Patent Description:
The present invention is generally related to a system for controlling surgical fluid flows, particularly during treatment of an eye.

The optical elements of the eye include both a cornea (at the front of the eye) and a lens within the eye. The lens and cornea work together to focus light onto the retina at the back of the eye. The lens also changes in shape, adjusting the focus of the eye to vary between viewing near objects and far objects. The lens is found just behind the pupil, and within a capsular bag. This capsular bag is a thin, relatively delicate structure which separates the eye into anterior and posterior chambers.

With age, clouding of the lens or cataracts are fairly common. Cataracts may form in the hard central nucleus of the lens, in the softer peripheral cortical portion of the lens, or at the back of the lens near the capsular bag.

Cataracts can be treated by the replacement of the cloudy lens with an artificial lens. Phacoemulsification systems often use ultrasound energy to fragment the lens and aspirate the lens material from within the capsular bag. This may allow the capsular bag to be used for positioning of the artificial lens, and maintains the separation between the anterior portion of the eye and the vitreous humour in the posterior chamber of the eye.

During cataract surgery and other therapies of the eye, accurate control over the volume of fluid within the eye is highly beneficial. For example, while ultrasound energy breaks up the lens and allows it to be drawn into a treatment probe with an aspiration flow, a corresponding irrigation flow may be introduced into the eye so that the total volume of fluid in the eye does not change excessively. If the total volume of fluid in the eye is allowed to get too low at any time during the procedure, the eye may collapse and cause significant tissue damage. Similarly, excessive pressure within the eye may strain and injure tissues of the eye.

While a variety of specific fluid transport mechanisms have been used in phacoemulsification and other treatment systems for the eyes, aspiration flow systems can generally be classified in two categories: <NUM>) volumetric-based aspiration flow systems using positive displacement pumps; and <NUM>) vacuum-based aspiration systems using a vacuum source, typically applied to the aspiration flow through an air-liquid interface. These two categories of aspiration flow systems each have unique characteristics that render one more suitable for some procedures than the other, and vice versa.

Among positive displacement aspiration systems, peristaltic pumps (which use rotating rollers that press against a flexible tubing to induce flow) are commonly employed. Such pumps provide accurate control over the flow volume. The pressure of the flow, however, is less accurately controlled and the variations in vacuum may result in the feel or traction of the handpiece varying during a procedure. Peristaltic and other displacement pump systems may also be somewhat slow.

Vacuum-based aspiration systems provide accurate control over the fluid pressure within the eye, particularly when combined with gravity-fed irrigation systems. While vacuum-based systems can result in excessive fluid flows in some circumstances, they provide advantages, for example, when removing a relatively large quantity of the viscous vitreous humour from the posterior chamber of the eye. However, Venturi pumps and other vacuum-based aspiration flow systems are subject to pressure surges during occlusion of the treatment probe, and such pressure surges may decrease the surgeon's control over the eye treatment procedure.

Different tissues may be aspirated from the anterior chamber of the eye with the two different types of aspiration flow. For example, vacuum-induced aspiration flow may quickly aspirate tissues at a significant distance from a delicate structure of the eye (such as the capsular bag), while tissues that are closer to the capsular bag are aspirated more methodically using displacement-induced or positive-displacement flows.

Conventionally, fluid aspiration systems include a console and a fluidic cassette mounted on the console. The fluidic cassette is typically changed for each patient and cooperates with the console to provide fluid aspiration. Generally, a single type of cassette is used by a particular console, regardless of whether the procedure will require positive displacement aspiration, vacuum-based aspiration, or both. Examples of cassettes currently used in the marketplace may be found in <CIT>, <CIT>, and <CIT>. <CIT> and <CIT>, provide examples of cassettes.

A fluidic cassette may include means for controlling fluid flow through the cassette. In various embodiments, a fluidic cassette may include a gasket or flexible membrane located within the cassette that is configured to direct fluid flow in a predetermined flow path through the cassette. The gasket may be surrounded by front and back plates that form the body of the cassette, and the gasket may include one or more valves or a sensor that are accessible through the back plate. The surgical cassette may further include one or more tube retainers configured and dimensioned to guide a portion of either an irrigation or aspiration tube into a desired shape. The desired shape may be capable of being used with a peristaltic pump to pump fluid through the pathways formed by the gasket.

A gasket of a fluidic cassette may have a body, wherein the body is deformable and has a front surface and a back surface. The front surface may have one or more raised contours that create one or more channels that are configured and dimensioned to control fluid flow through one or more corresponding channels of a surgical cassette. The back surface may have one or more elevated portions that correspond to the one or more channels of the front surface and act as a valve. The gasket may also have a deformable membrane having an annular surface capable of coupling with a transducer of a surgical console. The console may include one or more solenoid devices that engage with the back surface of the gasket through the back plate of the cassette, thereby operating or controlling the valve of the gasket to control fluid flow in the flow pathway.

In light of the above, it would be advantageous to provide improved devices, systems, and methods for eye surgery, and more particularly for the control of fluid flow through a fluidic cassette during eye surgery.

<CIT> describes a cassette for use in combination with a surgical instrument and a control console for controlling the flow rates of irrigation and/or aspiration liquid in the instrument.

<CIT> describes an extracorporeal blood perfusion system which includes a disposable assembly and a control unit having a control interface region.

<CIT> describes a phacoemulsification surgical console, and a related system. <CIT> describes an eye treatment system, having a cassette and a console. The system comprises a selector valve making use of a resilient valve conduit in the cassette that is engaged by an actuator on the console.

The present invention claims a surgical system according to claim <NUM>. Optional features are mentioned in the dependent claims <NUM>-<NUM>.

The present invention provides a surgical cassette manifold, having a front housing, a rear housing, and a gasket, wherein the front housing comprises one or more molded fluid channels and one or more seal channels, herein the gasket is coupled with the rear housing and at least a portion of the gasket is located between the front housing and the rear housing, and wherein the gasket has one or more seal lips configured and dimensioned to couple with the one or more seal channels to form one or more fluid flow channels through the cassette. The gasket comprises one or more valves controllable through the rear housing, the valves configured to extend into the one or more fluid flow channels to reduce or block fluid flow through the flow channels.

The present invention provides a surgical cassette manifold configured to be coupled to a surgical console, the cassette manifold having a front housing, a rear housing, and a flexible gasket, wherein the gasket comprises one or more flexible flow restriction valves that reduce or block fluid flow through flow channels in the cassette, the flow restriction valves positioned along either a first flow path of irrigation fluid flowing through the cassette to a surgical handpiece or a second flow path of aspirated fluid from the surgical handpiece flowing through the cassette, or both. The flow restriction valves are actuated to reduce or block fluid flow through the first or second flow paths via one or more actuation plungers located on the surgical console. In various embodiments, the plungers may be actuated by a solenoid or other similar means to apply pressure to the flexible valves to deform the flexible valves into the flow paths.

The present invention provides a surgical cassette manifold configured to be coupled to a surgical console, the cassette manifold including a flexible gasket comprising one or more valves that reduce or block fluid flow through the surgical cassette, wherein the one or move valves are positioned adjacent a first flow path of fluid flowing into a surgical handpiece from the cassette and a second flow path of fluid flowing through the cassette that has been aspirated from the surgical handpiece. The one or more valves are actuated by an actuation plunger of the surgical console, which may be electronically controlled by a controller of the console. In various embodiments, the plungers may be actuated by a solenoid or other similar means to apply pressure to the flexible valves to deform the flexible valves into the flow paths.

In illustrative embodiments, one or more flexible valves of a surgical cassette and one or more actuation plungers of a surgical console include a positioning feature configured to assist with positioning the one or more actuation plungers to apply uniform and symmetric pressure to the one or more valves. The positioning feature includes at least two features: (i) a locking recess on a back surface of the one or more valves, the locking recess formed between two spaced-apart teeth or protrusions that extend axially away from (and are generally perpendicular to) the valve surface; and (ii) a blade tooth that extends axially away from an end surface of the plunger and is configured to be received with the locking recess to engage the valve. The positioning feature ensures the plunger is properly aligned with the flexible valve as the valve is deformed inward under pressure from the plunger.

In the present invention, a positioning feature of the surgical cassette and a surgical console include i) a locking recess on a back surface of the one or more valves, the locking recess may be formed between two spaced-apart teeth or protrusions that extend axially away from (and are generally perpendicular to) the valve surface; and (ii) a blade tooth that may extend axially away from an end surface of the plunger and is configured to be received with the locking recess to engage the valve. The locking recess formed by the teeth and blade tooth may be configured to be of complimentary shapes and sizes so that the blade tooth abuts against the surface of the teeth when the blade tooth is received with the locking recess. In various embodiments, a surface of the teeth may be concave in nature and a surface of the blade tooth may be convex in nature. In alternative embodiments, the positioning feature may further include an end cap on the blade tooth, the end cap include angled surfaces that correspond with tapered surfaces that further define the locking recess of the valve.

The present invention is best understood with reference to the following detailed description of the invention and the drawings in which:.

Reference will now be made in detail to embodiments of the invention, examples of which are illustrated in the accompanying drawings. While the invention will be described in conjunction with the embodiments, it will be understood that they are not intended to limit the invention to those embodiments. On the contrary, the invention is intended to cover alternatives, modifications, which are within the scope of the invention as defined by the appended claims.

Referring to <FIG>, a system <NUM> for treating an eye E of a patient P generally includes an eye treatment probe handpiece <NUM> coupled to a console <NUM> by a cassette <NUM> mounted on the console. Handpiece <NUM> may include a handle for manually manipulating and supporting an insertable probe tip. The probe tip has a distal end which is insertable into the eye, with one or more lumens in the probe tip allowing irrigation fluid to flow from the console <NUM> and/or cassette <NUM> into the eye. Aspiration fluid may also be withdrawn through a lumen of the probe tip, with the console <NUM> and cassette <NUM> generally including a vacuum aspiration source, a positive displacement aspiration pump, or both to help withdraw and control a flow of surgical fluids into and out of eye E. As the surgical fluids may include biological materials that should not be transferred between patients, cassette <NUM> will often comprise a disposable (or alternatively, resterilizable) structure, with the surgical fluids being transmitted through conduits of the cassette that avoid direct contact in between those fluids and the components of console <NUM>.

When a distal end of the probe tip of handpiece <NUM> is inserted into an eye E, for example, for removal of a lens of a patient with cataracts, an electrical conductor and/or pneumatic line (not shown) may supply energy from console <NUM> to an ultrasound transmitter of the handpiece, a cutter mechanism, or the like. Alternatively, the handpiece <NUM> may be configured as an irrigation/aspiration (I/A) or vitrectomy handpiece. Also, the ultrasonic transmitter may be replaced by other means for emulsifying a lens, such as a high energy laser beam. The ultrasound energy from handpiece <NUM> helps to fragment the tissue of the lens, which can then be drawn into a port of the tip by aspiration flow. So as to balance the volume of material removed by the aspiration flow, an irrigation flow through handpiece <NUM> (or a separate probe structure) may also be provided, with both the aspiration and irrigations flows being controlled by console <NUM>.

So as to avoid cross-contamination between patients and/or to avoid incurring excessive expenditures for each procedure, cassette <NUM> and its conduit <NUM> may be disposable. Alternatively, the conduit or tubing may be disposable, with the cassette body and/or other structures of the cassette being sterilizable. Regardless, the disposable components of the cassette are typically configured for use with a single patient, and may not be suitable for sterilization. The cassette will interface with reusable (and often quite expensive) components of console <NUM>, which may include one or more peristaltic pump rollers, a Venturi or other vacuum source, a controller <NUM>, and the like.

Controller <NUM> may include an embedded microcontroller and/or many of the components common to a personal computer, such as a processor, data bus, a memory, input and/or output devices (including a touch screen user interface <NUM>), and the like. Controller <NUM> will often include both hardware and software, with the software typically comprising machine readable code or programming instructions for implementing one, some, or all of the methods described herein. The code may be embodied by a tangible media such as a memory, a magnetic recording media, an optical recording media, or the like. Controller <NUM> may have (or be coupled to) a recording media reader, or the code may be transmitted to controller <NUM> by a network connection such as an internet, an intranet, an Ethernet, a wireless network, or the like. Along with programming code, controller <NUM> may include stored data for implementing the methods described herein, and may generate and/or store data that records parameters corresponding to the treatment of one or more patients. Many components of console <NUM> may be found in or modified from known commercial phacoemulsification systems from Abbott Medical Optics Inc. of Santa Ana, California; Alcon Manufacturing, Ltd. Worth, Texas; Bausch and Lomb of Rochester, New York; and other suppliers.

In illustrative embodiments, a surgical cassette manifold <NUM> is configured to be coupled and removed from the console <NUM> after use during a surgical procedure. <FIG> and <FIG> illustrate a surgical cassette manifold <NUM> of the present invention, including components of the surgical cassette manifold <NUM>. Cassette or surgical cassette <NUM> is an assembled surgical cassette manifold <NUM> having fluid pathways and connected tubing configured to manage one or more of the following: fluid inflow, fluid outflow, fluid vacuum level, and fluid pressure in a patient's eye E when the cassette <NUM> is coupled with console <NUM>.

As shown in <FIG> and <FIG>, the surgical cassette manifold <NUM> has a front housing <NUM>, a rear housing <NUM>, a first tubing <NUM>, and a second tubing <NUM>. Rear housing <NUM> may also have a gasket <NUM> co-molded or over-molded with rear housing <NUM>. As illustrated in <FIG> and <FIG>, the rear housing <NUM>, the front housing <NUM>, or a combination of both may have axial mating plane surfaces <NUM>. Axial mating plane surfaces <NUM> are outer border faces of the back housing <NUM> and/or front housing <NUM> that form a surface mating with console <NUM> within a cassette receiver <NUM> of the console <NUM> after loading.

<FIG> illustrate the front housing <NUM> in more detail. <FIG> shows a perspective view of an illustrative embodiment of a front surface <NUM> of front housing <NUM>, the front surface <NUM> including a handle <NUM> (e.g. finger grip handle), a drain port <NUM>, and an attachment clip <NUM>. A drain bag <NUM>, as seen in <FIG>, may be attached to the front surface <NUM> of front housing <NUM> via the drain port <NUM> and attachment clip <NUM> such that, when the surgical cassette <NUM> is coupled with the console <NUM> and fluid is aspirated from an eye E of a patient P, the fluid is capable of being collected in the drainage bag <NUM> via the drain port <NUM>. The drain bag <NUM> may be supported on surgical cassette manifold <NUM> by the attachment clip <NUM> and/or drain port <NUM>. <FIG> shows a perspective view of a back surface <NUM> of the front housing <NUM>, the back surface <NUM> having in illustrative embodiments one or more molded fluid channels <NUM>, a reservoir <NUM>, a first pump ramp or profile <NUM> configured and dimensioned for mating with a peristaltic pump, and an optional second pump ramp or profile <NUM> configured and dimensioned for mating with a peristaltic pump.

<FIG> and <FIG> illustrate the rear housing <NUM> in more detail. <FIG> is a front perspective view of the rear housing <NUM> and <FIG> is a back perspective view of rear housing <NUM>. In illustrative embodiments, rear housing <NUM> includes a front surface <NUM> and a back surface <NUM>. The rear housing <NUM> may include a reservoir <NUM>, upper tube connections <NUM>, optional lower tube connections <NUM>, and one or more tubing retainer clips <NUM>. In an embodiment, upper tube connections <NUM> are located between the front surface <NUM> and back surface <NUM> and have a slight taper from bottom toward the top so that the tubing stays on the upper tube connections <NUM>, as illustrated in <FIG>. Lower tube connection <NUM> may similarly be located between front surface <NUM> and back surface <NUM> and have a tapered head to secure second tubing <NUM> to lower tube connections <NUM>. As shown in <FIG>, rear housing <NUM> may include the gasket <NUM> co-molded or over-molded to it. Rear housing <NUM> is configured to be coupled together (for example, in a snap fit engagement) with front housing <NUM> to contain gasket <NUM> there between.

In illustrative embodiments, the surgical cassette <NUM> may include at least one peristaltic pump tube <NUM>. <FIG> and <FIG> show the backside of surgical cassette <NUM> and a peristaltic pump tube <NUM>. In an embodiment, pump tube <NUM> may have a first end and a second end that couple with upper tube connections <NUM>. The peristaltic pump tube <NUM> may be an elastomeric length of tubing that is configured to generate positive displacement of fluid flow in the direction of a pump roller (not shown) of the console <NUM> when a portion of the peristaltic pump tube <NUM> is compressed between the peristaltic pump rollers of console <NUM> and the ramp <NUM> of the front housing <NUM> of surgical cassette <NUM>. It is also envisioned that any type of flow-based pump and corresponding components may be used with surgical cassette <NUM>. In an embodiment, the ramp <NUM> may include a backing plate pump profile <NUM> comprised of contoured surfaces formed on the inside of the front housing <NUM> of cassette <NUM> to provide moving compression on the tubing <NUM> while creating peristaltic pumping flow through the cassette <NUM>, particularly through pump tube <NUM>. In various embodiments, pump tube <NUM> may be formed to partially conform to the shape of ramp <NUM>, as illustrated, for example, in <FIG>.

In illustrative embodiments, the surgical cassette <NUM> may optionally include a second peristaltic pump tube <NUM>, as illustrated in <FIG> and <FIG>. The second pump tube <NUM> may be configured of similar size and shape as first pump tube <NUM>. In an embodiment, second pump tube <NUM> may have a first end and a second end that couple with lower tube connections <NUM>. Once surgical cassette manifold <NUM> is assembled, second tubing <NUM> and ramp <NUM> are configured to couple with a peristaltic rollers (not shown) located on console <NUM> to create a peristaltic pump. In an embodiment, lower tube connections <NUM> are on the same axis, i.e. there is axial alignment of the inflow and outflow of the second tubing <NUM>, and maintain a specific distance apart resulting in a more accurate peristaltic pump due to a controlled length of the second tubing <NUM>, which provides a consistent flow rate and a consistent interface with ramp <NUM> and peristaltic rollers. Moreover, such aligned and consistent interfaces results in less noise/sound generated by the peristaltic pump during operation. Such axial alignment may also be provided between upper tube connections <NUM> and first pump tube <NUM>.

During assembly, rear housing <NUM> is mated with front housing <NUM>, first tube <NUM> is configured to conform with first pump ramp <NUM>, and second tube <NUM> is configured to conform with second pump ramp <NUM>. First pump ramp <NUM> is configured and dimensioned for mating with a first peristaltic pump (not shown) located within the console <NUM>. Second tube <NUM> is configured to conform with second pump ramp <NUM>. Second pump ramp <NUM> is configured and dimensioned for mating with a second peristaltic pump (not shown) located within the console <NUM>. Reservoir <NUM> of front housing <NUM> and reservoir <NUM> of rear housing <NUM> are configured to be generally aligned to create a void <NUM> within cassette manifold <NUM> defined by reservoir <NUM> and reservoir <NUM>, as illustrated for example in <FIG>. Void <NUM> is configured to retain fluid pumped into cassette <NUM> from the handpiece <NUM> by the first peristaltic pump. The fluid retained in void <NUM> by reservoirs <NUM> and <NUM> may then be pumped out of cassette <NUM> to drain port <NUM> by the second peristaltic pump.

In illustrative embodiments, reservoir <NUM> may have a sump <NUM>. Sump <NUM> is a portion of reservoir <NUM> that extends below a bottom 120c of reservoir <NUM> that promotes fluid to flow from the reservoir <NUM> to sump <NUM> and to the lower tube connection <NUM>. Sump <NUM> may (<NUM>) reduce turbulence of the tank; and (<NUM>) ensure a drain inlet port 133a of the lower tube connection <NUM> is always below the level of fluid inside the void <NUM>, therefore fluid is consistently pumped out of the cassette <NUM> and not air (which may cause the drain bag <NUM> to balloon).

In illustrative embodiments, tubing retainer clips <NUM> (shown in <FIG> and <FIG>) may be provided to protrude substantially perpendicularly from a plane of the back side <NUM> of front housing <NUM> to secure the first pump tube <NUM>. Tubing retainer clips <NUM> are configured and dimensioned to assist with easy assembly of surgical cassette manifold <NUM> and maintaining first tubing <NUM> in a specific orientation after assembly. Similar tubing retainer clips <NUM> may be positioned to retain second pump tube <NUM>.

In illustrative embodiments, gasket <NUM> may be over-molded with back housing <NUM> such that gasket <NUM> is secured to back housing <NUM>, and gasket <NUM> is further configured to be sandwiched between front housing <NUM> and back housing <NUM> when the cassette <NUM> is assembled together. As shown in <FIG>, front housing <NUM> also may have one or more seal channels <NUM>. Seal channels <NUM> may be configured and dimensioned to mate with gasket <NUM>. Specifically, seal channels <NUM> may be configured and dimensioned to mate with a seal lip <NUM> that extends outwardly or perpendicularly from a front surface <NUM> of gasket <NUM>. Seal lip <NUM> is a part of gasket <NUM> configured to create a seal or lid over molded fluid channels <NUM> of front housing <NUM>. The seal lip <NUM> may have any dimension suitable for mating with seal channel <NUM>. In an embodiment, seal lip <NUM> may be tapered, starting thicker at its proximal end and becoming thinner towards its distal end. In another embodiment, seal lip <NUM> may be slightly larger than seal channel <NUM> to create a snug fit. Seal lip <NUM> provides positioning alignment on front housing <NUM> and rear housing <NUM>.

Gasket <NUM> may be formed separately from rear housing <NUM> and then co-molded or over-molded onto rear housing <NUM>. Gasket <NUM> includes a front surface <NUM> and a back surface <NUM> such that the front surface <NUM> is adjacent the front housing <NUM> and the back surface <NUM> is adjacent the rear housing <NUM> when the front housing <NUM> is coupled to the rear housing <NUM>. The front surface <NUM> of gasket <NUM> includes the seal lip <NUM> which extends away or protrudes in a substantially perpendicular direction from a plane of gasket <NUM> and rear housing <NUM>, as illustrated in <FIG> and <FIG>. Gasket <NUM> may include a pressure/vacuum sensor diaphragm <NUM>, an aspiration vent valve <NUM>, and/or an irrigation valve <NUM>, discussed in more detail below.

In an embodiment, gasket <NUM> may be molded, co-mold, or two-shot molded onto or with rear housing <NUM>. Molding gasket <NUM> onto rear housing <NUM> in such a manner reduces or eliminates a leak path which is possible with molded fluid channels when using two different materials. In an embodiment, a method of eliminating leaking of molded fluid channels by combining two different materials for creating a proper seal is envisioned resulting in an easier manufacturing method by creating a self-aligning gasket <NUM>. In an alternative embodiment, when assembling rear housing <NUM> to front housing <NUM>, mating of seal lip <NUM> and seal channel <NUM> can be achieved using a plurality of alignment pins <NUM> on rear housing <NUM> that mate with counterpart pin holes <NUM> on front housing <NUM>, as illustrated in <FIG> and <FIG>. Using alignment pins <NUM> and pin holes <NUM> as opposed to relying only on the flexible seal lip <NUM> and seal channel <NUM> allows for an easier and more efficient assembly process. Molding gasket <NUM> onto or with rear housing <NUM> results in pre-alignment/pre-keyed/pre-orientation of seal lip <NUM> for properly sealing with molded fluid channels <NUM> on front housing <NUM>, thus reducing or even eliminating leaking and increasing ease of manufacture.

In illustrative embodiments, when gasket <NUM> is properly placed between front housing <NUM> and rear housing <NUM>, and front and rear housings <NUM> and <NUM> are coupled together, molded fluid channels <NUM> of front housing <NUM> and portions of the gasket <NUM> between the seal lips <NUM> form at least one sealed flow channel or pathway <NUM> through the cassette <NUM>. Referring to <FIG> and <FIG>, sealed flow channel <NUM> includes one or more fluid flow pathways formed by raised surfaces (e.g. seal channels <NUM> of front housing <NUM>) allowing fluid to flow in internal channels between the raised surfaces and outer perimeter sealing (e.g. seal lips <NUM>) border of gasket <NUM> to retain fluid within the manifold fluid flow channels <NUM> under positive pressure and vacuum conditions. Accordingly, the sealed flow channel <NUM> directs the flow of fluids through the cassette manifold <NUM> as the peristaltic pumps operate. Sealed flow channel <NUM> is generally in fluid communication with fluid reservoir <NUM>. The sealed flow channel <NUM>, comprising of the molded fluid channels <NUM> and gasket <NUM>, accordingly eliminates the need for tubing to transport fluid through the cassette <NUM>.

In various embodiments, sealed flow channel <NUM> may include an irrigation flow channel 150a and an aspiration flow channel 150b. Irrigation flow channel 150a is configured as a pathway with an inlet tubing port (not shown) from a balance salt solution (BSS) irrigation bottle (not shown) metered by one or more irrigation valves to one or more of the following: (<NUM>) an irrigation tubing outlet port (not shown) connected to an external surgical handpiece <NUM> flowing fluid to the eye, which may be metered or controlled by irrigation valve <NUM>; or (<NUM>) a venting line (not shown) providing BSS irrigation fluid into the aspiration flow channel 150b. In various embodiments, irrigation flow channel 150a may be positioned within cassette <NUM> to transport fluid that is driven into the cassette <NUM> from a gravity-driven irrigation bottle, through the cassette <NUM>, and to the external handpiece <NUM> to provide irrigation fluid to the surgical field. In illustrative embodiments, fluid may be transported into the cassette <NUM> via an irrigation tube <NUM>, as illustrated in <FIG>. Other means of flow for irrigation fluid through a cassette and to a handpiece <NUM> are known in the art.

Aspiration flow channel 150b is configured as a pathway for fluid to flow from the external handpiece <NUM> to the drainage port <NUM> after the fluid or other particles have been aspirated from a patient's eye E. In illustrative embodiments, during aspiration of a patient's eye E, fluid flows through the aspiration flow channel 150b in various manners. For instance, fluid may flow into the first pump tube <NUM> via a pump tube inlet 137a. Upper tube connections <NUM> of rear housing <NUM> may comprise pump tube inlet 137a and pump tube outlet 137b to transport fluid from pump tube inlet 137a, through the first pump tube <NUM>, and then through the pump tube outlet 137b as the first peristatic pump operates. In illustrative embodiments, aspiration flow channel 150b extends from pump tube outlet 137b to transport fluid through the cassette manifold <NUM>. Aspiration flow channel <NUM> extends from pump tube outlet 137b to reservoir <NUM> along a first pathway <NUM>, as illustrated in <FIG> and <FIG>. Fluid is therefore transported into reservoir <NUM> via first pathway <NUM>. Fluid may be transported out of reservoir <NUM> via a drain pump inlet port 133a. Lower tube connections <NUM> may comprise drain pump inlet port 133a and a drain pump outlet 133b to transport fluid from drain pump inlet port 133a, through the second pump tube <NUM>, and then through the drain pump outlet port 133b as the second peristatic pump operates. Drain pump outlet 133b is coupled with a drain bag <NUM> to allow fluid to be removed from reservoir <NUM> via the second peristaltic pump, as illustrated in <FIG> and <FIG>. Illustratively, a second pathway <NUM> of flow channel <NUM> runs in a vertical direction from a lower tube connection <NUM> (that is fluidly connected to the second tubing <NUM> associated with a second peristaltic pump) to drain port <NUM> out to the drain bag <NUM>. Other configurations of an aspiration flow channel 150b are envisioned within the scope of this disclosure.

The aspiration flow channel 150b may further include a venting port for venting fluid inflow from a BSS irrigation bottle or the irrigation flow channel 150a, which may be metered into the aspiration flow channel 150b by the aspiration vent valve <NUM>. Aspiration vent valve <NUM> is configured to permit introduction of irrigation fluid into the aspiration flow channel 150b, which may be metered by vent valve <NUM>, to, for example, reduce vacuum level in the aspiration flow channel 150b. Such reduction of vacuum level may be necessary following obstruction or occlusion of the tip of handpiece <NUM> by, for example, particles being aspirated from the eye E.

In illustrative embodiments, to monitor and control the flow of fluid through the sealed flow channel <NUM>, the cassette <NUM> may include a pressure/vacuum sensor diaphragm <NUM>, a aspiration vent valve <NUM>, and/or an irrigation valve <NUM>, as illustrated in <FIG>. Specifically, the pressure/vacuum sensor diaphragm <NUM>, aspiration vent valve <NUM>, and/or irrigation valve <NUM> may be formed within the gasket <NUM>. The gasket <NUM> adjacent the aspiration flow channel 150b may include the vacuum/pressure sensor diaphragm <NUM> and aspiration vent valve <NUM>, and the gasket <NUM> adjacent the irrigation flow channel 150a may include the irrigation valve <NUM>.

In illustrative embodiments, vacuum/pressure sensor diaphragm <NUM> may be a sealed flexible annular membrane with a central magnetic coupling disk <NUM>. The vacuum/pressure sensor diaphragm <NUM> may be positioned to be in fluid connection with the aspiration flow channel 150b. The central magnetic coupling disk <NUM> deforms: (<NUM>) proportionally outwards under fluid pressure conditions in the aspiration flow channel 150b, compressing a magnetically-coupled force displacement transducer <NUM> of console <NUM> (as illustrated in <FIG>); and (<FIG>) proportionally inwards under fluid vacuum conditions in the aspiration flow channel 150b, extending a magnetically-coupled force displacement transducer <NUM> of console <NUM>. Such deformation of the vacuum/pressure sensor diaphragm <NUM> allows for non-fluid contact measurement of fluid vacuum levels of the aspiration flow channel 150b of surgical cassette manifold <NUM>.

Referring to <FIG> and <FIG>, irrigation valve <NUM> of surgical cassette <NUM>, which in an embodiment may have a dome-like shape, may be an elastomeric deformable surface which allows irrigation flow from a BSS bottle to external surgical handpiece <NUM> when uncompressed and shuts off flow in the irrigation flow channel 150a when the irrigation valve <NUM> deforms into the irrigation flow channel 150a (towards the front housing <NUM>). Similarly, aspiration vent valve <NUM>, which in an embodiment may have a dome-like shape, may be an elastomeric deformable surface which allows irrigation flow (from the BSS bottle or irrigation flow channel 150a) into the aspiration flow channel 150b that is coupled with the external surgical handpiece <NUM>. When irrigation fluid is introduced into the aspiration flow channel 150b, the vacuum level of the aspiration flow channel 150b, and accordingly the vacuum level of aspiration occuring in the patient's eye E, is reduced. In various embodiments, the reduction could be such that aspiration flow is shut off when the aspiration vent valve <NUM> is deformed into fluid channels <NUM> (towards the front housing <NUM>). Accordingly, the level of fluid flow in the sealed fluid flow channel <NUM> may be controlled based upon the level of compression of valves <NUM> and <NUM> - from full flow to intermediate flow to no flow.

In an illustrative embodiment, as illustrated in <FIG>, surgical cassette <NUM> may have one or more valve control surfaces <NUM>. Valve control surfaces <NUM> may be a raised sealing surface in manifold fluid flow channels <NUM> of front housing <NUM> that provide a point of contact for valve <NUM> or <NUM> when they are deformed or activated toward the fluid flow channels <NUM> of front housing <NUM>.

The interaction between the console <NUM> and cassette <NUM> will now be described. In illustrative embodiments, a fluidics module <NUM> according to an embodiment of the present invention comprises an assembly of components mounted to the console <NUM> for interfacing with the surgical cassette <NUM>, as illustrated in <FIG>. A fluidics module <NUM> may have one or more of the following components: (i) a cassette receiver <NUM>, (ii) a cassette pre-load detection pin, and/or (iii) a pre-load detection switch. For instance, a cassette receiver <NUM> may be a section of fluidics module <NUM> defining an engagement area for loading and aligning surgical cassette <NUM> in its intended position relative to various components of fluidics module <NUM>. In other embodiments, fluidics module <NUM> may have one or more pump roller assemblies (not shown) configured with multiple roller elements in a circular or substantially circular pattern which produce peristaltic flow-based fluid transport when rotated against compressed fluid-filled peristaltic pump tubes <NUM> and <NUM>. Other components of a fluidics module are generally known in the art and may be incorporated into the fluidics module <NUM> of the present disclosure to assist with interfacing the surgical cassette <NUM> with the console <NUM>.

In illustrative embodiments, fluidics module <NUM> may have a force displacement transducer <NUM>. Force displacement transducer <NUM> may be electrically or otherwise connected with the controller <NUM>. Force displacement transducer <NUM> may operate by means of a magnetic coupling (via, for example, a magnet <NUM>) with the central magnetic coupling disk <NUM> of the vacuum/pressure sensor diaphragm <NUM>. Specifically, a vacuum occurrence of fluid inside the aspiration flow channel 150b formed by manifold fluid flow channels <NUM> will cause deformation inwards of the vacuum/pressure sensor diaphragm <NUM> (and the magnetic coupling disk <NUM>) in the surgical cassette <NUM>, and the magnetic force from the coupling disk <NUM> upon the magnet <NUM> of the force displacement transducer <NUM> will axially extend force displacement transducer <NUM> outward away from the fluidics module <NUM>, resulting in a change of an electrical output signal to the controller <NUM> in proportion to a vacuum level. Conversely, positive fluid pressure in the aspiration flow channel 150a formed by manifold fluid flow channels <NUM> results in an outward extension of vacuum/pressure sensor diaphragm <NUM> and compression of the force displacement transducer <NUM> inward toward the fluidics module <NUM>.

In an embodiment, fluidics module <NUM> may have an irrigation valve plunger <NUM> and an aspiration vent valve plunger <NUM>. Irrigation valve plunger <NUM> axially extends away from the fluidics module <NUM> and is controlled (e.g. by a solenoid (not shown) in the console <NUM>) to move in a direction towards or away from the fluidics module <NUM> when controlled by the controller <NUM>. The irrigation valve plunger <NUM> is configured to compress the irrigation valve <NUM> of surgical cassette <NUM>, resulting in a decrease or shutoff of irrigation flow in the irrigation flow channel 150a to external irrigation tubing line to the handpiece <NUM>. Irrigation valve plunger <NUM> may also operate by a spring-loaded retraction of the plunger to allow varying levels of irrigation flow. Similarly, vent valve plunger <NUM> may be controlled by controller <NUM> and have an axial extension of the plunger <NUM> that compresses aspiration vent valve <NUM> of surgical cassette <NUM>, resulting in a decrease or shutoff of irrigation venting flow to the aspiration flow channel 150b. Aspiration vent valve plunger <NUM> may also operate by a spring-loaded retraction of the plunger to allow irrigation pressure fluid flow to vent in aspiration flow channel 150b if the pressure/vacuum level requires reduction.

The irrigation valve plunger <NUM> and aspiration vent plunger <NUM> are configured with an end surface <NUM> and <NUM>, respectively, that are configured to deform the irrigation valve <NUM> and aspiration vent valve <NUM>, respectively, to block flow of fluid through the flow channel <NUM> positioned next to the irrigation valve <NUM> and aspiration vent valve <NUM>. Specifically, for example, when the irrigation valve plunger <NUM> and the aspiration vent plunger <NUM> are engaged into the flow channel <NUM>, the end surfaces <NUM> and <NUM> may be configured to contact or seal with the back surface <NUM> of the front housing <NUM>, reducing or completely stopping the flow of fluid through the flow channel <NUM>. In illustrative embodiments, the end surface <NUM> and <NUM> may abut against the valve control surfaces <NUM> (having the irrigation valve <NUM> and aspiration vent valve <NUM> sealing with the valve control surfaces <NUM>) to reduce or eliminate flow of fluid.

In illustrative embodiments, the end surfaces <NUM> and <NUM> and the valves <NUM> and <NUM> are generally configured to be similar in size and shape, in order for the end surfaces <NUM> and <NUM> to deform the valves <NUM> and <NUM>. As the end surfaces <NUM> and <NUM> engage with the valves <NUM> and <NUM>, it is desirable to avoid any potential for asymmetrical loading or otherwise deforming the valves in such a way that would compromise the sealing. Further, by ensuring an evenly distributed load distribution, the overall force required upon the plunger (e.g. by the solenoid) may be reduced to a minimal level required to engage the valves.

In illustrative embodiments, the irrigation valve plunger <NUM> and irrigation valve <NUM> are configured with a positioning feature <NUM> to avoid asymmetrical loading upon the valve <NUM>,---as illustrated in <FIG>, <FIG>, <FIG>, <FIG>, <FIG> and <FIG>, for example. Positioning feature <NUM> includes a locking recess <NUM> on a back surface <NUM> of irrigation valve <NUM>, the locking recess <NUM> being positioned along the back surface <NUM> of gasket <NUM>. Locking recess <NUM> is formed between two spaced-apart teeth <NUM> of positioning feature <NUM> that extend axially away from (and are generally perpendicular to) the back surface <NUM>, as illustrated for example in <FIG>, <FIG>, <FIG>, and <FIG>. Positioning feature <NUM> further includes a blade tooth <NUM> that extends axially away from the end surface <NUM> of the irrigation valve plunger <NUM>. In illustrative embodiments, blade tooth <NUM> is configured to be received with the locking recess <NUM> formed by the spaced-apart teeth <NUM> and to engage with the irrigation valve <NUM>. As the irrigation valve plunger <NUM> engages with the irrigation valve <NUM>, blade tooth <NUM> may abut against the back surface <NUM> of the irrigation valve <NUM> between the spaced-apart teeth <NUM>. Accordingly, positioning feature <NUM> ensures irrigation valve plunger <NUM> is properly aligned with irrigation valve <NUM> as irrigation valve plunger <NUM> is moved toward irrigation valve <NUM>, for uniform contact therewith, and further permits irrigation valve <NUM> to be deformed uniformly by irrigation valve plunger <NUM> when irrigation valve plunger <NUM> applies force to irrigation valve <NUM>. Locking recess <NUM> and blade tooth <NUM> may be generally each aligned along a first axis A1.

In illustrative embodiments, and as illustrated in <FIG>, blade tooth <NUM> may include a first contact surface <NUM> and a second contact surface <NUM>. Similarly, as illustrated in <FIG> and <FIG>, spaced-apart teeth <NUM> may include first and second receiving surfaces <NUM> and <NUM>. As blade tooth <NUM> is received within locking recess <NUM>, first contact surface <NUM> may engage with or abut against first receiving surface <NUM>, and second contact surface <NUM> may engage with or abut against second receiving surface <NUM>.

First contact surface <NUM>, second contact surface <NUM>, first receiving surface <NUM>, and second receiving surface <NUM> may be configured in a variety of shapes or sizes. For instance, first contact surface <NUM> may exist is a single plane P1, and second contact surface <NUM> may exist in a single plane P2, where plane P1 is parallel to plane P2, as illustrated in <FIG>. First and second receiving surface <NUM> and <NUM> may mirror first and second contact surfaces <NUM> and <NUM> and each exist in a single plane. Alternatively, first contact surface <NUM> may be convex or concave in nature, and second contact surface <NUM> may be oppositely convex or concave in nature. First and second receiving surfaces <NUM> and <NUM> may again mirror the first and second contact surfaces <NUM> and <NUM> to abut against the convex or concave first and second contact surfaces <NUM> and <NUM>, as illustrated in <FIG>. Other shapes or forms of first contact surface <NUM>, second contact surface <NUM>, first receiving surface <NUM>, and second receiving surface <NUM> are envisioned herein. First and second receiving surfaces <NUM> and <NUM> may be spaced apart distance D2, as illustrated in <FIG> and <FIG>, to receive blade tooth <NUM>.

In illustrative embodiments, first receiving surface <NUM> may include a first angled portion <NUM> and a second angled portion <NUM>, where the first angled portion <NUM> extends from a bottom circumference surface of the teeth <NUM> to generally a center axis C of the teeth <NUM>, and the second angled portion <NUM> extends from a top circumference surface of the teeth <NUM> to generally the center axis C, as illustrated in <FIG>. As illustrated in <FIG>, first angled portion <NUM> may extend at a first angle <NUM> from axis A1, and second angled portion <NUM> may extend at a second angle <NUM> from axis A1, whereby the second angle <NUM> is different than the first angle <NUM>. Accordingly, the teeth <NUM> may be shaped differently along the first angled portion <NUM> and second angled portion <NUM>. In another embodiment, the first angle <NUM> and the second angle <NUM> may be similar or the same.

In illustrative embodiments, blade tooth <NUM> may further include an end cap <NUM> that is configured to further guide blade toot into locking recess <NUM>. In an exemplary embodiment, as illustrated in <FIG>, end cap <NUM> may include tapered sides <NUM>. Tapered sides <NUM> may engage with and abut against corresponding tapered surfaces <NUM> that extend between the back surface <NUM> of the irrigation valve and first and second receiving surfaces <NUM> and <NUM>.

In illustrative embodiments, the aspiration vent valve plunger <NUM> and aspiration vent valve <NUM> are configured with a positioning feature <NUM> respectively, to avoid asymmetrical loading upon the valve <NUM>, as illustrated for example in <FIG>, <FIG>. The positioning feature <NUM> may be substantially similar to the positioning feature <NUM> described above. For instance, positioning feature <NUM> includes a locking recess <NUM> on a back surface <NUM> of aspiration vent valve <NUM>, the locking recess <NUM> being positioned along the back surface <NUM> of gasket <NUM>. Locking recess <NUM> is formed between two spaced-apart teeth <NUM> of positioning feature <NUM> that extend axially away from (and are generally perpendicular to) the back surface <NUM>, as illustrated for example in <FIG>, <FIG>, <FIG>, <FIG>, and <FIG>. Positioning feature <NUM> further includes a blade tooth <NUM> that extends axially away from the end surface <NUM> of the aspiration vent valve plunger <NUM>. In illustrative embodiments, blade tooth <NUM> is configured to be received with the locking recess <NUM> formed by the spaced-apart teeth <NUM> and to engage with the aspiration vent valve <NUM>. As the aspiration vent valve plunger <NUM> engages with the aspiration vent valve <NUM>, blade tooth <NUM> may abut against the back surface <NUM> of the aspiration vent valve <NUM> between the spaced-apart teeth <NUM>. Accordingly, positioning feature <NUM> ensures aspiration vent valve plunger <NUM> is properly aligned with aspiration vent valve <NUM> as aspiration vent valve plunger <NUM> is moved toward aspiration vent valve <NUM>, for uniform contact therewith, and further permits aspiration vent valve <NUM> to be deformed uniformly by aspiration vent valve plunger <NUM> when aspiration vent valve plunger <NUM> applies force to aspiration vent valve <NUM>. Locking recess <NUM> and blade tooth <NUM> may be generally each aligned along a second axis A2.

In illustrative embodiments, blade tooth <NUM> may include a first contact surface <NUM> and a second contact surface <NUM>. Similarly, spaced-apart teeth <NUM> may include first and second receiving surfaces <NUM> and <NUM>. As blade tooth <NUM> is received within locking recess <NUM>, first contact surface <NUM> may engage with or abut against first receiving surface <NUM>, and second contact surface <NUM> may engage with or abut against second receiving surface <NUM>.

First contact surface <NUM>, second contact surface <NUM>, first receiving surface <NUM>, and second receiving surface <NUM> may be configured in a variety of shapes or sizes. For instance, first contact surface <NUM> may exist is a single plane P1, and second contact surface <NUM> may exist in a single plane P2, where plane P1 is parallel to plane P2. First and second receiving surface <NUM> and <NUM> may mirror first and second contact surfaces <NUM> and <NUM> and each exist in a single plane. Alternatively, first contact surface <NUM> may be convex or concave in nature, and second contact surface <NUM> may be oppositely convex or concave in nature. First and second receiving surfaces <NUM> and <NUM> may again mirror the first and second contact surfaces <NUM> and <NUM> to abut against the convex or concave first and second contact surfaces <NUM> and <NUM>. Other shapes or forms of first contact surface <NUM>, second contact surface <NUM>, first receiving surface <NUM>, and second receiving surface <NUM> are envisioned herein. First and second receiving surfaces <NUM> and <NUM> may be spaced apart distance D1, as illustrated in <FIG> and <FIG>, to receive blade tooth <NUM>. Distance D1 may be smaller than, the same as, or larger than distance D2, depending on the design of the valves <NUM> and <NUM> and the cassette <NUM>.

In illustrative embodiments, first receiving surface <NUM> may include a first angled portion <NUM> and a second angled portion <NUM>, where the first angled portion <NUM> extends from a bottom circumference surface of the teeth <NUM> to generally a center axis C of the teeth <NUM>, and the second angled portion <NUM> extends from a top circumference surface of the teeth <NUM> to generally the center axis C. As illustrated in <FIG>, first angled portion <NUM> may extend at a first angle <NUM> from axis A2, and second angled portion <NUM> may extend at a second angle <NUM> from axis A2, whereby the second angle <NUM> is different than the first angle <NUM>. Accordingly, the teeth <NUM> may be shaped differently along the first angled portion <NUM> and second angled portion <NUM>.

In illustrative embodiments, blade tooth <NUM> may further include an end cap <NUM> that is configured to further guide blade tooth into locking recess <NUM>. In an exemplary embodiment, as illustrated in <FIG>, end cap <NUM> may include tapered sides <NUM>. Tapered sides <NUM> may engage with and abut against corresponding tapered surfaces <NUM> that extend between the back surface <NUM> of the vent valve <NUM> and first and second receiving surfaces <NUM> and <NUM>.

In illustrative embodiments, blade tooth <NUM> may be fixedly coupled to a rectangular base <NUM> that is retained within the console <NUM>, as illustrated in <FIG>. The base <NUM> may be configured to be received within a similarly-shaped aperture (not shown) of console <NUM> to prevent or reduce unintended rotation of blade tooth <NUM>, thereby preventing or reducing misalignment with the locking recess <NUM>.

In an embodiment, surgical cassette manifold <NUM> may be made substantially of a plastic material except for gasket <NUM>. The plastic material may be acrylonitrile-butadiene-styrene (ABS), polycarbonate (PC), polyethylene, viton, or other rigid plastic or plastic material. In addition, the material may be such that it is transparent enabling a user to visualize various features of surgical cassette manifold <NUM>. For example, all components may be transparent, including reservoir <NUM>. In an embodiment, one or more lights emitted from console <NUM> may be shone through surgical cassette manifold <NUM> to provide a backlight and allow a user to visualize the fluid flow as it flows from handpiece <NUM> through sealed fluid flow channel <NUM> into reservoir <NUM> and out to the drain bag <NUM>. In an embodiment, the backlight may also be used as a surgical cassette manifold type detector.

Claim 1:
A surgical system, comprising:
a console (<NUM>), the console including one or more moveable plungers (<NUM>, <NUM>);
a cassette (<NUM>), the cassette including a front plate (<NUM>) and a gasket (<NUM>) comprising one or more deformable valves (<NUM>, <NUM>), the one or more valves configured to generally align with the one or more plungers (<NUM>, <NUM>) when the cassette is connected to the console; and
a positioning feature (<NUM>), the positioning feature (<NUM>) including spaced-apart teeth (<NUM>) coupled to a back surface of the one or more valves (<NUM>, <NUM>) and extending axially away from the back surface, the spaced-apart teeth (<NUM>) forming a locking recess (<NUM>), the positioning feature (<NUM>) further including a blade tooth (<NUM>) coupled to one or more plungers (<NUM>, <NUM>), the blade tooth (<NUM>) dimensioned similar to the dimension of the locking recess (<NUM>) to be received within the locking recess (<NUM>).