IP Library Granted Patent US 12,440,285
Granted Patent B2
US 12,440,285 · App. 17/156,321 · Granted Oct 14, 2025

Prediction of hemostasis issues based on biomarker monitoring

Inventors: Frederick E. Shelton, IV (Hillsboro, OH); Jason L. Harris (Lebanon, OH); Chad Edward Eckert (Terrace Park, OH)
Assignee: Cilag GmbH International
A61B34/25A61B17/12A61B17/320092A61B2017/00026A61B2017/00044A61B2017/00115A61B2017/00199A61B2017/12004A61B2017/320093A61B2017/320097A61B2034/252
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Quick Facts
Patent No.
US 12,440,285
App. No.
17/156,321
Filed
Jan 22, 2021
Granted
Oct 14, 2025
Kind
B2
Art Unit
3771
USPC
606/167
Abstract

A computing system may predict a complication based on measurements of related biomarker(s) obtained via one or more sensing systems, and generate an adjustment of a surgical parameter associated with a surgery. The biomarker measurements may include pre-surgical and/or in-surgical measurements. The hemostasis-related biomarker(s) measured pre-surgery may include blood pressure, blood pH, edema, heart rate, blood perfusion rate, coagulation status and/or the like. Based on the prediction, the computing system may generate a control signal configured to alter a matter in which a surgical cutting and stapling device and/or a surgical energy operate, to adjust a surgical procedure plan, to adjust to a surgical instrument selection, indicate a probability of the hemostasis complication, and/or to indicate a suggested adjustment to surgical procedure plan, surgical approach, and/or surgical instrument selection.

Claims (62)

1. A computing system comprising a processor configured to at least:

obtain, via at least one sensing system, measurement data associated with at least one patient biomarker;

determine mental state data and physical state data, wherein the mental state data and the physical state data are associated with a healthcare professional (HCP);

determine a bleeding event probability and a clotting event probability based on the measurement data, the mental state data, and the physical state data;

determine a risk score trend based on the bleeding event probability and the clotting event probability, wherein the risk score trend indicates a likelihood of an adverse surgical outcome;

predict a hemostasis complication when the risk score trend exceeds a threshold;

generate a first control signal to mitigate the hemostasis complication and the adverse surgical outcome, wherein the first control signal indicates a location of tissue at risk of the hemostasis complication;

generate a second control signal to mitigate the hemostasis complication and the adverse surgical outcome by adjusting a parameter of a surgical device based on the mental state data and the physical state data; and

send the first control signal to a display and the second control signal to the surgical device.

2. The computing system of claim 1 , wherein adjusting the parameter comprises at least one of:

adjusting a power level;

adjusting an energy level;

adjusting a tissue impedance threshold associated with an energy mode change trigger;

increasing a jaw compression force;

increasing a compression time; or

prolonging a wait time.

3. The computing system of claim 1 , wherein the surgical device is a surgical cutting and stapling device, and wherein adjusting the parameter comprises at least one of:

increasing a pre-deployment compression;

slowing a firing actuator speed;

combining a plurality of pauses in advancing actuators; or

adjusting viable staple height zones.

4. The computing system of claim 1 , wherein the processor is further configured to:

detect an increased blood clot formation risk based on the clotting event probability;

in response to the detection of the increased blood clot formation risk, generate a third control signal to mitigate the increased blood clot formation risk by adjusting a second parameter of a second surgical device, wherein the second parameter comprises at least one of:

a clamping duration;

a compression duration;

an amount of power activation; or

a duration of power activation.

5. The computing system of claim 1 , wherein the hemostasis complication is a first hemostasis complication, and wherein the processor is configured to:

predict a second hemostasis complication when the clotting event probability exceeds a clotting event probability threshold.

6. The computing system of claim 1 , wherein the measurement data is associated with at least one of: blood pressure, blood pH, edema, or heart rate.

7. The computing system of claim 1 , wherein the hemostasis complication comprises at least one of: bleeding from mobilization, bleeding from transection, fluid oozing from mobilization, fluid oozing from transection, weeping from mobilization, weeping from transection, thrombosis, thromboembolism, or irregular blood clotting.

8. The computing system of claim 1 , wherein the first control signal further indicates an adjustment to an instrument selection, the adjustment comprising at least one of:

selecting a small surgical cutting and stapling device in place of a large surgical cutting and stapling device;

selecting a surgical cutting and stapling device in place of an energy device;

adding a buttress to the instrument selection;

adding force supplementing adjuncts to the instrument selection;

adding one or more hemostatic adjuncts to the surgical device;

selecting a staple cartridge associated with a smaller staple height; or

selecting an improved hemostasis energy device in place of an energy device associated with low hemostasis capability.

9. The computing system of claim 1 , wherein the first control signal further indicates an adjustment to a surgical procedure plan, the adjustment comprising at least one of:

reducing a volume of anesthesia fluids; or

reducing a volume of a post-surgical fluid prescription.

10. A sensing system comprising:

at least one sensor for measuring at least one biomarker;

a processor configured to:

obtain measurement data associated with the at least one biomarker;

determine mental state data and physical state data, wherein the mental state data and the physical state data are associated with a healthcare professional (HCP);

determine a bleeding event probability and a clotting event probability based on the measurement data, the mental state data, and the physical state data;

determine a risk score trend based on the bleeding event probability and the clotting event probability, wherein the risk score trend indicates a likelihood of an adverse surgical outcome;

predict a hemostasis complication when the risk score trend exceeds a threshold;

generate a first control signal to mitigate the predicted hemostasis complication and the adverse surgical outcome, wherein the first control signal indicates a location of tissue at risk of the hemostasis complication;

generate a second control signal to mitigate the hemostasis complication and the adverse surgical outcome by adjusting a parameter of a surgical device based on the mental state data and the physical state data; and

send the first control signal to a display and the second control signal to the surgical device.

11. The sensing system of claim 10 , wherein the measurement data comprises at least one of pre-surgical measurement data or in-surgical measurement data associated with the at least one biomarker, and wherein the at least one biomarker comprises at least one of blood pressure, blood pH, edema, or heart rate.

12. The sensing system of claim 10 , wherein the processor is further configured to:

detect an increased blood clot formation risk based on the measurement data associated with the at least one biomarker;

in response to the detection of the increased blood clot formation risk, generate a third control signal to mitigate the increased blood clot formation risk by adjusting a second parameter of the surgical device, wherein the second parameter comprises at least one of:

a clamping duration;

a compression duration;

an amount of power activation; or

a duration of power activation.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 27, 2021
From: ETHICON LLC
To: CILAG GMBH INTERNATIONAL
Reel/Frame 056601/0339 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 24, 2021
From: SHELTON, FREDERICK E., IV; HARRIS, JASON L.; ECKERT, CHAD E.
To: ETHICON LLC
Reel/Frame 055392/0384 →
Continuity (1)
Related Publication 20220233254A1 · Jul 28, 2022
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