Medial region deployment of radially self-expanding stents

• US 5,201,757 A
• Filed: 04/03/1992
• Issued: 04/13/1993
• Est. Priority Date: 04/03/1992
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Schneider Electric SE
• Inventors: Berger, Robert L., Johnson, Liann M., Heyn, Lawrence R., Yurek, Matthew T., Basile, Peter A.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US07/863,231
• Time in Patent Office: 375 Days
• Field of Search: 606/191, 606/194, 606/198, 606/200, 623/1, 623/12, 128/898, 604/104-108
• US Class Current: 606/198
• 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 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9534 for repositioning of stents

Abstract

An apparatus for deploying a radially self-expanding stent includes proximal and distal sleeves respectively containing proximal and distal end portions of the stent in a reduced radius delivery configuration. The sleeves can abut one another and thus contain the entire length of the stent, or may be used in combination with an outer catheter surrounding the sleeves and containing the medial region of the stent. In either event, once the stent and sleeves are positioned at the intended fixation site, the sleeves are moved axially with respect to one another to permit radial self-expansion of the stent only over its medial region, while the sleeves continue to contain the axially outward regions of the stent. Eventually, upon sufficient movement of the sleeves axially relative to one another, the stent becomes totally free of the sleeves, resulting in radial expansion over the entire stent length. The axial relative movement of the sleeves can be controlled by two or more catheters mounted movably with respect to one another, one catheter integral with each of the sleeves. Alternative arrangements for separating the sleeves include an externally threaded inner catheter, and a dilatation balloon or membrane expandable to force the sleeves apart from one another.

Claims

1. An apparatus for deploying a radially self-expanding stent within a body lumen, including:

a retaining means for maintaining an elongate, radially self-expanding stent in a delivery configuration wherein the stent has a reduced radius along its entire axial length, the retaining means including a proximal member radially confining a proximal end region of the stent and a distal member radially confining a distal end region of the stent, the proximal and distal members being movable axially with respect to one another toward and away from a confinement position in which the members, while so confining their respective end regions of the stent, cooperate to maintain the stent in the delivery configuration; and

a flexible, elongate delivery means for delivering the stent, when in the delivery configuration and disposed near a distal end of the delivery means, to a deployment site in the body lumen, the delivery means including a control means operably associated with the confinement means for moving the proximal and distal members axially with respect to each other away from the confinement position to allow an initial radial self-expansion of the stent only along a medial region between the end regions as the proximal and distal members continue to radially confine said respective end regions, and further for moving the proximal and distal members axially relative to said respective end regions following the initial self-expansion, to release the stent for radial self-expansion along its entire axial length.

2. The apparatus of claim 1 wherein:

said control means, when moving the proximal and distal members away from the confinement position, moves said members axially away from one another to allow the initial radial self-expansion, and releases the stent by moving the proximal and distal members further axially away from one another following the initial radial self-expansion.

3. The apparatus of claim 2 wherein:

said proximal and distal members respectively comprise proximal and distal sleeves respectively radially confining the proximal and distal regions of the stent.

4. The apparatus of claim 3 wherein:

said proximal and distal sleeves are substantially equal to one another in interior diameter and, when so confining the stent, surround the stent and abut one another along an interface.

5. The apparatus of claim 4 wherein:

said interface is in the radially extended mid-plane of the stent.

6. The apparatus of claim 4 wherein:

said delivery means include a first length of catheter tubing integral with the proximal sleeve and having a first lumen, and wherein the control means includes an elongate moving member running substantially the length of the first catheter tubing and contained within the first lumen, a means securing the moving member integrally with the distal sleeve, and a means for moving the moving member distally with respect to the first catheter tubing.

7. The apparatus of claim 6 wherein:

said moving member comprises a second length of catheter tubing surrounded by the stent and having a second lumen, and the means for securing the moving member include a distal tip fixed to the respective distal ends of the distal sleeve and the second length of catheter tubing.

8. The apparatus of claim 7 wherein:

said delivery means further includes a flexible guide wire contained within the second lumen.

9. The apparatus of claim 8 further including:

a detent means mounted to the second catheter tubing proximally of the stent, to limit proximal movement of the stent with respect to the second- catheter tubing.

10. The apparatus of claim 9 wherein:

said proximal sleeve comprises a distal end portion of the first catheter tubing.

11. The apparatus of claim 8 wherein:

said control means further includes a third length of catheter tubing within the first lumen, surrounding the second catheter tubing, and moveable axially relative to the first catheter tubing and the second catheter tubing.

12. The apparatus of claim 11 wherein:

said stent surrounds the third catheter tubing, and wherein first and second detents are mounted to the third catheter tubing and disposed on opposite sides of the stent, to limit axial travel of the stent with respect to the third catheter tubing.

13. The apparatus of claim 12 wherein:

said proximal sleeve comprises a distal end portion of the first catheter tubing.

14. The apparatus of claim 4 wherein:

said delivery means includes an elongate and flexible guide wire and an elongate dilatation balloon at the distal end of the guide wire, a fastening means for releasably securing the proximal and distal sleeves to one another at the interface with the sleeves surrounding the balloon, and a balloon inflation means for supplying a fluid under pressure to the balloon to effect an elastic expansion of the balloon, the expansion overcoming the retaining force of the fastening means to move the proximal and distal sleeves axially away from one another.

15. The apparatus of claim 14 wherein:

said balloon is annular and surrounds the guide wire.

16. The apparatus of claim 15 further including:

proximal and distal end walls integral with the proximal and distal sleeves, respectively, for further confining the balloon between the sleeves and including respective proximal and distal openings to accommodate the guide wire.

17. The apparatus of claim 16 further including:

a stop mounted integrally on the guide wire distally of the distal end wall and larger than the distal opening.

18. The apparatus of claim 15 wherein:

said balloon inflation means includes a length of catheter tubing having a lumen open to the interior of the balloon, for providing the fluid to the balloon.

19. The apparatus of claim 3 further including:

proximal and distal end walls integral with the proximal and distal sleeves, respectively, and including respective proximal and distal openings;

wherein the control means includes an elongate rotatable member having a first externally threaded section threadedly engaged within one of said proximal and distal openings corresponding to a selected one of the sleeves, and a means for rotating the rotatable member relative to the selected sleeve, thereby axially moving the selected sleeve alternatively toward and away from the other sleeve.

20. The apparatus of claim 19 wherein:

said rotatable member further includes a second threaded section threadedly engaged with the other sleeve, with respective first and second threads following opposite conventions.

21. The apparatus of claim 19 wherein:

said proximal and distal sleeves together surround less than the entire axial length of the stent, and wherein the delivery means includes a length of catheter tubing having a lumen, with a distal portion of the catheter tubing surrounding the proximal and distal sleeves to cooperate with the sleeves in radially confining the stent; and

wherein the rotatable member is contained within the lumen and runs substantially the length of the catheter tubing, the means for rotating the rotatable member being located at a proximal end of the catheter tubing.

22. The apparatus of claim 21, further including:

a means for preventing rotation of the selected sleeve with respect to the catheter tubing while the rotatable member is rotated.

23. The apparatus of claim 3 further including:

proximal and distal end walls integral with the proximal and distal sleeves, respectively;

wherein the control means include an expandable means cooperating with said proximal and distal end walls to form a fluid chamber surrounded by the stent; and

a fluid supply means for supplying a fluid under pressure to the chamber, thereby to expand the expandable means and urge the proximal sleeve and distal sleeve away from one another.

24. The apparatus of claim 23 wherein:

said expandable means is connected to the proximal and distal end walls, whereby said fluid chamber is substantially fluid tight.

25. The apparatus of claim 24 wherein:

said proximal end wall and distal end wall include respective proximal and distal openings; and

wherein the fluid supply means includes a catheter contained in the proximal and distal openings in sliding and substantially sealed relation to the proximal and distal end walls, and a fluid lumen in the catheter open to the chamber.

26. The apparatus of claim 1 wherein:

said control means moves the proximal and distal members axially towards one another to allow the initial radial self-expansion.

27. The apparatus of claim 26 wherein:

said control means includes a proximal detent means for restraining the proximal end region to facilitate movement of the proximal member in the proximal direction relative to the proximal end region, and a distal detent means for restraining the distal end region to facilitate distal movement of the distal member relative to the distal end region.

28. The apparatus of claim 27 wherein:

said proximal and distal members respectively comprise proximal and distal sleeves respectively radially confining the proximal and distal end regions of the stent.

29. The apparatus of claim 28 wherein:

said delivery means includes a handle means, a first elongate moving member integral with the proximal sleeve and mounted at its proximal end for axial movement relative to the handle means, and a second elongate moving member running substantially the length of the first elongate moving member, said second moving member being integral with the distal sleeve and mounted at its proximal portion for axial movement relative to the handle means, and wherein the control means includes means for moving the first and second moving members axially with respect to the handle means.

30. The apparatus of claim 29 wherein:

said first moving member comprises a first length of catheter tubing having a first lumen, and wherein said second moving member comprises a second length of catheter tubing contained within th first lumen, and wherein the proximal end region of the stent is maintained between the second length of the catheter tubing and the proximal sleeve by frictional engagement, and the distal end region of the stent is maintained between the second length of catheter tubing and the distal sleeve by frictional engagement.

31. The apparatus of claim 30 wherein:

said proximal sleeve comprises a distal end portion of the first catheter tubing.

32. The apparatus of claim 30 wherein:

said distal detent means is integrally mounted to the second length of catheter tubing distally of the stent, and the proximal detent means is mounted with respect to the handle means and disposed proximally of the stent.

33. The apparatus of claim 32 wherein:

said distal detent means is mounted slidably on the second length of catheter tubing, and wherein the control means further includes means for maintaining the distal detent means substantially axially fixed relative to the handle means as the second length of catheter tubing is moved distally relative to the handle means.

34. A process for deploying a radially self-expanding stent within a body lumen, including the steps of:

confining a radially self-expanding stent in a reduced radius delivery configuration with a retaining device including proximal and distal members confining respective proximal and distal regions of the stent, while guiding the stent to a point at least proximate a predetermined site within a body lumen and along a tissue wall segment defining the body lumen, the stent including a distal end region, a proximal end region and a medial region between the distal and proximal regions;

with the enclosure at the predetermined site, moving first and second sections of the enclosure axially with respect to one another to permit an initial radial expansion of the stent only along the medial region while confining the proximal and distal regions of the stent against radial expansion with the first and second enclosure sections, respectively; and

after the initial expansion, further moving the first and second enclosure sections axially with respect to one another to allow a self-expansion of the stent progressing axially outwardly of the medial region along the proximal and distal regions, until the stent is free of the first and second enclosure sections and is radially expanded and in contact with the tissue wall segment along its entire axial length.

35. The process of claim 34 including the further step of:

after said initial expansion and prior to said further moving of the enclosure sections, determining whether the stent is positioned at the predetermined site and, responsive to determining the stent is not so positioned, moving the stent and the enclosure sections axially along the tissue wall segment toward the predetermined site.

36. The process of claim 35 including the further step of:

after said step of determining and prior to said step of moving the stent and the enclosure sections axially along the tissue wall segment, moving the first and second enclosure sections axially with respect to one another to at least partially radially contract the medial region of the stent.

37. The process of claim 34 wherein:

at least a portion of the medial region contacts the tissue wall segment after the initial expansion and before said further moving of the enclosure sections.