Implantable vital sign sensor
Inventors
Jain, Apurva • Joseph, Jeffrey I. • DICCIANI, Nance • DEVINE, Denise • Demmer, David
Assignees
Publication Number
US-11330987-B2
Publication Date
2022-05-17
Expiration Date
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Abstract
An implantable vital sign sensor including a housing including a first portion, the first portion defining a first open end, a second open end opposite the first end, and a lumen there through, the first portion being sized to be implanted substantially entirely within the blood vessel wall of the patient. A sensor module configured to measure a blood vessel blood pressure waveform is included, the sensor module having a proximal portion and a distal portion, the distal portion being insertable within the lumen and the proximal portion extending outward from the first open end.
Core Innovation
An implantable vital sign sensor including a housing including a first portion, the first portion defining a first open end, a second open end opposite the first end, and a lumen there through, the first portion being sized to be implanted substantially entirely within the blood vessel wall of the patient. A sensor module configured to measure a blood vessel blood pressure waveform is included, the sensor module having a proximal portion and a distal portion, the distal portion being insertable within the lumen and the proximal portion extending outward from the first open end.
Real-time monitoring of a non-ambulatory patient's vital signs is typically achieved through non-invasive methods which are often cumbersome and unwieldy, and ambulatory monitoring is challenging owing to patient mobility and lack of supervision. Non-invasive devices are typically less accurate and less stable than implantable sensors, and existing short-term and long-term intravascular blood pressure sensors are prone to obstruct blood flow and cause endothelial cell injury, thrombosis, and emboli.
Claims Coverage
Independent claims identified: claim 1, claim 12, and claim 18. The extracted inventive features from these independent claims are provided below (15 inventive features).
Light source configured to emit light
a light source configured to emit light;
Diaphragm housing with transverse major longitudinal axes
a diaphragm housing having a first portion defining a first major longitudinal axis and a second portion defining a second major longitudinal axis, the second portion extending from the first portion with the second major longitudinal axis being transverse to the first major longitudinal axis;
Diaphragm spaced a predetermined distance and sealing lumen
a diaphragm, the diaphragm and the diaphragm housing being disposed at a distal end of the optical sensor, the diaphragm being spaced a predetermined distance away from the light source and configured to reflect light emitted from the light source, the diaphragm housing having a lumen extending through the first portion and the second portion, and the diaphragm being disposed at a distal end of the second portion to seal the lumen;
Sensor sized for insertion within blood vessel wall
at least a portion of the optical sensor being sized to be at least partially inserted within a wall of a blood vessel, the blood vessel being at least one from the group consisting of an artery and a vein;
Diaphragm deflectable to measure reflected light
the diaphragm being deflectable in response to blood pressure within the blood vessel, the optical sensor being configured to measure at least one property of the light reflected off of the diaphragm in response to the deflection of the diaphragm.
Beam splitter configured to split light into first and second beams
a beam splitter being configured to split the light emitted from the light source into a first beam of light and a second beam of light, the second beam of light being directed by the beam splitter toward the diaphragm;
First prism and second prism with beam splitter between
a first prism and a second prism, the beam splitter being disposed between the first prism and the second prism;
First beam directed toward prism(s)
the first beam of light being directed by the beam splitter toward at least one from the group consisting of the first prism and the second prism;
Confocal displacement sensor configured to measure reflected light properties
the confocal displacement sensor being configured to measure at least one property of the light reflected off of the diaphragm in response to the deflection of the diaphragm.
Wave plate disposed between beam splitter and diaphragm
a wave plate, the wave plate being disposed between the beam splitter and the diaphragm;
Spacer disposed between wave plate and diaphragm
a spacer, the spacer being disposed between the wave plate and the diaphragm;
Diaphragm housing configured to retain spacer and diaphragm
the diaphragm housing being configured to retain the spacer and the diaphragm;
Signal detector configured to measure light properties
a signal detector, wherein the signal detector is configured to measure at least one property of light;
Signal detector measuring size, wavelength, and intensity
the at least one property of light includes at least one from the group consisting of size, wavelength, and intensity;
Diaphragm configured for lumen insertion and deflection
a diaphragm configured to be inserted within a lumen of a blood vessel, the diaphragm being spaced a predetermined distance away from the light source and configured to reflect light emitted from the light source, the diaphragm being deflectable in response to blood pressure within the blood vessel, the diaphragm housing having a lumen extending through the first portion and the second portion, and the diaphragm being disposed at a distal end of the second portion to seal the lumen;
The independent claims recite an optical/confocal displacement sensor architecture combining a light source, a diaphragm housing with transverse longitudinal axes, a diaphragm spaced from and sealing a lumen, beam splitting and prism optics (with optional wave plate and spacer), a signal detector measuring light properties (size, wavelength, intensity), and a diaphragm configured to be inserted into a blood vessel wall and to deflect in response to blood pressure so that properties of reflected light can be measured.
Stated Advantages
May produce an accurate measurement of the intravascular blood pressure waveform without distortion and without compressing or flattening of the artery wall, the artery lumen, the vein wall, or the vein lumen.
The implanted pressure/force sensor remains stable over time and may require infrequent re-calibration using an external BP cuff measurement system as a reference.
Continuous monitoring of vital signs may help medical professionals detect clinically significant changes in patient physiology and vital sign trend data may be used to monitor and adjust medical and surgical therapy which may lead to decreased morbidity and mortality.
An SpO2 sensor configuration may produce a real-time photoplethysmography signal with a high signal-to-noise ratio and minimal motion artifact.
Documented Applications
Real-time monitoring, recording, storing and transmission of vital signs for ambulatory and non-ambulatory patients, including heart rate, blood pressure, blood pressure waveform, blood flow, respiratory rate, tidal volume, ECG, temperature, hemoglobin oxygen saturation, activity level, and body position.
Use of measured vital signs to alert, diagnose, and/or treat associated diseases or conditions and to provide diagnostic and/or therapeutic recommendations and/or therapies to the patient.
Detection, diagnosis, monitoring and management of myocardial ischemia and myocardial infarction using real-time ECG, blood pressure waveform, cardiac sounds, and pulse oximetry.
Detection, diagnosis, monitoring and management of congestive heart failure and pulmonary edema using real-time blood pressure waveform, cardiac and lung sounds, and pulse oximetry.
Diagnosis and management of hypertension using real-time analysis of the blood pressure waveform and adjustment of medical/drug/device therapy.
Detection and diagnosis of atrial fibrillation and supraventricular tachycardia using real-time ECG and arterial blood pressure waveform.
Diagnosis of acute bronchospasm (asthma) and large or small airway obstruction using cardiac, lung and upper airway sounds, blood pressure waveform, ECG, and pulse oximetry.
Diagnosis and monitoring of chronic obstructive pulmonary disease and respiratory failure using vital sign measurements including respiratory rate, minute ventilation, pulse oximetry, and ECG.
Use in intestinal diseases (Crohn's disease, ulcerative colitis, diverticulitis, ischemia) by monitoring vital sign changes such as bowel sounds, temperature, heart rate, blood flow, and hemoglobin oxygen saturation.
Diagnosis of pulmonary embolism by monitoring acute onset wheezing, respiratory rate, tachycardia, arrhythmias, right ventricle strain on EKG, hemoglobin oxygen saturation, stroke volume, cardiac output, and blood pressure.
Detection of hemorrhage or dehydration by monitoring increases in heart rate, peripheral vascular resistance, respiratory rate, and decreases in stroke volume, cardiac output, blood pressure, blood flow, and hemoglobin oxygen saturation.
Closed-loop therapeutic applications including recommending or automatically delivering medications, oxygen, electrical stimulation, pacemaker therapy, ventricular assist device therapy, drug infusion pump delivery, and other therapies based on measured vital signs and therapeutic algorithms.
Implantation around specific vessels (for example the internal thoracic (mammary) artery) and communication with external controllers (smartphone, tablet, smartwatch) for display, calibration, alerts, alarms, and remote monitoring.
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