METHOD FOR PROVIDING DIRECTIONAL THERAPY TO SKELETAL JOINTS

• US 20150141876A1
• Filed: 11/12/2014
• Published: 05/21/2015
• Est. Priority Date: 01/15/2002
• Status: Active Grant

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Diederich, Chris J., Lotz, Jeffrey C., Nau, Will, Bradford, David S.
• Granted Patent: US 10,272,271 B2
• Time in Patent Office: Days
• US Class Current: 601/3
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 2017/00092 using thermocouples
• CPC Class Codes: A61B 2017/00101 using an array of thermosensors
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61N 2007/0021 Neural system treatment
• CPC Class Codes: A61N 2007/003 Destruction of nerve tissue
• CPC Class Codes: A61N 2007/0056 Beam shaping elements
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

An ultrasound therapy system and method is provided that provides directional, focused ultrasound to localized regions of tissue within body joints, such as spinal joints. An ultrasound emitter or transducer is delivered to a location within the body associated with the joint and heats the target region of tissue associated with the joint from the location. Such locations for ultrasound transducer placement may include for example in or around the intervertebral discs, or the bony structures such as vertebral bodies or posterior vertebral elements such as facet joints. Various modes of operation provide for selective, controlled heating at different temperature ranges to provide different intended results in the target tissue, which ranges are significantly affected by pre-stressed tissues such as in-vivo intervertebral discs. In particular, treatments above 70 degrees C., and in particular 75 degrees C., are used for structural remodeling, whereas lower temperatures achieve other responses without appreciable remodeling.

Claims

1. An energy delivery system for treating a region of tissue associated with a spinal joint, the system comprising:

an ultrasound treatment assembly comprising one or more directional ultrasound transducers;

a spinal joint delivery assembly that is adapted to deliver the ultrasound treatment assembly into the body with the one or more directional ultrasound transducers positioned at a location within the body associated with the spinal joint;

an ultrasound control system with a temperature control system, and an ultrasound drive system;

wherein the ultrasound treatment assembly is adapted to directionally deliver a therapeutic level of focused ultrasound energy in a first direction that is sufficient to necrose nociceptive nerve fibers in a vertebral body associated with the spinal joint without delivering a substantial level of ultrasound energy in a second direction opposite the first direction;

wherein the ultrasound treatment assembly is adapted to couple to the ultrasound control system; and

wherein the ultrasound control system is adapted to control the ultrasound energy being emitted by the one or more directional ultrasound transducers as a function of at least one parameter related to thermal therapy in the region of tissue.

2. The energy delivery system of claim 1, wherein the location is external to all of the vertebral bodies and all of the intervertebral discs of a spine.

3. The energy delivery system of claim 1, wherein the ultrasound treatment assembly is adapted to be positioned within a portion of a vertebral body and to provide thermal therapy to the vertebral body.

4. The energy delivery system of claim 1, wherein the spinal joint delivery assembly comprises an outer delivery device having a sharp pointed tip.

5. The energy delivery system of claim 1, wherein the one or more directional ultrasound transducers comprise two directional ultrasound transducers.

6. The energy delivery system of claim 1, wherein the one or more directional ultrasound transducers comprise a segmented array of tubular ultrasound transducers that are angularly directive with an inactive zone.

7. The energy delivery system of claim 1, wherein the one or more directional ultrasound transducers comprise a plurality of semi-hemispherically shaped transducers.

8. The energy delivery system of claim 1, wherein the ultrasound treatment assembly comprises a steerable catheter.

9. The energy delivery system of claim 1, wherein the ultrasound treatment assembly comprises a deflectable segment.

10. The energy delivery system of claim 1, wherein the at least one parameter comprises a parameter related to the effects of ultrasound energy delivery from the at least one ultrasound transducer in tissue.

11. The energy delivery system of claim 10, wherein the at least one parameter is selected from the group consisting of:

thermal dose, tissue temperature and depth of thermal penetration.

12. An energy delivery system for treating a region of tissue associated with a spinal joint, the system comprising:

an ultrasound treatment assembly comprising an ultrasound transducer;

a delivery assembly that is adapted to deliver the ultrasound treatment assembly into a body of a subject with the ultrasound transducer positioned at a location external to a vertebral body of the spinal joint;

wherein the ultrasound treatment assembly is adapted to deliver a therapeutic level of focused ultrasound energy from the external location and into the vertebral body sufficient to denervate nociceptive fibers within the vertebral body; and

wherein the external location is external to all of the vertebral bodies and all of the intervertebral discs of a spine of the subject.

13. The energy delivery system of claim 12, wherein the ultrasound treatment assembly comprises a segmented array of ultrasound transducers.

14. The energy delivery system of claim 12, wherein the ultrasound treatment assembly is adapted to deliver the focused ultrasound energy in a first direction into the vertebral body without delivering a substantial level of energy in a second direction opposite the first direction.

15. The energy delivery system of claim 12, wherein the ultrasound transducer comprises an inactive zone to angularly direct the ultrasound energy.

16. The energy delivery system of claim 13, wherein the ultrasound transducers comprise semi-hemispherically shaped transducers.

17. The energy delivery system of claim 12, further comprising an ultrasound control system having a temperature controller.

18. An energy delivery system for treating a region of tissue associated with a spinal joint, the system comprising:

a treatment assembly comprising one or more energy emitters;

a delivery assembly that is adapted to deliver the treatment assembly into the body such that the one or more energy emitters are positioned at a location external to the spinal joint within a body of a subject,

wherein the external location is external to all of the vertebral bodies and all of the intervertebral discs of a spine of the subject, and

wherein the one or more energy emitters are adapted to directionally deliver a therapeutic level of focused energy in a first direction that is sufficient to denervate nociceptive nerve fibers in a vertebral body of the spinal joint without delivering a substantial level of energy in a second direction opposite the first direction.

19. The energy delivery system of claim 18, wherein treatment assembly comprises a catheter, and wherein the one or more energy emitters comprise one or more directional ultrasound transducers.

20. The energy delivery system of claim 18, wherein the therapeutic level of focused energy is sufficient to necrose the nociceptive fibers.