TW200416013A - Radiofrequency thermal balloon catheter - Google Patents

Radiofrequency thermal balloon catheter Download PDF

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Publication number
TW200416013A
TW200416013A TW92103941A TW92103941A TW200416013A TW 200416013 A TW200416013 A TW 200416013A TW 92103941 A TW92103941 A TW 92103941A TW 92103941 A TW92103941 A TW 92103941A TW 200416013 A TW200416013 A TW 200416013A
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Taiwan
Prior art keywords
balloon
radio
sleeve
electrode
liquid
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TW92103941A
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Chinese (zh)
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TW584552B (en
Inventor
Shutaro Satake
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Shutaro Satake
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Priority claimed from JP2001303112A external-priority patent/JP3607231B2/en
Application filed by Shutaro Satake filed Critical Shutaro Satake
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Publication of TW584552B publication Critical patent/TW584552B/en
Publication of TW200416013A publication Critical patent/TW200416013A/en

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Abstract

A radiofrequency thermal balloon catheter makes it possible to heat uniformly the tissues in contact with the balloon and to achieve thermotherapy such as ablation or hyperthermia safely and properly for a diseased part. A radiofrequency thermal balloon catheter includes a catheter (4) consisting of an outer shaft (2) and an inner shaft (3) extended through the outer shaft so as to be slidable relative to the outer shaft, an inflatable balloon (6) capable of being inflated so as to be in contact with a target lesion (18) and equipped between respective front end parts of the outer and the inner shaft, a radiofrequency electrode (8) extended in a wall of the balloon or inside the balloon to be used for radiofrequency energy supply in combination with a counter electrode (53), the counter electrode being disposed at a predetermined position, for example, inside the balloon, in the wall of the balloon, in the position neighboring the balloon or on the patient's body surface, a lead wire (10) electrically connected to the radiofrequency electrode, a temperature sensor (12) capable of sensing temperature of a liquid contained in the balloon, and a temperature distribution uniformizing means such as a revolving structure (14) for uniformizing temperature distribution in the liquid contained in the balloon.

Description

i 200416013 玖、發明說明 (發明說明應敘明:發明所屬之技術領域、先前技術、内容、實施方式及圖式簡單說明) C發明戶斤屬之技術領域3 發明領域 本發明是有關於一種射頻式熱氣球導管(RTBC),更詳 5 言之,是有關於一種射頻式熱氣球導管用以作心血管疾病 之治療。i 200416013 发明 Description of the invention (The description of the invention should state: the technical field to which the invention belongs, the prior art, the content, the embodiments, and a brief description of the invention) C. The technical field of the invention 3 The field of the invention The invention relates to a radio frequency Hot Air Balloon Catheter (RTBC), more specifically, 5 is a radio frequency hot air balloon catheter for the treatment of cardiovascular diseases.

發明背景Background of the invention

使用一膨脹氣球,且藉供應射頻式能量於電極以加熱 10 與氣球接觸之組織用以治療可產生射頻電場之治療方法, 揭露於如核准予本發明申請人之日本專利號2538375、 2510428及2574119。與該氣球接觸之組織必須被均勻地或 同質地加熱以滿意地達到治療法。然而,形成該電極之電 極線無法均勻地配置於該氣球内。若該電極之線被不規則 15配置時,則容納於該氣球内之液體被不規則或不同質地加 熱。容納於該氣球内之液體的局部溫度差亦會因對流及該 氣球内上部的溫度變高而增加。如此,於該氣球内分布會 無法避免地不規則或不同質。因此,於該氣球接觸之組織 無法均勻加熱。 20 C 明内】 發明概要 據此,本發明之目的在於解決上述習知的問題,即在 提供-種射頻式熱氣球導管,可使與該氣球接觸之組織均 勻加熱,以達到溫熱療法,如安全地脫落或過高熱,且適 5 416013 玖、發明說明 當地用於一害病部位。 根據本發明,-種射頻式熱氣球導管包含有··一導管 ,由-外桿及-内桿所構成,該内桿延伸穿過該外桿以可 相對於該外桿滑動;-膨脹氣球,可膨服以與一目桿哭官 5損害部相接觸且設置於該外桿及該内桿的個別端部 -射頻電極,用以與-反電極結合作射頻能量供應,延伸 於該氣球之-壁部内或該氣球内部,該反電極設置於一預 疋位置;一引線,電連接於該射頻電極;一溫度感測器, 可感測容納於該氣球内的液體之溫度;及一溫度分布均句 10化1置,用以使容納於該氣球内的液體之溫度分布均勾化 〇 該溫度分布均勻化裝置使容納於該氣球内的液體之溫 度分布均勻化’以防止容納於該氣球内的液體因對流或類 似者產生不規則溫度分布,因此與該氣球接觸之目標器官 15損害部可藉射頻加熱均勾加熱。由於容納於該氣球内的液 體中溫度分布可被均勻化,因此由該溫度感測器量測的液 體溫度可準確與該目標器官損害部的溫度一致,且因此可 精確控制該目標器官損害部的溫度。 該溫度分布均勻化裝置可為一攪動裝置,用以攪動容 20納於該氣球内的液體。該授動裝置授動㈣體以使該液體 内的溫度分布均勻。 該射頻式熱氣球導管可進一步包括··一轉動前套管, 放置於該内桿之一前端部上,以繞該導管的軸心轉動,·一 轉動後套管,放置於該外桿之一前端部上,以繞該導管的 6 416013 坎、發明說明 #由心轉動,及一轉動基本套管, 得住該引線以致於可供應 射頻此置於該引線且該引線 八了破轉動;其中該射頻電極包 各數電極線,以相互平行延柚 •#;该轉動前套管與該轉動後 套g之間,及該攪動裝置包含一 $ 6 疋軚驅動I置,用以驅動 ^射頻電極、該轉動前套管 + 谷動後套官、該引線及該 轉動基本套管以使其轉動。 該攪動裝置之旋轉驅動梦罢 動衣置驅動該射頻電極、該轉動 月'j套官、該轉動後套管、該引 ίο 、良及忒轉動基本套管以使其 以於射頻能量供應期間轉動該射頻電極。因此,可 達到均勻的射頻能量供應,且藉 ^轉動射頻電極的攪動作 用该液體的溫度分布可均勻化。 二該射頻電極包含數電極線,以相互平行連接於該轉動 别套官及該轉動後套管。因此該射頻電極可輕易形成且可 均句地分布於該氣球内。 15 較佳地,形成該射頻電極之該等線性延伸電極線可被 考曲成一圓弧形狀’以當該外桿及該内桿相互軸向移動以 使该氣球膨脹時可沿該氣球的一内表面延伸。 。容納於該氣球内之該液體可藉轉動該射頻電極彎曲成 圓弧形狀之該等電極線被有效地授動,且可產生均 電場。 負 線 該引線可螺旋盤繞,且該旋轉驅動裝置可轉動該引 以轉動該射頻電極。 當該螺旋盤繞引線被以一方向轉動時,該螺旋盤繞引 線當該旋轉驅動裝置停止轉動該螺旋盤繞彳丨線時,可^其 7 20 玖、發明說明 本身彈性而以另一相反方向轉動以回復其自然形狀。 該旋轉驅動裝置可驅動該轉動前套管、該轉動後套管 、該引線及該轉動基本套管’以使其以相反方向交互轉動 ’且可藉於各該料目反方向預定的轉數,於轉動該轉動前 套管、該轉動後套管、該引線及該轉動基本套管之後改變 该引線及該轉動基本套管 该轉動前套管、該轉動後套管 之轉動方向。因此,該射頻電極可於相反方向簡單地交互 軺動,以藉該射頻電極攪動容納於該氣球内的液體。 該攪動裝置可包含一連接管,連接於該外桿,藉一由 該外桿與該内桿界;t之通道而與該氣球連通,·及—㈣產 生衣置’用以將震動力料填滿於該連接管及該通道之液 體。 5亥震動產生裝置將震動力施予填滿於該連接管及該通 道之液體’域等震動力被散播至容納於該氣球内的液體 且攪動容納於該氣球内之液體以使容納於該氣球内之液體 的溫度分布均勻化。 α亥展動產生裝置將震動力施予填滿於該連接管及該通 這之液體’以致於使容納於該氣球内之液體中產生旋渴。 谷納於該氣球内之液體中所產生之漩渦,可有效使容 納於該氣球内之液體的溫度分布均勻化。 各納於該氣球内之液體的溫度分布可藉該循環裝置以 一固定溫度循環該液體而使其均勻化。 σ亥内杯延伸於該氣球内之一部位可設置數小喷嘴,且 /衣衣置可包含_液體供應裝置,可供應該液體至該内 玖、發明說明 内 ::,由該等小”噴射該液體且可經 界疋之蝴a W彻㈣體。^ 該液體供應裝置可唾 且可經由^卜^ "叫之小”料該液體, 。 料及⑼桿所界定之_道转取得該液體 内部之 置於該氣球内用以 _«極繞於該内桿延伸於該氣球 立因此,该射頻電極可輕易地設 南效率射頻加熱。 该氣球可以抗血栓形成(antithromb ogenic)、熱阻及撓 性樹脂所形成。該氣球可適意符合所有必須特質。 β忒預疋位置可為於病人身體上的一位置,且該反 是附著於病人身體上。 及預疋位置可為於該氣球的一壁部内或該氣球 一位置。 電極 之 該預定位置可為鄰近於該氣球之一位置。 圖式簡單說明 本發明之上述及其他目的、特徵及優點將由以下詳細 說明,並配合參考圖式而得以瞭解,其中·· 第1圖是根據本發明第一實施例的射頻式熱氣球導管 一前部之示意透視圖; 第2圖是該射頻式熱氣球導管連續於第丨圖所示的射 頻式熱氣球導管前部之後部之示意透視圖; 第3圖疋用以說明該射頻式熱氣球導管於應用於作心 房纖維顫動治療的肺血管之電隔離的操作之示意圖; 200416013 玖、發明說明 第4(a)及4(b)圖是一氣球導管的示意圖,分別是於該 氣球被壓縮用以插入於肺血管内的狀態,及於該氣球膨服 以與一目標器官損害部接觸的狀態; 第5圖是根據本發明第二實施例的射頻式熱氣球導管 5 之示意透視圖; 第6⑷及6(b)圖是第5圖所示該射頻式熱氣球導管的 示意圖,分別是於-氣球被壓縮用以插入於股動脈内的狀 態,及於該氣球膨脹以與一目標組織鄰近處接觸的狀態; 第7圖是用以說明一熱氣球導管用於治療動脈硬化症 10 的使用之示意圖;及 弟8圖是根據本發明第三實施例的射頻式熱氣球導管 之部分圖。 I:實施方式孺 較佳實施例之詳細說明 15 根據本發明第—實施例中之射頻式熱氣球導管將參考 第1至4圖詳述之。如第 球導管1包含一導管4, 1及2圖所示,一種射頻式熱氣 其由一外桿2及延伸於該外桿2 一内杯3所構成,一可膨脹氣 器吕才貝害部接觸且延伸於該外 一射頻電極8設置於該氣球6 内以相對於該外桿2滑動之 球6,其可膨脹以與一目標 桿2與内桿3的端部之間, 内,一引線10 ’其電連接於該射頻電極8,一熱電偶U放 置;氣托6 Θ且可感應該氣球6 Θ的溫度,及—檀動裝 置14 ’即—溫度分布均勻化裝置,用以使容納於該氣球6 内的液體溫度均句分布。一導線16延伸穿過該内桿3實質 10 20 416013 坎、發明說明 上與该導官4同軸。該導線16導引該導管4。 么一轉動前套管20放置於該内桿3延伸於該氣球6内之A treatment method using an inflatable balloon and supplying radio frequency energy to an electrode to heat 10 tissues in contact with the balloon to treat a radio frequency electric field is disclosed in Japanese Patent Nos. 2538375, 2510428, and 2574119 as approved by the applicant of the present invention . The tissue in contact with the balloon must be heated uniformly or homogeneously to achieve the desired treatment. However, the electrode lines forming the electrodes cannot be uniformly arranged in the balloon. If the wire of the electrode is arranged irregularly, the liquid contained in the balloon is heated with irregularity or different texture. The local temperature difference of the liquid contained in the balloon also increases due to convection and the temperature of the upper part of the balloon becomes higher. As such, the distribution within the balloon will inevitably be irregular or heterogeneous. Therefore, the tissue contacted by the balloon cannot be heated uniformly. 20 C Ming Nai] Summary of the Invention Accordingly, the object of the present invention is to solve the above-mentioned conventional problem, that is, to provide a radio-frequency hot-air balloon catheter, which can uniformly heat the tissues in contact with the balloon to achieve thermotherapy, If it is safely detached or overheated, and suitable for 5 416013 玖, the invention shows that it is used locally in a diseased area. According to the present invention, a radio-frequency hot-air balloon catheter includes a catheter composed of an outer rod and an inner rod, the inner rod extending through the outer rod to be slidable relative to the outer rod; It can be inflated so as to be in contact with the damaged part of a cricket officer 5 and is provided on the outer rod and the individual end of the inner rod-a radio frequency electrode, which cooperates with a counter electrode to supply radio frequency energy and extends to the balloon. -Inside the wall or inside the balloon, the counter electrode is arranged at a pre-position; a lead wire electrically connected to the radio frequency electrode; a temperature sensor that can sense the temperature of the liquid contained in the balloon; and a temperature The distribution uniformity is set to 10 for uniformizing the temperature distribution of the liquid contained in the balloon. The temperature distribution homogenizing device uniformizes the temperature distribution of the liquid contained in the balloon to prevent the liquid contained in the balloon from being contained in the balloon. The liquid in the balloon has an irregular temperature distribution due to convection or the like, so the damaged part of the target organ 15 that is in contact with the balloon can be heated by RF heating. Since the temperature distribution in the liquid contained in the balloon can be uniformized, the temperature of the liquid measured by the temperature sensor can be accurately consistent with the temperature of the target organ damage portion, and therefore the target organ damage portion can be accurately controlled temperature. The temperature distribution homogenizing device may be an agitation device for agitating the liquid contained in the balloon. The actuating device actuates the carcass to make the temperature distribution in the liquid uniform. The radio-frequency hot air balloon catheter may further include a rotating front sleeve placed on a front end portion of the inner rod to rotate around the axis of the catheter, and a rotated rear sleeve placed on the outer rod. On a front end, 6 416013 kan, invention description # from the center of the catheter, and a basic sleeve is rotated to hold the lead so that RF can be supplied and placed on the lead and the lead is broken and rotated; The radio frequency electrode package includes several electrode wires extending parallel to each other. The rotating electrode sleeve and the rotating rear sleeve g are included, and the stirring device includes a $ 6 疋 軚 drive unit for driving ^ The radio frequency electrode, the rotating front sleeve + valley moving rear sleeve, the lead wire and the rotating basic sleeve make it rotate. The rotation drive of the agitation device drives the radio frequency electrode, the rotating moon's sleeve, the rotating sleeve, the lead, Liang and 忒 to rotate the basic sleeve so that it can be used during the RF energy supply period. Turn the RF electrode. Therefore, uniform RF energy supply can be achieved, and the temperature distribution of the liquid can be uniformized by the stirring action of rotating the RF electrode. Two of the radio frequency electrodes include a plurality of electrode wires, which are connected in parallel to the rotating sleeve and the rotating sleeve. Therefore, the RF electrode can be easily formed and evenly distributed in the balloon. 15 Preferably, the linearly extending electrode wires forming the radio frequency electrode can be curved into an arc shape so that when the outer rod and the inner rod move axially with respect to each other to expand the balloon, the The inner surface extends. . The liquid contained in the balloon can be effectively energized by rotating the radio frequency electrodes and the electrode wires bent into an arc shape, and can generate a uniform electric field. Negative wire The lead wire can be spirally wound, and the rotary driving device can rotate the lead to rotate the radio frequency electrode. When the helical coiled lead is rotated in one direction, when the rotary driving device stops rotating the helical coiled wire, it can be 7 20 玖, the invention description itself is elastic and can be rotated in the opposite direction to Restores its natural shape. The rotary driving device can drive the pre-rotating sleeve, the post-rotating sleeve, the lead wire and the turning basic sleeve 'to make them alternately rotate in opposite directions' and can be preset a number of revolutions in the opposite direction of each item. After rotating the pre-rotating sleeve, the post-rotating sleeve, the lead wire and the turning basic sleeve, the direction of rotation of the lead and the turning basic sleeve, the pre-rotating sleeve, and the post-rotating sleeve is changed. Therefore, the RF electrode can be simply and interactively moved in the opposite direction to agitate the liquid contained in the balloon by the RF electrode. The stirring device may include a connecting tube connected to the outer rod, and communicate with the balloon by a channel between the outer rod and the inner rod boundary; and-the "producing clothes" is used to fill the vibration force material Full of liquid in the connecting tube and the channel. The 5H vibration generating device applies a vibration force to the liquid filled in the connecting tube and the channel, and the vibration force is spread to the liquid contained in the balloon and agitates the liquid contained in the balloon so as to be contained in the balloon. The temperature distribution of the liquid in the balloon is uniform. The α-Hydraulic motion generating device applies a vibration force to the connection tube and the liquid ', so that thirst is generated in the liquid contained in the balloon. The vortex generated by Gu Na in the liquid in the balloon can effectively uniformize the temperature distribution of the liquid contained in the balloon. The temperature distribution of the liquid contained in the balloon can be made uniform by circulating the liquid at a fixed temperature by the circulation device. σHai Nei Cup extends to one part of the balloon. Several small nozzles can be set, and the clothes can include a _liquid supply device, which can be used for the liquid to the inside, the description of the invention :: by these small " The liquid is sprayed and can pass through the body of the butterfly. ^ The liquid supply device can spit and the liquid can be called through the "small". The liquid is defined by the material and the stalk to obtain the liquid inside the balloon and placed inside the balloon for the «« to extend around the inner rod and extend to the balloon. Therefore, the RF electrode can easily be set to a high efficiency RF heating. The balloon can be made of antithromb ogenic, thermal resistance and flexible resin. The balloon fits all the required qualities in a proper way. The β 忒 pre- 疋 position can be a position on the patient's body, and the position is attached to the patient's body. And the pre-crash position may be in a wall portion of the balloon or a position of the balloon. The predetermined position of the electrode may be a position adjacent to the balloon. BRIEF DESCRIPTION OF THE DRAWINGS The above and other objects, features, and advantages of the present invention will be described in detail below with reference to the drawings. Among them, FIG. 1 is a radio-frequency hot-air balloon catheter according to a first embodiment of the present invention. A schematic perspective view of the front part; FIG. 2 is a schematic perspective view of the radio frequency hot air balloon catheter continuously behind the front part of the radio frequency hot air balloon catheter shown in FIG. 丨; FIG. 3 is used to explain the radio frequency heat Schematic diagram of the balloon catheter used in the electrical isolation of pulmonary blood vessels for atrial fibrillation treatment; 200416013 发明, description of the invention Figure 4 (a) and 4 (b) are schematic diagrams of a balloon catheter. A state of compression for insertion into a pulmonary vessel, and a state where the balloon is inflated to contact a target organ lesion; FIG. 5 is a schematic perspective view of a radio-frequency hot-air balloon catheter 5 according to a second embodiment of the present invention Figures 6 (b) and 6 (b) are schematic diagrams of the radio-frequency hot-air balloon catheter shown in Figure 5, respectively, in the state where the balloon is compressed for insertion into the femoral artery, and when the balloon is inflated to match a mesh Fig. 7 is a schematic diagram for explaining the use of a hot-air balloon catheter for treating arteriosclerosis 10; and Fig. 8 is a radio-frequency hot-air balloon catheter according to a third embodiment of the present invention. Partial figure. I: Embodiment 孺 Detailed description of the preferred embodiment 15 The radio-frequency hot-air balloon catheter according to the first embodiment of the present invention will be described in detail with reference to FIGS. 1 to 4. As shown in the first ball duct 1 including a duct 4, 1 and 2, a radio-frequency hot gas is composed of an outer rod 2 and an inner cup 3 extending from the outer rod 2 and an expander Lu Caibei The ball 6 which is in contact with and extends from the outer RF electrode 8 is disposed inside the balloon 6 to slide relative to the outer rod 2, and is expandable to be between the end of a target rod 2 and the inner rod 3. A lead wire 10 ′ is electrically connected to the radio frequency electrode 8, and a thermocouple U is placed; the air cylinder 6 Θ can sense the temperature of the balloon 6 Θ, and—the moving device 14 ′, that is, the temperature distribution homogenizing device for The temperature of the liquid contained in the balloon 6 is evenly distributed. A wire 16 extends through the inner rod 3 substantially 10 20 416013 kan. The invention is coaxial with the guide 4. The guide wire 16 guides the catheter 4. When the front sleeve 20 is rotated, it is placed on the inner rod 3 and extended inside the balloon 6

月’J端口P上用以繞該導管4的軸心轉動。一轉動後套管U 放置於該外桿2之一前端部上用以繞該導管4的轴心轉動 二該:頻電極8包含數電極線8a以相互平行延伸於該轉動 則套管2〇與該轉動後套管21之間。該射頻電極8之電極 線8a $喊球6被壓縮時,以實質上線性延伸。當該氣球 6猎遠外桿2相對於該内桿3滑動而膨脹時,該等電極線 ίο 8a被-曲成一圓弧形狀,以沿該氣球6内表面延伸,如第 1圖所示。 ~動基本套f 23放置於該内桿3上以繞該導管4的 車由心轉祕近該外桿2後端的位置處。該轉動基本套管23 2、有病部設置有-環體24、-後端部設置有_接觸環 15 及一中間部設置有一齒輪26。-支撐於一集電弓上之 電刷29保持與該接觸環25接觸。 20 卜π、文3 1形成於該外桿2的一後端部上。一螺帽 32與:外螺紋31螺接。〇型環27放置於該轉動基本套管 乂在封料桿2内表面與該轉動基本套管23外表面之 ::的間隙而形成-水密型式。因此該轉動基本套管23鱼该 卜桿2之間的間隙,及該轉動基本套管23與該 之; 的間隙被密封成一水穷刑斗、 之間 ⑴1式。該内桿3延伸穿過該轉動前 ^ 0边轉動後套管21及該轉動基本套管23。一外螺 、、文33形成於該轉動基本套管23的-後端部上,且_ 34與該外螺紋33蟫接 丁目 ‘接。一 〇型環28密封該内桿3外表面 11 玖、發明說明 …亥轉動基本套管23内表面之間的間隙形成—水密型式。 引線10主螺方疋狀盤繞。該引線工〇使其一端連接於 ^轉動後套管2卜其另—端連接於該接觸環25。與該接觸 $環h保持接觸之該電刷29電連接於一射頻產生器4〇。由 7射颈產生态40產生的射頻能量經由該引線1〇供應於該 射頻電極8。該射頻產生器供應⑽MHz的射頻電流於該 射頻電極8與-附接於病人身體表面上的反電極(第3 圖)之間。舉例來說,當該氣球6的直徑約為2.km時供 應具10G至2GGW輸出的射頻能量予該射頻電極卜當射 1〇頻電流供應於該射頻電極8與附接於病人身體表面上的該 反電極53之間呤’與該氣球6接觸之組織} 8藉附有射頻 電介質加熱之電容型式加熱而被燒灼。該電介質加熱是於 該氣球6内部環繞該電極8且與不同電介質常數成比例的 產生。因此,與該氣球6接觸之該等組織Μ被燒灼是根據 U射頻加熱的原理,即熱是分別具有不同電介質常數之電介 質構件的接觸部上產生。 —具有#輪36及37與一馬達38之減速齒輪^設置 近於該齒輪26。該馬達38的輸出軸的旋轉經由該等齒輪 36及37傳送-較低速度於該齒輪%。該馬達%可被控制 2〇使其輸出軸以於單一方向之預定轉數的方式旋轉,或可被 控制使其輸出軸以於順時針方向二滿轉數及於反時針方向 二滿轉數交互的方式旋轉。 該引線10係以稍微堅硬材質形成。當該馬達%驅動 固定於該齒輪26之該轉動基本套管23時,連接於該環體 12 200416013 玖、發明說明 24之該引線1〇被轉動,且因此,該轉動後套管21、該射 頻電極8及該轉動前套管2〇可被轉動。 當該馬達38被控制以使該引線1〇以單一方向轉動一 預定轉數時,該引線以與該引線10螺旋盤繞的方向相 5反的方向轉動。當該馬達38於轉動該引線1〇 —預定轉數 之後彳T止日守,该引線10會以相反方向自動轉動以回復其原 來形狀。该射頻電極8可藉交互起動及停止該馬達%而以 相反方向交互轉動。當該馬達38被控制使其輸出軸以於順 柃針方向一滿轉數及於反時針方向二滿轉數交互旋轉時, 10 4引線1G係以彈性材質形成_平直形狀以使該射頻電極8 以相反方向交互轉動。 錢動裝f 14,即-溫度分布均句化裝置,包含該轉 動前套管20、該轉動後套管21、該轉動基本套管Μ及該 馬達38 ’以轉動該射頻電極8。該引線1G將該馬達38的 15方疋轉驅動力傳达於該射頻電極8,且將由該射頻產生器仙 產生的射頻能量傳送於該射頻電極8。該攪動裝置Μ用以 減除產生於該氣球6内的局部溫度差,且賴動裝置14使 該氣球6内部液體的溫度分布均勻。 刀支官51連接於該外桿2之―後端部。該分支管 2〇 ^二置有—通氣管及-對比劑供應管。該分支f51的通 丁開以使4乳球6排氣,且之後其對比劑供應管被 打開:供應液體,例如生理食鹽溶液,供應於該氣球6内 以將該氣球6膨脹。Month ' J port P is used to rotate about the axis of the catheter 4. After the rotation, the sleeve U is placed on one of the front ends of the outer rod 2 for rotation around the axis of the catheter 4. The frequency electrode 8 includes several electrode wires 8a so as to extend parallel to the rotation and the sleeve 2. And the sleeve 21 after the rotation. When the electrode wire 8a of the radio frequency electrode 8 is compressed, it extends substantially linearly. When the balloon 6 expands while the outer rod 2 slides relative to the inner rod 3, the electrode wires 8a are curved into an arc shape to extend along the inner surface of the balloon 6, as shown in FIG. The moving basic sleeve f 23 is placed on the inner rod 3 to turn the cart around the catheter 4 from the heart to the position near the rear end of the outer rod 2. The rotating basic sleeve 23 2. The diseased part is provided with a ring body 24, the rear end part is provided with a contact ring 15 and a middle part is provided with a gear 26. -A brush 29 supported on a pantograph remains in contact with the contact ring 25. 20 Bu π, Wen 31 is formed on a rear end portion of the outer rod 2. A nut 32 is screwed with the external thread 31. The O-ring 27 is placed on the rotating basic sleeve 乂 to form a water-tight type in the gap between the inner surface of the sealing rod 2 and the outer surface of the rotating basic sleeve 23 ::. Therefore, the gap between the rotating basic sleeve 23 and the butt 2 and the gap between the rotating basic sleeve 23 and it are sealed into a water torture bucket, and the type 1 is used. The inner rod 3 extends through the rotating sleeve 21 and the rotating basic sleeve 23 before the rotation. A male screw 33 and a male screw 33 are formed on the rear end of the rotating basic sleeve 23, and _34 is connected to the male screw 33. A 10-ring 28 seals the outer surface of the inner rod 3 11 发明, description of the invention ... The gap formed between the inner surfaces of the basic sleeve 23 by rotation is a water-tight type. The lead 10 is coiled in a main spiral. The lead wire has one end connected to the sleeve 2 after rotation and the other end connected to the contact ring 25. The brush 29, which is in contact with the contact $ ring h, is electrically connected to a radio frequency generator 40. The radio frequency energy generated by the 7-neck generation state 40 is supplied to the radio frequency electrode 8 through the lead 10. The RF generator supplies a RF current of ⑽MHz between the RF electrode 8 and a counter electrode (Fig. 3) attached to the surface of the patient's body. For example, when the diameter of the balloon 6 is about 2.km, radio frequency energy output from 10G to 2GGW is supplied to the radio frequency electrode, and 10 radio frequency current is supplied to the radio frequency electrode 8 and attached to the surface of the patient The tissue between the counter electrode 53 and the balloon 6 that is in contact with the balloon 6} 8 is burned by a capacitive type heating with radio frequency dielectric heating. The dielectric heating is generated around the electrode 8 inside the balloon 6 and is proportional to different dielectric constants. Therefore, the tissues M in contact with the balloon 6 are cauterized according to the principle of U radio frequency heating, that is, heat is generated on the contact portions of the dielectric members having different dielectric constants, respectively. -A reduction gear with #wheels 36 and 37 and a motor 38 is provided close to the gear 26. The rotation of the output shaft of the motor 38 is transmitted via the gears 36 and 37-a lower speed than the gear%. The motor% can be controlled to make its output shaft rotate at a predetermined number of revolutions in a single direction, or it can be controlled to make its output shaft at two full revolutions in the clockwise direction and two full revolutions in the counterclockwise direction. Rotate interactively. The lead 10 is formed of a slightly hard material. When the motor% drives the rotating basic sleeve 23 fixed to the gear 26, the lead wire 10 connected to the ring body 12 200416013 玖, invention description 24 is rotated, and therefore, after the rotation, the sleeve 21, the The RF electrode 8 and the sleeve 20 before the rotation can be rotated. When the motor 38 is controlled to rotate the lead wire 10 in a single direction by a predetermined number of revolutions, the lead wire is rotated in a direction opposite to the direction in which the lead wire 10 is spirally wound. When the motor 38 rotates the lead wire by 10 to a predetermined number of rotations, the lead wire 10 will automatically rotate in the opposite direction to return to its original shape. The RF electrode 8 can alternately rotate in the opposite direction by alternately starting and stopping the motor%. When the motor 38 is controlled so that its output shaft rotates with one full revolution in the clockwise direction and two full revolutions in the counterclockwise direction, the 10 4 lead 1G is formed of an elastic material _ straight shape to make the radio frequency The electrodes 8 alternately rotate in opposite directions. The moving device f 14, which is a temperature distribution homogenization device, includes the pre-rotating sleeve 20, the post-rotating sleeve 21, the turning basic sleeve M, and the motor 38 'to rotate the radio frequency electrode 8. The lead wire 1G transmits the 15-square-turn driving force of the motor 38 to the radio frequency electrode 8, and transmits radio frequency energy generated by the radio frequency generator 8 to the radio frequency electrode 8. The agitation device M is used to reduce the local temperature difference generated in the balloon 6, and the agitation device 14 makes the temperature distribution of the liquid inside the balloon 6 uniform. The knife support 51 is connected to the rear end portion of the outer rod 2. The branch tube 20 is provided with a vent tube and a contrast agent supply tube. The branch f51 is opened to vent the 4 milk balls 6 and then the contrast agent supply pipe is opened: a liquid, such as a physiological salt solution, is supplied into the balloon 6 to expand the balloon 6.

該内桿3設置有二内腔 即第一及第二内腔。該第一 13 200416013 玖、發明說明 内腔是使用作為用以延伸該導線16的空間及用於液體的通 C 及第一内腔是使用作為用以延伸導體的空間,該導體 用以傳送由附接於該内桿3露出段的中間部的該熱電偶12 所提供之訊號。 5 谷納於該氣球6内之液體的溫度是以附接於該内桿3 之熱電偶12量測。該熱電偶12的導體延伸穿過該内桿3 的第二内腔,且連接於一溫度計42。該溫度計42指示容 納於該氣球6内之液體的溫度。 該氣球6係以熱阻、撓性、抗血栓形成 1〇 (antlthr〇mbo§enic)樹脂所形成。於一膨脹狀態時,該氣球 6具有一類似洋蔥頭形狀,如第1圖所示。 該射頻電極8包含該等數電極線8a。該等電極線8a 的數目是幾個至幾十個的範圍中。當該内桿3相對於該外 桿2軸向移動以減少該轉動前套管2〇與該轉動後套管η 15之間的區間時,該等實質上線性電極線“被彎曲成圓弧形 狀,以致於該射頻電極8呈現大致類似籃子或洋蔥頭的形 狀。若該等電極線8a以形狀記憶合金所形成,該等電極線 8a可精確改變其形狀於實質上線性形狀與圓弧形狀之間。 該等電極線8a的前及後端部被覆有樹脂,以防止該等電極 20線8a的前及後端部之過度射頻加熱。 忒射頻產生40供應在兆赫等級上的射頻電力,例如 13·56ΜΗζ,至該射頻電極8。藉此,熱可藉電容射頻加熱 於病人身體一部位而產生於該射頻電極8與附接於病人背 部表面的反電極53之間,如第3圖所示。 14 200416013 玖、發明說明 該射頻電極8藉該螺旋引線1〇連接於該轉動基本套管 23的接觸冑25。支樓於集電弓上且連接於該射頻產生器 40之該電刷29保持與該接觸環25接觸以將射頻能量供應 至該射頻電極8。該射頻電極8被轉動以產生更進一步均 勻的射頻電場繞於該射頻電極8。 ίο 15 該減速齒輪35減低輸入速度’即該馬達%輸出軸的 旋轉速度’成較低輸出速度。該馬達38的旋轉力被經由該 減速齒輪35、該齒輪26傳送至該轉動基本套管23。該轉 動基本套管23的旋轉藉該引線1〇傳送至該轉動後套管21 以轉動該氣球6内之電極線8a。因此’填滿於該膨服氣球 6内之液體被該等電極線6a授動,以防止因對流之不規則 的溫度分布及使填滿於該氣球6的液體的溫度均勾化分布 口此於.亥氣球6的中央區域内之液體的溫度、於該氣 球6壁部鄰近處之液體的溫度,及於與該氣球6接觸的組 織18之溫度可均等。因此,於該氣球6的t央區域内之液 體’以該熱電偶12量測且以該溫度計42指示之溫度,可 精確代表與該氣球6接觸的_之溫度。 20 該液體的溫度是當該射頻能量被供應於該射頻電極8 時以設置於該内桿3露出段内之該熱電偶12量測而得,且 韻頻產生器40的輸出是以一反饋控制模式控制以致於填 滿於該氣球6的液體可於—最佳溫度加熱。因此,與該氣 球6接觸的組織18可於-最佳溫度加熱。 該轉動籃狀射頻電極8產生一更均勾射頻電場,且授 動填滿於該氣球6的液體。因此’於該液體内的溫度分布 15 5 玖、發明說明 可均句且與該氣球6接觸的組織18可精確加熱於所要溫度 應用於肺jk官之電隔離以作心房纖維顫動之治療。 10 15 20 第3圖是用以解釋說明燒灼環繞於肺血管17的毛孔 之、房19的組織18之作動。將生理食鹽溶液通過該 勺刀支& 51供應於該氣球6内及將生理食鹽溶液吸 =該氣球6外之循環重覆幾次以淨化該氣球6的空氣。如 f 4⑷圖所示,該氣球6被壓縮且該内桿3被自該外桿2 几王伸出,以致於該轉動前套管2G與該轉動後套管^之 間的距騎加至_限度,且該射頻電極8的電極線h於將 -亥射頻式熱氣球導管丨插人於肺血f 17内之前,以實質上 線性延伸。於此狀態,該氣球6的直徑降低至最低。缺後 ’該氣球6被插人於肺血管17内。操作該射頻式熱氣球導 官1以將該氣球6安置於近該等目標組織18。然後,如第 4_所示,撤出該内桿3,將對比劑及生理食鹽溶液經由 該分支管51供應於該氣球6内以將該氣球6膨脹。由於該 轉動前套管20被移動向該轉動後套管2卜因此該等電極 線8a被相成圓弧形狀。藉此,該射頻電極$被以藍子形 狀伸跡該氣球6内。該射頻式熱氣球導管i持續地操作 以使該氣球6與該等目標組織丨8接觸。 之後,起動該馬達38以驅動該轉動基本套管23用以 藉由該減速齒輪35轉動。該轉動基本套管23的轉動力藉 延伸穿過該導管4之該螺旋引線10被傳送至該轉動後套‘ 16 玖、發明說明 21。因 J:卜,|、/ Λ/τ 好形狀伸展於該氣球6内之該射頻電極8 被幹動以攪動填滿於該氣球6内的液體。 的射=該射頻產生器40將一射頻電流’如13·5_ 應用於附著於病人背部之該反電極53,與連 式熱氣球導管1以籃子形狀伸展之該射頻電極 ^ % 25之間。一射頻電流流經該電刷29以與該接 10 觸衣25接觸。因此,該氣球6及與該氣球6接觸之該等組 被附有射頻電介質加熱之電容型式加熱而被加熱。僅 二於^球6内—上區域的溫度,若容納於氣球6内的液 體不峨時會因對流而較該氣球6内一下區域為高,容 、’、内於η亥亂球6内之液體的溫度分布,可因藉以籃子形狀伸 展的該轉動射頻電極8來攪動該液體而均勻。若該射頻電 15 °、…孔球6對準且固持於該氣球6内,則該等組織 18會被不規則加熱。由於該射頻電極8被加熱,因此可產 f均勻射頻電場環繞於該射頻電極8,且該氣球6及該 等組織18藉射頻加熱而均勻地加熱。 20 ^亥氣球6近該等轉動套管2〇及21供該等電極線以聚 的4刀具有一過熱傾向。如此過熱可藉使該等轉動 套s 20及21以具有小電介質常數的材質形成來避免,例 如樹月曰或陶究材質’及/或藉在該等電極線的部位被覆 有樹脂來避免,及/或藉循環冷卻水通過該内桿3來避免。 因此,肺灰管17可藉燒灼該心㈣繞於肺血管厂的 環形部位之組織18而被電隔離,以對病人作心房纖維顫動 之安全治療。 17 200416013 玖、發明說明 ίο 根據本發明一第二實施例之射頻式熱氣球導管1詳述 方、后4射頻式熱氣球導管i包含一循環系統用以循學 今納於-氣球6内的液體以使液體溫度分布均勻化。—内 桿3延伸於該氣球6内的部分設置有數小喷嘴64。該循環 不、充6〇包3 一溫度控制器66用以使一液體保持被供應於 /内才干3内,例如37 C的液體,及一液體供應裝置62,可 將受該溫度控制器66控制之預定溫度的液體供應於該内桿 3内,且可將嘴射通過該等小嘴嘴64之液體經由該内桿: 2-外桿2之間的環形空間吸入該氣球6内。當該氣球6 祕時,該氣球6具有一猶圓球形狀。一射頻電極8繞該 内桿3延伸於該氣球6内的部位螺旋盤繞。該射頻電極8 藉-引線1〇連接於一射頻產生器4〇。容納於該氣球㈣ 的液體之溫度係以一熱電偶12所量測,且以相似於上述第 15 1施例的方法監控,且用以供應於該射頻電極8的射頻 能量係根據所量測的溫度來控制。 2〇 如第5圖所示,受該溫度控制器66控制於例如37t 之—循環液體70被於44t㈣,而同時該循環液體%流 經该内桿3延伸於該氣球6内的部位且噴射通過該等小噴 嘴64而流人該氣球6内。噴射於該氣球㈣的該循環液體 7〇之溫度掉至43.5t且當該循環液體7〇到達該外桿2前 端時再進-步掉至价。藉此該循環液體%被該循環系 殊6〇循環以使容納於該氣球6内的液體均句地保持㈣ 43.5QC。 將 以下詳細說明如第5 錢球導管丄 18 200416013 玖、發明說明 應用於動脈應用部位之藥物治療上,如第7圖所示。 该射頻式熱氣球導管1的氣球6被I縮,且該射頻式 熱氣球導管!插穿於頸動脈的害病部位68内股動脈,如第 6⑷圖所示。然後,一對比劑及-生理食鹽溶液供應通過 一附接於該外桿2上的分支管51而供應於該氣球6内。因 此’該氣球6膨脹以伸展該害病部位68的狹窄部位,如第 W圖所示。於此狀態時,起動施一 i3 56MHz的射頻電壓 橫過該射頻電極8及附著於病人背部的反電極53。 ίο 15 鲁 該猶環系統60藉加麼將例如3η:之循環液體7〇供應 於相# 3的内腔内。被射頻加熱之該循環液體μ被喷射 穿過該等小噴嘴64而噴人該氣球6内。該循環液體7〇流 絰4軋球6,以使該氣球6内均勻化溫度分布,且被放出 通過該外桿2的内腔。當該氣球6被維持在43 5。〇2〇分鐘 或更久時,頸動脈的動脈粥樣硬化損害部位68内之發炎性 細胞或增生平滑肌細胞會進行計劃性細胞凋亡(―㈣, 且頸動脈之動脈粥樣硬化損害部位68可穩定。之後,該氣 球6被壓縮,且該射頻式熱氣球導管i自股動脈撤出。 該射頻式熱氣球導管i可於一最佳溫度下均勻地加熱 害病部位68的組織。因此,頸動脈的動脈粥樣硬化損害部 位68可經由該等發炎性細胞或增生平滑肌細胞之巨噬細胞 ,即不女疋因子之计劃性細胞凋亡(ap〇t〇sis)而可穩定化, 其是藉將頸動脈的動脈粥樣硬化損害部位68於43.5t加熱 20分知或更久,而不會影響正常組織,例如内皮。 該射頻式熱氣球導管丨可應用於癌症之過高熱 19 20 200416013 玖、發明說明 (hyperthermia)。事實證明癌症細胞可藉將其加熱於43.5。〇 20分鐘或更久而被控制或根絕。 如第8圖所示是顯示根據本發明第三實施例的射頻式 熱氣球導官1 ’該射頻式熱氣球導管1包含一氣球6及一 授動哀置80,用以攪動容納於該氣球6内的液體至使該液 體的溫度分布均勻化。 10 15 該攪動裝置80包含一連接管82連接於一外桿2以開 放形成—以該外桿2所界定之環形通道83,及-内桿3延 伸通過違外# 2,及_震動產生器、81,例如—震動產生隔 板泵’⑽震動力至填滿於該環形通道83内之液體。該連 接官82藉由該環形通道83與該氣球6相連通。由該震動 產生益81產生如約1Hz的震動力%經由填滿於該連接管 〃、4¼形通道83的液體散播。因此,容納於該氣球6 内的/夜體曰因β亥授動液體與重力之間互動而產生旋涡85。 這f旋渦經由運行中不定方向_該液體,以致於容納於 :孔求6内之’夜體的溫度分布可均勻化。藉此,形成於該 等組織68内的粉瘤可於一最佳溫度被同質加熱。 ”第5圖所不的射頻電極8相似,螺旋盤繞於該内桿 之射頻電極8是用以射頻加熱。 20 當該氣球6是 生咨81所產生的震 體中產生適度漩渦。 以適思撓性材質形成時,藉以該震動產 動力86 ,可使容納於該氣球6内的液 坩刖返可知,★政 敎 本务明之射頻式熱氣球導管可藉射頻2 u土溫度均勾加熱與該氣球相接觸的組織,且可; 20 200416013 玖、發明說明 全形成一貫穿三維壞死表層 不會因血栓形成或組織燒焦 而導致潰瘍。因此, 可安全且確實地達到心律不整的治療 ’例如自肺靜脈及其毛孔經由肺靜脈的隔離,以心臟期外 收縮所激發的心房纖維顫動。 由於該等組織可被於一最佳溫度均勻地加熱,因此藉 加熱-動脈硬化部位於_狀溫度以使不敎因子的内之 發炎性細胞或增生平滑肌細胞進行計劃性細胞〉周亡 (aPot議),可穩定該動脈硬化部,而不會影響正常組織, 例如内皮。 10 15 儘管本發明已以特定程度的特質詳細說明其較佳實施 例,很明顯地其中可作許多變更及變化。 舉例來况,純佳實施财該反電極%被附著於病人 身體的表面上。m反電極53所設置的位置並不偈限 於病人身體表面上。該反電極53亦可設置於該氣球的壁部 或該氣球内部’或者該反電極53亦可設置於鄰近該氣球的 — 知本發明可以不同於上述特定說明的方式 貫施,而不致脫離其範圍及精神。 【圖式簡軍說明】 20 一第1圖是根據本發明第一實施例的射頻式熱氣球導管 一前部之示意透視圖; ""圖疋4射頻式熱氣球導管連續於第 頻«氣球導管前部之後部之示意透視圖; 弟3圖是用以說明該射頻式熱氣球導管於應用於作心 21 200416013 玖、發明說明 房纖維顫動治療的肺血管之電隔離的操作之示意圖; 第4(a)及4(b)圖是一氣球導管的示意圖,分別是於該 氣球被壓縮用以插入於肺血管内的狀態,及於該氣球膨脹 以與一目標器官損害部接觸的狀態; 5 第5圖是根據本發明第二實施例的射頻式熱氣球導管 之示意透視圖; 第6(a)及6(b)圖是第5圖所示該射頻式熱氣球導管的 示意圖,分別是於一氣球被壓縮用以插入於股動脈内的狀 態,及於該氣球膨脹以與一目標組織鄰近處接觸的狀態; 10 第7圖是用以說明一熱氣球導管用於治療動脈硬化症 的使用之示意圖;及 第8圖是根據本發明第三實施例的射頻式熱氣球導管 之部分圖。 【圖式之主要元件代表符號表】 1…射頻式熱氣球導管 16…導線 2…外桿 17…肺血管 3…内桿 17註"-毛孑匕 4…導管 18…目標組織 6…氣球 19…心房 8…射頻電極 20…轉動前套管 8a…電極線. 21…轉動後套管 10…引線 23…轉動基本套管 12…熱電偶 24…環體 14…攪動裝置 25…接觸環 22 200416013 玖、發明說明 27,28...0 型環 70···循環液體 29…電刷 80…攪動裝置 31,33…外螺紋 81…震動產生器 32,34…螺帽 82…連捿管 35…減速齒輪 83"·環形通道 36,37…齒輪 85…旋渦 38…馬達 86…震動力 40…射頻產生器 42…溫度計 51…分支管 53…反電極 60…循環系統 62…液體供應裝置 64…噴嘴 66…溫度控制器 68…害病部位The inner rod 3 is provided with two inner cavities, namely a first and a second inner cavity. The first 13 200416013 发明, description of the invention The inner cavity is used as a space for extending the wire 16 and the liquid passage C and the first inner cavity is used as a space for extending a conductor for transmitting The signal provided by the thermocouple 12 attached to the middle of the exposed section of the inner rod 3. 5 The temperature of the liquid contained in the balloon 6 is measured by a thermocouple 12 attached to the inner rod 3. The conductor of the thermocouple 12 extends through the second inner cavity of the inner rod 3 and is connected to a thermometer 42. The thermometer 42 indicates the temperature of the liquid contained in the balloon 6. The balloon 6 is made of a thermally resistant, flexible, antithrombotic resin. In an inflated state, the balloon 6 has an onion-like shape, as shown in FIG. 1. The radio frequency electrode 8 includes an equal number of electrode lines 8a. The number of such electrode wires 8a is in the range of several to several tens. When the inner rod 3 moves axially relative to the outer rod 2 to reduce the interval between the pre-rotation sleeve 20 and the post-rotation sleeve η 15, the substantially linear electrode wires are “bent into a circular arc” Shape, so that the RF electrode 8 has a shape similar to a basket or an onion. If the electrode wires 8a are formed of a shape memory alloy, the electrode wires 8a can precisely change their shape to a substantially linear shape and an arc shape The front and rear ends of the electrode wires 8a are covered with resin to prevent excessive RF heating of the front and rear ends of the electrode wires 8a. 忒 RF generates 40 RF power supplied on the megahertz level, For example, 13.56MΗζ to the RF electrode 8. In this way, heat can be generated between the RF electrode 8 and the counter electrode 53 attached to the patient's back surface by heating the capacitor RF to a part of the patient's body, as shown in FIG. 14 200416013 发明, description of the invention The radio frequency electrode 8 is connected to the contact 胄 25 of the rotating basic sleeve 23 by the spiral lead 10. The branch is connected to the pantograph and is connected to the electric power of the radio frequency generator 40. The brush 29 remains in contact with the 25 contacts to supply radio frequency energy to the radio frequency electrode 8. The radio frequency electrode 8 is rotated to generate a more uniform radio frequency electric field around the radio frequency electrode 8. ίο 15 The reduction gear 35 reduces the input speed 'that is, the motor% output shaft The rotation speed of the rotating basic sleeve 23 is reduced to a lower output speed. The rotational force of the motor 38 is transmitted to the rotating basic sleeve 23 via the reduction gear 35 and the gear 26. The rotation of the rotating basic sleeve 23 is transmitted to the lead 10 After the rotation, the sleeve 21 is used to rotate the electrode wire 8a in the balloon 6. Therefore, the liquid filled in the inflatable balloon 6 is actuated by the electrode wires 6a to prevent irregular temperature distribution due to convection and The temperature of the liquid filled in the balloon 6 is equalized to the temperature of the liquid in the central region of the balloon 6, the temperature of the liquid near the wall portion of the balloon 6, and the temperature of the liquid in the vicinity of the wall of the balloon 6. The temperature of the tissue 18 in contact may be equal. Therefore, the temperature of the liquid 'measured by the thermocouple 12 and indicated by the thermometer 42 in the t-central region of the balloon 6 can accurately represent _ of the contact with the balloon 6 Temperature: 20 the The temperature of the body is measured when the radio frequency energy is supplied to the radio frequency electrode 8 by the thermocouple 12 disposed in the exposed section of the inner rod 3, and the output of the rhyme generator 40 is in a feedback control mode. It is controlled so that the liquid filled in the balloon 6 can be heated at the optimal temperature. Therefore, the tissue 18 in contact with the balloon 6 can be heated at the optimal temperature. The rotating basket-shaped RF electrode 8 generates a more uniform RF The electric field fills the liquid filled with the balloon 6. Therefore, the temperature distribution in the liquid 15 5 玖, the description of the invention can be uniform and the tissue 18 in contact with the balloon 6 can be precisely heated at the desired temperature and applied to the lungs The electrical isolation of the jk officer is used for the treatment of atrial fibrillation. 10 15 20 Figure 3 is used to explain the action of cauterizing the pores surrounding the pulmonary blood vessels 17 and the tissue 18 of the atrial 19. The physiological salt solution is supplied into the balloon 6 through the spoon and knife 51 and the physiological salt solution is sucked = the cycle outside the balloon 6 is repeated several times to purify the air of the balloon 6. As shown in the figure f4, the balloon 6 is compressed and the inner rod 3 is extended from the outer rod 2 so that the distance between the rotating sleeve 2G and the rotating sleeve ^ is increased to Limitation, and the electrode wire h of the radio frequency electrode 8 extends substantially linearly before the -Hai radio frequency hot air balloon catheter is inserted into the lung blood f 17. In this state, the diameter of the balloon 6 is reduced to a minimum. Missing 'The balloon 6 is inserted into the pulmonary blood vessel 17. The radio-frequency hot-air balloon guide 1 is operated to place the balloon 6 near the target tissues 18. Then, as shown at 4_, the inner rod 3 is withdrawn, and a contrast agent and a physiological salt solution are supplied into the balloon 6 through the branch tube 51 to inflate the balloon 6. Since the pre-rotation sleeve 20 is moved toward the post-rotation sleeve 2b, the electrode wires 8a are formed into an arc shape. Thereby, the radio frequency electrode $ is traced inside the balloon 6 in the shape of a blue sub. The radio-frequency hot-air balloon catheter i is continuously operated to bring the balloon 6 into contact with the target tissues 8. After that, the motor 38 is started to drive the rotating basic sleeve 23 for rotation by the reduction gear 35. The turning force of the turning basic sleeve 23 is transmitted to the turning back sleeve '16', invention description 21 by the spiral lead 10 extending through the catheter 4. Because J: Bu, |, / Λ / τ, the RF electrode 8 extending into the balloon 6 is dried to agitate the liquid filled in the balloon 6. The radio frequency = the radio frequency generator 40 applies a radio frequency current such as 13.5_ to the counter electrode 53 attached to the back of the patient, and the radio frequency electrode 25 of the continuous hot-air balloon catheter 1 extending in a basket shape. A radio frequency current flows through the brush 29 to contact the contact garment 25. Therefore, the balloon 6 and the groups in contact with the balloon 6 are heated by a capacitor type heating with radio frequency dielectric heating attached. The temperature in the upper region of the balloon 6 is only two. If the liquid contained in the balloon 6 is not good, it will be higher than the lower region of the balloon 6 due to convection. The temperature distribution of the liquid can be uniformed by agitating the liquid by the rotating RF electrode 8 extended in the shape of a basket. If the radio frequency is 15 °, ... the hole ball 6 is aligned and held in the balloon 6, the tissues 18 will be heated irregularly. Since the radio frequency electrode 8 is heated, a uniform radio frequency electric field can be generated around the radio frequency electrode 8, and the balloon 6 and the tissues 18 are uniformly heated by radio frequency heating. 20 亥 balloon 6 near the rotating sleeves 20 and 21, and the 4 knives for gathering the electrode wires have a tendency to overheat. Such overheating can be avoided by forming the rotating sleeves s 20 and 21 with a material having a small dielectric constant, such as Shuyue or ceramic materials, and / or by covering the electrode wires with resin to avoid them. And / or avoid it by circulating cooling water through the inner rod 3. Therefore, the lung ash tube 17 can be electrically isolated by cauterizing the tissue 18 entangled in the annular part of the pulmonary vascular plant, so that the patient can be safely treated for atrial fibrillation. 17 200416013 发明, description of the invention ο The radio-frequency hot-air balloon catheter 1 according to a second embodiment of the present invention is described in detail. The rear 4 radio-frequency hot-air balloon catheter i includes a circulatory system for studying in the balloon 6 Liquid to homogenize the liquid temperature distribution. -The portion of the inner rod 3 extending inside the balloon 6 is provided with a number of small nozzles 64. The cycle is not filled with 60 packs. A temperature controller 66 is used to keep a liquid being supplied / internally capable of 3, such as a 37 C liquid, and a liquid supply device 62. The liquid of a predetermined temperature controlled is supplied in the inner rod 3, and the liquid shot by the mouth through the small nozzles 64 can be sucked into the balloon 6 through the annular space between the inner rod: 2-the outer rod 2. When the balloon 6 is secret, the balloon 6 has a still spherical shape. A radio frequency electrode 8 is spirally wound around a portion of the inner rod 3 extending inside the balloon 6. The radio-frequency electrode 8 is connected to a radio-frequency generator 40 via a -lead 10. The temperature of the liquid contained in the balloon ㈣ is measured by a thermocouple 12 and is monitored in a similar manner to the above-mentioned fifteenth embodiment, and the radio frequency energy used to supply the radio frequency electrode 8 is measured according to the measurement To control the temperature. 20 As shown in FIG. 5, the temperature controller 66 is controlled at, for example, 37t-the circulating liquid 70 is at 44t㈣, and at the same time, the circulating liquid% flows through the portion of the inner rod 3 extending inside the balloon 6 and sprays. The small nozzles 64 flow into the balloon 6. The temperature of the circulating liquid 70 sprayed on the balloon slump dropped to 43.5t and when the circulating liquid 70 reached the front end of the outer rod 2, it was further advanced-to the point. Thereby, the circulating liquid% is circulated by the circulation system 60 times so that the liquid contained in the balloon 6 is kept at 43.5QC uniformly. The following detailed description is as the fifth money ball catheter 丄 18 200416013 玖, the description of the invention is applied to the drug treatment of the arterial application site, as shown in Figure 7. The balloon 6 of the radio-frequency hot-air balloon catheter 1 is contracted, and the radio-frequency hot-air balloon catheter! The femoral artery was inserted into the diseased site of the carotid artery 68, as shown in Fig. 6 (a). Then, a contrast agent and a physiological salt solution are supplied into the balloon 6 through a branch tube 51 attached to the outer rod 2. Therefore, 'the balloon 6 is inflated to stretch the narrow part of the diseased part 68, as shown in FIG. In this state, an i3 56MHz RF voltage is applied across the RF electrode 8 and the counter electrode 53 attached to the patient's back. 15 Lu The ring system 60 supplies, for example, 3η: of the circulating liquid 70 to the inner cavity of phase # 3. The circulating liquid μ heated by radio frequency is sprayed through the small nozzles 64 and sprayed into the balloon 6. The circulating liquid 70 flows through the balls 6 to make the temperature distribution inside the balloon 6 uniform, and is discharged through the inner cavity of the outer rod 2. When the balloon 6 is maintained at 43 5. 〇20 minutes or longer, the inflammatory cells or proliferative smooth muscle cells in the carotid artery atherosclerotic lesion site 68 will undergo apoptosis (―㈣, and the carotid artery atherosclerotic lesion site 68 Stable. After that, the balloon 6 is compressed and the radio-frequency hot-air balloon catheter i is withdrawn from the femoral artery. The radio-frequency hot-air balloon catheter i can uniformly heat the tissue of the diseased site 68 at an optimal temperature. Therefore, The atherosclerotic lesion 68 of the carotid artery can be stabilized via macrophages of these inflammatory cells or proliferating smooth muscle cells, that is, apoptotic apoptotic cells (apotasis), It is based on heating the carotid artery's atherosclerotic lesion site 68 at 43.5t for 20 minutes or longer without affecting normal tissues, such as the endothelium. This radiofrequency hot-air balloon catheter can be applied to cancerous hyperthermia 20 200416013 玖, invention description (hyperthermia). It turns out that cancer cells can be controlled or eradicated by heating them to 43.5. 20 minutes or more. As shown in FIG. 8 is a third embodiment of the present invention. Example radio frequency hot air balloon guide 1 'The radio frequency hot air balloon catheter 1 includes a balloon 6 and an actuating device 80 for agitating the liquid contained in the balloon 6 to make the temperature distribution of the liquid uniform. 10 15 The agitating device 80 includes a connecting tube 82 connected to an outer rod 2 for opening formation—an annular channel 83 defined by the outer rod 2 and—the inner rod 3 extends through Violation # 2, and a vibration generator, 81, for example, a vibration-producing diaphragm pump ⑽ vibrates to fill the liquid in the annular channel 83. The connection member 82 communicates with the balloon 6 through the annular channel 83. The vibration-generating benefit 81 is generated as A vibration force of about 1 Hz is spread through the liquid filling the connecting pipe 〃, the 4¼-shaped channel 83. Therefore, the / night body contained in the balloon 6 generates a vortex due to the interaction between the β-Hydraulic liquid and gravity. 85. The f vortex passes through this fluid in an indefinite direction _ the liquid, so that the temperature distribution of the 'night body' contained in the hole 6 can be uniformized. As a result, the pink tumors formed in these tissues 68 can be separated in one. The optimal temperature is heated homogeneously. "RF electrode 8 not shown in Figure 5 Similarly, the RF electrode 8 spirally wound around the inner rod is used for RF heating. 20 When the balloon 6 is a vibrating body generated by ShengZi 81, a moderate vortex is generated. When formed with a suitable flexible material, the vibration produces The power 86 enables the liquid crucible contained in the balloon 6 to be returned. ★ The radio frequency hot air balloon catheter of the government policy can heat the tissues in contact with the balloon by radio frequency 2 u soil temperature, and can; 20 200416013 发明 、 Explanation of the invention The full formation of a three-dimensional necrotic surface layer will not cause ulcers due to thrombosis or scorching of the tissue. Therefore, the treatment of arrhythmia can be safely and reliably achieved, such as isolation from the pulmonary vein and its pores through the pulmonary vein Atrial fibrillation triggered by extracardiac contractions. Since these tissues can be uniformly heated at an optimal temperature, the heating-arteriosclerosis portion is located at a temperature similar to that of inflammatory cells or proliferating smooth muscle cells within the factor 进行 to plan cells> Zhou Die (aPot It can stabilize the atherosclerosis without affecting normal tissues such as the endothelium. 10 15 Although the present invention has been described in detail with reference to certain preferred embodiments, it will be apparent that many modifications and changes can be made therein. For example, in the case of pure good implementation, the counter electrode is attached to the surface of the patient's body. The position of the m counter electrode 53 is not limited to the surface of the patient's body. The counter electrode 53 may also be provided on the wall of the balloon or inside the balloon, or the counter electrode 53 may also be provided adjacent to the balloon. It is known that the present invention can be implemented in a manner different from the specific description above without departing from it. Scope and spirit. [Brief Description of the Drawings] Figure 20-1 is a schematic perspective view of a front portion of a radio-frequency hot-air balloon catheter according to the first embodiment of the present invention; " " «Schematic perspective view of the front and back of the balloon catheter; Figure 3 is a schematic diagram illustrating the operation of the radiofrequency hot-air balloon catheter for the electrical isolation of pulmonary blood vessels for atrial fibrillation treatment. Figures 4 (a) and 4 (b) are schematic diagrams of a balloon catheter, respectively, when the balloon is compressed for insertion into a pulmonary vessel, and when the balloon is inflated to contact a target organ lesion 5; Figure 5 is a schematic perspective view of a radio-frequency hot-air balloon catheter according to a second embodiment of the present invention; Figures 6 (a) and 6 (b) are schematic diagrams of the radio-frequency hot-air balloon catheter shown in Figure 5 , Respectively, in a state where a balloon is compressed for insertion into the femoral artery, and when the balloon is inflated to contact a target tissue; 10 FIG. 7 illustrates a hot-air balloon catheter used to treat an artery Use of sclerosis ; And FIG. 8 is a view of a portion of the radiofrequency thermal balloon catheter of the third embodiment of the present invention. [Representative symbols for the main components of the figure] 1 ... radio frequency hot air balloon catheter 16 ... wire 2 ... outer rod 17 ... pulmonary blood vessel 3 ... inner rod 17 Note " -Mao dagger 4 ... catheter 18 ... target tissue 6 ... balloon 19 ... atrium 8 ... radio frequency electrode 20 ... rotation of front sleeve 8a ... electrode wire. 21 ... rotation of rear sleeve 10 ... lead 23 ... rotation of basic sleeve 12 ... thermocouple 24 ... ring body 14 ... stirring device 25 ... contact ring 22 200416013 发明, invention description 27,28 ... 0 ring 70 ... circulating liquid 29 ... brush 80 ... stirring device 31,33 ... external thread 81 ... vibration generator 32,34 ... nut 82 ... flange tube 35… reduction gear 83 " · ring channel 36,37 ... gear 85 ... vortex 38 ... motor 86 ... vibration force 40 ... radio frequency generator 42 ... thermometer 51 ... branch tube 53 ... counter electrode 60 ... circulation system 62 ... liquid supply device 64 ... nozzle 66 ... temperature controller 68 ... diseased area

23twenty three

Claims (1)

200416013 ίπ、申5靑專利範圍 1. 一種射頻式熱氣球導管,包括. 一導管,由一外桿及一内 二 門知所構成,該内桿延伸穿過 5亥外桿以可相對於該外桿滑動; 一膨脹氣球,可膨脹以邀— ^ ^ 目軚益官損害部相接觸且 設置於該外桿及該内桿的個別端部之間,· 一射頻電極,用以盥一 g + t μ 反电極結合作射頻能量供應, 延伸於该氣球之一壁部内或兮 一預定位置; ^虱球内部,該反電極設置於 一引線,電連接於該射頻電極; ίο ;及 % ’皿度感心’可感測容納於該氣球内的液體之溫度 體之溫度分布均勾化。 溫度分布均勻化裝置, 用以使容納於該氣球内的 2·如申請專利範圍第1 15 、 員所述之射頻式熱氣球導管,直中 該溫度分布均勻化裝置是一 ’、 氣球内的液體。 動办、、,内於该 3 ·如申請專利範圍第2 導管,進一 弟2項所述之射頻式熱氣球 步包括: 20 轉動前套管,放置於該 導管的軸心轉動; -轉動後套管’玫置於該外桿之一 内桿之-前端部上,以繞該 前端部上,以 繞該 導管的軸心轉動;及 軺動基本套官,持住該引線以致於可供&旦 於該引線且該引線可被轉動; %、頻能量 24 拾、申請專利範圍 其14射頻f極包含數電極線,以相互平行於該 轉動可套管與該轉動後套管之間,及 極、』Λ 1衣置包含一旋轉驅動裝置,用以驅動該射頻電 /轉動&套官、該轉動後套管、該引線及該轉動基本 备官以使其轉動。 =如申請專利範圍帛3項所述之射頻式熱氣球導管,其中 〜射頻電極包含數電極線以相互平行連接㈣轉動前套管 及該轉動後套管。 10 15200416013 Γπ, application 5 patent scope 1. A radio-frequency hot air balloon catheter, including. A catheter, which is composed of an outer rod and an inner two doors, the inner rod extends through the outer rod of 5 Hai so as to be opposite to the outer rod A rod slide; an inflatable balloon that can be inflated to invite — ^ 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 官 軚 軚 官 官 軚 軚 軚 軚 軚 官 軚 軚 軚 官 官 軚 軚 軚 官 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 軚 The damaged part of the officer contacts and is placed between the outer rod and the individual end of the inner rod, a radio frequency electrode for washing a g + t μ counter electrode cooperates with radio frequency energy supply and extends in one wall of the balloon or at a predetermined position; ^ inside the bulb, the counter electrode is disposed on a lead and is electrically connected to the radio frequency electrode; and% ' The dish degree sense can sense the temperature distribution of the temperature body of the liquid contained in the balloon. The temperature distribution uniformization device is used to make the radio frequency hot-air balloon catheter as described in the patent application scope No. 1 15 and the member, the temperature distribution uniformization device is a, inside the balloon. liquid. Operate ,,, within the 3 · If the patent application scope of the second catheter, the radio frequency hot air balloon step described in item 2 includes: 20 Turn the front sleeve, the axis of the catheter placed to rotate;-after the rotation The sleeve is placed on the front end of one of the outer rods to rotate around the front end to rotate around the axis of the catheter; and the basic sleeve is moved to hold the lead so that it can be used for & Once the lead wire and the lead wire can be rotated;%, frequency energy 24, patent application scope, 14 RF f poles including several electrode wires, parallel to each other between the rotating sleeve and the rotating sleeve The and pole, "Λ1" clothing includes a rotary drive device for driving the radio frequency / rotation & sleeve, the sleeve after the rotation, the lead and the basic preparation for rotation. = The radio-frequency hot-air balloon catheter according to item 3 of the application patent scope, wherein the radio-frequency electrode includes several electrode wires to be connected in parallel with each other. The front sleeve is rotated and the rear sleeve is rotated. 10 15 ^如申請專㈣圍帛4項所述之射頻式熱氣球導管,其中 形成該射頻電極之該等線性延伸電極線可被-曲成-圓狐 开:狀’以當該外桿及該内桿相互軸向移動以使該氣球膨脹 日丁可沿該氣球的一内表面延伸。 汝申明專利範圍第3項所述之射頻式熱氣球導管,其中 違引線螺旋盤繞,且該旋轉驅動裝置轉動該引線以轉動該 射頻電極。 7·如申請專利範圍第3項所述之射頻式熱氣球導管,其中 该旋轉驅動裝置驅動該轉動前套管、該轉動後套管、該引 線及該轉動基本套管以使其以相反方向交互轉動,且藉於 各該等相反方向預定的轉數,於轉動該轉動前套管、該轉 20 動後套管、該引線及該轉動基本套管之後改變該轉動前套 管、該轉動後套管、該引線及該轉動基本套管之轉動方向 8 ·如申5月專利範圍弟2項所述之射頻式熱氣球導管,其中 該攪動裝置包含: 25 200416013 拾、申請專利範圍 連接S ’連接於4外桿,藉—由該外桿與該内桿界 定之通道而與該氣球連通;及 辰動產生裝置’用以將震動力施予填滿於該連接管 及該通道之液體。 5 9·如巾請專利㈣第8項所述之射頻式純球導管,其中 *亥辰動產生裝置將震動力施予填滿於該連接管及該通道之 液體,以致於使容缺職球内之㈣巾產生旋渦。 10.如申請專利範圍第!項所述之射頻式熱氣球導管,其令 該溫度分布均勾化裝置是—循環裝置,用以循環容納於該 10氣球内的液體,以致於使容納於該氣球内的液體中溫度分 布均勻化。 11·如申請專利範圍帛H)項所述之射頻式熱氣球導管,其 中該内桿延伸於該氣球内之部位設置有數小噴嘴,及 該循環裝置包含-液體供應裝置,可供應該液體至該 15内桿内以經由該等小噴嘴噴射該液體且可經由該外桿及該 内桿所界定之該通道吸取噴射於該氣球内之液體。 12·如申請專利範圍第8項至第1〇項任一項所述之射頻式 …、氣球^管,其中該射頻電極是螺旋盤繞於該内桿於該氣 球内部之一部位。 20 u.如申請專利範圍第1項所述之射頻式熱氣球導管,其中 °玄氣球疋以抗血栓形成(antithrombogenic)的且熱阻性及換 性樹脂所形成。 14.如申請專利範圍第丨項所述之射頻式熱氣球導管,其中 忒預定位置是於病人身體的一位置,且該反電極是附著於 26 200416013 拾、申請專利範圍 病人身體上。 15.如申請專利範圍第1項所述之射頻式熱氣球導管,其中 該預定位置是於該氣球的一壁部内或該氣球内部之一位置 〇 5 16.如申請專利範圍第1項所述之射頻式熱氣球導管,其中 該預定位置是鄰近於該氣球之一位置。^ The radio-frequency hot-air balloon catheter as described in item 4 of the application, wherein the linearly extending electrode wires forming the radio-frequency electrode can be-curved into-round fox open: shaped as the outer rod and the inner The rods move axially relative to each other so that the balloon inflated daylight can extend along an inner surface of the balloon. The RF-type hot-air balloon catheter according to item 3 of the patent claim, wherein the lead wire is spirally wound, and the rotary driving device rotates the lead wire to rotate the RF electrode. 7. The radio-frequency hot-air balloon catheter according to item 3 of the scope of patent application, wherein the rotary driving device drives the pre-rotating sleeve, the post-rotating sleeve, the lead wire and the rotating basic sleeve to make them rotate in opposite directions. Alternately rotate, and change the pre-rotation sleeve, the rotation after rotating the pre-rotation sleeve, the 20-rotation sleeve, the lead, and the rotation basic sleeve after a predetermined number of revolutions in each of the opposite directions Rotation direction of the rear sleeve, the lead wire and the rotating basic sleeve 8 The radio-frequency hot-air balloon catheter as described in item 2 of the patent application in May, wherein the agitation device includes: 25 200416013 'Connected to 4 outer rods, which communicates with the balloon by means of a channel defined by the outer rod and the inner rod; and Chen movement generating device' for applying vibration force to the liquid filling the connecting tube and the channel . 5 9 · The radio-frequency pure ball catheter described in item 8 of the patent, in which the * Hychen motion generating device applies vibration force to the liquid filling the connecting tube and the channel, so that the capacity is absent. The towel inside the ball creates a vortex. 10. As the scope of patent application! The radio-frequency hot-air balloon catheter according to the item, the temperature distribution uniformization device is a circulation device for circulating the liquid contained in the 10 balloon, so that the temperature distribution in the liquid contained in the balloon is uniform. Into. 11. The radio-frequency hot-air balloon catheter according to item (H) of the patent application scope, wherein the inner rod extends into the balloon and is provided with several small nozzles, and the circulation device includes a liquid supply device for supplying liquid to Within the 15 inner rod, the liquid is sprayed through the small nozzles, and the liquid sprayed into the balloon can be sucked through the channel defined by the outer rod and the inner rod. 12. The radio frequency type ... balloon according to any one of the items 8 to 10 of the scope of application for a patent, wherein the radio frequency electrode is spirally coiled around the inner rod inside a part of the balloon. 20 u. The radio-frequency hot-air balloon catheter according to item 1 of the scope of the patent application, wherein the mysterious balloon is formed of an antithrombogenic and heat-resistant and transmutable resin. 14. The radio-frequency hot-air balloon catheter according to item 丨 of the scope of patent application, wherein the predetermined position is a position on the patient's body, and the counter electrode is attached to the body of the patient applying for patent scope. 15. The radio-frequency hot-air balloon catheter according to item 1 in the scope of patent application, wherein the predetermined position is a position in a wall portion of the balloon or inside the balloon. 05. According to item 1 in the scope of patent application The radio-frequency hot-air balloon catheter, wherein the predetermined position is a position adjacent to the balloon. 2727
TW92103941A 2001-09-28 2003-02-25 Radiofrequency thermal balloon catheter TW584552B (en)

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JP2001303112A JP3607231B2 (en) 2001-09-28 2001-09-28 High frequency heating balloon catheter

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DE102010032932A1 (en) * 2010-07-30 2012-02-02 Arne Briest Catheter used in cryosurgery, has expandable container portion with several bars in which a pair of electrodes or one electrode is arranged, and several spacers which are moved in catheter and electrically connected with electrodes
US10485609B2 (en) * 2016-10-18 2019-11-26 Acclarent, Inc. Dilation balloon with RF energy delivery feature

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