CN205126332U - Damaged plugging device of degradable heart - Google Patents
Damaged plugging device of degradable heart Download PDFInfo
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- CN205126332U CN205126332U CN201520778130.8U CN201520778130U CN205126332U CN 205126332 U CN205126332 U CN 205126332U CN 201520778130 U CN201520778130 U CN 201520778130U CN 205126332 U CN205126332 U CN 205126332U
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Abstract
本实用新型涉及医疗器械技术领域,尤其涉及一种心脏缺损封堵器,具体的是一种生物可吸收心脏缺损封堵器。该心脏缺损封堵器由生物可吸收材料制备,封堵器包括支撑骨架、绒毛伞片、封堵膜组成。分为支撑骨架、绒毛伞片、封堵膜、腰部以及连接头五部分组成。所述腰部为圆弧状的绒毛凹陷部位。本实用新型心脏缺损封堵器在完成封堵缺损手术后,不会即时完全分隔缺损处,而是随着封堵器表面内膜化,患处缓慢被修复,减少了患者由于肺动脉高压,造成顽固性右心衰竭甚至猝死的可能性,而后封堵器会被人体吸收而不会长期留在人体内,避免了心律失常:包括房颤和传导阻滞等副作用,金属封堵器磨损心房游离壁将引起远期并发症。
The utility model relates to the technical field of medical devices, in particular to a heart defect occluder, in particular to a bioabsorbable heart defect occluder. The cardiac defect occluder is made of bioabsorbable materials, and the occluder includes a support frame, a velvet umbrella, and an occluder membrane. It is composed of five parts: supporting frame, fluff umbrella, sealing membrane, waist and connecting head. The waist is an arc-shaped recessed part of fluff. The heart defect occluder of the utility model does not immediately and completely separate the defect after the defect occlusion operation is completed, but as the surface of the occluder becomes endothelial, the affected part is slowly repaired, which reduces the patient's stubbornness caused by pulmonary hypertension. The possibility of acute right heart failure or even sudden death, and then the occluder will be absorbed by the human body and will not stay in the human body for a long time, avoiding arrhythmia: including side effects such as atrial fibrillation and conduction block, and the metal occluder wears the atrial free wall Long-term complications will result.
Description
技术领域 technical field
本实用新型涉及医疗器械技术领域,具体涉及一种生物可降解心脏缺损封堵器。 The utility model relates to the technical field of medical devices, in particular to a biodegradable heart defect occluder.
背景技术 Background technique
房间缺损(以下简称ASD)或室间缺损(VSD)属于一种先天性心脏病,其病变的机理是左右心室或心房之间的间隔未能正常闭合。使血液能在房间或室间流动。由于左心房的压力高于右心房,所以左心房的部分血液流入右心房,造成体循环血流量减少,而肺循环相关器官发生病变。目前治疗心脏隔膜缺损的方法大多是介入治疗,即通过导管或导丝经过股动脉或颈静脉将封堵器送到患者心脏病灶处进行封堵,完成治疗。 Atrial defect (hereinafter referred to as ASD) or ventricular defect (VSD) is a kind of congenital heart disease. The mechanism of its lesion is that the septum between the left and right ventricles or atria fails to close normally. To enable blood to flow in a room or room. Since the pressure of the left atrium is higher than that of the right atrium, part of the blood from the left atrium flows into the right atrium, resulting in a decrease in blood flow in the systemic circulation and lesions in related organs of the pulmonary circulation. At present, most of the methods for the treatment of cardiac septal defect are interventional therapy, that is, the occluder is sent to the patient's cardiac focus through a catheter or guide wire through the femoral artery or jugular vein to block and complete the treatment.
目前市场化的封堵器结构大多是金属不可降解的金属丝线编织而成的网状或金属弹簧支架。已经证实有良好的前期中期疗效,但是长期的并发症不可忽略,如封堵器的加持力影响心脏自然跳动,造成心律不齐,传导阻滞,金属镍过敏等无长期的随访资料。封堵器植入人体后,其表面会完全内皮化,自身的组织会达到一个很好的封堵效果,而原来的封堵器完全没必要继续留在体内。 Most of the currently marketed occluder structures are mesh or metal spring stents braided by non-degradable metal wires. It has been proven to have a good early and mid-term curative effect, but long-term complications cannot be ignored, such as the force of the occluder affecting the natural beating of the heart, causing arrhythmia, conduction block, metal nickel allergy, etc. There is no long-term follow-up data. After the occluder is implanted into the human body, its surface will be completely endothelialized, and its own tissues will achieve a good occlusion effect, and the original occluder does not need to remain in the body at all.
目前市场上还未出现完全可降解封堵器,均不能在其完成治疗后被人体吸收,有可能在远期造成并发症。 At present, there is no fully degradable occluder on the market, and none of them can be absorbed by the human body after the treatment is completed, which may cause complications in the long run.
目前市场上的封堵器都是在植入之后即时将病灶完全封堵,可能造成肺动脉高压,造成顽固性右心衰竭甚至猝死。 The occluders currently on the market completely block the lesion immediately after implantation, which may cause pulmonary hypertension, intractable right heart failure or even sudden death.
本实用新型提供了一种缓慢封堵缺损患处的可吸收心脏缺损封堵器。 The utility model provides an absorbable heart defect occluder for slowly occluding the affected part of the defect.
实用新型内容 Utility model content
(一)要解决的技术问题 (1) Technical problems to be solved
本实用新型要解决的技术问题是解决心脏缺损封堵器植入人体内,由于瞬间完全封堵可能使肺动脉压升高,导致顽固性右心衰竭甚至猝死;且金属的封堵器植入人体后,引起一些远期并发症和副作用,且操作简单。 The technical problem to be solved by the utility model is to solve the problem that when the heart defect occluder is implanted into the human body, the pulmonary artery pressure may increase due to instantaneous complete occlusion, resulting in intractable right heart failure or even sudden death; and the metal occluder is implanted into the human body Afterwards, some long-term complications and side effects are caused, and the operation is simple.
(二)技术方案 (2) Technical solution
为了解决其技术问题提供了一种心脏缺损封堵器,该缺损封堵器包括支撑骨架、绒毛伞片、封堵膜、连接头,所述支撑骨架为圆柱体状,所述绒毛伞片的绒毛嵌入支撑骨架中,所述腰部为有一定幅度的凹陷部位。 In order to solve the technical problem, a heart defect occluder is provided, which includes a support frame, a villi umbrella, an occlusion membrane, and a connector, the support frame is cylindrical, and the villi umbrella The fluff is embedded in the support frame, and the waist is a concave part with a certain range.
其中,所述支撑骨架左右两端各打了几圈圆形小孔,绒毛植入其中,所述两片封堵膜分别设置在左右绒毛伞片上或分别用封堵膜将两伞片均包裹起来。 Wherein, the left and right ends of the supporting frame are each punched with a few circles of small circular holes, the fluff is implanted in it, and the two sealing films are respectively arranged on the left and right fluff umbrella pieces or are respectively wrapped with the sealing membranes. stand up.
其中,所述支撑骨架、绒毛伞片、封堵膜、连接头均采用生物可降解聚合物材料制备。 Wherein, the support frame, the fluff umbrella, the sealing membrane and the connector are all made of biodegradable polymer materials.
其中,所述生物可降解聚合物材料为外消旋聚乳酸、左旋聚乳酸、聚己内酯、聚乙交酯、聚丙交酯乙交酯或聚左旋丙交酯乙交酯三亚甲基碳酸酯共聚物。 Wherein, the biodegradable polymer material is racemic polylactic acid, L-polylactic acid, polycaprolactone, polyglycolide, polylactide-glycolide or poly-L-lactide-glycolide trimethylene carbonate ester copolymer.
其中,所述腰部是支撑骨架植入绒毛形成的,其凹陷部位形状为圆弧形或矩形或三角形或其他形状。 Wherein, the waist is formed by implanting the supporting skeleton with villi, and the shape of the concave part is arc-shaped, rectangular, triangular or other shapes.
其中,所述封堵膜采用缝合线或者激光焊接技术固定于绒毛和支撑骨架上。 Wherein, the occlusion membrane is fixed on the villi and the supporting frame by suture or laser welding technology.
其中,所述腰部绒毛与缝合线采用生物可降解聚合物材料制备。 Wherein, the waist fluff and sutures are made of biodegradable polymer materials.
其中,所述凹陷的数量为1个或多个。 Wherein, the number of said depressions is 1 or more.
(三)有益效果 (3) Beneficial effects
本发明的有益效果是:所用封堵膜为具有一定的透过液体的性能,能保证心脏左右两边压差不会太高,腰部的绒毛可以增加器械与缺损部位的摩擦力加少了封堵器位移的可能性,封堵膜设置在左右绒毛伞片的中间,使封堵膜能完全覆盖缺损部位。绒毛伞片有很好的弹性,能够在封堵不成功后完全撤回,本实用新型心脏缺损封堵器均采用生物可降解聚合物材料制备,在病灶内皮化后封堵器会完全降解,避免了不可降解材料引起的副反应。 The beneficial effects of the present invention are: the sealing membrane used has a certain liquid-permeable performance, which can ensure that the pressure difference between the left and right sides of the heart will not be too high, and the fluff on the waist can increase the friction between the instrument and the defect and reduce the sealing In order to avoid the possibility of device displacement, the sealing membrane is set in the middle of the left and right villi umbrellas, so that the sealing membrane can completely cover the defect. The fluffy umbrella has good elasticity and can be completely withdrawn after the blockage is unsuccessful. The heart defect occluder of the present invention is made of biodegradable polymer materials. After the lesion is endothelialized, the occluder will be completely degraded to avoid side effects caused by non-degradable materials.
附图说明 Description of drawings
附图1是本实用新型实施例可降解心脏缺损封堵器打开时的外观结构示意图; Accompanying drawing 1 is the appearance structure diagram when the degradable heart defect occluder of the embodiment of the utility model is opened;
附图2是本实用新型实施例可降解心脏封堵器支架俯视以及左视图; Accompanying drawing 2 is the top view and the left side view of the degradable cardiac occluder bracket of the embodiment of the present invention;
附图3是本实用新型实施例可降解心脏封堵器的A-A剖面图; Accompanying drawing 3 is the A-A sectional view of the degradable heart occluder of the utility model embodiment;
附图4是本实用新型实施例可降解心脏封堵器的B-B剖面图。 Accompanying drawing 4 is the B-B sectional view of the degradable cardiac occluder of the embodiment of the utility model.
图中:1:支撑骨架;2:绒毛伞片;3:封堵膜;4:腰部;5:连接头。 In the figure: 1: supporting frame; 2: fluff umbrella piece; 3: sealing membrane; 4: waist; 5: connecting head.
具体实施方式 detailed description
下面结合附图和实施例对本实用新型的具体实施方式作进一步详细描述。以下实施例用于说明本实用新型,但不用来限制本实用新型的范围。 The specific implementation of the present utility model will be further described in detail below in conjunction with the accompanying drawings and examples. The following examples are used to illustrate the utility model, but not to limit the scope of the utility model.
如图1-4所示,本新型的实例提供的心脏封堵器,该心脏缺损封堵器包括支撑骨架(1)、绒毛伞片(2)、封堵膜(3)、腰部(4)、连接头(5),所述支撑骨架(1)为柱状体,所述绒毛伞片(2)的绒毛嵌入支撑骨架(1)中,所述腰部(4)为有一定幅度的凹陷A-A,B-B。 As shown in Figure 1-4, the heart occluder provided by the example of the present invention, the heart defect occluder includes a supporting frame (1), a villi umbrella (2), a occluding membrane (3), a waist (4) . Connecting head (5), the support frame (1) is a columnar body, the fluff of the fluff umbrella (2) is embedded in the support frame (1), and the waist (4) is a depression A-A with a certain range, B-B.
所述支撑骨架(1)左右两端各打了几圈圆形小孔,绒毛植入其中,所述两片封堵膜(3)分别设置在左右绒毛伞片(2)上或者分别用封堵膜(3)将两伞片均包裹起来。 The left and right ends of the support frame (1) are punched with a few circles of small circular holes, and the fluff is implanted in it, and the two sealing films (3) are respectively arranged on the left and right fluff umbrella pieces (2) or sealed with Blocking film (3) all wraps up two umbrella slices.
本实用新型封堵器绒毛伞片(2)与封堵膜(3)可顺利的撑开,同时也能实现绒毛伞片(2)与封堵膜(3)的收回。 The velvet umbrella (2) and the sealing film (3) of the occluder of the utility model can be smoothly opened, and at the same time, the retraction of the velvet umbrella (2) and the sealing film (3) can also be realized.
所述封堵膜(3)采用缝合线或激光焊接固定在绒毛伞片(2)上,并固定于支撑骨架(1)上。 The blocking membrane (3) is fixed on the villi umbrella (2) by sutures or laser welding, and is fixed on the support frame (1).
所述连接头(5)为精工雕刻形成的螺纹与专用的输送的设备连接撑开或收回伞片。 The connecting head (5) is thread formed by precision carving and is connected with special conveying equipment to open or retract the umbrella piece.
所述支撑骨架(1)、绒毛伞片(2)、封堵膜(3)、腰部(4)、连接头(5)及缝合线均采用生物可降解聚合物材料制备。优选地,所述支撑骨架(1)、绒毛伞片(2)、封堵膜(3)、腰部(4)及连接头(5)由外消旋聚乳酸(PDLLA)、左旋聚乳酸(PLLA)、聚己内酯(PCL)、聚乙交酯(PGA)、聚丙交酯乙交酯(PGLA)或聚左旋丙交酯乙交酯三亚甲基碳酸酯共聚物(PTLGA)制备。 The support frame (1), fluff umbrella (2), occluding membrane (3), waist (4), connector (5) and sutures are all made of biodegradable polymer materials. Preferably, the supporting frame (1), fluff umbrella (2), occluding membrane (3), waist (4) and connector (5) are made of racemic polylactic acid (PDLLA), poly-L-lactic acid (PLLA) ), polycaprolactone (PCL), polyglycolide (PGA), polylactide-glycolide (PGLA) or poly-L-lactide-glycolide trimethylene carbonate copolymer (PTLGA).
腰部(4)设置为有绒毛的凹陷的圆弧状或三角形或矩形,凹陷部位可以为一个或几个,且本实用新型心脏缺损封堵器均采用生物可降解聚合物材料制备,这样封堵器在组织细胞在其外表面内膜化后,降解为小分子被人体吸收。 The waist (4) is set as a concave circular arc or triangle or rectangle with fluff, and there can be one or several concave parts, and the heart defect occluder of the present invention is made of biodegradable polymer materials, so that the occlusion After tissue cells intima on their outer surface, the organ is degraded into small molecules to be absorbed by the body.
所以本实用新型心脏缺损封堵器为绒毛伞片(2)固定在支撑骨架(1)左右两端上,腰部(4)为圆弧状的或其他形状的凹陷,所有所用的材料均能在封堵器完成其使命后,在人体内完全降解,避免了不可降解材料所带来的很多副作用。 Therefore, the heart defect occluder of the utility model is that the fluffy umbrella (2) is fixed on the left and right ends of the support frame (1), and the waist (4) is arc-shaped or concave in other shapes. After the occluder completes its mission, it will be completely degraded in the human body, avoiding many side effects caused by non-degradable materials.
以上所述仅是本实用新型的一种优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本实用新型技术原理的前提下,还可以做出若干改进和变型,这些改进和变型也应在本实用新型的保护范围内。 The above is only a preferred embodiment of the utility model, and it should be pointed out that for those of ordinary skill in the art, some improvements and modifications can be made without departing from the technical principle of the utility model. These improvements and modifications should also be within the protection scope of the present utility model.
Claims (8)
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201520778130.8U CN205126332U (en) | 2015-10-09 | 2015-10-09 | Damaged plugging device of degradable heart |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201520778130.8U CN205126332U (en) | 2015-10-09 | 2015-10-09 | Damaged plugging device of degradable heart |
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| CN205126332U true CN205126332U (en) | 2016-04-06 |
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| CN201520778130.8U Expired - Fee Related CN205126332U (en) | 2015-10-09 | 2015-10-09 | Damaged plugging device of degradable heart |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108420469A (en) * | 2018-03-16 | 2018-08-21 | 上海形状记忆合金材料有限公司 | A fully degradable occluder skeleton structure |
| CN108543231A (en) * | 2018-05-22 | 2018-09-18 | 北京大学口腔医学院 | A kind of degradable multispectral luminous implantation material |
| CN110432935A (en) * | 2019-08-01 | 2019-11-12 | 上海形状记忆合金材料有限公司 | Degradable plugging device and preparation method thereof |
-
2015
- 2015-10-09 CN CN201520778130.8U patent/CN205126332U/en not_active Expired - Fee Related
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108420469A (en) * | 2018-03-16 | 2018-08-21 | 上海形状记忆合金材料有限公司 | A fully degradable occluder skeleton structure |
| CN108543231A (en) * | 2018-05-22 | 2018-09-18 | 北京大学口腔医学院 | A kind of degradable multispectral luminous implantation material |
| CN108543231B (en) * | 2018-05-22 | 2024-04-12 | 北京大学口腔医学院 | Degradable multispectral luminous implant |
| CN110432935A (en) * | 2019-08-01 | 2019-11-12 | 上海形状记忆合金材料有限公司 | Degradable plugging device and preparation method thereof |
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