Methods and apparatus for treating glottic insufficiency

An example implant system to treat glottic insufficiency is disclosed. The implant system includes a fixation frame including a first set of flanges at a first edge of the fixation frame and a second flange at a second edge of the fixation frame, wherein the fixation frame is configured to secure the implant system at an opening of the patient's thyroid cartilage, a port system disposed in the fixation frame and configured to receive, deliver, maintain, or remove a filler, and a flexible member, coupled to the fixation frame and in fluid or air communication with the port system, wherein based on an amount of the filler in the flexible member, the flexible member is configured to inflate in a direction to push against the patient's arytenoid cartilage so the arytenoid cartilage is rocked, adducted and/or rotated inferomedially.

BACKGROUND

Dysphagia associated with aspiration pneumonia often occurs in patients with neurological disorders. The neurological disorders may be caused by stroke, brain surgery, head and/or spinal cord trauma, oropharyngeal diseases, radiation therapy, cardiac/thoracic surgery, autoimmune or other degenerative neurologic diseases. The aspiration pneumonia may be mainly caused by glottic insufficiency, due to vocal fold paralysis with or without swallowing dysfunction. Stroke patients with aspiration symptoms may have a seven-time higher risk in developing aspiration pneumonia than other types of patients. For these stroke patients, even after recovery, there is still a relatively high incidence of dysphagia associated with aspiration pneumonia.

Conventional surgical techniques to treat dysphagia and glottic insufficiency may include Type I Medialization Thyroplasty (MT) procedure and Arytenoid Adduction (AA) procedure. Type I MT procedure is the main phonosurgical procedure performed in patients with glottic insufficiency. The primary limitations of Type I MT procedure include the inability to close a wide posterior glottal chink and restore the physiological swallowing steps, like laryngeal elevation and vocal fold movement. For patients with vocal fold paralysis and a significant posterior glottic gap after the Type I MT procedure, an AA procedure may be performed subsequently to close the incompletely closed posterior glottis. Still, one limitation of the AA procedure, associated with the posterior airway closure, is an increased frequency of postoperative airway complaints after the AA procedure, due to postoperative tissue edema in the glottic area. Further, Type I MT and AA procedures may not be suitable for patients having difficulty with prolonged periods of supine positioning or intolerable for long lasting surgical procedures.

Since the above two procedures either use implants or suture fixation technique, a common complaint from these procedures is the inability to precisely adjust the implant or sutures intraoperatively and postoperatively. Specifically, it is difficult to accurately perform intraoperative adjustment of implant due to edematous swelling of laryngeal mucosa caused by these procedures. For example, carving an implant during surgery may result in prolonged operation time and suboptimal shaping of the implant. Furthermore, these implants cannot be postoperatively adjusted at all.

Providing an adjustable implant for the procedure would shorten the operation time, and reduce the risk of postoperative airway compromise. The size of the adjustable implant would be customized for each individual's needs, from which the patient could greatly benefit.

SUMMARY

In some embodiments of the present disclosure, an implant system to treat glottic insufficiency is disclosed. The implant system includes a fixation frame comprising a first set of flanges at a first edge of the fixation frame and a second flange at a second edge of the fixation frame, wherein the fixation frame is configured to secure the implant system at an opening of the patient's thyroid cartilage, a port system disposed in the fixation frame and configured to receive, deliver, maintain, or remove a filler, and a flexible member, coupled to the fixation frame and in fluid or air communication with the port system, wherein based on an amount of the filler in the flexible member, the flexible member is configured to inflate in a direction to push against the patient's arytenoid cartilage so the arytenoid cartilage is rocked, adducted and/or inferomedially rotated.

In some other embodiments of the present disclosure, a method to treat glottic insufficiency of a patient is disclosed. The method includes placing an implant system in an opening of the patient's thyroid cartilage, attaching a fixation plate and a fastener to a fixation frame of the implant system, wherein a thread goes through one or more holes of the fixation plate, securing the implant system on the thyroid cartilage with the fixation plate and the fastener, guiding an injector to a port system of the implant system, and injecting an amount of a filler to inflate a flexible member of the implant system so the flexible member pushes against the patient's arytenoid cartilage and rocks, adducts, and/or inferomedially rotates the patient's arytenoid cartilage.

DETAILED DESCRIPTION

The present disclosure describes apparatuses and methods to treat glottic insufficiency (due to neuromuscular incoordination or disordered interaction (cooperation) between the intrinsic muscles), and the poor closure of larynx inlet (opening) (due to uncoordinated bending of epiglottis and delayed or absence of laryngeal elevation). The disclosed treatments may improve the glottic closure and reduce the incidence of aspiration, thus preventing the aspiration's sequelae, such as aspiration pneumonia. Furthermore, the disclosed treatments may enable the postoperative adjustment of implants, and reduce the risk of postoperative airway compromise. As a result, the disclosed treatments may shorten the operation time during the surgical procedures. Perioperative complications, such as difficult intubation, can also be prevented through the implant adjustability. With a complete glottic closure, aspiration pneumonia can be effectively reduced or prevented after the surgical procedures.

In examples of the present disclosure, an implant system is designed to close the glottis by rocking, adducting, or inferomedially rotating the arytenoid cartilage. The amount of rock, adduction and/or inferomedially rotation is adjustable by changing the size of an implant, and the size of the implant can be changed by varying the amount of filler in the implant. The present disclosure may achieve the same effect as type I Medialization Thyroplasty (MT) and Arytenoid Adduction (AA), when performed together. Further, it may lengthen and tense the vocal fold by posterior expansion of the flexible member.

FIGS. 1A and 1Billustrate various views of larynx anatomy.

Drawing110shows the anatomy of a patient's larynx in an anterior view, with outer side111of the thyroid cartilage, or the thyroid cartilage lamina, exposed. Drawing120shows the same patient's larynx in a posterior view, with inner side121of the thyroid cartilage exposed. Drawing120further shows the patient's vocal ligament122, which are enclosed within the patient's vocal folds (not shown in the drawing120). Drawing130shows the same patient's laryngeal cartilages (including a cross-sectional view131of the thyroid cartilage) in an angled lateral view. In examples of the present disclosure, the space surrounded by the laryngeal cartilages, including but not limited to thyroid cartilage, corniculate cartilage, arytenoid cartilage, cricoid cartilage, posterior cartilage illustrated inFIGS. 1Aand1B, as well as the tissues and organs connected to these cartilages, may be deemed a “paraglottic space.” In other words, the paraglottic space may be a space bounded by the thyroid cartilage and the various surrounding membranes.

Drawing140illustrates an example healthy vocal fold having two lateralized vocal folds141and142. During normal breathing, swallowing, or speaking, vocal folds141and142open and close in unison. Before a person swallows food, the food or drink is first crushed and/or mixed into a pasty mass known as a bolus. During swallowing, the person's extrinsic and intrinsic muscles cooperate to prevent food or drink from entering the glottis. For example, the person's extrinsic muscles elevate the larynx and bend the epiglottis over the entrance to the glottis so that the bolus can glide across the epiglottis rather than falling into the larynx. While this movement is under way, the person's intrinsic muscles close the glottis. In conjunction withFIG. 1A, should any food particles or liquids pass through the vestibule or vocal folds141and142or come in contact with trachea143, a cough reflex may be automatically triggered in a healthy person to prevent the material from falling more caudally. However, this cough reflex is desensitized in patients with neurological disorder, such as stroke, making it more important to completely close the glottic gap.

Drawing150illustrates an example unhealthy vocal cord having a paralyzed vocal fold151unable to move to a fully lateralized/medialized position. In other words, paralyzed vocal fold151cannot be opened and closed in unison with the other vocal fold152, leaving an opening or gap in the glottis. Thus, during swallowing, the bolus may inadvertently slip into the glottis and subsequently into the trachea, bronchus, and lungs, which may lead to infection and pneumonia. Further, as shown in drawing160, for some of the stroke patients, due to impaired neurological stimulus, the trigger of epiglottis bending, the glottic closure161, and/or the laryngeal elevation162are delayed or absent, leading to incoordination of their extrinsic and intrinsic muscle movements. As a result, the patient may have difficulty in swallowing and may even choke as well.

To treat a patient's glottic insufficiency and/or swallowing difficulty, drawing170shows that a surgeon or medical machinery may utilize a surgical device to create cartilage opening172in the patient's thyroid cartilage171. The surgical device may perform certain functions such as drilling, shaping, space expansion (e.g., “dissection”), and instrument/implant delivery. Afterwards, the surgeon or the medical machinery places a conventional implant system through cartilage opening172into the paraglottic space behind the patient's thyroid cartilage171.

FIG. 2Aillustrates a top view of paraglottic space201in which implant system200can be placed to treat glottic insufficiency, in accordance with some embodiments of the present disclosure. The top of the figure corresponds to the anterior aspect of a patient's larynx, and the bottom of the figure corresponds to the posterior aspect of the patient's larynx. InFIG. 2A, opening203of thyroid cartilage210is created to access paraglottic space201surrounded by thyroid cartilage210and arytenoid cartilages221and222. Opening203and thyroid cartilage210may correspond to opening172and thyroid cartilage171ofFIG. 1C, respectively. Arytenoid cartilage221is coupled to healthy vocal fold231, and arytenoid cartilage222is coupled to paralyzed vocal fold232. Opening203may be created with a surgical device on the patient's thyroid cartilage lamina. The surgical device may perform certain functions such as, without limitation, drilling, shaping, and space expansion (e.g., dissection).

In conjunction withFIG. 2A,FIG. 2Billustrates an example implant system200to be placed in paraglottic space201through opening203, in accordance with some embodiments of the present disclosure. Implant system200includes fixation frame240, fixation block250, fastener260, port system270, and flexible member280. Implant system200may be secured to opening203with fixation frame240. Fixation frame240includes a first set of flanges241. Flanges241may be at a first edge of fixation frame240, and they are separated from each other by a distance corresponding to the thickness D of thyroid cartilage210to engage fixation frame240with opening203of thyroid cartilage210. This thickness D varies among patients. An example range of the thickness D is between 1 mm to 5 mm. Flanges241may or may not be substantially in parallel. Fixation frame240may include biocompatible materials, for example, titanium, peek, or silicone. In some other embodiments, fixation frame240may be elastic, so that it may be squeezed into and fit in various sizes of openings203of thyroid cartilage210. In addition, removing or reinstalling an elastic fixation frame240may be easier. Fixation frame240may further include a second flange243at a second edge of fixation frame240. Second flange243is configured to extend from the second edge of fixation frame240, away from the first edge adjacent to flanges241, to cover opening203of thyroid cartilage210.

In some embodiments, fixation block250may include flange257. Fixation block250may be secured with fixation frame240after fixation frame240is placed into opening203. In some embodiments, fastener260is placed in fixation block250and is used to secure fixation block250to fixation frame240. Fastener260is configured to secure with second flange243of fixation frame240. Flange257and second flange243may be configured with a separation distance corresponding to the thickness D of thyroid cartilage210after fixation block250is secured with second flange243of fixation frame240. In addition, fixation block250may have wings, extending in anterior, cranial and caudal directions, providing a better halt for fixation block250and preventing fixation block250from falling into paraglottic space201through opening203.

In conjunction withFIGS. 2A and 2B,FIG. 2Cillustrates implant system200secured at opening203of thyroid cartilage210and example approaches to rock, adduct, and/or inferomedially rotate arytenoid cartilage, in accordance with some embodiments of the present disclosure. In some embodiments, by turning fastener260, fastener260may protrude medially from second flange243with a distance D1and be physically in contact with flexible member280. As fastener260is turned further, fastener260may protrude further from second flange243, and the distance D1increases. D1may be less than 5 mm. In other embodiments, D1may be between 0 mm to about 4 mm. By pushing against flexible member280in a medial or medioposterior direction, the change in the position of flexible member280creates a physical contact between flexible member280and arytenoid cartilage222and initiates a clockwise rotation of arytenoid cartilage222. This rotation leads to arytenoid cartilage222being rocked, adducted, and/or inferomedially rotated, which results in having the paralyzed vocal fold232fixed in its median position.

In alternative embodiments, if vocal fold231is paralyzed, an implant system similar to implant system200may be placed from a right opening (not shown but from the same perspective ofFIG. 2C) of thyroid cartilage210to fix vocal fold231in its median position. A flexible member of the implant system may be pushed in medial or medioposterior direction, initiate a counterclockwise rotation of arytenoid cartilage221, lead to arytenoid cartilage221being adducted and rotated inferomedially to fix vocal fold231in its median position.

The head of fastener260may be circular, non-circular with multiple angles, star-shaped, or any shape to provide a sufficient halt between fastener260and surrounding material. Fastener260may be rotated with a screwdriver manually or may be rotated by electromagnetic force or remote control (e.g. Bluetooth) with an actuator integrated in implant system200.

In addition to using fastener260to adjust arytenoid cartilage222, arytenoid cartilage222may also be adjusted with the AA surgical procedure. In some embodiments, fixation frame240provides a fixation point for one or more sutures used in the AA surgical procedure. One example of this fixation point may be a fastener. Fixation frame240may define opening242. One or more sutures290can be inserted into opening242with one end291forming a loop to be in physical contact with the muscular process of the arytenoid cartilage222and/or lateral cricothyroid muscle and/or thyroarytenoid muscle to perform the AA surgical procedure. The other end of sutures290is secured on fastener261(e.g., screw) disposed adjacent to opening242. A surgeon may fasten fastener261to adjust the length and tension of sutures290. In response to the changes of the length and tension of sutures290, traction forces exerted on intrinsic laryngeal adductor muscles and/or arytenoid cartilage results in a rotation of arytenoid cartilage222, causing the change in the position in craniocaudal and/or mediolateral direction of a paralyzed vocal fold232.

In addition to using fastener260and the AA surgical procedure, flexible member280may also be used to adjust arytenoid cartilage222and paralyzed vocal fold232. In conjunction withFIGS. 2A and 2B, in some embodiments, port system270is an apparatus configured to receive, deliver, maintain, or remove a filler (e.g., saline solution) to inflate or deflate flexible member280. In some embodiments, port system270includes port membrane273, port chamber271, and flow channel272. Port system270may be disposed in fixation frame240. To access port system270, a healthcare professional may use an injector, such as injector295, in direction292to puncture port membrane273. The filler may be injected into port system270after injector295reaches port chamber271. In some embodiments, the filler may also be removed from port system270with injector295. Port membrane273is flexible and is configured to automatically seal itself after injector295is removed. By sealing itself, the filler can then be maintained in port system270and flexible member280. Port membrane273may be made of silicone or other biocompatible materials of various thicknesses (>2 mm).

Flexible member280is in fluid and/or air communication with the filler delivered, maintained, or removed through the port system270. In response to an increased pressure in port chamber271(e.g. when injector295is pushed), the filler flows into flexible member280, and flexible member280inflates. In response to a decreased pressure in port chamber271(e.g., when injector295is pulled), the filler leaves flexible member280, and flexible member280deflates. Flexible member280may have a shape that is suitable for introduction into paraglottic space201. The shape and size of flexible member280may be adjustable by adding/removing filler to/from flexible member280via port system270during operation (intraoperatively). After the operation (postoperatively), in response to possible compromises, such as airway compromises, intubation difficulties, and others, the size of flexible member280may be readjusted to prevent the occurrences of complications.

FIG. 2Dillustrates an example embodiment of flexible member280of implant system200to treat glottic insufficiency, in accordance with some embodiments of the present disclosure. In conjunction withFIG. 2C, in some embodiments, flexible member280includes anterior member281and posterior member283. Anterior member281is in fluid and/or air communication with fillers maintained in first port chamber276of port system270, and posterior member283is in fluid and/or air communication with fillers maintained in second port chamber275of port system270. First port chamber276and second port chamber275are separated by pressure valve277. Pressure valve277is configured to allow fillers to flow between first port chamber276and second port chamber275under a predetermined pressure. Inflations of anterior member281and posterior member283are controlled by the amount of fillers maintained in first chamber276and second chamber275, respectively. Inflation of anterior member281may cause flexible member280to push paralyzed vocal fold232back to a median position. Inflation of posterior member283may cause flexible member280to push against arytenoid cartilage222. The continued inflate of posterior member283would cause the adduction, rocking, and/or inferomedial rotation of arytenoid cartilage222. Posterior member283may include a posterior-medial tip285, which has a distance D2of about 4 mm to about 15 mm measured perpendicularly from the medial side of the thyroid cartilage210. Flexible member280is made of biocompatible materials, such as silicon or biodegradable materials. To support a designated expansion direction, flexible member280may be composed of a wall of varied stiffness (e.g., ≥20 Shore) and/or thickness (e.g., ≥2 mm).

FIG. 2Eillustrates example configurations of flow channel279of port system270disposed between port chamber271and posterior member283of flexible member280, in accordance with some embodiments of the present disclosure. In conjunction withFIG. 2D, flexible member280may include posterior member283but not anterior member281.

As illustrated, fixation frame240may have different configurations, and posterior member283is in fluid and/or air communication with port chamber271via flow channel279. To prevent an injector configured to inject fillers into port system270from inadvertently puncturing flexible member280via flow channel279, in some embodiments, as shown in the top two figures ofFIG. 2E, flow channel279is disposed in manners such that its entry272cannot be directly accessed by the injector. For example, entry272may be disposed adjacent to one end of port chamber271.

In an alternative embodiment, as shown in the bottom figure ofFIG. 2E, fixation frame240includes rigid plate structure274extended from one side of port chamber271, which is placed near entry272, to prevent the injector from directly accessing entry272.

In conjunction withFIG. 2A,FIG. 3Aillustrates a top view of an example implant system300secured at thyroid cartilage210to treat glottic insufficiency, in accordance with some embodiments of the present disclosure. In contrast to implant system200illustrated inFIGS. 2B-2D, injector395is configured to deliver a filler to posterior member383of flexible member380in direction392, causing posterior383to inflate approximately along direction385(e.g., inflate along the posterior-medial direction). Inserting injector395into implant system300in direction392, as opposed to direction292shown inFIG. 2C, allows a healthcare professional to more easily and precisely access port system administer. As posterior member383inflates, it eventually comes into physical contact with arytenoid cartilage222and pushes against arytenoid cartilage222to initiate clockwise rotation387of arytenoid cartilage222. While flexible member380and posterior member383may come in different shapes, they are configured to inflate in a particular manner, such as in a designated expansion direction (e.g., direction385). As discussed earlier, the wall of a flexible member may be varied in stiffness and/or thickness to support a designated expansion direction. In other words, instead of inflating posterior member383and flexible member380uniformly in all directions, the wall of flexible member380may be less stiff/thinner in the proximity of arytenoid cartilage222but more stiff/thicker elsewhere, so that posterior member383and flexible member380mainly inflate in direction385as the filler continues to be delivered.

Additional details of implant system300are illustrated inFIGS. 3B-3Eand described in the paragraphs below.

FIG. 3Billustrates an enlarged view of an example implant system300configured to treat glottic insufficiency, in accordance with some embodiments of the present disclosure. Implant system300includes, but not limited to, thread310, fixation frame320, fixation plate330, screw340, port system350(shown in at leastFIGS. 3D and 3E), and flexible member380.

In some embodiments, screw340is integrated with fixation plate330. Fixation plate330may include holes so that thread310can go through them. One end of thread310may be attached to base325of fixation frame320. Before screw340is fully engaged with base325and secures fixation plate330with base325, fixation plate330with the integrated screw340may move along thread310. With this illustrated configuration, thread310may help to ensure keeping fixation plate330, screw340, and fixation frame320together, especially during operation. Thread310may be removed after implant system300is secured at thyroid cartilage210.

Fixation frame320is configured to secure implant system300at thyroid cartilage210. Fixation frame320includes a first set of flanges321and321′. Similar to flanges241shown inFIG. 2B, flanges321and321′ may be at a first edge of fixation frame320and separated from each other with a distance corresponding to the thickness D of thyroid cartilage210. Flanges321and321′ may or may not be substantially in parallel. Fixation frame320may include biocompatible materials, for example, titanium, peek, or silicone. Fixation frame320may further include a second flange323at a second edge of fixation frame320. Second flange323is configured to extend from the second edge of fixation frame320to cover opening203of thyroid cartilage210.

In some embodiments, screw340may protrude in direction360, or medially, from second flange323with a certain distance and be physically in contact with flexible member380. As screw340protrudes further from second flange323, the distance of protrusion (not shown, but similar to D1ofFIG. 2C) increases. In some embodiments, the protrusion distance may be less than 5 mm. In other embodiments, the protrusion distance may be between 0 mm to about 4 mm. By pushing against flexible member380in medial or medioposterior direction, the change in the position of flexible member380creates a physical contact between flexible member380and arytenoid cartilage222and initiates a clockwise rotation of arytenoid cartilage222. Similar to fastener260ofFIG. 2C, this rotation leads to arytenoid cartilage222being rocked, adducted and/or rotated inferomedially, which results in having the paralyzed vocal fold232fixed in its median position.

FIG. 3Cillustrates a perspective view of an example implant system300configured to treat glottic insufficiency, in accordance with some embodiments of the present disclosure. In conjunction withFIGS. 3A and 3B, in some embodiments, fixation frame320further includes a pair of side arms322and anterior shovel324. Anterior shovel324may protrude anteriorly from port membrane353, and anterior shovel324may also be substantially perpendicular with any of side arms322. Anterior shovel324is disposed on one side of flange321′ at an angle substantially greater than 90 degrees. Anterior shovel324may be configured to guide injector395to reach port membrane353of port system350. In some instances, anterior shovel324may also prevent injector395from puncturing the anterior aspect of a patient's larynx.

Side arms322help to define a boundary around port membrane353of port system350. As injector395ofFIG. 3Aapproaches port system350, injector395may hit side arms322, and the physical impact with side arms322may guide a surgeon to locate port membrane353. Alternatively, side arms322may act as a visual guide for a surgeon to locate port system350, because side arms322are visible as bright hyperechoic lines in ultrasound images. In some embodiments, the thickness of side arms322is between about 0.5 mm to about 2 mm.

FIG. 3Dillustrates a cross sectional view of an example implant system300, in accordance with some embodiments of the present disclosure. In conjunction withFIGS. 3A, 3B, and 3C, in some embodiments, port system350is an apparatus configured to receive, deliver, maintain, or remove one or more fillers to inflate, maintain or deflate posterior member383of flexible member380. Port system350may be disposed in fixation frame320and may be adjacent to base325. In some embodiments, port system350includes port membrane353, port chamber355, and flow channel357. As injector395continues to move in direction392, the needle of injector395may puncture port membrane353and move into port chamber355. With the needle in port chamber355, injector395may then inject fillers into port chamber355. Posterior member383is in fluid and/or air communication with port chamber355via flow channel357. In some embodiments, flow channel357is disposed in manners such that its entry359cannot be directly accessed by the needle of injector395. For example, entry359may be disposed adjacent to one end of port chamber355to prevent injector395from inadvertently puncturing flexible member380via flow channel357. The interior wall of port system350may have an undulated surface to prevent sliding of port membrane353when injector395is inserted into or removed from the port system350.

Injector395is also visible as a bright hyperechoic line in response to injector395being inserted in the same plane as the ultrasound beam of the ultrasound scanner. The alignment of injector395and the ultrasound beam may be achieved by a mechanical guide attached to a probe of the ultrasound scanner. In some embodiments, a surface treatment is applied on the injector to increase the ultrasonic visualization. In some other embodiments, injector395may be an echogenic ultrasound needle. The echogenic ultrasound needle may include a polymer coating, which holds microbubbles and a dimpled shaft.

FIG. 3Eillustrates an injection angle for an example implant system300configured to treat glottic insufficiency, in accordance with some embodiments of the present disclosure. Port membrane353of the port system350and surface327of fixation frame320may define an injection angle329for injector395to inject one or more fillers into the port system350. In some embodiments, injection angle329is about 0 degree to about 90 degrees. More specifically, injection angle329may be about 30 degrees to about 60 degrees (e.g., about 45 degrees). Orientation of the port membrane353and/or the port system350may be altered to adjust injection angle329. In some embodiments, port membrane353and/or the port system350may be oriented uniaxially, biaxially, or triaxially to achieve a proper injection angle329.

FIG. 4illustrates a flow chart of an example process400to treat glottic insufficiency with an example implant system300, in accordance with some embodiments of the present disclosure. In conjunction withFIGS. 3A, 3B, 3C, and 3D, example process400may include one or more operations, functions, or actions illustrated by one or more blocks, such as402to410. The various blocks may be combined into fewer blocks, divided into additional blocks, and/or eliminated depending on the desired implementation.

Example process400may begin in block402. In block402, implant system300is placed in an opening203on a patient's thyroid cartilage210. As shown inFIG. 3A, flanges321and321′ are separated from each other with a distance corresponding to the thickness D of the thyroid cartilage so that flanges321and321′ are able to engage with the thyroid cartilage. Block402may be followed by block404.

In block404, fixation plate330and screw340are attached to fixation frame320. In some embodiments, screw340is integrated with fixation plate330. As discussed earlier, one end of thread310goes through one or more holes defined by fixation plate330. The other end of thread310is attached to base325of fixation frame320. Block404may be followed by block406.

In block406, implant system300is secured on thyroid cartilage. One securing mechanism is to fasten screw340to lock fixation plate330to base325. In some embodiments, screw340may be fastened until the distance between fixation plate330and flange323substantially corresponds to the thickness D of the thyroid cartilage. In other embodiments, screw340may be turned further, so that screw340protrudes from base325and pushes against flexible member380in a medial or medioposterior direction. Block406may be followed by block408.

In block408, injector395is guided to port system350. In some embodiments, side arms322are identified with ultrasonic waves to determine a boundary around the port system350. Injector395may be also identified with ultrasonic waves to adjust the path of injector395to approach the port membrane353of the port system350according to identified side arms322. In some embodiments, injector395is used to inject a filler into the port chamber355through the port membrane353of the port system350. Port chamber355is in fluid/air communication with posterior member383of flexible member380via flow channel381. In some embodiments, due to the injection angle of injector395, injector395may come in physical contact with side arms322and/or anterior shovel324. The feedback from the physical contact may cause a surgeon to adjust how injector395should be inserted and help to guide injector395to port membrane353. Block408may be followed by block410.

In block410, certain amount of filler is injected by injector395so that the patient's arytenoid cartilage can be rocked, adducted, and/or rotated inferomedially. In some embodiments, posterior member383of flexible member380is adjusted based on the amount of the filler injected by injector395. Posterior member383may inflate in response to an increased amount of the injected filler. Similarly, posterior member383may deflate in response to a decreased amount of the injected filler. The inflation and deflation of posterior member383may adduct and inferomedially rotate the arytenoid cartilage to place paralyzed vocal fold to a median position.