This invention relates to intraocular lens inserters, and more specifically to guiding structures in the cartridges for intraocular lens inserters.
The techniques of cataract surgery are experiencing continuous, impressive progress. Subsequent generations of phacoemulsification platforms and newly invented surgical lasers keep increasing the precision of the placement of intraocular lenses (IOLs), and keep reducing the unwanted medical outcomes.
In a typical cataract procedure, an IOL is placed and folded into a cartridge, which is then placed into a tip of an inserter. Subsequently, a nozzle of the cartridge at the tip of the inserter is inserted into an eye through a surgically created incision, reaching the capsule of the eye. Then the IOL is pushed out of the cartridge through an insertion channel by a push-rod into the eye-capsule, where it is positioned, oriented, and rotated according to the pre-surgical plan, and then stabilized.
The more precisely the IOL is placed in the eye-capsule, the better the medical outcome. The precision placement of the IOL involves placing the IOL to the planned location with the planned orientation, as determined during the pre-surgical planning process. This is especially important for high-end toric, diffractive, and aspheric IOLs, whose optical axes need to be aligned with the planned orientation within a few degrees to achieve the planned and promised vision correction.
In a typical cataract procedure, in order to minimize the length of the incision, the insertion nozzle of the cartridge is tapered and its diameter is made as small as possible. To make the IOL able to pass through this narrow and tapered insertion nozzle, the IOL is folded up and compressed substantially when it is placed into the cartridge. The gain associated with the narrowness of the insertion nozzle and the shortness of the incision, however, comes at a price, as the heavily compressed IOL tends to rotate while it is pushed through the tapered nozzle. Because of this rotation, the orientation of the IOL, and its haptics, after insertion often deviates from the surgically planned orientation. This is an undesirable outcome that undermines the medical benefit of the cataract procedure, especially when involving advanced IOLs, such as toric, diffractive, and aspheric IOLs, and any other intraocular lens designs, for which the orientation of the IOL or its haptic is important. Therefore, there is a profound need to reduce and potentially eliminate the rotation of the IOL as it is pushed along the insertion nozzle.
The above-described medical needs can be met by a cartridge of an intraocular lens inserter that comprises an insertion nozzle, having a distal insertion channel; an intra-ocular lens (IOL)-folding stage, to receive and to fold an IOL, proximal to the insertion nozzle, and having a proximal insertion channel; and an IOL-guiding structure. The IOL-guiding structure can include a first proximal guiding groove, or a first proximal guiding rib, or both, formed in the IOL-folding stage. In some embodiments, an intraocular lens inserter comprises an inserter cylinder; a push-rod, partially in the inserter cylinder; a cartridge-receiving insertion end, to receive a cartridge that includes an insertion nozzle, having a distal insertion channel; an IOL-folding stage, proximal to the insertion nozzle, having a proximal insertion channel; and an IOL-guiding structure.
This document describes embodiments of ophthalmic inserters and their cartridges that provide improvements regarding the above described medical needs.
A typical use of the inserter 100 can include the following steps. (1) The IOL 10 is placed, or loaded, and then folded into a cartridge 200. (2) The cartridge 200 is positioned into the cartridge-receiving tip 130 of the inserter 100. (3) A distal tip, or insertion nozzle, of the cartridge 200 is inserted into an eye through an incision, created earlier by the surgeon. (4)
As discussed earlier, there are clear medical benefits associated with inserting the IOL 10 into the capsule of the eye with a preferred, or predetermined, alignment and orientation. It is noted that it is not sufficient to load the IOL 10 into the cartridge 200 with the planned orientation, because the IOL 10 can, and often does rotate away from its preferred orientation as it is pushed through the small diameter distal end of the cartridge 200 by the push rod 110. This can lead to undesirable medical outcomes, such as the misalignment of the major meridians of an implanted toric IOL with the axis of astigmatism of the eye. This issue is of substantial importance, as even a few degree misalignment of a toric lens from a planned direction can lead to substantial discomfort for the patient. It is a recurring event that even a seemingly small misalignment is so bothersome that some patients ask for a second procedure to rotate the IOL, or possibly even to remove the IOL from the eye altogether. Especially in “patient-pay” procedures that promise high quality outcomes, such a surgical result is highly undesirable.
Embodiments of the here-described cartridge 200 are designed to reduce, to restrain, to minimize and possibly to eliminate this undesirable IOL rotation during the insertion process.
The IOL-guiding structure 240 can further include a second proximal guiding groove 240g-p2, also formed in the IOL folding stage 230, and a first distal guiding groove 240g-d1, formed distal to the IOL folding stage 230. In some embodiments, the first distal guiding groove 240g-d1 is formed as part of the insertion nozzle 210. In others, the first distal guiding groove 240g-d1 can be formed distal to the IOL folding stage 230, but proximal to the insertion nozzle 210, as shown in
The IOL-folding stage 230 can include a foldable IOL-folding wing 231, to partially receive the IOL 10, and a fixed IOL-folding wing 232, to partially receive the IOL 10. In some embodiments, the first proximal guiding groove 240g-p1 can be formed in the foldable IOL-folding wing 231, in other embodiments, in the fixed IOL-folding wing 232, or partially in both. In the illustrated examples, the first proximal guiding groove 240g-p1 will be shown formed in the foldable IOL-folding wing 231, but the mirrored embodiments, in which the first proximal guiding groove 240g-p1 is formed in the fixed IOL-folding wing 232 are also used in other embodiments.
In embodiments that have both the first proximal guiding groove 240g-p1, and the second proximal guiding groove 240g-p2, the first proximal guiding groove 240g-p1 can be formed in the foldable IOL-folding wing 231, and the second proximal guiding groove 240g-p2 can be formed in the fixed IOL-folding wing 232, so that both IOL-folding wings 231 and 232 have a proximal guiding groove 240g-p1 or 240g-p2. The fixed IOL-folding wing 232 can be fixed relative to the insertion nozzle 210.
A leading function of the guiding grooves 240g is to guide the IOL 10 during insertion, thus restraining and reducing an unintended rotation of the IOL 10. In some detail, the first proximal guiding groove 240g-p1 can be configured to catch an edge of the IOL 10 and then guide this edge during the insertion of the IOL 10, thereby restraining a rotation of the IOL 10 as it moves along the proximal insertion channel 220-p. To make the guiding firmer, embodiments of the cartridge 200 may include the second proximal guiding groove 240g-p2 that catches an opposite edge of the IOL 10. Such embodiments of the cartridge 200 can provide a firmer guidance and constrain the IOL 10 more efficiently from rotating during insertion. Some embodiments of the guiding grooves 240g can reduce, restrain, or constrain the rotation of the IOL 10 particularly efficiently. These embodiments can minimize and even prevent a rotation of the IOL 10 during insertion. The IOL 10 being round, an edge of the IOL 10 typically refers to a short first segment of the circular perimeter of the IOL 10, and an opposite edge can refer to a short second segment that is diagonally opposite to the first segment.
In some designs, the second proximal guiding groove 240g-p2, that is formed in the fixed IOL folding wing 232, can be longer than the first proximal guiding groove 240g-p1. In the embodiment of
In some embodiments, the first distal guiding groove 240g-d1 can be aligned with the first proximal guiding groove 240g-p1. In such embodiments, the guided edge of the IOL 10 can smoothly pass from the first proximal guiding groove 240g-p1 to the first distal guiding groove 240g-d1 as the push-rod 110 advances the IOL 10 from the proximal insertion channel 220-p into the distal insertion channel 220-d.
Next, another embodiment of the IOL-guiding structure 240 will be described.
As before, in some embodiments, the IOL-folding stage 230 can include the foldable IOL-folding wing 231, to partially receive the IOL 10, and the fixed IOL-folding wing 232, to partially receive the IOL 10. In some embodiments, the first proximal guiding rib 240r-p1 can be formed in the foldable IOL-folding wing 231. In others, the first proximal guiding rib 240r-p1 can be formed in the fixed IOL-folding wing 232. In the illustrated examples, the first proximal guiding rib 240r-p1 will be shown formed in the foldable IOL-folding wing 231, but the mirrored embodiments, in which the first proximal guiding rib 240r-p1 is formed in the fixed IOL-folding wing 232 are also used in other embodiments.
As shown in
Some embodiments can include two proximal guiding ribs 240r-p: the first proximal guiding rib 240r-p1, formed in the foldable IOL-folding wing 231, and a second proximal guiding rib 240r-p2, formed in the fixed IOL-folding wing 232, so that both IOL-folding wings 231 and 232 have a proximal guiding rib 240r-p1 and 240r-p2.
A leading function of the guiding ribs 240r-p1, 240r-p2, and 240r-d1 is to guide an edge of the IOL 10 during insertion. In some detail, the guiding ribs 240r-p1, 240r-p2, and 240r-d1 can be configured to protrude into the proximal insertion channel 220-p, and into the distal insertion channel 220-d to guide an edge of the IOL 10 during the IOL insertion, thereby reducing and restraining a rotation of the IOL 10 as it is pushed forward by the push rod 110 during insertion.
In embodiments that include both the first proximal guiding rib 240r-p1 and the first distal guiding rib 240r-d1, the first distal guiding rib 240r-d1 can be aligned with the first proximal guiding rib 240r-p1. In such embodiments, the caught edge of the IOL 10 can smoothly pass from the first proximal guiding rib 240r-p1 to the first distal guiding rib 240r-d1 as the push-rod 110 advances the IOL 10 from the proximal insertion channel 220-p to the distal insertion channel 220-d.
Finally, the IOL-guiding structure 240 can have other embodiments that combine the above designs. These embodiments may include one or more guiding grooves 240g-p1, 240g-p2, and 240g-d1, and one or more guiding ribs 240r-p1, 240r-p2, and 240r-d1 in various combinations. Having both guiding grooves 240g and guiding ribs 240r can make the overall IOL-guiding structure 240 more efficient in achieving its main function of reducing or controlling the rotation of the IOL 10 during insertion, as well as achieving its additional functions, such as assisting the IOL folding process.
While this document contains many specifics, details and numerical ranges, these should not be construed as limitations of the scope of the invention and of the claims, but, rather, as descriptions of features specific to particular embodiments of the invention. Certain features that are described in this document in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to another subcombination or a variation of a subcombinations.
Number | Name | Date | Kind |
---|---|---|---|
5474562 | Orchowski et al. | Dec 1995 | A |
5499987 | Feingold | Mar 1996 | A |
5653753 | Brady | Aug 1997 | A |
5800442 | Wolf | Sep 1998 | A |
5803925 | Yang | Sep 1998 | A |
5876440 | Feingold | Mar 1999 | A |
5947975 | Kikuchi | Sep 1999 | A |
6001107 | Feingold | Dec 1999 | A |
6129733 | Brady et al. | Oct 2000 | A |
6206887 | McDonald | Mar 2001 | B1 |
6248111 | Glick | Jun 2001 | B1 |
6283975 | Glick | Sep 2001 | B1 |
6355046 | Kikuchi et al. | Mar 2002 | B2 |
6447520 | Ott et al. | Sep 2002 | B1 |
6554839 | Brady | Apr 2003 | B2 |
6712848 | Wolf et al. | Mar 2004 | B1 |
6723104 | Ott | Apr 2004 | B2 |
6733507 | McNicholas | May 2004 | B2 |
8535331 | Vaquero et al. | Sep 2013 | B2 |
8551165 | Hohl | Oct 2013 | B2 |
8668734 | Hildebrand et al. | Mar 2014 | B2 |
9044317 | Hlidebrand et al. | Jun 2015 | B2 |
20020193805 | Ott | Dec 2002 | A1 |
20030050646 | Kikuchi | Mar 2003 | A1 |
20030176870 | Ott | Sep 2003 | A1 |
20030195522 | Mcnicholas et al. | Oct 2003 | A1 |
20040087963 | Ossipov et al. | May 2004 | A1 |
20040199174 | Herberger | Oct 2004 | A1 |
20040267359 | Makker | Dec 2004 | A1 |
20050065534 | Hohl | Mar 2005 | A1 |
20050149058 | Lin | Jul 2005 | A1 |
20060036262 | Hohl | Feb 2006 | A1 |
20060167466 | Dusek | Jul 2006 | A1 |
20060271063 | Sunada et al. | Nov 2006 | A1 |
20080039862 | Tran | Feb 2008 | A1 |
20080200922 | Brown | Aug 2008 | A1 |
20080221585 | Downer | Sep 2008 | A1 |
20080281333 | Pessing | Nov 2008 | A1 |
20110015644 | Pankin | Jan 2011 | A1 |
20120130390 | Davies | May 2012 | A1 |
20130165943 | Downer | Jun 2013 | A1 |
20140066946 | Aguilera et al. | Mar 2014 | A1 |
20140303636 | Valle | Oct 2014 | A1 |
20160250069 | Dockhom | Sep 2016 | A1 |
20180271647 | Mueller | Sep 2018 | A1 |
Number | Date | Country |
---|---|---|
1625834 | Feb 2006 | EP |
2 939 637 | Apr 2015 | EP |
2 868 295 | May 2015 | EP |
3 391 855 | Oct 2018 | EP |
05103803 | Apr 1993 | JP |
05103808 | Apr 1993 | JP |
05103809 | Apr 1993 | JP |
WO 2013038689 | Mar 2013 | WO |
WO-2015075489 | May 2015 | WO |
WO 2017104690 | Jun 2017 | WO |
Entry |
---|
https://www.thefreedictionary.com/groove, retrieved Aug. 7, 2019, definition of the term “groove” (Year: 2019). |
Number | Date | Country | |
---|---|---|---|
20180221142 A1 | Aug 2018 | US |