Surgical spacer with shape control

Abstract

An interspinous spacer for placement between adjacent spinous processes includes a flexible, fillable container (e.g., a bag or balloon) for containing a material that is compressible during end use, for example, silicone after curing. The container is impermeable to the material it will be filled with. A structural mesh, for example, made of PET fabric and interwoven shape-memory alloy wire, provides structure for and containment of the container, as well as shape control. The material can be injected into the container through an optional conduit, for example, a one-way valve.

1 . A surgical spacer, comprising:
 a flexible container for containing a material that is compressible during end use, wherein the container is substantially impermeable to the material; and   a structure for at least part of the container when containing the material;   wherein the structure controls at least part of a shape of the surgical spacer.   
   
   
       2 . The surgical spacer of  claim 1 , wherein the material is flowable during filling of the container, the surgical spacer further comprising a conduit coupled to the container for accepting the material. 
   
   
       3 . The surgical spacer of  claim 2 , wherein the conduit comprises a one-way valve. 
   
   
       4 . The surgical spacer of  claim 1 , wherein the container is situated inside the structure. 
   
   
       5 . The surgical spacer of  claim 1 , wherein the container is situated outside the structure. 
   
   
       6 . The surgical spacer of  claim 1 , wherein the container is integral with the structure. 
   
   
       7 . The surgical spacer of  claim 1 , wherein the structure comprises a shape memory alloy. 
   
   
       8 . The surgical spacer of  claim 7 , wherein the shape memory alloy is body temperature activated. 
   
   
       9 . The surgical spacer of  claim 7 , wherein the shape memory alloy is superelastic. 
   
   
       10 . The surgical spacer of  claim 7 , wherein the shape memory alloy is coupled to an inside of the structure. 
   
   
       11 . The surgical spacer of  claim 7 , wherein the shape memory alloy is coupled to an outside of the structure. 
   
   
       12 . The surgical spacer of  claim 11 , wherein the structure comprises a plurality of interlocking links, and wherein the plurality of interlocking links comprise the shape memory alloy. 
   
   
       13 . The surgical spacer of  claim 7 , wherein the structure comprises a structural mesh, and wherein the shape memory alloy comprises at least one shape memory alloy wire within the structural mesh. 
   
   
       14 . The surgical spacer of  claim 1 , wherein the structure has at least a partially preformed shape. 
   
   
       15 . The surgical spacer of  claim 1 , wherein the structure comprises at least one substantially inflexible shaped member. 
   
   
       16 . The surgical spacer of  claim 15 , wherein the at least one substantially inflexible shaped member comprises a substantially straight member. 
   
   
       17 . The surgical spacer of  claim 15 , wherein the at least one substantially inflexible shaped member comprises a roughly U-shaped member. 
   
   
       18 . The surgical spacer of  claim 1 , wherein the container and the structure together comprise a layer of rubber thick enough to roughly maintain a desired shape. 
   
   
       19 . The surgical spacer of  claim 1 , wherein the container comprises at least one of silicone, rubber, polyurethane, polyethylene terephthalate (PET), polyolefin, polycarbonate urethane, and silicone copolymer. 
   
   
       20 . The surgical spacer of  claim 1 , wherein the material comprises at least one of a curable polymer and an adhesive. 
   
   
       21 . The surgical spacer of  claim 1 , wherein the structure comprises at least one of PET fabric, polypropylene fabric, polyethylene fabric and metal wire. 
   
   
       22 . The surgical spacer of  claim 1 , wherein the surgical spacer comprises an interspinous spacer, and wherein the structure is shaped to fit between adjacent spinous processes. 
   
   
       23 . The surgical spacer of  claim 1 , wherein the structure is shaped for spacing adjacent spinous processes, and wherein the surgical spacer is capable of resisting a compressive load with a stiffness of about 40 N/mm to about 240 N/mm. 
   
   
       24 . The surgical spacer of  claim 1 , wherein the structure is shaped to replace at least part of an intervertebral disc. 
   
   
       25 . The surgical spacer of  claim 1 , wherein the structure is at least partially permeable. 
   
   
       26 . An interspinous spacer, comprising:
 a flexible container for containing an injectable material that is compressible during end use, wherein the container is substantially impermeable to the injectable material;   a conduit coupled to the container for accepting the injectable material; and   a structure for at least part of the container when containing the material;   wherein the structure has a shape during end use to fit between adjacent spinous processes.   
   
   
       27 . The interspinous spacer of  claim 26 , wherein the structure is roughly H-shaped. 
   
   
       28 . The interspinous spacer of  claim 26 , wherein the structure comprises:
 at least one substantially inflexible member; and   a mesh for enveloping the at least one substantially inflexible member.   
   
   
       29 . The interspinous spacer of  claim 28 , wherein the at least one substantially inflexible shaped member comprises a substantially straight member. 
   
   
       30 . The interspinous spacer of  claim 28 , wherein the at least one substantially inflexible shaped member comprises a roughly U-shaped member. 
   
   
       31 . The interspinous spacer of  claim 26 , wherein the conduit comprises a one-way valve. 
   
   
       32 . The interspinous spacer of  claim 26 , wherein the container is situated inside the structure. 
   
   
       33 . The interspinous spacer of  claim 26 , wherein the container is situated outside the structure. 
   
   
       34 . The interspinous spacer of  claim 26 , wherein the container is integral with the structure. 
   
   
       35 . The interspinous spacer of  claim 26 , wherein the structure comprises a shape memory alloy. 
   
   
       36 . The interspinous spacer of  claim 35 , wherein the shape memory alloy is body temperature activated. 
   
   
       37 . The interspinous spacer of  claim 35 , wherein the shape memory alloy is superelastic. 
   
   
       38 . The interspinous spacer of  claim 35 , wherein the shape memory alloy is coupled to an inside of the structure. 
   
   
       39 . The interspinous spacer of  claim 35 , wherein the shape memory alloy is coupled to an outside of the structure. 
   
   
       40 . The interspinous spacer of  claim 39 , wherein the structure comprises a plurality of interlocking links, and wherein the plurality of interlocking links comprise the shape memory alloy. 
   
   
       41 . The interspinous spacer of  claim 35 , wherein the structure comprises a structural mesh, and wherein the shape memory alloy comprises at least one shape memory alloy wire within the structural mesh. 
   
   
       42 . The interspinous spacer of  claim 26 , wherein the structure has at least a partially preformed shape. 
   
   
       43 . The interspinous spacer of  claim 26 , wherein the structure comprises at least one substantially inflexible shaped member. 
   
   
       44 . The interspinous spacer of  claim 43 , wherein the at least one substantially inflexible shaped member comprises a substantially straight member. 
   
   
       45 . The interspinous spacer of  claim 43 , wherein the at least one substantially inflexible shaped member comprises a roughly U-shaped member. 
   
   
       46 . The interspinous spacer of  claim 26 , wherein the container and the structure together comprise a layer of rubber thick enough to roughly maintain a desired shape. 
   
   
       47 . The interspinous spacer of  claim 26 , wherein the container comprises at least one of silicone, rubber, polyurethane, polyethylene terephthalate (PET), polyolefin, polycarbonate urethane, and silicone copolymer. 
   
   
       48 . The interspinous spacer of  claim 26 , wherein the material comprises at least one of a curable polymer and an adhesive. 
   
   
       49 . The interspinous spacer of  claim 26 , wherein the structure comprises at least one of PET fabric, polypropylene fabric, polyethylene fabric and metal wire. 
   
   
       50 . A method of controlling at least part of a shape of a surgical spacer, the surgical spacer comprising a flexible container for containing a material that is compressible during end use, wherein the container is substantially impermeable to the material, and a structure for at least part of the container when containing the material, the method comprising creating the structure with at least one material for controlling at least part of a shape of the surgical spacer. 
   
   
       51 . The method of  claim 50 , wherein the creating comprises adding a shape memory alloy to the structure. 
   
   
       52 . The method of  claim 51 , wherein the structure comprises a structural mesh, and wherein the creating comprises adding at least one shape-memory alloy wire to the structural mesh. 
   
   
       53 . The method of  claim 51 , wherein the creating comprises coupling the at least one shape memory alloy to the structure. 
   
   
       54 . The method of  claim 50 , wherein the creating comprises adding at least one substantially inflexible shaped member to the structure. 
   
   
       55 . The method of  claim 50 , wherein the creating comprises adding a layer of rubber thick enough to roughly maintain a desired shape. 
   
   
       56 . A method of spacing adjacent spinous processes, the method comprising:
 providing an interspinous spacer, the interspinous spacer comprising:
 a flexible container for containing an injectable material that is compressible during end use, wherein the container is substantially impermeable to the injectable material; 
 a conduit coupled to the container for accepting the injectable material; and 
 a structure for at least part of the container when containing the material; 
 wherein the structure has a shape during end use to fit between adjacent spinous processes; 
   implanting the interspinous spacer between adjacent spinous processes; and   injecting the injectable material into the container through the conduit such that the shape is achieved.