Venous mapping device, system and method

Abstract

The present disclosure relates to vein mapping devices, systems, and methods. Devices, systems, and methods for printing a vein map onto a patient's skin may include a probe and a printer. The probe may be configured to identify the location of a target vein beneath the patient's skin. The printer may be configured to receive the location and use the location to print a vein map onto the patient's skin to indicate the location. The vein map may include antimicrobial ink printed onto the patient's skin in one or more colors and / or one or more patterns. The vein map may be a two-dimensional or three-dimensional vein map indicating the location of the target vein within the patient, the width of the target vein, and / or the depth of the target vein within the patient.

Description

Background Art

[0001] Catheters are commonly used in a variety of infusion therapies. For example, a catheter can be used to infuse fluids into a patient, such as saline solution, drugs, total parenteral nutrition, etc. A catheter can also be used to draw blood from a patient.

[0002] 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.

[0003] As the name implies, an over-the-needle PIVC can be mounted on a guide needle having a sharp distal tip. The PIVC and the guide needle can be assembled such that the distal tip of the guide needle extends beyond the distal tip of the PIVC, and the bevel of the needle faces away from the patient's skin. The PIVC and the guide needle are typically inserted through the skin at a shallow angle and into a patient's blood vessel, such as the patient's artery, vein, or other vasculature. Once the PIVC is correctly placed within the blood vessel, the guide needle can be withdrawn and the PIVC can be secured within the blood vessel by fixing a catheter adapter (coupled to the PIVC) to the patient's skin with a dressing.

[0004] For adult patients, the insertion success rate of PIVCs is approximately 70%, while for pediatric patients, the success rate is less than 50%. One of the main challenges of successful insertion is correctly identifying and locating a suitable target vein within the patient. For example, for a clinician, non-superficial / deep veins may be difficult to locate within the patient and then difficult to catheterize using existing catheter insertion techniques. Thus, improved devices, systems, and methods for identifying the location of a target vein within a patient would be desirable.

[0005] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or operate only in environments such as the above-described environments. Rather, this background is provided only to illustrate an example technical field in which some of the embodiments described herein may be practiced. Summary of the Invention

[0006] The present disclosure generally relates to devices, systems, and methods for identifying the location of a vein within a patient. In response to the current state of the art, and in particular to problems and needs in the art that have not been fully addressed by currently available devices, systems, and methods for identifying the location of a vein within a patient, various devices, systems, and methods of the present disclosure have been developed to facilitate the insertion of a catheter into a vein.

[0007] In some embodiments, a device for printing a vein map onto a patient's skin may include an ultrasound probe and a print head. The ultrasound probe may be configured to identify the location of a target vein beneath the patient's skin via ultrasound. The print head may be coupled to the ultrasound probe and configured to: (1) receive the location; and (2) use the location to print a vein map onto the patient's skin above the location such that the vein map indicates the location of the target vein within the patient.

[0008] In some embodiments of the device, the vein map may include a two-dimensional vein map that indicates the location of the target vein within the patient beneath the vein map and the width of the target vein.

[0009] In some embodiments of the device, the vein map may include a three-dimensional vein map that indicates the location of the target vein within the patient beneath the vein map, the width of the target vein, and the depth of the target vein within the patient.

[0010] In some embodiments of the device, the three-dimensional vein map may include one or more colors that indicate one or more depths of the target vein within the patient.

[0011] In some embodiments of the device, the three-dimensional vein map may include one or more patterns that indicate one or more depths of the target vein within the patient.

[0012] In some embodiments of the device, the vein map may further indicate a second location of a second target vein beneath the patient's skin.

[0013] In some embodiments, a system for printing a vein map onto a patient's skin may include a probe and a printer. The probe may be configured to identify the location of a target vein beneath the patient's skin. The printer may be configured to receive the location and use the location to print a vein map onto the patient's skin to indicate the location.

[0014] 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 beneath the vein map and the width of the target vein.

[0015] 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 beneath the vein map, the width of the target vein, and the depth of the target vein within the patient.

[0016] 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.

[0017] In some embodiments of the system, the three-dimensional vein map may include a first color indicating a superficial target vein and a second color indicating a deep target vein.

[0018] In some embodiments of the system, the three-dimensional vein map may include one or more patterns indicating one or more depths of the target vein within the patient.

[0019] In some embodiments of the system, the probe may identify the location of the target vein by using imaging techniques, which may include at least one of the following: ultrasound, MRI, NIR, FNIR, X-ray, radiography, fluoroscopy, elastography, photoacoustic imaging, tomography, and nuclear imaging.

[0020] In some embodiments of the system, the probe may include an ultrasound probe that utilizes the Doppler effect to identify the location of the target vein and distinguish the target vein from arteries.

[0021] In some embodiments of the system, the ultrasound probe may be automated to scan the patient'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's skin to indicate the location.

[0022] In some embodiments, a method for printing a vein map onto a patient's skin may include identifying the location of the target vein beneath the patient's skin with a probe; and printing a vein map onto the patient's skin that indicates the location of the target vein within the patient.

[0023] In some embodiments, the method may further include: performing an initial scan of the patient's skin with an ultrasound probe to identify the location of the target vein; performing a subsequent scan of the patient's skin with the ultrasound probe to verify the location of the target vein; and printing a vein map onto the patient's skin with a print head coupled to the ultrasound probe during the subsequent scan, the ultrasound probe being configured to receive the location.

[0024] In some embodiments, the method may further include scanning the patient with a probe to identify the location of the target vein beneath the patient's skin, and printing a vein map onto the patient's skin with a printer configured to receive the location and print the vein map onto the patient's skin.

[0025] In some embodiments of the method, the vein map may include at least one of the following: a two-dimensional vein map that indicates the location of the target vein within the patient beneath the vein map and the width of the target vein; a three-dimensional vein map that indicates the location of the target vein within the patient beneath the vein map, the width of the target vein, and the depth of the target vein within the patient.

[0026] It is to be understood that the foregoing general description and the following detailed description are exemplary and explanatory and do not limit the embodiments of the present disclosure that are claimed. It should be understood that the various embodiments of the present disclosure are not limited to the arrangements and means shown in the drawings. It should also be understood that the embodiments of the present disclosure may be combined, or other embodiments may be utilized, and structural changes (unless so required) may be made without departing from the spirit or scope of the various embodiments of the present disclosure. Accordingly, the following detailed description should not be considered restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] By using the drawings, example embodiments will be described and explained with additional features and details, wherein:

[0028] Figure 1 An example probe according to some embodiments is illustrated, which can be used to identify the location of a target vein under a patient's skin;

[0029] Figure 2 An arm of a patient with an example two - dimensional vein map printed on the patient's skin is illustrated according to some embodiments;

[0030] Figure 3 An arm of a patient with an example partial two - dimensional vein map printed on the patient's skin is illustrated according to some embodiments;

[0031] Figure 4 An arm of a patient with an example three - dimensional vein map printed on the patient's skin is illustrated according to some embodiments;

[0032] Figure 5 An arm of a patient with an example partial three - dimensional vein map printed on the patient's skin is illustrated according to some embodiments; and

[0033] Figure 6 A flowchart of a method for printing a vein map onto a patient's skin according to some embodiments is illustrated.

[0034] It should be understood that the drawings are for the purpose of illustrating the concepts of the present disclosure and may not be drawn to scale. In addition, the drawings illustrate example embodiments and do not represent a limitation on the scope of the present disclosure. DETAILED DESCRIPTION

[0035] The exemplary embodiments of the present disclosure will be best understood by reference to the accompanying drawings, where like parts are always denoted by like numerals. It will be readily understood that the components of the present disclosure, as generally described and illustrated in the drawings herein, may be arranged and designed in a variety of different configurations. Thus, the more detailed description of the embodiments of the apparatus and system as represented in the drawings is not intended to limit the scope of the present disclosure as claimed in this application or any other application claiming priority to this application, but is merely representative of exemplary embodiments of the present disclosure.

[0036] Figure 1 Probe 100 is illustrated, which may be configured to identify the location of a target vein beneath a patient's skin. In some embodiments, probe 100 may include an ultrasound probe configured to: (1) identify the location of the target vein beneath the patient's skin via ultrasound; and (2) use that location to print a vein map onto the patient's skin above that location such that the vein map indicates the location of the target vein within the patient.

[0037] As defined herein, a vein map may include any mark or marker (e.g., line, dot, arrow, pattern, color, etc.) that may be placed on a patient to indicate the location, width, and / or depth of at least one target vein within the patient. In this way, the vein map may assist a clinician during catheter insertion, as will be discussed in more detail below with respect to Figures 2-5 More detailed discussion.

[0038] In some embodiments, the ultrasound probe may generally include a probe body 110, an ultrasound transducer 120, and a print head 130. In some embodiments, as Figure 1 shown, the ultrasound transducer 120 and / or the print head 130 may each be removably coupleable to the probe body 110 and / or to each other. However, in other embodiments, the ultrasound transducer 120 and / or the print head 130 may each be integrated with the probe body 110 and / or with each other. The ultrasound transducer 120 may utilize ultrasound in combination with the Doppler effect to identify the location of the target vein and / or to distinguish the target vein from other veins, arteries, tissue, etc. within the patient. In some embodiments, the ultrasound probe may be used to perform an initial scan of a target insertion site on a patient (e.g., the patient's arm, leg, hand, torso, etc.) in order to identify one or more target veins for catheter insertion. Once the target vein has been identified at the target insertion site, the ultrasound probe may be moved to the target insertion site during a subsequent scan, and the ultrasound transducer 120 may verify the location of the target vein and send it to the print head 130 to print the vein map onto the patient's skin while the ultrasound probe is moved above the target insertion site during the subsequent scan.

[0039] In some embodiments, a system for printing a venous map onto a patient's skin may include a probe 100 and a printer (not shown), and the printer may be separable from the probe 100. The probe 100 may be configured to identify the location of a target vein beneath the patient's skin. The printer may be configured to receive the location and use the location to print a venous map onto the patient's skin to indicate the location of the target vein. The probe 100 may identify the location of the target vein by using any suitable medical imaging technique known in the art, including but not limited to: ultrasound, MRI, NIR, FNIR, X-ray, radiography, fluoroscopy, elastography, photoacoustic imaging, tomography, nuclear imaging, etc.

[0040] In some embodiments, a system for printing a venous map onto a patient's skin may include an automated venous mapping machine (not shown). The automated venous mapping machine may include a container for receiving an anatomical region of the patient (e.g., the patient's arm, leg, hand, torso, etc.). For example, the patient's arm may be received within the container and / or constrained at one or more positions within the automated venous mapping machine. A movable probe may be automated to scan the patient's arm to identify one or more target veins within the patient's arm. Images of the one or more target veins may be stored in the automated venous mapping machine and / or sent to a printer. The printer may be automated to move onto the patient's arm to print a venous map onto the patient's skin, which indicates the location(s) of the one or more target veins.

[0041] In some embodiments, the probe 100 may include an ultrasound probe that utilizes the Doppler effect to identify the location of the target vein and / or distinguish the target vein from other veins, arteries, tissues, etc.

[0042] In some embodiments, the ultrasound probe may be automated to scan the patient's skin and identify the location of the target vein. The printer may also be automated to receive the location from the ultrasound probe and print an automated venous map onto the patient's skin to indicate the location of the target vein.

[0043] Figures 2-5 Illustrated are various example venous maps that have been printed onto a patient's arm. In some embodiments, the venous map may represent the entire scanned area, one or more machine-determined insertion sites, or one or more insertion sites selected by a clinician. Specifically, Figure 2 A two-dimensional venous map 220 printed onto the skin 210 of a patient's arm 200 is shown; Figure 3 A partial two-dimensional venous map 320 printed onto the skin 310 of a patient's arm 300 is shown; Figure 4 A three-dimensional venous map 420 printed onto the skin 410 of a patient's arm 400 is shown; and Figure 5Shows a partial three-dimensional vein map 520 printed on the skin 510 of a patient's arm 500.

[0044] In some embodiments, a comprehensive two-dimensional vein map 220 can be printed on the skin 210 of a patient, as Figure 2 shown. In this way, a clinician can visualize most or all of the patient's veins at the target insertion site and then select a target vein for catheterization.

[0045] In some embodiments, the two-dimensional vein map 220 (or any other vein map described herein) can indicate the position of the target vein within the patient below the vein map and the width of the target vein. For example, the width of the target vein can be directly reflected in the width of the vein printed on the patient's skin. Also, the position of the target vein within the patient can be directly below the vein printed on the patient's skin. However, it will also be understood that any other suitable technique can be utilized to indicate the position and / or width of the target vein. For example, the position of the target vein can be indicated by an arrow or other marking on the patient's skin, which may or may not be directly above the target vein but can be offset from the target vein. This can be desirable if there is a lot of movement of the skin directly above the target vein or if it is not suitable for printing. Similarly, the width of the target vein may not be directly reflected in the width of the vein printed on the patient's skin but can be indicated by other suitable markings printed on the patient's skin.

[0046] In some embodiments, the two-dimensional vein map 220 (or any other vein map described herein) can indicate multiple positions of multiple target veins below the patient's skin.

[0047] In some embodiments, the two-dimensional vein map 220 (or any other vein map described herein) can include antimicrobial ink printed on the patient's skin.

[0048] In some embodiments, the antimicrobial ink of the two-dimensional vein map 220 (or any other vein map described herein) may not be printed directly on the patient's skin. For example, the antimicrobial ink can be printed on other tissues of the patient or on a material covering the patient (e.g., a bandage, fluid, gel, etc. covering the target insertion site of the patient).

[0049] In some embodiments, a partial two-dimensional vein map 320 can be printed on the skin 310 of a patient, as Figure 3 shown. In this way, a clinician can visualize one or more recommended target veins at the target insertion site and select a target vein for catheterization. In Figure 3The first target vein 321, the second target vein 322, and the third target vein 323 are shown in the partial two-dimensional vein map 320. However, it will be understood that any vein map described herein may include any number of target veins.

[0050] In some embodiments, the three-dimensional vein map 420 may be printed onto the skin 410 of a patient, as Figure 4 shown. In this way, 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 catheterization. The Figure 4 first target vein 421 at a first depth and the second target vein 422 at a second depth are shown. 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.

[0051] In some embodiments, one or more colors may be incorporated into the three-dimensional vein maps of the present disclosure to indicate one or more depths of the 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 Figure 4 ).

[0052] In some embodiments, one or more patterns may be incorporated into the three-dimensional vein maps of the present disclosure to indicate one or more depths of the 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 Figure 4 ).

[0053] In some embodiments, a partial three-dimensional vein map 520 may be printed onto the skin 510 of a patient, as Figure 5 shown. In this example, a clinician can visualize the depth of the target vein as it varies at different locations within the patient. Figure 5Illustrates how the depth of a target vein within a patient varies at a first position having a first depth 521, a second position having a second depth 522, a third position having a third depth 523, a fourth position having a fourth depth 524, a fifth position having a fifth depth 525, and a sixth position having a sixth depth 526. As described above, each of these depths can be represented by different colors and / or patterns printed onto the patient's skin. Each of these colors and / or patterns can 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 way, the printed vein map 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 hues / patterns for superficial and deep veins, as Figure 4 shown), or consist of more colors / patterns to provide better depth resolution (e.g., see Figure 5 ). It will also be understood that any feature of any vein map described herein can be mixed and matched with any other vein map described herein. For example, the Figure 4 and 5 different depth patterns / colors can be combined into the Figure 2 and 3 etc. vein maps.

[0054] Figure 6 Illustrates a flowchart of a method 600 for printing a vein map onto a patient's skin according to some embodiments. The method can start at step 610, in which the position of a target vein beneath the patient's skin can be identified using a probe. The probe can identify the position of the target vein by using any suitable medical imaging technique known in the art, including but not limited to ultrasound, MRI, NIR, FNIR, X-ray, radiography, fluoroscopy, elastography, photoacoustic imaging, tomography, nuclear imaging, etc.

[0055] Once the position of the target vein has been identified beneath the patient's skin using the probe, method 600 can proceed to step 620, in which a vein map can be printed onto the patient's skin to indicate the position of the target vein within the patient, and method 600 can end. As discussed above, the vein map can include any markings or labels (e.g., lines, dots, arrows, patterns, colors, etc.) that can be placed on the patient to indicate the position, width, and / or depth of at least one target vein within the patient. In this way, the vein map can assist in guiding the clinician during catheter insertion.

[0056] Alternatively or in addition, in at least some embodiments, method 600 may also proceed to steps 630, 640, and / or 650. In step 630, an initial scan of the patient's skin may be performed with an ultrasound probe to identify the location of the target vein.

[0057] Once an initial scan of the patient's skin has been performed with an ultrasound probe to identify the location of the target vein, method 600 may proceed to steps 640 and / or 650, in which a subsequent scan of the patient's skin may be performed with the ultrasound probe to verify the location of the target vein, and a vein map may be printed onto the patient's skin with a print head coupled to the ultrasound probe during the subsequent scan, the ultrasound probe being configured to receive the location, and method 600 may end.

[0058] Alternatively or in addition, in at least some embodiments, method 600 may also proceed to steps 660 and / or 670. In step 660, a scan of the patient may be performed with a probe to identify the location of the target vein beneath the patient's skin.

[0059] Once a scan of the patient has been performed with a probe to identify the location of the target vein beneath the patient's skin, method 600 may proceed to step 670, in which a vein map may be printed onto the patient's skin with a printer configured to receive the location and print the vein map onto the patient's skin, and method 600 may end.

[0060] Any method disclosed herein includes one or more steps or acts for performing the described method. One or more method steps and / or acts may be omitted from any method disclosed herein. Moreover, any method step and / or act may be interchanged with one another. In other words, unless the correct operation of an embodiment requires a specific order of steps or acts, the order and / or use of specific steps and / or acts may be modified.

[0061] Throughout the specification, references to "an embodiment" or "the embodiment" refer to a particular feature, structure, or characteristic described in connection with that embodiment being included in at least one embodiment. Thus, the recited phrases or variations thereof throughout the specification are not necessarily all referring to the same embodiment. It should be understood that any embodiment of the present disclosure or any (one or more) part of any embodiment of the present disclosure may be combined in any number of different ways.

[0062] Similarly, it should be recognized that in the above description of the embodiments, for the purpose of simplifying the present disclosure, various features are sometimes combined together in a single embodiment, drawing, or description thereof. However, the format of the present disclosure should not be construed as reflecting an intention that any claim requires more features than those expressly recited in that claim. Rather, as reflected in the following claims, the inventive aspect lies in a combination of less than all the features of any single foregoing disclosed embodiment. Thus, the claims following this detailed description expressly incorporate the detailed description therein, where each claim stands on its own as an independent embodiment. The present disclosure includes all permutations of the independent claims and their dependent claims.

[0063] The recitation of the term "first" with respect to a feature or element in a claim does not necessarily imply the existence of a second or additional such feature or element. An element recited in a means-plus-function format is intended to be construed in accordance with 35 U.S.C. § 112, paragraph 6. It will be clear to those skilled in the art that the details of the above-described embodiments can be changed without departing from the basic principles set forth herein.

[0064] Standard medical orientations, reference planes, and descriptive terms 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 the central axis of the body. Dorsal axial means away from the central axis of the body. Ipsilateral means on the same side of the body. Contralateral means on the opposite side of the body. The sagittal plane divides the body into left and right portions. The mid-sagittal plane divides the body into left and right halves that are symmetric about the midline. The coronal plane divides the body into anterior and posterior portions. The transverse plane divides the body into superior and inferior portions. These descriptive terms can be applied to a living or non-living body.

[0065] 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 interactions. Even if two components do not directly contact each other, they can be functionally coupled to each other. The term "adjacent" refers to items that are in direct physical contact with each other, but these items do not necessarily have to be attached together. The phrase "in fluid communication" refers to two features that are connected such that fluid within one feature can enter the other feature.

[0066] As defined herein, "substantially equal to" means "equal to" each other or within a relative variance of approximately + or - 10%.

[0067] The term "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. Although aspects of the embodiments are presented in the drawings, the drawings are not necessarily drawn to scale unless specifically noted.

[0068] While specific embodiments and applications of the present disclosure have been illustrated and described, it should be understood that the scope of the appended claims is not limited to the exact configurations and components disclosed herein. It will be apparent to those skilled in the art that various modifications, changes, and variations can be made to the arrangement, operation, and details of the devices and systems disclosed herein.

[0069] All of the examples and conditional language recited herein are intended for pedagogical purposes to aid the reader in understanding the invention and the concepts contributed by the inventor to further the art, and are to be construed as not being limited to such specifically recited examples and conditions. While the embodiments of the present disclosure have been described in detail, it should be understood that various changes, substitutions, and alterations can be made hereto without departing from the spirit and scope of the present disclosure.

Claims

1. An apparatus for printing a venous map onto a patient's skin, comprising: Probe body, an ultrasonic transducer configured to identify, via ultrasound, a location of a target vein beneath the skin of a patient; and a print head coupled to the ultrasonic transducer and configured to: receive the location; and use the location to print a vein map onto the skin of the patient above the location such that the vein map indicates the location of the target vein within the patient, wherein the ultrasonic transducer and the print head are removably coupled to the probe body and the print head is closely adjacent and distal to the ultrasonic transducer.

2. The apparatus according to claim 1, wherein the venous map comprises a two-dimensional venous map indicating: the position of the target vein within the patient below the venous map; and the width of the target vein.

3. The apparatus according to claim 1, wherein the venous map comprises a three-dimensional venous map indicating: the position of the target vein within the patient below the venous map; the width of the target vein; and the depth of the target vein within the patient.

4. The apparatus according to claim 3, wherein the three-dimensional venous map comprises one or more colors that indicate one or more depths of the target vein within the patient.

5. The apparatus according to claim 3, wherein the three-dimensional venous map comprises one or more patterns that indicate one or more depths of the target vein within the patient.

6. The apparatus according to claim 1, wherein the venous map comprises antimicrobial ink printed onto the patient's skin.

7. The apparatus according to claim 1, wherein the venous map further indicates a second position of a second target vein below the patient's skin.

Images