Compartment syndrome monitoring systems and methods

• US 10,165,956 B2
• Filed: 04/15/2016
• Issued: 01/01/2019
• Est. Priority Date: 07/08/2010
• Status: Active Grant

• Current Assignee: TCI3-Pressure Applications LLC
• Original Assignee: TCI3-Pressure Applications LLC
• Inventors: Jacofsky, Marc C., Jacofsky, David J., Peeters, John P.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US15/130,625
• Publication Number:
  US 20160331253A1
• Time in Patent Office: 991 Days
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/168 Fluid filled sensor housings
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/4519 Muscles A61B5/389, A61B5/224 take precedence
• CPC Class Codes: A61B 5/6828 Leg
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B

Abstract

Embodiments of a compartment monitor that can be implanted and left in situ to continuously (or semi-continuously) measure compartment pressures are presented. An exemplary monitor includes a pressure sensor adapted to be implanted in a compartment, a transmitter external to the compartment and coupled to the pressure sensor, and a receiver in communication with the transmitter to receive and process pressure data received from the transmitter. The monitor may also be configured to transmit measured pressure data to a networkable device. The networkable device can then communicate the patient'"'"'s status and condition to a healthcare provider through a local area network (LAN) or wide area network (WAN). This communication allows the healthcare provider to remotely monitor a patient. The networkable device, or associated computing system, can record and display trends in the pressure data over time, and log the data to the patient'"'"'s electronic health records.

Claims

1. A method for monitoring pressure within a muscle fascia compartment of a patient, comprising:

inserting a fluid-filled bulb through the patient'"'"'s skin into an interior of the muscle fascia compartment of the patient,

wherein the fluid-filled bulb is fluidly coupled by a fluid-filled tube extending through the patient'"'"'s skin to a pressure sensor, and wherein the pressure sensor is coupled to a skin patch removably attached to the patient'"'"'s skin by an adhesive;

measuring pressure data within the muscle fascia compartment by the pressure sensor; and

receiving and storing the measured muscle fascia compartment pressure data from the pressure sensor by a radio-frequency identification (RFD device coupled to the pressure sensor and the skin patch.

2. The method of claim 1, wherein inserting the fluid-filled bulb into the muscle fascia compartment comprises inserting the fluid-filled bulb into a leg of the patient.

3. The method of claim 2, wherein inserting the fluid-filled bulb into the leg of the patient comprises inserting the fluid-filled bulb into one of the anterior, lateral, deep posterior, and superficial posterior lower leg compartment of the patient.

4. The method of claim 1, wherein inserting the fluid-filled bulb into the muscle fascia compartment comprises inserting the fluid-filled bulb through a needle penetrating through the patient'"'"'s skin and into the muscle fascia compartment.

5. The method of claim 1, further comprising interrogating the RFID device with a wireless RFID reader and communicating the measured muscle fascia compartment pressure data to the wireless RFID reader.

6. The method of claim 1, wherein measuring the pressure data within the muscle fascia compartment comprises continuously measuring the pressure data within the muscle fascia compartment.

7. The method of claim 1, wherein measuring the pressure data within the muscle fascia compartment comprises measuring the pressure data within the muscle fascia compartment for more than twenty-four hours.

8. The method of claim 1, further comprising transferring the measured muscle fascia compartment pressure data to a computing system.

9. The method of claim 8, further comprising the computing system calculating trends in the measured muscle fascia compartment pressure data over time.

10. The method of claim 9, further comprising alerting a healthcare provider in response to a determination that the measured muscle fascia compartment pressure data is outside a predetermined range or in response to a determination that the pressure trend indicates pressure trending in an adverse direction.

11. The method of claim 1, further comprising removing the fluid-filled bulb from the muscle fascia compartment through the patient'"'"'s skin.

12. A system for monitoring pressure within a muscle fascia compartment of a patient, the system comprising:

a skin patch comprising an adhesive substrate configured to removably affix the skin patch to the patient'"'"'s skin;

a fluid pressure sensor housed within the skin patch and configured to measure muscle fascia compartment pressure data;

a radio-frequency identification (RFID) device housed within the skin patch and coupled to the pressure sensor, wherein the RFID device is configured to receive and store the muscle fascia compartment pressure data;

a fluid-fillable bulb configured to be inserted through the patient'"'"'s skin and into the muscle fascia compartment; and

a fluid-fillable tube configured to penetrate through the patient'"'"'s skin to fluidly couple the fluid-filled bulb implanted within the muscle fascia compartment with the pressure sensor housed within the skin patch.

13. The system of claim 12, wherein the muscle fascia compartment is in a leg of the patient.

14. The system of claim 12, wherein the bulb, tube, and pressure sensor of the system are configured such that an increase in pressure on the bulb within the muscle fascia compartment forces fluid into the tube and is registered at the pressure sensor housed within the skin patch.

15. The system of claim 12, further comprising a wireless RFID reader, wherein the RFID device is configured to transmit the stored muscle fascia compartment pressure data to the wireless RFID reader upon interrogation by the wireless RFID reader.

16. The system of claim 15, wherein the wireless RFID reader comprises one of a cell phone, a personal digital assistant, and a laptop computer.

17. The system of claim 15, wherein the wireless RFID reader is configured to process the muscle fascia compartment pressure data.

18. The system of claim 15, wherein the wireless RFID reader is configured to transfer the muscle fascia compartment pressure data to a computing system, wherein the computing system is configured to process the muscle fascia compartment pressure data, and wherein the computing system is configured to record and display trends in the muscle fascia compartment pressure data over time.

19. The system of claim 12, wherein the fluid pressure sensor and the RFID device are housed between an upper layer and the adhesive substrate of the skin patch.

20. A compartment syndrome monitoring system, comprising:

a fluid-fillable bulb configured to be implanted within a compartment of a muscle group in a leg surrounded by fascia;

a fluid-fillable tube coupled to the implantable fluid-fillable bulb and configured to penetrate through the skin of the leg to an exterior of the leg;

a fluid pressure sensor configured to be disposed exterior to the skin of the leg and coupled to the fluid-fillable bulb by the fluid-fillable tube;

an adhesive bandage configured to be coupled to the skin of the leg and the fluid pressure sensor;

a radio-frequency identification (RFID) device coupled to the fluid pressure sensor and the adhesive bandage and configured to record fluid pressure data measured by the fluid pressure sensor from the fluid-fillable bulb within the compartment of the muscle group in the leg;

an RFID reader configured to interrogate the RFID device to receive the recorded fluid pressure data from the RFID device; and

a computer system configured to;

receive from the RFID reader the recorded fluid pressure data measured by the fluid pressure sensor from the fluid-fillable bulb within the compartment of the muscle group in the leg;

record and display trends in the recorded fluid pressure data over time; and

alert a healthcare provider in response to a determination that the recorded fluid pressure data is outside of predetermined range.