本案主張於2020年1月3日提交的美國專利申請第62/956,731號的優先權，其全部揭示藉由引用併入本文。This application claims priority to U.S. Patent Application No. 62/956,731, filed on January 3, 2020, the entire disclosure of which is incorporated herein by reference.
本發明係關於用於治療包括動物、哺乳動物、及人類眼睛的眼睛的結構的系統及方法。更特定言之，本發明的實施例係關於用於解決眼睛狀況的包括超音波的音波能量與包括雷射的光能量的組合使用的系統及方法。The present invention relates to systems and methods for treating ocular structures, including animal, mammal, and human eyes. More particularly, embodiments of the present invention relate to systems and methods for treating ocular conditions using a combination of acoustic energy, including ultrasound, and light energy, including lasers.
在第11圖中一般展示自然人類眼睛的解剖結構，第11圖係為眼睛的橫截面圖。鞏膜131是圍繞除了在角膜101處之外的水晶體103的白色組織。角膜101是包含眼睛的外部表面的透明組織，光首先藉由外部表面而進入眼睛。虹膜102是有色的可收縮的膜，而藉由改變在其中心（瞳孔）的圓形光圈的大小來控制進入眼睛的光量。眼睛或自然晶狀水晶體103（更詳細的圖片展示在第11A圖中（針對類似結構使用類似元件符號））係位於虹膜102之後。術語眼睛水晶體、自然晶狀水晶體、自然水晶體、自然人類晶狀水晶體、及水晶體（當指先前術語時）在本文中可以互換使用，並且指稱人類眼睛的相同解剖結構。The anatomy of a natural human eye is generally illustrated in Figure 11, which is a cross-sectional view of the eye. The sclera 131 is the white tissue surrounding the lens 103, excluding the cornea 101. The cornea 101 is the transparent tissue that comprises the outer surface of the eye, through which light first enters the eye. The iris 102 is a colored, flexible membrane that controls the amount of light entering the eye by varying the size of the circular aperture at its center (the pupil). The lens 103 (shown in more detail in Figure 11A (similar reference numbers are used for similar structures)) is located behind the iris 102. The terms lens of the eye, natural crystalline lens, natural crystalline lens, natural human crystalline lens, and crystalline body (when referring to the previous terms) are used interchangeably herein and refer to the same anatomical structure of the human eye.
通常，眼睛水晶體透過睫狀肌108的作用而改變形狀，以允許視覺圖像的聚焦。來自大腦的神經反饋機制允許睫狀肌108藉由韌帶111的附接而起作用，以改變眼睛水晶體的形狀。通常，當光藉由角膜101及瞳孔進入眼睛，然後沿著視軸104行進通過眼睛水晶體103並通過玻璃體110而到達眼睛的後方的視網膜105，在黃斑106處形成圖像，而藉由視神經107轉移到大腦時，就會發生視力。角膜101與視網膜105之間的空間被前房109中的稱為水117以及水晶體的後房中的稱為玻璃體110（凝膠狀的透明物質）的液體所填充。Normally, the lens of the eye changes shape through the action of the ciliary muscle 108 to allow visual images to be focused. A neural feedback mechanism from the brain allows the ciliary muscle 108, attached via ligaments 111, to function and change the shape of the lens. Normally, vision occurs when light enters the eye through the cornea 101 and pupil, travels along the visual axis 104 through the lens 103, and through the vitreous humor 110 to the retina 105 at the back of the eye, where it forms an image at the macula 106. This image is then transferred to the brain via the optic nerve 107. The space between the cornea 101 and the retina 105 is filled with a fluid called aqueous 117 in the anterior chamber 109 and a gel-like, transparent substance called vitreous humor 110 in the posterior chamber of the lens.
第11A圖一般展示典型50歲個體的水晶體103的部件以及與之相關的部件。水晶體103係為多結構系統。水晶體103的結構包括皮質113、水晶體核129、及水晶體囊袋114。囊袋114是包裹水晶體其他內部結構的外膜。水晶體上皮細胞123在水晶體赤道121處形成，而產生在圍繞眼睛水晶體的前後生長的帶狀細胞或原纖維。水晶體核129是由將皮質113相繼添加到水晶體核區域而形成。包括水晶體核129的水晶體中的各層的連續體的特徵可以是幾層、水晶體核、或水晶體核區域。這些層包括都在子宮中發育的胚胎核122及胎兒核130，從出生到四歲平均發育約三年的嬰兒核124、從約4歲發育到平均約12歲的青春期的青春期核126、及在約18歲及更大時發育的成人核128。FIG11A generally illustrates the components of the lens 103 of a typical 50-year-old individual and the components associated therewith. The lens 103 is a multi-structural system. The structure of the lens 103 includes the cortex 113, the lens nucleus 129, and the lens capsule 114. The capsule 114 is the outer membrane that surrounds the other internal structures of the lens. Lens epithelial cells 123 form at the lens equator 121 and arise from the band cells or fibrils that grow in the front and back around the lens of the eye. The lens nucleus 129 is formed by the successive addition of the cortex 113 to the lens nucleus region. The continuity of the layers in the lens, including the lens nucleus 129, can be characterized as a number of layers, the lens nucleus, or the lens nucleus region. These layers include the embryonic nucleus 122 and fetal nucleus 130, which both develop in the uterus, the infantile nucleus 124, which develops for an average of about three years from birth to age four, the pubertal nucleus 126, which develops from about age four to puberty at an average of about age 12, and the adult nucleus 128, which develops at about age 18 and older.
胚胎核122的赤道直徑（寬度）係為約0.5mm，而前後軸104（AP軸）的直徑（厚度）係為0.425mm。胎兒核130的赤道直徑係為約6.0mm，而AP軸104的直徑係為約3.0mm。嬰兒核124的赤道直徑係為約7.2mm，而AP軸104的直徑係為約3.6mm。青春期核126的赤道直徑係為約9.0mm，而AP軸104的直徑係為約4.5mm。約36歲的成年核128的赤道直徑係為約9.6mm，而AP軸104的直徑係為約4.8mm。這些都是在離體狀態下的約50歲的典型成人水晶體的平均值。因此，此水晶體（水晶體核及皮質）的赤道直徑係為約9.8mm，而AP軸104直徑係為約4.9mm。因此，水晶體的結構係為分層的或嵌套的，其中最老的層和最老的細胞朝向中心。The equatorial diameter (width) of the embryonic nucleus 122 is approximately 0.5 mm, and the diameter (thickness) of the anterior-posterior axis 104 (AP axis) is 0.425 mm. The equatorial diameter of the fetal nucleus 130 is approximately 6.0 mm, and the diameter of the AP axis 104 is approximately 3.0 mm. The equatorial diameter of the infant nucleus 124 is approximately 7.2 mm, and the diameter of the AP axis 104 is approximately 3.6 mm. The equatorial diameter of the adolescent nucleus 126 is approximately 9.0 mm, and the diameter of the AP axis 104 is approximately 4.5 mm. The equatorial diameter of the adult nucleus 128, at approximately 36 years of age, is approximately 9.6 mm, and the diameter of the AP axis 104 is approximately 4.8 mm. These are average values for a typical adult lens of approximately 50 years old, in an ex vivo state. Thus, the equatorial diameter of this lens (nucleus and cortex) is approximately 9.8 mm, and the diameter about the AP axis 104 is approximately 4.9 mm. Thus, the structure of the lens is layered or nested, with the oldest layers and cells toward the center.
水晶體是雙凸形狀，如第8圖及第8A圖所示。水晶體的前側與後側具有不同的曲率，而皮質與不同的水晶體核通常遵循這些曲率。因此，可以將水晶體視為基本上是沿著赤道軸不對稱的分層結構，並且由端到端佈置成形成基本上同心或嵌套的殼的長月牙形纖維單元所組成。這些細胞的端部對準，以在中心及中心附近區域在前側及後側形成縫合線。皮質及水晶體核中的較老組織的細胞功能減弱，在細胞形成幾個月後就失去了細胞核及其他細胞器。The lens is biconvex in shape, as shown in Figures 8 and 8A. The anterior and posterior sides of the lens have different curvatures, and the cortex and various lens nuclei generally follow these curvatures. Thus, the lens can be considered a layered structure that is essentially asymmetric about its equatorial axis and composed of long, crescent-shaped fibrous cells arranged end-to-end to form essentially concentric or nested shells. The ends of these cells align to form sutures anteriorly and posteriorly at and near the center. Older tissue cells in the cortex and lens nuclei have diminished function and lose their nuclei and other organelles within a few months of cell formation.
隨著時間的流逝，發生水晶體的壓實。每年增長的水晶體纖維的數量在整個生命中相對恆定。但是，水晶體的尺寸不會像新的光纖增長所期望的那麼大。水晶體從出生到3歲是從6mm增長到7.2mm，或者僅在3年內就增長20％。然後，在下一個大約十年中，從7.2mm增長到9mm（亦即，25％）；然而，這超過3倍以上的9年。在下一個大約20年（從12歲到36歲）中，水晶體從9mm增長到9.6mm，或者在24年內增長6.7％，顯示觀察到的生長速度顯著減慢，而我們認為纖維的生長速度在這段時期相對恆定。最後，在上述的最後大約20年（從36歲到54歲）中，水晶體僅增長很小一部分，在18年中，從9.6mm增長到9.8mm或2.1％。儘管存在需要更多水晶體纖維來填充較大外殼的幾何效應，但較舊的水晶體尺寸卻要比考慮幾何效應的纖維生長速率模型所預測的要小得多。認為包括核纖維壓實的纖維壓實可以解釋這些現象。Over time, the lens compacts. The amount of lens fiber growth each year is relatively constant throughout life. However, the lens does not increase in size as would be expected from the growth of new fibers. From birth to age 3, the lens grows from 6 mm to 7.2 mm, or 20% in just 3 years. Then, over the next decade or so, it grows from 7.2 mm to 9 mm (or 25%); however, this is more than three times the 9-year period. Over the next 20 years or so (from 12 to 36 years), the lens grows from 9 mm to 9.6 mm, or 6.7% in 24 years, representing a significant slowdown in the observed growth rate, a period during which we would expect the fiber growth rate to be relatively constant. Finally, during the last approximately 20 years (from age 36 to 54), the lens grows only slightly, from 9.6 mm to 9.8 mm, or 2.1%, over 18 years. Despite geometric effects requiring more lens fibers to fill the larger shell, the older lens size is much smaller than predicted by fiber growth rate models that account for geometric effects. Fiber compaction, including nuclear fiber compaction, is thought to explain these observations.
通常，老花眼是調節幅度的喪失。通常，屈光不正典型是由於眼睛的軸向長度的變化所引起。近視是指眼睛過長而導致焦點落在視網膜的前方。遠視是指眼睛過短而導致焦點落在視網膜的後方。通常，白內障是足以干擾視力的眼睛水晶體的混濁區域。Typically, presbyopia is a loss of accommodation. Refractive errors are typically caused by changes in the axial length of the eye. Myopia is when the eye is too long, causing focus to fall in front of the retina. Hyperopia is when the eye is too short, causing focus to fall behind the retina. Cataracts are typically areas of clouding in the lens of the eye that are large enough to interfere with vision.
老花眼最常表現為近視力缺陷，無法閱讀小字（尤其是在約40至45歲後的昏暗照明下）。老花眼或隨年齡而喪失的調節幅度係與眼睛無法改變自然晶狀水晶體的形狀有關，這使人無法在近與遠之間改變焦點，而發生在基本上是100％的人口中。研究表明，在生命的第五個十年中，調節幅度會隨著年齡的增長而穩定下降。Presbyopia most commonly manifests as a near vision defect, making it difficult to read small print (especially in dim lighting after about 40 to 45 years of age). Presbyopia, or the loss of accommodation with age, is related to the inability of the eye's natural lens to change shape, making it impossible to change focus between near and far objects. It occurs in essentially 100% of the population. Studies have shown that accommodation steadily declines with age after the fifth decade of life.
如本文所使用，除非另有說明，否則本文中的值的範圍的列舉僅意欲作為獨立指稱落入該範圍內的每一單獨值的簡寫方法。除非本文另外指出，否則可以將範圍內的每一單獨值併入說明書中，如同在本文中單獨列舉。As used herein, recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein. Unless otherwise indicated herein, each separate value within a range can be incorporated into the specification as if it were individually recited herein.
通常，除非另有說明，否則本文所使用的術語「約」意指包含±10％的變化或範圍以及與取得所述值相關聯的實驗或儀器誤差，以及較佳為其中較大者。In general, unless otherwise indicated, the term "about" as used herein is intended to encompass a variation or range of ±10% and the experimental or instrument error associated with obtaining the stated value, and preferably whichever is greater.
如本文所使用，除非另有明確說明，否則術語「超音波晶體乳化」，「超音波乳化」，「超音波乳化系統」應賦予其儘可能廣泛的構造，指稱相同的通用裝備及程序，並且通常關於使用超音波能量驅動針或尖端，以對組織（包括眼組織（例如，水晶體及白內障））進行例如切割、破碎、分離、及乳化。這樣的程序及系統亦可以包括用於抽吸、沖洗、及兩者的組件及方法。As used herein, unless expressly stated otherwise, the terms "phacoemulsification," "phacoemulsification," and "phacoemulsification system" should be given the broadest possible meaning to refer to the same general apparatus and procedures, and generally involve the use of ultrasonic energy to drive a needle or tip to perform, for example, cutting, fragmenting, separating, and emulsifying tissue, including ocular tissue (e.g., lens and cataract). Such procedures and systems may also include components and methods for aspiration, irrigation, or both.
如本文所使用，除非另有明確說明，否則術語「飛秒雷射」、「飛秒雷射束」、「飛秒脈衝」、及類似的此類術語係用於指稱脈衝持續時間，因此亦指稱雷射束的脈衝長度（亦可以指稱為脈衝寬度），而意指脈衝持續時間小於1皮秒（小於1×10-12秒）至1飛秒（fs）（1×10-15秒）的所有雷射及雷射束。As used herein, unless expressly stated otherwise, the terms "femtosecond laser,""femtosecond laser beam,""femtosecondpulse," and similar such terms are used to refer to the pulse duration, and therefore also to the pulse length (also referred to as pulse width) of the laser beam, and refer to all lasers and laser beams with pulse durations of less than 1 picosecond (less than 1×10-12 seconds) to 1 femtosecond (fs) (1×10-15 seconds).
如本文所使用，除非另有明確說明，否則術語「皮秒雷射」、「皮秒雷射束」、「皮秒脈衝」、及類似的此類術語係用於指稱脈衝持續時間，因此亦指稱雷射束的脈衝長度（亦可以指稱為脈衝寬度），而意指1皮秒（ps）（1×10-12秒）至1奈秒（ns）（1×10-9秒）的脈衝持續時間的所有雷射及雷射束。As used herein, unless expressly stated otherwise, the terms "picosecond laser,""picosecond laser beam,""picosecondpulse," and similar such terms are used to refer to the pulse duration, and therefore also to the pulse length (also referred to as pulse width) of a laser beam, and refer to all lasers and laser beams with pulse durations of 1 picosecond (ps) (1×10-12 seconds) to 1 nanosecond (ns) (1×10-9 seconds).
如本文所使用，除非另外特別說明，否則術語「遠側」及「近側」具有以下含義。對於雷射、雷射束、及雷射部件而言，遠側意指更靠近雷射束源的一側、定位、或位置。對於超音波晶體乳化系統而言，遠側意指更靠近超音波能量源的一側、定位、或位置。對於雷射、雷射束、及雷射部件而言，術語近側意指沿著雷射束路徑遠離雷射束源的一側、定位、或位置；因此，在操作上更靠近患者。對於超音波晶體乳化系統而言，術語近側意指沿著能量傳輸路徑遠離超音波能量源的一側、定位、或位置。因此，在操作上更靠近患者。相反地，在那些系統的操作期間，雷射部件或超音波晶體乳化部件的遠端遠離患者。As used herein, unless otherwise specifically stated, the terms "distal" and "proximal" have the following meanings. With respect to lasers, laser beams, and laser components, distal means a side, location, or position that is closer to the source of the laser beam. With respect to ultrasonic phacoemulsification systems, distal means a side, location, or position that is closer to the source of ultrasonic energy. With respect to lasers, laser beams, and laser components, the term proximal means a side, location, or position that is farther from the source of the laser beam along the laser beam path; thus, operationally closer to the patient. With respect to ultrasonic phacoemulsification systems, the term proximal means a side, location, or position that is farther from the source of ultrasonic energy along the energy delivery path. Thus, operationally closer to the patient. In contrast, during operation of those systems, the distal end of the laser unit or ultrasonic phacoemulsification unit is far away from the patient.
除了作為診斷工具之外，超音波波能量還具有治療用途。超音波能量可以被聚焦、定向、用於移動（例如眼動或振動）、切割裝置、工具、或尖端，以對組織進行切割、軟化、或乳化來產生薄霧及蒸汽，以及可以進行這些的組合及變化。通常，超音波晶體乳化是醫學上公認的技術，該技術使用超音波能量來移除晶狀水晶體。通常，超音波晶體乳化包括進行角膜切口、鞏膜切口、及這些中的一或更多者。超音波晶體乳化機頭藉由這些切口中之一者插入，而超音波晶體乳化機頭典型由超音波驅動的針所組成，以對自然晶狀水晶體進行例如乳化（亦即，液化），將白內障破碎成小塊，以及進行這些的組合及變化。經乳化的塊狀物隨後可以使用相同的機頭或另一機頭來移除。然後，外科醫生可以藉由切口將植入物插入眼睛。In addition to being a diagnostic tool, ultrasonic wave energy also has therapeutic uses. Ultrasonic energy can be focused, directed, used with movement (e.g., eye movement or vibration), a cutting device, tool, or tip to cut, soften, or emulsify tissue to create mist and vapor, as well as combinations and variations of these. Generally, ultrasonic phacoemulsification is a medically recognized technique that uses ultrasonic energy to remove the lens of the eye. Typically, ultrasonic phacoemulsification involves making a corneal incision, a scleral incision, or one or more of these. The phacoemulsification handpiece, which typically consists of an ultrasound-driven needle, is inserted through one of these incisions to perform procedures such as emulsification (i.e., liquefaction) of the natural lens, breaking up cataracts into smaller pieces, and combinations and variations of these. The emulsified pieces can then be removed using the same handpiece or another. The surgeon can then insert the implant into the eye through the incision.
通常，用於眼睛的治療雷射程序包括將患者放置在床或患者支撐物上，將眼睛與雷射系統的雷射束路徑對準，以及在雷射系統與眼睛之間連接患者介面。然後，利用雷射束圖案遞送治療雷射束，以在眼睛（更特定為眼睛的結構或與眼睛相關聯的結構）上進行治療雷射操作，以解決眼睛的狀況。因此，舉例而言，在本領域中已知用於解決白內障、老花眼、屈光不正（自然及誘發）、及眼睛的其他狀況的雷射程序。Typically, therapeutic laser procedures for the eye involve positioning a patient on a bed or patient support, aligning the eye with the path of a laser beam from a laser system, and connecting a patient interface between the laser system and the eye. A therapeutic laser beam is then delivered using a laser beam pattern to perform a therapeutic laser operation on the eye (more specifically, structures of the eye or structures associated with the eye) to address the condition of the eye. For example, laser procedures for addressing cataracts, presbyopia, refractive errors (natural and induced), and other conditions of the eye are known in the art.
至今為止，在手術室及醫療辦公室中，典型的醫療超音波裝置及系統（更特定為超音波晶體乳化系統）是獨立的系統，並具有自己的功率源、控制系統、監視器、控制及指令輸入、殼體、機櫃、及底座。類似地，至今為止，在手術室及醫療辦公室中，典型的醫療雷射治療裝置及系統是獨立的系統，並具有自己的功率源、控制系統、監視器、控制及指令輸入、殼體、機櫃、及底座。Until now, medical ultrasound devices and systems (more specifically, ultrasonic phacoemulsification systems) in operating rooms and medical offices have typically been standalone systems with their own power source, control system, monitor, control and command inputs, housing, cabinet, and base. Similarly, medical laser therapy devices and systems in operating rooms and medical offices have typically been standalone systems with their own power source, control system, monitor, control and command inputs, housing, cabinet, and base.
儘管該領域已經表達將超音波裝置與其他治療設備（例如，雷射）組合的需求，並且提供了一些基本組合，但是相信這種需求很大程度上沒有得到解決。至今為止，相信沒有人將治療超音波系統與另一系統（例如，治療雷射遞送系統）成功整合在一起，以提供一種可以滿足法規及醫務人員的要求及需求的緊湊而有效的醫療系統。更特定言之，在本發明之前，相信沒有人將眼用超音波晶體乳化系統與眼用治療雷射系統成功整合在一起，以提供一種滿足法規及醫務人員的要求及需求的緊湊而有效的人體工程學醫療系統。滿足這些要求及需求兩者不僅關於兩個系統的單純組合（該技術領域已經提出了這種組合）。藉由本發明滿足了這些需求，而本發明的實施例提供整合的超音波雷射，特定為滿足法規及醫務人員的要求及需求的緊湊而有效的人體工程學的醫療系統的超音波晶體乳化雷射（phaco-laser）系統。While the need to combine ultrasound devices with other therapeutic equipment (e.g., lasers) has been expressed in the field and some rudimentary combinations have been available, this need is believed to remain largely unmet. To date, it is believed that no one has successfully integrated a therapeutic ultrasound system with another system (e.g., a therapeutic laser delivery system) to provide a compact and effective medical system that meets the requirements and needs of regulatory authorities and medical practitioners. More specifically, prior to the present invention, it is believed that no one has successfully integrated an ophthalmic ultrasound phacoemulsification system with an ophthalmic therapeutic laser system to provide a compact, effective, and ergonomic medical system that meets the requirements and needs of regulatory authorities and medical practitioners. Meeting these demands and needs requires more than simply combining two systems (such a combination has already been proposed in the art). These needs are met by the present invention, and embodiments of the present invention provide an integrated phacoemulsification laser (phaco-laser) system specifically designed for a compact, efficient, and ergonomic medical system that meets regulatory and medical personnel requirements and needs.
本發明的背景技術部分意欲介紹該領域的各種態樣，這些態樣可以與本發明的實施例相關聯。因此，此部分中的前述討論提供用於更好地理解本發明的框架，並且不應被視為對先前技術的承認。The background technology section of the present invention is intended to introduce various aspects of the field that may be related to the embodiments of the present invention. Therefore, the foregoing discussion in this section provides a framework for a better understanding of the present invention and should not be regarded as an admission of prior art.
長期存在且未滿足以單獨或組合的方式解決及改善手術室及醫療辦公室的系統的尺寸、操作治療室的人體工程學、手術系統及裝備、有效進行程序所需要的時間、患者的舒適度的需要。這些長期的需求已經存在並持續，而在眼科學領域尤其如此，並包括解決白內障，解決基於屈光的問題，解決老花眼，解決眼睛的疾病、狀況、及外傷，以及針對眼睛及附近結構的狀況的其他手術程序。藉由提供本說明書、圖式、及請求項中所闡述的製品、裝置、及方法，本發明解決了這些及其他需求。There are long-standing and unmet needs to address and improve operating room and medical office system size, operating room ergonomics, surgical systems and equipment, time required for efficient procedure execution, and patient comfort, either individually or in combination. These long-standing needs have existed and continue to exist, particularly in the field of ophthalmology, and include addressing cataracts, refractive-based problems, presbyopia, diseases, conditions, and injuries of the eye, and other surgical procedures for conditions of the eye and adjacent structures. The present invention addresses these and other needs by providing the articles, devices, and methods described in the specification, drawings, and claims.
因此，提供所請求的發明以及說明書及圖式中所提供的實施例。Thus, the claimed invention and the embodiments provided in the specification and drawings are provided.
此外，提供一種雷射系統，具有：治療雷射系統，具有殼體；患者位置決定系統；具有第一部件及第二部件；第一部件係與治療雷射系統機械關聯；第二部件不與治療雷射系統機械關聯，由此第二部件獨立於治療雷射系統，而藉此相對於治療雷射系統自由移動；以及其中第一部件、第二部件、或二者經配置以決定相對於第一部件的第二部件的相對位置。In addition, a laser system is provided, comprising: a therapeutic laser system having a housing; a patient position determination system; having a first component and a second component; the first component being mechanically associated with the therapeutic laser system; the second component being not mechanically associated with the therapeutic laser system, such that the second component is independent of the therapeutic laser system and thereby freely movable relative to the therapeutic laser system; and wherein the first component, the second component, or both are configured to determine a relative position of the second component relative to the first component.
此外，提供一種雷射超音波系統，具有：治療雷射系統；超音波晶體乳化系統，用於提供治療超音波能量；以及安全互鎖，由此當超音波晶體乳化系統處於操作狀態時，防止雷射系統擊發雷射。In addition, a laser ultrasound system is provided, comprising: a therapeutic laser system; an ultrasonic phacoemulsification system for providing therapeutic ultrasound energy; and a safety interlock, thereby preventing the laser system from firing when the ultrasonic phacoemulsification system is in an operational state.
更進一步地，提供一種雷射超音波系統，具有：治療雷射系統；超音波晶體乳化系統，用於提供治療超音波能量；以及整合到系統中的顯微鏡。Furthermore, a laser ultrasound system is provided, comprising: a therapeutic laser system; an ultrasonic phacoemulsification system for providing therapeutic ultrasound energy; and a microscope integrated into the system.
此外，提供一種雷射超音波系統，具有：治療雷射系統；超音波晶體乳化系統，用於提供治療超音波能量；沙姆（Scheimpflug）相機構件，用於決定眼睛的結構的形狀、位置、及兩者。In addition, a laser ultrasound system is provided, comprising: a therapeutic laser system; an ultrasonic phacoemulsification system for providing therapeutic ultrasonic energy; and a Scheimpflug camera element for determining the shape, position, or both of structures of the eye.
此外，提供這些雷射系統、雷射超音波系統、雷射超音波乳化系統、毫微微超音波乳化系統、方法、及裝置，具有下列特徵中之一或更多者：其中雷射系統具有整合超音波系統；其中超音波系統係容納在治療雷射殼體內；其中超音波系統係為超音波晶體乳化系統；具有雷射安全互鎖，由此在使用超音波系統時不能發射雷射；其中治療雷射系統係為飛秒雷射系統；其中超音波系統係為超音波晶體乳化系統；其中患者位置決定系統具有選自A/C電磁追蹤系統、電磁追蹤系統、陀螺儀、加速度計、及磁力計所組成的群組的裝置；其中患者位置決定系統具有選自羅盤、雷射位置決定裝置、音波位置決定裝置、RFID裝置所組成的群組的裝置；其中治療雷射系統具有從殼體伸出的臂；其中治療雷射系統具有從殼體伸出的臂，並且在該臂的近端處具有雷射遞送頭；其中所決定的相對位置係在二維空間中；其中所決定的相對位置係在3維空間中；其中患者決定系統具有至少95％的精確度；其中患者決定系統具有至少98％的精確度；其中患者決定系統具有至少99％的精確度；其中該系統經配置以決定臂與患者縱向軸線的角度，並且至少部分依據該角度來調整治療雷射束圖案；其中該角度係決定為在精確度的±5度內；其中該角度係決定為在精確度的±3度以內；其中該角度係決定為在精確度的±2度內；其中患者位置決定系統的第二部件係容納在患者頭枕中；其中治療雷射系統具有用於患者位置決定系統的第二部件的充電站；其中該系統具有PID；其中PID具有彎月形反向器；其中PID包含臂，且其中該臂定義真空通道及生理鹽水通道；其中該系統具有定義四個瞳孔的光學裝置，且其中雷射束路徑延伸通過瞳孔中的兩個；以及其中在瞳孔處係為共軛端心（telocentric）瞳孔。In addition, these laser systems, laser ultrasound systems, laser phacoemulsification systems, femto-phacoemulsification systems, methods, and apparatus are provided, having one or more of the following features: wherein the laser system has an integrated ultrasound system; wherein the ultrasound system is housed within a therapeutic laser housing; wherein the ultrasound system is an ultrasound phacoemulsification system; wherein the laser system has a laser safety interlock, thereby preventing laser discharge while the ultrasound system is in use; wherein the therapeutic laser system is a femtosecond laser system; wherein the ultrasound system is an ultrasound phacoemulsification system wherein the patient position determination system comprises a device selected from the group consisting of an A/C electromagnetic tracking system, an electromagnetic tracking system, a gyroscope, an accelerometer, and a magnetometer; wherein the patient position determination system comprises a device selected from the group consisting of a compass, a laser position determination device, an acoustic position determination device, and an RFID device; wherein the therapeutic laser system comprises an arm extending from the housing; wherein the therapeutic laser system comprises an arm extending from the housing and having a laser delivery head at a proximal end of the arm; wherein the determined relative position is in two-dimensional space; wherein wherein the relative position determined is in 3-dimensional space; wherein the patient determines the system with an accuracy of at least 95%; wherein the patient determines the system with an accuracy of at least 98%; wherein the patient determines the system with an accuracy of at least 99%; wherein the system is configured to determine an angle between the arm and a longitudinal axis of the patient and to adjust a therapeutic laser beam pattern based at least in part on the angle; wherein the angle is determined to within an accuracy of ±5 degrees; wherein the angle is determined to within an accuracy of ±3 degrees; wherein the angle is determined to within an accuracy of ±2 degrees wherein the second component of the patient positioning system is housed in the patient headrest; wherein the therapeutic laser system has a charging station for the second component of the patient positioning system; wherein the system has a PID; wherein the PID has a meniscus-shaped inverter; wherein the PID includes an arm, and wherein the arm defines a vacuum channel and a saline channel; wherein the system has an optical device defining four pupils, and wherein the laser beam path extends through two of the pupils; and wherein the pupils are telocentric.
進一步提供一種雷射超音波系統，具有：組件，該組件具有：治療雷射，用於沿著雷射束路徑提供治療雷射束；超音波晶體乳化系統，用於提供治療超音波能量；臂，附接至組件；該臂具有遠端及近端，其中遠端係附接至組件；其中近端具有雷射遞送頭；該臂容納雷射束遞送路徑的一部分；其中該組件相對於患者位置成一角度進行定位，其中該角度係由該臂的縱向軸線與患者軸線所定義；該角度係為30度至320度。Further provided is a laser ultrasound system having: an assembly having: a therapeutic laser for providing a therapeutic laser beam along a laser beam path; an ultrasonic phacoemulsification system for providing therapeutic ultrasound energy; an arm attached to the assembly; the arm having a distal end and a proximal end, wherein the distal end is attached to the assembly; wherein the proximal end has a laser delivery head; the arm accommodates a portion of the laser beam delivery path; wherein the assembly is positioned at an angle relative to a patient position, wherein the angle is defined by a longitudinal axis of the arm and an axis of the patient; and the angle is between 30 degrees and 320 degrees.
此外，進一步提供這些雷射系統、雷射超音波系統、雷射超音波乳化系統、毫微微超音波乳化系統、方法、及裝置，具有下列特徵中之一或更多者：其中該角度選自由45°、90°、135°、180°、225°、270°、及315°所組成的角度的群組；其中該臂經配置以環繞組件上的樞軸點進行弧形移動；其中該臂經配置以用於水平移動，由此該臂可以從組件伸出及縮回；其中該臂、該雷射頭、或二者經配置以用於垂直移動；其中具有該臂的雷射束路徑中的雷射束並未準直；其中具有該臂的雷射束路徑中的雷射束係在光纖內；具有定義四個瞳孔的光學裝置，且其中雷射束路徑延伸通過四個瞳孔；其中在瞳孔處係為共軛端心瞳孔；具有用於決定相對於組件的患者位置的構件；其中用於決定患者位置的構件具有第一部件與第二部件；其中第一部件係與雷射超音波系統機械關聯；其中第二部件並未附接至治療雷射系統，由此第二部件獨立於治療雷射系統，並藉此相對於治療雷射系統自由移動；以及其中第一部件、第二部件、或二者經配置以決定相對於第一部件的第二部件的相對位置；其中治療雷射超音波系統具有用於患者位置決定系統的第二部件的充電站；其中雷射系統與超音波晶體乳化系統是整合的；其中雷射系統與超音波晶體乳化系統係容納在殼體內。其中該組件係容納在殼體內；具有雷射安全互鎖，由此在使用超音波晶體乳化系統時無法發射雷射；以及其中治療雷射係為飛秒雷射。Furthermore, there are provided laser systems, laser ultrasound systems, laser sonication systems, femto-sonic sonication systems, methods, and apparatus having one or more of the following features: wherein the angle is selected from the group consisting of 45°, 90°, 135°, 180°, 225°, 270°, and 315°; wherein the arm is configured for arcuate movement about a pivot point on the assembly; wherein the arm is configured for horizontal movement such that the arm can be extended and retracted from the assembly; wherein the arm, the laser head, or both are configured for vertical movement; wherein a laser beam in a laser beam path with the arm is uncollimated; wherein a laser beam in a laser beam path with the arm is within an optical fiber; wherein the optical device defines four pupils, and wherein the laser beam path a diameter extending through four pupils; wherein the pupils are concentrically located at the pupils; having a structure for determining a patient position relative to the assembly; wherein the structure for determining the patient position has a first component and a second component; wherein the first component is mechanically associated with the laser ultrasound system; wherein the second component is not attached to the therapeutic laser system, whereby the second component is independent of the therapeutic laser system and thereby freely moves relative to the therapeutic laser system; and wherein the first component, the second component, or both are configured to determine a relative position of the second component relative to the first component; wherein the therapeutic laser ultrasound system has a charging station for the second component of the patient position determination system; wherein the laser system and the ultrasonic phacoemulsification system are integrated; wherein the laser system and the ultrasonic phacoemulsification system are housed in a housing. The component is housed within a housing; has a laser safety interlock, thereby preventing laser discharge when the ultrasonic phacoemulsification system is in use; and the therapeutic laser is a femtosecond laser.
進一步提供一種雷射超音波系統，具有：治療雷射，用於沿著雷射束路徑提供治療雷射束；超音波晶體乳化系統，用於提供治療超音波能量；以及光學裝置，用於定義四個瞳孔，且其中雷射束路徑延伸通過至少兩個瞳孔。Further provided is a laser ultrasound system having: a therapeutic laser for providing a therapeutic laser beam along a laser beam path; a ultrasonic phacoemulsification system for providing therapeutic ultrasound energy; and an optical device for defining four pupils, wherein the laser beam path extends through at least two of the pupils.
此外，提供這些雷射系統、雷射超音波系統、雷射超音波乳化系統、毫微微超音波乳化系統、方法、及裝置，具有下列特徵中之一或更多者：其中在瞳孔處係為共軛端心瞳孔；其中治療雷射與超音波晶體乳化系統是整合的；其中治療雷射與超音波晶體乳化系統係容納在殼體內；具有雷射安全互鎖，由此在使用超音波系統時無法發射雷射；以及其中治療雷射系統係為飛秒雷射系統。Additionally, laser systems, laser ultrasound systems, laser phacoemulsification systems, femtophacoemulsification systems, methods, and apparatus are provided having one or more of the following features: wherein the pupil is concentrically located; wherein the therapeutic laser and the phacoemulsification system are integrated; wherein the therapeutic laser and the phacoemulsification system are housed within a housing; wherein there is a laser safety interlock, thereby preventing the laser from firing while the ultrasound system is in use; and wherein the therapeutic laser system is a femtosecond laser system.
此外，提供一種雷射超音波系統，具有：用於提供第一及第二治療雷射束的構件；該系統具有用於定義雷射束路徑的光學裝置；第一及第二雷射束路徑沿著雷射束路徑行進；其中第一治療雷射束具有約1000fs至約2000fs的脈衝寬度；該系統具有用於執行利用第一治療雷射束的水晶體切割的雷射束遞送圖案；其中第二治療雷射束具有約100fs至約500fs的脈衝寬度；該系統具有用於利用第二治療雷射束的角膜切割的雷射束遞送圖案；超音波晶體乳化系統，用於提供治療超音波能量。Additionally, a laser ultrasound system is provided, comprising: components for providing first and second therapeutic laser beams; the system having an optical device for defining laser beam paths; the first and second laser beam paths traveling along the laser beam paths; wherein the first therapeutic laser beam has a pulse width of approximately 1000 fs to approximately 2000 fs; the system having a laser beam delivery pattern for performing crystalline ablation using the first therapeutic laser beam; wherein the second therapeutic laser beam has a pulse width of approximately 100 fs to approximately 500 fs; the system having a laser beam delivery pattern for performing corneal ablation using the second therapeutic laser beam; and an ultrasonic phacoemulsification system for providing therapeutic ultrasound energy.
進一步提供這些雷射系統、雷射超音波系統、雷射超音波乳化系統、毫微微超音波乳化系統、方法、及裝置，具有下列特徵中之一或更多者：其中第一雷射束的波長係為1030nm；其中第二雷射束的波長係為1030nm；其中第一雷射束的波長係為1030nm，而第二雷射束的波長係為1030nm；其中重複率係為320kHz或更少。Further provided are these laser systems, laser ultrasound systems, laser sonication systems, femto-sonic sonication systems, methods, and apparatus having one or more of the following characteristics: wherein the wavelength of the first laser beam is 1030 nm; wherein the wavelength of the second laser beam is 1030 nm; wherein the wavelength of the first laser beam is 1030 nm and the wavelength of the second laser beam is 1030 nm; wherein the repetition rate is 320 kHz or less.
進一步提供這些雷射系統、雷射超音波系統、雷射超音波乳化系統、毫微微超音波乳化系統、方法、及裝置，具有下列特徵中之一或更多者：其中具有沙姆相機構件；其中沙姆相機構件具有n個相機，其中至少n-1個相機在30度至320度的任何患者角度下都具有患者眼睛的遮擋視圖；其中n係為5；其中n係為6；以及其中相機具有至少40度的間隔。Further provided are these laser systems, laser ultrasound systems, laser phacoemulsification systems, femtophacoemulsification systems, methods, and apparatus having one or more of the following features: having a Sham camera assembly; wherein the Sham camera assembly has n cameras, wherein at least n-1 cameras have an occluded view of the patient's eye at any patient angle from 30 degrees to 320 degrees; wherein n is 5; wherein n is 6; and wherein the cameras are spaced at least 40 degrees apart.
此外，提供一種雷射超音波系統，具有：第一配置，用於向患者提供治療雷射束；以及第二配置，用於針對患者進行超音波晶體乳化程序；以及其中從第一配置到第二配置的轉變花費少於5分鐘。Additionally, a laser ultrasound system is provided having: a first configuration for delivering a therapeutic laser beam to a patient; and a second configuration for performing a phacoemulsification procedure on the patient; and wherein transitioning from the first configuration to the second configuration takes less than 5 minutes.
進一步提供這些雷射系統、雷射超音波系統、雷射超音波乳化系統、毫微微超音波乳化系統、方法、及裝置，具有下列特徵中之一或更多者：其中從雷射到超音波乳化的轉變少於3分鐘；其中從雷射到超音波乳化的轉變少於2分鐘；其中從雷射到超音波乳化的轉變少於1分鐘；其中從雷射到超音波乳化的轉變少於45秒；其中從雷射到超音波乳化的轉變係為約30秒；其中從雷射到超音波乳化的轉變係為約1分鐘至30秒。Further provided are these laser systems, laser ultrasound systems, laser phacoemulsification systems, femtophacoemulsification systems, methods, and apparatus having one or more of the following characteristics: wherein the transition from laser to phacoemulsification is less than 3 minutes; wherein the transition from laser to phacoemulsification is less than 2 minutes; wherein the transition from laser to phacoemulsification is less than 1 minute; wherein the transition from laser to phacoemulsification is less than 45 seconds; wherein the transition from laser to phacoemulsification is about 30 seconds; wherein the transition from laser to phacoemulsification is between about 1 minute and 30 seconds.
進一步提供這些雷射系統、雷射超音波系統、雷射超音波乳化系統、毫微微超音波乳化系統、方法、及裝置，具有下列特徵中之一或更多者：其中從毫微微雷射到超音波乳化的轉變少於3分鐘；其中從毫微微雷射到超音波乳化的轉變少於2分鐘；其中從毫微微雷射到超音波乳化的轉變少於1分鐘；其中從毫微微雷射到超音波乳化的轉變少於45秒；其中從毫微微雷射到超音波乳化的轉變係為約30秒；其中從毫微微雷射到超音波乳化的轉變係為約1分鐘至30秒。Further provided are these laser systems, laser ultrasound systems, laser phacoemulsification systems, femtophacoemulsification systems, methods, and apparatus having one or more of the following characteristics: wherein the transition from femtolaser to phacoemulsification is less than 3 minutes; wherein the transition from femtolaser to phacoemulsification is less than 2 minutes; wherein the transition from femtolaser to phacoemulsification is less than 1 minute; wherein the transition from femtolaser to phacoemulsification is less than 45 seconds; wherein the transition from femtolaser to phacoemulsification is about 30 seconds; wherein the transition from femtolaser to phacoemulsification is between about 1 minute and 30 seconds.
進一步提供一種雷射超音波系統，具有：用於定義佔地面積及體積的組件；該組件具有：治療雷射系統；以及超音波晶體乳化系統，用於提供治療超音波能量；以及其中佔地面積係小於1500平方英吋。Further provided is a laser ultrasound system having: an assembly for defining a footprint and a volume; the assembly having: a therapeutic laser system; and an ultrasonic phacoemulsification system for providing therapeutic ultrasound energy; and wherein the footprint is less than 1500 square inches.
進一步提供這些雷射系統、雷射超音波系統、雷射超音波乳化系統、毫微微超音波乳化系統、方法、及裝置，具有下列特徵中之一或更多者：其中佔地面積係為約33英吋×約22英吋；其中佔地面積係為約35英吋或更少×約35英吋或更少；其中佔地面積係為約35英吋或更少×約22英吋或更少；其中佔地面積係為約400平方英吋至約800平方英吋；其中體積小於約40立方英呎；其中體積小於約35立方英呎；其中體積小於約30立方英呎；其中體積小於約25立方英呎；以及其中體積小於約20立方英呎。Further provided are these laser systems, laser sonication systems, laser sonication systems, femto sonication systems, methods, and apparatus having one or more of the following characteristics: wherein the footprint is about 33 inches by about 22 inches; wherein the footprint is about 35 inches or less by about 35 inches or less; wherein the footprint is about 35 inches or less by about 22 inches or less; wherein the footprint is about 400 square inches to about 800 square inches; wherein the volume is less than about 40 cubic feet; wherein the volume is less than about 35 cubic feet; wherein the volume is less than about 30 cubic feet; wherein the volume is less than about 25 cubic feet; and wherein the volume is less than about 20 cubic feet.
此外，提供一種雷射超音波系統，具有：治療雷射系統；該治療雷射系統具有：臂，具有近端；雷射頭，附接至該臂的近端；以及電子裝置，用於操作治療雷射系統；超音波晶體乳化系統，用於提供治療超音波能量，並具有用於操作該超音波晶體乳化系統的電子裝置；以及雷射頭與用於超音波晶體乳化系統的電子裝置及用於治療雷射系統的電子裝置電隔離。In addition, a laser ultrasound system is provided, comprising: a therapeutic laser system; the therapeutic laser system having: an arm having a proximal end; a laser head attached to the proximal end of the arm; and electronics for operating the therapeutic laser system; an ultrasonic phacoemulsification system for providing therapeutic ultrasound energy and having electronics for operating the ultrasonic phacoemulsification system; and the laser head being electrically isolated from the electronics for the ultrasonic phacoemulsification system and the electronics for the therapeutic laser system.
進一步提供一種雷射系統，具有：治療雷射束，用於提供治療雷射束；以及用於定義雷射束路徑的光學裝置；其中雷射束路徑大於300mm；由此，雷射束圖案沿著雷射束路徑傳輸，而雷射束圖案不會擴展。Further provided is a laser system having: a therapeutic laser beam for providing the therapeutic laser beam; and an optical device for defining a laser beam path; wherein the laser beam path is greater than 300 mm; whereby a laser beam pattern is transmitted along the laser beam path without expansion of the laser beam pattern.
此外，提供一種雷射系統，具有：治療雷射束，用於提供治療雷射束；以及用於定義雷射束路徑的光學裝置；其中雷射束路徑大於300mm；由此，雷射束圖案沿著雷射束路徑傳輸，而沒有任何波前誤差。Furthermore, a laser system is provided having: a therapeutic laser beam for providing the therapeutic laser beam; and an optical device for defining a laser beam path; wherein the laser beam path is greater than 300 mm; whereby a laser beam pattern is transmitted along the laser beam path without any wavefront error.
此外，提供一種雷射系統，具有：治療雷射束，用於提供治療雷射束；以及用於定義雷射束路徑的光學裝置；其中雷射束路徑大於300mm；由此，雷射束圖案沿著雷射束路徑傳輸，而沒有像差。Furthermore, a laser system is provided having: a therapeutic laser beam for providing the therapeutic laser beam; and an optical device for defining a laser beam path; wherein the laser beam path is greater than 300 mm; whereby a laser beam pattern is transmitted along the laser beam path without aberrations.
進一步，提供這些雷射系統、雷射超音波系統、雷射超音波乳化系統、毫微微超音波乳化系統、方法、及裝置，具有下列特徵中之一或更多者：其中雷射係為飛秒雷射，並且進一步具有整合的超音波晶體乳化系統。Furthermore, these laser systems, laser ultrasound systems, laser phacoemulsification systems, femtophacoemulsification systems, methods, and devices are provided, having one or more of the following features: wherein the laser is a femtosecond laser, and further having an integrated phacoemulsification system.
此外，提供這些雷射系統、雷射超音波系統、雷射超音波乳化系統、毫微微超音波乳化系統、方法、及裝置，具有下列特徵中之一或更多者：具有虹膜配準裝置。In addition, these laser systems, laser ultrasound systems, laser phacoemulsification systems, femtophacoemulsification systems, methods, and devices are provided, having one or more of the following features: having an iris registration device.
此外，提供這些雷射系統、雷射超音波系統、雷射超音波乳化系統、毫微微超音波乳化系統、方法、及裝置，具有下列特徵中之一或更多者：其中超音波系統與雷射系統之間的資料及資訊進行交換；其中資訊具有白內障的等級；其中來自雷射系統的資訊係用於提供推薦的超音波能量。Additionally, laser systems, laser ultrasound systems, laser phacoemulsification systems, femtophacoemulsification systems, methods, and apparatus are provided having one or more of the following features: wherein data and information are exchanged between the ultrasound system and the laser system; wherein the information includes the level of cataract; and wherein the information from the laser system is used to provide a recommended ultrasound energy.
此外，提供這些雷射系統、雷射超音波系統、雷射超音波乳化系統、毫微微超音波乳化系統、方法、及裝置，具有下列特徵中之一或更多者：其中超音波系統與雷射系統之間的資料及資訊進行交換；以及其中資訊具有白內障的等級。Additionally, these laser systems, laser ultrasound systems, laser phacoemulsification systems, femtophacoemulsification systems, methods, and apparatus are provided having one or more of the following characteristics: wherein data and information are exchanged between the ultrasound system and the laser system; and wherein the information is of cataract grade.
此外，提供這些雷射系統、雷射超音波系統、雷射超音波乳化系統、毫微微超音波乳化系統、方法、及裝置，具有下列特徵中之一或更多者：具有OCT成像構件。In addition, these laser systems, laser ultrasound systems, laser phacoemulsification systems, femtophacoemulsification systems, methods, and devices are provided, having one or more of the following features: having an OCT imaging component.
此外，提供這些雷射系統、雷射超音波系統、雷射超音波乳化系統、毫微微超音波乳化系統、方法、及裝置，具有下列特徵中之一或更多者：其中該系統具有佔地面積尺寸；以及其中佔地面積尺寸選自少於35×少於35英吋、少於35×25英吋、約35×25英吋、約33×22英吋、及約400平方英吋至約800平方英吋所組成的尺寸群組。Additionally, provided are laser systems, laser ultrasound systems, laser sonication systems, femto-sonic sonication systems, methods, and apparatus having one or more of the following characteristics: wherein the system has a footprint; and wherein the footprint is selected from the group consisting of less than 35 x less than 35 inches, less than 35 x 25 inches, approximately 35 x 25 inches, approximately 33 x 22 inches, and approximately 400 square inches to approximately 800 square inches.
此外，提供這些雷射系統、雷射超音波系統、雷射超音波乳化系統、毫微微超音波乳化系統、方法、及裝置，具有下列特徵中之一或更多者：具有定位於雷射束路徑中的雷射頭上的帽，由此當雷射未處於可操作配置時，光學部件得到保護。Additionally, these laser systems, laser ultrasound systems, laser ultrasound emulsification systems, femto ultrasound emulsification systems, methods, and apparatus are provided having one or more of the following features: having a cap positioned on the laser head in the laser beam path, whereby the optical components are protected when the laser is not in an operational configuration.
進一步提供利用這些雷射系統、雷射超音波系統、雷射超音波乳化系統、毫微微超音波乳化系統中之任一者執行雷射操作及超音波晶體乳化操作的方法。Further provided are methods for performing laser operations and ultrasonic phacoemulsification operations using any of these laser systems, laser ultrasonic systems, laser phacoemulsification systems, and femtophacoemulsification systems.
般而言，本發明的實施例提供用於解決眼睛（包括角膜、自然晶狀水晶體、及與眼睛相關聯的其他結構）的狀況（並且更特定為用於遞送雷射能量及超音波能量）以及用於解決、緩解、改善、及反轉這些狀況的系統及方法。Generally speaking, embodiments of the present invention provide systems and methods for addressing conditions of the eye (including the cornea, the natural lens, and other structures associated with the eye), and more particularly for delivering laser energy and ultrasonic energy, and for addressing, alleviating, improving, and reversing these conditions.
一般而言，本發明的實施例係關於人體工學系統、整合系統、及這些的組合及變化，並提供使用超音波及雷射束來針對人類眼睛及其相關結構的狀況進行診斷、治療、及這些的組合及變化的能力。在本系統的實施例中，雷射及超音波部件係整合進入單一裝置，該單一裝置經配置以將治療超音波能量及雷射能量操作、控制、及遞送至眼睛。這些整合裝置的實施例可以具有：整合及互動式控制系統；整合患者資訊系統；整合計費系統；整合電子病歷；雷射與超音波系統之間的整合及互動式操作、控制、遞送、及這些系統的組合；雷射與超音波系統之間的包括安全系統的整合及互動式協定；整合及互動式輸入系統，用於讓外科醫生及從業人員將資訊及指令輸入至裝置；整合及互動式監測系統、顯示器、及二者；整合及共同功率源及功率管理；整合的熱負載（例如，熱）管理；無干擾的能量產生及遞送系統；以及這些特徵以及其他特徵的組合及變化。In general, embodiments of the present invention relate to ergonomic systems, integrated systems, and combinations and variations thereof, that provide the ability to use ultrasound and laser beams to diagnose, treat, and treat conditions of the human eye and its associated structures. In embodiments of the present system, the laser and ultrasound components are integrated into a single device that is configured to manipulate, control, and deliver therapeutic ultrasound energy and laser energy to the eye. Embodiments of these integrated devices may have: an integrated and interactive control system; an integrated patient information system; an integrated billing system; an integrated electronic medical record; integrated and interactive operation, control, delivery between laser and ultrasound systems, and combinations of these systems; an integrated and interactive protocol between laser and ultrasound systems, including safety systems; an integrated and interactive input system for surgeons and practitioners to input information and commands into the device; an integrated and interactive monitoring system, display, and both; an integrated and common power source and power management; integrated thermal load (e.g., heat) management; an interference-free energy generation and delivery system; and combinations and variations of these and other features.
在實施例中，這些整合裝置或系統係與患者支撐床相關聯，並形成進一步系統。在較佳實施例中，這些裝置及此患者支撐床經配置以允許外科醫生藉由多種途徑進入患者的左眼及右眼，而不需要患者的移動或重新佈置。因此，系統的此較佳實施例允許外科醫生基於接近眼睛的一或二者的外科醫生個體較佳方法而容易定位患者，而不需要重新定位患者，並且不需要重新配置雷射、超音波、及二者。以此方式，增強患者的順應性，增強外科醫生的人體工程學，增強效率，增強功效，減少完成患者的整個程序（例如，雙眼）的時間，以及這些的組合及變化，並且可以取得其他益處。In embodiments, these integrated devices or systems are associated with a patient support couch to form a further system. In a preferred embodiment, these devices and the patient support couch are configured to allow the surgeon to access the patient's left and right eyes via multiple approaches without requiring the patient to be moved or repositioned. Thus, this preferred embodiment of the system allows the surgeon to easily position the patient based on the surgeon's individual best approach to one or both eyes without requiring repositioning the patient and without requiring reconfiguration of the laser, ultrasound, or both. In this way, patient compliance is enhanced, surgeon ergonomics are enhanced, efficiency is enhanced, efficacy is enhanced, the time to complete the entire procedure for a patient (e.g., bilaterally) is reduced, and combinations and variations of these, and other benefits can be achieved.
在實施例中，患者係定位於患者支撐件（例如，支撐床）上。然後，將系統移動至患者附近的位置。外科醫生可以在本說明書所描述的多種定向中之任一者上定位系統。然後，使用雷射系統及超音波系統來對患者進行程序。In one embodiment, a patient is positioned on a patient support (e.g., a support couch). The system is then moved into position adjacent to the patient. The surgeon can position the system in any of the various orientations described herein. The procedure is then performed on the patient using the laser system and the ultrasound system.
這些系統的實施例（例如，整合超音波晶體乳化液雷射系統的實施例）經配置而能夠解決眼睛的各種狀況，並且能夠在眼睛上執行各種程序，包括例如：晶狀體囊切開；客製化形狀的非圓形及非橢圓形晶狀體囊切開；水晶體切割、破碎、切片、及移除；白內障切割、破碎、分離、及移除；水晶體及白內障組織的乳化；角膜切割及切口；角膜瓣及袋的建立；進行角膜緣鬆弛切口；解決及校正屈光不正（自然及誘發）；殘留皮質材料的移除；水晶體上皮細胞的移除；與前玻璃體切除相關聯的玻璃體抽吸及切割；解決雙極凝血；以及人工水晶體注射。Embodiments of these systems (e.g., embodiments integrating a phacoemulsification laser system) are configured to address a variety of ocular conditions and to perform a variety of procedures on the eye, including, for example: capsulotomy; custom-shaped non-circular and non-elliptical capsulotomies; lens cutting, fragmentation, slicing, and removal; cataract cutting, fragmentation, separation, and removal; emulsification of lens and cataract tissue; corneal cutting and incisions; creation of corneal flaps and pockets; performing limbal relaxing incisions; addressing and correcting refractive errors (natural and induced); removal of residual cortical material; removal of lens epithelial cells; vitreous aspiration and cutting associated with anterior vitrectomy; addressing bipolar coagulation; and intraocular lens injections.
這些系統的實施例（例如，整合超音波晶體乳化器雷射系統的實施例）經配置而能夠解決眼睛的各種狀況，並且能夠執行包括放射狀角膜切開術（RK）、散光性角膜切開術（AK）、角膜緣鬆弛切口（LRI）、及這些的組合及變化的各種程序。這些切口可以在超音波乳化程序及水晶體植入之前或之後藉由雷射進行。RK包括微RK、微RK/AK、及傳統RK，而微RK係為較佳的。對於微RK而言，可以在光學區域中使用徑向切口，該光學區域較佳為較大的約5.00mm及更大，但是亦可以設想較小的區域。切口的長度通常為約2.50mm。切口的典型參數係在表1中列出。通常，在微RK程序中，1、2、3或更多個切口係形成於角膜上。 表1
在這些系統的實施例中，相關聯患者支撐床係為智慧型患者支撐床。此智慧型患者支撐床具有位置決定裝置（例如，定位裝置、RFID、光學裝置、加速度計、感測器、位置裝置等），該等位置決定裝置係與雷射超音波裝置通訊，以提供相對於雷射束遞送部件、雷射束路徑、雷射對接部件、超音波部件、組合的雷射超音波裝置、及這些的組合及變化的患者的確切位置（更特定為患者的頭部）。In embodiments of these systems, the associated patient support couch is a smart patient support couch having position-determining devices (e.g., positioning devices, RFID, optical devices, accelerometers, sensors, position devices, etc.) that communicate with the laser ultrasound device to provide the patient's precise position (more specifically, the patient's head) relative to the laser beam delivery component, the laser beam path, the laser docking component, the ultrasound component, the combined laser ultrasound device, and any combinations and variations thereof.
在這些系統的實施例中，存在可以與任何標準患者支撐件（例如，患者支撐床）相關聯的相關聯智慧型頭枕。此智慧型頭枕具有位置決定裝置（例如，定位裝置、RFID、光學裝置、加速度計、感測器、位置裝置等），該等位置決定裝置係與雷射超音波裝置通訊，以提供相對於雷射束遞送部件、雷射束路徑、雷射對接部件、超音波部件、組合的雷射超音波裝置、及這些的組合及變化的患者的確切位置（更特定為患者的頭部）。In embodiments of these systems, there is an associated smart headrest that can be associated with any standard patient support (e.g., a patient support couch). The smart headrest has position-determining devices (e.g., positioning devices, RFID, optical devices, accelerometers, sensors, position devices, etc.) that communicate with the laser ultrasound device to provide the patient's exact position (more specifically, the patient's head) relative to the laser beam delivery component, the laser beam path, the laser docking component, the ultrasound component, the combined laser ultrasound device, and any combinations and variations thereof.
在這些系統的實施例中，存在可以與患者的頭部或頸部相關聯（例如，由患者所穿戴或放置）的相關聯患者智慧型裝置（例如，患者標籤、帶、或帽）。此患者智慧型裝置具有位置決定裝置（例如，定位裝置、RFID、光學裝置、加速度計、感測器、位置裝置等），該等位置決定裝置係與雷射超音波裝置通訊，以提供相對於雷射束遞送部件、雷射束路徑、雷射對接部件、超音波部件、組合的雷射超音波裝置、及這些的組合及變化的患者的確切位置（更特定為患者的頭部）。In embodiments of these systems, there is an associated patient intelligence device (e.g., a patient tag, band, or cap) that can be associated with (e.g., worn or placed by) the patient's head or neck. The patient intelligence device has a position-determining device (e.g., a positioning device, RFID, an optical device, an accelerometer, a sensor, a position device, etc.) that communicates with the laser ultrasound device to provide the patient's exact position (more specifically, the patient's head) relative to the laser beam delivery component, the laser beam path, the laser docking component, the ultrasound component, the combined laser ultrasound device, and any combinations and variations thereof.
用於決定相對於雷射的位置與雷射束路徑的患者的位置（例如，患者的頭部）的用於患者的位置決定裝置（亦指稱為用於患者的定向/定位追蹤系統）可以是例如電磁追蹤系統（例如，Polhemus Patriot™ 6-DOF）。在美國專利5,307,072、6,369,594、6,400,139、6,624,626、7,710,395、6,762,600、7,292,948、7,873,491、及8,013,595中揭示及教示這樣的追蹤系統的實施例，每一者的全部揭示內容藉由引用併入本文。這樣的裝置亦可以指稱為患者定位器或患者定位裝置或系統。A patient position determination device (also referred to as a patient orientation/position tracking system) for determining the position of a patient (e.g., the patient's head) relative to the position of a laser and the path of a laser beam can be, for example, an electromagnetic tracking system (e.g., the Polhemus Patriot™ 6-DOF). Examples of such tracking systems are disclosed and taught in U.S. Patents 5,307,072, 6,369,594, 6,400,139, 6,624,626, 7,710,395, 6,762,600, 7,292,948, 7,873,491, and 8,013,595, the entire disclosures of each of which are incorporated herein by reference. Such a device may also be referred to as a patient positioner, patient positioning device, or system.
在優先權文件62/956,731的附錄A所描述的Polhemus Patriot系統具有可以放置在身體、頭枕、或二者上的自包含標記，並且不需要連續追蹤的視線。磁場藉由標記而產生，並輸出位置及定向資料，而不需要進行後期分析計算。精確及高品質的資料係以每個標記的50Hz的更新速率進行遞送。添加標記（例如，每個系統四個）。系統在表2中進一步描述。The Polhemus Patriot system, described in Appendix A of priority document 62/956,731, features self-contained markers that can be placed on the body, headrest, or both, and do not require line of sight for continuous tracking. A magnetic field is generated by the markers, outputting position and orientation data without the need for post-analysis calculations. Accurate, high-quality data is delivered at a 50 Hz update rate per marker. Markers are added (e.g., four per system). The system is further described in Table 2.
表2
在實施例中，雷射超音波系統（更特定為雷射超音波乳化系統）經配置而使得可以利用治療雷射束圖案將治療雷射束遞送至患者的一隻或兩隻眼睛，並且可以在患者的一隻或兩隻眼睛上執行超音波晶體乳化程序，而不需要患者或外科醫生相對於雷射超音波乳化系統的相對位置進行移動。In embodiments, a laser ultrasound system, and more particularly a laser phacoemulsification system, is configured to deliver a therapeutic laser beam to one or both eyes of a patient using a therapeutic laser beam pattern, and to perform a phacoemulsification procedure on one or both eyes of the patient without requiring movement of the patient or the surgeon relative to the laser phacoemulsification system.
在實施例中，相較於兩個系統並排放置或僅放置在共同殼體或共同艙位中的尺寸，本裝置（例如，整合超音波雷射裝置）的實施例的尺寸大幅減少，以在手術室中提供比單獨的雷射系統及超音波系統所需的總空間更小的佔地面積。此舉提供本發明之前的本領域的重大進步，認為完全整合的雷射超音波系統尚未在手術室中使用或尚未取得規範批准。此實施例的減少的尺寸在效率、功效、及二者上均提供相對於先前技術的數種改善。更換兩個系統的能力、消除在患者的治療期間移動患者、系統、或兩者的需要、消除將患者從手術室轉移到另一手術室的需要（在雷射系統與超音波系統位於不同房間的情況下）可以從這種較小尺寸的裝置實施例中獲得一些益處。此較小尺寸的裝置實施例亦提供在更多（例如，較小的）手術室中使用的能力，其中在手術室中工作的外科醫生及其他專業人員更容易移動。亦可以提供清理操作的優勢，並釋放空間以提供在手術室中安裝其他系統（例如，診斷裝置及顯微鏡）的能力。認為在本發明的實施例之前，該領域並未識別、解決、或解答與將超音波及雷射系統整合至具有此較小佔地面積及較小體積（高度、寬度、長度）的單一裝置相關聯的問題以及針對那些問題的解決方案，而在裝置之間沒有干擾，維持每一裝置按照預期操作的能力，並維持每一裝置所需的功效。In an embodiment, the size of an embodiment of the present device (e.g., an integrated ultrasound laser device) is significantly reduced compared to the size of the two systems placed side by side or simply placed in a common housing or common cabin, providing a smaller footprint in the operating room than the total space required for separate laser and ultrasound systems. This provides a significant advancement in the art, as fully integrated laser ultrasound systems were not considered for use in operating rooms or had not yet received regulatory approval. The reduced size of this embodiment provides several improvements in efficiency, efficacy, and both compared to the prior art. The ability to swap between two systems, eliminating the need to move the patient, the system, or both during treatment, and eliminating the need to transfer the patient from one operating room to another (in situations where the laser system and the ultrasound system are located in different rooms) can benefit from this smaller device embodiment. This smaller device embodiment also provides the ability to be used in more (e.g., smaller) operating rooms, where surgeons and other professionals working in the operating room can be more easily moved. It can also provide advantages in terms of cleaning operations and free up space to provide the ability to install other systems in the operating room (e.g., diagnostic equipment and microscopes). It is believed that prior to the embodiments of the present invention, the art had not identified, solved, or addressed the problems associated with integrating ultrasound and laser systems into a single device having such a small footprint and small size (height, width, length), and solutions to those problems, without interference between the devices, maintaining the ability of each device to operate as intended, and maintaining the desired efficacy of each device.
在這些系統的實施例中，從一個操作模式改變或切換至另一者的時間較佳為快速發生。因此，該裝置從一個模式改變至另一者（例如，從雷射模式改變至超音波晶體乳化模式）可以是約45秒至約10秒、約30秒至約5秒、少於一分鐘、少於30秒、少於15秒、少於10秒、少於5秒、及少於2秒。應理解，在改變裝置模式之後，並且在可以進行特定程序之前，可能需要額外的患者準備時間。In embodiments of these systems, the time to change or switch from one operating mode to another preferably occurs quickly. Thus, the device can change from one mode to another (e.g., from laser mode to ultrasonic phacoemulsification mode) in about 45 seconds to about 10 seconds, about 30 seconds to about 5 seconds, less than one minute, less than 30 seconds, less than 15 seconds, less than 10 seconds, less than 5 seconds, and less than 2 seconds. It should be understood that additional patient preparation time may be required after changing the device mode and before a particular procedure can be performed.
在這些雷射超音波系統（例如，整合超音波雷射裝置）的實施例中，該裝置（不包括患者床）的佔地面積係少於約50立方英呎（ft3）、少於約40立方英呎（ft3）、少於約35ft3、少於約30ft3、少於約25ft3、少於約200ft3、約31ft3、約28至約33ft3，以及這些的組合及變化，以及更大及更小的值。在實施例中，裝置的體積可以是可調整的，在此情況下，裝置的體積係為最小體積，除非另有明確說明。此裝置的高度可以是約45英吋（in）至約75in、約65in、約60in、約50in、約55in、少於60in、少於58in、約52in至約58in，以及這些的組合及變化，以及更大及更小的尺寸。（在臂、延伸部分、或部件可以移動至垂直位置或大約垂直位置以用於儲存或其他目的之實施例中，當該部件處於可操作配置或定位（例如通常為水平或大約水平）時，應測量高度。）在實施例中，裝置的高度可以是可調整的，在此情況下，裝置的高度係為最短高度，除非另有明確說明。此裝置的長度可以是約30in至約50in、約33in、約38in、約40in、少於約45in、少於40in、約34in至約38in、約36in，以及這些的組合及變體，以及更大及更小的尺寸。在實施例中，裝置的長度可以是可調整的（例如藉由可移動臂組件、托盤或托架），在此情況下，裝置的長度係為最短長度，除非另有明確說明。此裝置的寬度可以是約15in至約40in、約20in、約25in、約30in、少於約45in、少於約30in、約22in至約27in、約20in至約30in，以及這些的組合及變化，以及更大及更小的尺寸。在實施例中，裝置的寬度或長度可以是可調整的（例如藉由可移動臂組件、托盤或托架），在此情況下，裝置的寬度係為最短寬度，除非另有明確說明。這些裝置的實施例的裝置佔地面積（亦即，此裝置所佔用的地面空間的面積）可以是約400in2至約1300in2、約400in2至約600in2、約400in2至約500in2、約450in2至約700in2、約450in2、約500in2、約550in2、約600in2、少於約1200in2、少於約1100in2、少於約1000in2、約1000in2、約950in2、約900in2、約800in2、約850in2至約950in2，以及這些的組合及變化，以及更大及更小的尺寸。在實施例中，裝置的寬度、長度、及兩者可以是可調整的（例如藉由可移動臂組件、托盤或托架），在此情況下，裝置的佔地面積係為最小區域，除非另有明確說明。裝置的長度及寬度可以相同（例如，佔地面積係為正方形或圓形），或者可以不同（例如，佔地面積係為長方形或橢圓形）。應理解，可以預見佔地面積區域的其他形狀（例如，星形、「L」形、「H」形等）。In embodiments of these laser ultrasound systems (e.g., integrated ultrasound laser devices), the device (excluding the patient bed) has a footprint of less than about 50 cubic feet (ft3 ), less than about 40 cubic feet (ft3 ), less than about 35 ft3 , less than about 30 ft3 , less than about 25 ft3 , less than about 200 ft3 , about 31 ft3 , about 28 to about 33 ft3 , and combinations and variations thereof, as well as larger and smaller values. In embodiments, the volume of the device may be adjustable, in which case the volume of the device is the minimum volume unless expressly stated otherwise. The height of the device may be about 45 inches (in) to about 75 inches, about 65 inches, about 60 inches, about 50 inches, about 55 inches, less than 60 inches, less than 58 inches, about 52 inches to about 58 inches, and combinations and variations thereof, as well as larger and smaller sizes. (In embodiments where the arm, extension, or component can be moved to a vertical or approximately vertical position for storage or other purposes, the height should be measured when the component is in an operational configuration or position (e.g., generally horizontal or approximately horizontal).) In embodiments, the height of the device may be adjustable, in which case the height of the device is the shortest height unless expressly stated otherwise. The length of the device can be about 30 inches to about 50 inches, about 33 inches, about 38 inches, about 40 inches, less than about 45 inches, less than 40 inches, about 34 inches to about 38 inches, about 36 inches, and combinations and variations thereof, as well as larger and smaller sizes. In embodiments, the length of the device can be adjustable (e.g., via a movable arm assembly, tray, or bracket), in which case the length of the device is the shortest length unless otherwise expressly stated. The width of the device can be about 15 inches to about 40 inches, about 20 inches, about 25 inches, about 30 inches, less than about 45 inches, less than about 30 inches, about 22 inches to about 27 inches, about 20 inches to about 30 inches, and combinations and variations thereof, as well as larger and smaller sizes. In embodiments, the width or length of the device may be adjustable (e.g., by a movable arm assembly, tray, or bracket), in which case the width of the device is the shortest width unless expressly stated otherwise. Embodiments of these devices may have a device footprint (i.e., the area of floor space occupied by the device) of about 400 in2 to about 1300 in2 , about 400 in2 to about 600 in2 , about 400 in2 to about 500 in2 , about 450 in2 to about 700 in2 , about 450 in2 , about 500 in2 , about 550 in2 , about 600 in2 , less than about 1200in 2 , less than about 1100 in2 , less than about 1000in 2 , about 1000in 2 , about 950 in2 , about 900 in2 , about 800 in2 , about 850 in2 to about 950 in2 , and combinations and variations thereof, as well as larger and smaller sizes. In embodiments, the width, length, or both of the device may be adjustable (e.g., via a movable arm assembly, tray, or bracket), in which case the footprint of the device is the minimum area unless otherwise expressly stated. The length and width of the device may be the same (e.g., a square or circular footprint) or different (e.g., a rectangular or elliptical footprint). It should be understood that other shapes of footprints are envisioned (e.g., star-shaped, "L"-shaped, "H"-shaped, etc.).
典型地，超音波晶體乳化裝置具有約20乘以約25in的佔地面積，而因此具有約500in2的佔地面積（亦即，「標準超音波乳化佔地面積區域」）。因此，超音波乳化雷射整合系統的實施例的佔地面積區域可以是500in2的典型超音波乳化佔地面積區域的約70％及更小、約80％及更小、約90％及更小、約100％及更小、約110％及更小、約120％及更小、約130％及更小、約140％及更小、約150％及更小。藉由在僅比一個裝置稍大的區域中具有兩個裝置（從而具有兩個治療功能）的本發明的實施例所實現的此協同作用，在手術室及醫療辦公室中、針對工作流程、可以用於患者護理的房間（例如，現在可以使用較小的房間）、患者及工作人員的舒適度、及功效等提供顯著益處及優勢。Typically, a phacoemulsification device has a footprint of about 20 by about 25 inches, and thus has a footprint of about 500in² (i.e., a "standard phacoemulsification footprint"). Accordingly, embodiments of an integrated phacoemulsification-laser system can have a footprint that is about 70% or less, about 80% or less, about 90% or less, about 100% or less, about 110% or less, about 120% or less, about 130% or less, about140 % or less, or about 150% or less of the typical phacoemulsification footprint of 500 in². This synergy achieved by embodiments of the present invention, by having two devices (and therefore two treatment functions) in an area only slightly larger than one device, provides significant benefits and advantages in operating rooms and medical offices with respect to workflow, the rooms that can be used for patient care (e.g., smaller rooms can now be used), patient and staff comfort, and efficacy.
此外，即使在超音波晶體乳化系統小於典型的佔地面積的情況下，本發明的組合的雷射超音波系統可以配置成比單獨的雷射以及這種較小的佔地面積的超音波系統佔用更少的空間。Furthermore, even in the case of a smaller than typical footprint for an ultrasonic phacoemulsification system, the combined laser and ultrasound system of the present invention can be configured to occupy less space than separate laser and ultrasound systems of such smaller footprints.
在這些系統的實施例中，藉由使用客製化托盤以及托持及定位用於雷射治療程序、雷射診斷程序、超音波晶體乳化程序、及水晶體植入以及任何屈光程序的各種外科工具、儀器、工具包、及裝備的裝置來實現進一步的協同作用。這些客製化手術托盤及工具包可以是可拆卸地固定至裝置殼體（或藉由裝置殼體托持或在裝置殼體中）的單次使用的拋棄式用品，並且可以是用於托持拋棄式或可重複使用的工具及儀器的整合托盤，以及這些的組合及變化。In embodiments of these systems, further synergy is achieved through the use of customized trays and devices that hold and position various surgical tools, instruments, kits, and equipment used in laser therapeutic procedures, laser diagnostic procedures, ultrasonic phacoemulsification procedures, and lens implants, as well as any refractive procedure. These customized surgical trays and kits can be single-use, disposable items that are removably secured to (or held by or within) the device housing, and can be integrated trays for holding disposable or reusable tools and instruments, as well as combinations and variations thereof.
轉至第1圖，圖示雷射超音波系統100的實施例的透視圖。系統100係為具有第一殼體101與第二殼體102的裝置。殼體101及102包含功率部件、控制部件、操作部件、分析預測及診斷裝置、位置決定及定位裝備、雷射束產生部件、及超音波產生部件。在較佳實施例中，超音波產生部件係為超音波晶體乳化系統的部件，而雷射束產生部件提供具有約10ps、5ps、2ps、及更短的脈衝長度的雷射束。Turning to FIG. 1 , a perspective view of an embodiment of a laser ultrasound system 100 is shown. System 100 is a device having a first housing 101 and a second housing 102. Housings 101 and 102 contain power components, control components, operating components, analysis, prediction, and diagnostic equipment, position determination and positioning equipment, a laser beam generating component, and an ultrasound generating component. In a preferred embodiment, the ultrasound generating component is a component of an ultrasound phacoemulsification system, and the laser beam generating component provides a laser beam having a pulse length of approximately 10 ps, 5 ps, 2 ps, or less.
這些部件可能由於以下原因而全部或部分地分佈在兩個殼體101、102之間：為了最佳化空間，為了避免部件之間的干擾，為了管理熱及振動，以及為了提供系統100的更有效控制及操作。兩個殼體101、102可以是在相同的底座或框架150上的獨立殼體，可以在其間具有通訊、控制、功率、光學、及其他連接，可以是單一相同的殼體，可以細分或劃分成第三或第四等殼體或子殼體，以及這些的組合及變化。These components may be distributed, in whole or in part, between the two housings 101, 102 for the following reasons: to optimize space, to avoid interference between components, to manage heat and vibration, and to provide more efficient control and operation of the system 100. The two housings 101, 102 may be separate housings on the same base or frame 150, may have communications, control, power, optical, and other connections therebetween, may be a single identical housing, may be subdivided or divided into third or fourth housings or sub-housings, and combinations and variations thereof.
存在將殼體102與殼體106連接的光學導管105。殼體106包含用於治療雷射束的掃描裝置及束成形光學裝置，其中掃描裝置、光學裝置、及兩者均可以用於監視及診斷雷射束及光學路徑。應理解，在實施例中，殼體106的這些部件可以全部或部分地位於另一殼體102、101中的一個，並且同樣地，來自殼體102、101的部件可以位於殼體106中。殼體106可以與殼體102、101整合，或者可以是殼體102、101的一部分。殼體106可以細分或劃分成一或更多個殼體或子殼體，以及這些的組合及變化。在當前較佳實施例中，殼體106包含並隔離掃描器及束成形光學裝置。掃描器及束成形光學裝置或可能包含在殼體106中的其他部件係與系統100的控制器及操作系統進行控制通訊。控制通訊係意指將與裝置的操作有關的資訊發送至裝置以及從裝置發送，將藉由裝置取得或接收的資料發送至裝置以及從裝置發送，以及將控制資訊、指令、或命令發送至裝置以及從裝置發送，以及這些和其他資料及資訊的組合及變化。裝置可以彼此直接進行控制通訊，或者可以彼此間接進行控制通訊（例如藉由與中心（例如，可能亦具有控制能力的系統100控制器、監視器109）進行控制通訊），以及這些的組合及變化。這些裝置亦可以彼此直接及間接進行控制通訊。There is an optical conduit 105 connecting housing 102 to housing 106. Housing 106 contains a scanning device and beam-shaping optics for the therapeutic laser beam, wherein the scanning device, the optics, and both can be used to monitor and diagnose the laser beam and the optical path. It should be understood that in embodiments, these components of housing 106 can be located in whole or in part in one of the other housings 102, 101, and similarly, components from housings 102, 101 can be located in housing 106. Housing 106 can be integral with housings 102, 101, or can be part of housings 102, 101. Housing 106 can be subdivided or divided into one or more housings or subhousings, as well as combinations and variations thereof. In the presently preferred embodiment, housing 106 contains and isolates a scanner and beam-shaping optics. The scanner and beam-shaping optics, or other components that may be included in housing 106, are in control communication with the controller and operating system of system 100. Control communication refers to the transmission of information related to the operation of the device to and from the device, the transmission of data acquired or received by the device to and from the device, and the transmission of control information, instructions, or commands to and from the device, as well as combinations and variations of these and other data and information. Devices may be in direct control communication with one another, or may be in indirect control communication with one another (e.g., via control communication with a center (e.g., a system 100 controller, monitor 109, which may also have control capabilities), as well as combinations and variations of these. Devices may also be in direct and indirect control communication with one another.
光學導管105可以是光管路（例如，具有內部反射表面的中空管或通道，而使得雷射束發射通過中空管內的自由空間，而中空管內的自由空間可以具有部分真空，具有環境中的空氣，包含惰性氣體，及這些的組合及變化）、鉸接式光管路、伸縮式光管路、柔性光管路、光纖、一或更多個光纖、中空導管、束導引器，以及這些及其他雷射束傳輸結構的組合及變化。The optical conduit 105 can be a light pipe (e.g., a hollow tube or channel with an internal reflective surface such that the laser beam is emitted through free space within the hollow tube, wherein the free space within the hollow tube can have a partial vacuum, have ambient air, include an inert gas, and combinations and variations of these), an articulated light pipe, a telescoping light pipe, a flexible light pipe, an optical fiber, one or more optical fibers, a hollow conduit, a beam guide, and combinations and variations of these and other laser beam delivery structures.
殼體106具有臂107，臂107可以沿著箭頭107a及107b的方向移動、延伸、收縮、及這些的組合及變化。臂107及殼體106藉由升降器裝置110沿著垂直方向移動，如箭頭107a所示。臂107具有用於決定眼睛的形狀及位置以及眼睛內的結構的組件或裝置108。臂107的近端（亦即，沿著雷射束路徑最遠的端部，而因此距離雷射束源最遠，並且位於裝置108下方）具有患者介面裝置（PID）（在圖式中未圖示）。臂107具有監視器109，監視器109在多關節臂上沿著箭頭109a的方向移動。監視器可以提供資訊（例如，程序、系統狀況、雷射狀態、超音波狀態、白內障密度、超音波設定、雷射圖案設定），並且可以接收外科醫生的輸入及指令。監視器係與系統100控制系統進行控制通訊，監視器亦可以包含系統100控制系統的一部分或全部。監視器透過系統100控制系統、透過監視器109、及這些的組合及變化直接與雷射控制系統及超音波控制系統進行控制通訊。監視器及其關節臂可以位於系統100中的其他結構上，亦可以單獨設置。可以使用一個、兩個、及額外的監視器。監視器可以具有3D查看或顯示功能。Housing 106 has an arm 107 that can move, extend, retract, and any combination or variation of these in the directions of arrows 107a and 107b. Arm 107 and housing 106 are moved vertically, as indicated by arrow 107a, by an elevator device 110. Arm 107 has components or devices 108 for determining the shape and position of the eye and structures within the eye. The proximal end of arm 107 (i.e., the end furthest along the laser beam path and therefore farthest from the laser beam source, and located below device 108) has a patient interface device (PID) (not shown in the figures). Arm 107 has a monitor 109 that moves on the multi-jointed arm in the direction of arrow 109a. The monitor can provide information (e.g., procedures, system status, laser status, ultrasound status, cataract density, ultrasound settings, laser pattern settings) and can receive input and instructions from the surgeon. The monitor is in control communication with the system 100 control system, and the monitor can also include part or all of the system 100 control system. The monitor is in control communication directly with the laser control system and the ultrasound control system through the system 100 control system, through the monitor 109, and combinations and variations of these. The monitor and its articulated arm can be located on other structures in the system 100 or can be set separately. One, two, or additional monitors can be used. The monitor can have 3D viewing or display capabilities.
臂107形成或包含雷射束傳輸結構（例如，中空管），以提供用於雷射束的傳送的自由空間。在實施例中，臂107可以包含自由空間中的光束路徑，或者用於將雷射束發送至例如掃描器的光纖，光纖位於管的近端而不是遠端（亦即，靠近殼體106的端部）。臂107亦可以是或包含描述用於光學導管105的類型的雷射束傳輸結構。管亦可以包含光學裝置。在第1圖的實施例中，臂107包含非準直的雷射束，而因此臂107可以指稱為包含非準直的雷射束及雷射束路徑，換言之，臂107沿著雷射束路徑包含、圍繞、或容納「非準直空間」。臂107可以容納或圍繞準直空間，準直空間係為雷射束路徑上的雷射束進行準直的空間。其可以容納包含光學裝置的空間。其可以容納準直及非準直的空間。實施例中的臂107可以從遠端樞轉、旋轉、伸縮、鉸接、及這些的組合及變化。臂107中的雷射束路徑的近端包含鏡或光學裝置，以將雷射束引導通過PID，並到達及進入患者的眼睛。Arm 107 forms or includes a laser beam transmission structure (e.g., a hollow tube) that provides free space for the transmission of the laser beam. In embodiments, arm 107 may include a beam path in free space, or an optical fiber for transmitting the laser beam to, for example, a scanner, with the optical fiber located at the proximal end of the tube rather than the distal end (i.e., near the end of housing 106). Arm 107 may also be or include a laser beam transmission structure of the type described for optical conduit 105. The tube may also include optical devices. In the embodiment of FIG. 1 , arm 107 includes a non-collimated laser beam, and thus arm 107 may be referred to as including the non-collimated laser beam and the laser beam path. In other words, arm 107 includes, surrounds, or accommodates "non-collimated space" along the laser beam path. Arm 107 can contain or surround a collimation space, which is the space where the laser beam is collimated within the laser beam path. It can also contain space containing optical devices. It can accommodate both collimated and non-collimated spaces. In embodiments, arm 107 can pivot, rotate, extend, articulate, or any combination or variation of these at the distal end. The proximal end of the laser beam path within arm 107 contains a mirror or optical device to guide the laser beam through the PID and into the patient's eye.
系統100具有用於將電纜及管線連接至超音波、抽吸、其他工具、及這些的組合及變化的二個埠103、104。在實施例中，這些埠經配置以連接至超音波晶體乳化工具或超音波乳化盒系統。埠103及104係圖示於殼體102上，應理解，可以在殼體101上，或者在系統上的其他位置上，或者可以是已經插入系統100中的超音波乳化盒的一部分。System 100 has two ports 103 and 104 for connecting cables and tubing to ultrasound, suction, other tools, and combinations and variations thereof. In one embodiment, these ports are configured to connect to a phacoemulsification tool or a phacoemulsification cartridge system. Ports 103 and 104 are shown on housing 102, but it should be understood that they can be on housing 101, elsewhere on the system, or part of a phacoemulsification cartridge already inserted into system 100.
在實施例中，雷射系統具有外部、內部、或兩者的冷卻。例如，冷卻流體流入及流出雷射殼體。In some embodiments, the laser system has external, internal, or both cooling, for example, a cooling fluid flows into and out of the laser housing.
系統100具有箭頭120所示的高度，系統具有箭頭121所示的長度以及箭頭122所示的寬度。寬度及長度定義系統100的佔地面積，而藉由高度120、長度121、及寬度122定義體積。 治療雷射及系統：一般System 100 has a height indicated by arrow 120, a length indicated by arrow 121, and a width indicated by arrow 122. The width and length define the footprint of system 100, while height 120, length 121, and width 122 define the volume.Therapeutic Lasers and Systems: General
經配置以提供對於治療眼睛、其結構、及鄰近組織及其狀況有用、安全、及有效的雷射束的任何雷射都可以用於提供治療雷射束。可以使用可調諧雷射、可調整雷射、及這些雷射的組合及變化（例如，可以改變脈衝寬度，可以改變脈衝速率，可以改變功率，以及可以改變波長）。可以使用一種以上的治療雷射。治療雷射可以是脈衝雷射（例如，飛秒雷射或皮秒雷射，以及更長或更短的脈衝）、連續雷射、及其組合。Any laser configured to provide a laser beam that is useful, safe, and effective for treating the eye, its structures, and adjacent tissues and conditions thereof can be used to provide the therapeutic laser beam. Tunable lasers, adjustable lasers, and combinations and variations of these lasers (e.g., variable pulse width, variable pulse rate, variable power, and variable wavelength) can be used. More than one type of therapeutic laser can be used. The therapeutic laser can be a pulsed laser (e.g., a femtosecond laser or a picosecond laser, as well as longer or shorter pulses), a continuous laser, or combinations thereof.
治療雷射可以具有IR光譜、UV光譜、及其他波長中的波長。治療雷射的波長可以是約300nm至約2500nm、約1000奈米（nm）至約1300nm、1020nm、約1020nm、1030nm、約1030nm、1040nm、約1040nm、1050nm、約1050nm、及約1020至約1050nm，以及這些及其他波長的組合及變化。The therapeutic laser can have a wavelength in the IR spectrum, the UV spectrum, and other wavelengths. The therapeutic laser can have a wavelength of about 300 nm to about 2500 nm, about 1000 nanometers (nm) to about 1300 nm, 1020 nm, about 1020 nm, 1030 nm, about 1030 nm, 1040 nm, about 1040 nm, 1050 nm, about 1050 nm, and about 1020 to about 1050 nm, as well as combinations and variations of these and other wavelengths.
治療雷射的脈衝持續時間可以是約1fs至約100ps、約200fs至約500ps、約300fs至約100ps、約300fs至約10ps、約300fs至約2000fs，以及這些波長與更長及更短的持續時間的組合及變化。系統的一或更多個「短脈衝持續時間」治療雷射的脈衝寬度可以是300fs、約300fs、350fs、約350fs、400fs、約450fs、500fs、約500fs、300fs至約600fs，以及這些的組合及變化。系統的一或更多個「長脈衝持續時間」治療雷射的脈衝持續時間可以是1000fs、約1000fs、1200fs、約1200fs、1300fs、約1300fs、1500fs、約1500fs、約1200fs至約1600fs，以及這些的組合及變化。The pulse duration of the therapeutic laser can be about 1 fs to about 100 ps, about 200 fs to about 500 ps, about 300 fs to about 100 ps, about 300 fs to about 10 ps, about 300 fs to about 2000 fs, and combinations and variations of these wavelengths with longer and shorter durations. The pulse width of one or more "short pulse duration" therapeutic lasers of the system can be 300 fs, about 300 fs, 350 fs, about 350 fs, 400 fs, about 450 fs, 500 fs, about 500 fs, 300 fs to about 600 fs, and combinations and variations of these. The pulse duration of one or more of the "long pulse duration" treatment lasers of the system can be 1000 fs, about 1000 fs, 1200 fs, about 1200 fs, 1300 fs, about 1300 fs, 1500 fs, about 1500 fs, about 1200 fs to about 1600 fs, and combinations and variations thereof.
治療雷射束的脈衝重複率可以是約50千赫茲（kHz）至約5兆赫茲（Mhz）、約50kHz至約2Mhz、約50kHz至約1Mhz、約50kHz至約750kHz、約100kHz至約200kHz、約150kHz至約350kHz、約100kHz、約150kHz、約200kHz、約300kHz，以及這些與更大及更小的速率的變化及組合。The pulse repetition rate of the therapeutic laser beam can be about 50 kilohertz (kHz) to about 5 megahertz (Mhz), about 50 kHz to about 2 MHz, about 50 kHz to about 1 MHz, about 50 kHz to about 750 kHz, about 100 kHz to about 200 kHz, about 150 kHz to about 350 kHz, about 100 kHz, about 150 kHz, about 200 kHz, about 300 kHz, and variations and combinations of these and larger and smaller rates.
治療雷射束的指定脈衝重複率處的平均輸出功率可以是約1瓦（W）至約8W、約2.5W至約5W、約3W至約4.5W、3W至5W、少於6W、少於5W、發生雷射引起的光學崩塌（LIOB）、光致破裂、或兩者的任何功率，以及這些與更低及更高的功率的組合及變化。The average output power of the therapeutic laser beam at a specified pulse repetition rate can be from about 1 watt (W) to about 8 W, from about 2.5 W to about 5 W, from about 3 W to about 4.5 W, from 3 W to 5 W, less than 6 W, less than 5 W, any power at which laser-induced optical collapse (LIOB), photodisruption, or both occur, and combinations and variations of these with lower and higher powers.
這些系統的實施例亦可以執行子閾值治療、診斷、及這些的組合及變化。因此，可以利用低於發生LIOB的點的功率或方式將治療雷射束遞送至眼睛。可以利用低於發生光致破裂的點的功率或方式將治療雷射束遞送至眼睛。因此，在本程序的實施例中，可以執行子閾值雷射程序，可以執行引起光致破裂的雷射程序，可以執行超音波晶體乳化，以及可以執行這些程序中的一些或全部的組合及變化，而不需要移動患者或裝置的位置。Embodiments of these systems can also perform subthreshold treatments, diagnostics, and combinations and variations of these. Thus, a therapeutic laser beam can be delivered to the eye at a power or in a manner below the point at which LIOB occurs. A therapeutic laser beam can be delivered to the eye at a power or in a manner below the point at which photodisruption occurs. Thus, in embodiments of the present procedures, subthreshold laser procedures can be performed, laser procedures that cause photodisruption can be performed, ultrasonic phacoemulsification can be performed, and combinations and variations of some or all of these procedures can be performed without requiring repositioning of the patient or the device.
治療雷射束的脈衝能量可以是約1奈焦耳（nJ）至約2毫焦耳（mJ）、約1nJ至約1mJ、約2微焦耳（µJ）至約70μJ、約5μJ至約45μJ、約2μJ至約35μJ、約10μJ至約30μJ、少於45μJ、少於35μJ、發生光致破裂、LIOB、或兩者的任何脈衝能量，以及這些與更低及更高的能量的組合及變化。The pulse energy of the therapeutic laser beam can be about 1 nanojoule (nJ) to about 2 millijoules (mJ), about 1 nJ to about 1 mJ, about 2 microjoules (µJ) to about 70 μJ, about 5 μJ to about 45 μJ, about 2 μJ to about 35 μJ, about 10 μJ to about 30 μJ, less than 45 μJ, less than 35 μJ, any pulse energy that causes photodisruption, LIOB, or both, and combinations and variations of these with lower and higher energies.
本系統的治療雷射束可以具有一或更多個上述束特徵（例如，波長、持續時間、重複率、功率、脈衝能量，以及這些的組合及變化）。The therapeutic laser beam of the present system may have one or more of the above-described beam characteristics (e.g., wavelength, duration, repetition rate, power, pulse energy, and combinations and variations of these).
可以將產生1030nm波長的超短雷射脈衝的Yb：YAG雷射作為治療雷射。通常，治療雷射所提供的束的波長可以發送通過角膜、水狀液、及水晶體。束可以具有短脈衝長度而與能量及束尺寸一起產生目標眼組織（例如，角膜、角膜緣、水晶體囊、水晶體、白內障組織、混濁組織、及其他組織）的光致破裂、LIOB、或兩者。因此，本文所使用的術語「雷射射擊」或「射擊」係指稱遞送至其自身或與其他脈衝組合（例如，LIOB）產生治療效果的位置的雷射束脈衝。本文所使用的術語「光致破裂」基本上係指稱藉由雷射將物質轉化成氣體。在實施例中，可以採用約300nm至2500nm的波長。可以採用約1飛秒至100皮秒的脈衝寬度。可以採用約1奈焦耳至1毫焦耳的能量。脈衝速率（亦指稱為脈衝重複頻率（PRF）與每秒脈衝（以赫茲為單位））可以是約1kHz至幾GHz。通常，在商業雷射裝置中，較低的脈衝速率係對應於較高的脈衝能量。取決於脈衝長度、能量密度、及其他因素，可以使用多種類型的雷射來產生治療效果（例如，造成眼組織的光致破裂、LIOB、或兩者）。因此，此類雷射器的實例包括：Delmar Photonics Inc. Trestles-20，其為鈦藍寶石（Ti：Sapphire）振盪器，波長範圍係為780至840nm，少於20飛秒的脈衝寬度，約100MHz的PRF，具有2.5奈焦耳；Clark CPA-2161，其為放大的鈦藍寶石，波長係為775nm，少於150飛秒的脈衝寬度，約3KHz的PRF，具有850微焦耳；IMRA FCPA（光纖啁啾脈衝放大）μjewel D系列的D-400-HR，其為Yb：光纖振盪器/放大器，波長係為1045nm，少於1皮秒的脈衝寬度，約5MHz的PRF，具有100奈焦耳；Coherent Staccato，其為YB：Yag，波長係為1030nm，約1.5皮秒的脈衝寬度，約80KHz的PRF，具有30微焦耳；Coherent Rapid，其為YB：Yag，波長係為1030nm，約1.5皮秒的脈衝寬度，可以包括一或更多個放大器，以在25kHz至650kHz之間的PRF處實現約2.5至10瓦的平均功率，亦包括可以閘通兩個單獨的50MHz脈衝序列的多脈衝能力；以及IMRA FCPA（光纖啁啾脈衝放大）pJewel D系列的D-400-NC，其為Yb：光纖振盪器/放大器，波長係為1045nm，少於100皮秒的脈衝寬度，約200KHz的PRF，具有4微焦耳。這些及其他類似的雷射可以作為治療雷射，並用於產生治療雷射束。A Yb:YAG laser, which produces ultrashort laser pulses at a wavelength of 1030 nm, can be used as a therapeutic laser. Typically, the wavelength of the beam provided by a therapeutic laser can be delivered through the cornea, aqueous humor, and lens. The beam can have a short pulse length that, along with the energy and beam size, produces photodisruption, LIOB, or both, of the target ocular tissue (e.g., the cornea, limbus, lens capsule, lens, cataractous tissue, opacified tissue, and other tissues). Therefore, as used herein, the term "laser shot" or "shot" refers to a laser beam pulse delivered to a location that, by itself or in combination with other pulses (e.g., LIOB), produces a therapeutic effect. The term "photodisruption," as used herein, generally refers to the conversion of a substance into a gas by a laser. In embodiments, a wavelength of approximately 300 nm to 2500 nm may be used. A pulse width of approximately 1 femtosecond to 100 picoseconds may be used. An energy of approximately 1 nanojoule to 1 millijoule may be used. The pulse rate (also referred to as pulse repetition frequency (PRF) and pulses per second (in Hertz)) may be approximately 1 kHz to several GHz. Typically, in commercial laser devices, lower pulse rates correspond to higher pulse energies. Depending on pulse length, energy density, and other factors, a variety of laser types can be used to produce a therapeutic effect (e.g., causing photodisruption of ocular tissue, LIOB, or both). Examples of such lasers include the Delmar Photonics Inc. Trestles-20, a titanium sapphire (Ti:Sapphire) oscillator with a wavelength range of 780 to 840 nm, a pulse width of less than 20 femtoseconds, a PRF of approximately 100 MHz, and 2.5 nanojoules; the Clark CPA-2161, an amplified titanium sapphire with a wavelength of 775 nm, a pulse width of less than 150 femtoseconds, a PRF of approximately 3 kHz, and 850 microjoules; and the IMRA FCPA (Fiber Chirped Pulse Amplification) μjewel. The D-Series includes the D-400-HR, a Yb:Yag fiber oscillator/amplifier with a wavelength of 1045 nm, a pulse width of less than 1 picosecond, a PRF of approximately 5 MHz, and 100 nanojoules; the Coherent Staccato, a Yb:Yag fiber oscillator/amplifier with a wavelength of 1030 nm, a pulse width of approximately 1.5 picoseconds, a PRF of approximately 80 kHz, and 30 microjoules; and the Coherent Rapid, a Yb:Yag fiber oscillator with a wavelength of 1030 nm and a pulse width of approximately 1.5 picoseconds. The amplifiers can include one or more amplifiers to achieve average power of approximately 2.5 to 10 watts at a PRF between 25 kHz and 650 kHz, and include multi-pulse capability that can gate two separate 50 MHz pulse trains; and the IMRA. The D-400-NC, a Yb:Yb fiber oscillator/amplifier from the pJewel D series (FCPA), features a 1045nm wavelength, a pulse width of less than 100 picoseconds, a PRF of approximately 200 kHz, and a power factor of 4 microjoules. These and similar lasers can be used as therapeutic lasers to generate therapeutic laser beams.
在美國專利申請公開號2016/0302971、2015/0105759、2014/0378955以及美國專利號8,262,646及8,708,491中揭示及教示用於在眼睛上執行雷射操作的雷射系統、方法、及設備的實施例，其每一者的全部揭示藉由引用併入本文。 雷射束遞送：一般Embodiments of laser systems, methods, and apparatus for performing laser operations on the eye are disclosed and taught in U.S. Patent Application Publication Nos. 2016/0302971, 2015/0105759, 2014/0378955, and U.S. Patent Nos. 8,262,646 and 8,708,491, the entire disclosures of each of which are incorporated herein by reference.Laser Beam Delivery: General
通常，用於將治療雷射束遞送至眼睛的自然水晶體的光學裝置的實施例應該能夠利用精確的預先決定的圖案在x、y、及z維度上向自然水晶體提供一系列射擊。光學裝置亦應提供預先決定的束斑尺寸，以利用到達自然水晶體或其他目標組織的雷射能量來造成光致破裂、LIOB、或兩者。因此，光學裝置可以包括但不限於：xy掃描器；z聚焦裝置；及聚焦光學裝置。聚焦光學裝置可以是習知聚焦光學裝置、平場光學裝置、遠心光學裝置、及這些的組合及變化，每一者都具有對應的電腦控制的聚焦，而實現x、y、z維度上的校準。舉例而言，xy掃描器可以是具有位置偵測器反饋的一對閉合迴路檢流計。此類xy掃描器的實例係為Cambridge TechnologyInc.的6450型、SCANLAB hurrySCAN、及AGRES Rhino掃描器。這種z聚焦裝置的實例係為Phsyik International Peizo聚焦單元ESee型的Z聚焦控制以及SCANLAB varrioSCAN。 雷射控制系統：一般Generally, embodiments of optical devices for delivering a therapeutic laser beam to the natural lens of the eye should be capable of providing a series of shots to the natural lens in the x, y, and z dimensions using a precise predetermined pattern. The optical device should also provide a predetermined beam spot size to utilize the laser energy reaching the natural lens or other target tissue to cause photodisruption, LIOB, or both. Thus, the optical device may include, but is not limited to: an xy scanner; a z focus device; and focusing optics. The focusing optics may be learned focusing optics, flat-field optics, telecentric optics, and combinations and variations of these, each with corresponding computer-controlled focusing to achieve calibration in the x, y, and z dimensions. For example, an xy scanner can be a pair of closed-loop galvanometers with position detector feedback. Examples of such xy scanners are the Cambridge Technology Inc. Model 6450, the SCANLAB hurrySCAN, and the AGRES Rhino scanner. Examples of such z-focusing devices are the Phsyik International Peizo Focusing Unit Model ESee Z Focus Control and the SCANLAB varrioSCAN.Laser Control Systems: General
通常，用於遞送治療雷射束的控制系統的實施例可以是能夠選擇及控制xyz掃描參數及雷射擊發等的任何電腦、控制器、軟體硬體、及這些的組合及變形。這些部件通常可以至少部分相關聯於與xy掃描器、z聚焦裝置、雷射、及這些的組合及變化對接的電路板。雷射控制系統可以包含引導雷射通過一或更多個雷射射擊圖案的程式。雷射控制系統亦具有與系統控制系統整合的進一步能力，以及與具有超音波控制及監視器或控制面板的整合系統一起使用或一起工作的功能。系統控制器、雷射控制器、超音波控制器、及這些的組合及變化亦可以控制系統的其他部件，以及維護資料、取得資料、分析資料及圖像、準備及建議表格及治療方法、及執行計算。控制系統可以包含引導雷射通過一或更多個雷射射擊圖案的程式。 位置及形狀決定：一般Generally, embodiments of a control system for delivering a therapeutic laser beam can be any computer, controller, software, hardware, and combinations and variations thereof that is capable of selecting and controlling xyz scanning parameters and laser firing, etc. These components can generally be associated, at least in part, with a circuit board that interfaces with an xy scanner, a z focuser, a laser, and combinations and variations thereof. The laser control system can include programming for directing the laser through one or more laser shot patterns. The laser control system also has the further capability of being integrated with a system control system and being used or operating with an integrated system having ultrasonic control and a monitor or control panel. The system controller, laser controller, ultrasound controller, and combinations and variations of these may also control other components of the system, as well as maintain data, acquire data, analyze data and images, prepare and recommend treatment plans and regimens, and perform calculations. The control system may include programming for directing the laser through one or more laser shot patterns.Position and Shape Determination: General
通常，在實施例中，用於決定眼睛的形狀擊位置以及眼睛內的結構的組件或裝置可以是光學同調斷層掃描（OCT）、具有單一可移動相機的沙姆裝置、多個固定相機、這些的組合及變化、及用於進行此類決定的其他類型的裝置。在實施例中，此裝置決定水晶體的部分（或眼睛或與眼睛相鄰的組織的其他結構）與雷射（例如，光學裝置頭）的相對距離。在實施例中，此距離藉由例如PID維持恆定。在實施例中，此裝置決定相對於所有三個維度上的雷射遞送圖案的掃描坐標的水晶體及其他結構的位置。這可以藉由幾種方法及設備來實現。舉例而言，可以藉由經由同心標號的相機系統及顯示器觀察水晶體或者藉由使用直接觀察光學裝置然後手動將患者的眼睛定位到已知中心來實現水晶體的xy定心。然後，可以藉由使用光學三角測量或雷射及ccd系統的範圍測量裝置（例如，Micro-Epsilon opto NCDT1401雷射感測器、Aculux Laser Ranger LR2-22、及這些的組合及變化）來決定z位置。亦可以使用3維觀看及測量設備來決定水晶體的x、y、及z位置。舉例而言，可以使用Vision Engineering的Hawk3軸非接觸式測量系統來進行這些決定。可以用於決定水晶體的位置的設備的進一步實例係為3維測量設備。此設備包含可以觀看參考物與自然水晶體的一或更多個相機，並且亦包括用於照亮自然水晶體的光源。這樣的光源可以是結構化的光源（例如，經設計以基於幾何形狀來產生3維資訊的狹縫照明）。可以在眼睛周圍定位另一個、兩個、三個、四個、或更多個光源，並利用電子方式啟動，以在多個平面切片中提供眼睛（更特定維角膜及水晶體）的多個視圖、平面圖像，然後可以整合以提供有關這些結構的相對於雷射系統的定位及位置資訊的資料。在美國專利公開號及專利號2018/0085256、2016/0302971、2015/0105759、2012/0330290、2016/0030244、9,180,051、及8,708,491中揭示及教示用於決定相對於雷射、雷射射擊圖案、及雷射束的眼睛及結構的形狀及位置的組件、方法、裝置的實例，其每一者的全部揭示內容藉由引用併入本文。在美國專利公開號2015/0105759中教示及揭示用於決定眼睛的位置的愛爾蘭配準裝置，其全部揭示內容藉由引用併入本文。 患者介面：一般Generally, in embodiments, the assembly or device used to determine the shape and position of the eye and structures within the eye can be optical coherence tomography (OCT), a Sham device with a single movable camera, multiple fixed cameras, combinations and variations of these, or other types of devices used to make such determinations. In embodiments, the device determines the relative distance between a portion of the lens (or other structure of the eye or tissue adjacent to the eye) and a laser (e.g., an optical device head). In embodiments, this distance is maintained constant by, for example, a PID. In embodiments, the device determines the position of the lens and other structures relative to the scan coordinates of a laser-delivered pattern in all three dimensions. This can be achieved using a variety of methods and devices. For example, xy centering of the lens can be achieved by viewing the lens through a concentrically labeled camera system and display, or by using direct viewing optics and then manually positioning the patient's eye to a known center. The z position can then be determined by using a range measurement device that uses optical triangulation or a laser and CCD system (e.g., the Micro-Epsilon Opto NCDT1401 laser sensor, the Aculux Laser Ranger LR2-22, and combinations and variations of these). A 3D viewing and measurement device can also be used to determine the x, y, and z positions of the lens. For example, the Hawk 3-axis non-contact measurement system from Vision Engineering can be used to make these determinations. A further example of a device that can be used to determine the position of the lens is a 3D measurement device. The apparatus includes one or more cameras capable of viewing a reference object and a natural lens, and also includes a light source for illuminating the natural lens. Such a light source may be a structured light source (e.g., slit illumination designed to generate 3D information based on geometric shapes). Another, two, three, four, or more light sources may be positioned around the eye and electronically activated to provide multiple views, planar images of the eye (more specifically, the cornea and lens) in multiple planar slices, which may then be integrated to provide data regarding the location and position information of these structures relative to the laser system. Examples of assemblies, methods, and devices for determining the shape and position of an eye and structures relative to a laser, laser shot pattern, and laser beam are disclosed and taught in U.S. Patent Publication Nos. 2018/0085256, 2016/0302971, 2015/0105759, 2012/0330290, 2016/0030244, 9,180,051, and 8,708,491, the entire disclosures of each of which are incorporated herein by reference. An Irish registration device for determining the position of an eye is taught and disclosed in U.S. Patent Publication No. 2015/0105759, the entire disclosure of which is incorporated herein by reference.Patient Interface: General
這些系統的實施例的進一步部件可以是雷射患者介面或PID。應理解，PID的全部或一些通常不是系統的一部分，而是較佳為在雷射程序之前或在設定雷射程序時針對每一患者添加到系統中的單次使用的裝置（例如，拋棄式）。在實施例中，此介面在程序期間提供自然水晶體與雷射之間的x、y、z位置保持固定，程序包括決定xyz位置的測量步驟以及將雷射利用射擊圖案遞送至水晶體的遞送步驟。介面裝置可以包含光學透明的扁平器。此介面的一個實例係為可以是圓形或橢圓形的吸環扁平器，其固定在眼睛的外表面上，然後定位在雷射光學殼體上，而固定雷射、眼睛、及自然水晶體之間的距離。3維觀看及測量設備的參考標記亦可以放置在此扁平器上。此外，可以觀察到扁平器的下表面與角膜之間的介面，並且這種觀察可以作為參考。雷射患者介面的進一步實例係為具有將介面固定至眼睛的吸取能力的具有下環的裝置。該介面進一步具有平坦底部，平坦底部按壓在眼睛上，而使眼睛的形狀變得平坦。此平坦底部係由透射雷射束（並且亦較佳為（但並非必須）透射可見光譜內的眼睛的光學圖像）的材料所構成。上環具有用於與雷射光學裝置的殼體接合的結構、沿著雷射束的路徑距離雷射已知距離並且相對於雷射固定的一些結構、及這些的組合及變化。在美國專利申請公開號2011/0190739、2017/0290703、2010/0022994、2011/0022035和2015/0088175中揭示及教示的患者介面裝置、用於將PID與眼睛接合的系統、及用於將PID與雷射系統接合的系統的實例，其每一者的全部揭示內容藉由引用併入本文。 超音波/超音波晶體乳化：一般A further component of embodiments of these systems may be a laser patient interface or PID. It will be understood that all or some of the PID is typically not part of the system, but is preferably a single-use device (e.g., disposable) that is added to the system for each patient prior to or when setting up a laser procedure. In embodiments, this interface provides for the x, y, z position between the natural lens and the laser to remain fixed during a procedure that includes a measurement step that determines the xyz position and a delivery step that delivers the laser to the lens using a shot pattern. The interface device may include an optically transparent applanator. An example of such an interface is a suction ring applanator that may be circular or elliptical in shape, which is secured to the outer surface of the eye and then positioned on the laser optics housing to fix the distance between the laser, the eye, and the natural lens. Reference markers for 3D viewing and measurement equipment can also be placed on the applanator. In addition, the interface between the lower surface of the applanator and the cornea can be observed and this observation can serve as a reference. A further example of a laser patient interface is a device having a lower ring with suction capability to secure the interface to the eye. The interface further has a flat bottom that presses against the eye to flatten the shape of the eye. The flat bottom is constructed of a material that transmits the laser beam (and preferably, but not necessarily, transmits optical images of the eye in the visible spectrum). The upper ring has structure for coupling to the housing of the laser optical device, some structure that is a known distance from the laser along the path of the laser beam and is fixed relative to the laser, and combinations and variations of these. Examples of patient interface devices, systems for interfacing a PID with an eye, and systems for interfacing a PID with a laser system are disclosed and taught in U.S. Patent Application Publication Nos. 2011/0190739, 2017/0290703, 2010/0022994, 2011/0022035, and 2015/0088175, the entire disclosure of each of which is incorporated herein by reference.Ultrasonic/Ultrasonic Phacoemulsification: General
經配置以提供對於治療眼睛、其結構、及鄰近組織及其狀況有用、安全、有效的超音波能量的任何超音波產生器（例如，超音波驅動器、號角、或用於產生超音波能量的其他裝置）可以用於提供本系統的超音波能量。更特定言之，在本系統的實施例中，可以使用或重新配置以使用任何（較佳為醫療裝置規範機構所批准）超音波晶體乳化系統中的部件的一些或全部。Any ultrasonic generator (e.g., an ultrasonic driver, horn, or other device for generating ultrasonic energy) configured to provide ultrasonic energy useful, safe, and effective for treating the eye, its structures, and adjacent tissues and conditions thereof may be used to provide the ultrasonic energy of the present system. More particularly, embodiments of the present system may utilize or reconfigure to utilize some or all of the components of any (preferably medical device regulatory body approved) ultrasonic phacoemulsification system.
通常，在本整合系統的實施例以及可以執行的方法中，超音波晶體乳化包括較佳利用治療雷射束進行角膜切口、鞏膜切口（以及這些的組合及變化），以及超音波晶體乳化手持件（通常包含超音波驅動的針）的插入，以例如乳化（亦即，液化）自然晶狀水晶體，將白內障破碎成小塊，以及這些的組合及變化。較佳地，此超音波程序係在已經藉由雷射束切割、切片、軟化、及這些的組合及變化的水晶體、水晶體材料、白內障材料上進行。經乳化的塊狀物隨後可以使用相同的機頭或另一機頭來移除。然後，外科醫生可以藉由切口將植入物（例如，眼內水晶體（IOL））插入眼睛。Generally, in embodiments of the present integrated system and methods that may be performed, ultrasonic phacoemulsification includes making corneal incisions, scleral incisions (and combinations and variations thereof), preferably using a therapeutic laser beam, and inserting a ultrasonic phacoemulsification handpiece (typically comprising an ultrasound-driven needle) to, for example, emulsify (i.e., liquefy) the natural lens, break up a cataract into small pieces, and combinations and variations thereof. Preferably, the ultrasonic procedure is performed on the lens, lens material, or cataract material that has been cut, sliced, softened, or combinations and variations thereof by the laser beam. The emulsified pieces can then be removed using the same handpiece or another handpiece. The surgeon can then insert an implant (e.g., an intraocular lens (IOL)) into the eye through the incisions.
在實施例中，超音波乳化針的尖端的振動的超音波乳化頻率可以大於約20kHz、大於30kHz、大於40kHz、約30kHz至約50kHz、約30kHz至約45kHz、少於約50kHz、約35kHz至約45kHz、約35kHz、約40kHz、約45kHz、35kHz、40kHz、45kHz、及這些與更高及更低的頻率的組合及變化。In an embodiment, the ultrasonic emulsification frequency of the vibration of the tip of the ultrasonic emulsification needle can be greater than about 20 kHz, greater than 30 kHz, greater than 40 kHz, about 30 kHz to about 50 kHz, about 30 kHz to about 45 kHz, less than about 50 kHz, about 35 kHz to about 45 kHz, about 35 kHz, about 40 kHz, about 45 kHz, 35 kHz, 40 kHz, 45 kHz, and combinations and variations of these and higher and lower frequencies.
在實施例中，超音波乳化針的行程（縱向移動）的長度可以是約28.1μm至約95.25μm、約25µm至約160μm、約50μm至約90μm、約50μm至約150μm、約25μm至約110μm、約35μm至約100μm、約20μm至約60μm、約80μm至約150μm、以及這些與更大及更小的距離的組合及變化。In embodiments, the length of the stroke (longitudinal movement) of the sonic emulsification needle can be about 28.1 μm to about 95.25 μm, about 25 μm to about 160 μm, about 50 μm to about 90 μm, about 50 μm to about 150 μm, about 25 μm to about 110 μm, about 35 μm to about 100 μm, about 20 μm to about 60 μm, about 80 μm to about 150 μm, and combinations and variations thereof of larger and smaller distances.
通常，超音波乳化系統的脈衝速率可以是每秒約20個脈衝至每秒約150個脈衝，以及這些與更高及更低的值的組合及變化。並且，這些系統的短脈衝寬度可以是約30毫秒至約4毫秒，以及這些與更高及更低的值的組合及變化。Typically, the pulse rate of a phacoemulsification system can be from about 20 pulses per second to about 150 pulses per second, and combinations and variations thereof with higher and lower values. Also, the pulse width of such systems can be from about 30 milliseconds to about 4 milliseconds, and combinations and variations thereof with higher and lower values.
在本系統的實施例中，超音波晶體乳化手持件通常耦接至沖洗源及抽吸泵。抽吸泵係位於系統中的殼體。手持件包括用於插入患者眼睛的前房內的遠側尖端，遠側尖端發射超音波能量或利用超音波頻率進行振動，以針對晶狀或自然水晶體進行切割、乳化、及這些的組合及變化。手持件進一步包括：接近遠側尖端的沖洗埠，經由沖洗管線耦接至沖洗源；以及在遠側尖端處的抽吸埠，經由抽吸管線耦接至抽吸泵。來自沖洗源的流體（通常是一瓶鹽溶液）係經由沖洗管線及沖洗埠而沖洗進入眼睛，並經由抽吸埠及抽吸管線藉由抽吸泵從眼睛抽吸沖洗流體及經乳化的水晶體材料。In an embodiment of the present system, an ultrasonic phacoemulsification handpiece is typically coupled to an irrigation source and an aspiration pump. The aspiration pump is housed in a housing within the system. The handpiece includes a distal tip for insertion into the anterior chamber of a patient's eye, the distal tip emitting ultrasonic energy or vibrating at ultrasonic frequencies to target, emulsify, or combinations and variations of the crystalline lens or natural lens. The handpiece further includes an irrigation port proximal to the distal tip coupled to the irrigation source via an irrigation line, and an aspiration port at the distal tip coupled to the aspiration pump via an aspiration line. Fluid from an irrigation source (usually a bottle of saline solution) is flushed into the eye through the irrigation line and irrigation port, and the irrigation fluid and emulsified lens material are withdrawn from the eye through the suction port and suction line by a suction pump.
超音波系統可以經配置以執行的用於眼睛的其他醫學技術通常亦包括乳化、沖洗眼睛、及抽吸。這樣的程序可以包括或可以不包括使用乳化、沖洗、及抽吸來破壞、改變、或移除自然眼睛的特徵。因此，藉由系統、藉由外科醫生、及藉由這些的組合及變化來選擇及控制由外科手術控制台遞送的超音波功率、藉由沖洗或抽吸控制台流向患者及從患者流出的流體的流動、及控制超音波晶體乳化手持件來遞送前者的後續需要。Other medical techniques for the eye that the ultrasound system can be configured to perform also typically include emulsification, eye irrigation, and aspiration. Such procedures may or may not include the use of emulsification, irrigation, and aspiration to damage, alter, or remove features of the natural eye. Thus, the ultrasound power delivered by the surgical console, the flow of fluid to and from the patient via the irrigation or aspiration console, and control of the ultrasonic phacoemulsification handpiece are selected and controlled by the system, by the surgeon, and by combinations and variations of these.
本系統的實施例的超音波晶體乳化部件（例如，子組件）通常包括控制系統（例如，可程式化微處理器），以及用於控制例如抽吸速率、真空、及超音波功率等級的具有操作者選擇的預設的控制台（在實施例中，控制台係為系統監控器）。超音波晶體乳化手持件可以藉由電纜與系統互連，電纜用於針對提供乳化作用的壓電轉換器進行供電及控制。在控制台的控制下，管狀物透過手持件向眼睛提供沖洗流體，並使抽吸流體能夠從眼睛排出。The ultrasonic phacoemulsification components (e.g., subassemblies) of embodiments of the present system generally include a control system (e.g., a programmable microprocessor) and a console (in embodiments, the console is a system monitor) with operator-selectable presets for controlling, for example, aspiration rate, vacuum, and ultrasound power level. The ultrasonic phacoemulsification handpiece can be interconnected with the system via a cable that provides power and control to the piezoelectric transducer that provides emulsification. Under control of the console, a tube provides irrigation fluid to the eye through the handpiece and enables aspirated fluid to be drained from the eye.
在實施例中，在手持件的操作期間始終決定及測量與手持件操作相關聯的相位角度及其他態樣（例如，以調整驅動電路，實現最佳相位角度，以及影響從超音波晶體乳化手持件進入組織的能量轉移）。可以藉由監視手持件電訊號並調整頻率及其他態樣以維持與所選擇參數的一致性來提供手持件的自動調諧。In embodiments, phase angles and other characteristics associated with handpiece operation are determined and measured continuously during handpiece operation (e.g., to adjust driver circuitry to achieve an optimal phase angle and affect energy transfer from the ultrasonic phacoemulsification handpiece into tissue). Automatic tuning of the handpiece can be provided by monitoring handpiece electrical signals and adjusting frequency and other characteristics to maintain consistency with selected parameters.
在實施例中，控制系統依據施加至手持件壓電轉換器的電壓與壓電轉換器所汲取的電流之間的相位角度、提供至手持件的功率脈衝的幅度、及這兩者，來解決超音波晶體乳化手持件的功率控制的要求。可以針對特定的手持件來調諧典型的佈置，並且例如可以在外科醫師的控制下以連續方式或以一系列實心短脈衝的形式施加功率。舉例而言，系統可以施加功率150毫秒，然後停止功率350毫秒，並且可以在功率施加的必要持續時間內重複此開/關序列。在前述的150ms週期期間的功率的施加可以定義為25kHz至50kHz的正弦波的恆定施加。在某些情況下，外科醫生或操作者可以在一段持續時間內施加功率短脈衝，然後停止功率的施加，然後以初始或其他功率設定來重新施加。短脈衝的頻率與持續時間通常是可控制的，施加到受影響區域的短脈衝流的長度也是可控制的。不施加功率的時間週期可以啟用可以使用抽吸（例如，可以藉由手持件或輔助抽吸設備所提供）來移除破碎區段的週期。In one embodiment, a control system addresses the power control requirements of an ultrasonic phacoemulsification handpiece based on the phase angle between the voltage applied to the handpiece's piezoelectric converter and the current drawn by the piezoelectric converter, the amplitude of the power pulses provided to the handpiece, and both. Typical configurations can be tuned for specific handpieces, and power can be applied continuously or in a series of short, solid pulses, for example, under the surgeon's control. For example, the system can apply power for 150 milliseconds, then stop for 350 milliseconds, and repeat this on/off sequence for the necessary duration of power application. The power application during the aforementioned 150-ms period can be defined as a constant application of a 25-kHz to 50-kHz sine wave. In some cases, the surgeon or operator can apply a short pulse of power for a sustained period of time, then discontinue the application of power and then reapply it at the initial or another power setting. The frequency and duration of the short pulses are typically controllable, as is the length of the short pulses applied to the affected area. Periods of time without power can enable periods in which suction (e.g., as provided by a handpiece or an auxiliary suction device) can be used to remove the fragmented segment.
在本系統的實施例中，用於超音波功率遞送的控制方法通常可以處於幾種模式（例如，可變、預先決定可變、面板、及線性）。可變模式針對外科醫生或操作者提供選擇超音波治療的最大靈活性，而可以視為手動。預先決定可變模式係為模式，其中控制系統依據所提供的雷射治療、白內障的等級、及在雷射治療程序之前、期間、及之後系統所取得的其他資訊來決定超音波治療的最佳範圍。因此，在此模式下，與雷射控制器系統及超音波晶體乳化控制系統協同工作的系統可以預先決定並可取得用於超音波晶體乳化程序的推薦且較佳的最佳化範圍及設定。通常，面板模式通常在使用者選擇時提供嚴格的固定值。通常，線性模式僅允許0％至100％的最簡單形式的線性調整。在實施例中，中間調整或超出系統推薦的用於超音波治療的遞送選項或範圍的調整並非可以自由取得（例如，受到限制，部分是為了使手動調整的需要及固有風險最小化）。In embodiments of the present system, the control method for ultrasound power delivery can generally be in several modes (e.g., variable, pre-determined variable, panel, and linear). The variable mode provides the surgeon or operator with the greatest flexibility in selecting ultrasound treatments and can be considered manual. The pre-determined variable mode is a mode in which the control system determines the optimal range for the ultrasound treatment based on the laser treatment being provided, the grade of the cataract, and other information obtained by the system before, during, and after the laser treatment procedure. Therefore, in this mode, the system working in conjunction with the laser controller system and the ultrasonic phacoemulsification control system can pre-determine and obtain recommended and preferred optimization ranges and settings for the ultrasonic phacoemulsification procedure. Generally, the panel mode generally provides strict fixed values when selected by the user. Typically, the linear mode allows only the simplest form of linear adjustment from 0% to 100%. In embodiments, intermediate adjustments or adjustments outside the system's recommended delivery options or ranges for ultrasound therapy are not freely accessible (e.g., they are restricted, in part, to minimize the need for manual adjustments and their inherent risks).
超音波晶體乳化超音波探針將能量遞送進入眼睛，以用於在雷射碎裂或切割之後破碎剩餘的白內障水晶體材料，以促進剩餘物的乳化及抽吸。超音波晶體乳化超音波探針將能量遞送進入眼睛，以用於破碎白內障，其中並未執行白內障的雷射碎裂（例如，在外科醫生選擇進行雷射囊切開術及雷射切口，以插入超音波晶體乳化探針，但不使用雷射碎裂水晶體或白內障）。超音波晶體乳化超音波探針將能量遞送進入眼睛，以用於破碎白內障，藉由將控制開關（例如，腳踏板）踩到預先決定的位置時利用固定頻率振動來實現此舉，相同控制開關可以控制治療雷射束及圖案的擊發或遞送，亦可以使用其他類型的控制開關、按鈕、觸發器、聲音等。在實施例中，為了增加超音波功率的量，機器增加探針的行程長度。Phacoemulsification uses an ultrasound probe to deliver energy into the eye to fragment the remaining cataractous lens material after laser fragmentation or ablation to promote emulsification and aspiration of the remaining material. Phacoemulsification uses an ultrasound probe to deliver energy into the eye to fragment the cataract without laser fragmentation of the cataract (e.g., when the surgeon chooses to perform a laser capsulotomy and laser incision to insert the phacoemulsification probe, but does not use the laser to fragment the lens or cataract). The ultrasonic phacoemulsification ultrasound probe delivers energy into the eye to fragment cataracts. This is achieved by utilizing fixed-frequency vibrations when a control switch (e.g., a foot pedal) is depressed to a predetermined position. The same control switch can control the firing or delivery of the therapeutic laser beam and pattern. Other types of control switches, buttons, triggers, sounds, etc. may also be used. In one embodiment, to increase the amount of ultrasonic power, the machine increases the probe's stroke length.
通常，探針可以利用縱向方式、橫向方式、及這些的組合及變化來遞送功率。超音波乳化針係以縱向方式前後移動。利用後一種方式，超音波功率亦透過探針的橫向運動進行遞送，並且可以例如藉由減少水晶體材料的排斥而提高切割效率。Typically, a probe can deliver power using a longitudinal approach, a transverse approach, or a combination or variation of these approaches. The sonic emulsification needle moves back and forth in a longitudinal approach. With the latter approach, ultrasonic power is also delivered through the probe's transverse motion, which can improve ablation efficiency, for example, by reducing rejection of crystalline material.
通常，在超音波晶體乳化中存在兩種類型的橫向運動。在扭轉橫向運動中，超音波乳化尖端沿其主軸線以旋轉方式進行振動。在橫跨橫向運動中，超音波乳化尖端沿著橢圓形路徑進行移動。通常，依據其運動類型，扭轉通常對於具有角度的超音波乳化針更好，而橫跨通常對於筆直或成角度的針同樣好。由於白內障材料在一個以上的方向上被乳化，因此將橫向運動超音波乳化與傳統縱向超音波晶體乳化組合可以有助於切割效率。Generally, there are two types of lateral motion in phacoemulsification. In torsional lateral motion, the phacoemulsification tip is oscillated rotationally along its main axis. In transverse lateral motion, the phacoemulsification tip moves along an elliptical path. Generally, depending on the type of motion, torsional motion is generally better for angled phacoemulsification needles, while transverse motion is generally equally effective for straight or angled needles. Because cataract material is emulsified in more than one direction, combining lateral motion phacoemulsification with traditional longitudinal phacoemulsification can help improve ablation efficiency.
儘管該領域將超音波晶體乳化描述為遞送超音波能量，但應理解，當金屬超音波乳化針擊中目標材料（例如，雷射所影響的白內障材料）時，超音波乳化針的行程會產生機械衝擊。通常，由於在超音波乳化針的正前方會形成微孔，所以針亦會產生氣穴及內爆。流體及顆粒波傳播進入白內障材料，最後產生熱來作為副產物。重要的是要避免選擇造成過多熱積聚的超音波乳化功率設定，因為此舉會灼傷角膜並損傷脆弱的眼部結構。藉由周圍沖洗套管的無限制流動也非常重要，因為平衡的鹽溶液圍繞超音波乳化探針移動所產生的恆定冷卻效果有助於防止熱積聚。Although the field describes phacoemulsification as delivering ultrasonic energy, it should be understood that the travel of the metal phacoemulsification needle produces mechanical shock as it strikes the target material (e.g., cataract material affected by the laser). Often, the needle also cavitates and implodes due to the formation of micropores directly in front of the phacoemulsification needle. Fluid and particle waves propagate into the cataract material, ultimately generating heat as a byproduct. It is important to avoid selecting a phacoemulsification power setting that causes excessive heat buildup, as this can burn the cornea and damage delicate ocular structures. Unrestricted flow through the peripheral flushing cannula is also important because the constant cooling effect created by the balanced saline solution moving around the Emulsification probe helps prevent heat buildup.
在本系統的實施例中，在外科手術期間，系統控制器、超音波乳化控制器、及這些的組合及變化可以監視、記錄、及分析以最大百分比給定的平均超音波乳化功率、遞送超音波乳化超音波功率期間的總時間、及其他條件及因素。在實施例中，共同監視器可以將這些值顯示為「U/S AVE」（代表「超音波平均」）、「EPT」（「經過的超音波乳化時間」）、及其他參數及特徵。遞送進入眼睛的總能量係為超音波乳化功率乘以功率開啟時間的乘積（亦即，絕對超音波乳化時間（APT））。藉由將「U/S AVE」乘以「EPT」，系統控制器、超音波乳化控制器、及這些的組合及變化可以自動計算APT，而使得外科醫生可以比較不同情況下遞送的總超音波能量。In embodiments of the present system, during surgery, the system controller, the phacoemulsification controller, and combinations and variations of these can monitor, record, and analyze the average phacoemulsification power given as a percentage of maximum, the total time during which phacoemulsification ultrasound power was delivered, and other conditions and factors. In embodiments, the common monitor can display these values as "U/S AVE" (for "ultrasound average"), "EPT" (for "elapsed phacoemulsification time"), and other parameters and characteristics. The total energy delivered to the eye is the product of the phacoemulsification power multiplied by the time the power was on (i.e., the absolute phacoemulsification time (APT)). System controllers, phacoemulsification controllers, and combinations and variations of these can automatically calculate APT by multiplying "U/S AVE" by "EPT," allowing the surgeon to compare the total ultrasound energy delivered under different circumstances.
在實施例中，為了最大程度降低APT，外科醫生需要降低超音波乳化時間、平均超音波乳化功率、及這些的組合及變化。可以藉由在監視器上選擇參數、透過限制控制開關的位置、或者藉由降低機器上的最大超音波乳化功率等級，來降低平均超音波乳化功率。可以僅當白內障物質位於超音波乳化尖端且僅憑真空不足以抽吸物質時才藉由施加超音波功率，來降低超音波晶體乳化時間。此外，可以藉由遞送更短的脈衝或超音波乳化功率的短脈衝來代替連續的超音波功率，或者藉由降低工作循環（開/關脈衝的比率）來減少超音波乳化時間。將超音波功率分解成較小的脈衝及短脈衝包的此方法係稱為超音波乳化功率調變。In embodiments, to minimize APT, the surgeon needs to reduce the phacoemulsification time, average phacoemulsification power, or combinations and variations of these. Average phacoemulsification power can be reduced by selecting a parameter on a monitor, by limiting the position of a control switch, or by lowering the maximum phacoemulsification power level on the machine. Phaeemulsification time can be reduced by applying ultrasound power only when cataract material is at the phacoemulsification tip and vacuum alone is insufficient to aspirate the material. Furthermore, phacoemulsification time can be reduced by delivering shorter pulses or short bursts of phacoemulsification power instead of continuous ultrasound power, or by reducing the duty cycle (the ratio of on/off pulses). This method of breaking up ultrasonic power into smaller pulses and short pulse packets is called transemulsification power modulation.
在實施例中，基本功率設定可以是連續的、脈衝的、及短脈衝的。在連續的功率設定中，能量遞送是連續的，其中功率的變化係藉由控制開關位置（例如，腳踏板的下踩量）所控制。In an embodiment, the base power setting can be continuous, pulsed, or short pulse. In a continuous power setting, energy delivery is continuous, wherein the power variation is controlled by the position of a control switch (e.g., the amount of pedal depression).
在實施例中，因為藉由控制系統與超音波乳化控制系統的結合使用可以利用預先決定的方式更精確地決定及提供功率的變化（以及在某些情況下亦需要由外科醫生輸入），系統可以提供這些的組合及變化以及提供用於提供這些功率模式的混合或混用等級的功率設定。In embodiments, because power variations can be more accurately determined and provided in a predetermined manner by the control system used in conjunction with the phacoemulsification control system (and in some cases also requiring input from the surgeon), the system can provide these combinations and variations as well as power settings for providing mixed or hybrid levels of these power modes.
在實施例中，在脈衝模式下，脈衝功率藉由控制開關的位置（例如，踩下腳踏板多遠）線性增加。定位（例如，壓低）得越遠，則每一連續的能量脈衝的功率越大。脈衝模式操作的實施例的特徵在於，在每一能量脈衝被遞送之後，存在一段在能量脈衝的增加之間沒有能量被遞送的時間週期（亦即，「關閉」週期）。在相等的「開啟」及「關閉」脈衝時間之間進行交替可以減少熱，並將一半的能量遞送進入眼睛。In an embodiment, in pulse mode, the pulse power increases linearly by controlling the position of the control switch (e.g., how far the foot pedal is depressed). The farther it is positioned (e.g., depressed), the greater the power of each successive energy pulse. A characteristic feature of embodiments operating in pulse mode is that after each energy pulse is delivered, there is a period of time (i.e., an "off" period) during which no energy is delivered between increases in energy pulses. Alternating between equal "on" and "off" pulse times reduces heating and delivers half the energy to the eye.
在實施例中，在短脈衝模式中，每一短脈衝具有相同的功率，但是每一短脈衝之間的間隔隨著控制開關的前進（例如，腳踏板被踩下）而降低。在實施例中，控制開關被推進得越遠（例如，腳踏板被踩下），則每一短脈衝之間的「關閉」週期越短。因此，在實施例中，在最大控制開關位置處（例如，在最大腳踏板下壓處），能量的短脈衝變成能量的連續遞送。In an embodiment, in burst mode, each burst has the same power, but the interval between each burst decreases as the control switch is advanced (e.g., as the pedal is depressed). In an embodiment, the further the control switch is advanced (e.g., as the pedal is depressed), the shorter the "off" period between each burst. Thus, in an embodiment, at the maximum control switch position (e.g., at maximum pedal depression), a short burst of energy becomes a continuous delivery of energy.
在實施例中，短脈衝模式可以提供水晶體的水晶體核的超音波乳化輔助抽吸。外科醫生使用超音波乳化機的真空及流體來抽吸白內障，然後僅在必要時才提供超音波乳化功率的較小短脈衝。因為一個（較佳為）控制系統可以針對這些超音波乳化功率的短脈衝進行程式化或推薦成非常短（短至幾毫秒），所以可以有效地遞送數百個小短脈衝，並且仍然少於例如1秒的總超音波乳化時間。In one embodiment, a burst mode can provide phacoemulsification-assisted aspiration of the lens nucleus. The surgeon uses the vacuum and fluid of the phacoemulsification machine to aspirate the cataract, then delivers small bursts of phacoemulsification power only when necessary. Because a (preferably) control system can program or recommend very short bursts of phacoemulsification power (as short as a few milliseconds), hundreds of these small bursts can be effectively delivered and still achieve a total phacoemulsification time of less than, for example, one second.
本系統提供脈衝及短脈衝超音波晶體乳化設定以及其他設定的可程式範圍具有與現有系統相同的特徵的實施例，並且在實施例中，大幅擴展現有系統。與任何現有系統不同，本系統的實施例提供具有依據遞送雷射圖案或治療的雷射系統來預先決定及推薦超音波乳化設定的能力，並且可以立即提供那些設定，而不需要外科醫師或患者進行移動。The present system provides embodiments having the same features as existing systems with a programmable range of pulsed and short-pulse phacoemulsification settings and other settings, and in embodiments significantly extends existing systems. Unlike any existing system, embodiments of the present system provide the ability to predetermine and recommend phacoemulsification settings based on the laser system delivering the laser pattern or treatment, and can provide those settings immediately without requiring the surgeon or patient to move.
在實施例中，單獨的超音波乳化控制系統或與系統控制系統組合的超音波乳化控制系統可以執行各種主動的監視及控制功能，例如： 監視眼內壓力（IOP）並且可以調整系統的功能，以將IOP維持在所期望的壓力處；監測及控制真空等級；最佳化功率設定；以及預測壓力改變並主動回應閉塞中斷。用於提供針對超音波乳化系統操作參數的監視及自主控制的此資訊及資料的感測器可以位於系統中、位於各種泵及裝置上、基於電流或其他電負載、或者位於手持件中或手持件上。In embodiments, the phacoemulsification control system, alone or in combination with the system control system, can perform various active monitoring and control functions, such as: monitoring intraocular pressure (IOP) and adjusting system functions to maintain the IOP at a desired pressure; monitoring and controlling vacuum levels; optimizing power settings; and anticipating pressure changes and proactively responding to closure interruptions. Sensors used to provide this information and data for monitoring and autonomous control of phacoemulsification system operating parameters can be located in the system, on various pumps and devices, based on electrical current or other electrical loads, or in or on the handpiece.
在本超音波乳化雷射系統中可以使用的效能特徵及部件的實例係為Alcon CENTURION®視覺系統、Alco ACTIVE SENTRY®手持件、及INTREPID®混合尖端。在實施例中，超音波乳化手持件可以具有內建的流體壓力感測器，用於即時偵測壓力並與系統控制系統、光系統控制系統、或兩者進行通訊。在本超音波乳化雷射系統中可以使用的各種特徵及部件的實例係為AMO WHITESTAR SIGNATURE®PRO超音波晶體乳化系統。Examples of performance features and components that can be used in this phacoemulsification laser system are the AlconCENTURION® vision system, the Alco ACTIVESENTRY® handpiece, and theINTREPID® hybrid tip. In one embodiment, the phacoemulsification handpiece can have a built-in fluid pressure sensor for real-time pressure detection and communication with the system control system, the optical system control system, or both. An example of various features and components that can be used in this phacoemulsification laser system is the AMO WHITESTARSIGNATURE® PRO phacoemulsification system.
在美國專利號8,020,565、9,549,850、9,549,851、9,849,030、9,877,865、9,931,447、9,937,077、10,258,505、10,314,953、10,111,990以及美國專利公開號2019/0133824、2019/0021906、2019/0099526、2017/0266046、及2017/0112668中揭示並教示超音波乳化系統及子系統的特徵、使用方法、及部件，其每一者的全部揭示內容藉由引用併入本文。Features, methods of use, and components of ultrasonic emulsification systems and subsystems are disclosed and taught in U.S. Patent Nos. 8,020,565, 9,549,850, 9,549,851, 9,849,030, 9,877,865, 9,931,447, 9,937,077, 10,258,505, 10,314,953, 10,111,990 and U.S. Patent Publication Nos. 2019/0133824, 2019/0021906, 2019/0099526, 2017/0266046, and 2017/0112668, the entire disclosure of each of which is incorporated herein by reference.
超音波雷射組合：一般Ultrasonic laser combination: General
這些實施例包括任何組合的雷射超音波系統，並且更特定為包括組合的超音波晶體乳化雷射系統，以及組合的超音波晶體乳化飛秒雷射系統（「毫微微超音波乳化」或「超音波乳化毫微微」，除非另有特別說明，否則可以互換使用）。這些實施例可以具有或利用本說明書所揭示的治療雷射及系統、雷射束遞送、雷射控制系統、位置及形狀決定、患者介面、及超音波/超音波晶體乳化的一般教示的實施例、特徵、功能、參數、部件、或系統中之一或更多者以及實例中的系統的特徵中之一或更多者。These embodiments include any combination of laser ultrasound systems, and more particularly, include a combination of ultrasound phacoemulsification laser systems, and a combination of ultrasound phacoemulsification femtosecond laser systems ("femtophacoemulsification" or "phacoemulsification femto," used interchangeably unless otherwise specifically stated). These embodiments may have or utilize one or more of the embodiments, features, functions, parameters, components, or systems of the general teachings of therapeutic lasers and systems, laser beam delivery, laser control systems, position and shape determination, patient interface, and ultrasound/phacoemulsification disclosed herein, as well as one or more of the features of the systems in the embodiments.
在雷射超音波系統的較佳實施例（特定為雷射超音波乳化系統，並且更特定為毫微微超音波乳化系統）中，該系統具有可以藉由相同或不同的雷射源提供的兩個治療雷射束，一者是短脈衝持續時間雷射束，另一者是長脈衝持續時間雷射束。In a preferred embodiment of a laser ultrasound system (particularly a laser ultrasound emulsification system, and more particularly a femto ultrasound emulsification system), the system has two therapeutic laser beams, one with a short pulse duration and the other with a long pulse duration, which can be provided by the same or different laser sources.
通常，短脈衝持續時間雷射係用於執行針對角膜的程序（例如，切割角膜、角膜緣鬆弛切口等）。通常，長脈衝持續時間雷射束係用於執行針對水晶體的程序（例如，囊切開、水晶體碎裂、白內障碎裂等）。Typically, short pulse duration lasers are used to perform procedures on the cornea (e.g., corneal ablation, limbal relaxation incisions, etc.). Typically, long pulse duration laser beams are used to perform procedures on the lens (e.g., capsulotomy, lens fragmentation, cataract fragmentation, etc.).
具有多種類型的不同治療雷射束（例如，短脈衝持續時間與長脈衝持續時間）的這些實施例可以具有或利用本說明書所揭示的治療雷射及系統、雷射束遞送、雷射控制系統、位置及形狀決定、患者介面、及超音波/超音波晶體乳化的一般教示的實施例、特徵、功能、參數、部件、或系統中之一或更多者以及實例中的系統的特徵中之一或更多者。These embodiments having various types of different therapeutic laser beams (e.g., short pulse duration versus long pulse duration) may have or utilize one or more of the embodiments, features, functions, parameters, components, or systems of the general teachings of therapeutic lasers and systems, laser beam delivery, laser control systems, position and shape determination, patient interface, and ultrasound/ultrasonic phacoemulsification disclosed herein, as well as one or more of the features of the systems in the embodiments.
系統（例如，毫微微超音波乳化系統）可以具有多個治療雷射束（例如，具有不同性質的1、2、3、4、或更多個光束）。這些雷射束可以遵循相同的雷射束路徑，而因此行進通過相同的光學部件並與其互動，或者可以行進通過不同的雷射束路徑，而因此行進通過不同的光學部件並與其交互，以及這些的組合及變化。舉例而言，該系統可以包含具有第一脈衝持續時間及第一功率或能量的第一束、具有第二脈衝持續時間及第二功率或能量的第二束、及具有第三脈衝持續時間及第三功率或能量的第三束。第一、第二、及第三脈衝持續時間、第一、第二、及第三功率、及第一、第二、及第三能量可以相同、不同、及這些的組合及變化。A system (e.g., a femto-phacoemulsification system) can have multiple therapeutic laser beams (e.g., 1, 2, 3, 4, or more beams with different properties). These laser beams can follow the same laser beam path, and thus travel through and interact with the same optical components, or they can travel through different laser beam paths, and thus travel through and interact with different optical components, as well as combinations and variations of these. For example, the system can include a first beam having a first pulse duration and a first power or energy, a second beam having a second pulse duration and a second power or energy, and a third beam having a third pulse duration and a third power or energy. The first, second, and third pulse durations, the first, second, and third powers, and the first, second, and third energies may be the same, different, or combinations and variations thereof.
在實施例中，多治療雷射束雷射系統係與另一治療裝置（例如，超音波裝置、診斷裝置、及這些的組合及變化）相關聯（整合或模組化）。In an embodiment, the multi-therapy laser system is associated with (integrated or modularized with) another treatment device (e.g., an ultrasound device, a diagnostic device, and combinations and variations of these).
在藉由相同的治療雷射源提供長脈衝持續時間及短脈衝持續時間的雷射束的實施例中，在脈衝長度之間切換的時間係少於約3秒（sec）、少於約2sec、少於約1.5sec、約3sec至1sec、約2sec、約3sec，以及這些與較長及較短時間的組合及變化。In embodiments where the laser beams are provided with long pulse durations and short pulse durations by the same therapeutic laser source, the time for switching between pulse lengths is less than about 3 seconds (sec), less than about 2 sec, less than about 1.5 sec, about 3 sec to 1 sec, about 2 sec, about 3 sec, and combinations and variations of these and longer and shorter times.
儘管本發明的較佳實施例係針對雷射超音波（更特定為毫微微超音波乳化系統），但應理解，針對雷射系統的本改善及實施例具有價值，並且可以單獨使用，而不是作為雷射超音波系統的一部分。Although the preferred embodiments of the present invention are directed to laser ultrasound (more specifically, femto-hypodermic emulsification systems), it should be understood that the present improvements and embodiments directed to laser systems have value and can be used alone, rather than as part of a laser ultrasound system.
這些本系統的實施例提供優於先前技術的重要優點。因為本系統可以提供最佳化的雷射能量圖案，所以可以在遞送之後針對眼睛進行評估，然後不需要移動患者，然後以最小的時間延遲（少於1分鐘、少於30sec、少於15sec）執行超音波乳化程序，而可以實現在白內障手術期間使用儘可能少的超音波乳化能量的重要目標，並且對於所有患者而言，較佳為利用預先決定的方式完成。 實例These embodiments of the present system offer significant advantages over prior art. Because the present system provides an optimized laser energy pattern, the eye can be evaluated after delivery, and the phacoemulsification procedure can be performed with minimal delay (less than 1 minute, less than 30 seconds, less than 15 seconds) without moving the patient. This achieves the important goal of using the least amount of phacoemulsification energy possible during cataract surgery, preferably in a predetermined manner for all patients.Example
提供下列實施例以說明本發明的系統、系統的部件、處理、組成物、應用、及材料的各種實施例。這些實例僅用於說明目的，可以是預言性，而不應視為限制性，並未以其他方式限制本發明的範圍。The following examples are provided to illustrate various embodiments of the systems, system components, processes, compositions, applications, and materials of the present invention. These examples are for illustrative purposes only and may be prophetic but should not be considered restrictive, and do not otherwise limit the scope of the present invention.
這些實例1至36的實施例可以具有或利用本說明書所揭示的治療雷射及系統、雷射束遞送、雷射控制系統、位置及形狀決定、患者介面、超音波/超音波乳化、及超音波乳化毫微微組合一般教示的實施例、處理、方法、特徵、功能、參數、部件、或系統中之一或更多者，以及這些中之每一者的組合及變化；以及本說明書所提供的其他實例與其他實施例中之一或更多者所提供的實施例、處理、方法、特徵、功能、參數、部件、或系統中之一或更多者。These embodiments of Examples 1 to 36 may have or utilize one or more of the embodiments, processes, methods, features, functions, parameters, components, or systems of the general teachings of therapeutic lasers and systems, laser beam delivery, laser control systems, position and shape determination, patient interface, ultrasound/phacoemulsification, and phacoemulsification femto combinations disclosed in this specification, as well as combinations and variations of each of these; and one or more of the embodiments, processes, methods, features, functions, parameters, components, or systems provided in one or more of the other examples and embodiments provided in this specification.
實例1Example 1
轉至第2圖，圖示毫微微超音波乳化雷射系統200的實施例的局部切除透視圖。系統200具有容納在共同殼體206內的雷射子系統204與超音波晶體乳化子系統205。雷射子系統204包括治療雷射束源，並且在實施例中包括慢脈衝持續時間與長脈衝持續時間的治療雷射束源。雷射子系統204包括用於定義治療雷射束所沿著行進的治療雷射束路徑的雷射以及沿著雷射束路徑定位或放置的光學部件。這些部件包括z方向聚焦光學裝置以及xy掃描器。Turning to FIG. 2 , a partially cutaway perspective view of an embodiment of a femto-phacoemulsification laser system 200 is shown. System 200 includes a laser subsystem 204 and a phacoemulsification subsystem 205 housed within a common housing 206. Laser subsystem 204 includes a therapeutic laser beam source, and in one embodiment, includes a therapeutic laser beam source with slow pulse duration and a therapeutic laser beam source with long pulse duration. Laser subsystem 204 includes a laser for defining a therapeutic laser beam path along which the therapeutic laser beam travels, as well as optical components positioned or disposed along the laser beam path. These components include z-direction focusing optics and an xy scanner.
系統200具有容納治療雷射束路徑以及其他光學路徑的臂201。在實施例中，臂201亦容納或承載用於成像及定位設備203的控制及功率電纜以及對接組件（在此圖式中未圖示）。臂201在其近端處具有治療雷射束遞送頭202。雷射遞送頭202具有位置及形狀決定設備，其可以是OCT系統或本實例的沙姆系統，以及這些與其他形狀及位置決定設備的組合及變化。雷射遞送頭具有用於與PID組合而對接至患者的眼睛的對接及定位系統。System 200 has an arm 201 that houses the therapeutic laser beam path and other optical paths. In one embodiment, arm 201 also houses or carries control and power cables and docking components for an imaging and positioning device 203 (not shown in this figure). Arm 201 has a therapeutic laser beam delivery head 202 at its proximal end. Laser delivery head 202 has a position and shape determining device, which can be an OCT system or, in this example, a Sham system, as well as combinations and variations of these and other shape and position determining devices. The laser delivery head has a docking and positioning system for docking to the patient's eye in combination with a PID.
系統200具有用於雷射子系統204及超音波乳化子系統205的共同功率供應器207。共同功率供應器207針對整個系統提供所有功率，而消除對於輔助功率供應器或多個功率源的需求。此舉允許系統插入手術室中的單一功率供應器。System 200 has a common power supply 207 for the laser subsystem 204 and the phacoemulsification subsystem 205. The common power supply 207 provides all power to the entire system, eliminating the need for auxiliary power supplies or multiple power sources. This allows the system to be plugged into a single power supply in the operating room.
系統200具有共同控制系統208。共同控制系統208具有控制器操作控制軟體或操作指令。在較佳實施例中，共同控制系統208係與下列一或更多者（較佳為全部）進行控制通訊：雷射子系統中的控制系統及控制器212；超音波乳化子系統中的控制系統及控制器211；與操作者介面209進行控制通訊；與緊急停止裝置210進行控制通訊；以及與例如患者醫療紀錄系統、會計系統、及這些配置的組合及變化的網路進行通訊。System 200 includes a common control system 208. Common control system 208 includes controller operating software or operating instructions. In a preferred embodiment, common control system 208 communicates with one or more (preferably all) of the following: a control system and controller 212 in the laser subsystem; a control system and controller 211 in the phacoemulsification subsystem; an operator interface 209; an emergency stop device 210; and a network, such as a patient medical record system, an accounting system, and combinations and variations of these.
通常，對接系統以及成像及位置決定設備係藉由雷射子系統控制系統進行控制。在實施例中，可以全部或部分地藉由共同控制系統208直接控制。Typically, the docking system and imaging and position determination equipment are controlled by the laser subsystem control system. In an embodiment, all or part of them can be directly controlled by the common control system 208.
在實施例中，雷射控制系統及超音波控制系統係為部分的，並且可以完全整合進入單一共同控制系統。因此，在實施例中，在毫微微超音波乳化系統中僅存在一個控制系統或單一控制系統。In embodiments, the laser control system and the ultrasonic control system are partial and can be fully integrated into a single common control system. Thus, in embodiments, there is only one control system or a single control system in the femto-phacoemulsification system.
實例2Example 2
轉至第3圖，沿著實例1的線段圖示毫微微超音波乳化系統的實施例，相同數字表示相同部件。在第3圖的實施例中，xy掃描器301係位於雷射遞送頭202中。Turning to FIG3 , an embodiment of a femto-phacoemulsification system is shown along the lines of Example 1 , with like numerals representing like components. In the embodiment of FIG3 , an xy scanner 301 is located in the laser delivery head 202 .
實例3Example 3
轉至第4圖以及第4A圖至第4D圖，圖示用於本雷射系統、雷射超音波系統、及更特定為毫微微超音波乳化系統的實施例的光學路徑及光學配置的示意圖。Turning to FIG. 4 and FIG. 4A to FIG. 4D, schematic diagrams of optical paths and optical configurations for embodiments of the present laser system, laser ultrasound system, and more specifically, femto-phacoemulsification system are shown.
光學系統430具有四個光學系統400、401、402、403，其可以具有不同波長及功率且用於不同目的之光。光學系統400係用於治療雷射束，並且包含光學部件，以及定義治療雷射束所沿著行進的治療雷射束路徑。光學系統403係用於圖像及位置決定設備（例如，沙姆裝置），其決定眼睛的結構的形狀及位置，並且與治療雷射束及雷射束路徑直接相關。光學系統401係用於相機（較佳為IR相機），從圖式中可以看出，此束路徑係沿著治療雷射束路徑400行進（亦即，重合），而在該路徑的大部分中行進。兩個路徑在束分離器處組合，而用於治療雷射的Vario（Z軸雷射偏轉光學裝置）並非相機束路徑401的一部分。光學系統402係用於第二相機（較佳為彩色相機）。此系統共享一些治療雷射束路徑。Optical system 430 includes four optical systems 400, 401, 402, and 403, which can be used to transmit light of different wavelengths and powers for different purposes. Optical system 400 is used for the therapeutic laser beam and includes optical components and defines the therapeutic laser beam path along which the therapeutic laser beam travels. Optical system 403 is used for an imaging and position determination device (e.g., a Sham device), which determines the shape and position of structures of the eye and is directly related to the therapeutic laser beam and the laser beam path. Optical system 401 is used for a camera (preferably an IR camera), which, as can be seen in the figure, travels along (i.e., coincides with) the therapeutic laser beam path 400 for most of the path. The two paths are combined at the beam splitter, and the Vario (Z-axis laser deflection optics) for the treatment laser is not part of the camera beam path 401. Optical system 402 is used for a second camera (preferably a color camera). This system shares some of the treatment laser beam path.
這些光學系統400、401、402、403的區段或部分可以位於或容納在雷射系統的實施例以及雷射超音波系統及毫微微微超音波乳化系統的實施例的各種殼體及部件中。因此，藉由省略圖示，如第4圖所示，光學系統的部分可以容納或包含在遠側殼體420（例如，第5圖的殼體503或第1圖的殼體106）、臂421（例如，第3圖的臂201、第5圖的504的光管路、或第1圖的臂107）、及雷射頭或近側殼體423（例如，近側組件或雷射頭）（例如，第1圖中的臂107的近端、第2圖中的頭202、或第5圖中的頭505）。這些光學系統400、401、402、403亦可以分佈在遠側殼體420a、臂、或連接器421a與近側殼體（例如，近側組件或雷射頭423a）之間並容納於其中，如第4E圖的配置所示。這些光學系統400、401、402、403亦可以分佈在遠側殼體420b、臂421b與近側殼體423b（例如，近側組件或雷射頭）之間並容納於其中，如第4F圖的配置所示。亦可以考慮這些光學系統的其他分佈及包含或容納佈置。Segments or portions of these optical systems 400, 401, 402, and 403 can be located or housed in various housings and components of embodiments of laser systems, as well as embodiments of laser ultrasound systems and femto-emulsification systems. Thus, by omitting illustration, as shown in FIG4 , portions of the optical system can be housed or contained in a distal housing 420 (e.g., housing 503 of FIG5 or housing 106 of FIG1 ), an arm 421 (e.g., arm 201 of FIG3 , light pipe 504 of FIG5 , or arm 107 of FIG1 ), and a laser head or proximal housing 423 (e.g., a proximal assembly or laser head) (e.g., the proximal end of arm 107 of FIG1 , head 202 of FIG2 , or head 505 of FIG5 ). These optical systems 400, 401, 402, and 403 can also be distributed between and housed within the distal housing 420a, arm, or connector 421a, and the proximal housing (e.g., a proximal assembly or laser head 423a), as shown in the configuration of FIG. 4E These optical systems 400, 401, 402, and 403 can also be distributed between and housed within the distal housing 420b, arm 421b, and the proximal housing 423b (e.g., a proximal assembly or laser head), as shown in the configuration of FIG. 4F Other distributions and arrangements for the optical systems are also contemplated.
轉至第4G圖，可以見到光學系統430具有四個瞳孔461、462、463、464。在此實施例中，瞳孔係為共軛遠心瞳孔。應注意，在四個瞳孔中，只有三個沿著治療雷射束路徑。Turning to FIG. 4G , it can be seen that the optical system 430 has four pupils 461, 462, 463, and 464. In this embodiment, the pupils are concentric telecentric pupils. It should be noted that of the four pupils, only three are along the path of the treatment laser beam.
實例3AExample 3A
實例3的實施例具有與治療雷射重合的用於照亮眼睛的結構的掃描雷射，而使得來自403的光學部件等可以拍攝圖像，以知道眼睛的結構位於何處。此外，存在直射眼睛的光源，以在對接處理期間有助於針對患者的直射。針對此光的直射光源及路徑係經由第4G圖中的位於402與403之間的束分離立方體進行。The embodiment of Example 3 includes a scanning laser that illuminates the structures of the eye, overlapping with the treatment laser. This allows the optical components from 403 to capture images to determine the location of the eye's structures. Furthermore, a light source is provided that shines directly into the eye to facilitate directing the patient during the docking treatment. The directing source and path of this light is provided via the beam splitter cube located between 402 and 403 in Figure 4G.
實例4AExample 4A
毫微微超音波乳化系統具有圖像及位置決定設備，圖像及位置決定設備係為基於超音波的成像系統。在一個實施例中，圖像及位置決定設備係為光學同調斷層掃描（OCT）系統，其可以決定相對於治療雷射及治療雷射束的水晶體的結構及眼睛的結構的形狀及位置。OCT系統係與雷射子系統控制系統、超音波乳化子系統控制系統、毫微微超音波乳化系統控制系統、及這些的組合及變化進行整合及控制通訊。The femto-phacoemulsification system includes an imaging and position determination device, which is an ultrasound-based imaging system. In one embodiment, the imaging and position determination device is an optical coherence tomography (OCT) system, which can determine the shape and position of the lens and other structures of the eye relative to the therapeutic laser and the therapeutic laser beam. The OCT system is integrated and communicates with the laser subsystem control system, the phacoemulsification subsystem control system, the femto-phacoemulsification system control system, and any combinations and variations of these.
亦可以在例如第1圖、第2圖、第3圖、第5圖、第14圖的實施例以及其他實施例中使用OCT系統。The OCT system may also be used in the embodiments of, for example, FIG. 1 , FIG. 2 , FIG. 3 , FIG. 5 , and FIG. 14 , as well as in other embodiments.
實例4BExample 4B
第1圖、第2圖、第3圖、第5圖、第14圖的實施例具有並使用沙姆相機系統，以作為其圖像及位置決定設備。沙姆相機系統係為與OCT系統完全不同的系統。沙姆相機的操作方式非常不同、功能不同、並且提供與OCT系統非常不同的輸出（例如，結果）。認為本發明的沙姆系統在決定眼睛結構的位置及形狀方面優於OCT。The embodiments of Figures 1, 2, 3, 5, and 14 include and utilize a Sham camera system as their image and position determination device. A Sham camera system is a fundamentally different system from an OCT system. Sham cameras operate in a very different manner, function differently, and provide very different outputs (e.g., results) than OCT systems. The Sham system of the present invention is believed to be superior to OCT in determining the position and shape of ocular structures.
沙姆相機系統係與雷射子系統控制系統、超音波乳化子系統控制系統、毫微微超音波乳化系統控制系統、及這些的組合及變化進行整合及控制通訊。The Sham camera system is integrated and communicates with the laser subsystem control system, the phacoemulsification subsystem control system, the femtophacoemulsification system control system, and their combinations and variations.
實例5AExample 5A
在毫微微超音波乳化系統的實施例中，超音波晶體乳化子系統具有整合Peristaltic及Venturi泵的系統的下列部件及特徵，而允許外科醫生獨立選擇用於超音波乳化或玻璃體切除程序的泵模式。此超音波乳化子系統的特點包括：雙泵系統（Peristaltic及Venturi）；高真空閉塞；高速玻璃體切除。超音波乳化子系統能夠執行下列程序：電療、沖洗、雕刻、拍打及切細、切除、黏合。使用者介面及軟體針對這些及其他超音波乳化程序提供選單項目及監視欄位。In one embodiment of the femto-phacoemulsification system, the phacoemulsification subsystem incorporates the following components and features of a system integrating Peristaltic and Venturi pumps, allowing the surgeon to independently select the pump mode for either phacoemulsification or vitrectomy procedures. Features of this phacoemulsification subsystem include: a dual pump system (Peristaltic and Venturi); high vacuum shutoff; and high-speed vitrectomy. The phacoemulsification subsystem is capable of performing the following procedures: electrotherapy, irrigation, sculpting, tapping and thinning, excision, and gluing. The user interface and software provide menu items and monitoring fields for these and other phacoemulsification procedures.
實例5BExample 5B
在毫微微超音波乳化系統的實施例中，超音波晶體乳化子系統具有來自Alcon CENTURION®視覺系統、Alco ACTIVE SENTRY®手持件、及INTREPID®混合件的部件。In an embodiment of the femto-phacoemulsification system, the phacoemulsification subsystem has components from the AlconCENTURION® vision system, the Alco ACTIVESENTRY® handpiece, and theINTREPID® hybrid.
實例5CExample 5C
在毫微微超音波乳化系統的實施例中，超音波晶體乳化子系統具有來自AMO WHITESTAR SIGNATURE®PRO超音波晶體乳化系統的部件。In an embodiment of the femtophacoemulsification system, the phacoemulsification subsystem has components from the AMO WHITESTARSIGNATURE® PRO phacoemulsification system.
實例6Example 6
在雷射超音波系統（特定為毫微微超音波系統）的實施例中，系統具有安全互鎖。安全互鎖較佳地位於共同控制系統中，但是可以位於雷射控制系統、超音波乳化控制系統、及這些的組合及變化中，或者作為一部分。安全互鎖可以在超音波乳化系統操作時防止治療雷射被擊發。在較佳實施例中，互鎖系統具有三個階段或閘：（i）超音波乳化系統被關閉：可以操作雷射；（ii）超音波乳化系統被打開，並且正在預熱，但並非可操作狀態或者正在操作：可以操作雷射；以及（iii）超音波乳化在可操作狀態中或正在操作：無法擊發雷射。In an embodiment of a laser ultrasound system (particularly a femtoultrasound system), the system has a safety interlock. The safety interlock is preferably located in a common control system, but may be located in or as part of a laser control system, a phacoemulsification control system, or combinations and variations of these. The safety interlock prevents the treatment laser from being fired while the phacoemulsification system is operating. In a preferred embodiment, the interlock system has three stages or gates: (i) the phacoemulsification system is off: the laser can be operated; (ii) the phacoemulsification system is on and is warming up, but not in an operational state or in operation: the laser can be operated; and (iii) the phacoemulsification system is in an operational state or in operation: the laser cannot be fired.
在實施例中，階段（iii）在超音波乳化系統在可操作狀態中但並非正在操作時允許操作雷射。在此實施例中，僅當超音波乳化系統正在操作（亦即，遞送超音波能量）時，才鎖定治療雷射（亦即，無法擊發或傳播雷射束）。In one embodiment, stage (iii) allows operation of the laser while the phacoemulsification system is in an operable state but not operating. In this embodiment, the treatment laser is locked (i.e., unable to fire or transmit the laser beam) only when the phacoemulsification system is operating (i.e., delivering ultrasound energy).
實例7Example 7
轉至第5圖，圖示毫微微雷射裝置或系統500的透視圖。系統具有下部或主殼體501（在圖式中僅部分圖示）。下部殼體501包含超音波乳化系統、超音波乳化藥筒的位置、及程序期間的藥筒、用於產生治療雷射束的治療雷射、及控制系統。滑動機構502係位於主殼體501中。滑動機構502提供上部殼體或可移動殼體503的移動。可移動殼體503藉由滑動機構502沿著箭頭502a的方向（亦即橫向、水平、或朝內及朝外）朝向及遠離患者。Turning to FIG. 5 , a perspective view of a femtolaser device or system 500 is shown. The system has a lower or main housing 501 (only partially shown in the figure). Lower housing 501 contains the phacoemulsification system, a location for phacoemulsification cartridges and the cartridges used during procedures, a therapeutic laser for generating the therapeutic laser beam, and a control system. Sliding mechanism 502 is located within main housing 501. Sliding mechanism 502 provides movement of upper or movable housing 503. Movable housing 503 is moved toward and away from the patient by sliding mechanism 502 in the direction of arrow 502a (i.e., laterally, horizontally, or inwardly and outwardly).
滑動機構可以例如藉由例如操縱桿所控制的馬達自動移動，可以手動移動，以及利用這些的組合進行移動（例如，在馬達可以空轉的情況下）。馬達可以具有設定或預先決定的位置，並且亦可以與智慧型頭枕進行控制通訊，以將雷射遞送頭505精確地放置或定位在患者頭枕上方，並藉此可以針對患者及患者的眼睛進行操作。The slide mechanism can be moved automatically, for example, by a motor controlled by a joystick, manually, or by a combination of these (e.g., where the motor can be idle). The motor can have a set or predetermined position and can also communicate with the smart headrest to precisely position or locate the laser delivery head 505 above the patient's headrest, thereby allowing operation with respect to the patient and the patient's eyes.
上部或可移動殼體503包含雷射聚焦z方向光學裝置、xy掃描光學裝置、及其他束處理或操控部件。殼體503亦可以包含其他光學系統及光學路徑，如實例3所示。The upper or removable housing 503 contains the laser focusing z-direction optics, xy scanning optics, and other beam processing or manipulation components. Housing 503 may also contain other optical systems and optical paths, as shown in Example 3.
殼體503藉由鉸接的光管路507與治療雷射進行光學通訊。鉸接的光管路提供自由空間雷射束路徑，自由空間雷射束路徑將雷射束從下部殼體501引導至殼體503，並將治療雷射束沿著雷射束路徑遞送至殼體503中的光學部件。在此實施例中，如第5I圖更詳細所圖示，鉸接的光管路507具有六個接頭，其中每一接頭的內側具有反射表面。較佳地，在殼體503的所有可能的位置及定向上，光管路507使治療雷射及殼體501與殼體503及該殼體中的光學部件保持光學通訊。Housing 503 is in optical communication with the therapeutic laser via an articulated light pipe 507. The articulated light pipe provides a free-space laser beam path that guides the laser beam from lower housing 501 to housing 503 and delivers the therapeutic laser beam along the laser beam path to the optical components within housing 503. In this embodiment, as shown in more detail in FIG. 5I , articulated light pipe 507 has six connectors, each of which has a reflective surface on its inner side. Preferably, light pipe 507 maintains optical communication between the therapeutic laser and housing 501, housing 503, and the optical components within the housing, in all possible positions and orientations of housing 503.
殼體503具有臂504，臂504係為剛性空心光管路，而容納或包含一或更多個光學路徑（包括治療雷射束路徑，以及如實例3所述的其他路徑）。臂504利用雷射遞送頭505連接殼體503，並使這些部件保持光學通訊。臂504亦可以承載控制及通訊電纜、光纖、或電線，以用於在雷射頭的部件與控制系統之間發送控制並形成控制。雷射頭505係位於臂504的近端，而殼體503係位於臂504的遠端。Housing 503 has an arm 504, which is a rigid, hollow optical conduit that houses or contains one or more optical pathways (including the therapeutic laser beam pathway, as well as other pathways described in Example 3). Arm 504 connects to housing 503 via a laser delivery head 505, enabling these components to maintain optical communication. Arm 504 can also carry control and communication cables, optical fibers, or electrical wires, used to transmit and control laser head components to the control system. Laser head 505 is located at the proximal end of arm 504, while housing 503 is located at the distal end of arm 504.
雷射頭具有位置及形狀決定設備506，位置及形狀決定設備506係為沙姆裝置，並具有五個相機。（在實施例中，存在六個固定相機。在實施例中，存在單一可移動相機。）The laser head has a position and shape determination device 506, which is a Sham device and has five cameras. (In one embodiment, there are six fixed cameras. In another embodiment, there is a single movable camera.)
實例8Example 8
轉至第5A圖至第5H圖，圖示與第5圖的系統一起使用的位置調整機構的各種視圖及實施例（相同數字具有相同含義並指稱相同部件）。Turning to Figures 5A to 5H, various views and embodiments of a position adjustment mechanism for use with the system of Figure 5 are shown (like numbers have like meanings and refer to like parts).
轉至第5A圖，位置調整機構510通常定位於殼體503的遠離臂507的另一側。機構510的一部分可以位於殼體503下方以及在殼體501上或在殼體501中。5A , position adjustment mechanism 510 is typically located on the other side of housing 503 from arm 507. A portion of mechanism 510 may be located below housing 503 as well as on or within housing 501.
第5B圖圖示橫向移動組件531，橫向移動組件531係為位置調整機構510的一部分。橫向移動組件531具有藉由驅動齒輪或輪而與馬達523及522可移動地機械關聯的第一板520及第二板521。板520、521係以弧形方式移動，弧形方式轉換成用於固定柱512的橫向移動（亦即，沿著箭頭502a的方向）。固定柱512係附接至自由移動組件（例如，組件513）。橫向移動組件531係與殼體501機械關聯，並且可以容納在殼體501上，而較佳為容納在殼體501內。FIG5B illustrates lateral movement assembly 531, which is part of position adjustment mechanism 510. Lateral movement assembly 531 includes a first plate 520 and a second plate 521 that are movably mechanically coupled to motors 523 and 522 via drive gears or wheels. Plates 520 and 521 move in an arcuate pattern, which translates into lateral movement of fixed column 512 (i.e., in the direction of arrow 502a). Fixed column 512 is attached to a freely movable assembly (e.g., assembly 513). Lateral movement assembly 531 is mechanically coupled to housing 501 and can be housed on, but preferably within, housing 501.
實例9Example 9
轉至第5C圖，圖示具有四桿連桿機構的橫向移動組件511，四桿連桿機構係為位置調整機構510a的一部分；以及提供沿著箭頭502a的方向的移動。橫向移動組件511係與殼體501機械關聯，並且可以容納在殼體501上，而較佳為容納在殼體501內。Turning to FIG. 5C , a lateral movement assembly 511 having a four-bar linkage is shown. The four-bar linkage is part of the position adjustment mechanism 510a and provides movement in the direction of arrow 502a. The lateral movement assembly 511 is mechanically associated with the housing 501 and can be housed on the housing 501, but is preferably housed within the housing 501.
應理解，實例8的橫向移動組件510可以與實例9的位置調整機構510a一起使用，而反之亦然。應理解，自由移動組件513可以與橫向移動組件511或橫向移動組件531一起使用。應理解，亦可以使用其他自由移動型機械及機電裝置以及橫向型移動機械及機電裝置。It should be understood that the lateral movement assembly 510 of Example 8 can be used with the position adjustment mechanism 510a of Example 9, and vice versa. It should be understood that the free movement assembly 513 can be used with the lateral movement assembly 511 or the lateral movement assembly 531. It should be understood that other free movement type mechanical and electromechanical devices and lateral movement type mechanical and electromechanical devices can also be used.
組件511係附接至固定柱512。該組件沿著箭頭502a的方向移動固定柱502。固定柱512係連接至自由移動組件513。自由移動組件513利用弧形方式、橫向方式、垂直方式、及這些的組合提供殼體503的移動（如箭頭513a的集合通常所示）。組件513係為平行四邊形連桿機構。Assembly 511 is attached to fixed post 512. This assembly moves fixed post 502 in the direction of arrow 502a. Fixed post 512 is connected to free-motion assembly 513. Free-motion assembly 513 provides movement of housing 503 in arcuate, lateral, vertical, and combinations thereof (as generally indicated by the collection of arrows 513a). Assembly 513 is a parallelogram linkage mechanism.
組件513可以是電動的，可以具有預先決定的位置，或者可以利用手進行操作（例如，握住臂504、殼體503、或其他部分，並改變殼體503的位置）。在實施例中，殼體503、臂504、及雷射頭505保持平衡，而使得殼體503可以利用少於10磅的力、少於7磅的力、少於5磅的力、少於2磅的力、約2至約7磅的力、約4至約6磅的力、及這些的組合及變化進行移動。較佳地，一旦移動，則殼體503將保持在所放置的位置上，直到受到足夠的力作用，以進行移動。（為簡單起見，在第5C圖中未圖示臂504及雷射頭505）Assembly 513 may be electrically powered, may have predetermined positions, or may be manually operable (e.g., by grasping arm 504, housing 503, or other portion and changing the position of housing 503). In embodiments, housing 503, arm 504, and laser head 505 are balanced so that housing 503 can be moved using less than 10 pounds of force, less than 7 pounds of force, less than 5 pounds of force, less than 2 pounds of force, about 2 to about 7 pounds of force, about 4 to about 6 pounds of force, and combinations and variations thereof. Preferably, once moved, housing 503 remains in its positioned position until sufficient force is applied to cause it to move. (For simplicity, arm 504 and laser head 505 are not shown in FIG. 5C .)
第5D圖至第5H圖圖示自由移動組件513可以放置殼體503。第5H圖的位置係為用於系統的儲存及手術室的清潔的概念。第5E圖的位置係用於針對患者進行雷射操作。Figures 5D to 5H illustrate how the free-moving assembly 513 can be placed in the housing 503. The position in Figure 5H is for storage of the system and cleaning of the operating room. The position in Figure 5E is for laser operation on the patient.
實例10Example 10
在實施例中，雷射超音波系統（更特定為毫微微超音波乳化系統）具有附接至系統的患者床或支撐件。In an embodiment, a laser ultrasound system, and more particularly a femto-phacoemulsification system, has a patient couch or support attached to the system.
實例11Example 11
在實施例中，患者支撐件（例如，床）並未附接至雷射超音波系統（更特定為毫微微超音波乳化系統）。患者支撐件與毫微微超音波乳化系統可以完全相對於彼此進行定位，兩者之間沒有物理限制。因此，毫微微超音波乳化系統可以相對於患者支撐件而定位在任何位置或定向上（前提是患者的頭部係位於臂及超音波乳化管的範圍內）。使用A/C電磁場、陀螺儀、加速度計、及磁力計的定向/定位追蹤系統係用於決定相對於治療雷射及治療雷射束路徑的患者的頭部的定向。此定向追蹤系統可以將臂（例如，第5圖的系統的臂504）的角度決定在±5度、±3度、±2度、及更大及更小的精確度內。使用此角度，較佳地藉由控制系統來調整治療雷射束遞送圖案，以利用正確的患者眼睛的定向角度來遞送雷射束圖案。In an embodiment, a patient support (e.g., a bed) is not attached to the laser ultrasound system (more specifically, the femto-phacoemulsification system). The patient support and femto-phacoemulsification system can be positioned completely relative to each other, with no physical constraints between them. Therefore, the femto-phacoemulsification system can be positioned in any position or orientation relative to the patient support (provided the patient's head is within the range of the arm and the phacoemulsification tube). An orientation/position tracking system using an A/C electromagnetic field, gyroscopes, accelerometers, and magnetometers is used to determine the orientation of the patient's head relative to the treatment laser and the path of the treatment laser beam. This orientation tracking system can determine the angle of the arm (e.g., arm 504 of the system of FIG. 5 ) to an accuracy of ±5 degrees, ±3 degrees, ±2 degrees, or greater. Using this angle, the therapeutic laser beam delivery pattern is preferably adjusted by a control system to deliver the laser beam pattern with the correct orientation angle for the patient's eye.
在實施例中，Polhemus Patriot™ 6-DOF追蹤感測器係位於患者頭枕中，其中發射器係安裝在遞送系統的前方附近的系統框架上。此舉提供足夠的資訊來決定相對於雷射遞送系統的頭枕的定向。在附錄A中進一步描述此定向/定位追蹤系統，其全部揭示內容藉由引用併入本文。In one embodiment, a Polhemus Patriot™ 6-DOF tracking sensor is located in the patient's headrest, with the transmitter mounted on the system frame near the front of the delivery system. This provides sufficient information to determine the orientation of the headrest relative to the laser delivery system. This orientation/positioning tracking system is further described in Appendix A, the entire disclosure of which is incorporated herein by reference.
實例12Example 12
電磁追蹤系統係用於不具有超音波乳化子系統的獨立式治療雷射系統。獨立式治療雷射系統具有未附接至雷射系統的患者支撐件。電磁追蹤系統決定患者的眼睛與雷射系統的定向的角度。雷射系統將雷射遞送圖案配置成滿足所決定的角度。The electromagnetic tracking system is used with a standalone therapeutic laser system that does not have a phacoemulsification subsystem. Standalone therapeutic laser systems have a patient support that is not attached to the laser system. The electromagnetic tracking system determines the angle between the patient's eye and the orientation of the laser system. The laser system then configures the laser delivery pattern to meet this determined angle.
實例13Example 13
實例11及12的系統在患者支撐件與治療系統之間具有柔性或可定位的機械附件。電磁追蹤系統用於決定患者的眼睛與治療系統之間的位置（更特定為角度）。雷射系統將雷射遞送圖案配置成滿足所決定的角度。The systems of Examples 11 and 12 include a flexible or positionable mechanical attachment between a patient support and a treatment system. An electromagnetic tracking system is used to determine the position (more specifically, the angle) between the patient's eye and the treatment system. A laser system configures the laser delivery pattern to satisfy the determined angle.
實例14Example 14
電磁追蹤系統的部件（例如，陀螺儀、加速度計、及磁力計）利用各種佈置方式佈置在患者支撐件中、在患者頭部支撐件中、在患者自身上、及在治療系統中，其中陀螺儀、加速度計、磁力計係位於這些部件的一或更多者中。Components of the electromagnetic tracking system (e.g., gyroscopes, accelerometers, and magnetometers) are arranged in a variety of arrangements in a patient support, in a patient head support, on the patient himself, and in a treatment system, with the gyroscope, accelerometer, or magnetometer being located in one or more of these components.
實例15Example 15
在實施例中，裝置（例如，陀螺儀、加速度計、及數位羅盤）的組合係位於患者頭枕中，並且兩個磁力計係定位於毫微微超音波乳化系統中。這提供足夠的裝置來決定定向（例如，患者與雷射臂、雷射束的路徑、及圖案的角度）。In one embodiment, a combination of devices (e.g., a gyroscope, an accelerometer, and a digital compass) is located in the patient's headrest, and two magnetometers are positioned in the femto-phacoemulsification system. This provides sufficient means to determine orientation (e.g., the angle of the patient to the laser arm, the path of the laser beam, and the pattern).
使用陀螺儀、加速度計、及磁力計的基於羅盤的位置決定系統來決定患者頭部（更特定為相對於治療雷射及治療雷射束路徑的正要進行手術的眼睛）的位置。此基於羅盤的定位系統可以將臂（例如，第5圖的系統的臂504）的角度決定在±5度、±3度、±2度、及更大及更小的精確度內。使用此角度，較佳地藉由控制系統來調整治療雷射束遞送圖案，以利用正確的患者眼睛的定向角度來遞送雷射束圖案。A compass-based position determination system using gyroscopes, accelerometers, and magnetometers is used to determine the position of the patient's head (more specifically, the eye being operated on) relative to the therapeutic laser and the path of the therapeutic laser beam. This compass-based positioning system can determine the angle of an arm (e.g., arm 504 of the system of FIG. 5 ) to an accuracy of ±5 degrees, ±3 degrees, ±2 degrees, or greater. Using this angle, the therapeutic laser beam delivery pattern is preferably adjusted by a control system to deliver the laser beam pattern at the correct orientation angle for the patient's eye.
在實施例中，陀螺儀及加速度計係位於患者頭枕中，並且兩個磁力計係定位於毫微微超音波乳化系統中。這提供足夠的裝置來決定定向（例如，患者與雷射臂、雷射束的路徑、及圖案的角度）。In one embodiment, a gyroscope and accelerometer are located in the patient's headrest, and two magnetometers are positioned in the femto-phacoemulsification system. This provides sufficient means to determine orientation (e.g., patient to laser arm, laser beam path, and pattern angle).
基於羅盤的位置決定系統的部件（例如，陀螺儀、加速度計、及磁力計）利用各種佈置方式佈置在患者支撐件中、在患者頭部支撐件中、在患者自身上、及在治療系統中，其中陀螺儀、加速度計、磁力計係位於這些部件的一或更多者中。Components of the compass-based position determination system (e.g., gyroscopes, accelerometers, and magnetometers) are arranged in a variety of arrangements in a patient support, in a patient head support, on the patient themselves, and in a treatment system, with the gyroscope, accelerometer, magnetometer being located in one or more of these components.
實例11及12的系統在患者支撐件與治療系統之間具有柔性或可定位的機械附件。基於羅盤的位置決定系統用於決定患者的眼睛與治療系統之間的位置（更特定為角度）。雷射系統將雷射遞送圖案配置成滿足所決定的角度。The systems of Examples 11 and 12 include a flexible or positionable mechanical attachment between a patient support and a treatment system. A compass-based position determination system is used to determine the position (more specifically, the angle) between the patient's eye and the treatment system. The laser system configures the laser delivery pattern to satisfy the determined angle.
基於羅盤的位置決定系統係用於不具有超音波乳化子系統的獨立式治療雷射系統。獨立式治療雷射系統具有未附接至雷射系統的患者支撐件。基於羅盤的位置決定系統決定患者的眼睛與雷射系統的定向的角度。雷射系統將雷射遞送圖案配置成滿足所決定的角度。A compass-based position determination system is used with a standalone therapeutic laser system that does not have a phacoemulsification subsystem. Standalone therapeutic laser systems have a patient support that is not attached to the laser system. The compass-based position determination system determines the angle between the patient's eye and the orientation of the laser system. The laser system then configures the laser delivery pattern to meet the determined angle.
實例16Example 16
追蹤系統（例如，電磁追蹤系統）的頭枕或其他遠端部件（亦即，並非治療系統的一部分）具有可充電電池，而可以在單獨的充電站處、儲存容器、或在治療系統上進行充電。A headrest or other remote component of a tracking system (e.g., an electromagnetic tracking system) (i.e., not part of the treatment system) has a rechargeable battery that can be charged at a separate charging station, storage container, or on the treatment system.
實例17Example 17
在毫微微超音波乳化系統的實施例中，控制系統推薦（例如，匹配）白內障等級、雷射功率及圖案、超音波速率、功率、相位角度、及與手持件操作相關聯的其他態樣。以此方式，系統推薦並預先決定遞送至眼睛的所有能量，作為完全整合裝置的治療的一部分。在實施例中，藉由系統控制器來調諧水晶體乳化手持件，以依據先前的雷射程序來最佳化水晶體乳化程序，該先前的雷射程序又依據先前的白內障等級。系統提供單一系統，該單一系統能夠快速且不需要患者或系統的位置的移動來決定角膜的結構（例如，前及後表面）、眼睛的水晶體（例如，前囊、後囊）的形狀及位置，針對白內障的類型或密度進行分級，針對水晶體執行雷射囊切開及雷射碎裂，然後針對經雷射碎裂的水晶體材料執行超音波晶體乳化，以移除該材料來插入IOL。系統經配置以使用從該程序的每一先前步驟所取得的資訊來最佳化該程序的下一個步驟。以此方式，該系統在眼科程序期間向眼睛提供完全整合及預先決定的總能量遞送以及能量遞送分佈曲線。在實施例中，總能量遞送與能量遞送分佈曲線係基於所治療的白內障的等級。總能量遞送與能量遞送分佈曲線包括雷射能量及超音波能量。In an embodiment of a femto-phacoemulsification system, a control system recommends (e.g., matches) cataract grade, laser power and pattern, ultrasound rate, power, phase angle, and other aspects associated with handpiece operation. In this way, the system recommends and predetermines all energies delivered to the eye as part of a fully integrated device treatment. In an embodiment, the phacoemulsification handpiece is tuned by the system controller to optimize the phacoemulsification procedure based on a previous laser procedure, which in turn is based on a previous cataract grade. The system provides a single system that can quickly and without requiring movement of the patient or the system, determine the structure of the cornea (e.g., anterior and posterior surfaces), the shape and position of the eye's lens (e.g., anterior capsule, posterior capsule), grade the type or density of the cataract, perform laser capsulotomy and laser fragmentation of the lens, and then perform ultrasonic phacoemulsification of the laser-fragmented lens material to remove the material for insertion of an IOL. The system is configured to use information obtained from each previous step of the procedure to optimize the next step of the procedure. In this way, the system provides a fully integrated and predetermined total energy delivery and energy delivery profile to the eye during the ophthalmic procedure. In one embodiment, the total energy delivery and energy delivery profile are based on the grade of cataract being treated. The total energy delivery and energy delivery profile include laser energy and ultrasound energy.
實例18Example 18
在實施例中，毫微微超音波乳化系統針對提供程序的外科醫生或從業者提供預先決定可變模式。因此，在此模式下，與雷射控制器系統及超音波晶體乳化控制系統協同工作的系統可以預先決定並可取得用於超音波晶體乳化程序的推薦且較佳的最佳化範圍及設定。此實施例可以進一步基於外科醫生的選擇及偏好來「學習」，以基於外科醫生的實踐及輸入來提供客製化的最佳範圍。In one embodiment, the femtophacoemulsification system offers a pre-determined, variable mode for the surgeon or practitioner providing the procedure. Thus, in this mode, the system, working in conjunction with the laser controller system and the phacoemulsification control system, can pre-determine and access recommended and optimal ranges and settings for the phacoemulsification procedure. This embodiment can further "learn" based on the surgeon's choices and preferences, providing customized optimal ranges based on the surgeon's practice and input.
實例19Example 19
在實施例中，毫微微超音波乳化系統提供可調整模式，以提供更多可變性及預先決定可變性（例如，藉由基於遞送至水晶體的雷射束圖案或雷射治療、較佳為藉由系統決定或可以提供至系統的白內障等級、及其他因素而提供超音波的調整範圍的系統）。然後，系統可以針對程序提供推薦範圍及調整，其中包括：（i）扭轉橫向運動、橫跨橫向運動、或無橫向運動的推薦；（ii）增加碎裂的雷射圖案的推薦，而因此降低水晶體乳化功率，以管理眼睛中的熱積累；（iii）推薦的工作循環。In embodiments, a femto-phacoemulsification system provides an adjustable mode to provide greater variability and predetermined variability (e.g., by providing a range of ultrasound adjustments based on the laser beam pattern or laser treatment delivered to the lens, preferably the cataract grade determined by or provided to the system, and other factors). The system can then provide recommended ranges and adjustments for the procedure, including: (i) recommendations for torsional lateral motion, transverse lateral motion, or no lateral motion; (ii) recommendations for increasing the fragmented laser pattern, thereby reducing phacoemulsification power, to manage heat buildup in the eye; and (iii) recommended duty cycles.
工作循環與工作循環推薦可以包括例如針對模式（例如，脈衝模式）的選擇，該模式將水晶體乳化功率脈衝與休止週期交替，預設比率為50：50。這稱為50％的工作循環，因為每一完整循環包含50％的時間的開啟，然後50％的時間的關閉。可以改變此預設比率，以更改超音波能量與休止間隔的比率。舉例而言，给定40：60的比率，40％導致40毫秒的開啟，而60毫秒導致60毫秒的關閉。何時偏好較高或較低的工作循環？答案取決於手術的階段。為了雕刻水晶體核（例如，利用分治技術），外科醫生需要遞送足夠能量以能夠切割凹槽。這需要約40％至60％的工作循環。一旦外科醫生在水晶體核中放置凹槽並達到四分之一圓周的裂紋，則可以在四分之一圓周的超音波乳化輔助抽吸期間使用較低的工作循環。對於此四分之一圓周的移除，可以使用20％至40％的較低工作循環，因為抽吸的主要力係為流體，而不是超音波。Duty cycle and duty cycle recommendations can include, for example, selecting a mode (e.g., pulsed mode) that alternates phacoemulsification power pulses with rest periods, with a default ratio of 50:50. This is called a 50% duty cycle because each complete cycle consists of 50% of the time on and 50% of the time off. This default ratio can be changed to alter the ratio of ultrasound energy to rest intervals. For example, given a 40:60 ratio, 40% results in 40 milliseconds of on time, while 60 milliseconds results in 60 milliseconds of off time. When is a higher or lower duty cycle preferred? The answer depends on the stage of surgery. To carve the lens nucleus (e.g., using the divide-and-conquer technique), the surgeon needs to deliver enough energy to cut the groove. This requires a duty cycle of approximately 40% to 60%. Once the surgeon has placed the groove in the lens nucleus and achieved a quarter-circle fracture, a lower duty cycle can be used during the quarter-circle phacoemulsification-assisted aspiration. For this quarter-circle removal, a lower duty cycle of 20% to 40% can be used because the primary force of aspiration is the fluid, not the ultrasound.
實例20Example 20
在實施例中，例如當雷射切割材料的尺寸小於超音波乳化抽吸針開口的尺寸時，超音波乳化子系統僅用於分離雷射切割材料。In an embodiment, the sonication subsystem is used only to separate the laser-cut material, such as when the size of the laser-cut material is smaller than the size of the sonication aspiration needle opening.
實例21Example 21
雷射超音波系統（更特定為毫微微超音波乳化系統）具有整合顯微鏡。Laser ultrasound systems (more specifically femto-phacoemulsification systems) have an integrated microscope.
實例22Example 22
配接器係用於超音波乳化毫微微系統的殼體中，以適配或使用多個公司或類型的超音波乳化包及超音波乳化盒。配接器具有必需的硬體配接器及軟體，以提供系統的完整、有效、且經批准的操作。配接器可以是殼體的一部分，可以是殼體的單獨插入件或部件，或者可以是盒的一部分或與盒整合。The adapter is used within the Phocoemulsification Femtosystem housing to accommodate and use multiple companies and types of Phocoemulsification packs and cartridges. The adapter contains the necessary hardware and software to provide complete, effective, and approved operation of the system. The adapter can be part of the housing, a separate insert or component of the housing, or part of or integrated with the cartridge.
實例23Example 23
轉至第6圖，圖示雷射超音波系統的平面圖（更特定為經定位以用於執行雷射超音波治療程序的毫微微超音波乳化系統）的平面圖。毫微微超音波乳化系統610係利用頭側位置與頭上位置之間的角度進行定位。雷射遞送頭可以延伸至患者，以執行雷射手術，並且可以如箭頭620所示從患者移開，以進行超音波程序。頭枕612與患者支撐件613係相對於毫微微超音波乳化系統進行定位。系統與患者支撐件具有定位系統（例如，電磁定位系統），其決定相對於患者頭枕及患者的雷射系統的角度630、角度630a、或兩者。所測量的角度係為在臂的縱向軸線631與患者（更特定為由頭枕決定的患者的頭部）的縱向軸線632之間的角度。Turning to FIG. 6 , a plan view of a laser ultrasound system, more specifically a femto-phacoemulsification system positioned for performing a laser ultrasound treatment procedure, is shown. The femto-phacoemulsification system 610 is positioned using angles between a lateral position on the head and an upper position on the head. The laser delivery head can be extended toward the patient for laser procedures and can be moved away from the patient, as indicated by arrow 620, for ultrasound procedures. A headrest 612 and a patient support 613 are positioned relative to the femto-phacoemulsification system. The system and patient support have a positioning system (e.g., an electromagnetic positioning system) that determines the angle 630, angle 630a, or both, of the laser system relative to the patient's headrest and the patient. The angle measured is the angle between the longitudinal axis 631 of the arm and the longitudinal axis 632 of the patient (more specifically, the patient's head as determined by the headrest).
圖示外科醫生的三個位置，頭上641及頭側642、642。可以看出，無論外科醫生對於位置的偏好如何，雷射臂都不會干擾程序。The diagram shows the three surgeon positions, above the head 641 and to the side of the head 642, 642. As can be seen, regardless of the surgeon's preference for position, the laser arm does not interfere with the procedure.
此外，可以輕易且容易地將雷射頭重新定位以在患者的兩隻眼睛上進行並執行雷射程序，而不需要重新定位患者支撐件或毫微微超音波乳化系統的位置。Additionally, the laser head can be easily and readily repositioned to access and perform laser procedures on both eyes of the patient without the need to reposition the patient support or the femto-phacoemulsification system.
在實施例中，雷射系統可以經定位以具有約30度至約320度的角度630，以及在此範圍內的任何角度。針對此角度的唯一限制係為患者支撐件所在的區域。外科醫生能夠定位於頭上或任一頭側位置等。In an embodiment, the laser system can be positioned to have an angle 630 of about 30 degrees to about 320 degrees, as well as any angle within this range. The only limitation on this angle is the area where the patient support is located. The surgeon can position it above the head or at any side of the head, etc.
實例24Example 24
轉至第7圖，圖示這些可能配置與外科醫生位置中的幾種，所有這些都提供外科醫生的完整進出路徑。針對這些配置中之每一者，此完整進出路徑係針對患者的任一眼睛。因此，雷射超音波系統610可以位於：45度角656、90度角（亦即，頭側）855、135度角654、180度角（亦即，頭上）653、225度角852、270角度（亦即，頭側）851、及315度角650。應理解，雷射超音波系統可以位於圖式中所示的任何角度位置。因此，提供圍繞患者的眼睛中之每一者的完整定位（例如，雷射超音波系統的「時鐘形」）。Turning to FIG. 7 , several of these possible configurations and surgeon positions are illustrated, all of which provide the surgeon with complete access. For each of these configurations, this complete access is for either eye of the patient. Thus, the laser ultrasound system 610 can be positioned at: a 45-degree angle 656, a 90-degree angle (i.e., sideways) 855, a 135-degree angle 654, a 180-degree angle (i.e., overhead) 653, a 225-degree angle 852, a 270-degree angle (i.e., sideways) 851, and a 315-degree angle 650. It should be understood that the laser ultrasound system can be positioned at any of the angles shown in the figures. Thus, complete positioning around each of the patient's eyes is provided (e.g., a "clock-shaped" laser ultrasound system).
實例25Example 25
第8圖係為用於本系統的雷射遞送頭的沙姆形狀及位置決定組件的實施例。此實施例係為5相機配置，其中相機間隔40度。此放置允許系統以實例23及24的任何配置進行操作。即使在一些配置中並且針對一些患者而言，一個或兩個相機可能被阻擋，但該系統仍然進行操作並針對決定形狀及位置提供可靠的圖像。Figure 8 shows an embodiment of the Sham shape and position determination assembly of the laser delivery head used in this system. This embodiment features a five-camera configuration, with the cameras spaced 40 degrees apart. This placement allows the system to operate in any of the configurations shown in Examples 23 and 24. Even in some configurations and for some patients, where one or two cameras may be obstructed, the system still operates and provides reliable images for shape and position determination.
實例26Example 26
第9圖係為用於本系統的雷射遞送頭的沙姆形狀及位置決定組件的實施例。此實施例係為6相機配置，其中相機間隔40度。此放置允許系統以實例23及24的任何配置進行操作。即使在一些配置中並且針對一些患者而言，一個、兩個、或三個相機可能被阻擋，但該系統仍然進行操作並針對決定形狀及位置提供可靠的圖像。Figure 9 shows an embodiment of the Sham shape and position determination assembly of the laser delivery head used in this system. This embodiment features a six-camera configuration, with the cameras spaced 40 degrees apart. This placement allows the system to operate in any of the configurations of Examples 23 and 24. Even though one, two, or three cameras may be obstructed in some configurations and for some patients, the system still operates and provides reliable images for shape and position determination.
實例27 轉至第10A圖及第10B圖，圖示具有對接系統的近側雷射組件的透視圖的不同角度視圖。在第10B圖中，移除頭的外罩，而展示沙姆相機（例如，1001a）。近側雷射組件1000係附接至臂1040的近端，臂1040係為容納操作期間的治療雷射束路徑與雷射束的光管路。組件1000具有自動對接系統1010，自動對接系統1010具有驅動組件1011，驅動組件1011連接至對接環1020，對接環1020對接至PID並形成PID的一部分。對接系統1010較佳為藉由控制系統進行控制，並且可以藉由外科醫生使用操縱桿來進行全部或部分操作。控制系統亦控制對接系統的操作，並且可以具有負載感測器、速度控制、及其他安全及控制系統。Example 27Turning to Figures 10A and 10B , perspective views of a proximal laser assembly with a docking system are shown from different angles. In Figure 10B , the head housing is removed to reveal a Sham camera (e.g., 1001a). Proximal laser assembly 1000 is attached to the proximal end of arm 1040 , which houses the therapeutic laser beam path and the laser beam light pipe during operation. Assembly 1000 has an automated docking system 1010 , which includes a driver assembly 1011 , which is connected to a docking ring 1020 , which docks to and forms part of the PID. The docking system 1010 is preferably controlled by a control system and can be operated in whole or in part by the surgeon using a joystick. The control system also controls the operation of the docking system and may include load sensors, speed controls, and other safety and control systems.
實例28Example 28
用於本系統及治療中的治療雷射束的實施例具有高品質的束特性。雷射束的M2因子可以是1至約2.5、少於2、少於1.5、及少於1.2。Embodiments of the therapeutic laser beam used in the present system and treatment have high-quality beam characteristics. TheM2 factor of the laser beam can be 1 to about 2.5, less than 2, less than 1.5, and less than 1.2.
實例29Example 29
在本系統的實施例中，包括解除雷射的對接，將雷射臂移開，並使超音波乳化工具可以用於插入（在實施例中亦包括將超音波乳化工具插入眼睛）的從毫微微到超音波乳化的轉換可能需要少於5分（分鐘）、少於4分、3分及更少、2分及更少、約3至5分、約3至4分、約2分至4分、及更長或更短的時間。In embodiments of the present system, the transition from femto to phacoemulsification, including undocking the laser, moving the laser arm out of the way, and making the phacoemulsification tool available for insertion (which in embodiments also includes inserting the phacoemulsification tool into the eye), can take less than 5 minutes, less than 4 minutes, 3 minutes or less, 2 minutes or less, about 3 to 5 minutes, about 3 to 4 minutes, about 2 to 4 minutes, and longer or shorter.
實例30Example 30
在實施例中，針對具有32x22英吋的佔地面積的毫微微超音波乳化系統，床佈置自由度允許將裝置定位於6呎3吋及更短的患者周圍的任何位置。此系統提供真正靈巧的系統。此靈巧的系統可以針對外科醫生提供圍繞每一眼睛的雷射的完整時鐘形以及頭側以及頭上的方式。In an embodiment, for a femto-phacoemulsification system with a footprint of 32 x 22 inches, the couch placement freedom allows the device to be positioned anywhere around a patient 6 feet 3 inches or shorter. This provides a truly ambidextrous system that can offer the surgeon a full clockwise, lateral, and superior approach to the laser around each eye.
實例31Example 31
各種實施例（例如，實例的實施例）的與雷射系統相關的部件係用於獨立式雷射系統中，獨立式雷射系統沒有整合在一起的超音波乳化系統。The laser system-related components of various embodiments (e.g., embodiments of the present invention) are used in a stand-alone laser system that is not integrated with a phacoemulsification system.
實例32Example 32
在這些裝置的實施例中，地板區域佔地面積（亦即，由外殼體形成的裝置外殼）係為5平方英呎（22英吋x33英吋=726平方英呎/144=5平方英呎）。此裝置的高度係為57英吋至65英吋。雷射臂及其光學頭主要為水平移動。臂不會環繞樞軸點旋轉。在儲存時，臂完全適配於裝置外殼（亦即，22英吋x33英吋）內。針對標稱位置的初始設定，雷射臂及其光學頭係在「X」上行進最大的33英吋。一旦處於標稱位置，則運動平台可以在X上移動+/-2英吋，在Y上移動+/-2英吋，在Z上移動+5/-3英吋，以針對患者進行精細調整。（本實例所使用的X係為裝置的長軸，Y係為裝置的橫向軸，Z係為裝置的垂直軸。） 因此，在此實施例中，臂在X及Y上移動，而使得在儲存時手臂及其光學頭完全適配於裝置佔地面積內。殼體係為不可調整，因此其寬度及橫向尺寸不會改變。In embodiments of these devices, the floor area (i.e., the device enclosure formed by the housing) is 5 square feet (22 inches x 33 inches = 726 square feet / 144 = 5 square feet). The height of the device is 57 inches to 65 inches. The laser arm and its optical head move primarily horizontally. The arm does not rotate about its pivot point. When stored, the arm fits completely within the device enclosure (i.e., 22 inches x 33 inches). For initial setup in the nominal position, the laser arm and its optical head travel a maximum of 33 inches in the "X" direction. Once in the nominal position, the motion platform can move +/- 2 inches in X, +/- 2 inches in Y, and +5/- 3 inches in Z to make fine adjustments to the patient. (This example uses X as the device's long axis, Y as the device's lateral axis, and Z as the device's vertical axis.) Thus, in this embodiment, the arm moves in X and Y so that the arm and its optical head fit completely within the device's footprint when stored. The housing is non-adjustable so its width and lateral dimensions do not change.
實例33Example 33
轉至第14圖，圖示毫微微超音波乳化系統1400的實施例的透視圖。第15圖、第15A圖、第15B圖、第16A圖、第16B圖、第16C圖、第17A圖、第17B圖、第17C圖圖示第14圖的系統的各種部件及配置。在這些圖式中，相同數字表示相同部件。Turning to FIG. 14 , a perspective view of an embodiment of a femto-phacoemulsification system 1400 is shown. FIG. 15 , FIG. 15A , FIG. 15B , FIG. 16A , FIG. 16B , FIG. 16C , FIG. 17A , FIG. 17B , and FIG. 17C illustrate various components and configurations of the system of FIG. Like numbers represent like components throughout the drawings.
毫微微超音波乳化雷射系統1400具有用於形成系統1400的底座1403的殼體1401。移動機構殼體1402係位於底座1403上方，並附接至殼體1401。殼體1402包含用於可伸出組件1409的用於水平移動的機構（亦即，伸出及縮回）。轉換滑動平台1410係藉由水平移動機構1420伸出及縮回。轉換滑動平台1410支撐光學組件及掃描器殼體1406。此殼體1406亦包含垂直移動機構1425以及垂直移動轉換滑動平台1411。Femto-emulsification laser system 1400 includes a housing 1401 that forms the base 1403 of system 1400. A movement mechanism housing 1402 is located above base 1403 and attached to housing 1401. Housing 1402 includes a mechanism for horizontal movement (i.e., extension and retraction) of an extendable assembly 1409. A translation slide 1410 is extended and retracted via a horizontal translation mechanism 1420. Translation slide 1410 supports the optical assembly and scanner housing 1406. This housing 1406 also includes a vertical translation mechanism 1425 and a vertical translation slide 1411.
可伸出組件1409包括殼體1406、臂1407、及雷射束遞送頭1408，臂1407包含系統的各種光學路徑以及控制電纜。雷射束遞送頭1408包括形狀及位置決定設備1412及PID 1470。The extendable assembly 1409 includes the housing 1406, the arm 1407, which contains the system's various optical paths and control cables, and the laser beam delivery head 1408. The laser beam delivery head 1408 includes the shape and position determination device 1412 and the PID 1470.
在第17圖中，圖示具有一個監視器1413的系統1400。系統可以具有一個或兩個附加的監視器（如第16A圖至第16C圖所示）。系統可以具有整合顯微鏡（在這些圖式中未圖示）。In FIG. 17 , a system 1400 is shown with one monitor 1413. The system may have one or two additional monitors (as shown in FIG. 16A through FIG. 16C ). The system may have an integrated microscope (not shown in these figures).
在第15圖中，圖示附接至轉換滑動平台1410的可伸出組件1409。平台1410具有可伸出/可縮回底座1424以及柔性可伸出/可縮回外罩1422。平台1410提供組件1409的水平移動。平台1410係定位於殼體1402內，並且部分形成該殼體的頂表面。殼體1402係附接至殼體1401。FIG. 15 shows extendable assembly 1409 attached to a translating sliding platform 1410. Platform 1410 has an extendable/retractable base 1424 and a flexible extendable/retractable cover 1422. Platform 1410 provides horizontal movement of assembly 1409. Platform 1410 is positioned within housing 1402 and partially forms the top surface of the housing. Housing 1402 is attached to housing 1401.
轉至第15A圖以及第15圖，水平移動機構1420係包含在殼體1402內。機構1420可以直接附接至殼體1402、殼體1401、及這些的組合及變化。殼體1402亦包含用於托持（亦即，捲繞及鬆開）柔性外罩1422的捲軸1423。殼體1402亦包含輥1421，柔性外罩1422係在輥1421上方進行移動。Turning to Figures 15A and 15B, horizontal movement mechanism 1420 is contained within housing 1402. Mechanism 1420 can be attached directly to housing 1402, housing 1401, or combinations and variations thereof. Housing 1402 also includes a reel 1423 for supporting (i.e., winding and unwinding) a flexible cover 1422. Housing 1402 also includes a roller 1421 over which flexible cover 1422 moves.
第15A圖圖示水平移動機構1420，其中外罩1402被移除。機構1420具有馬達、驅動機構、感測器、及控制。機構1420具有水平滑動機構1426，水平滑動機構1426係為一者在另一者內側的一對滑動軌道。支撐件1428將內部軌道與垂直滑動機構1427連接，其中滑動機構形成垂直移動機構1425的一部分（參見第15圖）。第15B圖圖示處於第一伸出位置的第15A圖的軌道組件，第一伸出位置係為用於進行雷射操作的位置。FIG15A illustrates horizontal motion mechanism 1420 with housing 1402 removed. Mechanism 1420 includes a motor, drive mechanism, sensors, and controls. Mechanism 1420 includes a horizontal slide mechanism 1426, which is a pair of sliding rails positioned inside each other. Supports 1428 connect the inner rails to a vertical slide mechanism 1427, which forms part of vertical motion mechanism 1425 (see FIG15 ). FIG15B illustrates the rail assembly of FIG15A in its first extended position, which is the position for laser operation.
第16A圖係為具有3個監視器的第14圖的系統1400的平面圖。系統1400係位於手術室或患者治療室中。系統1400處於完全縮回（例如，停放）的位置。在停放位置中，可伸出組件1409不會從底座1403伸出。因此，在此位置中，可伸出組件1409不會延伸超出系統的佔地面積或外殼（虛線1480）內（亦即，完全在內側）。相對於患者床1490及人來圖示系統1400。FIG16A is a plan view of the system 1400 of FIG14 with three monitors. System 1400 is located in an operating room or patient treatment room. System 1400 is in a fully retracted (e.g., parked) position. In the parked position, extendable assembly 1409 does not extend from base 1403. Thus, in this position, extendable assembly 1409 does not extend beyond (i.e., is completely inside) the system's footprint or housing (dashed line 1480). System 1400 is illustrated relative to a patient bed 1490 and a person.
第16B圖圖示處於伸出位置（第一位置或第一伸出位置）的用於執行治療雷射操作的系統。儘管利用相對於患者90度的定向角度圖示系統，但應理解，此系統可以利用任何角度相對於患者進行定位。舉例而言，此系統可以利用實例23及24的任何角度進行定位。可伸出組件1409水平延伸超過系統的殼體，以將雷射頭定位在患者上方。FIG. 16B illustrates the system for performing therapeutic laser operations in an extended position (a first position or first extended position). Although the system is illustrated at a 90-degree orientation relative to the patient, it should be understood that the system can be positioned at any angle relative to the patient. For example, the system can be positioned at any of the angles described in Examples 23 and 24. Extendable assembly 1409 extends horizontally beyond the system housing to position the laser head above the patient.
第16C圖圖示處於完全伸出位置的用於執行治療雷射操作的系統。利用與患者成135度的定向角度來圖示系統。完全伸出的位置使系統的殼體維持距離患者足夠遠，以提供從業者與患者之間的適當、舒適、及符合人體工程學的進出路徑。可伸出組件1409水平延伸超過系統的殼體，以將雷射頭定位在患者上方。將第16C圖與第16B圖進行比較，圖示第16C圖的完全伸出位置的組件1409比第16B圖的第一伸出位置更長（亦即，雷射頭更遠離底座）。FIG. 16C illustrates the system for performing therapeutic laser operations in a fully extended position. The system is illustrated using an orientation angle of 135 degrees from the patient. The fully extended position maintains the system housing far enough from the patient to provide proper, comfortable, and ergonomic access for the practitioner and the patient. Extendable assembly 1409 extends horizontally beyond the system housing to position the laser head above the patient. Comparing FIG. 16C to FIG. 16B , assembly 1409 is shown in the fully extended position of FIG. 16C as being longer (i.e., the laser head is further from the base) than in the first extended position of FIG. 16B .
第17A圖至第17C圖係為一系列照片，展示第14圖的系統的可伸縮組件在伸出及縮回時的特定位置。第17A圖圖示用於雷射系統的測試及校準的中性伸出位置。第17B圖圖示用於治療雷射操作的第一操作伸出位置。第17C圖圖示用於治療雷射操作的第二操作伸出位置（完全伸出）。Figures 17A through 17C are a series of photographs illustrating the retractable assembly of the system of Figure 14 in specific positions during extension and retraction. Figure 17A illustrates the neutral extended position used for testing and calibration of the laser system. Figure 17B illustrates the first operational extended position for therapeutic laser operation. Figure 17C illustrates the second operational extended position (fully extended) for therapeutic laser operation.
因此，系統可以具有四個預先決定的位置。在停放位置中，雷射頭及可伸出組件係位於裝置的佔地面積內。在中間位置中，只有雷射頭水平延伸超過裝置的佔地面積。在第一伸出位置中，可以針對患者進行雷射治療活動。在第二或完全伸出位置中，可以針對患者進行雷射治療活動。可以藉由停止件、基於機械、基於控制軟體、及這些的組合及變化來控制四個預先決定的位置。系統亦可以經配置以具有從中間到完全伸出的任意數量的其他伸出長度（係為預先決定的或單獨由操作者所決定的，以及這些的組合及變化）。Thus, the system can have four predetermined positions. In the parked position, the laser head and extendable assembly are within the footprint of the device. In the intermediate position, only the laser head extends horizontally beyond the footprint of the device. In the first, extended position, laser therapy activities can be performed on the patient. In the second or fully extended position, laser therapy activities can be performed on the patient. The four predetermined positions can be controlled by stops, mechanically based, control software based, and combinations and variations of these. The system can also be configured to have any number of other extension lengths from intermediate to fully extended (either predetermined or determined solely by the operator, and combinations and variations of these).
殼體包含功率部件、控制部件、操作部件、分析預測及診斷裝置、位置決定及定位裝備、雷射束產生部件、及超音波產生部件。在較佳實施例中，超音波產生部件係為超音波晶體乳化系統的部件，而雷射束產生部件提供具有約2ps及更短的脈衝長度的雷射束。The housing contains a power supply, a control unit, an operating unit, an analysis, prediction, and diagnostic device, a position determination and positioning device, a laser beam generating unit, and an ultrasound generating unit. In a preferred embodiment, the ultrasound generating unit is a component of an ultrasonic phacoemulsification system, and the laser beam generating unit provides a laser beam with a pulse length of approximately 2 ps or less.
這些部件可能由於以下原因而全部或部分地分佈在兩個殼體1401、1402之間：為了最佳化空間，為了避免部件之間的干擾，為了管理熱及振動，以及為了提供系統1400的更有效控制及操作。兩個殼體1401、1402可以是在相同的底座或框架上的獨立殼體，可以在其間具有通訊、控制、功率、光學、及其他連接，可以是單一相同的殼體，可以細分或劃分成第三或第四等殼體或子殼體，以及這些的組合及變化。These components may be distributed, in whole or in part, between the two housings 1401, 1402 for the following reasons: to optimize space, to avoid interference between components, to manage heat and vibration, and to provide more efficient control and operation of the system 1400. The two housings 1401, 1402 may be separate housings on the same base or frame, may have communications, control, power, optical, and other connections therebetween, may be a single identical housing, may be subdivided or divided into third or fourth housings or sub-housings, and combinations and variations thereof.
連接器1505係為將殼體1401與殼體1406連接的光學導管。殼體1406包含用於治療雷射束的掃描裝置及束成形光學裝置，其中掃描裝置、光學裝置、及兩者均可以用於監視及診斷雷射束及光學路徑。（殼體1406亦包含垂直移動機構。） 應理解，在實施例中，殼體1406的這些部件可以全部或部分地位於另一殼體中的一個，並且同樣地，來自另一殼體的部件可以位於殼體1406中。殼體1406可以細分或劃分成一或更多個殼體或子殼體，以及這些的組合及變化。在當前較佳實施例中，殼體1406包含並隔離掃描器及束成形光學裝置。掃描器及束成形光學裝置或可能包含在殼體1406中的其他部件係與系統1400的控制器及操作系統進行控制通訊。裝置可以彼此直接進行控制通訊，或者可以彼此間接進行控制通訊（例如藉由與中心（例如，可能亦具有控制能力的系統1400控制器、監視器1413）進行控制通訊），以及這些的組合及變化。這些裝置亦可以彼此直接及間接進行控制通訊。Connector 1505 is an optical conduit connecting housing 1401 to housing 1406. Housing 1406 contains a scanning device and beam-shaping optics for the therapeutic laser beam, wherein the scanning device, the optics, and both can be used to monitor and diagnose the laser beam and the optical path. (Housing 1406 also contains a vertical translation mechanism.) It should be understood that in embodiments, these components of housing 1406 may be located in whole or in part in one of the other housings, and similarly, components from another housing may be located in housing 1406. Housing 1406 may be subdivided or divided into one or more housings or sub-housings, as well as combinations and variations of these. In the presently preferred embodiment, housing 1406 contains and isolates the scanner and beam-shaping optics. The scanner and beam-shaping optics, or other components that may be contained within housing 1406, are in control communication with the controller and operating system of system 1400. Devices may be in direct control communication with one another, or they may be in control communication with one another indirectly (e.g., via a central point (e.g., the system 1400 controller, which may also have control capabilities, monitor 1413), as well as combinations and variations of these. Devices may also be in control communication with one another both directly and indirectly.
光學導管1405可以是光管路（例如，具有內部反射表面的中空管或通道，而使得雷射束發射通過中空管內的自由空間，而中空管內的自由空間可以具有部分真空，具有環境中的空氣，包含惰性氣體，及這些的組合及變化）、鉸接式光管路、伸縮式光管路、柔性光管路、光纖、一或更多個光纖、中空導管、束導引器，以及這些及其他雷射束傳輸結構的組合及變化。The optical conduit 1405 can be a light pipe (e.g., a hollow tube or channel with an internal reflective surface such that the laser beam is emitted through free space within the hollow tube, wherein the free space within the hollow tube can have a partial vacuum, have ambient air, include an inert gas, and combinations and variations of these), an articulated light pipe, a telescoping light pipe, a flexible light pipe, an optical fiber, one or more optical fibers, a hollow conduit, a beam guide, and combinations and variations of these and other laser beam delivery structures.
殼體1406係附接至臂1407。臂1407及殼體1406係藉由垂直移動機構1425沿著垂直方向移動。臂1407具有用於決定眼睛的形狀及位置以及眼睛內的結構的組件或裝置1412。臂1407的近端（亦即，沿著雷射束路徑最遠的端部，而因此距離雷射束源最遠，並且位於裝置1412下方）具有患者介面裝置（PID）1470。殼體1406具有監視器1413。監視器可以在例如關節臂上移動。監視器可以提供資訊（例如，程序、系統狀況、雷射狀態、超音波狀態、白內障密度、超音波設定、雷射圖案設定），並且可以接收外科醫生的輸入及指令。監視器係與系統1400控制系統進行控制通訊，監視器亦可以包含系統1400控制系統的一部分或全部。監視器透過系統1400控制系統、透過監視器1413、及這些的組合及變化直接與雷射控制系統及超音波控制系統進行控制通訊。監視器及其關節臂可以位於系統1400中的其他結構上，亦可以單獨設置。可以使用一個、兩個、及額外的監視器。監視器可以具有3D查看或顯示功能。Housing 1406 is attached to arm 1407. Arm 1407 and housing 1406 are moved vertically by vertical translation mechanism 1425. Arm 1407 has components or devices 1412 for determining the shape and position of the eye and structures within the eye. The proximal end of arm 1407 (i.e., the end furthest along the laser beam path and therefore farthest from the laser beam source, and located below device 1412) has a patient interface device (PID) 1470. Housing 1406 has a monitor 1413. The monitor can be moved, for example, on an articulated arm. The monitor can provide information (e.g., procedures, system status, laser status, ultrasound status, cataract density, ultrasound settings, laser pattern settings) and can receive input and instructions from the surgeon. The monitor is in control communication with the system 1400 control system, and the monitor can also include part or all of the system 1400 control system. The monitor is in control communication directly with the laser control system and the ultrasound control system through the system 1400 control system, through monitor 1413, and combinations and variations of these. The monitor and its articulated arm can be located on other structures in the system 1400 or can be set separately. One, two, or additional monitors can be used. The monitor can have 3D viewing or display capabilities.
臂1407形成或包含雷射束傳輸結構（例如，中空管），以提供用於雷射束的傳送的自由空間。在實施例中，臂1407可以包含自由空間中的光束路徑，或者用於將雷射束發送至例如掃描器的光纖，光纖位於管的近端而不是遠端（亦即，靠近殼體1406的端部）。臂1407亦可以是或包含描述用於光學導管1405的類型的雷射束傳輸結構。管亦可以包含光學裝置。在第14圖的實施例中，臂1407包含非準直的雷射束，而因此臂1407可以指稱為包含非準直的雷射束及雷射束路徑，換言之，臂1407沿著雷射束路徑包含、圍繞、或容納「非準直空間」。臂1407可以容納或圍繞準直空間，準直空間係為雷射束路徑上的雷射束進行準直的空間。其可以容納包含光學裝置的空間。其可以容納準直及非準直的空間。實施例中的臂1407可以從遠端樞轉、旋轉、伸縮、鉸接、及這些的組合及變化。臂1407中的雷射束路徑的近端包含鏡或光學裝置，以將雷射束引導通過PID，並到達及進入患者的眼睛。Arm 1407 forms or includes a laser beam transmission structure (e.g., a hollow tube) that provides free space for the transmission of the laser beam. In embodiments, arm 1407 may include a beam path in free space, or an optical fiber for transmitting the laser beam to, for example, a scanner, with the optical fiber located at the proximal end of the tube rather than the distal end (i.e., near the end of housing 1406). Arm 1407 may also be or include a laser beam transmission structure of the type described for optical conduit 1405. The tube may also include optical devices. In the embodiment of FIG. 14 , arm 1407 includes a non-collimated laser beam, and thus arm 1407 may be referred to as including the non-collimated laser beam and the laser beam path. In other words, arm 1407 includes, surrounds, or accommodates "non-collimated space" along the laser beam path. Arm 1407 can contain or surround a collimation space, which is the space where the laser beam is collimated along the laser beam path. It can also contain space containing optical devices. It can accommodate both collimated and non-collimated spaces. In embodiments, arm 1407 can pivot, rotate, extend, articulate, or any combination or variation of these at the distal end. The proximal end of the laser beam path in arm 1407 contains a mirror or optical device to guide the laser beam through the PID and into the patient's eye.
實例34Example 34
在實施例中，雷射系統具有外部、內部、或兩者的冷卻。In embodiments, the laser system has external, internal, or both cooling.
實例35Example 35
轉至第12A圖至第12J圖，圖示PID（患者介面裝置），該PID係附接至本雷射超音波系統中之任一者並與其一起使用，並且亦與獨立式雷射系統一起使用。在第12A圖至第12J圖中，相同數字係對應於相同結構。如第12A圖至第12J圖所示，此實例中的PID 1200的實施例具有以下部件： 1201：PID臂 1202：上部窗口 1204：目鏡 1204a：目鏡外裙部 1204b：目鏡內裙部 1205：上部環 1206：下部環 1207a：卡扣 1207b：卡扣 1207c：卡扣 1208a：緩衝器 1208b：緩衝器 1208c：緩衝器 1209：彎月形反向器 1210：儲液環 1211：上部環側壁 1212：鹽水填充通道 1213：真空埠 1220：附接方塊 1221：臂 1221a：臂的鎖定位置 1222：接收夾具 1223：接合球 1224：狹槽（運動狹槽） 1225：用於展示臂移動的箭頭 1226：用於展示方塊接合移動的箭頭 1250：眼睛 1260：雷射超音波裝置Turning to Figures 12A to 12J, there are shown a PID (patient interface device) that is attached to and used with any of the present laser ultrasound systems, and also used with a stand-alone laser system. In Figures 12A to 12J, like numbers correspond to like structures. As shown in Figures 12A through 12J , the embodiment of the PID 1200 in this example has the following components:1201: PID arm1202: Upper window1204: Eyepiece1204a: Eyepiece outer skirt1204b: Eyepiece inner skirt1205: Upper ring1206: Lower ring1207a: Snap-on1207b: Snap-on1207c: Snap-on1208a: Buffer1208b: Buffer1208c: Buffer1209: Meniscus deflector1210: Liquid storage ring1211: Upper ring sidewall1212: Salt water filling channel1213: Vacuum port1220: Attachment block1221: Arm1221a: Locking position of the arm1222: Receiving clamp1223: Engagement ball1224: Slot (motion slot)1225: Arrow showing arm movement1226: Arrow showing block engagement movement1250: Eye1260: Laser ultrasound device
此患者介面裝置係附接至眼睛，以作為單一組件。附接至雷射頭的整個裝置係定位並接合至眼睛的表面。PID臂係藉由夾具機構附接至雷射系統。The patient interface device is attached to the eye as a single component. The entire device, attached to the laser head, is positioned and bonded to the surface of the eye. The PID arm is attached to the laser system via a clamping mechanism.
在對接期間，將PID臂的吸取杯輕輕定位於角膜表面上方，而使得吸取環與眼睛的表面接觸，然後啟動真空以限制眼睛的相對運動，藉此穩定相對於PID的位置，以進行精確的雷射治療。During docking, the suction cup of the PID arm is gently positioned over the corneal surface, bringing the suction ring into contact with the surface of the eye. The vacuum is then activated to restrict relative movement of the eye, thereby stabilizing its position relative to the PID for precise laser treatment.
PID臂上的3個球形特徵係與夾具機構上的運動狹槽特徵接合。在位置接合期間，球將彈簧力施加至PID臂。一旦PID就位，則控制桿啟動CAM機構，以將球加載到PID，並將運動安裝架進行鎖定就位。Three ball-shaped features on the PID arm engage with the kinematic slot features on the clamp mechanism. During position engagement, the balls apply spring force to the PID arm. Once the PID is in position, the control lever activates the CAM mechanism, loading the balls onto the PID and locking the kinematic mount in place.
吸取杯介面或「眼睛杯介面」覆蓋眼睛的前表面並附接至眼睛。玻璃窗口定義患者介面裝置的第一平坦表面。軟體演算法所使用的第一折射表面的位置參考係用於計算從照明或雷射束所發出的光的焦點的精確位置。The suction cup interface, or "eye cup interface," covers the anterior surface of the eye and is attached to the eye. The glass window defines the first flat surface of the patient interface device. The software algorithm uses the position reference of the first refractive surface to calculate the precise location of the focus of the light emitted from the illumination or laser beam.
3個卡扣係用於托持窗口。3個覆蓋成形緩衝器將窗口推動以緊密接合卡扣底切。PID臂的流體腔室係設計成具有向窗口的近側延伸的圓形壁。這允許在流體腔室填充期間流體彎月形在與窗口接觸之前進行反向。流體與窗口的適當接觸（亦即，從窗口的中心向外至周邊）有助於防止氣泡滯留於窗口下方，而氣泡可能會破壞雷射束。Three clips hold the window in place. Three overmolded bumpers push the window into a tight engagement with the clip undercuts. The PID arm's fluid chamber is designed with rounded walls that extend proximally toward the window. This allows the fluid meniscus to reverse during chamber filling before contacting the window. Proper fluid contact with the window (i.e., from the center of the window outward to the periphery) helps prevent air bubbles from becoming trapped beneath the window, which could disrupt the laser beam.
PID臂的流體腔室係延伸至儲液環，其中來自腔室的多餘流體被排出。這亦作為屏障，以防止腔室中的鹽溶液（BSS）接觸患者皮膚，這可能導致其藉由毛細作用而排出。The fluid chamber of the PID arm extends to a reservoir ring where excess fluid from the chamber is drained. This also acts as a barrier to prevent the saline solution (BSS) in the chamber from coming into contact with the patient's skin, which could cause it to drain out through capillary action.
PID臂在其底部具有柔性附接環，柔性附接環適於與患者的眼睛的前表面對接。附接環包括由矽樹脂製成的柔性環形外裙部及內裙部，在眼杯被固定時與眼睛的表面接合。內裙部及外裙部描繪用於真空連通通道的環形抽取通道。The PID arm has a flexible attachment ring at its base that is adapted to interface with the anterior surface of the patient's eye. The attachment ring comprises a flexible, annular outer skirt and an inner skirt made of silicone that engage the surface of the eye when the eyecup is secured. The inner and outer skirts define an annular extraction channel for vacuum communication.
在設計的其他態樣中，PID臂在其一側具有真空埠，真空埠係用於在環形抽取通道中產生抽取力，而使眼杯介面能夠整齊地附接至患者的眼睛。緊鄰第一埠的第二埠係連接到醫療級管，以利用鹽溶液（BSS）填充眼杯介面腔室。In another aspect of the design, the PID arm has a vacuum port on one side that is used to generate a suction force in the annular extraction channel, allowing the eyecup interface to be neatly attached to the patient's eye. A second port, adjacent to the first port, is connected to medical-grade tubing to fill the eyecup interface chamber with saline solution (BSS).
實例35AExample 35A
轉至第13圖，圖示PID 1300的透視圖。PID 1300具有PID臂1301、上部（遠側）窗口1302、及下部（近側）玻璃窗口1303，上部（遠側）窗口1302可以是玻璃，並且較佳為針對治療雷射具有高透射率，下部（近側）玻璃窗口1303可以是玻璃，並且較佳為針對治療雷射具有高透射率。Turning to FIG. 13 , a perspective view of PID 1300 is shown. PID 1300 has a PID arm 1301, an upper (distal) window 1302, which can be glass and preferably has high transmittance for the therapeutic laser, and a lower (near) glass window 1303, which can be glass and preferably has high transmittance for the therapeutic laser.
實例36Example 36
轉至第18圖及第19圖，分別圖示用於直射光光學組件及路徑以及沿著例如到達眼睛的治療雷射束遞送路徑的一部分的向下管路（DTP），其中光學組件及路徑係利用相機觀看眼睛。在較佳實施例中，直射光學路徑的大部分係與DTP觀看路徑重合。Turning to Figures 18 and 19, a down-pipe (DTP) for direct light optics and paths, and along a portion of a therapeutic laser beam delivery path, such as to the eye, are illustrated, respectively, where the optics and paths are used to view the eye using a camera. In a preferred embodiment, a majority of the direct light path coincides with the DTP viewing path.
應理解，在本說明書中標題的使用是為了清楚及參考之目的，而不是利用任何方式進行限制。因此，標題所描述的處理組成物及揭示內容應該結合包括各種實施例的整個說明書在上下文中進行閱讀。本說明書中的標題的使用不應限制本發明所提供的保護範圍。It should be understood that the use of headings in this specification is for purposes of clarity and reference and is not intended to be limiting in any way. Therefore, the processing compositions and disclosures described by the headings should be read in the context of the entire specification, including the various embodiments. The use of headings in this specification should not limit the scope of protection provided by the present invention.
應理解，不需要提供或解決新穎及開創性的處理、雷射操作、雷射圖案、增強及改善的視覺、或與本發明的實施例有關或相關聯的主題的其他有益特徵及性質的理論。然而，在本說明書中，提供各種理論以進一步推進該領域的技術。本說明書所提出的理論，除非另有明確說明，否則並非以任何方式限制或縮限所要求保護的發明的保護範圍。在利用本發明時，不需要或不實踐這些理論。亦應理解，本發明可以導致新的且至今未知的理論來解釋本發明的方法、雷射圖案、雷射操作、眼睛的功能、裝置、及系統的實施例的功能特徵；並且這種後來發展的理論不應限制本發明所提供的保護範圍。It is understood that no theory is required to provide or account for novel and groundbreaking processes, laser operations, laser patterns, enhanced and improved vision, or other beneficial features and properties of the subject matter related to or associated with the embodiments of the present invention. However, various theories are provided in this specification to further advance the art in this field. The theories presented in this specification, unless expressly stated otherwise, are not intended to limit or restrict the scope of protection of the claimed invention in any way. Such theories are not required or practiced in utilizing the present invention. It is also understood that the present invention may lead to new and heretofore unknown theories to explain the functional features of the embodiments of the methods, laser patterns, laser operations, eye functions, devices, and systems of the present invention; and that such later developed theories should not limit the scope of protection provided by the present invention.
除了本說明書所揭示的圖式的那些實施例之外，本說明書所闡述的裝置、系統、雷射射擊圖案、活動、及操作的各種實施例亦可以與各種測量、診斷、外科、及治療雷射系統一起使用，或與其結合使用。本說明書所闡述的裝置、系統、雷射射擊圖案、活動、及操作的各種實施例可以與下列各者一起使用：將來可能開發的其他測量、診斷、外科、及治療系統：可以部分依據本說明書的教示進行修改的現有測量、診斷、外科、及治療雷射系統；以及其他類型的測量、診斷、外科、及治療系統。此外，本說明書所闡述的裝置、系統、雷射射擊圖案、活動、及操作的各種實施例可以利用不同及各種組合彼此一起使用。因此，例如本說明書的各種實施例所提供的配置可以彼此一起使用。舉例而言，根據本說明書的教示，具有A、A'、及B的實施例的部件以及具有A''、C、及D的實施例的部件可以利用各種組合彼此一起使用（例如，A、C、D、及A、A''、C、及D等）。因此，本發明所提供的保護範圍不應限制在特定實施例、實例或特定圖式中的實施例所闡述的特定實施例、配置、或佈置中。In addition to those embodiments shown in the drawings disclosed herein, the various embodiments of the devices, systems, laser shot patterns, activities, and operations described herein can be used with or in combination with various measurement, diagnostic, surgical, and therapeutic laser systems. The various embodiments of the devices, systems, laser shot patterns, activities, and operations described herein can be used with: other measurement, diagnostic, surgical, and therapeutic systems that may be developed in the future; existing measurement, diagnostic, surgical, and therapeutic laser systems that may be modified in part based on the teachings of this specification; and other types of measurement, diagnostic, surgical, and therapeutic systems. Furthermore, the various embodiments of the devices, systems, laser firing patterns, activities, and operations described herein can be used in combination with one another in different and various combinations. Thus, for example, the configurations provided by the various embodiments of this specification can be used together. For example, according to the teachings of this specification, components of the embodiment having A, A', and B and components of the embodiment having A", C, and D can be used together in various combinations (e.g., A, C, D and A, A", C, and D, etc.). Therefore, the scope of protection provided by the present invention should not be limited to the specific embodiments, configurations, or arrangements described in a particular embodiment, example, or embodiment in a particular figure.
在不悖離本發明的精神或基本特徵的情況下，可以利用不同於本文所具體揭示的其他形式來實施本發明。所描述的實施例在所有態樣中僅視為說明性而非限制性。The present invention may be implemented in other forms than those specifically disclosed herein without departing from the spirit or essential characteristics of the invention. The described embodiments are to be considered in all respects only as illustrative and not restrictive.
100:系統 101:殼體 102:殼體 103:埠 104:埠 105:光學導管 106:殼體 107:臂 107a:箭頭 107b:箭頭 108:裝置 109:監視器 109a:箭頭 110:升降器裝置 120:箭頭 121:箭頭 122:箭頭 150:框架 200:系統 201:臂 202:雷射遞送頭 203:成像及定位設備 204:雷射子系統 205:超音波晶體乳化子系統 206:共同殼體 207:共同功率供應器 208:共同控制系統 209:操作者介面 210:緊急停止裝置 211:控制系統及控制器 212:控制系統及控制器 301:xy掃描器 400:光學系統 401:光學系統 402:光學系統 403:光學系統 420:遠側殼體 420a:遠側殼體 420b:遠側殼體 421:臂 421a:連接器 421b:臂 423:近側殼體 423a:雷射頭 423b:近側殼體 430:光學系統 461:瞳孔 462:瞳孔 463:瞳孔 464:瞳孔 500:系統 501:殼體 502:滑動機構 502a:箭頭 503:可移動殼體 504:臂 505:雷射遞送頭 506:位置及形狀決定設備 507:光管路 510:機構 510a:位置調整機構 511:橫向移動組件 512:固定柱 513:自由移動組件 513a:箭頭 520:板 521:板 522:馬達 523:馬達 531:橫向移動組件 610:系統 612:頭枕 613:患者支撐件 620:箭頭 630:角度 630a:角度 631:縱向軸線 632:縱向軸線 641:頭上 642:頭側 650:角 651:角 652:角 653:角 654:角 655:角 656:角 1000:組件 1001a:沙姆相機 1010:自動對接系統 1011:驅動組件 1020:對接環 1040:臂 1200:PID 1201:PID臂 1202:上部窗口 1204:目鏡 1204a:目鏡外裙部 1204b:目鏡內裙部 1205:上部環 1206:下部環 1207a:卡扣 1207b:卡扣 1207c:卡扣 1208a:緩衝器 1208b:緩衝器 1208c:緩衝器 1209:彎月形反向器 1210:儲液環 1211:上部環側壁 1212:鹽水填充通道 1213:真空埠 1220:附接方塊 1221:臂 1221a:臂的鎖定位置 1222:接收夾具 1223:接合球 1224:狹槽（運動狹槽） 1225:用於展示臂移動的箭頭 1226:用於展示方塊接合移動的箭頭 1250:眼睛 1260:雷射超音波裝置 1300:PID 1301:PID臂 1302:上部（遠側）窗口 1303:下部（近側）玻璃窗口 1400:系統 1401:殼體 1402:殼體 1403:底座 1405:光學導管 1406:殼體 1407:臂 1408:雷射束遞送頭 1409:可伸出組件 1410:轉換滑動平台 1411:垂直移動轉換滑動平台 1412:裝置 1413:監視器 1420:水平移動機構 1421:輥 1422:柔性外罩 1423:捲軸 1424:底座 1425:垂直移動機構 1426:水平滑動機構 1427:垂直滑動機構 1428:支撐件 1470:患者介面裝置（PID） 1480:虛線 1490:患者床100: System101: Housing102: Housing103: Port104: Port105: Optical Guide106: Housing107: Arm107a: Arrow107b: Arrow108: Device109: Monitor109a: Arrow110: Elevator120: Arrow121: Arrow122: Arrow150: Frame200: System201: Arm202: Laser Delivery Head203: Imaging and Positioning Device204: Laser Subsystem205: Ultrasonic Phaeemulsification Subsystem206: Common Housing207: Common Power Supply208: Common control system209: Operator interface210: Emergency stop device211: Control system and controller212: Control system and controller301: XY scanner400: Optical system401: Optical system402: Optical system403: Optical system420: Distal housing420a: Distal housing420b: Distal housing421: Arm421a: Connector421b: Arm423: Proximal housing423a: Laser head423b: Proximal housing430: Optical system461: Pupil462: Pupil463: Pupil464: Pupil500: System501: Housing502: Sliding Mechanism502a: Arrow503: Movable Housing504: Arm505: Laser Delivery Head506: Position and Shape Determination Device507: Light Pipe510: Mechanism510a: Position Adjustment Mechanism511: Lateral Movement Assembly512: Fixed Column513: Free Movement Assembly513a: Arrow520: Plate521: Plate522: Motor523: Motor531: Lateral Movement Assembly610: System612: Headrest613: Patient support620: Arrow630: Angle630a: Angle631: Longitudinal axis632: Longitudinal axis641: Superior642: Lateral650: Angle651: Angle652: Angle653: Angle654: Angle655: Angle656: Angle1000: Assembly1001a: Sham Camera1010: Automatic Docking System1011: Drive Assembly1020: Docking Ring1040: Arm1200: PID1201: PID Arm1202: Upper Window1204: Eyepiece1204a: Eyepiece outer skirt1204b: Eyepiece inner skirt1205: Upper ring1206: Lower ring1207a: Snap-on1207b: Snap-on1207c: Snap-on1208a: Buffer1208b: Buffer1208c: Buffer1209: Meniscus deflector1210: Liquid storage ring1211: Upper ring sidewall1212: Salt water filling channel1213: Vacuum port1220: Attachment block1221: Arm1221a: Arm locking position1222: Receiving fixture1223: Joint ball1224: Slot (motion slot)1225: Arrows showing arm movement1226: Arrows showing block joint movement1250: Eye1260: Laser ultrasound device1300: PID1301: PID arm1302: Upper (distal) window1303: Lower (proximal) glass window1400: System1401: Housing1402: Housing1403: Base1405: Optical guide1406: Housing1407: Arm1408: Laser beam delivery head1409: Extendable assembly1410: Translating slide platform1411: Vertical translation slide platform1412: Device1413: Monitor1420: Horizontal translation mechanism1421: Roller1422: Flexible cover1423: Scroll1424: Base1425: Vertical translation mechanism1426: Horizontal slide mechanism1427: Vertical slide mechanism1428: Support1470: Patient interface device (PID)1480: Dashed line1490: Patient bed
第1圖係為根據本發明的雷射超音波系統的實施例的透視圖。FIG1 is a perspective view of an embodiment of a laser ultrasound system according to the present invention.
第2圖係為根據本發明的毫微微超音波乳化系統的實施例的透視圖。FIG2 is a perspective view of an embodiment of a femto-phacoemulsification system according to the present invention.
第3圖係為根據本發明的毫微微超音波乳化系統的實施例的透視圖。FIG3 is a perspective view of an embodiment of a femto-phacoemulsification system according to the present invention.
第4圖係為根據本發明的用於毫微微第二雷射系統的光學系統及光學路徑的實施例以及毫微微超音波乳化系統的實施例的示意圖。FIG. 4 is a schematic diagram of an embodiment of an optical system and an optical path for a femtosecond laser system and an embodiment of a femtophanic emulsification system according to the present invention.
第4A圖係為治療及掃描雷射光學系統的實施例與第4圖的實施例的光學路徑的示意圖。FIG. 4A is a schematic diagram of an embodiment of a treatment and scanning laser optical system and the optical path of the embodiment of FIG. 4 .
第4B圖係為沙姆光學系統的實施例與第4圖的實施例的光學路徑的示意圖。FIG4B is a schematic diagram of an embodiment of a Sham optical system and an optical path of the embodiment of FIG4.
第4C圖係為沿著治療雷射（沿著管路而下）光學系統的光學路徑與第4圖的實施例的光學路徑觀看的IR照相機的實施例的示意圖。FIG. 4C is a schematic diagram of an embodiment of an IR camera viewed along the optical path of the treatment laser (down the tube) optical system and the optical path of the embodiment of FIG. 4 .
第4D圖係為沿著治療雷射（沿著管路而下）光學系統的光學路徑與第4圖的實施例的光學路徑觀看的彩色照相機的實施例的示意圖。FIG4D is a schematic diagram of an embodiment of a color camera viewed along the optical path of the treatment laser (down the tube) optical system and the optical path of the embodiment of FIG4.
第4E圖係為根據本發明的光學系統與路徑的實施例的示意圖。FIG. 4E is a schematic diagram of an embodiment of an optical system and path according to the present invention.
第4F圖係為根據本發明的光學系統與路徑的實施例的示意圖。FIG. 4F is a schematic diagram of an embodiment of an optical system and path according to the present invention.
第4G圖係為根據本發明的光學系統與路徑的實施例的示意圖。Figure 4G is a schematic diagram of an embodiment of an optical system and path according to the present invention.
第5圖係為根據本發明的系統的透視圖。FIG5 is a perspective view of a system according to the present invention.
第5A圖係為根據本發明的系統的實施例的一部分的頂視圖。FIG. 5A is a top view of a portion of an embodiment of a system according to the present invention.
第5B圖係為根據本發明的定位組件的實施例的透視圖。FIG. 5B is a perspective view of an embodiment of a positioning assembly according to the present invention.
第5C圖係為根據本發明的定位組件的實施例的透視圖。FIG. 5C is a perspective view of an embodiment of a positioning assembly according to the present invention.
第5D圖至第5H圖係為根據本發明的本系統的實施例的位置的側視圖。Figures 5D to 5H are side views of the positions of embodiments of the system according to the present invention.
第5I圖係為根據本發明的鉸接式光管路的實施例的透視圖。FIG. 5I is a perspective view of an embodiment of a hinged light pipe according to the present invention.
第6圖係為根據本發明的系統的配置的實施例的頂視圖。Figure 6 is a top view of an embodiment of the configuration of the system according to the present invention.
第7圖係為根據本發明的系統的配置的實施例的頂視圖。Figure 7 is a top view of an embodiment of the configuration of the system according to the present invention.
第8圖係為根據本發明的沙姆組件的實施例的頂視圖。Figure 8 is a top view of an embodiment of a sham assembly according to the present invention.
第9圖係為根據本發明的沙姆組件的實施例的頂視圖。Figure 9 is a top view of an embodiment of a sham assembly according to the present invention.
第10A圖及第10B圖係為根據本發明的近端組件及對接系統的實施例的透視圖。Figures 10A and 10B are perspective views of an embodiment of a proximal assembly and a docking system according to the present invention.
第11圖係為人類眼睛的橫截面圖。Figure 11 is a cross-sectional view of the human eye.
第11A圖係為第11圖的眼睛的水晶體的橫截面圖。FIG. 11A is a cross-sectional view of the lens of the eye in FIG. 11 .
第12A圖係為根據本發明的患者介面裝置（PID）的實施例的透視圖。FIG. 12A is a perspective view of an embodiment of a patient interface device (PID) according to the present invention.
第12B圖係為第12A圖的PID的放大透視圖。FIG. 12B is an enlarged perspective view of the PID of FIG. 12A .
第12C圖係為第12A圖的PID的頂部透視圖。FIG. 12C is a top perspective view of the PID of FIG. 12A .
第12D圖係為第12A圖的PID的橫截面圖。FIG12D is a cross-sectional view of the PID in FIG12A.
第12E圖係為第12A圖的PID的透視圖。FIG. 12E is a perspective view of the PID of FIG. 12A .
第12F圖係為第12A圖的PID的橫截面圖。FIG12F is a cross-sectional view of the PID in FIG12A.
第12G圖係為將第12A圖的PID附接至根據本發明的雷射超音波系統的實施例的方式的透視圖。FIG. 12G is a perspective view of a manner of attaching the PID of FIG. 12A to an embodiment of a laser ultrasound system according to the present invention.
第12H圖係為附接至根據本發明的雷射超音波系統的實施例的第12A圖的PID的透視圖。FIG. 12H is a perspective view of the PID of FIG. 12A attached to an embodiment of a laser ultrasound system according to the present invention.
第12I圖係為用於將PID附接至根據本發明的雷射超音波系統的實施例的鎖定機構的實施例的透視圖。FIG. 12I is a perspective view of an embodiment of a locking mechanism for attaching a PID to an embodiment of a laser ultrasound system according to the present invention.
第12J圖係為從另一側觀察的第12I圖的鎖定機構的透視圖。FIG. 12J is a perspective view of the locking mechanism of FIG. 12I viewed from another side.
第13圖係為根據本發明的PID的實施例的透視圖。FIG13 is a perspective view of an embodiment of a PID according to the present invention.
第14圖係為根據本發明的毫微微超音波乳化系統的實施例的透視圖。FIG. 14 is a perspective view of an embodiment of a femto-phacoemulsification system according to the present invention.
第15圖係為第14圖的毫微微超音波乳化系統的一部分的透明透視圖。FIG. 15 is a transparent perspective view of a portion of the femto-phacoemulsification system of FIG. 14 .
第15A圖係為第14圖的毫微微超音波乳化系統的水平及垂直移動機構的透視圖。FIG15A is a perspective view of the horizontal and vertical movement mechanisms of the femto-emulsification system of FIG14.
第15B圖係為根據本發明的處於伸出位置的第15A圖的機構的透視圖。FIG. 15B is a perspective view of the mechanism of FIG. 15A in an extended position according to the present invention.
第16A圖係為根據本發明的在手術室中且處於完全縮回位置的第14圖的系統的平面圖。FIG. 16A is a plan view of the system of FIG. 14 in an operating room and in a fully retracted position according to the present invention.
第16B圖係為根據本發明的在手術室中且處於部分伸出的雷射操作配置（第一位置）的第14圖的系統的平面圖。Figure 16B is a plan view of the system of Figure 14 in an operating room and in a partially extended laser operating configuration (first position) in accordance with the present invention.
第16C圖係為根據本發明的在手術室中且處於完全伸出的雷射操作配置的第14圖的系統的平面圖。FIG. 16C is a plan view of the system of FIG. 14 in an operating room and in a fully extended laser operating configuration in accordance with the present invention.
第17A圖至第17C圖係為一系列照片，展示第14圖的系統的可伸縮組件在伸出及縮回時的特定位置。第17A圖圖示用於雷射系統的測試及校準的中性伸出位置。第17B圖圖示用於治療雷射操作的第一操作伸出位置。第17C圖圖示用於治療雷射操作的第二操作伸出位置（完全伸出）。Figures 17A through 17C are a series of photographs illustrating the retractable assembly of the system of Figure 14 in specific positions during extension and retraction. Figure 17A illustrates the neutral extended position used for testing and calibration of the laser system. Figure 17B illustrates the first operational extended position for therapeutic laser operation. Figure 17C illustrates the second operational extended position (fully extended) for therapeutic laser operation.
第18圖係為根據本發明的直射光學路徑的實施例的示意圖。FIG18 is a schematic diagram of an embodiment of a direct optical path according to the present invention.
第19圖係為根據本發明的沿著管路而下（DTP）的彩色光學路徑的實施例的示意圖。FIG. 19 is a schematic diagram of an embodiment of a down-the-pipe (DTP) color optical path according to the present invention.
國內寄存資訊(請依寄存機構、日期、號碼順序註記) 無 國外寄存資訊(請依寄存國家、機構、日期、號碼順序註記) 無Domestic Storage Information (Please enter in order by institution, date, and number)NoneInternational Storage Information (Please enter in order by country, institution, date, and number)None
100:系統100:System
101:殼體101: Shell
102:殼體102: Shell
103:埠103: Port
104:埠104: Port
105:光學導管105: Optical guide tube
106:殼體106: Shell
107:臂107: Arm
107a:箭頭107a: Arrow
107b:箭頭107b: Arrow
108:裝置108: Device
109:監視器109: Monitor
109a:箭頭109a: Arrow
110:升降器裝置110: Lifter device
120:箭頭120: Arrow
121:箭頭121: Arrow
122:箭頭122: Arrow
150:框架150:Framework
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| TW112125501ATWI890090B (en) | 2020-12-31 | 2020-12-31 | Methods and systems for combined sonic and laser applications for the eye |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| TW112125501ATWI890090B (en) | 2020-12-31 | 2020-12-31 | Methods and systems for combined sonic and laser applications for the eye |
| Publication Number | Publication Date |
|---|---|
| TW202344232A TW202344232A (en) | 2023-11-16 |
| TWI890090Btrue TWI890090B (en) | 2025-07-11 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TW112125501ATWI890090B (en) | 2020-12-31 | 2020-12-31 | Methods and systems for combined sonic and laser applications for the eye |
| Country | Link |
|---|---|
| TW (1) | TWI890090B (en) |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TW201707662A (en)* | 2015-07-13 | 2017-03-01 | 諾華公司 | Illuminated ophthalmic infusion line and associated devices, systems, and methods |
| US20180168859A1 (en)* | 2011-05-12 | 2018-06-21 | Carl Zeiss Meditec Ag | Laser instrument for eye therapy |
| US20190083304A1 (en)* | 2016-10-21 | 2019-03-21 | Doug Patton | Systems and methods for combined femto-phaco surgery |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20180168859A1 (en)* | 2011-05-12 | 2018-06-21 | Carl Zeiss Meditec Ag | Laser instrument for eye therapy |
| TW201707662A (en)* | 2015-07-13 | 2017-03-01 | 諾華公司 | Illuminated ophthalmic infusion line and associated devices, systems, and methods |
| US20190083304A1 (en)* | 2016-10-21 | 2019-03-21 | Doug Patton | Systems and methods for combined femto-phaco surgery |
| Publication number | Publication date |
|---|---|
| TW202344232A (en) | 2023-11-16 |
| Publication | Publication Date | Title |
|---|---|---|
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