Device and method for drug delivery

• US 8,961,458 B2
• Filed: 11/06/2009
• Issued: 02/24/2015
• Est. Priority Date: 11/07/2008
• Status: Active Grant

• Current Assignee: InsuLine Medical Ltd.
• Original Assignee: InsuLine Medical Ltd.
• Inventors: Pesach, Benny, Bitton, Gabriel, Nagar, Ron, Weiss, Ram
• Primary Examiner(s): Berdichevsky, Aarti B
• Assistant Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US13/127,823
• Publication Number:
  US 20110288527A1
• Time in Patent Office: 1,936 Days
• Field of Search: 604/113, 604/22, 604/20, 604/66
• US Class Current: 604/113
• 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, comprising:

a treatment element having a plurality of injection sites for administering at least one injection of a drug into a tissue, wherein each injection site in the plurality of injection sites corresponds to a predetermined location on the tissue for injection of the drug at a specific time;

a processor provided within the treatment element;

a heating element provided within or adjacent to the treatment element, the heating element being controlled by and electrically coupled to the processor and configured to apply heat to the tissue at the predetermined location during at least one of before, during and after injection of the drug for a predetermined period of time such that the tissue is heated to a predetermined temperature which is less than a predetermined limiting temperature; and

a temperature sensor electrically coupled to the processor and configured to provide a signal corresponding to the temperature of the tissue heated by the treatment element,

wherein;

based on the temperature of the tissue, the processor is configured to stabilize heating of the tissue to the predetermined temperature,

application of heat by the heating element is configured to improve pharmacokinetic and/or pharmacodynamic properties of the drug, and

the treatment element includes a disposable part and a reusable part, and

the disposable part includes at least one identification element configured to determine whether the disposable part has been used.

2. The device according to claim 1, wherein the reusable part includes

the processor;

an energy source coupled to the processor and configured to provide energy to the device for applying heat at least once; and

the temperature sensor.

3. The device according to claim 2, wherein the temperature sensor is configured to be in temperature communication with at least one of the following:

the heated tissue surrounding the predetermined location and the heating element.

4. The device according to claim 1, wherein the at least one identification element include at least one of the following:

an electrically-burnable element, serial number such as EPROM chip, an RFID chip, an optical barcode, and a mechanical attachment that can be used only once.

5. The device according claim 1, wherein the treatment element includes at least one injection site marker configured to indicate at least one injection site in the plurality of injection sites.

6. The device according to claim 1, wherein the treatment element includes an identification mechanism configured to identify a time when the drug is injected;

wherein, based on information provided by the identification mechanism, the heating element is configured to automatically apply the heat.

7. The device according to claim 1, wherein the treatment element includes an identification mechanism configured to identify the predetermined injection location on the tissue;

wherein, based on information provided by the identification mechanism, the heating element is configured to apply a predetermined heat profile.

8. The device according to claim 7, wherein the predetermined injection location corresponds to at least one meal type or at least one drug dose.

9. The device according to claim 1, wherein the treatment element includes an indicator configured to indicate that a specific injection site was used.

10. The device of according to claim 1, wherein the heating element is configured to be disposed in at least one of the following ways:

adjacent to the predetermined location on the tissue, partially surrounding the predetermined location on the tissue, and completely surrounding the predetermined location on the tissue.

11. The device according to claim 1, wherein the treatment element includes a sensor configured to

detect injection of the drug into the tissue;

and,

based on the detection, generate a signal to the processor to activate the heating element.

12. The device according to claim 6, wherein the identification mechanism includes at least one of the following:

a sensor configured to sense folding of a skin, a pressure sensor disposed on the heating element, a pressure sensor disposed on a marker 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 drug into the tissue.

13. The device according to claim 12, wherein the device for injecting drug into the tissue includes at least one of the following:

a syringe and an injector pen.

14. The device according to claim 1, wherein the injected drug is insulin.

15. The device according to claim 1, wherein the treatment device includes at least one predetermined treatment profile dependent on a dosage and a type of the drug being injected.

16. The device according to claim 15, wherein the treatment device includes a mechanism configured to measure a volume of the injected drug stored in a tissue depot and further configured to adjust application of the heat based on the measured volume.

17. The device according to claim 16, wherein the measurement of the volume is performed using an electrical impedance measurement.

18. The device according to claim 1, wherein the treatment device includes a mechanism configured to generate an alert corresponding to a time of a next injection.

19. A method for administering a drug into a tissue comprising:

providing a treatment device comprising;

a treatment element having a plurality of injection sites for administering at least one injection of a drug into a tissue, wherein each injection site in the plurality of injection sites corresponds to a predetermined location on the tissue for injection of the drug at a specific time;

a processor provided within the treatment element;

a heating element provided within or adjacent to the treatment element, the heating element being controlled by and electrically coupled to the processor and configured to apply heat to the tissue at the predetermined location during at least one of before, during and after injection of the drug for a predetermined period of time such that the tissue is heated to a predetermined temperature which is less than a predetermined limiting temperature;

a temperature sensor electrically coupled to the processor and configured to provide a signal corresponding to the temperature of the tissue heated by the treatment element;

the treatment element includes a disposable part and a reusable part, and

the disposable part includes at least one identification element configured to determine whether the disposable part has been used;

placing the treatment element in temperature communicative contact with tissue at the predetermined location;

administering the drug to the tissue at the predetermined location using a first injection site;

applying the heat to the tissue at the predetermined location;

determining a temperature of the tissue at the predetermined location; and

controlling, based on the determined temperature, the heating of the tissue at the predetermined location to prevent heating the injected drug above the predetermined limiting temperature.

20. The method according to claim 19, wherein the applying further comprises

determining a time when the drug is injected into the tissue;

and

applying, based on the determining, the heat.

21. The method according to claim 19, wherein the applying further comprises

determining the predetermined location on the tissue;

and

applying, based on the determining, the heat.

22. The method of according to claim 19, wherein the applying further comprises

applying the heat in at least one of the following ways:

adjacent to the predetermined location on the tissue, partially surrounding the predetermined location on the tissue, and completely surrounding the predetermined location on the tissue.

23. The method according to claim 19, wherein the administering further comprises

administering the drug using a device for injecting the drug into the tissue;

wherein the device for injecting the drug includes at least one of the following;

a syringe and an injector pen.

24. The method according to claim 19, wherein the administered drug is insulin.