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嘉峪檢測(cè)網(wǎng) 2022-08-18 11:54
前言導(dǎo)讀
血管鈣化（vascular calcification）是動(dòng)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(dòng)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(huì)導(dǎo)致血管壁變硬，順應(yīng)性降低。根據(jù)《冠狀動(dòng)脈鈣化病變?cè)\治中國(guó)專家共識(shí)（2021版）》，冠狀動(dòng)脈鈣化隨年齡增加而增加。此外，外周動(dòng)脈的鈣化也是常見(jiàn)問(wèn)題。無(wú)論是冠狀動(dòng)脈還是外周動(dòng)脈的鈣化，都是介入治療中非常棘手的病變。
對(duì)于血管鈣化疾病，血管減容裝置的出現(xiàn)為冠脈、外周動(dòng)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(dòng)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(jiàn)，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(chǎng)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(jiǎn)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(shì)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(kāi)發(fā)和商業(yè)化。它為外周和冠狀動(dòng)脈的商業(yè)應(yīng)用提供動(dòng)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(guó)明尼蘇達(dá)州圣保羅。
Cardiovascular Systems, Inc為了有效治療血管鈣化病，開(kāi)發(fā)出兩款血管鈣化旋切系統(tǒng)--Diamondback 360，分別適用于外周動(dòng)脈疾?。≒AD）與冠狀動(dòng)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(dòng)力來(lái)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(duì)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(kāi)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(kāi)/公告號(hào) |
US10299820B2 |
申請(qǐng)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(wèn)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(kāi)/公告號(hào) |
US7174240B2 |
申請(qǐng)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(wèn)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(yǔ)
目前，對(duì)于血管減容裝置而言而言，國(guó)內(nèi)已有不少?gòu)S家正在進(jìn)行相關(guān)研發(fā)和臨床試驗(yàn)，不過(guò)目前技術(shù)依然以Cardiovascular等國(guó)外企業(yè)為主，不過(guò)隨著國(guó)內(nèi)重視程度不斷提高的情況下，中國(guó)公司蓄勢(shì)待發(fā)，在一片被普遍看好的市場(chǎng)中開(kāi)始暗流涌動(dòng)，但是隨著各個(gè)“卡脖子”技術(shù)不斷攻克，國(guó)產(chǎn)血管減容裝置一定會(huì)在近幾年實(shí)現(xiàn)重大突破和問(wèn)世。
目前，國(guó)內(nèi)各大血管減容裝置領(lǐng)域醫(yī)療廠商還會(huì)將Cardiovascular等重要競(jìng)品作為標(biāo)桿和對(duì)照，但是隨著各大國(guó)內(nèi)廠商聯(lián)動(dòng)產(chǎn)學(xué)研醫(yī)生多方力量，不斷創(chuàng)新，必將推動(dòng)血管減容裝置業(yè)更智能化、精準(zhǔn)化的發(fā)展，也會(huì)逐步擺脫國(guó)外競(jìng)品帶來(lái)的壓力和技術(shù)障礙，不過(guò)，國(guó)外巨頭公司和國(guó)內(nèi)新興企業(yè)在知識(shí)產(chǎn)權(quán)方面布局更加緊密，血管減容裝置賽道上的各個(gè)國(guó)內(nèi)廠商之間的競(jìng)爭(zhēng)也會(huì)逐漸激烈，屆時(shí)相關(guān)知識(shí)產(chǎn)權(quán)問(wèn)題也必將會(huì)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(lái)源：醫(yī)械知識(shí)產(chǎn)權(quán)
