Delivery and Extraction Devices

Abstract

This invention provides a device for delivering substances such as medical implants and tissues. The device comprises a mandrel and a mandrel guide whereby substances are delivered by retracting the mandrel guide relative to the mandrel. Included among the various embodiments are devices specialized for delivering retinal pigment epithelial (RPE) cells or nanoplates containing RPE cells to the retina, devices with precise control of delivery, devices with specialized mandrels and/or nozzles, and multifunctional devices adapted to provide additional functions such as infusion and/or suction, illumination, and diathermy.

We claim: 
     
         1 . A device for implanting a substance comprising:
 (a) a delivery unit comprising:
 (i) a mandrel guide, wherein the mandrel guide has an open distal end suitable for discharging a substance loaded therein; 
 (ii) a longitudinally elongated mandrel disposed internally to the mandrel guide, whereby relative longitudinal movement of the mandrel through the mandrel guide towards the open distal end biases the loaded substance to move longitudinally towards the open end; and 
   (b) a delivery unit support providing support to the delivery unit, wherein at least one of the mandrel and the mandrel guide is not fixed the delivery unit to allow longitudinal movement there about;   (c) a delivery unit biasing member imparting a force on the delivery unit to bias the delivery unit for the relative longitudinal movement;   (d) a delivery unit engagement means for opposing said force on the delivery unit when the delivery unit engagement means is engaged with the delivery unit, wherein the relative longitudinal movement is prevented when the delivery unit engagement means is engaged with the delivery unit;   (e) a delivery controller configured to engage and disengage the delivery unit engagement means from the delivery unit;   optionally, wherein the delivery unit support is a handpiece; and   optionally, wherein the device is configured for implanting a substance into an eye.   
     
     
         2 . The device of  claim 1 , wherein the longitudinally elongated mandrel is a conductive mandrel comprising:
 (a) at least a first distal port positioned at the distal end;   (b) at least a first proximal port positioned proximal to the at least first distal port; and   (c) a conductive member linking the at least first distal port and the at least first proximal port, wherein the conductive member is configured to conduct one or more of a fluid and a wave between the at least first distal port and the at least first proximal port;   
       optionally, wherein the at least first proximal port comprises an interface configured for linking the conductive mandrel to one or more of a fluid pump and a wave transmitter. 
     
     
         3 . The device of  claim 2 , wherein the conductive member comprises:
 (a) a fluid-conducting tube;   (b) an electrically conductive wire;   (c) a wave-transmitter;   (d) a fiber optic cable;   (e) a combination of (a) and (b);   (f) a combination of (a) and (c) or (a) and (d); or   (g) a combination of (a), (b), and (c) or of (a), (b), and (d).   
     
     
         4 . The device of  claim 2 , wherein the distal end of the conductive mandrel comprises a plurality of fluid-conducting tubes disposed laterally of each other at the distal end of the mandrel and a surface area-increasing member that increases the lateral surface area of the conductive mandrel. 
     
     
         5 . The device of  claim 1 , wherein the delivery controller comprises a toggle configured to interface a finger of a user thereof. 
     
     
         6 . The device of  claim 1 , wherein the delivery controller comprises an engagement biasing means for biasing the delivery unit engagement means to engage the delivery unit; whereby applying a user force to the delivery controller disengages delivery unit engagement means from the delivery unit to allow the relative longitudinal movement. 
     
     
         7 . The device  claim 6 , wherein the delivery controller comprises a toggle configured to interface a finger of a user thereof. 
     
     
         8 . The device of  claim 7 , wherein disengagement of the delivery unit engagement means requires less than about 3 lbs of force on the delivery controller from the user, optionally, wherein said less than about 3 lbs of force is:
 less than about 2 lbs of force, less than about 1 lb of force, or less than ¾ lb of force; or   about any of: 0.25 lb to 2 lb, 0.25 lb to 1 lb, or 0.25 lb to 0.75 lb; and about 200 g to about 500 g of force.   
     
     
         9 . The device of  claim 7 , further comprising a reversible safety mechanism configured to be engaged and disengaged by the user, wherein:
 when engaged, the safety mechanism opposes the bias of the delivery unit basing means, thereby preventing said relative longitudinal movement of the delivery unit irrespective of whether the delivery unit engagement means is engaged; and   when disengaged, the safety mechanism does not oppose the bias of the delivery unit basing means, thereby allowing said relative longitudinal movement of the delivery unit when the delivery unit engagement means is disengaged from the delivery unit; and   
       optionally, the reversible safety mechanism comprises:
 a pin fixed to the delivery unit and configured to move along a longitudinal path with the delivery unit, and 
 a latch disposed laterally of said longitudinal path, wherein the pin is configured to be movable into the latch, and thereby become longitudinally immobilized, wherein said relative longitudinal movement is prevented when the pin is longitudinally immobilized. 
 
     
     
         10 . The device of  claim 9 , wherein the delivery controller comprises an engagement biasing means for biasing the delivery unit engagement means to engage the delivery unit; whereby applying a user force to the delivery controller disengages delivery unit engagement means from the delivery unit to allow the relative longitudinal movement. 
     
     
         11 . The device of  claim 1 , wherein the delivery unit engagement means comprises a traction pad or a knife edge lock. 
     
     
         12 . The device of  claim 1 , wherein at least the distal portion of at least of one of the elongated mandrel and the mandrel guide are flexible or curved, optionally wherein said distal portion is flexible or curved enough to slide under the retina into the subretinal space when inserted through the pars plana of the eye. 
     
     
         13 . The device of  claim 1 , wherein the mandrel guide comprises a proximal length of guide and a nozzle coupled thereto, wherein the proximal length of guide comprises:
 a modular mandrel guide base; and   a nozzle holder, wherein:
 the modular mandrel guide base and the nozzle holder are reversibly coupled to each other; and 
 the nozzle holder is coupled to a nozzle or is configured to be coupled to a nozzle. 
   
     
     
         14 . The device of  claim 1 , wherein the nozzle is transparent. 
     
     
         15 . A device for implanting a substance comprising:
 (a) a delivery unit comprising:
 (i) a mandrel guide, wherein the mandrel guide has an open distal end for discharge of a substance loaded therein; and 
 (ii) a longitudinally elongated conductive mandrel disposed internally to the mandrel guide, whereby relative longitudinal movement of the mandrel through the mandrel guide towards the open distal end biases the loaded substance to move longitudinally towards the open end, wherein the conductive mandrel comprises an interface for conductively linking the conductive mandrel to a fluid pump or wave transmitter; and one or more distal ports, wherein the conductive mandrel is capable of conducting a fluid or wave between the fluid pump or wave transmitter and the environment at the one or more distal ports; 
   (b) a delivery unit support providing support to the delivery unit, wherein at least one of the mandrel and the mandrel guide is not fixed to the delivery unit to allow longitudinal movement there about; and   (c) a delivery controller operably linked to the delivery unit whereby operating the delivery controller imparts a force on the delivery unit to bias the delivery unit for the relative longitudinal movement.   
     
     
         16 . The device of  claim 15 , wherein the delivery unit support comprises a handpiece. 
     
     
         17 . The device of  claim 15 , wherein:
 the interface is disposed at the proximal end of the conductive mandrel; or the interface is disposed proximal to the open distal end.   
     
     
         18 . The device of  claim 15 , wherein the distal end of the conductive mandrel comprises a surface area-increasing member that increases the lateral surface area of the conductive mandrel. 
     
     
         19 . The device of  claim 15 , wherein the distal end of the conductive mandrel comprises a plurality of conductive members, optionally disposed laterally of each other at the distal end of the mandrel. 
     
     
         20 . A method of delivering cells to the subretinal space of a patient's eye, the method comprising:
 (a) loading the cells into the mandrel guide of a device of  claim 1 ;   (b) inserting the mandrel guide through the surface of the eye;   (c) orienting the open end of the mandrel guide in proximity to the retina;   (d) sliding the open end of the mandrel guide under the retina and into the subretinal space; and   (e) discharging the cells by retracting the mandrel guide relative to the Mandrel,   optionally wherein the cells are RPE cells.