Expandable device and methods of use

Inventors

Druma, Calin

Assignees

Medtronic Europe SARL

Abstract

A surgical system including an expandable device is provided, including an inflatable body, an inner shaft and an outer shaft. The inflatable body has at least one folded segment, which are housed in a distal portion of the outer shaft. The inflatable body is tethered to a portion of the outer shaft. The inner shaft is affixed to a portion of the inflatable body, and is configured to control an axial and/or a radial inflation pattern of the folded inflatable body.

Core Innovation

The disclosed invention relates to a spinal-surgery expandable device that includes an inflatable body having at least one axially folded segment housed within a distal outer-shaft housing portion. The inflatable body is tethered to an outer shaft and affixed to an inner shaft, and the inner shaft controls axial-first and/or radial inflation patterns. The device is described in an arrangement intended to allow the folded segments to self-extend in an axial direction during inflation.

In the described bone-fracture, vertebral compression fracture, and kyphoplasty context, the system includes inserting the expandable device via a cannula and inflating so that the balloon expands in an axial direction first. The inflation causes axially folded segments to flatten or self-extend axially, and the inner shaft can be locked or otherwise prevented from moving relative to the outer shaft to stop further axial dilation. Additional inflation then causes radial dilation to create a void in a bone.

After creation of the bone void, the described approach includes deflating and removing the expandable device, followed by inserting a bone void filler to cure. The disclosure also indicates debris-clearing by pushing debris to cortical walls and mentions that the device can be provided as part of a kit including a cannula and that the bone void filler can be a PMMA-based bone cement.

Claims Coverage

The independent claims cover methods that inflate an expandable-device balloon in two stages: axial expansion first, followed by radial expansion, with the inner shaft held from moving relative to the outer shaft. Across the independent claims, there are three main inventive concepts: coupling balloon portions to an outer shaft and a free-floating inner shaft, preventing relative inner/outer shaft movement during axial expansion, and then further inflating to drive radial expansion to create a void, including deflation/removal and void-filler insertion in one independent claim set.

The claim set is directed to axial-first inflation of a balloon coupled to an outer shaft and a free-floating inner shaft, holding the inner shaft from moving relative to the outer shaft during axial expansion, and then further inflating to expand radially. In the independent claim that includes an end-to-end bone procedure, the radial expansion is used to create a bone void, followed by deflating/removing the device and inserting a bone void filler into the void.

Stated Advantages

Documented Applications