TW201609066A - Implant used for building tunnel under dorsal lingual mucosa - Google Patents

Abstract

Disclosed is an implant used for building a tunnel under dorsal lingual mucosa, including an implant capable of being implanted on the dorsum of tongue and at least one fixed belt. Once the implant is implanted into the dorsum of tongue, the fixed belt is able to circle the tongue tissue above the implant so as to connect and fix onto the implant, which forms an enclosed connection between the implant and the fixed belt. The enclosed connection structure between the implant and the fixed belt enables medical materials with extreme softness to be adopted and manufactured as an implant or a fixed belt, which prevents the implant from shifting or falling off when the tongue is doing speaking, chewing or swallowing movement; hence, the disclosed implant reduces a feeling of foreign body and increases the degree of comfort.

Description

Implant for establishing submucosal tunnel of the tongue

The present invention relates to a surgical implant implanted on the tongue, in particular a tongue-back elastic traction device for treating snoring and obstructive sleep apnea hypopnea syndrome (Obstructive Sleep Apnea/Hypopnea Syndrome, hereinafter referred to as OSAHS). An implant used to establish a submucosal tunnel of the tongue.

Obstructive sleep apnea hypopnea syndrome (OSAHS) is a sleep-disordered breathing disorder characterized by snoring, apnea, and hypopnea caused by collapse and occlusion of the soft tissue of the upper airway during sleep.

For the pathogenesis of OSAHS, it is generally believed that many factors work together. In addition to the narrow anatomy of the upper airway, the main reason is the relaxation of the pharyngeal muscle that maintains the upper airway during sleep, and the collapse of the soft tissue. The obstruction site is mostly located in the pharyngeal plane or the pharyngeal plane.

Studies have shown that 20%-25% of patients with OSAHS are caused by soft tissue collapse in the simple pharyngeal plane. 15%-20% of OSAHS patients are caused by soft tissue collapse in the simple pharyngeal plane, and 50%-70% of OSAHS patients At the same time, there is a soft tissue collapse of the pharyngeal plane and the pharyngeal plane, that is, mixed OSAHS patients.

In order to treat the OSAHS formed by the collapse of the soft tissue of the lingual pharynx caused by the fall of the tongue, the present inventors have disclosed an implantable tongue-root traction device in the Chinese patent application CN102198010 A, which has obtained a good clinical effect. It is especially suitable for the surgical treatment of patients with moderate or severe OSAHS due to collapse of the tongue.

Further, the inventor of the present invention is in Chinese patent application 201310043949.5 The present invention discloses a tongue-back elastic traction device and an implantation method, and provides a tongue-back elastic traction device for treating patients with mild or moderate OSAHS caused by collapsing of the tongue, which has less trauma, more comfort, and more use. Convenient advantages. This patent application provides an implant for use in establishing a sublingual submucosal tunnel in conjunction with such a tongue-back elastic traction device.

Referring to the drawings of the present invention, an implant for establishing a sublingual submucosal tunnel, the implant comprising an implant 1 implantable on the back of the tongue, and at least one fixation strip 2; The body 1 is implanted behind the tongue, and the fixing strip 2 can be attached to the implant 1 by means of a tongue tissue 3 above the implant 1 to form a closure between the implant 1 and the strap 2 connection.

The implant 1 is a thin-walled tubular structure or rod-like structure having an arc that is adapted to the submucosal tunnel of the tongue to be established. The thin-walled tubular structure or the rod-shaped implant 1 has a curvature corresponding to the curvature of the submucosal tunnel to be established, which can be customized according to the shape of the tongue of a specific patient, or can be manufactured into several commonly used Specifications are available to clinicians. The thin-walled tubular structure or the rod-shaped implant 1 has an arc corresponding to the sublingual submucosal tunnel to be established, so that the implant 1 can be left on the back of the tongue after being removed and taken out. The submucosal tunnel that needs to be established has a set curvature.

The left end 11 of the implant 1 is provided with a left positioning convex step 11-1; the right end 12 of the implant 1 is provided with a right positioning convex step 12-1. On the one hand, the left positioning projection 11-1 and the right positioning projection 12-1 can prevent the implant 1 from slipping off to some extent, and on the other hand can connect or fix the fastening strap 2.

Further, when the implant 1 adopts a thin-walled tubular structure, the thin-walled tubular structure of the implant 1 includes a through hole 10.

The through hole 10 can pass through a thread such as a surgical line, and can be pulled to see if there is pain, thereby judging whether the submucosal tunnel is completely epithelial. Whether the wound is completely healed; at the same time, the fixing tape 2 can also be passed through the through hole 10 for fixing the fixing tape 2.

The strap 2 includes a strap 20 that is in contact with the mucosal surface of the tongue, which strap 20 is a smooth ribbon-like structure.

The strap 20 is smooth, soft and elastic, and fits tightly against the surface mucosa of the tongue in contact with it to improve comfort.

The fixing strap 2 includes a guiding head 21 and at least one positioning block 22, and the guiding head 21 is disposed at a front end of the positioning block 22. This fixing belt 2 including the guide head 21 can be easily operated. When the fixing strap 2 includes a plurality of the positioning blocks 22, by selecting different positioning blocks 22, the degree of tension of the strapping tape 20 to the tongue mucosa can be conveniently adjusted.

The positioning block 22 of the fixing strap 2 has an outer diameter matching the inner diameter of the through hole 10 of the implant 1, and the positioning block 22 can be embedded in the through hole 10 of the implant 1 to form Fixed connection. When the positioning block 22 on the fixing belt 2 is embedded in the through hole 10 of the implant 1, the protrusion which is in contact with the oral mucosa is reduced, and the use is more comfortable.

Further, the positioning block 22 is provided with a positioning convex step 22-1, and the positioning convex step 22-1 is stuck at the end of the implant body 1. Increasing the positioning projection 22-1 prevents the positioning block 22 of the fixing strap 2 from slipping out of the through hole 10 of the implant 1.

The fixing strap 2 includes a positioning hole 23 . According to a specific design, the positioning hole 23 can be sleeved at the end of the implant 1 to form a fixed connection; or the positioning block 22 on the fixing strap 2 can be formed with a concave-convex card.

The positioning hole 23 can be sleeved at the end of the implant 1 to form a closed fixed connection. When the rigidity of the implant 1 is relatively good, if the implant 1 is made of titanium alloy, or made of medical plastic, or a solid glue stick, the positioning hole 23 on the fixing strip 2 can be directly A sleeve is placed on both ends of the implant 1 to form a fixed connection.

One end of the fixing strap 2 is connected to one end of the implant 1; the implant 1 is implanted behind the tongue, and the other end of the fixing strap 2 bypasses the tongue tissue 3 above the implant 1 The positioning hole 23 on the fixing strap 2 is sleeved at the other end of the implant body 1 to form a closed fixed connection.

One end of the fixing strap 2 is connected to one end of the implant 1; the implant 1 is implanted behind the tongue, and the other end of the fixing strap 2 bypasses the tongue tissue 3 above the implant 1 The positioning hole 23 provided on the other end of the implant 1 forms a closed fixed connection.

One end of the fixing strap 2 is connected to one end of the implant 1; the implant 1 is implanted behind the tongue, and the other end of the fixing strap 2 bypasses the tongue tissue 3 above the implant 1 The inlaid in the through hole 10 of the implant 1 forms a closed fixed connection.

The implant 1 is made of a medical material, and the fixing strip 2 is made of a medically flexible material.

Further, the implant 1 and the fixing strap 2 are integrally manufactured by using a medical flexible material selected from the group consisting of medical silicone, medical polyurethane, medical rubber, medical latex, and medical polyethylene. .

The implant for establishing a sublingual submucosal tunnel of the present invention comprises an implant 1 implantable on the back of the tongue and at least one fixation strip 2; the implant 1 is implanted behind the tongue, said The fastening strip 2 can be attached to the implant 1 by means of a tongue tissue 3 over the implant 1 , forming a closed connection between the implant 1 and the fastening strip 2 . The closed connection structure between the implant 1 and the fixing strap 2 makes it possible to manufacture the implant 1 and the fixing strap 2 with a very soft medical material, in order to prevent the tongue from being in different movements such as pronunciation, chewing, swallowing and the like. Displacement and shedding occur, which reduces the sense of foreign body and improves comfort.

1‧‧‧ implant

10‧‧‧through hole

11‧‧‧ Left end of the implant

11-1‧‧‧ Positioning step

12‧‧‧ right end of the implant

12-1‧‧‧ Positioning step

2‧‧‧Fixed tape

20‧‧‧ straps

21‧‧‧Director

22‧‧‧ Positioning block

22-1‧‧‧ Positioning step

23‧‧‧Positioning holes

3‧‧ ‧ tongue tissue

Figure 1 is a fragmented type of the invention for establishing a submucosal tunnel of the tongue Schematic diagram of the structure when the material is not assembled.

Fig. 1-1 is a schematic view showing the structure of the disassembled type of the implant for constructing the submucosal tunnel of the tongue.

Figure 1-2 is a cross-sectional view taken on line 1-1.

Figure 1-3 is a diagram of the structure and working principle.

Fig. 2 is a schematic view showing the structure of the hole-connected type of the implant for establishing a sublingual submucosal tunnel of the present invention.

Fig. 2-1 is a schematic view showing the structure of the hole-connecting type of the implant for constructing the submucosal tunnel of the tongue.

Figure 2-1 is a cross-sectional view taken on line 2-1.

Figure 2-3 is a diagram of the structure and working principle.

Fig. 3 is a schematic view showing the structure of the bead-type implant of the present invention for establishing a submucosal tunnel of the tongue.

Figure 3-1 is a cross-sectional view of Figure 3.

Fig. 3-2 is a schematic view showing the structure of the bead-type assembly of the present invention for establishing a submucosal tunnel of the tongue.

Figure 3-3 is a diagram of the structure and working principle.

Figure 3-4 is a diagram showing the structure and working principle of the removal of the excess guide head and positioning block in Figure 3-2.

Figure 3-5 is a diagram of the structure and working principle.

Fig. 4 is a schematic view showing the structure of the implant of the present invention for establishing a submucosal tunnel of the tongue.

Fig. 4-1 is a cross-sectional view of Fig. 4.

Figure 4-2 is a mosaic type of the present invention for establishing a submucosal tunnel of the tongue. Schematic diagram of the assembly of the implant.

Figure 4-3 is a diagram of the structure and working principle.

Figure 4-4 shows the structure and working principle of Figure 4-2 after cutting off the excess guide head.

Figure 4-5 is a diagram of the structure and working principle.

Embodiment 1: Split type The implant of the present invention for establishing a submucosal tunnel of the tongue

Referring to FIG. 1 to FIG. 1-3, in the embodiment, the implant 1 is made of medical pure titanium or medical plastic, and the fixing tape 2 is made of medical silicone.

The implant 1 is a smooth curved rod-like structure, and the left side positioning convex step 11-1 and the right side positioning convex step 12-1 are respectively disposed at two ends of the implant body 1.

The strap 2 includes a strap 20 that is in contact with the mucosal surface of the tongue, which strap 20 is a smooth, flat strip-like structure. The strap 20 is smooth, soft and elastic, and fits tightly against the surface mucosa of the tongue in contact with it to improve comfort. Further, a positioning hole 23 is provided at each of both ends of the fixing belt 2. The positioning holes 23 at both ends of the fixing belt 2 can be respectively sleeved on the left positioning convex step 11-1 of the left end 11 of the implant 1 and the right positioning convex step 12-1 of the right end 12. The implant 1 is implanted behind the tongue, and the fixing strap 2 can be attached to the left side of the implant 1 by positioning the tongue tissue 3 above the implant 1 and positioning the convex step 11-1 and the right end 12 On the right side of the positioning step 12-1, a closed connection is formed between the implant 1 and the fixing strip 2, with reference to Figures 1-3.

After the submucosal tunnel is completely epithelialized, the fixation strip 2 is cut with a surgical scissors, and the implant 1 is removed from the tongue, that is, a submucosal tunnel is established on the tongue. This submucosal tunnel can be fitted with a tongue-back elastic traction device to treat snoring or OSAHS.

Since the implant 1 forms a closed connection with the fixation strip 2, the tongue tissue 3 is wrapped therein, so that the implant 1 is avoided regardless of the different movements of the tongue during pronunciation, chewing, swallowing, and the like. Displacement and falling off.

Embodiment 2: Hole-connecting type The implant for constructing a sublingual submucosal tunnel of the present invention

Referring to FIGS. 2 to 2-3, in the present embodiment, the implant 1 and the fixing strap 2 are integrally manufactured using medical silicone.

The implant body 1 is a smooth thin-walled tubular structure, and the left side positioning convex step 11-1 is disposed at the two ends of the implant body 1 respectively. The strap 2 includes a strap 20 that is in contact with the mucosal surface of the tongue, which strap 20 is a smooth, flat strip-like structure. One end of the fixing strap 2 is connected to the right end 12 of the implant body 1, and the other end of the fixing strap 2 is provided with a positioning hole 23, refer to FIG.

The implant 1 is implanted behind the tongue, the fixing strap 2 can bypass the tongue tissue 3 above the implant 1 , and the positioning hole 23 of the fixing strap 2 is placed on the left end of the implant 1 On the positioning convex step 11-1 of 11, a closed connection is formed between the implant 1 and the fixed tape 2, with reference to Figures 2-1 to 2-3.

The through hole 10 of the implant 1 allows a thread such as a surgical line to pass through, and is subjected to trial pulling to see if there is pain, thereby judging whether the submucosal tunnel is completely epithelialized and whether the wound is completely healed. After the submucosal tunnel is completely epithelialized, the fixing strap 2 is removed from the positioning convex step 11-1 of the left end 11 of the implant 1 and the implant 1 is taken out, that is, the tongue is established. Submucosal tunnel of the tongue. This submucosal tunnel can be fitted with a tongue-back elastic traction device for the treatment of snoring or OSAHS.

Since the implant 1 forms a closed connection with the fixation strip 2, the tongue tissue 3 is wrapped therein, so that the implant 1 is avoided regardless of the different movements of the tongue during pronunciation, chewing, swallowing, and the like. Displacement and falling off.

Example 3: Beaded type The implant of the present invention for establishing a submucosal tunnel of the tongue

Referring to Figures 3 to 3-5, in the present embodiment, the implant 1 and the fixing strap 2 are integrally fabricated using medical silicone.

The implant 1 is a smooth thin-walled tubular structure, and a left side positioning step 11-1 and a right side positioning step 12-1 are respectively disposed at two ends of the implant 1. The strap 2 comprises a strap 20 that is in contact with the mucosal surface of the tongue, the strap 20 being a smooth, flexible strip-like structure. There are two fixing straps 2, wherein the proximal end of the left fixing strap 2 is connected with the left end 11 of the implant body 1, and the distal end is provided with a guiding head 21, and the guiding head 21 and the strapping strap 20 are provided. A plurality of positioning blocks 22 are disposed between the proximal end of the right side fixing band 2 and the right end 12 of the implant body 1, and the distal end is provided with a positioning hole 23; refer to FIG. 3 and FIG. 3-1.

The implant 1 is implanted behind the tongue, the left fixing strap 2 bypasses the tongue tissue 3 above the implant 1 , and the guiding head 21 and the positioning block 22 on the left fixing strap are sequentially fixed from the right side. The positioning hole 23 on the distal end of the strap 2 passes through, and the left fixing strap 2 is tightened, so that the strap 20 is in close contact with the surface mucosa of the tongue, and a closed connection is formed between the implant 1 and the fixing strap 2, Figures 3-2 and 3-3.

Surgical shearing of the guide head 21 and the excess positioning block 22 completes the fixation of the implant of the present invention on the tongue, with reference to Figures 3-4 and 3-5. In the implant of the present invention, the tension of the adhesive tape of the fixing tape 2 against the surface of the tongue can be easily adjusted to maintain a good fit.

After the submucosal tunnel is completely epithelialized, the fixation strip 2 is sheared, and the implant 1 implanted under the tongue mucosa is removed, that is, a submucosal tunnel is established on the tongue. This submucosal tunnel can be fitted with a tongue-back elastic traction device for the treatment of snoring or OSAHS.

Embodiment 4: Mosaic type implant for establishing sublingual submucosal tunnel of the present invention

Referring to Figures 4 to 4-5, an optimized implant for establishing a sublingual submucosal tunnel of the present invention is shown in the present embodiment, and the implant 1 and the fixing strip 2 are used. Medical silicone rubber is manufactured in its entirety. The implant 1 employs a smooth thin-walled tubular structure. The implant 1 includes a through hole 10, and a left side positioning step 11-1 and a right side positioning step 12-1 are respectively disposed at two ends of the implant 1. The strap 2 includes a strap 20 that is in contact with the mucosal surface of the tongue, which strap 20 is a smooth, flat strip-like structure. The proximal end of the fixing strap 2 is connected with the left end 11 of the implant body 1; the distal end of the fixing strap 2 is sequentially provided with a guiding head 21, a positioning block 22, and a strapping strap 20. The positioning block 22 of the fixing strap has an outer diameter matching the inner diameter of the through hole 10 of the implant 1 , and the positioning block 22 can be embedded in the through hole 10 of the implant 1 to form a fixed Connection, refer to Figure 4 to Figure 4-2.

The implant 1 is implanted behind the tongue, the fixing strap 2 bypasses the tongue tissue 3 above the implant 1 , and the guiding head 21 and the positioning block 22 on the fixing strap 2 are sequentially removed from the implant The right end 12 of the intrusion enters the through hole 10 and passes through the through hole 10, and the positioning block 22 of the fixing band 2 is embedded in the through hole 10 of the implant 1 such that the positioning block 22 The upper positioning projections 22-1 are caught at both ends of the implant 1 to form a closed connection between the implant 1 and the fixed strap 2, with reference to Figures 4-3. The fixation of the implant of the present invention on the tongue is accomplished by surgical shearing to the guide head 21, see Figures 4-4 and 4-5. Since the positioning block 22 on the fixing strap 2 is embedded in the through hole 10 of the implant 1, the protrusion which is in contact with the oral mucosa is reduced, and it is more comfortable to use.

After the submucosal tunnel is completely epithelialized, the fixation strip 2 is cut and disassembled. In addition to the implant 1 implanted under the mucosa of the tongue, a submucosal tunnel of the tongue is established on the tongue. This submucosal tunnel can be fitted with a tongue-back elastic traction device for the treatment of snoring or OSAHS.

It should be noted that the structures disclosed and illustrated herein may be replaced with other structures having the same effect, and the embodiments described herein are not the only structures that implement the invention. Although the preferred embodiments of the present invention have been described and illustrated herein, it will be apparent to those skilled in the art that Numerous variations, modifications, and substitutions may be made by those skilled in the art without departing from the invention, and the scope of the invention should be defined in accordance with the spirit of the invention and the scope of the claims.

1‧‧‧ implant

10‧‧‧through hole

11‧‧‧ Left end of the implant

11-1‧‧‧ Positioning step

12‧‧‧ right end of the implant

12-1‧‧‧ Positioning step

2‧‧‧Fixed tape

20‧‧‧ straps

23‧‧‧Positioning holes

3‧‧ ‧ tongue tissue

Claims (15)

An implant for establishing a sublingual submucosal tunnel, characterized in that the implant comprises an implant implanted on the back of the tongue, and at least one fixation strap; the implant is implanted behind the tongue The fixation strip is secured to the implant by a tongue tissue connection over the implant, forming a closed connection between the implant and the fixation strip. An implant for establishing a sublingual submucosal tunnel as described in claim 1 is characterized in that the implant is a thin-walled tubular having an arc corresponding to the submucosal tunnel to be established. Structure, or rod structure. An implant for establishing a sublingual submucosal tunnel according to claim 2, wherein the left end of the implant is provided with a left side positioning convex step; and the right end of the implant body is provided with a right side. Position the convex steps. An implant for establishing a sublingual submucosal tunnel as described in claim 2, wherein the thin-walled tubular structure of the implant comprises a through hole. An implant for establishing a sublingual submucosal tunnel according to the first aspect of the invention, characterized in that the fixing tape comprises a strapping tape in contact with a mucous membrane surface of the tongue, the strapping being a smooth strip. structure. An implant for establishing a sublingual submucosal tunnel according to claim 1, wherein the fixing strap comprises a guiding head and at least one positioning block, and the guiding head is disposed at a front end of the positioning block. . An implant for establishing a sublingual submucosal tunnel according to claim 6, wherein the positioning block has an inner diameter of the through hole of the implant. The outer diameter of the adapter is embedded in the through hole of the implant to form a fixed connection. The implant for establishing a sublingual submucosal tunnel according to claim 7 is characterized in that: the positioning block is provided with a positioning convex step, and the positioning convex step is stuck at the end of the implant body. unit. An implant for establishing a sublingual submucosal tunnel as described in claim 1 is characterized in that the fixing strip comprises a positioning hole. An implant for establishing a sublingual submucosal tunnel as described in claim 9 is characterized in that the positioning hole sleeve forms a closed fixed connection at the end of the implant. An implant for establishing a sublingual submucosal tunnel according to claim 9 is characterized in that: one end of the fixing strap is connected to one end of the implant; the implant is implanted behind the tongue After the other end of the fixing strap bypasses the tongue tissue above the implant, the positioning hole sleeve on the fixing strap forms a closed fixed connection at the other end of the implant. An implant for establishing a sublingual submucosal tunnel according to claim 9 is characterized in that: one end of the fixing strap is connected to one end of the implant; the implant is implanted behind the tongue After the other end of the fixing strap bypasses the tongue tissue above the implant, the positioning hole formed on the other end of the implant forms a closed fixed connection. An implant for establishing a sublingual submucosal tunnel according to claim 4, wherein one end of the fixing strap is connected to one end of the implant; the implant is implanted behind the tongue The other end of the strap is wrapped around the tongue above the implant After tissue, a closed, fixed connection is formed in the through hole of the implant. An implant for establishing a sublingual submucosal tunnel as described in claim 1 is characterized in that the implant is made of a medical material, and the fixed strap is made of a medical flexible material. The implant for establishing a sublingual submucosal tunnel according to claim 1, wherein the implant and the fixing strap are integrally manufactured by using a medical flexible material, and the medical flexible material is selected. A group of free medical silicone, medical polyurethane, medical rubber, medical latex and medical polyethylene.