Patent Application
20250228590
The present disclosure relates generally to skin marking devices. More particularly, the present disclosure relates to a device which may use a frame to identify a location for needle placement based on ultrasound, and a marking device which fits within the frame to mark the skin for subsequent needle placement.
Placement of spinal, epidural, or other needles, in the epidural or intrathecal space can sometimes be challenging due to bony structures obstructing the path of the needle; finding the correct insertion site that will allow a direct, unobstructed path for the needle can sometimes be difficult.
In the prior art, technicians sometimes use their fingers to feel the spacing between bones. This can be difficult and unreliable in many cases due to surrounding muscle, fat, and inherent imprecision of doing things by “feel.” Other practices include using an ultrasound probe, however, in many instances, the ultrasound probe must be removed from the skin after identifying an adequate space for placement, and then needle placement occurs after removal of the ultrasound probe. US imaging of the spine allows for identification of gaps within the bony spine, but the technician must then mark the area with a marker, pen, or the like, and then remove the probe. The optimal area is inherently at the center point of the ultrasound probe which cannot be directly accessed without removing the probe. Ultrasound jelly makes marking difficult, because one cannot mark well through it, and marks can be erased when gel is wiped off the skin; more importantly, the ultrasound probe must be removed from the skin, to access the point on the skin that corresponds to the center point of the probe when the appropriate image for a space for needle insertion is seen on screen, and the technician can only estimate the spot where the center of the probe was before it was removed.
Therefore, what is needed is a system which can mark a location for needle insertion reliably after the location is identified by an ultrasound or other imaging device.
The subject matter of this application may involve, in some cases, interrelated products, alternative solutions to a particular problem, and/or a plurality of different uses of a single system or article.
In one aspect, a skin-marking assembly is provided. The skin marking assembly has an outer frame sized to fit closely around an outer perimeter of an ultrasound probe. The assembly further having a marking tool which has top, bottom, left and right edges. These top, bottom, left edge, and right edge are each sized to slideably fit within an inner perimeter of the outer frame. Though in other similar aspects the marking tool may fit to any part of the frame without straying from the scope of this disclosure. The marking tool may further have a protrusion on a front side. The protrusion is sized and configured to form an indent in the skin of a patient when pushed into the skin, so as to mark the skin.
In another aspect, the skin marking assembly has an outer frame sized to fit closely around an outer perimeter of an ultrasound probe. The assembly, further having a marking tool which has top, bottom, left and right edges. These top, bottom, left edge, and right edge are each sized to slideably fit within an inner perimeter of the outer frame. Though in other similar aspects the marking tool may fit to any part of the frame without straying from the scope of this disclosure. The marking tool may further have a protrusion on a front side. This protrusion defines an open shape such that a central opening is defined at a front of the protrusion.
In yet another aspect, a method of marking an area of a patient for placement of an epidural or the like is provided. The method begins with placing or otherwise connecting a frame of a skin-marking assembly on an ultrasound probe. The ultrasound probe may then be used with an ultrasound device to identify a desired location for needle placement, such as a spacing between vertebrae of a patient. Once identified, the frame can be held in place in the position identified and the ultrasound probe can be removed from the frame and away from the patient. A marking tool may then be placed into the frame or connected to the frame. Then, this marking tool can be used for marking the skin of the patient at a location corresponding to the center point of the ultrasound probe.
The detailed description set forth below in connection with the appended drawings is intended as a description of presently preferred embodiments of the invention and does not represent the only forms in which the present disclosure may be constructed and/or utilized. The description sets forth the functions and the sequence of steps for constructing and operating the invention in connection with the illustrated embodiments.
Generally, the present disclosure concerns a skin marking device, also referred to as a skin marking assembly. The present disclosure relates to a device which allows precise marking on a patient as to where to place a needle, cannula, other medical tools, and the like. This system greatly limits the chance of improper needle (and other) placement, creating better and safer patient outcomes.
The system involves, in most embodiments, two parts-a frame which fits around, or partially around, or otherwise engages with a probe of an ultrasound, and a marking tool which engages with the frame and can be used to mark, or guide a marker on the skin of the patient. The mark made using the marking tool can then be used to guide placement of a needle and the like. These components may vary in size, shape, and configuration depending on manufacturer and type of ultrasound probe used.
In many embodiments, the frame is formed of a rectangular, oval, or other similar open shape which has an inside perimeter which fits around the outside perimeter of the ultrasound probe. Other embodiments may use a non-closed shape, like an open frame which connects to only one, two, or three sides of the probe.
In many embodiments, the skin marking tool is sized to precisely engage with the frame. For example, the marking tool may have an outer perimeter, or extending arms, which fit to the frame in only one orientation such that the skin marking can only be made in one place based on frame position. This eliminates the risk of human error in the marking process. For example, the marking tool may have a shape that only allows for it to fit to the frame in one orientation. Preferably, the tool will have at least two points of contact with the frame to ensure that correct orientation of the marking is achieved.
In one embodiment of operation, a method of using the device disclosed herein for marking an area of a patient for placement of an epidural needle (among other operational uses) may first involve placing a frame of a skin-marking assembly over an ultrasound probe. The probe and frame are then placed on the skin of the patient and the probe is manipulated to identify a desirable location for the placement of the epidural, with the frame moving with the ultrasound probe. The location may be identified as, e.g. a spacing between spinous processes of the vertebrae of the patient. The technician may then hold the frame in place while the probe is removed. Next, while holding the frame in place, the marking tool can then be placed into the frame to mark the patient's skin in the desired area as identified by the ultrasound probe. Typically the marking tool is configured to mark the skin at a location where the center of the ultrasound probe was. The marking tool may then be used to mark the skin and/or as a needle guide. Marking may be by pushing a protrusion on the tool into the skin, using a marker or other marking device (which may be either mounted to the marking tool or used in conjunction with the marking tool). In marking embodiments, the entire assembly may be removed because the mark has been made on the patient for subsequent epidural placement. In other embodiments wherein the marking tool is used as a needle guide, the assembly may remain in place, or the frame may be removed.
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It should be noted that while certain examples of the present disclosure have been presented using the present skin marking device with respect to epidural placement, that this device may be used for any number of applications, without straying from the scope of this invention. While several variations of the present disclosure have been illustrated by way of example in preferred or particular embodiments, it is apparent that further embodiments could be developed within the spirit and scope of the present disclosure, or the inventive concept thereof. However, it is to be expressly understood that such modifications and adaptations are within the spirit and scope of the present disclosure, and are inclusive, but not limited to the following appended claims as set forth.
