Abstract:
Apparatus for identifying a patient, said apparatus comprising: a medical device for implantation into the patient; an optical identifier affixed to the device; wherein at least a portion of the optical identifier is radiopaque, whereby to generate a scannable X-ray image of the optical identifier when the medical device is imaged using X-ray.

Description:
REFERENCE TO PENDING PRIOR PATENT APPLICATIONS 
       [0001]    This patent application claims benefit of: 
         [0002]    (i) pending prior U.S. Provisional Patent Application Ser. No. 62/347,242, filed Jun. 8, 2016 by Adam Ross for INTEGRATION OF PATIENT SPECIFIC RADIOPAQUE SCANNABLE CODE WITHIN CARDIAC IMPLANTABLE ELECTRONIC DEVICES (CIEDS) (Attorney&#39;s Docket No. ROSS-1 PROV); and 
         [0003]    (ii) pending prior U.S. Provisional Patent Application Ser. No. 62/393,981, filed Sep. 13, 2016 by Adam Ross for INTEGRATION OF PATIENT SPECIFIC RADIOPAQUE SCANNABLE CODE WITHIN CARDIAC IMPLANTABLE ELECTRONIC DEVICES (CIEDS) (Attorney&#39;s Docket No. ROSS-2 PROV). 
         [0004]    The two (2) above-identified patent applications are hereby incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0005]    This invention relates to implantable medical devices in general, and more particularly to novel optical identifiers applied to implantable medical devices which may be visualized during scanning and used to identify a medical device and/or a patient and/or to access a medical record. 
       BACKGROUND OF THE INVENTION 
       [0006]    Implantable medical devices are often marked with alphanumeric identifiers (e.g., lot numbers, serial numbers, etc.). Such identifiers are commonly used to identify and/or track a medical device (e.g., during manufacture, shipping, use, etc.), and are typically noted in a patient&#39;s medical record, so that in the event of a medical device malfunction, recall, revision surgery, etc., there is a record of the particular implantable medical device which has been implanted into the patient. Inasmuch as the implantable medical device is typically implanted into the patient&#39;s body (and is, therefore, generally inaccessible and not directly viewable after being implanted), a healthcare provider typically requires either access to the patient&#39;s medical record, or direct visual access to the implanted medical device (e.g., via an incision) in order to know the identifier on a particular implanted medical device. 
         [0007]    Alternatively, and/or additionally, an alphanumeric identifier on an implantable medical device may be replaced by (or supplemented by) a radio frequency identification (RFID) “tag”. By way of example but not limitation, more than 400,000 cardiac implantable electronic devices (CIEDs) are implanted into patients every year in the United States. When a patient with one of these devices presents to their cardiologist (or to an emergency department), any cardiac implantable electronic devices (CIEDs) having an RFID chip may then be identified and analyzed via the RFID chip which is embedded within them (and which can communicate with a reader device external to the patient&#39;s body). 
         [0008]    One limitation associated with the current RFID technology is the requirement of a reader device (commonly referred to as a “programmer”), which is typically placed on the patient&#39;s skin over the cardiac implantable electronic device (CIED) and which communicates with the RFID “tag” presented by the cardiac implantable electronic device. The programmer can provide information about the cardiac implantable electronic device itself (i.e., information received from the RFID tag associated with the cardiac implantable electronic device), but the data provided by the RFID tag is limited in nature and does not provide specific information about the patient which can be critical to patient care. Put another way, where an RFID tag is provided to identify the implant, it typically requires a specialized electronic reader (i.e., a “programmer”) to read the RFID tag, and event then the RFID tag does not provide patient-specific information (e.g., the patient&#39;s medical record). In addition, a particular programmer may be device-specific, so it may be necessary to keep multiple programmers on hand. 
         [0009]    If medical records are lost, or if the patient is not able to provide identifying information (e.g., if the patient is unconscious or non-responsive after an accident or other medical event), it would be desirable for a healthcare provider to be able to identify an implanted medical device, and/or the patient, and/or patient-specific information, from identifying information provided on the implanted medical device (but not readily viewable since the implanted medical device is disposed within the patient&#39;s body), without the need for direct visual access to the implanted medical device. In addition, it would be desirable to be able to read the information on an implanted medical device without the need for implant/device-specific electronic “programmers”. 
         [0010]    Thus there is a need for a new and improved optical identifier that can be used to identify an implant and/or the patient and/or patient-specific information without requiring direct visual access to the implant and without requiring specialized programmers or device-specific equipment. 
       SUMMARY OF THE INVENTION 
       [0011]    These and other objects of the present invention are addressed by the provision and use of a novel optical identifier which can be visualized using common X-ray equipment so as to generate a scannable X-ray image which can then be scanned using a common hand-held device (e.g., a smartphone, PDA, etc.), whereby to provide implant-specific and/or patient-specific information to a healthcare provider. 
         [0012]    In one preferred form of the invention, there is provided apparatus for identifying a patient, said apparatus comprising: 
         [0013]    a medical device for implantation into the patient; 
         [0014]    an optical identifier affixed to said device; 
         [0015]    wherein at least a portion of said optical identifier is radiopaque, whereby to generate a scannable X-ray image of said optical identifier when said medical device is imaged using X-ray. 
         [0016]    In another preferred form of the invention, there is provided a method for identifying a patient using an implanted medical device, said method comprising: 
         [0017]    providing an implanted medical device comprising: a medical device for implantation into the patient; 
         [0018]    an optical identifier affixed to said device; 
         [0019]    wherein at least a portion of said optical identifier is radiopaque, whereby to generate a scannable X-ray image of said optical identifier when said medical device is imaged using X-ray; 
         [0020]    using an X-ray source to scan said implanted medical device, whereby to generate a scannable X-ray image of said optical identifier; and 
         [0021]    using a scanner to scan said scannable X-ray image, whereby to scan said optical identifier; 
         [0022]    wherein scanning said optical identifier produces information which can link said radiopaque optical identifier to a database, and further wherein the patient can be identified by looking up said information in said database. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0023]    These and other objects and features of the present invention will be more fully disclosed or rendered obvious by the following detailed description of the preferred embodiments of the invention, which is to be considered together with the accompanying drawings wherein like numbers refer to like parts, and further wherein: 
           [0024]      FIG. 1  is a schematic view showing a novel optical identifier formed in accordance with the present invention being applied to an implantable medical device which is implanted into a patient; 
           [0025]      FIG. 2  is a schematic view showing how the novel optical identifier of  FIG. 1  can be scanned so as to generate an X-ray image; and 
           [0026]      FIG. 3  is a schematic view showing how a handheld scanner may be used to scan the X-ray image of  FIG. 2  so as to obtain implant-specific and/or patient-specific information. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0027]    The present invention comprises the provision and use of a novel optical identifier which can be visualized using common X-ray equipment so as to generate a scannable X-ray image that can be scanned using a common hand-held device (e.g., a smartphone, PDA, etc.), whereby to provide implant-specific and/or patient-specific information to a healthcare provider. 
         [0028]    Looking first at  FIG. 1 , there is shown a novel optical identifier  5  which may be applied to an implantable medical device. Optical identifier  5  preferably comprises an optically-scannable “code” comprising regions of radiopaque material  10  (e.g., the “uncolored” regions of a QR code) and regions of radio-transmissive material  15  (e.g., the “black” regions of a QR code) as the QR code appears on an X-ray image, as will hereinafter be discussed in further detail. In one preferred form of the invention, radiopaque material  10  comprises a 3D printed metal such as gold or tantalum. 
         [0029]    For purposes of clarity, optical identifier  5  will hereinafter sometimes be referred to as a Quick Reference code, or “QR code”, however, it should be appreciated that substantially any optically-scannable identifier may be used with the present invention, as will be apparent to those skilled in the art in view of the present disclosure. By way of example but not limitation, optical identifier  5  may comprise linear bar codes, Data Matrix codes, Quickmark codes, Beetagg codes, Microsoft Tag codes, Trillcode codes, Aztec codes, Shotcode codes, Portable Data Format (PDF) codes, etc. 
         [0030]    Optical identifier  5  is preferably affixed onto (or printed onto, or stamped onto, or formed onto, etc.) an element  20  of an implantable medical device  25 . Element  20  of implantable medical device  25  preferably comprises a portion of implantable medical device  25  having a substantially uniform opacity when imaged using X-rays, as will hereinafter be discussed in further detail. To this end, element  20  preferably comprises a single material, having a uniform thickness at the point where optical identifier  5  is affixed to element  20 . In one preferred form of the invention, element  20  of implantable medical device  25  comprises the battery of a cardiac implantable electronic devices (CIED). Affixing optical identifier  5  to a battery is desirable since the battery typically comprises a material having a substantially constant density, and thereby provides a substantially constant background for visualizing optical identifier  5  on an X-ray scan, as will hereinafter be discussed in further detail. In this form of the invention, optical identifier  5  is preferably printed onto a sticker (or other adhesive) which is then affixed to the battery of the implantable medical device (i.e., to element  20  of implantable medical device  25 ). It will also be appreciated that it may be advantageous to affix optical identifier  5  to the battery of an implantable medical device in order to allow an optical identifier  5  to be added to an implantable medical device which has previously lacked an optical identifier  5  (i.e., so that the optical identifier is provided to the implanted medical device when the battery is replaced). 
         [0031]    Alternatively, if desired, optical identifier  5  may be affixed to a tag which extends away from implantable medical device  25  (e.g., in the manner of a “flag”). 
         [0032]    Implantable medical device  25  is implanted into a patient  30  such that optical identifier  5  lies beneath the skin of the patient (i.e., such that optical identifier  5  is not viewable to the naked eye). 
         [0033]    Looking next at  FIG. 2 , if a healthcare provider desires to visualize optical identifier  5  after implantable medical device  25  has been implanted into patient  30 , an X-ray source  35  may be used to pass X-ray beams through patient  30  such that the X-ray beams are detected by a detector  40 , whereby to generate an X-ray image  45 . It will be appreciated that inasmuch as radiopaque material  10  blocks (or attenuates) the passage of X-rays through the regions of optical identifier  5  comprising radiopaque material  10 , the portions of optical identifier  5  comprising radiopaque material  10  appear comparatively lighter (e.g., “uncolored”) on X-ray image  45  than the portions of optical identifier  5  comprising radio-transmissive material  15  (which allows X-rays to pass through with less attenuation and therefore appears darker, e.g., “black” on X-ray image  45 ). As a result, optical identifier  5  can be easily readable on X-ray image  45  for scanning by a handheld scanner, as will hereinafter be discussed. 
         [0034]    After generating X-ray image  45 , and looking now at  FIG. 3 , a healthcare provider can use a common handheld scanner  50  (e.g., a smartphone, a PDA, a barcode/QR code scanner, etc.) to scan the image of optical identifier  5  appearing on X-ray image  45 . Alternatively, the optical identifier  5  can be digitally scanned (i.e., automatically, using a computer program). 
         [0035]    Optical identifier  5  may be configured to contain information about implantable medical device  25  (e.g., a serial number, lot number, operating information, etc.) and/or optical identifier  5  may be configured to contain patient-specific information and/or link directly to a patient&#39;s medical record. 
         [0036]    By way of example but not limitation, optical identifier  5  may comprise a QR code which incorporates a universal resource locator (URL) which links to a secured website (e.g., which automatically re-directs handheld scanner  50  to an implant-specific and/or patient-specific URL that contains information about the implantable medical device  25  and/or the patient. 
         [0037]    By way of example but not limitation, optical identifier  5  could link to an internal or external site (e.g., a website)  55  which could, in turn, link to one or more databases (e.g., a database  60  containing implant-specific data, a database  65  containing patient-specific data, a database  70  containing a patient medical record, etc). If desired, a patient may be able to control access to information retained on external (or internal) site  55 , e.g., via a password-protected URL. 
         [0038]    In this way, optical identifier  5  can allow a healthcare provider to access implant information and/or critical patient information (e.g., allergies, medications, next of kin, baseline EKG, etc.) using only a common, widely-available X-ray equipment and a common, widely-available handheld scanner, thereby avoiding the need for direct physical access to implantable medical device  25  or device-specific electronic equipment (e.g., “programmers”). 
         [0039]    Optical identifier  5  may also be used to provide information which could be used to directly control the implantable medical device  25 . By way of example but not limitation, optical identifier  5  could take the place of a traditional RFID within the implantable medical device  25 , or optical identifier  5  could work in conjunction with the RFID as part of a two-factor authentication process. Alternatively and/or additionally, optical identifier  5  could serve as a backup to the RFID included with implantable medical device  25 , should the RFID element of the implantable medical device became nonfunctional. In addition, if desired, an identical optical identifier  5  could be printed on a physical “implant card” that is carried by the patient, so as provide a backup in a situation where optical identifier  5  becomes unreadable on an X-ray image due to interference/damage. 
         [0040]    It will be appreciated that the provision and use of optical identifier  5  on an implantable medical device provides numerous benefits in addition to those discussed above. 
         [0041]    By way of example but not limitation, optical identifier  5  may be configured to link to a patient medical record, whereby to provide information to a healthcare provider even when the patient is unconscious or non-responsive. For example, if a patient has a cardiac implantable electronic device (CIED) such as a pacemaker, and the patient collapses outside their home (e.g., while running, while at the gym, etc.), the patient may be unable to provide any identifying information to emergency personnel. However, when a routine chest X-ray is thereafter performed (e.g., in the emergency department, as is typical for such a medical event), optical identifier  5  could be viewed on the X-ray image generated, and thereafter scanned by a healthcare provider, so as to provide the healthcare provider with information about the cardiac implantable electronic device (CIED) or about the patient (e.g., via a URL that links to a patient medical record), thereby facilitating treatment of the patient. 
         [0042]    In addition, as discussed above, optical identifier  5  preferably comprises an optically-scannable pattern comprising a radiopaque material  10  and a radio-transmissive material  15 . If desired, radiopaque material  10  may comprise an iridium-based ink or film which may be printed on implantable medical device  25 . Iridium is a rare earth metal with many unique properties (e.g., it is extremely dense and has a high periodic number). These properties make it one of the most radiopaque elements and therefore an ideal candidate for use with medical imaging (e.g., X-ray imaging). 
         [0043]    In addition to placing optical identifier  5  on implantable medical device  25 , a second (e.g., identical or different) optical identifier (e.g., a iridium-based optical identifier) could be affixed to the outside of the patient&#39;s body, such that both optical identifier  5  and the second optical identifier can be visualized on the same X-ray image. By way of example but not limitation, the second optical identifier could comprise a patch or sticker worn by all patients who will be receiving multiple chest x-rays (e.g., patients on ventilators). The utility of this application would be as a post-test safeguard against inadvertent switching of X-ray films with another patient. The second optical identifier may be placed on the patient&#39;s back, outside the area of the ribcage so as not to interfere with the critical part of the film. 
       Modifications of the Preferred Embodiments 
       [0044]    It should be understood that many additional changes in the details, materials, steps and arrangements of parts, which have been herein described and illustrated in order to explain the nature of the present invention, may be made by those skilled in the art while still remaining within the principles and scope of the invention.