Patent Publication Number: US-11642123-B2

Title: Systems and methods for tissue suspension and compression

Description:
INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS 
     Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57. This application is a continuation application of U.S. application Ser. No. 16/128,816 filed Sep. 12, 2018, which is a continuation application of U.S. application Ser. No. 14/639,774 filed Mar. 5, 2015, which claims the priority benefit under 35 U.S.C. § 119(e) as a nonprovisional application of U.S. Provisional Application No. 61/948,473, filed on Mar. 5, 2014, which are hereby incorporated by reference in its entirety Also incorporated by reference in their entireties is U.S. Pat. No. 8,460,322 issued on Jun. 11, 2013, and U.S. Pat. Pub. No. 2014/0074518 A1 published on Mar. 13, 2014. 
    
    
     BACKGROUND 
     Field 
     In some aspects, the invention relates generally to suture passer systems and methods for tissue suspension and tissue compression. Disclosed herein are systems and methods for tissue suspension using one or more sutures, implants, fasteners and/or bone anchors for treating obstructive sleep apnea. 
     Description of the Related Art 
     In many surgical procedures, there is a need to pass a suture deep into tissue. Sometimes, a surgeon needs to pass a suture deep into tissue to suspend the tissue by fixing the suture to bone. In particular, one such surgical procedure is suspension of tissues for treating conditions such as obstructive sleep apnea (OSA). 
     Respiratory disorders during sleep are recognized as a common disorder with significant clinical consequences. During the various stages of sleep, the human body exhibits different patterns of brain and muscle activity. In particular, the REM sleep stage is associated with reduced or irregular ventilatory responses to chemical and mechanical stimuli and a significant degree of muscle inhibition. This muscle inhibition may lead to relaxation of certain muscle groups, including but not limited to muscles that maintain the patency of the upper airways, and create a risk of airway obstruction during sleep. Because muscle relaxation narrows the lumen of the airway, greater inspiratory effort may be required to overcome airway resistance. This increased inspiratory effort paradoxically increases the degree of airway resistance and obstruction through a Bernoulli effect on the flaccid pharyngeal walls during REM sleep. 
     Obstructive Sleep Apnea (OSA) is a sleep disorder that affects up to 2 to 4% of the population in the United States. OSA is characterized by an intermittent cessation of airflow in the presence of continued inspiratory effort. When these obstructive episodes occur, an affected person will transiently arouse, regain muscle tone and reopen the airway. Because these arousal episodes typically occur 10 to 60 times per night, sleep fragmentation occurs which produces excessive daytime sleepiness. Some patients with OSA experience over 100 transient arousal episodes per hour. 
     In addition to sleep disruption, OSA may also lead to cardiovascular and pulmonary disease. Apnea episodes of 60 seconds or more have been shown to decrease the partial pressure of oxygen in the lung alveoli by as much as 35 to 50 mm Hg. Some studies suggest that increased catecholamine release in the body due to the low oxygen saturation causes increases in systemic arterial blood pressure, which in turn causes left ventricular hypertrophy and eventually left heart failure. OSA is also associated with pulmonary hypertension, which can result in right heart failure. 
     Radiographic studies have shown that the site of obstruction in OSA is isolated generally to the supralaryngeal airway, but the particular site of obstruction varies with each person and multiple sites may be involved. A small percentage of patients with OSA have obstructions in the nasopharynx caused by deviated septums or enlarged turbinates. These obstructions may be treated with septoplasty or turbinate reduction procedures, respectively. More commonly, the oropharynx and the hypopharynx are implicated as sites of obstruction in OSA. Some studies have reported that the occlusion begins with the tongue falling back in an anterior-posterior direction (A-P) to contact with the soft palate and posterior pharyngeal wall, followed by further occlusion of the lower pharyngeal airway in the hypopharynx. This etiology is consistent with the physical findings associated with OSA, including a large base of tongue, a large soft palate, shallow palatal arch and a narrow mandibular arch. Other studies, however, have suggested that increased compliance of the lateral walls of the pharynx contributes to airway collapse. In the hypopharynx, radiographic studies have reported that hypopharyngeal collapse is frequently caused by lateral narrowing of the pharyngeal airway, rather than narrowing in the A-P direction. 
     OSA is generally diagnosed by performing overnight polysomnography in a sleep laboratory. Polysomnography typically includes electroencephalography to measure the stages of sleep, an electro-oculogram to measure rapid eye movements, monitoring of respiratory effort through intercostal electromyography or piezoelectric belts, electrocardiograms to monitor for arrhythmias, measurement of nasal and/or oral airflow and pulse oximetry to measure oxygen saturation of the blood. 
     Following the diagnosis of OSA, some patients are prescribed weight loss programs as part of their treatment plan, because of the association between obesity and OSA. Weight loss may reduce the frequency of apnea in some patients, but weight loss and other behavioral changes are difficult to achieve and maintain. Therefore, other modalities have also been used in the treatment of OSA, including pharmaceuticals, non-invasive devices and surgery. 
     Among the pharmaceutical treatments, respiratory stimulants and drugs that reduce REM sleep have been tried in OSA. Progesterone, theophylline and acetozolamide have been used as respiratory stimulants, but each drug is associated with significant side effects and their efficacy in OSA is not well studied. Protriptyline, a tricyclic antidepressant that reduces the amount of REM sleep, has been shown to decrease the frequency of apnea episodes in severe OSA, but is associated with anti-cholinergic side effects such as impotence, dry mouth, urinary retention and constipation. 
     Other modalities are directed at maintaining airway patency during sleep. Oral appliances aimed at changing the position of the soft palate, jaw or tongue are available, but patient discomfort and low compliance have limited their use. Continuous Positive Airway Pressure (CPAP) devices are often used as first-line treatments for OSA. These devices use a sealed mask which produce airflow at pressures of 5 to 15 cm of water and act to maintain positive air pressure within the pharyngeal airway and thereby maintain airway patency. Although CPAP is effective in treating OSA, patient compliance with these devices is low for several reasons. Sleeping with a sealed nasal mask is uncomfortable for patients. Smaller sealed nasal masks may be more comfortable to patients but are ineffective in patients who sleep with their mouths open, as the air pressure will enter the nasopharynx and then exit the oropharynx. CPAP also causes dry nasal passages and congestion. 
     Surgical treatments for OSA avoid issues with patient compliance and are useful for patients who fail conservative treatment. One surgery used for OSA is uvulopalatopharyngoplasty (UPPP). UPPP attempts to improve airway patency in the oropharynx by eliminating the structures that contact the tongue during sleep. This surgery involves removal of the uvula and a portion of the soft palate, along with the tonsils and portions of the tonsillar pillars. Although snoring is reduced in a majority of patients who undergo UPPP, the percentage of patients who experience reduced frequency of apnea episodes or improved oxygen saturation is substantially lower. Postoperatively, many patients that have undergone UPPP continue to exhibit oropharyngeal obstruction or concomitant hypopharyngeal obstruction. Nonresponders often have physical findings of a large base of tongue, an omega-shaped epiglottis and redundant aryepiglottic folds. UPPP is not a treatment directed at these structures. UPPP also exposes patients to the risks of general anesthesia and postoperative swelling of the airway that will require a tracheostomy. Excessive tissue removal may also cause velo-pharyngeal insufficiency where food and liquids enter into the nasopharynx during swallowing. 
     Laser-assisted uvulopalatopharyngoplasty (LAUP) is a similar procedure to UPPP that uses a CO 2  laser to remove the uvula and portions of the soft palate, but the tonsils and the lateral pharyngeal walls are not removed. 
     For patients who fail UPPP or LAUP, other surgical treatments are available but these surgeries entail significantly higher risks of morbidity and mortality. In genioglossal advancement with hyoid myotomy (GAHM), an antero-inferior portion of the mandible, which includes the attachment point of the tongue musculature, is repositioned forward and in theory will pull the tongue forward and increase airway diameter. The muscles attached to the inferior hyoid bone are severed to allow the hyoid bone to move superiorly and anteriorly. Repositioning of the hyoid bone expands the retrolingual airspace by advancing the epiglottis and tongue base anteriorly. The hyoid bone is held in its new position by attaching to the mandible using fascia. Variants of this procedure attach the hyoid bone inferiorly to the thyroid cartilage. 
     A laser midline glossectomy (LMG) has also been tried in some patients who have failed UPPP and who exhibit hypopharyngeal collapse on radiographic studies. In this surgery, a laser is used to resect the midline portion of the base of the tongue. This involves significant morbidity and has shown only limited effectiveness. 
     In some patients with craniofacial abnormalities that include a receding mandible, mandibular or maxillomandibular advancement surgeries may be indicated for treatment of OSA. These patients are predisposed to OSA because the posterior mandible position produces posterior tongue displacement that causes airway obstruction. In a mandibular advancement procedure, the mandible is cut bilaterally posterior to the last molar and advanced forward approximately 10 to 14 mm. Bone grafts are used to bridge the bone gap and the newly positioned mandible is wire fixated to the maxilla until healing occurs. Mandibular advancement may be combined with a Le Fort I maxillary osteotomy procedure to correct associated dental or facial abnormalities. These procedures have a high morbidity and are indicated only in refractory cases of OSA. 
     Experimental procedures described in the clinical literature for OSA include the volumetric radiofrequency tissue ablation and hyoidplasty, where the hyoid bone is cut into several segments and attached to a brace that widens the angle of the U-shaped hyoid bone. The latter procedure has been used in dogs to increase the pharyngeal airway lumen at the level of the hyoid bone. The canine hyoid bone, however, is unlike a human hyoid bone because the canine hyoid bone comprises nine separate and jointed bones, while the human hyoid bone comprises five bones that are typically fused together. 
     Another surgical procedure performed to treat OSA is suture based tongue suspension. However, current techniques for suture based tongue suspension require the passage of suture through the tongue and into the oral space. This technique carries with it significant risks of infection as well as difficulty in accessing the optimal placement for the suspension suture. 
     Notwithstanding the foregoing, there remains a need for improved methods and devices for treating various conditions, including but not limited to obstructive sleep apnea. There is also a need for improved devices and methods for delivering suture into tissue. Specifically with respect to current methods for tissue suspension and compression, there is a need to reduce infection risk due to suture exposure to the oral cavity, to improve the surgeon&#39;s range and ability to precisely locate and orient the suture, and to improve the ability of surgeons to properly tension the suture by eliminating the need to perform knot-tying while simultaneously controlling the final tension of the suture. 
     SUMMARY 
     The present disclosure provides suture passer system and methods for tissue suspension or compression. 
     In some embodiments, a suture passer is provided. The suture passer can comprise a proximal handle. The suture passer can comprise an elongate shaft having a proximal end, a distal end, and a longitudinal axis. The suture passer can comprise a suture passing element coupled to the distal end of the shaft. In some embodiments, the suture passing element is movable with respect to the shaft, and configured to swivel with respect to the shaft in an arc of at least about 90 degrees. In some embodiments, the suture passing element comprises a feature to engage the suture. In some embodiments, the suture passing element comprises a tube. 
     In some embodiments, a suture passer is provided. The suture passer can comprise an elongate shaft. The suture passer can comprise a suture passing element coupled to the elongate shaft. In some embodiments, the suture passing element is configured to swivel with respect to the elongate shaft. The suture passer can comprise a second stage element carried within the suture passing element. In some embodiments, the second stage element can be configured to extend from and retract into the suture passing element. In some embodiments, the second stage element can be configured to exit an opening at or near a distal end of the suture passing element and form a path through tissue. The suture passer can comprise a suture carried by the second stage element. In some embodiments, the second stage element comprises a grasping element operably connected to the suture. In some embodiments, the grasping element comprises a snare. In some embodiments, the grasping element comprises movable jaws. 
     In some embodiments, a suspension line is provided. The suspension line can comprise a suture. The suspension line can comprise an overmolded segment. The suspension line can comprise a feature between the suture and the overmolded segment which serves as a bearing. 
     In some embodiments, a method is provided. The method can include the step of providing an implant having a first end and a second end. The method can include the step of securing the first end of the implant to the palatopharyngeal arch. The method can include the step of tensioning the implant. The method can include the step of securing the second end of the implant to a tissue selected from the group consisting of: the superior pharyngeal constrictor muscle, palatopharyngeal arch, and palatoglossal arch. 
     In some embodiments, the implant comprises barbs. In some embodiments, the implant comprises suture loops. The method can include the step of securing the implant to a bone anchor. The method can include the step of adjusting the tension of the implant post-operatively. 
     In some embodiments, a method is provided. The method can include the step of moving a portion of a tissue selected from the group consisting of: the superior pharyngeal constrictor muscle, palatopharyngeal arch, and palatoglossal arch. The method can include the step of securing a fastener to a tissue selected from the group consisting of: the superior pharyngeal constrictor muscle, palatopharyngeal arch, and palatoglossal arch. 
     In some embodiments, a method is provided. The method can include the step of forming a loop around the hyoid bone. The method can include the step of securing the loop to a bone anchor, wherein the bone anchor is located on the mandible. In some embodiments, the loop is a girth hitch. In some embodiments, the loop is formed by an implant comprising a longitudinally extending tail and an implant head. In some embodiments, the implant comprises a ratchet for tensioning the loop. 
     In some embodiments, a method is provided. The method can include the step of forming a hole in the hyoid bone. The method can include the step of passing an implant through the hole in a collapsed configuration. The method can include the step of expanding the implant to an expanded configuration, wherein the implant is unable to pass through the hole in the expanded configuration. In some embodiments, the implant comprises expandable barbs. 
     In some embodiments, a suspension line for tensioning tissue is provided. The suspension line can comprise a suture having a first thickness dimension. The suspension line can comprise an elastomer surrounding a portion of the suture having a second thickness dimension greater than the first thickness dimension. The suspension line can comprise at least one bearing element configured to allow the suture to move with respect to the elastomer while maintaining the flexibility of the suture. 
     In some embodiments, the at least one bearing element is at least partially covered by the elastomer. In some embodiments, the at least one bearing element comprises a knot. In some embodiments, the at least one bearing element comprises a bead. In some embodiments, the at least one bearing element comprises a coil. In some embodiments, the coil comprises polypropylene. In some embodiments, the elastomer comprises silicone. In some embodiments, the elastomer is at least partially radiopaque. In some embodiments, the elastomer is compounded with a radiopacifier. 
     In some embodiments, a suture passer is provided. The suture passer can comprise a first section with a first distal tip and a first proximal handle. The suture passer can comprise a second section with a second distal tip and a second proximal handle. The suture passer can comprise a slot on the sidewall of the first section. The suture passer can comprise a first interior lumen extending through a portion of the first section and in communication with the slot. The suture passer can comprise a plunger configured to enter the slot and the first interior lumen and move a suture toward the second section. 
     In some embodiments, the plunger comprises a feature to engage the suture. The suture passer can comprise a second interior lumen extending through a portion of the second section. In some embodiments, the plunger is configured to enter the second interior lumen. In some embodiments, the second section comprises a snare. In some embodiments, the first section is configured to pivot relative to the second section. In some embodiments, the plunger comprises a head, wherein the head has at least one dimension larger than a corresponding dimension of the plunger. In some embodiments, the first distal tip is curved. In some embodiments, the second distal tip is curved. In some embodiments, the first interior lumen is open at the first distal tip. In some embodiments, the second interior lumen is open at the second distal tip. 
     In some embodiments, a method of using a suture passer is provided. The method can include the step of providing a suture passer comprising a first section with a first distal tip, a second section with a first distal tip, and a first interior lumen extending through a portion of the first section. The method can include the step of advancing the suture passer around a hyoid bone. The method can include the step of passing a plunger into the first interior lumen. 
     The method can include the step of engaging the plunger with a suture. The method can include the step of engaging the suture with a snare. The method can include the step of engaging the suture with a feature of the second section. The method can include the step of disengaging the suture as the plunger is retracted through the first interior lumen. The method can include the step of protruding the plunger from the first interior lumen toward the second distal tip. In some embodiments, the suture passer comprises a second interior lumen extending through a portion of the second section, further comprising passing the plunger into the second interior lumen. The method can include the step of engaging the suture with a snare coupled to the second section. The method can include the step of engaging the suture with a feature coupled to the second section. The method can include the step of engaging a suture with the second section. The method can include the step of advancing the plunger toward the suture. The method can include the step of engaging the suture with the plunger. The method can include the step of moving the suture through the first interior lumen as the plunger is retracted. The method can include the step of moving the suture through the first interior lumen as the first section is pivoted. 
     In some embodiments, a method is provided. The method can include the step of providing a suture having a first strand, a second strand, and an arc between the first strand and the second strand. The method can include the step of placing the arc on one side of the hyoid bone. The method can include the step of placing the first strand and the second strand on the other side of the hyoid bone. The method can include the step of forming a girth hitch around the hyoid bone. The method can include the step of securing the first strand and the second strand to a bone anchor. In some embodiments, the bone anchor is located on the mandible. In some embodiment, the system further includes a second suture comprising a third strand, a fourth strand, and a second arc between the third strand and the fourth strand. The method can include the step of coupling the third strand to the first strand. The method can include the step of pulling the third strand to form the girth hitch. The method can include the step of placing the second arc under the first arc. The method can include the step of pulling the suture such that the second arc is on one side of the hyoid bone and both the third and fourth strands are on other side of the hyoid bone. In some embodiments, the system further comprises an elastomer surrounding a portion of the suture. In some embodiments, the system further comprises an at least one bearing element on the suture. In some embodiments, the at least one bearing element is at least partially covered by the elastomer. 
     In some embodiments, an apparatus is provided having a shaft for passing a suture and a needle coupled to the shaft. The needle is freely rotatable with respect to the shaft. The needle can include a feature to engage the suture. The needle can include a tube. The apparatus can have a second stage element configured to extend from the needle. 
     In some embodiments, an apparatus is provided having a suture, an overmolded segment, and a feature between the suture and the overmolded segment which serves as a bearing. 
     In some embodiments, a method is provided which comprises the steps of providing an implant having a first end and a second end, securing the first end of the implant to the palatopharyngeal arch, tensioning the implant, and securing the second end of the implant to a tissue selected from the group consisting of: the superior pharyngeal constrictor muscle, palatopharyngeal arch, and palatoglossal arch. The implant can include barbs. The implant can include suture loops. The method can include the step of securing the implant with a bone anchor. The method can include the step of adjusting the tension of the suture loops post-operatively. 
     In some embodiments, a method is provided which comprises the steps of moving a portion of a tissue selected from the group consisting of: the superior pharyngeal constrictor muscle, palatopharyngeal arch, and palatoglossal arch; and securing a fastener to a tissue selected from the group consisting of: the superior pharyngeal constrictor muscle, palatopharyngeal arch, and palatoglossal arch. 
     In some embodiments, a method is provided which comprises the steps forming a loop around the hyoid bone, and securing the loop to a bone anchor, wherein the bone anchor is located on the mandible. The loop can be a girth hitch. The loop can be formed by an implant comprising a longitudinally extending tail and an implant head. The implant can include a ratchet. 
     In some embodiments, a method is provided which comprises the steps of forming a hole the hyoid bone; passing an implant through the hole in a collapsed configuration; and expanding the implant to an expanded configuration, wherein the implant is unable to pass through the hole. The implant can include expandable barbs. 
     Also disclosed herein is a suture passer comprising one or more of: a proximal handle; an elongate shaft having a proximal end, a distal end, a tubular body, and a longitudinal axis; a needle coupled to the distal end of the shaft, the needle having an arcuate deployed configuration, wherein the needle is movable with respect to the shaft, and configured to swivel with respect to the shaft in an arc of at least about 90 degrees; and a control on the proximal handle configured to swivel the needle with respect to the shaft. The needle can comprise a feature to engage the suture, and comprise a tube in some embodiments. 
     In some embodiments, disclosed herein is a suture passer comprising one or more of: a proximal handle having a first actuator control and a second actuator control; a first elongate shaft extending distally from the handle; a first needle carried within the first elongate shaft, the first needle configured to extend from and retract into the first elongate shaft, the first needle having a straight configuration when located within the first elongate shaft, the first needle configured to exit an opening at or near a distal end of the first elongate shaft and form a curved or lateral path through tissue upon actuation of the first actuator control; and a second needle carried within the first needle, the second needle configured to extend from and retract into the first needle, the second needle having a straight configuration when located within the first elongate shaft, the first needle configured to exit an opening at or near a distal end of the first needle and form a curved or lateral path through tissue upon actuation of the second actuator control, the second needle having an extended geometry that is different from that of the first needle; and a suture carried by the second needle. The second needle can comprise a grasping element operably connected to the second needle, such as, for example, a snare or movable jaws. 
     Also disclosed herein is a suspension line comprising a suture; an overmolded segment; and a feature between the suture and the overmolded segment which serves as a bearing. 
     In another embodiment, disclosed is a method comprising providing an implant having a first end and a second end; securing the first end of the implant to the palatopharyngeal arch; tensioning the implant; and securing the second end of the implant to a tissue selected from the group consisting of: the superior pharyngeal constrictor muscle, palatopharyngeal arch, and palatoglossal arch. The implant can comprises barbs and/or suture loops. The implant can also be secured with a bone anchor. The tension of the suture loops can be adjusted during the procedure, or post-operatively, such as 1 hour, 6 hours, 1 day, 1 week, 1 month, or more post-operatively. 
     Also disclosed is a method comprising moving a portion of a tissue selected from the group consisting of: the superior pharyngeal constrictor muscle, palatopharyngeal arch, and palatoglossal arch; and securing a fastener to a tissue selected from the group consisting of: the superior pharyngeal constrictor muscle, palatopharyngeal arch, and palatoglossal arch. 
     Also disclosed is a method comprising: forming a loop around the hyoid bone; and securing the loop to a bone anchor, wherein the bone anchor is located on the mandible. The loop can be a girth hitch. The loop can be formed by an implant comprising a longitudinally extending tail and an implant head. The implant can also comprise a ratchet for tensioning the loop. 
     In some embodiments, disclosed is a method comprising: forming a hole in the hyoid bone; passing an implant through the hole in a collapsed configuration; and expanding the implant to an expanded configuration, wherein the implant is unable to pass through the hole. The implant can comprise expandable barbs. 
     Further disclosed herein is a suspension line for tensioning tissue, comprising: a suture having a first thickness dimension; a elastomer surrounding a portion of the suture and defining a central segment of the suspension line having a second thickness dimension greater than the first thickness dimension; and at least one bearing element on the central segment of the suspension line, the bearing element configured to provide a rigid bearing to allow the suture to move with respect to the elastomer (e.g., silicone) while maintaining the flexibility of the suture. The at least one bearing element can be at least partially covered by the elastomer. The bearing element can include, for example, a knot, a bead, and/or a coil. The coil can comprise polypropylene, for example. The elastomer can be at least partially radiopaque, and/or compounded with a radiopacifier, such as barium sulfate for example. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS.  1 A- 1 C  illustrate an embodiment of a suture passer with a suture passing element. 
         FIGS.  2 A- 2 C  illustrate a method of using the suture passer of  FIG.  1 A . 
         FIGS.  3 A- 3 D  illustrate an embodiment of a suture passer with a suture passing element. 
         FIGS.  4 A- 4 D  illustrate embodiments of a suture passing element. 
         FIG.  5    illustrates the inability of a suture passer to reach a target location. 
         FIGS.  6 A- 6 C  illustrate an embodiment of a suture passer with a second stage element. 
         FIGS.  7 A- 7 B  illustrate an embodiment of a suture passer with a second stage element. 
         FIGS.  8 A- 8 B  illustrate an embodiment of a suture passer with a second stage element. 
         FIGS.  9 A- 9 B  illustrate an embodiment of a suture passer system with a second stage element. 
         FIGS.  10 A- 10 B  illustrates an embodiment of a suture passer with a second stage element. 
         FIGS.  11 A- 11 E  illustrate embodiments of a suture. 
         FIGS.  12 A- 12 B  illustrate a method of making a suture. 
         FIGS.  13 A-D  illustrates a method of delivering a plurality of suture loops into tissue. 
         FIG.  14    illustrates a method of narrowing the lateral pharyngeal wall, according to one embodiment of the invention. 
         FIGS.  15 A- 15 B  illustrate the anatomy with and without an implant. 
         FIGS.  16 A- 16 D  illustrate an embodiment of a method of inserting an implant. 
         FIGS.  17 A- 17 B  illustrate an embodiment of an implant with a tissue ingrowth portion. 
         FIGS.  18 A- 18 B  illustrate an embodiment of a method of inserting an implant. 
         FIGS.  19 A- 19 E  illustrate an embodiment of a method of inserting a suture. 
         FIG.  20    illustrates an embodiment of a method of inserting a suture. 
         FIGS.  21 A- 21 B  illustrate an embodiment of a method of using a bone anchor. 
         FIGS.  22 A- 22 B  illustrate an embodiment of an apparatus and method of securing a tissue. 
         FIGS.  23 A- 23 C  illustrate embodiments of a fastener. 
         FIGS.  24 A- 24 D  illustrate an embodiment of a method of hyoid bone suspension. 
         FIGS.  25 A- 25 B  illustrate an embodiment of a suture passer. 
         FIGS.  26 A- 26 B  illustrate an embodiment of a method of hyoid bone suspension. 
         FIGS.  27 A- 27 D  illustrate an embodiment of a method of hyoid bone suspension. 
         FIG.  28    illustrates an embodiment of a method of hyoid bone suspension. 
         FIGS.  29 A- 29 C  illustrate an embodiment of an implant and a method of hyoid bone suspension. 
         FIG.  30    illustrates an embodiment of an implant. 
         FIG.  31    illustrates a method of hyoid bone suspension using an implant. 
         FIGS.  32 A- 32 B  illustrate an embodiment of an implant. 
         FIGS.  33 A- 33 B  illustrate an embodiment of an implant. 
         FIGS.  34 A- 34 F  illustrate an embodiment of a suture passer. 
     
    
    
     DETAILED DESCRIPTION 
     In some embodiment, disclosed is a suture passer system and method for passing a suture (e.g., a suspension line, a tether, a tether loop, a suture, a suture loop, suture tape, an implant, etc.) through tissue to suspend or compress the tissue. The term “suture” as used herein, unless otherwise specified or limited, is intended to have its ordinary meaning and is also intended to include all structures, including any of the aforementioned or later-described examples, that can be passed through tissue using the devices described herein. 
     As illustrated in  FIG.  1 A , the suture passer  100  can include a first elongate tubular body or shaft  102 . The shaft  102  can releasably couple to a suture passing element  104 . The suture passing element  104  can be a flexible needle. The suture passing element  104  can pass one, two, or more sutures therethrough. Portions of the one or more sutures can reside outside of the first shaft  102 . The distal end of the suture passing element  104  can be sharpened to facilitate tissue penetration. In other embodiments, the distal end of the suture passing element  104  can be blunt to prevent distal penetration through the mucosa, thus preventing a through-and-through puncture. The shaft  102  can have a length of between about 4 cm to about 30 cm in some embodiments. 
     The suture passer  100  can include a second elongate tubular body or shaft (not shown). The second shaft can couple to a suture receiving element (not shown). The suture receiving element can be a snare, for example. The second shaft and the suture passer  100  can be substantially similar to suture passer system described in commonly owned U.S. Pat. No. 8,460,322, the entire disclosure of which is incorporated by reference. The suture passer  100  can include any feature described in in commonly owned U.S. Pat. No. 8,460,322. 
     The shaft  102  can extend distally from a proximal handle  108 . As illustrated in  FIG.  1 A , the proximal end of the shaft  102  can be coupled to the handle  108 . In some embodiments, the shaft  102  rotates when the handle  108  rotates. The shaft  102  can rotate about the longitudinal axis  114  of the proximal handle  108 . In some embodiments, the shaft  102  can rotate independently from the handle  108 . The shaft  102  can rotate about the longitudinal axis  112  of the shaft  102 . 
     As illustrated in  FIG.  1 A , the suture passing element  104  can be coupled to the distal end of the shaft  102 . The suture passing element  104  can rotate relative to the distal end of the shaft  102 . The shaft  102  can include one, two, or more slots or apertures  105  on the sidewall of the distal end of the shaft  102 . The suture passing element  104  can be located within the slot  105 . In some embodiments, the suture passing element  104  is formed as an independent component from the shaft  102 . The suture passing element  104  can rotate relative to the slot  105  (e.g., 0°, 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 150°, 160°, 170°, 180°, 190°, 200°, 210°, 220°, 230°, 240°, 250°, 260°, 270°, 280°, 290°, 300°, 310°, 320°, 330°, 340°, 350°, 360°, at least 90°, at least 180°, at least 270°, etc., or a range including any two of the foregoing values, such as between about 0° and about 180° for example). 
     The suture passing element  104  can function as a hook. The suture passing element  104  can be moved in position relative to the shaft  102 . The shaft  102  can be rotated relative to the suture passing element  104  after the suture passing element  104  hooks, or passes an elongate element around a bone. The suture passing element  104  can rotate when the shaft  102  is held stationary. The shaft  102  can rotate when the suture passing element  104  is held stationary. The suture passing element  104  and the shaft  102  can rotate at the same time, in the same directions and/or orientations or a different directions and/or orientations. The suture passing element  104  can rotate relative to the longitudinal axis  112  of the shaft  102 . The suture passing element  104  can rotate relative to the longitudinal axis  114  of the proximal handle  108 . The suture passing element  104  can rotate about an axis  116 , wherein axis  116  is perpendicular to the longitudinal axis  112  of the shaft  102 . The suture passing element  104  can rotate about one, two, or more axes. In some embodiments, the suture passing element  104  while rotating in an arc, offset from the longitudinal axis of the shaft  102 , during at least one point during rotation the path of the arc intersects the longitudinal axis  112  of the shaft  102 . The degree of rotation of the suture passing element  104  can be, in some embodiments, at least about 45°, 90°, 135°, 180°, 225° or more, or between about 90° and 180°, 135-225°, or different ranges including two of the foregoing values thereof for example. 
     The suture passing element  104  can include a longitudinal axis  118 . In some orientations, the longitudinal axis  118  of the suture passing element  104  is aligned with the longitudinal axis  112  of the shaft  102 , as shown in  FIGS.  1 A and  2 A . In some orientations, the longitudinal axis  118  of the suture passing element  104  is not aligned with the longitudinal axis  112  of the shaft  102 , as shown in  FIGS.  1 B,  1 C, and  2 C  as well as the schematic of  FIG.  1 C  clarifying certain features. The suture passing element  104  can be rotated relative to the slot  105  as shown in  FIG.  1 C . 
     In some embodiments, a mechanism (not shown) can control the rotation of the suture passing element  104  relative to the shaft  102 . The mechanism  110  can be housed within the shaft  102 . The suture passing element  104  can be coupled to the shaft  102 . The suture passing element  104  can be retained in the slot  105 . The slot  105  can include a bushing  120  or other device known in the art to permit free rotation. The distal end of the shaft  102  can be split to house the bushing  120 . A component  130  such as a fastener can couple the split distal end of the shaft  102  to prevent the disengagement and/or loosening of the bushing  120 . In some embodiments, the bushing  120  provides friction to hold the suture passing element  104  relative to the shaft  102 . The torque exerted by rotating the shaft  102  can rotate the shaft  102  relative to the suture passing element  104 . 
     As illustrated in  FIGS.  2 A- 2 C , a method of using the suture passer  100  is shown with respect to the hyoid bone. The method illustrates a generally superior to inferior approach. The longitudinal axis  118  of the suture passing element  104  can be generally aligned with the longitudinal axis  112  of the shaft  102 . The suture passing element  104  can extend from the distal end of the shaft  102 . The shaft  102  can be manipulated relative to the hyoid bone until the suture passing element  104  surrounds, such as least partially circumscribes a portion of the hyoid bone.  FIG.  2 B  illustrates the front view of the approach. As shown in  FIGS.  2 A- 2 B , the longitudinal axis  118  of the suture passing element  104  is aligned with the longitudinal axis  112  of the shaft  102 . The suture passing element  104  can hook or otherwise pass an elongate element such as a suture around the hyoid bone. The shaft  102  can be rotated relative to the suture passing element  104  and/or the suture passing element  104  can be rotated relative to the shaft.  FIG.  2 C  illustrates the suture passing element  104  in a position after a completed pass in some embodiments. The shaft  102  is rotated relative to the suture passing element  104  a different position relative to the hyoid bone. The longitudinal axis  118  of the suture passing element  104  is not aligned with the longitudinal axis  112  of the shaft  102 . 
     As illustrated in  FIGS.  3 A- 3 D , the suture passing element  104  can rotate relative to the shaft  102 . This can be completed by an internal mechanism to actively rotate the suture passing element  104 , overcoming frictional forces between the shaft  102  and the suture passing element  104 . The suture passing element  104  can be coupled to the shaft  102  via the bushing  120 . The suture passing element  104  can rotate in an arc about, or at least about 15 degrees, 30 degrees, 60 degrees, 90 degrees, 105 degrees, 120 degrees, 135 degrees, 150 degrees, 165 degrees, 180 degrees, 195 degrees, 210 degrees, 225 degrees or more relative to the axis  116 . The axis  116  can be transverse to the longitudinal axis  112  of the shaft  102 . 
     The suture  106  can be carried by the suture passing element  104  and thereby passed around the hyoid bone. As illustrated in  FIG.  4 A , the suture  106  can form a suture loop including a first strand  106 A, a second strand  106 B and an arc (e.g., loop portion)  106 C connected to and residing between the first strand  106 A and the second strand  106 B. The arc  106 C can form a portion of a circle. The suture  106  can be pre-attached to the suture passing element  104  prior to the suture passing element  104  being passed around the hyoid bone. In other embodiments, the suture  106  can be attached to the suture passing element  104  after the suture passing element  104  is passed around the hyoid bone. The suture  106  can be passed around the hyoid bone as the suture passer  100  is retracted. The suture  106  can remain in place, around the hyoid bone, after the suture passer  100  is retracted. 
     As illustrated in  FIGS.  4 A- 4 D , the suture passing element  104  can have a variety of configurations. As shown in  FIGS.  4 A- 4 C , a portion of the suture passing element  104  can include one or more suture engagement mechanisms. As shown in  FIG.  4 A , the suture engagement mechanism can be a slot  124 . The suture  106  can be inserted into the slot  124 . For instance, the first strand  106 A, the second strand  106 , and/or the arc  106 C can be inserted into the slot. The insertion of the arc  106 C into the slot  124  and around the hyoid bone may facilitate the tying of a knot, as described herein. As shown, the slot  124  can be a lateral slot extending through the suture passing element  104 . The suture  106  can be inserted so that the arc  106 C is on one side of the suture passing element  104  and the first strand  106 A and the second strand  106 B of the suture  106  are on the other side of the suture passing element  104 . 
     As shown in  FIG.  4 B , the suture engagement mechanism can be a plurality of holes  126 ,  126 ′ (e.g., two or more holes). While two holes are shown, other configurations are contemplated (e.g., three, four, five, six, etc.). The first strand  106 A of the suture  106  can be inserted into a first hole  126 , and the second strand  106 B of the suture  106  can be inserted into a second hole  126 ′. As shown, the holes  126 ,  126 ′ can be laterally-facing (or alternatively distal-facing) holes with respect to the distal end of the suture passing element  104 . The holes  126 ,  126 ′ can extend through the suture passing element  104 . The suture  106  can be inserted so that the arc  106 C is on one side of the suture passing element  104  and the first strand  106 A and the second strand  106 B of the suture  106  are on the other side of the suture passing element  104 . 
     As shown in  FIG.  4 C , the suture engagement mechanism can be a notch  128 . The suture  106  can be inserted into the notch  128 . As shown, the notch  128  can be a lateral notch extending along a surface of the suture passing element  104 . The arc  106 C of the suture  106  can be inserted into the notch  128 . The first strand  106 A is on one side of the suture passing element  104  and the second strand  106 B is on the other side of the suture passing element  104 . The slot  124 , the holes  126 , and the notch  128  can be formed in a distal end of the suture passing element  104 . The suture  106  can be coupled to the suture passing element  104  before or after passing the suture passing element  104  is passed around a bone or tissue. In some methods, the suture engagement mechanism can guide the suture  106  around the bone or tissue. 
     As shown in  FIG.  4 D , the suture engagement mechanism can be a lumen  130 . In some embodiments, the lumen  130  extends through a portion of the entire length of the suture passing element  104 . The lumen  130  can include a distally-facing exit aperture, as opposed to the laterally-facing suture engagement mechanisms described with respect to  FIGS.  4 A- 4 C . The lumen  130  can extend the entire length of the suture passing element  104 . The lumen  130  can extend along the length of the curved longitudinal axis  118  of the suture passing element  104 . In other words, the suture passing element  104  can be in the form of a tubular structure. 
     In some embodiments, the suture passing element  104  includes a second stage element  132  as shown in  FIG.  6 A . The second stage element  132  can be movable within the central lumen  130  as illustrated in  FIG.  4 D . The second stage element  132  can be coaxial with the suture passing element  104 . The suture passing element  104  allows for the passage of the second stage element  132  through the suture passing element  104 . As shown in  FIG.  5   , the suture passing element  104  may be unable to reach a target location  302 . The suture passing element  104 , in some embodiments, does not penetrate the soft tissue  300 . In some cases, this limitation is caused by the interference of the shaft  102  with the soft tissue  300 . In some cases, this limitation is caused by the geometry of the suture passer  100  and/or the geometry of the patient&#39;s anatomy. 
     This limitation has been observed, for example, in some cases when attempting to pass the suture passing element  104  close to the backside (e.g., posterior surface) of a body structure such as a bone  200 , such as the hyoid bone for example. The bone  200  can be located deep within an incision. The bone  200  can be surrounded by soft tissue  300 . A suture passing element  104  that is agile enough to start the pass while maintaining proximity to the bone  200  may not be sufficiently long enough to penetrate the soft tissue on the opposing side of the bone  200  to reach the target location  302 . In other words, the need for agility of the suture passing element  104  may limit the length of the suture passing element  104 . In other words, the design constraints of the suture passer  100  may prevent the suture passing element  104  from reaching the target location  302 . 
     The second stage element  132  can be deployed to reach the target location  302 , as shown in  FIG.  6 A . The second stage element  132  can be deployed through the lumen  130  of the suture passing element  104 . The suture passer  100  with the second stage element  132  can penetrate the soft tissue  300  after passing around the bone  200 . The suture passer  100  with the second stage element  132  can form a complete pass (e.g., a loop) around the bone  200 . 
     As shown in  FIGS.  6 A- 6 B , the second stage element  132  can extend distally beyond, and from a distal end of the suture passing element  104 . The second stage element  132  can be a linear extension of the distal end of the suture passing element  104 . As shown in  FIGS.  6 A- 6 C , a tool  134  can be used to pass the second stage element  132  through the suture passing element  104 . The tool  134  can insert the second stage element  132  into the lumen  130  of the suture passing element  104 . In some embodiments, the second stage element  132  can be inserted into the suture passing element  104  at the proximal end of the suture passing element  104 . In some embodiments, the second stage element  132  can be inserted into the suture passing element  104  at the location where the suture passing element  104  couples with the shaft  102 . 
     The second stage element  132  can include a needle  136 , as shown in  FIG.  6 B . The needle  136  facilitates the additional tissue penetration to reach the target location  302 . The second stage element  132  can include a suture engagement mechanism to engage suture  106 . The suture engagement mechanisms can include those shown in  FIGS.  4 A- 4 D . For instance, the distal end of the second stage element  132  can include a slot, one or more holes, a notch, or a lumen or other feature. 
     As shown in  FIGS.  7 A- 7 B , the second stage element  132  can include a snare  137 . The snare  137  can extend through the lumen  130  of the suture passing element  104  as described herein.  FIG.  7 A  shows the snare  137  retracted and  FIG.  7 B  shows the snare  137  advanced from the distal end of the suture passing element  104 . The snare  137  creates a larger target for the user to place the suture  106 . In other words, the snare  137  may be, in some embodiments, easier to thread with the suture  106  than the suture engagement mechanisms such as the slot, the holes, and the notch, shown in  FIGS.  4 A- 4 D . 
     As shown in  FIGS.  8 A- 8 B , the second stage element  132  can include features of  FIGS.  6 A- 6 B and  7 A- 7 B . The second stage element  132  can include both a needle  140  and a snare  142 . The needle  140  facilitates the additional tissue penetration to reach the target location  302 . The snare  142  creates a larger target for the user to place the suture  106  in the suture passer  100 . The snare  142  can be operably attached to the needle  140  as illustrated, such as via laterally-facing apertures in the needle  140 .  FIG.  8 A  shows the second stage element  132  in a retracted configuration and  FIG.  8 B  shows the second stage element  132  in an extended configuration and advanced from the distal end of the suture passing element  104 . 
     As shown in  FIGS.  9 A- 9 B , the second stage element  132  can be a grasper  144  having a plurality of movable jaws. The grasper  144  can be configured to hold one or more sutures  106  when the grasper  144  is retracted.  FIG.  9 A  shows the grasper  144  retracted.  FIG.  9 B  shows the grasper  144  advanced from the distal end of the suture passing element  104 . In some embodiments, the grasper  144  can open when deployed from the distal end of the suture passing element  104 , releasing the sutures  106 . The sutures  106  can be coupled to the grasper  144  and/or the suture passer  100  prior to the suture passer  100  advancing around the bone  200 . In some embodiments, the grasper  144  can close around the sutures  106  and transport the sutures  106  around the bone  200 . The grasper  144  can be retracted into the suture passing element  104 . 
     In some embodiments, the suture passing element  104  can have a complex configuration having a plurality of distal curved regions having differing radii of curvature, such as a first region having a first radii of curvature, and a second region having a second radii of curvature that is greater or less than the first radii of curvature. The first region and the second region can have convex curves, concave curves, or one convex and the other concave in some embodiments.  FIGS.  10 A- 10 B  show a coiled suture passing element  148 , resembling a pig&#39;s tail. The coiled suture passing element  148  can have any combination of the characteristics described herein with reference to suture passing element  104 . The coiled suture passing element  148  can be tubular. The coiled suture passing element  148  can include a second stage element  132 . The second stage element  132 , such as a needle, facilitates the additional tissue penetration to reach the target location  302 . The second stage element  132 , such as a snare, can create a larger target for the user to place the suture  106 . The second stage element  132 , such as grasper, can hold or release sutures  106  during the pass. 
     In some embodiments, the outer or inner diameter of the shaft of the suture passer  100  can be between about ⅜ inch and about 1 inch. The diameter can be selected based upon the method to be performed. The outer or inner diameter of the suture passing element  104  and the coiled suture passing element  148  can be, for example, between about 1/16 inch and about ⅛ inch for methods for passing a suture around the hyoid bone. 
     The diameter rod or tube used to make the suture passing element  104  can depend on a number of factors. In some embodiments, it may be desirable to have the suture passing element  104  that is stiff. For instance, the suture passing element  104  may need to be stiff enough to penetrate tissue, such as tough connective tissues around the hyoid bone. The suture passing element  104  may need to be large enough to accommodate features described herein, such as suture engagement mechanisms. The suture passing element  104  may need to be large enough to accommodate additional components, such as the second stage element  132 . It may be desirable to design the suture passer  100  as small as possible, for instance, with as small diameter as possible. A small diameter may minimize the amount of injury to the tissue. The diameter of second stage element  132  can be, for example between about 1/16 inch and about ⅛ inch for methods for passing a suture around the hyoid bone. 
     In some embodiments, the suture passing element  104  is subjected to torque. For instance, the suture passing element  104  may be subjected to torque loads when pushed through connective tissue. It can be advantageous, in some embodiments, to minimize deformations that occur when the suture passing element  104  is subjected to torque, load and/or force. The suture passing element  104  may be sufficiently stiff to navigate through connective tissue. The suture passing element  104  can be formed, in some embodiments, from a material (e.g., stainless steel) that has adequate characteristics to resist deformation during the intended use. The second stage element  132  can be formed, in some embodiments, from a material that is super-elastic (e.g., nitinol). 
       FIGS.  11 A- 11 E  illustrate various embodiments of sutures  106 . The sutures described herein can include a variable-thickness suspension line for suspending tissue, including a suture  106  having a first thickness dimension. The suture described herein can include an elastomer surrounding a portion of the suture forming an overmolded segment  150  and defining a central segment of the suspension line having a second thickness dimension greater than the first thickness dimension. The elastomer can be overmolded onto the suture  106 . The elastomer can be, for example silicone. The suture  106  can be braided. The elastomer can be overmolded over a plurality of discontinuous segments of the suture  106 . The central segment of the suspension line can include one or more knots and/or one or more beads for improving adhesion between the suture and the elastomer. The suspension line could have a rounded, and/or a rectangular cross-section. As such, the sutures can either be elastic or inelastic. In some embodiments, elastic sutures can be stretched to at least about 110%, 120%, 130%, 140%, 150%, 175%, 200%, 250%, 300%, or more of their unstretched length. 
     The suture  106  can include at least one transition zone extending from the central segment of the suspension line to a lateral end of the suspension line, the transition zones having a thickness dimension that tapers from the second thickness dimension to the first thickness dimension. The suture  106  can have any features described in commonly owned U.S. patent application Ser. No. 14/020,617, the disclosure of which is incorporated by reference herein. 
     The suture  106  can be a #2 suture, or any other size depending on the desired clinical result (e.g., #1 to #6). The suture  106  can be formed from a suitable material (e.g., braided polyester, braided polyethylene). The suture  106  can include a longitudinal suture optionally coupled with additional features. The suture  106  can include two free ends. The suture  106  can include one, two, or more sections of increased thickness, that can be overmolded segments  150 , or otherwise attached over the suture  106  to increase thickness of the suture. The overmolded segment  150  can be formed from, for example, silicone or other elastomer. The overmolded segment  150  can be silicone compounded with a radiopacifier, such as barium sulfate, and as such be radiopaque under an imaging modality, such as fluoroscopy or CT. In other embodiments, the suture, e.g., the overmolded segment  150 , or a portion thereof is visible under other imaging modalities, such as ultrasound for example. As the suture  106  stretches under load, the overmolded segment  150  will move and stretch with the suture  106 , and can advantageously provide a bearing against wear in some cases. 
       FIG.  11 A  shows a suture  106  with a series of spaced-apart knots  152 , or areas of increased width and/or surface area. The knots  152  can be overhand knots in some embodiments. The longitudinal suture  106  can be knotted to form an integral structure. The series of knots  152  increase adhesion between the suture  106  and the overmolded segment  150 . 
       FIG.  11 B  shows a suture  106  with a suture braid  154 . The suture braid  154  can be formed with the longitudinal first suture  106  and a second suture  106 ′ having the same size (e.g., #2) or a different (e.g., larger or smaller) size (e.g., #5) with respect to the size of the longitudinal first suture  106 . The second suture  106 ′ is braided with the longitudinal first suture  106  and forms a suture sock as shown. The ends of the second suture  106 ′ can be fixed to the longitudinal first suture  106  to prevent fraying. In some embodiments, heat is used to fix the second suture  106 ′ to the longitudinal first suture  106 . The suture braid  154  provides some bulk to the overmolded segment  150 . The suture braid  154  can serve as a bearing. 
       FIG.  11 C  shows a suture  106  with a series of beads  156 . The beads  156  can be rigid or flexible beads. The beads  156  can be formed from a suitable material (e.g., glass). The beads  156  can all have the same diameter, as shown in  FIG.  11 C . The beads  156  can be retained on the longitudinal suture  106  by knots  152  positioned at the end of the beads  156 . The knots  156  can be overhand knots. The knots  152  can be adjacent to the first and last beads  156  or spaced apart from the first and last beads  156 . The beads  156  can serve as a rigid bearing, and in some embodiments advantageously allow the suture  106  to slide, stretch, or otherwise move within the overmolded segment  150 . The beads  156  allow the suture  106  to remain flexible due to the discrete nature of the beads  156 . 
       FIG.  11 D  shows a suture  106  with a series of beads  158 . The beads  158  can have varying diameters as illustrated in  FIG.  11 D . The beads  158  can be formed from a suitable material (e.g., glass). The suture  156  can have similar characteristics as suture  158 . The beads  158  can have different diameters. The diameter of the beads  158  can be selected to accommodate the shape of the overmolded segment  150 . The suture  106  can have two differing diameters of beads  158 . The smaller diameter beads  158  can be located near the suture ends, and the larger diameter beads  158  can be located between the smaller diameter beads  158 , or in a different arrangement. 
       FIG.  11 E  shows suture  106  with a coil  160 . The coil  160  can be formed from a suitable material (e.g., a polymer (e.g., polypropylene), suture, (e.g., #2 or other size monofilament suture), or a metal (e.g., stainless steel)). The coil  160  can be wrapped around the longitudinal suture  106 . The coil  160  can be threaded around the longitudinal suture  106 . The coil  160  can be retained on the longitudinal suture  106  by knots  152  positioned at the end of the coil  160 . The knots  152  can be overhand knots. The knots  152  can be adjacent to the ends of the coil  160  or spaced apart from the ends of the coil  160 . The coil  160  can serve as a bearing. The coil  160  can allow the suture  106  to slide, stretch, or otherwise move within the overmolded segment  150 . The coil  160  allows the suture  106  to remain flexible. The coil  160  of suture  106  may be more flexible than the beads  156 ,  158  of sutures shown in  FIG.  11 C- 11 D . 
       FIG.  12 A  shows an embodiment of the suture  106  before overmolding.  FIG.  12 B  shows the suture  106  after overmolding, with overmolded segment  150 . The length, suture size, and/or overall diameter of the coil  160  can be adjusted depending on the desired clinical result. The coil  160  of suture  106  may be advantageously relatively simple to manufacture. The length, suture size, and/or overall diameter of the overmolded segment  150  can be adjusted depending on the desired clinical result. The overmolded segment  150  of suture  106  may be advantageously relatively simple to manufacture. 
     In some embodiments, the suture  106  and/or suture  106 ′ could be USP #2, or about 0.020″ or less in diameter. In some embodiments, the sections of increased thickness, e.g., the overmolded sections  150 , could be between about 0.080″ to 0.120″, or 0.020″ to 0.030″×0.080″ to 0.120″. In some embodiments, the lengths of the overmolded sections  150  could be between about 2 cm and about 3 cm. The suture  106  with the overmolded section  150  could also include a tapered thickness or diameter section, such as parts of the overmolded sections  150 . The length of the taper could be, for example, less than 1 cm, or less than 0.5 cm. In some embodiments, the first suture  106  could be USP #3, or about 0.024″ or less in diameter. In some embodiments, the overmolded sections  150  could be between about 0.030″ to 0.200″, or 0.020″ to 0.030″×0.030″ to 0.200″, or have a diameter that it at least about 20%, 30%, 40%, 50%, 60%, 75%, 100%, 125%, 150%, 200%, or more larger than that of the underlying suture  106  without overmolding. In some embodiments, the lengths of the overmolded sections  150  could be between about 1 cm and about 5 cm. The length of the taper on either side of the overmolded section  150  or largest diameter/thickest section could be up to about 20%, 30%, 40%, or 50% of the length of the overmolded section  150  or entire large diameter/thickest section. In some embodiments, additional suture  106  and other features that can be used or modified for use with embodiments disclosed herein can be found, for example, in U.S. patent application Ser. No. 14/020,617 to Feezor et al., which is hereby incorporated by reference in its entirety. 
     The surface of any of the disclosed sutures may be mechanically, chemically, or otherwise modified to improve adhesion with, for example, muscle cells and other tissues of the genioglossus. Mechanical modifications create improved adhesion by modifying the surface texture of the implant and may be achieved as part of the manufacturing process and may involve the removal of material from, or the addition of material to the surface of the implant. Chemical adhesion may be achieved through the incorporation of chemical (including biological) compounds into the surface or the bulk material or materials that makes up the implant in order to improve the affinity between cellular components and the implant. Compounds may include, but are not limited to proteins, peptides, antibodies, growth factors, or other molecules which create an affinity for cellular or tissue components. 
       FIGS.  13 A- 13 D  illustrate a method of narrowing the lateral pharyngeal wall. Some surgical procedures indirectly tension the lateral pharyngeal wall. The technique involves a plurality, e.g., two, three, or more suture passes around the superior pharyngeal constrictor muscle. The sutures are sewn into the palatoglossal muscle and tied off as shown. The aforementioned technique can require exposure of muscle with several incisions in the mucosa layer, and the technical ability to consistently anchor the suture in the superior pharyngeal constrictor muscle. The technique can also require the ability to consistently anchor the suture in the palatoglossal muscle. In some cases, there may be increased pain and recovery time for patients due to the mucosal incisions. 
     In some embodiments, as illustrated in  FIG.  14   , a barbed implant  162  can be utilized. The barbed implant  162  can include a first end  164  and a second end  166 . The first end  164  can include one or more barbs. The second end  166  can include one or more barbs. The barbs on the first end  164  can point in a first direction away from the second end  166 . The barbs on the second end  166  can point in a second direction away from the first end  164 . In other embodiments, the barbs can point in the same direction. The barbed implant  162  can have a longitudinally extending portion between the first end  164  and the second end  166 . In some embodiments, the longitudinally extending portion does not include barbs as shown in  FIG.  14   . In other embodiments, the longitudinally extending portion includes barbs. The barbed implants  162  can be elastic or inelastic. The longitudinally extending portion can be elastic or inelastic. The barbs can generally move in one direction (e.g., to be inserted into tissue). The barbs resist movement in an opposite direction (e.g., to prevent back out of the barbed implant  162 ). 
     The system can include one or a plurality (e.g., about or at least about 2, 3, 4, 5, 6, or more) of barbed implants  162 . The barbs can function as proximal and/or distal anchors. The barbed implant  162  can be implanted into tissue  300 . The barbed implant  162  can be horizontally oriented within the body of the patient. The method of use can include an implant inserter tool  168 . The implant inserter tool  168  can include a proximal handle, an elongate shaft, and a distal tip. The barbed implant  162  can be implanted by advancing an implant inserter tool  168  in a generally horizontal orientation. The implant inserter tool  168  can release the barbed implant  162  into the tissue  300 . In some embodiments, the barbed implants  162  could be implanted within about 10 degrees of the horizontal axis. However, in other embodiments, the barbed implants  162  could be within less than about 15 degrees, 30 degrees, 45 degrees, 60 degrees, 75 degrees of the horizontal axis. This provides more localized control of tissue suspension, depending on the desired clinical result. 
     In some methods of use, a combination of generally horizontally-oriented barbed implants  162  can be used as shown in  FIG.  14   . In some methods of use, a combination of generally horizontally oriented barbed implants  162  and generally vertically-oriented barbed implants  162  can be used. In some methods of use, a combination of generally vertically-oriented barbed implants  162  can be used. In some embodiments, the distance between barbed implants  162  could be irregular or regular. The distance between the midlines of the barbed implants  162  could be, for example, between about 0.1 cm and about 3 cm. The barbed implants  162  can have the same or different orientations within the tissue  300 . In some instances where additional suture strength is required at a single location within tissue, the multiple barbed implants  162  may share a midline axis, but be oriented differently (from −90 to +90 degrees) from each other. 
       FIG.  14    illustrates three barbed implants  162  deployed in the tissue  300 . As shown, the barbed implants  162  are used to tack the superior pharyngeal constrictor muscle to the palatoglossal muscle. The barbed implants  162  may extend from the palatoglossal arch to the palatopharyngeal arch. The barbed implants  162  may each include a longitudinal extending section, the first end  164  and the second end  166 , as described herein. The barbs of the first end  164  may be oriented the same as, or differently from the barbs on the second end  166 . The barbs on the first end  164  may be opposite the orientation of the barbs on the second end  166 . The barbs may be configured to engage tissue  300  when tensioned from different directions. 
       FIGS.  15 A- 15 B  illustrates a cross-sectional view of the palatoglossal arch and the palatopharyngeal arch.  FIG.  15 A  shows the barbed implant  162  deployed. The barbed implant  162  compresses the palatopharyngeal arch toward the palatoglossal arch.  FIG.  15 B  illustrates a cross-sectional view of the anatomy without the barbed implant  162 . The barbed implant  162  can be deployed at an angle relative to the horizontal. The angle may be approximately 45 degree. The angle can be determined by the relative anatomy of the patient. 
       FIGS.  16 A-D  illustrate a method of inserting the barbed implant  162 .  FIG.  16 A  shows the implant inserter tool  168  having the proximal handle, the elongate shaft, and the distal tip. The implant inserter tool  168  can be inserted into and extends between the palatoglossal arch and the palatopharyngeal arch. The implant inserter tool  168  can be advanced until the distal tip is proximate a target location.  FIG.  16 B  shows the barbed implant  162  being deployed from the distal tip of the implant inserter tool  168 . This can be accomplished, for example, by actuating a control on the proximal handle to actuate a pushrod distally, for example to expel the barbed implant  162 . The first end  164  of the barbed implant  162  engages tissue  300  of the palatopharyngeal arch. In some embodiments, the barbs may further embed in the tissue  300  as a force is applied to the barbed implant  162 . The barbs of the barbed implant  162  dig into or otherwise embed in the soft tissue  300 . The tool  168  is retracted from the palatopharyngeal arch. 
       FIG.  16 C  shows the tool  168  being retracted to the palatoglossal arch. By applying a force (e.g., tension) on the barbed implant  162 , the barbs may further embed in the tissue  300 . The palatopharyngeal arch may be brought toward the palatoglossal arch. The palatopharyngeal arch may be compressed against the palatoglossal arch. In some embodiments, the palatopharyngeal arch may touch the palatoglossal arch. The palatopharyngeal arch may be pulled laterally and/or anteriorly. 
       FIG.  16 D  shows the implant inserter tool  168  being retracted from the palatoglossal arch. The second end  166  of the barbed implant  162  engages tissue  300  of the palatoglossal arch. The barbed implant  162  may be deployed such that the first end  164  engages the palatopharyngeal arch and the second end  166  engages the palatoglossal arch. As force is applied to the barbed implant  162 , the barbs may further embed into the soft tissue  300 , thereby inhibiting further movement of the barbed implant  162 . The method steps shown in  FIGS.  16 A- 16 D  can be repeated to deploy one or more barbed implants  162  on one or more sides of the airway. 
     In some cases, the method can include several advantages depending on the desired clinical result. The technique can leave the mucosa layer intact. The barbed implants  162  can be anchored to a larger tissue area than the sutures, in some embodiments. The technique is a simple, repeatable process providing dependable results. The technique may produce a large clinical benefit for minimally invasive intervention. 
       FIGS.  17 A- 17 B  illustrate embodiments of the barbed implant  162  with tissue ingrowth material  170 . The tissue ingrowth material  170  may be located near the first end  164 . The tissue ingrowth material  170  may be located near the second end  166 . The tissue ingrowth material  170  may be located near the first end  164  and near the second end  166 . The tissue ingrowth material  170  may be located beyond the first end  164 . The tissue ingrowth material  170  may be located beyond the second end  166 . The tissue ingrowth material  170  may be located beyond the first end  164  and beyond the second end  166 . The tissue ingrowth material  170  may provide long-term stability of the barbed implant  162 . The tissue ingrowth material  170  may prevent migration of the barbs out of the tissue. The tissue ingrowth material  170  can be biocompatible, to prevent rejection of the barbed implant  162  by the body of the patient. The tissue ingrowth material  170  and may include one or more drugs or other therapeutic agents. 
       FIGS.  18 A- 18 B  illustrate a method of inserting the barbed implant  162 .  FIG.  18 A  shows the implant inserter tool  168  inserted into the palatopharyngeal arch. The implant inserter tool  168  is advanced until the distal tip is located at a target location.  FIG.  18 A  shows the barbed implant  162  being deployed from the distal tip of the implant inserter tool  168 . The barbed implant  162  engages tissue  300  of the palatopharyngeal arch. In some embodiments, the barbs may further embed in the tissue as a force is applied to the barbed implant  162 . The barbs of the barbed implant  162  dig into or otherwise embed in the soft tissue. The implant inserter tool  168  is retracted from the palatopharyngeal arch.  FIG.  18 B  shows the implant inserter tool  168  retracted. The barbed implant  162  spans from the palatopharyngeal arch to the base of the palatoglossal arch. The barbed implant  162  compresses the palatoglossal arch. By applying a force (e.g., tension) on the barbed implant  162 , the barbs may further embed in the tissue. The palatopharyngeal arch may be brought toward the palatoglossal arch. The palatopharyngeal arch may be pulled laterally. This technique avoids tacking the palatopharyngeal arch directly to the palatoglossal arch. 
       FIGS.  19 A- 19 E  illustrate a method of inserting a suture  106  for a tissue lift procedure. The suture  106  can include the overmolded segment  150  as described herein.  FIG.  19 A  shows the method step of making an incision in the skin of the head of a patient.  FIG.  19 B  shows the method step of making a small surgical dissection pocket.  FIGS.  19 C- 19 E  show various non-limiting possible suture passes. Path A provides neck lift, Path B provides mid-level cheek lift, and Path C provides eye line lift, as shown in  FIG.  19 C . Path D, as shown in  FIG.  19 D , shows the path wherein the suture passes inferiorly to the mandible. The suture is advanced until reaching the midline of the neck. The method may include the step of placing suspension sutures such as suture  106  with the overmolded segment  150  under the jaw line. Path E, as shown in  FIG.  19 E  illustrates the path of suture  106  forming loops in the neck. The method may include the step of suspending a suture, trimming extra skin, and/or closing the incision. The sutures may be placed using the SMAS, or the sub-muscular aponeurotic system. The system and methods, such as the use of various suture passers, can be as disclosed herein and can be, or modified from systems and methods described in U.S. Pat. No. 8,460,322, the entire disclosure of which is incorporated by reference. 
       FIG.  20    illustrate a method of inserting a suture  106 . The suture  106  can include the overmolded segment  150  as described herein. The methods can be performed by a suture passer described herein and in commonly owned U.S. Pat. No. 8,460,322, the entire disclosure of which is incorporated by reference. The suture passer can be modified, (e.g., reduced in size). The suture passer can be used to place suture  106 . The suture  106  can form loops within the tissue instead of single short sections of suture. The suture passer can place suture  106  into the superior pharyngeal constrictor muscle. The suture  106  can be placed as shown. The suture  106  can be placed near the palatopharyngeal arch, the palatoglossal arch and/or any location between the palatopharyngeal arch and the palatoglossal arch. The suture  106  can be anchored. The suture  106  can be anchored into palate tissue and/or the hard palate. The suture  106  can be tensioned to stabilize the lateral pharyngeal wall. The method can in some embodiments narrow the lateral pharyngeal wall and/or provide the lateral pharyngoplasty. 
       FIGS.  21 A- 21 B  illustrate a method of using one or more bone anchors  172  in an adjustable tensioning system. The bone anchors  172  can be knotless bone anchors in some embodiments. The suture  106  can be inserted into the bone anchors  172 . In some embodiments, the suture  106  includes a first strand  106 A, a second strand  106 B and an arc connecting the first strand  106 A and the second strand  106 B. The first strand  106 A has a free end and the second strand  106 B has a free end. The free ends of the suture  106  can be inserted into a lumen of the bone anchor  172 . The bone anchor  172  can be tightened to secure the first strand  106 A and the second strand  106 B. The bone anchor  172  can be loosened to release the first strand  106 A and the second strand  106 B and allow for adjustable tensioning without necessarily requiring untying of the suture loop. 
     The bone anchors  172  can be used to secure the suture  106  within the face or neck, or another desired anatomical location. The suture  106  can form a loop such that the suture arc  106 C is disposed within the tissue. The sutures  106  may be placed to provide a face and/or neck lift. 
     The bone anchor  172  can provide post-operative adjustability to the suture  106 . For instance, the suture  106  can be adjusted after the arcs  106 C are placed, during the procedure and/or at any time in the future. The suture  106  could be adjusted days, months, or years after the suture  106  is placed within the body. The bone anchor  172  permits adjusting the suture  106  by increasing or decreasing tension in a minimally invasive manner. In some embodiments, the bone anchor  172  can selectively release the first strand  106 A. In some embodiments, the bone anchor  172  can selectively release the second strand  106 B. In some embodiments, the bone anchor  172  can selectively release the first strand  106 A and the second strand  106 B. The surgeon can apply tension to the first strand  106 A and/or the second strand  106 B. Once adjusted, the bone anchor  172  can be tightened to retain the first strand  106 A and the second strand  106 B. The bone anchor  172  permits adjusting the face and/or neck lift in a minimally invasive manner. The free ends of the suture  106  may be pulled, slid, tensioned and/or manipulated to adjust the suture  106 . This movement would then adjust the tissue, bone, and/or skin coupled to the suture  106  (e.g., adjust the face and neck lift). 
     The bone anchor  172  can have lock and unlock capabilities. The bone anchor  172  can include an opening (e.g., a hexagonal opening) for the insertion of a tool (not shown). The tool can lock and unlock the bone anchor  172 , allowing for the suture  106  to be adjusted. The bone anchor  172  may be implanted on a surface of the skin and/or within the body. The bone anchor  172  can be placed above the ear (e.g., in the temporal bone), as shown in  FIG.  21 A . The bone anchor  172  can be placed under the skin near the ear, as shown in  FIG.  21 B . The bone anchor  172  placed under the skin can be adjusted by making a small incision near the bone anchor  172 . The incision may be near the implantation location for the bone anchor  172 . The tool can be inserted into the incision to adjust the bone anchor  172 . 
       FIGS.  22 A- 22 B  illustrate a tool  176  and method for moving the superior pharyngeal constrictor or another desired muscle. The tool  176  can move the superior pharyngeal constrictor muscle in any direction (e.g., laterally and/or anteriorly). The tool  176  can stabilize the superior pharyngeal constrictor muscle in the desired location (e.g., laterally and/or anteriorly). The tool  176  can insert a fastener  178  (e.g., a tack, staple, cap, suture loop, or suture). The fastener  178  can be biodegradable or bioabsorbable in some cases. The tool  176  can include a blunt tip for moving the tissue. The tool  176  can couple to the fastener  178  for stabilizing the tissue.  FIG.  22 A  shows the tool  176  moving the superior pharyngeal constrictor muscle laterally. The tool  176  can move the superior pharyngeal constrictor muscle via the blunt tip. The superior pharyngeal constrictor muscle may be moved toward the side of the airway. The tool  176  can be positioned to discharge (e.g., launch, fire) the fastener  178  to stabilize the tissue. The method can be repeated for the contralateral side of the airway to move the superior pharyngeal constrictor muscle laterally. 
       FIGS.  23 A- 23 C  illustrate some embodiments of the fastener  178 , with the placement of the fastener  178  shown in relation to the superior pharyngeal constrictor muscle.  FIG.  23 A  shows the fastener  178  as a staple, with ends biased toward each other.  FIG.  23 B  shows the fastener  178  as a tack, having a proximal tissue contacting structure and a distal tissue contracting structure, both operably connected to a tension element.  FIG.  23 C  shows the fastener  178  as the suture  106 . The suture  106  can form a loop by bringing the first end  106 A to the second end  106 B. The suture  106  can be stabilized with anchors as described herein. The suture  106  can be placed with a device like a suture passer as described herein. The fastener  178  can be a barbed suture  162 , as shown in  FIG.  14    for example. The fastener  178  can be bioabsorbable in some embodiments. The fastener  178  can extend from the superior pharyngeal constrictor muscle to a location near the palatopharyngeal arch, the palatoglossal arch and/or any location between the palatopharyngeal arch and the palatoglossal arch. The fastener  178  can extend from the fascia behind the superior pharyngeal constrictor muscle. 
       FIGS.  24 A- 24 D  illustrate a method of hyoid suspension. The hyoid bone is located in the anterior midline of the neck and is anchored by muscles. The hyoid aids in tongue movement and swallowing. Hyoid suspension involves pulling the hyoid forward in order to increase the size of the airway.  FIG.  24 A  illustrates the method step of forming an incision in the neck of a patient. The incision can be, for example, between 2 cm and 4 cm. The incision may extend from, for example, the hyoid bone to the mandible. The surgeon can dissect the tissue and muscle to reach the hyoid bone. 
       FIG.  24 B  illustrates the method step of using a suture passer for hyoid suspension. The method may utilize a suture passer substantially similar to the systems and methods described herein or in commonly owned U.S. Pat. No. 8,460,322, the entire disclosure of which is incorporated by reference. The suture passer can be used to pass a suture loop  106  around the body of the hyoid bone. The suture  106  can include the overmolded segment  150 . The suture  106  has the first strand extending longitudinally  106 A, the second strand extending longitudinally  106 B, and the arc  106 C connecting the first strand  106 A and the second strand  106 B. The arc  106 B is passed around the hyoid bone. The suture loop  106  can be elastic or inelastic. The suture  106  can be substantially similar to the sutures described herein, including the sutures shown in  FIGS.  11 A- 12 B . The arc  106 C can be on one side of the hyoid bone. The first  106 A and second strand  106 B can be on the other side of the hyoid bone. In some methods, the first strand  106 A and the second strand  106 B are then passed around the hyoid bone. The first strand  106 A and the second strand  106 B are passed under the arc  106 B. The suture  106  can form a girth hitch. Other knot configurations are contemplated. For instance, the suture  106  could be wrapped around the hyoid bone forming a klemhiest or prusik knot. 
     The first suture  106  can be replaced with a second, larger suture  108 . The larger suture  108  can include be a larger diameter suture, suspension loop, suture tape, etc. The larger suture  108  can be similar to suture  106 . The larger suture  108  can prevent erosion through the bone. The second, larger suture  108  can be elastic. The larger suture  108  can include the overmolded segment  150  as described herein. The suture  108  has a first strand extending longitudinally  108 A, a second strand extending longitudinally  108 B, and an arc  108 C connecting the first strand  108 A and the second strand  108 B. 
     In some methods of use, the first strand  106 A is passed around the hyoid bone. The arc  106 C can be in contact with the hyoid bone. The second strand  106 B can be on the other side of the hyoid bone. The suture  106  can be used to place the suture  108 , akin to a guide suture. In some methods, the arc  108 C can be placed around the first strand  106 A. The arc  108 C can be operably coupled to the first strand  106 A. The suture  106  can be pulled. In some embodiments, the second strand  106 B of the suture  106  is pulled. The arc  108 C can be on one side of the hyoid bone. The first  108 A and second strand  108 B can be on the other side of the hyoid bone. In some methods, the first strand  108 A and the second strand  108 B are then passed around the hyoid bone. The first strand  108 A and the second strand  108 B are passed under the arc  108 B. The suture  108  can form a girth hitch. Other knot configurations are contemplated. For instance, the suture  108  could be wrapped around the hyoid bone forming a klemhiest or prusik knot. 
     In some methods of use, the arc  106 C is passed around the hyoid bone as shown in  FIG.  24 C . The arc  106 C is on one side of the bone and the first strand  106 A and the second strand  106 B can be on the other side of the hyoid bone. In some methods, the arc  108 C can be placed under the arc  106 C. The suture loop  106  can be pulled. In some embodiments, the first strand  106 A and the second strand  106 B of the suture  106  are pulled. The arc  108 C can be on one side of the hyoid bone. The first  108 A and second strand  108 B can be on the other side of the hyoid bone. In some methods, the first strand  108 A and the second strand  108 B are then passed around the hyoid bone. The first strand  108 A and the second strand  108 B are passed under the arc  108 B. The suture  108  can form a girth hitch. Other knot configurations are contemplated.  FIG.  24 C  shows the method of pulling the larger suture  108 , which can be operably connected to the smaller guide suture  106  in some embodiments. 
       FIG.  24 D  illustrates the method step of securing the suture  106  and/or larger suture  108  to the mandible. The method may utilize a bone anchor  178 , which can include any or all of the features of bone anchor  178  described herein. The bone anchor  178  can be a knotless bone anchor. The bone anchor  178  can be a locking bone screw. The loop of the suture  106  and/or larger suture  108  provides a knotless attachment to the hyoid bone. 
     The tension, position, and/or suspension of the hyoid bone can be adjusted by adjusting the loop of the suture  106  and/or larger suture  108 . For instance, pulling on the first strand  106 A and/or the second strand  106 B can change the position of hyoid bone. For instance, changing the location of the suture  106  relative to the hyoid bone can change position of the hyoid bone. 
     The bone anchor  178  can allow for post-operative adjustment of the suture  106  and/or larger suture  108 . The bone anchor  178  can release the first strand  108 A and or the second strand  108 B. The surgeon can adjust the tension provided by the first strand  108 A and the second strand  108 B. The larger suture  108  can be adjusted after the knot is placed, and/or at any time in the future. The larger suture  108  could be adjusted days, months, years after the larger suture  108  is placed within the body. The larger suture  108  can be adjusted acutely or chronically. The method of passing the suture  106 ,  108  around the hyoid bone may be simpler, easier, and more minimally invasive than using a curved needle. Although  FIG.  24 D  shows one larger suture  108 , more than one larger suture  108  can be utilized (e.g., two girth hitch knots, three girth hitch knots, etc.). The thickness, strength, and/or other material properties may be selected to minimize the number of larger sutures  108 . A single larger suture  108  of a sufficiently thick and/or strong material may be able to stabilize the hyoid bone with respect to the mandible. 
       FIG.  25 A- 25 B  illustrate a suture passer, in particular the distal end of the suture passer. The suture passer  182  can be modified from the suture passer described in commonly owned U.S. Pat. No. 8,460,322, the entire disclosure of which is incorporated by reference. The suture passer  182  can be modified to include one or more sharpened suture passing needles  184 . The sharper needles  184  may be configured for passing through tissues having a greater inherent resistance to puncture, such as ligaments (e.g., hyoepiglottic ligaments, hypothyroid ligaments). The design and/or material of the needle  184  may be selected to enhance stiffness. 
     The suture passer  182  can be modified to include one or more sharp tips  186 . The sharp tips  186  on the ends of the suture passer  182  may be useful in passing through ligaments as noted above. The suture passer  182  can include a depth stop  188  which may limit the forward movement of the suture passer  182 . The depth stop  188  may serve as a safety measure, to prevent the suture passer  182  from puncturing the airway. Alternatively, the tips could be blunt and atraumatic in some embodiments. 
       FIG.  25 B  illustrates the placement of the suture passer  182  within the body of the patient. The sharp tips  186  may surround the hyoid bone. The needle  184  may penetrate the hyoepiglottic ligament. The needle  184  may extend from one sharp tip  186  to the other sharp tip  186  in order to pass the suture. Surrounding structures such as the hyothryoid ligament, thyroid cartilage, and epiglottis are also shown for reference. 
       FIG.  26 A- 26 B  illustrate a method of hyoid bone suspension.  FIG.  26 A  illustrates the method step of forming a girth hitch around the hyoid bone.  FIG.  26 A  utilizes two sutures  106  (e.g., #2 suture, suture tape (e.g., 2 mm suture tape)). One, two, or more girth hitch knots may be utilized as shown in  FIG.  26 A . The first strand  106 A and the second strand  106 B pass under the arc  106 C. The first strand  106 A and the second strand  106 B of the suture  106  are secured to a bone anchor  178 . The bone anchor  178  can be located on the mandible. The bone anchor  178  can be tightened to securely hold the first strand  106 A and the second strand  106 B. The bone anchor  178  can be loosened to release the first strand  106 A and the second strand  106 B. The surgeon can alter the tension applied to the hyoid bone. The bone anchor  178  can be tightened after the adjustment.  FIG.  26 A  shows a configuration with two side-by-side girth hitch knots, and two bone anchors  178 .  FIG.  26 B  shows a configuration with one girth hitch knot illustrated using suture tape, and three bone anchors  178 . Additional girth hitch knots utilizing sutures  106  may be utilized in  FIG.  26 B  with respect to the remaining bone anchors  178 . The ratio of girth hitches or other knots to bone anchors  178  may be greater than 1:1 (2 girth hitches to 1 bone anchors) or equal to 1:1 (2 girth hitches to 2 bone anchors) in some embodiments. The ratio of sutures  106  to bone anchors  178  may be greater than 1:1 (2 girth hitches to 1 bone anchors) or equal to 1:1 (2 girth hitches to 2 bone anchors) in some embodiments. 
       FIG.  27 A- 27 D  illustrates a method of forming a girth hitch, in some embodiments. The suture  106  includes the first strand  106 A, the second strand  106 B, and the arc  106 C.  FIG.  27 A  shows the method step of conducting a pass with a suture passer. The suture  106  may be folded, held or otherwise coupled to the suture passer.  FIG.  27 B  shows the method step of retracting the suture passer and/or the needle of the suture passer. The arc  106 C remains within the body.  FIG.  27 C  illustrates passing the first strand  106 A and the second strand  106 B of the suture  106  through the arc  106 C of the suture  106  to form a girth hitch.  FIG.  27 D  illustrates the method step of tensioning the first strand  106 A and the second strand  106 B of the suture  106  to form a girth hitch. The first strand  106 A and the second strand  106 B of the suture  106  can be coupled to a bone anchor  178  as described herein. The bone anchor  178  can be attached to the mandible. The suture  106  may be either pre-attached to the bone anchor  178  prior to the procedure, or following formation of the girth hitch. The suture  106  can be a smaller diameter guide suture. In some methods, the suture  106  can be coupled with a larger diameter suture  108 , which can follow the path of the guide suture  106  to create a girth hitch. In some methods, the arc  108 C of the larger diameter suture  108  can be passed under the arc  106 C of the suture  106 C to create a girth hitch. 
     The method illustrated in  FIG.  27 A- 27 D  illustrates the creation of a girth hitch around the hyoid bone at the midline (e.g., near the midline, substantially near the midline). The girth hitch may be connected to a bone anchor  178 . The bone anchor  178  may be attached to the mandible at the midline (e.g., near the midline, substantially near the midline). 
     Alternatively two girth hitch knots may be deployed. The girth hitch knots may be coupled to the hyoid bone. The two girth hitch knots can be around the hyoid bone. The two girth hitch knots can be placed on either side (e.g., right side, left side) of the midline of the hyoid bone, as shown in  FIGS.  26 A and  28   . In some embodiments, the two girth hitch knots can be coupled to two bone anchor  178 . The two bone anchors  178  can be placed on either side (e.g., right side, left side) of the midline of the mandible, as shown in  FIG.  26 A . In some embodiments, the two girth hitch knots can be coupled to a single bone anchor  178 . The single bone anchor  178  can be placed at the midline of the mandible (e.g., near the midline, substantially near the midline), as shown in  FIG.  28   . The single bone anchor  178  can be placed on either side (e.g., right side, left side) of the midline of the hyoid bone. 
       FIGS.  29 A- 29 C  illustrate an embodiment of a hyoid suspension implant  192  (e.g., an alternative to, or can be combined with the suture).  FIG.  29 A  illustrates an implant  192 . The implant  192  can include an implant head  192 A, that can have a relatively larger width dimension, and a longitudinally extending tail  192 B having a relatively smaller width dimension. The implant head  192 A includes a slot or other feature designed to accept the longitudinally extending tail  192 B.  FIGS.  29 B- 29 C  show a method of using the implant  192 . The implant  192  can be passed behind the hyoid bone. The implant head  192 A is passed around the hyoid bone. The longitudinally extending tail  192 B can be passed through the slot in the implant head  192 A. The longitudinally extending tail  192 B is tensioned. The implant  192  wraps around the hyoid bone, as shown in  FIG.  29 C . In some methods, the longitudinally extending tail  192 B is passed around the hyoid bone. The longitudinally extending tail  192 B can be passed through the slot in the implant head  192 A. The longitudinally extending tail  192 B can be tensioned. The implant  192  wraps around the hyoid bone, as shown in  FIG.  29 C . 
     The implant head  192 A, including the slot, and/or the longitudinal extending tail  192 B can have additional features. The implant can include a locking mechanism. The locking mechanism can be a ratchet formed within or on the implant head  192 A, the slot, and/or the longitudinal extending tail  192 B. The locking mechanism can lock the implant  192  against the hyoid bone once the implant  192  has been tensioned.  FIG.  30    shows an embodiment of the locking mechanism, surrounding a cross-section of a body structure, such as the hyoid bone. The longitudinally extending tail  192 B includes teeth and/or ratchets that engage the slot. The slot includes teeth and/or ratchets that engage the longitudinally extending tail  192 B. The locking mechanism locks the implant  192  in place after the implant  192  has been tensioned. The bone anchors  178  can also include teeth and/or ratchets that engage the longitudinally extending tail  192 B. The longitudinally extending tail  192 B can include teeth and/or ratchets that engage the bone anchor  178 . The teeth and/or ratchet can provide a knotless method of locking the implant to the bone anchor. 
     The implant  192  can be manufactured from a biocompatible material (e.g., plastic). The implant  192  can be formed from any process (e.g., braiding suture). The teeth and/or ratchet can be formed into the implant (e.g., crimped into the suture). The teeth and/or ratchet can take any shape (e.g., balls, triangular teeth, and/or slits). 
       FIG.  31    illustrates a method of attaching an implant to a hyoid bone. The method can include the step of drilling a small hole in the hyoid bone (e.g., a through hole). The implant  194  can be passed through the hole. The implant  194  can be reduced in diameter in order to fit through the small hole. The implant  194  can have a collapsed configuration and an expanded configuration. The implant  194  can be passed through the hole in the collapsed configuration. The implant  194  can be expanded to the expanded configuration after passing through the small hole. In the expanded configuration, the implant  194  cannot pass through the hole. For instance, the implant  194  can have a generally T-shaped configuration as shown in  FIG.  31   . The T-shape prevents the implant  194  from passing through the hole in the hyoid bone. A suture  106  (e.g., suture, suture tape) can be attached to the implant  194 . The implant  194  can include a longitudinally extending tail  194 B. The suture  106  can be coupled to the longitudinally extending tail  194 B. The longitudinally extending tail  194 B can be disposed within the hole. The suture  106  and/or longitudinally extending tail  194 B can be connected to the bone or tissue (e.g., mandible, thyroid cartilage). 
     The implant  194  can be constructed from a material suitable for expanding (e.g., super elastic metal or plastic). The implant  194  can be constrained in the collapsed configuration, having a small diameter for delivery and/or insertion into the hole. The implant  194  can be constrained by a sheath. The implant  194  is allowed to expand once delivered and/or once the restraint is removed. The expanded configuration has a larger diameter than the collapsed configuration. 
       FIGS.  32 A- 32 B  illustrates a method of attaching an implant to a hyoid bone. The method can include the step of drilling a small hole in the hyoid bone (e.g., a through hole). The implant  195  can be passed through the hole. The implant  195  can have a reduced diameter configuration in order to fit through the small hole. The implant  195  can have a collapsed configuration and an expanded configuration. The implant  195  can be passed through the hole in the collapsed configuration. The implant  195  can be expanded to the expanded configuration after passing through the small hole. In the expanded configuration, the implant  195  cannot pass through the hole.  FIGS.  32 A- 32 B  illustrate an embodiment of the implant  195 . The implant  195  can include barbs  196 . For instance, the barbs  196  can have a generally J-shaped configuration as shown in  FIG.  32 B . The J-shape prevents the implant  195  from passing through the hole in the hyoid bone. The barbs  196  can be formed from a material suitable for expanding (e.g., super elastic metal or plastic).  FIG.  32 A  shows the barbs  196  in the collapsed configuration. The barbs  196  can be constrained by a sheath. The barbs  196  can be constrained by the small hole. The implant  195  can be coupled to a suture  106 .  FIG.  32 B  shows the barbs  196  in the expanded configuration. The sheath has been removed. The barbs  196  can have a larger diameter preventing the barbs  196  from passing back through the small hole. 
       FIG.  33 A- 33 B  illustrates a method of attaching an implant to a hyoid bone. The method can include the step of drilling a small hole in the hyoid bone (e.g., a through hole). The implant  197  can be passed through the hole. The implant  197  can be reduced in diameter in order to fit through the small hole. The implant  197  can have a collapsed configuration and an expanded configuration. The implant  197  can be passed through the hole in the collapsed configuration. The implant  197  can be expanded to the expanded configuration after passing through the small hole. In the expanded configuration, the implant  197  cannot pass through the hole.  FIGS.  33 A- 33 B  illustrate an embodiment of the implant  197 . The implant  197  can include a suture  198 . The implant  197  can have a collapsed configuration wherein the suture  198  extends along a longitudinal axis. The implant  197  can have an expanded configuration wherein the suture  198  forms a suture ball.  FIG.  33 A  shows the implant  197  in the collapsed configuration. The suture  198  can be constrained by a sheath. The suture  198  can be constrained by the small hole.  FIG.  33 B  shows the implant  197  in the expanded configuration. The suture  198  can have a larger diameter preventing the implant  197  from passing back through the small hole. The implant  197  can be coupled to suture  106 . The implant  197  and/or the suture  106  may be coupled to a bone or tissue (e.g., mandible). 
       FIGS.  34 A- 34 F  illustrate an embodiment of a suture passer  200 . The suture passer  200  can include a first section  202 . The first section  202  can include a first handle  204 . The first section can include a first tip  206 . The first section  202  can be coupled to a second section  208 . The first section  202  can be joined with, for example, a pivot pin to the second section  208  akin to a scissors tool. The second section  208  can include a second handle  210 . The second section  208  can include a second tip  212 . 
     The first tip  206  can form a jaw. The second tip  212  can form a jaw. The jaw can be curved. The jaw can include serrations or other features to improve grip to the bone or other tissue. The curvature of the jaw can allow the first tip  206  to surround a portion of a body structure, such as the hyoid bone. In some embodiments, the first tip  206  surrounds approximately 180 degrees of the hyoid bone. In some embodiments, the first tip  206  surrounds greater than 180 degree of the hyoid bone, approximately 270 degrees of the hyoid bone, greater than 270 degrees of the hyoid bone, etc. The curvature of the jaw can allow the second tip  212  to surround a portion of the hyoid bone. In some embodiments, the second tip  212  surrounds approximately 180 degrees of the hyoid bone. In some embodiments, the second tip  212  surrounds greater than 180 degree of the hyoid bone, approximately 270 degrees of the hyoid bone, greater than 270 degrees of the hyoid bone, etc. The first tip  206  and the second tip  212  can surround the entire hyoid bone or a substantial portion thereof. 
     The assembly can include a plunger  216 . The plunger  216  can include a head  214 . The head  214  can have an enlarged cross-sectional area. The head  214  can guide the plunger  216 . The plunger  216  can be flexible and/or elastic. As shown in  FIG.  34 B , the first section  202  can include a slot  218 , either distal or proximal to the pivot. The slot  218  can be sized to accept the plunger  216 . The slot  218  can be smaller than the diameter of the head  214  to limit the head  214  from passing through the slot  218 . The slot  218  can be located on the opposite side of the pivot as the first handle  204 . The slot  218  can be tapered. The slot  218  can extend from a surface  220  of the first section  202  to an interior lumen  222  of the first section  202  as described herein. 
     The plunger  216  can include a suture engagement mechanism. The suture engagement mechanism can be similar to the suture engagement mechanisms described herein for example with references to  FIGS.  4 A- 4 D . The suture engagement mechanism can include slots, holes, notches or lumens to engage the suture  106 . The plunger  216  can engage the suture  106  to pass the suture  106 . 
     As shown in  FIG.  34 C , the second tip  212  can include an interior lumen  224 . The interior lumen  224  can be sized to accept the plunger  216 . In some embodiments, the second section  208  can include a slot (not shown). The slot on the second section  208  can be substantially similar to slot  218 . The slot can be located on the opposite side of the pivot as the second handle  210 . The slot on the second section  208  can be tapered. The slot on the second section  208  can extend from a surface of the second section  208  to the interior lumen  224  of the second section  202 . 
     The interior lumen  222  of the first section  202  and the interior lumen  224  of the second section  202  can be aligned when the first tip  206  and the second tip  212  are brought together as shown in  FIG.  34 B . The interior lumens  222 ,  224  can form a continuous channel for the plunger  216  between the proximal slot opening on a sidewall and the distal-facing tip opening. The interior lumen  222  of the first section  202  is open at the first tip  206 . The interior lumen  224  of the second section  208  is open at the second tip  212 . This allows the plunger  216  to pass between the first section  202  and the second section  208 . 
     As shown in  FIG.  34 D , the suture passer  200  is advanced toward the hyoid bone. The suture passer  200  can be passed through a submental incision. The first tip  206  can be pivoted to surround the hyoid bone. The second tip  212  can be pivoted to surround the hyoid bone. The first tip  206  and the second tip  212  can be pivoted separately or simultaneously. The first tip  206  can be pivoted by actuating the handle  204 . The second tip  212  can be actuated by pivoting the handle  210 . The tips  206 ,  212  are brought toward each other. In some embodiments, the tips  206 ,  212  touch. In some embodiments, the tips  206 ,  212  are in close proximity. In some embodiments, a small gap is formed between the first tip  206  and the second tip  212 . The interior lumen  222  of the first section  202  and the interior lumen  224  of the second section  208  are aligned when the tips  206 ,  212  are brought together. In some methods, the action of closing the tips  206 ,  212  stabilizes the suture passer  200  against the hyoid bone. 
       FIG.  34 E  shows that the plunger  216  can enter the slot  218  of the first section  202 . The plunger  216  can be guided by the head  214 . The plunger  216  can enter the interior lumen  222  of the first section  202 . The plunger  216  can be advanced toward the interior lumen  224  of the second section  208 . The plunger  216  can enter the interior lumen  224  of the second section  208 . In some methods, the plunger  216  can exit the slot in the second section  208  (not shown). The head  214  can abut the surface  220  when the plunger  216  reaches the slot in the second section  208 . The enlarged cross-section of the head  214  can prevent the head  214  from entering the slot  218 . In other techniques, the plunger  216  enters the slot in the second section  208  and exits the slot  218  of the first section  202 . 
       FIG.  34 F  show a cross-sectional view of the first section  202 . The slot  218  can be tapered in some embodiments. The interior lumen  222  can align with the interior lumen  224 . The interior lumens  222 ,  224  can be sized to accept the plunger  216 . The plunger  216  can be advanced until it protrudes from the interior lumen  222 . The plunger  216  can span the gap between the first tip  206  and the second tip  212 . In other embodiments, the plunger  216  extends from the interior lumen  222  directly into the interior lumen  224 . The plunger  216  can include a sharpened tip  228  to penetrate any tissue within the gap. The plunger  216  can bridge any potential gap between the first tip  206  and the second tip  212 . 
     In some techniques, the second tip  212  can engage the suture  106  carried by the plunger  216 . The second tip  212  can include a snare or other feature to engage the suture  106 . The second tip  212  can unload the suture  106  from the plunger  216  as the plunger  216  is retracted. In some techniques, the plunger  216  is retracted with the first tip  206 . 
     In some techniques, the second tip  212  engages the suture  106 . The plunger  216  could include a snare or other feature to engage the suture  106 . The plunger  216  can be advanced through the first tip  202  toward the suture  106 . The plunger  216  would engage the suture  106  from the second tip  212 . The plunger  216  can engage the suture  106  as the plunger  216  enters the interior lumen  224  of the second tip  212 . The plunger  216  can be retracted to pull the suture  106  through the first tip  206 . 
     It is contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments disclosed above may be made and still fall within one or more of the inventions. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with an embodiment can be used in all other embodiments set forth herein. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed inventions. Thus, it is intended that the scope of the present inventions herein disclosed should not be limited by the particular disclosed embodiments described above. Moreover, while the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as “passing a suture to suspend the hyoid bone” include “instructing the passing of a suture to suspend the hyoid bone.” The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “approximately”, “about”, and “substantially” as used herein include the recited numbers (e.g., about 10%=10%), and also represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount.