Bone treatment systems and methods

Patent metadata

Field	Value
Publication number	US-11672579-B2
Application number	US-201816200176-A
Country	US
Kind code	B2
Filing date	Nov 26, 2018
Priority date	Aug 22, 2005
Publication date	Jun 13, 2023
Grant date	Jun 13, 2023

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.

First claim

What is claimed is:

1. A bone treatment system comprising:
a bone fill material injector system comprising an injector configured to be at least partially introduced into a bone;
a source of a bone fill material comprising a bone cement;
a handle having a thermal energy emitter operatively coupled to the injector system and configured for delivering energy to a flow of the bone fill material through the injector system, wherein the handle includes:
the thermal energy emitter disposed therein;
a first coupling mechanism configured to selectively couple to the source of the bone fill material;
an electrical connector at least proximate to the first coupling mechanism;
one or more electrical leads extending between the electrical connector and the thermal energy emitter;
a second coupling mechanism configured to selectively couple to the bone fill material injector system, the second coupling mechanism being angled relative to the first coupling mechanism; and
a nonlinear flow passageway providing fluid communication between the first coupling mechanism and the second coupling mechanism, the nonlinear flow passageway including a first passageway portion having an opening proximate to the first coupling mechanism and a second passageway portion nonlinear relative to the first passageway portion and proximate to the second coupling mechanism, the thermal energy emitter at least partially encompassing the second passageway portion and being spaced from the opening of the first passageway portion proximate to the first coupling mechanism, wherein the thermal energy emitter comprises a polymeric positive temperature coefficient of resistance (PTCR) material; and

an electronic controller operably coupled to the electrical connector of the handle and configured to modulate the delivery of energy from the thermal energy emitter to the flow of the bone fill material to achieve a desired bone fill material viscosity.

2. The bone treatment system of claim 1 , wherein the thermal energy emitter comprises an elongated shape.

3. The bone treatment system of claim 1 , wherein the thermal energy emitter comprises spaced apart positive and negative electrodes.

4. The bone treatment system of claim 3 , wherein the positive and negative electrodes are radially, helically, or axially spaced apart.

5. The bone treatment system of claim 1 , wherein the polymeric positive temperature coefficient of resistance (PTCR) material is configured to generate a signal to indicate a rate of the flow of bone fill material.

6. The bone treatment system of claim 1 , wherein the controller comprises a plurality of settings, each setting configured to provide the delivery of a level of energy from the thermal energy emitter to the bone fill material to achieve a selected bone fill material viscosity.

7. The system claim 1 , further comprising a sensor system operatively coupled to the injector system or electronic controller, wherein the sensor system comprises an ambient temperature sensor in communication with the electronic controller, the controller configured to modulate the delivery of energy from the thermal energy emitter based at least in part on an ambient temperature sensed by the ambient temperature sensor.

8. The system claim 1 , further comprising a pressure delivery mechanism in communication with the electronic controller and coupleable to the injector system, the pressure delivery mechanism configured to apply a drive pressure to the flow of bone fill material, the electronic controller configured to control the pressure delivery mechanism to modulate the drive pressure based on a sensed operational parameter.

9. A bone treatment system comprising:
a bone fill material injector system comprising an injector configured to be at least partially introduced into a bone;
a handle having a thermal energy emitter operatively coupled to the injector system and configured for delivering energy to a flow of bone fill material through the injector system, wherein the handle includes:
the thermal energy emitter disposed within the handle of the injector system;
a first coupling mechanism configured to selectively couple to a source of bone fill material;
an electrical connector at least proximate to the first coupling mechanism;
one or more electrical leads extending between the electrical connector and the thermal energy emitter;
a second coupling mechanism configured to selectively couple to the bone fill material injector system, the second coupling mechanism being angled relative to the first coupling mechanism; and
a nonlinear flow passageway extending therethrough and providing fluid communication between the first coupling mechanism and the second coupling mechanism, the nonlinear flow passageway extending from a first passageway portion at a first exterior surface of the handle proximate to the first coupling mechanism to a second passageway portion nonlinear to the first passageway portion and at a second exterior surface of the handle proximate to the second coupling mechanism, wherein the thermal energy emitter at least partially encompasses the second passageway portion spaced from the first exterior surface of the handle; and

an electronic controller operably coupled to the electrical connector of the handle and configured to modulate the delivery of energy from the thermal energy emitter to the flow of bone fill material to achieve a desired bone fill material viscosity, wherein the controller comprises a plurality of settings, each setting configured to provide the delivery of a level of energy from the thermal energy emitter to the bone fill material to achieve a selected bone fill material viscosity.

10. The bone treatment system of claim 9 , wherein the thermal energy emitter comprises a polymeric positive temperature coefficient of resistance (PTCR) material.

11. The bone treatment system of claim 10 , wherein the thermal emitter comprises spaced apart positive and negative electrodes.

12. The bone treatment system of claim 11 , wherein the positive and negative electrodes are radially, helically, or axially spaced apart.

13. The bone treatment system of claim 10 , wherein the polymeric positive temperature coefficient of resistance (PTCR) material is configured to generate a signal to indicate a rate of the flow of bone fill material.

14. The bone treatment system of claim 9 , wherein the controller at a first setting is configured to modulate the delivery of energy from the thermal energy emitter to achieve a bone fill material viscosity of less than 1000 Pa·s, and wherein the controller at a second setting is configured to modulate the delivery of energy from the thermal energy emitter to achieve a bone fill material viscosity of greater than 1500 Pa·s.

15. The system claim 9 , further comprising a sensor system operatively coupled to the injector system or electronic controller, wherein the sensor system comprises an ambient temperature sensor in communication with the electronic controller, the controller configured to modulate the delivery of energy from the thermal energy emitter based at least in part on an ambient temperature sensed by the ambient temperature sensor.

16. The system claim 9 , further comprising a pressure delivery mechanism in communication with the electronic controller and coupleable to the injector system, the pressure delivery mechanism configured to apply a drive pressure to the flow of bone fill material, the electronic controller configured to control the pressure delivery mechanism to modulate the drive pressure based on a sensed operational parameter.

Assignees

• Dfine Inc

Inventors

• Truckai Csaba
• Luzzi Robert
• Kohm Andrew
• Shadduck John H

Classifications

• A61B2017/00411

  actuated by application of energy from an energy source outside the body · CPC title

• A61B2017/00022

  Sensing or detecting at the treatment site · CPC title

• A61B17/8816

  characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections · CPC title

• A61B17/8836 Primary

  for heating, cooling or curing of bone cement or fluid fillers · CPC title

• A61B2017/00955

  thermoplastic · CPC title