WO2016208725A1 - Intraocular lens insertion instrument, intraocular lens extraction assistance tool, and method for manufacturing intraocular lens insertion instrument - Google Patents

Intraocular lens insertion instrument, intraocular lens extraction assistance tool, and method for manufacturing intraocular lens insertion instrument Download PDF

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Publication number
WO2016208725A1
WO2016208725A1 PCT/JP2016/068852 JP2016068852W WO2016208725A1 WO 2016208725 A1 WO2016208725 A1 WO 2016208725A1 JP 2016068852 W JP2016068852 W JP 2016068852W WO 2016208725 A1 WO2016208725 A1 WO 2016208725A1
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WO
WIPO (PCT)
Prior art keywords
intraocular lens
fluid
insertion device
cylindrical member
lens insertion
Prior art date
Application number
PCT/JP2016/068852
Other languages
French (fr)
Japanese (ja)
Inventor
小林 研一
修治 安部
玄洋 翠川
Original Assignee
興和株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 興和株式会社 filed Critical 興和株式会社
Priority to JP2017525449A priority Critical patent/JP7042083B2/en
Publication of WO2016208725A1 publication Critical patent/WO2016208725A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery

Definitions

  • the present invention relates to an intraocular lens insertion device, an intraocular lens pushing aid, and a method for manufacturing an intraocular lens insertion device.
  • Intraocular lenses that are inserted as a substitute for the crystalline lens in order to correct the refraction by replacing the human turbid crystalline lens in the treatment of cataract are in practical use.
  • intraocular lens insertion surgery in the treatment of cataracts, for example, a few millimeters of incision wound (incision) is provided at the edge of the cornea, cornea, etc., and the lens is crushed by ultrasonic phacoemulsification, etc. After removal, the intraocular lens is inserted and fixed by an intraocular lens insertion device.
  • techniques for assisting insertion of an intraocular lens into the eye using an intraocular lens insertion device have been proposed (for example, Patent Documents 1, 2, and 3).
  • JP 2004-261263 A Special table 2012-505066 gazette International Publication No. 2008/149927
  • the intraocular lens housed in the intraocular lens housing portion of the device body is moved by the plunger to move within the device body and is released from the device body into the eye. .
  • the surgeon performs an operation of releasing the intraocular lens into the eye by pushing the plunger toward the instrument body with a finger.
  • the plunger is at that moment when the intraocular lens is released from the distal end of the insertion instrument.
  • the resistance force received from the intraocular lens instantaneously decreases.
  • the plunger may protrude vigorously from the instrument body.
  • the surgeon needs to adjust the force for pushing the plunger according to the movement state of the intraocular lens.
  • the technology disclosed herein has been made in view of the above circumstances, and an object thereof is to provide an intraocular lens insertion instrument that improves the operability of the plunger.
  • the intraocular lens insertion instrument of the present disclosure is provided with a substantially cylindrical instrument body having an insertion cylinder part at the tip for inserting an intraocular lens into the eye, and slidable within the instrument body, and presses the intraocular lens.
  • An intraocular lens pushing member that is moved to the insertion tube and pushed into the eye, a tubular member fixed to the instrument body, a fluid supply means for supplying fluid into the tubular member, and a tubular member And a moving member that moves under the pressure of the supplied fluid, and the intraocular lens pushing member slides in the instrument main body by being pushed by the moving member. Accordingly, the surgeon can move the intraocular lens pushing member by using the movement of the moving member pushed by the fluid without pushing the intraocular lens pushing member with a finger or the like. The member can be moved.
  • the cylindrical member extends in the sliding direction of the intraocular lens pushing member, and the moving member is a plate wall that partitions the inside of the cylindrical member into a first region and a second region, and the intraocular lens
  • the pushing member is disposed in the second region, the fluid is supplied to the first region by the fluid supply means, and the moving member is the inner wall of the cylindrical member by the pressure of the fluid supplied to the first region. It is good also as a structure which moves, contacting.
  • the plate wall body may have an elastic member that comes into contact with the inner wall of the cylindrical member.
  • the cross-sectional area of the cross section of the plate wall body in the plane perpendicular to the sliding direction of the intraocular lens pushing member may be larger than the cross-sectional area of the cross section of the instrument main body in the plane perpendicular to the sliding direction.
  • the fluid supply means may have a supply port for supplying fluid into the cylindrical member, and the inner diameter of the supply port may be smaller than the inner diameter of the cylindrical member.
  • a tube formed of a flexible member can be connected to the supply port of the fluid supply means.
  • the fluid supply means has a supply port for supplying a fluid into the cylindrical member, and an intraocular lens insertion device is further connected to the supply port.
  • the fluid supply means has a supply port for supplying the fluid in the cylindrical member, and an intraocular lens insertion device is further connected to the supply port, and is formed by a flexible member and a tube. It is good also as a structure provided with the flow-path opening-and-closing means which controls interruption
  • the intraocular lens push-out assisting tool of the present disclosure includes a cylindrical member that is fixed to a substantially cylindrical instrument body that has an insertion cylindrical portion at the tip for inserting the intraocular lens into the eye, and a fluid in the cylindrical member. And a fluid supply means provided in the cylindrical member and moving with the pressure of the fluid supplied, and provided in a slidable manner within the instrument body, pressing the intraocular lens
  • the intraocular lens pushing member that is moved to the insertion tube and pushed into the eye slides inside the instrument body when pushed by the moving member.
  • a manufacturing method of the intraocular lens insertion device of the present disclosure is a manufacturing method for the above intraocular lens insertion device, the step of inserting an intraocular lens extrusion member into the device body, and an intraocular lens extrusion member After the step of inserting, there is a step of fixing the cylindrical member provided with the fluid supply means and the moving member to the instrument body.
  • the manufacturing method may include a step of fixing the instrument body.
  • the intraocular lens insertion device of the present disclosure manufactured by the manufacturing method as in the above three examples may be shipped from the manufacturing site as a product only for the insertion device and distributed to the market.
  • the intraocular lens may be housed in an intraocular lens insertion device, and the product may be shipped from the manufacturing site and distributed to the market as a product in which the insertion device and the lens are integrated, ie, a so-called preload type (preset type) product.
  • an intraocular lens insertion device that improves the operability of the plunger can be provided.
  • FIG. 6A and FIG. 6B are diagrams illustrating the movement of the plunger of the intraocular lens insertion device in one embodiment.
  • Fig.7 (a) and FIG.7 (b) are figures which show the manufacturing method of the intraocular lens insertion instrument in one Embodiment.
  • FIG. 8B are diagrams showing a method for manufacturing an intraocular lens insertion device in one modification.
  • FIG. 9A and FIG. 9B are diagrams showing a method for manufacturing an intraocular lens insertion device in one modification.
  • FIG. 10A and FIG. 10B are diagrams showing a schematic configuration of an intraocular lens insertion device according to a modification.
  • FIG. 11 is a diagram illustrating a schematic configuration of an intraocular lens insertion device according to a modification.
  • FIG. 12 is a diagram illustrating a schematic configuration of an intraocular lens insertion device according to a modification.
  • FIG. 1A is a plan view of the intraocular lens insertion instrument 1 when the stage lid 13 is opened
  • FIG. 1B is a side view of the intraocular lens insertion instrument 1 when the stage lid 13 is closed.
  • the intraocular lens insertion instrument 1 includes a nozzle body 10 as an instrument body, a plunger 30 as an intraocular lens pushing member, a stage unit 12 and a stage lid unit 13 as an intraocular lens storage unit, And an intraocular lens push-out assisting tool 20 that assists in pushing out the lens.
  • the stage unit 12 is provided integrally with the nozzle body 10 or separately.
  • a plunger 30 is inserted into the nozzle body 10.
  • the intraocular lens 2 is set on the stage unit 12.
  • the stage lid portion 13 is formed integrally with the stage portion 12.
  • the intraocular lens extrusion assisting tool 20 is a hollow cylindrical member, and one end thereof is engaged with the holding portion 11 of the nozzle body 10.
  • the shape of the intraocular lens extrusion assisting tool 20 is not limited to a cylinder, and can be formed in an arbitrary shape.
  • the nozzle main body 10 of the intraocular lens insertion device 1 is formed in a cylindrical shape having a substantially rectangular cross section, and one end of the nozzle body 10 is greatly open (hereinafter, the side having the large opening is referred to as the rear end 10b), and the other side.
  • tip part 10a narrowed down are provided in the edge part. As shown in FIG.1 (b), the front-end
  • the plunger 30 is inserted into the nozzle body 10 and can reciprocate.
  • the direction from the rear end 10b of the nozzle body 10 to the front end 10a is the front direction
  • the opposite direction is the rear direction
  • the front side of the page in FIG. 1A is the upper direction
  • the reverse direction is the lower direction
  • the front side of the page is the left direction
  • the opposite direction is the right direction.
  • the upper side is the front side of the optical axis of the lens body 2a, which will be described later
  • the lower side is the rear side of the optical axis of the lens body 2a
  • the front side is the front side in the pressing direction by the plunger 30, and the rear side is pressed by the plunger 30 Corresponds to the rear side.
  • a stage portion 12 for setting the intraocular lens 2 is provided on the rear side of the nozzle portion 15 in the nozzle body 10.
  • the stage portion 12 is configured such that the upper side of the nozzle body 10 is opened by opening the stage lid portion 13.
  • a positioning member 50 is attached to the stage portion 12 from the lower side of the nozzle body 10. By this positioning member 50, the intraocular lens 2 is stably held in the stage portion 12 even before use (during transportation).
  • the intraocular lens 2 is placed on the stage unit 12 and the front side of the optical axis is in a state where the stage lid unit 13 is opened and the positioning member 50 is attached to the stage unit 12. Set to be on top. Then, after the stage lid 13 is closed, it is shipped and sold. Then, the user removes the positioning member 50 with the stage lid portion 13 closed, and then pushes the plunger 30 into the distal end side of the nozzle body 10. As a result, the intraocular lens 2 is pressed by the plunger 30 and moved to the nozzle part 15, and then the intraocular lens 2 is released into the eyeball from the distal end part 10 a.
  • the nozzle main body 10, the plunger 30, and the positioning member 50 in the intraocular lens insertion device 1 are formed of a resin material such as polypropylene.
  • Polypropylene is a material with a proven track record in medical equipment and high reliability such as chemical resistance.
  • the intraocular lens extrusion assisting tool 20 has a cylindrical tubular member 20 a extending in the extending direction of the plunger 30 inserted into the nozzle body 10. Moreover, the through-hole 20b which penetrates the cylindrical member 20a is provided in the side surface of the cylindrical member 20a.
  • a packing 20c as a moving member is provided on the rear end side of the cylindrical member 20a so as to contact the inner wall of the cylindrical member 20a. The packing 20c is slidably provided on the inner wall while being in close contact with the inner wall of the cylindrical member 20a. It is desirable that the packing 20c has a rigidity that does not bend when sliding.
  • the packing 20c does not have such rigidity, if the outer diameter L2 of the pressing plate portion 33 is set to be approximately equal to the inner diameter of the packing 20c, the packing 20c can be prevented from being bent during sliding. . Furthermore, if the diameter of the packing 20c is larger than the inner diameter L1 of the cylindrical member 20a, the pushing load on the packing 20c when the packing 20c is slid increases, and from there, the pushing out as the diameter of the packing 20c approaches the inner diameter L1. The load becomes smaller.
  • the rear end of the intraocular lens extrusion assisting tool 20 is provided with a fluid supply unit 20d as a fluid supply means for supplying a fluid to a space surrounded by the intraocular lens extrusion assisting tool 20 and the packing 20c. Yes.
  • a region surrounded by the cylindrical member 20a, the packing 20c, and the fluid supply unit 20d is a sealed space.
  • the region on the fluid supply part 20d side is defined as the first region 20f with the packing 20c as a boundary, and the region on the plunger 30 side inserted into the nozzle body 10 is defined as the second region.
  • the through-hole 20b has a function of causing the fluid supplied to the first region 20f to flow out of the intraocular lens push-out assisting tool 20.
  • an engagement portion 20 h for engaging with the hold portion 11 of the nozzle body 10 is provided on the distal end side of the intraocular lens push-out assisting tool 20.
  • the engaging portion 20h is an intraocular lens in a state of being received by the nozzle body 10.
  • a pair of extrusion assisting tools 20 are provided in the vertical direction.
  • Each engagement portion 20h is provided with a through hole 20i through which a part of the hold portion 11 passes.
  • both ends of the hold part 11 of the nozzle body 10 are inserted through the through holes 20i of the engaging part 20h. Further, notches 11 a are provided at both ends of the hold unit 11. For this reason, once the engaging part 20h of the intraocular lens pushing auxiliary tool 20 is attached to the hold part 11, the engagement between the engaging part 20h and the hold part 11 is not released by the notch 11a.
  • the notch may be provided in the engaging portion 20h instead of the holding portion 11 or in addition to the holding portion 11 as long as the engaging portion 20h and the holding portion 11 are not disengaged.
  • the intraocular lens extrusion assisting tool 20 When the intraocular lens extrusion assisting tool 20 is attached to the nozzle main body 10, at least one of the intraocular lens extrusion assisting tool 20 and the nozzle main body 10 is connected so that the second region 20 g does not become a sealed space. It is necessary to provide an opening structure. This is because the air existing in the second region 20g before the attachment of the intraocular lens pushing aid 20 and the nozzle body 10 needs to be discharged to the outside as the packing 20c moves.
  • An opening 20e through which the fluid supplied from the tube 40 passes is provided on the rear end face of the fluid supply unit 20d.
  • the fluid supply unit 20d has a front side connected to the rear end of the cylindrical member 20a and a rear side connectable to the tip of the tube 40.
  • An inner diameter L1 of the cylindrical member 20a is provided to be larger than an outer diameter L2 of the pressing plate portion 33 of the plunger 30.
  • the pushing speed of the packing 20c and the plunger 30 becomes slower as the inner diameter L1 of the cylindrical member 20a becomes larger, but the stability by the stronger pushing force is increased. Extrusion is possible.
  • the opening diameter L3 of the opening 20e of the fluid supply unit 20d is provided to be smaller than the inner diameter L1 of the cylindrical member 20a.
  • the opening 20e is made into the dimension which can be engaged with the internal diameter or outer diameter of a general medical tube.
  • the opening 20e and the tube 40 may be connected via a connector.
  • a highly versatile medical tube can be connected to the fluid supply unit 20d, and it is not necessary to prepare a special tube.
  • a fluid supply source (not shown) for supplying fluid into the first region 20f is connected to the other end of the tube 40 connected to the fluid supply unit 20d. Examples of the fluid supply source include a compressor for supplying compressed air and a pump for supplying cold / hot water.
  • FIG. 2 is a diagram showing a schematic configuration of the intraocular lens 2.
  • 2A is a plan view and FIG. 2B is a side view.
  • the intraocular lens 2 is a so-called three-piece type.
  • the intraocular lens 2 is formed of a lens body 2a having a predetermined refractive power and two beard-shaped support portions 2b, 2b connected to the lens body 2a for holding the lens body 2a in the eyeball. Has been.
  • the lens body 2a and the support portion 2b are made of a flexible resin material.
  • the intraocular lens is arranged such that one of the two support portions 2b and 2b is disposed on the rear side of the lens body 2a and the other is disposed on the front side of the lens body. 2 is set.
  • FIG. 3 shows a plan view of the nozzle body 10.
  • the intraocular lens 2 is set on the stage unit 12. In this state, the intraocular lens 2 is pressed by the plunger 30 and is released from the distal end portion 10a.
  • a through hole 10 c whose cross-sectional shape changes according to a change in the outer shape of the nozzle body 10 is provided in the nozzle body 10.
  • the intraocular lens 2 is released, the intraocular lens 2 is deformed and folded according to a change in the cross-sectional shape of the through hole 10c in the nozzle body 10, and is formed on the patient's eyeball. It is released after being transformed into a shape that is easy to enter an incision.
  • the tip portion 10a has a shape cut obliquely so that the upper region of the nozzle portion 15 is in front of the lower region.
  • the shape of the tip portion 10a that is obliquely cut may be linearly obliquely cut when viewed from the left-right direction, or may have a bulge outward, that is, a curved shape. It may be cut into
  • a stage groove 12 a having a width slightly larger than the diameter of the lens body 2 a of the intraocular lens 2 is formed in the stage portion 12.
  • the dimension in the front-rear direction of the stage groove 12 a is set to be larger than the maximum width dimension including the support portions 2 b and 2 b extending on both sides of the intraocular lens 2.
  • a set surface 12b is formed by the bottom surface of the stage groove 12a. The vertical position of the set surface 12b is set higher than the height position of the bottom surface of the through hole 10c of the nozzle body 10, and the set surface 12b and the bottom surface of the through hole 10c are connected by a bottom slope 10d. .
  • the stage portion 12 and the stage lid portion 13 are integrally formed.
  • the stage lid portion 13 has the same size in the front-rear direction as the stage portion 12.
  • the stage lid portion 13 is connected by a thin plate-like connecting portion 14 formed by extending the side surface of the stage portion 12 to the stage lid portion 13 side.
  • the connecting portion 14 is formed to be bendable at the center portion, and the stage lid portion 13 can be closed by overlapping the stage portion 12 from above by bending the connecting portion 14.
  • stage lid 13 ribs 13 a and 13 b are provided on the surface facing the set surface 12 b when the lid is closed in order to reinforce the stage lid 13 and stabilize the position of the intraocular lens 2. Further, a guide protrusion 13 c is provided as a guide on the upper side of the plunger 30.
  • the stage lid 13 is provided with an injection hole 16 for injecting a viscoelastic material for smooth movement of the intraocular lens in the nozzle.
  • the protrusion 17 has a function of making it easier to inject the viscoelastic material by guiding the needle of the syringe to be injected into the injection hole 16.
  • FIG. 4 shows a schematic configuration of the positioning member 50.
  • FIG. 4A shows a plan view of the positioning member 50
  • FIG. 4B shows a left side view of the positioning member 50.
  • the positioning member 50 is configured as a separate body from the nozzle main body 10, and has a structure in which a pair of side wall portions 51, 51 are connected by a connecting portion 52. At the lower ends of the respective side wall portions 51, holding portions 53, 53 extending outward and extending are formed.
  • a pair of first mounting portions 54 and 54 protruding upward are formed at the upper end portions of the side wall portions 51 and 51, respectively. Further, first positioning portions 55 and 55 are formed to protrude from the outer peripheral side of the upper end surfaces of the first placement portions 54 and 54. The distance between the inner sides of the first positioning portions 55 and 55 is set slightly larger than the diameter of the lens body 2 a of the intraocular lens 2.
  • a pair of second mounting portions 56 and 56 projecting upward are formed at both ends in the front-rear direction inside the side wall portions 51 and 51.
  • the heights of the upper surfaces of the second mounting parts 56 and 56 are equal to the heights of the upper surfaces of the first mounting parts 54 and 54.
  • second positioning portions 57 and 57 that protrude further upward are formed on the outer portions of the upper surfaces of the second placement portions 56 and 56 over the entire left and right direction of the second placement portions 56 and 56.
  • the distance between the inner sides of the second positioning portions 57 and 57 is set to be slightly larger than the diameter dimension of the lens body 2 a of the intraocular lens 2.
  • locking claws 58, 58 that slightly protrude in the front-rear direction are formed on the upper ends of the second placement portions 56, 56 over the entire left-right direction.
  • the positioning member 50 is assembled from below the set surface 12b of the nozzle body 10.
  • the set surface 12b of the nozzle body 10 is formed with a set surface through hole 12c that penetrates the set surface 12b in the thickness direction.
  • the outer shape of the set surface through-hole 12c is a substantially similar shape that is slightly larger than the shape of the first placement portions 54 and 54 and the second placement portions 56 and 56 of the positioning member 50 as viewed from above.
  • the positioning member 50 is assembled from the lower side of the nozzle body 10, and the first placement portions 54 and 54 and the second placement portions 56 and 56 are fixed in a state of protruding from the set surface 12b.
  • the bottom surface of the outer peripheral portion of the lens body 2a is placed on the upper surfaces of the first placement portions 54 and 54 and the second placement portions 56 and 56.
  • the position of the lens body 2a is restricted with respect to the horizontal direction (the direction horizontal to the set surface 12b) by the first positioning portions 55, 55 and the second positioning portions 57, 57.
  • the positioning member 50 When inserting the intraocular lens 2 into the eyeball, the positioning member 50 is removed from the nozzle body 10 after an appropriate amount of viscoelastic material is injected from the injection hole 16. As a result, the first placement portions 54 and 54 and the second placement portions 56 and 56 that have supported the lens body 2a of the intraocular lens 2 are retracted from the set surface 12b, and the intraocular lens 2 is on the set surface 12b. Is movably mounted.
  • the distal end portion 10a of the nozzle portion 15 of the nozzle body 10 is inserted into the incision provided in the eye tissue.
  • the distal end portion 10a has an oblique opening shape, it can be easily inserted into the incision.
  • the pressing plate portion 33 of the plunger 30 is pushed into the distal end side of the nozzle body 10.
  • the plunger 30 has a slightly larger longitudinal length than the nozzle body 10. And it forms from the action part 31 of the front end side based on a column shape, and the insertion part 32 of the rear end side based on a rectangular rod shape. And the action part 31 is comprised including the cylindrical part 31a made into the column shape, and the thin plate-shaped flat part 31b extended in the left-right direction of the cylindrical part 31a.
  • a notch 31 c is formed at the tip of the action part 31.
  • the notch 31c is formed in a groove shape that opens upward in the action portion 31 and penetrates in the left-right direction.
  • the groove wall on the distal end side of the notch 31 c is formed with an inclined surface that goes upward as it goes to the distal end side of the action portion 31.
  • the insertion part 32 has a substantially H-shaped cross section as a whole, and the horizontal and vertical dimensions thereof are set slightly smaller than the through hole 10 c of the nozzle body 10.
  • a disc-shaped pressing plate portion 33 is formed at the rear end of the insertion portion 32 so as to spread in the vertical and horizontal directions.
  • a claw portion 32 a that protrudes upward from the insertion portion 32 and that can move up and down by the elasticity of the material of the plunger 30 is formed at a portion of the insertion portion 32 that is ahead of the center in the front-rear direction.
  • the locking hole 10e shown in FIG. 3 provided in the thickness direction on the upper surface of the nozzle body 10 and the claw portion 32a are engaged.
  • the relative position between the nozzle body 10 and the plunger 30 in the initial state is determined.
  • the claw portion 32a and the locking hole 10e are formed at the positions where the distal end of the action portion 31 is located on the rear side of the lens body 2a of the intraocular lens 2 set on the stage portion 12 in the engaged state.
  • the support portion 2b on the rear side of the main body 2a is set so that the cutout portion 31c can be supported from below.
  • the plunger 30 Prior to the accommodation of the intraocular lens 2 of the intraocular lens insertion device 1 configured as described above, the plunger 30 is inserted into the nozzle body 10 and disposed at the initial position. Further, as described above, the positioning member 50 is attached to the nozzle body 10 from below the set surface 12b. Thereby, the 1st mounting part 54 and the 2nd mounting part 56 of the positioning member 50 are hold
  • the lens body 2 a of the intraocular lens 2 is placed and positioned on the upper surfaces of the first placement part 54 and the second placement part 56 with the support part 2 b facing the front-rear direction of the nozzle body 10.
  • a part of the support portion 2b on the rear side of the intraocular lens 2 is sandwiched between the notches 31c of the plunger 30 and is supported by the bottom surface thereof.
  • FIG. 6 illustrates the positional relationship between the plunger 30 and the packing 20c of the plunger push-out assisting tool 20 when the intraocular lens 2 moves to the tip 10a of the nozzle body 10.
  • the operator operates the fluid supply source connected to the tube 40 to maintain a constant level.
  • a fluid having a flow rate is supplied to the first region 20f via the tube 40 and the fluid supply unit 20d.
  • the first region 20f is filled with fluid.
  • the packing 20c moves toward the nozzle body 10 and presses the plunger 30 toward the nozzle body 10 to move it.
  • the intraocular lens 2 can be moved to the tip portion 10 a side of the nozzle body 10.
  • the pushing of the plunger 30 by the packing 20c is more stable.
  • the function of the through hole 20b will be described. As shown in FIG. 6B, when the packing 20c moves beyond the hole 20b, the fluid supplied to the first region 20f flows out from the hole 20b.
  • the hole 20b is not blocked by the operator's hand.
  • the fluid flows out of the cylindrical member 20a from the hole 20b.
  • the packing 20c stops at the position shown in FIG. 6B without being pushed by the fluid.
  • the packing 20c pushes the plunger 30 toward the tip 10a side of the nozzle body 10. The continuing phenomenon can be avoided. As a result, it is possible to prevent the intraocular lens 2 from being released from the distal end portion 10a of the nozzle body 10 against the operator's intention.
  • the hole 20b is considered to be blocked by the operator's hand.
  • the fluid when the fluid is supplied to the first region 20f after the packing 20c has moved to the position illustrated in FIG. 6B, the fluid does not flow out of the cylindrical member 20a from the hole 20b.
  • the packing 20c is pushed by the fluid and further moves from the position illustrated in FIG. 6B to the tip portion 10a side of the nozzle body.
  • the plunger 30 is pressed and moved by the packing 20c, and further moves the intraocular lens 2 to the tip portion 10a side of the nozzle body 10.
  • the operator releases the fluid from the hole 20b and removes the packing by releasing the finger from the hole 20b.
  • the movement of 20c can be stopped. Therefore, the surgeon can control the movement of the packing 20c pushed by the fluid by closing the hole 20b with a finger or the like, or separating the finger or the like that has closed the hole 20b from the hole 20. Thereby, the operator does not need to operate the plunger 30 with a finger, and can concentrate on other operations and treatments such as adjustment of the position of the nozzle body 10 with respect to the incision.
  • the fluid is supplied to the intraocular lens extrusion assisting tool 20 at a constant flow rate using the fluid supply source, so that the movement of the packing 20c and the plunger 30 can be moved at a constant speed.
  • the intraocular lens insertion instrument 1 of this embodiment the intraocular lens 2 can be moved and inserted into the eye at a stable moving speed in the nozzle body 10. Therefore, the intraocular lens can be more stably ejected into the eye than a conventional intraocular lens insertion device.
  • the burden on the incision provided in the eyeball is reduced.
  • the plunger 30 shown in FIG. 5 is attached to the nozzle body 10 shown in FIG. 3 from the rear end portion 10b side of the nozzle body 10. insert.
  • the claw portion 32a of the plunger 30 inserted into the nozzle body 10 engages with the locking hole 10e, and the nozzle body 10 and the plunger 30 are relatively positioned.
  • the intraocular lens push-out assisting tool 20 is guided so that the rear end portion 10b of the nozzle body 10, the insertion portion 32 of the plunger 30 and the pressing plate portion 33 are accommodated in the cylindrical member 20a. Then, both ends of the holding portion 11 of the nozzle body 10 are inserted into the respective through holes 20i of the intraocular lens push-out assisting tool 20, and the engaging portion 20h and the holding portion 11 are engaged. Thereby, the assembly of the intraocular lens insertion device 1 according to the present embodiment is completed.
  • the configuration of the insertion portion and the like is not limited to the above-described embodiment, and various modifications can be made within the scope that does not lose the technical idea of the present invention. Is possible.
  • the notch 11a may not be provided.
  • the packing 20c and the pressing plate portion 33 of the plunger 30 are provided as separate bodies as in the state shown in FIG. 6A, but the pressing plate portion 33 and the packing 20c are integrated in advance. You may provide as.
  • Modification 1 A method for manufacturing the intraocular lens insertion device 100 in Modification 1 will be described with reference to FIG.
  • the intraocular lens extrusion assisting tool 20 is fixed so that the opening 20j at one end of the intraocular lens extrusion assisting tool 20 is vertically upward.
  • the plunger 30 is disposed in the intraocular lens pushing aid 20.
  • the pressing plate portion 33 of the plunger 30 is placed on the packing 20c.
  • the nozzle body 200 is attached to the intraocular lens pushing assisting tool 20.
  • the nozzle body 200 in the present modification has a configuration in which the rear end portion of the nozzle body 10 in the above embodiment is deleted from the stage portion 12 and the hold portion 11 is connected to the rear end side of the stage portion 12. It has become. Therefore, when the nozzle body 200 is attached to the intraocular lens push-out assisting tool 20, the tip of the plunger 30 is inserted into the stage part 12, and both ends of the hold part 11 are the engaging parts 20h of the intraocular lens push-out assisting tool 20. Is inserted through the through hole 20i. As a result, as shown in FIG. 8B, the assembly of the intraocular lens insertion device 100 according to this modification is completed.
  • the intraocular lens push-out aid 20 is fixed so that the opening 20j at one end of the intraocular lens push-out aid 20 is vertically upward, but the intraocular lens insertion device 100 can be assembled.
  • the posture of the intraocular lens extrusion assisting tool 20 is not limited to this.
  • the plunger 30 is placed in the intraocular lens push-out assisting tool 20
  • the pressing plate portion 33 of the plunger 30 is bonded to the packing 20c, or a depression is formed in the packing 20c to form the pressing plate portion 33 in the depression.
  • the intraocular lens insertion aid 100 can be assembled with the intraocular lens push-out assisting tool 20 in a posture other than vertically upward.
  • the nozzle body 10 and the cylindrical member 20a of the intraocular lens push-out assisting tool 20 in the above embodiment are integrally formed in advance.
  • the intraocular lens push-out assisting tool 20 of the intraocular lens insertion device 300 has the engagement portion 20h of the intraocular lens push-out assisting tool 20 in the above embodiment removed, and one end of the cylindrical member 20a is the nozzle body It is joined to the hold unit 18.
  • the plunger 30 is inserted through the cylindrical member 20 a, and the tip of the plunger 30 is further moved from the rear end portion 10 b of the nozzle body 10 to the nozzle body 10. Plugged in.
  • the packing 20c is fitted into the cylindrical member 20a from the rear end side of the cylindrical member 20a.
  • the fluid supply part 20d is joined to the rear end of the cylindrical member 20a.
  • FIG. 9B the assembly of the intraocular lens insertion device 300 according to this modification is completed.
  • a hook 400a is provided on the distal end portion 10a side of the nozzle body 10 of the hold portion 11 in a side view of the intraocular lens insertion device 400 (FIG. 10A).
  • one hook 400 a is provided on each of the upper end side and the lower end side of the hold unit 11.
  • a nozzle cover 420 that protects the nozzle body 10 can be attached to the hook 400a.
  • the attachment structure of the nozzle cover 420 that protects the nozzle body 10 is not limited to the hook 400a, and may be an attachment structure that fits by press fitting.
  • the intraocular lens insertion device 400 when the operator is holding the intraocular lens insertion device 400, it is possible to prevent the positioning member 50 from being unintentionally detached from the stage portion 12 or opening the stage lid portion 13 unintentionally. Furthermore, since the nozzle body 10 and the plunger 30 are protected by the intraocular lens extrusion assisting tool 20 and the nozzle cover 420, it is not necessary to use a so-called blister case for housing the intraocular lens insertion instrument, It is only necessary to store the intraocular lens insertion device 400 in a sterile bag as it is.
  • a cock 510 is provided in the tube 40 connected to the opening 20e on the rear end face of the fluid supply unit 20d.
  • the tip of a syringe barrel 520 is connected to the cock 510.
  • the cock 510 corresponds to an example of a flow path switching unit.
  • the packing 20c may adhere to the inner wall of the cylindrical member 20a of the intraocular lens push-out assisting tool 20.
  • the air pressure in the first region 20f increases. Then, there is a possibility that the packing 20c is released from being fixed to the inner wall of the tubular member 20a and the movement of the packing 20c starts at a timing not intended by the operator.
  • the surgeon operates the plunger 520a to send air from the syringe barrel 520 to the first region 20f before starting the supply of air to the first region 20f by the fluid supply source.
  • the fixing of the packing 20c to the inner wall of the cylindrical member 20a can be released.
  • a method for releasing the fixation of the packing 20c not only supplying air but also sucking air may be used.
  • the supply of air to the first region 20f by the fluid supply source can be started after the fixation of the packing 20c is released, the movement of the packing 20c starts almost simultaneously with the start of air supply. can do.
  • the air is supplied to the first region 20f by the fluid supply source, the movement of the packing 20c can be prevented from starting at a timing not intended by the operator as described above.
  • the surgeon pulls back the plunger 520a of the syringe barrel 520 to the rear end side of the syringe barrel 520, so that the nozzle body
  • the plunger 30 that has moved to the tip portion 10a side of 10 can be pulled back to the fluid supply portion 20d side again.
  • the fluid supplied from the fluid supply source and the syringe barrel 520 has been described as air.
  • the fluid to be used is not limited to air.
  • the shape of the syringe barrel 520 is not limited to the shape shown in the present modified example as long as it has a function of supplying or sucking fluid.
  • a cock 610 is provided in the tube 40 connected to the opening 20e on the rear end face of the fluid supply unit 20d.
  • the flow path of the fluid supplied from the fluid supply source in the tube 40 is blocked in advance by the cock 610.
  • the operator operates the cock 610 to open the fluid flow path. Since the supply of fluid to the first region 20f by the fluid supply source can be controlled by the cock 610 in this manner, for example, during preparation for the operator to use the intraocular lens insertion device 600, it is not intended. It can be prevented that the fluid is supplied to the first region 20f by the fluid supply source and the packing 20c starts to move.
  • the cock 610 corresponds to an example of the channel opening / closing means of the tube 40.
  • Intraocular lens insertion device 2 Intraocular lens 2a Lens body 2b Support unit 10, 200 Nozzle body 20 Intraocular lens extrusion assisting tool 20a Tubular member 20b Hole 20c Packing 20d Fluid supply unit 20e Opening 20f First Region 20g Second region 20h Engagement portion 20i Through hole 30 Plunger 33 Pressing plate portion 510, 610 Cock 520 Syringe

Abstract

Provided is an intraocular lens insertion instrument whereby operability of a plunger is enhanced. The intraocular lens insertion instrument according to the present invention is provided with: a substantially cylindrical instrument body having at a distal end thereof an insertion cylinder for inserting an intraocular lens into an eye; an intraocular lens extrusion member for pressing an intraocular lens, moving the intraocular lens to the insertion cylinder, and pushing the intraocular lens out into the eye, the intraocular lens extrusion member being provided so as to be able to slide through the inside of the instrument body; a cylindrical member fixed to the instrument body; a fluid supply means for supplying a fluid into the cylindrical member; and a moving member for moving due to pressure of the supplied fluid, the moving member being provided in the cylindrical member; the intraocular lens extrusion member being configured so as to slide through the inside of the instrument body by being pushed by the moving member.

Description

眼内レンズ挿入器具、眼内レンズ押出補助具および眼内レンズ挿入器具の製造方法Intraocular lens insertion device, intraocular lens pushing aid, and method for manufacturing intraocular lens insertion device
 本発明は、眼内レンズ挿入器具、眼内レンズ押出補助具および眼内レンズ挿入器具の製造方法に関する。 The present invention relates to an intraocular lens insertion device, an intraocular lens pushing aid, and a method for manufacturing an intraocular lens insertion device.
 白内障治療においてヒト混濁水晶体を置換して屈折を補正するために水晶体の代用として挿入される眼内レンズが実用に供されている。白内障治療における眼内レンズ挿入手術においては、例えば角膜、強角膜などの縁に数ミリの切開の創口(切開創)が設けられ、超音波水晶体乳化吸引術などにより水晶体が粉砕されて切開創から取り除かれた後、眼内レンズ挿入器具により眼内レンズが挿入及び固定される。そして、近年においては、眼内レンズ挿入器具を用いた眼内レンズの眼内への挿入を補助する技術が提案されている(例えば、特許文献1、2、3)。 Intraocular lenses that are inserted as a substitute for the crystalline lens in order to correct the refraction by replacing the human turbid crystalline lens in the treatment of cataract are in practical use. In intraocular lens insertion surgery in the treatment of cataracts, for example, a few millimeters of incision wound (incision) is provided at the edge of the cornea, cornea, etc., and the lens is crushed by ultrasonic phacoemulsification, etc. After removal, the intraocular lens is inserted and fixed by an intraocular lens insertion device. In recent years, techniques for assisting insertion of an intraocular lens into the eye using an intraocular lens insertion device have been proposed (for example, Patent Documents 1, 2, and 3).
特開2004-261263号公報JP 2004-261263 A 特表2012-505066号公報Special table 2012-505066 gazette 国際公開第2008/149927号International Publication No. 2008/149927
 従来の眼内レンズ挿入器具においては、器具本体の眼内レンズ収納部に収納された眼内レンズがプランジャーにより押圧されることで器具本体内を移動して器具本体から眼内に放出される。術者は、プランジャーを指で器具本体側に押し込むことで、眼内レンズを眼内に放出する操作を行う。 In a conventional intraocular lens insertion device, the intraocular lens housed in the intraocular lens housing portion of the device body is moved by the plunger to move within the device body and is released from the device body into the eye. . The surgeon performs an operation of releasing the intraocular lens into the eye by pushing the plunger toward the instrument body with a finger.
 しかしながら、術者がプランジャーを指で押して眼内レンズを器具本体から眼内に放出する一連の動作中において、眼内レンズが挿入器具の先端から外部に放出されるその瞬間においては、プランジャーが眼内レンズから受ける抵抗力は瞬間的に低下する。このとき、術者がプランジャーを押す力を緩めないと、プランジャーが器具本体から勢いよく突出する可能性がある。このように、術者は、プランジャーを指で押す場合、眼内レンズの移動状況に応じてプランジャーを押す力を調整する必要がある。 However, during a series of operations in which the surgeon pushes the plunger with a finger to release the intraocular lens from the instrument body into the eye, the plunger is at that moment when the intraocular lens is released from the distal end of the insertion instrument. The resistance force received from the intraocular lens instantaneously decreases. At this time, if the surgeon does not loosen the force of pressing the plunger, the plunger may protrude vigorously from the instrument body. As described above, when the surgeon pushes the plunger with a finger, the surgeon needs to adjust the force for pushing the plunger according to the movement state of the intraocular lens.
 本件開示の技術は、上記の事情に鑑みてなされたものであり、その目的とするところは、プランジャーの操作性を向上させる眼内レンズ挿入器具を提供することである。 The technology disclosed herein has been made in view of the above circumstances, and an object thereof is to provide an intraocular lens insertion instrument that improves the operability of the plunger.
 本件開示の眼内レンズ挿入器具は、眼内レンズを眼内に挿入する挿入筒部を先端に有する略筒状の器具本体と、器具本体内を摺動可能に設けられ、眼内レンズを押圧して挿入筒部に移動させて眼内に押し出す眼内レンズ押出部材と、器具本体に固定される筒状部材と、筒状部材内に流体を供給する流体供給手段と、筒状部材内に設けられ、供給される流体の圧力で移動する移動部材と、を備え、眼内レンズ押出部材は、移動部材によって押されることにより器具本体内を摺動する。これにより、術者は指などで眼内レンズ押出部材を押すことなく流体によって押される移動部材の移動を利用して眼内レンズ押出部材を移動することができるため、より安定した眼内レンズ押出部材の移動が可能となる。 The intraocular lens insertion instrument of the present disclosure is provided with a substantially cylindrical instrument body having an insertion cylinder part at the tip for inserting an intraocular lens into the eye, and slidable within the instrument body, and presses the intraocular lens. An intraocular lens pushing member that is moved to the insertion tube and pushed into the eye, a tubular member fixed to the instrument body, a fluid supply means for supplying fluid into the tubular member, and a tubular member And a moving member that moves under the pressure of the supplied fluid, and the intraocular lens pushing member slides in the instrument main body by being pushed by the moving member. Accordingly, the surgeon can move the intraocular lens pushing member by using the movement of the moving member pushed by the fluid without pushing the intraocular lens pushing member with a finger or the like. The member can be moved.
 また、筒状部材は、眼内レンズ押出部材の摺動方向に延在し、移動部材は、筒状部材内を第1の領域と第2の領域とに仕切る板壁体であり、眼内レンズ押出部材は、第2の領域内に配置されており、流体供給手段によって流体が第1の領域に供給され、移動部材は、第1の領域に供給される流体の圧力で筒状部材の内壁に当接しながら移動する構成としてもよい。 The cylindrical member extends in the sliding direction of the intraocular lens pushing member, and the moving member is a plate wall that partitions the inside of the cylindrical member into a first region and a second region, and the intraocular lens The pushing member is disposed in the second region, the fluid is supplied to the first region by the fluid supply means, and the moving member is the inner wall of the cylindrical member by the pressure of the fluid supplied to the first region. It is good also as a structure which moves, contacting.
 さらに、板壁体は筒状部材の内壁と当接する弾性部材を有してもよい。また、眼内レンズ押出部材の摺動方向に垂直な面における板壁体の断面の断面積が、摺動方向に垂直な面における器具本体の断面の断面積よりも大きくなるようにしてもよい。また、流体供給手段は、筒状部材内に流体を供給する供給口を有し、供給口の内径は、筒状部材の内径よりも小さくなるようにしてもよい。さらに、流体供給手段の供給口には、軟性部材により形成されるチューブが接続可能である。また、流体供給手段は、筒状部材内に流体を供給する供給口を有し、眼内レンズ挿入器具がさらに、供給口に接続された、軟性部材により形成されるチューブと、チューブに設けられた、流体の流路と流体の流路とは別の流路とを切り替える流路切替手段と、別の流路に接続される注射筒とを備える構成としてもよい。あるいは、流体供給手段は、筒状部材内に前記流体を供給する供給口を有し、眼内レンズ挿入器具がさらに、供給口に接続された、軟性部材により形成されるチューブと、チューブに設けられた、流体の流路の遮断および開放を制御する流路開閉手段とを備える構成としてもよい。 Furthermore, the plate wall body may have an elastic member that comes into contact with the inner wall of the cylindrical member. In addition, the cross-sectional area of the cross section of the plate wall body in the plane perpendicular to the sliding direction of the intraocular lens pushing member may be larger than the cross-sectional area of the cross section of the instrument main body in the plane perpendicular to the sliding direction. The fluid supply means may have a supply port for supplying fluid into the cylindrical member, and the inner diameter of the supply port may be smaller than the inner diameter of the cylindrical member. Furthermore, a tube formed of a flexible member can be connected to the supply port of the fluid supply means. The fluid supply means has a supply port for supplying a fluid into the cylindrical member, and an intraocular lens insertion device is further connected to the supply port. In addition, it may be configured to include a flow path switching means for switching between a fluid flow path and a flow path different from the fluid flow path, and a syringe barrel connected to the separate flow path. Alternatively, the fluid supply means has a supply port for supplying the fluid in the cylindrical member, and an intraocular lens insertion device is further connected to the supply port, and is formed by a flexible member and a tube. It is good also as a structure provided with the flow-path opening-and-closing means which controls interruption | blocking and opening | release of the fluid flow path.
 そして、本件開示の眼内レンズ押出補助具は、眼内レンズを眼内に挿入する挿入筒部を先端に有する略筒状の器具本体に固定される筒状部材と、筒状部材内に流体を供給する流体供給手段と、筒状部材内に設けられ、供給される流体の圧力で移動する移動部材と、を備え、器具本体内を摺動可能に設けられ、眼内レンズを押圧して挿入筒部に移動させて眼内に押し出す眼内レンズ押出部材が、移動部材によって押されることにより器具本体内を摺動する。 The intraocular lens push-out assisting tool of the present disclosure includes a cylindrical member that is fixed to a substantially cylindrical instrument body that has an insertion cylindrical portion at the tip for inserting the intraocular lens into the eye, and a fluid in the cylindrical member. And a fluid supply means provided in the cylindrical member and moving with the pressure of the fluid supplied, and provided in a slidable manner within the instrument body, pressing the intraocular lens The intraocular lens pushing member that is moved to the insertion tube and pushed into the eye slides inside the instrument body when pushed by the moving member.
 また、本件開示の眼内レンズ挿入器具の製造方法は、上記の眼内レンズ挿入器具に対する製造方法であって、器具本体に、眼内レンズ押出部材を挿入する工程と、眼内レンズ押出部材を挿入する工程の後に、器具本体に、流体供給手段および移動部材が設けられている筒状部材を固定する工程を有する。あるいは別の製造方法として、流体供給手段および移動部材が設けられている筒状部材に、眼内レンズ押出部材を挿入する工程と、眼内レンズ押出部材を挿入する工程の後に、筒状部材に、器具本体を固定する工程を有する製造方法でもよい。あるいは更に別の製造方法として、器具本体とあらかじめ一体的に成形された筒状部材に、眼内レンズ押出部材を挿入する工程と、筒状部材に、眼内レンズ押出部材を挿入する工程と、筒状部材に、流体供給手段を設ける工程を有する製造方法でもよい。 Further, a manufacturing method of the intraocular lens insertion device of the present disclosure is a manufacturing method for the above intraocular lens insertion device, the step of inserting an intraocular lens extrusion member into the device body, and an intraocular lens extrusion member After the step of inserting, there is a step of fixing the cylindrical member provided with the fluid supply means and the moving member to the instrument body. Alternatively, as another manufacturing method, after the step of inserting the intraocular lens pushing member into the cylindrical member provided with the fluid supply means and the moving member and the step of inserting the intraocular lens pushing member, The manufacturing method may include a step of fixing the instrument body. Alternatively, as yet another manufacturing method, a step of inserting an intraocular lens extruding member into a cylindrical member formed integrally with the instrument body in advance, a step of inserting an intraocular lens extruding member into the cylindrical member, A manufacturing method including a step of providing fluid supply means on the cylindrical member may be used.
 なお、上記3例のような製造方法で製造された本件開示の眼内レンズ挿入器具は、挿入器具のみの商品として製造場所から出荷して市場に流通させてもよいし、製造場所において、あらかじめ眼内レンズが眼内レンズ挿入器具に収納されて、挿入器具とレンズが一体となった商品、いわゆるプリロード型(プリセット型)の商品として製造場所から出荷して市場に流通させてもよい。 The intraocular lens insertion device of the present disclosure manufactured by the manufacturing method as in the above three examples may be shipped from the manufacturing site as a product only for the insertion device and distributed to the market. The intraocular lens may be housed in an intraocular lens insertion device, and the product may be shipped from the manufacturing site and distributed to the market as a product in which the insertion device and the lens are integrated, ie, a so-called preload type (preset type) product.
 本件開示の技術によれば、プランジャーの操作性を向上させる眼内レンズ挿入器具を提供することができる。 According to the technique disclosed herein, an intraocular lens insertion device that improves the operability of the plunger can be provided.
一実施形態における眼内レンズ挿入器具の概略構成を示す図である。It is a figure which shows schematic structure of the intraocular lens insertion instrument in one Embodiment. 一実施形態における眼内レンズの概略構成を示す図である。It is a figure which shows schematic structure of the intraocular lens in one Embodiment. 一実施形態におけるノズル本体の概略構成を示す図である。It is a figure which shows schematic structure of the nozzle main body in one Embodiment. 一実施形態における位置決め部材の概略構成を示す図である。It is a figure which shows schematic structure of the positioning member in one Embodiment. 一実施形態におけるプランジャーの概略構成を示す図である。It is a figure which shows schematic structure of the plunger in one Embodiment. 図6(a)および図6(b)は、一実施形態における眼内レンズ挿入器具のプランジャーの移動を例示する図である。FIG. 6A and FIG. 6B are diagrams illustrating the movement of the plunger of the intraocular lens insertion device in one embodiment. 図7(a)および図7(b)は、一実施形態における眼内レンズ挿入器具の製造方法を示す図である。Fig.7 (a) and FIG.7 (b) are figures which show the manufacturing method of the intraocular lens insertion instrument in one Embodiment. 図8(a)および図8(b)は、一変形例における眼内レンズ挿入器具の製造方法を示す図である。FIG. 8A and FIG. 8B are diagrams showing a method for manufacturing an intraocular lens insertion device in one modification. 図9(a)および図9(b)は、一変形例における眼内レンズ挿入器具の製造方法を示す図である。FIG. 9A and FIG. 9B are diagrams showing a method for manufacturing an intraocular lens insertion device in one modification. 図10(a)および図10(b)は、一変形例における眼内レンズ挿入器具の概略構成を示す図である。FIG. 10A and FIG. 10B are diagrams showing a schematic configuration of an intraocular lens insertion device according to a modification. 図11は、一変形例における眼内レンズ挿入器具の概略構成を示す図である。FIG. 11 is a diagram illustrating a schematic configuration of an intraocular lens insertion device according to a modification. 図12は、一変形例における眼内レンズ挿入器具の概略構成を示す図である。FIG. 12 is a diagram illustrating a schematic configuration of an intraocular lens insertion device according to a modification.
 以下に、図面を参照して本発明の実施の形態について説明する。 Hereinafter, embodiments of the present invention will be described with reference to the drawings.
 〔実施例〕
 図1に、本実施形態の眼内レンズ挿入器具1の概略構成を示す。図1(a)はステージ蓋部13を開蓋した場合の眼内レンズ挿入器具1の平面図、図1(b)はステージ蓋部13を閉蓋した場合の眼内レンズ挿入器具1の側面図を示している。眼内レンズ挿入器具1は、器具本体としてのノズル本体10と、眼内レンズの押出部材としてのプランジャー30と、眼内レンズの収納部としてのステージ部12及びステージ蓋部13と、眼内レンズの押し出しを補助する眼内レンズ押出補助具20とを有する。ステージ部12は、ノズル本体10に一体又は別体に設けられる。ノズル本体10にはプランジャー30が挿入されている。ステージ部12には、眼内レンズ2がセットされる。ステージ蓋部13は、ステージ部12と一体に形成されている。眼内レンズ押出補助具20は、中空の円筒部材であり、その一端がノズル本体10のホールド部11と係合している。なお、眼内レンズ押出補助具20の形状は円筒に限らず任意の形状で成形することができる。
〔Example〕
In FIG. 1, schematic structure of the intraocular lens insertion instrument 1 of this embodiment is shown. 1A is a plan view of the intraocular lens insertion instrument 1 when the stage lid 13 is opened, and FIG. 1B is a side view of the intraocular lens insertion instrument 1 when the stage lid 13 is closed. The figure is shown. The intraocular lens insertion instrument 1 includes a nozzle body 10 as an instrument body, a plunger 30 as an intraocular lens pushing member, a stage unit 12 and a stage lid unit 13 as an intraocular lens storage unit, And an intraocular lens push-out assisting tool 20 that assists in pushing out the lens. The stage unit 12 is provided integrally with the nozzle body 10 or separately. A plunger 30 is inserted into the nozzle body 10. The intraocular lens 2 is set on the stage unit 12. The stage lid portion 13 is formed integrally with the stage portion 12. The intraocular lens extrusion assisting tool 20 is a hollow cylindrical member, and one end thereof is engaged with the holding portion 11 of the nozzle body 10. In addition, the shape of the intraocular lens extrusion assisting tool 20 is not limited to a cylinder, and can be formed in an arbitrary shape.
 眼内レンズ挿入器具1のノズル本体10は、断面略矩形の筒状に形成されており片側の端部は大きく開口し(以下、大きく開口した側を後端部10bという。)、別の側の端部には細く絞られたノズル部15と先端部10aを備える。図1(b)に示すように、先端部10aは斜めに開口している。プランジャー30は、ノズル本体10に挿入され往復運動可能である。 The nozzle main body 10 of the intraocular lens insertion device 1 is formed in a cylindrical shape having a substantially rectangular cross section, and one end of the nozzle body 10 is greatly open (hereinafter, the side having the large opening is referred to as the rear end 10b), and the other side. The nozzle part 15 and the front-end | tip part 10a narrowed down are provided in the edge part. As shown in FIG.1 (b), the front-end | tip part 10a is opening diagonally. The plunger 30 is inserted into the nozzle body 10 and can reciprocate.
 以下の説明において、ノズル本体10の後端部10bから先端部10aへ向かう方向を前方向、その逆方向を後方向、図1(a)において紙面手前側を上方向、その逆方向を下方向、図1(b)において紙面手前方向を左方向、その逆方向を右方向とする。また、この場合、上側は後述するレンズ本体2aの光軸前側に、下側はレンズ本体2aの光軸後側に、前側はプランジャー30による押圧方向前側に、後側はプランジャー30による押圧方向後側に相当する。 In the following description, the direction from the rear end 10b of the nozzle body 10 to the front end 10a is the front direction, the opposite direction is the rear direction, the front side of the page in FIG. 1A is the upper direction, and the reverse direction is the lower direction. In FIG. 1B, the front side of the page is the left direction, and the opposite direction is the right direction. In this case, the upper side is the front side of the optical axis of the lens body 2a, which will be described later, the lower side is the rear side of the optical axis of the lens body 2a, the front side is the front side in the pressing direction by the plunger 30, and the rear side is pressed by the plunger 30 Corresponds to the rear side.
 ノズル本体10の後端部10b付近には、板状に迫り出し、使用者がプランジャー30をノズル本体10の先端側に押し込む際に指を掛けることが可能なホールド部11が一体的に設けられている。また、ノズル本体10におけるノズル部15の後側には、眼内レンズ2をセットするステージ部12が設けられている。このステージ部12は、ステージ蓋部13を開蓋することでノズル本体10の上側が開放されるようになっている。また、ステージ部12には、ノズル本体10の下側から位置決め部材50が取り付けられている。この位置決め部材50によって、使用前(輸送中)においてもステージ部12内で眼内レンズ2が安定して保持されている。 In the vicinity of the rear end portion 10b of the nozzle body 10, there is integrally provided a holding portion 11 that protrudes like a plate and can be hooked by the user when the plunger 30 is pushed into the front end side of the nozzle body 10. It has been. A stage portion 12 for setting the intraocular lens 2 is provided on the rear side of the nozzle portion 15 in the nozzle body 10. The stage portion 12 is configured such that the upper side of the nozzle body 10 is opened by opening the stage lid portion 13. Further, a positioning member 50 is attached to the stage portion 12 from the lower side of the nozzle body 10. By this positioning member 50, the intraocular lens 2 is stably held in the stage portion 12 even before use (during transportation).
 すなわち、眼内レンズ挿入器具1においては、製造時に、ステージ蓋部13が開蓋し位置決め部材50がステージ部12に取り付けられた状態で、眼内レンズ2がステージ部12に、光軸前側が上になるようにセットされる。そして、ステージ蓋部13を閉蓋させた後出荷され、販売される。そして、使用者はステージ蓋部13を閉蓋したままで位置決め部材50を取り外し、その後プランジャー30をノズル本体10の先端側に押し込む。これにより、プランジャー30によって眼内レンズ2を押圧し、ノズル部15まで移動させた上で、先端部10aより眼内レンズ2を眼球内に放出する。なお、眼内レンズ挿入器具1におけるノズル本体10、プランジャー30、位置決め部材50はポリプロピレンなどの樹脂の素材で形成される。ポリプロピレンは医療用機器において実績があり、耐薬品性などの信頼性も高い素材である。 That is, in the intraocular lens insertion instrument 1, the intraocular lens 2 is placed on the stage unit 12 and the front side of the optical axis is in a state where the stage lid unit 13 is opened and the positioning member 50 is attached to the stage unit 12. Set to be on top. Then, after the stage lid 13 is closed, it is shipped and sold. Then, the user removes the positioning member 50 with the stage lid portion 13 closed, and then pushes the plunger 30 into the distal end side of the nozzle body 10. As a result, the intraocular lens 2 is pressed by the plunger 30 and moved to the nozzle part 15, and then the intraocular lens 2 is released into the eyeball from the distal end part 10 a. In addition, the nozzle main body 10, the plunger 30, and the positioning member 50 in the intraocular lens insertion device 1 are formed of a resin material such as polypropylene. Polypropylene is a material with a proven track record in medical equipment and high reliability such as chemical resistance.
 眼内レンズ押出補助具20は、ノズル本体10に挿入されたプランジャー30の延伸方向に延びる円筒形状の筒状部材20aを有する。また、筒状部材20aの側面には、筒状部材20aを貫通する貫通孔20bが設けられている。また、筒状部材20aの後端側には、移動部材としてのパッキン20cが、筒状部材20aの内壁と当接するように設けられている。パッキン20cは、筒状部材20aの内壁に密接しつつ内壁を摺動可能に設けられている。なお、パッキン20cは摺動する際に撓むことのない程度の剛性を有することが望ましい。ただし、パッキン20cがそのような剛性を有しない場合でも、押圧板部33の外径L2をパッキン20cの内径と同程度にすれば、パッキン20cが摺動時に撓むことを防止することができる。さらに、筒状部材20aの内径L1に対してパッキン20cの直径が大きいと、パッキン20cの摺動時のパッキン20cに対する押出し荷重が大きくなり、そこからパッキン20cの直径が内径L1に近づくにつれて当該押出し荷重は小さくなる。さらに、眼内レンズ押出補助具20の後端には、眼内レンズ押出補助具20とパッキン20cとで囲まれる空間に流体を供給するための流体供給手段としての流体供給部20dが設けられている。 The intraocular lens extrusion assisting tool 20 has a cylindrical tubular member 20 a extending in the extending direction of the plunger 30 inserted into the nozzle body 10. Moreover, the through-hole 20b which penetrates the cylindrical member 20a is provided in the side surface of the cylindrical member 20a. A packing 20c as a moving member is provided on the rear end side of the cylindrical member 20a so as to contact the inner wall of the cylindrical member 20a. The packing 20c is slidably provided on the inner wall while being in close contact with the inner wall of the cylindrical member 20a. It is desirable that the packing 20c has a rigidity that does not bend when sliding. However, even when the packing 20c does not have such rigidity, if the outer diameter L2 of the pressing plate portion 33 is set to be approximately equal to the inner diameter of the packing 20c, the packing 20c can be prevented from being bent during sliding. . Furthermore, if the diameter of the packing 20c is larger than the inner diameter L1 of the cylindrical member 20a, the pushing load on the packing 20c when the packing 20c is slid increases, and from there, the pushing out as the diameter of the packing 20c approaches the inner diameter L1. The load becomes smaller. Furthermore, the rear end of the intraocular lens extrusion assisting tool 20 is provided with a fluid supply unit 20d as a fluid supply means for supplying a fluid to a space surrounded by the intraocular lens extrusion assisting tool 20 and the packing 20c. Yes.
 また、筒状部材20aとパッキン20cと流体供給部20dとで囲まれる領域は、密閉空間となっている。なお、筒状部材20aにより囲まれる空間のうち、パッキン20cを境界として、流体供給部20d側の領域を第1の領域20fとし、ノズル本体10に挿入されたプランジャー30側の領域を第2の領域20gとする。また、貫通孔20bは、第1の領域20fに供給された流体を眼内レンズ押出補助具20の外部へ流出させる機能を有する。 Further, a region surrounded by the cylindrical member 20a, the packing 20c, and the fluid supply unit 20d is a sealed space. Of the space surrounded by the cylindrical member 20a, the region on the fluid supply part 20d side is defined as the first region 20f with the packing 20c as a boundary, and the region on the plunger 30 side inserted into the nozzle body 10 is defined as the second region. The region 20g. The through-hole 20b has a function of causing the fluid supplied to the first region 20f to flow out of the intraocular lens push-out assisting tool 20.
 さらに眼内レンズ押出補助具20の先端側にはノズル本体10のホールド部11と係合するための係合部20hが設けられている。図1(b)に示すように、本実施形態ではノズル本体10のホールド部11が上下方向に延伸しているため、係合部20hは、ノズル本体10に取り受けられた状態の眼内レンズ押出補助具20において上下方向に一対設けられている。また、各係合部20hには、ホールド部11の一部が貫通する貫通孔20iが設けられている。 Furthermore, an engagement portion 20 h for engaging with the hold portion 11 of the nozzle body 10 is provided on the distal end side of the intraocular lens push-out assisting tool 20. As shown in FIG. 1B, in this embodiment, since the holding portion 11 of the nozzle body 10 extends in the vertical direction, the engaging portion 20h is an intraocular lens in a state of being received by the nozzle body 10. A pair of extrusion assisting tools 20 are provided in the vertical direction. Each engagement portion 20h is provided with a through hole 20i through which a part of the hold portion 11 passes.
 眼内レンズ押出補助具20がノズル本体10に取り付けられる場合は、係合部20hの貫通孔20iにノズル本体10のホールド部11の両端がそれぞれ挿し通される。また、ホールド部11の両端にはノッチ11aが設けられている。このため、眼内レンズ押出補助具20の係合部20hがホールド部11に一度取り付けられると、係合部20hとホールド部11との係合はノッチ11aによって解除されない。なお、係合部20hとホールド部11との係合が解除されない構成であれば、ノッチはホールド部11の代わりにあるいはホールド部11に加えて係合部20hに設けてもよい。なお、眼内レンズ押出補助具20をノズル本体10に取り付けられる際は、第2の領域20gが密閉空間にならないように、眼内レンズ押出補助具20とノズル本体10の接続箇所に少なくとも1つの開口構造を設ける必要がある。なぜならば、眼内レンズ押出補助具20とノズル本体10の取付前に第2の領域20gに存在する空気を、パッキン20cが移動するに伴い、外部に排出させる必要があるためである。 When the intraocular lens push-out assisting tool 20 is attached to the nozzle body 10, both ends of the hold part 11 of the nozzle body 10 are inserted through the through holes 20i of the engaging part 20h. Further, notches 11 a are provided at both ends of the hold unit 11. For this reason, once the engaging part 20h of the intraocular lens pushing auxiliary tool 20 is attached to the hold part 11, the engagement between the engaging part 20h and the hold part 11 is not released by the notch 11a. Note that the notch may be provided in the engaging portion 20h instead of the holding portion 11 or in addition to the holding portion 11 as long as the engaging portion 20h and the holding portion 11 are not disengaged. When the intraocular lens extrusion assisting tool 20 is attached to the nozzle main body 10, at least one of the intraocular lens extrusion assisting tool 20 and the nozzle main body 10 is connected so that the second region 20 g does not become a sealed space. It is necessary to provide an opening structure. This is because the air existing in the second region 20g before the attachment of the intraocular lens pushing aid 20 and the nozzle body 10 needs to be discharged to the outside as the packing 20c moves.
 流体供給部20dの後側の端面には、チューブ40から供給される流体が通過する開口20eが設けられている。また、流体供給部20dは、前側が筒状部材20aの後端と接続されており、後側がチューブ40の先端と接続可能である。筒状部材20aの内径L1は、プランジャー30の押圧板部33の外径L2よりも大きくなるように設けられている。なお、供給される流体の単位時間あたりの流入量が一定である場合、筒状部材20aの内径L1が大きくなるにつれてパッキン20cおよびプランジャー30の押し出し速度は遅くなるが、より強い押し出し力による安定した押し出しが可能になる。一方、流体供給部20dの開口20eの開口径L3は、筒状部材20aの内径L1よりも小さくなるように設けられている。そして、開口20eは、一般の医療用チューブの内径または外径と係合可能な寸法とされている。もしくは、開口20eとチューブ40とをコネクタを介して接続してもよい。流体供給部20dには、汎用性の高い医療用チューブを接続でき、特別なチューブを用意する必要がないようになっている。また、流体供給部20dに接続されるチューブ40の他端には、第1の領域20f内に流体を供給するための流体供給源(図示せず)が接続される。なお、流体供給源の例としては、圧縮空気を供給するためのコンプレッサーや冷温水を供給するためのポンプなどが挙げられる。 An opening 20e through which the fluid supplied from the tube 40 passes is provided on the rear end face of the fluid supply unit 20d. The fluid supply unit 20d has a front side connected to the rear end of the cylindrical member 20a and a rear side connectable to the tip of the tube 40. An inner diameter L1 of the cylindrical member 20a is provided to be larger than an outer diameter L2 of the pressing plate portion 33 of the plunger 30. In addition, when the inflow amount per unit time of the fluid to be supplied is constant, the pushing speed of the packing 20c and the plunger 30 becomes slower as the inner diameter L1 of the cylindrical member 20a becomes larger, but the stability by the stronger pushing force is increased. Extrusion is possible. On the other hand, the opening diameter L3 of the opening 20e of the fluid supply unit 20d is provided to be smaller than the inner diameter L1 of the cylindrical member 20a. And the opening 20e is made into the dimension which can be engaged with the internal diameter or outer diameter of a general medical tube. Alternatively, the opening 20e and the tube 40 may be connected via a connector. A highly versatile medical tube can be connected to the fluid supply unit 20d, and it is not necessary to prepare a special tube. In addition, a fluid supply source (not shown) for supplying fluid into the first region 20f is connected to the other end of the tube 40 connected to the fluid supply unit 20d. Examples of the fluid supply source include a compressor for supplying compressed air and a pump for supplying cold / hot water.
 図2は、眼内レンズ2の概略構成を示した図である。図2(a)は平面図、図2(b)は側面図を示す。眼内レンズ2は、いわゆるスリーピース型である。眼内レンズ2は、所定の屈折力を有するレンズ本体2aと、レンズ本体2aに連結された、レンズ本体2aを眼球内で保持するためのヒゲ状の2本の支持部2b、2bとから形成されている。レンズ本体2a及び支持部2bは可撓性の樹脂材料から形成されている。本実施例における眼内レンズ挿入器具1内では、2つの支持部2b、2bのうちの一つが、レンズ本体2aの後側、もう一つがレンズ本体の前側に配置されるように、眼内レンズ2がセットされる。 FIG. 2 is a diagram showing a schematic configuration of the intraocular lens 2. 2A is a plan view and FIG. 2B is a side view. The intraocular lens 2 is a so-called three-piece type. The intraocular lens 2 is formed of a lens body 2a having a predetermined refractive power and two beard-shaped support portions 2b, 2b connected to the lens body 2a for holding the lens body 2a in the eyeball. Has been. The lens body 2a and the support portion 2b are made of a flexible resin material. In the intraocular lens insertion device 1 in the present embodiment, the intraocular lens is arranged such that one of the two support portions 2b and 2b is disposed on the rear side of the lens body 2a and the other is disposed on the front side of the lens body. 2 is set.
 図3にはノズル本体10の平面図を示す。前述のようにノズル本体10においては、眼内レンズ2はステージ部12にセットされる。そして、その状態でプランジャー30によって眼内レンズ2が押圧されて先端部10aから放出される。なお、ノズル本体10の内部にはノズル本体10の外形の変化に応じて断面形状が変化する貫通孔10cが設けられている。そして、眼内レンズ2が放出される際は、眼内レンズ2は、ノズル本体10内の貫通孔10cの断面形状の変化に応じて変形して折り畳まれた状態となり、患者の眼球に形成された切開創に入り易い形に変形した上で放出される。 FIG. 3 shows a plan view of the nozzle body 10. As described above, in the nozzle body 10, the intraocular lens 2 is set on the stage unit 12. In this state, the intraocular lens 2 is pressed by the plunger 30 and is released from the distal end portion 10a. In addition, a through hole 10 c whose cross-sectional shape changes according to a change in the outer shape of the nozzle body 10 is provided in the nozzle body 10. When the intraocular lens 2 is released, the intraocular lens 2 is deformed and folded according to a change in the cross-sectional shape of the through hole 10c in the nozzle body 10, and is formed on the patient's eyeball. It is released after being transformed into a shape that is easy to enter an incision.
 また、先端部10aは、ノズル部15の上側の領域が下側の領域より前側になるように斜めにカットされた形状となっている。なお、この先端部10aの斜めにカットされた形状については、左右方向から見て直線的に斜めにカットされていてもよいし、外側に膨らみを持つように、すなわち曲面形状となるように斜めにカットされていてもよい。 Further, the tip portion 10a has a shape cut obliquely so that the upper region of the nozzle portion 15 is in front of the lower region. Note that the shape of the tip portion 10a that is obliquely cut may be linearly obliquely cut when viewed from the left-right direction, or may have a bulge outward, that is, a curved shape. It may be cut into
 ステージ部12には、眼内レンズ2のレンズ本体2aの径より僅かに大きな幅を有するステージ溝12aが形成されている。ステージ溝12aの前後方向の寸法は、眼内レンズ2の両側に延びる支持部2b、2bを含む最大幅寸法よりも大きく設定されている。また、ステージ溝12aの底面によってセット面12bが形成されている。セット面12bの上下方向位置は、ノズル本体10の貫通孔10cの底面の高さ位置よりも上方に設定されており、セット面12bと貫通孔10cの底面とは底部斜面10dによって連結されている。 A stage groove 12 a having a width slightly larger than the diameter of the lens body 2 a of the intraocular lens 2 is formed in the stage portion 12. The dimension in the front-rear direction of the stage groove 12 a is set to be larger than the maximum width dimension including the support portions 2 b and 2 b extending on both sides of the intraocular lens 2. A set surface 12b is formed by the bottom surface of the stage groove 12a. The vertical position of the set surface 12b is set higher than the height position of the bottom surface of the through hole 10c of the nozzle body 10, and the set surface 12b and the bottom surface of the through hole 10c are connected by a bottom slope 10d. .
 ステージ部12とステージ蓋部13とは一体に形成されている。ステージ蓋部13はステージ部12と同等の前後方向の寸法を有している。ステージ蓋部13は、ステージ部12の側面がステージ蓋部13側に延出して形成された薄板状の連結部14によって連結されている。連結部14は中央部で屈曲可能に形成されており、ステージ蓋部13は、連結部14を屈曲させることでステージ部12に上側から重なり閉蓋することができる。 The stage portion 12 and the stage lid portion 13 are integrally formed. The stage lid portion 13 has the same size in the front-rear direction as the stage portion 12. The stage lid portion 13 is connected by a thin plate-like connecting portion 14 formed by extending the side surface of the stage portion 12 to the stage lid portion 13 side. The connecting portion 14 is formed to be bendable at the center portion, and the stage lid portion 13 can be closed by overlapping the stage portion 12 from above by bending the connecting portion 14.
 ステージ蓋部13において、閉蓋時にセット面12bと対向する面には、ステージ蓋部13を補強し、眼内レンズ2の位置を安定させるためにリブ13a及び13bが設けられている。また、プランジャー30の上側のガイドとして案内突起13cが設けられている。また、ステージ蓋部13には眼内レンズのノズル内の移動をスムーズにするための粘弾性物質を注入する注入穴16が設けられている。ステージ蓋部13の外側には、注入穴16の外周の一部が盛り上がっている突起部17が設けられている。突起部17は、注入される注射器の針を注入穴16にガイドして粘弾性物質を注入しやすくする機能を有する。 In the stage lid 13, ribs 13 a and 13 b are provided on the surface facing the set surface 12 b when the lid is closed in order to reinforce the stage lid 13 and stabilize the position of the intraocular lens 2. Further, a guide protrusion 13 c is provided as a guide on the upper side of the plunger 30. The stage lid 13 is provided with an injection hole 16 for injecting a viscoelastic material for smooth movement of the intraocular lens in the nozzle. On the outside of the stage lid portion 13, there is provided a projection portion 17 in which a part of the outer periphery of the injection hole 16 is raised. The protrusion 17 has a function of making it easier to inject the viscoelastic material by guiding the needle of the syringe to be injected into the injection hole 16.
 ステージ部12のセット面12bの下側には、位置決め部材50が取外し可能に設けられている。図4に、位置決め部材50の概略構成を示す。図4(a)は位置決め部材50の平面図を示し、図4(b)は位置決め部材50の左側面図を示している。位置決め部材50はノズル本体10と別体として構成されており、一対の側壁部51、51が連結部52で連結された構造とされている。それぞれの側壁部51の下端には、外側に向けて延出して広がる保持部53、53が形成されている。 A positioning member 50 is detachably provided below the set surface 12b of the stage portion 12. FIG. 4 shows a schematic configuration of the positioning member 50. FIG. 4A shows a plan view of the positioning member 50, and FIG. 4B shows a left side view of the positioning member 50. The positioning member 50 is configured as a separate body from the nozzle main body 10, and has a structure in which a pair of side wall portions 51, 51 are connected by a connecting portion 52. At the lower ends of the respective side wall portions 51, holding portions 53, 53 extending outward and extending are formed.
 そして、それぞれの側壁部51、51の上端部には、上側に突出した一対の第1載置部54、54が形成されている。さらに、第1載置部54、54の上端面における外周側には、第1位置決め部55、55が突出して形成されている。第1位置決め部55、55の内側どうしの離隔長さは、眼内レンズ2のレンズ本体2aの径寸法よりも僅かに大きく設定されている。 A pair of first mounting portions 54 and 54 protruding upward are formed at the upper end portions of the side wall portions 51 and 51, respectively. Further, first positioning portions 55 and 55 are formed to protrude from the outer peripheral side of the upper end surfaces of the first placement portions 54 and 54. The distance between the inner sides of the first positioning portions 55 and 55 is set slightly larger than the diameter of the lens body 2 a of the intraocular lens 2.
 また、側壁部51、51の内側の前後方向の両端には、上側に突出した一対の第2載置部56、56が形成されている。第2載置部56、56の上面の高さは、第1載置部54、54の上面の高さと同等になっている。さらに、第2載置部56、56の上面において外側の部分には、第2載置部56、56の左右方向の全体にわたって上側にさらに突出する第2位置決め部57、57が形成されている。第2位置決め部57、57の内側どうしの離隔長さは、眼内レンズ2のレンズ本体2aの径寸法よりも僅かに大きく設定されている。加えて、第2載置部56、56の上端部には左右方向の全体にわたり、前後方向に僅かに突出した係止爪58、58が形成されている。 Also, a pair of second mounting portions 56 and 56 projecting upward are formed at both ends in the front-rear direction inside the side wall portions 51 and 51. The heights of the upper surfaces of the second mounting parts 56 and 56 are equal to the heights of the upper surfaces of the first mounting parts 54 and 54. Furthermore, second positioning portions 57 and 57 that protrude further upward are formed on the outer portions of the upper surfaces of the second placement portions 56 and 56 over the entire left and right direction of the second placement portions 56 and 56. . The distance between the inner sides of the second positioning portions 57 and 57 is set to be slightly larger than the diameter dimension of the lens body 2 a of the intraocular lens 2. In addition, locking claws 58, 58 that slightly protrude in the front-rear direction are formed on the upper ends of the second placement portions 56, 56 over the entire left-right direction.
 上記の位置決め部材50は、ノズル本体10のセット面12bの下側から組み付けられる。ノズル本体10のセット面12bには、厚さ方向にセット面12bを貫通するセット面貫通孔12cが形成されている。セット面貫通孔12cの外形は、位置決め部材50の第1載置部54、54及び第2載置部56、56を上側から見た形状に対し僅かに大きな略相似形状とされている。そして、位置決め部材50がノズル本体10に取り付けられる際には、第1載置部54、54及び第2載置部56、56が、セット面12bの下側からセット面貫通孔12cに挿入され、セット面12bの上側に突出する。 The positioning member 50 is assembled from below the set surface 12b of the nozzle body 10. The set surface 12b of the nozzle body 10 is formed with a set surface through hole 12c that penetrates the set surface 12b in the thickness direction. The outer shape of the set surface through-hole 12c is a substantially similar shape that is slightly larger than the shape of the first placement portions 54 and 54 and the second placement portions 56 and 56 of the positioning member 50 as viewed from above. When the positioning member 50 is attached to the nozzle body 10, the first placement portions 54 and 54 and the second placement portions 56 and 56 are inserted into the set surface through hole 12c from the lower side of the set surface 12b. , Protruding above the set surface 12b.
 その際、第2位置決め部57、57に設けられた係止爪58、58がセット面貫通孔12cを介してセット面12bに突出し、セット面12bの上面に係止される。このことによって、位置決め部材50がノズル本体10の下側から組み付けられ、第1載置部54、54及び第2載置部56、56がセット面12bから突出した状態で固定される。そして、眼内レンズ2がセット面12bにセットされる際には、レンズ本体2aの外周部底面が、第1載置部54、54及び第2載置部56、56の上面に載置される。また、レンズ本体2aは第1位置決め部55、55及び第2位置決め部57、57によって水平方向(セット面12bに水平な方向)に対して位置規制される。 At that time, the locking claws 58, 58 provided in the second positioning portions 57, 57 protrude through the set surface through hole 12c to the set surface 12b and are locked to the upper surface of the set surface 12b. Accordingly, the positioning member 50 is assembled from the lower side of the nozzle body 10, and the first placement portions 54 and 54 and the second placement portions 56 and 56 are fixed in a state of protruding from the set surface 12b. When the intraocular lens 2 is set on the setting surface 12b, the bottom surface of the outer peripheral portion of the lens body 2a is placed on the upper surfaces of the first placement portions 54 and 54 and the second placement portions 56 and 56. The Further, the position of the lens body 2a is restricted with respect to the horizontal direction (the direction horizontal to the set surface 12b) by the first positioning portions 55, 55 and the second positioning portions 57, 57.
 眼内レンズ2を眼球内に挿入する際は、粘弾性物質を注入穴16から適量注入した後に位置決め部材50をノズル本体10から取り外す。これにより、眼内レンズ2のレンズ本体2aを支持していた第1載置部54、54および第2載置部56、56がセット面12bから後退し、眼内レンズ2がセット面12b上に移動可能に載置される。 When inserting the intraocular lens 2 into the eyeball, the positioning member 50 is removed from the nozzle body 10 after an appropriate amount of viscoelastic material is injected from the injection hole 16. As a result, the first placement portions 54 and 54 and the second placement portions 56 and 56 that have supported the lens body 2a of the intraocular lens 2 are retracted from the set surface 12b, and the intraocular lens 2 is on the set surface 12b. Is movably mounted.
 続いて、眼組織に設けた切開創に、ノズル本体10のノズル部15における先端部10aを挿入する。ここにおいて、先端部10aは斜めの開口形状を有しているので、切開創への挿入を容易に行なうことができる。そして、切開創にノズル部15を挿入した後に、プランジャー30の押圧板部33をノズル本体10の先端側に押し込む。これにより、セット面12aにセットされた眼内レンズ2のレンズ本体2a外周にプランジャー30の作用部31の先端部31cが当接し、プランジャー30によって眼内レンズ2が先端部10aに向けて案内される。 Subsequently, the distal end portion 10a of the nozzle portion 15 of the nozzle body 10 is inserted into the incision provided in the eye tissue. Here, since the distal end portion 10a has an oblique opening shape, it can be easily inserted into the incision. Then, after inserting the nozzle portion 15 into the incision, the pressing plate portion 33 of the plunger 30 is pushed into the distal end side of the nozzle body 10. Thereby, the front-end | tip part 31c of the action part 31 of the plunger 30 contact | abuts to the lens main body 2a outer periphery of the intraocular lens 2 set to the setting surface 12a, and the intraocular lens 2 faces the front-end | tip part 10a with the plunger 30. Guided.
 次に、図5(a)および図5(b)に、プランジャー30の概略構成を示す。プランジャー30は、ノズル本体10よりもやや大きな前後方向長さを有している。そして、円柱形状を基本とした先端側の作用部31と、矩形ロッド形状を基本とした後端側の挿通部32とから形成されている。そして、作用部31は、円柱形状とされた円柱部31aと、円柱部31aの左右方向に広がる薄板状の扁平部31bとを含んで構成されている。 Next, a schematic configuration of the plunger 30 is shown in FIGS. 5 (a) and 5 (b). The plunger 30 has a slightly larger longitudinal length than the nozzle body 10. And it forms from the action part 31 of the front end side based on a column shape, and the insertion part 32 of the rear end side based on a rectangular rod shape. And the action part 31 is comprised including the cylindrical part 31a made into the column shape, and the thin plate-shaped flat part 31b extended in the left-right direction of the cylindrical part 31a.
 作用部31の先端部分には、切欠部31cが形成されている。この切欠部31cは、図5(a)に示すように、作用部31の上方向に開口し左右方向に貫通する溝状に形成されている。また、図5(b)に示すように、切欠部31cの先端側の溝壁は作用部31の先端側に行くに連れて上方に向かう傾斜面で形成されている。一方、挿通部32は、全体的に概略H字状の断面を有しており、その左右方向及び上下方向の寸法は、ノズル本体10の貫通孔10cよりも僅かに小さく設定されている。また、挿通部32の後端には、上下左右方向に広がる円板状の押圧板部33が形成されている。 A notch 31 c is formed at the tip of the action part 31. As shown in FIG. 5A, the notch 31c is formed in a groove shape that opens upward in the action portion 31 and penetrates in the left-right direction. Further, as shown in FIG. 5B, the groove wall on the distal end side of the notch 31 c is formed with an inclined surface that goes upward as it goes to the distal end side of the action portion 31. On the other hand, the insertion part 32 has a substantially H-shaped cross section as a whole, and the horizontal and vertical dimensions thereof are set slightly smaller than the through hole 10 c of the nozzle body 10. In addition, a disc-shaped pressing plate portion 33 is formed at the rear end of the insertion portion 32 so as to spread in the vertical and horizontal directions.
 挿通部32の前後方向の中央より先側の部分には、挿通部32の上側に向けて突出し、プランジャー30の素材の弾性により上下に移動可能な爪部32aが形成されている。そして、プランジャー30がノズル本体10に挿入された際には、ノズル本体10の上面において厚さ方向に設けられた図3に示す係止孔10eと爪部32aが係合し、このことにより初期状態におけるノズル本体10とプランジャー30との相対位置が決定される。なお、爪部32aと係止孔10eの形成位置は、係合状態において、作用部31の先端が、ステージ部12にセットされた眼内レンズ2のレンズ本体2aの後側に位置し、レンズ本体2aの後側の支持部2bを切欠部31cが下方から支持可能な場所に位置するよう設定されている。 A claw portion 32 a that protrudes upward from the insertion portion 32 and that can move up and down by the elasticity of the material of the plunger 30 is formed at a portion of the insertion portion 32 that is ahead of the center in the front-rear direction. When the plunger 30 is inserted into the nozzle body 10, the locking hole 10e shown in FIG. 3 provided in the thickness direction on the upper surface of the nozzle body 10 and the claw portion 32a are engaged. The relative position between the nozzle body 10 and the plunger 30 in the initial state is determined. It should be noted that the claw portion 32a and the locking hole 10e are formed at the positions where the distal end of the action portion 31 is located on the rear side of the lens body 2a of the intraocular lens 2 set on the stage portion 12 in the engaged state. The support portion 2b on the rear side of the main body 2a is set so that the cutout portion 31c can be supported from below.
 上記のように構成された眼内レンズ挿入器具1の眼内レンズ2の収納前においては、プランジャー30がノズル本体10に挿入されて初期位置に配置される。また、上記の通り、位置決め部材50が、セット面12bの下方からノズル本体10に取り付けられる。これにより、位置決め部材50の第1載置部54及び第2載置部56がセット面12bに突出した状態に保持される。 Prior to the accommodation of the intraocular lens 2 of the intraocular lens insertion device 1 configured as described above, the plunger 30 is inserted into the nozzle body 10 and disposed at the initial position. Further, as described above, the positioning member 50 is attached to the nozzle body 10 from below the set surface 12b. Thereby, the 1st mounting part 54 and the 2nd mounting part 56 of the positioning member 50 are hold | maintained in the state protruded to the set surface 12b.
 次に、眼内レンズ2のレンズ本体2aが支持部2bをノズル本体10の前後方向に向けた状態で第1載置部54および第2載置部56の上面に載置され位置決めされる。この状態において、眼内レンズ2の後側の支持部2bの一部がプランジャー30の切欠部31cに挟まれ、その底面によって支持された状態となる。 Next, the lens body 2 a of the intraocular lens 2 is placed and positioned on the upper surfaces of the first placement part 54 and the second placement part 56 with the support part 2 b facing the front-rear direction of the nozzle body 10. In this state, a part of the support portion 2b on the rear side of the intraocular lens 2 is sandwiched between the notches 31c of the plunger 30 and is supported by the bottom surface thereof.
 次に、図6に、眼内レンズ2がノズル本体10の先端部10aに移動するときの、プランジャー30とプランジャー押出補助具20のパッキン20cとの位置関係を例示する。本実施形態では、術者は、眼内レンズ挿入器具1に収納された眼内レンズ2をプランジャー30を用いて移動させる場合、チューブ40に接続されている流体供給源を作動させて、一定流量の流体をチューブ40および流体供給部20dを経由して、第1の領域20fに供給する。そして、第1の領域20fは流体で満たされる。 Next, FIG. 6 illustrates the positional relationship between the plunger 30 and the packing 20c of the plunger push-out assisting tool 20 when the intraocular lens 2 moves to the tip 10a of the nozzle body 10. In the present embodiment, when the surgeon moves the intraocular lens 2 housed in the intraocular lens insertion device 1 using the plunger 30, the operator operates the fluid supply source connected to the tube 40 to maintain a constant level. A fluid having a flow rate is supplied to the first region 20f via the tube 40 and the fluid supply unit 20d. The first region 20f is filled with fluid.
 流体がさらに第1の領域20fに供給されると、パッキン20cに作用する圧力が大きくなる。そして、当該圧力に基づくパッキン20cを移動させようとする力がパッキン20cの最大静止摩擦力よりも大きくなると、パッキン20cは前側、すなわちノズル本体10側に移動する。そして、図6(a)に示すように、パッキン20cは、プランジャー30の押圧板部33に当接する。 When the fluid is further supplied to the first region 20f, the pressure acting on the packing 20c increases. And if the force which moves packing 20c based on the said pressure becomes larger than the maximum static frictional force of packing 20c, packing 20c will move to the front side, ie, nozzle body 10 side. As shown in FIG. 6A, the packing 20 c comes into contact with the pressing plate portion 33 of the plunger 30.
 流体がさらに第1の領域20fに供給されると、パッキン20cはノズル本体10側に移動するとともにプランジャー30をノズル本体10側に押圧し移動させる。これにより、眼内レンズ2をノズル本体10の先端部10a側に移動させることができる。その際、プランジャー30の押出し方向の中心とパッキン20cの進行方向の中心が一致することが望ましい。これにより、パッキン20cによるプランジャー30の押し出しがより安定することが期待できる。次に、貫通孔20bの機能について説明する。図6(b)に示すように、パッキン20cが孔20bを超えて移動すると、第1の領域20fに供給される流体が孔20bから流出する。 When the fluid is further supplied to the first region 20f, the packing 20c moves toward the nozzle body 10 and presses the plunger 30 toward the nozzle body 10 to move it. Thereby, the intraocular lens 2 can be moved to the tip portion 10 a side of the nozzle body 10. At that time, it is desirable that the center of the plunger 30 in the pushing direction coincides with the center of the packing 20c in the moving direction. Thereby, it can be expected that the pushing of the plunger 30 by the packing 20c is more stable. Next, the function of the through hole 20b will be described. As shown in FIG. 6B, when the packing 20c moves beyond the hole 20b, the fluid supplied to the first region 20f flows out from the hole 20b.
 ここで、例えば術者が意図せずに流体供給源を作動させた場合には、孔20bは術者の手などで塞がれていないと考えられる。その場合には、パッキン20cは図6(b)に例示する位置まで移動した後に第1の領域20fに流体が供給されても、流体は孔20bから筒状部材20aの外に流出する。この結果、それ以上パッキン20cは流体に押されることなく図6(b)に示す位置で停止する。このように、プランジャー押出補助具20に孔20bを設けることにより、流体が第1の領域20fに誤って供給されても、パッキン20cがプランジャー30をノズル本体10の先端部10a側に押し続ける現象を回避することができる。その結果、術者の意図に反して眼内レンズ2がノズル本体10の先端部10aから放出されることを防止できる。 Here, for example, when the operator operates the fluid supply source unintentionally, it is considered that the hole 20b is not blocked by the operator's hand. In that case, even if the fluid is supplied to the first region 20f after the packing 20c has moved to the position illustrated in FIG. 6B, the fluid flows out of the cylindrical member 20a from the hole 20b. As a result, the packing 20c stops at the position shown in FIG. 6B without being pushed by the fluid. In this manner, by providing the hole 20b in the plunger push-out assisting tool 20, even if fluid is erroneously supplied to the first region 20f, the packing 20c pushes the plunger 30 toward the tip 10a side of the nozzle body 10. The continuing phenomenon can be avoided. As a result, it is possible to prevent the intraocular lens 2 from being released from the distal end portion 10a of the nozzle body 10 against the operator's intention.
 一方、術者が意図して流体供給源を作動させた場合には、孔20bは術者の手などで塞がれていると考えられる。その状態でパッキン20cが図6(b)に例示する位置まで移動した後に第1の領域20fに流体が供給されると、流体は孔20bから筒状部材20aの外に流出しない。この結果、流体が第1の領域20fに供給され続けると、パッキン20cは流体に押されて図6(b)に例示する位置からさらにノズル本体の先端部10a側に移動する。そして、プランジャー30はパッキン20cによって押圧移動され、眼内レンズ2をさらにノズル本体10の先端部10a側に移動させる。 On the other hand, when the operator intentionally operates the fluid supply source, the hole 20b is considered to be blocked by the operator's hand. In this state, when the fluid is supplied to the first region 20f after the packing 20c has moved to the position illustrated in FIG. 6B, the fluid does not flow out of the cylindrical member 20a from the hole 20b. As a result, when the fluid continues to be supplied to the first region 20f, the packing 20c is pushed by the fluid and further moves from the position illustrated in FIG. 6B to the tip portion 10a side of the nozzle body. Then, the plunger 30 is pressed and moved by the packing 20c, and further moves the intraocular lens 2 to the tip portion 10a side of the nozzle body 10.
 なお、パッキン20cが図6(b)に例示する位置からさらにノズル本体の先端部10a側に移動する際に、術者は孔20bから指を離すことにより、流体を孔20bから流出させるとともにパッキン20cの移動を中止することができる。したがって、術者は、指などで孔20bを塞いだり、孔20bを塞いでいた指などを孔20から離したりすることで、流体に押されるパッキン20cの移動を制御することができる。これにより、術者はプランジャー30を指で操作する必要がなく、切開創に対するノズル本体10の位置の調整などの他の動作や処置により集中することができる。 When the packing 20c moves further from the position illustrated in FIG. 6B to the tip 10a side of the nozzle body, the operator releases the fluid from the hole 20b and removes the packing by releasing the finger from the hole 20b. The movement of 20c can be stopped. Therefore, the surgeon can control the movement of the packing 20c pushed by the fluid by closing the hole 20b with a finger or the like, or separating the finger or the like that has closed the hole 20b from the hole 20. Thereby, the operator does not need to operate the plunger 30 with a finger, and can concentrate on other operations and treatments such as adjustment of the position of the nozzle body 10 with respect to the incision.
 また、本実施形態では、流体供給源を用いて眼内レンズ押出補助具20に一定流量で流体を供給することにより、パッキン20cの移動ひいてはプランジャー30を一定の速度で移動させることができる。これにより、本実施形態の眼内レンズ挿入器具1によれば、ノズル本体10内において安定した移動速度で眼内レンズ2を移動して眼内に挿入することができる。したがって、従来の眼内レンズ挿入器具に比べて、より安定した眼内レンズの眼内への射出が実現できる。また、眼内レンズの移動が安定することにより、眼球に設けられた切開創への負担も軽減される。 In the present embodiment, the fluid is supplied to the intraocular lens extrusion assisting tool 20 at a constant flow rate using the fluid supply source, so that the movement of the packing 20c and the plunger 30 can be moved at a constant speed. Thereby, according to the intraocular lens insertion instrument 1 of this embodiment, the intraocular lens 2 can be moved and inserted into the eye at a stable moving speed in the nozzle body 10. Therefore, the intraocular lens can be more stably ejected into the eye than a conventional intraocular lens insertion device. In addition, since the movement of the intraocular lens is stabilized, the burden on the incision provided in the eyeball is reduced.
 次に、本実施形態に係る眼内レンズ挿入器具1の製造方法について図7を参照しながら説明する。眼内レンズ挿入器具1を製造する場合は、まず、図7(a)に示すように、図3に示すノズル本体10に図5に示すプランジャー30をノズル本体10の後端部10b側から挿入する。ノズル本体10に挿入されたプランジャー30の爪部32aが係止孔10eと係合し、ノズル本体10とプランジャー30とが相対的に位置決めされる。 Next, a method for manufacturing the intraocular lens insertion device 1 according to this embodiment will be described with reference to FIG. When manufacturing the intraocular lens insertion device 1, first, as shown in FIG. 7A, the plunger 30 shown in FIG. 5 is attached to the nozzle body 10 shown in FIG. 3 from the rear end portion 10b side of the nozzle body 10. insert. The claw portion 32a of the plunger 30 inserted into the nozzle body 10 engages with the locking hole 10e, and the nozzle body 10 and the plunger 30 are relatively positioned.
 次に、眼内レンズ押出補助具20を、ノズル本体10の後端部10bとプランジャー30の挿通部32および押圧板部33とが筒状部材20a内に収まるように案内する。そして、眼内レンズ押出補助具20の各貫通孔20iにノズル本体10のホールド部11の両端が挿し通され、係合部20hとホールド部11とが係合する。これによって、本実施形態に係る眼内レンズ挿入器具1の組み立てが完了する。 Next, the intraocular lens push-out assisting tool 20 is guided so that the rear end portion 10b of the nozzle body 10, the insertion portion 32 of the plunger 30 and the pressing plate portion 33 are accommodated in the cylindrical member 20a. Then, both ends of the holding portion 11 of the nozzle body 10 are inserted into the respective through holes 20i of the intraocular lens push-out assisting tool 20, and the engaging portion 20h and the holding portion 11 are engaged. Thereby, the assembly of the intraocular lens insertion device 1 according to the present embodiment is completed.
 以上が本実施形態に関する説明であるが、上記の挿入部などの構成は、上記の実施形態に限定されるものではなく、本発明の技術的思想と同一性を失わない範囲内において種々の変更が可能である。例えば、本実施形態に係る眼内レンズ挿入器具1においては、ノッチ11aを設けない構成としてもよい。また、本実施形態では、図6(a)に示す状態のようにパッキン20cとプランジャー30の押圧板部33とが別体として設けられているが、あらかじめ押圧板部33とパッキン20cを一体として設けてもよい。 The above is the description of the present embodiment, but the configuration of the insertion portion and the like is not limited to the above-described embodiment, and various modifications can be made within the scope that does not lose the technical idea of the present invention. Is possible. For example, in the intraocular lens insertion device 1 according to the present embodiment, the notch 11a may not be provided. In the present embodiment, the packing 20c and the pressing plate portion 33 of the plunger 30 are provided as separate bodies as in the state shown in FIG. 6A, but the pressing plate portion 33 and the packing 20c are integrated in advance. You may provide as.
 以下に上記の実施形態に係る眼内レンズ挿入器具の製造方法の変形例を示す。なお、以下の説明において各構成要素は、上記の実施形態における構成要素に対応するものについては、同一の符号を付し、特に言及しない限りその説明を省略する。 Hereinafter, a modified example of the manufacturing method of the intraocular lens insertion device according to the above embodiment will be described. In the following description, components corresponding to the components in the above-described embodiment are denoted by the same reference numerals, and the description thereof is omitted unless otherwise specified.
 〔変形例1〕
 変形例1における眼内レンズ挿入器具100の製造方法を図8を参照しながら説明する。本変形例においては、まず図8(a)に示すように、眼内レンズ押出補助具20の一端の開口20jが鉛直上向きになるように、眼内レンズ押出補助具20が固定される。さらに、プランジャー30が眼内レンズ押出補助具20内に配置される。このとき、プランジャー30の押圧板部33がパッキン20cに載置される。そして、ノズル本体200が眼内レンズ押出補助具20に取り付けられる。
[Modification 1]
A method for manufacturing the intraocular lens insertion device 100 in Modification 1 will be described with reference to FIG. In this modification, first, as shown in FIG. 8A, the intraocular lens extrusion assisting tool 20 is fixed so that the opening 20j at one end of the intraocular lens extrusion assisting tool 20 is vertically upward. Furthermore, the plunger 30 is disposed in the intraocular lens pushing aid 20. At this time, the pressing plate portion 33 of the plunger 30 is placed on the packing 20c. Then, the nozzle body 200 is attached to the intraocular lens pushing assisting tool 20.
 本変形例におけるノズル本体200は、上記の実施形態におけるノズル本体10のうち、ステージ部12から後端側の部分が削除され、ステージ部12の後端側にホールド部11が連結された構成となっている。したがって、ノズル本体200が眼内レンズ押出補助具20に取り付けられる場合、プランジャー30の先端がステージ部12内に差し込まれ、ホールド部11の両端が眼内レンズ押出補助具20の係合部20hの貫通孔20iに挿し通される。この結果、図8(b)に示すように、本変形例に係る眼内レンズ挿入器具100の組み立てが完了する。 The nozzle body 200 in the present modification has a configuration in which the rear end portion of the nozzle body 10 in the above embodiment is deleted from the stage portion 12 and the hold portion 11 is connected to the rear end side of the stage portion 12. It has become. Therefore, when the nozzle body 200 is attached to the intraocular lens push-out assisting tool 20, the tip of the plunger 30 is inserted into the stage part 12, and both ends of the hold part 11 are the engaging parts 20h of the intraocular lens push-out assisting tool 20. Is inserted through the through hole 20i. As a result, as shown in FIG. 8B, the assembly of the intraocular lens insertion device 100 according to this modification is completed.
 なお、本変形例では、眼内レンズ押出補助具20の一端の開口20jが鉛直上向きになるように、眼内レンズ押出補助具20が固定されるが、眼内レンズ挿入器具100の組み立てが行えれば、眼内レンズ押出補助具20の姿勢はこれに限定されない。たとえば、プランジャー30を眼内レンズ押出補助具20内に配置する際に、プランジャー30の押圧板部33をパッキン20cに接着したり、パッキン20cに凹みを形成して凹みに押圧板部33を嵌め入れる構成にしたりすれば、眼内レンズ押出補助具20を鉛直上向き以外の姿勢にして眼内レンズ挿入器具100の組み立てを行うことができる。 In this modification, the intraocular lens push-out aid 20 is fixed so that the opening 20j at one end of the intraocular lens push-out aid 20 is vertically upward, but the intraocular lens insertion device 100 can be assembled. If so, the posture of the intraocular lens extrusion assisting tool 20 is not limited to this. For example, when the plunger 30 is placed in the intraocular lens push-out assisting tool 20, the pressing plate portion 33 of the plunger 30 is bonded to the packing 20c, or a depression is formed in the packing 20c to form the pressing plate portion 33 in the depression. Or the like, the intraocular lens insertion aid 100 can be assembled with the intraocular lens push-out assisting tool 20 in a posture other than vertically upward.
 〔変形例2〕
 次に、変形例2における眼内レンズ挿入器具300の製造方法を図9を参照しながら説明する。本変形例においては、上記の実施形態におけるノズル本体10と眼内レンズ押出補助具20の筒状部材20aとがあらかじめ一体的に成形されている。なお、眼内レンズ挿入器具300の眼内レンズ押出補助具20は、上記の実施形態における眼内レンズ押出補助具20の係合部20hが削除され、筒状部材20aの一端がノズル本体10のホールド部18に接合されている。
[Modification 2]
Next, a method for manufacturing the intraocular lens insertion device 300 in Modification 2 will be described with reference to FIG. In this modification, the nozzle body 10 and the cylindrical member 20a of the intraocular lens push-out assisting tool 20 in the above embodiment are integrally formed in advance. Note that the intraocular lens push-out assisting tool 20 of the intraocular lens insertion device 300 has the engagement portion 20h of the intraocular lens push-out assisting tool 20 in the above embodiment removed, and one end of the cylindrical member 20a is the nozzle body It is joined to the hold unit 18.
 本変形例においては、まず図9(a)に示すように、プランジャー30が筒状部材20aに挿し通され、さらにプランジャー30の先端がノズル本体10の後端部10bからノズル本体10に差し込まれる。次いで、パッキン20cが筒状部材20aの後端側から筒状部材20a内に嵌め入れられる。そして、流体供給部20dが筒状部材20aの後端に接合される。この結果、図9(b)に示すように、本変形例に係る眼内レンズ挿入器具300の組み立てが完了する。 In this modification, first, as shown in FIG. 9A, the plunger 30 is inserted through the cylindrical member 20 a, and the tip of the plunger 30 is further moved from the rear end portion 10 b of the nozzle body 10 to the nozzle body 10. Plugged in. Next, the packing 20c is fitted into the cylindrical member 20a from the rear end side of the cylindrical member 20a. And the fluid supply part 20d is joined to the rear end of the cylindrical member 20a. As a result, as shown in FIG. 9B, the assembly of the intraocular lens insertion device 300 according to this modification is completed.
 〔変形例3〕
 次に、変形例3における眼内レンズ挿入器具400について図10を参照しながら説明する。本変形例においては、眼内レンズ挿入器具400の側面視(図10(a))において、ホールド部11のノズル本体10の先端部10a側に、フック400aが設けられている。図10(a)に示すように、フック400aは、ホールド部11の上端側と下端側とにそれぞれ1つずつ設けられている。図10(b)に示すように、フック400aには、ノズル本体10を保護するノズルカバー420を取り付けることができる。なお、ノズル本体10を保護するノズルカバー420の取り付け構造としては、フック400aに限定するものではなく、圧入によって嵌合するような取り付け構造であってもよい。これにより、術者が眼内レンズ挿入器具400を保持しているときに、意図せず位置決め部材50ステージ部12から取り外したりステージ蓋部13を開蓋したりすることを防止できる。さらに、ノズル本体10とプランジャー30が、眼内レンズ押出補助具20とノズルカバー420とで保護されているため、眼内レンズ挿入器具を収納するためのいわゆるブリスターケースを使用する必要がなく、眼内レンズ挿入器具400をそのまま滅菌バックに収納するだけでよい。
[Modification 3]
Next, an intraocular lens insertion device 400 in Modification 3 will be described with reference to FIG. In the present modification, a hook 400a is provided on the distal end portion 10a side of the nozzle body 10 of the hold portion 11 in a side view of the intraocular lens insertion device 400 (FIG. 10A). As illustrated in FIG. 10A, one hook 400 a is provided on each of the upper end side and the lower end side of the hold unit 11. As shown in FIG. 10B, a nozzle cover 420 that protects the nozzle body 10 can be attached to the hook 400a. The attachment structure of the nozzle cover 420 that protects the nozzle body 10 is not limited to the hook 400a, and may be an attachment structure that fits by press fitting. Thereby, when the operator is holding the intraocular lens insertion device 400, it is possible to prevent the positioning member 50 from being unintentionally detached from the stage portion 12 or opening the stage lid portion 13 unintentionally. Furthermore, since the nozzle body 10 and the plunger 30 are protected by the intraocular lens extrusion assisting tool 20 and the nozzle cover 420, it is not necessary to use a so-called blister case for housing the intraocular lens insertion instrument, It is only necessary to store the intraocular lens insertion device 400 in a sterile bag as it is.
 〔変形例4〕
 次に、変形例4における眼内レンズ挿入器具500について図11を参照しながら説明する。本変形例においては、流体供給部20dの後側の端面の開口20eに接続されているチューブ40にコック510が設けられている。コック510には注射筒520の先端が接続されている。なお、コック510が流路切替手段の一例に相当する。注射筒520のプランジャー520aが注射筒520の先端側に押し込まれると、パッキン520bと注射筒520の先端との間にある空気がコック510およびチューブ40を経由して、流体供給部20dに移動する。また、注射筒520のプランジャー520aが注射筒520の後端側に引き戻されると、コック510とパッキン20cとの間にある空気がコック510を経由して、パッキン520bと注射筒520の先端との間に移動する。
[Modification 4]
Next, an intraocular lens insertion device 500 in Modification 4 will be described with reference to FIG. In this modification, a cock 510 is provided in the tube 40 connected to the opening 20e on the rear end face of the fluid supply unit 20d. The tip of a syringe barrel 520 is connected to the cock 510. The cock 510 corresponds to an example of a flow path switching unit. When the plunger 520a of the syringe barrel 520 is pushed into the distal end side of the syringe barrel 520, the air between the packing 520b and the distal end of the syringe barrel 520 moves to the fluid supply portion 20d via the cock 510 and the tube 40. To do. Further, when the plunger 520a of the syringe barrel 520 is pulled back to the rear end side of the syringe barrel 520, the air between the cock 510 and the packing 20c passes through the cock 510 and the tip of the packing 520b and the syringe barrel 520. Move between.
 眼内レンズ挿入器具500の保管中に、パッキン20cが眼内レンズ押出補助具20の筒状部材20aの内壁に固着する可能性がある。このような場合に、筒状部材20aとパッキン20cと流体供給部20dとで囲まれる第1の領域20fに、流体供給源により空気が供給され続けると、第1の領域20f内の空気圧が上昇し、術者が意図しないタイミングで、筒状部材20aの内壁に対するパッキン20cの固着が解除されてパッキン20cの移動が開始する可能性がある。本変形例では、術者は、流体供給源による第1の領域20fへの空気の供給を開始する前に、プランジャー520aを操作して注射筒520から第1の領域20fに空気を送り込むことで、筒状部材20aの内壁に対するパッキン20cの固着を解除することができる。なお、パッキン20cの固着を解除する方法としては、空気を供給するのみならず空気を吸引することであってもよい。このようにパッキン20cの固着が解除された後に流体供給源による第1の領域20fへの空気の供給を開始することができるため、空気の供給開始と略同時にパッキン20cの移動が開始するようにすることができる。この結果、流体供給源による第1の領域20fへの空気の供給時に、上記のように術者が意図しないタイミングでパッキン20cの移動が開始することを防止することができる。 During the storage of the intraocular lens insertion device 500, the packing 20c may adhere to the inner wall of the cylindrical member 20a of the intraocular lens push-out assisting tool 20. In such a case, if air is continuously supplied from the fluid supply source to the first region 20f surrounded by the cylindrical member 20a, the packing 20c, and the fluid supply unit 20d, the air pressure in the first region 20f increases. Then, there is a possibility that the packing 20c is released from being fixed to the inner wall of the tubular member 20a and the movement of the packing 20c starts at a timing not intended by the operator. In this modification, the surgeon operates the plunger 520a to send air from the syringe barrel 520 to the first region 20f before starting the supply of air to the first region 20f by the fluid supply source. Thus, the fixing of the packing 20c to the inner wall of the cylindrical member 20a can be released. In addition, as a method for releasing the fixation of the packing 20c, not only supplying air but also sucking air may be used. Thus, since the supply of air to the first region 20f by the fluid supply source can be started after the fixation of the packing 20c is released, the movement of the packing 20c starts almost simultaneously with the start of air supply. can do. As a result, when the air is supplied to the first region 20f by the fluid supply source, the movement of the packing 20c can be prevented from starting at a timing not intended by the operator as described above.
 なお、パッキン20cとプランジャー30の押圧板部33とが一体的に固定されていれば、術者は、注射筒520のプランジャー520aを注射筒520の後端側に引き戻すことで、ノズル本体10の先端部10a側に移動したプランジャー30を、再度流体供給部20d側に引き戻すこともできる。また、上記の説明では流体供給源および注射筒520から供給される流体を空気として説明したが、使用する流体は空気に限られない。また、注射筒520の形状は、流体を供給または吸引する機能を有するものであれば、本変形例に示す形状に限定されるものではない。 If the packing 20c and the pressing plate portion 33 of the plunger 30 are integrally fixed, the surgeon pulls back the plunger 520a of the syringe barrel 520 to the rear end side of the syringe barrel 520, so that the nozzle body The plunger 30 that has moved to the tip portion 10a side of 10 can be pulled back to the fluid supply portion 20d side again. In the above description, the fluid supplied from the fluid supply source and the syringe barrel 520 has been described as air. However, the fluid to be used is not limited to air. Further, the shape of the syringe barrel 520 is not limited to the shape shown in the present modified example as long as it has a function of supplying or sucking fluid.
 〔変形例5〕
 次に、変形例5における眼内レンズ挿入器具600について図12を参照しながら説明する。本変形例においては、流体供給部20dの後側の端面の開口20eに接続されているチューブ40にコック610が設けられている。チューブ40における流体供給源から供給される流体の流路は、コック610によってあらかじめ遮断されている。そして、術者は、流体供給源による第1の領域20fへの流体の供給を開始する際に、コック610を操作して流体の流路を開放する。このようにコック610によって流体供給源による第1の領域20fへの流体の供給を制御することができるため、例えば術者が眼内レンズ挿入器具600を使用するための準備中に、意図せず流体供給源によって第1の領域20fに流体が供給されてパッキン20cの移動が開始することを防止することができる。なお、コック610が、チューブ40の流路開閉手段の一例に相当する。
[Modification 5]
Next, an intraocular lens insertion device 600 in Modification 5 will be described with reference to FIG. In this modification, a cock 610 is provided in the tube 40 connected to the opening 20e on the rear end face of the fluid supply unit 20d. The flow path of the fluid supplied from the fluid supply source in the tube 40 is blocked in advance by the cock 610. Then, when starting the supply of fluid to the first region 20f by the fluid supply source, the operator operates the cock 610 to open the fluid flow path. Since the supply of fluid to the first region 20f by the fluid supply source can be controlled by the cock 610 in this manner, for example, during preparation for the operator to use the intraocular lens insertion device 600, it is not intended. It can be prevented that the fluid is supplied to the first region 20f by the fluid supply source and the packing 20c starts to move. The cock 610 corresponds to an example of the channel opening / closing means of the tube 40.
1、100、300  眼内レンズ挿入器具
2  眼内レンズ
2a  レンズ本体
2b  支持部
10、200  ノズル本体
20  眼内レンズ押出補助具
20a  筒状部材
20b  孔
20c  パッキン
20d  流体供給部
20e  開口
20f  第1の領域
20g  第2の領域
20h  係合部
20i  貫通孔
30  プランジャー
33  押圧板部
510、610  コック
520  注射筒
1, 100, 300 Intraocular lens insertion device 2 Intraocular lens 2a Lens body 2b Support unit 10, 200 Nozzle body 20 Intraocular lens extrusion assisting tool 20a Tubular member 20b Hole 20c Packing 20d Fluid supply unit 20e Opening 20f First Region 20g Second region 20h Engagement portion 20i Through hole 30 Plunger 33 Pressing plate portion 510, 610 Cock 520 Syringe

Claims (14)

  1.  眼内レンズを眼内に挿入する挿入筒部を先端に有する略筒状の器具本体と、
     前記器具本体内を摺動可能に設けられ、前記眼内レンズを押圧して前記挿入筒部に移動させて眼内に押し出す眼内レンズ押出部材と、
     前記器具本体に固定される筒状部材と、
     前記筒状部材内に流体を供給する流体供給手段と、
     前記筒状部材内に設けられ、前記供給される流体の圧力で移動する移動部材と、
    を備え、
     前記眼内レンズ押出部材は、前記移動部材によって押されることにより前記器具本体内を摺動する
    ことを特徴とする眼内レンズ挿入器具。
    A substantially cylindrical instrument body having an insertion tube portion for inserting an intraocular lens into the eye at the tip;
    An intraocular lens pushing member that is slidably provided in the instrument body, pushes the intraocular lens, moves it to the insertion tube, and pushes it into the eye;
    A cylindrical member fixed to the instrument body;
    Fluid supply means for supplying fluid into the tubular member;
    A moving member provided in the cylindrical member and moved by the pressure of the supplied fluid;
    With
    The intraocular lens pushing member is slid in the device body by being pushed by the moving member.
  2.  前記筒状部材は、前記眼内レンズ押出部材の摺動方向に延在し、
     前記移動部材は、前記筒状部材内を第1の領域と第2の領域とに仕切る板壁体であり、
     前記眼内レンズ押出部材は、前記第2の領域内に配置されており、
     前記流体供給手段によって前記流体が前記第1の領域に供給され、
     前記移動部材は、前記第1の領域に供給される前記流体の圧力で前記筒状部材の内壁に当接しながら移動する
    ことを特徴とする請求項1に記載の眼内レンズ挿入器具。
    The cylindrical member extends in the sliding direction of the intraocular lens pushing member,
    The moving member is a plate wall that partitions the inside of the cylindrical member into a first region and a second region,
    The intraocular lens pushing member is disposed in the second region;
    The fluid is supplied to the first region by the fluid supply means;
    2. The intraocular lens insertion device according to claim 1, wherein the moving member moves while abutting against an inner wall of the cylindrical member by pressure of the fluid supplied to the first region.
  3.  前記板壁体は前記筒状部材の内壁と当接する弾性部材を有する、ことを特徴とする請求項2に記載の眼内レンズ挿入器具。 The intraocular lens insertion device according to claim 2, wherein the plate wall body includes an elastic member that comes into contact with an inner wall of the cylindrical member.
  4.  前記眼内レンズ押出部材の前記摺動方向に垂直な面における前記板壁体の断面の断面積が、前記摺動方向に垂直な面における前記器具本体の断面の断面積よりも大きい、
    ことを特徴とする請求項2または3に記載の眼内レンズ挿入器具。
    The cross-sectional area of the cross-section of the plate wall body in the plane perpendicular to the sliding direction of the intraocular lens pushing member is larger than the cross-sectional area of the cross-section of the instrument body in the plane perpendicular to the sliding direction;
    The intraocular lens insertion device according to claim 2 or 3.
  5.  前記筒状部材内にある前記第1の領域が、閉空間でない、ことを特徴とする請求項2から4のいずれか1項に記載の眼内レンズ挿入器具。 The intraocular lens insertion device according to any one of claims 2 to 4, wherein the first region in the cylindrical member is not a closed space.
  6.  前記流体供給手段は、前記筒状部材内に前記流体を供給する供給口を有し、
     前記供給口の内径は、前記筒状部材の内径よりも小さい
    ことを特徴とする請求項1から5のいずれか1項に記載の眼内レンズ挿入器具。
    The fluid supply means has a supply port for supplying the fluid into the cylindrical member,
    The intraocular lens insertion device according to any one of claims 1 to 5, wherein an inner diameter of the supply port is smaller than an inner diameter of the cylindrical member.
  7.  前記流体供給手段の前記供給口には、軟性部材により形成されるチューブが接続可能である、ことを特徴とする請求項6に記載の眼内レンズ挿入器具。 The intraocular lens insertion device according to claim 6, wherein a tube formed of a soft member is connectable to the supply port of the fluid supply means.
  8.  前記流体供給手段は、前記筒状部材内に前記流体を供給する供給口を有し、
     前記眼内レンズ挿入器具がさらに、
      前記供給口に接続された、軟性部材により形成されるチューブと、
      前記チューブに設けられた、前記流体の流路と前記流体の流路とは別の流路とを切り替える流路切替手段と、
      前記別の流路に接続される注射筒と
    を備えることを特徴とする請求項1から5のいずれか1項に記載の眼内レンズ挿入器具。
    The fluid supply means has a supply port for supplying the fluid into the cylindrical member,
    The intraocular lens insertion device further comprises:
    A tube formed of a flexible member connected to the supply port;
    A flow path switching means provided in the tube, for switching between the flow path of the fluid and a flow path different from the flow path of the fluid;
    The intraocular lens insertion device according to any one of claims 1 to 5, further comprising an injection cylinder connected to the another flow path.
  9.  前記流体供給手段は、前記筒状部材内に前記流体を供給する供給口を有し、
     前記眼内レンズ挿入器具がさらに、
      前記供給口に接続された、軟性部材により形成されるチューブと、
      前記チューブに設けられた、前記流体の流路の遮断および開放を制御する流路開閉手段と
    を備えることを特徴とする請求項1から5のいずれか1項に記載の眼内レンズ挿入器具。
    The fluid supply means has a supply port for supplying the fluid into the cylindrical member,
    The intraocular lens insertion device further comprises:
    A tube formed of a flexible member connected to the supply port;
    The intraocular lens insertion device according to any one of claims 1 to 5, further comprising: a channel opening / closing unit that is provided in the tube and that controls blocking and opening of the fluid channel.
  10.  前記眼内レンズ挿入器具の前記挿入筒部には、あらかじめ眼内レンズが眼内レンズ挿入器具に収納されていることを特徴とする請求項1から9のいずれか1項に記載の眼内レンズ挿入器具。 The intraocular lens according to any one of claims 1 to 9, wherein an intraocular lens is accommodated in the intraocular lens insertion device in advance in the insertion tube portion of the intraocular lens insertion device. Insertion instrument.
  11.  眼内レンズを眼内に挿入する挿入筒部を先端に有する略筒状の器具本体に固定される筒状部材と、
     前記筒状部材内に流体を供給する流体供給手段と、
     前記筒状部材内に設けられ、前記供給される流体の圧力で移動する移動部材と、
    を備え、
     前記器具本体内を摺動可能に設けられ、前記眼内レンズを押圧して前記挿入筒部に移動させて眼内に押し出す眼内レンズ押出部材が、前記移動部材によって押されることにより前記器具本体内を摺動する
    ことを特徴とする眼内レンズ押出補助具。
    A cylindrical member fixed to a substantially cylindrical instrument body having an insertion cylindrical portion for inserting an intraocular lens into the eye;
    Fluid supply means for supplying fluid into the tubular member;
    A moving member provided in the cylindrical member and moved by the pressure of the supplied fluid;
    With
    An intraocular lens push-out member that is slidably provided in the instrument body, presses the intraocular lens, moves it to the insertion tube portion, and pushes it into the eye is pushed by the moving member, thereby the instrument body An intraocular lens extruding aid characterized by sliding inside.
  12.  請求項1から10のいずれか1項に係る眼内レンズ挿入器具の製造方法であって、
     前記器具本体に、前記眼内レンズ押出部材を挿入する工程と、
     前記眼内レンズ押出部材を挿入する工程の後に、前記器具本体に、前記流体供給手段および前記移動部材が設けられている前記筒状部材を固定する工程と
    を有することを特徴とする眼内レンズ挿入器具の製造方法。
    A method for manufacturing an intraocular lens insertion device according to any one of claims 1 to 10,
    Inserting the intraocular lens pushing member into the instrument body;
    After the step of inserting the intraocular lens pushing member, the step of fixing the cylindrical member provided with the fluid supply means and the moving member to the instrument body is provided. A method for manufacturing an insertion device.
  13.  請求項1から10のいずれか1項に係る眼内レンズ挿入器具の製造方法であって、
     前記流体供給手段および前記移動部材が設けられている前記筒状部材に、前記眼内レンズ押出部材を挿入する工程と、
     前記眼内レンズ押出部材を挿入する工程の後に、前記筒状部材に、前記器具本体を固定する工程と
    を有することを特徴とする眼内レンズ挿入器具の製造方法。
    A method for manufacturing an intraocular lens insertion device according to any one of claims 1 to 10,
    Inserting the intraocular lens pushing member into the cylindrical member provided with the fluid supply means and the moving member;
    A method of manufacturing an intraocular lens insertion device, comprising: a step of fixing the device body to the cylindrical member after the step of inserting the intraocular lens pushing member.
  14.  請求項1から10のいずれか1項に係る眼内レンズ挿入器具の製造方法であって、
     前記器具本体とあらかじめ一体的に成形された前記筒状部材に、前記眼内レンズ押出部材を挿入する工程と、
     前記筒状部材に、前記移動部材を挿入する工程と、
     前記筒状部材に、前記流体供給手段を設ける工程と
    を有することを特徴とする眼内レンズ挿入器具の製造方法。
    A method for manufacturing an intraocular lens insertion device according to any one of claims 1 to 10,
    Inserting the intraocular lens extruding member into the tubular member formed integrally with the instrument body in advance;
    Inserting the moving member into the tubular member;
    And a step of providing the fluid supply means on the tubular member. A method for manufacturing an intraocular lens insertion device.
PCT/JP2016/068852 2015-06-25 2016-06-24 Intraocular lens insertion instrument, intraocular lens extraction assistance tool, and method for manufacturing intraocular lens insertion instrument WO2016208725A1 (en)

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US10172706B2 (en) 2015-10-31 2019-01-08 Novartis Ag Intraocular lens inserter
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