Multi-chamber, sequential dose dispensing syringe

• US 6,997,910 B2
• Filed: 05/03/2004
• Issued: 02/14/2006
• 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., Mercer, James Victor, Howlett, Michael Wallace
• Primary Examiner(s): Kennedy, Sharon
• Application Number:
  US10/838,101
• Publication Number:
  US 20050245880A1
• Time in Patent Office: 652 Days
• Field of Search: 604/191, 604/218, 604 89- 91, 604/184, 604/213, 604/226, 604/231, 604/237, 604/238
• 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 effectively partitions a syringe into proximal and distal chambers to provide a multi-chamber, sequentially dispensing syringe apparatus. The valve assembly may be effectively used with a variety of standard, currently available commercial syringes and pre-filled syringes. Incorporated in the valve assembly is a valved stopper having a valve (which may be a slit valve), an impact sensor which opens the valve upon impact between the valve assembly and internal distal end of the syringe and a gas separator which separates liquid from gas disposed in the proximal chamber to assure gas is not delivered therefrom. The valve assembly is displaced as a plunger of the syringe is displaced via communication through fluid in the proximal chamber of the syringe. The actuator has a latching feature which latches the valve to an open state after being opened by the impact sensor. The gas separator has a proximally disposed orifice which facilitates priming. The valve assembly may be made from two parts. One part, a valved stopper, may be molded from the same rubber based material used in syringe plunger stoppers. The second part, the valve actuator, may be injection molded as a single part. A synthetic resinous material which is compatible with manufacture of living hinges my be used for the second part. Multiple valve assemblies may be used in a single syringe barrel.

Claims

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

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

a plunger and plunger stopper combination disposed to be displaced within said barrel 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 interior surface;

said valve assembly comprising;

a valved stopper comprising a distal face and a hollow, grooved, cylindrical interior which opens proximally toward said plunger stopper and which communicates with said plunger stopper via fluid within the barrel, therebetween, to be displaced as the plunger stopper is displaced;

said valved stopper further comprising an operable, normally closed valve, which permits displacement of fluid therethrough only when open, and a pliable material whereby said distal face cooperatively conforms to the shape of the interior surface when forced thereupon; and

a valve actuator comprising features which are complimentary to grooves of the interior of the valved stopper whereby the actuator is securely affixed to the valved stopper and is displaced as the valved stopper is displaced;

said actuator further comprising structure for sensing impact between said distal face and said interior surface and, upon sensing the impact, reactively causes said valve to open.

2. Apparatus according to claim 1 wherein said actuator comprises a medially disposed elongated body which comprises a hollow opening which communicates with said valve.

3. Apparatus according to claim 2 wherein said actuator comprises at least one stabilizing element, affixed to said body which acts upon the valved stopper to resist canting of the valved stopper within the barrel to thereby assure stability of the valved stopper during forcible displacement by the plunger and plunger stopper combination.

4. Apparatus according to claim 3 wherein said at least one stabilizing element comprises a circular disk sized and shaped to provide support within the hollow of the valved stopper.

5. Apparatus according to claim 2 wherein said valve comprises a slit disposed through the distal face of said valved stopper.

6. Apparatus according to claim 5 wherein said stopper comprises a size and shape relative to said hollow syringe barrel which maintains said slit in a normally closed state unless acted upon by a valve opening mechanism of said impact sensing structure.

7. Apparatus according to claim 5 wherein said impact sensing structure comprises an arm which comprises a hinged connection to said body, said arm having a distally extending appendage which communicates with said inner surface through said distal face upon impact between the distal face and inner surface articulates to open said slit.

8. Apparatus according to claim 7 wherein said arm further comprises an outwardly extending part which is in contact with the hollow cylindrical interior of said stopper and which articulates as said arm articulates.

9. Apparatus according to claim 8 wherein said arm and said part couple comprise sufficient length away from said hinged connection to compressively act to forcibly maintain said slit closed prior to impact between said closed face and the inner surface.

10. Apparatus according to claim 8 wherein said part comprises sufficient length to be securely but releasibly affixed by the cylindrical interior of the stopper when angularly distally disposed toward said distal face to provide a latch for maintaining said valve closed prior to articulation of said arm and part.

11. Apparatus according to claim 8 wherein said part comprises a length which permits forcible articulation of said part from being angularly distally disposed to be angularly proximally disposed as said arm and part are articulated upon impact.

12. Apparatus according to claim 8 wherein said part comprises sufficient length to be retained by the cylindrical interior of the stopper in a proximally angularly disposed state relative to said distal face to thereby provide a latch for maintaining said valve open following articulation of said arm and part.

13. Apparatus according to claim 2 wherein said valve actuator body further comprises a gas separator interposed between said proximal chamber and said valve.

14. Apparatus according to claim 13 wherein said gas separator comprises a hollow body having a distal mouth having an orifice which opens about said valve and which otherwise impedes fluid flow through said valve.

15. Apparatus according to claim 14 wherein said valve actuator body comprises an elongated shape, thereby providing a support for said at least one stabilizing element and the impact sensing structure.

16. Apparatus according to claim 14 wherein said body of said gas separator comprises a plurality of holes of predetermined size which pass liquid in preference to gas when said body is primed with liquid.

17. Apparatus according to claim 14 wherein said valve actuator body comprises a frustoconical shape.

18. Apparatus according to claim 14 wherein said valve actuator body comprises a proximal hole medially disposed therein, said proximal hole having sufficient diameter to permit air to be purged therethrough for the purpose of priming said body with liquid.

19. A combination for providing a sequentially dispensing, multi-chamber syringe, said combination comprising:

a hollow syringe barrel having a distal end which is closed except for a fluid transfer orifice;

a syringe plunger;

a valve assembly distally disposed in the syringe barrel relative to the syringe plunger, the valve actuator separating space within the barrel into proximal and distal chambers;

said valve assembly comprising;

a valved stopper comprising a stopper body comprising a normally closed valve element; and

a valve actuator rigidly affixed to said valved stopper, said valve actuator comprising at least one stabilizing element for stabilizing said valved stopper within the barrel, a sensor arm which senses impact between the valved stopper and the closed distal end of the syringe barrel and which articulates upon such impact to open the valve element, a gas separator which separates gas from liquid flowing from the proximal chamber thereby permitting only liquid to be dispensed thereby.

20. A method for assembling a valve actuator for use in dividing a syringe into proximal and distal chambers, to thereby provide a sequential delivery multi-chamber syringe apparatus, comprising the steps of:

providing a valve actuator having at least one distally disposed connecting lip;

providing a stopper having a hollow cylindrical body having an annular side for compressibly interfacing with an interior surface of a hollow syringe barrel and a closed, substantially circular surface at one end of the side, said stopper further comprising at least one grooved slot whereby said at least one lip, and, therefore, said valve actuator are securely affixed to said stopper;

providing an assembly fixture having an open annular well with an internal ledge sized and shaped to receive and support the stopper when disposed thereat, said fixture further comprising a blade having a sharpened tip medially and transversely disposed relative to said ledge, said sharpened tip being directed outward from the open well;

displacing the stopper into said fixture such that the closed surface opposes the sharpened tip; and

displacing the valve actuator into the hollow body of the stopper, thereby forcing the at least one lip to be securely affixed to the at least one grooved slot thereby engaging and securing the actuator to the stopper and simultaneously forcing the sharpened tip through the closed circular surface to form a slit for a slit valve thereby.

21. A method for using a valve assembly as a chamber divider in a multi-chamber, sequentially dispensing syringe comprising the steps of:

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

providing a plunger and plunger stopper combination, associated with the syringe, disposed to be displaced within said barrel for dislocating fluid thereby; and

providing 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 interior surface;

said valve assembly comprising;

a valved stopper comprising a distal face and a hollow, grooved, cylindrical interior which opens proximally toward said plunger stopper and which communicates with said plunger stopper via fluid within the barrel, therebetween, to be displaced as the plunger stopper is displaced;

said valved stopper further comprising an operable, normally closed valve, which permits displacement of fluid therethrough only when open, and a pliable material whereby said distal face cooperatively conforms to the shape of the interior surface when forced thereupon; and

a valve actuator comprising features which are complimentary to grooves of the interior of the valved stopper whereby the actuator is securely affixed to the valved stopper and is displaced as the valved stopper is displaced;

said actuator further comprising structure for sensing impact between said distal face and said interior surface and, upon sensing the impact, reactively causes said valve to open;

installing said valve assembly at a predetermined site in the barrel of the syringe;

filling the proximal chamber with a predetermined first liquid;

inserting the plunger and plunger stopper combination to seal and retain the first liquid in the proximal chamber;

filling the distal chamber with a second liquid; and

distally displacing the plunger and plunger stopper to sequential dispense first the second liquid from the distal chamber and then, afterward, to dispense the first liquid from the proximal chamber.

22. The method according to claim 21 wherein the dispensing step comprises distorting the valved stopper at the end of second liquid dispensing step to reduce dead space wherein a volume of the second liquid would be retained in the syringe.

23. The method according to claim 21 wherein impact of the valved stopper with the closed interior surface results in opening the valve.

24. The method according to claim 21 wherein the first liquid dispensing step further comprises separating gas from the second liquid and trapping that gas within a portion of the proximal chamber where the gas is retained and not dispensed with the first liquid.

25. The method according to claim 21 wherein the valve assembly installing and proximal chamber filling steps are repeated to form an intermediate chamber which results in providing a three chamber multi-chamber sequential delivery syringe.

26. The method according to claim 21 wherein the valve assembly installing and proximal chamber filling steps are performed more than once to form at least one intermediate chamber which is further used for delivering a sequential series of doses from the syringe.

27. A gas separator apparatus for a patient liquid delivery line, said separator apparatus comprising:

a smaller vessel having an effluent opening toward the delivery line;

a larger vessel which contains the smaller vessel, said larger vessel containing fluid which comprises a deliverable liquid outside the smaller vessel;

said smaller vessel being primed with the deliverable liquid and further comprising a series of holes which are sized to pass liquid at a lower resistance than passing gas into through the holes into the primed chamber;

said larger vessel comprising a space outside the smaller vessel wherein the gas is trapped.