Abstract
A syringe for use with a medical injector system includes a barrel and a semi-rigid hub, the hub having an outer surface adapted to slidingly move within the barrel, and an inner surface having a continous circumferential wall. The hub further includes an annular engaging portion recessed within at least part of the continous circumferential wall forming a groove, at least one radially extendable and retractable retention member disposed at partially within a proximal cylindrical portion of the hub, and the elastometric seal engaged with a seal engaging portion on the hub and slidingly engaged with the barrel of the syringe. The semi-rigid hub and the elastomeric seal are reciprocally slidable within the barrel, and the at least one radially entendable and retractable retention member is configured to releasably engage the groove upon retraction of the plunger to permit the semi-rigid hub to be selectively withdrawn within the barrel.
Claims
1. A syringe for use with a medical injector system, comprising: a barrel having a proximal end and a distal end; a semi-rigid hub, the semi-rigid hub having: an outer surface adapted to slidingly move within the barrel, the outer surface having a seal engaging portion; an inner surface having a distal conical portion and a proximal cylindrical portion with a continuous circumferential wall extending continuously between a terminal portion of an open proximal end of the semi-rigid hub and the distal conical portion, the inner surface adapted to slidingly engage a plunger, wherein the entire continuous circumferential wall has a diameter equal to or larger than the distal conical portion and wherein an inner diameter of the continuous circumferential wall is substantially equal to an inner diameter of the open proximal end of the semi-rigid hub; an annular engaging portion recessed within at least part of the continuous circumferential wall forming a groove; at least one radially extendable and retractable retention member disposed at least partially within the proximal cylindrical portion; and an elastomeric seal engaged with the seal engaging portion on the semi-rigid hub and slidingly engaged with the barrel of the syringe, wherein the semi-rigid hub and the elastomeric seal are reciprocally slidable within the barrel, and wherein the at least one radially extendable and retractable retention member is configured to releasably engage the groove upon retraction of the plunger in a direction from the distal end toward the proximal end of the barrel to permit the semi-rigid hub to be selectively withdrawn within the barrel.
2. The syringe according to claim 1, wherein the seal comprises: an outer surface adapted to slidingly engage with the barrel of the syringe; and an inner surface adapted to engage the semi-rigid hub.
3. The syringe according to claim 1, wherein the groove extends around an entire inner circumference of the inner surface of the semi-rigid hub.
4. The syringe according to claim 1, wherein the groove extends at least partially along a circumference of the inner surface of the semi-rigid hub.
5. The syringe according to claim 1, wherein the elastomeric seal comprises an extended leading edge to increase efficiency of the elastomeric seal under pressure.
6. A syringe for use with a medical injector system, comprising: a barrel having a proximal end and a distal end; a semi-rigid hub, the semi-rigid hub having: an outer surface adapted to slidingly move within the barrel, the outer surface having a seal engaging portion; an inner surface having a distal conical portion and a proximal cylindrical portion with a continuous circumferential wall extending continuously between a terminal portion of an open proximal end of the semi-rigid hub and the distal conical portion, the inner surface adapted to slidingly engage a plunger, wherein the entire continuous circumferential wall has a diameter equal to or larger than the distal conical portion; and an annular engaging portion recessed within at least part of the continuous circumferential wall forming a groove; at least one radially extendable and retractable retention member disposed at least partially within the proximal cylindrical portion; and an elastomeric seal engaged with the seal engaging portion on the semi-rigid hub and slidingly engaged with the barrel of the syringe, wherein an inner diameter of at least a portion of the continuous circumferential wall distal of the groove is substantially equal to an inner diameter of the open proximal end of the semi-rigid hub, wherein the semi-rigid hub and the elastomeric seal are reciprocally slidable within the barrel, and wherein the at least one radially extendable and retractable retention member is configured to releasably engage the groove upon retraction of the plunger in a direction from the distal end toward the proximal end of the barrel to permit the semi-rigid hub to be selectively withdrawn within the barrel.
7. The syringe according to claim 6, wherein the groove extends at least partially along a circumference of the inner surface of the semi-rigid hub.
8. The syringe according to claim 6, wherein the groove extends around an entire inner circumference of the inner surface of the semi-rigid hub.
9. The syringe according to claim 6, wherein the elastomeric seal comprises: an outer surface adapted to slidingly engage with the barrel of the syringe; and an inner surface adapted to engage the semi-rigid hub.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) FIG. 1 shows a prior-art injector with a syringe loaded;
(2) FIG. 2a shows various components of the syringe as used in the present invention;
(3) FIG. 2b shows an assembled syringe;
(4) FIG. 2c shows the assembled syringe of FIG. 2b in conjunction with a plunger;
(5) FIG. 3a shows oblique side views of the hub;
(6) FIG. 3b shows a side view of the hub;
(7) FIG. 3c shows a cross sectional view of the assembled hub and seal;
(8) FIG. 3d shows a front view of the hub;
(9) FIG. 3e shows a rear view of the hub;
(10) FIG. 4a shows alternative conformations of the engaging portion of the hub, in the form of grooves;
(11) FIG. 4b shows a cross section of the hub and engaging portion;
(12) FIG. 4c shows a cross section of the hub and engaging portion, having a conventional seal, with an extended leading edge;
(13) FIG. 4d shows a cross section of the hub and engaging portion, having a seal integral to the hub;
(14) FIG. 4e shows a cross section of the hub and engaging portion, having an o-ring seal;
(15) FIG. 4f shows further alternative conformations of the engaging portion of the hub;
(16) FIG. 5 shows example dimensions of the hub;
(17) FIG. 6 shows a cross-section of the plunger engaging the hub;
(18) FIG. 7 shows a cross sectional side view of one possible embodiment of the plunger/hub interlocking arrangement;
(19) FIG. 8 shows a front cross-section along the line A-A of FIG. 7;
(20) FIG. 9 shows an alternative arrangement of FIG. 8;
(21) FIG. 10 shows an alternative example of the plunger/hub interlocking arrangement;
(22) FIG. 11 shows a front cross-section along the line A-A of FIG. 10;
(23) FIG. 12 shows an alternative arrangement of FIG. 11;
(24) FIG. 13 shows an alternative arrangement for the plunger/hub interlocking arrangement;
(25) FIG. 14 shows a front cross-section along the line A-A of FIG. 13;
(26) FIG. 15 shows yet another alternative of the plunger/hub interlocking arrangement;
(27) FIG. 16 shows a front cross-section along the line A-A of FIG. 15 showing the cam in detail;
(28) FIG. 17 shows yet another alternative example of the plunger/hub interlocking arrangement, having a ring actuated hub locking mechanism;
(29) FIG. 18a shows a side view of the syringe holder with catch;
(30) FIG. 18b shows the syringe holder and catch of FIG. 18a with the syringe and hub located in the syringe holder;
(31) FIG. 18c shows a side oblique view of the syringe holder and catch of FIG. 18a;
(32) FIG. 18d shows a side oblique view of the syringe holder, catch and syringe of FIG. 18b;
(33) FIG. 18e shows a side oblique view of a syringe holder, catch and syringe according to the present invention;
(34) FIG. 19 shows a cross section side view of the syringe holder/syringe combination within the sleeve of the injector, with the syringe retained by a catch;
(35) FIG. 20 shows a cross-section along the line A-A of FIG. 19;
(36) FIG. 21 shows a cross-section along the line B-B of FIG. 19;
(37) FIG. 22a shows a cross section side view of the syringe holder/syringe combination within the sleeve of the injector, with the syringe retained by a catch depicting the illumination member;
(38) FIG. 22b shows the arrangement of FIG. 19 with a self-ejecting mechanism;
(39) FIG. 23a shows a plunger adapted to be a syringe hand filler and associated holder;
(40) FIG. 23b shows a syringe and syringe holder comprising a concave syringe front flange and corresponding dovetail catch;
(41) FIG. 23c shows a perspective view of a syringe with a concave front flange;
(42) FIG. 23d shows a cross-sectional view of a syringe with a concave front flange;
(43) FIG. 23e shows a cross-sectional view of a dovetail catch according to the present invention;
(44) FIG. 23f demonstrates in cross-section, various alternative arrangements of catches according to the present invention;
(45) FIG. 24 shows the connection and orientation of certain key elements in the system, as oriented during the filling sequence;
(46) FIG. 25 shows an example of a Barbed Spike for tapping the bung of a medical fluid bottle;
(47) FIG. 26 shows various views of an example of a combination male luer connector and frangible spike;
(48) FIG. 26a is an oblique view of combination Luer connector with frangible spike, locking collar, and tube, before assembly;
(49) FIG. 26b is a longitudinal axial cross-section view of combination Luer connector with frangible spike, and locking collar, after assembly;
(50) FIG. 26c shows a combination Luer connector with frangible spike, locking collar, and tube, after assembly and bonding;
(51) FIG. 26d is a combination Luer connector with frangible spike and locking collar, shown after the spike has been “snapped off” at the frangible neck;
(52) FIG. 27 shows an example of a male Luer Connector with barbed frangible spike, and locking collar, as follows:
(53) FIG. 27a shows a longitudinal axial cross-section view of a Luer Connector with barbed frangible spike, locking collar, and bonded tube;
(54) FIG. 27b shows an example of a Luer Connector with barbed frangible spike and locking collar, after assembly and bonding; and
(55) FIG. 27c shows a shorter example of a Luer Connector with barbed frangible spike, locking collar, and bonded tube;
(56) FIG. 28 shows a combination Luer Connector with frangible spike, permanently bonded to the associated Extension Tube and Syringe to form a non re-usable set for injecting patients;
(57) FIG. 29 illustrates a typical syringe male Luer lock connector;
(58) FIG. 29a shows an outer overall view of the luer lock of FIG. 30;
(59) FIG. 29b Figure shows a longitudinal axial cross-sectional view of a typical syringe luer lock connector;
(60) FIG. 30 illustrates a longitudinal axial cross-sectional view of an ordinary soft plastic tube pushed over the tip of a typical luer;
(61) FIG. 31 demonstrates various views of the basic or Plain form of a clamp according to the present invention;
(62) FIG. 31a demonstrates a side view of the Plain clamp;
(63) FIG. 31b demonstrates an oblique view of the Plain clamp;
(64) FIG. 31c depicts the Plain Clamp in longitudinal axial cross-section;
(65) FIG. 31d depicts a longitudinal axial cross-sectional view of a soft plastic tube pushed over the tip of a luer, and the plain clamp pressed into the female locking thread of a luer locking syringe;
(66) FIG. 32 depicts a clamp with barbed rings;
(67) FIG. 32a depicts an oblique outer view of a clamp having annular barbed rings added to the outer surface;
(68) FIG. 32b depicts a longitudinal axial cross-sectional view of a clamp having annular barbed rings added to the outer surface;
(69) FIG. 32c depicts a longitudinal axial cross-sectional view of a barbed clamp pressed into the female locking thread of a luer locking syringe, and clamping a tube onto the associated male luer tip;
(70) FIG. 33 depicts a clamp with male threads;
(71) FIG. 33a depicts a plain clamp with male threads;
(72) FIG. 33b depicts a plain clamp having male outer threads, with the addition of serrated grip to the rear end of the clamp;
(73) FIG. 33c depicts a longitudinal axial cross-sectional view of a plain clamp having male outer threads added to the outer surface;
(74) FIG. 33d depicts a longitudinal axial cross-sectional view of a clamp having male outer threads, screwed into the female locking thread of a luer locking syringe, and clamping a tube onto the associated male luer tip;
(75) FIG. 33e depicts a longitudinal axial cross-sectional view of a clamp having male outer threads, with the addition of an annular ridge added to the inside surface of the clamp;
(76) FIG. 33f depicts a longitudinal axial cross-sectional view of a clamp having male outer threads plus an annular internal ridge, screwed into the female locking thread of a luer locking syringe, and clamping a tube onto the associated male luer tip;
(77) FIGS. 34 & 35 illustrate flanges added to the rear end of clamps;
(78) FIG. 34a illustrates a side view of a Threaded Clamp with a plain flange added to the rear end of the clamp;
(79) FIG. 34b illustrates a rear view of a Threaded Clamp with a plain flange added to the rear end of the clamp;
(80) FIG. 35a illustrates a side view of a Tamperproof Threaded Clamp having barbed teeth added to the outer perimeter of the flange;
(81) FIG. 35b illustrates a rear view of a Tamperproof Threaded Clamp having barbed teeth added to the outer perimeter of the flange;
(82) FIG. 36 illustrates a side perspective view of a syringe holder with an engagement portion to enable releasable engagement with a medical injector and sensing system to detect the presence of the syringe;
(83) FIG. 37a illustrates an exploded perspective view of a syringe holder with a bayonet attachment, loaded syringe and sensing system to detect the presence of a syringe;
(84) FIG. 37b illustrates a cross-sectional view of the holder and syringe of FIG. 37a;
(85) FIG. 37c illustrates a syringe flag for use with the syringe sensing system;
(86) FIG. 37d illustrates a cross sectional view of the injector nose with holder lock post;
(87) FIG. 38a illustrates a longitudinal cross-sectional view of a syringe holder with a bayonet attachment, loaded syringe and sensing system to detect the presence of a syringe;
(88) FIG. 38b illustrates a lateral cross sectional view of the syringe holder and syringe of FIG. 38a through the line MM;
(89) FIG. 38c illustrates a lateral cross sectional view of the syringe holder and syringe of FIG. 38a through the line LL;
(90) FIG. 38d illustrates a lateral cross sectional view of the syringe holder and syringe of FIG. 38a through the line KK;
(91) FIG. 38e illustrates a syringe flag for use with the syringe sensing system;
(92) FIG. 39a illustrates a cross sectional view of a syringe in a syringe holder demonstrating a particularly preferred embodiment of the engagement mechanism between the hub and plunger during movement of the plunger to expel fluid from the syringe;
(93) FIG. 39b illustrates the syringe and syringe holder of FIG. 39a during movement of the plunger to draw fluid into the syringe;
(94) FIG. 40 illustrates a longitudinal cross sectional view of a plunger and hub demonstrating a preferred embodiment of the sensor to detect engagement between the hub and plunger;
(95) FIG. 41 illustrates an injector with tilt switches in the injecting (down) position; and
(96) FIG. 42 illustrates an injector with tilt switches in the filling (up) position.
DESCRIPTION OF PREFERRED EMBODIMENTS
(97) A typical injector system used for similar applications as the present invention includes an automatic injector device 100. The injector will normally have a data entry pad 110 together with a display 120 for entering data and viewing data respectively. The type of data that may be entered into the system includes injecting rates and volumes. The system according to the prior art includes a pressure jacket or sleeve 140 which is connected to injector 100 for retaining an appropriate syringe 300. Tube 400 connects syringe 300 to the patient (not shown). The prior-art arrangement of the injector as shown in FIG. 1 suffers from a number of disadvantages. Firstly, to install syringe 300 into injector 100, sleeve 140 must first be removed or opened to allow syringe 300 to be rear- or breech-loaded into the sleeve 140 and fixed therein by reattaching or closing sleeve 140. In some cases, sleeve 140 is completely closed, like that shown in FIG. 1, requiring that tube 400 be attached after loading and removed before unloading the syringe 300. This increases the amount of time required to load the syringe, and increases the risks of spillage of contaminated blood. These disadvantages are addressed by the system of the present invention, which allows the syringe 300 to be loaded into the injector 100 directly from the front and does not require sleeve 200 to be removed, loaded and re-inserted into injector 100.
(98) To allow syringe 300 to be inserted easily from the front, the syringe itself may be flangeless. That is, the outer cylindrical surface of the syringe may be free of any interfering projections which normally exist on syringes.
(99) A syringe in accordance with the present invention is shown in FIG. 2a wherein there is shown the barrel of the syringe 300, into which are inserted a hub 310 and corresponding seal 320. Upon assembly of hub 310 and barrel 300, the syringe appears as shown in FIG. 2b. The hub and seal can be manufactured as one component [illustrated in FIG. 4d]. For the preferred embodiment the hub is made from semi-rigid plastic, whilst the seal is made from elastomer. In practice, manufacturers of the syringe could sell the syringe barrel either empty, or pre-filled with the required amount of medical fluid to be injected into the patient, which is retained inside the barrel by the hub and seal combination.
(100) To inject the drug contained within the syringe, a plunger 130, which is operatively connected to the injector 100, engages the inner surface of the hub 310 and it is actuated by the injector 100 in accordance with the required controlled motion. As plunger 130 is driven into syringe barrel 300, this causes hub 310 and seal 320 to be driven relatively towards the other end of barrel 300, thereby injecting the drug through tube 400 into the patient (not shown). The hub according to the present invention may be made of any suitable semi-rigid plastic such as polypropylene or styrene, whilst the seal could be made from an elastomeric substance such as Santoprene, Kraton, Improflex, Kraiburg, etc.
(101) The hub 310 is shown from various angles in FIG. 3. In particular, annular groove 311 is shown on the inside surface of hub 310. The cross-section of the groove may take on any appropriate shape as shown in FIG. 4a including, semi-circular, squared and triangular cross-sections. In addition, FIG. 4c shows a hub assembled with a seal 320 having an extended leading edge on the seal lip to improve sealing under pressure. FIG. 4d shows a hub and seal combined in one piece which provides the benefits of reduced manufacturing costs. Other advantages of this arrangement are also apparent such as (1) increased lubricity if a low friction material such as polypropylene is used, (2) elimination of silicone or other lubricants, (3) reduction of particles in syringe; and (4) reduced/eliminated assembly costs. The purpose of this groove will be described in more detail below. FIG. 4e further depicts a hub having an annular seal 312 seen in cross section.
(102) The dimensions of the hub will obviously be made in accordance with the particular syringe being used. By way of example, it is envisaged that they will typically be of the order of the dimensions shown in FIG. 5.
(103) The tip of injector plunger 130 is formed so as to effectively engage with the inner surface of hub 310 as clearly shown in FIG. 6. Annular groove 311 is also clearly seen as defining a space between the wall of the hub 310 and the surface of the tip of injector plunger 130. This engagement between plunger 130 and hub 310 is such as to provide a form fit so that the force actuated by injector plunger 130 is efficiently imparted to hub 310, causing the hub and associated seal 320 (not shown in FIG. 6) to travel forward along the inner surface of syringe 300, and thereby expel the contents of the syringe.
(104) It is envisaged that injector plunger 130 will be useful for emptying a pre-filled syringe. However, empty new syringes are often filled just prior to use within such injectors, which requires the hub and seal to be retracted by plunger 130. It will be seen that by itself, plunger 130 does not grip or retain hub 310. Therefore another mechanism is required to allow plunger 130 to effectively grip hub 310 and enable it to withdraw the hub and seal from the syringe barrel. Groove 311 provides such a mechanism.
(105) As can be seen in FIG. 7, upon retraction of the plunger, pins 142 protrude from plunger 130 at the location of groove or recess 311. Pins 142, filling groove or recess 311, act as retention members allowing hub 310 to be withdrawn from the syringe barrel 300 as injector plunger 130 is withdrawn. The mechanism by which pins 142 are caused to enter groove or recess 311 may take on many forms as now discussed in further detail in FIGS. 7 to 16.
(106) In one embodiment as shown in FIG. 7, plunger 130 may include actuating rod 140 with a cam element 141 projecting from a nose end of actuating rod 140. Cam element 141 is an oval-shaped rod, which upon insertion of plunger 130 into syringe barrel 300, lies in a horizontal plane. Pins 142 rest against the outer surface of cam element 141 and are biased towards cam element 141 via springs 143. In this position, the outer ends of pins 142 lie within or below the surface of plunger 130. Once the plunger/hub/seal arrangement has reached the end of syringe barrel 300, and is required to be retracted from the barrel, actuating rod 140 may be rotated about its axis, such that cam element 141 now lies in a vertical plane as shown in FIG. 8. As cam element 141 rotates, pins 142, which are biased against the surface of cam element 141, are caused to be pushed out towards the surface of plunger 130 such that their outer ends protrude from plunger 130 and are received in groove or recess 311 as shown in FIG. 7. In this position, hub 310 is retained by plunger 130 and is able to be withdrawn from syringe barrel 300. As discussed above, this mechanism may take on many forms, a further one of which is shown in FIG. 9. In this case, cam element 141 may have a square cross-section which allows the four pins 142 to be extended from plunger 130 to be received in groove or recess 311. The heads of pins 142 are biased against the four sides of cam element 141 and upon rotation of cam element of 141, are caused to be biased against the four corners of cam element 141, resulting in pins 142 protruding from the surface of plunger 130.
(107) In another embodiment of a mechanism for actuating pins 142 shown in FIGS. 10 to 12, cam element 141 is replaced by a cone element 144. In this embodiment, pins 142 are biased against the outer surface of cone element 144 by springs 143 as in the previous embodiment. In use, plunger 130 is inserted into syringe barrel 300 and hub 310, whilst actuating rod 140 is pressed as far as possible against the forward surface 131 of plunger element 130. In this position, pins 142 rest against the narrowest portion of cone element 144 and are biased away from the outer surface of plunger 130 by springs 143. Before or upon retraction of plunger 130, actuating rod 140 is pulled away from surface 131 causing pins 142 to slide along cone element 144 up the cone surface. This causes pins 142 to be pushed out and to protrude from the outer surface of plunger 130 to be received in groove or recess 311. Hub 310 is thereby retained by plunger 130 and able to be moved along the syringe barrel 300. This arrangement also allows for four pins to be used to be received in groove or recess 311 as shown in FIG. 12. The cone arrangement of FIGS. 10-12 may also be used in a “gravity operated” locking mechanism whereby plunger 130 only retains hub 310 when the syringe assumes a particular orientation. Such an arrangement (as shown in FIGS. 13 and 14) is particularly useful when it is desired to prevent re-use of a syringe between patients. This is desirable to reduce the risks of cross-patient infection or contamination.
(108) It will be appreciated that it is advisable to tilt the injector upward during syringe filling in order to ensure that air is kept at the syringe outlet for subsequent removal prior to injection. Additionally, it is advisable to tilt the injector downward during injection (to keep any remaining air in the syringe by the hub so that any air will remain in the tubing between the syringe and the patient after the injection, and therefore not enter the patient.
(109) Generally, new syringes are supplied with the hub and seal arrangement placed in a fully retracted position, i.e., near the back of syringe barrel 300. It is also customary to retract the plunger following each use. In one embodiment, with the injection unit 100 oriented down, the syringe is loaded through the front end of the cylindrical sleeve in the injector unit, which aligns the syringe with the plunger. As a consequence, hub 310 engages plunger 130. It should be noted that if a used syringe had been loaded, the hub would not engage the fully retracted plunger (i.e., because the hub would not be in the fully retracted position within the syringe barrel). To fill the syringe, the injector with the syringe loaded therein is then tilted vertically. As the injector unit is tilted vertically weight rod element 145 drops down within a cylindrical cavity 132 in plunger 130 as shown in FIG. 13. As weight rod element 145 drops, cone element 144 causes pins 142 to be pushed out to protrude from the outer surface of plunger 130 to be received in groove or recess 311 of hub 310. Thus, hub 310 is retained by plunger 130. Upon tilting up, plunger 130 is able (through an automatic tilt switch and controls) to push hub 310 and associated seal 320 (not shown) towards the top end of syringe barrel 300 until the plunger cannot advance any further and seal 320 rests up against the front end of syringe barrel 300, expelling the unwanted air.
(110) Upon actuating the plunger in the reverse direction, hub 310 and seal 320 are retracted and the syringe is able to be filled. To inject the contents of the syringe into the patient, the injector unit is returned to a downward position and plunger 130 is once again advanced along syringe barrel 300, expelling the contents of the syringe. As the injector assembly assumes a downward orientation, weight rod element 145 returns to a forward-most position within cavity 132. This causes pins 142 to be retracted below the outer surface of plunger 130 due to springs 143 and due to the fact that the heads of pins 142 are now allowed to rest against the narrow portion of cone element 144. Upon completion of the injection procedure, plunger 130 is automatically retracted from syringe barrel 300 and, because pin elements 142 have been retracted into plunger 130, hub 310 is no longer retained by the plunger and therefore remains at the front-most portion of syringe barrel 300. Accordingly, the used syringe (whether just used, or later reloaded) cannot be reused because given that hub 310 has been advanced (at least partially) along the syringe barrel 300, the hub will not be engaged with the fully retracted plunger 130, and cannot be retained when the injector is tilted up.
(111) If the injector unit was raised to assume a vertical position again, weight rod element 145 drops down due to gravity, causing pins 142 to extend beyond the top surface of plunger 130. If plunger 130 were advanced into the barrel 300, it will not be able to proceed past the back end of hub 310 due to the protrusion of the pins. This will alert the unit operator that the syringe has been used and prompt them to obtain an unused syringe.
(112) Yet a further possible implementation of the locking mechanism involves the use of cam element 154 connected to an actuating rod 133 which is contained within the body of plunger 130. This arrangement is shown in FIGS. 15 and 16. During the advancement of plunger 130/hub 310/seal 320 combination into the barrel 300 of the syringe, actuating rod 133 is orientated such that cam element 134 is positioned with its nose pointed downwards from the point of view of FIGS. 15 & 16, such that no part of cam element 134 protrudes from plunger 130. Once hub 310 with seal 320 (not shown in FIG. 15 or 16) is then required to be retracted, actuating rod 133 is rotated in the direction of the curved arrows such that the nose of cam element 134 protrudes from the surface of plunger 130 and is received in groove or recess 311. In this manner, hub 310 and connected seal 320 are retained by plunger 130 and may be retracted within the syringe barrel upon retraction of plunger 130.
(113) It will also be appreciated that pin elements 142 (FIGS. 7 to 14) need not be individual pins but may take the form of a unitary ring within plunger 130 which may lie flush with or below the surface of plunger 130 during the advancing stage and which may be caused to expand to protrude from the surface of plunger 130 to be received in groove or recess 311.
(114) Such an arrangement is shown in FIG. 17, in which plunger 130 is divided into two sections—a main body portion 139 and a nose portion 136. Connecting these two portions is an actuating rod 135, a front end of which is embedded in nose portion 136. By pushing actuating rod 135 forward, nose portion 136 is caused to be longitudinally displaced by a small amount, forming gap 137 between main body portion 139 and nose portion 136. The radial ends of gap 137 are chamfered, creating void 138, the size of which is dependent on the size of gap 137. Within void 138, lies an expandable ring 800. This may be a rubber o-ring, a metal circlip, or any other suitable ring element. Ring 800 is biased towards its centre, such that it will tend to lie as deep as possible within void 138, and below the surface of plunger 130. This will be the position assumed when plunger 130 is moving forward along the syringe.
(115) To retract hub 310, actuating rod 135 is moved backwards to cause gap 137 to close, in turn causing void 138 to become smaller. This in turn pushes ring 800 radially outwards, to protrude from plunger 130, and to be received in groove or recess 311, thereby retaining hub 310 to plunger 130.
(116) It will be understood that groove or recess 311 need not in fact encompass the full circumference of the inner surface of hub 310, but may take the form of individual recesses or depressions within the surface of hub 310 to receive individual pins from plunger 130. It will be understood that if rod 135 were the driving member of the injector, and plunger body 139 were restrained by a friction ring system such as that described in FIGS. 39a and 39b, the hub retention function described above will operate automatically.
(117) The loading and retention of syringe barrel 300 inside injector unit 100 will now be described with reference to FIGS. 18a-e to 21. FIGS. 18a to 18d show various views of a syringe cradle member in the embodiment wherein the cradle member is a sleeve 200 and associated catch 500. FIG. 18e depicts the embodiment wherein the cradle member is a cradle 205 containing syringe barrel 300.
(118) The left-most (rear) end of sleeve 200 (from the view of the depictions) is inserted into a receiving opening in the injection unit, while syringe barrel 300 is slipped rear first into sleeve 200 via the oblique opening appearing on the right hand side of sleeve 200 as seen from the figures. FIGS. 18b and d show various views of the embodiment wherein the cradle member is a sleeve 200 containing syringe barrel 300. Also visible are hub 310 and connected seal 320 which are positioned at the base end of syringe 300 as described previously. Catch 500 is pivotally connected to sleeve 200 as can be seen in FIGS. 19, 20 and 21. Syringe holder 200 is engaged in nose 10 of the injector (not shown). The connection between catch 500 and holder 200 is via catch hinges 510. Spring 540 biases one end of catch 500 away from the body of sleeve 200 such that syringe catch 520 is biased upwards and through sleeve aperture 530 as seen in FIG. 19. Upon insertion of syringe barrel 300 into sleeve 200, syringe catch 520 is displaced downwards by a downward force caused by the syringe sliding across the sloped top surface of syringe catch 520 (actuated by a human operator). Once syringe barrel 300 has been fully inserted into sleeve 200 (determined by syringe stop ring 210), spring catch 520 snaps back to assume its steady state position to engage a front portion 330 of syringe barrel 300, thereby retaining it within sleeve 200. This retention is strong enough to withstand the pressure experienced by the syringe upon actuation of the injector forcing plunger 130 into the barrel 300 to expel the contents of the syringe. In fact, the upright front edge 521 of catch 520 is angled so that it lies parallel to the front edge of sleeve aperture 530, which is itself similarly angled. This angle is chosen carefully to be greater than 90 degrees to the moment of force exerted by flange 330 on forward edge of aperture 530. In this way, the engagement forms a wedge or “dove-tail”, which prevents catch 520 from being released when the syringe is forced forward by the plunger, thereby providing a highly secure retention means.
(119) Furthermore, syringe sleeve 200 is close-fitting to the inserted syringe barrel 300. This helps to support the syringe against expansion under the high pressures caused in injectors, thereby enabling a thinner walled, lower cost syringe. Sleeve 200 is also preferably transparent, to allow an unobstructed view of the contents of the syringe (e.g., to determine if air is present in the syringe), which itself is transparent.
(120) As discussed previously, this arrangement allows the syringe to be loaded into the injector unit in a single action by simply sliding it into a receiving sleeve from the front and without having to remove any part of the injecting unit. Further, the syringe and the hub need not be oriented in a particular manner. This saves a great deal of time and effort in syringe assembly and everyday use of the injector, and results in a simpler construction of the injector.
(121) FIG. 22a demonstrates another preferred embodiment whereby there is an illumination member in the form of Light emitting diodes (LEDs) 4200 which are placed at the exposed rear (left-most) end of syringe sleeve 200 so that some of the light is received and transmitted along the walls of the sleeve. As with any thin, dense, transparent material, most of the received light is internally reflected longitudinally, as well as laterally, producing a diffused glow at the front end of the sleeve as depicted by arrows 4250. The beveled front end of the sleeve 4255 is preferably frosted (e.g., sanded) to achieve maximum diffusion, and is visible form a wide angle. Any suitable light source may be used, but they are preferably focused or reflected so that most of their output is projected towards the sleeve. Thus, in the embodiment depicted, they are LEDs.
(122) The illumination sources may be various colours, and/or pulsed to provide many attractive effects, and may be used to remind the operator, for example, to remove the syringe.
(123) It should be noted that the patient's blood may sometimes find its way into tube 400 and syringe 300 by virtue of the fact that, on occasion, while connected to the patient, the hub is retracted to draw blood back through tube 400 and into the syringe, for example to verify that the needle has properly entered the patient's vein. Since the syringe can be loaded from the front, tube 400 (as depicted in the FIG. 1 in relation to the prior art), may be permanently fixed to the syringe, and need not be connected and disconnected after use. This reduces the risk of spilling contaminated blood.
(124) To further increase the efficiency of the system, syringe stop ring 210 may consist of 2 parts, separated by a spring element 220, as shown in FIG. 22b. The first part is a fixed part 210a which is essentially a portion of stop ring 210 in FIG. 18 and is fixed to syringe sleeve 200. The second part is a sliding ring 210b, which is able to slide over the inner surface of sleeve 200. Coil Spring element 220 biases sliding ring 210b away from fixed ring 210a and towards the front end of sleeve 200. When the syringe 300 is loaded into sleeve 200, its rear rim will engage slide ring 210b and force it towards fixed ring 210a, compressing spring element 220 there between, until spring catch 520 snaps back to retain syringe 300 as described above. In this state, syringe 300 is biased against catch 520 by the force of spring element 220 acting on sliding ring 210b. Accordingly, when syringe catch 520 is disengaged from syringe 300 (by pushing on syringe catch release button 550), syringe 300 is automatically partially ejected from sleeve 200 to facilitate removal thereof from the injector.
(125) Some injector users prefer to manually fill syringes without the use of an injector. This ability is also of great benefit when users wish to pre-fill syringes, particularly when the injector is in constant use.
(126) On the occasions where a syringe is desired to be manually filled, the present invention also provides for easy filling of the syringe. This is accomplished by way of a hand filler 700 as shown in FIG. 23a. This device is effectively a hand-held version of the plunger 130 described in detail above, and works in a similar manner. In use, the hub 310 and seal 320 could be located anywhere along the syringe. To fill the syringe, the hub/seal must be drawn back towards the rear of the syringe. To do this, hand plunger 700 is introduced into the syringe barrel 300, and pushed into the hollow of hub 310. In this position, pins 750 within the head of the hand filler do not protrude beyond the surface of the hand plunger 700. This is because cone element 730, inside the hand filler, is biased forward by spring elements 740, causing pins 750 to rest against the narrowest portion of cone element 730. Upon retraction by hand (with the fingers 610 of the operator engaging the handle 710 of the plunger), cone element 730 is pulled back with the head of hand plunger 700, forcing pins 750 outwards to be received in groove or recess 311, thereby engaging hub 310 and seal 320. Thus engaged, the hub and seal are drawn back through syringe 300 with the hand plunger 700, at the same time drawing in liquid through hole 340 and filling the syringe. When the hub 310 and seal 320 have reached the back of the syringe, hand plunger 700 is disengaged from hub 310 by reducing backward force on the plunger, allowing cone element 730 to move forward under the force of spring element 740, and allowing pins 750 to withdraw from recess or groove 311 as previously described. The filled syringe is then ready to be loaded into the injector 100 as described above. It should be noted that no part of the device can, at any stage touch the inner bore of the syringe, which could contaminate the sterility of the syringe. It should also be noted that the mechanism retaining the hub to the plunger can take many forms, including those described in FIGS. 7 to 17.
(127) In another embodiment, the filled syringe may be left connected with the hand filler, and the combination may be connected at the neck 735 to the front end of a suitably modified injector. In this application, the hand filler becomes a syringe holder and pressure sleeve. The complete hand filler device is used to firstly fill the syringe, then the filler device (with syringe) is placed into the injector. The injector pushes on the rear end 710 to expel fluid from the syringe.
(128) Where the hand filler device illustrated is provided only for filling (in association with an injector made for injecting the syringe), then as long as all syringes are fully expelled (as is the convention), then if the length of the plunger 700 were shortened by only a few millimeters, it could not fill a used (fully expelled) syringe because it can not reach the hub.
(129) In a further embodiment, the contents of syringe 300 can be expelled by hand force on plunger knob 710 (i.e., an injector syringe such as 300 could be used as a more conventional hand-held syringe).
(130) As with most injector syringes, syringes as used in the present invention are preferably supplied with the hub/seal in the fully retracted position.
(131) The various mechanisms for retaining the hub to the plunger of the present invention are preferably arranged such that they can be actuated whilst the plunger is in the fully retracted position, and thereby preferably engage, retain, and fill a new syringe. However, the invention contemplates that the plunger can be arranged to engage the hub at any suitable location within the syringe.
(132) Following use, the hub and seal of a used (or partially used) syringe will typically be left somewhere forward of the fully retracted position, and hence the devices of the present invention usually do not engage, retain, fill or operate a used syringe, thereby eliminating, or drastically reducing, instances of cross-patient contamination. However, the invention broadly contemplates arrangements wherein the hub can be left at any position within the syringe.
(133) It will readily be appreciated that there are a number of possible designs for the catch for retaining the syringe within the cradle member/sleeve. FIGS. 23b to 23e illustrate a syringe 300 and syringe holder 200, catch 500 and catch member 520. The inner edge 526 of the catch 520 is of complementary shape to a concave front flange on the syringe 300. FIG. 23f shows three embodiments of the interface between the inner edge of the catch 520 and the front of the syringe 300.
(134) The preferred embodiment of an additional embodiment of the invention comprises the essential elements illustrated and oriented as shown in FIG. 24. An extension tube 1010 is firstly fitted to the tip 1012 of an injector syringe 1014. The syringe 1014 is then fitted to an injector (or syringe pump) 1016. The system operator (not shown) then programs the desired patient injection volume on the injector control panel (not shown), and then the operator tilts the combined injector 16 and syringe 1014 unit upwards as illustrated in FIG. 24, at which point a position or angle sensing tilt switch in the injector preferably causes the piston 1032 of the syringe 1014 to advance automatically by the injector to the desired volume. It will be appreciated by those familiar with the art that such programming and automatic control of the injector is quite known, although not in response to the tilting operation, or means of triggering. Of course, the operator could also initiate some or all of these actions. As the combined injector 1016 and syringe 1014 unit is tilted upwards, any subsequent fluid 1028 from bottle 1026 will fall to the bottom of syringe 1014, and air 1030 in the syringe 1014 will rise to the syringe tip 1012, and be expelled through tube 1010 when the piston is advanced. The free end of tube 1010 is then connected to the socket end 1018 of a special non-vented spike 1020 which is shown in FIG. 24, and in more detail in FIG. 25. The sharp end 1022 of spike 1020 is then driven into the soft rubber bung 1024 of the fluid bottle 1026. The sharp tip 1022 of spike 1020 pierces the bung 1024 of the bottle 1026, creating a path from the bottle contents 1028 through the spike 1020 and tube 1010 to the syringe. It should be noted that at this point the system is sealed from outside air, and pressure in the system will be neutral. It should also be noted that spike 1020 has a barbed neck 1021 as shown in FIG. 25 to ensure it will not be forced out of the bung 1024 when the system is later pressurised. The bottle 1026 is then mounted or hung inverted (as illustrated in FIG. 24) so that fluid 1028 can be drawn out through the spike 1020 and tube 1010 etc.
(135) The “FILL” button (not shown) is now selected on the injector 1016 by the operator, and preferably performs the following sequence automatically:
(136) The syringe piston 1032 is driven fully forward to the tip 1012 of the syringe 1014, compressing the air 1030 in the syringe, tube, and bottle. Much of the sterile air 1030 in the syringe and tube 1010 will be driven into the bottle 1026, and rise to the air space 1034 in bottle 1026. It will be appreciated by those familiar with the art that such air 1030 will be sterile as long as the syringe 1012 was manufactured and sterilised with the hub 1032 fully retracted (i.e., filled with air) as illustrated in FIG. 2b. Without delay, the piston 1032 is then automatically retracted to slightly over (e.g., 130%) the programmed volume, and fluid 1028 is transferred quickly from the bottle 1026 via spike 1020 and tube 1010 into the syringe 1014, aided by both air pressure 1034 in the bottle 1026, plus a partial vacuum in the syringe due to retraction of piston 1032. Following a short delay to allow the pressure to equalise and fluid to fully transfer, the syringe 1014 is filled to more than the programmed fluid volume, plus some residual air. The piston 1014 is then immediately and automatically advanced back to the desired programmed volume, purging any residual air and surplus fluid back to the bottle 1026, leaving the syringe 1014 entirely filled with the programmed volume of fluid, with no air in either the syringe 1014, or tube 1010.
(137) At this stage the “FILL” sequence is complete, and it is important to note that the system has neutral pressure (because the piston has been returned back to the position at which the system was sealed) so that when the tube is disconnected from the bottle (or the spike is removed), the system neither sucks air, nor drips fluid.
(138) The bottle 1026 is now righted, and the tube 1010 is disconnected or detached from the spike connector 1018, and may now be connected to the patient, ready for injection.
(139) It will be appreciated by those familiar with the art that the following facts and arrangements are normal procedure in this field, and may not be well illustrated or described in this document, however are important to the implementation and operation of the invention: Components used in the fluid path, and air contained within each is sterilised during manufacture. There is usually a small void of air or gas in bottles of medical fluid. Before tapping, the protective cap over the bung centre is removed (to allow access to for the spike), however the bung retainer 1025 (shown in FIG. 24) is left on the bottle (otherwise the bung may be dislodged by air pressure during filling). Injector syringes are typically supplied fitted with the plunger retracted (i.e. it is filled with sterile air). The syringe, tube, and spike would have standard luer locking connectors to ensure they are secure and sealed under pressure.
(140) The following variations to the system could enhance the invention under some circumstances: The Fill sequence program could be extended with an additional forward-retract cycle—particularly for volumes approaching the maximum capacity of the syringe. This is to ensure that all air has been expelled. When a syringe is to be filled to near capacity (>75%) there is insufficient travel on the piston to retract 130%. Hence additional strokes are required to expel all the air. This “130%” figure is a function of the volume of (air) the tube, and air space in the bottle—a greater tube volume (or less air space in the bottle) requires more over travel. During the fill sequence, the first compression stroke of the piston would preferably expel all the air from the syringe—particularly for x-ray contrast, where the bottles normally have a significant air space. Alternatively, to optimise performance even with bottles having relatively small air space, during the compression the injector could sense the pressure in the system (for example by sensing the load on the drive means) and retract prematurely if the pressure approached unsafe levels. The controlling electronics and associated displays and audible enunciators could prompt the operator as to what step or otherwise to take next in the filling routine. The injector tilt switches (or sensors) could be used to trigger or inhibit other functions of the injector, for example inhibit injection until the injector and syringe are oriented downward, or enable higher flow rates during fill (rates that would be unsafe for injecting into patients). The syringe 1014 could be supplied with the extension tube 1010 and spike 1014 already assembled (as shown in FIG. 24) during manufacture, further reducing operator time. The Syringe 1014 and Tube 1010 could be manufactured with the tube 1010 permanently attached and bonded directly to the syringe tip 1012, protecting the sterility of the syringe tip 1012, and reducing manufacturing & material costs by dispensing with connector 1013, which is normally used to adapt the tubing 1010 to the syringe tip 1012 (as illustrated in FIGS. 31 to 33, and described below). As well, safety is improved by ensuring the tube cannot be disconnected, possibly releasing contaminated fluids. An air detector (optical, ultrasonic, etc) could be fitted to the tubing, ensuring there is no air present after filling, and disallowing operation of the injector until the air is removed. The syringe 1014 and associated extension tube 1010 could be permanently bonded 1039 to a special combination patient connector with frangible spike (as shown in FIG. 27c), and all supplied as one set 1060. This set could provide a reduced cost, as well as a non-reusable system which could prevent patient to patient cross-infection. This concept is described in detail as follows:
(141) The complete set 1060 (as shown in FIG. 28) is used to fill the syringe much as described previously, however after filling is complete, instead of disconnecting the spike from the tube, spike 60 is then snapped off, and as before, leaves a male luer connector on the end of the tube for connection to the patient. Importantly however, with the spike removed the syringe is less likely to be inadvertently re-filled, and hence cannot be used with more than one patient, thus preventing cross-infection from one patient to the next.
(142) It is understood that a conventional spike can still be attached after the frangible spike is removed and therefore used to re-fill, and possibly cause contamination. This could be overcome by adopting a non-standard connector (e.g., larger diameter Luer). This would require a non-standard mating connector on the needle. Also, if the contents of a bottle are used to fill more than one syringe (as is often the case) the bottle cannot be inadvertently contaminated by re-filling a used syringe.
(143) FIGS. 26 and 27 show various examples 1040 and 1050 of combination male luer connector with frangible spikes and tube 1010. FIG. 28 shows the complete set 1060 having an extension tube 1010 bonded at each end to the syringe 1014 and frangible connector/spike 1050.
(144) The alternative combination connector/spikes are illustrated and described as follows:
(145) FIGS. 26a to 26d show various views of an example of a combination 1040 of male Luer connector 1046 with frangible spike 1042, and locking collar 1047. FIG. 26a is an oblique view of combination Luer connector 1046 with frangible spike 1042 and locking collar 1047 before assembly. Disc 1043 simply provides a grip for holding the spike. The frangible neck 1044 is seen clearly in FIG. 26b, which is a longitudinal axial cross-section view of a combination Luer connector 46 with frangible spike 1042 and locking collar 1047, after assembly. The locking collar has a conventional female luer locking thread for retaining the patient needle, which is connected after the spike is detached. Small raised nodules or barbs 1048 serve as detents to discourage the collar from sliding off the connector once assembled. The locking collar 1047 is not essential to the invention, however is advisable when used with pressure injectors.
(146) FIG. 26c shows a side view of the combination connector/spike/collar 1040, after assembly and bonding to the tube 1010.
(147) FIG. 26d shows a combination connector/spike/collar 1040 after the spike has been detached at the frangible neck 1044, leaving a standard male luer lock connector 1046 on the end of the tube 1010.
(148) FIGS. 27a to 27c show various views of an alternate example of a combination 1050 of male Luer connector 1046 with barbed frangible spike 1051, and locking collar 1047. The barbs 1053 are useful in discouraging the spike from being dislodged from the bung 1025 of the bottle 1026 during the pressurization phase of filling.
(149) FIG. 27a shows a longitudinal axial cross-section view of combination 1050 connector/barbed frangible spike/collar.
(150) FIG. 27b shows combination 1050 connector/barbed frangible spike/collar, after assembly and bonding to the tube 1010.
(151) FIG. 27c shows a shorter example of combination 1050 connector/barbed frangible spike/collar. It will be appreciated by those familiar with the art that the spike may well be significantly shorter (in proportion) depending on the size of the bottle and bung.
(152) FIG. 28 shows an example of combination 1060 connector/barbed frangible spike/collar permanently bonded to the associated Extension Tube 1010 and Syringe 1014, to form a non re-usable set 1060 for injecting patients.
(153) The complete set 1060 is used as follows: Firstly the spike 1051 is inserted into the bung (not shown in FIG. 28), and the syringe 1014 is filled as previously described. After the spike 1051 is withdrawn from the bung, the spike end 1051 is “snapped off” at the frangible neck 1044 and discarded, leaving the conventional male luer lock tip 1046 for connection to the patient (not shown). It should be noted that the patient (not shown) cannot possibly be connected to the set 1041 until the spike 1051 is detached. Once separated however, the spike 1051 cannot ordinarily be reconnected, and hence associated tube 1010 and syringe 1014 cannot be re-filled, thus ensuring only one patient can be injected per set—i.e., this prevents any chance of inadvertent cross infection from one patient to the next.
(154) It would be appreciated by those familiar with the art that a vented spike could also be combined frangibly with a male luer connector, however the syringe would be filled in a more conventional manner.
(155) It should be noted that all cross-section views in FIGS. 29 to 33 are longitudinal, through the axis of the parts.
(156) As required above and elsewhere in medicine, it is often desirable to connect or bond a flexible plastic tube directly to a rigid plastic spout or luer outlet. A typical male Luer Lock connection is illustrated in FIG. 29, before connection. FIG. 29a shows an overall view, and FIG. 29b shows a longitudinal axial cross-section view. The syringe body 2010 has an outlet connector tip 2011 which has a tapered male luer outer surface 2014, surrounded by a female locking thread 2012 of larger diameter, on the same axis but slightly forward of the thread. It should be noted that almost all luer tapers 2014 are made to a standard diameter, with a taper of approximately 6% as defined in International Standard ISO594. The outer luer taper 2014 is clearly evident in cross-section FIG. 29b. Syringes 2010 (including tip 2011 and thread 2012) are normally injection moulded from tough semi-rigid transparent polypropylene.
(157) FIG. 30 illustrates a soft plastic tube 2016 pushed fully over the syringe tip 2011. The tip 2011 has a tapered outer 2014, and the tubing 2016 stretches and conforms to the taper 2014, and the resultant outer surface 2018 of the tubing forms an enlarged taper.
(158) In FIG. 31 the basic form of clamp invention is shown before and after fitting.
(159) The clamp 2020 is formed in a cylindrical shape with a hollow inner tapered diameter 2021 from semi rigid plastic, with a small chamfer 2022 on the leading edge to assist assembly. The clamp 2020 is installed by simply pushing over the tapered outer surface 2018 of the tube, and inside the female thread 2012 of the syringe connection. It will be understood by those familiar with the art that the clamp 2020 has suitably precise dimensions for a firm interference fit on both its inner and outer diameters, as illustrated, to suit the wall thickness and compliance of both the tubing and the syringe.
(160) When force fitted, the inner taper 2021 of clamp 2020 firmly squeezes the tubing 2016 onto the tip 2011 of the syringe 2010, as shown in FIG. 31. The syringe tip 2011 is also made from semi-rigid plastic, and all components deform slightly to exert even pressure on the luer tip/tube connection, ensuring it is sealed very effectively.
(161) Alternate variations to the basic clamp design are illustrated in FIGS. 32 to 35.
(162) In FIG. 32 small barbed annular rings 2032 have been added to the outer surface of the barbed clamp 2030 to improve retention inside the female locking thread of the connector. The clamp 2030 is pressed over the tube 2016 and into the syringe 2010 as above, and the barbs 2032 interfere with and grip the female thread 2012 ensuring it cannot be dislodged. As above, inner taper 2021 of clamp 2030 firmly squeezes the tubing 2016 onto the tip 2011 of the syringe 2010. This type of clamp would suit permanent and tamperproof applications because the clamp would be almost impossible to remove without the use of tools.
(163) In FIG. 33, male threads 2042 have been added to the outer surface of two similar styles of clamp 2040 and 2050, which mate with the female thread 2012 of the syringe 2010, and have a tapered inner surface 2021. The purpose of thread 2042 is to assist assembly, as well as firmly clamp the tube 2016 onto luer taper 2014. During assembly the clamps 2040 or 2050 are simultaneously pushed and screwed inside the syringe thread 2012 and over the tube 2016, squeezing the tube 2016 onto the luer taper 2014, resulting in a more secure, tighter fitting connection than those described above. As above, inner taper 2021 of clamps 2040 and 2050 firmly squeezes the tubing 2016 onto the tip 2011 of the syringe 2010.
(164) FIG. 33b has additional barbed serrations 2054 to the rear end of the clamp, which assist in gripping and twisting the clamp during assembly.
(165) It will be understood by those familiar with the art that the rear end or flange may take many forms to suit hand, machine, or tooled assembly, and/or to discourage disassembly.
(166) FIG. 33c shows a longitudinal cross-section of either clamp 2040 or 2050, showing male threads 2042, and internal taper 2021 to mate with outer taper 2018 of tube 2016.
(167) FIG. 33d shows a longitudinal cross-section of either clamp 2040 or 2050.
(168) FIG. 33e shows a longitudinal cross-section of clamp 2060, showing male threads 2042, plus an internal annular ridge 2062 added to the inside surface of the ridged clamp 2060.
(169) FIG. 33f shows clamp 2060 after being simultaneously pushed and screwed inside the syringe thread 2012 and over the tube 2016, squeezing the tube 2016 onto the luer taper 2014. The internal ridge 2062 of clamp 2060 concentrates the squeezing action to a short area 2064 [not seen in FIG. 33f] of the union with the tube 2016, providing a more concentrated pressure and improved sealing compared with those described above. Alternately, it could be argued by those familiar with the art that clamp 2060 provides an equivalent seal to those above, with less assembly (and disassembly) force.
(170) It will be understood by those familiar with the art that one or more annular rings may be included on the inner surface of any of the above clamp styles, and that the profile of the ridge may be varied to suit the hardness of the particular tubing employed (not illustrated).
(171) FIGS. 34 and 35 illustrate various flanges 2072 and 2082 (respectively) added to the rear end of the threaded clamp style 2040 previously shown in FIG. 33a. Both clamps 2070 and 2080 have male threads 2042 on their outer surface to mate with syringe female thread 2012, for the purpose of assisting assembly and firmly clamping the tube 2016. FIG. 35 has additional barbed teeth 2082 on the outer perimeter of the flange 2083 which assist clockwise tightening 2084 of the clamp 2080, but hinder anti-clockwise unscrewing, thereby making the connection virtually tamperproof. Both clamps 2070 and 2080 are inserted into the syringe (and clamp the tube) in the same manner as those described above, and may or may not have annular rings on their inner surface.
(172) If a removable clamp is required, clamp 2070 in FIG. 34 would be preferred. Alternatively the flange of clamp 2070 could have non-directional serrations added to assist grip in either direction (not illustrated).
(173) Alternatively, a clamp of style 2080 in FIG. 35b, but having barbs oriented opposite to those on clamp 2080 would ensure the clamp is not over-tightened, as well as improve the likelihood that the clamp could always be removed (not illustrated).
(174) FIG. 36 illustrates a side perspective view of a syringe holder with an engagement portion to enable releasable engagement with a medical injector and sensing system to detect the presence of the syringe. Syringe holder 200 is engaged in injector nose 10 of the medical injector (not shown). Bayonet posts 3010 and a blocking member (holder lock post 3015) on injector nose 10 form part of the engagement mechanism between syringe holder 200 and the injector. Syringe 300 is loaded into holder 200 and retained by catch 500. The injector nose 10 has a sensor or switch 3110 for sensing the presence of a syringe in holder 200. According to the embodiment illustrated, it is an optical sensor.
(175) Holder lock post 3015 is adjacent to syringe sensor 3110 and therefore syringe holder 200 cannot be removed whilst a syringe is installed, nor during an injection. Additionally, a syringe cannot be installed unless holder 200 is locked fully (in this case clockwise). This embodiment is particularly useful in the absence of a sensor to verify syringe presence. It will be appreciated that holder 200 could not be attached if a syringe were already installed.
(176) To engage syringe holder 200 with injector nose 10, the holder is first inserted into the nose and with gentle inwards pressure, rotated until grooves 3020 (as shown in FIG. 37a) engage bayonet posts 3010. At this point holder 200 fully enters the nose 10, and the holder is rotated to lock it in place. Whilst 3 bayonet groove/post sets are illustrated spaced evenly around the circumference, they could also be oriented at matching odd angles so that the holder can only engage in a particular orientation. Seal 3145 could be a simple O-ring or wiper ring, and has 2 important roles: (a) prevent fluids from entering the injector (b) provide a friction means to decrease the possibility of inadvertent removal of the holder.
(177) FIGS. 37a-d and 38a-e illustrate several views of a syringe holder with a bayonet attachment 3010, a blocking member (holder lock post 3015), loaded syringe and sensing system to detect the presence of a syringe. Injector nose 10 is fitted with a fluid seal 3145, a spring stop ring 3140 against which syringe flag spring 3130 abuts. A syringe stop and plunger bush 3135 sits within injector nose 10 and syringe 300 briefly engages bush 3135 to limit movement of the syringe 300 towards the medical injector. Bush 3135 has at least one groove 3150 in which tabs 3122 (as depicted in FIG. 37c), are slidingly engaged. Spring 3130 is compressed during assembly between stop ring 3140 and Tabs 3122 on Flag 3120, thereby biasing Flag 3120 forward (to the right). With no syringe installed Tabs 3122 rest against Bush 3135, and the pointed tip of Flag 3120 protrudes to the right of bush 3135.
(178) Syringe holder 200 with grooves 3020 are introduced into injector nose 10 and the groove is engaged with pins 3010 and rotated to thereby lock it in place. When syringe barrel 300 is inserted into holder 200, it depresses syringe flag 3120 and thus pushes tabs 3122 of the flag against spring 3130. Biased catch 500 snaps shut and locks syringe 300 in place within the holder.
(179) Holder lock post 3015 is of similar width to, and mounted on the same axis, as flag 3120. As holder 200 is attached, flag 200 almost touches it (the lock post?) when bayonet slots 3020 are fully engaged with posts 3010 (without rotating). In the mounted position, with a syringe installed and flag 3020 pushed back, holder 200 cannot be rotated the wrong way (in the present case anti-clockwise) because the flag 200 will engage the lock post 3015 and thereby prevent rotation of the holder 200 within the injector nose 10.
(180) Flag 3120 has a beveled tip 3124 to engage syringe 300 and thereby grip it to minimize rotational movement. The movement of flag 3120 towards the injector triggers sensor 3110 which thereby creates a signal to the effect that a syringe is present in the holder.
(181) In the present case, sensor 3110 is a combination light emitter and detector sensing light reflected off the metallic surface of Flag 3120. The signal created may go to a controller which thereby integrates the information and controls the movement of the syringe plunger 130. For example, the controller may restrict movement of the plunger until after the sensor creates a signal that a syringe is present. When syringe 300 is removed from holder 200, spring 3130 pushes flag 3120 away from sensor 3110 and thereby eliminates the reflections.
(182) During assembly of holder 200 onto injector nose 10, bush 3135 and spring stop 3140 are normally fixed in place inside the holder by means of cement, screws, or pins. Both stops have a small longitudinal groove 3150 in their outer surfaces to support slidable syringe flag 3120 which, together with flag spring 3130, are held in place by bush 3135 and stop 3140. Spring 3130 is lodged between spring stop 3140 and tabs 3122, thereby biasing the flag forward. With no syringe loaded, flag 3120 protrudes forward of the syringe stop 3135, and its tabs lodge against the rear of the syringe stop. A secondary function of the syringe stop is to bear and centre the plunger, and prevent stray fluid around the syringe from entering the injector.
(183) In brief, the Syringe Flag device has 3 main functions: 1. Syringe ejector: Flag 3120 is slidably mounted in groove 3150, and is biased forward by flag spring 3130. As syringe 300 is loaded into holder 200 the rear rim strikes the flag, pushing it rearward and compressing the spring until the tip of the flag is flush with bush 3135. When catch 500 is opened, syringe 300 is partially ejected forward by the flag, making the syringe easier to grasp and remove. 2. When a tube is attached to the syringe (after it has been loaded), the operator needs to twist the connection to engage and lock the connection to the syringe thread. To restrain the syringe from rotating it would ordinarily need to be held with the other hand. However flag 3120 can perform this role. The forward tip 3124 of flag 3120 is beveled & sharp like a chisel, digging into the syringe a little, thereby restraining rotation of the syringe. 3. The flag assists detection of the presence of a syringe in holder 200. Reflective infrared sensors such as Sharp GP2L24 are readily available types of sensors 3110. As the flag is pushed back by the syringe the reflective rear end of the flag is detected by the sensor, which in turn signals the controller. Those familiar with the art will appreciate that various other forms of detection or mechanical switching could be used to sense movement of the Flag 3120.
(184) FIGS. 39a & b illustrate cross sectional views of a syringe in a syringe holder demonstrating a particularly preferred embodiment of the engagement mechanism between the hub and plunger.
(185) Plunger 3600 is slidingly engaged with actuation member 3610 but with a limited free play between them due to space 3625. Note also that free sliding of plunger 3600 is somewhat subdued by the seal 3146. Whenever drive member 3500 and actuation member 3610 reverse direction, plunger 3600 does not move until space 3625 is traversed. Actuation member 3610 and its associated cone 3650 operate pins 3640 to automatically engage or disengage hub 310 at the appropriate time.
(186) Holder 200 is engaged in injector nose 10. Syringe 300 has been fitted into holder 200. FIG. 39a demonstrates this embodiment in the situation where the plunger is expelling fluid from the syringe. Shoulder 3520 of plunger drive 3500 engages and pushes plunger 3600 and actuation member 3610 which is disposed within a bore in plunger 3600. Actuation member 3610 has a rod portion 3165 [not seen; labeled in FIG. 39] and a nose portion 3650 which is cone shaped. The forward movement of nose portion 3650 allows locking members in the form of pins 3640 which are biased by spring 3660 to retract from engagement with the engagement portion of hub 310. Thus hub 310 is automatically unlocked during and following forward movement of plunger 130. The purpose of unlocking the hub is to allow removal of the used syringe following an injection.
(187) On retraction of plunger drive 3500, shoulder 3520 of plunger drive 3500 withdraws from the rear edge of plunger 3600 and thereby actuation member 3610 is drawn away from hub 310. Plunger 3600 is momentarily stationary, causing nose portion 3650 to slide along pins 3640 and thereby force them to extend from plunger 3600 and engage the engaging portion of the hub 310. Shoulder 3630 on actuation member 3610 traverses space 3625 and engages shoulder 3620 in the bore and enables nose portion 3650 to be positioned alongside pins 3640 by stopping actuation member 3610 from moving relatively further away from them. Thus hub 310 is automatically retained during and following retraction movement of plunger drive 3500, enabling retraction of the hub, and filling of the syringe.
(188) Hence this system automatically ensures that the hub is either locked or unlocked at the appropriate time, avoiding inconvenience and enhancing safety of the injector—for the operator and the patient. Of course, the Controller must be programmed to allow for the inherent free play whenever the plunger reverses direction.
(189) FIG. 40 illustrates a longitudinal cross sectional view of a plunger and hub demonstrating a preferred embodiment of the sensor to detect engagement between the hub and plunger. Syringe 300 has a hub 310 slidingly disposed within it. Sensor 3300 is a light sensor with an optical fibre cable 3350 which is partially embedded in plunger 130. Optical fibre 3350 has an exposed end 3355 which is flush with the surface of plunger 130 and detects incident light 3360 which passes through transparent syringe 300. Incident light is then transmitted 3365 along optical cable 3350. When plunger 130 has fully engaged hub 310, which is opaque, incident light will not be able to hit the end of optical cable 3350. Therefore, the light sensor 3360 will detect the absence of light and create an appropriate signal. Of course, if the room lights are inadequate for the sensor to operate, the Plunger can be illuminated by the injector with visible or infrared light.
(190) This signal may be sent to a controller via cable 3370 to enable further control over the movement of plunger 130. For example, it may allow plunger 130 to automatically stop upon full engagement with hub 310 without thereby causing hub 310 to be moved forward. According to this embodiment, since the aperture at the end of the optic fibre is small, then the ambient light is cut off abruptly as the plunger enters the hub, and so the accuracy and predictability of the system is enhanced. Similarly, because of the high contrast between the engaged and non-engaged states, the level of ambient or illuminated light is not critical.
(191) FIGS. 41 & 42 illustrate one embodiment of the medical injector with tilt switches in the injecting and filling positions. Injector Head 4000 contains the control and drive elements of the Injector and is mounted at Head Pivot 4050 to Injector Pedestal 4100, which preferably stands on a wheeled base (not shown). Head 4000 is able to tilt about the pivot by at least 90 degrees.
(192) A small Switch Tab 4030 extends from Injector Pedestal 4030. Switches 4010 and 4020 are fixed to the head in such positions as to strike the Switch Tab at the opposing positions of DOWN (4020) and UP (4010), at which points the appropriate switch changes state, and communicates to the Control circuitry (not shown) the orientation of head 4000. These communications can be used to initiate or inhibit a plurality of functions, operations, displays, responses, and/or safeguards in the injector.
(193) Those familiar with the art will appreciate that various alternate sensors could be used in place of Switches 4010 and 4020, such as magnetic, optical, or mechanical. It will also be noted that a plurality of Tabs and Switches may be used to sense multiple orientations of the head.
(194) It should also be noted that the above concepts operate without regard to earth's gravitation.
(195) It will be understood by those familiar with the art that the inventions described above could be applied to any standard male luer locking connector, as found on many medical and other devices. It will also be understood that various combinations of outer and inner surfaces, combined with any of the above mentioned rear ends or flanges are possible, depending on the application.
(196) The word ‘comprising’ and forms of the word ‘comprising’ as used in this description do not limit the invention claimed to exclude any variants or additions.
(197) Modifications and improvements to the invention will be readily apparent to those skilled in the art. Such modifications and improvements are intended to be within the scope of this invention.
