Method and apparatus to indicate prior use of a medical item

• US 8,444,599 B2
• Filed: 05/10/2010
• Issued: 05/21/2013
• Est. Priority Date: 10/27/2005
• Status: Active Grant

• Current Assignee: Patented Medical Solutions, LLC
• Original Assignee: Patented Medical Solutions, LLC
• Inventors: Faries, Durward I. Jr., Heymann, Bruce R., Hendrix, David, Gordon, John
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US12/776,654
• Publication Number:
  US 20100222763A1
• Time in Patent Office: 1,107 Days
• Field of Search: 604/97.01, 604/100.01, 604/408, 604/111, 604/404
• US Class Current: 604/111
• CPC Class Codes: A61B 2090/0807 Indication means
• CPC Class Codes: A61B 2090/0814 Preventing re-use
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/1412 Containers with closing means, e.g. caps
• CPC Class Codes: A61J 1/1462 Containers with provisions for hanging, e.g. integral adaptations of the container accessories for hanging the container A61M5/1414
• CPC Class Codes: A61J 1/1468 Containers characterised by specific material properties
• CPC Class Codes: A61J 1/1487 with friction fit, e.g. connecting tubes directly to a protruding port
• CPC Class Codes: A61J 2205/20 Colour codes
• CPC Class Codes: A61M 2039/0205 for injecting media
• CPC Class Codes: A61M 2039/222 frangible within tubing or bags
• CPC Class Codes: A61M 2205/273 preventing reuse, e.g. of disposables
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14

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'"'"'s or IV fluid'"'"'s appearance is altered. With respect to the sealed chamber, the chamber'"'"'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.

Claims

1. A method of notifying a user of a prior injection within a medical item including a receptacle containing a medical fluid, wherein said medical item includes a port to receive an injection of a medical substance for said medical item, wherein said port includes a membrane penetrable by an instrument, a tubular member extending from said membrane with a passage defined therethrough for fluid communication with said receptacle and to receive said instrument within said passage for said injection, and an indicator disposed within said passage and triggered by direct contact with said instrument, said method comprising:

(a) determining occurrence of said instrument penetrating said membrane and traversing said passage for said injection of said substance into said medical item and altering an appearance of at least one of said indicator disposed within said passage and said medical fluid to indicate said occurrence of said injection in response to said instrument triggering said indicator by traversing said passage and directly contacting said indicator during said injection.

2. The method of claim 1, wherein said indicator includes an inflatable device, and step (a) further includes:

(a.1) transitioning said inflatable device between inflated and deflated states in response to said instrument traversing said passage to indicate said occurrence of said injection.

4. The method of claim 1, wherein said indicator includes a chamber defined within said passage by a fluid barrier that isolates said chamber from said medical fluid, and wherein said chamber includes an object and step (a) further includes:

(a.1) altering an appearance of at least one of said object and said medical fluid in response to said instrument traversing said passage to indicate said occurrence of said injection.

8. The method of claim 1, wherein said indicator includes a chamber defined within said passage by a fluid barrier that isolates said chamber from said medical fluid, and step (a) further includes:

(a.1) enabling said medical fluid to flow within said chamber to indicate said occurrence of said injection in response to said instrument piercing said fluid barrier during traversal of said passage.

9. The method of claim 1, wherein said medical item includes a medical solution container.

10. The method of claim 1, wherein said medical item includes an intravenous solution bag, said port includes an injection port and said instrument includes a needle.

3. A method of notifying a user of prior use of a medical item containing a medical fluid, wherein said medical item includes a port with a passage to enable insertion of a substance into said medical item via an instrument, said method comprising:

(a) determining use of said medical item and altering an appearance of at least one of an indicator disposed within said passage and said medical fluid in response to said insertion of said instrument within said passage, wherein said indicator includes an inflatable device that is filled with a colored fluid, and step (a) further includes;

(a.1) altering an appearance of said medical fluid via said colored fluid to indicate said medical item use in response to said instrument piercing said inflatable device during said insertion within said passage.

5. A method of notifying a user of prior use of a medical item containing a medical fluid, wherein said medical item includes a port with a passage to enable insertion of a substance into said medical item via an instrument, said method comprising:

(a) determining use of said medical item and altering an appearance of at least one of an indicator disposed within said passage and said medical fluid in response to said insertion of said instrument within said passage, wherein said indicator includes a chamber defined within said passage by a fluid barrier that isolates said chamber from said medical fluid, and wherein said chamber includes an object and step (a) further includes;

(a.1) altering an appearance of at least one of said object and said medical fluid in response to said insertion of said instrument within said passage to indicate said medical item use, wherein said object includes a reactive material that changes a material characteristic in response to contact with said medical fluid, and step (a.1) further includes;

(a.1.1) altering said material characteristic to indicate said medical item use by enabling said medical fluid to contact said reactive material in response to said instrument piercing said fluid barrier during said insertion within said passage.

6. The method of claim 5, wherein said reactive material changes color in response to contact with said medical fluid, and step (a.1.1) further includes:

(a.1.1.1) changing said reactive material color to indicate said medical item use by enabling said medical fluid to contact said reactive material.

7. A method of notifying a user of prior use of a medical item containing a medical fluid, wherein said medical item includes a port with a passage to enable insertion of a substance into said medical item via an instrument, said method comprising:

(a) determining use of said medical item and altering an appearance of at least one of an indicator disposed within said passage and said medical fluid in response to said insertion of said instrument within said passage, wherein said indicator includes a chamber defined within said passage by a fluid barrier that isolates said chamber from said medical fluid, and wherein said chamber includes an object and step (a) further includes;

(a.1) altering an appearance of at least one of said object and said medical fluid in response to said insertion of said instrument within said passage to indicate said medical item use, wherein said object includes a colored fluid, and step (a.1) includes;

(a.1.1) altering said appearance of said medical fluid by said colored fluid to indicate said medical item use in response to said instrument piercing said fluid barrier during said insertion within said passage.