Regulation of drug delivery through flow diversion

• US 20020193751A1
• Filed: 04/02/2002
• Published: 12/19/2002
• Est. Priority Date: 10/12/1999
• Status: Abandoned Application

• Current Assignee: DURECT Corporation
• Original Assignee: DURECT Corporation
• Inventors: Nelson, Timothy Scott, Brown, James E., Theeuwes, Felix
• Application Number:
  US10/116,713
• Publication Number:
  US 20020193751A1
• Time in Patent Office: Days
• US Class Current: 604/248
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61M 39/28 Clamping means for squeezing flexible tubes, e.g. roller clamps tube strippers A61M1/83
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16804 Flow controllers
• CPC Class Codes: A61M 5/16813 by controlling the degree of opening of the flow line

Abstract

The present invention features methods and devices for modulating the rate of delivery of a drug formulation from a drug delivery device by diverting drug away from a drug delivery pathway. In one embodiment, a flow regulator is positioned relative to a drug delivery pathway of a drug delivery system so that adjustment of the flow regulator can provide for diversion of drug away from the drug delivery pathway. Diverted drug can be either delivered into the systemic circulation of the subject, or can be captured in a waste reservoir.

Claims

1. A method for delivering a desired amount of a drug to a treatment site of a subject, the method comprising:

causing a quantity of drug to exit from a drug reservoir of a drug delivery device in a direction toward a treatment site; and

diverting a portion of the quantity of drug exiting the drug delivery device away from the treatment site such that said diverted portion does not reach the treatment site;

wherein said diverting results in delivery of a desired amount of drug to the treatment site.

2. The method of claim 1, wherein the treatment site is a biologically confined treatment site and the diverted drug is diverted into a systemic site within the subject.

3. The method of claim 1, wherein the diverted drug is collected into a waste reservoir.

4. The method of claim 1, wherein the desired amount of drug is delivered to the treatment site by varying the amount of drug delivered to the treatment site relative to the amount of drug diverted from the drug delivery device.

5. The method of claim 1, wherein said diverting is by intermittent disruption of flow of drug exiting the drug delivery device.

37. A method of administering drug to a treatment site in a subject, the method comprising:

implanting at least the distal end of the flow regulator delivery conduit of the flow regulator of claim 1 at a treatment site within a subject; and

delivering drug from a drug delivery device, through the drug delivery pathway of the flow regulator, and to the treatment site;

wherein the drug is administered to the treatment site in the subject.

42. A method of controlling an amount of drug administered to a treatment site in a subject, the method comprising:

introducing a drug into the flow regulator proximal delivery inlet of the drug delivery system of claim 1, said introducing resulting in drug flowing through the drug delivery pathway and to a treatment site in a subject at which a distal end of the drug delivery conduit is implanted; and

adjusting the diversion element of the flow regulator to divert drug from the drug delivery pathway;

wherein said adjusting alters the amount of drug that is delivered to the treatment site in the subject.

43. The method of claim 42, wherein the drug delivery device is a constant rate drug delivery device.

44. The method of claim 42, where drug diverted from the drug delivery pathway is delivered to the subject systemically.

45. The method of claim 42, wherein the flow regulator comprises a waste reservoir for receiving drug diverted from the delivery pathway.

46. The method of claim 42, wherein the distal end of the drug delivery conduit is attached to a drug delivery catheter to provide for extension of the drug delivery pathway to a catheter delivery outlet at the catheter distal end, wherein at least the catheter distal end is implanted at the treatment site.

47. The method of claim 46, wherein the catheter is adapted for delivery of drug to two treatment sites.

48. The method of claim 42, wherein the treatment site is subcutaneous, percutaneous, intravenous, intrathecal, intramuscular, intra-arterial, intravascular, intraperitoneal, intraspinal, epidural, intracranial, intracardial, peritumoral, or intratumoral.

49. The method of claim 42, wherein the treatment site is a site within a kidney, liver, pancreas, heart, lung, eye, ear, lymph node, breast, prostate, ovary, testicle, thyroid, spleen, central nervous system, skeletal muscle, bone, lymph vessel, artery, arteriole, capillary bed, blood vessel, vein, peripheral nervous system, digestive system, gastrointestinal tract, urinary bladder, gall bladder, adrenal gland, adipose tissue, parathyroid gland, uterus, fallopian tube, skin, tumorous growth, autologous graft, synthetic graft, or site of microbial infection.

50. The method of claim 42, wherein the diversion element is adjusted for a first time period so as to facilitate flow through the delivery conduit, and for a second time period so as to decrease flow through the diversion conduit, wherein varying the length of the first and second time periods results in alteration in the amount of drug delivery to the treatment site.

51. The method of claim 42, wherein the flow regulator further comprises:

a diversion conduit comprising a diversion inlet, a diversion outlet, and a diversion lumen extending between the diversion inlet and diversion outlet, the diversion conduit lumen defining a diversion pathway;

wherein drug diverted by the diversion element flows into the diversion pathway defined by the diversion conduit.

52. The method of claim 51, wherein the diversion element is adjusted so that the delivery conduit and the diversion conduit are each partially open.

6. A flow regulator (10) for regulating the flow of a drug from a drug delivery device (110) to a treatment site in the body of a subject, the flow regulator comprising:

a proximal delivery inlet (21), wherein the proximal delivery inlet is proximal to and communicably attached to the drug delivery device;

a distal delivery outlet (22), wherein the distal delivery outlet is distal to the drug delivery device;

a delivery conduit (20) extending between the proximal delivery inlet and the distal delivery outlet, the delivery lumen defining a delivery pathway (60); and

a diversion element (40) positioned so as to facilitate diversion of flow of the drug in a direction away from the distal delivery outlet.

7. The flow regulator of claim 6, wherein the diversion element (40) is manually adjustable.

8. The flow regulator of claim 6, wherein the diversion element (40) is remotely adjustable.

9. The flow regulator of claim 8, wherein the diversion element (40) is adjustable by use of a remote actuation device.

10. The flow regulator of claim 6, wherein the diversion element (40) is a valve.

11. The flow regulator of claim 10, wherein the valve is a compression valve for compressing against a deformable wall of the delivery conduit (20) at a site distal to a proximal drug exit outlet (25).

12. The flow regulator of claim 10, wherein the valve is a rotatable valve (42).

13. The flow regulator of claim 10, wherein the valve is a solenoid (47).

14. The flow regulator of claim 6, wherein the flow regulator further comprises:

a diversion conduit (30) comprising a diversion inlet (31), a diversion outlet (32), and a diversion lumen extending between the diversion inlet and diversion outlet, the diversion conduit lumen defining a diversion pathway (70);

wherein drug diverted by the diversion element (40) flows into the diversion pathway defined by the diversion conduit.

15. The flow regulator of claim 14, wherein the delivery conduit (20) and the diversion conduit (30) intersect in a substantially T-shaped configuration.

16. The flow regulator of claim 14, wherein the delivery conduit (20) and the diversion conduit (30) intersect in a substantially Y-shaped configuration.

17. The flow regulator of claim 14, wherein the delivery conduit (20) and the diversion conduit (30) intersect in a substantially U-shaped configuration.

18. The flow regulator of claim 14, wherein the diversion conduit (20) is in fluid communication with a waste reservoir (90) for receiving drug from the diversion outlet (32).

19. The flow regulator of claim 18, wherein the waste reservoir comprises (90) a self-sealing septum.

20. The flow regulator of claim 6, wherein the delivery conduit (20) comprises an attachment element (130) for attaching a drug delivery (110) device for delivery of drug into the proximal delivery inlet (21).

21. The flow regulator of claim 6, wherein the delivery conduit (20) comprises a valve at a delivery conduit distal end.

22. The flow regulator of claim 6, wherein the flow regulator (10) is contained within a housing element (45).

23. The flow regulator of claim 14, wherein the housing element (45) comprises a biocompatible, implantable material.

24. The flow regulator of claim 6, wherein the flow regulator (10) is attached to a drug delivery catheter (120) at a delivery conduit distal end to provide for flow of drug from the delivery pathway (60), out the distal delivery outlet (22), and into a lumen of the drug delivery catheter.

25. The flow regulator of claim 9, wherein the remote actuation device comprises power source for actuation of the diversion element.

26. The flow regulator of claim 9, wherein the flow regulator is programmable by the remote actuation device.

27. A drug delivery system (100) comprising;

the flow regulator (10) of claim 6; and

a drug delivery device (110);

wherein the drug delivery device is attached to the flow regulator to facilitate delivery of a drug from the drug delivery device, through the delivery conduit (20) lumen, and out the distal delivery outlet (22).

28. The drug delivery system of claim 27, wherein the flow regulator is detachably attached to the drug delivery device (110).

29. The drug delivery system of claim 27, wherein the drug delivery device (110) is a convective drug delivery device.

30. The drug delivery system of claim 27, wherein the drug delivery device (110) is a diffusive drug delivery device.

31. The drug delivery system of claim 27, wherein the flow regulator further (110) comprises:

a diversion conduit (30) comprising a diversion inlet (31), a diversion outlet (32), and a diversion lumen extending between the diversion inlet and diversion outlet, the diversion conduit lumen defining a diversion pathway (70);

wherein drug diverted by the diversion element (40) flows into the diversion pathway defined by the diversion conduit.

32. The drug delivery system of claim 27, wherein the drug delivery device (110) is implantable.

33. The drug delivery system of claim 27, wherein the system further comprises a remote actuation device for actuation of the diversion element (40).

34. A drug delivery catheter (120) comprising a catheter body defining a proximal opening, a distal opening, and a catheter lumen extending between the proximal and distal openings, the catheter further comprising a flow regulator (10) according to claim 6, wherein the catheter lumen and the flow regulator delivery lumen are in fluid communication.

35. The drug delivery catheter of claim 34, wherein the flow regulator delivery conduit (20) is continuous and integral to the catheter body.

36. The drug delivery catheter of claim 34, wherein the flow regulator (10) is positioned at a proximal portion of the catheter.

38. The method of claim 37, wherein the delivery conduit lumen is suitable for delivery of the drug at a low volume rate.

39. The method of claim 37, wherein the flow regulator drug delivery conduit provides for delivery of drug to at least two treatment sites.

40. The method of claim 37, wherein the treatment site is subcutaneous, percutaneous, intravenous, intramuscular, intra-arterial, intravascular, intraperitoneal, intraspinal, epidural, intrathecal, intracranial, intracardial, peritumoral, or intratumoral.

41. The method of claim 37, wherein the treatment site is a site within a kidney, liver, pancreas, heart, lung, eye, ear, lymph node, breast, prostate, ovary, testicle, thyroid, spleen, central nervous system, skeletal muscle, bone, lymph vessel, artery, arteriole, capillary bed, blood vessel, vein, peripheral nervous system, digestive system, gastrointestinal tract, urinary bladder, gall bladder, adrenal gland, adipose tissue, parathyroid gland, uterus, fallopian tube, skin, tumorous growth, autologous graft, synthetic graft, or site of microbial infection.

53. The flow regulator of claim 6, wherein at least the distal delivery outlet (22) is adapted for implantation at the treatment site.

54. The flow regulator of claim 53, wherein the diversion element (40) is adapted for implantation.

55. The flow regulator of claim 6, wherein the diversion element (40) is provided to divert drug away from the distal delivery outlet (22) and to a systemic site within the subject.