Device and method for identification of a target region

• US 9,504,790 B1
• Filed: 02/23/2016
• Issued: 11/29/2016
• Est. Priority Date: 02/23/2016
• Status: Active Grant

• Current Assignee: Milestone Scientific Incorporated
• Original Assignee: Milestone Scientific Incorporated
• Inventors: Hochman, Mark N.
• Primary Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US15/050,681
• Time in Patent Office: 280 Days
• US Class Current: 1/1
• 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 2090/0807 Indication means
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 5/4896 Epidural space
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• 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 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons
• 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

Abstract

A method and apparatus are provided for locating a target region which is situated in a body of a subject, for example for the delivery of drugs. The system cooperates with a reservoir for receiving an injection fluid, a needle in fluid communication with the reservoir, and a sensor operable to detect a characteristic indicative of the fluid pressure in the needle. A signal generator supplies a success signal to an operator that indicates when the needle is present in the target region. A central controller controls the signal generator in response to signals received from the sensor.

Claims

1. An apparatus for locating a target region which is situated in a body of a subject, comprising:

a reservoir for receiving an injection fluid, wherein the reservoir comprises a connector for connecting the reservoir with a needle to be inserted into the body of the subject;

a sensor for detecting a characteristic indicative of the fluid pressure in the needle;

signal generator for supplying a true loss of pressure signal to an operator that indicates when the needle is present in the target region, wherein the true loss of pressure signal is acoustic, visual or tactile;

a fluid controller configured to control the flow of fluid from the reservoir;

a central controller connected with the sensor for receiving signals from the sensor and differentiating between a false loss of pressure and a true loss of pressure indicative of the needle being placed in a target area of interest, wherein the central controller is operable to control the signal generator;

wherein the central controller differentiates between a false loss of pressure and a true loss of pressure by declaring a true loss of pressure only if two required conditions are both met, wherein the two required conditions are;

(i) receipt of a signal from the sensor indicative of a first pressure threshold being exceeded; and

(ii) receipt of a subsequent signal from the sensor indicative of the pressure falling below a second pressure threshold;

wherein in response to determining a true loss of pressure, the central controller controls the signal generator to provide the true loss of pressure signal.

2. The apparatus of claim 1 wherein the first pressure threshold is characteristic of a barrier tissue which must be encountered by the needle prior to arriving at the target region and the second pressure threshold is characteristic of the target region and the second threshold is lower than the first pressure threshold.

3. The apparatus of claim 1 wherein the reservoir comprises a syringe barrel and the fluid controller comprises a syringe plunger.

4. The apparatus of claim 1 wherein the central controller is configured to control the fluid controller in response to signals received from the sensor.

5. The apparatus of claim 4 wherein the central controller is configured to control the fluid controller to stop the flow of fluid in response to receipt of a signal indicative of the first pressure threshold being exceeded.

6. The apparatus of claim 1 wherein the central controller is configured to control the signal generator to provide a second signal as long as the central controller receives a signal from the sensor indicative of the first pressure threshold being exceeded.

7. The apparatus of claim 1 wherein the central controller is configured to require a third condition in order to control the signal generator to provide the success signal, wherein the third condition is receipt of the subsequent signal for a time period exceeding a threshold.

8. The apparatus of claim 1 wherein the success signal is audible.

9. The apparatus of claim 1 wherein the sensor comprises a pressure transducer for generating a real time pressure signal corresponding to an instantaneous pressure at the point of the needle.

10. An apparatus for locating a target region which is a fluid-filled anatomic space situated in a body of a subject, wherein a barrier tissue is pierced to access the anatomic space, wherein the apparatus is configured to cooperate with a reservoir for receiving an injection fluid, a needle in fluid communication with the reservoir, and a sensor operable to detect a characteristic indicative of the fluid pressure in the needle, wherein the apparatus comprises;

a signal generator for supplying a success signal to an operator that indicates when the needle is present in the target region, wherein the success signal is acoustic, visual or tactile; and

a central controller operable to control the signal generator in response to signals received from the sensor;

wherein the central controller is operable to control the signal generator to provide the success signal if three required conditions are met, wherein the three requirements are;

(i) receipt of a signal from the sensor indicative of a first pressure threshold being exceeded;

(ii) receipt of a signal from the sensor indicative of the pressure falling below a second pressure threshold after the first pressure threshold has already been exceeded; and

(iii) receipt of one or more signals from the sensor indicative of the pressure remaining below the second pressure threshold for a time period that is greater than one second.

11. The apparatus of claim 10 comprising a connector for electrically connecting the central controller with the sensor.

12. The apparatus of claim 11 comprising a fluid controller that is operable to control the flow of fluid from the reservoir, wherein the central controller is configured to provide signals to the fluid controller to control the fluid controller.

13. The apparatus of claim 10 wherein the central controller is operable to control the flow of fluid from the reservoir in response to signals received from the sensor.

14. The apparatus of claim 10 wherein the first pressure threshold is characteristic of the barrier tissue which must be encountered by the needle prior to arriving at the target region and the second pressure threshold is characteristic of the target region and the second threshold is lower than the first pressure threshold.

15. The apparatus of claim 10 wherein the reservoir comprises a syringe barrel and the fluid controller comprises a syringe plunger.

16. The apparatus of claim 10 wherein the central controller is configured to control the fluid controller in response to signals received from the sensor.

17. The apparatus of claim 16 wherein the central controller is configured to control the fluid controller to stop the flow of fluid in response to receipt of a signal indicative of the first pressure threshold being exceeded.

18. The apparatus of claim 10 wherein the central controller is configured to control the signal generator to provide a second signal as long as the central controller receives a signal from the sensor indicative of the first pressure threshold being exceeded.

19. The apparatus of claim 10 wherein the time period is 3-5 seconds.

20. The apparatus of claim 10 wherein the success signal is audible.

21. The apparatus of claim 10 wherein the sensor comprises a pressure transducer for generating a real time pressure signal corresponding to an instantaneous pressure at the point of the needle.

22. An apparatus for locating a target region which is a fluid-filled anatomic space situated in a body of a subject, wherein a barrier tissue is pierced to access the anatomic space, wherein the apparatus is configured to cooperate with a reservoir for receiving an injection fluid, a needle in fluid communication with the reservoir, and a sensor operable to detect a characteristic indicative of the fluid pressure in the needle, wherein the apparatus comprises;

a signal generator for supplying a plurality of signals to an operator in response to signals from the sensor, wherein the signals acoustic, visual or tactile; and

a central controller operable to control the signal generator in response to signals received from the sensor;

wherein the central controller is operable to control the signal generator to provide

(a) a first signal in response to receipt of a signal from the sensor indicative of pressure below a first threshold;

(b) a second signal in response to receipt of a signal from the sensor indicative of pressure above the first threshold;

(c) a third signal in response to receipt of a signal from the sensor indicative of the pressure falling below a second threshold after receiving a signal from the sensor indicative of the pressure exceeding the first threshold.

23. The apparatus of claim 22 wherein the central controller is operable to control the signal generator so that:

the first signal is invariable as the pressure varies as long as the pressure remains below the first threshold;

the second signal is invariable as the pressure varies as long as the pressure remains above the first threshold; and

the third signal is invariable as the pressure varies as long as the pressure remains below the second threshold.

24. The apparatus of claim 22 wherein the signal generator is operable to provide a first alert signal when the central controller receives a signal from the sensor that the pressure first exceeds the first threshold.

25. The apparatus of claim 24 wherein the signal generator is operable to provide a second alert signal when the central controller receives a signal from the sensor that the pressure first falls below the second threshold after first exceeding the first threshold.

26. An apparatus for locating a target region which is situated in a body of a subject, comprising:

a reservoir for receiving an injection fluid, wherein the reservoir comprises a connector for connecting the reservoir with a needle to be inserted into the body of the subject;

a sensor for detecting a characteristic indicative of the fluid pressure in the needle;

signal generator for supplying a true loss of pressure signal to an operator that indicates when the needle is present in the target region, wherein the true loss of pressure signal is acoustic, visual or tactile;

a central controller connected with the sensor for receiving signals from the sensor and differentiating between a false loss of pressure and a true loss of pressure indicative of the needle being placed in a target area of interest, wherein the central controller is operable to control the signal generator;

wherein the central controller differentiates between a false loss of pressure and a true loss of pressure by declaring a true loss of pressure only if three required conditions are met, wherein the three required conditions are;

(i) receipt of a signal from the sensor indicative of a first pressure threshold being exceeded;

(ii) receipt of a subsequent signal from the sensor indicative of the pressure falling below a second pressure threshold; and

(iii) receipt of one or more signals from the sensor indicative of the pressure remaining below the second pressure threshold for a time period that is greater than one second.

27. The apparatus of claim 26 comprising a fluid controller for controlling the flow of fluid from the fluid reservoir, wherein the central controller is configured to control the fluid controller to stop the flow of fluid in response to receipt of a signal indicative of the first pressure threshold being exceeded.

28. The apparatus of claim 27 wherein the central controller is configured to control the signal generator to provide a second signal as long as the central controller receives a signal from the sensor indicative of the first pressure threshold being exceeded.

29. The apparatus of claim 26 wherein the sensor comprises a pressure transducer for generating a real time pressure signal corresponding to an instantaneous pressure at the point of the needle.