Stents, stenting systems, and related methods for agent delivery

• US 20050177226A1
• Filed: 02/22/2005
• Published: 08/11/2005
• Est. Priority Date: 12/21/2001
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Geitz, Kurt, Banik, Michael S.
• Granted Patent: US 8,062,348 B2
• Time in Patent Office: Days
• US Class Current: 623/1.420
• 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: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves

Abstract

A stenting system for insertion into the lumen of a body duct or vessel for delivering a therapeutic agent to a treatment site on the duct or vessel. The stenting system includes an a tubular stent member having a lumen there through to allow the passage of material, an outer membrane attached to the stent at least a portion of which is porous to the therapeutic agent to allow the agent to pass to the treatment site, an inner membrane attached to the stent which is nonporous to the therapeutic agent to prevent the agent from entering the lumen of the stent, and a chamber located between the inner and outer membranes for holding the therapeutic agent. The therapeutic agent in the chamber may diffuse through the porous portion of the membrane and be deposited directly on the body site.

Claims

1-30. -30. (canceled)

31. A system for insertion into a body lumen for delivering an agent to a site on the body lumen, the system comprising,

a tubular member having a lumen there through to allow the passage of material;

an outer membrane surrounding the tubular member, wherein at least a portion of the outer membrane is porous to the agent to allow the agent to be deposited on the site;

an inner membrane attached to the tubular member, wherein the inner membrane is non-porous to the therapeutic agent to be delivered to the site; and

a chamber located between the inner and outer membranes for holding the agent, wherein the agent in the chamber diffuses through the porous portion of the outer membrane and onto the body site.

32. The system according to claim 31, further comprising an opening in the chamber for delivery of the agent to the chamber.

33. The system according to claim 32, further comprising a one-way valve in the opening preventing the agent from exiting the chamber through the valve.

34. The system according to claim 31, wherein the inner membrane prevents the agent in the chamber from entering the lumen of the tubular member.

35. The system according to claim 31, wherein the tubular member is formed from a material that can return to its initially formed shaped after deformation.

36. The system according to claim 31, wherein the tubular member is capable of being expanded by a balloon inserted into the lumen of the tubular member.

37. The system according to claim 31, wherein the outer membrane is flexible such that it may conform to the shape of the body lumen.

38. The system according to claim 31, further including a tubing in communication with the chamber for introducing the agent into the chamber.

39. The system according to claim 31, further including grasping members located on the tubular member for grasping the tubular member.

40. A system for insertion into a body lumen for delivering an agent to a site on the body lumen, the system comprising,

a inner tubular member having a lumen there through for the passage of material;

a membrane surrounding the inner tubular member; and

a porous outer tubular member surrounding the inner tubular member and the membrane, wherein the membrane and the porous outer tubular member define a chamber therebetween for holding the agent, wherein the agent in the chamber may pass through the porous outer tubular member and be deposited directly on the body site, and wherein the membrane is non-porous to the agent thereby isolating the lumen of the inner tubular member from the agent in the chamber.

41. The system according to claim 40, further comprising balloons located at each end of the porous outer tubular member, wherein the balloons can be expanded to retain the system against a wall of the lumen.

42. The system according to claim 40, wherein the inner tubular member is capable of being expanded such that when it is expanded the system is retained against the lumen wall.

43. The system according to claim 42, wherein the inner tubular member is formed from a material that can return to its initially formed shape after deformation.

44. The system according to claim 42, wherein the inner tubular is capable of being expanded by a balloon inserted into the lumen of the inner tubular member.

45. The system according to claim 40, further including a tubing in communication with the chamber for introducing the agent into the chamber.

46. The system according to claim 40, further including grasping members located on the inner tubular member for grasping the inner tubular member.

47. The system according to claim 40, further comprising an opening in the chamber for delivery of the agent to the chamber.

48. The system according to claim 47, further comprising a one-way valve in the opening preventing the agent from exiting the chamber through the valve.

49. A system for delivering an agent to a body site comprising:

a tube having a lumen there through, wherein the sides of the tube have openings therein to allow passage of material through the lumen;

an outer membrane surrounding the tube and forming a chamber with a surface of the tube, wherein at least a portion of the membrane is porous to the agent allowing diffusion of the agent there through to the body site, and wherein the tube prevents the agent from diffusing from the chamber and into the lumen of the tube; and

an opening in the chamber allowing delivery of the agent to the chamber.

50. The system according to claim 49, further comprising an inner membrane attached to the tube, wherein the inner member is non-porous to the agent and prevents the agent in the chamber from entering the lumen.

51. The system according to claim 49, further comprising a one-way valve in the opening preventing the agent from exiting the chamber through the valve.

52. The system according to claim 49, wherein the tube is formed from a material that can return to its initially formed shape after deformation.

53. The system according to claim 49, wherein the tube is expanded against the body by a balloon catheter introduced through the lumen of the tube.

54. The system according to claim 49, further comprising tissue adhesives located along a portion of the tube for retaining the tube at the body site.

55. A system for delivering and retaining a system in a body lumen comprising:

a tubular member for supporting a target body lumen, the tubular member having first and second ends and a lumen there through;

tissue adhesives located along at least a portion of the length of the tubular member to adhere to the tissue and retain the tubular member in the body lumen; and

an outer tubular member to which the tissue adhesives will not adhere, wherein the outer tubular member surrounds the tubular member and tissue adhesives during delivery of the tubular member to the body lumen to prevent the tissue adhesives from adhering to body sites other than the target body lumen and the outer tubular member is removed once the tubular member reaches the target body lumen to allow the tissue adhesives to retain the tubular member in the body lumen.

56. The system according to claim 55, wherein the tissue adhesives are located on the first and second ends of the tubular member.

57. The system according to claim 55, further comprising an outer membrane surrounding the tubular member and forming a chamber with a surface of the tubular member, wherein at least a portion of the membrane is porous to an agent to be delivered to the body lumen allowing diffusion of the agent there through to the body lumen.

58. The system according to claim 57, wherein the tubular member prevents the agent from diffusing from the chamber and into the lumen of the tubular member.

59. The system according to claim 58, wherein the tubular member includes an inner membrane attached to the tubular member, and the inner membrane prevents the agent from diffusing from the chamber and into the lumen of the tubular member.

60. The system according to claim 57, further including an opening in the chamber allowing delivery of the agent to the chamber.