Apparatus for providing compression in ophthalmic surgical cartridges and methods of use thereof

Abstract

Embodiments herein provide a surgical cassette and a surgical console for ophthalmic perfusion or aspiration during a surgical procedure, the surgical cassette including a plurality of valve assemblies, where each valve assembly includes a retention ring coupled to a base of the surgical cassette, and a valve body disposed within a cavity defined within the retention ring, where the valve body is coupled to the base of the surgical cassette, the retention ring provides a compressive force to the valve body that in turn compresses at least a portion of the sealing material disposed on the valve body against a surface of the base. The surgical console includes a plurality of valve drive assemblies configured to apply an additional compressive force to the valve assemblies of the surgical cartridge. The valve drive assemblies may be individually or collectively actuated to provide additional compression to selected valve assemblies of the plurality of valve assemblies.

Description

Cross Reference to Related Applications

[0001] This application claims the benefit of and priority to U.S. Provisional Application Serial No. 63 / 594,699, filed October 31, 2023, the contents of which are incorporated by reference in their entirety. INTRODUCTION

[0002] Cataract surgery involves removing a cataract lens and replacing the lens with an intraocular lens (IOL). The cataract lens is typically removed by fragmenting the lens and aspirating the lens fragments out of the eye. The lens can be fragmented using, for example, an ultrasonic phacoemulsification probe, a laser probe, or another suitable instrument. During the procedure, the probe fragments the lens and the fragments are aspirated out of the eye through, for example, a hollow needle or cannula. Throughout the procedure, irrigation fluid is pumped into the eye to maintain intraocular pressure (IOP) to prevent the eye from collapsing.

[0003] During cataract surgery, a surgical cassette having one or more peristaltic pumps and / or venturi pumps and one or more valve assemblies can be operably coupled with a fluid control module of a surgical console to facilitate the aspiration and irrigation functions described above. Generally, the one or more valve assemblies of the surgical cassette are operable to control the application of pressure and vacuum generated by the one or more pumps during a surgical procedure.

[0004] However, conventional surgical cassettes have several significant drawbacks, including, for example, insufficient compression forces provided between a sealing material disposed on a valve and an inner surface within the surgical cassette over time, resulting in an inability to maintain a robust seal of each valve within the surgical cassette, and the like.

[0005] Accordingly, there is a need for improved surgical cassettes that address at least some of the aforementioned drawbacks. SUMMARY

[0006] In some embodiments, a surgical cartridge is provided for ophthalmic irrigation or aspiration during surgical procedures. The cartridge includes multiple valve assemblies, each comprising a retention ring coupled to a base of the cartridge and a valve body disposed within a cavity defined by the retention ring. The retention ring provides a compressive force to the valve body, which in turn compresses at least a portion of a sealing material disposed on the valve body against a surface of the base. According to some embodiments, in addition to the compressive force applied to the valve body by the retention ring, a surgical console also applies a compressive force to the same valve assembly. By providing compressive force from the surgical console instead of or supplementing the compressive force provided by each retention ring, the material constituting each valve assembly experiences less mechanical stress over time and thus has a longer effective service life. Furthermore, since at least a portion of the compressive force required to form a seal is provided by the surgical console, each valve assembly within the cartridge can be constructed of more common materials rather than more expensive specialty materials configured to self-maintain compression.

[0007] In some embodiments, a system is provided for providing compression from a surgical console to a surgical cartridge during surgical procedures. The system includes: at least one valve assembly disposed within the surgical cartridge; at least one valve actuation assembly disposed within the surgical console, the at least one valve actuation assembly configured to engage a valve body within the at least one valve assembly; and a clamping assembly disposed within the surgical console, the clamping assembly configured to apply a distal force to the surgical cartridge, wherein the at least one valve actuation assembly is further configured to apply a force to the at least one valve assembly in response to the distal force applied by the clamping assembly to compress a sealing material disposed at a first end of the valve body.

[0008] In some embodiments, a method is provided for a surgical console to provide a proximal force to a surgical cartridge during ophthalmic surgery, the method comprising: coupling the surgical cartridge to the surgical console; engaging a valve actuation assembly within the surgical console with a valve assembly within the surgical cartridge; applying a reaction force from the valve actuation assembly to a valve body within the valve assembly; and then compressing a sealing material disposed on a first end of the valve body.

[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] FIG. 1A Examples of ophthalmic surgical systems that can be used to perform ophthalmic surgery on the eye, according to certain embodiments, are shown.

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

[0013] FIG. 2A It is operablely connectable to, according to certain embodiments FIG. 1A An isometric view of the rear side of the surgical box of an example ophthalmic surgical system console.

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

[0015] FIG. 3 According to certain embodiments FIG. 2A and FIG. 2B An exploded perspective view of the surgical box shows the components, including each of the valve assemblies and each of the pump assemblies located within the surgical box.

[0016] FIG. 4A According to certain embodiments FIG. 2A and FIG. 2B An enlarged exploded front isometric view of a portion of the surgical box, showing an example valve assembly with two passages in the valve body.

[0017] FIG. 4B According to certain embodiments FIG. 2A An enlarged exploded rear isometric view of a portion of the surgical box, showing an example valve assembly with two passages in the valve body.

[0018] FIG. 5 Demonstrates certain embodiments FIG. 1A A frontal stereoscopic view of the fluid control subsystem of an ophthalmic surgical console, which includes a clamping assembly and multiple valve actuation assemblies.

[0019] FIG. 6 This illustrates the settings according to certain embodiments. FIG. 5 A schematic diagram of multiple valve actuation components within a fluid control subsystem, which actuate... FIGS. 2A-3 The valve assembly inside the surgical box applies a reaction compressive force.

[0020] FIG. 7 This illustrates the settings according to certain embodiments. FIG. 1A A schematic diagram of multiple valve actuation assemblies within the surgical console, which actuate valves to... FIGS. 2A-3 The valve assembly inside the surgical box applies compressive force provided by the actuator.

[0021] FIG. 8 This illustrates the settings according to certain embodiments. FIG. 1AA schematic diagram of multiple valve actuation assemblies within the surgical console, which actuate valves to... FIGS. 2A-3 The valve assembly inside the surgical box applies compressive force provided by the plate.

[0022] To facilitate understanding, the same reference numerals are used where possible to refer to the same elements common 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

[0023] This disclosure generally covers ophthalmic surgical kits, surgical control consoles, and their usage.

[0024] FIG. 1A Examples of an ophthalmic surgical system 10, which can be used to perform ophthalmic surgery on the eye according to certain embodiments, are shown. In the illustrated embodiment, the surgical system 10 includes components connected and referenced as shown. FIG. 1B The surgical 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 handpiece 112 (112a-c) are described in more detail.

[0025] FIG. 1B According to certain embodiments FIG. 1A An example of a subsystem of the surgical console 100 of an ophthalmic surgical system 10. The surgical 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 a handheld device 112. The interface device 107 receives input to the surgical system 10, sends output from the system 10, and / or processes the 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.

[0026] Handpiece 112 can be any suitable ophthalmic surgical instrument, such as an ultrasound-driven phacoemulsification 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 ultrasonic oscillations of the phacoemulsification handpiece, provide laser energy to the laser handpiece, control the operation of the irrigation cannula, and / or manage the features of the vitrectomy handpiece.

[0027] Computer 103 controls the operation of ophthalmic surgical system 10. In some embodiments, computer 103 includes a controller that sends instructions to components of surgical system 10 to control the surgical system 10. Display screen 104 displays data provided by computer 103.

[0028] FIG. 2A It is a console that can be operatively connected to an ophthalmic surgical system according to certain embodiments (e.g., FIGS. 1A-1B Isometric rear view of an example surgical box 200 of the surgical console 100 of the ophthalmic surgical system 10. FIG. 2B According to certain embodiments FIG. 2A The rear elevation view of the surgical box 200. For clarity, this article will... FIGS. 2A-2B Combined description. 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, also referred to as “valve”) 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).

[0029] 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.

[0030] 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-c) in the base 206, which provide pressure and / or fluid communication between the interior and exterior of the housing 205. In some embodiments, each port 210a-c corresponds to a corresponding component of the fluid control subsystem 110 and / or a corresponding handheld component 112a-c. FIGS. 1A-1B Flow lines (e.g., fittings) can be connected between (as shown).

[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), 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.

[0032] 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 FIG. 2A In one embodiment, four valve assemblies 204 are arranged at the four corners of the housing 205 and surround two pump assemblies 202 arranged toward the center of the housing 205. However, in some other embodiments, the pump assemblies 202 and valve assemblies 204 may have any other suitable arrangement.

[0033] As in FIG. 3 As seen in the exploded view, each pump assembly 202a, 202b is respectively coupled to and disposed within a first recess 308a and a second recess 308b defined within a base 206. Each recess 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 cartridge 200. Each pump assembly 202a, 202b includes a pump elastomer 302 disposed around the outer periphery of each recess 308a, 308b. A diaphragm 306 is disposed in the central portion of each recess 308a, 308b in a substantially nested or stacked configuration, the diaphragm being received or disposed below a diaphragm retention ring 304. In some embodiments, the diaphragm retention ring 304 is coupled to the inner surface of the recesses 308a, 308b by an ultrasonic welding process, wherein the diaphragm 306 is disposed below. The diaphragm retaining ring 304 thereby holds the diaphragm 306 within each corresponding recess 308a, 308b and provides an airtight seal with the base 206.

[0034] exist FIG. 4A and FIG. 4BThe figures show more details of the valve assembly 204 and its operation within the base 206, with top and bottom exploded perspective views of the third valve assembly 204c, respectively. Each valve assembly 204 typically includes a valve body 236 and a retaining ring 238 configured to be disposed in a corresponding bore 230, the retaining ring being used to retain the valve body 236 within the bore 230. The valve body 236 and the retaining ring 238 are assembled together in a stacked arrangement. The valve body 236 is disposed between a rear surface 234 and a corresponding retaining ring 238. The retaining ring 238 applies a retaining force on the corresponding valve body 236 to press the valve body 236 against the rear surface 234, as described in more detail below. In some other embodiments, instead of being defined within the base 206, each bore 230 may be defined within a corresponding retaining ring 238 assembled around the corresponding valve body 236. In some other embodiments, each valve body 236 may be rotatably coupled to the base 206 using a retaining cap. The retaining cap may be disposed through the valve body 236 (e.g., aligned with the longitudinal axis of the valve body 236). In such embodiments, each valve body 236 may be coupled to the base 206 without being disposed in a corresponding hole 230.

[0035] like FIG. 4A and FIG. 4B As seen, the valve body 236 of the third valve assembly 204c has a first end 240, a second end 242, a cylindrical outer surface 244 connecting the first end 240 and the second end 242, and a longitudinal axis 246 orthogonal to the first end 240. The cylindrical outer surface 244 includes a plurality of stepped portions with different external dimensions. In some embodiments, the cylindrical outer surface 244 includes a base portion 245 separate from the collar portion 247, the collar portion 247 having a larger diameter relative to the base portion 245, such as... FIG. 4A As best seen in the middle. In one embodiment, the base portion 245 has an approximate diameter of 13 mm and a longitudinal length of 5 mm, while the collar portion has an approximate diameter of 16 mm and a longitudinal length of 3 mm. The shoulder portion 249 transitions from the collar portion 247 to the sealing material 250.

[0036] The valve body 236 is rotatable about a longitudinal axis 246. In some embodiments, two passages 248 (248a-b) are formed in the valve body 236 at a first end 240, while in other embodiments, one passage may be formed in each valve body 236. FIG. 4A In this embodiment, when measured in the circumferential direction around the longitudinal axis 246, the lengths of the first passage 248a and the second passage 248b are approximately equal (e.g., extending approximately 140° to 150° circumferentially around the longitudinal axis 246). In the illustrated embodiment, the size of each passage 248 is determined to simultaneously open fluid communication with both ports of the base 206, as described below regarding...FIGS. 4A-4B More detailed description. In some other embodiments, the size of each passage 248 may be determined to simultaneously open fluid communication with any suitable number of ports (e.g., two, three, or four ports). In the illustrated embodiment, the passage 248 includes an arcuate annular segment extending circumferentially around a longitudinal axis 246. In some embodiments, the cross-section of the passage 248 may be circular, rounded, elliptical, polygonal, square, any other suitable shape, or a combination thereof. The terminating end of each passage 248 is defined through a first end 240 of the valve body 236. In some embodiments, the central axis of each passage 248 at its terminating end is parallel to the longitudinal axis 246. In some embodiments, at least a portion of each passage 248 (e.g., the portion between the terminating ends) is orthogonal to the longitudinal axis 246. In some embodiments, during manufacturing, the passages 248 are machined or molded in a direction parallel to the longitudinal axis 246, for example, starting from the first end 240. In other words, when viewed in a direction parallel to the longitudinal axis 246, the entire surface of each passage 248 is visible from the first end 240. In the illustrated embodiment, passage 248 includes equal or symmetrical flow areas. In some other embodiments, passage 248 may have different or asymmetrical flow areas. In some other embodiments, the valve body may have only one passage or more than two passages.

[0037] The valve body 236 includes a sealing material 250 at a first end 240 that rotatably contacts a rear surface 234 of the base 206 to seal the first end 240 against the rear surface 234. The seal between the first end 240 and the rear surface 234 forms a sealing interface between planar (e.g., non-cylindrical) surfaces. Because the sealing interface is located at the longitudinal end of the valve body 236 (i.e., the first end 240), this sealing arrangement can be referred to as an "end seal" or a "face seal." In some embodiments, the sealing material 250 is formed of a rubber or elastomeric material (e.g., silicone rubber) bonded (e.g., overmolded) to the valve body 236 at the first end 240. In some other embodiments, the valve body 236 and the sealing material 250 may be integrally formed of the same material (e.g., high-density polyethylene).

[0038] The retaining ring 238 has an annular body 254 with a central opening 256. The retaining ring 238 is fitted onto and surrounds the valve body 236, such that the drive interface 258 of the valve body 236 (in) FIG. 4BAs shown, a valve body 236 (also referred to as a "drive receiver") is received within a central opening 256. In some embodiments, the drive interface 258 engages the drive mechanism of the surgical console 100 to rotate the valve body 236 about a longitudinal axis 246. The annular body 254 includes a plurality of stepped portions with different external dimensions. At least one portion of the annular body 254 is radially disposed between the cylindrical outer surface 244 of the valve body 236 and the cylindrical inner wall 232c of the bore 230c. At least another portion of the annular body 254 is disposed outside the bore 230c. When the retaining ring 238 is fully seated in the bore 230c, the outer shoulder 260a formed between the stepped portions of the annular body 254 contacts the rear side 212 of the base 206. In some embodiments, a lubricant (e.g., silicone oil) may be used to facilitate relative rotation between the mating surfaces of the valve body 236 (e.g., rear surface 262) and the mating surfaces of the retaining ring 238 (e.g., inner shoulder 260b) and / or between the sealing material 250 and the rear surface 234. In some embodiments, one or more of the mating surfaces may be impregnated with a lubricant. In some embodiments, the lubricant may be any liquid that provides a lubricating coating and / or a hydrophobic coating.

[0039] The retaining force applied by the retaining ring 238 is applied axially in a direction parallel to the longitudinal axis 246, forcing the first end 240 of the valve body 236 toward the rear surface 234 of the base 206. This compresses the sealing material 250 against the rear surface 234, thereby forming a seal between the passage 248 and the corresponding port 252. In some embodiments, when the retaining ring 238 is fully seated in the bore 230c, the sealing material 250 is compressed up to 34% of its total height in a direction parallel to the longitudinal axis 246, thereby compressing or reducing the overall height to approximately 1 mm. In some embodiments, the retaining ring 238 is joined to the base 206 using a solid-state welding technique (e.g., ultrasonic welding) such that there is no gap or space between the inner shoulder 260b of the retaining ring 238 and the rear surface 262 of the valve body 236. In some other embodiments, the retaining ring 238 may be attached to the base 206, for example, by snap-fit, threaded connection, and / or adhesive. In some embodiments, the valve body 236 itself can be directly snap-fitted, threaded, and / or adhered to the base 206 without the need for a retaining ring 238.

[0040] In some embodiments, the valve body 236 includes a hard stop feature that can be used to associate the rotational state of the valve body 236 with either the base 206 or the retaining ring 238 to ensure proper alignment between the passage 248 and the corresponding port 252 during operation.

[0041] In some other embodiments, the hard stop feature may include one or more optical sensors or indicators respectively disposed on the valve body 236 and the retaining ring 238. For example, instead of physical contact between the valve body 236 and the retaining ring 238, the one or more optical sensors may indicate when a first maximum rotational position is reached between the valve body 236 and the retaining ring 238, thereby indicating to the system the current alignment or rotational position of the valve body 236 relative to the retaining ring 238 and / or the base 206.

[0042] In some embodiments, five ports 252 are formed through the lower wall 220. In operation, the valve body 236 is rotatable relative to the rear surface 234 of the base 206 to align each passage 248 with a corresponding port 252 (252a-e) of the base 206 to open pressure and / or fluid communication between corresponding passages of a plurality of channels defined in the base 206. The flow axis through each port 252 is parallel to the longitudinal axis 246 of the valve body 236. The shape of each port 252 may correspond to the cross-section of each passage 248 of the valve body 236 to help maintain flow through it. In some embodiments, the cross-sectional shape of each passage 248 may be formed by extending the shape of the corresponding port 252 to a swept surface through the valve body 236.

[0043] In the illustrated embodiment, five ports 252 are formed within each aperture 230 through the lower wall 220. However, any suitable number of ports (e.g., three to seven ports) may exist in each aperture 230. In the illustrated embodiment, the ports 252 include arcuate trapezoidal segments. In some other embodiments, the ports 252 may be circular, rounded, elliptical, polygonal, square, any other suitable shape, or a combination thereof. In the illustrated embodiment, the ports 252 have equal flow areas. In some other embodiments, the ports 252 may have different flow areas. In the illustrated embodiment, the ports 252 are uniformly spaced in the circumferential direction. In some other embodiments, the circumferential spacing of the ports 252 may be different.

[0044] In some embodiments, the clamp assembly 400 is integrated into the fluid control subsystem 110 of the surgical console 100, such as FIG. 5As shown. The clamp assembly 400 is disposed on the proximal or front portion of the fluid control subsystem 110, near the front surface of the surgical console 100. In some embodiments, the clamp assembly 400 is disposed behind the panel 406 of the fluid control subsystem 110 and above the drainage tray 410 coupled to the panel 406. The clamp assembly 400 is coupled to the panel 406 by a base pin 334, which inserts through each of the upper clamp mechanism 460 and the lower clamp mechanism 462 of the clamp assembly 400 and terminates in a corresponding orifice within a side portion or edge of the panel 406. The panel 406 includes a plurality of slots 412 defined through its surface, which in some embodiments are symmetrically defined vertically and horizontally about the panel 406. When the fluid control subsystem 110 is assembled, the clamp assembly 400 and panel 406 are aligned with each other such that the hooks 322 and distal portions of the first arm 318 and second arm 320 of the upper clamp mechanism 460 and lower clamp mechanism 462 are positioned to pass through and extend from corresponding slots 412. Each slot 412 is large enough to allow relative vertical movement of the hooks 322 and a degree of horizontal movement therein. In some embodiments, a pressure sensor 418 and a camera 420 are further disposed through panel 406 for monitoring the performance of the surgical cartridge during attachment. In some embodiments, the camera 420 is configured to read any barcodes on the surgical cartridge 200.

[0045] In some embodiments, such as FIG. 5 As shown, the frame 402 is attached to the front surface of the panel 406. The frame 402 has an opening or aperture defined therein, which is large enough to allow the surgical cartridge 200 to pass through it for removable attachment to the exposed panel 406. A button 404 located on the top portion of the frame 402 can be used to actuate the clamp assembly 400, as described in further detail below.

[0046] In some embodiments, the motor plate is positioned distally rearward of the clamp assembly 400. A motion plate motor 430 and a plurality of pump motors 436 are coupled to the motor plate. In some embodiments, the motion plate motor 430 includes a rotary motor pin 434 inserted through the motion plate. The pump motors 436 are coupled to the motor plate and extend through the interior of the motion plate of the clamp assembly 400 to engage each of a plurality of hub roller assemblies 422 disposed in the panel 406, which in turn are used to circulate or move fluid through the surgical cassette 200 when it is attached. An additional pressure sensor 424 for monitoring pressure within the cassette is disposed at or near each hub roller assembly 422.

[0047] In some embodiments, a plurality of valve actuation assemblies 500 are disposed within the fluid control subsystem 110. Each valve actuation assembly 500 includes a valve actuation motor 438, a valve actuation shaft 502 coupled to a proximal portion of the valve actuation motor 438, and a valve actuation head 504 coupled to a proximal end of the valve actuation shaft 502. Each valve actuation head 504 is configured to extend through or be disposed through the clamping assembly 400, while the valve actuation motor 438 of each valve actuation assembly 500 is held distal to the clamping assembly 400. The proximal portion of each valve actuation head 504 is inserted through the panel 406 and remains exposed to engage and actuate a corresponding plurality of valve assemblies 204 disposed within the surgical cartridge 200, as detailed below.

[0048] In some embodiments, the surgical cartridge 200 is first inserted into the fluid control subsystem 110 by orienting it above the panel 406 with the upper clamping mechanism 460 and the lower clamping mechanism 462 in the "closed" position (i.e., where the first arm 318 and the second arm 320 are oriented such that the corresponding hooks 322 are arranged adjacent to each other and facing opposite directions). When each clamping mechanism 460, 462 is in the "closed" position, this allows the surgical cartridge 200 to be positioned on or slide on the opposing hooks 322, i.e., by... FIG. 2A and FIG. 2B The corresponding slots 290, which are confined within the surgical box 200 as seen in the image, are provided on each hook 322, allowing the hook 322 to enter the interior portion of the surgical box 200.

[0049] In some embodiments, while inserting the clamping mechanisms 460, 462 into the surgical case 200, each of the valve assembly 204 and pump assembly 202 of the surgical case 200 is pressed against and then engaged with a corresponding plurality of valve drive heads 504 and a plurality of hub roller assemblies 422. For example, each of the valve drive heads 504 is inserted through an annular body 254 passing through a retaining ring 238 and then coupled to or otherwise engaged with a drive interface 258 provided on the second end 242 of the valve body 236 of the corresponding valve assembly 204. Each hub roller assembly 422 is then pressed against and in contact with a pump elastomer 302 corresponding to each pump assembly 202a, 202b. When each of the valve drive heads 504 engages with the valve body 236 of the corresponding valve assembly 204, a valve motor 438 is activated, which begins to rotate the valve drive shaft 502 relative to the valve body 236 in a clockwise or counterclockwise direction. Valve drive shaft 502 also rotates valve drive head 504 in the same direction of rotation, which causes valve body 236 to rotate within valve assembly 204, thereby opening, closing, or otherwise manipulating the fluid flow path connected to each valve assembly 204. In this way, valve assembly 204 within surgical cartridge 200 can be actuated by valve drive assembly 500 within fluid control subsystem 110 to provide the required aspiration or perfusion functions during ophthalmic surgery.

[0050] In some embodiments, when the clamp assembly 400 is actuated, the hooks 322 of each of the upper clamp mechanism 460 and the lower clamp mechanism 462 expand or open within a groove 290 defined within the surgical cassette 200, and enter into the hollow interior or cavity defined therein. The angled ends of the hooks 322 ensure that a portion of each hook 322 extends through and remains there within the surgical cassette 200, thereby preventing or at least minimizing any distal movement of the surgical cassette 200 relative to the surgical console 100. The hooks 322 further push the cassette against the panel 406, which ensures that engagement between the valve drive head 504 and the valve assembly 204 of the surgical cassette 200 is maintained, while also ensuring that the sealing material 250 disposed on the first end 240 of each valve body 236 is sufficiently compressed against the corresponding rear surface 234 of each corresponding hole 230. According to some embodiments, at least four valve assemblies 204 are present within the surgical cassette 200, each valve assembly providing a functional modality by closing and opening different fluid passages within the surgical cassette 200. Each valve body 236 within each valve assembly 204 includes a soft sealing material 250, which is molded onto a rigid base material via a secondary injection molding process. The sealing material 250 is compressed to maintain a seal within the surgical cartridge 200, at least partially, via a retaining ring 238. However, challenges exist associated with providing and maintaining valve compression. Specifically, the elastomers and other rigid polymers on the surgical cartridge 200, valve body 236, and retaining ring 238 undergo viscoelastic behavior (also known as stress relaxation and / or creep) after prolonged storage, which ultimately reduces valve compression and / or compressive force. To overcome these losses and potential seal loss, a target amount of compression must be applied to each valve body 236, compensating for compression losses and variations in part manufacturing tolerances over time. The compression and / or compressive force of the sealing material 250 is critical because it is directly related to the torque required to rotate the valve body 236 within the surgical cartridge 200. Specifically, when the sealing material 250 is compressed, a higher reaction force is provided by expanding the sealing material 250 into the port 252, thereby generating greater rotational resistance.

[0051] In contrast to retaining ring 238, the current embodiment aims to reduce the amount of valve compression required during the assembly of surgical cartridge 200 by relying on valve compression applied from surgical console 100. By providing compressive force from surgical console 100, the current embodiment avoids the application of high reaction forces on valve assembly 204 by retaining ring 238 during the lifespan of surgical cartridge 200. Applying high reaction forces on valve assembly 204 via retaining ring as used in previous designs requires retaining ring 238 to apply increased valve compression to compensate for compression losses, manufacturing tolerances, and / or part tolerances over time. Furthermore, high reaction forces on valve assembly 204 result in higher torque required to rotate valve assembly 204 and stress relaxation of the materials used within valve assembly 204. These problems, in turn, necessitate the use of stronger ultrasonic welding between retaining ring 238 and surgical cartridge 200 to withstand these reaction forces. For example, the ultrasonic welding process used to attach retaining ring 238 to surgical cartridge 200 requires increased force and custom equipment to compensate for compression losses over time. However, improper application of ultrasonic welding can lead to excessive compression and wear during the rotation of valve assembly 204. Furthermore, given the high reaction forces present within the valve, sufficient compression provided by the retaining ring 238 may be difficult to achieve without the use of "special materials." For example, the retaining ring 238 must be constructed from a special material capable of withstanding the high reaction forces on valve assembly 204 over time, thus increasing the overall cost of the surgical case. Therefore, according to some embodiments, in addition to the retaining ring 238 of valve assembly 204, according to... FIGS. 6-8 In some of the embodiments shown, the valve actuation assembly 500 of the current embodiment provides additional means for ensuring sufficient or proper compression of each valve assembly 204 to achieve its robust seal.

[0052] exist FIG. 6 In the example, a fixed valve actuation mechanism is shown, wherein the reaction force between the clamp assembly 400 and the valve actuation assembly 500 contributes to the full compression of the valve assembly 204. For example, as FIG. 6 As shown, with FIG. 5The clamp assembly 400 is actuated to secure the surgical cartridge 200 to the surgical console 100, and while securing the surgical cartridge to the surgical console 100, each hook 322 applies a force in the distal direction indicated by arrow 510, which pulls the surgical cartridge 200 against the surgical console 100. In response, each of the valve actuators 504, via a reaction force indicated by arrow 512, pushes further or more forcefully into the corresponding valve body 236, which further compresses the sealing material 250 within each orifice 230. The specific size and shape of the valve actuators 504 and the valve actuator shaft 502 will change the amount of reaction force 512 applied to the valve body 236. For example, the relative length of the valve actuator shaft 502, the length of the valve actuators 504, or the materials constituting the valve actuators 504 and the valve actuator shaft 502, as well as many other dimensions, will accordingly modify or change the reaction force 512. However, typically, the reaction force 512 provided by the valve actuation assembly 500 is greater than the opposite distal force 510 provided by the surgical cartridge 200 connected to the surgical console 100 via the clamp assembly 400.

[0053] In fact, FIG. 6 The fixed valve actuation mechanism shown applies the necessary force to compress the sealing material 250 only during the use of the surgical cartridge 200, rather than generating compressive force throughout the lifespan of the surgical cartridge 200, as the retaining ring 238 does. In some examples, because compression is applied only during the use of the surgical cartridge 200, the fixed valve actuation mechanism allows components of the valve assembly 204 to be made of different materials (including different plastic materials) that would otherwise have to withstand high reaction forces from the compressed valve assembly 204 throughout the lifespan of the surgical cartridge 200.

[0054] exist FIG. 7 The example illustrates a servo-driven valve actuation mechanism, wherein the reaction force between the clamp assembly 400 and the valve actuation assembly 500, combined with the force applied by the servo-driven valve actuation mechanism, promotes full compression of the valve assembly 204. As shown in the figure, FIG. 7Each valve actuation assembly 500 includes an actuator 524 that drives bidirectional lateral and / or axial movement of the valve actuation shaft 502 and / or valve actuation head 504. During operation, after the clamp assembly 400 has been actuated to secure the surgical cassette 200, each hook 322 applies a force in the distal direction indicated by arrow 510, thereby pulling the surgical cassette 200 against the surgical console 100. In addition to the reaction force caused by the clamp assembly 400 as discussed above, the actuator 524 coupled to the valve actuation assembly 500 can further actuate the valve actuation shaft 502 in the proximal or distal direction indicated by bidirectional arrow 516 to increase or decrease the compression of the valve assembly 204. For example, to increase the pressure applied by the actuation head 504 and further compress the sealing material 250, the actuator 524 actuates the valve actuation shaft 502 in the proximal direction, thereby applying a higher reaction force, as indicated by arrow 514. Alternatively, if a smaller pressure is desired from the valve drive head 504, the actuator 524 actuates the valve drive shaft 502 in the distal direction, which reduces or counteracts the reaction force generated in response to the actuation of the clamp assembly 400.

[0055] In some embodiments, the valve actuation assembly 500 engages the valve assemblies 204 after the clamp assembly 400 has pulled the surgical cartridge 200 against the surgical console 100. In this embodiment, the force applied by the valve actuation assembly 500 is therefore independent of the reaction force from the clamp assembly 400.

[0056] The actuator 524 within the valve actuation assembly 500 may include any suitable type of actuator or motor for driving the valve actuation shaft 502 and / or valve actuation head 504, such as a servo motor, electric motor, hydraulic motor, or piston, pneumatic motor, or any other means for providing axial movement. Because each valve actuation assembly 500 includes its own corresponding actuator 524, each valve actuation assembly 500 can be actuated independently of each other, thereby allowing the surgical console 100 to automatically increase or decrease the compression applied to a selected valve assembly 204 within the surgical cartridge 200. In some embodiments, each valve actuation assembly 500 further includes a force sensor 526 that detects and measures the mechanical load or physical stress on the valve actuation head 504, and thus detects and measures the contact and pressure between the valve actuation head 504 and / or the actuation interface 258 of the valve body 236. The signal from force sensor 526 can then be relayed to and / or used by driver 524 to initiate actuation of valve drive shaft 502 by a predetermined amount or distance to create a seal by compressing sealing material 250 by a desired amount. Using a servo-driven valve drive assembly 500 and force sensor 526, or other means for sensing contact with valve assembly 204, can provide additional capabilities beyond those described above. FIG. 7Additional benefits beyond those discussed. For example, the use of the actuator 524 (configured to apply a predetermined amount of force to the valve assembly 204 or to move the valve drive head 504 a predetermined distance) eliminates the influence of tolerances on the final compression of each valve assembly 204 and results in more consistent compression of the sealing material 250. Furthermore, according to some embodiments, individual valve assemblies 204 are compressed separately, which is advantageous for valve assemblies 204 with different geometries, torque requirements, etc.

[0057] exist FIG. 8 The example illustrates a plate-driven valve actuation mechanism, wherein the reaction force between the clamp assembly 400 and the valve actuation assembly 500, combined with the force applied by the plate-driven valve actuation mechanism, promotes full compression of the valve assembly 204. FIG. 8 Instead of coupling the actuator 524 to each valve actuation assembly 500, one or more actuators 524 are operatively coupled to a plate 518 of the fluid control subsystem 110, and the plate 518 is further coupled to each of the valve actuation assemblies 500. Accordingly, actuation of the plate 518 by the one or more actuators 524 provides the compressive force necessary to generate a sufficient seal within each valve assembly 204 disposed on the surgical cartridge 200. For example, after the clamp assembly 400 has been actuated to secure the surgical cartridge 200, each hook 322 applies a force in the distal direction indicated by arrow 510, thereby pulling the surgical cartridge 200 against the surgical console 100. In addition to the reaction force caused by the clamp assembly 400 as discussed above, the actuator 524 coupled to the plate 518 can simultaneously further actuate each of the valve drive shafts 502 by applying a proximal force distributed across the plate 518 as indicated by arrow 520 (e.g., along the height of the plate 518 and across the width of the plate), thereby increasing the pressure applied by each of the drive heads 504 and further compressing the sealing material 250. Alternatively, if a smaller pressure is desired from the valve drive head 504, the actuator 524 actuates the plate 518 in a distal direction, which can reduce or counteract the reaction force generated in response to the actuation of the clamp assembly 400.

[0058] In some embodiments, similar to FIG. 8Each valve actuation assembly 500 includes a force sensor 526 that detects contact between the valve actuation head 504 and a corresponding actuation interface 258 of the valve body 236 and measures the force between them. The force sensor then signals the actuator 524 to begin actuating the plate 518 by a predetermined amount or distance, thereby forming the desired compression of the sealing material 250. As the plate 518 is pushed proximally against each of the valve actuation assemblies 500, a proximally distributed force 520 is transmitted to each of the valve actuation heads 504, which in turn apply a proximally force, as indicated by arrow 522, to each corresponding valve body 236. The force 522 provided by the valve actuation head 504 pushes the valve body 236 into the surgical cartridge 200 and further compresses the sealing material 250, thereby creating a robust seal between the sealing material 250 and the rear surface of the surgical cartridge 200. In some embodiments, the fluid control subsystem 110 includes a plurality of plates 518, or each valve actuation assembly 500 includes a plate 518. Each of these multiple plates 518 can be actuated individually or in combination by one or more drivers 524 to selectively compress one, some, or all of the valve assemblies 204 disposed within the surgical cartridge 200 as needed.

[0059] like FIG. 8 As shown, because each of the valve actuation assemblies 500 is connected to the common plate 518, all valve actuation assemblies 500 will move together simultaneously, thereby applying the same amount of pressure to each of the valve assemblies 204 at the same time.

[0060] Accordingly, this document describes an apparatus and method of use for providing sufficient compression between a valve actuation assembly disposed within a surgical console and a valve assembly disposed within a surgical cartridge. The various embodiments provided herein reduce the amount of reaction force experienced by the valve assembly during the life of the surgical cartridge, thereby reducing wear and tear on the different components of the surgical cartridge and on the machines used during the manufacturing process. The lower reaction force on the valve assembly results in less valve compression required during production to compensate for losses of compression and compressive force over time. In some embodiments where the actuation mechanism adjusts the compression of the valve assembly after engagement, less valve compression is required during production to compensate for manufacturing tolerances and / or part tolerances. Additionally, less torque is required to rotate the valve body of the valve assembly. Furthermore, the chance of valve wear during rotation is reduced due to the lower compression. Moreover, because less reaction force is required, less stress is applied to the cartridge components, including the retaining ring, base, and joints within the surgical cartridge near the valve assembly. Therefore, the cartridge components can be formed without specialized ultrasonic welding equipment or the use of special materials typically required for higher strength thresholds or tolerances.

[0061] 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 system for attaching a surgical console to a surgical box during surgical procedures, the system comprising: At least one valve assembly is disposed within the surgical box; At least one valve actuation assembly is disposed within the surgical console, the at least one valve actuation assembly being configured to engage a valve body within the at least one valve assembly; as well as A clamping assembly disposed within the surgical console is configured to apply a distal force to the surgical cartridge. The at least one valve actuation assembly is further configured to apply a force to the at least one valve assembly in response to a distal force applied by the clamping assembly to compress a sealing material disposed on a first end of the valve body, and wherein the force provided by the at least one valve actuation assembly is greater than the distal force provided by the clamping assembly.

2. The system as claimed in claim 1, wherein, The at least one valve actuation component includes: Valve-driven motor; The valve drive shaft connected to the valve drive motor; and The valve drive head is connected to the valve drive shaft. The valve drive head is further configured to engage with a drive interface located on the second end of the valve body.

3. The system of claim 1, further comprising at least one actuator disposed within the surgical console, the at least one actuator being configured to apply a proximal force to the at least one valve actuation assembly.

4. The system of claim 3, further comprising a plate coupled to the at least one valve actuation assembly, wherein, The at least one driver is configured to apply the proximal force to the plate.

5. The system as described in claim 3, wherein, The driver includes at least one of a servo motor, a hydraulic motor, or a pneumatic motor.

6. A method for a surgical console to provide a proximal force to a surgical cassette during ophthalmic surgery, the method comprising: Connect the surgical box to the surgical console; Connect the valve drive assembly in the surgical console to the valve assembly in the surgical box; A force is applied from the valve actuation assembly to the valve body within the valve assembly; and The sealing material is compressed at the first end of the valve body, wherein the force provided by the valve actuation assembly is greater than the opposing force provided by the surgical cartridge connected to the surgical console via the clamp assembly.

7. The method of claim 6, wherein, Connecting the valve actuation assembly within the surgical console to the valve assembly within the surgical box includes: Align the valve actuation head, located at the proximal end of the valve actuation assembly, with the valve body; and Insert the valve drive head into the drive interface located on the second end of the valve body.

8. The method of claim 6, wherein, Connecting the surgical box to the surgical console includes applying a distal force from the surgical box to the surgical console.

9. The method of claim 8, wherein, Applying a force from the valve actuation assembly to the valve body within the valve assembly includes applying a reaction force in response to a distal force from the surgical cartridge to the surgical console.

10. The method of claim 6, wherein, Applying a force from the valve actuation assembly to the valve body within the valve assembly includes actuating the valve actuation assembly in a proximal direction.

11. The method of claim 10, wherein, Actuating the valve actuation assembly in the proximal direction includes actuating a plate coupled to the valve actuation assembly in the proximal direction.

12. The method of claim 10, wherein, Actuating the valve drive assembly in the proximal direction includes actuating at least one of a servo motor, a hydraulic motor, or a pneumatic motor connected to the valve drive assembly.

13. The method of claim 6, further comprising: Connect the multiple valve drive components in the surgical console to the corresponding multiple valve components in the surgical box; as well as Force is applied from each of the plurality of valve actuation assemblies to the valve body within each of the plurality of valve assemblies.

14. The method of claim 13, wherein, Applying force from each of the plurality of valve actuation assemblies to the valve body within each of the plurality of valve actuation assemblies comprises: independently actuating each of the plurality of valve actuation assemblies in the proximal direction via an actuator coupled to each of the plurality of valve actuation assemblies.

15. The method of claim 13, wherein, Applying force from each of the plurality of valve actuation assemblies to the valve body within each of the plurality of valve assemblies includes simultaneously actuating each of the plurality of valve actuation assemblies in the proximal direction via a plate coupled to each of the plurality of valve actuation assemblies.

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