Patent ID: 12220311

DETAILED DESCRIPTION

The presently disclosed subject matter now will be described more fully hereinafter with reference to the accompanying Figures, in which some, but not all embodiments of the presently disclosed subject matter are shown. Like numbers refer to like elements throughout. The presently disclosed subject matter may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Indeed, many modifications and other embodiments of the presently disclosed subject matter set forth herein will come to mind to one skilled in the art to which the presently disclosed subject matter pertains having the benefit of the teachings presented in the foregoing descriptions and the associated Figures. Therefore, it is to be understood that the presently disclosed subject matter is not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims.

I. Minimally Invasive Magnetic Vocal Fold Manipulator

Vocal fold immobility, including vocal fold paralysis, is a broad term that can be used to describe an abnormal, reduced, or restricted movement of the vocal folds, i.e., the true vocal folds, also referred to herein as the vocal cords, wherein the terms are used interchangeably. Vocal fold immobility can be unilateral, in which only one vocal fold is affected, or bilateral, in which both vocal folds are affected. The abnormal movement of the vocal folds can be paretic, i.e., where some movement is present, but impaired, or paralyzed, which includes complete cessation of vocal fold movement.

Vocal fold paralysis occurs when the nerve impulses to a subject's larynx are disrupted. Possible causes of vocal fold paralysis include nerve damage encountered during surgery, including surgeries to the thyroid or parathyroid glands, esophagus, neck, and chest; neck or chest injury; stroke; cancerous or noncancerous tumors; infections, including Lyme disease, Epstein-Barr virus and herpes; and certain neurological conditions, such as multiple sclerosis or Parkinson's disease. Symptoms of vocal fold paralysis include, but are not limited to, a breathy quality to the voice; hoarseness; noisy breathing; loss of vocal pitch; choking or coughing while swallowing food, drink or saliva; the need to take frequent breaths while speaking: inability to speak loudly; loss of gag reflex; ineffective coughing; and frequent throat clearing. Treatment for vocal fold paralysis can include surgery.

In some embodiments, the presently disclosed subject matter provides a minimally invasive magnetic vocal fold manipulator system and method. More particularly, the presently disclosed subject matter provides a magnetic vocal fold manipulator system that includes a magnetics-based thyroid cartilage implant that is used in combination with a magnetics-based arytenoid cartilage implant to produce varying extents of both lateralization and medialization of the vocal fold as needed.

Importantly, the presently disclosed system is implantable, reversible, and fully adjustable. Others, see, for example, U.S. Pat. No. 5,593,439 for Vocal Cord Lateralization and Medialization Device and Method, to Cummings et al., issued Jan. 14, 1997, which is incorporated herein by reference in its entirety, have described methods of vocal fold lateralization, which are not easily reversible and create the possibility of post-operative complications including fistula formation, e.g., an abnormal connection between two body parts. No devices known in the art have provided a fully reversible, or fully adjustable method of achieving vocal fold lateralization while creating minimal stress on native tissue.

In contrast, the presently disclosed subject matter provides a multi-component device and method for manipulating, including lateralization and medialization, the vocal cord(s) in a subject afflicted with permanent vocal fold paralysis, wherein the device is fully adjustable, fully reversible, and greatly reduces the amount of tissue stress at the cricoarytenoid joint. By being fully adjustable, the presently disclosed device allows the final position of the vocal cord to be modified to enhance or maximize the quality of the subject's voice, e.g., tuned to the proper level of phonation, and airway patency following the procedure. Moreover, the presently disclosed device also allows for medialization, an additional functionality useful in management of unilateral vocal fold paralysis where voice outcomes are usually the primary concern.

More particularly, the presently disclosed device and method for vocal fold lateralization (primary function) or medialization (secondary function) of the vocal fold manipulates position of the ipsilateral arytenoid process. Unlike other vocal fold lateralization devices known in the art, the presently disclosed device engages the arytenoid via a magnetic implant to pull (lateralization) or push (medialization) the cartilage or soft tissue of the vocal fold.

As used herein, the term “lateralization,” and grammatical variations thereof, refers to a procedure in which a vocal fold, or the arytenoid cartilage to which the vocal fold is attached, is moved laterally to open the airway of a subject.

As used herein, the term “medialization,” and grammatical variations thereof, refers to a procedure in which a vocal fold is moved or positioned toward the middle of the airway, i.e., toward a midline of the larynx, so that the functioning vocal fold can close as necessary for normal voice and swallowing function.

Accordingly, in some embodiments, the magnetics-based thyroid cartilage implant is a magnetic thyroid cartilage implant that includes a magnet and the magnetics-based arytenoid cartilage implant is an implantable magnetized or magnetizable arytenoid locking screw formed of magnetically responsive material. As a result, the presently disclosed system creates an adjustable and easily reversible system that minimizes the destruction/disruption of native soft tissue, thereby minimizing the possibility of post-operative complications.

In some embodiments, as is provided in more detail herein below, an implantable magnetic device is introduced into the arytenoid cartilage of the subject, independent of a magnetic piston that is fixated to the thyroid cartilage of the subject. A custom needle tip found on this magnetic implant is a unique design that provides a fully reversible locking mechanism. The amount of tissue stress created by the presently disclosed implant is significantly less than larger screw systems, which provide permanent mechanical fixation to the external thyroid cartilage components.

Referring now toFIG.1is a block diagram of an example of the presently disclosed magnetic vocal fold manipulator system100that includes a magnetics-based thyroid cartilage implant110and a magnetics-based arytenoid cartilage implant120. Magnetics-based thyroid cartilage implant110is designed for implanting in or otherwise affixed to the thyroid cartilage of a subject. The thyroid cartilage comprises the bulk of the front wall of the larynx and protects the vocal folds, i.e., the vocal cords, which are located directly behind it. Magnetics-based arytenoid cartilage implant120is designed for implanting in or otherwise affixed to the arytenoid cartilage of a subject. The arytenoid cartilages are paired cartilages that form a part of the larynx to which the vocal folds are attached. The arytenoid cartilages influence the position and tension of the vocal folds, which allows and facilitates vocal fold movement. The arytenoid cartilages are located at the posterosuperior border of the cricoid cartilage of the larynx.

One feature of magnetic vocal fold manipulator system100is that the main interaction between magnetics-based thyroid cartilage implant110and magnetics-based arytenoid cartilage implant120is by magnetic force. In one example, magnetics-based thyroid cartilage implant110includes a magnet and magnetics-based arytenoid cartilage implant120is formed of a magnetically responsive material. Accordingly, magnetic force is used to pull magnetics-based arytenoid cartilage implant120that is implanted in the arytenoid cartilage toward magnetics-based thyroid cartilage implant110that is implanted in the thyroid cartilage. In so doing, the arytenoid cartilage, which is mechanically fixated to magnetics-based arytenoid cartilage implant120, then lateralizes to provide airway patency. More details of a representative, non-limiting example of magnetics-based thyroid cartilage implant110are shown and described herein below with reference toFIG.2,FIG.3, andFIG.4. More details of a representative, non-limiting example of magnetics-based arytenoid cartilage implant120are shown and described herein below with reference toFIG.5,FIG.6, andFIG.7.

Because the interaction between magnetics-based thyroid cartilage implant110and magnetics-based arytenoid cartilage implant120is by magnetic force and not mechanical coupling, the amount of tissue stress created by these implants is significantly less than conventional larger screw systems that provide permanent mechanical fixation to the external thyroid cartilage components. Namely, in magnetic vocal fold manipulator system100, the line of action of the magnetic force can act across soft tissue without disrupting its integrity and reducing the risk of potential fistula formation.

Magnetic vocal fold manipulator system100also includes an implant introducer device130. Implant introducer device130is any instrument for introducing and/or manipulating magnetics-based thyroid cartilage implant110and/or magnetics-based arytenoid cartilage implant120during the vocal fold manipulation procedure. More details of an example of implant introducer device130are shown and described herein below with reference toFIG.8andFIG.24.

Referring now toFIG.2,FIG.3, andFIG.4is an exploded side view, an exploded perspective view, and a perspective view, respectively, of a magnetic thyroid cartilage implant200, which is an example of the magnetics-based thyroid cartilage implant110shown inFIG.1. Additionally,FIG.4shows magnetic thyroid cartilage implant200when assembled and as it would lie within the thyroid cartilage.

Referring now toFIG.2, magnetic thyroid cartilage implant200includes, for example, a magnet210installed, housed, or otherwise enclosed in a hollow tubular body220, e.g., an external casing. Magnet210can be a permanent magnet or an electromagnet. In particular embodiments, magnet210comprises a neodymium magnet. In more particular embodiments, magnet210comprises an alloy of neodymium, iron, and boron. In yet more particular embodiments, magnet210comprises a Nd2Fe14B tetragonal crystalline structure. In other embodiments, the magnet210comprises a magnetic material selected from the group consisting of SmCo5, Sm (Co, Cu, Zr)7, AlNiCo, and Sr-ferrite. Regarding embodiments wherein magnet210comprises an electromagnet, specific embodiments include, but are not limited to, ferromagnetic centers wound with a solenoid wire. These include systems that may be driven by either direct or alternating currents.

Body220is a hollow tubular body that has a slotted end222and a non-slotted end224. Together, magnet210and body220form the magnetic component of magnetic thyroid cartilage implant200(i.e., the thyroid cartilage implant) that will interact with magnetics-based arytenoid cartilage implant120(e.g., the example shownFIG.5,FIG.6, andFIG.7).FIG.17illustrates a side view and a perspective view showing more details of body220of magnetic thyroid cartilage implant200, which is a non-threaded body. In one example, body220has an overall length L of between about 10 mm and about 20 mm, including 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, and 20 mm, and in particular embodiments has a length of about 15.3 mm, and an outside diameter (OD) of between about 2 mm and about 6 mm, including 2, 3, 4, 5, and 6 mm, and in particular embodiments has an OD of about 4.1 mm.FIG.18illustrates a side view and a perspective view of another example of body220of magnetic thyroid cartilage implant200. In this example, body220is a threaded body. For example, non-slotted end224has threads225thereon. Threads225may engage with corresponding threads (not shown) of translational bushing230. Body220can be comprised of any inert non-magnetic medical grade material that includes, but is not limited to, cobalt-chrome, stainless steel, titanium, or medical grade polymers and silicone with suitable stiffness.

Referring once again toFIG.2andFIG.3, body220is seated within a translational bushing230. Translational bushing230is a hollow tubular bushing that has a slotted end232and a threaded end234. In some embodiments, threaded end234of translational bushing230comprises male threads.FIG.19illustrates a side view and a perspective view showing more details of translational bushing230of magnetic thyroid cartilage implant200. In one example, translational bushing230has an overall length L of between about 5 mm to about 10 mm, including 5, 6, 7, 8, 9, and 10 mm, and in particular embodiments has as length of about 7.3 mm, and an outside diameter (OD) of between about 2.5 to about 8.5 mm, including 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, and 8.5 mm, and in particular embodiments has an OD of 5.5 mm. Translational bushing230can be made from any suitable material. In some embodiments, translational bushing230comprises a material selected from the group consisting of cobalt-chrome, stainless steel, and titanium. Other suitable materials include inert medical grade polymers and silicone with suitable stiffness.

Threaded end234of translational bushing230is screwed into or otherwise mated with an anchoring flange240. Anchoring flange240is a hollow tubular flange that has threads242on the inside, i.e., on an inner surface thereof, of the flange (seeFIG.3). In some embodiments, threads242on the inside of anchoring flange240comprise female threads. In such embodiments, the female threads of anchoring flange240are mated with the male threads of translational bushing230. There is a rim244near and around the end of anchoring flange240that receives translational bushing230. There is a rim246near and around the end of anchoring flange240farthest from translational bushing230.FIG.20illustrates a side view and a perspective view showing more details of anchoring flange240of magnetic thyroid cartilage implant200. In one example, anchoring flange240has an overall length L of between about 3 to about 10 mm, including 3, 4, 5, 6, 7, 8, 9, and 10, and in particular embodiments has a length of about 6.3 mm, Further, the main body of anchoring flange240has an outside diameter (OD) of between about 5 mm to about 10 mm, including 5, 6, 7, 8, 9, and 10 mm, and in particular embodiments has an OD of about 8 mm. Body220, translational bushing230, and anchoring flange240can be formed, for example, of cobalt-chrome (CoCr), stainless steel, titanium (Ti), medical grade plastic, medical grade silicone, and the like. In particular embodiments, anchoring flange240comprises a polyethylene material, for example, ultrahigh molecular weight polyethylene (UHMWPE). In other embodiments, anchoring flange240may be comprised of appropriately stiff medical grade silicone.

When in use, anchoring flange240is fastened into an iatrogenic hole, e.g., a hole that can be created by a surgeon or other medical personnel, which is introduced on the lateral aspect of the thyroid cartilage of the subject. Because translational bushing230is threaded, adjustments within anchoring flange240can be made to alter the relative depth of translational bushing230within anchoring flange240. This feature allows the depth or position of magnet210to be altered within magnetic thyroid cartilage implant200and, when in use, in relation to magnetized or magnetizable arytenoid locking screw300. Referring now again toFIG.4, note that, in some embodiments, the slot of slotted end222of body220is aligned with the slot of slotted end232of translational bushing230so that both can be engaged with, for example, a screwdriver blade at one time and rotated together.

Referring now toFIG.5,FIG.6, andFIG.7is a perspective view, a side view, and a front view, respectively, of an implantable magnetized arytenoid locking screw300, which is an example of the magnetics-based arytenoid cartilage implant120shown inFIG.1. Magnetized arytenoid locking screw300is an implantable locking screw. Magnetized arytenoid locking screw300includes a shaft310, a beveled and hollowed tip312mounted on one end of shaft310, and a slotted flange314on the opposite end of shaft310. In one example and referring now toFIG.6, magnetized arytenoid locking screw300has an overall length L of between about 8 mm to about 16 mm, including 8, 9, 10, 11, 12, 13, 14, 15, and 16 mm, and in particular embodiments has a length of about 12.5 mm, and an outside diameter (OD) of between about 2 mm to about 8 mm, including 2, 3, 4, 5, 6, 7, and 8 mm, and in particular embodiments has an OD of about 4.9 mm.

Tip312of magnetized arytenoid locking screw300is a unique design (i.e., beveled and hollowed) that provides a fully reversible locking mechanism. For example, tip312allows for mechanical fixation of the implantable magnetized arytenoid locking screw300within cartilaginous tissue by rotating it about 90 degrees in one direction (e.g., counterclockwise (CCW), the hollow opening rotating toward or into the tissue). Similarly, magnetized arytenoid locking screw300can be unlocked by rotating it about 90 degrees in the reverse direction (e.g., clockwise (CW), the hollow opening rotating away from or out of the tissue).FIG.21illustrates a perspective view, a side view, and an end view showing more details of the tip portion (e.g., tip312) of arytenoid locking screw300shown inFIG.5,FIG.6, andFIG.7.FIG.22illustrates a perspective view and a side view showing more details of the slotted flange portion (e.g., slotted flange314) of arytenoid locking screw300shown inFIG.5,FIG.6, andFIG.7.FIG.23illustrates perspective views and a side view of another example of arytenoid locking screw300. In this example, tip312is a conical smooth tip. Further, threads315are provided around shaft310of this example of arytenoid locking screw300.

The implantable magnetized arytenoid locking screw300can be inserted into or otherwise affixed onto the arytenoid cartilage via a translaryngeal or transcervical approach using conventional microlaryngeal techniques known in the art. It is embedded into the ipsilateral arytenoid cartilage underneath its overlying mucosal lining. Rather than spanning a full 360 degrees, tip312of magnetized arytenoid locking screw300consists of two 90-degree sections that can be found on complementary sides as shown inFIG.7.FIG.6shows the hollow nature of tip312, which enables magnetized arytenoid locking screw300to mechanically grasp soft tissue by turning about 90 degrees after being inserted. This unique design of magnetized arytenoid locking screw300also allows for a fully reversible mechanical fixation. For example, by rotating magnetized arytenoid locking screw300in the opposite direction by about 90 degrees, the soft tissue is no longer encased in the hollow tip312and the entire component can be removed.

The main interaction between magnetic thyroid cartilage implant200and magnetized arytenoid locking screw300is through magnet210and the magnetized arytenoid locking screw300itself. As the locking screw300itself is magnetized (either through the magnetic nature of its material or the incorporation of a smaller magnet into screw300, for example, in shaft310), the magnetic force of magnet210pulls magnetized arytenoid locking screw300toward magnetic thyroid cartilage implant200. In so doing, the arytenoid cartilage, which is mechanically fixated to magnetized arytenoid locking screw300, then lateralizes to provide airway patency.

The strength of the magnetic force between magnetic thyroid cartilage implant200and magnetized arytenoid locking screw300is adjustable by adjusting the physical distance between magnet210of magnetic thyroid cartilage implant200and magnetized arytenoid locking screw300. Namely, the magnetic force can be altered by adjusting the depth at which magnet210is placed within anchoring flange240of magnetic thyroid cartilage implant200. Translational bushing230is externally threaded (e.g., threaded end234) and can therefore move axially relative to anchoring flange240(which has internal threads242). This axial translation provides the user the ability to adjust how closely magnet210is positioned with respect to slotted flange314of magnetized arytenoid locking screw300and as a result directly affect the magnetic force at magnetized arytenoid locking screw300. This magnetic force is inversely proportional to the square of the distance between magnet210and the magnetized surface of magnetized arytenoid locking screw300. This relationship allows small adjustments in distance to create a meaningful change in magnetic force. The amount of lateralization also is being affected by this same mechanism. More details of a method of using magnetic thyroid cartilage implant200and magnetized arytenoid locking screw300are described herein below with reference toFIG.9throughFIG.16.

Referring now toFIG.8is a side view of a vocal fold lateralization device introducer400, which is an example of the implant introducer device130shown inFIG.1. Vocal fold lateralization device introducer400can be used when implanting magnetic thyroid cartilage implant200and/or magnetized arytenoid locking screw300. For example, vocal fold lateralization device introducer400is used to stabilize the operator's hand while implanting magnetic thyroid cartilage implant200into thyroid cartilage and/or implanting magnetized arytenoid locking screw300into arytenoid cartilage. Namely, vocal fold lateralization device introducer400is a custom instrument that is designed to assist in the manipulation of magnetized arytenoid locking screw300.

Referring now toFIG.24is a perspective view and a side view of another example of vocal cord lateralization device introducer400. Again, vocal cord lateralization device introducer400includes handle grip410that is operatively coupled to elongated hollow chamber412. Additionally, a slot413is provided at the tip of elongated hollow chamber412.

Vocal fold lateralization device introducer400includes a handle grip410that is operatively coupled to an elongated hollow chamber412that houses a custom screwdriver414and magnetized or magnetizable arytenoid locking screw300.

The manipulation of all the aforementioned components of magnetic thyroid cartilage implant200and/or magnetized arytenoid locking screw300can be achieved through use of custom screwdrivers. Namely, elongated hollow chamber412houses custom screwdriver414and magnetized arytenoid locking screw300as it is passed via a translaryngeal or transcervical approach to engage the underlying cartilage. Additionally, using vocal fold lateralization device introducer400, magnetic thyroid cartilage implant200can be adjusted by engaging slotted end222of body220through the use of a slot head custom screwdriver414. Additionally, magnetized arytenoid locking screw300and/or translational bushing230of magnetic thyroid cartilage implant200can be adjusted using custom screwdriver414, either a flattened Phillips head (FIG.25) or slot head (FIG.26).

Referring now toFIG.25is a side view and a perspective view of an example of custom screwdriver414for use with vocal cord lateralization device introducer400. In this example, the tip includes a cross blade configuration. Referring now toFIG.26is a side view and a perspective view of another an example of custom screwdriver414for use with vocal cord lateralization device introducer400. In this example, the tip includes a single blade configuration. Referring now toFIG.27is a side view and a perspective view of an example of a custom puncture tool900for use with vocal cord lateralization device introducer400. Custom puncture tool900will serve to create a pilot hole for the introduction of arytenoid screw300into the appropriate location, allowing easier engagement of the locking mechanism and screw head.

Again, because the interaction between magnetic thyroid cartilage implant200and magnetized arytenoid locking screw300is by magnetic force and not mechanical coupling, the amount of tissue stress created by these implants is significantly less than conventional larger screw systems that provide permanent mechanical fixation to the external thyroid cartilage components. Namely, in magnetic vocal fold manipulator system100, the line of action of the magnetic force can act across soft tissue without disrupting its integrity and reducing the risk of potential fistula formation.

In some embodiments, the presently disclosed subject matter provides a kit for manipulating a position of a vocal fold, comprising the thyroid cartilage implant and the magnetics-based arytenoid cartilage implant described hereinabove. In certain embodiments, the kit further comprises an implant introducer device. In more certain embodiments, the kit further comprises one or more components selected from one or more custom screwdrivers, a custom puncture tool, and instructions for use. The kit can further comprise sterile packaging.

Referring now toFIG.9is a flow diagram of an example of a method500of using the presently disclosed magnetic vocal fold manipulator system100to perform lateralization and/or medialization of the vocal cord. Namely, method500describes a process of implanting the magnetic thyroid cartilage implant200and the magnetized arytenoid locking screw300. Additionally, the entire process of method500is performed under direct visualization to confirm placement of the magnetic thyroid cartilage implant200and/or magnetized arytenoid locking screw300. For example, visualization can be via translaryngeal endoscopy. Further,FIG.10throughFIG.16may be referenced in the steps of method500. Method500may include, but is not limited to, the following steps.

At a step510, magnetized arytenoid locking screw300is introduced into the arytenoid cartilage via a translaryngeal or transcervical approach. For example and referring now toFIG.10, a front view is provided of a subject600of a vocal fold manipulation procedure.FIG.10shows an example of an incision610in the neck of subject600through which the procedure can be performed. Using a microscope and conventional microlaryngeal techniques, a small mucosal flap is raised over the ipsilateral arytenoid complex. In some embodiments, the arytenoid screw may be implanted into the arytenoid cartilage via a transcervical approach. In such embodiments, a transcervically accessed hole through the thyroid cartilage is enlarged to directly place the arytenoid screw into the underlying arytenoid cartilage. In this fashion, the arytenoid screw will remain submucosal during its implantation as it does not penetrate the endoluminal aspect of the mucosa. In certain embodiments, confirmation for placement of this arytenoid screw is performed through direct visualization of the glottis from above using an operating laryngoscope and operating microscope.

Next, vocal fold lateralization device introducer400and custom screwdriver414shown inFIG.8may be used to manipulate magnetized arytenoid locking screw300and fix it into the cartilage. For example, elongated hollow chamber412houses the custom screwdriver414and magnetized arytenoid locking screw300as it is passed via a translaryngeal approach to engage the underlying cartilage.

At a step512, magnetized arytenoid locking screw300is rotated by about 90 degrees to mechanically fix it within the arytenoid cartilage. Next, vocal fold lateralization device introducer400and custom screwdriver414is removed. Example views of magnetized arytenoid locking screw300implanted in the arytenoid cartilage are shown inFIG.11andFIG.12. Namely,FIG.11andFIG.12show vocal anatomy700that includes thyroid cartilage710and arytenoid cartilage715and wherein magnetized arytenoid locking screw300is implanted in arytenoid cartilage715.

At a step514, after placement of the magnetized arytenoid locking screw300has been visually confirmed, magnetic thyroid cartilage implant200is introduced into the iatrogenic opening of the thyroid cartilage. For example, anchoring flange240of magnetic thyroid cartilage implant200is mechanically fixed into an iatrogenic opening720of the thyroid cartilage710as shown inFIG.13. Rim244and rim246of anchoring flange240assist in holding magnetic thyroid cartilage implant200securely in the thyroid cartilage710as shown inFIG.14.

At a step516, translational bushing230of magnetic thyroid cartilage implant200is screwed into anchoring flange240of the magnetic thyroid cartilage implant200to the desired depth, all while being visualized.

At a step518, body220of magnetic thyroid cartilage implant200that holds magnet210is press-fit into slotted end232of translational bushing230of magnetic thyroid cartilage implant200, as shown inFIG.15, and thereby magnetically engage magnetic thyroid cartilage implant200with slotted flange314of magnetized arytenoid locking screw300, as shown inFIG.16. In this step, the use of magnetic force instead of mechanical interaction between this trans-cervical component (i.e., magnetic thyroid cartilage implant200) and magnetized arytenoid locking screw300can reduce or entirely eliminate the possibility of fistula formation or disengagement of magnetized arytenoid locking screw300.

At a step520, the placement of magnetic thyroid cartilage implant200with respect to magnetized arytenoid locking screw300is confirmed visually using, for example, translaryngeal endoscopy and wherein the depth of translational bushing230in anchoring flange240may be adjusted until the appropriate amount of vocal fold lateralization is achieved.

In embodiments directed to medialization, the polarity of the multi-component device (preferably magnet210) can be reversed to push the implanted magnetic device medially and as a result, medialize the vocalis process. The amount of lateralization and/or medialization will be optimized based on a particular subject's need with options to implant magnets of differing strengths and polarity to achieve the desired result.

In summary and referring again toFIG.1throughFIG.16, the presently disclosed magnetic vocal fold manipulator system100and method500can be used to manipulate (lateralization and/or medialization) the vocal cord(s) in those with permanent vocal fold paralysis. Magnetics-based thyroid cartilage implant110and magnetics-based arytenoid cartilage implant120are fully adjustable, allowing the final position of the vocal cord to be modified to maximize the quality of the patient's voice following the procedure. For example, magnetics-based thyroid cartilage implant110is provided that includes a magnet is inserted through the thyroid cartilage and magnetics-based arytenoid cartilage implant120is provided that is magnetically responsive and can reversibly move the vocal process region of the arytenoid cartilage. The interaction of magnetics-based thyroid cartilage implant110and magnetics-based arytenoid cartilage implant120by magnetic force allows for the lateralization of the arytenoid. In the case of medialization, the polarity of the magnet in magnetics-based thyroid cartilage implant110can be reversed in order to push magnetics-based arytenoid cartilage implant120medially and as a result, medialize the vocalis process. The amount of lateralization/medialization can be optimized based on patient need with options to implant magnets of differing strengths and polarity to achieve the desired result. Additionally, the presently disclosed magnetic vocal fold manipulator system100and method500is fully adjustable, fully reversible, and greatly reduces the amount of tissue stress at the cricoarytenoid joint.

In still yet other embodiments, an electromagnetic component can allow the presently disclosed magnetic vocal fold manipulator system100and method500to be used in conjunction with laryngeal pacing technology, thus allowing for dynamic vocal fold motion in those with paralysis even without an intact peripheral neural pathway and/or end muscle atrophy. Currently, laryngeal pacing (see, e.g., U.S. Pat. No. 7,069,082B2, for Pacemaker for Bilateral Vocal Cord Autoparalysis, to Lindenthaler, issued Jun. 27, 2006, which is incorporated herein by reference in its entirety)) only allows for restoration of movement in patients with an intact peripheral neural pathway or via direct muscle stimulus. The addition of this technology as an adjunct to a laryngeal pacer would therefore allow dynamic vocal fold motion in a larger patient population. Moreover, the presently disclosed magnetic vocal fold manipulator system100and method500may prove to be a more clinically effective model than conventional methods. Although the feasibility of these pacing devices has been demonstrated, there has not been significant improvement in patient voice outcomes using their implantation alone.

Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this presently described subject matter belongs.

Following long-standing patent law convention, the terms “a,” “an,” and “the” refer to “one or more” when used in this application, including the claims. Thus, for example, reference to “a subject” includes a plurality of subjects, unless the context clearly is to the contrary (e.g., a plurality of subjects), and so forth.

Throughout this specification and the claims, the terms “comprise,” “comprises,” and “comprising” are used in a non-exclusive sense, except where the context requires otherwise. Likewise, the term “include” and its grammatical variants are intended to be non-limiting, such that recitation of items in a list is not to the exclusion of other like items that can be substituted or added to the listed items.

For the purposes of this specification and appended claims, unless otherwise indicated, all numbers expressing amounts, sizes, dimensions, proportions, shapes, formulations, parameters, percentages, parameters, quantities, characteristics, and other numerical values used in the specification and claims, are to be understood as being modified in all instances by the term “about” even though the term “about” may not expressly appear with the value, amount or range. Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are not and need not be exact, but may be approximate and/or larger or smaller as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art depending on the desired properties sought to be obtained by the presently disclosed subject matter. For example, the term “about,” when referring to a value can be meant to encompass variations of, in some embodiments, ±100% in some embodiments ±50%, in some embodiments ±20%, in some embodiments ±10%, in some embodiments ±5%, in some embodiments ±1%, in some embodiments ±0.5%, and in some embodiments ±0.1% from the specified amount, as such variations are appropriate to perform the disclosed methods or employ the disclosed compositions.

Further, the term “about” when used in connection with one or more numbers or numerical ranges, should be understood to refer to all such numbers, including all numbers in a range and modifies that range by extending the boundaries above and below the numerical values set forth. The recitation of numerical ranges by endpoints includes all numbers, e.g., whole integers, including fractions thereof, subsumed within that range (for example, the recitation of 1 to 5 includes 1, 2, 3, 4, and 5, as well as fractions thereof, e.g., 1.5, 2.25, 3.75, 4.1, and the like) and any range within that range.

REFERENCES

All publications, patent applications, patents, and other references mentioned in the specification are indicative of the level of those skilled in the art to which the presently disclosed subject matter pertains. All publications, patent applications, patents, and other references (e.g., websites, databases, etc.) mentioned in the specification are herein incorporated by reference in their entirety to the same extent as if each individual publication, patent application, patent, and other reference was specifically and individually indicated to be incorporated by reference. It will be understood that, although a number of patent applications, patents, and other references are referred to herein, such reference does not constitute an admission that any of these documents forms part of the common general knowledge in the art. In case of a conflict between the specification and any of the incorporated references, the specification (including any amendments thereof, which may be based on an incorporated reference), shall control. Standard art-accepted meanings of terms are used herein unless indicated otherwise. Standard abbreviations for various terms are used herein.Cummings, C. W., E. E. Redd, W. H. Westra, and P. W. Flint. “Minimally Invasive Device to Effect Vocal Fold Lateralization.” Ann Otol Rhinol Laryngol. 108.9 (1999): 833-36.Cummings, C. W., P. W. Flint, and P. J. Scranton. Vocal Cord Lateralization and Medialization Device and Method. U.S. Pat. No. 5,593,439 A. 14 Jan. 1997.Mueller A H, Hagen R, Foerster G, Grossmann W, Baumbusch K, Pototschnig C. Laryngeal pacing via an implantable stimulator for the rehabilitation of subjects suffering from bilateral vocal fold paralysis: A prospective first-in-human study. Laryngoscope 2016; 126:1810-1816.Li Y, Garrett G, Zealear D. Current Treatment Options for Bilateral Vocal Fold Paralysis: A State-of-the-Art Review. Clin Exp Otorhinolaryngol 2017; 10:203-212.Noriyuki O, Kuratani T, Hagihira S, Kazumi K I, Kaneko M, Mori T. Vocal cord paralysis after aortic arch surgery: Predictors and clinical outcome. Journal of Vascular Surgery. 2006 April; 43 (4): 721-728.Young V, Zullo T, and Rosen C: Analysis of Laryngeal Framework Surgery: 10-Year Follow-up to a National Survey. Laryngoscope, 120:1602-1608, 2010Sulica L, and Blitzer A: Preface in Vocal Fold Paralysis ed Sulica L and Blitzer A Springer New York 2006

Although the foregoing subject matter has been described in some detail by way of illustration and example for purposes of clarity of understanding, it will be understood by those skilled in the art that certain changes and modifications can be practiced within the scope of the appended claims