RU2840038C2 - Hydraulic delivery of surgical intraocular lenses - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: ophthalmic surgery device can comprise a tip having a delivery lumen, an implant cell connected to the tip, an implant located in the implant cell, and an actuator connected to the implant cell. Actuator can comprise a housing, a plunger disposed within the housing, a channel extending through the plunger, a first coupling located near the first end of the plunger, and a second coupling made integral with the housing. Channel can be fluidly connected to the implant cell. First coupling can be made with the possibility of receiving the hydraulic drive and fluid connection of the working fluid in the hydraulic drive with the channel. Portion of the plunger can slide through the second coupling. In some embodiments, the second coupling can be configured to hold the drive coupling of the hydraulic drive in a fixed position relative to the housing.

EFFECT: use of this group of inventions enables to compress a relatively large lens for passage through an acceptably small incision, controlling deformation caused by fluid movement during compression and exit from the tip, and delivery in a predictable and controlled manner.

19 cl, 3 dwg

Description

CLAIM TO PRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63/112,692, entitled "HYDRAULIC DELIVERY OF SURGICAL IMPLANTS," filed November 12, 2020, and assigned to Todd Taber, Kathryn Jensen, Jestwin Edwin Lee, IV, Pradeep Magadum, Saumya Dilip Yadav, which is hereby incorporated by reference in its entirety as if set forth in its entirety herein.

AREA OF TECHNOLOGY

[0002] The present invention, as set forth in the appended claims, relates generally to ocular surgery. More particularly, but without limitation, the claimed subject matter relates to systems, devices, and methods for inserting an implant, namely an intraocular lens, into an eye.

LEVEL OF TECHNOLOGY

[0003] The human eye can suffer from a number of conditions that can cause a range from mild impairment to complete loss of vision. While contact lenses and glasses can compensate for some ailments, others may require eye surgery. In some cases, implants may be helpful or desirable. For example, an intraocular lens can replace a cloudy natural lens in the eye to improve vision.

[0004] While the benefits of intraocular lenses and other implants are known, improvements in delivery systems, components, and processes continue to improve outcomes and benefit patients.

ESSENCE OF THE INVENTION

[0005] New and suitable systems, devices and methods for ocular surgery are set forth in the appended claims. Also provided are illustrative embodiments that enable a person skilled in the art to make and use the claimed subject matter of the invention.

[0006] For example, some embodiments may comprise or essentially consist of a device for delivering an implant, such as an intraocular lens (IOL), using hydraulic pressure or fluid flow. The device may be combined with a disposable hydraulic actuator, such as an ampoule with a working fluid, to provide a completely disposable system for storing, advancing and delivering the implant. In more specific examples, the device may comprise a rigid plunger for advancing the implant (IOL) into a sealed position in a first phase and a channel in the rigid plunger that allows the working fluid to advance the implant into the eye under the action of hydraulic pressure in a second phase. For example, a hollow rigid plunger may be used to first advance the intraocular lens in a rectilinear configuration to the point at which a seal is created around the intraocular lens within the lumen for delivery. The lens can then be hydraulically advanced for delivery by passing the working fluid through the hollow channel of the plunger. In some embodiments, the plunger tip may have an interface for an implant (an interface device for an intraocular lens). For example, the tip may have a notch for engaging with the shoulder of the optical body of the lens and advancing the lens into the lumen for delivery. The device may further comprise a plunger stop, which may be configured to stop the advancement of the interface (interface device) for the implant or the plunger.

[0007] In other more specific embodiments, an ampoule with a working fluid can be used as a hydraulic actuator for advancing and delivering an intraocular lens in a delivery system. For example, the ampoule can be connected via a luer lock to the rear of a plunger in the delivery system. The delivery system can straighten one or more haptic portions of the lens, for example, a front haptic portion, and prepare the lens for advancement. The ampoule can advance forward, thereby advancing the plunger and the lens to a second position in which the end of the ampoule engages a sleeve in the delivery system. The sleeve can prevent the ampoule from being removed. For example, the ampoule can have an external thread, and the sleeve can have an internal thread configured to receive the external thread of the ampoule. The ampoule may have a second plunger that may be depressed to move the working fluid out of the ampoule and through a channel in the plunger of the delivery system to eject the lens from the delivery system.

[0008] In a more general sense, a device for advancing an implant in an implant delivery system may comprise a housing, a plunger located inside the housing, a channel passing through the plunger from a first end to a second end, a first sleeve located near the first end, and a second sleeve formed integrally with the housing. The channel may be configured to be in fluid communication with a cell for an implant. The first sleeve may be configured to receive a hydraulic actuator and to be in fluid communication with a working fluid in the hydraulic actuator with the channel. A portion of the plunger may slidably pass through the second sleeve, and the second end of the plunger may be configured to engage with the implant. In some embodiments, the second sleeve may be configured to hold the drive sleeve of the hydraulic actuator in a fixed position relative to the housing. In more specific embodiments, the second sleeve may comprise or essentially consist of a threaded lock configured to engage with the drive sleeve.

[0009] In other embodiments, an ophthalmic surgery device may comprise a tip having a delivery lumen, an implant cell connected to the tip, an implant located in the implant cell, and an actuator connected to the implant cell. The actuator may comprise a housing, a plunger located inside the housing, a channel passing through the plunger, a first sleeve located near a first end of the plunger, and a second sleeve formed integrally with the housing. The channel may be fluidly connected to the implant cell. The first sleeve may be configured to receive a hydraulic actuator and to fluidly connect the working fluid in the hydraulic actuator to the channel. A portion of the plunger may slidably pass through the second sleeve. In some embodiments, the second sleeve may be configured to hold the drive sleeve of the hydraulic actuator in a fixed position relative to the housing. In more specific embodiments, the second coupling may comprise or essentially consist of a threaded lock configured to engage with the drive coupling.

[0010] A method for ejecting an implant from an implant delivery system may include providing an implant in an implant cell. In some examples, the implant may be a lens, such as an intraocular lens. A hydraulic actuator may be connected to a rigid plunger of the implant delivery system, and the hydraulic actuator may operate the rigid plunger to advance the implant from the implant cell into a delivery lumen in the implant delivery system. The hydraulic actuator may be held in a fixed position relative to the implant delivery system. A hydraulic fluid in the hydraulic actuator may be pressurized to move the hydraulic fluid through a channel in the rigid plunger into the delivery lumen, and the hydraulic fluid may advance the implant through the delivery lumen.

[0011] Such embodiments may be particularly advantageous for delivering intraocular lenses, including accommodating lenses, which may present unique delivery challenges. Some embodiments may control the fluid in the accommodating lens to compress a relatively large lens to advance through an acceptably small incision, control the deformation caused by the movement of the fluid during compression and exit from the tip, and deliver in a predictable and controlled manner. The intraocular lens may further include one or more haptic elements that may extend radially to secure the lens within the eye. Some embodiments may reduce the complexity of the system and the number of delivery steps while maintaining consistency of haptic position. Some embodiments may also reduce the amount of working fluid to deliver.

[0012] Features, elements and aspects described in the context of some embodiments may also be omitted, combined or replaced with alternative features. Other features, objects, advantages and a preferred method of making and using the claimed subject matter are described in more detail below with reference to the accompanying drawings of illustrative embodiments.

BRIEF DESCRIPTION OF GRAPHIC MATERIALS

[0013] The accompanying drawings illustrate certain objects, advantages, and a preferred method of making and using certain embodiments of the claimed subject matter. Like reference numbers represent like parts in the examples.

[0014] Fig. 1 is a schematic illustration of an exemplary system for introducing an implant into an eye.

[0015] Figs. 2A-2C are schematic views illustrating the operation of the exemplary system shown in Fig. 1.

[0016] Fig. 3A-3B are schematic views illustrating an example of the use of the system shown in Fig. 1 for inserting an implant into the eye.

DESCRIPTION OF ILLUSTRATIVE IMPLEMENTATION OPTIONS

[0017] The following description of illustrative embodiments provides information that enables one skilled in the art to make and use the subject matter of the invention set forth in the appended claims, but may omit certain details already well known in the art. Accordingly, the following detailed description is to be considered illustrative and not restrictive.

[0018] Exemplary embodiments may also be described herein with reference to spatial relationships between various elements or to spatial orientations of various elements depicted in the attached drawings. In general, such relationships or orientations suggest frames of reference corresponding to or relative to a patient in a position to receive an implant. However, as will be recognized by those skilled in the art, these frames of reference are merely descriptive devices and not strict prescriptions.

[0019] Fig. 1 is a schematic illustration of a system 100 that can be used to deliver an implant into an eye. For example, as illustrated in Fig. 1, some embodiments of the system 100 may include a tip 105, an implant cell 110 that can be connected to the tip 105, and an actuator 115 that can be connected to the implant cell 110.

[0020] In general, the components of the system 100 may be directly or indirectly connected. For example, the tip 105 may be directly connected to the implant cell 110 and may be indirectly connected to the actuator 115 through the implant cell 110. The connection may include a fluid, mechanical, thermal, electrical, or chemical connection (such as a chemical bond), or some combination of connections in some contexts. For example, the actuator 115 may be mechanically and fluidly connected to the tip 105. In some embodiments, the components may also be connected by virtue of being located close together, being an integral part of a single structure, or being formed from the same piece of material.

[0021] The tip 105 typically comprises a tip adapted for insertion through an incision into the eye. The tip size can be adapted to the surgical requirements and techniques, if necessary. For example, small incisions are generally preferred to reduce or minimize healing time. Incisions less than 3 millimeters may be preferred in some cases, and the tip of the tip 105 may have a width of less than 3 millimeters in some embodiments. The tip 105 shown in FIG. 1 has a lumen 120 for delivery.

[0022] The implant cell 110 is typically a wide variety of devices that are suitable for storing an implant prior to delivery to the eye. For example, in Fig. 1, the implant 125 is located in the implant cell 110.

[0023] The actuator 115 shown in Fig. 1 typically includes a housing 130, a plunger 135 located inside the housing 130, and a channel 140 passing through the plunger 135. The plunger 135 typically consists of a substantially rigid material, such as a medical-grade polymer material. The channel 140 typically passes through the plunger 135 in a longitudinal direction from a first end 145 to a second end 150. The actuator 115 may further include a first sleeve 155 located near the first end 145 of the plunger 135. The second sleeve 160 may be formed integrally with the housing 130, and a portion of the plunger 135 may slidably pass through the second sleeve 160.

[0024] In some embodiments, the actuator 115 may further comprise a tip seal 165. As illustrated in the example of Fig. 1, the tip seal 165 may be an annular seal, such as an O-ring, located circumferentially around a portion of the plunger 135. In other examples, an umbrella seal may be suitable. In more specific embodiments, the tip seal 165 may be located near the second end 150 of the plunger 135.

[0025] Some embodiments of the actuator 115 may also comprise an interface 170 for an IOL implant. For example, in some embodiments, the implant interface 170 shown in Fig. 1 may be connected to the second end 150 of the plunger 135.

[0026] Some embodiments of the system 100 may further include various ergonomic features. For example, the system 100 shown in Fig. 1 has a finger flange 175 connected to the actuator 115, which may facilitate manipulation of the system 100 with one hand.

[0027] Figs. 2A-2C are schematic views illustrating the operation of the system 100 shown in Fig. 1. Initially, the various components of the system 100 may be assembled if desired. In the example shown in Figs. 2A-2C, the tip 105, the IOL cell 110, and the actuator 115 are secured together to form a single structure. In other embodiments, the system 100 may comprise two or more modules that may be configured to be connected and disconnected as appropriate for storage, assembly, use, and disposal.

[0028] After assembly, as illustrated in Fig. 2A, the cell 110 for the implant can be located between the channel 140 and the lumen 120 for delivery. A portion of the plunger 135 and the coupling device (interface) 170 for the IOL can extend into the cell 110 for the IOL (implant), and the interface 170 for the implant can be configured to engage with the implant 125.

[0029] In the example of Fig. 2A, the system 100 is configured to receive a hydraulic actuator 205. The hydraulic actuator 205 shown in Fig. 2A typically includes a drive coupling 210, a working fluid 215, and a driving plunger 220. In some embodiments, the hydraulic actuator 205 may include or consist essentially of an ampoule with a working fluid. Suitable working fluids may include, but are not limited to, a liquid such as a saline solution or a viscous lubricant with non-Newtonian properties.

[0030] The first coupling 155 of the actuator 115 may be configured to receive the hydraulic actuator 205 and to fluidly connect the working fluid 215 in the hydraulic actuator 205 to the channel 140. For example, the drive coupling 210 may be configured to connect to the first coupling 155 of the actuator 115. In some embodiments, the first coupling 155 may be a luer lock, a luer cone, or a similar coupling configured to receive the drive coupling 210. For example, the first coupling 155 may comprise a male luer lock having at least one locking projection 225, and the drive coupling 210 may comprise a female luer lock configured to receive the locking projection 225 of the first coupling 155. The drive coupling 210 may further have an external thread 230.

[0031] The implant 125 may be provided in the implant cell 110, as illustrated in the example of Fig. 2A. In some embodiments, the implant 125 may comprise an intraocular lens having a shape similar to the shape of the natural lens of the eye, and it may be made of a variety of materials. Examples of suitable materials may include silicone, acrylic, and combinations of such suitable materials. In some cases, the implant 125 may comprise an intraocular lens that is filled with a liquid, such as a liquid-filled accommodating intraocular lens. The implant 125 may also comprise an intraocular lens having one or more elements, such as haptic portions, for positioning the intraocular lens in the eye.

[0032] In some embodiments, the IOL cell 110 may additionally or alternatively be configured to prepare the IOL 125 for delivery. For example, some embodiments of the IOL(implant) cell 110 may be configured to be actuated by a surgeon or other operator to prepare the implant 125 for delivery via subsequent operation of the actuator 115. In some cases, the IOL cell 110 may be configured to actively deform, extend, expand, or otherwise manipulate features of the implant 125 before the implant 125 is advanced into the tip 105. For example, some embodiments of the implant cell 110 may be configured to orient or fold the implant. For example, the implant 125 may comprise one or more haptics that can be oriented for delivery.

[0033] The plunger 135 is typically configured to advance the implant 125 from the implant cell 110 into the lumen 120 for delivering the tip 105. For example, if the drive sleeve 210 is connected to the first sleeve 155, a force can be applied to the hydraulic actuator 205 to move the hydraulic actuator 205 and the plunger 135 within the housing 130 from the first configuration, illustrated in the example of Fig. 2A, to the second configuration, as illustrated in the example of Fig. 2B. For example, in the embodiment shown in Fig. 2A, the hydraulic actuator 205 comprises a flange 250, and pressure can be applied to the flange 250 to rigidly move the hydraulic actuator 205 and the plunger 135 into the second configuration while maintaining the relative position of the drive plunger 220 and the hydraulic fluid 215. As illustrated in the example of Fig. 2B, the implant 125 can also be advanced into the lumen 120 for delivery of the tip 105 by the interface 170 for the implant. In the second configuration, the seal 165 of the tip is also advanced into the lumen 120 for delivery to create a seal in the lumen 120 for delivery behind the implant 125. The implant 125 can also, in some cases, form a seal with the lumen 120 for delivery. In the configuration shown in Fig. 2B, the channel 140 can provide a fluid connection of the working fluid 215 in the hydraulic actuator 205 with the clearance 120 for delivery.

[0034] The drive clutch 210 may engage with the second clutch 160 of the actuator 115 to hold the drive clutch 210 in a stationary position relative to the housing 130. For example, as illustrated in FIG. 2C, the drive coupling 210 can be inserted into the second coupling 160 to hold the drive coupling 210 against additional force applied to the hydraulic actuator 205. In some embodiments, the second coupling 160 can comprise a threaded lock configured to engage with the threads 230 of the drive coupling 210 to prevent further linear movement of the drive coupling 210. A suitable threaded lock can comprise internal threads, teeth or a ratchet system configured to one-sidedly insert the threads 230 into the second coupling 160, preventing further linear movement of the drive coupling 210 after it is inserted into the second coupling 160.

[0035] With the drive sleeve 210 held, the drive plunger 220 can be advanced into a third configuration, as illustrated in Fig. 2C, forcing the working fluid 215 through the channel 140 into the delivery lumen 120 behind the implant 125. The movement of the working fluid 215 from the channel 140 into the delivery lumen 120 under the pressure of the drive plunger 220 can increase the pressure and flow rate of the working fluid 215 in the delivery lumen 120 behind the implant 125, which can advance the implant 125 further through the delivery lumen 120 until the implant 125 is pushed out of the tip 105.

[0036] Fig. 3A-3B are schematic illustrations that further illustrate an example of using the system 100 for delivering the implant 125 into the eye 300. For example, as illustrated, the surgeon may make an incision 305 in the eye 300. In some cases, the incision 305 may be made through the sclera 310 of the eye 300. In other cases, the incision may be made in the cornea 315 of the eye 300. The incision 305 may be of a size that allows insertion of a portion of the tip 105 for delivering the implant 125 into the capsular bag 320. For example, in some cases, the size of the incision 305 may be less than about 3000 microns (3 millimeters) in length. In other cases, the slit 305 may have a length of from about 1000 microns to about 1500 microns, from about 1500 microns to about 2000 microns, from about 2000 microns to about 2500 microns, or from about 2500 microns to about 3000 microns.

[0037] After the incision 305 is made, the tip 105 may be inserted through the incision 305 into the interior 325 of the eye 300. The system 100 may then push the implant 125 through the tip 105 into the capsular bag 320 of the eye 300, substantially as described above with reference to Figs. 2A-2C. In some applications, the implant 125 may be delivered in a folded configuration and may be returned to its original, expanded state within the capsular bag 320, as shown in Fig. 3B. In the example shown in Fig. 3A and Fig. 3B, the implant 125 illustrates an intraocular lens having an optical body 330, an anterior haptic portion 335, and a posterior haptic portion 340. For example, the implant 125 may be in the form of an accommodating intraocular lens having one or more optical bodies 330, an anterior haptic portion 335, and a posterior haptic portion 340 filled with fluid. The capsular bag 320 may hold the implant 125 within the eye 300 in a position relative to the eye 300 such that the optical body 330 refracts light directed toward the retina (not shown). The anterior haptic portion 335 and the posterior haptic portion 340 may engage with the capsular bag 320 to secure the implant 125 therein. After the implant 125 has been dispensed into the capsular bag 320, the tip 105 may be removed from the eye 300 through the incision 305, and the eye 300 is allowed to recover for a period of time.

[0038] The systems, devices, 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 may present unique delivery challenges. Some embodiments may compress a relatively large lens to pass through an acceptably small incision, control the deformation caused by fluid movement during compression and exit from the tip, and deliver in a predictable and controlled manner. Additionally, some embodiments may reduce the complexity of the system 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 ampoule of an ophthalmic viscosurgical device (OVD), such as a CELLUGEL OVD ampoule, may be used to actuate some embodiments of the system 100 and deliver the working fluid for delivery.

[0039] Although shown in several illustrative embodiments, one skilled in the art will understand that the systems, devices 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 the context clearly requires it, and the singular forms do not limit the subject matter to one occurrence unless the context clearly requires it. Components may also be combined or excluded in various configurations for purposes of sale, manufacture, assembly or use. For example, in some configurations, the tip 105, the implant cell 110 and the actuator 115 may be separated from each other or combined in various ways for manufacture or sale. The claims may also cover additional subject matter of the invention not specifically described in detail. For example, certain features, elements or aspects may be omitted from the claims if there is no need to distinguish novelty and inventive step from what is already known to a person skilled 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 present invention as defined by the appended claims.

Claims (41)

1. A device for delivering an intraocular lens, comprising: a tip having a lumen for delivery; an intraocular lens cell connected to the tip; an intraocular lens located in an intraocular lens cell; and an actuator coupled to the intraocular lens cell, the actuator comprising: frame, a plunger located inside the housing, the plunger having a first end and a second end, channel passing through the plunger, a first coupling located near the first end, and the second coupling, made in one piece with the body; wherein the channel is fluidly connected to the cell for the intraocular lens, the first coupling is designed with the possibility of receiving a hydraulic drive and fluidly connecting the working fluid in the hydraulic drive with the channel, and a part of the plunger with the possibility of sliding passes through the second coupling. 2. The device according to item 1, in which the second coupling is designed with the possibility of holding the drive coupling of the hydraulic drive in a fixed position relative to the housing. 3. The device according to claim 2, wherein the second coupling comprises a threaded lock configured to engage with the drive coupling. 4. The device according to claim 3, wherein the threaded valve comprises an internal thread configured to receive an external thread on the drive coupling. 5. The device according to claim 3, wherein the threaded lock comprises teeth. 6. The device according to claim 3, wherein the threaded lock comprises a ratchet system. 7. The device of any one of the preceding claims, further comprising a tip seal located adjacent the second end of the plunger. 8. The device according to any one of the preceding claims, further comprising an interfacing device for an intraocular lens connected to the second end of the plunger and configured to engage with the intraocular lens. 9. The device of claim 8, wherein the intraocular lens interface extends into the intraocular lens cell. 10. A device for advancing an intraocular lens in an intraocular lens delivery system, the device comprising: a housing configured to be connected to a cell for an intraocular lens; a plunger located inside the housing, the plunger having a first end and a second end; a channel passing through the plunger in a longitudinal direction from the first end to the second end; a first coupling located near the first end; and the second coupling, made in one piece with the body; wherein the channel is designed with the possibility of liquid connection with the cell for the intraocular lens, the first coupling is designed with the possibility of receiving a hydraulic drive and liquid connection of the working fluid in the hydraulic drive with the channel, and a part of the plunger with the possibility of sliding passes through the second coupling, and the second end of the plunger is designed with the possibility of engagement with the intraocular lens. 11. The device according to item 10, wherein the second coupling is designed with the possibility of holding the drive coupling of the hydraulic drive in a fixed position relative to the housing. 12. The device according to claim 11, wherein the second coupling comprises a threaded lock configured to engage with the drive coupling. 13. The device according to claim 12, wherein the threaded valve comprises an internal thread configured to receive an external thread on the drive coupling. 14. The device according to claim 12, wherein the threaded lock comprises teeth. 15. The device according to claim 12, wherein the threaded lock comprises a ratchet system. 16. The device according to any one of paragraphs. 10-15, further comprising a tip seal located near the second end of the plunger. 17. The device according to any one of claims 10-16, further comprising a coupling device for an intraocular lens connected to the second end of the plunger and configured to engage with the intraocular lens. 18. The device according to claim 17, wherein the coupling device for the intraocular lens is configured to pass into the cell for the intraocular lens. 19. A method for ejecting an intraocular lens from an intraocular lens delivery system, comprising: providing an intraocular lens in an intraocular lens cell of an intraocular lens delivery system; connecting the hydraulic drive to the rigid plunger of the intraocular lens delivery system; actuating a rigid plunger using a hydraulic actuator to advance an intraocular lens from an intraocular lens cell into a delivery lumen of an intraocular lens delivery system; maintaining the hydraulic drive in a stationary position relative to the intraocular lens delivery system; forcing the working fluid out of the hydraulic actuator to move the working fluid through a channel in the rigid plunger into the delivery lumen; and Advancing the intraocular lens through the delivery lumen with the working fluid.