Cassette assembly for syringe fill system

• US 10,010,483 B2
• Filed: 07/19/2016
• Issued: 07/03/2018
• Est. Priority Date: 08/20/2013
• Status: Active Grant

• Current Assignee: Anutra Medical Inc.
• Original Assignee: Anutra Medical Inc.
• Inventors: Davidian, Daniel K., Newnam, Scott G., Nichols, Eli B., Mosler, Theodore J.
• Primary Examiner(s): Maust, Timothy L
• Assistant Examiner(s): Schmid, Andrew
• Application Number:
  US15/214,432
• Publication Number:
  US 20160324724A1
• Time in Patent Office: 714 Days
• Field of Search: 141 2, 141 18, 141 25, 141 27, 141100, 141104, 141105, 141107, 141234, 141235, 141236, 141238, 141290, 141301, 141302
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2075 for external venting
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61J 1/22 with means for metering the amount of fluid
• CPC Class Codes: A61M 2202/048 Anaesthetics see also A61M19/00
• CPC Class Codes: A61M 2205/75 with filters
• CPC Class Codes: A61M 5/001 Apparatus specially adapted for cleaning or sterilising syringes or needles
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/2425 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/3137 Specially designed finger grip means, e.g. for easy manipulation of the syringe rod
• CPC Class Codes: A61M 5/31586 performed by rotationally moving or pivoted actuator, e.g. an injection lever or handle
• CPC Class Codes: A61M 5/31591 Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means
• CPC Class Codes: A61M 5/31593 Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
• CPC Class Codes: A61M 5/502 for blocking the piston

Abstract

A syringe fill system is described, which is useful for filling syringes for dental anesthetic applications. The system incorporates capability for “push-pull”, “pull-push”, “push-push”, and “pull-pull” modes of operation, for loading syringes with compositions comprising multiple fluid components. A syringe fillable by such syringe fill systems is described, providing haptic and audible feedback to a user, to aid in administering precise amounts of therapeutic compositions. Also disclosed are cassette assemblies for use in such syringe fill systems. Such cassette assemblies may be formed of plastic and elastomeric materials of construction, as disposable or single-use components of the syringe fill system.

Claims

1. A cassette assembly configured for removable installation in a housing in which is mounted a pusher arranged to exert downward pressure on a fluid supply container that is pressure-responsive to dispense fluid to the cassette assembly, the cassette assembly comprising:

a base manifold member including an elongate manifold flow passage;

multiple fluid feed inlets extending outwardly from the base manifold member and communicating with the elongate manifold flow passage via inlet passages containing check valves, the multiple fluid feed inlets being configured for engagement with respective fluid supply containers; and

a syringe coupling mounted on the base manifold member, in fluid flow communication with the elongate manifold flow passage to deliver fluid from the elongate manifold flow passage to a syringe when coupled to the syringe coupling;

the multiple fluid feed inlets comprising (i) a first fluid feed inlet configured for engagement with a first fluid supply container engageable with the pusher for push-dispensing a first fluid from the first fluid supply container to the elongate manifold flow passage, and (ii) a second fluid feed inlet configured for engagement with a second fluid supply container for pull-dispensing a second fluid from the second fluid supply container to the elongate manifold flow passage; and

a first check valve of the check valves, in the inlet passage of the first fluid feed inlet and a second check valve of the check valves, in the inlet passage of the second fluid feed inlet, said first check valve and said second check valve being configured to provide respectively different crack pressures enabling push-dispensing of the first fluid from the first fluid supply container under push-dispensing conditions involving exertion of pressure by the pusher on the first fluid supply container and pull-dispensing of the second fluid from the second fluid supply container under pull-dispensing conditions involving retraction of a plunger in a barrel of said syringe when coupled to the syringe coupling, to thereby cause suction to draw second fluid from the second fluid container into the elongate manifold flow passage so that the second fluid intermixes with the first fluid in the elongate manifold flow passage and purges the first fluid from the elongate manifold flow passage during syringe filling by retractive action of the plunger so that intermixed first and second fluids are drawn from the elongate manifold flow passage into the syringe during said syringe filling.

2. The cassette assembly of claim 1, wherein the first check valve for push dispensing of the first fluid from the first fluid supply container has a crack pressure that is in a range of from 6 to 20 psi, and the second check valve for pull dispensing of the second fluid from the second fluid supply container has a crack pressure that is in a range of from 0.5 to 10 psi, with the proviso that the crack pressure of the check valve for push dispensing is greater than the crack pressure of the check valve for pull dispensing.

5. The cassette assembly of claim 1, wherein the base manifold member comprises a manual gripping element configured to enable the cassette assembly to be removably installed in and removed from the housing.

6. The cassette assembly of claim 1, wherein the first fluid feed inlet is coupled with the first fluid supply container and the second fluid feed inlet is coupled with the second fluid supply container.

7. The cassette assembly of claim 6, wherein the first fluid supply container contains a buffering medium, and the second fluid supply container contains an anesthetic composition.

8. The cassette assembly of claim 7, wherein the buffering medium comprises sodium bicarbonate.

9. The cassette assembly of claim 7, wherein the anesthetic composition comprises lidocaine, articaine, or marcaine.

10. The cassette assembly of claim 1, wherein the multiple fluid feed inlets extend vertically upwardly from a top surface of the base manifold member.

11. The cassette assembly of claim 1, adapted as a single-use or disposable assembly.

12. The cassette assembly of claim 11, fabricated predominately of biodegradable plastic and elastomeric material(s) of construction.

13. The cassette assembly of claim 1, wherein the cassette assembly is comprised in a kit including a multiplicity of syringes each of which is adapted for coupling with the syringe coupling mounted on the base manifold member.

14. The cassette assembly of claim 7, wherein the buffering medium comprises sodium bicarbonate and the anesthetic composition comprises lidocaine.

15. The cassette assembly of claim 1, configured so that the pull-dispensing conditions involving retraction of the plunger of the syringe when coupled to the syringe coupling of the cassette assembly cause a pressure differential to be exerted on the second check valve for opening thereof.

17. A method of filling a syringe, comprising:

coupling the syringe to the syringe coupling of a cassette assembly according to claim 1;

dispensing first fluid from the first fluid supply container to the elongate manifold flow passage by push-dispensing of the first fluid from the first fluid supply container;

retracting a plunger of the syringe to induce the pull-dispensing of the second fluid from the second fluid supply container so that the second fluid intermixes with the first fluid in the elongate manifold flow passage to form a fluid mixture that is drawn into the syringe in which the plunger is being retracted, to at least partially fill the syringe.

18. The method of claim 17, wherein the second fluid purges the first fluid from the elongate manifold flow passage during syringe filling.

19. The method of claim 17, wherein the first fluid comprises a buffering medium, and the second fluid comprises an anesthetic composition.

20. The method of claim 19, wherein the buffering medium comprises sodium bicarbonate and the anesthetic composition comprises lidocaine.

3. A cassette assembly configured for removable installation in a housing in which is mounted a pusher arranged to exert downward pressure on a fluid supply container that is pressure-responsive to dispense fluid to the cassette assembly, the cassette assembly comprising:

a base manifold member including an elongate manifold flow passage;

multiple fluid feed inlets extending outwardly from the base manifold member and communicating with the elongate manifold flow passage via inlet passages containing check valves, the multiple fluid feed inlets being configured for engagement with respective fluid supply containers; and

a syringe coupling mounted on the base manifold member, in fluid flow communication with the elongate manifold flow passage to deliver fluid from the elongate manifold flow passage to a syringe when coupled to the syringe coupling;

the multiple fluid feed inlets comprising (i) a first fluid feed inlet configured for engagement with a first fluid supply container engageable with the pusher for push-dispensing a first fluid from the first fluid supply container to the elongate manifold flow passage, and (ii) a second fluid feed inlet configured for engagement with a second fluid supply container for pull-dispensing a second fluid from the second fluid supply container to the elongate manifold flow passage;

a first check valve of the check valves, in the inlet passage of the first fluid feed inlet and a second check valve of the check valves, in the inlet passage of the second fluid feed inlet, said first check valve and said second check valve being configured to provide respectively different crack pressures enabling push-dispensing of the first fluid from the first fluid supply container under push-dispensing conditions involving exertion of pressure by the pusher on the first fluid supply container and pull-dispensing of the second fluid from the second fluid supply container under pull-dispensing conditions so that the second fluid intermixes with the first fluid in the elongate manifold flow passage and purges the first fluid from the elongate manifold flow passage during syringe filling; and

a second fluid supply container adaptor coupled to the second fluid feed inlet and configured to receive the second fluid supply container including a pierceable cap or cover, the second fluid supply container adaptor comprising a piercing member for piercing the pierceable cap or cover, and an air inletting vent enabling air to enter the second fluid supply container to facilitate dispensing of fluid from the second fluid supply container.

4. The cassette assembly of claim 3, wherein the air inletting vent comprises a filter that is effective to remove airborne contaminants from air that enters the second fluid container to facilitate dispensing of fluid from the fluid supply container.

16. The cassette assembly of claim 3, configured so that the pull-dispensing conditions comprise retraction of a plunger of a syringe when coupled to the syringe coupling.