Abstract:
The present invention relates to apparatus ad methods for correcting nasal valve collapse comprising a device configured for suspending a nasal valve, the device comprising a body portion comprising a proximal end, a distal end, and a plurality of barbs, wherein the body portion is configured to be inserted through or underneath the upper lateral cartilage of a patient and wherein the plurality of barbs are configured to engage a soft tissue overlying a bony tissue proximal to the upper lateral cartilage, and a head portion coupled to the proximal end of the body portion wherein the head portion is configured to engage the upper lateral cartilage of the patient when the plurality of barbs are engaged with the soft tissue overlying the bony tissue proximal to the upper lateral cartilage

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority to U.S. Provisional Patent Application Ser. No. 61/116,112, filed Nov. 19, 2008, entitled “Apparatus and Methods for Correcting Nasal Valve Collapse”, the entire disclosure of which is specifically incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present disclosure relates generally to devices, systems and methods for correcting a nasal valve collapse and/or stabilizing lateral nasal cartilage. 
       BACKGROUND INFORMATION 
       [0003]    Nasal valve collapse is a frequent and sufficient cause of nasal airway obstruction, characterized by a loss of support from lateral nasal cartilages typically observed following rhinoplasty, nasal trauma or in aged patients. Properly functioning nasal cartilage acts to keep the nasal passages open. If the lateral cartilages become weak, they collapse inward when a person inhales due to the negative pressure from the flow of air. This problem is currently largely untreated due to the complexity and highly variable results associated with current repair techniques, combined with the fact that a majority of patients are elderly or have a history of nasal surgery. These complex surgical procedures have been developed to correct valve collapse by reinforcing the lateral cartilages so adequate support can permit valve opening and thus eliminate the nasal airway obstruction. 
         [0004]    However, many of these procedures require surgically opening the nose to replace structurally insufficient tissue with either synthetic or autologous tissue grafts. Results of these procedures have been highly variable and drawbacks include the lack of sufficient autologous grafting tissue, significant infection and extrusion of synthetic grafts, the potential for altering facial aesthetics and possible confounding effects on other nasal functionality. Another method for repairing nasal valve collapse, developed by Friedman et al., involves a bone-anchor suspension technique whereby a suture is anchored to the orbital rim and placed subcutaneously so as to loop through the upper lateral cartilage. Instead of imparting structural integrity to the collapsed cartilage, it applies tensile forces through this suture to prevent further collapse. Although the procedure has shown some promise, very few surgeons perform the technique because of the technical difficulties and potential complications. Complications occur because patients develop granulomas due to suture proximity to the nasal mucosa, which eventually necessitates implant removal. 
         [0005]    Overall, nasal valve collapse is an oftentimes untreated problem due to inconsistent results from a myriad of very complex procedures performed by very few surgeons. As such, there remains a need for an endoscopic method to repair nasal valve in a simple, consistent manner. 
       SUMMARY 
       [0006]    Exemplary embodiments of the present disclosure comprise a device configured for suspending a nasal valve. In certain embodiments, the device comprises a body portion comprising a proximal end, a distal end, and a plurality of barbs. The body portion can be configured to be inserted through or underneath the upper lateral cartilage of a patient and the plurality of barbs configured to engage the soft tissue overlying bony tissue proximal to the upper lateral cartilage. Certain embodiments may comprise a head portion coupled to the proximal end of the body portion, where the head portion is configured to engage the upper lateral cartilage of the patient when the plurality of barbs are engaged with the soft tissue overlying bony tissue proximal to the upper lateral cartilage. 
         [0007]    In certain embodiments, the head portion is coupled to the body portion to form a “T” shape, while in other embodiments the head portion is coupled to the body portion to form an “L” shape or a hook shape. The plurality of barbs can be distributed along one side of the body portion and may be directed toward the proximal end of the body portion. In specific embodiments, the body portion and head portion are separated by an angle of between 90 and 120 degrees, more specifically between 95 and 115 degrees, and more specifically still between 100 and 110 degrees. In certain other embodiments, the body portion and head portion are separated by an angle of between 60 and 20 degrees, more specifically between 55 and 25 degrees, and more specifically still between 50 and 30 degrees. 
         [0008]    Other embodiments comprise a method of stabilizing the upper lateral cartilage of a patient. The method may comprise: creating an aperture in the mucosa of the patient; inserting a device with a body portion and a head portion into the aperture, where the body portion of the device is inserted into the aperture prior to the head portion; advancing the device into the aperture so that the head portion engages the upper lateral cartilage of the patient; and engaging the plurality of barbs into soft tissue overlying the bony tissue proximal to the upper lateral cartilage. Specific embodiments may include engaging the plurality of barbs into soft tissue overlying the bony tissue lateral to the upper lateral cartilage, including, for example, the maxilla of the patient. 
         [0009]    In certain embodiments, the body portion of the device pierces the upper lateral cartilage of the patient, and in other embodiments the body portion of the device is inserted between the upper lateral cartilage of the patient and bony tissue proximal to the upper lateral cartilage. In specific embodiments, the device is inserted into the aperture using a guiding needle sheath. 
         [0010]    In certain embodiments, engaging the plurality of barbs into the soft tissue overlying the bony tissue proximal to the upper lateral cartilage of the patient comprises pressing down on an epidermal tissue proximal to the device. In specific embodiments, the soft tissue overlying the bony tissue is part of the orbital bone, while in other embodiments, the bony tissue is part of the nasal bone. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]      FIG. 1  illustrates a perspective view of a nasal valve suspension device according to an exemplary embodiment of the present disclosure. 
           [0012]      FIG. 2  illustrates a perspective view of the embodiment of  FIG. 1  in an exemplary installed position. 
           [0013]      FIG. 3  illustrates a perspective view of a nasal valve suspension device according to an exemplary embodiment of the present disclosure. 
           [0014]      FIG. 4  illustrates a perspective view of the embodiment of  FIG. 2  in an exemplary installed position. 
           [0015]      FIG. 5  illustrates side and top views of a nasal valve suspension device according to an exemplary embodiment of the present disclosure. 
           [0016]      FIG. 6  illustrates side and top views of a nasal valve suspension device according to an exemplary embodiment of the present disclosure. 
           [0017]      FIG. 7  illustrates a front view of the embodiment of  FIG. 5  in an exemplary installed position. 
           [0018]      FIG. 8  illustrates a side view of the embodiment of  FIG. 5  in an exemplary installed position. 
       
    
    
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 
       [0019]    Referring initially to the exemplary embodiment shown in  FIG. 1 , a nasal valve suspension device (NVSD)  100  is configured in a “T”-shape comprising a head portion  110  and a body portion  120  having a proximal end  122  and a distal end  124 . A plurality of barbs  130  are disposed along body portion  120  so that the pointed ends of each barb are directed towards proximal end  122  (and head portion  110 ) and away from distal end  124 . In certain embodiments, body portion  120  may be 0.5 to 3.0 cm in length, and head portion  110  may be approximately 0.5 centimeters in length. 
         [0020]    In exemplary embodiments, intranasal endoscopic placement of NVSD  100  may be employed to allow NVSD  100  to support the nasal cartilage and prevent collapse of the nasal valve. In certain embodiments NVSD  100  may comprise a non-bioabsorbable material. In other embodiments, NVSD  100  may comprise a bioabsorbable material. Based on the material used to construct NVSD  100 , the device can provide structural support while new tissue attachments are formed, and NVSD  100  may remain or degrade over time. 
         [0021]    Referring now to  FIG. 2 , NVSD  100  may be installed in an intranasal method by forming a slit or aperture  170  in the mucosa of a patient. Aperture  170  should be sized large enough to allow NVSD  100 , including head portion  110 , to pass through aperture  170 . NVSD  100  can be inserted through aperture  170  so that body portion  120  is first inserted and head portion  110  follows. In this embodiment, NVSD  100  is oriented so that barbs  130  are facing down (e.g. towards the bone underlying the upper lateral cartilage and away from the epidermis). Body portion  120  can then be advanced to penetrate the upper lateral cartilage of the patient until head portion  110  engages the upper lateral cartilage. NVSD  100  can then be further advanced until head portion  110  exerts the desired amount of tension on the upper lateral cartilage. 
         [0022]    When the desired amount of tension has been exerted on the upper lateral cartilage, the surgeon can press down on the epidermis above NVSD  100  so that barbs  130  engage the periosteum of the bone tissue lying lateral to the upper lateral cartilage (e.g., the orbital bone). When the surgeon releases the pressure exerted on NVSD  100 , barbs  130  will remain engaged with the periosteum and will maintain the position of NVSD  100 . Head portion  110  of NVSD  100  will continue to maintain a force exerted on the upper lateral cartilage and will stabilize the lateral cartilage (e.g., restrict the upper lateral cartilage from deflecting inwards) when the patient inhales. 
         [0023]    Other embodiments of an NVSD may comprise a different configuration from that shown in  FIGS. 1-2 . Referring now to  FIGS. 3-4 , another exemplary embodiment of an NVSD is configured generally as a hook shape rather than the “T” shape of the previous embodiment. In the embodiment shown in  FIGS. 3-4 , NVSD  200  comprises a head portion  210  and a body portion  220  having a proximal end  222  and a distal end  224 . Head portion  210  and body portion  220  are spaced apart from each other at an angle  215 . In certain embodiments, angle  215  is between approximately 60 degrees and 20 degrees. In specific embodiments, angle  215  is between 55 degrees and 25 degrees, and in more specific embodiments angle  215  is between 50 and 40 degrees. A plurality of barbs  230  are disposed along body portion  220  so that the pointed ends of each barb are directed towards proximal end  222  (and head portion  210 ) and away from distal end  224 . 
         [0024]    As shown in  FIG. 4 , this embodiment can be installed through a mucosal aperture  270  so that NVSD  200  either penetrates or is placed above the superior aspect of the upper lateral cartilage. NVSD  200  can be installed so that body portion  220  is inserted first and barbs  230  are facing towards the bony tissue of the nasal bone. The surgeon can advance NVSD  200  so that head portion  210  engages the upper lateral cartilage. When the desired amount of tension has been placed on the upper lateral cartilage, the surgeon can press down on the epidermis above NVSD  200  so that barbs  230  engage the periosteum of the bone tissue below. Both NVSD  200  and NVSD  300  may be installed in either of the positions shown in  FIGS. 2 and 4 . 
         [0025]    Referring now to  FIG. 5 , another exemplary embodiment of an NVSD is similar to that shown in  FIG. 3 , but comprises generally an “L” shape (when viewed from the side), rather than a “hook” shape. In the embodiment shown in  FIG. 5 , NVSD  300  comprises a head portion  310 , a body portion  320  having a proximal end  322  and a distal end  324 . Head portion  310  and body portion  320  are spaced apart from each other at an angle  315 . In certain embodiments, angle  315  is between approximately 90 degrees and 120 degrees. In specific embodiments, angle  315  is between 95 degrees and 115 degrees, and in more specific embodiments angle  315  is between 100 and 110 degrees. A plurality of barbs  330  are disposed along body portion  320  so that the pointed ends of each barb are directed towards proximal end  322  (and head portion  310 ) and away from distal end  324 . 
         [0026]    Referring now to  FIG. 6 , another exemplary embodiment of an NVSD is similar to that shown in  FIG. 5 , but comprises a head portion  410  that is slightly curved. NVSD  400  comprises head portion  410 , a body portion  420  having a proximal end  422  and a distal end  424 . Head portion  410  and body portion  420  are spaced apart from each other at an angle  415 . A plurality of barbs  430  are disposed along body portion  420  so that the pointed ends of each barb are directed towards proximal end  422  (and head portion  410 ) and away from distal end  424 . The embodiment in  FIG. 6  can be installed in the same manner as the embodiment of  FIG. 5 , described below. 
         [0027]    As shown in  FIGS. 7 and 8 , NVSD  300  can be installed so that body portion  320  is installed through an aperture  570  in upper lateral cartilage  501 . Also visible in  FIGS. 7 and 8  are lower lateral cartilage  502  and accessory cartilage  503 . Head portion  310 , however, does not extend through aperture  570 , but instead remains under upper lateral cartilage  501 . Body portion  320  is inserted through aperture  570  sufficiently for head portion  310  to engage upper cartilage  501 . During installation, body portion  320  is oriented so that barbs  330  are facing towards the bone tissue proximal to body portion  320 . Similar to previous embodiments, the surgeon can press down on the epidermis above NVSD  300  so that barbs  330  engage the periosteum of the bone tissue lying lateral to the upper lateral cartilage  501  (e.g., the orbital bone). 
         [0028]    When the surgeon releases the pressure exerted on NVSD  300 , barbs  330  will remain engaged with the periosteum and will maintain the position of NVSD  300 . Head portion  310  of NVSD  300  will continue to maintain a force exerted on upper lateral cartilage  501  and will restrict upper lateral cartilage  501  from deflecting inwards when the patient inhales. Angle  315  between head portion  310  and body portion  320  is configured so that head portion  310  maintains a sufficient force on upper lateral cartilage  501  to restrict deflection during inhalation. 
         [0029]    As demonstrated in the above-described devices and methods, exemplary embodiments of this disclosure can be implemented to support nasal cartilage and keep the nasal passages open, particularly during inhalation. Exemplary embodiments utilize barbs that engage the periosteum of bone tissue proximal to the nasal cartilage and serve to maintain the device in the desired position. Exemplary devices also comprise a portion that engages the nasal cartilage and exerts a force against it that resists the collapse of the cartilage. 
       EQUIVALENTS AND SCOPE 
       [0030]    While an exemplary embodiment is described herein, it will be understood that various modifications to the method and apparatus can be made without departing from the scope of the present invention. For example, the positions of the control mechanisms may be varied from those illustrated. Furthermore, the sequential recitation of steps in any claim is not a requirement that the steps be performed in any particular order, unless otherwise so stated. 
         [0031]    The foregoing has been a description of certain non-limiting preferred embodiments of the invention. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. Those of ordinary skill in the art will appreciate that various changes and modifications to this description may be made without departing from the spirit or scope of the present invention, as defined in the following claims. For example, the positions of the control mechanisms may be varied from those illustrated. 
         [0032]    In the claims articles such as “a”, “an”, and “the” may mean one or more than one unless indicated to the contrary or otherwise evident from the context. Claims or descriptions that include “or” between one or more members of a group are considered satisfied if one, more than one, or all of the group members are present in, employed in, or otherwise relevant to a given product or process unless indicated to the contrary or otherwise evident from the context. The invention includes embodiments in which exactly one member of the group is present in, employed in, or otherwise relevant to a given product or process. The invention also includes embodiments in which more than one, or all of the group members are present in, employed in, or otherwise relevant to a given product or process. Furthermore, it is to be understood that embodiments of the invention encompasses all variations, combinations, and permutations in which one or more limitations, elements, clauses, descriptive terms, etc., from one or more of the claims or from relevant portions of the description is introduced into another claim. For example, any claim that is dependent on another claim can be modified to include one or more limitations found in any other claim that is dependent on the same base claim. Furthermore, where the claims recite a composition, it is to be understood that methods of using the composition for any of the purposes disclosed herein are included, and methods of making the composition according to any of the methods of making disclosed herein or other methods known in the art are included, unless otherwise indicated or unless it would be evident to one of ordinary skill in the art that a contradiction or inconsistency would arise. In addition, embodiments of the invention encompasses compositions made according to any of the methods for preparing compositions disclosed herein. 
         [0033]    Where elements are presented as lists, e.g., in Markush group format, it is to be understood that each subgroup of the elements is also disclosed, and any element(s) can be removed from the group. It is also noted that the term “comprising” is intended to be open and permits the inclusion of additional elements or steps. It should be understood that, in general, where the invention, or aspects of the invention, is/are referred to as comprising particular elements, features, steps, etc., certain embodiments of the invention or aspects of the invention consist, or consist essentially of, such elements, features, steps, etc. For purposes of simplicity those embodiments have not been specifically set forth in haec verba herein. Thus for each embodiment of the invention that comprises one or more elements, features, steps, etc., the invention also provides embodiments that consist or consist essentially of those elements, features, steps, etc. 
         [0034]    Where ranges are given, endpoints are included. Furthermore, it is to be understood that unless otherwise indicated or otherwise evident from the context and/or the understanding of one of ordinary skill in the art, values that are expressed as ranges can assume any specific value within the stated ranges in different embodiments of the invention, to the tenth of the unit of the lower limit of the range, unless the context clearly dictates otherwise. It is also to be understood that unless otherwise indicated or otherwise evident from the context and/or the understanding of one of ordinary skill in the art, values expressed as ranges can assume any subrange within the given range, wherein the endpoints of the subrange are expressed to the same degree of accuracy as the tenth of the unit of the lower limit of the range. 
         [0035]    In addition, it is to be understood that any particular embodiment of the present invention may be explicitly excluded from any one or more of the claims. Any embodiment, element, feature, application, or aspect of the compositions and/or methods of the invention can be excluded from any one or more claims. For purposes of brevity, all of the embodiments in which one or more elements, features, purposes, or aspects is excluded are not set forth explicitly herein. 
         [0036]    The following references are herein incorporated by reference:
   U.S. Pat. No. 4,461,281   U.S. Pat. No. 5,131,382   U.S. Pat. No. 5,531,744   U.S. Pat. No. 5,749,893   U.S. Pat. No. 5,785,647   U.S. Pat. No. 5,897,523   U.S. Pat. No. 6,010,054   U.S. Pat. No. 6,183,433   U.S. Pat. No. 6,656,195