Intravascular delivery system for therapeutic agents

• US 20050234431A1
• Filed: 02/10/2005
• Published: 10/20/2005
• Est. Priority Date: 02/10/2004
• Status: Abandoned Application

• Current Assignee: Synecor LLC
• Original Assignee: Synecor LLC
• Inventors: Holbrook, Kevin, Williams, Michael S., Ransbury, Terrance
• Application Number:
  US11/055,540
• Publication Number:
  US 20050234431A1
• Time in Patent Office: Days
• US Class Current: 604/890.100
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: A61M 5/14236 Screw, impeller or centrifugal type pumps
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

Described herein is a system for intravascular drug delivery system, which includes a reservoir implantable a blood vessel, an intravascular pump fluidly coupled to the reservoir and an anchor expandable into contact with a wall of the blood vessel to retain the system within the vasculature. Delivery conduits may be extend from the reservoir and are positionable at select locations within the vasculature for target drug delivery to select organs or tissues.

Claims

1. A system for intravascular drug delivery, the system comprising:

a reservoir proportioned for implantation within a blood vessel;

a flexible elongate device body proportioned for implantation within the blood vessel;

an anchor coupled to the device body and expandable into contact with a wall of the blood vessel;

a pump housed within the device body and fluidly coupled to the reservoir, the pump operable to direct agent from the reservoir into the bloodstream.

2. The system according to claim 1, wherein the reservoir is housed within the device body.

3. The system according to claim 2, wherein the reservoir comprises an inflatable bladder disposed within the device body.

4. The system according to claim 1, wherein the reservoir is external to the device body.

5. The system according to claim 4, wherein the reservoir comprises an elongate inflatable bladder extending longitudinally from the device body.

6. The system according to claim 1, wherein the pump includes a motor and an energy source electrically coupled to the motor.

7. The system according to claim 5, wherein the energy source includes a battery.

8. The system according to claim 1, wherein the reservoir extends longitudinally from the device body.

9. The system according to claim 1, wherein the device body includes at least one flexible region, the region sufficiently flexible to permit bending of the device body during movement of the device through a blood vessel.

10. The system of claim 9, wherein the device body includes a plurality of housing segments, and flexible regions interconnecting adjacent housing segments.

11. The system of claim 10, wherein the pump is sealed within one of the housing segments, and wherein the system further includes a motor and a battery each sealed within housing segments.

12. The system of claim 10, wherein the reservoir is positioned within a plurality of the housing segments.

14. The system of claim 1, wherein the device body is formed of titanium.

15. The system of claim 1, wherein the device body has a length of approximately 10 cm or greater.

16. The system of claim 1, wherein the device body has a cross-sectional area of approximately 79 mm² or less.

17. The system of claim 16, wherein the pulse generator has a cross-sectional area of approximately 40 mm² or less.

18. The system of claim 1, wherein the pump is selected from the group of pumps consisting of gear pumps, peristaltic pumps, solenoid pumps, vacuum pumps, venturi pumps, double-acting membrane pumps, metering pumps, syringe pumps and vaporization displacement pumps.

19. The system according to claim 1, wherein the reservoir contains microspheres containing an agent.

20. The system of claim 1, further including telemetry circuitry within the device housing and a remote communication device operable from outside the body to communicate with the telemetry circuitry.

21. The system according to claim 1, further including at least one elongate conduit extending from the device body, wherein the pump is operable to direct agent through the conduit into the bloodstream.

22. The system according to claim 21, further including an anchor expandable to anchor the elongate conduit within a blood vessel.

23. The system according to claim 21, wherein the device body is positionable in a first blood vessel and the conduit is positionable in a second, different, blood vessel.

24. The system according to claim 1, wherein the system includes a fill conduit extending from the reservoir, a fill port coupled to the fill conduit, and an extracorporeal reservoir connectable to the fill conduit.

25. The system according to claim 24, wherein the fill port is positionable within a blood vessel.

26. The system according to claim 24, wherein the fill port is positionable within a subcutaneous pocket.

27. The system according to claim 24, wherein the extracorporeal reservoir comprises a syringe.

28. The system according to claim 24, wherein the syringe includes a needle engageable with the fill port.

29. The system according to claim 1, wherein:

the reservoir includes a mixing chamber, a first chamber containing a first substance, and a second chamber containing a second substance;

the pump is a dispensing pump positioned to pump agent from the mixing chamber into the bloodstream;

the system further includes a first pump for pumping the first substance from the first chamber into the mixing chamber;

the system further includes a second pump for pumping the second substance from the second chamber into the mixing chamber.

30. The system according to claim 29, wherein the first substance is a liquid and the second substance is a powder.

31. The system according to claim 30, wherein the second pump is a metering pump.

32. The system according to claim 30, wherein the first chamber is an inflatable bladder.

33. The system according to claim 32, wherein the inflatable bladder is positioned external to the device body, and wherein the second chamber is positioned within the device body.

34. The system according to claim 1, further including:

a controller within the device body, wherein the pump is controlled by the controller to pump agent into the bloodstream.

35. The system according to claim 34, wherein the controller is programmed to cause agent delivery according to a predetermined dosing schedule.

36. The system according to claim 34, further including a sensor on the device body for detecting a condition within the patient'"'"'s body, wherein the controller is responsive to a condition detected by the sensor to cause agent to be pumped into the bloodstream.

37. The system according to claim 36, wherein the controller is responsive to a degree of the condition detected by the sensor to determine a dosage of agent to be pumped into the bloodstream.

38. The system according to claim 34, wherein the controller includes telemetry circuitry and the system includes a remote communication device operable from outside the body to communicate with the telemetry circuitry, wherein the controller is responsive to signals received by the telemetry circuitry to cause agent to be pumped into the bloodstream according to a specified dosing schedule.

68. The method according to claim 1, wherein the reservoir contains radioactive particles.

13. The system of claim 13, wherein the reservoir includes a plurality of bladders, each positioned in a corresponding one of the housing segments.

39. A method for delivering an agent into the bloodstream, comprising the steps of:

providing an intravascular drug delivery system comprising an elongate flexible device body and a reservoir;

percutaneously introducing the delivery system into a blood vessel and advancing the delivery system within the blood vessel, causing the device body to flex during movement through the blood vessel;

anchoring the delivery system within the blood vessel;

delivering an agent into the reservoir; and

releasing agent from the reservoir into the bloodstream.

40. The method of claim 39, wherein the delivering step is carried out prior to the introducing step.

41. The method of claim 39, wherein the delivering step is carried out after the introducing step.

42. The method of claim 39, wherein the delivering step causes the reservoir to inflate.

43. The method of claim 39, wherein the device body includes a plurality of housing segments, and flexible regions interconnecting adjacent housing segments, and wherein the step of causing the device body to flex includes causing bending at the flexible regions.

44. The method of claim 39, wherein the releasing step includes driving agent into the bloodstream using a pump.

45. The method of claim 39, wherein:

the providing step provides the system to include an elongate conduit extending from the device body; and

the method includes positioning the conduit within a blood vessel; and

the releasing step includes releasing agent through the conduit into the bloodstream.

46. The method of claim 45, wherein the anchoring step includes anchoring the delivery system with the device body in a first blood vessel and positioning at least a portion of the conduit in a second blood vessel different from the first blood vessel.

47. The method of claim 46, wherein the second blood vessel is a hepatic artery.

48. The method of claim 46, wherein the second blood vessel is a renal artery.

49. The method of claim 46, wherein the second blood vessel is a subclavian artery.

50. The method of claim 39, wherein:

the device body and reservoir include a mixing chamber, a first chamber containing a first substance, and a second chamber containing a second substance; and

the method includes the steps of directing a quantity of first substance from the first chamber into the mixing chamber, and directing a quantity of second substance from the second chamber into the mixing chamber to form the agent; and

the releasing step includes releasing the agent from the mixing chamber.

51. The method according to claim 50, wherein the first substance is a liquid and the second substance is a powder.

52. The method according to claim 50, wherein the step of directing a quantity of second substance into the mixing chamber includes the step of activating a metering pump disposed in the second chamber.

53. The method according to claim 50, wherein the first chamber is an inflatable bladder.

54. The method according to claim 39, wherein the step of delivering the agent includes delivering microspheres containing the agent.

55. The method according to claim 54, wherein releasing step includes releasing the microspheres from the reservoir.

56. The method according to claim 55, wherein the method further includes causing the microspheres to embolize within a vessel and allowing agent to elute from the microspheres into the bloodstream.

57. The method according to claim 39, wherein the system includes a pump and a controller within the device body and wherein in the releasing step the controller causes the pump to pump agent into the bloodstream according to a dosing schedule.

58. The method according to claim 57, further including the step of programming the dosing schedule into the controller prior to the introducing step.

59. The method according to claim 57, further including the step of programming the dosing schedule into the controller after the introducing step.

60. The method according to claim 59, wherein the introducing step includes the step of attaching a delivery mandrel to the device body and pushing the mandrel the position the device body within the blood vessel, and wherein the programming step includes the step of electronically coupling the delivery mandrel to a programming device positioned outside the body and transmitting the dosing schedule to the controller using the programming device.

61. The method according to claim 59, wherein the controller includes telemetry circuitry and the system further includes a remote communication device operable from outside the body to communicate with the telemetry circuitry, and wherein the programming step includes transmitting the dosing schedule to the controller using the remote communication device.

62. The method according to claim 57, wherein the system includes a sensor on the device body, wherein the method includes the step of detecting a parameter within the body using the sensor, and wherein in the releasing step the controller is responsive to a parameter detected by the sensor to cause agent to be pumped into the bloodstream.

63. The method according to claim 62, wherein the detecting step determines a degree of the detected parameter, and wherein in the releasing step the controller is responsive to the detected degree to determine a dosing schedule and to cause the agent to be pumped according to the determined dosing schedule.

64. The method according to claim 62, wherein the sensor detects a physical or chemical parameter.

65. The method according to claim 64, wherein the sensor detects a parameter from the group of parameters consisting of arterial pressure, cardiac output, heart rate, Q-T interval, AVO₂ difference, blood pH, blood gas levels, blood sugar, and biochemical markers.

66. The method according to claim 47, wherein the step of delivering the agent includes delivering microspheres containing the agent and wherein the releasing step includes releasing the microspheres from the reservoir, and wherein the method further includes causing the microspheres to embolize within a vessel and allowing agent to elute from the microspheres into the bloodstream.

67. The method according to claim 66, wherein the microspheres include a chemotherapeutic agent.