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

• US 8,591,498 B2
• Filed: 08/10/2010
• Issued: 11/26/2013
• 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 A
• Application Number:
  US12/853,941
• Publication Number:
  US 20100318025A1
• Time in Patent Office: 1,204 Days
• Field of Search: 604 65- 67, 604/131, 604/151, 604/890.1, 128/DIG.12, 128/DIG.13
• US Class Current: 604/890.1
• 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 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 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 processor 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 processor components in response to at least one of the at least one operational state value and the user input commands;

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

2. The apparatus of claim 1 further comprising a fluid output component for recording an amount value of output fluid directed from the output port of the device.

3. The apparatus of claim 2, 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.

4. The apparatus of claim 3 further comprising a database coupled to the processor component, the database for storing the determined actual operational characteristics of the device.

5. The apparatus of claim 4, 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.

6. The apparatus of claim 5, 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.

7. The apparatus of claim 1, wherein the components are selected from the group comprising:

software;

hardware; and

a combination of hardware and software.

8. The apparatus of claim 1, wherein the processor 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.

9. The apparatus of claim 1, 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.

10. The apparatus of claim 1 further including 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.

11. The apparatus of claim 1 further including at least one sensor coupled to the processor component and adapted to permit sensing of an operational state value of a characteristic of output fluid contents of a catheter when connected to the output port of the device.

12. The apparatus of claim 1 further including at least one sensor coupled to the processor component and adapted to permit sensing of an operational state value of a characteristic of the input fluid directed to the input port of the device.

13. The apparatus of claim 1 further including 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.

14. The apparatus of claim 1 further including 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.

15. The apparatus of claim 1 further including 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.

16. The apparatus of claim 1 further including 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.

17. The apparatus of claim 1 further including the fluid source containing a buffer fluid for providing the buffer fluid as the input fluid to the device.

18. The apparatus of claim 1 further including a 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 processor component.

19. The apparatus of claim 1 further including a filled tank sufficiently dimensioned to submerge the device and any attached catheters.