METHOD AND APPARATUS FOR COMPENSATING FOR INJECTION MEDIA VISCOSITY IN A PRESSURIZED DRUG INJECTION SYSTEM

• US 20110270216A1
• Filed: 12/04/2009
• Published: 11/03/2011
• Est. Priority Date: 12/29/2008
• Status: Active Grant

• Current Assignee: Astora Women's Health Holdings LLC (Endo International PLC), Kagan Binder PLLC
• Original Assignee: Astora Women's Health Holdings LLC (Endo International PLC)
• Inventors: Crank, Justin M., Rykhus, Robert L.
• Granted Patent: US 9,421,326 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61M 2205/3341 stabilising pressure or flow to avoid excessive variation
• CPC Class Codes: A61M 2205/70 with testing or calibration facilities
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons

Abstract

A needleless injection system is provided to deliver therapeutic fluids to an internal treatment site in a patient, where the system is pressurized and is capable of compensating for differences in injection media viscosity and mechanical system characteristics. In one aspect, a needleless therapeutic fluid injection system is provided that includes modular, interchangeable components. In particular, the system includes a console that generally includes the electronic and/or hydraulic control components for the system, an injection chamber, and a shaft or catheter tube.

Claims

1. An injection system for delivering at least one fluid to a treatment site, wherein the system is pressurized and is adjustable to compensate for differences in fluid viscosity.

2. The injection system of claim 1, wherein the injection system comprises a needleless injection device.

3. The injection system of claim 2, wherein the needleless injection device comprises a console, an injection chamber, and an elongate shaft having a distal end.

4. The injection system of claim 3, wherein the distal end of the shaft comprises at least one injection orifice, wherein at least one fluid is ejectable under pressure from the at least one injection orifice.

5. (canceled)

6. A needleless injection system comprising:

an injection chamber comprising at least one sensor; and

an applicator lumen extending from a distal end of the injection chamber;

wherein the at least one sensor is capable of detecting at least one property of the flow of an injection fluid that is contained within the injection chamber.

7. The needleless injection system of claim 6, wherein the injection chamber further comprises an injection cylinder, and wherein the at least one sensor is positioned for communication with the injection cylinder.

8. The needleless injection system of claim 6, wherein the injection chamber further comprises a plunger positioned for slideable movement within the injection cylinder, and wherein a speed of movement of the plunger relative to the injection cylinder is detectable by the at least one sensor.

9. The needleless injection system of claim 6, further comprising a control system, wherein data detected by the at least one sensor is transferable to the control system for calculation of the flow rate of the injection fluid.

10. (canceled)

11. A method of determining a flow rate of a fluid in a needleless injection system, wherein the system comprises:

a control system, an injection chamber comprising an injection cylinder, a plunger positioned for slideable movement within the injection cylinder, and at least one sensor; and

an injection shaft, wherein the at least one sensor is capable of detecting at least one property of the flow of an injection fluid, the method comprising the steps of;

providing a first fluid to the injection chamber;

pressurizing the first fluid to a first pressure;

moving the plunger relative to the injection chamber and evacuating at least a portion of the first fluid from the injection chamber while detecting a first speed of the plunger with the at least one sensor;

providing the first speed of the plunger detected by the at least one sensor to the control system;

calculating the flow rate of the first fluid.

12. The method of claim 11, further comprising the steps of:

using the flow rate of the first fluid to calculate an injection pressure required to achieve a predetermined velocity for a second fluid.

13. The method of claim 12, wherein the first fluid has a different viscosity than a viscosity of the second fluid.

14. The method of claim 12, wherein the first fluid comprises at least one material property that is different from that material property of the second fluid.

15. The method of claim 11, further comprising the steps of:

providing a second fluid to the injection chamber;

pressurizing the second fluid to a second pressure;

moving the plunger relative to the injection chamber and evacuating at least a portion of the second fluid from the injection chamber while detecting a second speed of the plunger with the at least one sensor;

providing the second speed of the plunger detected by the at least one sensor to the control system;

calculating the flow rate of the second fluid.

16. The method of claim 15, further comprising the step of comparing the flow rate of the first fluid to the flow rate of the second fluid.

17. A method of delivering fluid, comprising the steps of:

providing a needleless fluid delivery system comprising a console, an injection chamber operatively connected to the console, and a catheter tube extending at a proximal end from the injection chamber;

providing a first fluid to the injection chamber;

pressurizing the injection chamber to a first pressure to cause the first fluid to move from the injection chamber to the distal end of the catheter tube;

measuring the flow rate of the first fluid with at least one sensor as the first fluid moves from the injection chamber to the distal end of the catheter tube;

determining an injection pressure of the first fluid based on a flow rate required to achieve a desired injection depth for the first fluid;

adjusting the injection pressure of the first fluid until a desired setting for the first fluid is achieved;

and accessing a treatment location with a distal end of the catheter tube.

20. (canceled)

22. (canceled)

23. A needleless injection system comprising:

a console comprising control components for the system;

an injection chamber removeably attached to the console; and

a first injection shaft attached at a proximal end to the injection chamber for fluid communication with an injection cylinder of the injection chamber;

wherein the console controls the pressure that is generated in the injection chamber for fluid administration at a distal end of the injection shaft.

18. The needleless injection system of claims 23,

wherein the injection chamber is removeably attached to the console.

19. The needleless injection system of claim 18, wherein the injection chamber further comprises a plunger that is moveable within the injection cylinder in response to pressure changes within the injection cylinder.

21. The needleless injection system of claim 19, further comprising a quantity of fluid within the injection chamber, wherein the fluid within the injection chamber is isolated from the control components of the console.

24. The injection system of claim 23, wherein the first injection shaft is removeably attached to the injection chamber.

25. The injection system of claim 24 in combination with at least a second injection shaft that is removeably attachable to the injection chamber after detaching the first injection shaft.

26. The injection system of claim 25, wherein the first and second injection shafts comprise different distal end features.