Method and device for drug delivery

• US 8,622,991 B2
• Filed: 03/19/2008
• Issued: 01/07/2014
• Est. Priority Date: 03/19/2007
• Status: Active Grant

• Current Assignee: InsuLine Medical Ltd.
• Original Assignee: InsuLine Medical Ltd.
• Inventors: Pesach, Benny, Bitton, Gabriel, Weiss, Ram, Nagar, Ron
• Primary Examiner(s): Schmidt, Emily
• Assistant Examiner(s): Thomas, Jr., Bradley G
• Application Number:
  US12/450,246
• Publication Number:
  US 20100152644A1
• Time in Patent Office: 2,120 Days
• Field of Search: 604/65, 604/67, 604/31, 604/508, 604/513, 604/113, 604/174, 604/180, 604/131, 604/151, 604/500
• US Class Current: 604/508
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61F 7/10 Cooling bags, e.g. ice-bags
• CPC Class Codes: A61H 23/00 Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms apparatus for passive exercising A61H1/00; generating or transmitting mechanical vibrations in general B06B
• CPC Class Codes: A61H 9/0057 Suction suction kneading A61H7/008
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/05 combined with other kinds of therapy
• CPC Class Codes: A61M 2205/051 with radiation therapy
• CPC Class Codes: A61M 2205/052 infrared
• CPC Class Codes: A61M 2205/058 with ultrasound therapy
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• 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 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• 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: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/406 using implantable thermoseeds or injected particles for localized hyperthermia preparations of seeds and particles A61K41/0052
• CPC Class Codes: A61N 2/002 : in combination with another treatment
• CPC Class Codes: A61N 2005/0645 : Applicators worn by the patient
• CPC Class Codes: A61N 5/062 : Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61N 7/00 : Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

Systems, devices and methods for delivery of a chemical substance to the body of the patient are provided. Such embodiments may include an infusion catheter configured to be inserted into tissue, a catheter securing element configured to be adhered to the skin of the patient and further configured to secure the infusion catheter to the skin, a drug delivery pump configured to infuse a drug into the infusion catheter for delivery to a drug infused region on the body of the patient, and a treatment element configured to apply a treatment to the drug infused region to improve pharmacodynamics of the drug during a period of delivery of the drug to the patient.

Claims

1. A device for delivering a therapeutic substance into the body of a patient, comprising:

an infusion catheter configured to be inserted into a bodily tissue disposed at an insertion site located on the body of the patient and further configured to deliver the therapeutic substance into the body of the patient to an infused region, wherein the infused region includes a volume of the bodily tissue surrounding the insertion site;

a catheter securing element configured to be adhered to the skin of the patient and further configured to secure the infusion catheter to the skin of the patient;

a housing including

a substance delivery device for infusing the therapeutic substance into the infusion catheter for delivery of the therapeutic substance into the infused region;

a sensor built into the housing and configured to detect infusion of the therapeutic substance;

a treatment element configured to apply a treatment in a vicinity of the infused region to modify a pharmacokinetic and/or pharmacodynamic profile of the therapeutic substance; and

a controller unit in communication with the treatment element and configured to initiate application of the treatment by the treatment element upon detecting beginning of the infusion of the therapeutic substance.

2. The device according to claim 1, wherein the treatment is applied at a time selected from a group consisting of:

before the therapeutic substance is delivered to the body of the patient, during delivery of the therapeutic substance to the body of the patient, and after the therapeutic substance has been delivered to the body of the patient.

3. The device according to claim 1, wherein the substance delivery device is a delivery pump.

4. The device according to claim 1, wherein the treatment element is configured to apply treatment in order to perform at least one of the functions selected from a group consisting of:

enabling a faster onset of action of the therapeutic substance infused into the infused region, enabling a faster peak of action of the therapeutic substance infused into the infused region, enabling a faster clearance of the therapeutic substance from the infused region and into a circulatory system of the patient, improving the repeatability of the pharmacokinetic and/or pharmacodynamic profile in response to the infusion of the therapeutic substance, reducing a variability of absorption of the therapeutic substance into the blood system and/or lymphatic system of the patent, reducing a variability of onset of action of the therapeutic substance, reducing a variability of time to peak of action of the therapeutic substance, and reducing a variability of the clearance of the therapeutic substance from the infused region and into the circulatory system of the patient.

5. The device according to claim 1, wherein the substance is configured to be injected subcutaneously and further configured to have a systemic effect.

6. The device according to claim 3, wherein the therapeutic substance is selected from a group consisting of:

insulin, insulin analogues, and insulin mimetics.

7. The device according to claim 1, wherein the treatment element is further configured to modify blood perfusion in the vicinity of the infused region.

8. The device according to claim 6, wherein the treatment element is a heater configured to modify a temperature of the bodily tissue in the vicinity of the infused region;

wherein the heater does not heat the therapeutic substance above a limiting temperature.

9. The device according to claim 6, wherein the treatment element is configured to heat the skin of the patient in the vicinity of the infused region to a temperature in a range of 37-39°

C. for a predetermined period of time after bolus infusion initiation.

10. The device according to claim 9, wherein the insulin is a rapid acting insulin.

11. The device according to claim 10, wherein insulin is infused into the patient using long period bolus mode, such as square or split bolus mode, to adjust the insulin pharmacokinetics and/or pharmacodynamics.

12. The device according to claim 10, wherein insulin is infused into the patient using fast bolus mode.

13. The device according to claim 9, wherein insulin is a regular insulin.

14. The device according to claim 6, wherein the sensor is configured to detect an infusion of an insulin bolus.

15. The device according to claim 14, wherein the sensor includes an electromagnetic sensing element for measuring an electromagnetic emission of the delivery pump.

16. The device according to claim 3, wherein the controller unit is disposed inside the delivery pump.

17. The device according to claim 8, wherein the housing further includes a reservoir containing the therapeutic substance and an infusion tube, and is configured to enclose the treatment element along with the substance delivery device and the reservoir;

wherein the treatment element is configured to apply heat in the vicinity of the infused region without heating the reservoir and the infusion tube above the limiting temperature.

18. The device according to claim 1, wherein the substance delivery device is disposable.

19. The device according to claim 1, wherein the treatment element is disposed in the catheter securing element.

20. The device according to claim 1, wherein the treatment element includes a heater and is configured to regulate heating of the infused region to stabilize its temperature at a pre-determined temperature in order to stabilize pharmacokinetics of the infused therapeutic substance.

21. The device according to claim 1, wherein the applied treatment is selected from a group consisting of:

heating, cooling, intermittent temperature change, optical radiation, micro-wave, radio frequency, electromagnetic radiation, vibration device, physical stimulation, massage the infused region, suction, vacuum, electric field, magnetic field, acoustic signal, ultrasound, and application of one more additional substances to modify the infused substance pharmacokinetics, and/or a combination of at least two of the above treatments.

22. A method for delivering a therapeutic substance into the body of a patient, the method comprising the steps of:

providing a device for delivering the therapeutic substance into the body of the patient having

an infusion catheter;

a catheter securing element;

a housing including

a substance delivery device;

a sensor built into the housing and configured to detect infusion of the therapeutic substance;

a treatment element; and

a controller unit in communication with the treatment element;

adhering the catheter securing element to the skin of the patient and securing the infusion catheter to the skin of the patient;

inserting the infusion catheter into a bodily tissue disposed at an insertion site located on the body of the patient;

using the substance delivery device, infusing the therapeutic substance into the infusion catheter;

using the infusion catheter, delivering the therapeutic substance into the body of the patient to an infused region, wherein the infused region includes a volume of the bodily tissue surrounding the insertion site;

using the controller unit, initiating application of the treatment by the treatment element upon detecting beginning of the infusion of the therapeutic substance;

using the treatment element, applying the treatment in a vicinity of the infused region; and

modifying a pharmacokinetic and/or pharmacodynamic profile of the infused therapeutic substance.