IP Library Granted Patent US 12,279,914
Granted Patent B2
US 12,279,914 · App. 18/144,788 · Granted Apr 22, 2025

Internal bleeding detection, assessment and monitoring devices, systems and methods

Inventor: Clinton T. Siedenburg (Everett, WA)
Assignee: Stryker Corporation
A61B8/56A61B8/08A61B8/085A61B8/4236A61B8/5223A61B8/565A61B8/4483A61B8/54
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Quick Facts
Patent No.
US 12,279,914
App. No.
18/144,788
Granted
Apr 22, 2025
Kind
B2
Abstract

Internal bleeding systems, devices, and methods are disclosed that include a sensing module and a processing module. The sensing module has an ultrasound module and a communication module. The ultrasound module emits and receives ultrasound energy to and reflected from tissue in a patient and generates a reflected energy signal. The communication module transmits the reflected energy signal to the processing module. The processing module analyzes the reflected energy signal to determine if it indicates the presence of blood from internal bleeding in the patient.

Claims (70)

1. An internal bleeding detection device, comprising:

an emitter configured to emit ultrasound into a volume of a patient, the volume comprising at least one of a perihepatic space, a perisplenic space, a pericardium, or a pelvis of the patient;

a sensor configured to detect a first reflection of the ultrasound from the volume at a first time and to detect a second reflection of the ultrasound from the volume at a second time; and

a processor configured to:

generate, by analyzing the first reflection of the ultrasound, first voxels corresponding to respective sections of the volume at the first time;

determine, by analyzing the first voxels at the first time, that a first amount of free blood in the volume of the patient at the first time is less than a threshold amount by determining that less than a threshold number of the first voxels correspond to power levels that are less than a threshold power level;

generate, by analyzing the second reflection of the ultrasound, second voxels corresponding to the respective sections of the volume at the second time;

determine, by analyzing the second voxels at the second time after the first time, that a second amount of free blood in the volume of the patient at the second time is greater than the threshold amount by determining that greater than a threshold number of the second voxels correspond to power levels that are less than the threshold power level; and

in response to determining that the second amount of free blood in the volume of the patient at the second time is greater than the threshold amount, output an alert indicating internal bleeding in the volume.

2. The internal bleeding detection device of claim 1 , further comprising:

a pulser electrically coupled to the emitter and being configured to control a characteristic of the ultrasound by supplying energy to the emitter, the characteristic of the ultrasound comprising at least one of a waveform, a power, a frequency, a wavelength, or an amplitude.

3. The internal bleeding detection device of claim 1 , wherein the processor is further configured to:

determine, by analyzing the first voxels and the second voxels, a rate of change of the internal bleeding within the patient, and

wherein the processor is configured to output the alert indicating the internal bleeding in the volume further in response to determining that the rate of change of the internal bleeding is greater than a threshold rate of change.

4. A medical device, comprising:

an emitter configured to emit ultrasound into a volume of a patient;

a sensor configured to detect a reflection of the ultrasound from the volume; and

a processor configured to:

generate, by analyzing the reflection of the ultrasound from the volume, voxels corresponding to respective sections of the volume;

determine a number of voxels that have power levels below a threshold power level;

determine that the number of voxels that have power levels below the threshold power level is greater than a threshold number; and

in response to determining that the number of voxels that have power levels below the threshold power level is greater than the threshold number, output an alert indicating internal bleeding in the volume.

5. The medical device of claim 4 , further comprising:

a pulser electrically coupled to the emitter and configured to supply energy to the emitter,

wherein a characteristic of the ultrasound emitted by the emitter is dependent on the energy, the characteristic comprising at least one of a waveform, a power, a frequency, a wavelength, or an amplitude.

6. The medical device of claim 4 , further comprising:

a pulser electrically coupled to the emitter and configured to supply first energy to the emitter at a first time and second energy to the emitter at a second time, the first energy causing the emitter to emit the ultrasound at a first power level at the first time, the second energy causing the emitter to emit the ultrasound at a second power level at the second time,

wherein the processor is configured to generate the voxels by:

generating, by analyzing a reflection of the ultrasound at the first power level, a first portion of the voxels corresponding to a first portion of the sections, the first portion of the sections being at a first depth from the emitter; and

generating, by analyzing a reflection of the ultrasound at the second power level, a second portion of the voxels corresponding to a second portion of the sections, the second portion of the sections being at a second depth from the emitter, the second depth being different than the first depth.

7. The medical device of claim 4 , further comprising:

a transmitter configured to transmit, to an external device, an indication of the alert.

8. The medical device of claim 4 , wherein the processor is further configured to:

determine that a first voxel of the voxels is associated with a first power level;

determine that a second voxel of the voxels is associated with a second power level; and

map, based on a difference between the first power level and the second power level, a fluid within the volume.

9. The medical device of claim 4 , wherein the threshold power level is associated with a power level of free blood.

10. The medical device of claim 4 , wherein the threshold power level is lower than a power level associated with a tissue of the patient.

11. The medical device of claim 4 , the threshold number being a first threshold number, the alert is a first alert, the processor being further configured to:

determine that greater than a second threshold number of the voxels are associated with power levels that are below the threshold power level,

wherein the alert further indicates that the internal bleeding is associated with a severity associated with the second threshold number.

12. The medical device of claim 4 , the processor being further configured to:

determine a ratio of the number of the voxels associated with power levels that are below the threshold power level and a number of the voxels associated with power levels that are above the threshold power level;

and

output, to a user a visual or audible signal indicative of the ratio.

13. A method performed by a medical device, the method comprising:

emitting, by an emitter, ultrasound into a volume of a patient;

detecting, by a sensor, a reflection of the ultrasound from the volume;

generating, by a processor, voxels corresponding to respective sections of the volume;

determining a number of voxels that have power levels below a threshold power level;

determining, by the processor, that the number of voxels that have power levels below a threshold power level is greater than a threshold number; and

in response to determining that the number of voxels that have power levels below the threshold power level is greater than the threshold number, outputting an alert indicating internal bleeding in the volume.

14. The method of claim 13 , further comprising:

supplying energy to the emitter by a pulser electrically coupled to the emitter, wherein a characteristic of the ultrasound emitted by the emitter is dependent on the energy, the characteristic comprising at least one of a waveform, a power, a frequency, a wavelength, or an amplitude.

15. The method of claim 14 , wherein the pulser is configured to supply first energy to the emitter at a first time and second energy to the emitter at the second time, the first energy causing the emitter to emit the ultrasound at a first power level at the first time, the second energy causing the emitter to emit the ultrasound at a second power level at the second time, the method further comprising:

generating, by analyzing a reflection of the ultrasound at the first power level, a first portion of the voxels corresponding to a first portion of the sections, the first portion of the sections being at a first depth from the emitter; and

generating, by analyzing a reflection of the ultrasound at the second power level, a second portion of the voxels corresponding to a second portion of the sections, the second portion of the sections being at a second depth from the emitter, the second depth being different than the first depth.

16. The method of claim 13 , further comprising:

determining that a first voxel of the voxels is associated with a first power level;

determining that a second voxel of the voxels is associated with a second power level;

determining a difference between the first power level and the second power level; and

mapping, based on the difference between the first power level and the second power level, a fluid within the volume.

17. The method of claim 13 , wherein the threshold power level is associated with a power level of free blood.

18. The method of claim 13 , wherein the threshold power level is lower than a power level associated with a tissue of the patient.

19. The method of claim 13 , the threshold number being a first threshold number, the alert is a first alert, the method further comprising:

determining that greater than a second threshold number of the voxels are associated with power levels that are below the threshold power level,

wherein the alert further indicates that the internal bleeding is associated with a severity associated with the second threshold number.

20. The method of claim 13 , the method further comprising:

determining a ratio of the number of the voxels associated with power levels that are below the threshold power level and a number of the voxels associated with power levels that are above the threshold power level; and

outputting to a user a visual or audible signal indicative of the ratio.

Assignments (2)
CHANGE OF ADDRESS Recorded Dec 18, 2024
From: STRYKER CORPORATION
To: STRYKER CORPORATION
Reel/Frame 069737/0184 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 28, 2023
From: SIEDENBURG, CLINTON T.
To: STRYKER CORPORATION
Reel/Frame 064427/0686 →
Continuity (3)
Continuation 16103837 · Aug 14, 2018
Provisional Application 62545440 · Aug 14, 2017
Related Publication 20230355217A1 · Nov 9, 2023
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