Stent delivery system

• US 20040006380A1
• Filed: 07/05/2002
• Published: 01/08/2004
• Est. Priority Date: 07/05/2002
• Status: Abandoned Application

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Fulkerson, John D., Buck, Jerrick C., Slater, Charles R., Kratsch, Peter K., Gottlieb, Saul
• Application Number:
  US10/189,993
• Publication Number:
  US 20040006380A1
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod

Abstract

A stent delivery system includes an inner tubular member on which a stent is loaded, an outer jacket extending over said inner tubular member, the retraction of which causes deployment of the stent, and a handle adapted to move the jacket relative to the inner tubular member. The constructions of the inner tubular member and outer jacket and the handle provide increased control of the relative movement of the outer jacket relative to the inner tubular member, and prevention of premature release of the stent from the deployment instrument, and greater control over stent deployment via visual and auditory feedback at the proximal end of the instrument, among other advantages.

Claims

1. A stent delivery system, comprising:

a) an inner tubular member having a distal end;

b) a stent mounted on said distal end of said inner tubular member;

c) an outer jacket longitudinally slidable over said inner tubular member; and

d) a handle adapted to effect longitudinal movement of said jacket relative to said inner tubular member,

wherein at least one of said inner tubular member and said outer jacket comprises a trilayer construction comprising,

i) an inner layer selected from the group of polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), high density polyethylene (HDPE), and urethane,

ii) a middle wire braid layer, and

iii) an outer polyether-based polyamide layer.

2. A stent delivery system according to claim 1, wherein:

both said inner tubular member and said outer jacket includes said trilayer construction.

3. A stent delivery system according to claim 1, wherein:

said trilayer construction is a coextrusion.

4. A stent delivery system according to claim 1, wherein:

said middle wire braid layer is a flat wire braid.

5. A stent delivery system according to claim 1, wherein:

said middle wire braid layer includes wire made from one of a stainless steel alloy and a cobalt-chrome alloy.

6. A stent delivery system according to claim 1, wherein:

said inner tubular member includes a first portion corresponding to a substantial portion of its length and having a first diameter, and a second distal portion having a second diameter smaller than said first diameter,

wherein a shoulder is defined at a junction of said first and second portions.

7. A stent delivery system according to claim 6, wherein:

a raised structure is provided to said distal portion adjacent said shoulder.

8. A stent delivery system, comprising:

a) an inner tubular member having a distal end;

b) a stent mounted on said distal end of said inner tubular member;

c) an outer jacket longitudinally slidable over said inner tubular member; and

d) a handle adapted to effect longitudinal movement of said jacket relative to said inner tubular member,

wherein said outer jacket comprises a trilayer construction comprising,

i) an inner layer selected from the group of polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), high density polyethylene (HDPE), and urethane,

ii) a middle flat wire braid layer, and

iii) an outer polyether-based polyamide layer.

9. A stent delivery system, comprising:

a) an inner tubular member having a distal end;

b) a stent is mounted on said distal end of said inner tubular member;

c) an outer jacket longitudinally slidable over said inner tubular member; and

d) a handle adapted to effect longitudinal movement of said jacket relative to said inner tubular member,

wherein said outer jacket includes a first portion and a relatively distal second portion, said first portion comprising a first trilayer construction comprising,

i) an inner layer selected from the group of polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), high density polyethylene (HDPE), and urethane,

ii) a middle wire braid layer, and

iii) an outer polyether-based polyamide layer, and said second portion comprising a second trilayer construction comprising,

iv) an inner layer selected from the group of PTFE, FEP, HDPE and urethane,

v) a middle tie-layer polymer resin, and

vi) an outer polyether-based polyamide layer,

wherein said first and second portions are substantially seamlessly coupled together.

10. A stent delivery system according to claim 9, wherein:

said second portion is transparent.

11. A stent delivery system according to claim 9, further comprising:

e) a radiopaque marker embedded between said inner layer and said outer layer of said second portion of said outer jacket.

12. A stent delivery system, comprising:

a) an inner tubular member having a length, a first portion corresponding to a substantial portion of said length, said first portion having a first diameter, and a second relatively distal portion having a second diameter smaller than said first diameter, a shoulder integrally defined at a junction of said first and second portions;

b) an outer jacket longitudinally slidable over said inner tubular member; and

c) a stent mounted on said distal portion of said inner tubular member.

13. A stent delivery system according to claim 12, wherein:

said inner tubular member includes a raised structure adjacent said shoulder.

14. A stent delivery system according to claim 13, wherein:

said raised structure extends about a circumference of said second portion of said inner tubular member.

15. A stent delivery system, comprising:

a) an inner tubular member having a distal end provided with a radiopaque tip;

b) an outer jacket longitudinally slidable over said inner tubular member and having a distal end provided with a radiopaque marker; and

c) a stent mounted on said distal end of said inner tubular member, said stent having a plurality of radiopaque markers at each of its ends,

wherein said inner tubular member is absent of radiopaque markers proximal a location at which said stent is mounted.

16. A stent delivery system, comprising:

a) an inner tubular member having a proximal end and a distal end

b) a stent loaded on said distal end of said inner tubular member;

c) an outer jacket longitudinally slidable over said inner tubular member, said outer jacket having a proximal portion with a proximal end, and a distal portion;

d) a handle including a stationary member, a movable member, and a mechanism for moving said movable member relative to said stationary member,

wherein said proximal end of said inner tubular member is fixedly coupled to said stationary member, said proximal end of said outer jacket is fixedly coupled to said movable member; and

e) a sleeve fixedly coupled to said handle and extending over a proximal portion of said outer jacket, said outer jacket being longitudinally movable relative to said sleeve by operation of said handle,

wherein said proximal portion of said outer jacket is provided with one of visible and tactile indicia to visibly or tactily indicate movement of said outer jacket relative to inner tubular member to a user of the system.

17. A stent delivery system, comprising:

a) an inner tubular member having a proximal end and a distal end;

b) a stent loaded on said distal end of said inner tubular member;

c) an outer jacket longitudinally slidable over said inner tubular member and having a proximal end and distal end; and

d) a handle including

i) a stationary member,

ii) a movable member, and

iii) at least one knob rotatably coupled to the stationary member and mechanically coupled to said movable member such that rotation of said at least one knob causes movement of said movable member relative to said stationary member,

wherein said proximal end of said inner tubular member is fixedly coupled to said stationary member, said proximal end of said outer jacket is fixedly coupled to said movable member

18. A stent delivery system according to claim 17, wherein:

said movable member is longitudinally movable relative to said stationary member.

19. A stent delivery system according to claim 17, wherein:

said stationary member defines two sides, and two knobs are rotatably coupled to said stationary member, one on each of said two sides.

20. A stent delivery system according to claim 17, wherein:

said stationary member defines a longitudinal axis, and said at least one knob defines an axis of rotation transverse to and vertically offset relative to said longitudinal axis.

21. A stent delivery system according to claim 17, wherein:

said at least one knob includes a periphery provided with friction-enhancing structure.

22. A stent delivery system according to claim 17, wherein:

said at least one knob includes a periphery provided with friction-enhancing material.

23. A stent delivery system according to claim 17, wherein:

said at least one knob includes a raised grip.

24. A stent delivery system according to claim 17, wherein:

said at least one knob includes a periphery, and an entirety of said periphery is located outside said stationary member and exposed.

25. A stent delivery system according to claim 17, further comprising:

e) means for preventing movement of said outer jacket distally relative to said inner tubular member while permitting movement of said outer jacket proximally relative to said inner tubular member.

26. A stent delivery system according to claim 17, further comprising:

e) locking means for preventing movement of said movable member relative to said stationary member.

27. A stent delivery system according to claim 17, further comprising:

e) a cradle adapted to support said stationary member.

28. A stent delivery system, comprising:

a) an inner tubular member having a proximal end and a distal end;

b) a stent loaded on said distal end of said inner tubular member;

c) an outer jacket longitudinally slidable over said inner tubular member and having a proximal end and distal end; and

d) a handle including a stationary member, a movable member, and a mechanism for moving said movable member relative to said stationary member,

wherein said proximal end of said inner tubular member is fixedly coupled to said stationary member, said proximal end of said outer jacket is fixedly coupled to said movable member, and said mechanism includes

i) first and second sprockets,

ii) a toothed belt extending about said first and second sprockets, said belt being fixedly coupled to said movable member, and

iii) at least one knob extending at least partially outside said stationary member and rotatable relative thereto, said at least one knob being mechanically coupled to said first sprocket such that rotation of said at least one knob causes movement of said belt about said sprockets and longitudinal movement of said outer jacket relative to said inner tubular member.

29. A stent delivery system according to claim 28, wherein:

said mechanism further comprises a gear having first gear teeth, and

said at least one knob includes a periphery provided with radially-inwardly-directed second gear teeth which mesh with said first gear teeth, and said gear is mechanically coupled to said first sprocket.

30. A stent delivery system according to claim 28, wherein:

said stationary member defines two sides, and two knobs are rotatably coupled to said stationary member, one on each of said two sides.

31. A stent delivery system according to claim 29, further comprising:

e) a stiffly resilient element,

wherein said mechanism includes rotatable elements with gear teeth, and said resilient element contacts one of said rotatable elements such that when said one of said rotatable elements is rotated said resilient element is caused to produce an audible clicking sound.

32. A stent delivery system, comprising:

a) an inner tubular member having a distal end;

b) a stent loaded on said distal end of said inner tubular member;

c) an outer jacket longitudinally slidable over said inner tubular member;

d) a handle adapted to move said outer jacket relative to said inner tubular member; and

e) a mechanism adapted to produce an audible sound as said outer jacket is incrementally moved relative to said inner tubular member.

33. A method of preparing a stent delivery system for use with a stent, comprising:

a) selecting a stent of a particular length from stents having a plurality of lengths;

b) providing a stent delivery system having

i) an inner tubular member having a proximal end, and a distal end on which said stent of said particular length is to be mounted,

ii) an outer jacket longitudinally slidable over said inner tubular member and having a proximal end and distal end, and

iii) a handle including a stationary member, a movable member, and a gear assembly for moving said movable member relative to said stationary member, and a manually operable control element which interacts with said gear assembly,

said gear assembly being adapted such that regardless of said particular length of said stent, said control element requires a common movement relative to said stationary member to effect retraction of said outer jacket relative to said inner tubular member to deploy said stent; and

c) loading said stent on said distal end of said inner tubular member.

34. A method of preparing a stent delivery system for use with a stent, comprising:

a) selecting a stent of a particular length from stents having a plurality of lengths;

b) providing a stent delivery system having

i) an inner tubular member having a proximal end, and a distal end on which said stent of said particular length is to be mounted,

ii) an outer jacket longitudinally slidable over said inner tubular member and having a proximal end and distal end,

iii) a handle including a stationary member, a movable member, and a mechanisms that moves said movable member relative to said stationary member, and

iv) a sleeve coupled to said stationary member and extending over said outer jacket, said sleeve having a distal end,

wherein said outer jacket includes one of visible and tactile indicia in a length corresponding to said length of said stent of said particular length, with a proximal end of said indicia being coincident with said distal end of said sleeve; and

c) loading said stent on said distal end of said inner tubular member.