INJECTION DEVICES WITH TISSUE SWELLING DETECTION

• US 20170266370A1
• Filed: 09/11/2015
• Published: 09/21/2017
• Est. Priority Date: 09/15/2014
• Status: Abandoned Application

• Current Assignee: Sanofi
• Original Assignee: Sanofi
• Inventors: Cerman, Zdenek
• Application Number:
  US15/509,464
• Publication Number:
  US 20170266370A1
• Time in Patent Office: Days
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1586 Holding accessories for holding infusion needles on the body
• 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 2205/18 with alarm
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• CPC Class Codes: A61M 5/14248 of the skin patch type
• 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 5/16836 by sensing tissue properties at the infusion site, e.g. for detecting infiltration detecting tissue temperature for diagnostic purposes A61M39/0247
• CPC Class Codes: A61M 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates

Abstract

An injection device comprising a housing; a securing arrangement for securing the injection device against an injection site of a patient; a needle insertion mechanism configured to cause insertion of a needle into a patient when the injection device is secured against the injection site of the patient; a medicament delivery arrangement configured to cause injection of a medicament into tissue of the patient at the injection site; and a medicament retention sensor configured to detect retention of medicament in the tissue of the patient at the injection site, wherein the injection device is configured to respond to detection of swelling of the tissue of the patient at the injection site by causing provision of an alert and/or by causing suspension or halting of injection of medicament.

Claims

1. An injection device comprising:

a housing;

a securing mechanism configured to secure the injection device against an injection site of a patient;

a needle insertion mechanism configured to cause insertion of a needle into a patient when the injection device is secured against the injection site of the patient;

a medicament delivery mechanism configured to cause injection of a medicament into tissue of the patient at the injection site; and

a medicament retention sensor configured to detect retention of medicament in the tissue of the patient at the injection site,

wherein the injection device is configured to respond to detection by the medicament retention sensor of medicament in the tissue of the patient at the injection site by at least one of causing provision of an alert and suspending or halting the injection of the medicament.

2. A device as claimed in claim 1, wherein the injection device is configured to respond to the detection of medicament in the tissue of the patient at the injection site by causing provision of an alert without suspending or halting injection of medicament.

3. A device as claimed in claim 1, wherein the injection device is configured to respond to the detection of medicament in the tissue of the patient at the injection site by suspending or halting injection of the medicament and causing provision of an alert.

4. A device as claimed in claim 1, wherein the injection device comprises an alerting transducer and wherein the injection device is configured to respond to the detection of retention of medicament in the tissue of the patient at the injection site by causing the alerting transducer to provide an alert.

5. A device as claimed in claim 1, wherein the injection device is configured to respond to the detection of medicament in the tissue of the patient at the injection site by causing suspension or halting of injection of medicament without causing provision of an alert.

6. A device as claimed in claim 1, wherein the securing mechanism comprises an adhesive provided on an exterior surface of the housing.

7. A device as claimed in claim 1, wherein the medicament retention sensor comprises at least two electrical contacts configured to contact the skin of the patient adjacent the injection site and the medicament retention sensor is configured to detect retention of medicament in the tissue of the patient at the injection site by detecting a change in an electrical property of an external path between the at least two electrical contacts.

8. A device as claimed in claim 7, wherein the medicament retention sensor comprises a camera configured to include in a field of view of the camera an area of the patient'"'"'s skin around the injection site when the injection device is secured against the injection site of the patient.

9. A device as claimed in claim 8, wherein the medicament retention sensor is configured to monitor features of the patient'"'"'s skin and determine when features are moving relatively apart from one another and thereby detect retention of the medicament.

10. A device as claimed in claim 1, wherein the securing mechanism comprises a belt or strap configured to extend around a limb of the patient and compress the housing against the injection site of the patient.

11. A device as claimed in claim 10, wherein the medicament retention sensor is configured to detect a force in or extension of the strap or belt.

12. A device as claimed in claim 11, wherein the medicament retention sensor is configured to monitor measures of force in or extension of the strap or belt compared to a measure obtained at an earlier time.

13. A device as claimed in claim 11, wherein the medicament retention sensor is configured to eliminate or compensate for movements of the user.

14. A device as claimed in claim 1, wherein the device is a bolus injector device.

15. A device as claimed in claim 1, with a container of medicament.

16. The drug delivery device of claim 15, wherein the medicament comprises a pharmaceutically active compound.

17. A method comprising:

securing an injection device against an injection site of a patient, the injection device comprising a medicament retention sensor, a needle insertion mechanism, and medicament delivery mechanism;

causing the needle insertion mechanism to insert a needle into a patient when the injection device is secured against the injection site of the patient; and

causing the medicament delivery mechanism to inject a medicament into tissue of the patient at the injection site, the medicament retention sensor detecting retention of medicament in the tissue of the patient at the injection site and responding to a detection by causing one or more of;

provisioning an alert, suspending the injection of the medicament, and halting the injection of the medicament.