Medical apparatus having elapsed time indicated and method of use

The time measuring and indication device is an invention that automatically measures and indicates elapsed time and is adapted to be connected to an IV or like medical apparatus. The device measures time by means of measuring the flow of a fluid having a known fluid flow rate. Prior to actuation, the device displays a first indicia such as the word “GOOD”, and after actuation and a predetermined lapse of time, the device displays a second indicia such as the word “EXPIRED”. The device further includes a means to halt or stop the time measuring function and to permanently display the elapsed period of time once the time measuring function is stopped. The time measuring and indication device further includes a means to prevent use of an apparatus such as an IV or like medical apparatus to which the device is attached, without activating the time measuring function of the device.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to devices used to measure and indicate the elapsed time of usage of a medical device and more especially to devices that prevent the usage of a medical device without the initiation of time measurement and to devices that record and indicate elapsed time at the completion of use of a medical device.

2. Description of the Related Art

Many products including common packaged food items and medical products have a finite shelf life defining a time period beyond which such products are rendered ineffective, and may even cause illness or injury. Thus, a need to track or measure the elapsed time from first use to expiration of such products has been identified. In response to such need, various elapsed time indication devices have been developed. An example of such time measuring and indication device is the device disclosed in published U.S. patent application 20040240324 by Ibitsky et al. Ibitsky teaches a device that measures time by means of measuring the migration of a fluid of a known viscosity from a first chamber to a second chamber. Upon the expiration of a predetermined time which is based of the rate of flow of the fluid, an indication such as an “expired” indication is displayed by the device. U.S. patent application 20040240324 is incorporated herein in its entirety by reference.

Further, in various industrial applications, human exposure to certain conditions such as a radioactive condition is know be tolerable or acceptable when less than a predetermined exposure and is know to be intolerable or unacceptable when greater than a predetermined exposure. Thus a need to track the duration and quantity of exposure has been identified. In response to such need, various exposure levels monitoring devices and various exposure elapsed time measuring and indication devices have been developed. Examples of such devices are disclosed in U.S. Pat. Nos. 4,903,254, 5,058,088, 5,364,132, 5,446,705, 5,602,804, 5,633,835, 5,699,326, 5,715,215, 5,719,828, 5,785,354, 5,822,280, 5,862,101, 5,873,606, 5,930,206, 5,947,369, 5,957,458, 6,295,252, 6,452,873, and 6,796,065. The listed patents are incorporated herein by reference.

In spite of the advances and advantages of the inventions described above, to the applicant's knowledge, no time indication device exists that is directly connected to routinely used medical devices such as an intravenously inserted tube and needle assembly (IV). It also noted that leaving an IV inserted into a patient beyond a predetermined generally accepted time period is believed to contribute to causing nosocomial infections or phlebitis in the patient. Further no such devices known to prevent use of a medical apparatus without the starting the timing of such timing device. Further, no such devices are known to record the point at which such devices are stopped in their time measuring function.

SUMMARY OF THE INVENTION

The present invention has been developed in response to the present state of the art, and in particular, in response to the medical applications that were described to be lacking in the art. Accordingly, the present invention is adapted to attach directly to an IV or like medical device, is adapted to prevent the use of such medical device without starting the timing function of the invention, and is adapted to stop the timing function and permanently record and display the elapsed usage time of the device for which time is tracked.

The invention comprises a time measuring and indication device that is adapted to be connected to an IV apparatus or like apparatus such as by the device being adhered to the IV or by the device being mechanically attached to the IV apparatus. The time measuring function of the device may be one of a variety of timing measuring functions such as a gas diffusion timing measuring function or an electronic timing measuring function. However, the time measuring function of the device is preferably substantially identically to the time measuring function of the timing device disclosed in U.S. patent application 20040240324. Thus the time measuring and indication device measures time by means of measuring the flow of a fluid having a known fluid flow rate. Before the time measuring and indication device is actuated, a first indicia such as the word “GOOD” is displayed by the device, and after a predetermined lapse of time, a second indicia such as the word “EXPIRED” is displayed by the device.

It is noted that the device may of course be attached to other items such as a substantially broad surface of a catheter or a portion of the device may be wrapped around a tube such as an IV tube. The device may even be attached directly to a patient. The time measuring and indication device further includes a means to halt or stop the time measuring function and to permanently display the elapsed period of time. Such time measurement stopping function is provided by causing a reacting fluid to be introduced to the flow fluid such that the flow of the flow fluid is stopped. The time measuring and indication device further includes a means to prevent use of an apparatus such as an IV apparatus or like medical apparatus to which the time measuring and indication device is attached, without first actuating the time measuring function of the time measuring and indication device. Such use prevention means is provided for instance by housing the time measuring and indication device within a housing assembly. The housing assembly defines a first housing member having a first eyelet and a second housing member having a second eyelet, the assembly of the two housing members defining a housing assembly having at least two eyelets in substantially close proximity to each other, and defining a housing assembly having an inner cavity in which the time measuring and indication device is positioned. A first IV end is retentatively positioned in the first eyelet and a second IV end is retentatively positioned in the second eyelet such that the IV may not be placed into use without separating the IV ends. The time measuring and indication device mounted within the housing assembly is adapted such that if the IV ends are separated, the first housing member slides away from the second housing member, causing a ramp formed in the first housing member to at least partially crush a bulbous activation button, thus causing the initiation of the time measuring function of the time measuring and indication device.

DETAILED DESCRIPTION OF THE INVENTION

The invention is an elapsed time indicating medical apparatus. The invention preferably includes means to assure timing device actuation if placing the medical apparatus in use and means to lock or “freeze” the elapsed time that is indicated at the completion of use of the apparatus. In order to facilitate the understanding of the present invention in reviewing the drawings accompanying the specification, a feature list is provided below. It is noted that like features are like numbered throughout all of the figures.

Referring now to the drawings and in particular toFIGS. 1 through 6, a first embodiment of the invention is a timing apparatus50for use in timing the duration of use of a medical device comprising a substantially flat, broad, and flexible substrate52, a layer of adhesive54, and an adhesive backing or protective cover56. Adhesive layer54is adhesively positioned between substrate52back surface and backing56. Timing apparatus50further includes a peel starter57located between a portion of adhesive layer54and a portion of an adhesive backing56and facilitates more ready removal of adhesive backing56from adhesive layer54. Timing apparatus50further defines a first portion60, a second portion80, and a flange74. First portion60is preferably frangibly connected to second portion80on a first end by means of a first portion to second portion perforated separation line89, and first portion60is preferably frangibly connected to flange74on a second end by means of a first portion to flange perforated separation line78.

First portion60further includes a timing fluid button62, a display window64, display window graduation marks66, a timing apparatus expiration indicia68, a timing apparatus maximum usage indicia70, and an identification indicia first instance72. Button62defines a compressible or crushable button containing display fluid90. Display window64defines a display fluid containable cavity, at least a portion of which is substantially transparent to reveal or display the contents of display window64. Button62is frangibly or rupturably connected to display window64by means of frangible wall63(not shown) such that compressing or crushing button62causes frangible wall63to break and display fluid90contained in button62to initiate flow into window64at a predetermined rate. Graduation marks66are positioned on window64such that the passage of time as measured from the initiation of flow of display fluid90is readily trackable or measurable by means of graduation marks66. It shall be noted however, that graduation marks66, while useful in assessing the passage of time, are nevertheless optional. Timing apparatus expiration indicia68is positioned near window64such that when display fluid90reaches expiration indicia68, maximum usage of apparatus50is indicated. Alternatively, expiration indicia68may be adapted such that expiration indicia68is only displayed upon expiration of apparatus50. Timing apparatus maximum usage indicia70is positioned on first portion60and indicates the maximum time for which the select apparatus50is usable. In the instance of apparatus50shown inFIG. 1, the 72 hour indicia is merely exemplary and may be more or less than 72 hours. Identification indicia first instance72is positioned on first portion60and defines an indicia unique to the instance of the apparatus50.

Second portion80further includes an identification indicia second instance82, a date indicia84, a time indicia86, and a patient name indication indicia88. Identification indicia second instance82, which is substantially identical to identification first instance72, is positioned on second portion80and may be used to associate first portion60with second portion80when first portion60is separated from second portion80. Date indicia84, time indicia86, and patient name indication indicia88are all positioned on second portion80and each provide an area that may be written upon so as to identify a date, time, and patient with which the use of apparatus50is associated. Additionally, other indicia preferably having a writable area associated with the other indicia may also be added to portion80.

Flange74further includes a flange hole76for use in attaching apparatus50to a medical device. Adhesive backing56further preferably includes a warning indicia92positioned on an external surface of backing56such that a user of apparatus50may readily be warned with a warning such as a warning regarding the capabilities and proper usage of apparatus50.

In practice, apparatus50is attached to an IV or like medical device by positioning a tube of an IV through flange hole76. Upon insertion of the IV into a patient, button62is compressed causing the initiation of flow of display fluid90from button62to window64. The user also writes or otherwise marks on portion80, the date and time of usage initiation of apparatus50and the name of the patient on whom apparatus50is used. Such marking will typically be performed after initiation of use of apparatus50but may alternatively be marked immediately prior to initiation of use of apparatus50. Usage of apparatus being thus initiated and markings being marked, apparatus50provides a sure means whereby the elapsed time of usage of apparatus50can be monitored and observed. With apparatus50thus monitoring elapsed time of usage corresponding to the duration of insertion of an IV or like medical device, excessive or undue prolonged insertion of an IV or like medical device is prevented. Upon completion of the time tracking function, apparatus50may be removed from an IV by tearing perforated separation line78. Adhesive backing56is then removed from adhesive layer54, and the remainder of apparatus50may be adhered to the paper medical record or like medical information tracking device corresponding to the patient on whom apparatus50was used. It is further noted that alternatively, only portion60or only portion80may be applied to the paper medical record or like medical information tracking device. Thus apparatus50further provides a permanent record of the duration of use of apparatus50and the corresponding medical device for which apparatus50tracked time usage.

Referring now to the drawings and in particular toFIGS. 7 and 8, a second embodiment of the invention is an elapsed time indicating medical apparatus100for use in timing the duration of use of medical apparatus100. Apparatus100comprises timing apparatus101and IV110. Apparatus101is substantially identical to and operates substantially identical to apparatus50except that in apparatus101flange74is replaced by connection bar102and third portion104, and perforated separation line78is replaced with perforated separation lines106. Third portion104defines a portion that is geometrically similar to first portion60and to second portion80. Connection bar102connects to second portion60on a first end and to third portion104on a second end. Rather than connecting timing apparatus101to IV110by a means of a flange as in apparatus50, timing apparatus101is adhered to IV110by wrapping connecting bar102around IV110, removing a portion of backing56from second portion60, adhering third portion104to second portion60. After the timing function of timing apparatus101is complete, timing apparatus101is removed from IV110by tearing perforated separation lines106. Adhesive backing56is then removed from the remainder of adhesive layer54, and the remainder of apparatus101may be adhered to the paper medical record or like medical information tracking device corresponding to the patient on whom apparatus100was used.

Referring now to the drawings and in particular toFIG. 9, a third embodiment of the invention is an elapsed time indicating medical apparatus120for use in timing the duration of use of medical apparatus120. In this embodiment, apparatus50preferably remains permanently adhered to IV110. It is noted however, that apparatus50alternatively forms a ring as shown inFIG. 9but apparatus50is not adhered to IV110but rather is mechanically retained to IV110such as by a groove in IV110or by an IV retaining flange or the like.

Referring now to the drawings and in particular toFIGS. 10 through 16, a fourth embodiment of the invention is a timing apparatus150for use in timing the duration of use of a medical device comprising a substantially flat, broad, and flexible substrate152, a layer of adhesive154(not shown), and an adhesive backing or protective cover156(not shown). Adhesive layer154is adhesively positioned between substrate152back surface and backing156. Timing apparatus150further includes a peel starter157(not shown) located between a portion of adhesive layer154and a portion of an adhesive backing156and facilitates more ready removal of adhesive backing156from adhesive layer154. Timing apparatus150further defines a first portion160, a second portion180, and a flange174. First portion160is preferably frangibly connected to second portion180on a first end by means of a first portion to second portion perforated separation line189, and first portion160is preferably frangibly connected to flange74on a second end by means of a first portion to flange perforated separation line78.

First portion160further includes a timing fluid button162, a display window164, display window graduation marks166, a timing apparatus expiration indicia168, a timing apparatus maximum usage indicia170, an identification indicia first instance172, a locking fluid button203, and a locking fluid frangible wall. Button162defines a compressible or crushable button containing display fluid190. Display window164defines a display fluid and a locking fluid containable cavity, at least a portion of which is substantially transparent to reveal or display the contents of display window164. Button203defines a compressible or crushable button containing locking fluid204. Button162is frangibly or rupturably connected to display window164by means of frangible wall163such that compressing or crushing button162causes frangible wall163to break and display fluid190contained in button162to initiate flow into window164at a predetermined rate. Further, button203is frangibly or rupturably connected to display window164by means of frangible wall206such that compressing or crushing button203causes frangible wall206to break and locking fluid204contained in button203to initiate flow into window164at a predetermined rate. Locking fluid204preferably flows at a much faster rate than display fluid190. When display fluid190comes into contact with locking fluid204, a solidification of at least a portion of the fluids occurs, solidified dam208is formed, and display fluid190is substantially stopped in its progress to substantially permanently record the fixed elapsed time. Solidified dam208may alternatively define a non-solidified dam such as a high viscosity gel dam so long as dam208functions to stop the migrations of display fluid190. Display fluid190and locking fluid204may be any of a broad number of reacting type fluids. For instance, display fluid190may be water when locking fluid204is cyanoacrylate (which cures upon contact with water). Alternatively display fluid190may be an adhesive in anaerobic environment (which cures upon contact with air) when locking fluid204is air. To better distinguish between display fluid190and locking fluid204, display fluid190may be of a different color than locking fluid204and the fluids may be of substantially contrasting colors. Graduation marks166are positioned on window164such that the passage of time as measured from the initiation of flow of display fluid190is readily trackable or measurable by means of graduation marks166. It shall be noted however, that graduation marks166, while useful in assessing the passage of time, are nevertheless optional. Timing apparatus expiration indicia168is positioned near window164such that when display fluid190reaches expiration indicia168, maximum usage of apparatus150is indicated. Alternatively, expiration indicia168may be adapted such that expiration indicia168is only displayed upon expiration of apparatus150. Timing apparatus maximum usage indicia170is positioned on first portion160and indicates the maximum time for which the select apparatus150is usable. In the instance of apparatus150shown inFIG. 10, the 72 hour indicia is merely exemplary and may be more or less than 72 hours. Identification indicia first instance172is positioned on first portion160and defines an indicia unique to the instance of the apparatus150.

Second portion180further includes an identification indicia second instance182, a date indicia184, a time indicia186, and a patient name indication indicia188. Identification indicia second instance182, which is substantially identical to identification first instance172, is positioned on second portion180and may be used to associate first portion160with second portion180when first portion160is separated from second portion180. Date indicia184, time indicia186, and patient name indication indicia188are all positioned on second portion180and each provide an area that may be written upon so as to identify a date, time, and patient with which the use of apparatus150is associated. Additionally, other indicia preferably having a writable area associated with the other indicia may also be added to portion80.

Flange174further includes a flange hole176for use in attaching apparatus150to a medical device. Adhesive backing156further preferably includes a warning indicia202(not shown) positioned on an external surface of backing156such that a user of apparatus150may readily be warned with a warning such as a warning regarding the capabilities and proper usage of apparatus150.

In practice, apparatus150is attached to an IV or like medical device by positioning a tube of an IV through flange hole176. Upon insertion of the IV into a patient, button162is compressed causing the initiation of flow of display fluid190from button162to window164. The user also writes or otherwise marks on portion180, the date and time of usage initiation of apparatus150and the name of the patient on whom apparatus150is used. Such marking will typically be performed after initiation of use of apparatus150but may alternatively be marked immediately prior to initiation of use of apparatus150. Usage of apparatus being thus initiated and markings being marked, apparatus150provides a sure means whereby the elapsed time of usage of apparatus150can be monitored and observed. With apparatus150thus monitoring elapsed time of usage corresponding to the duration of insertion of an IV or like medical device, excessive or undue prolonged insertion of an IV or like medical device is prevented. Upon completion of usage of the IV or like corresponding medical device, button203is compressed causing the initiation of flow of locking fluid204from button203to window164and further causes solidified dam208to form and substantially “locks” the elapsed time. After “locking” the elapsed time, apparatus150may be removed from an IV by tearing separation line178. Adhesive backing156is then removed from adhesive layer154, and the remainder of apparatus150may be adhered to the paper medical record or like medical information tracking device corresponding to the patient on whom apparatus150was used. It is further noted that alternatively, only portion160or only portion180may be applied to the paper medical record or like medical information tracking device. Thus apparatus150further provides a permanent record of the duration of use of apparatus150and the corresponding medical device for which apparatus150tracked time usage.

Referring now to the drawings and in particular toFIGS. 17 and 18, a fifth embodiment of the invention is an elapsed time indicating medical apparatus220for use in timing the duration of use of medical apparatus220. Apparatus220comprises timing apparatus50, IV assembly250, and actuator230. Actuator230comprises an elongated actuator body having an actuator chamber232, a first open slot234, a second open slot235, a ramp236, a bar240, a bar flange242, and a bar flange hole244. First open slot234is located on a first end of chamber232and second open slot235is located on a second end of chamber232. Ramp236is located within chamber232. A first end of bar240is connected to a second end of chamber232, and flange242is connected to a second end of bar240. Flange hole244is centrally located within flange242. IV assembly250includes an IV tube252and a plurality of IV tube retention flanges254. IV retention tube252defines an IV tube having a first end and a second end with each of tube252ends having a pair of IV retention flanges254retentatively connected to tube252. Each pair of retention flanges254forming a gap therebetween. Medical apparatus220is assembled such that button62of timing apparatus50is positioned within actuator chamber232in near proximity to ramp236and such that first portion60protrudes out of first open slot234and such that flange74protrudes out of second open slot235. Medical apparatus220is further assembled such that a first end of IV tube252passes through flange hole76, with flange74being retentatively positioned within a gap formed between two IV retention flanges254and such that a second end of IV tube252passes through actuator bar flange hole244, with flange242being retentatively positioned within a gap formed between two IV retention flanges254. It is noted that flange74and flange242may be alternatively secured to IV tube252such as by means of a compression fit between each of flanges74and242and IV252or by means of at least one retaining groove formed in IV252.

In practice, in order to initiate use of medical apparatus220, the ends of IV tube252must be separated. Separating the ends of IV tube252requires the application of two opposing forces applied in the direction of load direction indication arrows260. Such application of load in turn causes button62to be forced against and compressed by ramp236in actuator chamber232prior to timing apparatus50being withdrawn from actuator230. Thus by means of the described process, timing apparatus50of medical apparatus220is automatically initiated upon the separation of the end of IV tube252. Further, it is seen that without separating the ends of IV tube252and the resultant automatic initiation of timing device50, medical apparatus220is unable to be placed into use.

Referring now to the drawings and in particular toFIGS. 19 and 20, a sixth embodiment of the invention is an elapsed time indicating medical apparatus270for use in timing the duration of use of medical apparatus270. Apparatus270comprises timing apparatus50, IV assembly250, and actuator280. Actuator280comprises an elongated actuator body having an actuator chamber282, a first open slot284, a second open slot285, a ramp286, and an IV receptacle288. First open slot284is located on a first end of chamber282and second open slot285is located on a second end of chamber282. Ramp286is located within chamber282. IV receptacle288defines an additional cavity formed within actuator280. IV assembly250includes an IV tube252and at least one IV tube retention flange254. Medical apparatus270is assembled such that button62of timing apparatus50is positioned within actuator chamber282in near proximity to ramp286and such that first portion60protrudes out of first open slot284and such that flange74protrudes out of second open slot285. Medical apparatus270is further assembled such that a first end of IV tube252passes through flange hole76and such that IV tube252first end is housed within IV receptacle288. Flange74is further retentatively positioned adjacent at least one IV retention flange254such that IV tube252first end may not be removed from IV receptacle288but that a load is applied to flange74by at least one retention flange254.

In practice, in order to initiate use of medical apparatus270, the first end of IV tube252must be exposed by removing the first end of tube252from IV receptacle288. Such removal of tube252first end from receptacle288requires the application of two opposing forces applied in the direction of load direction indication arrows260. Such application of load in turn causes button62to be forced against and compressed by ramp286in actuator chamber282prior to timing apparatus50being withdrawn from actuator280. Thus by means of the described process, timing apparatus50of medical apparatus270is automatically initiated upon the removal of tube252first end from receptacle288. Further, it is seen that without removing tube252first end from receptacle288and the resultant automatic initiation of timing device50, medical apparatus270is unable to be placed into use.

Referring now to the drawings and in particular toFIGS. 21 and 22, a seventh embodiment of the invention is an elapsed time indicating medical apparatus300for use in timing the duration of use of medical apparatus300. Apparatus300comprises timing apparatus50, adhesive tape304, IV assembly310, and actuator320. Adhesive tape304defines a preferably disk shaped piece of adhesive tape but may alternatively be an adhesive tape form in a different shape. Adhesive tape304further includes a layer of adhesive305laminated between tape304and a tape backing306. Tape304also includes a tape peel starter307positioned between a portion of adhesive layer305and a portion of tape backing306such that where peel starter307lies between tape304and backing306, backing306is not adhered to tape304. Tape backing306defines substantially the same footprint of perimeter shape as tape304such that removal of tape backing306from tape304is substantially difficult without the use of tape peel starter307. IV assembly310includes an IV tube312connected to an IV needle314. IV needle314further defines a needle body316connected to a needle tip318. Actuator320comprises an elongated actuator body having an actuator chamber322, a first open slot324, a second open slot325, and a ramp326. First open slot324is located on a first end of chamber322and second open slot325is located on a second end of chamber322. Ramp326is located within chamber322. Medical apparatus270is assembled such that button62of timing apparatus50is positioned within actuator chamber282in near proximity to ramp286and such that first portion60protrudes out of first open slot284and such that flange74protrudes out of second open slot285. Medical apparatus300is further assembled such that timing apparatus50is adhered to tape304and such that timing apparatus50and tape304are positioned within actuator320.

In practice, IV needle tip318is inserted into a patient and tape304, with timing apparatus50adhered to tape304, has backing306removed from tape304and tape304is placed over at least a portion of IV assembly310and a portion of the patient's body in near proximity to the needle tip318insertion site, to help retain IV assembly310in a proper position. However, in order to remove tape backing306from tape304, actuator320must be removed from timing device50in order to expose tape peel starter307. Removal of actuator320requires the application of two opposing forces applied in the direction of load direction indication arrows260. Such application of load in turn causes button62to be forced against and compressed by ramp326in actuator chamber322prior to timing apparatus50being withdrawn from actuator320. Thus by means of the described process, timing apparatus50of medical apparatus300is automatically initiated upon the removal of actuator320from timing apparatus50and tape304. Further, it is seen that without removing timing apparatus50and tape304from actuator320, medical apparatus300is unable to be placed into use.