WO2022149249A1 - Implant and implant system - Google Patents

Implant and implant system Download PDF

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Publication number
WO2022149249A1
WO2022149249A1 PCT/JP2021/000404 JP2021000404W WO2022149249A1 WO 2022149249 A1 WO2022149249 A1 WO 2022149249A1 JP 2021000404 W JP2021000404 W JP 2021000404W WO 2022149249 A1 WO2022149249 A1 WO 2022149249A1
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WO
WIPO (PCT)
Prior art keywords
implant
removal
eye
intraocular pressure
pipe
Prior art date
Application number
PCT/JP2021/000404
Other languages
French (fr)
Japanese (ja)
Inventor
功 大高
Original Assignee
株式会社ドックスネット
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 株式会社ドックスネット filed Critical 株式会社ドックスネット
Priority to PCT/JP2021/000404 priority Critical patent/WO2022149249A1/en
Publication of WO2022149249A1 publication Critical patent/WO2022149249A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods 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
    • A61F9/007—Methods or devices for eye surgery

Definitions

  • the present invention relates to an implant and an implant system.
  • the implant described in Patent Document 1 can be attached to the eye.
  • the implant comprises a tube portion and a throttle portion.
  • Aqueous humor flow path is formed inside the pipe portion.
  • the throttle portion is arranged in the flow path.
  • the throttle portion includes a wall portion arranged in the flow path and a hole portion penetrating the wall portion.
  • the laser beam passes through the tube portion and irradiates the wall portion arranged inside the tube portion.
  • the wall portion is removed from the flow path by being irradiated with laser light. By removing the wall, the intraocular pressure is adjusted.
  • the structure of the implant may be complicated.
  • the present invention has been made in view of the above problems, and an object of the present invention is to provide an implant capable of adjusting intraocular pressure with a simple structure and an implant system.
  • the first aspect of the present disclosure is intended for implants.
  • the implant can be attached to the eye.
  • the implant includes a tube portion in which a flow path of aqueous humor is formed inside, and the outer surface portion of the tube portion is irradiated with laser light to provide an outside of the tube portion and a flow path of the tube portion.
  • a removing portion is provided to be removed so as to communicate.
  • a second aspect of the present disclosure is, in the first aspect, the pipe portion further includes a hole portion communicating the outside of the pipe portion and the flow path of the pipe portion, and the removal portion is the hole portion. Placed around.
  • a third aspect of the present disclosure is, in the first or second aspect, the tubular portion having an distal end portion placed in the anterior chamber of the eye with the implant attached to the eye. Including, the removing portion is arranged on the tip side portion.
  • a fourth aspect of the present disclosure is, in any one of the first to third aspects, the implant is attached to the eye and the removal portion is placed in the anterior chamber of the eye. Will be done.
  • a fifth aspect of the present disclosure is, in any one of the first to fourth aspects, in a state where the implant is attached to the eye, the removal portion is the back side of the cornea of the eye. Is placed in.
  • a sixth aspect of the present disclosure is, in any one of the first to fifth aspects, the removing portion being removed by irradiating the laser beam passing through the cornea of the eye.
  • a plurality of the removing portions are arranged in the pipe portion.
  • the plurality of removing portions have different dimensions from each other.
  • the ninth aspect of the present disclosure is intended for implant systems.
  • the implant system includes the implant, an irradiation unit that irradiates the laser beam, and a measurement unit that measures intraocular pressure.
  • the implant of the present invention can adjust intraocular pressure with a simple structure.
  • FIG. 2 is a sectional view taken along line II-II of FIG. It is a schematic cross-sectional view which shows the implant in the state of being attached to an eye. It is a partially enlarged view of FIG.
  • A) is a plan view of the first example of the tip end side portion of the pipe portion.
  • B) is a side sectional view of the first example of the tip side portion shown in (a).
  • A) is a plan view of the tip end side portion of the pipe portion after the removal portion is removed.
  • (B) is a side sectional view of FIG. 6 (a).
  • A) is a plan view of the second example of the tip side portion.
  • FIG. 7 is a side sectional view of the second example of the tip side portion shown in FIG. 7 (a).
  • A) is a plan view which shows the tip side part after removal of the removal part.
  • B) is a cross-sectional view showing a tip side portion after removal of the removed portion.
  • A) is a plan view of the third example of the tip side portion.
  • B) is a side sectional view of a third example of the tip end side portion 15 shown in FIG. 9 (a).
  • It is a flowchart which shows the procedure which adjusts the intraocular pressure of the eye which attached the implant.
  • It is a schematic cross-sectional view which shows the implant which does not have a plate part.
  • (A) is a plan view of the fourth example of the structure of the tip end side portion of the pipe portion.
  • (B) is a side sectional view of the fourth example of the tip side portion shown in FIG. 12 (a).
  • (C) is a plan view of the tip end side portion of the pipe portion after removal of the plurality of removed portions. It is a figure which shows the change information.
  • (A) is a plan view of the fifth example of the structure of the tip end side portion of the pipe portion.
  • (B) is a side sectional view of the fifth example of the tip side portion shown in FIG. 14 (a).
  • (A) is a side sectional view of a modified example of a pipe portion.
  • (B) is a side sectional view of a modified example of the pipe portion.
  • FIG. 1 is a perspective view of the implant 10.
  • FIG. 2 is a sectional view taken along line II-II of FIG.
  • the implant 10 is used for the treatment of glaucoma.
  • the implant 10 can be attached to the eye.
  • the implant 10 promotes the outflow of aqueous humor from the eye. As a result, it becomes possible to suppress an abnormal increase in intraocular pressure.
  • the implant 10 includes a tube portion 1 and a plate portion 3.
  • the tube portion 1 has a tubular shape. That is, the pipe portion 1 has a hollow shape.
  • the tube portion 1 has flexibility, flexibility, and / or elasticity.
  • the tube portion 1 is formed of, for example, silicone, an elastomer resin, or an elastic resin material.
  • the tube portion 1 of the present embodiment is a silicone tube.
  • the pipe portion 1 has a first end portion 1a and a second end portion 1b.
  • the pipe portion 1 has a long shape extending from the first end portion 1a toward the second end portion 1b.
  • Aqueous humor flow path 11 is formed inside the pipe portion 1.
  • the flow path 11 indicates a space surrounded by the inner surface of the pipe portion 1.
  • the flow path 11 has, for example, an inner diameter of about 0.5 mm.
  • the tube portion 1 guides the aqueous humor generated by the eye to the outside of the eye through the flow path 11.
  • the pipe portion 1 includes a first opening portion 12 and a second opening portion 13. Both ends of the pipe portion 1 are opened by the first opening portion 12 and the second opening portion 13.
  • the first opening 12 is formed at the first end 1a.
  • the first opening 12 communicates the flow path 11 with the outside of the pipe portion 1.
  • the second opening 13 is formed at the second end 1b.
  • the second opening 13 communicates the flow path 11 with the outside of the pipe portion 1.
  • the pipe portion 1 discharges the aqueous humor that has flowed into the flow path 11 through the first opening 12 from the flow path 11 through the second opening 13.
  • the pipe portion 1 further includes a lid portion 14, a tip side portion 15, and a removal portion 16.
  • the lid portion 14 is a member separate from the pipe portion 1, is fixed to the first end portion 1a, and closes the first opening portion 12 (see FIG. 5B).
  • the lid portion 14 is a member integrated with the pipe portion 1, the tip end side portion 15 of the pipe portion 1 does not have the first opening portion 12, and the tip end side portion 15 is originally closed by the lid portion 14. It may have been done.
  • the pipe portion 1 has a first structure and a second structure.
  • the first structure shows either a structure in which the lid portion 14 is integrally formed with the pipe portion 1 or a structure in which the lid portion 14 is formed separately.
  • the second structure shows either a structure in which the distal end side portion 15 of the pipe portion 1 has the first opening portion 12 or a structure in which the tip end side portion 15 does not have the first opening portion 12.
  • the tip end side portion 15 indicates a portion of the pipe portion 1 located on the first opening 12 side.
  • the removing portion 16 is provided on the outer surface portion 1c of the pipe portion 1.
  • the removing portion 16 is arranged on the tip end side portion 15 of the pipe portion 1.
  • the removing portion 16 communicates with the outside of the pipe portion 1 and the flow path 11 of the pipe portion 1 by being removed from the pipe portion 1.
  • the plate portion 3 has a plate-like shape.
  • the plan view shape of the plate portion 3 is, for example, a circular shape, an elliptical shape, or a square shape having curved corners.
  • the plate portion 3 has a main surface 31 and a main body portion 32.
  • the main surface 31 of the plate portion 3 is formed on the main body portion 32.
  • the area of the main surface 31 of the plate portion 3 is, for example, 100 square millimeters or more and 600 square millimeters or less.
  • the main surface 31 of the plate portion 3 has a curved surface shape along the surface of the eyeball.
  • the radius of curvature of the main surface 31 of the plate portion 3 is, for example, 12 mm or more and 14 mm or less.
  • the thickness of the plate portion 3 is, for example, 0.5 mm or more and 2 mm or less.
  • the plate portion 3 is formed of, for example, a material having flexibility, flexibility, or elasticity. Specifically, the plate portion 3 is formed of, for example, a material containing a silicon elastomer. As a result, it becomes possible to deform the plate portion 3 into a curved surface shape along the surface of the eyeball while the implant 10 is attached to the eye.
  • the pipe portion 1 is fixed to the plate portion 3. Specifically, the second end portion 1b of the pipe portion 1 is fixed to the plate portion 3. The second end portion 1b of the pipe portion 1 is arranged on the upper portion of the plate portion 3 (main body portion 32). On the other hand, the first end portion 1a of the pipe portion 1 is located on the outer side of the plate portion 3.
  • the plate portion 3 further has a bulging portion 33, a suture hole 34, a convex portion 35, a plurality of through holes 36, and an insertion hole 37.
  • the bulging portion 33 bulges from the main body portion 32.
  • the suture hole 34 is formed in the bulge 33.
  • the suture hole 34 penetrates the bulge 33.
  • the convex portion 35 has a shape protruding upward from the main body portion 32.
  • An insertion hole 37 is formed between the convex portion 35 and the main body portion 32.
  • the pipe portion 1 is inserted into the insertion hole 37.
  • the pipe portion 1 is fixed to the main body portion 32 in a state of being inserted into the insertion hole 37.
  • the second end portion 1b of the pipe portion 1 is fixed to the main body portion 32 in a state of being inserted into the insertion hole 37.
  • Each of the plurality of through holes 36 penetrates the plate portion 3. Specifically, each of the plurality of through holes 36 penetrates the main body portion 32 of the plate portion 3.
  • FIG. 3 is a schematic cross-sectional view showing the implant 10 in a state of being attached to the eye 200.
  • FIG. 4 is a partially enlarged view of FIG.
  • the plate portion 3 is inserted between the sclera 201 and the tenon sac 203.
  • a suture thread is inserted into the suture hole 34 (see FIG. 1) of the plate portion 3.
  • the suture is inserted through the suture hole 34 and sutures the plate portion 3 and the sclera 201.
  • the plate portion 3 is fixed to the sclera 201.
  • the biological tissue in the eye grows. Then, the biological tissue in the eye connects between the tenon sac 203 and the sclera 201 through each of the plurality of through holes 36 (see FIG. 1). As a result, the position of the plate portion 3 in the eye is suppressed from being displaced, and the position of the plate portion 3 in the eye is stabilized.
  • a bleb 204 is formed around the plate portion 3 as a reaction of the human body. As the plate portion 3 continues to exist, the bleb 204 also continues to be formed. As a result, the plate portion 3 floats in the bleb 204. Bleb 204 indicates vesicles, vesicles, and / or vesicles.
  • the tube portion 1 extends from the plate portion 3 along the sclera 201 toward the anterior chamber 202 side.
  • the first end 1a of the duct 1 penetrates the sclera 201, trabecular meshwork 209 and Schlemm's canal 210 and is inserted into the anterior chamber 202.
  • the target through which the first end portion 1a penetrates is not particularly limited.
  • the tube portion 1 may penetrate the region 205 adjacent to the cornea 211 when inserted into the anterior chamber 202.
  • the first end portion 1a of the tube portion 1 is inserted into the anterior chamber 202, but the present invention is not limited thereto.
  • the first end portion 1a of the tube portion 1 may be inserted into, for example, the pars plana portion of the ciliary body.
  • the second opening 13 of the tube portion 1 is placed between the sclera 201 and the tenon sac 203.
  • a tenon sac 203 is placed between the sclera 201 and the conjunctiva 206. With the implant 10 attached to the eye 200, the tube 1 is placed so as to pass below the tenon sac 203. In addition, the tube portion 1 may be arranged so as to pass above the tenon sac 203 with the implant 10 attached to the eye 200.
  • the distal end side portion 15 and the removal portion 16 (see FIGS. 1 and 2) of the tube portion 1 are arranged in the anterior chamber 202 (inside the anterior chamber 202). Further, with the implant 10 attached to the eye 200, the distal end side portion 15 and the removal portion 16 of the tube portion 1 are arranged on the inner side of the cornea 211. The back side shows the inner side of the eye 200.
  • the removing portion 16 (see FIGS. 1 and 2) of the tube portion 1 is removed by irradiating the irradiation unit 40 with the laser beam L.
  • the laser beam L passes through the cornea 211 and irradiates the removing portion 16.
  • the operator operates the irradiation unit 40 while confirming the position of the removal unit 16 using a microscope, for example, to irradiate the removal unit 16 with the laser beam L.
  • the laser light L is, for example, a green laser, a yellow laser, a red laser, a YAG laser, or a semiconductor laser.
  • the laser beam L has a relatively long wavelength and a high depth of penetration, for example.
  • the irradiation unit 40 includes, for example, a multi-color laser photocoagulation device, a green laser photocoagulation device, a YAG laser surgery device, or a semiconductor laser device.
  • the removing portion 16 has a predetermined color.
  • the predetermined color is a color that can absorb the laser beam L, and is, for example, a dark color such as black or brown.
  • the removing portion 16 may be black or entirely on the distal end side portion 15. It is formed by coloring a dark color such as brown.
  • the operator operates the irradiation unit 40 to irradiate the removing portion 16 with the laser beam L.
  • the removed portion 16 can be easily confirmed.
  • the removing unit 16 When the removing unit 16 is irradiated with the laser light L, the removing unit 16 absorbs the laser light L. As a result, the removing portion 16 is burnt down by the energy of the laser beam L and removed from the tube portion 1.
  • the color and material of the removal unit 16 are not particularly limited.
  • the removing unit 16 may have a configuration in which it is removed by the laser beam L.
  • the removing portion 16 and the portion of the tip side portion 15 other than the removing portion 16 may be formed in the same color or may be formed in different colors. Further, the removing portion 16 and the portion of the tip side portion 15 other than the removing portion 16 may be formed of the same material or may be formed of different materials.
  • the removing portion 16 may be made of a material that is destroyed by being irradiated with the laser beam L (for example, a YAG laser) and is removed from the tube portion 1.
  • the laser beam L for example, a YAG laser
  • the alternate long and short dash arrow indicates the flow of aqueous humor.
  • the aqueous humor is produced by the ciliary body 207.
  • Aqueous humor circulates in front of the crystalline lens 208 through the pupil to the anterior chamber 202 of the eye 200 to nourish.
  • the aqueous humor is drained out of the eye through the trabecular meshwork 209 and Schlemm's canal 210.
  • clogging of the trabecular meshwork 209 prevents proper drainage of aqueous humor.
  • intraocular pressure rises beyond the normal range. When the intraocular pressure rises abnormally, for example, the pressure damages the optic nerve and impairs the visual field and visual acuity.
  • a bleb 204 is formed. Further, the aqueous humor in the anterior chamber 202 flows into the flow path 11 of the pipe portion 1, flows through the flow path 11, and then is supplied into the bleb 204. , The aqueous humor supplied into the bleb 204 permeates into the living tissue from the periphery of the bleb 204. Therefore, the aqueous humor in the anterior chamber 202 is discharged to the outside of the eye through the flow path 11. As a result, it becomes possible to suppress an abnormal increase in intraocular pressure.
  • the bleb 204 is not always formed. For example, by arranging the second opening 13 of the tube 1 behind the eye 200, the aqueous humor discharged from the second opening 13 of the tube 1 is a biological tissue without forming the bleb 204. It penetrates inside.
  • FIG. 5A is a plan view of the first example of the tip end side portion 15 of the pipe portion 1.
  • 5 (b) is a side sectional view of the first example of the tip side portion 15 shown in FIG. 5 (a).
  • the pipe portion 1 includes a hole portion 17.
  • the hole portion 17 communicates the outside of the pipe portion 1 with the flow path 11 of the pipe portion 1.
  • the removal unit P is the first example of the removal unit 16.
  • the removing portion P is arranged around the hole portion 17.
  • the fact that the removing portion P is arranged around the hole portion 17 indicates that the removing portion P is arranged so as to be in contact with all or a part of the edge portion 17a of the hole portion 17.
  • the removing portion P is in contact with the entire edge portion 17a of the hole portion 17, and is formed in an annular shape along the edge portion 17a of the hole portion 17.
  • the shapes of the hole 17 and the removal P are not particularly limited.
  • FIG. 6A is a plan view of the tip end side portion 15 of the pipe portion 1 after the removal portion P is removed.
  • 6 (b) is a side sectional view of FIG. 6 (a).
  • the aqueous humor in the anterior chamber 202 flows into the flow path 11 through the hole portion 17.
  • the aqueous humor that has flowed into the flow path 11 flows toward the second opening 13 and is discharged from the second opening 13 (see FIG. 3).
  • the laser beam L is irradiated from the irradiation unit 40 toward the removal unit P.
  • the removing portion P is removed.
  • the removing portion P is removed so as to communicate the outside of the pipe portion 1 with the flow path 11 of the pipe portion 1.
  • FIGS. 6 (a) and 6 (b) when the removed portion P is removed, a vacant space Pa is formed in the place where the removed portion P was present.
  • the vacant space Pa is formed so as to be continuous with the hole 17.
  • an enlarged hole portion PA in which the hole portion 17 and the vacant space Pa are combined is formed in the tip end side portion 15 of the pipe portion 1.
  • the cross-sectional area of the enlarged hole PA is larger than the cross-sectional area of the hole 17.
  • the cross-sectional area of the enlarged hole PA and the cross-sectional area of the hole 17 indicate the area of the cross section perpendicular to the axis of the hole 17.
  • the enlarged hole PA has a shape in which the hole 17 shown in FIGS. 6 (a) and 6 (b) is enlarged by the amount of the empty space Pa. Since the enlarged hole PA has an enlarged shape of the hole 17, a larger amount of aqueous humor than the hole 17 can flow from the anterior chamber 202 into the flow path 11. As the amount of aqueous humor flowing into the flow path 11 increases, the degree of decrease in intraocular pressure increases. The amount of aqueous humor flowing into the flow path 11 indicates, in detail, the amount of aqueous humor flowing into the flow path 11 per unit time.
  • the surgeon can adjust the intraocular pressure by removing the removal portion P.
  • the removal portion P is provided on the outer surface portion 1c of the pipe portion 1.
  • the removing portion P is removed so as to communicate the outside of the tube portion 1 with the flow path 11 of the tube portion 1 by being irradiated with the laser beam L.
  • the enlarged hole portion PA is formed.
  • the implant 10 can adjust the intraocular pressure with a simple structure in which the removal portion P is provided on the outer surface portion 1c of the tube portion 1.
  • FIG. 7A is a plan view of the second example of the tip end side portion 15.
  • FIG. 7B is a side sectional view of a second example of the tip end side portion 15 shown in FIG. 7A.
  • the removal unit Q is a second example of the removal unit 16.
  • the removing portion Q is provided on the outer surface portion 1c of the tip end side portion 15 of the pipe portion 1.
  • the shape of the removing portion Q is not particularly limited.
  • the removing portion Q is not provided with the hole portion 17 inside.
  • the removing portion Q does not enlarge the existing hole portion 17 unlike the removing portion P, but newly forms a communication hole portion QA (see FIGS. 8A and 8B) in the tip side portion 15. do.
  • the tip end side portion 15 of the pipe portion 1 is closed by the removal portion Q and the lid portion 14.
  • the aqueous humor in the anterior chamber 202 does not flow into the flow path 11 in the tube portion 1 until the removal portion Q is removed. ..
  • FIG. 8A is a plan view showing the tip end side portion 15 after the removal portion Q is removed.
  • FIG. 8B is a cross-sectional view showing the tip end side portion 15 after the removal portion Q is removed.
  • the removal portion Q is irradiated with the laser beam L in the state where the implant 10 is attached to the eye, so that the tube portion 1 is exposed to the laser beam L. It is removed so as to communicate the outside with the flow path 11 of the pipe portion 1.
  • a communication hole portion QA that communicates the outside of the pipe portion 1 with the flow path 11 of the pipe portion 1 is formed in the place where the removal portion Q is present in the pipe portion 1.
  • the surgeon can adjust the intraocular pressure by removing the removal portion Q.
  • the aqueous humor does not flow into the flow path 11 when the removal portion Q is not removed (see FIG. 7A).
  • the present invention is not limited to this.
  • the aqueous humor may be configured to flow into the flow path 11 even when the removal portion Q is not removed.
  • a hole for communicating the outside of the pipe portion 1 and the flow path 11 of the pipe portion 1 is provided, and the removal portion Q is not removed. Even in this state, the aqueous humor in the anterior chamber 202 is configured to flow into the flow path 11 through the hole.
  • the removing portion Q is removed and the communication hole portion QA (see FIG. 8B) is formed, the flow path from the anterior chamber 202 to the pipe portion 1 is formed through the existing hole and the communication hole portion QA. Since the aqueous humor flows into 11, the flow rate of the aqueous humor in the flow path 11 increases.
  • FIG. 9A is a plan view of the third example of the tip end side portion 15.
  • 9 (b) is a side sectional view of a third example of the tip side portion 15 shown in FIG. 9 (a).
  • a plurality of holes 17 are provided in the tip end side portion 15 of the pipe portion 1.
  • a removing portion P is arranged around each of the plurality of holes 17.
  • steps S1 to S5 the process of adjusting the intraocular pressure of the eye 200 to which the implant 10 is attached (steps S1 to S5) will be described with reference to FIGS. 4 and 9 (a) to 10 (10).
  • steps S1 to S5 for example, after the glaucoma operation in which the implant 10 is attached to the eye 200 is performed, the symptom worsens and the intraocular pressure becomes higher than the predetermined upper limit value. If done.
  • the process of adjusting the intraocular pressure shown in steps S1 to S5 is performed by using the third example of the structure of the distal end side portion 15 of the tube portion 1 shown in FIGS. 9 (a) and 9 (b). Will be done.
  • FIG. 10 is a flowchart showing a procedure (step S1 to step S5) for adjusting the intraocular pressure of the eye 200 to which the implant 10 is attached.
  • the processes shown in steps S1 to S5 are performed using the implant system 100.
  • the implant system 100 includes an implant 10, an irradiation unit 40, and a measurement unit 50 (see FIG. 4) for measuring intraocular pressure.
  • step S1 the intraocular pressure of the eye 200 to which the implant 10 is attached is measured.
  • the operator uses the measuring unit 50 to measure the intraocular pressure of the eye 200 to which the implant 10 is attached.
  • the measuring unit 50 for example, a tonometer.
  • the tonometer is, for example, a Goldman tonometer.
  • step S2 it is determined whether or not the measured intraocular pressure is higher than the predetermined upper limit value.
  • the predetermined upper limit indicates the upper limit of the range in which the intraocular pressure is normal.
  • the predetermined upper limit is, for example, 21 mmHg, which is generally the upper limit of normal intraocular pressure.
  • the predetermined upper limit value may be smaller than 21 mmHg.
  • a predetermined upper limit value may be set to 15 mmHg. The reason is that the intraocular pressure is adjusted before the intraocular pressure reaches 21 mmHg in consideration of the possibility that the intraocular pressure gradually increases after the measurement of the intraocular pressure, so that the normal intraocular pressure is more surely obtained. This is to secure it.
  • step S2 When the intraocular pressure is higher than the predetermined upper limit value (Yes in step S2), the process proceeds to step S3. On the other hand, when the intraocular pressure is equal to or less than a predetermined upper limit value (No in step S2), the process ends.
  • step S3 the laser beam L is irradiated from the irradiation unit 40, and one removal unit P (see FIG. 9A) is removed from the plurality of removal units P.
  • step S4 the intraocular pressure of the eye 200 to which the implant 10 is attached is measured.
  • step S5 it is determined whether or not the measured intraocular pressure is higher than the predetermined target value.
  • the process proceeds to step S3.
  • step S3 yet another removing unit P is removed.
  • the processes shown in steps S3 to S5 are repeated until the intraocular pressure is determined to be equal to or less than a predetermined target value.
  • the intraocular pressure is equal to or less than a predetermined target value (No in step S5), the process ends.
  • the predetermined target value is, for example, 10 mmHg.
  • the predetermined target value may be 21 mmHg or less.
  • steps S3 to S5 are repeated until the intraocular pressure is determined to be equal to or lower than the predetermined target value. Therefore, by removing the removal portions P one by one until the intraocular pressure becomes equal to or lower than the predetermined target value, the flow rate of the aqueous humor discharged by the tube portion 1 (second opening 13) is gradually increased. , The intraocular pressure can be gradually reduced. As a result, it is possible to suppress abrupt fluctuations in the intraocular pressure and perform the work of adjusting the intraocular pressure in a stable state.
  • a plurality of removing portions P are provided on the tip end side portion 15 of the pipe portion 1 (see FIGS. 9A and 9B), and the pipe portion 1 including the plurality of removing portions P is provided.
  • the processes shown in steps S1 to S5 are performed.
  • the present invention is not limited to this.
  • a plurality of removing portions Q are provided on the tip end side portion 15 of the pipe portion 1, and the processing shown in steps S1 to S5 is performed using the pipe portion 1 including the plurality of removing portions Q. You may be broken. In this case, each time the process shown in step S3 is performed, the plurality of removal units Q are removed one by one.
  • FIGS. 1 to 10 The embodiments of the present invention have been described above with reference to the drawings (FIGS. 1 to 10).
  • the present invention is not limited to the above embodiment, and can be implemented in various embodiments without departing from the gist of the present invention (for example, (1) to (10)).
  • various inventions can be formed by appropriately combining the plurality of components disclosed in the above embodiments. For example, some components may be removed from all the components shown in the embodiments.
  • each component is schematically shown, and the number of each component shown may differ from the actual one due to the convenience of drawing.
  • each component shown in the above embodiment is an example, and is not particularly limited, and various changes can be made without substantially deviating from the effect of the present invention.
  • the implant 10 can be attached not only to the human eye but also to the eye of a non-human animal such as a dog. Further, the method of adjusting the intraocular pressure of the eye to which the implant 10 is attached (see steps S1 to S5) can be applied not only to humans but also to animals other than humans.
  • the implant 10 to be attached to the patient's eye may be selected from the plurality of implants 10.
  • the implant 10 has a larger size of the removed portion 16 and / or a larger cross-sectional area of the flow path 11 as the patient's symptom becomes heavier.
  • the cross-sectional area of the flow path 11 indicates the area of the cross section perpendicular to the extending direction of the flow path 11.
  • the implant 10 of the present embodiment includes a tube portion 1 and a plate portion 3.
  • the present invention is not limited to this.
  • the implant 10 does not have to include the plate portion 3, and may at least include the tube portion 1 including the removal portion 16. That is, the implant 10 may have a function of forming a flow path 11 inside the tube portion 1 and guiding the aqueous humor generated by the eye 200 to the outside of the eye 200 through the flow path 11.
  • the implant 10 does not have the plate portion 3 and has the tubular portion 1 including the removal portion 16
  • the implant 10 is in the state shown in the following (i) to (iii). become.
  • the first end 1a of the tube 1 is inserted into the anterior chamber 202.
  • the middle part of the tube portion 1 is arranged between the sclera 201 and the conjunctiva 206.
  • the second end portion 1b of the tube portion 1 is directly or indirectly fixed to the rear portion of the sclera 201.
  • the posterior part of the sclera 201 indicates the portion of the sclera 201 located behind the eye 200 with respect to the conjunctiva 206.
  • the tube portion 1 of the present embodiment is arranged so as to extend from the anterior chamber 202 to the posterior side of the eye 200.
  • the place where the pipe portion 1 is arranged is not particularly limited.
  • the tube portion 1 may be arranged at a place where the aqueous humor can be guided to the outside of the eye 200 through the flow path 11.
  • one removal unit 16 is removed each time the process shown in step S3 (see FIG. 10) is performed, but the present invention is not limited to this.
  • two or more removing units 16 may be removed in step S3. That is, the number of removing portions 16 to be removed in step S3 is changed according to the height of the intraocular pressure measured in step S1.
  • the number of removing portions 16 to be removed is determined by the operator. The number of removing portions 16 to be removed in step S3 may be determined, for example, based on the operator's empirical rule.
  • step S3 the number of removal units 16 to be removed is determined from the first removal unit P1 to the Nth removal unit PN according to the magnitude of the intraocular pressure measured in step S1. As a result, it becomes possible to efficiently perform the work of lowering the intraocular pressure below a predetermined target value.
  • FIG. 12A is a plan view of a fourth example of the structure of the distal end side portion 15 of the pipe portion 1.
  • 12 (b) is a side sectional view of a fourth example of the tip end side portion 15 shown in FIG. 12 (a).
  • FIG. 12 (c) is a plan view of the tip end side portion 15 of the pipe portion 1 after the removal of the plurality of removal portions P.
  • a plurality of holes 17 and a plurality of removal portions P are provided in the tip end side portion 15 of the pipe portion 1.
  • the plurality of hole portions 17 include the first hole portion 171 to the Nth hole portion 17N.
  • N is an integer of 2 or more.
  • the plurality of removal units P include a first removal unit P1 to an Nth removal unit PN.
  • the first removal portion P1 to the Nth removal portion PN are arranged, respectively.
  • the first enlarged hole portion PA1 to the Nth enlarged hole portion PAN are formed, respectively.
  • the dimensions of the first enlarged hole PA1 to the Nth enlarged hole PAN are different from each other.
  • the dimensions of the first expanded hole portion PA1 to the Nth expanded hole portion PAN increase in the order of the first expanded hole portion PA1 to the Nth expanded hole portion PAN.
  • FIG. 13 is a diagram showing change information 80.
  • the change information 80 the fourth example of the structure of the tip end side portion 15 of the pipe portion 1 shown in FIGS. 12 (a) and 12 (b) is adopted.
  • the change information 80 includes the removal unit P to be removed from the first removal unit P1 to the Nth removal unit PN, and (B) the removal unit P.
  • the intraocular pressure after removal indicates, for example, one of the value of the intraocular pressure after removal, the amount of change in intraocular pressure after removal, or the rate of change in intraocular pressure after removal. In this embodiment, the intraocular pressure after removal indicates the rate of change in intraocular pressure.
  • the change information 80 is acquired by conducting an experiment in advance.
  • the value of (B) shown in the change information 80 may be a constant value, or may be a value having a width having an upper limit and a lower limit such as D or more and E or less. D and E are real numbers.
  • the change information 80 is a component of the implant system 100 (see FIG. 4).
  • the change information 80 is stored in a storage unit such as a USB memory and a hard disk.
  • the change information 80 is used, for example, when determining the number of removal units P to be removed in step S3 (see FIG. 10).
  • step S3 see FIG. 10
  • an example of a procedure for determining the number of removal units P to be removed using the change information 80 will be described.
  • the operator confirms the intraocular pressure measured in step S1 (see FIG. 10)
  • the operator confirms the change information 80 (see FIG. 13).
  • the surgeon removes one or two or more removal parts P from the first removal part P1 to the Nth removal part PN, which can reduce the intraocular pressure to a predetermined target value or less by removing the first removal part P1 to the Nth removal part PN.
  • Select based on change information 80.
  • the operator irradiates the selected removal unit P from the first removal unit P1 to the Nth removal unit PN with the laser light L from the irradiation unit 40.
  • the removing portion 16 selected by the operator is removed.
  • the surgeon can easily adjust the intraocular pressure so that the intraocular pressure is equal to or less than a predetermined target value.
  • a plurality of removal portions Q are provided on the tip end side portion 15 of the pipe portion 1.
  • the plurality of removal units Q are composed of a first removal unit Q1 to an Nth removal unit QN (not shown).
  • the dimensions of the first removing portion Q1 to the Nth removing portion QN are different from each other. In the present embodiment, the dimensions of the first removal unit Q1 to the Nth removal unit QN increase in the order of the first removal unit Q1 to the Nth removal unit QN.
  • step S3 the operator can reduce the intraocular pressure to a predetermined target value or less by removing one or more of the first removal unit Q1 to the Nth removal unit QN.
  • the removal unit Q is selected based on the change information 80. As a result, the surgeon can easily adjust the intraocular pressure so that the intraocular pressure is equal to or less than a predetermined target value.
  • FIG. 14A is a plan view of a fifth example of the structure of the distal end side portion 15 of the pipe portion 1.
  • 14 (b) is a side sectional view of a fifth example of the tip side portion 15 shown in FIG. 14 (a).
  • the tip side portion 15 is provided with both a removal portion P and a removal portion Q arranged around the hole portion 17.
  • FIG. 15A is a side sectional view of the pipe portion 1.
  • FIG. 15B is a side cross section of the pipe portion 1.
  • the lid portion 14 is not provided in the first opening portion 12 of the pipe portion 1.
  • the first opening 12 By opening the first opening 12, the outside of the pipe 1 and the flow path 11 inside the pipe 1 are communicated with each other.
  • the flow path 11 has aqueous humor in the anterior chamber 202 from both the first opening 12 and the hole 17. Inflows.
  • the hole portion 17 becomes the enlarged hole portion PA.
  • the amount of aqueous humor flowing into the flow path 11 is larger than that before the removal of the removal portion P.
  • the operator can adjust the intraocular pressure by selecting whether or not to remove the removed portion P.
  • the open structure of the pipe portion 1 shown in FIGS. 15 (a) and 15 (b) (the configuration in which the first opening portion 12 is opened) is the tip side portion 15 of the pipe portion 1 shown in FIG. 5 (a). It is adopted in the first example of the structure. However, the present invention is not limited to this.
  • the open structure of the pipe portion 1 has all the configurations (FIGS. 7 (a) to 9 (b), FIGS. 12 (a) to 12 (c), and FIG. 14) other than the first example shown in the present embodiment. (A), FIG. 14 (b), etc.) can be adopted.
  • the present invention is available in the field of implants and implant systems used in the treatment of the eye.

Abstract

This implant (10) can be mounted on an eye (200). The implant (10) comprises a tube part (1). A flow passage (11) of hydatoid is formed inside the tube part (1). An outer surface section (1c) of the tube part (1) is provided with a removable section (16) which is removed by being irradiated with laser light so that the outside of the tube part (1) and the flow passage (11) of the tube part (1) communicate with each other. The tube part (1) further includes a hole section (17) that communicates with the outside of the tube part (1) and the flow passage (11) of the tube part (1), and the removable section (16) may be disposed around the hole section (17).

Description

インプラント、及びインプラントシステムImplants and implant systems
　本発明は、インプラント、及びインプラントシステムに関する。 The present invention relates to an implant and an implant system.
　特許文献１に記載のインプラントは、眼に装着可能である。インプラントは、管部と、絞り部とを備える。管部の内部には、房水の流路が形成される。絞り部は、流路に配置される。絞り部は、流路に配置される壁部と、壁部を貫通する孔部とを含む。レーザー光は、管部を透過して、管部の内部に配置される壁部に照射される。壁部は、レーザー光を照射されることで流路から除去される。壁部が除去されることで、眼圧が調整される。 The implant described in Patent Document 1 can be attached to the eye. The implant comprises a tube portion and a throttle portion. Aqueous humor flow path is formed inside the pipe portion. The throttle portion is arranged in the flow path. The throttle portion includes a wall portion arranged in the flow path and a hole portion penetrating the wall portion. The laser beam passes through the tube portion and irradiates the wall portion arranged inside the tube portion. The wall portion is removed from the flow path by being irradiated with laser light. By removing the wall, the intraocular pressure is adjusted.
特開２０１９―０７６３０４JP-A-2019-073304
　しかし、管部の内部に絞り部を配置するため、インプラントの構造が複雑になる可能性があった。 However, since the squeezed part is placed inside the tube part, the structure of the implant may be complicated.
　本発明は、上記課題に鑑みてなされたものであり、簡素な構造で眼圧を調整できるインプラント、及びインプラントシステムを提供することを目的としている。 The present invention has been made in view of the above problems, and an object of the present invention is to provide an implant capable of adjusting intraocular pressure with a simple structure and an implant system.
　本開示の第１の態様は、インプラントを対象とする。インプラントは、眼に装着可能である。インプラントは、内部に房水の流路が形成される管部を備え、前記管部の外面部には、レーザー光を照射されることで前記管部の外部と前記管部の流路とを連通するように除去される除去部が設けれる。 The first aspect of the present disclosure is intended for implants. The implant can be attached to the eye. The implant includes a tube portion in which a flow path of aqueous humor is formed inside, and the outer surface portion of the tube portion is irradiated with laser light to provide an outside of the tube portion and a flow path of the tube portion. A removing portion is provided to be removed so as to communicate.
　本開示の第２の態様は、第１の態様において、前記管部は、前記管部の外部と前記管部の流路とを連通する孔部をさらに含み、前記除去部は、前記孔部の周囲に配置される。 A second aspect of the present disclosure is, in the first aspect, the pipe portion further includes a hole portion communicating the outside of the pipe portion and the flow path of the pipe portion, and the removal portion is the hole portion. Placed around.
　本開示の第３の態様は、第１の態様又は第２の態様において、前記管部は、前記インプラントが前記眼に装着された状態で、前記眼の前房に配置される先端側部分を含み、前記除去部は、前記先端側部分に配置される。 A third aspect of the present disclosure is, in the first or second aspect, the tubular portion having an distal end portion placed in the anterior chamber of the eye with the implant attached to the eye. Including, the removing portion is arranged on the tip side portion.
　本開示の第４の態様は、第１の態様～第３の態様のうちのいずれか１つにおいて、前記インプラントが前記眼に装着された状態で、前記除去部は前記眼の前房に配置される。 A fourth aspect of the present disclosure is, in any one of the first to third aspects, the implant is attached to the eye and the removal portion is placed in the anterior chamber of the eye. Will be done.
　本開示の第５の態様は、第１の態様～第４の態様のうちのいずれか１つにおいて、前記インプラントが前記眼に装着された状態で、前記除去部は前記眼の角膜の奥側に配置される。 A fifth aspect of the present disclosure is, in any one of the first to fourth aspects, in a state where the implant is attached to the eye, the removal portion is the back side of the cornea of the eye. Is placed in.
　本開示の第６の態様は、第１の態様～第５の態様のうちのいずれか１つにおいて、前記除去部は、前記眼の角膜を透過する前記レーザー光を照射されることで除去される。 A sixth aspect of the present disclosure is, in any one of the first to fifth aspects, the removing portion being removed by irradiating the laser beam passing through the cornea of the eye. To.
　本開示の第７の態様は、第１の態様～第６の態様のうちのいずれか１つにおいて、前記管部には、複数の前記除去部が配置される。 In the seventh aspect of the present disclosure, in any one of the first to sixth aspects, a plurality of the removing portions are arranged in the pipe portion.
　本開示の第８の態様は、第７の態様において、前記複数の除去部は、互いに異なる寸法を有する。 In the eighth aspect of the present disclosure, in the seventh aspect, the plurality of removing portions have different dimensions from each other.
　本開示の第９の態様は、インプラントシステムを対象とする。インプラントシステムは、上記インプラントと、前記レーザー光を照射する照射部と、眼圧を計測する計測部とを備える。 The ninth aspect of the present disclosure is intended for implant systems. The implant system includes the implant, an irradiation unit that irradiates the laser beam, and a measurement unit that measures intraocular pressure.
　本発明のインプラントは、簡素な構造で眼圧を調整できる。 The implant of the present invention can adjust intraocular pressure with a simple structure.
本発明の実施形態に係るインプラントの斜視図である。It is a perspective view of the implant which concerns on embodiment of this invention. 図１のＩＩ―ＩＩ断面図である。FIG. 2 is a sectional view taken along line II-II of FIG. 眼に装着された状態のインプラントを示す模式的断面図である。It is a schematic cross-sectional view which shows the implant in the state of being attached to an eye. 図３の一部拡大図である。It is a partially enlarged view of FIG. （ａ）は、管部の先端側部分の第１例の平面図である。（ｂ）は、（ａ）に示す先端側部分の第１例の側面断面図である。(A) is a plan view of the first example of the tip end side portion of the pipe portion. (B) is a side sectional view of the first example of the tip side portion shown in (a). （ａ）は、除去部の除去後の管部の先端側部分の平面図である。（ｂ）は、図６（ａ）の側面断面図である。(A) is a plan view of the tip end side portion of the pipe portion after the removal portion is removed. (B) is a side sectional view of FIG. 6 (a). （ａ）は、先端側部分の第２例の平面図である。（ｂ）は、図７（ａ）に示す先端側部分の第２例の側面断面図である。(A) is a plan view of the second example of the tip side portion. (B) is a side sectional view of the second example of the tip side portion shown in FIG. 7 (a). （ａ）は、除去部の除去後の先端側部分を示す平面図である。（ｂ）は、除去部の除去後の先端側部分を示す断面図である。(A) is a plan view which shows the tip side part after removal of the removal part. (B) is a cross-sectional view showing a tip side portion after removal of the removed portion. （ａ）は、先端側部分の第３例の平面図である。（ｂ）は、図９（ａ）に示す先端側部分１５の第３例の側面断面図である。(A) is a plan view of the third example of the tip side portion. (B) is a side sectional view of a third example of the tip end side portion 15 shown in FIG. 9 (a). インプラントが装着された眼の眼圧を調整する手順を示すフローチャートである。It is a flowchart which shows the procedure which adjusts the intraocular pressure of the eye which attached the implant. 板部を有しないインプラントを示す模式的断面図である。It is a schematic cross-sectional view which shows the implant which does not have a plate part. （ａ）は、管部の先端側部分の構造の第４例の平面図である。（ｂ）は、図１２（ａ）に示す先端側部分の第４例の側面断面図である。（ｃ）は、複数の除去部の除去後の管部の先端側部分の平面図である。(A) is a plan view of the fourth example of the structure of the tip end side portion of the pipe portion. (B) is a side sectional view of the fourth example of the tip side portion shown in FIG. 12 (a). (C) is a plan view of the tip end side portion of the pipe portion after removal of the plurality of removed portions. 変化情報を示す図である。It is a figure which shows the change information. （ａ）は、管部の先端側部分の構造の第５例の平面図である。（ｂ）は、図１４（ａ）に示す先端側部分の第５例の側面断面図である。(A) is a plan view of the fifth example of the structure of the tip end side portion of the pipe portion. (B) is a side sectional view of the fifth example of the tip side portion shown in FIG. 14 (a). （ａ）は、管部の変形例の側面断面図である。（ｂ）は、管部の変形例の側面断面である。(A) is a side sectional view of a modified example of a pipe portion. (B) is a side sectional view of a modified example of the pipe portion.
　本発明の実施形態について、図面を参照しながら説明する。なお、図中、同一又は相当部分については同一の参照符号を付して説明を繰り返さない。 An embodiment of the present invention will be described with reference to the drawings. In the figure, the same or corresponding parts are designated by the same reference numerals and the description is not repeated.
　図１、及び図２を参照して、本発明の実施形態であるインプラント１０について説明する。図１は、インプラント１０の斜視図である。図２は、図１のＩＩ―ＩＩ断面図である。 The implant 10 according to the embodiment of the present invention will be described with reference to FIGS. 1 and 2. FIG. 1 is a perspective view of the implant 10. FIG. 2 is a sectional view taken along line II-II of FIG.
　図１、及び図２に示すように、インプラント１０は、緑内障の治療に用いられる。インプラント１０は、眼に装着可能である。インプラント１０が眼に装着されると、眼から房水が流出することをインプラント１０が促進させる。その結果、眼圧の異常な上昇を抑えることが可能になる。 As shown in FIGS. 1 and 2, the implant 10 is used for the treatment of glaucoma. The implant 10 can be attached to the eye. When the implant 10 is attached to the eye, the implant 10 promotes the outflow of aqueous humor from the eye. As a result, it becomes possible to suppress an abnormal increase in intraocular pressure.
　インプラント１０は、管部１と、板部３とを含む。 The implant 10 includes a tube portion 1 and a plate portion 3.
　管部１は、管状の形状を有する。つまり、管部１は、中空の形状を有する。管部１は、柔軟性、可撓性、及び／又は、弾性を有する。管部１は、例えば、シリコーン、エラストマー樹脂、又は、弾性を有する樹脂材料で形成される。本実施形態の管部１は、シリコーン製のチューブである。 The tube portion 1 has a tubular shape. That is, the pipe portion 1 has a hollow shape. The tube portion 1 has flexibility, flexibility, and / or elasticity. The tube portion 1 is formed of, for example, silicone, an elastomer resin, or an elastic resin material. The tube portion 1 of the present embodiment is a silicone tube.
　管部１は、第１端部１ａと、第２端部１ｂとを有する。管部１は、第１端部１ａから第２端部１ｂに向かって延びる長手の形状を有する。管部１の内部には、房水の流路１１が形成される。流路１１は、管部１の内面で囲まれた空間を示す。流路１１は、例えば、約０．５ｍｍの内径を有する。 The pipe portion 1 has a first end portion 1a and a second end portion 1b. The pipe portion 1 has a long shape extending from the first end portion 1a toward the second end portion 1b. Aqueous humor flow path 11 is formed inside the pipe portion 1. The flow path 11 indicates a space surrounded by the inner surface of the pipe portion 1. The flow path 11 has, for example, an inner diameter of about 0.5 mm.
　管部１は、眼で生成された房水を、流路１１を通じて眼の外部に案内する。管部１は、第１開口部１２と、第２開口部１３とを含む。管部１の両端部は、第１開口部１２と第２開口部１３とによって開放されている。第１開口部１２は、第１端部１ａに形成される。第１開口部１２は、流路１１と管部１の外部とを連通する。第２開口部１３は、第２端部１ｂに形成される。第２開口部１３は、流路１１と管部１の外部とを連通する。管部１は、第１開口部１２を介して流路１１に流入した房水を、第２開口部１３を介して流路１１から排出する。 The tube portion 1 guides the aqueous humor generated by the eye to the outside of the eye through the flow path 11. The pipe portion 1 includes a first opening portion 12 and a second opening portion 13. Both ends of the pipe portion 1 are opened by the first opening portion 12 and the second opening portion 13. The first opening 12 is formed at the first end 1a. The first opening 12 communicates the flow path 11 with the outside of the pipe portion 1. The second opening 13 is formed at the second end 1b. The second opening 13 communicates the flow path 11 with the outside of the pipe portion 1. The pipe portion 1 discharges the aqueous humor that has flowed into the flow path 11 through the first opening 12 from the flow path 11 through the second opening 13.
　管部１は、蓋部１４と、先端側部分１５と、除去部１６とをさらに含む。本実施形態では、蓋部１４は、管部１と別体の部材であり、第１端部１ａに固定され、第１開口部１２を閉塞する（図５（ｂ）参照）。なお、蓋部１４は、管部１と一体の部材であり、管部１の先端側部分１５が第１開口部１２を有しておらず、先端側部分１５が元から蓋部１４で閉塞されていてもよい。管部１は、第１の構造と、第２の構造とを有する。第１の構造は、蓋部１４が管部１と一体に構成される構造、及び、別体に構成される構造のうちのいずれかの構造を示す。第２の構造は、管部１の先端側部分１５が第１開口部１２を有する構造、及び、第１開口部１２を有しない構造のうちのいずれかの構造を示す。先端側部分１５は、管部１のうち第１開口部１２側に位置する部分を示す。除去部１６は、管部１の外面部１ｃに設けられる。除去部１６は、管部１の先端側部分１５に配置される。除去部１６は、管部１から除去されることで、管部１の外部と管部１の流路１１とを連通する。 The pipe portion 1 further includes a lid portion 14, a tip side portion 15, and a removal portion 16. In the present embodiment, the lid portion 14 is a member separate from the pipe portion 1, is fixed to the first end portion 1a, and closes the first opening portion 12 (see FIG. 5B). The lid portion 14 is a member integrated with the pipe portion 1, the tip end side portion 15 of the pipe portion 1 does not have the first opening portion 12, and the tip end side portion 15 is originally closed by the lid portion 14. It may have been done. The pipe portion 1 has a first structure and a second structure. The first structure shows either a structure in which the lid portion 14 is integrally formed with the pipe portion 1 or a structure in which the lid portion 14 is formed separately. The second structure shows either a structure in which the distal end side portion 15 of the pipe portion 1 has the first opening portion 12 or a structure in which the tip end side portion 15 does not have the first opening portion 12. The tip end side portion 15 indicates a portion of the pipe portion 1 located on the first opening 12 side. The removing portion 16 is provided on the outer surface portion 1c of the pipe portion 1. The removing portion 16 is arranged on the tip end side portion 15 of the pipe portion 1. The removing portion 16 communicates with the outside of the pipe portion 1 and the flow path 11 of the pipe portion 1 by being removed from the pipe portion 1.
　板部３は、プレート状の形状を有する。板部３の平面視形状は、例えば、円形状、楕円形状、又は、角部が曲線となった四角形状である。 The plate portion 3 has a plate-like shape. The plan view shape of the plate portion 3 is, for example, a circular shape, an elliptical shape, or a square shape having curved corners.
　板部３は、主表面３１と、本体部３２とを有する。板部３の主表面３１は、本体部３２に形成される。板部３の主表面３１の面積は、例えば、１００平方ミリメートル以上６００平方ミリメートル以下である。板部３の主表面３１は、眼球の表面に沿った曲面形状を有する。板部３の主表面３１の曲率半径は例えば１２ミリメートル以上１４ミリメートル以下である。板部３の厚さは、例えば、０．５ミリメートル以上２ミリメートル以下である。 The plate portion 3 has a main surface 31 and a main body portion 32. The main surface 31 of the plate portion 3 is formed on the main body portion 32. The area of the main surface 31 of the plate portion 3 is, for example, 100 square millimeters or more and 600 square millimeters or less. The main surface 31 of the plate portion 3 has a curved surface shape along the surface of the eyeball. The radius of curvature of the main surface 31 of the plate portion 3 is, for example, 12 mm or more and 14 mm or less. The thickness of the plate portion 3 is, for example, 0.5 mm or more and 2 mm or less.
　板部３は、例えば、柔軟性、可撓性、又は、弾性を有する材料により形成される。具体的には、板部３は、例えば、シリコンエラストマーを含む材料により形成される。その結果、インプラント１０が眼に装着された状態で、眼球の表面に沿った曲面形状に板部３を変形させることが可能になる。 The plate portion 3 is formed of, for example, a material having flexibility, flexibility, or elasticity. Specifically, the plate portion 3 is formed of, for example, a material containing a silicon elastomer. As a result, it becomes possible to deform the plate portion 3 into a curved surface shape along the surface of the eyeball while the implant 10 is attached to the eye.
　板部３には、管部１が固定される。詳細には、板部３には、管部１の第２端部１ｂが固定される。管部１の第２端部１ｂは、板部３（本体部３２）の上部に配置される。これに対し、管部１の第１端部１ａは、板部３の外方に位置する。 The pipe portion 1 is fixed to the plate portion 3. Specifically, the second end portion 1b of the pipe portion 1 is fixed to the plate portion 3. The second end portion 1b of the pipe portion 1 is arranged on the upper portion of the plate portion 3 (main body portion 32). On the other hand, the first end portion 1a of the pipe portion 1 is located on the outer side of the plate portion 3.
　板部３は、膨出部３３と、縫合孔３４と、凸部３５と、複数の貫通孔３６と、挿通孔３７とをさらに有する。膨出部３３は、本体部３２から膨出する。縫合孔３４は、膨出部３３に形成される。縫合孔３４は、膨出部３３を貫通する。 The plate portion 3 further has a bulging portion 33, a suture hole 34, a convex portion 35, a plurality of through holes 36, and an insertion hole 37. The bulging portion 33 bulges from the main body portion 32. The suture hole 34 is formed in the bulge 33. The suture hole 34 penetrates the bulge 33.
　凸部３５は、本体部３２から上方に突出する形状を有する。凸部３５と本体部３２との間には、挿通孔３７が形成される。挿通孔３７には、管部１が挿通される。管部１は、挿通孔３７に挿通された状態で、本体部３２に固定される。詳細には、管部１の第２端部１ｂは、挿通孔３７に挿通された状態で、本体部３２に固定される。 The convex portion 35 has a shape protruding upward from the main body portion 32. An insertion hole 37 is formed between the convex portion 35 and the main body portion 32. The pipe portion 1 is inserted into the insertion hole 37. The pipe portion 1 is fixed to the main body portion 32 in a state of being inserted into the insertion hole 37. Specifically, the second end portion 1b of the pipe portion 1 is fixed to the main body portion 32 in a state of being inserted into the insertion hole 37.
　複数の貫通孔３６の各々は、板部３を貫通する。詳細には、複数の貫通孔３６の各々は、板部３の本体部３２を貫通する。 Each of the plurality of through holes 36 penetrates the plate portion 3. Specifically, each of the plurality of through holes 36 penetrates the main body portion 32 of the plate portion 3.
　次に、図３及び図４を参照して、眼２００に装着された状態のインプラント１０について説明する。図３は、眼２００に装着された状態のインプラント１０を示す模式的断面図である。図４は、図３の一部拡大図である。 Next, the implant 10 in a state of being attached to the eye 200 will be described with reference to FIGS. 3 and 4. FIG. 3 is a schematic cross-sectional view showing the implant 10 in a state of being attached to the eye 200. FIG. 4 is a partially enlarged view of FIG.
　図３及び図４に示すように、板部３は、強膜２０１とテノン嚢２０３との間に挿入される。板部３の縫合孔３４（図１参照）には、縫合糸が挿通される。縫合糸は、縫合孔３４に挿通されて、板部３と強膜２０１とを縫合する。その結果、板部３が強膜２０１に固定される。 As shown in FIGS. 3 and 4, the plate portion 3 is inserted between the sclera 201 and the tenon sac 203. A suture thread is inserted into the suture hole 34 (see FIG. 1) of the plate portion 3. The suture is inserted through the suture hole 34 and sutures the plate portion 3 and the sclera 201. As a result, the plate portion 3 is fixed to the sclera 201.
　板部３が強膜２０１に固定された後に、ある程度の期間が経過すると、眼内の生体組織が成長する。そして、眼内の生体組織が複数の貫通孔３６（図１参照）の各々を通ってテノン嚢２０３と強膜２０１との間を連結する。その結果、眼内での板部３の位置がずれることが抑制され、眼内での板部３の位置が安定する。 After a certain period of time has passed after the plate 3 is fixed to the sclera 201, the biological tissue in the eye grows. Then, the biological tissue in the eye connects between the tenon sac 203 and the sclera 201 through each of the plurality of through holes 36 (see FIG. 1). As a result, the position of the plate portion 3 in the eye is suppressed from being displaced, and the position of the plate portion 3 in the eye is stabilized.
　板部３が存在することにより、人体の反応として板部３の周囲にブレブ２０４が形成される。板部３が存在し続けることによりブレブ２０４も形成され続ける。その結果、板部３はブレブ２０４内で浮遊する。ブレブ２０４は、小胞、小水胞、及び／又は、小気胞を示す。 Due to the presence of the plate portion 3, a bleb 204 is formed around the plate portion 3 as a reaction of the human body. As the plate portion 3 continues to exist, the bleb 204 also continues to be formed. As a result, the plate portion 3 floats in the bleb 204. Bleb 204 indicates vesicles, vesicles, and / or vesicles.
　管部１は、板部３から強膜２０１に沿いつつ、前房２０２側に向かって延びる。管部１の第１端部１ａは、強膜２０１、線維柱帯２０９及びシュレム管２１０を貫通して、前房２０２内に挿入される。なお、管部１の第１端部１ａが、前房２０２内に挿入される際、第１端部１ａの貫通する対象は特に限定されない。例えば、管部１は、前房２０２内に挿入される際、角膜２１１に隣接する領域２０５を貫通してもよい。また、本実施形態では、管部１の第１端部１ａは、前房２０２内に挿入されたが、本発明はこれに限定されない。管部１の第１端部１ａは、例えば、毛様体扁平部に挿入されてもよい。 The tube portion 1 extends from the plate portion 3 along the sclera 201 toward the anterior chamber 202 side. The first end 1a of the duct 1 penetrates the sclera 201, trabecular meshwork 209 and Schlemm's canal 210 and is inserted into the anterior chamber 202. When the first end portion 1a of the tube portion 1 is inserted into the anterior chamber 202, the target through which the first end portion 1a penetrates is not particularly limited. For example, the tube portion 1 may penetrate the region 205 adjacent to the cornea 211 when inserted into the anterior chamber 202. Further, in the present embodiment, the first end portion 1a of the tube portion 1 is inserted into the anterior chamber 202, but the present invention is not limited thereto. The first end portion 1a of the tube portion 1 may be inserted into, for example, the pars plana portion of the ciliary body.
　インプラント１０が眼２００に装着された状態で、管部１の第２開口部１３は、強膜２０１とテノン嚢２０３との間に配置される。 With the implant 10 attached to the eye 200, the second opening 13 of the tube portion 1 is placed between the sclera 201 and the tenon sac 203.
　強膜２０１と、結膜２０６との間には、テノン嚢２０３が配置される。インプラント１０が眼２００に装着された状態で、管部１は、テノン嚢２０３の下方を通るように配置される。なお、インプラント１０が眼２００に装着された状態で、管部１が、テノン嚢２０３の上方を通るように配置されてもよい。 A tenon sac 203 is placed between the sclera 201 and the conjunctiva 206. With the implant 10 attached to the eye 200, the tube 1 is placed so as to pass below the tenon sac 203. In addition, the tube portion 1 may be arranged so as to pass above the tenon sac 203 with the implant 10 attached to the eye 200.
　インプラント１０が眼２００に装着された状態で、管部１の先端側部分１５及び除去部１６（図１及び図２参照）は、前房２０２（前房２０２内）に配置される。また、インプラント１０が眼２００に装着された状態で、管部１の先端側部分１５及び除去部１６は、角膜２１１の奥側に配置される。奥側は、眼２００の内部側を示す。 With the implant 10 attached to the eye 200, the distal end side portion 15 and the removal portion 16 (see FIGS. 1 and 2) of the tube portion 1 are arranged in the anterior chamber 202 (inside the anterior chamber 202). Further, with the implant 10 attached to the eye 200, the distal end side portion 15 and the removal portion 16 of the tube portion 1 are arranged on the inner side of the cornea 211. The back side shows the inner side of the eye 200.
　管部１の除去部１６（図１及び図２参照）は、照射部４０からレーザー光Ｌを照射されることによって除去される。レーザー光Ｌは、角膜２１１を透過して、除去部１６に照射される。この場合、術者は、例えば、顕微鏡を用いて除去部１６の位置を確認しながら、照射部４０を操作して、除去部１６に対するレーザー光Ｌの照射を行う。 The removing portion 16 (see FIGS. 1 and 2) of the tube portion 1 is removed by irradiating the irradiation unit 40 with the laser beam L. The laser beam L passes through the cornea 211 and irradiates the removing portion 16. In this case, the operator operates the irradiation unit 40 while confirming the position of the removal unit 16 using a microscope, for example, to irradiate the removal unit 16 with the laser beam L.
　レーザー光Ｌは、例えば、緑色レーザー、黄色レーザー、赤色レーザー、ＹＡＧレーザー、又は、半導体レーザーである。レーザー光Ｌは、例えば、比較的波長が長く、深達度が高い。照射部４０は、例えば、マルチカラーレーザー光凝固装置、グリーンレーザー光凝固装置、ＹＡＧレーザー手術装置、又は、半導体レーザー装置を含む。 The laser light L is, for example, a green laser, a yellow laser, a red laser, a YAG laser, or a semiconductor laser. The laser beam L has a relatively long wavelength and a high depth of penetration, for example. The irradiation unit 40 includes, for example, a multi-color laser photocoagulation device, a green laser photocoagulation device, a YAG laser surgery device, or a semiconductor laser device.
　図１、図２、及び図４に示すように、除去部１６は、所定の色を有する。所定の色は、レーザー光Ｌを吸収できる色であり、例えば、黒色、又は、茶色のような濃い色である。 As shown in FIGS. 1, 2, and 4, the removing portion 16 has a predetermined color. The predetermined color is a color that can absorb the laser beam L, and is, for example, a dark color such as black or brown.
　例えば、管部１の先端側部分１５が透明又は半透明の色（レーザー光Ｌを透過するような色）を有する場合、除去部１６は、先端側部分１５の一部又は全部に、黒色又は茶色のような濃い色を着色することによって形成される。 For example, when the distal end side portion 15 of the tube portion 1 has a transparent or translucent color (a color that transmits the laser beam L), the removing portion 16 may be black or entirely on the distal end side portion 15. It is formed by coloring a dark color such as brown.
　先端側部分１５のうちの除去部１６以外の部分よりも、除去部１６が濃い色を有することで、術者が照射部４０を操作して、除去部１６に対するレーザー光Ｌの照射を行う際に、除去部１６を容易に確認することができる。 When the removing portion 16 has a darker color than the portion of the tip side portion 15 other than the removing portion 16, the operator operates the irradiation unit 40 to irradiate the removing portion 16 with the laser beam L. In addition, the removed portion 16 can be easily confirmed.
　除去部１６は、レーザー光Ｌを照射されると、レーザー光Ｌを吸収する。その結果、レーザー光Ｌのエネルギーにより除去部１６が焼失されて、管部１から除去される。 When the removing unit 16 is irradiated with the laser light L, the removing unit 16 absorbs the laser light L. As a result, the removing portion 16 is burnt down by the energy of the laser beam L and removed from the tube portion 1.
　なお、除去部１６の色及び材料は特に限定されない。除去部１６は、レーザー光Ｌにより除去される構成を有していればよい。除去部１６と、先端側部分１５のうちの除去部１６以外の部分とは、同じ色で形成されていてもよく、又は、異なる色で形成されていてもよい。また、除去部１６と、先端側部分１５のうちの除去部１６以外の部分とは、同じ材料で形成されていてもよく、又は、異なる材料で形成されていてもよい。なお、除去部１６は、レーザー光Ｌ（例えば、ＹＡＧレーザー）を照射されることで破壊されて、管部１から除去されるような材料で形成されていてもよい。 The color and material of the removal unit 16 are not particularly limited. The removing unit 16 may have a configuration in which it is removed by the laser beam L. The removing portion 16 and the portion of the tip side portion 15 other than the removing portion 16 may be formed in the same color or may be formed in different colors. Further, the removing portion 16 and the portion of the tip side portion 15 other than the removing portion 16 may be formed of the same material or may be formed of different materials. The removing portion 16 may be made of a material that is destroyed by being irradiated with the laser beam L (for example, a YAG laser) and is removed from the tube portion 1.
　続いて、図３及び図４を参照して、インプラント１０の機能について説明する。 Subsequently, the function of the implant 10 will be described with reference to FIGS. 3 and 4.
　図３において、一点鎖線の矢印は、房水の流れを示す。図３に示すように、房水は毛様体２０７によって生成される。房水は、水晶体２０８の前方において、瞳孔を通じて眼２００の前房２０２へと循環して栄養を供給する。正常な眼２００では、房水は線維柱帯２０９、シュレム管２１０を通じて眼球外へと排出される。しかし、緑内障の患者の場合、例えば、線維柱帯２０９の詰まりによって房水の適切な排出が妨げられる。その結果、眼圧が正常な範囲を超えて上昇する。眼圧が異常に上昇すると、例えば、圧力により視神経がダメージを受けて視野や視力に障害が発生する。 In FIG. 3, the alternate long and short dash arrow indicates the flow of aqueous humor. As shown in FIG. 3, the aqueous humor is produced by the ciliary body 207. Aqueous humor circulates in front of the crystalline lens 208 through the pupil to the anterior chamber 202 of the eye 200 to nourish. In a normal eye 200, the aqueous humor is drained out of the eye through the trabecular meshwork 209 and Schlemm's canal 210. However, in the case of glaucoma patients, for example, clogging of the trabecular meshwork 209 prevents proper drainage of aqueous humor. As a result, intraocular pressure rises beyond the normal range. When the intraocular pressure rises abnormally, for example, the pressure damages the optic nerve and impairs the visual field and visual acuity.
　インプラント１０が眼２００に装着されると、ブレブ２０４が形成される。また、前房２０２内の房水は、管部１の流路１１に流入し、流路１１を通じて流れた後、ブレブ２０４内に供給される。、ブレブ２０４内に供給された房水は、ブレブ２０４の周囲から生体組織内に浸透していく。従って、前房２０２内の房水が流路１１を介して眼外に排出される。その結果、眼圧の異常な上昇を抑制することが可能になる。なお、ブレブ２０４は必ず形成されるわけではない。例えば、管部１の第２開口部１３を眼２００の後ろ側に配置することで、ブレブ２０４が形成されることなく、管部１の第２開口部１３から排出された房水が生体組織内に浸透していく。 When the implant 10 is attached to the eye 200, a bleb 204 is formed. Further, the aqueous humor in the anterior chamber 202 flows into the flow path 11 of the pipe portion 1, flows through the flow path 11, and then is supplied into the bleb 204. , The aqueous humor supplied into the bleb 204 permeates into the living tissue from the periphery of the bleb 204. Therefore, the aqueous humor in the anterior chamber 202 is discharged to the outside of the eye through the flow path 11. As a result, it becomes possible to suppress an abnormal increase in intraocular pressure. The bleb 204 is not always formed. For example, by arranging the second opening 13 of the tube 1 behind the eye 200, the aqueous humor discharged from the second opening 13 of the tube 1 is a biological tissue without forming the bleb 204. It penetrates inside.
　―管部１の先端側部分１５の構造の第１例―
　次に、図５（ａ）～図６（ｂ）を参照して、管部１の先端側部分１５（図１及び図２参照）の構造の第１例について説明する。図５（ａ）は、管部１の先端側部分１５の第１例の平面図である。図５（ｂ）は、図５（ａ）に示す先端側部分１５の第１例の側面断面図である。 -First example of the structure of the tip end side portion 15 of the pipe portion 1-
Next, a first example of the structure of the tip end side portion 15 (see FIGS. 1 and 2) of the pipe portion 1 will be described with reference to FIGS. 5 (a) to 6 (b). FIG. 5A is a plan view of the first example of the tip end side portion 15 of the pipe portion 1. 5 (b) is a side sectional view of the first example of the tip side portion 15 shown in FIG. 5 (a).
　図５（ａ）及び図５（ｂ）に示すように、管部１は、孔部１７を含む。孔部１７は、管部１の外部と管部１の流路１１とを連通する。 As shown in FIGS. 5 (a) and 5 (b), the pipe portion 1 includes a hole portion 17. The hole portion 17 communicates the outside of the pipe portion 1 with the flow path 11 of the pipe portion 1.
　除去部Ｐは、除去部１６の第１例である。除去部Ｐは、孔部１７の周囲に配置される。除去部Ｐが孔部１７の周囲に配置されることは、除去部Ｐが孔部１７の縁部１７ａの全部又は一部に接するように配置されることを示す。第１例では、除去部Ｐは、孔部１７の縁部１７ａの全部に接しており、孔部１７の縁部１７ａに沿って環状に形成される。なお、孔部１７及び除去部Ｐの形状は特に限定されない。 The removal unit P is the first example of the removal unit 16. The removing portion P is arranged around the hole portion 17. The fact that the removing portion P is arranged around the hole portion 17 indicates that the removing portion P is arranged so as to be in contact with all or a part of the edge portion 17a of the hole portion 17. In the first example, the removing portion P is in contact with the entire edge portion 17a of the hole portion 17, and is formed in an annular shape along the edge portion 17a of the hole portion 17. The shapes of the hole 17 and the removal P are not particularly limited.
　図４～図６（ｂ）を参照して、管部１の先端側部分１５から除去部Ｐが除去される手順について説明する。図６（ａ）は、除去部Ｐの除去後の管部１の先端側部分１５の平面図である。図６（ｂ）は、図６（ａ）の側面断面図である。 A procedure for removing the removing portion P from the tip end side portion 15 of the pipe portion 1 will be described with reference to FIGS. 4 to 6 (b). FIG. 6A is a plan view of the tip end side portion 15 of the pipe portion 1 after the removal portion P is removed. 6 (b) is a side sectional view of FIG. 6 (a).
　図４～図５（ｂ）に示すように、除去部Ｐの除去前において、前房２０２内の房水が孔部１７を通じて流路１１に流入している。流路１１に流入した房水は、第２開口部１３側へ流れて、第２開口部１３から排出される（図３参照）。この状態で、照射部４０から除去部Ｐに向けてレーザー光Ｌが照射される。これにより、除去部Ｐが除去される。除去部Ｐは、管部１の外部と管部１の流路１１とを連通するように除去される。 As shown in FIGS. 4 to 5 (b), before the removal of the removal portion P, the aqueous humor in the anterior chamber 202 flows into the flow path 11 through the hole portion 17. The aqueous humor that has flowed into the flow path 11 flows toward the second opening 13 and is discharged from the second opening 13 (see FIG. 3). In this state, the laser beam L is irradiated from the irradiation unit 40 toward the removal unit P. As a result, the removing portion P is removed. The removing portion P is removed so as to communicate the outside of the pipe portion 1 with the flow path 11 of the pipe portion 1.
　図６（ａ）及び図６（ｂ）に示すように、除去部Ｐが除去されると、除去部Ｐが存在していた場所には、空所Ｐａが形成される。空所Ｐａは、孔部１７と連続するように形成される。これにより、管部１の先端側部分１５には、孔部１７と空所Ｐａとが合わさった拡大孔部ＰＡが形成される。拡大孔部ＰＡの断面積は、孔部１７の断面積よりも大きい。拡大孔部ＰＡの断面積、及び孔部１７の断面積は、孔部１７の軸に対して垂直な断面の面積を示す。 As shown in FIGS. 6 (a) and 6 (b), when the removed portion P is removed, a vacant space Pa is formed in the place where the removed portion P was present. The vacant space Pa is formed so as to be continuous with the hole 17. As a result, in the tip end side portion 15 of the pipe portion 1, an enlarged hole portion PA in which the hole portion 17 and the vacant space Pa are combined is formed. The cross-sectional area of the enlarged hole PA is larger than the cross-sectional area of the hole 17. The cross-sectional area of the enlarged hole PA and the cross-sectional area of the hole 17 indicate the area of the cross section perpendicular to the axis of the hole 17.
　拡大孔部ＰＡは、図６（ａ）及び図６（ｂ）に示す孔部１７を、空所Ｐａの分だけ拡大させた形状を有する。拡大孔部ＰＡは、孔部１７を拡大させた形状を有することで、孔部１７よりも多くの量の房水を、前房２０２から流路１１へ流入させることができる。流路１１へ流入する房水の量が多くなる程、眼圧の低下の程度が大きくなる。なお、流路１１へ流入する房水の量は、詳細には、流路１１へ流入する単位時間当たりの房水の量を示す。 The enlarged hole PA has a shape in which the hole 17 shown in FIGS. 6 (a) and 6 (b) is enlarged by the amount of the empty space Pa. Since the enlarged hole PA has an enlarged shape of the hole 17, a larger amount of aqueous humor than the hole 17 can flow from the anterior chamber 202 into the flow path 11. As the amount of aqueous humor flowing into the flow path 11 increases, the degree of decrease in intraocular pressure increases. The amount of aqueous humor flowing into the flow path 11 indicates, in detail, the amount of aqueous humor flowing into the flow path 11 per unit time.
　術者は、除去部Ｐを除去することによって、眼圧を調整することができる。 The surgeon can adjust the intraocular pressure by removing the removal portion P.
　以上、図１～図６（ｂ）を参照して説明したように、管部１の外面部１ｃには、除去部Ｐが設けられる。除去部Ｐは、レーザー光Ｌを照射されることで管部１の外部と管部１の流路１１とを連通するように除去される。除去部Ｐが除去されると、拡大孔部ＰＡが形成される。これにより、前房２０２から管部１に流入する房水の量が増大するので、眼圧が低下する。その結果、インプラント１０は、管部１の外面部１ｃに除去部Ｐを設けるという簡素な構造で、眼圧を調整できる。 As described above with reference to FIGS. 1 to 6 (b), the removal portion P is provided on the outer surface portion 1c of the pipe portion 1. The removing portion P is removed so as to communicate the outside of the tube portion 1 with the flow path 11 of the tube portion 1 by being irradiated with the laser beam L. When the removing portion P is removed, the enlarged hole portion PA is formed. As a result, the amount of aqueous humor flowing from the anterior chamber 202 into the tube portion 1 increases, so that the intraocular pressure decreases. As a result, the implant 10 can adjust the intraocular pressure with a simple structure in which the removal portion P is provided on the outer surface portion 1c of the tube portion 1.
　―管部１の先端側部分１５の構造の第２例―
　図４、図７（ａ）～図８（ｂ）を参照して、管部１の先端側部分１５の構造の第２例について説明する。図７（ａ）は、先端側部分１５の第２例の平面図である。図７（ｂ）は、図７（ａ）に示す先端側部分１５の第２例の側面断面図である。 -A second example of the structure of the tip end side portion 15 of the pipe portion 1-
A second example of the structure of the distal end side portion 15 of the pipe portion 1 will be described with reference to FIGS. 4 and 7 (a) to 8 (b). FIG. 7A is a plan view of the second example of the tip end side portion 15. FIG. 7B is a side sectional view of a second example of the tip end side portion 15 shown in FIG. 7A.
　図７（ａ）及び図７（ｂ）に示すように、除去部Ｑは、除去部１６の第２例である。除去部Ｑは、管部１の先端側部分１５の外面部１ｃに設けられる。除去部Ｑの形状は、特に限定されない。 As shown in FIGS. 7 (a) and 7 (b), the removal unit Q is a second example of the removal unit 16. The removing portion Q is provided on the outer surface portion 1c of the tip end side portion 15 of the pipe portion 1. The shape of the removing portion Q is not particularly limited.
　除去部Ｑは、除去部Ｐ（図５（ａ）参照）と異なり、内側には孔部１７が設けられていない。除去部Ｑは、除去部Ｐのように既設の孔部１７を拡大させるものではなく、先端側部分１５に新たに連通孔部ＱＡ（図８（ａ）及び図８（ｂ）参照）を形成する。 Unlike the removing portion P (see FIG. 5A), the removing portion Q is not provided with the hole portion 17 inside. The removing portion Q does not enlarge the existing hole portion 17 unlike the removing portion P, but newly forms a communication hole portion QA (see FIGS. 8A and 8B) in the tip side portion 15. do.
　管部１の先端側部分１５は、除去部Ｑと蓋部１４とによって閉塞されている。これにより、インプラント１０が眼に装着された状態において（図４参照）、管部１内の流路１１には、除去部Ｑが除去されるまでは、前房２０２内の房水が流入しない。 The tip end side portion 15 of the pipe portion 1 is closed by the removal portion Q and the lid portion 14. As a result, in the state where the implant 10 is attached to the eye (see FIG. 4), the aqueous humor in the anterior chamber 202 does not flow into the flow path 11 in the tube portion 1 until the removal portion Q is removed. ..
　図８（ａ）は、除去部Ｑの除去後の先端側部分１５を示す平面図である。図８（ｂ）は、除去部Ｑの除去後の先端側部分１５を示す断面図である。 FIG. 8A is a plan view showing the tip end side portion 15 after the removal portion Q is removed. FIG. 8B is a cross-sectional view showing the tip end side portion 15 after the removal portion Q is removed.
　図４、及び図７（ａ）～図８（ｂ）に示すように、インプラント１０が眼に装着された状態で、除去部Ｑは、レーザー光Ｌを照射されることによって、管部１の外部と管部１の流路１１とを連通するように除去される。これにより、管部１のうち除去部Ｑが存在していた場所には、管部１の外部と管部１の流路１１とを連通する連通孔部ＱＡが形成される。管部１に連通孔部ＱＡが形成されると、前房２０２内の房水が連通孔部ＱＡを通じて管部１内の流路１１に流入する。これにより、眼圧が低下する。 As shown in FIGS. 4 and 7 (a) to 8 (b), the removal portion Q is irradiated with the laser beam L in the state where the implant 10 is attached to the eye, so that the tube portion 1 is exposed to the laser beam L. It is removed so as to communicate the outside with the flow path 11 of the pipe portion 1. As a result, a communication hole portion QA that communicates the outside of the pipe portion 1 with the flow path 11 of the pipe portion 1 is formed in the place where the removal portion Q is present in the pipe portion 1. When the communication hole QA is formed in the pipe portion 1, the aqueous humor in the anterior chamber 202 flows into the flow path 11 in the pipe portion 1 through the communication hole QA. This reduces intraocular pressure.
　術者は、除去部Ｑを除去することによって、眼圧を調整することができる。 The surgeon can adjust the intraocular pressure by removing the removal portion Q.
　―第２例の変形例―
　第２例では、除去部Ｑが除去されていない状態では、流路１１には房水が流入しない（図７（ａ）参照）。しかし、本発明はこれに限定されない。第２例において、除去部Ｑが除去されていない状態でも、流路１１には房水が流入するように構成してもよい。 -Modification example of the second example-
In the second example, the aqueous humor does not flow into the flow path 11 when the removal portion Q is not removed (see FIG. 7A). However, the present invention is not limited to this. In the second example, the aqueous humor may be configured to flow into the flow path 11 even when the removal portion Q is not removed.
　例えば、管部１の先端側部分１５のうちの除去部Ｑ以外の部分に、管部１の外部と管部１の流路１１とを連通する孔を設け、除去部Ｑが除去されていない状態でも、当該孔を通じて、前房２０２内の房水が流路１１に流入するように構成する。この場合、除去部Ｑが除去されて連通孔部ＱＡ（図８（ｂ）参照）が形成されると、既設の当該孔と連通孔部ＱＡとを通じて、前房２０２から管部１の流路１１に房水が流入するので、流路１１内の房水の流量が増大する。 For example, in the portion of the tip end side portion 15 of the pipe portion 1 other than the removal portion Q, a hole for communicating the outside of the pipe portion 1 and the flow path 11 of the pipe portion 1 is provided, and the removal portion Q is not removed. Even in this state, the aqueous humor in the anterior chamber 202 is configured to flow into the flow path 11 through the hole. In this case, when the removing portion Q is removed and the communication hole portion QA (see FIG. 8B) is formed, the flow path from the anterior chamber 202 to the pipe portion 1 is formed through the existing hole and the communication hole portion QA. Since the aqueous humor flows into 11, the flow rate of the aqueous humor in the flow path 11 increases.
　―管部１の先端側部分１５の構造の第３例―
　図９（ａ）及び図９（ｂ）を参照して、管部１の先端側部分１５の構造の第３例について説明する。図９（ａ）は、先端側部分１５の第３例の平面図である。図９（ｂ）は、図９（ａ）に示す先端側部分１５の第３例の側面断面図である。 -Third example of the structure of the tip end side portion 15 of the pipe portion 1-
A third example of the structure of the distal end side portion 15 of the pipe portion 1 will be described with reference to FIGS. 9 (a) and 9 (b). FIG. 9A is a plan view of the third example of the tip end side portion 15. 9 (b) is a side sectional view of a third example of the tip side portion 15 shown in FIG. 9 (a).
　図９（ａ）及び図９（ｂ）に示すように、管部１の先端側部分１５には、複数の孔部１７が設けられる。複数の孔部１７の各々の周囲には、除去部Ｐが配置される。 As shown in FIGS. 9 (a) and 9 (b), a plurality of holes 17 are provided in the tip end side portion 15 of the pipe portion 1. A removing portion P is arranged around each of the plurality of holes 17.
　―眼圧を調整する処理―
　次に、図４、及び図９（ａ）～図１０を参照して、インプラント１０が装着された眼２００の眼圧を調整する処理（ステップＳ１～ステップＳ５）について説明する。ステップＳ１～ステップＳ５に示す眼圧を調整する処理は、例えば、眼２００にインプラント１０を装着する緑内障手術が行われた後に、症状が悪化し、眼圧が所定の上限値よりも高くなった場合に行われる。 -Process to adjust intraocular pressure-
Next, the process of adjusting the intraocular pressure of the eye 200 to which the implant 10 is attached (steps S1 to S5) will be described with reference to FIGS. 4 and 9 (a) to 10 (10). In the process of adjusting the intraocular pressure shown in steps S1 to S5, for example, after the glaucoma operation in which the implant 10 is attached to the eye 200 is performed, the symptom worsens and the intraocular pressure becomes higher than the predetermined upper limit value. If done.
　本実施形態では、図９（ａ）及び図９（ｂ）に示す管部１の先端側部分１５の構造の第３例を用いて、ステップＳ１～ステップＳ５に示す眼圧を調整する処理が行われる。 In the present embodiment, the process of adjusting the intraocular pressure shown in steps S1 to S5 is performed by using the third example of the structure of the distal end side portion 15 of the tube portion 1 shown in FIGS. 9 (a) and 9 (b). Will be done.
　図１０は、インプラント１０が装着された眼２００の眼圧を調整する手順（ステップＳ１～ステップＳ５）を示すフローチャートである。なお、ステップＳ１～ステップＳ５に示す処理は、インプラントシステム１００を用いて行われる。インプラントシステム１００は、インプラント１０と、照射部４０と、眼圧を計測する計測部５０（図４参照）とを備える。 FIG. 10 is a flowchart showing a procedure (step S1 to step S5) for adjusting the intraocular pressure of the eye 200 to which the implant 10 is attached. The processes shown in steps S1 to S5 are performed using the implant system 100. The implant system 100 includes an implant 10, an irradiation unit 40, and a measurement unit 50 (see FIG. 4) for measuring intraocular pressure.
　図４、図９（ａ）、図９（ｂ）、及び図１０に示すように、ステップＳ１において、インプラント１０が装着された眼２００の眼圧を計測する。詳細には、術者は、計測部５０を用いて、インプラント１０が装着された眼２００の眼圧を計測する。計測部５０、例えば、眼圧計である。眼圧計は、例えば、ゴールドマン眼圧計である。 As shown in FIGS. 4, 9 (a), 9 (b), and 10, in step S1, the intraocular pressure of the eye 200 to which the implant 10 is attached is measured. Specifically, the operator uses the measuring unit 50 to measure the intraocular pressure of the eye 200 to which the implant 10 is attached. The measuring unit 50, for example, a tonometer. The tonometer is, for example, a Goldman tonometer.
　ステップＳ２において、計測した眼圧が所定の上限値より高いか否かを判定する。所定の上限値は、眼圧が正常とされる範囲の上限を示す。所定の上限値は、例えば、一般に正常な眼圧の上限とされる２１ｍｍＨｇである。なお、所定の上限値は、２１ｍｍＨｇより小さくてもよい。例えば、所定の上限値を、１５ｍｍＨｇとしてもよい。理由は、眼圧の計測時以降、眼圧が徐々に上昇する可能性を考慮して、眼圧が２１ｍｍＨｇに到達するよりも前に眼圧の調整を行い、正常な眼圧をより確実に確保するためである。眼圧が所定の上限値より高いとき（ステップＳ２で、Ｙｅｓ）、処理がステップＳ３に移行する。これに対し、眼圧が所定の上限値以下のとき（ステップＳ２で、Ｎｏ）、処理が終了する。 In step S2, it is determined whether or not the measured intraocular pressure is higher than the predetermined upper limit value. The predetermined upper limit indicates the upper limit of the range in which the intraocular pressure is normal. The predetermined upper limit is, for example, 21 mmHg, which is generally the upper limit of normal intraocular pressure. The predetermined upper limit value may be smaller than 21 mmHg. For example, a predetermined upper limit value may be set to 15 mmHg. The reason is that the intraocular pressure is adjusted before the intraocular pressure reaches 21 mmHg in consideration of the possibility that the intraocular pressure gradually increases after the measurement of the intraocular pressure, so that the normal intraocular pressure is more surely obtained. This is to secure it. When the intraocular pressure is higher than the predetermined upper limit value (Yes in step S2), the process proceeds to step S3. On the other hand, when the intraocular pressure is equal to or less than a predetermined upper limit value (No in step S2), the process ends.
　ステップＳ３において、照射部４０からレーザー光Ｌが照射されて、複数の除去部Ｐのうちから１つの除去部Ｐ（図９（ａ）参照）が除去される。 In step S3, the laser beam L is irradiated from the irradiation unit 40, and one removal unit P (see FIG. 9A) is removed from the plurality of removal units P.
　ステップＳ４において、インプラント１０が装着された眼２００の眼圧を計測する。 In step S4, the intraocular pressure of the eye 200 to which the implant 10 is attached is measured.
　ステップＳ５において、計測した眼圧が所定の目標値より高いか否かを判定する。眼圧が所定の目標値より高いとき（ステップＳ５で、Ｙｅｓ）、処理がステップＳ３に移行する。この場合、ステップＳ３において、さらにもう一つの除去部Ｐが除去される。除去される除去部Ｐの個数が多くなる程、前房２０２内から管部１への房水の流入量が増大して、眼圧の低下の程度が大きくなる。そして、ステップＳ５において、眼圧が所定の目標値以下と判定されるまで、ステップＳ３～ステップＳ５に示す処理が繰り返される。これに対し、眼圧が所定の目標値以下のとき（ステップＳ５で、Ｎｏ）、処理が終了する。所定の目標値は、例えば、１０ｍｍＨｇである。なお、所定の目標値は、２１ｍｍＨｇ以下であればよい。しかし、眼圧の調整が終了した後、眼圧が徐々に上昇する可能性を考慮すると、所定の目標値を、本実施形態のように、１０ｍｍＨｇ程度に設定することが好ましい。 In step S5, it is determined whether or not the measured intraocular pressure is higher than the predetermined target value. When the intraocular pressure is higher than the predetermined target value (Yes in step S5), the process proceeds to step S3. In this case, in step S3, yet another removing unit P is removed. As the number of removed portions P to be removed increases, the amount of aqueous humor flowing from the anterior chamber 202 into the tube portion 1 increases, and the degree of decrease in intraocular pressure increases. Then, in step S5, the processes shown in steps S3 to S5 are repeated until the intraocular pressure is determined to be equal to or less than a predetermined target value. On the other hand, when the intraocular pressure is equal to or less than a predetermined target value (No in step S5), the process ends. The predetermined target value is, for example, 10 mmHg. The predetermined target value may be 21 mmHg or less. However, considering the possibility that the intraocular pressure gradually increases after the adjustment of the intraocular pressure is completed, it is preferable to set a predetermined target value to about 10 mmHg as in the present embodiment.
　以上のように、眼圧が所定の目標値以下と判定されるまで、ステップＳ３～ステップＳ５に示す処理が繰り返される。従って、眼圧が所定の目標値以下になるまで、除去部Ｐを１つずつ除去していくことで、管部１（第２開口部１３）が排出する房水の流量を徐々に増加させ、眼圧を徐々に下げることができる。その結果、眼圧の急激な変動を抑制し、眼圧を調整する作業を安定した状態で行うことができる。 As described above, the processes shown in steps S3 to S5 are repeated until the intraocular pressure is determined to be equal to or lower than the predetermined target value. Therefore, by removing the removal portions P one by one until the intraocular pressure becomes equal to or lower than the predetermined target value, the flow rate of the aqueous humor discharged by the tube portion 1 (second opening 13) is gradually increased. , The intraocular pressure can be gradually reduced. As a result, it is possible to suppress abrupt fluctuations in the intraocular pressure and perform the work of adjusting the intraocular pressure in a stable state.
　―眼圧を調整する処理の変形例―
　なお、本実施形態では、管部１の先端側部分１５に複数の除去部Ｐを設け（図９（ａ）及び図９（ｂ）参照）、当該複数の除去部Ｐを含む管部１を用いて、ステップＳ１～ステップＳ５に示す処理（図１０参照）が行われる。しかし、本発明はこれに限定されない。管部１の先端側部分１５に複数の除去部Ｑ（図７（ａ）参照）を設け、当該複数の除去部Ｑを含む管部１を用いて、ステップＳ１～ステップＳ５に示す処理が行われてもよい。この場合、ステップＳ３に示す処理が行われる毎に、複数の除去部Ｑが一つずつ除去される。 -A modified example of the process of adjusting intraocular pressure-
In this embodiment, a plurality of removing portions P are provided on the tip end side portion 15 of the pipe portion 1 (see FIGS. 9A and 9B), and the pipe portion 1 including the plurality of removing portions P is provided. Using the above, the processes shown in steps S1 to S5 (see FIG. 10) are performed. However, the present invention is not limited to this. A plurality of removing portions Q (see FIG. 7A) are provided on the tip end side portion 15 of the pipe portion 1, and the processing shown in steps S1 to S5 is performed using the pipe portion 1 including the plurality of removing portions Q. You may be broken. In this case, each time the process shown in step S3 is performed, the plurality of removal units Q are removed one by one.
　以上、図面（図１～図１０）を参照しながら本発明の実施形態について説明した。但し、本発明は、上記の実施形態に限られるものではなく、その要旨を逸脱しない範囲で種々の態様において実施することが可能である（例えば、（１）～（１０））。また、上記の実施形態に開示されている複数の構成要素を適宜組み合わせることによって、種々の発明の形成が可能である。例えば、実施形態に示される全構成要素から幾つかの構成要素を削除してもよい。図面は、理解しやすくするために、それぞれの構成要素を主体に模式的に示しており、図示された各構成要素の個数等は、図面作成の都合から実際とは異なる場合もある。また、上記の実施形態で示す各構成要素は一例であって、特に限定されるものではなく、本発明の効果から実質的に逸脱しない範囲で種々の変更が可能である。

　（１）インプラント１０は、人間の眼のみならず、例えば、犬のような人間以外の動物の眼にも装着可能である。また、インプラント１０が装着された眼の眼圧を調整する方法（ステップＳ１～ステップＳ５参照）は、人間に対してのみならず、人間以外の動物に対しても適用することが可能である。 The embodiments of the present invention have been described above with reference to the drawings (FIGS. 1 to 10). However, the present invention is not limited to the above embodiment, and can be implemented in various embodiments without departing from the gist of the present invention (for example, (1) to (10)). In addition, various inventions can be formed by appropriately combining the plurality of components disclosed in the above embodiments. For example, some components may be removed from all the components shown in the embodiments. In order to make the drawings easier to understand, each component is schematically shown, and the number of each component shown may differ from the actual one due to the convenience of drawing. Further, each component shown in the above embodiment is an example, and is not particularly limited, and various changes can be made without substantially deviating from the effect of the present invention.

(1) The implant 10 can be attached not only to the human eye but also to the eye of a non-human animal such as a dog. Further, the method of adjusting the intraocular pressure of the eye to which the implant 10 is attached (see steps S1 to S5) can be applied not only to humans but also to animals other than humans.
　（２）除去部１６の寸法、及び／又は、流路１１の断面積の大きさが互いに異なる複数のインプラント１０を用意し、患者の緑内障の症状の重さ（眼圧の高さ）に応じて、複数のインプラント１０のうちから患者の眼に装着するインプラント１０を選択してもよい。例えば、患者の症状が重くなる程、除去部１６の寸法が大きく、及び／又は、流路１１の断面積が大きいインプラント１０を用いる。その結果、患者の症状の重さに応じて効果的に眼圧を調整することが可能になる。流路１１の断面積は、流路１１の延びる方向に対して垂直な断面の面積を示す。 (2) Prepare a plurality of implants 10 having different dimensions of the removal portion 16 and / or the size of the cross-sectional area of the flow path 11, depending on the severity of the glaucoma symptom (high intraocular pressure) of the patient. Therefore, the implant 10 to be attached to the patient's eye may be selected from the plurality of implants 10. For example, the implant 10 has a larger size of the removed portion 16 and / or a larger cross-sectional area of the flow path 11 as the patient's symptom becomes heavier. As a result, it becomes possible to effectively adjust the intraocular pressure according to the severity of the patient's symptoms. The cross-sectional area of the flow path 11 indicates the area of the cross section perpendicular to the extending direction of the flow path 11.
　（３）本実施形態のインプラント１０は、管部１と、板部３とを備える。しかし、本発明はこれに限定されない。図１１に示すように、インプラント１０は、板部３を備えていなくてもよく、少なくとも、除去部１６を含む管部１を備えていればよい。つまり、インプラント１０は、管部１の内部に流路１１を形成し、眼２００で生成された房水を、流路１１を通じて眼２００の外部に案内する機能を有していればよい。インプラント１０が板部３を備えず、除去部１６を含む管部１を備える場合、インプラント１０が眼２００に装着されると、例えば、インプラント１０が以下の（ｉ）～（ｉｉｉ）に示す状態になる。（ｉ）管部１の第１端部１ａが前房２０２内に挿入されている。（ｉｉ）管部１の中途部が強膜２０１と結膜２０６との間に配置されている。（ｉｉｉ）管部１の第２端部１ｂが強膜２０１の後部に直接又は間接に固定されている。強膜２０１の後部は、強膜２０１のうち、結膜２０６よりも眼２００の後方に位置する部分を示す。その結果、板部３を用いず、インプラント１０をシンプルに構成することが可能になる。 (3) The implant 10 of the present embodiment includes a tube portion 1 and a plate portion 3. However, the present invention is not limited to this. As shown in FIG. 11, the implant 10 does not have to include the plate portion 3, and may at least include the tube portion 1 including the removal portion 16. That is, the implant 10 may have a function of forming a flow path 11 inside the tube portion 1 and guiding the aqueous humor generated by the eye 200 to the outside of the eye 200 through the flow path 11. When the implant 10 does not have the plate portion 3 and has the tubular portion 1 including the removal portion 16, when the implant 10 is attached to the eye 200, for example, the implant 10 is in the state shown in the following (i) to (iii). become. (I) The first end 1a of the tube 1 is inserted into the anterior chamber 202. (Ii) The middle part of the tube portion 1 is arranged between the sclera 201 and the conjunctiva 206. (Iii) The second end portion 1b of the tube portion 1 is directly or indirectly fixed to the rear portion of the sclera 201. The posterior part of the sclera 201 indicates the portion of the sclera 201 located behind the eye 200 with respect to the conjunctiva 206. As a result, the implant 10 can be simply configured without using the plate portion 3.
　（４）インプラント１０が眼２００に装着された状態で、本実施形態の管部１は、前房２０２から眼２００の後側に延びるように配置される。しかし、管部１の配置場所は特に限定されない。インプラント１０が眼２００に装着された状態で、流路１１を通じて眼２００の外部に房水を案内できる場所に、管部１が配置されればよい。 (4) With the implant 10 attached to the eye 200, the tube portion 1 of the present embodiment is arranged so as to extend from the anterior chamber 202 to the posterior side of the eye 200. However, the place where the pipe portion 1 is arranged is not particularly limited. With the implant 10 attached to the eye 200, the tube portion 1 may be arranged at a place where the aqueous humor can be guided to the outside of the eye 200 through the flow path 11.
　（５）本実施形態では、ステップＳ３に示す処理（図１０参照）が行われる毎に、１つの除去部１６が除去されるが、本発明はこれに限定されない。例えば、ステップＳ１において計測した眼圧が、所定の上限値に対して過度に高い場合、ステップＳ３において２つ以上の除去部１６が除去されてもよい。つまり、ステップＳ１において計測した眼圧の高さに応じて、ステップＳ３において除去する除去部１６の個数が変更される。本実施形態では、除去する除去部１６の個数は、術者が決定する。なお、ステップＳ３において除去する除去部１６の個数は、例えば、術者の経験則に基づいて決定されてもよい。 (5) In the present embodiment, one removal unit 16 is removed each time the process shown in step S3 (see FIG. 10) is performed, but the present invention is not limited to this. For example, if the intraocular pressure measured in step S1 is excessively high with respect to a predetermined upper limit value, two or more removing units 16 may be removed in step S3. That is, the number of removing portions 16 to be removed in step S3 is changed according to the height of the intraocular pressure measured in step S1. In the present embodiment, the number of removing portions 16 to be removed is determined by the operator. The number of removing portions 16 to be removed in step S3 may be determined, for example, based on the operator's empirical rule.
　以上、ステップＳ１において計測した眼圧の大きさに応じて、ステップＳ３において、第１除去部Ｐ１～第Ｎ除去部ＰＮのうちから、除去する除去部１６の個数が決定される。その結果、眼圧を所定の目標値よりも低下させる作業を効率的に行うことが可能になる。 As described above, in step S3, the number of removal units 16 to be removed is determined from the first removal unit P1 to the Nth removal unit PN according to the magnitude of the intraocular pressure measured in step S1. As a result, it becomes possible to efficiently perform the work of lowering the intraocular pressure below a predetermined target value.
　―管部１の先端側部分１５の構造の第４例―
　（６）図１２（ａ）～図１２（ｃ）を参照して、管部１の先端側部分１５の構造の第４例について説明する。図１２（ａ）は、管部１の先端側部分１５の構造の第４例の平面図である。図１２（ｂ）は、図１２（ａ）に示す先端側部分１５の第４例の側面断面図である。図１２（ｃ）は、複数の除去部Ｐの除去後の管部１の先端側部分１５の平面図である。 -Fourth example of the structure of the tip end side portion 15 of the pipe portion 1-
(6) A fourth example of the structure of the tip end side portion 15 of the pipe portion 1 will be described with reference to FIGS. 12 (a) to 12 (c). FIG. 12A is a plan view of a fourth example of the structure of the distal end side portion 15 of the pipe portion 1. 12 (b) is a side sectional view of a fourth example of the tip end side portion 15 shown in FIG. 12 (a). FIG. 12 (c) is a plan view of the tip end side portion 15 of the pipe portion 1 after the removal of the plurality of removal portions P.
　図１２（ａ）及び図１２（ｂ）に示すように、第４例では、管部１の先端側部分１５には、複数の孔部１７と、複数の除去部Ｐとが設けられる。複数の孔部１７は、第１孔部１７１～第Ｎ孔部１７Ｎを含む。Ｎは、２以上の整数である。複数の除去部Ｐは、第１除去部Ｐ１～第Ｎ除去部ＰＮを含む。第１孔部１７１～第Ｎ孔部１７Ｎの周囲には、それぞれ、第１除去部Ｐ１～第Ｎ除去部ＰＮが配置される。 As shown in FIGS. 12 (a) and 12 (b), in the fourth example, a plurality of holes 17 and a plurality of removal portions P are provided in the tip end side portion 15 of the pipe portion 1. The plurality of hole portions 17 include the first hole portion 171 to the Nth hole portion 17N. N is an integer of 2 or more. The plurality of removal units P include a first removal unit P1 to an Nth removal unit PN. Around the first hole portion 171 to the Nth hole portion 17N, the first removal portion P1 to the Nth removal portion PN are arranged, respectively.
　図１２（ｃ）に示すように、レーザー光Ｌにより第１除去部Ｐ１～第Ｎ除去部ＰＮが、それぞれ除去されると、第１拡大孔部ＰＡ１～第Ｎ拡大孔部ＰＡＮがそれぞれ形成される。第１拡大孔部ＰＡ１～第Ｎ拡大孔部ＰＡＮの寸法が、互いに異なる。本実施形態では、第１拡大孔部ＰＡ１～第Ｎ拡大孔部ＰＡＮの寸法は、第１拡大孔部ＰＡ１～第Ｎ拡大孔部ＰＡＮの順番に大きくなる。拡大孔部ＰＡの寸法が大きくなる程、前房２０２から管部１へ流入する単位時間当たりの房水の量が多くなる。 As shown in FIG. 12 (c), when the first removing portion P1 to the Nth removing portion PN are removed by the laser beam L, the first enlarged hole portion PA1 to the Nth enlarged hole portion PAN are formed, respectively. Laser. The dimensions of the first enlarged hole PA1 to the Nth enlarged hole PAN are different from each other. In the present embodiment, the dimensions of the first expanded hole portion PA1 to the Nth expanded hole portion PAN increase in the order of the first expanded hole portion PA1 to the Nth expanded hole portion PAN. As the size of the enlarged hole PA increases, the amount of aqueous humor flowing from the anterior chamber 202 into the pipe 1 per unit time increases.
　（７）図１２（ａ）～図１３を参照して、変化情報８０について説明する。図１３は、変化情報８０を示す図である。 (7) The change information 80 will be described with reference to FIGS. 12 (a) to 13. FIG. 13 is a diagram showing change information 80.
　変化情報８０では、図１２（ａ）及び図１２（ｂ）に示す管部１の先端側部分１５の構造の第４例が採用される。 In the change information 80, the fourth example of the structure of the tip end side portion 15 of the pipe portion 1 shown in FIGS. 12 (a) and 12 (b) is adopted.
　図１２（ａ）～図１３に示すように、変化情報８０は、（Ａ）第１除去部Ｐ１～第Ｎ除去部ＰＮのうち除去される除去部Ｐと、（Ｂ）当該除去部Ｐの除去後の眼圧とを対応付けた情報である。除去後の眼圧は、例えば、除去後の眼圧の値、除去後の眼圧の変化量、又は、除去後の眼圧の変化の割合のうちのいずれかを示す。本実施形態では、除去後の眼圧は、眼圧の変化の割合を示す。変化情報８０は、予め実験を行うことで取得される。なお、変化情報８０で示される、（Ｂ）の値は、一定の値でもよく、又は、Ｄ以上Ｅ以下のような上限と下限を有する幅を持った値でもよい。Ｄ、及びＥは実数である。 As shown in FIGS. 12A to 13, the change information 80 includes the removal unit P to be removed from the first removal unit P1 to the Nth removal unit PN, and (B) the removal unit P. This is information associated with the intraocular pressure after removal. The intraocular pressure after removal indicates, for example, one of the value of the intraocular pressure after removal, the amount of change in intraocular pressure after removal, or the rate of change in intraocular pressure after removal. In this embodiment, the intraocular pressure after removal indicates the rate of change in intraocular pressure. The change information 80 is acquired by conducting an experiment in advance. The value of (B) shown in the change information 80 may be a constant value, or may be a value having a width having an upper limit and a lower limit such as D or more and E or less. D and E are real numbers.
　変化情報８０は、インプラントシステム１００（図４参照）の構成要素である。変化情報８０は、例えば、ＵＳＢメモリー及びハードディスクのような記憶部に記憶される。 The change information 80 is a component of the implant system 100 (see FIG. 4). The change information 80 is stored in a storage unit such as a USB memory and a hard disk.
　―変化情報８０の使用例―
　変化情報８０は、例えば、ステップＳ３（図１０参照）において除去する除去部Ｐの個数を決定する際に用いられる。以下では、変化情報８０を用いて、除去する除去部Ｐの個数を決定する手順の一例について説明する。 -Example of using change information 80-
The change information 80 is used, for example, when determining the number of removal units P to be removed in step S3 (see FIG. 10). Hereinafter, an example of a procedure for determining the number of removal units P to be removed using the change information 80 will be described.
　術者は、ステップＳ１（図１０参照）で計測された眼圧を確認すると、変化情報８０（図１３参照）を確認する。そして、術者は、第１除去部Ｐ１～第Ｎ除去部ＰＮのうち、除去することで所定の目標値以下まで眼圧を低下させることができる１つ又は２つ以上の除去部Ｐを、変化情報８０に基づいて選択する。そして、術者は、第１除去部Ｐ１～第Ｎ除去部ＰＮのうち、選択した除去部Ｐに対して、照射部４０からレーザー光Ｌを照射する。これにより、術者の選択した除去部１６が除去される。その結果、術者は、眼圧が所定の目標値以下になるように、眼圧を容易に調整できる。 When the operator confirms the intraocular pressure measured in step S1 (see FIG. 10), the operator confirms the change information 80 (see FIG. 13). Then, the surgeon removes one or two or more removal parts P from the first removal part P1 to the Nth removal part PN, which can reduce the intraocular pressure to a predetermined target value or less by removing the first removal part P1 to the Nth removal part PN. Select based on change information 80. Then, the operator irradiates the selected removal unit P from the first removal unit P1 to the Nth removal unit PN with the laser light L from the irradiation unit 40. As a result, the removing portion 16 selected by the operator is removed. As a result, the surgeon can easily adjust the intraocular pressure so that the intraocular pressure is equal to or less than a predetermined target value.
　―変化情報８０の変形例―
　変化情報８０の変形例について説明する。まず、変化情報８０の変形例で採用される管部１の構成について説明する。 -Modification example of change information 80-
A modification of the change information 80 will be described. First, the configuration of the pipe portion 1 adopted in the modified example of the change information 80 will be described.
　管部１の先端側部分１５には、複数の除去部Ｑ（図７（ａ）参照）が設けられる。複数の除去部Ｑは、第１除去部Ｑ１～第Ｎ除去部ＱＮ（不図示）で構成される。第１除去部Ｑ１～第Ｎ除去部ＱＮの寸法は、互いに異なる。本実施形態では、第１除去部Ｑ１～第Ｎ除去部ＱＮの寸法は、第１除去部Ｑ１～第Ｎ除去部ＱＮの順番に大きくなる。 A plurality of removal portions Q (see FIG. 7A) are provided on the tip end side portion 15 of the pipe portion 1. The plurality of removal units Q are composed of a first removal unit Q1 to an Nth removal unit QN (not shown). The dimensions of the first removing portion Q1 to the Nth removing portion QN are different from each other. In the present embodiment, the dimensions of the first removal unit Q1 to the Nth removal unit QN increase in the order of the first removal unit Q1 to the Nth removal unit QN.
　変化情報８０の変形例では、（Ａ）第１除去部Ｑ１～第Ｎ除去部ＱＮのうち除去される除去部Ｑと、（Ｂ）当該除去部Ｑの除去後の眼圧とが対応付けられる。 In the modified example of the change information 80, (A) the removed part Q to be removed from the first removed part Q1 to the Nth removed part QN and (B) the intraocular pressure after the removal of the removed part Q are associated with each other. ..
　―変化情報８０の変形例の使用例―
　変化情報８０の変形例の使用例について説明する。 -Example of using the modified example of change information 80-
An example of using a modified example of the change information 80 will be described.
　術者は、ステップＳ１～ステップＳ５（図１０参照）に示す処理を行う。この際、ステップＳ３において、術者は、第１除去部Ｑ１～第Ｎ除去部ＱＮのうち、除去することで所定の目標値以下まで眼圧を低下させることができる１つ又は２つ以上の除去部Ｑを変化情報８０に基づいて選択する。その結果、術者は、眼圧が所定の目標値以下になるように、眼圧を容易に調整できる。 The surgeon performs the processes shown in steps S1 to S5 (see FIG. 10). At this time, in step S3, the operator can reduce the intraocular pressure to a predetermined target value or less by removing one or more of the first removal unit Q1 to the Nth removal unit QN. The removal unit Q is selected based on the change information 80. As a result, the surgeon can easily adjust the intraocular pressure so that the intraocular pressure is equal to or less than a predetermined target value.
　―管部１の先端側部分１５の構造の第５例―
　（８）図１４（ａ）及び図１４（ｂ）を参照して、管部１の先端側部分１５の構造の第５例について説明する。図１４（ａ）は、管部１の先端側部分１５の構造の第５例の平面図である。図１４（ｂ）は、図１４（ａ）に示す先端側部分１５の第５例の側面断面図である。 -Fifth example of the structure of the tip end side portion 15 of the pipe portion 1-
(8) A fifth example of the structure of the distal end side portion 15 of the pipe portion 1 will be described with reference to FIGS. 14 (a) and 14 (b). FIG. 14A is a plan view of a fifth example of the structure of the distal end side portion 15 of the pipe portion 1. 14 (b) is a side sectional view of a fifth example of the tip side portion 15 shown in FIG. 14 (a).
　図１４（ａ）及び図１４（ｂ）に示すように、先端側部分１５には、孔部１７の周囲に配置される除去部Ｐと、除去部Ｑとの両方が設けられる。 As shown in FIGS. 14 (a) and 14 (b), the tip side portion 15 is provided with both a removal portion P and a removal portion Q arranged around the hole portion 17.
　―管部１の開放構造―
　（９）図１５（ａ）及び図１５（ｂ）を参照して、管部１の開放構造について説明する。図１５（ａ）は、管部１の側面断面図である。図１５（ｂ）は、管部１の側面断面である。 -Open structure of pipe 1-
(9) The open structure of the pipe portion 1 will be described with reference to FIGS. 15 (a) and 15 (b). FIG. 15A is a side sectional view of the pipe portion 1. FIG. 15B is a side cross section of the pipe portion 1.
　図１５（ａ）及び図１５（ｂ）に示すように、管部１の開放構造では、管部１の第１開口部１２には、蓋部１４が設けられていない。第１開口部１２は開放されることで、管部１の外部と管部１内の流路１１とを連通している。 As shown in FIGS. 15A and 15B, in the open structure of the pipe portion 1, the lid portion 14 is not provided in the first opening portion 12 of the pipe portion 1. By opening the first opening 12, the outside of the pipe 1 and the flow path 11 inside the pipe 1 are communicated with each other.
　図４、及び図１５（ａ）に示すように、インプラント１０が眼に装着された状態で、流路１１には、第１開口部１２及び孔部１７の両方から前房２０２内の房水が流入する。 As shown in FIGS. 4 and 15 (a), with the implant 10 attached to the eye, the flow path 11 has aqueous humor in the anterior chamber 202 from both the first opening 12 and the hole 17. Inflows.
　図４、及び図１５（ｂ）に示すように、インプラント１０が眼に装着された状態で、レーザー光Ｌにより除去部Ｐが除去されると、孔部１７が拡大孔部ＰＡとなることで、流路１１へ流入する房水の量が除去部Ｐの除去前よりも増大する。その結果、術者は、除去部Ｐを除去するか否かを選択することで、眼圧を調整することができる。 As shown in FIGS. 4 and 15B, when the removal portion P is removed by the laser beam L while the implant 10 is attached to the eye, the hole portion 17 becomes the enlarged hole portion PA. , The amount of aqueous humor flowing into the flow path 11 is larger than that before the removal of the removal portion P. As a result, the operator can adjust the intraocular pressure by selecting whether or not to remove the removed portion P.
　なお、図１５（ａ）及び図１５（ｂ）に示す管部１の開放構造（第１開口部１２を開放する構成）は、図５（ａ）に示す管部１の先端側部分１５の構造の第１例で採用されている。しかし、本発明は、これに限定されない。管部１の開放構造は、本実施形態で示された第１例以外の全ての構成（図７（ａ）～図９（ｂ）、図１２（ａ）～図１２（ｃ）、図１４（ａ）、図１４（ｂ）等）で採用することができる。 The open structure of the pipe portion 1 shown in FIGS. 15 (a) and 15 (b) (the configuration in which the first opening portion 12 is opened) is the tip side portion 15 of the pipe portion 1 shown in FIG. 5 (a). It is adopted in the first example of the structure. However, the present invention is not limited to this. The open structure of the pipe portion 1 has all the configurations (FIGS. 7 (a) to 9 (b), FIGS. 12 (a) to 12 (c), and FIG. 14) other than the first example shown in the present embodiment. (A), FIG. 14 (b), etc.) can be adopted.
　本発明は、眼の治療に用いられるインプラント及びインプラントシステムの分野に利用可能である。 The present invention is available in the field of implants and implant systems used in the treatment of the eye.

Claims (9)

  1. 　眼に装着可能なインプラントであって、
    　内部に房水の流路が形成される管部を備え、
    　前記管部の外面部には、レーザー光を照射されることで前記管部の外部と前記管部の流路とを連通するように除去される除去部が設けれる、インプラント。     An implant that can be worn on the eye
    Equipped with a pipe part where the flow path of aqueous humor is formed inside
    An implant in which an outer surface portion of the tube portion is provided with a removal portion that is removed so as to communicate the outside of the tube portion with the flow path of the tube portion by being irradiated with laser light.
  2. 　前記管部は、前記管部の外部と前記管部の流路とを連通する孔部をさらに含み、
    　前記除去部は、前記孔部の周囲に配置される、請求項１に記載のインプラント。     The pipe portion further includes a hole portion communicating the outside of the pipe portion and the flow path of the pipe portion.
    The implant according to claim 1, wherein the removal portion is arranged around the hole portion.
  3. 　前記管部は、前記インプラントが前記眼に装着された状態で、前記眼の前房に配置される先端側部分を含み、
    　前記除去部は、前記先端側部分に配置される、請求項１又は請求項２に記載のインプラント。     The tubule comprises an distal portion located in the anterior chamber of the eye with the implant attached to the eye.
    The implant according to claim 1 or 2, wherein the removal portion is arranged on the distal end side portion.
  4. 　前記インプラントが前記眼に装着された状態で、前記除去部は前記眼の前房に配置される、請求項１から請求項３のいずれか１項に記載のインプラント。 The implant according to any one of claims 1 to 3, wherein the removal portion is arranged in the anterior chamber of the eye while the implant is attached to the eye.
  5. 　前記インプラントが前記眼に装着された状態で、前記除去部は前記眼の角膜の奥側に配置される、請求項１から請求項４のいずれか１項に記載のインプラント。 The implant according to any one of claims 1 to 4, wherein the removal portion is arranged on the back side of the cornea of the eye while the implant is attached to the eye.
  6. 　前記除去部は、前記眼の角膜を透過する前記レーザー光を照射されることで除去される、請求項１から請求項５のいずれか１項に記載のインプラント。 The implant according to any one of claims 1 to 5, wherein the removing portion is removed by irradiating the laser beam passing through the cornea of the eye.
  7. 　前記管部には、複数の前記除去部が配置される、請求項１から請求項６のいずれか１項に記載のインプラント。 The implant according to any one of claims 1 to 6, wherein a plurality of the removal portions are arranged in the tube portion.
  8. 　前記複数の除去部は、互いに異なる寸法を有する、請求項７に記載のインプラント。 The implant according to claim 7, wherein the plurality of removal portions have different dimensions from each other.
  9. 　請求項１から請求項８のいずれか１項に記載のインプラントと、
    　前記レーザー光を照射する照射部と、
    　眼圧を計測する計測部と
    　を備える、インプラントシステム。　     The implant according to any one of claims 1 to 8, and the implant.
    The irradiation unit that irradiates the laser beam and
    An implant system equipped with a measuring unit that measures intraocular pressure.
PCT/JP2021/000404 2021-01-07 2021-01-07 Implant and implant system WO2022149249A1 (en)

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US5626558A (en) * 1995-05-05 1997-05-06 Suson; John Adjustable flow rate glaucoma shunt and method of using same
US20020193725A1 (en) * 2000-02-24 2002-12-19 Odrich Steven A. Injectable glaucoma device
US20030236483A1 (en) * 2002-06-25 2003-12-25 Ren David H Dual drainage ocular shunt for glaucoma
JP2010533565A (en) * 2007-07-17 2010-10-28 トランセンド・メディカル・インコーポレイテッド Intraocular implant with hydrogel expansion capability
JP2010540096A (en) * 2007-09-24 2010-12-24 イバンティス インコーポレイテッド Ocular graft and intraocular transplantation method
JP2014513574A (en) * 2011-02-23 2014-06-05 グリースハーバー オフサルミック リサーチ ファンデーション Implants for treating glaucoma
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WO2019193326A1 (en) * 2018-04-03 2019-10-10 Ucl Business Plc Drainage device and methods

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