Device for measuring a plurality of parameters in patient subject to a treatment with radiopharmaceuticals

• US 10,722,171 B2
• Filed: 02/16/2015
• Issued: 07/28/2020
• Est. Priority Date: 02/17/2014
• Status: Active Grant

• Current Assignee: ab medica SpA
• Original Assignee: Winmedical S.R.L. (AB Medica Holding Srl)
• Inventors: Valdastri, Pietro, De Negri, Ferdinando
• Primary Examiner(s): Turchen, Rochelle D
• Application Number:
  US15/116,330
• Publication Number:
  US 20170007177A1
• Time in Patent Office: 1,989 Days
• CPC Class Codes: A61B 2560/0456 Apparatus provided with a docking unit
• CPC Class Codes: A61B 2562/06 Arrangements of multiple sensors of different types
• CPC Class Codes: A61B 2562/18 Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/48 Other medical applications
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/6801 specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6824 Arm or wrist
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 6/42 Arrangements for detecting radiation specially adapted for radiation diagnosis
• CPC Class Codes: A61B 6/463 characterised by displaying multiple images or images and diagnostic data on one display
• CPC Class Codes: A61N 2005/1021 Radioactive fluid
• CPC Class Codes: A61N 5/1001 using radiation sources introduced into or applied onto the body; brachytherapy
• CPC Class Codes: A61N 5/1071 : for verifying the dose delivered by the treatment plan
• CPC Class Codes: A61N 5/1075 : for testing, calibrating, or quality assurance of the radiation treatment apparatus
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 50/50 : for simulation or modelling of medical disorders

Abstract

A device for measuring a plurality of parameters of a patient subject to a treatment with radiopharmaceuticals includes a main body constrained to the patient'"'"'s body in such a way that the measurement device is of wearable type. The device includes a plurality of measurement modules, for example a first module and a second module, each of which is equipped with a respective sensor, configured to measure a predetermined parameter of the patient. The device is also equipped with a microprocessor configured to process a plurality of data measured by the plurality of sensors, obtaining a plurality of processed data. Furthermore, a transmission means is provided of wireless type arranged to send via wireless communication the data processed by the microprocessor to a remote control unit.

Claims

1. A multiparametric device for measuring a plurality of parameters of a patient subject to a treatment with radiopharmaceuticals, said device comprising:

a main body constrained to the patient'"'"'s body, in such a way that said device for measuring, in use, is worn by the patient;

a plurality of measurement modules, each measurement module of said plurality equipped with a sensor configured to measure a predetermined parameter of said patient;

a microprocessor configured to process a plurality of data measured by each of said sensors of said plurality of measurement modules, obtaining a plurality of processed data;

a wireless transmission means arranged to send via wireless communication said data processed by said microprocessor to a remote control unit;

a supplier arranged to supply said microprocessor and each sensor of said plurality;

engagement means arranged to engage with respective engagement means of each measurement module of said plurality, said engagement means arranged to operatively connect said microprocessor with each sensor of said plurality;

wherein at least one measurement module of said plurality is a measurement module of radiations equipped with a radiation sensor configured to measure said radiations in a predetermined time range (Dt);

wherein said measurement module is configured to be arranged at a distance from the patient'"'"'s body in such a way that said radiation sensor is arranged to measure the radiations emitted by the source of radiations from a fixed distance; and

wherein said control unit is arranged to carry out a processing procedure of said processed data for determining the time of discharge (td) of said patient subject to said treatment with radiopharmaceuticals;

wherein said processing procedure comprises the steps of;

constructing a characteristic curve (g) representative of the number of radiations detected by said sensors of radiations in function of the time;

determining a time (t) at which said characteristic curve (g) assumes a value equal to, or lower than, a predetermined lower threshold value (t*), said time (t) corresponding to the time of discharge of the patient;

wherein said constructing step of said characteristic curve (g) provides the steps of;

counting the number of pulses emitted by said radiation sensor when said radiations are detected in a predetermined time range (Δ

t1) obtaining the number of pulses in said time range (n(Δ

t1));

identifying a point representative of said number of pulses (n(Δ

t1)) on a graph (n(Δ

t1)) versus time (t);

repeating said counting step and said identifying step for a predetermined number (k) of time range (Dt1) with a delay one from the subsequent one of a second predetermined time range (Dt₂) for an overall time of detection (Dt_tot), at the end of said repeating step being determined the number (k) of radioactive particles in a predetermined time range (ni(Dt₁)), with i=1 . . . k and identified a corresponding number (k) of points (Pi) on said graph;

constructing said characteristic curve (g) on said graph through said plurality of points (Pi), each point (Pi) of said plurality corresponding to a number of pulses (n_i(Dt₁)) counted at a i-th second time range (Dti₂);

determining said time of discharge (td) of the patient from said characteristic curve (g), through the steps of;

comparing said constructed characteristic curve (g) with a plurality of predetermined calibration curves;

selecting among said plurality of calibration curves a selected calibration curve (g*) which better approximates said constructed characteristic curve (g);

identifying on said selected calibration curve (g*) the time (t) at which said selected calibration curve (g*) assumes a value equal to, or lower than, said predetermined lower threshold value (n*(Dt₁)).

2. The device, according to claim 1, wherein said engagement means of each of said measurement module and said engagement means of said main body are arranged to provide a positive engagement, said engagement means being configured to recognize said module, to avoid that a module can be connected to said main body at a wrong connection port.

3. The device, according to claim 1, wherein, in addition to said measurement module for measuring the radiations emitted by the patient'"'"'s body, at least one measurement module is further provided selected from the group consisting of:

a measurement module configured to measure the arterial pressure;

a measurement module configured to measure the cardiac frequency;

a measurement module configured to measure SpO2;

a measurement module configured to measure the position;

a measurement module configured to measure the temperature;

a measurement module configured to measure ECG V4 derivations;

a measurement module configured to measure the frequency breath;

or a combination thereof.

4. The device, according to claim 1, wherein said remote control unit is arranged to carry out a digital filtering of said plurality of data transmitted via wireless communication from said microprocessor, said digital filtering arranged to reduce noises which are possible distortions owing to the wireless transmission of the signal associated with said plurality of data.

5. The device, according to claim 1, wherein said measurement module of the radiations is provided with a shielding element arranged to insulate said sensor of radiations from said wireless transmission means, in order to avoid interferences between the wireless transmission and the detection of radiations carried out by the radiation sensor.

6. The device, according to claim 4, wherein said shielding element is a thin plate of predetermined thickness made of a metal material.

7. The device, according to claim 5, wherein said metal material is aluminium.

8. The device, according to claim 1, wherein said radiation sensor is a solid state sensor, in such a way to allow to reduce its size and to ensure at the same time precise measurements of the energy associated with the radiations emitted by the patient'"'"'s body.

9. The device, according to claim 1, comprising:

a first measurement module of the radiations, said first module equipped with a first radiation sensor configured to measure a first plurality of radiation data at a first zone of analysis of the patient'"'"'s body;

at least a second measurement module of the radiations, said second measurement module equipped with a second radiation sensor configured to measure a second plurality of radiation data at a second zone of analysis of the patient'"'"'s body.

10. The device, according to claim 1, wherein said radiation sensor is arranged to emit an impulse, or “

spike”

, at each detection of radiations emitted by the patient and said microprocessor is arranged to count the number of pulses emitted by said radiation sensor in a predetermined time range (Dt₁) obtaining the number of pulses in said time range (n(Dt₁).

11. The device, according to claim 1, further comprising a display connected to each of said sensors, wherein said display is arranged to display said main parameters measured by each of said sensors.

12. The device, according to claim 1, wherein said plurality of measurement modules are measurement modules of radiations of different types, wherein each of said measurement modules of radiations of different types has a radiation sensor that is sensitive to a predetermined range of radiations that is different from that of other radiation sensors.