STEERABLE VERTEBROPLASTY SYSTEM WITH CAVITY CREATION ELEMENT

• US 20120277755A1
• Filed: 04/20/2012
• Published: 11/01/2012
• Est. Priority Date: 11/16/2007
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Osseon Therapeutics Incorporated
• Inventors: Liu, Y. King, Lau, Jan R., Threlkeld, Judson E., Lyster, Michael T.
• Granted Patent: US 8,827,981 B2
• Time in Patent Office: Days
• US Class Current: 606/94
• 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 steerable vertebroplasty device, comprising:

an elongate, tubular body, having a first longitudinal axis, a proximal end, a distal end, and a central lumen, wherein the distal end comprises a deflectable zone deflectable through an angular range and an exit port in communication with the central lumen;

a handle on the proximal end of the tubular body;

an input port near the proximal end of the vertebroplasty device, in communication with the central lumen and configured to receive a bone filler media;

a deflection control on the handle operably attached to an axially movable actuator that is operably attached to the tubular body, wherein the deflection control is configured to rotate, and wherein upon rotation of the deflection control in a first direction an axial force is exerted on the movable actuator to change the curvature of the deflectable zone of the tubular body; and

a cavity creating element configured to compact cancellous bone and carried by the deflectable zone;

wherein the device is configured to be deflected using one-handed operation, wherein the device further comprises an input port positioned distally of the deflection control in communication with the central lumen, wherein the input port is configured to receive a bone cement, wherein the input port has a second longitudinal axis that forms an angle with respect to the first longitudinal axis;

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.

2. A steerable vertebroplasty device as in claim 1, wherein the cavity creating element comprises an inflatable balloon.

3. A steerable vertebroplasty device as in claim 2, wherein the inflatable balloon is disposed proximally of the exit port on the tubular body.

4. A steerable vertebroplasty device as in claim 1, wherein the length of the distal deflectable zone is at least about 15% of the length of the tubular body.

5. A steerable vertebroplasty device as in claim 1, wherein the deflection control is spaced proximally apart from a proximal end of the central lumen.

6. A steerable vertebroplasty device as in claim 1, wherein the axially movable actuator comprises a pull wire operably attached to the deflectable zone of the tubular body.

7. A steerable vertebroplasty device as in claim 1, wherein the axially movable actuator is operably attached to an inner side wall of the tubular body.

8. A steerable vertebroplasty device as in claim 1, wherein the axial force comprises a proximally directed force.

9. A steerable vertebroplasty device as in claim 1, wherein the deflection control comprises a dial.

10. A steerable vertebroplasty device as in claim 1, wherein the deflection control allows for continuous adjustment of the curvature of the deflectable zone of the tubular body.

11. A steerable vertebroplasty device as in claim 1, wherein the deflection control allows for discontinuous adjustment of the curvature of the deflectable zone of the tubular body.

12. A steerable vertebroplasty device as in claim 1, wherein the exit port is on a distal end of the deflectable zone.

13. A steerable vertebroplasty device as in claim 1, wherein the exit port is on a sidewall of the deflectable zone.

14. A steerable vertebroplasty device as in claim 1, wherein the first and second longitudinal axes are perpendicular to each other.

15. A steerable vertebroplasty device as in claim 1, wherein the deflection control is rotatable about the first longitudinal axis.

16. A steerable vertebroplasty device as in claim 1, wherein the input port comprises a luer connector.

17. A steerable vertebroplasty device as in claim 1, further comprising a removable obturator for removably occluding the exit port.

18. 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, the steerable injection needle having a proximal end, a tubular body having a longitudinal axis, and a distal end, 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;

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.

19. The method of claim 18, further comprising the step of creating a cavity to compact cancellous bone of the vertebral body.