Implant delivery technologies

• US 20070043419A1
• Filed: 03/23/2004
• Published: 02/22/2007
• Est. Priority Date: 03/26/2003
• Status: Active Grant

• Current Assignee: Biosensors International Group, Ltd.
• Original Assignee: CardioMind, Inc. (Biosensors International Group, Ltd.)
• Inventors: Nikolchev, Julian, George, William, Ton, Dai, Debeer, Nicholas
• Granted Patent: US 7,785,361 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• 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 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing 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
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2250/0071 : breakable or frangible

Abstract

Medical devices (100) and methods for delivery or implantation of prostheses (106) within hollow body organs and vessels (600) or other luminal anatomy are disclosed. The subject technologies may be used in the treatment of atherosclerosis in stenting procedures or for other purposes.

Claims

1. 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.

2. A system consisting essentially of the system of claim 1 and a guidewire, wherein the guidewire is adapted for receipt within a lumen of the balloon catheter.

3. A system consisting essentially of the system of claim 1 and an embolic filter, wherein the embolic filter is attached to the proximal end of the delivery guide member.

4. The system of claim 1, wherein the delivery guide member is positioned within the balloon catheter lumen.

8. The system claim 1, 5 or 6, wherein the delivery guide member is closed at its distal end.

9. The system of claim 8, wherein the distal end is closed by an atraumatic tip.

10. The system claim 1, 5 or 6, wherein the delivery guide member diameter distally and proximally of the at least one implant is about 0.010 inches to about 0.020 inches, whereby a low-profile delivery system is provided.

11. The system claim 1, 5 or 6, wherein the delivery guide member has no passageway from its proximal to its distal end.

12. The system claim 1, 5 or 6, further comprising an actuator for releasing the at least one releasable joint, wherein the delivery guide member has only a single passageway from its proximal to its distal end, that passageway contains the actuator, and wherein that actuator does not extend beyond the distal end of the delivery guide member.

13. The system of claim 12, wherein the actuator for releasing the at least one releasable joint is affixed to the distal end of the delivery guide member.

14. The system claim 1, 5 or 6, 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.

15. The system claim 1, 5 or 6, wherein the delivery guide member is noninflatable.

16. The system of claim 1, 5 or 6, wherein the delivery guide member is tubular in form, having a lumen therein.

17. The system of claim 16, 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.

18. The system of claim 16, 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.

19. The system of claim 16, 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.

20. The system of claim 16, wherein 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 lumen to supply the suitable DC current to and to thereby release at least one releasable joint.

21. The system of claim 20, wherein the at least one releasable joint and electrical conductors are configured to simultaneously release more than one releasable joint.

22. The system of claim 1, 5 or 6, wherein the implant is a stent.

23. The system of claim 1, 5 or 6, wherein the implant is an occlusive coil.

24. The system of claim 1, 5 or 6, wherein the implant further comprises a therapeutic agent.

25. The system of claim 1, 5 or 6, wherein the delivery guide member further comprises a radiopaque marker.

26. The system of claim 1, 5 or 6, having flexibility and remote directability, such that a user may direct the distal end of the 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.

27. The system of claim 1, 5 or 6, wherein the system is guidewireless.

5. An 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 of the delivery guide member 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,

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.

6. An 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, and

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

wherein the system is adapted for sequential release of the releasable joints.

7. A system for treating a target site in a tubular organ comprising:

the implant delivery system of claims 6 or 7, and

a balloon catheter.

28. An implant delivery system comprising:

a self-expanding stent;

a guidewire having a proximal end and a distal end, the guidewire including a reduced diameter distal section, and an atraumatic distal tip; and

a sheath holding the stent in a collapsed configuration over the reduced diameter section.

30. The system of claim 28, wherein the sheath comprises a balloon catheter.

31. A system for treating a target site in a tubular organ comprising:

the implant delivery system of claims 28, 29 or 30, and

a handle for retracting the sheath.

29. An implant delivery system consisting essentially of:

a self-expanding stent;

a guidewire having a proximal end and a distal end, the guidewire including a reduced diameter distal section, and an atraumatic distal tip; and

a sheath holding the stent in a collapsed configuration over the reduced diameter section.

32. A method of retaining an implant, the method comprising:

providing a radially-expandable implant having two ends,

gripping the ends, and

pulling and twisting the ends to maintain the implant in a collapsed configuration until released.

33. The method of claim 32, wherein the gripping is with inactive members.

34. The method of claim 32, wherein the implant is a stent.

35. The method of claim 32, further comprising setting the implant over a core wire.