Balloon catheter lumen based stent delivery systems

• US 20040193179A1
• Filed: 12/24/2003
• Published: 09/30/2004
• Est. Priority Date: 03/26/2003
• Status: Abandoned Application

• Current Assignee: Biosensors International Group, Ltd.
• Original Assignee: CardioMind, Inc. (Biosensors International Group, Ltd.)
• Inventors: Nikolchev, Julian
• Application Number:
  US10/746,455
• Publication Number:
  US 20040193179A1
• Time in Patent Office: Days
• US Class Current: 606/108
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12063 electrolytically detachable
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires

Abstract

The invention provides an atraumatic, low profile device for the delivery of one or more implants into tubular organs or open regions of the body. The implant delivery device may simultaneously or independently release portions of the implant, e.g., the proximal and distal ends of the implant. This independent release feature allows better implant positioning at the target site. Upon deployment, the implants may be placed at the target site without a sheath.

Claims

1-21. -21. (Cancelled)

24. A implant delivery system comprising:

an elongate delivery guide member having a proximal end and a distal end, the delivery guide member configured to direct at least one implant having an exterior and interior surface to an anatomical treatment site by manipulation by a user,

the at least one implant having a delivery diameter prior to release of the at least one implant and located proximally of the distal end of the delivery guide member prior to release,

at least one releasable joint configured to maintain at least a section of the at least one implant at the delivery diameter until release of the at least one releasable joint, and

a balloon catheter having a lumen, the delivery guide member being positioned within the lumen.

22. The system of claim 24 wherein the implant exterior surface is smooth after deployment.

23. The device system of claim 24 wherein the implant interior surface is smooth after deployment.

25. The system of claim 24 wherein the delivery guide member is closed at its distal end.

26. The system of claim 24 wherein the delivery guide member has a diameter distally and proximally of the at least one implant that is substantially equal to the at least one implant delivery diameter, whereby a substantially atraumatic implant delivery system is provided.

27. The system of claim 24 wherein the delivery guide member has no passageway from its proximal to its distal end.

28. The system of claim 24 further comprising an actuator for releasing the at least one releasable joint, and wherein the delivery guide member has only a single passageway from its proximal to its distal end, that passageway contains the actuator, and that actuator does not extend beyond the distal end of the delivery guide member.

29. The system of claim 28 wherein the actuator for releasing the releasable joints is affixed to the distal end of the delivery guide member.

30. The system of claim 24 wherein the at least one implant comprises exactly one implant.

31. The system of claim 24 wherein the at least one implant comprises more than one implant.

32. The system of claim 24 wherein the delivery guide member comprises a distal guide section and a proximal guide section and a gap between the distal guide section and the proximal guide section and the at least one implant is located between the distal guide section and the proximal guide section.

33. The system of claim 24 wherein the delivery guide member has a diameter distally and proximally of the at least one implant, and the at least one implant delivery diameter and delivery guide member diameters are about 0.010 inches to about 0.020 inches, whereby a low-profile delivery system is provided

34. The system of claim 24 wherein the delivery guide member is tubular in form, having a lumen therein.

35. The system of claim 34 further comprising an actuator slidably located at least partially within the delivery guide member lumen and configured to release at least one releasable joint upon axial movement within the delivery guide member.

36. The system of claim 35 wherein the actuator is configured to sequentially release more than one releasable joint upon axial movement within the delivery guide member.

37. The system of claim 35 wherein the actuator is configured to simultaneously release more than one releasable joint upon axial movement within the delivery guide member.

38. The system of claim 34 further comprising an actuator slidably located at least partially within the delivery guide member lumen and configured to release at least one releasable joint upon rotational movement within the delivery guide member.

39. The system of claim 34 wherein at least one releasable joint is configured to release upon application of fluid pressure in the delivery guide member lumen and further comprising a fluid director slidably located at least partially within the delivery guide member lumen and configured to direct fluid to and to release that selected at least one releasable joint.

40. The system of claim 39 wherein the fluid director is configured to sequentially release more than one releasable joint upon application of fluid pressure in the delivery guide member lumen.

41. The system of claim 34 wherein the at least one releasable joint is configured to release upon application of a suitable DC current to the at least one releasable joint and further comprising an electrical conductor located at least partially within the delivery guide member

42. The system of claim 41 wherein the at least one releasable joints and electrical conductors are configured to sequentially release more than one releasable joint.

43. The system of claim 41 wherein the at least one releasable joints and electrical conductors are configured to simultaneously release more than one releasable joint.

44. The system of claim 24 wherein the implant is a stent.

45. The system of claim 44 wherein the stent is unsheathed.

47. The system of claim 24 wherein the implant further comprises a therapeutic agent.

48. The system of claim 47 wherein the therapeutic agent is selected from the group consisting of antibiotics, anticoagulants, antifungal agents, anti-inflammatory agents, antineoplastic agents, antithrombotic agents, endothelialization promoting agents, free radical scavengers, immunosuppressive agents, thrombolytic agents, and combinations thereof.

49. The system of claim 24 wherein the delivery guide member further comprises a radioopaque marker.

50. The system of claim 24 having flexibility and remote directability,

wherein the remote directability is such that a user may direct the distal end of the delivery guide member into and introduce the at least one implant into a coronary artery solely by manipulation of the delivery guide member from its proximal end.

51. The system of claim 24 wherein the the system is guidewireless.

95. The method of claim 81 wherein the stent implant delivery system is selected from those described in any of claims 22-46, 47-51 or 76-79.

100. The system of claim 24 wherein the delivery guide member is noninflatable.

101. The system of claim 25, wherein an atraumatic tip provides the end closure

46. (Cancelled, without prejudice)

52-75. -75. (Cancelled)

76. A system for treating a target site in a tubular organ, the system consisting essentially of:

an elongate delivery guide member having a proximal end and a distal end, the delivery guide member configured to direct at least one implant having an exterior and interior surface to an anatomical treatment site by manipulation by a user, the at least one implant having a delivery diameter prior to release of the at least one implant and located proximally of the distal end of the delivery guide member prior to release, and at least one releasable joint configured to maintain at least a section of the at least one implant at the delivery diameter until release of the at least one releasable joint; and

a balloon catheter,

wherein the delivery guide member is adapted for receipt within a lumen of the balloon catheter.

77. A system consisting essentially of the system of claim 76 and a guidewire, wherein the guidewire is adapted for receipt within a lumen of the balloon catheter.

78. A system consisting essentially of the system of claim 76 and an embolic filter, wherein the embolic filter is attached to the proximal end of the delivery guide.

79. The system of claim 76 wherein the implant is a stent.

80. (Cancelled)

81. A method for treating a target site in a tubular organ of a subject, the method comprising:

accessing a body region;

moving an delivery guide member carrying an implant to a target site in the body region through a balloon catheter lumen;

dilating an area of stenosis at the target site with the balloon catheter; and

releasing the implant at the target site.

82. The method of claim 81 further comprising deploying at least one embolic filter.

83. The method of claim 81 wherein the releasing comprises releasing a distal end of the implant from the delivery guide member before releasing a proximal end of the implant from the delivery guide member.

84. The method of claim 81 wherein the releasing comprises a mechanical detachment process.

85. The method of claim 81 wherein the releasing comprises a hydraulic detachment process.

86. The method of claim 81 wherein the releasing comprises an electrolytic detachment process.

87. The method of claim 81 wherein the body region is a tubular or hollow organ.

88. The method of claim 87 wherein the tubular or hollow organ is selected from the group consisting of blood vessels, arteriovenous malformations, aneurysms, arteriovenous fistulas, cardiac chambers, bile ducts, mammary ducts, fallopian tubes, ureters, large and small airways, stomach, intestines, and bladder.

89. The method of claim 81 wherein the body region is a blood vessel.

90. The method of claim 81 wherein the implant is a stent.

93. The method of claim 81 wherein the subject is human.

94. The method of claim 81 wherein the accessing is performed percutaneously.

96. The method of claim 81 further comprising:

advancing a guidewire to the treatment site;

advancing the balloon catheter over the guidewire to the treatment site; and

exchanging the guidewire for the delivery guide member.

97. The method of claim 81 further comprising:

retracting the balloon catheter so a distal end of the catheter is adjacent the treatment site before the releasing of the implant.

98. The method of claim 81 further comprising:

advancing the delivery guide member beyond a distal end of the balloon catheter.

99. The method of claim 98 where after the advancing of the delivery guide member, the method further comprises retracting the balloon catheter so a distal end of the catheter is adjacent the treatment site before the releasing of the implant.

91-92. -92. (Cancelled)