# Patent

## Title
Catheters with non-removable guide members useable for treatment of sinusitis

## Abstract

Balloon catheter, guide catheter and method for dilating openings in paranasal sinuses. A non-removable guide member (e.g., guidewire) extends from the distal end of the balloon catheter. The non-removable guide member initially passes through the opening of the paranasal sinus and is followed by the catheter body on which the balloon is mounted. The balloon is then inflated causing dilation of the opening of the paranasal sinus. In some embodiments, the non-removable guide member may be shapeable so that the operator may place the non-removable guide member in a desired shape prior to insertion of the balloon catheter. In some embodiments, the length of the non-removable guide member may be adjustable such that the operator may adjust the length of the non-removable guide member prior to insertion of the balloon catheter.

## Background
RELATED APPLICATION
This application is a continuation-in-part of U.S. patent application Ser. No. 11/150,847 entitled “Devices, Systems and Methods Useable for Treating Sinusitis” filed Jun. 10, 2005, issued Sep. 9, 2010 as U.S. Pat. No. 7,803,150, the entire disclosure of which is expressly incorporated herein by reference. Additionally, this application is a continuation-in- part of and copendinq U.S. patent application Ser. No. 11/193,020 entitled “Methods and Apparatus for Treating Disorders of the Ear, Nose and Throat” filed on Jul. 29, 2005.


FIELD OF THE INVENTION
The present invention relates generally to medical devices and methods and more particularly to minimally invasive, devices, systems and methods for treating sinusitis and other ear, nose & throat disorders.
BACKGROUND
Balloon angioplasty catheters have been used to treat cardiovascular disorders for many years. In general, balloon angioplasty catheters of the prior art have included over-the-wire catheters, which ride over a separate guide wire, which represent the majority of balloon catheters, fixed-wire catheters, which combine the balloon catheter and guide wire into one device, and rapid exchange catheters, which are essentially over-the-wire type catheters with short guidewire lumens that allow the catheter to be exchanged without the use of an extension wire.
The fixed wire balloon angioplasty catheters of the prior art have typically ranged in length from about 120 cm to about 150 cm and have had balloon dimensions and flexural properties that were suitable for performing balloon angioplasty procedures in coronary or peripheral blood vessels. Examples of commercially available fixed-wire balloon angioplasty catheters include the AceTM balloon catheters (Boston Scientific, Inc., Natick, Mass.).
More recently, procedures have been developed wherein balloon catheters are used to dilate the ostia (or other openings) of paranasal sinuses for the treatment of disorders such as sinusitis. In these procedures, a balloon catheter or other dilator catheter is advanced transnasally into an opening of a paranasal sinus and used to dilate that opening, thereby improving drainage and ventilation of the affected sinus. In some embodiments, a guide catheter is initially inserted into the nose, a guidewire is then advanced through the guide catheter and the balloon catheter is then advanced over the guidewire. In other embodiments, as described in parent application U.S. patent application Ser. No. 11/150,847, issued as U.S. Pat. No. 7,803,150, the balloon catheter may be equipped with a non-removable guide member that extends from its distal end and is advanceable through the ostium of the paranasal sinus ahead of the catheter shaft and balloon. The provision of such non-removable guide member extending from the distal end of the balloon catheter eliminates the need for use of a separate guidewire, thereby simplifying the procedure, shortening the procedure time, reducing the need for an assistant, and decreasing the amount of radiation exposure to the patient and operator due to use of fluoroscopy.
There remains a need in the art for further development and refinement of balloon catheters (and other dilator devices) that have non-removable guide members for use in dilating the ostia of paranasal sinuses.
SUMMARY OF THE INVENTION
In accordance with the present invention, there is provided a balloon catheter device for dilating an opening of a paranasal sinus in a human or animal subject. In general, this balloon catheter device comprises; (a) a catheter shaft having a proximal end and a distal end, (b) a non-compliant or semi-compliant balloon (or other suitable dilator) mounted on the catheter shaft, such balloon being positionable within the opening of the paranasal sinus while in a non-inflated state and thereafter inflatable to an inflated state such that it will cause dilation of the opening of the paranasal sinus, (c) at least one position indicating element useable to determine when the balloon is positioned within the opening of the paranasal sinus and (d) a non-removable guide member, at least a portion of which extends from the distal end of the catheter shaft, said non-removable guide member having a limited range of axial movement or no movement relative to the catheter shaft, said non-removable guide member being advanceable through the opening of the paranasal sinus ahead of the catheter shaft. Such balloon catheter device has a length less than about 20 cm. In some embodiments, the guide member may be attached to the catheter device in a substantially fixed position. In other embodiments, the guide member may be attached to the catheter device in a manner that allows the guide member to undergo rotational movement and/or some limited range of longitudinal movement (e.g., axial translation). In some embodiments the guide member may extend through all or part of the catheter shaft, with only a portion of the guide member protruding beyond the distal end of the catheter shaft. In other embodiments, the guide member may be attached to the distal end of the catheter shaft such that little or no part of the guide member actually extends into the catheter body. In some embodiments, the catheter shaft may be formed of plastic while in other embodiments the catheter shaft may be formed of metal (e.g., hypotube). In some embodiments, the catheter device may be used in conjunction with a straight or curved guide catheter. In other embodiments, the catheter device may be inserted into the opening of a paranasal sinus without the use of a guide catheter.
Further in accordance with the invention there is provided a guide catheter through which the above-summarized balloon catheter device may be inserted. Such guide catheter may comprise an outer metal tube and a plastic tube that extends coaxially through the lumen of the metal tube with a distal portion of the plastic tube extending out of and beyond the distal end of the metal tube. The portion of the plastic tube that extends beyond the distal end of the metal tube may be straight or curved. In some embodiments, an outer cover may extend over all or part of the outer surface of the guide catheter and such outer cover may serve to smooth the transition between the distal end of the metal tube and the adjacent surface of the protruding portion of the plastic tube. In some embodiments, an inner liner (e.g., a lubricious liner) may line all or part of the lumen of the inner plastic tube.
Still further in accordance with the present invention, there is provided a method for dilating an opening of a paransal sinus in a human or animal subject. This method generally comprises the steps of; (A) providing a balloon catheter that has a non-removable guide member that extends from its distal end, (B) trans-nasally inserting the balloon catheter and causing at least part of the non-removable guide member to pass through an opening of the paranasal sinus, (C) moving the balloon catheter to a location where the balloon is positioned within the opening of the paranasal sinus and (D) inflating the balloon to cause dilation of the opening of the paranasal sinus.
Further aspects, details and embodiments of the present invention will be understood by those of skill in the art upon reading the following detailed description of the invention and the accompanying drawings.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 shows a side view of a guide catheter/non-removable wire balloon catheter system of the present invention.
FIG. 1A is a side view of the non-removable wire balloon catheter shown in FIG. 1.
FIG. 1B is a side view of the guide catheter shown in FIG. 1.
FIG. 2 is a cross sectional view through the longitudinal axis of the non-removable wire balloon catheter of FIG. 1A.
FIG. 2A is a cross sectional view through line 2A-2A of FIG. 2.
FIG. 2B is a cross sectional view through line 2B-2B of FIG. 2.
FIG. 2C is a cross sectional view through line 2C-2C of FIG. 2.
FIG. 2D is a cross sectional view through line 2D-2D of FIG. 2.
FIG. 2E is cross sectional view through the longitudinal axis of an alternative embodiment of a non-removable wire balloon catheter of the present invention.
FIG. 2F is cross sectional view through the longitudinal axis of yet another alternative embodiment of a non-removable wire balloon catheter of the present invention.
FIG. 3 is a partially sectioned side view of the non-removable guidewire component included in the balloon catheters shown of FIGS. 1A, 2E and 2F.
FIG. 4 is a partial longitudinal sectional view through a balloon catheter of the present invention showing an alternative construction at the location where the proximal end of the balloon is mounted on the outer catheter shaft.
FIG. 5A is another side view of the guide catheter of FIG. 1B, with the catheter rotated 90 degrees from that seen in FIG. 1B.
FIG. 5B is a cross sectional view through line 5C-5C of FIG. 5A.
FIG. 5C is an enlarged view of region 5C of FIG. 5B.
FIG. 5D is an enlarged cross sectional view through Line 5D-5D of FIG. 5B.
FIG. 5E is an enlarged view of region 5E of FIG. 5B.
FIG. 5F is an enlarged view of region 5F of FIG. 1B.
FIG. 5G is a cross sectional view through line 5G of FIG. 5A.
FIGS. 6A and 6B are schematic diagrams showing a device and method for forming the curve in the guide catheter of FIG. 1B.
FIGS. 7A-7E show steps in a method for using the system of FIG. 1 to enlarge the ostium of a maxillary sinus in a human subject.
FIG. 8 is a cross sectional view through a longitudinal axis of another embodiment of a non-removable wire balloon catheter, having a curved hypotube shaft.
FIG. 8A is an enlarged view of a distal portion of FIG. 8.
FIG. 9 is a cross sectional view through a longitudinal axis of another embodiment of a non-removable wire balloon catheter, having a straight hypotube shaft.
FIG. 9A is an enlarged view of a distal portion of FIG. 9.



DETAILED DESCRIPTION
The following detailed description and the accompanying drawings are intended to describe some, but not necessarily all, examples or embodiments of the invention. The contents of this detailed description and the accompanying drawings do not limit the scope of the invention in any way.
The term “opening of a paranasal sinus” as used herein shall, unless otherwise stated, include any and all trans-nasally accessible opening in a paranasal sinus or air cell including but not limited to; natural ostia, surgically altered natural ostia, surgically created openings, antrostomy openings, ostiotomy openings, burr holes, drilled holes, ethmoidectomy openings, natural or man made passageways, etc.
The term “diagnostic or therapeutic substance” as used herein is to be broadly construed to include any feasible drugs, prodrugs, proteins, gene therapy preparations, cells, diagnostic agents, contrast or imaging agents, biologicals, etc. Such substances may be in bound or free form, liquid or solid, colloid or other suspension, solution or may be in the form of a gas or other fluid or nan-fluid. For example, in some applications where it is desired to treat or prevent a microbial infection, the substance delivered may comprise pharmaceutically acceptable salt or dosage form of an antimicrobial agent (e.g., antibiotic, antiviral, antiparasitic, antifungal, etc.), a corticosteroid or other anti-inflammatory (e.g., an NSAID), a decongestant (e.g., vasoconstrictor), a mucous thinning agent (e.g., an expectorant or mucolytic), an agent that prevents of modifies an allergic response (e.g., an antihistamine, cytokine inhibitor, leucotriene inhibitor, IgE inhibitor, immunomodulator), etc. Other non-limiting examples of diagnostic or therapeutic substances that may be useable in this invention are described in copending U.S. patent application Ser. No. 10/912,578 entitled Implantable Devices and Methods for Delivering Drugs and Other Substances to Treat Sinusitis and Other Disorders filed on Aug. 4, 2004, issued as U.S. Pat. No. 7,361,168 on Apr. 22, 2008, the entire disclosure of which is expressly incorporated herein by reference.
The term “nasal cavity” as used herein shall, unless otherwise stated, be broadly construed to include any cavity that is present in the anatomical structures of the nasal region including the nostrils and paranasal sinuses.
The term “trans-nasal” as used herein shall mean through a nostril.
In general, FIGS. 1-5H show catheters devices of the present invention, FIGS. 6A and 6B show a device and method for forming a curve in a guide catheter device of the present invention and FIGS. 7A-7E show one embodiment of a method for using catheter devices of the present invention to treat sinusitis in a human subject.
With reference to FIGS. 1-2D, one embodiment of a system 10 of the present invention comprises a non-removable wire balloon catheter 12 and a guide catheter 14. Although shown and described as a system it is to be appreciated that the non-removable wire balloon catheter 12 and guide catheter 14 need not necessarily be used in combination, but rather may also be used independently of one another.
Non-Removable Wire Balloon Catheter
The embodiment of the non-removable wire balloon catheter 12 shown in FIGS. 1-2E comprises an elongate, flexible catheter shaft 16 having a balloon 18 mounted thereon. A proximal Luer hub 20 is attached to the proximal end of the catheter shaft 16. An inflation device (not shown) may be attached to the Luer hub 20 and used to inflate and deflate the balloon 18. A non-removable guide member 22 extends out of and beyond the distal end DE of the catheter shaft 16.
In one preferred embodiment for adult applications, balloon catheter 12 has an overall length of approximately 43.5 cm and its shaft 16 has an outer diameter of about 0.058 inches.
As seen in FIG. 2, in this embodiment, the catheter shaft 16 comprises an outer tube 30 which extends from the hub 20 through the proximal end 32 of balloon 18. An inner tube 34 is positioned coaxially within the outer tube 30 and extends from the mid-region of the outer tube 30 and through the distal end of the balloon 36. As shown, the proximal end of the balloon 32 is attached by adhesive, thermal bonding or other suitable means to the outer surface of the outer tube 30 and the distal end of the balloon 36 is attached by adhesive, thermal bonding or other suitable means to the outer surface of the inner tube 34. The balloon has a cylindrical sidewall with tapered portions adjacent to the proximal end 32 and distal end 36. The length of the cylindrical portion of the balloon 18 is referred to herein as the balloon's working length WL. The working length WL of balloon 18 may, in some embodiments, range from 4 mm to 35 mm. In one preferred embodiment, the working length of the balloon is around 16 mm+/−1 mm. In another preferred embodiment, the working length of the balloon is around 24 mm+/−1 mm. Balloon 18 may be inflated to a suitable working pressure of around 12 to 16 atmospheres.
Optionally, position indicators, such as radiopaque markers 38, 40 may be mounted on the inner tube 34 within the balloon 18 to mark the locations of the proximal and distal ends of the working length WL. Balloon 18 may be coated with one or more balloon coatings including, but not limited to puncture resistance coating, abrasion resistance coating, anti-tack coating, lubricous, hydrophilic, etc. In a particular embodiment, balloon 18 is made of PET of a wall thickness around 0.001 inches coated by a 0.001 inch thick polyurethane coating with a tensile strength of 12,000 to 16,000 psi and a burst pressure of more than 16 atmospheres. In some embodiments, a portion of the non-removable guide member 22 may extend through the balloon 18 and that portion of the non-removable guide member 22 may be radiopaque or otherwise radiographically distinguishable from the rest of the non-removable guide member 22 so as to indicate the position of balloon 18 as well as the position of the non-removable guide member distal end.
As seen in FIGS. 2 and 3, the non-removable guide member 22 of this embodiment extends fully through the catheter shaft 16 such that only a portion of this guide member 22 protrudes beyond the distal end of the catheter shaft 16. The guide member 22 is constructed to impart differing degrees of stiffness to different regions of the catheter shaft 16. In this regard, as may be best appreciated from FIG. 3, the guide member 22 generally comprises a proximal portion or region 60, a middle portion or region 62 and a distal portion or region 64. This guide member 22 is constructed of a core wire 66, an outer coil 68 and an inner coil 70. In some embodiments, the core wire may be of constant diameter over its entire length. However, in the example shown, the core wire 66 has sections of differing diameter and, hence, differing stiffness. In this example, a proximal section 68 of core wire 66 makes up the proximal region 60 of guide member 22 and is of uniform constant diameter, typically in the range of 0.014 mm to 0.038 in some embodiments and of 0.025+/−0.0005 inch in other embodiments. The particular diameter and/or rigidity of this proximal portion or region 60 may be selected to provide sufficient support to the balloon while remaining small enough to reduce shaft profile and inflation and deflation time of the balloon.
Within the middle region 62 of the guide member 22, the core wire 66 has a number of stepped down areas, namely a first tapered section 72, a first constant diameter section 74 of uniform constant diameter (e.g., in the range of 0.006 to 0.012 inches), a second tapered section 76 and a second constant diameter section 78 of uniform constant diameter (e.g., in the range of 0.002 to 0.008 inches). The distal region 78 of constant diameter may have some or all of its length flattened or partially flattened to fine tune the distal flexibility of the guidewire. The guidewire should be very flexible near the proximal end of region 64 to enable the guidewire to conform to the internal contours of the sinus anatomy. In some embodiments, this distal section 80 of the core wire 66 may be flattened (e.g., cut, swaged, etc.) while the remaining portions of the core wire 66 may be substantially round. In embodiments where the distal section 70 of the core wire 66 is flattened, the height of the flat is generally between from about 0.001 inch to about 0.004 inch. Such flattening of the distal section 70 of the core wire 66 accomplishes the purpose of making the distal region 64 more flexible in one plane (e.g., up and down) than in another plane (e.g., side to side), thereby rendering the distal portion 64 more likely to form a smooth curl within the sinus cavity as it is advanced through the sinus opening.
An outer helical coil, such as a stainless steel wire coil, is affixed to the first tapered section 72 within the middle region 62 and extends to the distal tip of the guide member 22. An inner helical coil, platinum/tungsten alloy, is disposed within the outer coil 70 and around part of the distal section 80 of the core wire 66, as shown. This construction forms an atraumatic tip that is sufficiently stiff to pass through the nasal and paranasal anatomy and floppy enough to buckle without causing damage to the nasal and paranasal tissue. The platinum/tungsten alloy provides a radiopaque marker to identify the tip of the non removable guide member 22 when viewed fluoroscopically.
Two design parameters, namely the diameters and/or relative stiffness of the various sections 68, 72, 74, 76, 78, 80 and material of which the core wire 66 is constructed, can be of particular importance in allowing the non-removable guide member 22 to achieve its desired function. In the preferred embodiment, core wire 66 is made of nickel-titanium alloy (Nitinol) which has high elasticity. The high elasticity of the nickel-titanium core wire 66 enables the balloon catheter shaft 16 to pass easily through regions of guide catheter 14 that have sharp bends or curves without kinking of the core wire 66. The constant diameter section 74 is the region where the balloon is located. The diameter of this section should be small enough to avoid creating excessive stiffness which would create resistance when advancing the balloon catheter through the tip of the guide catheter. However, the diameter of region 74 must be large enough to prevent guidewire buckling and support the balloon as the catheter is advanced. Most importantly, the diameter of region 74 and the gradual taper of region 76 must allow the guidewire to bend in a relatively smooth arc without kinking where the non removable guide member 22 exits the distal end of the balloon 18. In one embodiment the optimal diameter of constant diameter section 74 has been determined to be between 0.006 to 0.012 inches. This diameter can be used to develop catheters for various sinus anatomies and locations. For instance, a catheter designed to extend a significant distance out the tip of a relatively straight guide could use a larger diameter. A catheter for use in a shaped guide needs a smaller diameter to reduce resistance through the guide. The length of non-removalable guide member 22 extending out the distal end of the balloon 18 should be long enough to partially define the outline of the sinus cavity when viewed fluoroscopically but not so long that an excessive length of guidewire tip must be advanced into small sinus cavities. In a preferred embodiment, the length is between about 3 cm and about 6 cm.
The proximal end of the outer tube 30 is received within hub 20 and an outer sleeve 44 may be formed about the area where the outer tube 30 enters the hub 20. Labeling may be printed on this sleeve 44 and, optionally, this sleeve 44 may act as a strain relief member.
As seen in FIGS. 2 and 2D, a crimpable member such as a metal hypotube 48 is attached to the proximal end of section 68 of core wire 66 and extends into the hub 20, where it is surrounded by a plastic hypotube cover 50. The hypotube 48 is crimped inwardly so as to frictionally engage and hold the proximal section 68 of core wire 66 within hub 20. As seen in the cross section view of FIG. 2D, the hypotube 48 may be crimped at discrete locations so as to provide flow channels 90 through which balloon inflation fluid may flow.
As shown in FIG. 1A, a short distal marker 116 and a long proximal marker 118 may be formed on the catheter shaft 16. Distal marker 116 and long proximal marker 118 enable the user to determine the relative location of various regions of balloon catheter device 12 relative to the distal tip of guide catheter 14 without requiring the use of fluoroscopy. For example, the distal marker 116 may be approximately 1.5 mm long and long proximal marker 118 may be approximately 20 mm long. Also, the distal end of distal marker 116 may be located approximately 127 mm from the distal tip of guide member 22 and the proximal end of long proximal marker 93 may be located approximately 131 mm from the proximal end of the balloon 18. These markers 116, 118 are useable in various ways. For example, as described more fully herebelow, the balloon catheter 12 may be useable in conjunction with a specially sized guide catheter 14 as seen in FIG. 1B. In typical usage, the distal end of the non-removable guide member 22 will be inserted into the proximal Luer hub 108 of guide catheter 14 and the balloon catheter 12 will be advanced through the guide catheter 14. The balloon catheter 12 may be sized relative to the guide catheter 14 such that, when the distal marker 116 is even with and about to enter the proximal end of the Luer hub 108 of guide 14, the distal end DE of non-removable guide member 22 will be even with and about to emerge out of the distal end DE of guide catheter 14. Also, when the proximal end of long proximal marker 118 is even with the Luer hub 108 of guide 14, the end of the balloon 36 will be even with and about to emerge out of the guide catheter 14. Also, when the proximal end of long proximal marker 118 is even with and about to enter the proximal end of the Luer hub 108 of guide 14, the proximal end of the balloon 32 will be even with the distal end of the guide catheter 14 and the entire balloon 18 will have emerged out of the distal end of the guide catheter 14.
In embodiments where the balloon catheter 12 is to be inserted through a curved guide catheter 14, it may be desirable to design the proximal joinder of the balloon 18 to the catheter shaft 16 in such a way as to minimize the likelihood for snagging or catching of the proximal end 32 of the balloon 18 as the balloon catheter 14 is pulled back through the curved portion of the guide. FIGS. 2E and 2F show alternative embodiments of the balloon catheter 10a, 10b which are designed to accomplish this. Also, FIG. 4 shows an alternative construction of the catheter shaft 16 at the location where the proximal balloon end 32 is affixed to the catheter shaft 16.
The balloon catheter 10a shown in FIG. 2E is the same as that shown in FIG. 2, except that in the catheter 10a of FIG. 2E the balloon 18A is formed in the distal portion of an elongated balloon tube member 90 which extends proximally to a location near the middle of the catheter shaft where it is bonded to outer tube 30. In this manner, the seam between the proximal end of balloon tube member 90 and outer tube 30 is located proximally enough to avoid any passing through (or being retracted through) the curved region of the guide catheter 14.
The balloon catheter 10b shown in FIG. 2F is the same as that shown in FIG. 2 except that in the catheter 10b of FIG. 2F, the outer tube 30 is absent and an elongated balloon tube 92 extends all the way to the proximal end of the catheter body where it is received within the sleeve 44 and is bonded to hypotube 48. In this manner, the catheter body is essentially seamless from the balloon 18n all the way proximal to the hub 20, thereby eliminating any potential for a seam to snag or catch on the curvature in the guide catheter 14.
With reference to FIG. 4, in some embodiments of the catheter device 10 such as that shown in FIGS. 1-2D, a modified outer tube 30a may be used wherein the outer diameter of such outer tube 30a is reduced at the location where the proximal end 32 of the balloon 18 is affixed, thereby providing a smoothed transition and deterring the proximal end 32 of balloon 18 from snagging or catching as it is retracted through a curved guide catheter or the like.
Guide Catheter
An example of the preferred guide catheter 14 is shown in FIGS. 2B and 5A-5G. As shown, the guide catheter 14 comprises an elongate shaft 102. Guide catheter 14 is made of suitable biocompatible materials as described below. The distal portion of the shaft 102 incorporates a curve 101. Various embodiments of guide catheter 14 may be designed with unique curves formed therein to access specific anatomical locations. Or, in some embodiments, the guide catheter shaft 102 may be malleable so that the operator may form the shaft 102 to a desired shape prior to or during the procedure. In another embodiment (not shown), the guide catheter 14 shaft may be straight, without any curvature. Guide catheters 14 having different angles A of curve 101 may be used, for example, to access one or more anatomical regions in the nasal cavity including, but not limited to ostia of various paranasal sinuses.
In the example shown in the drawings, the elongate shaft 102 of the guide catheter 14 is formed of an outer metal tube such as a hypotube 114 having a plastic tube 112 extending coaxially therethrough with a distal portion 100 of the plastic tube 112 protruding out of and beyond the distal end of the hypotube 114, as seen in FIG. 5F. The hypotube in this example is traditional stainless steel hypotube material. However, it will be appreciated that this hypotube 114 element may be formed of any suitable material having the desired stiffness, such as stainless steel, titanium, nickel-titanium alloys (e.g., Nitinol), polymers such as Nylon, etc. The plastic tube 112 formed of suitable material such as Nylon or other thermoplastic. In the embodiment shown, the radius of curvature of the curve 101 is 0.18 inches. In the embodiment shown, the outer diameter of the flared distal end of elongate shaft 102 is 0.113+/−0.003 inches and the length of radiopaque marker is 0.04 inches. The length of atraumatic tip 104 ranges from 0.060 to 0.120 inches. The outer rim of atraumatic tip 104 is radiused. The distal end of outer sleeve 106 is tapered as shown and covers elongate shaft 102. In a preferred embodiment shown, the outer diameter of the distal end of outer sleeve 106 is 0.109+/−0.003 inches.
Optionally, an outer sleeve or cover 106 may be disposed over a portion of the outer surface of hypotube 114 and, in some cases, may extend over at least some of the protruding distal portion 100 of the plastic tube 112, thereby providing a smooth outer surface over the area where the distal end of the hypotube 114 is located. Such outer sleeve or cover 106 may be formed of any suitable material such as Nylon or other heat shrinkable thermoplastic.
Also optionally, an inner liner 111 may extend through and line the wall of the lumen of plastic tube 112. This inner liner 111 may be formed of any suitable material, and preferably a lubricious material, such as polytetrafluoroethylene PTFE or the like.
In a preferred embodiment, guide device 14 is of a smaller outer diameter than has been previously known for transnasal treatment of paranasal sinuses. The construction of the embodiment allows for greater access and less trauma to a larger number of patient's sinuses, particularly the maxillary sinuses. The smaller diameter allows for the use of the guide catheter alongside other instruments, like an endoscope, in the constricted paranasal anatomy. A shorter or more compact tip allows for greater maneuverability in the tortuous and constricted anatomy. The smaller diameter of the guide allows easier, less traumatic passage in the paranasal cavities. For example, it is easier to fit between the nasal septum and the middle turbinate when accessing the sphenoid; easier fit into the middle meatus and between the lateral wall of the middle turbinate and the uncinate process and lamina paprycia when accessing the maxillary, frontal, and ethmoid sinuses; easier to fit in the middle meatus and up into the frontal recess when accessing the frontal sinus. Additionally, the tight/small diameter of the distal curve of the guide allows less damage/trauma to the middle turbinate and uncinate when accessing the maxillary sinus. When the guide is torqued such that the curve of the guide (the plane of the curve) is essentially perpendicular to the middle turbinate and uncinate process, it will be easier to fit a smaller curve in that narrow space between the middle turbinate and the uncinate/infindiubulum. Additionally, when accessing the maxillary sinus, the smaller diameter guide tip (not curvature radius, but actual diameter of the tip) is better able to slip behind the uncinate (or between the uncinate and lateral wall) and then access the maxillary sinus. With a larger guide catheter, it is not uncommon for the surgeon to tease forward the uncinate process because he was not able to slip the bigger guide catheter tip behind the uncinate process. It is especially useful in accessing the maxillary sinus where the guide catheter tip must be advanced in one orientation to pass by the middle turbinate and then rotated to “hook” the distal end around the uncinate process to give access to the maxillary ostium. In the preferred embodiment, the outer cover 106 is made of a length of Nylon 11 tubing with an inner diameter of 0.125+/−0.001 inches and an outer diameter of 0.139+/−0.001 inches. Outer cover 106 substantially surrounds the outer surface of the hypotube and a region of elongate shaft 102 emerging from the distal end of the hypotube after it is fused/laminated to these underlying surfaces. The final diameter of the shaft over the hypo tube region is 0.134+/−0.003′′. This embodiment comprising outer cover 106 is especially useful for providing an outer lubricious surface on guide device 14, for improving joint integrity between the hypotube and elongate shaft 102, and creating a smooth transition between the distal portion of elongate shaft 102 and the distal end of the hypotube. The proximal end of guide device 14 comprises a hub 108. In the embodiment shown, hub 108 is a female Luer hub. The portion of outer cover 106 extending beyond the distal end of hub 108 is covered with a length of label tubing 110 as shown. The length of label tubing 110 may range from 0.5 inches to 1 inch. In an embodiment where the guide catheter 14 has a curve 101 of 110 degrees and is intended for use in accessing a maxillary sinus, the label tubing 110 may be labeled with the code “M-110”, wherein the “M” stands for maxillary sinus and the “110” stands for the angle of the curved region 101. The length of the portion of the guide device 14 that enters the body may range preferably from 3 inches to 5 inches, and the length of the portion that remains outside of the body is preferably at least 0.5 inches. The overall length of guide device 14 measured from the distal end of hub 108 to the distal tip of guide device 14 measured along a curved distal region of elongate shaft 102 is 4.25+/−0.25 inches. The length of guide device measured from the proximal end of hub 108 to the distal tip of guide device 14 measured along a curved distal region of elongate shaft 102 is 5.16+/−0.15 inches. The inner surface of guide device 14 may be lined by a lubricious coating or a tubular lubricious liner (not shown). Such a lubricious coating or tubular lubricious liner is useful to facilitate passage of one or more devices through the lumen of guide device 14 especially when guide device 14 comprises an angled, curved or bent region. Proximal portion of guide device 14 may comprise a rotating valve device (not shown) such as a Touhy-Borst device to lock down a device such as a sheath, guidewire, balloon catheter or other devices that are being inserted through guide device 14. The distal region of guide device 14 disclosed has a radiopaque marker 120 (see FIGS. 5E and 5F). The radiopaque marker may be made of suitable biocompatible materials including, but not limited to, metals, polymers loaded with a radiopaque substance, etc. In one embodiment, multiple guide devices 14 of varying designs are provided in a kit.
FIG. 5B shows a longitudinal sectional view of the guide device 14. The outer diameter of elongate shaft 102 is around 0.113+/−0.001 inches and the inner diameter of elongate shaft 102 is around 0.095+/−0.001 inches prior to being fused/laminated to the underlying tubing. In a preferred embodiment, the material of elongate shaft 102 has Rockwell hardness in the range of about 70R to about 110R. In this preferred embodiment, the distal portion of elongate shaft 102 is flexible enough to prevent or reduce damage to the anatomy. Yet, the distal portion is rigid enough to retain its shape as one or more devices are passed through guide device 14. Furthermore, the distal portion of elongate shaft 102 is rigid enough to enable a user to use the distal portion to displace paranasal structures. The distal portion of elongate shaft 102 comprises a curved or angled region 101 curved at an angle ranging from 0 degrees to 135 degrees. In a preferred embodiment, the inner surface of elongate shaft 102 is lined by a lubricious coating or a tubular lubricious liner 112 made of a suitable biocompatible material such as PTFE. In one embodiment, the inner diameter of lubricious liner 112 in guide device 14 is 0.087+/−0.003 inches. In one embodiment, lubricious liner 111 is made from a PTFE tube of outer diameter 0.093+0.0/−0.001 inches and an inner diameter of 0.089+/−0.001 inches which shrinks to about 0.087+/−0.003 inches upon bonding to inner surface of the elongate shaft 102. A radiopaque marker 120 (shown in FIG. 1F) is located in the distal region of elongate shaft 102 between plastic tube 112 and lubricious liner 112. The liner 111 extends beyond the distal end of plastic tube 112 and underlying marker 120 and the atraumatic tip member 104 is disposed about and secured to the distal end of the liner 111, as seen in the enlarged view of FIG. 5E. The atraumatic tip 104 may be formed of suitable biocompatible materials including, but not limited to a polyether block amide (Pebax 40D). Atraumatic tip 104 prevents or reduces accidental damage to the anatomy caused by the distal tip of guide device 14. In one embodiment, length of atraumatic tip 104 ranges from 0.060 to 0.120 inches. The material of atraumatic tip 104 can have a Shore Durometer hardness in the range of about 35D to about 72D. Guide device 14 further comprises a hypotube 114 to which elongate shaft 102 and outer cover 106 are attached. In a preferred embodiment, the outer diameter of hypotube 114 is 0.120+/−0.001 inches and the inner diameter is 0.112+/−0.002 inches. In a preferred embodiment of guide device 14, no portion of hypotube 114 is exposed to bodily fluids. In one embodiment of a method of constructing guide device 14, a stainless steel hypotube 114 is bonded to an elongate shaft 102 such as a Nylon tube to increase the strength of elongate shaft 102. In one embodiment of bonding hypotube 114 to elongate shaft 102, hypotube 114 is heat bonded to elongate shaft 102. One or more openings, perforations or holes may be located on hypotube 114 to enable material of elongate shaft 102 to melt into the one or more openings, perforations or holes. When the melted material of elongate shaft 102 solidifies, an additional mechanical bonding is created between hypotube 114 and elongate shaft 102. In another embodiment of bonding hypotube 114 to elongate shaft 102, hypotube 114 is bonded to elongate shaft 102 by an adhesive. The proximal end of guide device 14 comprises hub 108. In the embodiment shown, hub 108 is a female luer hub. In a preferred embodiment, the luer taper on such a female luer hub conforms to ISO 59471-1986 and ISO 59472-1991. Hub 108 may be attached to the outer surface of outer sleeve 106. In one embodiment, hub 108 is attached to the outer surface of outer sleeve 106 by a suitable biocompatible adhesive e.g. Dymax 1191. Hub 108 has two wings to enable a user to turn guide device 14. In a preferred embodiment, the two wings are located in the same plane as the plane of a curve on the distal region of elongate shaft 102 to assist the user in knowing where the tip of guide device 14 is pointing. In another embodiment, one wing can be longer than the other or have another indicia of which side of the device the curved tip of located. The guide device design shown in FIGS. 1A-1C is especially suited for trans-nasal access of the maxillary sinuses.
In a preferred embodiment, the length of atraumatic tip 104 ranges from 0.060 to 0.120 inches. The outer and/or inner rim of the distal end of atraumatic tip 104 may be radiused to reduce or eliminate sharp edges which in turn reduces or minimizes injury to tissue during the use of guide device 14. In one embodiment, the radius of curvature of the radiused outer and/or inner rim ranges from 0.005 to 0.012 inches. In a preferred embodiment, the tubular element is made of Pebax 40D and has an outer diameter ranging from 0.115+/−0.001 inches and an inner diameter ranging from 0.095+/−0.001 inches. Atraumatic tip 104 is fused to shaft 102 to form a butt joint. The tubular element is preferably designed using a suitable material of construction and a suitable manufacturing process such that there is negligible color bleeding from atraumatic tip 104. The distal end of guide device 14 also comprises a radiopaque marker 120. In the embodiment shown, radiopaque marker 120 is located between the distalmost region of elongate shaft 102 and lubricious liner 112. In one embodiment of guide device 14, no portion of radiopaque marker 120 is exposed to bodily fluids. Radiopaque marker 120 may be made of suitable biocompatible materials including, but not limited to, metals, polymers loaded with a radiopaque substance, etc. In one embodiment, radiopaque marker 120 comprises a platinum marker band of a length of 0.040+/−0.003 inches. The platinum marker band has an outer diameter of 0.096+/−0.001 inches and an inner diameter of 0.092+/−0.0005 inches. In the embodiment shown, the outer diameter of the flared distal end of elongate shaft 102 is 0.113+/−0.003 inches and the length of radiopaque marker is 0.04 inches. The length of atraumatic tip 104 ranges from 0.060 to 0.120 inches. The outer rim of atraumatic tip 104 is radiused. The distal end of outer sleeve 106 is tapered as shown and covers part of the protruding distal portion 101 of plastic tube 112. In a preferred embodiment shown, the outer diameter of the distal end of outer sleeve 106 is 0.109+/−0.003 inches.
The distal end of atraumatic tip 104 is designed to be as close to the distal end of radiopaque marker 120 as possible to minimize the length of atraumatic tip 104. In one embodiment of a method of manufacturing guide device 14, a PTFE tube that forms lubricious liner 112 is slid inside elongate shaft 102 made of Nylon. The distal end of elongate shaft 102 is flared to create an annular space between the flared distal end of elongate shaft 102 and lubricious liner 112. Thereafter, a platinum marker band that forms radiopaque marker 120 is slid over the PTFE tube into the annular space between the distal end of elongate shaft 102 and lubricious liner 112. Radiopaque marker 120 is attached to elongate shaft 102 and lubricious liner 112 by a suitable adhesive. Examples of such adhesives include, but are not limited to LoctiteTM 4011, etc. A Pebax tube that forms atraumatic tip 104 is slide over lubricious liner 112 such that the Pebax tube abuts against the distal end of elongate shaft 102. A suitable heat shrink tubing is inserted over guide device 14. The distal end of guide device 14 is heated. This fuses the Pebax tube to elongate shaft 102 and also fuses the Pebax tube to lubricious liner 112. Thereafter, the distal end of the Pebax tube may be trimmed. One advantage of this embodiment of a method of manufacturing guide device 14 is a strong bond between elongate shaft 102 made of Nylon and the Pebax tube that forms atraumatic tip 104. Another advantage of this embodiment of a method of manufacturing guide device 14 is that the distal most region of the Pebax tube that forms atraumatic tip 104 may be trimmed as close to the distal end of the platinum marker band to minimize the length of atraumatic tip 104. Such embodiments comprising a short atraumatic tip 104 enable easier navigation and/or torquing and/or repositioning of the distal tip of guide device within the paranasal anatomy with less injury to the patient.
FIG. 5C shows an enlarged view of the proximal portion of the guide device 14 and FIG. 5G shows a cross section through the shaft 102. As shown, in this example the shaft 102 of the guide device 14 comprises an inner liner 111 surrounded by plastic tube 112 which in turn is surrounded by hypotube 114 which in turn is surrounded by outer sleeve 106. In the embodiment shown, hub 108 is attached to the outer surface of outer sleeve 106 by a suitable biocompatible adhesive e.g. Dymax 1191. Hub 108 comprises a hub lumen 118 that is in fluid communication with the lumen enclosed by lubricious liner 112. Hub 118 may be designed such that the transition between hub lumen 118 and the lumen enclosed by lubricious liner 112 is smooth. This allows a seamless transition from hub lumen 118 to the lumen enclosed by lubricious liner 112.
FIG. 5D shows a sectional view of the guide device through the tapered transition portion of the shaft 102 at the distal end of hypotube 114. As shownm, in this example, the distal end of hypotube 114 terminates proximal to the distal end of plastic tube 112 and outer sleeve 106 covers the distal end of the hypotube 114 and tapers to a reduced outer diameter at its distal end, thereby providing a smooth outer surface over the distal end of hypotube 114. In this example, the length of the tapered region of outer cover 106 is 0.20 inches maximum. Thus, in this manner, outer cover 106 creates a smooth transition between the distal end of hypotube 114 and the protruding distal portion 101 of plastic tube 112.
Method and Device for Manufacture of the Guide Catheter
In one embodiment of a method of introducing a curve in elongate shaft 102 of guide device 14, the guide device is gradually bent while a polymeric region of the guide device is heated to a temperature greater than the temperature at which the polymeric region softens. For example, FIGS. 2A and 2B show the steps of a method of introducing an angle or curve in a guide device. FIG. 2A shows a partial sectional view through a bending device 122 comprising a shaping component 124 and a gripping component 126. Shaping component 124 comprises a curved region that defines the final radius of the angled or curved region of guide device 14. In one embodiment, bending device 122 is designed to detachably attach one of multiple shaping components 124 wherein each shaping component 124 has a unique shape. A suitable sized beading 128 is introduced through the lumen of guide device 14 as shown in FIG. 2A. Beading 128 is sized such that the outer diameter of beading 128 is slightly smaller than the diameter of the lumen of guide device 14. In a preferred embodiment, beading 128 is made of PTFE. Thereafter, a heat shrinkable tubing 130 is introduced over guide device 14 and beading 128. Heat shrinkable tubing 130 may be made of suitable polymers including, but not limited to Fluorinated Ethylene-Propylene (FEP), PTFE, PFA, ETFE, MFA, THV, etc. Thereafter, a region of the combination of guide device 14, beading 128 and heat shrinkable tubing 130 is fixed to bending device 122. In the embodiment shown in FIG. 2A, a region of the combination of guide device 14, beading 128 and heat shrinkable tubing 130 is fixed to bending device 122 by a spring grip 132 attached to gripping component 126. A region of guide device 14 to be bent is heated. This region of guide device 14 may be heated by convection or radiation. In one method embodiment, the region of guide device 14 to be bent is heated by blowing hot air on the region of guide device 14 to be bent. The hot air may be generated by a hot box. The temperature of the hot air ranges from 320 to 360 degrees F. In another method embodiment, the region of guide device 14 to be bent is heated by radiant heat generated from an electrical heater. Thereafter, the region of guide device 14 to be bent is bent as shown in FIG. 2B by applying a suitable mechanical bending force. In this embodiment, the region of guide device 14 to be bent was bent after heating the region of guide device 14 to be bent. In an alternate embodiment, the region of guide device 14 to be bent was heated while bending the region of guide device 14 to be bent. After bending the region of guide device 14 to be bent, guide device 14 is cooled. Guide device 14 is removed from bending device 122. Heat shrinkable tubing 130 and beading 128 are removed from guide device 14.
Various design parameters of the guide devices disclosed herein may be defined for quality control of the guide devices. Such parameters may include size parameters, shape parameters, tensile force parameters, etc. In one example, guide device 14 is designed to have a bond of tensile strength of 15 N between hub 108 and outer sleeve 106. In another example guide device 14 is designed to have a bond of tensile strength of 15 N between atraumatic tip 104 and elongate sheath 102. In another example, guide device 14 is designed to withstand a torque of 0.048 N-mapplied by torquing hub 108 relative to the straight region of guide device 14 distal to label tubing 110. The applied torque of 0.048 N-m should not cause kinking or failure of the bond between outer sleeve 106 and hypotube 114 or the bond between hub 108 and outer sleeve 106.
Guide device 14 may be used for introducing one or more devices into the anatomy. Examples of such devices include, but are not limited to, over-the-wire balloon catheters, fixed wire balloon catheters, rapid-exchange balloon catheters, guidewires, etc. Guide device 14 may also be used for applying suction to or providing lavage to an anatomical region.
It is to be appreciated that the non-removable guide member 22 need not necessarily extend through or into the catheter shaft 16 and the catheter shaft 16 need not necessarily be formed of flexible plastic. For example, FIGS. 8-9A show balloon catheter devices 12d, 12e having a curved tubular metal shaft 16d (FIGS. 8-8A) or a straight tubular metal shaft 16e (FIGS. 9-9A) with a balloon 18 mounted thereon. On opening 202 is formed in the wall of the tubular shaft 16d, 16e to permit inflation fluid to be infused into or extracted from the balloon 18. A non-removable guide member 200 attached to and extendds from the distal end DE of the metal shaft 16d, 16e. In this example, the non-removable guide member 200 does not extend substantially into or through the shaft 16d, 16e as in the embodiments described above. Rather, in this embodiment, the non-removable guide member 200 is attached to and extends distally from the distal end DE of the shaft 16d, 16e, as shown. This non-removable guide member 200 may be attached to the shaft 16d, 16e by soldering, welding, adhesive, threaded connection, crimping of the shaft, frictional engagement, or any other suitable connection technique. Examples of catheters having this type of construction (but lacking the non-removable guide member 22a) include those described in United States Patent Application Publication No. 2004/0064150A1, issued as U.S. Pat. No. 8,317,816 (Becker), the entire disclosure of which is expressly incorporated herein by reference.
Method for Dilating the Ostium of a Maxillary Sinus
FIGS. 7A-7E show steps in one example of a method for using the system 10 of FIG. 1 to dilate the ostium O of a maxillary sinus MS in a human subject. Anatomical structures in FIGS. 7A-7E are labeled as follows:
A number of the drawings in this patent application show anatomical structures of the ear, nose and throat. In general, these anatomical structures are labeled with the following reference letters:
















Nasal Cavity
NC



Frontal Sinus
FS



Frontal Sinus Ostium
FSO



Ethmoid Sinus
ES



Sphenoid Sinus
SS



Medial Turbinate
MT



Maxillary Sinus
MS



Uncinate Process
UP










Initially, as shown in FIG. 7A, the guide catheter 14 is inserted trans-nasally, advanced through the nasal cavity NC and positioned such that its distal end is adjacent to the ostium O of the maxillary sinus MS.
Thereafter, as shown in FIG. 7B, the balloon catheter 12 is inserted through the guide catheter 14 causing the distal portion of the non-removable guide member 22 to pass through the ostium and into the cavity of the maxillary sinus MS.
Then, as seen in FIG. 7C, the balloon catheter 14 is further advanced until the entire portion of the non-removable guide member 22 that protrudes beyond the distal end of the catheter shaft 16 is curled within the maxillary sinus MS and the balloon 18 has exited the distal end of the guide catheter 14 and is positioned within the ostium O. The positioning of the balloon within the ostium O may be verified by direct visualization, endoscopically and/or radiographically, as described elsewhere in this patent application.
Thereafter, as shown in FIG. 7D, the balloon 18 is inflated one or more times causing the ostium O to dilate.
Finally, as shown in FIG. 7E, the balloon is deflated and the balloon catheter 12 and guide catheter 14 are removed. In some cases, the guide catheter 14 may be allowed to remain in place after removal of the balloon catheter 12 and a lavage fluid, other substance or one or more other devices (e.g., lavage catheters, balloon catheters, cutting balloons, cutters, chompers, rotating cutters, rotating drills, rotating blades, sequential dilators, tapered dilators, punches, dissectors, burs, non-inflating mechanically expandable members, high frequency mechanical vibrators, dilating stents and radiofrequency ablation devices, microwave ablation devices, laser devices, snares, biopsy tools, scopes and devices that deliver diagnostic or therapeutic agents) may be passed through the guide catheter for further treatment of the condition.
Although the methods and devices disclosed herein are illustrated in conjunction with particular paranasal sinuses, it is understood that these methods and devices can be used in other paranasal sinuses as well as other anatomical passageways of the ear, nose or throat, such as Eustachian tube, larynx, and choana.
Optionally, any of the working devices and guide catheters described herein may be configured or equipped to receive or be advanced over a guidewire or other guide member (e.g., an elongate probe, strand of suture material, other elongate member) unless to do so would render the device inoperable for its intended purpose. Some of the specific examples described herein include guidewires, but it is to be appreciated that the use of guidewires and the incorporation of guidewire lumens is not limited to only the specific examples in which guidewires or guidewire lumens are shown. The guidewires used in this invention may be constructed and coated as is common in the art of cardiology. This may include the use of coils, tapered or non-tapered core wires, radiopaque tips and/or entire lengths, shaping ribbons, variations of stiffness, PTFE, silicone, hydrophilic coatings, polymer coatings, etc. For the scope of this invention, these wires may possess dimensions of length between 5 and 75 cm and outer diameter between 0.005′′ and 0.050′′.
Several modalities can be used with the devices and methods disclosed herein for navigation and imaging of the devices within the anatomy. For example, the devices disclosed herein may comprise an endoscope for visualization of the target anatomy. The devices may also comprise ultrasound imaging modalities to image the anatomical passageways and other anatomical structures. The devices disclosed herein may comprise one or more magnetic elements especially on the distal end of the devices. Such magnetic elements may be used to navigate through the anatomy by using external magnetic fields. Such navigation may be controlled digitally using a computer interface. The devices disclosed herein may also comprise one or more markers (e.g. infra-red markers). The markers can be used to track the precise position and orientation of the devices using image guidance techniques. Several other imaging or navigating modalities including but not limited to fluoroscopic, radiofrequency localization, electromagnetic, magnetic and other radiative energy based modalities may also be used with the methods and devices disclosed herein. These imaging and navigation technologies may also be referenced by computer directly or indirectly to pre-existing or simultaneously created 3-D or 2-D data sets which help the doctor place the devices within the appropriate region of the anatomy.
It is to be appreciated that the invention has been described herein with reference to certain examples or embodiments of the invention but that various additions, deletions, alterations and modifications may be made to those examples and embodiments without departing from the intended spirit and scope of the invention. For example, any element or attribute of one embodiment or example may be incorporated into or used with another embodiment or example, unless to do so would render the embodiment or example unsuitable for its intended use. Also, where the steps of a method or process are described, listed or claimed in a particular order, such steps may be performed in any other order unless to do so would render the embodiment or example un-novel, obvious to a person of ordinary skill in the relevant art or unsuitable for its intended use. All reasonable additions, deletions, modifications and alterations are to be considered equivalents of the described examples and embodiments and are to be included within the scope of the following claims.

## Claims

1. A balloon catheter device for dilating an opening of a paranasal sinus in a human or animal subject, said balloon catheter device comprising:
a catheter shaft having a proximal end and a distal end; and
a non-compliant or semi-compliant balloon mounted on the catheter shaft, said balloon being positionable within the opening of the paranasal sinus while in a non-inflated state and thereafter inflatable to an inflated state such that it will cause dilation of the opening of the paranasal sinus;
at least one position indicating element useable to determine when the balloon is positioned within the opening of the paranasal sinus; and
non-removable guide member, at least a portion of which extends from the distal end of the catheter shaft, said non-removable guide member having a limited range of axial movement or no movement relative to the catheter shaft, said non-removable guide member being advanceable through the opening of the paranasal sinus ahead of the catheter shaft, at least a distal portion of said non-removable guide member being more flexible in one plane than another;
wherein the balloon catheter device has a length less than about 20 cm.

2. A catheter device according to claim 1 wherein the non-removable guide member has at least two regions of differing stiffness.

3. A catheter device according to claim 1 wherein a proximal portion of the non-removable guide member resides within the catheter shaft and a distal portion of the guide member extends beyond the distal end of the catheter shaft.

4. A catheter device according to claim 3 wherein the proximal portion of the non-removable guide member extends through the entire length of the catheter shaft.

5. A catheter device according to claim 4 further comprising a hub on the proximal end of the catheter shaft, wherein the proximal portion of the non-removable guide member extends into and is anchored within said hub.

6. A catheter device according to claim 5 wherein the hub comprises a port that is in communication with the balloon to facilitate passage of inflation fluid into and out of the balloon.

7. A catheter device according to claim 6 wherein the hub comprises a fluid infusion port and wherein the crimpable element is crimped in a manner that allows fluid to flow past the location of the crimp.

8. A catheter device according to claim 5 wherein a portion of the hub includes a crimpable element which is crimped so as to engage and hold the proximal portion of the non-removable guide member within the hub.

9. A catheter device according to claim 1 wherein the at least one position indicating element comprises at least one marker on the catheter shaft, said marker being directly or endoscopically visible to the operator when the balloon is positioned within the opening of the paranasal sinus.

10. A catheter device according to claim 1 wherein the at least one position indicating element comprises at least one radiographically visible marker disposed on the non-removable guide member.

11. A catheter device according to claim 10 wherein the non-removable guide member extends through the region of the catheter shaft where the balloon is mounted and wherein radiographic markers are provided on the non-removable guide member to mark the location of the balloon.

12. A catheter device according to claim 11 wherein the balloon has a working length and the non-removable guide member comprises first and second radiographic markers, one of which is at one end of the balloon's working length and the other of which is at the other end of the balloon's working length.

13. A catheter device according to claim 1 wherein the at least one radiographically visible marker comprises a first marker marking the distal end of a working length of the balloon and a second marker marking the proximal end of the working length of the balloon.

14. A catheter device according to claim 1 wherein the balloon is substantially formed of a material selected from the group consisting of: polyethylene terephthalateterephthalate, nylon and polyamide.

15. A catheter device according to claim 1 wherein the balloon is capable of withstanding pressures of more than 22 atmospheres without bursting.

16. A catheter device according to claim 1 or 15 wherein the balloon is capable of breaking bone located around the opening of the paranasal sinus.

17. A catheter device according to claim 16 wherein the balloon is coated with a polymer coating.

18. A catheter device according to claim 16 wherein the coating is dip applied.

19. A catheter device according to claim 1 wherein the balloon is formed substantially of polyethylene terephthalate that is about 0.002 inch thick having a polyurethane coating disposed thereon, said coating being about 0.002 inch thick.

20. A catheter according to claim 1 wherein the balloon is formed substantially of polyethylene terephthalate that is about 0.002 inch thick having a polyurethane coating disposed thereon, said coating being about 0.002 inch thick.

21. A catheter according to claim 1 having a length of less than about 15 cm.

22. A catheter according to claim 1 having a length of less than about 10 cm.

23. A catheter device according to claim 1 wherein the non-removable guide member is formed substantially of a material selected from the group consisting of nickel-titanium alloy and stainless steel.

24. A catheter device according to claim 1 wherein a region of the non-removable guide member adjacent to its distal end comprises a segment of flattened core wire surrounded by a helical wire coil.

25. A catheter device according to claim 24 wherein the segment of flattened core wire has a height of from about 0.001 inch to about 0.004 inch.

26. A catheter device according to claim 1 wherein the non-removable guide member comprises a wire core having a proximal portion, a middle portion and a distal portion, said proximal portion being of substantially uniform diameter, said middle portion that is smaller in diameter at its distal end than at its proximal end and a distal portion of substantially uniform diameter.

27. A catheter device according to claim 26 wherein the proximal portion of the core wire has a diameter of 0.025 +/−0.0005 inch.

28. A catheter device according to claim 26 wherein the distal portion of the core wire is flattened.

29. A catheter device according to claim 26 or 28 wherein a helical wire coil surrounds the distal portion and at least some of the middle portion of the core wire.

30. A catheter device according to claim 29 wherein the helical wire coil has an outer diameter of from about 0.014 inch to about 0.038 inch.

31. A catheter device according to claim 28 wherein the flattened distal portion of the core wire has a flattened thickness of 0.001 to 0.006 inches.

32. A catheter device according to claim 1 wherein the non-removable guide member has a substantially radiolucent proximal region, a radiopaque middle region and a substantially radiolucent distal region.

33. A catheter device according to claim 32 wherein said at least one position indicating element comprises the radiopaque middle region of the non-removable guide member.

34. A catheter device according to claim 33 wherein the balloon has a working length and the position of the radiopaque middle region is coterminus with the working length of the balloon.

35. A catheter device according to claim 1 wherein at least a portion of the non-removable guide member extending beyond the distal end of the catheter shaft may be trimmed.

36. A catheter device according to claim 1 wherein the non-removable guide member is secured to the catheter device by adhesive.

37. A catheter device according to claim 1 wherein an outer polymer covering is disposed on at least a portion of the catheter device.

38. A catheter device according to claim 37 wherein the outer covering comprises heat-shrinkable material.

39. A catheter device according to claim 38 wherein the heat shrinkable material comprises polyether block amide.

40. A catheter device according to claim 1 wherein the balloon has a working length of about 12 to about 24 mm.

41. A system comprising a balloon catheter device according to claim 1 in combination with a guide catheter having a lumen through which the balloon catheter device is insertable.

42. A system according to claim 41 wherein the guide catheter has a substantially non-removable shape.

43. A system according to claim 42 wherein the guide catheter has a curve of between 0 degrees to about 135 degrees.

44. A system according to claim 42 further comprising a tubular outer cover having a distal end.

45. A system according to claim 44 wherein the outer cover extends beyond the distal end of the metal tube but terminates short of the distal end of the plastic tube.

46. A system according to claim 45 wherein the outer cover has a distal end that is tapered so as to provide a smooth transition from the outer surface of the plastic tube.

47. A system according to claim 42 or 44 further comprising an inner liner lining the lumen of the plastic tube.

48. A system according to claim 47 wherein a radiopaque marker is captured between the inner liner and the plastic tube.

49. A system according to claim 48 wherein the distal end of the plastic tube stops short of the distal end of the inner liner such that a distal portion of the inner liner protrudes beyond the distal end of the plastic tube, and wherein an atraumatic tip member formed of material that is softer than the plastic tube is disposed about the distal portion of the inner liner.

50. A system according to claim 41 wherein the guide catheter comprises a metal tube having a lumen and a distal end and a plastic tube having a lumen and a distal end, said plastic tube extending coaxially through the lumen of the metal tube with a distal portion of the plastic tube extending out of and beyond the distal end of the metal tube.

51. A system according to claim 50 wherein the distal portion of the plastic tube is curved.

52. A catheter device according to claim 1 wherein the distal portion of the non-removable guide member that extends beyond the end of the catheter shaft is an atraumatic tip.

53. A catheter device according to claim 1 wherein at least a portion of the non-removable guide member is coated.

54. A catheter device according to claim 1 wherein the balloon is coated with a polymer coating and at least a portion of the non-removable guide member is coated with a different coating.

55. A catheter device according to claim 1 wherein the catheter shaft is flexible.

56. A catheter device according to claim 1 wherein the catheter shaft is formed of plastic.

57. A catheter device according to claim 1 wherein the catheter shaft is formed of metal.

58. A catheter device according to claim 57 wherein the catheter shaft is formed of metal hypotube.

59. A catheter device according to claim 57 wherein the catheter shaft is formed of straight metal tube.

60. A catheter device according to claim 57 wherein the catheter shaft is formed of curved metal tube.