# Patent

## Title
Resource information key for an insertable medical device

## 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 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.

## Background
CROSS-REFERENCE TO RELATED APPLICATION
This application claims the benefit of the U.S. Provisional Patent Application No. 60/864,806, filed Nov. 8, 2006, and entitled “Medical Device Uniform Resource Identifier,” which is incorporated herein by reference in its entirety.


TECHNOLOGY FIELD
The present invention generally relates to medical devices insertable into the body of a patient. In particular, embodiments of the present invention relate to a system by which a key for directing a user to resource information relating to the medical device is included on the device in a manner that enables the resource information to be readily accessed.
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, and other devices designed to enable intravascular 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.
The present invention has been developed in response to the above and other needs in the art. Briefly summarized, embodiments of the present invention 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.
These and other features 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; and
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.



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.
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, thus 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.
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. An insertable medical device for establishing intravascular access to a patient, wherein the insertable medical device is a peripherally inserted central catheter access line comprising:
an internal portion including a catheter configured for intravascular insertion into the patient; and
an external portion configured to remain outside of the patient, the external portion of the peripherally inserted central catheter access line including a resource information key visibly positioned at a predetermined key location on the external portion, the resource information key indicating a Uniform Resource Locator.

2. The peripherally inserted central catheter access line as defined in claim 1, wherein the key location is disposed on at least one of the following components of the peripherally inserted central catheter access line: an extension tube, a connector, a clamp, a hub, and a proximal portion of the catheter.

3. The peripherally inserted central catheter access line as defined in claim 1, wherein the resource information key is positioned on the external portion via one of etching, embossing, labeling, or printing with ink.

4. The peripherally inserted central catheter access line as defined in claim 1, wherein the resource information key is disposed on an attachable component positioned on the external portion.

5. The peripherally inserted central catheter access line as defined in claim 1, further comprising a catheter stabilization device configured to secure the peripherally inserted central catheter access line in place following insertion of the internal portion into the patient, wherein the resource information key is additionally positioned at one or more locations on the catheter stabilization device.

6. The peripherally inserted central catheter access line as defined in claim 1, further comprising an adhesive dressing configured to cover a portion of the peripherally inserted central catheter access line following insertion of the internal portion into the patient, wherein the resource information key is additionally positioned at one or more locations on the adhesive dressing.