Physiological sensor delivery device and method

• US 8,641,639 B2
• Filed: 06/13/2013
• Issued: 02/04/2014
• Est. Priority Date: 09/11/2008
• Status: Active Grant

• Current Assignee: ACIST Medical Systems Incorporated (Bracco SPA)
• Original Assignee: ACIST Medical Systems Incorporated (Bracco SPA)
• Inventors: Manstrom, Dale R., Raatikka, Amy R., Wilson, Robert F., Miller, Edward R., Pak, Jung Kwon
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US13/917,354
• Publication Number:
  US 20130331714A1
• Time in Patent Office: 236 Days
• Field of Search: 600/485, 600/486, 600/504, 600/505, 600/561
• US Class Current: 600/561
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0017 transmitting optical signals transmission by light H04B10/00
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/02154 by optical transmission
• CPC Class Codes: A61B 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/6851 Guide wires
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/6862 Stents
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 6/507 for determination of haemodynamic parameters, e.g. perfusion CT
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0034 : characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0037 : characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0183 : Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/091 : having a lumen for drug delivery or suction
• CPC Class Codes: A61M 25/0029 : characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0067 : characterised by the distal end, e.g. tips A61M25/0054, A61M25/04 take precedence; balloon catheters A61M25/10
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/09 : Guide wires
• CPC Class Codes: A61M 5/007 : for contrast media

Abstract

An intravascular sensor delivery device for measuring a physiological parameter of a patient, such as blood pressure, within a vascular structure or passage. In some embodiments, the device can be used to measure the pressure gradient across a stenotic lesion or heart valve, such as a fractional flow reserve (FFR) across a stenotic lesion. The sensor delivery device has a distal sleeve configured to pass or slide over a standard medical guidewire. The sensor delivery device can be sized to pass over different sizes of guidewires to enable usage in coronary and peripheral arteries, for example. The sensing mechanism (sensor) can be a fiber optic pressure sensor, such as a MEMS-based FabryPerot fiber optic pressure sensor, for example, or could employ some other technology, e.g., MEMS capacitive or piezoresistive sensor.

Claims

1. A fluid injection system comprising:

fluid tubing adapted to provide fluid communication between the injection system and a patient;

a control panel; and

a processor;

wherein the processor is adapted to receive;

(a) a first signal representative of a first blood pressure measured upstream of a location of interest in the patient during a phase of a cardiac cycle, the first signal being generated with a hemodynamic transducer or a sensor coupled to an intravascular sensor delivery device, and

(b) a second signal representative of a second blood pressure measured downstream of the location of interest in the patient in substantially the same phase of the cardiac cycle as the first signal, the second signal being generated by the sensor,

wherein the control panel is adapted to display information derived from the first and second signals, and

wherein the intravascular sensor delivery device comprises a distal sleeve and a proximal portion, the distal sleeve having a guidewire lumen for sliding over and receiving a separate medical guidewire and being insertable in a leading direction into a body of the patient, the proximal portion having a main section extending proximally from the distal sleeve and a distal transition extending distally from the main section, wherein the distal transition is fixedly coupled to an outer surface of the distal sleeve, the proximal portion comprises a communication channel for communicating at least one of the first signal and second signal from the sensor to a location outside of the patient, and the proximal portion is adapted to facilitate positioning of the sensor within an anatomical structure of the patient.

2. The system of claim 1, wherein the processor is adapted to calculate fractional flow reserve (FFR) based on a ratio of the first signal to the second signal, and wherein the control panel is adapted to display information related to the calculated FFR.

3. The system of claim 2, wherein the control panel provides an indication of whether the FFR is below a threshold value.

4. The system of claim 3, wherein the threshold value is about 0.75.

5. The system of claim 1, wherein the first signal is generated by the sensor.

6. The system of claim 1, wherein the first signal is a fluid pressure signal communicated to the fluid injection system using the fluid tubing.

7. The system of claim 1, wherein the first blood pressure and the second blood pressure are measured substantially simultaneously.