TITLE: NASAL DILATOR

RELATED APPLICATIONS

[0001] This Application claims priority to pending U.S. provisional patent application Serial No. 61/873,706 entitled "Nasal Dilator", filed September 4, 2013, the entire contents of which are hereby incorporated by reference in their entirety.

[0002] This Application is related to co-pending U.S. utility patent application Serial No. 13/654,401 entitled "Systems and Methods for Controlling Balloon Catheters", filed October 17, 2012 and U.S. utility patent application Serial No. 13/654,409 entitled

"Endoscopic Peripheral" filed October 17, 2012 the entire contents of which are all hereby incorporated by reference in their entirety.

BACKGROUND

[0003] Each year more and more dilation procedures, such as sinus dilation, are performed. For example, balloon sinuplasty, brain surgery, enteroscopy, rhinoscopy,

esophagogastroduodenoscopy, and cosmetic surgery may involve dilation through the nose or other orifice (natural or surgically created) of a patient out of necessity or convenience. In particular, balloon sinuplasty has become more popular in recent years because of enhanced equipment and minimal down time for the patient. Balloon sinuplasty is an endoscopic surgical procedure for the treatment of conditions, such as blocked nasal sinuses. Because the procedure involves the insertion into the nose of balloon catheters, guide wires, and other devices and instruments, such as irrigation catheters, illumination systems, and navigation systems, the costs associated with the required systems may be quite expensive. In addition, the costs are high due to the FDA approval process, manufacturing, and packing limitations. Likewise, insurance reimbursements for the devices, equipment, staff, and hours have decreased placing significant pressure on medical professionals and medical service providers.

[0004] Properly performing dilation procedures and surgeries in the body of the patient require correct positioning of the necessary instrumentation, devices, and equipment.

Some procedures may require multiple medical professionals to ensure proper guidance and placement of the equipment due the size and awkwardness of the equipment. As a result of the complex nature of the systems and procedures and expense of the equipment, some medical professionals may feel uncomfortable performing balloon sinuplasty or similar procedures. In particular, procedures such as balloon sinuplasty have not been very well received and adopted internationally.

SUMMARY OF THE INVENTION

[0005] One embodiment provides a dilator and nasal dilation system. The nasal dilator may include a shaft. A first dilation tip of a first size may extend from a first end of the shaft. A second dilation tip of a second size may extend from a second end of the shaft.

[0006] Another embodiment provides a flexible sinus dilator. The flexible sinus dilator may include an articulable body comprising a shaft with a first end and second opposite end terminating in a dilation tip. The flexible sinus dilator may further include one or more bendable portions along the shaft, at least one bendable portion customizable from a.) a first bent position for a general dilation procedure, b). a second bent position for a sinus-specific dilation procedure having an angle between the dilation tip and the shaft tailored to a patient's sinus. The at least one bendable portion may comprise a material modulus to maintain the angle of the dilation tip in the second bent position during the sinus-specific dilation procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Illustrative embodiments of the present invention are described in detail below with reference to the attached drawing figures, which are incorporated by reference herein and wherein:

[0008] FIG. 1A is a schematic, side view of a dilator in accordance with an illustrative embodiment;

[0009] FIG. IB is a schematic, front view of the nasal dilator of FIG. 1 A;

[0010] FIG. 2A is a schematic, side view of a dilator in accordance with an illustrative embodiment;

[0011] FIG. 2B is a schematic, front view of the nasal dilator of FIG. 2A;

[0012] FIG. 3A is a schematic, side view of a nasal dilator in accordance with an illustrative embodiment;

[0013] FIG. 3B is a schematic, front view of the nasal dilator of FIG. 3A; [0014] FIG. 3C is a schematic, side view of nasal dilators in accordance with illustrative embodiments;

[0015] FIG. 4 is a schematic, side view of nasal dilators in accordance with illustrative embodiments;

[0016] FIGs. 5A-7C are schematic, plan views of dilation tips in accordance with illustrative embodiments;

[0017] FIG. 8A is a schematic, side view of a nasal dilator in accordance with an illustrative embodiment;

[0018] FIG 8B is a schematic, front view of the nasal dilator of FIG. 8A;

[0019] FIG. 9A is a schematic, side view of a nasal dilator in accordance with an illustrative embodiment;

[0020] FIG 9B is a schematic, front view of the nasal dilator of FIG. 9A;

[0021] FIGs. 10A-12C are pictorial representations of dilators in accordance with illustrative embodiments;

[0022] FIGs. 13A-13F are pictorial representations of dilators in accordance with illustrative embodiments;

[0023] FIGs. 14A-14C are pictorial representations of dilators in accordance with illustrative embodiments;

[0024] FIG. 15 is a pictorial representation of a dilator in accordance with an illustrative embodiment;

[0025] FIG. 16 is a pictorial representation of another dilator in accordance with an illustrative embodiment;

[0026] FIGs. 17A-17E are pictorial representations of dilation tips in accordance with illustrative embodiments;

[0027] FIG. 18 is a flowchart of a process for utilizing a sinus dilator in accordance with an illustrative embodiment; and

[0028] FIG. 19 is a pictorial presentation of another dilator in accordance with an illustrative embodiment. DETAILED DESCRIPTION OF THE DRAWINGS

[0029] Illustrative embodiments provide a dilation system, method, and dilation devices for performing dilation. The various systems, devices, and tools with their numerous features and configurations are referred to herein as a "dilator" or "dilators." In one embodiment, the dilators may be utilized for sinus dilation of the frontal, maxillary, sphenoid, and ethmoid sinuses and are referred to as nasal dilators. In other embodiments, the dilators may also be utilized for other dilation procedures, such as nasal opening, choannal atresia, rectal narrowing, or dilation in any number of orifices, organs, tissues, muscles, arteries, or surgically created openings. References to sinus dilation procedures are synonymous with the different types of internal or external medical procedures that may be performed utilizing the various embodiments.

[0030] The dilators may be rigid, semi-rigid, or flexible (e.g., bendable, malleable, etc.). For example, the sinus dilator may be bent by hand or utilizing a tool to customize the shape, configuration, relative angle of one portion to another, and entry angle of the dilation tip(s) of the sinus dilator.

[0031] Likewise, the dilators may be configured for one-time usage or may be utilized repeatedly. For example, the dilators may be configured to be cleaned utilizing any number of sterilization and cleaning devices, systems, or processes. In one embodiment, the dilators are formed from medical or surgical grade metals, plastic, polymers, or other similar materials. For example, surgical metals utilized to form all or portions of the dilators may include stainless steel (e.g., austenitic 316, martensitic 440 and 420), titanium alloys (e.g., Ti6A14V), Tecason, Tecapeek, Tecanyl, Tecatron, Tecapro, Tecaform, Tecanat, Tecafine, Tecadur, Tecatec, Tecapei, and other like plastics or having similar material properties. The dilators may also be configured to have antimicrobial, antibacteria, clotting, or other properties or to disperse one or more medications or materials throughout the surface or defined openings of the dilators as needed.

[0032] In one embodiment, the dilators may include a dilation head or tip configured to enter and fit one or more of the sinuses. For example, the dilation heads may include a rounded, angled, or tapered shape for performing dilation of the sinus or orifice without damaging tissues or otherwise injuring or causing excessive pain to the patient. The dilation heads may also have any number of other shapes and configurations suitable for dilation. [0033] In one embodiment, the diameter of the dilation heads may vary between 1 mm - 6 mm or more or less as needed with the 2 mm - 5 mm being sized for most human patients. Dilation of the sinuses to between 2 mm to 5 mm is desirable for most patients. The dilators may also be specially configured and sized for children (e.g., infants, toddlers, adolescents, etc.), adults, animals, and other orifices or applications. In one embodiment, the dilators may have a dilation tip with different angles, slopes, contours, geometries, and shapes that are configured to impinge upon, make contact with and move, expand or enlarge the sinus pathways to perform dilation. For example, the medical professional may manipulate the dilation systems and devices to position the tip of the dilation system within the sinus as well as advance the tip into the sinus pathways to perform the dilation.

[0034] In one embodiment, the dilators may be semi-bendable for shaping the dilator for the specific geometry and positioning of the sinuses in the nose of a user/patient. For example, the medical professional may bend, mold and/or shape the dilator before using it on the user/patient. The dilator may be bent by hand or utilizing a tool to achieve a desired angle or configuration. In another embodiment, all or portions of the nasal dilator may be three dimensionally printed.

[0035] In another embodiment, the dilator may include an attachable or removable head. The dilation head (which may be extended to include a neck and portion of a handle) is the portion of the dilator that may be inserted within the user to perform dilation. The removable head may allow a medical professional to maintain sterility. For example, a disposable head retrieved from a sterile package may be connected to a reusable handle for performing the dilation procedure after which the disposable head is disposed of. In addition, by disposing of only the removable head, costs and waste may be decreased significantly and potential insurance reimbursements for the dilator may be kept at reasonable amounts. In other embodiments, the entire dilator may be disposable. In still other embodiments, the entire dilator or components thereof may be sterilizable for reuse.

[0036] The dilator may include connectors at ends of a shaft or handle for connecting a first and second dilation head and a first end and second end of the dilator, respectively. In another embodiment, a first connector may be utilized to connect a first dilation tip with a lumen at the first end and suction, irrigation, camera, or light through the second connector at the second end. [0037] The dilator may also include one or more external rounded grooves, channels, ducts (internal or external), or dimples providing an area/space for controlling fluid flow, potentially reducing suction within the body of the user, communicating medicine (e.g. dip the dilator in a medication before performing the procedure or employ a material configured to excrete, leach or dose a like medicinal constituent), or enhancing the ease with which the dilator may be introduced into the sinus. For example, the outer surface of the dilation tip that enters the body of the patient that may be dipped in medication before the dilation procedure is performed to apply the medication to the affected areas during dilation. Other possibilities for performing like functions include using, for example, one or more geometries, materials or combination of both to control interaction of the boundary surface (e.g., surface tension) with the surrounding tissue (e.g., surface tension parameters to promote or discourage fluid wicking, fluid flow and surface repulsion (hydrophobicity).

[0038] In one embodiment, the dilators include markings or indicators that act as reference points for the medical professional. The markings may be lines, text, or symbols that indicate the approximate depth that the dilation system or device should be inserted into the nose or body of the user. The markings may be configured to be incandescent or glow in the dark to increase visibility to the user in a number of conditions, environments, and light conditions. For example, during sinus procedures, the markings may prevent a medical professional from reaching the brain of the patient with the dilator.

[0039] In one embodiment, the dilator may include integrated or removable dual heads (ends) with each of the heads configured for separate sinuses or dilation procedures. The dual heads may further increase the flexibility and ease of use of the dilators for the medical professionals. For example, the dual heads may be of different sizes (e.g. 2 mm and 4mm, or 3 mm and 5 mm) to perform dilation in stages to more effectively perform dilation without injuring the patient. The dilators herein described may utilize any number of handles or grips or mechanisms for moving and manipulating the dilator to best help the user during the dilation procedure.

[0040] In one embodiment, the dilator may include one or more internal channels, lumens, or tubes for applying suction or irrigation. For example, the dilator may include a hollow core for performing suction or irrigation (or both) during a dilation procedure. In addition to suction, and possibly separately, the one or more channels may be configured with a surface property (e.g. resulting from geometric or material properties) to wick, repulse or draw, or otherwise move fluids in one or more directions. Being able to perform suction during the procedure may be useful to prevent unwanted mucus, blood, and other build up generally and/or at certain locations of the dilator during the procedure. The channels (e.g. internal, as well as external) may also be utilized to receive a fiber optic camera, wireless camera, or light source for utilization at the end of the dilator. The hollow core may also be utilized to deliver irrigation, medication, or so forth to one or more ports or through all or portions of the surface area of the dilators. The hollow core dilators may also be flexible allowing for irrigation, suction, and/or the use of one or more medical instruments (e.g., fiber optic cameras, balloon catheters, injection devices, etc.).

[0041] In another embodiment, the nasal dilator may have a C-shape or a slit along all or a portion of the nasal dilator. The lumen may then be used to inflate an elongated balloon within the nasal dilator to perform additional dilation. Inflation of the balloon

opens/expands the nasal dilator increasing its outer diameter to thereby perform dilation.

[0042] In another embodiment, the dilator may be utilized as part of a dilation system to extend a bougie that performs dilation. The dilator may act as a guide, carrier and/or portal for a bougie that is integrated with, attached to, or mounted on the dilator. The bougie may be advanced based on user feedback (e.g., the user manually pushing or pulling the bougie or components attached to the bougie), mechanical advancement, pneumatic/hydraulic advancement, or electrical advancement.

[0043] In one embodiment, the dilators may be stand-alone devices that are easily manipulated. In another embodiment, the dilators may be attachable to, remotely connected/operated by and/or integrated with other systems, such as optical systems (e.g., fiber optic or wireless cameras), suction systems, medication delivery systems, or so forth.

[0044] FIGs. 1A-1B are schematic, side and front views of a a sinus dilator 100 in accordance with an illustrative embodiment. The sinus dilator 100 may be configured for performing dilation of the frontal sinus. In one embodiment, the sinus dilator 100 may include a shaft 102 a neck 104, and the dilation tip 106. Each of the dilators described herein may be one-sided or two-sided (i.e., a dilation tip on one or both terminal ends of the tool). The sinus dilator 100 may also include a neck 108 and the dilation tip 110.

[0045] In one embodiment, the shaft 102, neck 104, and dilation tip 106 may be formed from a single piece of material, such as metal, plastic, polymers, or combinations of each, including all specifically listed materials contemplated here and throughout the description. In another embodiment, a head or tip portion of the sinus dilator 100 may be configured to be attached, coupled, or mounted to and/or removed from the shaft 102. The nasal dilator 100 may be fully formed utilizing a mold in a preconfigured size and shape. In another embodiment, the nasal dilator 100 may be formed in a straight form and then bent to shape the necks 104, 108 as shown utilizing a bending machine or before use by a user. As shown, the necks 104, 108 may utilize an elongated curve in order to best reach the frontal sinuses. The nasal dilator 100 has a material modulus (e.g., modulus of elasticity) sufficient to maintain the angle of the dilation tip 106 and shape of the nasal dilator 100 during utilization.

[0046] Although not shown, the shaft 102 may be configured to extend further for manipulation by the user; extension of the shaft 102 may performed telescopically or by expansion of a flexible material, by attaching a longer shaft 102, or by adding shaft sections to an existing shaft 102. In another embodiment, the shaft 102 may include a handle, grips, or other like geometrical components for manipulating the sinus dilator 100. The shaft 102 may include knurling, knobs, or other patterns. For example, the shaft 102 may be threaded into a handle or may include a coupling mechanism or snap attachment for attachment to a grip, handle or other feature that may be manipulated. In other embodiments, the sinus dilator 100 may be configured to be utilized with other medical devices, systems, or equipment.

[0047] The necks 104, 108 of the sinus dilator 100 may be configured and shaped to reach the sinus being evaluated and dilated based on positioning and manipulation of the medical professional. The curvature of the necks 104, 108 may vary between an extended 90° curve and a shorter more abrupt 90 ⁰ curve (see FIG. 3A for example). The dilation tips 106, 110 are the portion of the sinus dilator 100 that impinge upon the sinus walls to perform dilation. The angle and shape of the dilation tip 106 may vary as are further shown in FIGs. 5A-7C and 17A-17E.

[0048] In one embodiment, the sinus dilator 100 is completely rigid. The diameter of the dilation tips 106, 110 may vary. For example, the dilation tips 106, 110 may represent any number of sizes for incrementally dilating the sinuses. As a result, a medical professional may utilize the dilation tip 110 followed by the dilation tip 106 to dilate the sinuses of a patient. Incremental dilation may allow for more effective results and may prevent the patient from experiencing unnecessary pain. For example, the sinus walls may experience less bleeding, tearing, or trauma when dilated incrementally. In addition, the medical professional may be able to select a dilator with the appropriate sizing that corresponds to the needs of the patient. In some examples, the dilation tips 106, 110 may represent 2 mm and 3 mm, 3 mm and 4 mm, 4 mm and 5 mm, 2 mm and 4 mm, 3 mm and 5 mm, or any number of incremental changes or iterative combinations. The dilation tips 106, 110 may also be the same size in the event that one of the dilation tips 106, 110 becomes contaminated. As shown, the sinus dilator 100 may have a slight curve for accessing and dilating the frontal sinuses.

[0049] In another embodiment, the sinus dilator 100 may include an inner core or structural skeleton/frame (e.g. rigid or formable) (not shown) for retaining a shape, such as inner metal or plastic core, with an outer plastic skin, coated rubber, or polymer surface that is low friction (also not shown). The metal core, frame or skeleton may allow the sinus dilator 100 to be bent or formed into position allowing the sinus dilator 100 to be customized for each patient. The core material, given that is covered by an outer shell/skin, can take advantage of a wide variety of materials that are bendable, shapable, formable, or configurable, and that include the ability to maintain form during use. The core material can be a memory shapable material such as a shape-memory alloy, including for example, copper- aluminum-nickel or nickel-titanium (NiTi). For example, the tip may be configured to expand from one diameter to another diameter while in use, based on, for example, the change in temperature from the ambient environment (e.g., office, operating room, etc) and the use environment (e.g., sinus cavity, body orifice, etc.) to perform dilation. The shape change temperatures can be configured based on the change in temperature of the body and some other reference temperature (e.g., office, operating room, etc.). The outer surface provides reduced friction for easy insertion into the nose of the patient. In one embodiment, a low friction surface or coating may be utilized. Both the skeleton and the skin may be configured of a material that is hand-bendable or tool- bendable. The core, frame or skeleton of the sinus dilator 100 may be of a material retains its bent shape thereby maintaining the outer coating/skin in the same bent shape as the core, frame, or skeleton. The frame or skeleton may be configured as a laminate type material where one of the layers of the laminate is capable of retaining the customized shape. The core, frame or skeleton may be formed from a configurable metal, plastic, rubber, or composite that maintains its shape for accessing and dilating the sinuses. The sinus dilator 100 may have a body formed from a single material, such as a shape memory material or a hand-bendable plastic, rubber, metal or like material.

[0050] Any number of materials, such as metal, plastic, polymers, or composites may be utilized to form the shape, and curvature of the shaft 102, the neck 104, and the dilation tip 106 for properly performing the dilation procedure.

[0051] Turning now to FIGs. 2A-2B illustrating a sinus dilator 200 in accordance with an illustrative embodiment. The sinus dilator 200 may include a shaft 202 that extends into the dilation tips 206, 210. The shaft 202 may be the handle of the sinus dilator 200. The sinus dilator 200 may be inserted into the nose of the patient to perform dilation of the sphenoid sinus. The size of the dilation tips 206, 210 may vary as previously noted. The dilation tips 206, 210 are shown as rounded to prevent unwanted damages to the sphenoid sinuses while still performing dilation. The shaft 202 may be cylindrical, rectangular, octagonal, or include or utilize any number of other shapes. In one embodiment, the shaft 202 may include or more flat portions, grooves, ribs, diameter changes, indentations, finger holes, knobs, secondary handles, or so forth to provide a medical professional a better grip on the shaft 202 as well as allowing for more accurate manipulation of the sinus dilator 200.

[0052] FIG. 2B and 2C further illustrate embodiments of the nasal dilator 200. In FIG. 2B, the shaft 202 may further include beveled or chamfered edges. The shaft 202 and the corresponding chamfered edges may provide a more slip-resistant grip for the medical professional. The nasal dilator 200 of FIG. 2B may also include indicators 214 that indicate measurements from the end of the dilation tip 206. In one embodiment, the indicators 212 may be indentations as shown. The indicators 212 may also be protrusions, written text, grooves, diameter changes, or other markings. The indicators 212 provide the medical professional important information regarding depth of the nasal dilator 200 in the body or nose of the patient to prevent injuries and to provide better guidance and feedback.

[0053] In another embodiment, a collar (not shown) may be slidably attached to the nasal dilator 200. For example, the indicators 212 may be configured to receive a sliding collar. The sliding collar may be configured to abut against the nose of the patient to prevent over insertion when the desired depth is reached. As a result, the medical professional may ensure that the nasal dilator 200 is not overextended into the sinuses of the patient. The collar may be any number of components or obstructions that may be attached to or integrated with the nasal dilator 200 for preventing further entry of the nasal dilator 200 into the nose of the patient. For example, the collar may be circularly shaped with an outer diameter too large to pass through a sinus opening, nostril opening or other anatomic feature.

[0054] The way in which the shaft 202 tapers to the dilation tips 206, 210 may vary. For example, the shaft 202 may taper uniformly or asymmetrically to the dilation tips 206, 210.

[0055] Turning now to FIG. 3A and 3B showing a side-view and a front view,

respectively, of the nasal dilator 300 including a shaft 302 and dilation tips 306, 310. In one embodiment, the dilation tips 306, 310 may have the same size for utilization in the sphenoid sinus for the dilation tip 306 and in the maxillary sinus for the dilation tip 310. As shown, the dilation tip 310 may include a different curvature of neck 308 for accessing the maxillary sinus. The curvature of the neck 308 may be significant enough to access the maxillary sinus while still allowing the working portions of the sinus dilator 110 (those that are inserted within the patient including the dilation tip 310) to be inserted and removed from the patient during the dilation procedure. The length of the shaft 302 and the overall length of the nasal dilator 302 may vary based on the preferences of the medical professional.

[0056] FIG. 3C illustrates the nasal dilator 330 in various sizes. The nasal dilators 330 can be similar to the nasal dilator 300. For example, the nasal dilators 300 may be sized as 2 mm, 3 mm, 4 mm, and 5 mm, as shown by the nasal dilators 330. The medical

professional can utilize any combination of the nasal dilators to dilate the sinuses of a patient.

[0057] Turning now to FIG. 4, showing nasal dilators 400 in accordance with an illustrative embodiment. The nasal dilators 400 are similar to the nasal dilator 100 of FIGs. 1A-1B. In one embodiment, the nasal dilators 400 can include dilation tips sized at 2 mm, 3 mm, 4 mm, and 5 mm.

[0058] Turning now to FIGs. 5A-C showing dilation tips 502, 504, 506. The dilation tips 502, 504, 506 are shaped similarly, but sized differently. In one embodiment, the dilation tips 502, 504, 506 are sized at 3 mm, 4 mm, and 5 mm, respectively. Other sizes are contemplated as necessary. For example, the tips may be sized at 2 mm or 6 mm. The dilation tips 502, 504, 506 may be utilized for dilating the maxillary sinuses. The dilation tips 502, 504, 506 include a 90° curve. Other angles are contemplated as necessary. For example, the dilation tips 502, 504, 506 could include a preset or user-created angle less than or greater than a 90° curve.

[0059] Turning now to FIGs. 6A-C, showing dilation tips 602, 604, 606. The dilation tips 602, 604, 606 may be utilized to dilate the sphenoid sinuses in accordance with an illustrative embodiment. In one embodiment, the dilation tips 602, 604, 606 are sized at 3 mm, 4 mm, and 5 mm, respectively. Other sizes are contemplated as necessary. For example, the tips may be sized at 2 mm or 6 mm.

[0060] Turning now to FIGs. 7A-C, showing dilation tips 702, 704, 706. The dilation tips 702, 704, 706 may be utilized for dilation of the frontal sinuses. The dilation tips 702, 704, 706 may also have any number of sizes as previously outlined. In one embodiment, the dilation tip 706 may define a lumen 708 enclosed by sidewalls 710 and an opening 712. The dilation tip 706 may also be utilized for performing dilation of the frontal sinuses as well as providing suction, medication, or surgical instruments through the lumen 708. The sidewalls 710 are sufficiently thick to ensure that the dilation tip 706 does not break or bend during utilization. In one embodiment, the lumen 708 may be utilized to deliver saline to the sinuses of the patient and may then be utilized to suction the failing mucous, and other fluids from the frontal sinuses.

[0061] The sidewalls 710 can form an inner core or structural skeleton/frame (e.g. rigid or formable) (not shown) for retaining a shape, such as inner metal or plastic hollow core, with an outer plastic skin, coated rubber, or polymer surface that is low friction (also not shown). The hollow metal core, frame or skeleton may allow the tip 706 to be bent or formed into position allowing the tip 706 to be customized for each patient. The hollow core material, given that is covered by an outer shell/skin, can take advantage of a wide variety of materials that are bendable, shapable, formable, or configurable, and that include the ability to maintain form during use. The core material can be a memory shapable material such as a shape-memory alloy, including for example, copper-aluminum-nickel or nickel-titanium (NiTi). For example, the tip 706 may be configured to expand from one diameter to another diameter while in use, based on, for example, the change in

temperature from the ambient environment (e.g., office, operating room, etc) and the use environment (e.g., sinus cavity, body orifice, etc.) to perform dilation. The shape change temperatures can be configured based on the change in temperature of the body and some other reference temperature (e.g., office, operating room, etc.). The outer surface of the tip 706 provides reduced friction for easy insertion into the nose of the patient. In one embodiment, a low friction surface or coating may be utilized. Both the hollow core formed by sidewalls 710 and the skin may be configured of a material that is hand- bendable or tool-bendable. The sidewalls 710 of the tip 706 may be of a material retains its bent shape thereby maintaining the outer coating/skin in the same bent shape as the sidewalls 710. The frame or skeleton may be configured as a laminate type material where one of the layers of the laminate is capable of retaining the customized shape. The sidewalls 710 may be formed from a configurable metal, plastic, rubber, or composite that maintains its shape for accessing and dilating the sinuses. The sidewalls 710 can have a body formed from a single material, such as a shape memory material or a hand-bendable plastic, rubber, metal or like material.

[0062] In other embodiments, the nasal dilators may define one or more lumens for providing suction, medication, tools, or so forth spontaneously. For example, the dilation tip 706 may include an irrigation lumen and a suction lumen.

[0063] Turning now to FIGs. 8A-B, showing a side view and a front view of a nasal dilator 800 in accordance with an illustrative embodiment. The nasal dilator 800 may include a shaft 802, neck 804, dilation tip 806, neck 808, and dilation tip 810. The nasal dilator 800 includes a very slight angle for the neck 804 for dilating the sphenoid sinuses. In one embodiment, the dilation tip 806 includes a bulbous contoured head for performing sinus dilation. The dilation tip 806 increases in diameter wider than the neck 804 and at least a portion of the tapered portion of the shaft 802.

[0064] In another embodiment, the dilation tip 806 can be more conically shaped allowing the sinus to dilate to a level based on the pressure applied by the medical professional and/or the penetration depth. The slope and angle of the conical shape may vary based on the preferences of the medical professional. For example, the dilation tip may be rounded at the first end (entry point) and increase to approximately 5 mm in diameter at the other end. Other sizes are contemplated, such as an increase in size 3 mm, 4 mm, and 6 mm, respectively.

[0065] The nasal dilator 800 may also include the dilation tip 810. The neck 808 and the dilation tip 810 are angled to perform dilation of the maxillary sinus. As shown the neck 808 and the dilation tip 810 can be configured at an angle greater than a 90° angle. [0066] Turning now to FIGs. 9A-9B, showing a side view and a front view of a nasal dilator 900 in accordance with an illustrative embodiment. The nasal dilator 900 may include the dilation tips 906, 910 is shown. The dilation tip 906 may be slightly bulbous for performing dilation of the sphenoid sinus. The dilation tip 906 may include a collar 912, having at least the same or greater diameter than the largest diameter of the dilation tip 906, which prevents insertion of the dilation tip 906 into the sinus beyond the collar 912. The dilation tip 910 may be angled (e.g., at a 90° or greater angle) for dilation of the maxillary sinus.

[0067] Turning now to FIGs. 1 OA- IOC showing a hollow-core nasal dilator 1000 in accordance with an illustrative embodiment. In one embodiment, the nasal dilator 1000 may include a removable head 1002, shaft neck 1006, dilation tip 1008, handle 1010, and port 1012. The nasal dilator 1000 defines one or more lumens 1014 through the body of the nasal dilator 1000 including the removable head 1002, a connector, 1016, and the handle 1010. The nasal dilator 1000 may be customized for the needs of the patient.

[0068] The nasal dilator 1000 may include an opening 1009 at the dilation tip 1008 for performing suction or instrument passage/inspection or providing irrigation. In another embodiment, the nasal dilator 1000 may include a number of openings defined within the removable head 1002. The nasal dilator 1000 may be configured to receive any number of different dilation tips. For example, the medical professional may insert a different tip for performing dilation of the frontal, sphenoid, and maxillary sinuses in one treatment or incrementally. In another embodiment, the nasal dilator 1000 may be a single integrated object that is reusable or disposable.

[0069] The removable head 1002 may connect to the handle 1010 utilizing any number of known techniques or systems. In one embodiment, the removable head 1002 may connect to the handle 1010 utilizing a connector 1016. For example, the connector 1016 may utilize mechanical, pneumatic (e.g. vacuum seat), magnetic, or other components. For example, the connector 1016 may connect to the handle utilizing threaded portions (not shown). The removable head 1002 can be removably attached to the handle 1010 utilizing threads, a vacuum seal, magnetics, an interference fit, bearings, seals, rings, pins, spring- loaded interconnects, or so forth. The connector 1016 may be integrated with the removable head 1002 or may be separately connected. In one embodiment, the connector 1016 fits into a port 1018 of the handle 1010. [0070] The connector 1016 may include a release (not shown) that can also be configured with a catch, dog, or spring-operated ball that secures the removable head 1002 to the handle 1010. For example, the release may be a button, slide or lever that may be activated by the medical professional to connect or disconnect the handle 1010 and the connector 1016.

[0071] The nasal dilator 1000 may be configured as a stand-alone instrument, tool, or device. In another embodiment, the nasal dilator 1000 may be configured to receive suction, irrigation, or other medical instruments (e.g. fiber optic camera, wireless camera, light source, etc.) through the port 1012. The port 1012 may be threaded or ribbed for connection to one or more other instruments, lines, systems, or so forth (e.g. DISS threads and fittings). The port 1012 may also include bearings, ribs, locking systems, hoses, barbs, couplers, nuts, sleeves, or other connection points as are known in the art. The handle 1010 may include knurling, patterns, or grips for preventing slippage during utilization of the nasal dilator 1000. In another embodiment, the port 1012 may be positioned at a midpoint or other position of the nasal dilator 1000. The port 1012 may extend parallel, perpendicular, or at an angle to the handle 1010.

[0072] The one or more lumens 1014 or channels may also be configured to house one or more components, mechanisms, or constructs for manipulating all or portions of the nasal dilator 1000. The diameter of the one or more lumens 1014 may vary based on the diameter of the nasal dilator 100. The lumen 1014 may be uniform in diameter or may taper or widen based on the available space within the nasal dilator 1000. In one example, the lumen 1014 may decrease in diameter as the lumen 1014 approaches the working end of the dilation tip 1008 to ensure that the integrity and strength of the removable head 1002 are maintained.

[0073] Although FIGs. 1 OA- IOC show only one end configured with a removable head 1002, the dilator 1000 can be configured to include a removable head 1002 on both ends of the handle 1010 and a port 1012 in the handle for providing the herein described functionality of performing suction or instrument passage/inspection or providing irrigation.

[0074] Turning now to FIGs. 1 lA-1 ID, showing a nasal dilator 1100 in accordance with illustrative embodiments. The nasal dilator 1100 may include a handle 1110 and connector 1116 that is configured differently. The connector 1116 may be shaped to fit. In one embodiment, the handle 1010 and connector 1116 include extensions or tabs configured to interlock further preventing separation of the components of the nasal dilator 1100 during utilization. In another aspect, the handle 1010 and connector 1116 can be configured with in one of the connector/release features described for FIGs. lOA-lOC.

[0075] Turning now to FIG. 12A-12C showing a cut-away view of a nasal dilator 1200 in accordance with an illustrative embodiment. In one embodiment, the nasal dilator 1200 may include removable heads 1202, 1204, 1206 each of which includes neck 1208, 1210, 1212 and dilation tips 1214, 1216, 1218. The removable heads 1202, 1204, 1206 may be connected to handle 1230 including port 1220, lumen 1222, and connector 1224 for connecting to hose 1216.

[0076] The removable heads 1202, 1204, 1206 may include a connector 1226 that screws into the port 1220 utilizing threads 1228. The threads 1228 may be positioned such that the dilation tips 1214, 1216, 1218 are aligned in a desired direction. In another embodiment, the threads 1228 may be aligned in a random direction for randomly aligning the dilation tips 1214, 1216, 1218. The removable heads 1202, 1204, 1206 may be molded, lathed, or so forth. The threaded connection can be configured with a protrusion and channel connector wherein the protrusion locks in the channel with the dilation tips 1214, 1216, 1218 aligned in a desired direction. The bend in the necks 1208, 1210, 1212 can be pre-formed or bent after manufacturing or molding as further described herein.

[0077] The lumen 1222 through the nasal dilator 1200 may be uniform in diameter or may vary as necessary. In one embodiment, transitions between different diameters of the lumen 1222 may have smooth or angled transitions to prevent fluids and solids from accruing during utilization and to ease the cleaning process. The nasal dilator 1200 may minimize blockages due to stepped transitions. For example, a pipe cleaner or other flexible cleaner may be utilized along with an autoclave to clean the nasal dilator 1200.

[0078] In one embodiment, the removable heads 1202, 1204, 1206 or handle 1208 may define a relief hole, valve, or port (not shown) that may be utilized to adjust suction provided through the nasal dilator 1200. When the relief valve is covered/closed, all suction can be directed to the dilation tip. Conversely, when the relief valve is uncovered/open, at least a portion of the suction passes through the relief valve and the dilation tip. For example, the medical professional may leave the relief hole uncovered to keep the suction minimized (e.g., to prevent potential injuries to the patient). The medical professional may cover the relief hole to maximize the suction through the nasal dilator 1200 to remove lots of fluids, solids, or to clear the lumen 1222 of the nasal dilator. The relief hole may also include a valve, button, or so forth that may be utilized to activate flow through the through hole, deactivate flow through the through hole, or to adjust the amount of gas/fluid allowed through the through hole (and correspondingly the lumen 1222).

[0079] The hose 1216 may represent a suction or irrigation hose. In another embodiment, the hose 1216 may represent another medical instrument, such as a fiber optic camera, balloon dilator, or other system.

[0080] Turning now to FIGs. 13A-13F, showing a flexible dilator 1300 in accordance with an illustrative embodiment. The flexible dilator 1300 may be one-sided or two sided. In one embodiment, the flexible dilator 1300 may be utilized for all of the sinuses of a user and disposed of afterwards. For example, the flexible dilator 1300 may be used in the sphenoid sinuses first and then bent to fit the frontal sinuses before further bending the flexible dilator 1300 to dilate the maxillary sinuses. A bending tool may be utilized to ensure the desired angle is achieved. In one embodiment, the flexible dilator 1300 is a single-use disposable tool. In another embodiment, the flexible dilator 1300 may be cleaned and reused.

[0081] In one embodiment, the flexible dilator 1300 may include a handle 1302, indicators 1304, bendable support 1306, a dilation tip 1308, and a cover 1309. As previously noted, the indicators 1304 on the dilation tip 1308 and the handle 1302 may indicate the measurements from a tip 1310 of the flexible dilator 1300.

[0082] In one embodiment, the bendable support 1306 is connected to or integrated into the handle 1302. The bendable support 1306 represents the portion of the flexible dilator 1300 that may be bent or customized for dilation of the separate sinuses. In one embodiment, the bendable support 1306 includes wires 1312 of varying gauge (based on the desired stiffness/rigidity of the flexible dilator 1300) that are twisted together. The thickness of the wires 1312 as well as the number of twists per centimeter affect how difficult the dilation tip 1308 is to bend into position. In one embodiment, twisting the wires 1312 together may be enough to secure them. In another embodiment, the wires 1312 are bonded, adhered, coated or otherwise integrated and protected in the event of a potential breakage. In one embodiment, a current or desired signal may be run through the wire 1312 to provide electronic treatment to the sinuses or other portion of the body in which the flexible dilator 1300 is utilized. The wires 1312 can be a memory shapable material such as a shape-memory alloy, including for example, copper-aluminum-nickel or nickel-titanium (NiTi). For example, the wires 1312 can be configured to expand/contract from one length/diameter to another length/diameter while in use, based on, for example, the change in temperature from the ambient environment (e.g., office, operating room, etc) and the use environment (e.g., sinus cavity, body orifice, user's hand, etc.) to control the desired stiffness/rigidity of the dilator 1300. The shape change temperatures can be configured based on the change in temperature of the body and some other reference temperature (e.g., office, operating room, etc.). Stiffness/rigidity behavior of the wires 1312 can also be controlled by introducing an electrical current thereby invoking a desired response (e.g., a change in stiffness/rigidity behavior) in the wires 1312.

[0083] In addition, the bendable support 1306 is covered by the cover 1309. The cover 1309 is the portion of the flexible dilator 1300 that performs dilation and interacts with the patient. In one embodiment, the cover 1309 is formed from a sterilized plastic, rubber, or so forth. The cover 1309 is flexible to conform to the shape imposed upon the bendable support 1306. The cover 1309 may have any number of anti-microbial or other properties.

[0084] Turning now to FIG. 14A-14C, showing another flexible dilator 1400 in accordance with an illustrative embodiment. In one embodiment, the flexible dilator 1400 may include a bendable shaft 1402, a handle 1404, a cover 1406, a first end 1408, and a second end 1410. In one embodiment, both the first end 1408 and the second end 1410 may be covered for performing dilation. The diameters of each end may vary for performing incremental or progressive dilation.

[0085] In another embodiment, the second end 1410 may uncovered. For example, the second end 1410 may be utilized as a sinus seeker. The second end 1410 may be bent into position to locate the sinuses of the patient for performing dilation. The first end 1408 may be bent into the desired shape in a manner described herein to perform dilation. In one embodiment, the cover 1406 may be removable and differently sized covers may be selected for performing dilation at different diameters. For example, the cover 1406 may be selected and positioned over the bendable shaft 1402 for performing dilation at 3 mm and then at 5 mm. In another aspect, 2 mm and 4 mm covers 1406 may be selected, or 4 mm and 6 mm covers 1406 can be selected for changing the size of the second end 1410. [0086] In one embodiment, the bendable shaft 1402 may represent a single piece of material that may be bent into position a number of times before breaking, fracturing, or otherwise failing. For example, the single piece of material may be stainless steel, including in one aspect one or more alloys for bending. In another embodiment, the bendable shaft 1402 may be formed from a polymer, alloy, or plastic material. In one embodiment, the flexible dilator 1400 is configured to be bent twice (it comes straight for utilization in the sphenoid sinuses) and utilized at least six times (two times for sphenoid, frontal, and maxillary sinuses) with an additional safety margin or range before suffering structural or functional fatigue. The flexible dilator 1400 may include an indicator that shows when it has been utilized. For example, the first end 1408 or cover 1406 may change colors when bent or when exposed to organic tissue, such as the sinuses.

[0087] In one embodiment, the bendable shaft 1402 may narrow in diameter toward the first end 1406 to ensure that the first end 1408 may be bent and configured as needed by the user. As previously disclosed, the bendable shaft 1402 may define one or more lumens (not shown) that may be utilized for any number of purposes as herein described.

[0088] FIG. 15 is a schematic, plan views of a sinus dilator 1500 in accordance with an illustrative embodiment. The sinus dilator 1500 is configured to be utilized in one or more distinct sinuses. In one embodiment, the sinus dilator 1500 may include duplicate or different dilation heads disposed at each end for treating both of the frontal, sphenoid, or maxillary sinuses. The sinus dilator may include a grip 1502, body 1504, a neck 1506, a dilation tip 1508, a neck 1510, and a dilation tip 1512. The grip 1502 may be rounded or flattened based on the preferences of the medical professional. The grip 1502 may also include knurling, ribbing, corrugations, undulations, extensions, rubber, or other highly tactile and easily gripped surfaces. For example, the dilation tip 1508 may be utilized to access the maxillary sinus(es) and the dilation tip 1512 may be utilized to access the sphenoid sinus(es). The body 1504 of the sinus dilator 1500 may be configured with attachment points to removably attach different dilation heads to either end of the body 1504.

[0089] FIG. 16 is a schematic, plan views of a sinus dilator 1600 in accordance with an illustrative embodiment. The sinus dilator 1600 may additionally include a grip 1514 and dilation tip 1516. [0090] In one embodiment, a medical professional may have access to a number of sinus dilators for the distinct sinuses and of distinct sizes as well. For example, the dilation tips may vary in configuration as well as the overall diameter utilized for performing dilation that may vary between 1 mm - 6 mm. However, other larger and smaller sizes may be available for infants, and individuals that require larger sizes.

[0091] Turning now to Figs. 17A-17E showing various embodiments of dilation in 1700, 1710, 1720, 1730, and 1740 in accordance with illustrative embodiments. The dilation ends 1700, 1710, 1720, 1730, and 1740 may also be referred to as dilation heads. The dilation ends 1700, 1710, 1720, 1730, and 1740 may utilize any number of shapes and configurations for a dilation tip including conical, protuberated, frustoconical, rounded, spherical, oval shaped, flattened, concave, convex, joined, or so forth. Such tip designs can be used on any of the dilators set forth and described herein.

[0092] In one embodiment, the dilation tip is configured to avoid the uncinate bone during utilization. The dilation end 1700 may include a dilation tip 1702 that utilizes a rounded conical shape for insertion into the sinuses of a user. The dilation tip 1702 may include a flattened portion (e.g. shaped frustoconically) at the very tip or may go to a rounded point. The dilation tip may include one or more chamfered surfaces. The dilation end 1710 may include a rounded dilation tip 1712. The rounded dilation tip 1712 is configured to prevent unwanted trauma to the sinuses of the user. The dilation end 1710 may also include the channel 138 utilized to house one or more tool operative components, a fiber optic camera, and/or light source, or apply suction/irrigation,.

[0093] In one embodiment, the dilation end 1710 may include miniature stops or limiters at the intersection of the dilation tip 1712 and the channel 1738 that prevent a fiber optic camera or light source from extending beyond the end of the dilation tip 1712. However, in other embodiments, the dilation end 1710 and the dilation tip 1712 may be configured to allow the extension of a fiber optic camera, light source, irrigation system, or suction device beyond the dilation tip 1712. The dilation end 1720 may include a dilation tip 1722 that may include a concave surface for performing dilation.

[0094] In other embodiments, distinct sides or edges of the dilation tip 1730 may be concave, convex, straight, rounded, fluted, or so forth. The dilation end 1730 may include a dilation tip 1732. The dilation tip 1732 may have a decreased entry angle for more gradually performing the dilation procedure. For example, the dilation tip 1732 may vary between 1mm in diameter at the very end of the dilation tip 1732 to a diameter of 4mm after a length of between 3 to 6 millimeters of the dilation tip 1732.

[0095] In another embodiment, the dilation end 1740 may include a dilation tip 1742. As shown, the dilation tip 1742 may include a ball, spherical, protuberated, or rounded shape at the end of the dilation tip 1742 and a narrowing section before the ball dilation tip 1742. The dilation tip 1742 may be configured to help the medical professional find the sinus before the rest of the dilation end 1700 is inserted into the sinus or other orifice for performing the dilation procedure. In one embodiment, the diameter of the ball, cone, or flattened shape may vary between 1-4 mm. The rest of the dilation end 1740 may have a diameter of between 3-6 mm with large and smaller sizes contemplated based on the dilation procedure.

[0096] FIG. 18 is a flowchart of a process for utilizing a sinus dilator in accordance with an illustrative embodiment. The process of utilizing a sinus dilator may vary based on the preferences of the medical professional and the circumstances of the patient. Although described for human sinuses, the dilation process and procedures herein described may be applied to any number of dilation procedures for humans, animals, or mechanical components.

[0097] In one embodiment, a sinus dilator is selected for a sinus procedure (step 1802). The sinus dilator may be selected from a number of sinus dilators varying from 1 mm - 6 mm in diameter at the widest for the dilating portion of the dilation head. For example, the dilation needs of adults, children, or individual users may vary based on their age, size, medical condition, and configuration of their body. In addition, distinct types of dilation tips may be utilized. The sinus dilator may be singled-sided or multiple-sided. For example, the sinus dilator may be configured to perform sinus dilation of the sphenoid, frontal, and/or maxillary sinuses.

[0098] Next, the sinus dilator is configured for utilization on a patient (step 1804). In one embodiment, the medical professional may bend, manipulate, or configure one or more portions or sections of the sinus dilator to perform dilation. For example, the sinus dilator may be configured for reconfiguration to allow for custom utilization. During step 1804, one or more dilation heads or ends may be connected to a handle or base portion of the sinus dilator. For example, dilation heads for performing dilation of the frontal and maxillary sinuses may be attached to the sinus dilator (e.g. snapped into position, screwed in, etc.).

[0099] Next, the sinus dilator is positioned within the patient and pressure is applied to perform dilation of one or more sinuses (step 1806). The medical professional may careful determine the location of the sinus utilizing the dilation tip of the sinus dilator before performing the dilation process. The medical professional may utilize any number of three dimensional forces determined to be necessary to dilate the tissue, bone, membranes, and other portions of the sinuses to perform dilation that will best help the patient.

[00100] FIG. 19 is a pictorial presentation of another dilator 1900 in accordance with an illustrative embodiment. The dilator 1900 may include a shaft 1902, dilation tips 1904, 1906, and protrusions 1908, 1910. In one embodiment, the protrusions 1908, 1910 are narrower extensions from the dilation tips 1904, 1906. The protrusions 1908, 1910 are configured to be smaller for more easily slipping into the sinuses during exploration. For example, the protrusion 1908 may have a diameter of 1 mm or less and approximately 3 mm in length while the remaining portion of the dilation tip 1904 is approximately 5 mm in length and 3 mm in diameter for performing dilation.

[00101] The dilator 1900 may provide additional benefits for performing dilation. In one embodiment, the protrusions 1908, 1910 may be utilized to find the sinus initially so that dilation utilizing the dilation tips 1904, 1906 may be performed. For example, the protrusion 1910 may be utilized to find the sphenoid sinus and the dilation tip 1906 may be inserted to perform dilation of the sphenoid sinus. Similarly, the protrusion 1908 may be utilized to find the frontal or maxillary sinus to perform dilation utilizing the dilation tip 1904.

[00102] The protrusions 1908, 1910 may be integrated with any of the dilation tips that are shown and/or described herein.

[00103] The illustrative embodiments provide a number of advantages and benefits over existing systems, tools, and devices. In one embodiment, the nasal dilators may be manufactured through printing, molding, and/or bending for substantially less than existing systems, such as balloon sinuplasty systems. The nasal dilators may be reusable or single- use and produced at a cost that is compelling as compared to existing dilation systems. In addition, the nasal dilators include fewer mechanical parts and are thus less likely to fail. Data recorded by medical professionals performing dilation procedures utilizing the dilators has indicated indicates that the dilators are as good as or superior to traditional balloon sinuplasty tools, systems, and procedures.

[00104] In one example, the following results were obtained:

[00105] In one embodiment, the results of different procedures were measured utilizing the Sino-Nasal Outcome Test (e.g., SNOT-20) because of industry acceptance and standards. The average symptom improvement demonstrates that through this sample data, the dilators as described herein were not only non-inferior to ballooon sinuplasty systems and processes (in addition to other functional endoscopic sinus surgeries (FESS)), but were actually superior. Additional data is still being obtained from patients that improve and do not follow up with their medical professional making data acquisition difficult or impossible for both the described dilators and existing balloon dilation systems.

[00106] The previous detailed description is of a small number of embodiments for implementing the invention and is not intended to be limiting in scope. The following claims set forth a number of the embodiments of the invention disclosed with greater particularity.