STENT DELIVERY SYSTEM

• US 20110196472A1
• Filed: 03/29/2011
• Published: 08/11/2011
• Est. Priority Date: 09/30/2008
• Status: Abandoned Application

• Current Assignee: Terumo Kabushiki Kaisha (Terumo Corporation)
• Original Assignee: Terumo Kabushiki Kaisha (Terumo Corporation)
• Inventors: SUGIMOTO, Ryota, Kitaokia, Takashi
• Application Number:
  US13/074,519
• Publication Number:
  US 20110196472A1
• Time in Patent Office: Days
• 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 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

Abstract

A stent delivery system includes a self-expandable stent, a shaft section having a guide wire lumen, and a sheath having distal portion containing the stent. The stent is located at a position which is on the shaft section and near the distal end of the shaft section. The stent delivery system has a stent proximal portion fixing wire and a breaking member. The stent proximal portion fixing wire has one end portion and the other end portion which are fixed to the shaft section, and also has an intermediate portion engaged with a proximal portion of the stent. The breaking member breaks the stent proximal portion fixing wire to release the stent from the engagement.

Claims

1. A stent delivery system comprising:

a shaft section through which extends a guide wire lumen which is open at opposite ends for receiving a guide wire to guide the stent delivery system to a desired position within a living body;

a sheath encircling at least a distal portion of the shaft section so that an inner surface of the sheath faces an outer surface of the shaft section, with a space between the inner surface of the sheath and the outer surface of the shaft section, the sheath being movable in a proximal direction relative to the shaft section;

a self-expandable stent possessing a central axis and a proximal end, the stent encircling the distal portion of the shaft section and being positioned in the space between the inner surface of the sheath and the outer surface of the shaft section so that the sheath covers the stent;

the stent being compressed inwardly towards the central axis of the stent while covered by the sheath, and automatically expanding outwardly into a pre-compression shape when the sheath is moved in the proximal direction relative to the shaft section to a position no longer covering the stent;

the stent comprising a plurality of through openings at a proximal end of the stent;

a breakable fixing wire comprising a first portion and a second portion both fixed to the shaft section so that the first portion and the second portion of the breakable fixing wire move together as a unit with the shaft section, the breakable fixing wire comprising a third portion spaced from the first portion and the second portion, the third portion of the breakable fixing wire passing through the through openings at the proximal end of the stent so that the breakable fixing wire engages the stent and holds the stent relative to the shaft section; and

means for breaking the fixing wire to release the stent from engagement by the other portion of the fixing wire, the third portion of the fixing wire being a portion of the fixing wire between the first portion and the second portion.

2. The stent delivery system according to claim 1, wherein the means for breaking is a heating unit which generates heat.

3. A stent delivery system that delivers a stent to a desired position in a living body, the stent delivery system comprising:

a cylindrically shaped stent possessing a central axis, the stent being compressed toward the central axis of the stent at the time of insertion into a living body, the stent being configured to automatically expand outwardly when placed in the living body to be restored into a pre-compression shape;

a shaft section having a guide wire lumen, the shaft section possessing a distal end and a proximal end;

a sheath containing the stent, the stent being located on the shaft section at a position near the distal end of the shaft section;

a stent proximal portion fixing wire possessing one end portion and an other end portion, the one end portion and the other end portion of the stent proximal portion fixing wire being fixed to the shaft section;

the stent proximal portion fixing wire also possessing an intermediate portion which is in engagement with a proximal portion of the stent; and

a breaking member for breaking the stent proximal portion fixing wire to release the stent from engagement by the intermediate portion of the stent proximal portion fixing wire.

4. The stent delivery system according to claim 3, wherein the proximal portion of the stent includes a plurality of through holes arranged in an annular pattern, the intermediate portion of the stent proximal portion fixing wire passing through the plurality of through holes.

5. The stent delivery system according to claim 3, wherein the shaft section comprises a shaft body and a distal tube, the distal tube being provided with the guide wire lumen, the shaft body having a distal portion fixed to a proximal end portion of the distal tube, and the breaking member is secured to the distal portion of the shaft body.

6. The stent delivery system according to claim 3, wherein the stent has a distal portion oriented toward a distal side of the sheath and the proximal portion oriented toward a proximal side of the sheath, the stent being devoid of any free bent end projecting toward the proximal side, other than at a proximal-most end portion of the stent, the sheath being movable in a proximal direction relative to the shaft section to expose the distal portion of the stent, the sheath being movable in a distal direction relative to the shaft section after exposing the distal portion of the stent so that the distal portion of the stent is once again covered by the sheath.

7. The stent delivery system according to claim 3, wherein the stent proximal portion fixing wire is breakable upon application of heat, and the breaking member comprises a heating unit which generates heat.

8. The stent delivery system according to claim 7, wherein the heating unit is connected to electric cables fixed to an outer surface of the shaft section, the electric cables being connected to a joint section at a proximal portion of the shaft section.

9. The stent delivery system according to claim 3, wherein the shaft section has a proximal-side opening communicating with the guide wire lumen and through which the guide wire is adapted to be passed, wherein the proximal-side opening opens to a side portion of the shaft section at a position spaced from distal and proximal ends of the shaft section, the proximal-side opening being located proximally of a proximal-most end of the stent.

10. The stent delivery system according to claim 3, wherein the sheath is proximally movable relative to the shaft section to expose the stent and allow the stent to automatically expand outwardly, the sheath being distally movable relative to the shaft section after the stent has automatically expanded outwardly to once again cover the stent until the stent is released from the engagement by the intermediate portion of the stent proximal portion fixing wire.

11. The stent delivery system according to claim 3, wherein the stent proximal portion fixing wire is a thermoplastic resin fiber.

12. The stent delivery system according to claim 3, further comprising stopper secured to the shaft section to restrain the stent from moving in a proximal direction, the stopper being positioned proximally of the proximally relative to the proximal end of the stent.

13. The stent delivery system according to claim 12, wherein the stopper is a spring wound around the shaft section.

14. The stent delivery system according to claim 13, wherein the stent proximal portion fixing wire extends, from the one end portion and the other end portion, in a distal direction toward the stent by passing through a gap in a coil constituting the spring.

15. The stent delivery system according to claim 3, wherein the proximal portion of the stent includes a plurality of through holes arranged in an annular pattern, the intermediate portion of the stent proximal portion fixing wire passing through the plurality of through holes, each of the through holes possessing one of a low-friction inner surface or a tapered inner diameter to facilitate release of the stent proximal portion fixing wire.

16. The stent delivery system according to claim 3, wherein the stent comprises a plurality of wave-shaped struts extending in a axial direction of the stent from one axial end to an opposite axial end of the stent, the wave-shaped struts being circumferentially arranged and spaced apart from one another, the stent also comprising connecting struts each interconnecting circumferentially adjacent wave-shaped struts, the connecting struts extending in the axial direction over a predetermined length shorter than the wave-shaped struts, the wave-shaped struts each having end portions, each end portion of each wave-shaped strut being connected to the end portion of the circumferentially adjacent wave-shaped strut.

17. The stent delivery system according to claim 16, wherein the connecting struts are each curved in a circular arc shape.

18. The stent delivery system according to claim 16, wherein each end portion of each wave-shaped strut is connected to the end portion of the circumferentially adjacent wave-shaped strut at a joint section, and wherein a through hole extends through each of the joint sections to thus provide a plurality of through holes arranged in an annular pattern, the intermediate portion of the stent proximal portion fixing wire passing through the plurality of through holes.

19. A method of operating a stent delivery system to deliver a stent to a desired position in a living body, the method comprising:

positioning a distal portion of a stent delivery system at a desired location in a living body lumen, the stent delivery system comprising;

a shaft section;

a sheath surrounding a distal portion of the shaft section with an annular space between the shaft section and the sheath;

a self-expandable stent surrounding the distal portion of the shaft section, positioned in the space, and covered by the sheath, the stent being compressed toward a central axis of the stent and configured to automatically expand outwardly when the sheath is moved in a proximal direction relative to the shaft section to expose the stent; and

a stent proximal portion fixing wire having one end portion fixed to the shaft section and an other portion in engagement with a proximal portion of the stent;

proximally moving the sheath relative to the stent to uncover the stent and allow the stent to automatically expand outwardly, except for the proximal portion of the stent which continues to be engaged by the other portion of the stent proximal portion fixing wire in a manner preventing the proximal portion of the stent from expanding outwardly; and

breaking the stent proximal portion fixing wire to release the proximal portion of the stent and allow the proximal portion of the stent to automatically expand outwardly.

20. The method according to claim 19, further comprising, after proximally moving the sheath to uncover the stent and before breaking the stent proximal portion fixing wire, distally moving the sheath to a position in which the sheath once again covers the stent.