Patent Description:
Cataracts affect more than <NUM> million Americans age <NUM> and older. And as the U. population ages, more than <NUM> million Americans are expected to have cataracts by the year <NUM>. Cataract surgery entails the removal of a lens of an eye that has developed clouding of the eye's natural lens, or opacification. As a result of opacification, light is unable to travel to the retina, thereby causing vision loss. Once vision becomes impaired, cataract surgery is a viable option with a high level of success. During cataract surgery, a surgeon replaces the clouded lens with an intraocular lens (IOL).

Certain surgical procedures, such as phacoemulsification surgery, have been successfully employed in the treatment of certain ocular problems, such as cataracts. Phacoemulsification surgery utilizes a small corneal incision to insert the tip of at least one phacoemulsification handheld surgical implement, or handpiece, through the corneal incision. The handpiece includes a needle which is ultrasonically driven once placed within the incision to emulsify the eye lens, or to break the cataract into small pieces. The broken cataract pieces or emulsified eye lens may subsequently be removed using the same handpiece, or another handpiece, in a controlled manner. The surgeon may then insert a lens implant into the eye through the incision. The incision is allowed to heal, and the result for the patient is typically significantly improved eyesight.

During the phacoemulsification process for cataract removal, a disposable plastic cassette is generally used to collect effluent material. The disposable plastic cassette may consist of a tubing cassette which has flow paths for fluid and one or more valves to stop fluid flow or adjust fluid flow. In the prior art, the valve actuation utilized for commercial phacoemulsification cassette packs is performed by means of a plunger attached to a solenoid which moves forward to push an elastomeric material such as silicone that would obstruct the flow of fluid. The problem with solenoid actuation is that the force exerted by the solenoid drops with time as the solenoid is actuated and hence is inconsistent. Additionally, the force from solenoid changes with stroke length.

One approach taught by <CIT> utilizes rotary moveable cartridge valves which are injection molded and engage in a complementary socket that when actuated reduces the orifice size and obstructs the flow of fluid for ophthalmic cassette application.

<CIT> discloses a valve having a valve housing which encloses a valve interior, at least one pressure-side inlet, at least one suction-side outlet, at least one elastically movable membrane which, depending on the internal pressure prevailing in the valve interior and a reference pressure on the wall of the valve interior, can be rolled up and down, thereby opening or closing at least one of the outlets on the suction side, and a magnetic actuating device with which the position of the elastically movable membrane can be influenced. <CIT> discloses a magnetic valve with a seal on an armature. The seal has an outer sealing ring clamped against the valve body, a support portion, a diaphragm part, and a sealing bolt mounted on a magnetic armature fitted in a guide tube of a magnetic head. <CIT> discloses a valve with a valve seating which has a sealing plate formed of a disc shaped flat spring encased in an elastomeric casing. The sealing plate is joined to an axially displaceable tie piece which is electromagnetically operated and screwed to the sealing plate. <CIT> discloses a ventilator flow valve. <CIT> discloses a solenoid valve. <CIT> discloses a valve comprising a circular valve seal face formed by the underside of a rim of an elastomeric valve boss and a circular valve seat, which is formed by the rim of a through-hole molded into, for example, a plastic cassette, such that the valve seal face, the valve seat, and the through hole are concentric. If no force is applied to the inside surface of the valve boss, no fluid can pass through the valve as the valve seal face rests against the valve seat as a result of the steady free-state load created by the stretch of the valve boss over the slightly longer through hole. When a force is applied to the inside surface of the valve boss, the valve seal face is displaced from the valve seat, allowing fluid to flow between the valve seal face and valve seat and to pass between the valve boss and the inside surface of the through hole. <CIT> discloses a throttle device for changing the amount of air that can be passed through an intake pipe for an internal combustion engine, comprising a sealing body movable between a closed position and an open position, a device for moving the sealing body, a sealing seat for supporting the sealing body in the closed position with a flow opening for passing air through, so that in the open position the flow opening is open and in the closed position the flow opening is closed by the sealing body. <CIT> discloses a miniature vibration motor.

The present invention provides an elastomeric diaphragm actuator valve as recited in claim <NUM> and a method for actuating an elastomeric diaphragm actuator valve as recited in claim <NUM>. Optional features are recited in the dependent claims. In a preferred embodiment, the elastomeric valve material may comprise a flexible rubber-like material with a steel disc embedded in its wall. Other material other than a steel disc may be used in alternative embodiments, as long as the material attracts an electromagnet. In response to an electric current being applied to an electromagnet, a magnetic field attracts, in accordance with the preferred embodiment, the steel disc embedded in the elastomeric valve material. The elastomeric valve would then move towards the electromagnet. In the preferred embodiment, the electromagnet would be placed opposite the elastomeric valve that attracts the disc and closes the pathway of fluid flowing in the channel across.

This disclosure is illustrated by way of example and not by way of limitation in the accompanying figure(s). The figure(s) may, alone or in combination, illustrate one or more embodiments of the disclosure. Elements illustrated in the figure(s)
are not necessarily drawn to scale. Reference labels may be repeated among the figures to indicate corresponding or analogous elements.

The detailed description makes reference to the accompanying figures in which:.

The figures and descriptions provided herein may have been simplified to illustrate aspects that are relevant for a clear understanding of the herein described apparatuses, systems, and methods, while eliminating, for the purpose of clarity, other aspects that may be found in typical similar devices, systems, and methods. Those of ordinary skill may thus recognize that other elements and/or operations may be desirable and/or necessary to implement the devices, systems, and methods described herein. But because such elements and operations are known in the art, and because they do not facilitate a better understanding of the present disclosure, for the sake of brevity a discussion of such elements and operations may not be provided herein. However, the present disclosure is deemed to nevertheless include all such elements, variations, and modifications to the described aspects that would be known to those of ordinary skill in the art.

Embodiments are provided throughout so that this disclosure is sufficiently thorough and fully conveys the scope of the disclosed embodiments to those who are skilled in the art. Numerous specific details are set forth, such as examples of specific components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. Nevertheless, it will be apparent to those skilled in the art that certain specific disclosed details need not be employed, and that exemplary embodiments may be embodied in different forms. As such, the exemplary embodiments should not be construed to limit the scope of the disclosure. As referenced above, in some exemplary embodiments, well-known processes, well-known device structures, and well-known technologies may not be described in detail.

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 be disposable or comprise a disposable (or alternatively, re-sterilizable) 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.

In illustrative embodiments, a surgical cassette <NUM>, such as the one illustrated in <FIG> and <FIG>, may be configured to be coupled and removed from the console <NUM> after use during a surgical procedure and may include at least one valve <NUM>. In conjunction with electromagnet <NUM>, fluid flow may be controlled through flow path <NUM> by the at least one valve <NUM>, as described below.

<FIG> illustrate embodiments of a valve which may, for example, be used in a surgical cassette of the present invention. The valve is electromagnetic and may, for example, be controllable through a surgical console. The use of an electromagnetic valve over a traditional valve, such as one associated with a solenoid, allows for a smaller valve size as a solenoid may be bulky in construction. Further, an electromagnetic valve has no need for the use of an additional plunger attachment to interface with the valve, therefore reducing the number of components for assembly. Additionally, an electromagnetic valve does not experience any variation in force due to stroke length setting such as when assembling a plunger onto a solenoid.

<FIG> illustrates an embodiment of an electromagnetic valve 200A in a retracted state. The valve may include, on a fixed end, an elastomeric diaphragm 202A connected to a steel disc 204A. The steel disc 204A may have magnetic properties. The use of a steel disc is merely meant to be exemplary. It is understood that other magnetic materials may be utilized, such as iron, nickel, cobalt or other rare earth materials that exhibit magnetic behavior. Disc 204A may also take on different geometrical shapes. As shown, the disc 204A in its simplest form may take on a circular shape. However, it is understood that the circular shape is not meant to be limiting. For example, the disc may take on an oval or ellipsoid shape, among others. In yet another embodiment, the disc 204A may take on a custom shape formation to match the fluid flow path <NUM> and a mating surface. <FIG> shows the magnetic material embedded in the wall 201A to form a disc being in a relaxed state. In an alternative embodiment, the magnetic material, such as the disc, may be affixed to the inside of the elastomeric diaphragm 202A, such as with glue or any other type of adhesive substance. In another exemplary embodiment, the magnetic material may be fully or partially encased within the elastomeric diaphragm. If partially encased, portions of the magnetic material may be exposed.

For example, the valve is open and allows the flow along fluid flow path 206A. The valve may include a strong electromagnet 208A that, when demagnetized (e.g., no current), enables disc 204A to be in a relaxed, or retracted, state. In yet another embodiment, fluid flow rate may be controlled by a combination of magnetization and demagnetization resulting in a narrowing of the pathway 206A.

<FIG> illustrates an embodiment of an electromagnetic valve 200B in an extended state. The valve may include, on a fixed end, an Elastomeric Diaphragm 202A connected to a steel disc 204A. In this example, elastomeric diaphragm 202A may be attached to the cassette body and retract from the electromagnet 208A. The steel disc 204A may have magnetic properties as described above with respect to <FIG> shows the magnetic material embedded in the wall to form a disc being in a relaxed state. For example, the valve is closed and blocks the flow of fluid along Fluid Flow Path 206B. Fluid flow path 206B may be a rigid molded channel in a shape that is complementary to the disc shape, for example. The valve may include a strong electromagnet 208B that, when magnetized (e.g., magnetized by current), enables and causes disc 204A to be in an extended state.

In an alternative embodiment, the diaphragm 202A and disc 204A may use magnetic materials embedded in an elastomeric matrix and may use electromagnet 208A to repel the valve to an open state. In this embodiment, when the electromagnet 208A is demagnetized, or a non-magnetized state, the elastomeric matrix magnet will be attracted to the electromagnet due to the presence of magnetic materials, such as an iron core, for example.

In yet another alternative embodiment of the disclosed invention, the diaphragm 202A and disc 204A may be comprised of elastomeric rubber valve materials coated with a thin layer of magnetic material (for e.g. a layer of nickel particles/fibers), such as magnetic fibers, which may attract electromagnet 208A. The thin layer of magnetic fiber coating may be utilized in place of an embedded magnetic/steel disc.

Elastomeric elements of the valve may help create a seal and completely occlude fluid flow by compressing the elastomer when the disc is attracted. When the electromagnet current stops flowing through a coil of the electromagnet, the elastomeric valve is no longer attracted towards the electromagnet and thus retracts back to open the flow path.

In an embodiment of the present invention, the electromagnetic valve may be controlled by aspects of controller <NUM> which may be operatively connected to the electromagnetic coil(s). The controller <NUM> may calculate an opening/closing timing for the valve based on various data, such as, real time operating parameters, user defined parameters, and/or a combination of both. The CPU may alternatively energize the electromagnetic coil(s) at the opening/closing timing, thus opening or closing the valve. Similarly, the valve may be controlled such that a partial flow may occur by only partially actuating the valve. For example, the controller may only activate a portion of the electromagnet which may only draw a portion of the valve into a substantially closed position allowing for more control over the flow of fluid.

Claim 1:
An elastomeric diaphragm actuator valve (<NUM>), comprising,
a housing;
an electromagnet (208A, 208B) contained by the housing;
an elastomeric diaphragm (202A); and
a fluid pathway (<NUM>) between the housing and the elastomeric diaphragm; characterized in that the elastomeric diaphragm (202A) is coated with one or more magnetic materials,
wherein the electromagnet and elastomeric diaphragm are arranged such that the one or more magnetic materials that are coated on the elastomeric diaphragm (202A) are attracted to the housing in response to activation of the electromagnet (208A, 208B) and repelled from the housing in response to deactivation of the electromagnet (208A, 208B).