Bone treatment systems and methods

• US 20060122621A1
• Filed: 08/20/2005
• Published: 06/08/2006
• 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
• Granted Patent: US 7,717,918 B2
• Time in Patent Office: Days
• US Class Current: 606/93
• 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 17/8822 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 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00084 Temperature
• 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 osteoplasty procedures such as vertebral compression fractures. More particularly, embodiments of the invention relate to instruments and methods for controllably restoring vertebral body height by controlling the geometry of bone cement introduced into the interior of a vertebra. An exemplary system utilizes Rf energy in combination a conductive bone cement for polymerizing the inflow plume to control the geometry of the fill material and the application of force caused by inflows of cement. In another embodiment, a method of treating bone includes utilizing a controller to control (i) bone cement inflow parameters and (ii) energy delivery parameters selectively modify the viscosity of a selected portion of bone cement as it is introduced. A system for treating bone includes an introducer for delivering bone and an energy source selectively coupleable to the bone cement to alter the viscosity of the fill material as it flows out of the introducer. One method includes pulsing the inflows of bone cement and further applying pulsed aspiration forces to the interior of the vertebra to relieve interior pressures to prevent emboli from migrating into the venous system.

Claims

1-47. -47. (canceled)

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

providing a flow source configured to provide a bone fill material inflow into a vertebral body;

inflowing bone fill material into the vertebral body;

measuring a characteristic of the bone fill material; and

adjusting an inflow parameter of the bone fill material inflow in response to the measured characteristic of the bone fill material.

49. The method of treating an abnormal vertebra as in claim 48, further comprising measuring a temperature of the bone fill material.

50. The method of treating an abnormal vertebra as in claim 48, wherein the inflow parameter comprises a volume of the bone fill material.

51. The method of treating an abnormal vertebra as in claim 48, wherein the inflow parameter is an injection pressure of the bone fill material.

52. The method of treating an abnormal vertebra as in claim 48, wherein the inflow parameter comprises an inflow rate of the bone fill material.

53. The method of treating an abnormal vertebra as in claim 48, wherein the inflow parameter comprises an acceleration of the bone fill material.

54. The method of treating an abnormal vertebra as in claim 48, wherein inflowing bone fill material includes measuring a temperature of the bone fill material in a distal end region of an introducer through which the bone fill material is delivered into the vertebral body.

55. The method of treating an abnormal vertebra as in claim 48, wherein inflowing bone fill material reduces a fracture in the vertebral body.

56. The method of treating an abnormal vertebra as in claim 48, wherein inflowing bone fill material moves cortical bone.

57. The method of treating an abnormal vertebra as in claim 48, wherein inflowing bone fill material moves cancellous bone.

58. The method of treating an abnormal vertebra as in claim 48, wherein inflowing bone fill material prophylactically treats the vertebra.

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

advancing an introducer into a vertebral body;

injecting bone fill material through the introducer into the vertebral body;

measuring a characteristic of the bone fill material with a sensor while the bone fill material is being injected into the vertebral body;

adjusting an inflow parameter of the bone fill material in response to the measured characteristic of the bone fill material; and

continuing the injection of bone fill material through the introducer into the vertebral body using the adjusted inflow parameter.

60. The method of claim 59, wherein measuring a characteristic of the bone fill material comprises measuring a temperature of the bone fill material.

61. The method of claim 59, wherein measuring a characteristic of the bone fill material comprises measuring an impedance of the bone fill material.

62. The method of claim 59, wherein measuring a characteristic of the bone fill material comprises measuring a viscosity of the bone fill material.

63. The method of claim 59, wherein measuring a characteristic of the bone fill material comprises measuring a volume of the bone fill material.

64. The method of claim 59, wherein adjusting an inflow parameter comprises increasing or decreasing an injection pressure of the bone fill material.

65. The method of claim 59, wherein adjusting an inflow parameter comprises increasing or decreasing an injection velocity of the bone fill material.

66. The method of claim 59, wherein adjusting an inflow parameter comprises increasing or decreasing an injection acceleration of the bone fill material.

67. The method of claim 59, wherein adjusting an inflow parameter comprises increasing or decreasing a viscosity of the bone fill material

68. The method of claim 67, wherein the viscosity of the bone fill material is adjusted by modifying an applied energy to the bone fill material.

69. The method of claim 59, comprising further adjusting an inflow parameter of the bone fill material multiple times in response to the measured characteristic of the bone fill material.

70. 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 flow of bone fill material into the vertebra through a channel of the introducer;

a sensor configured to measure a characteristic of the bone fill material; and

a controller configured to control at least one flow parameter of the bone fill material flow in response to the measured characteristic of the bone fill material.

71. The system for treating an abnormal vertebra of claim 70, wherein said. flow parameter is at least one of velocity, acceleration and volume of bone fill material flow.

72. The system for treating an abnormal vertebra of claim 70, wherein said flow parameter is pressure.

73. The system for treating an abnormal vertebra of claim 70, wherein the sensor is a temperature or an impedance sensor.

74. The system for treating an abnormal vertebra of claim 70, wherein the introducer comprises a distal end having a port configured for ejection of bone fill material flow in a direction non-parallel to an axis of the elongated introducer.

75. The system for treating an abnormal vertebra of claim 70, further including a radiopaque marker proximate the port.

76. The system for treating an abnormal vertebra of claim 70, further wherein the sensor is disposed on a distal portion of the introducer.

77. The system for treating an abnormal vertebra of claim 70, further comprising an energy source configured to apply energy to the bone fill material.