Non-deformable self-expanding parallel flow endovascular stent and deployment apparatus therefore

• US 5,549,635 A
• Filed: 04/03/1995
• Issued: 08/27/1996
• Est. Priority Date: 01/24/1994
• Status: Expired due to Term

• Current Assignee: X Technologies, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Solar, Rita & Gaterud, Ltd.
• Inventors: Solar, Ronald J.
• Primary Examiner(s): Thaler, Michael H.
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/415,846
• Time in Patent Office: 512 Days
• Field of Search: 623/1, 623/11, 623/12, 606/108, 606/191, 606/194, 606/195, 606/198, 604/96
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 non-deformable, self-expanding stent device, and deployment catheter therefore. The stent device comprises an elongate wire member having a multiplicity of back and forth bends formed therein to define a series of side-by-side straight segments, the ends of said wire being coupled to one another such that said straight segments are disposed in a cylindrical array about a longitudinal axis. The stent is initially disposed in an operative configuration whereby the stent has a first internal diameter, and wherein the straight segments are generally parallel to one another. The stent is foldable or compressible to a contract configuration wherein the stent has an outer diameter or outer cross sectional dimension which is smaller than the first inner diameter of the operatively configured stent. The stent is formed of resilient material such that the stent is biased to, and will automatically self-expand to, its operative configuration. The preferred deployment catheter comprises an elongate catheter body having a balloon mounted thereon. The stent is positioned on the deflated balloon and folded or compacted to its compact configuration. One or more breakable retainer sheaths are positioned about the stent to hold the stent in its compact configuration on the balloon. The stent-bearing balloon catheter is advanceable into an anatomical passageway. Thereafter, the balloon is inflated to cause the breakable sheaths to tear, thereby releasing the stent and allowing the stent to undergo in situ self-expansion to its operative configuration within the anatomical passageway.

Claims

1. A stent delivery system, said system comprising:

a self expanding stent device comprising;

i) an elongate wire member having first and second ends, a multiplicity of back and forth bends being formed in said wire member at spaced-apart locations, so as to form said wire member into a series of side-by-side straight segments, the first and second ends of said wire member being coupled to one another such that said straight segments are disposed in a cylindrical array around a longitudinal axis;

ii) said stent device being alternately configureable in an operative configuration wherein said straight segments are substantially parallel to one another and disposed in said cylindrical array about said longitudinal axis so as to define a central passageway extending longitudinally therethrough and having a first diameter; and

,

iii) a compact configuration wherein said straight segments are compacted such that said stent has an outer cross sectional dimension which is smaller than said first diameter;

iv) said wire member being formed on resilient material and biased to said operative configuration such that, when unrestrained, said stent device will automatically expand from its said compact configuration to its said operative configuration;

a deployment catheter for delivering said stent device into an anatomical passageway, said deployment catheter comprising; and

,

i) an elongate catheter body;

ii) an inflatable balloon positioned on said catheter body;

iii) an inflation lumen extending through said catheter body for passing inflation fluid into and out of said balloon; and

,

said stent device being positioned on said elongate catheter body with said inflatable balloon in its deflated state, such that said inflatable balloon in disposed within said stent device; and

,

a pair of retaining sheaths being formed about the opposite ends of the stent device and adjacent portions of the balloon, said retaining sheaths being tearable in response to the exertion of outward radial pressure by inflation of said balloon such that, when said balloon is inflated, said retaining sheaths will be torn and said stent device will be thereby released from engagement to said deployment catheter such that said stent may further self expand to its operative configuration without concurrent inflation of said balloon beyond that which is required to cause said balloon to exert outward pressure to tear said retaining sheaths.

2. The system of claim 1 wherein said retaining sheaths are each formed of perforated plastic which is shrunk about the ends of the stent device and portions of the balloon.

3. The system of device of claim 1 wherein said retaining sheaths are each formed of elastomeric material.

17. The method of claim 4 wherein the stent provided in step a) is the stent of claim 1.

4. A method for delivering a self-expanding stent to a placement site within an anatomical passageway, said method comprising the step of:

a) providing a self-expanding stent which has a first operative configuration, and which is compactable to a second compact configuration;

b) providing a deployment catheter comprising an elongate catheter body having an inflatable balloon positioned thereon;

c) positioning said stent upon the balloon of said deployment catheter and causing said stent to be compacted to its compact configuration;

d) positioning a breakable stent holding member around at least a portion of said stent to hold said stent in its compact configuration upon said balloon;

e) advancing said deployment catheter, with said stent positioned thereon, into said anatomical passageway, such that the stent becomes located at its intended placement site;

f) inflating the balloon sufficiently to cause the stent holding apparatus to be broken, thereby releasing the stent and allowing the stent to self-expand to its operative configuration;

g) deflating said balloon;

h) removing said deployment catheter from said anatomical passageway such that the stent remains operatively positioned within said anatomical passageway.

5. The method of claim 4 wherein step b) further comprises the step of wrapping the ends of the stent with the sheath material which will tear under pressure when the balloon is inflated, and step d) further comprises the step of causing the sheath material to tear as the balloon is inflated.

6. The method of claim 4 wherein step a) further comprises the step of selecting the size of the stent and the number of convolutions defined thereby such that the expansion of the self-expansion of the stent to its operative configuration causes the stent to radially engage the anatomical passageway in a manner wherein the straight segments of the stent are no more than 5°

out of parallel with one another.

7. The method of claim 4 wherein said method is carried out during an open surgical procedure and step b) further comprises the step of passing the balloon having the stent positioned thereupon through an incision which provides access into the anatomical passageway.

8. The method of claim 4 wherein said method is carried out by percutaneous insertion and step b) further comprises the step of passing the balloon having the stent positioned thereupon percutaneously through a tubular introducer and subsequently transluminally advancing said balloon into said anatomical passageway.

9. The method of claim 4 wherein said anatomical passageway comprises a blood vessel.

10. The method of claim 9 wherein said treatment site is an area of atherosclerotic plaque occlusion.

11. The method of claim 9 wherein said treatment site is a compressed area of said blood vessel.

12. The method of claim 4 wherein said method is carried out subsequent to an angioplasty at the treatment site.

13. The method of claim 12 wherein said method is carried out subsequent to a balloon dilation angioplasty at the treatment site.

14. The method of claim 12 wherein said method is carried out subsequent to an atherectomy procedure at the treatment site.

15. The method of claim 12 wherein said method is carried out subsequent to an ultrasonic ablation procedure at the treatment site.

16. The method of claim 12 wherein said method is carried out subsequent to a laser ablative procedure at the treatment site.

18. A stent delivery and placement system, said system comprising:

a) a stent delivery catheter comprising an elongate catheter body having a proximal end, a distal end, and

a radially enlargeable stent expander apparatus formed on said catheter body at a first location thereon;

said stent expander apparatus being initially disposed in a non-expanded state having a first outer diameter and being radially expandable to fully expanded state having a second outer diameter;

b) a self-expanding stent device mounted upon said stent expander apparatus of said delivery catheter, said stent device comprising a generally tubular article having a hollow inner passageway extending longitudinally therethrough;

said stent device being alternately configurable in

i) a radially compressed configuration wherein the internal passageway of stent has a diameter which is substantially the same as the first diameter of said expander apparatus when in it'"'"'s non-expanded state; and

,

ii) a fully expanded configuration wherein the inner/passageway said stent has a fully expanded diameter which is larger than said second diameter of said expander apparatus when in it'"'"'s fully expanded state;

said stent being resiliently biased to it'"'"'s fully expanded configuration such that, when unrestrained, said stent will self-expand to it'"'"'s fully expanded configuration;

c) at least one retaining apparatus attached to said catheter and in abutting contact with at least a portion of said stent to retain said stent in it'"'"'s radially compressed configuration, said retaining apparatus being constructed such that it'"'"'s abutting contact with said stent will be disrupted when said stent expander apparatus is expanded to its second diameter, thereby causing said stent to become unrestrained and allowing said stent to further self-expand to its fully expanded configuration, without further expansion of said stent expander apparatus beyond it'"'"'s second outer diameter.

19. The system of claim 18 wherein said self-expanding stent comprises a plurality of substantially straight wire segments disposed in a zig-zag configuration about a central longitudinal axis so as to form said generally cylindrical stent configuration having said hollow inner passageway extending longitudinally therethrough.

20. The system of claim 19 wherein said plurality of wire segments comprise resilient wire material which is formed to resiliently self-expand from said radially compressed configuration to said fully expanded configuration.

21. The system of claim 18 wherein said stent has opposite ends, and wherein said retaining apparatus comprises a pair of retaining sheaths disposed about the opposite ends of the stent, said retaining sheaths being anchored to portions of the delivery catheter body adjacent said opposite ends of said stent.

22. The system of claim 21 wherein said retaining sheaths have tearable regions formed therein such that, when said stent expander apparatus is expanded to it'"'"'s said second diameter, said retaining sheaths will tear, thereby releasing said stent and allowing said stent to self-expand to its fully expanded configuration while said retaining sheaths remain anchored to said delivery catheter body.

23. The system of claim 22 wherein said retaining sheaths are formed of plastic film, and wherein said tearable regions comprise perforations formed in said plastic film.

24. The system of claim 18 wherein said stent expander apparatus comprises a balloon, and wherein at least one balloon inflation lumen extends longitudinally through at least a portion of said catheter body to permit passage of inflation fluid into and out of said balloon.

25. The system of claim 24 wherein said stent delivery catheter has an outer surface, and wherein said balloon comprises a generally cylindrical balloon formed about the outer surface of said catheter body at said first location.

26. In a stent delivery and placement system of the type wherein a self-expanding stent is advanced, in a radially compressed configuration, into an anatomical passageway having a known diameter, and subsequently allowed to self-expand to a fully expanded configuration wherein the outer diameter of said stent is at least as large as the known diameter of said anatomical passageway such that said stent is thereby frictionally held in a fixed position within said anatomical passageway, the improvement comprising:

a stent delivering and releasing catheter upon which said stent is initially mounted, said catheter being usable to advance said stent to a desired location within said anatomical passageway and to thereafter release said stent so as to allow said stent to self-expand and frictionally engage said passageway, said stent delivery catheter comprising;

i) an elongate catheter body having a proximal end a distal end;

ii) a stent expander apparatus disposed on said elongate catheter body, said stent expander apparatus being initially disposed in a non-expanded state having a first outer diameter, and being subsequently radially expandable to a fully expanded state having a second outer diameter, said second outer diameter of said stent expander apparatus being larger than its said first outer diameter, but smaller than the known diameter of said anatomical passageway;

said stent being initially mounted, in it'"'"'s radially compressed configuration, upon the stent expander apparatus of said delivery catheter while said stent expander apparatus is in said non-expanded state; and

,

iii) at least one retaining apparatus attached to said catheter body in abutting contact with said stent to hold said stent in it'"'"'s radially compressed configuration, said retaining apparatus being constructed such that it will be disrupted when said stent expander apparatus is expanded from it'"'"'s first diameter to it'"'"'s second diameter, said disruption of the stent retaining apparatus thereby causing said stent to become unrestrained and allowing said stent to further self-expand to it'"'"'s fully expanded configuration in frictional engagement with said anatomical passageway, without further expansion of said stent expander apparatus beyond its second outer diameter.

27. The device of claim 26 wherein said stent expander apparatus comprises a balloon formed on said elongate catheter body, and a balloon inflation lumen extending longitudinally through at least a portion of said catheter body to permit passage of a balloon inflation fluid into and out of said balloon.

29. The device of claim 26 wherein said at least one retaining apparatus comprises a retaining sheath attached to said catheter body and extending about a portion of said stent to hold said stent in said radially compressed configuration upon said non-expanded stent expander apparatus, said sheath being disruptable by the expansion of said stent expander apparatus to it'"'"'s fully expanded state having said second outer diameter.

30. The device of claim 29 wherein said retainer sheath has a tearable region formed therein such that said sheath will tear when said stent expander apparatus is expanded to it'"'"'s fully expanded state, thereby releasing said stent to permit said stent to further self-expand to it'"'"'s fully expanded configuration.

28. The device of claim 35 wherein said elongate catheter body has an outer surface, and wherein said balloon comprises a cylindrical balloon formed at a first location about the outer surface of said catheter body.