Patent Description:
Age-Related Macular Degeneration (AMD) and diabetic retinopathy (DR) are the leading causes of blindness in the world, with an estimated projection of more than <NUM> million people affected by the year <NUM>. Currently, the standard of care for the treatment of AMD and DR includes monthly injections of Vascular Endothelial Growth Factor (VEGF) agents. Statistics from various eye healthcare centres in Singapore show that there are about <NUM>,<NUM> such injections per year.

However, there are problems associated with such injections. One problem may include ocular and systemic safety of such repeated injections over long periods of time, which are secondary to intraocular pressure (IOP) spikes (e.g. increase of 30mmHg). Another problem may include the inaccurate delivery of therapeutics due to reflux of vitreous material. Furthermore, there may also be no means of extracting intravitreal biomarkers, as current methods of extracting intravitreal biomarkers are merely proxies, i.e. having anatomical change (e.g. OCT) and functional change (e.g. vision). There are also problems when using typical injections, such as leak and reflux leading to Bleb formation, and damage to ocular structures.

It has also been noted that existing injection devices are not capable of extracting a sample from the eye, such that multiple punctures may be required for sample collection and drug delivery. The existing devices are also complicated and require trained doctors to operate, thus adding the cost of use to the drug cost.

<CIT> discloses an apparatus to treat a patient, which comprises a container to receive fluid of a device implanted in the eye. An injector is coupled to a double lumen needle such that the lumen needle injects therapeutic agent from a chamber of a first container into a device. A second container is coupled to a first lumen that extends to a chamber of a reservoir container and receives liquid from the device, such that liquid of the device is exchanged. A piston can be moved toward the device with a plunger, and a sliding component of a switching valve can be coupled to the plunger and the piston. When the piston has advanced to exchange an intended amount of liquid and an intended amount of the formulation of the therapeutic agent remains in first container, the sliding component of valve may cover and block the opening component of valve. With valve closed, an additional intended amount of therapeutic agent can be injected into the device, such that a bolus amount of therapeutic agent can be injected from device.

Accordingly, a need exists to provide a device and method that seeks to address some of the above problems.

According to the present invention, there is provided an extraction and injection ophthalmic device comprising: a housing comprising: an injection portion configured to receive an injection source; an extraction portion configured to receive an extraction source; a priming mechanism configured to simultaneously prime both the injection source and the extraction source; a needle selectively in fluid communication with the injection source or the extraction source; wherein on activation of the extraction source, the device is configured to extract a sample through the needle, and on activation of the injection source the device is configured to inject an agent through the needle.

The priming mechanism further comprises a lever communicatively coupled to a spring, such that a translation movement of the lever is configured to compress the spring to simultaneously prime both the injection source and the extraction source.

In an embodiment, the device may further comprise a manifold configured to selectively connect the needle with the injection source or the extraction source, wherein the manifold comprises a double spool manifold.

In an embodiment, the device may further comprise shearing means configured to shear excess vitreous humor from the sample to be extracted.

In an embodiment, the injection source and the extraction source may be removably attached to the housing.

In an embodiment, the injection source may include a syringe.

In an embodiment, the extraction source may include any one of: a syringe, a vacutainer or a pump.

In an embodiment, the device may further comprise an injection button configured to activate the injection source such that the injection portion is in fluid communication with the needle to inject the agent from the injection source to the needle.

In an embodiment, the device may further comprise an extraction button configured to activate the extraction source such that the extraction portion is in fluid communication with the needle to extract the sample from the needle to the extraction source.

In an embodiment, the extraction source may be fluidically separated from the injection source such that, in use, the agent does not contact the sample.

A method for ophthalmic extraction and injection comprises the steps of: attaching an injection source to an injection portion of an extraction and injection ophthalmic device; attaching an extraction source to an extraction portion of the extraction and injection ophthalmic device; priming, by a priming mechanism of the device, the injection source and the extraction source simultaneously; activating the extraction source to extract a sample through a needle, the needle being in fluid communication with the extraction source of the device, and activating the injection source to inject an agent through the needle, the needle being in fluid communication with the injection source of the device.

The method of using the extraction and injection ophthalmic device does not form part of the invention.

Priming the injection source and the extraction source simultaneously may comprise translating a lever communicatively coupled to a spring, such that the spring is compressed to simultaneously prime both the injection source and the extraction.

The method may further comprise shearing, by shearing means, excess vitreous humor from the sample to be extracted.

Activating the extraction source may comprise depressing an extraction button of the device to extract the sample.

Activating the injection source may comprise depressing an injection button of the device to inject the agent.

The method may further comprise fluidically separating the extracted sample from the injection source.

Furthermore, there is no intention to be bound by any theory presented in the preceding background of the invention or the following detailed description. Herein, devices and methods for ophthalmic extraction and injection are presented in accordance with present embodiments having the advantages of providing a safe and reliable way to extract vitreous and inject anti-VEGF agents in a single injection. In addition, it may also reduce intraocular pressure spikes, improve accuracy of drug delivery and prevent reflux of vitreous material which may lower the risk of damage to ocular structures.

<FIG> and <FIG> show perspective views of a device <NUM> for ophthalmic extraction and injection, according to an example embodiment. The device <NUM> includes a housing <NUM>, a needle <NUM>, a nozzle <NUM>, an injection button <NUM>, an extraction button <NUM> and a cover <NUM>. The housing <NUM> may include an injection portion, an extraction portion and a priming mechanism. A detailed view of the priming mechanism, the injection portion and the extraction portion are shown in <FIG> and will be explained in more detail below. The injection portion may be configured to receive an injection source <NUM> while the extraction portion may be configured to receive an extraction source <NUM>. In an embodiment, the injection portion may be adjacent to the extraction portion such that the injection source <NUM> and the extraction source <NUM> are positioned side-by-side. In an alternative embodiment, the injection portion may be above or below the extraction portion such that the injection source <NUM> and the extraction source <NUM> are positioned on top or below one another.

The needle <NUM> is selectively in fluid communication with the injection source <NUM> or the extraction source <NUM> when either the injection button <NUM> or the extraction button <NUM> is depressed. The injection source <NUM> may be a syringe which can contain an agent that is used to treat retinal disease. The injection portion, together with the injection source <NUM>, is in fluid communication with the needle <NUM> such that on activation of the injection source <NUM> when the injection button <NUM> is depressed, the device <NUM> is configured to inject the agent from the injection source <NUM> through the needle <NUM>.

The extraction source <NUM> may include any one of: a syringe, a vacutainer or a pump. The extraction portion, together with the extraction source <NUM>, is in fluid communication with the needle <NUM> such that on activation of the extraction source <NUM> when the extraction button <NUM> is depressed, the device <NUM> is configured to extract a sample through the needle <NUM> to the extraction source <NUM>. The extraction source <NUM> is also fluidically separated from the injection source <NUM> such that, in use, the agent in the injection source <NUM> does not contact the sample to be extracted. In this way, contamination of the extracted sample and the agent may be prevented which can advantageously result in providing a safe and reliable way to extract vitreous sample and inject anti-VEGF agents.

The priming mechanism includes a lever <NUM> and a spring <NUM> (as shown in <FIG>) such that the lever <NUM> is communicatively coupled to the spring and a translation movement of the lever <NUM> is configured to compress the spring to simultaneously prime both the injection source <NUM> and the extraction source <NUM>. The priming mechanism may also include a plurality of valves which are in communication with the injection source <NUM> and the extraction source <NUM> whereby the plurality of valves are closed to prevent contamination of the agent when the injection source <NUM> and the extraction source <NUM> are primed. The plurality of valves may include at least one duckbill valve.

The cover <NUM> may be pivotably mounted to the housing <NUM> such that the injection source <NUM> and the extraction source <NUM> can be attached or removed from the housing <NUM> when the cover <NUM> is in an open position. As shown in the Figures, the cover <NUM> is at a closed position after the injection source <NUM> and the extraction source <NUM> are attached to the housing <NUM>. The cover <NUM> may also include a tab which interacts with the injection button <NUM> and the extraction button <NUM> such that the plurality of valves in the priming mechanism are open when the cover <NUM> is at the open position.

<FIG> shows a perspective view of the device of <FIG> with the cover <NUM> opened, according to an example embodiment. In the Figure, the cover <NUM> is in the open position with the injection source <NUM> and the extraction source <NUM> attached to the housing <NUM>. At the open position, the injection source <NUM> and the extraction source <NUM> may also be removed from the housing <NUM>. <FIG> shows a cross-sectional side view of the device of <FIG>, according to an example embodiment. The device <NUM> as shown in the Figure has the cover <NUM> in a closed position and the needle <NUM> retracted into the housing <NUM>. The spring <NUM> of the priming mechanism is at an uncompressed position in the Figure as the injection source and the extraction source have yet to be attached to the housing <NUM>.

The nozzle <NUM> is arranged to receive the needle <NUM> so that the needle <NUM> can selectively protrude from the housing <NUM> when the priming mechanism is ready for priming. It can be appreciated that the needle <NUM> may retract into the housing <NUM> via the nozzle <NUM> when the agent from the injection source <NUM> has been delivered and the sample has been extracted into the extraction source <NUM>. The housing <NUM> may also include a cap (not shown) that is configured to cover the nozzle <NUM> and the needle <NUM> for safety reasons when the needle <NUM> is protruding from the housing <NUM> even though the device <NUM> is not in use.

The device <NUM> may include shearing means configured to shear excess vitreous humor from the sample to be extracted by the extraction source <NUM>. The shearing means may be part of the needle <NUM> or may be positioned aft of the needle <NUM> to shear the excess vitreous humor after the sample is extracted from the needle <NUM>.

<FIG> shows a perspective view of the priming mechanism <NUM> of the device of <FIG>, according to an example embodiment. As shown in the Figure, the priming mechanism <NUM> has a fitting 202a configured to receive the needle <NUM> and a collar 204a arranged to receive the fitting 202a. The priming mechanism <NUM> may also include a case 208a configured to receive the collar 204a, the injection button <NUM>, the extraction button <NUM>, the injection portion and the extraction portion.

In an embodiment, the priming mechanism <NUM> may include a first metal collar 206a that is configured to receive the injection portion and a second metal collar 206b configured to receive the extraction portion. The case 208a of the priming mechanism <NUM> is configured to receive the first and second metal collar 206a 206b. The fitting 202a of the priming mechanism <NUM> may be a metal luer fitting and the collar 204a may be a metal collar.

<FIG> shows a close up plan view of the priming mechanism of <FIG>, while <FIG> shows a plan view of the priming mechanism of <FIG>. In the Figures, the case 208a of the priming mechanism <NUM> is arranged to receive the collar 204a, the first metal collar 206a, the second metal collar 206b, the injection button <NUM> and the extraction button <NUM>.

<FIG> shows a perspective view of the priming mechanism of the device of <FIG>, according to an alternative embodiment. As shown in the Figure, the priming mechanism <NUM> has a fitting 202b configured to receive the needle <NUM> and a collar 204b arranged to receive the fitting 202b. The priming mechanism <NUM> may also include a case 208b configured to receive the collar 204b, the injection button <NUM>, the extraction button <NUM>, the injection portion and the extraction portion.

In an embodiment, the fitting 202b of the priming mechanism <NUM> may be a plastic luer fitting while collar 204b may be a plastic collar. The priming mechanism <NUM> may also include slip fit leurs built into the injection portion and the extraction portion which can eliminate the need for the first and second metal collars 206a, 206b of the priming mechanism <NUM>.

<FIG> shows a close up plan view of the priming mechanism of <FIG> while <FIG> shows a plan view of the priming mechanism of <FIG>. In the Figures, the case 208b of the priming mechanism <NUM> is arranged to receive the collar 204b, the injection portion <NUM>, the extraction portion <NUM>, the injection button <NUM> and the extraction button <NUM>. The case 208a of the priming mechanism <NUM> (<FIG>) is larger than the case 208b of the priming mechanism <NUM>. The case 208b directly receives the injection portion <NUM> and the extraction portion <NUM> while the case 208a receives the injection portion and the extraction portions <NUM>, <NUM> via the first metal collar 206a and the second metal collar 206b.

The distance between the injection button <NUM> and the extraction button <NUM> in priming mechanism <NUM> is more than the distance between the injection button <NUM> and the extraction button <NUM> in priming mechanism <NUM> (<FIG>). The positioning of the plurality of valves (not shown) in priming mechanism <NUM> may also be different from those of priming mechanism <NUM>. Each of the priming mechanisms <NUM>, <NUM> may also include a plurality of internal ports configured to allow fluid communication between the needle <NUM> and the injection portion <NUM> or the extraction portion <NUM>. By having a smaller case, having plastic fittings and slip fit luers, the priming mechanism <NUM> is smaller in size and weight as compared to priming mechanism <NUM>. This may result in a reduction in the length, width and height of the device <NUM> which may advantageously lead to better ergonomics and better usability of the device <NUM> as the patient may feel more comfortable having a smaller device as compared to a larger device.

<FIG> show cross-sectional functional views <NUM> of the priming mechanism of the device of <FIG>, according to an example embodiment. The priming mechanism may comprise a manifold of a double spool design having a low profile which may lead to a pen-styled grip design of the device <NUM>. Having a pen-styled grip design may be advantageous in providing a better hold or grip of the device <NUM> in order to achieve a better control while operating the device <NUM> close to the patient. In <FIG>, the priming mechanism is at a state when the injection source <NUM> and the extraction source <NUM> are yet to be attached to the housing <NUM>. The cover <NUM> of the housing <NUM> is at the open position and both the injection button <NUM> and the extraction button <NUM> are depressed. The plurality of valves (not shown) of the priming mechanism are open which may allow the needle <NUM> to be in communication with both the injection portion <NUM> and the extraction portion <NUM>.

After the injection source <NUM> and the extraction source <NUM> are disposed in the housing <NUM> and the cover <NUM> is closed, the lever <NUM> is pulled away from the needle which compresses the spring <NUM> and simultaneously primes the injection source <NUM> and the extraction source <NUM>. As shown in <FIG>, the injection button <NUM> and the extraction button <NUM> are at an elevated position so that the needle <NUM> is not in communication with both the injection portion <NUM> and the extraction portion <NUM>. At the same time, a vacuum is also created at the extraction portion <NUM>.

In <FIG>, the extraction button <NUM> is depressed to activate the extraction source <NUM>, thereby only allowing communication between the needle <NUM> and the extraction portion <NUM>. The vacuum previously created at the extraction portion <NUM> allows the extraction source <NUM> to extract the sample via the needle <NUM>. Subsequently, after the sample has been extracted, the injection button <NUM> is depressed to activate the injection source <NUM>. By depressing the injection button <NUM> after priming, the extraction button <NUM> returns to the elevated position as shown in <FIG>. This allows communication only between the needle <NUM> and the injection portion <NUM>. The agent contained in the injection source <NUM> is thus delivered to the patient via the needle <NUM>.

<FIG> show perspective views of a button cover <NUM> for the injection and extraction button of the device of <FIG>, according to an alternative embodiment. The button cover <NUM> may include a spring well <NUM> configured to house the spring <NUM> of the priming mechanism and a spool slot <NUM>. The button cover <NUM> in this embodiment may allow the injection button <NUM> and the extraction button <NUM> to adopt a front and back configuration, which can prevent the accidental depression of the injection button <NUM> or the extraction button <NUM>. It can also prevent arching of a user's fingers over the injection and extraction buttons <NUM>, <NUM> which may improve usability and ergonomics.

<FIG> shows a flow chart illustrating a method <NUM> for ophthalmic extraction and injection. The method comprises at step <NUM> attaching an injection source to an injection portion of an extraction and injection ophthalmic device. At step <NUM>, the method includes attaching an extraction source to an extraction portion of the extraction and injection ophthalmic device. At step <NUM>, the method includes priming, by a priming mechanism of the device, the injection source and the extraction source simultaneously. Priming the injection source and the extraction source simultaneously may include translating a lever communicatively coupled to a spring, such that the spring is compressed to simultaneously prime both the injection source and the extraction. At step <NUM>, the method includes activating the extraction source to extract a sample through a needle, the needle being in fluid communication with the extraction source of the device. At step <NUM>, the method includes activating the injection source to inject an agent through the needle, the needle being in fluid communication with the injection source of the device.

The method may further include shearing, by shearing means, excess vitreous humor from the sample to be extracted; activating the extraction source comprises depressing an extraction button of the device to extract the sample; and activating the injection source comprises depressing an injection button of the device to inject the agent.

The device and method for ophthalmic extraction and injection as described herein may be used to perform biopsy and injection simultaneously with only a single device. The injection and extraction sources may be disposable and compatible with standard therapeutics and syringe fittings. The device and method as disclosed may maintain intraocular pressure during injection of the agent and may have a low risk of retinal detachment during vitrectomy, i.e. extraction of the vitreous humor gel of a patient. The device and method may also result in little or no damage to the lens or retinal structures while having a clean extraction of vitreous humor. The device and method may also be used to monitor Vascular Endothelial Growth Factor levels from biopsy for patient-tailored therapy.

While exemplary embodiments have been presented in the foregoing detailed description of the invention, it should be appreciated that a vast number of variations exist.

It should further be appreciated that the exemplary embodiments are only examples, and are not intended to limit the scope, applicability, operation, or configuration of the invention in any way. Rather, the foregoing detailed description will provide those skilled in the art with a convenient road map for implementing an exemplary embodiment of the invention, it being understood that various changes may be made in the function and arrangement of elements and method of operation described in an exemplary embodiment without departing from the scope of the invention as set forth in the appended claims.

Claim 1:
An extraction and injection ophthalmic device (<NUM>) comprising:
a housing (<NUM>) comprising:
an injection portion configured to receive an injection source (<NUM>);
an extraction portion configured to receive an extraction source (<NUM>); and
a priming mechanism (<NUM>, <NUM>) configured to prime both the injection source (<NUM>) and the extraction source (<NUM>); and
a needle (<NUM>) selectively in fluid communication with the injection source (<NUM>) or the extraction source (<NUM>);
wherein on activation of the extraction source (<NUM>), the device (<NUM>) is configured to extract a sample through the needle (<NUM>), and on activation of the injection source (<NUM>), the device (<NUM>) is configured to inject an agent through the needle (<NUM>),
characterized in that the priming mechanism (<NUM>, <NUM>) comprises a lever (<NUM>) communicatively coupled to a spring (<NUM>), such that a translation movement of the lever (<NUM>) is configured to compress the spring (<NUM>) to simultaneously prime both the injection source (<NUM>) and the extraction source (<NUM>).