Internal Bone Fixation System with Integrated Mixer

• US 20090187192A1
• Filed: 01/18/2008
• Published: 07/23/2009
• 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.
• Granted Patent: US 7,842,040 B2
• Time in Patent Office: Days
• US Class Current: 606/93
• 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 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.

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 1 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 powder component of the bone cement is pre-loaded in the internal bone fixation device.

7. The system of claim 1 further comprising a handle engaging a drive mechanism for rotating the rotatable shaft.

8. The system of claim 7 wherein rotating the rotatable shaft causes the spinning mechanism to spin and mix together the bone cement components in the internal bone fixation device.

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

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

11. The system of claim 10 wherein the internal bone fixation device evenly contacts a wall of the inner cavity of the at least two bone fragments when in the expanded state.

12. A method for repairing a fractured bone comprising:

gaining access to an inner cavity of the fractured bone;

providing a system for use in repairing the fractured bone, the system comprising an internal bone fixation device releasably engaging a delivery catheter, the internal bone fixation device housing a powder component of a bone cement;

positioning the internal bone fixation device spanning at least two bone segments of the fractured bone;

adding a liquid component of the bone cement to the internal bone fixation device by passage through an inner void of the device;

inserting a mixing element through the delivery catheter and into the internal bone fixation device;

activating the mixing element to mix the powder component and the liquid component of the bone cement within the internal bone fixation device, wherein the internal bone fixation device moves from a first compact state to a second expanded state;

removing the mixing element from the device;

waiting for the mixed bone cement to cure, wherein the curing of the bone cement results in a hardened internal bone fixation device; and

releasing the hardened internal bone fixation device from the delivery catheter.

13. The method of claim 12 wherein the hardened internal bone fixation device remains in the inner cavity of the fractured bone to support the fractured bone.

14. The method of claim 12 wherein the delivery catheter further comprises:

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

a slip sleeve surrounding the stiffening member; and

at least one radiopaque material on the delivery catheter.

15. The method of claim 12 wherein the mixing element comprises a rotatable shaft engaging a spinning mechanism at a distal end, wherein rotating the rotatable shaft causes the spinning mechanism to spin and mix together the bone cement components within the internal bone fixation device.

16. The method of claim 12 wherein the powder component is polymethylmethacrylate powder and the liquid component is methyl methacrylate.

17. A method for repairing a fractured bone comprising:

gaining access to an inner cavity of the fractured bone;

providing a system for use in repairing the fractured bone, the system comprising an internal bone fixation device releasably engaging a delivery catheter, the internal bone fixation device housing a powder component of a bone cement;

positioning the internal bone fixation device spanning at least two bone segments of the fractured bone;

adding a liquid component of the bone cement to the internal bone fixation device by passage through an inner void of the device;

inserting a mixing element through the delivery catheter and into the internal bone fixation device, the mixing element comprising a spinning mechanism releasably engaging a rotatable shaft;

activating the mixing element to mix the powder component and the liquid component of the bone cement within the internal bone fixation device, wherein the internal bone fixation device moves from a first compact state to a second expanded state;

releasing the spinning mechanism from the rotatable shaft;

removing the rotatable shaft from the device;

waiting for the mixed bone cement to cure, wherein the curing of the bone cement results in a hardened rebar-enforced internal bone fixation device; and

releasing the hardened rebar-enforced internal bone fixation device from the delivery catheter.

18. The method of claim 17 wherein the hardened rebar-enforced internal bone fixation device remains in the inner cavity of the fractured bone to support the fractured bone.

19. The method of claim 17 wherein rotating the rotatable shaft causes the spinning mechanism to spin and mix together the bone cement components within the internal bone fixation device.

20. The method of claim 17 wherein the powder component is polymethylmethacrylate powder and the liquid component is methyl methacrylate.