Patent Description:
The subject matter described herein relates to an implant container that can contain an ocular implant and assist with loading the ocular implant onto an implant delivery tool.

During implantation of some ocular implants, a delivery tool is used for guiding the ocular implant to a desired implantation site. The delivery tool may be comprised of any number of mechanisms for securing or holding the ocular implant during the surgical procedure. For example, some delivery tools have a guidewire that extends through a lumen of an implant and constrains the implant, which can enable the user to guide the implant to the implantation site. The guidewire may include additional retention features for securing the implant onto the guidewire, such as frictional features or the like. In other delivery devices, a sheath or cover over the implant may be used for constraining the implant. Other delivery devices may use a gripping mechanism to hold a distal edge or any other section of the implant during the procedure.

An important step of the surgical procedure can be connecting the implant to a holding mechanism of the delivery tool. For example, in the case of a guidewire holding mechanism, the implant lumen is relatively aligned with the guidewire such that the guidewire can be inserted into the lumen of the implant. The implant can be manually held in a position that maintains this relative alignment during the loading. In other holding mechanisms, similar requirements exist.

The user may hold the implant with their hand and insert it onto the guidewire, but this presents several challenges. Ocular implants are generally small and the lumen and associated guidewire are also small so the features may be difficult to see clearly and to handle manually. If the necessary features are not properly aligned the guidewire may damage the implant, such as near the lumen, causing a device defect or failure.

Alternatively, the manufacturer may supply to the user the delivery tool with the implant already loaded. However, this may have a negative impact on the implant or the delivery tool depending on certain factors. For example, the implant may be made of materials that can be altered or damaged during continuous contact with the guidewire or other parts of the delivery tool. For example, during sterilization cycles or shipping the implant may be subjected to forces or loads by the delivery tool that are unwanted and cause a change in the implant.

Patent specification <CIT> describes an injection device for intraocular delivery of materials from a container. Patent specification <CIT> describes an ophthalmic surgical apparatus and method for preloading an intraocular lens in a component of an injector device. International patent application <CIT> describes devices, systems, and methods for delivering an intraocular lens into an eye, and more particularly a lens case for storing an intraocular lens.

The scope is in accordance with the appended claims.

Described herein is an implant container for positioning an ocular implant relative to a delivery feature of an implant delivery device and assisting loading the ocular implant onto the delivery feature. Such positioning provided by the container device improves loading of the ocular implant onto the delivery feature by preventing misalignment of the implant during loading. This can improve the efficiency of a procedure and reduce or eliminate damage to the implant. For example, if the implant is misaligned with the delivery feature during loading, the delivery feature can damage (e.g., puncture, tear) the implant. Furthermore, since the size of ocular implants are small and difficult to load onto a delivery device, the implant container provides an efficient and safe way to load an ocular implant onto a delivery device, thus saving time and money during a procedure.

Various embodiments of an implant container are described herein that can be coupled to (including integrated with) a delivery tool while also not requiring any positioning of the implant by the user prior to loading the implant. Some embodiments of an implant container can be similar to a pen cap that is held on the end of a delivery tool for properly constraining and aligning the implant during the loading procedure.

Many ophthalmic implants are small (on the order of millimeters) and difficult to handle manually. Such ophthalmic implants can require loading of the implant onto a delivery tool, a method whereby a user can manually place the implant onto a separate accessory device that is used for placing the implant at time of surgery. An approach to implant loading that requires minimal amount of user handling and potential for implant damage or misuse (i.e. placing backwards, placing debris on implant, etc.) can reduce surgery time, streamline procedures, and minimize implant loading related complications. An implant container, whereby an implant is positioned and aligned relative to a delivery device such that loading may be done with minimal operator handling is one approach that makes use of such benefits.

<FIG> shows a delivery tool <NUM> with an implant <NUM> loaded on a guidewire <NUM> extending from a distal end of the delivery tool <NUM>. <FIG> shows the distal end of the delivery tool <NUM> of <FIG> in greater detail. The implant <NUM> is loaded onto the guidewire <NUM> and abutted against a hypotube <NUM>. In this example, the guidewire <NUM> extends beyond the distal end of the implant <NUM>, however, any length of guidewire <NUM> may be considered for the inventive device described herein.

In <FIG>, an embodiment of an implant container <NUM> is shown coupled to the distal end of the delivery tool <NUM>. The implant container <NUM> can releasably secure the implant <NUM> in a position such that a lumen of the implant is aligned with a delivery feature (e.g., hypotube <NUM> and/or guidewire <NUM>) of the delivery tool <NUM>. The implant container <NUM> in this embodiment is similar to a pen cap that is integrated onto the end of the delivery device <NUM>. The implant container <NUM> provides several functions such as holding the implant <NUM> in the correct orientation and alignment during the loading procedure (e.g., loading the implant <NUM> onto the guidewire <NUM> extending from the distal end of the delivery tool <NUM>). The implant container <NUM> may also protect the implant <NUM> during shipping, surgical preparation, and user interaction before the loading procedure begins.

In <FIG>, the implant container <NUM> of <FIG> is shown. The implant container <NUM> has an implant housing <NUM> that constrains the implant <NUM>. The implant housing <NUM> is slightly smaller than the implant <NUM> in one or more dimensions to provide a friction fit. According to the present invention, the implant housing <NUM> includes a chamber enclosed within a housing of the implant container <NUM> and in communication with a delivery passageway <NUM> that extends between the chamber and a proximal end of the container housing. The delivery passageway <NUM> is sized to allow the delivery feature of the implant device with the implant loaded thereon to travel along the delivery passageway <NUM> to exit the implant container <NUM> when the implant container <NUM> is decoupled from the delivery device <NUM>. In some embodiments, the implant container <NUM> may simply have a single feature that holds the implant <NUM>, such as a loop or a spring clip, and the rest of the implant <NUM> may not be surrounded by material.

The implant container <NUM> contains features that interface with the delivery device <NUM>. The delivery passageway <NUM> assists assist with securing alignment between the delivery feature that includes an hypotube and the implant <NUM>. The hypotube <NUM> and the delivery passageway <NUM> have a cylindrical cross-section and the delivery passageway <NUM> provides a sliding fit with the hypotube thereby axially constrain the implant container <NUM> to the delivery device <NUM> when the hypotube <NUM> extends along the delivery passageway <NUM>. Additionally, features may be added to the hypotube <NUM> that further allow for alignment and orientation of the implant container <NUM> relative to the delivery device <NUM>. For example, cut features on the hypotube <NUM> or bosses extending out of the hypotube <NUM> may be used for alignment of the implant container <NUM> to the delivery device <NUM>.

In some embodiments, the implant container <NUM> can interface with a handle component of the delivery device <NUM>. The implant container <NUM> may have a feature such as a conical hole <NUM> that aligns with a conical feature <NUM> (see, for example, <FIG>) on the handle, which properly aligns and locates the implant container <NUM> relative to the delivery device <NUM>. Any number of other features or components may be contemplated for interfacing the delivery tool <NUM> to the implant container <NUM>.

In some embodiments, the implant container <NUM> can be securely held onto the distal end of the delivery device <NUM> like a pen cap. In this embodiment, the implant container <NUM> may contain one or more coupling features that releasably couple the implant container <NUM> to the delivery device <NUM>. In <FIG>, the implant container <NUM> includes a pair of retention arms <NUM> that extend from a proximal end of the implant container <NUM> and are configured to engage with one or more coupling features <NUM> (e.g., groove, recess) on the delivery device <NUM> (see, for example, <FIG>). The retention arms <NUM> may include cam surfaces <NUM> (see, for example, <FIG>) that can be decoupled from the coupling feature <NUM> at the end of the loading procedure. Such decoupling can be caused by a feature associated with the delivery device <NUM> in order to eject the implant container <NUM> off the delivery device <NUM> after loading of the implant <NUM> onto the delivery feature of the delivery device <NUM>. The implant container <NUM> may include a spring housing <NUM> that holds a spring that can be pressed against the front surface of the delivery tool <NUM> such that when the retention arms <NUM> are cammed out or decoupled from the delivery device <NUM>, the implant container <NUM> is ejected off of the delivery device <NUM>. In other embodiments, other force mechanisms such as elastic deformation of the retention arms <NUM> may be used for ejecting the implant container <NUM>.

In other embodiments, the implant container <NUM> may not include or require retention features for holding the implant container <NUM> against the delivery tool <NUM>. The implant container <NUM> can include alignment features to allow the user to properly align the implant <NUM> and the delivery tool <NUM> before beginning the loading procedure.

The implant container <NUM> may be manufactured from translucent or opaque plastics (i.e. polycarbonate, ABS, polypropylene, etc.), metals (i.e. stainless steel, titanium, etc.), or other equivalent materials. The use of translucent plastics may allow the user to see the implant <NUM> in the implant housing <NUM>, including during the loading procedure. Alternatively, one or more windows <NUM> may be included in the implant container <NUM> to allow the user to see the implant <NUM>, such as during the loading procedure. In still other embodiments, the translucent plastic may be configured in such a way to magnify or enlarge an image of the implant during the loading procedure to make certain areas and features more visible.

In some implementations, the implant container <NUM> consists of a single part comprised of injection molded plastic. In other embodiments, the implant container <NUM> may be comprised of any number of components secured together as an assembly. Furthermore, the components may be stationary relative to one another or move relative to one another such as telescoping components or features.

Turning now to <FIG>, a loading procedure with a delivery tool <NUM> is shown. In <FIG>, a top view of a delivery tool <NUM> is shown with a loading button <NUM> at the proximal end and a hypotube <NUM> at the distal end. The delivery tool <NUM> can include a variety of handle components. In <FIG>, the distal end of the delivery tool <NUM> is shown in greater detail. The hypotube <NUM> may include a lumen that allows a guidewire to extend therethrough. As discussed in greater detail below, the guidewire can extend out of the hypotube <NUM> and retract into the hypotube <NUM>.

In <FIG>, an implant <NUM> is shown in relation to the delivery tool <NUM>. The lumen of the implant <NUM> is generally aligned with the axis of the hypotube <NUM> and when the guidewire <NUM> is extended it will enter the lumen of the implant <NUM> thereby loading the implant <NUM> onto the delivery tool <NUM>. One of the functions of the container device <NUM> described herein is to align the implant <NUM> with the delivery tool <NUM>, such as with a delivery feature (e.g., hypotube <NUM>, guidewire <NUM>) of the delivery tool <NUM>, and reduce the amount of user input required to align and load the implant <NUM>.

In <FIG>, the guidewire <NUM> is extended through the lumen in the implant <NUM> and shown from a top view. As discussed above, any number of other holding mechanisms may be contemplated for securing the implant <NUM> to the delivery device <NUM>. In <FIG>, the delivery tool <NUM> and implant <NUM> are shown from a side view. The guidewire <NUM> may have a curve or bend that causes the implant <NUM> to curve or bend. Alternatively, the implant <NUM> may have a curve or bend that causes the guidewire <NUM> to curve or bend.

In <FIG>, the implant container <NUM> is shown coupled to the delivery tool <NUM> during the loading procedure. The proximal end of the implant container <NUM> can be releasably coupled to the distal end of the delivery tool <NUM>, as shown in <FIG>.

In <FIG>, the implant container <NUM> is shown in greater detail with half of the handle of the delivery tool <NUM> removed thereby showing one of the retention arms <NUM> extending along the delivery device <NUM>. The retention arms <NUM> are shown and can engage with a feature on the handle thereby securely mating the implant container <NUM> to the delivery tool <NUM>, including during shipping and loading. An internal component shown is a piston <NUM>. The piston <NUM> may be connected to other components such as the guidewire <NUM> such that by sliding the piston <NUM> distally, the guidewire <NUM> extends from the hypotube <NUM> and the implant <NUM> is loaded onto the guidewire <NUM>. In such an embodiment, the piston <NUM> can be translated by pressing the loading button <NUM> on the proximal end of the delivery tool. As the loading button <NUM> is depressed, the piston <NUM> translates distally and the guidewire <NUM> is extended distally (e.g., toward the implant <NUM>). As shown in <FIG>, the piston <NUM> may include piston cam arms <NUM> at the distal end that are configured to engage with the retention arms <NUM>. As the piston cam arms <NUM> translate distally they can release the coupling between the retention arms <NUM> and the securing feature <NUM> thus allowing the implant container <NUM> to be ejected or removed from the delivery tool <NUM>. In such an embodiment, the timing of the loading and the ejection of the implant container <NUM> may be timed such that ejection occurs after the loading of the implant <NUM> onto the guidewire <NUM>. The user presses the loading button <NUM> and the implant <NUM> is loaded onto the guidewire <NUM> and the implant container <NUM> is actively or passively removed from the delivery tool <NUM>.

In <FIG>, a section view of the implant container <NUM> is shown. In <FIG>, a more detailed view of the implant <NUM> within the chamber or implant housing <NUM> of the implant container <NUM> is shown. The implant housing <NUM>, as well coupling and alignment features associated with the housing of the implant container <NUM>, holds the implant concentrically with the hypotube and the guidewire. The guidewire in <FIG> is shown retracted within the lumen of the hypotube. The implant <NUM> in <FIG> is constrained in the implant housing <NUM> such that the lumen of the implant <NUM> is coaxially aligned with the guidewire <NUM> and/or hypotube <NUM>. The implant <NUM> may be under no stress in this configuration or may be held in place with any sufficient amount of force.

In <FIG>, the guidewire <NUM> is shown extended through the lumen of the implant <NUM>. The guidewire <NUM> may extend beyond the end of the implant <NUM> or may only extend into a portion of the lumen. The implant <NUM> is shown loaded onto the guidewire <NUM> and the implant container <NUM> may now be decoupled from the delivery device <NUM>.

In <FIG>, the implant <NUM> loaded onto the guidewire <NUM> and delivery device <NUM> is shown decoupled from the implant container <NUM>. In this embodiment, the guidewire <NUM> is shown straight. In <FIG>, the implant <NUM> and guidewire <NUM> are shown having a bend or curvature along a length. In this embodiment, the guidewire <NUM> or the implant <NUM> or both may have a predetermined bend or curve that resumes its natural shape. In an alternate embodiment, features or mechanisms within the implant container <NUM> may be used to deform the implant <NUM> and/or guidewire <NUM> to induce a curve or other geometry. For example, the implant container <NUM> may have a mechanism where the user can depress a component that flexes the implant <NUM> and guidewire <NUM> to a shape. The shape may be predefined or may be selected by the user depending on the force applied or distance moved. This may allow the user to control the shape of the implant <NUM> or the delivery tool <NUM> during the implantation procedure.

In <FIG>, another embodiment of the implant container <NUM> is shown including another embodiment of a retention arms <NUM> that are connected to squeeze arms <NUM> that may be depressed by the user thereby disengaging the retention arms <NUM> from a complimenting coupling feature (e.g., groove) along the delivery device <NUM> to release the implant container <NUM>. In this embodiment, the implant may be loaded into the implant housing <NUM> for positioning and loading onto the delivery device <NUM>. In <FIG>, the squeeze arm implant container <NUM> is shown coupled to the delivery device <NUM>.

In <FIG>, another embodiment of the implant container <NUM> is shown having another embodiment of a retention feature, which includes a retention pin <NUM> which sits into a groove or recess along the delivery tool <NUM> thereby securely coupling the implant container <NUM> to the delivery device <NUM>. The groove can be configured like a screw thread that allows the retention pin <NUM> to thread onto and off of the delivery device <NUM>. The implant <NUM> can be loaded into the implant housing <NUM> for positioning and loading the implant <NUM> onto the delivery device. For example, the guidewire <NUM> can be advanced into the implant lumen by depressing the loader button <NUM> and then unthreading the implant container <NUM> from the delivery device <NUM> when preparing for surgery.

In some embodiments, the implant <NUM> may already be loaded onto the delivery device. In these embodiments the implant container (such as implant container <NUM>, <NUM>, and/or <NUM>) may still serve several purposes. First the implant container <NUM>, <NUM>, <NUM> may protect the implant and prevent any damage from external forces. Second, the implant container <NUM>, <NUM>, <NUM> may hold the implant <NUM> in a desired shape or configuration. For example, in the embodiment where the guidewire <NUM> has a curve at its distal end, the implant container may hold the guidewire straight during the shipping of the device such that the implant is held straight and not subjected to unwanted forces during shipping or storage. In this case the implant container may be removed before the surgical procedure through any number of methods described herein.

In all described configurations, to abut the proximal end of the implant <NUM> against the distal end of the hypotube <NUM> during loading, the guidewire <NUM> may be over-stroked through the implant <NUM> beyond its final intended position (while features of the container providing a distal hard stop for the implant), resulting in the guidewire <NUM> pulling the implant <NUM> proximally (via implant retention features on the guidewire) during its return-stroke with the guidewire hard stopping on the hypotube.

In another embodiment, the implant container may contain features that either permit or prevent re-capping the implant container onto a delivery device. For example, the implant container can irreversibly split into two or more pieces after loading of the implant and removal of the container, thereby not allowing the user to re-cap the container. In another embodiment, the implant container can contain a member that springs to close off the lumen after loading of the implant and removal of the implant container.

The implant container may contain a springing feature that biases the implant proximally, so as to bias the implant towards the correct position during initial loading. In the case of the auto ejecting implant container, various features such as speed bumps on the handle where the retention arm interfaces or a tether connecting the container to the handle body may be used to facilitate the profile of the container's ejection. The implant container design can also include various aerodynamic and friction elements to modify the profile of the container's ejection and minimize the ability to slide along flat surfaces such as tables or floors.

In another embodiment, the implant container may be locked on the delivery tool and cannot be removed with a normal user's hand-grip force until the user has loaded the implant. This is a variation on the embodiments above, where the user actively unlocks or auto ejects the implant container. In this alternative embodiment, the container is not auto ejected, but the only action the user takes to allow the container to be removed is load the implant. Once the implant is loaded, the user can then proceed to remove the container. There can be a change in the container to signal to the user that it is now unlocked and can be removed, such as the appearance of a different color on the delivery tool handle (such as a green label appearing inside of a slot) or in the container itself.

In another embodiment, the implant may be held or contained in a specific environment within the implant container such as a fluid or gaseous environment. This may be beneficial for certain implant materials or configurations. For example, the implant may be maintained in a saline solution and/or a therapeutic drug within the implant container. For example, the chamber or implant housing can be fully are partially sealed to allow the saline and/or therapeutic drug to coat the implant, such as during storage.

In another embodiment, the implant container may be a sheath that holds the implant concentrically on the end of the delivery device and translates toward the delivery device as the implant is inserted in the eye. For example, the implant container can be spring loaded proximally such that it contains the implant at the distal end but is able to move proximally and reveal the implant. In this embodiment, the delivery device can be inserted into the eye and the implant container can be constrained by the corneal incision such that only the implant and the hypotube enter the eye.

Claim 1:
An ocular implant container (<NUM>), comprising:
a container housing having a proximal end configured to couple to an implant delivery device (<NUM>); and
an implant housing (<NUM>) integrated with the container housing and configured to align and releasably secure an ocular implant (<NUM>) for loading onto the implant delivery device, the implant housing (<NUM>) including a chamber sized to provide a friction fit with the ocular implant, the implant housing further including a delivery passageway (<NUM>) in communication with the chamber and extending between the chamber and the proximal end of the container housing, the delivery passageway (<NUM>) having a circular cross-section and configured to provide a sliding fit with a delivery feature of the implant delivery device, wherein the delivery feature includes a hypotube (<NUM>).