MINIMALLY INVASIVE SPINE AUGMENTATION AND STABILIZATION SYSTEM AND METHOD

• US 20100262242A1
• Filed: 04/06/2010
• Published: 10/14/2010
• Est. Priority Date: 04/09/2009
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Inventors: Weber, Markus, Chavatte, Kris
• Granted Patent: US 8,911,497 B2
• Time in Patent Office: Days
• US Class Current: 623/17.120
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 17/7098 wherein the implant is permeable or has openings, e.g. fenestrated screw hollow surgical screws A61B17/864
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61B 2090/3937 Visible markers

Abstract

A minimally invasive system and method for vertebral body augmentation includes an expandable containment device, a chassis including an interior cavity for at least partially enclosing the expandable containment device, a first guidewire, a working cannula, a second guidewire having at least a partially flexible distal end portion and a sleeve for introducing bone filler material through a cannulated passageway of the sleeve and into an interior cavity of the containment device. The containment device preferably includes a plurality of pores for directing the outflow of bone filler material anteriorly within the vertebral body. The containment device and chassis are left interior to the vertebral body subsequent to height restoration and augmentation of the vertebral body.

Claims

1. A system for accessing and inserting a containment device within an interior volume of a vertebral body, the system comprising:

an expandable containment device including an outer surface encasing an interior cavity;

a chassis including an interior cavity for at least partially enclosing the expandable containment device;

a first guidewire;

a working cannula including a proximal end, a distal end and a hollow interior passageway extending from the proximal end to the distal end;

a second guidewire having at least a partially flexible distal end portion such that the distal end portion generally extends laterally across an anterior portion of the vertebral body when the second guidewire extends out of the cannula in an insertion position; and

a sleeve including a proximal portion, a distal portion and a cannulated passageway extending from the proximal portion to the distal portion, the sleeve being sized and configured to be inserted into the interior passageway of the working cannula, the distal portion of the sleeve being detachably coupled to the chassis, the proximal portion being operatively associated with a bone filler injecting mechanism for introducing bone filler material through the cannulated passageway of the sleeve and into the interior cavity of the containment device.

2. The system of claim 1, further comprising a plunger, the plunger including at least a partially flexible distal end portion and a cannulated bore so that the plunger can be advanced over the second guidewire.

3. The system of claim 1, wherein the chassis includes a leading end, a trailing end, an anterior portion and a posterior portion, the anterior portion including a window to enable and direct the outward expansion of the expandable containment device as the bone filler material is being introduced.

4. The system of claim 3, wherein the leading end of the chassis includes a taper nose.

5. The system of claim 3, wherein the chassis has a curvature similar to a curvature of the flexible distal end portion of the second guidewire

6. The system of claim 1, wherein the expandable containment device includes a first end portion, a second end portion and a middle portion therebetween, the middle portion having a circumference smaller than a circumference of either end portion.

7. The system of claim 6, wherein at least a portion of the middle portion of the containment device includes a plurality of anteriorly disposed cement-directing pores.

8. The system of claim 1, wherein the second guidewire is manufactured from a shape memory material so that the distal portion of the second guide wire can assume a straight configuration for insertion through the hollow interior passageway of the working cannula and thereafter reassume a bent or curved configuration upon exiting the distal end of the working cannula.

9. A minimally invasive method for augmenting a fractured or otherwise damaged vertebral body, the vertebral body including an anterior portion and a posterior portion, the method comprising the steps of:

inserting a first guidewire into the interior of the vertebral body through one of a transverse process and a pedicle of the vertebral body;

advancing a working cannula over the first guidewire and into contact with the vertebral body;

removing the first guidewire from the vertebral body while retaining the position of the working cannula;

advancing a second guidewire through the working cannula and into the interior of the vertebral body, the second guidewire including a curved distal portion that is advanceable through the working cannula, the curved distal portion assumes a curved configuration upon exiting a distal end of the working cannula, a convex side of the second guidewire faces the anterior portion of the vertebral body and a concave side of the second guidewire faces the posterior portion of the vertebral body in an inserted configuration, advancement of the second guidewire into the interior of the vertebral body creating a curvilinear introductory pathway;

advancing a plunger through the working cannula and over the second guidewire to increase a dimension of the curvilinear introductory pathway created by the second guidewire, the plunger including a curved distal portion that is slidable through the working cannula and assumes a curved configuration upon exiting the distal end of the working cannula;

removing the plunger while retaining the positions of the second guidewire and the working cannula;

advancing a cannulated sleeve through the working cannula and along the second guidewire, the cannulated sleeve detachably coupled at a distal end thereof to a chassis, the chassis at least partially surrounding an expandable containment device, the chassis including an anteriorly facing window for directing the expansion of the expandable containment device;

introducing a bone cement through the cannulated sleeve and into the expandable containment device, thereby causing the expandable containment device to expand anteriorly out of the window formed in the chassis and to secrete a bolus of bone cement anteriorly with respect to the chassis;

uncoupling and removing the distal end of the cannulated sleeve from the proximal end of the chassis; and

removing the second guidewire.

10. The method of claim 9, wherein the expandable containment device includes a first end portion, a second end portion and a middle portion therebetween, the middle portion having a circumference smaller than a circumference of either end portion, the middle portion further including a plurality of anteriorly disposed cement-directing pores.

11. The method of claim 9, wherein the bone cement introduction step comprises the steps of introducing an amount of a lower viscosity cement followed by the step of introducing an amount of a higher viscosity cement.

12. The method of claim 11, wherein introducing the amount of lower viscosity cement into the containment device causes the containment device to partially expand out of the window formed in the chassis and causes a small amount of bone cement to be secreted out of the containment device toward the anterior portion of the vertebral body.

13. The method of claim 12, wherein introducing the amount of higher viscosity cement into the containment device causes the containment device to further expand out of the window formed in the chassis, causes an additional amount of bone cement to be secreted out of the containment device toward the anterior portion of the vertebral body and restores a height of the vertebral body.