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血管旋磨器械技术分析报告

嘉峪检测网        2022-08-18 11:54

前言导读

 

血管钙化(vascular calcification)是动脉粥样硬化、高血压、糖尿病血管病变、血管损伤、慢性肾病和衰老等普遍存在的共同的病理表现。

 

主要表现为血管壁僵硬性增加,顺应性降低,易导致心肌缺血、左心室肥大和心力衰竭,引发血栓形成、斑块破裂,是心脑血管疾病高发病率和高死亡率的重要因素之一;亦是动脉粥样硬化心血管事件、脑卒中和外周血管病发生的重要标志分子。

 

血管钙化是指钙质物沉积在血管壁的一种病变,会导致血管壁变硬,顺应性降低。根据《冠状动脉钙化病变诊治中国专家共识(2021版)》,冠状动脉钙化随年龄增加而增加。此外,外周动脉的钙化也是常见问题。无论是冠状动脉还是外周动脉的钙化,都是介入治疗中非常棘手的病变。

 

对于血管钙化疾病,血管减容装置的出现为冠脉、外周动脉疾病的治疗提供了新思路。

 

血管减容装置是旨在切除、剃除或汽化动脉粥样硬化或钙化斑块的斑块切除术设备:一般可以包括定向斑块切除装置、螺旋斑块切除系统、激光斑块切除装置、机械切栓术几种技术方向,其中的定向斑块切除装置最为常见,也是较为关注的领域之一,其主要包括括斑块旋磨(rotational Atherecto-my,RA)、斑块旋切(directional atherecto-my,DA)两种类型。

 

目前血管减容装置市场基本被以美敦力(Medtronic)、CSI(Cardiovascular Systems, Inc(CSI)为代表的外资企业所垄断,如CSI的DIAMONDBACK360斑块旋磨产品就是典型代表。

 

Diamondback360 简介

                      

全球范围内,Cardiovascular Systems, Inc(CSI)在外周、冠脉血管旋磨领域占据优势地位。

 

Cardiovascular Systems是一家医疗设备公司,从事血管和冠心病治疗解决方案的开发和商业化。它为外周和冠状动脉的商业应用提供动脉粥样硬化切除系统。该公司成立于1989年,总部设在美国明尼苏达州圣保罗。

 

Cardiovascular Systems, Inc为了有效治疗血管钙化病,开发出两款血管钙化旋切系统--Diamondback 360,分别适用于外周动脉疾病(PAD)与冠状动脉疾病(CAD)。

 

技术概览

                         

以CAD版Diamondback 360为例,DIAMONDBACK360系统的主要组成部分可参照如下附图。

 

Diamondback结合不同的打磨和脉动力来治疗钙化形态,根据不同的产品类型,包括结节、偏心(不规则)和同心(环形)。该设备还具有GlideAssist功能,该功能可以跟踪,更轻松地移除设备并重新放置,尤其是在具有挑战性的解剖结构中,可以更顺畅地重新放置。

 

以PAD版Diamondback 360为例,DIAMONDBACK360系统技术相关产品的结构组成和工作原理可参考如下视频:

 

专利概览

                       

笔者对Diamondback的相关专利根据类别分别进行了整理和剖析,这里笔者从众多专利中选择了若干进行了解析,相关相关结果如下:Diamondback的完整专利清单和分析笔者也已开展完成,如感兴趣可以与笔者取得联系,共同交流学习:

 

公开/公告号

US10299820B2

申请日

2016-02-18

发明名称

Methods and systems for disrupting calcified walls of biological conduits and calcified lesions therein

解决的技术问题

The present invention generally relates to methods and systems used for removing or modifying tissue from bodily passageways or conduits, such as removal and/or modification of atherosclerotic plaque from arteries, using a high-speed rotational atherectomy device. More specifically, the present invention relates to softening or otherwise disrupting calcification within a lesion and/or the intimal and/or medial wall layers of the passageway or conduit, e.g., an artery, using a combination of a low-frequency orbital motion and/or a high-frequency pulsatile frequency thereby increasing the compliance of the lesion and/or wall layers.

技术方案

The present system is directed in various embodiments to rotational atherectomy systems and methods generally. More specifically, a method for methodically softening and disrupting calcification within the wall of a biological conduit or lumen. This result is achieved by use of at least one eccentric head that, during high-speed rotation within the exemplary lumen, produces a combination of a low-frequency orbital motion comprising a force that is exerted against the lumen wall, with concomitant deflection of same, and a high-frequency pulsatile frequency, also with concomitant exertion of force against the lumen wall and deflection of same. These force-driven deflections produce shockwaves  within the layers of the exemplary artery's wall layers, resulting in systematic disruptions of any calcification within the intimal and/or medial layers of the subject artery. In addition, any calcification within the occlusion is also softened and disrupted, increasing compliance of the vessel and/or lesion.

相关附图

血管旋磨器械技术分析报告         

 

公开/公告号

US7174240B2

申请日

2002-10-16

发明名称

Control system for rotational angioplasty device

解决的技术问题

In one aspect the present invention is directed to a rotational atherectomy system. In one embodiment the system comprises a rotational atherectomy device, a fluid source adapted to supply fluid to the device, a pump system adapted to pump fluid from the fluid source to the device, a first switch adapted to increase a flow of fluid from the fluid source to the device from a first flow rate to a second flow rate when the switch is activated and a second switch adapted to activate a rotation of a drive shaft in the device when the second switch is activated.

技术方案

A method for controlling fluid flow in a rotational atherectomy device. A source of fluid is provided through a pump to the rotational atherectomy device, wherein the pump maintains the fluid flow at a minimal rate during a time period when a drive shaft of the device is not rotating. A first control is activated to increase a rate of the fluid flow and second control is activated to initiate a rotation of the drive shaft during another time period when the fluid flow is at the increased rate.

相关附图

血管旋磨器械技术分析报告

 

结  语

 

目前,对于血管减容装置而言而言,国内已有不少厂家正在进行相关研发和临床试验,不过目前技术依然以Cardiovascular等国外企业为主,不过随着国内重视程度不断提高的情况下,中国公司蓄势待发,在一片被普遍看好的市场中开始暗流涌动,但是随着各个“卡脖子”技术不断攻克,国产血管减容装置一定会在近几年实现重大突破和问世。

 

目前,国内各大血管减容装置领域医疗厂商还会将Cardiovascular等重要竞品作为标杆和对照,但是随着各大国内厂商联动产学研医生多方力量,不断创新,必将推动血管减容装置业更智能化、精准化的发展,也会逐步摆脱国外竞品带来的压力和技术障碍,不过,国外巨头公司和国内新兴企业在知识产权方面布局更加紧密,血管减容装置赛道上的各个国内厂商之间的竞争也会逐渐激烈,届时相关知识产权问题也必将会成为各大血管减容装置厂商的研究重点课题,后续相关产品的的研发和专利事务值得持续关注。

 
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来源:医械知识产权