TWI513451B - 用於神經調節治療之估算及反饋的裝置、系統及方法 - Google Patents
用於神經調節治療之估算及反饋的裝置、系統及方法 Download PDFInfo
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Description
本申請案主張以下申請中之申請案的權益:(a)美國臨時申請案第61/406,531號,申請於2010年10月25日;(b)美國臨時申請案第61/528,108號,申請於2011年8月26日;(c)美國臨時申請案第61/528,091號,申請於2011年8月26日;及(d)美國臨時申請案第61/528,684號,申請於2011年8月29日。
所有以上申請案均以全文引用的方式併入本文中。另外,以引用的方式併入本文中之申請案中所揭示之實施例的組分及特徵可與本申請案中揭示及主張之各種組分及特徵組合。
本發明係關於神經調節治療,且更特定言之係關於用於向提供神經調節治療之裝置的操作者提供估算及反饋的裝置、系統及方法。
交感神經系統(SNS)為通常與壓迫反應相關之主要非自主身體控制系統。SNS之纖維神經支配人類身體幾乎每一器官系統中之組織且可影響諸如瞳孔直徑、腸動力及尿排出量之特徵。該調節作用可適用於維持動態平衡或為身體對環境因素作出快速反應做好準備。然而,SNS之慢性活化為一種常見的不適反應,其可驅使許多疾病病況發展。尤其已在實驗上且在人類中確定腎SNS過度活化可能導致高血壓、容量負荷過重狀態(諸如心臟衰竭)及進行性腎病之複雜病理生理學。舉例而言,放射性示蹤劑稀釋已表明原發性高血壓患者體內腎臟去甲腎上腺素(NE)溢出率增加。
心-腎交感神經亢進在心臟衰竭患者體內尤為顯著。舉例而言,在該等患者體內常可見自心臟及腎臟至血漿之NE溢出加重。增強之SNS活化通常為慢性及晚期腎病之特徵。在晚期腎病患者中,已表明高於中值之NE血漿含量預示心血管疾病且為死亡之若干原因。對於糖尿病或造影劑腎病變患者而言亦為如此。有證據表明,源自病變腎臟之感覺傳入信號為引發及維持高中樞交感神經流出的主要因素。
神經支配腎臟之交感神經終止於血管、近腎小球器及腎小管中。刺激腎交感神經可導致腎素釋放增加、鈉(Na+
)再吸收增加及腎血流量減少。腎功能之該等神經調節組分在特徵為交感神經張力升高之疾病病況中大大受刺激,且可能導致高血壓患者之血壓增加。腎血流量及腎小球濾過率由於腎交感神經傳出刺激而減少可能成為心-腎症候群中腎功能喪失(亦即作為慢性心臟衰竭之進行性併發症的腎功能障礙)之基礎。阻止腎傳出交感神經刺激後果之藥理學策略包括作用於中樞神經之抑交感神經作用藥物、β阻斷劑(欲減少腎素釋放)、血管收縮素轉化酶抑制劑及受體阻斷劑(欲阻斷由腎素釋放所引起之血管收縮素II作用及醛固酮活化)以及利尿劑(欲對抗腎交感神經介導之鈉及水滯留)。然而,該等藥理學策略具有顯著侷限性,包括功效有限、適應性問題、副作用及其他限制。因此,公共衛生強烈需要替代性治療策略。
本發明之技術一般關於用於為執行程序(諸如電及/或熱誘導之腎神經調節(亦即致使神經支配腎臟之神經纖維為惰性或失活或以其他方式使其功能完全或部分減少))之臨床醫師或其他從業者提供適用估算及反饋的裝置、系統及方法。舉例而言,在一實施例中,反饋涉及完全治療,且尤其涉及對治療在技術上成功之可能性的評估。在某些實施例中,可基於定義之標準來分析在治療過程期間監測之一或多個參數(諸如與溫度、阻抗、血管收縮、心跳速率、血流量及/或患者運動相關之參數)。基於該分析,可為操作者指示基於治療技術成功可能性之治療可接受性或缺乏可接受性。
在其他實施例中,可為操作者提供關於無法完成之治療(諸如由於與超過預定及/或計算臨限值之溫度或阻抗相關之監測值或經測定超出預定及/或計算範圍之值而中斷之程序)的反饋及/或指令。在該等實施例中,可基於定義之標準來分析在不完全治療過程期間監測之一或多個參數(諸如與溫度、阻抗及/或患者運動相關之參數)。基於該分析,可為操作者提供其他指令或反饋,諸如是否應對治療部位成像以評估治療裝置是否無意中移動,或是否可進行其他治療嘗試等。
下文參考圖1至14B描述本技術若干實施例之具體細節。儘管下文描述關於用以估算神經調節治療之裝置、系統及方法的諸多實施例,但除本文所述以外之其他應用及其他實施例亦在本技術之範疇內。另外,本技術之若干其他實施例可具有與本文所述不同之組態、組分或程序。因此,一般技術者將相應瞭解本技術可具有含其他要素之其他實施例,或本技術可具有無下文參考圖1至14B所示及所述之若干特徵的其他實施例。
術語「遠端」及「近端」在下文描述中係關於相對於治療臨床醫師之位置或方向使用。「遠端」為遠離臨床醫師或在遠離臨床醫師方向上之位置。「近端」為靠近臨床醫師或在朝向臨床醫師方向上之位置。
I.腎神經調節
腎神經調節使神經支配腎臟之神經部分或完全喪失能力或以其他方式進行有效破壞。特定而言,腎神經調節包含抑制、減少及/或阻斷沿神經支配腎臟之神經纖維(亦即傳出及/或傳入神經纖維)的神經通信。喪失能力可為長期(例如永久性或歷時數月、數年或數十年之時間)或短期的(例如歷時數分鐘、數小時、數天或數週之時間)。預期腎神經調節可有效治療特徵為總體交感神經活性增加之若干臨床病狀,且尤其為與經刺激之中樞交感神經相關聯之病狀,諸如高血壓、心臟衰竭、急性心肌梗塞、代謝症候群、胰島素抗性、糖尿病、左心室肥大、慢性及晚期腎病、心臟衰竭中之不當體液滯留、心-腎症候群及猝死。傳入神經信號減少會導致交感神經張力/傳動全身性減少,且預期腎神經調節適用於治療與全身性交感神過度活性或亢進相關聯之若干病狀。腎神經調節可潛在地有益於受交感神經神經支配之各種器官及身體結構。舉例而言,中樞交感神經傳動減少可降低折磨代謝症候群及II型糖尿病患者之胰島素抗性。另外,骨質疏鬆症可由交感神經活化且可得益於伴隨腎神經調節之交感神經傳動下調。下文第IV部分中提供相關患者解剖學及生理學之更詳細描述。
可使用各種技術使神經路徑(諸如神經支配腎臟之神經路徑)部分或完全喪失能力。能量(例如電能、熱能)藉由能量傳遞元件有目的地應用於組織可誘發腎動脈局部區域及腎叢RP相鄰區域(緊密地位於腎動脈外膜內或與其相鄰)上的一或多種所要熱加熱效應。有目的地應用熱加熱效應可沿整個腎叢RP或其一部分達成神經調節作用。
熱加熱效應可包括熱消融與非消融熱改變或損壞兩者(例如經由持續加熱及/或電阻加熱)。所要熱加熱效應可包括將目標神經纖維之溫度升高至所要臨限值以上以達成非消融熱改變,或升高至更高溫度以上以達成消融熱改變。舉例而言,對於非消融熱改變而言目標溫度可高於體溫(例如約37℃)但小於約45℃,或對於消融熱改變而言目標溫度可為約45℃或更高。
更特定而言,暴露於超過約37℃體溫但低於約45℃溫度之熱能(熱)可經由適度加熱目標神經纖維或灌注目標纖維之血管結構而誘發熱改變。在血管結構受影響之情況下,目標神經纖維拒絕灌注,導致神經組織壞死。舉例而言,此可誘發纖維或結構之非消融熱改變。暴露於高於約45℃溫度或高於約60℃之熱可經由實質上加熱纖維或結構而誘發熱改變。舉例而言,該等較高溫度可熱消融目標神經纖維或血管結構。在某些患者中,可能需要達到使目標神經纖維或血管結構熱消融、但小於約90℃或小於約85℃或小於約80℃及/或小於約75℃之溫度。無論用以誘發熱神經調節之熱暴露類型如何,均希望腎交感神經活性(「RSNA」)減小。下文第IV部分中提供相關患者解剖學及生理學之更詳細描述。
II.腎神經調節之系統及方法
圖1說明根據本發明技術之一實施例組態之腎神經調節系統10(「系統10」)。系統10包括可操作地耦接至能源或能量產生器26之血管內治療裝置12。在圖1所示之實施例中,治療裝置12(例如導管)包括一細長軸16,該細長軸16具有一近端部分18、一位於近端部分18之近端區域的手柄總成34及一相對於近端部分18向遠端延伸之遠端部分20。治療裝置12進一步包括一治療總成或治療區22,其包括一位於軸16之遠端部分20處或靠近其之能量傳遞元件24(例如電極)。在所說明之實施例中,第二能量傳遞元件24以虛線說明以表明本文所揭示之系統及方法可與具有一或多個能量傳遞元件24之治療裝置一起使用。另外,將瞭解儘管僅展示兩個能量傳遞元件24,但治療裝置12可包括其他能量傳遞元件24。
能量產生器26(例如RF能量產生器)經組態以產生所選形式及量值之能量,經由能量傳遞元件24傳遞至目標治療部位。能量產生器26可經由電纜28電耦接至治療裝置12。至少一根電源線(未展示)沿細長軸16或通過細長軸16中之內腔至能量傳遞元件24且輸送治療能量至能量傳遞元件24。控制機構(諸如腳踏板32)可連接(氣動連接或電連接)至能量產生器26以使得操作者可起始、終止及視情況調整能量產生器之各種操作特徵,包括(但不限於)功率傳遞。能量產生器26可經組態以經由自動控制演算法30及/或在臨床醫師控制下傳遞治療能量。另外,可對系統10之處理器執行一或多種估算/反饋演算法31。該等估算/反饋演算法31在結合治療操作執行時可諸如經由與系統10相關聯之顯示器33為系統10之使用者提供反饋。反饋或估算可使系統10之操作者能確定給定治療之成功性及/或估算可能失敗條件。因此,該反饋可用於幫助操作者學習在進行治療時如何增加成功可能性。下文參考圖3至10B描述關於適合控制演算法30及估算/反饋演算法31的其他詳情。
在某些實施例中,系統10可經組態以經由能量傳遞元件24提供單極電場傳遞。在該等實施例中,中性或分散電極38可電連接至能量產生器26且附接至患者外部(如圖2中所示)。另外,一或多個感應器(未展示),諸如一或多個溫度(例如熱電偶、熱敏電阻等)、阻抗、壓力、光學、流量、化學或其他感應器,可位於接近能量傳遞元件24處或其內部且連接至一或多根電源線(未展示)。舉例而言,總計可包括兩根電源線,其中兩根線均可自感應器輸送信號,且一根線可用於達成雙重目的且亦可將能量傳送至能量傳遞元件24。或者,兩根線均可將能量輸送至能量傳遞元件24。
在包括多個能量傳遞元件24之實施例中,能量傳遞元件24可獨立地同時、選擇性或相繼傳遞功率(亦即可以單極方式使用),及/或可在任何所要元件組合之間傳遞功率(亦即可以雙極方式使用)。此外,必要時,視情況可允許臨床醫師選擇使用何種能量傳遞元件24進行功率傳遞以在腎動脈內形成高度定製之損害。
在上面實施系統10之計算裝置可包括中央處理器、記憶體、輸入裝置(例如鍵盤及指向裝置)、輸出裝置(例如顯示裝置)及儲存裝置(例如磁碟機)。輸出裝置可經組態以與治療裝置12通信(例如經由電纜28),從而控制到達能量傳遞元件24之功率及/或自能量傳遞元件24或任何相關聯之感應器獲得信號。顯示裝置可經組態以提供關於功率位準或感應器資料之指示(諸如音訊、視覺或其他指示),或可經組態以將資訊傳達至另一裝置。
記憶體及儲存裝置為可由實施目標權限實施系統之電腦可執行指令編碼之電腦可讀媒體,其意謂含有該等指令之電腦可讀媒體。另外,指令、資料結構及訊息結構可經儲存或經由資料輸送媒體(諸如通信鏈路上之信號)輸送且可經加密。可使用各種通信鏈路,諸如網際網路、局域網路、廣域網路、點對點撥號連接、行動電話網路等等。
系統10之實施例可在各種操作環境中實施及使用,包括個人電腦、伺服電腦、手持型或膝上型裝置、多處理器系統、基於微處理器之系統、可程式化消費型電子產品、數位攝影機、網路PC、小型電腦、大型電腦、包括任何以上系統或裝置之計算環境等。
系統10可描述於由一或多個電腦或其他裝置執行之電腦可執行指令(諸如程式模組)的一般背景下。程式模組一般包括執行特定任務或實施特定抽象資料類型之常式、程式、對象、組件、資料結構等。程式模組之功能在各種實施例中視需要通常可組合或分配。
圖2(且參考圖12)說明用系統10之一實施例調節腎神經。治療裝置12經由血管內路徑進入腎叢RP,諸如自股(如說明)、臂、橈或腋動脈中之經皮進入部位至各自腎動脈RA內之目標治療部位。如所說明,軸16之近端部分18之一部分暴露於患者外部。藉由自血管內路徑外部操縱軸16之近端部分18(例如經由手柄總成34),臨床醫師可使軸16經由有時彎曲之血管內路徑前進且遠端操縱或致動軸遠端部分20。影像引導,例如電腦斷層攝影(CT)、螢光透視、血管內超音波(IVUS)、光學相干斷層攝影(OCT)或另一適合引導模態或其組合可用以幫助臨床醫師進行操縱。另外,在某些實施例中,影像引導組件(例如IVUS、OCT)可併入治療裝置12本身中。一旦在各自腎動脈內,能量傳遞元件24與組織之間接近、對準及接觸,則藉由能量傳遞元件24將來自能量產生器26之能量有目的地應用於組織將在腎動脈之局部區域及腎叢RP之相鄰區域(緊密地位於腎動脈外膜內、與其相鄰或緊密接近)上誘發一或多種所要神經調節效應。有目的地應用能量可沿整個腎叢RP或其一部分達成神經調節作用。
神經調節效應一般至少部分地隨功率、時間、能量傳遞元件24與血管壁之間的接觸及流經血管之血流量而變化。神經調節效應可包括去神經支配、熱消融及非消融熱改變或損壞(例如經由持續加熱及/或電阻加熱)。所要熱加熱效應可包括將目標神經纖維之溫度升高至所要臨限值以上以達成非消融熱改變,或升高至更高溫度以上以達成消融熱改變。舉例而言,對於非消融熱改變而言目標溫度可高於體溫(例如約37℃)但小於約45℃,或對於消融熱改變而言目標溫度可為約45℃或更高。所要非熱神經調節效應可包括改變神經中輸送之電信號。
III.估算治療及反饋
A.綜述
在一實施例中,使用系統10投與之治療包括經由一或多個能量傳遞元件(例如電極)向腎動脈內壁傳遞能量,歷時預定時間量(例如120秒)。可對左及右腎動脈投與多次治療(例如4至6次)以達成所要覆蓋範圍。舉例而言,治療之技術目標可為將至少約3 mm深度之組織加熱至將損害神經之溫度(例如約65℃)。該程序之臨床目標為神經調節(例如損害)足夠數量之腎神經(交感神經腎叢之傳出或傳入神經)以使交感神經張力減少。若達成治療之技術目標(例如將約3 mm深度之組織加熱至約65℃),則形成腎神經組織損害之機率高。技術上成功治療之次數愈多,調節足夠比例腎神經之機率愈大,因此臨床成功之機率愈大。
在整個治療期間,可存在多種狀態指示治療不成功之可能性。在某些實施例中,基於該等狀態之指示,可停止或修改系統10之操作。舉例而言,某些指示可導致能量傳遞中斷且諸如在顯示器33上可顯示適當訊息。可產生顯示訊息及/或導致治療方案中斷或修改的因素包括(但不限於)指示超出可接受或預期臨限值及/或可預定或計算之範圍的阻抗、血流量及/或溫度量測值或變化。訊息可指示諸如患者病狀類型(例如異常患者病狀)、超出可接受或預期臨限值之參數類型及/或值、對臨床醫師之建議動作的指示或能量傳遞已停止之指示的資訊。然而,若未觀察到非預期或異常量測值,可繼續根據程式化概況在目標部位處傳遞能量歷時指定持續時間,達成完全治療。在完全治療之後,停止能量傳遞且可顯示指示治療完成之訊息。
然而,可在不起始指示異常患者病狀之情況下完成治療,然而,可能發生改變(例如降低)技術上成功治療之機率的事件或事件組合。舉例而言,傳遞能量之電極可能移動或無意中置放在電極與腎動脈壁之間的不充分接觸處,藉此導致損害深度或溫度不足。因此,即使在未指示異常患者病狀之情形下完成治療,仍可能難以估算治療之技術成功性。同樣,在異常患者病狀之指示可由系統10報導的程度上,可能難以瞭解異常患者病狀之原因(諸如在預期範圍以外之溫度及/或阻抗值)。
如上文所述,可提供在系統10之基於處理器之組件(諸如與產生器26一起提供之一或多個組件)上執行的一或多種估算/反饋演算法31。在該等實施例中,該一或多種估算/反饋演算法31能夠為使用者提供有意義之反饋,此反饋可用於估算給定治療及/或可用於瞭解某些類型異常患者病狀之意義及如何減少該等病狀發生率。舉例而言,若特定參數(例如阻抗或溫度值)引起或指示治療未如預期進行且(在某些情況下)可導致技術上不成功之治療,則系統10可提供反饋(例如經由顯示器33)以警示臨床醫師。對臨床醫師之警示範圍可為對不成功治療之簡單通知至在後續治療中修改特定治療參數(例如治療期間之阻抗值、能量傳遞元件24在患者體內之置放等)的建議。系統10可因此自完全治療循環獲得知識且基於該知識修改後續治療參數以改良功效。該一或多種估算/反饋演算法31可考慮之量測值的非詳盡實例包括關於以下之量測值:指定時間內之溫度變化、最大溫度、最大平均溫度、最小溫度、在預定或計算時間相對於預定或計算溫度之溫度、指定時間內之平均溫度、最大血流量、最小血流量、在預定或計算時間相對於預定或計算血流量之血流量、隨時間之平均血流量、最大阻抗、最小阻抗、在預定或計算時間相對於預定或計算阻抗之阻抗、指定時間內之阻抗變化或指定時間內相對於溫度變化之阻抗變化。可在一或多個預定時間、時間範圍、計算時間及/或量測事件發生時或相對於其發生時之時間進行量測。將瞭解,以上清單僅提供大量不同量測值之實例,且可使用其他適合量測值。
B.控制所應用之能量
使用本文揭示之治療向目標組織傳遞療法,可有益於能量以控制方式傳遞至目標神經結構。控制之能量傳遞將使熱治療區能夠延伸至腎筋膜內,同時減少對血管壁之不利能量傳遞或熱效應。控制之能量傳遞亦可達成更一致、可預測且有效之總體治療。因此,產生器26理想地包括處理器,該處理器包括具有用於執行演算法30(參見圖1)之指令的記憶體組件以控制功率及能量傳遞至能量傳遞裝置。演算法30(其代表性實施例描繪於圖3中)可作為由耦接至產生器26之處理器執行之習知電腦程式來實施。使用逐步指令之臨床醫師亦可手動實施演算法30。
根據演算法監測之操作參數可包括例如溫度、時間、阻抗、功率、血流量、流動速度、體積流動速率、血壓、心跳速率等。溫度之離散值可用於觸發功率或能量傳遞之變化。舉例而言,高溫度值(例如85℃)可指示組織脫水,在此情形下演算法可減少或停止功率及能量傳遞以防止對目標或非目標組織之不良熱效應。或者或另外,可使用時間來防止對非目標組織之不良熱改變。對於每一治療而言,檢查設定時間(例如2分鐘)以防止不定之功率傳遞。
可使用阻抗來量測組織變化。阻抗指示治療部位之電特性。在熱誘發實施例中,當對治療部位施加電場時,隨著組織細胞對電流之電阻變小,阻抗將減小。若施加過多能量,則電極附近可能發生組織脫水或凝固,隨著細胞損失保水性及/或電極表面積減少(例如經由凝固物積聚),將增加阻抗。因此,組織阻抗增加可指示或預示對目標或非目標組織之不良熱改變。在其他實施例中,可使用阻抗值來評估能量傳遞元件24與組織之接觸。對於多電極組態(例如當能量傳遞元件24包括兩個或兩個以上電極時)而言,個別電極阻抗值之間的相對小差異可指示與組織之接觸良好。對於單電極組態而言,穩定值可指示接觸良好。因此,來自該一或多個電極之阻抗資訊可提供給下游監測者,繼而可為臨床醫師提供關於與組織接觸之能量傳遞元件24之品質的指示。
或者或另外,功率為控制療法傳遞中之有效監測參數。功率為電壓與電流之函數。演算法30可修改電壓及/或電流以達成所要功率。
亦可使用前述參數之導數(例如變化速率)來觸發功率或能量傳遞之變化。舉例而言,可監測溫度之變化速率以使得在偵測到溫度突然升高之情況下減少功率輸出。同樣,可監測阻抗之變化速率以使得在偵測到阻抗突然升高之情況下減少功率輸出。
如圖3中可見,當臨床醫師起始治療(例如經由圖1中說明之腳踏板32)時,控制演算法30包括對產生器26之指令以在第一時間段t1
(例如15秒)內將其功率輸出逐漸調整至第一功率位準P1
(例如5瓦特(watt))。第一時間段期間之功率增加通常為線性的。因此,產生器26以P1
/t1
之一般恆定速率增加其功率輸出。或者,功率增加可為非線性的(例如呈指數或呈抛物線),具有可變增加速率。一旦達到P1
及t1
,則演算法可保持在P1
,直至新時間t2
,歷時預定時間段t2
-t1
(例如3秒)。在t2
,功率在預定時間段t3
-t2
(例如1秒)內以預定增量(例如1瓦特)增加至P2
。預定時間段內約1瓦特之預定增量的此功率上升可持續,直至達到最大功率PMAX
或滿足某些其他條件。在一實施例中,PMAX
為8瓦特。在另一實施例中,PMAX
為10瓦特。視情況功率可維持在最大功率PMAX
,歷時所要時間段或長達所要總治療時間(例如長達約120秒)。
在圖3中,演算法30例示性地包括功率控制演算法。然而,應瞭解演算法30或者可包括溫度控制演算法。舉例而言,功率可逐漸增加,直至獲得所要溫度達所要持續時間。在另一實施例中,可提供功率控制與溫度控制演算法之組合。
如所論述,演算法30包括監測某些操作參數(例如溫度、時間、阻抗、功率、流動速度、體積流動速率、血壓、心跳速率等)。該等操作參數可連續或週期性地監測。演算法30針對預定參數概況檢查所監測參數以確定該等參數個別或組合是否在預定參數概況所設定之範圍內。若所監測參數在預定參數概況所設定之範圍內,則可以命令之功率輸出繼續治療。若所監測參數不在預定參數概況所設定之範圍內,則演算法30相應調整命令之功率輸出。舉例而言,若達到目標溫度(例如65℃),則功率傳遞保持恆定,直至總治療時間(例如120秒)期滿。若達到或超過第一溫度臨限值(例如70℃),則以預定增量(例如0.5瓦特、1.0瓦特等)減少功率,直至達到目標溫度。若達到或超過第二功率臨限值(例如85℃),藉此指示不良病狀,則可終止功率傳遞。系統可裝配各種可聽及可視警報以警示某些病狀之操作者。
以下為演算法30可調整及/或終止/中斷命令之功率輸出之情況的非詳盡清單:
(1)所量測溫度超過最大溫度臨限值(例如約70℃至約85℃)。
(2)源自所量測溫度之平均溫度超過平均溫度臨限值(例如約65℃)。
(3)所量測溫度之變化速率超過變化速率臨限值。
(4)當產生器26具有非零輸出時,一定時間段內之溫度升高低於最小溫度變化臨限值。能量傳遞元件24與動脈壁之間之不良接觸可導致此類狀況。
(5)所量測阻抗超過或超出阻抗臨限值(例如<20歐姆(Ohm)或>500歐姆)。
(6)所量測阻抗超過相對臨限值(例如阻抗自起始或基線值減小,隨後升高至該基線值以上)。
(7)所量測功率超過功率臨限值(例如>8瓦特或>10瓦特)。
(8)所量測功率傳遞持續時間超過時間臨限值(例如>120秒)。
例如與電生理學治療中用以達成心臟組織消融之功率位準(例如大於約15瓦特、大於約30瓦特等之功率位準)相比,在根據本發明技術之腎神經調節治療期間傳遞之最大功率量值宜相對較低(例如小於約15瓦特、小於約10瓦特、小於約8瓦特等)。由於可使用相對低之功率位準來達成該腎神經調節作用,因此在功率傳遞期間將能量傳遞元件及/或非目標組織維持在所要溫度或所要溫度以下(例如在約50℃或50℃以下,例如或在約45℃或45℃以下)所需之血管內注射液的流動速率及/或總體積亦可相對低於例如在電生理學治療中使用之較高功率位準(例如高於約15瓦特之功率位準)下所要求之值。在使用主動冷卻之實施例中,血管內輸注液之流動速率及/或總體積之相對減少有利地促使在禁忌使用較高功率位準,因此相應較高輸液速率/體積之較高風險患者群組(例如患有心臟病、心臟衰竭、腎功能不全及/或糖尿病之患者)中使用血管內輸液。
C.治療之技術估算
圖4為根據本發明技術之一實施例組態之治療演算法80的方塊圖。演算法80經組態以估算治療中之事件、確定治療技術成功之機率及顯示訊息,由此為系統10(或另一適合治療系統)之操作者提供反饋。若確定治療具有次最佳技術成功之預定機率,則可顯示指示治療未如預期進行之訊息。替代實施例可將治療分類為若干範圍之成功機率,諸如1至5級之成功機率。類似地,在某些實施例中,演算法80可估算治療是否屬於高成功機率類、極低成功機率類或介於其間之某一類。
作為治療特徵且可由演算法80用於估算治療之變數包括(但不限於):時間(亦即治療持續時間)、功率、溫度變化、最大溫度、平均溫度、血流量、溫度或阻抗之標準偏差、阻抗變化或該等或其他變數之組合。舉例而言,某些或所有該等變數可提供給演算法80作為治療資料82。在演算法80之該概括性描述中,治療資料80可基於標準84之不同分類或程度的級別或級數來評估。根據標準84之一對治療資料82進行有利評估可導致顯示(區塊86)指示治療可接受或成功之訊息。根據標準84發現治療資料82不可接受可導致治療資料進入下一估算標準84。
在所述實施例中,根據所有標準84發現治療資料均不可接受可導致執行其他估算,諸如所述之分析及計分步驟88。可估算分析及計分步驟之輸出(例如分值90)(區塊92)。基於該估算92,治療可認為可接受,且顯示相應螢幕(區塊86);或不可接受,且顯示指示治療未如預期進行之螢幕94。在其他實施例中,演算法80可包括對治療未如預期進行之指示做出反應之自動行為(例如供應給能源之功率位準自動減少)。
圖4描繪治療估算演算法之概括性及簡單實施例,而圖5描繪治療估算演算法100之一實施例的更詳細實例。治療估算演算法100可在可耗時120秒(如所描繪)或某個其他適合之持續時間的完全治療(區塊102)之後且使用在治療過程期間產生之資料及/或量測值進行計算。
在所述實施例中,可能認為當電極與血管壁未緊密接觸時,出現小於理想治療之機率最大。因此,流程圖中之決策區塊104、106、108及110與不同標準相關,且基於在完全治療過程中觀測或量測之資料102,篩檢出似乎具有一或多個在預定範圍以外之標準(亦即不具有高成功機率)的彼等治療。在所述實施例中,在決策區塊104、106、108及110處未篩檢出之彼等治療進入線性判別分析(LDA)112以進一步估算治療。在其他實施例中,可進行其他適合之分析來替代所述LDA。分配給每一步驟之值(亦即由各自標準估算)及LDA中所用之係數114可由自若干治療收集之資料及/或自動物研究獲取之經驗得出。
在所述實施例中,第一決策區塊104藉由檢查在第一個15秒內之平均溫度變化是否大於14℃來估算對能量傳遞之初始溫度反應。在一實施例中,平均溫度係指在短時間量(例如3秒)內之平均值,其基本上濾除由脈動血流引起之高頻率大波動。如所瞭解,治療電極之溫度升高為自組織至電極之傳熱結果。若電極與血管壁未充分接觸,則能量傳遞至在其周圍流動之血液且電極溫度不會增加如此多。謹記此點,若第一個15秒內之平均溫度變化大於例如14℃,則該初始溫度反應可指示充分電極接觸、接觸力及/或血流速率(至少在治療開始時),且若在剩餘治療中未遇到治療未如預期進行之指示,則不存在治療次最佳或技術上不成功之高機率。因此,決策區塊104處之肯定回答導致顯示「治療完成」訊息120。然而,若第一個15秒內之平均溫度變化小於或等於例如14℃,則該初始溫度反應可指示電極與血管壁未充分接觸。因此,決策區塊104處之否定回答導致進入標準106以進一步估算。
在決策區塊106處,藉由檢查最大平均溫度是否大於例如56℃來估算最熱溫度。無論持續時間如何,溫度升高至臨限值位準(例如56℃)以上均足以允許技術成功。因此,高於臨限值之溫度可足以指示成功損害形成,而不管決策區塊104處之初始溫度升高未指示充分接觸。舉例而言,電極初始時可未充分接觸,但隨後可至少接觸足以使血管壁發熱,使得電極內之溫度感應器讀數高於56℃的時間。決策區塊106處之肯定結果導致顯示「治療完成」訊息120。然而,決策區塊106處之否定結果指示最大平均溫度未充分升高。因此,演算法100進入決策區塊108以進一步估算。
在決策區塊108處,估算功率維持其最大量之時間段內的平均溫度(亦即自平均計算值減去上升期)。在一實施例中,該估算由確定45秒至120秒之時間段內,平均即時溫度是否大於53℃組成。以此方式,該標準進行檢查以確定溫度是否在某持續時間內高於臨限值。若決策區塊108作出肯定判別,則不管初始溫度反應及最大平均溫度不足以指示技術成功性(亦即決策區塊104及106失敗),最後75秒內之平均溫度均指示充分接觸足夠時間。舉例而言,可能產生足夠損害,但由於血流自電極吸取高熱量,因此在電極中量測之最大平均溫度不大於56℃。因此,決策區塊108處之肯定結果導致顯示「治療完成」訊息120。然而,決策區塊108處之否定結果指示持續功率階段之平均即時溫度不足且演算法100進入決策區塊110以進一步估算治療。
在決策區塊110處,藉由檢查預定時間段(例如45秒至114秒)內之阻抗變化百分比是否大於初始阻抗之預定值(例如14%)來估算阻抗變化。初始阻抗測定為在治療開始後不久(例如6秒時)之阻抗以消除在此時間段之前阻抗量測值之可能錯讀(例如由於造影劑注射)。如所瞭解,組織對射頻(RF)電流之阻抗隨組織溫度增加而減小,直至組織充分加熱至導致其脫水,此時其阻抗開始上升。因此,組織阻抗減小可指示組織溫度上升。持續功率階段期間之即時阻抗變化百分比可如下計算:
若決策區塊110產生肯定判別,則不管先前三個決策區塊未展示溫度充分上升(亦即決策區塊104、106及108失敗),阻抗變化均可指示組織經充分加熱,但電極中之溫度感應器未充分上升。舉例而言,即使組織經加熱,但極高血流量仍可導致電極溫度維持相對較低。因此,決策區塊110處之肯定結果導致顯示「治療完成」訊息120。然而,決策區塊110處之否定結果導致演算法100進入執行LDA 112。
在LDA 112處,連同每一事件之重要性等級估算事件組合。舉例而言,在所述實施例中,在決策區塊104、106、108、110處估算之標準均包括於LDA 112中。另外,在該實施例中,可包括三個其他標準:(1)平均溫度之標準偏差(其可提供關於由呼吸引起之滑動程度的指示);(2)即時溫度之標準偏差(其可提供關於可變血流量及/或接觸力及/或間斷性接觸之指示);及(3)治療結束時調整之平均阻抗變化(其可進一步表徵阻抗變化且提供關於組織溫度變化之指示)。若該分析確定變數之組合對減少技術成功性具有顯著影響(例如在決策區塊122處LDA分值<0),則顯示「非預期治療」訊息124。否則,顯示「治療完成」訊息120。
應瞭解,上述各種參數僅為與演算法100之一實施例相關之代表性實例,且一或多個該等參數在其他實施例中可變化。此外,上文關於特定治療部分所述之特定值在其他實施例中可基於例如不同裝置組態、電極組態、治療方案等而修改/變化。
如上所述,演算法100經組態以估算治療且顯示指示治療完成或者治療未如預期進行之訊息。基於描述治療估算之訊息,臨床醫師(或使用自動化技術之系統)隨後可決定是否需要進一步治療及/或一或多個參數在後續治療中是否應修改。舉例而言,在上述實例中,演算法100可估算大量一般與電極與血管壁之間的不良接觸有關之情形以有助於確定治療是否次最佳。舉例而言,當電極隨患者呼吸及動脈移動而前後滑動時,當電極在患者移動時移位時,當無意中移動導管時,當導管未偏斜至使電極與血管壁之間充分接觸或有充足接觸力所需之程度時,及/或當電極置放於不穩定位置時,可發生不良接觸。此外,如上文所述,若特定參數或參數組可引起或導致次最佳治療時,系統10(圖1)可提供反饋以警示臨床醫師在後續治療期間修改一或多個治療參數。預期治療之該估算及反饋有助於臨床醫師學習改良其置放技術以獲得更佳接觸且降低技術上不成功治療之頻率。
D.與高溫條件相關之反饋
儘管前文描述治療技術成功性之概括性估算,但可用於系統10(圖1)操作者之另一種反饋形式為與患者或治療病狀之特定類型相關之反饋。舉例而言,系統10可產生與高溫條件相關之訊息。特定而言,在傳遞能量之治療期間,組織溫度可增加至特定位準以上。安置於電極中或其附近之溫度感應器(例如熱電偶、熱敏電阻等)提供關於電極中溫度之指示,且某種程度上提供關於組織溫度之指示。在能量傳遞至組織時電極不直接加熱。實際上,組織經加熱且熱量傳導至電極及電極中之溫度感應器。在一實施例中,若即時溫度上升至預定最大溫度(例如85℃)以上,則系統10可中斷能量傳遞。在此情形下,系統可產生指示高溫條件之訊息。然而,視情況而定,臨床醫師之不同動作可為適當的。
若組織過熱,則可超過建立之溫度臨限值。高組織溫度暗示可能動脈急劇收縮或動脈壁突起。此可在注意到出現高溫且產生訊息後即刻或短時間內(例如約50秒至約100秒)發生。在該情形下,可指令臨床醫師對治療部位成像以在起始另一治療之前注意收縮或突起。
圖6例如為說明根據本發明技術之一實施例用於在偵測到高溫條件時為操作者提供反饋之演算法150的方塊圖。在一實施例中,演算法150係回應於高溫條件(區塊152)而執行且估算(決策區塊154)來自治療之資料以確定該高溫條件涉及包括突發不穩定性之情形還是不涉及此情形。突發不穩定性可例如由患者或導管之突然移動引起,由此引起電極更猛烈地推至(亦即接觸力增加)血管壁中,亦可伴隨有移動至另一位置。在決策區塊154處未偵測到突發不穩定性之情形下,可顯示第一訊息(區塊156),諸如偵測到高溫之指示及對治療部位成像以確定該部位是否受損之指令。在決策區塊154處偵測到突發不穩定性之情形下,可顯示另一訊息(區塊158),除指示出現高溫及指令臨床醫師對治療部位成像以外,亦可指示電極可能自其原始部位移動。該反饋可提示臨床醫師比較先前影像且避免在原始部位或電極移至之部位再次治療。
E.與高阻抗相關之反饋
如同高溫一樣,在某些情況下系統10(圖1)可產生與出現高阻抗有關之訊息。如所瞭解,對自治療電極穿過身體至分散返回電極之RF電流的阻抗可提供關於與治療電極接觸之組織特徵的指示。舉例而言,安置於腎動脈血流中之電極可量測與接觸血管壁之電極相比較低之阻抗。此外,當組織溫度升高時,其阻抗減小。然而,若組織過熱,則其可脫水且其阻抗可增加。在逐漸加熱組織之治療期間,預期阻抗將減小。阻抗顯著升高可為諸如組織脫水或電極移動之不利情形的結果。在某些實施例中,若即時阻抗升高高於自起始阻抗之預定最大阻抗變化,則系統10可經組態以中斷能量傳遞。
圖7例如為說明根據本發明技術之一實施例用於在出現高阻抗條件時為操作者提供反饋之演算法170的方塊圖。在所述實施例中,演算法170估算來自治療之資料且確定偵測高阻抗事件(區塊172)是否可能涉及以下情形:(a)組織溫度高且可能脫水;(b)電極移動;或(c)電極與血管壁接觸不良或未接觸。演算法170估算資料以確定出現該三種情形中之哪一者(若出現)且相應顯示三種訊息174、176或178之一。
根據演算法170之一實施例,在偵測高阻抗(區塊172)時,估算治療期間之最大平均溫度(決策區塊180)。若該溫度在某臨限值以上(例如在60℃或60℃以上),則高阻抗可歸因於導致脫水之高組織溫度。在此情形下,可顯示訊息174,指令臨床醫師檢查收縮或突起(亦即對治療部位成像)且避免在同一位置再次治療。相反,若溫度低於臨限值(例如低於60℃),則演算法170進入決策區塊182。
在所述實施例中,在決策區塊182處,演算法170估算當功率相對較低時,在治療早期(例如在能量傳遞之最初20秒內)是否發生高阻抗事件。若是,則組織溫度不可能高,且更可能為電極初始時接觸不良或無接觸且隨後建立更佳接觸,導致阻抗跳變。在此情形下,可顯示訊息176,指令臨床醫師嘗試建立更佳接觸且在同一部位重複治療。然而,若該事件在治療稍後期(例如過去20秒以上)發生,則演算法170進入決策區塊184。
在決策區塊184處,演算法170估算在治療期間何時發生高阻抗事件。舉例而言,若該事件在預定時間段(例如45秒)之後發生,則當功率達到高位準時,演算法進入決策區塊186。然而,若該事件在功率上升且未處於其最高值時(在20秒與45秒之間)發生,則演算法進入決策區塊188。
在決策區塊186處,演算法170計算在高阻抗事件時與特定時間(例如45秒)之阻抗相比阻抗變化百分比(%ΔZ)。此為功率維持於高位準下之時間段。在一實施例中,阻抗變化百分比如下計算:
若ΔZ%大於或等於預定量(例如7%),則組織可能由於高溫開始脫水。在此情形下,可顯示訊息174,指令臨床醫師檢查收縮或突起(亦即對治療部位成像)且避免在同一位置再次治療。否則,組織脫水不太可能且更可能為電極移動導致高阻抗事件。在此情形下,可顯示訊息178,告知臨床醫師電極可能已移動。在電極已移動或可能已移動之情形下,組織溫度不可能達到高位準。因此,預期若無其他位置或僅有限之其他位置進行另一治療,則可在同一位置進行治療。
在決策區塊188處,演算法170可確定是否出現突發不穩定性。若存在該不穩定性,則電極可能移動。在此情形下,可顯示訊息178,提示臨床醫師電極可能已移動。如上文論述,臨床醫師可小心謹慎且避免原始位置或電極移至之位置,或若無其他部位或僅有限數目之部位可用於進一步治療,則臨床醫師可選擇治療同一位置。否則,若未出現突發不穩定性,則更可能為電極接觸不良。在此情形下,可顯示訊息176,指令臨床醫師嘗試建立更佳接觸且治療同一部位係安全的。
使用替代量測值及計算,可達成偵測高阻抗條件之相同目標。舉例而言,在演算法170之另一實施例中,獲取樣品時間間隔(例如20秒)之溫度及阻抗資料。在較短時間間隔(例如每1.5秒)下,計算阻抗及溫度資料之標準偏差。某一間隔之第一標準溫度計算為溫度之標準偏差除以初始時間間隔下之溫度標準偏差。若阻抗量測值之標準偏差大於或等於預定值(例如10歐姆)且第一標準溫度大於預定臨限值(例如3),則演算法170可顯示訊息176,指示電極接觸不良。然而,若阻抗量測值之標準偏差在可接受範圍以外,但第一標準溫度在可接受範圍以內,則將顯示訊息178以警示臨床醫師存在電極不穩定性。
根據演算法170之另一實施例,兩個或兩個以上電極24(例如安置於圖1之導管12之治療區22上)之阻抗各自可提供獨立之阻抗讀數。在將治療總成22傳遞至治療部位(例如腎動脈內)期間,電極24之阻抗讀數通常由於血管結構解剖學而不同,此係因為導管12將遵照最小電阻之路徑,常在血管結構彎曲處彎曲以僅接觸腎動脈之一個壁。
在某些實施例中,治療總成22一經定位用於治療,治療總成22即可向周圍擴張以接觸腎動脈壁區段之整個周圍表面。此擴張可使多個電極24與腎動脈壁接觸。隨著治療總成22擴張成治療組態且電極24與腎動脈壁之接觸增加,個別電極24之阻抗值可增加及/或接近同一值。在良好穩定接觸下,阻抗值之波動亦如上所述減小。能量產生器26可不斷或連續地監測個別阻抗值。隨後可比較該等值以確定何時建立有效接觸,作為成功治療之指示。在其他實施例中,可將阻抗之變動平均值與阻抗值之預定變化範圍相比較,設定有界限以引導穩定性量測。
F.與血管收縮相關之反饋
在其他實施例中,系統10可產生與發生血管收縮相關之訊息。特定而言,當傳遞治療時,血管可收縮至次最佳直徑。收縮之血管可導致血流量減少、治療部位溫度增加及血壓增加。可藉由對即時溫度資料之幅度(「包絡線」)取樣來量測血管收縮。可將現有包絡線與先前獲取之包絡線樣品(例如200 ms之前)相比較。若現有包絡線與先前時間點包絡線之差值小於預定值(例如小於-0.5℃,或換言之,目前包絡線值與先前時間點之包絡線值相比減小不足0.5度),則在未來時間點獲取量測值(例如在5秒內)。若未來時間點與現有時間點之平均溫度差值大於給定溫度臨限值(例如大於1℃),則演算法800可確定存在不利之高程度收縮,且可中斷/改變能量傳遞。在該情形下,系統10可產生指示高收縮條件之訊息。然而,視情況而定,臨床醫師之不同動作可為適當的。
圖8例如為說明根據本發明技術之一實施例用於在偵測到高度血管收縮時為操作者提供反饋之演算法800的方塊圖。在一實施例中,演算法800係回應於高收縮程度(例如血管收縮在某一直徑或某一直徑以下)(區塊802)而執行且估算(決策區塊804)來自治療之資料以確定高收縮程度涉及包括突發不穩定性之情形還是不涉及此情形。突發不穩定性之指示可指示電極24移動。
在決策區塊804處未偵測到突發不穩定性之情形下,可顯示第一訊息(區塊806),諸如已偵測到高收縮程度之指示及讓臨床醫師減小治療功率之指令。在其他實施例中,能量位準可回應於所偵測之收縮程度自動改變。在決策區塊804處偵測到突發不穩定性之情形下,可顯示另一訊息(區塊808),除指示出現高收縮程度及對臨床醫師之指令以外,亦可指示電極24可能自其原始部位移動。該反饋可提示臨床醫師改變或中斷治療。
G.與心臟因素相關之反饋
1.與異常心跳速率相關之反饋
如同上文提及之其他生理學條件,在某些情形下,系統10可產生與出現異常心跳速率相關之訊息。特定而言,當傳遞治療時,心跳速率可超出或低於有利條件(例如暫時程序性或慢性心動徐緩)。可藉由量測即時溫度及阻抗來確定瞬時心跳速率。更特定而言,可使用第二階Butterworth濾波器濾除例如0.5 Hz與2.5 Hz之間的即時溫度讀數。確定濾除信號之局部最大值。局部最大值為所偵測之即時溫度信號峰值。當信號峰值對應於心臟循環中之週期變化時,瞬時心率為峰值間之間隔。
在一實施例中,若心跳速率在所需範圍以外,則系統10可中斷/改變能量傳遞。在該情形下,系統可產生指示不利心跳速率條件之訊息。然而,視情況而定,臨床醫師之不同動作可為適當的。
圖9例如為說明根據本發明技術之一實施例用於在偵測到異常心跳速率條件時為操作者提供反饋/指令之演算法900的方塊圖。舉例而言,在一實施例中,演算法900可回應於異常心跳速率條件(例如高於或低於預定臨限值)而執行(區塊902)。在決策區塊904處,演算法900估算來自治療之資料以確定所偵測之異常心跳速率條件是否涉及包括突發不穩定性之情形。突發不穩定性之指示可指示電極移動。
在決策區塊904處未偵測到突發不穩定性之情形下,可對臨床醫師顯示第一訊息(區塊906),諸如已偵測到異常心跳速率之指示及讓臨床醫師減小治療功率之指令。在其他實施例中,能量位準可回應於所偵測之不利心跳速率而自動改變。在決策區塊904處偵測到突發不穩定性之情形下,可顯示另一訊息(區塊908),除指示發生異常心跳速率及對臨床醫師之指令以外,亦可指示電極可能自其原始部位移動。該反饋可提示臨床醫師改變或中斷治療。
2.與低血流量相關之反饋
系統10亦可經組態以產生與低血流量條件相關之訊息。舉例而言,若治療期間血流量降至某一位準以下(或若血管不利地狹窄),則對流熱自電極24移除且組織表面減小。過高組織溫度可導致上述消極後果,諸如血栓形成、炭化、不可靠之損害尺寸等。自產生器26減少功率以防止組織達到不可接受之溫度可導致損害深度不足,且神經可能未加熱至足夠之消融溫度。可使用演算法來量測血流量或血流之熱損失。在一實施例中,可用置放於腎動脈中另一導管上或治療導管12上之流量計或都卜勒感應器(Doppler sensor)來量測血流量。在另一實施例中,可藉由傳遞能量(例如RF能量)使血液、組織或基質溫度上升來量測熱損失或熱衰減。能量可切斷且演算法可包括監測作為熱衰減之量度的溫度。快速熱衰減可表示血流量充足,而逐漸熱衰減可表示低血流量。舉例而言,在一實施例中,若即時溫度量測值相對於起始溫度之斜率超過預設臨限值(例如2.75)且平均溫度大於預設溫度(例如65℃),則演算法910可指示低血流量。在其他實施例中,可藉由量測傳遞RF或電阻熱之電極的溫度振盪來表徵熱衰減及/或血流量。在給定溫度或功率傳遞幅度/量值下,狹窄之振盪範圍可指示相對低之熱衰減/血流量。
圖9B例如為說明根據本發明技術之一實施例在出現低血流量條件時為操作者提供反饋/指令之演算法910的方塊圖。在一實施例中,演算法910回應於所偵測之低血流量條件(例如流量低於預定臨限值)而執行(區塊912)。在區塊914處,演算法910估算來自治療之資料以確定低血流量條件是否涉及包括突發不穩定性之情形。在決策區塊914處未偵測到突發不穩定性之情形下,可顯示第一訊息(區塊916),諸如已偵測到低血流量之指示及讓臨床醫師減小治療功率之指令。在偵測到突發不穩定性之情形下,可顯示另一訊息(區塊918),除指示發生低血流量及對臨床醫師之指令以外,亦可指示電極可能自其原始部位移動。如上所述,該反饋可促使臨床醫師改變或中斷治療。
在其他實施例中,若血流量或熱衰減值低於典型或預定臨限值,則能量傳遞演算法910可包括自動改變治療或導管之一或多個條件或特徵以改良血流量。舉例而言,在一實施例中,演算法910可藉由提供至能量傳遞元件24之能量呈脈衝形式提供而非提供連續能量來回應於低血流量。此可使得較低血流量可更充足地自組織表面移除熱量,同時仍產生足夠深之損害以消融神經。
在另一實施例中,演算法910可包括藉由冷卻電極來回應於低血流量,如2011年4月26日申請之國際專利申請案第PCT/US2011/033491號及2010年8月30日申請之美國專利申請案第12/874,457號中進一步詳述。以上申請案以全文引用的方式併入本文中。
在另一實施例中,演算法910可藉由需要向該區域手動增加血流量來回應於低血流量。舉例而言,非阻塞性氣球可在腹主動脈中膨脹,藉此增加腎動脈中之壓力及流量。該氣球可併入治療導管或另一導管上。
H.反饋顯示
圖10A及10B為說明根據本發明技術之態樣組態之代表性產生器顯示螢幕的螢幕擷取畫面。圖10A例如為治療期間追蹤增強阻抗之顯示螢幕1100。顯示器1100包括在選定時間段(例如100秒)內即時追蹤阻抗量測值之圖形顯示1110。該圖形顯示1110例如可為以週期性間隔更新之動態、滾動顯示,為操作者提供阻抗量測值之瞬時及歷史追蹤。顯示1110亦可包括具有目前阻抗之阻抗顯示1120以及關於阻抗之標準偏差指示1122。在一實施例中,標準偏差指示1122經組態為當該值大於10時閃爍。此類指示可警示造影劑注射之操作者造影劑注射影響量測或電極可能不穩定。下文描述關於造影劑注射指示之其他資訊。
圖10B例如為具有用於操作者之額外資訊的另一代表性顯示螢幕1130。在該實例中,顯示螢幕1130經組態以警示造影劑注射之操作者且系統在開始之前正等待造影至清晰(例如停用RF約1至2秒,直至造影清晰)。在另一實施例中,顯示螢幕1130可經組態以提供其他警示訊息(例如「可能不穩定電極」等)。預期上述顯示螢幕1110及1130中提供之額外資訊可在RF開啟之前改良接觸評估,且改良治療效率及功效。
上文參考圖10A及10B描述之額外資訊可基於本文所述之演算法或其他適合演算法產生。舉例而言,在一實施例中,演算法可不斷檢查RF開啟之前時期的造影劑注射/穩定性。若電極穩定且歷時1秒無造影,則將基線阻抗Z設定為等於1秒內之平均阻抗Z。在一特定實例中,將即時阻抗與一秒窗口內之平均阻抗值的兩個標準偏差相比較。在另一特定實例中,可將即時阻抗與固定值相比較(例如確定標準偏差是否大於10)。在其他實例中,可使用其他配置。
若即時阻抗量測值在此範圍內,則不顯示訊息。然而,若即時阻抗不在平均值之兩個標準偏差內,則電極可能為不穩定的(亦即漂移、移動等)且可對使用者顯示上文參考圖10A及10B描述之一或兩種訊息(例如「等待造影至清晰」、「可能不穩定電極」)。舉例而言,對於造影劑注射偵測而言,除阻抗之標準偏差以外,演算法可經組態為將即時溫度量測值之標準偏差化為因子以尋求即時溫度偏移至起始體溫以下。溫度偏移截止點之精確值可變化。在一特定實例中,系統可經組態以使得若伴隨即時溫度下降,阻抗增加(例如標準偏差>10),則系統將標示造影偵測事件,導致對操作者顯示「等待造影至清晰」訊息。然而在其他實例中,可使用其他演算法及/或範圍來確定造影劑注射事件及/或電極之穩定性。另外,在其他實施例中,系統可基於所偵測之條件修改/調整各種治療參數,而不對臨床醫師顯示該等訊息。
IV.相關解剖學及生理學
以下論述提供關於相關患者解剖學及生理學之其他詳情。此部分欲補充及擴展先前關於相關解剖學及生理學之論述,且提供關於與腎去神經支配相關之揭示技術及治療益處的額外內容。舉例而言,如前文所提及,腎血管結構之若干特性可告知用於經由血管內通道達成腎神經調節之治療裝置及相關方法的設計,且對該等裝置強加特定設計要求。特定設計要求可包括評估腎動脈、促使該等裝置之能量傳遞元件與腎動脈之管腔表面或壁之間穩定接觸及/或用神經調節裝置有效調節腎神經。
A.交感神經系統
交感神經系統(SNS)為除腸神經系統及副交感神經系統以外自主神經系統之分支。其在基礎水準下始終具有活性(稱作交感神經張力),且在壓力時間期間更具活性。如同神經系統之其他部分,交感神經系統經由一系列相互連接之神經元運作。交感神經元常被認為係周邊神經系統(PNS)之一部分,儘管有許多在中樞神經系統(CNS)內。脊髓(其為CNS之一部分)之交感神經元經由一系列交感神經節與周邊交感神經元通信。在神經節內,脊髓交感神經元經由突觸接合周邊交感神經元。因此,脊髓交感神經元稱作突觸前(或節前)神經元,而周邊交感神經元稱作突觸後(或節後)神經元。
在交感神經節內之突觸處,節前交感神經元釋放乙醯膽鹼,其為一種結合且活化節後神經元上之菸鹼型乙醯膽鹼受體的化學信使。回應於此刺激,節後神經元主要釋放去甲腎上腺素(正腎上腺素)。長時期活化可引發自腎上腺髓質釋放腎上腺素。
一經釋放,去甲腎上腺素及腎上腺素即結合周邊組織上之腎上腺素激導性受體。結合於腎上腺素激導性受體會引起神經元及激素反應。生理學表現包括瞳孔放大、心跳速率增加、偶發性嘔吐及血壓增加。由於結合汗腺之膽鹼激導性受體,故亦可見發汗增加。
交感神經系統負責上調及下調活生物體內之多種自動調節機制。來自SNS之纖維神經支配幾乎每一器官系統中之組織,對諸如瞳孔直徑、腸動力及尿排出量之多種事物提供至少一些調節功能。此反應亦稱作身體之交感-腎上腺反應,因為在腎上腺髓質中終止之節前交感神經纖維(以及所有其他交感神經纖維)均分泌乙醯膽鹼,其活化腎上腺素之分泌,且在較小程度上活化去甲腎上腺素(正腎上腺素)之分泌。因此,主要作用於心血管系統之此反應經由經交感神經系統傳輸之脈衝直接介導,且經由自腎上腺髓質分泌之兒茶酚胺間接介導。
科學一般將SNS看作自主調節系統,亦即不受意識思維干預而運作之系統。一些進化理論家提出,交感神經系統在早期生物體中為維持存活而運作,因為交感神經系統負責激活身體行動。此激活作用之一實例為睡醒前之時刻,此時交感神經流出物自發增加以準備行動。
1.交感神經鏈
如圖11中所示,SNS提供可使大腦與身體通信之神經網路。交感神經源自脊柱內,朝向中間外側細胞柱(或側角)中脊髓中部,起始於脊髓之第一胸段且認為其延伸至第二或第三腰段。由於其細胞起始於脊髓之胸區及腰區,因此稱SNS具有胸腰部流出物。該等神經之軸突經由前部支根/根離開脊髓。其穿過脊柱(感應)神經節附近,由此處進入脊柱神經之前支。然而,與軀體神經支配不同,其經由連接至沿脊柱延伸之椎骨旁(其位於脊柱附近)或椎骨前(其位於主動脈分叉附近)神經節之白色分支連接體快速分出。
為到達目標器官及腺體,軸突將在體內穿行較長距離,且為達成此目的,許多軸突經由突觸傳輸將其訊息轉至第二細胞。軸突末端穿過一定空間將突觸連接至第二細胞之樹突。第一細胞(突觸前細胞)穿過突觸間隙傳送神經傳遞質,神經傳遞質在此處活化第二細胞(突觸後細胞)。隨後將訊息載運至最終目的地。
在周邊神經系統之SNS及其他組分中,在稱作神經節之位點處產生該等突觸。傳送其纖維之細胞稱作節前細胞,而纖維離開神經節之細胞稱作節後細胞。如前文所提及,SNS之節前細胞位於脊髓之第一胸(T1)段與第三腰(L3)段之間。節後細胞在神經節中具有其細胞體且將其軸突傳送至目標器官或腺體。
神經節不僅包括交感神經幹,而且亦包括頸部神經節(上部、中部及下部)(其將交感神經纖維傳送至頭部及胸部器官)及腹腔與腸系膜神經節(其將交感神經纖維傳送至腸)。
2.腎臟之神經支配
如圖12所示,腎臟由與腎動脈密切相關之腎叢RP神經支配。腎叢RP為包圍腎動脈且嵌埋於腎動脈外膜內之自主神經叢。腎叢RP沿腎動脈延伸,直至其到達腎臟本體。促成腎叢RP之纖維起於腹腔神經節、腸系膜上神經節、主動脈腎神經節及主動脈叢。腎叢RP(亦稱作腎神經)主要包含交感神經組分。不存在(或至少極小)腎臟之副交感神經神經支配作用。
節前神經元細胞體位於脊髓之中間外側細胞柱中。節前軸突穿過椎骨旁神經節(其不形成突觸)以成為較小內臟神經、最小內臟神經、第一腰部內臟神經、第二腰部內臟神經且行進至腹腔神經節、腸系膜上神經節及主動脈腎神經節。節後神經元細胞體離開腹腔神經節、上部腸系膜神經節及主動脈腎神經節至腎叢RP且分佈至腎血管結構。
3.腎交感神經神經活性
訊息以雙向流之形式穿過SNS。傳出訊息可同時觸發身體不同部分之變化。舉例而言,交感神經系統可加速心跳速率;加寬支氣管通道;減少大腸動力(運動);收縮血管;增加食道蠕動;導致瞳孔放大、豎毛(雞皮疙瘩)及出汗(發汗);及升高血壓。傳入訊息將來自體內各種器官及感覺受體之信號載運至其他器官,且尤其載運至大腦。
高血壓、心臟衰竭及慢性腎臟疾病為由SNS(尤其為腎交感神經系統)之慢性活化引起之多種疾病病況中的一些。SNS之慢性活化為驅使該等疾病病況發展的不適反應。腎素-血管收縮素-醛固酮系統(RAAS)之醫藥管理已長期存在,但某種程度上為降低SNS過度活性無效之方法。
如上文所提及,已在實驗上與人類中確認腎交感神經系統為高血壓、容量負荷過重狀態(諸如心臟衰竭)及進行性腎病之複雜病理生理學的主要原因。採用放射性示蹤劑稀釋方法以量測自腎臟至血漿之去甲腎上腺素溢出的研究表明原發性高血壓患者體內腎去甲腎上腺素(NE)溢出率增加,在年輕高血壓個體中尤為如此,與自心臟之NE溢出率增加相呼應,其與通常在早期高血壓中所見之血液動力學概況相一致且其特徵在於心跳速率、心臟輸出及腎血管抗性增加。現已知,原發性高血壓通常為神經性的,常伴有顯著之交感神經系統過度活性。
如由該患者群中自心臟及腎臟至血漿之NE溢出的過度增加所表明,心腎交感神經活性之活化在心臟衰竭中甚至更為顯著。與此觀點一致的是,近期在充血性心臟衰竭患者中證明腎交感神經活化對所有成因死亡及心臟移植之強負性預測值,其與總體交感神經活性、腎小球濾過率及左心室射血分數無關。該等發現支持以下觀點,即經設計用以減少腎交感神經刺激之治療方案具有提高心臟衰竭患者存活率之潛能。
慢性與晚期腎病之特徵在於交感神經活化增強。在晚期腎病患者中,已證明高於中值之去甲腎上腺素血漿含量預測所有成因之死亡及由心血管疾病引起之死亡。對於患有糖尿病或造影劑腎病變之患者而言亦為如此。有令人信服之證據表明,源自患病腎臟之感覺傳入信號為在該患者群中起始及維持高中樞交感神經流出量之主要因素;此促使慢性交感神經過度活性之熟知不利後果發生,諸如高血壓、左心室肥大、心室調律不整、心源性猝死、胰島素抗性、糖尿病及代謝症候群。
(i)腎交感神經傳出活性
腎臟之交感神經終止於血管、近腎小球器及腎小管中。刺激腎交感神經可導致腎素釋放增加、鈉(Na+
)再吸收增加及腎血流量減少。腎功能之該等神經調節組分在特徵為交感神經張力升高之疾病病況中大大受刺激,且可能導致高血壓患者之血壓增加。腎血流量及腎小球濾過率由於腎交感神經傳出刺激而減少可能成為心-腎症候群中腎功能喪失(亦即作為慢性心臟衰竭之進行性併發症的腎功能障礙,伴有通常隨患者臨床狀態及治療而波動之臨床過程)之基礎。阻止腎傳出交感神經刺激後果之藥理學策略包括作用於中樞神經之抑交感神經作用藥物、β阻斷劑(欲減少腎素釋放)、血管收縮素轉化酶抑制劑及受體阻斷劑(欲阻斷由腎素釋放所引起之血管收縮素II作用及醛固酮活化)以及利尿劑(欲對抗腎交感神經介導之鈉及水滯留)。然而,該等藥理學策略具有顯著侷限性,包括功效有限、適應性問題、副作用及其他限制。
(ii)腎感覺傳入神經活性
腎臟經由腎感覺傳入神經與中樞神經系統中之完整結構通信。若干形式之「腎損傷」可誘發感覺傳入信號之活化。舉例而言,腎缺血、心搏出量或腎血流量減少或腺苷酶充裕可觸發傳入神經通信之活化。如圖13A及13B中所示,該傳入通信可自腎臟至大腦或可自一個腎臟至另一腎臟(經由中樞神經系統)。該等傳入信號經中樞神經整合且可導致交感神經流出量增加。該交感神經傳動指向腎臟,藉此活化RAAS且誘發腎素分泌、鈉滯留、體積滯留及血管收縮增加。中樞交感神經過度活性亦影響由交感神經神經支配之其他器官及身體結構,諸如心臟及周邊血管結構,導致所述對交感神經活化之不利作用,其若干態樣亦歸因於血壓升高。
因此,生理學表明:(i)以傳出交感神經調節組織將減少不當之腎素釋放、鹽滯留且減少腎血流量;及(ii)以傳入感覺神經調節組織將經由其對後部下丘腦以及對側腎臟之直接作用而減少對高血壓及其他與中樞交感神經張力增加相關聯之疾病病況的全身性貢獻。除傳入腎去神經支配之中樞血壓過低作用以外,預期將有利減少各種其他交感神經神經支配器官(諸如心臟及血管結構)的中樞交感神經流出量。
B.腎去神經支配之其他臨床益處
如上文所提供,腎去神經支配可用於治療特徵為總體且尤其腎交感神經活性增加之若干臨床病狀,該等病狀諸如高血壓、代謝症候群、胰島素抗性、糖尿病、左心室肥大、慢性晚期腎病、心臟衰竭中之不當體液滯留、心-腎症候群及猝死。由於傳入神經信號之減少會導致交感神經張力/傳動全身性減少,因此,腎去神經支配亦可用於治療其他與全身性交感神經亢進相關聯之病狀。因此,腎去神經支配亦可有益於交感神經神經支配之其他器官及身體結構,包括圖11中鑑別者。舉例而言,如前文所論述,中樞交感神經傳動減少可降低折磨罹患代謝症候群及II型糖尿病之人的胰島素抗性。因此,骨質疏鬆症患者亦經由交感神經活化且亦可受益於伴隨腎去神經支配之交感神經傳動下調。
C.達成通向腎動脈之血管內通道
根據本發明之技術,與左及/或右腎動脈密切相關之左及/或右腎叢RP的神經調節可經由血管內通道達成。如圖14A所示,藉由心臟收縮而移動之血液由主動脈自心臟之左心室輸送。主動脈穿過胸腔及分支向下延伸至左及右腎動脈中。在腎動脈以下,主動脈在左及右髂骨動脈處分叉。左及右髂骨動脈分別向下延伸穿過左及右腿且接合左及右股動脈。
如圖14B所示,血液彙集於靜脈中且返回心臟,經由股靜脈返回髂骨靜脈及下腔靜脈中。下腔靜脈分叉成左及右腎靜脈。在腎靜脈上方,下腔靜脈向上延伸以將血液輸送至心臟之右心房中。自右心房,血液經由右心室泵至肺中,在肺中氧化。自肺,經氧化之血液輸送至左心房中。自左心房,經氧化之血液藉由左心室輸送回主動脈。
如下文將更詳細描述,可在剛好位於腹股溝韌帶中點下部之股三角區基點進入股動脈且插入導管。可經由該進入部位將導管經皮插入股動脈、穿過髂骨動脈及主動脈且置放於左或右腎動脈中。此包含為各別腎動脈及/或其他腎血管提供最小侵襲性通道之血管內路徑。
手腕、上臂及肩部區域提供其他用於向動脈系統中引入導管之位置。舉例而言,在選擇情形下可使用橈動脈、肱動脈或腋動脈之導管插入。使用標準血管造影技術使經由該等進入點引入之導管可穿過位於左側之鎖骨下動脈(或經由位於右側之鎖骨下動脈及頭臂動脈)、穿過主動脈弧、向下穿過降主動脈且進入腎動脈。
D.腎血管結構之特性及特徵
由於左及/或右腎叢RP之神經調節可根據本發明之技術經由血管內通道來達成,因此腎血管結構之特性及特徵可對達成該腎神經調節之設備、系統及方法的設計施加限制及/或予以告知。某些該等特性及特徵可在患者群體之間變化及/或在特定患者中隨時間而變化,以及回應於諸如以下之疾病病況而變化:高血壓、慢性腎臟疾病、血管疾病、晚期腎病、胰島素抗性、糖尿病、代謝症候群等。如本文解釋之該等特性及特徵對程序功效及血管內裝置之特定設計有影響。舉例而言,相關特性可包括材料/機械、空間、流體動力學/血液動力學及/或熱動力學特性。
如前文所論述,導管可經由最小侵襲性血管內路徑經皮行進至左或右腎動脈中。然而,最小侵襲性腎動脈通道可具挑戰性,例如因為與常規使用導管進入之某些其他動脈相比,腎動脈常極其扭曲、可具有相對小之直徑及/或可具有相對短之長度。此外,腎動脈粥樣硬化在許多患者中為常見的,尤其為患有心血管疾病之患者。腎動脈解剖學亦可在患者之間顯著變化,此進一步使得最小侵襲性通道變得複雜。舉例而言,在相對扭曲度、直徑、長度及/或動脈粥樣硬化斑負荷以及腎動脈自主動脈分叉之分開角方面可見顯著的患者間變化。用於經由血管內通道達成腎神經調節之設備、系統及方法應說明腎動脈解剖學及其在最小侵襲性進入腎動脈時患者群體之間的變化之該等及其他態樣。
除使得腎動脈通道變得複雜以外,腎解剖學之細節亦使得在神經調節設備與腎動脈之管腔表面或壁之間建立穩定接觸變得複雜。當神經調節設備包括能量傳遞元件(諸如電極)時,一致定位及由能量傳遞元件施加至血管壁之適當接觸力對於可預測性而言係重要的。然而,腎動脈內之緊密空間以及動脈之扭曲會使導航受阻。此外,建立一致接觸因患者移動、呼吸及/或心臟循環而變得複雜,此係因為該等因素可引起腎動脈相對於主動脈顯著移動,且心臟循環可瞬時擴張腎動脈(亦即引起動脈壁脈動)。
即使在進入腎動脈且促成神經調節設備與動脈管腔表面之間的穩定接觸之後,動脈外膜中及其周圍之神經仍應經由神經調節設備安全地調節。考慮到潛在之臨床併發症與腎動脈內熱治療相關聯,所以有效施用該治療並非微不足道。舉例而言,腎動脈之內膜及中膜極易被熱損傷損壞。如下文更詳細論述,將血管內腔與其外膜分隔之內膜-中膜厚度意謂目標腎神經可距動脈管腔表面數毫米遠。足夠能量應傳遞至目標腎神經或自其移除足夠熱量來調節目標腎神經,而不將血管壁過度冷卻或加熱至壁冷凍、脫水或潛在不利地影響之程度。與過度加熱相關聯之潛在臨床併發症為自流經動脈之血液凝聚而形成之血栓。假定該血栓可導致腎臟梗塞,藉此對腎臟造成不可逆轉之損害,則應小心施加腎動脈內之熱治療。因此,治療期間在腎動脈中存在之複雜流體機械學及熱力學條件,尤其在治療部位可影響熱傳遞動力學之彼等條件,對於對腎動脈中之組織施加能量(例如加熱熱能)及/或自其移除熱量(例如冷卻熱條件)而言可為重要的。
神經調節設備亦應經組態以使得能量傳遞元件可在腎動脈內可調節地定位及再定位,因為治療位置亦可影響臨床功效。舉例而言,考慮到腎神經可在腎動脈周圍沿圓周間隔,在腎動脈內施加完整圓周治療可具吸引力。在某些情形下,可能由連續圓周治療引起之全圓損害可能與腎動脈狹窄相關。因此,宜經由本文所述之篩網結構沿腎動脈之縱向方向形成更複雜之損害及/或將神經調節設備再定位至多個治療位置。然而應注意,產生圓周消融之益處可超出腎動脈狹窄之可能性,或在某些實施例中或在某些患者中該風險可減小,且產生圓周消融可為目標。另外,可證明神經調節設備之可變定位及再定位適用於腎動脈尤其扭曲或鄰近分支血遠離腎動脈主血管,使得在某些位置之治療具有挑戰性的情形。在腎動脈中操縱裝置亦應考慮裝置對腎動脈造成之機械損傷。例如藉由插入、操縱、轉向彎曲等裝置在動脈中之活動可導致剖開、穿孔、內膜裸露或使內彈性層破裂。
流經腎動脈之血流可短時間暫時閉塞,具有極小或無併發症。然而,應避免顯著時間量閉塞,因為需預防對腎臟之損傷(諸如缺血)。宜完全避免閉塞,或若閉塞有益於該實施例,則宜將閉塞之持續時間限制為例如2至5分鐘。
基於(1)腎動脈介入術、(2)相對於血管壁一致且穩定置放治療元件、(3)沿血管壁有效施加治療、(4)定位及可能再定位治療設備以慮及多個治療位置及(5)避免血流閉塞或限制其持續時間之上述挑戰,可關注之腎血管結構的獨立及相關特性包括例如(a)血管直徑、血管長度、內膜-中膜厚度、摩擦係數及扭曲度;(b)血管壁之膨脹性、硬度及彈性模數;(c)峰值收縮、舒張末期血流速度以及平均收縮-舒張峰值血流速度及平均/最大體積血流速率;(d)血液及/或血管壁之比熱容量、血液及/或血管壁之熱導率、及/或穿過血管壁治療部位之血流熱對流及/或輻射熱傳遞;(e)由呼吸、患者移動及/或血流脈動誘發之腎動脈相對於主動脈之運動;及(f)以及腎動脈相對於主動脈之分開角。將更詳細論述腎動脈之該等特性。然而,視用於達成腎神經調節之設備、系統及方法而定,腎動脈之該等特性亦可引導及/或限制設計特徵。
如上文所示,定位於腎動脈內之裝置應符合動脈之幾何結構。腎動脈血管直徑DRA
通常在約2至10 mm之範圍內,大部分患者群體具有約4 mm至約8 mm且平均約6 mm之DRA
。主動脈/腎動脈接合點處之腎動脈小孔與其遠端分支之間的腎動脈血管長度LRA
一般在約5至70 mm之範圍內,且顯著部分之患者群體在約20至50 mm之範圍內。由於目標腎叢嵌埋於腎動脈之外膜內,因此複合內膜-中膜厚度IMT(亦即自動脈管腔表面至含有目標神經結構之外膜的徑向朝外距離)亦值得注意且一般在約0.5至2.5 mm之範圍內,其平均值約為1.5 mm。儘管一定治療深度對於到達目標神經纖維係重要的,但治療不應過深(例如自腎動脈內壁>5 mm)以避免非目標組織及解剖結構(諸如腎靜脈)。
可關注之腎動脈的另一特性為由呼吸及/或血流脈動誘發之腎相對於主動脈之運動度數。位於腎動脈遠端之患者腎臟在呼吸移動下可向顱側移動多達4"。此可使連接主動脈與腎臟之腎動脈顯著運動,藉此要求神經調節設備達成硬度與可撓性之間的獨特平衡以在呼吸循環期間維持熱治療元件與血管壁之間的接觸。此外,腎動脈與主動脈之間的分開角可在患者之間顯著變化,且亦可在同一患者中例如由於腎臟運動而動態變化。分開角通常可在約30°至135°之範圍內。
V.結論
本技術實施例之以上詳細描述不欲為詳盡的,或不欲將本技術限於上文揭示之確切形式。儘管上文為達成說明目的而描述本技術之特定實施例及實例,但如熟習相關技術者所瞭解,各種相等修改在本技術範疇內為可能的。舉例而言,儘管步驟以給定次序呈現,但替代實施例可以不同次序執行各步驟。本文所述之各種實施例亦可組合以提供其他實施例。
由上文將瞭解,本文為達成說明目的而描述本技術之特定實施例,但熟知結構及功能尚未詳細顯示或描述以避免不必要地模糊本技術實施例之描述。若上下文允許,則單數或複數術語亦可各別包括複數或單數術語。舉例而言,如前文所示,儘管本文之諸多揭示內容以單數形式描述能量傳遞元件24(例如電極),但應瞭解,本發明不排除兩個或兩個以上能量傳遞元件或電極。
此外,在提及兩個或兩個以上項目之清單時,除非明
確限制詞彙「或」僅意謂排除其他項目之單一項目,否則在該清單中使用「或」應解釋為包括(a)該清單中之任何單一項目、(b)該清單中之所有項目或(c)該清單中項目之任意組合。另外,全文使用之術語「包含」意謂至少包括所述特徵,以使得不排除任何更多數目之相同特徵及/或其他類型之其他特徵。亦應瞭解,本文為達成說明目的而描述特定實施例,但在不偏離本技術之情況下可進行各種修改。此外,儘管與本技術某些實施例相關之優勢已在彼等實施例之內容中加以描述,但其他實施例亦可展示該等優勢,且並非所有實施例均需要一定展示該等優勢以在本技術之範疇內。因此,本發明及相關技術可包含本文中未明確顯示或描述之其他實施例。
本發明可由一或多個以下條款來定義:1.一種用於腎神經調節之系統,該系統包含:一導管,其包含一具有一近端部分及一遠端部分之細長軸,其中該遠端部分包含一經組態以置放於腎血管中之能量傳遞元件;一能源,其耦接至該能量傳遞元件且經組態以經由該能量傳遞元件將能量傳遞至接近該腎血管之壁之目標神經纖維,其中該能源包含一組件,其經組態以(a)在第一時間段內使能量傳遞增加至預定第一功率位準;(b)將能量傳遞維持在該第一功率位準歷時第二時間
段;及(c)若在該第二時間段之後溫度值小於預設臨限值溫度,則將能量傳遞增加至第二預定功率位準;且其中該能源進一步包含一組件,其經組態以(d)獲得一組對應於使用該導管、該能源及該能量傳遞元件進行之完全治療的治療資料;(e)根據一或多個標準估算該組治療資料以確定該完全治療之估值是否可能在預定範圍內;及(f)提供關於該完全治療之該估值是否可能在該預定範圍內之指示。
2.如條款1之系統,其中該組治療資料為對應於第一完全治療之第一組治療資料,且其中該系統經進一步組態以(a)至少部分地基於對該第一治療資料之該估算及關於該第一完全治療之該估值是否在該預定範圍內之該指示修改該第一預定功率位準、該第一時間段、該第二時間段及/或該第二預定功率位準;(b)使用該經修改之第一預定功率位準、經修改之第一時間段、經修改之第二時間段及/或經修改之第二預定功率位準進行第二治療;及(c)獲得對應於第二完全治療之第二組治療資料。
3.如條款1之系統,其中該組治療資料包含關於基於溫度之量測值、基於阻抗之量測值、基於血流量之量測值或基於移動之測定值中之一或多者的資料。
4.如條款1之系統,其中該組治療資料包含一或多個關
於以下之量測值:指定時間內之溫度變化、最大溫度、最大平均溫度、最小溫度、在預定或計算時間相對於預定或計算溫度之溫度、指定時間內之平均溫度、最大血流量、最小血流量、在預定或計算時間相對於預定或計算血流量之血流量、隨時間變化之平均血流量、最大阻抗、最小阻抗、在預定或計算時間相對於預定或計算阻抗之阻抗、指定時間內之阻抗變化或指定時間內相對於溫度變化之阻抗變化。
5.如條款1之系統,其中:該能量傳遞元件包含一第一能量傳遞元件,且其中該導管進一步包含一耦接至該能源且經組態以將能量傳遞至該目標神經纖維的第二能量傳遞;且該組治療資料包含關於該第一能量傳遞元件之基於阻抗之量測值的第一組資料及關於該第二能量傳遞元件之基於阻抗之量測值的第二組資料。
6.如條款5之系統,其中根據一或多個標準估算該組治療資料包含將該第一組資料與該第二組資料相比較。
7.如條款1之系統,其中估算該組治療資料包含產生一用以確定該完全治療是否成功之分值。
8.如條款1之系統,其中估算該組治療資料包含執行線性判別分析。
9.如條款8之系統,其中該線性判別分析產生一用以確定該完全治療是否成功之分值。
10.如條款1之系統,其進一步包含一顯示螢幕,且其
中該提供之指示包含在該顯示螢幕上顯示之訊息。
11.如條款10之系統,其進一步包含一用於量測治療部位或電極之阻抗的阻抗感應器,且其中該能源經進一步組態以在選定時間段內追蹤即時阻抗量測值且在該顯示螢幕上顯示該即時阻抗量測值。
12.一種電腦可讀儲存媒體,其含有在由一電腦執行時執行包含以下之操作的指令:增加由一導管載運之一能量傳遞元件的能量傳遞,其中在第一時間段內使能量傳遞增加至預定第一功率位準,且其中該能量傳遞元件經定位以將能量傳遞至接近人類患者之腎血管之壁的目標神經纖維;將能量傳遞維持在該第一功率位準歷時第二時間段;若在該第二時間段之後溫度值小於預設臨限值溫度,則將能量傳遞增加至第二預定功率位準;獲得一組對應於使用該能量傳遞元件進行之完全治療的治療資料;根據一或多個標準估算該組治療資料以確定該完全治療之估值是否可能在預定範圍內;及提供關於該完全治療之該估值是否在該預定範圍內之指示。
13.如條款12之電腦可讀儲存媒體,其中該組治療資料包含關於基於溫度之量測值、基於阻抗之量測值、基於血流量之量測值或基於移動之測定值中之一或多者的資料。
14.如條款12之電腦可讀儲存媒體,其中操作參數包含
溫度、時間、阻抗、功率、血流量、流動速度、體積流動速率、血壓或心跳速率中之一或多者。
15.如條款12之電腦可讀儲存媒體,其中該組治療資料包含一或多個關於以下之量測值:指定時間內之溫度變化、最大溫度、最大平均溫度、最小溫度、在預定或計算時間相對於預定或計算溫度之溫度、指定時間內之平均溫度、最大血流量、最小血流量、在預定或計算時間相對於預定或計算血流量之血流量、隨時間變化之平均血流量、最大阻抗、最小阻抗、在預定或計算時間相對於預定或計算阻抗之阻抗、指定時間內之阻抗變化或指定時間內相對於溫度變化之阻抗變化。
16.如條款12之電腦可讀儲存媒體,其中該組治療資料包含對應於第一完全治療之第一組治療資料,且其中該等操作進一步包含:至少部分地基於對該第一治療資料之估算及關於該第一完全治療之該估值是否在該預定範圍內之該指示修改該第一預定功率位準、該第一時間段、該第二時間段及/或該第二預定功率位準;使用該經修改之第一預定功率位準、經修改之第一時間段、經修改之第二時間段及/或經修改之第二預定功率位準進行第二治療;及獲得對應於第二完全治療之第二組治療資料。
17.如條款12之電腦可讀儲存媒體,其中估算該組治療資料包含產生一用以確定該完全治療是否在該預定範圍內
或該完全治療是否未如預期進行之分值。
18.如條款12之電腦可讀儲存媒體,其中估算該組治療資料包含執行線性判別分析。
19.如條款17之電腦可讀儲存媒體,其中該線性判別分析產生一用以確定該完全治療是否在該預定範圍內之分值。
20.如條款12之電腦可讀儲存媒體,其中該提供之指示包含顯示在用於投與該完全治療之一系統之一顯示螢幕上的訊息。
21.如條款20之電腦可讀儲存媒體,其中提供關於該完全治療是否在該預定範圍內之指示包含:若該治療之該估值在該預定範圍內,則在該顯示螢幕上顯示第一訊息;及若該治療之該估值指示治療未如預期進行,則在該顯示螢幕上顯示第二不同訊息。
22.如條款12之電腦可讀儲存媒體,其中若操作參數超出預定範圍,則將能量傳遞增加至預定第二功率位準包含若第一能量傳遞元件與第二能量傳遞元件之阻抗值差異超出預定範圍,則將能量傳遞增加至預定第二功率位準。
10‧‧‧腎神經調節系統
12‧‧‧治療裝置
16‧‧‧細長軸
18‧‧‧近端部分
20‧‧‧遠端部分
22‧‧‧治療總成/治療區
24‧‧‧能量傳遞元件
26‧‧‧能量產生器
28‧‧‧電纜
30‧‧‧自動控制演算法
31‧‧‧估算/反饋演算法
32‧‧‧腳踏板
33‧‧‧顯示器
34‧‧‧手柄總成
38‧‧‧中性或分散電極
80‧‧‧治療演算法
100‧‧‧治療估算演算法
112‧‧‧線性判別分析(LDA)
114‧‧‧係數
150‧‧‧演算法
170‧‧‧演算法
800‧‧‧演算法
900‧‧‧演算法
910‧‧‧演算法
1100‧‧‧顯示器
1110‧‧‧圖形顯示
1120‧‧‧阻抗顯示
1122‧‧‧標準偏差指示
1130‧‧‧顯示螢幕
參考以下圖式可更佳地理解本發明之諸多態樣。圖式中之組分不必按比例。實際上,重在明確說明本發明之原則。
圖1說明根據本發明技術之一實施例組態之腎神經調
節系統。
圖2說明用根據本技術之一實施例之導管設備調節腎神經。
圖3為描繪根據本技術之一實施例可結合圖1系統使用之能量傳遞演算法的圖。
圖4及5為說明根據本發明技術之實施例用於估算治療之演算法的方塊圖。
圖6為說明根據本發明技術之一實施例用於在出現高溫條件時為操作者提供反饋之演算法的方塊圖。
圖7為說明根據本發明技術之一實施例用於在出現高阻抗條件時為操作者提供反饋之演算法的方塊圖。
圖8為說明根據本發明技術之一實施例用於在出現高度血管收縮時為操作者提供反饋之演算法的方塊圖。
圖9A為說明根據本發明技術之一實施例用於在出現異常心跳速率條件時為操作者提供反饋之演算法的方塊圖。
圖9B為說明根據本發明技術之一實施例用於在出現低血流量條件時為操作者提供反饋之演算法的方塊圖。
圖10A及10B為說明根據本發明技術之態樣組態之代表性產生器顯示螢幕的螢幕擷取畫面。
圖11為對交感神經系統(SNS)以及大腦如何經由SNS與身體通信之概念性說明。
圖12為神經支配左腎以在左腎動脈周圍形成腎叢之神經的放大解剖圖。
圖13A及13B提供分別描繪大腦與腎臟之間的神經傳
出與傳入通信的人體解剖圖及概念圖。
圖14A及14B分別為人類動脈及靜脈血管結構之解剖圖。
10‧‧‧腎神經調節系統
12‧‧‧治療裝置
16‧‧‧細長軸
18‧‧‧近端部分
20‧‧‧遠端部分
22‧‧‧治療總成/治療區
24‧‧‧能量傳遞元件
26‧‧‧能量產生器
28‧‧‧電纜
30‧‧‧自動控制演算法
31‧‧‧估算/反饋演算法
32‧‧‧腳踏板
33‧‧‧顯示器
34‧‧‧手柄總成
38‧‧‧中性或分散電極
Claims (11)
- 一種用於腎神經調節之系統,該系統包含:一導管,其包含一具有一近端部分及一遠端部分之細長軸,其中該遠端部分包含一經組態以置放於腎血管中之能量傳遞元件;一能源,其耦接至該能量傳遞元件且經組態以經由該能量傳遞元件將能量傳遞至接近該腎血管之壁之目標神經纖維,其中該能源包含一組件,其經組態以(a)在第一時間段內使能量傳遞增加至預定第一功率位準;(b)將能量傳遞維持在該第一功率位準歷時第二時間段;及(c)若在該第二時間段之後溫度值小於預設臨限值溫度,則將能量傳遞增加至第二預定功率位準;且其中該能源進一步包含一組件,其經組態以(d)獲得一組對應於使用該導管、該能源及該能量傳遞元件進行之完全治療的治療資料;(e)根據一或多個標準估算該組治療資料以確定該完全治療之估值是否可能在預定範圍內;及(f)提供關於該完全治療之估值是否可能在該預定範圍內之指示。
- 如申請專利範圍第1項之系統,其中該組治療資料為對應於第一完全治療之第一組治療資料,且其中該系統經 進一步組態以(a)至少部分地基於對該第一治療資料之估算及關於該第一完全治療之該估值是否在該預定範圍內之該指示修改該第一預定功率位準、該第一時間段、該第二時間段及/或該第二預定功率位準;(b)使用經修改之第一預定功率位準、經修改之第一時間段、經修改之第二時間段及/或經修改之第二預定功率位準進行第二治療;及(c)獲得對應於第二完全治療之第二組治療資料。
- 如申請專利範圍第1項之系統,其中該組治療資料包含關於基於溫度之量測值、基於阻抗之量測值、基於血流量之量測值或基於移動之測定值中之一或多者的資料。
- 如申請專利範圍第1項之系統,其中該組治療資料包含一或多個關於以下之量測值:指定時間內之溫度變化、最大溫度、最大平均溫度、最小溫度、在預定或計算時間相對於預定或計算溫度之溫度、指定時間內之平均溫度、最大血流量、最小血流量、在預定或計算時間相對於預定或計算血流量之血流量、隨時間變化之平均血流量、最大阻抗、最小阻抗、在預定或計算時間相對於預定或計算阻抗之阻抗、指定時間內之阻抗變化或指定時間內相對於溫度變化之阻抗變化。
- 如申請專利範圍第1項之系統,其中:該能量傳遞元件包含一第一能量傳遞元件,且其中該導管進一步包含一耦接至該能源且經組態以將能量傳 遞至所述目標神經纖維的第二能量傳遞;且該組治療資料包含關於該第一能量傳遞元件之基於阻抗之量測值的第一組資料及關於該第二能量傳遞元件之基於阻抗之量測值的第二組資料。
- 如申請專利範圍第5項之系統,其中根據一或多個標準估算該組治療資料包含將該第一組資料與該第二組資料相比較。
- 如申請專利範圍第1項之系統,其中估算該組治療資料包含產生一用以確定該完全治療是否成功之分值。
- 如申請專利範圍第1項之系統,其中估算該組治療資料包含執行線性判別分析。
- 如申請專利範圍第8項之系統,其中該線性判別分析產生一用以確定該完全治療是否成功之分值。
- 如申請專利範圍第1項之系統,其進一步包含一顯示螢幕,且其中所提供之指示包含在該顯示螢幕上顯示之訊息。
- 如申請專利範圍第10項之系統,其進一步包含一用於量測治療部位或電極之阻抗的阻抗感應器,且其中該能源經進一步組態以在選定時間段內追蹤即時阻抗量測值且在該顯示螢幕上顯示該即時阻抗量測值。
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EP (2) | EP2632373B1 (zh) |
JP (3) | JP6046041B2 (zh) |
CN (2) | CN103313671B (zh) |
TW (1) | TWI513451B (zh) |
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JP2017080420A (ja) | 2017-05-18 |
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CN107007348A (zh) | 2017-08-04 |
JP6267774B2 (ja) | 2018-01-24 |
EP3449856A1 (en) | 2019-03-06 |
US20120101538A1 (en) | 2012-04-26 |
CN103313671A (zh) | 2013-09-18 |
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CN107007348B (zh) | 2019-05-31 |
JP2018079334A (ja) | 2018-05-24 |
US11006999B2 (en) | 2021-05-18 |
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