Ultrasonic devices and methods to diagnose pain generators

• US 8,597,192 B2
• Filed: 10/30/2009
• Issued: 12/03/2013
• 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.
• Primary Examiner(s): CHAO, ELMER M
• Application Number:
  US12/609,198
• Publication Number:
  US 20110105905A1
• Time in Patent Office: 1,495 Days
• Field of Search: 601/2, 601/3, 600407-471, 367/7, 367/11, 367/130, 736/25, 736/26, 128/916
• US Class Current: 600/453
• 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. 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, wherein the distal end of the probe defines a blunt tip configured to penetrate the skin of the patient and comprises at least one orifice configured to deliver a coupling medium at the target tissue site and the proximal end is configured to remain outside the body of a patient, wherein the ultrasonic probe has a changing diameter from its proximal end to its distal end, the ultrasonic probe having a needle configured to penetrate skin, the needle having a channel therethrough configured to receive the proximal end and distal end of the ultrasonic probe, at least the distal end of the ultrasonic probe is retractable within the channel of the needle or extendible from the channel of the needle, and the distal end of the probe includes at least one LED sensor for tracking a position and direction of the probe, the LED sensor configured for positioning at or near a spinal disc or facet, the ultrasonic probe supplied with ultrasonic energy having a high frequency in the approximate range of 0.7 MHz-3 MHz or 0.7 MHz-1 MHz 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;

penetrating the skin with the needle;

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, and the first dose and the second dose are the same dose and the ultrasonic probe and needle are bent.

2. A method for diagnosing a pain generator according to claim 1, 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.

3. A method for diagnosing a pain generator according to claim 1, 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.

4. A method for diagnosing a pain generator according to claim 1, wherein the ultrasonic probe has a diameter of about 14 gauge to 25 gauge.

5. A method for diagnosing a pain generator according to claim 1, 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.