Stopcock

FIELD OF THE INVENTION

0001The present invention relates to stopcocks generally, and more specifically to swabbable stopcocks.

BACKGROUND OF THE INVENTION

0002The following publications are believed to represent the current state of the art: <patcit id="pcit0001" dnum="US5549651A"><text>U.S. Patents 5,549,651</text></patcit>, <patcit id="pcit0002" dnum="USRE37357E"><text>RE 37,357</text></patcit> and <patcit id="pcit0003" dnum="US6238372B"><text>6,238,372</text></patcit> and <patcit id="pcit0004" dnum="US20040210162A" dnum-type="L"><text>U.S. Patent application 2004/0210162</text></patcit>.

0003<patcit id="pcit0005" dnum="EP1234596A1"><text>EP1234596 (A1</text></patcit>) describes a sealable access stopcock including a valve body having a switching part formed in a valve shaft thereof for switching from one flow passage to another; and a main body having an internal chamber in which the valve shaft of the valve body is rotatably fitted, and a plurality of tributary tubes each having a lumen extending therethrough, the lumen opening on a side wall of the internal chamber; the valve body being rotated to selectively bring the lumens into communication with one another through the switching part and thereby switch flow of an infusion fluid from one flow passage to another. The sealable access stopcock is characterized in that a switching channel in the form of an arcuate groove is formed in the switching part of the valve shaft to extend along the circumferential surface thereof.

SUMMARY OF THE INVENTION

0004The present invention seeks to provide an improved swabbable stopcock device.

0005There is thus provided in accordance with a preferred embodiment of the present invention a stopcock defined in claim 1.

0006Preferably, the handle element and the housing element are arrangeable in multiple mutual positions wherein the at least one fluid passageway is configured for enabling flushing the internal volume of at least one of the first, second and third ports when the housing element and the handle element are in at least one of the multiple mutual positions.

0007Preferably, the stopcock also includes at least one valve, which is associated with at least one of the first, second and third ports. Additionally, the valve includes an elastomeric element and the at least one fluid passageway is configured for providing a fluid flow which is sealed from the elastomeric element when the housing element and the handle are in another one of the mutual positions.

0008Additionally, the at least one fluid passageway is defined by a shaft portion of the handle element.

0009Preferably, the fluid flow guide enables flushing of the internal volume of the at least one of the first, second and third ports when the housing element and the handle element are in the at least one of the mutual positions by the fluid flow which does not flow entirely through the port whose internal volume is being flushed.

0010The at least one fluid passageway may be defined by at least one bore formed within the shaft portion of the handle element.

0011Preferably, the fluid flow guide includes a concave outward facing edge. Alternatively, the fluid flow guide includes an outward facing edge adapted to prevent flow of liquid when the fluid flow guide is not located opposite at least one of the ports. Additionally, at least one of the at least one port is bifurcated by the fluid flow guide.

0012Preferably, the housing element includes a side recess located within a central bore of the housing element.

0013There is also provided in accordance with another preferred embodiment of the present invention an arterial monitoring set defined in claim 12.

0014There is further provided in accordance with yet another preferred embodiment of the present invention a method of providing fluid communication with the circulatory system of a patient defined in claim 13.

0015Preferably, the flow of the first fluid passes through the stopcock from the second port to the third port and the flow of the second fluid passes through the stopcock from the first port to the third port. Alternatively, the flow of the first fluid passes through the stopcock from the third port to the second port and the flow of the second fluid passes through the stopcock from the third port to the first port.

0016Preferably, the stopcock also includes at least one valve, which is associated with at least one of the first, second and third ports. Additionally, the valve includes an elastomeric. element and the at least one fluid passageway is configured for providing a fluid flow which is sealed from the elastomeric element when the housing element and the handle are in a third mutual position.

BRIEF DESCRIPTION OF THE DRAWINGS

0017The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which: <ul id="ul0001" list-style="none" compact="compact"><li><figref idref="f0001">Fig. 1</figref> is a simplified exploded view illustration of a stopcock constructed and operative in accordance with a preferred embodiment of the present invention;</li><li><figref idref="f0002">Figs. 2 and 3</figref> are simplified pictorial illustrations of a housing element, and a threaded plug, which form part of the stopcock of <figref idref="f0001">Fig. 1</figref> taken in two different directions;</li><li><figref idref="f0003">Figs. 4A and 4B</figref> are sectional illustrations taken along section lines IVA - IVA and IVB - IVB in <figref idref="f0002">Figs. 2 and 3</figref>, respectively;</li><li><figref idref="f0004">Figs. 5A and 5B</figref> are simplified pictorial illustrations of a handle element which forms part of the stopcock of <figref idref="f0001">Fig. 1</figref> in two orientations;</li><li><figref idref="f0005">Figs. 6A and 6B</figref> are simplified plan view illustrations of the handle element of <figref idref="f0004">Figs. 5A and 5B</figref> taken along respective directions A and B in <figref idref="f0004">Fig. 5A</figref>;</li><li><figref idref="f0006">Figs. 7, 8A and 8B</figref> are sectional illustrations taken along section lines VII - VII, VIIIA - VIIIA and VIIIB - VIIIB in <figref idref="f0004">Fig. 5B</figref>;</li><li><figref idref="f0007">Figs. 9A, 9B</figref>, <figref idref="f0008">9C, 9D</figref> and <figref idref="f0009">9E</figref> are simplified pictorial illustrations of the stopcock of <figref idref="f0001">Fig. 1</figref> in five operative orientations;</li><li><figref idref="f0010">Figs. 10A, 10B</figref>, <figref idref="f0011">10C, 10D</figref> and <figref idref="f0012">10E</figref> are sectional illustrations taken along section lines XA - XA, XB - XB, XC - XC, XD - XD and XE - XE in <figref idref="f0007">Figs. 9A, 9B</figref>, <figref idref="f0008">9C, 9D</figref> and <figref idref="f0009">9E</figref> respectively;</li><li><figref idref="f0013">Fig. 11</figref> is a simplified exploded view illustration of a stopcock constructed and operative in accordance with another preferred embodiment of the present invention;</li><li><figref idref="f0014">Figs. 12 and 13</figref> are simplified pictorial illustrations of a housing element, which forms part of the stopcock of <figref idref="f0013">Fig. 11</figref> taken in two different directions;</li><li><figref idref="f0015">Figs. 14A and 14B</figref> are sectional illustrations taken along section lines XIVA - XIVA and XIVB - XIVB in <figref idref="f0014">Figs. 12 and 13</figref>, respectively;</li><li><figref idref="f0016">Figs. 15A and 15B</figref> are simplified pictorial illustrations of a handle element which forms part of the stopcock of <figref idref="f0013">Fig. 11</figref> in two orientations;</li><li><figref idref="f0017">Figs. 16A and 16B</figref> are simplified plan view illustrations of the handle element of <figref idref="f0016">Figs. 15A and 15B</figref> taken along respective directions A and B in <figref idref="f0016">Fig. 15A</figref>;</li><li><figref idref="f0018">Figs. 17, 18A and 18B</figref> are sectional illustrations taken along section lines XVII - XVII, XVIIIA - XVIIIA and XVIIIB - XVIIIB in <figref idref="f0016">Fig. 15B</figref>;</li><li><figref idref="f0019">Figs. 19A, 19B</figref>, <figref idref="f0020">19C and 19D</figref> are simplified pictorial illustrations of the stopcock of <figref idref="f0013">Fig. 11</figref> in four operative orientations;</li><li><figref idref="f0021">Figs. 20A, 20B</figref>, <figref idref="f0022">20C and 20D</figref> are sectional illustrations taken along section lines XXA - XXA, XXB - XXB, XXC - XXC and XXD - XXD in <figref idref="f0019">Figs. 19A, 19B</figref>, <figref idref="f0020">19C and 19D</figref> respectively;</li><li><figref idref="f0023">Fig. 21</figref> is a simplified exploded view illustration of a stopcock constructed and operative in accordance with an additional preferred embodiment of the present invention;</li><li><figref idref="f0024">Figs. 22 and 23</figref> are simplified pictorial illustrations of a housing element, which forms part of the stopcock of <figref idref="f0023">Fig. 21</figref> taken in two different directions;</li><li><figref idref="f0025">Figs. 24A and 24B</figref> are sectional illustrations taken along section lines XXIVA - XXIVA and XXIVB - XXIVB in <figref idref="f0024">Figs. 22 and 23</figref>, respectively;</li><li><figref idref="f0026">Figs. 25A and 25B</figref> are simplified pictorial illustrations of a handle element which forms part of the stopcock of <figref idref="f0023">Fig. 21</figref> in two orientations;</li><li><figref idref="f0027">Figs. 26A and 26B</figref> are simplified plan view illustrations of the handle element of <figref idref="f0026">Figs. 25A and 25B</figref> taken along respective directions A and B in <figref idref="f0026">Fig. 25A</figref>;</li><li><figref idref="f0028">Figs. 27, 28A and 28B</figref> are sectional illustrations taken along section lines XXVII - XXVII, XXVIIIA - XXVIIIA and XXVIIIB - XXVIIIB in <figref idref="f0026">Fig. 25B</figref>;</li><li><figref idref="f0029">Figs. 29A, 29B</figref>, <figref idref="f0030">29C and 29D</figref> are simplified pictorial illustrations of the stopcock of <figref idref="f0023">Fig. 21</figref> in four operative orientations;</li><li><figref idref="f0031">Figs. 30A, 30B</figref>, <figref idref="f0032">30C and 30D</figref> are sectional illustrations taken along section lines XXXA - XXXA, XXXB - XXXB, XXXC - XXXC and XXXD - XXXD in <figref idref="f0029">Figs. 29A, 29B</figref>, <figref idref="f0030">29C and 29D</figref> respectively;</li><li><figref idref="f0033">Fig. 31</figref> is a simplified exploded view illustration of a stopcock constructed and operative in accordance with a further preferred embodiment of the present invention;</li><li><figref idref="f0034">Figs. 32 and 33</figref> are simplified pictorial illustrations of a housing element, which forms part of the stopcock of <figref idref="f0033">Fig. 31</figref> taken in two different directions;</li><li><figref idref="f0035">Figs. 34A and 34B</figref> are sectional illustrations taken along section lines XXXIVA - XXXIVA and XXXIVB - XXXIVB in <figref idref="f0034">Figs. 32 and 33</figref>, respectively;</li><li><figref idref="f0036">Figs. 35A and 35B</figref> are simplified pictorial illustrations of a handle element which forms part of the stopcock of <figref idref="f0033">Fig. 31</figref> in two orientations;</li><li><figref idref="f0037">Figs. 36A and 36B</figref> are simplified plan view illustrations of the handle element of <figref idref="f0036">Figs. 35A and 35B</figref> taken along respective directions A and B in <figref idref="f0036">Fig. 35A</figref>;</li><li><figref idref="f0038">Figs. 37, 38A and 38B</figref> are sectional illustrations taken along section lines XXXVII - XXXVII, XXXVIIIA - XXXVIIIA and XXXVIIIB - XXXVIIIB in <figref idref="f0036">Fig. 35B</figref>;</li><li><figref idref="f0039">Figs. 39A, 39B</figref>, <figref idref="f0040">39C and 39D</figref> are simplified pictorial illustrations of the stopcock of <figref idref="f0033">Fig. 31</figref> in four operative orientations;</li><li><figref idref="f0041">Figs. 40A, 40B</figref>, <figref idref="f0042">40C and 40D</figref> are sectional illustrations taken along section lines XLA - XLA, XLB - XLB, XLC - XLC and XLD - XLD in <figref idref="f0039">Figs. 39A, 39B</figref>, <figref idref="f0040">39C and 39D</figref> respectively;</li><li><figref idref="f0043">Fig. 41</figref> is a simplified exploded view illustration of a stopcock constructed and operative in accordance with yet another preferred embodiment of the present invention;</li><li><figref idref="f0044">Figs. 42 and 43</figref> are simplified pictorial illustrations of a housing element, which forms part of the stopcock of <figref idref="f0043">Fig. 41</figref> taken in two different directions;</li><li><figref idref="f0045">Figs. 44A and 44B</figref> are sectional illustrations taken along section lines XLIVA - XLIVA and XLIVB - XLIVB in <figref idref="f0044">Figs. 42 and 43</figref>, respectively;</li><li><figref idref="f0046">Figs. 45A and 45B</figref> are simplified pictorial illustrations of a handle element which forms part of the stopcock of <figref idref="f0043">Fig. 41</figref> in two operative orientations;</li><li><figref idref="f0047">Figs. 46A and 46B</figref> are simplified plan view illustrations of the handle element of <figref idref="f0046">Figs. 45A and 45B</figref> taken along respective directions A and B in <figref idref="f0046">Fig. 45A</figref>;</li><li><figref idref="f0048">Figs. 47, 48A and 48B</figref> are sectional illustrations taken along section lines XLVII - XLVII, XLVIIIA - XLVIIIA and XLVIIIB - XLVIIIB in <figref idref="f0046">Fig. 45B</figref>;</li><li><figref idref="f0049">Figs. 49A, 49B</figref>, <figref idref="f0050">49C and 49D</figref> are simplified pictorial illustrations of the stopcock of <figref idref="f0043">Fig. 41</figref> in four operative orientations;</li><li><figref idref="f0051">Figs. 50A, 50B</figref>, <figref idref="f0052">50C and 50D</figref> are sectional illustrations taken along section lines LA - LA, LB - LB, LC - LC and LD - LD in <figref idref="f0049">Figs. 49A, 49B</figref>, <figref idref="f0050">49C and 49D</figref> respectively;</li><li><figref idref="f0053">Fig. 51</figref> is a simplified exploded view illustration of a stopcock constructed and operative in accordance with a further preferred embodiment of the present invention;</li><li><figref idref="f0054">Figs. 52 and 53</figref> are simplified pictorial illustrations of a housing element, which forms part of the stopcock of <figref idref="f0053">Fig. 51</figref> taken in two different directions;</li><li><figref idref="f0055">Figs. 54A and 54B</figref> are sectional illustrations taken along section lines LIVA - LIVA and LIVB - LIVB in <figref idref="f0054">Fig. 53</figref>;</li><li><figref idref="f0056">Figs. 55A and 55B</figref> are simplified pictorial illustrations of a handle element which forms part of the stopcock of <figref idref="f0053">Fig. 51</figref> in two operative orientations;</li><li><figref idref="f0057">Figs. 56A and 56B</figref> are simplified plan view illustrations of the handle element of <figref idref="f0056">Figs. 55A and 55B</figref> taken along respective directions A and B in <figref idref="f0056">Fig. 55A</figref>;</li><li><figref idref="f0058">Figs. 57, 58A and 58B</figref> are sectional illustrations taken along section lines LVII - LVII, LVIIIA - LVIIIA and LVIIIB - LVIIIB in <figref idref="f0056">Fig. 55B</figref>;</li><li><figref idref="f0059">Figs. 59A, 59B</figref>, <figref idref="f0060">59C and 59D</figref> are simplified pictorial illustrations of the stopcock of <figref idref="f0053">Fig. 51</figref> in four operative orientations;</li><li><figref idref="f0061">Figs. 60A, 60B</figref>, <figref idref="f0062">60C and 60D</figref> are sectional illustrations taken along section lines LXA - LXA, LXB - LXB, LXC - LXC and LXD - LXD in <figref idref="f0059">Figs. 59A, 59B</figref>, <figref idref="f0060">59C and 59D</figref> respectively; and</li><li><figref idref="f0063">Figs. 61A</figref>, <figref idref="f0064">61B</figref> and <figref idref="f0065">61C</figref> are simplified pictorial illustrations of an arterial monitoring set constructed and operative in accordance with a preferred embodiment of the present invention in various operative orientations.</li></ul>

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

0018Reference is now made to <figref idref="f0001">Fig. 1</figref>, which is an exploded view illustration of a stopcock, constructed and operative in accordance with a preferred embodiment of the present invention. As seen in <figref idref="f0001">Fig. 1</figref>, the stopcock comprises a housing element 10 including a main tubular portion 12 and three side ports, designated by reference numerals 14, 16 and 18 respectively. A handle element 20 is arranged to be seated within main tubular portion 12 of housing element 10. A typical threaded plug 23 is adapted to be connected to side port 16.

0019Reference is now made additionally to <figref idref="f0002">Figs. 2 and 3</figref> which are pictorial illustrations of housing element 10 and to <figref idref="f0003">Figs. 4A and 4B</figref> which are sectional illustrations thereof. As seen in <figref idref="f0001 f0002 f0003">Figs. 1 - 4B</figref>, tubular portion 12 of housing element 10 is generally cylindrical, arranged about an axis 22, and has side ports 14, 16 and 18 extending in different directions therefrom, typically separated by 90 degrees about axis 22. Port 14 is preferably a male port which preferably meets luer standard ISO 594-1, while ports 16 and 18 are preferably female ports, which preferably meet luer standard ISO 594-1. Conventional plugs, nuts and covers may be used in association with ports 14, 16 and 18. As seen particularly in <figref idref="f0001 f0002">Figs. 1 - 3</figref>, threaded plug 23 is shown arranged for sealing engagement with port 16. Tubular portion 12 includes a central bore 24 having a slightly conical configuration, which is formed with a circumferential undercut 26. Port 16 defines an internal volume 25.

0020Reference is now made to <figref idref="f0004 f0005 f0006">Figs. 5A - 8B</figref>, which illustrate handle element 20. As seen in <figref idref="f0004 f0005 f0006">Figs. 5A - 8B</figref>, the handle element includes a shaft portion 30, which is integrally formed with a top portion 32 from which extends a finger-engageable protrusion 34. It is appreciated that any other suitable general configuration of the top portion of the handle element may alternatively be employed.

0021Shaft portion 30 is generally symmetrical about a shaft axis 42 and has a slightly conical outer surface 44, typically having an angle α (as seen particularly in <figref idref="f0005">Fig. 6A</figref>) of 3 - 4 degrees, which corresponds to the slightly conical configuration of central bore 24 for rotatable sealing engagement therewith. As seen particularly in <figref idref="f0006">Figs. 8A and 8B</figref>, shaft portion 30 is typically formed with mutually sealed top and bottom cylindrical recesses 46 and 48, which are sealingly separated by a divider 50.

0022Disposed generally between recesses 46 and 48 and sealed therefrom is a partially peripherally-extending recess 52, selectably defining a fluid flow passageway between selectable ones of side ports 14, 16 and 18 depending on the rotational orientation of the handle element 20 relative to the housing element 10. Preferably extending radially and partially bifurcating the recess 52 is a fluid flow guide 54, which directs the flow of liquid between ports 14 and 18 through the passageway defined by recess 52 into the internal volume 25 of port 16 for flushing thereof, when the handle element 20 is suitably positioned. The radially outward facing edge 56 of fluid flow guide 54 is formed with a concave configuration.

0023Reference is now made to <figref idref="f0007">Figs. 9A, 9B</figref>, <figref idref="f0008">9C, 9D</figref> and <figref idref="f0009">9E</figref>, which are simplified pictorial illustrations of the stopcock of <figref idref="f0001">Fig. 1</figref> in five operative orientations and to <figref idref="f0010">Figs. 10A, 10B</figref>, <figref idref="f0011">10C, 10D</figref> and <figref idref="f0012">10E</figref>, which are sectional illustrations of the stopcock of <figref idref="f0007">Figs. 9A, 9B</figref>, <figref idref="f0008">9C, 9D</figref> and <figref idref="f0009">9E</figref> respectively.

0024<figref idref="f0007">Figs. 9A</figref> and <figref idref="f0010">10A</figref> illustrate a first operating position of the stopcock of <figref idref="f0001">Fig. 1</figref> when port 16 is sealed as by threaded plug 23. The user typically connects a source of pressurized fluid, such as an IV set, to port 18 and the liquid flows through port 18 and partially peripherally-extending recess 52 and past the concave edge 56 of fluid flow guide 54 via port 14 to the patient, as indicated by an arrow 60.

0025<figref idref="f0007">Figs. 9B</figref> and <figref idref="f0010">10B</figref> illustrate a second operating position of the stopcock of <figref idref="f0001">Fig. 1</figref>, which is typically employed for drawing blood or other fluids from the patient. The user typically connects a syringe (not shown) to port 16 and draws blood from the patient through port 14 and partially peripherally-extending recess 52 through port 16 to the syringe, as indicated by an arrow 62. It is appreciated that this operating position may also be used for supplying a medicament to the patient when port 18 is closed, in a flow direction opposite to that indicated by arrow 62.

0026<figref idref="f0008">Figs. 9C</figref> and <figref idref="f0011">10C</figref> illustrate a third operating position of the stopcock of <figref idref="f0001">Fig. 1</figref>, which is typically employed for supplying a medicament to the patient when port 16 is open or connected to a secondary line (not shown). A secondary line may be a source of medicament. The medicament flows through port 16 and partially peripherally-extending recess 52 through port 14 to the patient, as indicated by an arrow 63. At the same time, liquid flows via port 18 and partially peripherally-extending recess 52, around fluid flow guide 54, and slightly into the internal volume 25 of port 16, via port 14 to the patient, as indicated by an arrow 64.

0027<figref idref="f0008">Figs. 9D</figref> and <figref idref="f0011">10D</figref> illustrate a fourth operating position of the stopcock of <figref idref="f0001">Fig. 1</figref>, which is typically employed for supplying a liquid to the patient from port 18 to port 14, when port 16 is sealed as by threaded plug 23. Liquid flows via port 18 and partially peripherally-extending recess 52, around fluid flow guide 54, and into the internal volume 25 of port 16, flushing residual liquid therefrom, via port 14 to the patient, as indicated by an arrow 66.

0028It is a particular feature of the present invention that the provision of fluid flow guide 54 generally overcomes problems of the presence of residual liquids remaining in the internal volume 25 of port 16. This is important in various therapeutic situations. For example when blood is drawn from the patient through port 16, there remains residual blood in the internal volume 25 of port 16. This blood, if left in internal volume 25 for a period of time, can clot and thus become dangerous if delivered to the patient. In addition, the coagulated blood could occlude the liquid passageway extending through port 16. Various infections could possibly arise as a result of the retained blood.

0029This feature is also useful when a medicament is supplied to a patient through port 16. If a portion of the medicament remains in the internal volume 25 of port 16, the dosage of the medicament that the patient receives is less than the intended dosage by an amount which cannot be readily ascertained. In addition, this residual medicament might be inadvertently supplied to the patient during a subsequent use of the stopcock, which could cause harm to the patient.

0030The present invention provides for automatic flushing of the liquid, such as blood or medicament, from the internal volume 25 and typically returning it to the patient without requiring the use of extra syringes, the manipulation of the threaded plug 23 and opening the medical set to the atmosphere, which could increase the chance of contamination.

0031<figref idref="f0009">Figs. 9E</figref> and <figref idref="f0012">10E</figref> illustrate a fifth operating position of the stopcock of <figref idref="f0001">Fig. 1</figref>, which may be used for flushing the IV set upstream of the stopcock, when port 16 is open to the atmosphere. Liquid flows via port 18, around fluid flow guide 54 and through partially peripherally-extending recess 52, to the atmosphere via port 16, as indicated by an arrow 68. Alternatively, this operating position may be employed for pushing liquid via the side port 16 and through port 18 in a direction opposite arrow 68, for example when it is desired to mix liquid in the pressure bag.

0032Reference is now made to <figref idref="f0013">Fig. 11</figref>, which is an exploded view illustration of a stopcock constructed and operative in accordance with a preferred embodiment of the present invention. As seen in <figref idref="f0013">Fig. 11</figref>, the stopcock comprises a housing element 110 including a main tubular portion 112 and three side ports, designated by reference numerals 114, 116 and 118 respectively. A handle element 120 is arranged to be seated within main tubular portion 112 of housing element 110.

0033Reference is now made additionally to <figref idref="f0014">Figs. 12 and 13</figref> which are pictorial illustrations of housing element 110 and to <figref idref="f0015">Figs. 14A and 14B</figref> which are sectional illustrations thereof. As seen in <figref idref="f0013 f0014 f0015">Figs. 11 - 14B</figref>, tubular portion 112 of housing element 110 is generally cylindrical, arranged about an axis 122, and has side ports 114, 116 and 118 extending in different directions therefrom, typically separated by 90 degrees about axis 122. Port 114 is preferably a male port which preferably meets luer standard ISO 594-1, while port 116 incorporates a normally closed swabbable valve which is configured to receive a male luer and port 118 is preferably a female port, which preferably meets luer standard ISO 594-1. Conventional plugs, nuts and covers may be used in association with ports 114 and 118.

0034Port 116 of housing element 110 includes a valve employing an elastomeric element 123, held in place by a cap 124, which is welded or otherwise fixed to housing element 110. Elastomeric element 123 and cap 124 are commercially available from Halkey-Roberts Corporation of St. Petersburg, Florida, USA and described in one or more of <patcit id="pcit0006" dnum="US6651956B"><text>U.S. Patents 6,651,956</text></patcit>; <patcit id="pcit0007" dnum="US6089541A"><text>6,089,541</text></patcit> and <patcit id="pcit0008" dnum="US6036171A"><text>6,036,171</text></patcit>. Alternatively, valves and valve elements commercially available from other sources such as Becton-Dickinson, Cardinal, Medegen and Filtertek may be employed.

0035Tubular portion 112 includes a central bore 125 having a slightly conical configuration, which is formed with a circumferential undercut 126. Port 116 defines an internal volume 127.

0036Reference is now made to <figref idref="f0016 f0017 f0018">Figs. 15A - 18B</figref>, which illustrate handle element 120. As seen in <figref idref="f0016 f0017 f0018">Figs. 15A - 18B</figref>, the handle element includes a shaft portion 130, which is integrally formed with a top portion 132 from which extends a finger-engageable protrusion 134. It is appreciated that any other suitable general configuration of the top portion of the handle element may alternatively be employed.

0037Shaft portion 130 is generally symmetrical about a shaft axis 142 and has a slightly conical outer surface 144, typically having an angle α (as seen particularly in <figref idref="f0017">Fig. 16A</figref>) of 3 - 4 degrees, which corresponds to the slightly conical configuration of central bore 125 for rotatable sealing engagement therewith. As seen particularly in <figref idref="f0018">Figs. 18A and 18B</figref>, shaft portion 130 is typically formed with mutually sealed top and bottom cylindrical recesses 146 and 148, which are sealingly separated by a divider 150.

0038Disposed generally between recesses 146 and 148 and sealed therefrom is a partially peripherally-extending recess 152, selectably defining a fluid flow passageway between selectable ones of side ports 114, 116 and 118 depending on the rotational orientation of the handle element 120 relative to the housing element 110. Preferably extending radially and partially bifurcating the recess 152 is a fluid flow guide 154, which directs the flow of liquid between ports 114 and 118 through the passageway defined by recess 152 into the internal volume 127 of port 116 for flushing thereof, when the handle element 120 is suitably positioned. The radially outward facing edge 156 of fluid flow guide 154 is formed with a concave configuration.

0039Reference is now made to <figref idref="f0019">Figs. 19A, 19B</figref>, <figref idref="f0020">19C and 19D</figref>, which are simplified pictorial illustrations of the stopcock of <figref idref="f0013">Fig. 11</figref> in four operative orientations and to <figref idref="f0021">Figs. 20A, 20B</figref>, <figref idref="f0022">20C and 20D</figref>, which are sectional illustrations of the stopcock of <figref idref="f0019">Figs. 19A, 19B</figref>, <figref idref="f0020">19C and 19D</figref>, respectively.

0040<figref idref="f0019">Figs. 19A</figref> and <figref idref="f0021">20A</figref> illustrate a first operating position of the stopcock of <figref idref="f0013">Fig. 11</figref>. The user typically connects a source of pressurized fluid, such as an IV set, to port 118 and the liquid flows through port 118 and partially peripherally-extending recess 152 and past the concave edge 156 of fluid flow guide 154 via port 114 to the patient, as indicated by an arrow 160.

0041<figref idref="f0019">Figs. 19B</figref> and <figref idref="f0021">20B</figref> illustrate a second operating position of the stopcock of <figref idref="f0013">Fig. 11</figref>, which is typically employed for drawing blood or other fluids from the patient. The user typically connects a syringe to port 116 and draws blood from the patient through port 114 and partially peripherally-extending recess 152 through port 116 to the syringe, as indicated by an arrow 162. It is appreciated that this operating position may also be used for supplying a medicament to the patient when port 118 is closed, in a flow direction opposite to that indicated by arrow 162.

0042<figref idref="f0020">Figs. 19C</figref> and <figref idref="f0022">20C</figref> illustrate a third operating position of the stopcock of <figref idref="f0013">Fig. 11</figref>, which is typically employed for supplying a liquid to the patient from port 118 to port 114. Liquid flows via port 118 and partially peripherally-extending recess 152, around fluid flow guide 154, and into the internal volume 127 of port 116 as well as an internal volume 166 of the elastomeric element 123, flushing residual liquid therefrom, via port 114 to the patient, as indicated by an arrow 164.

0043It is a particular feature of the present invention that the provision of fluid flow guide 154 generally overcomes problems of the presence of residual liquids remaining in the internal volume 127 of port 116 as well as in internal volume 166 of the elastomeric element 123. This is important in various therapeutic situations. For example when blood is drawn from the patient through port 116, there remains residual blood in the internal volumes 127 of port 116 and 166 of elastomeric element 123. This blood, if left in internal volumes 127 and 166 for a period of time, can clot and thus become dangerous if delivered to the patient. In addition, the coagulated blood could occlude the liquid passageway extending through port 116. Various infections could possibly arise as a result of the retained blood.

0044This feature is also useful when a medicament is supplied to a patient through port 116. If a portion of the medicament remains in the internal volumes 127 of port 116 and 166 of the elastomeric element 123, the dosage of the medicament that the patient receives is less than the intended dosage by an amount which cannot be readily ascertained. In addition, this residual medicament might be inadvertently supplied to the patient during a subsequent use of the stopcock, which could cause harm to the patient.

0045The present invention provides for automatic flushing of the liquid, such as blood or medicament, from the internal volumes 127 and 166 and typically returning it to the patient without requiring the use of extra syringes and the opening of the medical set to the atmosphere, thereby increasing the chance of contamination.

0046<figref idref="f0020">Figs. 19D</figref> and <figref idref="f0022">20D</figref> illustrate a fourth operating position of the stopcock of <figref idref="f0013">Fig. 11</figref>, which may be used for flushing the IV set upstream of the stopcock, when port 116 is open to the atmosphere as by insertion of a male hier connector, such as a syringe tip (not shown), into the elastomeric element 123 of the valve thereof. The insertion of the male luer connector activates the flow of liquid from port 118, around fluid flow guide 154 and through partially peripherally-extending recess 152, to the male luer connector via the elastomeric element 123 of port 116, as indicated by an arrow 165. Alternatively, this operating position may be employed for pushing liquid via the side port 116 and through port 118 in a direction opposite arrow 165, for example when it is desired to mix liquid in the pressure bag.

0047Reference is now made to <figref idref="f0023">Fig. 21</figref>, which is an exploded view illustration of a stopcock constructed and operative in accordance with a preferred embodiment of the present invention. As seen in <figref idref="f0023">Fig. 21</figref>, the stopcock comprises a housing element 210 including a main tubular portion 212 and three side ports, designated by reference numerals 214, 216 and 218 respectively. A handle element 220 is arranged to be seated within main tubular portion 212 of housing element 210.

0048Reference is now made additionally to <figref idref="f0024">Figs. 22 and 23</figref> which are pictorial illustrations of housing element 210 and to <figref idref="f0025">Figs. 24A and 24B</figref> which are sectional illustrations thereof. As seen in <figref idref="f0023 f0024 f0025">Figs. 21 - 24B</figref>, tubular portion 212 of housing element 210 is generally cylindrical, arranged about an axis 222, and has side ports 214, 216 and 218 extending in different directions therefrom, typically separated by 90 degrees about axis 222. Port 214 is preferably a male port which preferably meets luer standard ISO 594-1, while port 216 incorporates a normally closed swabbable valve which is configured to receive a male luer and port 218 is preferably a female port, which preferably meets luer standard ISO 594-1. Conventional plugs, nuts and covers may be used in association with ports 214 and 218.

0049Port 216 of housing element 210 includes a valve employing an elastomeric element 223, held in place by a cap 224, which is welded or otherwise fixed to housing element 110. Elastomeric element 123 and cap 124 are commercially available from Halkey-Roberts Corporation of St. Petersburg, Florida, USA and described in one or more of <patcit id="pcit0009" dnum="US6651956B"><text>U.S. Patents 6,651,956</text></patcit>; <patcit id="pcit0010" dnum="US6089541A"><text>6,089,541</text></patcit>- and <patcit id="pcit0011" dnum="US6036171A"><text>6,036,171</text></patcit>. Alternatively, valves and valve elements commercially available from other sources such as Becton-Dickinson, Cardinal, Medegen and Filtertek may be employed.

0050Tubular portion 212 includes a central bore 225 having a slightly conical configuration, which is formed with a circumferential undercut 226. Port 216 defines an internal volume 227.

0051Reference is now made to <figref idref="f0026 f0027 f0028">Figs. 25A - 28B</figref>, which illustrate handle element 220. As seen in <figref idref="f0026 f0027 f0028">Figs. 25A - 28B</figref>, the handle element includes a shaft portion 230, which is integrally formed with a top portion 232 from which extends a finger-engageable protrusion 234. It is appreciated that any other suitable general configuration of the top portion of the handle element may alternatively be employed.

0052Shaft portion 230 is generally symmetrical about a shaft axis 242 and has a slightly conical outer surface 244, typically having an angle α (as seen particularly in <figref idref="f0027">Fig. 26A</figref>) of 3 - 4 degrees, which corresponds to the slightly conical configuration of central bore 225 for rotatable sealing engagement therewith. As seen particularly in <figref idref="f0028">Figs. 28A and 28B</figref>, shaft portion 230 is typically formed with mutually sealed top and bottom cylindrical recesses 246 and 248, which are sealingly separated by a divider 250.

0053Disposed generally between recesses 246 and 248 and sealed therefrom is a partially peripherally-extending recess 252, selectably defining a fluid flow passageway between selectable ones of side ports 214, 216 and 218 depending on the rotational orientation of the handle element 220 relative to the housing element 210. Preferably extending radially and partially bifurcating the recess 252 is a fluid flow guide 254, which directs the flow of liquid between ports 214 and 218 through the passageway defined by recess 252 into the internal volume 227 of port 216 for flushing thereof, when the handle element 220 is suitably positioned. The radially outward facing edge 256 of fluid flow guide 254 is formed with a suitably tapered configuration in order to prevent liquid flow therepast when fluid flow guide 254 is not located opposite a port.

0054Reference is now made to <figref idref="f0029">Figs. 29A, 29B</figref>, <figref idref="f0030">29C and 29D</figref>, which are simplified pictorial illustrations of the stopcock of <figref idref="f0023">Fig. 21</figref> in four operative orientations and to <figref idref="f0031">Figs. 30A, 30B</figref>, <figref idref="f0032">30C and 30D</figref>, which are sectional illustrations of the stopcock of <figref idref="f0029">Figs. 29A, 29B</figref>, <figref idref="f0030">29C and 29D</figref>, respectively.

0055<figref idref="f0029">Figs. 29A</figref> and <figref idref="f0031">30A</figref> illustrate a first operating position of the stopcock of <figref idref="f0023">Fig. 21</figref>. As seen, there is no fluid communication between any of the ports. Liquid does not flow from port 218 to port 214, because it is blocked by fluid flow guide 254, whose edge 256 sealingly engages an inner facing wall 257 of bore 225 of housing element 210. This orientation may be utilized to close all three ports.

0056The operative orientation shown in <figref idref="f0029">Figs. 29A</figref> and <figref idref="f0031">30A</figref> may be advantageously employed when it is desired to prevent all flow of liquid through the stopcock. The procedure currently used requires careful placement of the handle to an angle 45 degrees from one of the ports. Such a procedure is unreliable and requires careful attention of the operator, which may be a doctor or a nurse in the middle of a surgery.

0057<figref idref="f0029">Figs. 29B</figref> and <figref idref="f0031">30B</figref> illustrate a second operating position of the stopcock of <figref idref="f0023">Fig. 21</figref>, which is typically employed for drawing blood or other fluids from the patient. The user typically connects a syringe to port 216 and draws blood from the patient through port 214 and partially peripherally-extending recess 252 through port 216 to the syringe, as indicated by an arrow 262. It is appreciated that this operating position may also be used for supplying a medicament to the patient when port 218 is closed, in a flow direction opposite to that indicated by arrow 262.

0058<figref idref="f0030">Figs. 29C</figref> and <figref idref="f0032">30C</figref> illustrate a third operating position of the stopcock of <figref idref="f0023">Fig. 21</figref>, which is typically employed for supplying a liquid to the patient from port 218 to port 214. Liquid flows via port 218 and partially peripherally-extending recess 252, around fluid flow guide 254, and into the internal volume 227 of port 216 as well as an internal volume 266 of the elastomeric element 223, flushing residual liquid therefrom, via port 214 to the patient, as indicated by an arrow 264.

0059It is a particular feature of the present invention that the provision of fluid flow guide 254 generally overcomes problems of the presence of residual liquids remaining in the internal volume 227 of port 216 as well as in internal volume 266 of the elastomeric element 223. This is important in various therapeutic situations. For example when blood is drawn from the patient through port 216, there remains residual blood in the internal volumes 227 of port 216 and 266 of the elastomeric element 223. This blood, if left in internal volumes 227 and 266 for a period of time, can clot and thus become dangerous if delivered to the patient. In addition, the coagulated blood could occlude the liquid passageway extending through port 216. Various infections could possibly arise as a result of the retained blood.

0060This feature is also useful when a medicament is supplied to a patient through port 216. If a portion of the medicament remains in the internal volumes 227 of port 216 and 266 of the elastomeric element 223, the dosage of the medicament that the patient receives is less than the intended dosage by an amount which cannot be readily ascertained. In addition, this residual medicament might be inadvertently supplied to the patient during a subsequent use of the stopcock, which could cause harm to the patient.

0061The present invention provides for automatic flushing of the liquid, such as blood or medicament from the internal volumes 227 and 266 and typically returning it to the patient without requiring the use of extra syringes and the opening of the medical set to the atmosphere, thereby increasing the chance of contamination.

0062<figref idref="f0030">Figs. 29D</figref> and <figref idref="f0032">30D</figref> illustrate a fourth operating position of the stopcock of <figref idref="f0023">Fig. 21</figref>, which may be used for flushing the IV set upstream of the stopcock, when port 216 is open to the atmosphere as by insertion of a male luer connector, such as a syringe tip (not shown), into the elastomeric element 223 of the valve thereof. The insertion of the male luer connector activates the flow of liquid from port 218, around fluid flow guide 254 and through partially peripherally-extending recess 252, to the male luer connector via the elastomeric element 223 of port 216, as indicated by an arrow 265. Alternatively, this operating position may be employed for pushing liquid via the side port 216, through port 218, in a direction opposite arrow 265 for uses such as mixing liquid in the pressure bag.

0063Reference is now made to <figref idref="f0033">Fig. 31</figref>, which is an exploded view illustration of a stopcock constructed and operative in accordance with a preferred embodiment of the present invention. As seen in <figref idref="f0033">Fig. 31</figref>, the stopcock comprises a housing element 310 including a main tubular portion 312 and three side ports, designated by reference numerals 314, 316 and 318 respectively. A handle element 320 is arranged to be seated within main tubular portion 312 of housing element 310.

0064Reference is now made additionally to <figref idref="f0034">Figs. 32 and 33</figref> which are pictorial illustrations of housing element 310 and to <figref idref="f0035">Figs. 34A and 34B</figref> which are sectional illustrations thereof. As seen in <figref idref="f0033 f0034 f0035">Figs. 31 - 34B</figref>, tubular portion 312 of housing element 310 is generally cylindrical, arranged about an axis 322, and has side ports 314, 316 and 318 extending in different directions therefrom, typically separated by 90 degrees about axis 322. Port 314 is preferably a male port which preferably meets luer standard ISO 594-1, while port 316 incorporates a normally closed swabbable valve which is configured to receive a male luer and port 318 is preferably a female port, which preferably meets luer standard ISO 594-1. Conventional plugs, nuts and covers may be used in association with ports 314 and 318.

0065Port 316 of housing element 310 includes a valve employing an elastomeric element 323 held in place by a cap 324, which is welded or otherwise fixed to housing element 310. Elastomeric element 323 and cap 324 are commercially available from Halkey-Roberts Corporation of St. Petersburg, Florida, USA and described in one or more of <patcit id="pcit0012" dnum="US6651956B"><text>U.S. Patents 6,651,956</text></patcit>; <patcit id="pcit0013" dnum="US6089541A"><text>6,089,541</text></patcit> and <patcit id="pcit0014" dnum="US6036171A"><text>6,036,171</text></patcit>. Alternatively valves and valve elements commercially available from other sources such as Becton-Dickinson, Cardinal, Medegen and Filtertek may be employed.

0066Tubular portion 312 includes a central bore 325 having a slightly conical configuration, which is formed with a circumferential undercut 326. In this embodiment, a side recess 327 is formed in a wall of bore 325 opposite port 316. Port 316 defines an internal volume 328.

0067Reference is now made to <figref idref="f0036 f0037 f0038">Figs. 35A - 38B</figref>, which illustrate handle element 320. As seen in <figref idref="f0036 f0037 f0038">Figs. 35A - 38B</figref>, the handle element includes a shaft portion 330, which is integrally formed with a top portion 332 from which extends a finger-engageable protrusion 334. It is appreciated that any other suitable general configuration of the top portion of the handle element may alternatively be employed.

0068Shaft portion 330 is generally symmetrical about a shaft axis 342 and has a slightly conical outer surface 344, typically having an angle α (as seen particularly in <figref idref="f0037">Fig. 36A</figref>) of 3 - 4 degrees, which corresponds to the slightly conical configuration of central bore 325 for rotatable sealing engagement therewith. As seen particularly in <figref idref="f0038">Figs. 38A and 38B</figref>, shaft portion 330 is typically formed with mutually sealed top and bottom cylindrical recesses 346 and 348, which are sealingly separated by a divider 350.

0069Disposed generally between recesses 346 and 348 and sealed therefrom is a partially peripherally-extending recess 352. Preferably extending radially and partially bifurcating the recess 352 is a fluid flow guide 354, which directs the flow of liquid between ports 314 and 318 through the passageway defined by recess 352 into the internal volume 328 of port 316 for flushing thereof, when the handle element 320 is 410 is generally cylindrical, arranged about an axis 422, and has side ports 414, 416 and 418 extending in different directions therefrom, typically separated by 90 degrees about suitably positioned. The thickness of fluid flow guide 354 is substantially less than the circumferential extent of side recess 327. The radially outward facing edge 356 of fluid flow guide 354 is formed with a suitably tapered configuration in order to prevent liquid flow therepast when fluid flow guide 354 is not located opposite a port.

0070Reference is now made to <figref idref="f0039">Figs. 39A, 39B</figref>, <figref idref="f0040">39C and 39D</figref>, which are simplified pictorial illustrations of the stopcock of <figref idref="f0033">Fig. 31</figref> in four operative orientations and to <figref idref="f0041">Figs. 40A, 40B</figref>, <figref idref="f0042">40C and 40D</figref>, which are sectional illustrations of the stopcock of <figref idref="f0039">Figs. 39A, 39B</figref>, <figref idref="f0040">39C and 39D</figref>, respectively.

0071<figref idref="f0039">Figs. 39A</figref> and <figref idref="f0041">40A</figref> illustrate a first operating position of the stopcock of <figref idref="f0033">Fig. 31</figref>. The user typically connects a source of pressurized fluid, such as an IV set, to port 318 and the liquid flows from port 318, around fluid flow guide 354, through side recess 327 to port 314, as indicated by arrow 360.

0072<figref idref="f0039">Figs. 39B</figref> and <figref idref="f0041">40B</figref> illustrate a second operating position of the stopcock of <figref idref="f0033">Fig. 31</figref>, which is typically employed for drawing blood or other fluids from the patient. The user typically connects a syringe to port 316 and draws blood from the patient through port 314 and partially peripherally-extending recess 352 through port 316 to the syringe, as indicated by an arrow 362. It is appreciated that this operating position may also be used for supplying a medicament to the patient when port 318 is closed, in a flow direction opposite to that indicated by arrow 362.

0073<figref idref="f0040">Figs. 39C</figref> and <figref idref="f0042">40C</figref> illustrate a third operating position of the stopcock of <figref idref="f0033">Fig. 31</figref>, which is typically employed for supplying a liquid to the patient from port 318 to port 314. Liquid flows via port 318 and partially peripherally-extending recess 352, around fluid flow guide 354, and into the internal volume 328 of port 316 as well as an internal volume 366 of the elastomeric element 323, flushing residual liquid therefrom, via port 314 to the patient, as indicated by an arrow 364.

0074It is a particular feature of the present invention that the provision of fluid flow guide 354 generally overcomes problems of the presence of residual liquids remaining in the internal volume 328 of port 316 as well as in internal volume 366 of the elastomeric element 323. This is important in various therapeutic situations. For example when blood is drawn from the patient through port 316, there remains residual blood in the internal volume 328 of port 316 and the internal volume 366 of the elastomeric element 323. This blood, if left in internal volumes 328 and 366 for a period of time, can clot and thus become dangerous if delivered to the patient. In addition, the coagulated blood could occlude the liquid passageway extending through port 316. Various infections could possibly arise as a result of the retained blood.

0075This feature is also useful when a medicament is supplied to a patient through port 316. If a portion of the medicament remains in the internal volumes 328 of port 316 and 366 of the elastomeric element 323, the dosage of the medicament that the patient receives is less than the intended dosage by an amount which cannot be readily ascertained. In addition, this residual medicament might be inadvertently supplied to the patient during a subsequent use of the stopcock, which could cause harm to the patient.

0076The present invention provides for automatic flushing of the liquid, such as blood or medicament, from the internal volumes 328 and 366 and typically returning it to the patient without requiring the use of extra syringes and the opening of the medical set to the atmosphere, thereby increasing the chance of contamination.

0077<figref idref="f0040">Figs. 39D</figref> and <figref idref="f0042">40D</figref> illustrate a fourth operating position of the stopcock of <figref idref="f0033">Fig. 31</figref>, which may be used for flushing the IV set upstream of the stopcock, when port 316 is open to the atmosphere as by insertion of a male luer connector, such as a syringe tip (not shown), into the elastomeric element 323 of the valve thereof. The insertion of the male luer connector activates the flow of liquid from port 318, around fluid flow guide 354 and through partially peripherally-extending recess 352, to the male luer connector via the elastomeric element 323 of port 316, as indicated by an arrow 365. Alternatively, this operating position may be employed for pushing liquid via the side port 316, through port 318, in a direction opposite arrow 365, for uses such as mixing liquid in the pressure bag.

0078Reference is now made to <figref idref="f0043">Fig. 41</figref>, which is an exploded view illustration of a stopcock constructed and operative in accordance with a preferred embodiment of the present invention. As seen in <figref idref="f0043">Fig. 41</figref>, the stopcock comprises a housing element 410 including a main tubular portion 412 and three side ports, designated by reference numerals 414, 416 and 418 respectively. A handle element 420 is arranged to be seated within main tubular portion 412 of housing element 410.

0079Reference is now made additionally to <figref idref="f0044">Figs. 42 and 43</figref> which are pictorial illustrations of housing element 410 and to <figref idref="f0045">Figs. 44A and 44B</figref> which are sectional illustrations thereof. As seen in <figref idref="f0043 f0044 f0045">Figs. 41- 44B</figref>, tubular portion 412 of housing element 410 is generally cylindrical, arranged about an axis 422, and has side ports 414, 416 and 418 extending in different directions therefrom, typically separated by 90 degrees about axis 422. Port 414 is preferably a male port which preferably meets luer standard ISO 594-1, while port 416 incorporates a normally closed swabbable valve which is configured to receive a male luer and port 418 is preferably a female port, which preferably meets luer standard ISO 594-1. Conventional plugs, nuts and covers may be used in association with ports 414 and 418.

0080Port 416 of housing element 410 includes a valve employing an elastomeric element 423, held in place by a cap 424, which is welded or otherwise fixed to housing element 410. Elastomeric element 423 and cap 424 are commercially available from Halkey-Roberts Corporation of St. Petersburg, Florida, USA and described in one or more of <patcit id="pcit0015" dnum="US6651956B"><text>U.S. Patents 6,651,956</text></patcit>; <patcit id="pcit0016" dnum="US6089541A"><text>6,089,541</text></patcit> and <patcit id="pcit0017" dnum="US6036171A"><text>6,036,171</text></patcit>. Alternatively, valves and valve elements commercially available from other sources such as Becton-Dickinson, Cardinal, Medegen and Filtertek may be employed.

0081Tubular portion 412 includes a central bore 425 having a slightly conical configuration, which is formed with a circumferential undercut 426. Port 416 defines an internal volume 427.

0082Reference is now made to <figref idref="f0046 f0047 f0048">Figs. 45A - 48B</figref>, which illustrate handle element 420. As seen in <figref idref="f0046 f0047 f0048">Figs. 45A - 48B</figref>, the handle element includes a shaft portion 430, which is integrally formed with a top portion 432 from which extends a finger-engageable protrusion 434. It is appreciated that any other suitable general configuration of the top portion of the handle element may alternatively be employed.

0083Shaft portion 430 is generally symmetrical about a shaft axis 442 and has a slightly conical outer surface 444, typically having an angle α (as seen particularly in <figref idref="f0047">Fig. 46A</figref>) of 3 - 4 degrees, which corresponds to the slightly conical configuration of central bore 425 for rotatable sealing engagement therewith. As seen particularly in <figref idref="f0048">Figs. 48A and 48B</figref>, shaft portion 430 is typically formed with mutually sealed top and bottom cylindrical recesses 446 and 448, which are sealingly separated by a divider 450.

0084Disposed generally between recesses 446 and 448 and sealed therefrom is a side-to-side extending bore 452 and a side bore 453 extending perpendicularly with respect thereto and communicating therewith. Bore 452 and side bore 453 are bifurcated by a fluid flow guide 454 in such a manner that fluid communication between opposite ends of bore 452 takes place via side bore 453. Bores 452 and 453 and fluid flow guide 454 define a fluid flow passageway between selectable ones of side ports 414, 416 and 418 depending on the rotational orientation of the handle element 420 relative to the housing element 410. Fluid flow guide 454 directs the flow of liquid between ports 414 and 418 through bores 452 and 453 into the internal volume 427 of port 416 for flushing thereof, when the handle element 420 is suitably positioned. The radially outward facing edge 456 of fluid flow guide 454 is formed with a suitably tapered configuration in order to prevent liquid flow therepast when fluid flow guide 454 is not located opposite a port as shown in <figref idref="f0046">Fig. 45A</figref>, alternatively it may have many other shapes.

0085Reference is now made to <figref idref="f0049">Figs. 49A, 49B</figref>, <figref idref="f0050">49C and 49D</figref>, which are simplified pictorial illustrations of the stopcock of <figref idref="f0043">Fig. 41</figref> in four operative orientations and to <figref idref="f0051">Figs. 50A, 50B</figref>, <figref idref="f0052">50C and 50D</figref>, which are sectional illustrations of the stopcock of <figref idref="f0049">Figs. 49A, 49B</figref>, <figref idref="f0050">49C and 49D</figref>, respectively.

0086<figref idref="f0049">Figs. 49A</figref> and <figref idref="f0051">50A</figref> illustrate a first operating position of the stopcock of <figref idref="f0043">Fig. 41</figref>. As seen, there is no fluid communication between any of the ports. Liquid does not flow from port 418 to port 414, because it is blocked by fluid flow guide 454, whose edge 456 sealingly engages an inner facing wall 457 of central bore 425 of housing element 410. This orientation may be utilized to close all three ports.

0087The operative orientation shown in <figref idref="f0049">Figs. 49A</figref> and <figref idref="f0051">50A</figref> may be advantageously employed when it is desired to prevent all flow of liquid through the stopcock. The procedure currently used requires careful placement of the handle to an angle 45 degrees from one of the ports. Such a procedure is unreliable and requires careful attention of the operator, which may be a doctor or a nurse in the middle of a surgery.

0088<figref idref="f0049">Figs. 49B</figref> and <figref idref="f0051">50B</figref> illustrate a second operating position of the stopcock of <figref idref="f0043">Fig. 41</figref>, which is typically employed for drawing blood or other fluids from the patient. The user typically connects a syringe to port 416 and draws blood from the patient through port 414 and bores 453 and 452 through port 416 to the syringe, as indicated by an arrow 462. It is appreciated that this operating position may also be used for supplying a medicament to the patient when port 418 is closed, in a flow direction opposite to that indicated by arrow 462.

0089<figref idref="f0050">Figs. 49C</figref> and <figref idref="f0052">50C</figref> illustrate a third operating position of the stopcock of <figref idref="f0043">Fig. 41</figref>, which is typically employed for supplying a liquid to the patient from port 418 to port 414. Liquid flows via port 418 and bores 452 and 453, around fluid flow guide 454, and into the internal volume 427 of port 416 as well as an internal volume 466 of the elastomeric element 423, flushing residual liquid therefrom, via port 414 to the patient, as indicated by an arrow 464.

0090It is a particular feature of the present invention that the provision of fluid flow guide 454 generally overcomes problems of the presence of residual liquids remaining in the internal volume 427 of port 416 as well as in internal volume 466 of the elastomeric element 423. This is important in various therapeutic situations. For example when blood is drawn from the patient through port 416, there remains residual blood in the internal volume 427 of port 416 and the internal volume 466 of the elastomeric element 423. This blood, if left in internal volumes 427 and 466 for a period of time, can clot and thus become dangerous if delivered to the patient. In addition, the coagulated blood could occlude the liquid passageway extending through port 416. Various infections could possibly arise as a result of the retained blood.

0091This feature is also useful when a medicament is supplied to a patient through port 416. If a portion of the medicament remains in the internal volumes 427 of port 416 and 466 of the elastomeric element 423, the dosage of the medicament that the patient receives is less than the intended dosage by an amount which cannot be readily ascertained. In addition, this residual medicament might be inadvertently supplied to the patient during a subsequent use of the stopcock, which could cause harm to the patient.

0092The present invention provides for automatic flushing of the liquid, such as blood or medicament from the internal volumes 427 and 466 and typically returning it to the patient without requiring the use of extra syringes and the opening of the medical set to the atmosphere, thereby increasing the chance of contamination.

0093<figref idref="f0050">Figs. 49D</figref> and <figref idref="f0052">50D</figref> illustrate a fourth operating position of the stopcock of <figref idref="f0043">Fig. 41</figref>, which may be used for flushing the IV set upstream of the stopcock, when port 416 is open to the atmosphere as by insertion of a male luer connector, such as a syringe tip (not shown), into the elastomeric element 423 of the valve thereof. The insertion of the male luer connector activates the flow of liquid from port 418, around fluid flow guide 454 and through bores 453 and 452, to the male luer connector via the elastomeric element 423 of port 416, as indicated by an arrow 465. Alternatively, this operating position may be employed for pushing liquid via the side port 416, through port 418, in a direction opposite arrow 465, for uses such as mixing liquid in the pressure bag.

0094Reference is now made to <figref idref="f0053">Fig. 51</figref>, which is an exploded view illustration of a stopcock constructed and operative in accordance with a preferred embodiment of the present invention. As seen in <figref idref="f0053">Fig. 51</figref>, the stopcock comprises a housing element 510 including a main tubular portion 512 and three side ports, designated by reference numerals 514, 516 and 518 respectively. A handle element 520 is arranged to be seated within main tubular portion 512 of housing element 510.

0095Reference is now made additionally to <figref idref="f0054">Figs. 52 and 53</figref> which are pictorial illustrations of housing element 510 and to <figref idref="f0055">Figs. 54A and 54B</figref> which are sectional illustrations thereof. As seen in <figref idref="f0053 f0054 f0055">Figs. 51 - 54B</figref>, tubular portion 512 of housing element 510 is generally cylindrical, arranged about an axis 522, and has side ports 514, 516 and 518 extending in different directions therefrom, typically separated by 90 degrees about axis 522. Port 514 is preferably a male port which preferably meets luer standard ISO 594-1, while port 516 incorporates a normally closed swabbable valve which is configured to receive a male luer and port 518 is preferably a female port, which preferably meets luer standard ISO 594-1. Conventional plugs, nuts and covers may be used in association with ports 514 and 518.

0096Port 516 of housing element 510 includes a valve employing an elastomeric element 523, held in place by a cap 524, which is welded or otherwise fixed to housing element 510. Elastomeric element 523 and cap 524 are commercially available from Halkey-Roberts Corporation of St. Petersburg, Florida, USA and described in one or more of <patcit id="pcit0018" dnum="US6651956B"><text>U.S. Patents 6,651,956</text></patcit>; <patcit id="pcit0019" dnum="US6089541A"><text>6,089,541</text></patcit> and <patcit id="pcit0020" dnum="US6036171A"><text>6,036,171</text></patcit>. Alternatively, valves and valve elements commercially available from other sources such as Becton-Dickinson, Cardinal, Medegen and Filtertek may be employed.

0097Tubular portion 512 includes a central bore 525 having a slightly conical configuration, which is formed with a circumferential undercut 526. Between bore 525 and elastomeric element 523, port 516 is bifurcated by a fluid flow guide 527. Port 516 defines an internal volume 528.

0098Reference is now made to <figref idref="f0056 f0057 f0058">Figs. 55A - 58B</figref>, which illustrate handle element 520. As seen in <figref idref="f0056 f0057 f0058">Figs. 55A - 58B</figref>, the handle element includes a shaft portion 530, which is integrally formed with a top portion 532 from which extends a finger-engageable protrusion 534. It is appreciated that any other suitable general configuration of the top portion of the handle element may alternatively be employed.

0099Shaft portion 530 is generally symmetrical about a shaft axis 542 and has a slightly conical outer surface 544, typically having an angle α (as seen particularly in <figref idref="f0057">Fig. 56A</figref>) of 3 - 4 degrees, which corresponds to the slightly conical configuration of central bore 525 for rotatable sealing engagement therewith. As seen particularly in <figref idref="f0058">Figs. 58A and 58B</figref>, shaft portion 530 is typically formed with mutually sealed top and bottom cylindrical recesses 546 and 548, which are sealingly separated by a divider 550.

0100Disposed generally between recesses 546 and 548 and sealed therefrom is a partially peripherally-extending recess 552, selectably defining a fluid flow passageway between selectable ones of side ports 514, 516 and 518 depending on the rotational orientation of the handle element 520 relative to the housing element 510. Preferably extending radially and partially bifurcating the recess 552 is a fluid flow guide 554, which directs the flow of liquid between ports 514 and 518 through the passageway defined by recess 552 into the internal volume 528 of port 516 for flushing thereof, when the handle element 520 is suitably positioned. The radially outward facing edge 556 of fluid flow guide 554 is formed with a suitably tapered configuration in order to prevent liquid flow therepast when fluid flow guide 554 is not located opposite a port as shown in <figref idref="f0056">Fig. 55A</figref>, alternatively it may have many other shapes.

0101Reference is now made to <figref idref="f0059">Figs. 59A, 59B</figref>, <figref idref="f0060">59C and 59D</figref>, which are simplified pictorial illustrations of the stopcock of <figref idref="f0053">Fig. 51</figref> in four operative orientations and to <figref idref="f0061">Figs. 60A, 60B</figref>, <figref idref="f0062">60C and 60D</figref>, which are sectional illustrations of the stopcock of <figref idref="f0059">Figs. 59A, 59B</figref>, <figref idref="f0060">59C and 59D</figref>, respectively.

0102<figref idref="f0059">Figs. 59A</figref> and <figref idref="f0061">60A</figref> illustrate a first operating position of the stopcock of <figref idref="f0053">Fig. 51</figref>. As seen, there is no fluid communication between any of the ports. Liquid does not flow from port 518 to port 514, because it is blocked by fluid flow guide 554, whose edge 556 sealingly engages an inner facing wall 557 of bore 525 of housing element 510. This orientation may be utilized to close all three ports.

0103The operative orientation shown in <figref idref="f0059">Figs. 59A</figref> and <figref idref="f0061">60A</figref> may be advantageously employed when it is desired to prevent all flow of liquid through the stopcock. The procedure currently used requires careful placement of the handle to an angle 45 degrees from one of the ports. Such a procedure is unreliable and requires careful attention of the operator, which may be a doctor or a nurse in the middle of a surgery.

0104<figref idref="f0059">Figs. 59B</figref> and <figref idref="f0061">60B</figref> illustrate a second operating position of the stopcock of <figref idref="f0053">Fig. 51</figref>, which is typically employed for drawing blood or other fluids from the patient. The user typically connects a syringe to port 516 and draws blood from the patient through port 514 and partially peripherally-extending recess 552 through port 516 to the syringe, as indicated by an arrow 562. It is appreciated that this operating position may also be used for supplying a medicament to the patient when port 518 is closed, in a flow direction opposite to that indicated by arrow 562.

0105<figref idref="f0060">Figs. 59C</figref> and <figref idref="f0062">60C</figref> illustrate a third operating position of the stopcock of <figref idref="f0053">Fig. 51</figref>, which is typically employed for supplying a liquid to the patient from port 518 to port 514. Liquid flows via port 518 and partially peripherally-extending recess 552, along fluid flow guides 554 and 527, and into the internal volume 528 of port 516 as well as an internal volume 566 of the elastomeric element 523, flushing residual liquid therefrom, via port 514 to the patient, as indicated by an arrow 564.

0106It is a particular feature of the present invention that the provision of fluid flow guides 554 and 527 generally overcomes problems of the presence of residual liquids remaining in the internal volume 528 of port 516 as well as in internal volume 566 of the elastomeric element 523. This is important in various therapeutic situations. For example when blood is drawn from the patient through port 516, there remains residual blood in the internal volume 528 of port 516 and the internal volume 566 of the elastomeric element 523. This blood, if left in internal volumes 528 and 566 for a period of time, can clot and thus become dangerous if delivered to the patient. In addition, the coagulated blood could occlude the liquid passageway extending through port 516. Various infections could possibly arise as a result of the retained blood.

0107This feature is also useful when a medicament is supplied to a patient through port 516. If a portion of the medicament remains in the internal volumes 528 of port 516 and 566 of the elastomeric element 523, the dosage of the medicament that the patient receives is less than the intended dosage by an amount which cannot be readily ascertained. In addition, this residual medicament might be inadvertently supplied to the patient during a subsequent use of the stopcock, which could cause harm to the patient.

0108The present invention provides for automatic flushing of the liquid, such as blood or medicament from the internal volumes 528 and 566 and typically returning it to the patient without requiring the use of extra syringes and the opening of the medical set to the atmosphere, thereby increasing the chance of contamination.

0109<figref idref="f0060">Figs. 59D</figref> and <figref idref="f0062">60D</figref> illustrate a fourth operating position of the stopcock of <figref idref="f0053">Fig. 51</figref>, which may be used for flushing the IV set upstream of the stopcock, when port 516 is open to the atmosphere as by insertion of a male luer connector, such as a syringe tip (not shown), into the elastomeric element 523 of the valve thereof. The insertion of the male luer connector activates the flow of liquid from port 518, around fluid flow guide 554 and through partially peripherally-extending recess 552, to the male luer connector via the elastomeric element 523 of port 516, as indicated by an arrow 565. Alternatively, this operating position may be employed for pushing liquid via the side port 516, through port 518, in a direction opposite arrow 565, for uses such as mixing liquid in the pressure bag.

0110Reference is now made to <figref idref="f0063">Figs. 61A</figref>, <figref idref="f0064">61B</figref> and <figref idref="f0065">61C</figref>, which are simplified pictorial illustrations of an arterial monitoring set constructed and operative in accordance with a preferred embodiment of the present invention in various operative orientations. The arterial monitoring set includes a fluid-filled bag 612 and a tube portion 614 leading to a patient's artery. An arterial pressure sensor 616, which is schematically depicted in drawings 61A-61C, is coupled in a series along tube portion 614 and provides a visible output on a conventional monitor 618. Downstream of arterial pressure sensor 616 there is provided a stopcock 620 of the type described hereinabove with reference to any of <figref idref="f0013 f0014 f0015 f0016 f0017 f0018 f0019 f0020 f0021 f0022 f0023 f0024 f0025 f0026 f0027 f0028 f0029 f0030 f0031 f0032 f0033 f0034 f0035 f0036 f0037 f0038 f0039 f0040 f0041 f0042 f0043 f0044 f0045 f0046 f0047 f0048 f0049 f0050 f0051 f0052 f0053 f0054 f0055 f0056 f0057 f0058 f0059 f0060 f0061 f0062">Figs. 11 - 60D</figref>, including a swabbable valve 622 having an elastomeric element 623.

0111<figref idref="f0063">Fig. 61A</figref> shows the stopcock in an operative orientation such as that shown in <figref idref="f0019">Figs. 19A</figref> and <figref idref="f0021">20A</figref>, <figref idref="f0029">Figs. 29A</figref> and <figref idref="f0031">30A</figref>, <figref idref="f0039">Figs. 39A</figref> and <figref idref="f0041">40A</figref>, <figref idref="f0049">Figs. 49A</figref> and <figref idref="f0051">50A</figref> and <figref idref="f0059">Figs. 59A</figref> and <figref idref="f0061">60A</figref>. As shown in <figref idref="f0019">Figs. 19A</figref>, <figref idref="f0021">20A</figref>, <figref idref="f0039">39A</figref> and <figref idref="f0041">40A</figref>, a liquid passes through the arterial set, including stopcock 620, from the bag 612 to the artery of the patient. Alternatively, as shown in the stopcocks illustrated in <figref idref="f0029">Figs. 29A</figref>, <figref idref="f0031">30A</figref>, <figref idref="f0049">49A</figref>, <figref idref="f0051">50A</figref>, <figref idref="f0059">59A</figref> and <figref idref="f0061">60A</figref>, this operative orientation may be utilized when a medical procedure requires a cessation of the flow of liquid in the arterial set.

0112<figref idref="f0064">Fig. 61B</figref> shows the stopcock in an operative orientation such as that shown in <figref idref="f0019">Figs. 19B</figref> and <figref idref="f0021">20B</figref>, <figref idref="f0029">Figs. 29B</figref> and <figref idref="f0031">30B</figref>, <figref idref="f0039">Figs. 39B</figref> and <figref idref="f0041">40B</figref>, <figref idref="f0049">Figs. 49B</figref> and <figref idref="f0051">50B</figref> and <figref idref="f0059">Figs. 59B</figref> and <figref idref="f0061">60B</figref>, which is typically employed for drawing blood or other fluids from the patient, by employing a syringe 624 coupled to the swabbable valve 622. It is appreciated that this operating position may also be used for supplying medicament to the patient via syringe 624.

0113<figref idref="f0065">Fig. 61C</figref> shows the stopcock in an operative orientation such as that shown, for example in <figref idref="f0020">Figs. 19C</figref> and <figref idref="f0022">20C</figref>, <figref idref="f0030">Figs. 29C</figref> and <figref idref="f0032">30C</figref>, <figref idref="f0040">Figs. 39C</figref> and <figref idref="f0042">40C</figref>, <figref idref="f0050">Figs. 49C</figref> and <figref idref="f0052">50C</figref> and <figref idref="f0060">Figs. 59C</figref> and <figref idref="f0062">60C</figref>, which is typically employed for supplying a liquid to the patient from the arterial set. Liquid flows through the stopcock and flushes the internal volume of the swabbable valve and of the port in which it is located, flushing residual liquid therefrom to the patient.

0114Because it enables an operator to easily draw blood without exposing the arterial line to the atmosphere, use of a stopcock shown in any of <figref idref="f0013 f0014 f0015 f0016 f0017 f0018 f0019 f0020 f0021 f0022 f0023 f0024 f0025 f0026 f0027 f0028 f0029 f0030 f0031 f0032 f0033 f0034 f0035 f0036 f0037 f0038 f0039 f0040 f0041 f0042 f0043 f0044 f0045 f0046 f0047 f0048 f0049 f0050 f0051 f0052 f0053 f0054 f0055 f0056 f0057 f0058 f0059 f0060 f0061 f0062">Figs. 11 - 60D</figref> in a monitoring set reduces both the risk of contamination and the need for extra covers or plugs.

0115For routine use in arterial lines, the stopcock is employed in a position such as that shown in <figref idref="f0019">Figs. 19A</figref>, <figref idref="f0021">20A</figref>, <figref idref="f0039">39A</figref>, <figref idref="f0041">40A</figref> and <figref idref="f0063">61A</figref>, where the fluid flows from the arterial line to the patient without making contact with the elastomeric element 623 of the valve 622.

0116To draw blood from the patient, the operator places the handle of the stopcock in the operative orientation shown in <figref idref="f0019">Figs. 19B</figref>, <figref idref="f0021">20B</figref>, <figref idref="f0029">29B</figref>, <figref idref="f0031">30B</figref>, <figref idref="f0039">39B</figref>, <figref idref="f0041">40B</figref>, <figref idref="f0049">49B</figref>, <figref idref="f0051">50B</figref>, <figref idref="f0059">59B</figref>, <figref idref="f0061">60B</figref> and <figref idref="f0064">61B</figref>, introduces a syringe to the valve, thereby opening it, and draws blood.

0117After blood is drawn, residual blood remains in the internal volumes of the valve and the side port of the stopcock. This residual blood, if not removed from the stopcock, may cause damage to the patient as discussed hereinabove with reference to drawings 9C, 19C, 20C, 29C, 30C, 39C, 40C, 49C, 50C, 59C and 60C.

0118In order to clear the residual blood from the internal volumes, the operator places the handle of the stopcock in the operative orientation shown in <figref idref="f0020">Figs. 19C</figref>, <figref idref="f0022">20C</figref>, <figref idref="f0030">29C</figref>, <figref idref="f0032">30C</figref>, <figref idref="f0040">39C</figref>, <figref idref="f0042">40C</figref>, <figref idref="f0050">49C</figref>, <figref idref="f0052">50C</figref>, <figref idref="f0060">59C</figref>, <figref idref="f0062">60C</figref> and <figref idref="f0065">61C</figref>. In this orientation, the flow of liquid in the arterial line flushes the internal volumes of both the valve and the side port of the stopcock and clears the residual blood therefrom.

0119For use of the stopcock in monitoring the arterial blood pressure of the patient, the flow of liquid must not come in contact with the elastomeric component of the valve. Therefore, when the operator has removed the residual blood from the internal volumes of the valve and the side port of the stopcock, he would again place the handle of the stopcock in the operative orientation seen in <figref idref="f0063">Fig. 61A</figref>.

0120It is appreciated that the stopcock structure shown and described hereinabove may have many advantageous uses in addition to those described specifically hereinabove.

0121It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove as well as modifications and variations thereof as would occur to a person of skill in the art upon reading the foregoing specification and which are not in the prior art.