Steerable vertebroplasty system

• US 7,842,041 B2
• Filed: 10/30/2008
• Issued: 11/30/2010
• Est. Priority Date: 11/16/2007
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Osseon Therapeutics Incorporated
• Inventors: Lyster, Michael T, Threlkeld, Judson E., Liu, Y. King, Lau, Jan R.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Price; Nathan R
• Application Number:
  US12/261,987
• Publication Number:
  US 20090131948A1
• Time in Patent Office: 761 Days
• Field of Search: 604/95.01, 604/95.04, 604/524, 604/528, 606 92- 95
• US Class Current: 606/94
• 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 system for performing vertebroplasty, comprising:

a steerable injection needle configured for one hand operation including an elongate shaft having a proximal portion having a proximal end and a deflectable distal portion having a proximal end distal end, and an opening from which bone cement can exit from the distal portion, wherein the elongate shaft further comprises a first longitudinal axis extending from the proximal end of the proximal portion to the proximal end of the deflectable distal portion, the steerable injection needle further comprising an input port having a second longitudinal axis spaced apart from and at an angle with respect to the first longitudinal axis of the steerable injection needle for receiving bone cement from a cement dispensing pump, wherein the elongate shaft from the proximal end of the deflectable distal portion to the distal end is movable from a first substantially straight configuration to a second configuration not substantially coaxial with the proximal portion, wherein the steerable injection needle further comprises an adjustment control configured to move the distal portion of the elongate shaft from the first configuration to the second configuration, the adjustment control located proximal on the injection needle relative to the input port;

a cement dispensing pump configured to house a first bone cement component and a second bone cement component; and

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

2. The system of claim 1, further comprising a stylet for creating an access pathway in a pedicle.

3. The system of claim 1, further comprising an introducer cannula.

4. The system of claim 1, further comprising the first bone cement component, wherein the first bone cement component comprises MMA.

5. The system of claim 4, further comprising the second bone cement component.

6. The system of claim 4, further comprising the second bone cement component, wherein the second bone cement component comprises at least about 35% weight percent of bone particles.

7. The system of claim 1, wherein the input port comprises a Luer lock.

8. The system of claim 1, wherein the steerable injection needle comprises an end cap on the distal end of the deflectable distal portion of the elongate shaft.

9. The system of claim 1, wherein the steerable injection needle comprises a pull wire operably connected to the distal end of the deflectable distal portion of the elongate shaft.

10. The system of claim 1, wherein the steerable injection needle comprises a filter operably connected to a distal opening of the deflectable distal portion of the elongate shaft.

11. The system of claim 1, wherein the distal portion of the elongate shaft has a working length of at least about 20% of the total working length of the needle.

12. The system of claim 1, wherein the steerable injection needle comprises a spring coil.

13. The system of claim 1, wherein the deflectable distal portion of the elongate shaft is movable from a first substantially straight configuration in an unstressed state to a second deflected configuration.