Steerable vertebroplasty system with cavity creation element

• US 8,827,981 B2
• Filed: 04/20/2012
• Issued: 09/09/2014
• Est. Priority Date: 11/16/2007
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Osseon LLC (Merit Medical Systems, Inc.)
• Inventors: Liu, Y. King, Lau, Jan R., Threlkeld, Judson E., Lyster, Michael T.
• Primary Examiner(s): Price, Nathan R
• Application Number:
  US13/452,784
• Publication Number:
  US 20120277755A1
• Time in Patent Office: 872 Days
• Field of Search: 604/95.04, 604/95.05, 604/96.01, 604/506, 604/510, 604524-528, 604/530, 606 92- 94
• US Class Current: 604/506
• 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 17/8816 characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
• CPC Class Codes: A61B 17/8827 with filtering, degassing, venting or pressure relief means
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

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. The distal end may be provided with a cavity creation element, such as an inflatable balloon. Systems are also disclosed, including the steerable injection needle, introducer and stylet. The system may additionally include a cement delivery gun, one-time use disposable cement cartridges and a cement mixing chamber. Methods are also disclosed.

Claims

1. A method for treating a bone, comprising:

creating a pedicular access channel in a pedicle to access the interior of a vertebral body;

inserting an introducer cannula into the pedicle;

inserting a steerable injection needle configured for single hand operation through the introducer cannula into the interior of a vertebral body, wherein inserting the steerable injection needle comprises navigating the needle through cancellous bone, the steerable injection needle having a proximal end, a tubular body having a longitudinal axis, a central lumen, a distal end comprising an exit port in communication with the central lumen, a control for controlling deflection of the distal end, and an input port having a longitudinal axis and configured to receive bone cement, wherein the control is positioned proximally to the input port, wherein the longitudinal axis of the input port is not coaxial with the longitudinal axis of the tubular body, wherein the distal end has a first configuration substantially coaxial with the longitudinal axis of the tubular body, wherein the tubular body is substantially straight throughout its length from the input port to the exit port of the distal end in an unstressed state, wherein the steerable injection needle comprises an obturator disposed from at least the input port to slightly distally of the exit port for removably occluding the exit port, the obturator having a blunt atraumatic tip configured to prevent coring during insertion of the needle into the interior of the vertebral body;

removing the obturator from the steerable injection needle;

adjusting the control to deflect the distal end of the steerable injection needle to a second configuration that is not substantially coaxial with the longitudinal axis of the tubular body; and

flowing bone cement through the steerable injection needle into the interior of the vertebral body,

wherein removing the obturator from the steerable injection needle occurs prior to flowing bone cement through the steerable injection needle.

2. The method of claim 1, further comprising the step of creating a cavity to compact cancellous bone of the vertebral body.

3. The method of claim 1, wherein adjusting the control to deflect the distal end comprises rotating the control about the longitudinal axis of the body, thereby exerting an axial force on a pullwire operably connected to the distal end.

4. The method of claim 1, wherein flowing bone cement through the steerable injection needle into the interior of the vertebral body comprises flowing bone cement out a distally-facing exit port on the distal end of the steerable injection needle.

5. The method of claim 1, wherein the tubular body comprises stainless steel.

6. The method of claim 1, wherein the distal end of the tubular body comprises a plurality of transverse slots.

7. The method of claim 1, further comprising a proximal cap configured to threadably engage the input port and removably secure the obturator within the central lumen.