WO2012174954A1 - 层状结构的软腭支撑体及植入方法 - Google Patents
层状结构的软腭支撑体及植入方法 Download PDFInfo
- Publication number
- WO2012174954A1 WO2012174954A1 PCT/CN2012/075238 CN2012075238W WO2012174954A1 WO 2012174954 A1 WO2012174954 A1 WO 2012174954A1 CN 2012075238 W CN2012075238 W CN 2012075238W WO 2012174954 A1 WO2012174954 A1 WO 2012174954A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- support
- soft palate
- layered structure
- hard
- palate
- Prior art date
Links
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
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/16—Central respiratory analeptics
Definitions
- the present invention relates to a soft palate support of a layered structure, particularly a soft palate support and an implantation method for treating a layered structure of obstructive sleep apnea/hypopnea syndrome (OSAHS) in adults.
- OSAHS obstructive sleep apnea/hypopnea syndrome
- OSAHS Autism obstructive sleep apnea hypopnea syndrome
- OSAHS is a sleep-disordered disorder characterized by snoring and apnea as a result of blockage of upper airway collapse during sleep. Even with the lowest diagnostic criteria, the prevalence of OSAHS is about 4% in adult males and about 2% in females, which is a serious threat to the health of patients.
- OSAHS For the pathogenesis of OSAHS, it is generally believed that the main cause is the soft tissue collapse and obstruction due to the relaxation of the pharyngeal muscle that maintains the upper airway during sleep.
- the obstruction plane is mostly located in the soft palate, tonsil and tongue root.
- Non-surgical treatment methods mainly include:
- CPAP Continuous positive airway pressure
- oral appliance 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 airway is blocked during sleep. There are many types of this method, which have certain effects, but most patients are difficult to adapt.
- the oral appliance has a certain degree of irritability and foreign body sensation, which makes it impossible to sleep. Long-term use can also cause temporomandibular joint damage.
- the main treatment methods for surgical treatment are:
- Radiofrequency ablation also known as low-temperature plasma radiofrequency ablation
- Radiofrequency ablation is a minimally invasive surgical procedure. Mainly to infiltrate the electrode into the soft tissue that causes airway obstruction, such as soft palate, tongue root and other parts, electric heating to make the tissue 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 critically ill patients.
- the soft palate support of the layered structure 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, comprising: a hard-twisted connection end having a connection structure connected to the hard palate;
- the support body is a layered structure formed by stacking two or more layers of support plates that can be inserted into the soft palate; the support body is detachably or non-detachably fixed to the hard palate connection end.
- the length L1 of the hard ⁇ connection end is between 5 and 30 mm, and the length L2 of the support body is between 15 mm and 60 mm; the support angle ⁇ of the support body, that is, the angle between the hard ⁇ plane and the most distal end of the support body , between 30 ° ⁇ 80 °.
- the proximal bending radius R1 of the support body that is, the bending radius R1 near the hard end connecting end is between 10 mm and 100 mm; the distal end bending radius R2 of the supporting body, that is, the bending radius R2 away from the hard end connecting end is 20 mm ⁇ Between 120mm; the thickness of the proximal end of the support is ⁇ at 0.5mn! Between ⁇ 1.8mm, the distal thickness ⁇ 2 is between 0.1mm ⁇ 0.8mm.
- the sweep angle ⁇ of the distal end of the support body, the angle ⁇ between the plane of the distal support plate of the support body and the plane of the tail is between 0° and 75°, preferably 20° to 50°. ° between.
- the support plate is a thin wall plate made of a medical elastic material and having a curvature matching the shape of the soft palate.
- the thickness of the thin wall plate is between 0.01 mm and 1.5 mm, preferably O.Olmn! ⁇ 0.8mm between.
- the wall thickness of the support plate may be equal thickness or non-equal thickness; when the support plate is of non-equal thickness, the longer the length of the support plate is, the larger the swing amplitude is, and the smaller the wall thickness is.
- the superimposed layer M of the thin-walled support plate of the layered structure of the soft palate support at the proximal end (ie, near the hard-twisted joint end) is larger than the soft palate support of the layered structure at the distal end (ie, away from the hard-twisted joint end)
- the order of the support plates of the layered structure is arranged in descending order of length, the front support plate, that is, the support plate near the tooth direction is long; the rear support plate, that is, the support near the rear wall of the pharynx The board is shorter.
- the arrangement order of the support plates of the layered structure is sequentially arranged in an increasing length manner, and the front support plate, that is, the support plate near the tooth direction is shorter; the rear support plate, that is, the support near the rear wall of the pharynx The board is longer.
- the arrangement order of the support plates of the layered structure is a sandwich arrangement, the lengths of the front support plate and the last support plate are close or equal, and the intermediate support plates are arranged in a decreasing manner in a decreasing manner or symmetrically. Arranged in increments.
- the arrangement order of the support plates of the layered structure is a sandwich arrangement
- the front support plate and the last support plate are formed by U-folding the same plate, and the intermediate support plate is reduced in length.
- the modes are arranged in a sequence or in a symmetric manner or in an incremental manner.
- the support plate includes a through hole for facilitating tissue growth coverage, and the support body is fixed in the soft tendon muscle layer.
- the soft palate support of the layered structure contains passivated edges.
- the passivated edge has a variety of designs, primarily - the passivated edge is a helical spring structure that is threaded through the through holes in the edge of the support plate to connect the support plates together.
- the soft-ruthenium support of the layered structure contains a passivated edge, and the passivated edge contains one or more spiral spring segments which are wound in the through holes of the support plate to connect the support plates together.
- the passivated edge is a rivet type structure or a bump card engaging structure.
- the soft palate support of the layered structure comprises a limiting mechanism for limiting the distance between each support layer and the layer of the support of the layered structure, and the bending curvature of the support plate can occur under the constraint of the limiting mechanism
- the change, but the gap of the support plates of each layer is limited by the limiting mechanism, and the gap is less than 2 mm.
- the limit mechanism can be designed in a variety of ways, the main ones of which are:
- the limiting mechanism is a limiting pin of the concave-convex card fitting structure, and is composed of a locking cap and a pin.
- the limiting mechanism is composed of a limiting slot and a limiting plate.
- the limiting plate is a part of the edge of one of the supporting plates. After bending, a rectangular or U-shaped slot is formed as a limiting slot.
- the soft palate support of the layered structure contains an adjustment mechanism capable of adjusting the curvature of the support plate.
- the adjustment mechanism has a variety of design options, mainly:
- the adjustment mechanism is a wedge adjustment mechanism.
- the curvature of the support body can be changed by adjusting the wedge adjustment mechanism; the movement of the wedge adjustment mechanism to the proximal end increases the degree of bending of the support body, thereby increasing the degree of lifting of the soft palate; and moving the wedge adjustment mechanism to the distal end reduces The degree of bending of the support, thereby reducing the degree of lifting of the soft palate.
- the adjustment mechanism is an adjustment washer. Increasing the height of the adjusting spacer increases the degree of bending of the supporting body, thereby increasing the degree of lifting of the soft palate; while lowering the height of the adjusting shim reduces the degree of bending of the supporting body, thereby reducing the degree of lifting of the soft palate.
- the medical elastic material for manufacturing the support plate is selected from the group consisting of amorphous alloys (or metallic glasses), titanium zirconium lanthanum alloys, titanium nickel shape memory alloys, titanium and titanium alloys, medical stainless steels, and medical elastic non-metallic materials.
- the amorphous alloy is an amorphous alloy having excellent elasticity and excellent fatigue resistance, and is selected from the group consisting of titanium-based amorphous metal materials, zirconium-based amorphous metal materials, and bismuth-based amorphous metals. Material, iron-based amorphous metal material.
- connection structure of the hard ⁇ connection end is a through hole in which the hard ⁇ connection end can be fixed to the hard boring with a screw.
- the connection structure of the hard ⁇ connection end generally adopts a through hole structure, and the hard ⁇ connection end can be fixed to the hard boring with a screw through the through hole.
- the hard cymbal connection end includes a fixing rivet
- the support plates at the hard ⁇ connection end are riveted together to facilitate the installation of the product.
- the soft palate support of the layered structure of the present invention is implanted by cutting a small incision at the junction of the soft palate and the hard palate, and then inserting the support into the muscular layer of the middle part of the soft palate; then passing the medical bone nail through A through hole on the hard end of the connector, the hard end is fixed to the hard crotch.
- 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 optimum insertion length is between 2/3 and 3/4.
- the implantation of the soft palate support of the layered structure can be divided into two stages of implantation, and the first stage is first implanted with the hard palate connection end of the soft palate support of the layer structure, and the bone nail is passed through the connection of the hard palate connection end.
- the hole, the mi ⁇ connection end is fixed on the hard palate; after 1 month to 3 months, the hard palate connection is firmly fixed on the hard palate, then the 2nd operation is performed, and a small incision is made at the junction of the soft palate and the hard palate, and then One end of the support body is inserted into the muscle layer of the middle part of the soft palate; the other end of the support body is fixed on the hard palate connection end.
- the present invention relates to a soft palate support for a layered structure for treating sleep apnea syndrome or snoring, which is a flat plant made of a material that can be implanted in a human body for a long period of time.
- the inclusion body has a hard-twisted connection end and a support body, and the support body is a layered structure formed by superposing 2 or more layers of support plates which can be inserted into the soft palate, and the support body is detachably or non-detachably fixed to the hard palate.
- connection end a connection structure connected to the hard raft is provided on the hard ⁇ connection; the hard ⁇ connection end is fixed on the hard raft through the connection structure, and the support body is implanted in the muscular layer of the soft palate, and the length of the insertion soft palate is 1 in the total length of the soft palate Between /5 and 4/5.
- the support force is ensured, not only the compliance of the support body is improved, but also the fatigue fracture resistance of the support body is greatly improved.
- the soft palate support of the layered structure can effectively hold up the soft palate that collapses during sleep, the upper airway obstruction can be improved, thereby achieving the purpose of treating OSAHS and snoring.
- the clinical application proves that the method and the implanted device of the invention have the advantages of less trauma, less complications, reliable treatment and good comfort, and achieve the purpose of minimally invasive treatment.
- the soft palate support in which the layered structure of the present invention is implanted when clinically implanted, adjusts the curvature of the support body by adjusting the position of the wedge adjustment mechanism as needed, or adjusts the support by adjusting the height of the spacer.
- the degree of curvature of the body is achieved by adjusting the degree of lifting of the soft palate support within a certain range to achieve the best therapeutic effect and comfort.
- FIG. 1 is a soft palate support of a layered structure arranged in a decreasing manner according to the present invention, which is fixed on a hard palate Schematic diagram of the structure.
- Fig. 2 is a schematic view showing the structure of the soft palate support of the layered structure arranged in an incremental manner according to the present invention.
- Fig. 3 is a structural schematic view showing the soft palate support of the layered structure arranged in a symmetrical manner according to the present invention fixed on a hard palate.
- Fig. 4 is a structural schematic view showing the soft palate support of the layered structure in which the sandwich is arranged in a reduced manner on the hard palate.
- Fig. 5 is a structural schematic view showing the soft palate support of the layered structure of the sandwich symmetrically arranged on the hard palate.
- Fig. 6 is a structural schematic view showing the soft palate support of the layered structure in which the sandwich is arranged in an incremental manner, which is fixed on the hard palate.
- Fig. 7 is a view showing the structure of a soft palate support of a layered structure of an isometric layer according to the present invention.
- Fig. 8 is a schematic view showing the structure of a soft palate support of two equal-length layered structures according to the present invention.
- Fig. 9 is a perspective view showing the structure of a soft palate support of a layered structure in which U-shaped sandwiches are gradually arranged in accordance with the present invention.
- Figure 9-1 is a side view of Figure 9.
- Fig. 10 is a perspective view showing the structure of the soft palate support of the layered structure of the present invention comprising a spiral wound edge of a monofilament wound.
- Fig. 11 is a schematic view showing the structure of a soft palate support of the layered structure of the present invention having a passivated edge which is a coil spring section.
- Fig. 12 is a perspective view showing the structure of the soft palate support of the layered structure of the present invention in which the passivated edge is a concave-convex card-fitted structure.
- Figure 12-1 is a front view of Figure 12.
- Figure 12-2 is a side view of Figure 12.
- Figure 12-3 is a rear view of Figure 12.
- Figure 12-4 is a cross-sectional view taken along line A-A of Figure 12 .
- Figure 12-5 is an enlarged view of Area C of Figure 12-4.
- Figure 12-6 is a cross-sectional view of the edge of the embossed card mating structure of Figure 12-4 taken along line B-B.
- Fig. 13 is a schematic view showing the structure of a soft palate support of the layered structure according to the present invention including a stopper mechanism.
- Figure 13-1 is a schematic view of the structure of the rivet type limit mechanism.
- Figure 13-2 is a schematic view of the structure of the embossed card-fitted limit mechanism.
- Fig. 14 is a perspective view showing the structure of a soft palate support of the layered structure of the present invention comprising a U-shaped groove type stopper mechanism.
- FIG. 14-1. 14 is a front view of FIG.
- Figure 14-2 is a side view of Figure 14.
- Figure 14-3 is a rear view of Figure 14.
- FIG. 14-4 is a schematic diagram of Alice at the end 14 of FIG.
- Figure 15 is a schematic view showing the structure of a soft palate support of the detachable layered structure of the present invention including an adjustment pad.
- Figure 15-1 is a front view of Figure 15.
- Figure 16 is a schematic view showing the structure of a detachable layered structure soft palate support according to the present invention including a wedge-shaped adjustment mechanism.
- Figure 16-1 is a front view of Figure 16.
- Fig. 17 is a schematic view showing the structure of the soft palate support of the present invention which can be implanted in stages.
- Figure 17-1 is an exploded view of Figure 17.
- Figure 17-2 is a structural schematic view of the first stage surgically mounted hard palate connection of Figure 17.
- Figure 17-3 is a schematic view showing the structure of the second-stage surgical mounting support of Figure 17.
- 1 is a hard-twisted joint
- 2 is a support
- 3 is a layered soft palate support according to the present invention
- 5 is a bone nail
- 6 is a hard palate
- 7 is a soft palate
- 8 is a screw.
- 11 is a connection structure connected to the hard raft on the hard ⁇ connection end
- 111 is a connection through hole.
- 21 is the support plate
- 211 is the tail of the support plate.
- 22 is the through hole on the support plate.
- 23 is the passivation edge of the support plate
- 231 is a spring section
- 232 is a concave and convex card to match the edge of the garden.
- 24 is a limit mechanism
- 241 is a lock cap
- 242 is a lock pin
- 243 is a limit plate
- 244 is a limit groove
- 25 is an adjustment mechanism
- 251 is a wedge adjustment mechanism
- 252 is an adjustment washer
- 26 is a fixed rivet.
- ⁇ is the support angle of the support
- the support ⁇ is the sweep angle of the distal end of the support.
- L1 is the length of the hard-twisted end, the length of the L2 support (2)
- ⁇ is the thickness of the proximal end of the support
- ⁇ 2 is the thickness of the distal end of the support.
- R1 is the proximal bending radius of the support
- R2 is the distal bending radius of the support.
- ⁇ is the superimposed layer of the soft palate support at the proximal support plate, and ⁇ is the superimposed layer of the soft palate support at the distal support plate.
- P1 is the first isometric layer of the layered structure of the support from the front to the back; ⁇ 2 is the second layer of the support from the front to the back.
- the principle of the treatment of the OSAHS of the present invention is: supporting the collapsed soft palate 7 by inserting the support 2 in the soft diaphragm layer with the support of the hard palate 6, for the purpose of treating OSAHS, refer to Fig. 15 to Fig. 15-3.
- the present invention is directed to how to improve the fatigue resistance of the soft palate support 2, and discloses a technical solution for improving the fatigue life of the soft palate support body, that is, a support plate having a layered structure formed by laminating thin wall plates is used as the support body 2, While ensuring the supporting force, it not only improves the compliance of the support, but also greatly improves the ability of the support to resist fatigue fracture.
- the fatigue life is about 3 ⁇ 10 6 times, and the fatigue life is about 5 years according to the swallowing action once per minute. .
- a titanium-based amorphous metal material having a thickness of 0.1 mm is also called titanium-based metallic glass
- the fatigue life is more than 8 times in lxlO, and the fatigue life is about 190 years.
- the soft palate support of the layered structure formed by the lamination of the thin-walled panels can fully meet the clinical needs.
- Embodiment 1 The soft palate support of the layered structure arranged in a decreasing manner according to the present invention
- this embodiment shows a soft palate support of a layered structure arranged in a decreasing manner according to the present invention.
- the support plate 21 defining the direction of the tooth is the front support plate 21, the support plate 21 near the rear wall of the pharynx is the rear support plate 21, and the support plate 21 having the same length is the isometric support plate 21.
- the support body 2 contains a total of five equal length support plates of P1, P2, P3, P4, and P5. 21, wherein the PI layer and the P2 layer are each composed of two support plates 21.
- Each of the thin-walled support plates 21 of the P1 layer and the P2 layer has a thickness of 0.1 mm, and the thickness of the thin-walled support plates 21 of the respective layers P3, P4, and P5 is 0.2 mm.
- the total thickness ⁇ ⁇ of the support 2 is 1 mm; at the distal end, the thickness ⁇ 2 of the support 2 is 0.2 mm.
- the length L2 of the support 2 is 30 mm.
- the foremost support plate 21 is the longest, the last support plate 21 is the shortest, the length of the support plate 21 is gradually reduced from front to back, and the length of each layer of support plates 21 is P1 > P2 > P3 > P4 > P5, forming a length
- the descending arrangement is sequentially superimposed to form a soft structure support 2 of a layered structure.
- the layered soft palate support 3 of the present invention has different geometries and sizes depending on the condition of the specific patient.
- the length L1 of the hard-twisted end 1 is 5 ⁇ Between 30mm, the length L2 of the support body 2 is between 15mm and 60mm; the support angle ⁇ of the support body 2, that is, the angle between the hard palate plane and the most distal end of the support body 2, is between 30° and 80°.
- the proximal end bending radius R1 of the support body 2, that is, the bending radius R1 near the hard crotch connection end 1 is between 10 mm and 100 mm; the distal end bending radius R2 of the support body 2, that is, the bending radius R2 away from the hard crotch connection end 1 Between 20mm and 120mm; the sweep angle ⁇ of the distal tail 211 of the support body 2, the angle ⁇ between the plane of the distal support plate 21 of the support body 2 and the plane of the tail 211 is between 0° and 75°.
- the preferred value is between 20° and 50°;
- the proximal end thickness ⁇ of the support body 2 is between 0.5 mm and 1.8 mm, and the distal end thickness ⁇ 2 is between 0.1 mm and 0.8 mm.
- the support plate 21 is made of a medical elastic material and is a thin wall plate having a curvature matching the shape of the soft palate.
- the thickness of the thin wall plate is between 0.01 mm and 1.5 mm, preferably between 0.01 mm and 0.8 mm.
- the medical elastic material for manufacturing the support plate 21 is selected from the group consisting of: amorphous alloy or metal glass, titanium zirconium lanthanum alloy, titanium nickel shape memory alloy, titanium and titanium alloy, medical stainless steel, medical elastic nonmetal material and the like.
- the most commonly used materials are titanium-nickel shape memory alloys or amorphous alloys, also known as metallic glass. Both of these materials have excellent elasticity and excellent fatigue resistance, and metallic glass has superior fatigue resistance.
- the amorphous alloy is mainly selected from the group consisting of titanium-based amorphous metal materials, zirconium-based amorphous metal materials, bismuth-based amorphous metal materials, and iron-based amorphous metal materials.
- Titanium-based amorphous metal material is a material body 2 is supported more preferably for producing soft palate fatigue life more than 8 times in lx lO.
- a through hole 22 is provided in the support plate 21, and the through hole 22 can conveniently grow and cover the tissue, and the support plate 21 is effectively fixed in the muscular layer of the soft palate, as shown in Fig. 14-1.
- a fixing rivet 26 may be provided to rive the support plate 21 together. It is clinically installed and fixed, refer to Figure 9 and Figure 9-1.
- a small incision is made at the junction of the soft palate 7 and the hard palate 6, and then the support 2 is inserted into the muscle layer of the middle portion of the soft palate 7; then the medical bone nail 5 is passed through the through hole 111 on the hard palate connection end 1 , Fix the hard end connection 1 to the hard cymbal 6.
- the length of the support 2 inserted 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 support plate of the layered structure formed by the lamination of the thin-walled plates is used as the support body 2, the support force is ensured, not only the compliance of the support body is improved, but also the fatigue fracture resistance of the support body is greatly improved. , its fatigue life is more than 8 times lx lO. Under the same material and treatment process, the smaller the thickness of the support plate 21 constituting the support 2, the higher the fatigue life.
- Embodiment 2 The soft palate support of the layered structure arranged in an incremental manner according to the present invention
- the difference between this embodiment and the embodiment is that the superposition manner of the support plate 21 constituting the support body 2 is changed. From the front to the rear, the length of the support plate 21 is gradually increased, that is, P1 ⁇ P2 ⁇ P3 ⁇ P4 ⁇ P5, forming an incremental arrangement of lengths. Another difference is that the thickness of the support plate 21 is the same. Further, there are many types of superposition of the support plates 21 constituting the support body 2.
- Figure 3 shows a soft-web support of a layered structure arranged in a symmetrical manner.
- the length of the P1 layer is equal to the length of the P5 layer
- the length of the P2 layer is equal to the length of the P4 layer
- the P3 layer is the longest.
- a symmetric arrangement centered on the P3 layer is formed.
- Figure 4 shows a soft-ruthenium support of a layered structure with a decreasing core arrangement.
- the length of the P1 layer is equal to the length of the P5 layer, and the middle three layers, P2 > P3 > P4, constitute a descending arrangement.
- Figure 5 shows a soft-ruthenium support with a layered symmetrically arranged layered structure.
- the length of the P1 layer is equal to the length of the P5 layer, and the middle 3 layers, the length of the P2 layer is equal to the P4 layer, and the P3 layer.
- a symmetric arrangement is formed for the center.
- Fig. 6 shows a soft palate support of a layered structure in which the sandwiches are arranged in an incremental manner.
- the length of the P1 layer is equal to the length of the P5 layer, and the middle 3 layers, P2 ⁇ P3 ⁇ P4, constitute an incremental arrangement.
- the layered structure constituting the support 2 may be one equal length layer, or two equal length layers, or three equal length layers, or four equal length layers, and the like. Each equal length layer can be supported by one or more thin walls The board 21 is superposed.
- Figure 7 shows a layered soft palate support of the present invention in the form of an equal length layer.
- five thin-walled support plates 21 of the same length are superposed to form a support 2, each thin The wall support plate 21 has a thickness of about 0.12 mm.
- Figure 8 shows two layers of the soft-web support of the layered structure of the present invention in the form of two equal-length layers.
- the P1 layer consists of three thin-walled support plates 21 of the same length, and the P2 layer consists of four pieces.
- the thin-walled support plates 21 of the same length; the P1 layer and the P2 layer are superposed to form the support body 2, and each of the thin-walled support plates 21 has a thickness of about 0.08 mm.
- Embodiment 3 The U-shaped sandwich-deposited layered soft palate support of the present invention
- the P1 layer of the frontmost support plate 21 and the last support plate 21P5 layer are made of the same thin-walled metal plate and formed by U-folding;
- the support plates 21 of the P2, P3, and P4 layers are sequentially arranged in a decreasing manner.
- the advantage of this design is that the swing of the support plate 21 is limited between the foremost P1 layer and the last P5 layer, and the support force of the support body 2 can be improved without lowering the compliance.
- Example 4 The soft palate support of the layered structure of the present invention with a coil spring passivated edge
- the support body 2 includes a passivation edge 23, and the passivation edge 23 is a coil spring wound by a single wire.
- the coil spring passes through the through hole 22 at the edge of the support plate 21, and the layers are
- the support plates 21 are connected together to prevent excessive separation of the support plates 21 of the support layers during the swinging process on the one hand, and to passivate the edges of the support body 2 on the other hand to facilitate tissue fixation and growth.
- the coil spring passivation edge 23 is movably passed through the through hole 22 at the edge of the support plate 21 to keep the gap of each layer support plate 21 within a reasonable range, usually less than 0.6 mm.
- Figure 11 shows a segmented winding method in which the various layers of support plates 21 are joined together at different positions by a plurality of sections of metal wires.
- a medical wire can be used, and the wire is selected from the group consisting of: a medical stainless steel wire, a medical titanium wire, a medical titanium nickel shape memory alloy, a medical amorphous alloy wire, and the like, and can also be used.
- the passivation edge 23 of the coil spring structure is fabricated using various medical high strength polymer material filaments or films.
- Embodiment 5 The soft palate support of the layered structure of the present invention in which the passivation edge is the edge of the convex card mating structure.
- the passivation edge 23 on the support body 2 It is a small edge of the convex card engaging structure, and the edge 232 of the small convex card matching structure is intermittently distributed and fixed to On the edge of the support 2, the support layers 21 of the respective layers are joined together.
- Embodiment 6 Soft palate support of layered structure according to the present invention comprising a limiting mechanism
- the support body 2 includes a stopper mechanism 24.
- the setting of the stopper mechanism 24 is to prevent the support body 2 from being excessively separated between the support plates 21 of the layers during the swinging process, i.e., to control the gap between the support plates 21 of the respective layers.
- the simplest and most effective is to use a rivet type limiting structure, that is, rivets are fixed between the support plates 21 of each layer, refer to Figure 13-1.
- the purpose of controlling the gap between the support plates 21 of each layer can also be achieved by the embossing card-fitted limiting structure.
- Embodiment 7 Soft palate support of the layered structure of the present invention comprising a U-shaped groove type stopper structure
- the support body 2 is provided with a limiting mechanism 24, and the limiting mechanism 24 is composed of a limiting slot 244 and a limiting plate 243, and the limiting plate 243 is one of the supporting plates. A portion of the edge of the 21 is bent to form a rectangular or U-shaped slot as the limiting slot 244.
- Example 8 Removable layered structure soft palate support of the present invention comprising an adjustment pad
- a detachable layered structure soft raft support body including an adjustment pad is shown, and the hard ⁇ connection end 1 and the support body 2 are detachably When assembled together, the bone nail 5 is removed, and the support body 2 can be separated from the hard-wired end 1; the bone nail 5 can be tightened, and the support body 2 can be fixed to the hard-wire joint end 1 and fixed together on the hard raft 6.
- an adjusting washer 252 is further provided, the distal end nail 5 is appropriately loosened, the height of the adjusting washer 252 is increased, the lifting angle ⁇ of the supporting body 2 is increased, and the degree of lifting of the soft palate 7 is increased;
- the distal nail 5 is tightened, the height of the adjusting spacer 252 is reduced, the lifting angle ⁇ of the supporting body 2 is decreased, and the degree of lifting of the soft palate 7 is reduced; the degree of lifting of the soft palate 7 by the supporting body 2 can be adjusted within a certain range. It is convenient for clinical installation.
- Embodiment 9 The detachable layered structure soft raft support of the present invention comprising a wedge adjustment mechanism
- a detachable layered structure soft palate support of the present invention including a wedge adjustment mechanism is shown.
- the hard connecting end 1 and the supporting body 2 are detachably assembled together, and the bone nail 5 is removed, and the supporting body 2 can be separated from the hard connecting end 1; the bone nail 5 can be tightened, and the supporting body 2 can be fixed on the hard connecting end 1 , fixed together on the hard cymbal 6.
- a wedge adjustment mechanism 251 is further provided, the distal bone nail 5 is appropriately loosened, the wedge adjustment mechanism 251 is pushed to the proximal end, the lifting angle ⁇ of the support body 2 is increased, and the degree of lifting of the soft palate 7 is increased. Increase; properly tighten the distal bone nail 5, push the wedge adjustment mechanism 251 to the distal end, and reduce the lifting angle ⁇ of the support body 2, The degree of lifting of the soft palate 7 is reduced; the degree of lifting of the soft palate 7 by the support body 2 can be adjusted within a certain range to facilitate clinical installation.
- adjustment mechanism 25 has a variety of designs, and is merely illustrative here.
- Embodiment 10 Soft raft support of the detachable layered structure of the present invention comprising a wedge-shaped adjustment mechanism Referring to Figs. 17 to 17-3, in the present embodiment, a stage implantable by the present invention is shown The soft palate support described.
- the hard splicing end 1 can be fixed to the hard cymbal 6 by a nail 5 which is detachably fitted to the hard splicing end 1 by means of a screw 8.
- Stage 1 surgery Under local anesthesia or full body anesthesia, first make a small incision in the appropriate part of the hard palate 6, then implant the hard palate connection 1 of the soft palate support of the layered structure, and connect the bone nail 5 through the hard palate.
- the through hole 111 on the end 1 fixes the hard crotch connection end 1 to the hard crotch 6 and sutures the slit.
- Stage 2 Surgery After the first stage of surgery is completed, after 1 to 3 months, the hard palate connection 1 is firmly fixed on the hard palate 6, and the second stage operation is performed. Under local anesthesia or whole body anesthesia, cut a small incision at the junction of soft palate 7 and hard palate 6, and then insert one end of the support 2 into the muscle layer of the middle part of the soft palate 7, which is inserted into the soft palate in the length of the soft palate. Between 1/5 and 4/5; the other end of the support body 2 is fixed to the hard joint connection end 1 with a screw 8, and the slit can be sewn. Refer to Figure 17-3.
Abstract
Description
Claims
Priority Applications (8)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US14/000,598 US9445935B2 (en) | 2011-06-22 | 2012-05-09 | Layered soft palate support and implantation method |
EP12803487.3A EP2724689B1 (en) | 2011-06-22 | 2012-05-09 | Soft palate support having a layered structure |
CA2837810A CA2837810C (en) | 2011-06-22 | 2012-05-09 | Soft palate support having layered structure and implanting method |
KR1020147001635A KR101929197B1 (ko) | 2011-06-22 | 2012-05-09 | 층상 구조의 연구개 지지물 및 이식방법 |
AU2012272407A AU2012272407C1 (en) | 2011-06-22 | 2012-05-09 | Soft palate support having layered structure and implanting method |
JP2014516174A JP6157458B2 (ja) | 2011-06-22 | 2012-05-09 | 層状構造の軟口蓋支持体および移植方法 |
SG2013087127A SG195150A1 (en) | 2011-06-22 | 2012-05-09 | Soft palate support having layered structure and implanting method |
US15/236,104 US10369040B2 (en) | 2011-06-22 | 2016-08-12 | Layered soft palate support and implantation method |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201110169918.5 | 2011-06-22 | ||
CN201110169918.5A CN102836017B (zh) | 2011-06-22 | 2011-06-22 | 层状结构的软腭支撑体及植入方法 |
Related Child Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/000,598 A-371-Of-International US9445935B2 (en) | 2011-06-22 | 2012-05-09 | Layered soft palate support and implantation method |
US15/236,104 Continuation US10369040B2 (en) | 2011-06-22 | 2016-08-12 | Layered soft palate support and implantation method |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2012174954A1 true WO2012174954A1 (zh) | 2012-12-27 |
Family
ID=47363928
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/CN2012/075238 WO2012174954A1 (zh) | 2011-06-22 | 2012-05-09 | 层状结构的软腭支撑体及植入方法 |
Country Status (10)
Country | Link |
---|---|
US (2) | US9445935B2 (zh) |
EP (1) | EP2724689B1 (zh) |
JP (1) | JP6157458B2 (zh) |
KR (1) | KR101929197B1 (zh) |
CN (1) | CN102836017B (zh) |
AU (1) | AU2012272407C1 (zh) |
CA (1) | CA2837810C (zh) |
MY (1) | MY167553A (zh) |
SG (1) | SG195150A1 (zh) |
WO (1) | WO2012174954A1 (zh) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102836017B (zh) * | 2011-06-22 | 2017-08-11 | 张湘民 | 层状结构的软腭支撑体及植入方法 |
FR3058313A1 (fr) * | 2016-11-07 | 2018-05-11 | Christophe Bou | Obturateur velaire/ velo-palatin a membrane souple amovible |
CN109009644A (zh) * | 2018-06-29 | 2018-12-18 | 小牛科技河北有限公司 | 用于止鼾的鼻咽支架 |
CN112022466B (zh) * | 2020-09-15 | 2022-10-18 | 中国康复研究中心 | 一种压膜式升腭赝复体及其制造方法 |
WO2023219648A1 (en) | 2022-05-09 | 2023-11-16 | Lockheed Martin Energy, Llc | Flow battery with a dynamic fluidic network |
Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1720881A (zh) * | 2001-03-21 | 2006-01-18 | 康复医疗公司 | 一种治疗患者打鼾的编织的软腭植入物 |
US20080046022A1 (en) * | 2006-02-16 | 2008-02-21 | Pavad Medical, Inc. | Self Charging Airway Implants and Methods of Making and Using the Same |
WO2008097890A2 (en) * | 2007-02-02 | 2008-08-14 | Thomas Jefferson University | Method and use of a bioreplaceable tissue material implant for treating snoring |
CN201320227Y (zh) * | 2008-08-29 | 2009-10-07 | 张湘民 | 植入式软腭支撑体及植入方法 |
US20100037901A1 (en) * | 2008-08-14 | 2010-02-18 | Rousseau Robert A | Methods and devices for treatment of obstructive sleep apnea |
CN101732108A (zh) * | 2008-11-17 | 2010-06-16 | 张湘民 | 高柔顺性软腭支撑体及植入方法 |
WO2010068251A1 (en) * | 2008-12-09 | 2010-06-17 | H-Medical | Apparatus, systems, and methods for constraining and/or supporting tissue structures along an airway |
CN102028559A (zh) * | 2009-09-27 | 2011-04-27 | 张湘民 | 可调节的软腭支撑体及植入方法 |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20090078275A1 (en) * | 2004-09-21 | 2009-03-26 | Pavad Medical, Inc. | Palatal Implant Fixation Devices and Methods |
US7909037B2 (en) | 2006-04-20 | 2011-03-22 | Pavad Medical | Tethered airway implants and methods of using the same |
JP5543971B2 (ja) * | 2008-08-29 | 2014-07-09 | ツァン,シャンミン | 移植式軟口蓋支持体 |
CA2747842C (en) * | 2008-11-17 | 2017-03-07 | Xiangmin Zhang | Adjustable support for soft palate and implanting method thereof |
ATE551035T1 (de) * | 2008-12-30 | 2012-04-15 | Medartis Ag | Implantat zur behandlung des obstruktiven schlafapnoesyndroms |
US8307831B2 (en) * | 2009-03-16 | 2012-11-13 | Ethicon, Inc. | Implant systems and methods for treating obstructive sleep apnea |
CN102836017B (zh) | 2011-06-22 | 2017-08-11 | 张湘民 | 层状结构的软腭支撑体及植入方法 |
-
2011
- 2011-06-22 CN CN201110169918.5A patent/CN102836017B/zh active Active
-
2012
- 2012-05-09 CA CA2837810A patent/CA2837810C/en not_active Expired - Fee Related
- 2012-05-09 EP EP12803487.3A patent/EP2724689B1/en not_active Expired - Fee Related
- 2012-05-09 MY MYPI2013004597A patent/MY167553A/en unknown
- 2012-05-09 JP JP2014516174A patent/JP6157458B2/ja not_active Expired - Fee Related
- 2012-05-09 KR KR1020147001635A patent/KR101929197B1/ko active IP Right Grant
- 2012-05-09 SG SG2013087127A patent/SG195150A1/en unknown
- 2012-05-09 US US14/000,598 patent/US9445935B2/en active Active
- 2012-05-09 AU AU2012272407A patent/AU2012272407C1/en not_active Ceased
- 2012-05-09 WO PCT/CN2012/075238 patent/WO2012174954A1/zh active Application Filing
-
2016
- 2016-08-12 US US15/236,104 patent/US10369040B2/en not_active Expired - Fee Related
Patent Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1720881A (zh) * | 2001-03-21 | 2006-01-18 | 康复医疗公司 | 一种治疗患者打鼾的编织的软腭植入物 |
US20080046022A1 (en) * | 2006-02-16 | 2008-02-21 | Pavad Medical, Inc. | Self Charging Airway Implants and Methods of Making and Using the Same |
WO2008097890A2 (en) * | 2007-02-02 | 2008-08-14 | Thomas Jefferson University | Method and use of a bioreplaceable tissue material implant for treating snoring |
US20100037901A1 (en) * | 2008-08-14 | 2010-02-18 | Rousseau Robert A | Methods and devices for treatment of obstructive sleep apnea |
CN201320227Y (zh) * | 2008-08-29 | 2009-10-07 | 张湘民 | 植入式软腭支撑体及植入方法 |
CN101732108A (zh) * | 2008-11-17 | 2010-06-16 | 张湘民 | 高柔顺性软腭支撑体及植入方法 |
WO2010068251A1 (en) * | 2008-12-09 | 2010-06-17 | H-Medical | Apparatus, systems, and methods for constraining and/or supporting tissue structures along an airway |
CN102028559A (zh) * | 2009-09-27 | 2011-04-27 | 张湘民 | 可调节的软腭支撑体及植入方法 |
Non-Patent Citations (1)
Title |
---|
See also references of EP2724689A4 * |
Also Published As
Publication number | Publication date |
---|---|
CN102836017B (zh) | 2017-08-11 |
JP2014519931A (ja) | 2014-08-21 |
EP2724689A4 (en) | 2015-03-11 |
CN102836017A (zh) | 2012-12-26 |
EP2724689B1 (en) | 2018-11-21 |
SG195150A1 (en) | 2013-12-30 |
CA2837810A1 (en) | 2012-12-27 |
US10369040B2 (en) | 2019-08-06 |
AU2012272407C1 (en) | 2016-09-22 |
CA2837810C (en) | 2017-11-28 |
MY167553A (en) | 2018-09-14 |
US20130327341A1 (en) | 2013-12-12 |
EP2724689A1 (en) | 2014-04-30 |
US20160346114A1 (en) | 2016-12-01 |
KR20140051265A (ko) | 2014-04-30 |
KR101929197B1 (ko) | 2018-12-17 |
US9445935B2 (en) | 2016-09-20 |
JP6157458B2 (ja) | 2017-07-05 |
AU2012272407B2 (en) | 2016-05-26 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US11717436B2 (en) | Methods and devices for treating sleep apnea | |
JP4680059B2 (ja) | 睡眠時無呼吸を治療するための器具 | |
EP1981431B1 (en) | Device for treating sleep apnea and snoring | |
US9510922B2 (en) | Systems and methods for treatment of sleep apnea | |
KR101623037B1 (ko) | 조절 가능한 연구개 지지물 및 이식방법 | |
US10369040B2 (en) | Layered soft palate support and implantation method | |
US9707122B2 (en) | Systems and methods for treatment of sleep apnea | |
US8001971B2 (en) | Devices, systems, and methods for stabilization or fixation of magnetic force devices used in or on a body | |
KR20110054033A (ko) | 이식형 연구개 지지물 및 이식방법 | |
WO2011116382A2 (en) | Systems and methods for treatment of sleep apnea | |
US20110308529A1 (en) | Systems and methods for treatment of sleep apnea | |
US20160022470A1 (en) | Systems and methods for treatment of sleep apnea | |
AU2006318477A1 (en) | Devices, systems, and methods for stabilization or fixation of magnetic force devices used in or on a body | |
JP2016508830A (ja) | 閉塞性睡眠時無呼吸の治療方法及び装置 | |
Goel et al. | Beyond CPAP in OSA |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 12803487 Country of ref document: EP Kind code of ref document: A1 |
|
WWE | Wipo information: entry into national phase |
Ref document number: 14000598 Country of ref document: US |
|
ENP | Entry into the national phase |
Ref document number: 2014516174 Country of ref document: JP Kind code of ref document: A Ref document number: 2837810 Country of ref document: CA |
|
ENP | Entry into the national phase |
Ref document number: 2012272407 Country of ref document: AU Date of ref document: 20120509 Kind code of ref document: A |
|
NENP | Non-entry into the national phase |
Ref country code: DE |
|
ENP | Entry into the national phase |
Ref document number: 20147001635 Country of ref document: KR Kind code of ref document: A |