WO2015046619A1

WO2015046619A1 - Method and apparatus for securement of ophthalmic devices

Info

Publication number: WO2015046619A1
Application number: PCT/JP2014/076336
Authority: WO
Inventors: Anand Doraiswamy; Jensen Buck; Manthan Patel
Original assignee: Santen Pharmaceutical Co., Ltd.
Priority date: 2013-09-25
Filing date: 2014-09-25
Publication date: 2015-04-02
Also published as: TW201527188A

Abstract

An insert for securing an ophthalmic device is provided that includes a base having a base top surface, a base perimeter wall, and a vertical center axis extending therethrough; one or more support arms extending vertically from the base top surface, wherein the one or more support arms include one or more respective interior walls; and one or more branches extending from the one or more interior walls; wherein the one or more branches and one or more support arms combine to form a support compartment for receiving and securing at least a portion of an ophthalmic device.

Description

DESCRIPTION

METHOD AND APPARATUS FOR SECUREMENT OF OPHTHALMIC DEVICES

Technical Field

[0001] The method and apparatus relate to securement of ophthalmic devices. Background Art

[0002] The need for ophthalmic devices, such as intraocular lenses, has dramatically increased as a significant portion of the population has reached an age where cataracts and other eye diseases are prevalent. In addition, the advancement of technology related to repairs to the eyes has created an increased demand for ophthalmic devices, such as intraocular lenses. The storage, shipment, and dispensing of ophthalmic devices from their associated packaging can provide numerous opportunities for damage and contamination. As such, an improved method, system, or apparatus for securing an ophthalmic device is desired.

Summary of Invention

[0003] In one embodiment, an insert for securing an ophthalmic device is provided that includes a base having a base top surface, a base perimeter wall, and a vertical center axis extending therethrough; one or more support arms extending vertically from the base top surface, wherein the one or more support arms include one or more respective interior walls; and one or more branches extending from the one or more interior walls; wherein the one or more branches and one or more support arms combine to form a support compartment for receiving and securing at least a portion of an ophthalmic device.

[0004] In another embodiment, A container for receiving and storing an ophthalmic device is provided that includes a circumferential outer wall interconnecting a container bottom and a container top, wherein the circumferential outer wall includes a top wall portion interconnected to a bottom wall portion at a circumferential raised edge; one or more substantially vertical ridges extending along the outer wall between the container bottom and the container top wherein the one or more ridges are situated substantially perpendicular to the raised edge; and a central container cavity bordered at least in part by a plurality of cavity walls situated interior of the outer wall, wherein the plurality of cavity walls extend at least indirectly between the container top and a container cavity bottom, and wherein the plurality of cavity walls are configured to receive a complimentarily-shaped lens insert. The apparatus, optionally (but normally) includes a container top or removable lid.

[0005] In another embodiment, an apparatus for securing and storing an ophthalmic device is provided that includes an insert and a container. The insert further including a base having a base top surface, a base perimeter wall, and vertical center axis extending therethrough; one or more support arms extending vertically from the base top surface, wherein the one or more support arms include respective interior walls; and one or more branches extending from the one or more interior walls, wherein the first one or more branches and one or more support arms combine to form a support compartment for receiving and securing at least a portion of an ophthalmic device. The container further includes a circumferential outer wall interconnecting a container bottom and a container top, wherein the circumferential outer wall includes a top wall portion integrated with a bottom wall portion at a circumferential raised edge; one or more ridges extending along the outer wall and downwards between the container bottom and the container top; and a central container cavity bordered at least in part by a plurality of cavity walls situated interior of the outer wall, wherein the plurality of cavity walls extend at least indirectly between the container top and a container cavity bottom, and wherein the plurality of cavity walls are configured to receive the insert.

[0006] In another embodiment, a method for securing an ophthalmic device is provided that includes the following steps: providing an insert having a support compartment for receiving at least a portion of an ophthalmic device, providing a container having a circumferential outer wall interconnecting a container bottom and a container top; a top wall portion integrated with a bottom wall portion at a circumferential raised edge, wherein the top wall portion and bottom wall portion combine to form the outer wall; one or more vertical ridges extending along the outer wall between the container bottom and the container top, wherein the ridges are situated substantially perpendicular to the raised edge; and a central container cavity situated interior of the outer wall and configured to receive the insert. The method further including: securing the container between the container top and the raised edge to prevent or substantially prevent vertical movement of the container; securing the container along at least one of the one or more vertical ridges to at least one of prevent or substantially prevent rotational movement of the container; inserting the insert into the central container cavity of the container; filling the container cavity with a solution; and securing a lid to the container top to secure the insert and solution inside the container. Brief Description of Drawings

[0007] Embodiments of the method and apparatus are disclosed with reference to the accompanying drawings and are for illustrative purposes only. The method and apparatus are not limited in their application to the details of construction or the arrangement of the components illustrated in the drawings. The method and apparatus are capable of other embodiments or of being practiced or carried out in other various ways. In the drawings, like numerals are used to refer to like structures shown in its various drawings:

[0008] FIG. 1 illustrates a perspective view of an exemplary apparatus for securement of an ophthalmic device;

[0009] FIG. 2 illustrates a perspective view of an exemplary insert;

[0010] FIG. 3 illustrates a top view of the insert of FIG. 2;

[0011] FIG. 4 illustrates a bottom view of the insert of FIG. 2;

[0012] FIG. 5 illustrates a front section view taken along line A-A of FIG. 3;

[0013] FIG. 6 illustrates a front perspective view of an exemplary container;

[0014] FIG. 7 illustrates a side view of the container of FIG. 6;

[0015] FIG. 8 illustrates a top view of the container of FIG. 6;

[0016] FIG. 9 illustrates a bottom view of the container of FIG. 6; and

[0017] FIG. 10 illustrates a front section view taken along line B-B of FIG. 8.

Description of Embodiments

[0018] Referring to FIG. 1, a perspective view of an exemplary apparatus or system 100 for securement of an ophthalmic device is illustrated. In at least some embodiments, as shown in FIG. 1, apparatus 100 includes a container 102, an insert 104, and a removable lid 106. An optional ophthalmic device, such as an intraocular lens 108 is also provided. Although intraocular lens 108 is discussed herein, the ophthalmic device can include any device suited for, or adaptable to ophthalmic insertion, such as intracorneal rings, shunts, etc. Lens 108 can be included in apparatus 100 or provided separately. In at least some embodiments, lens 108 includes an outer perimeter edge 107 and one or more anchors 109 for securing lens 108 in a fixed position relative to an eyeball (not shown) to maintain proper alignment. Insert 104 is configured to receive and to secure lens 108. Container 102 is configured to receive and at least partially secure insert 104. Lid 106 is releasably securable to container 102 to provide an enclosing seal after container 102 has received a sufficient supply of liquid therein, such as a saline solution, to preserve the integrity of lens 108. Lid 106 is exemplary in that additional embodiments can utilize other sealing mechanisms.

[0019] Referring to FIG. 2, a perspective view of exemplary insert 104 is provided. Additionally, top and bottom views of insert 104 are provided in FIGS. 3 and 4. In at least some embodiments, insert 104 includes a base 1 10 and a support structure 112 extending from a base top surface 111. As shown in FIG. 2, support structure 112 comprises a first support arm 114 and a second support arm 1 16, configured to secure lens 108 (not shown in FIG. 2). First support arm 114 includes a first exterior wall 118, which extends from base 110 at a first lower portion 120 of first support arm 114 to a first upper portion 122 of first support arm 114. First exterior wall 118 further extends in a U-shape or "C"-shape from an insert front side 124 to an insert back side 126. Similarly, second support arm 116 includes a second exterior wall 128, which extends from base 110 at a second lower portion 130 to a second upper portion 132. Second exterior wall 128 extends in a U-shape or "C"-shape from an insert front side 124 to an insert back side 126. In at least some embodiments, first support arm 114 and second support arm 116 can be configured in different shapes.

[0020] The opposing U-shaped configuration of first exterior wall 118 and second exterior wall 128 form a partially enclosed support compartment 138 for receiving and securing lens 108 to insert 104. In this configuration, a slot 133 is formed that extends between a front gap 134 and a back gap 136 (FIG. 3), wherein gaps 134, 136 are situated between first support arm 114 and second support arm 116. Slot 133 extends in a direction along a horizontal base axis 135 (FIG. 3). The insert 104 configuration provides a secure environment for lens 108, while offering an ergonomic shape that assists a user with safe and efficient removal of lens 108, either manually or mechanically. Gaps 134, 136 also permit any liquid present within container 102 (not shown) to flow around and between support arms 114, 116 to protect a lens and to keep it hydrated.

[0021] To assist with guiding lens 108 during insertion into insert 104, first and second arm top surfaces 140, 142 are ramped slightly downward (best seen in FIG. 5), relative to the horizontal, as they extend from their respective exterior walls 118, 128 towards a vertical center axis 150 (FIG. 5) of insert 104. First and second arm top surfaces 140, 142 engage and support the underside of removable lid 106 so as to reduce the possibility of breakage. First and second support arms 114, 116 include first and second interior walls 144, 146, respectively, that extend from first and second arm top surfaces 140, 142 to base top surface 11 1. In addition, at first and second upper portions 122, 132, first and second interior walls 144, 146 taper downward and outward towards vertical center axis 150. This also assists with inserting lens 108 into support compartment 138. The downward ramping of first and second arm top surfaces 140, 142 and the tapering of first and second interior walls 144, 146 at first and second upper portions 122, 132 can serve to limit the occurrence of misplacement and/or damage to lens 108 during insertion into support compartment 138.

[0022] Referring to FIG. 5, a front section view of insert 104 taken along line A- A of FIG. 3 is provided. In at least some embodiments, to further assist with insertion and securement of lens 108, first and second branches 160, 162 extend from first and second interior walls 144, 146, respectively. First and second branches 160, 162 can be integrally formed with their respective first and second interior walls 144, 146, or formed separately therefrom and secured thereto. First and second branches 160, 162 ramp downward and towards vertical center axis 150. At vertical center axis 150, first and second branches 160, 162 join together to form a base cavity 166 having a base cavity top surface 168 and base cavity bottom surface 170. The downward extending conical geometry of support compartment 138 provided by first and second branches 160, 162, provide support for vertical placement of lens 108 and allows for ergonomic removal of lens 108 by a user or machine. Lens outer perimeter 107 can abut first and second branches 160, 162 to assist with securement of lens 108. In addition, anchor 109 can abut base cavity top surface 168 to assist with supporting lens 108 in a position that limits or prevents distortion of lens outer perimeter 107 by over-insertion against first and second branches 160, 162.

[0023] In at least some embodiments, angle a of first branch 160, with respect to first interior wall 144, equals about 17 degrees, while in other embodiments, angle a can range from about 0 degrees to about 90 degrees, in yet additional embodiments, angle a can be selected to accommodate the chosen dimensions of lens 108. In at least some embodiments, angle β of second branch 162, with respect to second interior wall 146, equals about 17 degrees, while in other embodiments, angle β can range from about 0 degrees to about 90 degrees, in yet additional embodiments, angle β can be selected to accommodate the chosen dimensions of lens 108.

[0024] As discussed above, container 102 is configured to receive and secure insert 104. To accommodate insertion into container 102, insert 104 includes a size and shape that is complimentary to at least a portion of container 102. As shown in FIGS. 2-5, base 110 includes a base perimeter wall 180 extending between base top surface 11 1 and a base bottom surface 182. In at least some embodiments, perimeter wall 180 is rectangular in shape, while in other embodiments, perimeter wall 180 can include one of various shapes, such as round, square, oval, pentagonal, etc. Perimeter wall 180 includes a front wall 172, a back wall 174, a first side wall 176, and a second side wall 178 (see FIG. 3).

[0025] In at least some embodiments, perimeter wall 180 extends vertically parallel to vertical center axis 150, although in other embodiments, perimeter wall 180 can by tapered or otherwise non-parallel to vertical center axis 150. Additionally, in at least some embodiments, base bottom surface 182 can be flat and continuous as it extends between walls 172, 174, 176, 178, while in other embodiments (e.g., FIG. 4), base bottom surface 182 can be discontinuous as a result of one or more mold gaps 190. In at least some embodiments, perimeter wall 180 includes one or more protrusions or recesses (not shown) configured to engage one or more protrusions or recesses inside container 102 to provide engagement therebetween to secure insert 104 in container 102.

[0026] Referring to FIG. 6, a front perspective view of container 102 is provided. Outer wall 200 is in at least some embodiments circular, although in other embodiments it can include various other shapes, such as square, rectangular, pentagonal, etc. Outer wall 200 extends between a container bottom 202 and a flanged container top 204. Container top 204 further includes a flange top upper surface 205 and a flange sealing portion 206 configured to receive and releasably secure lid 106, as seen in FIG. 7, which illustrates a side view of container 102 with lid 106 secured to flange sealing portion 206. Lid 106 is sized and shaped to cover and seal a container opening 210, which is outlined by an opening perimeter 212. Lid 106 can further include a grasping tab portion 214 that extends beyond flange sealing portion 206 to assist a user with removal of lid 106. In at least some embodiments, tab portion 214 can extend or be extendable from lid 106 in other manners without extending beyond flange sealing portion 206.

[0027] Referring again to FIG. 6, outer wall 200 includes a top wall portion 216 and a bottom wall portion 218. Portions 216, 218 are joined (e.g., integrated, connected, merged, etc.) at a circumferential raised edge 220 to provide a greater circumference around bottom wall portion 218 with respect to top wall portion 216. That arrangement, which is optional, provides additional stability to container 102 during placement and removal of lid 106 and generally during container usage. Container 102 further includes one or more ridges, such as a first ridge 222 and a second ridge 224. First and second ridges 222, 224 extend along at least one of top and bottom wall portions 216, 218. In at least some embodiments, first and second ridges 222, 224 also extend from a flange top lower surface 225 to a container wall bottom surface 202, while in other embodiments, first and second ridges 222, 224 may not extend fully to container top 204 and/or container wall bottom surface 202. In at least some embodiments, first and second ridges 222, 224 are separated by 90 degrees along the circumference of outer wall 200, while in other embodiments, they can be separated by various other values of degrees as desired to accommodate design criteria. First and second ridges 222, 224 can serve various functions, such as providing grip points for securing container 102 when removing lid 106. Further, in at least some embodiments, first and second ridges 222, 224 can extend vertically, substantially vertically, or angled at least partially off the horizontal to provide some vertical component to resist rotational movement when engaged by a device, as discussed below. In addition, first and second ridges 222, 224 can extend to varied lengths.

[0028] Edge 220 and container top 204 can be utilized to provide clamping points that limit or prevent vertical movement of container 102. Likewise, first and second ridges 222, 224 can provide clamping points to limit or prevent rotational movement of container 102. In this regard, container 102 can be fully secured both rotationally and vertically to provide static and precise positioning. In addition, first and second ridges 222, 224 can serve as go/no-go gauges during manufacturing of apparatus 100. More particularly, first and second ridges 222, 224 can be used as markers to accurately align container 102 or to confirm alignment of container 102, to provide repeatable insertion of insert 104 into container 102, or lens 108 into insert 104 if already positioned in container 102. In addition, first and second ridges 222, 224 identify the orientation of lens 108 inside container 102, which can assist with manufacturing as well as provide non-destructive identification of lens 108 orientation to a handler of apparatus 100.

[0029] Referring to FIGS. 8 and 9, top and bottom views of container 102 are respectively provided. Container 102 is configured to matingly receive insert 104 substantially inside a central container cavity 230. Container cavity 230 can include numerous configurations capable of accommodating insert 104. In at least some embodiments, container 102 includes a plurality of planar and arcuate walls that can include various recesses, protrusions, indents, shelves, etc. More particularly, in at least one embodiment, as shown in FIG. 8, opposing first and second cavity walls 232, 234 are provided that extend vertically from a container cavity bottom surface 235 to a horizontal first shelf 238 and a horizontal second shelf 240, respectively. First and second shelves 238, 240 are joined to container top 204 by a first sloped portion 250 and a second sloped portion 252, respectively. First and second cavity walls 232, 234 are sized and shaped to complement front wall 172 and back wall 174 of base 110, to allow insert 104 to be complementarily installed into container cavity 230. In at least some embodiments, first and second cavity walls 232, 234 are sized and/or shaped to provide an interference fit with base 110 (e.g., base perimeter wall 180), to at least partially secure insert 104 to base 110. For example, first and second cavity walls 232, 234 can be spaced apart by a distance less than the width of base 110. Container wall bottom surface 202 is in communication with an exterior cavity bottom surface 236, which in combination with container wall bottom surface 202, substantially forms the bottom of container 102.

[0030] FIG. 10 is a section view taken along line B-B in FIG. 8. FIG. 10 shows in greater detail the interior features of container 102 discussed above with respect to FIGS. 8 and 9. Container cavity 230 further includes a third cavity wall 260 and a fourth cavity wall 262. Third and fourth cavity walls 260, 262 are joined to container top 204 by a third sloped portion 264 and a fourth sloped portion 266, respectively. First cavity wall 232 is connected to third cavity wall 260 via a curved fifth wall 270 and to fourth cavity wall 262 via a curved sixth wall 272. Similarly, second cavity wall 232 is connected to third cavity wall 260 via a curved seventh wall 276 and to fourth cavity wall 262 via a curved eighth wall 278. Cavity walls 232, 234, 260, 262, 270, 272, 276, 278, along with container cavity bottom 235, serve to substantially define container cavity 230.

[0031] The configuration of cavity walls 232, 234, 260, 262, 270, 272, 276, 278 allow for the shape of container cavity 230 to accommodate a plurality of mating configurations. More particularly, container cavity 230 can be configured to receive and secure a plurality of inserts 104 with varied shapes and sizes. In this regard, equally manufactured containers 102 can be used for securing and storing multiple product types. Insert 104 can be removed from container 102 and lens 108 subsequently removed from insert 104 for manual insertion into a patient's eye.

[0032] The aforementioned components can be comprised of various materials suitable for achieving manufacturing efficiencies, product securement, transport, and proper interaction with an ophthalmic device. In at least some embodiments, container 102 is comprised of medical grade gamma stable polypropylene, while in other embodiments, various other and/or additional types of plastic composites can be utilized. In at least some embodiments, lid 106 is comprised of an aluminum composite material, while in other embodiments, various other materials can be utilized, such as coated pulp products, etc. In at least some embodiments, insert 104 is comprised of an acrylic material, while in other embodiments, various other materials can be utilized. As mentioned above, a liquid solution is provided inside container 102 to protect and preserve lens 108, therefore, the materials utilized are typically waterproof or water resistant. [0033] The size and shape of the aforementioned components can vary to accommodate numerous design criteria for various ophthalmic devices. It is specifically intended that the method and apparatus for securement of ophthalmic devices not be limited to the embodiments and illustrations contained herein, but include modified forms of those embodiments including portions of the embodiments and combinations of elements of different embodiments as come within the scope of the following claims.

Claims

1. An insert for securing an ophthalmic device comprising:

a base having a base top surface, a base perimeter wall, and a vertical center axis extending therethrough;

one or more support arms extending vertically from the base top surface, wherein the one or more support arms include one or more respective interior walls; and

one or more branches extending from the one or more interior walls; wherein the one or more branches and one or more support arms combine to form a support compartment for receiving and securing at least a portion of an ophthalmic device.

2. The insert of claim 1 , wherein the one or more support arms include a first support arm and a second support arm, wherein the first support arm includes a first interior wall of the one or more interior walls and the second support arm includes a second interior wall of the one or more interior walls.

3. The insert of claim 2, wherein the one or more branches include a first branch extending from the first interior wall and a second branch extending from the second interior wall.

4. The insert of claim 3, wherein at least one of the first interior wall and second interior wall is ramped downward towards the base top surface.

5. The insert of claim 4, further including a base cavity substantially centered about a vertical center axis and having a base cavity top surface formed at least in part by the first and second branches and situated proximate the base top surface.

6. The insert of claim 5, wherein a portion of a lens anchor extending from a lens outer perimeter is positioned against the base cavity top surface.

7. A container for receiving and storing an ophthalmic device comprising:

a circumferential outer wall interconnecting a container bottom and a container top, wherein the circumferential outer wall includes a top wall portion interconnected to a bottom wall portion at a circumferential raised edge; one or more substantially vertical ridges extending along the outer wall between the container bottom and the container top wherein the one or more ridges are situated substantially perpendicular to the raised edge; and

a central container cavity bordered at least in part by a plurality of cavity walls situated interior of the outer wall, wherein the plurality of cavity walls extend at least indirectly between the container top and a container cavity bottom, and wherein the plurality of cavity walls are configured to receive a complimentarily-shaped lens insert.

8. The container of claim 7, wherein the plurality of cavity walls are configured to accommodate a choice of one of at least two distinct complimentarily-shaped lens inserts.

9. The container of claim 8, wherein the plurality of cavity walls includes a first cavity wall and a second cavity wall, wherein the first cavity wall and second cavity wall are spaced apart to provide an interference fit with the lens insert.

10. The container of claim 9, further including a lid removably secured to the container top for securing the lens insert inside the central container cavity.

11. The container of claim 10, further including a sterile liquid solution enclosed by the central container cavity and the lid.

12. An apparatus for securing and storing an ophthalmic device comprising:

an insert comprising:

a base having a base top surface, a base perimeter wall, and vertical center axis extending therethrough; one or more support arms extending vertically from the base top surface, wherein the one or more support arms include respective interior walls; and

one or more branches extending from the one or more interior walls; wherein the first one or more branches and one or more support arms combine to form a support compartment for receiving and securing at least a portion of an ophthalmic device; and

a container comprising: a circumferential outer wall interconnecting a container bottom and a container top, wherein the circumferential outer wall includes a top wall portion integrated with a bottom wall portion at a circumferential raised edge;

one or more ridges extending along the outer wall and downwards between the container bottom and the container top; and

a central container cavity bordered at least in part by a plurality of cavity walls situated interior of the outer wall, wherein the plurality of cavity walls extend at least indirectly between the container top and a container cavity bottom, and wherein the plurality of cavity walls are configured to receive the insert.

13. The apparatus of claim 12, wherein the central container cavity is configured to enclose a liquid solution and a lid is sealed to the container top after placement of both of the liquid solution and the insert into the central container cavity.

14. A method for securing an ophthalmic device comprising:

providing an insert having a support compartment for receiving at least a portion of an ophthalmic device;

providing a container comprising:

a circumferential outer wall interconnecting a container bottom and a container top; a top wall portion integrated with a bottom wall portion at a circumferential raised edge, wherein the top wall portion and bottom wall portion combine to form the outer wall;

one or more vertical ridges extending along the outer wall between the container bottom and the container top, wherein the ridges are situated substantially

perpendicular to the raised edge; and a central container cavity situated interior of the outer wall and configured to receive the insert; securing the container between the container top and the raised edge to at least one of prevent or substantially prevent vertical movement of the container;

securing the container along at least one of the one or more vertical ridges to at least one of prevent or substantially prevent rotational movement of the container; inserting the insert into the central container cavity of the container; filling the container cavity with a solution; and

securing a lid to the container top to secure the insert and solution inside the container.

15. The method of claim 14, wherein the insert further includes a first support arm and a second support arm, each extending vertically from the base top surface, wherein the first support arm includes a first interior wall and the second support arm includes a second interior wall.

16. The method of claim 15, further including a first branch extending from the first interior wall and a second branch extending from the second interior wall, wherein the first branch, second branch, first interior wall, and second interior wall together form the support compartment.

17. The method of claim 14, further including removing the lid to access the insert and subsequently removing the insert and the ophthalmic device for insertion in a patient's eye.

18. The method of claim 14, wherein the central container cavity is enclosed at least in part by a plurality of cavity walls that extend at least indirectly between the container top and a container cavity bottom.

19. The method of claim 18, wherein the solution is a liquid saline solution.

20. The method of claim 14, wherein the ophthalmic device is an intraocular lens.