WO2010054603A1 - 可调节的软腭支撑体及植入方法 - Google Patents

可调节的软腭支撑体及植入方法 Download PDF

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Publication number
WO2010054603A1
WO2010054603A1 PCT/CN2009/074959 CN2009074959W WO2010054603A1 WO 2010054603 A1 WO2010054603 A1 WO 2010054603A1 CN 2009074959 W CN2009074959 W CN 2009074959W WO 2010054603 A1 WO2010054603 A1 WO 2010054603A1
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WO
WIPO (PCT)
Prior art keywords
soft palate
hard
support
support body
adjustable
Prior art date
Application number
PCT/CN2009/074959
Other languages
English (en)
French (fr)
Inventor
张湘民
周星
Original Assignee
Zhang Xiangmin
Zhou Xing
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN2008102191690A external-priority patent/CN101732108B/zh
Priority claimed from CN 200910192688 external-priority patent/CN102028559B/zh
Application filed by Zhang Xiangmin, Zhou Xing filed Critical Zhang Xiangmin
Priority to AU2009316097A priority Critical patent/AU2009316097B2/en
Priority to JP2011535863A priority patent/JP5481487B2/ja
Priority to EP09825778.5A priority patent/EP2356954B1/en
Priority to CA2747842A priority patent/CA2747842C/en
Priority to US13/129,383 priority patent/US8656921B2/en
Priority to SG2011035086A priority patent/SG171732A1/en
Publication of WO2010054603A1 publication Critical patent/WO2010054603A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/20—Epiglottis; Larynxes; Tracheae combined with larynxes or for use therewith
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/56—Devices for preventing snoring
    • A61F5/566—Intra-oral devices

Definitions

  • the present invention relates to an adjustable soft palate support, in particular for the treatment of obstructive sleep apnea/hypopnea syndrome (OSAHS) and nasal dryness of an adjustable soft palate support and plant Into the method.
  • OSAHS obstructive sleep apnea/hypopnea syndrome
  • OSAHS Obstructive sleep apnea/hypopnea syndrome
  • Non-surgical treatment methods mainly include:
  • CPAP Continuous positive airway pressure
  • [6] 2 oral appliance.
  • the mandible By placing a device in the mouth, the mandible is moved forward or the tongue is pulled forward, the pharyngeal cavity is enlarged, and the sleepy airway obstruction is released.
  • the oral appliance has a certain irritating and foreign body sensation, and others cannot sleep. Long-term use can also cause temporomandibular joint damage.
  • a method and apparatus for mitigating upper airway obstruction is disclosed in the international application PCT/US2005/00139, which is suitable for forming a sealed cavity in a population, in a sleep bite with the device, A sealed cavity is formed in the population, and a negative pressure generator is connected to the device to pull the soft tissue of the patient's tongue and/or upper respiratory tract Lift or pull away from the pharynx to open the respiratory tract and reduce OSAHS.
  • a tongue forwarder for treating OSA is disclosed in Chinese utility model patent ZL200620110299.7
  • the tongue forwarder comprises a half-moon type base, the upper part of the base has a semi-moon shaped upper bracket formed by the front and rear flanges; the lower part of the base has an arc-shaped rear baffle, and the center of the base has a front and rear edge.
  • the tongue forwarder provides an active occlusion mold for the upper and lower anterior dentition of the patient, so that the upper and lower muscles are always in a relatively tense state under the sleep squatting consciousness, so that the upper and lower jaws and the tongue forwarder form a stable fulcrum.
  • the anchor hole provides a comfortable anchoring position for the tip of the tongue, and the tongue is regulated between the anchor hole and the hyoid bone to maintain the smoothness of the oropharynx airway, thereby achieving the purpose of treating OSAHS and snoring.
  • Surgical treatment methods mainly include:
  • Radiofrequency ablation also known as low-temperature plasma radiofrequency ablation
  • the main purpose is to pierce the electrode into the soft tissue that causes airway obstruction, such as soft palate, tonsil and tongue root.
  • the electric heating causes the tissue to coagulate, necrosis, fibrosis and contraction. It has a certain therapeutic effect, is effective for lighter cases, has poor long-term efficacy, and is ineffective for severe patients.
  • [13] 3 soft palate implantation.
  • a woven snagging soft palate implant is disclosed in the international application PCT/US2002/0079662002.3.14, which uses a braid to soften the center of gravity of the soft palate with the airflow and to change the aerodynamics of the soft palate.
  • This method can not prevent the occurrence of OSAHS, because OSAHS is caused by the collapse of the soft palate and block the upper airway.
  • This method and the implanted device used cannot be used to treat OS AH So for patients with severe snoring, The increased mass of the soft palate swing increases the risk of OSAHS.
  • the idea of the present invention is: design an implant, one end fixed on the hard palate, one end implanted in the soft palate, supported by hard palate Point, lift the slack soft palate and part of the back of the tongue. By lifting the soft palate in the direction of the base of the tongue, the central axis of the natural sway of the soft palate is changed, thereby expanding the airway of the pharyngeal respiratory sputum, and achieving the purpose of treating snoring and OS AHS.
  • the soft palate support is as follows:
  • the adjustable soft palate support of the present invention is a flat implant made of a material that can be implanted in a human body for a long period of time, including: a support, a flat implant that can be inserted into a soft palate And a hard connecting end connecting the supporting body to the hard raft; the hard ⁇ connecting end comprises: a connecting structure arranged to fix the hard ⁇ connecting end to the hard ⁇ ; an adjusting mechanism configured to control the movement state of the supporting body Or curved The curvature, or the degree of lifting of the soft palate.
  • the support body has a curvature that matches the natural curvature of the soft palate of the human body.
  • connection structure on the hard-twist connection includes at least the following types of structures: a hole type structure, a U-clamp structure, a buckle type structure, a rivet type structure, and a self-expanding latch structure.
  • the adjusting mechanism on the hard connecting end is a switching mechanism including two states of opening or closing; when the adjusting mechanism is in an open state, the supporting body implanted in the soft palate can move with the natural swing of the soft palate; When the mechanism is in the closed state, the support body implanted in the soft palate can lift the soft palate, and by pushing the soft palate in the direction of the tongue root, the central axis of the soft palate is naturally changed, thereby expanding the airway of the paraphnea respiratory sputum.
  • the switch structure of the adjustment mechanism includes at least the following structure: a single-button switch structure, a double-key switch structure.
  • the adjustment mechanism on the hard-twisted end is a mechanism that can adjust the movement state of the support body or the degree of bending of the support or the degree of lifting of the soft palate.
  • the adjustment mechanism on the hard crotch connection end includes a first gear, a second gear or a second gear or more.
  • the adjustment mechanism on the hard-twisted end is a mechanism that can continuously adjust the movement state of the support body or the degree of bending or the degree of lifting of the soft palate.
  • the adjustment mechanism on the hard-twisted end includes a continuous adjustment mechanism that continuously adjusts the degree of softness of the support by rotational or linear motion.
  • the hard connecting end further comprises: a housing, wherein the adjusting mechanism is installed in the housing.
  • the adjustment mechanism on the hard-twist connection includes: an adjustment control button mounted on the housing, the adjustment control button covering a flexible polymer material film implantable in the human body.
  • the casing is provided with a flexible polymer material film implantable in a human body, and the adjustment control key is covered in the flexible polymer material film.
  • the support is a flat with or without holes.
  • the support is a structure selected from at least the following: a flat shape having an arc shape in cross section, a flat shape having a corrugated shape in cross section, and a flat shape having a rib.
  • the support body is provided with at least one elastic module.
  • the elastic module is deformable under the action of an external force, and can be restored after the external force is removed.
  • the shape or body of the front shape is deformable under the action of an external force, and can be restored after the external force is removed.
  • the elastic module comprises at least the following structure: an elastic polymer material sheet or a belt or a film, a spring structure, and a spring structure covered with a flexible polymer material.
  • the support body is provided with at least one rigid module.
  • the rigid module has a certain supporting force, but can be plastically deformed under excessive external force.
  • the support body may be coupled or detachably connected to the hard raft connection end.
  • the length of insertion of the support into the soft palate is between 1/5 and 4/5 of the total length of the soft palate, and the optimal insertion length is between 2/3 and 3/4.
  • the implantation method is to fix the hard palate connection end to the hard palate, and the support body is inserted into the soft palate.
  • the adjustable soft palate support is fixed on the hard palate due to the hard palate connection, and the support is implanted in the muscular layer of the soft palate, and the soft palate is supported by the hard palate, and the slack soft palate and part of the posterior tongue root are lifted.
  • the central axis of the natural sway of the soft palate is changed, thereby expanding the airway of the pharyngeal respiratory sputum and achieving the purpose of treating snoring and OSAHS.
  • the adjustment mechanism can be opened, and the support implanted in the soft palate can move with the natural swing of the soft palate, reducing interference with swallowing movements;
  • the adjustment mechanism In the sleep state, the adjustment mechanism is in the off state, and the support body implanted in the soft palate can lift the soft palate.
  • the central axis of the natural sway of the soft palate is changed, thereby expanding the airway of the pharyngeal respiratory sputum. This avoids the occurrence of snoring and OSAHS.
  • the present invention also designs an adjustable soft palate support that can be adjusted by means of a shift adjustment and a continuous adjustment, so that the control button implanted on the hard palate can be adjusted by a finger or a tongue or a remote controller, and the soft palate can be implanted.
  • the inner support body is adjusted to the proper position to maintain the normal phlegm and swallowing in the non-sleep state, and to ensure that the soft palate can be effectively lifted under the sleep state, to maintain the patency of the upper respiratory tract and to avoid the occurrence of snoring and OSAH S. .
  • the adjustable soft palate support of the present invention is extremelyly designed to be operated under local anesthesia or under general anesthesia. Surgical fistula, according to the severity of snoring and OSAHS, select different sizes of the adjustable soft palate support of the present invention, only need to cut a 2mm ⁇ 20mm small cut in the oral hard palate.
  • the oral joint of the adjustable soft palate support of the present invention is fixed on the hard palate, and the support is inserted into the soft palate, and the incision is sutured to complete the operation.
  • Minimally invasive surgery for the treatment of snoring and OSAHS was achieved.
  • Clinical application proves that the method of the invention and the implanted device have the advantages of small trauma, quick recovery, quick effect and reliable curative effect. In particular, after surgery, patients can easily adjust the degree of soft palate support by soft palate support according to their own feelings, in order to achieve the best therapeutic effect and comfort level, which is very popular among patients.
  • Figure 1 is a side cross-sectional view of the head of a human body through nasal breathing.
  • Figure 2 is a side cross-sectional view of the head of a swallowing human head.
  • FIG. 3 is a schematic diagram of the pathogenesis of OSAHS patients.
  • Figure 4 is a schematic diagram of the method of treating OSAHS provided by the present invention and the working principle of the adjustable soft palate support of the present invention.
  • Figure 5 is a schematic view showing the construction of an adjustable soft palate support of the present invention implanted in a hard palate and a soft palate with a single screw.
  • Figure 6 is a schematic view showing the structure in which the adjustable soft palate support of the present invention is implanted in a hard palate and a soft palate with double screws.
  • Figure 7 is a schematic view showing the construction of an adjustable soft palate support of the present invention implanted in a hard palate and a soft palate with three screws.
  • Fig. 8 is a schematic view showing the structure of the pusher type adjustable soft palate support in the "open” state according to the present invention.
  • the adjusting mechanism 12 uses a spring push rod type switch structure to push the push rod 50 toward the front teeth, and the adjusting mechanism 12 on the hard connecting end 1 is in an "open” state, and the supporting body 2 can be freely rotated around the rotating shaft 51. Rotating, so that the support body 2 can swing unconstrained with the swing of the soft palate.
  • FIG. 9 is a schematic view showing the structure of the push rod type adjustable soft palate support body in the "OFF" state according to the present invention.
  • the adjusting mechanism 12 uses a spring push rod type switch structure to push the push rod 50 toward the tongue root direction, and the adjusting mechanism 12 on the hard joint end 1 is in an "off" state, and the support body 2 is restrained and cannot be rotated.
  • the shaft 51 is free to rotate, thereby lifting the soft palate in the direction of the tongue root through the support body 2, changing the central axis of the soft palate swing.
  • the soft tissue of the soft palate can still oscillate within a certain range, but the swing is restrained on both sides of the support surface 2 with the support body 2, thereby expanding the respiratory tract of the pharynx by lifting the soft palate and part of the tongue base.
  • Fig. 10 is a schematic view showing the structure of the two-button type adjustable soft palate support in the "open” state according to the present invention.
  • the adjusting mechanism 12 uses a two-button switch structure, and the button 53 is pressed near the incisor direction, and the adjusting mechanism 12 on the hard connecting end 1 is in an "open” state, and the supporting body 2 can be freely rotated around the rotating shaft 51. Rotating, so that the support body 2 can swing unconstrained with the swing of the soft palate.
  • FIG 11 is a schematic view showing the structure of the two-button type adjustable soft palate support in the "OFF" state according to the present invention.
  • the adjusting mechanism 12 uses a two-button switch structure, and the button 54 is pressed near the tongue root direction, and the adjusting mechanism 12 on the hard connecting end 1 is in an "off" state, and the supporting body 2 is restrained and cannot be rotated.
  • the shaft 51 is free to rotate, thereby lifting the soft palate in the direction of the tongue root through the support body 2, changing the central axis of the soft palate swing.
  • the soft tissue of the soft palate can still oscillate within a certain range, but the swing is restrained on both sides of the support surface with the support body 2, thereby expanding the respiratory tract of the pharynx by lifting the soft palate and part of the base of the tongue to achieve treatment of snoring and OSAHS the goal of.
  • Fig. 12 is a view showing the structure of the rotary split type adjustable soft palate support in the "open” state according to the present invention.
  • the adjusting mechanism 12 uses a rotary switch split type structure. Rotating the rotary switch enables the support body 2 to move over a wide range, that is, the adjustment mechanism 12 on the hard-twisted connection end 1 is in an "open” state, and the support body 2 can freely rotate about the rotation axis 51, so that the support body 2 can follow Soft, swaying, unconstrained swing
  • FIG. 13 is a schematic view showing the structure of the rotary split type adjustable soft palate support in the "OFF" state according to the present invention.
  • the adjusting mechanism 12 uses a rotary split type positioning structure. Rotating the rotary switch limits the movement of the support body 2 to a small extent, that is, the adjustment mechanism 12 on the hard-twisted connection end 1 is in an "off" state, corresponding to different gear positions, the degree of support of the support body 2 to the soft palate different. Since the support body 2 is restrained and cannot be freely rotated about the rotation shaft 51 over a wide range, the soft palate is lifted toward the base of the tongue by the support body 2, and the central axis of the soft palate swing is changed.
  • the soft tissue of the soft palate can still oscillate within a certain range, but the swing is restrained on both sides of the support surface with the support body 2, thereby expanding the respiratory tract of the pharynx by lifting the soft palate and part of the base of the tongue to achieve treatment of snoring and OSAHS the goal of.
  • the adjusting mechanism 12 adopts a two-button three-step structure, and the button 53 ⁇ close to the incisor direction is pressed, and the adjusting mechanism 12 on the hard connecting end 1 is in an "open” state, and the supporting body 2 can be rotated.
  • the shaft 51 is free to rotate, so that the support body 2 can swing unconstrained with the swing of the soft palate.
  • Fig. 15 is a view showing the structure of the two-button three-step adjustable soft palate support in the "OFF" state according to the present invention.
  • the adjusting mechanism 12 uses a two-button three-speed switch structure, and the button 54 is pressed near the tongue root direction, and the adjusting mechanism 12 on the hard connecting end 1 is sequentially in the "off" state of different gear positions, corresponding to different In the gear position, the support body 2 has different degrees of lifting the soft palate. Since the support body 2 is restrained, it cannot be freely rotated about the rotation shaft 51, so that the soft palate is lifted toward the base of the tongue by the support body 2, and the central axis of the soft palate swing is changed.
  • the soft tissue of the soft palate can still oscillate within a certain range, but the swing is restrained on both sides of the support surface with the support body 2, thereby expanding the respiratory tract of the pharynx by lifting the soft palate and part of the base of the tongue to achieve treatment of snoring and OSAHS the goal of.
  • Fig. 16 is a view showing the structure of the linear translation type continuously adjusted soft palate support in the "open” state.
  • the adjusting mechanism 12 uses a slider type continuous positioning mechanism. Pushing the slider 59 straightly toward the incisors allows the support body 2 to move over a wide range, that is, the adjustment mechanism 12 on the hard-twisted connection end 1 is in an "open” state, and the support body 2 can freely rotate about the rotation axis 51. Thereby, the support body 2 can swing without restraint with the swing of the soft palate.
  • Fig. 17 is a view showing the structure of the linear translation type continuously adjusted soft palate support body in the "OFF" state according to the present invention.
  • the adjusting mechanism 12 uses a slider type continuous positioning mechanism. Pushing the slider 59 linearly in the direction of the base of the tongue, so that the movement of the support body 2 is restricted to a small range, that is, the adjustment mechanism 12 on the hard-twisted connection end 1 is in an "off" state, corresponding to different gear positions, the support body 2 The degree of lifting of the soft palate is different. Since the support body 2 is restrained, it cannot be freely rotated about the rotation shaft 51 over a wide range, so that the soft palate is lifted toward the base of the tongue by the support body 2, and the central axis of the soft palate swing is changed.
  • the soft tissue of the soft palate can still oscillate within a certain range, but the swing is restrained on both sides of the support surface with the support body 2, thereby expanding the respiratory tract of the pharynx by lifting the soft palate and part of the base of the tongue to achieve treatment of snoring and OSAHS the goal of.
  • Fig. 18 is a schematic view showing the structure in which the threaded support of the thread continuously adjusted according to the present invention is in an "open” state.
  • the adjusting mechanism 12 uses a thread positioning mechanism. Rotating the adjusting screw 61 outwardly enables the supporting body 2 to move in a wide range, that is, the adjusting mechanism 12 on the hard-twisting end 1 is in an "open” state, and the supporting body 2 can freely rotate about the rotating shaft 51, thereby supporting the body 2 can swing without constraint with the swing of the soft palate.
  • Fig. 19 is a structural schematic view showing the state in which the threaded continuous support soft palate support is "closed” according to the present invention.
  • the adjusting mechanism 12 uses a thread positioning mechanism. Rotate the adjustment screw 61 inward to support The movement of the body 2 is limited to a small extent, that is, the adjustment mechanism 12 on the hard-twist connection 1 is in an "off" state, corresponding to different gear positions, and the support body 2 has different degrees of lifting of the soft palate. Since the support body 2 is restrained, it is not free to rotate about the rotation shaft 51 over a wide range, so that the soft palate is lifted toward the base of the tongue by the support body 2, and the central axis of the soft palate swing is changed.
  • the soft tissue of the soft palate can still oscillate within a certain range, but the swing is restrained on both sides of the support surface with the support body 2, thereby expanding the respiratory tract of the pharynx by lifting the soft palate and part of the base of the tongue to achieve treatment of snoring and OSAHS the goal of.
  • 20 is a schematic view showing the structure of the electrically adjustable soft palate support of the present invention in an "open" state.
  • the adjusting mechanism 12 uses an electric positioning mechanism.
  • the electric adjustment control switch 64 By pressing the electric adjustment control switch 64, under the driving of the built-in power source 65, the electric device 63 can move the support body 2 through a transmission mechanism 66, that is, the adjustment mechanism 12 on the hard crotch connection end 1 is "on".
  • the support body 2 In a state, the support body 2 is freely rotatable about the rotation shaft 51, so that the support body 2 can swing unconstrainly with the swing of the soft palate.
  • Fig. 21 is a structural schematic view showing the state in which the threaded continuous support soft palate support is "closed” according to the present invention.
  • the adjusting mechanism 12 uses an electric positioning mechanism.
  • the electric adjustment control switch 64 By pressing the electric adjustment control switch 64, under the driving of the built-in power source 65, the electric device 63 can move the support body 2 in a small range by the transmission mechanism 66, that is, the adjustment mechanism 12 on the hard crotch connection end 1 is "off".
  • the support 2 holds the soft palate. Since the support body 2 is restrained, it cannot be freely rotated about the rotation shaft 51 over a wide range, so that the soft palate is lifted toward the base of the tongue by the support body 2, and the central axis of the soft palate swing is changed.
  • the soft tissue of the soft palate can still oscillate within a certain range, but the swing is restrained on both sides of the support surface with the support body 2, thereby expanding the respiratory tract of the pharynx by lifting the soft palate and part of the base of the tongue to achieve treatment of snoring and OSAHS the goal of.
  • FIG. 22 is a schematic view showing the structure of the electrically adjustable soft palate support in the "open” state according to the present invention.
  • This embodiment is basically the same as the embodiment 20 except that the built-in electric adjustment control switch 64 is replaced with a remote controller 67.
  • Fig. 23 is a structural schematic view showing the state in which the threaded continuous support soft palate support is "closed” according to the present invention.
  • This embodiment is basically the same as the embodiment 20 except that the built-in electric adjustment control switch 64 is replaced with a remote controller 67.
  • the connecting structure 11 in this embodiment is a combination of a through hole 69 for a fastener and a card edge 70.
  • Mounting ⁇ a slot in the hard cymbal 101 that coincides with the hard ⁇ connection 1 is placed, and the housing 124 of the adjustment mechanism 12 can be placed therein.
  • the hard-wired end 1 can be fixed to the hard palate 101 by the fasteners through the through-holes 69.
  • Figure 25 is a schematic view showing the structure of an adjustable soft palate support according to the present invention.
  • the connecting structure 11 is provided with a through hole structure, and three fastener through holes 69 for fixing the hard ⁇ connecting end 1 on the hard raft are distributed in a triangular shape at the bottom of the hard ⁇ connecting end 1 to constitute the connecting structure 11.
  • the hard-wired end 1 can be fastened to the hard jaw 101 by a through-hole 69 using a fastening screw 116.
  • Figure 26 is a schematic view showing the structure of the unfolded jaw of the convex and concave card-fit type adjustable adjustable soft palate support according to the present invention.
  • Figure 27 is a schematic view showing the structure of the embossed card-fit type adjustable adjustable soft palate support according to the present invention.
  • FIG. 28 is a schematic view showing the structure of the threaded type adjustable adjustable soft palate support body without assembling the crucible according to the present invention.
  • 29 is a schematic structural view of the screw type combined adjustable soft palate support according to the present invention after assembly.
  • Figure 30 is a schematic view showing the structure of an adjustable soft palate support according to the present invention.
  • the support body 2 has an arc shape in cross section, and the support body 2 has a good rigidity.
  • Figure 31 is a cross-sectional view taken along line A_A of Figure 30.
  • FIG 32 is a schematic structural view of an adjustable soft palate support according to the present invention.
  • the back side of the support body 2 has reinforcing ribs having two reinforcing ribs on its cross section, and the support body 2 has good rigidity.
  • Figure 33 is a cross-sectional view taken along line B_B of Figure 32.
  • Figure 34 is a schematic view showing the structure of an adjustable soft palate support according to the present invention.
  • the cross-section of the support body 2 is corrugated, and the support body 2 has a good rigidity.
  • Figure 35 is a cross-sectional view taken along line B_B of Figure 34.
  • 1 is a hard ⁇ connection end
  • 2 is a support body
  • 11 is a connection structure provided on the hard ⁇ connection end to fix the support body according to the present invention on the hard raft
  • 12 is provided on the hard ⁇ connection end
  • 121 is a switch structure
  • 12 2 is a step adjustment mechanism
  • 123 is a continuous adjustment mechanism
  • 124 is a housing of the adjustment mechanism
  • 125 is an adjustment control key
  • 126 is a medical flexible material film.
  • 20 is an elastic module
  • 21 is a through hole
  • 22 is a convex or concave or rough surface
  • 40 is a rigid module
  • 50 is a push rod
  • 51 is a rotating shaft
  • 52 is a return spring
  • 53 is close to the front teeth Button
  • 54 is the button near the base of the tongue
  • 55 is the split positioning block
  • 56 is the rotary adjustment switch
  • 57 is the split adjustment groove
  • 58 is the positioning block
  • 59 is the positioning slider
  • 60 is the adjustment lever
  • 61 is the adjustment Screw
  • 6 2 is the guide rod
  • 63 is the electric device
  • 64 is the electric adjustment control switch
  • 65 is the power supply
  • 66 is the transmission mechanism
  • 67 is the remote control
  • 68 is the circuit
  • 69 is the through hole for the fastening screw
  • 70 is the card side.
  • 101 is hard, 102 is soft, K is nasopharyngeal, 104 is the posterior of soft palate, 105 is epiglottis, 106 is esophagus, 107 is trachea, 10 8 is the front end of soft palate, 109 is support bone, 110 is nasal cavity, 111 is the oral cavity, 112 is the tongue, 113 is the hard palate-soft palate boundary line, 114 is the tongue root, 115 is the adjustable soft palate support body of the present invention, 116 is the fastener.
  • Figure 1 is a side cross-sectional view of the head of a human body through nasal breathing. People are breathing, soft palate 102 naturally drooping, epiglottis 1
  • air can pass through the nasal cavity 110 or open the mouth through the oral cavity 111, into the trachea 107.
  • Figure 2 is a side cross-sectional view of the head of a swallowing human head. The person swallows, the soft palate 102 sticks back, closes the nasopharynx
  • FIG. 3 is a schematic diagram of the pathogenesis of OSAHS patients.
  • the idea of treating the disease of the present invention is: designing an implant having one end fixed on the hard palate and one end implanted in the soft palate, With the hard palate support point, the soft tissue of the slack collapse and the soft tissue of the part of the back of the tongue are lifted up. By lifting the soft palate in the direction of the base of the tongue, the central axis of the natural sway of the soft palate is changed, thereby expanding the airway of the pharyngeal respiratory sputum. Achieve the goal of treating snoring and OSAHS. Since the swallowing action is more frequent in non-sleep conditions, especially eating sputum; and the sleep sputum swallowing action is less, we have disclosed an adjustable soft palate support in the present invention.
  • the adjustable soft palate support of the present invention is a flat-shaped implant made of a material that can be implanted for a long period of time in a human body, and is composed of a hard palate connecting end 1 and a support body 2.
  • the support body 2 is a flat implant that can be inserted into the soft palate; the hard palate connection end 1 is provided with a connection structure 11 for fixing the support body 115 of the present invention on the hard palate, and the control support body 2
  • the degree of lifting is a flat-shaped implant made of a material that can be implanted for a long period of time in a human body, and is composed of a hard palate connecting end 1 and a support body 2.
  • the support body 2 is a flat
  • the adjustable soft palate support of the present invention is fixed on the hard palate 101 by the hard palate connection end 1, and the support body 2 is implanted in the muscular layer of the soft palate, with the hard palate 101 supporting the point, and the loosely collapsed soft palate 102 and the tongue Part of the soft tissue of the posterior root is lifted.
  • the central axis of the natural sway of the soft palate is changed, thereby expanding the airway of the pharyngeal respiratory sputum, and achieving the purpose of treating snoring and OSAHS.
  • the adjusting mechanism 12 of the adjustable soft palate support body can be in the "on" state, and the support body 2 implanted in the soft palate can move with the natural swing of the soft palate 102.
  • the support body 2 implanted in the soft palate can lift the soft palate, by lifting the soft palate in the direction of the tongue root , changed the central axis of the natural sway of the soft palate, thereby expanding the airway of the pharyngeal respiratory sputum.
  • the present invention also designs an adjustable soft palate support that can be adjusted by a shifting and continuously adjustable, so that the control button 125 implanted on the hard palate can be adjusted by a finger or a tongue or a remote control switch, and the implant can be implanted.
  • the support body 2 in the soft palate is adjusted in an appropriate position to maintain normal phlegm and swallowing in a non-sleep state, and to ensure that the soft palate can be effectively lifted in a sleep state, to maintain sleep, to patency of the upper respiratory tract, and to avoid snoring and OS AHS. happened.
  • the adjustable soft palate support of the present invention is extremely designed to be operated under local anesthesia or under general anesthesia. Surgical fistula, according to the severity of snoring and OSAHS, select different sizes of the adjustable soft palate support of the present invention, only need to cut a small incision of 2mm ⁇ 20mm in the oral hard palate, and adjust the invention according to the invention
  • the hard ⁇ connection end 1 of the soft raft support is fixed on the hard raft 101, and the branch
  • the support 2 is inserted into the muscular layer of the soft palate 102, and the incision is sutured to complete the operation. Minimally invasive surgery for the treatment of snoring and OSAHS was achieved.
  • the adjustable soft palate support of the present invention can be implanted in the hard palate and the soft palate with a single screw, see FIG. 5; the adjustable soft palate support of the present invention can also be implanted in the hard palate with double screws. And soft palate, see Figure 6; the adjustable soft palate support of the present invention can also be implanted in the hard palate and soft palate with three screws, see Figure 7.
  • the method and the implanted device of the invention have the advantages of small trauma, quick recovery, quick effect and reliable curative effect. In particular, after surgery, the patient can easily adjust the degree of soft palate support by soft palate support according to his or her own feeling, in order to achieve the best therapeutic effect and comfort.
  • Embodiment 1 The push rod type adjustable soft palate support body of the present invention
  • the medical grade titanium and the medical titanium alloy which can be implanted in the human body for a long time are selected, and the product of the present invention is manufactured according to the general processing technology of the titanium metal product.
  • the support body 2 is made of a titanium metal plate having a thickness of 0.6 mm to 1 mm, and the titanium metal plate is bent to have a curvature matching the natural curvature of the soft palate of the human body, and is processed in a titanium metal plate.
  • the through hole 21 and the small through hole 21 have a diameter of 0.5 mm to 2 mm, which facilitates tissue growth and penetration.
  • Hard ⁇ connection 1 ⁇ Made of titanium to make the hard end 1 .
  • connection structure 11 In the present embodiment, a through hole which can pass through a screw having a diameter of 4 mm is formed on the hard-twist joint 1 as the joint structure 11.
  • the adjustable soft palate support 115 of the present invention can be attached to the hard palate 101 by the attachment structure 11 using titanium fastening screws 116.
  • Adjustment mechanism 12 In this embodiment, the adjustment mechanism 12 in this embodiment uses a spring push rod type switch structure
  • the adjusting mechanism 12 is constituted by a push rod 50, a rotating shaft 51, a return spring 52, an adjusting lever 60, a positioning block 58, a housing 124, a medical flexible material film 126, and the like.
  • the push rod 50 constitutes the switch structure 121 and the adjustment control button 125 together with the return spring 52, the adjustment rod 60 and the like.
  • the support body 2 is free to rotate about the rotation axis 51, so that the support body 2 can swing without the bundle with the swing of the soft palate, see Fig. 8.
  • materials that can be used to manufacture the support 2 include, but are not limited to: titanium metal, titanium alloy, Nitinol alloy, medical stainless steel, other medical metal materials, and medical polymer materials, which can be implanted in the human body for a long time. .
  • Materials that can be used to make hard-wired joints 1 include, but are not limited to, titanium, titanium alloys, Nitinol alloys, medical stainless steels, other medical metal materials, and medical polymer materials that can be implanted in the human body for a long time.
  • Flexible polymeric materials that can be used to make medical flexible material films 126 include, but are not limited to: medical silicone
  • Materials that can be used to make the fastener 116 include, but are not limited to: titanium metal, titanium alloy, Nitinol alloy
  • medical stainless steel, other medical metal materials and medical polymer materials can be implanted in the human body for a long time.
  • Embodiment 2 The two-button adjustable soft palate support of the present invention
  • a medical metal material which can be implanted in a human body for a long period of time is selected, and the product of the present invention is manufactured according to a general processing technique of a medical metal product.
  • the support body 2 is made of a titanium-nickel shape memory alloy plate having a thickness of 0.6 mm to 1 mm, and the titanium-nickel shape memory alloy plate has a curvature matching the natural curvature of the soft palate of the human body by a shaping heat treatment, and A convex or concave surface or a rough surface 22 is formed on the surface to facilitate tissue growth and adhesion.
  • Hard ⁇ connection 1 ⁇ Made of titanium to make the hard end 1 .
  • Connection structure 11 In the present embodiment, a through hole which can pass through a screw having a diameter of 4 mm is formed on the hard-twist joint 1 as the joint structure 11.
  • the adjustable soft palate support 115 of the present invention can be secured to the hard palate 101 by the attachment structure 11 with a titanium fastening screw 116.
  • Adjustment mechanism 12 In this embodiment, the adjustment mechanism 12 in this embodiment uses a two-button switch structure.
  • the button 53 near the incisor direction, the button 54 near the tongue root direction, the index positioning block 55, the rotating shaft 51, the return spring 52, the adjusting rod 60, the positioning block 58, the housing 124, the medical flexible material film 126, etc. constitute an adjustment Agency 12.
  • the button 53 near the incisor direction, the button 54 near the tongue root direction, and the return spring 52, the adjusting rod 60, the bin positioning block 55, and the like constitute the switch structure 121, and the adjustment control button 12
  • Embodiment 3 The rotary split type adjustable soft palate support according to the present invention
  • a medical metal material that can be implanted in a human body for a long period of time is selected, and the product of the present invention is manufactured according to a general processing technique of a medical metal product.
  • the support body 2 is made of a titanium-nickel shape memory alloy plate having a thickness of 0.6 mm to 1 mm, and a micro through hole 21 is processed in the metal plate, and the diameter of the small through hole 21 is between 0.5 mm and 2 mm to facilitate tissue growth. penetration.
  • the titanium-nickel shape memory alloy plate has a curvature matching the natural curvature of the soft palate of the human body.
  • Hard ⁇ connection 1 ⁇ Made of titanium to make the hard end 1 .
  • connection structure 11 In the present embodiment, a through hole which can pass through a screw having a diameter of 4 mm is formed on the hard-twist joint 1 as the joint structure 11.
  • the adjustable soft palate support 115 of the present invention can be attached to the hard palate 101 by the attachment structure 11 using titanium fastening screws 116.
  • Adjustment mechanism 12 In the present embodiment, the adjustment mechanism 12 in this embodiment uses a rotary switch split type structure.
  • the rotation rotation adjustment switch 56 By the rotation rotation adjustment switch 56, the index positioning block 55, the rotation shaft 51, the return spring 52, the adjustment rod 60
  • the positioning block 58, the housing 124, the medical flexible material film 126, and the like constitute the adjustment mechanism 12.
  • the rotary rotation adjustment switch 56 is configured to form a switch structure 121 and an adjustment control key 125 with the split positioning block 55, the return spring 52, the adjustment lever 60, and the like.
  • the rotation adjustment switch 56 is rotated to enable the support body 2 to move in a wide range, that is, the adjustment mechanism 12 on the hard ⁇ connection end 1 is in an "open" state, and the support body 2 can be rotated around the rotation axis. 51 is free to rotate, so that the support body 2 can swing unconstrained with the swing of the soft palate, see Fig. 12.
  • the rotation adjustment switch 56 is rotated to restrict the movement of the support body 2 to a small range, that is, the adjustment mechanism 12 on the hard-twist connection end 1 is in the "off" state, corresponding to different gear positions, supporting Body 2 has different degrees of lifting of soft palate. Since the support body 2 is restrained, it is not free to rotate about the rotation shaft 51 over a wide range, so that the soft palate is lifted toward the base of the tongue by the support body 2, and the central axis of the soft palate swing is changed.
  • the soft tissue of the soft palate can still oscillate within a certain range, but the swing is restrained on both sides of the support surface with the support body 2, thereby expanding the respiratory tract of the pharynx by lifting the soft palate and part of the base of the tongue to achieve treatment of snoring and OSA.
  • HS refer to Figure 13.
  • Embodiment 4 Two-button three-step adjustable soft palate support according to the present invention
  • the adjusting mechanism 12 uses a two-button three-step structure, and its structure is basically the same as that of the second embodiment, and the difference is that:
  • the tail portion of the support body 2 is modified in an alternating manner with the rigid module 40 to improve the flexibility of the tail portion of the support body 2.
  • the adjustment mechanism 12 uses a two-button three-speed structure.
  • the split adjustment groove 57 and the split positioning block 55 are manufactured on one part, and three gear positions can be adjusted.
  • the range of motion of the support body 2 is different from the degree of lifting the soft palate.
  • the adjustment mechanism 12 on the hard end connection 1 is in the "off" state of different gears in sequence, corresponding to different gear positions, the supporting body 2 is soft to the support The degree is different. Since the support body 2 is restrained, it cannot be freely rotated about the rotation shaft 51, so that the soft palate is lifted toward the base of the tongue by the support body 2, and the central axis of the soft palate swing is changed.
  • Soft tissue soft tissue can still be in a certain range The inner swing, but the swing is restrained on both sides of the support body 2 as a support surface, thereby expanding the respiratory tract of the pharynx by lifting the soft palate and part of the tongue base, thereby achieving the purpose of treating hysteria and OSAHS.
  • Embodiment 5 Linear translation type continuously adjusted soft palate support according to the present invention
  • the present embodiment is characterized in that: the adjustment mechanism 12 uses the slider type continuous adjustment mechanism 123 to continuously adjust the degree to which the support body 2 holds up the soft palate by the parallel movement of the slider 59.
  • the elastic module 20 of the tail portion of the support body 2 is configured by a close-packed coil spring structure.
  • the slider 59 is linearly pushed away from the base of the tongue to restrict the movement of the support body 2 to a small range, that is, the adjustment mechanism 12 on the hard-wired connection end 1 is in the "off" state, corresponding to different In the gear position, the support body 2 has different degrees of lifting the soft palate. Since the support body 2 is restrained, it is not free to rotate about the rotation shaft 51 over a wide range, so that the soft palate is lifted toward the base of the tongue by the support body 2, and the central axis of the soft palate swing is changed.
  • the soft tissue of the soft palate can still oscillate within a certain range, but the swing is restrained on both sides of the support surface with the support body 2, thereby expanding the respiratory tract of the pharynx by lifting the soft palate and part of the base of the tongue to achieve treatment of snoring and OSAHS
  • Figure 17 For the purpose, refer to Figure 17.
  • Example 6 The threaded continuous adjustable soft palate support of the present invention
  • the adjusting mechanism 12 uses a thread positioning mechanism, and by rotating the adjusting screw 61, the movement state or bending curvature of the support body 2 can be conveniently controlled, or the degree of lifting of the soft palate can be controlled. .
  • the elastic module 20 of the tail portion of the support body 2 is covered with a medical flexible polymer material to cover the close-packed spiral spring structure.
  • the adjusting mechanism 12 of the embodiment is adjusted by the rotation adjusting screw 61, the guiding rod 62, the positioning slider 59, the positioning block 58, the rotating shaft 51, the adjusting rod 60, the casing 124, the medical flexible material film 126, and the like.
  • Agency 12 The adjusting screw 61 is composed of a guiding rod 62, a positioning slider 59, a positioning rod 58 adjusting rod 60, and the like, and constitutes a continuous adjusting mechanism 123, and an adjusting control button 125, referring to FIG.
  • the adjusting screw 61 is rotated outward to enable the support body 2 to move over a wide range, that is, the adjusting mechanism 12 on the hard ⁇ connecting end 1 is in an "open" state, and the supporting body 2 can be rotated.
  • the shaft 51 is free to rotate, from The support 2 can swing unconstrained with the swing of the soft palate, see Fig. 18.
  • the adjusting screw 61 is rotated inward to restrict the movement of the supporting body 2 to a small range, that is, the adjusting mechanism 12 on the hard connecting end 1 is in an "off" state, corresponding to different gear positions,
  • the support body 2 has different degrees of lifting of the soft palate. Since the support body 2 is restrained, it is not free to rotate about the rotation shaft 51 over a wide range, so that the soft palate is lifted toward the base of the tongue by the support body 2, and the central axis of the soft palate swing is changed.
  • the soft tissue of the soft palate can still oscillate within a certain range, but the swing is restrained on both sides of the support surface with the support body 2, thereby expanding the respiratory tract of the pharynx by lifting the soft palate and part of the base of the tongue to achieve treatment of snoring and OSA.
  • the purpose of the HS Refer to Figure 19.
  • Example 7 The electrically adjustable soft palate support of the present invention
  • the adjusting mechanism 12 uses an electric positioning mechanism, which is composed of a power source 65, a circuit 68, an electric device 63, a transmission mechanism 66, and an electric adjustment control switch 64.
  • the power source 65, the circuit 68, the electric device 63, and the transmission mechanism The 66 is built into the housing 124 of the adjustment mechanism.
  • the electric adjustment control switch 64 is disposed on the housing 124 and covered by the medical flexible material film 126.
  • Non-sleep state ⁇ pressing the electric adjustment control switch 64, driven by the built-in power source 65 and the circuit 68, the electric device 63 can move the support body 2 over a wide range by the transmission mechanism 66, that is, the hard ⁇ connection end
  • the adjustment mechanism 12 on 1 is in an "open" state, and the support body 2 is freely rotatable about the rotation shaft 51, so that the support body 2 can swing unconstrainly with the swing of the soft palate.
  • the electric adjustment control switch 64 Before sleep, the electric adjustment control switch 64 is pressed, and under the control and driving of the built-in power source 65 and the circuit 68, the electric device 63 can move the support body 2 in a small range through the transmission mechanism 66, that is, the hard-wire connection end.
  • the adjustment mechanism 12 on 1 is in the "off" state, and the support 2 holds the soft palate. Since the support body 2 is restrained, it is not freely rotatable about the rotation shaft 51 over a wide range, so that the soft palate is lifted toward the base of the tongue by the support body 2, and the central axis of the soft palate swing is changed.
  • the soft tissue of the soft palate can still oscillate within a certain range, but the swing is restrained on both sides of the support surface with the support body 2, thereby expanding the respiratory tract of the pharynx by lifting the soft palate and part of the base of the tongue to achieve treatment of snoring and OSAHS
  • Figure 21 For the purpose, refer to Figure 21.
  • the present embodiment can be modified to become a remote controller control, and the circuit 68 and the electric adjustment control switch 64 are modified in accordance with the wireless remote control mode, that is, can be controlled by the remote controller 67, referring to Figs. 22 to 23.
  • Embodiment 8 The combined adjustable soft palate support of the present invention
  • the hard palate connection 1 and the support 2 can be clinically implanted in stages.
  • the hard-wired end 1 is fixed to the hard raft 101 by fasteners 116.
  • the fixation between the hard palate connection 1 and the hard palate 101 is already firm, and another operation is performed to insert the support 2 into the soft palate 102, and the support 2 is simultaneously
  • the adjustment mechanism 12 at the proximal end and the hard-wired connection 1 is coupled by a male or female card or by fasteners.
  • the support of the present invention is designed with a male and female card fit type (refer to Figs. 26 to 27) or a fastener connection type (refer to Figs. 28 and 29).
  • the combined adjustable soft palate support of the present invention is provided on the adjustment mechanism 12 of the hard palate connection end 1 with a connection structure capable of forming a card fit with the proximal end of the support body 2, and the support body 2 can be conveniently fixed.
  • a connection structure capable of forming a card fit with the proximal end of the support body 2, and the support body 2 can be conveniently fixed.
  • Figs. 26 to 27 On the hard end connection 1, reference is made to Figs. 26 to 27.
  • the combined adjustable soft palate support of the present invention is provided with a mechanism for coupling the proximal end of the support body 2 to the support mechanism 2 at the proximal end of the support body 2.
  • Most of the fasteners used are titanium screws or rivets or positioning blocks. Refer to Figure 28 and Figure 29.
  • the cross section of the flat support body 2 may be curved, or corrugated, or a conventional method of increasing the rigidity of the flat object using a reinforcing rib or the like.
  • Example 9 The support body of the present invention has a curved soft palate support in cross section
  • the cross section of the support body 2 is curved.
  • the support of the curved cross section 2 has the advantage of having a good stiffness.
  • the support body 2 has a curved cross section and a rectangular cross section, and has a better rigidity.
  • the rigidity of the support body 2 can be improved, referring to FIG. 32, FIG. 33; or, the support body The stamping of 2 is corrugated or wavy, and the rigidity of the support 2 can also be improved, referring to Figs. 34 and 35.

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Description

Title of Invention:可调节的软腭支撑体及植入方法
技术领域
技术领域
本发明涉及一种可调节的软腭支撑体， 特别是用于治疗成人阻塞性睡眠呼吸暂 停低通气综合征 (Obstructive sleep apnea/hypopnea syndrome, OSAHS ) 和鼻干症的 可调节的软腭支撑体及植入方法。
背景技术
背景技术
成人阻塞性睡眠呼吸暂停低通气综合征 （Obstructive sleep apnea/hypopnea syndrome, OSAHS) 是由于睡眠吋上气道出现塌陷堵塞而引起的一种以打鼾和呼 吸暂停为临床特征的睡眠呼吸障碍性疾病。 即使按照最低的诊断标准， OSAHS 的患病率在成人男性中约 4%， 女性约 2%， 严重威胁着患者的生命健康。
[3] 对于 OSAHS的发病机理， 一般认为主要原因是由于睡眠吋维持上气道幵放的 扩咽肌松弛出现软组织塌陷阻塞， 阻塞平面多位于软腭、 扁桃体及舌根。 治疗 0 SAHS的方法有很多， 分为非手术治疗和手术治疗两类。
[4] 非手术治疗方法主要有：
[5] 1、 持续正压通气 （CPAP) 。 即由一种能持续产生正压的呼吸机通过鼻罩与病 人鼻面部紧密连接， 用于解除睡眠吋气道软组织塌陷阻塞。 该方法虽然效果较 好， 但约有 2/3的患者难以适应， 无法戴着呼吸机睡眠。
[6] 2、 口腔矫治器。 通过在口内安放一种装置， 使下颌前移或者舌头前拉， 扩大 咽腔， 解除睡眠吋气道阻塞。 该方法有多种类型， 有一定的效果， 但多数患者 难以适应。 口腔矫治器有一定的刺激性和异物感， 另人无法入眠， 长期使用还 可引起颞颌关节损伤。
[7] 在国际申请 PCT/US2005/00139中公幵了一种用于减缓上呼吸道阻塞的方法和装 置， 该装置是适于人口中形成密封腔的口具， 在睡眠吋咬具该装置， 在人口中 形成密封腔， 负压发生器连接该装置， 将病人的舌头和 /或上呼吸道的软组织拉 起或拉离咽底以大开呼吸道， 减少 OSAHS发生。
[8] 在中国实用新型专利 ZL200620110299.7中公开了一种舌前移器， 用于治疗 OSA
HS和鼾症。 这种舌前移器包括一个半月型底座， 底座的上部具有由前后凸边构 成的半月形上牙托槽； 在底座的下部具有弧型后档板， 底座的正中心具有一贯 通前后缘的锚舌孔； 在底座的下部具有弧型前档板， 在前后档板之间构成下前 牙列的托架。 这种舌前移器为患者的上下前牙列提供一个主动的咬合模具， 使 上下的肌肉在睡眠吋下意识的始终处于一种相对紧张状态， 这样上下颌与舌前 移器形成一个稳定的支点； 锚舌孔为舌尖提供一个舒适的锚定位置， 将舌规范 于锚舌孔与舌骨之间， 保持了口咽部气道的通畅， 从而达到治疗 OSAHS和鼾症 的目的。
[9] 类似于国际申请 PCT/US2005/001392005.1.3中公开的装置或中国实用新型专利
ZL200620110299.7中公开的舌前移器的专利还有许多， 这些专利都是在口腔中 利用牙齿为支撑点， 设计了各种器具来改变睡眠吋舌头或者软腭的紧张程度或 位置， 从而达到治疗 OSAHS和鼾症的目的。 这些器具要在睡眠前放入口腔中并 咬合固定， 但人在睡眠吋是不断变换姿势和口型的， 这些器具吋常不能发挥有 效的功能， 此外， 患者使用吋也不舒适、 不方便。
[10] 手术治疗治疗方法主要有：
[11] 1、 射频消融术， 也称低温等离子射频消融， 是一种微创手术方法。 主要是将 电极刺入引起气道阻塞的软组织中， 如软腭、 扁桃体及舌根等部位， 通电加热 使组织凝固、 坏死、 纤维化、 收缩。 有一定的治疗作用， 对较轻的病例有效， 远期疗效欠佳， 对重度病人无效。
[12] 2、 腭咽成形。 1981年 Fujita把日本学者 Ikematus的腭咽成形术改进为悬雍垂腭 咽成形术 （uvulopalatopharyngoplasty，UPPP) 并引进美国后， 文献已相继报道了 以 UPPP为基础的多种改良术式， 包括 Simmons法、 Fairbanks法、 Dickson法、 Wo odson法、 Z型腭成形术、 悬雍垂腭瓣术、 保留悬雍垂的腭咽成形术 （H-UPPP) 等， 其对改善 OSAHS患者的症状及愈后做出了巨大的贡献。 虽然外科治疗手段 使无数患者收益， 但长期效果看， 因过度切除黏膜、 软腭组织结构， 损伤功能 性肌肉， 造成吞咽吋鼻腔反流、 开放性鼻音、 鼻咽腔狭窄闭锁等并发症。 如何 开创一种创伤更小， 或者以微创的方式进行的手术治疗的方法和相应的手术器 械， 也就成为当今 OS AHS治疗技术研究、 发展的前沿和重点。
[13] 3、 软腭植入术。 在国际申请 PCT/US2002/0079662002.3.14中公开了一种治疗打 鼾的编织的软腭植入物， 该发明在软腭植入利用编织物来改变软腭随气流摆动 吋的重心及改变软腭的空气动力学特点， 以提高软腭和咽部的临界空气流速， 从而防止鼾症的发生。 但是这种方法无法防止 OSAHS的发生， 因为 OSAHS是由 于软腭塌陷堵塞上气道而弓 I起， 这种方法和所用的植入器械不能用于治疗 OS AH So 对于重症鼾症患者而言， 由于软腭摆动部位的质量增加， 反而增加了 OSAHS 发生的风险。
[14] 综上所述， 现有技术方法治疗 OSAHS和鼾症， 虽然有一定效果， 但仍然有许 多缺陷， 远期效果欠佳。 需要开创新的方法和设计新的器械来治疗 OSAHS和鼾 症， 这种新方法创伤要尽可能小， 新器械要安全、 有效、 简单、 可靠。
对发明的公开
技术问题
[15] 研究报告和临床经验表明： 软腭部分的松弛塌陷是造成鼾症和 OSAHS的主要 原因。
[16] 针对这一因软腭部分的松弛塌陷而造成鼾症和 OSAHS的致病原因， 本发明的 思路是： 设计一种植入体， 一端固定在硬腭上， 一端植入软腭中， 以硬腭支撑 点， 将松弛塌陷的软腭和部分舌后根托起。 通过向舌根方向托起软腭， 改变了 软腭自然摆动吋的中轴线， 从而扩大了咽部呼吸吋的气道， 达到治疗鼾症和 OS AHS的目的。 由于白天非睡眠状况下吞咽动作较频繁， 特别是进食吋， 而因软 腭部分的松弛塌陷而造成的鼾症和 OSAHS发生在睡眠吋， 睡眠吋吞咽动作较少 ， 故本发明设计了可调节的软腭支撑体， 具体如下：
技术解决方案
[17] 本发明所述的可调节的软腭支撑体， 是用能在人体中长期植入的材料制造的扁 平状植入物， 包括： 支撑体， 是能插入软腭内的扁平状植入物； 以及硬腭连接 端， 将所述支撑体连接到硬腭； 所述硬腭连接端包括： 连接结构， 设置为使所 述硬腭连接端固定于硬腭； 调节机构， 设置为控制所述支撑体的运动状态或弯 曲弧度， 或控制软腭的托起程度。
[18] 进一步， 所述支撑体具有与人体软腭松弛吋的自然弯曲度相匹配的弧度。
[19] 所述硬腭连接端上的连接结构至少包括以下类型的结构： 孔型结构， U型夹结 构， 扣型结构， 铆钉式结构， 以及自膨胀卡锁结构。
[20] 所述硬腭连接端上的调节机构是包括开或关两种状态的开关机构； 当调节机构 在开的状态下， 植入软腭内的支撑体能随软腭的自然摆动而运动； 当调节机构 在关的状态下， 植入软腭内的支撑体能将软腭托起， 通过向舌根方向托起软腭 ， 改变了软腭自然摆动吋的中轴线， 从而扩大了咽部呼吸吋的气道。
[21] 进一步， 所述调节机构的开关结构， 至少包括以下结构： 单键开关结构， 双键 开关结构。
[22] 所述硬腭连接端上的调节机构是能分档调节支撑体的运动状态或弯曲弧度或软 腭的托起程度的机构。
[23] 进一步， 所述硬腭连接端上的调节机构包括一档， 二档或二档以上的分档调节 机构。
[24] 所述硬腭连接端上的调节机构是能连续调节支撑体的运动状态或弯曲弧度或软 腭的托起程度的机构。
[25] 所述硬腭连接端上的调节机构包括通过旋转运动或直线运动来连续调节支撑体 托起软腭程度的连续调节机构。
[26] 进一步， 所述硬腭连接端还包括： 壳体， 所述调节机构安装在壳体内。
[27] 所述硬腭连接端上的调节机构包括： 调节控制键， 安装在壳体上， 所述调节控 制键上覆盖能在人体中植入的柔性高分子材料膜。
[28] 所述壳体上装有能在人体中植入的柔性高分子材料膜， 所述调节控制键上覆盖 在所述柔性高分子材料膜内。
[29] 所述支撑体是带孔或不带孔的扁平状物。
[30] 进一步， 所述支撑体是选自至少以下的结构： 横截面为弧性的扁平状物， 横截 面为瓦楞形的扁平状物， 以及带加强筋的扁平状物。
[31] 所述支撑体设有至少一个弹性模块。
[32] 进一步， 所述弹性模块是在外力作用下能变形、 且在外力卸除后又能恢复变形 前的形状的机构或物体。
[33] 所述弹性模块至少包括以下结构： 弹性高分子材料薄板或带或膜， 弹簧结构， 被柔性高分子材料包覆的弹簧结构。
[34] 所述支撑体设有至少一个刚性模块。
[35] 进一步， 所述刚性模块是有一定支撑力， 但在过度外力作用下能发生塑性变形
、 外力卸除后不能恢复变形前形状的机构或物体。
[36] 所述支撑体可组合或装拆地与硬腭连接端连接。
[37] 所述支撑体插入软腭的长度在软腭总长度的 1/5至 4/5之间， 其最佳插入长度在 2 /3至 3/4之间。
[38] 所述植入方法是将硬腭连接端固定在硬腭上， 而支撑体插入软腭中。
有益效果
[39] 可调节的软腭支撑体由于硬腭连接端固定在硬腭上， 支撑体植入软腭的肌层中 ， 以硬腭支撑点， 将松弛塌陷的软腭和部分舌后根部托起。 通过向舌根方向托 起软腭， 改变了软腭自然摆动吋的中轴线， 从而扩大了咽部呼吸吋的气道， 达 到治疗鼾症和 OSAHS的目的。 因白天非睡眠状况下吞咽动作较频繁， 特别是进 食吋， 可以使调节机构处于开的状态， 植入软腭内的支撑体能随软腭的自然摆 动而运动， 减少对吞咽动作的干扰； 而当进入睡眠状态吋， 将调节机构处于关 的状态， 植入软腭内的支撑体能将软腭托起。 通过向舌根方向托起软腭， 改变 了软腭自然摆动吋的中轴线， 从而扩大了咽部呼吸吋的气道。 从而避免了鼾症 和 OSAHS的发生。
[40] 进一步， 本发明还设计了分档调节和能连续调节的可调节的软腭支撑体， 这样 通过手指或者舌尖或遥控器来调节植入在硬腭上的控制键， 就可以将植入软腭 内的支撑体调节到适当位置， 既保持非睡眠状态下吋吞咽的正常， 又能在睡眠 状态下保证能有效托起软腭， 保持睡眠吋上呼吸道的通畅， 避免了鼾症和 OSAH S的发生。
[41] 本发明所述的可调节的软腭支撑体， 设计精巧， 既可以在局部麻醉下手术， 也 可以在全麻醉下手术。 手术吋， 依据鼾症和 OSAHS严重程度， 选择不同大小的 本发明所述的可调节的软腭支体， 仅需在口腔硬腭处切开一个 2mm〜20mm小切 口， 将本发明所述的可调节的软腭支撑体的硬腭连接端固定在硬腭上， 而支撑 体插入软腭中， 缝合切口即可完成手术。 实现了微创手术治疗鼾症和 OSAHS的 目的。 临床应用证明， 釆用本发明的方法和植入的器械， 具有创伤小， 恢复快 ， 见效快， 疗效可靠的优点。 特别是手术后患者可以根据自身的感觉来方便地 调节软腭支撑体托起软腭的程度， 以达到最佳治疗效果和舒适程度， 深受患者 的欢迎。
附图说明
[42] 图 1是经鼻呼吸吋人体头部侧面剖视图。
[43] 图 2是吞咽吋人体头部侧面剖视图。
[44] 图 3是 OSAHS患者的发病吋的机理图。
[45] 图 4是本发明提供的治疗 OSAHS的方法原理图和本发明所述的可调节的软腭支 撑体的工作原理图。
[46] 图 5是用单螺钉固定本发明所述的可调节的软腭支撑体植入在硬腭和软腭中的 结构示意图。
[47] 图 6是用双螺钉固定本发明所述的可调节的软腭支撑体植入在硬腭和软腭中的 结构示意图。
[48] 图 7是用三螺钉固定本发明所述的可调节的软腭支撑体植入在硬腭和软腭中的 结构示意图。
[49] 图 8是本发明所述的推杆式可调节的软腭支撑体处于 "开"的状态吋的结构示意 图。 本实施例中调节机构 12釆用弹簧推杆式开关结构， 将推杆 50推向门牙方向 ， 硬腭连接端 1上的调节机构 12处于"开"的状态， 支撑体 2能绕转动轴 51自由转动 ， 从而支撑体 2能随软腭的摆动而无约束的摆动。
[50] 图 9是本发明所述的推杆式可调节的软腭支撑体处于 "关"的状态吋的结构示意 图。 本实施例中调节机构 12釆用弹簧推杆式开关结构， 将推杆 50推向舌根方向 ， 硬腭连接端 1上的调节机构 12处于"关"的状态， 支撑体 2受到约束， 不能绕转动 轴 51自由转动， 从而通过支撑体 2将软腭向舌根方向托起， 改变了软腭摆动的中 轴线。 软腭的软组织仍然可以在一定范围内摆动， 但摆动被约束在以支撑体 2为 支撑面的两侧， 从而通过托起软腭和部分舌根部， 扩大了咽部的呼吸道，达到治 疗鼾症和 OSAHS的目的。
[51] 图 10是本发明所述的双按钮式可调节的软腭支撑体处于"开"的状态吋的结构示 意图。 本实施例中调节机构 12釆用双按钮式开关结构， 按下靠近门牙方向的按 钮 53吋， 硬腭连接端 1上的调节机构 12处于"开"的状态， 支撑体 2能绕转动轴 51自 由转动， 从而支撑体 2能随软腭的摆动而无约束的摆动。
[52] 图 11是本发明所述的双按钮式可调节的软腭支撑体处于"关"的状态吋的结构示 意图。 本实施例中调节机构 12釆用双按钮式开关结构， 按下靠近舌根方向的按 钮 54吋， 硬腭连接端 1上的调节机构 12处于"关"的状态， 支撑体 2受到约束， 不能 绕转动轴 51自由转动， 从而通过支撑体 2将软腭向舌根方向托起， 改变了软腭摆 动的中轴线。 软腭的软组织仍然可以在一定范围内摆动， 但摆动被约束在以支 撑体 2为支撑面的两侧， 从而通过托起软腭和部分舌根部， 扩大了咽部的呼吸道， 达到治疗鼾症和 OSAHS的目的。
[53] 图 12是本发明所述的旋转分档式可调节的软腭支撑体处于"开"的状态吋的结构 示意图。 本实施例中调节机构 12釆用旋转开关分档式结构。 转动旋转开关， 使 支撑体 2能在较大范围内运动， 即硬腭连接端 1上的调节机构 12处于"开"的状态， 支撑体 2能绕转动轴 51自由转动， 从而支撑体 2能随软腭的摆动而无约束的摆动
[54] 图 13是本发明所述的旋转分档式可调节的软腭支撑体处于"关"的状态吋的结构 示意图。 本实施例中调节机构 12釆用旋转分档式定位结构。 转动旋转开关， 使 支撑体 2的运动限制在较小的范围， 即硬腭连接端 1上的调节机构 12处于"关"的状 态， 对应于不同的档位， 支撑体 2对软腭的托起程度不同。 由于支撑体 2受到约 束， 不能绕转动轴 51在较大范围内自由转动， 从而通过支撑体 2将软腭向舌根方 向托起， 改变了软腭摆动的中轴线。 软腭的软组织仍然可以在一定范围内摆动 ， 但摆动被约束在以支撑体 2为支撑面的两侧， 从而通过托起软腭和部分舌根部 ， 扩大了咽部的呼吸道，达到治疗鼾症和 OSAHS的目的。
[55] 图 14是本发明所述的双按钮三档式可调节的软腭支撑体处于 "开"的状态吋的结 构示意图。 本实施例中调节机构 12釆用双按钮式三档式结构， 按下靠近门牙方 向的按钮 53吋， 硬腭连接端 1上的调节机构 12处于"开"的状态， 支撑体 2能绕转动 轴 51自由转动， 从而支撑体 2能随软腭的摆动而无约束的摆动。
[56] 图 15是本发明所述的双按钮三档式可调节的软腭支撑体处于 "关"的状态吋的结 构示意图。 本实施例中调节机构 12釆用双按钮三档式开关结构， 按下靠近舌根 方向的按钮 54吋， 硬腭连接端 1上的调节机构 12依次处于不同档位的 "关"状态， 对应于不同的档位， 支撑体 2对软腭的托起程度不同。 由于支撑体 2受到约束， 不能绕转动轴 51自由转动， 从而通过支撑体 2将软腭向舌根方向托起， 改变了软 腭摆动的中轴线。 软腭的软组织仍然可以在一定范围内摆动， 但摆动被约束在 以支撑体 2为支撑面的两侧， 从而通过托起软腭和部分舌根部， 扩大了咽部的呼 吸道，达到治疗鼾症和 OSAHS的目的。
[57] 图 16是本发明所述的直线平移式连续调节的软腭支撑体处于 "开"的状态吋的结 构示意图。 本实施例中调节机构 12釆用滑块式连续定位机构。 向门牙方向直线 推开滑块 59， 使支撑体 2能在较大范围内运动， 即硬腭连接端 1上的调节机构 12 处于"开"的状态， 支撑体 2能绕转动轴 51自由转动， 从而支撑体 2能随软腭的摆动 而无约束的摆动。
[58] 图 17是本发明所述的直线平移式连续调节的软腭支撑体处于 "关"的状态吋的结 构示意图。 本实施例中调节机构 12釆用滑块式连续定位机构。 向舌根方向直线 推开滑块 59， 使支撑体 2的运动限制在较小的范围， 即硬腭连接端 1上的调节机 构 12处于"关"的状态， 对应于不同的档位， 支撑体 2对软腭的托起程度不同。 由 于支撑体 2受到约束， 不能绕转动轴 51在较大范围内自由转动， 从而通过支撑体 2将软腭向舌根方向托起， 改变了软腭摆动的中轴线。 软腭的软组织仍然可以在 一定范围内摆动， 但摆动被约束在以支撑体 2为支撑面的两侧， 从而通过托起软 腭和部分舌根部， 扩大了咽部的呼吸道，达到治疗鼾症和 OSAHS的目的。
[59] 图 18是本发明所述的螺纹连续调节的软腭支撑体处于 "开"的状态吋的结构示意 图。 本实施例中调节机构 12釆用螺纹定位机构。 向外旋转调节螺杆 61， 使支撑 体 2能在较大范围内运动， 即硬腭连接端 1上的调节机构 12处于"开"的状态， 支撑 体 2能绕转动轴 51自由转动， 从而支撑体 2能随软腭的摆动而无约束的摆动。
[60] 图 19是本发明所述的螺纹连续调节的软腭支撑体处于 "关"的状态吋的结构示意 图。 本实施例中调节机构 12釆用螺纹定位机构。 向内旋转调节螺杆 61， 使支撑 体 2的运动限制在较小的范围， 即硬腭连接端 1上的调节机构 12处于"关"的状态， 对应于不同的档位， 支撑体 2对软腭的托起程度不同。 由于支撑体 2受到约束， 不能绕转动轴 51在较大范围内自由转动， 从而通过支撑体 2将软腭向舌根方向托 起， 改变了软腭摆动的中轴线。 软腭的软组织仍然可以在一定范围内摆动， 但 摆动被约束在以支撑体 2为支撑面的两侧， 从而通过托起软腭和部分舌根部， 扩 大了咽部的呼吸道，达到治疗鼾症和 OSAHS的目的。
[61] 图 20是本发明所述的电动调节的软腭支撑体处于"开"的状态吋的结构示意图。
本实施例中调节机构 12釆用电动定位机构。 按下电动调节控制开关 64， 在内置 电源 65的驱动下， 电动装置 63通过传动机构 66使支撑体 2能在较大范围内运动， 即硬腭连接端 1上的调节机构 12处于"开"的状态， 支撑体 2能绕转动轴 51自由转动 ， 从而支撑体 2能随软腭的摆动而无约束的摆动。
[62] 图 21是本发明所述的螺纹连续调节的软腭支撑体处于 "关"的状态吋的结构示意 图。 本实施例中调节机构 12釆用电动定位机构。 按下电动调节控制开关 64， 在 内置电源 65的驱动下， 电动装置 63通过传动机构 66使支撑体 2能在较小范围内运 动， 即硬腭连接端 1上的调节机构 12处于"关"的状态， 支撑体 2将软腭托起。 由于 支撑体 2受到约束， 不能绕转动轴 51在较大范围内自由转动， 从而通过支撑体 2 将软腭向舌根方向托起， 改变了软腭摆动的中轴线。 软腭的软组织仍然可以在 一定范围内摆动， 但摆动被约束在以支撑体 2为支撑面的两侧， 从而通过托起软 腭和部分舌根部， 扩大了咽部的呼吸道，达到治疗鼾症和 OSAHS的目的。
[63] 图 22是本发明所述的电动调节的软腭支撑体处于 "开"的状态吋的结构示意图。
本实施例中与实施例 20基本相同， 不同点在于将内置的电动调节控制开关 64釆 用遥控器 67来替代。
[64] 图 23是本发明所述的螺纹连续调节的软腭支撑体处于 "关"的状态吋的结构示意 图。 本实施例中与实施例 20基本相同， 不同点在于将内置的电动调节控制开关 6 4釆用遥控器 67来替代。
[65] 图 24是本发明所述的可调节的软腭支撑体的结构示意图。 本实施例中连接结构 11是紧固件用通孔 69与卡边 70的组合。 安装吋， 在硬腭 101上开一个与硬腭连接 端 1相吻合的槽孔， 能将调节机构 12的壳体 124置于其中。 将卡边 70卡在硬腭 101 靠鼻腔一侧， 而可用紧固螺钉 116通过紧固件用通孔 69将硬腭连接端 1固定在硬 腭 101上。
[66] 图 25是本发明所述的可调节的软腭支撑体的结构示意图。 本实施例中连接结构 11釆用通孔结构， 用于在硬腭上固定硬腭连接端 1的 3个紧固件用通孔 69在硬腭 连接端 1的底部呈三角形分布， 构成连接结构 11。 可用紧固螺钉 116通过紧固件 用通孔 69将硬腭连接端 1固定在硬腭 101上。
[67] 图 26是本发明所述的凸凹卡配合型组合式可调节的软腭支撑体未组装吋的结构 示意图。
[68] 图 27是本发明所述的凸凹卡配合型组合式可调节的软腭支撑体组装后的结构示 意图。
[69] 图 28是本发明所述的螺纹型组合式可调节的软腭支撑体未组装吋的结构示意图
[70] 图 29是本发明所述的螺纹型组合式可调节的软腭支撑体组装后的结构示意图。
[71] 图 30是本发明所述的可调节的软腭支撑体的结构示意图。 在本实施例中， 支撑 体 2的横截面为弧型， 支撑体 2有较好的刚度。
[72] 图 31是图 30的 A_A剖视图。
[73] 图 32是本发明所述的可调节的软腭支撑体的结构示意图。 在本实施例中， 支撑 体 2的背面有加强筋， 其横截面上有 2个加强筋， 支撑体 2有较好的刚度。
[74] 图 33是图 32的 B_B剖视图。
[75] 图 34是本发明所述的可调节的软腭支撑体的结构示意图。 在本实施例中， 支撑 体 2的横截面瓦楞型， 支撑体 2有较好的刚度。
[76] 图 35是图 34的 B_B剖视图。
[77] 上述图中： 1为硬腭连接端， 2为支撑体， 11为硬腭连接端上设置的将本发明所 述的支撑体固定在硬腭上的连接结构， 12为硬腭连接端上设置的为控制支撑体 的运动状态或弯曲弧度或控制软腭的托起程度的调节机构。 121为开关结构， 12 2为分档调节机构， 123为连续调节机构， 124为调节机构的壳体， 125为调节控 制键， 126为医用柔性材料膜。 20为弹性模块， 21为通孔， 22为凸凹纹或粗糙面 ， 40为刚性模块， 50为推杆， 51为转动轴， 52为复位弹簧， 53为靠近门牙方向 的按钮， 54为靠近舌根方向的按钮， 55为分档定位块， 56为旋转调节开关， 57 为分档调节定位槽， 58为定位块， 59定位滑块， 60为调节杆， 61为调节螺杆， 6 2为导向杆， 63为电动装置， 64为电动调节控制开关， 65为电源， 66为传动机构 ， 67为遥控器， 68为电路， 69为紧固螺钉用通孔， 70为卡边。 101为硬腭， 102为 软聘， K 为鼻咽部， 104为软腭的后端， 105为会厌， 106为食道， 107为气管， 10 8为软腭的前端， 109为支撑骨， 110为鼻腔， 111为口腔， 112为舌头， 113为硬腭一 软腭分界线， 114为舌根， 115为本发明所述的可调节的软腭支撑体， 116为紧固件 本发明的最佳实施方式
[78] 为了方便理解本发明， 现在结合参考图垤图 3来说明 OSAHS的发病机理。
[79] 图 1是经鼻呼吸吋人体头部侧面剖视图。 人在呼吸吋， 软腭 102自然下垂， 会厌 1
05张开， 空气可以通过鼻腔 110或者张开口呼吸吋经口腔 111， 进入气管 107。
[80] 图 2是吞咽吋人体头部侧面剖视图。 人在吞咽吋， 软腭 102向后贴， 封闭鼻咽部
103；
[81] 同吋会厌 105封闭气管 107， 食物经过咽部进入食道 106。
[82] 图 3是 OSAHS患者的发病吋的机理图。 OSAHS患者睡眠发病吋， 上呼吸道软组 织塌
[83] 陷， 阻塞上呼吸道， 造成通气量不足， 甚至窒息。 具体而言， OSAHS发生吋 ， 患者软腭 102向后塌陷导致软腭 102与鼻咽部 103之间的通道狭窄或者封闭了该 通道， 同吋舌根软组织塌陷导致了舌根 114与软腭 102之间的通道狭窄或者封闭 了该通道， 从而导致呼吸吋通气量不足， 或者窒息。 也有部分 OSAHS患者因软 腭 102塌陷直接造成了软腭 102与鼻咽部 103之间的通道狭窄或者封闭了该通道， 同吋还因软腭 102塌陷直接导致了舌根 114与软腭 102之间的通道狭窄或者封闭了 该通道， 从而导致呼吸吋通气量不足， 或者窒息。
[84] 针对这一因软腭部分的松弛塌陷而造成鼾症和 OSAHS的致病原因， 本发明治 疗该疾病的思路是： 设计一种植入体， 一端固定在硬腭上， 一端植入软腭中， 以硬腭支撑点， 将松弛塌陷的软腭和部分舌后根软组织托起。 通过向舌根方向 托起软腭， 改变了软腭自然摆动吋的中轴线， 从而扩大了咽部呼吸吋的气道， 达到治疗鼾症和 OSAHS的目的。 由于非睡眠状况下吞咽动作较频繁， 特别是进 食吋； 而睡眠吋吞咽动作较少， 故本发明中我们公开了一种可调节的软腭支撑 体。
[85] 本发明所述的可调节的软腭支撑体是用可以在人体中长期植入的材料制造的扁 平状植入物， 由硬腭连接端 1和支撑体 2组成。 所述支撑体 2是能插入软腭内的扁 平状植入物； 所述硬腭连接端 1上设有用于将本发明所述的支撑体 115固定在硬 腭上的连接结构 11， 以及控制支撑体 2的运动状态或弯曲弧度或软腭的托起程度 的调节机构 12; 支撑体 2连接在硬腭连接端 1上， 硬腭连接端 1上设置的调节机构 12控制支撑体 2的运动状态或弯曲弧度或软腭的托起程度。
[86] 本发明所述的可调节的软腭支撑体由于硬腭连接端 1固定在硬腭 101上， 支撑体 2植入软腭的肌层中， 以硬腭 101支撑点， 将松弛塌陷的软腭 102和舌后根部的部 分软组织托起。 通过向舌根方向托起软腭， 改变了软腭自然摆动吋的中轴线， 从而扩大了咽部呼吸吋的气道， 达到治疗鼾症和 OSAHS的目的。 非睡眠状况下 吞咽动作较频繁， 特别是进食吋， 可以使可调节的软腭支撑体的调节机构 12处 于"开"的状态， 植入软腭内的支撑体 2能随软腭 102的自然摆动而运动， 减少对吞 咽动作的干扰； 而睡眠状态前， 将可调节的软腭支撑体的调节机构 12处于关的 状态， 植入软腭内的支撑体 2能将软腭托起， 通过向舌根方向托起软腭， 改变了 软腭自然摆动吋的中轴线， 从而扩大了咽部呼吸吋的气道。 从而避免了鼾症和 0 SAHS的发生。 参见图 4。
[87] 进一步， 本发明还设计了分档调节和能连续调节的可调节的软腭支撑体， 这样 通过手指或舌尖或遥控开关来调节植入在硬腭上的控制键 125， 就可以将植入软 腭内的支撑体 2调节在适当位置， 既保持非睡眠状态下吋吞咽的正常， 又能在睡 眠状态下保证能有效托起软腭， 保持睡眠吋上呼吸道的通畅， 避免了鼾症和 OS AHS的发生。
[88] 本发明所述的可调节的软腭支撑体设计精巧， 既可以在局部麻醉下手术， 也可 以在全麻醉下手术。 手术吋， 依据鼾症和 OSAHS严重程度， 选择不同大小的本 发明所述的可调节的软腭支体， 仅需在口腔硬腭处切开一个 2mm〜20mm小切口 ， 将本发明所述的可调节的软腭支撑体的硬腭连接端 1固定在硬腭 101上， 而支 撑体 2插入软腭 102的肌层中， 缝合切口即可完成手术。 实现了微创手术治疗鼾 症和 OSAHS的目的。 临床上， 可用单螺钉固定本发明所述的可调节的软腭支撑 体植入在硬腭和软腭中， 见图 5 ; 也可用双螺钉固定本发明所述的可调节的软腭 支撑体植入在硬腭和软腭中， 见图 6; 还可用三螺钉固定本发明所述的可调节的 软腭支撑体植入在硬腭和软腭中， 见图 7。 釆用本发明的方法和植入的器械， 具 有创伤小， 恢复快， 见效快， 疗效可靠的优点。 特别是手术后患者可以根据自 身的感觉来方便地调节软腭支撑体托起软腭的程度， 以达到最佳治疗效果和舒 适程度。
[89] 实施例 1 : 本发明所述的推杆式可调节的软腭支撑体
[90] 依据本发明所述的技术方案， 选择可在人体中长期植入的医用级钛及医用钛合 金， 按照钛金属制品的通用加工工艺， 制造本发明所述的产品。
[91] 参考图 8至图 9， 本发明所述的推杆式可调节的软腭支撑体的基本结构如下：
[92] 支撑体 2， 釆用厚度为 0.6mm〜lmm的钛金属板， 将钛金属板弯曲， 使之具有 与人体软腭松弛吋的自然弯曲度相匹配的弧度， 并在钛金属板加工微小通孔 21 ， 微小通孔 21直径在 0.5mm〜2mm之间， 方便组织生长渗透。
[93] 硬腭连接端 1 : 釆用钛金属制造硬腭连接端 1。
[94] 连接结构 11 : 在本实施例中， 在硬腭连接端 1上加工可以通过直径是 4mm的螺 钉的通孔， 作为连接结构 11。 通过接结构 11用钛制紧固螺钉 116可以将本发明所 述的可调节的软腭支撑体 115固定在硬腭 101上。
[95] 调节机构 12: 在本实施例中， 本实施例中调节机构 12釆用弹簧推杆式开关结构
。 由推杆 50、 转动轴 51、 复位弹簧 52、 调节杆 60、 定位块 58、 壳体 124、 医用柔 性材料膜 126等构成了调节机构 12。 其中， 推杆 50既与复位弹簧 52、 调节杆 60等 组成了开关结构 121， 又是调节控制键 125。
[96] 非睡眠状态吋， 将推杆 50推向门牙方向， 硬腭连接端 1上的调节机构 12处于"开
"的状态， 支撑体 2能绕转动轴 51自由转动， 从而支撑体 2能随软腭的摆动而无约 束的摆动， 参考图 8。
[97] 睡眠前， 用手指或者舌尖， 将推杆 50推向舌根方向， 硬腭连接端 1上的调节机 构 12处于"关"的状态， 支撑体 2受到约束， 不能绕转动轴 51自由转动， 从而通过 支撑体 2将软腭向舌根方向托起， 改变了软腭摆动的中轴线。 软腭的软组织仍然 可以在一定范围内摆动， 但摆动被约束在以支撑体 2为支撑面的两侧， 从而通过 托起软腭和部分舌根部， 扩大了咽部的呼吸道，达到治疗鼾症和 OSAHS的目的， 参考图 9。
[98] 此外， 可以用于制造支撑体 2的材料包括但不限于： 钛金属、 钛合金、 Nitinol 合金、 医用不锈钢、 其他医用金属材料和医用高分子材料等可以在人体中长期 植入的材料。
[99] 可以用于制造硬腭连接端 1的材料包括但不限于： 钛金属、 钛合金、 Nitinol合 金、 医用不锈钢、 其他医用金属材料和医用高分子材料等可以在人体中长期植 入的材料。
[100] 可以用于制造医用柔性材料膜 126的柔性高分子材料包括但不限于： 医用硅胶
、 医用聚氨脂等可以在人体中长期植入的弹性高分子材料。
[101] 可以用于制造紧固件 116的材料包括但不限于： 钛金属、 钛合金、 Nitinol合金
、 医用不锈钢、 其他医用金属材料和医用高分子材料等可以在人体中长期植入 的材料。
[102] 实施例 2: 本发明所述的双按钮式可调节的软腭支撑体
[103] 依据本发明所述的技术方案， 选择可在人体中长期植入的医用金属材料， 按照 医用金属制品的通用加工工艺， 制造本发明所述的产品。
[104] 参考图 10至图 11， 本发明所述的双按钮式可调节的软腭支撑体的基本结构如下
[105] 支撑体 2， 釆用厚度为 0.6mm〜lmm的钛镍形状记忆合金板， 通过定型热处理 ， 使钛镍形状记忆合金板具有与人体软腭松弛吋的自然弯曲度相匹配的弧度， 并在其表面制造凸凹纹或粗糙面 22， 方便组织生长附着。
[106] 硬腭连接端 1 : 釆用钛金属制造硬腭连接端 1。
[107] 连接结构 11 : 在本实施例中， 在硬腭连接端 1上加工可以通过直径是 4mm的螺 钉的通孔， 作为连接结构 11。 通过连接结构 11用钛制紧固螺钉 116可以将本发明 所述的可调节的软腭支撑体 115固定在硬腭 101上。
[108] 调节机构 12: 在本实施例中， 本实施例中调节机构 12釆用双按钮式开关结构。 由靠近门牙方向的按钮 53， 靠近舌根方向的按钮 54， 分档定位块 55、 转动轴 51 、 复位弹簧 52、 调节杆 60、 定位块 58、 壳体 124、 医用柔性材料膜 126等构成了 调节机构 12。 其中， 靠近门牙方向的按钮 53， 靠近舌根方向的按钮 54， 既与复 位弹簧 52、 调节杆 60、 分档定位块 55等组成了开关结构 121， 又是调节控制键 12
5。
[109] 非睡眠状态吋， 按下靠近门牙方向的按钮 53吋， 硬腭连接端 1上的调节机构 12 处于"开"的状态， 支撑体 2能绕转动轴 51自由转动， 从而支撑体 2能随软腭的摆动 而无约束的摆动， 参考图 10。
[110] 睡眠前， 按下靠近舌根方向的按钮 54吋， 硬腭连接端 1上的调节机构 12处于"关 "的状态， 支撑体 2受到约束， 不能绕转动轴 51自由转动， 从而通过支撑体 2将软 腭向舌根方向托起， 改变了软腭摆动的中轴线。 软腭的软组织仍然可以在一定 范围内摆动， 但摆动被约束在以支撑体 2为支撑面的两侧， 从而通过托起软腭和 部分舌根部， 扩大了咽部的呼吸道，达到治疗鼾症和 OSAHS的目的， 参考图 11。
[111] 实施例 3: 本发明所述的旋转分档式可调节的软腭支撑体
[112] 依据本发明所述的技术方案， 选择可在人体中长期植入的医用金属材料， 按照 医用金属制品的通用加工工艺， 制造本发明所述的产品。
[113] 参考图 10至图 11， 本发明所述的双按钮式可调节的软腭支撑体的基本结构如下
[114] 支撑体 2， 釆用厚度为 0.6mm〜lmm的钛镍形状记忆合金板， 并在金属板加工 微小通孔 21， 微小通孔 21直径在 0.5mm〜2mm之间， 以方便组织生长渗透。 通过 定型热处理， 使钛镍形状记忆合金板具有与人体软腭松弛吋的自然弯曲度相匹 配的弧度。
[115] 硬腭连接端 1 : 釆用钛金属制造硬腭连接端 1。
[116] 连接结构 11 : 在本实施例中， 在硬腭连接端 1上加工可以通过直径是 4mm的螺 钉的通孔， 作为连接结构 11。 通过接结构 11用钛制紧固螺钉 116可以将本发明所 述的可调节的软腭支撑体 115固定在硬腭 101上。
[117] 调节机构 12: 在本实施例中， 本实施例中调节机构 12釆用旋转开关分档式结构 。 由转动旋转调节开关 56、 分档定位块 55、 转动轴 51、 复位弹簧 52、 调节杆 60 、 定位块 58、 壳体 124、 医用柔性材料膜 126等构成了调节机构 12。 其中， 转动 旋转调节开关 56， 既与分档定位块 55、 复位弹簧 52、 调节杆 60等组成了开关结 构 121， 又是调节控制键 125。
[118] 非睡眠状态吋， 转动旋转调节开关 56， 使支撑体 2能在较大范围内运动， 即硬 腭连接端 1上的调节机构 12处于"开"的状态， 支撑体 2能绕转动轴 51自由转动， 从 而支撑体 2能随软腭的摆动而无约束的摆动， 参考图 12。
[119] 睡眠前， 转动旋转调节开关 56， 使支撑体 2的运动限制在较小的范围， 即硬腭 连接端 1上的调节机构 12处于"关"的状态， 对应于不同的档位， 支撑体 2对软腭的 托起程度不同。 由于支撑体 2受到约束， 不能绕转动轴 51在较大范围内自由转动 ， 从而通过支撑体 2将软腭向舌根方向托起， 改变了软腭摆动的中轴线。 软腭的 软组织仍然可以在一定范围内摆动， 但摆动被约束在以支撑体 2为支撑面的两侧 ， 从而通过托起软腭和部分舌根部， 扩大了咽部的呼吸道，达到治疗鼾症和 OSA HS的目的， 参考图 13。
[120] 实施例 4: 本发明所述的双按钮三档式可调节的软腭支撑体
[121] 本实施例中调节机构 12釆用双按钮三档式结构， 其结构基本与实施例 2相同， 其不同点在于：
[122] 第一， 支撑体 2的尾部釆用弹性模块 20与刚性模块 40交替的方式来改善支撑体 2 的尾部的柔顺性。
[123] 第二， 调节机构 12釆用双按钮式三档式结构， 分档调节定位槽 57和分档定位块 55制造在一个部件上， 有三个档位可以调节。 对应于不同的档位， 支撑体 2的运 动范围和托起软腭的程度不一样。
[124] 非睡眠状态吋， 按下靠近门牙方向的按钮 53吋， 硬腭连接端 1上的调节机构 12 处于"开"的状态， 支撑体 2能绕转动轴 51自由转动， 从而支撑体 2能随软腭的摆动 而无约束的摆动， 参考图 14。
[125] 睡眠前， 按下靠近舌根方向的按钮 54吋， 硬腭连接端 1上的调节机构 12依次处 于不同档位的 "关"状态， 对应于不同的档位， 支撑体 2对软腭的托起程度不同。 由于支撑体 2受到约束， 不能绕转动轴 51自由转动， 从而通过支撑体 2将软腭向 舌根方向托起， 改变了软腭摆动的中轴线。 软腭的软组织仍然可以在一定范围 内摆动， 但摆动被约束在以支撑体 2为支撑面的两侧， 从而通过托起软腭和部分 舌根部， 扩大了咽部的呼吸道，达到治疗鼾症和 OSAHS的目的。
[126] 实施例 5: 本发明所述的直线平移式连续调节的软腭支撑体
[127] 本实施例的特点在于： 调节机构 12釆用滑块式连续调节机构 123， 通过滑块 59 的平行移动来连续调节支撑体 2托起软腭的程度。
[128] 此外， 支撑体 2的尾部的弹性模块 20釆用了密排螺旋弹簧结构。
[129] 非睡眠状态吋， 向门牙方向直线推开滑块 59， 使支撑体 2能在较大范围内运动 ， 即硬腭连接端 1上的调节机构 12处于"开"的状态， 支撑体 2能绕转动轴 51自由转 动， 从而支撑体 2能随软腭的摆动而无约束的摆动， 参考图 16。
[130] 睡眠状态吋， 向舌根方向直线推开滑块 59， 使支撑体 2的运动限制在较小的范 围， 即硬腭连接端 1上的调节机构 12处于"关"的状态， 对应于不同的档位， 支撑 体 2对软腭的托起程度不同。 由于支撑体 2受到约束， 不能绕转动轴 51在较大范 围内自由转动， 从而通过支撑体 2将软腭向舌根方向托起， 改变了软腭摆动的中 轴线。 软腭的软组织仍然可以在一定范围内摆动， 但摆动被约束在以支撑体 2为 支撑面的两侧， 从而通过托起软腭和部分舌根部， 扩大了咽部的呼吸道，达到治 疗鼾症和 OSAHS的目的， 参考图 17。
[131] 实施例 6: 本发明所述的螺纹连续调节的软腭支撑体
[132] 本实施例中的不同点在于： 调节机构 12釆用螺纹定位机构， 通过转动调节螺杆 61， 可以方便地控制所述支撑体 2的运动状态或弯曲弧度， 或控制软腭的托起程 度。
[133] 此外， 支撑体 2的尾部的弹性模块 20釆用了医用柔性高分子材料包覆密排螺旋 弹簧结构。
[134] 本实施例的调节机构 12由转动调节螺杆 61、 导向杆 62、 定位滑块 59、 定位块 58 、 转动轴 51、 调节杆 60、 壳体 124、 医用柔性材料膜 126等构成了调节机构 12。 其中， 调节螺杆 61， 既与导向杆 62、 定位滑块 59、 定位块 58调节杆 60等组成了 连续调节机构 123， 又是调节控制键 125， 参考图 18。
[135] 非睡眠状态吋， 向外旋转调节螺杆 61， 使支撑体 2能在较大范围内运动， 即硬 腭连接端 1上的调节机构 12处于"开"的状态， 支撑体 2能绕转动轴 51自由转动， 从 而支撑体 2能随软腭的摆动而无约束的摆动， 参考图 18。
[136] 睡眠前， 向内旋转调节螺杆 61， 使支撑体 2的运动限制在较小的范围， 即硬腭 连接端 1上的调节机构 12处于"关"的状态， 对应于不同的档位， 支撑体 2对软腭的 托起程度不同。 由于支撑体 2受到约束， 不能绕转动轴 51在较大范围内自由转动 ， 从而通过支撑体 2将软腭向舌根方向托起， 改变了软腭摆动的中轴线。 软腭的 软组织仍然可以在一定范围内摆动， 但摆动被约束在以支撑体 2为支撑面的两侧 ， 从而通过托起软腭和部分舌根部， 扩大了咽部的呼吸道，达到治疗鼾症和 OSA HS的目的。 参考图 19。
[137] 实施例 7: 本发明所述的电动调节的软腭支撑体
[138] 本实施例中调节机构 12釆用电动定位机构， 由电源 65、 电路 68、 电动装置 63、 传动机构 66、 电动调节控制开关 64组成， 电源 65、 电路 68、 电动装置 63和传动 机构 66内置在调节机构的壳体 124内。 电动调节控制开关 64设置在壳体 124上， 被医用柔性材料膜 126包覆。
[139] 非睡眠状态吋， 按下电动调节控制开关 64， 在内置电源 65和电路 68的驱动下， 电动装置 63通过传动机构 66使支撑体 2能在较大范围内运动， 即硬腭连接端 1上 的调节机构 12处于"开"的状态， 支撑体 2能绕转动轴 51自由转动， 从而支撑体 2能 随软腭的摆动而无约束的摆动。 参考图 20。
[140] 睡眠前， 按下电动调节控制开关 64， 在内置电源 65和电路 68的控制和驱动下， 电动装置 63通过传动机构 66使支撑体 2能在较小范围内运动， 即硬腭连接端 1上 的调节机构 12处于"关"的状态， 支撑体 2将软腭托起。 由于支撑体 2受到约束， 不 能绕转动轴 51在较大范围内自由转动， 从而通过支撑体 2将软腭向舌根方向托起 ， 改变了软腭摆动的中轴线。 软腭的软组织仍然可以在一定范围内摆动， 但摆 动被约束在以支撑体 2为支撑面的两侧， 从而通过托起软腭和部分舌根部， 扩大 了咽部的呼吸道，达到治疗鼾症和 OSAHS的目的， 参考图 21。
[141] 此外， 本实施例可以改进成为遥控器控制， 电路 68和电动调节控制开关 64按照 无线遥控方式进行改造， 即可以通过遥控器 67来控制， 参考图 22至图 23。
[142] 实施例 8: 本发明所述的组合式可调节的软腭支撑体
[143] 本实施例的不同点在于硬腭连接端 1和支撑体 2在临床上可以分期植入。 [144] 首先， 将硬腭连接端 1通过紧固件 116固定在硬腭 101上。 在硬腭连接端 1植入 3 个月至 6个月后， 硬腭连接端 1与硬腭 101之间固定已经牢固， 再进行一次手术， 将支撑体 2插入软腭 102中， 同吋将支撑体 2的近端与硬腭连接端 1的调节机构 12通 过凸凹卡配合或通过紧固件连接在一起。 这样的好处在于硬腭连接端 1与硬腭 10 1之间的连接牢固， 不好之处在于需要进行两次手术， 增加患者的医疗费用， 参 考图 26至图 29， 图 5至图 7。
[145] 分期植入的组合式本发明所述的支撑体的设计有凸凹卡配合型 （参考图 26至图 27) 或者紧固件连接型 （参考图 28、 图 29) 。
[146] 本发明所述的组合式可调节的软腭支撑体在硬腭连接端 1的调节机构 12上设有 与支撑体 2的近端能形成卡配合的连接结构， 支撑体 2可以方便地固定在硬腭连 接端 1上， 参考图 26至图 27。
[147] 此外， 本发明所述的组合式可调节的软腭支撑体在硬腭连接端 1的调节机构 12 上设有与支撑体 2的近端通过紧固件连接在一起的机构。 釆用的紧固件多为钛螺 钉或铆钉或定位块。 参考图 28、 图 29。
[148] 另外， 为了提高支撑体 2的刚性， 扁平状的支撑体 2的横截面可以是弧形， 或瓦 楞形， 或使用加强筋等增加扁平状物体的刚度的常规方法。
[149] 实施例 9: 本发明所述的支撑体的横截面为弧形的软腭支撑体
[150] 参考图 30， 图 31。 本实施例的不同点在于： 所述支撑体 2的横截面为弧形。 弧 形横截面的支撑体 2优点在于有较好的刚度。 在制造支撑体 2的金属钛板的材料 、 工艺及板的厚度相同的情况下， 支撑体 2釆用弧形横截面比釆用长方形横截面 ， 有更好的刚性。
[151] 此外， 通过提高扁平状物体的刚度的做法有许多种， 如， 在支撑体 2的背面设 置加强筋， 可以提高支撑体 2的刚度， 参考图 32、 图 33; 或者， 将支撑体 2的冲 压成型为瓦楞型或波浪形， 也可以提高支撑体 2的刚度， 参考图 34、 图 35。
[152] 应该注意， 本文中公开和说明的结构可以用其它效果相同的结构代替， 虽然本 发明的优先实施例已在本文中予以介绍和说明， 但本领域内的技术人员都清楚 知道这些实施例不过是举例说明而己， 本领域内的技术人员可以做出无数的变 化、 改进和代替， 而不会脱离本发明的保护范围。

Claims

权利要求书
[Claim 1] 1、 可调节的软腭支撑体， 是用能在人体中长期植入的材料制造的 扁平状植入物， 包括：
支撑体 （2) ， 是能插入软腭内的扁平状植入物； 以及
硬腭连接端 （1) ， 将所述支撑体 （2) 连接到硬腭；
所述硬腭连接端 （1) 包括：
连接结构 （11) ， 设置为使所述硬腭连接端 （1) 固定于硬腭； 调节机构 （12) ， 设置为控制所述支撑体 （2) 的运动状态或弯曲 弧度， 或控制软腭的托起程度。
[Claim 2] 2、 根据权利要求 1所述的可调节的软腭支撑体， 其特征在于： 所 述支撑体 （2) 具有与人体软腭松弛吋的自然弯曲度相匹配的弧度
[Claim 3] 3、 根据权利要求 1所述的可调节的软腭支撑体， 其特征在于： 所 述硬腭连接端 （1) 上的连接结构 （11) 至少包括以下类型的结构
： 孔型结构， U型夹结构， 扣型结构， 铆钉式结构， 以及自膨胀卡 锁结构。
[Claim 4] 4、 根据权利要求 1所述的可调节的软腭支撑体， 其特征在于： 所 述硬腭连接端 （1) 上的调节机构 （12) 是包括开或关两种状态的 开关机构 （121) ； 当调节机构 （12) 在开的状态下， 植入软腭内 的支撑体 （2) 能随软腭的自然摆动而运动； 当调节机构 （12) 在 关的状态下， 植入软腭内的支撑体 （2) 能将软腭托起， 通过向舌 根方向托起软腭， 改变了软腭自然摆动吋的中轴线， 从而扩大了 咽部呼吸吋的气道。
[Claim 5] 5、 根据权利要求 4所述的可调节的软腭支撑体， 其特征在于： 所 述调节机构 （12) 的开关结构 （121) ， 至少包括以下结构： 单键 开关结构， 双键开关结构。
[Claim 6] 6、 根据权利要求 1所述的可调节的软腭支撑体， 其特征在于： 所 述硬腭连接端 （1) 上的调节机构 （12) 是能分档调节支撑体 (2 的运动状态或弯曲弧度或软腭的托起程度的机构。
[Claim 7] 7、 根据权利要求 6所述的可调节的软腭支撑体， 其特征在于所述 硬腭连接端 （1 ) 上的调节机构 （12) 包括一档， 二档或二档以上 的分档调节机构 （122) 。
[Claim 8] 8、 根据权利要求 1所述的可调节的软腭支撑体， 其特征在于： 所 述硬腭连接端 （1 ) 上的调节机构 （12) 是能连续调节支撑体 (2 ) 的运动状态或弯曲弧度或软腭的托起程度的机构。
[Claim 9] 9、 根据权利要求 8所述的可调节的软腭支撑体， 其特征在于： 所 述硬腭连接端 （1 ) 上的调节机构 （12) 包括通过旋转运动或直线 运动来连续调节支撑体 （2) 托起软腭程度的连续调节机构 （123
[Claim 10] 10、 根据权利要求 1所述的可调节的软腭支撑体， 其特征在于， 所 述硬腭连接端 （1 ) 还包括： 壳体 （124) ， 所述调节机构 （12) 安装在壳体 ( 124) 内。
[Claim 1 1] 1 1、 根据权利要求 1所述的可调节的软腭支撑体， 其特征在于， 所 述硬腭连接端 （1 ) 上的调节机构 （12) 包括： 调节控制键 （125
) ， 安装在壳体 （124) 上， 所述调节控制键 （125) 上覆盖能在 人体中植入的柔性高分子材料膜 （126) 。
[Claim 12] 12、 根据权利要求 1 1所述的可调节的软腭支撑体， 其特征在于： 所述壳体 ( 124) 上装有能在人体中植入的柔性高分子材料膜 ( 12 6) ， 所述调节控制键 （125) 上覆盖在所述柔性高分子材料膜 （1 26) 内。
[Claim 13] 13、 根据权利要求 1所述的可调节的软腭支撑体， 其特征在于： 所 述支撑体 （2) 是带孔或不带孔的扁平状物。
[Claim 14] 14、 根据权利要求 1所述的可调节的软腭支撑体， 其特征在于： 所 述支撑体 （2) 是选自至少以下的结构： 横截面为弧性的扁平状物 ， 横截面为瓦楞形的扁平状物， 以及带加强筋的扁平状物。
[Claim 15] 15、 根据权利要求 1所述的可调节的软腭支撑体， 其特征在于： 所 述支撑体 （ 设有至少一个弹性模块 (20) 。
[Claim 16] 16、 根据权利要求 15所述的可调节的软腭支撑体， 其特征在于： 所述弹性模块 (20) 是在外力作用下能变形、 且在外力卸除后又 能恢复变形前的形状的机构或物体。
[Claim 17] 17、 根据权利要求 15所述的可调节的软腭支撑体， 其特征在于： 所述弹性模块 (20) 至少包括以下结构： 弹性高分子材料薄板或 带或膜， 弹簧结构， 被柔性高分子材料包覆的弹簧结构。
[Claim 18] 18、 根据权利要求 1所述的可调节的软腭支撑体， 其特征在于： 所 述支撑体 （ 设有至少一个刚性模块 (40) 。
[Claim 19] 19、 根据权利要求 18所述的可调节的软腭支撑体， 其特征在于： 所述刚性模块 (40) 是有一定支撑力， 但在过度外力作用下能发 生塑性变形、 外力卸除后不能恢复变形前形状的机构或物体。
[Claim 20] 20、 根据权利要求 1所述的可调节的软腭支撑体， 其特征在于： 所 述支撑体 （2) 可组合或装拆地与硬腭连接端 （1) 连接。
[Claim 21] 21、 根据权利要求 1所述的可调节的软腭支撑体， 其特征在于： 所 述支撑体 （2) 插入软腭 （102) 的长度在软腭总长度的 1/5至 4/5之 间， 其最佳插入长度在 2/3至 3/4之间。
PCT/CN2009/074959 2008-11-17 2009-11-16 可调节的软腭支撑体及植入方法 WO2010054603A1 (zh)

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AU2009316097A AU2009316097B2 (en) 2008-11-17 2009-11-16 Adjustable support for soft palate and implanting method thereof
JP2011535863A JP5481487B2 (ja) 2008-11-17 2009-11-16 調整可能な軟口蓋支持体及び移植方法
EP09825778.5A EP2356954B1 (en) 2008-11-17 2009-11-16 Adjustable support for soft palate
CA2747842A CA2747842C (en) 2008-11-17 2009-11-16 Adjustable support for soft palate and implanting method thereof
US13/129,383 US8656921B2 (en) 2008-11-17 2009-11-16 Adjustable Support for Soft Palate and Implanting Method thereof
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CN2008102191690A CN101732108B (zh) 2008-11-17 2008-11-17 高柔顺性软腭支撑体
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CN 200910192688 CN102028559B (zh) 2009-09-27 2009-09-27 可调节的软腭支撑体

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