WO2017005151A1

WO2017005151A1 - U-type drawbar for implanted tongue tractive device

Info

Publication number: WO2017005151A1
Application number: PCT/CN2016/088291
Authority: WO
Inventors: 周星; 张湘民
Original assignee: 周星
Priority date: 2015-07-05
Filing date: 2016-07-03
Publication date: 2017-01-12
Also published as: CN106308976A; CN106308976B

Abstract

A U-type drawbar (1) for an implanted tongue tractive device is of a U-shaped or C-shaped structure, and comprises a left arm (11), a right arm (12), a connection mechanism (13), and an enclosed locking mechanism (103). When the U-type drawbar (1) is implanted, the left arm (11) and the right arm (12) are in the state of opening. After the implantation, middle portions of the left arm (11) and the right arm (12) of the U-type drawbar (1) can be connected in a fastened manner by using the enclosed locking mechanism (103), to become a whole, thereby better drawing a tongue root portion.

Description

U-shaped traction plate for implantable tongue pulling device

Technical field

The present invention relates to a U-shaped traction plate for an implantable tongue pulling device, in particular for the implantation of Obstructive sleep apnea/hypopnea syndrome (OSAHS). U-shaped traction plate for tongue pulling device.

Background technique

Obstructive sleep apnea hypopnea syndrome (OSAHS) is a sleep-disordered disorder characterized by snoring, apnea, and hypopnea due to 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-and-root traction device in the Chinese patent application CN102198010A, which is an important component of the device, and the present patent application It is a further improvement of the traction plate in this patent application.

Summary of the invention

The U-shaped traction plate for implantable tongue pulling device of the present invention, the U-shaped traction plate 1 is a flat implant which can be implanted under the mucosa layer of the tongue, and has a structure for facilitating the growth of fibrous tissue. The through hole 101 and the traction wire fixing mechanism 102 are characterized in that:

The U-shaped traction plate 1 has a U-shaped or C-shaped structure, and includes a left arm 11, a right arm 12 and a connecting mechanism 13. The proximal ends of the left arm 11 and the right arm 12 are connected by a connecting mechanism 13, and the left arm 11 is connected. Separating from the distal end of the right arm 12;

The U-shaped traction plate 1 includes a closure locking mechanism 103;

When the U-shaped traction plate 1 is implanted, the left arm 11 and the right arm 12 are in an open state, and the left arm 11 and the right arm of the U-shaped traction plate 1 can be moved by the closing locking mechanism 103 after implantation. The arm 12 is closed.

The U-shaped traction plate 1 is connected to the left arm and the right arm 12 by the connecting mechanism 13 to form an integral body. In Before the implantation, the distal ends of the left arm 11 and the right arm 12 of the U-shaped traction plate 1 are in an open state, and after the implantation, the closing locking mechanism 103 is closed and locked by an external force, thereby realizing the U-shaped The left arm 11 and the right arm 12 of the traction plate 1 are closed. Since the left arm 11 and the right arm 12 of the U-shaped traction plate 1 are closed to form a whole, the U-shaped traction plate 1 is integrally stressed during the pulling process, and is not due to the left arm 11 and the right. The force of the arms 12 is inconsistent and the left arm 11 and the right arm 12 of the U-shaped traction plate are misaligned, so that the plane pulling effect of the tongue can be better achieved.

The closure locking mechanism 103 is a concave-convex card engagement mechanism. The closing locking mechanism 103 includes a positioning groove 103-0 and a positioning convex step 103-1. When closing, the positioning convex step 103-1 is inserted into the positioning groove 103-0, which can be conveniently realized. The closing of the left arm 11 and the right arm 12 of the U-shaped traction plate is described.

The closure locking mechanism 103 is an interference fit structure.

The closure locking mechanism 103 is a riveted structure.

The closure locking mechanism 103 is a threaded structure.

After the left arm 11 and the right arm 12 of the U-shaped traction plate 1 are closed, the gap L between the left arm 11 and the right arm 12 is less than 5 mm.

Further, the connection mechanism 13 of the U-shaped traction plate 1 is a hinge mechanism 131. The hinge mechanism 131 includes a through hole 131-0 and a pin 131-1; a through hole 131-0 is disposed on the proximal end of the left arm 11 and the right arm 12, and the pin 131-1 is sequentially worn. After the through holes 131-0 on the left arm 11 and the right arm 12, the proximal ends of the left arm 11 and the right arm 12 are movably coupled together, the left arm 11 and the right The arm 12 can be opened or closed about the pin 131-1.

The U-shaped traction plate 1 is integrally manufactured using medical materials.

The U-shaped traction plate 1 can be made of medical metal material or medical polymer material.

The U-shaped traction plate 1 for an implantable tongue pulling device of the present invention has a U-shaped or C-shaped structure, and includes a left arm 11, a right arm 12, and a coupling mechanism 13 and a closure locking mechanism 103. When the U-shaped traction plate 1 is implanted, the left arm 11 and the right arm 12 are in an open state, and the left arm 11 and the right arm of the U-shaped traction plate 1 can be moved by the closing locking mechanism 103 after implantation. The middle portion of the arm 12 is fixedly attached to form a unitary body for better pulling of the base of the tongue.

DRAWINGS

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a perspective view showing the structure of a U-shaped traction plate of the present invention in an open state.

Figure 1-1 is a schematic perspective view of the structure of Figure 1 when closed.

Figure 1-2 is a front view of Figure 1.

Figures 1-3 are side views of Figures 1-2.

1-4 are front views of Fig. 1-1.

1-5 is a cross-sectional view taken along line A-A of Fig. 1-2.

Figure 1-6 is a cross-sectional view taken along line B-B of Figure 1-4.

2 is a schematic perspective view showing the hinged U-shaped traction plate of the present invention in an open state.

Figure 2-1 is a schematic view of the structure of Figure 2 when closed.

2-2 is a cross-sectional view taken along line C-C of Fig. 2.

Fig. 3 is a structural schematic view showing the closing locking mechanism of the U-shaped traction plate of the present invention adopting an interference fit structure.

Fig. 4 is a structural schematic view showing the closing and locking mechanism of the U-shaped traction plate of the present invention using a riveted structure.

Fig. 5 is a structural schematic view showing a state in which the closing and locking mechanism of the U-shaped traction plate of the present invention adopts a threaded structure.

Figure 6 is a schematic view showing the operation of the U-shaped traction plate of the present invention.

In the above picture:

1 is a U-shaped traction plate for an implant type tongue pulling device of the present invention, 101 is a through hole for facilitating fibrous tissue growth on the traction plate, 102 is a traction wire fixing mechanism on the traction plate, and 103 is a traction plate. The closing locking mechanism; 103-0 is a positioning groove of the concave-convex card-fit type closed locking mechanism, 103-1 is a positioning convex step of the concave-convex card-fit type closed locking mechanism, and 103-2 is a positioning of the interference fit type closed locking mechanism Hole, 103-3 is the positioning block of the interference fit type closed locking mechanism, 103-4 is the through hole of the middle part of the left arm and the right arm of the riveting type closed locking mechanism, and 103-5 is the positioning pin of the riveting type closed locking mechanism or Rivets, 103-6 are threaded holes in the middle of the left and right arms of the threaded closure locking mechanism, and 103-7 is a set screw for the threaded closure locking mechanism.

11 is the left arm of the U-shaped traction plate, 12 is the right arm of the U-shaped traction plate, 13 is the connection mechanism; 131 is the hinge connection mechanism, 131-0 is the through hole of the hinge connection mechanism, and 131-1 is the hinge type The pin of the connecting mechanism.

L is a gap between the left arm 11 and the right arm 12.

detailed description

Example 1: U-shaped traction plate integrally manufactured by the present invention

Referring to FIG. 1 to FIG. 1-5, in the present embodiment, a U-shaped traction plate for an implant type tongue pulling device of the present invention is integrally manufactured by a machining process using medical titanium metal.

In this embodiment, the U-shaped traction plate 1 for the implantable tongue pulling device can be implanted under the tongue mucosa layer. A flat implant having a through hole 101 for facilitating the growth of fibrous tissue and a traction wire fixing mechanism 102.

The U-shaped traction plate 1 has a U-shaped or C-shaped structure. The U-shaped traction plate 1 includes a left arm 11, a right arm 12, and a coupling mechanism 13. The proximal ends of the left arm 11 and the right arm 12 are connected by a connecting mechanism 13, and the distal ends of the left arm 11 and the right arm 12 are separated, and have a U-shaped or C-shaped shape that is open at the distal end. The distal ends of the left arm 11 and the right arm 12 are tapered with a guiding function.

Furthermore, the U-shaped traction plate 1 further comprises a closure locking mechanism 103. In this embodiment, the closing locking mechanism 103 is a concave-convex card fitting structure, and the closing locking mechanism 103 includes a positioning groove 103-0 and a positioning convex step 103-1. When the U-shaped traction plate 1 is closed, the positioning convex step 103-1 is embedded in the positioning groove 103-0 to constitute the closed locking mechanism 103, and the left arm 11 of the U-shaped traction plate and The middle of the right arm 12 is connected and fixed together. The positioning protrusion 103-1 and the positioning groove 103-0 are tapered or wedge-shaped with a puncture function.

When the U-shaped traction plate 1 is implanted, the left arm 11 and the right arm 12 are in an open state; after implantation, the connection mechanism 13 is plastically deformed by the clamping action of the closing clamp, the positioning The convex step 103-1 is embedded in the positioning groove 103-0, and the middle portion of the left arm 11 and the right arm 12 of the U-shaped traction plate are connected and fixed together by the connecting mechanism 13 of the concave-convex card matching structure. The left arm 11 and the right arm 12 of the U-shaped traction plate are closed. The gap L between the left arm 11 and the right arm 12 of the closed U-shaped traction plate is less than 5 mm.

In clinical use, before implantation, the left arm 11 and the right arm 12 of the U-shaped traction plate of the present invention are kept open under the action of the connecting mechanism 13, and are cut in front of the tongue nipple with a needle-shaped electric knife at the back of the tongue. The mucosa is opened and separated under the mucosa to the base of the tongue, so that the left arm 11 and the right arm 12 of the U-shaped traction plate are inserted along both sides of the lingual septum, and the traction plate 1 is implanted in the back of the human tongue and/or Or in the muscular layer under the mucosa of the base of the tongue. After the implantation, the closing locking mechanism 103 is closed and locked by an external force, so that the connecting mechanism 13 of the U-shaped traction plate is plastically deformed, and the positioning convex step 103-1 and the positioning groove 103-0 are formed. After piercing the lingual fascia of the tongue, the positioning protrusion 103-1 is embedded in the positioning groove 103-0; the left arm 11 of the U-shaped traction plate is connected by the connecting mechanism 13 of the concave-convex card fitting structure The central portion of the right arm 12 is coupled and fixed together to effect closure of the left arm 11 and the right arm 12 of the U-shaped traction plate. Since the positioning convex step 103-1 is caught in the positioning groove 103-0, the left arm 11 and the right arm 12 of the U-shaped traction plate 1 are formed by piercing the tough tongue septum fascia at the intermediate portion. Connecting; the left arm 11 and the right arm 12 of the U-shaped traction plate 1 not only form a whole body, but also have a tough tongue septal fascia; therefore, the U-shaped traction plate 1 is integrally stressed during the tongue pulling process. The displacement of the left arm 11 and the right arm 12 of the U-shaped traction plate may not be caused by the inconsistent force of the left arm 11 and the right arm 12, so that the overall pulling of the tongue root tissue can be better achieved. Figure 6

In the present embodiment, a closed locking mechanism 103 of a concave-convex card fitting structure is exemplified. In addition, the closing locking mechanism 103 can also achieve the closing of the left arm 11 and the right arm 12 of the U-shaped traction plate 1 by other means such as an interference fit, a riveted connection and a screw connection, without departing from the scope of protection of the present invention. .

Referring to FIG. 3, in the embodiment, the closing locking mechanism 103 employs an interference fit mechanism including a positioning hole 103-2 and a positioning block 103-3, and the positioning block 103-3 is embedded in In the positioning hole 103-2, an interference fit structure is formed to achieve the purpose of locking and fixing.

Referring to FIG. 4, in the embodiment, the closing locking mechanism 103 employs a riveting structure, and a through hole 103-4 is provided in a middle portion of the left arm 11 and the right arm 12 of the U-shaped pulling plate 1 at After the left arm 11 and the right arm 12 are closed, the positioning pin or rivet 103-5 passes through the through hole 103-4 of the middle of the left arm 11 and the right arm 12, and the left arm 11 and the right arm 12 are locked. Tightly fixed.

Referring to FIG. 5, in the embodiment, the closing locking mechanism 103 adopts a screw connection structure, and a screw hole 103-6 is provided in a middle portion of the left arm 11 and the right arm 12 of the U-shaped traction plate 1. After the closing of the left arm 11 and the right arm 12, the positioning screw 103-7 passes through the threaded holes 103-6 in the middle of the left arm 11 and the right arm 12, and the left arm 11 and the right arm 12 are locked. fixed.

Embodiment 2: Hinged U-shaped traction plate of the present invention

Referring to FIGS. 2 to 2-2, the present embodiment differs from the first embodiment in that the connecting mechanism 13 of the U-shaped traction plate 1 is a hinge mechanism 131. The hinge mechanism 131 includes a through hole 131-0 and a pin 131-1; a through hole 131-0 is disposed on the proximal end of the left arm 11 and the right arm 12, and the pin 131-1 is sequentially worn. After the through holes 131-0 on the left arm 11 and the right arm 12, the proximal ends of the left arm 11 and the right arm 12 are movably coupled together, the left arm 11 and the right The arm 12 can be opened or closed about the pin 131-1.

The advantage of the hinged U-shaped traction plate is that the closing force required to close the forceps is relatively small when the left arm 11 and the right arm 12 are closed, and the clinical operation is more convenient.

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 these embodiments are merely illustrative and that numerous changes and modifications can be made by those skilled in the art. The scope of the present invention is defined by the spirit and scope of the appended claims.

Claims

U-shaped traction plate for implantable tongue pulling device, the U-shaped traction plate (1) is a flat implant that can be implanted under the mucosa layer of the tongue, and has a pass for facilitating the growth of fibrous tissue The hole (101) and the traction wire fixing mechanism (102) are characterized in that:

A. The U-shaped traction plate (1) has a U-shaped or C-shaped structure, and includes a left arm (11), a right arm (12) and a connecting mechanism (13), and the left arm (11) and the right arm (12) The proximal end of the second arm (11) and the right arm (12) are separated by a connection mechanism (13);

B, the U-shaped traction plate (1) comprises a closed locking mechanism (103);

C. When the U-shaped traction plate (1) is implanted, the left arm (11) and the right arm (12) are in an open state, and the U can be inserted through the closed locking mechanism (103) after implantation. The left arm (11) and the right arm (12) of the type traction plate (1) are closed.
A U-shaped traction plate for an implantable tongue pulling device according to claim 1, wherein said closure locking mechanism (103) is a concave-convex card engagement mechanism.
A U-shaped traction plate for an implantable tongue pulling device according to claim 1, wherein said closure locking mechanism (103) is an interference fit structure.
A U-shaped traction plate for an implantable tongue pulling device according to claim 1, wherein said closure locking mechanism (103) is a riveted structure.
A U-shaped traction plate for an implantable tongue pulling device according to claim 1, wherein said closure locking mechanism (103) is a threaded structure.
The U-shaped traction plate for an implantable tongue pulling device according to claim 1, wherein the left arm (11) and the right arm (12) of the U-shaped traction plate (1) are closed, The gap L between the left arm (11) and the right arm (12) is less than 5 mm.
The U-shaped traction plate for an implantable tongue pulling device according to claim 1, wherein the connection mechanism (13) of the U-shaped traction plate (1) is a hinge mechanism (131), The hinge mechanism (131) includes a through hole (131-0) and a pin (131-1); and a through hole (131-0) is formed on the proximal end of the left arm (11) and the right arm (12) After the pin (131-1) sequentially passes through the through holes (131-0) on the left arm (11) and the right arm (12), the left arm (11) and the right arm are The proximal ends of (12) are movably coupled together, and the left arm (11) and the right arm (12) are capable of an open or closed motion about the pin (131-1).
A U-shaped traction plate for an implantable tongue pulling device according to claim 1, wherein said U-shaped traction plate (1) is made of a medical material.
The U-shaped traction plate for implantable tongue pulling device according to claim 1, characterized in that the U-shaped traction plate (1) can be made of medical metal material or medical polymer material.