# Patent

## Title
Indicia informative of characteristics of insertable medical devices

## Abstract

A system by which resource information relating to an insertable medical device, such as an intravascular catheter, can be identified by its source so as to be accessed by a practitioner, caregiver, or patient, is disclosed. In particular, a resource information key is included at a predetermined key location on or proximate to the medical device, wherein the key indicates the source of the resource information. In one example embodiment, therefore, an insertable medical device for establishing intravascular access to a patient, such as a peripherally inserted central catheter (“PICC”), is disclosed and comprises: an internal portion, and a portion external to the patient that includes a resource information key indicating a website where a user can acquire resource information relating to the medical device. In other embodiments indicia are provided as quick response (“QR”) codes, and as various markings to indicate compatibility of the medical device with ethanol.

## Background
CROSS-REFERENCE TO RELATED APPLICATION
This application is a continuation-in-part of U.S. patent application Ser. No. 11/937,302, filed Nov. 8, 2007, and titled “Resource Information Key for an Insertable Medical Device,” which claims the benefit of U.S. Provisional Patent Application No. 60/864,806, filed Nov. 8, 2006, and titled “Medical Device Uniform Resource Identifier.” This application also claims the benefit of U.S. Provisional Patent Application No. 61/614,939, filed Mar. 23, 2012, and titled “Indicia Informative of Ethanol Locking Capability in a Catheter.” Each of the aforementioned applications is incorporated herein by reference in its entirety.


BRIEF SUMMARY
Manufacturers of medical devices, including those configured for insertion into the body of a patient, generally make every effort to ensure that each device is accompanied by a comprehensive collection of printed and other material intended to ensure that the device is placed and used correctly. Examples of such devices include peripherally inserted central catheters (“PICCs”), dialysis catheters, peripheral catheters, central venous catheters (“CVCs”), access ports, and other devices designed to provide vascular access to the patient.
Despite the above-mentioned efforts, however, situations may arise where further information regarding a particular medical device is desired or needed in order for the device to be properly employed. For instance, the accompanying medical device documentation may be misplaced or lost, or further information may be released after the device was manufactured and distributed. Such information may be needed by the practitioner placing the medical device in the patient, or by the patient or caregiver after device insertion. In these or other cases, it may be difficult for the practitioner, patient, or caregiver to readily acquire needed information relating to the device.
In light of the above discussion, therefore, a need exists for a solution that overcomes the above-identified challenges relating to the availability of medical device information for insertable medical devices.
Embodiments of the present invention have been developed in response to the above and other needs in the art. Briefly summarized, these embodiments are directed to a system by which resource information relating to an insertable medical device, such as an intravascular catheter, can be identified by its source so as to be accessed by a practitioner, caregiver, or patient. In particular, a resource information key is included at a predetermined key location on or proximate to the medical device, wherein the key indicates the source of the resource information.
In one example embodiment, therefore, an insertable medical device for establishing intravascular access to a patient, such as a peripherally inserted central catheter (“PICC”), is disclosed and comprises: an internal portion configured for intravascular insertion into the patient, and a portion external to the patient. The exterior portion of the PICC includes a resource information key that is positioned at a predetermined key location. The resource information key indicates a website where a user can acquire the resource information relating to the medical device.
In other embodiments, an insertable medical device includes a two-dimensional code, such as a quick response (“QR”) code that is electronically readable so as to provide information regarding a characteristic or other aspect of the medical device to a user or other person. In yet other embodiments, various indicia are disclosed for indicating to a user a particular characteristic of the medical device, such as its compatibility with respect to ethanol and other alcohol-based fluids.
These and other features of embodiments of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter.



BRIEF DESCRIPTION OF THE DRAWINGS
To further clarify the above and other advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
FIG. 1 is a top view of a peripherally inserted central catheter (“PICC”) partially inserted in the arm of a patient, thereby depicting one example of an insertable medical device that benefits from the present invention according to one embodiment thereof;
FIG. 2 is a perspective view of the PICC of FIG. 1 before insertion into a patient, including a resource information key according to one embodiment;
FIG. 3 is a close-up top view of a portion of the PICC of FIG. 2, showing further details of the resource information key;
FIG. 4 is a top view of a connector portion of the PICC of FIG. 2, showing a resource information key location according to one embodiment;
FIG. 5 is a top view of a clamp portion of the PICC of FIG. 2, showing a resource information key location according to one embodiment;
FIG. 6 is a top view of a bifurcation hub portion of the PICC of FIG. 2, showing a resource information key location according to one embodiment;
FIG. 7 is a top view of a catheter portion of the PICC of FIG. 2, showing a resource information key location according to one embodiment;
FIG. 8 is a top view of a portion of the PICC of FIG. 2, including a hang tag having a resource information key location according to one embodiment;
FIG. 9 is a perspective view of a PICC coupled with a stabilization device having a plurality of resource information key locations according to one embodiment;
FIG. 10 is a top view of a PICC and stabilization device together with a dressing having a plurality of resource information key locations according to one embodiment of the present invention;
FIG. 11 is a perspective view of a dual septum implantable access port, depicting an example of an implantable medical device that benefits from the present invention according to one embodiment thereof;
FIG. 12 is a bottom view of the dual septum implantable access port of FIG. 11, including a reversed radiopaque resource information key according to one embodiment of the present invention;
FIG. 13A is a perspective view of a catheter assembly including a coded indicium according to one embodiment;
FIG. 13B shows a sample QR code as a coded indicium according to one embodiment;
FIG. 14 is a top view of the bifurcation of the catheter assembly of FIG. 13A, showing the coded indicium;
FIG. 15 is a perspective view of an access port including a coded indicium according to one embodiment;
FIG. 16 is a top view of an access port including a coded indicium included on a septum thereof according to one embodiment;
FIG. 17 is a perspective view of a portion of a catheter assembly including certain indicia according to one embodiment;
FIG. 18 is a perspective view of a portion of a catheter assembly including certain indicia according to one embodiment;
FIG. 19 is a perspective view of a portion of a catheter assembly including certain indicia according to one embodiment;
FIG. 20 is a perspective view of a portion of a catheter assembly including certain indicia according to one embodiment;
FIG. 21 is a perspective view of a portion of a catheter assembly including certain indicia according to one embodiment;
FIG. 22 is a perspective view of a portion of a catheter assembly including certain indicia according to one embodiment;
FIG. 23 is a perspective view of a portion of a catheter assembly including certain indicia according to one embodiment;
FIG. 24 is a perspective view of a portion of a catheter assembly including certain indicia according to one embodiment;
FIG. 25 is a perspective view of a portion of a catheter assembly including certain indicia according to one embodiment;
FIG. 26 is a perspective view of a portion of a catheter assembly including certain indicia according to one embodiment;
FIG. 27 shows various symbols that may serve as indicia according to one embodiment; and
FIG. 28 is a bottom view of a radiopaque insert for use with an implantable port and including certain indicia according to one embodiment.



DETAILED DESCRIPTION OF SELECTED EMBODIMENTS
Reference will now be made to figures wherein like structures will be provided with like reference designations. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the invention, and are not limiting of the present invention nor are they necessarily drawn to scale.
I. Resource Information Key
FIGS. 1-10 depict various features of embodiments of the present invention, which is generally directed to a system by which resource information relating to an insertable medical device, such as an intravascular catheter device, can be identified so as to be accessed by a practitioner, caregiver, or patient.
Reference is first made to FIG. 1, which depicts a medical device, generally designated at 10, that is configured for insertion into a body 12 of a patient. In particular, the medical device 10 depicted in FIG. 1 is a dual lumen peripherally inserted central catheter (“PICC”), and is shown inserted in the arm of the patient body 12. Also shown in FIG. 1 is a resource information key location, to be described more fully below, generally indicated at 50.
It should be noted that, though the accompanying drawings depict a PICC device, other medical devices that are at least partially inserted into the patient can also benefit from the principles of the present invention to be described herein. Examples of such devices include dialysis catheters, peripheral catheters, cannulas, infusion sets, and other devices designed to enable intravascular access to the patient. In yet other embodiments, completely implantable devices, such as subcutaneous access ports, can also employ embodiments of the present invention. As such, the breadth of the present invention should not be construed as being limited to the medical devices explicitly depicted and described herein.
Reference is now made to FIG. 2, depicting in further detail the PICC shown in FIG. 1 before placement in a patient, here shown at 20. Comparison of FIG. 2 with FIG. 1 will reveal that the PICC 20 includes an internal portion 20A for insertion into the vasculature of a patient and an external portion 20B that remains outside of the body of the patient during PICC use. As embodiments of the present invention can be applied to other insertable medical devices, the internal and external portions of other devices would be varied according to the particular design of the insertable medical device. As shown, the PICC 20 generally includes a catheter 22, an extension leg assembly 24, and a bifurcation hub 26 that operably interconnects the catheter to the extension leg assembly.
In further detail, the extension leg assembly 24 is configured to enable the infusion or aspiration of fluids to or from the patient vasculature via the catheter 22 and bifurcation hub 26. The extension leg assembly 24 includes a first connector 30 and second connector 32 that are connected to a first extension tube 40 and a second extension tube 42, respectively. A first clamp 44 is included on the first extension tube 40, and a second clamp 46 is included on the second extension tube 42. Note that more or fewer extension tubes could be included with the PICC 20.
In accordance with one embodiment, a key is provided with the PICC 20 to enable further information relating to the PICC to be accessed by a patient, practitioner, caregiver, etc. Specifically, a resource information key location (“RIKL”), generally indicated at 50, is provided on the PICC 20. The RIKL 50 defines an area of the PICC 20 where a resource information key 52 is located. As will be described, the resource information key 52 provides data to one as to a source where further information regarding the PICC 20 can be accessed. Not providing the information itself, it instead acts as a “key,” enabling further PICC-related information to be located.
The contents of the resource information key 52 can be any alpha-numeric, typographical, graphical content or other visual indicia that can visually convey to the user the source where further information regarding the medical device can be found. As such, letters, numbers, graphical or other symbols, etc. may be used alone or in combination to form the resource information key 52. In yet another embodiment, the key could be identified not visually, but rather by palpation.
For example, and as shown in greater detail in FIG. 3, the resource information key 52 in one embodiment is implemented as a website uniform resource locator (“URL”), www.powerpicc.com, where a user can access via the Internet various web pages giving further information regarding the structure, use, precautions, or other aspects relating to the PICC 20. Such information may be beneficial to the user, or may be critical in order to ensure patient safety, especially in instances where printed material that originally accompanied the PICC 20 has been misplaced or lost, or when new information has become available regarding the PICC.
In light of the above discussion, it is appreciated that in accordance with embodiments of the present invention the resource information key 52 can take one of several forms, especially with regard to pointing the user to an Internet-based resource. As such, examples of a resource information key include a web address, URL, URI, IP address, etc., which in turn direct the user to a location on the Internet where the further information may be found. Of course, the content of the resource information key 52 can be varied according to the device on which it is found.
As shown in FIGS. 2 and 3, the resource information key 52 is included in the RIKL 50, which in turn is disposed on a portion of the second extension tube 42. Generally, the RIKL 50 is chosen so as to be easily viewable by the user. The RIKL 50 should also be sized large enough for the resource information key 52 to be read without undue effort. Generally, locations proximally disposed on the external portion of the medical device are advantageous so as to enable the key to be readily viewed. However, as will be seen in the additional example embodiments to be discussed below, the key may be located at a variety of locations on the medical device. The resource information key 52 can be defined on the RIKL 50 in a variety of ways, including etching, embossing, labeling, ink or other printing, etc.
As mentioned, though it is located on the second extension tube 42 in the embodiments shown in FIGS. 1-3, the resource location key in other embodiments can be positioned at other resource information key locations on the PICC or other insertable medical device. FIGS. 4-8 give various examples of such alternative placement locations for the resource information key. In FIG. 4, for example, the RIKL 50 is disposed on the first connector 30 of the extension leg assembly 24, while FIG. 5 shows the RIKL disposed on a cap 56 affixed to the first clamp 44.
In FIG. 6, the RIKL 50 is disposed on an axial portion of the bifurcation hub 26. Alternatively, the RIKL can be disposed on one or both of two suture wings 60 extending from the body of the bifurcation hub 26. In FIG. 7, the RIKL 50 is disposed on a proximal portion 22A of the catheter 22 that is not inserted into the patient. In FIG. 8, a hang tag 80 or other attachable component can be added to the PICC 20 to include the RIKL 50 thereon.
The embodiments shown in FIGS. 1-8 depict the RIKL 50 disposed on a portion of the PICC 20 itself. However, the RIKL may also be positioned on a component that is not part of, but typically used in conjunction with, the PICC 20 or other insertable medical device. In FIG. 9, for example, a catheter stabilization device sold under the trademark STATLOCK® is shown at 90 and is commonly used to assist in securing the PICC 20 in place after insertion into the patient vasculature. The stabilization device 90 includes a base 92 and a retention assembly 94 for retaining the bifurcation hub 26 of the PICC 20. The retention assembly 94 includes selectively closeable lids 96. FIG. 9 further shows two possible areas for the RIKL 50: on a portion of the device base 92, and on one or both of the lids 96. Other areas could, of course, be employed on the stabilization device 90 for positioning the RIKL 50.
FIG. 10 shows an adhesive dressing 100 that is commonly used to cover a portion of the PICC 20 and stabilization device 90 for increased hygiene. The dressing 100 here includes two RIKLs 50 as yet another example of possible locations for placement of the resource information key. It is appreciated that, in addition to the examples discussed above, many other key locations could be devised on a variety of insertable medical devices, including devices that are fully implanted in the patient body, such as access ports, if desired. The present invention should not therefore be limited to only what is explicitly shown and described herein.
FIGS. 11 and 12 depict the present invention as employed in yet another example embodiment. In particular, FIGS. 11 and 12 depict a dual-septum access port 110 configured for subcutaneous implantation into the body of a patient. The access port 110 includes a first septum 112 covering a first reservoir, and a second septum 114 covering a second reservoir. The reservoirs are defined by a body 116. The resource information key 52 is disposed at a predetermined resource information key location 50 on a bottom surface 118 of the access port body 116.
The key 52 in FIG. 12, “www.bardpp.com,” is positioned on the bottom surface 118 in an inverse, or mirror-image, configuration. Further, the material used to define the key 52 includes a radiopaque material such that the key 52 is visible when a radiographic, or x-ray, image is taken of the implanted access port 110. The inverse key 52 in this case will appear non-inverse when the x-ray image is viewed, allowing the orientation of the implanted access port to be readily ascertained. Of course, the key may be positioned in any one of a variety of configurations, inverse or not, and locations on the access port.
The content of the key 52 can also serve to identify the access port 110 in terms of type, size, manufacturer, etc., if desired. In addition, the key 52 provides a source to which an observer can go to access further information regarding the access port 110, as in previous embodiments. Note that, while shown here in connection with a dual-septum access port, single-septum or otherwise configured access ports, as well as other types of implantable medical devices, can also benefit from the principles described herein with regard to the present embodiment.
II. Coded and Ethanol-Related Indicia
Reference is now made to FIGS. 13A-14 in describing details of identifying indicia for a medical device according to one embodiment. As shown, FIG. 13A depicts a medical device, namely a catheter 120, generally including a distal portion 120A and a proximal portion 120B. In detail, the catheter 120 includes a catheter tube 222 defining one or more lumens. The catheter tube 222 defines two lumens, though the number of lumens can vary. Each of two extension legs 224 of the catheter 120 is in fluid communication with a respective one of the lumens of the catheter tube 222. A bifurcation 226 fluidly connects the lumens of the catheter tube 222 with the extension legs 224. Luer connectors 228 are disposed on proximal ends of the extension legs 224. Also, clamps 230 are disposed on the extension legs 224 to enable selective occlusion thereof.
In accordance with the present embodiment, a coded indicium 240 is included with the medical device shown here, i.e., the catheter 120. The coded indicium 240 is configured to provide information relating to a characteristic, property, and/or quality of the catheter 120 or other medical device with which it is associated. For instance, the coded indicium 240 can be utilized to access an Internet webpage or online resource, with a suitable Internet or web browser such as those found on smart phones, laptop computers, Internet-connected devices, etc., so as to enable a user to acquire further information regarding the catheter 120.
Examples of resources to which the coded indicium 240 can direct a user include: an Internet webpage giving further details and/or instructions regarding the medical device; visual and/or multimedia information, including videos that described and or demonstrate use of the medical device; instructional websites that direct a user how to insert, remove, and/or use the medical device; identification information regarding the medical device including type, size, manufacturer, etc.; warnings or official information promulgated by the manufacturer or an official or regulatory body; recently released or published information regarding the medical device, etc. These and other resources and information can be the targets to which a user is directed by the coded indicium 240.
In the present embodiment, the coded indicium 240 is implemented as a two-dimensional coded symbol, such as a quick response (“QR”) code 242. Specifically, and as shown in FIGS. 13A and 14, the QR code 242 is a two-dimensional matrix barcode and is included on a top portion of the bifurcation 226, a part of the proximal portion 120B of the catheter 120. A relatively larger view of the QR code 242 is shown in FIG. 13B. Note that the QR code 242 can be included at a suitable location on the catheter 120 in addition to what is shown in FIG. 13A, including placement of any of the components shown in FIG. 13A. The QR code 242 can be added to the catheter 120 using any acceptable process, including printing, adhesive sticker, etching or engraving, insert molding, etc. In addition, the QR code 242 can be included on suitable medical devices so as to be radioopaque, enabling identification of the medical device via x-ray imaging technology. Also, other two-dimensional coded symbols in addition to QR codes can be included on the medical device to serve as a coded indicium, as appreciated by one skilled in the art. Similarly, the size and particular configuration of the QR code can vary from what is shown here.
The QR code 242 is encoded so as to be electronically scannable—also referred to herein as machine readable or optically scannable—such that a device configured to scan and interpret QR codes can visually read the QR code and access the resource or information associated therewith for presentation to the user. One example of such a device is a smartphone with a camera that can take a picture of or otherwise electronically scan (such as via an optical scan) the QR code 242, then access the Internet or other portal so as to retrieve the resource or information with which the QR code is associated before presenting the resource or information to a user, such as on a display of the smartphone. Smartphones and other electronic devices commonly include, or can be modified to include, suitable software or applications that enable QR codes and other scannable codes to be imaged and interpreted. In another embodiment, a portable computer or special-purpose computing device can be used to scan, interpret, and access the resource or information associated with the QR code.
As an example of the above, the catheter 120 including the coded indicium 240 as seen in FIG. 13A can be inserted into a patient in order to establish vascular access. Before or after insertion of the catheter 120, a user can electronically scan the QR code 242 with a smartphone or other suitable scanning device including the appropriate software or application. Once the QR code 242 has been scanned, the software/application can convert the code to a uniform resource locator (“URL”) and direct a web browser on the smartphone to access a website or other Internet location and retrieve the resource and/or information associated with the QR code. The resource/information can include instructions for flushing the catheter 120, for instance. The resource and/or information will be displayed on the smartphone display, enabling the user to read and use information.
As mentioned, various other types of devices can be employed to scan, interpret, and present the QR code-associated information to the user. Also, in addition to remotely accessing information via the Internet or other source, other avenues for acquiring the information associated with the QR code can be employed, including accessing the information locally located on the smartphone or other scanning device itself.
FIGS. 15 and 16 show placement of the QR code 242 in accordance with other embodiments. In FIG. 15, an access port 260 is shown, including a body 262 and attached septum 264. A stem 266 extends from the port body 262. The QR code 242 is shown in this embodiment located on a lateral side of the port body 262, where it may be scanned prior to placement of the access port 260 into the body of a patient to access the corresponding information. In FIG. 16, the QR code 242 is positioned on the septum 264. In one embodiment, the QR code 242 of FIG. 16 can be configured to be radiopaque so as to enable identification of the access port 260 via the QR code 242 after the port has been subcutaneously implanted within the body of a patient. Thus, it is appreciated that use of the QR code to facilitate the acquisition of further resources/information regarding one of a variety of medical devices is contemplated.
Reference is now made to FIG. 17 in describing a medical device according to another embodiment. In particular, FIG. 17 shows a catheter 320 including an elongate catheter tube 322 defining two lumens, though other lumen configurations are also possible. A proximal end of the catheter tube 322 is operably attached to a bifurcation 326. A proximal end of the bifurcation 326 is operably attached to two extension legs 324, each defining a lumen such that a fluid path is defined between each extension leg and a corresponding lumen of the catheter tube 322. More or fewer extension legs can be included according to catheter design. Each extension leg 324 includes a corresponding luer connector 328. A clamp 330 is also optionally included on each extension leg 324.
In accordance with the present embodiment, various indicia are included with the catheter assembly or other medical device to an observer a predetermined characteristic, quality, property, or other aspect of the catheter assembly. In the embodiments described hereinbelow, the predetermined characteristic includes compatibility of the catheter with alcohol-based solutions such as ethanol, e.g., the ability of ethanol to be disposed within the catheter or extension leg lumens for a period of time so as to “lock” (also referred to herein as “ethanol lock”) the catheter and prevent clotting, sheath formation, and/or occlusion in or near the tip of the catheter. The use of ethanol to lock the lumen(s) of a catheter lumen is also useful for catheter infection prevention and treatment. “Ethanol compatibility” and “ethanol locking” are both used herein to indicate the ability of the catheter or other medical device to withstand the effects of such contact with ethanol (or other alcohol-based fluids, in one embodiment) without unacceptably degrading the catheter/device. In addition to indicating ethanol compatibility, the indicia to be described hereinbelow can indicate other characteristics, qualities, or properties of the catheter or medical device. Thus, the discussion to follow should not be considered limiting in any way.
In light of the above, FIG. 17 shows an ethanol lock indicium (“indicium” or “indicia”) 340, according to one embodiment, for indicating ethanol compatibility of the catheter 10, including the ability of the catheter to be locked with a solution containing liquid ethanol. As shown, the indicium 340 in the present embodiment is implemented as an indicator color 342A applied to the bifurcation 326 of the catheter 320 in combination with an alphanumeric marking 342B included on the clamps 330 of the extension leg 324,
In greater detail, the indicator color 342A of the bifurcation indicates to an observer in the present embodiment that the catheter assembly can be locked with ethanol. Such indication is important, as not all catheter assemblies are suitable for or can suitably withstand the presence of ethanol. In the present embodiment, the indicator color 342A disposed on the bifurcation 326 is yellow, though other colors may also be used to indicate this or another catheter/medical device characteristic, quality, or property. In addition, in the present embodiment the clamps 330 are also colored yellow to further indicate ethanol compatibility. More, fewer, or other components of the catheter or suitable medical device may be colored with a predetermined color to indicate the characteristic, quality, or property of the device.
The alphanumeric marking 342B mentioned above serves in the present embodiment as an additional component of the indicium 340, in combination with the bifurcation indicator color 342A. As shown in FIG. 17, the alphanumeric marking 342B is disposed on each of the clamps 330 and includes an alphanumeric message, namely, “EtOH,” a shorthand designation for ethanol. This indicates to an observer the compatibility of the catheter 320 with ethanol.
In one embodiment, one or more of the catheter tube 322, bifurcation 326, and extension legs 324 include an ethanol-resistant material, such as an aromatic polycarbonate polyurethane that is also rated to withstand typical power injection pressures of about 190 psi. Other suitable plastics can also be employed, including aromatic polyether, aliphatic polycarbonate, and aliphatic polyether polyurethanes. In one embodiment, an ethanol solution of about 70% concentration is employed in locking the catheter 320, though other concentrations and formulations can be employed and indicated by the indicium.
It is appreciated that the indicator color and alphanumeric marking that are included in the ethanol lock indicium of the present embodiment may be used together or separately, placed on differing parts or components of the catheter or medical device, and may be configured differently, as discussed further below. Also as mentioned, the indicium may be used to indicate other characteristics, qualities, and/or properties of the catheter or medical device. In the case of catheters, though the present figures show a PICC catheter, other catheter types can benefit from the present disclosure, including CVCs, tunneled and non-tunneled dialysis catheters, peripheral IV catheters, etc. Further, the size and length, etc., can vary from what is shown and described.
FIG. 18 shows another example of an ethanol lock indicium 340 according to one embodiment, wherein the indicium is implemented as an iconic marking 352 placed on each of the clamps 330 of the extension legs 324. In the present embodiment, the iconic marking 352 includes an image of a padlock with a letter “e” superimposed on the padlock image. The clamps 330 can optionally be colored to further indicate, as does the iconic marking 352, compatibility of the catheter with ethanol for purposes of ethanol locking, for instance and as described above. The iconic marking 352 is printed on each of the clamps 330 in the present embodiment, though other methods for placing the marking on the clamps can be employed including placement of indicia on only one extension leg to indicate ethanol compatibility for that leg and corresponding catheter lumen only.
Note that the position, design, size, content, meaning, etc. of the iconic marking can be varied from what is shown and described here. As an example of this, FIG. 19 shows the ethanol lock indicium 340 implemented as a mixed marking 362 disposed on the clamps 330. The mixed marking 362 includes both an iconic marking and an alphanumeric marking. In detail, the iconic portion of the mixed marking 362 includes the letter “e” superimposed atop an image of a padlock, as in FIG. 18. The alphanumeric portion of the mixed marking 362 includes the shorthand designation “EtOH,” similar to the embodiment of FIG. 17. This and other possible combinations of indicia are therefore contemplated.
FIG. 20 shows another example of an ethanol lock indicium 340 according to one embodiment, wherein the indicium is implemented as an alphanumeric marking 372 placed on each of the luer connectors 328 of the extension legs 324. In the present embodiment, the letters “EtOH” are printed to indicate ethanol locking capability, though other letters, words, symbols, numbers, etc., could be used to indicate ethanol compatibility or another characteristic, quality, and/or property of the medical device.
FIG. 21 shows another example of an ethanol lock indicium 340, wherein the indicium is implemented as an alphanumeric marking 382 disposed on the tube of each extension leg 324. In the present embodiment, the words “ethanol lockable” are printed to indicate ethanol locking capability, though other combinations of letters, words, symbols, numbers, colors, etc., could be used, as before.
FIG. 22 shows another example of an ethanol lock indicium 340 according to one embodiment, wherein the indicium is implemented in combination as an indicator piece 392A that is attached to or otherwise included with the catheter assembly 10, together with an alphanumeric or other suitable marking 392B included on the indicator piece. In the illustrated embodiment, the indicator piece 392A is shaped as a mini padlock indicating that the catheter assembly 10 is ethanol lockable. In addition, the alphanumeric marking 392B including an “e,” indicating ethanol lockability, is printed on the padlock-shaped indicator piece 392A. Thus it is seen that, as in this and other embodiments, multiple modes of indication, e.g., color, alphanumeric, iconic, symbolic, and shaped indicators, can be employed to convey to an observer the predetermined characteristic, quality, and/or property of the catheter or medical device. In one embodiment, all or a portion of the indicator piece can be colored, such as in yellow, for instance. Or in another embodiment, the indicator piece includes no alphanumeric or iconic marking.
Note that each of the two padlock-shaped indicator pieces 392A is slidably disposed about a corresponding one of the tubes of the extension legs 324. Though they can be fixably or movably included on other portions of the catheter assembly, it is appreciated that in one embodiment the indicator pieces 392A are such that they do not interfere with either use of the device or patient comfort or safety. Note that the size, shape, color, number, location, and design of the indicator piece(s) can vary from what is shown and described here.
FIG. 23 shows another example of an ethanol lock indicium 340 according to one embodiment, wherein the indicium is implemented in combination as an indicator piece 402A, together with an alphanumeric or other suitable marking 402B included on the indicator piece. In the illustrated embodiment, the indicator piece 402A is cylindrically shaped and hollow so as to slidably fit over one of the tubes of the extension legs 324 of the catheter 320. In addition, the alphanumeric marking 402B including the letters “EtOH,” indicating ethanol lockability, is printed on the cylindrical indicator piece 402A.
FIG. 24 shows another example of an ethanol lock indicium 340 according to one embodiment, wherein the indicium is implemented in combination as an indicator color marking 412A covering about half of each of two valved connectors 408 disposed at the ends of the extension legs 324, together with an alphanumeric marking 412B placed on each of the valved connectors atop the indicator color markings 412A. In the illustrated embodiment, the indicator color marking 412A covering half of each valved connector 408 is yellow, though other colors and the coloring of additional or alternative catheter components is possible. Note that the bifurcation is also colored yellow to serve, as in previous embodiments, as a further component of the indicium 340 to indicate ethanol compatibility. In addition, the alphanumeric marking 412B including the letters “EtOH,” also indicating ethanol lockability, is printed on the cylindrical indicator piece 402A.
FIG. 25 shows another example of an ethanol lock indicium 340 according to one embodiment, wherein the indicium is implemented as a mixed alphanumeric/iconic marking 422 placed on each of the valved connectors 408, as shown. In the illustrated embodiment, the mixed marking 422 includes the letters “EtOH,” together with an iconic padlock image including the letter “e” superimposed thereon, both indicating ethanol lockability. In contrast, FIG. 26 shows the ethanol lock indicium 340 as including only an iconic marking 432 of a padlock image including the letter “e” superimposed thereon to indicate ethanol lockability, according to yet another embodiment.
FIG. 27 shows various examples of possible ethanol locking indicia 340 according to one embodiment, including: a padlock icon with the letters “EtOH” superimposed thereon (442A); a padlock icon with a percentage concentration of ethanol to be used with the medical device (442B); a colored padlock icon, marked in the color orange here (442C); a padlock icon including a keyhole (442D); a rounded padlock icon (442E); a padlock icon including a lowercase letter “e” superimposed thereon (442F); and a padlock icon including an uppercase letter “E” superimposed thereon (442G). Note these and the other markings and indicia discussed herein can be included with the catheter or medical device in any one of a variety of ways including an adhesive or other decal or skin, ink-printed, a physical piece, etc., and can be applied to any suitable portion of the device or component closely associated therewith via any suitable method, including direct surface application, pad printing, embossing, insert molding, over molding, etc.
FIG. 28 shows another example of an ethanol lock indicium 340 according to one embodiment, wherein the indicium is implemented as an iconic marking 452 that includes a padlock image including the letter “e” superimposed thereon to indicate ethanol lockability. In the present embodiment, the marking 452 is defined in a body 448 of a radiopaque insert 446 that is in turn included with an implantable access port. In one embodiment the insert 446 is relatively thin and sheet-like and includes a mixture of acetyl resin and bismuth trioxide, though many other suitable materials can be used to define the insert. The marking 452 in the present embodiment is defined as a cut-out through the sheet-like insert body 448 such that it provides a contrast to the insert body when viewed via x-ray imaging technology after the access port has been implanted into the body of the patient. Also optionally included on the insert 446 is a power injection indicium 450, indicating suitability of the port for power injection of contrast media or other fluids therethrough. Further details regarding the radiopaque insert and associated access port can be found in U.S. Pat. No. 8,029,482, filed Jun. 8, 2010, and entitled “Systems and Methods for Radiographically Identifying an Access Port,” which is incorporated herein by reference in its entirety. Note that the size, shape, and configuration of the insert can vary from what is shown and described herein. Note also that the type, size, configuration, purpose etc., of the ethanol lock indicium can also vary.
In light of the above, in one embodiment it is appreciated that the indicia discussed herein can be included with a component that is employed or associated with the medical device rather than applied to the medical device itself. This includes inclusion of the indicia on a luer cap or needle-less injection cap, for instance, each of which operably connects to the luer connectors of the catheter. As such, any one or more of the indicia spoken above can be associated with such caps or other components employed with the catheter or other medical device. In one embodiment, it is further appreciated that the indicia can be formed so as to be radiopaque, thus enabling detection via x-ray imaging technology.
It is appreciated that, in light of the above, the indicia described herein can be implemented in other ways, for other purposes than indicating ethanol locking capability, and for other devices in addition to catheter assemblies. The above embodiments should therefore not be considered limiting in any way.
The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative, not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

## Claims

1. A medical device for at least partial insertion into a patient, the medical device comprising:
a peripherally-inserted central catheter;
a device body; and
at least one ethanol indicium included with the device body, the at least one ethanol indicium perceptible by an observer to indicate a compatibility of the medical device with ethanol or other alcohol-based substance, wherein the at least one ethanol indicium includes at least one of an iconic marking including a symbol indicative of a lock and an alphanumeric marking indicative of the word “ethanol”.

2. The medical device as defined in claim 1, wherein the at least one ethanol indicium is visually perceptible by the observer.

3. The medical device as defined in claim 1, wherein the medical device includes the catheter defining at least one lumen and wherein compatibility of the catheter indicates that ethanol can be disposed within the at least one lumen of the catheter without compromise to the functionality of the catheter.

4. The medical device as defined in claim 3, wherein the at least one ethanol indicium includes a coloring included on a bifurcation.

5. The medical device as defined in claim 4, wherein the coloring is substantially yellow and wherein the coloring is further included on at least one additional component of the catheter.

6. The medical device as defined in claim 1, wherein the iconic marking includes a padlock image.

7. The medical device as defined in claim 1, wherein the at least one ethanol indicium includes shorthand indication for the word “ethanol”.

8. The medical device as defined in claim 1, wherein the at least one ethanol indicium includes a discrete indicator piece that is slidably attached to a portion of the catheter.

9. The medical device as defined in claim 8, wherein the discrete indicator piece is slidably attached to an extension leg of the catheter.

10. The medical device as defined in claim 9, wherein the discrete indicator piece is one of a cylindrical shape and a padlock shape.

11. The medical device as defined in claim 1, wherein the at least one ethanol indicium is disposed on a luer connector of the catheter.

12. The medical device as defined in claim 1, wherein the at least one ethanol indicium indicates a percentage concentration of ethanol that the medical device can be acceptably exposed to.

13. The medical device as defined in claim 1, wherein the at least one ethanol indicium is included on a tube clamp of an extension tube of the medical device.

14. A catheter for accessing an internal portion of a patient, comprising:
a peripherally-inserted central catheter;
a catheter tube defining at least one lumen; and
at least one ethanol indicium included with the catheter, the at least one ethanol indicium perceptible by an observer to indicate a compatibility of the catheter with ethanol; wherein the catheter further includes at least one extension leg operably attached to the catheter tube via a colored bifurcation, the colored bifurcation substantially colored yellow to serve as the at least one ethanol indicium; wherein each extension leg further includes a tube clamp, at least one tube clamp being colored and further including an alphanumeric marking to also serve as the at least one ethanol indicium; and wherein the alphanumeric marking includes the letters “ETOH” to indicate that the catheter can be fluid locked with ethanol.