Sub-retinal tangential needle catheter guide and introducer

Abstract

An apparatus includes a body, a needle, a catheter, and an actuator assembly. The needle extends distally from the body. The needle has an inner wall defining a needle lumen. The needle lumen is in fluid communication with a fluid port of the body. The catheter is slidably disposed in the needle lumen. The catheter has a catheter lumen. The first actuator assembly is configured to translate the catheter within and relative to the needle. The apparatus may also include an actuator assembly that is configured to rotate the needle relative to the body. The apparatus may be used to first deliver a leading bleb of fluid to the subretinal space in a patient's eye via the needle. The apparatus may then be used to deliver a therapeutic agent to the subretinal space in the patient's eye via the catheter.

1 - 20 . (canceled) 
     
     
         21 . An apparatus, comprising:
 (a) a body;   (b) an outer cannula extending distally from the body along a longitudinal axis, wherein the outer cannula is fixedly secured to the body;   (c) an inner cannula extending along the longitudinal axis and slidably disposed in the outer cannula for translating longitudinally relative to the outer cannula, wherein the inner cannula includes:
 (i) an open proximal end, 
 (ii) an open distal end, and 
 (iii) a lumen extending between the open proximal end and the open distal end, wherein the lumen is configured to communicate at least one fluid from the open proximal end to the open distal end for delivering the at least one fluid into a subretinal region of an eye of a patient; 
   (d) a sled slidably disposed within a bore of the body, wherein the sled is operable to translate longitudinally within the bore between a proximal longitudinal position and a distal longitudinal position, wherein the inner cannula is fixedly secured to the sled such that the inner cannula is configured to translate longitudinally together with the sled relative to the outer cannula; and   (e) at least one rotatable member configured to rotate about a rotation axis, wherein the rotation axis is perpendicular to the longitudinal axis, wherein the at least one rotatable member is operatively coupled to the sled such that rotation of the rotatable member causes longitudinal translation of the sled between the proximal longitudinal position and the distal longitudinal position.   
     
     
         22 . The apparatus of  claim 21 , wherein the open distal end of the inner cannula is configured to be retracted within the outer cannula when the sled is in the proximal longitudinal position. 
     
     
         23 . The apparatus of  claim 21 , wherein the open distal end of the inner cannula is configured to be extended distally out of the outer cannula when the sled is in the distal longitudinal position. 
     
     
         24 . The apparatus of  claim 21 , wherein the body includes an upper slot, wherein the at least one rotatable member is partially exposed relative to the body through the upper slot. 
     
     
         25 . The apparatus of  claim 21 , wherein the outer cannula includes an inner surface, and wherein the inner cannula includes an outer surface spaced apart from the inner surface of the outer cannula to define a gap between the inner surface of the outer cannula and the outer surface of the inner cannula. 
     
     
         26 . The apparatus of  claim 21 , wherein the sled includes a bore, wherein the inner cannula is securely received within the bore of the sled. 
     
     
         27 . The apparatus of  claim 21 , wherein the at least one rotatable member is operatively coupled to the sled such that rotation of the rotatable member in a first angular direction causes longitudinal translation of the sled in a distal direction, and such that rotation of the rotatable member in a second angular direction causes longitudinal translation of the sled in a proximal direction. 
     
     
         28 . The apparatus of  claim 21 , further comprising at least one pin configured to limit movement of the sled within the bore. 
     
     
         29 . The apparatus of  claim 28 , wherein the body includes the at least one pin. 
     
     
         30 . The apparatus of  claim 21 , wherein at least a portion of the outer cannula is generally straight. 
     
     
         31 . The apparatus of  claim 21 , further comprising at least one fluid source configured to be fluidly coupled with the inner cannula for supplying the at least one fluid to the open proximal end of the inner cannula. 
     
     
         32 . The apparatus of  claim 31 , wherein the body includes a proximal opening configured to facilitate coupling of the inner cannula with the at least one fluid source. 
     
     
         33 . The apparatus of  claim 31 , wherein the at least one fluid includes a therapeutic agent. 
     
     
         34 . The apparatus of  claim 21 , wherein the inner cannula is flexible. 
     
     
         35 . The apparatus of  claim 21 , wherein the inner cannula is flexible enough to conform to specific structures and contours of the patient's eye, yet has sufficient column strength to permit advancement of the inner cannula between a choroid and a retina of the eye without buckling. 
     
     
         36 . An apparatus, comprising:
 (a) a body;   (b) an outer cannula extending distally from the body along a longitudinal axis, wherein the outer cannula is fixedly secured to the body;   (c) an inner cannula extending along the longitudinal axis and slidably disposed in the outer cannula for translating longitudinally relative to the outer cannula, wherein the inner cannula includes:
 (i) an open proximal end, 
 (ii) an open distal end, and 
 (iii) a lumen extending between the open proximal end and the open distal end, wherein the lumen is configured to communicate at least one fluid from the open proximal end to the open distal end for delivering the at least one fluid into a subretinal region of an eye of a patient; and 
   (d) a sled slidably disposed within a bore of the body, wherein the sled is operable to translate longitudinally within the bore between a proximal longitudinal position and a distal longitudinal position, wherein the inner cannula is fixedly secured to the sled such that the inner cannula is configured to translate longitudinally together with the sled relative to the outer cannula, wherein the open distal end of the inner cannula is configured to be retracted within the outer cannula when the sled is in the proximal longitudinal position, and wherein the open distal end of the inner cannula is configured to be extended distally out of the outer cannula when the sled is in the distal longitudinal position.   
     
     
         37 . The apparatus of  claim 36 , further comprising an actuator configured to rotate about a rotation axis, wherein the actuator is operatively coupled to the sled such that rotation of the actuator causes longitudinal translation of the sled between the proximal longitudinal position and the distal longitudinal position. 
     
     
         38 . The apparatus of  claim 37 , wherein the rotation axis is perpendicular to the longitudinal axis. 
     
     
         39 . A method, comprising:
 (a) inserting an outer cannula of an instrument into an anterior region of a patient's eye while an inner cannula of the instrument is retracted within the outer cannula, the outer cannula extending along a longitudinal axis;   (b) piercing at least one layer of the patient's eye with the instrument to thereby access a subretinal region of the patient's eye;   (c) rotating an actuator about a rotation axis perpendicular to the longitudinal axis to thereby translate the inner cannula relative to the outer cannula along the longitudinal axis such that an open distal end of the inner cannula is advanced into the subretinal region of the patient's eye; and   (d) supplying at least one fluid to a lumen of the inner cannula such that the at least one fluid is delivered to the subretinal region of the patient's eye via the open distal end of the inner cannula.   
     
     
         40 . The method of  claim 39 , further comprising advancing the open distal end of the inner cannula along the subretinal region of the patient's eye.