Management of haptic parts of surgical implants
Patent Information
- Application Number
- JP2024546284
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-03-01
- Filing Date
- 2023-02-28
- Publication Date
- 2025-03-13
AI Technical Summary
【0011】 いくつかの実施形態に関連して記述される特徴、要素及び態様は、省略するか、組み合わせるか又は代替的な特徴によって置換することもできる。特許請求される主題の他の特徴、目的、利点並びにそれを製造及び使用する好適な態様について、例示的な実施形態の添付図面を参照して以下でより詳細に記述する。
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Figure 2025506642000001_ABST
Abstract
Description
[Technical field]
[0001] The present invention, as set forth in the accompanying claims, relates generally to ophthalmic surgery and includes, but is not limited to, systems, devices and methods for inserting an implant into an eye. [Background technology]
[0002] The human eye can suffer from many diseases that can cause anything from mild vision loss to complete vision loss. Contact lenses and glasses can compensate for some diseases, while others may require eye surgery. In some instances, an implant may be advantageous or desirable. For example, an intraocular lens can replace the cloudy natural lens in the eye to improve vision.
[0003] While the benefits of intraocular lenses and other implants are known, improvements in delivery systems, components and processes continue to be made to improve outcomes and benefit patients. Summary of the Invention [Means for solving the problem]
[0004]
[0006] Novel and useful systems, apparatus 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.
[0005] For example, some embodiments can be used to fold and compress an intraocular lens or other optical implant prior to its insertion into various locations within the eye using various surgical techniques. Such embodiments can include or consist essentially of a haptic folding mechanism configured to fold one or more haptics onto the top of the optic before the optic is folded into the nozzle. In some embodiments, a lifting mechanism can be configured to lift and restrain the anterior haptics during delivery of the implant. This mechanism can restrain the anterior haptics higher than the optic so that the anterior haptics can passively drop onto the top of the optic.
[0006] In a more specific example, the haptic lifter can lift the front haptic so that in an initial configuration, the front haptic is higher than the optic. During delivery, the lens can be pushed forward so that the optic is advanced under the front haptic. The haptic lifter can initially constrain the front haptic, which can then fold and release on top of the optic as the optic continues to advance.
[0007] More generally, some embodiments of an apparatus for ophthalmic surgery may include an implant bay including a haptic lifter and an implant disposed within the implant bay. The implant may include an optic and an anterior haptic, and the haptic lifter may be configured to lift the anterior haptic relative to the optic. In more specific embodiments, the optic may be configured to be advanced under the anterior haptic, and the haptic lifter may be configured to hold the anterior haptic until the optic is under the anterior haptic. In some embodiments, the optic has a leading edge and a trailing edge, and the implant bay may be configured to lift the leading edge relative to the trailing edge.
[0008] More specific embodiments may additionally include a plunger configured to advance the optic under the front haptic while the haptic lifter holds the distal end of the front haptic over the optic, hi some embodiments, the plunger may be configured to advance the optic until the distal end of the front haptic is released from the haptic lifter and drops onto the optic.
[0009] In another aspect, an apparatus for ophthalmic surgery may include a nozzle, an implant bay coupled to the nozzle, the implant bay including a base, a cap and a haptic lifter coupled to the base to form a cavity in the implant bay, an implant disposed in the cavity, the implant including an optic, an anterior haptics and a posterior haptics, and an actuator coupled to the base. The haptic lifter may lift the anterior haptics relative to the optic, and the actuator may be configured to fold the posterior haptics onto the optic and advance the optic under the anterior haptics towards the nozzle until the anterior haptics are released from the haptic lifter onto the optic. The actuator may be configured to advance the implant from the implant bay into the nozzle with the anterior haptics and the posterior haptics on the optic.
[0010] In yet another exemplary embodiment, an apparatus for ophthalmic surgery may include a nozzle having a delivery lumen, an implant bay, an implant, and an actuator. The implant bay may include a base coupled to the nozzle and a cap coupled to the base to form a cavity in the implant bay that is fluidly coupled to the delivery lumen. The base may include a haptic lifter and an optical ramp. The implant may be disposed in the cavity. In some embodiments, the implant may include an optic body having a leading edge and a trailing edge, and the optic body may be disposed on the optical ramp such that the leading edge is lifted relative to the trailing edge. The implant may further include anterior haptics and posterior haptics coupled to the optic body. The anterior haptics may have a distal end restrained by the haptic lifter such that the distal end is lifted relative to the leading edge. The actuator may be coupled to the base and may include a housing and a plunger at least partially disposed within the housing. The plunger can be configured to fold the rear haptics onto the optic body, advance the optic body under the front haptics towards the delivery lumen until the front haptics are released from the haptics lifter onto the optic body, and advance the implant from the implant bay through the delivery lumen with the front and rear haptics on the optic body.
[0011] Features, elements and aspects described in connection with some embodiments may be omitted, combined or replaced by 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.
[0012] The accompanying drawings illustrate certain objects, advantages and preferred modes of making and using several embodiments of the claimed subject matter, in which like reference numbers represent like parts throughout the examples. [Brief description of the drawings]
[0013] [Figure 1] FIG. 1 is an isometric view of an example of a device for delivering an implant to an eye. [Diagram 2] FIG. 2 is an exploded view of the device of FIG. 1. [Diagram 3] FIG. 3 is a top view of a base and implant associated with the device of FIG. 2. [Figure 4] FIG. 4 is a front view of the base and implant of FIG. 3. [Figure 5A] FIG. 2 is a partial cross-sectional view showing the device of FIG. 1 in a first state. [Figure 5B] 2 is a partial cross-sectional view showing the device of FIG. 1 in a second state; [Figure 5C] FIG. 2 is a partial cross-sectional view showing the device of FIG. 1 in a third state. [Figure 5D] FIG. 2 is a partial cross-sectional view showing the device of FIG. 1 in a fourth state. [Figure 6A-6B] FIG. 2 is a schematic diagram illustrating an example of the use of the device of FIG. 1 to deliver an implant to the eye. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0014] The following description of exemplary embodiments provides information to enable one of ordinary skill in the art to make and use the subject matter recited in the appended claims, but may omit certain details already known in the art. Thus, it should be understood that the following detailed description is illustrative only and not limiting.
[0015] Exemplary embodiments may be described below with reference to the spatial relationships of various elements or the spatial orientations of various elements depicted in the accompanying drawings. Typically, such relationships or orientations assume a frame of reference that is consistent with or relative to a patient in a position to receive an implant. However, as will be appreciated by those skilled in the art, this frame of reference is merely a convenience for explanation, rather than a strict specification.
[0016] 1 is an isometric view of one example of an apparatus 100 capable of delivering an implant into an eye. In some embodiments, the apparatus 100 may include two or more modules that may be configured to be coupled and separated as appropriate for storage, assembly, use, and disposal. As shown in FIG. 1, some embodiments of the apparatus 100 may include a nozzle 105, an implant bay 110 coupled to the nozzle 105, and an actuator 115 coupled to the implant bay 110.
[0017] The nozzle 105 generally includes a tip 120 adapted for insertion through an incision into the eye. The size of the tip 120 may be adapted to surgical requirements and techniques as needed. Small incisions are generally preferred, for example to reduce or minimize healing times. In some instances, incisions of less than 2 millimeters may be preferred, and in some embodiments, the tip 120 of the nozzle 105 may have a width of less than 2 millimeters.
[0018] The implant bay 110 generally represents various types of devices suitable for storing an implant prior to delivery into the eye. In some embodiments, the implant bay 110 may additionally or alternatively be configured to prepare the implant for delivery. For example, some embodiments of the implant bay 110 may be configured to be actuated by a surgeon or other operator to prepare the implant for delivery by subsequent actuation of the actuator 115. In some embodiments, the implant bay 110 may be configured to actively deform, stretch, expand, or otherwise manipulate features of the implant before the implant is advanced into the nozzle 105. For example, the implant bay 110 may be configured to fold, tuck, stretch, or unfold one or more features, such as haptics, of an intraocular lens.
[0019] The actuator 115 is generally configured to advance the implant from the implant bay 110 into the nozzle 105, and then from the nozzle 105 through the incision and into the eye. The actuator 115 of Figure 1 generally includes a housing 125 and a plunger assembly 130. The housing 125 and the plunger assembly 130 are generally formed of a substantially rigid material, such as a medical grade polymeric material.
[0020] In general, the components of the apparatus 100 may be directly or indirectly coupled. For example, the nozzle 105 may be directly coupled to the implant bay 110 and indirectly coupled to the actuator 115 through the implant bay 110. The coupling may include fluid, mechanical, thermal, electrical or chemical coupling (such as chemical coupling), or in some circumstances a combination of couplings. For example, the implant bay 110 may be mechanically coupled to the actuator 115 and mechanically and fluidly coupled to the nozzle 105. In some embodiments, the components may be coupled by physical proximity, integrated into a single structure or formed from the same piece of material.
[0021] Figure 2 is an exploded view of the device 100 of Figure 1 and shows additional details that may be associated with some embodiments. For example, the implant bay 110 of Figure 2 (see Figure 1) includes a base 205 and a cap 210 that may be coupled to the base 205 as shown in Figure 1. The base 205 may extend from or be coupled to the housing 125 in some examples.
[0022] The implant 215 may be disposed between the base 205 and the cap 210. In the example of FIG. 2, the implant 215 is an intraocular lens having an optic 220. In some examples, the optic 220 may have a shape similar to the natural lens of the eye. Examples of suitable materials may include silicone, acrylic, and combinations of such suitable materials. The implant 215 may also include one or more features that position the optic 220 within the eye, such as anterior haptics 225 and posterior haptics 230. In the example of FIG. 2, the anterior haptics 225 and posterior haptics 230 extend from opposite sides of the optic 220. In some examples, the implant 215 may be fluid-filled, such as a fluid-filled accommodating intraocular lens.
[0023] As shown in the example of FIG. 2, some embodiments of the plunger assembly 130 may include a push rod 235, a plunger 240 coupled to one end of the push rod 235, and a finger flange 245 coupled to an opposite end of the push rod 235.
[0024] The nozzle 105 of FIG. 2 includes a bay interface 250 that may be coupled to the base 205 .
[0025] Figure 3 is a top view of the base 205 and implant 215 of Figure 2 showing additional details that may be associated with some embodiments. The base 205 of Figure 3 includes a haptic lifter 305 configured to receive a portion of the front haptic 225. As shown in the example of Figure 3, some embodiments of the haptic lifter 305 may include a pocket, notch, groove, recess, catch, or similar feature that may be integrated with the base 205. The haptic lifter 305 may be configured to receive a distal end 310 of the front haptic 225.
[0026] Figure 4 is a front view of the base 205 and implant 215 of Figure 3 showing additional details that may be associated with some embodiments. As shown in the example of Figure 4, the optic 220 can be recessed within the base 205 and the haptic lifter 305 can lift a portion of the anterior haptic 225 relative to the optic 220. In a more specific example, the haptic lifter 305 can lift a portion of the anterior haptic 225 relative to the leading edge 405 of the optic 220.
[0027] 5A-5D are cross-sectional views of the device 100 of FIG. 1 and show additional details that may be associated with some embodiments in various operating states. For example, FIG. 5A shows the device 100 in a first state in which an implant 215 is disposed in the implant bay 110. More specifically, as shown in FIG. 5A, the cap 210 may be coupled to the base 205 such that a cavity is formed in the implant bay 110 between the cap 210 and the base 205, and the implant 215 may be disposed in the cavity. In some embodiments, the optic 220 may be tilted within the base 205. For example, the optical tilt 505 may support at least a portion of the optic 220 such that the leading edge 405 (see FIG. 4) is elevated relative to the trailing edge 510, while the distal end 310 of the anterior haptic 225 remains elevated relative to the optic 220 (more specifically, the leading edge 405).
[0028] 5B illustrates additional details that may be associated with the example of FIG. 5A in a second state. With the distal ends 310 of the anterior haptics 225 held by the haptic lifter 305 and the anterior haptics 225 elevated relative to the optic 220, the plunger 240 can be advanced toward the implant 215 to fold the posterior haptics 230 over the optic 220, as shown in FIG. 5B.
[0029] 5C illustrates additional details that may be associated with the example of FIG. 5A in a third state. In some embodiments, the optic 220 can be advanced under the front haptics 225. For example, the plunger 240 can be configured to advance the optic 220 under the front haptics 225 while the haptics lifter 305 holds the distal end 310 in a lifted state. In a more specific example, as shown in FIG. 5B, the tip 515 of the plunger 240 can be advanced through the implant bay 110 with the front haptics 225 lifted and the rear haptics 230 folded. As the plunger 240 advances, the tip 515 can advance the optic 220 under the front haptics 225 toward the nozzle 105.
[0030] 5D illustrates additional details that may be associated with the embodiment of FIG. 5A in a fourth state. In the example of FIG. 5D, the optic 220 may be advanced by the plunger 240 until the front haptics 225 are released from the haptics lifter 305 and drop to the top of the optic 220. For example, in some embodiments, the advancement of the optic 220 may create tension in the front haptics 225 until the distal ends 310 of the front haptics 225 are pulled from the haptics lifter 305 and onto the optic 220. The plunger 240 may be advanced further to move the implant 215 in its collapsed state through the delivery lumen 520 of the nozzle 105 until the implant 215 is expelled from the tip 120.
[0031] 6A and 6B are schematic diagrams illustrating an example of the use of the device 100 of FIG. 1 to deliver an implant 215 to an eye 600. As shown, an incision 605 may be made in the eye 600, for example, 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 made in the cornea 615 of the eye 600. The incision 605 may be sized to allow for insertion of a portion of the nozzle 105 to deliver the implant 215 into the capsular bag 620. For example, in some examples, the size of the incision 605 may have a length of less than about 3000 microns (3 millimeters). In other examples, the incision 605 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.
[0032] After the incision 605 is made, the nozzle 105 is inserted through the incision 605 such that the width of the tip 120 matches the length of the incision 605, thereby allowing the nozzle 105 to extend into the interior 625 of the eye 600. The apparatus 100 can then eject the implant 215 through the nozzle 105 and into the capsular bag 620 of the eye 600, generally as described with reference to Figures 5A-5D.
[0033] In some embodiments, the implant 215 may include an intraocular lens having a shape similar to the eye's natural crystalline lens and may be manufactured from a number of materials. Examples of suitable materials may include silicone, acrylic, and combinations of such suitable materials. In some examples, the implant 215 may include a fluid-filled intraocular lens, such as a fluid-filled accommodating intraocular lens.
[0034] The implant 215 may be delivered in a folded state, and the anterior haptics 225 and posterior haptics 230 may return to a resting state at least partially curved around the optic 220 within the capsular bag 620, as shown in FIG. 5B. The capsular bag 620 may hold the implant 215 within the capsular bag 620 in a relative relationship to the eye 600 such that the optic 220 refracts light directed toward the retina (not shown). The anterior haptics 225 and posterior haptics 230 may engage the capsular bag 620 to secure the implant 215 therein. After the implant 215 is delivered within the capsular bag 620, the nozzle 105 may be removed from the eye 600 through the incision 605, allowing the eye 600 to recover over time.
[0035] The systems, devices, and methods described herein can provide significant advantages. For example, some embodiments can be particularly advantageous for delivery of intraocular implants. More specific advantages of some embodiments can include highly consistent folding of the anterior haptics without significantly increasing complexity or cost. Consistent and reliable folding of the haptics can greatly increase the consistency and reliability of implant delivery through small incisions across the diopter range, especially with preloaded implant delivery systems.
[0036] While shown in a few 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 are within the scope of the appended claims. Moreover, the description of various alternatives using terms such as "or" does not require mutual exclusivity unless clearly required by the context, and the indefinite article "a" or "an" does not limit the subject matter to a single example unless clearly required by the context. 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, the implant bay 110, and the actuator 115 may each be separate from one another or combined in various ways for manufacture or sale.
[0037] The claims may also encompass additional subject matter not specifically described in detail. For example, certain features, elements, or aspects may be excluded from the claims if they are not necessary to distinguish the novel 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: an implant bay including a haptic lifter; an implant disposed within the implant bay, the implant including an optic and an anterior haptic; wherein the haptic lifter lifts the front haptic relative to the optic.
2. the optic is configured to be advanced under the front haptic; and The device of claim 1 , wherein the haptic lifter is configured to hold the front haptic until the optic is below the front haptic.
3. The apparatus of claim 1 , wherein the haptic lifter includes a pocket within the implant bay.
4. The apparatus of claim 1 , wherein the haptic lifter includes a pocket in the implant bay that is elevated relative to the optic.
5. the optic has a leading edge and a trailing edge; and The apparatus of claim 1 , wherein the implant bay elevates the leading edge relative to the trailing edge.
6. The device of claim 1 , further comprising a plunger configured to advance the optic under the front haptic while the haptic lifter holds the front haptic.
7. The device of claim 6 , wherein the plunger is configured to advance the optic body until the leading haptic is released from the haptic lifter and drops onto the optic body.
8. The implant further includes a posterior haptic; and The device of claim 6 , wherein the plunger is further configured to fold the rear haptics over the optic body.
9. The device of claim 8 , wherein the plunger is configured to fold the rear haptics over the optic before advancing the optic under the front haptics.
10. 1. An apparatus for ophthalmic surgery, comprising: A nozzle; an implant bay coupled to the nozzle, the implant bay including a base, a cap and a haptic lifter coupled to the base to form a cavity within the implant bay; an implant disposed within the cavity, the implant including an optic, an anterior haptic, and a posterior haptic; an actuator coupled to the base; wherein the haptic lifter is configured to lift the front haptic relative to the optic body, and the actuator is configured to fold the rear haptic onto the optic body and advance the optic body under the front haptic toward the nozzle until the front haptic is released from the haptic lifter onto the optic body.
11. The apparatus of claim 10 , wherein the actuator is further configured to advance the implant from the implant bay into the nozzle with the leading haptics and the trailing haptics over the optic.
12. The apparatus of claim 10 , wherein the haptic lifter includes a pocket within the implant bay.
13. The apparatus of claim 10 , wherein the haptic lifter includes a pocket in the implant bay that is elevated relative to the optic.
14. the optic has a leading edge and a trailing edge; and The apparatus of claim 10 , wherein the implant bay elevates the leading edge relative to the trailing edge.
15. 1. An apparatus for ophthalmic surgery, comprising: a nozzle having a delivery lumen; An implant bay comprising: a base coupled to the nozzle, the base including a haptic lifter and an optical ramp; and a cap coupled to the base to form a cavity within the implant bay that is fluidly coupled to the delivery lumen an implant bay including: An implant disposed within the cavity, an optical body having a leading edge and a trailing edge, the optical body being disposed on the optical ramp such that the leading edge is elevated relative to the trailing edge; a front haptic having a distal end restrained by the haptic lifter such that the front haptic is lifted relative to the leading edge; and Rear haptics An implant comprising: an actuator coupled to the base, Housing, and A plunger disposed at least partially within the housing. An actuator including: wherein the plunger is configured to fold the rear haptics onto the optic body and advance the optic body under the front haptics towards the delivery lumen until the front haptics are released from the haptics lifter onto the optic body, and advance the implant from the implant bay through the delivery lumen with the front haptics and the rear haptics on the optic body.