Bone treatment systems and methods

• US 7,722,620 B2
• Filed: 08/22/2005
• Issued: 05/25/2010
• Est. Priority Date: 12/06/2004
• Status: Active Grant

• Current Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Original Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Inventors: Shadduck, John H., Truckai, Csaba
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): CARTER, TARA ROSE E
• Application Number:
  US11/209,035
• Publication Number:
  US 20060122625A1
• Time in Patent Office: 1,737 Days
• Field of Search: 606/79, 606 92- 94, 606/105, 623 1711- 1712
• US Class Current: 606/93
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• 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 17/8827 with filtering, degassing, venting or pressure relief means
• 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 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/564 Methods for bone or joint treatment
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs

Abstract

The present invention relates in certain embodiments to medical devices for treating vertebral compression fractures. More particularly, embodiments of the invention relate to instruments and methods for controllably restoring vertebral body height by controlling the flow of bone cement into the interior of a vertebra and the application of forces causes by the cement flow. An exemplary system utilizes Rf energy in combination a conductive bone cement for selectively polymerizing the inflow plume to increase the viscosity of the cement. In one aspect of the invention, the system utilizes a controller to control bone cement flow parameters to either allow or disallow cement interdigitation into cancellous bone. A method of the invention includes pulsing the flows of bone cement wherein high acceleration of the flow pulses can apply expansion forces across the surface of the cement plume to reduce a vertebral fracture.

Claims

1. A method of treating an abnormal vertebra, comprising:

delivering energy to a bone fill material flow that flows through a delivery cannula to alter a viscosity of the bone fill material;

flowing a volume of the bone fill material flow, with a relatively high viscosity of at least about 1,000,000 cps, into a vertebral body under a first set of flow parameters;

interdigitating cancellous bone with at least a portion of the volume of bone fill material, wherein a computer controller controls an energy source to alter the fill material within a delivery cannula to the relatively high viscosity of at least about 1,000,000 cps sufficient to controllably permeate and interdigitate with cancellous bone;

flowing an additional volume of bone fill material with a relatively low viscosity into the vertebral body under a second set of flow parameters, different from the first set of flow parameters that substantially prevents interdigitation of the additional volume of bone fill material with cancellous bone;

applying forces to the cancellous bone and interdigitated fill material about a surface of the interdigitated bone fill material with the additional volume of bone fill material; and

controlling the viscosity of the bone fill material in response to a measured characteristic of the bone fill material flow, wherein the measured characteristic is selected from the group consisting of impedance, temperature, pressure, viscosity, flow parameters and volume.

2. A method of treating an abnormal vertebra as in claim 1, wherein adjusting at least one of said flow parameters comprises increasing a flow rate of bone fill material flow.

3. A method of treating an abnormal vertebra as in claim 1, wherein adjusting at least one of said flow parameters comprises adjusting a velocity of the bone fill material flow.

4. A method of treating an abnormal vertebra as in claim 1, wherein adjusting at least one of said flow parameters comprises adjusting an acceleration of the bone fill material flow.

5. A method of treating an abnormal vertebra as in claim 1, wherein adjusting at least one of said flow parameters comprises pulsing the bone fill material flow.

6. A method of treating an abnormal vertebra as in claim 1, further comprising repeatedly adjusting between the first and second sets of flow parameters to provide flows at different flow rates.

7. A method of treating an abnormal vertebra as in claim 1, wherein adjusting at least one of said flow parameters comprises varying pressure of the bone fill material flow.

8. A method of treating an abnormal vertebra as in claim 1, wherein the flow of the bone fill material is controlled by the computer controller that is adjustable between at least two conditions, the first condition allowing bone fill material interdigitation in cancellous bone, and the second condition substantially preventing bone fill material interdigitation in cancellous bone to control expansion forces applied to the cancellous bone.

9. A method of treating an abnormal vertebra as in claim 1, wherein delivering energy to the bone fill material flow comprises at least one of delivering energy from an electrical source and an ultrasound source.

10. A method of treating an abnormal vertebra as in claim 1, wherein flowing of the bone fill material reduces a fracture.

11. A method of treating an abnormal vertebra as in claim 1, wherein flowing of the bone fill material moves cancellous bone.

12. A method of treating an abnormal vertebra as in claim 1, wherein flowing of the bone fill material moves cortical bone.

13. A method of treating an abnormal vertebra, comprising:

providing a flow source configured to provide bone fill material inflows into an interior of a vertebra through an introducer and a controller configured to control the bone fill material inflows;

inflowing the bone fill material in pulses from the flow source into the interior of the vertebra, wherein the pulses of bone fill material flow comprise a first bone fill material flow with relatively high viscosity that interdigitates with cancellous bone and a second bone fill material flow with relatively low viscosity that does not substantially interdigitate with cancellous bone;

measuring a characteristic of the bone fill material with a sensor while the bone fill material is inflowing into the vertebra, wherein the characteristic is selected from the group consisting of impedance, temperature, pressure, viscosity, flow parameters and volume; and

controlling the change in viscosity between the pulses of the first bone fill material flow and the second bone fill material flow, at least in part in response to the measured characteristic of the bone fill material, such that the viscosity of the first bone fill material flow is greater than the viscosity of the second bone fill material flow by between about 100% to 1000%.

14. The method of treating an abnormal vertebra of claim 13, wherein the pulses of bone fill material flow occur at a frequency of between about 1 pulse per second and about 500 pulses per second.

15. The method of treating an abnormal vertebra of claim 13, wherein the pulses of bone fill material flow comprise relatively higher flow rate flows into the interior of the vertebra alternating with relatively slower flow rate flows.

16. The method of treating an abnormal vertebra of claim 15, wherein the pulses of bone fill material that flow at the relatively higher flow rate substantially prevent interdigitation of the bone fill material with cancellous bone and displace cancellous bone.

17. The method of treating an abnormal vertebra of claim 15, wherein the first, relatively high viscosity bone fill material flow is pulsed bone fill material that flows at a relatively slow flow rate and the second, relatively low viscosity bone fill material flow is pulsed bone fill material that flows at a relatively high flow rate.

18. The method of treating an abnormal vertebra of claim 13, further comprising inserting a sleeve into the interior of the vertebra, the sleeve extending from the interior of the vertebra to an exterior of a patient for relieving pressure in the interior of the vertebra.

19. The method of treating an abnormal vertebra of claim 18, further comprising applying a suction force through the sleeve.

20. The method of treating an abnormal vertebra of claim 19, further comprising pulsing a suction force.

21. A method of treating an abnormal vertebra, comprising:

injecting a first flow of bone fill material into a vertebral body at a first viscosity;

interdigitating the first flow of bone fill material with cancellous bone;

injecting a second flow of bone fill material into the vertebral body at a second viscosity, lower than the first; and

preventing the second flow of bone fill material from interdigitizing with the cancellous bone, wherein the second flow of bone fill material expands the cancellous bone with the interdigitated bone fill material;

sensing a characteristic of the flows of bone fill material, wherein the characteristic is selected from the group consisting of impedance, temperature, pressure, viscosity, flow parameters and volume; and

controlling viscosity of the bone fill material through a computer controller and the application of electrical or thermal energy to the bone fill material within a delivery cannula at least in part in response to the sensed characteristic, wherein there is a decrease in viscosity of at least 50% from the first flow to the second flow.

22. The method of claim 21, wherein the first bone fill material flow flows into the vertebral body at a first, slower flow rate to allow interdigitation with cancellous bone, and second bone fill material flow then flows at a higher flow rate that substantially prevents interdigitation with cancellous bone.

23. The method of claim 21, further comprising applying energy to the bone fill material to adjust its viscosity.

24. The method of claim 22, wherein the energy applied increases the viscosity of the bone fill material, the increased viscosity bone fill material interdigitating with cancellous bone.

25. The method of claim 21, further comprising adjusting at least one parameter of the bone fill material in multiple intervals to control flow of the bone fill material.

26. The method of claim 25, wherein energy is applied to the bone fill material in multiple intervals.

27. The method of claim 25, wherein flow of bone fill material into the vertebral body is pulsed.

28. A system for treating an abnormal vertebra comprising:

an elongated introducer configured for insertion into a vertebra;

a source of flowable bone fill material coupled to the introducer, the source configured to provide a pressurized inflow of bone fill material through the introducer;

a sensor that provides a measurement of a parameter of the bone fill material, wherein the parameter is selected from the group consisting of impedance, temperature, pressure, viscosity, flow parameters and volume; and

a computer controller configured to control at least one flow parameter of the bone fill material into the vertebra, the computer controller being adjustable between a first setting wherein the inflowing bone fill material has a first flow parameter capable of interdigitating with cancellous bone and a second setting wherein the inflowing bone fill material has a second flow parameter that substantially prevents interdigitation with cancellous bone, the computer controller further configured to control an application of thermal energy directly to the bone fill material, which control is separate from the control of the at least one flow parameter and based at least in part on the measured parameter.

29. The system for treating an abnormal vertebra of claim 28, wherein the at least one flow parameter is flow velocity.

30. The system for treating an abnormal vertebra of claim 28, wherein the at least one flow parameter is flow acceleration.

31. The system for treating an abnormal vertebra of claim 28, wherein the at least one flow parameter is a pulse rate of the pressurized flow of bone fill material.

32. The system for treating an abnormal vertebra of claim 31, wherein the controller pulses the pressurized flow at a rate of between about 1 pulse per second and about 500 pulses per second.

33. A method for treating a vertebral body, comprising:

providing a pulsing inflow of bone fill material into the vertebral body;

moving at least one of bone marrow, fat and blood within cancellous bone of the vertebral body by delivering the bone fill material at a flow rate that displaces the at least one of bone marrow, fat and blood within the cancellous bone;

measuring a characteristic of the bone fill material with a sensor, wherein the characteristic is selected from the group consisting of impedance, temperature, pressure, viscosity, flow parameters and volume; and

controllably applying thermal energy to the inflow of bone fill material, wherein the application of thermal energy is controlled at least in part on the measured characteristic of the bone fill material;

wherein the pulses of bone fill material flow comprise relatively higher flow rate flows, having relatively low viscosity, into the interior of the vertebral body alternating with relatively slower flow rate flows, having relatively high viscosity.

34. The method of claim 33, wherein the frequency at which the bone fill material is pulsed is between about 1 pulse per second and about 500 pulses per second.

35. The method of claim 33, wherein the pulses of bone fill material flow at the relatively higher flow rate substantially inhibit interdigitation of the bone fill material with cancellous bone and displace cancellous bone.

36. The method of claim 33, wherein the pulses of bone fill material flow at the relatively slower flow rate allow interdigitation of the bone fill material with cancellous bone.

37. The method of claim 33, wherein the moving bone marrow, fat and blood are removed.

38. The method of claim 37, further comprising:

inserting an aspirator into the interior of the vertebra; and

providing a suction force to remove at least a portion of the moving bone marrow, fat and blood.

39. The method of claim 38, wherein aspiration pulses are approximately synchronized with the pulsed bone fill inflows.

40. The method of claim 33, wherein the bone fill material comprises bone cement.

41. The method of claim 33, wherein the relatively low viscosity comprises about 50,000 cps and the relatively high viscosity comprises at least about 1,000,000 cps.

42. The method of claim 33, wherein the relatively high viscosity is at least 100% greater than the relatively low viscosity.

43. A method of treating a vertebral body, comprising:

providing an inflow of bone fill material into the vertebral body, wherein the inflow of bone fill material comprises relatively higher flow rate flows, having relatively low viscosity, into the interior of the vertebral body alternating with relatively slower flow rate flows, having relatively high viscosity and achieving these viscosities in a delivery cannula prior to inflowing into the vertebral bodies;

measuring a characteristic of the inflow of bone fill material, wherein the characteristic is selected from the group consisting of impedance, temperature, pressure, viscosity, flow parameters and volume;

controllably applying thermal energy to the inflow of bone fill material, wherein the application of thermal energy is controlled at least in part on the measured characteristic of the bone fill material;

displacing at least one of bone marrow, fat, blood and cancellous bone of the vertebral body by delivering the bone fill material at a flow rate that displaces the at least one of bone marrow, fat, blood and cancellous bone; and

extracting at least some of the at least one of bone marrow, fat, blood and cancellous bone from the vertebral body.

44. The method of claim 43, wherein the inflow of bone fill material is provided in pulses.

45. The method of claim 43, wherein extracting the at least some of the at least one of bone marrow, fat, blood and cancellous bone comprises aspirating the at least one of bone marrow, fat, blood and cancellous bone.