Device and method for identification of a target region

• US 10,646,660 B1
• Filed: 05/16/2019
• Issued: 05/12/2020
• Est. Priority Date: 05/16/2019
• Status: Active Grant

• Current Assignee: Milestone Scientific Incorporated
• Original Assignee: Milestone Scientific Incorporated
• Inventors: Hochman, Mark N., Buck, Richard K.
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Zamory, Justin L
• Application Number:
  US16/414,499
• Time in Patent Office: 362 Days
• 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 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 5/032 Spinal fluid pressure
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/31588 electrically driven
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 25/065 Guide needles
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/1456 with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• 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 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/31573 Accuracy improving means
• CPC Class Codes: A61M 5/31576 Constructional features or modes of drive mechanisms for piston rods
• CPC Class Codes: A61M 5/48 having means for varying, regulating, indicating or limiting injection pressure A61M5/142 takes precedence ; monitoring pressure in infusion systems A61M5/16854
• CPC Class Codes: A61M 5/486 Indicating injection pressure

Abstract

A method and apparatus are provided for use in locating a target region which is situated in the body of a subject, for example for the delivery of drugs. The system includes an assembly for controlling the flow of fluid from a fluid reservoir to a conduit, such as a needle. A sensor detects a characteristic indicative of the fluid pressure in the conduit. The system processes data from the sensor to detect the presence of a pulsatile waveform. A controller may control further operation of the system based on information regarding the presence of the pulsatile waveform and features of the waveform, such as amplitude.

Claims

1. A needle-bearing apparatus for administering fluid into target location in a subject, comprising:

a fluid reservoir for storing fluid to be provided to a needle;

an ejection element displaceable relative to the fluid reservoir to expel fluid from the reservoir;

a drive element configured to engage the ejection element to control displacement of the ejection element;

a controller operable to control the drive element to control the flow of fluid from the reservoir to the needle;

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

a flexible conduit in fluid communication with the fluid reservoir and the sensor, wherein the conduit is substantially rigid radially;

a display including a first output section configured to display the fluid pressure at the needle as a function of time in a manner consistent with a guidance procedure;

wherein the controller is configured to periodically discontinue movement of the drive element and process data from the sensor to detect one or more characteristic indicative of a pulsatile waveform;

wherein the conduit, reservoir, ejection element and drive element are configured so that the fluid volume between the needle and the fluid reservoir is substantially constant so that the sensor is able to accurately detect the pulsatile waveform passing through residual fluid in the needle when movement of the drive element is discontinued;

wherein the controller is programmed to process data from the sensor to isolate data indicative of a pulsatile waveform;

wherein the display comprises a second output section configured to display the data indicative of a pulsatile waveform while the first section displays the fluid pressure data as a function of time in the first section.

2. The needle-bearing apparatus of claim 1 wherein the fluid reservoir is a syringe barrel.

3. The needle-bearing apparatus of claim 1 wherein the ejection element is slidably displaceable within the fluid reservoir.

4. The needle-bearing apparatus of claim 1 wherein the controller is configured to analyze the data from the sensor to detect one or more characteristics indicative of a loss of resistance.

5. The needle-bearing apparatus of claim 4 wherein in response to the controller detecting the one or more characteristics the controller is configured to discontinue movement of the drive element and process data from the sensor to detect one or more characteristic indicative of a pulsatile waveform.

6. The needle-bearing apparatus of claim 5 wherein the controller is configured to provide a verification signal that the needle is properly placed adjacent a target tissue upon receipt of a signal indicative of a loss of resistance and upon receipt of a signal indicative of the presence of a pulsatile waveform at the needle.

7. The needle-bearing apparatus of claim 1 comprising a display including a first output section configured to display the fluid pressure at the needle as a function of time in a manner consistent with a loss of resistance guidance procedure.

8. The needle-bearing apparatus of claim 7 wherein the controller is configured to process data from the sensor to isolate data indicative of a pulsatile waveform, wherein the display comprises a second output section configured to display the data indicative of a pulsatile waveform while the first section displays the fluid pressure data as a function of time in the first section.

9. The needle-bearing apparatus of claim 1 wherein the controller is configured to provide signals to guide insertion of the conduit wherein the signals are provided in response to the data from the sensor.

10. The needle-bearing apparatus of claim 1 wherein the system comprises an input mechanism for selectively varying an amplitude range for the processed data to attempt to identify a pulsatile waveform.

11. The needle-bearing apparatus of claim 1 wherein the conduit is a hollow needle having a sharpened tip.

12. The needle-bearing apparatus of claim 1 wherein the conduit is a catheter form a fluid-tight connection with the sensor.

13. An apparatus for administering fluid into target location in a subject, comprising:

a fluid reservoir for storing fluid to be provided to the needle;

an ejection element displaceable relative to the fluid reservoir to expel fluid from the reservoir;

a drive element configured to engage the ejection element to control displacement of the ejection element;

a controller operable to control the drive element to control the flow of fluid from the reservoir to the needle;

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

a flexible conduit in fluid communication with the fluid reservoir and the sensor;

a user interface comprising a display;

wherein the controller is programmed to display data on the user interface in a first format in which the fluid pressure sensed by the sensor is displayed as a function of time;

wherein the controller is programmed to process data from the sensor to isolate data indicative of a pulsatile waveform and wherein the controller is programmed to display the processed data on the user interface separate from the first format.

14. The apparatus of claim 13 comprising an input mechanism for selectively varying an amplitude range for the processed data to attempt to identify a pulsatile waveform.

15. An apparatus for administering fluid into target location in a subject, comprising:

a fluid reservoir for storing fluid to be provided to a needle;

an ejection element displaceable relative to the fluid reservoir to expel fluid from the reservoir;

a drive element configured to engage the ejection element to control displacement of the ejection element;

a controller operable to control the drive element to control the flow of fluid from the reservoir to the needle;

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

a flexible conduit in fluid communication with the fluid reservoir and the sensor;

an operator interface comprising a display;

wherein the controller is programmed to analyze data from the sensor to detect one or more characteristics indicative of a loss of resistance;

wherein in response to the controller detecting the one or more characteristics the controller is programmed to discontinue movement of the drive element and process data from the sensor to isolate data indicative of a pulsatile waveform;

and wherein the controller is programmed to display the processed data on the operator interface separate from the first format.

16. The apparatus of claim 15 wherein the controller is configured to provide a verification signal that the needle is properly placed adjacent a target tissue upon receipt of a signal indicative of a loss of resistance and upon receipt of a signal indicative of the presence of a pulsatile waveform at the needle.