US-12616456-B2 - System for color-coding medical instrumentation and methods of use

Abstract

A system including a biopsy needle device having a cannula with a distal end configured to sever a tissue sample, and a trocar disposed within the cannula having a notch configured to retain a tissue sample, wherein at least one of the cannula and the trocar is divided into at least two segments including different echogenic coatings, an ultrasound probe, and a processor configured and arranged to collect images from the ultrasound probe and color code the at least two segments based on at least one characteristic relating to different echogenic coatings, surface textures, surface contours and dimensions of the biopsy device.

Inventors

• Steven Poplaw

Assignees

• Clear Biopsy LLC

Dates

Publication Date

20260505

Application Date

20250815

Claims (20)

1. 1 . A percutaneous medical device, comprising: a plurality of portions, each portion including at least one structural or material characteristic configured to have a unique visualization under medical imaging, wherein the at least one structural or material characteristic of the each portion of the percutaneous medical device is different in a manner such that it causes the unique visualization for the each portion of the percutaneous medical device to align with a respective predetermined detection target of an imaging analysis process that includes the unique visualization under medical imaging.
2. 2 . The percutaneous medical device of claim 1 , wherein the unique visualizations are caused by one or more of: a difference in materials included in or coated onto the plurality of portions; different surface disruptions included in surfaces of the plurality of portions; at least one foci positioned at one or more predetermined region of the plurality of portions; or a surface contour having a predetermined association with a particular portion.
3. 3 . The percutaneous medical device of claim 2 , wherein the difference in materials is configured such that each of the plurality of portions has a unique echogenicity or radiopacity.
4. 4 . The percutaneous medical device of claim 2 , wherein the difference in materials is caused by different proportions of microbubbles of a visualization material mixed with a biocompatible material.
5. 5 . The percutaneous medical device of claim 2 , wherein the different surface disruptions include one or more of dimples, grooves, texturing, or reflectors.
6. 6 . The percutaneous medical device of claim 2 , wherein: at least one foci is positioned to identify a distal end of a portion or of the percutaneous medical device; and at least one further foci is positioned to identify a proximal end of a portion or of the percutaneous medical device.
7. 7 . The percutaneous medical device of claim 1 , wherein the medical imaging is ultrasound imaging.
8. 8 . The percutaneous medical device of claim 1 , wherein the percutaneous medical device includes one or more of a biopsy device, a needle, a vacuum-assisted device, a clip or marker, an RFID clip or marker, a vascular access device, a stent, a filter, an angioplasty, a drain, or a catheter.
9. 9 . A medical imaging colorization system, comprising: a percutaneous medical device that includes a plurality of portions, each portion configured to have a unique visualization under medical imaging, wherein the unique visualizations of the plurality of portions are configured to align with predetermined detection targets of an imaging analysis process; and an imaging analysis device that includes: a display; at least one memory storing instructions; and at least one processor operatively connected to the at least one memory and to the display, and configured to execute the instructions to perform the imaging analysis process by: receiving medical imaging of the percutaneous medical device within a body of a patient; identifying two or more of the plurality of portions by mapping the unique visualizations to portion labels associated with the predetermined detection targets; applying different coloring to each of the one two or more portions in the medical imaging based on the identifying; and causing the display to output the medical imaging that includes the different coloring.
10. 10 . The medical imaging colorization system of claim 9 , wherein the identifying includes applying a machine-learning model to the medical imaging, the machine-learning model having been trained based on medical imaging of training medical devices with portions having different visualizations and training labels for the portions.
11. 11 . The medical imaging colorization system of claim 9 , wherein the unique visualization is caused by one or more of: a difference in materials included in or coated onto the plurality of portions; different surface disruptions included in surfaces of the plurality of portions; at least one foci positioned at one or more predetermined region of the plurality of portions; or a surface contour having a predetermined association with a particular portion.
12. 12 . The medical imaging colorization system of claim 9 , wherein the imaging analysis process is configured to identify different portions of the percutaneous medical device in relation to certain landmarks.
13. 13 . The medical imaging colorization system of claim 9 , wherein the medical imaging is ultrasound imaging.
14. 14 . The medical imaging colorization system of claim 9 , wherein the percutaneous medical device includes one or more of a biopsy device, a needle, a vacuum-assisted device, a clip or marker, an RFID clip or marker, a vascular access device, a stent, a filter, an angioplasty, a drain, or a catheter.
15. 15 . The medical imaging colorization system of claim 9 , wherein: performing the imaging analysis process further includes obtaining one or more dimension of the percutaneous medical device; and the identifying is further based on the one or more dimension, such that the imaging analysis process is configured to identify a portion having a region that is not visible in the medical imaging.
16. 16 . The medical imaging colorization system of claim 9 , wherein: performing the imaging analysis process further includes obtaining an identification of one or more of the percutaneous medical device or a procedure to be performed; and the identifying is further based on the identification.
17. 17 . A computer-implemented method of visualizing a percutaneous medical device, comprising: obtaining medical imaging of the percutaneous medical device within a body of a patient, the percutaneous medical device including a plurality of portions, each portion configured to have a unique visualization under medical imaging, wherein the unique visualization is caused by one or more of: foci positioned at predetermined regions of the plurality of portions; or a different proportion of microbubbles of a visualization material mixed with a biocompatible material; identifying one or more of the plurality of portions, by: mapping the unique visualizations of the one or more portions to predetermined detection targets; and identifying a respective portion label associated with each mapped predetermined detection target; applying different coloring to each of the one or more portions in the medical imaging based on the identifying; and causing a display to output the medical imaging that includes the different coloring.
18. 18 . The computer-implemented method of claim 17 , wherein identifying one or more of the plurality of portions includes applying a machine-learning model to the medical imaging, the machine-learning model having been trained based on medical imaging of medical devices with portions having different visualizations and training labels for the portions.
19. 19 . The computer-implemented method of claim 17 , wherein: the medical imaging is ultrasound imaging; and the percutaneous medical device includes one or more of a biopsy device, a needle, a vacuum-assisted device, a clip or marker, an RFID clip or marker, a vascular access device, a stent, a filter, an angioplasty, a drain, or a catheter.
20. 20 . The computer-implemented method of claim 17 , wherein the predetermined detection targets include one or more of: a specific visual response of a material or coating; a specific surface disruption; a presence of a predetermined foci; or a presence of a predetermined surface contour.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of and claims the benefit of priority to U.S. patent application Ser. No. 18/560,215, entitled “SYSTEM FOR COLOR-CODING MEDICAL INSTRUMENTATION AND METHODS OF USE”, filed Nov. 10, 2023, which claims the benefit of priority under 35 U.S.C. 111 (a) to PCT Application No. PCT/US2022/012716, filed on Jan. 18, 2022, which claims the benefit of priority to U.S. Patent Application Ser. No. 63/285,240, filed Dec. 2, 2021, the contents of all of which are hereby incorporated in their entireties as if fully set forth herein. TECHNICAL FIELD The present disclosure relates generally to medical devices. More specifically, the present disclosure relates to color-coded instrumentation, such as biopsy needle assemblies configured for use with tissue biopsy devices. BACKGROUND OF THE DISCLOSURE Medical procedures are often performed inside the body where the target and/or the instrument are hidden from the naked eye. Ultrasound is often used to provide imaging inside the body before, during or after such procedures, but such imaging is often grayscale. It is difficult for laypersons and young trainees to properly appreciate details from these grayscale images. In fact, depending on the circumstances, even seasoned professionals may improperly glean certain shadows or tones in the grayscale images. This may present patient safety issues and lead to injury or death. It may also prolong the length of a procedure as the physician or operator struggles to properly position instruments. The quality of the imaging may also lead to missing suspicious lesions or yielding false negative biopsies. BRIEF DESCRIPTION OF THE DRAWINGS The embodiments disclosed herein will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. The drawings depict only typical embodiments, which embodiments will be described with additional specificity and detail in connection with the drawings in which: FIG. 1 is a perspective view of a biopsy needle device; FIG. 2 is a cross-sectional view of the biopsy needle device of FIG. 1 with the housing lid removed; FIG. 3 is a perspective view of a cannula of the biopsy needle device of FIGS. 1 and 2; FIG. 3A is a detail view of a distal end portion of the cannula of FIG. 3 taken through line 3A; FIG. 4 is a perspective view of a trocar of the biopsy needle device of FIGS. 1 and 2; FIG. 4A is a detail view of the distal end of the trocar; FIGS. 5A-B are perspective views of a color-coded biopsy needle; FIG. 6 is a schematic showing a system for color-coding; FIGS. 7A-B are photographs showing breast mass biopsy without and with color-coding; FIGS. 8A-B are photographs showing ultrasound-guided lymph node biopsy without and with color-coding; FIGS. 9A-B are a graph showing echogenicity of hardware coating vs. percentage of signal returned and another example of a biopsy device; FIG. 10 is an example of color-coding an RFID tag; and FIGS. 11A-B are examples of color-coding a textured needle and ultrasounds showing same. DETAILED DESCRIPTION As described herein, systems and techniques are provided for color-coding medical instruments to yield safer and more accurate results. To better appreciate the overall systems and methods, the disclosure will be primarily described in connection with a biopsy needle. It will be understood, however, that many variations and uses of these systems and techniques are possible. As such, the biopsy needle embodiments described herein is merely exemplary and non-limiting. Embodiments may be understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood by one of ordinary skill in the art having the benefit of this disclosure that the components of the embodiments, 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 various embodiments, as represented in the figures, is not intended to limit the scope of the disclosure, but is merely representative of various embodiments. While the various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated. It will be appreciated that various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. Many of these features may be used alone and/or in combination with one another. The phrases “coupled to” 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 coupled to or in communication with each other even though they are not in direct contact with each other. For example, two components