TWI320718B - Fluid pressure sensing chamber - Google Patents

Fluid pressure sensing chamber Download PDF

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TWI320718B
TWI320718B TW095139540A TW95139540A TWI320718B TW I320718 B TWI320718 B TW I320718B TW 095139540 A TW095139540 A TW 095139540A TW 95139540 A TW95139540 A TW 95139540A TW I320718 B TWI320718 B TW I320718B
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pressure sensing
extension
sensing chamber
cassette
chamber
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TW095139540A
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TW200724180A (en
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Raphael Gordon
Michael D Morgan
Gary P Sorensen
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Alcon Inc
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N31/00Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71Suction drainage systems
    • A61M1/73Suction drainage systems comprising sensors or indicators for physical values
    • A61M1/732Visual indicating means for vacuum pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71Suction drainage systems
    • A61M1/72Cassettes forming partially or totally the fluid circuit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71Suction drainage systems
    • A61M1/77Suction-irrigation systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0201Cassettes therefor
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • A61F9/00736Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
    • A61F9/00745Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments using mechanical vibrations, e.g. ultrasonic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/12General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Pulmonology (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • External Artificial Organs (AREA)
  • Measuring Fluid Pressure (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Switches Operated By Changes In Physical Conditions (AREA)

Description

1320718 九、發明說明: I:發明所肩^^技術部域3 發明領域 本發明係概括有關液壓感測腔室且更特別有關使用於 5 眼科手術設備中之液壓感測腔室。 I:先前技術3 發明背景 當年齡或疾病造成水晶體變成較不透明時,因為可被 透射至網膜的光線減少而使視力惡化。眼睛水晶體的此缺 ίο 陷在醫學上稱為白内障。此狀況之一種被接受的治療方式 係為手術移除水晶體且用一人工眼内水晶體(IC)L)來取代 水晶體功能。 在美國’大部份白内障水晶體係由一稱為超音波水晶 體乳化術(phacoemulsificaiton)之手術技術予以移除。此程 15序期間,將一細的超音波水晶體乳化術切割梢插入有病水 晶體内且超音波地振動。振動的切割梢係液化或乳化水晶 體使得水晶體可被吸出眼睛外。有病的水晶體一旦被移除 則用一人工水晶體來取代。 適合眼科程序之一典型超音波手術裝置係由一被超音 20波式驅動的手持件、一經附接的切割梢、及灌注套筒及一 電子控制面板所組成。手持件總成係被一電線纜及撓性管 件組裝至控制面板。經由電線纜,面板改變手持件傳輸至 經附接切割梢之功率位準,而撓性管件經由手持件總成將 灌注流體供應眼睛至且自眼睛抽取吸出流體。 5 手持件的操作部分係為被直接地附接至一組壓電結晶 之一設置於中央、中空的共振板或喇叭。結晶係供應超音 波水晶體乳化術期間驅動味j I»八及經附接切割梢兩者所需要 之超音波振動並被面板所控制。結晶/剩叭總成係被撓性安 襞件懸設於手持件的中空體部或殼套内。手持件體部係終 止於體部的遠端處之一降低直徑部或頭錐中。頭錐係具有 外螺紋以接受灌注套筒。同理,喇叭孔徑係在其遠端處具 有内螺紋以接收切割梢的外螺紋。灌注套筒亦具有一内螺 紋式孔徑而其螺接在頭錐的外螺紋上。切割梢係被調整使 得梢只以一預定量突起超過灌注套筒的開放端。 使用中,灌注套筒及切割梢的端點係被插入角膜、鞏 膜或其他部位之-具預定寬度的小切口内,割梢係在灌 注套筒内受到被結晶義式超音L沿其縱鱗作超音 波振動,藉以在現場乳化經選定的組織。切割梢的中空孔 徑係與外Λ巾之隸呈導通,後者轉而與從手持件至=板 之吸出線呈導通。面板中之-通常身騎動料降低壓力 或真空源係自眼睛抽取或吸出經乳化組織經由切割梢的開 放端、切割梢及喇叭孔徑及吸出線而進入—收集裝置中。 藉由-經過灌注套筒的内側表面與切割梢之間的^環狀間 隙被注入手術位㈣之鹽树•料私劑來辅助經乳 化組織的吸出。 先前技藝裝置已經使用用以偵剩灌注壓力或吸出真空 之感測器。以來自這些感測器的眘 ' — 貝讯為基礎,手術面板係 可被程式化作回應藉以使得手術程序更加有,二 1320718 為了降低被所吸出流體污染之風險,近來的手術系統係使 用關閉式壓力感測器,其中流體不會接觸到用來感測液壓 之感測元件或其他裝置。一此壓力感測器係顯示於美國專 利案5,392,653號(贊格(Zanger)等人)中。然而,此等關閉式 5 壓力感測器的整體效能係大部分地依據自系統清除所有空 氣之作用而定。空氣遠比手術所使用的灌注流體更可壓 縮,且空氣囊袋或氣泡對於系統增加了順應性。順應性導 致不良的壓力變異及起伏。自經密封液體系統清除空氣(或 “備妥(priming)’’系統)之常見方法係包括避免系統内的尖_銳 10 邊緣及驟然形狀變化及自系統底部或低點以液體來充填系 統。這可隨著自下方以液體來充填系統而讓空氣逃出系統 頂部。本發明的發明人已經發現,關閉式手術流體系統内 所出現之一壓力感測腔室的初始備妥係相對較容易,但如 果允許空氣氣泡進入腔室(譬如,如果在程序中間更換手術 15 手持件),這些空氣氣泡極難以自系統清除。此困難係為空 氣氣泡的表面張力(而非系統初始備妥所包含之未包封空 氣)造成氣泡相對較為強固且一旦被導入則不易破壞抽出 壓力感測腔室外之結果。此外,圍繞於空氣氣泡之液體“膜” 係具黏性,造成氣泡黏結或黏著至系統内的表面並抵抗進 20 一步運動,即便有很高流率亦然。一參考文件美國專利案 6,059,765號(柯爾(Cole)等人)已經建議,特定的腔室形狀及 出口部位可輔助從手術系統移除空氣。發明人已經發現此 參考文件所討論的腔室形狀及設計並不足以確保空氣氣泡 自系統被清除。 7 1320718 為此,仍需要一可防止空氣進入腔室且被困陷於腔室 内之壓力感測腔室。 【發明内容;1 發明概要 5 本發明係藉由提供一具有延伸經過腔室之包含一降低 直徑部的管件延伸部之壓力感測腔室來改良先前技藝蠕動 泵。管件係含有複數個埠藉以容許自腔室清除空氣,但埠 的尺寸可使進入管件的氣泡無法容易地流入腔室内。降低 直徑部係在孔之間生成一壓力差。此差壓係在高液體流及 10 紊擾液體流事件下生成經過腔室之流。 本發明之一目的係對於一卡匣提供一容易備妥之壓力 感測腔室。 本發明之另一目的係提供一不准空氣氣泡變成困陷在 腔室中之壓力感測腔室。 15 本發明之另一目的係提供一具有一延伸經過腔室的管 件延伸部之壓力感測腔室。 將從詳細描述、圖式及申請專利她圍得知本發明之 些及其他優點與目的。 圖式簡單說明 20 第1圖為可配合使用本發明之一手術系統的立體圖; 第2圖為可配合使用本發明之一外科卡匣的立體圖; 第3圖為本發明的壓力感測腔室之第一實施例的放大 立體圖; 第4圖為本發明的壓力感測腔室之第二實施例的放大 8 立體圖。 t貧施方式】 較佳實施例之詳細說明 如第1圖清楚地顯示’市售手術系統—般係包括手術面 板ilo ’其附接有可調整式梅約(mayo)托板10及藉由吸出管 件22附接至面板110之手持件2G,灌注管件24及電源線镜 26 °通往手持件20的電源以及吸出流體與灌注流體的流動 係由面板110所控制,面板11〇含有皆為此技藝熟知之諸如 電源供應器、泵、壓力感測器、閥等適當硬體及軟體。如 1〇第2圖清楚地顯示’可配合使用本發明之卡匣200係接收吸 出笞件22及灌/主管件且裝設在面板11 〇的卡匣接受部25 内。卡匣200含有一壓力感測腔室21〇,壓力感測腔室21〇係 可由在卡匣200的體部220内形成且被壓力感測隔膜215包 圍之中空空隙230所組成。卡匣200可為任何多種市售手術 15 卡匣,諸如得自德州沃司堡的歐康研究室公司(Alcon
Laboratories,Inc.)的INFINITI®流體管理系統。體部22〇 — 般係由一適當熱塑性塑料所模製。 如第3圖清楚地顯示,腔室210含有延伸經過空隙230之 管件延伸部240,基本上將空隙230平分成兩個相等半球, 20 但亦可使用來自腔室210及空隙230之其他形狀。管件延伸 部可被一體成髮至體部220内,或者可與吸出管件22—體成 型。任一案例中,管件延伸部240係與吸出管件22流體式導 通藉以將流體抽過吸出管件22且進入蠕動泵250中,如第3 圖的流箭頭所示。一或多個孔260係穿透經過管件延伸部 9 24〇藉以讓流體導通於吸出管線22、空隙230及隔膜215之 間。此等流體導通係可讓吸出管件22内的壓力變化被導通 至空隙230,造成隔膜215中的撓曲而其可由一安裝在面板 110的卡匣接收部25内之感測元件(未圖示)所感測。孔260 可在卡匣200的初始備妥期間讓空隙230被清除空氣。更重 要的是,孔260的尺寸及形狀係使得進入吸出管線22之任何 空氣氣泡無法容易地流過孔260且進入空隙230。孔260的位 置及尺寸係促進管件延伸部240内之良好的氣泡留置但在 空隙230的初始液體充填期間仍可讓流體流過孔260。 如第4圖清楚地顯示’為了促進空隙230’的初始充填, 管件延伸部240’的内部尺寸可具有一降低直徑部241藉以 在管件延伸部240,内生成一流限制。該流限制係在限制器 242下方經過孔260’之空隙230’的初始液體充填期間促進液 體流。管件延伸部240’内的流限制器242亦在限制器242上 方的孔260”與限制器242下方的孔260,之間生成一壓力 差。此差壓係在高液體流及紊擾液體流事件下生成經過空 隙230’之流。範例中,孔260、260,及260”係為位於0.0002 平方吋至0.02平方吋的級數之面積。孔260 ' 260’及260”的 此等精密尺寸係防止空氣氣泡及經吸出組織因為氣泡的表 面張力而穿過孔260、260’及260”。圍繞懸浮於一液體中的 空氣泡之液體膜係極強韌且很能抵抗穿刺或破裂。因此, 孔260、260’及260”的小尺寸係防止任何空氣氣泡穿過孔 260、260’及260”。此外,使用期間,通常因為泵25〇的操 作而在吸出管線22及22 ’及管件延伸部240及240,中抽取一 1320718
真空(負壓力)。由於此真空之緣故’毫無或極少液體逃出管 件延伸部外且進入空隙230及230’内。因此,幾乎沒有流體 流入空隙230及230’藉以將任何空氣氣泡攜入空隙mo及 230,内。 此描述係僅供示範及說明。熟習相關技術者瞭解可對 於所描述的本發明作出修改而不脫離其範圍或精神。 C圓式簡單說明3
第1圖為可配合使用本發明之一手術系統的立體圖; 第2圖為可配合使用本發明之一外科卡匣的立體圖·’ 1〇 第3圖為本發明的壓力感測腔室之第一實施例的放 立體圖; 第4圖為本發明的壓力感測腔室之第二實施例的放大 立體圖。 【主要元件符號說明】
10…可調整式梅約(mayo)托板 215…壓力感測隔膜 20…手持件 220…體部 22,22’…吸出管件 230,230’…空隙 24…灌注管件 240,240’…管件延伸部 25…卡匣接受部 241…降低直徑部 26…電源線纜 242…流限制器 110···手術面板 250…蠕動泵 200…卡匣 …孔 210…壓力感測腔室 11

Claims (1)

1320718 修正9期:98年11月30曰 十、申請專利範圍: 1·—種卡匣,包含: a) —體部; 5
10 b) 一壓力感測腔室,其形成於該體部中;及 h 0-管件延伸部’其延伸經過力制腔室該 s件L伸。P具有-降低直;^部以及與該屢力感測腔室 呈流體導通之至少一孔。 2.如申請專利範㈣1項之卡厘,其中該>1力感測腔室係 包含一被一壓力感測隔膜所包圍之形成於該體部中之 中空空隙。 3·如申請專利範圍第i項之卡E,其中該卡_ —步包含 一螺動系’該管件延伸部係與朗祕呈流體導通。 4. 如申請專·㈣丨項之切,其巾料孔係為近似 0.0002平方吋至〇〇2平方吋之間的面積。 5. 如申請專利範圍第i項之切,其中該管件延伸部係一 體成型在該體部中。 6·如申請專利範圍第i項之卡E,進—步包含_連接至該 卡ϋ之吸出管件而該管件延伸部形成為該吸出管件的 一部分。 •如申請專利範圍第3項之#,進一步包含—連接至該 卡S且與該場動泵呈流體導通之吸出管件而該管件延 伸部形成為該吸出管件的一部分。 •如申請專利_第丨項之切,其中料孔的尺寸及形 狀係使得進入該管件延伸部的任何空氣氣泡不會進入 r 12 1320718 該壓力感測腔室。 9. 一種卡匣,包含: a) —體部; b) —壓力感測腔室,其形成於該體部中,該壓力感 5 測腔室係形成為被一壓力感測隔膜所包圍之該體部中 之一中空空隙;及 c) 一管件延伸部,其一體成型於該體部中且延伸經 過該壓力感測腔室,該管件延伸部具有一降低直徑部以 及與該壓力感測腔室呈流體導通之複數個孔。 10 15 20 10. 如申請專利範圍第9項之卡匣,其中該卡匣進一步包含 一蠕動泵,該管件延伸部係與該蠕動泵呈流體導通。 11. 如申請專利範圍第9項之卡匣,其中該等孔係為近似 0.0002平方吋至0·02平方吋之間的面積。 12. 如申請專利範圍第9項之卡匣,進一步包含一連接至該 卡匣之吸出管件。 13. 如申請專利範圍第10項之卡匣,進一步包含一連接至該 卡匣且與該蠕動泵呈流體導通之吸出管件。 14. 如申請專利範圍第9項之卡匣,其中該等孔的尺寸及形 狀係使得進入該管件延伸部的任何空氣氣泡不會進入 該壓力感測腔室。 15. —種手術系統,包含·· a) —手術面板,其具有--^匣接收部; b) —手術卡匣,其被該面板接收於該卡匣接收部 中,該卡匣具有: 13 νυ/18 5
15
20 —i)一體部; •-ii)一壓力感測腔室,其形成於該體部中;及 —iii)一管件延伸部,其延伸經過該壓力感測腔室, 該管件延伸部係具有一降低直徑部以及與該壓力 感測腔室呈流體導通之複數個孔。 16. 如申請專利範圍第15項之手術系統,其中該壓力感測腔 室包含被一壓力感測隔膜所包圍之形成於該體部中之 一中空空隙。 17. 如申請專利範圍第15項之手術系統’其中該卡匣進一步 包含一蠕動泵,該管件延伸部係與該蠕動泵呈流體導 通。 •如申β月專利範圍第15項之手術系統’其中該等孔係為近 似0.0002平方吋至〇.〇2平方吋之間的面積。 19·如申請專利範圍第15項之手術系統,其中該管件延伸部 係一體成型在該體部中。 20·如申請專利範圍第15項之手術系統,進一步包含—連接 至該卡匣之吸出管件而該管件延伸部形成為該吸出管 件的一部分。 21·如申請專利範圍第17項之手術系統,進一步包含—連接 至該卡匣且與該蠕動泵呈流體導通之吸出管件而該管 件延伸部形成為該吸出管件的一部分。 22.如申請專利範圍第15項之手術系統,其中該等孔的尺寸 及形狀係使得進入該管件延伸部的任何空氣氣泡不會 進入該壓力感測腔室。 14
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