BONE TREATMENT SYSTEMS AND METHODS

• US 20100249793A1
• Filed: 03/19/2010
• Published: 09/30/2010
• Est. Priority Date: 02/01/2008
• Status: Active Grant

• Current Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Original Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Inventors: Truckai, Csaba, Shadduck, John, Kohm, Andrew
• Granted Patent: US 9,161,798 B2
• Time in Patent Office: Days
• US Class Current: 606/92
• 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 2017/00084 Temperature
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders

Abstract

Systems and methods for treating vertebral compression fractures are provided. A kit can include at least one body containing a bone cement precursor to be mixed with at least one other bone cement precursor to form a bone cement. The body or a package containing the body can include at least one sensor. In some embodiments the sensor can be a temperature sensor. In some methods, data from the sensor can be used to determine certain parameters related to a treatment interval involving the bone cement.

Claims

1. A system for providing a bone cement for injection into a patient, comprising:

a bone cement kit comprising one or more packages of bone cement precursors, wherein the bone cement precursors are configured to combine to form a bone cement;

a data transmitter carried by at least one of the one or more packages, the data transmitter configured to communicate output data; and

a data receiver configured to receive the output data from the data transmitter and for providing a signal to one or both of an electronic controller and system operator, wherein the signal indicates a cement temperature.

2. The system of claim 1, wherein the signal further indicates a post-mixing start time for injecting the cement.

3. The system of claim 1, wherein the output data comprises at least one ID parameter selected from the group of monomer or polymer type, volume of monomer or polymer, and manufacturing lot of the monomer of polymer.

4. The system of claim 1, wherein the output data comprises a temperature of a monomer or polymer.

5. The system of claim 1, wherein the output data comprises a temperature log of a monomer or polymer.

6. The system of claim 1, wherein the signal is at least one of audible, visual or tactile.

7. The system of claim 1, wherein the one or more packages comprises at least one of a vial, ampule, tube, syringe, shipping carton, box, bag, sterile pouch, sterile sac and blister pack.

8. The system of claim 1, wherein the one or more packages comprises a first package containing a first component liquid monomer of the bone cement;

and a second package containing a second component powder of the bone cement.

9. A system for providing a bone cement for injection into a patient, comprising:

a bone cement kit comprising one or more packages of bone cement components, wherein the bone cement components are configured to combine to form a bone cement and include a liquid monomer component and a powder component; and

a data receiver configured to receive output data concerning the bone cement components from a data transmitter and for providing a signal to one or both of an electronic controller and system operator, wherein the signal indicates a cement temperature.

10. The system of claim 9, wherein the signal further indicates a post-mixing start time for injecting the cement.

11. The system of claim 9, further comprising the data transmitter, wherein the data transmitter is connected to one of the one or more packages.

12. The system of claim 9, wherein the output data comprises at least one ID parameter selected from the group of monomer or polymer type, volume of monomer or polymer, and manufacturing lot of the monomer of polymer.

13. The system of claim 9, wherein the output data comprises at least one of a temperature or a temperature log, of a monomer or polymer.

14. A system for providing a bone cement for injection into a patient, comprising:

a bone cement kit comprising one or more packages of bone cement components, wherein the bone cement components are configured to combine to form a bone cement and include a liquid monomer component and a powder component; and

at least one temperature sensor affixed to at least one package of the bone cement components, the sensor configured to indicate the temperature of said bone cement component.

15. The system of claim 14, wherein the one or more packages comprises at least one of a vial, ampule, tube, syringe, shipping carton, box, bag, sterile pouch, sterile sac and blister pack.

16. The system of claim 14, wherein said temperature sensor comprises a temperature strip.

17. The system of claim 14, wherein said temperature sensor comprises a thermochromic ink.

18. The system of claim 14, wherein said temperature sensor is affixed to the package of liquid monomer component.

19. A method for providing operational information concerning a bone cement, comprising:

providing a bone cement kit comprising one or more packages of bone cement precursors, wherein the bone cement precursors combine to form a bone cement and at least one of the one or more packages has a radio frequency tag affixed thereto;

receiving a signal from the radio frequency tag indicating data of one or more bone cement precursors;

mixing the bone cement precursors to form the bone cement; and

determining an operational step for the use of the bone cement based on the data.

20. The method of claim 19, wherein receiving said signal from the radio frequency tag is in response to an interrogation signal communicated from a controller to the one or more packages.

21. The method of claim 19, wherein the data is temperature.

22. The method of claim 19, wherein the data is temperature history.

23. The method of claim 19, wherein the operational step is wait time post-mixing.

24. A method for providing operational information concerning a bone cement, comprising:

providing a bone cement kit comprising at least two packages of bone cement precursors, and at least one temperature sensor affixed to one of the packages of bone cement precursors;

mixing the bone cement precursors to provide a bone cement; and

determining a bone cement injection start time based on temperature from the at least one temperature sensor.

25. The method of claim 24, wherein the determining step is derived from a chart.

26. The method of claim 24, wherein the determining step is provided by an algorithm and computer controller.

27. A method of determining a working condition of a curable bone cement, the method comprising:

determining a pre-mix temperature of at least one of first and second bone cement precursors;

determining an ambient temperature;

mixing the first and second bone cement precursors to form a bone cement; and

determining a bone cement injection start time based at least in part on an algorithm relating to said pre-mix and ambient temperatures.

28. The method of claim 27, further comprising actuating a controller and energy source to apply energy through an emitter to thereby apply heat to the bone cement post-mixing.

29. The method of claim 28, further comprising actuating the controller to modulate applied energy based on the pre-mix and ambient temperatures and/or the calculated injection start time.

30. The method of claim 28, further comprising actuating the controller to modulate hydraulic pressure based on the pre-mix and ambient temperatures and/or the calculated injection start time.

31. The method of claim 27, wherein the determining steps are accomplished at least by a temperature sensor affixed to containers and/or packaging of the first and second bone cement precursors.

32. The method of claim 27, wherein determining the pre-mix temperature comprises determining a pre-mix temperature history of at least one of first and second bone cement precursors.