CN100508913C - Indirect artificial valva outside vein - Google Patents
Indirect artificial valva outside vein Download PDFInfo
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- CN100508913C CN100508913C CNB2006101546352A CN200610154635A CN100508913C CN 100508913 C CN100508913 C CN 100508913C CN B2006101546352 A CNB2006101546352 A CN B2006101546352A CN 200610154635 A CN200610154635 A CN 200610154635A CN 100508913 C CN100508913 C CN 100508913C
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Abstract
本发明公开了一种静脉外间接人造瓣膜。瓣膜上体和瓣膜下体通过两侧瓣膜轴连接;瓣膜上体与瓣膜下体相对面的两端分别设有血管壁远端压迫点和血管壁近端压迫点,血管壁远端压迫点能与静脉远端接触,血管壁近端压迫点能与静脉近端接触;瓣膜上体与瓣膜下体的血管壁近端压迫点均用固定缝线将瓣膜上体与瓣膜下体与静脉壁固定。当血流自静脉近端向静脉远端流动时,能使血管壁远端压迫点闭合;当血流自静脉远端向静脉近端流动时,能血管壁远端压迫点被血流冲开。该发明可保持静脉内血液选择性单向流动,具有生理瓣膜的功能;而且该装置放置在血管壁外,保持血管内膜的完整性,减小术后血管内血栓形成可能的风险。
The invention discloses an extravenous indirect artificial valve. The upper body of the valve and the lower body of the valve are connected by the valve shafts on both sides; the opposite ends of the upper body of the valve and the lower body of the valve are respectively provided with pressure points at the distal end of the blood vessel wall and pressure points at the proximal end of the blood vessel wall. Distal contact, the pressure point at the proximal end of the blood vessel wall can be in contact with the proximal end of the vein; the pressure points at the proximal end of the blood vessel wall of the upper valve body and the lower valve body are all fixed with fixed sutures to fix the upper valve body, the lower valve body, and the vein wall. When the blood flow flows from the proximal end of the vein to the distal end of the vein, it can close the compression point at the distal end of the vessel wall; when the blood flow flows from the distal end of the vein to the proximal end of the vein, the pressure point at the distal end of the energy vessel wall can be washed away . The invention can maintain the selective one-way flow of blood in the vein and has the function of a physiological valve; moreover, the device is placed outside the vessel wall to maintain the integrity of the vessel intima and reduce the possible risk of intravascular thrombosis after surgery.
Description
技术领域 technical field
本发明涉及一种医疗器械,特别是涉及用于治疗下肢深静脉功能不全的一种静脉外间接人造瓣膜。The invention relates to a medical device, in particular to an extravenous indirect artificial valve for treating deep venous insufficiency of lower limbs.
背景技术 Background technique
人体全身的血液循环中,下肢血液抵抗重力作用向心脏回流是整个血液循环的重要组成部分。下肢血液可以抵抗重力而顺利回流主要两个原因,一是小腿的肌肉进行交替的收缩和舒张,作为一个肌肉泵,将包裹与肌肉内的静脉血液挤向心脏;二是在整个下肢静脉中,一般每隔10~20厘米即有一个静脉瓣膜,防止血液的返流。而由于先天性瓣膜结构不良、血栓的堵塞机化或长期站立负重等其他一些原因,造成瓣膜关闭功能不全,此类疾病称为下肢深静脉功能不全,国内发病率高达8.8%,严重影响人们的日常生活和工作。但是目前,该类疾病以手术治疗为首选,但是各种治疗手段尚不能达到令人满意的疗效。In the blood circulation of the whole body of the human body, the return of blood from the lower limbs to the heart against gravity is an important part of the whole blood circulation. There are two main reasons why the blood of the lower limbs can resist gravity and return smoothly. One is that the muscles of the lower legs contract and relax alternately, acting as a muscle pump to squeeze the venous blood wrapped in the muscles to the heart; the other is that in the veins of the entire lower limbs, Generally, there is a venous valve every 10 to 20 centimeters to prevent the backflow of blood. However, due to other reasons such as congenital valvular poor structure, thrombus blockage or long-term standing weight bearing, valve closure is insufficient. This kind of disease is called deep venous insufficiency of the lower extremities. daily life and work. But at present, surgery is the first choice for this kind of disease, but various treatment methods have not yet achieved satisfactory results.
近年来,许多国外学者提出各自瓣膜替代物的设计。目前国外研究中的瓣膜替代物的种类主要有:(1)将静脉壁的全部或内膜部分向腔内翻转形成一个瓣膜样结构,但是术后可能发疤痕挛缩,造成静脉管径狭窄,甚至阻塞;(2)利用不锈钢、铂等,制造人工瓣膜,此类设计将人工植入物直接暴露于血液中,有血栓形成可能;(3)设计在管壁外规律性压迫静脉的装置,模拟静脉瓣膜功能。目前用腓肠肌肌襻压迫静脉,当人体下肢运动时,腓肠肌肌襻对静脉的压迫就模拟静脉瓣膜功能,而当静息状态下,腓肠肌肌襻就起不了瓣膜的作用。In recent years, many foreign scholars have proposed the design of their own valve substitutes. At present, the types of valve substitutes in foreign research mainly include: (1) Turn all or the intima of the vein wall to the cavity to form a valve-like structure, but scar contracture may occur after surgery, resulting in stenosis of the vein diameter, or even (2) Using stainless steel, platinum, etc. to manufacture artificial valves, such designs expose artificial implants directly to blood, which may cause thrombosis; (3) Design devices that regularly compress veins outside the tube wall, simulating Venous valve function. At present, the gastrocnemius muscle loop is used to compress the vein. When the lower limbs of the human body are in motion, the gastrocnemius muscle loop compresses the vein to simulate the function of the venous valve. However, in a resting state, the gastrocnemius muscle loop cannot function as a valve.
发明内容 Contents of the invention
为了解决上述技术问题,本发明的目的在于提供一种静脉外间接人造瓣膜,保持静脉内血液选择性单向流动的手术植入装置。In order to solve the above technical problems, the object of the present invention is to provide an extravenous indirect artificial valve, a surgical implant device for maintaining selective unidirectional flow of blood in the vein.
为了实现上述目发明所采用的技术方案是:The technical scheme adopted in order to realize the above-mentioned object invention is:
瓣膜上体和瓣膜下体通过两侧瓣膜轴连接;瓣膜上体与瓣膜下体相对面的两端分别设有血管壁远端压迫点和血管壁近端压迫点,血管壁远端压迫点能与静脉远端接触,血管壁近端压迫点能与静脉近端接触;瓣膜上体与瓣膜下体的血管壁近端压迫点均用固定缝线将瓣膜上体与瓣膜下体与静脉壁固定。The upper body of the valve and the lower body of the valve are connected by the valve shafts on both sides; the opposite ends of the upper body of the valve and the lower body of the valve are respectively provided with pressure points at the distal end of the blood vessel wall and pressure points at the proximal end of the blood vessel wall. Distal contact, the pressure point at the proximal end of the blood vessel wall can be in contact with the proximal end of the vein; the pressure points at the proximal end of the blood vessel wall of the upper valve body and the lower valve body are all fixed with fixed sutures to fix the upper valve body, the lower valve body, and the vein wall.
血管壁远端压迫点压迫面积小于血管壁近端压迫点压迫面积;血管壁远端压迫点压迫程度大于血管壁近端压迫点压迫程度;血管壁远端压迫点与瓣膜轴在血管轴向投影距离小于血管壁近端压迫点与瓣膜轴投影距离。The compression area of the distal compression point of the vessel wall is smaller than the compression area of the proximal compression point of the vessel wall; the compression degree of the compression point of the distal vessel wall is greater than that of the proximal compression point of the vessel wall; the projection of the compression point of the distal vessel wall and the valve axis in the axial direction of the vessel The distance is smaller than the projected distance between the compression point at the proximal end of the vessel wall and the valve axis.
所述的瓣膜上体和瓣膜下体材料为外层包覆膨化聚四氟乙烯(ePTFE)层的钛合金。The material of the valve upper body and the lower valve body is titanium alloy whose outer layer is coated with expanded polytetrafluoroethylene (ePTFE) layer.
本发明具有的有益效果是:该发明可保持静脉内血液选择性单向流动,具有生理瓣膜的功能;而且该装置放置在血管壁外,保持血管内膜的完整性,减小术后血管内血栓形成可能的风险。The beneficial effects of the invention are: the invention can maintain the selective one-way flow of blood in the vein, and has the function of a physiological valve; moreover, the device is placed outside the blood vessel wall to maintain the integrity of the intima of the blood vessel and reduce postoperative intravascular Possible risk of thrombosis.
附图说明 Description of drawings
图1是本发明的结构原理立体图;Fig. 1 is a perspective view of the structural principle of the present invention;
图2是本发明处于关闭状态下的结构示意图;Fig. 2 is a schematic structural view of the present invention in a closed state;
图3是图2中A-A线的剖面图;Fig. 3 is the sectional view of line A-A among Fig. 2;
图4是图2中B-B线的剖面图;Fig. 4 is the sectional view of B-B line among Fig. 2;
图5是本发明处于开放状态下的的结构示意图;Fig. 5 is a schematic structural view of the present invention in an open state;
图6是图5中C-C线的剖面图;Fig. 6 is the sectional view of C-C line among Fig. 5;
图7是图5中D-D线的剖面图。Fig. 7 is a sectional view taken along line D-D in Fig. 5 .
图中:1、瓣膜下体,2、瓣膜上体,3、瓣膜轴,4、血管壁远端压迫点,5、血管壁近端压迫点,6、静脉壁,7、血管内腔截面,8、固定缝线,9、静脉远端,10、静脉近端。In the figure: 1. Inferior body of the valve, 2. Upper body of the valve, 3. Valve axis, 4. Compression point at the distal end of the vessel wall, 5. Compression point at the proximal end of the vessel wall, 6. Vein wall, 7. Cross-section of the lumen of the vessel, 8 , fixed suture, 9, the distal end of the vein, 10, the proximal end of the vein.
具体实施方式 Detailed ways
如图1、图2所示,瓣膜上体2和瓣膜下体1通过两侧瓣膜轴3连接;瓣膜上体2与瓣膜下体1相对面的两端分别设有血管壁远端压迫点4和血管壁近端压迫点5,血管壁远端压迫点4能与静脉远端9接触,血管壁近端压迫点5能与静脉近端10接触;瓣膜上体2与瓣膜下体1的血管壁近端压迫点4均用固定缝线8将瓣膜上体2与瓣膜下体1与静脉壁6固定。As shown in Figures 1 and 2, the upper valve body 2 and the lower valve body 1 are connected by
血管壁远端压迫点4压迫面积小于血管壁近端压迫点5压迫面积;血管壁远端压迫点4压迫程度大于血管壁近端压迫点5压迫程度;血管壁远端压迫点4与瓣膜轴3在血管轴向投影距离小于血管壁近端压迫点5与瓣膜轴3投影距离。The compression area of
所述的瓣膜上体2和瓣膜下体1材料为外层包覆膨化聚四氟乙烯(ePTFE)层的钛合金。The material of the upper valve body 2 and the lower valve body 1 is a titanium alloy whose outer layer is coated with an expanded polytetrafluoroethylene (ePTFE) layer.
本发明的工作原理如下:The working principle of the present invention is as follows:
如图2、图3、图4所示,当血流自静脉近端10向静脉远端9流动时,所述的静脉壁6对血管壁近端压迫点5产生的力矩大于静脉壁6对血管壁远端压迫点4产生的力矩,血管壁远端压迫点4的压迫程度变大,导致静脉闭合,如图3所示,而血管壁近端压迫点5的压迫程度变大,如图4所示。从而该装置起到阻断的血液反流的作用。As shown in Fig. 2, Fig. 3 and Fig. 4, when the blood flows from the
如图5、图6、图7所示,当血流自静脉远端9向静脉近端10流动时,所述的静脉壁6对血管壁远端压迫点4产生的力矩大于静脉壁6对血管壁近端压迫点5产生的力矩,血管壁远端压迫点4的压迫程度变小,如图6所示,而血管壁近端压迫点5的压迫程度变大,但不至于压迫到静脉闭合的程度,如图7所示。从而,血液顺利通过,向心脏流动。As shown in Fig. 5, Fig. 6 and Fig. 7, when the blood flow flows from the distal end of the vein 9 to the proximal end of the
如图2所示,为防止静脉壁6在血管壁近端压迫点5处发生侧向位移,在该装置安置时用手术缝线将静脉壁6的外膜与瓣膜上体2与瓣膜下体1的膨化聚四氟乙烯层缝合固定缝线8。As shown in Figure 2, in order to prevent the lateral displacement of the
在手术过程中,外科医生游离一端股静脉,结扎离断该段股静脉上的侧支静脉,将瓣膜上体2与瓣膜下体1放置于该段股静脉管壁外,安置两侧的瓣膜轴3,再缝合固定缝线8,从而完成了安置静脉外间接人造瓣膜的主要手术过程。During the operation, the surgeon frees one end of the femoral vein, ligates and cuts off the collateral veins on the femoral vein, places the upper valve body 2 and the lower valve body 1 outside the wall of the femoral vein, and places the valve shafts on both sides. 3, suturing the
上述具体实施方式用来解释说明本发明,而不是对本发明进行限制,在本发明的精神和权利要求的保护范围内,对本发明作出的任何修改和改变,都落入本发明的保护范围。The above specific embodiments are used to explain the present invention, rather than to limit the present invention. Within the spirit of the present invention and the protection scope of the claims, any modification and change made to the present invention will fall into the protection scope of the present invention.
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Families Citing this family (9)
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JP2013521016A (en) | 2010-02-26 | 2013-06-10 | ボード オブ トラスティーズ オブ ザ レランド スタンフォード ジュニア ユニバーシティ | System and method for intraluminal valve generation |
US20120289987A1 (en) | 2011-04-20 | 2012-11-15 | The Board Of Trustees Of The Leland Stanford Junior University | Systems and methods for endoluminal valve creation |
WO2013119849A1 (en) | 2012-02-07 | 2013-08-15 | Intervene, Inc. | Systems and methods for endoluminal valve creation |
US9955990B2 (en) | 2013-01-10 | 2018-05-01 | Intervene, Inc. | Systems and methods for endoluminal valve creation |
WO2015048565A2 (en) | 2013-09-27 | 2015-04-02 | Intervene, Inc. | Visualization devices, systems, and methods for informing intravascular procedures on blood vessel valves |
US10188419B2 (en) | 2014-03-24 | 2019-01-29 | Intervene, Inc. | Visualization devices for use during percutaneous tissue dissection and associated systems and methods |
US10603018B2 (en) | 2014-12-16 | 2020-03-31 | Intervene, Inc. | Intravascular devices, systems, and methods for the controlled dissection of body lumens |
US10646247B2 (en) | 2016-04-01 | 2020-05-12 | Intervene, Inc. | Intraluminal tissue modifying systems and associated devices and methods |
EP4167867A1 (en) | 2020-06-23 | 2023-04-26 | Intervene, Inc. | Endovascular valve formation system with imaging capability |
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Non-Patent Citations (2)
Title |
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慢性下肢静脉功能不全的外科治疗进展及其疗效评价. 王俊,刘颖斌,彭淑牖.中国实用外科杂志,第25卷第12期. 2005 |
慢性下肢静脉功能不全的外科治疗进展及其疗效评价. 王俊,刘颖斌,彭淑牖.中国实用外科杂志,第25卷第12期. 2005 * |
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