JP6502431B2 - Extra-thin tube needle for intrascleral fixation in intraocular lens - Google Patents

Description

  The present invention relates to a needle with a micro tube for intra-scleral intracapsular fixation used for placing an intraocular lens in the eye.

  It is widely practiced to implant an artificial intraocular lens instead of a lens whose function has been impaired by a cataract or the like. In normal cataract surgery, the lens in the eye is removed while leaving the lens capsule to support the lens, and the intraocular lens is inserted into the lens capsule.

  The intraocular lens used at this time is generally composed of a lens portion (optical portion) and a support portion for positioning and supporting the lens portion in the eye. The optical part is circular and has a diameter of about 5 to 7 mm, and an intraocular lens that can be folded is used to insert it from a small incision. The lens to be folded is called Foldable IOL, but initially it is made of silicone and then a material made of soft acrylic has been developed for the purpose of giving smaller functions and other various functions. . The optical part and the support part may be made of different materials or the same material. For example, there is an intraocular lens described in Non-Patent Document 1.

  Under such circumstances, the lens capsule may be strongly damaged during cataract surgery, and the intraocular lens may not be successfully inserted into the lens capsule. In this case, it is necessary to perform an operation for implanting the support portion of the intraocular lens into the sclera serving as the wall of the eye, and the intraocular lens scleral fixation. According to this intrascleral fixation, it is necessary to pull out the support part of the lens put in the eye out of the eye.

  In the conventional method, a hole is made in the eyeball, a forceps is inserted from the hole, and the support part is grasped and pulled out, as in Non-Patent Document 2, a sharp needle such as a needle having a lumen is pointed to the eyeball. There was a technique in which the support was inserted into the lumen and the support was pulled out with the sharp needle. However, in both methods, the support part needs to be captured in the eye, and only a skilled operator can perform the operation.

  Moreover, as a device widely used when the lens capsule is not damaged, for example, a device for loading an intraocular lens as described in Non-Patent Document 3 is known.

"Eternity" medical device approval number: 21900 BZ X 0094 7000 Revised (Fifth Edition), rear chamber lens JMDN code: 35658 100 [Manufacturer] Santen Pharmaceutical Co., Ltd. Sutureless 27-Gauge Needle-Guided Intrascleral Intraocular Lens Implantation With Lamellar Scleral Dissection, S Yamane, M Inoue, A Arakawa, and K Kadonosono, Ophthalmology 121 (1), 61-66. 2013 Oct 20. Attachment “Accut” Certification No .: 223AIBZX00014000 Revised on July 1, 2013 JMDN Code: 36061002 Single-use Intraocular Lens Inserter [Manufacturer] Santen Pharmaceutical Co., Ltd.

  The present invention provides a micro-tubed needle for intrascleral fixation of intraocular lenses.

  The ultrafine tubed needle for intraocular lens fixation according to the present invention comprises an ultrafine tube and a needle suitable for penetrating the eye. One end of the ultrafine tube and the needle are joined at the end of the needle. The inner diameter of the ultrafine tube is 0.1 to 0.4 mm, and the diameter of the needle is preferably 0.2 to 0.5 mm.

  The extra-thin tube can be made thicker at its middle part to correspond to the cross-sectional size of the support part of the intraocular lens. Moreover, the marking for cutting demonstrated below can be provided.

It is a top view of the extra-fine tube equipped needle concerning one embodiment of the present invention. It is a top view of the extra-fine tube equipped needle concerning another form of the present invention. It is a schematic diagram which shows the usage aspect example of the extra-fine tube equipped needle of this invention.

  FIG. 1 is a plan view of a needle with a micro tube for intrascleral fixation in accordance with an embodiment of the present invention. According to this embodiment, the ultrafine tube 2 is joined to the straight needle 1. As the extra fine tube 2, an extra fine tube made of commercially available silicone or synthetic resin such as silicone rubber can be used. As the extra fine tube 2, various materials can be used if the conditions such as the inner diameter and the outer diameter, the flexibility and the strength are met. Such extra fine tubes (also sold as "microtubes") are sold, for example, by As One Corporation. The inner diameter is 0.1 mm to 0.4 mm, and the outer diameter is preferably 0.2 mm to 0.5 mm corresponding to the inner diameter, but an appropriate inner diameter can be selected depending on the thickness of the support of the intraocular lens to be used. Generally, the inner diameter is 0.2 mm and the outer diameter is 0.3 mm. The length of this extra thin tube is at least 30 mm or more in consideration of the size of the cornea, and there is no particular upper limit. For example, 10 cm would be sufficient.

  In addition, various needles are used for ophthalmic surgery, and there are round needles having a round cross-sectional shape, triangular square needles, straight straight needles, curved needles, needles having a silicone surface-treated needle tip, etc. However, although any form of needle can be used, a straight needle having a round cross-sectional shape can be suitably used. The material is generally stainless steel and can be made by cutting a stainless steel bar. The diameter of the main body portion of the needle may be about 0.2 mm to 0.8 mm, preferably 0.2 mm to 0.5 mm. The length of the needle is generally 12 mm to 20 mm, preferably 14 mm to 18 mm. Bonding of the microtubes and the needle can be performed using conventional techniques used in the manufacture of needled sutures. That is, a minute hole is made along the axis of the needle at the end of the needle using a laser or the like, and after pressing the ultrafine tube there, pressure is applied to the end and the ultrafine tube is crimped to the crushed hole Let's do it. In FIG. 1, a straight needle with a diameter of 0.3 mm and a length of 1.5 cm is shown.

  Incidentally, as shown in FIG. 2, the extra-thin tube can be made thicker at its middle part, and the inner diameter of the middle part can be made to correspond to the cross-sectional size of the support part of the intraocular lens. Moreover, the marking for cutting can be given to the middle part. This can be provided by an ink that is compatible with silicone and is less likely to lose color. By doing so, it is possible to easily cut the ultrafine tube described below at an appropriate position.

  For example, as described in Non-Patent Document 1, in addition to an intraocular lens having a supporting portion of a material different from the optical portion, an intraocular lens in which the optical portion and the supporting portion are made of the same material is also widely used. ing. In such an intraocular lens, the support section is often shaped to be large in cross section. In order to cope with such an intraocular lens, as shown in FIG. 2, it is conceivable to increase the inner diameter of the middle portion of the extra-thin tube. For example, the inner diameter of the middle portion may be 0.2 mm to 0.6 mm. The end of the support can be folded and stored within this inner diameter. This makes it possible to easily insert and position an integrated intraocular lens in which the materials of the optical part and the support part are the same while minimizing the degree of invasiveness to the eye. Furthermore, by applying markings to the thickened middle part, the position to be cut can be surely recognized, and the ease and certainty of the operation can be further improved.

  Next, with reference to FIG. 3, the mode of use of the micro-tubed needle of the present invention will be described. First, as shown in FIG. 3 (a), the needle 1 is pierced from the side of the sclera of the eye and inserted to the center position in the eye. A 27-gauge needle (27 G: outer diameter 0.41 ± 0.02 mm, inner diameter) with a lumen from the position opposite to the sclera as a guide for withdrawing the ultrathin tubed tube inserted into the eye from the sclera opposite side of the insertion part Pour an injection needle like 0.22 ± 0.03 mm). The 27-gauge needle and the ultra-thin tube needle 1 are docked in the eye. Then, when the 27-gauge needle is withdrawn together with the extra-fine tubed needle, only the extra-fine tube 2 remains in the eye. FIG. 3 (a) shows a 27-gauge needle withdrawn from the eye. Then, the extra thin tube in the eye is pulled out from the direction perpendicular to the penetration direction. This can be easily done by hooking a micro tube using a micro forceps or a lens hook or the like for adjusting the lens position in the eye. This operation can be performed by any operator who can perform normal cataract surgery. A state where this extra thin tube is pulled out of the eye is shown in FIG. 3 (b). If the extra-fine tube is pulled out of the eye, it may be cut at an appropriate position and the end of the support of the intraocular lens inserted inside the cut end of the extra-fine tube to bond the extra-fine tube to the support it can. This operation will be performed outside the eye for both of the pair of supports. The significance of being able to join outside this eye is significant, and surgery can be performed with a level of invasiveness that is incomparably lower than the degree of invasiveness when trying to secure the end of the support in an exploratory manner in the eye . Unlike (a), in (b), the pupil is outlined so that the micro tube can be easily understood.

  After the bonding, the intraocular lens can be gently inserted into the eye, and only the intraocular lens support can be pulled out of the eye by pulling the opposite side of the site where the intraocular lens support is bonded. Finally, an incisional wound is made in the sclera in a pocket shape, and the intraocular lens can be fixed at a predetermined position in the eye by embedding the withdrawn support portion of the intraocular lens in the scleral pocket.

  In this way, operations performed in the eye can be minimized, physical damage to the eye can be minimized, and procedures independent of the operator's skill can be performed. The ultrafine-tubed needle of the present invention enables an innovative procedure that is less invasive than the techniques used to date.

Claims (2)

A needle with an ultrafine tube for intraocular dural fixation, comprising an ultrafine tube and a needle , wherein one end of the ultrafine tube and the needle are joined at the end of the needle ,
A needle with a microtube for intraocular fixation, for use in intracapsular entrapment, wherein the inner diameter of the microtube is increased at a certain distance from the needle, and a mark indicating the position to be cut is present near the center of the inner diameter extension.   The inner diameter of the ultrafine tube is 0.1 to 0.4 mm and the diameter of the needle is 0.2 to 0.5 mm. The needle with the ultrafine tube for intraocular fixation of the intraocular lens according to claim 1.

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