Micro-volume infusion pump systems and methods of making the same

• US 20050191196A1
• Filed: 07/08/2004
• Published: 09/01/2005
• Est. Priority Date: 09/22/2000
• Status: Abandoned Application

• Current Assignee: David N. Jones, Howard M.C. Tanner, Royce Herbst, Stephen R. Topaz
• Original Assignee: David N. Jones, Howard M.C. Tanner, Royce Herbst, Stephen R. Topaz
• Inventors: Topaz, Stephen R., Jones, David N., Herbst, Royce, Tanner, Howard M.C.
• Application Number:
  US10/886,821
• Publication Number:
  US 20050191196A1
• Time in Patent Office: Days
• US Class Current: 417/477.2
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body

Abstract

An apparatus and method for volumetric micro-liter infusion of therapeutic liquids are disclosed. This portable pump system remains unobtrusive and less restrictive of patient ambulation and orientation. The present invention includes expendables, the disposability of which facilitates safe reuse of more expensive portions and is sufficiently simple for use in a home care environment. It may be designed to incorporate real-time, interactive or remote monitoring and regulation and visual or audible indication of system pressures, chemical balances and other important variables.

Claims

1. A method of manufacturing a mask work embodying an integral cavity configuration, comprising the steps of:

providing a mold plate assembly comprising a first face in which a desired cavity configuration with a periphery is formed, a second face for abutting said first face and at least one access point whereby negative or positive pressure from a source external to said mold plate may be applied to said desired cavity configuration;

providing a sheet of flexible polymer flat stock with a first exposure and a second exposure facing a direction opposite said first exposure;

placing at least a first portion of said flat stock between first side and a second side of said mold plate assembly with said first exposure abutting said first face and anchoring said first side and said second side together with said at least a first portion of flat stock remaining indwelling between said first side and said second side;

associating said mold plate assembly including said indwelling said at least a first portion of flat stock with said pressure source external;

heating said mold plate assembly and said indwelling said at least a first portion of flat stock to a degree sufficient to surmount a first memory characteristic of said flat stock;

applying selectively negative or positive pressure to said desired cavity configuration in sufficient degree to displace a part of said flat stock specifically into said cavity configuration;

cooling said flat stock to a degree sufficient to establish a second memory characteristic of said part of said flat stock displaced into and in conformity with said cavity configuration, such that said first exposure of said at least a first portion of said flat stock is formed to include a convex configuration corresponding to said cavity configuration and said second exposure is formed to include a concave configuration corresponding to said cavity configuration;

removing said at least a first portion of said flat stock from between said mold plate assembly and folding a second portion of said flat stock against said at least a first portion such that said second exposure of said at least a first portion is opposite to and lays against said second exposure of said second portion of said flat stock; and

bonding said at least a first portion of said flat stock and said second portion of flat stock together in close proximity to said periphery of said cavity configuration.

2. The method of claim 1, wherein bonding is accomplished by a dielectric weld.

3. The method of claim 2, wherein said dielectric weld forms a continuous seal along said entire periphery of said cavity configuration.

4. The method of claim 3, wherein said cavity configuration defines a fluid conduit for use in a cassette path of a disposable cartridge interface of a peristaltic pump.

5. The method of claim 4, wherein said cavity configuration further comprises at least one compartment structured and arranged to accommodate a fluid metering device.

6. The method of claim 4, wherein said cavity configuration further comprises at least one compartment structured and arranged to accommodate a pressure sensor.

7. The method of claim 6, wherein said pressure sensor is structured and arranged to communicate interactively with said peristaltic pump in response and relative to information provided by said pressure sensor and any preprogramming of said peristaltic pump.

8. The method of claim 1, wherein bonding is accomplished with a dielectric weld and forms a continuous seal along said entire periphery of said cavity configuration to define a fluid flow path, said fluid flow path including an upstream fluid opening and a downstream fluid opening, and wherein said bonding further comprises bonding said at least a first portion of said flat stock and said second portion of said flat stock together at or near an outer edge of said flat stock to define a bag portion space between said first exposure and said second exposure that is in communication with said upstream fluid opening but sealed against fluid flow in any other direction.

9. A portable pump system for volumetric micro-liter infusion of therapeutic fluid, including:

a pump mechanism;

a fluid conduit comprising an upstream conduit, a downstream conduit and an interface conduit associated with said pump mechanism for pumping fluid; and

a fluid metering system in fluid communication with said downstream conduit and comprising;

a plurality of valves;

a means of governing actuation of said plurality of valves in accordance with an information signal; and

a fluid restrictor stage including a plurality of possible fluid flows paths;

any one or combination or all of which may be selectively accessed or bypassed in accordance with actuation of any or all of said plurality of valves subject to said means of governing actuation.

10. The pump system of claim 9, whereby fluid flow may be further reduced to preselected micro-liter flow rates substantially lower than rates of flow achievable by said pump mechanism alone.

11. The pump system of claim 9, wherein a pressure sensor is associated with said downstream conduit upstream from said fluid restrictor stage, whereby pressure characteristics of said fluid in said downstream conduit upstream from said fluid restrictor stage may be ascertained to a more subtle degree thereby enabling inference of pressure characteristics of said fluid in said downstream conduit downstream from said fluid restrictor stage, said pressure sensor being in communication with said means of governing actuation.

12. The pump system of claim 11, wherein said pressure characteristics may include:

pressure status;

pressure change;

rate of pressure change;

or

any or all of the foregoing;

whereby said pressure sensor may communicate pressure characteristics to said means of governing actuation as a basis for said means of governing actuation to govern and coordinate actuation of said plurality of valves for achievement of optimal pump system performance in accordance with predetermined specifications.

13. A portable pump system for volumetric micro-liter infusion of therapeutic fluid, including:

a pump mechanism;

a fluid conduit comprising an upstream conduit, a downstream conduit and an interface conduit associated with said pump mechanism for pumping fluid; and

a signal processing feedback loop associated with said downstream conduit and comprising;

a means of governing the RPM rate of said pump mechanism in accordance with an information signal; and

a pressure transducer in communication with said means of governing, capable of ascertaining pressure characteristics of said fluid within said downstream conduit, and

capable of supplying to said means of governing said information signal pertaining to ascertained pressure characteristics.

14. The pump system of claim 13, whereby said means of governing actuation governing means are coordinated based upon said information signal to achieve either dynamic valving or dynamic metering or both dynamic valving and dynamic metering of fluid flow within said downstream conduit.

15. The pump system of claim 14, wherein said pressure transducer is a strain gauge capable of sensing mechanical movement by means of changes in an electrical signal from a micro circuit.

16. A portable acoustic streaming pump system for volumetric micro-liter infusion of therapeutic fluid, including:

a fluid conduit comprising an upstream conduit, a downstream conduit and an interface conduit;

a fluid chamber in communication with said fluid conduit; and

a piezoelectric material wafer associated with said fluid chamber and in communication with a source of electric current;

whereby said source of electric current may be introduced to said piezoelectric material wafer to cause a deflection of said piezoelectric material wafer repeatedly resulting in a fluid flow within said fluid conduit.

17. The pump system of claim 16, wherein fluid flow may be in communication with a pressure sensor or fluid metering means or both a pressure sensor and fluid metering means to achieve greater consistency and definition in dynamic fluid flow.