Hydraulic delivery of surgical implants

Abstract

An apparatus for eye surgery can include a nozzle having a delivery lumen, an implant pod coupled with the nozzle, an implant disposed in the implant pod, and an actuator coupled with the implant pod. The actuator can 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 with the housing. The bore can be fluidically coupled with the implant pod. The first coupling can be configured to receive a hydraulic driver and fluidically couple working fluid in the hydraulic driver to the bore. A portion of the plunger can be disposed to slide through the second coupling. In some embodiments, the second coupling can be configured to hold a drive coupling of the hydraulic driver in a fixed position relative to the housing.

Description

[0001] Priority Statement

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 112,692, filed November 12, 2020, entitled “HYDRAULICDELIVERY OF SURGICAL IMPLANTS”, inventors Todd Taber, Kathryn Jensen, Jestwin Edwin Lee, IV, Pradeep Magadum, and Saumya Dilip Yadav, which is incorporated herein by reference in its entirety as fully and completely set forth herein. Technical Field

[0003] The invention set forth in the appended claims generally relates to eye surgery. More specifically, but not limitingly, the claimed subject matter relates to systems, devices, and methods for inserting implants into the eye. Background Technology

[0004] The human eye can be affected by a variety of conditions, ranging from mild vision loss to complete blindness. While contact lenses and eyeglasses can compensate for some conditions, others may require eye surgery. In some cases, implants can be beneficial or necessary. For example, an artificial lens can replace the cloudy natural lens inside the eye to improve vision.

[0005] While the benefits of intraocular lenses and other implants are well-known, improvements in delivery systems, components, and manufacturing processes will continue to enhance efficacy and benefit patients. Summary of the Invention

[0006] The appended claims set forth novel and useful systems, apparatus, and methods for eye surgery. Illustrative embodiments are also provided to enable those skilled in the art to implement and apply the claimed subject matter.

[0007] For example, some embodiments may include, or substantially consist of, a device for delivering implants such as intraocular lenses using hydraulic pressure or fluid flow. This device may be combined with a disposable hydraulic actuator (such as a vial of working fluid) to provide a fully disposable system for storing, advancing, and delivering implants. 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 through-hole of the rigid plunger that allows the working fluid to advance the implant into the eye via hydraulic pressure in a second stage. For example, a straight-line intraocular lens may first be advanced into a delivery lumen to form a seal around the lens using a hollow rigid plunger. The lens can then be hydraulically advanced for delivery by allowing working fluid to pass through the hollow hole 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 with the shoulder of the optical body of the lens and advancing the lens into the delivery lumen. The device may additionally include a plunger stop that can be configured to stop the advancement of the implant interface or plunger.

[0008] In other, more specific embodiments, a vial of working fluid can be used as a hydraulic actuator to advance and deliver an intraocular lens in a delivery system. For example, the vial can be connected to the back of a plunger in the delivery system via a Luer lock. The delivery system can straighten one or more loops of the lens (e.g., the anterior loop) and prepare the lens for advancement. The vial can be advanced forward, thereby advancing the plunger and lens to a second position where the end of the vial engages with a coupling in the delivery system. This coupling prevents removal of the vial. For example, the vial can have external threads, and the coupling can have internal threads configured to receive the external threads of the vial. The vial can have a second plunger that can be pressed to expel the working fluid from the vial and through a hole in the plunger of the delivery system to eject the lens from the delivery system.

[0009] More generally, a device for advancing an implant in an implant delivery system may include a housing, a plunger disposed within the housing, an orifice extending through the plunger from a first end to a second end, a first coupling proximate to the first end, and a second coupling integral with the housing. The orifice may be configured to fluidly connect to an implant capsule. The first coupling may be configured to receive a hydraulic actuator and fluidly connect working fluid from the hydraulic actuator to the orifice. A portion of the plunger may be configured to slide through the second coupling, and a 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 actuator in a fixed position relative to the housing. In more specific embodiments, the second coupling may include or substantially consist of a thread catcher configured to engage the drive coupling.

[0010] In other embodiments, an apparatus for ocular surgery may include a nozzle having a delivery lumen, an implant capsule coupled to the nozzle, an implant disposed in the implant capsule, and an actuator coupled to the implant capsule. The actuator may include a housing, a plunger disposed within the housing, an orifice through the plunger, a first coupling near a first end of the plunger, and a second coupling integral with the housing. The orifice may be fluidly coupled to the implant capsule. The first coupling may be configured to receive a hydraulic actuator and fluidly coupled to the orifice with working fluid from the hydraulic actuator. A portion of the plunger may be configured to slide through the second coupling. In some embodiments, the second coupling may be configured to hold a drive coupling of the hydraulic actuator in a fixed position relative to the housing. In a more specific embodiment, the second coupling may include or substantially consist of a thread catcher configured to engage the drive coupling.

[0011] A method of ejecting an implant from an implant delivery system may include placing the implant in an implant chamber. In some examples, the implant may be a lens, such as an intraocular lens. A hydraulic actuator may be coupled to a rigid plunger of the implant delivery system, and the hydraulic actuator may drive the rigid plunger to advance the implant from the implant chamber 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. Working fluid in the hydraulic actuator may be actuated to pass through an orifice in the rigid plunger to the delivery lumen, and the working fluid may advance the implant through the delivery lumen.

[0012] This embodiment may be particularly advantageous for the delivery of intraocular lenses, including adjustable lenses, which can present unique delivery challenges. Some embodiments may manage the fluid within the adjustable lens to compress the relatively large lens for advancement through an acceptable small incision, handle deformation caused by fluid transfer during compression and exit from the nozzle, and implement delivery in a predictable and controlled manner. The intraocular lens may additionally include one or more loops capable of extending radially to hold the lens within the eye. Some embodiments may reduce system complexity and the number of delivery steps while maintaining loop position consistency. Some embodiments may also reduce the amount of working fluid used for delivery.

[0013] The features, elements, and aspects described in the context of some embodiments may be omitted, combined, or replaced by alternative features. Other features, objects, advantages, and preferred modes for implementing and applying the claimed subject matter are described in more detail below with reference to the accompanying drawings of illustrative embodiments. Attached Figure Description

[0014] The accompanying drawings illustrate some objects, advantages, and preferred modes of implementing and applying the claimed subject matter. In the examples, the same reference numerals denote the same parts.

[0015] Figure 1 This is a schematic diagram of an example system for inserting an implant into the eye.

[0016] Figures 2A to 2C It is a demonstration Figure 1 A schematic diagram illustrating the operation of the example system.

[0017] Figures 3A to 3B It is a demonstration Figure 1 A schematic diagram illustrating an example application of the system that inserts an implant into the eye. Detailed Implementation

[0018] The following description of exemplary embodiments provides information that enables those skilled in the art to implement and apply the subject matter set forth in the appended claims, but some details well known in the art may be omitted. Therefore, the following detailed description should be regarded as illustrative rather than restrictive.

[0019] This document may also describe exemplary embodiments with reference to the spatial relationships or spatial orientations of the various elements depicted in the accompanying drawings. Typically, such relationships or orientations employ a frame of reference consistent with or relevant to a patient in the appropriate position to receive the implant. However, as those skilled in the art will recognize, such a frame of reference is merely descriptive and not a strict specification.

[0020] Figure 1 This is a schematic diagram of a system 100 that can be used to deliver an implant into the eye. For example, as... Figure 1 As shown, some embodiments of system 100 may include a nozzle 105, an implantation capsule 110 that can be coupled to the nozzle 105, and an actuator 115 that can be coupled to the implantation capsule 110.

[0021] Typically, the components of system 100 can be directly or indirectly connected. For example, nozzle 105 can be directly connected to implant capsule 110 and indirectly connected to actuator 115 via implant capsule 110. Connections can include fluid connections, mechanical connections, thermal connections, electrical connections, or chemical connections (such as chemical bonds), or combinations thereof in certain situations. For example, actuator 115 can be fluidly mechanically connected to nozzle 105. In some embodiments, components can also be connected by physical proximity, integration into a single structure, or formation from the same material.

[0022] The nozzle 105 typically includes a tip adapted for insertion into the eye through an incision. The size of the tip can be adapted to the requirements and techniques of the surgical procedure. For example, small incisions are generally preferred to reduce or minimize healing time. In some cases, an incision of less than 3 mm may be preferred, and in some embodiments, the width of the tip of the nozzle 105 may be less than 3 mm. Figure 1 The nozzle 105 has a delivery lumen 120.

[0023] Implant compartment 110 typically represents a variety of different devices suitable for storing implants before delivery into the eye. For example, in Figure 1 The implant 125 is placed inside the implant compartment 110.

[0024] Figure 1 The actuator 115 typically includes a housing 130, a plunger 135 disposed within the housing 130, and a bore 140 penetrating the plunger 135. The plunger 135 is typically made of a substantially rigid material, such as a medical-grade polymer. The bore 140 typically extends longitudinally through the plunger 135 from a first end 145 to a second end 150. The actuator 115 may additionally include a first coupling 155 adjacent to 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 configured to slide through the second coupling 160.

[0025] In some embodiments, actuator 115 may additionally include nozzle seal 165. For example... Figure 1 As shown in the example, the nozzle seal 165 may be an annular seal, such as an O-ring, disposed circumferentially around a portion of the plunger 135. In other examples, an umbrella-shaped seal may be applicable. In a more specific embodiment, the nozzle seal 165 may be disposed near the second end 150 of the plunger 135.

[0026] Some embodiments of the actuator 115 may also include an implant interface 170. For example, in some embodiments, Figure 1 The implant interface 170 can be connected to the second end 150 of the plunger 135.

[0027] Some embodiments of system 100 may additionally include a variety of different ergonomic features. For example, Figure 1 The system 100 has a finger flange 175 connected to the actuator 115, which can facilitate one-handed operation of the system 100.

[0028] Figures 2A to 2C It is a demonstration Figure 1 A schematic diagram illustrating the operation of system 100. Initially, multiple different components of system 100 can be assembled if needed. Figures 2A to 2CIn one example, the nozzle 105, implant compartment 110, and actuator 115 are fixed together to form an integral structure. In other embodiments, system 100 may include two or more modules that can be configured to be coupled and discoupled as needed for storage, assembly, use, and disposal.

[0029] In such Figure 2A In the assembled configuration shown, the implant compartment 110 can be positioned between the orifice 140 and the delivery lumen 120. A portion of the plunger 135 and the implant interface 170 can extend into the implant compartment 110, and the implant interface 170 can be configured to engage the implant 125.

[0030] exist Figure 2A In the example, system 100 is configured to receive hydraulic actuator 205. Figure 2A The hydraulic actuator 205 typically includes a drive coupling 210, a working fluid 215, and a drive plunger 220. In some embodiments, the hydraulic actuator 205 may include or consist substantially of a vial of working fluid. Suitable working fluids may include, but are not limited to, liquids such as brine or viscous lubricants with non-Newtonian properties.

[0031] The first coupling 155 of the actuator 115 may be configured to receive the hydraulic actuator 205 and fluidly connect the working fluid 215 in the hydraulic actuator 205 to the bore 140. For example, the drive coupling 210 may be configured to engage with the first coupling 155 of the actuator 115. In some embodiments, the first coupling 155 may be a Luer lock, a Luer slide, or a 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, while 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 additionally include external threads 230.

[0032] Implant 125 can be placed in implant compartment 110, such as Figure 2A As illustrated in the examples. In some embodiments, implant 125 may include an artificial lens with a shape similar to the natural lens of the eye and may be made of a variety of materials. Examples of suitable materials may include silicone, acrylic materials, and combinations of these suitable materials. In some cases, implant 125 may include a fluid-filled artificial lens, such as a fluid-filled adjustable artificial lens. Implant 125 may also include an artificial lens that includes one or more features, such as a loop, for positioning the artificial lens within the eye.

[0033] In some embodiments, the implant capsule 110 may be additionally or alternatively configured to prepare the implant 125 for delivery. For example, some embodiments of the implant capsule 110 may be configured to be actuated by a surgeon or other operator to prepare the implant 125 for delivery via subsequent action of the actuator 115. In some cases, the implant capsule 110 may be configured to actively deform, elongate, extend, or otherwise manipulate features of the implant 125 prior to its advancement into the nozzle 105. For example, some embodiments of the implant capsule 110 may be configured to orient or fold the implant. For example, the implant 125 may include one or more loops that can be oriented for delivery.

[0034] The plunger 135 is typically configured to advance the implant 125 from the implant chamber 110 into the delivery lumen 120 of the nozzle 105. For example, with the drive coupling 210 engaged with the first coupling 155, force can be applied to the hydraulic actuator 205 to cause the hydraulic actuator 205 and the plunger 135 to move within the housing 130 from... Figure 2A The example shown shows the first configuration moved as follows Figure 2B The example shows the second configuration. For example, in Figure 2A In one embodiment, the hydraulic actuator 205 includes a flange 250, and a force can be applied to the flange 250 to rigidly move the hydraulic actuator 205 and the plunger 135 into a second configuration while maintaining the relative positions of the drive plunger 220 and the working fluid 215. Figure 2B As shown in the example, the implant 125 can also be advanced through the implant interface 170 into the delivery lumen 120 of the nozzle 105. In the second configuration, the nozzle seal 165 is also advanced into the delivery lumen 120 to form a seal in the delivery lumen 120 behind the implant 125. In some cases, the implant 125 can also form a seal with the delivery lumen 120. Figure 2B In this configuration, the orifice 140 allows the working fluid 215 in the hydraulic actuator 205 to be fluidly connected to the delivery cavity 120.

[0035] 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 Figure 2CAs shown, drive coupling 210 can be inserted into second coupling 160 to retain drive coupling 210 against another force applied to hydraulic actuator 205. In some embodiments, second coupling 160 may include a thread catcher configured to engage with thread 230 of drive coupling 210 to prevent further linear movement of drive coupling 210. Suitable thread catchers may include internal threads, teeth, or ratchet systems configured to allow unidirectional insertion of thread 230 into second coupling 160, preventing further linear movement of drive coupling 210 once inserted.

[0036] While maintaining the drive coupling 210, the drive plunger 220 can be advanced to the third configuration, such as... Figure 2C As shown, the working fluid 215 is forced through the orifice 140 into the delivery lumen 120 behind the implant 125. The movement of the working fluid 215 from the orifice 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, thus propelling the implant 125 further through the delivery lumen 120 until the implant 125 is ejected from the nozzle 105.

[0037] Figures 3A to 3B This is a schematic diagram further illustrating an example application of system 100 delivering implant 125 to eye 300. As shown, for example, a surgeon may create an incision 305 in eye 300. In some cases, incision 305 may penetrate the sclera 310 of eye 300. In other cases, an incision may be created in the cornea 315 of eye 300. The size of incision 305 may be set to allow a portion of nozzle 105 to be inserted to deliver implant 125 into capsular bag 320. For example, in some cases, the length of incision 305 may be less than about 3000 micrometers (3 millimeters). In other cases, the length of incision 305 may be from about 1000 micrometers to about 1500 micrometers, from about 1500 micrometers to about 2000 micrometers, from about 2000 micrometers to about 2500 micrometers, or from about 2500 micrometers to about 3000 micrometers.

[0038] After incision 305 is made, nozzle 105 can be inserted through incision 305 into the internal portion 325 of eye 300. Then, system 100 can push implant 125 into capsular bag 320 of eye 300 through nozzle 105, essentially as described above. Figures 2A to 2C As described above. In some applications, the implant 125 can be delivered in a folded configuration and can return to its initial unfolded state within the pouch 320, such as... Figure 3B As shown. In Figure 3A and Figure 3BIn the example, implant 125 is an example of an intraocular lens having an optical body 330, an anterior loop 335, and a posterior loop 340. For example, implant 125 may be in the form of a fluid-filled adjustable intraocular lens having one or more of the optical body 330, anterior loop 335, and posterior loop 340. Capsule 320 holds implant 125 within eye 300, its relationship to eye 300 such that optical body 330 refracts light to the retina (not shown). Anterior loop 335 and posterior loop 340 may engage with capsule 320 to secure implant 125 therein. After implant 125 is dispensed into capsule 320, nozzle 105 can be removed from eye 300 through incision 305, allowing eye 300 to heal over time.

[0039] The systems, apparatus, and methods described herein can offer significant advantages. For example, some embodiments may be particularly advantageous for the delivery of intraocular lenses, including fluid-filled adjustable lenses, which can present unique delivery challenges. Some embodiments can compress relatively large lenses to accommodate deformation caused by transferred fluid during compression and exit from the nozzle via an acceptable small incision, and deliver the lenses in a predictable and controlled manner. Additionally, some embodiments can reduce system complexity and the number of delivery steps while maintaining loop position consistency. Some embodiments can also reduce the amount of working fluid used for delivery. For example, a single-bottle ophthalmic adhesive surgical device (OVD), such as a small vial of CELLUGEL OVD, can be used to drive some embodiments of system 100 and provide working fluid for delivery.

[0040] Although shown only in a few illustrative embodiments, those skilled in the art will recognize that the systems, devices, and methods described herein are readily adaptable to a variety of different changes and modifications falling within the scope of the appended claims. Furthermore, descriptions of multiple different alternatives using terms such as “or” are not required to be mutually exclusive unless the context explicitly requires it, and the indefinite article “a / an” does not limit the subject matter to a single instance unless the context explicitly requires it. The components may also be combined or removed in a variety of different configurations for purposes of sale, manufacture, assembly, or use. For example, in some configurations, the nozzle 105, implant capsule 110, and actuator 115 may each be separate from each other or combined in a variety of different ways for manufacture or sale.

[0041] The claims may also cover additional subject matter not specifically detailed. For example, certain features, elements, or aspects may be omitted from the claims if it is not necessary to distinguish novel and inventive features from those 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 for the same, equivalent, or similar purposes without departing from the scope of the invention as defined by the appended claims.

Claims

1. A device for eye surgery, the device comprising: A nozzle having a delivery lumen; An implant capsule, which is connected to the nozzle; An implant disposed in the implant capsule; as well as An actuator, coupled to the implant capsule, the actuator comprising: case; A plunger disposed within the housing has a first end and a second end, and a nozzle seal disposed near the second end. The hole penetrating the plunger, The first connector near the first end, and The second connecting member is integral with the housing; The orifice is fluidly connected to the implant chamber, the first coupling is configured to receive a hydraulic actuator and fluidly connect the working fluid in the hydraulic actuator to the orifice, and a portion of the plunger is configured to slide through the second coupling.

2. The device as claimed in claim 1, wherein, The second coupling is configured to hold the drive coupling of the hydraulic actuator in a fixed position relative to the housing.

3. The device as described in claim 2, wherein, The second coupling includes a thread catcher configured to engage the drive coupling.

4. The device as described in claim 3, wherein, The thread catcher includes an internal thread configured to receive an external thread on the drive coupling.

5. The device as described in claim 3, wherein, The thread catcher includes teeth.

6. The device as claimed in claim 3, wherein, The thread catcher includes a ratchet system.

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

8. The device as claimed in claim 7, wherein, The implant interface extends into the implant compartment.

9. An apparatus for advancing a lens in an implant delivery system, the apparatus comprising: A housing configured to be attached to an implant compartment; A plunger disposed within the housing, the plunger having a first end and a second end, and a nozzle seal disposed near the second end; A hole, which extends longitudinally through the plunger from the first end to the second end; A first connecting member, the first connecting member being close to the first end; as well as The second connecting member is integral with the housing; The orifice is configured to be fluidly connected to the implant chamber, the first coupling is configured to receive a hydraulic actuator and fluidly connect working fluid in the hydraulic actuator to the orifice, a portion of the plunger is configured to slide through the second coupling, and a second end of the plunger is configured to engage the lens.

10. The device as claimed in claim 9, wherein, The second coupling is configured to hold the drive coupling of the hydraulic actuator in a fixed position relative to the housing.

11. The device as claimed in claim 10, wherein, The second coupling includes a thread catcher configured to engage the drive coupling.

12. The device as claimed in claim 11, wherein, The thread catcher includes an internal thread configured to receive an external thread on the drive coupling.

13. The device as claimed in claim 11, wherein, The thread catcher includes teeth.

14. The device as claimed in claim 11, wherein, The thread catcher includes a ratchet system.

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

16. The device as claimed in claim 15, wherein, The implant interface is configured to extend into the implant compartment.

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