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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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
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niti
stent
sleep apnea
obstructive sleep
palate
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CN 200720035630
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Chinese (zh)
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刘礼华
胡建刚
赵春霞
陈庆福
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江阴法尔胜佩尔新材料科技有限公司
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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

治疗阻塞性睡眠呼吸暂停低通气综合症软腭超弹性NiTi支架技术领域本实用新型涉及一种NiTi合金支架,尤其是涉及一种植入人体软腭内部治疗阻塞性睡眠呼吸暂停低通气综合症(OSAHS)的超弹性NiTi支架。 Treatment of obstructive sleep apnea syndrome palate superelastic NiTi stent Technical Field The present invention relates to a NiTi alloy stent, particularly to an implantable within the body of the soft palate treatment of obstructive sleep apnea hypopnea syndrome (with OSAHS) of super elastic NiTi stent. 属医疗器械技术领域。 It is a medical technology equipment. 背景技术阻塞性睡眠呼吸暂停低通气综合征(obstructive sleep apnea-hypopnea syndrome, OSAHS)是指睡时上气道塌陷阻塞引起的呼吸暂停和通气不足、 伴有打鼾、睡眠结构紊乱、频繁发生血氧饱和度下降、白天嗜睡等病征。 BACKGROUND OF THE INVENTION Obstructive sleep apnea syndrome (obstructive sleep apnea-hypopnea syndrome, OSAHS) refers to the airway collapse during sleep apnea caused by lack of obstruction and ventilation, with snoring and sleep disordered structure, frequently occurring oxygen desaturation, daytime sleepiness and other symptoms. OSAHS的诊断标准最早是由美国斯坦福大学的研究人员在70年代提出来的,将呼吸气流减少到正常的20~50%,同时伴有血氧饱和度下降4%以上的呼吸紊乱称为低通气,只要患者在睡眠过程中口鼻气流暂停10秒以上和低通气的次数(apneahypopnea index, AHI)超过每小时5次,就可以诊断为OSAHS o目前,主要有以下几种方法来治疗OSAHS:悬雍垂腭咽成形术(Uppp)、 激光辅助悬雍垂腭咽成形术(LAUP)、低温等离子射频消融术(RFA)以及下鼻甲粘膜下部分切除术及舌根縮小术等方法。 OSAHS diagnostic criteria was first used by researchers at Stanford University presented to the 1970s, to reduce the flow of breathing gas to the normal 20% to 50%, accompanied by decreased oxygen saturation more than 4% of respiratory disorders referred hypoventilation as long as the treatment of patients during sleep times (apneahypopnea index, AHI) more than 5 times per hour, can be diagnosed OSAHS o currently, there are several ways to pause for 10 seconds or oronasal flow and hypopneas OSAHS: suspended Yong vertical UPPP (UPPP), laser-assisted surgery uvulopalatopharyngoplasty (LAUP), radiofrequency ablation (RFA) and a lower partial resection of the inferior turbinate mucosa and tongue reduction technique or the like. 但是其会出现很多并发症,诸如严重疼痛,吞咽困难,恢复正常活动的时间长,并且并发症如腭 But it will be a lot of complications, such as severe pain, difficulty swallowing, resume normal activities for a long time, and complications such as palate

咽闭合不足,有异物感,吞咽困难和鼻咽狭窄,以及使用的仪器价格昂贵, 这些缺陷严重影响了手术的治疗效果,也就无法从根本上改善患者的睡眠质量和生活质量。 Velopharyngeal insufficient, foreign body sensation, dysphagia and nasopharyngeal stenosis, as well as the use of expensive equipment prices, these defects seriously affect the treatment effect of surgery, it will not be able to improve the quality of sleep and quality of life fundamentally. 美国Restore公司的软腭植入Pillar支架技术(PIT),是一种简单有效的微创治疗OSAHS的新方法。 Restore America's Pillar palatal implant stent technology (PIT), the new method is a simple and effective minimally invasive treatment of OSAHS. PIT是一种简单的门诊手术,作为发病率极小的手术在2003年被引进治疗打鼾和轻/重度OSAHS。 PIT is a simple outpatient procedure, as minimal incidence of surgical treatment of snoring is introduced and light / severe OSAHS 2003. PIT为中度OSAHS 病人和联合手术提供了一种简单的技术。 PIT provides a simple technique to moderate OSAHS patients and joint surgery. 基于短期研究,PIT是一种有效的治疗被选择的病人的打鼾和OSAHS的方法,可以和其他手术联合治疗OSAHS。 Snoring and OSAHS method of short-term studies, PIT is an effective treatment for selected patients based combination therapy may be surgical and other OSAHS. 但是,由于Pillar支架使用的材料是有机物聚酯,材料弹性较差, PIT手术容易出现植入物的挤出,影响疗效特别是长期疗效,手术需要重复进行或修补。 However, since the material used is organic scaffold Pillar polyester, less flexible materials, the PIT surgical implant extruded readily appear to affect the efficacy especially long-term efficacy, or repair operation should be repeated. 由于Pillar支架使甩的材料是有机物聚酯,致使长期疗效有退化趋势。 Because Pillar stand the rejection of the material is organic polyester, resulting in long-term efficacy has degradation trends. Norgard和Maurer在2004年9月美国耳鼻喉禾ij——头颈外科学术会议上报道了有关Pillar支架植入的长期效果,他们注意到了许多病人在一年后打鼾又反弹了。 Norgard and Maurer in September 2004 American Academy of Otolaryngology Head and Neck Surgery Wo ij-- conferences reported stent related Pillar long-term effects, they noticed that many patients after one year of snoring come back. 发明内容本实用新型的目的在于克服上述不足,提供一种具有长期稳定的效果, 可以避免症状反弹趋势的治疗阻塞性睡眠呼吸暂停低通气综合症软腭超弹性NiTi支架。 The present invention aims to overcome these shortcomings, the effect of having to provide long-term stability, to avoid rebound symptoms of obstructive sleep apnea syndrome soft palate super elastic NiTi stent. 本实用新型的目的是这样实现的: 一种治疗阻塞性睡眠呼吸暂停低通气综合症软腭超弹性NiTi支架,其特征在于所述支架采用超弹性NiTi形状记忆合金丝材绕制而成封闭舌形结构。 The object of the present invention is realized: A method of treating obstructive sleep apnea hypopnea syndrome palate superelastic NiTi stent, wherein said stent using NiTi superelastic shape memory alloy wire wound from the closure tongue structure. 本实用新型治疗阻塞性睡眠呼吸暂停低通气综合症软腭超弹性NiTi支架,所述支架的头部为弯曲圆弧形,支架的中部和根部为直段。 The present invention is the treatment of obstructive sleep apnea syndrome palate superelastic NiTi stent, the stent is curved head of a circular arc shape, and the central straight segment of the stent root. 本实用新型治疗阻塞性睡眠呼吸暂停低通气综合症软腭超弹性NiTi支架,所述支架的头部侧面曲率半径为7mm〜12mm。 The present invention is the treatment of obstructive sleep apnea syndrome palate superelastic NiTi stent, a radius of curvature of the head side of the stent is 7mm~12mm. 本实用新型治疗阻塞性睡眠呼吸暂停低通气综合症软腭超弹性NiTi支架,所述支架的头部侧面弧长为5mm〜15mm,中部直段长度为15mm〜30mm,根部直段长度为5mm〜10mm,支架总长度为25mm〜55mm。 The present invention is the treatment of obstructive sleep apnea syndrome superelastic NiTi stent soft palate, the side of the head cradle arc length 5mm~15mm, the length of the central straight section 15mm~30mm, straight length of the root 5mm~10mm The total length of the stent of 25mm~55mm. 本实用新型治疗阻塞性睡眠呼吸暂停低通气综合症软腭超弹性NiTi支架,所述支架头部的NiTi丝比支架中部和尾部的NiTi丝的直径细10%〜30%。 The present invention is the treatment of obstructive sleep apnea syndrome palate superelastic NiTi stent, a wire stent NiTi wire NiTi stent-head and tail of the central small diameter 10% ~ 30%. 本实用新型治疗阻塞性睡眠呼吸暂停低通气综合症软腭超弹性NiTi支架,所述NiTi合金丝的直径为0.25mm〜0.50mm。 The present invention is the treatment of obstructive sleep apnea syndrome palate superelastic NiTi stent, the diameter of the NiTi alloy wire is 0.25mm~0.50mm. 本实用新型治疗阻塞性睡眠呼吸暂停低通气综合症软腭超弹性NiTi支架,所述的NiTi合金丝成分的原子百分比为:48at%~52at%Ni, 52at%~48at%Ti。 The present invention is the treatment of obstructive sleep apnea syndrome palate superelastic NiTi stent atomic percent of the alloy wire of NiTi component: 48at% ~ 52at% Ni, 52at% ~ 48at% Ti. 一种治疗阻塞性睡眠呼吸暂停低通气综合症软腭超弹性NiTi支架的制备方法,其特征在于该法包括以下工艺步骤:首先,采用超弹性NiTi形状记忆合金丝材绕制成封闭舌形结构的支架毛坯,将该支架毛坯固定在一模具内,然后在400°C~440°C进行预定型处理,处理时间为10min〜30min; 水淬后再固定在另一模具内进行二次定型处理,温度为450°C~530°C,处理时间为20min〜50min。 A method of treating the soft palate preparing hypoventilation syndrome superelastic NiTi stent obstructive sleep apnea, which is characterized in that the method comprises the following process steps: First, a NiTi superelastic shape memory alloy wire is wound in a closed configuration of the tongue blank holder, the blank holder is fixed in a mold and then subjected to a predetermined type of processing 400 ° C ~ 440 ° C, the processing time is 10min~30min; water quenching after the secondary fixed routine processing in another mold, temperature of 450 ° C ~ 530 ° C, the treatment time is 20min~50min.

本实用新型从支架的设计入手,采用医用超弹性NiTi合金丝材代替功能持久性差的Pillar支架聚酯材料,避免Pillar支架手术后植入物挤出等缺陷,同时保持Pillar支架手术治疗过程简单、无副作用、恢复时间短等优点,另外还可根据患者软腭尺寸调节支架长度。 The present invention starts from the design of the stent, the medical use of superelastic NiTi alloy wire instead of a polyester material Pillar scaffold functional poor durability and avoid post surgical implant stent Pillar extrusion defects, while maintaining stent Pillar surgical treatment is simple, no side effects, shorter recovery time, etc., in addition to adjusting the length of the stent may be of the soft palate of the patient size. 用这种软腭金属支架可避免传统的腭咽成形术、激光、射频、辅助燃烧等手术引起的并发症。 Such soft palate with conventional metal stents can avoid complications uvulopalatopharyngoplasty, laser, radio frequency, and other auxiliary combustion caused by surgery. 本实用新型采用超弹性NiTi记忆合金制备的软腭支架具有长期的效果,避免了症状反弹的趋势。 The present invention were prepared superelastic NiTi shape memory alloy stent having a long-term effect of the soft palate, the tendency to avoid rebound symptoms. 本实用新型具有超弹特性和形状记忆效应,手术治疗过程简单,恢复时间短,并发症少,适用范围广。 The present invention having superelastic properties and shape memory effect, surgical treatment is simple and short recovery times, fewer complications, a wide range. 经过临床试验及术后随访结果表明, OSAHS患者疗效非常显著,通过睡眠呼吸和血氧检测发现:患者的睡眠结构、呼吸紊乱和低氧情况均得到了明显的改善,患者本人的主观感觉良好, 没有相关并发症出现。 After clinical trials and postoperative follow-up results show that efficacy in patients with OSAHS very significant, sleep apnea and oxygen through testing found: the patient's sleep structure, respiratory disorders and hypoxia circumstances has been significantly improved, the patient's own subjective feeling good, no complications. 附图说明图1为本实用新型软腭超弹性NiTi支架的立体结构示意图。 BRIEF DESCRIPTION OF THE schematic perspective view of the soft palate new NiTi superelastic stent of Figure 1 the present invention. 图2为本实用新型软腭超弹性NiTi支架的绕制过程示意图。 FIG 2 of the present invention the soft palate superelastic NiTi stent schematic winding process. 具体实施方式参见图1,本实用新型为一种治疗阻塞性睡眠呼吸暂停低通气综合症软腭超弹性NiTi支架,它是采用超弹性NiTi形状记忆合金丝材绕制成封闭舌形结构。 DETAILED DESCRIPTION Referring to FIG 1, the present invention is a method of treating obstructive sleep apnea hypopnea syndrome superelastic NiTi stent soft palate, it is the use of superelastic NiTi shape memory alloy wire is wound in a closed configuration tongue. 其制备方法如下:首先,采用超弹性NiTi形状记忆合金丝材绕制成封闭舌形结构的支架毛坯,图2为本实用新型软腭超弹性Nm支架的绕制过程示意图,Nm丝绕制方向为:A—E—C—F—B—D—A—E—C—F—B,从A点开始,结束于B点,其中AECFB部分为两根NiTi丝紧密并列段,并列段NiH丝支架没有间隙。 It was prepared as follows: Firstly, NiTi superelastic shape memory alloy wire wound closure blank holder made of tongue-shaped configuration, the soft palate novel wound superelastic stent Nm 2 is a schematic diagram of a practical process, filament wound direction Nm : A-E-C-F-B-D-A-E-C-F-B, starting from point A and ends at point B, which is a two part AECFB NiTi wire segments closely juxtaposed, parallel wire stent segment NiH there is no gap. 将该支架毛坯固定在一模具内,然后在400°C^40°C进行预定型处理, 处理时间为10min〜30min;水淬后再固定在另一模具内进行二次定型处理, 温度为450°C〜530T,处理时间为20min〜50min。 The blank holder is fixed in a mold and then subjected to a predetermined type of processing 400 ° C ^ 40 ° C, the processing time is 10min~30min; water quenching after the secondary fixed routine processing in another mold, a temperature of 450 ° C~530T, treatment time 20min~50min. 所得支架结构如图1所示,支架的头部1为弯曲圆弧形,侧面弧长为5mm〜15mm,侧面曲率半径为7mra〜12mm,头部正面圆弧曲率半径为2.5mm〜3.5mm,宽为4.5mm^mm;支架的中部2和根部3为直段,中部2直段长度为15mm〜30mm;根部直段3长度为5mm〜l(tom,根部正面圆弧曲率半径为5mm〜7mm,宽为9mm〜12mm;支架总长度为25mm〜55mm。所述的NiH 合金丝成分的原子百分比为:48at%~52at%Ni, 52at°/(r48at%Ti。本实用新型支架置于软腭内部,具有超弹特性和形状记忆效应。本实用新型所述NiTi合金丝的直径为0.25mm~0.50mm。所述的软腭NiTi支架头部1的NiTi丝比支架中部2和尾部3的NiTi丝的直径细10%~30%。使软腭NiTi支架在不同的部位具有不同的支撑强度。 The resulting stent structure shown in Figure 1, a head support of a curved circular arc shape, the arc length of the side 5mm~15mm, side curvature radius 7mra~12mm, arc radius of curvature of the front head portion is 2.5mm~3.5mm, a width of 4.5mm ^ mm; the middle root portion 2 and the holder 3 is a longitudinal section of a linear straight section 2, central 15mm~30mm; root length of the straight section 3 5mm~l (tom, front radius of curvature of the arc root is 5mm~7mm a width of 9mm~12mm; overall length of the stent NiH 25mm~55mm atomic percent of the alloy wire of composition: 48at% ~ 52at% Ni, 52at ° / (r48at% Ti stent of the present invention is placed inside the soft palate. having superelastic and shape memory effect properties. the diameter of the present invention is a NiTi alloy wire soft palate NiTi stent according to 0.25mm ~ 0.50mm. NiTi wire 1 head holder 2 than the middle and tail of NiTi filaments 3 the diameter of fine 10% to 30% NiTi stent having different soft palate support strength in different sites.

Claims (6)

1、一种治疗阻塞性睡眠呼吸暂停低通气综合症软腭超弹性NiTi支架,其特征在于所述支架采用超弹性NiTi形状记忆合金丝材绕制而成封闭舌形结构。 1. A method of treating obstructive sleep apnea syndrome palate superelastic NiTi stent, wherein said stent using NiTi superelastic shape memory alloy wire wound from a tongue closure structure.
2、 根据权利要求1所述的一种治疗阻塞性睡眠呼吸暂停低通气综合症软腭超弹性NiTi支架,其特征在于所述支架的头部(l)为弯曲圆弧形,支架的中部(2)和根部(3)为直段。 2 A method according to claim 1 treatment of obstructive sleep apnea syndrome palate superelastic NiTi stent, characterized in that the head of the bracket (l) a curved circular arc shape, the center stand (2 ) and a root portion (3) is a straight segment.
3、 根据权利要求2所述的一种治疗阻塞性睡眠呼吸暂停低通气综合症软腭超弹性NiTi支架,其特征在于所述支架的头部(l)侧面曲率半径7mm〜12mm。 3 A method according to claim 2 treatment of obstructive sleep apnea syndrome palate superelastic NiTi stent, characterized in that the head of the bracket (l) the radius of curvature of the side 7mm~12mm.
4、 根据权利要求3所述的一种治疗阻塞性睡眠呼吸暂停低通气综合症软腭超弹性NiTi支架,其特征在于所述支架的头部(l)侧面弧长为5mm〜15mm,中部(2)直段长度为15mm〜30mm,根部直段(3)长度为5mm〜10mm,支架总长度为25mm〜55mm。 4, according to one of the claim 3, wherein the treatment of obstructive sleep apnea syndrome palate superelastic NiTi stent, characterized in that the head of the bracket (l) side arc length 5mm~15mm, middle (2 ) straight segment length 15mm~30mm, root straight section (3) length 5mm~10mm, the total length of the stent of 25mm~55mm.
5、 根据权利要求4所述的一种治疗阻塞性睡眠呼吸暂停低通气综合症软腭超弹性NiTi支架,其特征在于所述支架头部(l)的NiTi丝比支架中部(2)和尾部(3)的NiTi丝的直径细10%~30%。 5, in accordance with claim 4, wherein the treatment of obstructive sleep apnea syndrome palate superelastic NiTi stent, wherein said head holder (l) than the middle of the NiTi wire holder (2) and tail ( 3 small diameter) of the NiTi wire 10% to 30%.
6、 根据权利要求1~5其中之一所述的一种治疗阻塞性睡眠呼吸暂停低通气综合症软腭超弹性NiTi支架,其特征在于所述NiTi合金丝的直径为0.25匪〜0.50mm。 6, in accordance with claim 1 to claim 5 wherein one of said treatment of obstructive sleep apnea syndrome palate superelastic NiTi stent, characterized in that the NiTi alloy wire diameter is 0.25 bandit ~0.50mm.
CN 200720035630 2007-03-26 2007-03-26 Soft palate hyperelastic NiTi bracket for treating obstructive sleep apnea low-aeration syndrome CN201029957Y (en)

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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

Cited By (13)

* Cited by examiner, † Cited by third party
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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
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