STEERABLE VERTEBROPLASTY SYSTEM

• US 20090131886A1
• Filed: 11/16/2007
• Published: 05/21/2009
• Est. Priority Date: 11/16/2007
• Status: Abandoned Application

• Current Assignee: Osseon LLC (Merit Medical Systems, Inc.)
• Original Assignee: Osseon LLC (Merit Medical Systems, Inc.)
• Inventors: Lau, Jan R., Lyster, Michael T., Threlkeld, Judson E., Liu, Y. King
• Application Number:
  US11/941,764
• Publication Number:
  US 20090131886A1
• Time in Patent Office: Days
• US Class Current: 604/272
• 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 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61M 2025/009 the needle having a bent tip, i.e. the needle distal tip is angled in relation to the longitudinal axis of the catheter
• CPC Class Codes: A61M 2025/0092 Single injection needle protruding laterally from the distal tip
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• 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 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491

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 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 proximal end, a distal end, and a central lumen extending therethrough;

a deflectable zone on the distal end of the tubular body, deflectable through an angular range;

a handle on the proximal end of the tubular body; and

a deflection control on the handle;

wherein the handle and deflection control are configured for single hand operation.

2. A steerable vertebroplasty device as in claim 1, wherein the deflection control comprises a rotatable element.

3. A steerable vertebroplasty device as in claim 1, wherein the distal end comprises a distally facing exit port in communication with the central lumen.

4. A steerable vertebroplasty device as in claim 1, wherein the distal end comprises a laterally facing exit port in communication with the central lumen.

5. A steerable vertebroplasty device as in claim 1, further comprising an actuator extending axially between the deflection control and the deflectable zone.

6. A steerable vertebroplasty device as in claim 5, wherein the actuator comprises an axially moveable element.

7. A steerable vertebroplasty device as in claim 1, further comprising a port on the proximal end of the vertebroplasty device, in communication with the central lumen.

8. A steerable vertebroplasty device as in claim 7, wherein the deflectable zone is deflectable within a plane, and the port resides in the same plane.

9. A steerable vertebroplasty device as in claim 1, wherein the tubular body comprises a proximal zone and a distal, deflectable zone separated by a transition, and the transition is at least about 15% of the length of the tubular body from the distal end.

10. A system for performing vertebroplasty, comprising:

a steerable injection needle with a proximal portion, elongate shaft, and a distal portion, the distal portion movable from a first substantially straight configuration to a second configuration not substantially coaxial with the proximal portion; and

a cement dispensing pump comprising a first cartridge housing configured to house a cartridge containing two separate bone cement components; and

a mixing nozzle for mixing the first bone cement component and second bone cement component material into a bone cement composite.

11. The system of claim 10, further comprising a stylet for creating an access pathway in a pedicle.

12. The system of claim 10, further comprising an introducer cannula.

13. The system of claim 10, further comprising the first bone cement component, wherein the first bone cement component comprises MMA.

14. The system of claim 13, further comprising the second bone cement component, wherein the second bone cement component comprises from about 25% to about 35% by weight of bone particles.

15. The system of claim 13, further comprising the second bone cement material, wherein the second bone cement material comprises at least about 35% weight percent of bone particles.

16. The system of claim 10, wherein the steerable injection needle comprises an input port for receiving bone cement from the cement dispensing pump.

17. The system of claim 16, wherein the input port comprises a Luer lock.

18. The system of claim 10, wherein the steerable injection needle comprises an adjustment control configured to adjust the curvature of the distal end.

19. The system of claim 10, wherein the steerable injection needle comprises an end cap on the distal end of the needle.

20. The system of claim 10, wherein the steerable injection needle comprises a pull wire operably connected to the distal end of the needle.

21. The system of claim 10, wherein the steerable injection needle comprises a filter operably connected to a distal opening of the needle.

22. The system of claim 10, wherein the distal portion of the steerable injection needle has a working length of at least about 20% of the total working length of the needle.

23. The system of claim 10, wherein the steerable injection needle comprises a spring coil.

24. A closed vertebroplasty bone cement injection system, comprising:

a cartridge containing at least a first chamber and a second chamber;

a first bone cement component in the first chamber and a second bone cement component in the second chamber;

a mixing chamber, for mixing the first and second bone cement components;

an elongate injection needle, for directing bone cement into a treatment site in the spine; and

a closed flow path for directing the first and second bone cement components from the first and second chambers, through the mixing chamber, through the injection needle and into the spine at the treatment site.

25. A closed vertebroplasty bone cement injection system as in claim 24, wherein the cartridge is releaseably connected to the flow path.

26. A closed vertebroplasty bone cement injection system as in claim 24, wherein the mixing chamber is releaseably connected to the flow path.

27. A closed vertebroplasty bone cement injection system as in claim 24, wherein the injection needle is releaseably connected to the flow path.

28. A closed vertebroplasty bone cement injection system as in claim 24, wherein the injection needle has a deflectable distal end.