WO2008091251A2 - Mixing syringe with and without flush - Google Patents
Mixing syringe with and without flush Download PDFInfo
- Publication number
- WO2008091251A2 WO2008091251A2 PCT/US2007/001848 US2007001848W WO2008091251A2 WO 2008091251 A2 WO2008091251 A2 WO 2008091251A2 US 2007001848 W US2007001848 W US 2007001848W WO 2008091251 A2 WO2008091251 A2 WO 2008091251A2
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- WIPO (PCT)
- Prior art keywords
- chamber
- mixing
- fluid
- syringe
- barrel
- Prior art date
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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
- A61M5/31—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
-
- 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
- A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
- A61M2005/3104—Caps for syringes without needle
-
- 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
- A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
- A61M2005/31516—Piston or piston-rod constructions, e.g. connection of piston with piston-rod reducing dead-space in the syringe barrel after delivery
-
- 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
Definitions
- This invention relates to mixing syringes and multi- chamber syringes and, in particular, to mixing syringes which utilize conventional syringe barrels and, in the case of multi-chamber flush syringes, dispense fluid from each chamber sequentially.
- This invention is a Continuation-in-Part of Thorne, Jr. which discloses multi-chamber syringes which can be used for sequential delivery of fluids.
- this instant invention can involve a combination of both a mixing syringe and a sequential fluid delivery application, contents of Thorne, Jr. are included herein by reference.
- Syringes for storing and mixing materials comprising diluents in one chamber and either dry (e.g. lyophilized) or liquid reagents (e.g. medications) in a disparate chamber are well known.
- Such syringes provide a means for mixing, while both materials are kept disparate within the syringe prior to use.
- Achieving a mixing syringe in current art has taken many forms, including frangible diaphragms, special barrel geometries which permit fluid flow between chambers when a separating stopper is displaced to a predetermined slotted or expanded portion of a barrel, telescoping barrels and plugs. Often some type of special barrel design is utilized. Beyond the requirement for special barrel design, there may be performance issues associated with such syringes, such as dead space and numbers of mixing syringe parts and complexity. As an example, U.S. Patent 4,041,945 titled MIXING SYRINGE and issued to Aeneus C.
- Guiney August 16, 1977 discloses mixing syringe apparatus which employs a conventional syringe barrel.
- One chamber for a diluent is disposed in the syringe barrel.
- a chamber for material to be diluted is disposed in a chamber formed in a resilient piston head. It is noted that such a mixing syringe limits volume of material which can be diluted and establishes a dead space relative to a delivered volume.
- each serial delivery syringe chambers are separated by an intermediate sliding stopper or other part which receives motive force communicated through an intermediate fluid from a primary stopper which is part of a plunger assembly and against which an external force is applied.
- each intermediate stopper must provide a fluid-tight seal to assure that no inadvertent chamber-to-chamber communication occurs and that all fluid from a distal chamber is evacuated from the syringe before dispensing fluid from a more proximal chamber. Once the distal chamber of the syringe is so purged, that intermediate stopper must be breached or bypassed to permit dispensing of the contents of a proximal or intermediate chamber .
- assembly ni a device which is made from at least two interconnected parts
- barrel n a cylindrical elongated portion of a syringe which is conventionally open on one end to receive a plunger and stem used for displacing fluid within the barrel and partially closed at an opposite end except for an orifice through which fluid is ejected or aspirated bi-stable adj : a descriptor for a device having two stable states clinch n: a structure or device which acts upon a part to clamp it closed while in contact therewith conventional adj i sanctioned by general custom; i.e.
- ⁇ P liquid volume differential pressure
- ⁇ an arcuately shaped surface
- a hemisphere downstream adj a direction which is consistent with flow out of a syringe or away from a user fluid
- ⁇ a substance (e.g. a liquid and/or gas) which tends to take the shape of a container front adj/n: distally disposed or a distally disposed site (e.g. a front of a syringe comprises the dispensing orifice) gas
- n a fluid which is neither solid nor liquid liquid
- n a fluid which is neither solid nor gaseous, generally considered to be free flowing like water non-planar adj : not planar in a resting or stable state medial adj: occurring away from an outer edge; disposed near the center of (e.g. disposed away from an edge or periphery and in the vicinity of a center of gravity or axis of symmetry)
- P d n pressure in a distal chamber or a pressure which is distally disposed relative to a structure across which a differential pressure is effected plunger ni a portion of a syringe piston apparatus usually affixed to a syringe stem which is used to displace fluid within a syringe barrel prime v: to fill liquid into a cavity generally by removing air therefrom (e.g. priming a gas separator)
- ⁇ a type of undesired retrograde (upstream) flow of liquid (e.g.
- separator n a liquid filter which impedes passage of air while permitting liquid to flow through the separator state n: mode or condition of being; when referenced to a valve assembly, a condition which permits or restricts fluid flow under predetermined conditions stict ⁇ on n: a special case of friction; stiction being the force required to initiate motion to a resting body, esp. when stiction is greater than moving friction stem jr.: an elongated part which fits within a syringe barrel and is affixed to a plunger for the purpose of displacing fluid within the barrel stop n: a obstruction which is differentiated from friction or stiction, esp.
- each stopper contains a self-actuating valve syringe n: a device used for injecting or withdrawing fluids upstream adj : a direction which is against the direction of flow from a syringe (opposite of downstream)
- the currently preferred embodiment of this novel invention alleviates all known problems related to providing an effective mixing syringe assembly and/ further, a mixing syringe assembly and multi-chamber, sequential dose dispensing syringe combination.
- the invention employs a syringe of traditional design which has a conventional hollow barrel having an elongated internal cylindrical surface, the 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, the combination being disposed to be displaced within said barrel, for mixing, by application of force, in a predetermined direction, against the stem, thereby imposing differential pressures which displace fluid within the barrel.
- a removable cap is disposed about the orifice and, in combination with the plunger, fully confines all fluid and material previously stored within said syringe barrel between the plunger and cap.
- a displaceable valved stopper is disposed within the barrel between the plunger and the distal end to provide a more proximal chamber disposed between the plunger and the valved stopper, thereby providing a container for a first volume of matter, and a more distal chamber, disposed between the distal end and the valved stopper as a container for a second volume of matter.
- the first and second volumes of matter are thereby kept disparate before mixing.
- Mixing is accomplished by action of forcing displacement of the stem in the predetermined direction.
- the displaceable valved stopper comprises a normally- closed valve which yields to an open state when the predetermined pressure differential is disposed across the valved stopper. Orientation of the valve determines direction of application of force upon the stem to open the valve. That pressure differential which opens the valve causes fluid flow to be dispensed through the valve, thereby mixing fluid from one chamber (the dispensing chamber) with fluid resident in the other (receiving) chamber.
- Such a biasing memory element may be provided in place of the stem within the barrel of the syringe prior to mixing.
- the biasing element maintains a differential pressure across the valved stopper which keeps the valve closed during shipping, storage and before use.
- a valve assembly like the valve assembly disclosed in Thorne, Jr. is disposed between the valved stopper and plunger to divide the more proximal chamber into a middle chamber and a most proximal chamber.
- the middle chamber acts as the more proximal chamber the previous embodiment described.
- the most proximal chamber is filled with a fluid which may be used as a flush. All three chambers retain matter disparate until used.
- Fluid from the most proximal chamber is dispensed separately and sequentially following mixing and dispensing of mixed fluid from the distal and middle chambers.
- the cap is removed prior to dispensing fluids from the syringe. Dispensing is accomplished by conventional application of force upon the stem.
- the invention involves at least one (first) distally disposed displaceable valved stopper which is designed to operate within a conventional syringe to separate a most distal chamber from a more proximal chamber.
- the distal chamber before dispensing, generally contains a first fluid volume, which may be a diluent; however, in a second basic embodiment, the distal chamber may contain a mass or other material to be diluted.
- the adjacent, more proximal chamber contains a disparate second fluid volume or mass of material.
- an initial state of a closed valve in the first stopper keeps the contents of each chamber separate from the other until initiation of a mixing step.
- a cap which seals the syringe against influent or effluent fluid flow is disposed to block fluid flow in or out of the syringe until the mixing step is complete.
- a plunger affixed to a stem of the syringe is used as a forcing tool both in mixing and in dispensing fluids from the syringe. Generally, the plunger communicates force, applied against the syringe stem, to the valved stopper through an intermediate fluid.
- the distal face of the valved stopper is shaped to correspond to the internal shape of the distal end of the syringe to minimize dead space. All parts which communicate with the proximal side of the valved stopper are also shaped to nest or otherwise correspond to the proximal side of the valved stopper to similarly minimize dead space.
- the valve in the first valved stopper has several important and critical features. First, the valve remains absolutely closed in a first state when a first positive ⁇ P (a zero ⁇ P being considered positive) is disposed across the valve, thus keeping fluid or other matter in the chambers disparate during shipping, storage and prior to mixing.
- the valve in the first valved stopper is designed to become patent to flow of fluid, in the first state, from the distal chamber into the proximal chamber when a negative ⁇ P is imposed across the valved stopper by proximal displacement of the stem and plunger within the barrel of the syringe.
- a negative ⁇ P When imposing such a negative ⁇ P upon the valved stopper, it is critical that a portion of the fluid in the distal chamber be gas (e.g. air) to provide an elastically expandable and compressible component therein.
- proximally directed force and resulting proximal displacement of the stem ultimately "pumps" substantially all fluid from the distal chamber and, thereby, displaces the valved stopper to abut the internal distal face of the syringe with substantially all of the fluid originally disposed in the distal chamber being displaced to mix with fluid in the more proximal (mixing) chamber.
- the mixed fluids may be directly dispensed or further mixed by an alternate step.
- a distally directed force is imposed upon the stem to create a predetermined positive switching pressure gradient across the valved stopper while the valved stopper is abutting the internal distal face of the syringe.
- Such a pressure gradient causes the valved stopper to be switched to a second state which is permissive to distally directed fluid flow through the valve.
- the valve in the second state must then restrict proximal fluid flow when force is relieved from the stem. In such a case, each time distally directed force is applied to the stem, after the valve is switched to the second state, fluid is pumped from the proximal chamber through the valve into the distal chamber to abet additional mixing.
- a distally directed force is applied to the stem, then, by conventional procedures, gas (i.e. usually air) is primed from the syringe followed by dispensing of mixed liquid.
- gas i.e. usually air
- two valved stoppers are employed. The more distal stopper is the same as the first valved stopper disclosed supra.
- the second or more proximal valved stopper is part of a stopper assembly, an example of which is disclosed in Thorne, Jr., incorporated herein by reference.
- the two stoppers divide the barrel of the syringe into three chambers .
- the most distal two chambers perform the same storage and mixing functions disclosed for the mixing syringe assembly disclosed supra.
- the third and most proximal chamber is generally used for storing a third disparate fluid, such as, for example, a flush solution.
- the stopper assembly comprises two elements, the second valved stopper and a stopper stabilizer and gas separator (referenced hereafter as a
- the valved stopper contains a valve mechanism held closed by a clinch and is only actuated by a predetermined positive pressure differential across the valve.
- the stopper assembly may be displaced proximally by action against the stem and associated plunger to "pump" fluid from the distal chamber into the next more proximal chamber (which is the mixing chamber) as disclosed supra.
- the valve of the valve assembly only opens when displaced to collide with a more distal end of the syringe (or another stop within the syringe such as against the first valved stopper) , solutions contained in the mixing chamber and in the most proximal chamber are kept disparate during mixing and dispensing of the mixed solution. Only after the mixed solution is fully dispensed (when the valve assembly collides and nests against the first valved stopper) does the valve of the second valved stopper open. Thus, the following steps are achieved:
- the syringe stem and plunger are drawn proximally and released until contents of the most distal chamber are displaced for mixing into the middle chamber.
- the chamber holding the mixed fluid is purged of air.
- the syringe is connected to a dispensing site. 6.
- the syringe stem and plunger are displaced distally to dispense liquid from the mixing chamber.
- valve, of the valve assembly is opened by an increased positive ⁇ P (force against the stem and plunger) and content of the most proximal chamber is dispensed. Note that, one basic difference between the valved stopper disclosed in Thome, Jr.
- the second valved stopper is that, rather than contouring the distal face of the second valved stopper to correspond to the inner distal face of the syringe barrel (as taught in Thorne, Jr.), the distal face of the second valved stopper is contoured to nest within the proximal side of the first valved stopper to minimize dead space as the mixed solution is dispensed from the syringe prior to actuation of the valve in the second valved stopper for the purpose of dispensing fluid from the most proximal chamber.
- a second embodiment of the instant invention involves a valved stopper having a normally-closed valve which is permissive to distal flow when a positive differential force is applied across the valved stopper.
- diluent is stored in a more proximal chamber and medical matter to be diluted is disposed in the distal chamber. Successive imposition of force producing a positive pressure differential across the valved stopper displaces fluid from the more proximal chamber to the distal chamber where mixing occurs.
- Figure 1 is a perspective of a two chamber mixing syringe assembly made according to the instant invention, a syringe of the syringe assembly comprising a barrel having a traditional elongated substantially cylindrical shape.
- Figure IA is a perspective of the two chamber mixing syringe assembly seen in Figure 1 with a syringe stem removed and replaced by a spring assembly which biases pressure against more distal parts to provide stability for the valve in the valved stopper in shipping, handling and storage prior to use.
- Figure 2 is a perspective of the two chamber mixing syringe assembly seen in Figure 1 with a valved stopper disposed in a first state and displaced as fluid is drawn from a more distal chamber into a more proximal chamber for mixing.
- Figure 3 is an exploded view of the two chamber mixing syringe assembly seen in Figures 1 and 2.
- Figure 4 is a distal perspective of a valved stopper which separates the more distal chamber from the more proximal chamber in Figures 1 and 2.
- Figure 4A is a cross section of the valved stopper seen in Figure 4 taken along lines 4A-4A.
- Figure 5 is a proximal perspective of the valved stopper seen in Figure 4.
- Figure 6 is a distal perspective of the valved stopper seen in Figure 4, with a slit valve disposed in a second or open state .
- Figure 6A is a distal perspective of a valve stopper similar to the valved stopper seen in Figure 6, but with an open state which forms a one-way valve about a slit.
- Figure 7 is a distal perspective of a plunger which is associated with a stem of the syringe seen in Figures 1 and 2.
- Figure 8 is a perspective of the syringe assembly of Figures 1 and 2 with the valved stopper displaced to abut the most distal inner front surface of the syringe barrel.
- Figure 8A is a perspective of a syringe assembly similar to the syringe assembly seen in Figure 8 with a valve of a valved stopper switched to an open state, the valved stopper displaced proximally relative to the valved stopper seen in Figure 8.
- Figure 9 is a perspective of the syringe assembly of Figure 8 with a cap removed and the valve of the valved stopper disposed in an open state such that fluid may be dispensed from the syringe barrel.
- Figure 10 is a perspective of the syringe assembly of Figures 7 and 9 with fluid completely dispensed and the plunger nested into the valved stopper to minimize dead space.
- Figure 11 is a perspective of a three chamber mixing and flush syringe assembly according to the invention which is similar to the syringe assembly seen in Figure 1, but having a valve assembly which separates the more proximal chamber of the syringe of Figure 1 into a middle chamber and a most proximal chamber.
- Figure 12 is a perspective of the three chamber mixing and flush syringe assembly seen in Figure 11, but with the valve assembly displaced away from the valved stopper to provide a larger middle chamber than is seen in the middle chamber of Figure 11.
- Figure 13 is an exploded view of the three chamber mixing and flush syringe assembly seen in Figures 11 and 12.
- Figure 14 is an in-line perspective of the valved stopper, valve assembly and plunger seen in Figures 11 and 12.
- Figure 15 is a perspective the valve assembly seen in Figure 14.
- Figure 16 is a perspective of the valved stopper and the valve assembly, each with a slit valve disposed to an open state.
- Figure 17 is a perspective of the three chamber mixing and flush syringe assembly seen in Figure 11 with a portion of the fluid earlier disposed in the distal chamber drawn into the middle chamber .
- Figure 18 is a perspective of the three chamber mixing and flush syringe assembly seen in Figure 17 with the valved stopper displaced to abut the inner distal surface of the syringe barrel.
- Figure 19 is a perspective of the three chamber mixing and flush syringe assembly seen in Figure 18, but with a cap removed and valve of the valved stopper open for dispensing fluid from the syringe barrel.
- Figure 20 is a perspective of the three chamber mixing and flush syringe assembly, seen in Figures 18 and 19, with the valve assembly nested into recesses of the valved stopper and with both valves open to permit dispensing of a flush from the most proximal chamber the barrel.
- Figure 21 is a perspective of the three chamber mixing and flush syringe assembly, seen in Figure 20, with fluid from the most proximal chamber dispensed, but with the plunger retained at a non-abutting distance from the valve assembly to guard against reflux.
- Figure 22 is a perspective of a two chamber mixing syringe assembly similar to the syringe assembly seen in Figures 1-8, but having a valved stopper molded with a dome inverted relative to the valved stopper seen in Figures 1-8.
- Figure 23 is a perspective of a syringe assembly similar to the syringe assembly seen in Figure 22 with a valve of a valved stopper disposed in an open state, the valved stopper being displaced proximally relative to the valved stopper seen in Figure 22.
- Figure 24. is a distal perspective of the valve stopper of the syringe assembly seen in Figures 22 and 23 which separates a more distal chamber from a more proximal chamber in Figure 22.
- Figure 25 is a distal perspective of the valve stopper seen in Figures 22-24 with a valve of the valved stopper disposed in an open state.
- Figures 1-25 wherein like numerals are used to designate like parts throughout. Note that Figures 1-21 generally disclose elements associated with a first embodiment of the instant invention while Figures 22-25 disclose elements associated with a second embodiment of the instant invention.
- FIG. 1 wherein a two chamber mixing syringe assembly 10 made according to the instant invention is seen.
- Mixing syringe assembly 10 is assembled using a conventional syringe 20 which comprises a traditional elongated, cylindrical barrel 30, a stem 40 and a plunger 50 associated with stem 40.
- Plunger 50 is disposed within a hollow cylinder 60 of barrel 30 and is sufficiently close fitting to be fluid tight and wipe liquid from an inner surface 70 of cylinder 60 when displaced through barrel 30. Further, barrel 30 is closed at a distal end 80, except for a fluid dispensing orifice 90 (seen in Figures 9 and 10) . Note, that distal end 80 has an interior surface 92 which is contoured to maximize effluent flow and minimize dead space to thereby minimize fluid retained in barrel 30 as a plunger or stopper is displaced to abut distal end 80.
- orifice 90 is closed and sealed by a removable cap 100.
- orifice 90 and cap 100 have associated luer and luer-lock fittings for fluid tight connection.
- Valved stopper 110 Disposed within barrel 30 between plunger 50 and interior surface 92 is a valved stopper 110.
- Valved stopper 110 divides space within barrel 30 into two chambers (i.e. distal chamber 120 and proximal chamber 130) .
- proximal chamber 130 is seen to be much smaller in Figure 1 than distal chamber 120, such is not necessarily always the case.
- the relative size of chamber 120 to chamber 130 may vary dependent upon concentrations and quantities of material to be mixed.
- contents of chamber 120 include a liquid 150 (usually a diluent) and a small amount of gas 160 (likely air and diluent vapor) .
- Smaller chamber 130 may contain a lyophilized solid and gas or a fluid. Contents of chamber 130, either the lyophilized solid or a fluid, are destined to be diluted by liquid 150 from chamber 120.
- Gas 160 may be small in volume compared to liquid 150, but it is prudent to have that small elastic material volume in chamber 120 to facilitate creation of negative pressures in chamber 120 during the mixing process.
- valved stopper 110 comprises a medially disposed dome 170 which has a concave surface 172, relative to distal side 162. Centrally disposed across dome 170 is a slit 180, which remains closed when a positive pressure gradient of a predetermined magnitude (measured from proximal side 182 to distal side 162) is imposed thereupon. Dome 170 is better seen in Figure 4A to comprise a convex proximal surface 184 juxtaposed concave surface 172.
- proximal side 182 comprises a cylindrical inner surface 186 which forms a hollow well 188 leading to dome 170.
- Valved stopper 110 comprises a ribbed cylindrical exterior surface 190 which is sized and shaped to fit into barrel 30 and displace fluids within into barrel 30 in the same manner as plunger 50.
- valved stopper 110 When a negative pressure gradient is imposed upon valved stopper 110, by displacing stem 40 in direction of arrow 140 (see Figure 1) , that negative pressure is also disposed across dome 170. Under such conditions, dome 170 "balloons" and slit 180 opens to permit a portion of the fluid (liquid 150 and gas 160) disposed in chamber 120 to pass into chamber 130.
- valved stopper 110 abuts distal interior surface 92, as seen in Figure 8.
- distal face 162 of valved stopper 110 is contoured to minimize dead space and, thereby, maximize mixing of contents of chambers 120 and 130.
- Cap 100 is securely but releasibly affixable to syringe barrel 30.
- Syringe barrel 30 is the form of a cylinder (hollow cylinder 60) of substantially constant diameter.
- Valved stopper 110 fits into barrel 30 in a' manner similar to the way plunger 50 fits into barrel 30.
- Plunger 50 is either affixed to stem 40 prior to insertion of plunger 50 into barrel 30 or is attached just before use as is disclosed hereafter. Special attention should be made to form of a distal portion 192 of plunger 50, which is better seen in Figure 7.
- plunger 50 has a cylindrical ribbed exterior surface (numbered 194 in Figures 3 and 7) which provides a fluid tight interface with interior barrel surface 60.
- portion 192 comprises a solid cylindrical section 196 which is sized and shaped to nest within well 188 (see Figure 5) .
- portion 192 abruptly ends in a distal front face 198 which is shaped and contoured to fit against a proximal face portion 200 of well 188 of which stopper 110 (again, see Figure 5) to thereby dispense any remaining fluid from well 188 when portion 192 is completely nested therein.
- dome 170 inverts under force of a predetermined positive pressure gradient to an inverted or switched state as seen by examples of domes 170 and 170* in Figures 6 and 6A.
- portion 192 has a nose section 202 (again see Figure 7) seen to be medially, distally protruding out of face portion 200.
- Portion 200 is sized and shaped to fit within a hollow formed by inverting dome 170 or 170' to thereby expel remaining fluid therefrom when portion 192 is completely nested therein.
- valved stoper 110 When valved stoper 110 is displaced to abut distal end 92 as seen in Figure 8, dome 170 and slit 180 are initially disposed as seen in Figures 4 and 4A.
- a predetermined positive pressure gradient disposed across valved stopper 110 when valved stopper 110 is abutting distal end 92, displaces or switches dome 170 to a second state (seen in Figures 6 and 6A) .
- cap 100 is removed from syringe 20 before applying a force upon stem 40 which provides the pressure gradient to switch either dome 170 or 170'.
- cap 100 is removed preparatory to dispensing fluid from barrel 30. As seen in
- dome 170' there may be fluids, disposed within chamber 130 after completing an initial mixing step, for which additional agitated mixing is desired.
- design of a dome such as dome 170' seen in Figure 6A, may be used.
- Dome 170' has a thinned area 204 disposed about a slit 180'.
- material of thinned area 204 collapses to form a "duck-bill" like valve 206. So formed, valve 206 opens to a positive pressure gradient across associated valved assembly 110 and closes when an imposed pressure gradient is either negative or zero.
- cap 100 is removed and fluid is dispensed in the same manner as with a conventional, single-chamber, syringe. While, in the case of a dome 170', valved stopper 110 and plunger 50 are already nested and operate as a single plunger part to dispense fluid from chamber 120. In the case of dome 170 (see Figure 9), plunger 50 is distally displaced in direction of arrow 210 to dispense mixed fluid through valved stopper 110.
- FIG. IA wherein stem 40 (see Figure 1) is removed from plunger 50.
- a biasing memory element e.g. in the form of spring 212
- Spring 212 is kept in place by a clip 214 affixed in bayonet fashion to flanges 216 of syringe barrel 20. So disposed, spring 212 maintains sufficient pressure across dome 170 to keep slit 180 closed, under shipping, storage and other conditions prior to use.
- clip 214 and spring 212 are removed before use and stem 40 is affixed to plunder 50.
- FIG. 11 wherein a three chamber, combination mixing and flushing syringe assembly 300 is seen.
- the combination forming syringe assembly 300 is assembled using a conventional syringe 20 which comprises a traditional elongated, cylindrical barrel 30, a stem 40 and a plunger 50' associated with stem 40.
- plunger 50' is disposed within a hollow cylinder 60 of barrel 30 and is sufficiently close fitting to be fluid tight and wipe liquid from inner surface 70 of cylinder 60 when displaced through barrel 30. Further, barrel 30 is closed at a distal end 80, except for a fluid dispensing orifice 90 (seen in Figures 13 and 19-21) .
- distal end 80 has an interior surface 92 which is contoured to maximize effluent flow and minimize dead space to thereby minimize fluid retained in barrel 30 as a plunger (when there is no intermediate valved stoppers) is displaced to abut distal end 80.
- orifice 90 is closed and sealed by removable cap 100.
- orifice 90 and cap 100 have associated luer and luer-lock fittings for fluid tight connection, as anticipated supra.
- valved stopper 110 Disposed within barrel 30 between plunger 50 ' and interior surface 92 is a valved stopper 110.
- valved stopper 110 divides space within barrel.30 into two chambers (i.e. chamber 120 and chamber 130) .
- Chamber 130 is further divided, by a valve assembly 310, into a middle chamber 130' and a most proximal chamber 320.
- a chamber proximally disposed relative to chamber 120 such as chamber 130', is seen to be much smaller in Figure 11 than chamber 120, such is not necessarily always the case.
- the relative size of chamber 120 to chamber 130' may vary dependent upon concentrations and volumes of solutions to be mixed.
- stem 40 (and plunger 50' and valve assembly 310) are displaced in the direction of arrow 140.
- contents of chamber 120 include a liquid 150 (usually a diluent) and a necessary small amount of gas 160 (likely air and diluent vapor).
- Smaller chamber 130' may contain a lyophilized solid and gas or a fluid. Each of the lyophilized solid or the fluid is destined to be diluted by liquid 150 from chamber 120.
- Gas 160 may be small in volume compared to liquid 150, but it is prudent to have that small volume to facilitate creation of negative pressures in chamber 120 during the mixing process.
- valve assembly 310 operates in a manner identical to a valve assembly disclosed in Thorne, Jr. (referenced as valve assembly 550, therein).
- Valve assembly 550 is assembled using a valved stopper 580 and a separator 700, as numbered in Thorne, Jr.
- a flush syringe employing valve assembly 550 may be used in a manner identical to a standard or conventional syringe.
- valve assembly 310 and fluid content 330 in most proximal chamber 320 may, operationally relative to displacement of valved stopper 110, be considered to be a mechanical extension of plunger 50'.
- valve assembly 310 is assembled using a valved stopper 340 and a separator 370.
- a singular difference between valved stopper 340 and valved stopper 580 as disclosed in Thorne, Jr. is an elongated front section 350 of valved stopper 340' as seen in Figures 14-16.
- Front section 350 is sized and shaped to nest within well 188 (see Figures 4A and 5) as portion 192 of plunger 50 so nests in syringe assembly 10 (see Figures 8A and 10) .
- valved stopper 340 comprises a bi-stable slit valve 376 having a dome 374 which inverts when switched (see Figure 14 prior to switching and Figure 16 after switching) .
- a switched dome 374 provides a bulbous protrusion of front section 350 which expels fluid from well 188, in the same manner that nose section 202 does for plunger 50.
- Gas separator 370 is functionally identical to separator 700 of Thorne, Jr.
- Plunger 50' preferably has a flat or planar distal face 380.
- Valved stopper 110 is displaced into barrel 30 to close most distal chamber 120, followed by insertion of valve assembly 310 (made from valved stopper 340 and separator 370) to form middle chamber 130' and, finally, insertion of plunger 50' to close most proximal chamber 320.
- Chambers 120, 130' and 320 are seen in Figure 12.
- Separator 370 is seen assembled into valved stopper 340 in Figure 15.
- Valved stoppers 110 and 340 are seen in Figure 16 with domes 170 and 374 inverted to a second state with slits 180 and 376 open. Such is the case, when liquid is being dispensed from chamber 320 as seen in Figures 20 and 21 and disclosed in more detail hereafter.
- volume of fluid in middle chamber 130' is seen to be increased from volume of material in chamber 130' in Figure 11 by successive pulls in direction of arrow 140 of stem 40.
- volume of chamber 320 in Figure 17 is substantially the same as volume of chamber 320 in Figure 11. This is because there is no material change in chamber 320 resulting from success pulls on stem 40.
- valved stopper 110 is displaced, by successive pulls on stem 40, to abut distal end 80 of syringe barrel 30.
- cap 100 is removed, as seen in Figure 19.
- dome 374 is inverted (see Figure 16) and slit 376 is opened to permit emptying of chamber 320 as seen in Figure 20.
- substantially all fluid desired to be effluent is dispensed as seen in Figure 21. Note, that plunger 50' is not in contact with valve assembly 310 at the end of the dispensing cycle.
- FIG. 22-25 An alternate embodiment of a mixing syringe assembly 400 is seen in Figures 22-25.
- a material to be mixed or diluted is initially disposed in a distal chamber 120.
- a diluent is disposed in a more proximal chamber 130, just opposite of the material/diluent disposition of Figures 1—21.
- mixing dispositions and methods disclosed for this embodiment are applicable to associated dispositions and methods disclosed for syringe assemblies 10 and 10", supra.
- a simple change in geometry or operation in a valved stopper provides for changes in operative procedures disclosed hereafter.
- FIG. 22 wherein a mixing syringe assembly 400 is seen.
- a material to be diluted is disposed in chamber 120 between a valved stopper 170" and interior surface 92 of distal end 80 of syringe 20.
- a diluent is disposed in chamber 130 between valved stopper 170" and a plunger 50. It is important to note that plunger 50 and valved stopper 170" have the same nesting characteristics as disclosed supra for plunger 50 and stopper 110.
- distal end 80 of syringe 20 has an interior surface 92 which is contoured to maximize effluent flow and minimize dead space to thereby minimize fluid retained in barrel 30 as a plunger or stopper is displaced to abut distal end 80.
- orifice 90 is closed and sealed by a removable cap 100.
- orifice 90 and cap 100 have associated luer and luer-lock fittings for fluid tight connection.
- Valved stopper 110' Disposed within barrel 30 between plunger 50 and interior surface 60 is a valved stopper 110'.
- Valved stopper 110' divides space within barrel 30 into two chambers (i.e. distal chamber 120 and proximal chamber 130) .
- chamber 120 is seen to be much smaller in Figure 22 than distal chamber 130, as the diluent is anticipated to be stored in chamber 130. Such is not necessarily always the case.
- the relative size of chamber 130 to chamber 120 may vary dependent upon concentrations and quantities of material to be mixed. To mix fluids contained in chamber 130 with material contained in chamber 120, stem 40 (and plunger 50) are displaced in the direction of arrow 210.
- contents of chamber 130 include a liquid 150 (usually a diluent) and a small amount of gas 160 (likely air and diluent vapor) .
- Smaller chamber 120 may contain a lyophilized solid and a necessary volume of gas 402 or a fluid and gas 402. Contents of chamber 120, either the lyophilized solid or a fluid, are destined to be diluted by liquid 150 from chamber 130.
- Gas 402 may be small in volume compared to other contents of chamber 120, but it is prudent to have that small elastic material volume in chamber 120 to facilitate the mixing process .
- valved stopper 110' comprises a medially disposed dome 170" which has a convex surface 172', relative to distal side 162'. Centrally disposed across dome 170" is a slit 180', which remains closed when a negative or zero pressure gradient (measured from proximal side 182 ' to distal side 162') is imposed thereupon.
- valved stopper 110' has the same physical dimensions and characteristics as those of valved stopper 110.
- a positive pressure gradient is imposed upon valved stopper 110', by displacing stem 40 in direction of arrow 210 (see Figure 22) that negative pressure is also disposed across dome 170".
- dome 170" "balloons” and slit 180' opens to permit a portion of the fluid (liquid 150 and gas 160) disposed in chamber 130 to pass into chamber 120.
- valved stopper 110' abuts plunger 50, as seen in Figure 23.
- cap 100 is removed.
- valve, associated with dome 170" there is no need for the valve, associated with dome 170", to be switched to a second state, other than an open state in this embodiment, to dispense fluids from syringe 20.
- valved stopper 110' there is substantially no fluid yet to be displaced through valved stopper 110', as valved stopper 110' is then displaced to abut plunger 50. Therefore, cap 100 simply has to be removed and stem 40 and plunger 50 displaced distally to dispense mixed fluid from mixing syringe assembly 400.
- a negative pressure bias is best used to keep material in chambers 120 and 130 disparate during shipping, handling and otherwise before use.
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/US2007/001848 WO2008091251A2 (en) | 2007-01-23 | 2007-01-23 | Mixing syringe with and without flush |
BRPI0721175-9A BRPI0721175A2 (en) | 2007-01-23 | 2007-01-23 | mixing syringe apparatus and method for using a mixing syringe apparatus |
CA002676248A CA2676248A1 (en) | 2007-01-23 | 2007-01-23 | Mixing syringe with and without flush |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/US2007/001848 WO2008091251A2 (en) | 2007-01-23 | 2007-01-23 | Mixing syringe with and without flush |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2008091251A2 true WO2008091251A2 (en) | 2008-07-31 |
WO2008091251A3 WO2008091251A3 (en) | 2009-04-16 |
Family
ID=39644979
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2007/001848 WO2008091251A2 (en) | 2007-01-23 | 2007-01-23 | Mixing syringe with and without flush |
Country Status (3)
Country | Link |
---|---|
BR (1) | BRPI0721175A2 (en) |
CA (1) | CA2676248A1 (en) |
WO (1) | WO2008091251A2 (en) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2011035252A1 (en) | 2009-09-18 | 2011-03-24 | Ams Research Corporation | Cell-based therapy and delivery systems and methods |
EP4223265A1 (en) * | 2010-04-27 | 2023-08-09 | Smith & Nephew plc | Wound dressing |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3767085A (en) * | 1971-08-02 | 1973-10-23 | J Cannon | Mixing syringe |
US4861335A (en) * | 1985-07-26 | 1989-08-29 | Duoject Medical Systems Inc. | Syringe |
US5360410A (en) * | 1991-01-16 | 1994-11-01 | Senetek Plc | Safety syringe for mixing two-component medicaments |
US5643218A (en) * | 1994-02-15 | 1997-07-01 | Lawrence A. Lynn | Auto-flushing medical fluid injection system |
US7101354B2 (en) * | 2004-05-03 | 2006-09-05 | Infusive Technologies, Llc | Mixing syringe with and without flush |
-
2007
- 2007-01-23 CA CA002676248A patent/CA2676248A1/en not_active Abandoned
- 2007-01-23 WO PCT/US2007/001848 patent/WO2008091251A2/en active Application Filing
- 2007-01-23 BR BRPI0721175-9A patent/BRPI0721175A2/en not_active IP Right Cessation
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3767085A (en) * | 1971-08-02 | 1973-10-23 | J Cannon | Mixing syringe |
US4861335A (en) * | 1985-07-26 | 1989-08-29 | Duoject Medical Systems Inc. | Syringe |
US5360410A (en) * | 1991-01-16 | 1994-11-01 | Senetek Plc | Safety syringe for mixing two-component medicaments |
US5643218A (en) * | 1994-02-15 | 1997-07-01 | Lawrence A. Lynn | Auto-flushing medical fluid injection system |
US7101354B2 (en) * | 2004-05-03 | 2006-09-05 | Infusive Technologies, Llc | Mixing syringe with and without flush |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2011035252A1 (en) | 2009-09-18 | 2011-03-24 | Ams Research Corporation | Cell-based therapy and delivery systems and methods |
EP4223265A1 (en) * | 2010-04-27 | 2023-08-09 | Smith & Nephew plc | Wound dressing |
Also Published As
Publication number | Publication date |
---|---|
CA2676248A1 (en) | 2008-07-31 |
WO2008091251A3 (en) | 2009-04-16 |
BRPI0721175A2 (en) | 2013-01-29 |
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