Abstract:
Methods and devices for rhinoplasty and treating nasal valve stenosis are disclosed herein. The nasal valve acts as a flow-limiter and can contribute to airway obstruction if resistance within the nasal valve is excessive. In one embodiment, a system for treating nasal valve stenosis includes a first elongate implant and a second elongate implant configured to support the nasal valves when implanted. The implants can be coupled together by connecting elements, such as eyelets, tethers, complementary socket joints, and button-rivet supports.

Description:
REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 60/817,565 filed Jun. 29, 2006 and No. 60/875,067 filed Dec. 15, 2006. Both of the priority applications are hereby incorporated by reference in their entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    Embodiments of the present invention disclose devices and methods for treating the collapse of structures within the nose that form the passageways for airflow during inhalation. 
         [0004]    2. Description of the Related Art 
         [0005]    The airflow resistance provided by the airways during breathing is essential for good pulmonary function. The nose is responsible for almost two thirds of this resistance. Most of this resistance occurs in the anterior part of the nose. This region is called the nasal valve, and it acts as a flow-limiter. 
         [0006]    The nasal valve was originally described by Mink in 1903. It is divided into external and internal portions. The external nasal valve is formed by the columella, the nasal floor, and the nasal rim (or caudal border of the lower lateral cartilage). The nasalis muscle dilates this portion during inspiration. The internal nasal valve accounts for the larger part of the nasal resistance. It is located in the area of transition between the skin and respiratory epithelium, and it is usually the narrowest part of the nose. The internal nasal valve is the better-known valve and is often referred to as the nasal valve. 
         [0007]    The two terms should be differentiated because the internal nasal valve or “nasal valve” accounts only for the aperture between the nasal septum and the caudal border of the upper lateral cartilage (ULC). The angle formed between them is normally between about 10°-15°. 
         [0008]    The nasal valve area is formed by the nasal septum, the caudal border of the ULC, the head of the inferior turbinate, and the pyriform aperture and the tissues that surround it. This area is responsible for more than two thirds of the resistance produced by the nose. 
         [0009]    In 1894, Franke performed nasal-flow experiments in models and cadavers and found that whirl formation occurred near the head of the turbinate during calm breathing. The term nasal valve was first coined by Mink in 1903. He developed this concept further in 1920, suggesting that the greatest area of resistance was in the limen nasi or the union of the lobular cartilage and ULCs. 
         [0010]    In 1940, Uddstromer found that 70% of the resistance of the nose was produced in the nasal valve area and the remaining 30% was due to the nasal fossa. Van Dishoeck further investigated the mechanisms of the nasal valve in 1942, and in 1970, Bridger and Proctor wrote about a “flow-limiting segment” that included the limen nasi and the pyriform aperture. In 1972, Bachman and Legler found the pyriform aperture to have the smallest cross-sectional area of the nasal airway. 
         [0011]    In 1983, Haight and Cole continued the study of Bridger and Proctor and demonstrated that the maximal nasal resistance was localized near the pyriform aperture and depended on engorgement of the head of the inferior turbinate. 
         [0012]    As many as 13% of the patients with chronic nasal obstruction have nasal valve collapse. Of these patients, 88% have unilateral collapse. 
         [0013]    External nasal valve collapse is often found in patients who do not have a history of trauma or surgery. These patients commonly have an overprojecting nose with extremely narrow nostrils. Another cause can be an extremely wide columella. 
         [0014]    Types of internal nasal valve collapse can be differentiated depending on the structure that caused the collapse. In many cases, more than one structure is affected. The most common cause is probably septal deviation. The second cause is collapse secondary to rhinologic surgery, especially after removal of the nasal roof. 
         [0015]    In 1987, Kasperbauer and Kern developed a comprehensive classification; however, the classification below depends on the anatomical area. 
         [0016]    Deviations of the caudal septum are the most common cause of valvular collapse. They are usually secondary to trauma. The septum can be overly thick in the valvular area, decreasing the space in it. Also, an absence of cartilage in this area leaves a flaccid septum that moves during inspiration. 
         [0017]    Thickened cartilage can compromise an adequate aperture. The cartilage can also be twisted, deflected, or associated with excessive return of the caudal border. An absence of cartilage, either congenital or iatrogenic, can produce a flaccid valve that collapses during inspiration. 
         [0018]    Overresection during rhinoplasty can weaken the cartilage and cause inspiratory collapse. Deformation of the cartilage can be a result of trauma or congenital malformations of the cartilage. 
         [0019]    Trauma or previous surgery can create webs or stenosis in the valvular area. The tissue can also be too thick, reducing the lumen of the valve. This can be a result of inflammation or hypertrophy. 
         [0020]    Hypertrophy of the inferior turbinate can significantly increase nasal resistance. Several studies have demonstrated that the head of the turbinate is responsible for most of this increase. In comparison, the body and tail of the turbinate play minor roles in nasal resistance. The increase in size can be secondary only to mucosa or bone hypertrophy. 
         [0021]    Although uncommon, some patients may have deformities of the pyriform aperture that reduce the space of the nasal valve. The first description the authors found of a congenital stenosis of the pyriform aperture was made by Brown et al in 1988; other reports have followed, such as Ramadan, 1995; Fornelli, 2000; and Lee, 2002. A more common cause of obstruction is the osteotomy made during a rhinoplasty. In particular, the type known as low-to-low is blamed for excessive narrowing of the pyriform aperture. Some modifications to this procedure allow an osteotomy to be performed without compromising the space in the valve. 
         [0022]    Rhinoplastic procedures are particularly prone to disturbing the nasal valve area. Hump removal affects the nasal valve in several ways. If the hump is particularly large, separation of the ULC can be necessary. Resection of the T-shaped area of the dorsal border of the septum produces a narrower area in the roof. If the mucosa in the valve is not protected during the surgery, which occurred with the use of many older techniques, scarring of the valve can lead to structure formation or stenosis of the valve. In reduction rhinoplasties, the cross-sectional area of the overall nose is reduced. This increases the resistance to airflow. If the nasal valve is not properly repaired during the surgery, patients may report nasal obstruction after the surgery, even if this was not reported preoperatively. Overresection of the lower lateral cartilage can lead to pinching and inspiratory collapse. 
         [0023]    Age is another factor to consider. The relaxation of tissues may eventually produce a flaccid valve. In these cases, surgery of the valve can correct the loss of patency. 
         [0024]    The internal nasal valve works as a flow-limiting area. The fixed part of the valve is composed of the septum and the pyriform aperture. The ULC and the mucosa of the turbinate act as the mobile part. When air is inspired, it is forced through this narrow area, increasing its speed and pressure. Just after passing the valve, the air expands in the bony cavum, creating turbulence that promotes contact between the air and the mucosa. In this way, the inspired air is cleansed of particles, humidified, and heated or cooled (depending on its temperature). 
         [0025]    Because it is the narrowest part of the nose, the nasal valve can be affected by minute alterations of the nasal anatomy that would not be important in other areas. The angle between the ULC and the nasal septum is typically between about 10°-15°. Internal nasal valve collapse occurs when, for some reason, this angle is diminished. The result is an increase in nasal resistance to airflow; consequently, the patient reports nasal obstruction. The opposite is known as ballooning. In this case, the nasal valve is excessively open. 
         [0026]    The increase in nasal resistance is also related to abnormalities of pulmonary function. These changes in pulmonary function return to normal after septal surgery is performed and nasal resistance is decreased. 
         [0027]    Patients primarily report nasal obstruction. Other symptoms are crusting and bleeding, but these are more often associated with septal deviation. 
         [0028]    Diagnosis can be difficult if the physician does not visualize the valvular area. Examining the valve without disturbing it with a nasal speculum is important because the speculum usually opens the valve. Sometimes, trimming the vibrissae is necessary to obtain a clearer view of the valve. Another method is to use a 0° endoscope. 
         [0029]    The Cottle test is useful to evaluate nasal valve stenosis. The cheek of the evaluated side is gently pulled laterally with 1-2 fingers, which opens the valve. The examiner then asks the patient to breathe and evaluates if breathing is better before or after pulling the cheek. A positive test result is when the patient feels less resistance with the valve opened. This test is easy and quick to perform. 
         [0030]    The internal nasal valve is limited medially by the nasal septum. Laterally, in its superior part, it is limited by the caudal border of the ULC, where it forms the limen nasi with the cephalic border of the lobular cartilage. The angle between the septum and the ULC is generally between about 10°-15° in patients of Caucasian descent. Patients of other ethnic backgrounds can demonstrate great variability in this septum-ULC angle measurement. In this area, epithelium shifts from the skin of the vestibule to the respiratory mucosa of the bony cavum. 
         [0031]    The pyriform aperture continues the limit of the valve from the ULC to the floor. The head of the inferior turbinate is immediately posterior to the pyriform aperture and plays an important role in the function of the valve, which is the reason it is also considered part of the internal nasal valve. In some patients, particularly white persons, the caudal border of the ULC scrolls externally in what is called the returning of the ULC. When this returning is excessive, it can produce valve collapse. 
         [0032]    In addition to the typical reasons to avoid surgery (e.g., bleeding disorders), other contraindications include excessive scarring due to multiple previous surgeries, which may compromise the outcome of the procedure, the presence of cheloid scarring, and unrealistic patient expectations. 
         [0033]    Imaging studies such as CT scanning of paranasal sinuses can be performed to, for example, obtain coronal views which can provide good information on the patency of the nasal valve, especially the area under the nasal dorsum (nasal valve area), which is sometimes difficult to visualize. However, these studies are expensive and should not be considered a substitute for comprehensive physical examinations. 
         [0034]    Other diagnostic tests that can performed include rhinomanometry and acoustic rhinometry. Rhinomanometry aids in evaluating the airflow resistance offered by each cavity but does not provide information about the location of the obstruction. Acoustic rhinometry is relatively new, as it was introduced in the late 1980s, and it can provide information about the cross-sectional area of the nose and about the position of obstructions. Results from the anterior portion of the nose tend to be more accurate than results from the posterior portion, making this test particularly suitable for evaluating the valve. Acoustic rhinometry can be used to evaluate the symmetry of nasal areas. 
         [0035]    The nasal valve is better explored without instruments because tools can open the valve and produce the false impression that the area is normal. A headlight and an endoscope are the only necessary instruments to examine the nasal valve. In many male patients (and some females), the vibrissae are thick, making direct visualization of the area difficult. If this occurs, one option is to trim them until the valve can be visualized. 
         [0036]    The Cottle test is a good method to examine the vestibular portion of the nasal valve. It consists of pulling the nasolabial fold upward and laterally and asking the patient if breathing is better. An affirmative answer implies that a collapse of the valve is present on that side. A negative answer means the cause of the obstruction is elsewhere in the nose. A false-positive result can occur in patients with collapse of the nasal ala. False-negative results are observed in patients with scars or webs in the valve that prevent it from opening. False-negative results also occur in those with narrowing of the pyriform aperture secondary to congenital malformation or after an excessive narrowing of the nasal base with an osteotomy. 
         [0037]    When the valvular collapse is secondary to inflammation of the mucosa covering the valve (e.g., secondary to allergic rhinitis or infection), proper treatment, such as anti-inflammatory agents or antibiotics, can help remedy the problem. 
         [0038]    Collapse secondary to mechanical obstruction is more common. In this case, surgery is the only solution. Some patients use a self-adhesive stent that opens the nasal valve; however, this is only a temporary solution. 
         [0039]    Several surgical techniques are used to correct a stenotic or collapsed nasal valve. Depending on the type of pathology, the surgeon can choose to use one or several methods. The scope of techniques varies from sutures to the application of grafts. The common goal is to open the valve, restoring the appropriate anatomy. Explaining each technique is beyond the scope of this article; however the following is a summary of these techniques depending on the structure modified. 
         [0040]    A valvuloplasty is the surgery historically used to reconstruct the nasal valve. The goal of this surgery is to open the valve by removing the returning ULC and trimming the caudal border of the cartilage. It is not the only technique used to correct valvular alterations, but it provides an excellent view of the caudal border of the ULC and can be used in conjunction with other techniques. Because the valve is formed by several different structures, other techniques may be necessary, depending on the type of deformity that produced the stenosis. 
         [0041]    The goal of this procedure is to expose the caudal border of the ULC to correct any deformity (e.g., resection of the caudal border of the ULC, excessive returning of the ULC). The following preliminary steps can be taken when performing this procedure: expose the caudal border of the ULC through an intercartilaginous incision, avoid damaging the valvular mucosa in order to decrease the risk of a synechia, and place intercartilaginous incisions 1-2 mm caudal to the border of the ULC. The area of transition from skin to respiratory epithelium is prone to developing unwanted scarring or synechiae. Then the following steps can be taken: 
         [0042]    Undermine the skin over the dorsum. 
         [0043]    To obtain better exposure, gently retract the alar margin of the nostril with a 10- or 12-mm double hook. 
         [0044]    Grasp the caudal border of the ULC with an Adson-Brown or similar forceps. 
         [0045]    Dissect the mucosa in the underside of the ULC with the tip of a Walter or curved Iris scissors. 
         [0046]    Similarly separate the upper side of the ULC from the subcutaneous tissue until the caudal border is completely visible. 
         [0047]    Repeat the same procedure if the dorsum is visible from both sides. 
         [0048]    Almost any deformity of the ULC can be identified this way. 
         [0049]    If a septoplasty or rhinoseptoplasty was performed and the caudal border of the septum was resected, resect a similar amount of the caudal border of the ULC. This maintains the proportions between the septum and the ULC. 
         [0050]    Resection of the caudal border of the ULC reduces its flexibility. To maintain it, removing a small triangle near the septum may be necessary. 
         [0051]    If another deformity is present, direct surgery to correct it. For example, if the ULC is twisted, a batten may be necessary to straighten it. 
         [0052]    Spreader grafts can be inserted and fixed through this incision to increase the cross-sectional area of the nose. 
         [0053]    When intercartilaginous incisions do not allow enough space to see and work because of the complexity of the stenosis, an open approach provides excellent exposure (i.e., when spreader grafts and flaring sutures are applied in the same procedure). 
         [0054]    A dry field is important in this surgery because the space is limited and bleeding can obstruct the visual field and make the procedure time consuming. To avoid this, the cul-de-sac can be infiltrated 5-10 minutes prior to the incision. Apply only a small amount of lidocaine and epinephrine (Octocaine with epinephrine [2%], Xylocaine with epinephrine [2%]). Approximately 0.5 mL is needed in each valve to avoid distortion of the structures. Help from an assistant is invaluable. 
         [0055]    Suturing of the intercartilaginous incision is performed at the end of the surgery, when all other maneuvers have been completed. Some prefer to use catgut or 4-0 Vicryl with ophthalmic needles. These small curved needles are easy to handle in the confined space of the vestibule. 
         [0056]    Normal preoperative examinations can be performed, and no special care is required. The surgery is often performed in combination with septoplasty or rhinoseptoplasty. Local or general anesthesia can be used. 
         [0057]    Because the valve is formed by several structures, the surgery is directed toward realigning the obstructing parts. 
         [0058]    If a caudal deviation is causing the obstruction, a septoplasty can correct the problem. Septoplasty is a difficult surgery because caudal deviations are commonly complex deformities of the septal framework and obtaining a completely straight septum proves to be a frustrating task. In some cases, obtaining straight cartilage from the posterior septum and transplanting it is preferable. This is particularly true in those patients with horizontal fractures of the caudal septum (e.g., Chevallet fractures). The use of battens is sometimes necessary to keep the repaired septum straight. 
         [0059]    The nasal roof can be excessively narrowed after rhinoplasty or with congenital or traumatic deformities. In these cases, the use of spreader grafts, as described by Sheen in 1984, is particularly useful. They keep the nasal profile straight, and they also increase the cross-sectional area of the entire nasal valve. 
         [0060]    If the cartilage is thick or if excessive returning of the caudal border of the cartilage occurs, modification is possible by resecting the caudal border and reshaping the valve. This is commonly a surgery performed concomitantly with septoplasty. Also, the previously mentioned spreader grafts can modify the position of the cartilage, allowing the valve to open. In case the cartilage is absent, a graft can be fashioned from septal or auricular cartilage. Another method described to open the nasal valve is to apply a flaring suture that lifts the ULCs. A combination of both techniques has recently been reported to have the best results. The ULC can be sutured using several different techniques, including suspension sutures (Lee, 2001) and mattress sutures (Ozturan, 2002). 
         [0061]    When the alar cartilage is weakened after surgical overresection or trauma, its rigidity must be restored. The basic method consists of applying a batten of cartilage to keep the lobule rigid during inspiration. A method described by O&#39;Halloran in 2003 consists of the removal of excessive skin in the valvular area through an incision anterior to the LLC. 
         [0062]    Although complete resection of the turbinate is best avoided, conservative resection (or manicuring) of the head of the turbinate significantly decreases the total resistance offered by the internal valve. This procedure, when performed properly, is a useful tool when the other areas are difficult to correct. Unless hypertrophy is extremely large, resecting more than 2 cm from the head typically is not necessary because the airflow follows a superior direction afterwards. 
         [0063]    Narrow pyriform apertures should be handled depending on the origin of the constriction. Congenital pyriform stenosis can be produced from an excess of bone. This bone can be drilled away through a sublabial approach. If the stenosis was produced by an excessive narrowing of the nasal bones in a previous surgery, it can be handled with resection of a small wedge of bone in the narrowest area. Another approach is to displace the bones laterally (outfracture) after performing new osteotomies. In this case, performing medial and lateral osteotomies is recommended. If neither procedure is successful, conservative resection of the head of the inferior turbinate is an alternative plan. In many patients, more than one procedure is necessary to open the valve. 
         [0064]    This situation is difficult to handle. Obstructive scarring is common after surgery. Resection of the synechia or scarring is performed with scissors. Because some synechia and scars are quite thick, a good method is to clamp the valve with a forceps for 5 minutes before the procedure in order to obtain better hemostasis. Good results have been obtained by separating both sides of the valve with a silicone sheet (Silastic). Because the author routinely uses silicone (Silastic) splints for septal surgery, the splint must simply be cut into a proper shape and size and then sutured to the septum with nylon 3-0 or 4-0 suture. A contralateral splint is recommended to avoid unnecessary damage to the mucosa. 
         [0065]    Incisions can be closed with 4-0 catgut or Vicryl, preferably with ophthalmic needles to facilitate the closure. A typical dressing can be applied to the rest of the nose, depending on the surgery performed (e.g., dressing and cast for rhinoplasty). 
         [0066]    The need for hospitalization following these types of procedures depends on the type of anesthesia used, the recovery of the patient, and the evaluation of the physician. Because the procedures are primarily performed in combination with septoplasty, the same care used following septoplasty is applicable for these procedures. 
         [0067]    Thus, there remains an unmet need in the art for non-traumatic, non-surgical treatments for the collapse of structures within the nose that form the passageways for airflow. 
       SUMMARY OF THE INVENTION 
       [0068]    In some embodiments, disclosed herein is a system for supporting a nasal valve. The system can include a first elongate implant configured to support a first nasal valve; a second elongate implant configured to support a second nasal valve; and means for connecting the first elongate implant to the second elongate implant. The means for connecting the first elongate implant to the second elongate implant can include complementary socket joints on the first elongate implant and the second elongate implant. In other embodiments, the means for connecting the first elongate implant to the second elongate implant include an eyelet located on the first elongate implant and an eyelet located on the second elongate implant, and a tether for connecting the eyelets. In other embodiments, the means for connecting the first elongate implant to the second elongate implant include an eyelet located on the first elongate implant and a split eyelet located on the second elongate implant. In still other embodiments, the means for connecting the first elongate implant to the second elongate implant can include an interlocking button-rivet support. 
         [0069]    Also disclosed herein is a system for supporting a nasal valve, including a first elongate implant that includes a first connecting element; and a second elongate implant that includes a second connecting element. The first connecting element and the second connecting element are configured to be operably connected to each other such that the system supports a nasal valve. In some embodiments, the first connecting element includes a male socket joint and the second connecting element includes a female socket joint configured to be coupled to the male socket joint. In some embodiments, at least one of the first connecting element and the second connecting element includes an eyelet. In some embodiments, the first connecting member includes a first eyelet and the second connecting member includes a second eyelet. The system also preferably includes an elongate member configured to pass through the first eyelet and the second eyelet to secure the first elongate member to the second elongate member. The elongate member can be, for example, a rivet, a tether, or the like. 
         [0070]    A method of supporting a nasal valve is also disclosed. The method includes the steps of providing a first elongate implant; inserting the first elongate implant to a first position adjacent a first nasal valve to support the first nasal valve; providing a second elongate implant; and inserting the second elongate implant to a second position adjacent a second nasal valve to support the second nasal valve. Inserting the first elongate implant can include creating an access pathway near the nasal bridge. The method can also include connecting the first elongate implant to the second elongate implant. 
         [0071]    Connecting the first elongate implant to the second elongate implant can involve securing a portion of the first elongate implant and the second elongate implant together using a tether. Securing a portion of the first elongate implant and the second elongate implant together using a tether can include threading the tether through an eyelet located on the first elongate implant and an eyelet located on the second elongate implant. In other embodiments, connecting the first elongate implant to the second elongate implant involves threading a split eyelet located on the second elongate implant through a solid eyelet located on the first elongate implant, and securing the split eyelet to the solid eyelet. In other embodiments, connecting the first elongate implant to the second elongate implant involves connecting a socket portion of the first elongate implant to a complementary socket portion of the second elongate implant. In still other embodiments, connecting the first elongate implant to the second elongate implant includes passing an elongate rod through an aperture on the first elongate implant and an aperture on the second elongate implant. 
         [0072]    Also disclosed is a method of suspending a nasal valve, including the steps of providing a delivery cannula, the cannula comprising a nasal suspension assembly housed within a working lumen of the cannula, the nasal suspension assembly comprising a tissue anchor and a tether operably connected to the tissue anchor; creating an incision on a facial region of a patient; passing the delivery cannula through the incision in proximity to the orbital rim; retracting the delivery cannula to expose the tissue anchor and the tether; deploying the first anchor within a tissue layer within a lateral wall of a nasal passage; and securing the tether near the orbital rim to support the nasal valve. The facial region of a patient can be, for example, in proximity to the infraorbital rim. In some embodiments, the method further includes the step of passing the delivery cannula through a nostril of the patient prior to passing the delivery cannula through the incision. In some embodiments, the delivery cannula includes a curved distal tip portion. The tissue anchor can include a tissue-ingrowth surface. The tissue anchor can also be an expandable tissue anchor. The tissue layer can be, for example, mucosa, cartilage, dermis, or subcutaneous fascia. Securing the tether line can involve securing the tether line to a bony structure, or alternatively, to soft tissue. 
         [0073]    Also disclosed is a method of suspending a nasal valve, including the steps of providing a nasal suspension system comprising a first tissue anchor, a second tissue anchor, and a tether operably connected to the first tissue anchor and the second tissue anchor; deploying the first tissue anchor within a first soft tissue layer within a wall of a nasal passage; deploying the second tissue anchor within a second soft tissue layer; and tensioning the tether to suspend the nasal valve. Tensioning of the tether to suspend the nasal valve can occurs prior to, after, or concurrently with deploying the second tissue anchor within the second soft tissue layer. In some embodiments, the method also includes the steps of providing a delivery cannula, the cannula including the nasal suspension system housed within a working lumen of the cannula; passing the delivery cannula through a nostril to a desired location to suspend the nasal valve; and retracting the delivery cannula to expose the nasal suspension system. The second tissue layer can be in any clinically desirable location, such as, for example, in the vicinity of the infraorbital rim. The second tissue layer can be, for example, the mucosa, cartilage, dermis, or subcutaneous fascia. In some embodiments, the first tissue anchor and the second tissue anchor are expandable tissue anchors. In some embodiments, the delivery cannula includes a curved distal tip portion. In some embodiments, the method also includes the step of adjusting the tension of the nasal suspension system after deployment of the system. Adjusting the tension of the nasal suspension system after deployment of the system can be accomplished by an adjustment element disposed along a portion of the nasal suspension system. 
         [0074]    Also disclosed is a kit for suspending the nasal valve, including: a nasal suspension system configured to support a nasal valve once implanted, the nasal suspension system comprising: a first tissue anchor; a second tissue anchor; an elongate member configured to be connected to the first tissue anchor and the second tissue anchor; and a delivery cannula configured to house the nasal suspension system within a working channel of the delivery cannula. At least one of the first tissue anchor and second tissue anchor can be expandable tissue anchors. Furthermore, at least one of the first tissue anchor and second tissue anchor can include a tissue in-growth surface. The delivery cannula can include a curved distal portion. 
         [0075]    In some embodiments, disclosed is a system for suspending a nasal valve, including: a first tissue anchor configured to be attached to a lateral wall of a nasal passage; and an elongate member configured to be attached to the first tissue anchor and the second tissue anchor, the elongate member also configured to suspend a nasal valve. The system can also include a second tissue anchor configured to be attached to another structure on a facial region. The first tissue anchor can be an expandable tissue anchor. The first tissue anchor can also include a tissue ingrowth surface. In some embodiments, the system also includes an adjustment element configured to adjust the tension of the elongate member. The adjustment element can be configured to adjust a tension of the elongate member while the elongate member is connected to the first tissue anchor and the second tissue anchor. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0076]      FIG. 1A  shows a nasal suspension assembly being deployed through the nostrils using a cannula containing a tether line and collapsed anchor at the proximal end of the tether line, according to one embodiment of the invention. 
           [0077]      FIG. 1B  shows a deployed nasal suspension assembly, after the cannula has been removed, tension has been applied to the tether line, and the anchor has been deployed, according to one embodiment of the invention. 
           [0078]      FIG. 2  shows a nasal suspension assembly being deployed in which the anchor has a tissue in-growth surface, according to one embodiment of the invention. 
           [0079]      FIG. 3  shows a deployed nasal suspension assembly with anchors at both ends of the tether line, according to one embodiment of the invention. 
           [0080]      FIG. 4  shows a nasal suspension assembly being deployed from a location near the eye using a curved cannula with a plunger at its proximal end, according to one embodiment of the invention. 
           [0081]      FIG. 5  shows the insertion of a needle under the surface of the nose to deploy an implant, according to one embodiment of the invention. 
           [0082]      FIG. 6  shows an implant deployed across the bridge of the nose, according to one embodiment of the invention. 
           [0083]      FIG. 7  shows a nasal valve implant with a two-piece splint design, according to one embodiment of the invention. 
           [0084]      FIG. 8  shows implantation of two separate battens as a two-piece splint, according to one embodiment of the invention. 
           [0085]      FIGS. 9A-9C  show another embodiment of a two-piece nasal splint 
           [0086]      FIGS. 10A-10B  show an embodiment of a two-piece nasal support. 
           [0087]      FIGS. 11A-11C  show another embodiment of a two-piece nasal support. 
       
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
     Nasal Suspension 
       [0088]    U.S. patent application Ser. No. 11/349,067, filed Feb. 7, 2006, published as U.S. Patent Publication No. 2006/0207608 A1 on Sep. 21, 2006 and incorporated by reference in its entirety, describes methods and devices for manipulating the airway, as does U.S. Patent Publication No. 2006/0276817 to Vassallo et al., hereby incorporated by reference in its entirety, an article by David Nunez-Fernandez, M.D. et al.,  Rhinoplasty, Internal Valve Stenosis,  available at www.emedicine.com/ent/topic115.htm, and an article by Michael Friedman, M.D. et al.,  Nasal Valve Suspension: An Improved, Simplified Technique for Nasal Valve Collapse,  January 2003, available at www.chicagoent.com/pdf/Nasal_Valve_Simpl.pdf. Both of the articles are hereby incorporated by reference in their entirety. In some embodiments of the present invention, collapse of structures within the nose that form the passageways for airflow is treated by deploying a nasal suspension assembly  100  within the nose  124  and thereby suspending nasal structures and opening a site of nasal collapse, such as nasal valve  122 , as shown in  FIGS. 1A-1B . Nasal suspension assembly  100  may comprise one or more anchors  104  and a tether line  108 . Anchors  104  may be attached to mucosa, cartilage, dermis, or any connective tissue layer within the lateral walls of the nasal passages  212 . Tether line  108  may be attached to the orbital rim  112  or to any structures near orbital rim  112  or between orbital rim  112  and nose  124  that are less mobile than nose  124 . For example, tether line  108  can be attached to bones, periosteum, or soft tissue. Tension can subsequently be applied to tether line  108  to suspend nasal structures and thereby open the site of nasal collapse. 
         [0089]    In one embodiment, nasal suspension assembly  100  is deployed by creating an incision  128  at the orbital rim  112  and passing a cannula  116  from the nostrils  120  of nose  124  under the surface of the skin  154  to incision  128  as shown in  FIG. 1A . Cannula  116  comprises a needle tip  144  at distal end  156  and a working lumen  140  that extends from proximal end  148  of cannula  116  to distal end  156  of cannula  116 . An anchor  104  is attached to the proximal end  152  of tether line  108  and tether line  108  is pre-loaded into cannula  116  by passing the tether line  108  from the proximal end  148  of cannula  116  through lumen  140  and through needle tip  144  so that the distal end  160  of tether line  108  emerges from the distal end  156  of cannula  116 . Anchor  104  is retained within cannula  116  in a collapsed state. Cannula  116  is subsequently passed from nostrils  120  to incision  128 , exiting incision  128  with distal end  160  of tether line  108  emerging from the surface  164  of the skin. Cannula  116  is then retracted proximally, leaving tether line  108  extending out of incision  128  as anchor  104  is released from cannula  116  and deployed within the mucosa, cartilage, dermis, or connective tissue layer within the lateral walls of the nasal passages  212 , depending on the desired clinical result, in an uncollapsed state. Tension is then applied to tether line  108 , for example by pulling on the end of tether line  108  extending out of incision  128 . Tether line  108  is then secured so that nasal structures are suspended and the site of nasal collapse is opened as shown in  FIG. 1B . Tether line can be secured with knots, crimps, clamps, adhesives, and any other mechanisms as would be understood by those skilled in the art. Incision  128  can subsequently be closed using a variety of mechanisms as would be contemplated by those skilled in the art, for example, with sutures. One advantage of deploying nasal suspension assembly  100  by introducing cannula  116  through nose  124  is that there are no facial structures near the proximal end  148  of cannula  116  that need to be avoided. In the method discussed below cannula  116  is introduced near the eye  176 , and thus a curved needle tip  144  is used to avoid facial structures. 
         [0090]    As shown in  FIG. 2 , in some embodiments anchor  104  comprises a tissue in-growth surface  172 . Tissue in-growth surface  172  could enhance attachment of anchor  104  to tissue within the lateral walls of the nasal passages  212 , particularly when anchor  104  has a very low profile. For example, a material that promotes tissue in-growth could cover at least a portion of the surface of anchor  104 . This material could include various biocompatible materials, including ePTFE, Dacron, bioresorbable materials, polyethylene, and other materials as would be contemplated by those skilled in the art. 
         [0091]    In another embodiment, anchors  104  are placed at both proximal end  152  and distal end  160  of tether line  108 , as shown in  FIG. 3 . Both anchors  104  are contained in a collapsed state within cannula  116 . Cannula  116  is then introduced into nostrils  120  and advanced until its distal end  156  reaches an area sufficiently lateral or towards the eye, such as adjacent to orbital rim  112 . Then cannula  116  is withdrawn and anchors  104  are deployed in an uncollapsed state in soft tissue thereby opening the nasal valve  122 . Distal end  156  should be advanced to an area sufficiently lateral such that anchors  104  are spaced apart when deployed in the soft tissue so as to create the tension required to suspend the nasal valve  122 , as shown in  FIG. 3 . Tension can be applied to tether line  108  either before the second anchor  104  is delivered or after both anchors  104  are delivered. In some embodiments, the length of tether line  108  between anchors  104  is fixed such that after the first anchor  104  is deployed and while the second anchor  104  still resides within cannula  116 , cannula  116  is pulled to apply tension to first anchor  104  and tension line  108 . In some embodiments, after both anchors  104  are deployed, tension is applied to tension line  108  by pulling on the portion of tension line  108  extending out of the distal end  156  of cannula  116 . A mechanism can be employed to allow pulling of tension line  108  in the direction towards the eye only, and not in the opposite direction such that tension line  108  could be withdrawn back into cannula  116 . This mechanism can comprise a lock or zip-tie or any other means disclosed in the applications and articles incorporated by reference in their entireties supra or any other means that would be contemplated by those skilled in the art. One or more of the anchors  104  may comprise a tissue in-growth surface  172 . This embodiment does not require an anchor  104  or screw or other retaining means to be placed in the bone. Another advantage associated with this embodiment is that incision  128  near the eye  176  does not need to be made. 
         [0092]    In yet another embodiment, as shown in  FIG. 4 , cannula  116  is introduced into the site of nasal collapse from near the eye  176 . This method of introducing cannula  116  and subsequently deploying nasal valve suspension assembly  100  is similar to Friedman&#39;s technique which involves a transconjunctival approach that provides easy access to the infraorbital rim on patients who refuse a facial incision. (See article by Michael Friedman, M.D. et al.,  Nasal Valve Suspension: An Improved, Simplified Technique for Nasal Valve Collapse,  January 2003, available at www.chicagoent.com/pdf/Nasal_Valve_Simpl.pdf, incorporated by reference in its entirety supra.) In this embodiment, cannula  116  has a curved configuration so as to avoid facial structures as described above and as shown in FIG.  4 . An anchor  104  is threaded over the distal end  160  of tether line  108  and tether line  108  is passed from the proximal end  148  of cannula  116  through lumen  140 . Anchor  104  is retained within cannula  116  in a collapsed state. Cannula  116  is subsequently passed from the eye to the site of nasal collapse. Plunger  188  is then actuated such that anchor  104  emerges from needle tip  144  and is deployed at the site of nasal collapse in an uncollapsed state. 
       Implantable Nasal Valve Support 
       [0093]    In another embodiment, an implant  192  can be deployed within nose  124  across the bridge  196  as shown in  FIGS. 5 and 6  to open the site of nasal collapse. 
         [0094]    In some embodiments, implant  192  is a relatively stiff elongate bar which can have a straight or bent configuration or a variety of other configurations depending on the desired clinical outcome. Implant  192  is biased when deployed to lift tissue on either side  224  of bridge  196 , thereby opening the site of nasal collapse. A deployed implant  192  is depicted in  FIG. 6 . Implant  192  can comprise woven Dacron, ePTFE, polyethylene, or any other material as would be contemplated by those skilled in the art. Implant  192  can also be configured as a metallic strip or wire comprising Nitinol, titanium, stainless steel, or other metallic materials depending on the desired clinical outcome. In some embodiments implant  192  comprises a tissue in-growth surface  172  comprising ePTFE, Dacron, and other materials as would be contemplated by those skilled in the art. Implant  192  may also comprise a bioresorbable surface comprising materials as would be contemplated by those skilled in the art. 
         [0095]    In one embodiment, implant  192  is delivered through a delivery needle  204  as shown in  FIG. 5 . Delivery needle  204  is inserted into one side  224  of nose  124  lateral to nostrils  120  and under and parallel to the surface of nose  124 . As needle  204  approaches bridge  196  it is angled to run parallel to the contralateral side  224  of nose  124 . In some embodiments, bridge  196  is manually depressed and/or the nares are manually elevated to assist in angling of needle  204 . Needle  204  is advanced to contralateral side  224  and then retracted while implant  192  is simultaneously extruded from needle tip  228 . Implant  192  is thereby deployed across bridge  196  as shown in  FIG. 6  and lifts tissue on either side  224  of bridge  196  to open the site of nasal collapse. This lifting of tissue is similar to the effect obtained with a BREATHE-RIGHT® strip (Johnson &amp; Johnson). 
       Two-Piece Nasal Valve Splints 
       [0096]    In some embodiments minimally invasive implantation of nasal valve supports is facilitated by use of a two-piece splint design. Each piece of the two-piece design is inserted adjacent to one of the nasal valves through a small hole on the surface of the nose. After each piece is inserted, the two pieces are attached to obtain a configuration that supports the nasal valves. In some embodiments, the hole should preferably be at or near the bridge of the nose to provide a straight line-of-sight access path for the insertion needle/cannula into the nose along the nasal valve. Implantation of each piece separately prior to assembly is much less invasive than implantation of the two-piece assembly because each linear piece can be inserted through a small hole. 
         [0097]      FIG. 7  shows a cross-sectional view of a “socket joint” type two-piece splint  232  comprising pieces  236  and  252 . The socket end  256  of piece  236  comprises a ring-like portion  244  with a central lumen  248 . Piece  252  comprises a complimentary end  260  that fits into lumen  248  of socket end  256  such that pieces  236  and  252  are locked together. Pieces  236  and  252  are implanted separately and then locked together after implantation. When assembled, splint  232  provides biasing support to prevent collapse of the nasal valves. Each splint is preferably splayed at an angle about equal to or greater than the natural angle of the nasal opening (nare). The splints serve to stabilize a weak or easily collapsible valve by stiffening it, or enlarging the existing opening which will reduce resistance and decrease the propensity for the valve to collapse. The splint can be made of a wide variety of materials as known in the art. In some embodiments, the splint is made of a silicone material if relatively less stiffening is desired. In other embodiments, the splint can be made of a metal such as titanium, stainless steel, and the like if more support or enlargement is needed and hence more stiffness. In one preferred embodiment, the splint is formed from titanium with a thin silicone covering. 
         [0098]      FIG. 8  shows implantation of two separate battens  260  as another two-piece nasal splint  268 . As seen in  FIG. 8 , one batten  260  is implanted adjacent one nasal  262  valve and the second batten  260  is implanted adjacent the other nasal valve  262  to suspend each collapsing valve  262 . Each batten  260  is inserted using a needle  272 . The needle is then preferably removed in order to remove a potentially trauma-inducing surface. Battens  260  can be formed of materials with a desired stiffness so as to achieve suspension of the nasal valves  262  as would be understood by those skilled in the art. In some embodiments, the batten may be formed of materials that allow tissue ingrowth such as woven Dacron, porous ePTFE, and the like. If tissue ingrowth is not required or desired, for example, in cases where significant scarring and fibrosis is not desirable, silicone, solid PTFE, FEP, and the like can used to create the batten. Alternatively, the scar tissue and fibrosis that form following implantation of battens  260  can provide the necessary stiffness to achieve suspension of the nasal valves  262  either independently or in combination with the stiffness of battens  260 . 
         [0099]      FIGS. 9A-9C  show another embodiment of a two-piece nasal splint  276  which comprises two parts  280 . Each part  280  comprises a head section  284  having a lumen adapted to receive suture  282 .  FIG. 9A  shows parts  280  each placed adjacent one nasal valve  262 .  FIG. 9B  shows head sections  284  aligned following insertion of parts  280  into the nasal valves  262 . When head sections  284  are placed adjacent to each other, suture  282  can be passed through each section  284  and tied such that sections  284  are drawn tightly together as shown in  FIG. 9C . When head sections  284  are aligned and tied together as shown in  FIG. 9C , parts  280  of the splint are biased such that they suspend the nasal valves  262  and prevent collapse. After sections  284  are tied together, suture  282  is buried in the nasal tissue. 
         [0100]    Another embodiment of a two-piece nasal support  288  is shown in  FIGS. 10A-10B . Piece  292  comprises an eyelet  296  large enough to allow end  300  of second piece  304  to pass through as shown in  FIG. 10B . End  300  is configured like an eyelet open at its end and split such that it may be snapped or tied over the shaft portion  308  of piece  292 . Eyelet  296  and end  300  are angled with respect to the shaft portions  308  of pieces  292  and  304  as shown in  FIG. 10A  so as to allow angulation of shaft portions  308 . The angles between eyelet  296  and end  300  and their respective shaft portions  308  can be fixed or altered as desired by the surgeon or other user at the time of implantation to obtain a customized fit. A nasal support  288  can be preferably formed from a superelastic material such as Nitinol so that it can be ejected from a needle or cannula. The wire can be formed as shown with the proximal eyelets constrained in the needle in a relatively straight configuration. An incision can be created at the bridge of the nose and a small flap created, under which the eyelets will eventually be placed. The needle is inserted along the desired axis of suspension along the margin of the nares or nasal valve and ejected from the needle. The needle is most preferably inserted deep enough to allow the eyelet of each splint to be contained underneath the tissue flap at the end of the procedure. After both splints are deployed, the split eyelet is attached to the solid eyelet. To facilitate the attachment, the physician can slide the splints slightly upward in the tract created by the needle. After the eyelets are attached, the splints are pressed back down into their respective tracts and the conjoined eyelets are buried in the incision or under the tissue flap. A pocket can be created if needed depending on the size of the eyelets and the bulk of the nose tissue available to cover the connection. 
         [0101]    In another embodiment of a two-piece nasal support, the support is configured as a button rivet support  312  as shown in  FIGS. 11A-11C . Each piece  316  of support  312  comprises a head portion  320  with a hole  324  such that when head portions  320  are placed one on top of the other and holes  324  are aligned, a rivet  328  can be passed through holes  324  to attach pieces  316  as shown in  FIG. 11A .  FIG. 11B  is a side view of support  312  after assembly.  FIG. 11C  is a plan view of support  312  after assembly. Head portions  320  are angled with respect to each other to allow alignment of holes  324  and with respect to the shafts  332  of each piece  316  to create the desired valve suspension after assembly. These angles may differ for particular patients and may be modified accordingly as would be understood by those skilled in the art. 
         [0102]    While this invention has been particularly shown and described with references to embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention. For all of the embodiments described above, the steps of the methods need not be performed sequentially.