Radially expandable intraluminal stent and delivery catheter therefore and method of using the same

• US 6,004,328 A
• Filed: 06/19/1997
• Issued: 12/21/1999
• Est. Priority Date: 06/19/1997
• Status: Expired due to Term

• Current Assignee: X Technologies, Inc. (Abbott Laboratories)
• Original Assignee: Ronald J. Solar
• Inventors: Solar, Ronald J.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US08/878,610
• Time in Patent Office: 915 Days
• Field of Search: 604/271, 606/108
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 25/0119 Eversible catheters

Abstract

As delivery catheter for a radially expandable intraluminal stent. The delivery catheter comprises an elongate outer tube defining proximal and distal ends and a lumen extending longitudinally therethrough. In addition to the outer tube, the delivery catheter includes an elongate inner tube defining proximal and distal ends and a guidewire lumen extending longitudinally therethrough. The inner tube is movably disposed within the lumen of the outer tube. The delivery catheter further includes a flexible deployment sleeve having a first end attached to the distal end of the outer tube, and a second end attached to the inner tube at a location proximal to the distal end thereof. The pressurization of the lumen of the outer tube with a fluid causes fluid pressure to be exerted on the sleeve in a manner facilitating the movement and the inner and outer tubes relative to each other such that a distal portion of the inner tube extending distally from the second end of the sleeve is deployed from the distal end of the outer tube.

Claims

1. A delivery catheter for delivering a radially expandable intraluminal apparatus to a desired location within a body lumen, said catheter comprising:

a) an outer tube having a proximal end, a distal end, and a lumen extending longitudinally therethrough;

b) an inner tube having a proximal end, a distal end, and a lumen extending longitudinally therethrough, said inner tube being disposed within the lumen of the outer tube, said inner tube having a distal portion upon which the intraluminal apparatus may be mounted; and

c) a flexible sleeve having a first end attached to a distal portion of the outer tube and a second end attached to the inner tube at a location which is proximal to said distal portion of said inner tube, said sleeve forming a substantially fluid-tight seal between said inner tube and said outer tube;

d) at least a portion of one of said inner and outer tubes being longitudinally moveable relative to the other thereof such that by changing the fluid pressure within the lumen of the outer tube, the delivery catheter will be caused to transition between;

i) a first configuration wherein the distal portion of the inner tube is surrounded laterally by the outer tube; and

ii) a second configuration wherein the distal portion of the inner tube is not surrounded laterally by said outer tube; and

e) a guidewire opening formed in the outer tube at a location between its proximal and distal ends, and the proximal end of the inner tube is affixed to the wall of the outer tube such that said guidewire opening leads to into the lumen of the inner tube, said inner tube thereby extending though only that portion of the lumen of the outer tube which extends from the guidewire opening to the distal end of the outer tube, and one of said inner and outer tubes being of variable length to facilitate the transitioning of the delivery catheter between its first configuration and its second configuration while the proximal end of the inner tube remains affixed to the wall of the outer tube.

2. The delivery catheter of claim 1 wherein said outer tube includes a radiopaque marker attached to the distal end thereof.

3. The delivery catheter of claim 2 wherein the first end of the sleeve is rigidly captured between said radiopaque marker and said outer tube.

4. The delivery catheter of claim 1 wherein the outer tube and the sleeve are made from one piece.

5. The delivery catheter of claim 1 wherein said inner tube includes a distal radiopaque marker attached to the distal end thereof and a proximal radiopaque marker attached thereto at a location proximal to the distal end thereof, the distal portion of the inner tube being defined between the distal and proximal radiopaque markers.

6. The delivery catheter of claim 5 wherein the second end of the sleeve is rigidly captured between the proximal radiopaque marker and the inner tube.

7. The delivery catheter of claim 1 further in combination with a self-expanding vascular stent positioned on the distal portion of the inner tube.

8. The delivery catheter of claim 1 further comprising an inflatable balloon disposed on the distal portion of the inner tube.

9. The delivery catheter of claim 8 further in combination with a pressure-expandable vascular stent positioned on the inflatable balloon.

10. The delivery catheter of claim 1 further comprising a proximal connector assembly attached to the proximal ends of the inner and outer tubes, said proximal connector assembly comprising:

a tubular outer body defining proximal and distal ends, the proximal end of the outer tube being attached to the distal end of the outer body;

a knob member rotatably connected to the proximal end of the outer body;

a tubular inner body defining proximal and distal ends, said inner body extending through the knob member and into the outer body, the proximal end of the inner tube being attached to the distal end of the inner body; and

an elastically deformable sealing member disposed between the inner and outer bodies;

said knob member being cooperatively engaged to the sealing member such that the rotation of the knob member in a first direction causes compressive pressure to be applied to the inner body by the sealing member which prevents the movement of the inner and outer tubes relative to each other, and the rotation of the knob member in a second direction opposite the first direction discontinues the application of the compressive pressure to the inner body by the sealing member which permits the movement of the inner and outer tubes relative to each other.

11. The delivery catheter of claim 10 wherein said outer body includes a tubular side arm portion which fluidly communicates with the lumen of the outer tube.

12. An over-the-wire embodiment of the delivery catheter of claim 1 wherein the inner tube extends substantially through the entire length of the outer tube and is axially moveable therewithin.

13. The delivery catheter of claim 1 wherein the variability in length of said at least one of said inner and outer tubes is by way of a collapsible segment formed therein.

14. The delivery catheter of claim 1 wherein the variability in length of said at least one of said inner and outer tubes is by way of a telescoping segment formed therein.

15. The delivery catheter of claim 1 wherein the outer tube is variable in length and the inner tube is of fixed length.

16. The delivery catheter of claim 15 further comprising a stiffening element which extends through said outer tube and which is attached to the outer tube such that pulling on the stiffening element in the proximal direction will assist the delivery catheter in transitioning from its first configuration to its second configuration.

17. A system comprising the delivery catheter of claim 16 in combination with an infusion pump/retractor apparatus, said infusion pump/retractor apparatus being connected to the lumen of the outer tube and to said stiffening element and being operative to infuse inflation fluid into the lumen of the outer tube while concurrently exerting proximally directed pulling force on the stiffening element, thereby causing the delivery catheter to transition from its first configuration to its second configuration.

18. The system of claim 17 wherein the infusion pump/retractor apparatus comprises:

a housing having a hollow bore extending longitudinally therethrough, said bore being defined by an inner housing surface;

a fluid outlet opening formed in said housing and coupled to the lumen of the outer tube of said delivery catheter such that fluid contained within the bore of the housing may be expelled through said fluid outlet opening and into the lumen of the outer tube;

a first set of threads formed on the inner housing surface of said housing;

a plunger received within the bore of said housing, said plunger having a sealing member which is in substantially fluid tight sealing contact with the inner housing surface, said plunger being longitudinally moveable within said housing such that when said plunger is advanced in the distal direction fluid will be expelled through the fluid outlet opening into the lumen of the outer tube;

a second set of threads being formed on said plunger, said second set of threads being engaged with said first set of threads such that rotation of said plunger in a first direction will cause the plunger to advance distally within the bore of the housing;

a hollow passageway defined by an inner plunger surface and extending longitudinally through the plunger, said stiffening element extending at least part way into said hollow passageway;

a third set of threads formed on the inner plunger surface, said third set of threads being in a direction which is opposite to the direction of the first set of threads formed on said inner housing surface;

a fourth set of threads formed on said stiffening element, said fourth set of threads being engaged with the third set of threads formed on said inner plunger surface such that, as said plunger is rotated in said first direction, the stiffening element will be retracted in the proximal direction.

19. The system of claim 18 wherein said first, second, third and fourth sets of threads are configured relative to one another to cause the proximally directed retraction of the stiffening element to be coordinated with the infusion of fluid into the lumen of the outer tube, thereby facilitating smooth transitioning of the deliver catheter from its first configuration to its second configuration.

20. The delivery catheter of claim 1 wherein the inner tube is variable in length and the outer tube is of fixed length.

21. The delivery catheter of claim 1 further comprising a stiffening element which extends through the delivery catheter to prevent unwanted curvature of the catheter.

22. The delivery catheter of claim 21 wherein the stiffening element extends through the lumen of the outer tube.

23. The delivery catheter of claim 22 wherein the outer tube has a longitudinally collapsible segment formed therein and wherein the stiffening element is operative to prevent the outer tube from inadvertently bending in the region of said collapsible segment.

24. A method for implanting a radially expandable endoluminal apparatus at a desired site within a luminal anatomical structure within the body of a mammal, said method comprising the steps of:

(a) providing a delivery catheter which includes;

i.) an outer tube having a proximal end, a distal end, and a lumen extending longitudinally therethrough;

ii.) an inner tube having a proximal end, a distal end, and a lumen extending longitudinally therethough, said inner tube being disposed within the lumen of the outer tube;

iii.) a radially expandable endoluminal apparatus mounted in a radially nonexpandable state upon a distal portion of the inner tube;

iv.) a flexible sleeve having a first end attached to a distal portion of the outer tube and a second end attached to the inner tube at a location which is proximal to said distal portion of said inner tube, said sleeve forming a substantially fluid-tight seal between said inner tube and said outer tube;

v.) at least a portion of one of said inner and outer tubes being longitudinally moveable relative to the other thereof such that by changing the fluid pressure within the lumen of the outer tube, the delivery catheter will be caused to transition between;

a first configuration wherein the distal portion of the inner tube is surrounded laterally by the outer tube; and

a second configuration wherein the distal portion of the inner tube is not surrounded laterally by said outer tube; and

vi.) a guidewire opening formed in the outer tube at a location between its proximal and distal ends, and the proximal end of the inner tube is affixed to the wall of the outer tube such that said guidewire opening leads to into the lumen of the inner tube, said inner tube thereby extending though only that portion of the lumen of the outer tube which extends from the guidewire opening to the distal end of the outer tube, and one of said inner and outer tubes being of variable length to facilitate the transitioning of the delivery catheter between its first configuration and its second configuration while the proximal end of the inner tube remains affixed to the wall of the outer tube;

(b) inserting the delivery catheter disposed into the body, with the delivery catheter disposed in its first configuration, and advancing the delivery catheter to a position wherein the distal end of the outer tube is at a desired location relative to the site at which the endoluminal prosthesis is to be implanted;

(c) pressurizing the lumen of the outer tube with a fluid so as to cause the delivery catheter to transition from its first configuration to its second configuration;

(d) causing the endoluminal apparatus to expand radially into contact with the luminal anatomical structure and to separate from the delivery catheter; and

(e) removing the delivery catheter from the mammalian body while allowing the endoluminal apparatus to remain implanted therein.

25. The method of claim 24 wherein the radially expandable endoluminal apparatus is of a type which self-expands to its second configuration and is held in its non-expanded state by at least one restraining member while mounted on the distal portion of the inner tube, and wherein step (d) comprises removing said restraining member to allow said apparatus to self expand to its second configuration.

26. The method of claim 24 wherein said outer tube acts as a restraining member to prevent radial expansion of the apparatus while it is within the catheter, and wherein the transitioning of the delivery catheter to its second configuration in step (c) serves to remove the constraint of said restraining member from said apparatus such that the radial expansion of the apparatus in step (d) occurs without further volitional manipulation of the delivery catheter.

27. The method of claim 24 wherein the delivery catheter provided in step (a) further comprises at least one clip for holding the radially expandable endoluminal apparatus in its non-expanded state upon said inner tube, and wherein step (d) of the method comprises releasing said at least one clip so as to allow said apparatus to self-expand.

28. The method of claim 24 wherein the endoluminal apparatus is of the pressure-expandable type and wherein the delivery catheter provided in step (a) further comprises a pressure exerting member for applying outwardly directed radial pressure against said endoluminal apparatus to radially expand said endoluminal apparatus, and wherein step (d) comprises utilizing said pressure exerting member to cause radial expansion of said endoluminal apparatus.

29. The method of claim 28 wherein said pressure exerting apparatus is a balloon positioned on the distal portion of the inner tube, beneath the endoluminal apparatus when said endoluminal apparatus is mounted on said distal portion of said inner tube, and wherein step (d) comprises inflating said balloon to cause radial expansion of said endoluminal apparatus.

30. The method of claim 24 wherein step (c) comprises causing the distal end of the outer tube to retract in the proximal direction.

31. The method of claim 24 wherein step (c) comprises causing the inner tube to extend out of and beyond the distal end of the outer tube.