Steerable and curvable cavity creation system

• US 9,510,885 B2
• Filed: 01/08/2013
• Issued: 12/06/2016
• Est. Priority Date: 11/16/2007
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Osseon LLC (Merit Medical Systems, Inc.)
• Inventors: Burger, Keith, Cheatwood, Joshua, Chen, Shixin
• Primary Examiner(s): WOODALL, NICHOLAS W
• Application Number:
  US13/736,871
• Publication Number:
  US 20130345709A1
• Time in Patent Office: 1,428 Days
• Field of Search: 606/79, 606 92- 94, 606/105
• US Class Current: 1/1
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• CPC Class Codes: A61B 17/8827 with filtering, degassing, venting or pressure relief means
• CPC Class Codes: A61B 17/885 Tools for expanding or compacting bones or discs or cavities therein A61B17/8805, A61B17/7097 take precedence
• CPC Class Codes: A61B 17/8852 capable of being assembled or enlarged, or changing shape, inside the bone or disc
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 17/8858 laterally or radially expansible inflatable A61B17/8855
• CPC Class Codes: A61B 2017/00309 Cut-outs or slits
• CPC Class Codes: A61B 2017/00323 Cables or rods
• CPC Class Codes: A61B 2017/00331 with preformed bends

Abstract

Methods and devices for augmenting bone, such as in performing vertebroplasty are disclosed. A bone cement injection needle is provided, having a laterally deflectable distal end. Systems are also disclosed, including the steerable and curvable injection needle, introducer and stylet. The system can also include various exit ports that can be configured with clog-resistant features, such as an obturator. Steerable cavity creation systems and methods are also disclosed.

Claims

1. A steerable cavity creation device having a proximal end and a distal end, comprising:

an outer shaft having a proximal end and a distal end, an inner tubing extending therethrough, a first hypotube diposed within the inner tubing, and a second hypotube disposed within the first hypotube;

a deflectable zone on the distal end of the device, deflectable through an angular range, the deflectable zone having a proximal portion and a distal portion, wherein the first hypotube has a distal zone having a first plurality of Slots, and the second hypotube has a distal zone having a second plurality of slots, herein the first plurality of slots is oriented 180 degrees circumferentially apart from the second plurality of slots, wherein the first hypotube has a first longitudinal axis extending from the proximal end to the proximal portion of the deflectable zone, wherein the deflectable zone is movable from a first substantially straight configuration in an a unstressed state to a second deflected configuration;

a deflection controller on the proximal end of the device, wherein the deflection controller is actuated by rotation about the first longitudinal axis of the first hypotube, wherein upon rotation of the deflection controller a proximally directed force is exerted on a movable actuator attached to the second hypotube to actively change the curvature of the deflectable zone, wherein the first hypotube is held stationary when the movable actuator applies a force to the second hypotube;

an input port positioned distally on the second hypotube relative to the deflection controller;

a cavity creating element carried by the deflectable zone, wherein the cavity creating element comprises a balloon having a balloon chamber, wherein the balloon has as proximal neck and a distal neck, wherein the proximal neck is attached to the distal end of the outer shaft and the distal neck is attached to the inner tubing, wherein the inner tubing is configured to seal the balloon chamber; and

a distal tip positioned over the distal neck of the balloon and over a distal end of the first hypotube and a distal end of the second hypotube.

2. The cavity creation device of claim 1, wherein the first plurality of slots each have an axial width that is between about 1.5x and 3x of the axial width of each of the second plurality of slots.

3. The cavity creation deice of claim 1, wherein the axial width of each of the second plurality of slots is between about .001″

and, 005″

.

4. The cavity creation device of claim 1, wherein the total distance of the second plurality of slots is at least the number of the first plurality of slots.

5. The cavity creation device of claim 1, wherein the device has a closed distal end.

6. The cavity creation device of claim 1, wherein the first hypotube and the second hypotube are comprised of metal.

7. The cavity creation device of claim 6, wherein the distal end of the first hypotube and the distal end of the second hypotube are attached to each other at the distal tip.

8. The cavity creation device of claim 7, wherein the distal end of the first hypotube and the distal end of the second hypotube are attached to each other at the distal tip by welding.