Devices and Methods for Modulating Medium Delivery

• US 20140066891A1
• Filed: 03/15/2013
• Published: 03/06/2014
• Est. Priority Date: 08/28/2012
• Status: Active Grant

• Current Assignee: Osprey Medical, Inc.
• Original Assignee: Osprey Medical, Inc.
• Inventors: Burns, Matthew M., Doan, Tuan M., Houfburg, Rodney L., Kaye, David M., Mans, Daniel R., Mortier, Todd J.
• Granted Patent: US 9,320,846 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61M 2025/0076 Unidirectional valves
• CPC Class Codes: A61M 2039/2413 designed to reduce and or shut-off the flow when a certain maximum flow limit is exceeded
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3337 Controlling, regulating pressure or flow by means of a valve by-passing a pump
• CPC Class Codes: A61M 2205/3341 stabilising pressure or flow to avoid excessive variation
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 2206/22 eliminating pulsatile flows, e.g. by the provision of a dampening chamber
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 2210/127 Aorta
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14212 Pumping with an aspiration and an expulsion action
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28
• 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 5/482 : Varying injection pressure, e.g. by varying speed of injection
• CPC Class Codes: A61M 5/484 : Regulating injection pressure
• CPC Class Codes: A61M 5/488 : Limiting injection pressure
• CPC Class Codes: F04B 11/0033 : with a mechanical spring
• CPC Class Codes: G16H 20/10 : relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection

Abstract

Devices, systems and methods for controlling, regulating, altering, transforming or otherwise modulating the delivery of a substance to a delivery site. The devices, systems and methods optimize the delivery of the substance to an intended site, such as a vessel, vascular bed, organ and/or other corporeal structures, while reducing inadvertent introduction or reflux substance to other vessels, vascular beds, organs, and/or other structures, including systemic introduction.

Claims

1. A system to control, regulate, alter, transform or otherwise modulate the fluid delivery of medium injected to a body site, comprising:

an injector for injecting the medium;

a delivery catheter comprising a conduit for delivering the medium from outside of the body to a delivery site within the body; and

a modulator disposed between the injector and the delivery catheter, the modulator comprising;

a medium reservoir, the reservoir including a chamber for receiving medium therein and at least one surface within the chamber capable of imparting a constant force on medium within the chamber; and

a manifold having a manifold lumen therethrough, wherein the manifold lumen includes a first medium port fluidly coupled to the injector, a second medium port fluidly coupled to the chamber of the medium reservoir, and a third medium port fluidly coupled to the delivery catheter.

2. The system of claim 1 wherein the constant force is imparted such that the medium in the chamber is subjected to a constant pressure force that establishes a predetermined maximum pressure value for the fluid medium in the system.

3. The system of claim 1, and further comprising a flow control valve between the injector and the modulator.

4. The system of claim 1, and further comprising a flow control valve between the medium reservoir and the delivery catheter.

5. The system of claim 4 wherein the flow control valve is on the manifold.

6. The system of claim 1 wherein the fluid medium pressure in the delivery catheter is a function of force applied to the medium in the system by the injector and by the medium reservoir.

7. The system of claim 1 wherein the fluid medium pressure has a predetermined maximum pressure value.

8. The system of claim 1 wherein the fluid characteristic of the fluid medium in the delivery catheter are affected by the modulator while fluid medium flows from the injector to the delivery catheter.

9. The system of claim 1 wherein the medium reservoir further comprises a weight disposed relative to the at least one surface within the chamber to urge the surface against the fluid medium within the chamber.

10. The system of claim 1 wherein the medium reservoir further comprises a constant force spring disposed relative to the at least one surface within the chamber to urge the surface against the fluid medium within the chamber.

11. The system of claim 1 wherein the medium reservoir functions as a capacitive pressure reservoir for the fluid medium in the system, either accepting medium from the injector or discharging medium into the system, at least during medium flow throughout the system.

12. The system of claim 1 wherein the modulator further comprises a one-way valve disposed between the manifold and the delivery catheter, said one-way valve capable of ceasing medium delivery to the delivery catheter when a minimal pressure is not maintained.

13. A system for the modulation of the fluid characteristics of a fluid medium to a delivery site within a body, the system comprising:

a delivery catheter having a lumen and capable of delivering a medium from outside the body to the delivery site within the body;

an injector capable of being activated to provide fluid medium to the delivery catheter; and

a modulator disposed between the injector and the delivery catheter, wherein the modulator establishes, during the provision of the fluid medium to the delivery catheter, a pre-determined maximum pressure value for the fluid medium being provided to the delivery catheter.

14. A system for the modulation of pressure of a fluid medium, the system comprising:

an injector for injecting the medium;

a delivery catheter for delivering the medium from outside a body to a delivery site within the body; and

a modulator disposed between the injector and the delivery catheter, the modulator comprising;

a medium chamber in fluid communication with the injector and the delivery catheter, wherein the chamber is capable of acting as a pressure capacitor for the medium, being charged in the first instance by medium flowing from the injector into the chamber, and discharged in the second instance by fluid flowing from the chamber into the delivery catheter or the injector, and wherein the chamber includes a surface therein that imparts a constant pressure force on medium within the chamber.

15. The system of claim 14 wherein the medium chamber further comprises a weight disposed relative to the surface therein to urge the surface against the fluid medium in the chamber.

16. The system of claim 14 wherein the medium chamber further comprises a constant force spring disposed relative to the surface therein to urge the surface against the fluid medium in the chamber.

17. A method for controlling, regulating, altering, transforming or otherwise modulating the fluid delivery of medium to a selected site in a patient, the method comprising:

establishing a desired flow rate through a delivery catheter for the fluid medium to be delivered at the selected site;

employing a modulating mechanism disposed between a medium injector and said delivery catheter, said modulating mechanism capable of;

minimizing the time necessary to achieve the desired flow rate at the selected site;

maintaining the desired flow rate at the selected site for a selected time interval; and

minimizing the time necessary to stop the desired flow rate after the selected time interval.

18. The method of claim 17 wherein the desired flow rate is a function of opacity of the fluid medium.

19. The method of claim 17 wherein the desired flow rate is a function of a sensed parameter of the patient.

20. The method of claim 17 wherein a length of the selected time interval is a function of a sensed parameter of the patient.

21. The method of claim 17 wherein minimizing the time necessary to stop the desired flow rate is further enhanced with a modulating mechanism comprising a one-way valve.

22. A method for modulation of a fluid medium to a delivery catheter, said delivery catheter capable of delivering the medium from outside a patient to a site within the patient, the method comprising:

establishing a desired flow rate for the fluid medium within the catheter at the selected site;

delivering fluid medium to the delivery catheter from a manual injector; and

simultaneously delivering fluid medium to the delivery catheter from a constant force chamber,

wherein a first pressure force exerted on the fluid medium by the manual injector varies, and

wherein a second pressure force exerted on the fluid medium by the constant force chamber is constant at the predetermined value, where that value is a function of the desired flow rate.

23. A method for modulation of a fluid medium to a delivery catheter at a selected site in a patient, the method comprising:

establishing a desired flow rate for the fluid medium within the catheter at the selected site;

delivering fluid medium to the catheter from a manual injector;

delivering fluid medium to the catheter from a constant force chamber; and

preventing a pressure of fluid medium in the delivery catheter delivered from either the manual injector or the constant force chamber from exceeding a maximum pre-determined pressure.