STENT SYSTEMS

• US 20080221666A1
• Filed: 12/14/2007
• Published: 09/11/2008
• Est. Priority Date: 12/15/2006
• Status: Abandoned Application

• Current Assignee: Biosensors International Group, Ltd.
• Original Assignee: CardioMind, Inc. (Biosensors International Group, Ltd.)
• Inventors: Turovskiy, Roman, Ton, Dai T., George, William R., Licata, David, Liu, James C., Pandya, Sudip
• Application Number:
  US11/957,211
• Publication Number:
  US 20080221666A1
• Time in Patent Office: Days
• US Class Current: 623/1.22
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• 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

Medical devices and methods for delivery or implantation of prostheses within hollow body organs and vessels or other luminal anatomy are disclosed. The subject technologies can be used in the treatment of atherosclerosis in stenting procedures or be used in variety of other procedures. The systems can employ a self expanding stent restrained by one or more members released by an electrolytically erodable latch.

Claims

1. A stent delivery system including an elongate delivery guide comprising:

a stent comprising a near end, a far end and a structure extending therebetween, the stent further comprising a near and a far mating portion at the near and far ends of the stent, near and far seats at a far portion of the delivery guide, a mating portion being received in each seat, at least one helical wrap including an electrolytically erodable section, the wrap at least partially covering at least one of the seats and mating portions received therein, and an insulative polymer sleeve interposed between the wrap and the mating portions.

2. The system of claim 1, wherein the stent is in a twisted configuration.

3. The system of claim 1, wherein only one seat is covered by a helical wrap, and wherein at least one seat is rotatable upon release of an electrolytically erodible member.

4. The system of claim 1, wherein the sleeve has a thickness of about 0.001 inches or less.

5. The system of claim 1, wherein the sleeve is slit along a plurality of lines between the mating portions.

6. A stent delivery system including an elongate delivery guide comprising:

a stent comprising a near end, a far end and a structure extending therebetween, the stent further comprising a near and a far mating portion at the near and far ends of the stent, near and far seats at a far portion of the delivery guide, one mating portion being received in one seat and the other mating portion being receiving in the other seat, one of the seats being rotatable, and near far restraints for holding portions of the stent in a compressed state, one of the restraints including a helical wrap having an electrolytically erodable section, the wrap at least partially covering one of the seats and mating portions received therein.

7. The system of claim 6, wherein the stent is in a twisted state.

8. The system of claim 7, wherein the stent has a closed cell construction.

9. The system of claim 6, further including a sleeve positioned around one of the seats and the wrap is secured to the seat over the sleeve.

10. A method of loading a stent delivery system comprising:

securing the first end of a stent having first and second ends to a first seat that is fixed to a delivery guide, the first end being secured to the first seat with a wrapping member, securing the second end of the stent to a second seat that is coupled to the delivery guide, twisting the stent into a twisted configuration while the second end of the stent is secured to a second seat with a restraint, and fixing the second seat to the delivery guide.

11. The method of claim 10, wherein the second restraint is fixed to the delivery guide after twisting the stent.

46. The method of claim 10 wherein the restraint comprises, a coil.

12. A method of implant delivery comprising:

introducing an implant delivery system in an electrolytic fluid; and

applying electrical power to a delivery guide having at least one electrolytically erodable member, the power having an AC voltage component with a peak-to-peak configuration of at least about 5V, and a DC voltage signal of at least about 1V, wherein the DC component is increased from zero to a maximum over a period of at least about 0.1 seconds.

13. The method of claim 12, wherein the DC component is increased from zero to a maximum over a period of at least about 0.5 seconds.

14. The method of claim 12, wherein the DC component is increased from zero to a maximum over at least about 1 second.

15. The method of claim 12, wherein the DC voltage varies to deliver a constant current during electrolytic erosion.

16. The method of claim 15, wherein the DC voltage varies between about 1V and 9.5V.

17. The method of claim 12, wherein the AC voltage component has a peak-to-peak configuration of 20V or less.

18. The method of claim 12, wherein the AC voltage component has a peak-to-peak configuration of 15V or less.

19. The method of claim 12, wherein the AC component has a substantially square-wave profile.

20. The method of claim 12, where the power applied includes a negative voltage signal.

21. The method of claim 20, wherein the power-applied always includes a negative voltage signal.

22. The method of claim 12, wherein the power delivered to each electrically erodable member having an AC voltage component has a peak-to-peak configuration of at least about 5V, and a DC voltage signal of at least about 1V.

23. A implant delivery guide body comprising:

an elongate body, the body comprising a proximal metal tube, a distal metal tube, a corewire, and a superelastic helical wrap, the core wire connecting the proximal and distal tubes, the wrap overlaying at least one junction between the proximal and distal tubes.

24. The delivery guide body of claim 23, wherein the wrap comprises NiTi material.

25. The delivery guide body of claim 23, wherein the covered junction comprises a joint.

26. The delivery guide of body claim 25, wherein the joint comprises conductive material.

27. The delivery guide of body claim 23, wherein the wrap is soldered at two ends.

28. The delivery guide of body claim 23, wherein the wrap comprises ribbon.

29. The delivery guide of body claim 23, wherein the wrap comprises round wire.

30. The delivery guide of body claim 23, wherein the delivery guide has a substantially uniform outside diameter due to the wrap.

31. The delivery guide of body claim 30, wherein the outside diameter ranges from about 0.012 to about 0.014 inches.

32. A stent delivery system comprising:

an implant delivery guide body comprising a proximal metal tube, a distal metal tube, a corewire, and a superelastic helical wrap, the core wire connecting the proximal and distal tubes, the wrap overlaying at least one junction between the proximal and distal tubes, and a stent releasably mounted adjacent a distal end of the guide body.

33. A stent delivery system comprising:

an elongate-delivery guide body, and a stent releasably secured to the delivery guide body, the stent held in a twisted, compressed profile for delivery, over a mandrel, a plurality of hollow cylindrical members interposed between the stent and the mandrel, wherein the hollow members are rotatable about the mandrel at least prior to holding the stent in its delivery profile.

34. The stent delivery system of claim 33, wherein the mandrel is formed of metal tubing.

35. The stent delivery system of claim 34, wherein the cylindrical elements have a wall thickness of between about 0.0005 and about 0.0015 inches.

36. The stent delivery system of claim 33, wherein substantially an entire support region of the stent contacts the cylindrical members.

37. The system of claim 36, wherein the stent includes end projections, and no cylindrical members are in contact with the end projections.

38. The system of claim 33, wherein the plurality of hollow cylindric members, comprises at least 3 members.

39. A method of loading a stent delivery system, the method comprising:

rotating at least one of a stent not over a mandrel, onto a plurality of rollers on the mandrel;

progressively spinning the rollers as the stent progressively assumes a compressed diameter, and securing the stent to the delivery system.

40. The method of claim 39, wherein the stent is a non-coil type stent.

41. The method of claim 39, wherein a first end of the stent is initially secured to the delivery system, and a second end is rotated and then secured of the delivery system.

42. A self-expanding stent comprising:

a body portion have a closed cell lattice construction, a longitudinal axis when in relaxed state, and distal and proximal ends;

a plurality of distal projections extending from said distal end and a plurality of proximal projections extending from said proximal end, the distal and proximal projections extending in a direction generally parallel to the longitudinal axis, and, the proximal projections being longer than said distal projections.

43. The self-expanding stent of claim 42 wherein said proximal projections are at least twice as long as the distal projections.

44. A stent delivery guide comprising a delivery guide having a first length having a proximal and distal end portion, a second length having a proximal and distal end portion, a self-expanding stent having a proximal and distal end portion, and a coil having a proximal and distal end the first length distal end portion being coupled to the second length proximal end portion, the second length distal end portion being coupled toe the proximal end of the stent and the distal end of the stent being coupled to the proximal end of the coil, which forms the distal tip of the delivery guide, the first length being less flexible than the second length.

45. The stent delivery guide of claim 44 where the stent is in a twisted state and has a closed cell construction.

47. A method for delivering a balloon catheter to a lesion site comprising:

positioning a stent carrying delivery guide with a self-expanding stent releasably coupled thereto at a location in a vessel with the stent near a lesion site;

tracking a balloon catheter with an expandable balloon over the stent carrying delivery guide to the lesion site and dilating the lesion site with the balloon catheter;

moving the balloon catheter to allow release of the stent at the lesion site, while maintaining the balloon catheter tracked over the stent carrying delivery guide;

deploying the stent from the stent carrying delivery guide at the lesion site;

moving the balloon catheter over the delivery guide and positioning the balloon catheter balloon at the lesion site; and

manipulating the balloon catheter to effect post stent deployment dilation of the lesion site.