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EP-4061466-B1 - OPTICAL TIP-TRACKING SYSTEMS

EP4061466B1EP 4061466 B1EP4061466 B1EP 4061466B1EP-4061466-B1

Inventors

  • MISENER, Anthony Kent

Dates

Publication Date
20260513
Application Date
20201125

Claims (14)

  1. An optical tip-tracking system (100;200), comprising: a light-emitting stylet (110) configured to be disposed in a lumen of a catheter (450), the light-emitting stylet including a light source in a distal-end portion of the light-emitting stylet configured to emit light; a light detector (120) configured to be placed over a patient, the light detector including a plurality of photodetectors configured to detect the light emitted from the light source; and a console (130;230) configured to operably connect to the light-emitting stylet and the light detector, the console including memory (134) and a processor (132) configured to instantiate an optical tip-tracking process for optically tracking the distal-end portion of the light-emitting stylet while the light-emitting stylet is disposed in a vasculature of the patient, the light source is emitting light, the light detector is disposed over the light-emitting stylet, and the photodetectors are detecting the light emitted from the light source; wherein the photodetectors are arranged in an array such that the light emitted from the light source remains detectable by at least one photodetector of the photodetectors even when the light emitted from the light source is anatomically blocked from another one or more photodetectors of the photodetectors.
  2. The optical tip-tracking system of claim 1, wherein the light source is a light-emitting diode, LED.
  3. The optical tip-tracking system of either claim 1 or 2, wherein the light emitted from the light source has a center wavelength between 650 nm to 1350 nm.
  4. The optical tip-tracking system of either claim 1 or 2, wherein the light emitted from the light source has a center wavelength between 650 nm to 950 nm.
  5. The optical tip-tracking system of any claim of claims 1-4, wherein the distal-end portion of the light-emitting stylet is configured to directionally emit light in one or more chosen directions.
  6. The optical tip-tracking system of any claim of claims 1-5, wherein the light detector includes a housing having a patient-facing portion (772) of the housing configured to transmit at least a portion of the light emitted from the light source to the photodetectors.
  7. The optical tip-tracking system of claim 6, wherein the housing has a light blocking portion (724) of the housing opposite the patient-facing portion configured to block ambient light from the photodetectors.
  8. The optical tip-tracking system of any claim of claims 1-7, wherein the optical tip-tracking process is configured to provide tracking information as input to a display server of the console for optically tracking the distal-end portion of the light-emitting stylet in a graphical user interface on a display.
  9. The optical tip-tracking system of any claim of claims 1-8, wherein the light-emitting stylet is configured to directly connect to the console.
  10. The optical tip-tracking system of any claim of claims 1-8, wherein the light-emitting stylet is configured to indirectly connect to the console through an intervening multi use cable.
  11. The optical tip-tracking system of any claim of claims 1-8, wherein the light-emitting stylet is configured to indirectly connect to the console through the light detector; and optionally wherein the light detector is configured to be placed over the patient and under a sterile drape (801), the light-emitting stylet including a drape-piercing connector having a piercing element configured to pierce the sterile drape and insert into a receptacle of a light-detector connector extending from the light detector under the drape.
  12. An optical tip-tracking system (100;200), comprising: a catheter (450) including a lumen extending through the catheter; and the optical tip-tracking system according to claim 2, wherein the light-emitting stylet is configured to emit light having a center wavelength between 650 nm to 1350 nm; wherein the plurality of photodetectors are arranged in an array; and wherein the memory (134) and processor (132) are configured to instantiate an optical tip-tracking process for optically tracking the distal-end portion of the light-emitting stylet on a graphical user interface on a display (140) while the light-emitting stylet is disposed in a vasculature of the patient, the LED is emitting light, the light detector is disposed over the light-emitting stylet, and the photodetectors are detecting the light emitted from the LED.
  13. The optical tip-tracking system of claim 12, wherein the light detector is configured to be placed over the patient and under a sterile drape (801), the light-emitting stylet including a drape-piercing connector configured to pierce the sterile drape and connect with a light-detector connector extending from the light detector under the drape.
  14. An optical tip-tracking system (100;200), comprising: a light-emitting stylet configured to be disposed in a lumen of a catheter, the light-emitting stylet (110) including an optical fiber (615) configured to convey light to a distal-end portion of the light-emitting stylet for emitting light therefrom; a light detector configured to be placed over a patient, the light detector including a plurality of photodetectors configured to detect the light emitted from the light source; and a console (130;230) configured to operably connect to the light-emitting stylet and the light detector, the console including: a light source for the light emitting stylet; and memory (134) and a processor (132) configured to instantiate an optical tip-tracking process for optically tracking the distal-end portion of the light-emitting stylet while the light-emitting stylet is disposed in a vasculature of the patient, the light source is emitting light, the light detector is disposed over the light-emitting stylet, and the photodetectors are detecting the light emitted from the light source; wherein the photodetectors are arranged in an array such that the light emitted from the light source remains detectable by at least one photodetector of the photodetectors even when the light emitted from the light source is anatomically blocked from another one or more photodetectors of the photodetectors.

Description

PRIORITY This application claims the benefit of priority to U.S. Patent Application No. 62/940,107 filed November 25, 2019. BACKGROUND Intravascular guidance of medical devices such as guidewires and catheters typically requires fluoroscopic methods for tracking tips of the medical devices and determining whether the tips are appropriately localized in their target anatomical structures. Such fluoroscopic methods expose clinicians and patients alike to harmful X-ray radiation. In some cases, the patients are exposed to potentially harmful contrast media needed for the fluoroscopic methods. Magnetic and electromagnetic means for tracking the tips of the medical devices obviate some of the foregoing issues with respect to exposure to radiation and potentially harmful contrast media, but the magnetic and electromagnetic means for tracking the tips of the medical devices are prone to interference. US 2018/289927 A1 discloses a placement system for tracking, placing, and monitoring a catheter assembly or other medical device inserted into a body of a patient. The system comprises a console including a light source, and a plurality of optical fiber-based strain sensors in the catheter. In use, light from the light source is transmitted into and along the optical fiber. Signals from the optical fiber-based strain sensors are reflected back to a photodetector, the signals indicating a strain level of a respective strain sensor. From the strain data from multiple strain sensors, an overall shape of the catheter is determined. US 2008/0039715 A1 discloses a system comprising an optically-guided catheter. Light emitting means is coupled to the catheter and light is emitted from one or more points of the catheter, usually the distal tip. An external detection device is provided to detect transdermally projected light from the catheter, which can thereby indicate precise placement of the catheter within the patient. Disclosed herein are optical tip-tracking systems and methods thereof that address the foregoing. SUMMARY The invention is defined in independent claim 1. Certain optional features of the invention are defined in the dependent claims. Disclosed herein is an optical tip-tracking system including, in some embodiments, a light-emitting stylet, a light detector, and a console configured to operably connect to the light-emitting stylet and the light detector. The light-emitting stylet is configured to be disposed in a lumen of a catheter. The light-emitting stylet includes a light source in a distal-end portion of the light-emitting stylet configured to emit light. The light detector is configured to be placed over a patient. The light detector includes a plurality of photodetectors configured to detect the light emitted from the light source. The console includes memory and a processor configured to instantiate an optical tip-tracking process for optically tracking the distal-end portion of the light-emitting stylet while the light-emitting stylet is disposed in a vasculature of the patient, the light source is emitting light, the light detector is disposed over the light-emitting stylet, and the photodetectors are detecting the light emitted from the light source. In some embodiments, the light source is a light-emitting diode ("LED"). In some embodiments, the light emitted from the light source has a center wavelength between about 650 nm to 1350 nm. In some embodiments, the light emitted from the light source has a center wavelength between about 650 nm to 950 nm. In some embodiments, the distal-end portion of the light-emitting stylet is configured to directionally emit light in one or more chosen directions. In some embodiments, the light detector includes a housing having a patient-facing portion of the housing configured to transmit at least a portion of the light emitted from the light source to the photodetectors. In some embodiments, the housing has a light-blocking portion of the housing opposite the patient-facing portion configured to block ambient light from the photodetectors. The photodetectors are arranged in an array such that the light emitted from the light source remains detectable by at least one photodetector of the photodetectors even when the light emitted from the light source is anatomically blocked from another one or more photodetectors of the photodetectors. In some embodiments, the optical tip-tracking process is configured to provide tracking information as input to a display server of the console for optically tracking the distal-end portion of the light-emitting stylet in a graphical user interface on a display. In some embodiments, the light-emitting stylet is configured to directly connect to the console. In some embodiments, the light-emitting stylet is configured to indirectly connect to the console through an intervening multi-use cable. In some embodiments, the light-emitting stylet is configured to indirectly connect to the console through the light detector. In some embo