Implanted tongue pulling device, pull plate, pull line, retractor and method
09724229 · 2017-08-08
Assignee
Inventors
Cpc classification
A61B2017/248
HUMAN NECESSITIES
A61F2/00
HUMAN NECESSITIES
International classification
A61F2/00
HUMAN NECESSITIES
Abstract
An implanted tongue pulling device including a pull plate, a pull line, a retractor and a method thereof are provided. The tongue pulling device is implanted in the mandible and tongue of a human body, respectively, for tightening the tongue dorsum and/or the tongue base for treating obstructive sleep apnea/hypopnea syndrome (OSAHS). At least three pull lines are used for positioning the pull plate, which is a flat object implanted beneath the tongue dorsum and/or the mucous membrane of the tongue base and includes through holes for the growth of tissues and pull line fixing mechanisms. The pull line includes a draw line and a sleeve. The retractor includes a casing, a control switch and a pull line fixing device mounted on the casing. A patient after surgery can adjust the tightening extent of the implanted tongue pulling device by pressing the skin outside the control switch, thereby preventing OSAHS.
Claims
1. An implantable tongue pulling device, configured to be implanted into a mandible and a tongue body of a human being to tighten a tongue dorsum and/or a tongue base of the human being, comprising: a pull plate, wherein the pull plate is an implant capable of being implanted under a mucous membrane layer of the tongue body, and includes one or more through holes for facilitating growth of fibrous tissues and pull line fixing mechanisms; a pull line, wherein the pull line is a thread made of a material capable of being implanted into the human being; and a retractor, the retractor including a control switch capable of adjusting a tension of the pull line, a pull line fixing device capable of fixing the pull line, and a casing, wherein the control switch and the pull line fixing device are mounted in the casing, the control switch comprising a tightening switch, a loosening switch, and a ratchet, wherein: pressing the tightening switch causes the ratchet to rotate, thereby driving the pull line fixing device to tighten the pull line, pressing the loosening switch causes the ratchet to be released, thereby driving the pull line fixing device to loosen the pull line, and the pull line has a first end connected to the pull plate and a second end connected to the retractor.
2. The tongue pulling device of claim 1, wherein a distance between the pull plate and the retractor is reduced by 5 mm to 20 mm due to a pulling of the pull line; and a pressure generated on the pull plate due to the reduction of the distance between the pull plate and the retractor is between 50 g/cm.sup.2 and 1000 g/cm.sup.2.
3. The tongue pulling device of claim 1, wherein there are at least three pull lines, and each of the pull lines has a respective first end connected to the retractor and a respective second end connected to a corresponding one of at least three pull line fixing mechanisms of the pull plate that are at different positions, so as to spatially position the pull plate.
4. The tongue pulling device of claim 3, wherein the pull line fixing mechanisms include one selected from the group consisting of a plurality of through holes for winding, binding or fixing the pull lines; catch-slot or concave-convex engagement mechanisms for fixing the plurality of pull lines; or rivet fastening mechanisms or thread fastening mechanisms capable of fixing the pull lines.
5. The tongue pulling device of claim 1, wherein the pull plate includes a frame and medical films wrapped on the frame.
6. The tongue pulling device of claim 5, wherein the frame of the pull plate is a mesh formed by braided elastic wires, and the elastic wires are capable of moving in a gap between the medical films.
7. The tongue pulling device of claim 1, wherein the pull plate has a curved surface matching with a shape of the tongue dorsum portion and/or the tongue base portion of the human being, and the curved surface has a shape selected from the group consisting of a rectangle, a square, a trapezoid, a circle, an ellipse, a V-shape, a U-shape and an H-shape.
8. The tongue pulling device of claim 1, wherein the pull plate further comprises a left-side pull plate and a right-side pull plate; the left-side pull plate and the right-side pull plate are assembled together through a mechanical connection mechanism; and a gap and junction are formed between the left-side pull plate and the right-side pull plate.
9. The tongue pulling device of claim 8, wherein the gap has a width between 2 mm and 5 mm and a length between 5 mm and 15 mm.
10. The tongue pulling device of claim 8, wherein the mechanical connection mechanism is a mechanical fixing mechanism capable of fixing two metal plates, and the mechanical connection mechanism is selected from a group consisting of a rivet structure, a concave-convex engagement structure, and a thread fixing structure.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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(113) FIG. 27E1 is an enlarged view of part M of
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(139) The Meanings of the Serial Numbers in the Above Drawings are as Follows:
(140) 1. pull plate, 2. pull line, 3. retractor, 4. tongue, 5. mandible, 6. soft palate, 7. lower lip, 8. skin, 9. screwdriver, 10. Screw, 11. human tissues, 12. hyoid hone, 13. special surgical forceps, 41. tongue base, 42. tongue dorsum, 51. front portion of mandible, 52. bottom portion of mandible
(141) 101. through hole for facilitating growth of fibrous tissues, 102. pull line fixing mechanism, 103. frame of pull plate, 104. medical film, 105. gap between the films, 106. bonded part or bonded edge, 107. coating for improving biocompatibility, 108. U-shaped node
(142) 102A. small bump, 102B. small groove, 102C. rivet fastening mechanism, 102D. thread fastening mechanism
(143) 103A. position of frame before movement, 103B. position of frame after movement, 103C. elastic wire
(144) 109A. left-side pull plate, 109B. right-side pull plate, 109C. gap between left-side pull plate and the right-side pull plate, 109D. junction between the left-side pull plate and the right-side pull plate, 109E. mechanical connection mechanism, 109E1. rivet, 109E2. rivet base, 109E3. lock nut for concave-convex engagement, 109E4. lock screw for concave-convex engagement
(145) H109. maximum width of the gap between left-side pull plate and the right-side pull plate, L109. maximum length of the gap between the left-side pull plate and the right-side pull plate
(146) 201. draw line, 202. Sleeve, 202A. inner layer, 202B. outer layer, 203. bead
(147) 301. control switch, 302. pull line fixing device, 303. anti-cutting buffer device, 304. retractor casing, 305. restoring spring, 306. protective sheath
(148) 301A. positioning convex step of control switch, 301B. positioning concave groove of control switch, 301C. tightening switch, 301D. loosening switch, 301E. spring, 301F. adjustment handle, 301G. spring positioning post, 301A1. convex gear, 301B1. concave gear, wedge-shaped slide block (301A1) on the tightening switch, spring (301E1) on the tightening switch, wedge-shaped slide block (301A2) on the tightening switch, the spring (301E2) on the tightening switch, 301B2. ratchet, 301B3. tooth rack
(149) 302A. thread hole, 302B. positioning slot, 302C. binding plate, 302D. spring positioning post, 302E. positioning convex step, 302F. positioning convex step connected to 301, 302G. positioning convex step connected to 301, 302H. spring, 302I. pull line fixing bolt, 302J. internal thread, 302L. bobbin, 302M. positioning slide block, 302M1. positioning slide-block cover
(150) 304A. thread hole, 304B. seal ring, 304C. screw hole, 304D. silica gel plug, 304E. positioning convex step, 304F. positioning concave groove, 304G. top cover, 304H. bottom cover of the casing, 3041. nut, 304J. screw, 304K. silica gel film, 304L. main body, 304M. side surface of the casing, 304N. side hole, 304P. positioning slot opening, 304B1. top cover seal ring, fixing plate (304B2) of the top cover seal ring, 304L1. casing side plate, 304A1. through hole (304A1) on the nut
(151) 305A. fixed head of restoring spring, 305B. positioning slot for the fixed head of restoring spring
(152) C. clearance, H. height, H1. height, R. radian, T. thickness, W. width, φ. diameter of through hole
DETAILED DESCRIPTION OF THE INVENTION
Embodiment 1
A Tongue Pulling Device of the Present Invention
(153) Referring to
(154) The tongue pulling device of the present invention includes a pull plate (1), a pull line (2), and a retractor (3). The pull plate (1) is a flat implant capable of being implanted under the mucous membrane layer of the tongue base portion and/or the tongue dorsum portion of a human body, and includes through holes (101) allowing growth and penetration of human tissues and pull line fixing mechanisms (102). The pull line (2) is a thread made of a material capable of being implanted into the human body for a long term. The retractor (3) includes a control switch (301) capable of adjusting a tension of the pull line (2), a pull line fixing mechanism (302), and a casing (304). The pull line (2) has one end connected to the pull plate (1) and the other end connected to the retractor (3).
(155) In this embodiment, the pull plate (1) is implanted into the muscular layer under the mucous membrane layer of the tongue dorsum portion. The retractor (3) is fixed to the mandible (5) by using a screw (10).
(156) In this embodiment, the pull line fixing mechanisms (102) are through holes for winding and fixing the pull line (2).
(157) In this embodiment, the pull plate (1) is retracted by using a four-line four-corner spatial positioning method, that is, by using four pull lines (2), where one end of each of the four pull lines is fixed to a corresponding one of the pull line fixing mechanisms (102) at four corners of the pull plate (1), and the other end of each of the four pull lines is passed through the protective sheath (306) and fixed to the retractor (3), so as to achieve three-dimensional fixing.
(158) Since the pull plate (1) has a spatial curved surface matching with the shape of the tongue base portion and/or the tongue dorsum portion, the tongue body is retracted in a surface contact manner, so that the pressure generated by retracting the tongue base portion and/or the tongue dorsum portion is greatly reduced, thereby preventing the pull plate (1) from cutting the tongue muscles under long-term alternate tensions. The pressure generated by the tension on the pull plate (1) may be smaller than 1000 g/cm.sup.2, for example, under a tension of 3000 g, if the pressure generated by the tension on the pull plate (1) needs to be smaller than 500 g/cm.sup.2, the area of the pull plate (1) only needs to be larger than 6 cm.sup.2, that is, the pull plate (1) only needs to be a 25 mm×25 mm square.
(159) After the tongue pulling device of the present invention is implanted through surgery, the patient can adjust the pulling degree of the tongue pulling device of the present invention to the tongue base portion and/or the tongue dorsum portion under the instruction of the doctor, so as to achieve maximum comfort, as shown in
(160) Particularly, in a non-sleep state, the control switch (301) is pressed from a position outside the skin (8) of the mandible to loosen the pull lines (2), so as to increase the length of the pull lines (2) between the pull plate (1) and the retractor (3), so that the pull lines (2) apply a small pulling force to the tongue base portion and/or the tongue dorsum portion or are completely in a loosened state, and at this time, the movement of the tongue is almost unconstrained, and the tongue is capable of moving freely during speaking, swallowing and other activities, thereby ensuring free movement of the tongue during speaking, swallowing and other activities.
(161) Before sleep, the control switch (301) is pressed from the position outside the skin (8) of the mandible to tighten the pull lines (2), so as to reduce the length of the pull lines (2) between the pull plate (1) and the retractor (3), and at this time, the pull line (2) applies a large pulling force to the tongue base portion and/or the tongue dorsum portion, the tongue base portion and/or the tongue dorsum portion is in an effective retracted state, and the tongue base portion and/or the tongue dorsum portion is pulled forward, so as to maintain the palatopharyngeal portion open, thereby preventing OSAHS.
(162) A degree of comfort may also be set for the tongue pulling device of the present invention. To avoid daily adjustment, the control switch (301) may be adjusted so that the pull line (2) applies a proper pulling force to the tongue base portion and/or the tongue dorsum portion, so as to move the tongue base portion and/or the tongue dorsum portion forward while ensuring comfort during movement of the tongue, and maintain the palatopharyngeal portion open, thereby preventing OSAHS.
Embodiment 2
A Tongue Pulling Device Having a Rectangular Pull Plate of the Present Invention
(163) Referring to
(164) Main dimensions of the rectangular pull plate (1) include:
(165) a radian R of the curved surface being 10 mm to 120 mm, and preferably 20 mm to 50 mm;
(166) a width W of the curved surface being 10 mm to 50 mm, and preferably 15 mm to 30 mm;
(167) a height H of the curved surface being 10 mm to 50 mm, and preferably 20 mm to 35 mm;
(168) a thickness T of the plate being 0.1 mm to 1 mm, and preferably 0.4 mm to 0.8 mm; and
(169) a diameter φ of the through hole (101) being 0.1 mm to 4 mm, and preferably 0.5 mm to 2 mm.
(170) Typical dimensions (width×height) include: 15 mm×20 mm, 18 mm×25 mm, 20 mm×30 mm, 25 mm×35 mm, 30 mm×35 mm, 35 mm×35 mm, 35 mm×40 mm, 40 mm×40 mm and the like.
(171) The pull plate (1) is made of a material selected from a group consisting of, but not limited to: medical metal materials, medical polymer materials, medical composite materials, metal amorphous materials (also referred to as metallic glass) for medical use, and various modified coating materials. Specific materials are generally selected from a group consisting of:
(172) medical grade pure titanium, medical grade titanium alloy, Ti—Zr—Ta alloy, Co—Cr—W alloy, titanium-nickel shape memory alloy (Nitinol alloy), Ti-based amorphous materials, Zr-based amorphous materials, Fe-based amorphous materials, medical grade stainless steel (such as 316L), various medical grade titanium and titanium alloy with an amorphous material coating and medical grade stainless steel with an amorphous material coating, and the like.
(173) Medical grade PA, medical grade PC, medical grade PE, medical grade PU, medical grade PP, medical grade polytetrafluoroethylene and other medical polymer materials and fiber reinforced composite materials.
Embodiment 3
A Tongue Pulling Device Using Two Pull Plates of the Present Invention
(174) Referring to
Embodiment 4
A Tongue Pulling Device Having a U-Shaped Pull Plate of the Present Invention
(175) Referring to
(176) Main dimensions of the U-shaped pull plate (1) include:
(177) a radian R of the curved surface being 10 mm to 120 mm, and preferably 20 mm to 50 mm;
(178) a width W of the curved surface being 10 mm to 50 mm, and preferably 15 mm to 30 mm;
(179) a height H of the curved surface being 10 mm to 50 mm, and preferably 20 mm to 35 mm;
(180) a height H1 being 5 mm to 20 mm, and preferably 5 mm to 15 mm;
(181) a clearance C of the curved surface being 6 mm to 15 mm, and preferably 5 mm to 10 mm;
(182) a thickness T of the plate being 0.1 mm to 1 mm, and preferably 0.4 mm to 0.8 mm; and
(183) a diameter φ of the through hole (101) being 0.1 mm to 4 mm, and preferably 0.5 mm to 3 mm.
(184) The U-shaped pull plate (1) is generally made of a medical metal material, particularly, medical grade pure titanium, medical grade titanium alloy, Ti—Zr—Ta alloy, Co—Cr—W alloy, a Ti-based amorphous material, a Zr-based amorphous material, a Fe-based amorphous materials, medical grade stainless steel (such as 316L), medical grade stainless steel with an amorphous material coating, or the like.
Embodiment 5
A Tongue Pulling Device Having a Coating of the Present Invention
(185) Referring to
(186) Embodiment 2 shown in
(187) Particularly, the coating (107) on the surface of the pull plate (1) may be manufactured into a Ti-based amorphous coating by magnetron sputtering. The Ti-based amorphous coating has excellent biocompatibility, and can form a firm bond with human tissues.
Embodiment 6
A Tongue Pulling Device Having an H-Shaped Pull Plate of the Present Invention
(188) Referring to
(189) Moreover, the pull plate (1) is made of a medical polymer material.
(190) Since the medical polymer material has a lower specific gravity than that of a medical metal material, the pull plate (1) made of the medical polymer material is lighter, and is more suitable for being implanted into the tongue dorsum portion and/or the tongue base portion.
(191) The medical polymer material is generally selected from a group consisting of: materials such as polyamide (PA), polycarbonate (PC), polyurethane (PU), polythylene/polythene (PE), polypropylene (PP) and medical grade polytetrafluoroethylene, and fiber reinforced composite materials such as fiber reinforced PC, fiber reinforced PE, fiber reinforced PU, fiber reinforced PP and fiber reinforced PA.
Embodiment 7
A Tongue Pulling Device Having a V-Shaped Pull Plate of the Present Invention
(192) Referring to
(193) Three-line positioning method. In this embodiment, the three-line positioning method is adopted, that is, three pull lines (2) are used to spatially position the pull plate (1). One of the pull lines (2) is bound to the through hole that serves as the pull line fixing mechanism (102) at the top of the V-shaped pull plate (1), and the other two pull lines (2) are respectively bound to the two through holes that serve as the pull line fixing mechanisms (102) at the bottom of the V-shaped pull plate (1); the other end of each of the three pull lines (2) is fixed to the retractor (3), so as to spatially position the pull plate (1).
(194) The pull plate (1) may be made of a high-strength medical polymer fiber braid. The high-strength polymer fiber braid is, for example, polypropylene fiber braided fabric, which not only has high strength, but also is light in weight, and therefore is suitable for manufacturing the pull plate (1). In this embodiment, the pull plate (1) is made of the polypropylene fiber braided fabric. The fiber braided fabric has many tiny holes, which may function as the tiny through holes (101) for facilitating growth of tissues, and it only needs to form through holes as the pull line fixing mechanisms (102).
(195) Different Structural Designs of the Pull Line Fixing Mechanisms (102)
(196) Referring to
(197) The most common structure of the pull line fixing mechanisms (102) is a through hole structure, which not only facilitates winding the pull lines, but also facilitates binding and fixing the pull lines. Referring to
(198) Referring to
(199) Referring to
(200) Referring to
(201) The pull line fixing mechanisms (102) of many other different specific structures may also be designed according to the technical solution provided by the present invention.
Embodiment 8
A Pull Plate Having a Composite Structure of the Present Invention
(202) Referring to
(203) The pull plate (1) includes a frame (103) and medical films (104), and the medical films (104) are wrapped on the frame (103). In this embodiment, the frame (103) may be made of a plate. The material of the frame (103) includes, but is not limited to, medial metal materials such as titanium and titanium alloy and medical grade stainless steel, amorphous materials, and medical polymer materials (such as PC and PE); the frame (103) is formed by mechanical processing or wire electro-discharge machining or laser cutting, and hollowing out a plate into a skeleton-like structure.
(204) The medical films (104) are made of a material selected from a group consisting of, but not limited to: a polypropylene fiber braided fabric, a polytetrafluoroethylene film, a polyurethane film and other materials capable of being implanted into the human body for a long term.
(205) The formed medical films (104) are wrapped on the frame (103). The medical films (104) may be wrapped on the frame (103) by thermal bonding, sewing, or chemical adhesive bonding. After the medical films (104) are wrapped on the frame (103), through holes (101) for facilitating growth of tongue tissues and pull line fixing mechanisms (102) are formed thereon, thereby obtaining the pull plate (1) having a composite structure of the present invention.
(206) The medical films (104) may also be directly attached to the frame (103). A special wrapping manner is to bond the medical films (104) together at the hollow part of the frame (103) by thermal bonding, sewing, or chemical adhesive bonding, where the bonded part is referred to as a bonded edge (106). A gap (105) is formed between the two layers of film. The frame (103) is capable of moving freely in the gap (105). Such a composite structure has good adaptability to movement, and can meet the requirements of different movements of the tongue.
Embodiment 9
A Pull Plate Having a Wire-Braided Composite Structure of the Present Invention
(207) Referring to
(208) The elastic wire is selected from a group consisting of, but not limited to: medical grade elastic stainless steel, medical grade titanium-nickel shape memory alloy (Nitinol alloy) wires, Ti—Zr—Ta elastic alloy wires, metallic glass wires and the like, which may also be replaced with elastic polymer material wires such as highly elastic nylon wires.
(209) The braiding manner of the elastic wires is characterized in that an upper row of wires is connected to a lower row of wires through a U-shaped node (108).
(210) Such an elastic wire mesh formed by braiding through the U-shaped node (108) has good adaptability to movement, and can slide within a certain range in the vertical and horizontal directions, that is, move in the Y direction and X direction as shown in
(211) Such a braided wire mesh is used as the frame (103), which is wrapped by the medical films (104). At the hollow part of the frame (103), the medical films (104) are bonded together to form a bonded edge (106) by thermal bonding, sewing, or chemical adhesive bonding. The frame (103) formed by the elastic wires is freely placed in the gap (105) formed between the bonded edge (106) and the two layers of medical film (104). Through holes (101) for facilitating growth of tongue tissues and pull line fixing mechanisms (102) are formed at proper positions on the medical films (104), thereby obtaining the pull plate (1) having a wire-braided composite structure of the present invention.
(212) Since human tissues can be attached to and grow on the medical films (104), or penetrate and grow along the through holes (101), but cannot penetrate into the gap (105) between the films, it is ensured that the frame (103) formed by the elastic wires (103C) can move freely in the gap (105) between the films. Therefore, such a pull plate (1) having a wire-braided composite structure has excellent adaptability to movement, and can meet the requirements of different movements of muscle groups in the tongue, thereby improving the comfort when the tongue dorsum portion and/or the tongue base portion is retracted.
Embodiment 10
A Composite Pull Line of the Present Invention
(213) Referring to
(214) Pull Line Having a Composite Structure
(215) Since the tongue pulling device of the present invention can be adjusted after surgery, in the non-sleep state, the control switch (301) is adjusted to an “off” state, and at this time, the tongue base portion receives a small pulling force or is completely in a loosened state, thereby ensuring free movement of the tongue during speaking, swallowing and other activities; before sleep, the control switch (301) is adjusted to an “on” state, and at this time, the tongue base portion receives a large pulling force, or the tongue base portion is in an effective retracted state, so as to maintain the palatopharyngeal portion open, thereby preventing OSAHS. In this way, the pull line (2) has a relative movement in the soft tissues of the tongue. To reduce the cutting effect caused by the relative movement of the pull line (2) in the soft tissues of the tongue, the present invention particularly provides a pull line having a composite structure.
(216) Such a pull line (2) having a composite structure includes a draw line (201) and a protective sheath (202). The draw line (201) is a flexible line made of a high-strength medical material, and is generally made of a non-absorbable surgical suture. The protective sheath (202) is a hollow hose made of a flexible medical material. The protective sheath (202) is sleeved over the draw line (201), and the draw line (201) is capable of moving axially in the protective sheath (202), as shown in
(217) The protective sheath (202) is an elastic medical hose, for example, a medical silica gel tube, a medical polyurethane tube, an elastic fiber tube braided by synthetic fibers such as a polypropylene fiber braided tube, or the like. Among others, a composite tube having a multi-layer structure has a good effect, for example, a composite tube having an inner layer (202A) being a polyurethane thin wall tube and an outer layer (202B) being an elastic fiber tube braided by synthetic fibers. The outer layer (202) being an elastic fiber tube braided by synthetic fibers has many tiny holes which facilitate growth and penetration of human tissues so as to enhance the bonding strength. The inner layer (202A) being a polyurethane thin wall tube is smooth and has a small friction resistance, and particularly, is ultra-smooth in the presence of water, facilitating movement of the draw line (201) in the inner layer (202A), as shown in
(218) The draw line (201) is generally made of a non-absorbable medical thread. The most commonly used is a non-absorbable surgical suture, including, but not limited to, metal lines, natural fiber lines, synthetic fiber lines (such as polyester lines, polyamide lines, and polypropylene lines) and the like.
(219) The diameter of the draw line (201) is 0.3 mm to 1.3 mm, and preferably 0.35 mm to 0.6 mm.
(220) The inner diameter of the protective sheath (202) is 0.4 mm to 1.5 mm, and preferably 0.4 mm to 1.0 mm.
(221) Since the pull line (2) adopts the composite structure of the draw line (201) and the protective sheath (202), not only movement of the pull line (2) in human tissues is ensured, but also attachment and growth of human tissues on the pull line (2) are facilitated, thereby preventing the pull line (2) from cutting the tongue tissues during reciprocating movement. The pull line (2) forms a tunnel in the tongue tissues along the protective sheath (202), and the draw line (201) is capable of moving in the protective sheath (202) at a low friction force; the tongue tissues of the human body are capable of being attached to and growing along the outer wall of the protective sheath (202), thereby maintaining good bonding strength, as shown in
Embodiment 11
A Retractor of a Bolt Adjustment Type of the Present Invention
(222) Referring to
(223) The retractor (3) at least includes a control switch (301) capable of adjusting a tension of the pull line (2), a pull line fixing mechanism (302), and a casing (304). The control switch (301) of the retractor (3) adopts a thread-bolt structure, and when the bolt-type control switch (301) is rotated, the pull line fixing mechanism (302) moves horizontally along the axial direction of the bolt. When the rotation is clockwise, the pull line fixing mechanism (302) moves leftward, that is, moves toward the top, so that the pull line (2) is tightened; when the rotation is anticlockwise, the pull line fixing mechanism (302) moves rightward, that is, moves toward the bottom, so that the pull line (2) is loosened, as shown in
(224) The retractor (3) of this embodiment includes the control switch (301), the pull line fixing device (302), and the retractor casing (304). The control switch (301) and the pull line fixing device (302) are mounted in the retractor casing (304) to form a closed container. Positioning concave grooves (302B) on the pull line fixing device and positioning convex steps (304E) on the retractor casing form a concave-convex engagement, and the pull line fixing device (302) is capable of moving along the positioning convex steps (304E), but is incapable of rotating.
(225) The control switch (301) is a bolt structure, and the pull line fixing device (302) is a nut structure, so that the control switch (301) and the pull line fixing device (302) form an adjustable thread-bolt structure. When the control switch (301) is rotated using a screwdriver, the bolt of the control switch (301) is rotated, and the pull line fixing device (302) is restricted by the positioning convex steps (304E) and cannot rotate, but can only move horizontally along the bolt. When the pull line (2) is fixed to the pull line fixing device (302), the objective of tightening or loosening the pull line (2) can be achieved.
(226) The pull line fixing device (302) includes thread holes (302A), the positioning concave grooves (302B), and an internal thread (302J). The thread holes (302A) are used for tying the pull line (2) so as to fix the pull line (2). The positioning concave grooves (302B) are used for forming a concave-convex engagement with the positioning convex steps (304E) on the retractor casing, so as to prevent rotary movement of the pull line fixing device (302). The internal thread (302J) is used for being engaged with the bolt of the control switch (301), so that the pull line fixing device (302) can move horizontally when the bolt of the control switch (301) is rotated.
(227) The retractor casing (304) includes thread holes (304A), a seal ring (304B), screw holes (304C), the positioning convex steps (304E) and a main body (304L). The thread holes (304A) are used for the pull line (2) to pass through. The seal ring (304B) is made of medical grade silica gel, and not only allows the pull line (2) to pass through, but also has a sealing function to block human tissues from growing and penetrating into the main body (304L). The screw holes (304C) are used for fixing the retractor (3) to the mandible (5). The positioning convex steps (304E) and the positioning concave grooves (302B) on the pull line fixing device form a concave-convex engagement, so as to prevent rotary movement of the pull line fixing device (302). The main body (304L) is used for mounting and fixing the control switch (301) and serves as a support for bearing the pull line fixing device (302). At the same time, a closed space may be formed to block human tissues from growing and penetrating into the main body (304L), thereby ensuring the adjustment function of the control switch (301).
(228) The structure of the retractor (3) shown in this embodiment is reliable, can conveniently fix the pull line (2), is easily mounted onto the mandible, can be manufactured into small components, and is conveniently implanted into the human body.
Embodiment 12
A Retractor of a Bolt Adjustment Type Having a Sealing Top Cover of the Present Invention
(229) Referring to
Embodiment 13
A Retractor of a Bolt Adjustment Type Having an Anti-Cutting Buffer Device of the Present Invention
(230) Referring to
(231) The anti-cutting buffer device (303) in this embodiment is four coil springs, where top ends of the four coil springs are connected to a binding plate (302C), and bottom ends of the four coil springs are mounted on spring positioning posts (302D) of the pull line fixing device (302).
(232) The pull line (2) is bound to the binding plate (302C), and when the pull line (2) receives an excessive tension, the coil springs of the anti-cutting buffer device (303) deform, and the springs are compressed to eliminate the excessive tension, so as to prevent the pull plate (1) from cutting the soft tissues of the tongue.
(233) The tension for causing deformation of the coil springs of the anti-cutting buffer device (303) is generally set to 100 g to 3000 g, and preferably 500 g to 1000 g, which may be set according to the maximum tensions of the tongues of different patients and the contact area between the pull plate (1) and the tongue base portion. The setting principle is that: under the maximum tension, the maximum pressure generated by the pull plate (1) is lower than the pressure when the soft tissues are cut, and is generally required to be smaller than 7000 g/cm.sup.2.
(234) The elastic force of the spring structure of the anti-cutting buffer device (303) is generally smaller than 1000 g, or the pressure generated on the pull plate (1) by the elastic force of the spring structure of the anti-cutting buffer device (303) is smaller than 7000 g/cm.sup.2, and is preferably 500 g/cm.sup.2 to 1500 g/cm.sup.2. At this time, not only effective pulling to the tongue base (41) and/or the tongue dorsum (42) is maintained, but also injuries caused by cutting the tongue muscles are avoided.
Embodiment 14
A Retractor of a Nut Adjustment Type of the Present Invention
(235) Referring to
(236) The retractor (3) at least includes a control switch (301) capable of adjusting a tension of the pull line (2), a pull line fixing mechanism (302), and a casing (304). The control switch (301) of the retractor (3) adopts a nut adjustment manner, and when the nut-type control switch (301) is rotated, the pull line fixing mechanism (302) moves horizontally along the axial direction of the num. When the rotation is clockwise, the pull line fixing mechanism (302) moves leftward, that is, moves toward the top, so that the pull line (2) is tightened; when the rotation is anticlockwise, the pull line fixing mechanism (302) moves rightward, that is, moves toward the bottom, so that the pull line (2) is loosened, as shown in
(237) The retractor (3) of this embodiment includes the control switch (301), the pull line fixing device (302), and the retractor casing (304). The control switch (301) and the pull line fixing device (302) are mounted in the retractor casing (304) to form a closed container. Positioning convex steps (302E) on the pull line fixing device and positioning concave grooves (304F) on the retractor casing form a concave-convex engagement, and the pull line fixing device (302) is capable of moving along the positioning concave grooves (304F), but is incapable of rotating.
(238) The control switch (301) is a nut structure, and the pull line fixing device (302) is connected to the control switch (301) through a concave-convex engagement structure, that is, positioning convex steps (302F) on the pull line fixing device (302) and a positioning concave groove (301B) on the control switch (301) form a concave-convex engagement structure. When the nut-type control switch (301) is rotated using a screwdriver, the control switch (301) rotates, and at the same time moves linearly along the horizontal direction; and the pull line fixing device (302) is restricted by the positioning concave grooves (304F) on the casing (304) and cannot rotate, but can only move correspondingly along the horizontal direction under the pulling of the control switch (301). When the pull line (2) is fixed to the pull line fixing device (302), the objective of tightening or loosening the pull line (2) can be achieved.
(239) The pull line fixing device (302) includes thread holes (302A), the positioning convex steps (302E), and the positioning convex steps (302F). The thread holes (302A) are used for the pull line (2) to pass through so as to tie and fix the pull line (2). The positioning convex steps (302E) are used for forming a concave-convex engagement with the positioning concave grooves (304F) on the retractor casing, so as to prevent rotary movement of the pull line fixing device (302). The positioning convex steps (302F) are is used for being engaged with the positioning concave groove (301B) of the control switch (301), so that the pull line fixing device (302) can move horizontally when the nut-type control switch (301) is rotated.
(240) The retractor casing (304) includes thread holes (304A), a seal ring (304B), screw holes (304C), the positioning concave grooves (304F), a top cover seal ring (304B1), a top cover (304G), a bottom cover (304H) and a main body (304L). The thread holes (304A) are used for the pull line (2) to pass through. The seal ring (304B) is made of medical grade silica gel, and not only allows the pull line (2) to pass through, but also has a sealing function to block human tissues from growing and penetrating into the main body (304L). The screw holes (304C) are used for fixing the retractor (3) to the mandible (5). The positioning concave grooves (304F) and the positioning convex steps (302E) of the pull line fixing device form a concave-convex engagement, so as to prevent rotary movement of the pull line fixing device (302). The top cover (304G) includes a rotary positioning slot (304G1). The rotary positioning slot (304G1) may be elliptical or polygonal, into which a corresponding tool may be inserted in order to rotate the top cover (304G). The top cover seal ring (304B1) is used for sealing purpose to block human tissues from growing and penetrating into the main body (304L). The bottom cover (304H) includes an external thread for being engaged with the internal thread of the main body (304L) to tightly press the seal ring (304B), so as to achieve sealing. The bottom cover (304H) includes elliptical through holes, which may serve as the thread holes (304A) for the pull line (2) to pass through, and into which a corresponding tool may be inserted in order to rotate the bottom cover (304H), thereby facilitating assembly. The main body (304L) is used for mounting and fixing the control switch (301) and serves as a support for bearing the pull line fixing device (302). At the same time, a closed space may be formed to block human tissues from growing and penetrating into the main body (304L), thereby ensuring the adjustment function of the control switch (301).
(241) The retractor (3) of a nut adjustment type shown in this embodiment has a reliable structure, has good sealing performance, can conveniently fix the pull line (2), is easily mounted onto the mandible, can be manufactured into small components, and is conveniently implanted into the human body.
Embodiment 15
A Retractor of a Nut Adjustment Type Having an Anti-Cutting Buffer Device of the Present Invention
(242)
(243) The anti-cutting buffer device (303) in this embodiment is four coil springs, where top ends of the four coil springs are connected to a binding plate (302C), and bottom ends of the four coil springs are mounted on spring positioning posts (302D) of the pull line fixing device (302).
(244) The pull line (2) is bound to the binding plate (302C), and when the pull line (2) receives an excessive tension, the coil springs of the anti-cutting buffer device (303) deform, and the springs are compressed to eliminate the excessive tension, so as to prevent the pull plate (1) from cutting the soft tissues of the tongue.
(245) The tension for causing deformation of the coil springs of the anti-cutting buffer device (303) is generally set to 100 g to 3000 g, and preferably 500 g to 1000 g, which may be set according to the maximum tensions of the tongues of different patients and the contact area between the pull plate (1) and the tongue base portion. The setting principle is that: under the maximum tension, the maximum pressure generated by the pull plate (1) is lower than the pressure when the soft tissues are cut, and is generally required to be smaller than 7000 g/cm.sup.2.
(246) The elastic force of the spring structure of the anti-cutting buffer device (303) is generally smaller than 1000 g, or the pressure generated on the pull plate (1) by the elastic force of the spring structure of the anti-cutting buffer device (303) is smaller than 7000 g/cm.sup.2, and is preferably 500 g/cm.sup.2 to 1500 g/cm.sup.2. At this time, not only effective pulling to the tongue base (41) and/or the tongue dorsum (42) is maintained, but also injuries caused by cutting the tongue muscles are avoided.
Embodiment 16
A Push-Pull Type Retractor of the Present Invention
(247) Referring to
(248) The retractor (3) includes a control switch (301) capable of adjusting a tension of the pull line (2), a pull line fixing module (302), and a casing (304). The control switch (301) of the retractor (3) adopts a push-pull adjustment manner, and when the adjustment handle (301F) of the control switch (301) is pressed, the positioning convex steps (301A) on the control switch detach from the positioning concave grooves (304F) on the inner side of the casing, and the control switch (301) can move leftward or rightward, so as to drive the pull line fixing module (302) to move leftward or rightward to achieve the objective of adjusting the pulling distance. When the adjustment handle (301F) is released, under the action of the elastic force, the positioning convex steps (301A) on the control switch (301) are engaged into the positioning concave grooves (304F) on the inner side of the casing, so as to form the concave-convex engagement structure, thereby achieving positioning.
(249) The moving distance of the pull line fixing module (302) is generally 5 mm to 20 mm. The outer diameter of the retractor (3) is generally 1 mm to 10 mm, and preferably 2 mm to 6 mm.
(250) The control switch (301) and the pull line fixing device (302) of the retractor of this embodiment are mounted in the retractor casing (304), so as to form a closed container.
(251) The control switch (301) includes the positioning convex steps (301A) and the adjustment handle (301F) of the control switch. The adjustment handle (301F) is bent centripetally, so that the positioning convex steps (301A) detach from the positioning concave grooves (304F) on the inner side of the casing. Through pushing or pulling, the position of the control switch (301) can be adjusted. In addition, the control switch (301) is mounted in the pull line fixing device (302), and the positioning convex steps (301A) are engaged in positioning concave grooves (302G) of the pull line fixing device, so that the control switch (301) can drive the pull line fixing device (302) to move. The pull line fixing device (302) includes a binding plate (302C) for binding and fixing the pull line (2).
(252) The retractor casing (304) includes thread holes (304A), a seal ring (304B), screw holes (304C), the positioning concave grooves (304F), a top cover seal ring (304B1), a top cover (304G), a bottom cover (304H) and a main body (304L). The thread holes (304A) are used for the pull line (2) to pass through. The seal ring (304B) is made of medical grade silica gel, and not only allows the pull line (2) to pass through, but also has a sealing function to block human tissues from growing and penetrating into the main body (304L). The screw holes (304C) are used for fixing the retractor (3) to the mandible (5). The positioning concave grooves (304F) on the inner side of the casing and the positioning convex steps (301A) on the control switch (301) form the concave-convex engagement structure, so as to achieve positioning during adjustment. The top cover (304G) includes a rotary positioning slot (304G1). The rotary positioning slot (304G1) may be elliptical or polygonal, into which a corresponding tool may be inserted in order to rotate the top cover (304G). The top cover seal ring (304B1) is used for sealing purpose to block human tissues from growing and penetrating into the main body (304L). The bottom cover (304H) includes an external thread for being engaged with the internal thread of the main body (304L) to tightly press the seal ring (304B), so as to achieve sealing. The bottom cover (304H) includes elliptical through holes, which may serve as the thread holes (304A) for the pull line (2) to pass through, and into which a corresponding tool may be inserted in order to rotate the bottom cover (304H), thereby facilitating assembly. The main body (304L) is used for mounting and fixing the control switch (301) and serves as a support for bearing the pull line fixing device (302). The positioning concave grooves (304F) on the inner side of the casing and the positioning convex steps (301A) on the control switch (301) form the concave-convex engagement structure, so as to achieve positioning during adjustment. At the same time, the casing (304) may form a closed space to block human tissues from growing and penetrating into the main body (304L), thereby ensuring the adjustment function of the control switch (301).
Embodiment 17
A Push-Pull Type Retractor Having an Anti-Cutting Buffer Device of the Present Invention
(253) Referring to
(254) The anti-cutting buffer device (303) in this embodiment is a corrugated spring plate, and the pull line (2) is bound and fixed to the corrugated spring plate. When the pull line (2) receives an excessive tension, the corrugated spring plate of the anti-cutting buffer device (303) deforms, and the spring plate is stretched straight to eliminate the excessive tension, so as to prevent the pull plate (1) from cutting the soft tissues of the tongue.
(255) The tension for causing deformation of the corrugated spring plate of the anti-cutting buffer device (303) is generally set to 100 g to 3000 g, and preferably 500 g to 1000 g, which may be set according to the maximum tensions of the tongues of different patients and the contact area between the pull plate (1) and the tongue base portion. The setting principle is that: under the maximum tension, the maximum pressure generated by the pull plate (1) is lower than the pressure when the soft tissues are cut, and is generally required to be smaller than 7000 g/cm.sup.2.
(256) The elastic force of the spring structure of the anti-cutting buffer device (303) is generally smaller than 1000 g, or the pressure generated on the pull plate (1) by the elastic force of the spring structure of the anti-cutting buffer device (303) is smaller than 7000 g/cm.sup.2, and is preferably 500 g/cm.sup.2 to 1500 g/cm.sup.2. At this time, not only effective pulling to the tongue base (41) and/or the tongue dorsum (42) is maintained, but also injuries caused by cutting the tongue muscles are avoided.
Embodiment 18
A Clutch-Type Retractor of the Present Invention
(257) Referring to
(258) The retractor (3) of this embodiment includes a control switch (301), a pull line fixing device (302), and a retractor casing (304). The casing (304) is a closed container, in which the control switch (301) and the pull line fixing device (302) are mounted.
(259) The control switch (301) is a pair of concave and convex gears engaged with each other, and is formed by positioning convex steps (301A) on a convex gear (301A1) fixed to a top cover (304G) of the casing and positioning concave grooves (301B) on a concave gear (301B1) fixed to the top of the pull line fixing device (302). When the concave gear (301B1) is pressed, the positioning concave grooves (301B) and the positioning convex steps (301A) detach from one another, that is, a detached state is entered. The concave gear (301B1) is rotated to drive the shaft of the pull line fixing device (302) to rotate, so as to achieve the objective of tightening the pull line (2) or loosening the pull line (2). When the concave gear (301B1) is released, under the action of a spring (302H), the positioning concave grooves (301B) and the positioning convex steps (301A) are combined together, so that the shaft of the pull line fixing device (302) cannot rotate, thereby achieving positioning.
(260) The pull line fixing device (302) is a rotary shaft structure. The concave gear (301B1) is disposed at the top of the pull line fixing device (302) to serve as a part of the control switch (301). A bobbin (302L) and a thread hole (302A) are provided in the middle of the pull line fixing device (302), where the bobbin (302L) is used for winding the pull line (2), and the thread hole (302A) is used for fixing the pull line (2). A spring positioning post (302D) is disposed at the bottom of the pull line fixing device (302), and is used for positioning the spring (302H).
(261) The casing (304) is a cylindrical casing, having a side hole at the right side thereof. The casing (304) includes the top cover (304G) at the upper part thereof, where a silica gel plug (304D) may be mounted in a through hole (304G2) of the top cover (304G). After the silica gel plug (304D) is removed, a screwdriver may be used to press and rotate the concave gear (301B1); and after the silica gel plug (304D) is mounted, human tissues are blocked from growing and penetrating into the casing (304). The top cover (304G) includes the convex gear (301A1) at the lower part thereof, where the convex gear (301A1) and the concave gear (301B1) form a pair of concave and convex gears engaged with each other, and the positioning convex steps (301A) on the convex gear (301A1) and the positioning concave grooves (301B) on the concave gear (301B1) form the control switch (301). The top cover (304G) includes a pair of fixing lugs on a side surface thereof, and screw holes (304C) are formed on the fixing lugs. The main body (304L) of the casing (304) includes a pair of fixing lugs at the upper part thereof, and screw holes (304C) are formed on the fixing lugs, where the screw holes (304C) are used for connecting the top cover (304G) and the main body (304L), which may be fixed to the mandible by using screws. The main body (304L) includes a positioning slot for mounting the spring (302H) at the lower part thereof, where the spring (302H) is mounted in the positioning slot, with one end connected to the spring positioning post (302D) at the bottom part of the pull line fixing device (302). The main body (304L) has a side hole (304N) on a side surface thereof. The bottom cover (304H) is thread-connected to the main body (304L). The bottom cover (304H) has an elliptical thread hole (304A), and a seal ring (304B) can be fixed by tightening the bottom cover (304H). The pull line (2) is sequentially passed through the thread hole (304A) and the seal ring (304B), and after entering the side hole (304N) of the main body (304L), is wound onto the bobbin (302L), and the ends of the pull line (2) are fixed to the thread hole (304A). When the bobbin (302L) is rotated anticlockwise, the pull line (2) is tightened, and when the bobbin (302L) is rotated clockwise, the pull line (2) is loosened.
(262) This embodiment shows a retractor (3) that is adjusted by winding, and has advantages such as reliable structure and convenient adjustment.
Embodiment 19
A Clutch-Type Retractor Having an Anti-Cutting Buffer Device of the Present Invention
(263) Referring to
(264) Firstly, an anti-cutting buffer device (303) is included. The anti-cutting buffer device (303) adopts a densely wrapped coil spring structure, is disposed in the casing (304), and mounted at a part of the pull line (2) that is located in the casing (304). Two ends of the densely wrapped coil spring of the anti-cutting buffer device (303) are respectively connected to the pull line (2), where the pull line (2) at one end is fixed to the thread hole (302A), and wound onto the bobbin (302L), and the other end is connected to the pull line (2), which is passed through the seal ring (304B) and the thread hole (304A), and then fixed to the pull plate (1).
(265) Secondly, the side surface (304M) of the casing (304) has a flat plate shape, and the side hole (304N) is long, to which the bottom cover (304H) of the casing, the seal ring (304B), and a fixing nut (3041) are mounted sequentially.
(266) Thirdly, the screw holes (304C) for fixing the casing (304) to the mandible are provided on the side surface (304M) of the casing, which facilitates mounting onto the mandible.
Embodiment 20
A Ratchet-Type Retractor of the Present Invention
(267) Referring to
(268) The retractor (3) of this embodiment includes a control switch (301), a pull line fixing device (302), and a retractor casing (304). The casing (304) is a closed container, in which the control switch (301) and the pull line fixing device (302) are mounted. The control switch (301) is divided into a tightening switch (301C) and a loosening switch (301D).
(269) The tightening switch (301C) adopts a ratchet structure. The tightening switch (301C) includes ratchet (301B2) at the bottom thereof, and the ratchet (301B2) includes positioning concave grooves (301B).
(270) The loosening switch (301D) includes a positioning convex step (301A), and the positioning convex step (301A) and the positioning concave grooves (301B) on the ratchet form a concave-convex engagement. The positioning convex step (301A) includes a spring positioning post (301G) at the bottom thereof, and the spring positioning post (301G) is mounted with a spring (301E).
(271) When the tightening switch (301C) is rotated clockwise, the pull line (2) is wound onto the bobbin (302L), and the positioning convex step (301A) on the loosening switch (301D) stops the bobbin (302L) from rotating back, so that the pull line (2) is tightened. When the loosening switch (301D) is pressed, the positioning convex step (301A) detaches from the engaged position, and the bobbin (302L) can rotate back, so as to loosen the pull line (2).
(272) The pull line fixing device (302) is a shaft winding structure, where the bobbin (302L) includes a thread hole (302A). The thread hole (302A) is used for fixing the pull line (2), and the bobbin (302L) is used for winding the pull line (2). The bobbin (302L) is connected to the tightening switch (301C). When the tightening switch (301C) is rotated, the bobbin (302L) rotates along therewith.
(273) The casing (304) is a cylindrical casing, having a side hole (304N) at the right side thereof, where the side hole (304N) has an internal thread, which can be engaged with an external thread of a bottom cover (304H). A seal ring (304B) and the bottom cover (304H) may be sequentially mounted to the side hole (304N). The pull line (2) is sequentially passed through a thread hole (304A) and the seal ring (304B), and after entering the side hole (304N) of the main body (304L), is wound onto the bobbin (302L), and the ends of the pull line (2) are fixed to the thread hole (304A). When the bobbin (302L) is rotated clockwise, the pull line (2) is tightened, and when the bobbin (302L) is rotated anticlockwise, the pull line (2) is loosened.
(274) The casing (304) includes a top cover (304G) at the upper part thereof, where a silica gel plug (304D) may be mounted in a through hole (304G2) of the top cover (304G). After the silica gel plug (304D) is removed, the tightening switch (301C) may be rotated to tighten the pull line (2); or the loosening switch (301D) may be pressed so that the tightening switch (301C) is in a loosened state, thereby loosening the pull line (2).
(275) The top cover (304G) and the main body (304L) of the casing (304) may be fixed to each other by using screws or by welding. The casing (304) may be fixed to the mandible by using screws.
(276) It should be particularly noted that, the silica gel plug (304D) may be manufactured into a color similar to that of the skin at the mandible of the human body, so that since titanium alloys have high biocompatibility, the top cover (304G) made of medical grade titanium metal of the casing can be exposed out of the skin at the mandible of the human body, and the silica gel plug (304D) that is manufactured into a color similar to that of the skin at the mandible of the human body has a beautifying function, and also facilitates adjusting the tension of the pull line (2) after surgery. For example, when adjustment is needed, the silica gel plug (304D) removed first, and after adjustment, the silica gel plug (304D) is mounted. The adjustment of the tension of the pull line (2) after surgery is based on the following principle:
(277) In a non-sleep state, the loosening switch (301D) is pressed so as to adjust the control switch (301) to an “off” state, and at this time, the pull lines (2) apply a small pulling force to the tongue base portion or are completely in a loosened state, and the tongue is capable of moving freely during speaking, swallowing and other activities.
(278) Before sleep, the tightening switch (301C) is tightened so as to adjust the control switch (301) to an “on” state, and at this time, a large pulling force is applied to the tongue base portion, so that the tongue base portion is in an effective retracted state, and the tongue base portion is pulled forward, so as to maintain the palatopharyngeal portion open, thereby preventing OSAHS.
Embodiment 21
A Single-Switch Push-Pull Type Retractor of the Present Invention
(279) Referring to
(280) This embodiment shows a retractor (3), in which after the control switch (301) is pressed, the position of the pull line fixing device (302) can be conveniently adjusted by pushing or pulling, so as to tighten or loosen the pull line (2); and once the control switch (301) is released, the control switch (301) can be automatically locked and positioned.
(281) The retractor (3) of this embodiment includes a control switch (301), a pull line fixing device (302), and a retractor casing (304). The casing (304) is a closed container, in which the control switch (301) and the pull line fixing device (302) are mounted.
(282) The control switch (301) is a concave-convex engagement structure formed by a beam-type positioning convex step (301A) and a tooth rack-type positioning concave groove (301B), specifically:
(283) The control switch (301) includes a beam-type positioning convex step (301A), and the beam-type positioning convex step (301A) is provided on the pull line fixing device (302) and connected to an adjustment handle (301F). The pull line fixing device (302) includes a thread hole (302A) and a bolt (302I) for fixing the pull line (2). The pull line fixing device (302), the pull line fixing bolt (302I), the beam-type positioning convex step (301A), the adjustment handle (301F), a spring (301E) and a positioning slide-block cover (302M1) are sequentially mounted in a positioning slide block (302M), and can slide in a positioning slot opening (304P) and a positioning concave groove (304F) of the casing as a whole.
(284) The tooth rack-type positioning concave groove (301B) of the control switch (301) is provided on the casing (304), and two tooth racks (301B3) are symmetrically distributed in parallel at the upper part of the main body (304L). The positioning slide block (302M) of the pull line fixing device can slide in the positioning slot opening (304P) between the two tooth racks (301B3).
(285) The pull line fixing device (302) includes a thread hole (302A) and a fixing bolt (302I) for fixing the pull line. The pull line (2) is passed through the thread hole (302A), and the fixing bolt (302I) is tightened, so as to fix the pull line (2). The pull line fixing device (302) further includes a positioning slide block (302M), where the positioning slide block (302M) is a rectangular casing. The positioning slide block (302M) includes a positioning slide-block cover (302M1) and a positioning slide-block slot opening (302M2). The adjustment handle (301F), the spring (301E), the thread hole (302A) and the fixing bolt (302I) are sequentially mounted in the positioning slide block (302M). The beam-type positioning convex step (301A) of the control switch (301) is passed through the positioning slide-block slot opening (302M2), and is capable moving vertically in a direction perpendicular to the positioning slide-block slot opening (302M2).
(286) The retractor casing (304) includes a main body (304L), and the main body (304L) includes a vertical fixing plate (304L1) and a horizontal fixing plate (304L2). The vertical fixing plate (304L1) and the horizontal fixing plate (304L2) each includes screw holes (304C), and the screw holes (304C) are used for fixing the retractor casing (304) to the mandible (5) by using screws (10). The main body (304L) further includes two symmetrical tooth racks (301B3), and a positioning slot opening (304P) is formed between the two tooth racks (301B3). The positioning slot opening (304P) is engaged with the positioning slide block (302M) of the pull line fixing device, so that the positioning slide block (302M) is capable of sliding back and forth along the length direction of the positioning slot opening (304P).
(287) The retractor casing (304) includes a top cover (304G), and the top cover (304G) includes a positioning concave groove (304F). The positioning concave groove (304F) cooperates with the positioning slot opening (304P) in the vertical direction so as to achieve spatial positioning. The positioning slide block (302M) is disposed on the positioning concave groove (304F), and is capable of moving back and forth along the length direction of the positioning slot opening (304P) and the length direction of the positioning concave groove (304F).
(288) The retractor casing (304) further includes a top cover seal ring (304B1) and a fixing plate (304B2) for fixing the top cover seal ring. The top cover seal ring (304B1) is made of a medical film material, and therefore is soft and durable. The fixing plate (304B2) is used for fixing the top cover seal ring (304B1), and the fixing plate (304B2) is fixed to the main body (304L) by means of close fit or using a screw. The fixing plate (304B2) includes a thread hole (304A) for the pull line (2) to pass through.
(289) The retractor (3) of the present invention can be fixed to the mandible by using screws.
(290) It is particularly important that when the retractor (3) of the present invention is used to retract the tongue dorsum portion and/or the tongue base portion, the patient can adjust the pulling degree of the pull line (2) to the tongue dorsum portion and/or the tongue base portion after surgery by pressing the control switch (301) from a position outside the bottom portion of the mandible of the patient and at the same time pushing or pulling the control switch (301). The adjustment is based on the following principle:
(291) In a non-sleep state, the control switch (301) is pressed and pushed toward the tongue base portion so that the pull lines (2) apply a small pulling force to the tongue base portion or are completely in a loosened state, and then the control switch (301) is released so that the control switch (301) is automatically positioned and locked, that is, the control switch (301) is adjusted to an “off” state, and at this time, the tongue base portion is almost unconstrained, and the tongue is capable of moving freely during speaking, swallowing and other activities.
(292) Before sleep, the control switch (301) is pressed and pulled toward the mandible so that the control switch (301) is adjusted to an “on” state, and at this time, the pull lines (2) apply a large pulling force to the tongue base portion, so that the tongue base portion is in an effective retracted state, and the tongue base portion is pulled forward, so as to maintain the palatopharyngeal portion open, thereby preventing OSAHS.
(293) A degree of comfort is set. To avoid daily adjustment, the control switch (301) may be pressed and pulled toward the mandible, and then released at a proper position, so that the pull line (2) applies a proper pulling force to the tongue base portion, so as to move the tongue base portion forward while ensuring comfort during movement of the tongue, and maintain the palatopharyngeal portion open, thereby preventing OSAHS.
Embodiment 22
A Double-Button Ratchet-Type Retractor of the Present Invention
(294) Referring to
(295) This embodiment shows a double-button ratchet-type retractor (3), which has the following characteristics:
(296) The control switch (301) is divided into a tightening switch (301C) and a loosening switch (301D), and adopts a ratchet (301B2) as an adjustment structure. Each time when the tightening switch (301C) is pressed, a positioning convex step (301A) on the tightening switch (301C) pushes the ratchet (301B2) to rotate by one step, so as to drive the pull line fixing device (302) to move to tighten the pull lines (2). A positioning convex step (301A) on the loosening switch (301D) is used for stopping reverse rotation of the ratchet (301B2), so as to prevent loosening of the tightened pull lines (2). When the loosening switch (301D) is pressed, the ratchet (301B2) is released, so that the ratchet (301B2) is in a free state, which drives the pull line fixing device (302) to enter a loosened state, thereby loosening the pull line (2).
(297) Specifically, this embodiment the retractor (3) includes a control switch (301), a pull line fixing device (302), and a retractor casing (304).
(298) The control switch (301) is divided into a tightening switch (301C) and a loosening switch (301D). Both the tightening switch (301C) and the loosening switch (301D) adopt a pushrod structure, and a spring (301E) is used for restoring the pushrod. The tightening switch (301C) and the loosening switch (301D) each include a positioning convex step (301A), where the positioning convex step (301A) adopts a reed structure. The positioning convex step (301A) on the tightening switch (301C) includes a wedge-shaped slide block (301A1) and a spring (301E1), where the spring (301E1) is mounted on the wedge-shaped slide block (301A1). The positioning convex step (301A) on the loosening switch (301D) includes a wedge-shaped slide block (301A2) and a spring (301E2), where the spring (301E2) is mounted on the wedge-shaped slide block (301A2).
(299) Tighten the pull line: Each time when the tightening switch (301C) is pressed, the positioning convex step (301A) on the tightening switch (301C), that is, the wedge-shaped slide block (301A1), pushes the ratchet (301B2) to rotate by one step, so as to drive the pull line fixing device (302) to move to tighten the pull lines (2). The positioning convex step (301A) on the loosening switch (301D), that is, the wedge-shaped slide block (301A2), is used for stopping reverse rotation of the ratchet (301B2), so as to prevent loosening of the tightened pull lines (2).
(300) Loosen the pull line: When the loosening switch (301D) is pressed, the positioning convex step (301A) on the loosening switch (301D) detaches from the ratchet (301B2), that is, the wedge-shaped slide block (301A2) detaches from the ratchet (301B2), and the ratchet (301B2) is released from the wedge-shaped slide block (301A2), so that the ratchet (301B2) is in a free state, which drives the pull line fixing device (302) to enter a loosened state, thereby loosening the pull line (2).
(301) The pull line fixing device (302) includes a thread hole (302A), a pull line fixing bolt (302I), and a bobbin (302L). The pull line (2) is passed through the thread hole (302A) and fixed by the pull line fixing bolt (302I), and may be wound onto the bobbin (302L). The pull line fixing device (302) is connected to the ratchet (301B2) of the control switch (301), and the ratchet (301B2) of the control switch (301) is rotated to drive the bobbin (302L), thereby winding or loosening the pull line (2).
(302) The retractor casing (304) is used for fixing and mounting the control switch (301) and the pull line fixing device (302), and includes a main body (304L), a top cover (304G), screws (304J), a thread hole (304A), a silica gel film (304K), a seal ring (304B), a casing side plate (304L1), and screw holes (304C). The control switch (301) and the pull line fixing device (302) are mounted in the retractor casing (304). The top cover (304G) is fixed to the main body (304L) by using the screws (304J). The pull line (2) is passed through the thread hole (304A) and the seal ring (304B), and then fixed into the thread hole (302A) of the pull line fixing device (302) by the pull line fixing bolt (302I). Buttons of the tightening switch (301C) and the loosening switch (301D) are wrapped by the silica gel film (304K), and the silica gel film (304K) and the seal ring (304B) are fixed to the main body (304L) by the casing side plate (304L1). The screw holes (304C) are used for fixing the retractor casing (304) to the mandible (5).
(303) Fast loosening of the pull line: To achieve fast loosening of the ratchet (301B2), a restoring spring (305) may further be mounted. The restoring spring (305) is a coil spring, which may provide a force for driving reverse rotation of the ratchet (301B2), so that the ratchet (301B2) reversely rotates rapidly, and drives the pull line fixing device (302) to enter a loosened state, thereby achieving fast loosening of the pull line (2). The restoring spring (305) has one end fixed to the bobbin (302L) and the other end fixed to the main body (304L). Each time when the tightening switch (301C) is pressed, the ratchet (301B2) is pushed to rotate by one step, so as to gradually compress the restoring spring (305), and the restoring spring (305) gradually stores elastic deformation energy. When the loosening switch (301D) is pressed, the positioning convex step (301A) on the loosening switch (301D) detaches from the ratchet (301B2) to release the ratchet (301B2), so that the force restricting the compressed restoring spring (305) is removed, and the elastic energy stored by the restoring spring (305) is released, so as to drive reverse rotation of the pull line fixing device (302), thereby achieving fast loosening of the pull line (2). Refer to
(304) Fast mounting of the pull line: To enable the doctor to conveniently mount this product, the retractor (3) may further be provided with a protective sheath (306). The protective sheath (306) is a thin wall tube made of a medical flexible material, and is mounted in the retractor casing (304), and sequentially passed through the thread hole (304A) and the seal ring (304B) on the casing, the thread hole (302A) on the pull line fixing device, the top cover seal ring (304B1) of the casing, and a through hole (304A1) on a nut for fixing the top cover seal ring of the casing. The pull line (2) may be passed along the protective sheath (306), which not only provides a routing function, but also protects the pull line (2). Refer to
(305) During mounting, first, the retractor (3) is fixed to the lower part of the mandible (5), and tightened by using screws. Then, one end of each of four pull lines (2) is fixed to a corresponding one of four corners of the pull plate (1). Next, a surgical knife is used to incise the mucous membrane of the tongue base portion, and the pull plate (1) is implanted into the muscular layer under the mucous membrane layer of the tongue base portion and/or the tongue dorsum portion of the human body. A special surgical retractor is penetrated into the tongue body from a position close to the mandible (5), and the four pull lines (2) are respectively drawn to the vicinity of the mandible (5) by using the surgical retractor. The pull lines (2) are guided into the protective sheath (306) from the bottom end of the protective sheath (306), and then drawn out from the top end of the protective sheath (306). The pull lines (2) are properly tightened so as to maintain effective pulling to the tongue base portion. The pull lines (2) drawn out from the top end of the protective sheath (306) is tied, and then the protective sheath (306) and the pull lines (2) are properly pulled downward, so that the protective sheath (306) and the pull lines (2) enter the casing (304) of the retractor. Finally, the pull line fixing bolt (302I) is tightened to fix the pull lines (2) to the thread hole (302A) of the pull line fixing device, thus completing the whole mounting process. The surgical incisions are sutured, thus completing the surgical operation. Refer to
Embodiment 23
A Double-Button Ratchet Thread-Type Retractor of the Present Invention
(306) Referring to
Embodiment 24
A Tongue Pulling Device of the Present Invention that is Adjusted by the Patient from a Position Between the Lower Lip and the Lower Teeth after Surgery
(307) Referring to
(308) The tongue pulling device of the present invention is mounted on the front surface of the mandible and close to the bottom portion of the mandible, so that the control switch (301) of the adjusted retractor faces upward. In this way, after surgery, the lower lip is pulled apart, and a screwdriver (9) is inserted into a cross slot of the control switch (301) to rotate the bolt that serves as the control switch (301), so as to tighten or loosen the pull line (2).
(309) Adjustment can be carried out from a position between the lower lip and the lower teeth, a small surgical wound is created, the appearance of the patient is not affected, and adjustment by the patient is facilitated.
Embodiment 25
A Tongue Pulling Device of the Present Invention that is Adjusted by the Patient from the Bottom Portion of the Mandible after Surgery
(310) Referring to
(311) The tongue pulling device of the present invention is mounted on the front surface of the mandible and close to the bottom portion of the mandible. The silica gel plug (304D) of the casing of the tongue pulling device of the present invention is outside the skin at the bottom portion of the mandible, and has the same color as that of the skin at the bottom portion of the mandible. The silica gel plug (304D) is removed, and the screwdriver (9) is used to press the control switch (301) upward and at the same time rotate the control switch (301), so as to tighten or loosen the pull line (2) to adjust the tension of the pull line (2), thereby controlling the pulling degree of the tongue base portion and/or the tongue dorsum portion.
Embodiment 26
A Double-Retractor Tongue Pulling Device of the Present Invention
(312) Referring to
(313) In this embodiment, the difference lies in that: two retractors (3) are mounted on the front portion of the mandible and close to the bottom portion of the mandible, and the distance between the two retractors (3) is about 10 mm to 25 mm. At this time, retractors (3) having a small diameter and having an anti-cutting buffer device (303) are generally used, so as to achieve the objective of minimal invasive treatment.
Embodiment 27
A Tongue Pulling Device Having a Combined-Type Pull Plate of the Present Invention
(314) Refer to
(315) The gap (109C) is required to provide such a space that can maintain normal survival and tension of the tongue tissues in the gap, particularly, continuity of musculus genioglossus and other fibrous tissues to the fibrous tissues under the mucous membrane of the tongue dorsum or the tongue base, which on one hand reduces the wound, and on the other hand increases the pulling force to the tongue dorsum (42) and/or the tongue base (41). The maximum width (H109) of the gap (109C) is 1 mm to 10 mm, and preferably 2 mm to 5 mm. The length (L109) of the gap (109C) is 5 mm to 20 mm, and preferably 5 mm to 15 mm.
(316) The mechanical connection mechanism (109E) is a mechanical fixing mechanism capable of fixing two metal plates, and is for example a rivet structure, a concave-convex engagement structure, a thread fixing structure or other mechanical fixing mechanisms. In this embodiment, the rivet structure is adopted. Titanium metal rivets (109E1) are used at the junctions (109D) between the left-side pull plate (109A) and the right-side pull plate (109B) to rivet the left-side pull plate (109A) to the right-side pull plate (109B).
(317) The pull line (2) has one end fixed to the pull line fixing structure (102) so as to be connected to the pull plate (1), and the other end fixed to the retractor (3) so as to be connected to the retractor (3). The four pull lines (2) spatially position the pull plate (1). Meanwhile, the left-side pull plate (109A) and the right-side pull plate (109B) are combined through the rivets (109E1), and fibrous tissues of the tongue muscles are sandwiched in the gap (109C) between the left-side pull plate (109A) and the right-side pull plate (109B). Through the gap (109C), the continuity of musculus genioglossus and other fibrous tissues to the fibrous tissues under the mucous membrane of the tongue dorsum or the tongue base is maintained. On one hand, the wound is reduced. On the other hand, since the rivets (109E1) are inserted for fixing, and fibrous tissues of musculus genioglossus are sandwiched between the left-side pull plate (109A) and the right-side pull plate (109B), the capability of spatially positioning the pull plate (1) is further improved, thereby effectively preventing shifting of the pull plate (1); and the pulling force to the tongue dorsum (42) and/or the tongue base (41) is increased.
(318) Surgical Method for Treating OSAHS in this Embodiment:
(319) A surgical method for implanting the tongue pulling device of the present invention mainly includes the following steps:
(320) Firstly, surgical sites such as the tongue and the oral cavity are disinfected under anesthesia according to general requirements of oral cavity, head and neck surgeries.
(321) Secondly, fixing one end of each of two pull lines to a left-side pull plate (109A), and fixing one end of each of another two pull lines to a right-side pull plate (109B); then, using a surgical knife to make incisions of about 3 mm to 6 mm at a position about 10 mm to 15 mm from circumvallate papillae of the tongue and beside two sides of the midline of the tongue, and of about 8 mm transversely cutting the mucous membrane of the tongue, and using a moderately curved hemostatic forceps to separate the mucous membrane toward the tongue base, so as to form an about 40 mm deep surgical cavity on left and right sides of the midline of the tongue respectively; using a special surgical forceps (13) to simultaneously insert the left-side pull plate (109A) and the right-side pull plate (109B) into the surgical cavities below the mucous membrane of the tongue dorsum (42) and/or the tongue base (41) to be retracted; during insertion, a distance between the left-side pull plate (109A) and the right-side pull plate (109B) is maintained at 1 mm to 10 mm; at the same time, the left-side pull plate (109A) and the right-side pull plate (109B) are maintained symmetrical; and thirdly, closing the special surgical forceps (13), and assembling and fixing the left-side pull plate (109A) to the right-side pull plate (109B) through a mechanical connection mechanism (109E); fibrous tissues of the tongue muscles are sandwiched in a gap (109C) between the left-side pull plate (109A) and the right-side pull plate (109B), and through the gap (109C), continuity of musculus genioglossus and other fibrous tissues to the fibrous tissues under the mucous membrane of the tongue dorsum or the tongue base is maintained.
(322) Thirdly, the pull lines (2) are drawn to the vicinity of the mandible (5) by using a guide needle.
(323) Fourthly, an incision is made along the lower lip to expose the mandible (5), the retractor (3) is fixed to the mandible (5), and at the same time, the pulling lengths of the four pull lines (2) are adjusted respectively, and all the four pull lines (2) are fixed to the retractor (3).
(324) Fifthly, the incisions are sutured, thus completing the surgery.
(325) The Tongue Pulling Device Having the Combined-Type Pull Plate of the Present Invention has the Following Advantages:
(326) With the use of the flat pull plate (1), the contact area between the pull plate (1) and the retracted portion of the tongue body is increased, so that the pressure generated during pulling is greatly reduced, which not only improves the pulling effect, but also avoids cutting the tongue tissues when the tongue body is retracted, thereby reducing injuries. Particularly, with the use of the combined-type pull plate (1) formed by the left-side pull plate (109A) and the right-side pull plate (109B), continuity of musculus genioglossus and other fibrous tissues to the fibrous tissues under the mucous membrane of the tongue dorsum or the tongue base is maintained to the maximum extent, thereby further enhancing the capability of spatially positioning the pull plate (1) and improving the effect of retracting the tongue dorsum (42) and/or the tongue base (41).
(327) Secondly, with the use of the spatial pulling mode with four pull lines (2), shifting of the pull plate (1) after implantation is effectively prevented. Particularly, after the combined-type pull plate (1) formed by the left-side pull plate (109A) and the right-side pull plate (109B) is used, rivets (109E1) for fixing the left-side pull plate (109A) and the right-side pull plate (109B) are inserted into musculus genioglossus, which further improves the stability of the pull plate (1) so that the pull plate (1) does not easily displace.
(328) Thirdly, the retractor (3) is conveniently fixed to the mandible (5), and the pull lines (2) are fixed to the retractor (3), so that the pulling degree of the pull lines (2) can be conveniently adjusted to accurately control the pulling distance and the pulling force, thereby achieving an optimal therapeutic effect. Particularly, when the double-button type retractor (3) that can be adjusted after surgery is used, not only the doctor can conveniently adjust and fix the pull lines (2) during surgery, but also woundless adjustment can be achieved after surgery.
Embodiment 28
A Tongue Pulling Device Having a U-Shaped Combined-Type Pull Plate of the Present Invention
(329) Refer to
(330) The left-side pull plate (109A) and the right-side pull plate (109B) of this embodiment have a U-shaped cross section, as shown in
(331) Secondly, in this embodiment, the mechanical connection mechanism (109E) between the left-side pull plate (109A) and the right-side pull plate (109B) adopts a concave-convex engagement structure, where convex steps on the lock screw (109E4) and a concave groove on a lock nut (109E3) form the concave-convex engagement structure, as shown in
(332) In addition, the gap (109C) formed between the left-side pull plate (109A) and the right-side pull plate (109B) in this embodiment is accomplished through corresponding curvatures of assembled edges of the left-side pull plate (109A) and the right-side pull plate (109B), as shown in
Embodiment 29
A Pull Line Formed by Spirally Braided Wires of the Present Invention
(333) This embodiment shows a pull line (2) of the present invention, which, as shown in
Embodiment 30
A Composite Pull Line of a Corrugated Tube Type of the Present Invention
(334) Referring to
(335) The corrugated tube in this embodiment may be made of a medical metal material or a medical polymer material. Metal corrugated tubes include titanium and titanium alloy corrugated tubes, medical grade stainless steel corrugated tubes and the like. The corrugated tubes of medical polymer materials include medical grade polytetrafluoroethylene corrugated tubes, medical grade terylene corrugated tubes, medical grade polythene corrugated tubes, medical grade polyurethane corrugated tubes and the like.
Embodiment 31
A Composite Pull Line of a Coil Spring Tube Type of the Present Invention
(336) Referring to
Embodiment 32
A Pull Line of a Pearl Necklace Type of the Present Invention
(337) Referring to
(338) The present invention provides a method for treating OSAHS, including:
(339) providing an implanted tongue pulling device, where the tongue pulling device is implanted into the mandible (5) and the tongue body (4) of a human body to tighten the tongue dorsum (42) and/or the tongue base (41), is suitable for treating OSAHS, and includes:
(340) a pull plate (1), being a flat implant capable of being implanted under the mucous membrane layer of the tongue body, and including through holes (101) allowing growth and penetration of fibrous tissues and pull line fixing mechanisms (102);
(341) a pull line (2), being a thread made of a material capable of being implanted into the human body for a long term; and
(342) a retractor (3), including a control switch (301) capable of adjusting a tension of the pull line (2), a pull line fixing device (302) capable of fixing the pull line, and a casing (304), the control switch (301) and the pull line fixing device (302) being mounted in the casing (304),
(343) where the pull line (2) has one end connected to the pull plate (1) and the other end fixed to the retractor (3);
(344) The Present Invention has the Following Prominent Advantages:
(345) The patient after surgery can adjust the tightening degree of the implanted tongue pulling device of the present invention to the tongue dorsum (42) and/or the tongue base (41). In a non-sleeping state, the pulling force of the tongue pulling device of the present invention to the tongue dorsum (42) and/or the tongue base (41) is small so as to facilitate the movement of the tongue. Before sleep, by pressing the control switch (301) outside the skin of the mandible, the pulling force of the tongue pulling device of the present invention to the tongue dorsum (42) and/or the tongue base (41) may be increased to adjust the forward pulling distance of the tongue dorsum (42) and/or the tongue base (41), so as to keep the palatopharyngeal portion open, thereby preventing OSAHS.
(346) Through animal experiments and clinical studies of more than five years, the tongue pulling device of the present invention has overcome numerous technical barriers, particularly, problems such as how to avoid cutting the tongue muscles and how to create a conduit for minimally invasive surgery. Current clinical studies indicate that after surgery, the patients feel good, and have normal speech and swallowing functions. Therefore, the present invention surely has good efficacy, and is an effective method for treating OSAHS.
(347) It should be noted that, the structures disclosed and described in the present invention may be replaced by other structure with the same effect, and the embodiments described in the present invention are not intended to limit the present invention. Though the preferred embodiments of the present invention have been introduced and described in the specification, persons skilled in the art should know that these embodiments are merely described by way of example, and persons skilled in the art may make various changes, improvements, and replacements without departing from the present invention. Therefore, the protection scope of the present invention should be defined in accordance with the spirit and scope of the appended claims of the present invention.