IP Library Granted Patent US 12,402,953
Granted Patent B2
US 12,402,953 · App. 17/844,010 · Granted Sep 2, 2025

Insertion device positioning guidance system and method

Inventor: Doron Besser (Tel Aviv, IL)
Assignee: ENVUE MEDICAL HOLDINGS, CORP.
A61B34/20A61B5/062A61B5/743A61J15/0015A61J15/0088A61M25/0127A61M25/0158A61B1/273A61B5/0033A61B5/066A61B5/4233A61B2034/2051A61B2034/2072A61B2034/2074A61J15/0003
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Quick Facts
Patent No.
US 12,402,953
App. No.
17/844,010
Granted
Sep 2, 2025
Kind
B2
Abstract

There is provided herein a guidance system for positioning an insertion device comprising: an electromagnetic field generator configured to generate an electromagnetic field covering a treatment area, an insertion device comprising an electromagnetic sensor, the electromagnetic sensor configured to receive signals indicative of the electromagnetic field, and a processing circuitry configured to: load an X-ray, CT, ultrasound or MRI image of the subject's chest, mark a location of a first and a second anatomic landmarks on the subject's torso using a registration sensor and obtaining a subject coordinate system based thereon, identify the location of the first and the second anatomic landmarks on the loaded X-ray, CT, ultrasound or MRI image of the subject's chest; aligning the subject coordinate system with the loaded X-ray, CT, ultrasound or MRI image, and display, on the image, a path of the insertion device insertion with respect to the first and the second anatomic locations; wherein the path is generated according to changes in the strength of the electromagnetic field sensed by the tip sensor's during the insertion of the insertion device.

Claims (19)

1. A processing circuitry configured to:

load and display an X-ray, CT, ultrasound or MRI image of a subject's chest on the display;

receive from a registration sensor a location of a first and a second anatomic landmark on a subject's torso using a registration sensor,

identify the location of the first and the second anatomic landmarks on the loaded X-ray, CT, ultrasound or MRI image of the subject's chest; and

align the subject coordinate system with the loaded X-ray, CT, ultrasound or MRI image by aligning the registered first and second anatomic landmarks with the location of the first and second anatomic landmarks in the X-ray, CT, ultrasound or MRI image.

2. The processing circuitry of claim 1 , further configured to receive signals indicative of a strength of an electromagnetic field sensed by a tip sensor positioned on a distal end of an insertion tube.

3. The processing circuitry of claim 2 , wherein the electromagnetic field is generated by a field generated positioned externally to the subject's chest and wherein the electromagnetic field covers the subject's chest.

4. The processing circuitry of claim 2 , wherein the signals indicative of the strength of the electromagnetic field are obtained continuously during insertion of the insertion device.

5. The processing circuitry of claim 3 , further configured display, on the aligned X-ray, CT, ultrasound or MRI image, a path of the insertion device during its insertion; wherein the path is generated based on the aligned coordinate system, the first and the second anatomic locations and changes in the strength of the electromagnetic field sensed by the tip sensor's during the insertion.

6. The processing circuitry of claim 1 , wherein the identifying of the first and the second anatomic landmarks on the loaded X-ray, CT, ultrasound or MRI image is automatic and comprises applying image analysis algorithms on the loaded X-ray, CT, ultrasound or MM image.

7. The processing circuitry of claim 1 , wherein the identifying of the first and the second anatomic landmarks on the loaded X-ray, CT, ultrasound or MRI image comprises marking the at least two anatomic locations using radiopaque markers, prior to the imaging.

8. The processing circuitry of claim 7 , wherein the markers are configured to sense the electromagnetic field and to serve as reference sensors based thereon.

9. The processing circuitry of claim 1 , wherein the identifying of the first and the second anatomic landmarks on the loaded X-ray, CT, ultrasound or MRI image comprises positioning at least two markers on the subject's torso prior to the imaging and calculating the position of the anatomical landmarks based thereon.

10. The processing circuitry of claim 1 , wherein said processing circuitry is further configured to load a predefined anatomical map representing a torso; and to align the map, prior to the loading of the image of the subject's chest.

11. The processing circuitry of claim 1 , wherein the first anatomic location is the suprasternal notch and the second anatomic location is the xiphoid process.

12. The processing circuitry of claim 1 , wherein the insertion device is a peripherally inserted central catheter (PICC).

13. The processing circuitry of claim 1 , wherein the insertion device is a feeding tube.

14. The processing circuitry of claim 1 , wherein the electromagnetic sensor is positioned at a distal tip of said insertion device.

15. The processing circuitry of claim 1 , wherein the electromagnetic sensor is a separate unit configured for being removably positioned within the insertion device.

Assignments (6)
CHANGE OF NAME Recorded May 12, 2025
From: ENVIZION HOLDINGS CORP.
To: ENVUE MEDICAL HOLDINGS, CORP.
Reel/Frame 071278/0556 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 28, 2025
From: ENVIZION MEDICAL LTD.
To: ENVIZION HOLDINGS CORP.
Reel/Frame 070365/0772 →
CHANGE OF NAME Recorded Feb 28, 2025
From: ENVIZION HOLDINGS CORP.
To: ENVUE MEDICAL HOLDINGS, CORP.
Reel/Frame 070366/0925 →
SECURITY INTEREST Recorded Nov 7, 2023
From: ENVIZION MEDICAL LTD.
To: ALPHA CAPITAL ANSTALT
Reel/Frame 065486/0113 →
SECURITY INTEREST Recorded Sep 20, 2023
From: ENVIZION MEDICAL LTD.
To: ALPHA CAPITAL ANSTALT
Reel/Frame 064961/0581 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 19, 2022
From: BESSER, DORON
To: ENVIZION MEDICAL LTD.
Reel/Frame 060243/0676 →
Continuity (5)
Continuation 17561620 · Dec 23, 2021
Continuation In Part 17328642 · May 24, 2021
Continuation 16561320 · Sep 5, 2019
Provisional Application 62746854 · Oct 17, 2018
Related Publication 20220313367A1 · Oct 6, 2022
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