Constrained balloon disc sizer
An intradisc sizer is provided. The intradisc sizer includes a constrained expandable member, a longitudinal element, and a dispensing device. A fluid may be used to inflate the constrained expandable member, which is placed in an intradiscal space. Methods of using the intradisc sizer and implanting a spinal implant, and a kit containing the intradisc sizer, also are provided.
1 . An intradisc sizer device for determining at least one parameter of an intradiscal space, comprising:
a longitudinal element having distal and proximate ends and an axially concentric bore;
a constrained expandable member comprising an internal cavity, said member connected to and in fluid communication with the distal end of the longitudinal element; and,
a dispensing device capable of holding a fluid and adapted to be connected to and in fluid communication with the proximate end of the longitudinal element.
2 . The device of claim 1 , wherein the constrained expandable member comprises a polymeric material selected from the group consisting of polyethylene terephthalates, polyolefins, polyurethanes, nylon, polyvinyl chloride, silicone, polyetherketone, polylactide, polyglycolide, poly(lactide-co-glycolide), poly(dioxanone), poly([epsilon]-caprolactone), poly(hydroxylbutyrate), poly(hydroxylvalerate), tyrosine-based polycarbonate, polypropylene fumarate, and mixtures and combinations thereof.
3 . The device of claim 1 , wherein the constrained expandable member has a planar view, when the expandable member is substantially inflated, having a shape selected from the group consisting of a circle, ellipse, rectangle with rounded corners, kidney, and “C”-shaped.
4 . The device of claim 1 , wherein the dispensing device is a syringe graduated by volume.
5 . The device of claim 1 , wherein the fluid is selected from saline solution, air, and an imaging contrast medium.
6 . The device of claim 5 , wherein the imaging contrast medium is selected from the group consisting of X-ray, C-arm fluoroscopy, CT scan, MRI, and PET scan imaging contrast mediums.
7 . The device of claim 1 , wherein the longitudinal element is capable of moving between a linear and a curved configuration.
8 . The device of claim 1 , further comprising a guidewire positioned within the longitudinal element.
9 . The device of claim 1 , further comprising a guide shaft having an axially concentric bore, wherein the longitudinal element and constrained expandable member are capable of being positioned within the guide shaft.
10 . The device of claim 9 , wherein the constrained expandable member and the distal end of the longitudinal element are capable of extending beyond a distal end of the guide shaft.
11 . A kit for determining at least one parameter of an intradiscal space, comprising:
a longitudinal element having distal and proximate ends and an axially concentric bore;
a constrained expandable member comprising an internal cavity, said member capable of being connected to and in fluid communication with the distal end of the longitudinal element; and,
a dispensing device capable of holding a fluid, said device capable of being connected to and in fluid communication with the proximate end of the longitudinal element.
12 . The kit of claim 11 , further comprising a fluid capable of inflating the constrained expandable member.
13 . The kit of claim 12 , wherein the fluid is selected from a saline solution and an imaging contrast medium.
14 . The kit of claim 13 , wherein the imaging contrast medium is selected from the group consisting of X-ray, CT scan, MRI, and PET scan imaging contrast mediums.
15 . The kit of claim 11 , further comprising a guidewire that is capable of being positioned within the longitudinal element.
16 . The kit of claim 11 , further comprising a guide shaft having an axially concentric bore, wherein the longitudinal element and constrained expandable member are capable of being positioned within the guide shaft.
17 . A method for determining at least one parameter of an intradiscal space, comprising:
inserting a constrained expandable member into the intradiscal space;
inflating the constrained expandable member with a fluid;
measuring the volume of fluid used to inflate the constrained expandable member;
deflating the constrained expandable member; and,
removing the constrained expandable member from the intradiscal space.
18 . The method of claim 17 , wherein the fluid is selected from saline solution, air, and an imaging contrast medium.
19 . The method of claim 18 , wherein the fluid is an imaging contrast medium.
20 . The method of claim 19 , wherein the imaging contrast medium is selected from the group consisting of X-ray, CT scan, MRI, and PET scan imaging contrast mediums.
21 . The method of claim 19 , further comprising imaging the intradiscal space while the constrained expandable member is inflated with the imaging contrast medium.
22 . The method of claim 21 , wherein imaging the intradiscal space comprises an imaging procedure selected from the group consisting of X-ray, CT scan, MRI, and PET scans.
23 . A method of implanting a spinal implant in an intradiscal space, comprising:
removing at least a portion of a nucleus of an intervertebral disc;
inserting a constrained expandable member into the intradiscal space;
inflating the constrained expandable member with a fluid;
measuring the volume of the fluid used to inflate the constrained expandable member;
deflating the constrained expandable member;
removing the constrained expandable member from the intradiscal space;
selecting a spinal implant based at least on the volume of fluid used to inflate the constrained expandable member; and,
implanting the spinal implant.
24 . The method of claim 23 , wherein the fluid is selected from saline solution, air, and an imaging contrast medium.
25 . The method of claim 24 , wherein the fluid is an imaging contrast medium.
26 . The method of claim 25 , wherein the imaging contrast medium is selected from the group consisting of X-ray, CT scan, MRI, and PET scan imaging contrast mediums.
27 . The method of claim 25 , further comprising imaging the intradiscal space while the constrained expandable member is inflated with the imaging contrast medium.
28 . The method of claim 27 , wherein imaging the intradiscal space comprises an imaging procedure selected from the group consisting of X-ray, CT scan, MRI, and PET scans.
29 . The method of claim 23 , wherein the constrained expandable member has a shape similar to the shape of the spinal implant.