I2 UPDATETM

Unique Solution for Brain Shift 

I2 UPDATE™ is designed to maintain image-guidance accuracy to better than 2mm throughout the surgical procedure (versus average brain shift error of 10mm). It updates throughout surgery, is AUTOMATED, and DOES NOT INTERRUPT the surgical workflow. I2  UPDATE is designed to be integrated into any image-guidance system and does not require intraoperative CT, MR or ultrasound imaging.

  • Seamless, non-intrusive, accurate MR updates of the evolving neurosurgical field.
  • Stereovision cameras mounted on surgical miscroscope capture sparse data to drive our 3D computational model.
  • <2 mm accuracy maintained throughout surgery.*
  • Automated, on-demand image updating.
  • Avoids any intraoperative imaging.
 

*Published data from an institutional IRB-approved clinical study using a prototype device.1,2

 

*Published data from an institutional IRB-approved clinical study using a prototype device: 1) Fan X, Roberts DW, Schaewe TJ, Ji S, Holton LH, Simon DA, Paulsen KD. Intraoperative image updating for brain shift following dural opening. J Neurosurg 126:1924-1933, 2017. PubMed PMID: 27611206. PMCID: PMC5549265., and 2) Fan X, Roberts DW, Olson JD, Ji S, Schwaewe, Simon DA, Paulsen KD. Image updating for brain shift compensation during resection. Operative Neurosurgery 14:402-411, 2018. DOI: 10.1093/ons/opx123.

 

Intraoperative Updating of MRI Data

Early resection

Mid-resection

End of resection

These images show an intraoperatively updated MRI, using an institution IRB-approved (not FDA-approved) prototype device in an investigational study. The coronal MR images correspond to data available for display during the early, middle and final stages of tumor resection surgery.

The yellow lines, which would not be shown on the image-guidance system’s display, are the superimposed data collected during surgery to produce the updated MRI in the above institutional IRB-approved investigational study.

 

Seeing is Believing

The image (left) shows the surgical field viewed through an operating microscope superposed on the co–registered preoperative MRI (gray scale) corresponding to the surgical field.

  • Veins shown in white on the MRI should directly align with those same veins seen through the operating microscope, but as depicted at the white arrows, they do not.
  • The error is approximately 3-4 mm in this case and is a result of a brain shift and deformation of the brain during surgery as well as initial co-registration error.

The image (right) shows the same superposition of the microscope view of the surgical field on the corresponding MRI but here the MR image has been updated by an institutional IRB-approved prototype device (not I2 UPDATE). Now, the misaligned veins on the left align accurately (< 1 mm) on the right (white arrows in the two views).

With coventional imaging approach

With updating

Updating technology compensates for non-rigid deformation and is not simply a translation or rotation of preoperative MRI, neither of which (alone or together) achieves this degree of accuracy. The updating occurs throughout the brain volume, not just on the cortical surface.

 

I2 UPDATE’s presentation of MRI for image-guidance is designed to automatically and continuously update throughout the case without surgeon intervention or disruption of the surgical work flow.

Clinical Research Demonstrates Updating Technology’s Ability to Compensate for Brain Shift During Tumor Resection

In an investigative study referenced earlier1, an institutional IRB-approved (not FDA-approved] prototype (not I2 UPDATE ) using this technology looked at the comparative accuracy of the device. The graph compares “updated” accuracy versus a commercially-available, conventional image-guidance system in 20 open cranial procedures for tumor resection. Although the conventional system was accurate prior to the start of surgery, once the craniotomy began, its average accuracy was 7.3 ± 2.8 mm. The concurrent “updated” accuracy was 1.6 ± 0.4 mm.

In an investigative study referenced earlier [Fan, JNS 2017], an institutional IRB-approved (not FDA-approved] prototype (not I2 UPDATE ) using this technology looked at the comparative accuracy of the device. The graph compares “updated” accuracy versus a commercially-available, conventional image-guidance system in 20 open cranial procedures for tumor resection. Although the conventional system was accurate prior to the start of surgery, once the craniotomy began, its average accuracy was 7.3 ± 2.8 mm. The concurrent “updated” accuracy was 1.6 ± 0.4 mm.

In another institutional IRB-approved study using the prototype system (not I2 UPDATE ) in a series of 14 patients, the accuracy of both conventional image-guidance and the “updating” prototype was assessed both after dural opening near the start of surgery and later during tumor resection.2 As in the earlier study, the updating system was much more accurate early in the case (1.7 ± 0.3 mm vs. 8.5 ± 0.4 mm). Late in the case, the updating system remained accurate, while conventional image-guidance was not (1.9 ± 0.5 mm vs. 8.6 ± 4.7 mm).

In another institutional IRB-approved study using the prototype system (not I2 UPDATE ) in a series of 14 patients, the accuracy of both conventional image-guidance and the “updating” prototype was assessed both after dural opening near the start of surgery and later during tumor resection (Fan et al, 2019). As in the earlier study, the updating system was much more accurate early in the case (1.7 ± 0.3 mm vs. 8.5 ± 0.4 mm). Late in the case, the updating system remained accurate, while conventional image-guidance was not (1.9 ± 0.5 mm vs. 8.6 ± 4.7 mm).

Improved Surgical Accuracy

The figure to the right shows the display of an image-guidance system during surgery after bone removal and dural opening, with the top half using conventional (uncorrected) image guidance and the bottom half using updating technology (not I2 UPDATE).

The green cross-hairs represent the position of a tracked surgical instrument touching the tumor. Note that the cross hairs should be on the surface of the tumor (in white) as seen in the bottom orthogonal image panel display using updating, and not on the surface of the scalp as shown erroneously in the upper images using conventional image guidance.