Drug infusion with pressure sensing and non-continuous flow for identification of and injection into fluid-filled anatomic spaces

• US 9,956,341 B2
• Filed: 07/03/2012
• Issued: 05/01/2018
• Est. Priority Date: 07/03/2012
• Status: Active Grant

• Current Assignee: Milestone Scientific Incorporated
• Original Assignee: Milestone Scientific Incorporated
• Inventors: Hockman, Mark N.
• Primary Examiner(s): FARRAR, LAUREN PENG
• Application Number:
  US13/540,880
• Publication Number:
  US 20140012226A1
• Time in Patent Office: 2,128 Days
• CPC Class Codes: A61B 5/032 Spinal fluid pressure
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• 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 2005/1588 having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6045 having complementary physical shapes for indexing or registration purposes
• CPC Class Codes: A61M 5/168 Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body flow control in general G05D7/00
• CPC Class Codes: A61M 5/178 Syringes
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

An automatic injection apparatus uses non-continuous fluid-flow of drugs to identify an intended injection site and includes a drive mechanism, a sensor and a controller for establishing fluid flow and pressure and preventing fluid flow until the pressure drops below a predetermined threshold. The pressure threshold is determined based on an internal pressure generated during an injection and more fluid will not flow until it drops below a predetermined pressure. An injection is performed to establish an initial pressure threshold and then to stop the fluid flow into a patient until the pressure drops below a predetermined pressure which allows fluid flow to resume, thus identifying a fluid filled tissue space. The initial pressure threshold is used as a control parameter to a microprocessor below which controls the rate of injection. Fluid flows below certain pressures are also used to identify a specific location within the body during injections.

Claims

1. An apparatus for administering fluid into a fluid-filled anatomic space capable of receiving fluid at a lower pressure than tissues surrounding the anatomic space, the apparatus comprising:

a disposables assembly comprising;

a syringe having a body for containing a fluid to be injected into the anatomic space, the syringe having a plunger movable in one end of the body for dispensing fluid from an opposite end of the body,

tubing permanently connected to the opposite end of the body,

a needle connected to the tubing and having a point insertable into a subject and movable through tissues surrounding the anatomic space, for seeking the anatomic space, and

an in-line pressure transducer for generating a signal corresponding to an instantaneous pressure at the point of the needle;

a drive unit mechanically connected to the syringe and electrically connected to the pressure transducer, the drive unit including

a controller with a computer, a memory for storing a first selected pressure (P1) that is selected to be compatible with injecting fluid into the fluid-filled anatomic space and a second selected pressure (P2) that is below the first selected pressure (P1) by a first selected amount,

a motor connected to and controlled by the computer, and

a syringe armature connected to the motor and mechanically connected to the syringe for moving the plunger into and out of the body for respectively injecting and aspirating fluid at the point of the needle for injecting and aspirating fluid into and out of the subject; and

the computer being programmed to control the motor to move the plunger to provide fluid flow into the subject until the first selected pressure (P1) is detected by the pressure transducer at which time the motor is stopped to stop the flow of fluid to the subject until the instantaneous pressure at the point of the needle drops below the second selected pressure (P2), at which time the program resumes operation of the motor to resume fluid flow to the subject, so that as the needle is moved in tissues of the subject surrounding the fluid-filled anatomic space, fluid flow to the tissues stops at instantaneous pressures above the first selected pressure (P1) and resumes when the instantaneous pressure falls below the second selected pressure to then resume injecting fluid into the anatomic space.

2. The apparatus of claim 1 wherein the memory also stores a third selected pressure (P3) that is below the first selected pressure (P1) and above the second selected pressure (P2), the computer being programmed to again stop operation of the motor to stop moving the plunger to again stop flow of fluid to the needle point when the instantaneous pressure rises to the third selected pressure (P3) after having reached the second selected pressure (P2).

3. The apparatus of claim 2, wherein said controller has an input for receiving a plurality of parameters including at least one of the first, second and third selected pressures (P1, P2, P3).

4. The apparatus of claim 2, wherein said third selected pressure (P3) is between about 80 to about 180 mm/Hg depending the anatomic space, the first selected pressure (P1) being about 80 to about 300 mm/Hg depending on the anatomic space and the second selected pressure (P2) being about 20 to about 100 mm/Hg depending the anatomic space.

5. The apparatus of claim 1, wherein said controller has an input for receiving at least one parameter including at least the first selected pressure (P1).

6. The apparatus of claim 5, wherein said at least one parameter is selected from the group consisting:

of injection tubing length;

injection tubing bore;

injection fluid viscosity;

injection fluid composition; and

injection fluid temperature.

7. The apparatus of claim 1, wherein said first selected pressure (P1) is between about 25 mm/Hg and about 300 mm/Hg.

8. The apparatus of claim 1, wherein said second selected pressure (P2) is between about 25 mm/Hg and about 100 mm/Hg.

9. The apparatus of claim 1, wherein said pressure transducer is permanently connected in-line at the connection between the opposite end of the syringe and the tubing.

10. The apparatus of claim 1, wherein said drive unit has a housing with a syringe cavity for removably holding the body of the syringe in an axially fixed position on the housing, and a plunger recess wherein the plunger is free to move, the syringe armature having a stage movable along the plunger recess, the plunger having thumb pad and the stage having at least one pivotally mounted and spring-loaded hook for engaging the thumb pad when the stage is moved to engage the thumb pad to axially connect the stage to the thumb pad so that movement of the stage in opposite directions moves the plunger in opposite directions, the syringe armature including a sensor for sensing that the stage has been moved to engage the thumb pad, the computer being programmed to stop the movement of the stage under the influence of the sensor when the stage has engaged the thumb pad.

11. The apparatus of claim 1, including a proprietary connector, electrically and mechanically connected between the pressure transducer and the controller for allowing operation of the controller only if an authorized disposable assembly is connected to the pressure transducer.

12. The apparatus of claim 1, wherein said needle point is adapted for insertion into one of:

an epidural tissue space;

an intra-articular space;

an intra-occular fluid of a globe of an eye;

an vessel of the body; and

a tissue space comprised primarily of bodily fluids.

13. The apparatus of claim 12, wherein said needle is a catheter needle.

14. The apparatus of claim 1, wherein said injection fluid comprises a drug.

15. The apparatus of claim 1, wherein said apparatus further comprises a visual signal, under the control of said controller, wherein said visual signal indicates each time said flow rate starts or stops.

16. The apparatus of claim 1, wherein said controller further comprises an audible signal generator under the control of said controller, wherein said audible signal generator generates an audible indication each time the fluid flow starts or stops.

17. The apparatus of claim 1, wherein said disposables assembly includes a rigid and elongated handle permanently connected to the tubing, and for connection to the needle, the handle having a length of about 10 to 20 cm.

18. An apparatus for administering medical fluids to an anatomical area 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;

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, wherein the central controller is operable to control the fluid controller in response to signals received from the sensor;

wherein the fluid controller is operable to control the flow of fluid to provide fluid flow in response to receiving a first signal from the central controller and wherein the fluid controller continues to provide fluid flow until receiving a signal from the central controller indicative of the sensor detecting a pressure at or above a first threshold;

wherein upon the fluid controller receiving a signal from the central controller indicative of the sensor detecting a pressure at or above the first threshold, the fluid controller is configured to terminate the flow of fluid from the reservoir and maintain the termination of the fluid flow until the sensor detects a pressure at or below a second threshold that is lower than the first threshold;

wherein upon the fluid controller receiving a signal from the central controller indicative of the sensor detecting a pressure at or below the second threshold, the fluid controller is configured to resume the fluid flow from the reservoir;

wherein fluid may be injected from the fluid reservoir when the needle enters the anatomical area.

19. The apparatus of claim 18 wherein the controller is configured so that after the pressure falls below the second threshold and the fluid controller receives a signal from the central controller indicative of the sensor detecting a pressure at or above a third threshold, the fluid controller is configured to terminate the flow of fluid from the reservoir, wherein the third threshold is lower than the first threshold.

20. The apparatus of claim 19 wherein the third pressure (P3) is less than the first pressure (P1) and greater than the second pressure (P2).

21. The apparatus of claim 18 wherein the fluid controller comprises a plunger displaceable within the reservoir and a drive element for displacing the plunger.

22. The apparatus of claim 21 wherein the drive element comprises a motor and operation of the motor is controlled in response to signals from the central controller.

23. The apparatus of claim 18 wherein the needle is part of a needle set comprising a length of tubing having a first end and a second end, wherein the needle is connected to the second end of the need and the first end of the tubing is connected with the sensor, wherein a proprietary connection between the electrical sensor and the central controller impedes interconnection of a needle set unless the needle set is an authorized needle set having pre-determined characteristics.

24. The apparatus of claim 18 comprising a first electrical connection connected with the electrical sensor and a second electrical connection connected with the central controller, such that connecting the first electrical connection with the second electrical connection transmits an authorization signal to the central controller, wherein the fluid controller will not operate unless the central controller receives the authorization signal.

25. The apparatus of claim 24 comprising an electrical circuit configured to generate the authentication signal.

26. The apparatus of claim 25 wherein the electrical circuit comprises a computer chip or memory chip.

27. The apparatus of claim 25 wherein the needle is part of a needle set comprising a length of tubing having a first end and a second end, wherein the needle is connected to the second end of the need and the first end of the tubing is connected with the sensor, wherein the authentication signal includes data regarding a physical characteristic of the needle set.