Devices and methods for the treatment of spinal disorders

Abstract

Devices and methods for treating a damaged intervertebral disc to reduce or eliminate associated back pain. Dynamic bias devices and reinforcement devices are disclosed, which may be used individually or in combination, to eliminate nerve impingement associated with the damaged disc, and/or to reinforce the damaged disc, while permitting relative movement of the vertebrae adjacent the damaged disc.

1 . A method of treating an intervertebral disc having an annulus and a nucleus, comprising:
 providing a first elongate tubular member having a proximal end, a tissue penetrating distal end and a lumen extending therethrough;   inserting the distal end of the first member into the disc;   providing a second elongate tubular member having a proximal end, a resiliently curved distal end and a lumen extending therethrough;   inserting the second member into the lumen of the first member such that the distal end of the second member extends distally of the distal end of the first elongate member; and   implanting a device in the disc via an insertion path defined at least in part by the first and second elongate members.   
   
   
       2 . A method as in  claim 1 , wherein the implanted device is implanted in the disc via the lumen of the second member. 
   
   
       3 . A method as in  claim 1 , wherein the implanted device is implanted in the annulus. 
   
   
       4 . A method as in  claim 1 , wherein the implanted device is expandable. 
   
   
       5 . A method as in  claim 4 , wherein the implanted device is delivered in an unexpanded state. 
   
   
       6 . A method as in  claim 5 , wherein the implanted device is inflatable. 
   
   
       7 . A method as in  claim 5 , wherein the implanted device is self-expandable. 
   
   
       8 . A method as in  claim 7 , wherein the implanted device expands by hydration. 
   
   
       9 . A method as in  claim 8 , wherein the implanted device comprises a hydrophilic material. 
   
   
       10 . A method as in  claim 1 , wherein the implanted device comprises a metallic material. 
   
   
       11 . A method as in  claim 10 , wherein the implanted device comprises stainless steel. 
   
   
       12 . A method as in  claim 10 , wherein the implanted device comprises a super-elastic alloy. 
   
   
       13 . A method as in  claim 10 , wherein the implanted device comprises a nickel titanium alloy. 
   
   
       14 . A method as in  claim 10 , wherein the implanted device comprises a MP35N alloy. 
   
   
       15 . A method as in clam  1 , wherein the second member is inserted into the lumen of the first member such that the distal end of the second member extends distally of the distal end of the first elongate member and points in a direction generally aligned with an anterior or posterior curvature of the annulus. 
   
   
       16 . A method as in  claim 1 , wherein the distal end of the second member is configured to penetrate tissue. 
   
   
       17 . A method as in  claim 16 , wherein the second member includes a shaft portion and a sharpened distal tip. 
   
   
       18 . A method as in  claim 17 , wherein the shaft potion of the second member comprises a polymer. 
   
   
       19 . A method as in  claim 17 , wherein the shaft portion of the second member comprises a composite. 
   
   
       20 . A method as in  claim 1 , wherein the second member is longer than the first member. 
   
   
       21 . A method as in  claim 1 , wherein the curved distal end of the second member straightens upon insertion into the first elongate member. 
   
   
       22 . A method as in  claim 21 , wherein the first member comprises a rigid material. 
   
   
       23 . A method as in  claim 22 , wherein the first member comprises a metal. 
   
   
       24 . A method as in  claim 22 , further comprising:
 providing a third elongate member having a proximal end and a distal end; and inserting the third member into the second member.   
   
   
       25 . A method as in  claim 24 , wherein the distal end of the third member extends beyond the distal end of the second member. 
   
   
       26 . A method as in  claim 25 , wherein the distal end of the third member is configured to penetrate tissue, and wherein the tissue penetrating distal end of the third member extends into disc tissue. 
   
   
       27 . A method as in  claim 26 , wherein the third member includes a flexible shaft portion and a sharpened distal tip. 
   
   
       28 . A method as in  claim 24 , wherein the third member comprises a push rod. 
   
   
       29 . A method as in  claim 28 , wherein the implanted device is pushed out the distal end of the second member using the push rod. 
   
   
       30 . A method of treating an intervertebral disc having an annulus and a nucleus, comprising:
 providing a first elongate tubular member having a proximal end, a tissue penetrating distal end and a lumen extending therethrough;   inserting the distal end of the first member into the annulus;   providing a second elongate tubular member having a proximal end, a curved tissue penetrating distal end and a lumen extending therethrough;   inserting the second member into the lumen of the first member such that the distal end of the second member extends distally of the distal end of the first elongate member; and   implanting a device in the disc via an insertion path defined at least in part by the first and second elongate members.   
   
   
       31 . A method as in  claim 30 , wherein the implanted device is planted in the disc via the lumen of the second member. 
   
   
       32 . A method as in  claim 30 , wherein the implanted device is implanted in the annulus. 
   
   
       33 . A method as in  claim 30 , wherein the implanted device is expandable. 
   
   
       34 . A method as in  claim 33 , wherein the implanted device is delivered in an unexpanded state. 
   
   
       35 . A method as in  claim 34 , wherein the implanted device is inflatable. 
   
   
       36 . A method as in  claim 34 , wherein the implanted device is self-expandable. 
   
   
       37 . A method as in  claim 36 , wherein the implanted device expands by hydration. 
   
   
       38 . A method as in  claim 37 , wherein the implanted device comprises a hydrophilic material. 
   
   
       39 . A method as in  claim 30 , wherein the implanted device comprises a metallic material. 
   
   
       40 . A method as in  claim 39 , wherein the implanted device comprises stainless steel. 
   
   
       41 . A method as in  claim 39 , wherein the implanted device comprises a super-elastic alloy. 
   
   
       42 . A method as in  claim 39 , wherein the implanted device comprises a nickel titanium alloy. 
   
   
       43 . A method as in  claim 39 , wherein the implanted device comprises a MP35N alloy. 
   
   
       44 . A method as in  claim 30 , wherein the second member is inserted into the lumen of the first member such that the distal end of the second member extends distally of the distal end of the first elongate member and points in a direction generally aligned with an anterior or posterior curvature of the annulus. 
   
   
       45 . A method as in  claim 30 , wherein the curved distal end of the second member is resilient. 
   
   
       46 . A method as in  claim 45 , wherein the curved distal end of the second member straightens upon insertion into the first elongate member. 
   
   
       47 . A method as in  claim 46 , wherein the first member comprises a rigid material. 
   
   
       48 . A method as in  claim 47 , wherein the first member comprises a metal. 
   
   
       49 . A method as in  claim 30 , wherein the second member includes a shaft portion and a sharpened distal tip. 
   
   
       50 . A method as in  claim 49 , wherein the shaft portion of the second member comprises a polymer. 
   
   
       51 . A method as in  claim 49 , wherein the shaft portion of the second member comprises a composite. 
   
   
       52 . A method as in  claim 30 , wherein the second member is longer than the first member. 
   
   
       53 . A method as in  claim 30 , further comprising:
 providing a third elongate member having a proximal end and a distal end; and inserting the third member into the second member.   
   
   
       54 . A method as in  claim 53 , wherein the distal end of the third member extends beyond the distal end of the second member. 
   
   
       55 . A method as in  claim 54 , wherein the distal end of the third member is configured to penetrate tissue, and wherein the tissue penetrating distal end of the third member extends into disc tissue. 
   
   
       56 . A method as in  claim 55 , wherein the third member includes a flexible shaft portion and a sharpened distal tip. 
   
   
       57 . A method as in  claim 53 , wherein the third member comprises a push rod. 
   
   
       58 . A method as in  claim 57 , wherein the implanted device is pushed out the distal end of the second member using the push rod. 
   
   
       59 . A method as in  claim 58 , wherein the implanted device is self-expanding. 
   
   
       60 . A method of treating an intervertebral disc having an annulus and a nucleus, comprising:
 providing a tubular member having a proximal end, a distal end and a lumen extending therethrough;   inserting the distal end of the tubular member into the disc;   providing an elongate stylet having a proximal end and a tissue penetrating distal end;   inserting the stylet through the tubular member and into the disc;   providing a device having a lumen configured to accommodate the stylet; and advancing the device over the stylet and into the disc.   
   
   
       61 . A method as in  claim 60 , wherein the distal end of the tubular member is curved. 
   
   
       62 . A method as in  claim 61 , wherein the curved distal end is resilient. 
   
   
       63 . A method as in  claim 60 , wherein the distal end of the tubular member is configured to penetrate tissue. 
   
   
       64 . A method as in  claim 63 , wherein the distal end of the tubular member includes a sharpened tip. 
   
   
       65 . A method as in  claim 60 , wherein the stylet includes a flexible shaft portion. 
   
   
       66 . A method as in  claim 65 , wherein the flexible shaft portion comprises a metallic material. 
   
   
       67 . A method as in  claim 66 , wherein the metallic material comprises stainless steel. 
   
   
       68 . A method as in  claim 66 , wherein the metallic material comprises a nickel titanium alloy. 
   
   
       69 . A method as in  claim 66 , wherein the metallic material comprises a MP35N alloy. 
   
   
       70 . A method as in  claim 60 , wherein the stylet has a length of about 10 cm to 60 cm.