Medical drug delivery systems and methods for delivery of multiple fluids and concentrations

• US 9,919,102 B2
• Filed: 11/02/2013
• Issued: 03/20/2018
• Est. Priority Date: 07/16/2003
• Status: Active Grant

• Current Assignee: Michael Sasha John
• Original Assignee: Michael Sasha John
• Inventors: John, Michael Sasha
• Primary Examiner(s): Mendez, Manuel
• Application Number:
  US14/070,522
• Publication Number:
  US 20150018758A1
• Time in Patent Office: 1,599 Days
• Field of Search: 604 65- 67, 604131, 604151, 128DIG 12, 128 13, 128 1
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 5/1408 in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16809 by repeated filling and emptying of an intermediate volume pressure infusion using positive displacement pumps A61M5/142
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

A drug delivery system provides for controlled mixing of drugs, using flow controllers to guide drugs into single or multiple catheters, enabling a single lumen catheter to dispense multiple drugs, diluting a concentrated drug to provide varying drug concentration, using a buffer fluid to deliver precise amounts of drug or to separate drugs within a catheter, and using a patient'"'"'s bodily fluid as a diluent or buffer fluid. A drug testing/filler apparatus may be used prior to system use to facilitate filling of multiple reservoirs and may also be used for refilling. The system can provide bolus or continuous delivery and enable the measured delivery of drug to selected distal locations at independent rates. New types of catheter systems, catheter hub assemblies, and uses therefore are also described. New methods for promotion of healthy pregnancy and treatment of a developing fetus are disclosed.

Claims

1. A drug delivery system for delivering a drug into a patient, the apparatus comprising:

an implantable drug pump having at least one drug reservoir filled with a drug and pumping means, the drug pump further configured to be operated jointly with a catheter assembly in order to provide controlled delivery of said drug to said catheter assembly;

a catheter assembly configured for operating in conjunction with the implantable drug pump and for providing circular flow of a therapeutic fluid therethrough, the therapeutic fluid comprising a first volume of a fluid and a drug contained therein;

a flow controller under control of the implantable drug pump for controlling a flow rate of the therapeutic fluid within the catheter assembly; and

a distal catheter member configured for operating to selectively permit;

the therapeutic fluid to do at least one of the following selected from the group of;

a) circulate, and b) be dispensed to a predetermined location in the patient.

2. The drug delivery system of claim 1, wherein the catheter assembly comprises:

a first lumen having a first proximal end for coupling to a drug delivery device and a first distal end for positioning at the target site;

a second lumen having a second proximal end for coupling to the drug delivery device and a second distal end for positioning at the target site, the first lumen and the second lumen adapted for fluid communication therebetween;

a flow control system positioned at the first and second distal ends for directing inter-lumen fluid flow between the first and second lumens and for directing output fluid flow from the distal ends to the target site, the flow control system having at least one directional flow controller adapted to receive at least one control signal from the drug delivery device.

3. The assembly of claim 2 further comprising the flow control system having a plurality of the directional flow controllers.

4. The assembly of claim 3, wherein the flow controllers are each responsive to the control signals from the drug delivery device.

5. The assembly of claim 4, wherein the control signals configure the plurality of the flow controllers in an output flow open state and an inter-lumen flow closed state, such that inter-lumen fluid flow is inhibited and output fluid flow is enabled from at least one of the lumens.

6. The assembly of claim 4, wherein the control signals configure the plurality of the flow controllers in an output flow closed state and an inter-lumen flow open state, such that output fluid flow is inhibited and inter-lumen fluid flow is enabled between the lumens.

7. The assembly of claim 3, wherein the plurality of the directional flow controllers further comprises a first directional flow controller and a second directional flow controller.

8. The assembly of claim 7, wherein the open state of the first directional flow controller provides for inter-lumen fluid flow simultaneously with the closed state of the second directional flow controller inhibiting the output fluid flow.

9. The assembly of claim 7, wherein the first directional flow controller is associated with the first lumen and the second directional flow controller is associated with the second lumen, such that the first and second flow controllers cooperate to inhibit respective output fluid flow from each of the lumens while providing for inter-lumen fluid flow.

10. The assembly of claim 2, wherein the first lumen and the second lumen are selected from the group comprising:

a dual lumen catheter; and

individual segments of a single lumen catheter.

11. The assembly of claim 2, which additionally includes at least one of the following:

a pump in fluid communication with the lumens and the drug delivery device and configured to accomplish at least one of the following;

to pump fluid from the drug delivery device into either of the two lumens, to pump fluid out of either of the two lumens and into the drug delivery device, and to circulate fluids within the lumens; and

a sensor for sensing at least one physical property of at least one fluid, said property including at least one of the following, a color, a chemical, a concentration.

12. The assembly of claim 2 wherein the assembly is part of a multi-stage catheter and wherein a second catheter is attached to the distal end of the lumens and receives the fluid from the flow control system causing said fluid to flow through said second catheter prior to delivery to said patient.

13. The assembly of claim 2, wherein said flow control system incorporates at least one of the following:

a pump, a second drug delivery device which is realized within a microchip, and sensors.

14. The drug delivery system of claim 1 wherein the fluid is fluid endogenous to the patient.

15. The drug delivery system of claim 1 wherein the fluid is a diluent.

16. The drug delivery system of claim 1 wherein the fluid is a pusher fluid.

17. The drug delivery system of claim 1 wherein the catheter assembly comprises a closed loop of lumen defining at least one sealed channel.

18. The drug delivery system of claim 1 wherein the catheter assembly comprises a closed loop of lumen defining at least one sealed fluid circuit.

19. The drug delivery system of claim 1 wherein the catheter assembly comprises a double-lumen catheter.

20. The drug delivery system of claim 1 wherein concentration of the drug in the therapeutic fluid varies in different portions of the catheter assembly.