments, system 100 can be used to induce an electromotive force ("EMF") in a wire (i.e., a frequency-selective circuit such as a tunable / LC circuit) that is tunable to the resonant frequency of the nerve. In this embodiment, the nerve can be viewed as a current-carrying wire, and firing action potentials are a changing voltage. This causes a changing current, which in turn causes a changing magnetic flux (i.e., a magnetic field perpendicular to the wire). Under Faraday's law of electromagnetic induction / Faraday's principle, the changing magnetic flux induces an EMF (including a changing voltage) in a nearby sensor wire (e.g., integrated into the end effector 114, sensor 314, and / or other structure), and the changing voltage can be measured via system 100.

[0281] In a further embodiment, the sensor wire (e.g., sensor 314) is an inductor, thus providing increased magnetic coupling between the nerve (i.e., the first wire) and the sensor wire (i.e., the second wire), with more turns for increased effectiveness (e.g., V2, rms = V1, rms (N2 / N1)). Due to the changing magnetic field, a voltage is induced in the sensor wire, which can be measured and used to estimate current changes in the nerve. Certain materials can be selected to enhance the efficiency of EMF detection. For example, the sensor wire can include a soft iron core or other high-permeability material for the inductor.

[0282] During induced EMF detection, the end effector 114 and / or other device including the sensor wire can be positioned in contact with tissue in the zone of interest, and optionally, one or more of the electrodes 136 can be activated to inject electrical stimulation into the tissue. As nerves in the zone of interest fire (either in response to stimulation or in its absence), they generate magnetic fields (e.g., similar to current-carrying wires) that induce currents in the sensor wires (e.g., sensors 314). This information can be used to determine nerve location and / or map nerves (e.g., on the display 112) to identify nerve locations and select target nerves (e.g., nerves with excessive parasympathetic tone) prior to neuromodulation treatment, and to ensure that desired nerves are treated during neuromodulation treatment. EMF information can also be used during or after neuromodulation treatment so that clinicians can monitor changes in nerve firing rates and validate treatment effectiveness.

[0283] In some embodiments, system 100 can detect magnetic fields and / or EMFs generated at selected frequencies corresponding to specific types of nerves. The frequency of the detected signal, and by extension, the associated nerve type, can be selected based on an external resonant circuit. Resonance occurs on the external circuit when the frequency of the magnetic field of a specific nerve type matches that of that nerve and the nerve is firing. In this way, system 100 can be used to identify specific subgroups / types of nerves.

[0284] In some embodiments, the system 100 can include a variable capacitor frequency-selective circuit for identifying the location and / or mapping specific nerves (e.g., parasympathetic nerves, sensory nerves, nerve fiber types, nerve subgroups, etc.). The variable capacitor frequency-selective circuit can be defined by other characteristics of the sensor 314 and / or end effector 114. Nerves have different resonant frequencies based on their function and structure. Thus, the system 100 can include a tunable LC circuit with a variable capacitor (C) and / or a variable inductor (L) that can be selectively tuned to the resonant frequency of a desired nerve type. This enables detection of neural activity associated with only the selected nerve type and its associated resonant frequency. Tuning can be achieved by moving the core in and out of the inductor. For example, the tunable LC circuit can tune the inductor by (i) changing the number of coils around the core, (ii) changing the cross-sectional area of ​​the coils around the core, (iii) changing the length of the coils, and / or (iv) changing the magnetic permeability of the core material (e.g., from air to the core material). Systems including such tunable LC circuits provide a high degree of spread and differentiation not only with respect to neural signal activation, but also with respect to the neural types activated and the frequencies at which the neurons are firing.

[0285] Anatomical Mapping In various embodiments, system 100 is further configured to provide minimally invasive anatomical mapping using focused energy current / voltage stimulation from spatially specific sources (e.g., electrodes 136) to induce changes in tissue conductivity in a zone of interest and detect the resulting biopotential and / or bioelectric measurements (e.g., via electrodes 136). Current density within the tissue changes in response to changes in voltage applied by electrodes 136, producing changes in current that can be measured using end effector 114 and / or other parts of system 100. The results of the bioelectric and / or biopotential measurements can be used to predict or estimate relative absorption profilometry and thus tissue structure within the zone of interest. More specifically, each cellular construct has a unique conductivity and absorption profile that may be indicative of a type of tissue or structure, such as bone, soft tissue, blood vessels, nerves, nerve types, and / or certain neural structures. For example, different frequencies attenuate differently through different types of tissue. Thus, by detecting absorbed current within a region, system 100 can determine underlying structures, in some cases down to the sub-microscale, at a cellular level, enabling highly specific target identification and mapping. This highly specific target identification and mapping increases the efficacy and efficiency of neuromodulation therapy while also increasing the safety profile of system 100 and reducing collateral effects on non-target structures.

[0286] To detect electrical and dielectric tissue properties (e.g., resistance, complex impedance, conductivity, and / or permittivity as a function of frequency), electrodes 136 and / or another electrode array are placed on the tissue in a region of interest, and an internal or external source (e.g., generator 106) applies a stimulus (current / voltage) to the tissue. The electrical properties of the tissue between the source and receiver electrodes 136, as well as the current and / or voltage at each receiver electrode 136, are measured. These individual measurements are then converted into an electrical map / image / profile of the tissue and can be visualized for a user on the display 112 to identify anatomical features of interest, in certain embodiments, the location of firing nerves. For example, the anatomical mapping can be provided as a color-coded or grayscale three- or two-dimensional map showing different intensities of certain bioelectrical properties (e.g., resistance, impedance, etc.), or the information can be processed to map actual anatomical structures for the clinician. This information can also be used during neuromodulation therapy to monitor treatment progress on anatomy and after neuromodulation therapy to validate successful treatment. Additionally, anatomical mapping provided by bioelectrical and / or biopotential measurements can be used to track changes to non-target tissue (e.g., blood vessels) resulting from neuromodulation therapy and avoid negative collateral effects. For example, a clinician can identify when therapy begins to ligate blood vessels and / or damaged tissue and modify therapy to avoid bleeding, adverse tissue ablation, and / or other negative collateral effects.

[0287] Furthermore, the threshold frequency of electrical current used to identify a specific target can then be used when applying therapeutic neuromodulation energy. For example, neuromodulation energy can be applied at a specific threshold frequency of electrical current that is specific to the target nerve and differentiates it from other non-targets (e.g., blood vessels, non-target nerves, etc.). Applying ablation energy at a target-specific frequency results in an electric field that generates ionic agitation within the target neural structure, leading to permeation potential differences in the target neural structure. These permeation potential differences cause dynamic changes in neural membrane potential (due to differences in intracellular and extracellular fluid pressures) that lead to vacuolar degeneration and ultimately necrosis of the target neural structure. Using a highly targeted threshold neuromodulation energy to initiate degeneration allows system 100 to deliver therapeutic neuromodulation to a specific target while surrounding blood vessels and other non-target structures remain functional.

[0288] In some embodiments, the system 100 can be further configured to detect bioelectrical properties of tissue by noninvasively recording resistance changes during neuronal depolarization and mapping neural activity with electrical impedance, resistance, bioimpedance, conductivity, permittivity, and / or other bioelectrical measurements. Without being bound by theory, when a nerve depolarizes, cell membrane resistance decreases (e.g., by about 80 times) so that current will pass into the intracellular space through open ion channels. Alternatively, the current will remain in the extracellular space. For noninvasive resistance measurements, the tissue can be stimulated by applying a current below 100 Hz, such as applying a constant current square wave at 1 Hz with an amplitude below 25% (e.g., 10%) of threshold to stimulate neuronal activity, thereby preventing or reducing the possibility that the current will not cross into the intracellular space, or by stimulating at 2 Hz. In either case, resistance and / or complex impedance are recorded by recording voltage changes. A complex impedance or resistance map or area profile can then be generated.

[0289] For impedance / conductivity / permittivity sensing, an electrode 136 and / or another electrode array is placed on the tissue in the region of interest, an internal or external source (e.g., generator 106) applies stimuli to the tissue, and the current and / or voltage at each receiver electrode 136 is measured. Stimuli can be applied at different frequencies to isolate different types of nerves. These individual measurements can then be converted into an electrical map / image / profile of the tissue and visualized for the user on the display 112 to identify anatomical features of interest. Neural mapping can also be used during neuromodulation therapy to select specific nerves for treatment, monitor treatment progress on nerves and other anatomy, and validate successful treatment.

[0290] In some embodiments of the neural and / or anatomical detection methods described above, the procedure may include comparing the intraprocedural physiological parameters to baseline physiological parameters and / or other previously obtained intraprocedural physiological parameters (within the same energy delivery phase). Such comparisons can be used to analyze condition changes in the treated tissue. The intraprocedural physiological parameters may also be compared to one or more pre-determined thresholds, for example, to indicate when to stop delivering treatment energy. In some embodiments of the present technology, the measured baseline, intraprocedural, and post-procedural parameters include complex impedance. In some embodiments of the present technology, the post-procedural physiological parameters are measured after a pre-determined time period to allow dissipation of electric field effects (ionic agitation and / or thermal thresholds), thus facilitating accurate assessment of the treatment.

[0291] In some embodiments, the anatomical mapping methods described above can be used to identify the depth of soft tissue within the sinonasal mucosa. While the mucosa above the turbinates is deep, the depth from the turbinates is relatively shallow. Therefore, identifying tissue depth in this technique also identifies the location and precise targeting location within the sinonasal mucosa. Furthermore, by providing microscale spatial impedance mapping of epithelial tissue as described above, the unique signatures of stratified layers or cell bodies can be used to identify regions of interest. For example, because different regions have larger or smaller populations of specific structures, such as submucosal glands, target regions can be identified through the identification of these structures.

[0292] In some embodiments, system 100 includes additional features that can be used to detect anatomical structures and map anatomical features. For example, system 100 can include an ultrasound probe for identification of neural structures and / or other anatomical structures. Higher frequency ultrasound provides greater resolution but less penetration depth. Thus, the frequency can be varied to achieve appropriate depth and resolution for neural / anatomical identification. Feature identification can rely on spatial pulse length (“SPL”) (wavelength multiplied by the number of cycles in the pulse). Axial resolution (SPL / 2) can also be determined to identify nerves.

[0293] In some embodiments, system 100 can be further configured to deliver stimuli with selective parameters that suppress rather than fully stimulate neural activity. For example, in embodiments in which the intensity-duration relationship for extracellular neural stimulation is selected and controlled, conditions exist in which extracellular currents hyperpolarize cells, resulting in suppression (i.e., a full action potential is not achieved) rather than a stimulatory burst. Both models of ion channels, i.e., HH and RGC, suggest that it is possible to hyperpolarize cells with appropriately designed burst extracellular stimuli rather than prolonged stimulation. This phenomenon can be used to suppress rather than stimulate neural activity during any of the neural detection and / or modulation embodiments described herein.

[0294] In various embodiments, system 100 may apply the anatomical mapping techniques disclosed herein to identify or detect target vasculature and surrounding anatomy before, during, and / or after a procedure.

[0295] Incorporation by Reference References and citations to other documents, such as patents, patent applications, patent publications, journals, books, papers, web content, etc. are made throughout this disclosure. All such documents are incorporated herein by reference in their entirety for all purposes.

[0296] equivalent Various modifications of the invention and many further embodiments thereof, in addition to those shown and described herein, will become apparent to those skilled in the art from the complete contents of this document, including the scientific and patent references cited herein. The subject matter of this specification contains important information, examples, and guidance that can be adapted to the practice of this invention in its various embodiments and equivalents thereof.

[0297] References throughout this specification to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0298] The terms and expressions employed herein are used as terms of description rather than of limitation, and the use of such terms and expressions is not intended to exclude any equivalents of the features (or portions thereof) shown and described, it being recognized that various modifications are possible within the scope of the claims, and therefore the claims are intended to cover all such equivalents.

Claims

[Claim 1] The invention described in this specification.

Images