Method and apparatus for performing a peripheral nerve block

• US 10,220,180 B2
• Filed: 04/28/2016
• Issued: 03/05/2019
• Est. Priority Date: 10/16/2015
• Status: Active Grant

• Current Assignee: Milestone Scientific Incorporated
• Original Assignee: Milestone Scientific Incorporated
• Inventors: Hochman, Mark N.
• Primary Examiner(s): Mahmood, Nadia A
• Application Number:
  US15/141,231
• Publication Number:
  US 20170106163A1
• Time in Patent Office: 1,041 Days
• Field of Search: 607 46
• CPC Class Codes: A61B 2090/0807 Indication means
• CPC Class Codes: A61B 2090/366 using projection of images directly onto the body
• CPC Class Codes: A61B 5/4896 Epidural space
• CPC Class Codes: A61M 19/00 Local anaesthesia syringes therefor A61M5/00; Hypothermia A61M5/42 takes precedence; cooling blood in a bypass of the arterial system A61M1/36
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 2230/60 Muscle strain, i.e. measured on the user
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36017 : with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36031 : using physiological parameters for adjustment
• CPC Class Codes: A61N 1/3605 : Implantable neurostimulators for stimulating central or peripheral nerve system

Abstract

A system for infusing medication into a mammalian subject is provided. The system includes an injection system for controlling a flow of fluid from a fluid reservoir to a needle. A sensor is provided that detects a characteristic indicative of the fluid pressure in the needle. The injection system controls the flow of fluid to the needle in response to the characteristic detected by the sensor and the sensor continuously detects the characteristic as the needle is inserted into the subject. The system further includes a conductive element for providing electric nerve stimulation, wherein the system provides electric nerve stimulation in response to the sensor detecting a pressure exceeding an upper limit.

Claims

1. An apparatus for administering fluid into an anatomic space, comprising:

an injection system for controlling a flow of fluid from a fluid reservoir to a needle, wherein the needle is configured for subcutaneous insertion into a mammalian subject;

a sensor for detecting a characteristic indicative of the fluid pressure in the needle, wherein the sensor is configured to continuously to detect the characteristic as the needle is inserted into the subject; and

an electric nerve stimulation element for providing an electric nerve stimulation at or adjacent to a tip of the needle;

wherein the electric nerve stimulation element provides electric nerve stimulation to a patient after the sensor detects a characteristic of the fluid pressure indicative of the fluid pressure exceeding an upper threshold.

2. The apparatus of claim 1 wherein the system includes an indicator operable to provide an audible, visual or tactile signal.

3. The apparatus of claim 2 wherein the indicator is operable to provide a signal when the fluid pressure exceeds the upper threshold.

4. The apparatus of claim 2 comprising an input element configured to provide a mechanism for an operator to input whether a clinically observable response was observed in response to the electric nerve stimulation.

5. The apparatus of claim 4 wherein the indicator is operable to provide a signal indicative of the needle being in an appropriate position for an injection, wherein the indicator is configured to provide the signal in response to a signal from the input element indicative of no clinically observable response being observed.

6. The apparatus of claim 1 wherein the injection system includes a fluid reservoir and an elongated flexible tube, wherein a first end of the flexible tube is connected with the fluid reservoir and a second end of the flexible tube is connected with the needle.

7. The apparatus of claim 6 wherein the sensor is located in-line between the fluid reservoir and the needle so that the sensor detects the fluid pressure in-line with the flow of fluid between the reservoir and the needle.

8. The apparatus of claim 1 wherein the injection system comprises a microprocessor for controlling the rate of fluid flowing from the fluid reservoir.

9. A method for providing a peripheral nerve block to a patient, comprising the steps of:

inserting a needle into a patient;

providing a flow of fluid through the needle while the needle is in the patient;

monitoring the fluid pressure in the needle while the needle is in the patient;

providing a human perceptible signal indicative of the fluid pressure exceeding an upper limit; and

providing an electric nerve stimulation at or adjacent to a tip of the needle in response to the signal.

10. The method of claim 9 comprising the step of monitoring the patient to detect a response to the electric nerve stimulation.

11. The method of claim 10 comprising the step of providing a first signal if a response to the electric nerve stimulation is detected or providing a second signal if no response to the electric nerve stimulation is detected.

12. The method of claim 11 comprising the step of re-positioning the needle in response to the first signal.

13. The method of claim 12 comprising the step of injecting a bolus of fluid in response to the second signal.

14. A system for providing a peripheral nerve block to a patient, comprising:

a needle having a sharpened tip;

a fluid pump providing a flow of fluid to the needle, wherein the fluid pump comprises a microprocessor for controlling the flow of fluid to the needle;

a sensor for detecting the fluid pressure in the needle;

a conductive element for providing an electric nerve stimulation at the tip of the needle; and

an output element configured to provide a human perceptible signal wherein in response to a signal indicative of the fluid pressure exceeding an upper limit the output element provides an alert signal to alert the operator to discontinue insertion of the needle;

wherein the conductive element is configured to provide an electric nerve stimulation at or adjacent to the tip of the needle after the sensor detects a fluid pressure exceeding the upper limit.

15. The system of claim 14 comprising an input element configured to allow the operator to indicate whether a clinically observable response was observed in response to the electric nerve stimulation.

16. The system of claim 15 wherein the output element is configured to provide a second alert signal in response to a signal from the input element indicating that a response was observed in response to the electric nerve stimulation.

17. The system of claim 16 wherein the output element is configured to provide a third alert signal in response to a signal from the input element indicating that no response was observed in response to the electric nerve stimulation.

18. The system of claim 14 wherein the fluid reservoir comprises a syringe having a plunger and the injection system comprises a control mechanism for automatically advancing the plunger to expel fluid from the syringe.

19. The system of claim 14 wherein the sensor comprises a pressure transducer.

20. The system of claim 19 wherein the sensor detects fluid pressure and the pump controls the flow of fluid in response to the detected fluid pressure.