WO2020167647A1

WO2020167647A1 - Improved cartridge for an intraocular lens

Info

Publication number: WO2020167647A1
Application number: PCT/US2020/017475
Authority: WO
Inventors: Ravi Nallakrishnan
Original assignee: Nallakrishnan Family Trust
Priority date: 2019-02-11
Filing date: 2020-02-10
Publication date: 2020-08-20

Abstract

A cartridge for an intraocuiar lens includes a hollow base body has proximal and distal ends, a generally radially-extending aperture located on a first longitudinal side of the base body, and defines a curved interior surface facing the aperture. The cartridge includes a case arranged on a second longitudinal side of the base body opposite the first longitudinal side. The case extends radially outwardly from the base body and includes a ventilation window therein. A sliding element is received within the aperture and has a lens support surface for receiving an intraocular lens. The sliding element includes (i) an open configuration wherein the lens support surface is exposed to receive an intraocular lens; and (ii) a closed configuration wherein the lens support surface extends into the case such that an intraocular lens resting on the lens support surface contacts the curved interior surface to roll or fold the lens.

Description

IMPROVED CARTRIDGE FOR AN INTRAOCULAR LENS

CROSS-REFERENCES TO RELATED APPLICATIONS

[0001] This application claims priority of U.S. provisional patent application Serial No. 62/803,845, filed on February 11 , 2019, which is incorporated here by reference in its entirety to provide continuity of disclosure, and applicant claims the benefit of that prior application.

FIELD OF THE INVENTION

[0002] The present invention relates generally to the field of

ophthalmic surgery, and more particularly, to a cartridge for use during the implantation of an intraocular lens into the human eye.

BACKGROUND OF THE INVENTION AND TECHNICAL PROBLEMS POSED BY THE PRIOR ART

[0003] Removal of a lens in an eye is required by such physical conditions as cataracts, disease, or trauma to the eye. Typically, the removal of the lens is accomplished by making an opening in an anterior wall of a capsule that contains the lens, and then using surgical techniques such as phacoemulsification to fragment and aspirate the fragmented lens pieces. Thereafter, an artificial intraocular lens (IOL) is inserted through the opening in the lens capsule to replace the damaged or diseased lens.

[0004] In order to reduce the trauma to the eye, the IOL is typically folded, rolled, or compressed into a container or cartridge which is either assembled with a plunger type mechanism or which is an integral part of a plunger type system. The cartridge typically has a proximal, open end and a tapered, distal end. The plunger type mechanism or system has movable plunger that enters the proximal, open end of the cartridge to contact the folded or compressed IOL within the cartridge to force the IOL out through a tapered, distal end. The tapered, distal end of the cartridge is suited to be inserted through a small incision in the cornea of the eye. The IOL expands within the eye upon exiting the tapered, distal end of the cartridge.

[0005] One such prior art cartridge is described in United States Patent No. 7,476,229 B2, the disclosure of which is incorporated herein by reference in its entirety. Another such prior art cartridge is designated as the Monarch cartridge and is sold by Aicon, having an office in Fort Worth,

Texas.

[0006] The inventor has found that there remains a need for improved sterilization of the IOL cartridges. Furthermore, some cartridges present difficulties with respect to handling and loading of the IOL into the cartridge.

[0007] There remains a need for an improved cartridge that is suitable for assembly with a variety of injectors and for use with a variety of lOLs.

[0008] There remains a need for an improved cartridge that is more easily mass-produced and less expensive to manufacture.

[0009] It would be desirable to provide an improved cartridge wherein the above-discussed problems could be eliminated, or at least substantially minimized. SUMMARY OF THE INVENTION

[0010] The inventor of the present invention has determined how to provide an inventive cartridge for an intraocular lens, the cartridge for use with an injector. In one form, the cartridge includes a hollow base body which defines a central longitudinal axis and which has a proximal, open end and a distal end. The base body has a generally radially-extending aperture located on a first longitudinal side of the base body. The base body defines a curved interior surface that faces the aperture.

[0011] The cartridge further includes a case arranged on a second longitudinal side of the base body at a location opposite of the first longitudinal side. The case extends generally radially outwardly from the base body. The case includes at least one ventilation window therein

[0012] The cartridge also includes a sliding element that is slidably- received within the aperture and has a lens support surface for receiving an intraocular lens. The sliding element includes at least the two following configurations: (i) an open configuration wherein the lens support surface is exposed to receive an intraocular lens; and (ii) a closed configuration wherein the lens support surface extends into the case such that an intraocular lens resting on the lens support surface contacts the curved interior surface to roll or fold the lens.

[0013] In another form of the Invention, the cartridge distal end is tapered along the central longitudinal axis.

[0014] in yet another form of the invention, cartridge distal end is angled and defines a leading edge and a trailing edge. [0015] In still another form of the invention, the cartridge case has a plurality of ventilation windows. Preferably the ventilation window or windows in the case is/are located on a top surface of the case— the top surface being located opposite of the lens support surface of the sliding element when the sliding element is located in its closed configuration within the case.

[0016] According to another form of the invention, the cartridge sliding element is slidable along a radial axis that is perpendicular to the central longitudinal axis of the base body.

[0017] According to yet another form of the invention, the cartridge further includes a removable cover that is removably attached to the sliding element when the sliding is in its open configuration. In one preferred form, the removable cover includes at least one snap-fit projection for attaching the cover to the sliding element. In another preferred from, the cover includes one or more ventilation window located above the lens support surface when the sliding element is in its open configuration and the cover is attached to the sliding element.

[0018] In still another form of the present invention, the cartridge as recited base body is generally cylindrical along the central longitudinal axis.

[0019] According to another form of the present invention, the cartridge as sliding element includes a raised end wall that extends above the lens support surface.

[0020] In another form of the present invention, the cartridge sliding element includes an arcuate outer surface that is substantially flush with the base body when the sliding element is located in its closed configuration. [0021] According to one aspect of the present invention, the cartridge as is in combination with an intraocular lens located on the lens support surface with the sliding eiement located in its closed configuration.

[0022] in still another form of the invention, the cartridge is provided in combination with an injector with the cartridge removably assembled with the injector. The injector is of the type having a movable plunger. In one preferred form of the invention, the plunger includes an elastomeric sleeve fitted around a distal end of the plunger for contacting an intraocular lens stored within the cartridge.

BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In the accompanying drawings forming part of the

specification, in which like numerals are employed to designate like parts throughout the same:

Fig. 1 is an enlarged, isometric view of a first illustrated embodiment of a cartridge according to the present invention;

Fig. 2 is a greatly enlarged, isometric view of the cartridge shown in Fig. 1 , and Fig. 2 shows a removable cover lifted away from an !OL resting surface of a cartridge siiding eiement;

Fig. 3 is an enlarged, isometric view of the cartridge shown in Fig. 1 , and Fig. 3 shows the tapered, distal end of the cartridge base body;

Fig. 4 is another greatly enlarged, isometric view of the cartridge shown in Fig. 1 , and Fig. 4 shows a removable cover lifted away from the IOL resting surface of the cartridge sliding eiement; Fig 5 is an enlarged, cross-sectional view of the cartridge shown in Fig. 1 taken through the central longitudinal axis of the cartridge, and Fig. 5 shows the removable cover completely removed and an IOL resting on the surface of the cartridge sliding element;

Fig. 6 is an enlarged, top plan view of the cartridge shown in Fig. 1 ;

Fig. 7 is another enlarged, top plan view of the cartridge shown in Fig

1 ;

Fig. 8 is an enlarged, isometric view of a second illustrated

embodiment of a cartridge according to the present invention;

Fig. 9 is an enlarged, top plan view of the cartridge shown in Fig. 8, and Fig. 9 an IOL resting on the surface of the cartridge sliding element;

Fig. 10 is another enlarged, top plan view of the cartridge shown in Fig. 8; and

Fig. 11 is a partial exploded view of injector plunger and optional elastomeric sleeve for use with the cartridges of the present invention.

DETAILED DESCRIPTION OF THE DRAWINGS

[0024] While the following describes a preferred embodiment or embodiments of the present invention, it is to be understood that this description is made by way of example only and is not intended to limit the scope of the present invention. It is expected that alterations and further modifications, as well as other and further applications of the principies of the present invention will occur to others skilled in the art to which the invention relates and, while differing from the foregoing, remain within the spirit and scope of the invention as herein described and claimed. [0025] Referring now to Figs. 1-7, a first embodiment of a cartridge according to the present invention is illustrated. The cartridge includes a central body or base body 20. The base body 20 is hollow and defines a central longitudinal axis“A” that extends through the center of the base body 20 from a proximal, open end 24 (simply referred to as“proximal end" hereinafter) and a distal, open end 28 (simply referred to as“distal end” hereinafter). As best viewed in Fig. 8, the distal end 28 is beveled or angled to define a leading edge 29a and a trailing edge 29b, the trailing edge 29b located proximally along the axis“A” relative to the leading edge 29a. The angle a (Fig. 7) of the bevel is preferably between about 20 and 45 degrees relative to a plane that is perpendicular to the central longitudinal axis“A”. In some forms of the present invention, the distal end 28 may be straight, without any angle or bevel. The proximal end 24 is sized to receive a distal end of an injector plunger, which may drive a folded intraocular lens along the axis“A” and out of the distal end 28 during operation, which will be discussed in detail hereinafter.

[0026] Referring to Figs. 1 and 5, the base body 20 is generally cylindrical and has a generally radially-extending slot or aperture 32 on a first longitudinal side of the axis“A”, and further includes a cylindrical or curved interior surface 36 that faces or is located opposite the aperture 32. A hollow case 40 is arranged on a second longitudinal side of the base body 20, opposite of the first longitudinal side, and opens into the base body 20 interior below the curved interior surface 36. The case 40 has a generally rectangular upper surface 41 and extends generally radially outwardly from the base body 20. A tray or sliding element 44 is s!idab!y-received within the aperture 32 and may extend beneath the curved interior surface 36 into the open side of the case 40, sliding along a secondary axis“B” that is substantially perpendicular to the central longitudinal axis“A”.

[0027] Still referring to Figs. 1 and 5, the sliding element 44 Includes a raised end wall or lip 48 having an outer surface 47 that is flush against the base body 20 when the sliding element 44 is received fully within the case 40. The outer surface 47 is arcuate to conform to the cylindrical outer surface of the base body 20, but it will be understood that the outer surface 47 may have other shapes, such as flat, polygonal, or irregular shapes if the base body 20 has an outer surface with a different shape. The sliding element 44 further includes a lens support surface 48 for receiving an intraocular lens (e.g., as shown in Fig. 5, as will be discussed below) and has an open configuration wherein the Sens support surface 48 is exposed to receive an intraocular lens, and a closed configuration wherein the lens support surface 48 extends into the case 40 and an intraocular lens on the lens support surface 48 contacts the curved interior surface 38. Movement of the sliding element 44 into the case 40 forces an intraocular lens resting on the lens support surface 48 against the curved interior surface 36 to roll, fold, or compress the lens within the hollow base body 20 for subsequent implantation within the eye.

[0028] As can be seen in Figs. 1 and 2, the end wall 46 is raised above the resting surface 48 to sea! the aperture 32 when the sliding element 44 is pushed fully into the case 40. The recessed positioning of the resting surface 48 permits the sliding element 44 to slip beneath the curved interior surface 36.

[0029] Referring now to Fig. 5, the top surface 41 of the case 40 is provided with a plurality of holes or ventilation windows 50. The inventor has found that the ventilation windows 50 located in the case 40 may provide improved sterilization of the cartridge before or after use. The ventilation windows 50 further provide an indication to a user of the cartridge that the intraocular lens has been properly folded against the curved interior surface 38 when the sliding element 44 is pushed into the closed configuration within the case 44.

[0030] Referring now to Figs. 1 and 2, the cartridge is further provided with a removable cover 60. The cover 60 can be removably attached to the sliding element 44 with two pairs of snap-fit projections or beads 82, when the sliding element 44 is located in its open configuration extending out of the base body 20. It will be understood that the cover 60 may be attached by other means such as friction fit surfaces, posts, locking tabs, frangible elements, etc. The cover 80 must be lifted away from the sliding element 44 (Fig. 2) to expose the resting surface 48. The cover 60 prevents the premature movement of the sliding element 44 Into the case 40. Premature loading of the IOL into the hollow base body 20 could negatively impact the performance of the IOL after implantation, for example, the IOL may exhibit creep or permanent deformation if it is maintained in the rolled or

compressed position for a long period of time prior to implantation within the eye.

[0031] Operation of the cartridge will now be discussed. The cartridge is preferably manufactured or otherwise formed from a surgical grade polymer that may be repeatedly used and sterilized by any conventional or special means (e.g., gas or heat). The cartridge may be preioaded with an IOL, such as the roilable-type IOL 100 (Fig. 5) or an IOL 100 may be loaded onto the resting surface 48 by a user with the sliding element 44 in its open configuration. The user must lift the removable cover 60 away from the sliding element 44 to either expose the IOL 100 or expose the resting surface 48 for the loading of an IOL 100. The IOL 100 may be loaded onto the resting surface 48 by a suitable instrument such as forceps.

[0032] With the cover 60 fully removed and an IOL 100 resting upon the resting surface 48, the user may press against the end wail 46 to drive the sliding element 44 along the radial axis“B” and into the case 40.

Movement of the sliding element 44 into the case 40 conveys the IOL 100 toward and against the curved interior surface 36 to roil the IOL 100 into a generally cylindrical, collapsed state. The sliding element 44 extends fully info the case 40 such that the curved outer surface 47 is flush with the base body 20.

[0033] The cartridge may be assembled (either before or after the rolling of the IOL 100 within the cartridge) with a plunger-type injector or system, such as the injector 110 illustrated in Fig. 1 1. Prior art injectors of this type are disclosed in U.S. Patent No. 7,097,649, which is incorporated herein by reference in its entirety. The injector contains a movable plunger 120 that may be driven relative to the cartridge through the proximal end 24 and against the folded IOL 100 to drive the IOL 100 through the base body 20 and out of the distal end 28.

[0034] The distal end 28 may be placed through an incision in the cornea of the eye, whereby the IOL 100 may re-expand or unfold within the lens capsule of the eye after the natural lens of the eye has been removed. An elastomeric sleeve 130 may be fitted around the operative, distal end of 120 to gently press against the IOL 100 in the cartridge. [0035] Referring next to Figs. 8-10, another embodiment of the inventive cartridge is illustrated. The second embodiment of the cartridge functions in substantially the same manner as the first illustrated embodiment discussed above. However, the second illustrated embodiment of the cartridge includes a plurality of ventilation windows 50A that are located in the cover 80. The ventilation windows 50A are located over the lens resting surface 48 when the cover 80 is assembled with the sliding element 44. The ventilation windows 50A function to enhance sterilization of the cartridge when compared to the first embodiment.

[0036] It will be appreciated that the ventilation windows 50 and/or 50A may have other non-circular shapes, such as polygons slots, or irregular or non-uniform shapes.

[0037] It will further be appreciated that the cartridge according to the present invention may be provided with a removable cover 60, which reduces the vertical height of the sliding element 44, which assists in the sliding functionality between the open and closed configurations, and such a cartridge need not be provided with any ventilation windows 50 and/or 50A.

In such an embodiment, the cartridge need not be reusable and instead could be disposable.

[0038] It will be appreciated that while various theories and

explanations have been set forth herein with respect to how the frame portions of the retractor operate, there is no intention to be bound by such theories and explanations. Further it is intended that all structures falling within the scope of the appended claims are not to be otherwise excluded from the scope of the claims merely because the operation of such structures may not be accounted for by the explanations and theories presented herein.

Claims

In the Claims:

1. A cartridge for an intraocular lens for use with an injector, said cartridge comprising:

a hollow base body (20) defining a central longitudinal axis (A) and having a proximal, open end (24) and a distal end (28), said base body (20) having a generally radially-extending aperture (32) on a first longitudinal side of said base body (20), said base body (20) defining a curved interior surface (36) facing said aperture (32);

a case (40) arranged on a second longitudinal side of said base body (20) opposite of said first longitudinal side, said case (40) extending generally radially outwardly from said base body (20), said case (40) having at least one ventilation window (50) therein; and

a sliding element (44) that is slidably-received within said aperture (32), said sliding element (44) having a lens support surface (48) for receiving an intraocular lens, said sliding element (44) having

(i) an open configuration wherein said lens support surface (48) is exposed to receive an intraocular lens, and

(ii) a closed configuration wherein said iens support surface (48) extends into said case (40) and an intraocular lens on said lens support surface (48) contacts said curved interior surface (36).

2. The cartridge as recited in claim 1 wherein said distal end (28) is tapered.

3. The cartridge as recited in claim 1 wherein said distal end (28) is angled and defines a leading edge and a trailing edge.

4. The cartridge as recited in claim 1 wherein said at least one ventilation window (50) has the form of a plurality of ventilation windows (50).

5. The cartridge as recited in claim 1 wherein said at least one ventilation window (50) is located on a top surface (41) of said case (40), said top surface (41) located opposite of said lens support surface (48) with said sliding element (44) located in said closed configuration.

6. The cartridge as recited in claim 1 wherein said sliding element (44) is slidable along a radial axis (B) that is perpendicular to said central longitudinal axis (A).

7. The cartridge as recited in claim 1 further comprising a removable cover (60) removably attached to said sliding element (44).

8. The cartridge as recited in claim 7 wherein said removable cover (60) includes at least one snap-fit projection (62) for attaching said cover (60) to said sliding element (44).

9. The cartridge as recited in claims 7 wherein said removable cover (60) includes at least one ventilation window (50A) located above said lens support surface (48) when said sliding element is in said open configuration.

10. The cartridge as recited in claim 1 wherein said base body (20) is generally cylindrical along said central longitudinal axis (A).

1 1. The cartridge as recited in claim 1 wherein sliding element (44) includes a raised end wall (46) that extends above said lens support surface (48).

12. The cartridge as recited in claim 1 wherein sliding element (44) includes an arcuate outer surface (47) that is substantially flush with said base body (20) with said sliding element (44) located in said closed configuration.

13. The cartridge as recited in claim 1 in combination with an intraocular lens (100) located on said lens support surface (48) with said sliding element (44) located in said closed configuration.

14. The cartridge as recited in claim 1 in combination with an injector (1 10), said cartridge assembled with said injector (110), said injector (110) including a movable plunger (120).

15. The combination as recited in claim 14 wherein said movable plunger (120) includes an elastomeric sleeve (130) around a distal end of said plunger (120).

16. A cartridge for an intraocular lens for use with an injector, said cartridge comprising:

a hollow base body (20) defining a central longitudinal axis (A) and having a proximal, open end (24) and a distal end (28), said base body (20) having a generally radially-extending aperture (32) on a first longitudinal side of said base body (20), said base body (20) defining a curved interior surface (38) facing said aperture (32);

a case (40) arranged on a second longitudinal side of said base body (20) opposite of said first longitudinal side, said case (40) extending generally radially outwardly from said base body (20);

(ii) a closed configuration wherein said lens support surface (48) extends into said case (40) and an intraocular lens on said lens support surface (48) contacts said curved interior surface (38); and

a removable cover (60) removably attached to said sliding element (44), said removable cover (60) preventing said sliding element (44) from moving between said open configuration and said closed configuration when attached to said sliding element (44).

17. A cartridge for an intraocular lens for use with an injector, said cartridge comprising:

a hollow base body (20) defining a central longitudinal axis (A) and having a proximal, open end (24) and a distal end (28), said base body (20) having a generally radially-extending aperture (32) on a first longitudinal side of said base body (20), said base body (20) defining a curved interior surface (36) facing said aperture (32); a case (40) arranged on a second longitudinal side of said base body (20) opposite of said first longitudinal side, said case (40) extending generally radially outwardly from said base body (20), said case (40) has at least one ventilation window (50) therein; and

(ii) a closed configuration wherein said lens support surface (48) extends into said case (40) and an intraocular lens on said lens support surface (48) contacts said curved interior surface (36).

18. The cartridge as recited in claim 17 wherein said distal end (28) is

tapered.

19. The cartridge as recited in any of preceding claims 17-18 wherein said distal end (28) is angled and defines a leading edge and a trailing edge.

20. The cartridge as recited in any of preceding claims 17-19 wherein said case (40) has a plurality of ventilation windows (50).

21. The cartridge as recited in any of preceding claims 17-20 wherein said at least one ventilation window (50) is located on a top surface (41 ) of said case (40), said top surface (41 ) located opposite of said lens support surface (48) with said sliding element (44) located in said closed configuration

22. The cartridge as recited in any of preceding claims 17-21 wherein said sliding element (44) is slidable along a radial axis (B) that is perpendicular to said central longitudinal axis (A)

23. The cartridge as recited in any of preceding claims 17-22 further

comprising a removable cover (60) removably attached to said sliding element (44).

24. The cartridge as recited in claim 23 wherein said removable cover (60) includes at least one snap-fit projection (62) for attaching said cover (60) to said sliding element (44).

25. The cartridge as recited in any of preceding claims 23 or 24 wherein said removable cover (60) includes at least one ventilation window (50A) located above said lens support surface (48) when said sliding element is in said open configuration.

26. The cartridge as recited in any of preceding claims 17-25 wherein said base body (20) is generally cylindrical along said central longitudinal axis (A).

27. The cartridge as recited in any of preceding claims 17-26 wherein sliding eiement (44) includes a raised end wall (46) that extends above said lens support surface (48).

28. The cartridge as recited in any of preceding claims 17-27 wherein sliding element (44) includes an arcuate outer surface (47) that is substantially flush with said base body (20) with said sliding element (44) located in said closed configuration.

29. The cartridge as recited in any of preceding claims 17-28 in combination with an intraocular lens (100) located on said lens support surface (48) with said sliding element (44) located in said dosed configuration.

30. The cartridge as recited in any of preceding claims 17-29 in combination with an injector (110), said cartridge assembled with said injector (110), said injector (110) including a movable plunger (120).

31. The combination as recited in claim 30 wherein said movable plunger (120) includes an elastomeric sleeve (130) around a distal end of said plunger (120).

32. A cartridge for an intraocular lens for use with an injector, said cartridge comprising:

a hollow base body (20) defining a centra! longitudinal axis (A) and having a proximal, open end (24) and a distal end (28), said base body (20) having a generally radially-extending aperture (32) on a first longitudinal side of said base body (20), said base body (20) defining a curved interior surface (36) facing said aperture (32); a case (40) arranged on a second longitudinal side of said base body (20) opposite of said first longitudinal side, said case (40) extending generally radially outwardly from said base body (20);

(ii) a closed configuration wherein said lens support surface (48) extends into said case (40) and an intraocular lens on said lens support surface (48) contacts said curved interior surface (36); and

a removable cover (60) removably attached to said sliding element (44).