Device and method for drug delivery

• US 9,731,084 B2
• Filed: 01/29/2015
• Issued: 08/15/2017
• Est. Priority Date: 11/07/2008
• Status: Active Grant

• Current Assignee: InsuLine Medical Ltd.
• Original Assignee: InsuLine Medical Ltd.
• Inventors: Weiss, Ram, Nagar, Ron, Bitton, Gabriel, Pesach, Benny
• Primary Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US14/608,528
• Publication Number:
  US 20150265780A1
• Time in Patent Office: 929 Days
• CPC Class Codes: A61B 2018/00005 Cooling or heating of the probe or tissue immediately surrounding the probe
• CPC Class Codes: A61B 2090/0803 Counting the number of times an instrument is used
• CPC Class Codes: A61F 2007/0093 programmed
• CPC Class Codes: A61F 2007/0096 with a thermometer
• CPC Class Codes: A61F 2007/0226 adhesive, self-sticking
• CPC Class Codes: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61F 7/02 Compresses or poultices for effecting heating or cooling
• CPC Class Codes: A61M 2205/273 preventing reuse, e.g. of disposables
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3653 by Joule effect, i.e. electric resistance
• CPC Class Codes: A61M 2209/00 Ancillary equipment
• CPC Class Codes: A61M 5/003 Kits for diabetics
• 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
• 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
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media

Abstract

A therapeutic treatment device, system and method for improving administration of a temperature sensitive drug into a tissue on the body of a patient at a drug injection site are disclosed. The device includes a treatment element with a controllable heating element in temperature communicative contact with the tissue adjacent to the drug injection site. The controllable heating element is configured to heat the tissue adjacent to the drug injection site to a controllable temperature but does not heat the injected drug above a predetermined limiting temperature, above which degradation of the injected drug may occur.

Claims

1. A treatment device for effecting the adsorption of drug in tissue comprising:

a processor; and

a treatment element comprising a disposable part, a reusable part, at least one identification element configured to determine prior use of the disposable part, and an injection area for administering a plurality of injections of a drug into an injection site of a tissue at a location on the body,

wherein the treatment element is

controlled by the processor,

configured to apply a treatment to the tissue at or adjacent the injection site during at least one of before, during and after injection of the drug for a predetermined period of time, and

the treatment is configured to improve the pharmacokinetic and/or pharmacodynamic properties of the injected drug.

2. The device according to claim 1, wherein the treatment element includes a heating element controlled by the processor and the treatment comprises heat, and the tissue is heated to a predetermined temperature which is less than a predetermined limiting temperature above which the drug degrades.

3. The device according to claim 2, further comprising a temperature sensor configured to provide one or more signals corresponding to the temperature of the tissue at or adjacent the injection site, wherein based on the temperature of the tissue, the processor controls the heater to stabilize heating of the tissue to the predetermined temperature.

4. The device according to claim 1, wherein the reusable part includes the processor and an energy source for at least providing power to the treatment element, and wherein power from the energy source to the treatment element is controlled by the processor.

5. The device according to claim 1, further comprising a temperature sensor provided by the reusable part, wherein the sensor is configured to provide one or more signals corresponding to the temperature of the tissue at or adjacent the injection site to the processor.

6. The device according to claim 1, wherein the at least one identification element includes at least one of an electrically-burnable element, an EPROM chip, an RFID chip, a barcode, and a single-use mechanical attachment.

7. The device according claim 1, wherein the treatment element includes at least one marker indicating the location of the injection site.

8. The device according to claim 1, wherein the treatment element includes an identification mechanism configured to identify a time when the drug is injected, and wherein based on information provided by the identification mechanism, the treatment element is configured to automatically apply the treatment.

9. The device according to claim 8, wherein the identification mechanism comprises at least one of:

a skin sensor configured to sense folding of skin, a pressure sensor disposed on the treatment element, a pressure sensor disposed on a marker arranged on the treatment element and configured to mark a spot for placement of a finger during injection, and a proximity sensor configured to sense proximity of a device for injecting the drug into the tissue.

10. The device according to claim 1, wherein the processor is configured to control the treatment element to apply treatment according to a predetermined treatment profile.

11. The device according to claim 10, wherein the predetermined treatment profile corresponds to at least one meal type or at least one drug dose.

12. The device of according to claim 1, wherein the treatment element is configured for positioning adjacent the location.

13. The device according to claim 1, wherein the treatment element includes a detection sensor configured to detect injection of the drug into the tissue and provide one or more signals of such detection to the processor for effecting activation of the treatment element.

14. The device according to claim 1, further comprising a memory having stored thereon at least one predetermined treatment profile dependent on a dosage and a type of the drug being injected access by the processor for controlling the treatment element according to the profile.

15. The device according to claim 14, wherein the treatment device includes a measurement mechanism configured to provide one or more signals deterministic of a volume of the drug stored in the tissue at the location to the processor, and wherein the processor is further configured to adjust application of the treatment based on one or more signals.

16. The device according to claim 15, wherein the measurement mechanism comprises an impedance sensor configured to measure the impedance of the tissue at the location.

17. The device according to claim 1, wherein the treatment device further comprises an alert mechanism configured to provide an alert corresponding to a time of a next injection.