Pupil dilator assembly

Abstract

The pupillary dilator assembly includes a delivery device comprising a body having a proximal end, a distal end, and a longitudinal axis. The delivery port extends distally from the distal end. The dilator receiving portion is located at the distal end within the body and has a proximal slot and a distal slot, respectively, extending along the longitudinal axis. Both the proximal slot and the delivery slot are in fluid communication with the delivery port. A slider is slidably disposed within the body and configured to move longitudinally along the longitudinal axis. A hook extends distally from the slider and is configured to slide outward from the delivery port through the proximal and distal slots. The pupillary dilator is disposed within the dilator receiving portion and is configured to be pressed distally by the hook through the distal slot and the delivery port and delivered.

Description

Technical Field

[0001] The present invention relates to a pupil dilator and a delivery device for delivering the dilator to a patient's eye and retrieving the dilator after use.

Background Art

[0002] (Cross - reference to related applications) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 466,413, filed May 15, 2023, which is hereby incorporated by reference in its entirety.

[0003] Pupil dilators are known to engage the edge of the iris, push back the edge, and expand the visible area of the underlying pupil, thereby allowing an ophthalmologist to access more peripheral regions of the pupil for surgery.

[0004] It would be beneficial to provide a pupil dilator that can be delivered and retrieved by the same hook device with the ring folded upon itself during delivery to the eye. It would also be beneficial to provide a pre - loaded pupil dilator with an expansion ring having a controlled inside - out circular deployment.

Summary of the Invention

Problems to be Solved by the Invention

[0005] In conventional pupil dilators, it is required to efficiently perform delivery to the eye and retrieval after use. In particular, constructing a system that can safely introduce the dilator in a folded state upon itself during delivery and reliably retrieve it using the same device has been a problem. Also, it is desired to provide a pupil dilator and its delivery device that can stably achieve a controlled circular deployment from the inside to the outside in a pre - loaded state.

Means for Solving the Problems

[0006] According to one aspect of the present invention, a pupil dilator assembly including a delivery device and a pupil dilator is provided. The delivery device comprises a body having a proximal end, a distal end, and a central longitudinal axis extending between the proximal end and the distal end; a delivery port extending distally from the distal end; and a dilator receiving portion located at the distal end within the body.

[0007] The expansion body receiving portion has a proximal slot and a distal slot, both of which extend along the central longitudinal axis, and both of which are in fluid communication with the outlet.

[0008] The dispensing device further comprises a slider slidably disposed within the main body and configured to move longitudinally along the central longitudinal axis, and a hook extending distally from the slider and configured to slide outward from the dispensing port through the proximal slot and the distal slot.

[0009] The pupillary dilator is positioned within the dilator receiving portion and is pressed distally by the hook through the distal slot and the outlet, and is delivered to the eye.

[0010] According to another aspect of the present invention, a pupil dilator delivery device is provided. The delivery device comprises a body having a proximal end, a distal end, and a central longitudinal axis extending between the proximal end and the distal end; an outlet extending distally from the distal end; and a dilator receiving portion located at the distal end within the body. The dilator receiving portion has a proximal slot and a distal slot, both of which extend along the central longitudinal axis, and both the proximal slot and the delivery slot are in fluid communication with the outlet. The delivery device further comprises a slider slidably disposed within the body and configured to move longitudinally along the central longitudinal axis; and a hook extending distally from the slider and configured to slide outward from the outlet through the proximal slot and the distal slot. [Effects of the Invention]

[0011] According to the present invention, it is possible to provide a pupil dilator that can be delivered and retrieved by the same hook device, and in which the ring folds over itself during delivery to the eye. It is also possible to provide a pre-loaded pupil dilator equipped with a dilation ring having a controlled inverted circular deployment. [Brief explanation of the drawing]

[0012] [Figure 1] This is a perspective view of a pupil dilator assembly according to an exemplary embodiment of the present invention. [Figure 2] Figure 1 is a side view of the pupil dilator assembly. [Figure 3] Figure 1 is a plan view of the pupil dilator assembly. [Figure 3A] Figure 1 is an exploded view of the pupil dilator assembly. [Figure 4] This is a magnified view of area 4 in Figure 3, with the top cover removed. [Figure 5] Figure 1 is a side view of the pupil dilator assembly with the hook extended distally. [Figure 6] This is an enlarged view of region 6 in Figure 5. [Figure 7] Figure 5 is a perspective view of the pupil dilator assembly. [Figure 8] This is an enlarged view of region 8 in Figure 7. [Figure 9] Figure 1 is a perspective view of the dilation ring used with the pupil dilator assembly. [Figure 10] Figure 9 is a plan view of the expansion ring. [Figure 11] Figure 9 is a side view of the expansion ring. [Figure 12A] This is a schematic diagram of how the dilation ring in Figure 9 is engaged to eject the ring from the pupil dilator assembly in Figure 1. [Figure 12B] Figure 1 is a schematic diagram illustrating how the dilation ring is advanced into the outlet of the pupil dilator assembly. [Figure 12C] It is a schematic diagram of a method for advancing an expansion ring through the outlet of the pupil dilator assembly of FIG. 1. [Figure 13A] It is a schematic diagram showing the state where the expansion ring of FIG. 9 first engages with the iris of the eye. [Figure 13B] It is a schematic diagram showing the state where the ring of FIG. 13A further engages with the iris. [Figure 13C] It is a schematic diagram showing the state where the ring of FIG. 13B further engages with the iris. [Figure 13D] It is a schematic diagram showing the state where the ring of FIG. 13C is fully engaged with the iris and expanding the iris. [Figure 14A] It is a schematic diagram showing the state where the pupil dilator assembly of FIG. 5 engages with the expansion ring and removes the ring from the iris. [Figure 14B] It is a schematic diagram showing the state where the expansion ring of FIG. 14A is completely detached from the iris. [Figure 15] It is a perspective view of an alternative embodiment of the outlet extending distally from the distal end of the body of the pupil dilator assembly. [Figure 16] It is a plan view of an alternative embodiment of the expansion ring used in the pupil dilator assembly of FIG. 1. [Figure 17] It is a perspective view of the expansion ring of FIG. 16. [Figure 18] It is a side view of the expansion ring of FIG. 16 as seen along line 18-18 of FIG. 16. [Figure 19] It is a cross-sectional view of the prong engagement portion of the expansion ring of FIG. 16 as seen along line 19-19 of FIG. 16. [Figure 20] It is a perspective view of an alternative embodiment of the hook assembly used with the pupil dilator assembly of FIG. 1. [Figure 21A] It is a schematic diagram showing the start of a method for advancing the expansion ring of FIG. 16 using the hook of FIG. 20. [Figure 21B] It is a schematic diagram showing the state where the hook of FIG. 20 is engaged with the expansion ring of FIG. 16. [Figure 21C]Figure 20 is a schematic diagram showing the hook pressing the expansion ring in Figure 16 into the outlet. [Figure 21D] This schematic diagram shows the hook in Figure 20 and the expansion ring in Figure 16 fully advanced into the outlet. [Modes for carrying out the invention]

[0013] In the following detailed description, reference is made to the accompanying drawings which constitute part of this specification and illustrate specific embodiments in which the invention can be carried out. While these embodiments are described in sufficient detail to enable those skilled in the art to carry out the invention, it should be understood that other embodiments may be utilized and that logical, mechanical, electrical, and chemical modifications may be made without departing from the spirit and scope of the invention. Therefore, the following detailed description should not be taken as restrictive, and the scope of the invention is defined solely by the appended claims.

[0014] In the drawings, the same reference numerals refer to the same part across several drawings. Any embodiment or design described herein as “exemplary” should not necessarily be construed as being preferable or advantageous to any other embodiment or design.

[0015] Referring to the drawings, Figures 1 to 8 show a pupil dilator assembly 100 according to an exemplary embodiment of the present invention. The pupil dilator assembly 100 includes a delivery device 110 and a pupil dilator (hereinafter referred to as "ring 170") pre-loaded within the delivery device 110. The delivery device 110 includes an outer casing (hereinafter referred to as "body 112"), the body 112 having a proximal end 114, a distal end 116, and a central longitudinal axis 118 extending between the proximal end 114 and the distal end 116. The body 112 is configured to fit in the surgeon's hand.

[0016] The top cover 120 is positioned above the distal end 116 of the main body 112. The top cover 120 may be transparent or may include a magnifying lens 122 so that the surgeon can observe the condition of the ring 170 inside the device, as will be described in detail below. The outlet 124 extends distally from the distal end 116 of the main body 112.

[0017] As best shown in Figures 4 and 6, the expander receiving section 130 is located within the main body 112 and proximal to the outlet 124. The expander receiving section 130 is configured to accommodate the ring 170 therein. As shown in Figure 4, the expander receiving section 130 may be tapered from wide to narrow in the proximal to distal direction. Alternatively, or in addition, the side wall 132 defining the expander receiving section 130 may include a plurality of retainers 134 (Figure 6) extending into the expander receiving section 130. The retainers 134 are configured to hold the ring 170 in place within the expander receiving section 130 without causing it to accidentally slip out of the outlet 124.

[0018] The slider 140 is slidably positioned within the body 112 and configured to move (translate) longitudinally along the central longitudinal axis 118. The slider 140 includes a button portion 142 configured to be engaged by the surgeon's finger (e.g., thumb). By moving the button portion 142 longitudinally, the slider 140 moves within the body 112. This configuration allows the surgeon to keep their other hand free.

[0019] The hook 150 extends distally from the slider 140. The hook 150 is configured to slide outward from the outlet 124 through the proximal slot 152 and the distal slot 154 (see Figures 13 and 15). The ring 170 is positioned within the expander receiving portion 130 and is configured to be delivered to the eye by being pressed distally by the hook 150 through the distal slot 154 and the outlet 124.

[0020] The hook 150 includes a proximal leg 156 extending downward from the bottom surface of the slider 140, as best shown in Figures 15 and 16. A distal leg 158 extends distally from the bottom of the proximal leg 156. As shown in Figures 4 and 6, the proximal slot 152 extends from the proximal end of the expander receiver 130 to the distal slot 154. The distal slot 154 extends from the distal end of the expander receiver 130 to the outlet 124. The proximal slot 152 and the distal slot 154 are directly adjacent to each other and longitudinally aligned. The proximal slot 152 and the distal slot 154 are also positioned along the upper surface of the expander receiver 130.

[0021] Referring further to Figures 15 and 16, the hook 150 may further include an extension member 160 extending from the distal end of the distal leg portion 158. The extension member 160 has a pressing portion 162 extending distally therefrom, which is configured to push the ring 170 distally from the expander receiving portion 130 through the outlet 124. The extension member 160 may also include a tension portion 164 extending proximal therefrom, which is configured to pull the ring 170 proximal through the outlet 124 and retrieve it into the expander receiving portion 130.

[0022] Referring to Figures 9 to 11, the ring 170 includes a plurality of connected arc-shaped members 172. In the illustrated embodiment, there are six arc-shaped members 172a, 172b, 172c, 172d, 172e, and 172f.

[0023] Each arc-shaped member 172 includes an outer distal portion 174, an outer intermediate portion 176 attached to the outer distal portion 174, an outer proximal portion 178 attached to the outer intermediate portion 176, an inner proximal portion 180 attached to the outer proximal portion 178, an inner intermediate portion 182 attached to the inner proximal portion 180, and an inner distal portion 184 attached to the inner intermediate portion 182 and the outer distal portion 174.

[0024] As best shown in Figures 9 and 10, a separate living hinge 186 attaches each of the multiple arcuate members 172 to an adjacent one among the multiple arcuate members 172. For example, living hinge 186a connects arcuate member 172a to arcuate member 172b. Each of the outer distal portion 174 and the inner distal portion 184 has an operating hole 188 formed therein. The operating hole 188 allows the surgeon to manipulate the ring 170 on the iris 52, as will be described in more detail below.

[0025] As best shown in Figure 11, each of the arc-shaped members 172 further includes an upper lip portion 190 and a lower lip portion 192 projecting outward therefrom. In the illustrated embodiment, each of the upper lip portion 190 and the lower lip portion 192 includes an arc-shaped cross-sectional shape (arc-shaped profile) that tapers from larger to smaller in the distal to proximal direction. This arc-shaped cross-sectional shape provides structural integrity (rigidity) to the ring 170 and provides sufficient contact area with the surface of the iris 52, enabling a uniform peripheral structure when the ring contracts.

[0026] Figures 12A, 12B, and 12C illustrate how the ring 170 is dispensed from the dispensing device 110. In Figure 12A, the hook 150 engages with the ring 170 in the expander receiving portion 130. Specifically, the tension portion 164 engages with the proximal end of the ring 170, while the pressing portion 162 engages with the distal end of the ring 170.

[0027] As shown in Figure 12B, as the slider 140 moves distally, the hook 150 moves distally, pushing the ring 170 out of the expander receiving portion 130 into the outlet 124. As the ring 170 moves distally through the outlet 124, the lateral proximal portion 178 and the medial proximal portion 180 move toward the center of the ring 170, resulting in the lateral distal portion 174, the lateral intermediate portion 176, the medial proximal portion 180, and the medial intermediate portion 182 all contracting (compressing) inward toward the central longitudinal axis 118.

[0028] As shown in Figure 12C, as the slider 140 advances further distally, the ring 170 is ejected completely through the outlet 124. Once the ring 170 exits the outlet 124, it begins to expand into a relaxed, uncontracted state, as shown in Figure 13A. Specifically, the lateral distal portion 174 and the medial distal portion 184 begin to engage with the underside of the edge of the iris 52.

[0029] As further shown in Figures 13B, 13C, and 13D, the ring 170 expands further and the slider 140 moves further forward until the ring 170 is completely pushed out of the outlet 124, at which point the upper lip 190 and lower lip 192 of each arc-shaped member 172 engage with the edge of the iris 52. As shown in Figure 13D, once the ring 170 is fully ejected, it expands in a circular shape, dilating the iris 52 and widening the pupil.

[0030] Figures 14A and 14B illustrate the method for retrieving the ring 170 from the eye 50. To retrieve the ring 170, the surgeon extends the hook 150 distally and engages the tensioning portion 164 with the proximal end of the ring 170. Next, as shown in Figure 14A, the hook 150 is retracted proximal by pulling the slider 140 proximal, and the ring 170 begins to detach from the iris 52.

[0031] As shown in Figure 14B, when the hook 150 retracts further proximal, the ring 170 is retracted proximal through the outlet 124. As the ring 170 is retracted proximal into the outlet 124, it contracts inward in a manner similar to that of the ejection described above in relation to Figure 12B, and eventually returns completely into the expander receiving section 130 as shown in Figure 12A.

[0032] Figure 15 shows an alternative embodiment of the outlet 224. The outlet 224 extends distally from the distal end 116 of the main body 112 and includes a dogleg-shaped bend. This dogleg-shaped configuration allows the assembly to approach the eye 50 at a flatter angle to the iris 52, providing better access for the expansion ring 170 to engage with the iris 52.

[0033] Figures 16 to 19 show a ring 370, which is an alternative embodiment of the ring used with the pupil dilator assembly 100. The ring 370 includes a plurality of connected arcuate members 372. In the illustrated embodiment, there are six arcuate members 372a, 372b, 372c, 372d, 372e, and 372f. Each arcuate member 372 includes an outer distal portion 374, an outer intermediate portion 376 attached to the outer distal portion 374, an outer proximal portion 378 attached to the outer intermediate portion 376, an inner proximal portion 380 attached to the outer proximal portion 378, an inner intermediate portion 382 attached to the inner proximal portion 380, and an inner distal portion 384 attached to the inner intermediate portion 382 and the outer distal portion 374.

[0034] Similar to the ring 170, a separate living hinge 386 connects each of the arcuate members 372 to an adjacent one. The ring 370 may further include prongs 388 extending outward from the outer surfaces of some of the arcuate members 372, for example, arcuate members 372a and 372d. The prongs 388 are configured to engage by hooks, as will be described in more detail below. Each of the arcuate members 372 further includes an upper lip portion 390 and a lower lip portion 392 projecting outward therefrom, which are configured to engage with the iris 52.

[0035] Figure 20 shows a hook 450, which is an alternative embodiment of the hook used with the slider 140. The hook 450 is substantially similar to the hook 150 shown in Figure 15, but instead of the extension member 160, it has a pair of prong engagements 462 that extend laterally from there. The prong engagements 462 are configured to engage with the prongs 388 of the ring 370.

[0036] Figures 21A to 21D illustrate how the ring 370 is dispensed. As shown in Figure 21A, the hook 450 is positioned proximal to the ring 370. As shown in Figure 21B, the hook 450 advances distally, and the prong engagement portion 462 engages with the prongs 388 of the ring 370. As shown in Figures 21C and 21D, the hook 450 advances further distally, pushing the ring 370 into the outlet 124 (not shown), and the ring 370 contracts inward in the same manner as the ring 170 described above.

[0037] The embodiments described herein are illustrative only, and those skilled in the art will understand that many variations and modifications can be made without departing from the spirit and scope of the invention. All such variations and modifications are intended to fall within the scope of the invention as described herein. Furthermore, all disclosed embodiments are not necessarily alternative and may be combined to form multiple embodiments of the invention.

[0038] 100 Pupil Dilater Assemblies 110 Sending device 112 Main body (outer casing) 114 Proximal end 116 Distal end 118 Central longitudinal axis 120 Top Cover 122 Magnifying Lens 124 Outlet 130 Expander receptor 132 Side wall 134 Reversal stop 140 Slider 142 Button section 150 hooks 152 Proximal Slots 154 distal slots 156 Proximal leg 158 Distal leg 160 Extension member 162 Pressing part 164 Tensile section 170 Ring (Pupil Dilater) 172, 172a~172f Arc-shaped members 174 Lateral distal part 176 Outer middle part 178 Lateral proximal part 180 Medial proximal part 182 Inner middle part 184 Medial distal portion 186, 186a Living Hinge 188 Operation hole 190 Upper lip 192 Lower lip area 224 Outlet (alternative embodiment) 370 Ring (Alternative Embodiment) 372, 372a~372f Arc-shaped members 374 Lateral distal part 376 Outer middle part 378 Lateral proximal part 380 Medial proximal part 382 Inner middle part 384 Medial distal portion 386 Living Hinge 388 Prongs (forked part) 390 Upper lip 392 Lower lip area 450 Hook (Alternative Embodiment) 462 Prong engagement section 50 eyes 52 Iris

Claims

1. A pupil dilator assembly including a delivery device and a pupil dilator, The aforementioned transmission device is, A body having a proximal end, a distal end, and a central longitudinal axis extending between the proximal end and the distal end, An outlet extending distally from the distal end, An expandable body receiving portion located at the distal end within the main body, having a proximal slot and a distal slot, both of which extend along the central longitudinal axis, and both of which are in fluid communication with the outlet, A slider is slidably disposed within the main body and configured to move longitudinally along the central longitudinal axis, A hook extending distally from the slider and configured to slide outward from the outlet through the proximal slot and the distal slot, is provided, A pupillary dilator assembly comprising a pupillary dilator positioned within the dilator receiving portion and pressed distally by the hook through the distal slot and the outlet, thereby being delivered to the eye.

2. The pupil dilator assembly according to claim 1, further comprising a magnifying lens positioned above the dilator receiving portion.

3. The pupil dilator assembly according to claim 1, wherein the dilator receiving portion is tapered from wide to narrow in the direction from proximal to distal.

4. The pupil dilator assembly according to claim 1, wherein the wall defining the dilator receiving portion comprises a plurality of stoppers extending into the dilator receiving portion.

5. The pupil dilator assembly according to claim 1, wherein the pupil dilator includes a ring having a plurality of connected arc-shaped members.

6. The plurality of arc-shaped members, The lateral distal portion, The outer intermediate portion attached to the outer distal portion, The outer proximal portion attached to the outer intermediate portion, The inner proximal portion attached to the outer proximal portion, The inner intermediate portion attached to the inner proximal portion, The pupil dilator assembly according to claim 5, comprising the inner distal portion attached to the inner intermediate portion and the outer distal portion.

7. The pupil dilator assembly according to claim 6, further comprising a separate living hinge for attaching each of the plurality of arc-shaped members to an adjacent one among the plurality of arc-shaped members.

8. The pupil dilator assembly according to claim 6, wherein an operating hole is formed in each of the outer distal portion and the inner distal portion.

9. The pupil dilator assembly according to claim 6, wherein each of the arc-shaped members further includes an upper lip portion and a lower lip portion projecting outward therefrom.

10. The pupil dilator assembly according to claim 9, wherein each of the upper lip portion and the lower lip portion includes an arc-shaped cross-section that tapers from larger to smaller in the distal to proximal direction.

11. The pupil dilator assembly according to claim 6, wherein as the ring advances distally through the outlet, the outer proximal portion and the inner proximal portion advance toward the center of the ring such that the outer distal portion, the outer intermediate portion, the inner proximal portion, and the inner intermediate portion all contract inward toward the central longitudinal axis.

12. The pupil dilator assembly according to claim 1, comprising an extension member extending from the hook, the extension member having a pressing portion extending distally therefrom, the pressing portion being configured to press the ring distally from the dilator receiving portion through the outlet.

13. The pupil dilator assembly according to claim 12, wherein the extension member further comprises a tensioning portion extending proximal therefrom, and the tensioning portion is configured to pull the ring proximal through the outlet into the dilator receiving portion.

14. A pupil dilator delivery device, A body having a proximal end, a distal end, and a central longitudinal axis extending between the proximal end and the distal end, An outlet extending distally from the distal end, An expandable body receiving portion located at the distal end within the main body, having a proximal slot and a distal slot, both of which extend along the central longitudinal axis, and both of which are in fluid communication with the outlet, A slider is slidably disposed within the main body and configured to move longitudinally along the central longitudinal axis, A pupil dilator delivery device comprising: a hook extending distally from the slider and configured to slide outward from the outlet through the proximal slot and the distal slot;

15. The pupil dilator delivery device according to claim 14, further comprising a magnifying lens positioned above the dilator receiving portion.

16. The pupil dilator delivery device according to claim 14, wherein the dilator receiving portion is tapered from wide to narrow in the direction from proximal to distal.

17. The pupil dilator delivery device according to claim 14, wherein the wall defining the dilator receiving portion comprises a plurality of return stoppers extending into the dilator receiving portion.

18. The pupil dilator delivery device according to claim 14, comprising an extension member extending from the hook, the extension member having a pressing portion extending distally therefrom, the pressing portion being configured to press the ring distally from the dilator receiving portion through the delivery port.

19. The pupil dilator delivery device according to claim 18, wherein the extension member further comprises a tensioning portion extending proximal therefrom, and the tensioning portion is configured to pull the ring proximal through the delivery port into the dilator receiving portion.

20. The pupil dilator delivery device according to claim 14, wherein the hook is configured to retract distally to the dilator receiving portion.

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