STEERABLE VERTEBROPLASTY SYSTEM WITH A PLURALITY OF CAVITY CREATION ELEMENTS

• US 20090299282A1
• Filed: 05/20/2009
• Published: 12/03/2009
• Est. Priority Date: 11/16/2007
• Status: Abandoned Application

• Current Assignee: Osseon LLC (Merit Medical Systems, Inc.)
• Original Assignee: Osseon Therapeutics Incorporated
• Inventors: Lichty, Robert C. II, Lau, Jan R., Lyster, Michael T.
• Application Number:
  US12/469,654
• Publication Number:
  US 20090299282A1
• Time in Patent Office: Days
• US Class Current: 604/99.01
• 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 17/8822 characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
• CPC Class Codes: A61B 17/8825 characterised by syringe details A61B17/8822, A61B17/8827 take precedence
• 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 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• 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 25/1011 Multiple balloon catheters
• 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 one or two or more cavity creation elements, such as inflatable balloons. A cavity creation element may include one or more filament layers. 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;

a deflection control on the handle;

a first cavity creating element carried by the deflectable zone; and

a second cavity creating element on the elongate tubular body.

2. A steerable vertebroplasty device as in claim 1, wherein the second cavity creating element is carried at least partially by the deflectable zone.

3. A steerable vertebroplasty device as in claim 1, wherein the first cavity creating element is a balloon.

4. A steerable vertebroplasty device as in claim 3, wherein the second cavity creating element is a balloon.

5. A steerable vertebroplasty device as in claim 4, wherein the first cavity creating element and the second cavity creating element share a common inflation lumen.

6. A steerable vertebroplasty device as in claim 4, wherein the first cavity creating element is operably connected to a first inflation lumen and the second cavity creating element is operably connected to a second inflation lumen.

7. A steerable vertebroplasty device as in claim 5, wherein the first cavity creating element and the second cavity creating element balloon are disposed proximally of an exit port on the tubular body.

8. 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 point, and the transition is at least about 15% of the length of the tubular body from the distal end.

9. A steerable vertebroplasty device as in claim 1, wherein the first cavity creating element comprises a braided layer.

10. A method of performing vertebroplasty, 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 through the introducer cannula into the interior of a vertebral body, the steerable injection needle having a proximal end and a distal end, the distal end having a first configuration substantially coaxial with a long axis of the proximal end, the steerable injection needle also having a first cavity creating element and a second cavity creating element;

rotating a control to deflect the distal end of the steerable injection needle to a second configuration that is not substantially coaxial with the long axis of the proximal end;

actuating the first cavity creating element to create a first cavity within the interior of the vertebral body;

actuating a second cavity creating element to create a second cavity within the interior of the vertebral body; and

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

11. The method of claim 10, wherein the first cavity creating element and the second cavity creating element are balloons.

12. The method of claim 11, wherein actuating the first cavity creating element comprises inflating the first balloon and actuating the second cavity creating element comprises inflating the second balloon.

13. The method of claim 12, wherein the first balloon and second balloon are inflated simultaneously.

14. The method of claim 11, wherein the first cavity creating element and the second cavity creating element share a common inflation lumen.

15. The method of claim 11, wherein the first cavity creating element is operably connected to a first inflation lumen and the second cavity creating element is operably connected to a second inflation lumen.

16. The method of claim 11, wherein flowing bone cement through the steerable injection needle into the interior of the vertebral body comprises releasing a first particle-containing bone cement within the interior of the vertebral body, the bone cement comprising at least 35% particles by weight, and additionally comprises releasing a second particle-containing bone cement within the first bone cement, the second particle-containing bone cement comprising less than about 35% particles by weight.

18. The steerable vertebroplasty device of claim 16, wherein the first cavity creating element is a balloon.

17. 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;

a deflection control on the handle; and

a cavity creating element carried by the deflectable zone,

wherein the cavity creating element comprises a filament layer.

19. 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;

a deflection control on the handle; and

a cavity creating element carried by the deflectable zone,

wherein the cavity creating element comprises a plurality of concentric balloons.