Ratchet drive delivery of surgical implants

Abstract

An apparatus for delivering an implant to an eye using a ratchet drive. Some embodiments of the apparatus for delivering an implant to an eye may include a gear rack configured to be coupled to the implant, a forward gear wheel, an input gear wheel meshed with the forward gear wheel, an idler gear wheel meshed with the input gear wheel, and a reverse gear wheel meshed with the idler gear wheel. The actuation lever may be configured to rotate the input gear wheel. Some embodiments may further include a pivot arm operable to selectively engage the forward gear wheel and the reverse gear wheel with the gear rack.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 143,091, filed Jan. 29, 2021, entitled “RATCHET DRIVE DELIVERY FOR SURGICAL IMPLANTS” by inventor R. Mitchell Sherry, which is hereby incorporated by reference in its entirety as if fully and completely set forth herein.

[0002] The invention described in the appended claims generally relates to ophthalmic surgery. More particularly, without limitation, the claimed subject matter relates to systems, devices, and methods for implanting an implant into an eye.

Background Art

[0003] The human eye is susceptible to many diseases that can cause anything from mild deterioration to complete loss of vision. Contact lenses and glasses can compensate for some diseases, but in other cases, ophthalmic surgery may be required. In some instances, implants may be beneficial or desirable. For example, an intraocular lens can replace a cloudy natural lens within the eye and improve vision.

[0004] Although the advantages of intraocular lenses and other implants are known, improvements in delivery systems, components, and processes continue to be made to improve the results and benefit patients.

Summary of the Invention

Means for Solving the Problems

[0005] The appended claims describe novel and useful systems, devices, and methods for ophthalmic surgery. Exemplary embodiments are also provided to enable one of ordinary skill in the art to make and use the claimed subject matter.

[0006] Several embodiments may provide a reusable or disposable, manually operated, one-handed delivery device capable of smoothly and reliably driving a plunger or other type of push rod. For example, an exemplary device may include a gear drive mechanism that can be driven by a lever-operated ratchet mechanism. Some embodiments may incorporate, among other things, a drive gear and a driven gear, an idler gear, an operating lever, a drive pawl and an anti-retraction pawl, a spring for returning the lever to its starting position, and a forward / retraction switch. In some embodiments, the lever may be manually operated by the index finger of either hand.

[0007] In more specific examples, the delivery device may include a gear assembly mounted on a pivot plate, a lever, and a ratchet that generates linear motion of the gear rack. This linear motion drives a plunger or rod to advance the implant. In some embodiments, the device can be connected to an implant to prepare it for delivery. For example, the plunger may fold the implant before advancing it into the eye. The gear mechanism may include a drive gear that meshes with a forward gear and an idler gear. The idler gear may, in turn, mesh with a retraction gear. The lever may interact with the ratchet mechanism to rotate the drive gear, ensuring reliable unidirectional drive during operation. A drive pawl and an optional anti-retraction pawl can control the ratchet. A spring may be used to return the lever to its starting position when released. In some embodiments, a manual switch can determine the direction of movement (i.e., forward or backward) by rotating the pivot plate so that the intended gear engages with the gear rack.

[0008] More generally, some embodiments of a device for delivering an implant to the eye may include a gear rack configured to be coupled to the implant, a forward gear wheel, an input gear wheel meshed with the forward gear wheel, an idler gear wheel meshed with the input gear wheel, and a receding gear wheel meshed with the idler gear wheel. An operating lever may be configured to rotate the input gear wheel, thereby moving the gear rack to the other gears. Some embodiments may further include a pivot arm that can be operated to selectively engage the forward and receding gear wheels with the gear rack.

[0009] In further specific embodiments, the device may include a ratchet wheel coupled to an actuating lever and an input gear wheel. The ratchet wheel may be configured to allow the actuating lever to rotate the input gear wheel in only one direction. In some embodiments, an input shaft can be coupled to the actuating lever and the input gear wheel, and a pivot arm is pivotable about the input shaft. For example, the pivot arm is operable to rotate between a first position and a second position. In the first position, the forward gear wheel can be engaged with the gear rack, and in the second position, the reverse gear wheel can be engaged with the gear rack. Some embodiments may include a spring configured to return the pivot arm to the first position.

[0010] Further specific embodiments may further include a nozzle having a delivery lumen, an implant compartment coupled to the nozzle, and a push rod configured to couple a gear rack to an implant within the implant compartment. The push rod may also be configured to advance the implant into the delivery lumen.

[0011] Features, elements, and aspects described in relation to some embodiments may also be omitted, combined, or replaced with alternative features. Other features, purposes, advantages, and preferred modes of constructing and using the claimed subject matter will be described in more detail below with reference to the accompanying drawings of exemplary embodiments.

[0012] The attached drawings illustrate preferred modes of fabricating and using some of the purposes, advantages, and embodiments of the claims. In the examples, similar reference numerals represent similar parts. [Brief explanation of the drawing]

[0013] [Figure 1] Figure 1 is an isometric view of an exemplary device for delivering an implant to the eye. [Figure 2] Figure 2 is an isometric view of a portion of the exemplary apparatus shown in Figure 1, illustrating additional details of the drive assembly that may be associated with several embodiments. [Figure 3] Figure 3 is another isometric view of a portion of the exemplary apparatus shown in Figure 1, illustrating additional details that may be relevant to several embodiments of the drive assembly. [Figure 4A] Figure 4A is a rear view of the drive assembly shown in Figure 3. [Figure 4B] Figure 4B is a rear view of the drive assembly shown in Figure 3. [Figure 5A-5B] Figures 5A and 5B are schematic diagrams illustrating an exemplary method for removing the implant from the apparatus shown in Figure 1. [Figure 6A-6B] Figures 6A and 6B are schematic diagrams illustrating an exemplary application of the device shown in Figure 1 for implantation in the eye. [Modes for carrying out the invention]

[0014] The following description of exemplary embodiments provides information that will enable those skilled in the art to manufacture and use the subject matter described in the appended claims, although certain details already known in the art may be omitted. Therefore, the following detailed description is illustrative and not limiting.

[0015] Exemplary embodiments may also be described herein by reference to the spatial relationships between various elements or the spatial orientation of various elements depicted in the accompanying drawings. Generally, such relationships or orientations assume a coordinate system that coincides with or is relative to a patient in an implant-receiving position. However, as will be understood by those skilled in the art, this coordinate system is not a strict definition but merely a descriptive convenience.

[0016] Figure 1 is an isometric view of an example of a device 100 capable of delivering an implant to the eye. In some embodiments, the device 100 may include two or more modules, which may be configured to be joined and separated as appropriate for storage, assembly, use, and disposal. For example, as shown in Figure 1, some embodiments of the device 100 may include a nozzle 105, an implant compartment 110 coupled to the nozzle 105, and an actuator 115 coupled to the implant compartment 110.

[0017] The nozzle 105 generally includes a tip 120 adapted for insertion into the eye through an incision. The size of the tip 120 can be adapted to surgical requirements and techniques as needed. For example, a small incision is generally preferred to shorten or minimize healing time. In some examples, an incision of less than 3 millimeters may be preferred, and in some embodiments, the tip 120 of the nozzle 105 may have a width of less than 3 millimeters.

[0018] The implant compartment 110 generally represents a variety of devices suitable for housing an implant before intraocular delivery. In some embodiments, the implant compartment 110 may be configured to additionally or alternatively prepare the implant for delivery. For example, some embodiments of the implant compartment 110 may be configured to be actuated by a surgeon or other operator to prepare the implant for delivery by subsequent operation of the actuator 115. In some examples, the implant compartment 110 may be configured to actively deform, extend, expand, or otherwise manipulate features of the implant before advancing the implant into the nozzle 105. For example, the implant compartment 110 may be configured to extend or widen one or more features, such as a support for an intraocular lens.

[0019] The actuator 115 is generally configured to advance the implant from the implant compartment 110 to the nozzle 105, and then from the nozzle 105 through the incision into the eye. In the example in Figure 1, the actuator 115 further includes a housing 125, an actuating lever 130, and a rocker switch 135. The actuating lever 130 and the rocker switch 135 may be configured to allow an operator to manually operate the actuator 115. In some embodiments, the actuator 115 may further include a return spring 140 which can be coupled to the actuating lever 130 and the housing 125.

[0020] In general, the components of the device 100 can be coupled directly or indirectly. For example, the nozzle 105 can be directly coupled to the implant compartment 110, or indirectly coupled to the actuator 115 via the implant compartment 110. The coupling may include fluid, mechanical, thermal, electrical, or chemical coupling (such as chemical adhesion), or in some situations, some combination of couplings. For example, the implant compartment 110 can be mechanically coupled to the actuator 115, or mechanically and fluidly coupled to the nozzle 105. In some embodiments, components may also be coupled by physical proximity, integration into a single structure, or formation from the same material piece.

[0021] Figure 2 is an isometric view of the device 100 of FIG. 1 with a portion of the housing 125 removed, showing additional details that may be associated with some embodiments. As shown in the example of FIG. 2, in some embodiments, the housing 125 may house a push rod 205 and a drive assembly 210. The push rod 205 is generally composed of a substantially rigid material such as a medical grade polymer material. The housing 125 may at least partially support the drive assembly 210. For example, in FIG. 2, the drive assembly 210 includes an input shaft 215 that may be coupled to the housing 125 to support the drive assembly 210.

[0022] Figure 3 is an isometric view of the device 100 of FIG. 2 with the remaining portion of the housing 125 removed, showing additional details that may be associated with some embodiments of the drive assembly 210. As shown in the example of FIG. 3, some embodiments may include a gear rack 305, a forward gear wheel 310, an input gear wheel 315, an idler gear wheel 320, a reverse gear wheel 325, and a pivot arm 330.

[0023] The pivot arm 330 is pivotable or otherwise rotatable about the input shaft 215. In some embodiments, the pivot arm 330 may be rotatably attached to the input shaft 215. For example, the pivot arm 330 may be coupled to a rocker switch 135 that an operator can activate to rotate the pivot arm 330. A return spring 335 may be configured to return the pivot arm 330 when the rocker switch 135 is deactivated. For example, one end of the return spring 335 may be supported by the housing 125 (not shown), and the other end may be coupled to the pivot arm 330 as shown in FIG. 3. Thereby, a restoring force for rotating the pivot arm 330 to a stationary position can be provided.

[0024] Figures 4A and 4B are rear views of the drive assembly 210 of Figure 3 at different positions. As shown in the examples in Figures 4A and 4B, the forward gear wheel 310, idler gear wheel 320, and reversing gear wheel 325 may be rotatably mounted on a pivot arm 330. The pivot arm 330 may be capable of selectively engaging and disengaging the forward gear wheel 310 and the reversing gear wheel 325 with respect to the gear rack 305. For example, the pivot arm 330 may be rotatably mounted on an input shaft 215, and a rocker switch 135 may be actuated to rotate the pivot arm 330 around the input shaft 215 between a first position shown in Figure 4A and a second position shown in Figure 4B.

[0025] The input shaft 215 can be coupled to the input gear wheel 315 by the actuating lever 130. For example, as shown in Figures 4A and 4B, some embodiments of the drive assembly 210 may include a ratchet wheel 405 that indirectly couples the actuating lever 130 with the input gear wheel 315. In some embodiments, the ratchet wheel 405 may be indirectly coupled to the actuating lever 130 by a pawl 410. The ratchet wheel 405 may be configured to allow the actuating lever 130 to rotate the input gear wheel 315 in only one direction. For example, in Figures 4A and 4B, the input gear wheel 315 and the ratchet wheel 405 may be rigidly coupled to the input shaft 215 or otherwise rotatably mounted so that the input shaft 215, the input gear wheel 315, and the ratchet wheel 405 rotate simultaneously. Movement of the actuarial lever 130 in a first direction (downward in the examples of Figures 4A and 4B) can engage the pawl 410 with the asymmetric teeth on the ratchet wheel 405, thereby causing the ratchet wheel 405 to rotate in a first direction (clockwise in the examples of Figures 4A and 4B). In the examples of Figures 4A and 4B, the rotation of the ratchet wheel 405 in the first direction can also cause the input shaft 215 and the input gear wheel 315 to rotate in the first direction. Movement of the actuarial lever 130 in the opposite direction can cause the pawl 410 to slide on the asymmetric teeth on the ratchet wheel 405, thereby substantially reducing or preventing the opposite movement of the ratchet wheel 405, the input shaft 215, and the input gear wheel 315.

[0026] In Figure 4A, the pivot arm 330 is shown in a first position. In the first position in Figure 4A, the forward gear wheel 310 may mesh with or otherwise engage with the gear rack 305, and the input gear wheel 315 may mesh with the forward gear wheel 310. The idler gear wheel 320 may mesh with the input gear wheel 315, and the reverse gear wheel 325 may mesh with the idler gear wheel 320. The reverse gear wheel 325 is disengaged from the gear rack 305 in the first position of the pivot arm 330 shown in the example in Figure 4A.

[0027] With the pivot arm 330 in the first position shown in Figure 4A, the forward gear wheel 310 is engaged with the gear rack 305 and the reverse gear wheel 325 is disengaged. In this first position, movement of the operating lever 130 toward the forward gear wheel 310 (i.e., forward or downward in the orientation of Figure 4A) engages the pawl 410 with the ratchet wheel 405, rotating the ratchet wheel 405 in a first direction (i.e., clockwise in the orientation of Figure 4A), thereby rotating the input shaft 215 and the input gear wheel 315 in the same direction. The rotation of the input gear wheel 315 in the first direction simultaneously rotates the forward gear wheel 310 in the opposite direction (i.e., counterclockwise in the orientation of Figure 4A). The rotation of the forward gear wheel 310 in this direction while engaged with the gear rack 305, as in the example of Figure 4A, advances the gear rack 305 in the first direction (i.e., to the right in the orientation of Figure 4A). The movement of the actuation lever 130 can be reversed, and the actuation lever 130 can be reset as appropriate, allowing further forward movement of the gear rack 305. In the example in Figure 4A, the pawl 410 can slide over the teeth of the ratchet wheel 405 without causing rotation of the input shaft 215 when the actuation lever 130 moves in the reverse direction. In some embodiments, a return spring 140 can reverse and reset the actuation lever 130.

[0028] With the pivot arm 330 in the second position shown in Figure 4B, the forward gear wheel 310 is disengaged from the gear rack 305, and the reverse gear wheel 325 is engaged with the gear rack 305. In this second position, movement of the actuating lever 130 toward the forward gear wheel 310 engages the pawl 410 with the ratchet wheel 405, rotating the ratchet wheel 405 in the first direction, thereby rotating the input shaft 215 and the input gear wheel 315 in the same direction. The rotation of the input gear wheel 315 in the first direction simultaneously causes the idler gear wheel 320 to rotate in the opposite direction, thereby allowing the reverse gear wheel 325 to rotate in the same direction as the input gear wheel 315. Rotation of the reverse gear wheel 325 in this direction while engaged with the gear rack 305, as in the example in Figure 4B, causes the gear rack 305 to retract in the second direction, thereby reversing the direction of movement in the example in Figure 4A.

[0029] The return spring 335 can provide a restoring force to the pivot arm 330 to return the forward gear wheel 310 to the gear rack 305 and disengage the reverse gear wheel 325 when the rocker switch 135 is stopped.

[0030] Figures 5A and 5B are schematic diagrams illustrating an exemplary method for ejecting an implant 500 from the device 100. Initially, various components of the system may be assembled as needed or as appropriate. In the example shown in Figures 5A and 5B, the nozzle 105, the implant compartment 110, and the actuator 115 are fixed to each other to form a single structure. In other embodiments, the device 100 may include two or more modules, which may be configured to be joined and separated as appropriate for storage, assembly, use, and disposal.

[0031] As shown in the example in Figure 5A, the implant 500 may initially be housed within the implant compartment 110. The gear rack 305 may be configured to be coupled to the implant 500 within the implant compartment 110. For example, the gear rack 305 may be indirectly coupled to the implant 500 via a push rod 205. In other examples, the gear rack 305 may be configured to be directly coupled to the implant 500. As shown in the example in Figure 5A, at least a portion of the push rod 205 may extend into the implant compartment 110. In some embodiments, the push rod 205 may be configured to engage with the implant 500 within the implant compartment 110. In some embodiments, the implant 500 may include an intraocular lens having a shape similar to that of the natural lens of the eye and may be made from a number of materials. Examples of preferred materials include silicone, acrylic, and combinations of such preferred materials. In some examples, the implant 500 may include a fluid-filled intraocular lens, such as a fluid-filled accommodative intraocular lens. The implant 500 may also include an intraocular lens that includes one or more features for positioning the intraocular lens within the eye, such as a support.

[0032] In some embodiments, the implant compartment 110 may be configured to additionally or alternatively prepare the implant 500 for delivery. For example, some embodiments of the implant compartment 110 may be configured to be actuated by a surgeon or other operator to prepare the implant 500 for delivery by subsequent operation of the actuator 115. In some examples, the implant compartment 110 may be configured to actively deform, extend, expand, or otherwise manipulate the features of the implant 500 before advancing the implant 500 into the nozzle 105. For example, some embodiments of the implant compartment 110 may be configured to orient or fold the implant. Some embodiments of the implant 500 may include one or more supports that can be oriented for delivery.

[0033] The push rod 205 is generally configured to advance the implant 500 from the implant compartment 110 to the delivery lumen 505 of the nozzle 105. For example, if the advance gear wheel 310 is engaged with the gear rack 305, the gear rack 305 can advance substantially, as described with reference to Figure 4A, thereby advancing the push rod 205 from a first position shown in Figure 5A to a second position shown in Figure 5B. The advancement of the push rod 205 further advances the implant 500 from the implant compartment 110 to the delivery lumen 505, as shown.

[0034] Figures 6A and 6B are schematic diagrams further illustrating exemplary use of the device 100 for delivering an implant 500 into an eye 600. As shown, for example, an incision 605 may be made within the eye 600 by a surgeon. In some examples, the incision 605 may be made through the sclera 610 of the eye 600. In other examples, the incision may be formed in the cornea 615 of the eye 600. The incision 605 may be sized to allow insertion of a portion of the nozzle 105 to deliver the implant 500 into the lens capsule 620. For example, in some examples, the size of the incision 605 may be less than approximately 3000 microns (3 millimeters) in length. In other examples, the incision 605 may have a length of approximately 1000 to 1500 microns, approximately 1500 to 2000 microns, approximately 2000 to 2500 microns, or approximately 2500 to 3000 microns.

[0035] After the incision 605 is made, the nozzle 105 can be inserted through the incision 605 into the internal portion 625 of the eye 600. The device 100 can then discharge the implant 500 into the lens capsule 620 of the eye 600 through the nozzle 105, as substantially described with reference to Figures 5A and 5B. In the example of Figures 6A and 6B, the implant 500 exemplifies an intraocular lens having an optics 630, an anterior support 635, and a posterior support 640. In some applications, the implant 500 may be delivered in a linear configuration, as shown in Figure 6B, with one or both of the anterior support 635 and the posterior support 640 deployed, and can return to an initial resting state within the lens capsule 620, where the anterior support 635 and the posterior support 640 are at least partially curved around the optics 630. The lens capsule 620 can hold the implant 500 within the eye 600 in a relationship with the eye 600 such that the optical body 630 refracts light directed toward the retina (not shown). The anterior support 635 and posterior support 640 engage with the lens capsule 620 to fix the implant 500 within the lens capsule 620. After the implant 500 is delivered into the lens capsule 620, the nozzle 105 can be removed from the eye 600 through the incision 605, and the eye 600 can heal over a period of time.

[0036] The systems, apparatus, and methods described herein may offer significant advantages. For example, some embodiments may be particularly advantageous for delivering intraocular lenses. More specific advantages of some embodiments include facilitating one-handed operation, which allows the second hand to be free for other surgical instruments, thereby potentially reducing the number of staff required for the surgical procedure. Some embodiments can enhance delivery control and substantially reduce or eliminate stick-slip, thereby enabling smoother delivery of implants. Additionally or alternatively, some embodiments may provide a one-handed reversal drive mechanism that can further enhance control of the delivery procedure.

[0037] As shown in several exemplary embodiments, those skilled in the art will recognize that the systems, apparatus and methods described herein are capable of various modifications and alterations that fall within the scope of the appended claims. Furthermore, descriptions of various alternative forms using terms such as “or” do not require mutual exclusivity unless clearly required by context, and the indefinite article “a” or “an” does not limit the subject matter to a single example unless clearly required by context. Components can also be combined or excluded in various configurations for sale, manufacture, assembly or use. For example, in some configurations, the nozzle 105, implant compartment 110, and actuator 115 can each be separated from each other or combined in various ways for manufacture or sale.

[0038] The claims may also include additional subject matter not specifically described. For example, certain features, elements, or embodiments may be omitted from the claims if they are not necessary to distinguish novel and inventive features from those already known to those skilled in the art. Features, elements, and embodiments described in relation to some embodiments may also be omitted, combined, or replaced by identical, equivalent, or similar features without departing from the scope of the invention as defined by the appended claims.

Claims

1. A device for delivering implants to the eye, A gear rack configured to be coupled to the aforementioned implant, Forward gear wheel and, The input gear wheel meshed with the forward gear wheel, An operating lever configured to rotate the input gear wheel, An idler gear wheel meshed with the aforementioned input gear wheel, A reversing gear wheel meshed with the aforementioned idler gear wheel, A pivot arm that can be operated to selectively engage the forward gear wheel and the reverse gear wheel with the gear rack, A device including a device.

2. The apparatus according to claim 1, further comprising a ratchet wheel coupled to the operating lever and the input gear wheel, wherein the ratchet wheel is configured to allow the operating lever to rotate the input gear wheel in only one direction.

3. The apparatus according to claim 1, further comprising an input shaft that connects the operating lever to the input gear wheel.

4. The apparatus according to claim 3, wherein the pivot arm is rotatable about the input shaft.

5. The apparatus according to claim 3, wherein the pivot arm is attached to the input shaft.

6. The pivot arm is operable to rotate between a first position and a second position. In the first position, the forward gear wheel is engaged with the gear rack, In the second position, the reversing gear wheel is engaged with the gear rack. The apparatus according to claim 1.

7. The apparatus according to claim 6, further comprising a spring configured to return the pivot arm to the first position.

8. A device for delivering implants to the eye, A gear rack configured to be coupled to the aforementioned implant, A forward gear wheel meshed with the gear rack, The input gear wheel meshed with the forward gear wheel, A ratchet wheel coupled to the input gear wheel, An operating lever configured to rotate the ratchet wheel in only one direction, thereby rotating the input gear wheel and the forward gear wheel, and thereby advancing the gear rack, A device including a device.

9. An idler gear wheel meshed with the aforementioned input gear wheel, A reversing gear wheel meshed with the aforementioned idler gear wheel, A pivot arm that can be operated to selectively engage the forward gear wheel and the reverse gear wheel with the gear rack, This also includes, The apparatus according to claim 8.

10. The apparatus according to claim 9, further comprising an input shaft that connects the operating lever to the input gear wheel.

11. The apparatus according to claim 10, wherein the pivot arm is rotatable around the input shaft.

12. The apparatus according to claim 10, wherein the pivot arm is attached to the input shaft.

13. The pivot arm is operable to rotate between a first position and a second position. In the first position, the forward gear wheel is engaged with the gear rack, In the second position, the reversing gear wheel is engaged with the gear rack. The apparatus according to claim 9.

14. The apparatus according to claim 13, further comprising a spring configured to return the pivot arm to the first position.

15. A nozzle having a delivery lumen, The implant section connected to the nozzle, A push rod is configured to connect the gear rack to the implant within the implant compartment and to advance the implant into the delivery lumen, The apparatus according to claim 8, further comprising:

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