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 single disposable plastic cassette is generally used to collect effluent material. This single cassette requires a prime on every insertion. The cost per case is a very sensitive factor for surgeons, which includes balanced salt solution ("BSS") usage and cassette cost. Currently a significant portion of BSS is used during prime to fill the line from the BSS bottle to the pack. Time and coordination is also required for a non-sterile nurse to spike and hang the BSS bottle after the sterile nurse has inserted the cassette. This can slow down the setup procedure as the sterile nurse may be waiting for this to occur to start prime. The irrigation side of the cassette has maintained sterility, but since it is physically part of the cassette, it is disposed of at the end of a case, in some cases along with the BSS bottle.

<CIT> discloses a disposable aspirator cassette which includes a housing having first and second sealed ends. A partition mechanism enclosed within the housing divides its internal volume into first and second regions. First and second fluid flow ports are mounted on the first and second ends, to provide fluid flow paths into and from the first and second regions. When the first region is filled with liquid, its associated first port is connected to a vacuum source for sucking the liquid out of the region, whereby as the liquid is removed, the partition mechanism responds by decreasing the volume of the first region, and increasing the volume of the second region causing its second port to draw a vacuum for sucking fluid from an aspiration device connected to the second port. <CIT> discloses an irrigation/aspiration flow system for an ophthalmic surgical instrument which includes a pump and fluid-flow control valves, disposed to seal or open fluid-flow lines. The fluid-flow system includes a tubing cartridge and a pump/sensor cartridge, both of the cartridges being adapted to releasably and lockingly engage the instrument such that when the cartridges lockingly engage the instrument, fluid control valves control the flow of fluid through the portion of the fluid lines and housed within the cartridges. <CIT> discloses a device for irrigation and insufflation with blood pressure dependent pressure control. <CIT> discloses an irrigation/aspiration apparatus and cassette therefore.

The present invention provides a phacoemulsification system as recited in claim <NUM>. Optional features are recited in the dependent claims.

This disclosure is illustrated by way of example and not by way of limitation in the accompanying figure(s). The figure(s), 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.

The disclosed allows for the irrigation functionality of a phacoemulsification system to be decoupled from the aspiration, thus allowing for extended use of an irrigation cassette across multiple patients, minimizing cost per case, as well as setup time for the surgical center. 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 via interface <NUM>. 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 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. The handpiece <NUM> is 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) is also 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(s) <NUM> may be disposable. Alternatively, the conduit(s) or tubing line(s) 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.

<FIG> illustrates, in diagram 200A, console <NUM> (shown in <FIG>) receiving more than one cassette. Interface <NUM> (shown in <FIG>) is configured to receive multiple cassettes via two pack capture interfaces. In the illustrated example, cassette <NUM> includes an irrigation cassette 100A and an aspiration cassette 100B. The cassettes may be replaced at different intervals. For example, irrigation cassette 100A may be retained in the system for the duration of cases in one day, while aspiration cassette 100B may be replaced more frequently, such as after every use. A BSS source may be connected via a traditional spike 202A to irrigation cassette 100A. Aspiration cassette 100B connects to irrigation cassette 100A preferably via a check valve 204A. Aspiration cassette 100B includes irrigation out 206A and one or more aspiration tubing lines 208A. Tubing lines out 208A may connect to one or more system handpieces <NUM> via line <NUM> as shown in <FIG>. <FIG> illustrates diagram 200B showing irrigation cassette 100A and aspiration cassette 100B in a disconnected state. As shown, valve 204A, e.g. a check valve, connects to face seal channel 210B for irrigation out. In at least one embodiment, aspiration cassette 100B may make the connection to irrigation cassette 100A automatically during the aspiration cassette capture. <FIG> illustrates diagram <NUM> showing a rear view of irrigation cassette 100A and aspiration cassette 100B in an alternative embodiment. Aspiration cassette 100B has a channel for irrigation <NUM> which may include an elastomer for face seal <NUM>.

Irrigation cassette 100A may or may not have pressurized infusion. Within irrigation cassette 100A, valve 204A guarantees sterility of the irrigation cassette. Valve fluid that has touched the eye should not contact the irrigation in fluid. In at least one embodiment, a full prime of irrigation in, irrigation out, and aspiration would only need to occur at insertion of the irrigation cassette 100A and aspiration cassette 100B, which would typically occur at the beginning of the day. At the conclusion of a case, used aspiration cassette 100B may be discarded and replaced by a new aspiration cassette. At this point, a full prime would not be required. Instead, only an aspiration cassette prime, including irrigation out and aspiration, would need to be performed. As a result, this reduces the volume used during the case prime by <NUM>% based on tubing diameters, such as OPO71 tubing diameters.

The disclosed system provides invaluable and crucial cost and time benefits. For example, the cost of an irrigation cassette may be amortized over the surgical procedures scheduled for the day. Further, time is saved on priming the phacoemulsification system and time and money is saved on BSS usage as the BSS is used more efficiently.

Those of skill in the art will appreciate that the herein described apparatuses, engines, devices, systems and methods are susceptible to various modifications and alternative constructions. There is no intention to limit the scope of the invention to the specific constructions described herein. Rather, the herein described systems are intended to cover all modifications, alternative constructions, and equivalents falling within the scope of the invention as defined by the claims.

In the foregoing detailed description, it may be that various features are grouped together in individual embodiments for the purpose of brevity in the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that any subsequently claimed embodiments require more features than are expressly recited.

Claim 1:
A phacoemulsification system (<NUM>), comprising:
an irrigation cassette (100A) having at least one input (202A) for connection to a bottle or bag for irrigation;
an aspiration cassette (100B) having at least one input (208A) for providing aspiration from an eye and at least one output (206A) for providing irrigation to an eye; and
a link (204A) between the irrigation cassette (100A) and the aspiration cassette (100B) for providing an inter-cassette irrigation connection;
wherein the irrigation cassette (100A) includes no aspiration functionality such that the irrigation cassette (100A) is configured to be used for procedures on multiple patients and the aspiration cassette (100B) is configured to be replaced after each procedure.