CA2115263A1 - Eye filtration prosthesis for relieving intraocular pressure - Google Patents
Eye filtration prosthesis for relieving intraocular pressureInfo
- Publication number
- CA2115263A1 CA2115263A1 CA002115263A CA2115263A CA2115263A1 CA 2115263 A1 CA2115263 A1 CA 2115263A1 CA 002115263 A CA002115263 A CA 002115263A CA 2115263 A CA2115263 A CA 2115263A CA 2115263 A1 CA2115263 A1 CA 2115263A1
- Authority
- CA
- Canada
- Prior art keywords
- eye
- flow
- fluid
- prosthesis
- valve
- Prior art date
- Legal status (The legal status 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 status listed.)
- Abandoned
Links
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
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
- Y10S623/902—Method of implanting
- Y10S623/905—Eye
Abstract
A technique and device for relieving intraocular pressure with a reduced risk of inflammation that may be caused by retrograde flow back into the eye. A unidirectional drainage device (50) is implanted which allows fluid flow away from the eye with a minimal pressure gradient (5 mm Hg. or less), and includes means to prevent retrograde flow. When implanted, the drainage passageway is initially restricted by a flow restrictor (53) at a point downstream from the minimal pressure gradient unidirectional valve (56).
Between valve (56) and flow restrictor (53) is a drainage trap (57) in which debris is receivable without restricting the operativeness of valve (56). After fibrosis has occurred to prevent excessive drainage that might cause hypotony, flow restrictor (53) is removed to allow the free flow of fluid away from the eye, with inflammatory debris being prevented from reentering the eye.
Between valve (56) and flow restrictor (53) is a drainage trap (57) in which debris is receivable without restricting the operativeness of valve (56). After fibrosis has occurred to prevent excessive drainage that might cause hypotony, flow restrictor (53) is removed to allow the free flow of fluid away from the eye, with inflammatory debris being prevented from reentering the eye.
Description
o ~115263 WO 93/03778 . 1 PCI/US92/06859 Eye Filtration Prosthesis for Relievino Intr~ocul~r l'r~sl~r BACKGROUND OF THE INVENTION
Field of the Invention: The field of this inventlon is 5 eye surge~y. More specifically, this invention relates to surgical techniques for fistulization of the eye and to devices useful in such procedures.
Description of the Prior Art: It is well known in the field of Ophthalmology that chronic inflammation within an 10 eye can cause deterioration and gradual opacification of the cornea by slowly damaging the cells on the inside surface of the cornea. Chronic inflammation within the eye has also been shown to cause problems with the retina. It is particularly important to avoid chronic inflammation in 15 connection with ylaucoma surgery, which is performed when a patient develops difficulties from increased pressure within the eye. This increased pressure can cause damage to the optic nerve, which may be manifested by a loss of vision, or may cause changes in the visual field. Most cases of ~ 20 glaucoma are treatable by topical or oral medications, : however in many cases the patient must undergo glaucoma surgery to relieve the pressure. A glaucoma surgical procedure typically utilizes some type of fistulization process to drain fluids out from within the eye. With some 25 individuals, however., there is difficulty in maintaining ~: adeq~uate fistul~ization,?in which case mechanical devices are often implanted in.the eye to facilitate the outflow of fluid.
... . .. . .. . .
: These mechanical devices fall into two categories: frée flowing systems and pumps. Free flowing systems allow fluid 30 to filter out of the eye, with the flow of fluid being restricted only.by the size of the conduit and the '' ' - . .
.
WOg3/03778 ~ PCT/US92/~5 development of scar tissue which forms around the filtering system. Pumping mechanisms operate to mechanically assist in the flow of fluid away from the eye.
When the eye is being drained of fluids, care must`be 5 taken to avoid hypotony, which is a condition where the internal pressure within the eye becomes lower than desired.
A prolonged hypotony ~an lead to complications, such as shallowing or loss of the anterior chamber which can cause damage to the cornea. A hypotonic condition can also cause 10 hemorrhaging in the posterior portion of the eye, which may result în a choroidal or retinal detachment, and also could possibly result in the loss of the eye itself. To prevent hypotony with a free flowing drainage system, sometimes sutures are placed around portions of the filtration tube to 15 restrict the flow of fluid while scar tissue is developing.
Once scarring has been formed around the filtering system, a sufficient natural restriction on drainage has been created to allow the suture to be removed and drainage to take place.
One significant disadvantage of the free flowing systems .
is that a large amount of inflàmmatory debris can sometimes pass in a retrograde fashion from the filtration system and - filtering blebs back into the eye. While retrograde flow of inflammatory debris can o~cur at any time with such a system, ~ 25 this problem can be aggravated when the filtering tube is -~ closed, as described abovè, to prevent hypotony. When ~ ligàtures are used to constrict the filtering tu~e, blood and -~ debris fill the tube prosimal to the ligaturé and, upon opening the filtration tube, a large amount of inflammatory 30 debris is~liberated within the eye despite the fact that initial fluid flow from the eye to the filtering system pushes the debris temporarily back up into the filtration system. This back flow of inflammatory debris into the eye is a potential cause of chronic inflammation of the eye, ,-:
:
~ wo g3/03778 ~ ~ ~ 1 1 5 2 6 3 PCT/US92/06859 ; -3-possibly resulting in the above described urldesirable complications.
An example of a pump system for relieving intraocular pressure is shown in U.S. Patent No. 4,554,918 to White. ln 5 order to avoid hypotony, an inherent pressure gradient is needed to be achieved across the White pump b~fore fluid can flow through the pumping mechanism. It is suggested in U.S.
Patent No. 4,554,918 that this pressure gradient be in the ii range of 8-10 mm Hg. While this design characteristic of the 3~ 10 White pump helps decrease the occurrence of hypotony immediately after implantation, sometimes the eye does not reach a sufficient pressure for fluid to exit, in which case this pump fails to function as a pressure relief mechanism.
This pump also serves to restrict the retrograde flow of ~i 15 fluid, however debris has been found to clog the pumping ~l~ mechanism, causing it to fail to function properly. U. S.
~ Patent 4,886,488 to White discloses a second pressure relief $i~ system which also operates upon the occurrence of a pressure gradient in the range of 8-10 mm Hg.
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SUMMARY OF THE INV~NTION
This invention relates to improvements for relieving intraocular pressure within the eye with a reduced risk of inflammation within the eye that may be caused by the 5 retrograde flow of fluid and inflammatory debris back into the eye after a glaucoma surgical procedure has been performed. In the following description of the preferred embodimen~, a techni~ue is taught in which a unidirectional drainage device is implanted to drain fluids away from the 10 eye. The device operates to allow fluid to flow away from the eye with a minimal pressure gradient (5 mm Hg. or less), and includes means to prevent retrograde flow. In one embodiment, at the time of implantation the drainage :: .passageway is initially restricted or closed by a flow: lS restrictor at a point downstream from the minimal pressure gradient unidirectional valve. ~etween the unidirectional valve and flow restrictor is a drainage trap in which debris is rece~ivable without restricting the operativeness of the unidirectional valve. After sufficient scarring and fibrosis 20 has occurred to prevent e~cessive drainage that might cause hypotony, the flow restrictor is removed to allow the free flow of fluid away from the eye, with inflammatory debris being~-prevented from reentering the eye by being either drained away or by being maintained within the drainage 25 trap.
In a~second described embodiment~ the flow restrictor is located at:the distal end of the receptor tube of the device . within the eye, and acts to prevent the influx of fluids into the device from the eye during the initial period after 30 implantàtion. Upon removal of the flow restrictor, the free - flow of fluids away from the eye is allowed whi~le retrograde flow back into the eye is prevented by the action of a unidirectional valve which is designed to permit the forward O wo g3/03778 ~ ~ 1 5 2 6 3 PCT/US92/ ~ 59 flow of fluid there through under low pressure gradient conditions.
It is an object of the present invention to provide an improved technique for relieving intraocular pressure~which 5 also reduces the risk of inflammation within the eye after glaucoma surgery by either preventing or minimizing the flow of fluid and in1ammatory debris back into the eye.
It is a further object of the present invention to provide a new device which is useful for relieving 10 intraocular pressure while also serving to reduce the risk of inflammation within the eye after glaucoma surgery has been performed.
These and other objects and advantages will be apparent from a reading of the following specification.
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. WO93/03778 ~; ~` t `~ 63 PCl-/US92/0685 BRIEF DESCRIPTION OF THE DRAWINGS
FIG. la shows an eye filtration prosthesis 50 implanted on an eye in position to relieve excessive intraocular pressure by draining fluid away from the eye. ln FIG. 1~, s drainage is restricted by flow restrictor 53. FIG. lb shows a side elevational view of the implanted prosthesis of FIG.
la in relation to the eye on which it has been implanted, with a portion of the eye being shown in cut away fashion to show the portion of prosthesis 50 extending within -the eye.
FIG. 2a shows the implanted eye filtration prosthesis 50 of FIG. la after scarring has developed around drainage pla~e 54. In FIG. 2a, flow restrictor 53 has been removed to allow the free flow of fluids away from the eye. FIG. 2b is a side elevational view of the prosthesis shown in ~IG. 2a, with a 15 portion of the eye being shown in cut away fashion to show the portion of prosthesis 50 extending within the eye.
FIGS. 3a and 3b are fragmentary cross-sectional views of a portion of prosthesis 50 which includes unidirectional valve 56, trap 57, and flow restrictor 53, and illustrate the ; 20 operation of unidirectional flow away from the eye. In FIG.
3a, prosthesis 50 is closed by 10w restrictor 53 to restrict the flow of fluid away from the eye while scar tissue is in the process of forming around the implanted device. In FIG.
3b, pro~sthesis 50 has been opened by removing flow restrictor 25 53 to al10w~the-unrestricted flow of fluid away from the eye after~scar-tissue has been adequately formed to prevent ~ e~cèss;ive drainage that might cause hypotony.
`~ FIGS. 4à-~and 4b show a second eye filtration prosthesis 50' implanted on an eye in position to relieve e~cessive 30 intraocular pressure by draining fluid away from the eye. In ` FIG. 4a, drainage is restricted by flow restrictor 53' which ' ~
is located at the distal end of a receptor tube 51' within the eye. FIG. 4b shows a side elevational view of the implanted prosthesis of FIG. 4a in relation to the eye on .;~ ~
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~-~ W093/03778 ' 2 ~ 1 ~ 2 6 3 PCT/USg2/~Sg which it has been implanted, with a portion of eye 10 cut away to expose the location of flow restrictor 5~' at the distal end of a receptor tube 51' within the eye.
FIGS. 5a and 5b show an alternative valve configuration for inclusion with prosthesis 50'. In FIG. 5a, valve 56' is closed, preventing the backflow of fluid into the eye under negative pressure gradient conditions. In FIG. 5b, a positive pressure gradient has opened valve 56' thereby allowing the unrestricted flow of fluid away from the eye.
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~ DESCRIPTION OF THE PREFERRED EMBODIMENT
,;
For the purposes of prom~ting an understandirlg of t~l~
h principles of the invention, reference will now be mad~ to the embodiment illustrated in the drawings and specific 1 5 languase will be used to describe the same. It will r' nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and ~ further modifications in the illustrated device, and such a further applications of the principles of the invention as 10 illustrated therein being contemplated as would normally occur to one skilled in the art to WhiCIl the invention relates.
Referring now to the drawings, FIG. la shows an eye filtration prosthesis 50 implanted on an eye in position to 15 relieve e~cessive intraocular pressure by draining fluid away from eye lO. In FIG. la, prosthesis 50 is seen to include receptor tube 51, connector tube 52, flow restrictor 53, and drainage plate 54. FIG. lb shows a side elevational view of ~ ~ implanted prosthesis 50 in relation to eye lO on which it has `;~ 20 been implanted. In FIG lb, the end portion of receptor tube --~; 51 is seen to extend into the anterior chamber of eye lO, ~- where fluids are to be received into prosthesis 50 to relieve intraocular pressure within eye lO. Receptor tube 5l may also be positioned within the posterior chamber of the eye in 25 conjunction with a pars plana vitrectomy. Also shown in FIG.
lb are drainage ports 54a, located about the circumfèrence of drainage plate 54, at wllich location drained fluids are to exit prosthesis 50.
In FIGS. la and lb,~ drainage away from eye lO is 30 restricted by flow restrictor S3, which restricts or totally : .
; closeæ connector tube 52 to prevent the free flow of f luid.
Prosthesis 50 is initially left in this flow restricted condition at the time of implantation to prevent hypotony while scar tissue is formed around prosthesis 50. As ~:~
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Og3/03778 ;' ~; 2 1 1 S 2 6 3 PCT/US92/~859 mentioned, flow restrictor 53 may serve to either restrict, or totally close off, the flow of fluid through prosthesis 50 durin~ this time. If formed to restrict, but not totally close off the flow of fluid, then restrictor 53 may operate 5 to allow a minimal flow under high pressure gradient conditions (20 mm Hg or more). This restricted interim flow over a high pressure gradient does not create a risk of hypotony during the initial period after implantation, and advantageously provides for the partial alleviation of 10 excessive pressure during the formation of fibrosis.
Alternatively, restrictor 53 may be placed to fully close off the flow of fluid within prosthesis 50, in which case no drainage occurs through prosthesis 50 until the required scarring is formed, and restrictor 53 is subsequently removed.
-~ 15 FIG. 2a shows the implanted eye filtration prosthesis 50 of FIG. la after scarring has developed around drainage plate 54. After sufficient scarring and fibrosis has occurred to prevent e~cessive drainage that might cause hypotony, flow restrictor 53 is removed to allow the free flow of fluid away 20 from eye lO. In FIG. 2a, flow restrictor 53 has been removed to al`low the free flow of fluids away from eye lO. FIG. 2b is a side elevational view of prosthesis 50 shown in FIG. 2a, with flow restrictor 53 having been removed to allow for drainage to occur.
Implanted and utilized as described above, prosthesis 50 is useful for relieving intraocular pressure within the eye while~avoiding the possibi~lity of~ creating hypotony within the eye that`~could potentially cause severe damage to the ; -~eye. ~ Furthermore, prosthesis 50 is operable to assist in ~partially relieving ihtraocular pressure over high pressure gradients (20 mm H~ or more) immediately after implantation, and relieves intraocular pressure at low pressure gradients (less than 5 mm Hg) after fibrosis has been formed and flow restrictor 53 has been removed. This is accomplished by means of a low pressure gradient unidirectional valve 56 -. .
:
W093/03778 ~ 1 1 a263 PCT/USg2/0685~ ) described below in relation to FIGS. 3a and 3b. Prosthesis 50 also serves to reduce the risk of inflammation within the eye after glaucoma surgery has been performed by preventing the back flow of fluids into the eye which might cause such 5 inflammation to develop.
The operation of prosthesis 50 to provide for relief of intraocular pressure under low pressure gradient conditions and the prevention of retrograde flow into the eye will now be discussed in relation to FIGS. 3a and 3b. FIGS. 3a ancl 3b 10 are fragmentary cross-sectional views of the portion of prosthesis 50 which includes unidirectional valve 56, trap 57, and flow restrictor 53. Unidirectional valve 56, trap 57, and flow restrictor 53 operate, in conjunction, to permit unidirectional flow away from the eye and prevent the 15 retrograde flow of fluids and debris back into the eye which could cause the development of inflammation in the eye to occur.
In FIG. 3a, prosthesis 50 is closed by flow restrictor 53 to restrict the flow of fluid away from the eye while scar 20 tissue is in the process of forming around the implanted device. As discussed above, flow restrictor 53 may be configured to allow for the minimal flow of fluid under high pressure gradient conditions, or alternatively, to totally close off the flow of fluid through prosthesis 50. When 25 prosthesis 50 is in this flow restricting condition, inflammatory debris-~is allowed to pass through unidirectional valve 56 and into trap 57. The area of trap 57 between unidirectional valve S6 and flow restrictor 53 should be sized to adequately accommodate collected debris during the 30 period of closure without unduly restricting the operation of valve S6. ~ ~
Unidirectional valve S6 is designed to allow the free flow of fluid away from the eye under low pressure gradient conditions. ldeally, unidirectional valve S6 would operate in a near zero pressure gradient environment, although, in :
~ W093/03778 ~ 1 1 5 2 63 PCT/USg2/~59 reality, it is believed that unidirectiona1 valve 56 should open with the develo~ment of a positive pressure gradient of 5 mm Hg or less. Valve 56 is formed in a ~wet straw"
configuration where a generally circular cross-section is drawn to a flatten end. With this configuration, a positive pressure gradient serves to open the "wet straw" to allow fluid to flow, whereas a negative pressure gradient will cause valve 56 to collapse on i-tself to prevent retrograde flow. Because of its pliability and its low frictional 10 properties, TEFLON (polytetrafluoroethylene) is a suitable material for the construction of valve 56, although other ~ materials may be found to function satisfactorily. Also, it ; is to be noted that other specific valve configurations which provide for unidirectional flow under low pressure gradient . 15 conditions may be suitably incorporated into the present invention, as contemplated by the inventor.
~- In FIG. 3b, prosthesis 50 has been opened by the removal of flow restrictor 53 to allow the unrestricted flow of fluid . away from eye 10 after scar tissue has been adeguately formed . 20 to prevent excessive drainage that might cause hypotony.
Flow restrictor.53 is formed às a ring or loop type closure :
about the circumference of connector tube 52, which is suitably made of silicone material. Flow restrictor 53 may be made of any appropriate plastic or suture material that : 25 would.serve to cause a restriction in connector tube 52.
: Flow.restrictor 53 can be :removed by simply.cutting.it~away to.allow~tube-52 to return to its original configuration, as shown in FIG. 3b. In FIG. 3b,.it is seen that the positive pressure gradient causes valve 56 to open to a generally 30 circular configuration.to allow fluids to drain away ~rom eye ~ 10. Inflammatory debris which has ~ollected i.n trap 57 is -~` flushed away, or.may remain within connector tube 52, -: ~ however, such debris is prevented from reentering eye 10 owing to the unidirectional action of valve 56.
FIGS. ga and 4b show a second eye filtration prosthesis wo g3/03778 ~ 1 i 5 2 ~ 3 PCT/US92/~5~
50' implanted on an eye in position to relieve excessive intraocular pressure by draining fluid away from the eye.
Except as specifically described, the structure and operation of prosthesis 50' is the same as prosthesis 50, with prilned 5 numbered elements corresponding to same relative unprimed numbered elements of prosthesis S0. In FIG. 4a, drainage is restricted by flow restrictor 53' which i5 located at the distal end of a receptor tube 51' within the eye. FIG. 4b shows a side elevational view of the implanted prosthesis of lO FIG. 4a in relation to the eye on which it has been implanted, with a portion of eye 10 cut away to expose the . location of flow restrictor 53' at the distal end of a receptor tube 51' within the eye 10. Flow restrictor 53', by being located at the distal end of the receptor tube of the 15 device within the eye, acts to prevent the influx of fluids into the device from the eye during the initial period after implantation. Flow restrictor 53' may be removed from its restricting position on receptor tube 51 within eye 10 by the application of a laser beam of short duration on flow 20 restrictor 53'. Upon removal of flow restrictor 53', the free flow of fluids away from the eye is allowed while retrograde flow back into the eye is prevented in the same manner as described in relation to prosthesis 50.
FIGS. Sa and Sb show an alternative valve configuration 2s for~inclusion with prosthesis 50'. In FIG. Sa, valve 56' is forme:d~as-a flap and is shown in a closed position preventing the backflow of fluid into the eye under negative pressure gradient conditions. Wedge 58' provides reinforcement to flap valve 56' to aid in preventing a negative pressure 30 gradient from pushing valve 56' open backwardly. In FIG. Sb, a positive pressure gradient is shown to have opened valve 56' to allow the unrestricted flow of fluid away from the eye.-While the invention has been illustrated and described in 3s detail in the drawings and foregoing description, the same is ~y~s ~
~ ~ wo g3/03778 ` 2 1 1 ~ ~ 6 3 PCT/US92/06859 to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes and modifications that come within the spirit of the 5 invention are desir~d to be protected.
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Field of the Invention: The field of this inventlon is 5 eye surge~y. More specifically, this invention relates to surgical techniques for fistulization of the eye and to devices useful in such procedures.
Description of the Prior Art: It is well known in the field of Ophthalmology that chronic inflammation within an 10 eye can cause deterioration and gradual opacification of the cornea by slowly damaging the cells on the inside surface of the cornea. Chronic inflammation within the eye has also been shown to cause problems with the retina. It is particularly important to avoid chronic inflammation in 15 connection with ylaucoma surgery, which is performed when a patient develops difficulties from increased pressure within the eye. This increased pressure can cause damage to the optic nerve, which may be manifested by a loss of vision, or may cause changes in the visual field. Most cases of ~ 20 glaucoma are treatable by topical or oral medications, : however in many cases the patient must undergo glaucoma surgery to relieve the pressure. A glaucoma surgical procedure typically utilizes some type of fistulization process to drain fluids out from within the eye. With some 25 individuals, however., there is difficulty in maintaining ~: adeq~uate fistul~ization,?in which case mechanical devices are often implanted in.the eye to facilitate the outflow of fluid.
... . .. . .. . .
: These mechanical devices fall into two categories: frée flowing systems and pumps. Free flowing systems allow fluid 30 to filter out of the eye, with the flow of fluid being restricted only.by the size of the conduit and the '' ' - . .
.
WOg3/03778 ~ PCT/US92/~5 development of scar tissue which forms around the filtering system. Pumping mechanisms operate to mechanically assist in the flow of fluid away from the eye.
When the eye is being drained of fluids, care must`be 5 taken to avoid hypotony, which is a condition where the internal pressure within the eye becomes lower than desired.
A prolonged hypotony ~an lead to complications, such as shallowing or loss of the anterior chamber which can cause damage to the cornea. A hypotonic condition can also cause 10 hemorrhaging in the posterior portion of the eye, which may result în a choroidal or retinal detachment, and also could possibly result in the loss of the eye itself. To prevent hypotony with a free flowing drainage system, sometimes sutures are placed around portions of the filtration tube to 15 restrict the flow of fluid while scar tissue is developing.
Once scarring has been formed around the filtering system, a sufficient natural restriction on drainage has been created to allow the suture to be removed and drainage to take place.
One significant disadvantage of the free flowing systems .
is that a large amount of inflàmmatory debris can sometimes pass in a retrograde fashion from the filtration system and - filtering blebs back into the eye. While retrograde flow of inflammatory debris can o~cur at any time with such a system, ~ 25 this problem can be aggravated when the filtering tube is -~ closed, as described abovè, to prevent hypotony. When ~ ligàtures are used to constrict the filtering tu~e, blood and -~ debris fill the tube prosimal to the ligaturé and, upon opening the filtration tube, a large amount of inflammatory 30 debris is~liberated within the eye despite the fact that initial fluid flow from the eye to the filtering system pushes the debris temporarily back up into the filtration system. This back flow of inflammatory debris into the eye is a potential cause of chronic inflammation of the eye, ,-:
:
~ wo g3/03778 ~ ~ ~ 1 1 5 2 6 3 PCT/US92/06859 ; -3-possibly resulting in the above described urldesirable complications.
An example of a pump system for relieving intraocular pressure is shown in U.S. Patent No. 4,554,918 to White. ln 5 order to avoid hypotony, an inherent pressure gradient is needed to be achieved across the White pump b~fore fluid can flow through the pumping mechanism. It is suggested in U.S.
Patent No. 4,554,918 that this pressure gradient be in the ii range of 8-10 mm Hg. While this design characteristic of the 3~ 10 White pump helps decrease the occurrence of hypotony immediately after implantation, sometimes the eye does not reach a sufficient pressure for fluid to exit, in which case this pump fails to function as a pressure relief mechanism.
This pump also serves to restrict the retrograde flow of ~i 15 fluid, however debris has been found to clog the pumping ~l~ mechanism, causing it to fail to function properly. U. S.
~ Patent 4,886,488 to White discloses a second pressure relief $i~ system which also operates upon the occurrence of a pressure gradient in the range of 8-10 mm Hg.
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, . W093/03778 . ... ..: 2~ 63 PCT/USg2/~5~
SUMMARY OF THE INV~NTION
This invention relates to improvements for relieving intraocular pressure within the eye with a reduced risk of inflammation within the eye that may be caused by the 5 retrograde flow of fluid and inflammatory debris back into the eye after a glaucoma surgical procedure has been performed. In the following description of the preferred embodimen~, a techni~ue is taught in which a unidirectional drainage device is implanted to drain fluids away from the 10 eye. The device operates to allow fluid to flow away from the eye with a minimal pressure gradient (5 mm Hg. or less), and includes means to prevent retrograde flow. In one embodiment, at the time of implantation the drainage :: .passageway is initially restricted or closed by a flow: lS restrictor at a point downstream from the minimal pressure gradient unidirectional valve. ~etween the unidirectional valve and flow restrictor is a drainage trap in which debris is rece~ivable without restricting the operativeness of the unidirectional valve. After sufficient scarring and fibrosis 20 has occurred to prevent e~cessive drainage that might cause hypotony, the flow restrictor is removed to allow the free flow of fluid away from the eye, with inflammatory debris being~-prevented from reentering the eye by being either drained away or by being maintained within the drainage 25 trap.
In a~second described embodiment~ the flow restrictor is located at:the distal end of the receptor tube of the device . within the eye, and acts to prevent the influx of fluids into the device from the eye during the initial period after 30 implantàtion. Upon removal of the flow restrictor, the free - flow of fluids away from the eye is allowed whi~le retrograde flow back into the eye is prevented by the action of a unidirectional valve which is designed to permit the forward O wo g3/03778 ~ ~ 1 5 2 6 3 PCT/US92/ ~ 59 flow of fluid there through under low pressure gradient conditions.
It is an object of the present invention to provide an improved technique for relieving intraocular pressure~which 5 also reduces the risk of inflammation within the eye after glaucoma surgery by either preventing or minimizing the flow of fluid and in1ammatory debris back into the eye.
It is a further object of the present invention to provide a new device which is useful for relieving 10 intraocular pressure while also serving to reduce the risk of inflammation within the eye after glaucoma surgery has been performed.
These and other objects and advantages will be apparent from a reading of the following specification.
.
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. WO93/03778 ~; ~` t `~ 63 PCl-/US92/0685 BRIEF DESCRIPTION OF THE DRAWINGS
FIG. la shows an eye filtration prosthesis 50 implanted on an eye in position to relieve excessive intraocular pressure by draining fluid away from the eye. ln FIG. 1~, s drainage is restricted by flow restrictor 53. FIG. lb shows a side elevational view of the implanted prosthesis of FIG.
la in relation to the eye on which it has been implanted, with a portion of the eye being shown in cut away fashion to show the portion of prosthesis 50 extending within -the eye.
FIG. 2a shows the implanted eye filtration prosthesis 50 of FIG. la after scarring has developed around drainage pla~e 54. In FIG. 2a, flow restrictor 53 has been removed to allow the free flow of fluids away from the eye. FIG. 2b is a side elevational view of the prosthesis shown in ~IG. 2a, with a 15 portion of the eye being shown in cut away fashion to show the portion of prosthesis 50 extending within the eye.
FIGS. 3a and 3b are fragmentary cross-sectional views of a portion of prosthesis 50 which includes unidirectional valve 56, trap 57, and flow restrictor 53, and illustrate the ; 20 operation of unidirectional flow away from the eye. In FIG.
3a, prosthesis 50 is closed by 10w restrictor 53 to restrict the flow of fluid away from the eye while scar tissue is in the process of forming around the implanted device. In FIG.
3b, pro~sthesis 50 has been opened by removing flow restrictor 25 53 to al10w~the-unrestricted flow of fluid away from the eye after~scar-tissue has been adequately formed to prevent ~ e~cèss;ive drainage that might cause hypotony.
`~ FIGS. 4à-~and 4b show a second eye filtration prosthesis 50' implanted on an eye in position to relieve e~cessive 30 intraocular pressure by draining fluid away from the eye. In ` FIG. 4a, drainage is restricted by flow restrictor 53' which ' ~
is located at the distal end of a receptor tube 51' within the eye. FIG. 4b shows a side elevational view of the implanted prosthesis of FIG. 4a in relation to the eye on .;~ ~
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~-~ W093/03778 ' 2 ~ 1 ~ 2 6 3 PCT/USg2/~Sg which it has been implanted, with a portion of eye 10 cut away to expose the location of flow restrictor 5~' at the distal end of a receptor tube 51' within the eye.
FIGS. 5a and 5b show an alternative valve configuration for inclusion with prosthesis 50'. In FIG. 5a, valve 56' is closed, preventing the backflow of fluid into the eye under negative pressure gradient conditions. In FIG. 5b, a positive pressure gradient has opened valve 56' thereby allowing the unrestricted flow of fluid away from the eye.
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~ DESCRIPTION OF THE PREFERRED EMBODIMENT
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For the purposes of prom~ting an understandirlg of t~l~
h principles of the invention, reference will now be mad~ to the embodiment illustrated in the drawings and specific 1 5 languase will be used to describe the same. It will r' nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and ~ further modifications in the illustrated device, and such a further applications of the principles of the invention as 10 illustrated therein being contemplated as would normally occur to one skilled in the art to WhiCIl the invention relates.
Referring now to the drawings, FIG. la shows an eye filtration prosthesis 50 implanted on an eye in position to 15 relieve e~cessive intraocular pressure by draining fluid away from eye lO. In FIG. la, prosthesis 50 is seen to include receptor tube 51, connector tube 52, flow restrictor 53, and drainage plate 54. FIG. lb shows a side elevational view of ~ ~ implanted prosthesis 50 in relation to eye lO on which it has `;~ 20 been implanted. In FIG lb, the end portion of receptor tube --~; 51 is seen to extend into the anterior chamber of eye lO, ~- where fluids are to be received into prosthesis 50 to relieve intraocular pressure within eye lO. Receptor tube 5l may also be positioned within the posterior chamber of the eye in 25 conjunction with a pars plana vitrectomy. Also shown in FIG.
lb are drainage ports 54a, located about the circumfèrence of drainage plate 54, at wllich location drained fluids are to exit prosthesis 50.
In FIGS. la and lb,~ drainage away from eye lO is 30 restricted by flow restrictor S3, which restricts or totally : .
; closeæ connector tube 52 to prevent the free flow of f luid.
Prosthesis 50 is initially left in this flow restricted condition at the time of implantation to prevent hypotony while scar tissue is formed around prosthesis 50. As ~:~
'' ~ .
Og3/03778 ;' ~; 2 1 1 S 2 6 3 PCT/US92/~859 mentioned, flow restrictor 53 may serve to either restrict, or totally close off, the flow of fluid through prosthesis 50 durin~ this time. If formed to restrict, but not totally close off the flow of fluid, then restrictor 53 may operate 5 to allow a minimal flow under high pressure gradient conditions (20 mm Hg or more). This restricted interim flow over a high pressure gradient does not create a risk of hypotony during the initial period after implantation, and advantageously provides for the partial alleviation of 10 excessive pressure during the formation of fibrosis.
Alternatively, restrictor 53 may be placed to fully close off the flow of fluid within prosthesis 50, in which case no drainage occurs through prosthesis 50 until the required scarring is formed, and restrictor 53 is subsequently removed.
-~ 15 FIG. 2a shows the implanted eye filtration prosthesis 50 of FIG. la after scarring has developed around drainage plate 54. After sufficient scarring and fibrosis has occurred to prevent e~cessive drainage that might cause hypotony, flow restrictor 53 is removed to allow the free flow of fluid away 20 from eye lO. In FIG. 2a, flow restrictor 53 has been removed to al`low the free flow of fluids away from eye lO. FIG. 2b is a side elevational view of prosthesis 50 shown in FIG. 2a, with flow restrictor 53 having been removed to allow for drainage to occur.
Implanted and utilized as described above, prosthesis 50 is useful for relieving intraocular pressure within the eye while~avoiding the possibi~lity of~ creating hypotony within the eye that`~could potentially cause severe damage to the ; -~eye. ~ Furthermore, prosthesis 50 is operable to assist in ~partially relieving ihtraocular pressure over high pressure gradients (20 mm H~ or more) immediately after implantation, and relieves intraocular pressure at low pressure gradients (less than 5 mm Hg) after fibrosis has been formed and flow restrictor 53 has been removed. This is accomplished by means of a low pressure gradient unidirectional valve 56 -. .
:
W093/03778 ~ 1 1 a263 PCT/USg2/0685~ ) described below in relation to FIGS. 3a and 3b. Prosthesis 50 also serves to reduce the risk of inflammation within the eye after glaucoma surgery has been performed by preventing the back flow of fluids into the eye which might cause such 5 inflammation to develop.
The operation of prosthesis 50 to provide for relief of intraocular pressure under low pressure gradient conditions and the prevention of retrograde flow into the eye will now be discussed in relation to FIGS. 3a and 3b. FIGS. 3a ancl 3b 10 are fragmentary cross-sectional views of the portion of prosthesis 50 which includes unidirectional valve 56, trap 57, and flow restrictor 53. Unidirectional valve 56, trap 57, and flow restrictor 53 operate, in conjunction, to permit unidirectional flow away from the eye and prevent the 15 retrograde flow of fluids and debris back into the eye which could cause the development of inflammation in the eye to occur.
In FIG. 3a, prosthesis 50 is closed by flow restrictor 53 to restrict the flow of fluid away from the eye while scar 20 tissue is in the process of forming around the implanted device. As discussed above, flow restrictor 53 may be configured to allow for the minimal flow of fluid under high pressure gradient conditions, or alternatively, to totally close off the flow of fluid through prosthesis 50. When 25 prosthesis 50 is in this flow restricting condition, inflammatory debris-~is allowed to pass through unidirectional valve 56 and into trap 57. The area of trap 57 between unidirectional valve S6 and flow restrictor 53 should be sized to adequately accommodate collected debris during the 30 period of closure without unduly restricting the operation of valve S6. ~ ~
Unidirectional valve S6 is designed to allow the free flow of fluid away from the eye under low pressure gradient conditions. ldeally, unidirectional valve S6 would operate in a near zero pressure gradient environment, although, in :
~ W093/03778 ~ 1 1 5 2 63 PCT/USg2/~59 reality, it is believed that unidirectiona1 valve 56 should open with the develo~ment of a positive pressure gradient of 5 mm Hg or less. Valve 56 is formed in a ~wet straw"
configuration where a generally circular cross-section is drawn to a flatten end. With this configuration, a positive pressure gradient serves to open the "wet straw" to allow fluid to flow, whereas a negative pressure gradient will cause valve 56 to collapse on i-tself to prevent retrograde flow. Because of its pliability and its low frictional 10 properties, TEFLON (polytetrafluoroethylene) is a suitable material for the construction of valve 56, although other ~ materials may be found to function satisfactorily. Also, it ; is to be noted that other specific valve configurations which provide for unidirectional flow under low pressure gradient . 15 conditions may be suitably incorporated into the present invention, as contemplated by the inventor.
~- In FIG. 3b, prosthesis 50 has been opened by the removal of flow restrictor 53 to allow the unrestricted flow of fluid . away from eye 10 after scar tissue has been adeguately formed . 20 to prevent excessive drainage that might cause hypotony.
Flow restrictor.53 is formed às a ring or loop type closure :
about the circumference of connector tube 52, which is suitably made of silicone material. Flow restrictor 53 may be made of any appropriate plastic or suture material that : 25 would.serve to cause a restriction in connector tube 52.
: Flow.restrictor 53 can be :removed by simply.cutting.it~away to.allow~tube-52 to return to its original configuration, as shown in FIG. 3b. In FIG. 3b,.it is seen that the positive pressure gradient causes valve 56 to open to a generally 30 circular configuration.to allow fluids to drain away ~rom eye ~ 10. Inflammatory debris which has ~ollected i.n trap 57 is -~` flushed away, or.may remain within connector tube 52, -: ~ however, such debris is prevented from reentering eye 10 owing to the unidirectional action of valve 56.
FIGS. ga and 4b show a second eye filtration prosthesis wo g3/03778 ~ 1 i 5 2 ~ 3 PCT/US92/~5~
50' implanted on an eye in position to relieve excessive intraocular pressure by draining fluid away from the eye.
Except as specifically described, the structure and operation of prosthesis 50' is the same as prosthesis 50, with prilned 5 numbered elements corresponding to same relative unprimed numbered elements of prosthesis S0. In FIG. 4a, drainage is restricted by flow restrictor 53' which i5 located at the distal end of a receptor tube 51' within the eye. FIG. 4b shows a side elevational view of the implanted prosthesis of lO FIG. 4a in relation to the eye on which it has been implanted, with a portion of eye 10 cut away to expose the . location of flow restrictor 53' at the distal end of a receptor tube 51' within the eye 10. Flow restrictor 53', by being located at the distal end of the receptor tube of the 15 device within the eye, acts to prevent the influx of fluids into the device from the eye during the initial period after implantation. Flow restrictor 53' may be removed from its restricting position on receptor tube 51 within eye 10 by the application of a laser beam of short duration on flow 20 restrictor 53'. Upon removal of flow restrictor 53', the free flow of fluids away from the eye is allowed while retrograde flow back into the eye is prevented in the same manner as described in relation to prosthesis 50.
FIGS. Sa and Sb show an alternative valve configuration 2s for~inclusion with prosthesis 50'. In FIG. Sa, valve 56' is forme:d~as-a flap and is shown in a closed position preventing the backflow of fluid into the eye under negative pressure gradient conditions. Wedge 58' provides reinforcement to flap valve 56' to aid in preventing a negative pressure 30 gradient from pushing valve 56' open backwardly. In FIG. Sb, a positive pressure gradient is shown to have opened valve 56' to allow the unrestricted flow of fluid away from the eye.-While the invention has been illustrated and described in 3s detail in the drawings and foregoing description, the same is ~y~s ~
~ ~ wo g3/03778 ` 2 1 1 ~ ~ 6 3 PCT/US92/06859 to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes and modifications that come within the spirit of the 5 invention are desir~d to be protected.
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Claims (17)
1. An eye filtration prosthesis for relieving intraocular pressure from within the eye, said device comprising:
conduit means for receiving fluid from within the interior of the eye and draining the received fluid away from the eye;
drainage port means for draining fluid received by said conduit means out of said prosthesis at a location exterior of the eye;
a low pressure gradient unidirectional valve within said conduit means, said valve including means for allowing fluid to pass away from the eye under low pressure gradient conditions and preventing retrograde flow back into the eye;
and flow restrictor means for restricting the flow of fluid away from the eye; and wherein said prosthesis, when implanted, is operable in a flow restricted state in which said flow restrictor restricts the flow of fluid within said conduit means away from the eye and out of said prosthesis; and a free flow state in which said flow restrictor means has been deactivated to allow fluid to freely flow there past, with said valve allowing fluid to flow though said conduit means under low pressure gradient conditions while preventing retrograde flow back into the eye.
conduit means for receiving fluid from within the interior of the eye and draining the received fluid away from the eye;
drainage port means for draining fluid received by said conduit means out of said prosthesis at a location exterior of the eye;
a low pressure gradient unidirectional valve within said conduit means, said valve including means for allowing fluid to pass away from the eye under low pressure gradient conditions and preventing retrograde flow back into the eye;
and flow restrictor means for restricting the flow of fluid away from the eye; and wherein said prosthesis, when implanted, is operable in a flow restricted state in which said flow restrictor restricts the flow of fluid within said conduit means away from the eye and out of said prosthesis; and a free flow state in which said flow restrictor means has been deactivated to allow fluid to freely flow there past, with said valve allowing fluid to flow though said conduit means under low pressure gradient conditions while preventing retrograde flow back into the eye.
2. The eye filtration prosthesis of claim 1 in which said flow restrictor means is located on said conduit means downstream from said valve and said conduit means defines a trap area for collecting fluid and debris between said valve and said flow restrictor means; and wherein said prosthesis, when in its flow restricted state, is operable to allow fluid and debris to pass through said valve and be collected within said trap area while said flow restrictor means restricts the further flow of fluid within said conduit means away from the eye and out of said prosthesis.
3. The eye filtration prosthesis of claim 1 in which said low pressure gradient unidirectional valve allows fluid to flow there through at a pressure gradient of less than about 5 mm Hg. across said valve.
4. The eye filtration prosthesis of claim 2 in which said low pressure gradient unidirectional valve allows fluid to flow there through at a pressure gradient of less than about 5 mm Hg. across said valve.
5. The eye filtration prosthesis of claim 1 in which said valve is formed in a "wet straw" configuration by which a generally circular configuration is formed to a flattened end, and whereby a positive pressure gradient causes said valve to open to allow fluid to flow away from the eye, and a negative pressure gradient causes said valve to collapse on itself to prevent retrograde flow.
6. The eye filtration prosthesis of claim 5 in which said valve is made of polytetrafluoroethylene.
7. The eye filtration prosthesis of claim 2 in which said flow restrictor means includes means for allowing the restricted flow of fluid there past upon the occurrence of a high pressure gradient condition across said flow restrictor means.
8. The eye filtration prosthesis of claim 2 in which said flow restrictor means includes means for allowing the restricted flow of fluid there past upon the occurrence of a pressure gradient condition across said flow restrictor means of more than about 20 mm Hg.
9. The eye filtration prosthesis of claim 7 in which said flow restrictor means includes means for allowing the restricted flow of fluid there past upon the occurrence of a pressure gradient condition across said flow restrictor means of more than about 20 mm Hg.
10. The eye filtration prosthesis of claim 1 in which said flow restrictor means includes means for totally closing the flow of fluid there past.
11. A method for relieving intraocular pressure from within the eye, said method comprising the steps of:
implanting an eye filtration prosthesis on the eye, said prosthesis including conduit means for receiving fluid from within the interior of the eye and draining the received fluid away from the eye; drainage port means for draining fluid received by said conduit means out of said prosthesis at a location exterior of the eye; a low pressure gradient unidirectional valve within said conduit means, said valve including means for allowing fluid to pass away from the eye under low pressure gradient conditions and preventing retrograde flow back into the eye; and flow restrictor means for restricting the flow of fluid away from the eye;
allowing said prosthesis to remain implanted in a flow restricted state, in which said flow restrictor restricts the flow of fluid within said conduit means away from the eye and out of said prosthesis, until fibrosis has formed about said drainage port means; and after fibrosis has formed, deactivating said flow restrictor means to allow fluid to freely flow there past, with said valve allowing fluid to flow though said conduit means under low pressure gradient conditions while preventing retrograde flow back into the eye.
implanting an eye filtration prosthesis on the eye, said prosthesis including conduit means for receiving fluid from within the interior of the eye and draining the received fluid away from the eye; drainage port means for draining fluid received by said conduit means out of said prosthesis at a location exterior of the eye; a low pressure gradient unidirectional valve within said conduit means, said valve including means for allowing fluid to pass away from the eye under low pressure gradient conditions and preventing retrograde flow back into the eye; and flow restrictor means for restricting the flow of fluid away from the eye;
allowing said prosthesis to remain implanted in a flow restricted state, in which said flow restrictor restricts the flow of fluid within said conduit means away from the eye and out of said prosthesis, until fibrosis has formed about said drainage port means; and after fibrosis has formed, deactivating said flow restrictor means to allow fluid to freely flow there past, with said valve allowing fluid to flow though said conduit means under low pressure gradient conditions while preventing retrograde flow back into the eye.
12. The method for relieving intraocular pressure of claim 11 in which said low pressure gradient unidirectional valve allows fluid to flow there through at a pressure gradients of less than about 5 mm Hg. across said valve.
13. The method for relieving intraocular pressure of claim 11 in which said flow restrictor means includes means for totally closing the flow of fluid there past.
14. A method for relieving intraocular pressure from within the eye, said method comprising the steps of:
implanting an eye filtration prosthesis on the eye, said prosthesis including conduit means for receiving fluid from within the interior of the eye and draining the received fluid away from the eye; drainage port means for draining fluid received by said conduit means out of said prosthesis at a location exterior of the eye; a low pressure gradient unidirectional valve within said conduit means, said valve including means for allowing fluid to pass away from the eye under low pressure gradient conditions and preventing retrograde flow back into the eye; and flow restrictor means for restricting the flow of fluid away from the eye, said flow restrictor means being located on said conduit means downstream from said valve; and in which said conduit means defines a trap area for collecting fluid and debris between said valve and said flow restrictor means;
allowing said prosthesis to remain implanted in a flow restricted state, in which fluid and debris may pass through said valve and be collected within said trap area while said flow restrictor restricts the further flow of fluid within said conduit means away from the eye and out of said prosthesis, until fibrosis has formed about said drainage port means; and after fibrosis has formed, deactivating said flow restrictor means to allow fluid to freely flow there past, with said valve allowing fluid to flow though said conduit means under low pressure gradient conditions while preventing retrograde flow back into the eye.
implanting an eye filtration prosthesis on the eye, said prosthesis including conduit means for receiving fluid from within the interior of the eye and draining the received fluid away from the eye; drainage port means for draining fluid received by said conduit means out of said prosthesis at a location exterior of the eye; a low pressure gradient unidirectional valve within said conduit means, said valve including means for allowing fluid to pass away from the eye under low pressure gradient conditions and preventing retrograde flow back into the eye; and flow restrictor means for restricting the flow of fluid away from the eye, said flow restrictor means being located on said conduit means downstream from said valve; and in which said conduit means defines a trap area for collecting fluid and debris between said valve and said flow restrictor means;
allowing said prosthesis to remain implanted in a flow restricted state, in which fluid and debris may pass through said valve and be collected within said trap area while said flow restrictor restricts the further flow of fluid within said conduit means away from the eye and out of said prosthesis, until fibrosis has formed about said drainage port means; and after fibrosis has formed, deactivating said flow restrictor means to allow fluid to freely flow there past, with said valve allowing fluid to flow though said conduit means under low pressure gradient conditions while preventing retrograde flow back into the eye.
15. The method for relieving intraocular pressure of claim 14 in which said low pressure gradient unidirectional valve allows fluid to flow there through at a pressure gradients of less than about 5 mm Hg. across said valve.
16. The method for relieving intraocular pressure of claim 14 in which said flow restrictor means includes means for allowing the restricted flow of fluid there past upon the occurrence of a high pressure gradient condition across said flow restrictor means.
17. The method for relieving intraocular pressure of claim 16 in which said flow restrictor means includes means for allowing the restricted flow of fluid there past upon the occurrence of a pressure gradient condition across said flow restrictor means of more than about 20 mm Hg.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US744,875 | 1991-08-14 | ||
US07/744,875 US5171213A (en) | 1991-08-14 | 1991-08-14 | Technique for fistulization of the eye and an eye filtration prosthesis useful therefor |
Publications (1)
Publication Number | Publication Date |
---|---|
CA2115263A1 true CA2115263A1 (en) | 1993-03-04 |
Family
ID=24994305
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002115263A Abandoned CA2115263A1 (en) | 1991-08-14 | 1992-08-14 | Eye filtration prosthesis for relieving intraocular pressure |
Country Status (7)
Country | Link |
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US (1) | US5171213A (en) |
EP (1) | EP0596045A4 (en) |
JP (1) | JPH06509732A (en) |
AU (1) | AU2513392A (en) |
CA (1) | CA2115263A1 (en) |
RU (1) | RU94016165A (en) |
WO (1) | WO1993003778A1 (en) |
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-
1991
- 1991-08-14 US US07/744,875 patent/US5171213A/en not_active Expired - Fee Related
-
1992
- 1992-08-14 WO PCT/US1992/006859 patent/WO1993003778A1/en not_active Application Discontinuation
- 1992-08-14 JP JP5504474A patent/JPH06509732A/en active Pending
- 1992-08-14 RU RU94016165/14A patent/RU94016165A/en unknown
- 1992-08-14 EP EP92918858A patent/EP0596045A4/en not_active Withdrawn
- 1992-08-14 CA CA002115263A patent/CA2115263A1/en not_active Abandoned
- 1992-08-14 AU AU25133/92A patent/AU2513392A/en not_active Abandoned
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AU2513392A (en) | 1993-03-16 |
WO1993003778A1 (en) | 1993-03-04 |
EP0596045A4 (en) | 1994-12-28 |
EP0596045A1 (en) | 1994-05-11 |
RU94016165A (en) | 1996-05-20 |
US5171213A (en) | 1992-12-15 |
JPH06509732A (en) | 1994-11-02 |
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Legal Events
Date | Code | Title | Description |
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FZDE | Discontinued |