WO2004060219A1 - 緑内障治療用房水排出インプラント - Google Patents
緑内障治療用房水排出インプラント Download PDFInfo
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- WO2004060219A1 WO2004060219A1 PCT/JP2003/016284 JP0316284W WO2004060219A1 WO 2004060219 A1 WO2004060219 A1 WO 2004060219A1 JP 0316284 W JP0316284 W JP 0316284W WO 2004060219 A1 WO2004060219 A1 WO 2004060219A1
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- Prior art keywords
- aqueous humor
- tube
- filter
- humor drainage
- eyeball
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment
Definitions
- the present invention relates to a therapeutic device that is used for the purpose of lowering intraocular pressure in glaucoma and other diseases in which intraocular pressure is increased, and that effectively discharges aqueous humor from the eye to the outside of the conjunctiva.
- aqueous humor In the normal eye, aqueous humor is produced by the ciliary body, circulates in the anterior and posterior chambers, and is excreted out of the eye through the Schlemm's canal trabecular meshwork, which has a constant resistance to aqueous humor outflow.
- Normal intraocular pressure is set at 21 mmHg or less, but excessive aqueous humor may be injected into the eye if the aqueous humor outflow of the Schlemm's canal trabecular meshwork occurs essentially or secondary to inflammation. It is believed that the glaucoma develops and causes glaucoma due to increased intraocular pressure. Glaucoma is a disease characterized by elevated intraocular pressure and optic neuropathy due to it. The main symptom is visual field loss and visual impairment, and may be blind if appropriate treatment is not given.
- regulating intraocular pressure is the only treatment for glaucoma.
- the goal of treatment is to reduce intraocular pressure and stop the progression of optic atrophy by treatment.
- it is necessary to suppress the production of aqueous humor or to promote the outflow of aqueous humor.
- Treatment methods are classified into conservative treatment and open treatment.
- Conservative treatment is to reduce intraocular pressure using eye drops and oral medications, but if conservative treatment alone does not provide sufficient intraocular pressure reduction For invasive treatment.
- Open treatment is intended to promote the outflow of aqueous humor.
- Trabeculectomy is a typical example of open surgery. This is because the opening to the anterior chamber is artificially created in the sclera so that the aqueous humor is drained from the anterior chamber into the subconjunctival tissue and absorbed by the subconjunctival tissue. This is a method of forming a filter vesicle below.
- this technique requires anterior chamber dysplasia due to excessive drainage of aqueous humor in the early postoperative period, choroidal detachment, ocular maculopathy, malignant glaucoma, and occlusion of the aqueous humor drainage due to wound healing in the late postoperative period.
- the conjunctiva can cause many complications such as high intraocular pressure, aqueous humor leakage from the filtering bleb, and endophthalmitis due to aqueous humor insufficiency due to adhesion between the sclera.
- aqueous humor drainage devices aqueous drainage implants
- the currently used aqueous humor drainage plant drains aqueous humor below the conjunctiva and absorbs aqueous humor through the subconjunctival tissue, similar to trabeculectomy, and connects the intraocular and subconjunctival spaces. It consists of a tube and a plate placed in the subconjunctival space.
- aqueous humor drainage device that aims to prevent the blockage of the aqueous humor drainage channel with a tube, and to prevent adhesion between the conjunctiva and sclera with a plate to secure a space for aqueous humor absorption.
- One of the conventional techniques proposes a method of passing aqueous humor through a nasolacrimal duct through a tube (for example, see Patent Document 1).
- the method of installing the aqueous humor drainage tube is to form a tracheid in the lacrimal sac and insert the tube directly into the nasolacrimal duct, or to insert the tube from the lacrimal canaliculus to the nasolacrimal duct through the eyelid tissue.
- the procedure is complicated, and the surgical invasion increases.
- the filter for preventing retrograde infection has a flat plate shape and is made of a Millipore filter (Millipore). Although it is described that this filter is installed at the end of the tube on the nasolacrimal side, the technique is complicated and the invasiveness of the operation is increased.
- Millipore filter Millipore
- the function of the Mi-lipoic A filter for the dimensions of the filter is preferably in the range of 0.1 to 10 m.However, this filter function prevents retrograde infection by a virus with a diameter of about 0.02 zm, such as parvovirus. It seems impossible to do so.
- Another conventional technique proposes a method in which a tube with one filter is taken out of the eye and out of the conjunctiva, and is placed in the conjunctival sac and placed there (for example, see Patent Document 2).
- the filter for preventing retrograde infection has a rectangular parallelepiped shape and is filled with polycarbonate fibers. And it is said that this filter is installed on the conjunctiva, but with this rectangular parallelepiped shape, there is a very high risk of damaging the conjunctiva and cornea after installation.
- a filter with a level of 0.22111 having a pore size of about 0.22 It is stated that however, it is considered that a filter having a pore size of about 0.22 ⁇ cannot prevent retrograde infection by a virus having a diameter of about 0.22 ⁇ m, such as parvovirus.
- a virus having a diameter of about 0.22 ⁇ m such as parvovirus.
- Another conventional technique proposes a method in which a discharge tube using a hollow fiber membrane is penetrated and implanted in the sclera, placed in the conjunctival sac, and drained from aqueous humor (for example, see Patent Document 3). ).
- a discharge tube using a hollow fiber membrane is penetrated and implanted in the sclera, placed in the conjunctival sac, and drained from aqueous humor.
- the discharge tube of the aqueous humor discharge plant is not composed of a plurality of tubes but is configured as a single body, and has a structure with poor flexibility. For this reason, placing the device for draining aqueous humor in the conjunctival sac may cause conjunctival hemorrhage, allergic reaction, or foreign body sensation during blinking. It is described that a hollow fiber membrane composed of a porous membrane having pores having a pore size of about 0.05 to 0.3 ⁇ is used for a filter to be used. .
- the hollow fiber membrane when the hollow fiber membrane is used as a filter and a long period of time has passed, the hollow fiber membrane is clogged with proteins and the like contained in the aqueous humor and the filter is not used. Transmission performance may be reduced. If the permeability of the filter decreases, there is a risk that the resistance to aqueous humor outflow will increase and the intraocular pressure will rise again.However, this has not been touched on, and there is no mention of how to deal with it. Not been. Further, since the aqueous humor drainage device described in Patent Document 3 is installed so as to penetrate the cornea, removing and replacing the aqueous humor drainage device is a highly invasive operation. It is easily anticipated that complications such as endositis, corneal astigmatism, and corneal insufficiency will be caused at a high rate.
- Patent Document 1 U.S. Pat. No. 4,886,888 specification (19989 1
- Patent Document 2 U.S. Pat. No. 5,344,644 (published on September 13, 1994)
- Patent Literature 3 Japanese Patent Application Laid-Open No. Hei 8 — 117267 (published May 14, 1996)
- the present invention has been made to solve the above-mentioned problems, and has as its object the purpose of the present invention is to minimize the invasiveness of surgery and to reduce the risk of injuries to the eyes and nasolacrimal duct even after installation. It is another object of the present invention to provide an aqueous humor drainage plant for treating glaucoma, which discharges aqueous humor out of the conjunctiva while preventing retrograde infection, and can maintain the effect of lowering intraocular pressure over a long period of time. Disclosure of the invention
- the water guide tube for guiding the aqueous humor to a part of the filter outside the eyeball is composed of the eyeball-side water transfer tube and the extraconjunctival waterway tube, and the eyeball-side waterway tube and the filter unit are connected via the extraconjunctival waterway tube.
- the aqueous humor drainage plant for treating glaucoma of the present invention in order to solve the above-mentioned problems, has a water guiding tube portion for guiding aqueous humor to the outside of the eye, and prevents retrograde infection from outside the eye to the inside of the eye.
- An aqueous humor drainage plant for treating glaucoma for discharging aqueous humor from the eyeball to the outside of the conjunctiva comprising a filter part connected to one end of the water guide tube part.
- the water guide tube is characterized by comprising an eyeball-side water guide tube and an extra-conjunctival water guide tube.
- aqueous humor drainage plant when an aqueous humor drainage plant for treating glaucoma (hereinafter, referred to as “aqueous humor drainage plant”) is installed in a patient, a water guide tube is formed based on the patient's eyeball and the anatomical structure in the vicinity thereof. Parts can be arranged, and can be installed in a minimally invasive and simple manner. That is, in the aqueous humor drainage implant of the present invention, the water guide tube for guiding aqueous humor in the eyeball to a part of the filter outside the eyeball is constituted by the eyeball side water guide tube and the extraconjunctival water guide tube. Therefore, the shape and properties of each tube can be easily adapted to the respective installation positions.
- the above-mentioned eye-side water guide tube placed in a living tissue such as the anterior chamber, the subconjunctiva, or the sclera is required to have appropriate flexibility and high biocompatibility because the movement of the eyeball is small.
- the extraconjunctival water delivery tube is High flexibility and high biocompatibility are required because they are directly susceptible to eye movement and need to adapt to complex extra-ocular anatomical structures.
- the water guide tube part of the present invention is composed of the eyeball side water guide tube part and the extraconjunctival water guide tube part, desired shapes and properties can be easily given to each.
- the connection between the eyeball-side water-conducting tube and the extra-conjunctival water-conducting tube is set near the conjunctival surface.
- the shape and structure of the extra-conjunctival water guide tube to the shape of each patient, it is possible to prevent damage to the eyeball, nasolacrimal duct, etc. even after the installation of the aqueous humor drainage implant .
- a filter is connected to one end (outer conjunctival stump) of the water guide tube of the aqueous humor drainage plant, so that the filter moves backward from outside the eyeball into the eyeball. It is possible to prevent sexual transmission. It can safely connect the inside of the eyeball with the outside of the conjunctiva and drain the aqueous humor.
- the aqueous humor drainage implant of the present invention may be configured such that the outer diameter of the extraconjunctival water guiding tube is smaller than the inner diameter of the lacrimal canaliculus.
- the aqueous conduit can be disposed in the lacrimal canal consisting of the lacrimal canaliculus, lacrimal sac and nasolacrimal duct, and the aqueous humor can be drained into the nasal cavity through the lacrimal canal. For this reason, it is possible to dispose the water guide tube in a minimally invasive manner. In other words, since the portion of the lacrimal duct with the smallest inner diameter is the lacrimal canaliculus, by making its outer diameter smaller than the inner diameter of the lacrimal canaliculus, resection surgery or the like for arranging the above-mentioned extraconjunctival conduit tube is performed.
- the inner diameter of the lacrimal canaliculus is generally about lm ⁇ ! Since the diameter is about 1.5 mm, the outer diameter of the extra-conjunctival water guide tube can be made smaller than the inner diameter of the lacrimal canaliculus by setting the outer diameter of the outer conjunctival water guiding tube within the range of 0.5 mm to 1.5 mm.
- the filter part may have a shape corresponding to the position where the filter is installed, but is preferably a cylindrical shape having an outer diameter smaller than that of the lacrimal canaliculus, similarly to the extraconjunctival water guide tube.
- the aqueous humor drainage implant of the present invention has a structure in which the outer surface of the above-mentioned extraconjunctival water guide tube and a part of the filter are both formed of curved surfaces, and their outer diameters are substantially equal. They may be the same.
- the extra-conjunctival water guide tube and the part of the filter can be easily installed along the eyeball wall, and the obstacle to the conjunctiva and the feeling of foreign matter after the installation can be suppressed. That is, by making the outer conjunctivat tube and the filter have curved outer surfaces, the outer tube of the conjunctiva and a part of the filter are minimally invasive on the conjunctiva. It can be installed.
- the outer surface of the extra-conjunctival water-conducting tube portion and the part of the filter may have a curved surface, for example, a cylindrical shape having substantially the same outer diameter, in other words, the extra-conjunctival water-conducting tube portion. And a part of the filter formed in a single tube.
- the installation position of the aqueous humor drainage plant can be selected according to the patient's situation. It is possible to do.
- the aqueous humor drainage implant of the present invention together with the extraconjunctival water transport tube,
- the part of the filter can be constituted, for example, by directly fitting tubes made of a soft polymer material to each other, or by connecting them via a joint.
- substantially the same outer diameter means that the outer diameters are substantially the same to the extent that the connection via the fitting-joint can be smoothly realized.
- substantially the same outer diameter differs depending on the bending elastic modulus, the ratio of outer diameter / inner diameter, and the like of each soft polymer material constituting the outer conjunctiva water guide tube and the filter section. In other words, it means that the outer diameter of one of the extra-conjunctival water guide tube and the filter part is within twice as large as the other outside diameter, and more preferably within 1.5 times. .
- the aqueous humor drainage implant of the present invention has a structure in which a part of the filter is made of a polyolefin, a polyvinyl alcohol-based polymer, an ethylene-vinyl alcohol-based copolymer, or a polysulfone-based polymer.
- a hollow fiber membrane (hereinafter referred to as “the hollow fiber”) comprising at least one of a polymer material of a polyatarylonitrinole type, a cenorelose type, a phenolyl acetate type, a polymethinolemethacrylate type, and a polyamide type.
- film Abbreviated as “film”.
- the hollow fiber membrane can have a very small membrane pore size, so that the hollow fiber membrane can prevent retrograde infection down to the virus level.
- the average membrane pore diameter of the hollow fiber membrane is preferably 0.3 ⁇ m or less, and more preferably 0.22 ⁇ or less. This ensures that virus particles are captured by the hollow fiber membrane. Can be.
- the “average membrane pore size” of the hollow fiber membrane is converted using a method used for a general hollow fiber membrane for an artificial kidney as shown in the following cited document. (Cited literature: Takeshi Sato et al .: Functions and adaptations of various blood purification methods-Performance evaluation method and functional classification of blood purifiers. "Dialysis Society", published by The Japan Dialysis Medical Association, 29 (8), 1 2 3 1 to 1 2 4 5, 1 996 years)
- the aqueous humor drainage implant of the present invention may be configured such that a part of the filter is formed by chemically bonding an anionic group or a cationic group.
- the ability to block a virus can be improved as compared with a filter that does not process the virus. That is, if the membrane pore size is the same, the virus-blocking ability of the hollow fiber membrane in which the anionic group or the cationic group is chemically bonded by the above-described electrical treatment is larger. For this reason, it is possible to increase the pore diameter of the hollow fiber membrane while maintaining the desired virus blocking ability, and it is possible to easily obtain the amount of aqueous humor drainage necessary for lowering intraocular pressure. Become.
- the aqueous humor drainage implant of the present invention may be one in which the above water guide tube portion and the above filter portion have been subjected to a hydrophilic treatment in order to solve the above problems.
- the biocompatibility between the water guide tube portion and the filter part is improved, and the filter part required to reduce intraocular pressure is also required. It is possible to stably obtain the amount of discharged aqueous humor.
- the aqueous humor drainage implant of the present invention may further comprise a joint for detachably connecting the eyeball-side water guide tube and the extra-conjunctival water guide tube in order to solve the above problem. Good.
- the filter can be replaced if it deteriorates or breaks with the use of the aqueous humor drainage implant. Therefore, compared to the case where the entire aqueous humor drainage implant is re-installed, the effect of lowering the intraocular pressure of the aqueous humor drainage implant is maintained over a long period of time in a simpler, less expensive and less painful way. It becomes possible.
- the shape and installation method of the aqueous humor drainage plant can be adjusted to some extent with respect to individual differences in the patient's eyeball and surrounding tissues.
- the flexural modulus of the above-mentioned extraconjunctival water guide tube at room temperature may be 200 OMpa or less.
- the above invention it is possible to significantly prevent invasion of the eyeball tissue due to eye movement, pain of the patient, and displacement of the installation position of the aqueous humor drainage plant. Become.
- the flexural modulus of the extraconjunctival water conduction tube part of the aqueous humor drainage implant at room temperature not more than 2000 MPa, it easily deforms in response to eye movement and reduces tissue invasion of the eyeball High flexibility can be provided.
- the effects of eye movements are absorbed by the extra-conjunctival water conduction tube, and the extra-conjunctival water conduction tube invades the eyeball tissue, causes pain to the patient, and shifts the installation position of the aqueous humor drainage plant. It can be prevented.
- the aqueous humor drainage implant of the present invention is characterized in that the extraconjunctival water conduction tube is formed by connecting the extraconjunctival ocular-side water conduction tube and the extraconjunctival filter-side water conduction tube.
- the bending elastic modulus at room temperature of the extraconjunctival ocular-side water-guiding tube may be smaller than the bending elastic modulus of the extra-conjunctival filter-side water-guiding tube at room temperature.
- the extra-conjunctival water-conducting tube which is particularly susceptible to eye movement, more reliably absorbs the effect of eye movement, invading the eye tissue accompanying eye movement, suffering from patients, and causing aqueous humor. It is possible to largely prevent the displacement of the placement position of the discharge implant.
- the flexural modulus at room temperature of the extraconjunctival ocular-side conduit tube is smaller than the flexural modulus at room temperature of the extraconjunctival filter-one conduit tube at room temperature.
- the flexural modulus of the tube refers to a value measured and calculated at ordinary temperature by an ordinary method (ASTMD790).
- FIG. 1 is a schematic diagram showing an installation state of the entire eyeball when an aqueous humor drainage plant for treating glaucoma, which is one embodiment of the present invention, is inserted up to the nasolacrimal duct.
- FIG. 2 is an overall view of the glaucoma treatment aqueous humor drainage implant of FIG. 1 in which a plurality of the first half and a second half of the configuration are divided.
- Fig. 3 is a view showing an example in which a plurality of small holes are formed at the tip of the outer cylinder. A part of the filter is cut along the extension direction, and the aqueous humor drainage plant for treating glaucoma of Fig. 1 is shown. A cross-sectional view showing the outline of the structure of a part of the filter ⁇ &.
- FIG. 4 is a cross-sectional view taken along line AA ′ of a part of the filter, schematically showing a structure of a part of the filter of the aqueous humor drainage implant for glaucoma treatment of FIG.
- FIG. 5 is a schematic diagram showing the installation state of the entire eyeball when the aqueous humor drainage plant for glaucoma treatment of FIG. 1 is installed on the conjunctiva.
- FIG. 1 is a schematic view showing an installation state of the entire eyeball when an aqueous humor drainage implant according to an embodiment of the present invention is inserted into a nasolacrimal duct.
- FIG. 2 is an overall view of the aqueous humor drainage plant shown in FIG. 1 in which the first half and the second half of the configuration are separated.
- the aqueous humor drainage plant 1 of the present embodiment mainly includes three parts, a first tube (water supply tube part. Eyeball side water supply tube part) 3, and It consists of 1 joint (joint part) 5, 2nd joint (joint part) 6, and the latter half of the structure 10. 'In the following, the first joint 5 and the second joint 6 are collectively referred to as "joints 5 and 6" unless otherwise specified.
- the aqueous humor drainage plant 1 connects the anterior chamber of the eyeball to the outside of the conjunctiva 14 and the first tube 3 which is the first half of the configuration installed along the scleral wall below the conjunctiva 14 and the inner tube.
- first tube 3 which is the first half of the configuration installed along the scleral wall below the conjunctiva 14 and the inner tube.
- lacrimal sac 24 or lower canaliculus 23
- lacrimal sac 24 or lower canaliculus 23
- nasolacrimal duct 25 It is composed of a second half 10 of the configuration to be installed, and joints 5 and 6 for connecting the first tube 3 as the first half of the configuration and the second half 10 of the configuration. Note that FIG.
- the conjunctiva 14 includes the bulbar conjunctiva, the conjunctival fornix, and the eyelid conjunctiva.
- the second half of the configuration 10 is the second tube (water conduction tube part, extraconjunctival water conduction tube part, extraconjunctival water conduction tube part) 7, the third tube (water conduction tube part, extraconjunctival water conduction) Tube part, extra-conjunctival filter-side water guide tube part) 8 and filter part 9.
- the first tube 3, the second tube 7, and the third tube 8 correspond to the water guide tube part of the present invention, and the filter part 9 corresponds to the filter part of the present invention.
- the joints 5 and 6 correspond to the joint portion of the present invention
- the second tube 7 and the third tube 8 correspond to the extraconjunctiva water guiding tube portion.
- the second tube 7 and the third tube 8 correspond to the extra-conjunctival ocular-side water conduit tube portion and the extra-conjunctival filter-side water conduit tube portion, respectively.
- the aqueous humor is guided from the anterior chamber of the eyeball to the joints 5 and 6 through the first tube 3.
- the aqueous humor goes out of the conjunctiva 14 and then passes through the latter half of the configuration 10 to the upper lacrimal canaliculus 2 (or lower canaliculus 23), lacrimal sac 24, and nasolacrimal duct 2 5 Will be discharged to one of the
- the aqueous humor discharged from the aqueous humor drainage implant 1 is connected to the nasolacrimal duct 25 and the nasolacrimal duct 25 via the upper lacrimal canaliculus 22 (or the lower lacrimal canaliculus 23) and the lacrimal sac 24. Absorbed in the nasal cavity (not shown).
- FIG. 1 shows a case in which aqueous humor is absorbed in the nasal cavity through the second half of the composition 10, but is discharged onto the conjunctiva 14 through the second half of the composition 10 as described later. It can also be configured to be. In this case, the discharged aqueous humor is absorbed by the conjunctival 14 tissue.
- the first tube 3 which is the first half of the configuration, has an inner diameter of 0.5 mm, an outer diameter of 1.0 mm, and a length of 1.0 mm. It is composed of a single 10 mm silicon tube, which is connected to the joint 5 at the outer conjunctival stump 4.
- the first tube 3 is placed along the scleral wall under the conjunctiva 14 by a surgical operation. At this time, the anterior chamber inner end 2 of the first tube 3 is placed in front of the eyeball. It is inserted into the chamber, and the conjunctiva outer stump 4 and the joint 5 are placed outside the conjunctiva 14 at the inner eye corner 26.
- the conjunctiva 14 and the subconjunctival tissue are incised in a valve shape, and the sclera 16 Expose. At this time, stop bleeding if necessary. Then, the outer conjunctival stump 4 of the first tube 3 of the aqueous humor drainage implant 1 is sutured and fixed to the scleral wall of the inner corner 26 of the eye. The anterior chamber inner stump 2 of the first tube 3 of the aqueous humor drainage implant 1 is then passed through the sclera 16 using a known method, and between the iris 17 and the cornea 15. To be installed.
- the first tube 3 is appropriately sutured and fixed to the scleral wall so that it can be installed in a shape as shown in FIG. Put back the conjunctiva 14 and close the incision with suture.
- the conjunctiva around the conjunctival outer stump 4 of the first tube 3 is exposed so that the first joint 5 connected to the conjunctival outer stump 4 of the first tube 3 is exposed outside the conjunctiva 14.
- 14 is closed using a known method such as a purse string suture or a biological adhesive.
- the material of the first tube 3 is moderately flexible. Any material that has high biocompatibility may be used.
- the first tube 3 include polyolefin resins such as silicone resins, polyethylene, polypropylene, polyisobutylene, ethylene acetate vinyl copolymer, polynorbornene, and the like.
- polyolefin resins such as silicone resins, polyethylene, polypropylene, polyisobutylene, ethylene acetate vinyl copolymer, polynorbornene, and the like.
- synthetic rubbers such as urethane resin, polypropylene, polyisoprene, SBR (Styrene Butadiene Rubber) and SIR, various types of polymer materials such as natural rubber and the like can be mentioned. From the viewpoints of use results and reliability, among the materials exemplified above, silicone resins and polyurethane resins are preferred. Used.
- the outer diameter of the first tube 3 be substantially the same as the outer diameter of the rear half portion 10 to be subsequently connected.
- the outer diameter of the first tube 3 is generally about 0.5 to 1.5 mm although there are individual differences. That is, the appropriate outer diameter of the first tube 3 varies depending on the patient to which the aqueous humor drainage implant 1 is to be installed, but generally falls within a range of about 0.5 to 1.5 mm. Further, the length of the first tube 3 depends on the position at which the inner stump 2 of the anterior chamber is inserted into the anterior chamber, but is generally about 5 to 20 mm.
- the first tube 3 is fixed along the scleral wall.
- a structure using any known technique may be installed in the first tube 3 as long as the method achieves the purpose of facilitating the fixing operation.
- An example of a structure using such a known technique includes a protrusion-like structure provided on the outer surface of the first tube 3.
- the first tube 3 can be fixed along the scleral wall using the projection-like structure, so that the fixing operation can be facilitated.
- the conjunctiva outer end 4 of the first tube 3 is to be connected to the first joint 5, but it is necessary that the conjunctiva outer stump 4 and the first joint 5 be integrally fixed in advance. desirable. As a result, the surgical procedure can be further simplified, and infection from the connection portion can be more reliably prevented.
- the aqueous humor drainage implant of the present embodiment As shown in FIGS. 1 and 2, the aqueous humor drainage implant of the present embodiment
- the second half 10 of the configuration 1 is composed of three parts. That is, the second half of the configuration 10 is composed of a second tube 7 connected to the second joint 6, a filter unit 9, and a third tube 8 connecting the second tube 7 and the filter part 9, It is composed of three parts. And after this configuration, the latter half of the configuration is divided into the upper canaliculus 22, the lower canaliculus 23, the lacrimal sac 24, the nasolacrimal duct 25, and the conjunctiva 14 can be installed in a minimally invasive manner, which is an effect that cannot be realized with a conventional aqueous humor drainage plant.
- the human body has a canaliculus, called the lacrimal passage through which tear fluid passes, from the inner eye corner 26 to the nasal cavity (not shown).
- This lacrimal passage has a diameter of about 1 mm to 1.5 mm and a length of 1 ⁇ ⁇ !
- Single tubular structure of ⁇ 3 Omm consisting of upper punctum 20, lower punctum 21, upper canaliculus 22, lower canaliculus 23, lacrimal sac 24 and nasal lacrimal duct 25 It connects (communicates) the inner canthus 26 with the nasal cavity.
- the tears pass through the lacrimal canal and are discharged into the nasal cavity.
- the present invention focuses on the anatomical features of the lacrimal canal, and it is possible to insert the latter half of the structure into the lacrimal canal and install it It was made.
- the aqueous humor drainage implant 1 of the present embodiment discharges the aqueous humor of the anterior chamber into the nasal cavity by using the existing lacrimal passage while maintaining the natural structure, It would be possible to achieve a non-invasive installation that could not be achieved.
- by forming the shape of the rear half portion 10 into a single tube shape that can penetrate into the lacrimal passage it is possible to penetrate the lacrimal passage in a minimally invasive manner.
- the effect of the aqueous humor drainage plant 1 of the present embodiment can be achieved.
- FIG. 5 is a schematic diagram showing an installation state of the entire eyeball when the aqueous humor drainage plant 1 of the present embodiment is installed on the conjunctiva. Note that the same reference numerals are given to members and portions having the same functions as those in FIG. 1 and description thereof is omitted.
- the second half of the configuration 10 when the second half of the configuration 10 is placed on the conjunctiva 14, in addition to the invasion at the time of installation, the second half 10 of the configuration after installation may cause damage to the corneal conjunctiva, You must consider the feeling of foreign objects.
- the aqueous humor drainage plant instead of simply placing the aqueous humor drainage plant in the conjunctival sac and placing it in the conjunctival sac as shown in Fig. 5, it is placed on the conjunctiva 14 along the curved surface of the eyeball wall as in the prior art. The effects of exercise need to be minimized.
- the first half of the configuration can be simply placed along the eyeball wall by forming the latter half of the tube into a single tube shape, and the obstacle to the conjunctiva 14 after the installation and the feeling of foreign matter can be suppressed, and This has the effect of being minimally invasive on the conjunctiva 14.
- the latter half of the configuration 10 is placed on the conjunctival fornix 27 of the conjunctiva 14.
- the second half of the configuration 10 is composed of three parts, but the number of the plurality of parts constituting the second half of the configuration 10 is not limited to this.
- the shape of the second half of the configuration 10 is a single tube, and the second half of the configuration 10 is composed of a plurality of parts, specifically, the second tube 7, the third tube 8, and the filter. Beginning by dividing the part 9 into three parts, the latter half of the structure 10 is on the upper lacrimal canaliculus 2, lower lacrimal canaliculus 23, lacrimal sac 24, nasal lacrimal canal 25, and conjunctiva 14 Any of the above can be an aqueous humor drainage implant 1 that can be installed in a minimally invasive manner.
- the single tube shape of the second half of the configuration 0 will be described later in detail.
- the outer diameter of the rear half portion 10 is desirably substantially the same as the outer diameter of the first tube 3, and is generally preferably about 0.5 to 1.5 mm.
- each of the second tube 7 and the third tube 8 has a silicon diameter of 0.5 mm s and an external diameter of 1.0 mm. It is a tube.
- the second half of the configuration 10 is configured to include two silicon tubes.
- the length of the second tube 7 is 5 mm
- the length of the third tube 8 is 10 mn! ⁇ 30 mm.
- the filter part 9 includes, for example, an outer cylinder of a polyethylene tube having an inner diameter of 0.8 mm, an outer diameter of 1.0 mm, and a length of 10 mm, and an outer diameter of 0.7 arranged in the inner cavity. It consists of a single hollow fiber membrane of 8 mm in length and 8 mm in length.
- the filter part 9 can be made into a single tube shape similar to the second tube 7 ′ and the third tube 8.
- the shape and dimensions of the second tube 7, the third tube 8, and the filter part 9 of the latter half of the configuration 10 described above are the same as those of the latter half of the configuration. It was designed based on the anatomical basis of the lacrimal canal described above so that it can be installed in a minimally invasive manner in any of the small canals 23, lacrimal sac 24, and nasolacrimal duct 25. It has been devised based on the anatomical basis of the eyeball described above so that the second half of the configuration 10 can be placed on the conjunctiva 14 in a minimally invasive manner.
- the latter half of the configuration 10 can be surgically performed, depending on the patient's situation, by upper canaliculus 22, inferior canaliculus 23, lacrimal sac 24, nasolacrimal duct 25, or conjunctiva 1 4 Installed anywhere. As shown in Fig.
- the second tube 7 is installed so as to be located outside the upper punctum 20 (lower punctum 21) for the purpose of eye movement as described later. Then, the end of the second tube 7 is connected to the first joint 5 using the second joint 6. In addition, as shown in FIG. 5, when the second half of the structure 10 is to be placed on the conjunctiva 14, the end of the second tube 7 is cut into the first by using the second second joint 6. Connect the joint 5 and place the latter half 10 on the conjunctiva 14. In FIGS. 1 and 5, 18 denotes the upper eyelid 18 and 19 denotes the lower eyelid 19. I have.
- the patient's condition is a condition in which the nasolacrimal duct is obstructed, the discharged aqueous humor affects the visual acuity, and the foreign body sensation due to the latter half of the configuration 10 is felt.
- the latter half of the configuration 10 is placed on the conjunctiva 14 .
- the discharged aqueous humor affects visual acuity, or if foreign body sensation (discomfort) is inevitably caused by the second half of the configuration during eye movement, the second half of the configuration is connected to the upper canaliculus. 22 It is desirable to place it in any of the lower canaliculus 23, lacrimal sac 24, and nasolacrimal duct 25.
- the second joint 6 and the rear half portion 10 of the structure are integrally fixed in advance. As a result, the surgical procedure can be made simpler, and infection from the connection between the second joint 6 and the rear half 10 can be more reliably prevented.
- the subsequently installed second tube 7 is directly affected by the mechanical effect of eye movement.
- the expansion and contraction of the second tube 7 is insufficient with respect to the movable range of the eyeball, the eyeball movement is restricted, and the possibility of double vision and the displacement of the installation position of the aqueous humor drainage plant 1 are made. May occur.
- the second tube 7 can sufficiently cope with eye movements, particularly high elasticity, Flexibility and deformability are required. That is, the material of the second tube 7 needs to be a material having high elasticity, flexibility, and deformability. In addition, the second tube 7 may temporarily come into contact with eye tissue mainly of the cornea depending on the movable range of the eye. At this time, it is important to ensure that the second tube 7 has sufficient elasticity, flexibility, and deformability in order to prevent the eyeball tissue from being damaged by the second tube 7. It is.
- the material used for the second tube 7 is required to have high flexibility and high biocompatibility that easily deform in response to eye movement and reduce tissue invasion of the eye.
- any material may be used as long as it has high elasticity, flexibility, deformability, and biocompatibility
- a typical example is a silicone-based material.
- examples include various polymer materials such as resins, polyolefin resins such as polyethylene, polypropylene, polyisobutylene, ethylene-butyl acetate copolymer, polynorbornene, and the like, polyurethane resins, natural rubber, and synthetic rubber.
- silicone resins and polyurethane resins are preferably used.
- the outer diameter of the second tube 7 is desirably substantially the same as that of the other first tube 3 and the third tube 8, and the length thereof is determined by the positions of the joints 5 and 6 and the length of the rear half 10 of the configuration. Although it depends on the installation site, it is generally about 5 mm to 2 Omra in consideration of expansion and contraction due to eye movement. Further, it is more preferable that the second joint 6 and the second tube 7 are integrally fixed in advance. This makes surgical procedures easier Thus, infection from the connection between the two can be more reliably prevented.
- the third tube 8 is placed in a living tissue such as the conjunctiva 14, upper punctum 20, lower punctum 21, upper canaliculus 22, lower canaliculus 23, and lacrimal sac 24
- the material of the third tube 8 needs to be a material having appropriate flexibility and high biocompatibility.
- any material may be used as the material of the third tube 8, but typical examples thereof include silicone resin, polyethylene, and polypropylene.
- examples include various polymer materials such as polyolefin-based resins such as pyrene, polyisobutylene, and ethylene-vinyl acetate copolymer, polyurethane-based resins, synthetic rubber, and natural rubber.
- the outer diameter of the third tube 8 is determined by considering that the tube 8 is placed in the upper lacrimal canaliculus 22, lower lacrimal canaliculus 23, lacrimal sac 24, and nasolacrimal duct 25. It is required that the inner diameter of the punctum 21, the upper lacrimal canaliculus 22, the lower lacrimal canaliculus 23, and the lacrimal sac 24 be thinner.
- the inner diameter of each tube varies depending on the patient, but the outer diameter of the third tube 8 is generally 0.5 mn! It is desirably about 1.5 mm.
- the length of the third tube 8 is generally 5 mm to 20 mm, depending on the installation position of the rear half 10 of the structure and the individual differences of patients.
- Each of the second tube 7 and the third tube 8 has a flexural modulus at room temperature of 200 Mpa or less, has high flexibility, and has a high flexibility in eye tissue accompanying eye movement. Invasion, patient distress, and displacement of the aqueous humor drain plant 1 can be prevented. Further, in the present embodiment, the second tube 7 and the third tube 8 are formed of the same bending elastic modulus at room temperature, that is, the same flexibility. Ju It is more preferable that the flexural modulus at room temperature is smaller than that of the groove 8. As a result, the effect of eye movement can be more reliably absorbed by the second tube 7.
- the installation position of the third tube 8 may be affected by the elasticity of the second tube 7 and the behavior of the filter section 9 in the nasolacrimal duct 25.
- the second half of the structure 10 is placed in any of the upper lacrimal canaliculus 22, the lower canaliculus 23, the lacrimal sac 24, and the nasolacrimal canal 25, the upper lacrimal canal 20 or the lower lacrimal canal From point 21, a situation may occur in which the third tube 8 is pulled into the nasolacrimal duct 25, or conversely.
- the second half of the configuration 10 In order to surely prevent the occurrence of the above-mentioned situation, it is sufficient to fix the second half of the configuration 10 at an appropriate position.
- the method of fixing the second half of the configuration 10 is not particularly limited, and a conventionally known configuration can be adopted.
- the second half of the configuration 10 may be formed of the upper lacrimal canaliculus 22 and the lower lacrimal canaliculus.
- the third tube 8 can be omitted if necessary, and the second tube 7 and the filter part 9 can be short-circuited. is there.
- the second half of the configuration 10 will become conjunctival with the eye movement. 14
- the installation position will be unstable, deviating from above. Something like this This condition can be prevented by fixing the second half of the configuration 10 at an appropriate position on the conjunctiva 14.
- FIG. 3 is a cross-sectional view schematically showing the structure of a filter section obtained by cutting a part of the filter 9 of the aqueous humor drainage implant 1 of the present embodiment along the extension direction.
- the filter part 9 of the aqueous humor drainage implant 1 of the present embodiment is composed of a hollow fiber membrane part 11 and an outer cylinder part 12.
- the outer cylinder part 12 is provided according to the hardness of the hollow fiber membrane part 11, it is also possible to configure the filter part 9 only with the hollow fiber membrane part 11.
- FIG. 4 is a cross-sectional view taken along the line AA ′ of the filter unit, schematically showing the structure of a part of the filter of the aqueous humor drainage implant of FIG.
- the filter part 9 of the present embodiment has a hollow fiber membrane part 11 disposed inside an outer cylinder part 12.
- the outer diameter of the filter section 9 is determined in consideration of the placement of the upper lacrimal canaliculus 22, the lower lacrimal canaliculus 23, the lacrimal sac 24, and the nasolacrimal duct 25. 1, Upper lacrimal canaliculus 2, lower lacrimal canaliculus 23, and lacrimal sac 24 must be smaller than the inner diameter. These inner diameters vary from patient to patient, but are generally 0.5 mix! Therefore, it is desirable that the outer diameter of the filter part 9 is also about 0.5 mm to 1.5 mm. In addition, although there are individual differences among patients, the length of the filter part 9 is generally about 5 mm to 20 mm. When the filter part 9 is composed only of the hollow fiber membrane part 11, the outer diameter of the filter part 9 is the outer diameter of the hollow fiber membrane part 11, and In the case of including the outer cylindrical portion 12, the outer diameter of the filter portion 9 is the outer diameter of the outer cylindrical portion 12.
- the hollow fiber membrane portion 11 is open at the connection portion with the third tube 8, while the cut end 13 is closed and becomes a blind end.
- all aqueous humor flowing out of the anterior chamber of the eye via the aqueous humor drainage implant 1 passes through the hollow fiber membrane 11 and passes through the small hole on the side of the hollow fiber membrane 11 to filter. It will be discharged outside part 9.
- any conventionally known method may be used as long as the stump 13 can be closed. Examples of such a method include a closing method using a polyurethane adhesive and a closing method using heat welding.
- the hollow fiber membrane portion 11 of the filter part 9 drains aqueous humor to lower intraocular pressure, and at the same time, viruses, bacteria, fungi, etc. existing outside the conjunctiva 14 It also prevents intrusion into the inside of the tube 3 and the rear half 10 of the structure. This can lower intraocular pressure and prevent retrograde infection from occurring outside of the conjunctiva 14 at this time.
- the condition of the hollow fiber membrane part 11 required from the viewpoint of aqueous humor drainage is that the production rate of aqueous humor is 2.0 ⁇ 1 / mil! 33 ⁇ m / min, and the target intraocular pressure is about 10.0 mmHg to 20.0 mmHg. Therefore, 1 0 in the hollow fiber membrane unit 1 1. 0 mmHg ⁇ 2 0. 2 at 0 mmH about water pressure. 0 ⁇ l / min ⁇ 3. 0 ⁇ 1 / min or more aqueous humor drainage flow is obtained This is the condition of the hollow fiber membrane section 11.
- the amount of aqueous humor flowing out under a constant water pressure was measured using the hollow fiber membrane used for the hollow fiber membrane part 11 constituting the aqueous humor drainage plant 1 of the present embodiment.
- a vertically installed pipe is filled with BSS Plus (Santen Pharmaceutical Co., Ltd.), which is a commercially available pseudo-aqueous humor, to a height of about 13 cm from the bottom of the pipe.
- the weight of BSS Plus flowing out per unit time was measured by connecting the hollow fiber membrane unit 11.
- the volume of the outflowing BSS Plus was calculated from the weight of the outflowing BSS Plus and the specific gravity of the BSS Plus.
- the hollow fiber membrane used as the hollow fiber membrane part 11 two kinds of prototype EVAL membranes having different average pore diameters and outer diameters were used. The above experiment was conducted while maintaining the temperature of BSS plus at 37 degrees.
- the above-mentioned prototype EVAL membrane is an ethylene-vinyl alcohol-based copolymer with an ethylene content of 32 mol% and a saponification degree of 99 mol% (EV manufactured by Kuraray Co., Ltd.).
- the above-mentioned stock solution is a transparent and homogeneous solution at a high temperature, but when the temperature is lowered, phase separation occurs and the solution becomes cloudy, and when left for a long time, it separates into two layers.
- the temperature at which this phase separation starts to occur is called LST.
- the hollow fiber membrane E1 as the above-mentioned prototype EVAL membrane was produced by a method of performing washing with water, wet heat treatment, drying and heat treatment to obtain a dry hollow fiber membrane according to a conventional method.
- the details of the method of producing the prototype Eval membrane that is, the ethylene-vinyl alcohol-based polymer hollow fiber membrane, are described in JP-A-13-286740 ⁇
- the hollow fiber membrane E was prepared as described above.
- Table 1 shows the results of the evaluation experiments for the average membrane pore diameter and outer diameter of l and E2.
- the simulated aqueous humor corresponding to the production rate of aqueous humor described above was obtained.
- the amount of spill that meets the conditions for spill was recognized.
- the aqueous humor drainage implant 1 of the present invention is effective for draining aqueous humor such that the intraocular pressure can be maintained within a normal range.
- the aqueous humor drainage by the aqueous humor drainage plant 1 of the present invention may be excessive.
- a pressure-opening / closing check valve or a pressure-regulating valve may be appropriately connected to the first tube 3, the first joint 5, Second joint 6 or may be incorporated in the latter half of the configuration 10 o
- the pressure open / close type check valve opens and closes to maintain the intraocular pressure within the range of normal intraocular pressure of about 7 mmHg to 20 mmHg.
- the pressure-operated check valve may be of any known technology as long as it achieves this purpose, such as the slit type used in the Krupin-Denver eye shunt.
- Check valve US Pat. No. 5,454,796
- check valve used in Ahmed glaucoma implant US Pat. No. 5,071,408, US Pat. 26, 256, and the like.
- valve of the pressure open / close type check valve is a check valve
- the aqueous humor can be used under conditions where the nasolacrimal duct pressure is expected to rise rapidly, such as when the nose is blown or when sneezing. Backflow can be prevented.
- the condition of the hollow fiber membrane of the hollow fiber membrane 11 required from the viewpoint of preventing retrograde infection by viruses and microorganisms is such that the diameter of the virus particle is 0.02 ⁇ ! Considering that the diameter of the hollow fiber membrane is about 0.3 ⁇ m, the average pore diameter of the hollow fiber membrane is 0.3 m or less, preferably 0.3 ⁇ ! Within the range of 0.02 ⁇ , more preferably 0.. ⁇ ⁇ ⁇ ⁇ ! ⁇ 0.01 m. If the average membrane pore size of the hollow fiber membrane is larger than the above range, it is highly likely that it will be difficult to block virus particles.
- the condition of the average membrane pore diameter of the hollow fiber membrane is a condition that can be flexibly adjusted within a range in which the purpose of the hollow fiber membrane part 11 is to achieve retrograde infection prevention at the virus level. That is, when a function of electrically blocking viruses is added to the hollow fiber membrane section 11 as described later, virus capture is achieved by reducing the average membrane pore diameter of the hollow fiber membrane, This will be done by the capture. For this reason, the hollow fiber membrane used in the hollow fiber membrane portion 11 has a function of preventing retrograde infection at the virus level even if the average membrane pore size is larger than the above range. There is no problem if you can do it.
- any material that has an appropriate water permeability and can prevent retrograde infection down to the virus level can be used.
- hollow fiber membranes are used in a wide variety of applications, but are mainly used for artificial kidneys in the medical field.
- the average membrane pore size of the hollow fiber membrane for artificial kidney is about 0.05 ⁇ to about 0.08 ⁇ m, and the hollow fiber membrane constituting the aqueous humor drainage plant 1 of the present invention. It can be said that the above-mentioned conditions required for the hollow fiber membrane of Part 11 are satisfied. Therefore, it can be appropriately selected from among the industrially produced hollow fiber membranes for artificial kidney, and used as the hollow fiber membrane constituting the present invention.
- hollow fiber membranes for artificial kidneys include APS-150, AM—FP—130, AM—GP—13, AM—UP—13 (all made by Asahi Medical Co., Ltd.), Meltral 40 Meltraxl 60 (all made by Izumi Medical Co., Ltd.), Used in dialysis machines such as FB-130 U (manufactured by Nipro Corporation), BS-1.6 (manufactured by Toray Industries, Inc.) and PS-1.6 N (manufactured by Kawasumi Chemical Industry Co., Ltd.) Hollow fiber membranes (Seisuke Takashima, “Characteristics Required for Membrane Materials”, Clinical Engineering, 1997, Vol. 8, No. 6, p479—492 reference).
- the ability to electrically block the virus is also required. It is also possible to add to the hollow fiber membrane part 11.
- the whole virus particle like many bacteria, is negatively charged under normal pH neutral conditions. Therefore, when anionic groups are chemically bonded to (introduced into) the hollow fiber membrane portion 11 and charged negatively, the virus particles are electrically repelled by the negative ions present in the hollow fiber membrane. To prevent membrane passage.
- a cationic group is chemically bonded to the hollow fiber membrane 11 to positively charge the virus. The virus particles are electrically attracted and adsorbed to the positive ions present in the hollow fiber membrane. As a result, the membrane is prevented from passing through.
- protein one of the components of the virus, is an amphoteric electrolyte and has both a cationic group (mainly an amino group) and an anion group (mainly a carboxyl group).
- An anionic group or a cationic group chemically bonded to the hollow fiber membrane part 11 is presumed to trap an amino group or a carboxyl group in the protein as a counter ion by the same mechanism as the ion exchange membrane. It is.
- to electrically block a virus means to prevent virus particles from passing through a hollow fiber membrane by using the above-described electric force.
- a larger membrane pore diameter (average) can be obtained compared to a non-charged membrane to which such electrical performance is not added. (Pore diameter of the membrane) can be prevented from passing through the virus.
- the method of introducing an ionic group into the hollow fiber membrane 11 may be any method that can introduce an ionic group into the hollow fiber membrane of the hollow fiber membrane 11.
- ionic groups such as a sulfate group, a carboxyl group, and an amino group can be easily introduced by utilizing reactions such as esterification, etherification, and addition of Mikle.
- the outer cylinder part 12 may be added to the hollow fiber membrane part 11 as necessary to simplify installation outside the conjunctiva 14 and increase the durability of the filter part 9. It is possible to provide.
- the outer cylindrical portion 12 has a plurality of small holes formed at the tip (cut end) thereof, and the small holes are discharged from the side surface of the hollow fiber membrane portion 11. Aqueous humor is allowed to pass.
- the outer cylinder 1 Although a plurality of small holes are provided at the end of the outer tube portion, the small holes provided in the outer cylindrical portion 12 are not limited thereto, and may be any as long as the aqueous humor can be passed. For example, one having one or more holes (small holes) on its side surface, one having one or more holes (small holes) on its side surface and its tip, etc. 2 can be used.
- any material may be used as the material of the outer cylinder portion 12 as long as it is a material having appropriate hardness and high biocompatibility.
- Examples include silicone resin, polyethylene resin, and polypropylene.
- Polymer materials such as resin-based resin, polyvinyl alcohol-based resin, ethylene vinyl alcohol copolymer, polyurethane-based resin, synthetic rubber, natural rubber, trans-polyisoprene-based resin, and polycarbonate-based resin.
- silicone-based resins, polyurethane-based resins, and transpolyisoprene-based resins are preferably used.
- the latter half portion 10 can be subjected to a hydrophilic treatment.
- a hydrophilic treatment any known method may be used, and examples thereof include surface grafting, oxidation treatment, acid treatment, alkali treatment, and microcle addition reaction. .
- the material of the joints 5 and 6 is highly biocompatible and durable It is preferable to use a material having excellent properties. If such a material is used, any material may be used for the joints 5 and 6, but examples thereof include polyacetal resin, silicone resin, polyethylene resin, polypropylene resin, and ethylene resin.
- Examples include polymer materials such as butyl alcohol copolymer, polyurethane resin, ABS (Acrylonitrile-Butadiene-Styrene) resin, polycarbonate resin, and ceramics such as alumina and titania, and metals such as stainless steel.
- polymer materials such as butyl alcohol copolymer, polyurethane resin, ABS (Acrylonitrile-Butadiene-Styrene) resin, polycarbonate resin, and ceramics such as alumina and titania, and metals such as stainless steel.
- the joints 5 and 6 may be formed by any known technique as long as the structure achieves the purpose of connecting the first tube 3 and the second tube 7 of the rear half 10 of the structure while preventing foreign matter from entering from outside. Although it may be used, examples thereof include a tapered connector, a screw-type connector, a ball-type joint, a coupler (manufactured by Nitto Ekki Co., Ltd.), and a tube filter (manufactured by Nitto Eki Co., Ltd.). Is mentioned. Particularly desirable joints 5 and 6 have a structure that can be easily attached and detached and that the sound and the response make it easy to confirm the attachment / detachment operation.
- the size and shape of the joints 5 and 6 may be any size and shape as long as they can suppress invasion of the conjunctiva 14 and upper eyelid 18 and lower eyelid 19 due to eye movement. It does not matter, but as such an example, the size is about 1 to 5 cubic millimeters, and the shape may be a curved surface as shown in FIG. By setting the size and shape of the joints 5 and 6 as described above, invasion to the living body can be minimized.
- the aqueous humor drainage plant of the present invention can also be implemented as one having the following configuration.
- a first aqueous humor drainage plant for discharging aqueous humor from the eyeball to the outside of the conjunctiva characterized by having a shape; according to the above invention, minimally invasive and simple aqueous humor drainage Implants can be placed, and the aqueous humor can be drained out of the conjunctiva safely and reliably.
- the first aqueous humor drainage implant may have a shape and structure that can be placed in the lacrimal canaliculus, lacrimal sac, or nasolacrimal duct. Or the first The aqueous humor drainage plant may have a shape and structure that can be installed on the conjunctiva.
- the installation position of the aqueous humor drainage implant can be selected from the conjunctiva, the lacrimal canaliculus, the lacrimal sac, and the nasolacrimal duct according to the patient's condition. Can be installed in a minimally invasive manner.
- the first aqueous humor drainage implant may use a hollow fiber membrane that prevents retrograde infection up to the virus level in a part of the filter.
- the first aqueous humor drainage implant may use a hollow fiber membrane that has been subjected to a treatment for electrically blocking microorganisms such as viruses in a part of the filter.
- the first aqueous humor drainage plant may be one whose outer surface is subjected to a hydrophilic treatment.
- the first aqueous humor drainage plant may include a joint that allows a part of the filter to be replaced as necessary. According to the above-mentioned invention, it is possible to replace the filter part for deterioration or breakage of a part of the filter. In other words, compared to the case where the entire aqueous humor drainage plant is re-installed, it is possible to maintain the effect of lowering the intraocular pressure of the aqueous humor drainage plant for a long time in a simpler, less expensive and less painful way. It becomes.
- the first aqueous humor drainage plant has a tube that has a flexibility to easily deform in response to eye movement and reduce tissue invasion of the eye in a portion of the water guide tube portion installed outside the conjunctiva. May be included as a part of the configuration.
- the water guide tube portion is composed of the eyeball-side water transfer tube portion and the extraconjunctival water transfer tube portion.
- the water guide tube is arranged based on the anatomy of the patient's eyeball and near it, making it minimally invasive and easy to install This has the effect of being able to
- the outer diameter of the extra-conjunctival water guide tube may be smaller than the inner diameter of the lacrimal canaliculus. This allows the lacrimal canaliculus, lacrimal sac By disposing the water guide tube in the lacrimal tract, the aqueous humor can be discharged into the nasal cavity through the lacrimal tract. For this reason, there is an effect that the water introduction tube can be disposed in a minimally invasive manner.
- both the outer conjunctiva water guide tube and the filter part may have a curved outer surface, and may have substantially the same outer diameter.
- Some of the above filters are polyolefin-based, polyvinyl alcohol-based polymer, ethylene-vinyl alcohol-based copolymer, polysulfone-based, polyacrylonitrile-based, cenorellose-based, and senorelose-acetate.
- a hollow fiber membrane made of at least one of a polymer material of a polymethacrylate, a polymethylmethacrylate or a polyamide type.
- the average membrane pore size of the hollow fiber membrane is preferably 0.3 ⁇ or less, and more preferably 0.02 ⁇ or less. This has the effect that retrograde infection down to the virus level can be prevented by the hollow fiber membrane.
- a part of the filter may be formed by chemically bonding an anionic group or a cationic group. This has the effect of ensuring that the prevention of retrograde infection down to the virus level can be obtained, and at the same time, the amount of aqueous humor required to lower intraocular pressure can be obtained.
- the water guiding tube part and the filter part may be subjected to a hydrophilic treatment. This has the effect of increasing the biocompatibility and stably obtaining the amount of aqueous humor discharged from the filter, which is required to lower intraocular pressure.
- the aqueous humor drainage plant for glaucoma treatment according to the present invention may further include a joint portion that detachably connects the eyeball-side water-guiding tube portion and the extra-conjunctival water-guiding tube portion.
- the extra-conjunctival water guide tube may have a flexural modulus at room temperature of 2000 MPa or less. Further, the extra-conjunctival water-conducting tube is formed by connecting the extra-conjunctival ocular-side water-conducting tube with the extra-conjunctival filter-side water-conducting tube. However, it may be smaller than the flexural modulus of the extraconjunctival filter-side water guide tube at room temperature.
- the aqueous humor drainage implant for glaucoma treatment is useful as a glaucoma treatment device because it can be installed in the eye and outside the conjunctiva with minimal invasiveness.
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/540,424 US20060235367A1 (en) | 2002-12-27 | 2003-12-18 | Aqueous humor drainage implant for treatment glaucoma |
EP03780911A EP1576941A1 (en) | 2002-12-27 | 2003-12-18 | Aqueous humor drainage implant for treating glaucoma |
CA002511602A CA2511602A1 (en) | 2002-12-27 | 2003-12-18 | Aqueous humor drainage implant for treating glaucoma |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2002381239A JP2004208898A (ja) | 2002-12-27 | 2002-12-27 | 緑内障治療用房水排出インプラント |
JP2002-381239 | 2002-12-27 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2004060219A1 true WO2004060219A1 (ja) | 2004-07-22 |
Family
ID=32708475
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP2003/016284 WO2004060219A1 (ja) | 2002-12-27 | 2003-12-18 | 緑内障治療用房水排出インプラント |
Country Status (5)
Country | Link |
---|---|
US (1) | US20060235367A1 (ja) |
EP (1) | EP1576941A1 (ja) |
JP (1) | JP2004208898A (ja) |
CA (1) | CA2511602A1 (ja) |
WO (1) | WO2004060219A1 (ja) |
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US10070991B2 (en) | 2013-11-28 | 2018-09-11 | Kaneka Corporation | Lacrimal duct tube |
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JPWO2015079999A1 (ja) * | 2013-11-28 | 2017-03-16 | 株式会社カネカ | 涙道チューブ |
WO2019195419A1 (en) | 2018-04-03 | 2019-10-10 | Jack Chu | A new ocular device and method for glaucoma treatment |
EP3773377A4 (en) * | 2018-04-03 | 2021-12-01 | Jack Chu | NEW EYE DEVICE AND GLAUCOMA TREATMENT METHOD |
US11446179B2 (en) | 2018-04-03 | 2022-09-20 | Jack Chu | Ocular device and method for glaucoma treatment |
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US20060235367A1 (en) | 2006-10-19 |
CA2511602A1 (en) | 2004-07-22 |
JP2004208898A (ja) | 2004-07-29 |
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