Systems, methods, and devices for facilitating access to target anatomical sites or environments

Inventors

Hulvershorn, Justin • Schmidt, Karl • Swartz, Douglas

Assignees

Medline Industries LP • Mirador Biomedical Inc

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Publication Number

US-9888881-B2

Patent

Publication Date

2018-02-13

Expiration Date


Abstract

Methods and structures for detecting a physiologic parameter of a target anatomical environment. The device including a housing with a distal portion first port couplable to a probe and a proximal portion; and a sensing unit, a processing unit, and an output unit carried by the housing, the output unit configured to output a reporting signal based on the determined physiologic parameter value such as pressure; the sensing unit, processing unit, and output unit being disposed substantially between the first port and the proximal portion of the housing.

Core Innovation

The invention relates to an anatomical environment characterization device (AECD) configured as a medical device for characterizing a tissue environment about a distal portion of a probe. The device includes a housing with a first port detachably couplable to a probe and a proximal second port detachably couplable to a syringe, with the first port fluidly coupled to the second port. The housing is graspable by a user to manipulate the housing and the probe, positioning the distal portion within the tissue environment for measurement.

A pressure sensor carried by the housing generates a pressure signal in response to a pressure of the tissue environment in which the distal portion of the probe is positioned. The pressure signal comprises a series of instantaneous pressure values, which a processing unit receives and processes. The processing unit determines a pressure value using a moving average of the series over a time period, the pressure value being indicative of the tissue environment about the distal portion of the probe.

An output unit coupled to the processing unit and carried by the housing outputs the series of instantaneous pressure values and/or outputs a reporting signal. The output can include wirelessly outputting the series of instantaneous pressure values and remote reporting such as a second, remote visual display. In addition to pressure-based characterization, processing is described as determining additional physiological or clinical values from other signals, including oxygen saturation, electrocardiography values, and blood pressure values.

Claims Coverage

Across the provided material, there are three independent claims. The claims share a common structure: a housing that couples to a probe and generates pressure or tissue-pressure signals at the distal portion, a processing unit that converts a series of instantaneous pressure values into a moving-average-derived pressure value, and an output unit that outputs a reporting signal, including wireless output in some embodiments.

Moving-average pressure determination from instantaneous pressure values

A processing unit configured to receive and process the series of instantaneous pressure values so as to determine a pressure value using a moving average of the series over a time period, the pressure value indicative of the tissue environment about the distal portion of the probe.

Wirelessly outputting series of instantaneous pressure values

An output unit coupled to the processing unit and carried by the housing, the output unit configured to wirelessly output the series of instantaneous pressure values.

Tissue-pressure value determined using a moving average of instantaneous tissue pressure values

A processing unit configured to receive and process the series of instantaneous tissue pressure values so as to determine a tissue pressure value using a moving average of the series over a time period, the tissue pressure value indicative of the tissue environment about the distal portion of the probe.

Output unit configured to output a reporting signal

An output unit coupled to the processing unit and carried by the housing, the output unit configured to output a reporting signal.

Processing unit configured to process EKG signals from an EKG lead

A processing unit coupled to the fluid pressure sensor associated with the chamber to generate pressure signals, the processing unit configured to receive and process electrical signals from an external sensor, wherein the external sensor is an electrocardiography (EKG) lead that electrically communicates with the processing unit, wherein the processing unit is configured to process an EKG signal from the EKG lead.

The independent claims collectively cover a housing-based medical device that measures pressure or tissue pressure via instantaneous pressure values at a distal probe portion, computes a moving-average-derived pressure or tissue-pressure value to indicate the tissue environment, and outputs pressure-derived data or a reporting signal, including wireless output. A further independent claim extends the concept by processing electrical signals from an EKG lead in combination with pressure signals for reporting.

Stated Advantages

The device determines a pressure value indicative of the tissue environment about the distal portion of the probe using a moving average of instantaneous pressure values.

The device outputs the series of instantaneous pressure values and/or outputs a reporting signal, including wireless output and remote display.

Documented Applications

Verification of venous versus arterial access using sensed pressure characterization.

Lumbar puncture monitoring, including monitoring cerebrospinal fluid (CSF) opening pressure and closing pressure.

Epidural space detection based on pressure sensing and processing.

Thoracentesis pressure monitoring.

Compartment pressure monitoring.

Peripheral nerve block injection-pressure guidance based on injection-pressure threshold evaluation.

Evaluation of vascular properties including ABPI and dialysis access patency using pressure characterization.

Wireless monitoring/alerts and mode switching for monitoring and reporting.

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