Patent Application
20220288287
The present invention is generally related to methods, devices, and systems for controlling and identifying the use of surgical cassettes, 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: 1) volumetric-based aspiration flow systems using positive displacement pumps; and 2) 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 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. U.S. Pat. Nos. 8,070,712 and 9,295,765 provide examples of cassettes currently used in the marketplace, the contents of each are herewith incorporated by reference in their entirety as if set forth herein.
With some surgical systems in the art, cassettes having the same size and shape may be forward or backwards compatible with different system and may have different functionality associated with each. Since attributes and functionality may vary between cassettes that share the same standard size and shape there needs to be a mechanism to ensure only cassettes compatible with a system are used and the system operates correctly based on the type of compatible cassette is used to avoid unintended operational failures.
In light of the above, it would be advantageous to provide improved devices, systems, and methods for the identification of surgical cassettes.
The present invention provides for an eye surgical system, comprising a cassette having at least two body portions and a console, wherein the console comprises a cassette receptacle configured to couple the cassette with the console, the cassette receptacle comprises a cassette preload detection system, the body portions of the cassette are configured to contact the cassette pre-load detection system, and wherein the configuration of the body portions identifies a type of cassette coupled with the console. The cassette pre-load detection system may comprise two detection switches and the two detection switches may be proximate to each other. Each type of cassette may correspond to a console compliant attribute selected from the group consisting of tubing diameter, tubing material, tubing thickness, tubing length, vacuum pressure limit, aspiration pressure limit, fluid flow rate; and irrigation rate. The body portion of the cassette may be configured to contact one of two detection switches which may be proximate to the top of the cassette body and may comprise a microswitch, piezometer, or an optical switch. The console may receive an indication of the depth of one of the body portions of a cassette from one of the detection switches and may receive an indication of a body portion from one of the detection switches. The console may also operate in accordance with the cassette type identified.
The present invention provides for a surgical console configured to receive multiple types of eye treatment cassettes, comprising a cassette receptacle for interchangeably receiving multiple types of cassettes, wherein the console operates with a first type of cassette and does not operate with a second type of cassette, and a console controller for receiving an indication of the type of cassette received by the cassette receptacle and controlling the operation of the console. A cassette type indication may be generated by a cassette pre-load detection system and the indication received may be from a detection switch. The indication may be indicative of the depth of a body portion of the first type of cassette or second type of cassette.
The present invention provides a method for identifying multiple types of eye treatment cassettes, comprising interchangeably receiving the multiple types of eye treatment cassettes in a cassette receptacle of a surgical console, enabling operation of the console when a first type of cassette is received, and receiving an indication of the first type of cassette from one of at least two pre-load detection switches. The second type of cassette may be configured to contact each of the two pre-load detection switches and the pre-load detection switches may comprise a microswitch or an optical switch, for example.
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, and equivalents, which may be included within the spirit and scope of the invention as defined by the appended claims.
Referring to
When a distal end of the probe tip of handpiece 12 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 14 to an ultrasound transmitter of the handpiece, a cutter mechanism, or the like. Alternatively, the handpiece 12 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 12 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 12 (or a separate probe structure) may also be provided, with both the aspiration and irrigations flows being controlled by console 14.
So as to avoid cross-contamination between patients without incurring excessive expenditures for each procedure, cassette 100 and its flexible conduit 18 may be disposable. Alternatively, the flexible 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 14, which may include one or more peristaltic pump rollers, a Venturi or other vacuum source, a controller 40, and the like.
Controller 40 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 42), and the like. Controller 40 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 40 may have (or be coupled to) a recording media reader, or the code may be transmitted to controller 40 by a network connection such as an internet, an intranet, an Ethernet, a wireless network, or the like. Along with programming code, controller 40 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 14 may be found in or modified from known commercial phacoemulsification systems, such as those from Johnson & Johnson Surgical Vision, Inc. of Santa Ana, Calif.
In an embodiment, surgical cassette 100 may include drain bag port 103. As illustrated in
Surgical cassette 100 may also include one or more damping domes 106. As illustrated in
In an embodiment, surgical cassette 100 may include irrigation inlet tubing port 107, irrigation outlet tubing 108, and aspiration outlet tubing 109. Irrigation inlet tubing port 107 may be a connection port for tubing extending to the balance salt solution (BSS) irrigation bottle to deliver irrigation fluid to fluid flow channels in surgical cassette 100 (not shown). irrigation outlet tubing 108 may extend to the surgical handpiece 12 to deliver irrigation fluid to patient's eye E. Aspiration outlet tubing 109 may extend to the surgical handpiece 12 for removing fluid from a patient's eye E by means of a pump, such as a flow-based pump, preferably a peristaltic pump, for example.
Detection switch 316 may be a spring-loaded pin displaced rearwards when surgical cassette 100 is initially inserted with an end or side surface triggering a switch and initiating closure of damps 318, 319. Detection switch 316 may be a switch component that changes electrical output state when cassette displaced to a specific axial position indicating surgical cassette 100 is in an appropriate position for loading engagement by clamps 318, 319, for example, and may identify the surgical cassette 100 and confirm functionality and/or compatibility with the console 14.
In an embodiment of the invention, console 14 may be configured to receive various types of cassettes. To this end, console 14 and the cassette may communicate to establish the functionality of the mounted cassette (i.e., the modes of aspiration enabled by the cassette). In one approach, a cassette may include a body portion that may be detected by the console and which identifies the available functionalities of the installed cassette. For example, with reference to
Conversely, if the detection switch 316 is not triggered, the console may be informed that a second type of cassette 100 is loaded into cassette receptacle 300. In an embodiment of the present invention, with reference to
In an embodiment of the invention, with reference to
In an embodiment of the present invention, body portions 404, 402 of cassette 100 may be of differing depths from back plane 406, which defines the leading edge of the cassette body as positioned towards the cassette receptacle 300. As illustrated in
In an embodiment of the present invention, an indication of cassette type may prompt controller 40 to provide a message to the user of console 14 through user interface 42 which may include, for example, an indicator that the cassette type is not compatible with the console or which system attributes have been selected by the console 14 to be compatible with the cassette 100. For example, a first type cassette may be compatible with a dual pump eye treatment system while a second type cassette may be compatible with a dual pump eye treatment system that also provides for pressurized infusion. Similarly, various cassette types may require certain settings (e.g. vacuum, aspiration, flow, irrigation, etc.) for optimum performance due to physical characteristics of the components of the cassette, e.g. tubing material(s) and compliance, inner and/outer diameter of the tubing, wall thickness of the tubing, length of the tubing, etc. The physical characteristics between cassettes types may differ, but still operate with the same console or some cassettes may be incompatible. The present invention permits cassette identification and system configuration to ensure proper cassette usage and settings.
All references cited herein are hereby incorporated by reference in their entirety including any references cited therein.
Although the present invention has been described in terms of specific embodiments, changes and modifications can be carried out without departing from the scope of the invention which is intended to be limited only by the scope of the claims.
