Method and apparatus for compensating for injection media viscosity in a pressurized drug injection system

• US 9,795,733 B2
• Filed: 08/10/2016
• Issued: 10/24/2017
• Est. Priority Date: 12/29/2008
• Status: Expired due to Fees

• Current Assignee: Astora Women's Health Holdings LLC (Endo International PLC)
• Original Assignee: Astora Women's Health Holdings LLC (Endo International PLC)
• Inventors: Rykhus, Robert L., Crank, Justin M.
• Primary Examiner(s): Schmidt, Emily
• Assistant Examiner(s): PENG, LAUREN MICHELE
• Application Number:
  US15/233,040
• Publication Number:
  US 20160367749A1
• Time in Patent Office: 440 Days
• 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. A method of determining a flow rate of a fluid in a needleless injection system, wherein the system comprises:

a console comprising control components for the injection system;

an injection chamber operatively connected to the console and comprising an injection cylinder and at least a first sensor,

a plunger positioned for slideable movement within the injection cylinder; and

an injection shaft operatively connected to the injection chamber, the injection shaft comprising a distal end and at least one injection orifice at the distal end for delivering a first fluid and a second fluid at a pressure, velocity, and stream size that corresponds to its viscosity for passing through a tissue surface, penetrating into tissue below the tissue surface, and dispersing fluid particles within the tissue, the method comprising the steps of;

providing the 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 first sensor;

providing the first speed of the plunger detected by the first sensor to the console;

calculating the flow rate of the first fluid; and

controlling pressure generated in the injection chamber by the console for fluid administration of at least one of the first and second fluids from the injection orifice at the distal end of the injection shaft at an injection speed that corresponds to a viscosity of at least one of the first and second fluids.

2. The method of claim 1, 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 the second fluid.

3. The method of claim 2, wherein the first fluid has a different viscosity than a viscosity of the second fluid.

4. The method of claim 2, wherein the first fluid comprises at least one material property that is different from that material property of the second fluid.

5. The method of claim 1, further comprising the steps of:

providing the 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 first sensor;

providing the second speed of the plunger detected by the first sensor to the console; and

calculating the flow rate of the second fluid.

6. The method of claim 5, further comprising the step of comparing the flow rate of the first fluid to the flow rate of the second fluid.

7. A needleless injection system comprising:

a console comprising control components for the system;

an injection chamber removeably attached to the console and comprising at least a first speed sensor for detecting fluid speed; 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;

wherein the injection chamber further comprises a plunger that is moveable within the injection cylinder in response to pressure changes within the injection cylinder; and

wherein pressure generated in the injection chamber is controllable by the console for administration of fluids from a distal end of the injection shaft at an injection speed that corresponds to viscosities of the respective fluids as determined by the console.

8. The needleless injection system of claim 7, 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.

9. The injection system of claim 7, wherein the first injection shaft is removeably attached to the injection chamber.

10. The injection system of claim 9 in combination with at least a second injection shaft that is removeably attachable to the injection chamber after detaching the first injection shaft.

11. The injection system of claim 10, wherein the first and second injection shafts comprise different distal end features.