WIRELESS INJECTOR

The present disclosure generally relates to devices and methods for intraocular fluid delivery. Embodiments described herein provide improved mechanisms for precise delivery of therapeutic agents to intraocular tissues by utilizing a foot controller to wirelessly control a handheld injection device. The utilization of a remote foot controller to control the injection reduces or eliminates uneven application of injection force and hand tremor caused by hand-triggered devices, thus enabling precise position and flow rate control and reducing the risk of tissue damage.

BACKGROUND

Field

Embodiments of the present disclosure generally relate to methods and devices for ophthalmic procedures, and more particularly, to methods and devices for intraocular fluid delivery.

Description of the Related Art

Successful treatment of eye diseases and disorders depends not only on the effectiveness of therapeutic agents, but also on the effective administration thereof. Currently, the three primary methods of delivering therapeutic agents to the eye include systematic, topical, and intraocular administration. Compared to systematic and topical methods, intraocular administration offers the benefits of direct delivery of therapeutic agents and other fluids to target intraocular tissues at desired concentrations. Thus, intraocular drug delivery is frequently used in the treatment of many vitreoretinal diseases, including age-related macular degeneration (AMD), diabetic macular edema (DME), proliferative diabetic retinopathy, and retinopathy of prematurity (ROP), among others.

Typically, intraocular drug delivery requires controlled dispensing while maintaining precise position control in order to deliver a precise volume of fluid to a precise location within the eye without causing damage thereto. Controlled dispensation of the drug while maintaining precise position control may also be important when delivering expensive therapeutic agents, such as retinal gene therapies, so that as little of the therapeutic agent as possible is delivered off-target and wasted. However, conventional hand-operated injection devices present a number of challenges to a user (e.g., physician) when delivering fluids to intraocular tissues, which can result in imprecise drug delivery and/or damage to ocular tissues.

Injection devices typically include a syringe and a needle and fall into one of two categories—manual injection devices and automatic injection devices. With a manual injection device, a user must provide the mechanical force to drive the fluid through the device and into the eye, such as by pressing against a plunger during the injection. Typically, the user utilizes the same hand to control the position of the injection device and the flow rate of the fluid therethrough. As a result, the user may not be able to precisely control the flow rate or amount of injection, particularly if injection forces are too high for the user and/or if the plunger is extended too far. The combination of injection forces and extension of the plunger may cause shaking of the user's hand, which in turn may result in imprecise drug delivery and/or damage to ocular tissues.

Automatic injection devices overcome some of the challenges presented by manual injection devices by providing an automated mechanism to drive the fluid through the device. However, conventional automatic injection devices require hand-operated triggering by the user in order to activate the automated fluid-driving mechanism, which may cause undesired jerking of the device. During intraocular drug delivery, the uneven forces and tremors from the user's hand when activating the fluid-driving mechanism may be magnified in the eye and cause damage thereto, and further reduce injection control.

Accordingly, what is needed in the art are improved methods and devices for intraocular fluid delivery.

SUMMARY

The present disclosure generally relates to methods and devices for intraocular fluid delivery.

In one embodiment, a handheld fluid injection device includes a handpiece having an interior compartment and a distal port configured to receive and engage a syringe, a plunger movably disposed within the interior compartment and having a distal end configured to slidably engage with a cavity of the syringe, and a drive unit operatively coupled to the plunger. The drive unit further includes a wireless communication module that is in wireless communication with an input device that enables the drive unit to control operations of the plunger based on wireless communication received from the input device for injection of fluids from the syringe.

DETAILED DESCRIPTION

The present disclosure generally relates to devices for intraocular fluid delivery. As just one example, the instruments described herein may be used for sub-retinal injection of therapeutic agents, such as gene therapies for ocular disease. However, the instruments described herein may be used in connection with any other intraocular fluid deliveries, as one of ordinary skill in the art appreciates.

Intraocular drug delivery may be used for the treatment of vitreoretinal disease due to the benefit of direct delivery into the vitreous, retina, and other ocular tissues. However, hand-delivered intraocular injections require great skill and precision due to the size and structure of the eye, and can become problematic from application of uneven forces or tremors from a surgeon's hands, which may result in damage to the patient's eye. Adverse events may also arise from a surgeon not being able to precisely control the flow rate or amount of fluid being injected through a hand-operated device, thus creating further delays and difficulties during ophthalmic procedures. The devices and methods described herein provide improved mechanisms for precise delivery of therapeutic agents to intraocular tissues by utilizing a foot controller to wirelessly control a handheld injection device. The utilization of a remote foot controller to control the injection reduces or eliminates uneven application of injection force and hand tremor caused by hand-triggered devices, thus enabling precise position and flow rate control and reducing the risk of tissue damage.

FIG. 1illustrates a perspective view of an exemplary foot controller100, in accordance with certain embodiments of the present disclosure. The foot controller100includes a body102with a base104that supports the foot controller100on an operating room floor. The body102further includes a footpedal106, which is configured to be actuated by a user to perform one or more actions of a surgical procedure, such as injecting fluid from a handheld injection device (e.g., shown inFIGS. 3 and 4). For example, a surgeon depresses the footpedal106using the distal portion of his or her foot to move from a fully undepressed position to, for example, a fully depressed position in which the footpedal106lies in generally the same plane as a heel rest108. Accordingly, proportional depression of the footpedal106is utilized for proportional control of fluid injection with the injection device, where the position of the footpedal106(e.g., the extent to which the footpedal106is depressed) corresponds to a desired flow rate of the injection device.

As discussed in more detail below, the foot controller100is useful as an integrated primary control foot controller when physically or wirelessly coupled to a surgical console and/or injection device. In certain embodiments, the foot controller100is wirelessly in direct communication with an injection device. In certain other embodiments, the foot controller100is physically or wirelessly coupled to a surgical console, which is in wireless communication with an injection device.

FIG. 2illustrates a perspective view of an exemplary surgical system200including a surgical console201, which is operably coupled, physically or wirelessly, to any number of user interfaces, including the foot controller100, in accordance with certain embodiments of the present disclosure. The surgical console201allows a user, generally a surgeon or other medical professional, to select ophthalmic procedures and set operating parameters and modes for such processors into the surgical console201, for example by using an electronic display screen202(e.g., via a touch-screen interface, mouse, trackball, keyboard, etc.), which displays a graphical user interface (GUI)204. The electronic display screen202allows the user to access various menus and screens related to the functions and operations of the surgical console201. For example, the surgeon may select a fluid delivery operation during which a handheld injection device (e.g., shown inFIGS. 3 and 4) is used to deliver fluid to intraocular tissues of the patient. As described in further detail below, in certain embodiments, surgical system200is configured to wirelessly control the operations of the injection device based on commands received from the surgeon through the foot controller100.

After a fluid delivery operation or mode is selected on the surgical console201, the surgeon can control injection with the injection device by depressing the footpedal106. In certain embodiments, control or command signals corresponding to the position (e.g., angle or displacement) of the footpedal106or the amount of pressure applied thereto are transmitted from the foot controller100to the surgical console201and then relayed by the surgical console201to the injection device to perform injection. The surgeon controls the injection flow rate of the injection device based on the position of the footpedal106such that the further the footpedal106is depressed, the faster the fluid in the injection device is dispensed. In certain embodiments, during the injection, the injection device wirelessly communicates with the surgical console201and provides injection information (e.g., flow rate, fluid volume remaining or dispensed) in graphics or text to display on a display screen for the surgeon, such as electronic display screen202of the surgical console201. In certain embodiments, the injection information is provided to and displayed on a display device separate from the surgical console201, such as a display device of a high-definition visualization system. For example, the injection information is displayed on a three-dimensional (3D) organic light-emitting diode (OLED) display screen of a stereoscopic microscope workstation, which may be observed by the user through passive, polarized 3D glasses.

In certain embodiments, control or command signals from the foot controller100are directly transmitted to the handheld injection device to perform injection. In other words, in such embodiments, the control signals do not pass through the surgical console201.

FIG. 3illustrates a cross-sectional side view of a handheld injection device300. The injection device300may wirelessly communicate with and receive commands from the foot controller100and/or surgical system200, in accordance with certain embodiments of the present disclosure. For example, the injection device300is wirelessly coupled to the foot controller100and/or surgical system200to enable remote injection control, such as by operation of the foot controller100, thus reducing or eliminating the uneven forces and tremors from the user's hand during the injection. Note that injection device300may be controlled by any other type of user interfaces. For example, the surgeon may trigger injection, select and change the injection flow rate, and generally operate the injection device300in other similar ways by communicating with the surgical console201through a graphical user interface204or other user interfaces (e.g. voice commands, other user interface devices, etc.).

The injection device300includes a handpiece302, an electro-pneumatic drive unit340, and a syringe or similar device312attached to the handpiece302and operably coupled to the drive unit340. The injection device300is an automatic injection device with the drive unit340providing force or power to deliver an injection fluid322contained within the syringe312. The injection fluid322may include one or more agents or materials (e.g., therapeutic agents or materials) to be delivered to intraocular tissues of a patient, for example, in solution or suspension form.

The handpiece302houses the drive unit340and the syringe312and may include one or more divided interior compartments therein. A distal end304of the handpiece302includes a port306to receive and engage the syringe312while a proximal end308of the handpiece302is enclosed by a removable cap310, thus enabling access to the drive unit340if desired. Note that, as described herein, a distal end or portion of a component refers to the end or the portion that is closer to a patient's body during use thereof. On the other hand, a proximal end or portion of the component refers to the end or the portion that is distanced further away from the patient's body. The handpiece302may be formed as a single, integral component, or from multiple separate components permanently or removably coupled together. The handpiece302is formed of any suitable material, and is formed by any method, such as for example, injection molding or machining. In certain embodiments, the handpiece302is formed of a thermoplastic or metal and may be textured or contoured for improved gripping thereof by the user.

The syringe312includes a syringe barrel314having a cavity320at least partially defining a volume (e.g., reservoir) for injection fluid322. A proximal end324of the syringe barrel314is open to slidably receive a stopper334coupled to a distal end of a plunger rod332. In certain embodiments, the plunger rod332and stopper334may together be referred to as a plunger333. In certain embodiments, the stopper334is a component of the syringe312and only engages with the plunger rod332upon insertion of the syringe312into the handpiece302. A needle328extends from a distal end of the syringe barrel314for piercing of ocular tissues and delivery of the injection fluid322when the plunger333is linearly actuated. In certain embodiments, the syringe312is a pre-filled syringe having a predetermined volume of injection fluid322that is engaged with the handpiece302after filling. In certain other embodiments, the syringe312is filled after engagement with the handpiece302. For example, the syringe312may be filled with injection fluid322by injection through a port or septum disposed through the handpiece302. The syringe312may be removably or integrally attached to the handpiece302by any suitable mechanism. In certain embodiments, one or more mating features330such as flanges, grooves, or threads are formed on an outer surface of the syringe312to engage with and secure the syringe312to the handpiece302. Similar to the handpiece302, the syringe312is formed of any suitable material, and is formed by any method, such as for example, injection molding or machining.

The plunger rod332extends through an intermediate compartment336of the handpiece302and engages the stopper334at a distal end thereof. Linear movement of the plunger rod332through the intermediate compartment336causes linear actuation of the stopper334through the cavity320to direct the injection fluid322through the needle328. For example, forward movement (e.g., from a proximal position to a distal position) of the plunger rod332forces the stopper334to distally move through the cavity320and push injection fluid322therefrom. In certain embodiments, the stopper334is formed of a suitable elastomeric material that enables slidable engagement of the stopper334with an interior surface of the cavity320while forming a fluid-tight seal. In certain other embodiments, the stopper334includes one or more seals to establish a fluid-tight seal for the cavity320.

In embodiments where the drive unit340is an electro-pneumatic drive unit utilizing pressurized gas, such as inFIG. 3, the plunger333includes a flange338disposed at a proximal end of the plunger rod332that forms an interface between the plunger333and the drive unit340. The flange338acts as a seal or plug upon which gas pressure may apply a force to cause actuation thereof. Accordingly, the flange338is slidably engaged with an interior surface of the intermediate compartment336and forms a fluid-tight seal therein. The flange338is therefore formed of a suitable elastomeric material or includes one or more seals at a perimeter thereof.

The drive unit340generally includes an actuator342, wireless communication module344, and a battery346to supply power to the actuator342and wireless communication module344. The electro-pneumatic drive unit340depicted inFIG. 3further includes a valve348and gas canister350containing a pressurized fluid. Examples of suitable pressurized fluids include but are not limited to carbon dioxide, nitrogen, and argon. The gas canister350removably couples to a proximal end of the handpiece302below the cap310by any suitable coupling mechanism or feature, such as for example, matching threads. Upon securing the gas canister350to the handpiece302, pressurized fluid within the gas canister350is released (e.g., by puncturing a seal of the gas canister350) into a septum352, which is sealed by the valve348.

The valve348is opened and closed by the actuator342to control the flow rate of the pressurized fluid through the septum352and into a pressurization pocket354on a proximal side of the flange338. In a closed state, the valve348prevents any flow of fluid into the pressurization pocket354. When the valve348is opened, the pressurized fluid is allowed to flow into the pressurization pocket354at a controlled flow rate depending on the position of the valve348. As described above, the accumulation of pressurized gas in the pressurization pocket354applies a force to the proximal side of the flange338, thereby causing forward (e.g., distal) movement of the plunger333to dispense the injection fluid322from the syringe312. The valve348includes any suitable type of flow control valve operated by an electromechanical, electromagnetic or electro-pneumatic actuator342. Suitable valves include, but are not limited to, solenoid-type valves, proportional valves, plug valves, piston valves, knife valves, or the like.

The actuator342is operably coupled to the wireless communication module344which includes wireless transmitter and receiver circuitry to relay signals (e.g., instructions) to and from the injection device300. In particular, the wireless communication module344is directly or indirectly in wireless communication with the foot controller100to enable remote control of the injection device300with the foot controller100. In certain embodiments, the wireless communication module344is indirectly in communication with the foot controller100via the surgical console201, which may relay control signals from the foot controller100to the wireless communication module344. In certain other embodiments, the wireless communication module344is directly in communication with the foot controller100, thus receiving control signals directly therefrom. Upon receiving a signal from foot controller100or surgical console201, wireless communication module344transmits a signal to actuator342to open or close valve348. In certain embodiments, one or more interfaces may be used between wireless communication module344and actuator342(e.g., a digital to analogue converter, a driver circuit, etc.).

In operation, the user activates and controls actuation of the actuator342by operation of the foot controller100, thus controlling the position of the valve348and the flow rate of pressurized gas through the septum352. For example, the user may depress the footpedal106to open the valve348and increase the flow rate of the pressurized gas into the pressurization pocket354, thereby increasing the force applied to the flange338and causing forward movement thereof. Alternatively, reducing depression of the footpedal106(e.g., raising a user's foot or pressing down on the footpedal106with the user's heel) may decrease the flow rate of the pressurized gas into the pressurization pocket354, thereby slowing the movement of the flange338. Applying no pressure to the footpedal106causes the footpedal106to transition into a fully undepressed state and, thereby, completely stop the flow of pressurized gas through the septum352altogether, and in turn, stop movement of the plunger333. In certain embodiments, the flow rate of the pressurized gas into the pressurization pocket354may linearly correspond to the position of the footpedal106. Accordingly, the injection flow rate of the injection device300may linearly correspond to the position of the footpedal106. For example, a fully depressed state of the footpedal106corresponds with a maximum injection flow rate, while the fully undepressed state of the footpedal106corresponds with no injection flow.

In certain embodiments, information about the injection (e.g., flow rate and fluid volume dispensed or remaining) may be transmitted from the wireless communication module344to the surgical console201and displayed on the electronic display screen202while a user is performing the injection. In certain embodiments, information about the injection may be wirelessly transmitted from the wireless communication module344and/or surgical console201to a digital 2D or 3D surgical viewing system or display panel, or a 3D headset.

FIG. 4illustrates a cross-sectional side view of an alternative injection device400including an electromechanical drive unit440. Similar to the injection device300, the injection device400may be configured to wirelessly communicate with and receive commands from the foot controller100and/or surgical system200, in accordance with certain embodiments of this disclosure. For example, the injection device400is wirelessly coupled to the foot controller100and/or surgical system200to enable remote injection control, thus reducing or eliminating the uneven forces and tremors from the user's hand during the injection. Note that injection device400may be controlled by any other type of user interfaces. For example, the surgeon may trigger injection, select and change the injection flow rate, and generally operate the injection device400in other similar ways by communicating with the surgical console201through a graphical user interface204or other user interfaces (e.g. voice commands, other user interface devices, etc.).

The drive unit440includes an actuator442, wireless communication module344, and a battery346to supply power to the actuator442and wireless communication module344. The drive unit440is an electromechanical drive unit and thus, utilizes electrical input to the actuator442to create mechanical force on a plunger433having a flange438, plunger rod432, and stopper434. The actuator442, such as a rotary actuator, is mechanically engaged with an elongated drive device456which translates movement of the actuator442, such as rotational movement, into linear movement of the plunger433. The actuator442is further in communication with the wireless communication module344. In certain embodiments, one or more interfaces may be used between wireless communication module344and the actuator442(e.g., a digital to analogue converter, a driver circuit, etc.). Upon receiving signals from the foot controller100or surgical console201, the wireless communication module344transmits a signal to the actuator442to actuate the elongated drive device456. The elongated drive device456may be any suitable type of drive device, including but not limited to a drive screw, a rack engaged with a pinion, or the like. InFIG. 4, the elongated drive device456is depicted as a drive screw mated with the actuator442and the flange438. As shown, the flange438forms an interface between the plunger433and the drive unit440.

In operation, the user may activate and control the actuator442by operation of the foot controller100, thus controlling movement of the elongated drive device456. For example, the user may depress the footpedal106to rotate or linearly actuate the elongated drive device456in an injection direction and cause forward (e.g., distal) movement of the plunger433, thereby forcing the injection fluid322out of the syringe312. Alternatively, reducing depression of the footpedal106may slow the movement of elongated drive device456in the injection direction, thereby slowing movement of the plunger433. Applying no pressure to the footpedal106causes the footpedal106to transition into a fully undepressed state and, thereby, completely stop the movement of the elongated drive device456altogether, and in turn, stop movement of the plunger433. In certain embodiments, the movement speed of the elongated drive device456may linearly correspond to the position of the footpedal106. Accordingly, the injection flow rate of the injection device400may linearly correspond to the position of the footpedal106. For example, a fully depressed state of the footpedal106corresponds with a maximum injection flow rate, while the fully undepressed state of the footpedal106corresponds with no injection flow.

In certain embodiments, the user may also control the plunger433to move in a reverse (e.g., proximal) direction, thus enabling the injection device400to draw up fluid into the syringe312for loading (e.g., filling) thereof. For example, the user may depress a switch on the foot controller100to activate a reverse mode of the injection device400, wherein subsequent depression of the footpedal106actuates the elongated drive device456in a direction opposite the injection direction. The reverse mode may include the same mechanics as described above, wherein the reverse movement speed of the elongated drive device456linearly corresponds to the position of the footpedal106.

FIG. 5illustrates an exemplary diagram showing how various components of an injection device500(e.g., injection devices300,400), surgical system200, and foot controller100communicate and operate together. Foot controller100contains a mechanical input device510, such as footpedal106, which receives a mechanical input from a user and provides a control signal to signal converter512. The control signal may include a measurement of the mechanical input device510's position (e.g., in terms of angle or displacement), which is converted into a digital signal for relaying to surgical system200and/or injection device500. Where the foot controller100is a wireless device, the digital signal is wirelessly relayed to surgical system200and/or directly to the injection device500via wireless interface514. Where the foot controller100is wired, the digital signal is relayed to surgical system200via interconnect516and then wirelessly relayed to injection device500via wireless interface518of the surgical console201.

The surgical console201includes a processor or central processing unit (CPU)501, memory502, and support circuits. CPU501may retrieve and execute programming instructions stored in the memory502. Similarly, CPU501may retrieve and store application data residing in memory502. CPU501can represent a single CPU, multiple CPUs, a single CPU having multiple processing cores, and the like.

Memory502may be one or more of a readily available memory, such as random access memory (RAM), read only memory (ROM), floppy disk, hard disk, solid state, flash memory, magnetic memory, or any other form of digital storage, local or remote. In certain embodiments, memory502includes instructions, which when executed by the CPU501, performs an operation for controlling fluid delivery, as described in the embodiments herein. For example, memory502includes instructions that determine that the user selected an injection mode, thereby the instructions instruct the CPU501, when executed, to activate the foot controller100or allow the foot controller100to receive commands (e.g., input) from the user. Memory502also has instructions that, when executed by the CPU501, cause the surgical console201to control the flow rate and other operations of the injection device500based on the input received form the foot controller100(e.g., input corresponding to the position of the footpedal106or amount of pressure applied thereto).

As depicted inFIG. 5, wireless communication pathways are operably established between the injection device500and foot controller100and/or surgical system200via wireless interface520(e.g., wireless communication module344). Specifically, wireless interface520communicatively couples to the wireless interface514of the foot controller100and/or wireless interface518of the surgical console201. Each wireless interface may be implemented, for example, using low-power wireless transmitter and receiver circuitry. Thus, the control signal provided by the mechanical input device510is able to be converted into a digital signal and ultimately communicated to injection device500via wireless pathways. Upon receipt of the digital signal by wireless interface520, the digital signal is converted by the signal converter522to a control signal and relayed to the mechanical output device524, such as actuator342or442, to control fluid injection parameters, such as flow rate, by the injection device500.

In summary, embodiments of the present disclosure include structures and mechanisms for improved intraocular fluid delivery, and in particular, improved handheld injection devices for delivering therapeutic agents to intraocular tissues. The injection devices described above include embodiments wherein a user, such as a surgeon, may wirelessly control operation of the injection device via operation of a remote foot controller. The utilization of wireless remote injection control reduces or eliminates uneven application of injection force and hand tremor caused by hand-triggered devices, thus enabling precise position and flow rate control and reducing the risk of tissue damage. Accordingly, the aforementioned injection devices are particularly beneficial during injections of thin and delicate ocular tissues, such as the sub-retinal space.