Abstract:
The present invention monitors an IV bag injection port and informs the user of prior injections. The present invention employs an object and/or a sealed chamber within a transparent IV fluid bag injection port. In the case of the object, notification of prior use is achieved when the object&#39;s or IV fluid&#39;s appearance is altered. With respect to the sealed chamber, the chamber&#39;s seal is breached to allow fluid to pass between the chamber and the IV bag to change the appearance of the contents of the chamber. Since the injection port and bag walls are at least partially transparent, medical personnel are able to observe the altered appearance of either the object, IV fluid or the sealed chamber.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
   This application claims priority from U.S. Provisional Patent Application Ser. No. 60/730,361, entitled “Method and Apparatus to Indicate Prior Use of a Medical Item” and filed Oct. 27, 2005, the disclosure of which is incorporated herein by reference in its entirety. 

   BACKGROUND OF THE INVENTION 
   1. Technical Field 
   The present invention pertains to a device for use with a medical item that notifies a user of prior medical item use. 
   2. Discussion of Related Art 
   Generally, an intravenous (IV) fluid bag is shipped in a sealed plastic covering to protect the bag. The IV bag is generally in the form of a sealed plastic container and includes two ports. The ports may be utilized to connect the bag to an administration set to deliver IV fluid from the bag to a patient and to receive syringe needles for injection of medicaments into the IV fluid for infusion to a patient. The syringe needles pierce a penetrable seal on the injection port where the medicaments are injected before the needle is removed. The penetrable seal includes a self-sealing material to prevent leakage when a syringe needle is removed, where the sealing material is of sufficient strength to withstand numerous injections without a leak. Utilizing such injection ports enables introduction of medicaments without compromising the sterility of the bag. 
   When medical personnel administer IV fluid to a patient, it is important for the personnel to be aware of various characteristics of the fluid or infusion apparatus to avoid serious injury to the patient. For example, personnel awareness of prior use of or injection into an IV bag may prevent infusion of contaminated fluid or fluid with improper medication for a patient. Since the self-sealing material shows virtually no indication of a puncture, the IV bag does not provide any notification to medical personnel (e.g. nurse, pharmacist, etc.) of a prior injection of medication or a potentially dangerous substance. This may lead to an inadvertent injection of an improper combination of medications into the IV bag and/or infusion of dangerous substances into a patient, thereby causing significant patient injury. 
   There is therefore a need to develop an indicator of prior use of a medical item capable of informing medical personnel of the possibility that a medication has been added to an IV bag. More specifically, there is a need to develop a system of visually alerting medical personnel of a prior use of an IV bag injection port. 
   SUMMARY OF THE INVENTION 
   Accordingly, the present invention monitors an IV bag injection port and informs the user of prior injections. The present invention employs an object and/or a sealed chamber within a transparent IV fluid bag injection port. In the case of the object, notification of prior use is achieved when the object&#39;s appearance within the injection port is altered. With respect to the sealed chamber, the chamber&#39;s seal is breached to allow fluid to pass between the chamber and the IV bag to change the appearance of the contents of the chamber. Because the injection port walls are at least partially transparent, medical personnel are able to observe the altered appearance of either the object or the sealed chamber within the injection port. 
   An embodiment of the present invention may include positioning an object within the injection passageway of an injection port. The proximal end of the port includes a penetrable, resealable membrane. Within the port, the object is sized and/or positioned so that the needle must pass through the membrane and the object in order to discharge syringe fluid into the IV bag. The needle contacts the object to alter the object&#39;s appearance. 
   Alternative embodiments may be implemented in various manners. For example, a sealed chamber may be defined between the membrane and a fluid barrier isolating the chamber from fluid in the IV bag. The sealed chamber itself or an object disposed therein changes appearance to indicate prior use. With this arrangement, in order to introduce syringe fluid into the IV bag, the needle must pass through the membrane and chamber before breaching the fluid barrier. The visual notification of prior use occurs within the sealed chamber when either the needle alters the object&#39;s appearance, the object contacts fluid flowing from the IV bag through the breached fluid barrier into the chamber thereby changing the object&#39;s appearance, or fluid from the IV bag is present within the chamber. 
   Any object that is susceptible to a change in appearance when contacted by a needle may be utilized. For example, the object can be a device that is inflated within the passage of the injection port such that a needle passing through the injection port must pass through the inflated object, thereby deflating the object. The deflated object has a significantly different appearance than the inflated object. In any case, the mode of altering the object&#39;s appearance need not be inflation/deflation. Any other mode may be employed that utilizes contact between the object and the needle as it passes through the injection port passageway. For example, the object&#39;s appearance may be altered by pivoting the object within the injection port, where the syringe needle could provide the pivot force to pivot the object. 
   Further, a reactive material may be placed in the sealed chamber. The reactive material reacts by changing appearance upon contacting IV fluid. When pierced, the fluid barrier allows IV bag fluid to flow into the previously sealed chamber to interact with the reactive material to alter the appearance of that material. For example, the reactive material may change color or shape, or may dissolve when placed in contact with IV fluid. The altered appearance of the reactive material in the chamber notifies a user of a prior injection. A reactive material may be chosen to react with a particular substance. In other words, the reactive material may be utilized to specifically verify the presence of a particular substance in the IV bag. 
   Moreover, the sealed chamber may include an alert fluid. The fluid barrier separates the sealed chamber from the fluid in the IV bag. In this case, the visual alert is provided when the needle pierces the fluid barrier to allow the alert fluid to flow from the sealed chamber into to the IV bag. The visual alert can be amplified by providing a colored alert fluid (different from the color of the IV fluid) in the sealed chamber. In other words, the presence of the alert or colored fluid within the IV bag notifies medical personnel that the IV bag has received a prior injection. 
   In addition, the sealed chamber may be employed without an object. In this case, the visual alert is provided by the needle piercing the fluid barrier to allow fluid to flow from the IV bag into the sealed chamber. The presence of fluid within the sealed chamber notifies medical personnel that the IV bag has received a prior injection. 
   The above and still further features and advantages of the present invention will become apparent upon consideration of the following detailed description of specific embodiments thereof, particularly when taken in conjunction with the accompanying drawings wherein like reference numerals in the various figures are utilized to designate like components. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  is a front view in elevation of an exemplary IV bag enclosed in a transparent packaging material and including an injection port that indicates a prior injection according to the present invention. 
       FIG. 2  is a perspective view of an injection port of the IV bag of  FIG. 1  including an inflatable balloon to indicate injection port usage according to the present invention. 
       FIG. 3  is a view in perspective and partial section of the seal element of the injection port of  FIG. 2 . 
       FIG. 4  is a perspective view of the section of the injection port of  FIG. 2  housing the inflatable balloon according to the present invention. 
       FIG. 5  is a perspective view of an alternative embodiment of an injection port including reactive paper or other material that changes color to indicate an injection according to the present invention. 
       FIG. 6  is a perspective view of yet another embodiment of an injection port including colored fluid to indicate an injection according to the present invention. 
       FIG. 7  is a perspective view of still another embodiment of an injection port including a sealed chamber to indicate an injection according to the present invention. 
   

   DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
   An exemplary IV bag including an injection port that indicates a prior injection according to the present invention is illustrated in  FIG. 1 . Specifically, IV bag  2  is enclosed in a transparent package covering  14 , preferably utilized during shipping to protect the bag. IV bag  2  includes a tab  4  at a bag upper end with an aperture  6  for hanging or suspending the bag from a structure (e.g., an IV pole, etc.). Bag  2  further includes a discharge port  15  and an injection port  100  each connected to a bottom bag area  7 . Discharge port  15  directs fluid from IV bag  2  to a patient, while injection port  100  enables injection of substances into IV bag  2  and notifies medical personnel of prior injections as described below. 
   Injection port  100  according to the present invention is illustrated in  FIG. 2 . Specifically, injection port  100  includes a seal element  200 , a needle port  300 , and a balloon  400 . Seal element  200  is disposed at an injection port proximal end and receives a syringe needle  350 . Needle port  300  is connected to the distal end of seal element  200  and extends for attachment to IV bag area  7 . Balloon  400  is disposed within an intermediate portion of needle port  300 , preferably in an inflated state, and is filled with the same or substantially similar IV fluid contained in the bag or other fluid harmless to the patient. When needle  350  is inserted into seal element  200 , the needle extends into and through needle port  300 , thereby puncturing balloon  400 . Balloon  400  is visible to medical personnel, where a deflated balloon status indicates a prior injection. 
   Referring to  FIG. 3 , seal element  200  includes a cap  220  and a projection  270 . Cap  220  is generally annular and includes a central opening or passage  230  defined therethrough. The opening includes transverse cross-sectional dimensions greater than those of a syringe or other needle  350  and less than those of needle port  300 . The proximal end of passage  230  is covered by a penetrable, resealable membrane  250 . The membrane is preferably constructed of a conventional self-sealing material to prevent leakage in response to withdrawal of needle  350  from injection port  100 . The material is typically of sufficient strength to withstand several injections without a leak. 
   Projection  270  is substantially cylindrical and extends from the distal end of passage  230 . The projection includes a channel  260  defined therethrough and transverse cross-sectional dimensions substantially similar to those of passage  230 . Needle port  300  is disposed over projection  270  and is attached to the distal end of cap  220 . The needle port may be attached to the projection outer surface and/or cap  220  via any conventional techniques (e.g., heat welding, heat sealing, adhesives, RF heating, etc.). The channel and cap passage enable syringe or other needle  350  to traverse seal element  200  for injection of medication into bag  2 . 
   Needle port  300  is illustrated in  FIG. 4 . Specifically, needle port  300  is preferably in the form of a generally cylindrical and transparent tubular member with a tube passage  315  defined therethrough. The transverse cross-sectional dimensions of tube passage  315  is slightly greater than those of projection  270  ( FIG. 3 ) to enable projection  270  to be received within a proximal portion of that passage as described above. The distal end of needle port  300  is attached to bag area  7  of IV bag  2 . Needle port tube passage  315  is in fluid communication with IV bag  2 , thereby enabling substances injected via the injection port to enter and mix with the IV fluid. 
   Since conventional injection ports merely include a self-sealing material, there is virtually no mechanism for recording the occurrence of a prior injection into an IV bag. Thus, medical personnel (e.g., a nurse, a pharmacist, etc.) may inadvertently provide IV bags with improper medication or other substances, or a contaminated IV bag may be inadvertently utilized, thereby risking injury to a patient as described above. The present invention employs an indicator within the injection port to indicate the occurrence of an injection to medical personnel. 
   In particular, needle port  300  includes a balloon  400  or other inflatable or enlarged object to indicate the occurrence of a prior injection. Balloon  400  is manufactured within needle port  300  and is preferably filled with air, substantially the same fluid within IV bag  2 , or another harmless substance. Balloon  400  is preferably disposed at the needle port proximal end to enable at least a minimal degree of insertion of needle  350  within the needle port to contact the balloon and indicate a prior injection. In other words, this enables the balloon to indicate prior full or partial insertions of syringe or other needles into the needle port. Partial (or full) needle insertions may occur due to tampering or inadvertent use by medical personnel. However, the balloon may be disposed at any suitable location within the needle port enabling or requiring contact with inserted needle  350  and visibility of the balloon to medical personnel. Balloon  400  is typically secured to the needle port interior surface via conventional techniques (e.g., heat welding, heat sealing, adhesives, RF heating, etc.) and may seal the fluid passageway against fluid flow. When a needle is inserted through membrane  250 , the needle enters needle port  300 . Since balloon  400  is disposed proximate cap  220 , the needle ruptures the balloon. The fluid contained by balloon  400  is released and the balloon enters a deflated state indicating the occurrence of the injection. Medical personnel view the deflated state of balloon  400  and are informed of a prior injection (e.g., or any tampering or inadvertent use due to a needle insertion). Thus, medical personnel (e.g., nurse, pharmacist, etc.) receiving an IV bag  2  according to the present invention may view the state of balloon  400  to determine the occurrence of prior injections or a compromised state of IV bag  2  prior to use. 
   Balloon  400  may be inflated and/or be secured to the needle port interior surfaces to form a seal and completely block fluid flow through needle port  300 . Since fluid cannot pass balloon  400 , fluid from needle  350  cannot enter the IV bag without the needle piercing balloon  400 . In other words, an inflated balloon  400  indicates that no syringe fluid has entered IV bag  2 . When a needle is inserted through membrane  250  and enters needle port  300 , the needle pierces balloon  400  and discharges syringe fluid into the IV bag fluid. 
   Different types of objects may be utilized in needle port  300  that alter appearance to indicate the occurrence of an injection. The objects may be ruptured, reoriented, deformed, change color, dissolve, swell or provide any other manner of visually alerting a user that an injection has occurred. The objects need only be arranged such that breach of the access to the IV bag fluid results in an altered appearance of the chosen object. 
   Referring to  FIG. 5 , a sealed chamber  460  may be defined within needle port  300  between cap  220  and a fluid barrier or membrane  450 . A needle  350  must pierce membrane  250  and penetrate fluid barrier  450  in order to introduce medication or other fluid into IV bag  2 . Fluid entering or leaving the breached chamber creates an informative difference in appearance. For example, a chemically sensitive paper or other substrate may be disposed within sealed chamber  460  in needle port  300  to indicate the occurrence of an injection. Initially, needle port  300  is substantially similar to the needle port described above and includes a chemically sensitive paper or other material  430  within sealed chamber  460 . Paper/material  430  is preferably dyed and reacts to fluid exposure by changing color. Basically, paper/material  430  measures alkalinity of the fluid, where paper/material  430  changes color in accordance with the alkalinity of the fluid contacting the paper. Paper/material  430  may be implemented by any conventional or other chemical sensing strips (e.g., pH paper, etc.) altering appearance to indicate results. Paper/material  430  is preferably secured toward an interior surface of tube passage  315  to avoid interfering with a needle  350  inserted into the injection port. 
   Fluid barrier  450  is disposed within tube passage  315  distally of paper  430  and includes dimensions sufficient to isolate paper  430  from fluid within IV bag  2 . Preferably, fluid barrier  450  is disposed toward the needle port proximal end as described above to be ruptured by needle  350  in response to at least a minimal degree of needle insertion within the needle port. Partial (or full) needle insertions may occur due to tampering or inadvertent use by medical personnel. However, fluid barrier  450  may be implemented by any suitable materials and may be disposed at any suitable location to isolate paper  430  and be contacted by an inserted needle  350 . When a needle is inserted through membrane  250  and enters needle port  300 , the needle pierces fluid barrier  450 , thereby causing fluid from IV bag  2  to flow into chamber  460  and contact paper/material  430 . Paper/material  430  changes color to indicate the occurrence of the injection (e.g., or any tampering or inadvertent use due to a needle insertion) and is visible through transparent needle port  300 . 
   In addition, a syringe needle may be partially inserted into sealed chamber  460  without piercing fluid barrier  450  to dispense fluid from the syringe. This may occur due to tampering or inadvertent use by medical personnel. In this case, the dispensed fluid contacts paper/material  430  that changes color to indicate the occurrence of the tampering or injection. 
   Further, a colored fluid may be utilized in sealed chamber  460  to indicate the occurrence of an injection as illustrated in  FIG. 6 . Initially, needle port  300  is substantially similar to the needle port described above and includes sealed chamber  460  with fluid barrier  450 . The sealed chamber further includes a sterile colored fluid  420  (e.g., fluid that will not cause injury to the patient). Fluid  420  is substantially similar to the fluid within IV bag  2  and may include any suitable additives to attain any desired color or other characteristic visually distinguishable from the fluid within IV bag  2 . Fluid barrier  450  is disposed in tube passage  315  of needle port  300  distally of fluid  420  and includes dimensions sufficient to isolate colored fluid  420  from the fluid within IV bag  2 . Preferably, fluid barrier  450  is disposed toward the needle port proximal end as described above to be ruptured by needle  350  in response to at least a minimal degree of needle insertion within the needle port. Partial (or full) needle insertions may occur due to tampering or inadvertent use by medical personnel. However, the fluid barrier may be disposed at any suitable location to enable or require contact by an inserted needle  350 . 
   When needle  350  is inserted through membrane  250  and enters needle port  300 , the needle pierces fluid barrier  450 , thereby causing colored fluid  420  to flow out of sealed chamber  460  and into IV bag  2 . The fluid in IV bag  2  changes color indicating the occurrence of the injection (e.g., or any tampering or inadvertent use due to a needle insertion). Alternatively, the colored fluid may be placed within a container, such as balloon  400 , that is disposed in needle port  300 . Preferably, the container is disposed at the needle port proximal end as described above to be ruptured by needle  350  in response to at least a minimal degree of needle insertion within the needle port. Partial (or full) needle insertions may occur due to tampering or inadvertent use by medical personnel. In this case, when the balloon is ruptured by the needle, the colored fluid is released and indicates occurrence of the injection (e.g., or any tampering or inadvertent use due to a needle insertion). 
   In addition, an empty sealed chamber  460  may be utilized to indicate the occurrence of an injection as illustrated in  FIG. 7 . Initially, needle port  300  is substantially similar to the needle port described above and includes sealed chamber  460  with fluid barrier  450 . When a needle  350  is inserted through membrane  250  and enters needle port  300 , the needle pierces fluid barrier  450 , thereby causing fluid from IV bag  2  to flow into chamber  460 . The presence of fluid in the chamber indicates the occurrence of the injection. 
   In addition, a syringe needle may be inserted into sealed chamber  460  without piercing fluid barrier  450  to dispense fluid from the syringe. This may occur due to tampering or inadvertent use of medical personnel. In this case, the presence of dispensed fluid in the chamber indicates the occurrence of the tampering or injection. 
   Operation of the present invention is described with reference to  FIGS. 1-7 . Initially, a patient is to be treated using IV bag  2  with an IV administration set. IV bag  2  includes injection port  100  for introducing medicine into the IV bag  2  via a syringe needle  350 , and discharge port  15  to enable fluid to flow to the patient. Medical personnel check object  400  or chamber  460  within needle port  300 , and/or the IV fluid for an indication of prior injections as described above. If an injection occurred, IV bag  2  is compromised and a new uncompromised IV bag  2  is selected for use. Once a satisfactory bag is selected, discharge port  15  is coupled to the administration set for infusion into the patient. Prior to or during infusion, medication may need to be introduced into the IV fluid. Accordingly, medical personnel insert a syringe or other needle  350  into injection port  100  via membrane  250 . The needle enters needle port  300  and pierces balloon  400  ( FIG. 1 ). The balloon subsequently deflates to indicate occurrence of the injection. Alternatively, injection port  100  may include a sealed chamber  460  ( FIGS. 5-7 ), where the chamber includes paper or other material  430  ( FIG. 5 ) or colored fluid  420  ( FIG. 6 ). In this case, the needle is inserted into needle port  300  and pierces fluid barrier  450  to expose the paper/material to fluid from IV bag  2  ( FIG. 5 ), to enable colored fluid  420  to enter the IV bag ( FIG. 6 ) or to enable fluid from the IV bag to enter the sealed chamber ( FIG. 7 ). The paper/material and IV fluid undergo a color change, whereas the sealed chamber receives fluid from IV bag  2 , to indicate the occurrence of the injection as described above. 
   It will be appreciated that the embodiments described above and illustrated in drawings represent only a few of the many ways of implementing a method and apparatus to indicate prior use of a medical item. 
   The IV bag may be of any shape or size, may be constructed of any suitable materials and may include any quantity of discharge, injection or other ports disposed at any suitable locations. The present invention may be utilized with any medical or other items (e.g., IV lines or connectors, solution containers, etc.) to indicate insertion of various fluids or substances. The injection port may be of any quantity, shape or size, may be constructed of any suitable materials (e.g., plastic, etc.) and may be disposed at any suitable locations. The injection port may be formed from a single piece, an integral unit or separate components (e.g., cap, needle port, etc.). The injection port may be attached to the IV bag via any conventional or other techniques (e.g., heat welding, heat sealing, screw thread, snap fit, RF heating, etc.). 
   The seal element may be of any quantity, shape or size and may be constructed of any suitable materials (e.g., plastic, etc.). The seal element may be formed from a single piece, an integral unit or separate components (e.g., cap, projection, etc.) and may be attached to the needle port via any conventional or other techniques (e.g., heat welding, heat sealing, RF heating, etc.). The membrane may be of any quantity, shape or size, may be disposed at any suitable locations and may be constructed of any suitable self-sealing or other materials preventing leaks. 
   The needle port may be of any quantity, shape or size and may be constructed of any suitable materials (e.g., materials for IV lines or tubes, plastic, etc.). The needle port may be transparent or translucent, or include sufficient transparent and/or translucent sections for visibility of the balloon, fluid or other object. The needle port may include any suitable object that alters appearance and/or position in response to contact with the fluid and/or needle (e.g., balloon, color changing material or fluid, deformable object, etc.). 
   The object may be of any quantity and disposed at any suitable location within the needle port. The colored fluid employed may be of any desired amount and may be of any suitable color distinguishable from the IV bag or application fluid. The reactive paper or material may be of any quantity, shape or size, and may be implemented by any material that may react or change characteristics (e.g., dissolve, change to any desired color or colors (e.g., preferably those that are easily visible or distinguishable from the needle port), change shape or size, etc.) in response to any suitable properties of the fluid (e.g., alkalinity, pH, temperature, etc.). The reactive paper may be configured to indicate the presence of any specific chemical, substance or type of fluid. 
   The sealed chamber may be of any quantity, shape or size, may be disposed at any suitable locations and may include any objects to indicate the occurrence of an injection, such as the objects described above. 
   The fluid barrier may be of any quantity, shape or size, may be disposed at any suitable locations isolating the object and/or chamber from the fluid and may be constructed of any suitable materials (e.g., plastic, etc.). The fluid barrier may alternatively be a rigid object that may be displaced or include displaceable sections in response to contact with the needle. 
   The injection port may be configured for use with any suitable instruments inserting medication or other substances or fluids into the IV bag. Further, the injection port may be utilized with any equipment utilizing injection ports or enabling introduction of medication or other substances or fluids (e.g., IV bags, IV administration sets, etc.). 
   The present invention may utilize plural indicators, where the alert mechanisms of present invention embodiments may be used individually or in any combination (e.g., a reactive material may be disposed within a sealed chamber with a deflatable object, colored fluid may be utilized in combination with the deflatable object, etc.). 
   The present invention is not limited to the applications described above, but may be utilized to notify a user of prior use or a compromised state of any medical or other item (e.g., IV line or connector, solution container, etc.). For example, the present invention may be utilized for any application where user notification is desired in response to an attempt to introduce a substance into an environment of concern. 
   From the foregoing description, it will be appreciated that the invention makes available a novel method and apparatus to indicate prior use of a medical item, wherein an object and/or a sealed chamber within an IV fluid bag injection port is employed to visually notify a user of prior use. 
   Having described preferred embodiments of a new and improved method and apparatus to indicate prior use of a medical item, it is believed that other modifications, variations and changes will be suggested to those skilled in the art in view of the teachings set forth herein. It is therefore to be understood that all such variations, modifications and changes are believed to fall within the scope of the present invention as defined by the appended claims.