Source: http://www.google.com/patents/US20100030150?ie=ISO-8859-1
Timestamp: 2014-10-21 04:53:48
Document Index: 506676746

Matched Legal Cases: ['art.\n30', 'art.\n35', 'Application No. 07360002', 'Application No. 07360001', 'art 137', 'art 137', 'art 237', 'art 237', 'art 237', 'art 337', 'art) 4211', 'art) 4212', 'art 4211', 'art 4212', 'art 4211', 'art 4212', 'art 4211', 'art 4211', 'art 4212', 'art 4211', 'art 4212', 'art 4212', 'art 5211', 'art 5211', 'art 5212', 'art 5212', 'art 5211', 'art 5212', 'art 5212', 'art 6211', 'art 6212', 'art 6211', 'art 6211', 'art 6211', 'art 637', 'art 6212', 'art 6211', 'art 6212', 'art 6211', 'art 6211', 'art 6211', 'art 6211', 'art 6212', 'art 6212', 'art 6211', 'art 6212', 'art 6212', 'art 7212', 'art 7211', 'art 7212']

Patent US20100030150 - Apparatus for intra-ocular injection - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsThe application relates to an apparatus for intraocular injection comprising a plate adapted for being brought into contact with an eye and guiding means for guiding a needle into the interior of an eye, characterized in that the plate comprises a cut-out having an edge adapted to be positioned along...http://www.google.com/patents/US20100030150?utm_source=gb-gplus-sharePatent US20100030150 - Apparatus for intra-ocular injectionAdvanced Patent SearchPublication numberUS20100030150 A1Publication typeApplicationApplication numberUS 12/520,940PCT numberPCT/EP2008/050203Publication dateFeb 4, 2010Filing dateJan 9, 2008Priority dateJan 9, 2007Also published asCA2674877A1, CA2674891A1, EP2124856A1, EP2124857A1, US8460242, US20100010452, WO2008084063A1, WO2008084064A1Publication number12520940, 520940, PCT/2008/50203, PCT/EP/2008/050203, PCT/EP/2008/50203, PCT/EP/8/050203, PCT/EP/8/50203, PCT/EP2008/050203, PCT/EP2008/50203, PCT/EP2008050203, PCT/EP200850203, PCT/EP8/050203, PCT/EP8/50203, PCT/EP8050203, PCT/EP850203, US 2010/0030150 A1, US 2010/030150 A1, US 20100030150 A1, US 20100030150A1, US 2010030150 A1, US 2010030150A1, US-A1-20100030150, US-A1-2010030150, US2010/0030150A1, US2010/030150A1, US20100030150 A1, US20100030150A1, US2010030150 A1, US2010030150A1InventorsMichel Paques, Pierre RoyOriginal AssigneeFovea Pharmaceuticals, Fondation Ophtalmologique Adolphe De RothschildExport CitationBiBTeX, EndNote, RefManPatent Citations (4), Referenced by (14), Classifications (6), Legal Events (1) External Links: USPTO, USPTO Assignment, EspacenetApparatus for intra-ocular injectionUS 20100030150 A1Abstract The application relates to an apparatus for intraocular injection comprising a plate adapted for being brought into contact with an eye and guiding means for guiding a needle into the interior of an eye, characterized in that the plate comprises a cut-out having an edge adapted to be positioned along the limbus delimiting the cornea and the sclera of the eye, so as to adjust the position of the guiding means with respect to the limbus.
1. An apparatus for intraocular injection comprising a plate adapted for being brought into contact with an eye and a guide operably guiding a needle into the interior of an eye, the plate further comprising a cut-out having an edge adapted to be positioned along the limbus delimiting the cornea and the sclera of the eye, so as to adjust the position of the guide with respect to the limbus.
2. The apparatus according to claim 1, wherein the edge of the cut-out is of substantially circular shape.
3. The apparatus according to claim 1, wherein the edge of the cut-out has a shape which corresponds to a shape of a limbus so that the edge can be superimposed on the limbus.
4. The apparatus according to claim 3, wherein the cut-out is arranged in the plate such that when the edge of the cut-out is superposed on the limbus, the plate extends over the sclera of the eye.
5. The apparatus according to claim 1 4, wherein the cut-out and the guide are arranged so that the needle penetrates into the eye through the sclera at a distance of about 3.5 millimetres from the limbus.
6. The apparatus according to claim 1, wherein the plate has an eye bearing surface having a curved shape for matingly bearing on the outer surface of the eye.
7. The apparatus according to claim 1, wherein the guide comprises a support having a hollow body adapted for receiving a barrel of a syringe, such that the syringe can slide relative to the body.
8. The apparatus according to claim 7, wherein the syringe is movable relative to the body from a retracted position wherein a needle of the syringe is retracted inside the body, to an injection position wherein the needle protrudes outside the body.
9. The apparatus according to claim 8, comprising a syringe barrel and a syringe plunger, wherein operating a plunger of the syringe received inside the hollow body sequentially slides the syringe towards the injection position and then slides the plunger relative to the barrel.
10. The apparatus according to claim 8, wherein the support comprises a bearing surface against which a rim of the syringe can abut, so that operating a plunger of the syringe causes sequentially the syringe to slide relative to the body towards the injection position until the rim of the barrel abut against the bearing surface and then the plunger to slide into the syringe barrel.
11. The apparatus according to claim 8, comprising a releasable connector operably connecting a syringe plunger and a syringe barrel of the syringe in common sliding movement relative to the body and releasing said connection at a predetermined position of the syringe relative to the body.
12. The apparatus according to claim 11, wherein the releasable connector comprises at least one elastic member prestressed against an inner wall of the body, said inner wall having a housing for accommodating the elastic member when the syringe reaches the predetermined position so as to release the elastic member, whereby the plunger is allowed to slide relative to the barrel.
13. The apparatus according to claim 12, wherein the releasable connector comprises a spacer arranged between the syringe barrel and the syringe plunger to prevent sliding movement of the plunger relative to the barrel.
14. The apparatus according to claim 12, wherein the spacer has grooves for receiving fingers of the plunger and the prestressed elastic member is adapted for preventing the fingers from sliding in the grooves until the elastic member is released.
15. The apparatus according to claim 8, comprising a push button for operating the plunger.
16. The apparatus according to claim 7, wherein the support comprises a finger bearing flange projecting outwardly from the body for an operator to retain the support when sliding the syringe relative to the body.
17. The apparatus according to claim 1, comprising a syringe barrel and a syringe needle, wherein the syringe barrel comprises a carpule sealed by a protective cap, the needle being movable rearwards relative to the carpule for simultaneously connecting the needle to the barrel to assemble the syringe and piercing the protective cap with the needle, before moving the assembled syringe towards an injection position.
18. The apparatus according to claim 17, comprising a needle support for supporting the syringe needle, the needle support being operable from outside the body for moving the needle relative to the carpule in order to pierce the protective cap.
19. The apparatus according to claim 17, comprising a removable safety ring for preventing movement of the needle relative to the body.
20. The apparatus according to claim 1, comprising means for displacing a superficial layer of the eye over an underlying layer of the eye as the plate is brought into contact with the eye before the needle is guided into the interior of the eye.
21. The apparatus according to claim 20, wherein the means for displacing a superficial layer over an underlying layer comprises a resilient member which can be bent when urged against the superficial layer, wherein the resilient member applies a tangential force to the superficial layer.
22. The apparatus according to claim 21, wherein the resilient member comprises a flexible leg protruding from the plate.
23. The apparatus according to claim 21, wherein the means for displacing a superficial layer over an underlying layer comprises means for engaging the superficial layer.
24. The apparatus according to claim 23, wherein the means for engaging the superficial layer comprises at least one tooth.
25. The apparatus according to claim 22, wherein a tooth is provided at a free end of the flexible leg.
28. The apparatus according to claim 27, wherein the locking member comprises a locking projection which can be accommodated in a locking recess, the apparatus comprising a remover operably removing the locking projection from the locking recess, allowing movement of the mobile part relative to the fixed part.
30. The apparatus according to claim 26, comprising a rubbing member which generates friction between the fixed part and the mobile part to slow down the movement of the mobile part relative to the fixed part.
35. The apparatus according to claim 31, wherein the resilient member exerts a restoring force which causes the syringe to spontaneously retracts into the hollow body after injection.
CROSS-REFERENCE TO RELATED APPLICATIONS This application is a National Phase Entry of International Application No. PCT/EP2008/050203, filed Jan. 9, 2008, which claims priority to European Application No. 07360002.5, filed on Jan. 9, 2007 and European Application No. 07360001.7, filed on Jan. 9, 2007, all of which are incorporated by reference herein.
FIELD OF THE INVENTION The present invention relates to apparatus and methods for treating eyes, such as eyes of mammals having eye disorders or diseases, more particularly to apparatus and methods for administering a therapeutic medium or agent intravitreously, yet more particularly to apparatus and methods for administering such therapeutics or agents to the tissues of the eye so that the pharmaceutical action of the such therapeutics/agents is localized at the choroid and the retina, or at the ciliary body or the lens.
BACKGROUND OF THE INVENTION There are a number of vision-threatening disorders or diseases of the eye of a mammal including, but not limited to diseases of the retina, retinal pigment epithelium (RPE), ciliary body, lens and choroid. Such vision threatening diseases include, for example, ocular neovascularization, ocular inflammation and retinal degenerations. Specific examples of these disease states include diabetic retinopathy, glaucoma, chronic glaucoma, posterior capsule opacification, retinal detachment, sickle cell retinopathy, age-related macular degeneration, retinal neovascularization, subretinal neovascularization; rubeosis iritis inflammatory diseases, chronic posterior and pan uveitis, neoplasms, retinoblastoma, pseudoglioma, neovascular glaucoma; neovascularization resulting following a combined vitrectomy and lensectomy, vascular diseases, retinal ischemia, choroidal vascular insufficiency, choroidal thrombosis, neovascularization of the optic nerve, diabetic macular edema, cystoid macular edema, macular edema, retinitis-pigmentosa, retinal vein occlusion, proliferative vitreoretinopathy, angioid streak, and retinal artery occlusion, and, neovascularization due to penetration of the eye or ocular injury.
As a consequence most methods for treating eye disorders or diseases in the posterior segment, or the back-of-the-eye, involve intraocular (and more specifically intravitreal) delivery of the drug. One such technique for intravitreal delivery is accomplished by intraocular injection of the drug or microspheres containing the drug directly into the vitreous or by locating a device or capsule containing the drug in the vitreous, such as that described in U.S. Pat. No. 5,770,589. Intraocular injection is commonly used in ophthalmology for delivering therapeutics or agents (e.g. drugs of interest) to the posterior segment of the eye, especially when it is useful to deliver high concentrations of drugs. Such an operation is used in particular for injecting compositions comprising for example corticosteroids or neovascularization inhibitors in the vitreous body of the eye, in order to treat diseases affecting retina or choroids, or ciliary body or lens.
moving apart the eyelids with an eyelids retractor, locating an injection area on the eye using a compass, introducing the needle into the eye at the level of the injection area, and injecting a composition via the needle and removing the needle while pressing the superficial layers of the eye in the injection area in order to limit the risk of leakage of the injected substance.
SUMMARY OF THE INVENTION It is an object of the invention to provide an apparatus for intraocular injection which is adapted to a large number of eyes. This problem is solved according to the invention thanks to an apparatus for intraocular injection comprising a plate adapted for being brought into contact with an eye and guiding means for guiding a needle into the interior of an eye, characterized in that the plate comprises a cut-out having an edge adapted to be positioned along the limbus delimiting the cornea and the sclera of the eye, so as to adjust the position of the guiding means with respect to the limbus.
The cut-out serves as a reference to position the guiding means with respect to the limbus, delimiting the cornea and the sclera of the eye. Therefore, the position of the guiding means is adjusted with respect to the limbus (not with respect to the centre of the iris). This feature allows precise positioning of the guiding means, even in case of cornea of non-standard diameter.
FIG. 18 is a cut-away view of the apparatus of FIGS. FIGS. 16 and 17;
FIG. 59 and 60 are schematic views of possible forms of flexible legs which can be used in the apparatus represented on FIGS. 1 to 58.
DESCRIPTION OF PREFERRED EMBODIMENTS FIGS. 1 to 3 illustrate an apparatus 100 for intra-ocular injection according to a first embodiment of the invention. The apparatus 100 comprises a plate 110 adapted for being brought into contact with an eye, a support 120 for receiving a syringe and optionally a syringe 130. The plate 110 has an eye bearing surface 111 having a curved shape for matingly bearing on the outer surface of the eye and an aperture 112 provided in the plate 110 for allowing a needle to pass through the plate 110.
Moreover, the plate 110 has a cut-out 113 having an edge 114 with a curved shape. More precisely, the edge of the cut-out has a substantially circular shape which corresponds to a shape of a limbus (as shown in dofted line on FIG. 2) so that the edge 114 can be superimposed on the limbus. The cut-out 113 has a diameter of about 12 millimetres. The cut-out serves as a reference for precisely positioning the apparatus with respect to the eye in order to perform an intra-ocular injection. The cut-out 113 is provided in the plate 111, such that when the cut-out is superimposed on the limbus, the aperture 112 is located at a distance of about 3.5 millimetres from the limbus.
According to a preferred embodiment, the support 120 also comprises a first bearing surface 124 against which a rim of the syringe barrel can abut. The bearing surface 124 is substantially flat, has an annular shape and extends in a radial direction relative to the axis of the guiding channel 122. In the example of FIG. 3, the bearing surface 124 is arranged in a recess provided in the annular flange 123. Moreover, the support 120 comprises a second bearing surface 125 against which a rim of a needle support can abut. The bearing surface 125 is formed by a shoulder in the guiding channel 122.
The guiding channel 122 has an inner diameter which corresponds to the outer diameter of the syringe barrel 130, so that the syringe is guided into the support 120. The syringe barrel 131 has an annular rim 135 which can abut against the bearing surface 124 for limiting the sliding movement of the syringe into the guiding channel 122. According to preferred embodiment, the needle support 134 also has an annular rim 136 which can abut against the bearing surface 125 for limiting penetration of the needle 133 into the eye.
And in a known manner, the plunger 132 has an enlarged part 137 which is used by an ophthalmologist to apply a pressure on the plunger 132 in order to make it slide into the barrel 130. The enlarged part 137 can abut against the syringe barrel 131 for limiting the sliding movement of the syringe plunger 132 into the syringe barrel 130. On FIGS. 1 to 3, the syringe is represented in a retracted position, in which the needle 133 extends inside the hollow body 121.
The apparatus 100 also comprises a resilient member 140 for displacing a superficial layer of the eye over an underlying layer of the eye. The resilient member 140 comprises a flexible leg 141 projecting outwardly from the plate 110 from the side of the bearing surface 111 and a plurality of teeth 142 arranged at the free end of the flexible leg 141. The flexible leg 141 extends in a direction substantially tangential with respect to the edge 114 of the cut-out 113.
FIGS. 4 to 8 illustrate different steps of a method for performing intra-ocular injection using the apparatus 100. According to a first step (FIG. 4), the ophthalmologist bring the apparatus 100 into contact with an eye. During this step, the resilient member 140 comes first into contact with the eye. More precisely, the teeth 142 provided a free end of the flexible leg 141 engage a superficial layer 1 of the eye (called �conjunctiva�) extending over an underlying layer 2 (called �sclera�). The teeth 141 engage the superficial layer 1 in a zone where the superficial layer 1 is mobile relative to the underlying layer 2 (i.e. around the limbus) and where the layers of the eye are compact.
The sliding movement of the syringe is stopped by the needle support 134 coming into abutment against the second bearing surface 125. The second bearing surface 125 is arranged such that the stroke of the syringe is h, in order that the needle 133 penetrates into the eye at a depth of about 3 to about 10 millimetres (e.g. 6 millimetres). By limiting the stroke of the needle 133, the second bearing surface 125 prevents the needle from damaging intraocular structures such as the retina or lens.
According to a fourth step (FIG. 7), the ophthalmologist carry on applying a pressure on the plunger 132. As a consequence, the plunger 132 slides into the barrel 131, whereby the composition is pushed out of the barrel 131 and injected into the eye via the needle 133. The third and fourth steps are performed successively while the ophthalmologist is continuously applying a pressure on the plunger 132. This is due to the fact that the force required for moving the syringe 130 relative to the body 121 is lower than the force required for moving the plunger 132 relative to the barrel 131.
The support 220 comprises a hollow body 221 extending over the aperture 212 and comprising an inner guiding channel 222 adapted for receiving the syringe 230 in such a way that the syringe 230 can slide into the guiding channel 222. The support 220 comprises an annular flange 223 which projects outwardly from the body 221, in a radial direction relative to the axis of the guiding channel 222. The annular flange 223 allows an operator to retain the support when sliding the syringe 230 relative to the body 221. The support 220 also comprises a bearing surface 224 against which a rim of the syringe barrel can abut. The bearing surface 224 is substantially flat, has an annular shape and extends in a radial direction relative to the axis of the guiding channel 222.
The syringe 230 comprises a syringe barrel 231, a syringe plunger 232, a syringe needle 233 and a needle support 234. On FIGS. 12 to 13, the syringe is represented in a retracted position, in which the needle 233 extends inside the hollow body 221. According to this second embodiment, the syringe plunger 232 comprises two fingers 238 extending in two opposite radial directions from the enlarged part 237.
Moreover, according to this second embodiment, the apparatus 200 comprises a spacer 251 and an elastic open ring 252 arranged between the syringe barrel 231 and the syringe plunger 232 to prevent sliding movement of the plunger relative to the barrel. The spacer 251 has a generally cylindrical shape. The spacer 251 comprises two opposite longitudinal grooves 253 and an annular radial rim 254. Each groove is 253 is adapted for receiving a finger 238 of the plunger 232 so that the finger can slide in the associated groove. Moreover, when the apparatus 200 is in a retracted position, the elastic open ring 252 is prestressed in the hollow body 221. The elastic open ring 252 extends around the spacer 251 and is interposed between the fingers 238 of the plunger 232 and the rim 254 thereby preventing the fingers 238 from sliding in the grooves 253.
The support 220 comprises a housing 227 in the form of an annular groove provided in the internal surface of the guiding channel 222. The housing is adapted for accommodating the elastic ring when the apparatus is brought to the injection position. The support 220 also comprise a lid 228 for maintaining the syringe 230, the spacer 251 and the elastic ring 252 inside the guiding channel 222, and a push button 229 which can be operated for applying a pressure on the plunger 232.
FIGS. 14 and 15 illustrate the kinematics of the apparatus 200 when the ophthalmologist applies a pressure on the push button 229. During a first phase (FIG. 14), the push button 229 presses on the enlarged part 237 of the plunger 232. As the spacer 251 and the elastic ring 252 prevent relative movement between the plunger 232 and the barrel 231, the syringe plunger 232 and a syringe barrel 231 are caused to move in a common sliding movement relative to the body 221.
As a consequence, the syringe 230 slides relative to the body 221 towards the injection position until the rim 235 of the barrel 231 abuts against the bearing surface 224 of the body 221. Moreover, the elastic ring 252 is caused to slide into the guiding channel 222 until the elastic ring 252 reaches the housing 227. Then the elastic ring 252 expands and fits into the housing 227, whereby the connection between the plunger 232 and the barrel 231 is automatically released.
During a second phase (FIG. 15), the push button 229 continue to press on the enlarged part 237 of the plunger 232. As the elastic ring 252 has been withdrawn in the housing 227, the fingers 238 are free to slide into the grooves 253 of the spacer 251. As a consequence, the plunger 232 slides into the barrel 231. The releasable connecting means 250 allows to sequentially slide the syringe towards the injection position and then slides the plunger relative to the barrel, in one gesture, by simply exerting a pressure on the push-bufton 229.
The support 320 comprises a hollow body 321 extending over the aperture 312 and comprising an inner guiding channel 322 adapted for receiving the syringe 330 in such a way that the syringe 330 can slide into the guiding channel 322. The support 320 comprises an annular flange 323 which projects outwardly from the body 321, in a radial direction relative to the axis of the guiding channel 322. The annular flange 323 allows an operator to retain the support when sliding the syringe 330 relative to the body 321. The support 320 also comprises a bearing surface 324 against which a rim of the syringe barrel can abut. The bearing surface 324 is substantially flat, has an annular shape and extends in a radial direction relative to the axis of the guiding channel 322.
The syringe 330 comprises a syringe barrel 331, a syringe plunger 332, a syringe needle 333 and a needle support 334. Similarly to apparatus 200, the apparatus 300 comprises releasable connecting means 350. The syringe plunger 332 comprises two fingers 338 extending in two opposite radial directions from the enlarged part 337.
The apparatus 300 comprises a spacer 351 having two opposite longitudinal grooves 353, and an elastic open ring 352 prestressed in the hollow body 321 when the apparatus 300 is in a retracted position. The support 320 comprises a housing 327 for accommodating the elastic ring 352 when the apparatus 300 is brought to the injection position. The support 320 also comprises a lid 328 and a push button 329.
Moreover, in this third embodiment, the syringe barrel 331 comprises a carpule 371 sealed by a protective cap 339. The protective cap 339 protects the composition contained inside the carpule 371. When the apparatus 300 is in a locked configuration, the syringe barrel 331 and the needle 333 are not connected to each other (the syringe is disassembled).
The needle support 334 can slide relative to the body 321 so as to translate the needle 333 relative to the carpule 371. The needle support 334 extends partially outside the body 321, so that it can be operated from outside of the body 321.
On FIGS. 16 to 18, the apparatus 300 is in a locked configuration wherein the safety ring 370 has not be removed yet and the syringe 330 is represented in a retracted position, the needle 333 extending inside the hollow body 321. The apparatus 300 is intended to be used in the same way as the apparatus 100 and 200 for performing an intraocular injection (FIGS. 4 to 8), except that it has to be unlocked before use.
According to a third step (FIGS. 21 and 22), once the syringe has been assembled, the ophthalmologist applies a pressure on the push button 329. Similarly to apparatus 200, in one gesture, by simply exerting a pressure on the push-bufton 329, the ophthalmologist sequentially causes the syringe 330 to slide towards the injection position (FIG. 21) wherein the needle 333 protrude outside the body 321 and then the plunger 332 to slide relative to the barrel 331 (FIG. 22) in order to inject the composition inside the eye.
The support 420 comprises a hollow body 421 extending over the aperture 412.
According to this fourth embodiment, the hollow body 421 is made of two parts: a first fixed part (or inner part) 4211 which is connected to the plate 410 and a second mobile part (or outer part) 4212 surrounding the inner part 4211. The outer part 4212 is mobile relative to the inner part 4211. More precisely, the outer part 4212 is adapted for sliding along the inner part 4211.
The inner part 4211 comprises an inner guiding channel 422 adapted for receiving the syringe 430 in such a way that the syringe 430 can slide into the guiding channel 422. The syringe 430 comprises a syringe barrel 431, a syringe plunger 432, a syringe needle 433 and a needle support 434.
Moreover, according to this fourth embodiment, the locking member 4213 comprises a button 4214. The button 4214 is formed by two curved slots 4215 provided through a wall of the outer part 4212. The slots 4215 delimit a hinge 4216 which allow the button 4214 to be switched. The button 4214 comprises a locking lug 4217 and a friction leg 4218. The inner part 4211 of the body 421 comprises a bulge 4219 and a groove 4220 for accommodating the locking lug 4217 when the apparatus is in the locked configuration. The groove 4220 is formed at a thickest section of the bulge 4219.
According to a fifth step (FIG. 29), the ophthalmologist carries on applying a pressure on the outer part 4212. As a consequence, the helical spring 454 is compressed between the syringe barrel 431 and the lid 428. The plunger 432 slides into the barrel 431, whereby the composition is pushed out of the barrel 431 and injected into the eye via the needle 433. Similarly to apparatus 200 and 300, in one gesture, by simply exerting a pressure on the outer part 4212, the ophthalmologist sequentially causes the syringe 430 to slide towards the injection position (FIG. 28) wherein the needle 433 protrude outside the body 421 and then the plunger 432 to slide relative to the barrel 431 (FIG. 29) in order to inject the composition inside the eye.
The apparatus 500 is similar to apparatus 400, except that the locking member 5213 comprises a first locking leg 5214 extending from the inner part 5211 of the body 521. The leg 5214 has one end connected to the inner part 5211 and another free end provided with a locking tooth 5217. The outer part 5212 comprises an opening 5220 for accommodating the locking tooth 5217.
When the locking tooth 5217 is in the opening 5220, the apparatus 500 is in a locked configuration wherein the locking member 5213 prevents movement of the outer part 5212 of the body 521 relative to the inner part 5211. The apparatus 500 also comprises an unlocking member 5216 comprising a second unlocking leg 5216 extending from the outer part 5212. The unlocking leg 5216 has one end connected to the outer part 5212 and another free end provided with an unlocking tooth 5218 facing the opening 5220.
FIGS. 38 to 40 illustrate an apparatus 600 for intra-ocular injection according to a sixth embodiment of the invention. The apparatus 600 comprises a plate 610, a support 620 and a syringe 630. The plate 610 has an eye bearing surface 611, an aperture 612 and a cut-out 613 having an edge 614.
The support 620 comprises a hollow body 621 extending over the aperture 612. The hollow body 621 is made of an inner part 6211 and an outer part 6212 surrounding the inner part 6211, the outer part being mobile relative to the inner part 6211. The inner part 6211 comprises an inner guiding channel 622 adapted for receiving the syringe 630 in such a way that the syringe 530 can slide into the guiding channel 622.
The syringe 630 comprises a syringe barrel 631, a syringe plunger 632, a syringe needle 633 and a needle support 634. The support 620 also comprises a lid 628 comprising two retaining legs 6281 adapted for holding the enlarged part 637 of the barrel 631 between them. Moreover, the support 620 comprises a locking member 6213 which prevents movement of the outer part 6212 of the body 621 relative to the inner part 6211 when the apparatus is in a locked configuration.
The apparatus 600 is similar to apparatus 400 and 500, except that the locking member 6213 comprises a leg 6214 connected to the outer part 6212 of the body 621 and a locking fork 6215 connected to the leg 6214. The locking fork 6215 has two side branches 6216 extending on both sides of the inner part 6211 of the body 621, each side branch 6216 having a curved end 6217. Moreover, the inner part 6211 has two grooves 6220 provided on the outer wall of the inner part 6211, for accommodating the ends 6217 of the side branches 6216 when the apparatus is in the locked configuration. The grooves 6220 extends on the inner part 6211 substantially transversally relative to the direction of movement of the outer part 6212. When the ends 6217 of the side branches 6216 are in the grooves 6220, the apparatus 600 is in a locked configuration wherein the locking member 6213 prevents movement of the outer part 6212 of the body 621 relative to the inner part 6211 (FIGS. 38 to 40).
The apparatus 600 can be operated in the same way as the apparatus 400 and 500 (as illustrated on FIGS. 41 to 44). In order to unlock the apparatus 600, the ophthalmologist pushes the leg 6214 (FIGS. 42 and 46) toward the body 621, whereby the ends 6217 of the locking fork 6215 slide into the grooves 6220 until they get out of the grooves 6220. When the ends 6217 are removed from the grooves 6220, the apparatus 600 is unlocked. The apparatus 600 stands in an unlocked configuration wherein the outer part 6212 can slide along the inner part 6212. Moreover, during the sliding of the syringe 630 into the guiding channel 622, the helical spring 654 prevents a sliding movement of the plunger 632 relative to the barrel 631 (FIG. 43).
FIGS. 48 to 54 illustrate different steps of a method for performing intra-ocular injection using an apparatus 700 according to a seventh embodiment of the invention. The apparatus 700 comprises a plate 710 adapted for being brought into contact with an eye, a support 720 for receiving a syringe and optionally a syringe 730. The plate 710 has an eye bearing surface 711 having a curved shape for matingly bearing on the outer surface of the eye and an aperture 712 provided in the plate 710 for allowing a needle to pass through the plate 710.
FIGS. 48 to 54 illustrate different steps of a method for performing intra-ocular injection using the apparatus 700. According to a first step (FIG. 48), the syringe 730 is filled with a compound or composition of interest (i.e. the therapeutic medium). According to a second step (FIG. 49), the syringe 730 is inserted in the inner guiding channel 722 and the syringe barrel 731 is locked to the outer part 7212 of the body 721.
According to a fifth step (FIG. 52), the ophthalmologist carry on applying a pressure on the plunger 732. As a consequence, the plunger 732 slides into the barrel 731, whereby the composition is pushed out of the barrel 731 and injected into the eye via the needle 733. The fourth and fifth steps are performed successively while the ophthalmologist is continuously applying a pressure on the plunger 732. This is due to the fact that the force required for moving the syringe 730 relative to the body 721 is initially lower than the force required for moving the plunger 732 relative to the barrel 731.
On FIG. 56, the apparatus 700″ further comprises an adaptor 728″ so that the apparatus can accommodate different types of syringes (with different diameters and/or lengths). On FIG. 57, the apparatus 700′″ comprises a helical spring 754 which is arranged between the inner part 7211 and the outer part 7212 of the body 721. According to this variant, the helical spring 754 is compressed when a pressure is applied on the plunger 732.
FIGS. 59 and 60 are schematic views of possible forms of flexible legs which can be used in the apparatus represented on FIGS. 1 to 58. On FIG. 59, the resilient member 140 comprises a flexible leg 141 and a plurality of teeth 142 (or pins) arranged at the free end of the flexible leg 141. Thereby the resilient member has a general shape of a �comb� or a �rake�. Alternatively, as shown on FIG. 60, the resilient member 140 can comprise a flexible leg 141 and a unique elongated tooth 142 (or rib). Thereby the resilient member has a general shape of a �scraper�.
According to particular embodiment, the syringe of the invention is containing a therapeutic medium and thus forms a reservoir of the therapeutic medium. In this way, the therapeutic delivery apparatus of the present invention provides a mechanism for intraocular administration or delivery of a therapeutic medium to a posterior segment of a mammalian eye, more particularly a human eye as well as a methodology for treating and/or preventing disorders and/or diseases of the eye, in particular retinal/choroidal disorders or diseases, through such intraocular administration of such therapeutic mediums. Such methodologies provide a mechanism for treating a wide array of diseases and/or disorders of an eye of a mammal, more specifically a human eye, and more particularly diseases or disorders involving the posterior segment of the eye such as retinal/choroidal disorders or diseases. Such a treatment/prevention methodology also is useable to treat/prevent a number of vision-threatening disorders or diseases of the eye of a mammal including, but not limited to diseases of the retina, retinal pigment epithelium (RPE), ciliary body, lens and choroid. Such vision threatening diseases include, for example, ocular neovascularization, ocular inflammation and retinal degenerations. Specific examples of these disease states include diabetic retinopathy, chronic glaucoma, posterior capsule opacification, retinal detachment, sickle cell retinopathy, age-related macular degeneration, retinal neovascularization, subretinal neovascularization; rubeosis iritis inflammatory diseases, chronic posterior and pan uveitis, neoplasms, retinoblastoma, pseudoglioma, neovascular glaucoma; neovascularization resulting following a combined vitrectomy and lensectomy, vascular diseases retinal ischemia, choroidal vascular insufficiency, choroidal thrombosis, neovascularization of the optic nerve, diabetic macular edema, cystoid macular edema, macular edema, retinitis pigmentosa, retinal vein occlusion, proliferative vitreoretinopathy, angioid streak, and retinal artery occlusion, and, neovascularization due to penetration of the eye or ocular injury. The methodology of the present invention also can be used to treat ocular symptoms resulting from diseases or conditions that have both ocular and non-ocular symptoms.
As used in the present invention, therapeutic medium includes any compound, agent or the like known in the art that when administered or delivered intraocularly (and more specifically intravitreously), is effective in obtaining a desired local or systemic physiological or pharmacological effect. More particularly, in the present invention, therapeutic medium includes, but is not limited to drugs, medicaments, antibiotics, antibacterials, antiproliferatives, neuroprotectives, anti-inflammatories (steroidal and non-sterodial), growth factors, neurotropic factors, antiangiogenics, thromobolytics or genes. Exemplary therapeutic mediums include, but are not limited to, thrombin inhibitors; antithrombogenic agents; thrombolytic agents; fibrinolytic agents; vasospasm inhibitors; calcium channel blockers; vasodilators; antihypertensive agents; antimicrobial agents, such as antibiotics (such as tetracycline, chlortetracycline, bacitracin, neomycin, polymyxin, gramicidin, cephalexin, oxytetracycline, chloramphenicol, rifampicin, ciprofloxacin, tobramycin, gentamycin, erythromycin, penicillin, sulfonamides, sulfadiazine, sulfacetamide, sulfamethizole, sulfisoxazole, nitrofurazone, sodium propionate), antifungals (such as amphotericin B and miconazole), and antivirals (such as idoxuridine trifluorothymidine, acyclovir, gancyclovir, interferon); inhibitors of surface glycoprotein receptors; antiplatelet agents; antimitotics; microtubule inhibitors; anti-secretory agents; active inhibitors; remodeling inhibitors; antisense nucleotides; anti-metabolites; antiproliferatives (including antiangiogenesis agents); anticancer chemotherapeutic agents; anti-inflammatories (such as hydrocortisone, hydrocortisone acetate, dexamethasone 21-phosphate, fluocinolone, medrysone, methylprednisolone, prednisolone 21-phosphate, prednisolone acetate, fluoromethalone, betamethasone, triamcinolone, triamcinolone acetonide); non-steroidal anti-inflammatories (such as salicylate, indomethacin, ibuprofen, diclofenac, flurbiprofen, piroxicam); antiallergenics (such as sodium chromoglycate, antazoline, methapyriline, chlorpheniramine, cetrizine, pyrilamine, prophenpyridamine); anti-proliferative agents (such as 1-3-cis retinoic acid); decongestants (such as phenylephrine, naphazoline, tetrahydrazoline); miotics and anti-cholinesterase (such as pilocarpine, salicylate, carbachol, acetylcholine chloride, physostigmine, eserine, diisopropyl fluorophosphate, phospholine iodine, demecarium bromide); antineoplastics (such as carmustine, cisplatin, fluorouracil); immunological drugs (such as vaccines and immune stimulants); hormonal agents (such as estrogens, estradiol, progestational, progesterone, insulin, calcitonin, parathyroid hormone, peptide and vasopressin hypothalamus releasing factor); immunosuppressive agents, growth hormone antagonists, growth factors (such as epidermal growth factor, fibroblast growth factor, platelet derived growth factor, transforming growth factor beta, somatotropin, fibronectin); inhibitors of angiogenesis (such as angiostatin, anecortave acetate, thrombospondin, anti-VEGF antibody); dopamine agonists; radiotherapeutic agents; peptides; proteins; enzymes; extracellular matrix components; ACE inhibitors; free radical scavengers; chelators; antioxidants; anti-polymerases; photodynamic therapy agents; gene therapy agents; and other therapeutic agents such as prostaglandins, antiprostaglandins, prostaglandin precursors, and the like or combination thereof.
As is known to those skilled in the art, growth factors is a collective term originally used to refer to substances that promote cell growth and is now loosely used to describe molecules that function as growth stimulators (mitogens) but also as growth inhibitors (sometimes referred to as negative growth factors), factors that stimulate cell migration, or as chemotactic agents or inhibit cell migration or invasion of tumor cells, factors that modulate differentiated functions of cells, factors involved in apoptosis, factors involved in angiogenesis, or factors that promote survival of cells without influencing growth and differentiation. In the present invention, such growth factors include, but are not limited to, pigment epithelium derived factor and basic fibroblast growth factor. As is known to those skilled in the art, neurotropic factors is a general term used to describe growth factors and cytokines that can enhance neuronal survival and axonal growth and that regulate synaptic development and plasticity in the nervous system. In the present invention, such growth factors include, but are not limited to, ciliary neurotrophic factors and brain-derived neurotrophic factors.
Other factors contemplated for use in the present invention for retarding cell degeneration, promoting cell sparing, or promoting new cell growth include neurotrophin 4/5 (NT4/5), cardiotrophin-1 (CT-1), ciliary neurotrophic-factor (CNTF), glial cell line derived neurotrophic factor (GDNF), nerve growth factor (NGF), insulin-like growth factor-1 (IGF-1), neurotrophin 3 (NT-3), brain-derived neurotrophic factor (BDNF), PDGF, neurturin, acidic fibroblast growth factor (aFGF), basic fibroblast growth factor (bFGF), EGF, neuregulins, heregulins, TGF-alpha, bone morphogenic proteins (BMP-1, BMP-2, BMP-7, etc.), the hedgehog family (sonic hedgehog, Indian hedgehog, and desert hedgehog, etc.), the family of transforming growth factors (including, e.g., TGF.beta.-1, TGF.beta.-2, and TGF.beta.-3), interleukin 1-B (IL1-.beta.), and such cytokines as interleukin-6 (EL-6), IL-10, CDF/LIF, and beta-interferon (IFN-.beta.). In exemplary embodiments, the dosage of such factors being delivered to the sub-retinal space is contemplated as being in a dosage range of of 50 pg to 500 ng, preferably 100 pg to 100 ng, and most preferably 1 ng to 50 ng per eye per patient per day.
The therapeutic medium also can include a pharmaceutically acceptable carrier or excipient and/or one or more accessory molecules which may be suitable for diagnostic or therapeutic use in vitro or in vivo. The term �pharmaceutically acceptable carrier� as used herein encompasses any of the standard pharmaceutical carriers, such as a phosphate buffered saline solution, water, and emulsions, such as an oil/water or water/oil emulsion, and various types of wefting agents. The therapeutic medium also can include stabilizers and preservatives. For examples of carriers, stabilizers and adjuvants, see Martin Remington's Pharm. Sci., 15th Ed. (Mack Publ. Co., Easton (1975)).
It also should be recognized, that the therapeutic medium delivery apparatus and methodologies of the present invention are contemplated as being practiced alone, or in combination with other therapies or treatments (for example in combination with laser treatment) before and/or after said treatment. In addition, it is contemplated that the therapeutic medium can comprise a mixture of active agents or therapeutic agents such as for example antibiotics, medicaments, or agents, e.g., thalidomide, being administered along with a steroid.
Uveitis involves inflammation. The present invention contemplates treating uveitis by instilling or disposing one or more anti-inflammatory factors in the intraocular space. Retinitis pigmentosa, by comparison, is characterized by retinal degeneration. The present invention contemplates treating retinitis pigmentosa by instilling or disposing one or more neurotrophic factors in the intraocular space.
All patents, published patent applications and other references disclosed herein are hereby expressly incorporated by reference in their entireties by reference. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents of the specific embodiments of the invention described herein. Such equivalents are intended to be encompassed by the following claims.
NUMERAL REFERENCES 1 superficial layer
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