# Patent

## Title
Methods and devices for ostium measurement

## Abstract

Devices and methods for accurately determining the size of an ostium of a patient and in particular sinus ostium. Methods for measuring a target ostium comprise inserting the distal end portion of an ostium measuring device into a patient, locating the target ostium with the measuring device, positioning the distal end portion of the measuring device appropriately adjacent to or into the target ostium and determining the diameter(s) of the target ostium by comparing the length, diameter and/or the circumference of the portion of the distal end portion of the measuring device adjacent to or within the target ostium.

## Background
FIELD OF THE INVENTION
The present invention relates generally to medical devices, systems and methods and more particularly to methods and devices for determining the size of an ostium.
BACKGROUND OF THE INVENTION
The skull contains a series of cavities known as paranasal sinuses that are connected by passageways. The paranasal sinuses include frontal sinuses, ethmoid sinuses, sphenoid sinuses and maxillary sinuses. The paranasal sinuses are lined with mucous-producing mucosal tissue and ultimately open into the nasal cavity. Normally, mucous produced by the mucosal tissue slowly drains out of each sinus through an opening known as an ostium. If the mucosal tissue of one of these passageways becomes inflamed for any reason, the cavities which drain through that passageway can become blocked. This blockage can be periodic (resulting in episodes of pain) or chronic. This interference with drainage of mucous (e.g., occlusion of a sinus ostium) can result in mucosal congestion within the paranasal sinuses. Chronic mucosal congestion of the sinuses can cause damage to the epithelium that lines the sinus with subsequent decreased oxygen tension and microbial growth (e.g., a sinus infection).
The term “sinusitis” refers generally to any inflammation or infection of the paranasal sinuses caused by bacteria, viruses, fungi (molds), allergies or combinations thereof. It has been estimated that chronic sinusitis (e.g., lasting more than 3 months or so) results in 18 million to 22 million physician office visits per year in the United States. Patients who suffer from sinusitis typically experience at least some of the following symptoms: headaches or facial pain; nasal congestion or post-nasal drainage; difficulty breathing through one or both nostrils; bad breath; and/or pain in the upper teeth.
One of the ways to treat sinusitis is by restoring the lost mucous flow. The initial therapy is typically drug therapy using anti-inflammatory agents to reduce the inflammation and antibiotics to treat the infection. A large number of patients do not respond to drug therapy. Currently, the gold standard for patients with chronic sinusitis that do not respond to drug therapy is a corrective surgery called Functional Endoscopic Sinus Surgery (FESS).
During FESS, an endoscope is inserted into the nose and, under visualization through the endoscope, the surgeon may remove diseased or hypertrophic tissue or bone and may enlarge the ostia of the sinuses to restore normal drainage of the sinuses. FESS procedures are typically performed with the patient under general anesthesia.
Although FESS continues to be the gold standard therapy for surgical treatment of severe sinus disease, FESS does have several shortcomings. For example, FESS can cause significant post-operative pain. Also, some FESS procedures are associated with significant postoperative bleeding and, as a result, nasal packing is frequently placed in the patient's nose for some period of time following the surgery. Such nasal packing can be uncomfortable and can interfere with normal breathing, eating, drinking etc. Also, some patients remain symptomatic even after multiple FESS surgeries. Additionally, some FESS procedures are associated with risks of iatrogenic orbital, intracranial and sinonasal injury. Many otolaryngologists consider FESS an option only for patients who suffer from severe sinus disease (e.g., those showing significant abnormalities under CT scan). Thus, patients with less severe disease may not be considered candidates for FESS. One of the reasons why FESS procedures can be bloody and painful relates to the fact that instruments having straight, rigid shafts are used. In order to target deep areas of the anatomy with such straight rigid instrumentation, the physician needs to resect and remove or otherwise manipulate any anatomical structures that may lie in the direct path of the instruments, regardless of whether those anatomical structures are part of the pathology.
New devices, systems and techniques are being developed for the treatment of sinusitis and other disorders of the ear, nose, throat and paranasal sinuses. For example, various catheters, guidewires and other devices useable to perform minimally invasive, minimally traumatic ear, nose and throat surgery have been described in U.S. patent application Ser. No. 10/829,917 entitled “Devices, Systems and Methods for Diagnosing and Treating Sinusitis and Other Disorders of the Ears, Nose and/or Throat,” Ser. No. 10/912,578 entitled “Implantable Device and Methods for Delivering Drugs and Other Substances to Treat Sinusitis and Other Disorders,” Ser. No. 10/944,270 entitled “Apparatus and Methods for Dilating and Modifying Ostia of Paranasal Sinuses and Other Intranasal or Paranasal Structures” Ser. No. 11/037,548 entitled “Devices, Systems and Methods For Treating Disorders of the Ear, Nose and Throat”, and Ser. No. 11/116,118 entitled “Methods and Devices For Performing Procedures Within the Ear, Nose, Throat and Paranasal Sinuses”. Each of these applications is hereby incorporated herein, in its entirety, by reference thereto. Many of these new devices, systems and techniques are useable in conjunction with endoscopic, radiographic and/or electronic assistance to facilitate precise positioning and movement of catheters, guidewires and other devices within the ear, nose, throat and paranasal sinuses and to avoid undesirable trauma or damage to critical anatomical structures such as the eyes, facial nerves and brain.
For example, in one new procedure (referred to in this patent application as a “Flexible Transnasal Sinus Intervention” or FTSI), a dilatation catheter (e.g., a balloon catheter or other type of dilator) is advanced through the nose to a position within the ostium of a paranasal sinus or other location, without requiring removal or surgical alteration of other intranasal anatomical structures. The dilatation catheter is then used to dilate the ostium or other anatomical structures to facilitate natural drainage from the sinus cavity. In some cases, a tubular guide may be initially inserted through the nose and advanced to a position near the sinus ostium and a guidewire may then be advanced through the tubular guide and into the affected paranasal sinus. The dilatation catheter may then be advanced over the guidewire and through the tubular guide to a position where its dilator (e.g., balloon) is positioned within the sinus ostium. The dilator (e.g., balloon) is then expanded causing the ostium to dilate. In some cases, such dilatation of the ostium may fracture, move or remodel bony structures that surround or are adjacent to the ostium. Optionally, in some procedures, irrigation solution and/or therapeutic agents may be infused through a lumen of the dilatation catheter and/or other working devices (e.g., guidewires, catheters, cannula, tubes, dilators, balloons, substance injectors, needles, penetrators, cutters, debriders, microdebriders, hemostatic devices, cautery devices, cryosurgical devices, heaters, coolers, scopes, endoscopes, light guides, phototherapy devices, drills, rasps, saws, etc.) may be advanced through the tubular guide and/or over the guidewire to deliver other therapy to the sinus or adjacent tissues during the same procedure in which the FTSI is carried out. It is to be understood that, in FTSI procedures, structures and passageways other than sinus ostia may be dilated using the tools described above, tissue may be resected or ablated, bone may be restructured, drugs or drug delivery systems may be deployed, etc., as described in the documents incorporated herein by reference. Thus, for the purposes of this application the term FTSI will be generally used to refer broadly to all of those procedures, not just dilation of sinus ostia.
In FTSI procedures that include positioning of a guidewire into a paranasal sinus, the placement of the guidewire is typically confirmed by visualizing the procedure under fluoroscopy or other x-ray visualization techniques. Currently, there is no simple and accurate method or apparatus to measure the size of an ostium, and in particular a sinus ostium. Surgeons often approximate the size of an ostium endoscopically by placing a sinus seeker with an atraumatic tip of known diameter near the ostium and estimating the size of the ostium. Unfortunately, this method lacks precision or accuracy in determining the size of an ostium.
Determining the ostium size of a nasal ostium prior to surgery enables the user of a balloon catheter to determine the appropriate amount of inflation needed to open the ostium to a size for sufficient drainage. Being able to accurately measure the ostium size after surgery is also useful in determining if the FTSI procedure was successful or if further treatment is needed. Thus there is a need for methods and devices that can accurately determine the size of the ostium pre-, post-, and during such procedures.
SUMMARY OF THE INVENTION
The present invention provides methods, devices and kits for measurement of sinus ostia. A method for determining the size of a sinus ostium according to at least one embodiment provided herein includes the steps of: positioning a sinus ostium measuring device internally into a patient, locating a target sinus ostium, positioning the sinus ostium measuring device adjacent to or in the target sinus ostium, and determining the diameter of the target sinus ostium with the sinus ostium measuring device.
In at least one embodiment, the sinus ostium measuring device is positioned adjacent to the target sinus ostium.
In at least one embodiment, the sinus ostium measuring device is positioned within the target sinus ostium.
In at least one embodiment, the distal end portion of the sinus ostium measuring device is initially inserted through a nostril of the patient and then advanced into a sinus.
In at least one embodiment, determining the diameter of the target sinus ostium measurement is observed when a portion of the distal end portion is located in the sinus of the patient.
In at least one embodiment, the distal end portion of the sinus ostium measuring device is advanced towards the opening of the sinus; and placement of the distal end portion of the sinus ostium measuring device adjacent to the opening of the sinus is confirmed by visualization techniques.
In at least one embodiment, the distal end portion of the sinus ostium measuring device is advanced through the opening of the sinus; and placement of the distal end portion of the sinus ostium measuring device in the sinus is confirmed by visualization techniques.
In at least one embodiment, the visualization techniques comprise endoscopic visualization.
In at least one embodiment, the visualization techniques include fluoroscopy.
A sinus ostium measuring device is provided, including: a flexible distal end portion; a relatively less flexible proximal end portion; and at least one marker to facilitate determination of the size of a target sinus ostium.
In at least one embodiment, the distal end portion of the sinus ostium measuring device has an outside diameter configured and dimensioned to pass through a sinus ostium of a sinus.
In at least one embodiment, the distal end portion of the device includes a bend, such that a proximal part of the distal end portion is substantially aligned with a longitudinal axis of the device, and a distal part of the distal end portion is angled with respect to the longitudinal axis.
In at least one embodiment, the sinus ostium measuring device comprises a distal end, and the distal end portion is rigid or malleable.
In at least one embodiment, the sinus ostium measuring device comprises a distal end, and the distal end portion comprises a ball tip at a distal end thereof.
In some embodiments, these sinus ostium measuring devices have lumens extending therethrough. In such embodiments having lumens, guidewires may be inserted or advanced through the lumen, thereby providing sinus ostium measuring/guidewire systems that are useable for placing guidewires into various anatomical structures (e.g., into a paranasal sinus). In some embodiments that have lumens, a slot opening may extend along all or a portion of the lumen to allow a guidewire or other elongate device to be extracted laterally from all or a portion of the lumen. Structurally, a sinus ostium measuring device of the present invention may comprise an elongate substantially rigid (e.g., straight, pre-shaped, bent, curved, malleable) shaft at the proximal end, and optionally having an atraumatic distal tip. Various curves may be formed or formable in the seeker shaft.
Further in accordance with the invention, there are provided sinus ostium measuring devices that are useable to locate or access structures within the ear, nose and throat.
Kits of sinus ostium measuring devices having different sizes adapted to measure a range of dimensions are provided.
These and other advantages and features of the invention will become apparent to those persons skilled in the art upon reading the details of the devices, methods and systems as more fully described below.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an illustration of a patient being treated by a system for catheter-based minimally invasive sinus surgery according to prior art techniques.
FIG. 2a is an illustration of a partial sagittal sectional view through a human head showing one embodiment of a sinus ostium measuring device in accordance to the invention.
FIG. 2b is a perspective view of various sized distal portions of sinus ostium measuring devices in accordance with the invention.
FIG. 3a is a perspective view of one embodiment of a sinus ostium measuring device comprising a flexible measuring strip in accordance with the invention.
FIG. 3b is a perspective view of the flexible measuring strip of the device in FIG. 3a, comprising indicia in accordance with the invention.
FIGS. 4a-c are perspective views of embodiments of a sinus ostium measuring device comprising a tapered mandrel in accordance with the invention.
FIG. 5a is perspective view of an ostium measuring device comprising telescoping measurement portion in accordance with the invention.
FIG. 5b is a perspective view of the adjustment knob of the ostium measuring device of FIG. 5a. 
FIG. 5c is a partial sectional view of the device of FIG. 5a. 
FIG. 5d is a sectional view of a device (viewed from the distal end of the device) having an alternative mechanism for controlling extension and retraction.
FIG. 6 is a flow chart showing a method for measuring an ostium in accordance with the invention.



DETAILED DESCRIPTION OF THE INVENTION
Before the present devices and methods are described, it is to be understood that this invention is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.
Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited.
It must be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a tube” includes a plurality of such tubes and reference to “the shaft” includes reference to one or more shafts and equivalents thereof known to those skilled in the art, and so forth.
The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.
Turning now to FIG. 1, an illustration of a patient being treated by a system for catheter-based minimally invasive sinus surgery according to prior art techniques is shown. A C-arm fluoroscope 1000 that is useable to visualize a first introducing device 1002 (e.g., a sinus guide, guide catheter or guide tube), a second introducing device 1004 (e.g., a guidewire or elongated probe) and a working device 1006 (e.g., a balloon catheter, other dilatation catheter, debrider, cutter, etc.). The sinus guide, guide catheter or guide tube 1002 may be introduced under direct visualization, visualization provided by fluoroscope 1000 and/or from endoscopic visualization, to place the distal end of catheter or tube 1002 at a location approaching an ostium of a sinus to be treated.
Next guidewire or elongated probe 1004 is inserted through catheter or tube 1002 and distally advanced to extend the distal end of guidewire or elongated probe through the ostium to be treated and into the sinus that the ostium opens to. Proper placement often involves advancement and retraction of the distal end of guidewire or elongated probe, under fluoroscopic visualization, until it has been visually confirmed that the distal end of the guidewire or elongated probe is located where the surgeon believes the appropriate sinus to be located, relative to the other features of the patient's head that are visualized under fluoroscopy.
Once guidewire or elongated probe 1004 has been properly placed, working device 1006 is next passed over the guidewire or elongated probe 1004, under visualization via fluoroscope 1000 and/or an endoscope (not shown) that has been inserted adjacent catheter or tube 1002, to place the working end of working device 1006 in the target location where a surgical procedure is to be performed. Typically, the guidewire or elongated probe 1004 remains in place during the procedure. Under the same type(s) of visualization, the working (distal) end of working device 1006 is then actuated to perform the desired surgical procedure. In the case of a dilation catheter, the balloon at the distal end portion of catheter 1006 is expanded once it has been located across the ostium. This expansion acts to open the ostium to allow proper mucus flow. After performance of the desired surgical procedure, the working device 1006 is deactivated and withdrawn from the patient, after which the remaining devices are withdrawn to complete the procedure.
By using the devices and methods described herein, accurate measurement of the sinus ostia is important for pre-operative and intra-operative planning. For example, a surgeon may wish to know the size of the ostium prior to choosing a balloon for dilation. Also, it is useful to document the size of the dilated ostium, both immediately after the dilation and weeks or months post operatively to determine the overall success of the surgery.
It is to be appreciated that the devices and methods of the present invention relate to the measuring, accessing and dilatation or modification of sinus ostia or other passageways within the ear, nose and throat. These devices and methods may be used alone or may be used in conjunction with other surgical or non-surgical treatments, including but not limited to the delivery or implantation of devices and drugs or other substances as described in co-pending U.S. patent application Ser. No. 10/912,578.
FIG. 2a is an illustration of a partial sagittal sectional view through a human head showing one embodiment of a ostium measuring device 10 within a paranasal sinus in accordance with the invention. Ostium measuring device 10 comprises a distal end 12 and proximal end 14, where the distal end has a spherical or ball shape configured to measure a sinus ostium. Distal and proximal ends 12, 14 are joined or coupled to an elongated shaft or body 16. The proximal end 14 of ostium measuring device 10 and the adjacent portion of shaft 16 may be straight or curvilinear, rigid, semi-rigid, resilient or malleable, or it may incorporate one or more preformed curves or bends to allow better access of the distal end 12 to an ostium. In embodiments where the shaft 16 and/or proximal end 14 of ostium measuring device 10 is curved or bent, the deflection angle of the curve or bend may be in the range of up to about 135 degrees. The curvature of the device 10 may range, for example, from about zero to about 120 degrees. Several examples of embodiments include bends of about zero degrees, about 30 degrees, about 70 degrees, about 90 degrees and about 110 degrees, respectively.
In embodiments wherein the proximal end 14, distal end 12 and/or shaft 16 are malleable or resilient or contain portions which are malleable or resilient, such portions may be made from materials such as metallic tubes, rods (e.g. rods embedded in a shaft or wire. Suitable biocompatible material(s) that can be used for construction of an ostium measuring device include but are not limited to metals e.g. malleable stainless steel, fully annealed stainless steel, copper, aluminum, titanium, nickel-titanium alloy (e.g., Nitinol), etc.; and polymeric materials such as polyether block amides (e.g., Pebax), polyether ether ketone (PEEK), Nylon, polyethylene, polyurethane, etc., which may be in the form of glass or carbon-reinforced composites.
The proximal end 14 in many embodiments may be configured to couple to a handpiece (not shown) or be inserted into a guide catheter (not shown) to increase stability and/or facilitate the placement of the ostium measuring device 10 when inserted into an opening in a patient, such as a nostril or ear. The proximal end 14 may comprise portions which are rigid while other sections of the proximal end 14 may be resilient or malleable and made of materials mentioned above. The flexible nature of ostium measuring device 10 allows for passage and tactile feedback to the user through tortuous anatomy.
The distal end 12 of the ostium measuring device 10 may vary in size as shown in FIG. 2b. The diameter of the distal end 12 may be in the range from about 0.5 mm to about 6.0 mm, more preferably about 1 mm to about 3 mm, and a kit of devices 10 may be provided with diameters having incremental differences of about 0.5 mm, for example, or other incremental variations, e.g., in the range of about 0.25 mm to about 1.0 mm, for example. Having a range of sized ostium measuring devices 10, allows the user to identify which sized distal end best fits in or near the target ostium, better enabling the size of the ostium to be determined. The distal end 12 may be made of materials to aid in visual navigation to locate the target ostium within the patient. Such materials may include but are not limited to at least one radio-opaque marker (e.g., comprising platinum, tungsten, stainless steel, or the like), eletromagnetic, piezoelectric or magnetic materials, depending on the visual navigational technique being utilized for ostium measurement. Distal end 12 may be detachable and interchangeable to allow use of differently sized or shaped ends 12. Further optionally, coatings such as reflective coatings and/or polarized coatings may be applied to improve visibility thereof view endoscopic visualization. Colored coating may be applied to proved better contrast with surrounding tissues when the distal end is in situ and being viewed via endoscopic visualization, for example.
Some embodiments of the invention may utilize fluoroscopy or other x-ray techniques in combination with, or in lieu of endoscopic visualization, to navigate the ostium measuring device 10 to the target ostium and also to determine the diameter of the target ostium by a fluoroscopic image. The measuring device 10 may comprise radio-opaque markings on a portion of the distal end 12 which is descriptive of the diameter of that particular ostium measuring device 10 being used. Such markings may include but are not limited to lines, stripes or solid marked spherical ends correlating to a certain sized distal end 12. The distal end 12 may also comprise indicia within the radio-opaque marking to aid the user in identifying which size measuring device is being utilized at that particular moment.
FIG. 2a also depicts various steps in a method of measuring an ostium with an ostium measuring device 10 in accordance with the invention. The method comprises, in general terms, introducing an ostium measuring device 10 through a nostril 1011 and through a nasal cavity 1012 to a location close to a target ostium such as, for example, ostium 1014 of a sphenoid sinus 1016. The method further comprises placing the distal end 12 of ostium measuring device 10 into the target ostium 1014. If the distal end 12 moves easily through the ostium 1014, an ostium measuring device 10 comprising a larger distal end 12 is utilized until a compatible fit of the distal end 12 of the ostium measuring device 10 with the target ostium 1014 has been determined by the user. After the ostium 1014 has been measured, ostium measuring device 10 is withdrawn and removed. It will be appreciated that the present invention may also be used to measure any sinus ostium or other man-made or naturally occurring anatomical opening or passageway within the nose, paranasal sinuses, nasopharynx or adjacent areas.
FIG. 2b is an illustration of three ostium measuring devices 10 with spherical distal ends 12 of varying sizes. The size of the spherical distal end 12 of the ostium measuring device of the embodiments shown in FIGS. 2a and 2b, range, for example, from about 0.5 mm to about 6 mm in diameter, and more preferably from about 1 mm to about 5 mm. The distal end 12 may be oblong or oval in shape in order to better fit certain shaped target ostia such as ostia of the frontal, sphenoid and/or maxillary sinuses, for example. In these embodiments, the distal end 12 of the measuring device 10 will have two diameters, i.e. the length and width distances of the oblate or oval shape, allowing two ostium measurements to be taken using the same distal end 12.
The various sized ostium measuring devices 10 may be provided to the user in the form of a kit. The ostium measuring kit in certain embodiments comprises at least two ostium measuring devices 10, each ostium measuring device 10 comprising a distal 12 and an proximal end 14, the distal end 12 varying in diameter for each ostium measuring device within the kit and the proximal end identifying the size of the distal end. The diameter of the distal ends may vary in increments of about 0.5 mm to about 1 mm. The kit may be used pre-, post- and/or during surgery to determine the size of the target ostium. In some embodiments, each measuring device within the kit comprises a unique radio-opaque marking which distinguishes it from the other ostium measuring devices 10 within the kit. The radio-opaque markings allow the user to navigate the measuring devices to the target ostium and determine the size or diameter of the ostium by knowing the diameter of the ostium measuring device which provides the best fit with the target ostium. In another embodiment, each measuring device within the kit comprises a unique colored coating or marking which distinguishes it from the other ostium measuring devices 10 within the kit.
Another embodiment of the kit may comprise a single ostium measuring device with at least three detachable and interchangeable distal ends 12 of varying size or diameter. The distal ends 12 may be releasibly fastened to the device 10 by interfitting threading, snap fitting, tensional engagement, friction fit or other coupling means.
Referring to FIGS. 3a and 3b, there is shown another embodiment of an ostium measuring device 20 in accordance with the invention. The ostium measuring device 20 shown in FIG. 3a, comprises a distal end portion 22, a shaft or body 23, and proximal end portion 24. The distal end portion 22 is configured to facilitate measurement of the size of a target ostium. Both the distal and proximal end portions, 22 and 24 respectively, as well as shaft 23, have a substantially flattened or ribbon shape in the embodiment shown in FIGS. 3a and 3b. The distal end portion 22 further comprises an atraumatic tip 25 so as not to damage patient tissue while locating the target ostium. The distal end portion 22 may further comprise at least one flexible or malleable portion 26 to aid in the maneuvering of the measuring device 20 within a patient. In certain embodiments, the distal end portion 22 is configured to enable a curve 26 to be set in the distal end portion to aid in the measuring of surfaces normal to the long axis of the measuring strip. The embodiment shown in FIGS. 3a and 3b comprises a flexible ribbon 20 that is deliverable to a sinus ostium by use of a guide catheter 30, in a manner as illustrated in FIG. 3a. The ribbon material is such that a preset curve can be applied to the distal tip portion. The material may comprise, but is not limited to one or more of the following: malleable stainless steel, Nitinol, spring tempered stainless steel, nylon, polyimide, Pebax, PEEK. The atraumatic tip 25 of the ribbon 20 may have rounded, beveled or chamfered edges.
In many embodiments, the distal end portion 22 of ostium measuring device 20 further comprises stripes or markings 28a, 28b, 28c, 28d, etc. which are visible by endoscopy and/or fluoroscopy or other x-ray imaging techniques to aid in measuring the target ostium. Other indicators may be used alternatively to stripes, such as dots, dotted lines, or other markers. The markings 28a, 28b,28c,28d, 283, 28f, etc. may be of alternating contrasting stripes of known height and width to allow the user to endoscopically view and count the stripes and thereby determine the diameter of the target ostium. Note, that although six such stripes are shown in FIG. 3b and ten such stripes are shown in FIG. 3a, the present invention is not limited to these numbers of stripes, as the total number of stripes may vary, depending upon the height and width of the stripes and upon the particular application for which that particular device is designed to be used. Additionally, or alternatively, the markings 28a, 28b, 28c, 28d, etc. may be of alternating radio-opaque and radio-transparent stripes of known height and width to allow the user to count the stripes and determine the diameter of the target ostium. The height and width size of the stripes 28a, 28b, 28c, 28d may vary depending on the type of ostium that the device is designed to measure. Generally, the alternating stripes 28a, 28b, 28c, 28d are of equal height and are evenly spaced, each by about 1 mm in width, but in some embodiments the incremental changes in width can be smaller, e.g. about 0.5 mm in width. In certain embodiments the height of each stripe may vary incrementally, such that stripes 28a, 28b, 28c, 28d, etc., are 0.5 mm, 1.0 mm, 1.5 mm, 2.0 mm, etc., in width, in ascending or descending order, i.e., an increment of change in height of 0.5 mm. In other embodiments, the increment of change in height between each stripe may be smaller or greater than 0.5 mm, e.g., 0.25 mm, 0.3 mm, 0.6 mm or some other incremental value. In other embodiments each stripe 28a, 28b, 28c, 28d is of the same height.
The malleable portions as well as semi-rigid portions of the ostium measuring device 20 may be made from materials such as metallic or polymeric ribbon. Suitable biocompatible material(s) that can be used for construction of an ostium measuring device 20 include but are not limited to metals e.g. malleable stainless steel, fully annealed stainless steel, copper, aluminum, titanium, nickel-titanium alloy (e.g., Nitinol), etc.; polymers e.g. Pebax, PEEK, Nylon, polyethylene, polyimide, etc, as described for the embodiment of FIG. 2a and FIG. 2b above.
Proximal end portion 24 and shaft 23 of the ostium measuring device 20 can be positioned within a guide catheter handpiece 30. The guide catheter 30 comprises a threaded luer (not shown) which is configured to releasibly hold the shaft 23 and proximal end portion 24 in place during ostium measurement. The luer may be loosened to allow extension or retraction of shaft 23 from guide catheter 30, and then tightened when distal end portion 22 is in a desired position. The guide catheter apparatus and the methods of positioning a tool such as the ostium measuring device into a guide catheter apparatus are described in U.S. patent applications Ser. No. 11/193,020 entitled “Methods and apparatus for treating disorders of the ear, nose and throat”, Ser. No. 11/150,847 entitled “Devices, Systems and Methods Useable for treating Sinusitis” and incorporated herein.
In some embodiments, the distal end portion 22 of the measuring device 20 will further comprise indicia as illustrated in FIG. 3b. FIG. 3b shows a distal end portion 22 with alternating stripes of contrasting colors, optically transparent and opaque material, and/or radio-opaque and radio-transparent regions 28a, 28b, 28c, 28d, 28e and 28f, each region having a unique indicia, number or other alphanumeric symbol 34 which represents a certain distance from the atraumatic tip 25 of distal end portion 22. The indicia 34 are readable by endoscopic and/or fluoroscopic or x-ray techniques. When the indicia 34 are numerical, the number may represent the distance in millimeters each stripe 28a 28b etc. is from the tip of the distal end of the measuring device. Having indicia 34 on the stripes 28 is beneficial when it is necessary to place a large amount of curvature on the distal end portion 22 when making an ostium measurement. By adding numbers 34 to the striped portions 28a, 28b, 28c, 28d, etc., of the distal end portion 22 which correlate to a predetermined distance of the measuring device 20, the user is able to quickly determine the diameter of an ostium. Alternatively, the indicia may directly identify the values of the widths of the stripes that they occur on.
FIGS. 4a-c illustrate further embodiments of a distal portion of an ostium measuring device 40 shown placed within a target ostium 1014 in accordance with the invention. The ostium measuring device 40 shown in FIGS. 4a-c comprises a distal end portion 42 as well as a shaft and a proximal end portion (not shown). The distal end portion 42 has a tapered mandrel portion 44. The measuring device 40 further comprises an atraumatic tip 46 at the smaller end 48 of the tapered mandrel portion 44. The diameter of the atraumatic tip 46 is small enough to fit into the target ostium, smaller end portion 48 first, allowing the tapered mandrel 44 to move through the ostium until the outer circumference of the distal end portion 42 of the measuring device 40 fits snuggly in the ostium 1014.
The tapered mandrel portion 44 may further comprise visually contrasting and/or radio-opaque 50 and alternating (in contrast, or radio-transparent) markings 52 to help navigate the ostium measuring device 40 by visual techniques such as endoscopy, fluoroscopy and other x-ray techniques. Adjacent markings or stripes 50, 52 are separated by a boundary or interface 54 of known or pre-determined diameter. The markings 50, 52 allow the user to determine the size of the ostium 1014 by counting the number of stripes 50, 52 and portions thereof on the measuring device 40 which are able to move through the ostium 1014 as shown in FIG. 4a. For example, the interface 54a in FIG. 4a between alternating stripes 50, 52 may represent a predetermined outer diameter of 1 mm at that particular point on the mandrel portion 44 of the measuring device 40. Interfaces 54b, 54c respectively indicate increases in the outer diameter of the device 40 in similar increments of 1 mm (i.e. 2 mm, 3 mm etc.) or by 0.5 mm increments (i.e. 1.5 mm, 2.0 mm), or other incremental increases in diameter. Thus by counting the stripes 50, 52 the user can determine at what point the ostium 1014 has a similar diameter and circumference as the outer diameter of the ostium measuring device 40. The interfaces 54 may represent smaller or larger incremental changes in the outer diameters of the measuring device depending on the ostium to be measured.
FIG. 4b shows one embodiment of a measuring device 40 which further comprises indicia or alphanumeric symbols 55 on the stripes 50, 52 of the tapered mandrel portion 44. The indicia 55 may indicate the outer diameter of the ostium measuring device at that particular position (or the diameter at an adjacent boundary 54) along the longitudinal axis of the distal end portion 42 of the measuring device 40, thus allowing the user to identify the diameter of the ostium in relation to a “close fit” position with the measuring device 40. In some embodiments the numerical indicia are in increments of 0.5 mm (i.e. 0.5, 1.0 mm, 1.5 mm etc.) indicating the diameter of the tapered mandrel portion 44 at that particular point on the length of the device as shown in FIG. 4b. Other embodiments may involve having indicia 55 which indicates the circumference of the measuring device at specific positions, such as the interface or boundaries 54 between adjacent stripes 50, 52, allowing the circumference of the target ostium 1014 to be determined easily by the user. It is noted that in all the cases described herein, the placement of the measuring device can be aided by the use of a guide catheter.
In some embodiments, the ostium measuring devices of the present invention may comprise a lumen or channel 56 extending therethrough as illustrated in FIG. 4c. The ostium measuring device 40 shown in FIG. 4c further comprises an opening (not shown) at the atraumatic tip 46, which communicates with lumen 56 and is large enough for a guidewire 58 to be inserted in the lumen 56 of the device and through the opening in the atraumatic tip 46. This allows the ostium measuring device 40 to be conveniently inserted in the target ostium 1014 during a surgical procedure to check or measure the size of the ostium to determine if the ostium needs to be enlarged or is of an adequate size to permit sufficient drainage from the sinus associated with the target ostium. Additionally or alternatively, the measuring device 40 allows a guidewire to be steered to the target ostium. That is, measuring device 40, when provide with a lumen to insert a guidewire therethrough, can function like a guide catheter. The distal end of measuring device can be placed just outside of a target sinus ostium and the guidewire can be pushed through the measuring device, through the target sinus ostium and into the sinus. Alternatively, the distal end of the measuring device can be place in the sinus ostium and then the guidewire can be fed into the sinus, through the measuring device. In this regard, some embodiments further comprise a slot (not shown in FIG. 4c) down a portion or all of the lumen to allow a guidewire 58 or other elongate device to be extracted laterally from all or a portion of the lumen 58 of the ostium measuring device 40.
Referring now to FIGS. 5a-5c, illustrations of another embodiment of an ostium measuring device 60 in accordance with the invention are shown. The ostium measuring device 60 shown in FIGS. 5a-5c comprises a distal end portion 62 and a proximal end portion 64. The distal end portion 62 has a telescoping or extensible measurement portion 66 for measuring the size of a target ostium 1014 and a flexible or malleable shaft portion 68 interconnecting the proximal end portion 64 and distal end portion 62. The telescoping measurement portion 66 comprises a central housing 70 and a plurality of interfitting extension elements or features 72a, 72b, 72c with incrementally decreasing profiles, so that the features are nestable within one another. That is, the extension elements 72 have interior spaces configured to receive the next adjacent extension element therein, except for the outermost elements 72c. This allows the extension elements to collapse or retract within one another towards the central housing 70 of the telescoping measurement portion of the device 60, and, alternately, to extend outward from the collapsed configuration to an extended configuration from the housing 70. Extension can be continuous, so that continuously varying diametrical distances can be achieved by the extending elements. Elements 72a, 72b, 72c are hollow and are configured such that, in a retracted position, feature 72b fits within feature 72a, and feature 72c fits within feature 72b. This arrangement is not limited to three features 72 per side, as more of fewer telescoping features 72 could be provided on each side.
FIG. 5c shows a partial sectional view of device 60 to illustrate the functionality thereof. In the embodiment of FIG. 5c, extension elements 72 are biased toward the fully extended configuration shown in FIG. 5c, by biasing elements 77. As shown, biasing elements 77 are coiled compression springs that extend between the base of a largest extension element 72a and a smallest extension element 72c. However, alternative biasing elements may be employed, such as leaf springs, or other biasing elements. FIG. 5c also illustrates shoulders 72s, or other abutment features provided on extension elements that prevent the extension elements from over-extending and thus separating from an adjacent extension element. The proximal end portion 64 further comprises a handle or handpiece 74 with an adjustment knob 76 configured to adjust the configuration/positions of extension elements 72 of the telescoping measurement portion 66 by mechanical control through the longitudinal axis of the handle 74, flexible shaft 68 and central housing 70. That is, shaft 79 is connected to control knob 76 at a proximal end of the shaft, and is connected to rotor 75 at a distal end of the shaft. Wires or tethers 73 interconnect the outermost extension elements 72c with rotor 73 on opposite sides of the rotor from the center of the rotor. In this way, when an operator rotates actuator 76 while maintaining handle 74 fixed, this rotates shaft 79 and rotor 75 which draws tethers 73 toward the central housing 70, thereby retracting extension elements 72 toward the central housing. Reverse rotation of the actuator 76 removes tension from tethers 73, allowing biasing elements 77 to drive extension elements outwardly from the central housing 70. Thus, rotatable adjustment knob 76 is mechanically coupled to extension elements 72a, 72b, 72c, such that rotation of knob 76 in one direction results in extension of extension elements 72a, 72b, 72c from housing 70, while rotation of knob 76 in the opposite direction results in collapse or retraction of extension elements 72a, 72b, 72c into or towards housing 70.
FIG. 5d is a sectional view of a device 60 (viewed from the distal end of the device) having an alternative mechanism for controlling extension and retraction. In this embodiment, racks 82 are provided to connect with the outermost extension elements 72c, at one end of each respective rack 82. The opposite end portions of racks 82 are meshed with pinion 84 that is mounted on shaft 79. Thus, rotation of actuator 76 in one direction drives racks 82, via pinion 84 in directions away from central housing 70, thereby extending elements 72, and rotation of actuator 76 in the opposite direction drives racks 82, via pinion 84, in directions toward the central housing 70, thereby retracting elements 72.
Extension elements 72a, 72b, 72c may be tapered in shape such that the outside diameter of the inner or base portion of element 72b is greater than the inside diameter of the outer or top portion of underlying element 72a, so that when fully extended, the base portion of element 72b does not extend past or exit the top portion of element 72a. Similarly, the outside diameter of the inner or base portion of element 72c may be greater than the inside diameter of the outer or top portion of underlying element 72b, so that when fully extended, the base portion of element 72c is prevented from extending past or exiting the top portion of element 72c. 
Ostium measuring device 60 comprises two groups of individual extension elements 72a, 72b, 72c, with the outermost extension elements 72c having the smallest dimensions (e.g., diameter), and having the largest distance from the central housing 70 when the two groups of extension elements 72a, 72b, 72c are fully extended from housing 70. The distal end portion 62 of the ostium measuring device 60 has a size or diameter, when the individual extension elements are contracted, that is smaller than the size or diameter of the target ostium 1014, allowing the distal end portion 62 to be placed within the target ostium. Once the distal end portion 62 is positioned in the target ostium, the user rotates the adjustment knob 76 to extend the extension elements 72a, 72b, 72c until the outermost extension elements 72c, 72c′ contact the wall of the ostium 1014. In at least one embodiment, elements/features 72 are extended until they can no longer be extended, as the force of extension is insufficient to dilate the ostium, so the most extended position of the elements 72 reliably measures the diameter of the ostium.
The knob 76 may further include a marking or arrow 78 adjacent to the handpiece 74, to allow the user to correlate the position of the knob 76 to the handpiece 74 while turning the knob 76 to change the distance between the outmost extending features 72c, 72c′. The handpiece 74 may further include indicia 80 adjacent to the adjustment knob 76 such that when the arrow 78 on the knob 76 points to or is adjacent to a particular number or indicia 80, (i.e. 2 mm) the indicia corresponds to the distance between the outmost extending features 72c, 72c′, thus giving the diameter of the target ostium 1014. For example, FIG. 5b shows indicia of 1.0, 2.0 and 3.0 on the handpiece, relating to a distance between the outermost surfaces of the outermost extension elements 72c, 72c′ of 1 mm, 2 mm and 3 mm, respectively.
The indicia 80 on the handpiece 74 may vary depending on the size of the target ostium 1014 to be measured and/or the configuration of the features 72. Some indicia 80 may be in increments of about 0.5 mm, for example, while other devices may have the indicia in increments of about 1.0 mm, or 0.25 mm, or other increment, for example. The number of indicia 80 on the handpiece 74 may also vary depending on the range of variable distance the outermost extending features 72c, 72c′ can achieve. For example if the largest distance between the outermost extending features is 5 mm, their may be 6 numerical indicia 80 on the handpiece 74, e.g. 0.0, 1.0, 2.0, 3.0, 4.0 and 5.0 mm, as well as, optionally, other indicia or gradations therebetween.
The distal end portion 62 may further comprise radio-opaque markings (not shown) to allow visual navigation to locate the target ostium 1014 with the ostium measuring device 60 by fluoroscopic or other x-ray techniques. The radio-opaque markings may be on the central housing 70 or at least one of the individual extending features 72a, 72b, 72c. Location of the target ostium 1014 may be carried out by endoscopic means alone. Alternatively, or in addition thereto, fluoroscopic visualization may be used to supplement or replace endoscopic visualization. Accordingly when only endoscopic visualization is used, this may eliminate the need for radio-opaque markings in some instances. When used, radio-opaque markings on the two outermost extending features 72c, help the user to locate the target ostium 1014 and also to visualize, by fluoroscopy, when the walls of the target ostium 1014 are in contact with the outermost extending features 72c, 72c′. The telescoping ostium measuring devices 60 as with other embodiments of the invention are capable of measuring elliptical ostia by obtaining both the major and minor diameters of an oval target ostium.
The measuring device 60 may include flexible or malleable portions as well as semi-rigid or rigid portions. Such portions of the ostium measuring device 60 may be made from materials such as metallic tubes, rods (e.g. rods embedded in a shaft or wire. Suitable biocompatible material(s) that can be used for construction of an ostium measuring device include but are not limited to metals e.g. malleable stainless steel, fully annealed stainless steel, copper, aluminum, titanium, nickel-titanium alloy (e.g., Nitinol), etc.; polymers e.g. Pebax, PEEK, Nylon, polyethylene, etc, as described above.
Turning now to FIG. 6, there is shown is a flow chart of one embodiment 100 of the methods for measuring an ostium of a patient with an ostium measuring device in accordance with the invention. This method embodiment comprises; introducing an ostium measuring device within a patient 110, locating a target ostium with the ostium measuring device 120, positioning the ostium measuring device near or into the target ostium 130, and determining whether or not the distal end of the ostium measuring device is optimally positioned 140. For the devices shown in FIGS. 2, 4 and 5, the device is optimally placed when the fit between the device and the ostium is snug, but not excessively tight, so that the device becomes stuck or “hung up” on the ostium. For the device in FIG. 3, the device is optimally placed when the ribbon is flush against the plane of the ostium, somewhat like measuring with a measuring tape. If the distal end is optimally positioned in event 140, determining the size of the ostium by comparing the ostium to the ostium measuring device 150 is carried out, followed by removing the ostium measuring device from the patient 160. If the distal end is not optimally positioned in event 140, adjusting the distal end may be carried out, followed by repeating event 140. Alternatively, when the distal end is not optimally positioned, exchanging the ostium measuring device 180 may occur, followed by repeating of events 110 through 140.
Introducing the ostium measuring device into a patient 110 involves inserting the measuring device into an opening such as the throat, an ear or a nostril of a patient. The ostium measuring devices of the instant invention, as described above, comprise a distal end portion and proximal end portion, the distal end portion configured to easily fit into the opening of an ear, nostril or the throat. When the target ostium is a sinus ostium, the distal end portion of the ostium measuring device is inserted into a nostril either independently or with the aid of a secondary device such a guidewire or an illuminating guidewire as described in co-pending commonly assigned application Ser. No. 11/522,497 filed Sep. 15, 2006 and titled “Methods and Devices for Facilitating Visualization in a Surgical Environment”. Additionally, or alternatively, a sinus guide (e.g., guide catheter) may be used to facilitate placement of the measuring device close to the ostium of interest. application Ser. No. 11/522,497 is hereby incorporated herein, in its entirety, by reference thereto. In many embodiments of the invention introducing the ostium measuring device further comprises connecting a handpiece or guide catheter to the proximal end portion of the measuring device. A handpiece or guide catheter can aid the user in introducing the distal end portion of the measuring device into the patient as well as help mediate the advancement of the device through regions of the patient's body, such as the ear canal or nasal passageway.
Locating the target ostium 120 with the ostium measuring device may be performed with the use of visual navigation techniques or by physical familiarity of an ostium with the ostium measuring device by the user, with no need for any visualization equipment. When the method for measuring an ostium includes utilizing visual navigation equipment, the target ostium can be located by endoscopy equipment, fluoroscopy systems, X-ray imaging, image guided surgery (IGS) systems, or other visualization systems. Embodiments which utilize fluoroscopy or other x-ray techniques for locating the target ostium may further comprise visualizing at least one radio-opaque marker positioned on the distal end portion of the ostium measuring device as described above. Locating the target ostium in certain embodiments, such as when using the device shown in FIG. 4c, involve having the ostium measuring device connected to a guidewire already inserted through the target ostium.
Positioning the ostium measuring device correctly with relation to the target ostium 130 to make an ostium measurement, will vary depending on which embodiment of the ostium measuring device is being used. For embodiments such as those illustrated in FIGS. 2a, 2b, 4a-c, 5a and 5c, positioning the ostium measuring device comprises inserting a portion of the distal end portion of the measuring device into the target ostium. When the ostium measuring device comprises a spherical shaped tip on the distal end portion of the device as illustrated in FIGS. 2a and 2b, the device is correctly positioned 130 when the spherical portion of the device matches the diameter (e.g., contacts or closely approximates the walls) of the target ostium. For those embodiments where the distal end portion is a tapered mandrel, such as is shown in FIGS. 4a-c, positioning the measuring device correctly comprises inserting the tapered mandrel into the target ostium until the outer circumference of the distal end portion of the device contacts (or closely approximates) the walls of the target ostium. In the case of a telescoping measuring portion on the distal end portion, as shown in FIGS. 5a and 5b, the user places the central housing on the distal end portion within the target ostium and then, by adjusting the knob on the handpiece of the measuring device, extends the telescoping features of the telescoping portion until the outermost extending features touch (or closely approximate) the walls of the ositum.
In event 140, a decision is made by the surgeon as to whether or not the distal end of the ostium measuring device is optimally positioned with respect to the ostium to be measured. If yes, events 150 and 160 are carried out. If not, event 170 is carried out, followed by repetition of event 140. Alternatively, in certain embodiments event 180 is carried out, followed by repetition of events 110 through 140.
When the ostium measuring device comprises a spherical shaped tip on the distal end portion of the device as in the embodiments of FIG. 2a and FIG. 2b, the spherical portion of the distal end portion may easily slide through the target ostium, indicating that the ostium is larger than the diameter of the spherical portion. Or, the spherical portion may not fit through the target ostium, indicating the ostium is smaller than the diameter of spherical tip of the device. In this situation, exchanging the measuring device 180 is carried out, and the ostium measuring device is removed, and a new ostium measuring device is inserted, and steps 110 through 140 are repeated.
When the ostium measuring device includes a tapered mandrel distal end portion as shown in FIG. 4a through 4c, or a curvilinear distal end portion as shown in FIG. 3a and FIG. 3b, once the distal end portion is positioned in event 130, the determination of event 140 involves determination as to whether or not the distal end portion needs adjusting in step 170 by further extending or advancing, or alternatively withdrawing or retracting, the distal end portion, with respect to the ostium to be measured. Event 140 is then repeated after the adjusting.
In the embodiments of FIG. 5a and FIG. 5b, if the outermost telescoping features 72c, 72c′ are not in contact with (or in sufficiently close approximation to, in the opinion of the surgeon) the ostium in event 140, an adjustment is made in event 170 by turning the knob on the handpiece to adjust the position of features 72c, 72c′. Event 140 is then repeated after the adjusting.
In event 150, determining or measuring the target ostium size is carried out. In the embodiments of FIG. 2a and FIG. 2b, when the spherical portion of the measuring device fits snugly into (or closely approximates) the target ostium, the diameter or size of the ostium is determined by measuring or verifying the diameter of the spherical distal end. For example, a 3.5 mm sphere may be passable through the ostium, while a 4 mm sphere may not be able to be passed therethrough. In such a case, a surgeon may make a judgment call as to whether the ostium is closer to 3.5 mm or 4 mm. Alternatively, the surgeon may interpolate the measurement to something in between 3.5 mm and 4 mm based on the surgeon's visualization of the process and judgment. Further alternatively, another set of devices 10 having smaller incremental size variations between 3.5 mm and 4 mm may be resorted to.
In embodiments of FIG. 3a, FIG. 3b and FIG. 4a through 4c, when the mandrel shaped or curvilinear distal end portion fits snugly within or over the ostium, the ostium diameter is measured by reading the indicia on the distal end portion, or by counting the radio-opaque and radio-transparent bands on the distal end portion. Radio-opaque markings on the distal end portions can be counted by the user and the diameter of the ostium can be determined by comparing the distance of the portion of the measuring device which crosses or overlays the diameter of the target ostium. For target ostia which have an oval shape, the ostium measuring device of FIGS. 3a and 3b can be oriented approximately 90 degrees across the ostium and another measurement can be taken, allowing both the major and minor diameters of the ostium to be determined.
In embodiments of FIG. 5a and FIG. 5b, when extensible features 72c, 72c′ are in contact with the ostium, measurement is made by reading the indicia on the handpiece that are adjacent to the arrow on the adjustable knob. Oval ostia can be measured in similar fashion to that described above, e.g., by rotation of the distal end portion by about ninety degrees and taking another measurement.
Removing the ostium measuring device 150 from the patient comprises withdrawing the distal end portion and shaft of the measuring device from the ostium and nasal cavity through the patient's nostril.
While the present invention has been described with reference to the specific embodiments thereof, it should be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process step or steps, to the objective, spirit and scope of the present invention. All such modifications are intended to be within the scope of the claims appended hereto.

## Claims

1. A method for measuring the size of and treating a paranasal sinus ostium of a patient, said method comprising the steps of:
advancing a guidewire through a targeted paranasal sinus ostium in a patient;
inserting a paranasal sinus ostium measuring device into the patient over the guidewire, wherein the measuring device comprises:
an elongate, at least partially rigid shaft having a proximal end and a distal end;
an enlarged distal end portion at the distal end of the shaft; and
at least one preformed bend in the shaft;

locating the targeted paranasal sinus ostium with the distal end portion of the paranasal sinus ostium measuring device;
positioning the distal end portion of the paranasal sinus ostium measuring device at least partially within or through the targeted paranasal sinus ostium;
determining a diameter of the targeted paranasal sinus ostium using the paranasal sinus ostium measuring device;
withdrawing the paranasal sinus ostium measuring device from within or through the targeted paranasal sinus ostium;
subsequent to withdrawing the paranasal sinus ostium measuring device, selecting a balloon catheter based upon the diameter of the targeted paranasal sinus ostium such that a balloon of the balloon catheter, when inflated within the ostium, fractures, moves or remodels bony structures that surround or are adjacent to the targeted paranasal sinus ostium; and
intra-operatively treating the targeted paranasal sinus ostium with the selected balloon catheter.

2. The method of claim 1, wherein said distal end portion comprises a spherical portion, and wherein determining the diameter includes feeling tactile feedback of the spherical portion passing into the ostium to determine whether an outer diameter of the spherical portion is approximately equal to the diameter of the paranasal sinus ostium.

3. The method of claim 1, where said locating is performed by visual navigation techniques.

4. The method of claim 3 where said visual navigation technique is fluoroscopy.

5. The method of claim 1, wherein said positioning comprises placing the distal end portion of the paranasal sinus ostium measuring device against tissue surrounding the sinus ostium.

6. The method of claim 1, wherein said determining the sinus ostium size comprises visualizing the target sinus ostium and sinus ostium measuring device by fluorometry techniques.

7. The method of claim 1, wherein said determining the ostium size comprises visualizing the target sinus ostium and sinus ostium measuring device by image guided surgery (IGS) systems.

8. The method of claim 1, wherein said determining the sinus ostium size comprises visualizing the target sinus ostium and sinus ostium measuring device by endoscopic visualization.

9. The method of claim 1, wherein said determining the sinus ostium size comprises visualizing an indicator on the sinus ostium measuring device.

10. The method of claim 1, wherein said locating is performed by physical familiarity of a sinus ostium with the sinus ostium measuring device, with no need for any visualization equipment.

11. The method of claim 1, wherein determining the diameter of the paranasal sinus ostium comprises:
advancing the distal end portion of the paranasal sinus ostium measuring device into the sinus ostium, wherein the distal end portion has a smaller distal diameter and a larger proximal diameter;
determining how far the distal end portion can be advanced into or through the ostium; and
determining the diameter of the ostium based on how far the distal end portion of the paranasal sinus ostium measuring device is advanced into the sinus ostium.

12. The method of claim 1, wherein said determining the paranasal sinus ostium diameter comprises providing a radio-opaque marker on the distal end portion of the sinus ostium measuring device.

13. The method of claim 1, wherein the paranasal sinus ostium measurement device is initially inserted through a nostril of the patient and then advanced to a sinus ostium.

14. The method of claim 1, wherein the enlarged distal end portion slides easily through the paranasal sinus ostium, the method further comprising:
removing the measurement device from the patient;
inserting a second measurement device into the patient; and

repeating the locating, positioning and measuring steps with the second measurement device.