CA1187369A

CA1187369A - Glaucoma treatment device

Info

Publication number: CA1187369A
Application number: CA000408236A
Authority: CA
Inventors: Antonio Mendez
Original assignee: Surgidev Corp
Current assignee: Advanced Vision Science Inc
Priority date: 1981-07-29
Filing date: 1982-07-28
Publication date: 1985-05-21
Also published as: US4428746A; EP0084054A1; WO1983000420A1; EP0084054A4

Abstract

ABSTRACT OF THE DISCLOSURE
Glaucoma treatment device for surgical implant for the treatment and management of glaucoma. The glaucoma treatment device includes a single continuous length of cylindrical member having two ends substantially in a first plane and angled slightly inwards toward each other, two smaller loops having the small loops substantially in a like second plane at a slight out-ward angle to the first plane and each outer end of the small loops connected to the two ends, and an elongated large loop with a large end radius in between the two ends, substantially positioned in the first plane and connected to the inner ends of the smaller loops. The cylindrical member can consist of poly-methylmethacrylate or like material. The device is surgically implanted in the eye under a partial thickness scleral flap in the newly formed scleral bed, and secures a channel for aqueous humor to flow away from the eye.

Description

~ D~

The present lnVentiOn relates to a surgically implantable opthalmo-logic treatment device and, more particular:Ly, pertains to a surgical implant treatment device For management and treatment oE glaucoma known as the Mendez Setoll g]aucoma treatment device.
'rhe prior art has providecl drugs, sllrgical procedures and devices for tlle management ancl treatment oE glaucoma.
One treatment oE glaucoma involves eye drops to the individual, daily or beiore retiring, which tends to decrease intraocu]ar pressure. However, in some cases intended benefits do not materialize or the medications become too :LO expensive.
Surgical procedures for treatment o~ glaucoma can include the trabe-culotomy, thermal sclerotomy, Schie (thermal sclerotonmy) method or the trabecul-ectomy, all of which are intended to relieve intraocular pressure.
Another more recent method for the control of glaucoma is referred to as the Storz Knlpin-Denver eye valve which is an open tu'oe extending 1 to ~
millimeters into the anterior chamber. A silicone tube attaches to the open tube at an angle where the sealed end of the silicone tube contains horizontal and vertical slits to control aqueous drainage to subscleral space. Two sidearms are sutured to the sclera providing stabili~y. The valve flow rate increases as the intraocular pressure increases. The particular probLem with this type of valvular device for controlling glaucoma within glaucomatous eyes is that the eye valve can become clogged, no longer passing Eluid and allowing the intraocular pressure (I.O.P.) to increase, resultlng :in the same preoper-ative condition. Also, the eye valve may require supportive medical therapy.
This type of eye valve is described in United States Patent No. ~,037,60~1.
The present in-vention overcomes the disadvantages of the prior art by providing a glaucoma treatment device for surgical implant which is a single ~1--continuous length cy]indrical member providing for a channel and pathway for aqueous humor -to leave the eye, thereby providing long-term management and trea-tment of glaucoma.
The present invention is utilized in a surgical opera-tion which is similar to types of surgical maneuvers familiar to the surgeon. The present invention includes the surgical implanta--tion of the glaucoma treatment device which o:Efers distinct benefits over other implantable devices or valves and provides for long-term management and treatment which is absent in the prior art.
SUMMARY OF THE INVENTION
. . ~
The general purpose of the present invention is to provide a glaucoma treatment device for surgical implant in the management and treatment of glaucoma, and which provides for long-term high reliability of treatment in a patient. The implantable device is surgically implanted into the anterior chamber of the eye under at least a partial scleral flap, thereby providing a channel for aqueous humor to flow away from the eye and thereby relieve pressure on the eye. The implant-able glaucoma treatment device provides for long-term -treatment.
According to one aspect of the present invention, there is provided a glaucoma treatment device for treating disease of glaucoma in -the human eye by surgical implant, said device comprising:
a. means including at least -two small geometrical loop means of a small diameter and a large slightly elongated loop in a plane with said two small loop means and connected to said ends ^ said smal] loops for position ng withi.n a portion of -the eye;

and, h. means including two substantially aligned parallel members eonnected to said loop means at an angle for positioning in at least a partial scleral flap of said eye, and connected at an angle to said loop means whereby said device provides a canal between said loop means and said member means thereby providing for discharge of aqueous humor from interior of said eye.
According -to another aspect of -the presen-t invention, there ean be provided a glaueoma treatment deviee for surgieal implant in an eye, said deviee comprising:
a. at least two small :Loop means on one plane providing a diseharge ehannel from an anterior chamber of said eye; and b. at least one large loop means connecting between said two small loop means and two member means eonnee-ted to outer ends of said small loop means providing ehannels for surfaeincJ within selera o:E said eye whereby said diseharge ehannel means and said ehannel surfaee member means provide for diseharqe o:E
aqueous humor from an anterior ehamber of said eye.
~ eeordi.ng to an additional aspeet oE the present invention, there is provicl~ a glaueoma treatment deviee eomprising:
a. eontirluous f.inlte lencJth oE a geometrl.eal member, said member ineludlnct a substanti.ally ident:ieal cJeomet.rieal eross seet:ion at ecleh i.ne.rement o.E said f.inite :Lenctth inelucling two encls in a :E:i.rst plane;
b. at. Lec;lsk two smal.L loop means in a second p:Lane at an ancJle to sai.cl :irst: p:l.ane and eaeh outer encl of sa:id :Loop means eonlleeled t..o salcl encls; ancl, e. at least one eloncJatecl lar~3e loop ineludincl a ma-jor radlus r~ ~/ T ~

in said first plane and connec-ted be-tween each of said small loop means whereby said small loop means are surgically implanted into an an-terior chamber of an eye and said large loop and ends are under a sclera]. flap or partial scleral flap of sai.d eye -thereby securing a channel for discharge of a(lueous humor to flow away from said eye for decrease of pressure.
BRIEF DESCRIPTION OF THF DRZ\T~INGS
Other objec-ts and many of -the attendant advan-tages of this invention will be readily appreciated as the same becomes better understood by reference ,~ --4 to the t`ol:Lowing cletailed description when considered in connection with the accompanylng drawings, in which Like reference numerals designate like parts throllghout the cigures thereof ancl wherein:
Figure l illustrates a glaucoma treatment clevice surgically implanted :in the eye;
F:igure 2 illustrates a perspective view of the glailcoma treatment clevice;
Figure 3 illustrates a boitom view of the glaucoma treatment device;
Figure 4 illustrates a side view of the glaucoma treatment device;
Figure 5 illustrates an end view oE the glaucoma treatment device;
Figures 6A-6F illustrate steps for a surgical procedure for implant of the glaucoma treatment device;
Figure 7 illustrates another embodiment of a glaucoma treatment device;
and Figure 8 illustrates an additional embodiment of a glaucoma treatment device.
DESCRIPTION OF THE PREFERRED EMbODIMENTS
Figure 1, which illustrates a side view of a glaucoma treatnlent device 10, shows the treatment device 10 surgically implantecl into an eye 12 and extending into the anterior chamber L4. The glaucoma treatment device 10 positions under a scleral flap or partial sc:Leral flap 18, and extends into the anterior chamber l~ of the eye 12. The process for surgical implantation is described in later detail :in the mode oE operation.
Figure 2, which illustrates a perspective view of the glaucoma treat-ment device 10, shows a cylindricaL member o-f a f:inite continuous Zength 20 ancl a diameter in the range of O.Olmm to 5mm, preferably 0~25mm. The cylind-rical member can consist of a synthetic material such as polymethylmethacrylate~

hereinafter referrecl to as PMMA, a term oE the art, by way of example and for purposes of illustration onlyl or a like material. The member 20 includes two encls 22 and 2~" two longitudinally extending and outwardly angled members 26 a[lc1 28, alld two small loops 30 and 32 having outer ends 34 and 36 connected to oppos:Lng encls 38 and 40 of the member 20. Inner ends 38 and 40 of the small Loops 3U ancl 32 respectively connect to ends 42 and 44 oE an elongated large loop 46 having a major radius in the member 20. The large loop 46 is in sub-stantiaLly a first plane as all the outwardly extending members 26 and 28. The small loops 30 and 32 are substantially in the same plane, referenced as a second plane. The joining of the ends of the small loops ~0 and 32 to the ends of the extending members 26 and 28 and ~le large loop 46 with curvature seg-ments 48, 50, 52 and 54 form a third plane at the tangent to the curved segments 48-54. The angle between the first plane and second plane is less than 90 .
m e angle of the third plane to either the first or second plane is less than 9oo ~
Figure 3, which illustrates a bottom view of the glaucoma treatment device lO, shows the large loop ~6, and the small loops 30 and 32. All other numerals correspond to those elements previously described. The extending members 26 and 28 and the large loop 46 position in the area of the scleral flap. m e large loop 46 is secured with a suture, as later described in detail.
The small loops 30 and 32 posit:ion into the anterior chamber of the eye.
Figure 4, which illustrates a side view of the glaucoma treatment device lO, shows the first plane 56, the second plane 58 and the third tangen-tial plane 60 where the first plane 56 engages under the scleral flap or partial scleral flap, the third plane 60 positions into the anterior chamber of the eye and the second plane 58 loops over the area of the canal of schlemm and trabe-cular meshwork if these anatomical parts are not removed during surgery.

Figure 5, which illustrates an end view of the glaucoma treatment clevice l0, shows the small loops 30 and 3~, and the large loop 46. Geometrical spaces 62 ancl 64 correspond to the spacing between the elongated large loop 46 and the members 26 ancl 28. Geometrical space 66 is providecl by the ends 42 ancl ~4, the large e:longated :Loop 46 narrowing at the connect-ion to the ends 3~ and 40.
PR~FERR ~ MO~E OF OPERATION
The glaucoma treatment device 10 can be implantecl by known ophthalmo-logical surgical procedures. Af ter the patient is diagnosed as having glaucoma and it is determined that the glaucoma treatment device 10 is the preferred treatment and management procedure, the patient is prepared rcor surgery and anaesthetized either with local or general anaesthesia.
Figures 6A-6F illustrate a surgical implant procedure generally invo:Lv-ing six steps. Figure 6A, the first step, is to create a scleral flap or partial scleral flap 72 at the limbus 74 which hinged portion thereof is verti-cal but can also be horizontal and parallel with the limbus. Figure 6B, the second step, is to slit (7~) the flap. Figure 6C, the third step, is to create a slit 78 into the anterior chamber of the eye and may be at the discretion of the surgeon to remove a section of the canal of schlemm and/or to remove a portion of the trabecular meshwork providing for access to the anterior chamber of the eye as in the trabeculectomy procedure. An irredectomy procedure 77 can also ~be utilized.
Figure 6~ illustrates the surgical implant of the glaucoma treatment device 10, the fourth step, where the device 10 is positioned such that the small loops 30 and 32 extend into the anterior chamber 14 of the eye 12 about the area of the canal of schlemm 68 ancl the trabecular meshwork 70 whether or not either has been removed. The elongclted large loop ~-~6 and the members 26 and 28 can engage between the surfaces o-F the canal of schlemm 68 and the trabecular meshwork 70 or in the immediate area thereof. The small loops 30 ancl 32 protrude into the anterior chamber 14 o:F the eye 12. The three loops 30, 3Z and 46 respectively with the other connecting structure provi~e a channeL :For the aqueous humor to discharge and flow from the interior of the eye.
The glaucoma treatment clevice lO provides that the eclges of the scleral flap about the area of the canal of schlemm 68 and trabecular mesh-work 70 are maintained in a somewnat spaced relationship allowing for aqueous humor to discharge along, in between, and around the chamlels pro-vided by the predetermined geometrical shape of the treatment device 10, and about the channels maintained and provided by the small loops 30 and 32 and the channels provided by the large loop 46.
The gl.aucoma treatment device 10 forms a channel providi.ng a pathway for the discharge of aqueous humor to leave the eye by a means other than the normal primary pathway which is the canal of schlemm~ The syn-thetic material, in this instance polymethylmethacrylate, of the glaucoma treatment device by virtue of the design and method of manufacture provides a smooth, flexible device which is securely positioned at implantation which enhances the operati.on in the management and treatment of glaucoma and is deformable with the eye. The device 10 or implant, due to its ]ight weight and the predetermined geometrical loop structure, is not noticeable to the individual patient and is barely perceptible to the touch. Figure 6D shows the glaucoma treatment device :L0 sutured into position at the end of the elongated large loop 46 to the sclera 68 with a suture 80.
Figure 6E illustrates positioning and securing of the glaucoma treatment device 10 where the members of the split scleral flap 18 are ~_ sutured down across the extending members 26 and 28 and over the large loop 46 w:ith a p3urality of sutures, usualLy two to four.
Figure 6F illustrates that after the eye has been surgically losed, the anterior chamber o~ the eye is reconstituted wlth air 82.
Depend:ing upon the surgical procedure, it is foreseeable that the surgeorl cou]d implant the glaucoma treatment device by p:iercing the anterior chamber and imp3anting the device only, cloing a combined procedure, implant and trabeculectomy including irridectomy 77.
Also, in the alternative, a vertical dissection of the scleral flap can be surgically performed at a 90 angle to the limbus, resulting in a hinge at a 90 angle to the limbus in lieu of a horizontal clissection at the :Limbus.
By way of example and for purposes of il:Lustration only, the glaucoma treatment device can have dimensions such as 3.5mm wide at outward extending members 26 and 28, 3mm in length for height of the extending members, and lmm in length for height of the small loops 30 and 32. The dimensions are not to be constn1ed as limiting Or the present invention.
ALTERNATIVE _MBODIMENTS
Figure 7, which illustrates another embodiment o-E a glaucoma treat-ment device having only one small loop, shows a glaucoma treatment device lOO
having two extending members :L02 and :L04 and a small loop 106. Structure and Peration is similar to that previously described. The device lOO is smaller in wiclth than that of device lO in having one fewer small loop and absent the large loop.
Figure 8, which illustrates an additional embodin)ent of a g:Laucoma treatment device having two large elongated loops and three small loops disposed therebetween, shows a glaucoma treatment device 200 having two _g _ extending members 202 and 204, three small loops 206, 20~ and 210~ and two largc loops 212 and 214. Structure and operation are similar to that pre-v-iously clescribed. The device 200 ls larger in width than that oE device 10 :in having one additional small and large loop.
Other embodiments are within the apparent scope oE the present invention without departing from the disclosure of the specification. Other predetermined geometricaL shapes can accomplish the same result with like geometrical structures of predeterminecl shapes. While the glaucoma treatment devices have illustrated an elongated circle and Loops, other geometrical configurations such as circles, ovoids, parabolas, and ellipses of the cyl-indrical member can be utilized. ~le elongated large loop can assume another like predetermined, geometrical shape than that d:isclosed. The small loop or loops can assume any other geometrical shapes than those disclosed, whether the shapes are identical or difEerent. Likewise, the analogy applies to all the figures. The continuous cylindircal member while being disclosed as being solid can also be tubular. The cylindrical member itself can assume other predetermined geometrical cross sections such as ovoid, square, rectangular, elliptical, or other predeterminecl geometrical cross section. The geometrical cross section can vary over the length of the cylindrical member.
Any suitable type of synthetic or like material coulcl a]so be used to form the cylindrical member, although the cylindrical member could assume any other predetermined geometrical conEiguration. The length and width of the glaucoma treatment dev-ice is determined by the particular geo-metrical configuration or geometrical configurations. Tlle synthetic material is such a type as being cleformable and flexible to the touch and normal phy-sical movements, but maintaining a predetermined geometrical shape through memory of that predetermined geometrical shape.
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Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. Glaucoma treatment device for treating disease of glaucoma in the human eye by surgical implant, said device comprising:
a. means including at least two small geometrical loop means of a small diameter and a large slightly elongated loop in a plane with said two small loop means and connected to said ends of said small loops for positioning within a portion of the eye; and, b. means including two substantially aligned parallel members connected to said loop means at an angle for positioning in at least a partial scleral flap of said eye, and connected at an angle to said loop means whereby said device provides a canal between said loop means and said member means thereby providing for discharge of aqueous humor from interior of said eye.

2. Glaucoma treatment device of claim 1 wherein said loop means comprises three small loop means connected to each other and large slightly elongated loops in a plane with said small loop means and connected to ends of said small loops.

3. Glaucoma treatment device of claim 2 wherein comprising two large slightly elongated loops in a plane with said members and connected to ends of small loop means.

4. Glaucoma treatment device of claim 1 wherein said loop means comprise a continuous cylindrical member of continuous length forming said loop means and said members.

5. Glaucoma treatment device of claim 4 wherein said cylindrical member is polymethylmethacrylate.

6. Glaucoma treatment device of claim 5 wherein said cylindrical member is of a diameter in the range oE 0.01 to 5.0 millimeters.

7. Glaucoma treatmen-t device of claim 5 wherein said cylindrical member is substantially of a diameter of 0.25 mm.

8. Glaucoma treatment device of claim 5 wherein said loop means substantially are of a height of 1 mm and said member means are substantially of a heigh-t of 3 mm and a width of 3.5 mm.

9. Glaucoma treatment device of claim 1 wherein said loop means are at an angle to said member means in the range of less than ninety degrees.

10. Glaueoma treatment device of elaim 1 eomprlsing a third means conneeting said first means to said seeond means.

11. Glaucoma treatment device of claim 1 wherein said loop means and said member means eonsist of fle~ible polymethyl me-thaerylate ma-terial.

12. Glaucoma treatment device for surgieal implan-t in an eye, said device comprising:
a. at least two small loop means on one plane providing a discharge channel from an anterior chamber of said eye; and, b. at least one large loop means connecting between said two small loop means and two member means connected to outer ends of said small loop means providing channels for surfacing within sclera of said eye whereby said discharge channel means and said channel surface member means provide for discharge of aqueous humor from an anterior chamber of said eye.

13. Glaucoma treatment device comprising:
a. continuous finite length of a geometrical member, said member including a substantially identical geometrical cross section at each increment of said finite length including two ends in a first plane;
b. at least two small loop means in a second plane at an angle to said first plane and each outer end of said loop means connected to said ends; and, c. at least one elongated large loop including a major radius in said first plane and connected between each of said small loop means whereby said small loop means are surgically implanted into an anterior chamber of an eye and said large loop and ends are under a scleral flap or partial scleral flap of said eye thereby securing a channel for discharge of aqueous humor to flow away from said eye for decrease of pressure.