Source: http://patents.com/us-9808340.html
Timestamp: 2019-01-20 06:51:11
Document Index: 477380536

Matched Legal Cases: ['Application No. 12760887', 'Application No. 2012232611', 'Application No. 2013147408', 'Application No. 12760887', 'Application No. 2013', 'Application No. 2012232611', 'Application No. 16205428']

US Patent # 9,808,340. Intraocular lens and manufacturing method thereof - Patents.com
United States Patent 9,808,340
Suzaki November 7, 2017
Provided is an intraocular lens having a novel structure with high utility which is easy to adapt to patients, and can improve quality of vision (QOV). In an intraocular lens, an optical characteristic is set rotationally symmetric around an optical axis, and a spherical aberration of a size corresponding to a coma aberration remaining in a patient's eye after extraction of a human lens of the eye is set.
Suzaki; Asaki (Kasugai, JP)
Suzaki; Asaki
KOWA COMPANY, LTD. (Nagoya, JP)
Family ID: 1000002932778
14/002,831
PCT/JP2012/002054
WO2012/127881
US 20140039616 A1 Feb 6, 2014
Mar 24, 2011 [JP] 2011-065836
Current CPC Class: A61F 2/1637 (20130101); G02C 7/027 (20130101); A61F 2240/001 (20130101); A61F 2/1613 (20130101)
Current International Class: A61F 2/16 (20060101); G02C 7/02 (20060101)
6905209 June 2005 Mihashi et al.
7078665 July 2006 Topa
2007/0121064 May 2007 Norrby et al.
2011/0102737 May 2011 Payor
A-2006-517676 Jul 2006 JP
A-2010-29694 Feb 2010 JP
B2-4459501 Apr 2010 JP
B2-4652558 Mar 2011 JP
01/89424 Nov 2001 WO
2006/088440 Aug 2006 WO
WO 2008/089999 Jul 2008 WO
2009/100322 Aug 2009 WO
2011/025846 Mar 2011 WO
Sep. 24, 2013 International Preliminary Report on Patentability issued in International Application No. PCT/JP2012/002054. cited by applicant .
Oct. 24, 2014 Extended Search Report issued in European Patent Application No. 12760887.5. cited by applicant .
Aug. 28, 2015 Patent Examination Report No. 1 issued in Australian Patent Application No. 2012232611. cited by applicant .
Jan. 29, 2016 Office Action issued in Russian Patent Application No. 2013147408/14. cited by applicant .
Oct. 29, 2015 Office Action issued in European Patent Application No. 12760887.5. cited by applicant .
Jan. 13, 2016 Office Action issued in Japanese Patent Application No. 2013-505827. cited by applicant .
Feb. 16, 2016 Office Action issued in Australian Patent Application No. 2012232611. cited by applicant .
Feb. 9, 2017 European Search Report issued in European Patent Application No. 16205428.2. cited by applicant .
Jun. 19, 2012 International Search Report issued in International Patent Application No. PCT/JP2012/002054. cited by applicant.
1. An intraocular lens manufacturing method comprising: an optical characteristics setting step of setting in an optical portion a spherical aberration of an amount for which a spherical aberration and a coma aberration remaining in a human eye of a patient from which a human lens was extracted will not be offset; a lens shape setting step of determining a lens shape of the optical portion wherein the spherical aberration set at the optical characteristics setting step is provided as a corrective optical characteristic for a residual irregular astigmatism in that human eye of that patient; and a lens forming step of forming an intraocular lens having optical characteristics in which a high-order aberration of that optical portion is rotationally symmetrical around an optical axis, by means of forming the optical portion to have the lens shape determined by the lens shape setting step, wherein the coma aberration is a value selected from the group consisting of: (i) an RMS value; (ii) a value found based on cornea topography measurement values obtained using a keratometer, a reflex keratometer, or a wave surface sensor; and (iii) a value expressed as a synthetic vector volume of a horizontal coma aberration and a vertical coma aberration which are C.sub.3.sup.1 and C.sub.3.sup.-1 terms with Zernike polynomials obtained by performing wave aberration analysis, and in the optical characteristics setting step, the spherical aberration of the optical portion is set with an RMS value that satisfies both of the following formulas: Intraocular lens spherical aberration.gtoreq.Coma aberration remaining in the eye after lens extraction-0.37 .mu.m; and Intraocular lens spherical aberration.ltoreq.Coma aberration remaining in the eye after lens extraction-0.17 .mu.m.
2. An intraocular lens comprising: an optical portion being set with a spherical aberration as a corrective optical characteristic for a residual irregular astigmatism in a human eye of a patient, the spherical aberration being of an amount for which a spherical aberration and a coma aberration remaining in the human eye of the patient from which a human lens was extracted is not offset, wherein a high-order aberration of the optical portion is rotationally symmetrical around an optical axis, and the coma aberration is a value selected from the group consisting of: (i) an RMS value; (ii) a value found based on cornea topography measurement values obtained using a keratometer, a reflex keratometer, or a wave surface sensor; and (iii) a value expressed as a synthetic vector volume of a horizontal coma aberration and a vertical coma aberration which are C.sub.3.sup.1 and C.sub.3.sup.-1 terms with Zernike polynomials obtained by performing wave aberration analysis, and the spherical aberration set for the optical portion has an RMS value that satisfies both of the following formulas: Intraocular lens spherical aberration.gtoreq.Coma aberration remaining in the eye after lens extraction-0.37 .mu.m; and Intraocular lens spherical aberration.ltoreq.Coma aberration remaining in the eye after lens extraction-0.17 .mu.m.
Patent Document 1: JP-B-4459501 Patent Document 2: JP-A-2006-517676
For this kind of determination method, a device that can easily measure the spherical aberration for not only the lens optical system but also the human eye optical system is disclosed in Japanese Patent No. 4652558, the specification of U.S. Pat. No. 7,078,665 and the like, and for example since the OPAL 300 (product name) made by Spot Optics Corp. is available on the market as a wave aberration measurement device using the Shack-Hartmann Method, a person skilled in the art could implement this easily. In particular, when determining the value of the spherical aberration corresponding to the coma aberration with the eye optical system, it is not necessary to match both items, as described above. For example, even when dealing with contact lenses or glasses, prescription is ultimately left to the subjective vision sense of the user, or is selected based on consideration of the application. From this point of view, determination of the value of the spherical aberration should be handled by the person skilled in the art by referencing the user's opinion, the eye optical system objective measurement information or the like. Thus, compared to the prior art structure contact lenses as noted in Patent Documents 1 and 2, for example, implementing the present invention does not involve an impractical level of difficulty. Of course, with the present invention, to make it possible to more easily and quickly determine the spherical aberration, it is effective to further narrow the selection range of the spherical aberration, and from that objective, it is preferable to use the optical characteristics selection technology given by the formulas and the like noted hereafter.
Specifically, with the human eye, even in a state with the human lens extracted, there are cases when there is spherical aberration due to the shape of the cornea and the like, for example. In that case, the spherical aberration set for the intraocular lens of the present invention is designed considering the spherical aberration remaining in the human eye with the human lens extracted. In specific terms, at the optical characteristics setting step, the spherical aberration of the optical portion with the intraocular lens (RMS value) is preferably set with an RMS value that satisfies any of the following formulas in relation to the coma aberration remaining in the eye after the human lens is extracted (RMS value). Intraocular lens spherical aberration.gtoreq.Coma aberration remaining in the eye after lens extraction-0.37 .mu.m Intraocular lens spherical aberration.ltoreq.Coma aberration remaining in the eye after lens extraction-0.17 .mu.m
The RMS value is the value (unit: .mu.m) for which the wave aberration in the pupil area of the human eye optical system is put into numerical form (displayed as root mean square) using a wave aberration analysis device (wave sensor). According to the formulas noted above, by giving spherical aberration corresponding to the coma aberration of the patient eye to the intraocular lens, it is easy to obtain good QOV that also considers the spherical aberration remaining in the cornea.
Also, the optical characteristics of the human eye tend to change as age increases. In light of that, using the optical characteristics of the cornea or the like, for example, it is possible to estimate the coma aberration remaining in the patient after the human lens is extracted according to the age of the patient. From this perspective, as a result of additional examination by the inventor of the present invention, with the optical characteristics setting step, setting the spherical aberration set for the optical portion in the intraocular lens (RMS value) using the patient age corresponding to the coma aberration as an index based on the following formulas is also effective for obtaining good QOV. Intraocular lens spherical aberration=A+B.times.Patient age -0.4.ltoreq.A(.mu.m).ltoreq.-0.1 0.003.ltoreq.B(.mu.m).ltoreq.0.004
Furthermore, considering the fact that coma aberration, which is one human eye optical characteristic, changes according to age, additional examination was made by the inventor of the present invention. As a result, it was found that from human eye optical characteristics measurement data for the population of the same age bracket as the patient for which the human lens has been extracted, it is possible to find an intraocular lens spherical aberration that will give good QOV to that patient. Specifically, with the optical characteristics setting step, using an intraocular lens for which the spherical aberration for the optical portion is set using the difference between the average value of the measurement data of the human eye spherical aberration for the same age bracket population as the patient and the spherical aberration of the cornea of that patient is effective for obtaining good QOV.
As is well known, the value of the spherical lens power (D) is determined based on the ocular axis length and corneal shape of the patient, and typically a value of approximately +10 to 25 D is set. In most cases, the spherical lens power is set as a single focal point, but it is also acceptable to have multiple focal points set.
Meanwhile, the spherical aberration for the optical portion 12 of the intraocular lens 10 is set at a size corresponding to the value of the coma aberration remaining in the human eye 16 of the patient for which the human lens was extracted, and of a size such that the spherical aberration will not be offset and will be made to remain in the human eye 16 of the patient. In specific terms, with the human eye 16 of the patient for which the intraocular lens has been inserted, the spherical aberration is set for the optical portion 12 of the intraocular lens so that the size of the coma aberration is roughly the same level as the spherical aberration. In this way, the manufacturing method of the intraocular lens 10 with this embodiment is constituted including the optical characteristics setting step. The coma aberration and the spherical aberration values can both be represented by RMS values (.mu.m). In other words, the volume of skew in the light ray direction by the actual wave surface in relation to the virtual wave surface orthogonal to the light rays expresses each aberration as a value expressed in root mean square on that virtual wave surface. Also, the coma aberration existing in the human eye 16 of the patient in which the intraocular lens 10 is inserted is almost all according to the cornea with the present invention using the intraocular lens 10 having optical characteristics rotationally symmetrical around the optical axis. The coma aberration of the cornea of the patient can be found based on cornea topography measurement values obtained using, for example, a keratometer, a reflex keratometer, or a wave surface sensor. For example, the C.sub.3.sup.1 and C.sub.3.sup.-1 terms are the horizontal coma aberration and vertical coma aberration with Zernike polynomials obtained by performing wave aberration analysis, for example, and the coma aberration is expressed as a synthetic vector volume of the horizontal coma aberration and the vertical coma aberration.
At that time, spherical aberration by an ocular tissue other than the intraocular lens 10 exists in the human eye 16 in which the intraocular lens has been inserted. Almost all the spherical aberration remaining in the human eye 16 after the human lens is extracted is due to the cornea. Because of that, the spherical aberration of the intraocular lens 10 itself is determined considering the spherical aberration of the cornea of the patient. The spherical aberration of the cornea of the patient can be found based on measurement values by the same kind of measurement devices as the coma aberration noted above. For example, the C.sub.4.sup.0 term with a Zernike polynomial obtained by performing wave aberration analysis is used as the spherical aberration. Therefore, the spherical aberration value set for the intraocular lens 10 can be found based on the formula below. Intraocular lens spherical aberration.apprxeq."Coma aberration remaining in the eye after lens extraction"-"Cornea spherical aberration"
However, with the formula above, "Intraocular lens spherical aberration" is not necessarily optimally perfectly matched to the right side of the equation ("coma aberration remaining in the eye after lens extraction"-"cornea spherical aberration"). Perhaps this is because the vision (QOV) is a subjective item and there is a big individual difference, and for example the intraocular lens spherical aberration judged to be optimum may be different between a patient who senses that having a big difference in sharpness due to a difference in the distance from the subject item is not desirable, and a patient who thinks he'd like to observe only objects of a specified distance at the highest level of sharpness.
Also, as shown in FIG. 3, the corneal spherical aberration of the human eye 16 almost doesn't change at all with aging, and it is possible to estimate the average spherical aberration across all ages to be 0.27 .mu.m (RMS). Considering this fact, it is possible to use the following formulas to express the preferable setting range of the spherical aberration (RMS value) for the optical portion 12 of the intraocular lens 10 set with the optical characteristics setting process described previously. Intraocular lens spherical aberration.gtoreq.Coma aberration remaining in the eye after lens extraction-0.37 .mu.m Intraocular lens spherical aberration.ltoreq.Coma aberration remaining in the eye after lens extraction-0.17 .mu.m
Furthermore, the coma aberration remaining in the eye after lens extraction is almost all due to the cornea, and as shown in FIG. 4, that cornea coma aberration changes as a linear function according to aging in a range of roughly 0.2 to 0.3 .mu.m. Considering this fact, the preferable setting range of the spherical aberration (RMS value) with the optical portion 12 of the intraocular lens 10 set during the optical characteristics setting process described previously can be expressed using the following formulas for which A and B are each constants. Intraocular lens spherical aberration=A+B.times.Patient age -0.4.ltoreq.A(.mu.m).ltoreq.-0.1 0.003.ltoreq.B(.mu.m).ltoreq.0.004
First, FIG. 5 shows the simulation results when the intraocular lens manufactured according to the present invention was used for a 60 year old patient. With this simulation, using optical design software ZEMAX (product name, made by Zemax Development Corp. of the U.S.), as an eyeball model of a 60 year old patient, an item with coma aberration (vertical coma aberration volume of the C.sub.3.sup.-1 term with a Zernike polynomial) of 0.24 .mu.m was constructed, and optical characteristics of the eye optical system correlating to the optical area applicable to a pupil of 6 mm were evaluated with a Landolt ring simulation optical image. Specifically, examples 1 through 5 and comparative example 1 all correlate to a human eye in which the intraocular lens is inserted, and are thought to be items for which coma aberration of 0.24 .mu.m remains. Then, for each model of these examples 1 through 5 and comparative example 1, with the point for which the focal point position by spherical lens power is optimum (0.00 D) as a reference, a simulation optical image of each position when the focal point position is skewed in the near direction by a distance correlating to 0.50 D and 1.00 D from there was obtained, and the vision (QOV) was assessed using those.
For that human eye, with comparative example 1, according to the technical concept as noted in Patent Document 1, for example, this correlates to a case when the intraocular lens was inserted so as to have the spherical aberration (spherical aberration volume of the C.sub.4.sup.0 term with a Zernike polynomial) become zero (namely, for which spherical aberration of the reverse code was set so as to offset the spherical aberration remaining in the cornea). Meanwhile, with examples 1 through 5, in all cases, this correlates to a case when the intraocular lens was inserted with optical characteristics for which spherical aberration was set actively according to the present invention. In particular, the example 3 correlates to a case when the spherical aberration of the intraocular lens was set considering the spherical aberration of the cornea so that spherical aberration of the same RMS value as the coma aberration remaining in the human eye is set.
Also, FIG. 6 shows the simulation results when using an intraocular lens manufactured according to the present invention for a 20 year old patient. With this simulation, the same as with examples 1 through 5 noted above, using ZEMAX, as the eyeball model of a 20 year old patient, an item of coma aberration (vertical coma aberration volume of the C.sub.3.sup.-1 term with the Zernike polynomial) of 0.14 .mu.m was constructed, and for optical characteristics of the eye optical system correlating to the optical area corresponding to a pupil of 6 mm, a Landolt ring simulation optical image was obtained and vision was assessed.
10: Intraocular lens 12: Optical portion 16: Human eye
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