Drug Delivery Devices, Systems, and Methods

• US 20110112508A1
• Filed: 10/01/2010
• Published: 05/12/2011
• Est. Priority Date: 11/09/2009
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Panzirer, David
• Granted Patent: US 9,199,034 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

This disclosure relates to drug delivery devices, systems, and methods. In some aspects, a drug delivery device includes an elongate member defining a fluid passage and an opening in fluid communication with the fluid passage, and a projection extending radially from the elongate member. A portion of the elongate member extending axially from the projection to a distal end of the elongate member has a length sufficient to allow the distal end of the elongate member to reach subdermal tissue of a patient when the elongate member is inserted into the patient and the projection is in contact with an outer surface of skin of the patient, and the opening is positioned at a location along the elongate member such that the opening is disposed within a dermis of the patient when the elongate member is inserted into the patient and the projection is in contact with the outer surface of the skin of the patient.

Claims

1. A drug delivery device, comprising:

an elongate member defining a fluid passage and an opening in fluid communication with the fluid passage; and

a projection extending radially from the elongate member,

wherein a portion of the elongate member extending axially from the projection to a distal end of the elongate member has a length sufficient to allow the distal end of the elongate member to reach subdermal tissue of a patient when the elongate member is inserted into the patient and the projection is in contact with an outer surface of skin of the patient, and the opening is positioned at a location along the elongate member such that the opening is disposed within a dermis of the patient when the elongate member is inserted into the patient and the projection is in contact with the outer surface of the skin of the patient.

2. The drug delivery device of claim 1, wherein the portion of the elongate member extending axially from the projection to a distal end of the elongate member has a length of at least about four millimeters, and the opening is positioned at a location that is axially spaced from the projection by no more than about 2.5 millimeters.

3. The drug delivery device of claim 2, wherein the portion of the elongate member extending axially from the projection to the distal end of the elongate member has a length of at least about five millimeters.

4. The drug delivery device of claim 1, wherein the portion of the elongate member extending axially from the projection to the distal end of the elongate member has a length of about four millimeters to about nine millimeters.

5. The drug delivery device of claim 1, wherein the opening is positioned at a location that is axially spaced from the projection by about 0.3 millimeter to about 2.5 millimeters.

6. The drug delivery device of claim 1, wherein a portion of the elongate member between the opening and the distal end of the elongate member comprises a self-sealing material.

7. The drug delivery device of claim 6, wherein the self-sealing material comprises a polymeric material.

8. The drug delivery device of claim 6, wherein the self-sealing material is capable of forming a substantially liquid-tight seal after a needle having a diameter smaller than a diameter of the passage is inserted through the self-sealing material and then removed.

9. The drug delivery device of claim 1, wherein a portion of the elongate member between the opening and the distal end of the elongate comprises a valve.

10. The drug delivery device of claim 9, wherein the valve is capable of forming a substantially liquid-tight seal after a needle having a diameter smaller than a diameter of the passage is inserted through the valve and then removed.

11. The drug delivery device of claim 1, further comprising at least one feature extending radially from a portion of the elongate member between the opening and the distal end of the elongate member.

12. The drug delivery device of claim 11, wherein the feature is a barb.

13. The drug delivery device of claim 1, wherein the passage terminates proximal to the distal end of the elongate member.

14. The drug delivery device of claim 13, wherein the passage terminates at the opening.

15. The drug delivery device of claim 1, wherein the elongate member has a sharp distal tip.

16. The drug delivery device of claim 15, wherein the sharp distal tip is not in fluid communication with the passage.

17. The drug delivery device of claim 1, wherein the elongate member defines a plurality of openings in fluid communication with the passage, and the plurality of openings are positioned at locations along the elongate member such that the openings are disposed within the dermis of the patient when the elongate member is inserted into the patient and the projection is in contact with the outer surface of the skin of the patient.

18. The drug delivery device of claim 17, wherein the plurality of openings are circumferentially spaced around the elongate member.

19. The drug delivery device of claim 17, wherein the plurality of openings are axially spared along the elongate member.

20. A drug delivery system, comprising:

an elongate member defining a fluid passage and an opening in fluid communication with the fluid passage;

a projection extending radially from the elongate member; and

a needle configured to extend through the passage and distally beyond a distal end of the elongate member,

wherein a portion of the elongate member extending axially from the projection to a distal end of the elongate member has a length sufficient to allow the distal end of the elongate member to reach subdermal tissue of a patient when the needle and the elongate member are inserted into the patient and the projection is in contact with an outer surface of skin of the patient, and the opening is positioned at a location along the elongate member such that the opening is disposed within a dermis of the patient when the elongate member and the needle are inserted into the patient and the projection is in contact with the outer surface of the skin of the patient.

21. The drug delivery system of claim 20, wherein the portion of the elongate member extending axially from the projection to a distal end of the elongate member has a length of at least about four millimeters, and the opening is positioned at a location that is axially spaced from the projection by no more than about 2.5 millimeters.

22. The drug delivery system of claim 21, wherein the portion of the elongate member extending axially from the projection to the distal end of the elongate member has a length of at least about five millimeters.

23. The drug delivery system of claim 20, wherein the portion of the elongate ember extending axially from the projection to the distal end of the elongate member has a length of about four millimeters to about nine millimeters.

24. The drug delivery system of claim 20, wherein the opening is positioned at a location that is axially spaced from the projection by about 0.3 millimeter to about 2.5 millimeters.

25. The drug delivery system of claim 20, wherein a portion of the elongate member between the opening and the distal end of the elongate member comprises a self-sealing material.

26. The drug delivery system of claim 25, wherein the self-sealing material is capable of forming a substantially liquid-tight seal after the needle is inserted through the self-sealing material and then removed.

27. The drug delivery system of claim 20, wherein a portion of the elongate member between the opening and the distal end of the elongate comprises a valve.

28. The drug delivery system of claim 27, wherein the valve is capable of forming a substantially liquid-tight seal after the needle is inserted through the valve and then removed.

29. The drug delivery system of claim 20, further comprising at least one feature extending radially from a portion of the elongate member between the opening and the distal end of the elongate member.

30. The drug delivery system of claim 20, wherein the passage terminates proximal to the distal end of the elongate member.

31. The drug delivery system of claim 30, wherein the passage terminates at the opening.

32. The drug delivery system of claim 20, wherein the elongate member defines a plurality of openings in fluid communication with the passage, and the plurality of openings are positioned at locations along the elongate member such that the openings are disposed within the dermis of the patient when the elongate member is inserted into the patient and the projection is in contact with the outer surface of the skin of the patient.

33. The drug delivery system of claim 20, further comprising a drug injection device capable of being placed in fluid communication with the passage of the elongate member.

34. The drug delivery system of claim 33, wherein the drug injection device comprises a pump.

35. The drug delivery system of claim 33, further comprising a tube connected to the drug injection device and to the elongate member.

36. A drug delivery method, comprising:

inserting an elongate member into a patient such that a distal end of the elongate member is positioned in subdermal tissue of the patient; and

delivering a drug to a dermis of the patient via the elongate member.

37. The drug delivery method of claim 36, wherein the elongate member defines a passage and an opening in fluid communication with the passage, and delivering the drug to the dermis of the patient comprises delivering the drug through the passage and then out the opening into the dermis.

38. The drug delivery method of claim 37, wherein the distal end of the elongate member is closed such the drug is prevented from exiting the distal end of the elongate member into the subdermal tissue.

39. The drug delivery method of claim 36, wherein the elongate member is mounted on a needle when the elongate member is inserted into the patient.

40. The drug delivery method of claim 39, further comprising removing the needle from the elongate member prior to delivering the drug.