Multi-chamber, sequential dose dispensing syringe

• US 7,048,720 B1
• Filed: 11/22/2005
• Issued: 05/23/2006
• 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., Robinson, Bradley Carling, Howlett, Michael Wallace, San Juan, Nestor Rodriguez
• Primary Examiner(s): Kennedy, Sharon
• Application Number:
  US11/284,504
• Publication Number:
  US 20060100590A1
• Time in Patent Office: 182 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, 604/609
• US Class Current: 604/191
• CPC Class Codes: A61M 2005/1787 Syringes for sequential delivery of fluids, e.g. first medicament and then flushing liquid
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 5/284 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/285 with sealing means to be broken or opened
• 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 valve assembly is disclosed which partitions a conventional syringe into proximal and distal chambers to provide a multi-chamber, sequentially dispensing syringe apparatus. Incorporated in the valve assembly is a valved stopper having a valve (e.g. a slit valve) and a separator which filters out gas from liquid being dispensed through the valve assembly. A syringe plunger communicates through fluid in the proximal chamber to force displacement of the valve assembly. The valve is actuated by differential pressure of a force greater than the valve assembly displacement force. The valve assembly may be made from two parts: (1) a valved stopper (may be molded from basic syringe plunger material); (2) a separator (may be injection molded from syringe barrel material). Key features of such a multi-chamber syringe apparatus are (1) fluids in the chambers are kept disparate; (2) the valve assembly may be used in conventional syringes; (3) gas in a closed chamber is filtered from delivered liquid; (4) bi-stable operation of a valve assembly valve permits reflux free operation; (5) a clinch in the separator holds the valve securely closed until the valve is opened by a predetermined action, such action being tactilely sensible. A tubing set is disclosed which may be added to provide a third disparate chamber.

Claims

1. A multi-chamber syringe apparatus for sequentially dispensing medical fluids, said apparatus comprising:

a syringe barrel having an internal surface which is concentrically disposed about an elongated medial axis, said barrel surface comprising an open proximal end and a distal end having a closed interior about an orifice through which fluid is transferred;

a stem and plunger combination disposed to be displaced within said barrel by application of a directional force against said stem for dislocating fluid thereby; and

a valve assembly which, when disposed within said barrel between said plunger stopper and said distal end, provides a proximal chamber between the valve assembly and plunger stopper and a distal chamber between the valve assembly and said closed interior surface;

said valve assembly comprising;

a valved stopper comprising a normally closed, medially disposed valve in a distal face of the stopper and a hollow, grooved, cylindrical interior which opens proximally toward said plunger and which communicates with said plunger stopper via fluid, within the barrel, said valved stopper being distally displaced toward said distal end within said barrel when acted upon by a force directionally applied toward said distal end which produces a first differential pressure and being proximally displaced away from said distal end when acted upon by an oppositely directed force of a second differential pressure; and

said valved stopper further comprising structure which only opens said valve to permit fluid flow there through when said stopper is acted upon by force of a third differential pressure which is in the same direction as force from the first differential pressure, the magnitude of the third differential pressure being greater than the first differential pressure.

2. A multi-chamber syringe apparatus according to claim 1 wherein said valved stopper comprises a bi-stable valve.

3. A multi-chamber syringe apparatus according to claim 1 comprises a slit valve comprising a medially disposed slit valve.

4. A multi-chamber syringe apparatus according to claim 3 wherein said bi-stable valve comprises a non-planar structure.

5. A multi-chamber syringe apparatus according to claim 4 wherein said non-planar valve comprises structure which defines operation of said valve to be bi-stable such that, once opened, said valve remains open.

6. A multi-chamber syringe apparatus according to claim 5 wherein said valved stopper further comprises a hinge disposed about said valve structure which articulates about said valve structure to permit the valve to be displaced to an open state when acted upon by force of said third differential pressure and to retain the valve in the open state, once opened.

7. A multi-chamber syringe apparatus according to claim 5 wherein said non-planar valve structure comprises a hemispherical dome shape.

8. A multi-chamber syringe apparatus according to claim 7 wherein said valved stopper further comprises a proximally disposed annular groove disposed to communicate through a wide proximal opening.

9. A multi-chamber syringe apparatus according to claim 1 wherein said valved stopper comprises material from which a syringe stopper is made.

10. A multi-chamber syringe apparatus according to claim 1 wherein said valved stopper comprises a distal frustoconical surface which substantially conforms to shape and size of a distal interior face of said syringe.

11. A multi-chamber syringe apparatus according to claim 8 wherein said valve assembly further comprises a separator which comprises a hollow-cylindrical body having a sealingly connecting structure, said structure comprising a shape and size relative to said stopper annular groove to permit said structure to be inserted into said annular groove to securely affix said separator to said stopper.

12. A multi-chamber syringe apparatus according to claim 11 wherein said structure and said each groove comprise a circular shape whereby said structure can be inserted into said groove in any radial orientation relative to said stopper.

13. A multi-chamber syringe apparatus according to claim 11 wherein said separator body comprises structure which is substantially closed at one end and has an open distal end, said open end being disposed about said slit when said connecting structure is disposed in contact with said annular groove.

14. A multi-chamber syringe apparatus according to claim 13 wherein said cylindrical body comprises a frustoconical shape.

15. A multi-chamber syringe apparatus according to claim 13 wherein said body comprises an outside surface and an inside surface and a plurality of holes displaced through the surfaces, said holes being sized and shaped to be permissive to liquid flow, but to impede gas flow to thereby act as a liquid filter which filters gas from liquid as liquid passes through the holes.

16. A multi-chamber syringe apparatus according to claim 11 wherein said cylindrical body comprises a plurality of internally directed elongated ribs which are radially displaced from said inside surface toward a hollow core of said body, said ribs comprising a clinching interface with said non-planar valve to, thereby, maintain said valve closed when force of the second differential pressure is imposed on the valve assembly.

17. A multi-chamber syringe apparatus according to claim 11 wherein said body comprises at least one hole disposed in a proximal side wherethrough gas is purged from the body.

18. A multi-chamber syringe apparatus according to claim 1 wherein the valve comprises a structure which requires a force which produces the third differential pressure to be tactilely discernable from the force which produces the first differential pressure.

19. A multi-chamber syringe apparatus according to claim 2 wherein said syringe comprises compressible matter within said proximal chamber such that, once said bi-stable valve is opened and, as a consequence of force applied to the stem to dispense liquid, energy is stored in said compressible matter which, once the force is removed from said stem, expanding decompression of said compressible matter inhibits reflux in an attached fluid line.

20. A multi-chamber syringe apparatus according to claim 11 wherein said apparatus further comprises a tubing set which effectively adds an additional chamber of liquid to said apparatus, said tubing set comprising:

an elongated length of tubing comprising a proximal and a distal end and an elongated orifice therethrough;

a proximal connection at said proximal end whereby said tubing set is securely affixed to said distal end of said syringe barrel;

a volume of liquid disposed within said elongated orifice;

a bubble of gas disposed between said proximal connector and said volume of liquid;

a connector assembly disposed at the distal end of the tubing;

said connector assembly comprising a second liquid filter for filtering gas of said gas bubble from liquid delivered through the tubing.

21. A multi-chamber syringe apparatus according to claim 11 wherein said separator comprises stabilizing wings which extend outward from said body to contact said interior surface to thereby stabilize said valve assembly within said barrel.

22. A multi-chamber syringe apparatus according to claim 1 wherein said barrel comprises a proximal section having a substantially constant inside diameter and a distal section also having a substantially constant inside diameter, however said proximal section having a larger diameter than said distal section and wherein a plunger is disposed within said proximal section and a valve assembly is disposed within said distal section.

45. A valve assembly according to claim 11 wherein said separator body comprises structure which is substantially closed at one end and has an open distal end, said open end being disposed about said slit when said connecting structure is disposed in contact with said annular groove and said substantially closed end comprising at least one hole.

49. A valve assembly according to claim 45 wherein said body comprises at least one hole disposed in a proximal side wherethrough gas is purged from the body.

23. A method for using a multi-chamber syringe apparatus comprising the steps of:

providing said apparatus comprising;

a syringe barrel having an internal surface which is concentrically disposed about an elongated medial axis, said barrel surface comprising an open proximal end and a distal end having a closed interior about an orifice through which fluid is transferred;

a stem and plunger combination disposed to be displaced within said barrel by application of a directional force against said stem for dislocating fluid thereby; and

a valve assembly disposed within said barrel between said plunger stopper and said distal end to provide a proximal chamber between the valve assembly and plunger stopper and a distal chamber between the valve assembly and said closed interior surface;

said valve assembly comprising;

a valved stopper comprising a normally closed, medially disposed valve in a distal face of the stopper and a hollow, grooved, cylindrical interior which opens proximally toward said plunger and which communicates with said plunger stopper via fluid, within the barrel, said valved stopper being distally displaced toward said distal end within said barrel when acted upon by a force directionally applied toward said distal end which produces a first differential pressure and being proximally displaced away from said distal end when acted upon by an oppositely directed force of a second differential pressure; and

said valved stopper further comprising structure which opens said valve to permit fluid flow there through when said stopper is acted upon by force of a third differential pressure which is in the same direction as force from the first pressure, the magnitude of the third differential pressure being greater than the first differential pressure.

24. A method for using a multi-chamber syringe apparatus according to claim 23 comprising an additional step of filling said proximal chamber with a first fluid.

25. A method for using a multi-chamber syringe apparatus according to claim 24 comprising additional steps of filling and emptying a second fluid, respectively to and from said distal chamber, by displacing said stem and plunger in a conventional manner, while retaining the first fluid disparate from the second fluid.

26. A method for using a multi-chamber syringe apparatus according to claim 24 comprising a step of filling the distal chamber with a second fluid.

27. A method for using a multi-chamber syringe apparatus according to claim 26 comprising a step of clearing air from the distal chamber by conventional purging techniques, while maintaining the second fluid disparate from the first fluid.

28. A method for using a multi-chamber syringe apparatus according to claim 24 comprising an additional step of displacing said valve assembly, by force of said first differential pressure, to abut said distal end of said internal surface, thereby dispensing only the second fluid from said distal chamber.

29. A method for using a multi-chamber syringe apparatus according to claim 28 comprising an additional step of applying the force upon the stem to produce a third differential pressure which changes the valve from a closed stable state to an open stable state.

30. A method for using a multi-chamber syringe apparatus according to claim 29 comprising dispensing the first fluid from the syringe apparatus.

31. A method for using a multi-chamber syringe apparatus according to claim 24 wherein said filling step comprises filling said proximal chamber with a fluid, the major portion of which is a liquid, the rest being gas.

32. A method for using a multi-chamber syringe apparatus according to claim 31 wherein said first fluid dispensing step comprises filtering the fluid being dispensed from the chamber such that gas flow is impeded.

33. A valve assembly which, when disposed within a barrel of a syringe divides a predetermined portion of the barrel into a first chamber proximal to the valve assembly and a second chamber distal to the valve assembly, said valve assembly comprising:

a valved stopper comprising a normally closed, medially disposed valve in a distal face of the stopper and a hollow, grooved, cylindrical interior which opens proximally within said barrel and which communicates with pressure of fluid within the first and second chambers to be distally displaced within said barrel when acted upon by a first differential pressure and to be proximally displaced when acted upon by an oppositely directed differential force of a second differential pressure; and

said valved stopper further comprising structure which only opens said valve to permit fluid flow there through when said stopper is acted upon by force of a third differential pressure which is in the same direction as force of the first differential pressure, the magnitude of the third differential pressure being greater than the first differential pressure.

34. A valve assembly according to claim 33 wherein said valved stopper comprises a bi-stable valve.

35. A valve assembly according to claim 34 comprises a slit valve comprising a medially disposed slit valve.

36. A valve assembly according to claim 35 wherein said bi-stable valve comprises a non-planar structure.

37. A valve assembly according to claim 36 wherein said non-planar valve comprises structure which defines operation of said valve to be bi-stable such that, once opened, said valve remains open.

38. A valve assembly according to claim 37 wherein said valved stopper further comprises a hinge disposed about said valve structure which articulates about said valve structure to permit the valve to be displaced to an open state when acted upon by force of said third differential pressure and to retain the valve in the open state, once opened.

39. A valve assembly according to claim 36 wherein said non-planar valve structure comprises a hemispherical dome shape.

40. A valve assembly according to claim 33 wherein said valved stopper further comprises a proximally disposed annular groove disposed to communicate through a wide proximal opening.

41. A valve assembly according to claim 33 wherein said valved stopper comprises material from which a syringe stopper is made.

42. A valve assembly according to claim 33 wherein said valved stopper comprises a distal frustoconical surface which substantially conforms to shape and size of a distal interior face of a syringe barrel.

43. A valve assembly according to claim 40 wherein said valve assembly further comprises a separator which comprises a hollow-cylindrical body having a sealingly connecting structure, said structure comprising a shape and size relative to said stopper annular groove to permit said structure to be inserted into said annular groove to securely affix said separator to said stopper.

44. A valve assembly according to claim 43 wherein said structure and said each groove comprise a circular shape whereby said structure can be inserted into said groove in any radial orientation relative to said stopper.

46. A valve assembly according to claim 43 wherein said hollow-cylindrical body comprises a frustoconical shape.

47. A valve assembly according to claim 43 wherein said hollow-cylindrical body comprises an outside surface and an inside surface and a plurality of holes displaced through the surfaces, said holes being sized and shaped to be permissive to liquid flow, but to impede gas flow to thereby act as a liquid filter which filters gas from liquid as liquid passes through the holes.

48. A valve assembly according to claim 43 wherein said hollow-cylindrical body comprises a plurality of internally directed elongated ribs which are radially displaced from said inside surface toward a hollow core of said body, said ribs comprising a clinching interface with said non-planar valve to, thereby, maintain said valve closed when force of the second differential pressure is imposed on the valve assembly.

50. A valve assembly according to claim 33 wherein the valved stopper comprises a structure which requires a force producing the third differential pressure to be tactilely discernable from a force producing the first differential pressure.

51. A valve assembly according to claim 43 wherein said separator comprises stabilizing wings which extend outward from said body to contact an interior surface of a syringe barrel in which said valve assembly is disposed to thereby stabilize said valve assembly within the barrel.

52. A tubing set for adding a chamber of liquid to a dispensing vessel containing a fluid to be dispensed therefrom, said tubing set comprising:

an elongated length of tubing comprising a proximal and a distal end and an elongated orifice therethrough;

a proximal connection at said proximal end whereby said tubing set is securely affixed to the dispensing vessel;

a volume of liquid disposed within said elongated orifice;

a bubble of gas separating said proximal end from said volume of liquid to thereby make the fluid in the dispensing vessel disparate from said volume of liquid;

a connector assembly disposed at the distal end of the tubing;

said connector assembly comprising a liquid filter gas separator whereby gas of said gas bubble is filtered from liquid delivered through the tubing.