Systems and methods for intra-operative stimulation

• US 7,896,815 B2
• Filed: 04/06/2005
• Issued: 03/01/2011
• Est. Priority Date: 03/01/2005
• Status: Active Grant

• Current Assignee: Checkpoint Surgical, Inc.
• Original Assignee: Checkpoint Surgical, LLC
• Inventors: Strother, Robert B., Mrva, Joseph J., Thrope, Geoffrey B.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Pani; John
• Application Number:
  US11/099,848
• Publication Number:
  US 20060200207A1
• Time in Patent Office: 2,155 Days
• Field of Search: 600/554, 607 2- 76, 607115-156
• US Class Current: 600/554
• CPC Class Codes: A61B 17/1626 Control means; Display units
• CPC Class Codes: A61B 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/4519 Muscles A61B5/389, A61B5/224 take precedence
• CPC Class Codes: A61B 5/4523 Tendons
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 90/04 Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery protection of eyes against laser radiation A61F9/022
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters

Abstract

Improved assemblies, systems, and methods provide safeguarding against nerve injury during surgical procedures and/or identify nerve damage occurring prior to surgery and/or verify range of motion or attributes of muscle contraction during reconstructive surgery. A stimulation control device may incorporate a range of low and high intensity stimulation to provide a stimulation and evaluation of both nerves and muscles. A stimulation control device is removably coupled to a surgical device or is imbedded within the medical device to provide a stimulation and treatment medical device.

Claims

1. A hand-held tissue stimulation system comprising:

a tubular housing having a proximal end and a distal end, the housing being sized and configured to be held and controlled entirely within a surgical field and in a single hand by a user,

a stimulation control device positioned entirely within the housing, the stimulation control device comprising stimulation signal generating circuitry for generation of an electrical stimulation signal having an amplitude and a duration, a microcontroller electrically coupled to the stimulation signal generating circuitry, and a source of power for the stimulation control device,

a probe extending from the distal end of the housing and having an electrically conductive surface electrically coupled to the signal generating circuitry, the electrically conductive surface being sized and configured for contact with a targeted tissue region and, when in contact, applying the electrical stimulation signal to the targeted tissue region,

a return electrode electrically coupled to the signal generating circuitry and being sized and configured for contact with tissue to provide an electrical flow path for the stimulation signal from the probe back to the stimulation control device,

a first control device carried on the housing and electrically coupled to the microcontroller, the first control device being movable by a user from a first position to a second position for providing a power control input to the microcontroller to turn the stimulation signal generating circuitry on and from the second position through a plurality of control positions for providing amplitude control inputs to the microcontroller to control selection of the amplitude within a predefined amplitude range,

a second control device carried on the housing separate from the first control device and being electrically coupled to the microcontroller, the second control device being adjustable by a user independent of the first control device within a range of control positions for providing duration control inputs to the microcontroller to control adjustment of the duration from a predefined duration range, and

a single visual indicator carried on the housing and being electrically coupled to the microcontroller for confirming status conditions during operation of the stimulation control device, the microcontroller configured to cause the single visual indicator to display;

a prescribed color and/or flash rate of light confirming, independent of contact between the probe and the targeted tissue region, that power to the stimulation signal generating circuitry is on due to operation of the first control device, and a different prescribed color and/or flash rate of light confirming, when there is contact between the probe and the targeted tissue region, the delivery of the stimulation signal to the targeted tissue region through the probe and back to the stimulation control device through the return electrode, due to operation of the first and/or second control device.

2. A hand-held tissue stimulation system according to claim 1

wherein the predefined amplitude range includes about zero milliamps and increases to milliamps values greater than about zero.

3. A hand-held tissue stimulation system according to claim 1

wherein the predefined duration range includes about zero microseconds and increases through microseconds values greater than about zero.

4. A hand-held tissue stimulation system according to claim 1

wherein the stimulation signal is adapted to provide a physical motor response.

5. A hand-held tissue stimulation system according to claim 1

wherein the stimulation signal is adapted to provide an indication of an intact nerve to determine if a repair is needed.

6. A hand-held tissue stimulation system according to claim 1

wherein the stimulation signal is adapted to provide an indication of a muscle condition to identify whether the muscle is innervated or whether the muscle is intact or whether the muscle is severed.

7. A hand-held tissue stimulation system according to claim 1

wherein the stimulation signal is adapted to provide an indication of muscle and tendon length and function following a repair or tendon transfer prior to completing a surgical procedure.

8. A hand-held tissue stimulation system according to claim 1

wherein the electrically conductive surface of the probe comprises between about 1 millimeter and about 10 millimeters of a distal end of the probe.

9. A hand-held tissue stimulation system according to claim 1

wherein the probe comprises a diameter between about 0.5 millimeters and about 1.0 millimeters.

10. A hand-held tissue stimulation system according to claim 2

wherein the predefined amplitude range includes about zero milliamps and increases in steps to about 20 milliamps.

11. A hand-held tissue stimulation system according to claim 3

wherein the predefined duration range includes about zero microseconds and increases through about 200 microseconds.