Patent Application
20240016600
The invention set forth in the appended claims relates generally to eye surgery. More particularly, but without limitation, the claimed subject matter relates to systems, apparatuses, and methods for inserting an implant into an eye.
The human eye can suffer a number of maladies causing mild deterioration to complete loss of vision. While contact lenses and eyeglasses can compensate for some ailments, ophthalmic surgery may be required for others. In some instances, implants may be beneficial or desirable. For example, an intraocular lens may replace a clouded natural lens within an eye to improve vision.
While the benefits of intraocular lenses and other implants are known, improvements to delivery systems, components, and processes continue to improve outcomes and benefit patients.
New and useful systems, apparatuses, and methods for eye surgery are set forth in the appended claims Illustrative embodiments are also provided to enable a person skilled in the art to make and use the claimed subject matter.
For example, some embodiments may comprise or consist essentially of an apparatus for delivering an implant, such as an intraocular lens, using hydraulic pressure or fluid flow. The apparatus may be combined with a disposable hydraulic cartridge, such as a vial of working fluid, to provide a fully disposable system for storing, advancing, and delivering an implant.
In more particular examples, the apparatus may comprise a rigid plunger for advancing an implant to a sealed position in a first phase, and a bore through the rigid plunger that allows a working fluid to advance the implant into the eye via hydraulic pressure in a second phase. For example, a hollow rigid plunger can be used to first advance an intraocular lens with haptics in a straightented configuration to a point that a seal is created about the intraocular lens within a delivery lumen. The lens may then be hydraulically advanced to delivery by passing a working fluid through the hollow bore of the plunger. The apparatus may additionally comprise a plunger stop, which may be configured to stop advancement of the implant interface or the plunger.
In yet more particular embodiments, the apparatus may have a nozzle, a plunger, a plunger rod, and a chamber configured to receive a cartridge between the plunger and the plunger rod. To maintain a compact configuration, the plunger rod may be placed in a forward position for shipping and storage. For operation, the plunger rod may be placed in an aft position to allow the cartridge to be inserted into the chamber between the plunger and the plunger rod. The plunger rod may be advanced toward the cartridge to couple the cartridge to the plunger. The plunger rod, the cartridge, and the plunger may be advanced further to advance the implant to a sealed position in the nozzle. Further advancement of the plunger rod can drive a working fluid from the cartridge and through a bore in the plunger to eject the implant from the nozzle.
More generally, a system for using a cartridge for eye surgery may comprise a nozzle, an implant bay coupled to the nozzle, an implant disposed in the implant bay, and an actuator. The actuator may comprise a plunger and a chamber configured to receive the cartridge. The actuator may be configured to fluidly couple the cartridge to the implant bay. In a first delivery phase, the actuator may move the plunger to advance the implant into the nozzle. In a second delivery phase, the actuator may move a working fluid from the cartridge through the plunger to advance the implant through the nozzle. In more particular embodiments, the actuator may further comprise a plunger rod and a bore through the plunger. The plunger rod may be configured to advance the plunger and to move the working fluid from the cartridge through the bore to advance the implant through the nozzle. Some embodiments of the plunger may comprise a coupling configured to fluidly couple the cartridge to the implant bay. Additionally, or alternatively, some embodiments of the system may comprise a lead nut, which may be threaded onto a threaded portion of the plunger rod. The plunger rod may be configured to be rotated through the lead nut to move the working fluid and may be configured to maintain a relative position between the plunger rod and the cartridge as the implant is advanced from the implant bay to the nozzle. In yet more particular embodiments, the cartridge may comprise a cartridge seal, and the plunger rod may be configured to advance the cartridge seal to move the working fluid. For example, the plunger rod may be configured to be rotated through a lead nut to advance the cartridge seal.
In other examples, a system for using a hydraulic cartridge for eye surgery may comprise a nozzle, an implant bay coupled to the nozzle, an implant disposed in the implant bay, a housing coupled to the implant bay, a plunger disposed within the housing, and a plunger rod at least partially disposed within the housing. The system may additionally comprise a bore through the plunger, which can be fluidly coupled to the implant bay. A chamber may be configured to receive the hydraulic cartridge between the plunger and the plunger rod. The plunger rod may be configured to move the hydraulic cartridge and the plunger within the housing to advance the implant from the implant bay to the nozzle in a first delivery phase. The plunger rod may be operable to drive a working fluid from the hydraulic cartridge through the bore to advance the implant through the nozzle in a second delivery phase.
In yet other examples, a system for using a hydraulic cartridge for eye surgery may comprise a nozzle, an implant bay coupled to the nozzle, an implant disposed in the implant bay, a housing coupled to the implant bay, a plunger configured to slide within the housing, a bore through the plunger, and a plunger rod having a threaded end disposed within the housing. A lead nut may be threaded onto the threaded end of the plunger rod, and a chamber may be configured to receive the hydraulic cartridge between the plunger and the lead nut. The plunger rod may be configured to be pushed or to otherwise slide to advance the lead nut, the hydraulic cartridge, and the plunger to advance the implant from the implant bay to the nozzle in a first delivery phase. The plunger rod may be configured to be rotated through the lead nut to drive a working fluid from the hydraulic cartridge through the bore to advance the implant through the nozzle in a second delivery phase.
Features, elements, and aspects described in the context of some embodiments may also be omitted, combined, or replaced by alternative features. Other features, objectives, advantages, and a preferred mode of making and using the claimed subject matter are described in greater detail below with reference to the accompanying drawings of illustrative embodiments.
The accompanying drawings illustrate some objectives, advantages, and a preferred mode of making and using some embodiments of the claimed subject matter. Like reference numbers represent like parts in the examples.
The following description of example embodiments provides information that enables a person skilled in the art to make and use the subject matter set forth in the appended claims, but it may omit certain details already well known in the art. The following detailed description is, therefore, to be taken as illustrative and not limiting.
The example embodiments may also be described herein with reference to spatial relationships between various elements or to the spatial orientation of various elements depicted in the attached drawings. In general, such relationships or orientation assume a frame of reference consistent with or relative to a patient in a position to receive an implant. However, as should be recognized by those skilled in the art, this frame of reference is merely a descriptive expedient rather than a strict prescription.
In general, components of the system 100 may be coupled directly or indirectly. For example, the nozzle 105 may be directly coupled to the implant bay 110 and may be indirectly coupled to the actuator 115 through the implant bay 110. Coupling may include fluid, mechanical, thermal, electrical, or chemical coupling (such as a chemical bond), or some combination of coupling in some contexts. For example, the actuator 115 may be mechanically and fluidly coupled to the nozzle 105. In some embodiments, components may also be coupled by virtue of physical proximity, being integral to a single structure, or being formed from the same piece of material.
The nozzle 105 generally comprises a tip adapted for insertion through an incision into an eye. The size of the tip may be adapted to surgical requirements and techniques as needed. For example, small incisions are generally preferable to reduce or minimize healing times. Incisions of less than 3 millimeters may be preferable in some instances, and the tip of the nozzle 105 may have a width of less than 3 millimeters in some embodiments.
The implant bay 110 generally represents a wide variety of apparatuses that are suitable for storing an implant prior to delivery into an eye. In
In some embodiments, the implant bay 110 may additionally or alternatively be configured to prepare the implant 120 for delivery. For example, some embodiments of the implant bay 110 may be configured to be actuated by a surgeon or other operator to prepare the implant 120 for delivery by subsequent action of the actuator 115. In some instances, the implant bay 110 may be configured to actively deform, elongate, extend, or otherwise manipulate features of the implant 120 before the implant 120 is advanced into the nozzle 105. For example, some embodiments of the implant bay 110 may be configured to orient, fold, or splay an implant.
The actuator 115 of
In some embodiments, the actuator 115 may additionally comprise a nozzle seal 160. As illustrated in the example of
As illustrated in the example of
The chamber 165 may be configured to receive a cartridge 175, which may contain a working fluid 180. Suitable working fluids may include, without limitation, a liquid, such as saline, or a viscous lubricant with non-Newtonian properties. The cartridge 175 may then be inserted into the chamber 165 to prepare the system 100 to deliver the implant 120. In other examples, the cartridge 175 may be transported and stored in the chamber 165. The cartridge 175 generally comprises a cartridge tip 185 and a cartridge seal 190. A cap 195 may be initially disposed over the cartridge tip 185. The cartridge seal 190 and the cap 195 together may contain the working fluid 180 within the cartridge 175, which may be suitable for transporting and storing the cartridge 175. In some embodiments, the cartridge 175 may comprise or consist essentially of a vial of working fluid. Suitable working fluids may include, without limitation, a liquid, such as saline, or a viscous lubricant with non-Newtonian properties.
For example, if assembled as illustrated in
In the example of
In the example of
As illustrated in the example of
The actuator 115 of
The chamber 165 of
For example, if assembled as illustrated in
In the example of
In the example of
As illustrated in the example of
After the incision 505 is made, the nozzle 105 can be inserted through the incision 505 so that the tip of the nozzle 105 aligns with the incision 505, allowing the nozzle 105 to extend into an interior portion 525 of the eye 500. The system 100 can then eject the implant 120 through the nozzle 105 into the capsular bag 520 of the eye 500, substantially as described above with reference to
In some embodiments, the implant 120 may comprise an intraocular lens. In some instances, the implant 120 may comprise an intraocular lens that is fluid-filled, such as a fluid-filled accommodating intraocular lens. The implant 120 may also comprise an intraocular lens that includes one or more features, such as haptics, for positioning the intraocular lens within an eye. In the example of
In some applications, the implant 120 may be delivered in a folded, straightened, or splayed configuration and can revert to an initial, resting state, within the capsular bag 520, as shown in
The systems, apparatuses, and methods described herein may provide significant advantages. For example, some embodiments may be particularly advantageous for delivering intraocular lenses, including fluid-filled accommodating lenses, which can present unique challenges for delivery. Some embodiments can compress a relatively large lens to fit through an acceptably small incision, manage deformation caused by shifting fluid during compression and exit from a nozzle, and execute delivery in a predictable and controlled manner Additionally, some embodiments can reduce system complexity and the number of delivery steps while maintaining haptic position consistency. Some embodiments may also reduce the amount of working fluid for delivery. For example, a single vial of ophthalmic viscosurgical device (OVD), such as vial of CELLUGEL OVD, PROVISC OVD, OR DISCOVISC OVD, may be used to drive some embodiments of the system 100 and provide the working fluid for delivery. Additionally, or alternatively, some embodiments may be particularly advantageous for providing multiple delivery modes in a single apparatus. For example, a first delivery mode can allow an operator to advance an implant to a dwell position by pushing a plunger rod. A second delivery mode can allow an operator to twist the plunger rod to advance an implant, which can give the operator finer position control as the implant is delivered.
While shown in a few illustrative embodiments, a person having ordinary skill in the art will recognize that the systems, apparatuses, and methods described herein are susceptible to various changes and modifications that fall within the scope of the appended claims. Moreover, descriptions of various alternatives using terms such as “or” do not require mutual exclusivity unless clearly required by the context, and the indefinite articles “a” or “an” do not limit the subject to a single instance unless clearly required by the context. Components may also be combined or eliminated in various configurations for purposes of sale, manufacture, assembly, or use. For example, in some configurations, the nozzle 105, the implant bay 110, and the actuator 115 may each be separated from one another or combined in various ways for manufacture or sale.
The claims may also encompass additional subject matter not specifically recited in detail. For example, certain features, elements, or aspects may be omitted from the claims if not necessary to distinguish the novel and inventive features from what is already known to a person having ordinary skill in the art. Features, elements, and aspects described in the context of some embodiments may also be omitted, combined, or replaced by alternative features serving the same, equivalent, or similar purpose without departing from the scope of the invention defined by the appended claims.
| Number | Date | Country | |
|---|---|---|---|
| 63368173 | Jul 2022 | US |
