Integrated injection system and communication device

• US 10,292,641 B2
• Filed: 07/10/2013
• Issued: 05/21/2019
• Est. Priority Date: 07/10/2012
• Status: Active Grant

• Current Assignee: Becton Dickinson France (Becton, Dickinson & Co)
• Original Assignee: Becton Dickinson France (Becton, Dickinson & Co)
• Inventors: Bureau, Christophe, Hausser, Roderick, Monchoix, Herve
• Primary Examiner(s): Lee, Erica S
• Application Number:
  US14/413,536
• Publication Number:
  US 20150201880A1
• Time in Patent Office: 2,141 Days
• Field of Search: None
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0462 Apparatus with built-in sensors
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• 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 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02055 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 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/4866 Evaluating metabolism A61B5/083 takes precedence
• CPC Class Codes: A61B 5/4872 Body fat
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6898 Portable consumer electronic devices, e.g. music players, telephones, tablet computers
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: A61M 2005/1588 having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
• CPC Class Codes: A61M 2005/1726 : the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2037/0023 : Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0061 : Methods for using microneedles
• CPC Class Codes: A61M 2205/0294 : Piezoelectric materials
• CPC Class Codes: A61M 2205/3576 : with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2230/00 : Measuring parameters of the user
• CPC Class Codes: A61M 37/0015 : by using microneedles
• CPC Class Codes: A61M 5/142 : Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/158 : Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/20 : Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54

Abstract

An integrated system for injection including an injection device (10) in electronic connection with a communication device (A) is provided. The external communication device may be a handheld electronic device such as a Smartphone or a dedicated reader such as a reader capable of reading information contained on an RFID tag. The injection device includes a needle (12) and a drug delivery portion (28) enclosed within an external housing. Optionally, a plurality of sensors (16) is affixed to the surface of the needle to collect data about the injection and physical characteristics of the patient. The data may be recorded on a data capture module (36). The electronic chip may be a readable and writable electronic chip such as a nonvolatile memory chip. The injection device may further include a data transmitter (42) for sending information obtained from the data capture module to the external communications device.

Claims

1. An integrated injection system, the system comprising:

an injection device comprising a drug delivery portion comprising a reservoir containing a pharmaceutical agent, the injection device further comprising a data transmitter, a data capture module including at least one sensor, and a receiver device, wherein the injection device is configured to deliver the pharmaceutical agent to a body of a patient,

wherein the data capture module is configured to sense information about a physical condition and/or a behavior of a patient during an injection event,

wherein the data transmitter is configured to be in electronic communication with a communication device that is external to the injection device, and

wherein the receiver device is configured to be placed on an area of the body of the patient during the injection event,

wherein the injection device is configured to send an electrical signal with a predefined waveform through a needle into the body of the patient, and wherein the receiver device is configured to identify and process the predefined waveform to determine if the waveform of the signal measured by the receiver device is substantially similar to a reference injection signal waveform associated with the pharmaceutical agent being successfully injected into the body of the patient to determine if the pharmaceutical agent was successfully injected into the body of the patient, and

wherein the data transmitter is configured to transmit at least a portion of the sensed information about the physical condition and/or the behavior of the patient sensed during the injection and a confirmation that the pharmaceutical agent has been successfully injected into the body of the patient to the communication device.

2. The integrated injection system of claim 1, wherein the drug delivery portion comprises a needle, and wherein the at least one sensor is located on a portion of the needle which is intended to be positioned inside the body of the patient during the injection event.

3. The integrated injection system of claim 2, wherein the at least one sensor is positioned within the body of the patient during the injection event.

4. The integrated injection system of claim 2, wherein the injection device further comprises an external housing enclosing the drug delivery portion and the data transmitter, and wherein the needle is in fluid communication with the reservoir and extendable through at least a portion of the external housing.

5. The integrated injection system of claim 4, wherein the data transmitter is configured to transmit a signal to the communication device when the pharmaceutical agent has been fully expelled from the reservoir.

6. The integrated injection system of claim 5, wherein the communication device is configured to provide an indication which alerts a user that the pharmaceutical agent has been expelled from the reservoir in response to the signal.

7. The integrated injection system of claim 1, wherein the drug delivery portion includes an activator configured to engage a drive mechanism configured to expel the pharmaceutical agent from the injection device, and wherein the activator is configured to be triggered by an activation activity performed by a user on the communication device.

8. The integrated injection system of claim 1, wherein the at least one sensor is configured to measure a physical characteristic of the patient.

9. The integrated injection system of claim 8, wherein the physical characteristic is metabolism, body temperature, heart rate, blood pressure, or body fat composition.

10. The integrated injection system of claim 1, wherein the communication device is configured to analyze at least a portion of the sensed information to determine adherence to a prescribed treatment routine.

11. The integrated injection system of claim 1, wherein the communication device is configured to analyze the sensed information in correlation with data obtained from other sources to determine adherence to a prescribed treatment routine.

12. The integrated injection system of claim 1, wherein at least one of the injection device and the communication device is configured to store the sensed information from a plurality of different injection events.

13. The integrated injection system of claim 1, wherein the injection device further comprises an electronic chip configured to store the sensed information.

14. The integrated injection system of claim 13, wherein the electronic chip is further configured to store information identifying at least one of a type of injection device, an injection time of the injection event, or an injection location of the injection event.

15. The integrated injection system of claim 14, wherein the electronic chip is configured to store additional information pertaining to a manufacturing or a distribution process of the injection device.

16. The integrated injection system of claim 1, wherein the data transmitter comprises a wireless transmitter such that the electronic communication with the communication device is performed wirelessly.

17. The integrated injection system of claim 1, wherein the data transmitter comprises a wired connection including a pin connector configured for insertion into a corresponding port of the communication device such that the electronic communication with the communication device is performed over the wired connection.

18. The integrated injection system of claim 1, wherein the injection device further comprises an internal power source.

19. The integrated injection system of claim 1, wherein the injection device is configured to receive power from the communication device.

20. The integrated injection system of claim 1, wherein the communication device is configured to transmit at least a portion of the sensed information to at least one external system.

21. The integrated injection system of claim 1, wherein the communication device comprises a user interface display configured to provide at least a portion of the sensed information to a user.

22. The integrated injection system of claim 1, wherein the communication device is a smart phone.

23. An integrated injection system, the system comprising:

an injection device comprising a drug delivery portion comprising a reservoir containing a pharmaceutical agent, the injection device further comprising a data transmitter, and a receiver device, wherein the injection device is configured to deliver the pharmaceutical agent to a body of a patient,

wherein the data transmitter is configured to be in electronic communication with a communication device that is external to the injection device, and

wherein the receiver device is configured to be placed on an area of the body of the patient during the injection event,

wherein the injection device is configured to send an electrical signal with a predefined waveform through a needle into the body of the patient, and wherein the receiver device is configured to identify and process the predefined waveform to determine if the waveform of the signal measured by the receiver device is substantially similar to a reference injection signal waveform associated with the pharmaceutical agent being successfully injected into the body of the patient to determine if the pharmaceutical agent was successfully injected into the body of the patient, and

wherein the data transmitter is configured to transmit a confirmation that the pharmaceutical agent has been successfully injected into the body of the patient to the communication device.

24. A method for monitoring an injection event, the method comprising:

delivering, by an injection device, a pharmaceutical agent to the body of a patient;

sending, by the injection device through a needle, an electrical signal with a predefined waveform into the body of the patient;

sensing, by at least one sensor of a data capture module of the injection device, information about a physical condition and/or a behavior of the patient during the injection event;

identifying and processing, with a receiver device placed on an area of the body of the patient during the injection event, the predefined waveform to determine if the waveform of the signal measured by the receiver device is substantially similar to a reference injection signal waveform associated with the pharmaceutical agent being successfully injected into the body of the patient to determine if the pharmaceutical agent was injected into the body of the patient;

establishing, by a data transmitter of the injection device, an electronic communication with a communication device that is external to the injection device; and

transmitting, by the data transmitter of the injection device, at least a portion of the sensed information about the physical condition and/or the behavior of the patient sensed during the injection and a confirmation that the pharmaceutical agent has been at least partially expelled from the reservoir and successfully injected into the body of the patient to the communication device.

25. A method for monitoring an injection event, the method comprising:

delivering, by an injection device, a pharmaceutical agent to the body of a patient;

sending, by the injection device through a needle, an electrical signal with a predefined waveform into the body of the patient;

identifying and processing, with a receiver device placed on an area of the body of the patient during the injection event, the predefined waveform to determine if the waveform of the signal measured by the receiver device is substantially similar to a reference injection signal waveform associated with the pharmaceutical agent being successfully injected into the body of the patient to determine if the pharmaceutical agent was successfully injected into the body of the patient;

establishing, by a data transmitter of the injection device, an electronic communication with a communication device that is external to the injection device; and

transmitting, by the data transmitter of the injection device, a confirmation that the pharmaceutical agent has been at least partially expelled from the reservoir and successfully injected into the body of the patient to the communication device.