CN102895008A - Medical occluder and delivery system thereof - Google Patents

Abstract

The invention relates to the field of medical instruments, and in particular relates to a degradable medical occluder. The medical occluder comprises an occluder support (1), a film arranged on the occluder support (1), and a core shaft (2) fixed at a far end (5) of the occluder support, wherein the core shaft (2) penetrates through the occluder support (1), one end of the core shaft (2) is fixedly connected with the far end (5) of the occluder support, and a clamping structure matched with a near end (4) of the occluder support is arranged at the other end of the core shaft (2), so that when the occluder support (1) is unfolded, the near end (4) of the occluder support is clamped and locked with the other end of the core shaft (2); and the medical occluder is made of a degradable polymer. The medical occluder can be automatically degraded after entering human body, so that the hidden danger of side effects caused when the occluder is left in the human body is eliminated.

Description

Translated fromChinese

医用封堵器及其输送系统Medical occluder and its delivery system

技术领域technical field

本发明涉及医疗器械领域，尤其涉及一种可降解的医用封堵器及其输送系统。The invention relates to the field of medical devices, in particular to a degradable medical occluder and a delivery system thereof.

背景技术Background technique

先天性心脏病介入治疗已经很普遍了，封堵器是介入治疗的主要器械。目前国内外的很多公司都有产品上市，然而这些产品都是使用镍钛记忆合金丝编制，然后热定型；利用镍钛合金的超弹性，制备成自膨胀式封堵器。但是人体对器械的需求不是长期的，在3个月左右内膜就会被全部覆盖，此时，封堵器就是一个无用的异物，并且伴随有各种副作用，如镍离子溶出、破坏人体组织等。Interventional treatment of congenital heart disease has become very common, and occluder is the main instrument of interventional treatment. At present, many companies at home and abroad have products on the market, but these products are made of nickel-titanium memory alloy wire, and then heat-set; the superelasticity of nickel-titanium alloy is used to prepare a self-expanding occluder. However, the human body’s demand for devices is not long-term. The intima will be completely covered in about 3 months. At this time, the occluder is a useless foreign body, and it is accompanied by various side effects, such as the dissolution of nickel ions and the destruction of human tissues. wait.

最理想的封堵器应该是满足封堵作用的同时，在病变治愈后封堵器能够自行降解。但是除了镍钛合金，目前还找不到合适的超弹性材料，更不用说可降解的超弹性材料。The ideal occluder should meet the occlusion function and at the same time, the occluder can degrade by itself after the lesion is cured. But apart from nickel-titanium alloys, there is currently no suitable superelastic material, let alone a degradable superelastic material.

发明内容Contents of the invention

（一）要解决的技术问题(1) Technical problems to be solved

本发明的目的在于提供一种可降解的封堵器，用以解决封堵器在病变治愈后不能自行降解的问题。The purpose of the present invention is to provide a degradable occluder to solve the problem that the occluder cannot degrade automatically after the lesion is cured.

（二）技术方案(2) Technical solutions

本发明技术方案如下：Technical scheme of the present invention is as follows:

一种医用封堵器，包括封堵器支架、设置在所述封堵器支架上的膜、以及固定于封堵器支架远端的心轴；其特征在于：所述心轴穿过所述封堵器支架，所述心轴一端与封堵器支架远端固定连接，另一端设置有与封堵器支架近端相配合的卡合结构，使封堵器支架在展开时所述封堵器支架近端与所述心轴另一端卡合锁定，所述医用封堵器由可降解聚合物制成。A medical occluder, comprising a occluder bracket, a membrane arranged on the occluder bracket, and a mandrel fixed to the distal end of the occluder bracket; it is characterized in that: the mandrel passes through the The occluder bracket, one end of the mandrel is fixedly connected to the distal end of the occluder bracket, and the other end is provided with an engaging structure matched with the proximal end of the occluder bracket, so that when the occluder bracket is deployed, the occluder bracket The proximal end of the device bracket is engaged and locked with the other end of the mandrel, and the medical occluder is made of degradable polymer.

优选的，所述心轴另一端设置有卡合凸起，所述封堵器支架近端设置有与所述卡合凸起相匹配的卡槽。Preferably, the other end of the mandrel is provided with an engaging protrusion, and the proximal end of the occluder bracket is provided with an engaging groove matching the engaging protrusion.

优选的，所述封堵器支架近端设置有卡合凸起，所述心轴另一端设置有与所述卡合凸起相匹配的卡槽。Preferably, an engaging protrusion is provided at the proximal end of the occluder bracket, and an engaging groove matching the engaging protrusion is provided at the other end of the mandrel.

优选的，所述支架腰为可伸缩结构。Preferably, the support waist is a stretchable structure.

优选的，位于所述封堵器支架远端与所述支架腰之间的上盘面，以及位于所述封堵器支架近端与所述支架腰之间的下盘面上均开设有豁口，封堵器支架在展开时，所述上盘面和下盘面在所述豁口处弯折变形。Preferably, gaps are provided on the upper panel between the distal end of the occluder bracket and the waist of the bracket, and on the lower panel between the proximal end of the bracket of the occluder and the waist of the bracket. When the occluder bracket is unfolded, the upper and lower panels are bent and deformed at the gap.

优选的，位于所述封堵器支架远端与所述支架腰之间的上盘面，以及位于所述封堵器支架近端与所述支架腰之间的下盘面均由至少两段活动串联的支架条组成，封堵器支架在展开时，所述上盘面和下盘面在所述支架条的串联连接处弯折变形。Preferably, the upper panel between the distal end of the occluder bracket and the waist of the bracket, and the lower panel between the proximal end of the bracket of the occluder and the waist of the bracket are connected in series by at least two sections When the occluder bracket is deployed, the upper and lower panels are bent and deformed at the series connection of the bracket bars.

所述的医用封堵器的输送系统，包括内推送杆，所述内推送杆外套有可相对其轴向运动的外推送管，所述外推送管外套有可相对其轴向运动的外管鞘，外推送管与封堵器支架近端活动连接。The delivery system of the medical occluder includes an inner push rod, the inner push rod is covered with an outer push tube that can move axially relative to it, and the outer push tube is covered with an outer tube that can move axially relative to it The sheath, the outer pushing tube is flexibly connected with the proximal end of the occluder support.

优选的，所述内推送杆与心轴端连接头匹配形成轴向方向的连接，横向方向没有或只有部分连接。Preferably, the inner push rod is matched with the connecting head of the mandrel end to form a connection in the axial direction, and there is no or only partial connection in the transverse direction.

优选的，所述内推送杆和外推送管之间设置有可相对于内推送杆和外推送管轴向运动的内推送杆套管。Preferably, an inner push rod sleeve that can move axially relative to the inner push rod and the outer push tube is arranged between the inner push rod and the outer push tube.

优选的，所述输送系统还包括手柄，所述手柄用于控制内推送杆相对外推送管以及外推送管相对于外管鞘的运动。Preferably, the delivery system further includes a handle, and the handle is used to control the movement of the inner pushing rod relative to the outer pushing tube and the outer pushing tube relative to the outer tube sheath.

（三）有益效果(3) Beneficial effects

本发明提供的医用封堵器通过在心轴和封堵器支架之间设置相配合的卡和结构，摆脱了传统封堵器必须使用记忆合金或超弹性合金的限制；由于使用的是可降解聚合物材质，本发明提供的医用封堵器在进入人体后能够自行降解，消除了封堵器残留在人体内会造成的副作用的隐患。The medical occluder provided by the present invention breaks away from the restriction that traditional occluders must use memory alloys or superelastic alloys by providing a matching card and structure between the mandrel and the occluder bracket; Material, the medical occluder provided by the invention can degrade automatically after entering the human body, eliminating the hidden danger of side effects caused by the occluder remaining in the human body.

附图说明Description of drawings

图1是本发明实施例1中封堵器支架变形前示意图；Fig. 1 is a schematic diagram of the occluder bracket before deformation in Example 1 of the present invention;

图2是本发明实施例1中封堵器示意图；Fig. 2 is a schematic diagram of the occluder in Embodiment 1 of the present invention;

图3是本发明实施例2中针对PDA设计的封堵器示意图；Fig. 3 is the schematic diagram of the occluder designed for PDA in the embodiment of the present invention 2;

图4是本发明实施例2中针对ASD设计的封堵器示意图；4 is a schematic diagram of an occluder designed for ASD in Embodiment 2 of the present invention;

图5是本发明实施例3中输送系统的示意图。Fig. 5 is a schematic diagram of the delivery system in Embodiment 3 of the present invention.

图中：1：封堵器支架；2：心轴；3：支架腰；4：封堵器支架近端；5：封堵器支架远端；6：上盘面；7：下盘面；8：豁口；9：心轴端连接头；10：内推送杆；11：内推送杆端连接头；12：内推送杆套管；13：外推送管。In the figure: 1: occluder support; 2: mandrel; 3: support waist; 4: proximal end of occluder support; 5: distal end of occluder support; 6: upper plate; 7: lower plate; 8: Gap; 9: mandrel end connector; 10: inner push rod; 11: inner push rod end connector; 12: inner push rod sleeve; 13: outer push tube.

具体实施方式Detailed ways

下面结合附图和实施例，对本发明的具体实施方式做进一步描述。The specific implementation manner of the present invention will be further described below in conjunction with the drawings and embodiments.

实施例1Example 1

如图2所示的一种针对VSD（Ventricular septal defect，心室隔膜缺陷）设计的医用封堵器：包括封堵器支架1、设置在封堵器支架1上的膜、以及固定于封堵器支架一端的心轴2，封堵器支架此端称为封堵器支架远端5，相应的，另一端称为封堵器支架近端4；心轴2穿过封堵器支架1，心轴2一端与封堵器支架远端5固定连接，另一端设置有与封堵器支架近端4相配合的卡合结构，使封堵器支架1在展开时封堵器支架近端4与心轴2另一端卡合锁定，医用封堵器由可降解聚合物制成。可降解聚合物可以为丝素蛋白、PLA（聚乳酸）、PGA（聚乙醇酸）、PGLA（聚乙丙交酯）或复合材料等。A medical occluder designed for VSD (Ventricular septal defect, ventricular septal defect) as shown in Fig. The mandrel 2 at one end of the bracket, this end of the occluder support is called the occluder support distal end 5, and correspondingly, the other end is called the occluder support proximal end 4; the mandrel 2 passes through the occluder support 1, and the heart One end of the shaft 2 is fixedly connected to the distal end 5 of the occluder bracket, and the other end is provided with an engaging structure that matches the proximal end 4 of the occluder bracket, so that when the occluder bracket 1 is deployed, the proximal end 4 of the occluder bracket is in contact with the The other end of the mandrel 2 is engaged and locked, and the medical occluder is made of a degradable polymer. The degradable polymer can be silk fibroin, PLA (polylactic acid), PGA (polyglycolic acid), PGLA (polyglycolide) or composite materials.

这样的结构设计，摆脱了传统封堵器必须使用记忆合金或超弹性合金的限制；由于使用的是可降解聚合物材质，本发明提供的医用封堵器在进入人体后能够自行降解，消除了封堵器残留在人体内会造成的副作用的隐患。Such a structural design breaks away from the restriction that traditional occluders must use memory alloys or superelastic alloys; as the material used is degradable polymer, the medical occluder provided by the invention can degrade itself after entering the human body, eliminating the need for The hidden danger of side effects caused by the occluder remaining in the human body.

进一步的，心轴2另一端设置有卡合凸起，封堵器支架近端4设置有与卡合凸起相匹配的卡槽。或者封堵器支架近端4设置有卡合凸起，心轴2另一端设置有与卡合凸起相匹配的卡槽。目的是为了保证封堵器支架近端4到达心轴2上相应位置时能够得到有力的束缚，确保封堵器支架1展开后无法自由回弹而保持封堵状态。Further, the other end of the mandrel 2 is provided with an engaging protrusion, and the proximal end 4 of the occluder support is provided with an engaging groove matching the engaging protrusion. Alternatively, the proximal end 4 of the occluder bracket is provided with an engaging protrusion, and the other end of the mandrel 2 is provided with an engaging groove matching the engaging protrusion. The purpose is to ensure that the proximal end 4 of the occluder stent can be strongly restrained when it reaches the corresponding position on the mandrel 2 , and ensure that the occluder stent 1 cannot rebound freely after deployment and maintain the occluded state.

进一步的，支架腰3为可伸缩结构，其长度和直径可以根据需要而定，目的是为了保证封堵器能够扩张到治疗需要的长度和直径，在本实施例中采用的是菱形结构。Further, the stent waist 3 is a stretchable structure, and its length and diameter can be determined according to the needs. The purpose is to ensure that the occluder can be expanded to the length and diameter required for treatment. In this embodiment, a rhombus structure is adopted.

进一步的，位于封堵器支架远端5与支架腰3之间的上盘面6，以及位于封堵器支架近端4与支架腰3之间的下盘面7上均开设有豁口8，豁口8用于方便定型，变形后形成上盘面6和下盘面7的折点。或者位于封堵器支架远端5与支架腰3之间的上盘面6，以及位于封堵器支架近端4与支架腰3之间的下盘面7均由至少两段活动串联的支架条组成，封堵器支架1在展开时，上盘面6和下盘面7在支架条的串联连接处弯折变形，方便定型。Further, gaps 8 are provided on the upper panel 6 between the distal end 5 of the occluder bracket and the waist 3 of the bracket, and on the lower panel 7 between the proximal end 4 of the bracket of the occluder bracket and the waist 3 of the bracket. It is used for shaping conveniently, and the inflection points of the upper disk surface 6 and the lower disk surface 7 are formed after deformation. Alternatively, the upper panel 6 located between the distal end 5 of the occluder bracket and the waist 3 of the bracket, and the lower panel 7 located between the proximal end 4 of the bracket of the occluder bracket and the waist 3 of the bracket are composed of at least two sections of bracket strips that are movable in series , when the occluder bracket 1 is unfolded, the upper panel 6 and the lower panel 7 are bent and deformed at the series connection of the bracket bars, which is convenient for shaping.

实施例2Example 2

一种针对PDA（Patent ductus arteriosus，动脉导管未闭）设计的封堵器，如图3所示；一种针对ASD（Atrial septal defect，心房隔膜缺陷）设计的封堵器，如图4所示。它们与实施例1仅是外观上有所区别：针对PDA和针对ASD设计的封堵器的下盘面相对上盘面较扁。An occluder designed for PDA (Patent ductus arteriosus, patent ductus arteriosus), as shown in Figure 3; an occluder designed for ASD (Atrial septal defect, atrial septal defect), as shown in Figure 4 . They differ from Embodiment 1 only in appearance: the lower disc surface of the occluder designed for PDA and ASD is flatter than the upper disc surface.

实施例3Example 3

如图5所示的医用封堵器的输送系统，包括内推送杆10，内推送杆10外套有可相对其轴向运动的外推送管13，外推送管13外套有可相对其轴向运动的外管鞘，外推送管13通过绳索与封堵器支架近端4连接，也可以通过连接槽连接，主要是为了实现展开和回收封堵器；外管鞘主要用于保护封堵器。The delivery system of the medical occluder as shown in Figure 5 includes aninner push rod 10, theinner push rod 10 is covered with anouter push tube 13 that can move axially relative to it, and theouter push tube 13 is covered with a push tube that can move axially relative to it. The outer sheath, theouter pusher tube 13 is connected to the proximal end 4 of the occluder support through a rope, and can also be connected through a connecting groove, mainly to realize deployment and recovery of the occluder; the outer sheath is mainly used to protect the occluder.

进一步的，心轴2另一端具有心轴端连接头9；内推送杆10与心轴端连接头9匹配形成轴向方向的连接，横向方向没有或只有部分连接，目的是方便封堵器的释放。Further, the other end of the mandrel 2 has amandrel end connector 9; theinner push rod 10 is matched with themandrel end connector 9 to form a connection in the axial direction, and there is no or only part of the connection in the transverse direction, the purpose is to facilitate the occluder freed.

进一步的，内推送杆10和外推送管13之间设置有可相对于内推送杆10和外推送管13轴向运动的内推送杆套管12，心轴端连接头9与内推送杆端连接头11连接后可以收缩回到内推送杆套管12内，形成横向束缚，这时内推送杆10和封堵器牢固连接，释放时，将心轴端连接头9与内推送杆端连接头11推出内推送杆套管12，解除横向束缚，控制内推送杆10，心轴端连接头9就可以脱离内推送杆端连接头11。Further, an innerpush rod sleeve 12 that can move axially relative to theinner push rod 10 and theouter push tube 13 is provided between theinner push rod 10 and theouter push tube 13, and themandrel end connector 9 is connected to the inner push rod end. After theconnection head 11 is connected, it can shrink back into the innerpush rod sleeve 12 to form a lateral restraint. At this time, theinner push rod 10 and the occluder are firmly connected. When releasing, connect themandrel end connector 9 to the inner push rod end Thehead 11 pushes out the innerpush rod sleeve 12, releases the lateral restraint, controls theinner push rod 10, and themandrel end connector 9 can break away from the inner pushrod end connector 11.

进一步的，输送系统还包括手柄，手柄用于控制内推送杆10、相对外推送管13以及外推送管13相对于外管鞘的运动。。Further, the delivery system further includes a handle, which is used to control the movement of theinner pushing rod 10, the relativeouter pushing tube 13, and theouter pushing tube 13 relative to the outer tube sheath. .

实际操作中与扩张管配合使用，到达病变后去掉扩张管，首先通过手柄控制内推送杆10，从而控制封堵器，封堵器从管状变成伞状，封堵病变，同时外推送管13与封堵器断开连接，通过手柄控制内推送杆套管12，解除横向束缚，使内推送杆10和封堵器分离，封堵器完全释放。In actual operation, it is used in conjunction with the expansion tube. After reaching the lesion, the expansion tube is removed. First, theinner push rod 10 is controlled by the handle to control the occluder. Disconnect from the occluder, control the innerpush rod sleeve 12 through the handle, release the lateral restraint, separate theinner push rod 10 from the occluder, and completely release the occluder.

以上实施方式仅用于说明本发明，而并非对本发明的限制，有关技术领域的普通技术人员，在不脱离本发明的精神和范围的情况下，还可以做出各种变化和变型，因此所有等同的技术方案也属于本发明的保护范畴。The above embodiments are only used to illustrate the present invention, but not to limit the present invention. Those of ordinary skill in the relevant technical field can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, all Equivalent technical solutions also belong to the protection category of the present invention.

Claims (10)

1. medical stopper, the axle (2) that comprises stopper support (1), is arranged on the film on the described stopper support (1) and is fixed in stopper rack far end (5); It is characterized in that: described axle (2) is passed described stopper support (1), described axle (2) one ends are fixedly connected with stopper rack far end (5), the other end is provided with the snap-in structure that matches with stopper mount proximal end (4), make stopper support (1) upon deployment described stopper mount proximal end (4) and described axle (2) other end snap lock, described medical stopper is made by degradable polymer.

2. described medical stopper according to claim 1, it is characterized in that: described axle (2) other end is provided with snap fit tabs, and described stopper mount proximal end (4) is provided with the draw-in groove that is complementary with described snap fit tabs.

3. described medical stopper according to claim 1, it is characterized in that: described stopper mount proximal end (4) is provided with snap fit tabs, and described axle (2) other end is provided with the draw-in groove that is complementary with described snap fit tabs.

4. according to claim 2 or 3 described medical stoppers, it is characterized in that: described support waist (3) is Collapsible structure.

5. described medical stopper according to claim 3, it is characterized in that: be positioned at the upper disk surface (6) between described stopper rack far end (5) and the described support waist (3), and be positioned on the lower card (7) between described stopper mount proximal end (4) and the described support waist (3) and all offer gap (8), stopper support (1) upon deployment, described upper disk surface (6) and lower card (7) are located bending distortion at described gap (8).

6. described medical stopper according to claim 3, it is characterized in that: be positioned at the upper disk surface (6) between described stopper rack far end (5) and the described support waist (3), and be positioned at lower card (7) between described stopper mount proximal end (4) and the described support waist (3) by at least two sections movable support bars compositions of connect, stopper support (1) upon deployment, described upper disk surface (6) and lower card (7) are in the bending distortion of the place of being connected in series of described support bar.

7. the induction system of a medical stopper according to claim 1, comprise interior push rod (10), described interior push rod (10) overcoat has the outer propelling movement pipe (13) of relatively its axially-movable, described outer propelling movement pipe (13) overcoat has the outer tube sheath of relatively its axially-movable, and described outer propelling movement pipe (13) is flexibly connected with described stopper mount proximal end (4).

8. induction system according to claim 7, it is characterized in that: described axle (2) other end has axle end union joint (9); Described interior push rod (10) forms being connected of axial direction with axle end union joint (9) coupling.

9. induction system according to claim 8, it is characterized in that: being provided with between described interior push rod (10) and the outer propelling movement pipe (13) can be with respect to the interior push rod sleeve pipe (12) of interior push rod (10) and outer propelling movement pipe (13) axially-movable.

10. the described induction system of any one in 9 according to claim 7, it is characterized in that: described induction system also comprises the handle that is connected with interior push rod (10), outer propelling movement pipe (13), and push rod (10) was relatively outer in described handle was used for controlling pushes pipe (13) and push pipe (13) outward with respect to the motion of outer tube sheath.

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