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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):
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公開/公告號 |
US10299820B2 |
申請日 |
2016-02-18 |
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發(fā)明名稱 |
Methods and systems for disrupting calcified walls of biological conduits and calcified lesions therein |
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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. |
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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. |
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相關(guān)附圖 |
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公開/公告號 |
US7174240B2 |
申請日 |
2002-10-16 |
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發(fā)明名稱 |
Control system for rotational angioplasty device |
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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. |
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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. |
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相關(guān)附圖 |
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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。

來源:醫(yī)械知識產(chǎn)權(quán)