MX2014011280A - Indicia informative of characteristics of insertable medical devices. - Google Patents

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.

Description

DISTINCTIVE BRANDS OF THE CHARACTERISTICS OF THE INSERTABLE MEDICAL DEVICES BRIEF SUMMARY Manufacturers of medical devices, including those that are configured for insertion into the body of a patient, generally do everything possible to ensure that each device is accompanied by a large collection of printed material and others intended to ensure that the device is placed and used correctly. Examples of such devices include peripherally inserted central catheters (PICC), dialysis catheters, peripheral catheters, central venous catheters (CVC), access ports and other devices designed to provide vascular access to the patient.

Despite the efforts mentioned above, however, situations may arise where more information about a particular medical device is desired or necessary, so that the device is used properly. For example, the documentation that accompanies the medical device may be misplaced or misplaced, or more information may be issued after the device was manufactured and distributed. Such information may be needed by the practitioner who places the medical device on the patient, or by the patient or caregiver after the device is inserted. In these or other cases, it may be difficult for the practitioner, the patient, or caregiver to easily acquire the necessary information related to the device.

In light of the above discussion, therefore, there is a need for a solution that overcomes the challenges identified above in relation to the availability of medical device information for the insertable medical devices.

The embodiments of the present invention are developed in response to the above and other needs in the matter. Briefly summarized, these modalities are directed to a system by which the information resource related to an insertable medical device, such as an intravascular catheter, can be identified by its source with the purpose of being accessed by a physician, caregiver or patient. Particularly, a resource information key is included in a predetermined key location in or next to the medical device, where the key indicates the source of the resource information.

In an exemplary embodiment, therefore, an insertable medical device is described for establishing intravascular access to a patient, such as a peripherally inserted central catheter (PICC), and comprises: an internal portion that is configured for intravascular insertion in the patient, and a portion external to the patient. The outer portion of the PICC includes a resource information key that is placed in a predetermined key location. The resource information key indicates a website where the user can acquire the resource information related to the medical device.

In other modalities, an insertable medical device includes a a two-dimensional code, such as a fast response code (QR) that is electronically readable for the purpose of providing information about a characteristic or other aspect of the medical device to a user or other person. In still other embodiments, various distinguishing marks are disclosed to indicate to a user a particular feature of the medical device, such as its compatibility with respect to ethanol and other alcohol-based liquids.

These and other features of the embodiments of the present invention will become fully apparent from the following description and appended claims, or may be learned by practice of the invention which are set forth in the present description hereinafter.

BRIEF DESCRIPTION OF THE FIGURES To further elucidate the foregoing and other advantages and features of the present invention, a more particular description of the invention will be represented with reference to specific embodiments thereof that are illustrated in the appended figures. It is appreciated that these figures represent only typical embodiments of the invention and, therefore, are not considered to limit its scope. The invention will be described and explained with specificity and additional detail through the use of the accompanying figures, in which: FIG. 1 is a top view of a central peripheral insertion catheter (PICC) partially inserted into the arm of a patient, which represents, therefore, an example of an insertable medical device that benefits from the present invention in accordance with one modality of this; Fig. 2 is a perspective view of the PICC of Fig. 1 before insertion into a patient, including a resource information key according to a modality; Fig. 3 is a close-up top view of a portion of the PICC of Fig. 2, showing additional details of the resource information key; Fig. 4 is a top view of a portion of the PICC connector of Fig. 2, showing a location of the resource information key according to a modality; Fig. 5 is a top view of a clamp portion of the PICC of Fig. 2, showing a location of the resource information key according to a modality; Fig. 6 is a top view of a branch hub portion of the PICC of Fig. 2, showing a location of the resource information key according to a modality; Fig. 7 is a top view of a catheter portion of the PICC of Fig. 2, showing a location of the resource information key according to a modality; Fig. 8 is a top view of a portion of the PICC of Fig. 2, including a hanging tag having a location of the resource information key according to a mode; 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 a stabilization device together with a dressing, having a plurality of resource information key locations according to an embodiment of the present invention; Fig. 1 1 is a perspective view of an implantable double-septum access port, representing an example of an implantable medical device benefiting from the present invention according to one embodiment thereof; Fig. 12 is a bottom view of the double-baffle implantable access port of Fig. 11, which includes an inverted radiopaque resource information key according to an embodiment of the present invention; Fig. 13A is a perspective view of a catheter unit including a distinctive mark encoded according to one embodiment; Fig. 13B shows a QR code example as a distinctive mark encoded according to one modality; Fig. 14 is a top view of the bifurcation of the catheter unit of Fig. 13A, showing the coded distinctive mark; Fig. 15 is a perspective view of an access port including a distinctive mark coded according to one embodiment; Fig. 16 is a top view of an access port including a coded distinguishing mark included in a partition of this agreement with a modality; Fig. 17 is a perspective view of a portion of a catheter unit including certain distinguishing marks according to one embodiment; FIG. 18 is a perspective view of a portion of a catheter unit including certain distinguishing marks according to one embodiment; Fig. 19 is a perspective view of a portion of a catheter unit including certain distinctive marks according to one embodiment; Fig. 20 is a perspective view of a portion of a catheter unit including certain distinguishing marks according to one embodiment; Fig. 21 is a perspective view of a portion of a catheter unit including certain distinguishing marks according to one embodiment; FIG. 22 is a perspective view of a portion of a catheter unit including certain distinguishing marks according to one embodiment; Fig. 23 is a perspective view of a portion of a catheter unit including certain distinguishing marks according to one embodiment; FIG. 24 is a perspective view of a portion of a catheter unit including certain distinguishing marks according to one embodiment; Fig. 25 is a perspective view of a portion of a catheter unit including certain distinguishing marks according to one embodiment; Fig. 26 is a perspective view of a portion of a catheter unit including certain distinguishing marks according to one embodiment; Fig. 27 shows various symbols that can serve as distinctive marks according to one embodiment; Y Fig. 28 is a bottom view of a radiopaque accessory for use with an implantable port that includes certain distinguishing marks according to a modality.

DETAILED DESCRIPTION OF THE SELECTED MODALITIES Reference will now be made to the figures in which similar structures will be provided with similar reference designations. It is understood that the figures are diagrammatic and schematic representations of illustrative embodiments of the invention, and are not limiting of the present invention nor necessarily drawn to scale.

I. Resource information key.

Figs. 1-10 illustrate various feature characteristics of the present invention, which is generally directed to a system by which the resource information related to an insertable medical device, such as an intravascular catheter device, can be identified with the purpose that is accessed by a doctor, caregiver or patient.

Reference is first made to Fig. 1, which represents a medical device, which is designated, generally, at 10, which is configured to be inserted into a body 12 of a patient. Particularly, the medical device 10 depicted in FIG. 1 is a centrally inserted double lumen peripheral catheter (PICC) and is shown inserted into the arm of the patient's body 12. In addition, Fig. 1 shows a location of the resource information key, which is described in more detail below, generally indicated at 50.

It should be noted that, although the appended figures represent a PICC device, other medical devices that are inserted at least partially in the patient they may also benefit from the principles of the present invention which is described in the present description. Examples of such devices include dialysis catheters, peripheral catheters, cannulas, infusion sets, and other devices designed to allow intravascular access to the patient. In still other embodiments, fully implantable devices, such as subcutaneous access ports may also use embodiments of the present invention. As such, the breadth of the present invention should not be construed as limited to the medical devices that are explicitly depicted and described in the present disclosure.

Reference is now made to Fig. 2, which depicts in greater detail the PICC shown in Fig. 1 before placement in a patient, which is shown here in 20. The comparison of Fig. 2 with Fig. 1 will disclose that PICC 20 includes an inner portion 20A to be inserted into the vasculature of a patient and an outer portion 20B that remains outside the patient's body during use of the PICC. As the embodiments of the present invention can be applied to other insertable medical devices, the internal and external portions of other devices can be varied according to the particular design of the medical device. As shown, the PICC 20 generally includes a catheter 22, an extension leg unit 24, and a bifurcation hub 26 operatively interconnecting the catheter to the extension leg unit.

In more detail, the extension leg unit 24 is configured to allow the infusion or aspiration of fluids into or from the patient's vasculature via the catheter 22 and the bifurcation hub 26. The extension leg 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 in the first extension tube 40, and a second clamp 46 is included in the second extension tube 42. It should be noted that more or less extension tubes could be included with the PICC 20.

According to one embodiment, a key is provided with the PICC 20 to allow more information related to the PICC to be accessed by a patient, practitioner, caregiver, etc. Specifically, a location of the resource information key (RIKL) which is indicated, generally, at 50, is provided in the PICC 20. The RIKL 50 defines an area of the PICC 20, where a resource information key is located. 52. As will be described, the resource information key 52 provides data to one as well as to a source, where more information about the PICC 20 can be accessed. This does not provide the information itself, instead it acts as a "key". ", which allows locating more information related to the PICC.

The content of the resource information key 52 can be any alpha-numeric, typographical, graphic or other visual distinguishing marks that can visually convey to the user the source where to find more information about the medical device. Letters, numbers, graphs or other symbols, etc., may be used as such or in combination to form the resource information key 52. In yet another modality, the key can not be identified visually, but rather by palpation.

For example, and as shown in greater detail in Fig. 3, the resource information key 52 in a modality is implemented as a uniform web resource locator (URL), www.powerpicc.com. where the user can access through the various Internet web pages that give more information about the structure, use, precautions, or other aspects related to the PICC 20. Such information may be beneficial to the user, or may be critical to in order to ensure patient safety, especially in cases where the printed material that originally accompanied the IPCC 20 is lost or lost, or when new information about the PICC is available.

In light of the above discussion, it will be appreciated that, according to embodiments of the present invention, the resource information key 52 may take one of several forms, especially with respect to directing the user to an Internet-based resource. Examples of a resource information key include, as such, a web address, URL, URI, IP address, etc., which in turn direct the user to a website, where additional information can be found. Of course, the content of the resource information key 52 can be varied according to the device in which it is located.

As shown in Figs. 2 and 3, the resource information key 52 is included in the RIKL 50, which in turn is disposed in a portion of the second extension tube 42. Generally, the RIKL 50 is chosen so that it is easily visible by the user. The RIKL 50 should also be large enough so that the resource information key 52 can be read without undue effort. Generally, the locations that are disposed proximally in the outer portion of the medical device are advantageous for the purpose of allowing the key to be easily seen. However, as will be seen in the additional example modalities discussed below, the key can be located in a variety of locations in the medical device. The resource information key 52 can be defined in the RIKL 50 in a variety of ways, including embossing, labeling, ink or other printing, etc.

As mentioned, the resource location key, although it is located in the second extension tube 42 in the modalities shown in Figs. 1-3, in other modalities it can be placed in other resource information key locations in the PICC or other insertable medical device. Figs. 4-8 give several examples of this type of alternative placement locations for the resource information key. In Fig. 4, for example, the RIKL 50 is arranged in the first connector 30 of the extension leg unit 24, while Fig. 5 shows the RIKL which is arranged on a cover 56 which is fixed 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 may be arranged on one or both of two suture wings 60 extending from the body of the bifurcation hub 26. In Fig. 7, RIKL 50 is disposed in a proximal portion 22A of catheter 22 that is not inserted into the patient. In Fig. 8, a hanging tag 80 or other dockable component can be added to the PICC 20 to include the RIKL 50 on it.

The embodiments shown in Figs. 1-8 show the RIKL 50 that is available in a portion of the PICC 20 itself. However, the RIKL it can also be positioned on a component that is not part but is 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 help secure the PICC 20 in place after insertion into the patient's vasculature. . The stabilization device 90 includes a base 92 and a retention unit 94 for retaining the branch concentrator 26 of the PICC 20. The retention unit 94 selectively includes closable covers 96. Fig. 9 further shows two possible areas for the RIKL 50: in a portion of the base of the device 92, and in one or both of the covers 96. Other areas could, of course, be used in the stabilization device 90 to place the RIKL 50.

Fig. 10 shows an adhesive dressing 100 which is commonly used to cover a portion of the PICC 20 and the stabilization device 90 for greater hygiene. The apposite 100 here includes two RIKL 50 as one more example of the possible locations for the placement of the resource information key. It is appreciated that if desired, in addition to the examples discussed above, many other key locations could be conceived in a variety of insertable medical devices, including devices that are fully implanted in the patient's body, such as access ports. . The present invention should not, therefore, be limited to only what is explicitly shown and described in the present description.

Figs. 1 1 and 12 illustrate the present invention as used in another embodiment. Particularly, Figs. 1 1 and 12 represent a port of double partition access 110 that is configured for subcutaneous implantation in the body of a patient. The access port 1 10 includes a first partition 1 12 covering a first tank, and a second partition 1 14 covering a second tank. The deposits are defined by a body 16. The resource information key 52 is arranged at a predetermined resource information key location 50 on a lower surface 18 of the access port body 16.

The key 52 in Fig. 12, "www.bardpp.com". it is placed on the lower surface 118 in a reverse configuration, or mirror image. In addition, the material that is used to define the key 52 includes a radiopaque material such that the key 52 is visible when a radiographic image, or x-ray, is taken from the implanted access port 110. The reverse key 52 in this case will appear Reverse when the x-ray image is viewed, which allows the orientation of the implanted access port to be easily checked. Of course, the key can be placed in any of a variety of configurations, inverse or not, and locations in the access port.

The content of the key 52 can also serve, if desired, to identify the access port 1 10 in terms of type, size, manufacturer, etc. Additionally, the key 52 provides a source to which an observer can go to access more information about the access port 1 10, as in the previous modalities. It must be taken into account that, while shown here in relation to a double-partition access port, a single partition or access ports that are configured in any other way, as well as other types of implantable medical devices, they can also benefit from the principles described herein with respect to this modality.

II. Coded distinctive mark v related to ethanol Reference is now made to Figs. 13A-14 in the description of the details of the identification of distinguishing marks for a medical device according to a modality. As shown, Fig. 13A depicts a medical device, specifically a catheter 120, which generally includes a distal portion 120A and a proximal portion 120B. In detail, catheter 120 includes a catheter tube 222 that defines one or more lumens. The catheter tube 222 defines two lumens, although the number of lumens may vary. Each of two extension legs 224 of the catheter 120 is in fluid communication with one of the respective 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 at the proximal ends of extension legs 224. In addition, clamps 230 are provided on extension legs 224 to allow selective occlusion of these.

According to the present embodiment, a coded distinguishing mark 240 is included with the medical device shown here, ie, the catheter 120. The coded distinguishing mark 240 is configured to provide information related to a characteristic, property, and / or the quality of catheter 120 or other medical device with which it is associated. For example, the coded distinctive mark 240 may be used to access an Internet page or online resources, with an appropriate Internet or web browser, such as those found in smartphones, laptops, devices connected to the Internet, etc., with the purpose of allowing the user to acquire more information about the catheter 120.

Examples of resources to which the coded distinctive mark 240 can be directed by a user include: a web page giving further details and / or instructions about the medical device; visual and / or multimedia information, which includes videos that describe and demonstrate the use of the medical device; instructional websites that direct the user on how to insert, remove and / or use the medical device; identification information about the medical device that includes the type, size, manufacturer, etc .; warnings or official information promulgated by the manufacturer or by an official or regulatory body; recently issued or published information about the medical device, etc. These and other resources and information may be the objectives to which a user is directed by the distinctive coded mark 240.

In the present embodiment, the coded distinguishing mark 240 is implemented as a two-dimensional coded symbol, such as a fast response code (QR) 242. Specifically, and as shown in Figs. 13A and 14, the QR code 242 is a two-dimensional array barcode and is included in an upper portion of the branch 226, a portion of the proximal portion 120B of the catheter 120. A relatively larger view of the QR code 242 is shown in FIG. shows in Fig. 13B. It should be noted that the QR code 242 can be included in a suitable place in the catheter 120, in addition to what is shown in Fig. 13A, which includes the placement of any of the components shown in Fig. 13A. The QR code 242 may be added to catheter 120 by the use of any acceptable method, including printing, adhesive labeling, engraving, embossing, insert molding, etc. Additionally, the QR code 242 can be included in the appropriate medical devices for the purpose of being radiopaque, which allows the identification of the medical device by means of x-ray imaging technology. In addition, other two-dimensional coded symbols, in addition to the QR codes may be included in the medical device to serve as a coded distinctive mark, as appreciated by one skilled in the art. In the same way, the size and particular configuration of the QR code may vary from what is shown here.

The QR code 242 is encoded for the purpose of being electronically scannable, also referred to in the present description as machine readable or optically scannable, such that a device configured to scan and interpret QR codes can visually read the code QR and access the resource or information associated with it for the presentation to the user. An example of such a device is a smart phone with a camera that can take a photo or otherwise scan electronically (such as by means of an optical scanner) the QR code 242, then access the Internet or another portal for the purpose of recovering the resource or information with which the QR code is associated before presenting the resource or information to a user, such as on a smartphone screen. Smartphones and other electronic devices commonly include, or may be modified to include, software or appropriate applications that allow for imaging and interpreting QR codes and other scannable codes. In another modality, a A special purpose computer or portable 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, catheter 120 including the coded distinguishing mark 240 as seen in Fig. 13, can be inserted into a patient for the purpose of establishing vascular access. Before or after insertion of the catheter 120, the user can electronically scan the QR code 242 with a smartphone or other suitable scanning device that includes the corresponding software or application. Once the QR code 242 is 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 the information associated with the QR code. The resource / information may include instructions for flushing the catheter 120, for example. The resource and / or information will be displayed on the smartphone screen, allowing the user to read and use the information.

As mentioned, various other types of devices can be used to scan, interpret and present to the user the information associated with the QR code. In addition, in addition to accessing information remotely via the Internet or another source, other means of acquiring information associated with the QR code can be used, including access to information that is located locally on the smartphone or other device. of scanning itself.

Figs. 15 and 16 show the placement of QR code 242 according to other modalities. In Fig. 15, an access port is shown 260, which includes a body 262 and an attached partition 264. From the port body 262 a shank 266 extends. The QR code 242 is shown in this embodiment located on a lateral side of the port body 262, where it can be scanned before placing the access port 260 in the body of a patient to access the corresponding information. In Fig. 16, the QR code 242 is placed on the partition 264. In one embodiment, the QR code 242 of Fig. 16 can be configured to be radiopaque for the purpose of allowing the identification of the access port 260 using the code QR 242 after the port is implanted subcutaneously inside the body of a patient. Therefore, it is appreciated that the use of the QR code is contemplated to facilitate the acquisition of more resources / information about one of a variety of medical devices.

Reference is now made to Fig. 17 in the description of a medical device according to another embodiment. Particularly, FIG. 17 shows a catheter 320 that includes an elongated catheter tube 322 that defines two lumens, although other configurations of the lumens are also possible. A proximal end of the catheter tube 322 is operatively joined to a branch 326. A proximal end of the bifurcation 326 is operatively joined to two extension legs 324, each defining a lumen such that a fluid path is defined between each extension leg and the corresponding lumen of the catheter tube 322. More or fewer extension legs may be included according to the design of the catheter. Each extension leg 324 includes a corresponding Luer connector 328. A clamp 330 is also optionally included in each extension leg 324.

According to the present embodiment, several distinguishing marks are included with the catheter unit or other medical device for an observer a predetermined characteristic, quality, property, or other aspect of the catheter unit. In the embodiments described below, the predetermined characteristic includes compatibility of the catheter with alcohol-based solutions such as ethanol, for example, the ability of ethanol to be disposed within the catheter or the lumens of the extension leg for a period of time. of time for the purpose of "blocking" (also referred to herein as "ethanol blocking") the catheter and preventing coagulation, layering, and / or occlusion at or near the tip of the catheter. The use of ethanol to block the lumen (s) of a catheter lumen is also useful for the prevention and treatment of catheter infection. "Ethanol compatibility" and "ethanol blocking" are used in the present disclosure 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 a ) without unacceptably degrading the catheter / device. In addition to indicating compatibility with ethanol, the distinguishing marks to be described below may indicate other characteristics, qualities or properties of the catheter or medical device. Therefore, the discussion that follows should not be considered limiting in any way.

In light of the foregoing, FIG. 17 shows a distinctive ethanol blocking mark ("distinguishing mark" or "distinguishing marks") 340, according to one embodiment, to indicate compatibility with ethanol of catheter 10, which includes the capacity of the catheter to be blocked with a solution containing liquid ethanol. As shown, the distinguishing mark 340 in the present embodiment is it implements as a indicator color 342A which is applied to the bifurcation 326 of the catheter 320 in combination with an alphanumeric marking 342B which is included in the clamps 330 of the extension leg 324.

In more detail, indicator color 342A of the bifurcation indicates to an observer in the present embodiment that the catheter unit can be blocked with ethanol. This indication is important, since not all catheter units are adequate or can adequately support the presence of ethanol. In the present embodiment, indicator color 342A which is disposed at branch 326 is yellow, although other colors may also be used to indicate this or another characteristic, quality, or property of the catheter / medical device. Additionally, in this embodiment, the clamps 330 are also yellow in color to indicate compatibility with ethanol. More, less, 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 distinctive mark 340, in combination with the indicator color of the branch 342A. As shown in Fig. 17, the alphanumeric marking 342B is disposed on each of the clamps 330 and includes an alphanumeric message, specifically "EtOH", an abbreviated designation of ethanol. This indicates to an observer the compatibility of catheter 320 with ethanol.

In one embodiment, one or more of the catheter tube 322, the bifurcation 326, and the extension legs 324 include an ethanol-resistant material, such as an aromatic polycarbonate polyurethane that is further classified to withstand typical power injection pressures of approximately 190 psi. Other suitable plastics may also be used, including aromatic polyether, aliphatic polycarbonate, and aliphatic polyether polyurethanes. In one embodiment, an ethanol solution of about 70% concentration is used in blocking the catheter 320, although other concentrations and formulations may be used and indicated by the distinguishing mark.

It is appreciated that the indicator color and the alphanumeric mark included in the ethanol blocking indicia of the present embodiment can be used together or separately, placed in different parts or components of the catheter or medical device, and can be configured differently , as discussed later. In addition, as mentioned, the distinguishing mark can be used to indicate other characteristics, qualities and / or properties of the catheter or medical device. In the case of catheters, although the present figures show a PICC catheter, other types of catheters may benefit from the present disclosure, which include CVCs, tunneled and non-tunneled dialysis catheters, peripheral IV catheters, etc. In addition, the size and length, etc., may vary from what is shown and described.

Fig. 18 shows another example of a distinctive ethanol blocking mark 340 according to one embodiment, wherein the distinguishing mark is implemented as a tapered mark 352 which is placed on each of the clamps 330 of the legs of extension 324. In the present embodiment, conic mark 352 includes an image of a padlock with a letter "e" superimposed on the image of the padlock. The clamps 330 may optionally be colored to further indicate, as well as the tapered mark 352, the compatibility of the catheter with ethanol for purposes of ethanol blocking, for example and as described above. The conical mark 352 is printed on each of the clamps 330 in the present embodiment, although other methods for placing the mark on the clamps can be used which include the placement of signs on a single extension leg to indicate ethanol compatibility for that leg and the corresponding catheter lumen only.

It must be taken into account that the position, design, size, content, meaning, etc. The conical brand may vary from what is shown and described here. As an example of this, FIG. 19 shows the distinctive ethanol blocking mark 340 which is implemented as a mixed mark 362 which is disposed on the clamps 330. The mixed mark 362 includes both a conical mark and an alphanumeric mark. In detail, the conic portion of the mixed mark 362 includes the letter "e" superimposed on top of an image of a padlock, as in Fig. 18. The alphanumeric portion of the mixed mark 362 includes the abbreviated designation "EtOH", similar to the modality of Fig. 17. Therefore, this and other possible combinations of distinctive marks are contemplated.

FIG. 20 shows another example of a distinctive ethanol blocking mark 340 according to one embodiment, wherein the distinguishing mark is implemented as an alphanumeric mark 372 that is placed on each of the Luer 328 connectors of the extension legs. 324. In this modality, the letters "EtOH" are printed to indicate the ethanol blocking capacity, although other letters, words, symbols, numbers, etc. could be used to indicate compatibility with ethanol or another characteristic, quality and / or property of the medical device.

Fig. 21 shows another example of a distinctive ethanol blocking mark 340, wherein the distinguishing mark is implemented as an alphanumeric mark 382 that is disposed on the tube of each extension leg 324. In the present embodiment, the words " "Ethanol lockable" are printed to indicate ethanol blocking capacity, although other combinations of letters, words, symbols, numbers, colors, etc., could be used as before.

Fig. 22 shows another example of a distinctive ethanol blocking mark 340 according to one embodiment, wherein the distinctive mark is implemented in combination as an indicator piece 392A that is attached or otherwise included in the catheter unit 10, along with an alphanumeric or other appropriate 392B mark that is included in the indicator piece. In the modality illustrated, the indicator piece 392A is in the form of a minicand indicating that the catheter unit 10 is lockable to ethanol. In addition, the alphanumeric marking 392B including an "e", which indicates ethanol blocking capacity, is printed on the indicator piece 392A in the form of a padlock. Thus it is noted that, as in this and other modalities, multiple modes of indication, eg, color, alphanumeric, conical, symbolic, and molded indicators, may be used to convey to an observer the characteristic, quality and / or predetermined property. of the catheter or medical device. In one embodiment, all or a portion of the indicator piece may be colored, such as, for example, yellow. Or in another mode, the indicator piece does not include an alphanumeric or iconic mark.

It should be noted that each of the two indicator pieces in the form of a padlock 392A is slidably disposed on one of the corresponding tubes of the extension legs 324. Although they can be included fixedly or movably in other portions of In the catheter unit, it will be appreciated that in one embodiment, the indicator pieces 392A are such that they do not interfere with either the use of the device or the comfort or safety of the patient. It should be noted that the size, shape, color, number, location and design of the indicator piece (s) may vary from what is shown and described here.

Fig. 23 shows another example of a distinctive ethanol lock mark 340 according to one embodiment, wherein the distinguishing mark 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 embodiment illustrated, the indicator piece 402A is cylindrical and hollow so as to fit slidably on one of the tubes of the extension legs 324 of the catheter 320. Additionally, the alphanumeric marking 402B that includes the letters "EtOH", which indicates the ability to block ethanol, is printed on the cylindrical indicator piece 402A.

FIG. 24 shows another example of a distinctive ethanol blocking mark 340 according to one embodiment, wherein the distinguishing mark is implemented in combination as a 412A indicator color mark covering approximately half of each of two connectors with valves 408 that are disposed at the ends of the extension legs 324, together with an alphanumeric marking 412B placed on each of the valve connectors on top of the 412A indicator color markings. In the embodiment illustrated, the indicator color mark 412A covering half of each valve connector 408 is yellow, although other colors and coloration of the additional or alternative catheter components are possible. It should be noted that the bifurcation is also yellow in color to serve, as in the above embodiments, as an additional component of the distinguishing mark 340 to indicate compatibility with ethanol. Additionally, the alphanumeric marking 4 2B which includes the letters "EtOH", which also indicates capacity to block ethanol, is printed on the cylindrical indicator piece 402A.

Fig. 25 shows another example of a distinctive ethanol blocking mark 340 according to one embodiment, wherein the distinguishing mark is implemented as an alphanumeric / iconic mixed mark 422 that is placed on each of the valve connectors 408, as shown. In the embodiment illustrated, the mixed mark 422 includes the letters "EtOH", together in a conical padlock image that includes the letter "e" superimposed on it, both of which indicate ethanol blocking capacity. In contrast, Fig. 26 shows the distinctive ethanol blocking marker 340 that includes only an iconic mark 432 of an image of a padlock that includes the letter "e" superimposed on it to indicate ethanol blocking capacity, in accordance with another modality Fig. 27 shows various examples of possible distinctive ethanol blocking marks 340 according to one embodiment, including: a padlock icon with the letters "EtOH" superimposed on it (442A); a padlock icon with a percentage concentration of ethanol to be used with the medical device (442B); a colored padlock icon, marked here in orange (442C); a padlock icon that includes a keyhole (442D); a rounded padlock icon (442E); a padlock icon that includes a lowercase letter "e" superimposed on it (442F); and a padlock icon that includes a capital letter "E" superimposed on it (442G). It should be noted that these and the other distinguishing marks and markings described in the present description may be included with the catheter or medical device in any of a variety of ways, including an adhesive or other label or skin, printed in ink, a physical part, etc., and can be applied to any suitable portion of the device or component closely associated therewith by any suitable method, including direct application to the surface, pad printing, embossing, insert molding, over molding, etc.

Fig. 28 shows another example of a distinctive ethanol blocking mark 340 according to one embodiment, wherein the distinguishing mark is implemented as a conical mark 452 that includes an image of a padlock that includes the letter "e" superimposed over this to indicate the ability to block ethanol. In the present embodiment, the mark 452 is defined in a body 448 of a radiopaque insert 446 that is itself included in an implantable access port. In one embodiment, insert 446 is relatively thin and sheet-like including a mixture of acetyl resin and bismuth trioxide, although many other suitable materials can be used to define the insert. The mark 452 in the present embodiment is defined as a cut through the insert body in the form of sheet 448, in such a way that it provides a contrast with the insert body when viewed by the x-ray imaging technology after which the access port is implanted in the patient's body. In addition, optionally included in the insert 446 is a distinctive power injection mark 450, which indicates the suitability of the port for power injection of the contrast media or other fluids therethrough. More details about the radiopaque insert and the associated access port can be found in U.S. Pat. 8,029,482, filed June 8, 2010, and entitled "Systems and Methods for Radiographically Identifying an Access Port", which is incorporated herein by reference in its entirety. It should be noted that the size, shape, and configuration of the insert may vary from what is shown and described in the present description. It should also be borne in mind that the type, size, configuration, purpose, etc., of the distinctive ethanol blocking mark may also vary.

In light of the above, in one embodiment it is appreciated that the distinguishing marks discussed in the present description may be included with a component that is used or associated with the medical device instead of being applied to the medical device itself. This includes the inclusion of the distinctive markings in a Luer plug or needleless injection cap, for example, each of which is operatively connected to the Luer connectors of the catheter. As such, any one or more of the distinguishing marks discussed above may be associated with such caps or other components that are used with the catheter or other medical device. In one embodiment, it will also be appreciated that distinctive marks can be formed for the purpose of being radiopaque, thus enabling detection by x-ray imaging technology.

It is appreciated that, in light of the foregoing, the markings described herein may be implemented in other ways, for other purposes besides indicating the ethanol blocking capacity, and for other devices in addition to the catheter units. The above modalities should therefore not be considered as limiting in any way.

The present invention can be realized in other specific forms without departing from its spirit or essential characteristics. The modalities that are described are considered in all aspects 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 fall within the meaning and range of equivalency of the claims are understood within its scope.

Claims (31)

1. A medical device for inserting, at least partially, into a patient; The medical device comprises: a body; Y At least one distinguishing mark encoded in two dimensions that is included in the body, the coded distinguishing mark is optically scannable to allow access to the information related to at least one characteristic, property, and / or quality of the medical device.

2. The medical device as defined in claim 1, further characterized in that at least the two dimensional coded distinguishing mark includes a bar code.

3. The medical device as defined in claim 1, further characterized in that at least one distinctive mark encoded two-dimensionally includes a rapid response code (QR) that is disposed in the body of the medical device.

4. The medical device as defined in claim 1, further characterized in that at least one distinctive two-dimensional coded mark is optically scanned by a scanning device that includes a camera or optical sensor.

5. The medical device as defined in claim 4, further characterized in that at least one distinctive mark encoded two-dimensionally is optically scanned by a camera of a telephone intelligent.

6. The medical device as defined in claim 4, further characterized in that information related to at least one characteristic, property, or quality of the medical device is accessed via the Internet by the scanning device.

7. The medical device as defined in claim 6, further characterized in that the information is represented on a screen of the scanning device.

8. The medical device as defined in claim 3, further characterized in that the medical device is a catheter, and further characterized in that the QR code is arranged in a portion of the catheter that remains outside the patient's body.

9. The medical device as defined in claim 8, further characterized in that the QR code is printed on a catheter bifurcation.

10. A medical device for inserting at least partially into a patient; The medical device comprises: a body; Y a distinctive fast response code (QR) mark that is included in the body, the QR code is optically scannable for the purpose of allowing access to information related to at least one characteristic, property, and / or quality of the device doctor.

11. A medical device to be inserted at least partially in a patient; The medical device comprises: a body of the device; Y at least one distinguishing mark of ethanol that is included in the body of the device, at least one distinctive ethanol mark detectable by an observer to indicate a compatibility of the medical device with ethanol or another alcohol-based substance.

12. The medical device as defined in claim 1, further characterized in that at least one distinctive ethanol label is visually perceptible by the observer.

13. The medical device as defined in claim 1, further characterized in that the medical device includes a catheter defining at least one lumen, and further characterized in that the compatibility of the catheter indicates that the ethanol can be disposed within at least one lumen of the catheter without compromising catheter functionality.

14. The medical device as defined in claim 13, further characterized in that at least one distinctive ethanol label includes a dye that is included in a bifurcation.

15. The medical device as defined in claim 14, further characterized in that the dye is substantially yellow, and further characterized in that the dye is additionally included in at least one additional component of the catheter.

16. The medical device as defined in claim 1 1, further characterized in that at least one distinguishing mark includes at least one of an alphanumeric and one conical mark.

17. The medical device as defined in claim 16, further characterized in that the conical mark includes a padlock image.

18. The medical device as defined in claim 16, further characterized in that at least one distinguishing mark includes an abbreviated indication for the word "ethanol".

19. The medical device as defined in claim 11, further characterized in that the medical device includes a catheter, and further characterized in that at least one distinguishing mark includes a discrete indicator piece that slidably attaches to a portion of the catheter.

20. The medical device as defined in claim 19, further characterized in that the indicator piece is slidably attached to a catheter extension leg.

21. The medical device as defined in claim 20, further characterized in that the indicator piece is one of a cylindrical shape and a padlock shape.

22. The medical device as defined in claim 1, further characterized in that the medical device includes a catheter, and further characterized in that at least one distinguishing mark is disposed in a Luer connector of the catheter.

23. The medical device as defined in claim 22, further characterized in that at least one distinguishing mark indicates a percentage concentration of ethanol to which the medical device can be exposed acceptably.

24. The medical device as defined in claim 11, further characterized in that at least one distinctive ethanol label is included in a tube clamp of an extension tube of the medical device.

25. A method for identifying a medical device for compatibility with an alcohol-based substance, the medical device is configured to be inserted, at least partially, into a body of a patient; The method comprising: providing a medical device, the medical device includes at least one distinguishing mark perceptible by an observer to indicate the compatibility of the medical device with an alcohol-based substance; and observing the at least one distinguishing mark to identify the compatibility of the medical device with the alcohol-based substance.

26. The method for identifying as defined in claim 25, further characterized in that the medical device is a catheter, further characterized in that the alcohol-based substance is liquid ethanol, and further characterized in that the compatibility of the catheter includes the ability to block catheter fluid with ethanol.

27. The method for identifying as defined in claim 26, further comprising: insert the catheter in a patient; Y block the catheter fluid according to the observation of the at least one distinguishing mark.

28. A catheter to access an internal portion of a patient; The catheter comprises: a catheter tube defining at least one lumen; Y at least one distinguishing mark of ethanol that is included with the catheter, at least the distinguishing mark of ethanol discernible by an observer to indicate a compatibility of the medical device with ethanol.

29. The catheter as defined in claim 28, further characterized in that the catheter further includes at least one extension leg that is operatively attached to the catheter tube by a colored bifurcation, the bifurcation is colored substantially yellow to serve as at least one a distinctive brand of ethanol.

30. The catheter as defined in claim 29, further characterized in that each extension leg further includes a tube clamp, at least one of the tube clamps that is colored and that additionally includes an alphanumeric mark to serve, additionally, as at least one distinctive brand of ethanol.

31. The catheter as defined in claim 30, further characterized in that the alphanumeric marking includes the letters "ETOH" to indicate that the catheter can be blocked to the fluid with ethanol.