CN102512271A - Transcatheter implantation controllable aortic valvular stent - Google Patents
Transcatheter implantation controllable aortic valvular stent Download PDFInfo
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- CN102512271A CN102512271A CN2011103667672A CN201110366767A CN102512271A CN 102512271 A CN102512271 A CN 102512271A CN 2011103667672 A CN2011103667672 A CN 2011103667672A CN 201110366767 A CN201110366767 A CN 201110366767A CN 102512271 A CN102512271 A CN 102512271A
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Abstract
The invention relates to a transcatheter implantation controllable aortic valvular stent which comprises two parts, namely a stent and an artificial valve, wherein the stent is made of a nickel-titanium alloy metal wire, is of a cage-type net structure and comprises a cage part, a low end aorta horizontal part, an intermediate bonding edge horizontal part and an upper end valve ring horizontal cone part from bottom to top; the center of the top end of the upper end valve ring horizontal cone part is provided with a stainless steel rivet; and the artificial valve is fixed on the intermediate bonding edge horizontal part, the integral structure of the artificial valve is similar to an autologous aortic valvular structure, the curve shape of the artificial valve is opposite to the shape of the aortic sinus, and the artificial valve is fixed on the intermediate bonding edge horizontal part by using a propylene wire in a continuous suture manner. According to the invention, the thoracic surgery is not needed when location deviation or unsatisfactory position occurs in a first-releasing position, the position of the artificial valve stent can be regulated, so that the probability of causing fatal complications such as coronary blockage, high conduction blockage and the like is reduced.
Description
Technical field
The invention belongs to technical field of medical treatment mechanical, particularly relate to a kind of through conduit implantation controllable type aortic valve stent.
Background technology
Degeneration aortic valve disease was meant normal valve or on the basis of slight valve abnormalities; With advancing age; Aortic valve connective tissue generation degeneration and fibrosis make that valve thickens, hardening, distortion and calcium deposition, cause valvular stenosis with (or) incompetence.In recent years aortic valve property narrow (AS) become old people's heart failure, arrhythmia, the main diseases of fainting and dying suddenly therefore; Domestic sickness rate is 2%-5% in China; And after American-European countries is positioned at coronary heart disease and hypertension, occupy the 3rd.
Aspect the treatment of aortic valve disease, the surgical valve replacement is traditional effective Therapeutic Method; Patient's polyphyly advanced age of this type disease; Be associated with many organ diseases simultaneously, physical qualification is difficult to accept surgical operation, becomes to treat hopeless patient clinically.The symptom that the measure of ideal treatment aortic valve disease should improve the patient can prolong its life-span again; But degeneration aortic valve disease disease is still not fully aware of; Can't carry out etiological treatment, not have its development of effective method containment yet, medication effect is not good.The surgery valve replacement is that a kind of main treatment is selected in the past.The percutaneous aortic valve sacculus urethroptasty of carrying out in one's early years once was used to treat aortic stenosis, but no matter was that monocentric data or polycentric materials for registration are all found medium-term and long-term poor effect.
In recent years, some scholars have carried out metathetical basis of percutaneous aortic valve film and clinical research both at home and abroad, and obtain some breakthrough progress.For the metathetical high-risk senile aorta degeneration patient of needs surgery valve, a kind of efficacious therapy method is provided.2002, Cribier etc. successfully carried out the people through conduit aortic valve implantation, and up to now, research all over the world all shows: surgery changes lobe or there is high risk patient in the surgery heart valve replacement surgery for carrying out, and this new technique is safely and effectively.Although carry out the high-risk patient that is mostly of TAVR operation, back 30 days survival rates of postoperative success are higher than 90%, TAVR postoperative patient hemodynamic index be improved significantly.The percutaneous aortic valve replacement operation of existing nearly 20000 examples in the whole world.
Be applied to the clinical two kinds of band valve brackets that mainly contain at present: the Edwards valve bracket (Cribier-Edwards of system; Edwards SAPIEN; SAPIEN XT, Edwards Lifesciences Inc., Irvine, United States) and the CoreValve valve bracket (CoreValve of system; Medtronic, Minneapolis, MN, United States).The valve of Edwards SAPIEN band valve bracket is processed by bovine pericardium; Suture group is contained in (SAPIEN XT support is processed by cochrome) on the stainless steel stent; This valve bracket model is divided into diameter 23 and 26 millimeters two kinds; This valve system is preloaded on the dilating sacculus, carries, is positioned aortic valve and gets through 22Fr or 24Fr (corresponding diameter 23mm and 26mm valve bracket respectively) Retroflex conduit; By perspective, angiography or esophagus ultrasound kinetocardiogram location, (180-220 time/minute) dilating sacculus discharges support under the temporary pacemaker overdrive pacing.
The artificial valve that the CoreValve valve bracket is packed by 3 pieces of Cor Sus domestica is sewn on the Nitinol self-expandable stent; This support has 26 millimeters and two kinds of models of 29 mm dias to use; In most of the cases, can use the 18Fr conduit to carry, can not need cut the exposure femoral artery through femoral artery.When carrying out TAVR, the location is to be main with the angiography guiding, and after valve bracket was in place, the patient returned and removes the sheath pipe, and the band valve bracket is expanded voluntarily, and heart and blood vessel are not had over-drastic stimulation.
Announced several up-to-date results of study in the TCT meeting in 2010 about TAVI, encouraging.A result who is research was followed up a case by regular visits to 1 year about PARTNER announces; PARTNER research mainly is for being not suitable for the narrow patient of the operating aortic valve of row, the prediction of using the Edwards balloon expandable valve to carry out TAVI treatment and traditional therapy head to head to compare, at random, comparative study.The result confirms; Postoperative was followed up a case by regular visits in 30 days, and the full cause death rate and the cardiovascular mortality of TAVI group quantitatively will be higher than the traditional treatment group, but the statistics zero difference; And after following up a case by regular visits to 1 year; The full cause death rate and the cardiovascular mortality of TAVI group significantly are lower than the traditional treatment group, and difference has statistical significance, and admission rate also is starkly lower than the traditional treatment group once more.But followed up a case by regular visits to middle discovery in 30 days after surgery, the incidence rate and the massive hemorrhage incidence rate of TAVI group vascular complication all are significantly higher than traditional group, and simultaneously, the incidence rate of apoplexy also is significantly higher than the traditional treatment group.
Another is that Nicolo professor Piazza from Germany has announced safety and study on the efficiency about 18F CorValve valve bracket system; Research has related to the 126 routine patients at 9 tame heart centers altogether, and the Follow-up results in 2 years shows application 1 8F CorValve valve bracket, and the survival rate of its 1 year and 2 years is respectively 72% and 60%; Postoperative was followed up a case by regular visits in 2 years; Effectively the 0.72cm2 of valve orifice area before the art is increased to 1.71cm2, strides the 47mmHg of valve pressure reduction before the art simultaneously and is reduced to 9mmHg, removes a routine patient and occurs in 17 months infective endocarditis has taken place; It is narrow that aortic valve appears in all the other none examples, valve periphery thrombosis or valve displacement.And the incidence rate of aortic regurgitation is lower, removes the valve periphery that wherein has 1 example to occur manifest symptom after surgery in 127 days and leaks, and all the other are merely 0 to 1 grade above patient's aortic regurgitation between follow-up period of 90%.But regrettably, follow up a case by regular visits to and have 31.3% patient to accept the implantation of permanent pacemaker in the period of 2.
The most key in the TAVI operation is the location of stent valve.The aortic valve regional structure is complicated, and left and right sides opening coronarius is arranged on the lobe, and interventricular septum portion passes to bundle branch and passes through under the lobe, and Bicuspid valve is adjoined on the right side, and is inaccurate if the location discharges, and fatal complication such as arteria coronaria stops up, height conduction block possibly occur.And the factor that the location is discharged influence is except the performance of stent valve and delivery sheath, and the most importantly blood flow impact that causes of the pressure variation that produces of the contraction of heart and diastole badly influences the accurate release of support.Along with continuous advancement in technology, the incidence rate of the deviations that TAVI operation valve bracket is inserted descends to some extent.Yet, clinical two kinds of valve system (Corevalve and Edwards) commonly used not recyclable with reorientate, so the situation of deviations can't be eradicated after valve bracket is implanted.
In implantation process, Edwards band lobe support discharges the probability of almost not reorientating by the rapid expanse of sacculus under the ventricle rapid pacing.And CoreValve band lobe support has relative advantage, but just when part discharges, can adjust, and also can't adjust in case discharge fully.But generally speaking, both do not have tangible difference aspect deviations.In case can't mean that valve bracket implants in the aorta to valve bracket adjustment, deviations appears or the position is undesirable, promptly mean operative failure, not adjustment and localized chance again can only be opened breast and open heart as being taken out support.
Summary of the invention
Technical problem to be solved by this invention provides a kind of cage modle can adjust recyclable aortic valve prosthesis's support, deviations or position occur in off-position first when undesirable, does not need open chest surgery, directly can adjust worker's valve bracket position.
The technical solution adopted for the present invention to solve the technical problems is: provide a kind of and implant the controllable type aortic valve stent through conduit; Comprise support and artificial valve's two parts; Described support is the cage modle RF, comprises cage portion, lower end aorta horizontal component, middle edge horizontal component and the upper end lobe ring horizontal circle tapering part of combining from the bottom to top; The center, top of described upper end lobe ring horizontal circle tapering part is provided with the rustless steel riveting; Combine on the edge horizontal component in the middle of described artificial valve is fixed in; Described artificial valve's overall structure with from body aortic valve similar, the opposite shape of curve shape and aortic sinus.
Described rustless steel riveting matches with carrying the vertical external screw thread of rope through its inner female thread.
Described artificial valve is fixed on the middle combination edge horizontal component with the mode of propylene line with continuous stitching.
Described support adopts Nitinol tinsel material.
Beneficial effect
The present invention relates to a kind of through conduit implantation controllable type aortic valve stent; Through adopting the netted supporting structure of cage modle; Deviations or position appear in off-position first when undesirable; Do not need open chest surgery, directly can adjust worker's valve bracket position, reduce the probability that fatal complication such as arteria coronaria obstruction, height conduction block occurs.
Description of drawings
Fig. 1 is the supporting structure sketch map.
Fig. 2 is the support vertical view.
Fig. 3 is the valve structure sketch map.
The specific embodiment
Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiment only to be used to the present invention is described and be not used in the restriction scope of the present invention.Should be understood that in addition those skilled in the art can do various changes or modification to the present invention after the content of having read the present invention's instruction, these equivalent form of values fall within the application's appended claims institute restricted portion equally.
Embodiment 1
Shown in Fig. 1-3; The present invention is a kind of through conduit implantation controllable type aortic valve stent; Comprise support and artificial valve's 6 two parts; Described support is the cage modle RF, comprises cage portion 5, lower end aorta horizontal component 1, middle edge horizontal component 2 and the upper end lobe ring horizontal circle tapering part 3 of combining from the bottom to top; Described upper end lobe ring horizontal circle tapering part 3 makes support be fixed in aorta wall and can be parallel to blood flow direction by sizing stop, and its radial radiation power can prevent artificial valve 6 displacement, avoids the generation of perivalvular leakage; The center, top of described upper end lobe ring horizontal circle tapering part 3 is provided with rustless steel riveting 4; Combine on the edge horizontal component 2 in the middle of described artificial valve 6 is fixed in; Described artificial valve 6 is that laser cutting forms after being handled by the defat of pig pericardium channel, glutaraldehyde tanning; Described artificial valve's 6 overall structures with from body aortic valve similar, the opposite shape of curve shape and aortic sinus, the blood flow that the space of generation can guarantee arteria coronaria is blocked not, and can guarantee the physiological hemodynamic effect of aortic root; Described rustless steel riveting 4 matches with carrying the vertical external screw thread of rope through its inner female thread; Described artificial valve's 6 usefulness propylene lines are fixed in middle the combination on the edge horizontal component 2 with the mode of continuous stitching; Described support adopts Nitinol tinsel material.
During use, adopt following steps:
1. the vertical rustless steel riveting 4 of recyclable aortic valve stent is connected with carrying the Suo Dingduan external screw thread, in recyclable valve bracket operation preload sheath;
2. select the patient who is fit to the TAVI operation, under the generalized anesthetic state, the puncture femoral artery; Insert the arterial sheath pipe, through the arterial sheath pipe will contain add stiff guide wire multi-functional conduit through ventral aorta, thoracic aorta, cross aortic valve to left ventricle; Seal wire is delivered to left ventricle; Front end is looped naturally, removes multi-functional conduit and arterial sheath pipe, sets up track;
3. the delivery sheath that will contain the convergent divergent channel inner core is delivered under the aortic valve in the left ventricle along adding stiff guide wire; Extract convergent divergent channel and seal wire out, the preload sheath is connected with delivery sheath, be pushed into recyclable valve bracket in the delivery sheath forward; Continue to be pushed into forward the sheath mouth of pipe, discharge in location, aortic valvular ring place;
4. the location situation of imaging examination valve bracket is undesirable as finding the position, adjustable position, and when waiting to adjust to ideal position, rope is carried in reverse rotation, discharges valve bracket, as finding the support displacement, can reclaim valve bracket through the sheath pipe.
5. withdraw from the sheath pipe, sew up the vascular puncture mouth, operation is accomplished.
Claims (4)
1. implant the controllable type aortic valve stent through conduit for one kind; Comprise support and artificial valve (6) two parts; It is characterized in that; Described support is the cage modle RF, comprises cage portion (5), lower end aorta horizontal component (1), middle edge horizontal component (2) and the upper end lobe ring horizontal circle tapering part (3) of combining from the bottom to top; The center, top of described upper end lobe ring horizontal circle tapering part (3) is provided with rustless steel riveting (4); Combine on the edge horizontal component (2) in the middle of described artificial valve (6) is fixed in; Described artificial valve (6) overall structure with from body aortic valve similar, the opposite shape of curve shape and aortic sinus.
2. described support is according to claim 1 a kind of through conduit implantation controllable type aortic valve stent, it is characterized in that described rustless steel riveting (4) matches with carrying the vertical external screw thread of rope through its inner female thread.
3. described support is according to claim 1 a kind ofly implants the controllable type aortic valve stent through conduit, it is characterized in that, in the middle of described artificial valve (6) is fixed in the mode of continuous stitching with the propylene line on the combination edge horizontal component (2).
4. described support is according to claim 1 a kind of through conduit implantation controllable type aortic valve stent, it is characterized in that described support adopts Nitinol tinsel material.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN2011103667672A CN102512271A (en) | 2011-11-18 | 2011-11-18 | Transcatheter implantation controllable aortic valvular stent |
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| CN2011103667672A CN102512271A (en) | 2011-11-18 | 2011-11-18 | Transcatheter implantation controllable aortic valvular stent |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106344232A (en) * | 2015-07-14 | 2017-01-25 | 浦易（上海）生物技术有限公司 | Sustained release medicine bracket for nasal cavity, forming method and application thereof |
| CN107249482A (en) * | 2015-02-17 | 2017-10-13 | 美敦力瓦斯科尔勒公司 | Method for anchoring heart valve prosthesis in through conduit valve implant procedure |
| CN108703823A (en) * | 2018-07-27 | 2018-10-26 | 武汉开阖同立医疗科技有限公司 | A kind of insertion type Puffer-type sacculus aortic valve stent system |
| US11083484B2 (en) | 2016-07-03 | 2021-08-10 | Sinusafe Medical Ltd. | Medical device for treatment of a sinus and/or an ear and methods of use thereof |
| US11213308B2 (en) | 2015-01-08 | 2022-01-04 | Sinusafe Medical Ltd | Paranasal sinus medical device and uses thereof |
| CN116801837A (en) * | 2020-12-14 | 2023-09-22 | 威尔沙血管公司 | Systems and methods for heart valve repair |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
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| US11213308B2 (en) | 2015-01-08 | 2022-01-04 | Sinusafe Medical Ltd | Paranasal sinus medical device and uses thereof |
| US11925371B2 (en) | 2015-01-08 | 2024-03-12 | Sinusafe Medical Ltd | Paranasal sinus medical device and uses thereof |
| CN107249482A (en) * | 2015-02-17 | 2017-10-13 | 美敦力瓦斯科尔勒公司 | Method for anchoring heart valve prosthesis in through conduit valve implant procedure |
| CN107249482B (en) * | 2015-02-17 | 2021-01-05 | 美敦力瓦斯科尔勒公司 | Method for anchoring a heart valve prosthesis in a transcatheter valve implantation procedure |
| CN106344232A (en) * | 2015-07-14 | 2017-01-25 | 浦易（上海）生物技术有限公司 | Sustained release medicine bracket for nasal cavity, forming method and application thereof |
| US11083484B2 (en) | 2016-07-03 | 2021-08-10 | Sinusafe Medical Ltd. | Medical device for treatment of a sinus and/or an ear and methods of use thereof |
| CN108703823A (en) * | 2018-07-27 | 2018-10-26 | 武汉开阖同立医疗科技有限公司 | A kind of insertion type Puffer-type sacculus aortic valve stent system |
| CN116801837A (en) * | 2020-12-14 | 2023-09-22 | 威尔沙血管公司 | Systems and methods for heart valve repair |
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Application publication date: 20120627 |