TWM541287U - An implant system for treating glottic insufficiency - Google Patents

Abstract

An implant system to treat glottic insufficiency is disclosed. The implant system includes an implant with a medialization block, a band, and a fixation frame. The band has a proximate end attached to a portion of the medialization block. Position of the medialization block is adjustable. A tension of the band is adjusted in response to the adjusted position of the medialization block, which in turn rotate an arytenoid cartilage to medialize and tighten a vocal cord.

Description

Implant system for the treatment of glottic insufficiency

Dysphagia associated with aspiration pneumonia often occurs in patients with neurological disorders. Nervous system diseases can be caused by stroke, brain surgery, head and/or spinal cord injury, oropharyngeal disease, radiation therapy, heart/thoracic surgery, autoimmune or other degenerative neurological diseases. Aspiration pneumonia can be mainly caused by glottic insufficiency, which is due to vocal cord paralysis with or without swallowing dysfunction. Patients with stroke with inhalation may have a seven-fold higher risk of aspiration pneumonia than other types of patients. For these stroke patients, there is a relatively high incidence of dysphagia associated with aspiration pneumonia even after rehabilitation.

Conventional surgical techniques for treating dysphagia and glottic insufficiency may include a first type of Medialization Thyroplasty (MT) surgical procedure and an Arytenoid Adduction (AA) procedure. The first type of MT procedure is the primary vocal procedure for patients with glottic insufficiency. The main limitations of the first type of MT procedure include the inability to close the wide posterior glottal suture and restore physiological swallowing steps such as laryngeal lift and vocal cord movement. For patients with vocal cord paralysis and a significant posterior glottic space after the first type of MT procedure, an AA procedure can be performed to close the glottis after incomplete closure. Nonetheless, one limitation of the AA procedure associated with posterior airway closure is the increased frequency of postoperative airway complaints following the AA procedure, due to postoperative tissue edema in the glottic region. In addition, Type 1 MT and AA surgical procedures may not be suitable for patients who have difficulty with prolonged supine position or who are unable to tolerate long-term, long-term surgical procedures.

Because of the use of implant or suture fixation techniques in both surgical procedures, complaints common to such procedures are that the implant or suture cannot be adjusted during surgery. Cutting the implant during surgery can result in prolonged surgical time and poor implant formation.

Several studies have shown that first-type MT combined with AA results in improved sound quality and reduces the incidence of aspiration pneumonia. However, the main drawbacks are long operative time and possible complications. In addition, the degree of vocal cord internal migration and/or sacral cartilage inversion may not be adjusted during surgery. Providing an adjustable implant for the surgical procedure will shorten the surgical operation time and reduce the risk of airway damage after surgery. The adjustable implant will be tailored to individual individual needs, thereby greatly benefiting the patient.

In an example of the present disclosure, an implant system for treating a glottic insufficiency includes an implant having a glottal internal transfer block, a band, and a fixed frame. The strap has a proximal end attached to a portion of the vocal cord inner shifting block. The position of the vocal cord internal shifting block is adjustable, which in turn adjusts the tension of the belt, which in turn rotates the sacral cartilage to move and tighten the vocal cords.

110‧‧‧ Figure

111‧‧‧ outside the thyroid cartilage

112‧‧‧Rigid ligament

113‧‧‧ upper corner of thyroid cartilage

114‧‧‧ thyroid periosteum

115‧‧ ‧ tongue

116‧‧‧ epignea cartilage

117‧‧‧ below the thyroid cartilage

118‧‧‧Circular cartilage

119‧‧‧ thyroid notch

11A‧‧‧ trachea

121‧‧‧The inside of thyroid cartilage

120‧‧‧ Figure

122‧‧‧vocal ligament

123‧‧‧Top angle of thyroid cartilage

124‧‧‧ thyroid periosteum

125‧‧ ‧ tongue

126‧‧‧ epignea cartilage

127‧‧‧ below the thyroid cartilage

128‧‧‧Circular cartilage

129‧‧‧ Small horny cartilage

12A‧‧‧ trachea

12B‧‧‧Sacral cartilage

130‧‧‧ Figure

131‧‧‧ sectional view of thyroid cartilage

132‧‧‧杓 会

133‧‧ ‧ tongue

134‧‧‧ epignea cartilage

135‧‧‧post cartilage

136‧‧‧ vocal cord

137‧‧‧ 杓 软骨 软骨 软骨 软骨

138‧‧‧Carbon cartilage

139‧‧‧ tracheal ring

13A‧‧‧ throat entrance

140‧‧‧ Figure

141‧‧‧ vocal cords

142‧‧‧ vocal cords

150‧‧‧ Figure

151‧‧‧ vocal cords

160‧‧‧ Figure

161‧‧‧ vocal cord closure

162‧‧  laryngeal elevation

170‧‧‧ Figure

171‧‧‧ thyroid cartilage

172‧‧‧Cartilage opening

200‧‧‧ implant system

201‧‧‧Fixed frame

202‧‧‧Intra-belt shifting block

203‧‧‧带/条

204‧‧‧ thyroid cartilage

205‧‧‧ vocal cords

206‧‧‧ Hyperthyroid muscle complex

207‧‧‧Sacral cartilage

214‧‧‧ proximal end

215‧‧‧ distal

301‧‧‧Circular cartilage

401‧‧‧ stitching

501‧‧‧Mechanism of protruding buckles and holes

502‧‧‧ trench

601‧‧‧Cartilage opening

Figure 1A illustrates various diagrams of the anatomy of the larynx.

Figure 1B illustrates various symptoms of glottic insufficiency.

2A and 3A illustrate top and side views of an implant system in an example of the present disclosure having an implant and a device for treating glottic insufficiency in the paraglottic space The implant is attached to one of the stents on the thyroid cartilage.

The second B and third B diagrams illustrate the mechanisms of the implants of the second and third panels in the examples of the present disclosure.

4A and 4B illustrate a method of joining the implant of the second figure and the nail muscle in the example of the present disclosure.

5A and 5B illustrate a method of attaching a vocal cord internal transfer block to a fixed plate in the example of the present disclosure.

The sixth figure illustrates the stent of the implant system of Figure 2 in the example of the present disclosure having an external clamp that conforms to the cartilage opening.

In the following embodiments, reference is made to the accompanying drawings, which form a part of the present invention. In the drawings, like symbols generally indicate similar components, unless otherwise indicated herein. The illustrative embodiments described in the embodiments, drawings, and claims are not intended to be limiting. can Other embodiments may be made and other changes may be made without departing from the spirit or scope of the subject matter presented herein. It will be immediately apparent to those skilled in the art that the present disclosure (as generally described herein and illustrated in the drawings) can be configured, substituted, combined, and designed in various configurations, all of which are expressly contemplated herein.

The present disclosure describes treatment of dysphagia, glottic insufficiency (due to neuromuscular incoordination or interaction between disorders within the larynx muscle (cooperative)), and poor closure of the larynx (opening) (due to uncoordinated bending and laryngeal epiglottis) Apparatus and method for delay or lack of elevation. The disclosed treatments improve glottic closure, reduce the incidence of inhalation, and thus avoid inhalation sequelae, such as aspiration pneumonia. In addition, the disclosed treatment is capable of achieving an intraoperative adjustment of the glottic closure. As a result, the disclosed treatments can shorten the surgical operation time during the surgical procedure and effectively reduce/avoid aspiration pneumonia after the surgical procedure.

In the example of the present disclosure, an implant system simulates contraction of the nail muscle by rotating the sacral cartilage to close the glottis. The present disclosure can replace both the first type of thyroid cartilage and the AA surgical technique because it provides intraoperative adjustments that shorten the time of surgery and glottic closure.

Figure 1A illustrates various diagrams of the anatomy of the larynx.

Figure 110 is a front view showing the patient's laryngeal anatomy, including a thyroid cartilage outer side 111, a toroidal ligament 112, a thyroid cartilage upper corner 113, a thyroid tongue periosteum 114, a hyoid bone 115, a epiglottic cartilage 116, a hypothyroid angle 117, a ring cartilage 118, a thyroid notch 119 and a trachea 11A. Wherein the 111 side of the thyroid cartilage is exposed. Figure 120 is a rear view showing the throat of the same patient, including the inner side 121 of a thyroid cartilage, a vocal cord ligament 122, a thyroid cartilage upper corner 123, a thyroid tongue periosteum 124, a hyoid bone 125, an epiglottic cartilage 126 , a lower thyroid cartilage angle 127, a ring cartilage 128, a small horn cartilage 129, a tracheal 12A and a sacral cartilage 12B. The inner 121 of the thyroid cartilage is exposed. Figure 120 further shows the vocal cord ligament 122 of the patient enclosed within the vocal cords of the patient (not shown in Figure 120). Figure 130 shows the laryngeal cartilage of the same patient (including the cross-sectional view 131 of the thyroid cartilage) in an oblique side view, including a cross-sectional view 131 of a thyroid cartilage, a crested epiglottis 132, a tongue 133, a epiglottis Cartilage 134, a posterior cartilage 135, a vocal cord 136, a sacral cartilage trace 137, a ring cartilage 138, a tracheal ring 139, and a throat inlet 13A. In the examples of the present disclosure, the space surrounded by the laryngeal cartilage, and the tissues and organs attached to the cartilage, may be considered "Speaking room next to the glottis." In other words, the paraglottic space can be defined by the thyroid cartilage and various surrounding membranes.

Figure 1B illustrates various symptoms of glottic insufficiency.

Figure 140 illustrates an exemplary sound vocal cord having two side vocal cords 141 and 142. The two vocal cords 141 and 142 are cooperatively opened and closed during normal breathing, swallowing or speaking. Before the individual swallows the food, the food or drink is first crushed and/or mixed into a paste-like mass known as a bolus. During swallowing, the individual's extralaryngeal muscle cooperates with the larynx muscle to prevent food or drink from entering the glottis. For example, an individual's extralaryngeal muscle raises the throat and bends the epiglottic cartilage above the glottic entrance so that the bolus can slide over the epiglottic cartilage rather than falling into the throat. At the same time as this action is performed, the individual's intralaryngeal muscle closes the glottis. In the event that any food particles or liquid touches the surface of the vestibule or vocal cords 141 and 142, a cough reflex can be triggered to prevent the substance from entering the glottis.

Figure 150 illustrates an exemplary unsound vocal cord having a vocal cord 151 that cannot be moved to a fully lateralized/inwardly displaced position. In other words, the vocal cord 151 cannot be opened and closed in conjunction with other vocal cords, leaving an opening or gap in the glottis. Thus, during swallowing, the bolus can inadvertently slide into the throat and then slide into the airway, bronchi, and lungs, which can cause infection and pneumonia. In addition, as shown in FIG. 160, for some stroke patients, due to impaired nerve stimulation, the triggering of the epiglottic cartilage, vocal cord closure 161, and/or laryngeal elevation 162 is delayed or absent, resulting in extralaryngeal muscle and larynx. Internal muscle movement is not coordinated. As a result, the patient may have difficulty swallowing and congestion.

To treat a patient's glottic insufficiency and/or difficulty swallowing, FIG. 170 shows that a surgeon or medical machine utilizes a surgical device to create a cartilage opening 172 in a patient's thyroid cartilage 171. The surgical device can perform certain functions such as drilling, shaping, spatial expansion (eg, "peeling"), and instrument/implant delivery. Thereafter, the surgeon or medical machine places the implant system through the cartilage opening 172 into the parasitic space behind the patient's thyroid cartilage 171. The implant system is configured to facilitate flexion of the epiglottic cartilage or to perform a laryngeal elevation such that the paralyzed throat is preferably closed during swallowing of the bolus.

The second A diagram illustrates a top view of one of the implant systems 200 in the example of the present disclosure positioned in the paraglottic space for the treatment of glottal insufficiency. The top of the figure is the front side of the throat and the lower part of the figure is the back side of the throat. The implant system 200 includes at least one fixed frame 201, at least one vocal cord internal transfer block 202, and at least one strip or strip 203. Via thyroid cartilage 204 The opening or window inserts the fixed frame 201 into the parasitic space. The opening or window will be described in the sixth figure and will be described in detail below. The vocal cord internal transfer block 202 has a shape conforming to the glottic space between the thyroid cartilage 204, the adipose tissue, and the nailfold muscle complex 206. The insertion of the glottic internal transfer block 202 can push the nail muscle complex 206 and the vocal cords 205 inwardly. Movement of the intraglottic mass in the forward and/or inward direction can cause the cartilage 207 to rotate, which can contribute to the glottis closure.

The implant system 200 includes a fixation frame 201 that is secured to an opening in the thyroid cartilage 204. The fixed frame 201 secures the vocal cord internal transfer block 202 to the thyroid cartilage 204.

The vocal cord internal transfer block 202 and the strap 203 are made of a biocompatible material such as a sputum or biodegradable material. The vocal cord internal transfer block 202 can be constructed of various rigidities.

The strap 203 can be rigid, semi-rigid, or soft. It can be made by integrating a mesh textile into a biocompatible material. The rigidity of this layer can be varied by the mesh density of the integrated textile. The band 203 has a proximal end attached to one of the portions of the vocal cord internal transfer block 202. The portion may be part of the upper surface, the lower surface, the side surface, or the inner surface of the vocal cord inner block 202.

The second B diagram shows the therapeutic effect of the implant system 200 after implantation in the paraglottic space. The position of the vocal cord internal transfer block 202 can be adjusted during the surgical procedure (in operation), which in turn adjusts the tension of the band 203, which in turn adjusts the rotation of the sacral cartilage. Thus, the implant system 200 can effectively move and tighten the paralyzed vocal cords 205. As a result, the risk of aspiration pneumonia can be significantly reduced. The implant system 200 can likewise be adjusted and readjusted during surgery. Thus, the implant system 200 can allow for faster surgical operation time, which in turn increases the patient's acceptance of the surgical procedure.

Figure 3A illustrates a side view of the implant system 200 in the example of the present disclosure positioned in the paraphaltric space for the treatment of glottal insufficiency. The right side of the figure is the front side of the throat and the left side of the figure is the back side of the throat. The vocal cord internal transfer block 202 is placed in a space between the thyroid cartilage 204, the adipose tissue, and the nail muscle complex 206. The portion of the glottic internal transfer block 202 indirectly contacts the sacral cartilage 207 via the muscle and connective tissue therebetween. The proximal end of the strap 203 can be integrated into or attached to the side surface, the upper surface, and/or the lower surface of the vocal cord inner block 202, and the distal end of the strap 203 is by, for example, a suture , clips, or hooks are attached to or attached to the posterior portion of the nail complex 206.

The movement of the vocal cord internal transfer block 202 can facilitate the inward movement of the vocal cord 205 (Fig. 2A) and both rotations of the sacral cartilage 207. The vocal cord internal transfer block 202 can also be positioned vertically, thereby reaching the supraglottic space, causing laryngeal elevation during swallowing and accelerating the epiglottic cartilage closure. The glottal internal transfer block 202 can be moved into the parasitic space to enhance the closure of the paralyzed vocal cord 205 to a nearly complete or fully inwardly displaced position.

The second and third B diagrams illustrate the mechanism of the implant system 200 in the example of the present disclosure for bringing the paralyzed vocal cords 205 illustrated in the second panel A to a position that is nearly completely or completely displaced. The second A and third A diagrams illustrate the implant system 200 prior to the movement of the vocal cord internal transfer block 202, and the second B and third B diagrams illustrate the implant system 200 after the vocal cord internal transfer block 202 has been moved. Movement of the vocal cord internal transfer block 202 causes the belt 203 to move in the designed direction. The movement of the band 203 causes a pulling force on the nail complex 206. The pulling of the nailfold muscle complex 206 causes the cartilage 207 to rotate. Rotation of the sacral cartilage 207 positions the paralyzed vocal cord 205 illustrated in Figure 2A in a position that is nearly completely or completely displaced.

4A and 4B illustrate a method of connecting the vocal cord internal transfer block 202 and the nail muscle complex 206 in the example of the present disclosure. One or more straps 203 are attached to the vocal cord internal transfer block 202. In the fourth A diagram, the band 203 is wrapped around the nail muscle complex 206 with the proximal end 214 of the band 203 attached to the vocal cord internal transfer block 202. For example, the proximal end 214 of the band 203 is attached to the upper surface of the vocal cord internal transfer block 202 while the distal end 215 of the band 203 is attached to the lower surface of the vocal cord internal transfer block 202. In the fourth B diagram, the band 203 is attached to the nail muscle complex 206 by sutures, clips, or hooks. For example, the proximal end 214 of the strap 203 is attached to the upper surface, the lower surface, the side surface, or the inner surface of the vocal cord internal transfer block 202, while the distal end 215 of the strap 203 is attached to the nailfold muscle with the suture 401. Complex 206.

The movement of the band 203 (after interconnection with the nail complex 206) causes a pulling force on the nail complex 206 which causes the cartilage 207 (second A and second B) Rotate. This connection may also provide fixation of the implant to prevent any relative movement in the space adjacent the glottis.

The fifth figure illustrates a method of attaching the vocal cord internal transfer block 202 to the fixed frame 201 in the example of the present disclosure. The vocal cord internal transfer block 202 can be attached to the fixed frame 201 having a mechanism 501 for protruding buckles and holes (Fig. AA). The vocal cord internal transfer block 202 can also be attached to the fixed frame 201 having the grooves 502. The vocal cord internal transfer block 202 can be moved and implanted at different locations in the parasal space.

The sixth figure illustrates a fixation frame 201 that fits the cartilage opening 601 in the example of the present disclosure. A surgeon or medical machine utilizes a surgical device to create a cartilage opening 601 on the thyroid cartilage 204 of the patient. The cartilage opening 601 can have a circular or rectangular shape. The surgical device (without limitation) can be a shear, drill, saw, or drill (eg, a Kerrison drill). The surgical tool can be operated manually, electrically, mechanically, or magnetically.

After the surgeon or medical machine delivers the implant into the paraglottic space of the patient, the fixation frame 201 is placed into the cartilage opening 601. The fixing frame 201 can be manufactured by using materials such as titanium, polyetheretherketone, elastomer, polyfluorene oxide, polymer, synthetic material, ENT synthetic material, porous polyethylene, ENT synthesis. Materials - PIFE, 矽 elastomer, polyethylene, and polyurethane. The fixation frame 201 can be flexible such that it can be squeezed into the cartilage opening 601. The fixation frame 201 can have a flange that covers the cartilage opening 601. The flanges prevent crack enlargement or increase or damage at the edges of the cartilage opening 601 during surgery. The fixing frame 201 may have a rough outer side surface. As a result, when the fixation frame 201 is placed into the cartilage opening 601, the rough outer surface can generate sufficient friction to stabilize the fixation frame 201 without sliding or rolling in the cartilage opening 601. The fixation frame 201 can be further fixed to the thyroid cartilage 204 by nails or screws. In addition, the fixation frame 201 can also function as an insertion plate, thereby preventing the vocal cord internal transfer block 202 from being damaged by the rough surface of the cartilage window during implantation.

Referring back to Figures 2A and 2B, in some examples of the disclosure, the implant system 200 has mechanical, electrical, magnetic, or piezoelectric actuators. The actuator is elongatable to pull the band 203, which in turn pulls the nail muscle complex 206, which in turn rotates the cartilage 207 to move and tighten the vocal cord 205.

In other examples of the present disclosure, the implant system 200 has a vocal cord internal transfer block 202 that is a fixed size. The implant system 200 is selected from implants having bodies of different sizes to match the paraglottic space of a patient. Alternatively, material is removed from the vocal cord internal transfer block 202 to match the parasitic space of the patient. The length between the attachment points of the band 203 determines the tension on the nail muscle complex 206, which in turn determines the rotation of the cartilage 207.

Accordingly, devices and methods for treating glottic insufficiency have been disclosed. Various embodiments described herein may employ devices or devices for performing such methods. The device can be specially manufactured for specific needs, or it can be selected by a computer program stored in a computer. A universal computer that is activated or set up selectively. In particular, various general purpose machines may be used with computer programs written in accordance with the teachings herein, or it may be more convenient to construct a more specialized apparatus to perform the desired operations. The various embodiments described herein can be implemented in other computer system settings, including: hand-held devices, microprocessor systems, microprocessor-based or programmable consumer electronics, mini-computers, large computers, and the like.

For the sake of clarity, one or more specific embodiments of the present disclosure have been described in terms of certain details, and certain changes and modifications may be made within the scope of the appended claims. The present invention is to be considered as illustrative and not restrictive, and the scope of the claims In the context of the patent application, the elements and/or steps do not imply any specific order of operation unless explicitly stated in the scope of the claims.

For the components, operations, or structures described herein, the plural cases may be provided as a singular case. Finally, the boundaries, operations, and data storage between the various components are somewhat arbitrary, and the particular operational description is in the context of a particular illustrative configuration. The assignment of other functions is contemplated and may be within the scope of the present disclosure. In general, the structures or components that can be combined in the structure and function of the various components are shown in the exemplary configuration. Similarly, the structures and functions presented as a single component can be implemented in various components. These and other variations, modifications, additions, and improvements will fall within the scope of the accompanying claims.

200‧‧‧ implant system

201‧‧‧Fixed frame

202‧‧‧Intra-belt shifting block

203‧‧‧带/条

204‧‧‧ thyroid cartilage

205‧‧‧ vocal cords

206‧‧‧ Hyperthyroid muscle complex

207‧‧‧Sacral cartilage

Claims (11)

An implant system for treating a glottic insufficiency, comprising: an implant comprising: a vocal cord internal transfer block; and a band comprising a proximal end attached to one of a portion of the vocal cord internal transfer block , wherein the tension of the belt is adjusted to rotate the sickle cartilage in response to a change in the position of the shifting block within the vocal cord. The implant system of claim 1, wherein the vocal cord internal transfer block is substantially triangular. The implant system of claim 1, wherein the strip comprises a mesh textile integrated into a biocompatible material. The implant system of claim 1, wherein the proximal end of the strap is attached to an upper surface, a side surface, a lower surface, or an inner side surface of the inner belt of the vocal cord. The implant system of claim 1, wherein the vocal cord internal transfer block is structurally designed to be placed in the paraglottic space between the thyroid cartilage, the adipose tissue, and the nailfold muscle complex. The implant system of claim 5, wherein the strip comprises a distal end attached to one of the nail complexes. The implant system of claim 5, further comprising a fixed frame that matches a window that is open in the thyroid cartilage and attached to one of the vocal cord internal transfer blocks. The implant system of claim 7, wherein the change in the position of the inner band of the vocal cord is in response to movement of the inner block of the vocal cord relative to the fixed frame. The implant system of claim 8 wherein the fixed frame defines a plurality of apertures that are complementary to a set of raised buckles on the inner belt of the vocal cord. The implant system of claim 8, wherein the fixation frame defines a first set of grooves that are complementary to a second set of grooves defined on the transfer block within the vocal cord. The implant system of claim 8, wherein the fixation frame comprises a flange, a rough surface, or is attached to the thyroid cartilage.