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血管旋磨器械技術(shù)分析報(bào)告

嘉峪檢測網(wǎng)        2022-08-18 11:54

前言導(dǎo)讀

 

血管鈣化(vascular calcification)是動脈粥樣硬化、高血壓、糖尿病血管病變、血管損傷、慢性腎病和衰老等普遍存在的共同的病理表現(xiàn)。

 

主要表現(xiàn)為血管壁僵硬性增加,順應(yīng)性降低,易導(dǎo)致心肌缺血、左心室肥大和心力衰竭,引發(fā)血栓形成、斑塊破裂,是心腦血管疾病高發(fā)病率和高死亡率的重要因素之一;亦是動脈粥樣硬化心血管事件、腦卒中和外周血管病發(fā)生的重要標(biāo)志分子。

 

血管鈣化是指鈣質(zhì)物沉積在血管壁的一種病變,會導(dǎo)致血管壁變硬,順應(yīng)性降低。根據(jù)《冠狀動脈鈣化病變診治中國專家共識(2021版)》,冠狀動脈鈣化隨年齡增加而增加。此外,外周動脈的鈣化也是常見問題。無論是冠狀動脈還是外周動脈的鈣化,都是介入治療中非常棘手的病變。

 

對于血管鈣化疾病,血管減容裝置的出現(xiàn)為冠脈、外周動脈疾病的治療提供了新思路。

 

血管減容裝置是旨在切除、剃除或汽化動脈粥樣硬化或鈣化斑塊的斑塊切除術(shù)設(shè)備:一般可以包括定向斑塊切除裝置、螺旋斑塊切除系統(tǒng)、激光斑塊切除裝置、機(jī)械切栓術(shù)幾種技術(shù)方向,其中的定向斑塊切除裝置最為常見,也是較為關(guān)注的領(lǐng)域之一,其主要包括括斑塊旋磨(rotational Atherecto-my,RA)、斑塊旋切(directional atherecto-my,DA)兩種類型。

 

目前血管減容裝置市場基本被以美敦力(Medtronic)、CSI(Cardiovascular Systems, Inc(CSI)為代表的外資企業(yè)所壟斷,如CSI的DIAMONDBACK360斑塊旋磨產(chǎn)品就是典型代表。

 

Diamondback360 簡介

                      

全球范圍內(nèi),Cardiovascular Systems, Inc(CSI)在外周、冠脈血管旋磨領(lǐng)域占據(jù)優(yōu)勢地位。

 

Cardiovascular Systems是一家醫(yī)療設(shè)備公司,從事血管和冠心病治療解決方案的開發(fā)和商業(yè)化。它為外周和冠狀動脈的商業(yè)應(yīng)用提供動脈粥樣硬化切除系統(tǒng)。該公司成立于1989年,總部設(shè)在美國明尼蘇達(dá)州圣保羅。

 

Cardiovascular Systems, Inc為了有效治療血管鈣化病,開發(fā)出兩款血管鈣化旋切系統(tǒng)--Diamondback 360,分別適用于外周動脈疾?。≒AD)與冠狀動脈疾?。–AD)。

 

技術(shù)概覽

                         

以CAD版Diamondback 360為例,DIAMONDBACK360系統(tǒng)的主要組成部分可參照如下附圖。

 

Diamondback結(jié)合不同的打磨和脈動力來治療鈣化形態(tài),根據(jù)不同的產(chǎn)品類型,包括結(jié)節(jié)、偏心(不規(guī)則)和同心(環(huán)形)。該設(shè)備還具有GlideAssist功能,該功能可以跟蹤,更輕松地移除設(shè)備并重新放置,尤其是在具有挑戰(zhàn)性的解剖結(jié)構(gòu)中,可以更順暢地重新放置。

 

以PAD版Diamondback 360為例,DIAMONDBACK360系統(tǒng)技術(shù)相關(guān)產(chǎn)品的結(jié)構(gòu)組成和工作原理可參考如下視頻:

 

專利概覽

                       

筆者對Diamondback的相關(guān)專利根據(jù)類別分別進(jìn)行了整理和剖析,這里筆者從眾多專利中選擇了若干進(jìn)行了解析,相關(guān)相關(guān)結(jié)果如下:Diamondback的完整專利清單和分析筆者也已開展完成,如感興趣可以與筆者取得聯(lián)系,共同交流學(xué)習(xí):

 

公開/公告號

US10299820B2

申請日

2016-02-18

發(fā)明名稱

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

解決的技術(shù)問題

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.

技術(shù)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.

相關(guān)附圖

血管旋磨器械技術(shù)分析報(bào)告         

 

公開/公告號

US7174240B2

申請日

2002-10-16

發(fā)明名稱

Control system for rotational angioplasty device

解決的技術(shù)問題

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.

技術(shù)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.

相關(guān)附圖

血管旋磨器械技術(shù)分析報(bào)告

 

結(jié)  語

 

目前,對于血管減容裝置而言而言,國內(nèi)已有不少廠家正在進(jìn)行相關(guān)研發(fā)和臨床試驗(yàn),不過目前技術(shù)依然以Cardiovascular等國外企業(yè)為主,不過隨著國內(nèi)重視程度不斷提高的情況下,中國公司蓄勢待發(fā),在一片被普遍看好的市場中開始暗流涌動,但是隨著各個“卡脖子”技術(shù)不斷攻克,國產(chǎn)血管減容裝置一定會在近幾年實(shí)現(xiàn)重大突破和問世。

 

目前,國內(nèi)各大血管減容裝置領(lǐng)域醫(yī)療廠商還會將Cardiovascular等重要競品作為標(biāo)桿和對照,但是隨著各大國內(nèi)廠商聯(lián)動產(chǎn)學(xué)研醫(yī)生多方力量,不斷創(chuàng)新,必將推動血管減容裝置業(yè)更智能化、精準(zhǔn)化的發(fā)展,也會逐步擺脫國外競品帶來的壓力和技術(shù)障礙,不過,國外巨頭公司和國內(nèi)新興企業(yè)在知識產(chǎn)權(quán)方面布局更加緊密,血管減容裝置賽道上的各個國內(nèi)廠商之間的競爭也會逐漸激烈,屆時(shí)相關(guān)知識產(chǎn)權(quán)問題也必將會成為各大血管減容裝置廠商的研究重點(diǎn)課題,后續(xù)相關(guān)產(chǎn)品的的研發(fā)和專利事務(wù)值得持續(xù)關(guān)注。

 
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