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. 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 for treating a patient for spinal disorders, said method comprising:
 identifying a repair-needing area of cartilage in a spinal joint that comprises a first vertebra and a second vertebra and a spinal disc therebetween;   creating within said first vertebra a pathway to a bone-cartilage interface near said repair-needing area in said spinal joint; and   delivering a first therapeutic material, through said pathway, sufficiently close to said bone-cartilage interface so that said method is effective to relieve pain,   wherein said method comprises advancing a delivery device to a location within said first vertebra such that a distal end of said delivery device is located close to or at said bone-cartilage interface of said cartilage in said repair-needing area, and wherein said delivering said first therapeutic material comprises delivering said first therapeutic material through said delivery device.   
     
     
         2 . The method of  claim 1 , wherein said first therapeutic material comprises platelet-rich plasma. 
     
     
         3 . The method of  claim 1 , wherein said first therapeutic material comprises a granulocyte colony-stimulating factor. 
     
     
         4 . The method of  claim 1 , wherein said first therapeutic material comprises a granulocyte colony-stimulating factor, and wherein said delivering said first therapeutic material comprising said granulocyte colony-stimulating factor is followed by obtaining blood from said patient and producing platelet rich plasma from said blood and delivering said platelet rich plasma through said delivery device. 
     
     
         5 . The method of  claim 1 , further comprising delivering a clot-forming substance through said delivery device. 
     
     
         6 . The method of  claim 5 , wherein said clot-forming substance is selected from the group consisting of: a calcium chloride solution; and thrombin. 
     
     
         7 . The method of  claim 1 , wherein said location is such that said distal end of said delivery device is close to an interior edge of cortical bone and some other portion of said delivery device is located in or passes through cancellous bone. 
     
     
         8 . The method of  claim 1 , wherein said delivery device is externally threaded and said advancing comprises rotating said delivery device about a longitudinal axis of said delivery device. 
     
     
         9 . The method of  claim 1 , further comprising, after said advancing said delivery device but before said delivering of said first therapeutic material, partially retracting said delivery device so as to create an empty space for receiving said first therapeutic material, and delivering an amount of said first therapeutic material, and optionally repeating said retracting and said delivering. 
     
     
         10 . The method of  claim 1 , wherein said delivery device has at least one side port at or near a distal end thereof, such that said first therapeutic material can exit from said delivery device through said side port. 
     
     
         11 . The method of  claim 1 , wherein said introducing said delivery device is performed using imaging guidance, wherein said imaging guidance is selected from the group consisting of fluoroscopy and ultrasound guidance. 
     
     
         12 . The method of  claim 1 , further comprising performing said identifying step, said creating step, and said delivering said first therapeutic material step, on said second vertebra. 
     
     
         13 . The method of  claim 1 , further comprising delivering, at any time during said method, a second therapeutic material into said spinal disc between said first and second vertebrae. 
     
     
         14 . The method of  claim 13 , wherein said first therapeutic material and said second therapeutic material are identical to each other. 
     
     
         15 . The method of  claim 13 , wherein said delivering said second therapeutic material comprises delivering said second therapeutic material therapeutic simultaneously to a nucleus and an annulus of said spinal disc. 
     
     
         16 . The method of  claim 13 , wherein said delivering said second therapeutic material is performed using a device that comprises an outer needle and a longer inner needle suitable for introducing said second therapeutic material therethrough. 
     
     
         17 . The method of  claim 13 , wherein said delivering said second therapeutic material is performed using a device that comprises a puncturable septum that separates air inside said device from air outside said device. 
     
     
         18 . A method for treating a patient, said method comprising:
 identifying a repair-needing area of cartilage in a joint that comprises a first bone and a second bone;   creating within said first bone a pathway to a bone-cartilage interface near said repair-needing area in said first bone; and   delivering a first therapeutic material, through said pathway, sufficiently close to said bone-cartilage interface so that said method is effective to relieve pain,   wherein said method comprises advancing a delivery device to a location within said first bone such that a distal end of said delivery device is located close to or at said bone-cartilage interface of said cartilage in said repair-needing area, and wherein said delivering said first therapeutic material comprises delivering said first therapeutic material through said delivery device,   wherein said first therapeutic material comprises a Granulocyte Colony-Stimulating Factor.   
     
     
         19 . The method of  claim 18 , further comprising, after said delivering said first therapeutic material, obtaining blood from said patient, concentrating said obtained blood to form platelet rich plasma, and delivering said platelet rich plasma through said delivery device. 
     
     
         20 . The method of  claim 18 , wherein said first bone is a first vertebra and said second bone is a second vertebra, said first vertebra and said second vertebra being separated from each other by a spinal disc, and further comprising delivering, at any time during said method, a second therapeutic material into said spinal disc between said first and second vertebrae.