Pump elastomeric sealing reinforcement for surgical cartridges

Abstract

Some embodiments provide a surgical cassette designed for use during an ophthalmic procedure, the surgical cassette having a multi-chamber pump elastomer to seal a plurality of chambers within a device. The elastic body is composed of a silicone rubber member having a plurality of grooves coupled to a top surface thereof and a sealing bead coupled to a lower portion thereof. The grooves enable lateral deformation of the silicone rubber under compression, thereby improving sealing of the plurality of chambers and reducing or eliminating leakage paths, thereby enhancing performance of the device. A sealing bead strategically placed on the lower portion of the silicone rubber component prevents the pump elastomer from separating and lifting at the corner by conforming to the geometry of the corner.

Description

Pump elastomer seal reinforcement for surgical cases Cross-references to related applications

[0001] This application claims the benefit of U.S. Provisional Application Serial No. 63 / 594,910 (filed October 31, 2023), the contents of which are incorporated herein by reference in their entirety. Background Technology

[0002] Cataract surgery involves removing the cataracted lens and replacing it with an artificial lens (IOL). Cataract lens removal is typically achieved by fracturing the lens and aspirating the fragments outside the eye. The lens can be fractured using instruments such as phacoemulsification probes, laser probes, or other suitable instruments. During the procedure, the probe fractures the lens, and the fragments are aspirated outside the eye using, for example, a hollow needle or cannula. Throughout the procedure, irrigation fluid is pumped into the eye to maintain intraocular pressure (IOP) and prevent eye collapse.

[0003] During cataract surgery, a surgical cartridge containing one or more peristaltic pumps and / or venturi pumps, as well as one or more valve assemblies, can be operatively coupled to the fluid control module of the surgical console and used to facilitate the aforementioned aspiration and perfusion functions. Typically, one or more valve assemblies of the surgical cartridge are operable to control the application of pressure and vacuum generated by the one or more peristaltic pumps during the procedure.

[0004] However, conventional surgical boxes have many significant drawbacks, including relatively tight sealing tolerances, relatively high torque required for valve operation, limited flow capacity, inability to maintain a secure connection with the surgical console, relatively high manufacturing costs and complexity, and redundancy issues. Summary of the Invention

[0005] One or more embodiments of this document include a surgical cartridge comprising a multi-chamber pump elastomer assembly designed to seal multiple chambers within the cartridge. In some embodiments, the surgical cartridge is designed for use during ophthalmic surgery. The surgical cartridge has one or more chambers for storing fluid, and a pump elastomer that effectively seals these chambers when fully compressed. In some embodiments, the surgical cartridge includes one or more recesses positioned on the pump elastomer. The recesses facilitate lateral deformation (or lateral displacement) of a portion of the pump elastomer when it is compressed and engaged with a base. The presence of the recesses helps to reduce or eliminate potential leakage paths of fluid at the interface between the pump elastomer and the base, thereby ensuring safer and more efficient performance during ophthalmic surgery.

[0006] Some embodiments include a surgical cartridge having a multi-chamber pump elastomer for sealing multiple chambers via seal beads. In some embodiments, the surgical cartridge includes multiple seal beads strategically positioned on the base of the pump elastomer. When the pump elastomer is compressed, these seal beads fill potential leakage paths of fluid at the interface between the pump elastomer and the base. By filling these leakage paths, the seal beads eliminate or reduce internal leakage between the chambers of the multi-chamber pump elastomer, ultimately enhancing the performance of the surgical cartridge during ophthalmic surgery. Attached Figure Description

[0007] To gain a detailed understanding of the features described above, reference can be made to the embodiments to provide a more specific description of the briefly summarized disclosure, some of which are illustrated in the accompanying drawings. However, it should be noted that the drawings only illustrate some aspects of the disclosure, and that the disclosure may allow for other equally effective embodiments.

[0008] Figure 1 shows a schematic diagram of an exemplary ophthalmic surgical system according to some embodiments.

[0009] Figure 2A is a rear isometric view of an example surgical box that can be operatively coupled to the ophthalmic surgical system of Figure 1 according to some embodiments.

[0010] Figure 2B is a rear elevation view of the surgical box of Figure 2A according to some embodiments.

[0011] Figure 2C is a side cross-sectional view of a pump assembly for use with the surgical box of Figure 2A, according to some embodiments.

[0012] Figure 2D is a side cross-sectional view of the pump assembly of Figure 2C connected to the surgical box of Figure 2A according to some embodiments.

[0013] Figure 2E is another side cross-sectional view of the pump assembly of Figure 2C connected to the surgical box of Figure 2A according to some embodiments.

[0014] Figure 3A is a top-side isometric view of an exemplary pump assembly according to some embodiments, which can be operatively coupled to a surgical cartridge, such as the surgical cartridge of Figure 2A.

[0015] Figure 3B is a side cross-sectional view of the pump assembly of Figure 3A according to some embodiments.

[0016] Figure 3C is a side cross-sectional view of the pump assembly of Figure 3A connected to the surgical box of Figure 2A according to some embodiments.

[0017] Figure 3D is a side cross-sectional view of the pump elastomer of Figure 3A connected to the surgical box of Figure 2A according to some embodiments.

[0018] Figure 4A is a rear isometric view of a surgical box according to some embodiments, showing an exemplary pump base portion.

[0019] Figure 4B is a side cross-sectional view of an exemplary pump base portion of Figure 4A according to some embodiments.

[0020] For ease of understanding, the same reference numerals have been used where possible to refer to the same elements common to the figures. It is contemplated that elements and features of one embodiment can be advantageously combined in other embodiments without further description. Detailed Implementation

[0021] This disclosure will now be described in detail with reference to the accompanying drawings, which are provided as illustrative examples to enable those skilled in the art to practice this disclosure. It is important to note that the drawings and examples below are not intended to limit the scope of this disclosure to a single embodiment, and other embodiments are possible through substitution of some or all of the elements described or shown. Furthermore, where certain elements of this disclosure are implemented partially or entirely using known components, only those portions of such known components necessary for understanding this disclosure will be described, and detailed descriptions of other portions of such known components will be omitted so as not to obscure the disclosure.

[0022] This disclosure generally relates to ophthalmic surgical kits, their components, and methods of use. During certain ophthalmic surgeries, surgical kits can be used to facilitate aspiration / lifting and infusion / irrigation related to the patient's eye. Typically, such surgical kits include one or more pump assemblies configured to engage with a roller pump head on a surgical console to generate a flow source. Each pump assembly may include a pump elastomer disposed on and sealing a segmented fluid chamber or volume, and the pump elastomer, upon engagement with the roller pump head, causes fluid within the volume to be driven in a first or second direction, thereby generating downstream pressure and / or vacuum.

[0023] In many current surgical cartridge designs, the pump elastomer comprises an annular silicone rubber material overmolded onto a rigid plastic substrate ring (e.g., the base of the pump elastomer). However, the implementation of a rigid substrate ring and silicone rubber overmolded part leads to sealing problems due to the fixed boundary conditions generated by the substrate ring. These sealing problems result in leakage paths and impaired performance, which will be discussed in detail below.

[0024] For example, some pump elastomers are integrated into a non-separable assembly (two-shot molding) consisting of a silicone rubber overmolded part and a plastic substrate ring. This two-shot design is superior to the previous single-shot design. However, under compression, the elastic silicone rubber of the existing design may impede the sealing interface between different segments or chambers of the pump assembly. Furthermore, under compression, the silicone rubber may not have the freedom of movement in the lateral direction as the roller pump head passes by. As a result, the silicone rubber may fold at the corners of the pump elastomer under compression and create voids that can act as leakage paths.

[0025] Accordingly, some embodiments described herein provide a pump elastomer having one or more grooves formed in, for example, its outer surface, to provide enhanced sealing to an underlying segmented fluid volume. These grooves facilitate displacement of silicone rubber and other elastomeric materials under compression. This silicone rubber displacement promotes a leak-free seal, which will be described in detail below. In some embodiments, the pump assembly includes a base that engages with the pump elastomer and includes sealing ribs. According to some embodiments, adding sealing ribs to the base advantageously fills corner gaps that could lead to leakage paths, which will be described in further detail below.

[0026] Referring now to Figures 1 and 2, Figure 1 illustrates an example of an ophthalmic surgical system 10 that can be used to perform ophthalmic surgery on the eye according to some embodiments. In the illustrated embodiment, system 10 includes a console 100 (also referred to as a "surgical console"), an interface device 107 (e.g., a foot pedal), and a handheld device 112. The console 100 includes a housing 102, a fluid control subsystem 110, and a display screen 104, the housing housing housing a computer and the subsystem.

[0027] In some embodiments, the handpiece 112 can be any suitable ophthalmic surgical instrument (e.g., an ultrasound-driven phacoemulsification handpiece, a laser handpiece, an irrigation cannula, a vitrectomy handpiece, or another suitable surgical handpiece). The fluid control subsystem 110 provides fluid control for one or more handpieces 112 (112a-c). For example, the fluid control subsystem 110 can manage the fluid used for the irrigation cannula.

[0028] Figures 2A and 2B illustrate an exemplary surgical cartridge 200 for use with the embodiments described herein. The surgical cartridge 200 can be operatively coupled to the console of an ophthalmic surgical system (e.g., the console 100 of the ophthalmic surgical system 10 shown in Figures 1A and 1B). Figure 2A is a rear isometric view of the surgical cartridge 200 according to some embodiments. Meanwhile, Figure 2B is a rear elevation view of the surgical cartridge 200 of Figure 2A according to some embodiments. For clarity, Figures 2A and 2B are described together herein.

[0029] 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).

[0030] The surgical cartridge 200 has a housing 205 having a base 206, a cover assembly 208 coupled to the base 206, and inlet / outlet ports 210 (210a-c) in the base 206, which provide pressure and / or fluid communication between the internal and external environments of the housing 205. Although not shown, each port 210a-c may be connected to a flow line (e.g., a fitting) between it and a corresponding component of the fluid control subsystem 110 and / or a corresponding handheld device 112 (shown in FIG. 1A).

[0031] 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 or delivery), while the other of the first pump assembly 202a or the second pump assembly 202b provides a vacuum source (e.g., to generate a driving force for fluid suction or extraction). The first pump assembly 202a and the second pump assembly 202b may comprise a peristaltic pump 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.

[0032] In certain ophthalmic surgeries, the surgical cartridge 200 plays a crucial role in facilitating aspiration, suction, infusion, or irrigation within the patient's eye. Pump assemblies 202a and 202b of the surgical cartridge 200 engage with a roller pump head in the surgical console 100. The engagement of the roller pump head and pump assemblies 202a and 202b creates a pressure and / or vacuum source used during the procedure. Each pump assembly 202a and 202b includes a pump elastomer 203 (shown as 203a and 203b, corresponding to each assembly 202a and 202b, respectively) that seals a fluid chamber between the pump elastomer 203 and a portion of a base 206. Hereinafter, the portion of the base 206 that engages with each pump elastomer 203 is referred to as "base portion 201" (shown as 201a and 201b, corresponding to each assembly 202a and 202b, respectively).

[0033] In some embodiments, the fluid chamber between each pump elastomer 203 and the base 206 is segmented, and this segmentation may be provided by one or more features formed in the pump elastomer 203. When engaged with a roller pump head, the rollers of the roller pump head abut against the pump elastomer, providing manual force to drive the fluid in the fluid chamber in either direction, thereby generating downstream pressure or vacuum as needed.

[0034] As shown in Figures 2A and 2B, in some embodiments, the pump elastomer 203 may be annular or ring-shaped, corresponding to the rotation path of the rollers of the roller pump head of the fluid control subsystem 110 of the console 100. The annular shape of the pump elastomer 203 allows the rollers of the roller pump head to roll along the outer surface 244 of the pump elastomer 203 while pressing against it, thereby propelling fluid in one direction or the other and creating a vacuum or pressure in the corresponding fluid lines (e.g., 210a, 210b and / or 210c) connected to the pump assemblies 202a, 202b. Therefore, the connection of each pump elastomer 203 to the substrate ring 220 (220a and 220b are shown in Figures 2A and 2B) is advantageous for effective sealing. In some embodiments, the pump elastomer 203 may be segmented as a single unit, or in other embodiments, segmented by elastomer walls between segments. This segmentation ensures that each segment functions independently while maintaining the overall integrity of the elastomer.

[0035] A valve assembly 204 is disposed within the base 206 of the casing. The valve assembly 204 functions cooperatively to control pressure and / or fluid communication within and through the surgical casing 200. The valve assembly 204 can be operated to selectively direct fluid flow between multiple channels of the housing 205. The pump assembly 202 and the valve assembly 204 are located on the rear side 212 of the casing base 206, as can be seen in Figures 2A and 2B. The surgical casing 200 includes pump assemblies 202a and 202b that are identical to each other.

[0036] Turning to Figures 2C and 2D, Figure 2C depicts a side section of pump assembly 202a taken along line 240 of Figure 2B, and Figure 2D depicts a side section of pump assembly 202a taken along line 240 when assembled with the corresponding base portion 201a of housing base 206. For clarity, Figures 2C and 2D are described together herein.

[0037] As shown in the figure, pump assembly 202a includes a pump elastomer 203a. The pump elastomer 203a can be formed from any flexible and elastic polymer material suitable for ophthalmic pump systems. For example, the pump elastomer 203a includes elastic properties that help conform to the contours of the pump roller head as it rolls along the pump elastomer 203a to drive fluid in the pump assembly 202a, thereby maintaining a strong and leak-free seal during use. In some embodiments, the pump elastomer 203 can be made of silicone rubber and / or fluorosilicone elastomers.

[0038] The pump elastomer 203a of the pump assembly 202a includes two sealing extensions 213 extending laterally downward from opposite sides of the pump elastomer 203a. The sealing extensions 213 are configured to engage with corresponding sealing recesses 234 of the base portion 201a to facilitate a fluid seal between the pump assembly 202a and the base portion 201a. Similarly, the substrate ring 220a includes two annular extensions 221 extending downward from the substrate ring 220a. The annular extensions 221 are configured to engage with corresponding annular recesses 236 of the base portion 201a (e.g., at the bottom of the annular extensions 221) to ensure a secure and conformal placement of the pump assembly 202a and the base portion 201a. As an example, the substrate ring 220a is configured to be ultrasonically welded to the base 206, such that a permanent weld joint can exist at the surface of the annular extensions 221 that contacts the surface of the annular recesses 236 of the base portion 201a. The pump elastomer 203a can be fixed to the base 206 by ultrasonically welding the substrate ring 220a to the base 206.

[0039] In some embodiments, the base portion 201a further includes a boss 230 disposed between the sealing recesses 234 and a protrusion 232 disposed between the sealing recesses 234 and the annular recesses 236. The boss 230, together with the inner surface 242 of the pump elastomer 203a, defines a fluid chamber 209 through which fluid can flow during use of the surgical cartridge 200 when driven by mechanical force provided by the rollers of the roller pump head abutting against the outer surface 244 of the pump elastomer 203a. The fluid chamber 209 is generally sealed by the interaction of the inner surface 242 of the pump elastomer 203a against the opposing edges 214 of the boss 230, and further sealed by these sealing extensions when sealing extensions 213 are disposed in the sealing recesses 234. During installation, as the pump elastomer 203a engages with the base portion 201a and is further compressed (i.e., pressed into the base portion 201a), the sealing extension 213 fills the sealing recess 234, thereby creating a substantially permanent airtight seal.

[0040] The boss 230 serves as a sealing plane for the fluid chamber 209 and restrains the vertical displacement of the pump elastomer 203a during operation. In some embodiments, the boss 230 serves as a pressing boundary (or wall) for the pump elastomer 203a, thereby creating a seal. Positioning the protrusion 232 and the sealing extension 213 on opposite sides of the boss 230 further ensures that the pump elastomer 203a remains properly aligned with the base portion 201a during installation. That is, radial alignment can be achieved between the sealing extension 213 and the sealing recess 234.

[0041] Figure 2E depicts a side section of the pump assembly 202a under compressive force (e.g., applied by the rollers of the roller pump head) on its outer surface 244, as simulated by a finite element analysis (FEA) simulation. FEA is a numerical method used to simulate and analyze the behavior of materials, structures, and systems under various conditions, such as loads, temperature variations, or other external influences. FEA can be used to create detailed simulations and models of materials, structures, and / or systems (e.g., Figure 2E).

[0042] In the context of pump assembly 202a, FEA can be used to analyze stress distribution, deformation, and other mechanical properties to optimize the design and performance of pump elastomer 203a. By simulating how the elastomeric material of pump elastomer 203a responds to various forces and conditions, potential design modifications can be made to improve the overall performance and reliability of the device. Therefore, compression simulation helps identify potential weaknesses in the design and areas requiring optimization.

[0043] For example, pump elastomer 203a is coupled to substrate ring 220a and base 206. Substrate ring 220a is a rigid structure made of, for example, plastic (or, in some embodiments, a metal alloy). Substrate ring 220a provides a robust and stable structure for pump elastomer 203a, thereby firmly anchoring it in place on base 206. The inherent rigidity of substrate ring 220a can limit the lateral deformation (or lateral movement) of pump elastomer 203a. Therefore, due to the coupling of substrate ring 220a to pump elastomer 203a, lateral deformation of the elastomeric material of pump elastomer 203a may be hindered by the rigidity of substrate ring 220a. When the roller pump head applies pressure to the outer surface 244 of pump elastomer 203a, the elastomeric material of pump elastomer 203a is compressed and attempts to deform in response to the compressive force. However, due to the tight coupling with substrate ring 220a, pump elastomer 203a may be restricted and difficult to move laterally or laterally easily in some examples.

[0044] The combination of corresponding features of the substrate ring 220a, pump elastomer 203a, and base portion 201a creates a robust sealing mechanism for the fluid chamber 209. The substrate ring 220a provides the necessary stability and rigidity, while the pump elastomer 203a, through its elastic properties, can deform and adapt to the pressures applied during operation of the surgical cartridge 200. Connecting the pump elastomer 203a to the substrate ring 220a is crucial for maintaining the overall integrity of the pump elastomer 203a and preventing leakage and / or bursting under high positive pressure. However, without features that promote lateral deformation under compression, the pump elastomer 203a may be subjected to excessive stress, potentially creating leakage paths, which will be discussed further below.

[0045] As shown in Figure 2E, FEA simulations demonstrate that the deformation of the pump elastomer 203a is limited by fixed boundary conditions on each side of the pump elastomer 203a, generated by the substrate ring 220a. Therefore, when the pump elastomer 203a is under compression, the substrate ring 220a prevents any lateral material deformation of the pump elastomer 203a. Consequently, folds and / or lifts may form at the edge 214 of the boss 230, causing separation and creating a leakage path 211 for the fluid in the fluid chamber 209, as shown in Figure 2E. Accordingly, the embodiments described herein mitigate this limitation caused by the fixed boundary conditions. For example, this limitation can be mitigated by implementing grooves and / or sealing ribs, which will be described in detail below.

[0046] Referring now to Figures 3A through 3D, which depict an improved pump assembly 302 according to one or more embodiments herein. In some embodiments, the pump assembly 302 is configured for use with a surgical cartridge 200 or a similar surgical cartridge used in an ophthalmic surgical system 10, as discussed above. Accordingly, in some examples, the pump assembly 302 is depicted assembled with a base portion 201a.

[0047] Overall, pump assembly 302 offers significantly improved performance and accuracy compared to other pump assemblies. For example, pump assembly 302 can provide improved sealing for fluid flowing through one or more sections (e.g., chambers) of pump assembly 302, thereby mitigating or eliminating any loss of internal pressure. Maintaining internal pressure ensures smooth and efficient fluid delivery (e.g., suction / aspiration or infusion / infusion) during ophthalmic procedures using system 10 and / or handpiece 112.

[0048] As shown in Figures 3A and 3B, in some embodiments, the pump assembly 302 includes a substrate ring 320 coupled to a pump elastomer 303, which, together with the substrate ring, is configured to engage a base portion of the surgical cartridge base (base portion 201a is shown). The pump elastomer 303 includes an outer surface 344 having a recess 306 and an inner surface 342, the inner surface defining a fluid chamber 309 together with a boss 230 of the base portion 201a. During use of the surgical cartridge 200, fluid can flow through this fluid chamber when driven by mechanical forces provided by the rollers of the roller pump head abutting against the outer surface 344 of the pump elastomer 303. The inner surface 342, together with the boss 230 and its edge 214, seals the fluid chamber 309. In some embodiments, the fluid chamber 309 includes one or more segmented volumes arranged along the circumference of the pump elastomer 303 and the boss 230, such as those formed by one or more features (e.g., walls) in the pump elastomer 303 and / or the base portion 201a.

[0049] Similar to pump elastomer 203a, pump elastomer 303 includes two sealing extensions 313 extending laterally downward from opposite sides of pump elastomer 303. The sealing extensions 313 are configured to engage corresponding sealing recesses 234 of base portion 201a to facilitate a fluid seal between pump assembly 302 and base portion 201a. Similarly, substrate ring 320 includes two parallel annular extensions 321 extending downward from substrate ring 320. The annular extensions 321 are configured to engage corresponding annular recesses 236 of base portion 201a (e.g., at the bottom of the annular extensions 321) to ensure a secure and conformal placement of pump assembly 302 to base portion 201a. As an example, substrate ring 320 is configured to be ultrasonically welded to base 206, such that a permanent weld joint can exist at the surface of the annular extension 321 that contacts the surface of the annular recess 236 of base portion 201a. The pump elastomer 303 can be fixed to the base 206 by ultrasonically welding the substrate ring 320 to the base 206.

[0050] The fluid chamber 309 is typically sealed by the interaction of the inner surface 342 of the pump elastomer 303 against the opposing edges 214 of the boss 230, and further sealed by these sealing extensions when they are disposed in the sealing recess 234. During installation, as the pump elastomer 303 engages with the base portion 201a and is further compressed (i.e., pressed into the base portion 201a), the sealing extensions 313 fill the sealing recess 234, thereby creating a substantially permanent hermetic seal. The boss 230 serves as a sealing plane for the fluid chamber 309 and restrains vertical displacement of the pump elastomer 303 during operation.

[0051] The pump elastomer 303 can be formed of any flexible and elastic polymer material suitable for ophthalmic pump systems and is configured to facilitate a tight seal against fluid disposed in the fluid chamber 309. For example, the pump elastomer 303 includes elastic properties that help conform to the contours of the pump roller head as it rolls along the pump elastomer 303, thereby maintaining a strong and leak-free seal during use. In some embodiments, the pump elastomer 303 may be made of silicone rubber and / or fluorosilicone elastomers.

[0052] Pump elastomers 203 and 303 can be configured to perform the same function within the surgical cassette 200 (including creating a robust seal for the fluid chamber within the surgical cassette 200) and to facilitate fluid flow during ophthalmic surgery in response to movement of the roller pump head. For example, both pump elastomers 203 and 303 are annular or ring-shaped to conform to and align with the circular path of the roller pump head of the fluid control subsystem 110 in the surgical console 100. The annular shape allows the roller pump head to roll continuously and efficiently along the respective pump elastomer, thereby propelling fluid in the desired direction and creating a vacuum or pressure in the fluid lines connected to the respective pump assembly. Pump elastomer 303 (regardless of the presence of the groove 306) is made of a flexible material such as silicone rubber, capable of withstanding repeated compression and release cycles as the roller pump head moves across the outer surface 344. The flexibility of pump elastomer 303 is advantageous because flexure allows pump elastomer 303 to deform under pressure and then return to its original shape once the pressure is released.

[0053] The primary difference between pump elastomer 203 and pump elastomer 303 lies in the presence of a groove 306 in the outer surface 344 of pump elastomer 303. The groove 306 incorporated into the design of pump elastomer 303 provides significant benefits in terms of sealing and device performance. The groove 306 on the elastomer surface promotes lateral deformation of pump elastomer 303 under compression, thereby improving the sealing capability of pump assembly 302 and overall device performance. For example, in response to the compressive force applied by the roller pump head, pump elastomer 203 without grooves can only shift vertically under compression, which may lead to increased stress at the interface between pump elastomer 203 and substrate ring 220, as well as potential leakage paths. In contrast, pump elastomer 303 with groove 306 promotes lateral deformation of the elastomer material under compression, thereby improving sealing and reducing or eliminating potential leakage paths (e.g., 211).

[0054] Turning to Figure 3D, during operation of the pump assembly 302, the pump elastomer 303 undergoes compression, such as that caused by the roller pump head rolling along the outer surface 344 of the pump elastomer 303, to deliver fluid contained within the fluid chamber 309 formed between the pump elastomer 303 and the base portion 201a, and to generate vacuum and / or pressure. The groove 306 facilitates lateral deformation of the pump elastomer 303 under compression, thereby helping to maintain a tight fluid seal between the base portion 201a and the pump elastomer 303.

[0055] For example, when the pump elastomer 303 is compressed due to the action of the roller pump head (e.g., FIG. 3D), the elastomeric material of the pump elastomer 303 needs to displace to accommodate the applied compressive force. The groove 306 provides a channel or space (i.e., a void, groove, and / or recess) for the deformation or expansion of the elastomeric material, allowing the elastomeric material of the pump elastomer 303 to laterally displace. This lateral deformation allows the pump elastomer 303 to maintain contact with the base portion 301, thereby improving the overall seal and reducing the chance of leakage at the interface between the base portion 201a and the pump elastomer 303.

[0056] Without the groove 306, the elastomeric material has limited space to move when compressed, which could lead to increased stress and potential leakage at the interface between the pump elastomer 303 and the base portion 201a. Compared to the absence of a groove, the groove 306 effectively reduces the compressive force required for lateral deformation of the pump elastomer 303 while maintaining a robust seal with the base portion 201a. By providing a channel for lateral deformation, the groove 306 helps maintain leak-free contact between the pump elastomer 303 and the base portion 201a.

[0057] Reducing or eliminating leakage paths enhances the overall performance of the surgical cartridge 200 during surgery. For example, reducing or eliminating leakage paths ensures the maintenance of intraocular pressure within the patient's eye, while providing smooth and efficient fluid flow during ophthalmic surgery. This contributes to safer and more effective patient outcomes. The groove 306 further enhances fluid control, improves device reliability, and extends device lifespan, ultimately leading to better patient care and more successful surgical results.

[0058] In some embodiments, the groove 306 is advantageously positioned on the outer surface 344 of the pump elastomer 303, as shown in FIG3A. The depth, spacing, and / or arrangement of the groove 306 affect its effectiveness in promoting lateral deformation and improving the seal between the base portion 201a and the pump elastomer 303. Accordingly, in some embodiments, the groove 306 includes a shape, depth, spacing, and / or arrangement that promotes optimal lateral deformation of the pump elastomer 303 under compression.

[0059] For example, the groove 306 is deep enough to allow sufficient lateral deformation, but not deep enough to compromise the integrity or durability of the pump elastomer 303. In some embodiments, the depth of the groove 306 may be substantially between 0.1 mm and 4.0 mm (e.g., between 0.1 mm and 3.0 mm, 0.1 mm and 2.0 mm, or 0.1 mm and 1.0 mm), and the width of the groove 306 may be substantially between 0.02 mm and 1.50 mm (e.g., between 0.03 mm and 1.40 mm, 0.04 mm and 1.30 mm, or 0.05 mm and 1.20 mm). In some embodiments, the depth of the groove 306 may be 0.64 mm, 1.0 mm, 1.5 mm, 2.0 mm, 2.5 mm, or 2.9 mm. In some embodiments, the groove 306 comprises a uniform depth, while in other embodiments, the groove 306 may comprise a tapered depth that begins flush with the surface and gradually deepens to its full depth.

[0060] In some embodiments, the position and size of the grooves 306 are advantageously configured to achieve optimal lateral deformation of a specific elastomeric material (e.g., silicone rubber) of the pump elastomer 303. The optimal displacement can be determined via FEA simulations discussed above. The spacing between the grooves 306 ensures that the grooves 306 effectively reduce stress and compressive forces on the pump elastomer 303. This positioning of the grooves 306 facilitates uniform and efficient lateral expansion, thereby providing a leak-free seal between the pump elastomer 303 and the base portion 201a, as shown in Figure 3D.

[0061] In some embodiments, the arrangement of the recesses 306 may differ from that shown in Figures 3A to 3D, depending on the specific design and application of the surgical cartridge. For example, in some embodiments, the recesses 306 may be arranged as concentric circles, as shown in Figure 3A. In some embodiments, the recesses 306 may be parallel grooves or beveled grooves, or other patterns selected for the pump elastomer 303. The optimal arrangement of the recesses 306 on the pump elastomer 303 will depend on several factors, such as the geometry of the chambers within the surgical cartridge (e.g., 200), the fluid dynamics within the fluid control subsystem 110 of system 10, and other desired performance characteristics.

[0062] Therefore, the groove 306 reduces stress and compressive forces on the pump elastomer 303, thereby reducing the likelihood of localized stress concentration. This reduction helps extend the life of the pump elastomer 303 by minimizing wear and tear, ultimately extending the overall life of the surgical cartridge (e.g., surgical cartridge 200). Furthermore, the enhanced sealing and reduced wear provided by the groove 306 contribute to improved device reliability. Surgeons can have greater confidence in the performance and consistency of the surgical console 100 during ophthalmic procedures, which is crucial for ensuring patient safety and optimal surgical outcomes.

[0063] Figure 4A depicts a rear isometric view of the surgical cartridge 400, with one pump assembly 402 removed to expose the base portion 401 beneath the base 406, while another pump assembly 402 is attached to the corresponding base portion 401. Figure 4B shows a side sectional view of the exposed base portion 401 of the base 406. Accordingly, for clarity, this description will be combined with Figures 1 through 3D and Figures 4A through 4B.

[0064] Base portion 401 is an embodiment of base portions 201 and 301, and similarly labeled parts and their reference numerals correspond to similar features having similar functions. In some embodiments, base portion 401 includes features that enhance the sealing and performance of the corresponding pump assembly. Base portion 401 is configured to interface with a pump elastomer of the pump assembly (e.g., pump elastomer 403 of pump assembly 402 shown in FIG. 4A) to contain or seal fluid between base portion 401 and pump elastomer 403. Pump elastomer 403 is an embodiment of pump elastomers 203 and 303, and similarly labeled parts and their reference numerals correspond to similar features having similar functions.

[0065] In some embodiments, the base portion 401 includes a boss portion 430, sealing ribs 408 positioned on opposite sides of the boss portion 430, a base recess 434, an annular recess 436, and a protrusion 432 (as shown in FIG4B). Typically, the sealing ribs 408 contribute to enhanced sealing capability and overall performance of the pump assembly 402, particularly the pump elastomer 403 of the pump assembly 402.

[0066] In some embodiments, the sealing rib 408 may be advantageously positioned to fill (i.e., block, obstruct) leakage paths at the interface between the pump elastomer 403 and the base portion 401 when the pump elastomer 403 is engaged with the base portion 401, thereby preventing fluid from leaking from, for example, a fluid chamber between the pump elastomer 403 and the base portion 401 (e.g., fluid chamber 309 in FIG. 3B) into the surrounding space. For example, the sealing rib 408 is configured to fill potential voids at the interface between the pump elastomer 403 and the base portion 401 that correspond to leakage paths formed during compression of the pump assembly 402 (e.g., leakage path 211 in FIG. 2D).

[0067] Positioning the sealing rib 408 on the base portion 401 helps maintain a leak-free seal, thereby ensuring smooth and efficient fluid flow during ophthalmic surgery using the surgical console 100. For example, the sealing rib 408 conforms to the geometry of the corner at the interface between the pump elastomer 403 and the base portion 401, and prevents separation and lifting during pumping, thereby enhancing the overall performance of the surgical cartridge 400 during surgery. By anticipating such separation and lifting of the pump elastomer, the sealing rib 408 pre-blocks any potential leakage paths (e.g., leakage path 211 in Figure 2D) that could otherwise compromise the performance of the surgical cartridge 400.

[0068] As best seen in Figure 4B, the boss portion 430 partially defines a fluid chamber or segment (e.g., fluid chamber 309 in Figure 3B) between the pump elastomer 403 and the base portion 401. Protrusions 432 may be positioned on opposite sides of the boss portion 430, as shown in Figure 4B. The boss portion 430 serves as a sealing plane, restraining vertical displacement of the pump elastomer 403 during operation. Positioning the protrusions 432 on opposite sides of the boss portion 430 ensures that the pump elastomer 403 remains properly aligned with the base portion 401 during installation. The base portion 401 further has a base recess 434 that aligns with a sealing extension on the pump elastomer 403 (see sealing extension 313 in Figure 3B).

[0069] During installation, as the pump elastomer 403 engages with the base portion 401 and is further compressed (i.e., pressed into the base portion 201a), the sealing extension of the pump elastomer 403 (e.g., 313) fills into the base recess 434, thereby creating a permanent airtight seal. A sealing rib 408 is positioned on the base portion 401 to fill any remaining gaps at the interface between the pump elastomer 403 and the base portion 401, particularly at the edges of the boss portion 430 (e.g., at the corners of the fluid chamber 309 when the pump elastomer 403 engages with the base portion 401), locations that could potentially create leakage paths during use. By conforming to the geometry of the pump elastomer 403 and the corners of the fluid chamber 309, the sealing rib 408 ensures a more comprehensive and robust seal, thereby enhancing the overall performance of the surgical case.

[0070] As described above, in some embodiments, the base portion 401 may include a sealing rib 408. In some embodiments, the sealing rib 408 may include a height of substantially 0.25 mm and a width of substantially 0.74 mm. In some embodiments, the radius of curvature (R) of the sealing rib 408 may be equal to substantially 0.10 mm. In some other embodiments, the height, width, and radius of curvature of the sealing rib 408 may be less than or greater than 0.25 mm, 0.74 mm, and 0.10 mm, respectively.

[0071] In some embodiments, the height, width, arrangement, and shape of the sealing rib 408 may vary compared to those shown in Figures 4A to 4B. For example, in some embodiments, the height, width, arrangement, and shape of the sealing rib 408 may be selected to maximize its effectiveness in filling leakage paths, preventing separation and lifting, and improving the sealing capability and overall performance of the surgical cartridge. Because the height of the sealing rib 408 affects its ability to fill leakage paths, it is advantageous to select its height to conform to the corner geometry of the pump elastomer 403 in order to fill leakage paths and create an effective seal. However, the sealing rib 408 does not interfere with or impair the integrity of the pump elastomer 403.

[0072] In some embodiments, the sealing ribs 408 may be placed uniformly or in a pattern that maximizes engagement with the pump elastomer 403. For example, the sealing ribs 408 may comprise continuous ridges or integral sealing ribs. In some embodiments, the sealing ribs 408 may be organized into linear, circular, or other patterns to ensure complete engagement with the pump elastomer 403. The arrangement and pattern of the sealing ribs 408 ultimately depend on the specific design of the pump elastomer and the presence and severity of any leakage paths discovered during use, the geometry of the interface between the pump elastomer and the surgical cartridge housing, and the desired sealing performance. Therefore, the sealing ribs 408 help improve the seal by conforming to the geometry of the leakage path interface and create a stronger and more effective seal for the surgical cartridge 400. Improved sealing capability directly impacts the overall performance of the device, resulting in more accurate and consistent fluid flow, which is crucial for patient safety and surgical success.

[0073] Therefore, by implementing one or more embodiments described herein, surgeons can have greater confidence in the performance and consistency of the ophthalmic surgical system (e.g., 10) during ophthalmic surgery, which is crucial for ensuring patient safety and optimal surgical outcomes. The embodiments described herein provide a surgical case with improved pump elastomer seals by modifying the multi-chamber pump elastomer to enhance sealing and prevent such leakage. Improvements in the groove and sealing rib design, along with methods for diagnosing and implementing these improvements, provide an effective solution to sealing problems inherent in conventional pump elastomer designs.

[0074] In the claims, any reference numerals in parentheses should not be construed as limiting the claims. The words “comprising” or “including” do not exclude the presence of elements or steps other than those listed in the claims. In an apparatus claim listing several devices, several of these devices may be implemented by the same hardware. The word “a” or “an” preceding an element does not exclude the presence of a plurality of such elements. In any apparatus claim listing several devices, several of these devices may be implemented by the same hardware. The fact that certain elements are recited in different dependent claims does not indicate that these elements cannot be used in combination.

[0075] While the description provided above is based on embodiments currently considered most practical and preferred, and details are provided for illustrative purposes, it should be understood that such details are for this purpose only, and this disclosure is not limited to the explicitly disclosed embodiments, but rather is intended to cover modifications and equivalent arrangements falling within the spirit and scope of the appended claims. For example, it should be understood that this disclosure envisions that one or more features of any embodiment may be combined with one or more features of any other embodiment to the extent possible.

Claims

1. A surgical box, comprising: Base; One or more chambers for storing fluid; A pump elastomer having a substrate ring and an elastomer seal configured to seal one or more chambers; and one or more grooves positioned on the elastomer seal, wherein the one or more grooves are configured to promote lateral deformation of a portion of the elastomer seal when the elastomer seal is compressed and engaged with the base, thereby reducing or eliminating leakage paths of the fluid at the interface between the elastomer seal and the base.

2. The surgical box as described in claim 1, wherein, The groove has a depth ranging from 0.1 mm to 2.0 mm.

3. The surgical box as described in claim 1, wherein, The elastomeric seal includes silicone rubber.

4. The surgical box as described in claim 1, wherein, The pump elastomer is a multi-chamber pump comprising at least two chambers.

5. The surgical box as described in claim 1, wherein, The pump elastomer is configured to produce an airtight seal.

6. The surgical box as claimed in claim 1, wherein, The grooves are evenly spaced apart from each other, and the grooves are positioned on the top surface of the elastomeric seal.

7. The surgical box as claimed in claim 1, wherein, The groove is configured to reduce stress and compressive force on the pump elastomer.

8. The surgical box as claimed in claim 1, wherein, The groove has a height ranging from 0.02 mm to 2.0 mm and a width ranging from 0.1 mm to 1.50 mm.

9. A surgical box, comprising: Base; One or more chambers for storing fluid; A pump elastomer having a substrate ring and an elastomer seal, wherein the pump elastomer is configured to seal one or more chambers; and a plurality of sealing ribs positioned on the base, wherein the plurality of sealing ribs are configured to fill the leakage path of the fluid at the interface between the elastomer seal and the base when the elastomer seal is compressed, thereby eliminating or reducing the leakage path and enhancing the performance of the surgical cartridge.

10. The surgical box as claimed in claim 9, wherein, The sealing rib has a height ranging from 0.02 mm to 2.0 mm.

11. The surgical box as claimed in claim 9, wherein, The radius of curvature (R) of the sealing rib is between 0.01 mm and 0.3 mm.

12. The surgical box as claimed in claim 9, wherein, The sealing ribs are arranged in a pattern corresponding to one or more corners of the base.

13. The surgical box as claimed in claim 9, wherein, The elastomeric seal includes silicone rubber.

14. The surgical box as claimed in claim 9, wherein, The pump elastomer is a multi-chamber pump comprising at least two chambers.

15. The surgical box as claimed in claim 9, wherein, The pump elastomer is configured to produce an airtight seal.

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