ULTRASONIC DEVICES AND METHODS TO DIAGNOSE PAIN GENERATORS

• US 20110105905A1
• Filed: 10/30/2009
• Published: 05/05/2011
• Est. Priority Date: 10/30/2009
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: McKay, William F.
• Granted Patent: US 8,597,192 B2
• Time in Patent Office: Days
• US Class Current: 600/459
• CPC Class Codes: A61B 1/3135 for examination of the epidural or the spinal space
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61B 2017/0073 with means for minimising or preventing pain during treatment
• CPC Class Codes: A61B 5/4824 Touch or pain perception evaluation A61B5/4821 takes precedence
• CPC Class Codes: A61B 8/4245 involving determining the position of the probe, e.g. with respect to an external reference frame or to the patient
• CPC Class Codes: A61B 8/4455 Features of the external shape of the probe, e.g. ergonomic aspects

Abstract

Ultrasonic devices and methods are provided that diagnose one or more pain generators. In some embodiments, the ultrasonic devices and methods are utilized to map one or more pain generators at or near the spine so that appropriate diagnostic and treatment methods can be performed.

Claims

1. An ultrasonic device for diagnosing a pain generator or a suspected pain generator at or near the spine in a patient suffering from pain, the ultrasonic device comprising an ultrasonic probe having a proximal end, a distal end, and a longitudinal axis therebetween, the ultrasonic probe configured to be moved at or near the pain generator or suspected pain generator;

an ultrasonic energy source that supplies the ultrasonic probe with an ultrasonic energy; and

a transducer for engaging the ultrasonic energy source and the proximal end of the ultrasonic probe to transfer the ultrasonic energy from the ultrasonic energy source along the longitudinal axis to the distal end of the ultrasonic probe, the ultrasonic energy having an intensity to deliver ultrasound energy and produce a pain signal when at least the distal end is at or near the pain generator or suspected pain generator.

2. An ultrasonic device according to claim 1, wherein the ultrasound energy has a low frequency in the approximate range of 15 kHz-20 MHz or 20 kHz-100 kHz or 25 kHz-50 kHz or 30 kHz-50 kHz.

3. An ultrasonic device according to claim 1, wherein the ultrasound energy has a low frequency in the approximate range of 0.7 MHz-3 MHz or 0.7 MHz-1 MHz.

4. An ultrasonic device according to claim 1, wherein the ultrasonic probe has a diameter of about 14 gauge to 25 gauge or 18 gauge to 25 gauge and a blunt tip.

5. An ultrasonic device according to claim 1, wherein (i) the ultrasonic probe is re-positioned at a suspected pain generator at a plurality of times before it is positioned at a pain generator, so that a location of the pain generator is diagnosed or (ii) the ultrasonic probe is re-positioned at a plurality of suspected pain generators before it is re-positioned at a plurality of pain generators so that locations of the pain generator can be mapped.

6. An ultrasonic device according to claim 1, wherein the distal end of the ultrasonic probe directly contacts and vibrates a tissue having the pain generator or the suspected pain generator at or near the spine to generate a pain signal.

7. An ultrasonic device according to claim 6, wherein the tissue is at least one muscle, ligament, tendon, cartilage near the spine, or spinal nerve, spinal disc, spinal foraminal space near the spinal nerve root, facet, annulus, or spinal canal.

8. An ultrasonic device according to claim 1, wherein (i) the ultrasonic device further comprises an introducer configured to penetrate skin, the introducer having an elongated shaft configured to receive the proximal and distal end of the ultrasonic probe or (ii) the ultrasonic probe is retractable or extendible or (iii) at least the distal end of the ultrasonic probe is retractable or extendible.

9. An ultrasonic device according to claim 8, wherein (i) the introducer is a needle, a catheter, a guide catheter or a sheath or (ii) the ultrasonic probe is retractable or extendible when placed within the introducer.

10. An ultrasonic device according to claim 8, wherein the ultrasonic probe comprises a substantially uniform diameter from the proximal end of the ultrasonic probe to the distal end of the ultrasonic probe.

11. An ultrasonic device according to claim 8, wherein the ultrasonic probe comprises a varying diameter from the proximal end of the ultrasonic probe to the distal end of the ultrasonic probe.

12. A method for diagnosing a location of a pain generator or a suspected pain generator at or near the spine in a patient suffering from pain, the method comprising:

positioning an ultrasonic probe at or near the pain generator or suspected pain generator, the ultrasonic probe having a proximal end, a distal end and a longitudinal axis there between, the ultrasonic probe supplied with ultrasonic energy from an ultrasonic energy source that transfers ultrasonic energy from a transducer to the proximal end of the ultrasonic probe along the longitudinal axis to the distal end of the ultrasonic probe; and

delivering sufficient ultrasonic energy from the distal end of the ultrasonic probe to tissue at or near the pain generator or suspected pain generator to produce a pain signal so as to diagnose the location of the pain generator or suspected pain generator.

13. A method according to claim 12, wherein the ultrasonic probe is re-positioned at a suspected pain generator a plurality of times before it is positioned at a pain generator, so that the location of the pain generator is diagnosed.

14. A method according to claim 12, wherein the ultrasonic probe is re-positioned at a plurality of suspected pain generators before it is re-positioned at a plurality of pain generators so that the location of the pain generators can be mapped.

15. A method according to claim 12, wherein the ultrasound energy has a low frequency in the approximate range of 15 kHz-20 MHz or 20 kHz-100 kHz or 25 kHz-50 kHz or 30 kHz-50 kHz.

16. A method according to claim 12, wherein the ultrasound energy has a low frequency in the approximate range of 0.7 MHz-3 MHz or 0.7 MHz-1 MHz.

17. A method according to claim 12, wherein the ultrasonic probe has a diameter of about 14 gauge to 25 gauge.

18. A method for diagnosing a pain generator at or near the spine in a patient suffering from pain, the method comprising:

positioning an ultrasonic probe at a target tissue site at or near the spine, the ultrasonic probe having a proximal end, a distal end and a longitudinal axis therebetween, the ultrasonic probe supplied with ultrasonic energy from an ultrasonic energy source that transfers ultrasonic energy from a transducer to the proximal end of the ultrasonic probe along the longitudinal axis to the distal end of the ultrasonic probe;

delivering a first dose of ultrasonic energy from the distal end of the ultrasonic probe to the target tissue site at or near the spine to produce a first pain signal;

re-positioning the ultrasonic probe at a second target tissue site at or near the spine;

delivering a second dose of ultrasonic energy from the distal end of the ultrasonic probe to the second target tissue site at or near the spine to produce a second pain signal; and

comparing the first dose and the first pain signal to the second dose and the second pain signal to diagnose the pain generator or suspected pain generator, wherein a greater pain signal indicates the presence of the pain generator.

19. A method for diagnosing a pain generator according to claim 19, wherein the first dose and the second dose are the same dose.

20. A method for diagnosing a pain generator according to claim 19, wherein (i) the positioning and re-positioning of the ultrasonic probe is performed using radiography, fluoroscopy, luminescence, positron emission tomography (PET), single photon emission computed tomography (SPECT), CT, MRI, and/or X-ray imaging techniques to triangulate one or more pain generators;

(ii) the positioning and re-positioning of the ultrasonic probe is performed to map one or more pain generators;

or (iii) one or more ultrasonic probes are used.