Patent Publication Number: US-2021186649-A1

Title: Vein mapping devices, systems, and methods

Description:
RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Application No. 62/949,893, filed Dec. 18, 2019, and entitled VEIN MAPPING DEVICES, SYSTEMS, AND METHODS, which is incorporated herein in its entirety. 
    
    
     BACKGROUND 
     Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used for infusing fluids into a patient such as saline solution, medication, total parenteral nutrition, etc. Catheters may also be used for withdrawing blood from the patient. 
     A common type of catheter is an over-the-needle peripheral intravenous catheter (“PIVC”). Other common types of catheters include, but are not limited to, peripherally inserted central catheters (“PICC”), central venous catheters (“CVC”), etc. 
     As its name implies, the over-the-needle PIVC may be mounted over an introducer needle having a sharp distal tip. The PIVC and the introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the PIVC with the bevel of the needle facing away from skin of the patient. The PIVC and the introducer needle are typically inserted at a shallow angle through the skin and into a blood vessel of the patient, such as an artery, a vein, or other vasculature of the patient. Once the PIVC has been properly placed within the blood vessel, the introducer needle may be withdrawn and the PIVC may be secured within the blood vessel by securing a catheter adapter (coupled with the PIVC) to the skin of the patient with dressing. 
     The insertion success rate for a PIVC is about 70% for adult patients and less than 50% for pediatric patients. One of the main challenges to successful insertion is correctly identifying and locating a suitable target vein within the patient. For example, non-superficial/deep veins may be difficult for a clinician to locate within a patient and then target for catheter insertion utilizing existing catheter insertion techniques. Accordingly, improved devices, systems, and methods for identifying a location of a target vein within a patient would be desirable. 
     The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where some implementations described herein may be practiced. 
     SUMMARY 
     The present disclosure generally relates to devices, systems, and methods for identifying a location of a vein in a patient. The various devices, systems, and methods of the present disclosure have been developed in response to the present state of the art, and in particular, in response to the problems and needs in the art that have not yet been fully solved by currently available devices, systems, and methods for identifying a location of a vein within a patient to facilitate insertion of a catheter into the vein. 
     In some embodiments, an apparatus for printing a vein map onto a patient&#39;s skin may include an ultrasonic probe and a print head. The ultrasonic probe may be configured to identify a location of a target vein beneath the patient&#39;s skin via ultrasound. The print head may be coupled to the ultrasonic probe and configured to: (1) receive the location; and (2) using the location, print the vein map onto the patient&#39;s skin above the location such that the vein map indicates the location of the target vein within the patient. 
     In some embodiments of the apparatus, the vein map may include a two-dimensional vein map that indicates the location of the target vein within the patient below the vein map, and a width of the target vein. 
     In some embodiments of the apparatus, the vein map may include a three-dimensional vein map that indicates the location of the target vein within the patient below the vein map, a width of the target vein, and a depth of the target vein within the patient. 
     In some embodiments of the apparatus, the three-dimensional vein map may include one or more colors that indicate one or more depths of the target vein within the patient. 
     In some embodiments of the apparatus, the three-dimensional vein map may include one or more patterns that indicate one or more depths of the target vein within the patient. 
     In some embodiments of the apparatus, the vein map may further indicate a second location for a second target vein beneath the patient&#39;s skin. 
     In some embodiments, a system for printing a vein map onto a patient&#39;s skin may include a probe and a printer. The probe may be configured to identify a location of a target vein beneath the patient&#39;s skin. The printer may be configured to receive the location and, using the location, print the vein map onto the patient&#39;s skin to indicate the location. 
     In some embodiments of the system, the vein map may include a two-dimensional vein map that indicates the location of the target vein within the patient below the vein map, and a width of the target vein. 
     In some embodiments of the system, the vein map may include a three-dimensional vein map that indicates the location of the target vein within the patient below the vein map, a width of the target vein, and a depth of the target vein within the patient. 
     In some embodiments of the system, the three-dimensional vein map may include one or more colors that indicate one or more depths of the target vein within the patient. 
     In some embodiments of the system, the three-dimensional vein map may include a first color that indicates a superficial target vein and a second color that indicates a deep target vein. 
     In some embodiments of the system, the three-dimensional vein map may include one or more patterns that indicate one or more depths of the target vein within the patient. 
     In some embodiments of the system, the probe may identify the location of the target vein through use of an imaging technique that may include at least one of: ultrasound, MRI, NIR, FNIR, X-rays, radiography, fluoroscopy, elastography, photoacoustic imaging, tomography, and nuclear imaging. 
     In some embodiments of the system, the probe may include an ultrasonic probe that utilizes the Doppler effect to identify the location of the target vein and differentiate the target vein from an artery. 
     In some embodiments of the system, the ultrasonic probe may be automated to scan over the patient&#39;s skin and identify the location of the target vein, and the printer may be automated to receive the location and print an automated vein map onto the patient&#39;s skin to indicate the location. 
     In some embodiments, a method for printing a vein map onto a patient&#39;s skin may include identifying a location of a target vein below the patient&#39;s skin with a probe, and printing a vein map onto the patient&#39;s skin that indicates the location of the target vein within the patient. 
     In some embodiments, the method may further include: performing an initial scan of the patient&#39;s skin with an ultrasonic probe to identify the location of the target vein; performing a subsequent scan of the patient&#39;s skin with the ultrasonic probe to verify the location of the target vein; and printing the vein map onto the patient&#39;s skin during the subsequent scan with a print head coupled to the ultrasonic probe that is configured to receive the location. 
     In some embodiments, the method may further include performing a scan of the patient with the probe to identify the location of the target vein below the patient&#39;s skin, and printing the vein map onto the patient&#39;s skin with a printer that is configured to receive the location and print the vein map onto the patient&#39;s skin. 
     In some embodiments of the method, the vein map may include at least one of: a two-dimensional vein map that indicates the location of the target vein within the patient below the vein map and a width of the target vein; and a three-dimensional vein map that indicates the location of the target vein within the patient below the vein map, a width of the target vein, and a depth of the target vein within the patient. 
     It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the embodiments of the present disclosure, as claimed. It should be understood that the various embodiments of the present disclosure are not limited to the arrangements and instrumentality shown in the drawings. It should also be understood that the embodiments of the present disclosure may be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the spirit or scope of the various embodiments of the present disclosure. The following detailed description is, therefore, not to be taken in a limiting sense. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIG. 1  illustrates an example probe that may be utilized to identify a location of a target vein beneath a patient&#39;s skin, according to some embodiments; 
         FIG. 2  illustrates an arm of a patient with an example two-dimensional vein map printed onto the patient&#39;s skin, according to some embodiments; 
         FIG. 3  illustrates an arm of a patient with an example partial two-dimensional vein map printed onto the patient&#39;s skin, according to some embodiments; 
         FIG. 4  illustrates an arm of a patient with an example three-dimensional vein map printed onto the patient&#39;s skin, according to some embodiments; 
         FIG. 5  illustrates an arm of a patient with an example partial three-dimensional vein map printed onto the patient&#39;s skin, according to some embodiments; and 
         FIG. 6  illustrates a flow chart of a method for printing a vein map onto a patient&#39;s skin, according to some embodiments. 
     
    
    
     It is to be understood that the Figures are for purposes of illustrating the concepts of the present disclosure and may not be drawn to scale. Furthermore, the Figures illustrate exemplary embodiments and do not represent limitations to the scope of the present disclosure. 
     DESCRIPTION OF EMBODIMENTS 
     Exemplary embodiments of the present disclosure will be best understood by reference to the Figures, wherein like parts are designated by like numerals throughout. It will be readily understood that the components of the present disclosure, as generally described and illustrated in the Figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the apparatus and systems, as represented in the Figures, is not intended to limit the scope of the present disclosure, as claimed in this or any other application claiming priority to this application, but is merely representative of exemplary embodiments of the present disclosure. 
       FIG. 1  illustrates a probe  100  that may be configured to identify a location of a target vein beneath a patient&#39;s skin. In some embodiments, the probe  100  may include an ultrasonic probe configured to: (1) identify the location of the target vein beneath the patient&#39;s skin via ultrasound; and (2) using the location, print a vein map onto the patient&#39;s skin above the location such that the vein map indicates the location of the target vein within the patient. 
     As defined herein, a vein map may include any marking or indicia (e.g., a line, dot, arrow, pattern, color, etc.) that may be placed on a patient to indicate a location, a width, and/or a depth of at least one target vein within the patient. In this manner, the vein map may help guide a clinician during catheter insertion, as will be discussed below in more detail with respect to  FIGS. 2-5 . 
     In some embodiments, the ultrasonic probe may generally include a probe body  110 , an ultrasonic transducer  120 , and a print head  130 . In some embodiments, the ultrasonic transducer  120  and/or the print head  130  may each be removably couplable to the probe body  110  and/or to each other, as shown in  FIG. 1 . However, in other embodiments, the ultrasonic transducer  120  and/or the print head  130  may each be integrated with the probe body  110  and/or with each other. The ultrasonic transducer  120  may utilize ultrasound in conjunction with the Doppler effect to identify the location of the target vein and/or to differentiate the target vein from other veins, arteries, tissues, etc., within the patient. In some embodiments, the ultrasonic probe may be utilized to perform an initial scan of a target insertion site on the patient (e.g., an arm, a leg, a hand, a torso, etc., of the patient) in order to identify one or more target veins for catheter insertion. Once a target vein has been identified at the target insertion site, the ultrasonic probe may be moved over the target insertion site in a subsequent scan and the ultrasonic transducer  120  may verify and send the location of the target vein to the print head  130  for printing a vein map onto the patient&#39;s skin while the ultrasonic probe is moved over the target insertion during the subsequent scan. 
     In some embodiments, a system for printing a vein map onto a patient&#39;s skin may include the probe  100  and a printer (not shown), which may be separate from the probe  100 . The probe  100  may be configured to identify the location of the target vein beneath the patient&#39;s skin. The printer may be configured to receive the location and, using the location, print a vein map onto the patient&#39;s skin to indicate the location of the target vein. The probe  100  may identify the location of the target vein through the use of any suitable medical imaging technique known in the art including, but not limited to: ultrasound, MRI, NIR, FNIR, X-rays, radiography, fluoroscopy, elastography, photoacoustic imaging, tomography, nuclear imaging, etc. 
     In some embodiments, a system for printing a vein map onto a patient&#39;s skin may include an automated vein mapping machine (not shown). The automated vein mapping machine may include a receptacle to receive an anatomical region of the patient (e.g., an arm, a leg, a hand, a torso, etc., of the patient). For example, an arm of the patient may be received within the receptacle and/or restrained at one or more locations within the automated vein mapping machine. A movable probe may be automated to scan over the patient&#39;s arm to identify one or more target veins within the patient&#39;s arm. An image of the one or more target veins may be stored in the automated vein mapping machine and/or sent to the printer. A printer may be automated to move over the patient&#39;s arm to print out a vein map onto the skin of the patient that indicates the location(s) of the one or more target veins. 
     In some embodiments, the probe  100  may include an ultrasonic probe that utilizes the Doppler effect to identify the location of the target vein and/or to differentiate the target vein from other veins, arteries, tissues, etc. 
     In some embodiments, the ultrasonic probe may be automated to scan over the patient&#39;s skin and identify the location of the target vein. The printer may also be automated to receive the location from the ultrasonic probe and print an automated vein map onto the patient&#39;s skin in order to indicate the location of the target vein. 
       FIGS. 2-5  illustrate various example vein maps that have been printed onto an arm of a patient. In some embodiments, the vein maps can represent an entire scanned area, one or more machine-determined insertion sites, or one or more insertion sites selected by a clinician. Specifically,  FIG. 2  shows a two-dimensional vein map  220  printed onto the skin  210  of the patient&#39;s arm  200 ;  FIG. 3  shows a partial two-dimensional vein map  320  printed onto the skin  310  of the patient&#39;s arm  300 ;  FIG. 4  shows a three-dimensional vein map  420  printed onto the skin  410  of the patient&#39;s arm  400 ; and  FIG. 5  shows a partial three-dimensional vein map  520  printed onto the skin  510  of the patient&#39;s arm  500 . 
     In some embodiments, a two-dimensional vein map  220  that is comprehensive may be printed onto skin  210  of the patient, is shown in  FIG. 2 . In this manner, a clinician can visualize most or all of the patient&#39;s veins at the target insertion site and may then select a target vein for catheter insertion. 
     In some embodiments, the two-dimensional vein map  220  (or any other vein map described herein) may indicate the location of the target vein within the patient below the vein map, as well as a width of the target vein. For example, the width of the target vein may be directly reflected in the width of the printed vein on the patient&#39;s skin. Moreover, the location of the target vein within the patient may lie directly below the printed vein on the patient&#39;s skin. However, it will also be understood that any other suitable technique may be utilized to indicate a location and/or a width of a target vein. For example, a location of a target vein may be indicated by arrows or other indicia on the patient&#39;s skin that may or may lie directly above a target vein, but may be offset from the target vein. This may be desirable if the skin directly above the target vein moves a lot or otherwise is not suitable for printing. Likewise, a width of a target vein may not be directly reflected in a width of a printed vein on the patient&#39;s skin, but may be indicated by other suitable indicia printed onto the patient&#39;s skin. 
     In some embodiments, the two-dimensional vein map  220  (or any other vein map described herein) may indicate a plurality of locations for a plurality of target veins beneath the patient&#39;s skin. 
     In some embodiments, the two-dimensional vein map  220  (or any other vein map described herein) may include an antimicrobial ink printed onto the patient&#39;s skin. 
     In some embodiments, the antimicrobial ink of the two-dimensional vein map  220  (or any other vein map described herein) may not be directly printed onto the patient&#39;s skin. For example, the antimicrobial ink may be printed onto other tissues of the patient, or onto a material that covers the patient (e.g., a bandage, a fluid, a gel, etc., covering the target insertion site of the patient). 
     In some embodiments, a partial two-dimensional vein map  320  may be printed onto the skin  310  of the patient, as shown in  FIG. 3 . In this manner, a clinician can visualize one or more recommended target veins at a target insertion site and select a target vein for catheter insertion. A first target vein  321 , a second target vein  322 , and a third target vein  323  are shown in the partial two-dimensional vein map  320  of  FIG. 3 . However, it will be understood that any of the vein maps described herein may include any number of target veins. 
     In some embodiments, a three-dimensional vein map  420  may be printed onto the skin  410  of the patient, as shown in  FIG. 4 . In this manner, a clinician can visualize one or more target veins at one or more locations and depths within the patient and select a target vein for catheter insertion. A first target vein  421  at a first depth and a second target vein  422  at a second depth are shown in  FIG. 4 . However, it will be understood that any number of target veins at any number of depths may be represented within the vein maps of the present disclosure. 
     In some embodiments, one or more colors may be incorporated into the three-dimensional vein maps of the present disclosure to represent one or more depths of target veins within the patient. For example, in some embodiments a first color may indicate a superficial target vein and a second color may indicate a deep target vein (e.g., see  FIG. 4 ). 
     In some embodiments, one or more patterns may be incorporated into the three-dimensional vein maps of the present disclosure to represent one or more depths of target veins within the patient. For example, in some embodiments a first pattern (e.g., dots, etc.) may indicate a superficial target vein, and a second pattern (e.g., lines, etc.) may indicate a deep target vein (e.g., see  FIG. 4 ). 
     In some embodiments, a partial three-dimensional vein map  520  may be printed onto the skin  510  of the patient, as shown in  FIG. 5 . In this example, a clinician can visualize a target vein as its depth varies within the patient at different locations.  FIG. 5  shows how the depth of the target vein can vary within the patient at a first location having a first depth  521 , a second location having a second depth  522 , a third location having a third depth  523 , a fourth location having a fourth depth  524 , a fifth location having a fifth depth  525 , and a sixth location having a sixth depth  526 . Each of these depths may be represented by a different color and/or pattern printed onto the patient&#39;s skin, as described above. Each of these colors and/or patterns may also correspond to different depth values and/or different depth ranges (e.g., 2-5 mm for the first depth  521 , 5-8 mm for the second depth  522 , etc.). In this manner, the printed vein maps of the present disclosure can be color coded and/or pattern coded to indicate one or more depths for one or more target veins. The color/pattern coding scheme can be simple (e.g., two tones/patterns for superficial and deep veins, as shown in  FIG. 4 ) or consist of more colors/patterns to provide better depth resolution (e.g., see  FIG. 5 ). It will also be understood that any characteristic of any vein map described herein may be mixed and matched with any other vein map that is described herein. For example, the different depth patterns/colors of  FIGS. 4 and 5  may be incorporated into the vein maps of  FIGS. 2 and 3 , etc. 
       FIG. 6  illustrates a flow chart of a method  600  for printing a vein map onto a patient&#39;s skin, according to some embodiments. The method may begin with a step  610  in which a location of a target vein may be identified below the patient&#39;s skin with a probe. The probe may identify the location of the target vein through the use of any suitable medical imaging technique known in the art including, but not limited to ultrasound, MRI, NIR, FNIR, X-rays, radiography, fluoroscopy, elastography, photoacoustic imaging, tomography, nuclear imaging, etc. 
     Once the location of the target vein has been identified below the patient&#39;s skin with the probe, the method  600  may proceed to a step  620  in which a vein map may be printed onto the patient&#39;s skin to indicate the location of the target vein within the patient, and the method  600  may end. As discussed above, the vein map may include any marking or indicia (e.g., a line, dot, arrow, pattern, color, etc.) that may be placed on a patient to indicate a location, a width, and/or a depth of at least one target vein within the patient. In this manner, the vein map may help guide a clinician during catheter insertion. 
     Alternatively, or in addition thereto, the method  600  may proceed to steps  630 ,  640 , and/or  650 , in at least some embodiments. In the step  630 , an initial scan of the patient&#39;s skin may be performed with an ultrasonic probe to identify the location of the target vein. 
     Once the initial scan of the patient&#39;s skin has been performed with the ultrasonic probe to identify the location of the target vein, the method  600  may proceed to steps  640  and/or  650  in which a subsequent scan of the patient&#39;s skin may be performed with the ultrasonic probe to verify the location of the target vein, and the vein map may be printed onto the patient&#39;s skin during the subsequent scan with a print head coupled to the ultrasonic probe that is configured to receive the location, and the method  600  may end. 
     Alternatively, or in addition thereto, the method  600  may proceed to steps  660  and/or  670 , in at least some embodiments. In the step  660 , a scan of the patient may be performed with the probe to identify the location of the target vein below the patient&#39;s skin. 
     Once the scan of the patient has been performed with the probe to identify the location of the target vein below the patient&#39;s skin, the method  600  may proceed to step  670  in which the vein map may be printed onto the patient&#39;s skin with a printer that is configured to receive the location and print the vein map onto the patient&#39;s skin, and the method  600  may end. 
     Any methods disclosed herein include one or more steps or actions for performing the described method. One or more of the method steps and/or actions may be omitted from any of the methods disclosed herein. Moreover, any of the method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified. 
     Reference throughout this specification to “an embodiment” or “the embodiment” means that a particular feature, structure or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the quoted phrases, or variations thereof, as recited throughout this specification are not necessarily all referring to the same embodiment. It is to be understood that any of the embodiments of the present disclosure, or any portion(s) of any of the embodiments of the present disclosure, may be combined together in any number of different ways. 
     Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, Figure, or description thereof for the purpose of streamlining the disclosure. This disclosure format, however, is not to be interpreted as reflecting an intention that any claim requires more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment. Thus, the claims following this Description Of Embodiments are hereby expressly incorporated into this Description Of Embodiments, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims. 
     Recitation in the claims of the term “first” with respect to a feature or element does not necessarily imply the existence of a second or additional such feature or element. Elements recited in means-plus-function format are intended to be construed in accordance with 35 U.S.C. § 112 Para. 6. It will be apparent to those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles set forth herein. 
     Standard medical directions, planes of reference, and descriptive terminology are employed in this specification. For example, anterior means toward the front of the body. Posterior means toward the back of the body. Superior means toward the head. Inferior means toward the feet. Medial means toward the midline of the body. Lateral means away from the midline of the body. Axial means toward a central axis of the body. Abaxial means away from a central axis of the body. Ipsilateral means on the same side of the body. Contralateral means on the opposite side of the body. A sagittal plane divides a body into right and left portions. A midsagittal plane divides the body into bilaterally symmetric right and left halves. A coronal plane divides a body into anterior and posterior portions. A transverse plane divides a body into superior and inferior portions. These descriptive terms may be applied to an animate or inanimate body. 
     The phrases “connected to,” “coupled to,” “engaged with,” and “in communication with” refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be functionally coupled to each other even though they are not in direct contact with each other. The term “abutting” refers to items that are in direct physical contact with each other, although the items may not necessarily be attached together. The phrase “fluid communication” refers to two features that are connected such that a fluid within one feature is able to pass into the other feature. 
     As defined herein, “substantially equal to” means “equal to,” or within about a + or −10% relative variance from one another. 
     The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments. While the various aspects of the embodiments are presented in the Figures, the Figures are not necessarily drawn to scale unless specifically indicated. 
     While specific embodiments and applications of the present disclosure have been illustrated and described, it is to be understood that the scope of the appended claims is not limited to the precise configuration and components disclosed herein. Various modifications, changes, and variations which will be apparent to those skilled in the art may be made in the arrangement, operation, and details of the apparatus and systems disclosed herein. 
     All examples and conditional language recited herein are intended for pedagogical objects to aid the reader in understanding the invention and the concepts contributed by the inventor to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Although embodiments of the present disclosure have been described in detail, it should be understood that the various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the present disclosure.