WO2007097221A1 - outil d'insertion de cristallin artificiel - Google Patents
outil d'insertion de cristallin artificiel Download PDFInfo
- Publication number
- WO2007097221A1 WO2007097221A1 PCT/JP2007/052460 JP2007052460W WO2007097221A1 WO 2007097221 A1 WO2007097221 A1 WO 2007097221A1 JP 2007052460 W JP2007052460 W JP 2007052460W WO 2007097221 A1 WO2007097221 A1 WO 2007097221A1
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- WO
- WIPO (PCT)
- Prior art keywords
- plunger
- intraocular lens
- lens
- main body
- insertion device
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
- A61F2/1662—Instruments for inserting intraocular lenses into the eye
Definitions
- Intraocular lens insertion device Intraocular lens insertion device
- the present invention relates to an intraocular lens insertion device for inserting an intraocular lens into an eyeball instead of a crystalline lens removed by cataract surgery.
- the implanted intraocular lens has a hard intraocular lens whose optical part is made of a hard material such as polymethylmethallate (PMMA), and a soft material that is made of a soft material such as silicone elastomer, soft acrylic, and hyde mouth gel.
- PMMA polymethylmethallate
- a soft material that is made of a soft material such as silicone elastomer, soft acrylic, and hyde mouth gel.
- intraocular lens When using a rigid intraocular lens, it is necessary to insert the intraocular lens into the cornea or sclera through an incision with a width approximately the same as or slightly larger than the diameter of the optical part.
- the intraocular lens when a soft intraocular lens is used, the intraocular lens can be inserted into the eyeball from a smaller incision by folding the optical part. By performing surgery with a small incision, the risk of corneal astigmatism after surgery can be avoided. Powerful circumstances In recent years, soft intraocular lenses have been favored.
- a method for inserting a soft intraocular lens into an eye is called an injector, in addition to a method for directly inserting an intraocular lens (hereinafter simply referred to as a lens) folded by an insulator directly into the eye.
- a dedicated intraocular lens insertion device In general, the basic structure of an injector consists of a nozzle portion that is tapered to insert the lens into the eye, a plunger that pushes out the lens, and a cylindrical body that holds them.
- Various types of intraocular lens insertion devices have been proposed. They are roughly classified into two-handed and one-handed.
- a double-handed intraocular lens insertion instrument is one in which an intraocular lens is inserted into an eyeball by holding a body of the insertion instrument with one hand and pushing a plunger with the other hand.
- a female screw and a screw provided in a part of the main body at the rear end of the plunger.
- a matching male screw is provided, and the rear end of the plunger is rotated to move the plunger back and forth to push out the lens.
- the one-hand operated intraocular lens insertion instrument is configured such that the index finger and the middle finger of one hand are brought into contact with a gripping piece provided in the insertion instrument body, and the thumb is brought into contact with the end face of the plunger and pressed.
- the lens is inserted into the eyeball.
- One-hand operated intraocular lens insertion instruments can be operated with only one hand, and have the advantages of using the other hand to grasp and stabilize eye tissue with tweezers, or to operate other surgical instruments.
- By using such a dedicated indicator it is possible to fold the lens smaller than using a lever, and an incisional loci of 3 mm or less can be inserted into the eye.
- a one-hand operated intraocular lens insertion device presses a lens with a plunger housed in a cylindrical body so as to be reciprocally movable, and releases it into the eye.
- the pressing force varies greatly depending on the sliding resistance between the lens and the inner surface of the main body.
- the sliding resistance between the lens and the inner surface of the main body is large, and it becomes difficult to control the pushing force when the folded lens is released at the tip of the main body, which is a nozzle. Risk damaging the intraocular tissue. Therefore, an injector having a structure that can gently push the plunger in any situation has been desired.
- a rubber O-ring is disposed between the outer peripheral surface of the plunger and the inner peripheral surface of the main body, and a certain pressing force is applied to the side surface of the plunger to reduce the sliding resistance.
- Technology to change is disclosed.
- the O-ring is arranged in this way, the number of parts increases, so that the manufacturing cost becomes expensive.
- the size of the sliding resistance varies depending on the individual due to the manufacturing dimension error of the O-ring body (see, for example, Patent Document 1).
- a panel is interposed between the main body and the plunger so that a load in the opposite direction is applied to the plunger. Have been disclosed. (For example, see Patent Document 2).
- Patent Document 1 Japanese Unexamined Patent Application Publication No. 2004-113610
- Patent Document 2 Japanese Translation of Special Publication 2000-516487
- the present invention is intended to solve such a problem of the conventional technology, and can insert the lens into the eyeball safely and securely by pushing the plunger gently with only one hand operation. It is an object to provide an instrument.
- the invention according to claim 1 includes a cylindrical main body that passes through a deformable intraocular lens and guides it into the eyeball, and is reciprocally moved in the main body.
- the eyeball is pressed by pressing the intraocular lens.
- An intraocular lens insertion device comprising a plunger that is released into the body, and an elastic body and Z or a sliding resistance increasing mechanism between the main body and the plunger, and the pressing force (F) force of the plunger In the movement stroke (X) of the plunger after reaching the first peak value, 60% or more of the peak value can be maintained.
- the invention according to claim 2 includes a cylindrical main body that passes through a deformable intraocular lens and guides it into the eyeball, and is reciprocally moved in the main body, and presses the intraocular lens to press the eyeball.
- a plunger that releases into the body, and an elastic body and Z or between the main body and the plunger.
- An intraocular lens insertion device provided with a sliding resistance increasing mechanism, wherein the value of the plunger pressing force (F) with respect to the movement stroke (X) of the plunger does not decrease It is.
- the invention according to claim 3 is the intraocular lens insertion device according to claim 1 or 2, characterized in that the elastic body includes a plurality of elastic bodies having different elasticity values. is there
- the invention according to claim 4 is the intraocular lens insertion device according to claim 1 or 2, characterized in that the elastic value of the elastic body has a nonlinear characteristic.
- the intraocular lens insertion device of claim 1 since the pressing force of the plunger with respect to the movement stroke of the plunger does not significantly decrease even after the first peak has elapsed, Can also move the plunger gently. Therefore, the lens can be safely and reliably inserted into the eyeball.
- the plunger can be loosened even with one-handed operation. Can be moved. Therefore, the lens can be inserted into the eyeball safely and reliably.
- the panel reaction force with respect to the movement stroke of the plunger can be made to have a discontinuous characteristic by combining a plurality of elastic bodies having different elastic values. As a result, the maximum value of the plunger pressing force can be suppressed.
- the panel reaction force with respect to the movement stroke of the plunger can be designed more precisely.
- FIG. 1 is a cross-sectional view of an intraocular lens insertion device showing a first embodiment of the present invention.
- FIG. 2 is a characteristic diagram showing the relationship between the plunger stroke and the pressing force of an intraocular lens insertion device without an elastic body.
- FIG. 3 is a characteristic diagram showing the relationship between the plunger travel and the pressing force when a lens is not loaded into an intraocular lens insertion device provided with an elastic body.
- FIG. 4 is a characteristic diagram showing the relationship between the plunger travel and the pressing force in the intraocular lens insertion device of the first embodiment.
- FIG. 5 is a characteristic diagram showing the relationship between the plunger travel and the pressing force when elastic bodies having different elasticity values are used.
- FIG. 8 is a cross-sectional view of an intraocular lens insertion device showing a second embodiment of the present invention.
- FIG. 9 is a characteristic diagram showing the relationship between the travel of the plunger and the pressing force when the intraocular lens insertion device of the second embodiment is not loaded with a lens.
- FIG. 10 is a cross-sectional view of an intraocular lens insertion device showing a third embodiment of the present invention.
- FIG. 11 is a cross-sectional view of an intraocular lens insertion device showing a fourth embodiment of the present invention.
- FIG. 1 is a sectional view showing a first embodiment of an intraocular lens insertion device to which the present invention is applied.
- the intraocular lens insertion device 1 is housed in a cylindrical main body 3 that passes through a deformable intraocular lens 2 and is guided into the eyeball, and is reciprocally moved in the main body 3, and presses the intraocular lens 2.
- a plunger 4 that is released into the eyeball, and an elastic body 5 between the main body 3 and the plunger 4.
- the cylindrical main body 3 includes a nozzle 3a in which the tip of the incisional locus of the eyeball is inserted into the eyeball, a lens installation portion 3b in which the lens 2 is installed, and a gripping portion 3c in which the operator's finger holds the finger. Is provided. Further, the lens installation portion 3b is provided with a lid 6 that can be freely opened and closed, and the lens installation portion 3b is provided with a fixing projection 3d for restricting the movement of the lens 2.
- the main body 3 is provided with an intermediate support portion 3e that pivotally supports the plunger 4, and a base end support member 7 that pivotally supports the plunger 4 is also provided on the base end side of the main body 3. In FIG.
- the main body 3 and the base end support member 7 are configured as separate members, but both members have good lubrication characteristics and low frictional resistance. It is also possible to configure.
- the main unit 3 It is possible to manufacture the nozzle 3a and the gripping part 3c separately, and then assemble them together by assembling.
- the material of the constituent members of the device is required to be a physically stable material.
- the materials used at the site of insertion into the eye must be biologically safe.
- FDA Food and Drug Administration
- ISO International Standardization Organization
- the material is confirmed.
- polyethylene, polypropylene, or the like can be used as the material of the cylindrical main body 3.
- the lens 2 also has a force with an optical part 2a which is a lens body and two support members 2b for fixing the position of the optical part 2a in the eyeball.
- the support member 2b has a thin beard shape.
- This lens 2 is made of a flexible material such as soft acrylic and can fold the lens itself.
- the plunger 4 includes a portion 4a having an outer diameter that is slightly smaller than the inner diameter of the proximal support member 7, and a portion 4b having an outer diameter that is slightly smaller than the inner diameter of the nozzle.
- a portion 4 a having an outer diameter slightly smaller than the inner diameter of the base end support member 7 is slidably inserted into the base end support member 7.
- a portion 4b having an outer diameter slightly smaller than the inner diameter of the nozzle 3a is slidably inserted into the intermediate support portion 3e of the main body.
- a panel 5 as an elastic body is attached between the main body 3 and the plunger 4.
- a string spring 5 is mounted between the right end surface of the intermediate support portion 3e of the main body and the step portion 4c of the plunger.
- This string spring 5 must have an appropriate panel constant and an appropriate deformation amount! /, which will be described later.
- the operator can insert the lens 2 into the eyeball with a single hand operation. Specifically, the grasping portion 3c of the main body is grasped by the index finger and middle finger of one hand, and the abdomen of the thumb is brought into contact with the base end 4d of the plunger and the plunger 4 is pushed into the main body 3. Then lens 2 is plunge It is pressed by the tip of the nozzle 4 and is pushed into the nozzle 3a while being folded at the tapered lens transition portion 3f. When the plunger 4 is further pushed in, the lens 2 moves in the nozzle 3a and is released into the eyeball from the opening 3g at the tip of the nozzle.
- the movement stroke (X) itself of this plunger is the movement stroke (X) itself of this plunger.
- the horizontal axis travels from the right side to the left side.
- the point where the horizontal axis intersects the vertical axis indicates the position after the lens 2 that is not at the origin is released.
- FIG. 2 is a characteristic diagram in which the relationship between the movement stroke (X) and the pressing force (F) of the plunger 4 of the intraocular lens insertion device 1 without the elastic body 5 is measured.
- This characteristic has been measured for many actual objects, and it has been found that although there are some individual differences, it shows an almost constant relationship. Even if the same intraocular lens insertion device is used, the characteristics will be different because the lens thickness will be different if the power of the intraocular lens is different. As a matter of course, the peak value of the pressing force becomes large in the case of a thick lens having a high frequency.
- the point (i) on the horizontal axis corresponds to the point (i) in FIG. 1, that is, the tip position of the nozzle 3a.
- the (mouth) point on the horizontal axis corresponds to the (mouth) point in FIG. 1, that is, the boundary position between the lens transition portion 3f and the nozzle 3a.
- the speed at which the plunger 4 is pushed may be a speed suitable for inserting the lens 2 into the eye, and generally a force of about 70 mm / min to about 20 mm / min to 200 mm / min. 130 mm / min is preferred.
- the force required to fold the lens becomes maximum.
- the plunger pressing force (F) reaches its peak. Thereafter, when the plunger 4 is further pressed and the lens 2 is moved to the left side, the pressing force (F) required for the plunger is rapidly reduced.
- the reason why the pressing force (F) required to move the lens 2 in the substantially cylindrical nozzle 3a suddenly decreases is that the force required to fold the lens 2 becomes unnecessary and the nozzle opening 3g is folded. This is based on enlargement by receiving the internal pressure from the lens.
- FIG. 3 is a characteristic diagram showing the relationship between the travel stroke (X) of the brassiere 4 and the pressing force (F) when the lens 2 is not loaded into the intraocular lens insertion device 1 provided with the elastic body 5. is there.
- the significance of the vertical and horizontal axes is the same as in Fig. 2 (hereinafter also the same in Figs. 3 to 7 and 9).
- O The point (c) on the horizontal axis moves the plunger 4
- the position where the panel 5 starts to be compressed by the step 4c is shown. Since the string spring 5 having linear characteristics is used as an elastic body, the plunger pressing force (F) increases linearly after the panel starts to deform.
- FIG. 4 is a characteristic diagram showing the relationship between the movement stroke (X) of the plunger 4 and the pressing force (F) when the lens 2 is loaded into the intraocular lens insertion device 1 of the first embodiment and pushed out. It is. This is the case where the panel constant and the panel deformation amount are set appropriately. As a result, the characteristics shown in Fig. 2 and Fig. 3 are superimposed. In other words, when the plunger 4 is moved from the right side to the left side, the plunger pressing force (F) starts to rise when the plunger travel (X) reaches the panel deformation start position (c).
- the pressing force (F) of the plunger is such that the lens 2 contacts the nozzle inner wall force nozzle of the lens transition part 3f. It increases continuously until it reaches the field position (mouth) point.
- the plunger pressing force (F) increases again without significantly decreasing although it slightly decreases from the peak value at the (mouth) point.
- the plunger pressing force (F) does not decrease. Therefore, even if the nozzle 3a force is also at the position (ii) where the lens 2 is released, the plunger pressing force (F) suddenly disappears, and there is no danger of the tip of the plunger surging and jumping into the eyeball. .
- FIG. 5 is a characteristic diagram showing the relationship between the plunger travel (X) and the pressing force (F) when an elastic body having an elastic value different from that of the injector of the first embodiment is used. is there.
- This elastic body has an excessive panel reaction force against the force required to deform the lens, and has the advantage that the pressing force (F) of the plunger increases almost linearly.
- the plunger pressing force (F) at the point (i) where the lens is released from the tip of the nozzle becomes too large.
- FIG. 6 is a characteristic diagram showing the relationship between the plunger travel (X) and the pressing force (F) when an elastic body having an elastic value different from that of the elastic body shown in FIG. 5 is used.
- This elastic body has a panel reaction force that is approximately appropriate for the force required to deform the lens.
- the plunger pressing force (F) is discontinuous, the plunger travel (X The plunger's pressing force (F) against) does not decrease.
- FIG. 7 further shows the relationship between the plunger travel (X) and the pressing force (F) when an elastic body having an elastic value different from that shown in FIGS. 5 and 6 is used.
- This elastic body has an excessive panel reaction force against the force required to deform the lens, and the tip force of the nozzle
- the plunger's pressing force (F) at the point (i) where the lens is released is large. There is an advantage that it does not become too much.
- the rate of decrease in the plunger pressing force (F) after the (mouth) point has passed is too large with respect to the initial peak value.
- the plunger pressing force (F) with respect to the movement stroke (X) of the plunger 4 is greatly increased even after the first peak has elapsed. Since it does not decrease, the plunger can be moved gently even with one-handed operation. Also, the plunger pressure against the plunger travel (X) Since the value of (F) does not decrease, the plunger can be moved gently even with one-handed operation. Therefore, the lens can be safely and reliably inserted into the eyeball.
- the plunger travel (X) after the plunger pressing force (F) reaches the first peak value should hold 60% or more of the peak value. This is defined based on the value that can be operated without the operator feeling uncomfortable when actually operating with one hand. Although this value varies slightly between individuals, considering safety, 75% or more is preferable, and 90% or more is even more preferable.
- FIG. 8 is a cross-sectional view of an intraocular lens insertion device showing a second embodiment of the present invention.
- This intraocular lens insertion device 1 is characterized by comprising a plurality of elastic bodies 5a and 5b having different elasticity values. Since the basic configuration is the same as that of the first embodiment shown in FIG. 1, the description of the common portions is omitted, and only the portion having a configuration different from that of the first embodiment will be described.
- one elastic body 5 is disposed between the main body 3 and the plunger 4, but in this embodiment, two panel 5a and 5b having different panel constants and deformation amounts are disposed. Yes.
- the deformation amount of the string hook spring 5a disposed on the inner side is set large, and the deformation amount of the string hook spring 5b disposed on the outer side is set small.
- a sliding ring 8 is slidably mounted on the plunger 4b between the right end of the string paddle panel 5a disposed on the inside and the step 4c of the plunger.
- FIG. 9 is a characteristic diagram showing the relationship between the plunger movement stroke (X) and the pressing force (F) when the lens 2 is not loaded in the intraocular lens insertion device of the second embodiment. is there.
- the pressing force (F) is small because only the sliding resistance between the plunger 4 and the main body 3 on which the plunger is supported is initially.
- the movement of the plunger 4 advances, and the string spring 5a disposed inside by the plunger step 4c starts to be compressed through the sliding ring 8.
- the panel reaction force with respect to the movement stroke (X) of the plunger can be made discontinuous by combining the panels 5a and 5b having a plurality of panel constants.
- an intraocular lens insertion device capable of suppressing the maximum value of the plunger's pressing force (F) can be realized.
- FIG. 10 is a cross-sectional view of an intraocular lens insertion device showing a third embodiment of the present invention.
- This intraocular lens insertion device 1 is characterized in that the elastic value of the elastic body has a nonlinear characteristic. Descriptions of portions common to the first and second embodiments shown in FIG. 1 are omitted, and only portions having configurations different from those of the embodiments are described.
- the elastic body 5 is disposed in the cylindrical main body 3, but in this embodiment, the elastic bodies 5c to 513 ⁇ 4 are provided between the main body 3 and the base end 4d of the plunger. It is arranged.
- FIG. 10 is a cross-sectional view of an intraocular lens insertion device showing a third embodiment of the present invention.
- This intraocular lens insertion device 1 is characterized in that the elastic value of the elastic body has a nonlinear characteristic. Descriptions of portions common to the first and second embodiments shown in FIG. 1 are omitted, and only portions having configurations different from those of the embodiments are described.
- FIG. 10 (a) shows two string springs 5c and 5d having different elastic values are arranged between the main body 3 and the base end 4d of the plunger.
- FIG. 10 (b) shows a string spring 5e in which the wire diameter gradually changes from one end to the other end between the main body 3 and the base end 4d of the plunger.
- FIG. 10 (c) shows a string hook spring 5 in which the string hook diameter gradually changes from one end to the other end between the main body 3 and the base end 4d of the plunger.
- a sliding ring 8 is attached to one end or both ends of each of the string springs 5c to 5f in order to ensure good seating when the panel is compressed.
- FIG. 11 is a cross-sectional view of an intraocular lens insertion device showing a fourth embodiment of the present invention.
- This intraocular lens insertion device 1 has an elastic body 5 disposed between a main body 3 and a plunger 4, and a sliding resistance increasing mechanism 9 is provided on an outer surface 4a of the plunger that slides with the inner surface of the cylindrical main body 3. It is prepared.
- the basic configuration of this embodiment is the same as that of the first embodiment shown in FIG. The description of the minute is omitted, and only a portion having a configuration different from the first embodiment will be described.
- a sliding resistance increasing mechanism 9 is provided on the outer surface 4a of the plunger that slides with the inner surface of the cylindrical main body 3.
- one or more protrusions 9a to 9c are provided on the outer surface 4a of the plunger.
- the axial position of the plunger 4 where the protrusions 9a to 9c are provided corresponds to the position where the pressing force of the plunger 4 starts to decrease when the deformation resistance required for folding the lens 2 is lost and the protrusions 9a to 9c are not provided. ing. With such a configuration, a sudden change in the plunger pressing force with respect to the plunger travel can be mitigated.
- a string spring 5 as an elastic body is disposed between the main body 3 and the plunger 4, and a protrusion 9a to 9c as a sliding resistance increasing mechanism is provided on the outer surface 4a of the plunger.
- a protrusion 9a to 9c as a sliding resistance increasing mechanism is provided on the outer surface 4a of the plunger.
- the intraocular lens 2 is set in a cartridge different from the force body 3 described in the case where the intraocular lens 2 is directly set in the cylindrical main body 3, and the cartridge is mounted.
- the present invention can also be applied to a cartridge-type intraocular lens insertion device used by being mounted on the main body 3.
- the elastic body 5 is not limited to the string panel, but is a foamed foam. It may be an elastic body that uses the elasticity of the material itself!
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- Health & Medical Sciences (AREA)
- Ophthalmology & Optometry (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
L'invention a pour objet un outil permettant l'insertion en toute sécurité d'une lentille intraoculaire ou cristallin artificiel à l'intérieur du globe oculaire par simple poussée d'un piston, éventuellement d'une seule main. L'outil d'insertion (1) comprend un corps tubulaire (3) destiné à contenir une lentille intraoculaire déformable (2) et à l'introduire à l'intérieur du globe oculaire, un piston (4) réciproque à l'intérieur du corps (3) poussant la lentille (2) pour la placer dans le globe oculaire et un corps élastique (5) et/ou un mécanisme augmentant la résistance au glissement placé entre le corps (3) et le piston (4). La force de pression (F) du piston (4) peut être maintenue à 60 % ou plus d'une première valeur de crête pendant la course de déplacement (X) du piston (4) après que ladite première valeur de crête ait été atteinte.
Applications Claiming Priority (2)
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JP2006-045604 | 2006-02-22 | ||
JP2006045604A JP4947484B2 (ja) | 2006-02-22 | 2006-02-22 | 眼内レンズ挿入器具 |
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WO2007097221A1 true WO2007097221A1 (fr) | 2007-08-30 |
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PCT/JP2007/052460 WO2007097221A1 (fr) | 2006-02-22 | 2007-02-13 | outil d'insertion de cristallin artificiel |
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WO (1) | WO2007097221A1 (fr) |
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