Septum retainer ring for an ophthalmic surgical cassette

Abstract

Embodiments disclosed herein provide a surgical cassette that includes a pump assembly that improves contact between a displacement sensor disposed within a surgical console and a diaphragm disposed within the surgical cassette. Each pump assembly includes a diaphragm retention ring that provides sufficient creepage distance margin and clearance margin, acts as an introduction piece for the displacement sensor, helps prevent misalignment, and provides robustness for the ultrasonic welding process that couples the diaphragm retention ring to the surgical console. The diaphragm retention ring is impregnated with a lubricant to help seat the displacement sensor with the cassette. A cantilevered portion of the diaphragm retention ring increases the creepage distance margin and clearance margin and increases overall part strength in the event of a collision with the displacement sensor and during ultrasonic welding. An insulator is also provided that further increases the creepage distance margin and clearance margin.

Description

Cross-references to related applications

[0001] This application claims the benefit of U.S. Provisional Application Serial No. 63 / 594,682 (filed October 31, 2023), the contents of which are incorporated herein by reference in their entirety. Background Technology

[0002] Ophthalmic surgery is generally classified as anterior segment surgery, posterior segment surgery, or a combination of anterior and posterior segment surgery (i.e., "combination surgery"). The anterior segment refers to the frontmost region of the eye, including the cornea, iris, and lens. Therefore, anterior segment surgery typically includes procedures performed on the iris and / or lens, such as cataract surgery. The posterior segment refers to the backmost region of the eye, including the anterior vitreous membrane and the optical structures behind it, such as the vitreous fluid, retina, choroid, and optic nerve. Posterior segment surgery typically includes retinal surgery and vitreoretinal surgery. In some cases, patients may have eye conditions requiring both anterior and posterior segment surgery; in such cases, combination surgery can be performed.

[0003] During anterior and / or posterior surgical procedures, tissue debris and other materials can be aspirated or extracted from the eye using, for example, a hollow needle or cannula. Furthermore, during surgery, perfusion or infusion fluids can be pumped into the eye to maintain intraocular pressure (IOP) and prevent eye collapse. A surgical cartridge equipped with one or more peristaltic pumps and / or venturi pumps, along with one or more valve assemblies, can be operatively coupled to the fluid control module of a surgical console and used to facilitate the aforementioned aspiration / extraction and perfusion / infusion functions. Typically, one or more valve assemblies of the surgical cartridge are operable to control the application of pressure and vacuum generated by one or more peristaltic pumps during surgical procedures.

[0004] However, conventional surgical cases have many significant drawbacks, including insufficient creepage distance or clearance margin between the displacement sensor mounted on the surgical console and the diaphragm within the surgical case, insufficient introduction of the displacement sensor which may lead to misalignment between the console and the surgical case, and inability to maintain a robust airtight seal with the surgical console.

[0005] Therefore, improved surgical cases are needed to address at least some of the aforementioned drawbacks. For example, the cantilevered portion of the surgical case must be robust enough not only to allow for the correct welding parameters to form an airtight seal with the case, but also to prevent cracking or splitting during the welding process. Summary of the Invention

[0006] This disclosure generally relates to ophthalmic surgical boxes, diaphragms and diaphragm retention ring assemblies for ophthalmic surgical boxes, and methods of using them.

[0007] In some embodiments, a surgical cartridge is provided for performing ophthalmic irrigation or aspiration during surgical procedures. The surgical cartridge includes one or more pump assemblies, wherein each pump assembly includes a diaphragm retention ring and a diaphragm. The diaphragm retention ring is coupled to a base of the surgical cartridge, and the diaphragm is coupled to the base and disposed within a cavity defined within the diaphragm retention ring. The diaphragm retention ring includes a cantilever portion disposed above at least a portion of the top surface of the diaphragm.

[0008] In some embodiments, a method is provided for measuring fluid pressure within a surgical cassette used for ophthalmic perfusion or aspiration during surgical procedures. The method includes: coupling the surgical cassette to a surgical console; positioning a displacement sensor of the surgical console adjacent to a diaphragm of the surgical cassette; providing creepage distance and clearance margins defined by a cantilevered portion of a diaphragm retention ring coupled to the surgical cassette and positioned between the diaphragm and the displacement sensor; and measuring a change in the position of the diaphragm corresponding to a change in fluid pressure within the diaphragm during surgical procedures. In some other embodiments, the displacement sensor may sense eddies within the top surface of the diaphragm to determine its position. In some other embodiments, an optical sensor, a load sensor, or a piezoelectric-based sensor is used instead of the displacement sensor.

[0009] The following description and accompanying drawings illustrate certain illustrative features of one or more embodiments. Attached Figure Description

[0010] The accompanying drawings depict certain aspects of one or more of the disclosed embodiments and should therefore not be construed as limiting the scope of this disclosure.

[0011] Figure 1A An example of an ophthalmic surgical system that can be used to perform ophthalmic surgery on the eye, according to certain embodiments, is illustrated.

[0012] Figure 1B According to certain embodiments Figure 1A An example of a subsystem of the console of an ophthalmic surgical system.

[0013] Figure 2A This is a rear isometric view of an example surgical box that can be operatively coupled to a console of an ophthalmic surgical system according to certain embodiments.

[0014] Figure 2B According to certain embodiments Figure 2A Rear elevation view of the surgical box.

[0015] Figure 3 According to certain embodiments Figure 2A and Figure 2BAn exploded perspective view of the surgical box, illustrating the components including each pump assembly disposed within the surgical box.

[0016] Figure 4 It is a setting according to certain embodiments Figure 3 A top view of the diaphragm retaining ring within the pump assembly of the surgical box.

[0017] Figure 5A According to certain embodiments Figure 4 A side view cross-sectional view of the diaphragm retaining ring.

[0018] Figure 5B According to certain embodiments Figure 5A A side cross-sectional view of an alternative configuration of the diaphragm retaining ring.

[0019] Figure 5C According to certain embodiments Figure 5A A side cross-sectional view of an alternative configuration of the diaphragm retaining ring.

[0020] Figure 5D According to certain embodiments Figure 5A A side cross-sectional view of an alternative configuration of the diaphragm retaining ring.

[0021] Figure 6 It is a setting according to certain embodiments Figure 3 A three-dimensional view of the diaphragm inside the pump assembly of the surgical box.

[0022] Figure 7A This is a side cross-sectional view of the displacement sensor of the console of an ophthalmic surgical system according to certain embodiments, coupled to the pump assembly of the surgical box.

[0023] Figure 7B According to certain embodiments Figure 7A The diagram shows an enlarged cross-sectional view of the connection between the displacement sensor of the control console and the pump assembly of the surgical box in the ophthalmic surgical system, as well as the creepage curve.

[0024] Figure 7C According to certain embodiments Figure 7A The diagram shows an enlarged cross-sectional view of the connection and gap curve between the displacement sensor of the control console and the pump assembly of the surgical box in the ophthalmic surgical system shown.

[0025] Figure 8 This is a perspective view of a diaphragm with an insulator disposed on its top surface according to certain embodiments.

[0026] Figure 9A The displacement sensor of the console of an ophthalmic surgical system according to certain embodiments includes... Figure 8 Enlarged cross-sectional view of the connection between the pump assembly and the insulator of the surgical box, and the creepage curve.

[0027] Figure 9B The displacement sensor of the console of an ophthalmic surgical system according to certain embodiments includes... Figure 8 Enlarged cross-sectional view of the joint and gap curve between the pump assembly and the insulator of the surgical box.

[0028] To aid understanding, the same reference numerals are used where possible to refer to common elements in the figures. It is contemplated that elements and features of one embodiment can be advantageously combined in other embodiments without further description. Detailed Implementation

[0029] This disclosure generally relates to ophthalmic surgical boxes, diaphragms and diaphragm retention rings used in ophthalmic surgical boxes, and their usage methods.

[0030] Certain embodiments disclosed herein provide diaphragm assemblies for surgical cassettes that improve sensing between a displacement sensor disposed within a surgical console and a diaphragm disposed within the surgical cassette. For example, embodiments herein disclose diaphragm assemblies configured to seal a pressure-sensitive diaphragm within the surgical cassette via an hermetically sealed seal, while also interacting with a displacement sensor on the surgical console. A diaphragm retaining ring provides sufficient creepage distance and clearance margins, serving as an inlet for the displacement sensor, helping to prevent misalignment, and providing robustness for the ultrasonic welding process of attaching the diaphragm retaining ring to the surgical console. In this document, creepage distance and clearance margins refer to the distance that stray or abnormal current must travel between two conductors. Specifically, creepage distance refers to the distance that current must travel along the surface of an insulating material to reach another conductor, while clearance refers to the distance that current must travel through air to reach another conductor.

[0031] In some embodiments, the cantilever portion of the diaphragm retaining ring increases creepage distance and clearance margins. The cantilever portion contributes to overall part strength in the event of a collision with a displacement sensor and during ultrasonic welding. Specifically, the cantilever portion is configured to route the creepage curve in a manner that avoids contact with any additional surfaces of the diaphragm retaining ring, thereby ultimately limiting tolerances affecting the final creepage distance and margin and / or clearance distance and margin. The cantilever portion also features a chamfer, which serves as an introduction for the displacement sensor mounted on the surgical console in the event of a collision. Finally, the chamfered area is formed in a way that limits stress concentration during the ultrasonic welding process, thereby limiting the possibility of cracking or deformation of the inner diameter of the diaphragm retaining ring.

[0032] Some embodiments disclosed herein provide that the diaphragm retaining ring is molded from a material that provides rigidity, hardness, and low friction, and may include a molded-in lubricant to aid in sensor engagement and accuracy.

[0033] Figure 1A An example of an ophthalmic surgical system 10, according to certain embodiments, which can be used to perform ophthalmic surgery on the eye, is illustrated. In the illustrated embodiment, system 10 includes components connected and referenced as shown. Figure 1B The console 100 (also referred to as the "surgical console"), housing 102, display screen 104, interface device 107 (e.g., foot pedal), fluid control subsystem 110, and handheld device 112 are described in more detail.

[0034] Figure 1B According to certain embodiments Figure 1A Examples of subsystems of the console 100 of the ophthalmic surgical system 10. The console 100 includes a housing 102 that houses a computer 103 (with an associated display screen 104) and subsystems 106, 110, and 116 supporting an interface device 107 and handheld devices 112 (112a-c). The interface device 107 receives input to the surgical system 10, sends output from the system 10, and / or processes input and / or output. Examples of the interface device 107 include a foot pedal, a manual input device (e.g., a keyboard), and a display. The interface subsystem 106 receives input from the interface device 107 and / or sends output to the interface device.

[0035] Handpiece 112 can be any suitable ophthalmic surgical instrument, such as an ultrasound-driven phacoemulsification (phaco) handpiece, a laser handpiece, an irrigation cannula, a vitrectomy handpiece, or another suitable surgical handpiece. Fluid control subsystem 110 provides fluid control for one or more handpieces 112 (112a-c). For example, fluid control subsystem 110 can manage the fluid used for irrigation cannula. Handpiece subsystem 116 supports one or more handpieces 112. For example, handpiece subsystem 116 can manage the ultrasound oscillations of the phaco handpiece, provide laser energy to the laser handpiece, control the operation of the irrigation cannula, and / or manage the features of the vitrectomy handpiece.

[0036] Computer 103 controls the operation of ophthalmic surgical system 10. In some embodiments, computer 103 includes a controller that sends instructions to components of system 10 to control system 10. Display screen 104 displays data provided by computer 103.

[0037] Figure 2A It is a console that can be operatively connected to an ophthalmic surgical system according to certain embodiments (e.g., Figures 1A to 1B The illustration shows a rear isometric view of an example surgical box 200 of the control console 100 of the ophthalmic surgical system 10. Figure 2B According to certain embodiments Figure 2AThe rear elevation view of the surgical box 200. For clarity, this article will... Figures 2A to 2B Described together. The surgical cartridge 200 includes two pump assemblies 202 (202a-b) providing a pressure source and / or a vacuum source, and four valve assemblies 204 (204a-d) controlling pressure and / or fluid communication within the surgical cartridge 200. In some other embodiments, there may be only one pump assembly or more than two pump assemblies. In some other embodiments, there may be more or fewer than four valve assemblies (e.g., two to six valve assemblies).

[0038] In some embodiments, the surgical cartridge 200 is coupled to an external pressure source and / or vacuum source. In such embodiments, the external source may serve as an alternative to or supplement to the pump assembly 202.

[0039] The surgical cartridge 200 has a housing 205, which includes a base 206, a cover assembly 208 coupled to the base 206, and inlet / outlet ports 210 (210a, 210b, 210c) in the base 206, which provide pressure and / or fluid communication between the interior and exterior of the housing 205. Each port 210a-c corresponds to a component of the fluid control subsystem 110 and / or a corresponding handheld component 112a-c. Figures 1A to 1B Fluid lines (e.g., fittings) can be connected between them.

[0040] In some embodiments, one of the first pump assembly 202a or the second pump assembly 202b provides a pressure source (e.g., to generate a driving force for fluid infusion), while the other of the first pump assembly 202a or the second pump assembly 202b provides a vacuum source (e.g., to generate a suction force for fluid aspiration). The first pump assembly 202a and the second pump assembly 202b may be peristaltic pumps or any other suitable type of pump for generating pressure and / or vacuum. In some embodiments, the first pump assembly 202a and the second pump assembly 202b are identical to each other.

[0041] Valve assembly 204 is coupled to base 206. Valve assembly 204 cooperatively functions to control pressure and / or fluid communication within and through surgical cartridge 200. In the illustrated embodiment, surgical cartridge 200 includes a first valve assembly 204a, a second valve assembly 204b, a third valve assembly 204c, and a fourth valve assembly 204d. As shown, in Figure 2A In one embodiment, four valve assemblies 204 are arranged at the four corners of the base 206, thereby surrounding the two pump assemblies 202 arranged toward the center of the base 206. However, in some other embodiments, the pump assemblies 202 and valve assemblies 204 may have any other suitable arrangement.

[0042] As in Figure 3As seen in the exploded view, each pump assembly 202a, 202b is respectively coupled to and disposed within a first well 308a and a second well 308b defined within a base 206. Each well 308a, 308b includes an inlet 310 and an outlet 312 defined therein, which are in fluid communication with an internal channel disposed within the surgical cassette 200. Each pump assembly 202a, 202b includes a pump elastomer 302 disposed around the outer circumference of each well 308a, 308b. In some embodiments, each of the first pump assembly 202a and the second pump assembly 202b is configured to engage one or more rollers of a roller pump disposed on a surgical console (e.g., console 100). For example, when the surgical cartridge 200 is coupled to the console 100, one or more rollers of the roller pump on the console 100 can contact the pump elastomer 302 of each pump assembly 202a, 202b. Subsequently, during use, the manual force provided by the rollers (as driven by the pump) rolling along and pressing against the pump elastomer 302 can drive the fluid within the corresponding pump assembly 202a or 202b, thereby driving the fluid within the surgical cartridge 200 to generate pressure or vacuum as needed. A diaphragm 306 is disposed in the central portion of each cavity 308a, 308b in a substantially nested or stacked configuration, the diaphragm being accommodated or positioned below the diaphragm retention ring 304. In some embodiments, the diaphragm retaining ring 304 is joined to the inner surface of the cavities 308a, 308 by an ultrasonic welding process, wherein the diaphragm 306 is disposed below, thereby holding the diaphragm 306 within each respective cavity 308a, 308b and providing an airtight seal with the base 206.

[0043] exist Figure 4 and Figures 5A to 5D More detailed information about the diaphragm retention ring 304 is shown in both top plan and cross-sectional views. The diaphragm retention ring 304 includes an annular or ring-shaped top surface (or upper surface) 314 defined between an outer circumference 316 and an inner circumference 318. The top surface 314 is circumferentially surrounded by a raised lip or edge 320. An orifice 322 is defined at the center of the diaphragm retention ring 304 and within the inner circumference 318, which allows a displacement sensor disposed in the surgical console 100 to directly access the surface of the diaphragm 306 disposed below the diaphragm retention ring 304, such as... Figure 7A and Figure 7BAs detailed above. Furthermore, a plurality of positioning features 326 (326a, 326b, 326c) are defined in the top surface 314. The plurality of positioning features 326 are symmetrically defined within the top surface 314. In some embodiments, each of the positioning features 326 includes a different footprint, shape, cross-sectional depth, profile, or coefficient of friction. For example, the first positioning feature 326a includes an angled or V-groove cross-sectional profile, while the second positioning feature 326b includes a generally flat cross-sectional profile, and the third positioning feature 326c includes a conical cross-sectional profile. In some embodiments, the raised lip or edge 320 also functions as an introduction or positioning feature of the pressure sensor 400 in the same manner described below for the positioning features 326. Figure 4 Also seen is a notch 317 defined within the outer circumference 316 of the diaphragm retaining ring 304, which can facilitate rotational alignment of the diaphragm retaining ring 304 relative to the base 206 during manufacturing. In some embodiments, the notch 317 includes a generally semi-circular or crescent-shaped shape; however, other shapes may be used in other embodiments.

[0044] In some embodiments, the diaphragm retention ring 304 is formed of a thermoplastic polymer material that is sufficiently elastic to withstand impact forces in the event of a collision with the displacement sensor or any other part of the surgical console 100, and is also suitable for engaging with the diaphragm 306 and providing an hermetically tight seal when the diaphragm retention ring 304 is coupled to the base 206. For example, the diaphragm retention ring 304 may be formed of a sufficiently robust material to prevent or reduce damage or cracking to the inner diameter of the diaphragm retention ring 304, which would reduce creepage distance and / or clearance distance. In other embodiments, the diaphragm retention ring 304 is formed of a suitable material other than a thermoplastic polymer material.

[0045] In some embodiments, the diaphragm retention ring 304 is made of or impregnated with an "embedded" lubricant to provide a desired coefficient of friction on the top surface 314 and within the positioning features 326a-c. This facilitates the positioning of the displacement sensor when attaching the surgical cartridge 200 to the surgical console 100, as the displacement sensor of the surgical console 100 can be more easily moved to its final position above the diaphragm 306 on the top surface 314 of the diaphragm retention ring 304 and within the positioning features 326a-c. In some embodiments, the diaphragm retention ring 304 contains up to 10% lubricant by weight. In some embodiments, the diaphragm retention ring 304 contains up to 10% or more lubricant by weight. In some embodiments, the lubricant is ultra-high molecular weight silicone or siloxane; however, other lubricants may be used instead of or in addition to those disclosed herein. Using "embedded" lubricant offers several advantages, including a cleaner manufacturing process, reduced likelihood of lubricant contact with the end user or patient, prevention of unintentional particulate matter adhering to the surfaces of the diaphragm retaining ring 304 and / or other cartridge components, and ensuring that the lubricant is always in its intended position and in the appropriate amount. In some other embodiments, in addition to or instead of the diaphragm retaining ring 304 itself containing lubricating material, the lubricant can be applied directly to the top surface 314 and within the positioning features 326a-c.

[0046] like Figure 5A As shown, the inner circumference 318 defining the orifice 322 includes a convex or rounded surface or edge 324. The rounded surface 324 begins at the top surface 314 and curves downward until it terminates at the bottom surface 328, which is substantially parallel to the top surface 314. The length of the bottom surface 328 is defined between the end of the rounded surface 324 and the annular or ring-shaped sidewall 330, which forms the outer boundary of the cavity 332 for receiving the diaphragm 306, as further detailed below. Figure 5A The image also shows an alignment feature 331 protruding outward from the sidewall 330 of the diaphragm retention ring 304. The alignment feature 331 corresponds to a matching or corresponding shape feature within the cavities 308a and 308b, such that when the diaphragm retention ring 304 is connected to the surgical box 200, the diaphragm retention ring 304 is correctly aligned with respect to the cavities 308a and 308b. Figure 5AFurther illustration shows how the top surface 314, the rounded surface 324, and the bottom surface 328 defined by the cavity 332 form the corresponding top, side, and bottom of the annular cantilever portion 334 of the diaphragm retention ring 304. Starting from the sidewall 330, the cantilever portion 334 extends radially toward the center of the orifice 322 to provide an overhang or extension of the diaphragm retention ring 304 that covers a corresponding proportion of the top surface 340 of the diaphragm 306. The top surface 314, the rounded surface 324, and the bottom surface 328 provide the cantilever portion 334 with a configuration and cross-sectional thickness that limit stress concentration in the cantilever portion, which in turn reduces cracking and / or deformation of the cantilever portion 334 during the manufacturing process when the diaphragm retention ring 304 is ultrasonically welded to the surgical case 200. According to some embodiments, the cantilever portion 334 further functions as an introduction or positioning feature of the pressure sensor 400 in the same manner described below for positioning feature 326.

[0047] Figures 5B to 5D Depicting Figure 5A Several different embodiments of the diaphragm retaining ring 304 are shown. Figure 5B An alternative diaphragm retention ring 504 is shown, comprising a cantilever portion 534 defined by a top surface 514 extending radially inward from a sidewall 520. The top surface 514 terminates in a generally semi-circular shape or rounded edge 524. The bottom of the cantilever portion 534 is defined by a first bottom surface 526 substantially parallel to the top surface 514. The first bottom surface 526 leads to an angled surface 528, which in turn leads to a second bottom surface 530. In some embodiments, both the angled surface 528 and the second bottom surface 530 are angled relative to the top surface 514. According to some embodiments, the angled surface 528 is positioned at a larger angle relative to the top surface 514 than the second bottom surface 530. According to some embodiments, the cantilever portion 534 further functions as an inlet or positioning feature of the pressure sensor 400 in the same manner described below for positioning feature 326.

[0048] Figure 5C An alternative diaphragm retention ring 604 is shown, comprising a cantilever portion 634 defined by a top surface 614 extending radially inward from a sidewall 620. The top surface 614 terminates at a generally curved or rounded edge 624. The bottom of the cantilever portion 634 is defined by a bottom surface 626 extending from the rounded edge 624 to the sidewall 620, the bottom surface 626 comprising a generally convex shape. According to some embodiments, the cantilever portion 634 further functions as an inlet or positioning feature of the pressure sensor 400 in the same manner described below with respect to positioning feature 326.

[0049] Figure 5DAn alternative diaphragm retention ring 704 is shown, comprising a cantilever portion 734 defined by a top surface 714 extending radially inward from a sidewall 720. The top surface 714 terminates at an angled surface 716 leading to a generally curved or rounded edge 724, the angled surface 716 having a flat or planar configuration. The bottom of the cantilever portion 734 is defined by a bottom surface 726 substantially parallel to the top surface 714, the bottom surface 726 connecting or linking the rounded edge 724 and the sidewall 720. According to some embodiments, the cantilever portion 734 further functions as an introduction or positioning feature of the pressure sensor 400 in the same manner described below with respect to positioning feature 326.

[0050] exist Figure 6 The perspective view shows more detailed features of the diaphragm 306. In some embodiments, the diaphragm 306 includes a flat or horizontal top surface 340 of generally circular shape. Sidewalls 342 surrounding the circumference of the top surface 340 connect the top surface 340 to an annular foot 344 disposed around the circumference of the sidewalls 342. In some embodiments, the foot 344 is parallel to the top surface 340. In some embodiments, the sidewalls 342 have curvature, such as sinusoidal curvature, to provide a rounded surface between the top surface 340 and the foot 344. The diaphragm 306 further includes a hollow interior such that when it is coupled to the bottom surface of the corresponding cavities 308a, 308b, fluid entering the cavities 308a, 308b fills the interior portion of the diaphragm 306 up to the underside of the top surface 340. When fluid applies pressure to the underside of the top surface 340, the top surface 340 of the diaphragm 306 flexes accordingly, which is detected and measured by a displacement sensor located in the surgical console 100, which is described in further detail below.

[0051] Figure 7A and Figure 7B It is a top cross-sectional view illustrating the engagement between the housing 200 and the surgical console 100, specifically within the fluid control subsystem 110 of the surgical console 100, and between the displacement sensor 400 and each pump assembly 202a, 202b coupled to the base 206.

[0052] When the cartridge 200 is coupled to the surgical console 100, the diaphragm retention ring 304 serves as an introduction for the displacement sensor 400 in the absence of alignment. According to some embodiments, the displacement sensor 400 includes a plurality of introduction structures 404 (404a-c) corresponding to a plurality of positioning features 326 defined in the top surface 314 of the diaphragm retention ring 304. In some embodiments, the introduction structures 404a, 404b, and 404c disposed on the proximal end of the displacement sensor 400 share the same geometry and dimensions. However, in some other embodiments, each of the introduction structures 404 disposed on the proximal end of the displacement sensor 400 includes a shape, profile, or cross-section corresponding to or matching one of the positioning features 326 to provide a substantially nested or mating engagement therebetween. It should be noted that in the embodiments illustrated above, a second and a third introduction structure 404 may be present on the displacement sensor 400, configured to correspond to and engage with the first positioning feature 326a and the second positioning feature 326b. Additionally, in cases of severe misalignment, the introduction structure 404 of the displacement sensor 400 may fail to engage with the positioning feature 326 of the retaining ring. In this situation, the cantilever portion of the retaining ring will absorb some of the impact from the displacement sensor 400 and can guide the displacement sensor into the retaining ring orifice 322.

[0053] In some embodiments, when the displacement sensor 400 is adjacent to the diaphragm retaining ring 304, contact is made between the introduction structure 404 and the positioning feature 326 of the diaphragm retaining ring 304. As the placement of the housing 200 is adjusted, the introduction structure 404 slides across or down the positioning feature 326 until it is correctly positioned in the corresponding positioning feature 326. In some embodiments, a lubricant, which is part of the material comprising the diaphragm retaining ring 304, or has been applied directly to the top surface 314 and the positioning feature 326, facilitates the sliding of the introduction structure 404 into the positioning feature 326. The displacement sensor 400 is correctly positioned and aligned only when each of the introduction structures 404 has been inserted into or positioned on its corresponding mating positioning feature 326. Once correctly positioned, the sensor surface 402 of the displacement sensor 400 simultaneously inserts through the orifice 322 of the diaphragm retaining ring 304 and is positioned adjacent to the top surface 340 of the diaphragm 306.

[0054] exist Figure 7BMore detailed information about the interaction between the cantilever portion 334, the displacement sensor 400, and the diaphragm 306, according to certain embodiments, can be seen in the diagram. In addition to providing structural support for the displacement sensor 400, the cantilever portion 334 of the diaphragm retaining ring 304 also provides sufficient creepage distance and clearance margin between the displacement sensor 400 and the diaphragm 306. Creepage distance and clearance margin refer to the distance that stray or abnormal current must travel between two conductors. Specifically, creepage distance refers to the distance that current must travel along the surface of an insulating material to reach another conductor, such as... Figure 7B As seen in the diagram, the gap refers to the distance that an electric current must travel through the air to reach another conductor, such as... Figure 7C As seen in the diagram. For example, in some embodiments, the current originating from the displacement sensor 400 must travel along a creepage curve, as shown by line 410, to reach the conductive diaphragm 306, which is defined by the size, shape, and relative placement of the cantilever portion 334 of the diaphragm retaining ring 304. For example, as... Figure 7B As seen, due to the specific thickness and length of the cantilever portion 334, abnormal currents following the creepage curve 410 must first travel down the top surface 314, across and along the rounded surface 324, then through the air gap between the bottom surface 328 and the top surface 340 of the diaphragm 306, and finally contact the diaphragm 306 itself. Therefore, it can be understood that, according to certain embodiments, variations in the thickness of the cantilever portion 334, the overhang length of the cantilever portion 334 relative to the diameter of the diaphragm 306, and the height of the cantilever portion 334 relative to the diaphragm 306 will correspondingly increase or decrease the length of the creepage curve 410.

[0055] Similarly, in some embodiments, the current originating from the displacement sensor 400 must travel along a gap curve, as shown by line 411, to reach the conductive diaphragm 306, which is defined by the size, shape, and relative placement of the cantilever portion 334 of the diaphragm retaining ring 304. For example, as Figure 7C As seen, due to the specific thickness and length of the cantilever portion 334, the abnormal current following the gap curve 411 must first cross and travel downward along the rounded surface 324 after passing through the air gap defined between the top surface 314 and the bottom portion of the displacement sensor, then travel through the air gap between the bottom surface 328 and the top surface 340 of the diaphragm 306, and then contact the diaphragm 306 itself. Therefore, it can be understood that, according to certain embodiments, variations in the thickness of the cantilever portion 334, the overhang length of the cantilever portion 334 relative to the diameter of the diaphragm 306, and the height of the cantilever portion 334 relative to the height of the diaphragm 306 will correspondingly increase or decrease the length of the gap curve 411.

[0056] In some embodiments, the displacement sensor 400 is an eddy current sensor configured to detect changes in the position of the top surface 340 of the diaphragm 306. After being properly positioned within the diaphragm retaining ring 304, the sensor surface 402 of the displacement sensor 400 is positioned adjacent to the top surface 340 of the diaphragm 306. During ophthalmic surgery, fluid is pumped or aspirated through the cartridge 200 and enters at certain points each corresponding cavity 308a, 308b beneath the internal volume of the corresponding diaphragm 306. As more fluid enters the internal volume, the pressure within the diaphragm 306 increases, causing the top surface 340 to deform to form at least a partially rounded or convex surface. In other embodiments, the internal pressure decreases as fluid leaves the internal volume of the diaphragm 306 or is evacuated from it, which can smooth or flatten the top surface 340 of the diaphragm, or in other embodiments, form a recessed or concave surface if fluid continues to flow out of the diaphragm 306. In either instance, the position of the top surface 340 of the diaphragm 306 changes accordingly. The eddy current sensor includes a coil energized by high-frequency alternating current located behind surface 402. The change in diaphragm position causes a change in the impedance of the sensor coil. Detecting this change in impedance, which in turn sends a signal indicating displacement, and therefore indicating a pressure measurement, to a computer 103 within the surgical console 100. The console can use this pressure to adjust performance or to inform the user of the current fluid pressure within each pump assembly 202a, 202b.

[0057] In some embodiments, an insulator 350 is attached to or disposed on the top surface 340 of the diaphragm 306, such as... Figure 8 As seen in Figure 9, the insulator 350 includes an upward-facing surface 352 and, in some embodiments, is shaped to match the corresponding shape of the top surface 340 of the diaphragm 306. For example, as... Figure 8 As seen, the insulator 350 includes a generally circular surface area to completely cover the circular top surface 340 of the diaphragm 306. In some other embodiments, the diameter of the insulator 350 is smaller than the diameter of the diaphragm 306, thereby leaving at least a portion of the top surface 340 of the diaphragm 306 uncovered. In other embodiments, the insulator 350 includes an annular or ring-shaped form that exposes the inner portion or radius of the top surface 340 of the diaphragm 306. The insulator 350 is attached to the diaphragm by an adhesive; however, in some other embodiments, other attachment means are used, such as coating or overmolding. In some embodiments, the insulator 350 comprises a layer or thickness of electrically insulating material, including but not limited to polymers and thermoplastics, such as polyester films or polypropylene sheets. However, in other embodiments, additional materials that are insulating to current but do not affect the induction or measurement of eddy currents, such as ceramics or glass, may be used.

[0058] Figure 9A and Figure 9BThe illustration shows how an insulator 350 is incorporated into pump assemblies 202a, 202b according to certain embodiments. The insulator 350 is coupled to the top surface 340 of the diaphragm 306, wherein the upward-facing surface 352 is disposed below the bottom surface 328 of the cantilever portion 334 and the sensor surface 402. The insulator 350 is incorporated with the cantilever portion 334 of the diaphragm retaining ring 304 to provide or enhance... Figure 9A As shown in thick line 412, the creepage curve is provided or enhanced. Figure 9B The gap curve is shown as thick line 413. In some embodiments, an abnormal current originating from displacement sensor 400 must first travel along a creepage curve 412 or gap curve 413 defined by the size, shape, and relative placement of the cantilever portion 334 of diaphragm retaining ring 304, and then travel over at least a portion of the radial length of insulator 350 to reach conductive diaphragm 306. For example, as shown... Figure 9A As seen, due to the specific thickness and length of the cantilever portion 334, the current following the creepage curve 412 must travel along the top surface 314, cross and travel downwards along the rounded surface 324, and then travel through the air gap between the bottom surface 328 of the cantilever portion 334 and the upward-facing surface 352 of the insulator 350. The current must then travel across the width of the upward-facing surface 352, then across the height of the insulator 350, and then contact the diaphragm 306 itself. Therefore, it can be understood that, according to certain embodiments, variations in the thickness of the cantilever portion 334, the overhang length of the cantilever portion 334 relative to the diameter of the diaphragm 306, the height of the cantilever portion 334 relative to the height of the diaphragm 306, and the length and height of the insulator 350, consequently increase or decrease the length of the creepage curve 412.

[0059] Similarly, for example, such as Figure 9B As seen, due to the specific thickness and length of the cantilever portion 334, the current following the gap curve 413 must cross the air gap defined between the top surface 314 and the bottom portion of the displacement sensor, travel downwards along the rounded surface 324, and then cross the air gap between the bottom surface 328 of the cantilever portion 334 and the upward-facing surface 352 of the insulator 350. The current must then travel across the width of the upward-facing surface 352, then across the height of the insulator 350, and then contact the diaphragm 306 itself. Therefore, it can be understood that, according to certain embodiments, variations in the thickness of the cantilever portion 334, the overhang length of the cantilever portion 334 relative to the diameter of the diaphragm 306, the height of the cantilever portion 334 relative to the height of the diaphragm 306, and the length and height of the insulator 350, consequently increase or decrease the length of the gap curve 413.

[0060] In some embodiments, the insulator 350 is coupled to the bottom surface 328 of the cantilever portion 334, to the top surface 314 of the diaphragm retaining ring 304, or to any height raised or positioned at a distance relative to the top surface 340 of the diaphragm 306. In other embodiments, the insulator 350 fills a portion of the height or space defined between the top surface 340 of the diaphragm 306 and the bottom surface 328 of the cantilever portion 334. In some other embodiments, the structure of the insulator 350 is integrated with or incorporated into the structure of the cantilever portion 334 of the diaphragm retaining ring 304 itself.

[0061] Therefore, this article provides a device for providing sufficient creepage distance margin or clearance margin between a displacement sensor mounted on a surgical console and a diaphragm mounted inside a surgical box, a device for providing sufficient inlet for the displacement sensor, and a method for using the same.

[0062] The foregoing description is provided to enable any person skilled in the art to practice the various embodiments described herein. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein can be applied to other embodiments. Therefore, the claims are not intended to limit them to the embodiments shown herein, but are given the full scope consistent with the language of the claims.

Claims

1. A surgical box for ophthalmic surgery, the surgical box comprising: At least one pump assembly, wherein the at least one pump assembly comprises: A diaphragm retention ring, the diaphragm retention ring being connected to the base of the surgical box; and A diaphragm, the diaphragm being coupled to the base and disposed within a cavity defined within the diaphragm retaining ring, The diaphragm retaining ring includes a cantilever portion, which is disposed above at least a portion of the top surface of the diaphragm.

2. The surgical box as described in claim 1, wherein, The diaphragm retaining ring includes: The top surface of the diaphragm ring; Sidewalls extending downward from the top surface of the diaphragm ring; and An orifice, the orifice being defined at the center of the top surface of the diaphragm ring, The cantilever portion is integral with the sidewall.

3. The surgical box as described in claim 2, wherein, The top surface of the diaphragm ring, the orifice, and the cavity each define the upper surface, rounded surface, and bottom surface of the cantilever portion of the diaphragm retaining ring, respectively.

4. The surgical box as described in claim 3, wherein, The bottom surface is at least substantially parallel to the top surface of the diaphragm ring.

5. The surgical box as described in claim 3, wherein, The bottom surface includes a first bottom surface and a second bottom surface connected by angled surfaces, the angled surfaces and the second bottom surface being arranged at an angle relative to the top surface of the diaphragm ring.

6. The surgical box as described in claim 3, wherein, The bottom surface has a convex shape.

7. The surgical box as described in claim 3, wherein, The diaphragm retaining ring provides a creepage curve and a gap curve, which are defined by the upper surface of the cantilever portion, the rounded surface of the cantilever portion, and the gap defined between the bottom surface of the cantilever portion and the diaphragm.

8. The surgical box as claimed in claim 2, wherein, The cantilever portion extends radially toward the center of the orifice.

9. The surgical box of claim 2, wherein the surgical box further comprises a plurality of positioning features symmetrically defined within the top surface of the diaphragm ring.

10. The surgical box as claimed in claim 9, wherein, Each of the plurality of positioning features is configured to correspond to one of a plurality of introduction structures disposed on the displacement sensor of the surgical console.

11. The surgical box as claimed in claim 9, wherein, The plurality of positioning features include at least one of a V-shaped groove cross-sectional profile, a flat cross-sectional profile, or a conical cross-sectional profile.

12. The surgical box as claimed in claim 1, wherein, The diaphragm retaining ring includes at least one lubricant.

13. The surgical box as claimed in claim 12, wherein, The diaphragm retaining ring contains up to 10% by weight of the at least one lubricant.

14. The surgical case of claim 1, further comprising an insulator disposed between the diaphragm and the surface of the displacement sensor when the surgical case is connected to a surgical control console.

15. The surgical box as claimed in claim 14, wherein, The insulator is attached to the top surface of the diaphragm.

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