Products



Overview





Copernicus Surgical's flagship product, Tissue Probe, is not a therapeutic or diagnostic device but an analytical device for intraoperatively acquiring a quantitative measure of tissue characteristics, which is needed by a surgeon in following the instructions of a stapler to prevent stapler malfunctions and failures, most often, resulting from device overloading.



Value





As part of the labeling for the advanced surgical staplers to be developed as proposed in the STeP application to FDA the load capacity of surgical stapler as well the maximum compression tolerable for tissue will be provided that would help significantly enhance safety and effectiveness of surgical staplers when complemented by the Tissue Probe line of products.



Beyond





The Tissue Probe line of products would also be an essential part of Galileo Surgical Innovation's effort to address the other surgical stapler problems, staple line leaks, occurring postoperatively.



Tissue Probe prototype under test



  • Measured Quantity: Reactionary force per unit area at a given tissue thickness
  • Granted a Breakthrough Device Designation by FDA in 2019
  • 5 U.S. patents issued
  • Additional patentable subjects in preparation


Tissue Probe - Overload Protector*



  • Measured Quantity: Boolean determination if reactionary force per unit area at a given tissue thickness exceeds the rated load of the stapler
  • Helps prevent stapler malfunction or failure due to the stapler overload by tissue


Tissue Probe - Discriminator*



  • Measured Quantity: Boolean determination if reactionary force per unit area at a given tissue thickness falls within a preset window
  • A first quantitative basis for selection of staple type for target tissue
  • Helps assess hemostasis performance of a selected staple & prevent stapler overloading


Tissue Probe - Comparator*



  • Measured Quantity: Tissue thickness at a given reactionary force per unit area
  • A second quantitative basis for selection of staple type for target tissue


Tissue Probe - Analyzer*



  • Measured Quantity: Compressive elastic property of tissue at a given thickness
  • A third quantitative basis for selection of staple type for target tissue


Remedial Stapler*



  • Staples tissue to a given compression level
  • Topical reinforcement of staple line to guard against physiological load (organ motion)
  • Stapling of off-label thickness tissue
  • Remedial stapling of sub-optimal portions of a staple line


Proposed staple type selection procedure using Tissue Probe - Discriminator



(1) Manufacturer of a surgical stapler specifies the load capacity in terms of maximum and minimum (8 g/mm2) reactionary force per unit area.

(2) Using Tissue Probe - Discriminator reactionary force per unit area from tissue compressed to the closed height of each staple type is measured.

(3) The surgeon selects a staple type providing reactionary force per unit area that falls within the specified load capacity of the surgical stapler.



Correlation between tissue compression and sealing performance of staple line



Stapling significantly alters mechanical properties of tissue including its ability to stretch/contract in the direction parallel to the staple line, which can impact the sealing performance of staple line near the exposed ends, e.g., the gastroesophageal junction in the stomach and the corners created in wedge resection in the lung.

The level of tissue compression, measurable intraoperatively using Tissue Probe - Indicator, is a parameter that closely correlates with the tissue's ability to stretch/contract in the direction parallel to the staple line.

Therefore, the correlation between staple type selection and sealing performance of staple line near the exposed ends could be systematically investigated with the use of Tissue Probe - Discriminator.



* The products displayed on this website are under development and have not been cleared or approved for marketing by any regulatory agency. The contents of this website may be updated in the future without prior notice.