Apparatus and method for surgical bypass of aqueous humor

Abstract

The invention provides minimally invasive microsurgical tools and methods to form an aqueous humor shunt or bypass for the treatment of glaucoma. The invention enables surgical creation of a tissue tract ( 7 ) within the tissues of the eye to directly connect a source of aqueous humor such as the anterior chamber ( 1 ), to an ocular vein ( 4 ). The tissue tract ( 7 ) from the vein ( 4 ) may be connected to any source of aqueous humor, including the anterior chamber ( 1 ) ), an aqueous collector channel, Schlemm's canal ( 2 ), or a drainage bleb. Since the aqueous humor passes directly into the venous system, the normal drainage process for aqueous humor is restored. Furthermore, the invention discloses devices and materials that can be implanted in the tissue tract to maintain the tissue space and fluid flow.

1 . An apparatus for creating a tract within the scleral tissues of an eye comprising:
 an elongated body portion shaped to create said tract wherein said tract forms a path for flow of aqueous humor into an ocular vein.   
   
   
       2 . The apparatus of  claim 1  wherein said body portion comprises a proximal end and distal end. 
   
   
       3 . The apparatus of  claim 2  wherein said body portion has an outer diameter in the range of 50 to 500 microns. 
   
   
       4 . The apparatus of  claim 2  wherein said body portion comprises a flexible microcannula. 
   
   
       5 . The apparatus of  claim 2  wherein said distal end comprises a mechanical cutting tip. 
   
   
       6 . The apparatus of  claim 2  where in said distal end comprises an energy source to ablate tissue. 
   
   
       7 . The apparatus of  claim 6  wherein said energy comprises laser light, radio frequency energy, or thermal energy. 
   
   
       8 . The apparatus of  claim 2  where said distal end is visible by medical imaging. 
   
   
       9 . The apparatus of  claim 8  wherein medical imaging comprises ultrasound or optical coherence tomography. 
   
   
       10 . The apparatus of  claim 2  wherein said distal end comprises an optical beacon visible under direct observation through scleral tissues. 
   
   
       11 . The apparatus of  claim 2  wherein said body portion comprises an outer sheath and an inner member. 
   
   
       12 . The apparatus of  claim 11  wherein said inner member is removable during use from said outer sheath. 
   
   
       13 . The apparatus of  claim 1  which additionally comprises a space maintaining material placeable within said tract. 
   
   
       14 . The apparatus of  claim 13  wherein said space maintaining material comprises hyaluronic acid. 
   
   
       15 . The apparatus of  claim 13  wherein said space maintaining material comprises a cellular proliferation inhibitor. 
   
   
       16 . The apparatus of  claim 15 , wherein said cellular proliferation inhibitor comprises methotrexate, paclitaxel, or sirolimus. 
   
   
       17 . The apparatus of  claim 13 , wherein said space maintaining material comprises an anti-thrombotic agent. 
   
   
       18 . The apparatus of  claim 17  wherein said anti-thrombotic agent comprises heparin or tissue plasminogen activator. 
   
   
       19 . The apparatus of  claim 13  wherein said material comprises a stent device. 
   
   
       20 . The apparatus of  claim 19  wherein said device comprises hyaluronic acid. 
   
   
       21 . The apparatus of  claim 19  wherein said device comprises a nickel titanium alloy. 
   
   
       22 . The apparatus of  claim 19  wherein said device is changeable in situ from a first configuration to a second configuration. 
   
   
       23 - 30 . (canceled)