Patent Document

CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims the benefit of Provisional U.S. Patent Application Ser. No. 61/877,473, filed on Sep. 13, 2013, pending, which application is incorporated by reference herein in its entirety. 
     
    
     TECHNICAL FIELD 
       [0002]    The present invention relates, in general, to medical devices, and, in particular, to medical devices and related methods for the treatment of sinus conditions. 
       BACKGROUND 
       [0003]    Balloon dilatation devices have been used to treat constricted paranasal sinus passageways for several years. These balloon dilatation devices generally involve the use of an inflatable balloon located at the distal end of a catheter such as a balloon catheter. The balloon catheter may include a substantially rigid inner guide member and a movable shaft coupled to a balloon that is slidably mounted on the rigid inner guide member. The inner guide member might be a stainless steel wire or flexible plastic member to facilitate the location and access of sinus ostia, and is generally introduced through the nostril into the target sinus under endoscopic visualization. A flexible wire or flexible plastic member is introduced through the inner guide member and gently advanced into the target sinus. The balloon catheter generally slides over the inner guide member and the flexible wire, and it is positioned across the constricted ostium. The balloon is gradually inflated, generally with a liquid medium, to gently restructure the constricted ostium. The balloon is then deflated and removed, and an irrigation system may be advanced to wash the sinus with a sterile solution. Generally, this procedure is referred to as Balloon Sinuplasty™, and a number of U.S. patents and patent applications including U.S. Pat. Nos. 7,645,272, 7,654,997, and 7,803,150 describe various embodiments of the medical procedure and devices used in the performance of such procedure. 
         [0004]    Such conventional methods and apparatus, however, have significant drawbacks. Generally, these methods do not provide a way to advance the inner guide member and balloon catheter easily and effectively, especially in patients with constricted nostrils or deviated septums or constricted openings to the middle meatus. Additionally, traditional balloon catheters distribute the force equally on the surrounding structures during the dilatation process. In some cases, the balloon catheter is located near critical structures that can be easily damaged by the omnidirectional force applied by traditional balloon catheters. Therefore, there has been a long-desired but unresolved need for a system or method that could direct the force applied by a balloon catheter during the dilatation process for protecting delicate structures and also for aiding in the process of accessing the target paranasal sinus. 
       SUMMARY 
       [0005]    According to a first embodiment, a force-directional nasal surgery dilatation device for use in a nasal surgery is provided, the device comprising: 
         [0006]    an inflatable balloon; 
         [0007]    a shaft for supporting the balloon at a distal end and guiding the balloon into position for a procedure involving a patient; 
         [0008]    an inflation passageway associated with the shaft for introducing an inflation medium into the balloon; and 
         [0009]    a force directional member adjacent a side of the balloon; 
         [0010]    wherein, when the balloon is inflated in a nasal passage or sinus ostia of the patient, the amount of force applied to tissue adjacent the force directional member is less than the amount of force applied to other tissue in the nasal passage or sinus ostia of the patient. 
         [0011]    According to a second embodiment, a method for the dilatation of a nasal passage or sinus ostia of a patient is provided, the method comprising: 
         [0012]    advancing the distal end of a device as set forth above into a nasal passage or sinus ostia of the patient such that the balloon is positioned in an area to be treated; 
         [0013]    inflating the balloon within the nasal passage or sinus ostia to apply pressure to tissue adjacent the balloon; 
         [0014]    deflating the balloon; 
         [0015]    removing the device from the patient. 
         [0016]    According to a third embodiment, a force-directional nasal surgery dilatation device for use in a nasal surgery is provided, the device comprising: 
         [0017]    a shaft having a distal end and a proximal end, a distal axis adjacent the distal end and a proximal axis adjacent the proximal end, the shaft having an opening from the distal end to the proximal end to allow the passage of a balloon dilatation catheter therethrough; and 
         [0018]    a force directional member connected to the distal end of the shaft; 
         [0019]    wherein the force directional member comprises: a proximal portion connected to the distal end of the shaft and projecting radially outward from the distal axis of the shaft and a central portion connected to the distal end of the proximal portion and extending along the distal axis of the shaft. 
         [0020]    According to a fourth embodiment, a method for dilatation of a nasal passage or sinus ostia of a patient is provided, the method comprising: 
         [0021]    advancing the distal end of the device of claim  16  into a nasal passage or sinus ostia of the patient such that the force directional member is positioned in an area to be treated; 
         [0022]    advancing a balloon dilatation catheter comprising an inflatable balloon through the opening in the shaft until the balloon is adjacent the force directional member; 
         [0023]    inflating the balloon within the nasal passage or sinus ostia to apply pressure to tissue adjacent the balloon; 
         [0024]    deflating the balloon; 
         [0025]    removing the balloon dilatation catheter and the device from the patient. 
         [0026]    According to a fifth embodiment, a force-directional nasal surgery dilatation device for use in a nasal surgery is provided, the device comprising: 
         [0027]    a shaft having a distal end and a proximal end, a distal axis adjacent the distal end and a proximal axis adjacent the proximal end, the shaft having an opening from the distal end to the proximal end to allow the passage of a balloon dilatation catheter therethrough; 
         [0028]    an inflatable balloon, the inflatable balloon having a proximal end adjacent the distal end of the shaft and a distal end; 
         [0029]    a force application member having a proximal end adjacent the distal end of the balloon and a distal end, wherein the force directional member is capable of forward linear movement relative to the shaft along the distal axis upon inflation of the inflatable balloon. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0030]    The accompanying drawings illustrate one or more embodiments and/or aspects of the disclosure, and together with the written description, serve to explain the principles of the disclosure. Wherever possible, the same reference numbers are used throughout the drawings to refer to the same or like elements of an embodiment, and wherein: 
           [0031]      FIGS. 1A-1E  illustrate the use of a balloon dilatation device wherein:  FIG. 1A  shows the device with the balloon uninflated prior to insertion;  FIG. 1B  shows the device after insertion;  FIG. 1C  shows the inserted device with the balloon inflated;  FIG. 1D  shows the inserted device after the balloon has been deflated; and  FIG. 1E  shows the device after removal. 
           [0032]      FIG. 2A  illustrates a perspective view of the collapsed balloon dilatation catheter according to one embodiment. 
           [0033]      FIG. 2B  illustrates a front view of the collapsed balloon dilatation catheter of  FIG. 2A . 
           [0034]      FIG. 2C  illustrates a perspective view of the collapsed balloon of  FIG. 2A . 
           [0035]      FIG. 2D  illustrates a front view of the deflated balloon of  FIG. 2A . 
           [0036]      FIG. 2E  illustrates a perspective view of the inflated balloon dilatation catheter of  FIG. 2A . 
           [0037]      FIG. 2F  illustrates a perspective view of the inflated balloon of  FIG. 2A . 
           [0038]      FIG. 2G  illustrates a front view of the inflated balloon of  FIG. 2A . 
           [0039]      FIG. 3A  illustrates a perspective view of the collapsed balloon dilatation catheter according to one embodiment. 
           [0040]      FIG. 3B  illustrates a front view of the collapsed balloon dilatation catheter of  FIG. 3A . 
           [0041]      FIG. 3C  illustrates a perspective view of the collapsed balloon of  FIG. 3A . 
           [0042]      FIG. 3D  illustrates a front view of the deflated balloon of  FIG. 3A . 
           [0043]      FIG. 3E  illustrates a perspective view of the inflated balloon dilatation catheter of 
           [0044]      FIG. 3A . 
           [0045]      FIG. 3F  illustrates a perspective view of the inflated balloon of  FIG. 3A . 
           [0046]      FIG. 3G  illustrates a front view of the inflated balloon of  FIG. 3A . 
           [0047]      FIG. 4A  illustrates a perspective view of the balloon dilatation catheter according to one embodiment. 
           [0048]      FIG. 4B  illustrates a side view of the balloon dilatation catheter of  FIG. 4A . 
           [0049]      FIG. 4C  illustrates a top view of the balloon dilatation catheter of  FIG. 4A . 
           [0050]      FIG. 5A  is an axial cross-sectional view of a human skull through a region involving the nasal passages, illustrating the insertion of an exemplary collapsed balloon dilatation catheter for a deviated septum procedure. 
           [0051]      FIG. 5B  is an axial cross-sectional view of a human skull through a region involving the nasal passages, illustrating the placement of an exemplary collapsed balloon dilatation catheter into position prior to inflation for a deviated septum procedure. 
           [0052]      FIG. 5C  is an axial cross-sectional view of a human skull through a region involving the nasal passages, illustrating the inflation of an exemplary balloon dilatation catheter for a deviated septum procedure. 
           [0053]      FIG. 5D  is an axial cross-sectional view of a human skull through a region involving the nasal passages, illustrating the deflation of an exemplary balloon dilatation catheter and removal (or repositioning) of the device after a deviated septum procedure. 
           [0054]      FIG. 6A  is an axial cross-sectional view of a human skull through a region involving the nasal passages, illustrating the insertion of an exemplary collapsed balloon dilatation catheter for a procedure involving the middle turbinate. 
           [0055]      FIG. 6B  is an axial cross-sectional view of a human skull through a region involving the nasal passages, illustrating the placement of an exemplary collapsed balloon dilatation catheter for a procedure involving the middle turbinate. 
           [0056]      FIG. 6C  is an axial cross-sectional view of a human skull through a region involving the nasal passages, illustrating the inflation of an exemplary balloon dilatation catheter for a procedure involving the middle turbinate. 
           [0057]      FIG. 6D  is an axial cross-sectional view of a human skull through a region involving the nasal passages, illustrating the deflation of an exemplary balloon dilatation catheter and removal of the device (or repositioning) after a procedure involving the middle turbinate. 
           [0058]      FIG. 7  is a schematic of a balloon dilatation device comprising a wedge which is driven forward upon inflation of the balloon. 
           [0059]      FIG. 8  is a schematic of a balloon dilatation device comprising first and second wedge elements which are forced apart by the inflation of the balloon. 
       
    
    
     DETAILED DESCRIPTION 
       [0060]    For the purpose of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will, nevertheless, be understood that no limitation of the scope of the disclosure is thereby intended; any alterations and further modifications of the described or illustrated embodiments, and any further applications of the principles of the disclosure as illustrated therein are contemplated as would normally occur to one skilled in the art to which the disclosure relates. 
         [0061]    Referring now to the drawings, in which like numerals illustrate like elements throughout several drawing figures,  FIGS. 1A-1E  illustrate the use of a balloon dilatation device as described herein.  FIG. 1A  shows the device with the balloon uninflated prior to insertion. As shown in  FIG. 1B , the device is advanced into the nasal passage or sinus ostia of a patient with the balloon deflated. When the balloon is adjacent the area to be treated, the balloon is then inflated as shown in  FIG. 1C . The balloon is then deflated as shown in  FIG. 1D  and removed from the patient as disclosed in  FIG. 1E . 
         [0062]      FIG. 2A  illustrates a preferred embodiment of the apparatus of the present invention, being a balloon dilatation catheter, generally denoted as  100 , for the dilatation of a sinus ostium, mobilize the septum, or engage the middle meatus. The balloon dilatation catheter  100  generally comprises a balloon  124 , a shaft  118 , a shaft supporting member  115 , and a hub  112  with an inflation port  109  and a guide port  106 . The hub  112  is a generally trapezoidal supporting member that connects the inflation port  109 , wire port  106  and the proximal end of the shaft  118 . In one aspect, the guide port  106 , the shaft  118 , the shaft supporting member  115  and the balloon  124  extend concentrically along the same axially extending line. The balloon catheter  100  generally terminates at a distal tip  130  that projects distally and concentrically from the balloon. The balloon  124  is generally attached to the distal end of the shaft  118 , whereas the proximal end of the shaft  118  is attached to the hub  112 . 
         [0063]    In one aspect, the shaft supporting member  115  is an axially elongated annular structure, where one of the two faces that connect its inner and outer peripheral walls is attached to the hub  112 . The inner peripheral wall of the shaft supporting member  115  generally contacts a portion of the outer surface of the shaft as a means to provide stuffiness to the shaft  118 . In one aspect, the portion of the shaft  118  covered by the supporting member  115  is approximately a fifth of the total length of the shaft  118 . The inflation port  109  extends distally from the hub  112  in an angular direction with respect to the guide port  106  as a means of allowing the operator rotate or shift the balloon dilatation catheter  100  for positioning the distal segment of the force-directional catheter  100  into the target structure of the nasal cavity at various angles appropriate to each individual patient and procedure. In one aspect, the inflation port  109  extends distally from the hub forming a 45 degree angle with the guide port  106 . 
         [0064]    In one aspect, the balloon  124 , shaft  118 , shaft supporting member  115 , and hub are made of plastic and attached together using a fusing process, adhesive, insert molding or laser welding. Materials for the shaft  118  can include, but are not limited to: polyamide, PEBAX (polyether-block-amide), polyethylene, polyurethane, LCP (liquid crystal polymer), PVC (polyvinyl-chloride) and PET (polyether-terephthalate). In one aspect, internal supportive materials of the force-directional catheter  100  may comprise a variety of metals and pseudoelastic alloys, including; stainless steel ( 300  series), titanium and nickel-titanium alloys (NiTiNOL). Fusion of these dissimilar materials can be accomplished by using coatings or co-extrusions of compatible materials. Balloon  124  materials can include; polyamide, PEBAX, polyurethane and PET. Preferably, the balloon  124  materials incorporate attributes including non-compliance (balloons that inflate to a fixed diameter) or semi-compliance (balloons that inflate to a designated diameter, with limited capability to over expand under higher pressures) and durability (resistance to tearing or puncture when expanded against rigid and irregular surfaces). As will be understood and appreciated, the components of the sections of the balloon dilatation catheter  100  shown in  FIG. 2A  can be constructed of virtually any dimension or size, and a variety of materials and sizes are possible according to various embodiments of the present disclosure. Generally, however, the balloon  124  is preferable from about 14 mm to 16 mm in length. 
         [0065]    In one aspect, the balloon catheter is formed using an inner tube coaxially arranged within an outer tube. The inner tube defines the guide lumen for passage of the guide. Generally, the balloon catheter  100  slides along the guide, which is a rigid or semi-rigid member received through the guide port  106 , advanced through the balloon catheter  100  and that can project distally from the distal tip  130 . The annular space formed in between the inner and outer tubes defines the inflation lumen which extends from the inflation port  109 , through the shaft  118  and into the balloon  124 . In one aspect, the inflation lumen may hold a fluid which is used to inflate the balloon  124 . In another aspect, two tubes are contained inside of the shaft  118 , where one defines the lumen for passage of the guide, and the other defines the inflation lumen. In one aspect, the inflation port  109 , the guide port  106  and the shaft  118  are connected in the hub  112 . The inflation port  109  is a tube generally bounded to a Luer connector  103 , which receives the fluid to inflate the balloon. The Luer connector  103  can be adhesive bonded or insert molded onto the port tubing. The Luer connector  103  can also be made from compatible polymeric materials, including; polyamide, PEBAX, HDPE (high density polyethylene) or rigid PVC. Connector materials more likely to require adhesive bonding include polycarbonate and acrylic. Metal Luer connectors are also common, and that are mechanically locked to the port inflation  109 . The Luer connector  103  allows a fluid delivery system to lock into the inflation port  109  of the balloon catheter  100 . As will occur to one of ordinary skill in the art, the Luer connector  103  illustrated in  FIG. 2A  is generally a tube surrounding approximately half of the inflation port  109  and is terminated in an external thread  133 . Further, the Luer connector  103  may comprise two generally trapezoidal grips  121  along its outer peripheral surface facing in opposite directions to facilitate the manual attachment of the fluid delivery system. In one aspect, the fluid delivery system is a syringe containing an uncompressible fluid or a pressure-controlled balloon inflation device. 
         [0066]    Referring to  FIG. 2B  and  FIG. 2D , the collapsed or deflated balloon  124  is a generally folded, star-shaped polygon with three congruent arms that extend distally from the center of the polygon, and are generally positioned 120 degrees from one another. Generally, the folded balloon may have between two and five arms extending from the center, depending on the size of the balloon and the desired folded profile of the deflated balloon. In one aspect, the arms generally form three concentric curved surfaces around the axial line that extends longitudinally through the center of the balloon  124 , and a force distribution member  127  is positioned directly over one of the curved surfaces. As illustrated in  FIG. 2C , the force distribution member  127  is a generally rectangular flexible member attached to a side of the balloon  124  that adapts to the corresponding shape of the balloon  124 . In one aspect, the force distribution member  127  has generally rectangular openings  136  longitudinally distributed along its center to facilitate the bending of the force distribution member  127 . In one aspect illustrated in  FIG. 2C , the force distribution member  127  has a concentric opening  136   b  in between two smaller openings  163   a ,  136   b . The openings facilitate the bending of the force distribution member  127  without compromising its structural integrity. 
         [0067]    As illustrated in  FIG. 2E ,  FIG. 2F  and  FIG. 2G , the inflated balloon  124 ′ is generally comprised of a flattened planar surface extending axially along a generally cylindrical balloon, as though the cylinder were bisected by a plane passing through two axially extending parallel lines along the outer surface of the cylinder. Generally, the force distribution member  127 ′ is attached to the flattened planar surface of the inflated balloon  124 ′. The expanded or inflated diameter of the balloon  124 ′ depends on the initial and final desired size of the ostium or nostril to be treated. In one aspect, the balloon  124 ′ inflates to a fixed size and cannot be inflated beyond. In another aspect, the balloon  124 ′ inflates to a maximum size before there is structural damage to the balloon  124 ′, and the pressure applied to the balloon  124 ′ must be regulated with the fluid delivery system or balloon inflation device. 
         [0068]    Referring now to  FIG. 3A , another embodiment of the apparatus of the present invention is illustrated, being a balloon dilatation catheter for the dilatation of a nostril or a sinus ostium, generally denoted as  200 .  FIG. 3A  generally reassembles the embodiment illustrated in  FIG. 2A , with a similar balloon  209  and the addition of a force-directional member  206  and a shaft shielding member  203 . The guide port  106 , the shaft  118 , the shaft supporting member  115 , and the balloon  124  generally extend concentrically along the same axially extending line. In one aspect, the shaft shielding member  203  is a generally hollow, rigid, cylinder extending concentrically along the same axially extending line as the shaft  118  as though the cylinder were bisected by a plane passing through two axially extending parallel lines along the outer surface of the shaft  118  or two axially extending parallel lines in close proximity to the outer surface of the shaft  118 . 
         [0069]    In one aspect, the shaft shielding member  203  extends from the distal end of the shaft supporting member  115  to the distal end of the shaft  118 . Generally, the shaft shielding member  203  is attached to the shaft  118  as a means to provide sturdiness to the force-directional member  206 . In one embodiment, however, the shaft shielding member  203  and the shaft  118  are combined into a single member, where the single member attaches directly to the shaft supporting member  115 . The balloon force-directional member  206  is a generally marginally-curved plate resting in close proximity to the outer side of the balloon  209  and attached to the distal end of the shaft shielding member  115 . In one aspect, the balloon force-directional member  206  is comprised of two plates attached together and extending parallel to the balloon  209 . The first plate of the balloon force-directional member  206  is a generally trapezoidal plate with the parallel side of smaller dimensions attached to the distal end of the shaft shielding member. The second plate of the balloon force-directional member  206  is a generally rectangular plate with one side attached to the distal end of the first plate of the balloon force-directional member  206 . In one aspect, the two plates comprised by the balloon force-directional member  206  have approximately the same length, and the balloon force-directional member  206  has a length of approximately half the length of the balloon  209 . The balloon  209  is generally attached to the distal end of the shaft  118 , whereas the proximal end of the shaft  118  is attached to the hub  112 . 
         [0070]    In one aspect, the balloon  209 , a force-directional member  206 , shaft  118 , shaft supporting member  115 , shaft shielding member  203 , and hub  112  are made of plastic and attached together using a fusing process, adhesive, insert molding or laser welding. Balloon  209  materials can include; polyamide, PEBAX, polyurethane and PET. Preferably, the balloon  209  materials incorporate attributes including non-compliance (balloons that inflate to a fixed diameter) or semi-compliance (balloons that inflate to a designated diameter, with limited capability to over expand under higher pressures) and durability (resistance to tearing or puncture when expanded against rigid and irregular surfaces). Materials for the balloon dilatation catheter  200  include, but are not limited to: polyamide, PEBAX (polyether-block-amide), polyethylene, polyurethane, LCP (liquid crystal polymer), PVC (polyvinyl-chloride) and PET (polyether-terephthalate). Internal supportive materials of the balloon dilatation catheter  200  can incorporate a variety of metals and pseudoelastic alloys, including; stainless steel ( 300  series), titanium and nickel-titanium alloys (NiTiNOL). Generally, fusion of these dissimilar materials can be accomplished by using coatings or co-extrusions of compatible materials. As will be understood and appreciated, the components of the sections of the balloon dilatation catheter  200  shown in  FIG. 3A  can be constructed of virtually any dimension or size, and a variety of materials and sizes are possible according to various embodiments of the present disclosure. Generally, however, the collapsed balloon  124  is preferable from about 14 mm to 16 mm in length. 
         [0071]    Referring to  FIG. 3B ,  FIG. 3C  and  FIG. 3D , the collapsed or deflated balloon  209  is a folded generally star-shaped polygon with three congruent arms that extend distally from the center of the polygon, and are generally positioned 120 degrees from one another. The folded balloon may have between two and five arms extending from the center, depending on the size of the balloon and the desired folded profile of the deflated balloon  209 . The arms generally form three concentric curved surfaces around the axial line that extends longitudinally through the center of the balloon  124 . In one aspect, the balloon force-directional member  206  is positioned in close proximity to the balloon  209 , and the edges of the balloon force-directional member  206  abut at least one of the arms extending from the center of the balloon  209 . In one aspect illustrated in  FIG. 3B , FIG.  3 C and  FIG. 3D , the edges of the balloon force-directional member  206  abut two of the arms extending from the center of the balloon  209 . 
         [0072]    As illustrated in  FIG. 3E ,  FIG. 3F  and  FIG. 3G , the inflated balloon  209 ′ is comprised of a marginally-curved surface extending along a generally cylindrical balloon  209 ′, as though the cylinder were bisected by a plane passing through two axially extending parallel lines along the outer surface of the cylinder, and the flattened side obtained by the bisection were extended outwardly from the balloon  209 ′ to create a marginally-curved surface. Generally, the marginally-curved surface of the inflated balloon  209 ′ abuts the balloon force-directional member  206 , and the inflated balloon  209 ′ and the balloon force-directional member  206  possess the same curvature. In one aspect, the length of balloon force-directional member  206  is approximately the diameter of the inflated balloon  209 ′, and the balloon force-directional member  206  completely covers the marginally-curved surface of the inflated balloon  209 ′. The expanded or inflated diameter of the balloon  209 ′ depends on the initial and final desired size of the ostium or nostril to be treated. In one aspect, the balloon  209 ′ inflates to a fixed size and cannot be inflated beyond. In an alternate aspect, the balloon  209 ′ inflates to a maximum size before there is structural damage to the balloon  209 ′, and the pressure applied to the balloon  209 ′ must be regulated with the fluid delivery system or balloon inflation device. 
         [0073]      FIG. 4A ,  FIG. 4B  and  FIG. 4C  illustrate another embodiment of the apparatus of the present invention, generally denoted as  300 , being a force-directional device for a balloon dilatation catheter for the dilatation of a sinus ostium, mobilize the septum, or engage the middle meatus. The force-directional device  300  comprises a shaft  303 , a connecting system  309 , and a force-directional member  312 . Generally, the force-directional member  312  is connected to the shaft  303  via the connecting system  309 . In one aspect illustrated in  FIG. 4B , the force-directional device  300  can be mounted and dismounted from the shaft  303  by the connecting system  309  located at the proximal end of the force-directional member  312 . In one aspect, the connecting system  309  is a generally cylindrical member with two adjacent inner annular spaces, where one of the inner annular spaces has a smaller diameter. Generally, the inner annular space of smaller diameter is located furthest from the force-directional member  312 , so that the force-directional member  312  can be locked or mounted onto the shaft  303 . Generally, the shaft  303  has a cylindrical notch near the distal end of the shaft  303  in accordance with the dimensions of the connecting system  309  as a means to providing a location for the connecting system  309  to lock onto the shaft  303 . Generally, the force-directional member  312 , the connecting member  309  and the shaft  303  extend along the same axially extending line. In one aspect, the shaft  303  of the force-directional device  300  is bent or angled to provide easier manual operation while accessing the nasal cavity. The shaft  303  is angled at approximately the middle of the shaft  303 , but it can be angled at any point as will occur to one of ordinary skill in the art. The angled segment in the shaft  303  allows the operator of the device  300  to rotate or shift the shaft  300  as a means for positioning the distal segment of the force-directional device  300  into the target structure of the nasal cavity at various angles appropriate to each individual patient and procedure. 
         [0074]    The force-directional device  300  terminates at a distal aperture  315  located at the distal end of the force-directional device  300 . The force-directional member  312  is generally attached to the distal end of the shaft  303 , whereas the proximal end of the shaft  118  comprises an aperture or balloon port  318 . In one aspect, the shaft  303  in the force-directional device  300  is formed by a generally hollow cylinder, where the inner annular space in the shaft  303  defines the lumen for passage of an object, such as a balloon dilatation catheter. In one aspect, the balloon dilatation catheter is received through the balloon port  318 , advanced through the inner annular space formed in the shaft  118 , and through the distal opening of the shaft  306  until the tip of the balloon dilatation catheter abuts the force-directional member  312 . Generally, the distal tip of the balloon in a balloon dilatation catheter is received through the distal aperture  315  located at the distal end of the force-directional device  300  as a means to fixing the position of the balloon dilatation catheter with respect to the force-directional device  300 . 
         [0075]    In one aspect, the force-directional member  312 , shaft  303 , and connecting member  306  are made of plastic and attached together using a fusing process, adhesive, insert molding or laser welding. Materials for the force-directional device  300  include, but are not limited to: polyamide, PEBAX (polyether-block-amide), polyethylene, polyurethane, LCP (liquid crystal polymer), PVC (polyvinyl-chloride) and PET (polyether-terephthalate). Internal supportive materials can incorporate a variety of metals and pseudoelastic alloys, including; stainless steel ( 300  series), titanium and nickel-titanium alloys (NiTiNOL). Fusion of these dissimilar materials can be accomplished by using coatings or co-extrusions of compatible materials. Balloon materials can include; polyamide, PEBAX, polyurethane and PET. It is preferable that the balloon materials incorporate attributes including non-compliance (balloons that inflate to a fixed diameter) or semi-compliance (balloons that inflate to a designated diameter, with limited capability to over expand under higher pressures) and durability (resistance to tearing or puncture when expanded against rigid and irregular surfaces). 
         [0076]    Referring to  FIG. 4B  and  FIG. 4C , the force-directional member  312  is a generally flat plate with a curved distal end to position the distal aperture  315  in a location corresponding with the dimensions of a balloon dilatation catheter, so that after the balloon dilatation catheter has been advanced through the distal opening  306  in the shaft  303 , the tip of the balloon dilatation catheter is received through the distal aperture  315  in the force-directional member. Generally, the dimensions of the force-directional member  312  correspond to the dimensions of the inflated balloon of a balloon dilatation catheter. Therefore, when the balloon dilatation catheter has been advanced through the distal opening  306  in the shaft  303 , the tip of the balloon dilatation catheter has been received through the distal aperture  315  in the force-directional member, and the balloon in the balloon dilatation catheter has been inflated, the force-directional member constrains the expansion of the balloon beyond the contour of the force-directional member  312 . In one aspect, the force-directional member  312  is a generally rectangular member attached to a side of the balloon  124 , which adapts to the corresponding shape of the force-directional member  312 . 
         [0077]      FIGS. 5A-5D  and  6 A- 6 D illustrate use of a balloon dilatation catheter device  100  in connection with a nasal surgery. 
         [0078]      FIG. 5A  is an axial cross-sectional view of a human skull through a region involving the nasal passages, illustrating the insertion of an exemplary collapsed balloon dilatation catheter  100  for a deviated septum procedure. 
         [0079]      FIG. 5B  is an axial cross-sectional view of a human skull through a region involving the nasal passages, illustrating the placement of an exemplary collapsed balloon dilatation catheter  100  into position prior to inflation for a deviated septum procedure. 
         [0080]      FIG. 5C  is an axial cross-sectional view of a human skull through a region involving the nasal passages, illustrating the inflation of an exemplary balloon dilatation catheter  100  for a deviated septum procedure. 
         [0081]      FIG. 5D  is an axial cross-sectional view of a human skull through a region involving the nasal passages, illustrating the deflation of an exemplary balloon dilatation catheter  100  and removal (or repositioning) of the device after a deviated septum procedure. As will be appreciated, the balloon of the device may be deflated, and the device repositioned for subsequent inflation against a different surface, or repeatedly against the same surface, until the desired results are achieved, prior to deflating the balloon and removing the device. 
         [0082]      FIG. 6A  is an axial cross-sectional view of a human skull through a region involving the nasal passages, illustrating the insertion of an exemplary collapsed balloon dilatation catheter for a procedure involving the middle turbinate. 
         [0083]      FIG. 6B  is an axial cross-sectional view of a human skull through a region involving the nasal passages, illustrating the placement of an exemplary collapsed balloon dilatation catheter for a procedure involving the middle turbinate. 
         [0084]      FIG. 6C  is an axial cross-sectional view of a human skull through a region involving the nasal passages, illustrating the inflation of an exemplary balloon dilatation catheter for a procedure involving the middle turbinate. 
         [0085]      FIG. 6D  is an axial cross-sectional view of a human skull through a region involving the nasal passages, illustrating the deflation of an exemplary balloon dilatation catheter and removal of the device (or repositioning) after a procedure involving the middle turbinate. As will be appreciated, the balloon of the device may be deflated, and the device repositioned for subsequent inflation against a different surface, or repeatedly against the same surface, until the desired results are achieved, prior to deflating the balloon and removing the device. 
         [0086]    During a medical procedure to treat the nasal cavity illustrated in  FIGS. 5A-5D  and  6 A- 6 D, the operator (e.g. surgeon) generally holds an elongated, tubular, at least semi-rigid guide  406  in one hand using a handler or similar member. In some aspects, the guide is coupled to an endoscope for visual recognition of the nasal cavity  412 . Generally, a balloon dilatation catheter resides within the lumen of the guide  406 , and the distal end of the guide  406  is advanced through the nostril  415  to a position in proximity to the opening  415  of a paranasal sinus  400  (i.e. sinus ostium) with the aid of the endoscopic visualization. In some cases, the guide has a light source at the distal end for viewing the emitted light from the outside of the patient to confirm that the guide is located in the target position. Once the target position of the guide  406  has been reached and confirmed, the balloon dilatation catheter is generally advanced through the guide  406  to position the balloon dilatation catheter in the opening of a sinus ostium  415 . In one aspect, a flexible wire  403  is introduced through the inner guide  406  and gently advanced into the target sinus  418 . The balloon dilatation catheter generally slides through the inner guide  406  and over the flexible wire  403 , and it is positioned across the constricted ostium  415 . The balloon dilatation catheter is then expanded to apply an omnidirectional force that dilates the opening  415  of the paranasal sinus  418 . The balloon catheter dilatation remodels both the sinus ostium  415  tissues and bone adjacent to the sinus ostium  415 , without invasive procedures such as incisions of the mucosa or removal of any bone. The balloon dilatation catheter and guide are then removed and the dilated sinus ostium  415  allows for improved drainage from and ventilation of the paranasal sinus  418 . Depending on the patient and physical differences in the nasal cavity from patient to patient, a conventional Balloon Sinuplasty™ may be challenging or impossible. The paranasal sinuses  418  lie between the upper parts of the nasal cavities and the eye orbits, and are separated from these cavities by delicate, thin bony laminae. In that location, the paranasal sinuses  418  are in close proximity to delicate structures such as the optic nerve, extraocular muscles that move the eyes, the eye orbits, brain, meninges, and nasolacrimal duct. Due to the complex and delicate anatomy of the aforementioned structures and differences from patient to patient, a balloon dilatation catheter that applies omnidirectional force on the surrounding structure during a procedure has the potential of causing damage to the delicate structures surrounding the paranasal sinuses. 
         [0087]    In order to protect the delicate structures surrounding the paranasal sinuses, the devices  100 ,  200 ,  300  of the present disclosure can be utilized. For example, the balloon dilatation catheter  100  illustrated in  FIG. 2A  and  FIGS. 5A-5D  and  6 A- 6 D can be advanced through the guide  406  and over the flexible wire  403  to the opening  415  of the target sinus  418 . As the balloon  124 ′ is inflated, the force distribution member  127 ′ generally shields the delicate structures, or the structures surrounding a delicate structure by directing the force applied by the dilatation of the balloon  124 ′ towards other directions as illustrated in  FIG. 2F  and  FIG. 2G . 
         [0088]    Generally, as determined empirically when the balloon  124 ′ is inflated, the external surface of the balloon  124 ′ parallel and opposite to the force distribution member  127 ′ is approximately one third of the size of the external side surface of the force distribution member  127 ′. Similarly, the balloon dilatation catheter  200  illustrated in  FIG. 2A  may be advanced through the guide  406  and over the flexible wire  403  to the opening  415  of the target sinus  418 . As the balloon  209 ′ is inflated, the force-directional member  206  generally shields the delicate structures, or the structures surrounding a delicate structure by directing the force applied by the dilatation of the balloon  124 ′ towards other directions as illustrated in  FIG. 3F  and  FIG. 3G . 
         [0089]    Generally, when the balloon  209 ′ is inflated, both the force-directional member  206  and the external surface of the balloon  209 ′ parallel and opposite to the force-directional member  206  apply pressure on a section of tissue or physical structure in the nasal cavity  412 . Preferably, the area of the balloon  209 ′ that applies pressure to a physical structure is approximately a third of the area of the force-directional member  206  that applies pressure to a physical structure in the nasal cavity  412 . Finally, the force-directional device  300  illustrated in  FIG. 4A  can be used with traditional balloon dilatation catheters used in a sinuplasty procedure, where a traditional balloon is advanced through the shaft  303  and mounted on the force-directional member  312 . In one aspect, both the balloon dilatation catheter and the force-directional device  300  can be advanced through the guide  406  and over the flexible wire  403  to a target opening  415  of a sinus  418 . As the balloon is inflated, the force-directional member  312  directs the force applied by the dilatation of the balloon away from the delicate structures. 
         [0090]      FIG. 7  is a schematic of a balloon dilatation device comprising a wedge which is driven forward upon inflation of the balloon. As shown in  FIG. 7 , the balloon dilatation catheter  400  comprises a balloon  402  located at the distal end of a shaft  118 . As shown in  FIG. 7 , a force application member  404  is positioned at the distal end of the balloon  402 . Balloon  404  expands laterally (i.e., in the proximal-distal direction with respect to the shaft) upon inflation. Upon inflation of the balloon, force application member  404  is driven forward, away from the shaft  118 . As shown in  FIG. 7 , force application member  404  can have a wedge shape wherein the thickness of the member increases in the distal to proximal direction. In use, force application member  404  is positioned anterior of the area to be treated such that, upon inflation, force application member  404  is driven forward relative to shaft  118  and into a position adjacent the area to be treated. As shown in  FIG. 7 , force application member  404  is attached to the distal end of balloon  404 . Force application member  404 , however, can also be movably attached to shaft  118  forward of the balloon in such a manner as to allow axial separation from the shaft. 
         [0091]      FIG. 8  is a schematic of a balloon dilatation device comprising first and second wedge elements which are forced apart by the inflation of the balloon. As shown in  FIG. 8 , balloon dilatation catheter  500  comprises a balloon  502  located at the distal end of a shaft  118 . The device also includes first and second wedge elements  504  and  506 . As shown in  FIG. 8 , first and second wedge elements  504  and  506  are movably attached to shaft  118  to allow separation upon inflation of balloon  502 . As also shown in  FIG. 8 , both wedge elements have an outer convex surface. However, first wedge element  504  has a greater degree of curvature than second wedge element  506 . Accordingly, upon inflation of balloon  502 , first wedge element  504  will apply greater pressure to adjacent tissue than second wedge element  506 . In use, second wedge element  506  can be positioned adjacent anatomical structures susceptible to damage in order to reduce the pressure applied to such structures during treatment. While first and second wedge elements having curved outer surfaces are shown in  FIG. 8 , these surfaces may be flat or have other shapes. 
         [0092]    In certain patients with certain nasal anatomy or in in complex anatomical situations, such as irregularities in the nasal cavity  412 , the devices described herein can be used to modify the anatomy of the nasal cavity  412  either momentarily or permanently. In one aspect, the modification of the anatomy of the nasal cavity by the devices described herein can allow easier manipulation of medical instruments inside of the nasal cavity  412  during medical procedures, such as sinuplasty and septoplasty. During a septoplasty procedure, for example, the devices as described herein can be used to hold the necessary space open in the nasal cavity  412 , and the flattened surface of the devices  100 ,  200 ,  300  aid in creating a flattened surface nearby that improves the working surface for conducting the septoplasty tissue removal. 
         [0093]    The foregoing description of the exemplary embodiments has been presented only for the purposes of illustration and description and is not intended to be exhaustive or to limit the inventions to the precise forms disclosed. Many modifications and variations are possible in light of the above teaching. 
         [0094]    The embodiments were chosen and described in order to explain the principles of the disclosure and their practical application so as to enable others skilled in the art to utilize the inventions and various embodiments and with various modifications as are suited to the particular use contemplated. Alternative embodiments will become apparent to those skilled in the art to which the present disclosure pertain without departing from their spirit and scope.

Technology Category: 1