Stent delivery system

• US 6,849,084 B2
• Filed: 12/31/2002
• Issued: 02/01/2005
• Est. Priority Date: 12/31/2002
• Status: Active Grant

• Current Assignee: Intek Technology LLC (Qorvo, Inc.)
• Original Assignee: Intek Technology LLC (Qorvo, Inc.)
• Inventors: Perelson, Ophir, Morag, Eyal, Rabkin, Dmitry, Hadar, Yoram
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): SWEET, THOMAS
• Application Number:
  US10/334,402
• Publication Number:
  US 20040127912A1
• Time in Patent Office: 763 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.23, 606/108
• US Class Current: 623/1.12
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/9662 the middle portion of the stent or stent-graft is released first
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve

Abstract

A first stent delivery system provided with a sheath for covering the stent, the sheath including proximal sheath portion adapted to be movable in a proximal direction and a distal sheath portion adapted to be moveable in a distal direction. A second stent delivery system including an outer and intermediate tubular members covering a chamber with a preloaded stent, the outer tubular member being retractable prior to the retraction of the intermediate sheath and release of the stent. A third stent delivery system including with an inflatable balloon at a distal end of the system for fixing the system in place within the vessel prior to the release of the stent thereby insure accurate stent deployment.

Claims

1. A stent delivery system comprising:

a catheter system including an elongate member including a chamber arranged at a distal end of said system, said chamber being structured and arranged to receive a preloaded stent;

a sheath for covering said stent receiving section, said sheath having a proximal sheath portion extending over a proximal portion of said chamber and structured and arranged to be moveable in a proximal direction and a distal sheath portion extending over a distal portion of said chamber structured and arranged to be moveable in a distal direction; and

means for controlling the movement of said proximal sheath portion in said proximal direction and means for controlling the movement of said distal sheath portion in said distal direction;

wherein said means for controlling the movement of said proximal sheath portion in said proximal direction and the movement of said distal sheath portion in said distal direction comprises;

a rotatable proximal housing; and

a stationary distal housing operably coupled to said rotatable outer proximal housing;

wherein said rotatable proximal housing includes an internal throat portion; and

wherein said means for controlling the movement of said proximal sheath portion in said proximal direction and the movement of said distal sheath portion in said distal direction further comprises;

an annular sleeve operably coupled to said throat portion of said rotatable proximal housing such that upon rotation of said rotatable proximal housing said annular sleeve moves in a distal direction.

2. The stent delivery system according to claim 1, further comprising:

an inner tubular member having a first and a second end, said first end of said inner tubular member operably coupled to said means for manually controlling the movement of said distal sheath portion in said distal direction, said second end of said inner tubular member operably coupled to said distal sheath portion.

3. The stent delivery system according to claim 2, wherein said proximal sheath portion is operably coupled to said means for controlling the movement of said proximal sheath portion in said proximal direction and the movement of said distal sheath portion in said distal direction.

4. The stent delivery system according to claim 3, wherein said means for controlling the movement of said proximal sheath portion in said proximal direction and the movement of said distal sheath portion in said distal direction further comprises:

a cup shaped insert operably coupled to said rotatable proximal housing such that upon rotation of said rotatable proximal housing said cup shaped insert moves in a proximal direction; and

wherein said proximal sheath portion is coupled to said cup shaped insert such that upon rotation of said rotatable proximal housing said proximal sheath portion moves in a proximal direction.

5. The stent delivery system according to claim 2, wherein said inner tubular member has a guidewire lumen.

6. The stent delivery system according to claim 2, wherein said inner tubular member has a multichannel construction, one of said channels being structured and arranged to receive a guidewire and another one of said channels being structured and arranged to permit simultaneous flushing or instillation of fluid.

7. The stent delivery system according to claim 1, wherein said means for controlling the movement of said proximal sheath portion in said proximal direction and the movement of said distal sheath portion in said distal direction further comprises:

a plunger operably coupled to an inner tubular member, said plunger being operably coupled to said annular sleeve during at least a selected phase of movement of said annular sleeve such that upon rotation of said rotatable proximal member said plunger moves conjointly with said annular sleeve in a distal direction thereby moving said distal sheath portion in said distal direction.

8. The stent delivery system according to claim 1, wherein said proximal sheath portion terminates at a distal edge and said distal sheath portion terminates at a proximal edge, said distal edge of said proximal sheath portion and said proximal edge of said distal sheath portion initially abut one other so that said sheath initially completely a stent.

9. The stent delivery system accordingly to claim 8, wherein said distal edge of said proximal sheath portion and said proximal edge of said distal sheath portion initially abut one another at a location that substantially corresponds to a midpoint of said stent.

10. A stent delivery system comprising:

a catheter system including an elongate member including a chamber arranged at a distal end of said system, said chamber being structured and arranged to receive a preloaded stent;

a sheath for covering said stent receiving section, said sheath having a proximal sheath portion extending over a proximal portion of said chamber and structured and arranged to be moveable in a proximal direction and a distal sheath portion extending over a distal portion of said chamber structured and arranged to be moveable in a distal direction; and

means for controlling the movement of said proximal sheath portion in said proximal direction and means for controlling the movement of said distal sheath portion in said distal direction;

wherein said means for controlling the movement of said proximal sheath portion in said proximal direction and the movement of said distal sheath portion in said distal direction further comprises;

a plunger operably coupled to an inner tubular member, said plunger being operably coupled to an annular sleeve during at least a selected phase of movement of said annular sleeve such that upon rotation of said rotatable proximal member said plunger moves conjointly with said annular sleeve in a distal direction thereby moving said distal sheath portion in said distal direction; and

wherein said means for controlling the movement of said proximal sheath portion in said proximal direction and the movement of said distal sheath portion in said distal direction further comprises;

a locking mechanism, said locking mechanism being structured and arranged to prevent the distal movement of said plunger during an initial phase of movement of said annular sleeve and permit said plunger to move conjointly with said annular sleeve during said selected phase of movement of said annular sleeve in the system, when the junction of said distal and proximal sheath portions are located initially towards a distal end of said stent receiving section.

11. The stent delivery system according to claim 10, wherein said locking mechanism comprises:

at least one lock arm having a foot portion and a head portion;

and at least one lock hinge having a shoulder portion and a arm portion;

wherein said shoulder portion of said lock hinge is arranged in abutting contact with a head of said plunger to thereby prevent the distal movement of said plunger during said initial phase of movement of said annular sleeve;

wherein said lock hinge is biased to move to a clearance position relative to said head of said plunger and said head portion of said lock arm is placed in abutting contact with said arm portion of said lock hinge during said initial phase of movement of said annular sleeve to thereby prevent said lock hinge from moving to said clearance position thereby maintaining said shoulder portion of said lock hinge in abutment with said head of said plunger.

12. The stent delivery system according to claim 11, wherein a cup shaped insert has a leading proximal surface that is placed into contact with said foot portion of said at least one lock arm when said cup shaped portion moves in said proximal direction, said proximal surface being placed into contact with said foot portion at substantially the same time as a commencement of said selected phase of movement of said annular sleeve, said proximal surface of said cup shaped insert applying a force to said foot portion of said at least one arm to thereby move said lock are in a proximal direction thereby moving said head of said lock arm out of abutting contact with said abutting contact with said arm portion of said lock hinge permitting said lock hinge to move to clearance position thereby permitting said plunger to move in a distal direction.

13. The stent delivery system according to claim 12, wherein said plunger includes a stem portion that extends distally from said head of said plunger, said stem portion structured and arranged so that it extends into an axial bore of said annular sleeve, said stem portion having an outer surface and a radially outwardly extending lip that extends outwardly from said outer surface, and

wherein said annular sleeve has an inner surface and a radially inwardly extending lip, and

wherein at said commencement of said selected phase of movement of said annular sleeve said radially outwardly extending lip of said stem portion is placed in abutment with said radially inwardly extending lip of said annular sleeve such that further movement of said annular sleeve in said distal direction causes said plunger to move in said distal direction.

14. The stent delivery system according to claim 13, wherein said cup shaped insert has an external surface provided with at least one recessed axial channel and an internal surface of said stationary distal housing is provided with at least one key structured and arranged to mate with said at least one recessed axial channel, said at least one recessed axial channel and said at least one key cooperating to permit an axial movement of said cup shaped insert while at the same time preventing a rotational movement of said cup shaped insert.

15. A stent delivery system comprising:

a catheter system including an elongate member including a chamber arranged at a distal end of said system, said chamber being structured and arranged to receive a preloaded stent;

a sheath for covering said stent receiving section, said sheath having a proximal sheath portion extending over a proximal portion of said chamber and structured and arranged to be moveable in a proximal direction and a distal sheath portion extending over a distal portion of said chamber structured and arranged to be moveable in a distal direction; and

means for controlling the movement of said proximal sheath portion in said proximal direction and means for controlling the movement of said distal sheath portion in said distal direction;

wherein said means for controlling the movement of said proximal sheath portion in said proximal direction and the movement of said distal sheath portion in said distal direction comprises;

a rotatable proximal housing; and

a stationary distal housing operably coupled to said rotatable outer proximal housing;

wherein said rotatable proximal housing includes an internal throat portion; and

wherein said means for controlling the movement of said proximal sheath portion in said proximal direction and the movement of said distal sheath portion in said distal direction further comprises;

an annular sleeve operably coupled to said throat portion of said rotatable proximal housing such that upon rotation of said rotatable proximal housing said annular sleeve moves in a distal direction

wherein said means for controlling the movement of said proximal sheath portion in said proximal direction and the movement of said distal sheath portion in said distal direction further comprises;

a plunger operably coupled to an inner tubular member, said plunger being operably coupled to said annular sleeve during at least a selected phase of movement of said annular sleeve such that upon rotation of said rotatable proximal member said plunger moves conjointly with said annular sleeve in a distal direction thereby moving said distal sheath portion in said distal direction; and

wherein said means for controlling the movement of said proximal sheath portion in said proximal direction and the movement of said distal sheath portion in said distal direction further comprises;

means for operably coupling said plunger to said annular sleeve such that as soon as said annular sleeve begins moving in a distal direction said plunger and said distal portion of said sheath also move conjointly with said sleeve in said distal direction when a junction between said proximal and distal sheath portions is initially arranged over a middle portion of said stent receiving section.

16. A stent delivery system comprising:

a sheath for covering a stent, said sheath having a proximal sheath portion structured and arranged to be moveable in a proximal direction and a distal sheath portion structured and arranged to be moveable in a distal direction;

means for controlling the movement of said proximal sheath portion in said proximal direction and means for controlling the movement of said distal sheath portion in said distal direction;

wherein said means for controlling the movement of said proximal sheath portion in said proximal direction and the movement of said distal sheath portion in said distal direction comprises;

a rotatable proximal housing; and

a stationary distal housing operably coupled to said rotatable outer proximal housing;

wherein said rotatable proximal housing includes an internal throat portion; and

wherein said means for controlling the movement of said proximal sheath portion in said proximal direction and the movement of said distal sheath portion in said distal direction further comprises;

an annular sleeve operably coupled to said throat portion of said rotatable proximal housing such that upon rotation of said rotatable proximal housing said annular sleeve moves in a distal direction; and

whereby when said proximal sheath portion is moved in said proximal direction and said distal sheath portion is moved in said distal direction a middle portion of said stent is exposed prior to the exposure and expansion of the terminal end portions of said stein.

17. The stent delivery system according to claim 16, further comprising means for controlling the movement of said proximal sheath portion in said proximal direction and the movement of said distal sheath portion in said distal direction, said means comprising:

at least a first member moveable in a proximal direction, said first member operably coupled to said proximal sheath portion; and

at least a second member movable in a distal direction, said second member operably coupled to said distal sheath portion.

18. The stent delivery system according to claim 17, wherein said means for controlling the movement of said proximal sheath portion in said proximal direction and the movement of said distal sheath portion in said distal direction is manually operable by an operator.

19. A catheter assembly for delivering and deploying a self-expanding stent, comprising:

an elongate member having an axially extending stent-mounting portion at a distal end region thereof;

a self-expanding stent having proximal and distal ends coaxially mounted in a collapsed configuration on said stent-mounting portion of said elongate member;

an outer tubular proximal sheath portion coaxially mounted on said elongate member at said distal region thereof, said proximal sheath portion having a distal end and being structured and arranged to move between a closed position in which said distal end of said proximal sheath portion overlies said stent and is situated between the ends of said stent, and an open position in which said distal end of said proximal sheath portion, does not overlie said stent and is situated proximally of said proximal end of said stent;

an outer tubular distal sheath portion coaxially mounted on said elongate member at said distal region thereof, said distal sheath portion having a proximal end and being structured and arranged to move between a closed position in which said proximal end of said distal sheath portion overlies said stent and is situated between the ends of said stent, and an open position in which said proximal end of said distal sheath portion does not overlie said stent and is situated distally of said distal end of said stent;

means for controlling the movement of said proximal sheath portion situated in part at, and operable from, a proximal end region of said catheter assembly for controlling the movement of said proximal sheath portion in said proximal direction and distal sheath portions in said distal direction from said closed to said open positions thereof

wherein said means for controlling the movement comprises;

a rotatable proximal housing; and

a stationary distal housing operably coupled to said rotatable outer proximal housing;

wherein said rotatable proximal housing includes an internal throat portion; and

wherein said means for controlling the movement of said proximal sheath portion in said proximal direction and the movement of said distal sheath portion in said distal direction further comprises;

an annular sleeve operably coupled to said throat portion of said rotatable proximal housing such that upon rotation of said rotatable proximal housing said annular sleeve moves in a distal direction; and

whereby said stent is delivered to a desired treatment site within said vessel while mounted in a collapsed configuration on said stent-mounting portion of said elongate member with said proximal and distal sheath portions situated in their closed positions restraining the expansion of said stent, and is deployed at said treatment site by operation of said means for controlling to move said proximal and distal sheath portions to their open positions to allow the expansion and deployment of said stent.

20. The catheter assembly for delivering and deploying a self-expanding stent according to claim 19, wherein when in their closed positions said proximal end of said distal sheath portion and said distal end of said proximal sheath portion are in mutual engagement.

21. The catheter assembly for delivering and deploying a self-expanding stent according to claim 19, wherein when in their closed positions, the proximal and distal sheath portions overlie the entire stent.

22. The catheter assembly for delivering and deploying a self-expanding stent according to claim 19, wherein said control mechanism includes means for moving said proximal and distal sheath portions from there closed positions to their open positions in a coordinated manner.

23. The catheter assembly for delivering and deploying a self-expanding stent according to claim 19, wherein said proximal and distal sheath portions comprise separate and distinct members.

24. An elongate catheter assembly for delivering and deploying a self-expanding stent, comprising:

an elongate member having an axially extending stent-mounting portion at a distal end region thereof;

an outer tubular proximal sheath portion coaxially mounted on said elongate member at said distal region thereof, said proximal sheath portion being structured and to move between a closed position in which said proximal sheath portion partially overlies said stent-mounting portion of said elongate member, and an open position in which said proximal sheath portion does not overlie said stent-mounting portion of said elongate member or any part thereof;

an outer tubular distal sheath portion coaxially mounted on said elongate member at said distal region thereof, said distal sheath portion being structured and arranged to move between a closed position in which said distal sheath portion partially overlies said stent-mounting portion of said elongate member, and an open position in which said distal sheath portion does not overlie said stent-mounting portion or any part thereof;

a means for controlling the movement situated in part at, and operable from, a proximal end region of said catheter assembly for controlling the movement of said proximal and distal sheath portions from said closed to said open positions thereof;

wherein said means for controlling the movement comprises;

a rotatable proximal housing; and

a stationary distal housing operably coupled to said rotatable outer proximal housing;

wherein said rotatable proximal housing includes an internal throat portion; and

wherein said means for controlling the movement further comprises;

an annular sleeve operably coupled to said throat portion of said rotatable proximal housing such that upon rotation of said rotatable proximal housing said annular sleeve moves in a distal direction; and

whereby a stent is delivered to a desired treatment site within said vessel while mounted in a collapsed configuration on said stent-mounting portion of said elongate member with said proximal and distal sheath portions situated in their closed positions restraining the expansion of the stent, and is deployed at said treatment site by operation of said means for controlling to move said proximal and distal sheath portions to their open positions to allow the expansion and deployment of the stent.

25. The catheter assembly for delivering and deploying a self-expanding stent according to claim 24, wherein when in their closed positions said proximal end of said distal sheath portion and said distal end of said proximal sheath portion are in mutual engagement.

26. The catheter assembly for delivering and deploying a self-expanding stent according to claim 24, wherein when in their closed positions, the proximal and distal sheath portions overlie the entire stent.

27. The catheter assembly for delivering and deploying a self-expanding stent according to claim 24, wherein said control mechanism includes means for moving said proximal and distal sheath portions from there closed positions to their open positions in a coordinated manner.

28. The catheter assembly for delivering and deploying a self-expanding stent according to claim 24, wherein said control mechanism includes means for moving one of said proximal and distal sheath portions without moving the other of said proximal and distal sheath portions.

29. The catheter assembly for delivering and deploying a self-expanding stent according to claim 24, wherein said proximal and distal sheath portions comprise separate and distinct members.