CA2565531A1 - Multi-chamber, sequential dose dispensing syringe - Google Patents

Multi-chamber, sequential dose dispensing syringe Download PDF

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Publication number
CA2565531A1
CA2565531A1 CA002565531A CA2565531A CA2565531A1 CA 2565531 A1 CA2565531 A1 CA 2565531A1 CA 002565531 A CA002565531 A CA 002565531A CA 2565531 A CA2565531 A CA 2565531A CA 2565531 A1 CA2565531 A1 CA 2565531A1
Authority
CA
Canada
Prior art keywords
stopper
valve
syringe
liquid
chamber
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002565531A
Other languages
French (fr)
Other versions
CA2565531C (en
Inventor
Michael Howlett
James Mercer
Gale Thorne, Jr.
Gale H. Thorne
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
INFUSIVE TECHNOLOGIES LLC
Original Assignee
Infusive Technologies, Llc
Michael Howlett
James Mercer
Gale Thorne, Jr.
Gale H. Thorne
Thorne Medical, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Infusive Technologies, Llc, Michael Howlett, James Mercer, Gale Thorne, Jr., Gale H. Thorne, Thorne Medical, Inc. filed Critical Infusive Technologies, Llc
Publication of CA2565531A1 publication Critical patent/CA2565531A1/en
Application granted granted Critical
Publication of CA2565531C publication Critical patent/CA2565531C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/284—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle comprising means for injection of two or more media, e.g. by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M2005/1787—Syringes for sequential delivery of fluids, e.g. first medicament and then flushing liquid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3128—Incorporating one-way valves, e.g. pressure-relief or non-return valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
    • A61M5/286—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31596—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms comprising means for injection of two or more media, e.g. by mixing

Abstract

A valve assembly is disclosed which partitions a syringe into proximal and distal chambers to provide a multi-chamber, sequentially dispensing syringe apparatus. The valve assembly has a valved stopper, 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 from gas disposed in the proximal chamber to assure gas is not delivered therefrom. The valve assembly is in fluid communicating with an associated syringe plunger and is displaced thereby. The valve assembly may be made from two parts. One part, a valved stopper, may be molded from rubber based material used in syringe plunger stoppers. The second part, the valve actuator, may be injection molded.

Claims (25)

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

a hollow syringe barrel having a distal end which is closed to form an interior surface which is entirely 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 assembly separating space within the barrel between the syringe plunger and fluid transfer orifice into a proximal chamber and a distal chamber;
said valve assembly being characterized by:

a valved stopper comprising a stopper body comprising a normally closed valve element which is opened to provide a flow path from the proximal chamber toward the fluid transfer orifice when the valve is open;
and a body part comprising an interlocking interface for securely affixing the part to said valved stopper, said part being characterized by a gas separator which provides at least one liquid pathway for communicating liquid resident in the proximal chamber toward the normally closed valve but inhibits gas resident in the proximal chamber from flowing through the at least one liquid pathway, thereby permitting only liquid to be dispensed through the normally closed valve toward the fluid transfer orifice when the valve is open.
2. The combination according to Claim 1 wherein said valve assembly is further characterized by:

the valved stopper further comprising a distal face and a hollow, grooved, cylindrical interior which opens proximally toward said syringe plunger and which communicates with said syringe plunger via fluid within the proximal chamber, to be displaced as the syringe plunger is displaced, and a pliable material whereby said distal face cooperatively conforms to the shape of the interior surface when forced thereupon;

the body part being characterized by a valve actuator comprising features which are complimentary to grooves of the interior of the valved stopper whereby the body part 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 urges said valve element to open.
3. The combination according to Claim 2 wherein said valve actuator comprises a medially disposed elongated body which forms the gas separator and which comprises a hollow opening which communicates with said valve element.
4. The combination according to Claim 3 wherein said actuator comprises at least one stabilizing element, affixed to said elongated 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 syringe plunger.
5. The combination according to Claim 4 wherein said at least one stabilizing element comprises a strut sized and shaped to provide support within the hollow of the valved stopper.
6. The combination according to Claim 2 wherein said valve element comprises a slit disposed through the distal face of said valved stopper to form the normally closed valve element.
7. The combination according to Claim 6 wherein said valved stopper is characterized by 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.
8. The combination according to Claim 7 wherein said impact sensing structure is characterized by 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 and, as a result of impact, articulates to open said slit.
9. The combination according to Claim 8 wherein said arm further is characterized by an outwardly extending part which is in contact with the hollow cylindrical interior of said stopper and which articulates as said arm articulates.
10. The combination according to Claim 9 wherein said arm and said outwardly extending part in combination comprise sufficient length away from said hinged connection to compressively act to forcibly maintain said slit closed prior to impact between said distal face and the distal interior surface.
11. The combination according to Claim 10 wherein said outwardly extending 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 outwardly extending part.
12. The combination according to Claim 9 wherein said part comprises a length which results in forcible articulation of said part from being angularly distally disposed to be angularly proximally disposed as said arm and part are articulated upon impact between the stopper and distal interior surface.
13. The combination according to Claim 9 wherein said outwardly extending 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 urging said valve to remain in an open state following articulation of said arm and outwardly extending part.
14. The combination according to Claim 1 wherein said gas separator comprises a hollow body having a distal mouth having an orifice which opens about said valve to provide a fluid pathway therethrough and which otherwise impedes fluid flow through said valve.
15. The combination according to Claim 1 wherein said gas separator is characterized by a plurality of holes of predetermined size which pass liquid in preference to gas when said body is primed with liquid.
16. The combination according to Claim 2 wherein said valve actuator body comprises a hollow frustoconically shaped core which comprises the gas separator.
17. Apparatus according to Claim 2 wherein said body part is characterized by a proximal hole medially disposed therein, said proximal hole having sufficient diameter to permit gas to be purged therethrough for the purpose of priming said body with liquid.
18. 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, being characterized by 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;

orienting the valve actuator to a predetermined angle relative to 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.
19. 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 being characterized by:

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.
20. The method according to Claim 19 wherein the dispensing step is characterized by 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.
21. The method according to Claim 19 wherein the distally displacing step is characterized by opening the valve upon impact of the valved stopper with the closed interior surface.
22. The method according to Claim 19 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.
23. The method according to Claim 19 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.
24. The method according to Claim 19 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.
25. A method for filtering gas from liquid being delivered to a delivery line, said method being characterized by the steps of:

providing a smaller vessel having an external surface characterized by a series of holes which are sized to pass liquid at a lower resistance than passing gas through that external surface toward an effluent opening on a path to the delivery line to thereby inhibit passage of gas into the smaller vessel as long as at least one hole is in communication with liquid;

providing a larger vessel having an internal volume into which the smaller vessel is displaced with said internal volume being in communication with said external surface, said larger vessel further containing fluid which communicates with said external surface and holes of the smaller vessel, said fluid comprising a combination of a desired deliverable liquid and a gas disposed outside the smaller vessel;

priming said smaller vessel with liquid; and acting to displace fluid from the larger vessel into the smaller vessel whereby only the desired liquid from said larger vessel is displaced into the smaller vessel and therethrough to the delivery line.
CA2565531A 2004-05-03 2005-04-26 Multi-chamber, sequential dose dispensing syringe Expired - Fee Related CA2565531C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/838,101 US6997910B2 (en) 2004-05-03 2004-05-03 Multi-chamber, sequential dose dispensing syringe
US10/838,101 2004-05-03
PCT/US2005/014299 WO2005110516A2 (en) 2004-05-03 2005-04-26 Multi-chamber sequential dose dispensing syringe

Publications (2)

Publication Number Publication Date
CA2565531A1 true CA2565531A1 (en) 2005-11-24
CA2565531C CA2565531C (en) 2011-10-11

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ID=35188043

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2565531A Expired - Fee Related CA2565531C (en) 2004-05-03 2005-04-26 Multi-chamber, sequential dose dispensing syringe

Country Status (10)

Country Link
US (3) US6997910B2 (en)
EP (1) EP1742686A4 (en)
JP (1) JP2007535987A (en)
CN (2) CN101559247A (en)
AU (1) AU2005243678B2 (en)
BR (1) BRPI0510532A (en)
CA (1) CA2565531C (en)
HK (1) HK1105177A1 (en)
MX (1) MXPA06012625A (en)
WO (1) WO2005110516A2 (en)

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US7048720B1 (en) 2006-05-23
US20050245880A1 (en) 2005-11-03
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CN1980706B (en) 2010-06-16
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BRPI0510532A (en) 2007-10-30
US20060100590A1 (en) 2006-05-11

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