Special purpose fluid dispenser with pre-filled reservoir

• US 8,287,521 B2
• Filed: 06/03/2009
• Issued: 10/16/2012
• Est. Priority Date: 10/15/2008
• Status: Active Grant

• Current Assignee: BioQ Pharma Incorporated
• Original Assignee: Bio Quiddity, Inc.
• Inventors: Kriesel, Marshall S., Kriesel, Joshua W., Thompson, Thomas N.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): MEDWAY, SCOTT J
• Application Number:
  US12/455,646
• Publication Number:
  US 20100094219A1
• Time in Patent Office: 1,231 Days
• Field of Search: 604/151, 604/9, 604/890.1, 604/134, 604/135, 604/136, 604/137, 604/138, 604/139, 604/140, 604/141, 604/142, 604/143, 604/153, 604/156, 604/164.02, 604/164.09, 604/30, 604/236, 604/537, 604/323
• US Class Current: 604/891.1
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2005/14272 for emergency, field or home use, e.g. self-contained kits to be carried by the doctor
• CPC Class Codes: A61M 2202/048 Anaesthetics see also A61M19/00
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 5/141 with capillaries for restricting fluid flow
• CPC Class Codes: A61M 5/1454 spring-actuated, e.g. by a clockwork
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28

Abstract

A compact, nonelectric fluid dispenser for use in controllably dispensing beneficial agents such as propofol and dexmedetomidine hydrochloride to patients. The dispenser includes a fluid flow control assembly that precisely controls the flow of the medicament solution to the patient and embodies a collapsible, pre-filled drug container that contains the beneficial agents to be delivered to the patient. The unit-dose fluid dispenser of the invention is presented in a sterile and aseptic manner, where the drug has been pre-filled in the system, so that the practitioner cannot mistakenly give the wrong drug to the patient. The dispenser uniquely provides a more efficient medicament delivery system for procedure rooms, such as the endoscopy center, so that a greater number of patients can be treated per day at a higher standard of care with increased profits for the healthcare provider.

Claims

1. A dispensing device for dispensing medicaments to a patient comprising:

(a) a device housing;

(b) a carriage assembly disposed within said device housing for movement between a first position and a second position;

(c) an aseptically filled collapsible container carried by said carriage assembly, said collapsible container being formed by a blow-fill-seal process and having a continuous laminate wall including a collapsible side wall, a pierceable top wall connected to said collapsible side wall;

(d) a stored energy means operably associated with said carriage assembly for moving said carriage assembly between said first and second positions, said stored energy means comprising a spring assembly operably associated with said carriage assembly for exerting a variable force on said carriage assembly, said spring assembly comprising a spring drum and a spring having an elongated strip portion, said strip portion being coiled about said spring drum in varying degrees of tightness and having a first end in engagement with said device housing and a second end in engagement with said carriage;

(e) an administration set, including an administration line interconnected with said collapsible container, said administration line comprising an extruded body portion having a plurality of elongated reinforcing filaments embedded there within;

(f) fluid flow control means carried by said device housing for controlling the flow of medicament from said collapsible container toward said administration line, said flow control means comprising dose control means for controlling the dose of medicament delivered to the patient and rate control means for controlling the rate of medicament flow from said collapsible reservoir toward said dose control means, said rate control means comprising selector means for selecting the rate of fluid flow between said collapsible container and said administration set and a rate control plate having a plurality of fluid flow channels interconnected with said collapsible container; and

(g) a bolus delivery assembly carried by said device housing and in communication with said administration set for delivering bolus doses of medicament to said administration set said bolus delivery assembly comprising a collapsible bolus container having a first portion of a first volume and second portion of a second lesser volume.

2. The variable force spring as defined in claim 1 in which said elongated strip portion of said spring assembly is constructed from metal and metal alloys selected from the group consisting of Al/Cu, Al/Mn, Al/Si, Al/Mg, Al/Mg/Si, Al/Zn, Pb/Sn/Sb, Sn/Sb/Cu, Al/Sb, Zn/Sb, In/Sb, Sb/Pb, Au/Cu, Ti/Al/Sn, Nb/Zr, Cr/Fe, Cu/Mn/Ni, Al/Ni/Co, Ni/Cu/Zn, Ni/Cr, Ni/Cu/Mn, Cu/Zn and Ni/Cu/Sn.

3. The dispensing device as defined in claim 1 in which said wall of said collapsible container comprises five laminates.

4. The dispensing device as defined in claim 1 further including operating means carried by said device housing for controlling fluid flow between said collapsible container and said rate control means, said operating means comprising a piercing member for piercing said top wall of said collapsible container.

5. The dispensing device as defined in claim 4 in which said bolus delivery assembly includes a first mechanism for collapsing said first portion of said collapsible bolus container and a second mechanism for collapsing said second portion of said collapsible bolus container.

6. The dispensing device as defined in claim 5 in which said first portion of said collapsible bolus container has a volume of between about 3 ml and about 6 ml in which said second portion of said collapsible bolus container has a volume of between about 0.5 ml and about 3 ml.

7. A dispensing device for dispensing a medicaments to a patient comprising:

(a) a device housing;

(b) a reservoir defining assembly carried by said device housing, said reservoir defining assembly including a collapsible reservoir having an inlet port and an outlet port;

(c) stored energy means carried by said device housing and operably associated with said reservoir defining assembly for collapsing said collapsible reservoir to expel fluid medicament therefrom, said stored energy means comprising a spring assembly operably associated with said reservoir defining assembly for exerting a variable force on said collapsible reservoir to controllably collapse said collapsible reservoir, said spring assembly comprising a spring drum and a spring having an elongated strip portion, said strip portion being coiled about said spring drum, said elongated strip portion of said spring assembly having a length and being provided with a plurality of apertures along its length; and

(d) fluid flow control means carried by said device housing for controlling the flow of medicament from said reservoir toward said patient, said flow control means comprising dose control means for controlling the dose of medicament delivered to the patient and rate control means for controlling the rate of medicament flow from said collapsible reservoir toward said dose control means.

8. A dispensing device for dispensing medicaments to a patient comprising:

(a) a device housing;

(b) a carriage assembly disposed within said device housing for movement between a first position and a second position;

(c) an aseptically filled collapsible container carried by said carriage assembly, said collapsible container being formed by a blow-fill-seal process and having a continuous wall including a collapsible side wall, a pierceable top wall connected to said collapsible side wall;

(d) a stored energy means operably associated with said carriage assembly for moving said carriage assembly between said first and second positions, said stored energy means comprising a spring assembly operably associated with said carriage assembly for exerting a variable force on said carriage assembly, said spring assembly comprising a spring drum and a spring having an elongated strip portion, said strip portion being coiled about said spring drum and having a first end in engagement with said device housing and a second end in engagement with said carriage, said elongated strip portion of said spring assembly having a length and being provided with a plurality of apertures along its length;

(e) an administration set, including an administration line interconnected with said collapsible container; and

(f) fluid flow control means carried by said device housing for controlling the flow of medicament from said collapsible container toward said administration line, said flow control means comprising dose control means for controlling the dose of medicament delivered to the patient and rate control means for controlling the rate of medicament flow from said collapsible reservoir toward said dose control means.

9. A dispensing device for dispensing medicaments to a patient comprising:

(a) a device housing;

(b) a carriage assembly disposed within said device housing for movement between a first position and a second position;

(c) an aseptically filled collapsible container carried by said carriage assembly, said collapsible container being formed by a blow-fill-seal process and having a continuous wall including a collapsible side wall, and a pierceable top wall connected to said collapsible side wall;

(d) a stored energy means operably associated with said carriage assembly for moving said carriage assembly between said first and second positions, said stored energy means comprising a spring assembly operably associated with said carriage assembly for exerting a variable force on said carriage assembly, said spring assembly comprising a spring drum and a spring having an elongated strip portion, said strip portion being coiled about said spring drum and having a first end in engagement with said device housing and a second end in engagement with said carriage;

(e) an administration set, including an administration line interconnected with said collapsible container;

(f) fluid flow control means carried by said device housing for controlling the flow of medicament from said collapsible container toward said administration line, said flow control means comprising dose control means for controlling the dose of medicament delivered to the patient and rate control means for controlling the rate of medicament flow from said collapsible reservoir toward said dose control means, said dose control means including dose selector means for selecting the medicament dose delivered to said administration line, said dose selector means comprising a selector housing carried by said device housing and a selector member rotatably carried by said selector housing; and

(g) locking means carried by said device housing for locking said carriage assembly in said first position.

10. The dispensing device as defined in claim 9 in which said rate control means includes selector means for selecting the rate of fluid flow between said collapsible container and said administration set and further includes a rate control plate having a plurality of fluid flow channels interconnected with said collapsible container.

11. The dispensing device as defined in claim 10 further including a bolus delivery assembly carried by said device housing and in communication with said administration set for delivering bolus doses of medicament to said administration set, said bolus delivery assembly comprising a collapsible bolus container having a first portion of a first volume and second portion of a second lesser volume.