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 PDFInfo
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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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- soft palate
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- sleep apnea
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- 229910001000 nickel titanium Inorganic materials 0.000 title claims abstract description 48
- 208000001797 obstructive sleep apnea Diseases 0.000 title claims abstract description 33
- 210000001584 soft palate Anatomy 0.000 title claims abstract description 30
- 208000011580 syndromic disease Diseases 0.000 title claims description 20
- 238000005273 aeration Methods 0.000 title 1
- 239000000463 material Substances 0.000 claims abstract description 10
- 229910045601 alloy Inorganic materials 0.000 claims description 8
- 239000000956 alloy Substances 0.000 claims description 8
- 238000007789 sealing Methods 0.000 claims description 5
- 229910001285 shape-memory alloy Inorganic materials 0.000 claims description 5
- 208000024891 symptom Diseases 0.000 abstract description 4
- 201000002859 sleep apnea Diseases 0.000 abstract description 3
- 239000002184 metal Substances 0.000 abstract description 2
- 229910052751 metal Inorganic materials 0.000 abstract description 2
- 230000001550 time effect Effects 0.000 abstract 1
- 238000000034 method Methods 0.000 description 11
- 230000000694 effects Effects 0.000 description 4
- 230000007774 longterm Effects 0.000 description 4
- 230000008569 process Effects 0.000 description 4
- 206010041235 Snoring Diseases 0.000 description 3
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 3
- 239000008280 blood Substances 0.000 description 3
- 210000004369 blood Anatomy 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 239000007943 implant Substances 0.000 description 3
- 229910052760 oxygen Inorganic materials 0.000 description 3
- 239000001301 oxygen Substances 0.000 description 3
- 229920000728 polyester Polymers 0.000 description 3
- 238000002360 preparation method Methods 0.000 description 3
- 208000019505 Deglutition disease Diseases 0.000 description 2
- 230000007812 deficiency Effects 0.000 description 2
- 230000002950 deficient Effects 0.000 description 2
- 230000003446 memory effect Effects 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 238000011084 recovery Methods 0.000 description 2
- 230000029058 respiratory gaseous exchange Effects 0.000 description 2
- 230000035807 sensation Effects 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 238000009423 ventilation Methods 0.000 description 2
- 238000004804 winding Methods 0.000 description 2
- 206010003497 Asphyxia Diseases 0.000 description 1
- 206010021079 Hypopnoea Diseases 0.000 description 1
- 206010021133 Hypoventilation Diseases 0.000 description 1
- 206010021143 Hypoxia Diseases 0.000 description 1
- 241000158526 Nasalis Species 0.000 description 1
- 208000031481 Pathologic Constriction Diseases 0.000 description 1
- 206010041349 Somnolence Diseases 0.000 description 1
- 208000008784 apnea Diseases 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 238000002485 combustion reaction Methods 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 208000035475 disorder Diseases 0.000 description 1
- 238000009730 filament winding Methods 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 230000007954 hypoxia Effects 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 206010025482 malaise Diseases 0.000 description 1
- 210000004877 mucosa Anatomy 0.000 description 1
- 210000001989 nasopharynx Anatomy 0.000 description 1
- 231100000957 no side effect Toxicity 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 238000007674 radiofrequency ablation Methods 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
- 230000000241 respiratory effect Effects 0.000 description 1
- 210000005181 root of the tongue Anatomy 0.000 description 1
- 230000003860 sleep quality Effects 0.000 description 1
- 230000036262 stenosis Effects 0.000 description 1
- 208000037804 stenosis Diseases 0.000 description 1
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- Orthopedics, Nursing, And Contraception (AREA)
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
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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200720035630 CN201029957Y (en) | 2007-03-26 | 2007-03-26 | Soft palate hyperelastic NiTi bracket for treating obstructive sleep apnea low-aeration syndrome |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200720035630 CN201029957Y (en) | 2007-03-26 | 2007-03-26 | Soft palate hyperelastic NiTi bracket for treating obstructive sleep apnea low-aeration syndrome |
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| Publication Number | Publication Date |
|---|---|
| CN201029957Y true CN201029957Y (en) | 2008-03-05 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200720035630 Expired - Fee Related CN201029957Y (en) | 2007-03-26 | 2007-03-26 | Soft palate hyperelastic NiTi bracket for treating obstructive sleep apnea low-aeration syndrome |
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| CN (1) | CN201029957Y (en) |
Cited By (13)
| 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 |
-
2007
- 2007-03-26 CN CN 200720035630 patent/CN201029957Y/en not_active Expired - Fee Related
Cited By (14)
| 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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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CF01 | Termination of patent right due to non-payment of annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20080305 Termination date: 20160326 |