Abstract:
An apparatus, system, and method are disclosed for medializing the middle turbinate following sinus surgery, thus preventing synacheiae, granulation tissue, and other complications of the prior art. The apparatus utilizes a fastening device configured to attach the middle turbinate to the nasal septum, a prong comprising a slender wand portion and a fastening module, and a handle configured to trigger deployment of the fastening means by activating the fastening module. The fastening device may be a staple, rivet, glue, or another similar device.

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS  
       [0001]     This application is a continuation-in-part of and claims priority to U.S. Provisional Patent Application No. 60/509,509 entitled “MIDDLE TURBANITE MEDIALIZER” and filed on Oct. 8, 2003 for Bryan C. Tagge. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     1. Field of the Invention  
         [0003]     This invention relates to devices for surgery and more particularly relates to devices for sinus and nasal surgery.  
         [0004]     2. Description of the Related Art  
         [0005]     Adherence of the middle turbinates to the lateral wall of the nasal cavity is a common post-operative problem following sinus surgery performed on either the maxillary ethmoid sphenoid or frontal sinuses. This condition, known as synechiae, blocks the middle meatus, or opening to the sinuses, causing persistent sinusitis and sinus disease.  
         [0006]     Development of synechiae can require lysing to separate the middle turbinate from the lateral nasal wall. This can be performed under local anesthesia in a doctor&#39;s office or under general antisthetic, using endoscopic visualization. It is, however, an additional surgical procedure, inconvenient and often painful for the patient.  
         [0007]     Attempts to avoid this problem include placement of a middle meatus spacer consisting of dissolvable or non-dissolvable packing positioned to medialize the turbinate away from the lateral wall. Packing, however, can foster the growth of granulation tissue as the body&#39;s inflammatory response to a foreign body. Granulation tissue can cause persistent sinus disease. Another medializing technique employs sutures to secure the middle turbinates to the septum. Placement of the sutures, however, is a time consuming and painstaking process.  
         [0008]     Existing surgical instruments such as bowel staplers are not adapted to the environment of the nasal cavity. The existing septum stapling instruments are narrow enough to enter the nasal cavity but are not configured with attachment means of sufficient length and otherwise appropriate to secure the middle turbinate.  
         [0009]     From the foregoing discussion, it should be apparent that a need exists for an apparatus, system, and method for reliably medializing the middle turbinate away from the middle meatus with its opening to the sinus. Beneficially, such an apparatus, system, and method would be time effective for the physician as well as safe and comfortable for the patient.  
       SUMMARY OF THE INVENTION  
       [0010]     The present invention has been developed in response to the present state of the art, and in particular, in response to the problems and needs in the art that have not yet been fully solved by currently available surgical instruments. Accordingly, the present invention has been developed to provide an apparatus, system, and method for medializing the middle turbinate that overcome many or all of the above-discussed shortcomings in the art.  
         [0011]     The apparatus to medialize the middle turbinate is provided with a fastening module attached to a slender prong configured to enter the nasal cavity. The prong is attached to a handle configured for manipulation of the prong and also configured to activate the fastening module. The prongs are configured to be slender enough to enter the nasal cavity, with the space between them sufficiently wide to accommodate the septum and middle turbinates.  
         [0012]     The apparatus, in one embodiment, is configured to enter the nasal cavity between the middle turbinate and lateral wall of the cavity and staple the middle turbinate to the septum.  
         [0013]     The apparatus is further configured, in one embodiment, to enter the nasal cavity between the septum and middle turbinate and staple septal membranes, or mucoperichondrial flaps following septoplasty or removal of deformed septal bone and cartilage.  
         [0014]     In a further embodiment, the apparatus may be configured to rivet the middle turbinate to the septum. In another embodiment the apparatus may be configured to deploy staples or rivets composed of absorbable or non-absorbable material. In an additional embodiment the apparatus may be configured to suture the middle turbinate to the septum. In yet another embodiment the apparatus may be configured to attach the middle turbinate to the septum via adhesive. In one additional embodiment the apparatus may be configured to attach the middle turbinate to the septum via cauterization.  
         [0015]     A system of the present invention is also presented to medialize the middle turbinate. The system may be embodied in the combination of the fastening module, fastening means, prongs and activation handle of the apparatus. In particular, the system, in one embodiment, includes a fastening module configured to staple the middle turbinate to the septum. In a further embodiment the system may include staples comprised of a bioabsorbable material.  
         [0016]     The system may further include the fastening module configured to rivet the middle turbinate to the septum. In a further embodiment the system may include rivets comprised of a bioabsorbable material. The system may also include the fastening module configured to suture the middle turbinate to the septum.  
         [0017]     The system may further include the fastening module configured to attach the middle turbinate to the septum via adhesive. In a further embodiment the system may include the prong configured with an inner extension configured to apply the adhesive and an outer extension configured to press the middle turbinate against the septum during setting of the adhesive.  
         [0018]     The system may further include the fastening module configured to attach the middle turbinate to the septum via cauterization. In a further embodiment the system may include the prong configured with a heatable inner extension configured perform the cauterization and an outer extension configured to press the middle turbinate against the septum following cauterization. In a further embodiment the system may include a removable clamp configured to hold the middle turbinate in place during adhesion of the cauterization.  
         [0019]     The system may further include equipment for direct or remote endoscopic visualization of the placement of the fastening means.  
         [0020]     A method of the present invention is also presented for medializing the middle turbinate. The method in the disclosed embodiments substantially includes the steps necessary to carry out the functions presented above with respect to the operation of the described apparatus and system. In one embodiment, the method includes preparing the patient, providing the apparatus, inserting the prongs and fastening module of the apparatus in the nasal cavity, activating the fastening module, placing the fastening means, and removing the apparatus. The method also may include placing a removable clamp to hold the turbinate against the septum following cauterization.  
         [0021]     In a further embodiment, the method includes direct or remote endoscopic visualization of the procedure.  
         [0022]     Reference throughout this specification to features, advantages, or similar language does not imply that all of the features and advantages that may be realized with the present invention should be or are in any single embodiment of the invention. Rather, language referring to the features and advantages is understood to mean that a specific feature, advantage, or characteristic described in connection with an embodiment is included in at least one embodiment of the present invention. Thus, discussion of the features and advantages, and similar language, throughout this specification may, but do not necessarily, refer to the same embodiment.  
         [0023]     Furthermore, the described features, advantages, and characteristics of the invention may be combined in any suitable manner in one or more embodiments. One skilled in the relevant art will recognize that the invention may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments of the invention.  
         [0024]     These features and advantages of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0025]     In order that the advantages of the invention will be readily understood, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments that are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered to be limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which: In order that the manner in which the advantages of the invention will be readily understood, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered to be limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:  
         [0026]      FIG. 1  is perspective view of one embodiment of a middle turbinate medializer in accordance with the present invention;  
         [0027]      FIG. 2  is a perspective view with a cut away illustrating the anatomy of a nasal cavity;  
         [0028]      FIG. 3  is a perspective view with a cut away illustrating one embodiment of a middle turbinate medializer fastening the middle turbinates of two nasal cavities to a septum;  
         [0029]      FIG. 4  is a perspective view with a cut away illustrating two middle turbinates fastened to a septum;  
         [0030]      FIG. 5  is a perspective view with a cut away illustrating a nasal cavity with a normal septum;  
         [0031]      FIG. 6  is a perspective view with a cut away illustrating a nasal cavity with a deviated septum;  
         [0032]      FIG. 7  is a perspective view with a cut away illustrating a septum with the cartilage or bony portion removed after septoplasty;  
         [0033]      FIG. 8  is a perspective view with a cut away illustrating one embodiment of a middle turbinate medializer fastening a mucoperichondrial flap of the septum to another mucoperichondrial flap;  
         [0034]      FIG. 9  is a perspective view with a cut away illustrating a nasal cavity with the mucoperichondrial flaps fastened together with a staple.  
         [0035]      FIG. 10  is a perspective view of an embodiment of the prongs of a turbinate medializer configured to insert a rivet;  
         [0036]      FIG. 11  is a perspective view of an embodiment of the prongs of a turbinate medializer configured to apply a suture;  
         [0037]      FIG. 12  is a perspective view of an embodiment of the prongs of a turbinate medializer configured to apply adhesive;  
         [0038]      FIG. 13  is a perspective view of an embodiment of the prongs of an adhesive configured turbinate medializer inserted in a nasal cavity;  
         [0039]      FIG. 14  is a perspective view of an embodiment of the prongs of an embodiment of a cauterizing turbinate medializer;  
         [0040]      FIG. 15  is a perspective view of a nasal clamp securing the middle turbinates during adhesion of the cauterization; and  
         [0041]      FIG. 16  is a schematic flow chart diagram illustrating a method in accordance with the present invention.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0042]     The invention is a medical instrument, specifically, a middle turbinate medializer. In effect, the medializer is a modification of surgical devices used to attach body tissues following surgery and during healing. The device of the present invention, however, is adapted to being placed up the nose.  FIG. 1  illustrates one embodiment of a middle turbinate medializer  100  of the present invention. The medializer  100  is forked, as shown, and comprises a handle  112 , two prongs  114 , and a fastening module  116  on each prong  114 . The fastening module  116  in one embodiment receives a fastener such as a staple  118  and a base  120 . The staple  118  is held by one prong  114  and the base held on the other prong  114 . The staple  118  is preferably configured to be sufficiently long to pass through one middle turbinate, the septum, and the opposite middle turbinate, in order to attach the middle turbinates to the septum. The handle  112 , activates the fastening module. In one embodiment the placement of the staple is performed under direct or remote endoscopic visualization.  
         [0043]     Referring now to  FIG. 2 ,  FIG. 2  illustrates the general anatomy of a nasal cavity  200 . When sinus surgery classically known as FESS for Functional Endoscopic Sinus Surgery is conducted, the sinus cavity is accessed through sinus opening  202  under the middle turbinate  204 . When the surgery is completed, the middle turbinate  204  often bonds to the exterior wall of the nasal cavity  100 , blocking the sinus opening  202  and preventing proper aeration and draining of the sinus.  
         [0044]     To prevent this, a number of known processes are conducted, including abrading the medial surface of the middle turbinate  204  and the septum  206  of the nose and inserting packing material between the outer wall of the nasal cavity and the middle turbinate  204  so that the middle turbinate  204  will bond to the septum  206 . This method has disadvantages, however, including patient discomfort and the tendency of packing to foster the growth of granulation tissue. To improve upon this, surgeons have stitched the two middle turbinates  204  together to the septum  206 . However, this is a time consuming task, and the stitches are required to be removed afterward.  
         [0045]     The present invention  100  enters into the nose with one prong  14  inserted in each nasal cavity  200  as illustrated in  FIG. 3 , and is used to staple, suture, or otherwise fasten the two middle turbinates  204  to each other and to the middle septum  206 . In some cases both middle turbinates  204  are fastened to the septum  206 , though in other cases only a single middle turbinate  204  may be fastened to the septum  206 . Accordingly, when in operation, the trigger  122  ( FIG. 1 ) is pulled, and the staple  118  is fastened to the base  120  through the septum  206  and middle turbinates  204 , as illustrated in  FIG. 4 . In one embodiment, the staple  118  or suture is dissolvable and may be formed of an absorbable copolymer staple, as is well known in the art.  
         [0046]     The operation prevents lateralization of the middle turbinate  204 , with resulting adhesion and obstruction of the sinus opening  202  which is called synechiae. Furthermore, the invention may be used in various applications to correct nasal conditions. One such application may include fastening together various parts of the septum after septoplasty. Septoplasty is an operation that alters or removes portions of the supporting structures in the septum in order to correct defects or deformities in the nose. One example of a defect is a deviated septum.  
         [0047]      FIG. 5  illustrates a nasal cavity  200  with a normal septum  206 . The ideal nasal septum  206  is exactly midline and divides the left and right sides of the nose into passages of equal size. The supporting structure  208  is usually composed of cartilage or bony tissue and is covered by a membrane  210 .  
         [0048]     A deviated septum  206  occurs when the septum  206  is severely shifted away from the midline as illustrated in  FIG. 6 . In severe cases, a deviated septum  206  may block the nasal passage, consequently hindering breathing through the nose and contributing to frequent sinus infections. To treat this defect, septoplasty is usually performed, thereby removing the problematic areas of the supporting structure  208 .  
         [0049]      FIG. 7  illustrates a nasal cavity  200  with a portion of the cartilage/bony structure  208  removed from the septum  206 . During the procedure, the membranes  210  are cut away from the hard tissue  208 , forming mucoperichondrial flaps  210 , which traditionally are sutured together; again, a difficult, time consuming task. However, the middle turbinate medializer  100  of the present invention may be used to reapproximate both mucoperichondrial flaps  210  after septoplasty.  
         [0050]      FIG. 8  illustrates a middle turbinate medializer  100  inserted through the nostrils to fasten the mucoperichondrial flaps  210  in place to allow the septum  206  to heal and return to a midline position.  FIG. 9  depicts a staple  118  securing the flaps  210  of the septum  206 . Of course, any number of staples  118  or sutures may be introduced to the nasal cavity using the present invention.  
         [0051]     In a further embodiment, the medializer  100  may operate as a rivet gun which is pressed into one or both nasal cavities  100 , and in effect, the turbinate  104  is riveted in place.  FIG. 10  is a schematic drawing depicting the fastening ends  116  of prongs  114  filled with a rivet  1002  and a rivet receiver  1004 . In a further embodiment the rivet may be comprised of bioabsorbable material.  
         [0052]     Sutures may be fastened in a like manner.  FIG. 11  is a schematic drawing depicting a needle,  1102 , mounted perpendicularly to a prong  114 . A thread  1106  passes through a thread guide  1108 , through a needle eye  1104  and back through tread guide  108 . A hole  1110  on the opposite prong  114  communicates with a bobbin assembly  1112  carrying bobbin thread  1114 . In the depicted embodiment the prongs are inserted into the nasal cavity and the needle  1104  is activated, piercing the turbinates and septum, passing through the hole  1110  and engaging the bobbin  1112 , causing the thread  1106  to loop and knot with the bobbin thread  1114 , forming a suture. In a further embodiment the suture is placed under direct endoscopic visualization. In a further embodiment the suture may be performed with bioabsorbable thread.  
         [0053]     Various types of tissue adhesive may also be applied to secure the turbinate to the septum.  FIG. 12  depicts an embodiment in which hollow rods  1202  deposit adhesive  1206  between the turbinate and the septum. Pressure pads  1204  mounted on prongs  114  then close against the turbinates, holding them against the septum while the adhesive sets.  FIG. 13  depicts the device in place in a nasal cavity  200 . Adhesive  1206  flows through hollow rods  1202  to be deposited between the middle turbinates  204  and the septum  206 . In one embodiment rods deposit the adhesive and then withdraw. Pressure pads  1204  hold the turbinates  204  against the septum  206  during the setting of the adhesive.  
         [0054]     Cauterization may also create an adhesion between the middle turbinates and the septum.  FIG. 14  depicts an embodiment of a cauterization iron. Heat wands  1402  carry heat tips  1404 . Pressure pads  1204  hold the turbinate and septul tissues against the heat tips during cauterization. In a further embodiment a temporary clamp  1502  holds the middle turbinates against the septum while the burns adhere as illustrated in  FIG. 15 .  
         [0055]      FIG. 16  is a schematic block diagram depicting a method in accordance with the present invention and comprising the steps of: preparing a patient for surgery  1604 ; providing the turbinate medializer device  1606 ; inserting the prongs of the device into the nasal cavity  1608 ; activating the handle of the device to apply the fastener to the turbinates; and withdrawing the device.  
         [0056]     All of the above procedures may be applied to a single turbinate or a pair of turbinates with equal effectiveness. The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive.