Method for balloon-aided vertebral augmentation
View Patent ↗An expandable member bone augmentation system and single-access-point methods for bone augmentation using same are provided. In certain embodiments, a pre-curved stylet with an overlying delivery tube may be used to target an approximately centered target site within a bone structure, facilitating direction thereto of an expandable member useful for creating a cavity that may receive curable material to restore bone height and/or to reinforce the bone structure. An expandable member such as, for example, a balloon can be used to create a plurality of voids by displacing bone material, where the voids can be filled with curable material to augment the bone.
1. A method for stabilizing a bone structure, the method comprising:
directing an access cannula, with a longitudinal axis, into a bone structure;
directing a polymer delivery tube through an access site into the bone structure, where the delivery tube extends through and beyond a distal end of the access cannula to a first target region, forming a tubular cavity along a delivery tube length within the bone structure;
retracting longitudinally the delivery tube from a distal portion of the tubular cavity;
directing an expandable member to, and then expanding the expandable member in, the distal portion of the tubular cavity to form a first cavity having a larger diameter than the tubular cavity;
deflating, then retracting longitudinally the expandable member and the delivery tube to a desired location in the tubular cavity which location is nearer than the location of the first cavity to the access site;
expanding again the expandable member in the desired location of the tubular cavity, to form a second cavity with a larger diameter than the tubular cavity and disposed between the first cavity and the access site; and
filling at least a portion of the first cavity and the second cavity with a curable material.
2. The method of claim 1 , where the step of directing a delivery tube comprises providing a stylet disposed longitudinally through the delivery tube, where said stylet has either a solid cross-section or an internal delivery lumen dimensioned and oriented for delivering curable material; and
further comprising steps of
removing the stylet before the step of directing and expanding the expandable member.
3. The method of claim 1 , where the bone structure is selected from a group consisting of a vertebra, a long bone, an irregular bone, or a flat bone.
4. The method of claim 3 , where bone structure is a vertebra, and the access cannula is directed through a single pedicle of the vertebra.
5. The method of claim 1 , where the second cavity is generally separate and distinct from the first cavity, except for a connecting portion of the tubular cavity.
6. The method of claim 1 , where the expandable member includes a fluid-inflatable balloon configured to create a cavity by displacing material adjacent the tubular cavity.
7. The method of claim 1 , where the second cavity is substantially continuous with the first cavity.
8. The method of claim 1 , further comprising expanding yet again the expandable member in a still less-distal portion of the tubular cavity to form at least a third cavity and filling at least a portion of the at least a third cavity with a curable material.
9. The method of claim 1 , where the first cavity and the second cavity are offset relative to each other with respect to a longitudinal axis of the access cannula.
10. The method of claim 1 , where the step of filling at least a portion of the first cavity and the second cavity further includes steps of:
removing the delivery tube;
directing to the first and/or the second cavity a distal portion of a delivery cannula including an internal delivery lumen dimensioned and oriented for delivering curable material; and
delivering the curable material via the internal delivery lumen.
11. Providing a kit and instructions for implementing the method of claim 1 .
12. A method for stabilizing a bone structure, the method comprising:
directing an access cannula, with a longitudinal axis, into a bone structure through only a single access point;
deploying an expandable member through the access cannula into the bone structure;
expanding, contracting, moving, then re-expanding the expandable member along a track, within the bone structure more than one time to form a plurality of cavities within the bone structure, wherein the track is curved with respect to the longitudinal axis of the access cannula; and
filling the plurality of cavities at least partially with a curable material via a pre-curved stylet including an internal delivery lumen dimensioned and oriented for delivering curable material.
13. The method of claim 12 , where the bone structure is selected from a group consisting of a vertebra, a long bone, an irregular bone, or a flat bone.
14. The method of claim 13 , where the single access point is comprised by a pedicle of the vertebra.
15. The method of claim 12 , where the plurality of cavities are generally continuous, together forming a larger cavity along the curved track.
16. The method of claim 12 , where the plurality of cavities includes three or more cavities.
17. The method of claim 12 , wherein:
the step of deploying an expandable member through the access cannula further comprises providing a delivery tube coaxially disposed through the access cannula with a stylet disposed longitudinally through the delivery tube to form the curved track; and
the step of deploying the expandable member includes removing the stylet from the delivery tube.
18. The method of claim 12 , where the expandable member includes a fluid-inflatable balloon configured to create a cavity by displacing material adjacent the tubular cavity.
19. The method of claim 12 , where each cavity of the plurality of cavities is offset relative to other cavities with respect to the longitudinal axis of the access cannula.
20. Providing a kit and instructions for implementing the method of claim 12 .