CN201320227Y - Implanted soft palate support body and implanting method thereof - Google Patents

Abstract

Disclosed is an implanted soft palate support body and an implanting method thereof, wherein the implanted soft palate support body is a flat implant made from materials which can be implanted in a human body for a long time, and comprises a hard palate connecting end and a support body, the hard palate connected end is provided with a connecting structure which is connected with a hard palate, the support body is a flat implant which can be inserted into a soft palate, and the hard palate connecting end is connected on the support body. As the implanted soft palate support body can effectively lift a sunken soft palate, the clogging situation of an upper airway can be improved, thereby reaching the aim of curing OSAHS and snoring disease. Proved by clinic application, adopting the method and implanted appliances of the utility model, the implanted soft palate support body has the advantages of small wound, fast recovery, fast effect and reliable curative effect, and realizes the minimally invasive therapy. Particularly, the lifting extent of lifting the soft palate of patients implanted with the implanted soft palate support body after operation can be adjusted in certain degree under the status of inducing sleep and the monitor of electronic laryngoscope through adjusting the shape and the bending degree of the implanted soft palate support body, which can reach best curing effect, and is deeply welcome by patients.

Description

Embedded soft palate supporter and method for implantation

Technical field

This utility model relates to a kind of embedded soft palate supporter, especially for treatment adult obstructive sleep apnea low syndrome (Obstructive sleep apnea/hypopnea syndrome, embedded soft palate supporter OSAHS) and method for implantation.

Background technology

Adult's obstructive sleep apnea low syndrome (Obstructive sleep apnea/hypopnea syndrome, hereinafter to be referred as: be OSAHS) owing to go up air flue during sleep and occur subsiding and stop up cause a kind of to snore and asphyxia is the sleep disordered breathing disease of Clinical symptoms.Even according to minimum diagnostic criteria, the prevalence of OSAHS is about 4% among the male the adult, and the women is about 2%, and patient's life and health in serious threat.

For the pathogeny of OSAHS, it is generally acknowledged that main cause is the soft tissue obstruction that subsides to occur because the expansion pharynx muscle relaxation of airway open the time is kept in sleep, obstruction plane multidigit is in soft palate, tonsil and the root of the tongue.The method of treatment OSAHS has a lot, is divided into non-operative treatment and operative treatment two classes.Non-surgical treatment mainly contains:

1, continuous positive pressure venti lation (CPAP).Promptly the respirator that continue to produce malleation by a kind of energy closely is connected with patient's nasal surface portion by nose cup, is used for removing when sleeping the air flue soft tissue obstruction that subsides.Though this method effect is better, there is 2/3 patient to be difficult to adapt to approximately, can't have on the respirator sleep.

2, oral appliance.By in the oral cavity, laying a kind of device, draw before making lower jaw reach or tongue, enlarge pharyngeal cavity, airway obstruction when removing sleep.This method has polytype, and certain effect is arranged, but most of patients is difficult to adapt to.Oral appliance has certain zest and foreign body sensation, makes us falling asleep, and life-time service also can cause the temporomandibular joint damage.

As, a kind of method and apparatus that is used to slow down upper respiratory tract obstruction is disclosed in International Application PCT/US2005/001392005.1.3, this device is the mouth tool that is suitable for forming in the population annular seal space, when sleep, bite this device, in the oral cavity, form annular seal space, negative pressure generator connects this device, and when OSAHS took place, this device was effectively with the soft tissue pull-up of patient's tongue and/or upper respiratory tract or be pulled away from posterior pharyngeal wall to open respiratory tract once more greatly.

In Chinese utility model patent ZL200620110299.7, disclose a kind of tongue reach device, be used for the treatment of OSAHS and snoring.This tongue reach device comprises one and a half months type base, and the top of base has the semilune upper tooth bracket that is made of the front and back chimb; Have the camber backboard in the bottom of base, the positive center of base has the anchor tongue hole of a perforation front and rear edge; Have the camber front apron in the bottom of base, under between front and rear baffle, constituting before the carriage of denture.This tongue reach device for the patient up and down before denture the interlock mould of an active is provided, make that muscle up and down is subconscious when sleep to be in a kind of relative tense situation all the time, go up lower jaw and the tongue stable fulcrum of device formation that moves forward like this; Anchor tongue hole provides a comfortable anchor station for the tip of the tongue, and the tongue standard between anchor tongue hole and hyoid bone, has been kept the unobstructed of pars oralis pharyngis air flue, thereby reaches the purpose of treatment OSAHS and snoring.

It is many in addition to be similar among International Application PCT/US2005/001392005.1.3 in the disclosed device and Chinese utility model patent ZL200620110299.7 the patent of disclosed tongue reach device, these patents all are to utilize tooth to be the strong point in the oral cavity, design various utensils and changed when sleep tongue or the tensity or the position of soft palate, thereby reached the purpose of treatment OSAHS and snoring.These utensils will be put into oral cavity and interlock and fix before sleep, but the people constantly alters one's posture and the shape of the mouth as one speaks, and these utensils can not be brought into play effective function often, and are in addition, also uncomfortable, inconvenient when the patient uses.

The Therapeutic Method of operative treatment mainly contains:

1, radio-frequency ablation procedure also claims the low-temperature plasma radio-frequency (RF) ablation, is a kind of Minimally Invasive Surgery method.Mainly be that electrode is thrust in the soft tissue that causes airway obstruction, as positions such as soft palate, tonsil and the roots of the tongue, the energising heating makes tissue coagulation, necrosis, fibrosis, contraction.Certain therapeutical effect is arranged, and effective to lighter case, late result is not good enough, and is invalid to critically ill patient.

2, the palate pharynx is shaped.Fujita was improved to Uvulopalatopharyngoplasty (uvulopalatopharyngoplasty to the PPP of Japanese scholar Ikematus in 1981, UPPP) and after introducing the U.S., document has been reported the multiple improvement art formula based on UPPP in succession, comprise Simmons method, Fairbanks method, Dickson method, Woodson method, Z type uranoplasty, uvula palate lobe art, keep staphyleus PPP (H-UPPP) etc., it has made huge contribution after reaching more to the symptom of improving OSAHS patient.Though the surgical intervention means are benefited countless patients, long-term effect is seen, because of excessively excising mucosa, soft palate organizational structure, damages functional muscle, causes when swallowing anti-complication such as stream, open rhinolalia, the narrow locking of cavum nasopharyngeum of nasal cavity.It is littler how to start a kind of wound, the perhaps method of the operative treatment that carries out in the mode of Wicresoft and corresponding operating theater instruments, the forward position and the emphasis that also just become the research of current OSAHS treatment technology, develop.

3, soft palate implantation.A kind of soft palate implant for the treatment of the braiding of snoring is disclosed in International Application PCT/US2002/0079662002.3.14, fabric is implanted in this invention in soft palate, center of gravity when being used for changing soft palate and swinging and change the aerodynamic characteristics of soft palate with air-flow, improving soft palate and pharyngeal critical air flow velocity, thereby prevent the generation of snoring.But this method can't prevent the generation of OSAHS, because OSAHS block to go up air flue and causes that this method and used implantation instrument can not be used for the treatment of OSAHS owing to soft palate subsides.For serious symptom snoring patient,, increased the risk that OSAHS takes place on the contrary because the weight at soft palate swing position increases.

In sum, art methods treatment OSAHS and snoring, though certain effect is arranged, but still many defectives are arranged, long-term effect is not good enough.Need start new method and treat OSAHS and snoring with the new apparatus of design, this new method wound is as far as possible little, and new apparatus is wanted safety, effective, simple, reliable.

Summary of the invention

Research report and clinical experience show: lax the subsiding of soft palate part is the main cause that causes snoring and OSAHS.Invented the embedded soft palate supporter of following treatment OSAHS and snoring at this cause of disease, described embedded soft palate supporter is with being made up of hard palate link (1) and supporter (2) in the flat implant of the medium-term and long-term material manufacture of implanting of human body.Described hard palate link (1) is provided with the syndeton (11) that is connected with hard palate; Described supporter (2) is the flat implant that can insert in the soft palate; Hard palate link (1) is connected on the supporter (2).

Further, the syndeton (11) on the described hard palate link (1) is a pass structure.

In addition, the syndeton (11) on the described hard palate link (1) can also be a U type clamping structure.

Or the syndeton (11) on the described hard palate link (1) is the button-type structure.

Or the syndeton (11) on the described hard palate link (1) is the rivet type structure.

Or the syndeton (11) on the described hard palate link (1) is the self-expanding latching structure.

Further, the supporter of described embedded soft palate supporter (2) bar shaped or plate shape or clavate or the cancellated flat implant that are.

The flat implant of described supporter (2) has with the human body soft palate radian that the natural torsion degree when lax is complementary.

The supporter of described embedded soft palate supporter (2) is provided with through hole (21).

The supporter of described embedded soft palate supporter (2) is provided with protruding rank or groove (22).

The edge of the supporter of described embedded soft palate supporter (2) is through Passivation Treatment (23).

The coating (24) of improving biocompatibility is arranged on the described supporter (2).

The hard palate link (1) and the supporter (2) of described embedded soft palate supporter are made in one piece.

The hard palate link (1) and the supporter (2) of described embedded soft palate supporter fit together.

The flat implant that the supporter of described embedded soft palate supporter (2) is made up of chip (25) and spring wire (26).

The flat implant (27) that the supporter of described embedded soft palate supporter (2) is made up of the elastic yarn braiding.

The Passivation Treatment at the edge of the supporter of described embedded soft palate supporter (2) is to have coated flexible high molecular material (28).

Described embedded soft palate supporter adopts can be in medium-term and long-term metal material or medical macromolecular materials or the medical biodegradable material manufacturing of implanting of human body.

Further, described metal material is titanium or titanium alloy, Ti-Ni marmem.

In addition, this utility model also comprises the method for implantation of embedded soft palate supporter, described method for implantation is to be fixed on the hard palate (101) with the hard palate link (1) of securing member (116) with embedded soft palate supporter, and the supporter of embedded soft palate supporter (2) inserts in the soft palate (102).

Further, the length that described supporter (2) inserts soft palate (102) the soft palate total length 1/5 to 4/5 between, its best length of inserting is between 2/3 to 3/4.

Embedded soft palate supporter and method for implantation, described embedded soft palate supporter are with being made up of hard palate link and supporter in the flat implant of the medium-term and long-term material manufacture of implanting of human body.The hard palate link is provided with the syndeton that is connected with hard palate; Supporter is the flat implant that can insert in the soft palate; The hard palate link is connected on the supporter.Because embedded soft palate supporter can effectively hold up the soft palate that subsides, can improve and go up the airway obstruction situation, thereby reach the purpose for the treatment of OSAHS and snoring.Clinical practice proves, adopts the apparatus of method of the present utility model and implantation, and it is little to have wound, recovers fast, instant effect, and the reliable advantage of curative effect has realized the purpose of minimally-invasive treatment.The patient of embedded soft palate supporter who particularly implants this utility model is can also be under the induced hypnotic situation after the operation, under the supervision of electronics laryngoscope, by regulating the shape and the flexibility of embedded soft palate supporter, picking-up degree when adjusting the soft palate support within the specific limits, to reach optimum therapeuticing effect, be subjected to patient's welcome deeply.

Description of drawings

Fig. 1 is a human body head side sectional view when nasal respiration.

Fig. 2 is a human body head side sectional view when swallowing.

Schematic diagram when Fig. 3 is OSAHS patient's morbidity.

Fig. 4 is the fundamental diagram of the embedded soft palate supporter of the method schematic diagram of the treatment OSAHS that provides of this utility model and this utility model.

Fig. 5 is that the embedded soft palate supporter of this utility model is implanted in the structural representation in hard palate and the soft palate.

Fig. 6 is that the embedded soft palate supporter of 2 this utility model is consolidated periodic method sketch map at hard palate.

Fig. 7 is that the embedded soft palate supporter of 1 this utility model is consolidated periodic method sketch map at hard palate.

Fig. 8 is that the syndeton on the hard palate link is the structural representation of embedded soft palate supporter of this utility model of pass structure.In this embodiment, syndeton on the hard palate link adopts rectangular through holes type structure, convenience is fixed on the hard palate link of the embedded soft palate supporter of this utility model on the hard palate with securing member (the various securing members that cooperate fastening structure as titanium nail, titanium nut bolt structure, titanium negative and positive card), and can adjust soft palate support within the specific limits and insert length and angle of bend in the soft palate, finally control and regulate soft palate and hold up degree.

Fig. 9 is the structural representation of the embedded soft palate supporter of supporter this utility model of being provided with through hole.In this embodiment, syndeton on the hard palate link adopts rectangular through holes type structure, convenience is fixed on the hard palate link of the embedded soft palate supporter of this utility model on the hard palate with securing member, and can adjust soft palate support within the specific limits and insert length and angle of bend in the soft palate, finally control and regulate soft palate and hold up degree.The difference of Fig. 9 and the described embodiment of Fig. 8 is that the supporter of the described embodiment of Fig. 9 is provided with through hole, to improve supporter and soft palate tissue bond degree.The soft palate tissue can permeate from the through hole that supporter is provided with, and has increased the adhesion of soft palate tissue and supporter.

Figure 10 is the structural representation of the embedded soft palate supporter of this utility model that adopts dolioform pass structure of the syndeton on the hard palate link.In this embodiment, syndeton on the hard palate link is designed to dolioform through-hole structure, the hard palate link that can regulate the embedded soft palate supporter of this utility model easily is fixed on the position on the hard palate, thereby regulate length and angle of bend in the supporter insertion soft palate, finally control and regulate soft palate and hold up degree.In addition, the layout of the through hole that is provided with on the supporter and size are also had any different with Fig. 9.

Figure 11 is the structural representation of the embedded soft palate supporter of this utility model that adopts the manhole structure of the syndeton on the hard palate link.With securing member the hard palate link is fixed on the hard palate in the present embodiment, can makes it to produce the crooked radian that supporter is regulated in plastic deformation, thereby control and adjusting soft palate hold up degree by the bent supports of exerting oneself.The difference of Figure 11 and Fig. 9 and Figure 10 is that the syndeton on the hard palate link of Figure 11 has directly adopted the simplest manhole structure.

Figure 12 is the structural representation of the embedded soft palate supporter of this utility model that adopts U type clamping structure of the syndeton on the hard palate link.In the present embodiment, design has U type clamping structure on the hard palate link, and the U type is clipped on the hard palate, can also reinforce with securing member.Firmly bent supports makes it to produce the crooked radian that supporter is regulated in plastic deformation, thereby control and adjusting soft palate hold up degree.

Figure 13 is the structural representation of the embedded soft palate supporter of this utility model that adopts mountain font U type clamping structure of the syndeton on the hard palate link.In the present embodiment, design has mountain font U type clamping structure on the hard palate link, and mountain font U type is clipped on the hard palate, can also reinforce with securing member.Firmly bent supports makes it to produce the crooked radian that supporter is regulated in plastic deformation, thereby control and adjusting soft palate hold up degree.

What Figure 14 was that the syndeton on the hard palate link adopts is the structural representation of embedded soft palate supporter of this utility model of button-type structure.In the present embodiment, be designed to the button-type structure on the hard palate link, drill through the hole during use on hard palate, snap close fastens hard palate after passing the through hole that bores on the hard palate, forms fixed structure.Firmly bent supports makes it to produce the crooked radian that supporter is regulated in plastic deformation, thereby control and adjusting soft palate hold up degree.The manufactured materials of present embodiment can be selected titanium, particularly can adopt Ti-Ni marmem (Nitinol alloy) to make.Utilize the shape memory characteristic of marmem (selecting recovery temperature usually) to set the geometry that product requires more than recovery temperature at 20 ℃～33 ℃ memorial alloy, during use in cold water (0 ℃～15 ℃), syndeton on the hard palate link is dwindled, after passing the through hole that gets out on the hard palate, under the effect of body temperature, syndeton on the hard palate link returns to the geometry that typing is set during heat treatment, thereby with firm being fixed on the hard palate of embedded soft palate supporter of this utility model.

Figure 15 is the structural representation of the embedded soft palate supporter of this utility model that adopts the rivet type structure of the syndeton on the hard palate link.In the present embodiment, be designed to the rivet type structure on the hard palate link, earlier on hard palate, drill through the hole during use, then rivet is passed the through hole that bores on the hard palate, with special-purpose operating theater instruments with the riveting of hard palate link on hard palate, the formation fixed structure.Firmly bent supports makes it to produce the crooked radian that supporter is regulated in plastic deformation, thereby control and adjusting soft palate hold up degree.

Figure 16 is the structural representation of the embedded soft palate supporter of this utility model that adopts the self-expanding latching structure of the syndeton on the hard palate link.In the present embodiment, be designed to the self-expanding latching structure on the hard palate link, drill through the hole earlier on hard palate during use, then the self-expanding latching structure is passed the through hole that bores on the hard palate, the hard palate link is fixed on the hard palate under the effect of elastic restoring force.Firmly bent supports makes it to produce the crooked radian that supporter is regulated in plastic deformation, thereby control and adjusting soft palate hold up degree.The same with the described embodiment of Figure 15, Figure 16 also can adopt Ti-Ni marmem manufacturing, the convenient implantation.

Figure 17 is the structural representation of embedded soft palate supporter that is provided with this utility model of asperity on supporter.Adopt asperity to strengthen the adhesion of supporter and soft palate in the present embodiment.

Figure 18 is the structural representation of embedded soft palate supporter that is provided with this utility model of annular knurl formula asperity on supporter.Adopt annular knurl formula asperity to strengthen the adhesion of supporter and soft palate in the present embodiment.

Figure 19 is the structural representation of embedded soft palate supporter that is provided with this utility model of biocompatible coating on supporter.On supporter, be provided with biocompatible coating in the present embodiment to improve the biocompatibility of supporter, strengthen the adhesion of supporter and soft palate.

Figure 20 is the structural representation of the embedded soft palate supporter of this utility model that carried out Passivation Treatment of the edge to supporter.In the present embodiment,, to improve the edge effect of supporter, increase the contact area at edge, reach the purpose at passivation edge, and can strengthen the rigidity of supporter by crimping to the edge of supporter having carried out Passivation Treatment.

Figure 21 is the A-A cutaway view of Figure 20.

Figure 22 is the structural representation of embedded soft palate supporter that the edge of supporter has been carried out this utility model of Passivation Treatment with the macromolecular material silk thread.In the present embodiment, the edge of supporter has carried out Passivation Treatment.Earlier at perforate of the edge of supporter or groove, with the edge of medical macromolecular materials silk thread parcel supporter,, increase the contact area at edge then before the Passivation Treatment, reach the purpose at passivation edge to improve the edge effect of supporter.

Figure 23 is the structural representation of embedded soft palate supporter that the edge of supporter has been carried out this utility model of Passivation Treatment with the Ti-Ni marmem silk.In the present embodiment, the chip with Ti-Ni marmem silk thread parcel supporter not only improves the edge effect of supporter, increases the contact area at edge, reaches the purpose at passivation edge, and the supporter flexibility can regulate, and compliance is good.

Figure 24 is that hard palate link and supporter are the structural representation of the embedded soft palate supporter of knockdown this utility model.In the present embodiment, make the part of hard palate link and supporter earlier with medical titanium alloy, then with the braiding of Ti-Ni marmem silk and through the afterbody of the heat treated memory alloy wire knitted body of typing as supporter, at last the silk head end of memory alloy wire knitted body is riveted on the front portion of hard palate link that titanium alloy makes or supporter, the present embodiment support force is strong, simultaneously compliance and elasticity might as well, be convenient to adapt to of the swing requirement of the afterbody of supporter with soft palate.In addition, can adopt macromolecular material silk thread (as dacron thread, polyurethane silk etc.) to make the knitted body of afterbody.

Figure 25 is the structural representation with the embedded soft palate supporter of this utility model of the supporter of memory alloy wire manufacturing.In the present embodiment, make the hard palate link with medical titanium alloy earlier, finalize the design heat treated one-tenth U-shaped body as supporter with manufacturing of Ti-Ni marmem silk and process then, silk head end with memory alloy wire is riveted on the hard palate link that titanium alloy is made at last, and it is strong and compliance is good and the embedded soft palate supporter of this utility model of good springiness to have obtained support force.

Figure 26 is the structural representation of embedded soft palate supporter that is provided with this utility model of herringbone through hole on supporter.On supporter, be provided with the herringbone through hole in the present embodiment, to strengthen the adhesion of supporter and soft palate.

Figure 27 is that supporter is the structural representation of embedded soft palate supporter of this utility model of 3 alloy silks arranged side by side.In the present embodiment, supporter is 3 alloy silks (as titanium alloy wire or Nitinol alloy silk) arranged side by side, and the alloy silk is connected on the hard palate link, and present embodiment has advantage of simple structure.

Figure 28 is that supporter is the structural representation of embedded soft palate supporter of this utility model of screen net structure.In the present embodiment, supporter is the net (as the net of titanium alloy wire braiding or the net of Nitinol alloy silk braiding) of metal wire knitted, and an end of silk screen is connected on the hard palate link, and the other end can insert in the soft palate.

Figure 29 is that the syndeton of hard palate link is the structural representation of embedded soft palate supporter of this utility model of double-pore structure.The fixation of diplopore syndeton on hard palate.

Figure 30 is the structural representation of embedded soft palate supporter that is shaped as this utility model of forked type.In the present embodiment, the syndeton of hard palate link is a double-pore structure, can be securely fixed on the hard palate, and both wings can insert in the soft palate as supporter.

Figure 31 is the structural representation of embedded soft palate supporter of this utility model of single hole forked type.The difference of present embodiment and Figure 30 is that the syndeton of hard palate link is the single hole structure, and all the other are identical.

Figure 32 is the structural representation of embedded soft palate supporter of this utility model of whole punching press template.Present embodiment adopts the manufacturing of whole stamped technology, and the syndeton of hard palate link is a double-pore structure, can be securely fixed on the hard palate, and pressed sheet can insert in the soft palate as supporter.

Figure 33 is the structural representation of embedded soft palate supporter of this utility model of the whole punching press template of the magnetic tape trailer wing.The difference of present embodiment and Figure 32 is to have inlayed the supporter empennage that fabric is made at the afterbody of supporter, and is soft and resilient empennage can be with the soft palate tail swing, and compliance is good.All the other structures are identical with Figure 32.

Figure 34 is the structural representation of a kind of securing member of being used of the embedded soft palate supporter with this utility model.This securing member has adopted titanium nut bolt structure, be particularly suitable on this thin lamellar osseous tissue of hard palate fixed class like with this flat articles of the embedded soft palate supporter of this utility model.Its screw thread has overcome common titanium bone nail difficult fixed shortcoming on hard palate between titanium spare.

Figure 35 is the cutaway view of Figure 34.

Figure 36 is the structural representation that is used for the fixed securing member of diplopore spare after a kind of improve of the described securing member of Figure 34.2 female spiral shells of this securing member are as a whole, and adopt 2 bolts respectively, and the embedded soft palate supporter of this utility model that is particularly suitable among the described embodiment of Figure 29 and Figure 30 the band diplopore uses fixedly the time on hard palate.

Figure 37 is the cutaway view of Figure 36.

Figure 38 is embedded soft palate supporter solid periodic structural representation on hard palate of this utility model.

Figure 39 is the cutaway view of Figure 38.Embedded soft palate supporter solid periodic structure on hard palate of having showed this utility model.

Among the above-mentioned figure: 1 is the hard palate link, and 2 is supporter, and 11 is the syndeton that is connected with hard palate, 21 is through hole, 22 is asperity, and 23 is the edge of Passivation Treatment, and 24 is biocompatible coating, 25 is the chip of supporter, 26 is spring wire, and 27 is fabric, and 28 is the macromolecular material silk thread, 29 is through wires hole or groove, and 30 is the Ti-Ni marmem silk.31 is bolt, and 32 is nut.

101 is hard palate, and 102 is soft palate, and 103 is nasopharynx part, 104 is the rear end of soft palate, and 105 is epiglottis, and 106 is esophagus, 107 is trachea, and 108 is the front end of soft palate, and 109 are a support bone, 110 is nasal cavity, and 111 is the oral cavity, and 112 is tongue, 113 is hard palate-soft palate demarcation line, 114 is the root of the tongue, and 115 is the embedded soft palate supporter of this utility model, and 116 is securing member.

The specific embodiment

Understand this utility model for convenience, now in conjunction with the pathogeny that OSAHS is described referring to figs. 1 to Fig. 3.

Fig. 1 is a human body head side sectional view when nasal respiration.The people is when breathing, and soft palate 102 is sagging naturally, and epiglottis 105 is opened, and air can pass through nasal cavity 110 (perhaps the oral cavity 111, when opening mouth breathing) and enter trachea.

Fig. 2 is a human body head side sectional view when swallowing.The people is when swallowing, and soft palate 102 pastes backward, sealing nasopharynx part 103; Epiglottis 105 is sealed tracheas 107 simultaneously, and food is through the pharyngeal esophagus 106 that enters.

Mechanism figure when Fig. 3 is OSAHS patient's morbidity.When OSAHS patient slept morbidity, the upper respiratory tract soft tissue subsided, and blocked upper respiratory tract, caused hypoventilation, even suffocated.Particularly, when OSAHS takes place, patient's soft palate 102 subsides backward and causes passage between soft palate 102 and the nasopharynx part 103 narrow or sealed this passage, simultaneously root of the tongue soft tissue subsides and has caused passage between the root of the tongue 114 and the soft palate 102 narrow or sealed this passage, thereby hypoventilation when causing breathing perhaps suffocates.Also there is part of O SAHS patient directly to cause passage between soft palate 102 and the nasopharynx part 103 narrow or sealed this passage because of soft palate 102 subsides, also, soft palate 102 directly caused passage between the root of the tongue 114 and the soft palate 102 narrow or sealed this passage simultaneously because of subsiding, thereby hypoventilation when causing breathing perhaps suffocates.

This utility model has adopted the method for implanting soft palate support on hard palate 101 and soft palate 102 that soft palate 102 is held up, thereby enlarges the passage between soft palate 102 and the nasopharynx part 103, and the passage between the root of the tongue 114 and the soft palate 102, reaches the purpose of treatment OSAHS.Particularly, embedded soft palate supporter is made of hard palate link 1 and supporter 2.Hard palate link 1 is provided with the syndeton 11 that is connected with hard palate, and it is firm that the rear end by this syndeton 11 and hard palate 101 is connected and fixed by securing member 116.Supporter 2 is flat implant that certain support force is arranged, supporter 2 is inserted in the soft palate, play the function that promotes or hold up soft palate, thereby enlarge the passage between soft palate 102 and the nasopharynx part 103, and the passage between the root of the tongue 114 and the soft palate 102, reach the treatment OSAHS purpose, with reference to figure 4 to Fig. 7, Figure 38 to Figure 39.

Adopt method of the present utility model and implantation instrument to treat OSAHS, wound is little, recovers fast, and effect is obvious, has realized the purpose of minimally-invasive treatment.Particularly implant the patient of the embedded soft palate supporter of this utility model, after operation, can also be under the induced hypnotic situation, under the supervision of electronics laryngoscope, by regulating the shape and the flexibility of embedded soft palate supporter, picking-up degree when adjusting the support of soft palate within the specific limits is to reach optimum therapeuticing effect.Clinical practice proves, this Therapeutic Method and implantation instrument are little because of wound, curative effect is reliable, treatment OSAHS or and snoring on, be subjected to patient's welcome deeply.

Embodiment 1: the syndeton on the hard palate link is the embedded soft palate supporter of this utility model of pass structure

Selection can be at the medium-term and long-term medical grade titanium sheet material of implanting of human body, manufactures the product of this utility model according to the general processing technique of titanium goods, can obtain the embedded soft palate supporter of this utility model, with reference to figure 8 to Figure 11.Adopt this through hole type syndeton 11, the hard palate link 1 of the embedded soft palate supporter of this utility model can be fixed on the hard palate 101 firmly with securing member 116 (the various securing members that cooperate fastening structure etc. as titanium bone nail, titanium rivet, titanium nut bolt structure, titanium negative and positive card).Being used for localized through hole and can having a plurality ofly on the hard palate link 1, as 2,34 etc., the embedded soft palate supporter of each this utility model can be with 1 in principle, maximum 2 just can be fixed.

In the clinical operation, hold up degree, can adopt following way in order to regulate soft palate.At first can regulate the fixed position of hard palate link 1, the flexibility that next can regulate supporter 2, the 3rd can regulate the length that supporter 2 inserts in the soft palates 102.These three kinds of methods can effectively be regulated soft palate and be held up degree, to reach best therapeutic effect.Syndeton 11 among Fig. 8 on the hard palate link adopts rectangular through holes type structure; It all is that hard palate link 1 for the embedded soft palate supporter of regulating this utility model easily is fixed on the position on the hard palate 101 that syndeton 11 among Figure 10 on the hard palate link adopts dolioform through hole, thereby regulate length and angle of bend that supporter 2 inserts in the soft palate 102, finally control and regulate soft palate picking-up degree and design.According to the technical scheme of this utility model, can also design many kinds of specific products.

Especially meaningfully: after operation, the patient can also be under the supervision of electronics laryngoscope, by regulating the shape and the flexibility of embedded soft palate supporter under the induced hypnotic situation, adjust the picking-up degree of soft palate within the specific limits, to reach optimum therapeuticing effect.Clinical practice proves that this Therapeutic Method and apparatus are little because of wound, curative effect is reliable.The treatment OSAHS or and snoring on, be subjected to patient's welcome deeply.

The embedded soft palate supporter of this utility model can adopt any can manufacturing at the medium-term and long-term material of implanting with the effect of certain force load of human body.Medical titanium metal and titanium alloy are preferred material.Particularly the Ti-Ni marmem in the titanium alloy (as, Nitinol alloy) has phase transformation super-elasticity and shape memory, not only is appropriate to make the afterbody of supporter 2, makes it to adapt to the swing requirement of the afterbody of supporter 2 with soft palate 102; And can utilize its shape memory characteristics to be designed to have the fixed connection structure 11 of auto-lock function.Its hard palate link 1 just can adopt the Ti-Ni marmem manufacturing in the embodiment that Figure 14 and Figure 16 provide.During use, in cold water (0 ℃～15 ℃), syndeton on the hard palate link 1 11 is dwindled, after passing the through hole that gets out on the hard palate, under the effect of body temperature, syndeton 11 on the hard palate link returns to the geometry that typing is set during heat treatment, thereby with firm being fixed on the hard palate of embedded soft palate supporter of this utility model.

Through hole 21 is set on the supporter 2 of the embedded soft palate supporter of this utility model or makes asperity 23, can increase the tissue adherence of supporter 2 and soft palate.The arrangement mode of through hole 21 has many different modes, and asperity 23 also has many different designs, has provided 2 kinds of different specific design schemes in Figure 17 and Figure 18.

Biocompatibility between the embedded soft palate supporter that improves this utility model and the people's tissue can also carry out surface treatment on embedded soft palate supporter, make the coating 24 of improving biocompatibility.Spraying various coatings is one of methods that adopt, both can apply biodegradation material, as polylactic acid, polylactic acid-copolyether, polycaprolactone, polycaprolactone-polyether block copolymer, the polycaprolactone copolymer, polycaprolactone-polyethers-polylactide copolymer, poly-(Acetic acid, hydroxy-, bimol. cyclic ester-polylactide) copolymer, Acetic acid, hydroxy-, bimol. cyclic ester-L-lactide-caprolactone copolymer, polycaprolactone-poly-second lactone-poly-glycolide copolymer and other fatty acid polyglycol lactone copolymers, and the blend of glue protein, chitosan, gelatin or alginate natural high molecular substance or above various materials; Also can apply not absorbable material, as hydroxyapatite, various bioceramices etc.In addition, it also is one of effective ways that titanium and titanium alloy are carried out surface treatment, as titanium and titanium alloy are carried out plasma spraying, makes the loose structure on top layer, makes coating etc. with magnetically controlled sputter method, with reference to Figure 19.

In order to increase the contact area that the formula soft palate is gone into the edge of supporter of planting of this utility model, reach the purpose at passivation edge, can silk thread (as, macromolecular material silk threads such as Ti-Ni marmem silk, polyester thread, polyurethane silk) edge of parcel supporter 2, not only improve the corner effect of supporter 2, increase the contact area at edge, reach the purpose at passivation edge, and the flexibility of supporter 2 can regulate, and compliance is good.Referring to figures 20 through Figure 23.

Embodiment 2: the syndeton on the hard palate link is the embedded soft palate supporter of this utility model of button-type structure

What in the present embodiment, the syndeton on the hard palate link 11 adopted is the button-type structure.Be designed to the button-type structure on the hard palate link 1, drill through the hole during use on hard palate 101, snap close 11 fastens hard palate 101 after passing the through hole that bores on the hard palate, forms fixed structure.Firmly bent supports 2 makes it to produce the crooked radian that supporter 2 is regulated in plastic deformation, thus the picking-up degree of control and adjusting soft palate 102.The manufactured materials of present embodiment can be selected titanium, particularly can adopt Ti-Ni marmem (Nitinol alloy) to make.Utilize the shape memory characteristic of marmem (selecting recovery temperature usually) to set the geometry that product requires more than recovery temperature at 20 ℃～33 ℃ memorial alloy.Elder generation is in cold water (0 ℃～15 ℃) during use, syndeton on the hard palate link 11 is dwindled, after passing the through hole that gets out on the hard palate, under the effect of body temperature, syndeton 11 on the hard palate link returns to the geometry that typing is set during heat treatment, thereby with firm being fixed on the hard palate of embedded soft palate supporter of this utility model.With reference to Figure 14 and Figure 16.

Embodiment 3: the embedded soft palate supporter of combination type this utility model

In the present embodiment, hard palate link 1 and supporter 2 are fabricated structure.Make the part of hard palate link 1 and supporter 2 earlier with medical titanium alloy, then with the braiding of Ti-Ni marmem silk and through the afterbody of the heat treated memory alloy wire knitted body of typing as supporter 2, at last the silk head end of memory alloy wire knitted body is riveted on the front portion of hard palate link 1 that titanium alloy makes or supporter 2, the present embodiment product is when guaranteeing the soft palate support, holding up power, the silk knitted body of the afterbody of supporter 2 has good compliance and elasticity, the afterbody of being convenient to adapt to supporter 2 with soft palate the swing requirement of tail end 104.In addition, the knitted body of afterbody can also adopt medical macromolecular materials silk thread (as dacron thread, polyurethane silk etc.) to make.With reference to Figure 24, Figure 33.

Embodiment 4: the embedded soft palate supporter that this utility model at passivation edge is arranged

In the present embodiment, with the edge of 28 pairs of supporters 2 of medical macromolecular materials silk thread having carried out Passivation Treatment.Earlier at perforate of the edge of supporter or groove 29,, form the edge 23 of Passivation Treatment before the Passivation Treatment then with the edge of medical macromolecular materials silk thread 28 parcel supporters 2.To improve the corner effect of supporter, increase the contact area at edge, reach the purpose at passivation edge.With reference to Figure 22.

Embodiment 5: the embedded soft palate supporter that this utility model of biocompatible coating is arranged

In the present embodiment, on supporter 2, be provided with biocompatible coating 24, strengthen the adhesion of supporter and soft palate.

Biocompatibility between the embedded soft palate supporter that improves this utility model and the people's tissue can carry out surface treatment on embedded soft palate supporter 2, make the coating 24 of improving biocompatibility.Spraying various coatings is one of methods that adopt.Both can apply biodegradation material, as polylactic acid, polylactic acid-copolyether, polycaprolactone, polycaprolactone-polyether block copolymer, the polycaprolactone copolymer, polycaprolactone-polyethers-polylactide copolymer, poly-(Acetic acid, hydroxy-, bimol. cyclic ester-polylactide) copolymer, Acetic acid, hydroxy-, bimol. cyclic ester-L-lactide-caprolactone copolymer, polycaprolactone-poly-second lactone-poly-glycolide copolymer and other fatty acid polyglycol lactone copolymers, and the blend of glue protein, chitosan, gelatin or alginate natural high molecular substance or above various materials; Also can apply not absorbable material, as hydroxyapatite, various bioceramices etc.In addition, it also is one of effective ways that titanium and titanium alloy are carried out surface treatment, as titanium and titanium alloy are carried out plasma spraying, makes the loose structure on top layer, makes coating etc. with magnetically controlled sputter method, with reference to Figure 19.

Embodiment 6: the embedded soft palate supporter of forked type this utility model

In the present embodiment, the shape of embedded soft palate supporter is a forked type.The syndeton 11 that the doubled via structure has formed on the hard palate link 1 is, can be securely fixed on the hard palate 101 by securing member 116, and the both wings of forked type can insert in the soft palate 102 as supporter 2.With reference to Figure 30.

Embodiment 7: a kind of fixed securing member of embedded soft palate supporter that is used for this utility model

Present embodiment has been showed the securing member that a kind of embedded soft palate supporter that is used for fixing this utility model supports.This securing member 116 has adopted the nut bolt structure, is particularly suitable on this thin lamellar osseous tissues of hard palate 101 the fixedly embedded soft palate supporter 115 of this utility model.Its screw thread has overcome common titanium bone nail and has been difficult in the shortcoming that is screwed on the hard palate 101 because of hard palate 101 is too thin between metalwork or working of plastics.With reference to Figure 34 to Figure 39.

Embodiment 8: the method for implantation of the embedded soft palate supporter of this utility model

Method for implantation of the present utility model is: pass through surgical operation, elder generation inserts the supporter 2 of the embedded soft palate supporter 115 of this utility model in the soft palates 102, the length of inserting the total length of soft palate 102 1/5 to 4/5 between, its best length of inserting is between 2/3 to 3/4.Relevant position on hard palate 101 boring again should be fixed on the hard palate 101 of close hard palate-soft palate demarcation line 113 by the hard palate link 1 of securing member 116 with the embedded soft palate supporter 115 of this utility model.Firmly bent supports 2 makes it to produce the crooked radian that supporter 2 is regulated in plastic deformation, thereby the picking-up degree of control and adjusting soft palate 102 reaches best therapeutic effect.Suture tissue is finished implant surgery.

Particularly implant the patient of the embedded soft palate supporter of this utility model, after operation, can also be under the induced hypnotic situation, and under the supervision of electronics laryngoscope, by regulating the shape and the flexibility of embedded soft palate supporter 115, picking-up degree when adjusting soft palate 102 supports within the specific limits is to reach optimum therapeuticing effect.Clinical practice proves that this Therapeutic Method and implantation instrument are little because of wound, curative effect is reliable.The treatment OSAHS or and snoring on, be subjected to patient's welcome deeply.

Should be noted that herein openly can replace with the identical structure of other effect that the embodiment that while this utility model is introduced realizes unique structure of the present utility model with the structure of explanation.Though preferential embodiment of the present utility model is introduced in this article and is illustrated; but those skilled in the art know and know that these embodiment illustrate; those skilled in the art can make countless variations, improvement and replacement; and can not break away from this utility model; therefore, should be according to the next qualification protection domain of the present utility model of the spirit and scope of this utility model appending claims.

Claims (19)

1, embedded soft palate supporter and method for implantation is characterized in that described embedded soft palate supporter is with being made up of hard palate link (1) and supporter (2) in the flat implant of the medium-term and long-term material manufacture of implanting of human body; Described hard palate link (1) is provided with the syndeton (11) that is connected with hard palate; Described supporter (2) is the flat implant that can insert in the soft palate; Hard palate link (1) is connected on the supporter (2).

2,, it is characterized in that the syndeton (11) on the described hard palate link (1) is a pass structure according to the described embedded soft palate supporter of claim 1.

3,, it is characterized in that the syndeton (11) on the described hard palate link (1) is a U type clamping structure according to the described embedded soft palate supporter of claim 1.

4,, it is characterized in that the syndeton (11) on the described hard palate link (1) is the button-type structure according to the described embedded soft palate supporter of claim 1.

5,, it is characterized in that the syndeton (11) on the described hard palate link (1) is the rivet type structure according to the described embedded soft palate supporter of claim 1.

6,, it is characterized in that the syndeton (11) on the described hard palate link (1) is the self-expanding latching structure according to the described embedded soft palate supporter of claim 1.

7,, it is characterized in that described supporter (2) is bar shaped or plate shape or clavate or cancellated flat implant according to the described embedded soft palate supporter of claim 1.

8,, it is characterized in that described supporter (2) has with the human body soft palate radian that the natural torsion degree when lax is complementary according to the described embedded soft palate supporter of claim 1.

9,, it is characterized in that described supporter (2) is provided with through hole (21) according to the described embedded soft palate supporter of claim 1.

10,, it is characterized in that described supporter (2) is provided with protruding rank or groove (22) according to the described embedded soft palate supporter of claim 1.

11, according to the described embedded soft palate supporter of claim 1, the edge that it is characterized in that described supporter (2) is the passivation edge (23) through Passivation Treatment.

12,, it is characterized in that the coating (24) of improving biocompatibility is arranged on the described supporter (2) according to the described embedded soft palate supporter of claim 1.

13,, it is characterized in that described hard palate link (1) and supporter (2) are made in one piece according to the described embedded soft palate supporter of claim 1.

14,, it is characterized in that described hard palate link (1) and supporter (2) fit together according to the described embedded soft palate supporter of claim 1.

15,, it is characterized in that the flat implant that described supporter (2) is made up of chip (25) and spring wire (26) according to the described embedded soft palate supporter of claim 1.

16,, it is characterized in that the flat implant (27) that described supporter (2) is made up of the elastic yarn braiding according to the described embedded soft palate supporter of claim 1.

17, according to the described embedded soft palate supporter of claim 11, the Passivation Treatment that it is characterized in that the edge of described supporter (2) is the passivation edge (23) that has coated flexible high molecular material (28).

18,, it is characterized in that described embedded soft palate supporter adopts metal material or medical macromolecular materials or the medical biodegradable material manufacturing that can implant in the human body midium or long term according to the described embedded soft palate supporter of claim 1.

19,, it is characterized in that described metal material is titanium or titanium alloy, Ti-Ni marmem according to the described embedded soft palate supporter of claim 18.

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