Nerve monitoring device

• US 8,886,280 B2
• Filed: 08/05/2010
• Issued: 11/11/2014
• Est. Priority Date: 01/23/2007
• Status: Active Grant

• Current Assignee: The Magstim Company Limited (Magstim Group, Incorporated)
• Original Assignee: The Magstim Company Limited (Magstim Group, Incorporated)
• Inventors: Kartush, Jack M.
• Primary Examiner(s): Dvorak, Linda
• Assistant Examiner(s): ANTISKAY, BRIAN MICHAEL
• Application Number:
  US12/851,300
• Publication Number:
  US 20100317956A1
• Time in Patent Office: 1,559 Days
• Field of Search: 600372-373, 600/380, 600/393, 600/466, 600/470, 600/546, 606/32, 606 46- 47, 607/40, 607/42, 607/44, 607/72
• US Class Current: 600/380
• CPC Class Codes: A61B 1/267 for the respiratory tract, e.g. laryngoscopes, bronchoscopes
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/394 specially adapted for electroglottography or electropalatography
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/6858 with a distal basket, e.g. expandable basket
• CPC Class Codes: A61B 5/6859 with multiple distal splines
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/6886 Monitoring or controlling distance between sensor and tissue
• CPC Class Codes: A61M 16/04 Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/0434 Cuffs
• CPC Class Codes: A61M 16/0488 Mouthpieces; Means for guiding, securing or introducing the tubes guiding or introducing with laryngoscopes A61B1/267; holding devices on the body A61M25/02
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/584 having a color code
• CPC Class Codes: A61M 2230/60 Muscle strain, i.e. measured on the user
• CPC Class Codes: A61N 1/0519 Endotracheal electrodes

Abstract

A nerve monitoring device, including a cannula, a sensor for monitoring a nerve, and an optional support element, can be inserted into an anatomic space. The cannula, sensor and/or support element can automatically conform to and match the geometry of the anatomic space, which can enhance desired contact between the sensor and anatomic features, such as muscles, nerves or tissue in the space in an atraumatic manner. The sensor, cannula and/or support element can include one or more strips or other elements that convert from a retracted mode to an expanded mode in which the strips or elements expand, enlarge or otherwise move to match the geometry of the space and place the sensors in precise monitoring proximity relative to the target muscles, nerves or tissues. An exemplary application of the device is in the field of laryngeal monitoring, however, the device is well suited for other applications.

Claims

1. A nerve monitoring device comprising:

a support element joined with a plurality of sensors and arranged to join a tube, the support element including a plurality of strips oriented generally parallel to the longitudinal axis of a tube, each strip having a strip sensor, the plurality of strips joined with a first connection element that at least partially surrounds a tube, the strips moveable between a retracted mode, in which the strips are positioned adjacent a tube, and an extended mode, in which at least a portion of the strips extend outwardly from a tube so that the strips conform to the anatomical geometry of at least a portion of a space of a subject in an atraumatic manner;

wherein two or more of the strips are placed immediately adjacent to each other so that the strips provide sufficient circumferential coverage such that rotational orientation does not affect the monitoring of at least one nerve; and

wherein at least one of the sensors is adapted to measure the activity of at least one nerve when placed in monitoring proximity so that a health care provider can be provided with information concerning the location of a nerve.

2. The device of claim 1 comprising:

an endotracheal tube configured for insertion into a laryngeal space of a subject, the endotracheal tube including a longitudinal axis;

the sensors joined with the endotracheal tube at a predetermined location corresponding to at least one of a target laryngeal muscle and a laryngeal nerve when the endotracheal tube is positioned through a glottic opening of the subject; and

an output element in communication with at least one of the sensor, the output element providing output indicative of measured activity of at least one of the target laryngeal muscle and the laryngeal nerve when a probe is positioned adjacent or on the laryngeal nerve;

wherein the support element includes a second connection element joined with the plurality of strips distal from the first connection element, wherein each of the plurality of strips are located between and joined with both the first connection element and the second connection element, wherein the second connection element is moveable toward the first connection element.

3. The device of claim 2 wherein each of the plurality of strips include a first end joined with the first connection element, a second end joined with the second connection element, and a central portion located between the first end and the second end.

4. The device of claim 3 wherein the central portion moves away from the endotracheal tube a greater distance then the first end moves away from the endotracheal tube when the strips are in the extended mode.

5. The device of claim 1 wherein the plurality of strips are flexible, and wherein the plurality of strips include a portion that bends outwardly to a generally convex configuration when the strips are moved from the retracted mode to the extended mode.

6. The device of claim 5 wherein the strips are formed in an accurate shape, wherein a band holds the strips in a linear shape in the retracted mode.

7. The device of claim 1 wherein the support element is joined with the sensors so that at least one of the sensors is located on an exterior of the support element and adapted to a nerve.

8. A laryngeal nerve monitoring device comprising:

an endotracheal tube configured for insertion into a laryngeal space of a subject, the endotracheal tube including a longitudinal axis;

a sensor joined with the endotracheal tube at a predetermined location corresponding to at least one of a target laryngeal muscle and a laryngeal nerve when the endotracheal tube is positioned through the glottic opening of the subject, a plurality of strips oriented generally parallel with the longitudinal axis of the endotracheal tube, the plurality of strips joined with a first connection element that at least partially surrounds the endotracheal tube, the strips moveable between a retracted mode, in which the strips are positioned adjacent the endotracheal tube, and an extended mode, in which at least portions of the strips are spaced outwardly a preselected distance from the endotracheal tube so that the strips conform to the anatomical geometry of at least a portion of the laryngeal space of the subject in an atraumatic manner; and

an output element in communication with the sensor, the output element providing output indicative of measured activity of at least one of the target laryngeal muscle and the laryngeal nerve when a probe is positioned adjacent or on the laryngeal nerve; and

an actuator joined with the sensor, the actuator adapted to engage at least one of the plurality of strips and the first connection element, the actuator adapted to enable the strips to move from the retracted mode to the extended mode,

wherein two or more of the strips are placed immediately adjacent to each other so that the sensor provides sufficient circumferential coverage such that it is placed in monitoring proximity to at least one of the laryngeal muscle and laryngeal nerve, and

wherein the sensor is adapted to measure the activity of the at least one of the target laryngeal muscle and the laryngeal nerve when placed in monitoring proximity to the at least one of the target laryngeal muscle and the laryngeal nerve, so that a health care provider can be provided with information concerning the location of the laryngeal nerve.

9. The device of claim 8 wherein the actuator is in the form of a band that circumferentiates the plurality of strips, wherein the band is moveable relative to the strips toward the first connection element.

10. A nerve monitoring device comprising:

a cannula configured for insertion into an internal body space of a subject, the cannula including a longitudinal axis;

a sensor joined with the cannula at a predetermined location, the predetermined location corresponding to at least one of a target muscle and a target nerve when the cannula is positioned in the internal body space of the subject;

a support element joined with a plurality of the sensors and the cannula, the support element including a plurality of strips, each strip having a strip sensor, the plurality of strips moveable between a retracted mode, in which the strips are positioned adjacent the cannula, and an extended mode, in which at least portions of the strips are spaced outwardly a preselected distance from the cannula so that the strips conform to the anatomical geometry of at least a portion of the internal body space of the subject in an atraumatic manner; and

an actuator joined with the support element, the actuator adapted to engage at least one of the plurality of strips so that the strips move from the retracted mode to the extended mode,

wherein two or more of the strips are placed immediately adjacent to each other so that the strips provide sufficient circumferential coverage such that under any orientation, at least one strip sensor is placed in monitoring proximity to at least one nerve; and

wherein the sensor is adapted to measure the activity of the at least one of the target muscle and the target nerve when placed in electrical proximity to the at least one of the target muscle and target nerve, so that a health care provider can be provided with information concerning the location of the target nerve so as to avoid unwanted damage or impairment thereto.

11. The device of claim 10 wherein the plurality of strips bend outwardly to a convex configuration in the extended mode.

12. The device of claim 10, further comprising a second connection element spaced from the first connection element, wherein the first connection element moves toward the second connection element when the support element transitions from the retracted mode to the extended mode.

13. The device of claim 12 wherein the first and second connection elements each are in a tubular form, the tubular form at least partially surrounding the cannula, wherein the first connection element is slidable along the cannula.

14. The device of claim 10 wherein the actuator includes a linking element that extends toward and is joined with at least one of the plurality of strips, wherein the at least one of the plurality of strips includes a first end and a second end and a central portion therebetween, wherein the first connection element is joined with the at least one of the plurality of strips at the first end, wherein the linking element is joined with the at least one of the plurality of strips in the central portion.

15. A laryngeal nerve monitoring device comprising:

a cannula configured for insertion into an internal body space of a subject, the cannula including a longitudinal axis;

a sensor joined with the cannula at a predetermined location corresponding to at least one of a target muscle and a target nerve when the cannula is positioned at least partially in the internal body space, the sensor including a plurality of strips oriented generally parallel with the longitudinal axis of the cannula, the plurality of strips joined with a first connection element, the strips moveable between a retracted mode, in which the strips are positioned adjacent the cannula, and an extended mode, in which the strips project outwardly a preselected distance from the cannula so that the strips conform to the anatomical geometry of at least a portion of the internal body space of the subject in an atraumatic manner; and

an actuator joined with the sensor, the actuator adapted to engage at least one of the plurality of strips and the first connection element, the actuator adapted to enable the strips to move from the retracted mode to the extended mode,

wherein a support element comprises a plurality of sensors, one or more arranged on each of the plurality of strips, with two or more of the strips placed immediately adjacent to each other to provide sufficient circumferential coverage such that at least one sensor is placed in monitoring proximity to at least one of the laryngeal muscle and laryngeal nerve without regard to the rotational orientation of the support element, and

wherein the sensor is adapted to measure the activity of the at least one of the target muscle and the target nerve when placed in monitoring proximity to the at least one of the target muscle and the target nerve, whereby a health care provider is provided with information concerning the location of the target nerve.

16. The device of claim 15 wherein the strips include a plurality of electrodes in an array circumferentially disposed around an outer circumference of the cannula, the array configured so that at least two of the electrodes can be in electrical contact with the at least one of the target muscle and target nerve regardless of the rotational orientation of the cannula within the internal body space when the sensor is in the extended mode.