Hydraulic delivery of surgical implants

Abstract

To provide a device for ophthalmic surgery.SOLUTION: The system can include a nozzle having a delivery lumen, an implant compartment coupled to the nozzle, an implant disposed within the implant compartment, and an actuator coupled to the implant compartment. The actuator may include a housing, a plunger disposed within the housing, a bore through the plunger, a first coupling proximate a first end of the plunger, and a second coupling integral to the housing. The bore may be fluidly coupled to the implant compartment. The first coupling may be configured to receive the hydraulic driver and fluidly couple hydraulic fluid in the hydraulic driver to the bore. A portion of the plunger may be slidingly disposed within the second coupling.SELECTED DRAWING: Figure 2A

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 112,692, entitled "HYDRAULIC DELIVERY OF SURGICAL IMPLANTS," filed November 12, 2020, the inventors of which are Todd Taber, Kathryn Jensen, Jestwin Edwin Lee, IV, Pradeep Magadum, and Saumya Dilip Yadav, the entire contents of which are incorporated herein by reference as if fully and completely set forth herein.

[0002] The present invention as recited in the accompanying claims relates generally to ophthalmic surgery. More particularly, but not by way of limitation, the claimed subject matter relates to systems, devices and methods for inserting implants into the eye. [Background technology]

[0003] The human eye can suffer from many diseases that cause anything from mild deterioration to complete loss of vision. Contact lenses and eyeglasses can compensate for some diseases, but in other cases, eye surgery may be necessary. In some cases, implants may be beneficial or desirable. For example, intraocular lenses can replace the 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. Summary of the Invention [Means for solving the problem]

[0005]

[0006] Novel and useful systems, devices, and methods for ophthalmic surgery are set forth in the appended claims. Exemplary embodiments are also provided to enable one skilled in the art to make and use the claimed subject matter.

[0006] For example, some embodiments may include or consist essentially of a device for delivering an implant, such as an intraocular lens, using fluid pressure or fluid flow. The device may be combined with a disposable hydraulic driver, such as a vial of actuating fluid, to provide a completely disposable system for storing, advancing, and delivering the implant. In a more specific example, the device may include a rigid plunger for advancing the implant to a sealed position in a first stage and a bore through the rigid plunger that allows actuating fluid to hydraulically advance the implant into the eye in a second stage. For example, a hollow rigid plunger may be used to initially advance the intraocular lens in a straight-straight configuration to a point where a seal is created around the intraocular lens within the delivery lumen. The lens may then be hydraulically advanced for delivery by passing actuating fluid through the hollow bore of the plunger. In some embodiments, the tip of the plunger may have an implant interface. For example, the tip may have a notch for engaging a shoulder on the optic of the lens to advance the lens into the delivery lumen. The device may further include a plunger stop that may be configured to stop the implant interface or the advancement of the plunger.

[0007] In other more specific embodiments, a vial of working fluid can be used as a hydraulic driver to advance and deliver an intraocular lens within a delivery system. For example, the vial can be connected to the rear of a plunger within the delivery system via a Luer lock. The delivery system can straighten one or more haptics of the lens, such as the front haptics, to prepare the lens for advancement. The vial can be advanced, thereby advancing the plunger and lens to a second position where an end of the vial engages with a coupling of the delivery system. The coupling can prevent disengagement of the vial. For example, the vial can have external threads, and the coupling can have internal threads configured to accept the external threads of the vial. The vial can have a second plunger. Depressing the second plunger can force the working fluid out of the vial and through a bore in the plunger of the delivery system, expelling the lens from the delivery system.

[0008] More generally, an apparatus for advancing an implant within an implant delivery system may include a housing, a plunger disposed within the housing, a bore extending through the plunger from a first end to a second end, a first coupling proximate the first end, and a second coupling integrated with the housing. The bore may be configured to be fluidly coupled to an implant segment. The first coupling may be configured to receive a hydraulic driver and fluidly couple a working fluid within the hydraulic driver to the bore. A portion of the plunger may be slidably disposed within the second coupling, and the second end of the plunger may be configured to engage the implant. In some embodiments, the second coupling may be configured to hold a drive coupling of the hydraulic driver in a fixed position relative to the housing. In more specific embodiments, the second coupling may include or consist essentially of a screw capture configured to engage the drive coupling.

[0009] In other embodiments, an ophthalmic surgical apparatus may include a nozzle having a delivery lumen, an implant compartment coupled to the nozzle, an implant disposed within the implant compartment, and an actuator coupled to the implant compartment. The actuator may include a housing, a plunger disposed within the housing, a bore through the plunger, a first coupling proximate a first end of the plunger, and a second coupling integrated with the housing. The bore may be fluidly coupled to the implant compartment. The first coupling may be configured to receive a hydraulic driver and fluidly couple a working fluid within the hydraulic driver to the bore. A portion of the plunger may be slidingly disposed within the second coupling. In some embodiments, the second coupling may be configured to hold a drive coupling of the hydraulic driver in a fixed position relative to the housing. In more specific embodiments, the second coupling may include or consist essentially of a screw capture configured to engage the drive coupling.

[0010] A method for ejecting an implant from an implant delivery system can include providing an implant in an implant compartment. In some examples, the implant can be a lens, such as an intraocular lens. A hydraulic driver can be coupled to a rigid plunger of the implant delivery system, and the hydraulic driver can drive the rigid plunger to advance the implant from the implant compartment into a delivery lumen of the implant delivery system. The hydraulic driver can be held in a fixed position relative to the implant delivery system. An actuating fluid in the hydraulic driver can be pushed to move the actuating fluid through a bore in the rigid plunger and into the delivery lumen, and the actuating fluid can advance the implant through the delivery lumen.

[0011] Such embodiments may be particularly advantageous for delivering intraocular lenses, including accommodating lenses, which can present unique delivery challenges. Some embodiments can compress relatively large lenses for advancement through acceptably small incisions, manage deformations caused by fluid movement during compression and ejection from the nozzle, and manage the fluid within the accommodating lens to perform delivery in a predictable and controlled manner. The intraocular lens may further include one or more haptics that can expand radially to secure the lens within the eye. Some embodiments can reduce system complexity and the number of delivery steps while maintaining consistency in haptic positioning. Some embodiments can also reduce the amount of working fluid required for delivery.

[0012] Features, elements, and aspects described in connection with some embodiments can also be omitted, combined, or substituted with alternative features. Other features, objects, advantages, and preferred modes of making and using the claimed subject matter are described in more detail below with reference to the accompanying drawings of exemplary embodiments.

[0013] The accompanying drawings illustrate certain objects, advantages, and preferred modes of making and using certain embodiments of the claimed subject matter, in which like reference numerals represent like parts. [Brief explanation of the drawings]

[0014] [Figure 1] FIG. 1 is a schematic diagram of an exemplary system for inserting an implant into the eye. [Figure 2A] FIG. 2A is a schematic diagram illustrating the operation of the exemplary system of FIG. [Figure 2B] FIG. 2B is a schematic diagram illustrating the operation of the exemplary system of FIG. [Figure 2C] FIG. 2C is a schematic diagram illustrating the operation of the exemplary system of FIG. [Figure 3A-3B] 3A-3B are schematic diagrams illustrating an exemplary application of the system of FIG. 1 for inserting an implant into the eye. DETAILED DESCRIPTION OF THE INVENTION

[0015] The following description of exemplary embodiments provides information to enable one skilled in the art to make and use the claimed subject matter, but may omit certain details already known in the art. Thus, the following detailed description is to be taken as illustrative and not limiting.

[0016] Exemplary embodiments may be described herein with reference to spatial relationships between or spatial orientations of various elements depicted in the accompanying drawings. Generally, such relationships or orientations assume a coordinate system that corresponds to or is relative to a patient positioned to receive an implant. However, as will be appreciated by those skilled in the art, this coordinate system is not strictly prescribed and is merely for descriptive convenience.

[0017] 1 is a schematic diagram of a system 100 that can be used to deliver an implant to an eye. For example, as shown in FIG. 1, some embodiments of system 100 can include a nozzle 105, an implant section 110 that can be coupled to nozzle 105, and an actuator 115 that can be coupled to implant section 110.

[0018] In general, the components of system 100 may be directly or indirectly coupled. For example, nozzle 105 may be directly coupled to implant section 110 and indirectly coupled to actuator 115 through implant section 110. Coupling may include fluid, mechanical, thermal, electrical, or chemical coupling (such as chemical adhesion), or in some circumstances, some combination of coupling. For example, actuator 115 may be mechanically and fluidly coupled to nozzle 105. In some embodiments, components may also be coupled by physical proximity, integration into a single structure, or formation from the same piece of material.

[0019] The nozzle 105 generally includes a tip adapted for insertion into the eye through an incision. The size of the tip can be adapted to surgical requirements and technique as needed. For example, small incisions are generally preferred to reduce or minimize healing time. In some instances, an incision of less than 3 millimeters may be preferred, and in some embodiments, the tip of the nozzle 105 may have a width of less than 3 millimeters. The nozzle 105 of FIG. 1 includes a delivery lumen 120.

[0020] Implant compartment 110 generally represents a variety of devices suitable for storing an implant prior to delivery into the eye. In Figure 1, for example, implant 125 is disposed within implant compartment 110.

[0021] The actuator 115 of FIG. 1 generally includes a housing 130, a plunger 135 disposed within the housing 130, and a bore 140 within the plunger 135. The plunger 135 is generally constructed of a substantially rigid material, such as a medical-grade polymeric material. The bore 140 generally extends longitudinally through the plunger 135 from a first end 145 to a second end 150. The actuator 115 may further include a first coupling 155 adjacent the first end 145 of the plunger 135. A second coupling 160 may be integral with the housing 130, and a portion of the plunger 135 may be slidingly disposed within the second coupling 160.

[0022] In some embodiments, the actuator 115 may further include a nozzle seal 165. As shown in the example of FIG. 1, the nozzle seal 165 may be a ring seal, such as an O-ring, circumferentially disposed around a portion of the plunger 135. In other examples, an umbrella seal may be appropriate. In more specific embodiments, the nozzle seal 165 may be disposed proximate the second end 150 of the plunger 135.

[0023] Some embodiments of the actuator 115 may also include an implant interface 170. For example, in some embodiments, the implant interface 170 of FIG.

[0024] Some embodiments of the system 100 may additionally include various ergonomic features. For example, the system 100 of FIG. 1 has a finger flange 175 coupled to the actuator 115, which can facilitate one-handed operation of the system 100.

[0025] 2A-2C are schematic diagrams illustrating the operation of the system 100 of FIG. 1. Initially, the various components of the system may be assembled as needed. In the example of FIGS. 2A-2C, the nozzle 105, implant section 110, and actuator 115 are secured together to form a unitary structure. In other embodiments, the system 100 may include two or more modules that may be configured to be coupled and separated as needed for storage, assembly, use, and disposal.

[0026] 2A, the implant section 110 can be disposed between the bore 140 and the delivery lumen 120. A portion of the plunger 135 and the implant interface 170 can extend into the implant section 110, and the implant interface 170 can be configured to engage the implant 125.

[0027] In the example of Figure 2A, the system 100 is configured to receive a hydraulic driver 205. The hydraulic driver 205 of Figure 2A generally includes a drive coupling 210, an actuating fluid 215, and a drive plunger 220. In some embodiments, the hydraulic driver 205 may include or consist essentially of a vial of actuating fluid. Suitable actuating fluids may include, but are not limited to, liquids such as saline or viscous lubricants having non-Newtonian properties.

[0028] The first coupling 155 of the actuator 115 may be configured to receive the hydraulic driver 205 and fluidly couple the actuation fluid 215 in the hydraulic driver 205 to the bore 140. For example, the drive coupling 210 may be configured to be coupled to the first coupling 155 of the actuator 115. In some embodiments, the first coupling 155 may be a luer lock, luer slip, or similar fitting configured to receive the drive coupling 210. For example, the first coupling 155 may include a male luer lock having at least one locking tab 225, and the drive coupling 210 may include a female luer lock configured to receive the locking tab 225 of the first coupling 155. The drive coupling 210 may further include male threads 230.

[0029] As shown in the example of FIG. 2A , an implant 125 can be provided within the implant compartment 110. In some embodiments, the implant 125 can include an intraocular lens having a shape similar to that of the eye's natural lens and can be made from a number of materials. Examples of suitable materials can include silicone, acrylic, and combinations of such suitable materials. In some cases, the implant 125 can include a fluid-filled intraocular lens, such as a fluid-filled accommodating intraocular lens. The implant 125 can also include an intraocular lens that includes one or more features, such as haptics, for positioning the intraocular lens within the eye.

[0030] In some embodiments, the implant section 110 may additionally or alternatively be configured to prepare the implant 125 for delivery. For example, some embodiments of the implant section 110 may be configured to be actuated by a surgeon or other operator to prepare the implant 125 for delivery by subsequent actuation of the actuator 115. In some cases, the implant section 110 may be configured to actively deform, stretch, expand, or otherwise manipulate features of the implant 125 prior to advancing the implant 125 into the nozzle 105. For example, some embodiments of the implant section 110 may be configured to orient or collapse the implant. For example, the implant 125 may include one or more supports that may be oriented for delivery.

[0031] The plunger 135 is generally configured to advance the implant 125 from the implant section 110 into the delivery lumen 120 of the nozzle 105. For example, when the drive coupling 210 is coupled to the first coupling 155, a force can be applied to the hydraulic driver 205 to move the hydraulic driver 205 and the plunger 135 within the housing 130 from a first configuration shown in the example of FIG. 2A to a second configuration shown in the example of FIG. 2B. In the embodiment of FIG. 2A, for example, the hydraulic driver 205 includes a flange 250, and pressure can be applied to the flange 250 to firmly move the hydraulic driver 205 and the plunger 135 to the second configuration while maintaining the relative position of the drive plunger 220 and the actuating fluid 215. As shown in the example of FIG. 2B, the implant 125 can also be advanced into the delivery lumen 120 of the nozzle 105 by the implant interface 170. In the second configuration, the nozzle seal 165 is also advanced into the delivery lumen 120 to create a seal behind the implant 125 within the delivery lumen 120. In some cases, the implant 125 may also form a seal with the delivery lumen 120. In the configuration of FIG. 2B , the bore 140 may fluidly couple the actuating fluid 215 in the hydraulic driver 205 to the delivery lumen 120.

[0032] The drive coupling 210 can engage with the second coupling 160 of the actuator 115 to hold the drive coupling 210 in a fixed position relative to the housing 130. For example, as shown in FIG. 2C , the drive coupling 210 can be inserted into the second coupling 160 to hold the drive coupling 210 against further forces applied to the hydraulic driver 205. In some embodiments, the second coupling 160 can include a screw capture configured to engage the threads 230 of the drive coupling 210 to prevent further linear movement of the drive coupling 210. A suitable screw capture can include internal threads, teeth, or a ratchet system configured to allow one-way insertion of the screw 230 into the second coupling 160 and prevent further linear movement of the drive coupling 210 once inserted into the second coupling 160.

[0033] 2C to force the working fluid 215 through the bore 140 and into the delivery lumen 120 behind the implant 125. The movement of the working fluid 215 from the bore 140 to the delivery lumen 120 under pressure by 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, thereby advancing the implant 125 further within the delivery lumen 120 until the implant 125 is expelled from the nozzle 105.

[0034] 3A-3B are schematic diagrams further illustrating an exemplary use of the system 100 for delivering an implant 125 to an eye 300. As shown, an incision 305 may be made in the eye 300, for example, by a surgeon. In some cases, the incision 305 may be made through the sclera 310 of the eye 300. In other examples, the incision may be formed in the cornea 315 of the eye 300. The incision 305 may be sized to allow for insertion of a portion of the nozzle 105 to deliver the implant 125 to the lens capsule 320. For example, in some cases, the size of the incision 305 may have a length of less than about 3000 microns (3 millimeters). In other examples, the incision 305 may have a length of about 1000 microns to about 1500 microns, about 1500 microns to about 2000 microns, about 2000 microns to about 2500 microns, or about 2500 microns to about 3000 microns.

[0035] After creating the incision 305, the nozzle 105 can be inserted through the incision 305 into the interior portion 325 of the eye 300. The system 100 can then eject the implant 125 through the nozzle 105 and 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 can be delivered in a folded configuration and can return to an initial, expanded state within the capsular bag 320, as shown in FIG. 3B. In the example of FIGS. 3A and 3B, the implant 125 illustrates an intraocular lens having an optic 330, anterior haptics 335, and posterior haptics 340. For example, the implant 125 can be in the form of an accommodating intraocular lens having one or more of the fluid-filled optic 330, anterior haptics 335, and posterior haptics 340. The capsule 320 can hold the implant 125 within the eye 300 in a relationship relative to the eye 300 such that the optic 330 refracts light directed toward the retina (not shown). The anterior haptic 335 and posterior haptic 340 can engage the capsule 320 to secure the implant 125 therein. After providing the implant 125 within the capsule 320, the nozzle 105 can be removed from the eye 300 through the incision 305, and the eye 300 can be allowed a period of time to heal.

[0036] The systems, devices, and methods described herein may offer significant advantages. For example, some embodiments may be particularly advantageous for delivering intraocular lenses, including fluid-filled accommodating lenses, which can present unique delivery challenges. Some embodiments can compress relatively large lenses to fit through acceptably small incisions, manage deformations caused by fluid movement during compression and ejection from the nozzle, and perform delivery in a predictable and controlled manner. Furthermore, some embodiments can reduce system complexity and the number of delivery steps while maintaining consistency in haptic positioning. Some embodiments can also reduce the amount of working fluid required for delivery. For example, a single vial of ophthalmic viscoelastic device (OVD), such as a vial of CELLUGEL OVD, may be used to power some embodiments of the system 100 and provide the working fluid for delivery.

[0037] While shown in several exemplary embodiments, those skilled in the art will recognize that the systems, devices, and methods described herein are capable of various modifications and variations that fall within the scope of the appended claims. Furthermore, the use of terms such as "or" to describe various alternatives does not require mutual exclusivity unless the context clearly requires otherwise, and the indefinite articles "a" or "an" do not limit subject matter to a single example unless the context clearly requires otherwise. Components may also be combined or excluded in various configurations for purposes of sale, manufacture, assembly, or use. For example, in some configurations, the nozzle 105, implant segment 110, and actuator 115 may be separated from one another or combined in various ways for purposes of manufacture or sale, respectively.

[0038] The claims may encompass additional subject matter not specifically described. For example, certain features, elements, or aspects may be omitted from the claims if they are not necessary to distinguish new and inventive features from those already known to those skilled in the art. Features, elements, and aspects described in connection with 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 as defined by the appended claims.

Claims

1. 1. An apparatus for ophthalmic surgery, comprising: a nozzle having a delivery lumen; an implant segment coupled to the nozzle; an implant disposed within the implant compartment; an actuator coupled to the implant section, the actuator comprising: Housing and a plunger disposed within the housing, the plunger having a first end and a second end; a bore through said plunger; a first coupling proximate the first end; a second coupling integrated into the housing; Including, the bore is fluidly coupled to the implant segment, the first coupling is configured to receive a hydraulic driver and fluidly couple actuation fluid within the hydraulic driver to the bore, and a portion of the plunger is slidingly disposed within the second coupling. An actuator; Including, The apparatus further includes a nozzle seal disposed adjacent the second end of the plunger.

2. The apparatus of claim 1 , wherein the second coupling is configured to hold a drive coupling of the hydraulic driver in a fixed position relative to the housing.

3. The apparatus of claim 2 , wherein the second coupling includes a screw capture configured to engage the drive coupling.

4. The apparatus of claim 3 , wherein the screw capture includes internal threads configured to receive external threads on the drive coupling.

5. The device of claim 3 , wherein the screw capture includes teeth.

6. The device of claim 3 , wherein the screw capture includes a ratchet system.

7. The device of any one of claims 1 to 6, further comprising an implant interface coupled to the second end of the plunger and configured to engage the implant.

8. The apparatus of claim 7 , wherein the implant interface extends into the implant compartment.

9. 1. An apparatus for advancing a lens within an implant delivery system, comprising: a housing configured to be coupled to the implant section; a plunger disposed within the housing, the plunger having a first end and a second end; a bore extending longitudinally through the plunger from the first end to the second end; a first coupling proximate the first end; a second coupling integrated into the housing; Including, the bore configured to be fluidly coupled to the implant segment, the first coupling configured to receive a hydraulic driver and fluidly couple an actuating fluid in the hydraulic driver to the bore, a portion of the plunger slidingly disposed within the second coupling, and the second end of the plunger configured to engage the lens; The apparatus further includes a nozzle seal disposed adjacent the second end of the plunger.

10. 10. The apparatus of claim 9, wherein the second coupling is configured to hold a drive coupling of the hydraulic driver in a fixed position relative to the housing.

11. The apparatus of claim 10 , wherein the second coupling includes a screw capture configured to engage the drive coupling.

12. The apparatus of claim 11 , wherein the screw capture includes internal threads configured to receive external threads on the drive coupling.

13. The device of claim 11 , wherein the screw capture includes teeth.

14. The device of claim 11 , wherein the screw capture includes a ratchet system.

15. The device of any one of claims 9 to 14, further comprising an implant interface coupled to the second end of the plunger and configured to engage the lens.

16. The apparatus of claim 15 , wherein the implant interface is configured to extend into the implant compartment.

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