WO2016138713A1 - Left ventricle volume reduction device - Google Patents

Left ventricle volume reduction device Download PDF

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Publication number
WO2016138713A1
WO2016138713A1 PCT/CN2015/084024 CN2015084024W WO2016138713A1 WO 2016138713 A1 WO2016138713 A1 WO 2016138713A1 CN 2015084024 W CN2015084024 W CN 2015084024W WO 2016138713 A1 WO2016138713 A1 WO 2016138713A1
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Prior art keywords
support frame
apex
left ventricle
support
left ventricular
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PCT/CN2015/084024
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French (fr)
Chinese (zh)
Inventor
王超
杨永森
陈娟
钱卫东
罗鹏
李博
蒲忠杰
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上海形状记忆合金材料有限公司
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Publication of WO2016138713A1 publication Critical patent/WO2016138713A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord

Definitions

  • the invention relates to a left ventricular volume reduction device.
  • Heart failure is the ultimate destination of most cardiovascular diseases and the leading cause of death, with nearly 23 million people worldwide suffering from the disease.
  • Parachute was the first percutaneous left ventricular reconstruction device based on catheter technology. The technology was first reported in 2007 and has been gradually developed abroad. It has accumulated hundreds of experiences and obtained European CE certification in 2011. It can effectively alleviate the clinical symptoms of patients with heart failure, improve heart function, and increase the five-year survival rate of patients with advanced heart failure from 30% to 80%. Currently, it has been applied in more than 500 cases in Europe and America.
  • Partial left ventriculectomy is a surgical procedure for the treatment of advanced dilated cardiomyopathy in recent years, first proposed by Brazilian physician Batista in 1996.
  • Left ventricular volume reduction surgery is also called “partial left ventricular resection” or “reserved left ventricular resection” in China, but left ventricular volume reduction surgery has higher heart failure, arrhythmia-related mortality, and limits It is widely used in clinical practice.
  • Percutaneous ventricular restoration is a new approach to the treatment of heart failure symptoms. It is a leading-edge treatment for patients with old-fashioned anterior wall myocardial infarction and heart failure, in the heart of patients through minimally invasive intervention.
  • the implantation of a "parachute" (CardioKinetix Parachute) has effectively improved the clinical symptoms of patients with heart failure.
  • a "parachute” (CardioKinetix Parachute)
  • Ischemic heart disease can cause heart failure symptoms, ie left ventricular dysfunction.
  • the parachute After the parachute is implanted, the parachute separates the damaged muscles and isolates the dysfunctional muscles from the normal part, thus reducing the overall heart volume and Restore more normal left ventricular function.
  • the indications for percutaneous ventricular remodeling are old anterior wall myocardial infarction with no anterior wall motion or abnormal movement, and decreased left ventricular ejection fraction. Surgery for more than 70 minutes requires half anesthesia. Ultrasound and cardiac CT are used before surgery. For the size of the ventricle, choose the appropriate "parachute".
  • the implanted device is mainly supported by support.
  • the end of the end is placed in the inner wall of the heart, and thus the diameter is large, resulting in a large diameter of the delivery system, thereby causing the risk of the interventional pathway entering the human blood vessel and the heart to damage the blood vessel and the heart valve;
  • the resistance of the aortic valve to the implanted instrument is passed. Difficulty, high surgical complexity, long operation time, greatly increase the risk of surgery and reduce the success rate of surgery; 3, the positioning of the device and the tension of the fitting requirements are high, so the balloon expansion is required to release the shape.
  • an object of the present invention is to provide a left ventricular volume reduction device for solving the problems of high volume, high risk, low success rate, and the like in the prior art for percutaneous ventricular reconstruction. problem.
  • the present invention provides a left ventricular volume reduction device comprising a support frame made of a shape memory alloy, the support frame is covered with a polymer film; and the support frame is released from the apex of the left ventricle
  • the shape of the support frame after release is adapted to the inner wall of the left ventricle, and the end of the support frame away from the apex is provided with an outwardly extending support end, and the support end is caught on the inner wall of the left ventricle, and the support frame is close to One end of the apex is provided with a connecting sleeve detachably connected to the push rod.
  • the support frame is composed of a plurality of support bones, and the ends of the plurality of support bones close to the apex are merged together and connected with the connection sleeve, and the support bone extends away from the end of the apex protruding to the outside of the polymer film covering area to form a support end.
  • the support end of the support bone is a support bead which is curled outward and then curled inward, and the smooth section supporting the bead abuts against the inner wall of the left ventricle.
  • the end of the plurality of support bones near the apex forms a recess that is recessed away from the apex, and the connecting sleeve is located in the recess.
  • the support frame further comprises a woven mesh covering the support surface composed of a plurality of support bones, and the polymer film covers the woven mesh.
  • the support frame is composed of a woven mesh, and the support end of the support frame is a plurality of support wires extending outward from an end of the woven mesh away from the apex.
  • the polymer film is coated on the inside or the outside of the woven mesh.
  • the support frame is composed of a multi-layer woven mesh, and the polymer film is sandwiched between two adjacent woven meshes.
  • the end of the support frame near the apex is further provided with a positioning seat.
  • the positioning seat is woven by a shape memory alloy, and the positioning seat is evenly arranged along the circumferential direction of the support frame. After the positioning seat is released, the positioning seat is abutted on the inner wall of the left ventricle. .
  • the positioning seat is composed of a plurality of spheres, and the plurality of spheres are evenly arranged along the circumferential direction of the support frame.
  • the positioning seat is composed of a plurality of positioning brackets, one end of the positioning bracket is connected with one end of the supporting bracket close to the apex, and the other end of the positioning bracket is provided with a positioning curl which is rolled up and rolled inward, and the positioning curl is smoothed.
  • a plurality of positioning struts are evenly arranged along the circumferential direction of the support frame.
  • the end of the support frame near the apex is provided with a apex locator passing through the apex
  • the end of the apex locator extending from the left ventricle is provided with a lower disc surface
  • the lower disc surface is fitted with the outer wall of the left ventricle
  • the connecting sleeve is located on the lower disc surface
  • the apex locator and the lower surface are woven from a shape memory alloy.
  • a polymer film is interposed in the lower surface.
  • the apex locator is located at one end of the left ventricle and is provided with an upper disc surface, the upper disc surface is adhered to the inner wall of the left ventricle, and the upper disc surface is woven by a shape memory alloy.
  • the end of the support frame close to the apex and the apex positioner are connected by adjusting the waist
  • the adjustment waist is woven by the shape memory alloy
  • the adjustment waist is provided with at least one pleat, and when the waist is stretched, the pleat is pulled apart.
  • the left ventricular volume reduction device of the present invention has the following beneficial effects:
  • the left ventricular volume reduction device can isolate the ventricle region of the left ventricle without function, reduce the contraction and diastolic volume, reduce the left ventricular tension, improve the cardiac function of patients with left ventricular remodeling and heart failure; use the interventional approach and create minimally invasive surgery
  • the design of the apex reduces the trauma to a minimum; reduces the design of the diameter of the delivery sheath through the apical or interventional approach, avoiding the risk of damaging the blood vessels and heart valves; the device is designed with a positioning seat, a apex locator, etc. Good and fit tension, so it does not need to be expanded by balloon during release; the complexity of surgery is greatly reduced, the operation time is shortened, the risk of surgery is greatly reduced, and the success rate of surgery is increased.
  • Figure 1 is a schematic view showing the process of implanting the left ventricle volume reduction device into the left ventricle of the present invention.
  • FIG. 2 is a schematic view showing the structure of the first embodiment of the left ventricular volume reducing device shown in FIG. 1.
  • Figure 3 is a front elevational view of the left ventricular volume reduction device of Figure 2.
  • FIG. 4 is a schematic view showing the structure of the left ventricular volume reducing device shown in FIG. 2 in the left ventricle.
  • Fig. 5 is a view showing the structure of a second embodiment of the left ventricular volume reducing device shown in Fig. 1.
  • Fig. 6 is a schematic view showing the structure of the left ventricular volume reducing device shown in Fig. 5 in the left ventricle.
  • Fig. 7 is a view showing the structure of a third embodiment of the left ventricular volume reducing device shown in Fig. 1.
  • FIG. 8 is a structural schematic view showing the left ventricular volume reducing device shown in FIG. 7 in the left ventricle.
  • Fig. 9 is a view showing the structure of a fourth embodiment of the left ventricular volume reducing device shown in Fig. 1.
  • Figure 10 is a schematic view showing the structure of the left ventricular volume reducing device shown in Figure 9 in the left ventricle.
  • Fig. 11 is a view showing the structure of a fifth embodiment of the left ventricular volume reducing device shown in Fig. 1.
  • Fig. 12 is a view showing the structure of a sixth embodiment of the left ventricular volume reducing device shown in Fig. 1.
  • Fig. 13 is a view showing the structure of the seventh embodiment of the left ventricular volume reducing device shown in Fig. 1 in the left ventricle.
  • Fig. 14 is a view showing the structure of the eighth embodiment of the left ventricular volume reducing device shown in Fig. 1 in the left ventricle.
  • Fig. 15 is a view showing the structure of a ninth embodiment of the left ventricular volume reducing device shown in Fig. 1.
  • Fig. 16 is a view showing the structure of the tenth embodiment of the left ventricular volume reducing device shown in Fig. 1 in the left ventricle.
  • Fig. 17 is a view showing the structure of the eleventh embodiment of the left ventricular volume reducing device shown in Fig. 1 in the left ventricle.
  • the present invention provides a left ventricular volume reduction device comprising a support frame 1 made of a shape memory alloy, the support frame 1 is covered with a polymer film 2; and the support frame 1 is left.
  • the released shape of the support frame 1 is adapted to the inner wall of the left ventricle 3, and the end of the support frame 1 away from the apex 31 is provided with an outwardly extending support end 11 for supporting
  • the end 11 is stuck on the inner wall of the left ventricle 3, and the end of the support frame 1 near the apex 31 is provided with a connecting sleeve 5 detachably connected to the push rod 4.
  • the polymer film 4 may be made of a material such as polyethylene terephthalate PET or expanded polytetrafluoroethylene ePTFT, and the support frame 1 is made of a nickel-titanium alloy; since the nickel-titanium alloy has superelasticity and shape. With the memory function, the entire volume reduction device can be adaptively deformed in the left ventricle 3.
  • the left ventricular volume reduction device is connected to the push rod 4.
  • the push rod 4 and the left ventricular volume reduction device are all located in the delivery sheath 9; then, the push rod 4 pushes the left ventricular volume reduction device to In the left ventricle 3, the support frame 1 and the polymer film 2 are released in a shape compatible with the inner wall of the left ventricle 3, and the support end 11 is caught on the inner wall of the left ventricle 3 to function as a left ventricular volume reducing device.
  • the support frame 1 is composed of a plurality of support bones 12, and a plurality of support bones 12 are close to the apex.
  • One ends of 31 are joined together and connected to the connecting sleeve 5, and one end of the supporting bone 12 extending away from the apex 31 to the outside of the covering area of the polymer film 2 forms a supporting end 11 which is caught on the inner wall of the left ventricle 3.
  • the length at which the support bone 12 protrudes to the outside of the area covered by the polymer film 2 is preferably 1 to 3 mm.
  • the support end 11 of the support bone 12 is a support bead 13 which is turned outward and then curled inward, and the smooth section of the support bead 13 abuts against the inner wall of the left ventricle 3.
  • the support bead 13 functions to support the left ventricle, and does not cause the tip to be inserted into the inner wall of the left ventricle 3 to cause damage, and can also be adjusted or automatically adjusted by the operator after the left ventricular volume reduction device is implanted. Best location.
  • one end of the plurality of support bones 12 near the apex 31 forms a notch 14 that is recessed away from the apex 31, and the coupling sleeve 5 is located in the notch 14.
  • the support frame 1 further includes a woven mesh 15 which is covered on a support surface composed of a plurality of support bones 12, and the polymer film 2 is covered on the woven mesh 15.
  • the function of the woven mesh 15 is to maintain the flat surface morphology of the polymer film 2 between the support bones 12, reduce the occurrence of thrombus, and at the same time enhance the blood-blocking performance and the elastic properties of the entire device.
  • the support frame 1 can be composed solely of a woven mesh 15, and the support end 11 of the support frame 1 is a plurality of support wires 16 projecting outward from the end of the woven mesh 15 away from the apex 31.
  • the polymer film 2 can be covered on the inside or the outside of the woven mesh 15.
  • the support frame 1 may also be composed of a double-layer or multi-layer woven mesh 15, and the polymer film 2 is sandwiched between two adjacent woven meshes 15, or may be covered inside the woven mesh 15 or Externally.
  • the end of the support frame 1 near the apex 31 is further provided with a positioning seat 6 which is woven by a shape memory alloy, and the positioning seat 6 is evenly arranged along the circumferential direction of the support frame 1 .
  • the positioning seat 6 After the positioning seat 6 is released, the positioning seat 6 abuts against the inner wall of the left ventricle 3.
  • the positioning seat 6 functions to relatively fix the position of the volume reducing device in the left ventricle 3.
  • the positioning seat 6 is composed of a plurality of balls 61 which are uniformly arranged along the circumferential direction of the support frame 1.
  • the positioning seat 6 is composed of a plurality of positioning brackets 62.
  • One end of the positioning bracket 62 is connected to one end of the supporting frame 1 near the apex 31, and the other end of the positioning bracket 62 is provided with an outwardly turned and then rolled inwardly.
  • the bead 63, the smooth section of the positioning bead 63 abuts against the inner wall of the left ventricle 3, and the plurality of positioning stays 62 are evenly arranged along the circumferential direction of the support frame 1.
  • the support frame 1 is provided near one end of the apex 31 .
  • the apex locator 7 of the apex 31 the end of the apex locator 7 extending out of the left ventricle 3 is provided with a lower disc surface 71, the lower disc surface 71 is in conformity with the outer wall of the left ventricle 3, and the connecting sleeve 5 is located on the lower disc surface 71, and the apex is positioned
  • the lower surface 71 and the lower surface 71 are woven from a shape memory alloy.
  • the polymer film 2 can be sandwiched in the lower disk surface 71.
  • the apex positioner 7 is located at one end of the left ventricle 3, and is provided with an upper disc surface 72.
  • the upper disc surface 72 is fitted to the inner wall of the left ventricle 3, and the upper disc surface 72 is woven by a shape memory alloy. to make.
  • the apex locator 7, the lower disc surface 71 and the upper disc surface 72 are used to fix the relative position between the support frame 1 and the apex 31.
  • the end of the support frame 1 near the apex 31 and the apex locator 7 are connected by an adjustment waist 8, and the adjustment waist 8 is woven by a shape memory alloy, and the adjustment waist 8 is provided with at least one pleat 81.
  • the waist 8 is adjusted to stretch, the pleats 81 are pulled apart.
  • the pleats 81 of the adjustment waist 8 are stretched or wrinkled, and the distance between the apex locator 7 and the support frame 1 can be adjusted to suit the anatomy of different patients.
  • FIGS. 2 to 4 A first embodiment of the left ventricular volume reduction device is shown in FIGS. 2 to 4, wherein the support frame 1 is a support bone 12, and one end of the plurality of support bones 12 near the apex 31 forms a direction away from the apex 31.
  • FIGS. 5 to 6 A second embodiment of the left ventricular volume reducing device is shown in FIGS. 5 to 6, wherein the support frame 1 is a support bone 12 and is provided with a positioning seat 6 composed of a plurality of balls 61.
  • FIGS. 7 to 8 A third embodiment of the left ventricular volume reducing device is shown in FIGS. 7 to 8, wherein the support frame 1 is a support bone 12, and is provided with a positioning seat 6 composed of a plurality of balls 61 and a lower plate surface 71. Apex locator 7.
  • FIG. 9 A fourth embodiment of the left ventricular volume reducing device is shown in Figures 9 to 10, wherein the support frame 1 is a support bone 12 and is provided with a apex locator 7 having a lower disk surface 71 and an upper disk surface 72.
  • FIG. 11 A fifth embodiment of the left ventricular volume reduction device is shown in FIG. 11 , wherein the support frame 1 is a support bone 12 , and the support end 11 of the support bone 12 is a support bead 13 and is provided with a lower plate surface 71 .
  • FIG. 12 A sixth embodiment of the left ventricular volume reduction device is shown in FIG. 12, wherein the support frame 1 is composed of a support bone 12 and a woven mesh 15.
  • FIG. 13 A seventh embodiment of the left ventricular volume reduction device is shown in FIG. 13 , wherein the support frame 1 is composed of a support bone 12 and a woven mesh 15 , and the support end 11 is a support bead 13 and is provided with a plurality of positioning supports. 62 is composed of a positioning seat 6.
  • FIG. 14 An eighth embodiment of the left ventricular volume reducing device is shown in Fig. 14, wherein the support frame 1 is composed of a support bone 12 and a woven mesh 15, the support end 11 is a support bead 13, and a lower plate surface 71 is provided. , the heart of the upper surface 72 Pointer locator 7.
  • FIG. 15 A ninth embodiment of the left ventricular volume reducing device is shown in Fig. 15, wherein the support frame 1 is composed of a woven mesh 15 and the support end 11 is a support wire 16.
  • FIG. 16 A tenth embodiment of the left ventricular volume reduction device is shown in Fig. 16, wherein the support frame 1 is composed of a double or multi-layer woven mesh 15, and is provided with a apex locator 7 with a lower disk surface 71 for apical positioning.
  • An adjustment waist 8 is also provided between the device 7 and the support frame 1, and the adjustment waist portion 8 is provided with a pleat 81.
  • FIG. 17 An eleventh embodiment of the left ventricular volume reducing device is shown in Fig. 17, wherein the support frame 1 is composed of a double or multi-layer woven mesh 15, and is provided with a apex locator 7 with a lower disk surface 71, a apex An adjustment waist 8 is further provided between the positioner 7 and the support frame 1, and the adjustment waist 8 is provided with two pleats 81.
  • the left ventricular volume reduction device of the present invention can isolate the ventricular region of the left ventricle without function, reduce the contraction and diastolic volume, reduce the left ventricular tension, and improve the cardiac function of patients with left ventricular remodeling and heart failure; And create minimally invasive transapical design to minimize trauma; reduce the design of the diameter of the delivery sheath through the apical or interventional approach to avoid the risk of damage to blood vessels and heart valves; the device uses a positioning seat, apex locator
  • the design of the structure, positioning and tension is strong, so there is no need to use the balloon to expand and shape during release; the surgical complexity is greatly reduced, the operation time is shortened, the risk of surgery is greatly reduced, and the operation is successful. rate. Therefore, the present invention effectively overcomes various shortcomings in the prior art and has high industrial utilization value.

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Abstract

A left ventricle volume reduction device, comprising: a support frame (1) formed from a shape memory alloy, and a polymer membrane (2) covering the support frame (1); when the support frame (1) is released inside a left ventricle (3) from a cardiac apex (31) of the left ventricle (3), the shape of the support frame (1) after release fits to the inner wall of the left ventricle (3). An end of the support frame (1) away from the cardiac apex (31) is provided with a support end (11) extruding outward, and the support end (11) is attached on the inner wall of the left ventricle (3). An end of the support frame (1) close to the cardiac apex (31) is provided with a connection sleeve (5) detachably connected to a push rod (4). The left ventricle volume reduction device can isolate a non-functioning ventricle region of the left ventricle, reduce diastolic and systolic volume and left ventricle tension, and improve left ventricle reconstruction and cardiac function of a patient with heart failure. The device adopts an intervention path and provides a minimally invasive trans-cardiac apex (31) design to reduce trauma to minimum. The design reduces a diameter of a delivery sheath tube (9) in the trans-cardiac apex (31) path or an intervention path, avoiding the risk of damage to blood vessel and heart valves. The present invention adopts designs such as a locating base (6) and a cardiac apex locator (7), has a good locating function and strong fitting tension.

Description

左心室减容装置Left ventricular volume reduction device 技术领域Technical field
本发明涉及一种左心室减容装置。The invention relates to a left ventricular volume reduction device.
背景技术Background technique
心力衰竭是大多数心血管疾病的最终归宿,也是主要的死亡原因,全世界将近有2300万人患有该疾病。Parachute是第一个基于导管技术设计的经皮左室重建装置,该项技术最早报道于2007年,之后在国外逐渐开展,积累了上百例的经验,并于2011年获得欧洲CE认证,结果显示可以有效减轻心力衰竭患者的临床症状,改善心功能,可将晚期心衰患者的五年存活率从30%提高至80%,目前已在欧美应用超过500例。Heart failure is the ultimate destination of most cardiovascular diseases and the leading cause of death, with nearly 23 million people worldwide suffering from the disease. Parachute was the first percutaneous left ventricular reconstruction device based on catheter technology. The technology was first reported in 2007 and has been gradually developed abroad. It has accumulated hundreds of experiences and obtained European CE certification in 2011. It can effectively alleviate the clinical symptoms of patients with heart failure, improve heart function, and increase the five-year survival rate of patients with advanced heart failure from 30% to 80%. Currently, it has been applied in more than 500 cases in Europe and America.
我国心衰患病率0.9%,北方地区1.4%,约有400万心衰患者。据估计,我国急性心肌梗死的发病率约为45/10万~55/10万,目前还呈上升趋势。The prevalence of heart failure in China is 0.9%, 1.4% in the northern region, and there are about 4 million heart failure patients. It is estimated that the incidence of acute myocardial infarction in China is about 45/100,000 to 55/100,000, and it is still on the rise.
一般心衰尤其是慢性过程时均有心脏扩大,以左心室扩大为主,患者生活质量明显下降,临床预后较差,造成巨大的医疗和社会负担。左心室减容术(partial left ventriculectomy,PLV)是近年来治疗晚期扩张型心肌病的一种手术方法,由巴西医师Batista在1996年首次提出。左心室减容术在国内又称作“部分左室切除术”或者“保留性左室切除术”,但左心室减容术存在着较高的心力衰竭、心律失常相关的病死率,限制了其在临床的广泛应用。In general, heart failure, especially in the chronic process, has a heart enlargement, with left ventricular enlargement, the patient's quality of life is significantly reduced, and the clinical prognosis is poor, resulting in a huge medical and social burden. Partial left ventriculectomy (PLV) is a surgical procedure for the treatment of advanced dilated cardiomyopathy in recent years, first proposed by Brazilian physician Batista in 1996. Left ventricular volume reduction surgery is also called "partial left ventricular resection" or "reserved left ventricular resection" in China, but left ventricular volume reduction surgery has higher heart failure, arrhythmia-related mortality, and limits It is widely used in clinical practice.
经皮心室重建术(percutaneous ventricular restoration,PVR)是治疗减轻心衰症状的新途径,它是针对陈旧前壁心肌梗死伴心力衰竭患者的前沿治疗方法,通过微创介入的方法在患者的心脏内植入了“降落伞”(CardioKinetix公司Parachute),有效改善了心力衰竭患者的临床症状。在心脏病发作后,很多左心患者会有左室扩张从而导致心输出量减少,造成心衰症状如气短等。缺血性心脏病会引发心衰症状即左室功能障碍,植入“降落伞”后“降落伞”将损伤的肌肉隔离,从正常部分孤立功能失常的肌肉部分,这样就减少了总体的心容积并恢复更加正常的左室功能。经皮心室重建术的适应症为陈旧性前壁心肌梗死伴前壁无运动或反常运动、左室射血分数下降者,手术70分钟以上,需半麻,术前行超声和心脏CT来测量心室尺寸,选择大小合适的“降落伞”。Percutaneous ventricular restoration (PVR) is a new approach to the treatment of heart failure symptoms. It is a leading-edge treatment for patients with old-fashioned anterior wall myocardial infarction and heart failure, in the heart of patients through minimally invasive intervention. The implantation of a "parachute" (CardioKinetix Parachute) has effectively improved the clinical symptoms of patients with heart failure. After a heart attack, many left heart patients have left ventricular dilatation leading to a decrease in cardiac output, resulting in heart failure symptoms such as shortness of breath. Ischemic heart disease can cause heart failure symptoms, ie left ventricular dysfunction. After the parachute is implanted, the parachute separates the damaged muscles and isolates the dysfunctional muscles from the normal part, thus reducing the overall heart volume and Restore more normal left ventricular function. The indications for percutaneous ventricular remodeling are old anterior wall myocardial infarction with no anterior wall motion or abnormal movement, and decreased left ventricular ejection fraction. Surgery for more than 70 minutes requires half anesthesia. Ultrasound and cardiac CT are used before surgery. For the size of the ventricle, choose the appropriate "parachute".
然而,Parachute也存在缺点和很大的操作难度:1、植入器械由于主要靠支撑 端扎入心室内壁定位,因而直径较大,导致输送系统直径大,从而导致介入途径进入人体血管和心脏有损伤血管和心脏瓣膜等的风险;2、主动脉瓣对植入器械的阻力,通过难度大,手术复杂度高,手术时间长,很大程度上增加了手术危险性降低手术成功率;3、器械的定位和贴合张力要求高,因此在释放时需要借助球囊扩张才能定型。However, Parachute also has shortcomings and great operational difficulties: 1. The implanted device is mainly supported by support. The end of the end is placed in the inner wall of the heart, and thus the diameter is large, resulting in a large diameter of the delivery system, thereby causing the risk of the interventional pathway entering the human blood vessel and the heart to damage the blood vessel and the heart valve; 2. The resistance of the aortic valve to the implanted instrument is passed. Difficulty, high surgical complexity, long operation time, greatly increase the risk of surgery and reduce the success rate of surgery; 3, the positioning of the device and the tension of the fitting requirements are high, so the balloon expansion is required to release the shape.
发明内容Summary of the invention
鉴于以上所述现有技术的缺点,本发明的目的在于提供一种左心室减容装置,用于解决现有技术中经皮心室重建术植入器械较大、风险高、手术成功率低等问题。In view of the above-mentioned shortcomings of the prior art, an object of the present invention is to provide a left ventricular volume reduction device for solving the problems of high volume, high risk, low success rate, and the like in the prior art for percutaneous ventricular reconstruction. problem.
为实现上述目的及其他相关目的,本发明提供一种左心室减容装置,它包括由形状记忆合金制作而成的支撑架,支撑架上覆盖有高分子膜;支撑架从左心室的心尖释放至左心室内时,支撑架的释放后的形状与左心室的内壁相适应,支撑架远离心尖的一端设有向外伸出的支撑端,支撑端卡在左心室的内壁上,支撑架靠近心尖的一端设有与推送杆可拆卸连接的连接套。To achieve the above and other related objects, the present invention provides a left ventricular volume reduction device comprising a support frame made of a shape memory alloy, the support frame is covered with a polymer film; and the support frame is released from the apex of the left ventricle When the left ventricle is in the left ventricle, the shape of the support frame after release is adapted to the inner wall of the left ventricle, and the end of the support frame away from the apex is provided with an outwardly extending support end, and the support end is caught on the inner wall of the left ventricle, and the support frame is close to One end of the apex is provided with a connecting sleeve detachably connected to the push rod.
优选的,支撑架由多根支撑骨组成,多根支撑骨靠近心尖的一端合并至一起,并与连接套连接,支撑骨远离心尖伸出至高分子膜覆盖区域外部的一端形成支撑端。Preferably, the support frame is composed of a plurality of support bones, and the ends of the plurality of support bones close to the apex are merged together and connected with the connection sleeve, and the support bone extends away from the end of the apex protruding to the outside of the polymer film covering area to form a support end.
进一步的优选,支撑骨的支撑端为外翻后再向内卷曲的支撑卷边,支撑卷边的平滑段与左心室的内壁相抵接。Further preferably, the support end of the support bone is a support bead which is curled outward and then curled inward, and the smooth section supporting the bead abuts against the inner wall of the left ventricle.
进一步的优选,多个支撑骨靠近心尖的一端形成一个向远离心尖的方向凹陷的凹口,连接套位于该凹口内。Further preferably, the end of the plurality of support bones near the apex forms a recess that is recessed away from the apex, and the connecting sleeve is located in the recess.
进一步的优选,支撑架还包括编织网,编织网覆盖在多根支撑骨组成的支撑面上,高分子膜覆盖在编织网上。Further preferably, the support frame further comprises a woven mesh covering the support surface composed of a plurality of support bones, and the polymer film covers the woven mesh.
优选的,支撑架由编织网组成,支撑架的支撑端为从编织网远离心尖的一端向外伸出的多根支撑丝。Preferably, the support frame is composed of a woven mesh, and the support end of the support frame is a plurality of support wires extending outward from an end of the woven mesh away from the apex.
进一步的优选,高分子膜覆盖在编织网的内部或外部上。Further preferably, the polymer film is coated on the inside or the outside of the woven mesh.
优选的,支撑架由多层编织网组成,高分子膜夹在相邻两层编织网之间。Preferably, the support frame is composed of a multi-layer woven mesh, and the polymer film is sandwiched between two adjacent woven meshes.
优选的,支撑架靠近心尖的一端还设有定位座,定位座由形状记忆合金编织而成,定位座沿支撑架的周向均匀布置,定位座释放后,定位座抵在左心室的内壁上。Preferably, the end of the support frame near the apex is further provided with a positioning seat. The positioning seat is woven by a shape memory alloy, and the positioning seat is evenly arranged along the circumferential direction of the support frame. After the positioning seat is released, the positioning seat is abutted on the inner wall of the left ventricle. .
进一步的优选,定位座由多个球体组成,多个球体沿支撑架的周向均匀布置。Further preferably, the positioning seat is composed of a plurality of spheres, and the plurality of spheres are evenly arranged along the circumferential direction of the support frame.
进一步的优选,定位座有多根定位撑组成,定位撑的一端与支撑架靠近心尖的一端连接,定位撑的另一端设有外翻后向内卷起的定位卷边,定位卷边的平滑段抵在左 心室的内壁,多根定位撑沿支撑架的周向均匀布置。Further preferably, the positioning seat is composed of a plurality of positioning brackets, one end of the positioning bracket is connected with one end of the supporting bracket close to the apex, and the other end of the positioning bracket is provided with a positioning curl which is rolled up and rolled inward, and the positioning curl is smoothed. Duan arrived at the left The inner wall of the ventricle, a plurality of positioning struts are evenly arranged along the circumferential direction of the support frame.
优选的,支撑架靠近心尖的一端设有穿过心尖的心尖定位器,心尖定位器伸出左心室的一端设有下盘面,下盘面与左心室的外壁相贴合,连接套位于下盘面上,心尖定位器、下盘面由形状记忆合金编织而成。Preferably, the end of the support frame near the apex is provided with a apex locator passing through the apex, the end of the apex locator extending from the left ventricle is provided with a lower disc surface, the lower disc surface is fitted with the outer wall of the left ventricle, and the connecting sleeve is located on the lower disc surface The apex locator and the lower surface are woven from a shape memory alloy.
进一步的优选,下盘面中夹有高分子膜。Further preferably, a polymer film is interposed in the lower surface.
进一步的优选,心尖定位器位于左心室内的一端设有上盘面,上盘面与左心室的内壁贴合,上盘面由形状记忆合金编织而成。Further preferably, the apex locator is located at one end of the left ventricle and is provided with an upper disc surface, the upper disc surface is adhered to the inner wall of the left ventricle, and the upper disc surface is woven by a shape memory alloy.
进一步的优选,支撑架靠近心尖的一端与心尖定位器之间通过调节腰部连接,调节腰部由形状记忆合金编织而成,调节腰部设有至少一个褶皱,调节腰部拉伸时,褶皱被拉开。Further preferably, the end of the support frame close to the apex and the apex positioner are connected by adjusting the waist, the adjustment waist is woven by the shape memory alloy, and the adjustment waist is provided with at least one pleat, and when the waist is stretched, the pleat is pulled apart.
如上所述,本发明左心室减容装置,具有以下有益效果:As described above, the left ventricular volume reduction device of the present invention has the following beneficial effects:
该左心室减容装置,可隔离左心室没有功能的心室区域,减少收缩和舒张容积,降低左心室张力,改善左心室重构和心衰患者的心功能;采用介入途径,并开创微创经心尖的设计,将创伤降低到最小;经心尖途径或介入途径中减小输送鞘管直径的设计,避免损伤血管和心脏瓣膜等的风险;装置采用定位座、心尖定位器等结构的设计,定位好且贴合张力强,因此在释放时无需借助球囊扩张定型;手术复杂度大大减小,手术时间减短,很大程度上降低了手术危险性,增加了手术成功率。The left ventricular volume reduction device can isolate the ventricle region of the left ventricle without function, reduce the contraction and diastolic volume, reduce the left ventricular tension, improve the cardiac function of patients with left ventricular remodeling and heart failure; use the interventional approach and create minimally invasive surgery The design of the apex reduces the trauma to a minimum; reduces the design of the diameter of the delivery sheath through the apical or interventional approach, avoiding the risk of damaging the blood vessels and heart valves; the device is designed with a positioning seat, a apex locator, etc. Good and fit tension, so it does not need to be expanded by balloon during release; the complexity of surgery is greatly reduced, the operation time is shortened, the risk of surgery is greatly reduced, and the success rate of surgery is increased.
附图说明DRAWINGS
图1显示为本发明左心室减容装置植入左心室的过程示意图。Figure 1 is a schematic view showing the process of implanting the left ventricle volume reduction device into the left ventricle of the present invention.
图2显示为图1所示的左心室减容装置的第一种实施方式的结构示意图。2 is a schematic view showing the structure of the first embodiment of the left ventricular volume reducing device shown in FIG. 1.
图3显示为图2所示的左心室减容装置的正视图。Figure 3 is a front elevational view of the left ventricular volume reduction device of Figure 2.
图4显示为图2所示的左心室减容装置位于左心室内的结构示意图。4 is a schematic view showing the structure of the left ventricular volume reducing device shown in FIG. 2 in the left ventricle.
图5显示为图1所示的左心室减容装置的第二种实施方式的结构示意图。Fig. 5 is a view showing the structure of a second embodiment of the left ventricular volume reducing device shown in Fig. 1.
图6显示为图5所示的左心室减容装置位于左心室内的结构示意图。Fig. 6 is a schematic view showing the structure of the left ventricular volume reducing device shown in Fig. 5 in the left ventricle.
图7显示为图1所示的左心室减容装置的第三种实施方式的结构示意图。Fig. 7 is a view showing the structure of a third embodiment of the left ventricular volume reducing device shown in Fig. 1.
图8显示为图7所示的左心室减容装置位于左心室内的结构示意图。FIG. 8 is a structural schematic view showing the left ventricular volume reducing device shown in FIG. 7 in the left ventricle.
图9显示为图1所示的左心室减容装置的第四种实施方式的结构示意图。Fig. 9 is a view showing the structure of a fourth embodiment of the left ventricular volume reducing device shown in Fig. 1.
图10显示为图9所示的左心室减容装置位于左心室内的结构示意图。Figure 10 is a schematic view showing the structure of the left ventricular volume reducing device shown in Figure 9 in the left ventricle.
图11显示为图1所示的左心室减容装置的第五种实施方式的结构示意图。 Fig. 11 is a view showing the structure of a fifth embodiment of the left ventricular volume reducing device shown in Fig. 1.
图12显示为图1所示的左心室减容装置的第六种实施方式的结构示意图。Fig. 12 is a view showing the structure of a sixth embodiment of the left ventricular volume reducing device shown in Fig. 1.
图13显示为图1所示的左心室减容装置的第七种实施方式位于左心室内的结构示意图。Fig. 13 is a view showing the structure of the seventh embodiment of the left ventricular volume reducing device shown in Fig. 1 in the left ventricle.
图14显示为图1所示的左心室减容装置的第八种实施方式位于左心室内的结构示意图。Fig. 14 is a view showing the structure of the eighth embodiment of the left ventricular volume reducing device shown in Fig. 1 in the left ventricle.
图15显示为图1所示的左心室减容装置的第九种实施方式的结构示意图。Fig. 15 is a view showing the structure of a ninth embodiment of the left ventricular volume reducing device shown in Fig. 1.
图16显示为图1所示的左心室减容装置的第十种实施方式位于左心室内的结构示意图。Fig. 16 is a view showing the structure of the tenth embodiment of the left ventricular volume reducing device shown in Fig. 1 in the left ventricle.
图17显示为图1所示的左心室减容装置的第十一种实施方式位于左心室内的结构示意图。Fig. 17 is a view showing the structure of the eleventh embodiment of the left ventricular volume reducing device shown in Fig. 1 in the left ventricle.
元件标号说明Component label description
1  支撑架1 support frame
11 支撑端11 support end
12 支撑骨12 support bone
13 支撑卷边13 support curling
14 凹口14 notches
15 编织网15 woven mesh
16 支撑丝16 support wire
2  高分子膜2 polymer film
3  左心室3 left ventricle
31 心尖31 apex
4  推送杆4 push rod
5  连接套5 connection sleeve
6  定位座6 positioning seat
61 球体61 sphere
62 定位撑62 positioning support
63 定位卷边63 positioning curling
7  心尖定位器 7 apex locator
71 下盘面71 lower disk
72 上盘面72 upper surface
8  调节腰部8 Adjusting the waist
81 褶皱81 folds
9  输送鞘管9 delivery sheath
具体实施方式detailed description
以下由特定的具体实施例说明本发明的实施方式,熟悉此技术的人士可由本说明书所揭露的内容轻易地了解本发明的其他优点及功效。The embodiments of the present invention are described below by way of specific embodiments, and those skilled in the art can readily understand other advantages and functions of the present invention from the disclosure.
请参阅图1至图17。须知,本说明书所附图式所绘示的结构、比例、大小等,均仅用以配合说明书所揭示的内容,以供熟悉此技术的人士了解与阅读,并非用以限定本发明可实施的限定条件,故不具技术上的实质意义,任何结构的修饰、比例关系的改变或大小的调整,在不影响本发明所能产生的功效及所能达成的目的下,均应仍落在本发明所揭示的技术内容得能涵盖的范围内。同时,本说明书中所引用的如“上”、“下”、“左”、“右”、“中间”及“一”等的用语,亦仅为便于叙述的明了,而非用以限定本发明可实施的范围,其相对关系的改变或调整,在无实质变更技术内容下,当亦视为本发明可实施的范畴。Please refer to Figure 1 to Figure 17. It should be understood that the structures, the proportions, the sizes, and the like, which are illustrated in the specification of the present specification, are only used to clarify the contents disclosed in the specification for understanding and reading by those skilled in the art, and are not intended to limit the implementation of the present invention. The conditions are limited, so it is not technically meaningful. Any modification of the structure, change of the proportional relationship or adjustment of the size should remain in the present invention without affecting the effects and the achievable purposes of the present invention. The disclosed technical content is within the scope of the disclosure. In the meantime, the terms "upper", "lower", "left", "right", "intermediate" and "one" as used in this specification are also for convenience of description, and are not intended to limit the present. The scope of the invention can be implemented, and the change or adjustment of the relative relationship is considered to be within the scope of the invention.
如图1至图17所示,本发明提供一种左心室减容装置,它包括由形状记忆合金制作而成的支撑架1,支撑架1上覆盖有高分子膜2;支撑架1从左心室3的心尖31释放至左心室3内时,支撑架1的释放后的形状与左心室3的内壁相适应,支撑架1远离心尖31的一端设有向外伸出的支撑端11,支撑端11卡在左心室3的内壁上,支撑架1靠近心尖31的一端设有与推送杆4可拆卸连接的连接套5。其中,高分子膜4可以由聚对苯二甲酸乙二醇酯PET或膨体聚四氟乙烯ePTFT等材料构成,支撑架1由镍钛合金制作而成;由于镍钛合金具有超弹性和形状记忆功能,整个减容装置可以在左心室3内适应性变形。As shown in FIG. 1 to FIG. 17, the present invention provides a left ventricular volume reduction device comprising a support frame 1 made of a shape memory alloy, the support frame 1 is covered with a polymer film 2; and the support frame 1 is left. When the apex 31 of the ventricle 3 is released into the left ventricle 3, the released shape of the support frame 1 is adapted to the inner wall of the left ventricle 3, and the end of the support frame 1 away from the apex 31 is provided with an outwardly extending support end 11 for supporting The end 11 is stuck on the inner wall of the left ventricle 3, and the end of the support frame 1 near the apex 31 is provided with a connecting sleeve 5 detachably connected to the push rod 4. The polymer film 4 may be made of a material such as polyethylene terephthalate PET or expanded polytetrafluoroethylene ePTFT, and the support frame 1 is made of a nickel-titanium alloy; since the nickel-titanium alloy has superelasticity and shape. With the memory function, the entire volume reduction device can be adaptively deformed in the left ventricle 3.
如图1所示,左心室减容装置与推送杆4连接,初始状态下,推送杆4、左心室减容装置均位于输送鞘管9内;然后,推送杆4推送左心室减容装置至左心室3内,支撑架1连同高分子膜2释放为与左心室3的内壁相适应的形状,支撑端11卡在左心室3的内壁上,起到固定左心室减容装置的作用。As shown in Fig. 1, the left ventricular volume reduction device is connected to the push rod 4. In the initial state, the push rod 4 and the left ventricular volume reduction device are all located in the delivery sheath 9; then, the push rod 4 pushes the left ventricular volume reduction device to In the left ventricle 3, the support frame 1 and the polymer film 2 are released in a shape compatible with the inner wall of the left ventricle 3, and the support end 11 is caught on the inner wall of the left ventricle 3 to function as a left ventricular volume reducing device.
如图2至图11所示,支撑架1由多根支撑骨12组成,多根支撑骨12靠近心尖 31的一端合并至一起,并与连接套5连接,支撑骨12远离心尖31伸出至高分子膜2覆盖区域外部的一端形成支撑端11,卡在左心室3的内壁上。支撑骨12伸出至高分子膜2覆盖区域外部的长度优选为1~3mm。As shown in FIG. 2 to FIG. 11, the support frame 1 is composed of a plurality of support bones 12, and a plurality of support bones 12 are close to the apex. One ends of 31 are joined together and connected to the connecting sleeve 5, and one end of the supporting bone 12 extending away from the apex 31 to the outside of the covering area of the polymer film 2 forms a supporting end 11 which is caught on the inner wall of the left ventricle 3. The length at which the support bone 12 protrudes to the outside of the area covered by the polymer film 2 is preferably 1 to 3 mm.
如图11、图13、图14所示,支撑骨12的支撑端11为外翻后再向内卷曲的支撑卷边13,支撑卷边13的平滑段与左心室3的内壁相抵接。该支撑卷边13起到支撑左心室的作用,同时不至于将尖端扎入左心室3的内壁而造成损伤,还可以使左心室减容装置植入后,可以被术者调节或自动调节至最佳位置。As shown in Figs. 11, 13, and 14, the support end 11 of the support bone 12 is a support bead 13 which is turned outward and then curled inward, and the smooth section of the support bead 13 abuts against the inner wall of the left ventricle 3. The support bead 13 functions to support the left ventricle, and does not cause the tip to be inserted into the inner wall of the left ventricle 3 to cause damage, and can also be adjusted or automatically adjusted by the operator after the left ventricular volume reduction device is implanted. Best location.
如图2至图4所示,多个支撑骨12靠近心尖31的一端形成一个向远离心尖31的方向凹陷的凹口14,连接套5位于该凹口14内。As shown in FIGS. 2 to 4, one end of the plurality of support bones 12 near the apex 31 forms a notch 14 that is recessed away from the apex 31, and the coupling sleeve 5 is located in the notch 14.
如图12至图14所示,支撑架1还包括编织网15,编织网15覆盖在多根支撑骨12组成的支撑面上,高分子膜2覆盖在编织网15上。编织网15的作用是保持支撑骨12之间的高分子膜2的表面形态的平整,减少血栓产生,同时增强阻血性能及整个装置的弹性性能。As shown in FIGS. 12 to 14, the support frame 1 further includes a woven mesh 15 which is covered on a support surface composed of a plurality of support bones 12, and the polymer film 2 is covered on the woven mesh 15. The function of the woven mesh 15 is to maintain the flat surface morphology of the polymer film 2 between the support bones 12, reduce the occurrence of thrombus, and at the same time enhance the blood-blocking performance and the elastic properties of the entire device.
如图15所示,支撑架1可以单独由编织网15组成,支撑架1的支撑端11为从编织网15远离心尖31的一端向外伸出的多根支撑丝16。此时,高分子膜2可覆盖在编织网15的内部或外部上。单独使用编织网15作为支撑架1,可减小减容装置收入输送鞘管9内时的直径,因此可以采用直径更小的输送鞘管9,减小介入途径中输送鞘管9对血管和心脏瓣膜、腱索等结构的损伤。As shown in Fig. 15, the support frame 1 can be composed solely of a woven mesh 15, and the support end 11 of the support frame 1 is a plurality of support wires 16 projecting outward from the end of the woven mesh 15 away from the apex 31. At this time, the polymer film 2 can be covered on the inside or the outside of the woven mesh 15. By using the woven mesh 15 as the support frame 1 alone, the diameter of the volume reduction device when it is received into the delivery sheath 9 can be reduced, so that the delivery sheath 9 having a smaller diameter can be used, and the delivery sheath 9 can be reduced in the interventional route to the blood vessel and Damage to structures such as heart valves and chordae.
如图16至图17所示,支撑架1还可由双层或多层编织网15组成,高分子膜2夹在相邻两层编织网15之间,也可覆盖在编织网15的内部或外部上。As shown in FIG. 16 to FIG. 17, the support frame 1 may also be composed of a double-layer or multi-layer woven mesh 15, and the polymer film 2 is sandwiched between two adjacent woven meshes 15, or may be covered inside the woven mesh 15 or Externally.
如图5至图8、图13所示,支撑架1靠近心尖31的一端还设有定位座6,定位座6由形状记忆合金编织而成,定位座6沿支撑架1的周向均匀布置,定位座6释放后,定位座6抵在左心室3的内壁上。定位座6起到使减容装置在左心室3中的位置相对固定的作用。As shown in FIG. 5 to FIG. 8 and FIG. 13 , the end of the support frame 1 near the apex 31 is further provided with a positioning seat 6 which is woven by a shape memory alloy, and the positioning seat 6 is evenly arranged along the circumferential direction of the support frame 1 . After the positioning seat 6 is released, the positioning seat 6 abuts against the inner wall of the left ventricle 3. The positioning seat 6 functions to relatively fix the position of the volume reducing device in the left ventricle 3.
如图5至图8所示,定位座6由多个球体61组成,多个球体61沿支撑架1的周向均匀布置。As shown in FIGS. 5 to 8, the positioning seat 6 is composed of a plurality of balls 61 which are uniformly arranged along the circumferential direction of the support frame 1.
如图13所示,定位座6有多根定位撑62组成,定位撑62的一端与支撑架1靠近心尖31的一端连接,定位撑62的另一端设有外翻后向内卷起的定位卷边63,定位卷边63的平滑段抵在左心室3的内壁,多根定位撑62沿支撑架1的周向均匀布置。As shown in FIG. 13, the positioning seat 6 is composed of a plurality of positioning brackets 62. One end of the positioning bracket 62 is connected to one end of the supporting frame 1 near the apex 31, and the other end of the positioning bracket 62 is provided with an outwardly turned and then rolled inwardly. The bead 63, the smooth section of the positioning bead 63 abuts against the inner wall of the left ventricle 3, and the plurality of positioning stays 62 are evenly arranged along the circumferential direction of the support frame 1.
如图7至图11、图14、图16至图17所示,支撑架1靠近心尖31的一端设有穿 过心尖31的心尖定位器7,心尖定位器7伸出左心室3的一端设有下盘面71,下盘面71与左心室3的外壁相贴合,连接套5位于下盘面71上,心尖定位器7、下盘面71由形状记忆合金编织而成。如图16至图17所示,下盘面71中可夹有高分子膜2。As shown in FIG. 7 to FIG. 11 , FIG. 14 , and FIG. 16 to FIG. 17 , the support frame 1 is provided near one end of the apex 31 . The apex locator 7 of the apex 31, the end of the apex locator 7 extending out of the left ventricle 3 is provided with a lower disc surface 71, the lower disc surface 71 is in conformity with the outer wall of the left ventricle 3, and the connecting sleeve 5 is located on the lower disc surface 71, and the apex is positioned The lower surface 71 and the lower surface 71 are woven from a shape memory alloy. As shown in FIGS. 16 to 17, the polymer film 2 can be sandwiched in the lower disk surface 71.
如图9至图11、图14所示,心尖定位器7位于左心室3内的一端设有上盘面72,上盘面72与左心室3的内壁贴合,上盘面72由形状记忆合金编织而成。心尖定位器7、下盘面71和上盘面72用于固定支撑架1与心尖31之间的相对位置。As shown in FIGS. 9 to 11 and 14, the apex positioner 7 is located at one end of the left ventricle 3, and is provided with an upper disc surface 72. The upper disc surface 72 is fitted to the inner wall of the left ventricle 3, and the upper disc surface 72 is woven by a shape memory alloy. to make. The apex locator 7, the lower disc surface 71 and the upper disc surface 72 are used to fix the relative position between the support frame 1 and the apex 31.
如图16至图17所示,支撑架1靠近心尖31的一端与心尖定位器7之间通过调节腰部8连接,调节腰部8由形状记忆合金编织而成,调节腰部8设有至少一个褶皱81,调节腰部8拉伸时,褶皱81被拉开。在心尖定位器7受牵拉时,调节腰部8的褶皱81伸展或皱起,可调节心尖定位器7与支撑架1之间的距离,可适合不同患者的解剖结构。As shown in FIGS. 16 to 17, the end of the support frame 1 near the apex 31 and the apex locator 7 are connected by an adjustment waist 8, and the adjustment waist 8 is woven by a shape memory alloy, and the adjustment waist 8 is provided with at least one pleat 81. When the waist 8 is adjusted to stretch, the pleats 81 are pulled apart. When the apex locator 7 is pulled, the pleats 81 of the adjustment waist 8 are stretched or wrinkled, and the distance between the apex locator 7 and the support frame 1 can be adjusted to suit the anatomy of different patients.
该左心室减容装置的第一种实施方式如图2至图4所示,其中,支撑架1为支撑骨12,且多个支撑骨12靠近心尖31的一端形成一个向远离心尖31的方向凹陷的凹口14,连接套5位于该凹口14内。A first embodiment of the left ventricular volume reduction device is shown in FIGS. 2 to 4, wherein the support frame 1 is a support bone 12, and one end of the plurality of support bones 12 near the apex 31 forms a direction away from the apex 31. A recessed recess 14 in which the connecting sleeve 5 is located.
该左心室减容装置的第二种实施方式如图5至图6所示,其中,支撑架1为支撑骨12,且设有由多个球体61组成的定位座6。A second embodiment of the left ventricular volume reducing device is shown in FIGS. 5 to 6, wherein the support frame 1 is a support bone 12 and is provided with a positioning seat 6 composed of a plurality of balls 61.
该左心室减容装置的第三种实施方式如图7至图8所示,其中,支撑架1为支撑骨12,且设有由多个球体61组成的定位座6和带有下盘面71的心尖定位器7。A third embodiment of the left ventricular volume reducing device is shown in FIGS. 7 to 8, wherein the support frame 1 is a support bone 12, and is provided with a positioning seat 6 composed of a plurality of balls 61 and a lower plate surface 71. Apex locator 7.
该左心室减容装置的第四种实施方式如图9至图10所示,其中,支撑架1为支撑骨12,且设有带有下盘面71、上盘面72的心尖定位器7。A fourth embodiment of the left ventricular volume reducing device is shown in Figures 9 to 10, wherein the support frame 1 is a support bone 12 and is provided with a apex locator 7 having a lower disk surface 71 and an upper disk surface 72.
该左心室减容装置的第五种实施方式如图11所示,其中,支撑架1为支撑骨12,支撑骨12的支撑端11为支撑卷边13,且设有带有下盘面71、上盘面72的心尖定位器7。A fifth embodiment of the left ventricular volume reduction device is shown in FIG. 11 , wherein the support frame 1 is a support bone 12 , and the support end 11 of the support bone 12 is a support bead 13 and is provided with a lower plate surface 71 . The apex locator 7 of the upper disk surface 72.
该左心室减容装置的第六种实施方式如图12所示,其中,支撑架1由支撑骨12与编织网15组成。A sixth embodiment of the left ventricular volume reduction device is shown in FIG. 12, wherein the support frame 1 is composed of a support bone 12 and a woven mesh 15.
该左心室减容装置的第七种实施方式如图13所示,其中,支撑架1由支撑骨12与编织网15组成,支撑端11为支撑卷边13,还设有由多根定位撑62组成的定位座6。A seventh embodiment of the left ventricular volume reduction device is shown in FIG. 13 , wherein the support frame 1 is composed of a support bone 12 and a woven mesh 15 , and the support end 11 is a support bead 13 and is provided with a plurality of positioning supports. 62 is composed of a positioning seat 6.
该左心室减容装置的第八种实施方式如图14所示,其中,支撑架1由支撑骨12与编织网15组成,支撑端11为支撑卷边13,还设有带有下盘面71、上盘面72的心 尖定位器7。An eighth embodiment of the left ventricular volume reducing device is shown in Fig. 14, wherein the support frame 1 is composed of a support bone 12 and a woven mesh 15, the support end 11 is a support bead 13, and a lower plate surface 71 is provided. , the heart of the upper surface 72 Pointer locator 7.
该左心室减容装置的第九种实施方式如图15所示,其中,支撑架1由编织网15组成,支撑端11为支撑丝16。A ninth embodiment of the left ventricular volume reducing device is shown in Fig. 15, wherein the support frame 1 is composed of a woven mesh 15 and the support end 11 is a support wire 16.
该左心室减容装置的第十种实施方式如图16所示,其中,支撑架1由双层或多层编织网15组成,且设有带有下盘面71的心尖定位器7,心尖定位器7与支撑架1之间还设有调节腰部8,调节腰部8设有一个褶皱81。A tenth embodiment of the left ventricular volume reduction device is shown in Fig. 16, wherein the support frame 1 is composed of a double or multi-layer woven mesh 15, and is provided with a apex locator 7 with a lower disk surface 71 for apical positioning. An adjustment waist 8 is also provided between the device 7 and the support frame 1, and the adjustment waist portion 8 is provided with a pleat 81.
该左心室减容装置的第十一种实施方式如图17所示,其中,支撑架1由双层或多层编织网15组成,且设有带有下盘面71的心尖定位器7,心尖定位器7与支撑架1之间还设有调节腰部8,调节腰部8设有两个褶皱81。An eleventh embodiment of the left ventricular volume reducing device is shown in Fig. 17, wherein the support frame 1 is composed of a double or multi-layer woven mesh 15, and is provided with a apex locator 7 with a lower disk surface 71, a apex An adjustment waist 8 is further provided between the positioner 7 and the support frame 1, and the adjustment waist 8 is provided with two pleats 81.
综上所述,本发明左心室减容装置,可隔离左心室没有功能的心室区域,减少收缩和舒张容积,降低左心室张力,改善左心室重构和心衰患者的心功能;采用介入途径,并开创微创经心尖的设计,将创伤降低到最小;经心尖途径或介入途径中减小输送鞘管直径的设计,避免损伤血管和心脏瓣膜等的风险;装置采用定位座、心尖定位器等结构的设计,定位好且贴合张力强,因此在释放时无需借助球囊扩张定型;手术复杂度大大减小,手术时间减短,很大程度上降低了手术危险性,增加了手术成功率。所以,本发明有效克服了现有技术中的种种缺点而具高度产业利用价值。In summary, the left ventricular volume reduction device of the present invention can isolate the ventricular region of the left ventricle without function, reduce the contraction and diastolic volume, reduce the left ventricular tension, and improve the cardiac function of patients with left ventricular remodeling and heart failure; And create minimally invasive transapical design to minimize trauma; reduce the design of the diameter of the delivery sheath through the apical or interventional approach to avoid the risk of damage to blood vessels and heart valves; the device uses a positioning seat, apex locator The design of the structure, positioning and tension is strong, so there is no need to use the balloon to expand and shape during release; the surgical complexity is greatly reduced, the operation time is shortened, the risk of surgery is greatly reduced, and the operation is successful. rate. Therefore, the present invention effectively overcomes various shortcomings in the prior art and has high industrial utilization value.
上述实施例仅例示性说明本发明的原理及其功效,而非用于限制本发明。任何熟悉此技术的人士皆可在不违背本发明的精神及范畴下,对上述实施例进行修饰或改变。因此,举凡所属技术领域中具有通常知识者在未脱离本发明所揭示的精神与技术思想下所完成的一切等效修饰或改变,仍应由本发明的权利要求所涵盖。 The above-described embodiments are merely illustrative of the principles of the invention and its effects, and are not intended to limit the invention. Modifications or variations of the above-described embodiments may be made by those skilled in the art without departing from the spirit and scope of the invention. Therefore, all equivalent modifications or changes made by those skilled in the art without departing from the spirit and scope of the invention will be covered by the appended claims.

Claims (15)

  1. 一种左心室减容装置,其特征在于:它包括由形状记忆合金制作而成的支撑架(1),所述支撑架(1)上覆盖有高分子膜(2);所述支撑架(1)从左心室(3)的心尖(31)释放至左心室(3)内时,所述支撑架(1)释放后的形状与左心室(3)的内壁相适应,所述支撑架(1)远离心尖(31)的一端设有向外伸出的支撑端(11),所述支撑端(11)卡在左心室(3)的内壁上,所述支撑架(1)靠近心尖(31)的一端设有与推送杆(4)可拆卸连接的连接套(5)。A left ventricular volume reduction device, characterized in that it comprises a support frame (1) made of a shape memory alloy, the support frame (1) is covered with a polymer film (2); the support frame ( 1) When released from the apex (31) of the left ventricle (3) into the left ventricle (3), the shape of the support frame (1) after release is adapted to the inner wall of the left ventricle (3), the support frame ( 1) One end away from the apex (31) is provided with an outwardly projecting support end (11) which is caught on the inner wall of the left ventricle (3), which is close to the apex ( One end of 31) is provided with a connecting sleeve (5) detachably connected to the push rod (4).
  2. 根据权利要求1所述的左心室减容装置,其特征在于:所述支撑架(1)由多根支撑骨(12)组成,所述多根支撑骨(12)靠近心尖(31)的一端合并至一起,并与所述连接套(5)连接,所述支撑骨(12)远离心尖(31)伸出至所述高分子膜(2)覆盖区域外部的一端形成支撑端(11)。The left ventricular volume reduction device according to claim 1, wherein the support frame (1) is composed of a plurality of support bones (12), and the plurality of support bones (12) are close to one end of the apex (31). The two are joined together and connected to the connecting sleeve (5), and the supporting bone (12) extends away from the apex (31) to an end of the outer surface of the polymer film (2) to form a supporting end (11).
  3. 根据权利要求2所述的左心室减容装置,其特征在于:所述支撑骨(12)的支撑端(11)为外翻后再向内卷曲的支撑卷边(13),所述支撑卷边(13)的平滑段与左心室(3)的内壁相抵接。The left ventricular volume reducing device according to claim 2, wherein the supporting end (11) of the supporting bone (12) is a supporting bead (13) which is curled outward and then curled inward, the supporting roll The smooth section of the side (13) abuts against the inner wall of the left ventricle (3).
  4. 根据权利要求2所述的左心室减容装置,其特征在于:所述多个支撑骨(12)靠近心尖(31)的一端形成一个向远离心尖(31)的方向凹陷的凹口(14),所述连接套(5)位于该凹口(14)内。The left ventricular volume reduction device according to claim 2, wherein the plurality of support bones (12) are adjacent to one end of the apex (31) to form a recess (14) recessed away from the apex (31). The connecting sleeve (5) is located in the recess (14).
  5. 根据权利要求2所述的左心室减容装置,其特征在于:所述支撑架(1)还包括编织网(15),所述编织网(15)覆盖在所述多根支撑骨(12)组成的支撑面上,所述高分子膜(2)覆盖在所述编织网(15)上。The left ventricular volume reduction device according to claim 2, wherein the support frame (1) further comprises a woven mesh (15), and the woven mesh (15) covers the plurality of support bones (12) On the support surface of the composition, the polymer film (2) is covered on the woven mesh (15).
  6. 根据权利要求1所述的左心室减容装置,其特征在于:所述支撑架(1)由编织网(15)组成,所述支撑架(1)的支撑端(11)为从所述编织网(15)远离心尖(31)的一端向外伸出的多根支撑丝(16)。A left ventricular volume reducing device according to claim 1, wherein said support frame (1) is composed of a woven mesh (15), and said support end (11) of said support frame (1) is woven from said The mesh (15) is a plurality of support wires (16) extending outward from one end of the apex (31).
  7. 根据权利要求6所述的左心室减容装置,其特征在于:所述高分子膜(2)覆盖在所述编织网(15)的内部或外部上。The left ventricular volume reducing device according to claim 6, wherein the polymer film (2) covers the inside or the outside of the woven mesh (15).
  8. 根据权利要求1所述的左心室减容装置,其特征在于:所述支撑架(1)由多层编织网(15)组成,所述高分子膜(2)夹在相邻两层编织网(15)之间。The left ventricular volume reduction device according to claim 1, wherein the support frame (1) is composed of a multilayer woven mesh (15), and the polymer film (2) is sandwiched between two adjacent woven meshes. Between (15).
  9. 根据权利要求1所述的左心室减容装置,其特征在于:所述支撑架(1)靠近心尖(31)的一端还设有定位座(6),所述定位座(6)由形状记忆合金编织而 成,所述定位座(6)沿所述支撑架(1)的周向均匀布置,所述定位座(6)释放后,所述定位座(6)抵在左心室(3)的内壁上。The left ventricular volume reduction device according to claim 1, characterized in that: at one end of the support frame (1) near the apex (31), a positioning seat (6) is further provided, and the positioning seat (6) is shaped by a shape memory. Alloy weaving The positioning seat (6) is evenly arranged along the circumferential direction of the support frame (1). After the positioning seat (6) is released, the positioning seat (6) abuts against the inner wall of the left ventricle (3). .
  10. 根据权利要求9所述的左心室减容装置,其特征在于:所述定位座(6)由多个球体(61)组成,所述多个球体(61)沿所述支撑架(1)的周向均匀布置。The left ventricular volume reduction device according to claim 9, wherein the positioning seat (6) is composed of a plurality of spheres (61) along the support frame (1) The circumferential direction is evenly arranged.
  11. 根据权利要求9所述的左心室减容装置,其特征在于:所述定位座(6)有多根定位撑(62)组成,所述定位撑(62)的一端与所述支撑架(1)靠近心尖(31)的一端连接,所述定位撑(62)的另一端设有外翻后向内卷起的定位卷边(63),所述定位卷边(63)的平滑段抵在左心室(3)的内壁,所述多根定位撑(62)沿所述支撑架(1)的周向均匀布置。The left ventricular volume reduction device according to claim 9, wherein the positioning seat (6) is composed of a plurality of positioning supports (62), one end of the positioning support (62) and the support frame (1) Attached to one end of the apex (31), the other end of the positioning bracket (62) is provided with a positioning bead (63) which is rolled up and then rolled inward, and the smooth section of the positioning bead (63) is The inner wall of the left ventricle (3), the plurality of positioning struts (62) are evenly arranged along the circumferential direction of the support frame (1).
  12. 根据权利要求1所述的左心室减容装置,其特征在于:所述支撑架(1)靠近心尖(31)的一端设有穿过心尖(31)的心尖定位器(7),所述心尖定位器(7)伸出左心室(3)的一端设有下盘面(71),所述下盘面(71)与所述左心室(3)的外壁相贴合,所述连接套(5)位于所述下盘面(71)上,所述心尖定位器(7)、下盘面(71)由形状记忆合金编织而成。The left ventricular volume reducing device according to claim 1, characterized in that: one end of the support frame (1) near the apex (31) is provided with a apex locator (7) passing through the apex (31), the apex One end of the positioner (7) extending out of the left ventricle (3) is provided with a lower disc surface (71), and the lower disc surface (71) is fitted to the outer wall of the left ventricle (3), and the connecting sleeve (5) Located on the lower disk surface (71), the apex locator (7) and the lower disk surface (71) are woven from a shape memory alloy.
  13. 根据权利要求12所述的左心室减容装置,其特征在于:所述下盘面(71)中夹有高分子膜(2)。The left ventricular volume reducing device according to claim 12, wherein a polymer film (2) is interposed in the lower disk surface (71).
  14. 根据权利要求12所述的左心室减容装置,其特征在于:所述心尖定位器(7)位于左心室(3)内的一端设有上盘面(72),所述上盘面(72)与所述左心室(3)的内壁贴合,所述上盘面(72)由形状记忆合金编织而成。The left ventricular volume reducing device according to claim 12, wherein an end of the apex locator (7) located in the left ventricle (3) is provided with an upper disk surface (72), and the upper disk surface (72) is The inner wall of the left ventricle (3) is fitted, and the upper disc surface (72) is woven from a shape memory alloy.
  15. 根据权利要求12所述的左心室减容装置,其特征在于:所述支撑架(1)靠近心尖(31)的一端与心尖定位器(7)之间通过调节腰部(8)连接,所述调节腰部(8)由形状记忆合金编织而成,所述调节腰部(8)设有至少一个褶皱(81),所述调节腰部(8)拉伸时,所述褶皱(81)被拉开。 The left ventricular volume reduction device according to claim 12, characterized in that: the end of the support frame (1) close to the apex (31) and the apex positioner (7) are connected by an adjustment waist (8), The adjustment waist (8) is woven from a shape memory alloy, and the adjustment waist (8) is provided with at least one pleat (81) which is pulled apart when the adjustment waist (8) is stretched.
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