Internal Bone Fixation With Integrated Mixer

• US 20120065643A1
• Filed: 11/22/2011
• Published: 03/15/2012
• Est. Priority Date: 01/18/2008
• Status: Active Grant

• Current Assignee: Illuminoss Medical, Inc.
• Original Assignee: Illuminoss Medical, Inc.
• Inventors: Rabiner, Robert A., Rabiner, Daniel E., Rabiner, Raoul I., Basta, Leo L.
• Granted Patent: US 8,226,659 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 one or more bone cement components and an inner lumen;

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

a rotatable shaft, wherein the rotatable shaft is sized to pass through the inner lumen of the delivery catheter; and

a spinning mechanism, at the distal end of the rotatable shaft, and wherein the spinning mechanism is sized to pass through the inner lumen of the delivery catheter and into the internal bone fixation device,

wherein, when the internal bone fixation device is positioned within a cavity of the fractured bone, and the one or more bone cement components are positioned in the internal bone fixation device, the one or more bone cement components are mixable to a desired viscosity by activating the spinning mechanism within the internal bone fixation device.

2. The system of claim 1 further comprising an adapter releasably engaging the proximal end of the delivery catheter, wherein a first side-arm of the adapter receives the spinning mechanism and a second side-arm of the adapter receives a bone cement injection system housing the one or more bone cement components.

3. The system of claim 1 wherein the internal bone fixation device is shaped as an elongated cylinder.

4. The system of claim 1 wherein the one or more bone cement components include a powder component and a liquid component.

5. The system of claim 1 further comprising a handle, wherein the handle engages a drive mechanism for rotating the rotatable shaft.

6. The system of claim 1 wherein the spinning mechanism can rotate about a central axis.

7. The system of claim 1 wherein, when the internal bone fixation device resides within the cavity of the fractured bone, the internal bone fixation device spans at least two bone fragments and provides support to the at least two bone fragments.

8. The system of claim 1 wherein the internal bone fixation device evenly contacts a wall of a cavity of at least two bone fragments when in the second expanded state.

9. The system of claim 1 wherein a stress concentrator is disposed between the internal bone fixation device and the distal end of the delivery catheter to facilitate release of the internal bone fixation device from the delivery catheter.

10. The system of claim 1 wherein the spinning mechanism is releasably engaged to a distal end of the rotatable shaft.

11. The system of claim 1 further comprising a sensor located on the spinning mechanism wherein the sensor causes the spinning mechanism to stop spinning when a desired viscosity of the bone cement is reached.

12. 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 one or more bone cement components and an inner lumen;

an expandable internal bone fixation device releasably engaging the distal end of the delivery catheter, wherein the internal bone fixation device has a proximal end and a distal end;

a rotatable shaft sized to pass through the inner lumen of the delivery catheter;

an activable spinning mechanism releasably extending from the rotatable shaft, wherein the spinning mechanism is sized to pass through the inner lumen of the delivery catheter and into the internal bone fixation device, and wherein the spinning mechanism contacts and mixes the bone cement components; and

a releasing mechanism between the distal end of the delivery catheter and the proximal end of the internal bone fixation device.

13. The system of claim 12 wherein the releasing mechanism is designed to release of the internal bone fixation device.

14. The system of claim 12 wherein the releasing mechanism allows for the release of the internal bone fixation device and the rotatable shaft within the internal bone fixation device.

15. The system of claim 12 wherein the releasing mechanism includes a stress concentrator.

16. The system of claim 12 wherein, when the internal bone fixation device is positioned within a cavity of the fractured bone, and the one or more bone cement components are positioned within the expandable internal bone fixation device, the one or more bone cement components are mixable to a desired viscosity by activating the spinning mechanism within the internal bone fixation device.

17. The system of claim 12 further comprising an adapter releasably engaging the proximal end of the delivery catheter, wherein a first side-arm of the adapter receives the spinning mechanism and a second side-arm of the adapter receives a bone cement injection system housing the one or more bone cement components.

18. The system of claim 12 further comprising at least one radiopaque material on the expandable internal bone fixation device.

19. The system of claim 12 wherein the expandable internal bone fixation device has a predefined shape designed to fit inside the cavity of the fractured bone.

20. 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 expandable internal bone fixation device releasably engaging the distal end of the delivery catheter;

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

inserting an activable spinning mechanism through the delivery catheter and into the internal bone fixation device, wherein the spinning mechanism extends from the rotatable shaft;

rotating the rotatable shaft to activate the spinning mechanism to mix the bone cement components within the internal bone fixation device until a desired viscosity of the bone cement is reached, wherein the internal bone fixation device moves from a first compact state and a second expanded state;

removing the rotatable shaft and spinning mechanism from the device;

waiting for the mixed bone cement to cure; and

releasing the bone fixation device from the delivery catheter.