Device for ocular access

Abstract

The present invention provides devices to access the suprachoroidal space or sub-retinal space in an eye via a minimally invasive transconjunctival approach. The devices may also be used after a partial dissection, for example after dissection of the outer scleral layer of the eye, and using the device within the dissection to access the suprachoroidal space or the sub-retinal space.

1 . A device comprising an elongated body having a distal end and proximal end, said ends in communication through an internal pathway within said body wherein:
 a. said distal end is configured with a sharp edge or point to penetrate into ocular tissues of the outer shell of the eye,   b. a moveable guarding element disposed in a first configuration to shield said ocular tissues from said sharp edge or point, and adapted to apply a distally directed force to said tissues at the distal end of the device to displace tissue away from the distal end of the device upon entry into the suprachoroidal space or subretinal space in an eye with said distal end; wherein said guarding element is moveable to a second configuration to expose said sharp edge or point to said tissues for penetration into said tissues   c. and an access port to deliver materials and substances through said pathway in the elongated body after deployment of the guarding element within the suprachoroidal space or subretinal space.   
     
     
         2 . The device of  claim 1  wherein the guarding element is attached to a spring or compressible element that upon compression thereof provides a distally directed force on the guarding element. 
     
     
         3 . The device of  claim 2  wherein the distally directed force is in the range of about 1 to 5 grams force. 
     
     
         4 . The device of  claim 1  wherein the guarding element comprises a flowable material selected from a fluid or gas that is directed to flow out the of the distal end of the device to provide a distally directed force. 
     
     
         5 . The device of  claim 4  where the flowable material provides distally directed force with a pressure in the range of about 0.5 to 52 mm Hg. 
     
     
         6 . The device of  claim 2  or  4  wherein said elongated body comprises a metal tube selected from stainless steel, nitinol, titanium or tungsten. 
     
     
         7 . The device of  claim 2  or  4  wherein said elongated body comprises a plastic tube selected from polyimide, polyamide, polyetheretherketone, or polycarbonate. 
     
     
         8 . The device of  claim 1  wherein said distal end comprises a beveled tip. 
     
     
         9 . The device of  claim 8  wherein said bevels are in the range of about 8 to 30 degrees. 
     
     
         10 . The device of  claim 1  wherein said distal end incorporates a bent or angled segment having a bend angle in the range of about 10 to 60 degrees. 
     
     
         11 . The device of  claim 1  wherein said proximal end is adapted to receive a delivery element. 
     
     
         12 . The device of  claim 11  wherein said proximal end is adapted to receive a Luer connector. 
     
     
         13 . The device of  claim 11  wherein said delivery element comprises a syringe. 
     
     
         14 . The device of  claim 1  wherein said proximal end comprises a reservoir for receiving a material to be delivered to the target space. 
     
     
         15 . The device of  claim 14  wherein said reservoir is adapted to connect a delivery element. 
     
     
         16 . The device of  claim 14  wherein said delivery element comprises a syringe. 
     
     
         17 . The device  claim 15  wherein said reservoir is adapted with a Luer connector. 
     
     
         18 . The device of  claim 15  wherein said reservoir is adapted with an injection septum. 
     
     
         19 . The device of  claim 14  wherein said reservoir incorporates a one-way valve to allow for filling and pressurization of the reservoir. 
     
     
         20 . A device for placement in the sclera of an eye, comprising a body having a proximal end adapted for location at or near the scleral surface and a distal end adapted for location within the suprachoroidal or subretinal space, where said device comprises a lumen and a mechanical stop at the proximal end for retaining the proximal end at or near the scleral surface. 
     
     
         21 . The device according to  claim 20  wherein said mechanical stop is provided by said proximal end having a larger diameter than the diameter of said distal end. 
     
     
         22 . The device according to  claim 20  wherein said mechanical stop comprises a flange. 
     
     
         23 . The device according to  claim 20  wherein said body has a maximum diameter of about 0.071 to 0.89 mm. 
     
     
         24 . The device according to  claim 20  wherein said body has a length of about 1.5 to 5 mm. 
     
     
         25 . The device according to  claim 4  further comprising a sealing element attached at the distal end of said elongated body adapted to reduce or prevent leakage of fluid or gas through a tissue tract created by the device. 
     
     
         26 . The device according to  claim 25  wherein said device accommodates a spring to apply a distal force on said sealing element to provide a sealing force of said element against the eye tissue. 
     
     
         27 . The device according to  claim 25  wherein said device comprises a reservoir at the proximal end for receiving a material to be delivered at the target space and said sealing element is in mechanical communication with and activating element for releasing said material from said reservoir. 
     
     
         28 . The device according to  claim 1  further comprising an associated sealing element adapted for retention on the surface of the eye to receive the distal end of said to locate and stabilize said device during penetration into the eye. 
     
     
         29 . A method for accessing the suprachoroidal space of an eye comprising inserting the device according to  claim 1  through tissue in an eye to access the suprachoroidal space in the eye with said distal end. 
     
     
         30 . A method for accessing the subretinal space of an eye comprising inserting the device according to  claim 1  through tissue in an eye to access the subretinal space in the eye with said distal end. 
     
     
         31 . A method for placing a port into a scleral tract in an eye comprising inserting the device according to  claim 20  through tissue in an eye and emplacing said distal end within the suprachoroidal space or subretinal space in the eye with said proximal end at or near the scleral surface. 
     
     
         32 . A method for accessing the suprachoroidal space of an eye comprising inserting the device according to  claim 25  through tissue in an eye to access the suprachoroidal space in the eye with said distal end. 
     
     
         33 . A method for accessing the subretinal space of an eye comprising inserting the device according to  claim 25  through tissue in an eye to access the subretinal space in the eye with said distal end. 
     
     
         34 . A method for accessing the suprachoroidal space of an eye comprising inserting the device according to  claim 28  through said associated sealing element and tissue in an eye to access the suprachoroidal space in the eye with said distal end. 
     
     
         35 . A method for accessing the subretinal space of an eye comprising inserting the device according to  claim 28  through said associated sealing element and tissue in an eye to access the subretinal space in the eye with said distal end.