Mixing syringe with and without flush

• US 7,101,354 B2
• Filed: 02/21/2006
• Issued: 09/05/2006
• Est. Priority Date: 05/03/2004
• Status: Expired due to Fees

• Current Assignee: Infusive Technologies, LLC (Element Global, Inc.)
• Original Assignee: Infusive Technologies, LLC (Element Global, Inc.)
• Inventors: Thorne, Gale H., Thorne, Gale H. Jr.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US11/359,304
• Publication Number:
  US 20060142701A1
• Time in Patent Office: 196 Days
• Field of Search: 604/191, 604/218, 604 89- 91, 604/184, 604/213, 604/226, 604/231, 604/237, 604/238, 604/523, 604/6.09
• US Class Current: 604/191
• CPC Class Codes: A61M 2005/3123 having air entrapping or venting means, e.g. purging channels in pistons
• CPC Class Codes: A61M 5/286 upon internal pressure increase, e.g. pierced or burst A61M5/283 takes precedence
• CPC Class Codes: A61M 5/31596 comprising means for injection of two or more media, e.g. by mixing

Abstract

A displaceable valved stopper is disclosed which partitions a conventional syringe into proximal and distal chambers to provide a multi-chamber, mixing syringe assembly. Also the valved stopper and a valve assembly are disclosed for use in a single conventional syringe to provide dual chamber mixing plus a disparate and sequentially dispensed flush. Incorporated in the valve assembly is another valved stopper and a separator which filters out gas from liquid being dispensed through the valve assembly. Each valved stopper is made as a single molded part which may be made from basic syringe plunger material. Also, each valved stopper may have a bi-state valve (e.g. a domed, slit valve). The separator is a single molded part which may be molded from basic syringe material. Each valve is actuated to a different state by differential pressure of a force greater than the associated valved stopper displacement force. A syringe plunger communicates through fluid in a more proximal chamber to force displacement of the valved stopper and valve assembly for both mixing and dispensing.

Claims

1. A mixing syringe apparatus for mixing and dispensing medical fluids, said apparatus comprising:

a syringe comprising a conventional hollow barrel having an elongated internal cylindrical surface, said barrel surface comprising an open proximal end and a distal end having a closed interior about an orifice through which fluid is transferred, and a stem and plunger combination, said combination being disposed to be displaced within said barrel by application of force in a predetermined direction against said stem thereby imposing predetermined differential pressures for displacing fluid within the barrel; and

a removable cap which, in combination with said plunger, fully confines all fluid and material previously stored within said syringe barrel between the plunger and cap;

a displaceable valved stopper disposed within said barrel between said plunger and said distal end to provide a more proximal chamber disposed between the plunger and valved stopper as a container for a first volume of matter and a more distal chamber disposed between the distal end and valved stopper as a container for a second volume of matter, said first and second volumes of matter being kept disparate before mixing and mixed by action of force directed in the predetermined direction upon the stem of the syringe;

said displaceable valved stopper comprising a normally-closed valve which yields to an open state when the predetermined pressure differential is disposed across the valved stopper, the pressure differential causing diluting matter in a fluid state to be dispensed through the valve, thereby to mix the diluting fluid from the dispensing chamber with matter resident in the receiving chamber;

an elastic fluid disposed within the more distal chamber for storing energy resulting from pressure derived from force applied in the predtermined direction upon the stem of the syringe, at least a portion of the stored energy effecting displacement of the valved stopper in a direction opposite direction of the applied predetermined force, once that force is terminated, thereby changing size of one chamber relative to the other chamber and providing opportunity for additional dispensing of fluid through the valve by subsequent application of force in the predetermined direction.

2. A mixing syringe apparatus according to claim 1, wherein said valve comprises structure for permitting the valve to operate in two different states wherein the valve is patent to flow in one direction in one state and patent to flow an opposite direction in the other state.

3. A mixing syringe apparatus according to claim 1, wherein said valve comprises a non-planar structure.

4. A mixing syringe apparatus according to claim 3, wherein said non-planar structure is a dome structure.

5. A mixing syringe apparatus according to claim 3, wherein said non-planar structure comprises a valve formed by a slit.

6. A mixing syringe apparatus according to claim 1 wherein said apparatus further comprises a biasing memory element disposed in place of the stem within the barrel of the syringe for the purpose of maintaining a differential pressure across the valved stopper to keep the valve closed during shipping, storage and before use.

7. A mixing syringe apparatus according to claim 1 further comprising a valve assembly disposed within the more proximal chamber to provide a middle chamber for the medical material and a most proximal chamber for a disparate solution which is delivered separately from mixed matter and diluting fluid.

8. A mixing syringe apparatus for mixing and dispensing medical fluids, said apparatus comprising:

a syringe comprising a conventional hollow barrel having an elongated internal cylindrical surface, said barrel surface comprising an open proximal end and a distal end having a closed interior about an orifice through which fluid is transferred, and a stem and plunger combination, said combination being disposed to be displaced within said barrel by application of force against said stem thereby imposing differential pressures for displacing fluid within the barrel; and

a removable cap which, in combination with said plunger, fully confines all fluid and material previously stored within said syringe barrel between the plunger and cap;

a displaceable valved stopper disposed within said barrel between said plunger and said distal end to provide a more proximal chamber disposed between the plunger and valved stopper as a container for a medical material and a more distal chamber disposed between the distal end and valved stopper as a container for a diluting fluid which is to be mixed with the first medical material;

said displaceable valved stopper comprising;

a switchable bi-state valve comprising two operating states, a first state in which said valve is closed to fluid flow when disposed away from said distal end and imposed upon by a non-negative differential pressure but which is permissive to proximally directed fluid flow when imposed upon by a negative differential pressure and a second state in which said valve is permissive to distally directed flow resulting from a positive pressure gradient, said valve further comprising switchable construction which is displaced to a second state upon application of a predetermined positive differential pressure across the valved stopper.

9. A mixing syringe apparatus according to claim 8, wherein said bi-state valve comprises a non-planar structure.

10. A mixing syringe apparatus according to claim 9, wherein said non-planar structure is a dome structure.

11. A mixing syringe apparatus according to claim 9, wherein said non-planar structure comprises a valve formed by a slit.

12. A mixing syringe apparatus according to claim 8 wherein said apparatus further comprises a biasing memory element disposed in place of the stem within the barrel of the syringe for the purpose of maintaining a positive differential pressure across the first valved stopper to keep the valve closed during shipping, storage and before use.

13. A mixing syringe apparatus according to claim 8 further comprising a valve assembly disposed within the more proximal chamber to provide a middle chamber for the medical material and a most proximal chamber for a disparate solution which is delivered separately from mixed medical material and diluting fluid.

14. A mixing syringe apparatus according to claim 13 wherein said valve assembly comprises a second valved stopper and a gas separator.

15. A method for using a mixing syringe apparatus for mixing and dispensing medical fluids comprising the following steps:

(a) providing a syringe comprising a conventional hollow barrel having an elongated internal cylindrical surface, said barrel surface comprising an open proximal end and a distal end having a closed interior about an orifice through which fluid is transferred, and a stem and plunger combination, said combination being disposed to be displaced within said barrel by application of force against said stem thereby imposing differential pressures for displacing fluid within the barrel;

(b) providing a removable cap which, in combination with said plunger, fully confines all fluid and material previously stored within said syringe barrel between the plunger and cap;

(c) providing a displaceable valved stopper disposed within said barrel between said plunger and said distal end to provide a more proximal chamber disposed between the plunger and valved stopper as a container for a medical material and a more distal chamber disposed between the distal end and valved stopper as a container for a diluting fluid which is to be mixed with the first medical material;

said displaceable valved stopper comprising;

a switchable bi-state valve comprising two operating states, a first state in which said valve is closed to fluid flow when disposed away from said distal end and imposed upon by a non-negative differential pressure but which is permissive to proximally directed fluid flow when imposed upon by a negative differential pressure and a second state in which said valve is permissive to distally directed flow resulting from a positive pressure gradient, said valve further comprising switchable construction which is displaced to a second state upon application of a predetermined positive differential pressure across the valved stopper;

(d) placing a force on said stem to displace said stem and plunger proximally from an original site relative to said barrel thereby opening the valve of the valved stopper and displacing a portion of the fluid in the more distal chamber into the more proximal chamber;

(e) releasing the force from the stem, thereby permitting the valve to close, the stem and plunger to be displaced to the original site and the valved stopper to be distally displaced;

(f) repeating steps (d) and (e) until substantially all of the fluid originally resident in the more distal chamber is displaced from the more distal chamber to mix with material in the more proximal chamber and the valved stopper is displaced to the distal end of the barrel surface.

16. The method for using a mixing syringe apparatus for mixing and dispensing medical fluids according to claim 15 comprising a further step of removing the cap from the syringe.

17. The method for using a mixing syringe apparatus for mixing and dispensing medical fluids according to claim 15 comprising a further step of applying a distally directed force upon the stem to exert a positive differential pressure across the valved stopper to switch the valve to the second state.

18. The method for using a mixing syringe apparatus for mixing and dispensing medical fluids according to claim 17 comprising a further step of continuing to apply distally directed force upon the stem to dispense fluid from the syringe.

19. The method for using a mixing syringe apparatus for mixing and dispensing medical fluids according to claim 15 comprising a further step of applying distally directed force upon the stem to switch the valve to the second state.

20. A method for using a mixing syringe apparatus for mixing and dispensing medical fluids according to claim 18 comprising a further steps of:

(g) continuing to apply distally directed force upon the stem to thereby open the valve and displace a portion of the mixed fluid in the more proximal chamber into the more distal chamber as the stem is displaced from an original site to a more distal site and

(h) removing distally directed force from the stem and permitting valve to close and the stem and plunger to be displaced by stored pressure gradients instituted by the distally directed force to the original site.

21. The method for using a mixing syringe apparatus for mixing and dispensing medical fluids according to claim 20 comprising the further steps of repeating steps (g) and (h) until substantially all fluid from the more proximal chamber is displaced into the more distal chamber and the valved stopper is displaced proximally to abut the plunger.

22. The method for using a mixing syringe apparatus for mixing and dispensing medical fluids according to claim 21 comprising the further steps of removing the cap and applying distally directed force to dispense fluid from the syringe.

23. A method for using a mixing syringe apparatus for mixing and dispensing medical fluids according to claim 15 comprising the additional step of installing a valve assembly to divide the more proximal chamber into a more proximal chamber and a most proximal chamber.

24. The method for using a mixing syringe apparatus for mixing and dispensing medical fluids according to claim 23 comprising the steps of mixing fluids in the more proximal chamber while keeping fluid in the most proximal chamber disparate from the mixed fluids.

25. The method for using a mixing syringe apparatus for mixing and dispensing medical fluids according to claim 24 comprising the steps of dispensing each fluid from the more proximal chamber and then the fluid from the most proximal chamber sequentially.

26. A mixing syringe apparatus for mixing and dispensing medical fluids, said apparatus comprising:

a syringe comprising a conventional hollow barrel having an elongated internal cylindrical surface, said barrel surface comprising an open proximal end and a distal end having a closed interior about an orifice through which fluid is transferred, and a stem and plunger combination, said combination being disposed to be displaced within said barrel by application of force against said stem thereby imposing differential pressures for displacing fluid within the barrel; and

a removable cap which, in combination with said plunger, fully confines all fluid and material previously stored within said syringe barrel between the plunger and cap;

a displaceable valved stopper disposed within said barrel between said plunger and said distal end to provide a more proximal chamber disposed between the plunger and valved stopper as a container for diluting fluid and a more distal chamber disposed between the distal end and valved stopper as a container for matter which is to be mixed and diluted with the diluent;

said displaceable valved stopper comprising;

a normally-closed valve;

said valve being disposed to open to permit flow of diluting fluid there through when imposed upon by a pre-determined non-zero positive differential pressure but which closes when a predetermined non-positive differential pressure is imposed in chambers surrounding the valved stopper whereby equilibrating pressure following a positive differential pressure disposed across the valved stopper closes the valve, imposes a momentary non-positive pressure differential upon the valved stopper and thereby displaces the valved stopper proximally.

27. The mixing syringe apparatus for mixing and dispensing medical fluids according to claim 26 further comprising a non-planar slit valve.

28. A method for using a mixing syringe apparatus for mixing and dispensing medical fluids comprising the following steps:

(a) providing a syringe comprising a conventional hollow barrel having an elongated internal cylindrical surface, said barrel surface comprising an open proximal end and a distal end having a closed interior about an orifice through which fluid is transferred, and a stem and plunger combination, said combination being disposed to be displaced within said barrel by application of force against said stem thereby imposing differential pressures for displacing fluid within the barrel;

(b) providing a removable cap which, in combination with said plunger, fully confines all fluid and material previously stored within said syringe barrel between the plunger and cap;

(c) providing a displaceable valved stopper disposed within said barrel between said plunger and said distal end to provide a more proximal chamber disposed between the plunger and valved stopper as a container for a diluting fluid and a more distal chamber disposed between the distal end and valved stopper as a container for a medical material which is to be mixed with the first medical material;

said displaceable valved stopper comprising;

a normally-closed valve;

said valve being disposed to open to permit flow of diluting fluid there through when imposed upon by a non-zero positive differential pressure but which closes when a non-positive differential pressure is imposed across the valved stopper whereby equilibrating pressure following a positive differential pressure disposed in chambers surrounding the valved stopper closes the valve, imposes a momentary non-positive pressure differential and thereby displaces the valved stopper proximally;

(d) placing a force on said stem to displace said stem and plunger distally from an original site relative to said barrel thereby opening the valve of the valved stopper and displacing a portion of the fluid in the more proximal chamber into the more distal chamber;

(e) releasing the force from the stem, thereby permitting the valve to close, the stem and plunger to be displaced to the original site and the valved stopper to be proximally displaced;

(f) repeating steps (d) and (e) until substantially all of the fluid originally resident in the more proximal chamber is displaced from the more proximal chamber to mix with material in the more distal chamber and the valved stopper is displaced to the abut the plunger.