Ultrasound imaging system

Disclosed herein is an ultrasound imaging system used to place a catheter within a target vessel. The ultrasound imaging system includes an ultrasound probe having an ultrasound array configured to capture one or more ultrasound images of the target vessel and other anatomical targets within a target area. The ultrasound array is in communication with a console configured to automatically detect the target vessel within the one or more ultrasound images and determine a catheter purchase. The ultrasound imaging system further includes one or more sensors in communication with the console, the one or more sensors configured to detect and track one or more magnetic signatures of an elongate medical device within the target area.

BACKGROUND

Determining a catheter purchase (e.g., length of catheter within a target vessel) is important for selecting the correct catheter and correct trajectory to access the target vessel. Current methods of determining the catheter purchase rely on fixed points on an ultrasound image determined by a user. It would be beneficial to the clinician and the patient to have an ultrasound imaging system that automatically determines the catheter purchase using automated vessel detection and needle tracking technologies. Disclosed herein is an ultrasound imaging system and method of use that address the foregoing.

SUMMARY

Disclosed herein is an ultrasound imaging system used to place a catheter within a target vessel. The ultrasound imaging system includes: an ultrasound probe having an ultrasound array configured to capture one or more ultrasound images of the target vessel within a target area; a console in communication with the ultrasound probe; and a medical device tracking system in communication with the console, where the medical device tracking system is configured to determine a position and/or orientation of a needle within the target area. The console includes logic configured to automatically detect the target vessel within the one or more ultrasound images and determine a catheter purchase based on the position and/or orientation of the needle.

In some embodiments, the logic is configured to determine the catheter purchase based on a depth of the target vessel from a skin surface in the target area.

In some embodiments, the logic is configured to determine the depth of the target vessel.

In some embodiments, a user supplies the depth of the target vessel to the target vessel.

In some embodiments, the logic is configured to determine the catheter purchase based on an angle of insertion for the needle.

In some embodiments, the medical device tracking system includes one or more sensors coupled with the ultrasound probe, the one or more sensors configured to detect and track one or more magnetic signatures of the needle within the target area, and in some embodiments, the one or more sensors are configured to detect and track the angle of insertion of the needle.

In some embodiments, a user supplies the angle of insertion to the console.

In some embodiments, a display is in communication with the console, the logic is configured to depict the one or more captured ultrasound images and one or more icons relating to the catheter purchase on the display.

Also disclosed herein is a method of determining a catheter purchase including capturing one or more ultrasound images of a target area, the one or more ultrasound images having one or more target vessels and other anatomical targets, determining a depth of each of the one or more target vessels, determining an insertion site within the target area, determining an angle of insertion of an elongate medical device from the insertion site to access each of the one or more target vessels, and calculating the catheter purchase.

In some embodiments, capturing one or more ultrasound images of the target area includes an ultrasound probe having an ultrasound array in communication with a console capturing the one or more ultrasound images of the target area.

In some embodiments, determining a depth of each of the one or more target vessels includes logic of the console automatically determining a depth of each of the one or more target vessels from a skin surface within the target area.

In some embodiments, determining an insertion site within the target area includes a user or the logic determining a location of the insertion site within the target area.

In some embodiments, determining an angle of insertion of an elongate medical device from the insertion site to access each of the one or more target vessels includes the logic determining the angle of insertion of the elongate medical device by using one or more sensors coupled to the ultrasound probe, the one or more sensors configured to detect the location and orientation of the elongate medical device within the target area.

In some embodiments, the logic determining the angle of insertion of the elongate medical device by using one or more sensors includes the one or more sensors configured to detect one or more magnetic signatures of the elongate medical device.

In some embodiments, determining an angle of insertion of an elongate medical device from the insertion site to access each of the one or more target vessels includes the logic determining an optimal trajectory of the elongate medical device from the insertion site to each of the one or more target vessels, along the angle of insertion.

In some embodiments, determining an angle of insertion of the elongate medical device includes a user determining the angle of insertion of the elongate medical device.

In some embodiments, calculating the catheter purchase includes the logic calculating the catheter purchase based on one or more of the depth of the target vessel, the angle of insertion of the elongate medical device, the location of the insertion site, or the optimal trajectory of the elongate medical device needed to access the target vessel.

In some embodiments, calculating the catheter purchase includes identifying one or more catheters having a catheter purchase length necessary to access the one or more target vessels.

In some embodiments, identifying one or more catheters includes the logic identifying the one or more catheters having the catheter purchase length necessary to access the one or more target vessels.

In some embodiments, calculating the catheter purchase includes calculating the catheter purchase as the elongate medical device is moved through the target area, where moving the elongate medical device through the target area includes changing the angle of insertion.

DESCRIPTION

With respect to “proximal,” a “proximal portion” or a “proximal-end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient. Likewise, a “proximal length” of, for example, the catheter includes a length of the catheter intended to be near the clinician when the catheter is used on the patient. A “proximal end” of, for example, the catheter includes an end of the catheter intended to be near the clinician when the catheter is used on the patient. The proximal portion, the proximal-end portion, or the proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, the proximal-end portion, or the proximal length of the catheter need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal-end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter.

With respect to “distal,” a “distal portion” or a “distal-end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near or in a patient when the catheter is used on the patient. Likewise, a “distal length” of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used on the patient. A “distal end” of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used on the patient. The distal portion, the distal-end portion, or the distal length of the catheter can include the distal end of the catheter; however, the distal portion, the distal-end portion, or the distal length of the catheter need not include the distal end of the catheter. That is, unless context suggests otherwise, the distal portion, the distal-end portion, or the distal length of the catheter is not a terminal portion or terminal length of the catheter.

FIG.1illustrates a perspective view of an ultrasound imaging system100, in accordance with some embodiments. In some embodiments, the ultrasound imaging system100may be used to help place a catheter140within a target vessel152. In some embodiments, the ultrasound imaging system100may be used calculate or otherwise determine a catheter purchase, as further described below. In some embodiments, the ultrasound imaging system100may include an ultrasound probe102having an ultrasound array104configured to capture one or more ultrasound images. In some embodiments, the ultrasound probe102including the ultrasound array104may be in communication with a console110configured to receive the one or more ultrasound images. In some embodiments, the ultrasound probe102may be brought into a target area150to capture one or more ultrasound images of one or more target vessels152and other anatomical targets. In some embodiments, a display106may be in communication with the console110, the display106configured to display the one or more ultrasound images. In some embodiments, the ultrasound imaging system100may be configured to detect a target vessel152, detect an angle of insertion of an elongate medical device180, and determine catheter purchase to place the catheter140within the target vessel152, as will be described in more detail herein. As used herein, an elongate medical device180includes a needle, guidewire, or any other medical device used to access the target vessel152to place the catheter140or any other vascular access device.

The system100may include or otherwise utilize a needle tracking system115configured to detect a position and/or orientation the needle180in three-dimensional space. In some embodiments, the needle tracking system115, or portions thereof, may be included within the console110and/or the ultrasound probe102. In other embodiments, the needle tracking system115may be separate from and coupled with the system100. The needle tracking system115may incorporate various methodologies, such a visual detection (e.g., a camera with or without visual tags), or fiber optic sensing. In some embodiments, the needle tracking system115may incorporate mixed reality or artificial reality modalities such as those described in U.S. published application No. 2022/0031965 which is incorporated herein by reference in its entirety.

In some embodiments, the ultrasound probe102may include one or more sensors170in communication with the console110. In some embodiments, the one or more sensors170may be configured to detect and track in three-dimensional space the needle180. In some embodiments, the one or more sensors170may be configured to track a magnetic signature including a magnetic signature of the needle180. In some embodiments, the one or more sensors170may be configured to detect and track the magnetic signature of additional devices within the target area150including the catheter140, or the like.

FIG.2illustrates a side cross sectional view of the catheter140placed within a target vessel152, in accordance with some embodiments. In some embodiments, the ultrasound imaging system100may be used to place the catheter140within the target vessel152. In properly placing the catheter140within the target vessel152, “catheter purchase” must be determined. In some embodiments, catheter purchase may include (i.e., be the sum of) the length of catheter140within one or more tissues160, the length of catheter140within the target vessel152, and the length of catheter140outside of the tissues160. In some embodiments, catheter purchase may be expressed as percentages of the catheter140that reside within the one or more tissues160, within the target vessel152, and outside of the tissues160. In some embodiments, catheter purchase is an important factor in determining which size and length of catheter140to place within the target vessel152, which vessel will be selected as the target vessel152taking into account vessel depth and vessel size, and appropriate trajectory of the catheter140needed to access the target vessel152.

As illustrated inFIG.2, the target vessel152is located at a first depth156from a skin surface154. In some embodiments, the catheter140may have a first length142outside of the one or more tissues160, a second length144residing within the one or more tissues160along a first angle148, and a third length146residing within the target vessel152. In some embodiments, the catheter140may be placed into the target vessel152at the first angle148relative to the target vessel152. In some embodiments, the first angle148may be an angle of insertion for accessing the target vessel152by the needle180and may be used to determine catheter purchase. In some embodiments, the console110may be configured to determine the depth of each of the vessels152A-152C wherein the depth may include the distance from a skin surface154to the center of a cross section of the vessel, may include the distance from the skin surface154to an outer edge of the vessel, or the like. In some embodiments, the depth may include the distance from an insertion site190to the target vessel152including along the first angle148. In some embodiments, the needle180or the catheter140may be inserted into the target area150at the insertion site190. In some embodiments, the location of the insertion site190within the target area150may be determined by the user. In some embodiments, the catheter purchase may include the sum of the first length142, the second length144, and the third length146while taking into account the first angle148.

In some embodiments, one or more of the first length142, the second length144, the third length146or the first angle148may be determined by the user. By way of example, the first angle148may be a predefined or such as a common angle. In some embodiments, the first angle148may be defined by a needle guide (not shown). Similarly, the first length142and/or the third length146may be predefined the user. Further, in some embodiments, the first depth156may also be known or predefined by the user. As such, one or more of the first length142, first angle148, the first depth156or the third length146may input into the system100and used by the system100to determine/calculate the catheter purchase.

FIG.3Aillustrates a side cross sectional view of an exemplary method of capturing one or more ultrasound images of the target area150having multiple target vessels152A-152C therein. In some embodiments, the ultrasound probe102may be brought into the target area150and the ultrasound array104may be configured to capture one or more ultrasound images of the target area150including one or more target vessels152A-152C and other anatomical targets. In some embodiments, the target area150may include a first vessel152A, a second vessel152B, and a third vessel152C. In some embodiments, the needle180may be brought into the target area150and tracked by the one or more sensors170coupled to the ultrasound probe102. In some embodiments, each of the first vessel152A, the second vessel152B, and the third vessel152C may be evaluated as potential target vessels. In some embodiments, if the first vessel152A is selected as the target vessel, the catheter purchase may be determined for the catheter140to be placed into the first vessel152A. An optimal trajectory of the needle180and the catheter140may be determined using the one or more sensors170tracking the needle180in three-dimensional space within the target area150. The catheter140may have (i) the first length142A outside of the tissues160, (ii) the second length144A inside the tissues160, and (iii) the third length146A within the first vessel152A. In some embodiments, using the same insertion site190, the depth of the target vessel may be configured to impact either the angle of insertion needed to access the target vessel or the catheter purchase required to place the catheter140within the target vessel.

FIG.3Billustrates a front cross sectional view of the exemplary method of capturing one or more ultrasound images of the target area150ofFIG.3A, in accordance with some embodiments. As illustrated inFIG.3B, in some embodiments, the first vessel152A may include a first vessel depth156A, the second vessel152B may include a second vessel depth156B, and the third vessel152C may include a third vessel depth156C. In some embodiments, the second vessel depth156B may be greater than the first vessel depth156A and the third vessel depth156C may be greater than the second vessel depth156B. In some embodiments, the ultrasound array104may communicate the one or more captured ultrasound images to the console110.

FIG.3Cillustrates a perspective view of the display106depicting one of the captured ultrasound images ofFIG.3B. The display106may be configured to depict one of the captured ultrasound images including the first vessel152A, the second vessel152B, and the third vessel152C. In some embodiments, the console110may be configured to determine the depth of each of the vessels152A-152C. In some embodiments, the display106may be configured to display a plurality of icons108. In some embodiments, the plurality of icons108may be related to a selected target vessel, a desired target vessel depth, the actual target vessel depth, a desired angle of insertion of a medical device needed to access the target vessel, an actual angle of insertion of the medical device, a target vessel selector, a catheter purchase calculation, or the like. As illustrated inFIG.3C, the first vessel152A is selected on the display106as the target vessel and various icons108are depicted, demonstrating the target vessel depth (e.g., the first vessel depth156A), the angle of insertion needed to access the first vessel152A, and the catheter purchase calculation.

FIG.3Dillustrates a side cross sectional view of the exemplary method of capturing one or more ultrasound images of the target area150having multiple target vessels152A-152C therein. In some embodiments, if the second vessel152B is selected as the target vessel, the catheter purchase may be determined for the catheter140to be placed into the second vessel152B. The optimal trajectory of the needle180and the catheter140may be determined using the one or more sensors170tracking the needle180in three-dimensional space within the target area150. The catheter140may have the first length142B outside of the tissues160, the second length144B inside the tissues160, and the third length146B within the second vessel152B.

FIG.3Eillustrates a front cross sectional view ofFIG.3D. As illustrated inFIG.3E, in some embodiments, the first vessel152A may include a first vessel depth156A, the second vessel152B may include a second vessel depth156B, and the third vessel152C may include a third vessel depth156C. In some embodiments, the second vessel depth156B may be greater than the first vessel depth156A and the third vessel depth156C may be greater than the second vessel depth156B. In some embodiments, the ultrasound array104may communicate the one or more captured ultrasound images to the console110.

FIG.3Fillustrates a perspective view of the display106depicting the catheter purchase determination, in accordance with some embodiments. Once the console110receives the one or more ultrasound images, the console110may be configured perform catheter purchase calculations and display the catheter purchase results on the display106. In some embodiments, the console110may be configured to take the target vessel depth, the insertion site location, and the angle of insertion needed to access the target vessel152B into account when calculating the catheter purchase. In some embodiments, the console110may be configured to perform catheter purchase calculations for each target vessel152A-152C detected within the target area150or may be configured to perform catheter purchase calculations for only the selected target vessel152B. As illustrated inFIG.3F, the display106may be configured to display one or more of the captured ultrasound images and indicate the target depth for each of the first vessel152A, the second vessel152B, and the third vessel152C. The display106further indicates the angle of insertion148needed to access each of the first vessel152A, the second vessel152B, and the third vessel152C. The display106also indicates the catheter purchase needed to access each of the first vessel152A, the second vessel152B, and the third vessel152C along each indicated angle of insertion. In some embodiments, the console110also may be configured to generate a list of catheter options that successfully fit each of the catheter purchase criteria. Advantageously, using the ultrasound imaging system100to determine catheter purchase allows multiple variables (e.g., automatic determination of target vessels152within the target area150, depth of target vessel152, location of the insertion site190within the target area150, the location or orientation of the needle180within the target area150, the angle of insertion148of the needle180, or the optimal trajectory needed to access the target vessel152) to be used in determining catheter purchase and further allows any of the multiple variables to change while quickly determining catheter purchase.

FIG.4illustrates a block diagram of a console110of the ultrasound imaging system100, in accordance with some embodiments. In some embodiments, the console110may be in communication with each of the display106, one or more sensors170, and the ultrasound array104. In some embodiments, the console110includes one or more processors112, an energy source114, non-transitory computer readable medium (“memory”)116, and a plurality of logic modules. In some embodiments, the plurality of logic modules may include one or more of the following: an ultrasound receiving logic118, a target vessel determination logic120, a target vessel depth determination logic122, an insertion site determination logic124, an insertion angle determination logic126, a needle tracking receiving logic128, a needle tracking determination logic130, a catheter trajectory determination logic132, and a catheter purchase determination logic134. In some embodiments, the ultrasound receiving logic118may be configured to receive the one or more captured ultrasound images from the ultrasound array104. In some embodiments, the target vessel determination logic120may be configured to determine each of the potential target vessels152within the target area150. In some embodiments, the target vessel depth determination logic122may be configured to determine the depth from the skin surface154to each of the target vessels152within the target area150. In some embodiments, the target vessel depth determination logic122may be configured to determine the depth from the insertion site190to each of the target vessels along the angle of insertion148. In some embodiments, the insertion site determination logic124may be configured to determine the insertion site190within the target area150that may be used to access each of the target vessels152. In some embodiments, the insertion site determination logic124may be configured to determine a coordinate location within the target area150as the insertion site190. In some embodiments, the insertion angle determination logic126may be configured to determine the angle of insertion148necessary to access each of the target vessels152. In some embodiments, the user may provide a desired angle of insertion148. In some embodiments, the angle of insertion148may be a predetermined common angle used to access vasculature. In some embodiments, the insertion angle determination logic126may be configured to use the angle of the needle180as the needle180is brought in proximity to the ultrasound probe102to determine the angle of insertion148. In some embodiments, the insertion angle determination logic126may be configured to compare the current angle of insertion148of the needle180with either the desired angle of insertion148as determined by the user or the current angle of insertion148of the needle180along the optimal trajectory of needle180necessary to access the target vessel.

In some embodiments, the needle tracking receiving logic128may be configured to receive data from the one or more sensors170configured to detect and track the magnetic signature of the needle180. In some embodiments, the needle tracking determination logic130may be configured to determine the three-dimensional location and orientation of the needle180within the target area150including the angle of the needle180in relation to each of the target vessels152. In some embodiments, the catheter trajectory determination logic132may be configured to determine the trajectory needed by the catheter140to access the each of the target vessels152. In some embodiments, the catheter trajectory determination logic132may be configured to detect and track the trajectory of the catheter140within the target area150using the ultrasound array104or one or more sensors170when the catheter140includes a magnetic signature thereon. In some embodiments, the catheter purchase determination logic134may be configured to calculate the catheter purchase (length of catheter within tissues/vessel/and outside of body). In some embodiments, the catheter purchase determination logic134may be configured to calculate the catheter purchase using the angle of insertion148, the optimal trajectory, the location of the insertion site190, a target vessel depth, the location of the needle180, or the like to calculate the catheter purchase.

FIG.5illustrates a flow chart of an exemplary method200determining catheter purchase, in accordance with some embodiments. In some embodiments, the method200includes capturing one or more ultrasound images of a target area150having one or more target vessels152(block202). In some embodiments, capturing one or more ultrasound images of the target area150having one or more target vessels152includes using the ultrasound imaging system100including the ultrasound probe102having the ultrasound array104and the one or more sensors170coupled thereto, the ultrasound array104configured to capture the one or more ultrasound images of the target area150while the one or more sensors170are configured to detect and track the magnetic signature of the elongate medical device180. Each of the ultrasound array104and the one or more sensors170in communication with the console110.

In some embodiments, the method200includes determining a depth of each of one or more target vessels152within the target area150(block204). In some embodiments, determining the depth of each of the one or more target vessels152within the target area150includes the console110automatically determining the depth of each of the one or more target vessels152from the skin surface154within the target area150.

In some embodiments, the method200further includes determining an insertion site190within the target area150(block206). In some embodiments, determining the insertion site190within the target area150includes the console110or the user determining the insertion site190within the target area150. In some embodiments, determining the insertion site190within the target area150may include taking into account the depth of each of the one or more target vessels152in determining the insertion site190within the target area150.

In some embodiments, the method200includes determining an angle of insertion148of the elongate medical device180from the insertion site190to access each of the one or more target vessels152(block208). In some embodiments, determining the angle of insertion of the needle180from an insertion site190to access each of the one or more target vessels152includes using the one or more sensors170in communication with the console110to determine a current angle of insertion148of the needle180within the target area150. In some embodiments, determining the angle of insertion of the needle180from the insertion site190to access each of the one or more target vessels152includes using the one or more sensors170coupled to the ultrasound probe102, the one or more sensors configured to detect the location and orientation of the needle180within the target area150, including the one or more magnetic signatures of the needle180.

In some embodiments, determining an angle of insertion148from the insertion site190to access each of the one or more target vessels152includes the console110determining an optimal trajectory of the needle180from the insertion site190needed to access each of the one or more target vessels152. In some embodiments, the console110determining an optimal trajectory of the needle180from the insertion site190needed to access each of the one or more target vessels152includes the console110determining the optimal trajectory of the needle180along the angle of insertion148. In some embodiments, determining an angle of insertion148of the elongate medical device180from the insertion site190to access each of the one or more target vessels152includes the user supplying a pre-determined angle of insertion148to the console110. In some embodiments, the depth of each of the one or more target vessel152may contribute to determining the angle of insertion148of the needle180from the insertion site190to access each of the one or more target vessels152.

In some embodiments, the method200includes calculating catheter purchase needed to access each of the target vessels152(block210). In some embodiments, calculating catheter purchase needed to access each of the target vessels152includes the console110using one or more of: the depth of the target vessel152, the angle of insertion148of the needle180, the location of the insertion site190, or the optimal trajectory of the needle180needed to access the target vessel152to calculate catheter purchase. In some embodiments, calculating catheter purchase needed to access each of the target vessels152includes calculating the total length of the catheter140needed to access each of the target vessels152from the insertion site190. In some embodiments, the total length of the catheter140includes the first length142outside of the tissues160, the second length144within the tissues160, and the third length146within the target vessel152. In some embodiments, calculating catheter purchase needed to access each of the target vessels152includes identifying one or more catheters140having the catheter purchase length necessary to access the one or more target vessels152. In some embodiments, identifying one or more catheters140having the catheter purchase length necessary to access the one or more target vessels152includes the display106in communication with the console110identifying the one or more catheters140having the catheter purchase length necessary to access the one or more target vessels152. In some embodiments, calculating catheter purchase includes calculating catheter purchase as the needle180is actively moved through the target area150, including changing the angle of insertion148.