WO2012027342A1

WO2012027342A1 - Timing arrangement for medical devices

Info

Publication number: WO2012027342A1
Application number: PCT/US2011/048771
Authority: WO
Inventors: Rashmi Sharma; Sanjiv K. Sharma
Original assignee: Rashmi Sharma; Sharma Sanjiv K
Priority date: 2010-08-23
Filing date: 2011-08-23
Publication date: 2012-03-01

Abstract

A timing arrangement for at least one medical device, including a housing at least partially containing a timing mechanism configured to measure elapsed time from a set start point, wherein the housing is integral with or attached to the at least one medical device; and an indicator configured to at least visually indicate the time period that has passed since the set start point. A method for determining the amount of time at least one medical device has been used in connection with a patient is also disclosed.

Description

TIMING ARRANGEMENT FOR MEDICAL DEVICES

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority from United States Provisional Application No. 61/376,046, filed August 23, 2010, which is incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

Field of the Invention

[0002] The present invention relates generally to portable devices and arrangements for use in connection with medical devices, and in particular to a timing arrangement for use in connection with a medical device that is inserted into the human body, such as a central venous line, a dialysis catheter, an arterial line, a urinary catheter, an endotracheal tube, and the like.

Description of the Related Art

[0003] In many instances and cases involving medical procedures and processes, one or more medical devices must be inserted into the internal area of the human body. For example, such insertable medical devices and systems include, without limitation, a central venous line, a dialysis catheter, an arterial line, a urinary catheter, an endotracheal tube, and the like. However, it is important for the doctor to understand how long the medical device has been located in the patient or the time period since medical device expiration.

[0004] In one particular area of medicine, central venous lines and/or a dialysis catheter are utilized for management of seriously ill patients. These lines provide vital information about fluid status, and are also used for life-saving drug administration, feeding, and dialysis. However, such lines are potentially a source of infection, and therefore, must be reviewed on a daily basis. For example, catheters are removed if not required, or replaced with a new line, if it has been in situ for approximately 10 days (or the number of days set forth in the policy or guidelines of the hospital). Therefore, it is important to track the time that such lines or other medical devices have been located within or in connection with the patient.

[0005] In order to track the residence time of the line, and as is known, the elapsed time (normally in days) is manually recorded on a set schedule in a patient observation chart by a nurse or doctor. Further, this information can be manually recorded in the daily progress notes associated with the specific patient, and all of these documents are generally filed in the patient case notes/file. As would be expected, and based upon the reliance on the manual note-taking process, human error may lead to incorrect information, or in some cases, a total lack of any timing data. This leads to the existence of lines in a patient for a longer period than allowed or recommended. This further leads to the inconvenience and inefficiencies involved in a person having to piece together the information after-the-fact, or attempting to gather this infomiation from existing patient notes (again, which may be incorrect or missing).

[0006] This existing manual-review process may then lead to mismanagement of line (or other medical device) usage, which can potentially result in patient infection from the line. Such patient infection may lead to a requirement for antibiotics with associated risk of side effects and financial implications, avoidable increase in morbidity, and even mortality. Known timing arrangements and devices are shown and described in U.S. Patent Nos.: 6,781,923; 7,254,095; 7,388,814; 7,463,558; and 7,729,206. However, there remains a need in the art for a timing arrangement that can be used in connection with medical devices that are inserted in the patient and provides accurate infomiation regarding the residence time of such devices. SUMMARY OF THE INVENTION

[0007] Therefore, generally, the present invention provides is a timing arrangement for use in connection with a medical device that addresses some or all of the deficiencies and drawbacks described above. Preferably, the present invention provides a timing arrangement for use in connection with a medical device that is a single-use arrangement. Preferably, the present invention provides a timing arrangement for use in connection with a medical device that can be attached to the medical device and/or an area on or around the patient. Preferably, the present invention provides a timing arrangement for use in connection with a medical device that measures the time from insertion of the medical device in the patient. Preferably, the present invention provides a timing arrangement for use in connection with a medical device that can be used in connection with a variety of medical devices, such as a tube, a conduit, a central venous line, a dialysis catheter, an artificial line, a urinary catheter, an endotracheal tube, a chest drain line, a peritoneal drain line, a feeding tube, a gastrostomy tube, a surgical drain line, a nasogastric tube, a tube extending from a person into an outer environment, and the like.

[0008] Therefore, and in one preferred and non-limiting embodiment, provided is a timing arrangement for at least one medical device, including a housing at least partially containing a timing mechanism configured to measure elapsed time (e.g., in days) from a set start point, wherein the housing is integral with or attached to the at least one medical device; and an indicator configured to at least visually indicate the time period that has passed since the set start point.

[0009] In another preferred and non-limiting embodiment, provided is a method Re^¬ determining the amount of time at least one medical device has been used in connection with a patient. The method includes: associating a housing having a timing mechanism at least partially contained therein with the at least one medical device associated with the patient; measuring, by the timing mechanism, elapsed time from a set start point at which the medical device was associated with the patient; and visually indicating the time period that has passed since the set start point.

[0010] These and other features and characteristics of the present invention, as well as the methods of operation and functions of the related elements of structures and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention. As used in the specification and the claims, the singular form of "a", "an", and "the" include plural referents unless the context clearly dictates otherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Fig. 1 is a schematic view of one embodiment of a timing arrangement for a medical device according to the principles of the present invention;

[0012] Fig. 2 is a schematic view of another embodiment of a timing arrangement for a medical device according to the principles of the present invention;

[0013] Fig. 3 is a schematic view of a further embodiment of a timing arrangement for a medical device according to the principles of the present invention;

[0014] Fig. 4 is a schematic view of another embodiment of a timing arrangement for a medical device according to the principles of the present invention;

[0015] Fig. 5 is a schematic view of a further embodiment of a timing arrangement for a medical device according to the principles of the present invention; [0016] Fig. 6 is a schematic view of a still further embodiment of a timing arrangement for a medical device according to the principles of the present invention; and

[0017] Fig. 7 is a schematic view of another embodiment of a timing arrangement for a medical device according to the principles of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS)

[0018] For purposes of the description hereinafter, the terms "end", "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting. Further, it is to be understood that the invention may assume various alternative variations and step sequences, except where expressly specified to the contrary.

[0019] The present invention is directed to a timing arrangement 10 for use in a medical environment, such as a hospital, a doctor's office, a medical facility, or the like. Various preferred and non-limiting embodiments of this timing arrangement 10 are illustrated in Figs. 1-6. Further, the timing arrangement 10 is used in connection with at least one medical device M that is inserted into or otherwise invasively used in connection with a patient P. For example, this medical device M may be a tube T (e.g., a tube, a conduit, a central venous line, a dialysis catheter, an artificial line, a urinary catheter, an endotracheal tube, a chest drain line, a peritoneal drain line, a feeding tube, a gastrostomy tube, a surgical drain line, a nasogastric tube, or the like), which is inserted at least partially into the patient, thereby extending from the patient P into the outer environment. It is also envisioned that the timing arrangement 10 of the present invention can be used at home by, for example, patients that have a long-term central line for administration of chemotherapy for various cancers and /or a long-term line for intravenous nutrition.

[0020] In addition, such a tube T may be attached to a container that delivers or receives fluid material, such as blood, urine, medicine, nutrition, or the like, or represent a conduit for other medical devices, lines, and/or materials. Of course, the tube T may be detached with a free end extending from the patient P. Further, in many instances, the tube T is in communication, e.g., fluid communication, with an on-site medical interface I, such as a computing device or the like. Normally, a user U, such as a nurse or doctor, interacts with the interface I in order to monitor the patient P and the medical devices M used in comiection with the patient P. Accordingly, the interface I includes a display D that visually and/or audibly represents and presents this information and data to the user U.

[0021] As discussed above, there are issues that may arise when certain medical devices M and/or tubes T are left partially or fully inserted in a patient P for a greater than acceptable time, often measured in days after initial insertion. Of course, in comiection with the timing arrangement 10 of the present invention, this time increment may be in months, weeks, days, hours, minutes, seconds, or some other configurable increment. Regardless, the present invention provides a unique and efficient way to quickly determine how long the medical device M or tube T has been "in" the patient P (or from some other set point or event).

[0022] With reference to Fig. 1, one preferred and non-limiting embodiment of the present invention is illustrated. In particular, the patient P has a tube T inserted into his or her body, and this tube T is in fluid or electrical communication with the medical interface I having a display D. In this embodiment, the timing arrangement 10 includes a housing 12, which at least partially contains or houses a timing mechanism 14. The timing mechanism 14 is configured, programmed, or adapted to measure elapsed time from a set start point, and it is envisioned that any suitable timing mechanism or device can be used, hi particular, the timing mechanism 14 should include the necessary components and features to accurately measure elapsed time in specified and/or configurable increments.

[0023] In order to start the timing mechanism 14 (thus detennining elapsed time from the set start point), an actuator 16 is used. This actuator 16 may be a button or other interactive element that allows the user U to start the timing mechanism 14. However, it is also envisioned that the timing mechanism 14 can be initiated automatically upon contact or attachment to medical device M, or automatically or manually by the user U at the medical interface I. All such arrangements that can automatically or manually allow for the initiation of the timing mechanism 14 are considered to be within the scope and context of the present invention.

[0024] In order to operatively associate the timing mechanism 14 to the medical device M (or tube T), the housing 12 may be attached to or integrated with the medical device M. As shown in the embodiment of Fig. 1, the housing 12 is attached to the tube T via a connection arrangement 18, such as through the use of a clip, connector, elastic member, adhesive material, attachment arrangement, or the like. Of course, the medical device M or tube T may also have a portion or arrangement specifically configured or structured to interact with the connection arrangement 18 (or directly with the housing 12). Also, it is envisioned that the connection arrangement 18 can interact with the timing mechanism 14, such that the timing mechanism 14 is actuated when the act of connection occurs. In such an embodiment, a separate actuator 16 would not be required. While a removably-attachable connection arrangement 18 can be used, it is preferable (in certain instances and for safety and health reasons) to ensure that the housing 12 is discarded with the medical device M or tube. Therefore, in a preferred and non-limiting embodiment, the connection arrangement 18 provides for a permanent connection of the housing 12 to the medical device M or tube T. Still further, it is envisioned that the timing mechanism 14 is integrated as part of the medical device M at the time of manufacture.

With continued reference to Fig. 1, the timing mechanism 14 is in communication with the medical interface I, such that the timing data and information derived from the timing mechanism 14 is presented to the user U on an indicator 20, which, in this embodiment, is in the form of the display D of the medical interface I. Further, in this embodiment, the timing mechanism 14 (and/or the housing 12) is in hard- wired communication with the medical interface I. Accordingly, the user U is provided with the important elapsed time information and data for use in interacting with the patient P. A variety of information can be provided to the user U by the indicator 20 (or display), including, but not limited to: timing arrangement data (e.g., data and information regarding the timing arrangement 10, the timing mechanism 14, and/or any of the components thereof), time data (e.g., data and information related to the input or output of the timing mechanism 14 and/or the timing arrangement 10), elapsed time data, set start point data, medical device data (e.g., data and information regarding the medical device M or its components), medical interface data (e.g., data and information regarding the medical interface I or its components), alarm data (e.g., data and information relating to an alarm condition, an alarm status, and/or similar alarm-related data, whether generated by the timing arrangement 10 or the medical interface I), patient data (e.g., data and information relating to the patient P that is utilizing the medical device M), and/or user data (e.g., data and information relating to the user U, such as the doctor or nurse, and whom normally interact with the patient P and/or the medical interface I).

[0025] It is further envisioned that the medical interface I includes a computing device configured, programmed, or adapted to receive and process the incoming data from the timing mechanism 14 and generate information for display to the user U. In addition, the medical interface (or in other embodiments, the timing mechanism 14) is configured, programmed, or adapted to provide an aural, tactile, or visual alarm to the user U. For example, if the medical device M has been left in too long, or is quickly approaching the need for replacement, this information can be provided to the user U through such an alarm.

[0026] Another preferred and non-limiting embodiment of the present invention is shown in Fig. 2. In this embodiment, the housing 12 is integrated with and/or permanently attached to the medical device M or tube T, whether in the manufacturing process or thereafter. Therefore, a separate connection arrangement 18 is not required. Further, the timing mechanism 14 interacts directly with the medical interface I through a wireless communication path. This would avoid the need for another wire connecting the housing 12 and the medical interface I.

[0027] A further preferred and non-limiting embodiment of the timing arrangement 10 of the present invention is illustrated in Fig. 3. In this embodiment, timing mechanism 14 provides information and data to a locally-situated indicator 20, which may be in the form of a display and provides the timing data and information to the user U. This generated and/or display data and information may include any of the above-discussed data, including, but not limited to: timing arrangement data, time data, elapsed time data, set start point data, medical device data, medical interface data, alarm data, patient data, and/or user data.

[0028] This indicator 20 can take a variety of forms, as discussed hereinafter. For example, as illustrated in Fig. 3, the indicator 20 may be a display 22 that visually presents the information to the user U in the same or similar manner as discussed above in connection with the display D of the medical interface I. Accordingly, this display 22 can be supported or operable through a computer or processor, such as a local processor that also supports or acts as the timing mechanism 14. Additionally, this display can be used to generate aural, tactile, and/or visual alarms (as discussed above). The timing data and information can take a variety of forms, and may be presented in a variety of manners to the user U (whether on the indicator 20, the display 22, and/or the display D of the medical interface I). In particular, the indicator 20 can be configured to provide various visual representations of the time increments (and/or any of the time data). Accordingly, the visual representation may be in the form of: a row, a pie slice, a flashing element, a colored shape, and/or alphanumeric. For example, as seen in the preferred and non-limiting embodiment of Fig. 4, the display 22 shows a row 24 indicating how many days the medical device M or tube T has been resident in the patient P. Further, the display 22 also includes a row 26 that is a colored or shaded area that visually represents the number of days (or other configurable time increment) that has elapsed since insertion of the medical device M or tube T. In this embodiment, the row 26 includes green-colored bars 28 for days 1-6, orange-colored bars 30 for days 7 and 8, and a red colored bar 32 for day 9. Of course, any configuration, color variation, visual presentation, or the like can be used without departing from the spirit and scope of the present invention. For example, the orange-colored bars 20 may flash at a set rate, while the red-colored bar 32 may flash at a faster rate (or, in one embodiment, be accompanied by a visual or audible alarm). In addition, in the embodiment of Fig. 4, the housing 14 is attached to the tube T through the use of the above- discussed connection arrangement 18.

[0029] With reference to the preferred and non-limiting embodiment of Fig. 5, the display 22 shows a circular indication 34, with the days positioned on the outer perimeter. The circular indication 34 is divided into green-colored pie slices 36 for days 1-8, orange- colored pie slices 38 for days 9-11, and a red-colored pie slice 40 for day 12. Again, any similar visual arrangement could be used, and presented on the indicator 20, or the displays 22, D. In addition, in this embodiment, the housing 12 is integrated with the tube T, thus ensuring that the timing mechanism 14 cannot be accidentally or deliberately removed or disassociated from the medical device M or tube T.

[0030] In the preferred and non-limiting embodiment of Fig. 6, the indicator 20 is a digital display 42, which indicates the number of days the medical device M or tube T has been resident in the patient (i.e., the length of time from the initial start time or timing mechanism 14 actuation), as well as the number of days remaining until a change of the medical device M is required. Further, a light indicator 44 is provided and attached to or associated with the housing 12. This light indicator 44 may be supported or operable by a computer device or process, whether a processor that controls the timing mechanism 14 or some other local or remote processor. Additionally, this light indicator 44 may flash, project certain colors, project different patterns, or, if some audio device is included or associated therewith, provide an audible alarm. Also, in this embodiment, the housing 12 is integrated or permanently attached to the tube T.

[0031] In another preferred and non-limiting embodiment, and as illustrated in Fig. 7, the housing 12 may include multiple displays 22, such as both the above-discussed digital display 42, as well as a color-based display 46. The digital display 42 provides time data to the user U, such as the time increments (e.g., days) remaining for proper and/or allowable safe use of the medical device M, or count-up of the time increments that the medical device M has been used. The color-based display 46 includes bars 48, which successively illuminate or otherwise visually display a color (or pattern) to the user U. For example, in the embodiment of Fig. 7, three bars 48 are used and display green, yellow, and red. Accordingly, this embodiment uses the well-known "traffic light" coloring to indicate the time data, e.g., the status of the use of the medical device M, to the user U. Of coixrse, any type of coloring or visual indication can be used to visually convey this information. [0032] As discussed above, the timing arrangement 10 can take a variety of forms and functions without departing from the spirit and scope of the present invention. For example, the housing 12 may be square-shaped, circular, tubular, global, or any other shape. Further, the timing mechanism 14, the visual indicator 20, or any other component of the timing arrangement 10 may be battery-operated, solar-powered, hard-wired, and/or configured with some ability to accept or generate electrical power. Similarly, the indicator 20 can take a variety of forms for effectively and visually conveying the information and data to the user U. For example, it is envisioned that at least a portion of the indicator 20 or display 22 may be in the form of a biodegradable material that, over time, changes color or visual appearance, thus providing some positive visual indication to the user U.

[0033] While the timing arrangement 10 of the present invention has been described above in connection with days, any time increment (months, weeks, hours, minutes, seconds, etc.) can be used. Further, the timing mechanism can be configured, programmed, or adapted to implement any of the above functions, whether through a local processor or computer device (e.g., positioned within the housing 12) or some remote processor (e.g., the processor of the medical interface I or display D). In addition, the timing arrangement 10 of the present invention can be used in connection with any suitable medical device M, but is preferably used with medical device M that are inserted into or invasive with respect to the patient P.

[0034] In this manner, the present invention provides a timing arrangement 10 that is associated with a particular patent P and a specific medical device M, and which measures or senses the elapsed time since insertion or use of the medical device M. Further, the timing arrangement 10 of the present invention can be used in connection with a variety of different medical devices M, e.g., a central venous line, a dialysis catheter, an arterial line, a urinary catheter, an endotracheal tube, and the like. [0035] In addition, the timing arrangement 10 provides a fast and accurate means for the user U to check how long the medical device M has been used in connection with the patient P. This reduces the chance of human error, and represents a cost effective way to deliver better care to the patient P. Further, the present invention will reduce or eliminate the time presently required searching for the timing data and information in the patient notes, and will reduce or eliminate the possibility of legal ramifications associated with infection from such medical device M (e.g., a tube T left in the patient P for an excessive period of time, which may lead to infection).

[0036] Although the invention has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

THE INVENTION CLAIMED IS

1. A timing arrangement for at least one medical device, comprising:

a timing mechanism configured to measure elapsed time from a set start point;

a housing at least partially containing the timing mechanism therein, wherein the housing is integral with or attached to the at least one medical device; and

an indicator configured to at least visually indicate the time period that has passed since the set start point.

2. The timing arrangement of claim 1, wherein the at least one medical device at least partially comprises at least one of the following: a tube, a conduit, a central venous line, a dialysis catheter, an artificial line, a urinary catheter, an endotracheal tube, a chest drain line, a peritoneal drain line, a feeding tube, a gastrostomy tube, a surgical drain line, a nasogastric tube, a tube extending from a person into an outer environment, or any combination thereof.

3. The timing arrangement of claim 1, further comprising an on-site medical interface, wherein the at least one medical device is in fluid communication with the on-site medical interface.

4. The timing arrangement of claim 1, wherein the indicator is in the form of a display configured to display content to a user, the content comprising at least one of the following: timing arrangement data, time data, elapsed time data, set start point data, medical device data, medical interface data, alarm data, patient data, user data, or any combination thereof.

5. The timing arrangement of claim 4, wherein the content at least partially comprises at least one visual representation of at least one time increment.

6. The timing arrangement of claim 5, wherein the at least one visual representation comprises at least one of the following: a row, a pie slice, a flashing element, a colored shape, alphanumeric text, or any combination thereof.

7. The timing arrangement of claim 4, wherein the display is positioned on an on-site medical interface that is in fluid communication with the at least one medical device.

8. The timing arrangement of claim 4, wherein the display is at least partially positioned on the housing.

9. The timing arrangement of claim 1, wherein time period that has passed since the set start point is measured in time increments, the time increments comprise at least one of the following: months, weeks, days, hours, minutes, seconds, a configurable increment, or any combination thereof.

10. The timing arrangement of claim 1 , wherein the timing mechanism is activated by at least one of the following:

(a) an actuator that is operable by a user;

(b) a button;

(c) an interactive element;

(d) automatically; (e) automatically upon contact or attachment of the housing to the at least one medical device;

(f) manually by the user at an on-site medical interface;

(g) manually by the user on the housing;

or any combination thereof.

11. The timing arrangement of claim 1 , wherein the housing is attached to the at least one medical device by a connection arrangement, the connection arrangement comprising at least one of the following: a clip, a connector, an elastic member, an adhesive material, an attachment arrangement, or any combination thereof.

12. The timing arrangement of claim 1, wherein the housing is permanently attached to or integral with the at least one medical device.

13. The timing arrangement of claim 1, wherein the indicator is configured to provide at least one of the following: an aural alarm, a tactile alarm, a visual alarm, or any combination thereof.

14. The timing arrangement of claim 1, wherein the indicator is at least partially in the form a light indicator attached to or associated with the filing.

15. The timing arrangement of claim 14, wherein the light indicator is configured to at least one of the following: flash, project a color, project a pattern, or any combination thereof.

16. The timing arrangement of claim 1, wherein the indicator is at least partially in the form of an audio device configured to provide an audible alarm.

17. The timing arrangement of claim 1, further comprising at least one processor in the housing, the at least one processor configured to receive, process, and/or transmit at least one of the following: timing aiTangement data, time data, elapsed time data, set start point data, medical device data, medical interface data, alarm data, patient data, user data, or any combination thereof.

18. The timing aiTangement of claim 17, wherein the at least one processor is in wireless communication with at least one on-site medical interface.

19. A method for determining the amount of time at least one medical device has been used in connection with a patient, the method comprising:

associating a housing having a timing mechanism at least partially contained therein with the at least one medical device used in connection with the patient;

measuring, by the timing mechanism, elapsed time from a set start point at which the medical device is associated with the patient;

visually indicating the time period that has passed since the set start point.

20. The method of claim 19, wherein the at least one medical device at least partially comprises at least one of the following: a tube, a conduit, a central venous line, a dialysis catheter, an artificial line, a urinary catheter, an endotracheal tube, a chest drain line, a peritoneal drain line, a feeding tube, a gastrostomy tube, a surgical drain line, a nasogastric tube, a tube extending from a person into an outer environment, or any combination thereof.