Delivery system for delivering a drug depot to a target site under image guidance and methods and uses of same

Abstract

A delivery system for delivering a drug depot to a site within a patient, the system comprising: a cannula; a delivery stylet configured and dimensioned to be receivable by and slidable forwardly and backwardly within the cannula including to a position wherein a distal portion of the stylet protrudes beyond the distal end of the cannula; a drug depot retainable by the stylet at the distal end of the stylet, the drug depot being visualizable by a diagnostic imaging beam or modality; and an actuator for ejecting the drug depot from the stylet to a site within the body using fluid pressure. Also disclosed are methods using, and uses of, the delivery system, including for treating scoliosis.

1 . A delivery system for delivering a drug depot to a site within a patient, the system comprising:
 a. a hollow cannula having a proximal end and a distal end;   b. a delivery stylet having a proximal end, a distal end, a lumen extending between the proximal and distal ends of the delivery stylet, and a distal portion at the distal end of the delivery stylet, the delivery stylet being configured and dimensioned to be receivable by and slidable forwardly and backwardly within the cannula including to a position wherein said distal portion protrudes beyond the distal end of the cannula; and   c. an actuator for ejecting the drug depot from the stylet to a site within the body, said actuator having a fluid delivery mechanism in fluid communication with an interior of the stylet and being effective to create pressure within the stylet sufficient to eject the drug depot therefrom.   
     
     
         2 . The delivery system of  claim 1 , further comprising a drug depot retained by the stylet at the distal end of the stylet, the drug depot being visualizable by a diagnostic imaging beam or modality. 
     
     
         3 . The delivery system of  claim 2 , wherein the drug depot has a portion inside the stylet and a portion protruding from the distal end of the stylet. 
     
     
         4 . The delivery system of  claim 2 , further comprising a solid stylet configured and dimensioned to be receivable inside the cannula to provide rigidity thereto, whereby the cannula, with the solid stylet received therein, is effective to pierce tissue of a patient. 
     
     
         5 . The delivery system of  claim 1 , wherein the drug depot comprises a radiographic marker that allows the drug depot to be visualized under a diagnostic imaging beam. 
     
     
         6 . The delivery system of  claim 5 , wherein the radiographic marker is selected from the group consisting of barium, calcium phosphate, bismuth, iodine, tantalum, tungsten, metal beads, and mixtures thereof. 
     
     
         7 . The delivery system of  claim 1 , wherein the delivery stylet has a hub at the proximal end thereof, and the actuator is releasably attachable to the hub. 
     
     
         8 . The delivery system of  claim 7 , wherein the actuator is a syringe having a barrel, a plunger slidable within the barrel, and wherein the barrel has a distal portion configured to be attachable to the hub of the delivery stylet. 
     
     
         9 . The delivery system of  claim 8 , wherein the syringe is a Luer lock syringe and the hub of the delivery stylet has external threads complementary to internal threads of the Luer lock of the syringe. 
     
     
         10 . The delivery system of  claim 1 , wherein the fluid is a liquid. 
     
     
         11 . The delivery system of  claim 10 , wherein the liquid comprises an agent selected from the group consisting of an anaesthetic, Depo-Medrol (methylprednisolone), dexamethasone, and mixtures thereof. 
     
     
         12 . The delivery system  claim 2 , wherein the diagnostic imaging beam or modality is selected from the group consisting of computed tomography (CT), ultrasound, x-ray, magnetic resonance imaging (MRI), and fluoroscopy. 
     
     
         13 . The delivery system of  claim 1 , wherein at least one of the cannula and delivery stylet comprises a radiopaque material or ultrasound responsive topography to provide increased contrast relative to the absence of the material or topography under a diagnostic imaging beam. 
     
     
         14 . The delivery system of  claim 1  for use in treating scoliosis. 
     
     
         15 . A method of delivering a drug depot to a site within a patient, the method comprising:
 a. inserting a cannula with a solid stylet received into a target tissue of a patient under image guidance;   b. removing the solid stylet from the cannula and inserting a delivery stylet into the cannula until a distal portion of the delivery stylet emerges from a distal end of the cannula; c. positioning a drug depot under image guidance by moving the delivery stylet forwards and/or backwards until the drug depot is positioned at a desired location; and   d. actuating an actuator to expel the drug depot from the delivery stylet.   
     
     
         16 . The method of  claim 15  for treating scoliosis, comprising delivering a drug depot comprising a therapeutically acceptable amount of a growth modulator into a first epiphyseal growth plate of a first vertebra for altering the growth of the first epiphyseal growth plate to correct or compensate for disproportionate growth. 
     
     
         17 . Use of the delivery system according to  claim 1  to treat scoliosis.