WO2005065752A1

WO2005065752A1 - Syringe assembly with shut off valve

Info

Publication number: WO2005065752A1
Application number: PCT/US2004/042722
Authority: WO
Inventors: Philip J. Simpson; Walter Dean Gillespie; David G. Matsuura
Original assignee: Vasogen Ireland Limited
Priority date: 2003-12-30
Filing date: 2004-12-21
Publication date: 2005-07-21
Also published as: WO2005065752B1; TW200528155A; HK1077155A2; AR047783A1; CN2812955Y; WO2005065752A8

Abstract

Disclosed herein is a syringe assembly comprising a barrel (12) with an outlet portion (14), the outlet portion including an outlet passage (16), a plunger (18) slidably mounted in the barrel and valve means (20) for controlling the transfer of material through the outlet passage, the valve means including a valve portion (22) movable along the barrel between a first position within the outlet passage to block transfer of material there through and a second position to allow transfer of material through the outlet passage; and valve actuating means (24) mounted on the barrel for movement relative to a neutral position to displace the valve portion between the first and second positions.

Description

SYRINGE ASSEMBLY WITH SHUT OFF VALVE

BACKGROUND OF THE INVENTION

FIELD OF THE INVENTION The present invention relates to syringes assemblies and more particularly to those having an outlet passage that can be opened or closed under certain operative conditions.

DESCRIPTION OF THE RELATED ART Syringe assemblies are commonly used to deliver medications and other biological fluids to a patient. The syringe assembly typically has a plunger which is sealingly engaged with a barrel to form an inner fluid- receiving chamber. The chamber has a delivery outlet passage which is typically provided with a 'male' luer fitting to form a fluid coupling with a female luer fitting on a needle assembly or the like. The delivery outlet passage is usually open, so that when the needle is removed, the cavity is open to the environment. This is problematic since many medications and biological fluids are sensitive (or can degrade when exposed) to the environment. Devices are available, such as those disclosed in WO publication number WO03013646A2 which close the outlet passage of an IN device when the latter is disconnected from a mating device, such as a needle. While devices like this can be used to control an outlet passage on an IN device, there are circumstances where it is desirable to control the outlet passage of a syringe assembly independent of whether it is attached to another IN delivery device, for instance. It is therefore an object of the present invention to provide a novel syringe assembly.

SUMMARY OF THE INVENTION In one of its aspects, the present invention provides a syringe assembly comprising a barrel with an outlet portion, the outlet portion including an outlet passage, a plunger slidably mounted in the barrel and valve means for controlling the transfer of material through the outlet passage, the valve means including a valve portion movable along the barrel between a first position within the outlet passage to block transfer of material through the outlet passage and a second position to allow transfer of material there through; and valve actuating means mounted on the barrel for movement relative to a neutral position to displace the valve portion between the first and second positions. In one embodiment, the valve portion is located within the outlet passage in both the first and second positions. The barrel has an outer surface and the actuating means includes a hand grip formation located on the outer surface. At least a portion of the hand grip formation is displaceable along the barrel in reaction to forces exerted thereon by a user while displacing the plunger. The valve actuating means is operable to displace the valve portion with a corresponding displacement of the hand grip formation. Conveniently, in one embodiment, the plunger has a cylindrical plunger body with an inner remote end portion. The inner remote end portion includes a sealing means for sealing the plunger body with the barrel to form a material receiving chamber. The inner remote end portion is also provided with a central bore and the valve stem extends from the valve portion, through the bore and into the plunger body. The plunger body has a number of symmetrically opposed slots, each to receive one of a number of coupling members extending between the valve stem and the hand grip formation. The coupling members are operable to adjust the position of the valve stem according to the position of the hand grip formation relative to the neutral position. Preferably, the coupling members are operable to displace the valve stem, thereby to displace the valve portion from the first position toward the second position to an extent proportional to the displacement of the hand grip formation from the neutral position. Preferably, the barrel has a side wall which has a number of passages, each to receive a corresponding coupling member. A region of the side wall adjacent each passage operates as a fulcrum against which the coupling member rotates with a corresponding displacement of the hand grip formation. In one embodiment, the spring means biases the valve portion toward the first position. In this case, the spring means includes a spring flange having opposed ends, each end extending through a corresponding passage in the side wall. The coupling members are formed on opposed ends of a coupling flange and this coupling flange is integrally formed with the spring flange. A support block member is positioned between the coupling flange and the spring flange and is operable to brace the coupling member to deflect the spring flange when the hand grip formation is displaced away from the outlet passage. In this case, deflection of the spring flange causes the valve stem to be displaced toward the second position while the hand grip formation deflects the coupling flange when the hand grip is displaced toward the outlet passage, thereby to cause the valve stem to be displaced toward the second position. In an embodiment, the plunger has an inner chamber with a longitudinal axis. The valve actuation means includes a diaphragm portion mounted in the plunger chamber and movable along the longitudinal axis. The diaphragm member moves according to changes in forces exerted thereon. Preferably, the diaphragm portion is responsive to an external force generating means, such as a hand grip formation, mounted to be movable relative to a neutral position. Alternatively, the diaphragm portion is responsive to other forces which could include, for example, hydraulic or pneumatic forces exerted thereon by a fluid contained in the plunger body. In another embodiment, the valve portion is rotatable about a longitudinal axis of the barrel between the first and second positions. In this case, the valve portion is positioned in the outlet passage in both the first and second positions. Preferably, the outlet portion includes at least one flow opening and the valve portion is provided with at least one material transfer passage which, in the second position is in fluid communication with the flow opening. The valve actuating means includes a sleeve member movably mounted relative to the barrel portion, under the action of a user-delivered force, for displacing the valve portion between the first and second positions. The sleeve member includes at least one inner guide portion and the valve portion includes a follower which is entrained with the inner guide portion for rotational movement with a corresponding longitudinal displacement of the inner guide portion thereby to cause a corresponding rotational displacement of the valve portion between the first and second positions. In a further aspect, the present invention provides a syringe assembly comprising a barrel with an outlet portion, the outlet portion including an outlet passage, a plunger slidably mounted in the barrel and valve means for controlling the transfer of material through the outlet passage, the valve means including a valve member extending from a location within the outlet passage to a remote location inside the barrel and valve actuating means for displacing the valve member between a first position in which the valve member blocks the outlet passage and a second position spaced from the first position in response to an externally applied reaction force. In a further aspect, the present invention provides a syringe assembly comprising a barrel with an outlet portion, the outlet portion including an outlet passage, a plunger slidably mounted in the barrel and valve means for controlling the transfer of material through the outlet passage, the valve means including a valve member extending from a location within the outlet passage to a remote location inside the barrel and valve actuating means for displacing the valve member between a first position in which the valve member blocks the outlet passage and a second position spaced from the first position, the valve actuating means operable to maintain the valve member in the first position when the syringe assembly is in a neutral condition. In a further of its aspects, the present invention provides a method of controlling a syringe assembly of the type having a barrel and a plunger operatively associated therewith to form a materials receiving chamber and an outlet passage for dispensing materials from the chamber, comprising the step of blocking the outlet passage with a valve portion when the syringe assembly is in a neutral condition and providing a valve actuator which is operable to move the valve portion to open the outlet passage when the syringe assembly is placed in a condition other than the neutral condition. In still another of its aspects, the present invention provides a method for controlling the dispensing of materials from a syringe comprising the steps of: - providing a barrel with an outlet portion, the outlet portion including an outlet passage, - slidably mounting a plunger within the barrel; - locating a valve portion within the outlet passage to be movable between a first position to block transfer of material through the outlet passage and a second position to allow transfer of material through the outlet passage; - providing the valve portion with a valve stem extending into the barrel and through a passage in the plunger; - providing a formation on the exterior of the barrel and joining the formation with the valve stem in a manner which maintains a material receiving cavity between the plunger and the barrel, and - arranging the formation to move relative to a neutral position to cause a corresponding displacement of the valve portion from the first position to open the passage.

BRIEF DESCRIPTION OF THE DRAWINGS Several preferred embodiments of the present invention will now be described, by way of example only, with reference to the appended drawings in which: Figures 1 and la are side and end views, respectively, of a syringe assembly; Figure 2 is a perspective view of the syringe assembly of figure 1; Figure 3 is a sectional view of the syringe assembly of figure 1 in a first operative condition; Figure 3 a is a magnified sectional view taken on circle 3 a of figure 3; Figure 4 is a sectional view of the syringe assembly of figure 1 in a second operative condition; Figure 4a is a magnified sectional view taken on circle 4a of figure 4; Figure 5 is a sectional view of the syringe assembly of figure 1 in a third operative condition; Figure 5a is a magnified sectional view taken on circle 5a of figure 5; Figure 6 is an end view of an alternative syringe assembly; Figure 6a is a sectional view taken on line A- A of figure 6; Figure 6b is another sectional taken on line A-A of figure 6 with the syringe assembly in another operative condition. Figures 7a, 7b, 8, 9 and 10 are sectional views of other alternative syringe assemblies taken with reference to line A-A of figure 6; Figure 11 is a fragmentary perspective view of still another alternative syringe assembly; Figure 1 la is a magnified view taken on circle 13a figure 13; Figure 12 is a fragmentary perspective view of the syringe assembly of figure 13 in a first operative condition; Figure 13 is a fragmentary perspective view of the syringe assembly of figure 13 in a second operative condition; and Figure 14 is a fragmentary perspective view of the syringe assembly of figure 13 in a third operative condition; DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to figures 1, la, 2 and 3, a syringe assembly is provided at 10 with a barrel 12 having an outlet portion 14 and an outlet passage 16. A plunger 18 is slidably mounted in the barrel 12 and valve means, generally shown at 20 in figure 3, is provided for controlling the transfer of material through the outlet passage 16. As will be described in more detail below, the valve means 20 has a valve portion 22 which is movable between a first position (as shown in figures 3 and 3 a) in which it blocks the transfer of material through the outlet passage 16 and a second position (shown in figures 4 and 4a) in which the valve portion 22 allows the transfer of material through the outlet passage 16. A particular feature of the syringe assembly 10 is its use of a valve actuating means generally shown at 24 in figures 2 and 3, which is movable from a neutral position to dislodge the valve portion 22 from its first position, thereby to open the outlet passage 16. Referring to figures 2 and 3, the barrel 12 has an outer surface 30 and the valve activation means includes a hand grip formation 32 which is interconnected with the valve portion 22 in a manner to be described. The hand grip formation 32 may be flexed, shifted or otherwise displaced from its neutral position to cause a corresponding change in the condition of the valve portion 22. Referring to figure 3, the plunger 18 has a cylindrical plunger body 36 with an inner remote end portion 38 and an outer end cap 39. The inner remote end portion 38 includes an annular sealing member 40 which seals plunger body 36 with the barrel 12 to form a material receiving chamber 42. The valve portion 22 is located in the outlet passage 16 and a valve stem 52 is joined thereto. The inner remote end portion 38 and the sealing member 40 have aligned central bores 54, 56 to receive the valve stem 52. In this case, the valve stem 52 extends from the valve portion 22, through the cenfral bores 54, 56 and into the plunger body 36 to a region near the hand grip formation 32. In this case, the valve portion 22 and the valve stem 52 are formed in a uniform one piece fashion, although each may be separate and/or distinct in other applications. Referring to figures 2 and 3, the plunger body 36 has three symmetrically opposed slots 58. Each slot 58 receives one of three coupling members 60 which join the valve stem 52 and the hand grip formation 32. The coupling members 60 and the valve stem 52 remain generally stationary, apart from the nominal displacement relative to the barrel 12, during activation of the valve means 20. Thus, the slots 58 extend along the plunger body to a degree sufficient to allow the plunger body 36 to be displaced along the barrel 12 while maintaining the connection between the hand grip formation 32 and the valve stem 52. Referring to figure 2, the barrel 12 has a side wall 62 which has three notched open passages 64, each with an open sector 64a and an offset seating sector 64b which provides a location for the hand grip formation 32 when installed on the barrel 12. This is done by passing each coupling member 60 through a corresponding open sector 64a and thereafter shifting the coupling members 60 into a corresponding seating sector 64b. The side wall 62 provides a first boundary 62a (figure 3) and a second boundary 62b which border opposite ends of the seating sector 64b. The side wall 62 in the vicinity of the first boundary 62a functions as a fulcrum against which each coupling member 60 rotates with a corresponding displacement of the hand grip formation 32. This rotation can be seen by comparing the views of figures 3 and 4. Thus, the coupling members 60 are operable to adjust the position of the valve stem 52 according to the position of the hand grip formation 32 relative to its neutral position, such as that occurring when free from contact with a user's hand and thus under a no-load condition. The hand grip formation 32 may be in this neufral position regardless of the position of the plunger 18 and one example of such neutral position is shown in figure 3. It will also be seen that the coupling members 60 are operable to displace the valve stem 52, thereby to displace the valve portion 22 from the first (closed) position toward the second (open) position to an extent proportional to the displacement of the hand grip formation from the neutral position. Thus, it can be said that, in this arrangement, the syringe assembly 10 is in a neutral condition and, hence, the valve means is operable to close the outlet passage when the syringe assembly is in a condition other than the neufral condition. Referring to figure 3, spring means 66 is provided to bias the valve portion 22 toward its first position, thereby to close the outlet passage 16. In this case, the spring means 66 includes a spring flange 68 having opposed ends 68a, 68b, each end extending through a corresponding seating sector 64b. The coupling members 60 are formed on opposed ends of a coupling flange 70 which is integrally formed with the spring flange 68 on opposite sides of support block member 72. The opposed ends 68a, 68b of the spring flange 68 are of similar cross sectional shape to the coupling members 60 at the location where each passes through a corresponding seating sector 64b. Each coupling member 60 extends laterally outwardly beyond the seating sector 64b to the hand grip formation 32, which in this case is a peripheral ring member, but may be of other configurations as desired. In contrast, the opposing ends 68a, 68b of the spring flange 68 terminate just past the seating sector 64b and lie against the second boundary 62b on the side wall 62. The function of the hand grip formation 32 is best understood by considering two operational modes. First, when the user wishes to draw materials into the syringe assembly 10, he "pulls" with one hand the plunger 18 with one hand outwardly from the barrel 12. To do so, the user grips the hand grip formation 32 with the other hand, delivering a downward force thereto as seen in figure 4. This has the effect of "pushing" the hand grip formation 32 toward the outlet passage 16. The central area of the coupling flange 70 is thus deflected upwardly, thus displacing the valve portion 22 toward the second position to open the outlet passage, as best seen in the magnified view of figure 4a. Alternatively, when the user wishes to dispense materials from the syringe assembly 10, he "pushes" the plunger 18 to travel inwardly along the barrel 12, thereby delivering a downward force to the plunger as shown in figure 5. In so doing, the user grips the hand grip formation 32, thereby delivering an upward reaction force thereto. The upward force causes the coupling flange 70 to flex upwardly and contact the support block member 72 which in turn exerts an upward force to the spring flange 68, thereby causing an upward displacement of the central region of the spring flange 68, while its opposite end regions 68a, 68b are pressed against the side wall 62b in the region of the seating sector 64b. This in turn causes an upward displacement of the valve stem 52 and hence causes the valve portion 22 to open the outlet passage. Therefore, despite the fact that the hand grip formation 32 is displaced in opposite directions along the barrel 12, such movement in both directions causes the valve portion 22 to open the outlet passage 16. In either case, after the plunger 18 is brought to rest and the forces causing the displacement are removed, the coupling member 60 travels back to its default or neufral position of figure 3 and this in turn causes the valve portion 22 also to return to its default closed first position to close the outlet passage, as can be seen in figure 3 a. It can be seen that the coupling flange 70 functions as a diaphragm mounted within the plunger 18 and movable along a longitudinal axis thereof. The coupling flange 70 flexes according to changes in forces exerted thereon. The actuating forces may be exerted on the coupling flange in different ways, such as by the use of other hand grip formations moveable laterally, both laterally and longitudinally relative to the plunger. In addition, the hand grip formation may be replaced by other reactive force generating means such as those capable of generating hydraulic or pneumatic pressures thereon. As can be seen in figures 4 and 4a, the valve portion 22 has a distal end 22a which is bevelled to complement a conical end region 16a of the outlet passage 16. Figures 6, 6a and 6b illustrate an alternative embodiment with a valve portion 80 having a distal end 80a seated in a notched end region 82a of the outer passage 82. Figure 6b shows the outlet passage 82 opened when the valve portion 80 is displaced outwardly (rather than inwardly as in the valve portion 22 of the syringe assembly 10) and figure 6a shows the outlet passage 82 closed. Figures 7a and 7b illustrate another embodiment with a valve portion 84 having a distal end 84a seated against an inwardly tapered conical end region 86a of the outlet passage 86. In this case, the valve portion 84 provides a transfer notch recess 84b on one side thereof which allows access to the outlet passage 84 when the valve portion is moved outwardly. Figures 8, 9 and 10 illustrate a further embodiment with a valve portion 88 having a distal end 88a seated against a cylindrical cross sectioned end region 90a of the outlet passage 90, thus permitting the valve portion 86 to move inwardly or outwardly to open the outlet passage 88. In this case, the valve portion 86 has a region of reduced thickness 86b, allowing access to the outlet passage when the valve portion 86 is either outwardly or inwardly displaced from the end region 88 a. Another syringe assembly is shown at 100 in figures 11 and 12 to 14 having a barrel 102 and a plunger 103 sealingly engaged therewith. The barrel 102 provides an outlet portion 104 carrying a valve portion 106 in an outlet passage 107. The outlet portion 104 has a perforated end plate 108 providing a number of flow outlets 110. Similarly, the valve portion 106 has a number of longitudinally oriented flow paths 112 which are aligned with the flow outlets 110. The valve portion 106 is rotatable about a longitudinal axis of the barrel 102 between and/or through two positions, a first in which the flow paths 112 are aligned with the flow outlets 110 to open the outlet passage 107 and a second position in which the flow paths 112 are misaligned with the flow outlets 110, thus closing the outlet passage 107. The syringe assembly 100 has valve actuating means shown at 114 in figure 12 which includes a sleeve member 116 movably mounted relative to the barrel 102. The sleeve member 116 includes an inner guide portion 118 which has a pair of helical paths 120 as best shown in figure 13. The valve portion 106 is integrally formed with a valve stem 122 which extends through a sealed remote end 103 a of the plunger 103 and into an interior region of the barrel 102. The plunger 103 has a cenfral passage along its length as shown at 124 to accommodate cruciform anchor member 126 extending across the open end of the barrel 102. The barrel has a pair of passages 128 and two pairs of suspension springs 130, 132 which position the guide portion 118 centrally relative to the passages 128. Referring to figure 13, the outer end of the valve stem 122 is joined to a follower 134 which in turn is swivelled to a base formation 136 extending inwardly from the anchor member 126. The follower 134 has a pair of oppositely disposed outwardly extending tabs 138, each to be entrained within and travel along a helical path 120. Thus, as the sleeve member 116 is displaced along the barrel 102, the tabs 138 travel along the paths 120 causing a corresponding rotation of the valve stem 122 and hence the valve portion 106 to open the outlet passage 107. The sleeve member 116 may be displaced either toward the outlet passage 102 while pulling the plunger to draw materials into the syringe assembly 100 (as shown in figure 13) or away from the outlet passage 107 while dispensing materials (as shown in figure 14) and the outlet passage 102 is opened in both cases. However, when the pulling or pushing forces are released, for example when the user releases his grip on the plunger 103 and sleeve member 116, the springs 130, 132 return the sleeve to its neufral position, in turn returning the valve portion 106 to its first position to close the outlet passage. While the present invention has been described for what are presently considered the preferred embodiments, the invention is not so limited. To the contrary, the invention is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims. The scope of the following claims is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures and functions.

Claims

CLAIMS:

1. A syringe assembly comprising a barrel with an outlet portion, the outlet portion including an outlet passage, a plunger slidably mounted in the barrel and valve means for controlling the transfer of material through the outlet passage, the valve means including a valve portion movable along the barrel between a first position within the outlet passage to block transfer of material therethrough and a second position to allow transfer of material through the outlet passage; and valve actuating means mounted on the barrel for movement relative to a neufral position to displace the valve portion between the first and second positions.

2. A syringe as defined in claim 1 wherein the valve portion is located within the outlet passage in both the first and second positions.

3. An assembly as defined in claim 1 or claim 2, the barrel having an outer surface, the valve actuating means including a hand grip formation positioned on the outer surface, at least a portion of the hand grip formation being displaceable along the barrel relative to the neutral position in reaction to forces exerted thereon by a user while displacing the plunger.

4. An assembly as defined in claim 1, claim 2, or claim 3, the valve means further comprising a valve stem joined with the valve portion, the plunger further comprising a cylindrical plunger body with an inner remote end portion, the inner remote end portion including sealing means for sealing the plunger body with the barrel to form a material receiving chamber, the inner remote end portion having a cenfral bore extending therethrough to receive the valve stem.

5. An assembly as defined in claim 4, wherein the plunger body has a number of symmetrically opposed slots and a corresponding number of coupling members, each extending between the valve stem and the hand grip formation through a corresponding slot, the coupling members being operable to adjust the position of the valve stem according to the position of the hand grip formation relative to the neutral position.

6. A syringe assembly as defined in claim 5, wherein the coupling members are operable to displace the valve stem, thereby to displace the valve portion from the first position toward the second position to an extent proportional to the displacement of the hand grip formation from the neutral position.

7. An assembly as defined in claim 5 or claim 6, the barrel further comprising a side wall with a number of passages, each to receive a corresponding coupling member, a region of the side wall adjacent each passage being operable as a fulcrum against which the coupling member rotates with a corresponding displacement of the hand grip formation.

8. An assembly as defined in any preceding claim, further comprising spring means for biasing the valve portion toward the first position.

9. An assembly as defined in claim 8, wherein the spring means includes a spring flange having opposed ends, each end extending through a corresponding one of the passages in the side wall.

10. An assembly as defined in claim 9, further comprising a coupling flange having the coupling members formed on opposing ends thereof, wherein the coupling flange is integrally formed with the spring flange.

11. An assembly as defined in claim 10, further comprising a support block member positioned between the coupling flange and the spring flange, the support block member operable to deflect the spring flange when the hand grip formation is displaced away from the outlet passage thereby to cause the valve stem to be displaced toward the second position, the hand grip formation being operable to deflect the coupling flange when the hand grip formation is displaced toward the outlet passage, thereby to cause the valve stem to be displaced toward the second position.

12. An assembly as defined in claim 1 wherein the valve portion is rotatable about a longitudinal axis of the barrel between the first and second positions.

13. An assembly as defined in claim 12, wherein the valve actuating means includes a sleeve member movably mounted relative to the barrel for displacing the valve portion between the first and second positions.

14. An assembly as defined in claim 13 wherein the sleeve member includes at least one inner guide portion and the valve portion includes a follower entrained with the inner guide portion for rotational movement with a corresponding longitudinal displacement of the inner guide portion thereby to cause a corresponding rotational displacement of the valve portion between the first and second positions.

15. An assembly as defined in claim 12, claim 13, or claim 14 wherein the valve portion remains adjacent the outlet passage in both the first and second positions.

16. An assembly as defined in claim 15 wherein the outlet portion includes at least one flow opening, the valve portion having a material transfer passage which, in the second position is in fluid communication with the flow opening.

17. An assembly as defined in any preceding claim, wherein the plunger has an inner chamber with a longitudinal axis, the valve actuation means including a diaphragm portion mounted in the plunger chamber and movable along the longitudinal axis, the diaphragm member being moveable according to changes in forces exerted thereon.

18. A syringe assembly comprising a barrel with an outlet portion, the outlet portion including an outlet passage, a plunger slidably mounted in the barrel and valve means for controlling the fransfer of material through the outlet passage, the valve means including a valve member extending from a location within the outlet passage to a remote location inside the barrel and valve actuating means for displacing the valve member between a first position in which the valve member blocks the outlet passage and a second position spaced from the first position in response to an externally applied reaction force.

19. A syringe assembly comprising a barrel with an outlet portion, the outlet portion including an outlet passage, a plunger slidably mounted in the barrel and valve means for controlling the fransfer of material through the outlet passage, the valve means including a valve member extending from a location within the outlet passage to a remote location inside the barrel and valve actuating means for displacing the valve member between a first position in which the valve member blocks the outlet passage and a second position spaced from the first position, the valve actuating means operable to maintain the valve member in the first position when the syringe is in a neutral condition.