Bone treatment systems and methods

• US 10,136,934 B2
• Filed: 06/17/2015
• Issued: 11/27/2018
• Est. Priority Date: 08/22/2005
• Status: Active Grant

• Current Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Original Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Inventors: Truckai, Csaba, Luzzi, Robert, Kohm, Andrew, Shadduck, John H.
• Primary Examiner(s): Lawson, Matthew
• Assistant Examiner(s): Sipp, Amy
• Application Number:
  US14/741,864
• Publication Number:
  US 20150335369A1
• Time in Patent Office: 1,259 Days
• Field of Search: 606 92- 95
• 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 17/8836 for heating, cooling or curing of bone cement or fluid fillers
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00411 actuated by application of energy from an energy source outside the body
• CPC Class Codes: A61B 2017/00955 thermoplastic
• CPC Class Codes: A61B 2017/8844 Means for determining the viscosity of bone cement
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension

Abstract

Systems and methods for treating vertebral compression fractures are discussed. In an embodiment, a method includes mixing bone cement precursors thereby causing a first chemical curing reaction characterized by a first time-viscosity profile, controllably applying energy to the bone cement from an external source to modify the first time-viscosity profile to a second time-viscosity profile, and injecting the cement into bone at a substantially constant viscosity greater than about 1000 Pa·s to greater than about 5000 Pa·s over an extended working time. In another embodiment, a bone cement injector system is provided that includes a first handle component that is detachably coupled to a second sleeve component having a distal end for positioning in bone and a flow channel extending through the first and second components. The system includes first and second thermal energy emitters for delivering energy to bone cement flows in a flow channel portion in the first and second components, respectively.

Claims

1. A bone treatment system comprising:

a bone fill material injector configured to be at least partially introduced into a bone;

a handle comprising a flow passageway for a flow of bone fill material, and a thermal energy emitter disposed within the handle, the handle operatively coupled to the injector, the thermal energy emitter configured for delivering energy to the flow of the bone fill material within the flow passageway, wherein the flow passageway extends through the handle in a first direction and curves and extends in a second direction, substantially perpendicular to the first direction, forming a non-linear pathway through the handle, and wherein the thermal energy emitter at least partially encompasses a portion of the flow passageway and is disposed along the second direction near an outlet of the handle;

a sensor system, wherein the sensor system comprises a sensor configured to measure a rate of the flow of the bone fill material within the flow passageway; and

an electronic controller configured to modulate the delivery of the energy from the thermal energy emitter to the flow of the bone fill material based at least in part on a rate measurement from the sensor to achieve a desired bone fill material viscosity.

2. The system of claim 1, wherein the electronic controller is configured to provide a first level of applied energy from the thermal energy emitter to increase the viscosity of a first portion of the flow of the bone fill material to a first viscosity level, and a second level of applied energy from the thermal energy emitter to change the viscosity of a second portion of the flow of the bone fill material to a second viscosity level different than the first viscosity level.

3. The system of claim 2, wherein the second level of applied energy is less than the first level of applied energy.

4. The system of claim 3, further comprising alternatingly applying the first level of energy and the second level of energy to modulate the viscosity of the bone fill material about a mean value.

5. The system of claim 1, wherein the desired bone fill material viscosity is substantially constant.

6. The system of claim 1, further comprising a pressure delivery mechanism in communication with the electronic controller and coupleable to the handle, the pressure delivery mechanism configured to apply a drive pressure to the flow of the bone fill material, the electronic controller configured to control the pressure delivery mechanism to modulate the drive pressure based on the rate measurement.

7. The system of claim 6, wherein the rate measurement is measured immediately after pressurization of the bone fill material by the pressure delivery mechanism.

8. The system of claim 1, wherein the electronic controller is configured to modulate the delivery of the energy from the thermal energy emitter to the bone fill material to achieve a bone fill material viscosity chosen from a group consisting of at least 1500, at least 2000, at least 2500 Pa·

s, at least 3000 Pa·

s, at least 3500 Pa·

s, at least 4000 Pa·

s, at least 4500 Pa·

s, at least 5000 Pa·

s, and greater than 5000 Pa·

s.

9. The system claim 1, wherein the sensor system is operatively coupled to the injector, the handle, or the electronic controller, wherein the sensor system comprises one or more additional sensors configured to sense an operational parameter of the bone fill material.

10. The system of claim 9, wherein the sensor system comprises an ambient temperature sensor in communication with the electronic controller, the electronic controller configured to modulate the delivery of the energy from the thermal energy emitter based at least in part on an ambient temperature sensed by the ambient temperature sensor.

11. The system of claim 10, wherein the operational parameter sensed by the sensor system comprises a temperature of an enclosure that houses bone fill material precursors prior to mixing.

12. The system of claim 11, wherein the sensor system comprises a thermochromic ink that is visible on a surface of the enclosure and allows visual identification of temperature of the bone fill material precursors.

13. The system of claim 10, wherein the sensor system comprises one or more temperature sensors in thermal communication with a mixing vessel for measurement of a temperature of bone fill material precursors during mixing.

14. The system of claim 10, wherein the sensor system comprises one or more sensors configured to sense one or more of a bone fill material mixing start time, a bone fill material mixing stop time, a temperature of bone fill material precursors prior to mixing, and a temperature of bone fill material precursors during mixing.

15. The system of claim 10, wherein the sensor system and the electronic controller are operatively coupled such that the sensed operational parameters are automatically communicated to the electronic controller.

16. The system of claim 15, wherein the sensor system is electrically connected to the electronic controller.

17. The system of claim 1, wherein the electronic controller includes a visual display with an indicator of bone fill material viscosity.

18. The system of claim 1, wherein the electronic controller includes a visual display with an indicator of a remaining time interval in which bone fill material viscosity remains within a selected viscosity range.

19. The system of claim 1, wherein the sensor is operatively coupled to a motor drive configured to measure a force being applied by the motor drive.

20. A bone treatment system, comprising:

a handle component in communication with one or more energy sources, wherein an energy emitter is disposed within the handle component;

a sleeve component having a proximal portion attached to the handle component and a distal end configured for positioning in a bone, the handle and sleeve components defining a flow channel extending therethrough for a flow of bone fill material, wherein the flow channel extends through the handle in a first direction and curves and extends in a second direction, substantially perpendicular to the first direction, forming a non-linear pathway through the handle, and wherein the energy emitter at least partially encompasses a portion of the flow channel and is disposed along the second direction near an outlet of the handle;

the energy emitter configured for delivering energy to the bone fill material flow in a flow channel portion in the handle component;

a sensor configured to measure the flow of the bone fill material within the flow channel; and

a control system configured to alter the viscosity of the bone fill material based at least in part on a sensed flow.

21. The system of claim 20, wherein the handle component is detachably coupled to the sleeve component.

22. The system of claim 20, wherein a wall portion of the energy emitter comprises a polymeric positive temperature coefficient of resistance (PTCR) material capable of resistively heating adjacent bone fill material flows.

23. The system of claim 20, wherein the energy emitter is selected from a group consisting of resistive heaters, fiber optic emitters, light channels, ultrasound transducers, radiofrequency sources, electromagnetic energy sources, non-coherent light sources, electrodes, and antennas.

24. The system of claim 20, wherein the one or more energy sources are selected from a group consisting of voltage sources, radiofrequency sources, electromagnetic energy sources, non-coherent light sources, laser sources, LED sources, microwave sources, magnetic sources, and ultrasound sources.