Abstract:
An intravenous infusion device incorporates a valve which controls the intravenous fluid drip rate. First and second drip chambers are provided in which one drip chamber contains a macro drip nozzle and the other drip chamber contains a micro drip nozzle. The valve is selectable between a first position that connects an intravenous fluid bag to the macro drip nozzle and a second position that connects the fluid bag to the micro drip nozzle.

Description:
CROSS-REFERENCE TO RELATED APPLICATION  
       [0001]     The present application is a continuation of U.S. patent application Ser. No. 11/551,944, filed Oct. 23, 2006, which claims the benefit of U.S. Provisional Application Ser. No. 60/729,139 filed on Oct. 21, 2006, which is hereby incorporated by reference in its entirety. 
     
    
     BACKGROUND  
       [0002]     The initial treatment for accident victims or emergency room patients often require rapid infusion of intravenous (IV) medication or other treatment-dependent fluids in order to stabilize the patient following a trauma or other serious condition. Once the patient becomes stable, however, the IV infusion rate may be desired to be reduced. It is inefficient and often difficult to replace a rapid IV infusion set with a different IV set having a slower or more normal infusion rate for stable or longer-term use with a particular patient.  
       SUMMARY  
       [0003]     In one embodiment of the disclosure, an IV infusion apparatus incorporates two drip chambers associated with different drip volume rate nozzles. One nozzle and drip chamber is designed to deliver a rapid infusion rate drip, while the other nozzle and drip chamber is designed to deliver a slower infusion rate drip. A unique switchable valve arrangement allows the infusion rate to be chosen to serve the needs of a patient at any given time.  
     
    
     DESCRIPTION OF THE DRAWING  
       [0004]      FIG. 1  is a perspective view of an intravenous infusion set in accordance with an embodiment of the disclosure.  
         [0005]      FIG. 2  is a front elevational view of a valve assembly incorporated as part of the infusion set shown in  FIG. 1 .  
         [0006]      FIG. 3  is a side elevational view of the valve assembly shown in  FIG. 2 .  
         [0007]      FIG. 4  is a top plan view of the portion of the valve assembly shown in  FIG. 2 .  
         [0008]      FIG. 5  is a front elevational cross-sectional view of a valve assembly such as that shown in  FIG. 2 , taken along line  5 - 5 .  
     
    
     DETAILED DESCRIPTION  
       [0009]     Referring to  FIG. 1 , there is shown an intravenous (IV) infusion set or apparatus  10 , as will be described, which is designed to administer fluids from a fluid container, such as an IV bag  12 , to a patient&#39;s vascular system through a needle or catheter inserted into a vein for use typically under gravity conditions. Infusion device or apparatus  10  is shown as incorporating a male luer or connector  14  protected by cap  16 . Connector  14  is designed to connect to a female luer or connector (not shown) which is associated with or connected to the needle or catheter (also not shown) that would be inserted into a patient&#39;s vein. Coupled to connector  14  is tubing  18  which illustratively is shown as including Y-site  20 , and Y-connector  22 . Y-site  20  provides a location at which additional medications or drugs may be administered by syringe, for example, into tubing  18  for delivery to the patient. A pinch clamp  24  and a roller clamp  26  are also shown as illustratively being located along or coupled to tubing  18 .  
         [0010]     In accordance with an aspect of the disclosure, an infusion rate apparatus  28  comprises drip chambers  30  and  32 . The exit  34  of drip chamber  30  is coupled via tubing  36  to one branch of Y-connector  22 . The exit  38  of drip chamber  32  is coupled via tubing  40  to the other branch of Y-connector  22 . A pinch claim  42  is illustratively shown in place along tubing  40 . A valve assembly  44  is positioned in the vicinity of the upper ends of drip chambers  30  and  32 . A connector  46  extends upwardly from valve assembly  44  and, as shown more clearly in  FIGS. 2 and 5 , incorporates a pointed end or spike  48  which is able to pierce the fluid delivery outlet seal  50  of IV bag  12 .  
         [0011]     As can be seen in  FIGS. 2-5 , valve assembly  44  comprises a housing  52  from which connector  46  extends. Housing  44  encloses a selector  54  which slides within housing  52 . Selector  54  is illustratively shown as being made of two pieces, but other forms of construction are also possible. O-rings  56  and  58 , illustratively constructed of silicone rubber or other suitable material, are shown positioned between selector  54  and housing  52  in order to maintain a fluid-tight seal such that selector  54  operates as a valve piston. O-rings  56  and  58  prevent fluid from entering into the drip chamber that is not being used at the time and they also prevent the fluid from leaking to the outside of the valve assembly  44 . The sliding position of selector  54  is chosen to couple connector  46  (which is operatively located within the interior of IV bag  12  as shown in  FIG. 1 ) to either drip chamber  30  or  32 . An intermediate position may be permitted that couples connector  46  to both drip chambers as a non-operative “purge” position. In operation, however, selector  54  will either be slidingly moved to contact either end portion  60  or end portion  62  of selector  54  with housing  52 , thus stopping the movement of selector  54  in one operating position or the other. In the position in which connector  46  is coupled to drip chamber  30 , fluid from IV bag or reservoir  12  flows into drip chamber  30  through a drip volume rate nozzle  64 , thereafter flowing from drip chamber  30  via exit  34 . In the position in which connector  46  is coupled to drip chamber  32 , fluid from IV bag or reservoir  12  flows into drip chamber  32  through a drip volume rate nozzle  66 , thereafter flowing from drip chamber  32  via exit  38 . Infusion apparatus  10  therefore offers a flow rate selection which allows for the choice of one of two flow volume rates. In the illustrative, non-limiting embodiment shown, flow rates of 10 drops/ml flow volume via drip rate nozzle  66  (designated as macro flow) and 60 drops/ml flow volume via drip rate nozzle  64  (designated as micro flow) are provided by device  10  through the operation of valve assembly  44 . Selector slide  54  may be labeled by indicia  68  with the appropriate flow rate, e.g., as in the illustrated embodiment, with a numeral “ 60 ” and a numeral “ 10 ” along with adjacent, associated arrows indicating the proper direction to push or slide selector  54 .  
         [0012]     Housing  52  and selector  54  are illustratively shown as being constructed of an ABS material. O-rings  56  and  58 , as described above, may be constructed of an FDA-approved silicone material, for example. As illustrative examples only, parts of apparatus  10  may be constructed of the materials as follows, but other suitable materials having the desired operational characteristics may also be effectively used. For example, housing  52  may be constructed of Lustran 348 ABS, O-Rings  56  and  58  may be made of 5568A 010 Silicone, drip chambers  32  and  34  may be constructed of PVC AM88, tubing  18  may be made of PVC Clearflo 6811-02, Y-site  20  may be constructed of ABS Terlux 2802TR, and male luer  14  may be made of Acrylic, such as Perspex CP927G. In the illustrative example of infusion apparatus  10 , there are no non-bonded connectors. All bonded connections perform at greater than 15 psi. All connector sites are UV bonded to prevent leakage. The rate that the fluid passes through tubing  18  is controlled by roller clamp  26 . The maximum volume rate for apparatus  10  is illustratively 10 drops/ml, while the minimum volume is zero drops/ml (i.e., when fluid flow through apparatus  10  is operatively turned off.  
         [0013]     The embodiment of intravenous infusion set or apparatus  10  shown in  FIG. 1  is illustratively shown as a disposable, single-use device intended for use under gravity conditions, although other modes of operation and use may be employed as well. Apparatus  10  is intended to be packaged as a sterile item, with sterilization being illustratively performed via exposure to gamma radiation.  
         [0014]     The following steps describe one way in which apparatus  10  may be used in connection with the administration of an intravenous solution to a patient. Other steps may be added or used in place of particular described steps as desired in individual applications or situations.  
         [0015]     1. Open package (not shown) and remove sterile apparatus  10 .  
         [0016]     2. Remove end protector  70  from spike  48  and insert spike  48  fully into outlet seal  50  of solution container  12 .  
         [0017]     3. Verify that the selector  54  is in its center, or “purge,” position.  
         [0018]     4. Gently squeeze and release macro and micro drip chambers  30  and  32  until half filled. Do not overfill chambers. Allow solution to clear all air in tubing  18 ,  36 , and  40 .  
         [0019]     5. Remove the end cap  16  and attach the male luer  14  to the patient&#39;s needle or catheter (not shown).  
         [0020]     6. Choose the desired flow rate, either the 60 drip/ml micro flow, or the 10 drip/ml macro flow, depending upon patient conditions.  
         [0021]     7. Position selector  54  to the desired flow volume position. If 60 drips/ml is desired, push the selector slide in the direction as indicated by its corresponding indicia  68 , e.g., the appropriate arrow. If 10 drips/ml is desired, push the selector/slide in the direction as indicated by its corresponding arrow.  
         [0022]     8. If 60 drips/ml is chosen and selected, close the pinch clamp  42  located directly below the 10 drip/ml drip chamber  32 . This pinch clamp  42  must be reopened if the flow is switched back to the 10 drips/ml flow rate setting.  
         [0023]     9. Adjust the fluid flow drip rate by using the roller clamp  26 . When a faster drip rate is desired, slowly open the roller clamp  26 . When a slower drip rate is desired, slowly close the roller clamp  26 .  
         [0024]     10. Compatible medication can be injected through Y-site  20 , for example.