Apparatus for enhanced delivery of treatment device to the intervertebral disc annulus

Abstract

The present invention provides methods and devices for enhancing the delivery of treatment devices for treating the annulus of an intervertebral disc. The methods and devices may employ delivery support elements to delivery tools used to deliver expandable treatment devices to the intervertebral disc. Fixation devices and methods are also disclosed, which may help to secure the treatment device in place.

1 . A system for use in the treatment of intervertebral disc tissue comprising:
 a therapeutic device including a first end and a second end and an intermediate portion therebetween, the therapeutic device configured to transition from a first, pre-deployment configuration in which the intermediate portion has a radially compact configuration to a second, post-depoyment configuration in which the intermediate portion has a radially expanded configuration;   a delivery tool including a longitudinal shaft having a proximal end and a distal end carrying the therapeutic device releasably attached thereto, and at least one proximal actuating member; and   a delivery support element connected to the therapeutic device and to the delivery tool, the delivery support element movable in the longitudinal direction under tension to facilitate deployment of the therapeutic device from the first, pre-deployment configuration to the second, post-deployment configuration.   
     
     
         2 . The system of  claim 1 , wherein the delivery support element includes a suture line having a first end and a second end. 
     
     
         3 . The system of  claim 2 , wherein the first end and the second end of the suture line are attached to the proximal actuating member of the delivery tool. 
     
     
         4 . The system of  claim 2 , wherein the first end is attached to the proximal actuating member of the delivery tool, and the second end is attached to the proximal end of the delivery tool. 
     
     
         5 . The system of  claim 2 , wherein at least one proximal actuating member includes a first proximal actuating member and a second proximal actuating member, and wherein the first end of the suture line is attached to the first proximal actuating member and the second end of the suture line is attached to the second proximal actuating member. 
     
     
         6 . The system of  claim 2 , further comprising a finger grip assembly, wherein the proximal actuating member abuts the finger grip assembly, and wherein the second end of the suture line is releasably affixed to a juncture between the proximal actuating member and the finger grip assembly. 
     
     
         7 . The system of  claim 2 , wherein the suture line extends from the delivery tool and through the therapeutic device releasably attached to the distal end of the shaft of the delivery tool. 
     
     
         8 . The system of  claim 2 , wherein the second end of the suture line is releasable from the delivery tool. 
     
     
         9 . The system of  claim 1 , wherein the delivery support element is releasable from the delivery tool. 
     
     
         10 . The system of  claim 1 , wherein said at least one delivery support element is constructed from biocompatible polymeric materials, polyamide, polyamide derivatives, polyketones, polyketone derivatives, PET, polycarbonate, acrylic, polyurethane, polycarbonate urethane, acetates, acetate derivatives, polysulfones, polysulfone derivatives, biocompatible metallic materials, biodegradable/bioresorbable materials, naturally derived materials, or synthetically derived materials. 
     
     
         11 . The system of  claim 1 , further comprising a delivery support element collar configured to distally hold the delivery support element. 
     
     
         12 . The system of  claim 11  wherein the delivery support element collar is configured to allow the delivery support element to movably pass through the collar. 
     
     
         13 . The system of  claim 11 , wherein the delivery support element collar is affixed to the delivery tool. 
     
     
         14 . The system of  claim 11 , wherein the delivery support element collar is movable in the longitudinal direction. 
     
     
         15 . The system of  claim 11 , wherein the delivery support element collar comprises a tube affixed to the shaft of the delivery tool. 
     
     
         16 . The system of  claim 1 , wherein the delivery support element comprises a tether, a rod, beam, wire, band, tube, or actuating element. 
     
     
         17 . The system of  claim 1 , wherein the delivery support element comprises a suture line having at least one knot along its length. 
     
     
         18 . The system of  claim 1 , wherein the delivery support element is integrated with the therapeutic device. 
     
     
         19 . The system of  claim 1 , wherein at least a portion of the delivery support element is exterior to said delivery tool. 
     
     
         20 . The system of  claim 1 , wherein the distal end of the delivery tool shaft comprises a latching element. 
     
     
         21 . A system for use in the treatment of intervertebral disc tissue comprising:
 a therapeutic device including a first end and a second end and an intermediate portion therebetween, the therapeutic device configured to transition from a first, pre-deployment configuration in which the intermediate portion has a radially compact configuration to a second, post-depoyment configuration in which the intermediate portion has a radially expanded configuration;   a therapeutic device delivery tool including a longitudinal shaft having a proximal end and a distal end, an actuator rod configured to traverse at least a portion of the therapeutic device, a holding tube assembly having a distal end and a proximal end and slidably disposed within the shaft and sized to receive the actuator rod, the distal end of the holding tube assembly including a therapeutic device latch configured to releasably engage the therapeutic device, a finger grip member at least partially positioned within the shaft and abutting the distal end of the holding tube assembly, wherein the finger grip member is moveable in the longitudinal direction so that longitudinal movement by the finger grip member concomitantly moves the holding tube assembly in the longitudinal direction, and wherein the finger grip member comprises an orifice sized to receive the actuator rod; and   a delivery support element connected to the therapeutic device and to the delivery tool, the delivery support element movable in the longitudinal direction under tension to facilitate deployment of the therapeutic device from the first, pre-deployment configuration to the second, post-deployment configuration.   
     
     
         22 . The system of  claim 21 , further comprising a delivery support element collar configured to hold the delivery support element and located along said shaft. 
     
     
         23 . The system of  claim 21 , wherein the delivery support element is engaged with an actuating body assembly so that longitudinal movement of the finger grip member concomitantly translates the actuating body assembly, the holding tube assembly, and the delivery support element. 
     
     
         24 . The system of  claim 21 , wherein the delivery support element is a suture line having a first end and a second end. 
     
     
         25 . The system of  claim 24 , wherein the delivery support element is engaged with an actuating body assembly, and wherein the first end and the second end of the suture line are attached to the actuating body assembly. 
     
     
         26 . The system of  claim 24 , wherein the delivery support element is engaged with an actuating body assembly, and wherein the first end of the suture line is attached to the actuating body assembly and the second end of the suture line is attached to the shaft. 
     
     
         27 . The system of  claim 24 , wherein the at least one delivery support element is a tether, rod, beam, wire, band, tube, or actuating element.