Internal bone fixation system with integrated mixer

• US 7,842,040 B2
• Filed: 01/18/2008
• Issued: 11/30/2010
• Est. Priority Date: 01/18/2008
• Status: Active Grant

• Current Assignee: Illuminoss Medical, Inc.
• Original Assignee: Illuminoss Medical, Inc.
• Inventors: Rabiner, Robert A., Basta, Leo L., Rabiner, Raoul I., Rabiner, Daniel E.
• Primary Examiner(s): Barrett; Thomas C
• Assistant Examiner(s): Schaper; Michael T
• Application Number:
  US12/016,641
• Publication Number:
  US 20090187192A1
• Time in Patent Office: 1,047 Days
• Field of Search: 606 92- 94, 606/95, 606/63
• US Class Current: 606/92
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 17/7233 with special means of locking the nail to the bone
• CPC Class Codes: A61B 17/7275 with expanding cylindrical parts
• CPC Class Codes: A61B 17/7291 for small bones, e.g. in the foot, ankle, hand or wrist
• 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 2017/883 Means for indicating hardening of bone cement
• CPC Class Codes: A61M 2025/1054 having detachable or disposable balloons
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 2210/02 Bones
• 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: B01F 27/13 Openwork frame or cage stirrers not provided for in other groups of this subclass
• CPC Class Codes: B01F 27/2111 Flexible shafts

Abstract

Systems and methods for repairing a weakened or fractured bone are disclosed herein. A system for repairing a fractured bone includes a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, wherein the delivery catheter has an inner void for passage of bone cement components and an inner lumen for passage of a mixing element; an internal bone fixation device releasably engaging the distal end of the delivery catheter, wherein the internal bone fixation device moves from a first compact state to a second expanded state when the bone cement components are delivered to the internal bone fixation device and mixed within the internal bone fixation device; and a spinning mechanism engaged to a rotatable shaft, wherein the spinning mechanism is inserted into the internal bone fixation device.

Claims

1. A system for repairing a fractured bone comprising:

a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, wherein the delivery catheter has an inner void for passage of bone cement components and an inner lumen;

an internal bone fixation device releasably engaging the distal end of the delivery catheter and adapted to move from a first compact state to a second expanded state; and

a mixing element sized to pass through the inner lumen, the mixing element comprising a spinning mechanism releasably engaged to a distal end of a rotatable shaft, wherein the spinning mechanism is inserted into the internal bone fixation device and rotation of the rotatable shaft about a central axis rotates the spinning mechanism about the central axis so that the spinning mechanism contacts the bone cement components to mix the bone cement components together, and wherein the mixing element is sufficiently designed to disengage the spinning mechanism from the rotatable shaft.

2. The system of claim 1 further comprising an adapter releasably engaging the proximal end of the delivery catheter for receiving the mixing element and a bone cement injection system housing the bone cement components.

3. The system of claim 1 further comprising:

a stiffening member surrounding the elongated shaft of the delivery catheter;

a slip sleeve surrounding the stiffening member; and

at least one radiopaque material on the delivery catheter.

4. The system of claim 2 wherein the bone cement components include a powder component and a liquid component.

5. The system of claim 4 wherein the powder component is polymethylmethacrylate powder and the liquid component is methyl methacrylate.

6. The system of claim 4 wherein the bone cement injection system carries the liquid component of the bone cement, and the powder component of the bone cement is included in the internal bone fixation device.

7. The system of claim 1 wherein the mixing element further comprises a handle attached to the rotatable shaft, wherein the handle engages a drive mechanism for rotating the rotatable shaft.

8. The system of claim 1 for use in repairing a bone fractured into at least two bone fragments.

9. The system of claim 8 wherein the internal bone fixation device is adapted to reside within an inner cavity of the at least two bone fragments and provides support to the at least two bone fragments.

10. The system of claim 9 wherein the internal bone fixation device is adapted to evenly contact a wall of the inner cavity of the at least two bone fragments when in the expanded state.

11. A system for repairing a fractured bone comprising:

a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, wherein the delivery catheter has an inner void sufficiently designed for passage of a liquid component of a bone cement and an inner lumen;

an internal bone fixation device releasably engaging the distal end of the delivery catheter, wherein the internal bone fixation device comprises a powder component of a bone cement; and

a mixing element sized to pass through the inner lumen, the mixing element comprising a spinning mechanism having a plurality of blades extending from a rotatable shaft, wherein the plurality of blades are sufficiently designed to be positioned within the internal bone fixation device and rotation of the rotatable shaft about a central axis rotates the plurality of blades about the central axis so that the plurality of blades contact the powder component and the liquid component to mix the powder component and the liquid component together.

12. The system of claim 11 further comprising an adapter releasably engaging the proximal end of the delivery catheter for receiving the mixing element and a bone cement injection system housing the liquid component of the bone cement.

13. The system of claim 11 wherein the powder component is polymethylmethacrylate powder and the liquid component is methyl methacrylate.

14. The system of claim 11 wherein the mixing element further comprises a handle attached to the rotatable shaft, wherein the handle engages a drive mechanism for rotating the rotatable shaft.

15. The system of claim 11 for use in repairing a bone fractured into at least two bone fragments.

16. The system of claim 15 wherein the internal bone fixation device is adapted reside within an inner cavity of the at least two bone fragments and provide support to the at least two bone fragments.

17. The system of claim 15 wherein the internal bone fixation device is adapted to evenly contact a wall of the inner cavity of the at least two bone fragments when in an expanded state.

18. A system for repairing a fractured bone comprising:

a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, wherein the delivery catheter has an inner void sufficiently designed for passage of a liquid component of a bone cement and an inner lumen;

an internal bone fixation device releasably engaging the distal end of the delivery catheter, wherein the internal bone fixation device comprises a powder component of a bone cement; and

a mixing element sized to pass through the inner lumen, the mixing element comprising a spinning mechanism engaged to a rotatable shaft, wherein the spinning mechanism has a shape and size sufficiently designed for positioning within the internal bone fixation device and rotation of the rotatable shaft about a central axis rotates the spinning mechanism about the central axis so that the spinning mechanism contacts the powder component and the liquid component to mix the powder component and the liquid component together.

19. The system of claim 18 for use in repairing a bone fractured into at least two bone fragments.

20. A system comprising:

a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, wherein the delivery catheter has an inner void sufficiently designed for passage of a liquid component of a bone cement and an inner lumen;

an internal bone fixation device releasably engaging the distal end of the delivery catheter, wherein the internal bone fixation device comprises a powder component of a bone cement; and

a mixing element sized to pass through the inner lumen, the mixing element comprising a plurality of wire loops joined at a distal end extending from a rotatable shaft, wherein the plurality of wire loops are sufficiently designed to be positioned within the internal bone fixation device and rotation of the rotatable shaft about a central axis rotates the plurality of wire loops about the central axis so that the plurality of wire loops contact the powder component and the liquid component to mix the powder component and the liquid component together.