Abstract:
According to one aspect of the present invention, an apparatus and related kit are disclosed for treating an airway condition of a patient. The invention includes a handle sized to be hand grasped by an operator and having an actuator mechanism to be selectively actuated by said operator. A cartridge includes an implant of biocompatible material sized to be embedded within a tissue of said airway. The cartridge also includes a needle having an axially extending bore and a distal tip for penetrating into the airway tissue. The implant disposed within said bore at the distal tip. The cartridge has a proximal end adapted to be coupled to the handle for the implant to be ejected from the distal tip upon actuation of the actuator. The kit of the invention includes a container including a handle and cartridge.

Description:
BACKGROUND  
       [0001]     1. Field of the Invention  
         [0002]     This invention is directed to an apparatus for treating an airway condition of a patient. More particularly, this invention is directed to an apparatus and related kit of a handle and cartridge for delivering an implant into tissue of a patient&#39;s airway.  
         [0003]     2. Description of the Prior Art  
         [0004]     Airway conditions such as snoring and obstructive sleep apnea (OSA) have received increased scientific and academic attention. One publication estimates that up to 20% of the adult population snores habitually. Huang, et al., “Biomechanics of Snoring”,  Endeavour , p. 96-100, Vol. 19, No. 3 (1995). Snoring can be a serious cause of marital discord. In addition, snoring can present a serious health risk to the snorer. In 10% of habitual snorers, collapse of the airway during sleep can lead to obstructive sleep apnea syndrome. Id.  
         [0005]     Notwithstanding numerous efforts to address snoring and sleep apnea, effective treatments have been elusive. Such treatment may include mouth guards or other appliances worn by the snorer during sleep. However, patients find such appliances uncomfortable and frequently discontinue use (presumably adding to marital stress).  
         [0006]     Electrical stimulation of the soft palate has been suggested to treat snoring and obstructive sleep apnea. See, e.g., Schwartz, et al., “Effects of electrical stimulation to the soft palate on snoring and obstructive sleep apnea”,  J. Prosthetic Dentistry , pp. 273-281 (1996). Devices to apply such stimulation are described in U.S. Pat. Nos. 5,284,161 and 5,792,067. Such devices are appliances requiring patient adherence to a regimen of use as well as subjecting the patient to discomfort during sleep. Electrical stimulation to treat sleep apnea is discussed in Wiltfang, et al., “First results on daytime submandibular electrostimulation of suprahyoidal muscles to prevent night-time hypopharyngeal collapse in obstructive sleep apnea syndrome”,  International Journal of Oral  &amp;  Maxillofacial Surgery , pp. 21-25 (1999).  
         [0007]     Surgical treatments have been employed. One such treatment is uvulopalatopharyngoplasty. In this procedure, so-called laser ablation is used to remove about 2 cm of the trailing edge of the soft palate thereby reducing the soft palate&#39;s ability to flutter between the tongue and the pharyngeal wall of the throat. The procedure is frequently effective to abate snoring but is painful and frequently results in undesirable side effects. Namely, removal of the soft palate trailing edge comprises the soft palate&#39;s ability to seal off nasal passages during swallowing and speech. In an estimated 25% of uvulopalatopharyngoplasty patients, fluid escapes from the mouth into the nose while drinking. Huang, et al., supra at 99. Uvulopalatopharyngoplasty (UPPP) is also described in Harries, et al., “The Surgical treatment of snoring”,  Journal of Laryngology and Otology , pp. 1105-1106 (1996) which describes removal of up to 1.5 cm of the soft palate. Assessment of snoring treatment is discussed in Cole, et al., “Snoring: A review and a Reassessment”,  Journal of Otolaryngology , pp. 303-306 (1995).  
         [0008]     Novel treatments for snoring and sleep apnea are described in various patents commonly assigned with the present application. These include U.S. Pat. No. 6,250,307 to Conrad et al. dated Jun. 26, 2001 which describes (along with other embodiments) elongated implants for placement in the soft palate. In one embodiment, three such implants are placed in the soft palate. U.S. Pat. No. 6,578,580 to Conrad et al. dated Jun. 17, 2003 describes a needle (which may have a perforated distal tip) for delivery of an implant. The implant may be preloaded into the needle. In U.S. Pat. No. 6,523,542 to Metzger et al. dated Feb. 25, 2003, an implant is described as a sheet of felt or similar material delivered through a needle. U.S. Pat. No. 6,513,530 to Knudson et al. dated Feb. 4, 2003 describes the implant as a braid with welded ends near frayed ends. U.S. Pat. No. 6,431,174 to Knudson et al. dated Aug. 13, 2002 describes use of microbeads as implants as well as describing placement of implants in a pharyngeal wall or nasal area as well as a soft palate.  
         [0009]     When placing implants in the tissue of a patient&#39;s airway (i.e., in soft palate, nasal or pharyngeal wall tissue), it may often be desirable to place more than one such implant (e.g., the three parallel longitudinal implants shown in the soft palate in the aforementioned U.S. Pat. No. 6,250,307). Delivery systems for such implants should accommodate the need for multiple implants, the need to protect the implant and delivery system from damage, facilitate ease and accuracy of implant placement and to maintain sterility. Also, such systems should be cost effective and minimize waste. It is an object of the present invention to provide such a delivery system.  
       SUMMARY OF THE INVENTION  
       [0010]     According to one aspect of the present invention, an apparatus and related kit are disclosed for treating an airway condition of a patient. The invention includes a handle sized to be hand-grasped by an operator and having an actuator mechanism to be selectively actuated by said operator. A cartridge includes an implant of biocompatible material sized to be embedded within a tissue of said airway. The cartridge also includes a needle having an axially extending bore and a distal tip for penetrating into the airway tissue. The implant is disposed within said bore at the distal tip. The cartridge has a proximal end adapted to be coupled to the handle for the implant to be ejected from the distal tip upon actuation of the actuator. The kit of the invention includes a container including a handle and cartridge. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]      FIG. 1  shows, in cross-section, a naso-pharyngeal area of an untreated patient;  
         [0012]      FIG. 2  shows a soft palate viewed through an open mouth of the untreated patient of  FIG. 1 ;  
         [0013]      FIG. 3  is a front view of an interior of the mouth shown in  FIG. 1  and showing an area to be ablated according to a first prior art surgical procedure;  
         [0014]      FIG. 4  is the view of  FIG. 3  and showing an area to be scarred according to a second prior art surgical procedure;  
         [0015]      FIG. 5  is a schematic representation of a spring-mass system model of the soft palate;  
         [0016]      FIG. 6  is perspective view of an implant for use with the present invention;  
         [0017]      FIG. 7  is a side elevation view of a prior delivery tool for delivery of the implant of  FIG. 6  into the soft palate of a patient;  
         [0018]      FIG. 8  is a side-sectional view of a distal tip of the tool of  FIG. 7  cut-away to reveal the implant of  FIG. 6  pre-loaded into the distal tip of the tool;  
         [0019]      FIG. 9  is the view of  FIG. 1  with the soft palate containing the implant of  FIG. 6 ;  
         [0020]      FIG. 10  is the view of  FIG. 2  showing three implants of the type of  FIG. 6  in the soft palate;  
         [0021]      FIG. 11  is a top, front and left side perspective view of a preferred embodiment of a combined handle and cartridge of the present invention shown in exploded form with the cartridge separated from the handle;  
         [0022]      FIG. 12  is a right side elevation view of the combined handle and cartridge of  FIG. 11  (with the opposite side being substantially identical);  
         [0023]      FIG. 13  is a top plan view of the combined handle and cartridge of  FIG. 11 ;  
         [0024]      FIG. 14  is a bottom plan view of the combined handle and cartridge of  FIG. 11 ;  
         [0025]      FIG. 15  is a rear end elevation view of the combined handle and cartridge of  FIG. 11 ;  
         [0026]      FIG. 16  is a front-end elevation view of the combined handle and cartridge of  FIG. 11 ;  
         [0027]      FIG. 17  is a side-sectional view of an assembled handle and cartridge of  FIG. 11  showing internal components;  
         [0028]      FIG. 18  is a top, front and side perspective view of a kit according to the present invention including a handle and a plurality of cartridges contained within a sterile container;  
         [0029]      FIG. 19  is a top and side perspective view of a kit according to the present invention including a plurality of cartridges contained within a sterile container;  
         [0030]      FIG. 20  is a view similar to that of  FIG. 11  showing an alternative embodiment of handle and cartridge (shown exploded in  FIG. 20 );  
         [0031]      FIG. 21  is a right side elevation view of the combined handle and cartridge of  FIG. 20 ;  
         [0032]      FIG. 22  is a left side elevation view of the combined handle and cartridge of  FIG. 20 ;  
         [0033]      FIG. 23  is a top plan view of the combined handle and cartridge of  FIG. 20 ;  
         [0034]      FIG. 24  is a bottom plan view of the combined handle and cartridge of  FIG. 20 ;  
         [0035]      FIG. 25  is a rear end elevation view of the combined handle and cartridge of  FIG. 20 ;  
         [0036]      FIG. 26  is a front end elevation view of the combined handle and cartridge of  FIG. 11 ; and  
         [0037]      FIG. 27  is a side-sectional view of an assembled handle and cartridge of  FIG. 20  showing internal components. 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0038]     With reference now to the various drawing figures, in which identical elements are numbered identically throughout, a detailed description of a preferred embodiment of the present invention will now be provided. The teachings of the following U.S. patents are incorporated herein by reference: U.S. Pat. No. 6,250,307 to Conrad et al. dated Jun. 26, 2001; U.S. Pat. No. 6,578,580 to Conrad et al. dated Jun. 17, 2003; U.S. Pat. No. 6,523,542 to Metzger et al. dated Feb. 25, 2003; U.S. Pat. No. 6,513,530 to Knudson et al. dated Feb. 4, 2003; and U.S. Pat. No. 6,431,174 to Knudson et al. dated Aug. 13, 2002.  
         [0039]     A. Physiology Background  
         [0040]      FIG. 1  shows, in cross-section, a naso-pharyngeal area of an untreated patient.  FIG. 2  shows a soft palate SP viewed through an open mouth of the untreated patient.  FIG. 1  shows the nose N, mouth M and throat TH. The tongue T is shown in an oral cavity OC of the mouth. A hard palate HP (containing a bone B) separates the oral cavity OC from the nasal cavity NC. The nasal concha C (soft tissue which defines, in part, the nasal sinus—not shown) resides in the nasal cavity NC.  
         [0041]     The soft palate SP (a muscle activated soft tissue not supported by bone) depends in cantilevered manner at a leading end LE from the hard palate HP and terminates at a trailing end TE. Below the soft palate SP, the pharyngeal wall PW defines the throat passage TP. A nasal passage NP connects the nasal cavity NC to the pharyngeal wall PW. Below an epiglottis EP, the throat passage TP divides into a trachea TR for passing air to the lungs and an esophagus ES for passing food and drink to the stomach.  
         [0042]     The soft palate SP is operated by muscles (not separately shown and labeled) to lift the soft palate SP to urge the trailing edge TE against the rear area of the pharyngeal wall PW. This seals the nasal cavity NC from the oral cavity OC during swallowing. The epiglottis EP closes the trachea TR during swallowing and drinking and opens for breathing.  
         [0043]     For purposes of this disclosure, the nasal cavity NC, oral cavity OC and throat passage TP are collectively referred to as the naso-pharyngeal area (or airway) of the patient with the area including the various body surfaces which cooperate to define the nasal cavity NC, oral cavity OC and throat passage TP. These body surfaces include outer surfaces of the nasal concha C, the upper and lower surfaces of the soft palate SP and outer surfaces of the pharyngeal wall PW. Outer surfaces means surfaces exposed to air. Both the upper and lower surfaces of the soft palate SP are outer surfaces.  
         [0044]     Snoring can result from vibration of any one of a number of surfaces or structures of the naso-pharyngeal area. Most commonly, snoring is attributable to vibration of the soft palate SP. However, vibratory action of the nasal concha C and the pharyngeal wall PW can also contribute to snoring sounds. It is not uncommon for vibratory action from more than one region of the naso-pharyngeal area to contribute to snoring sounds. Sleep apnea can result from partial or full collapse of the naso-pharyngeal wall during sleep as well as having nasal and palatal contributions.  
         [0045]     As indicated above, most of the present discussion will describe placing a stiffening implant in the soft palate SP, it will be appreciated the present invention is applicable to other regions of the naso-pharyngeal area including the nasal concha C and the pharyngeal wall PW. Also, it will be appreciated the present invention is applicable to airway conditions such as OSA or snoring and is not intended to be limited to snoring although this indication will be most frequently referenced for purpose of illustration of the invention. It will also be appreciated the present invention can be used with different types of implants (i.e., any of those referenced in the references incorporated by reference above) or any other implant which may be delivered from a needle.  
         [0046]     The snoring sound is generated by impulses caused by rapid obstruction and opening of airways. Huang, et al., state the airway passage opening and closing occurs 50 times per second during a snore. Huang, et al., utilize a spring-mass model ( FIG. 5 ) to illustrate oscillation of the soft palate in response to airflow (where the soft palate is the ball B of mass depending by a spring S from a fixed anchor A).  
         [0047]     A prior art technique for treating the soft palate is uvulopalatopharyngoplasty (UPPP). In UPPP, a trailing edge of the soft palate is removed. The shaded area SA in  FIG. 3  shows the area of the trailing end TE of the soft palate SP to be removed during this procedure. Huang, et al., analogize the shortening of the soft palate SP in UPPP as effectively raising the critical airflow speed at which soft palate flutter will occur. An alternative procedure proposed by Huang, et al., reduces the flexibility of the soft palate SP through surface scarring which is asserted as affecting the critical flow speed. The shaded area SA′ in  FIG. 4  shows the area to be scarred by this alternate procedure. In  FIG. 4 , dashed line L shows the demarcation between the soft and hard palates.  
         [0048]     Using the spring-mass model of  FIG. 5  as a convenient model of the soft palate SP, the present invention is directed to a delivery system for a surgical implant for the soft palate SP to alter the elements of the model and thereby alter the dynamic response of the soft palate SP to airflow.  
         [0049]     B. Disclosure of Commonly Assigned U.S. Patents  
         [0050]     The aforementioned commonly assigned US patents (which have been incorporated herein by reference) describe a wide variety of airway implants for treating snoring or OSA. These patents are U.S. Pat. Nos. 6,250,307; 6,578,580; 6,523,542; 6,513,530 and 6,431,174.  
         [0051]     In a presently preferred embodiment, the implant  20  is a braid of fibers  22 . While a single type fiber could be used in implant  20 , the implant can be formed of two or more different fibers braided or twisted together. For example, one fiber may be provided for encouraging fibrotic response. Such a fiber may be polyester or silk suture material. The other fiber may be a bio-resorbable fiber (e.g., bio-resorbable suture material which may include natural materials such as collagen or synthetic materials such as the PDS suture material). Alternatively, the other fiber may be a non-resorbable material such as polypropylene suture material to provide added stiffness to the implant.  
         [0052]     In a preferred embodiment (shown in  FIG. 6 ), the implant  20  is a composite braid of both air-textured and non-air-textured yarns of polyester formed in a braid of about 2 mm in diameter (D) and 18 mm in length (L′). Welds  24  are formed near the ends  26  of the implant  20  to bond the fibers  22 . The welds  24  are spaced from the ends  26  by a spacing S′ so that the fibers  22  in the spacing are free to fray and present a fluffier area for tissue in-growth. The implant  20  is fibrosis inducing to induce a fibrotic response of tissue following implantation. An implant having the foregoing characteristics is more fully described in the aforementioned U.S. Pat. No. 6,513,530.  
         [0053]      FIGS. 7 and 8  show a prior delivery tool  30  for placing the implant  20  in the soft palate SP.  FIGS. 9 and 10  illustrate the desired placement of the implant  20  in the soft palate SP. As shown in  FIG. 10 , three implants are preferably placed in the soft palate SP. One at the soft palate midline and one each on opposite sides of the midline about 5 mm from the midline.  
         [0054]     The delivery tool  30  includes a handle  32  and a needle  34  permanently secured to the handle  32 . The handle  32  is designed to be hand-grasped in a pistol-grip manner with a sliding thumb switch  36  positioned to oppose the operator&#39;s thumb (not shown) when the handle  32  is grasped. A removable tape  38  covers the thumb switch  36  during shipping and storage to prevent undesired movement of the thumb switch  36 . The distal tip  40  of the needle  34  is bent to permit ease of placement of the tip  40  in the soft palate SP without interference of the tool  30  with the patient&#39;s teeth or hard palate.  
         [0055]     The needle  34  is connected to the thumb switch  36  through linkage (not shown) contained within the handle  32  such that the needle retracts to the right (i.e., moves rearward into the handle  32 ) as the thumb switch is slid downwardly on the handle  32 . Directions “right”, “rearward” and “down” are with reference to the orientation shown in  FIG. 7 .  
         [0056]     The distal tip  40  of needle  34  has a bevel ground for piercing tissue of the soft palate. The needle  34  is hollow and carries the implant  20  in sliding close tolerance at the distal tip  40 .  
         [0057]     An obturator or rod  42  is positioned in the needle  34  between the implant  20  and the handle  32 . The obturator  42  is secured to the handle  32  so that is does not retract as the needle retracts. Therefore, as the needle  34  retracts, the needle  34  slides over the fixed-place obturator  42 . The distal end  43  of the obturator  42  butts against the implant  20 . This prevents the implant  20  from moving with the needle  34  as the needle  34  retracts. As a result, the retracting needle  34  exposes the implant  20 .  
         [0058]     The implant  20  is carried by the needle  34  to a desired implant site within the soft palate SP. At the desired site, the implant  20  is deployed by retracting the needle  34 . Retraction is performed by retracting back on thumb switch  36 . Retraction of the needle relative to the handle causes the obturator  42  to dispel the implant  20  from the needle  34 . The aforementioned U.S. Pat. No. 6,578,580 describes a retracting needle and stationary rod to deploy an implant in the soft palate. That patent also describes a pre-loaded implant.  
         [0059]     The needle has markings  44  to provide indication to an operator of depth of penetration of the needle tip  40  in tissue and location of the implant  20 . Corresponding markings  46  are placed on the handle  32  to illustrate the degree of needle retraction and implant exposure relative to sliding movement of the thumb switch  36 .  
         [0060]     The implant  20  is pre-loaded into the needle  34 . The needle  34  is non-removably secured to the handle  32  and all components are delivered in a sterile package. Such packaged implant and its delivery system are the subject of 510k clearance (K011723) from the U.S. Food and Drug Administration and CE Mark certification (CE 66447) from BSI Product Services indicated for use with the treatment of socially disruptive snoring. The product is sold by Restore Medical Inc., St. Paul, Minn., USA—assignee of the present application.  
         [0061]     C. Apparatus and Kit of the Present Invention  
         [0062]     With reference to  FIGS. 11-17 , the present invention is shown in a first preferred embodiment. The delivery system  100  of the present invention includes a cartridge  200  and a handle  300 . As will be more fully described, the cartridge  200  is separate from the handle  300  and may be attached to or detached from the handle  300  at the option of an operator.  
         [0063]     The cartridge  200  includes a hollow needle  202  and an implant  20 . Since, in a preferred embodiment, the implant  20  is identical to that shown in  FIG. 6  it is identically numbered in views of  FIG. 17 . As described above, the implant  20  is a braid of fibrosis-inducing fibers. The implant  20  may have a diameter slightly larger than the interior diameter of the needle such that the implant may expand upon ejection from the needle. As described in the aforementioned patents (e.g., U.S. Pat. No. 6,250,307), the implant  20  is adapted to alter a dynamic response of airway tissue following placement of the implant in the tissue.  
         [0064]     As will be more fully described, the cartridge  200  has a cartridge coupling  204  at the proximal end of the needle  202 . An obturator  206  is slidably disposed within the bore of the needle  202 . The implant  20  is placed at the distal tip  203  of the needle  202 . The obturator  206  is sized for a distal end of the obturator  206  to oppose and abut a proximal end of the implant  20 . The length of the obturator  206  is selected for a proximal end of the obturator  206  to be flush with a proximal end of the needle  202  at the cartridge coupling  204 .  
         [0065]     The handle  300  includes a driver mechanism  302 . The driver mechanism  302  includes a thumb switch  304  slidably mounted on the handle  300 . The thumb switch  304  moves forward from a lock position to a deploy position with the throw distance between the positions being greater than the length L′ of the implant  20 .  
         [0066]     The driver mechanism  302  also includes a push rod  306  contained within the handle  200 . The push rod  306  is connected to the thumb switch  304  to move with it as the switch  304  is moved between the lock and deploy positions.  
         [0067]     The handle  300  has a distal end  301  with a predetermined geometry. The cartridge coupling  204  has a mating geometry selected to couple with the predetermined geometry of the handle  300 . In the embodiment of  FIGS. 11 and 17 , the mating surfaces of the cartridge coupling  204  includes sidewalls  208  and top and bottom walls  210 . The sidewalls  208  are flexible and include an end barb  209  to releasable detach with indents on interior surfaces of the handle sidewalls  303 . The walls  208 ,  210  of the cartridge  200  align with the walls of the handle  300  so that the proximal end of the cartridge coupling  204  may be slid into mating engagement with the distal end  301  of the handle  300  with the barbs  209  releasably latching the cartridge  200  to the handle  300 .  
         [0068]     When positioned as described above, the cartridge  200  is coupled to the handle  300  with the proximal end of the obturator  206  exposed to and aligned with a distal end of the push rod  306 . The push rod  306  is aligned and sized with the needle bore to advance into the needle  202  and abut and push the obturator  206  when the cartridge coupling  204  is connected to the handle  300  and when the thumb switch  304  is moved forward. This action causes the obturator  206  to move forward toward the distal tip  203  of the needle  202 . Since the thumb switch throw is greater than the implant length (plus any spacing between the obturator  206  and implant  20  and between the obturator  206  and push rod  306 ), the complete throw of the switch  304  ejects the implant  20  from the distal tip  203 . When the thumb switch  304  is returned to the lock position, the push rod  306  is retracted from the needle  202  and the cartridge  200  may be removed from the handle  200  by squeezing sidewalls  208  inwardly to release the barbs  209  from the detents on sidewalls  303 .  
         [0069]     It will be noted that unlike the design of  FIG. 7 , the design of  FIGS. 11-17  moves the obturator  206  while holding the needle  202  fixed relative to the handle  300 . Similar to  FIG. 7 , both needle  202  and handle  300  have markings  244 ,  346 , respectively, to assist an operator in placement. The obturator  206  is part of the cartridge  200  and moves with the needle  202  when the cartridge  200  is disconnected from the handle  300 .  
         [0070]     In practice, a plurality of implants  20  are normally preferred to be placed in patient&#39;s tissue for each office visit.  FIG. 18  shows a kit including a handle  300  and three cartridges  200  contained within a package or container  400  (with clear cover  402 ) which (together with the handle  300  and cartridges  200 ) is sterilized. In  FIG. 18 , the cartridges  200  are all disconnected from the handle  300 . One of the cartridges  200  could be pre-connected to the handle  200  for convenience.  FIG. 19  shows an alternative kit where three cartridges  200  without a handle  300  are packed as a plurality of cartridges  200  in a single container  400 ′ (with clear cover  402 ′) with the container  400 ′ and cartridges  200  sterilized.  
         [0071]     In the embodiment of  FIGS. 11-17 , the cartridge  200  is coupled to the handle  300  by axially sliding the cartridge coupling  204  toward the distal end  303  of the handle.  FIGS. 20-27  illustrate an alternative embodiment where the coupling  204 ′ is moved sideways into the distal end  303 ′ of the handle  300 ′. Elements in common between the embodiments of  FIGS. 11-17  and  FIGS. 20-27  are numbered identically with the addition of an apostrophe to distinguish the embodiments and such elements need not be separately described. In  FIG. 20 , the distal tip  303 ′ of the handle has a side slot  320 ′ to receive the mating geometry of the cartridge coupling  204 ′. The handle  300 ′ includes a textured gripping surface including ribs  360 . In the depicted embodiments, the ribs  360  extend in a direction generally parallel to the direction of movement of the thumb switch  304 ′. The cartridge  200 ′ also includes gripping elements  362  provided on the top and bottom sides of the coupling  204 ′.  
         [0072]     The present invention has been described in a first preferred embodiment for delivery of a braided implant into tissue of the soft palate to treat an airway condition such as obstructive sleep apnea or socially disruptive snoring. It will be appreciated the present invention covers a wide variety of implants (e.g., instead of the braided implant, the implant may be a bolus of particulate material as described in U.S. Pat. No. 6,431,174 or a sheet of fibrosis-inducing material as described in U.S. Pat. No. 6,523,542). Also, the invention is readily adapted through change of needle size and curvature to permit placement of an implant in airway tissue other than the soft palate (e.g., placement in tissue of the nasal cavity or pharyngeal wall).