Cartilage repair, preservation and growth by stimulation of bone-chondral interface and delivery system and methods therefor

Abstract

Therapeutics and methods of treatment to repair, preserve and grow cartilage are presented. In addition, systems and methods for delivering a therapeutic to a hard to reach anatomical area, such as, for example, the BCI, are presented. A cannulated delivery device provided with a cutting tip, cutting flutes and threads on its distal end can be provided. Using such an exemplary device, various novel therapies for joint and cartilage repair, preservation and generation can be implemented. Alternatively, for disc repair, a delivery device directed to percutaneous intradiscal annular repair, or “PIARES” device can be used to introduce therapeutics intradiscally. The device may have two-needles, with a first cannula/needle, with a finger grip at its distal end, and a longer inner needle to penetrate through the outer needle into the disc, and introduce therapeutics, for example, via a syringe. When provided with a septum at the inner needle's proximal end, the PIARES device is a completely closed system, and its use minimizes trauma.

1 . A method of stimulating cartilage repair, preservation and growth in peripheral joints and spine, comprising:
 injecting a quantity of a granulocyte colony-stimulating factor (“GCSF”) on a first day;   drawing blood and spinning it down to obtain 4-12 cc—of Platelet Rich Plasma (“PRP”) in total;   injecting 1-3 cc of the PRP above the joint by drilling and injecting at the bone-cartilage interface, followed by injection of 0.1-0.3 cc of a clotting agent;   injecting 1-3 cc of the PRP below the joint by drilling and injecting at the bone-cartilage interface, followed by injection of 0.1-0.3 cc of a clotting agent; and   injecting the remaining 2-6 cc PRP into the joint.   
     
     
         2 . The method of  claim 1 , further comprising injecting a second quantity of a granulocyte colony-stimulating factor on a second day, prior to drawing blood to obtain PRP. 
     
     
         3 . The method of  claim 1 , wherein the peripheral joint is the knee, and wherein the PRP is injected into (i) one of the femoral medial and lateral compartment, and (ii) one of the femoral medial and lateral compartment. 
     
     
         4 . The method of  claim 2 , wherein the quantity of GCSF injected is 350 mcg. 
     
     
         5 . The method of  claim 4 , wherein following each injection of PRP followed by clotting agent, waiting 2-4 minutes for a cot to form prior to removing a delivery device used. 
     
     
         6 . A delivery device, comprising:
 a cannulated shaft comprising a tapered end provided with cutting flutes and a cutting tip, said shaft provided with one or more holes at its distal end;   a hub; and   a cap with twist grip,   wherein the cap is removable from the hub and cannulated shaft, and wherein in operation, by twisting the cap the shaft can be advanced through tissue so as to deliver a therapeutic or other preparation to a body part.   
     
     
         7 . The device of  claim 6 , the cap further comprising a surface at its proximal end for tapping with a hammer. 
     
     
         8 . The device of  claim 7 , wherein the cap and hub are connected via keys, which thus insure that the cap and hub do not move relative to one another as a user drills or screws in the device. 
     
     
         9 . The device of  claim 8 , wherein the top of the hub is provided with a septum, which allows a sterile syringe to be introduced into the cannula to inject therapeutics or PRP rich blood, after removing the cap, once the device is in position. 
     
     
         10 . The device of  claim 9 , wherein, in operation, a user first taps the cap with a hammer to initially set the device into place, and then subsequently twists the device via the grip to advance the delivery device into place. 
     
     
         11 . The device of  claim 10 , wherein the user first taps the cap with a hammer to initially set the device into place into dense cortical bone, and then subsequently twists the device via the grip to advance the delivery device into spongy bone. 
     
     
         12 . The device of  claim 7 , wherein the cannulated shaft is provided with threads on the outer surface of a portion of its distal end proximal to the cutting tip. 
     
     
         13 . The device of  claim 8 , wherein the top of the hub is provided with an impact cap. 
     
     
         14 . The device of  claim 13 , wherein the proximal end of the cap is provided with a tapping surface arranged, when removed and turned to face the hub, to hammer the device into a patient. 
     
     
         15 . A delivery device for percutaneous intradiscal annular repair, comprising:
 an outer needle;   a stylette that fits inside the outer needle and that has substantially the same length as said outer needle;   an inner needle, at least 20% longer than said outer needle.   
     
     
         16 . The delivery device of  claim 15 , wherein the inner needle is fitted with a finger grip and one of a luer lock hub and a septum at its proximal end. 
     
     
         17 . The delivery device of  claim 16 , wherein the inner needle is 21-25 gauge, and the outer needle 16 gauge. 
     
     
         18 . The delivery device of  claim 16 , wherein the inner needle is provided with a septum at its proximal end, and thus provides a completely closed system when inserted intradiscally. 
     
     
         19 . (canceled) 
     
     
         20 . The delivery device of  claim 15 , wherein in operation:
 a user first inserts the outer needle, with stylette inside;   the outer needle is placed near, but not all the way towards, the relevant disc; the stylette is then removed, and the inner needle inserted inside the outer needle; and   therapeutic is introduced via the inner needle.   
     
     
         21 . The delivery device of  claim 20 , wherein one of the outer needle and the inner and outer needles are introduced under imaging guidance. 
     
     
         22 . (canceled)