Abstract:
A drip chamber includes an elongated transparent container, and a cap. The container has open proximal and distal ends. The cap covers the distal end and further includes a drip forming tube, a cannula and an attachment element used to removably attach the chamber to a connector. The cannula extends distally away from the chamber and is surrounded by the attachment element. A pathway for fluid is established through the cannula and into the chamber.

Description:
RELATED APPLICATION 
     This is a continuation, of prior application Ser. No. 09/041,566, filed Mar. 12, 1998, now U.S. Pat. No. 6,206,860, issued Mar. 27, 2001, which is hereby incorporated herein by reference in its entirety. 
     The present application is a Continuation-In-Part of and claims priority from the following co-pending U.S. Pat. applications: 
     U.S. Pat. No. 5,848,994, for an invention entitled “IV Sets With Needleless/Spikeless Fittings And Valves”, issued Dec. 15, 1998, which in turn claims priority from U.S. Pat. No. 5,645,538, filed on Mar. 12, 1996 for an invention entitled “Needleless Valve For Use In Intravenous Infusion”, which in turn claims priority from U.S. Pat. No. 5,405,333 filed on Sep. 16, 1993 for an invention entitled “Liquid Medicament Bag With Needleless Connector Fitting Using Boat Assembly.” 
     Additionally, this application claims priority from U.S. Pat. No. 5,735,826, for an invention entitled “Drip Chamber With Female Luer Fitting” issued Apr. 7, 1998, which in turn claimed priority from Ser. No. 08/377,514 for an invention entitled “Drip Chamber With Female Luer Fitting” filed Jan. 24, 1995, abandoned which in turn is a divisional application of issued U.S. Pat. No. 5,445,623, issued on Aug. 29, 1995 for an invention entitled “Drip Chamber With Luer Fitting”. All are incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to intravenous (IV) liquid medicament infusion equipment, and more particularly to drip chambers, valves and attachment mechanisms. 
     BACKGROUND OF THE INVENTION 
     One of the most widely used methods of medical therapy is the intravenous (IV) infusion of liquid medicaments and/or nutrients into the bloodstream of a patient. A familiar apparatus that is used in many IV infusion applications is an IV container, such as an IV bag or bottle, which contains the liquid to be infused into the patient. 
     When the IV container is a bag, or bottle, a rigid, hollow, sharpened IV spike is pushed into the container to establish a pathway for fluid communication through which the liquid can flow out of the container. The spike, in turn, is connected to or formed integrally with an inlet port of a small, elongated, transparent hollow container familiarly referred to as a “drip chamber”, with the fluid pathway of the spike in fluid communication with the inlet port of the drip chamber. 
     Additionally, an IV line is connected to the bottom or proximal end of the drip chamber. Preferably, a means for controlling the flow (a roller clamp, pump, or other suitable flow regulating device) is engaged with the IV line, and a medical technician can manipulate the flow controlling means and thereby regulate fluid flow through the IV line. To complete the path for fluid communication from the IV container to the patient, a sharp needle is connected to the IV line to puncture the patient. 
     Usually, the container is elevated above the patient to establish a positive pressure head to force the fluid that is within the container through the drip chamber into the patient. Because the drip chamber is transparent, a medical technician can view the medicament as it passes (normally by dripping) through the drip chamber to aid the medical technician in establishing a predetermined flow rate of medicament into the patient as the medical technician adjusts the flow controlling means on the IV line. 
     While effective as aiding in the establishment of a predetermined fluid flow to the patient, existing drip chambers, as noted above, require the use of sharpened spikes to puncture the IV container containing the liquid. This is undesirable, particularly in the era of AIDS, because spikes, like other sharps instruments, can inadvertently puncture the bag or medical technician who is manipulating the spike and thereby potentially contaminate the bag contents or infect the technician with AIDS or other disease. Thus, as recognized by the present invention, it is desirable to avoid the use of sharp instruments whenever possible, while preserving the quick connection such instruments provide. 
     Further, it is desirable to connect and disconnect the drip chamber or other components in the IV system without spillage of medicament. As recognized by the present invention, such reduction in spillage can be obtained through the use of reflex valves which are compatible with spikeless drip chambers and other needleless IV components. 
     Accordingly, it is an object of the present invention to provide a valve apparatus in an IV drip chamber or other IV component for engaging a complementary fitting, without the need to use a sharp connector. Another object of the present invention is to allow connection and disconnection of components without the spillage of medicament. Yet another object of the present invention to provide a drip chamber which is easy to use and cost-effective to manufacture. 
     SUMMARY OF THE INVENTION 
     A drip chamber includes an elongated transparent container defining an elongated hollow chamber. The container has both a proximal end and a distal end. A cap covers the distal end of the container, and it includes a drip-forming tube, a cannula and an attachment element. The drip forming tube is disposed within the container while the cannula extends distally away from the tube and establishes a pathway for fluid communication between a IV medicament container and the drip chamber. The attachment element surrounds the cannula and is configured so as to removably engage the chamber with a connector. 
     In one presently preferred embodiment, the proximal end of the drip chamber is engageable with an IV tube and connector to establish a pathway for fluid communication between the drip chamber and a patient. 
     The cannula in the presently preferred embodiment, is metal, but the present invention recognizes that it may be formed from other materials such as plastic. 
     In another embodiment, the proximal end of the container is a solvent bondable port element in fluid communication with the chamber. In yet another embodiment, the proximal end of the container is also configurable as a luer fitting. The present invention recognizes that either a male or female luer fitting may be used in this embodiment. 
     On the distal side of the container, to retain the chamber with an IV medicament connector, an attachment element is used. In one embodiment, the attachment element is configured as a threaded collar fitting. In another embodiment, the attachment element is configured as a so called “A” clamp. The “A” clamp has an open and a normal retention configuration, and is biased to the normal configuration. Preferably, the clamp includes two clamp elements, two fulcrum bars and two retaining lips. More clamp elements, fulcrum bars and lips are possible, but two of each is the most efficient. Specifically then, the clamp elements each have a distal pincer end and a proximal squeezeable end. The fulcrum bars are then attached on one side to the clamp element and on the opposite side to the cannula element or cannula holding element. The fulcrum bars are long enough such that the distal pincer ends are separated when the clamp is in the normal configuration. Ideally, the pincer ends open to facilitate easy assembly of the connector. The distal pincer ends may also configured with a lip to engage a complementary surface on the connector. The connector can be the port of any IV device, but the port of an IV bag, or other source of fluid, is preferable. To further facilitate engagement of the “A” clamp, the lips include an angular surface which, when urged against the connector port, move the pincer ends open sufficiently to allow mating of the lip and the complementary connector surface. 
     In another embodiment, a drip chamber includes an elongated container defining a hollow chamber. The chamber has both a proximal end and a distal end. A cap preferably covers the distal end of the container and it includes a drip forming tube, a valve body, at least one valve member disposed in the valve body and a valve actuating element. The drip forming tube is disposed within the container while the valve body defines a pathway for fluid communication through the cap. The valve member is disposed in the body and is biased to a first configuration where the path for fluid communication is not established. That is, in the first configuration, fluid may not pass through the body. Additionally, the valve member is movable to a second configuration where fluid communication through the body is permitted. Also disposed in the valve body is the valve actuating element. This element defines at least one engagement surface for contacting a mating element. Contact with the mating element causes the valve actuating element to move against the valve member. This pressure causes the valve member to move to the second configuration. 
     A variation of the above includes a valve member defining an outer periphery that is interrupted at least once within the periphery. The interruption within the periphery allows the fluid to pass directly through the member when in the second configuration rather than around the member (although the fluid could also pass through and around the member as envisioned above). In other words, when the valve member is in the second configuration, the interruption within the periphery defines an opening in the valve member allowing fluid through the valve member and thus, through the body. 
     The proximal end of the drip chamber may be configured in a variety of ways. In one embodiment the proximal end is configured as a male luer fitting. In another the proximal end is configured with a solvent bonded IV tube. And in yet another the proximal end is configured as a female luer fitting. 
     In another preferred embodiment, an IV component connector includes a valve body, a valve member and a valve element. In this embodiment, the valve body has a distal and a proximal end which define a path providing fluid communication through the body. The distal end has an attachment element to engage a complementarily shaped connector or surface. The proximal end has an outlet providing fluid communication with a connected component. 
     The valve member in this embodiment is disposed in the body and defines an outer periphery that is interrupted within the periphery at least once. The valve member is biased to a first configuration where the path for fluid communication is not established through the body. Also, the member is movable to a second configuration where fluid communication is permitted. The valve element is also disposed in the body and defines at least one engagement surface distally beyond the body. This surface contacts a mating element from another component that causes the valve element to move against the valve member thus moving the valve member to the second configuration. 
     In one presently preferred embodiment, the attachment element is configured as a male luer fitting to removably engage a female luer connector. 
     In another variation, the component connected to the proximal end may be any of various other IV components as disclosed in U.S. Pat. No. 5,645,538 to Richmond and incorporated herein by reference. Particular attention is directed to FIGS. 13, 15, 18, 19, 22-30; and the Specification, column 2, lines 14-18. 
     These and other aspects of the present invention can best be appreciated in reference to the accompanying drawings in which like numerals refer to like parts, and in which: 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a cross-sectional view of a valve of the present invention showing a male cannula fitting drip chamber combined with an “A” clamp; 
     FIG. 2 is a cross-sectional view of an alternate inserted male cannula fitting drip chamber combined with an “A” clamp; 
     FIG. 3 is a cross-sectional view of a drip chamber with an embedded cannula fitting combined with a threaded collar fitting; 
     FIG. 4 is a cross-sectional view of a drip chamber with a cannula combined with a threaded collar fitting; 
     FIG. 5 is a cross-sectional view of one embodiment of the IV component connector; 
     FIG. 6 is a cross-sectional view of another embodiment of the IV component connector; 
     FIG. 7 is a cross-sectional view of yet another embodiment of the IV component connector; 
     FIG. 8 is a cross-sectional view of the connector as shown in FIG. 5 combined with a drip chamber and a proximal end configured as a male luer fitting; 
     FIG. 9 is a cross-sectional view of the connector as shown in FIG. 6 combined with a drip chamber and a proximal end configured as a solvent bonded IV tube; 
     FIG. 10 is a cross-sectional view of the connector as shown in FIG. 7 combined with a drip chamber and a proximal end configured as a female luer fitting. 
     FIG. 11 is a partial cross-sectional view of an IV set of the present invention, showing various drip chamber upper connections and various drip chamber lower connections in exploded relationships. 
     FIG. 12 is a cross-sectional view of a male reflux valve bonded to a “T”-site connector. 
     FIG. 13 is a cross-sectional view of a male reflux valve bonded to a “Y”-site connector. 
     FIG. 14 is a plan cross-sectional view of a plurality of reflux valves operably engaged with a stopcock. 
     FIG. 15 is an exploded cross-sectional view of various reflux valves in combination with a filter assembly. 
     FIG. 16 is an exploded isometric view of a four-way valve with various associated components including Luer flags with reflux valves. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring initially to FIG. 1, the drip chamber with cannula of the present invention is shown and is generally designated as  10 . Preferably, the drip chamber  10  is made of a plastic (e.g. polypropylene, polyethylene, etc.). As shown, the drip chamber  10  has a distal end  12  which can be engaged with a source of fluid, such as an IV container (not shown). It is to be understood that the source of fluid can be any container suitable for holding fluid medicaments, e.g., the source can be an IV bag, vial, IV bottle, semi-rigid container, syringe, etc. 
     As further shown in FIG. 1, the drip chamber  10  has a proximal end  14  that can be engaged with an IV tube (shown as  39  in FIG.  2 ). Specifically, the IV tube  28  is advanced onto the proximal end  14  of the drip chamber  10  and is held on the proximal end  14  by solvent bonding, rf sealing, ultrasonic welding techniques, or other techniques known by those skilled in the arts. 
     Still referring to FIG. 1, the drip chamber  10  includes a hollow transparent glass or plastic container  16 , and the container  16  defines a hollow chamber  18 . As shown, the distal end  12  is configured as a cap including a drip forming tube  20 , a cannula  22  formed integrally with a cannula holding element  24  and an attaching mechanism generally designated  26 . 
     Cross referencing FIGS. 1 and 2, the attaching mechanism  26  is an “A” clamp. As shown, the “A” clamp consists of two clamp elements  28   a,    28   b.  The clamp elements  28   a,    28   b  are attached to the cannula holding element  24  by two fulcrum bars  30   a,    30   b.  It can be noted now that the “A” clamp is biased to the retention configuration shown in the FIGS. The clamp elements  28   a,    28   b  each have a lip  32  on the distal pincer end to engage a ledge  34  on the fluid source connector port  36 . The lip  32  is configured with an angular surface  38  to facilitate engagement of the connector port  36 . The distal end of the clamp elements  28   a,    28   b  can have bumps  35   a,    35   b  to improve the operator&#39;s grip while applying pressure to the clamp elements  28   a,    28   b.  Squeezing pressure on the clamp elements  28   a,    28   b,  below the fulcrum bars  30   a,    30   b,  urges the clamp elements  28   a,    28   b,  to an open configuration. 
     FIG. 2 shows an alternate embodiment which is identical to FIG. 1 in all essential respects, except that the cannula  42  is embedded into the cannula holding element  24 . Additionally, FIG. 2 also shows the IV tube  39  inserted into the proximal end  14  of the drip chamber  10  and held in the proximal end  14  by solvent bonding, rf sealing, ultrasonic welding techniques, or other techniques known by those skilled in the arts. 
     FIG. 3 shows an alternate embodiment which is identical in all essential respects to FIG. 2 except that the attaching mechanism  26  is alternately configured as a threaded collar surrounding the embedded cannula  37 . 
     FIG. 4 shows an alternate embodiment which is identical in all essential respects to FIG. 1 except that the attachment mechanism  26  is configured as a threaded collar surrounding the integral cannula  22 . 
     Now referring to FIG. 5, an IV component connector is shown and generally designated as  40 . The connector  40  has a valve body  42  which has a distal end  44  and a proximal end  46 . The body defines a fluid passageway  48  which provides a pathway for fluid communication through the body  42 . As can be readily observed in FIG. 5, the distal end  44  is configured as a male fitting for connection to a corresponding female fitting (not shown). Fluid communication through the body  42  ends at the proximal end  46  where an outlet  50  is provided. The proximal end  46  attaches to various other IV components as disclosed in issued U.S. Pat. No. 5,645,538 to Richmond and incorporated herein by reference. 
     Still referring to FIG. 5, a valve member  52  is shown disposed in the body  42  to selectively block the fluid passageway  48 . The valve member  52  is preferably made from plastic, rubber, etc., and defines an outer periphery that may be interrupted by a fluid orifice  56 . Those skilled in the art will recognize that more than one fluid orifice  56  is possible and that the orifice  56  may be shaped in a variety of ways. When the valve is in place in a closed configuration, the orifice  56  is sealed and consequentially, a fluid tight seal between the valve member  52  and the interior surface of the body  42  is established. It is to be understood that the valve member  52  is biased to the closed configuration as shown in FIG. 5, wherein no fluid communication is permitted through the valve body  42  (and hence through the outlet  50 ). On the other hand, when pressure is exerted on the member  52  from the distal side  44  of the valve member  52 , the member  52  is moved to cause the fluid orifice  56  to open and, thus, to move the member  52  to the open configuration. 
     FIG. 5 additionally shows that a valve element  60  is reciprocably disposed in the fluid passageway  48 . The valve element  60  is formed with a lower probe  62 , a retention element  63  and an upper contact flange  64 . When the valve element  60  is urged into the valve body  42 , the lower probe  62  exerts pressure, thus opening the valve member  52  as discussed above. As shown, the retention element  63  retains the valve element  60  in the valve body  42  by contacting a surface  66 . 
     It can now be understood that the distal end  44 , configured as a male Luer fitting, can be engaged with a complementarily shaped female Luer fitting (not shown). This engagement causes the upper contact flange  64  of the valve element  60  to be contacted by the female Luer fitting (not shown) and to urge the valve element  60  into the valve body  42 . When the valve element  60  is urged sufficiently, it contacts the valve member  52  and urges the valve member  52  to the open configuration, thereby allowing fluid communication through the orifice  56 , and hence through the fluid passageway  48 . 
     Now referring to FIG. 6, an alternate embodiment of the IV component connector is shown. This is in all essential respects identical to FIG. 5, except that the valve element  60  has a skirt  65  for urging the valve member  52  downwardly and further urging the fluid orifice  56  to the open configuration. Also, as can best be seen in FIG. 6, the valve member  52  need not be rigidly attached to the valve body  42 . 
     FIG. 7 shows yet another alternative embodiment of the IV component connector of the present invention. This is in all essential respects identical to FIG. 5, except that the valve member  52  can also be held in place by trapping between the separate sub-components of the valve body  42 . This Figure also best illustrates an alternate valve member  52 . In this embodiment, the distal side of the valve member  52  is essentially flat while the proximal side bulges in the center. Said another way, the thickness of the valve member  52  increases towards the center. Importantly, because of the thickening of the valve member  52  towards the center on the proximal side of the valve member  52 , pressure from the proximal side  46  of the valve member  52  will cause the valve member  52  to close more tightly. That is, backflow pressure will act to close the valve member  52  and increased pressure will more tightly close the valve  52 . 
     FIGS. 8,  9  and  10  show the various embodiments of the component connector of the present invention in combination with drip chambers. FIG. 8 also shows the proximal end configured as a male luer fitting  70 . The male luer fitting  70  can then be connected and disconnected from a corresponding female fitting  72 . FIG. 9 shows the proximal end configured as a solvent bonded IV tube  74 . FIG. 10 shows the proximal end configured as a female luer fitting  76 . The female luer fitting  76  can then be connected and disconnected from a corresponding male fitting  78 . 
     Now referring to FIG. 11, an IV set is shown, generally designated  80 . As can be appreciated in reference to FIG. 11, the present IV set includes a drip chamber, an upper needleless connector on the top of the drip chamber to connect the top to a needleless fitting (such as any of those shown herein), an IV tube connected to the bottom of the drip chamber, a flow restrictor engaged with the IV tube, and a lower needleless connector connected to the end of the IV tube to connect the tube to a needleless fitting (such as any of those shown herein). 
     As shown in FIG. 11, the drip chamber can be an elongated hollow transparent plastic cylindrical drip chamber  82  or tapered drip chamber  84 . In any case, the present drip chamber is “elongated” in that its length is at least half again as great as its diameter. The IV tube is a hollow plastic IV tube known in the art, with the flow restrictor being an open slide clamp  86  having an open head end  88  (FIG.  11 ). 
     In the particular embodiment shown in FIG. 11, an IV tube  102  can be connected by attaching the tube  102  by means well-known known in the art to an exit port  104  of the cylindrical drip chamber  82  or to and exit port  106  of the tapered drip chamber  84 . For succinctness of disclosure, the discussion below will focus on the cylindrical drip chamber  82 , but it is to be understood that the discussion below is equally relevant to the tapered drip chamber  84  or indeed any well-known drip chamber. The open clamp  86  can be manipulated by means well-known in the art to constrict the IV tube  102  to stop fluid flow therethrough. 
     FIG. 12 shows a male member valve  208  which is disposed in a port  210  of a so-called “T”-site connector  202 . The T-site connector  202  defines a main fluid passageway  204  and a secondary fluid passageway  206 , and the male valve  198  can be manipulated as described above to selectively permit fluid communication through the secondary fluid passageway  206  of the T-site connector. 
     FIG. 13 shows a male member valve  208  which is disposed in a port  210  of a so-called “Y”-site connector  212 . As shown, the Y-site connector  212  defines a main cylindrical fluid passageway  214  and a secondary fluid passageway  216 . The valve  208  can be operated as disclosed above to selectively block fluid communication through the secondary passageway  216  of the Y-site connector  212 . 
     FIG. 14 shows an IV stopcock, generally designated  220 . In accordance with principles well known in the art, the stopcock  220  includes a central fluid passageway that is covered by a cover plate  222 , and an operating hand wheel  224 . Additionally, the stopcock  220  can include at least two ports, and can include additional ports. 
     As shown in FIG. 15, the IV component can be a tubular IV connector  290  having a filter  292  disposed athwart a fluid passageway  294  defined by the connector  290 . The connector  290  has an inlet port  296  and an outlet port  298 . The inlet port  296  can be selectively blocked by engaging the port  296  with any one of a female member valve  300 , a first male member valve  302 , or a second male member valve  304 . Similarly, the outlet port  298  can be selectively blocked by engaging the port  298  with any one of a female member valve  306 , a first male member valve  308 , or a second male member valve  310 . Accordingly, the IV component shown in FIG. 15 is resealable, in that upon disconnecting a fitting from the valve member in one of the ports  296 ,  298 , fluid flow through the component is prevented by the valve member in the disconnected port. 
     Now referring to FIG. 16, a novel multiport IV valve of the present invention, generally designated  674 , can be seen. As shown, the multiport valve  674  includes a first port  676  which is generally cylindrically shaped, and a second port  678  which is also generally cylindrically shaped and is configured as a female Luer fitting. As can be appreciated in reference to 
     FIG. 16, the first and second ports  676 ,  678  are coaxial and establish a main fluid passageway therebetween. A first male Luer valve  680  is fixedly engaged with the first port  676  for selectively blocking fluid communication therethrough. 
     FIG. 16 additionally shows that the multiport valve  674  includes third, fourth, fifth and sixth ports  682 ,  684 ,  686 ,  688 , all of which are generally cylindrically shaped. As shown, the third and fifth ports  682 ,  686  are coaxial with each other. Likewise, the fourth and sixth ports  684 ,  688  are coaxial with each other. Each of the third through sixth ports  682 ,  684 ,  686 ,  688  defines a respective fluid pathway, and fluid communication through the fluid pathway can be selectively established or otherwise effected as disclosed below. 
     For example, a female reflux valve  690  can be disposed in the third fluid port  682  for selectively establishing fluid communication through the port  682  and into the main fluid passageway  679  in accordance with principles disclosed previously. Moreover, a combination male reflux valve-check valve  692 ,  694 , can be disposed in the fourth fluid inlet port  684  of the multiport valve  674 . If desired, the male reflux valve  692  can be replaced with a female reflux valve (not shown) which is substantially identical to the female reflux valve  30  shown in FIG.  1 . 
     Additionally, fluid communication through the fifth inlet port  686  can be permanently blocked if desired by bonding a plug  696  within the port  686  by means well known in the art. Alternatively, the fifth fluid inlet port  686  can hold a fluid filter, e.g. a filter  698 . As shown, the falter  698  includes a filter element  700  having a membrane  702  through which air can pass. The filter  698  also includes a plug element  704  which engages filter element  700  and which holds the filter element  700  within the sixth fluid port  686 . 
     While the particular drip chamber with valve as herein shown and described in detail is fully capable of attaining the objects stated above, it is to be understood that it is but the presently preferred embodiments of the present invention, and that the scope of the present invention is accordingly to be limited by nothing other than the appended claims where singular nouns do not mean “one and only one,” but rather, “at least one” unless otherwise specifically noted as “one and only one.”