Syringe fill system and method

• US 10,010,482 B2
• Filed: 07/12/2016
• 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 C
• Application Number:
  US15/208,568
• Publication Number:
  US 20160317390A1
• Time in Patent Office: 721 Days
• Field of Search: 141302, 141301, 141290, 141 27, 141 25, 141238, 141236, 141235, 141234, 141 2, 141 18, 141107, 141105, 141104, 141100
• 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 syringe fill system, comprising:

a housing in which is mounted a pusher arranged to exert downward pressure on a first fluid supply package that is pressure-responsive to dispense fluid, the pusher being coupled with a track in the housing for bidirectional linear movement;

a selector and driver assembly operatively coupled with the pusher, arranged for user selection of an amount of a first fluid to be dispensed and responsive to the user selection to translate the pusher against the first fluid supply package for dispensing of the user-selected amount of the first fluid; and

a cassette assembly removably installable in the housing, and comprising a manifold adapted to receive fluid from the first fluid supply package, and configured for coupling with a second fluid supply package, and mixing of the first and second fluids to form a fluid mixture for syringe fill, the manifold including a syringe coupling engageable with a syringe coupling port in the housing, so as to allow a syringe to be coupled with the syringe coupling of the cassette assembly for the syringe fill,

wherein the syringe fill system is configured for push-pull dispensing of the first and second fluids, respectively, with push dispensing of the first fluid being effected by translation of the pusher against the first fluid supply package to dispense the user-selected amount of the first fluid to a flow passage in the manifold communicating with the syringe coupling port, and with pull dispensing of the second fluid being effected by retraction of a plunger in a barrel of a syringe coupled with the syringe coupling of the cassette assembly, to thereby cause suction to draw second fluid from the second fluid supply package into the flow passage in the manifold for said mixing of the first and second fluids to form the fluid mixture, with purging of the first fluid from the flow passage during syringe fill by retractive action of the plunger so that the fluid mixture is drawn from the flow passage into the syringe during the syringe fill.

2. The syringe fill system of claim 1, wherein the syringe coupling is configured with locking structure for locking the syringe in position for the syringe fill.

3. The syringe fill system of claim 1, wherein the syringe coupling is constructed and arranged for maintaining sterile conditions of a syringe coupled therewith.

4. The syringe fill system of claim 3, wherein the syringe coupling comprises a lockout feature for maintaining sterility of the syringe coupling when a syringe is not coupled to the syringe coupling of the cassette assembly for the syringe fill.

5. The syringe fill system of claim 1, comprising the first fluid supply package and the second fluid supply package disposed in the housing and arranged for fluid mixing in the manifold of the cassette assembly.

6. The syringe fill system of claim 5, wherein the first fluid supply package contains buffering medium, and the second fluid supply package contains an anesthetic for which the buffering medium is bufferingly effective.

7. The syringe fill system of claim 6, wherein the anesthetic comprises an aesthetic selected from the group consisting of lidocaine, articaine, and marcaine.

8. The syringe fill system of claim 1, further comprising check valves configured for the push-pull dispensing of the first and second fluids, respectively, the check valves comprising a first check valve arranged to control push dispensing of the first fluid, and a second check valve arranged to control pull dispensing of the second fluid, the first check valve having a crack pressure in a range of from 6 to 20 psi, and the second check valve having a crack pressure in a range of from 0.5 to 10 psi, with the proviso that the crack pressure of the first check valve is higher than the crack pressure of the second check valve.

9. The syringe fill system of claim 8, wherein the first fluid comprises buffering medium, and the second fluid comprises an anesthetic for which the buffering medium is bufferingly effective.

10. The syringe fill system of claim 9, wherein the anesthetic comprises an aesthetic selected from the group consisting of lidocaine, articaine, and marcaine.

11. A syringe fill system, comprising:

a housing in which is mounted a pusher arranged for push dispensing of fluid from a first fluid supply package;

a selector and driver assembly operatively coupled with the pusher, for push dispensing of a user-selected amount of the first fluid; and

a cassette assembly removably installable in the housing, and comprising a manifold adapted to receive fluid from the first fluid supply package, and configured for coupling with a second fluid supply package, and mixing of the first and second fluids to form a fluid mixture for syringe fill, the manifold including a syringe coupling for engaging a syringe and filling the syringe with the fluid mixture,

wherein the syringe fill system is configured for push-pull dispensing of the first and second fluids, respectively, with push dispensing of the first fluid being effected by translation of the pusher against the first fluid supply package to dispense the user-selected amount of the first fluid to a flow passage in the manifold communicating with the syringe coupling, and with pull dispensing of the second fluid being effected by retraction of a plunger in a barrel of a syringe coupled with the syringe coupling, to thereby cause suction to draw second fluid from the second fluid supply package into the flow passage in the manifold for said mixing of the first and second fluids to form the fluid mixture, with purging of the first fluid from the flow passage during syringe fill by retractive action of the plunger so that the fluid mixture is drawn from the flow passage into the syringe during the syringe fill.

12. The syringe fill system of claim 11, wherein the syringe coupling is configured with locking structure for locking the syringe in position for syringe filling.

13. The syringe fill system of claim 11, wherein the syringe coupling is constructed and arranged for maintaining sterile conditions of the syringe engaged therewith.

14. The syringe fill system of claim 13, wherein the syringe coupling comprises a lockout feature for maintaining sterility of the syringe coupling when a syringe is not engaged with the syringe coupling of the cassette assembly for syringe filling.

15. The syringe fill system of claim 11, comprising the first fluid supply package and the second fluid supply package disposed in the housing and arranged for fluid mixing in the manifold of the cassette assembly.

16. The syringe fill system of claim 15, wherein the first fluid supply package contains buffering medium, and the second fluid supply package contains an anesthetic for which the buffering medium is bufferingly effective.

17. The syringe fill system of claim 16, wherein the anesthetic comprises an aesthetic selected from the group consisting of lidocaine, articaine, and marcaine.

18. The syringe fill system of claim 11, further comprising check valves configured for the push-pull dispensing of the first and second fluids, respectively, the check valves comprising a first check valve arranged to control push dispensing of the first fluid, and a second check valve arranged to control pull dispensing of the second fluid, the first check valve having a crack pressure in a range of from 6 to 20 psi, and the second check valve having a crack pressure in a range of from 0.5 to 10 psi, with the proviso that the crack pressure of the first check valve is higher than the crack pressure of the second check valve.

19. The syringe fill system of claim 18, wherein the first fluid comprises buffering medium, and the second fluid comprises an anesthetic for which the buffering medium is bufferingly effective.

20. The syringe fill system of claim 19, wherein the anesthetic comprises an aesthetic selected from the group consisting of lidocaine, articaine, and marcaine.