TWI389669B - 拋棄式病患介面裝置 - Google Patents
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- A—HUMAN NECESSITIES
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- A61F—FILTERS 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
- A61F9/00—Methods 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
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- A—HUMAN NECESSITIES
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- A61F—FILTERS 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
- A61F9/00—Methods 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
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Description
本發明之技術領域為供眼科手術雷射系統使用之病患介面裝置。
最近幾年,眼科手術領域已取得許多進展。具體而言,雷射正越來越頻繁地用於實施某些眼科外科手術。此等手術之一重要方面係相對于雷射系統準確定位眼睛,從而容許以高精確度導引雷射光束。眼科外科手術期間導引雷射系統之精確度很重要,此乃因不準確地或不適當地導引雷射光束會對眼睛造成永久損傷。
一種相對于雷射光束定位眼睛之方法係使用一接觸鏡片來穩定眼睛。然而,此方法需要接觸鏡片本身準確對準雷射源,且因此不能令人滿意地解決對準問題。
另一用於維持眼睛與雷射源間對準之方案係將透鏡永久安裝在雷射系統之射出光瞳上。然而,在接觸鏡片永久安裝在雷射系統上之情況下,需要在每一外科手術後對該等透鏡加以消毒。或者,可在每一手術後更換透鏡,但此一方案需要在系統可使用前對每一更換之接觸鏡片對準射出光瞳。在任一情況下,會給每一手術增添額外的時間及成本。
提供準確對準之替代方法亦已為吾人所熟知。頒予Lai之美國專利第5,549,632號描述一用於控制眼科手術期間角膜形狀之裝置,該案之揭示內容以引用的方式併入本文中。將一透明平板放置成與一病患眼睛角膜接觸。平板產生一固定參考定位框架,雷射光束控制系統可使用其來定位雷射光束之焦點。將具有撓性連接點之活節臂遠端處之手術器具頂端放置成與平板接觸,追隨病患眼睛之任何運動,並使雷射光束對準手術器具頂端。平板亦提供一控制病患眼睛角膜上皮與空氣間折射邊界折射率曲線之手段。
供眼科雷射系統使用之各種類型拋棄式接觸鏡片亦已為吾人所熟知。舉例而言,頒予Juhasz等人之美國專利第6,254,595號描述一于眼科雷射手術期間使用之拋棄式扁平透鏡,該案之揭示內容以引用的方式併入本文中。該拋棄式扁平透鏡包括一具有實質上平行於一平坦扁平表面之平坦前表面之透鏡。一裙部圍繞該扁平表面並由此向外延伸以界定一室。另外,裙部包括一環繞該扁平表面形成之真空溝道。手術期間,裙部與角膜間之接觸封閉真空溝道。一真空幫浦與封閉的真空溝道間保持液體連通,並在外科手術期間使用以至少部分抽空該真空溝道,從而緊貼著角膜密封裙部。
頒予Juhasz等人美國專利第6,373,571號描述一拋棄式接觸鏡片及一用於在雷射系統上安裝接觸鏡片之可調節扣環,該案之揭示內容以引用的方式併入本文中。為使拋棄式接觸鏡片正確對準雷射系統,使接觸鏡片上之參考標記沿雷射光束路徑與預定焦點重合。
本發明係關於在雷射眼科手術期間穩定眼睛並在眼睛與眼科手術雷射系統間提供一介面之病患介面裝置。該病患介面裝置之框架具有一扁平端及一附著端。該附著端適合與該手術雷射系統偶接。一裙部固定於該框架之扁平端上且適合緊貼著角膜前表面密封以形成一室。一透鏡靠近該框架扁平端佈置且藉由一撓性支架固定於該框架上。
視情況,該病患介面裝置可構造成一生物屏障。該撓性支架可為環形且經構造以於眼睛與該眼科手術雷射系統間起生物屏障作用。對於此一構造,該框架可由多孔側壁構成以形成空腔。框架附著端亦適合緊貼著眼科手術雷射系統密封以提供另外的生物屏障。框架之另一端即扁平端可包括一或多個排氣孔。此等排氣孔有助於消除角膜及撓性生物屏障以及透鏡間所捕獲空氣或流體之相對壓力變化。
因此,本發明提供一種用於眼科手術雷射系統的改良病患介面裝置。其他目的及優點將於下文中呈現。
詳細地參照附圖,附圖1圖解說明一適合於介於眼科手術雷射系統(未圖示)與眼睛角膜(未圖示)間之病患介面裝置11。病患介面裝置11之框架13具有一附著端15及一扁平端17。該附著端15係寬闊且開放的以容納眼科手術雷射系統之射出光瞳,而扁平端17明顯較窄以便於外科手術期間裝置11與眼睛間之偶接。在附著端15與扁平端17之間,框架13之側壁19形成一錐形腔。然而,框架13之形狀通常係一設計選擇問題。框架13亦具有非多孔側壁19。側壁19中缺少孔有助於降低外科手術期間眼睛與眼科手術雷射系統間交叉感染之機會。然而,若能定位側壁孔以於眼睛與眼科手術雷射系統之間保持無菌屏障,則一更為開放的框架會較合適。
一環形裙部21、一環形撓性支架23及一透鏡25固定於框架13之扁平端17上,其中裙部21及撓性支架23直接固定於框架13上,且透鏡25直接固定於撓性支架23上。框架13扁平端17之詳細情況於圖2中闡明。環形裙部21安裝於框架13之扁平端17中之補合環形溝道27中。溝道27包括一側開孔29,臂31自裙部21延伸穿過該開孔。臂31容納有一通道33,其可穿過一管37固定於一真空幫浦35上。真空幫浦35可係一注射器或任何其他能產生負壓之機械裝置。病患介面裝置11可在手術期間用於固定眼睛。出於此目的,裙部21較佳由一柔軟可彎材料構成。當裙部21緊貼眼睛39放置時,形成一室41且可使用真空幫浦35在該室內產生至少一部分真空,藉此使裙部21(及因而使病患介面裝置11)偶接至眼睛39上。
較佳使用一適合於所用材料之黏合劑將裙部21固定於框架13之扁平端17上。此一黏合劑應為當曝露於來自通常於眼科手術雷射系統中採用之雷射器之光下時不會很快變質之黏合劑。
透鏡25具有一後表面43及一前表面45,且其可係平的(如所展示)或該等表面之一或二者皆係彎曲的。前表面45之外邊緣附著於撓性支架23上。再次,黏合劑可係任何適合於所用材料者,其中需考慮到黏合劑將曝露于其中之雷射光。正如在相關技藝中所瞭解,透鏡25之前表面45在外科手術期間與角膜接觸,且弄平、構造或以其他方式塑造角膜之形狀來實施外科手術。因而,透鏡25之幾何構造端視外科手術期間角膜擬依據之形狀而定。透鏡25較佳由便宜且強度高的透明材料(例如玻璃、塑料或諸如此類)製成。
撓性支架23本身可使用一黏合劑附著於框架13之扁平端17上,但亦可使用機械偶接。對於黏合劑之考慮因素同樣如此。
于眼科雷射手術期間,當病患介面裝置11偶接至眼睛39時,產生一第二室49。該第二室49係藉由透鏡25之前表面45、撓性支架23、框架13之環形溝道27、環形裙部21及眼睛39之角膜形成。第二室49之體積隨透鏡25在撓性支架上之移動而變化。透鏡移動量係一決定弄平、構造或以其他方式塑造成形來實施外科手術之角膜量之重要因數。當第二室49之體積改變時,空腔內出現局部壓力變化。此壓力變化對使用透鏡25按照需要塑造角膜形狀之能力產生不利影響。為緩解此問題,於框架13之扁平端17內佈置排氣孔51。排氣孔51容許第二室49內空氣或流體之相對壓力等於大氣壓力。排氣孔51較佳既不損害眼睛39與眼科手術雷射系統間之無菌屏障,也不損害真空室41內已確定的壓力。病患介面裝置11可僅包括一個排氣孔,或包括多達十二個或更多個排氣孔。多個排氣孔較佳於環繞一垂直於透鏡25之軸之環中有規律地間隔佈置。排氣孔51有助於確保角膜形狀僅由透鏡25之後表面43上之壓力決定。
圖3圖解說明病患介面裝置11,其在病患眼睛39與眼科手術雷射系統之射出光瞳外殼47間提供一介面。病患介面裝置11之框架13經構造以具有一補合於射出光瞳外殼47之形狀。此容許射出光瞳外殼47直接插入框架13中並緊鄰眼睛39放置但不與眼睛39有物理接觸,藉此便於實施外科手術同時降低眼睛與射出光瞳外殼47間交叉感染之機會。
框架13之附著端15偶接至射出光瞳外殼47上以進一步降低交叉感染之機會並穩定介面。此偶接可藉由在環繞框架13之附著端15之環49中納入一鐵磁材料及於射出光瞳外殼47中納入補合的滑動電磁鐵53而達成。電磁鐵51在徑向方向上可滑動,以便當受到激活時,其可與框架13之附著端15偶接並緊貼著框架13之附著端15密封。亦可採用偶接框架13與射出光瞳外殼47之替代方法,包括一或多個機械閂鎖、可充氣的囊及諸如此類。
由此,本發明揭示一種供眼科手術雷射系統使用之改良病患介面裝置。儘管已顯示並描述了本發明之實施例,但是熟習此項技術者應理解,可進行更多的修改,此並不背離本發明的概念。因此,本發明僅受隨附申請專利範圍之精神的限制。
11...病患介面裝置
13...框架
15...框架之附著端
17...框架之扁平端
19...框架之側壁
21...環形裙部
23...環形撓性支架
25...透鏡
27...環形溝道
31...臂
33...通道
35...真空幫浦
37...管
39...眼睛
43...透鏡之後表面
45...透鏡之前表面
47...射出光瞳外殼
49...第二室
51...排氣孔
在該等附圖中,其中類似的參考數字係指類似的組件:圖1係病患介面裝置之分解透視圖;圖2係病患介面裝置之扁平端之橫截面局部放大圖;以及附圖3係採用的介於眼科手術雷射系統與眼睛間之間的病患介面裝置之橫截面圖。
13...框架
15...框架之附著端
17...框架之扁平端
19...框架之側壁
21...環形裙部
23...環形撓性支架
25...透鏡
Claims (20)
- 一種適合在角膜與手術雷射系統間提供一介面之病患介面裝置,該裝置包括:一具有一扁平端及一附著端之框架,其中該附著端適合偶接至該手術雷射系統上;一固定至該框架扁平端上之裙部,其中該裙部適合緊貼著該角膜之前表面密封以形成一室;一靠近該框架扁平端佈置之透鏡;以及一將該透鏡固定至該框架上之撓性支架。
- 如請求項1之裝置,其中該附著端包含非多孔側壁。
- 如請求項2之裝置,其中該等側壁形成一錐形腔。
- 如請求項1之裝置,其中該框架之扁平端包括一排氣孔。
- 如請求項1之裝置,其中該撓性支架包括一生物屏障。
- 如請求項1之裝置,其中該撓性支架呈環形。
- 如請求項6之裝置,其中該透鏡位於該環形撓性支架中央。
- 如請求項1之裝置,其中該附著端適合緊貼著該手術雷射系統密封。
- 如請求項1之裝置,其中該附著端包括一鐵磁材料。
- 如請求項1之裝置,其進一步包括一與該室流體連通之真空幫浦。
- 如請求項1之裝置,其中該裙部呈環形。
- 一種適合在角膜與手術雷射系統間提供一介面之病患介 面裝置,該裝置包括:一具有一扁平端及一附著端之框架,其中該附著端包含非多孔側壁且該附著端適合偶接至該手術雷射系統並緊貼著該手術雷射系統密封,且其中該扁平端包含一排氣孔;一固定至該框架扁平端上之裙部,其中該裙部適合緊貼著該角膜之前表面密封以形成一室,而該排氣孔並未與該室流體連通;一靠近該框架之扁平端佈置之透鏡;以及一將該透鏡固定至該框架上之撓性生物屏障。
- 如請求項12之裝置,其中該側壁形成一錐形腔。
- 如請求項12之裝置,其中該生物屏障呈環形。
- 如請求項14之裝置,其中該透鏡位於該環形生物屏障的中央。
- 如請求項12之裝置,其中該附著端包括一鐵磁材料。
- 如請求項12之裝置,其進一步包括一與該室流體連通之真空幫浦。
- 如請求項12之裝置,其中該裙部呈環形。
- 一種適合在角膜與手術雷射系統間提供一介面之病患介面裝置,該裝置包括:一具有一扁平端及一附著端之框架,該附著端適合偶接至該手術雷射系統上並緊貼著該手術雷射系統密封,且該扁平端包括至少一個排氣孔;一固定至該框架之扁平端上之環形裙部,其中該裙部 適合緊貼著該角膜之前表面密封以形成一第一室;一靠近該框架之扁平端佈置之透鏡;一將該透鏡固定至該框架上之環形撓性生物屏障,其中該透鏡位於該生物屏障的中央;以及一與該第一室流體連通之真空幫浦;其中該透鏡、該生物屏障、該角膜之前表面、該扁平端及該裙部係形成一與至少一排氣孔流體連通之第二室,該第二室具有一體積,該體積係隨該透鏡在該生物屏障上移開而變化。
- 如請求項19之裝置,其中該附著端包括一鐵磁材料。
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US11/258,399 US7611507B2 (en) | 2005-10-24 | 2005-10-24 | Disposable patient interface |
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TW200730128A TW200730128A (en) | 2007-08-16 |
TWI389669B true TWI389669B (zh) | 2013-03-21 |
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TW095139079A TWI389669B (zh) | 2005-10-24 | 2006-10-23 | 拋棄式病患介面裝置 |
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US (1) | US7611507B2 (zh) |
EP (1) | EP1940307B1 (zh) |
AU (1) | AU2006306332B2 (zh) |
CA (1) | CA2627291C (zh) |
TW (1) | TWI389669B (zh) |
WO (1) | WO2007050572A2 (zh) |
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WO2007050572A2 (en) | 2007-05-03 |
US7611507B2 (en) | 2009-11-03 |
EP1940307A2 (en) | 2008-07-09 |
AU2006306332A1 (en) | 2007-05-03 |
CA2627291A1 (en) | 2007-05-03 |
CA2627291C (en) | 2015-08-11 |
US20070093796A1 (en) | 2007-04-26 |
AU2006306332B2 (en) | 2012-03-08 |
EP1940307B1 (en) | 2014-05-07 |
TW200730128A (en) | 2007-08-16 |
WO2007050572A3 (en) | 2007-11-22 |
EP1940307A4 (en) | 2011-03-23 |
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