Method and device for drug delivery

• US 9,220,837 B2
• Filed: 06/21/2007
• Issued: 12/29/2015
• Est. Priority Date: 03/19/2007
• Status: Active Grant

• Current Assignee: InsuLine Medical Ltd.
• Original Assignee: InsuLine Medical Ltd.
• Inventors: Pesach, Benny, Nagar, Ron, Bitton, Gabriel, Weiss, Ram
• Primary Examiner(s): Berdichevsky, Aarti B
• Assistant Examiner(s): Engel, Matthew A
• Application Number:
  US11/821,230
• Publication Number:
  US 20080281297A1
• Time in Patent Office: 3,113 Days
• Field of Search: 604 65- 67, 604/113, 604/175, 604/180, 604/890.1
• US Class Current: 1/1
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• 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: A61B 18/20 using laser
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61F 7/007 characterised by electric heating
• 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 2039/1022 additionally providing electrical connection
• 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 2205/8206 battery-operated
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• 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: 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 5/422 : Desensitising skin
• 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 2005/0645 : Applicators worn by the patient
• 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

A method and a device for a delivery of a chemical substance to the body of the patient are provided. The device includes an infusion catheter configured to be inserted into a 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 system for delivery of a therapeutic first substance from a reservoir of a drug delivery pump to a body of a patient, comprising;

a drug delivery pump comprising a reservoir to contain the therapeutic first substance;

an infusion catheter configured to be inserted subcutaneously into a tissue of the patient at an insertion site, wherein a volume of tissue surrounding the insertion site comprises an infused region;

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

a tubing configured to transport the therapeutic first substance between the reservoir of the drug delivery pump and the infusion catheter; and

a treatment element comprising a heater included with the catheter securing element and affixed thereto and configured to apply a treatment to a vicinity of the infused region to modify a pharmacodynamics profile of the therapeutic first substance,

wherein

the drug delivery pump is configured to infuse the therapeutic first substance into the infusion catheter for delivery to the infused region, and

the heater is configured to heat the infused region without heating the reservoir and without heating any of the therapeutic first substance and the tubing above a predetermined limiting temperature above which degrades the therapeutic first substance prior to infusion of the therapeutic first substance into the infused region or prior to the therapeutic first substance being infused into the infusion catheter.

2. A system for delivery of a therapeutic first substance to a body of a patient, comprising:

a drug delivery pump comprising a reservoir to contain the therapeutic first substance;

an infusion set configured for use with and connection to the drug delivery pump, wherein the drug delivery pump provides a flow of the therapeutic first substance to the body of the patient, comprising;

an infusion catheter configured to be inserted subcutaneously into a tissue of the patient at an insertion site, wherein a volume of tissue surrounding the insertion site comprises an infused region;

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

a tubing configured to transport the therapeutic first substance between the drug delivery pump and the infusion catheter;

a treatment element comprising a heater and included with the catheter securing element and affixed thereto, and configured to apply a treatment to a vicinity of the infused region to modify a pharmacodynamic profile of the therapeutic first substance, and

at least one wire provided along the tubing configured to supply at least one of power and control to the treatment element from a power source and/or a controller located adjacent or near the drug delivery pump and apart from the treatment element;

wherein

the drug delivery pump is configured to infuse the therapeutic first substance into the infusion catheter for delivery to the infused region, the heater is configured to heat the infused region without heating the reservoir and without heating any of the therapeutic first substance and the tubing above a predetermined limiting temperature above which degrades the therapeutic first substance prior to infusion of the therapeutic first substance into the infused region or prior to the therapeutic first substance being infused into the infusion catheter.

3. The system according to claim 2, wherein the treatment element power is regulated to produce a predetermined stable temperature at the infused region.

4. The system according to claim 3, treatment element is configured to be embedded into the catheter securing element, wherein the catheter securing element is configured to be connected to the drug delivery pump using the at least one wire and tubing.

5. The system according to claim 4, further comprising a connector housing configured to connect said at least one wire and tubing.

6. The system according to claim 5, wherein the connector housing is adjacent to the treatment element.

7. The system according to claim 5, wherein the connector housing is adjacent to the drug delivery pump.

8. The system according to claim 5, further comprising a cap configured to seal the connector housing when the connector housing is disconnected.

9. The system according to claim 3, further comprising a temperature sensor provided in the treatment element and wherein the at least one wire connects the temperature sensor to the drug delivery pump.

10. The system according to claim 2, wherein the treatment element is configured to apply a second treatment, wherein the second treatment comprises an energy source;

and wherein the treatment is energy.

11. The system according to claim 10, wherein the energy is selected from a group consisting of:

radiation, mechanical vibrations, suction, magnetic energy, ultrasound, light irradiation, RF irradiation, microwave, and electrical.

12. The system according to claim 11, wherein the drug delivery pump and the treatment element are configured to communicate with one another to determine when to apply the treatment and/or the second treatment.

13. The system according to claim 12, wherein communication between the drug delivery pump and the treatment element is wireless.

14. The system according to claim 10, wherein the drug delivery pump and the treatment element are configured to be combined in a single device.

15. The system according to claim 10, wherein the drug delivery pump includes a sensor for determining when to apply the therapeutic first substance.

16. The system according to claim 2, wherein the therapeutic first substance is insulin, insulin analogues or insulin mimetics.

17. The system according to claim 16, wherein the treatment is applied during and/or after an infusion of an insulin bolus dose.

18. The system according to claim 17, further comprising a processing unit configured to initiate the treatment element to apply the treatment upon detection of the insulin bolus.

19. The system according to claim 16, wherein the treatment is applied before, during and/or after an infusion of an insulin bolus dose.

20. The system according to claim 16, wherein the treatment element provides heat subsequent to an infusion of an insulin bolus dose for a period of between about 10 minutes and about 30 minutes.

21. The system according to claim 14, wherein the treatment element provides heat subsequent to an infusion of an insulin bolus dose for a period of between about 1 minutes and about 10 minutes.

22. The system according to claim 2, further comprising a processing unit for controlling at least the treatment element and optionally the drug delivery pump for delivering the therapeutic first substance to the infusion catheter.

23. The system according to claim 22, wherein the processing unit is disposed in the drug delivery pump.

24. The system according to claim 22, wherein the processing unit is disposed in an enclosure adjacent to the drug delivery pump.

25. The system according to claim 22, wherein the processing unit is disposed in an enclosure attached to the drug delivery pump.

26. The system according to claim 2, wherein the treatment element is configured to regulate heating of the infused region to stabilize a temperature of the therapeutic first substance infused in the tissue region at approximately the predetermined limiting temperature.

27. The system according to claim 26, wherein the predetermined limiting temperature is between about 37 degrees C. and about 42 degrees C.

28. The system according to claim 26, wherein the predetermined limiting temperature is between about 37 degrees C. and about 39 degrees C.

29. The system according to claim 26, wherein the predetermined limiting temperature is between about 32 degrees C. and about 37 degrees C.

30. The system according to claim 2, further comprising a temperature sensor configured to indicate a temperature of the therapeutic first substance prior to infusion into the infused region.

31. The system according to claim 30, further comprising a processing unit configured to verify that the therapeutic first substance is not heated above the predetermined limiting temperature prior to the therapeutic first substance being infused into the infused region.

32. The system according to claim 2, wherein the catheter securing element and treatment element are disposed in the same housing.

33. The system according to claim 32, wherein the catheter securing element is combined with treatment element in the same disposable housing.

34. The system according to claim 2, further comprising an activator for manual activation of said treatment element.

35. The system according to claim 34, wherein said communication channel comprises wireless communication.

36. The system according to claim 2, wherein the pharmacodynamic profile is modified either before, during and/or after a period of delivery of the therapeutic first substance to the patient.

37. The system according to claim 2, wherein the treatment element is further configured to modify absorption of the therapeutic first substance into at least one of the blood system and the lymphatic system of the patient during and/or following a period of delivery of the therapeutic first substance to the patient.

38. The system according to claim 2, wherein the tissue comprises a blood vessel.

39. The system according to claim 2, wherein the pharmacodynamic profile of the therapeutic first substance is modified to enable a faster onset of action of the therapeutic first substance infused into the infused region.

40. The system according to claim 2, wherein the treatment element includes a processing unit and wherein the drug delivery pump and the reservoir to contain the therapeutic first substance are provided in the same housing.

41. The system according to claim 2, wherein the heater is attached to skin around the insertion site.

42. The system according to claim 2, wherein the heater is attached to skin around the catheter securing element.

43. The system according to claim 2, wherein the heater is U shaped.

44. The system according to claim 2, wherein the heater does not heat the therapeutic first substance prior to the therapeutic first substance being infused into an end of the infusion catheter or prior to being infused into the infused region.

45. The system according to claim 2, further comprising thermal insulation disposed between the treatment element and the reservoir and wherein the thermal insulation is configured to prevent heating of the therapeutic first substance above the predetermined limiting temperature.

46. The system according to claim 2, wherein the predetermined limiting temperature is about 37 degrees C.

47. The system according to claim 2, wherein the treatment element is provided between the catheter securing element and the skin of the patient.

48. The system according to claim 2, wherein the treatment element comprises an intra catheter electrical heater.

49. The system according to claim 2, wherein the treatment element is configured to heat the infused region using optical radiation.

50. The system according to claim 2, further comprising a temperature sensor provided adjacent to the skin of the patient and proximal to the insertion site of the infusion catheter.

51. The system according to claim 2, further comprising a temperature sensor embedded into the infusion catheter and further configured to be proximal to the infused region.

52. The system according to claim 2, wherein heat is produced at a power of between about 0.25 watts and about 2 watts.

53. The system according to claim 2, wherein the treatment element operates between on and off states to produce a predetermined stable temperature at the infused region.

54. The system according to claim 2, wherein the catheter securing element is disposable and the treatment element is disposable.

55. The system according to claim 2, wherein the treatment element is configured to apply one or more additional substances to the infused region wherein a second substance modifies the pharmacodynamic profile of the therapeutic first substance.

56. The system according to claim 2, wherein the treatment element is configured to apply one or more additional substances to the infused region wherein a second substance modifies absorption of the therapeutic first substance into a blood system and/or lymphatic system of the patient and/or promotes clearance of therapeutic first substance from the infused region.

57. The system according to claim 2, further comprising a processing unit for controlling administration of the therapeutic first substance;

and a communication channel for communication between said treatment element and the processing unit.

58. The system according to claim 2, wherein the system is configured to modify a bolus dose effect of the therapeutic first substance on the body of the patient.

59. The system according to claim 2, wherein the device further comprises a housing configured to include:

the power source,

the controller,

at least one electrical contact,

at least one indicator configured to indicate;

whether the treatment is applied, whether the power source has adequate power, whether a problem occurred with the treatment, and/or whether the at least one electrical contact is disconnected,

at least one activation switch configured to activate at least one component of the device, and

another reservoir configured to contain a second substance.

60. The system according to claim 2, wherein the treatment element is configured to be combined with the catheter securing element and/or the drug delivery pump.