Programmable medical drug delivery systems and methods for delivery of multiple fluids and concentrations

• US 20050277912A1
• Filed: 07/19/2004
• Published: 12/15/2005
• Est. Priority Date: 07/16/2003
• Status: Active Grant

• Current Assignee: Sasha John
• Original Assignee: Sasha John
• Inventors: John, Sasha
• Granted Patent: US 7,811,279 B2
• Time in Patent Office: Days
• US Class Current: 604/890.100
• 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 mixing various drugs in an optimally controlled manner, for using flow controllers to guide multiple drugs into a single or into multiple catheters, for enabling a single lumen catheter to treat a specific region with several drugs, for allowing for dilution of a concentrated drug in order to both increase the time between refilling and also for providing any concentration of a drug that might be desired, for using a buffer fluid to deliver exact amounts of several drugs from the same catheter or to separate several drugs within a single catheter, for using external fluid present in the human body either as a diluent or buffer fluid, and for providing for a drug testing/filler apparatus to be used prior to implant to ensure proper function and easy means of filling multiple reservoirs with different fluids, and also after implant for refilling operations. The drug delivery system (DDS) can perform both bolus and continuous delivery of substances, and enable the measured delivery of any one of several drugs to one or more distal locations at independently programmable rates. New types of catheter systems and uses therefore are also described. Catheter hub assemblies allowing for easy replacement of drug delivery systems offer advantages when replacing drug delivery systems. New methods for using the DDS in the promotion of healthy pregnancy and treatment of a developing fetus are also possible.

Claims

1. An implantable drug delivery device for controlling a dispensing of a fluid drug to an internal target site of a patient, the device comprising:

a first reservoir for storing a first fluid;

an input port in fluid communication with the first reservoir;

an output port in fluid communication with the first reservoir;

a flow control system for controlling the transfer of the first fluid between the respective ports and the first reservoir, the flow control system having at least one flow controller; and

a flow control module for directing the at least one flow controller to direct the flow of the first fluid between a selected one of the ports and the first reservoir.

2. The device of claim 1 further comprising a second reservoir for storing a second fluid having a fluid attribute dissimilar from the first fluid.

3. The device of claim 1, wherein the fluid attribute is selected from the group comprising:

drug concentration;

drug type;

a diluent; and

a buffer solution.

4. The device of claim 3, wherein the second reservoir is adapted to store the diluent.

5. The device of claim 3, wherein the diluent is selected from the group comprising:

an inert substance in relation to the first fluid;

a saline solution; and

another drug different from the first fluid.

6. The device of claim 4 further comprising a diluent input port coupled directly to the second reservoir for supplying diluent taken from the patient, the fluid communication of the diluent input port with the patient being controlled by the flow control module.

7. The device of claim 2 further comprising the flow control system having a plurality of the flow controllers.

8. The device of claim 7, wherein the flow controller is selected from the group comprising:

valves and pumps.

9. The device of claim 7 further comprising a mixing chamber positioned between the reservoirs and the output port and in fluid communication with the reservoirs and the ports, the mixing chamber for mixing selected amounts of the first fluid and the second fluid prior to delivery to the output port.

10. The device of claim 7, wherein the flow control module directs the flow controllers of the flow control system to coordinate the transfer to the mixing chamber of measured amounts of the first fluid and the second fluid from their respective reservoirs.

11. The device of claim 9 further comprising the mixing chamber containing at least one of the following:

at least said flow controller for controlling the flow of fluids between said reservoirs and said mixing chamber, and at least one said flow controller for controlling the flow of fluids from said mixing chamber into said output port.

12. The device of claim 9, wherein the diluent is used to adjust the concentration of the first fluid to a desired drug concentration by being mixed with the first fluid in the mixing chamber.

13. The device of claim 3, wherein the second reservoir contains the buffer solution used to pump by the flow controller the first fluid supplied from the first reservoir through at least one catheter connected to the output port.

14. The device of claim 2, wherein the flow control module is preprogrammed to coordinate the operation of a plurality of the flow controllers for the reservoirs and the output port so as to direct a selected one of the first and second fluids into the output port and to inhibit flow of selected fluid from the output port into the reservoirs.

15. The device of claim 9, wherein said mixing chamber has a mixing flow controller for actively changing the volume of the chamber and thereby configuring the chamber fluid pressure to be approximately similar to the fluid pressure exerted by fluid from outside said mixing chamber.

16. The device of claim 7 further comprising a mixing chamber in fluid communication with the reservoirs and the ports, wherein the volume of the mixing chamber is variable such that the fluids contained within the mixing chamber are mixed while inhibiting fluid output from the output port.

17. The device of claim 1 further having an operational mode programmed in the flow control module, the mode selected from the group comprising;

a Sequential Bolus mode,

a flow-return mode,

a implantee replenishment mode,

a fill mode,

a sample-push mode,

a filter mode,

a purging mode, and

a shunt mode.

18. The device of claim 17, wherein for the sequential Bolus mode a drug is pushed through the length of a catheter by a buffer fluid.

19. The device of claim 17, wherein for the flow return mode a residual fluid which remains in a catheter after drug delivery is returned to at least one of the following:

the reservoir from which it originally resided, the mixing chamber, and other areas of the drug delivery system such as the mixing chamber.

20. The device of claim 17, wherein for the replenishment mode fluid from outside of the body is drawn into the drug-delivery system to serve as a drug, buffer fluid or as the diluent.

21. A catheter assembly for directing a selected fluid to at least one target site of a patient, the assembly comprising:

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.

22. The assembly of claim 21 further comprising the flow control system having a plurality of the directional flow controllers.

23. The assembly of claim 22, wherein the flow controllers are each responsive to the control signals from the drug delivery device.

24. The assembly of claim 23, 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.

25. The assembly of claim 23, 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.

26. The assembly of claim 22, wherein the plurality of the directional flow controllers further comprises a first directional flow controller and a second directional flow controller.

27. The assembly of claim 26, 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.

28. The assembly of claim 26, 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.

29. The assembly of claim 21, 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.

30. The assembly of claim 21, 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.

31. The assembly of claim 21 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.

32. The assembly of claim 21, 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.

33. A method of outputting by a catheter assembly a selected fluid to a target site of a patient, the catheter assembly having a first lumen and a second lumen adapted for fluid communication therebetween and a flow control system for directing inter-lumen fluid flow between the first and second lumens and for directing output fluid flow from the distal ends of the lumens to the target site, the method comprising the steps of:

delivering into the catheter at least two fluids, one of which is a buffer fluid, such that an alternating sequence of the fluids resides in the lumens;

configuring by the flow control system the fluid flow of the lumens for inter-lumen fluid flow and inhibiting fluid flow output from the lumens;

operating a pump in fluid communication with the lumens to perform inter-lumen circulation on the fluid sequence within the lumens until a selected one of the fluids resides near the distal tip of the first lumen;

configuring by the flow control system to inhibit the inter-lumen fluid flow and to enable output fluid flow from the distal end of the first lumen of the selected fluid; and

pumping the selected fluid as the output fluid from the first lumen.

34. An apparatus for configuring a drug delivery device, the device including at least one fluid reservoir in fluid communication with a fluid output port and a fluid input port and at least one fluid flow controller for controlling fluid input and output with respect to the fluid reservoir, the apparatus comprising;

a fluid input component for recording an amount value of input fluid directed to the input port of the device from a fluid source;

a flow control component for coupling to the device to configure the fluid flow controller to direct the input fluid from the input port into the fluid reservoir;

a sensor component for recording at least one operational state value of the device including a fill state value of the reservoir; and

a processor component for accepting user input commands and for coordinating the operation of the input, control, and sensor components in response to the user input commands;

wherein the recorded values are provided to the user of the apparatus.

35. The apparatus of claim 34 further comprising a fluid output component for recording an amount value of output fluid directed from the output port of the device.

36. The apparatus of claim 35, wherein the processor component compares the empirical recorded values of the device to stored manufacturer specifications of the device to determine actual operational characteristics of the device.

37. The apparatus of claim 36 further comprising a database coupled to the processor component, the database for storing the determined actual operational characteristics of the device.

38. The apparatus of claim 37, wherein the processor component coordinates an iterative adjustment of the device operation using the actual operational characteristics until an error of output fluid delivered from the output port is reduced to a predetermined error limit.

39. The apparatus of claim 38, wherein the flow control component is adapted to configure a plurality of the device flow controllers to direct a plurality of different input fluids from respective ones of the fluid sources to respective ones of the fluid reservoirs of the device.

40. The apparatus of claim 34 further including at least one of the following:

at least one viewing chamber adapted to permit an operator to see the output fluid contents of a catheter when connected to the output port of the device;

at least one sensor coupled to the sensor component and adapted to permit sensing of characteristics of the output fluid contents of a catheter when connected to the output port of the device;

at least one sensor coupled to the sensor component and adapted to permit sensing of characteristics of the input fluid directed to the input port of the device;

a source of one or more colored dyes and a mixer for enabling the dyes to mix with the input fluid prior to reaching the input port;

a source of one or more chemicals and a mixer for enabling the chemicals to mix with the input fluid prior to reaching the input port;

a source of one or more drugs in powder form and a mixer for enabling the drugs in powder form to mix with the input fluid to obtain the input fluid containing a drug of a specified concentration prior to reaching the input port of the device;

a source of one or more diluents and a mixer for enabling the diluents to mix with the input fluid to obtain the input fluid containing a drug of a specified concentration prior to reaching the input port of the device;

the fluid source containing a buffer fluid for providing the buffer fluid as the input fluid to the device;

the fluid source containing the input fluid characterized by a color, chemical composition, concentration or other physical parameter which may be sensed by a sensor coupled to the sensor component; and

a filled tank sufficiently dimensioned to submerge the device and any attached catheters.

41. The apparatus of claim 34, wherein the components are selected from the group comprising:

software;

hardware; and

a combination of hardware and software.

42. The apparatus of claim 34, wherein the sensor component is coupled to at least one sensor adapted to permit sensing of at least one of the following characteristics;

flow rate, flow volume, pressure, color, ph, a chemical substance, the concentration of a chemical substance, gas and air.

43. The apparatus of claim 34, wherein the flow control component assigns a positive pressure to the input fluid directed to the input port and assigns a corresponding negative pressure to the fluid reservoir that is created by the flow controller of the device, the positive pressure and negative pressure are approximately equal.