CN201029957Y - Soft palate hyperelastic NiTi bracket for treating obstructive sleep apnea low-aeration syndrome - Google Patents

Soft palate hyperelastic NiTi bracket for treating obstructive sleep apnea low-aeration syndrome Download PDF

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Publication number
CN201029957Y
CN201029957Y CN 200720035630 CN200720035630U CN201029957Y CN 201029957 Y CN201029957 Y CN 201029957Y CN 200720035630 CN200720035630 CN 200720035630 CN 200720035630 U CN200720035630 U CN 200720035630U CN 201029957 Y CN201029957 Y CN 201029957Y
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China
Prior art keywords
support
niti
soft palate
super
sleep apnea
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Expired - Fee Related
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CN 200720035630
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Chinese (zh)
Inventor
陈庆福
胡建刚
刘礼华
赵春霞
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Faersheng-Peiersi Material Sciene-Technology Co Ltd Jiangyin City
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Faersheng-Peiersi Material Sciene-Technology Co Ltd Jiangyin City
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Abstract

The utility model relates to a hyperelastic NiTi frame of soft palate treating obstructive sleep apnea and hypopnea syndrome. The utility model is characterized in that the frame employs the shape memory metal silk material of the hyperelastic NiTi which is coiled to form a closed ligulate structure. The head portion (1) of the frame is a curved circular arc, and the middle portion (2) and the root portion (3) of the frame are straight segments. The utility model has a long time effect, which can avoid being in a recrudescent tendency of the symptom.

Description

Treatment obstructive sleep apnea low-ventilatory syndrome soft palate super-elastic NiTi support
Technical field
This utility model relates to a kind of NiTi alloy bracket, especially relates to the super-elastic NiTi support of a kind of implant into body soft palate internal therapentics obstructive sleep apnea low-ventilatory syndrome (OSAHS).Belong to technical field of medical instruments.
Background technology
The obstructive sleep apnea low syndrome (obstructive sleep apnea-hypopneasyndrome, OSAHS) be meant when sleeping air flue subside block the asphyxia that causes and hypoventilation, with snoring, Sleep architecture disorder, frequently symptom such as blood oxygen saturation decline, daytime is drowsiness take place.The diagnostic criteria of OSAHS is that the research worker by Stanford Univ USA put forward in the seventies the earliest, respiratory air flow is reduced to normal 20~50%, the disordered breathing that descends more than 4% with blood oxygen saturation is called low ventilation simultaneously, as long as patient's mouth and nose air-flow in sleep procedure suspends more than 10 seconds and number of times (the apnea hypopnea index of low ventilation, AHI) surpass per hour 5 times, just can be diagnosed as OSAHS.
At present, mainly contain following several method and treat OSAHS: Uvulopalatopharyngoplasty (Uppp), the auxiliary Uvulopalatopharyngoplasty (LAUP) of laser, low-temperature plasma radio-frequency ablation procedure (RFA) and concha nasalis inferior mucosa lower part excision and the root of the tongue dwindle methods such as art.But it a lot of complication can occur; such as serious pain; dysphagia; the time of recovering normal activity is long, and complication such as velopharyngeal closure deficiency, and foreign body sensation is arranged; dysphagia and stenosis of nasopharynx; and the instrument that uses costs an arm and a leg, and these defectives have had a strong impact on the therapeutic effect of operation, also just can't fundamentally improve patient's sleep quality and quality of life.
The soft palate of U.S. Restore company is implanted Pillar support technology (PIT), is the new method of a kind of simple and effective minimally-invasive treatment OSAHS.PIT is a kind of simple outpatient operation, and minimum operation was introduced into treatment snoring and light/moderate or severe OSAHS in 2003 as sickness rate.PIT provides a kind of simple technology for moderate patient OSAHS and combined surgery.Based on short-term research, PIT is the selecteed patient's of a kind of effective treatment snoring and the method for OSAHS, can with other therapeutic alliance OSAHS that performs the operation.But because the material that the Pillar support uses is the Organic substance polyester, elastic properties of materials is relatively poor, and extruding of implant appears in PIT operation easily, the particularly long-term efficacy that affects the treatment, and operation need repeat or repair.Because the material that the Pillar support uses is the Organic substance polyester, causes long-term efficacy that degradation trend is arranged.Norgard and Maurer are in JIUYUE, 2004 U.S. department of otorhinolaryngology---and reported the long-term effect that relevant Pillar support is implanted in the meeting of head and neck surgery science, they have noticed that many patients snored and have rebounded again after 1 year.
Summary of the invention
The purpose of this utility model is to overcome above-mentioned deficiency, and a kind of effect steady in a long-term that has is provided, and can avoid the treatment obstructive sleep apnea low-ventilatory syndrome soft palate super-elastic NiTi support of symptom bounce-back trend.
The purpose of this utility model is achieved in that a kind of treatment obstructive sleep apnea low-ventilatory syndrome soft palate super-elastic NiTi support, it is characterized in that described support adopts the coiling of super-elastic NiTi shape memory alloy wire material to form sealing tongue shape structure.
This utility model treatment obstructive sleep apnea low-ventilatory syndrome soft palate super-elastic NiTi support, the head of described support is crooked circular arc, the middle part of support and root are straight section.
This utility model treatment obstructive sleep apnea low-ventilatory syndrome soft palate super-elastic NiTi support, the head flank radius of described support is 7mm~12mm.
This utility model treatment obstructive sleep apnea low-ventilatory syndrome soft palate super-elastic NiTi support, the head side arc length of described support is 5mm~15mm, middle part straight section length is 15mm~30mm, and root straight section length is 5mm~10mm, and the support total length is 25mm~55mm.
This utility model treatment obstructive sleep apnea low-ventilatory syndrome soft palate super-elastic NiTi support, the NiTi silk of described support head is thinner by 10%~30% than the diameter of the NiTi silk of mid-stent and afterbody.
This utility model treatment obstructive sleep apnea low-ventilatory syndrome soft palate super-elastic NiTi support, described NiTi diameter of alloy wire is 0.25mm~0.50mm.
This utility model treatment obstructive sleep apnea low-ventilatory syndrome soft palate super-elastic NiTi support, the atomic percent of described NiTi alloy silk composition is: 48at%~52at%Ni, 52at%~48at%Ti.
A kind of preparation method for the treatment of obstructive sleep apnea low-ventilatory syndrome soft palate super-elastic NiTi support, it is characterized in that this method comprises following processing step: at first, adopt the super-elastic NiTi shape memory alloy wire material to turn to the support blank of sealing tongue shape structure, this support blank is fixed in the mould, carry out pre-setting at 400 ℃~440 ℃ then and handle, the processing time is 10min~30min; Be fixed on after the shrend again and carry out secondary typing processing in another mould, temperature is 450 ℃~530 ℃, and the processing time is 20min~50min.
This utility model is started with from the design of support, adopt medical super-elastic NiTi alloy wire to replace the Pillar support polyester material of function persistency difference, avoid Pillar support operation back implant defective such as to extrude, keep simultaneously Pillar support operative treatment process simple, have no side effect, advantage such as recovery time is short, in addition also can be according to patient's soft palate size adjustment stent length.The complication that can avoid operations such as traditional PPP, laser, radio frequency, auxiliary combustion to cause with this soft palate metal rack.
This utility model adopts the soft palate support of super-elastic NiTi memorial alloy preparation to have secular effect, has avoided the trend of symptom bounce-back.
The utlity model has super characteristic and the shape memory effect of playing, the operative treatment process is simple, and recovery time is short, and complication is few, and is applied widely.Show through clinical trial and postoperative Follow-up results, OSAHS patient's curative effect highly significant, detect discovery by sleep-respiratory and blood oxygen: patient's Sleep architecture, disordered breathing and hypoxia situation have all obtained tangible improvement, and patient's subjective sensation is good, do not have related complication to occur.
Description of drawings
Fig. 1 is the perspective view of this utility model soft palate super-elastic NiTi support.
Fig. 2 is the winding process sketch map of this utility model soft palate super-elastic NiTi support.
The specific embodiment
Referring to Fig. 1, this utility model is a kind of treatment obstructive sleep apnea low-ventilatory syndrome soft palate super-elastic NiTi support, and it is to adopt the super-elastic NiTi shape memory alloy wire material to turn to sealing tongue shape structure.
Its preparation method is as follows:
At first, adopt the super-elastic NiTi shape memory alloy wire material to turn to the support blank of sealing tongue shape structure, Fig. 2 is the winding process sketch map of this utility model soft palate super-elastic NiTi support, NiTi filament winding system direction is: A → E → C → F → B → D → A → E → C → F → B, from the A point, end at the B point, wherein AECFB partly is two NiTi silks sections closely arranged side by side, and section NiTi silk support is very close to each other side by side.
This support blank is fixed in the mould, carries out pre-setting at 400 ℃~440 ℃ then and handle, the processing time is 10min~30min; Be fixed on after the shrend again and carry out secondary typing processing in another mould, temperature is 450 ℃~530 ℃, and the processing time is 20min~50min.The gained supporting structure as shown in Figure 1, the head 1 of support is crooked circular arc, the side arc length is 5mm~15mm, flank radius is 7mm~12mm, head front circular arc radius of curvature is 2.5mm~3.5mm, wide is 4.5mm~6mm; The middle part 2 of support and root 3 are straight section, and middle part 2 straight section length are 15mm~30mm; Root straight section 3 length are 5mm~10mm, and root front circular arc radius of curvature is 5mm~7mm, and wide is 9mm~12mm; The support total length is 25mm~55mm.The atomic percent of described NiTi alloy silk composition is: 48at%~52at%Ni, 52at%~48at%Ti.This utility model props up and is placed on soft palate inside, has super characteristic and the shape memory effect of playing.
NiTi diameter of alloy wire described in the utility model is 0.25mm~0.50mm.The NiTi silk of described soft palate NiTi support head 1 is thinner by 10%~30% than the diameter of the NiTi silk of mid-stent 2 and afterbody 3.Make soft palate NiTi support have different support strengths at different positions.

Claims (6)

1. a treatment obstructive sleep apnea low-ventilatory syndrome soft palate super-elastic NiTi support is characterized in that described support adopts the coiling of super-elastic NiTi shape memory alloy wire material to form sealing tongue shape structure.
2. a kind of treatment obstructive sleep apnea low-ventilatory syndrome soft palate super-elastic NiTi support according to claim 1 is characterized in that the head (1) of described support is crooked circular arc, and the middle part of support (2) and root (3) are straight section.
3. a kind of treatment obstructive sleep apnea low-ventilatory syndrome soft palate super-elastic NiTi support according to claim 2 is characterized in that head (1) flank radius 7mm~12mm of described support.
4. a kind of treatment obstructive sleep apnea low-ventilatory syndrome soft palate super-elastic NiTi support according to claim 3, head (1) the side arc length that it is characterized in that described support is 5mm~15mm, middle part (2) straight section length is 15mm~30mm, root straight section (3) length is 5mm~10mm, and the support total length is 25mm~55mm.
5. a kind of treatment obstructive sleep apnea low-ventilatory syndrome soft palate super-elastic NiTi support according to claim 4 is characterized in that the NiTi silk of described support head (1) is thinner by 10%~30% than the diameter of the NiTi silk of mid-stent (2) and afterbody (3).
6. according to one of them described a kind of treatment obstructive sleep apnea low-ventilatory syndrome soft palate super-elastic NiTi support of claim 1~5, it is characterized in that described NiTi diameter of alloy wire is 0.25mm~0.50mm.
CN 200720035630 2007-03-26 2007-03-26 Soft palate hyperelastic NiTi bracket for treating obstructive sleep apnea low-aeration syndrome Expired - Fee Related CN201029957Y (en)

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Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8783258B2 (en) 2008-12-01 2014-07-22 Ethicon, Inc. Implant systems and methods for treating obstructive sleep apnea
US8813754B2 (en) 2009-02-17 2014-08-26 Ethicon, Inc. Magnetic implants and methods for treating an oropharyngeal condition
US8905033B2 (en) 2011-09-28 2014-12-09 Ethicon, Inc. Modular tissue securement systems
US8915252B2 (en) 2008-12-01 2014-12-23 Ethicon, Inc. Implant systems and methods for treating obstructive sleep apnea
US8973582B2 (en) 2011-11-30 2015-03-10 Ethicon, Inc. Tongue suspension device and method
CN102271624B (en) * 2008-10-30 2015-03-11 伊西康公司 Implant systems and methods for treating obstructive sleep apnea
US9144511B2 (en) 2008-08-14 2015-09-29 Ethicon, Inc. Methods and devices for treatment of obstructive sleep apnea
US9161855B2 (en) 2011-10-24 2015-10-20 Ethicon, Inc. Tissue supporting device and method
US9173766B2 (en) 2012-06-01 2015-11-03 Ethicon, Inc. Systems and methods to treat upper pharyngeal airway of obstructive sleep apnea patients
US9326886B2 (en) 2009-10-29 2016-05-03 Ethicon, Inc. Fluid filled implants for treating obstructive sleep apnea
US9877862B2 (en) 2009-10-29 2018-01-30 Ethicon, Inc. Tongue suspension system with hyoid-extender for treating obstructive sleep apnea
US9974683B2 (en) 2009-10-30 2018-05-22 Ethicon, Inc. Flexible implants having internal volume shifting capabilities for treating obstructive sleep apnea
US10470760B2 (en) 2011-12-08 2019-11-12 Ethicon, Inc. Modified tissue securement fibers

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9144511B2 (en) 2008-08-14 2015-09-29 Ethicon, Inc. Methods and devices for treatment of obstructive sleep apnea
CN102271624B (en) * 2008-10-30 2015-03-11 伊西康公司 Implant systems and methods for treating obstructive sleep apnea
US8915252B2 (en) 2008-12-01 2014-12-23 Ethicon, Inc. Implant systems and methods for treating obstructive sleep apnea
US8783258B2 (en) 2008-12-01 2014-07-22 Ethicon, Inc. Implant systems and methods for treating obstructive sleep apnea
US8813754B2 (en) 2009-02-17 2014-08-26 Ethicon, Inc. Magnetic implants and methods for treating an oropharyngeal condition
US9326886B2 (en) 2009-10-29 2016-05-03 Ethicon, Inc. Fluid filled implants for treating obstructive sleep apnea
US9877862B2 (en) 2009-10-29 2018-01-30 Ethicon, Inc. Tongue suspension system with hyoid-extender for treating obstructive sleep apnea
US9974683B2 (en) 2009-10-30 2018-05-22 Ethicon, Inc. Flexible implants having internal volume shifting capabilities for treating obstructive sleep apnea
US8905033B2 (en) 2011-09-28 2014-12-09 Ethicon, Inc. Modular tissue securement systems
US9592046B2 (en) 2011-09-28 2017-03-14 Ethicon, Inc. Modular tissue securement systems
US9161855B2 (en) 2011-10-24 2015-10-20 Ethicon, Inc. Tissue supporting device and method
US8973582B2 (en) 2011-11-30 2015-03-10 Ethicon, Inc. Tongue suspension device and method
US10470760B2 (en) 2011-12-08 2019-11-12 Ethicon, Inc. Modified tissue securement fibers
US9173766B2 (en) 2012-06-01 2015-11-03 Ethicon, Inc. Systems and methods to treat upper pharyngeal airway of obstructive sleep apnea patients

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Granted publication date: 20080305

Termination date: 20160326