Patent Description:
Fluids are typically injected into a patient's eye during an ophthalmic surgery in order to maintain the intraocular pressure of the eye at an acceptable level. Some ophthalmic surgical systems provide such fluid from a bag placed under physical pressure by an actuator mechanism. The actuator mechanism squeezes the bag to push fluid out of the bag and into an infusion line. The infusion line provides fluid communication between the bag and the ophthalmic surgical tool that injects the fluid into the patient's eye. Some ophthalmic surgical systems provide such fluid through use of a bottle. Typically, the bottle has an infusion outflow port at the bottom of the bottle, which can be connected to the fluid infusion line. The bottle also has a pressure inlet at the top of the bottle. The pressure inlet is connected to a pressurized fluid source such as a pressurized gas. When the pressurized gas is injected into the bottle, it pushes fluid out of the infusion outflow port. In some examples, the fluid is pushed into a cassette chamber. In some examples, the fluid is pushed into the fluid infusion line.

The ophthalmic surgical systems that provide fluid infusion, among other functions, typically do so through use of a fluid delivery system integrated with a console. For example, the fluid delivery system for an ophthalmic surgical system may include a space for placing the bag or bottle while the bag or bottle is connected to the fluid delivery system. In some cases, the bags or bottles may come packaged with the infusion fluid therein. However, such fluid is not typically degassed. In other words, there may be gas bubbles within the infusion fluid or gas that is dissolved into the infusion fluid. An infusion fluid that is not degassed may introduce gas bubbles into the patient's eye during the infusion process. Such gas bubbles may obscure an operator's vision during the ophthalmic surgical operation being performed.

Reference is made to <CIT> and <CIT> which have been cited as relating to the state of the art. <CIT> discloses a medical fluid injection system, comprising: two medical fluid reservoirs and two pressurizing units.

It will be appreciated that the scope of the invention is in accordance with the claims. Accordingly, there is provided a fluid delivery system, as defined in claim <NUM>. Further there is provided a method as defined in claim <NUM>. Further features are provided in the dependent claims.

According to one example, a fluid delivery system includes a pressure source capable of producing both positive and negative fluid pressure, a fluid infusion line, and a first fluid storage container. The first fluid storage container includes a chamber, a fluid outflow port that is connectable to the fluid infusion line to provide fluid communication between the chamber and the fluid infusion line, a pressure inlet that is connectable to the pressure source, and a filter disposed between the pressure inlet and the chamber. The fluid delivery system further includes a control system configured to cause the fluid pressure source to apply both negative pressure and positive pressure.

A method includes connecting a pressure source of a fluid delivery system to a pressure inlet of a fluid storage container, the pressure inlet comprising a filter that allows gas to pass therethrough, connecting a fluid infusion line of the fluid delivery system to a fluid outflow port of the fluid storage container, and applying a negative pressure to the fluid storage container to degas a liquid within the fluid storage container.

A fluid delivery system includes a pressure source capable of producing both positive and negative fluid pressure, a fluid infusion line, a fluid source, and a first fluid storage container. The first fluid storage container includes a first fluid storage chamber, a first infusion outflow port that is connectable to the fluid infusion line, a first fluid inflow port that is connectable to the fluid source, and a first pressure inlet that is connectable to the fluid pressure source, the first pressure inlet comprising a first filter. The fluid delivery system further includes a control system configured to fill the fluid storage chamber with infusion fluid for a first period of time and cause the fluid pressure source to apply a negative pressure to the first fluid storage container for a second period of time following the first period of time.

The accompanying drawings illustrate the devices and methods disclosed herein and together with the description, serve to explain the principles of the present disclosure.

It will nevertheless be understood that no limitation of the scope of the disclosure is intended. Any alterations and further modifications to the described devices, instruments, methods, and any further application of the principles of the present disclosure are fully contemplated as would normally occur to one skilled in the art to which the disclosure relates. For simplicity, in some instances the same reference numbers are used throughout the drawings to refer to the same or like parts.

The present disclosure is directed to a fluid delivery system and a fluid storage container adapted to degas a fluid within a fluid storage container before that fluid is infused into the patient's eye. According to some examples, the fluid storage container includes an infusion outflow port and a pressure inlet. The pressure inlet includes a filter such as a semi-permeable membrane. Before the fluid is infused into the patient's eye, a vacuum is applied through the filter. The filter prevents the liquid infusion fluid from exiting the bag, while permitting passage of gas bubbles through the filter. In this manner, the infusion fluid can be degassed before it is infused into the patient's eye. The fluid delivery system and fluid storage container will be described in further detail below.

<FIG> is a diagram showing an illustrative ophthalmic surgical system <NUM>. According to the present example, the ophthalmic surgical system <NUM> includes a surgical console <NUM> and an ophthalmic surgical tool <NUM>. The ophthalmic surgical tool <NUM> is in fluid communication with the console <NUM> through a fluid infusion line <NUM>. The surgical console <NUM> includes a display screen <NUM> and a fluid delivery system <NUM>. In one implementation, the surgical console <NUM> is configured to be mobile and may be used by a user, such as a health care provider, to perform ophthalmic surgical procedures. The surgical console <NUM> may also include a control system <NUM> that may be configured to process, receive, and store data to perform various functions associated with the ophthalmic surgical tool <NUM>.

The display screen <NUM> may communicate information to the user, and in some implementations, may show data relating to system operation and performance during a surgical procedure. In some examples, the display screen <NUM> is a touchscreen that allows the operator to interact with the surgical console <NUM> through a graphical user interface.

The fluid delivery system <NUM> may include a cassette <NUM> that is removably insertable into the fluid delivery system <NUM>. In some examples, the cassette <NUM> may include components of the fluid delivery system <NUM> that may come into contact with patient fluids and tissue. Specifically, the cassette <NUM> may include a fluid storage container and the fluid infusion line <NUM>. In some examples, the cassette <NUM> may include components of other systems such as an aspiration system (not shown).

<FIG> is a diagram showing an illustrative fluid delivery system <NUM> with a fluid storage container <NUM>. The fluid delivery system <NUM> may correspond to the fluid delivery system <NUM> described above. According to the present example, the fluid delivery system <NUM> includes a pressure source <NUM> having a pump <NUM>, a fluid source <NUM>, and a fluid infusion line <NUM>. The fluid storage container <NUM> includes a fluid chamber <NUM> for storing infusion fluid <NUM>, a pressure inlet <NUM> with a filter <NUM>, a fluid inflow port <NUM>, and a fluid outflow port <NUM>.

As described above, the fluid delivery system <NUM> may utilize a cassette (e.g. <NUM>, <FIG>) that is insertable into the surgical console (e.g. <NUM>, <FIG>). The cassette may include the fluid storage container <NUM> and the fluid infusion line <NUM>. The cassette may be structurally configured such that, when inserted into the console, the fluid inflow port <NUM> and pressure inlet <NUM> are appropriately connected to the fluid source <NUM> and the pressure source <NUM>, respectively.

The pressure source <NUM> may be a compressor or pump that is integrated into the surgical console (e.g., <NUM>, <FIG>). In some examples, the pressure source <NUM> may be provided by a machine (e.g., a pump) separate from the console that is connectable to the surgical console through a pressure line. In either case, the pressure source <NUM> is connectable to the pressure inlet <NUM> of the fluid storage container <NUM> through the pressure line <NUM>, such as a conduit. The pressure line <NUM> provides fluid communication between the pressure inlet <NUM> and the pressure source <NUM>.

The pressure source <NUM> is configured to apply both positive and negative pressure relative to atmospheric pressure to the fluid storage container <NUM> through the pressure inlet <NUM>. Specifically, the pressure source <NUM> is adapted to apply a negative pressure (i.e., a vacuum) to the fluid storage container <NUM> to degas the infusion fluid <NUM> stored therein. The pressure source <NUM> is also adapted to apply positive pressure to push the infusion fluid <NUM> out of the fluid storage container <NUM>, through the fluid infusion line <NUM> and into a patient's eye.

In some examples, including the exemplary implementation in <FIG>, the pressure source <NUM> utilizes a Venturi pump <NUM> to apply negative pressure to the fluid storage container. In some examples, to apply a vacuum to the pressure inlet <NUM>, the pressure source causes a fluid to flow from the pressure source <NUM>, through the Venturi pump <NUM>, and to a muffler <NUM>. The Venturi pump <NUM> includes a narrower portion of tubing. Because speed increases through the narrow portion, pressure drops, thereby creating a vacuum. In this manner, the pressure source <NUM> can apply negative pressure to the pressure inlet <NUM>. Other types of pumps for providing a vacuum may be used as well.

While the exemplary implementation in <FIG> uses a single interface between the container <NUM> and the pressure source <NUM>, other implementations include two separate pressure interfaces; one for having positive pressure applied and one for having negative pressure applied. In such a case, two separate pressure lines may connect the two pressure interfaces to the pressure source <NUM>. In some cases, the pressure source that provides a positive pressure may be a separate piece of machinery than the pressure source that provides a negative pressure. In other words, there may be two separate pressure sources; one for providing positive pressure and one for providing negative pressure. For example, a pump may provide vacuum or negative pressure and a compressor may provide positive pressure.

The fluid source <NUM> provides an infusion fluid to the fluid storage container <NUM>. The infusion fluid may be, for example, a balanced salt solution (BSS). The infusion fluid may be provided to the fluid storage container <NUM> in any of a variety of manners. In one example, the fluid source <NUM> may include a fluid tank that is sized to hold a substantially larger quantity of fluid than the fluid storage container <NUM>. Such a fluid tank may then be used to fill the fluid storage container <NUM> with the infusion fluid as needed. In some examples, the fluid source <NUM> may be a fluid tank that is external to the surgical console <NUM>. In either case, the fluid storage container <NUM> is connectable to the fluid source <NUM> through a fluid line <NUM>. The fluid line <NUM> thus provides fluid communication between the fluid source <NUM> and the fluid inflow interface <NUM> of the fluid storage container <NUM>.

Still referring to <FIG>, the chamber <NUM> of the fluid storage container <NUM> is filled with an infusion fluid <NUM>. In some examples, the chamber <NUM> may be sized such that the amount of fluid within the chamber <NUM> is generally sufficient for a single surgical procedure. In some examples, however, the chamber <NUM> may be sized to hold a smaller quantity of infusion fluid. In such a case, the chamber <NUM> may be refilled during a surgical procedure.

The pressure inlet <NUM> may include a pressure interface <NUM> that allows the pressure inlet <NUM> to connect with the pressure line <NUM> such that a fluid-tight seal is formed. The pressure interface <NUM> may be a selectively attachable interface, such as a quick disconnect fitting or other interface. In some examples, the pressure interface <NUM> is a Luer fitting. The pressure inlet <NUM> allows fluid communication between the chamber <NUM> and the pressure source <NUM>. According to the present example, the pressure inlet <NUM> includes the filter <NUM>. The filter <NUM> is structurally configured to allow gaseous fluid to pass therethrough and prevent liquid fluid from passing therethrough. Thus, when a vacuum, such as negative pressure, is applied to the pressure inlet <NUM>, the gas within the chamber <NUM> and gas bubbles within the infusion fluid <NUM> can be pulled through the filter <NUM>. But, the infusion fluid <NUM> (i.e., BSS) is maintained within the fluid storage container and not pulled through the filter <NUM>.

The fluid inflow port <NUM> includes an interface <NUM> that allows the fluid inflow port <NUM> to connect to the fluid line <NUM> such that a fluid-tight seal is formed. The interface <NUM> may be a selectively attachable interface, such as a quick disconnect fitting or other interface. In some examples, the interface <NUM> is a Luer fitting. The fluid line <NUM> provides fluid communication between the fluid source <NUM> and the fluid inflow port <NUM>. The fluid inflow port <NUM> allows fluid communication between the chamber <NUM> and the fluid line <NUM>. In some examples, the fluid inflow port <NUM> may include a one-way valve that allows fluid to flow into the chamber <NUM> but prevents fluid from flowing out of the chamber <NUM>.

The fluid outflow port <NUM> includes an interface <NUM> that allows the fluid outflow port <NUM> to connect to the fluid infusion line <NUM> such that a fluid-tight seal is formed. The fluid outflow port <NUM> thus provides fluid communication between the chamber <NUM> and the fluid infusion line <NUM>. The fluid infusion line <NUM> provides fluid communication between the fluid outflow port <NUM> and the ophthalmic surgical tool <NUM> that injects the infusion fluid into the patient's eye. In some examples, the fluid outflow port <NUM> may include a one-way valve that allows fluid to flow out of the chamber <NUM> but prevents fluid from flowing into the chamber <NUM>. The fluid outflow port <NUM> may also include a stop valve <NUM> or check valve to selectively prevent or allow fluid from flowing through the fluid outflow port <NUM>.

During operation of the fluid delivery system, the control system (e.g. <NUM>, <FIG>) may manage the various components to direct fluid as desired. For example, after the cassette is inserted into the surgical console <NUM>, the chamber <NUM> may be empty. Thus, the control system <NUM> may operate a pump <NUM> to cause the fluid from the fluid source <NUM> to be pumped into the chamber <NUM> to fill the chamber. During this time, the stop valve <NUM> of the fluid outflow port <NUM> may be closed so as to prevent fluid from flowing out of the fluid outflow port <NUM>. In some examples, the infusion fluid <NUM> may be pumped into the chamber <NUM> until the fluid level reaches a certain threshold level <NUM> that is lower than the top of the chamber <NUM>.

After the chamber <NUM> has been appropriately filled with infusion fluid <NUM>, the control system <NUM> may apply a negative pressure to the pressure inlet <NUM> through use of the pressure source <NUM> and the pump <NUM>. The negative pressure, or vacuum, that is applied can degas the infusion fluid <NUM> stored within the chamber <NUM>. In other words, gas bubbles within the infusion fluid solution may be removed from the infusion fluid solution.

After the infusion fluid <NUM> has been degassed, the solution may be ready for infusion into the patient's eye. The control system <NUM> may thus apply positive pressure to the pressure inlet <NUM>. During this time, the stop valve <NUM> of the fluid outflow port <NUM> may be open so as to allow fluid flow therethrough. The positive pressure at the pressure inlet <NUM> causes the infusion fluid to be pushed out of the chamber <NUM>, into the fluid infusion line <NUM>, through the ophthalmic surgical tool <NUM>, and into the patient's eye. The magnitude of the positive pressure may be controlled so as to provide the desired flow rate of infusion fluid <NUM> to the patient's eye.

The control system <NUM> may include a processor and a memory. The memory may store machine readable instructions that when executed by the processor, cause the control system <NUM> to perform various tasks. For example, the control system <NUM> may send control signals to the pressure source <NUM> and the fluid source <NUM>. Such control signals may activate either the pressure source <NUM> or the fluid source <NUM> to behave as desired at designated points in time. For example, the control system <NUM> may cause the fluid source <NUM> to fill the fluid storage container <NUM> with fluid <NUM>. Then, the control system <NUM> may cause the pressure source <NUM> to apply a negative pressure to degas the fluid <NUM> within the fluid storage container <NUM>. The control system <NUM> may then cause the pressure source <NUM> to apply positive pressure to the fluid storage container <NUM> to push the fluid <NUM> out of the fluid storage container <NUM>.

<FIG> is a diagram showing an embodiment of a fluid delivery system <NUM> with dual fluid storage containers <NUM>, <NUM>. Like the first fluid storage container <NUM>, the second fluid storage container <NUM> includes a chamber <NUM> adapted to hold a quantity of fluid <NUM>, a pressure inlet <NUM> with a filter <NUM>, a fluid inflow port <NUM>, and a fluid outflow port <NUM>. In this example, however, the fluid line <NUM> includes a switch valve <NUM> that allows fluid from the fluid source <NUM> to be directed to either the first fluid storage container <NUM> or the second fluid storage container <NUM>. Similarly, the fluid infusion line <NUM> includes a switch valve <NUM> that allows fluid from either the first fluid storage container <NUM> or the second fluid storage container <NUM> to be directed to the ophthalmic surgical tool <NUM>.

According to the present example, the pressure lines <NUM>, <NUM> connect the pressure source to the pressure inlets <NUM>, <NUM> of the fluid storage containers <NUM>, <NUM> through a switch valve <NUM>. The first pressure line <NUM> may be used for applying positive pressure and the second pressure line <NUM> may be used for applying negative pressure. Thus, positive pressure may be applied to one fluid storage container while negative pressure is applied to the other and vice versa.

<FIG> is a flowchart showing a process <NUM> for providing fluid through the fluid delivery system <NUM> that includes the two fluid storage containers <NUM>, <NUM>. Steps performed on the first fluid storage container <NUM> are shown in the left column <NUM> and the steps performed on the second fluid storage container <NUM> are shown in the right column <NUM>. Reference numeral <NUM> identifies a starting point in time, where the first fluid storage container <NUM> is filled with infusion fluid and the second fluid storage container <NUM> is empty.

Between points in time identified by the reference numerals <NUM> and <NUM>, at step <NUM>, infusion fluid is pushed out of the first fluid storage container <NUM> by applying positive pressure to the pressure inlet <NUM> of the first fluid storage container <NUM>. Meanwhile, steps <NUM> and <NUM> are performed on the second fluid storage container <NUM>. At step <NUM>, the second fluid storage container <NUM> is filled with infusion fluid. After the second fluid storage container <NUM> is appropriately filled, at step <NUM>, the infusion fluid solution within the second fluid storage container <NUM> is degassed by applying a negative pressure to the pressure inlet <NUM> of the second fluid storage container <NUM>.

At the point in time <NUM>, after the fluid in the first fluid storage container <NUM> falls below a minimum fluid level, the process <NUM> switches. Specifically, between time points <NUM> and <NUM>, at step <NUM>, infusion fluid is pushed out of the second fluid storage container <NUM> by applying positive pressure to the pressure inlet <NUM>. Meanwhile, steps <NUM> and <NUM> are performed on the first fluid storage container <NUM>. At step <NUM>, the first fluid storage container <NUM> is filled with infusion fluid. After the first fluid storage container <NUM> is appropriately filled, at step <NUM>, the infusion fluid solution within the first fluid storage container <NUM> is degassed by applying a negative pressure to the pressure inlet <NUM> of the first fluid storage container <NUM>.

At time point <NUM>, the first fluid storage container <NUM> is filled with degassed fluid and the second fluid storage container <NUM> is empty. The process <NUM> may continue by switching between the fluid storage containers <NUM>, <NUM> as described above. Specifically, while infusion fluid is being pressurized out of one fluid storage container, the other fluid storage container is being filled and degassed. Thus, a steady flow of degassed infusion fluid can be provided to the patient's eye.

<FIG> and <FIG> are diagrams showing illustrative fluid delivery bags capable of being degassed before infusion. The fluid delivery bags may store an infusion fluid. The bags may be flexible so that when squeezed, the infusion fluid within is pressed out of the bag and into the patient's eye. For example, some surgical consoles (e.g., <NUM>, <FIG>) may include an actuator mechanism that squeezes a bag filled with fluid in order to provide pressurized infusion fluid into the patient's eye.

<FIG> illustrates an example in which the degassing interface <NUM> is at a top <NUM> of a bag <NUM>. In the present example, the bag <NUM> includes the degassing interface <NUM> with a filter <NUM>, an interior chamber <NUM>, and a fluid outflow port <NUM> with an outflow interface <NUM>. The outflow interface <NUM> may be connectable to a fluid infusion line (e.g., <NUM>, <FIG>). The degassing interface <NUM> may be connectable to a pressure source (e.g. <NUM>, <FIG>) through a pressure line. In this example, the degassing interface <NUM> includes a filter <NUM> that may allow gaseous fluids to pass through preventing liquid fluids from passing through. The filter <NUM> may be, for example, a semipermeable membrane. Thus, when a negative pressure is applied to the degassing interface <NUM>, gas bubbles within the infusion fluid solution may be pulled out of the solution. But, the infusion fluid does not pass through the filter <NUM>. Thus, the infusion fluid solution within the chamber <NUM> can be degassed.

<FIG> illustrates an example in which the degassing interface <NUM> is at a bottom <NUM> of a bag <NUM>. In the present example, the bag <NUM> includes the degassing interface <NUM> with a filter <NUM>, and a fluid outflow port <NUM> with an outflow interface <NUM>. The bag also includes a snorkel <NUM> that extends into the center portion of the chamber <NUM>. The fluid outflow port <NUM> may include an annular channel <NUM> that surrounds the snorkel <NUM>. The outflow interface <NUM> may be connectable to a fluid infusion line (e.g., <NUM>, <FIG>). Thus, fluid flowing out of the chamber <NUM> passes through the annular channel <NUM>, through the outflow interface <NUM>, and into a fluid infusion line. The degassing interface <NUM> may be connectable to a pressure source (e.g. <NUM>, <FIG>) through a pressure line. The degassing interface <NUM> includes a filter <NUM> that may allow gaseous fluids to pass through preventing liquid fluids from passing through. The filter <NUM> may be, for example, a semipermeable membrane. Thus, when a negative pressure is applied to the degassing interface <NUM>, gas bubbles within the infusion fluid solution may be pulled out the solution. Specifically, infusion fluid within the chamber <NUM> is pulled through the snorkel <NUM> against the filter <NUM>. But, the infusion fluid is not pulled through the degassing filter <NUM>. Thus, the infusion fluid solution within the chamber <NUM> can be degassed.

The snorkel <NUM> may be any suitable length. For example, the snorkel <NUM> may be relatively short and extend only a small distance from the bottom <NUM> of the bag <NUM>. In some examples, the snorkel <NUM> may be relatively long and extend to a point near the top <NUM> of the bag <NUM>. In some examples, both degassing interface <NUM> as illustrated in <FIG> and degassing interface <NUM> as illustrated in <FIG> may be included within a single bag.

<FIG> is a flowchart illustrating a method <NUM> for degassing fluid before infusion into a patient's eye. According to the present example, the method includes a step <NUM> for connecting a fluid outflow port of a fluid storage container to a fluid infusion line. The fluid infusion line provides fluid communication between the fluid storage container and an ophthalmic surgical tool.

At a step <NUM>, the pressure inlet of the fluid storage container is connected to a pressure source. The pressure source is capable of applying both positive and negative pressure to the fluid storage container. Additionally, the pressure inlet includes a filter, such as a semipermeable membrane, that allows gas to pass therethrough but prevents liquid from flowing therethrough.

At a step <NUM>, the pressure source applies negative pressure to the pressure inlet. By applying negative pressure to the pressure inlet, gas within the chamber of the fluid storage container will exit the chamber through the membrane. Additionally, gas bubbles within the infusion fluid solution will exit the chamber. In other words, the infusion fluid solution is degassed. Through use of principles described herein, infusion fluid to be degassed before this injected into the patient's eye. This can help improve the visibility for the operator during a surgical procedure.

Claim 1:
A fluid delivery system (<NUM>) for providing pressurized fluid for infusion into a patient's eye, comprising:
a pressure source (<NUM>) capable of selectively producing positive and negative fluid pressure in a first fluid storage container and a second fluid storage container;
an infusion fluid source (<NUM>);
a fluid infusion line (<NUM>);
a first fluid storage container (<NUM>) comprising:
a first chamber (<NUM>);
a first fluid outflow port (<NUM>) in communication with the fluid infusion line to provide fluid communication between the first chamber and the fluid infusion line;
a first pressure inlet (<NUM>) in communication with the pressure source (<NUM>); and
a first filter (<NUM>) disposed between the first pressure inlet and the first chamber; and
a second fluid storage container (<NUM>) comprising:
a second chamber (<NUM>);
a second fluid outflow port (<NUM>) in communication with the fluid infusion line to provide fluid communication between the second chamber and the fluid infusion line;
a second pressure inlet (<NUM>) in communication with the pressure source (<NUM>); and
a second filter (<NUM>) disposed between the second pressure inlet (<NUM>) and the second chamber (<NUM>);
wherein the infusion fluid source (<NUM>) is in communication with the first and second fluid storage containers;
and
a control system (<NUM>) configured to fill the first fluid storage container (<NUM>) and the second fluid storage container (<NUM>) with infusion fluid from the infusion fluid source (<NUM>); and
the control system (<NUM>) configured to cause the pressure source to selectively apply negative pressure or positive pressure to the first chamber (<NUM>) and the second chamber (<NUM>) such that the negative pressure acts on the infusion fluid in one of the first and second chamber to degas the infusion fluid and the positive pressure acts to push the infusion fluid out of the other of the first or second chamber and into the fluid infusion line (<NUM>);
wherein the control system (<NUM>) is configured to apply positive pressure to the first fluid storage container (<NUM>) during a period of time, and during the period of time, sequentially cause the second fluid storage container (<NUM>) to be filled with infusion fluid and apply a negative pressure to the second fluid storage container (<NUM>).