Temporary stent and methods for use and manufacture

• US 5,222,971 A
• Filed: 10/09/1990
• Issued: 06/29/1993
• Est. Priority Date: 10/09/1990
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Schmaltz, Dale F., Willard, Lloyd
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US07/594,121
• Time in Patent Office: 994 Days
• Field of Search: 606/191, 606/192, 606/194, 606/195, 606/196, 606/197, 606/198, 604/95-106, 128/898, 623/1, 623/12
• US Class Current: 606/198
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/30672 temporary
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A temporary stent for supporting a region of a vessel in a body comprising a stent portion and an actuator portion and methods for the use and manufacture thereof. The stent portion is comprised of an elongate perfusable vessel supporting portion adapted to be configurable between a reduced size for placement in the vessel and removal therefrom and an expanded size for structurally supporting the vessel and perfusable end portions connected to and forming ends of the vessel supporting portion and adapted to allow fluid flow therethrough. The actuator portion includes a proximal end extending out of the body and a distal end connected to the stent portion and operable by manipulation at the proximal end thereof to configure the support portion into a reduced size and an expanded size.

Claims

1. A removable stent for temporarily supporting a region of a vessel in a body comprising:

a stent portion comprised of;

an elongate perfusable vessel supporting portion adapted to be configurable between a reduced size for placement in the vessel and removal therefrom and an expanded size for structurally supporting the vessel in the region; and

perfusable end portions connected to and forming ends of said vessel supporting portion and adapted to allow fluid flow therethrough,

and further in which said stent portion is comprised of a plurality of helically wound flat wires forming an elongate hollow tube in which the cross sectional dimension of the flat wires in the radial direction is less than the cross sectional dimension of the flat wires in the tangential direction; and

an actuator portion having a proximal end extending out of the body and a distal end connected to said stent portion and operable by manipulation at said proximal end to configure said support portion into said reduced size and said expanded size.

2. The temporary stent of claim 1 in which the elongate hollow tube of said stent portion comprises:

a proximal end and a distal end and further in which movement of said distal end toward said proximal end causes expansion of the diameter of said hollow tube and movement of said proximal end away from said distal end causes contraction of the diameter of the hollow tube.

3. The temporary stent of claim 2 in which said actuator portion comprises:

a first elongate member comprising an elongate catheter tube connected to said proximal end of said stent portion, and

a second elongate member slidably disposed in a lumen of said first elongate member and extending to and operable to move said distal end of said stent portion with respect to said proximal end of said stent portion.

4. The stent of claim 3 in which said elongate catheter tube comprises:

an outer tubular layer, and

an inner tubular layer concentric with said outer tubular layer.

5. The stent of claim 4 in which a distal end of said inner tubular layer terminates proximally from the distal end of said outer tubular layer and further in which said outer tubular layer has a reduced diameter distally from the distal end of said inner tubular layer.

6. The stent of claim 3 in which said second elongate member further comprises:

a guidewire tip extending distally from the distal end of said stent portion.

7. The stent of claim 6 in which said second elongate member is connected to the distal end of said stent portion.

8. The stent of claim 6 in which said second elongate member is slidingly received in the distal end of said stent portion and further in which said second elongate member comprises:

a first bearing portion operable to move said distal end of said stent portion distally; and

a second bearing portion operable to move said distal end of said stent portion proximally.

9. The stent of claim 6 in which said plurality of helically wound wires when said stent portion is in said expanded size comprise:

a proximal tapered region connected to said first elongate member;

and a distal tapered region connected to said second elongate member and further in which said plurality of helically wound wires forming the stent portion in said proximal tapered region and said distal tapered region are spaced apart from wires adjacent thereto to provide relatively large openings through said proximal and said distal tapered regions to facilitate blood flow therethrough.

10. The stent of claim 1 in which said plurality of wires are comprised of stainless steel wires.

11. The stent of claim 1 in which said stent portion comprises at least in part a fluoroscopic detectable material.

12. The stent of claim 11 in which said fluoroscopic detectable material is selected from a group consisting of:

gold, tantalum, platinum, tungsten and tungsten-iridium alloy.

13. The stent of claim 1 in which said second elongate member comprises:

an inner catheter member having a lumen therewithin extending from a proximal end of said inner catheter member to an opening at the distal end of said inner catheter member.

14. The stent of claim 13 in which said second inner catheter member is dimensioned so that fluids may be introduced to the distal end of said first elongate member via the lumen of said first elongate member in which said second catheter member is located.

15. The stent of claim 1 in which said actuator portion comprises at least in part a fluoroscopic detectable material.

16. The stent of claim 15 further comprising:

at least one band composed of a fluoroscopically detectable material connected to said actuator portion.

17. The stent of claim 16 in which said coating is selected from a group consisting of urokinase, heparin, albumen protein and antithrombin III.

18. The stent of claim 1 in which said stent portion is comprised at least in part of a material having non-thrombogenic properties.

19. The stent of claim 18 in which said stent portion includes a coating of a material comprising a slow release non-thrombogenic polymer.

20. The stent of claim 18 further comprising a DC source having a lead connected to said stent portion and another lead connectable to a patient'"'"'s body.

21. A method of temporarily implanting a stent into a region of the vascular system of a patient comprising the steps of:

advancing an expandable stent portion of the stent to the region,

operating an actuator portion comprised of a first elongate member having an outer catheter member connected to a proximal end of the stent portion and a second elongate member comprising a tubular member connected to a distal end of the stent portion by moving a proximal end of the first elongate member with respect to a proximal end of the second elongate member to cause expansion of the stent portion by moving a proximal end of the stent portion relatively to a distal end of the stent portion relatively to a distal end of the stent portion to effect expansion of a diameter of the stent,

supporting the region of the vascular system with the stent portion and allowing perfusion through the stent portion while in the stent portion is in an expanded configuration,

operating an actuator portion to cause contraction of the stent portion, and

withdrawing the stent portion.

22. The method of claim 21 in which the second elongate member comprises an inner catheter member having a lumen therein and further comprising the steps of:

positioning a guidewire in the vascular system of the patient to the region to be supported by the stent,

advancing the stent portion, the outer catheter member, and the inner catheter member into the region of the vascular system over the guidewire through the lumen in the inner catheter member.

23. The method of claim 22 further comprising the step of:

introducing fluids to the vascular system via the lumen of the inner catheter member.

24. The method of claim 22 further comprising the step of:

introducing fluids to the vascular system via a lumen of the outer catheter member.

25. The method of claim 21 further comprising the steps of:

positioning a delivery catheter into the patient to the region of the vascular system of the patient; and

advancing the stent portion and the actuator portion to the region of the vascular system through a lumen in the delivery catheter.

26. The method of claim 21 further comprising the steps of:

connecting a lead of a voltage source to the stent portion,

connecting another lead to the body of the patient, and

applying a potential between the leads to minimize the tendency for clotting materials to form on the stent portion.

27. The method of claim 21 in which said stent portion has a length of approximately between 1.5 and 3.5 cm when in an expanded size.

28. The method of claim 27 in which said stent portion has a length of approximately between 2.5 and 5 cm when in a reduced size.

29. The method of claim 21 in which said stent portion has a length of approximately between 2.5 and 5 cm when in a reduced size.

30. The method of claim 29 in which said stent portion has a length of approximately between 1.5 and 3.5 cm when in an expanded size.

31. The method of claim 21 in which said stent portion is comprised a plurality of helically wound wires.

32. The method of claim 21 in which said stent portion in an expanded configuration has a ratio of length to diameter of between 3.75 and 17.5.

33. The method of claim 21 in which said stent portion in an expanded configuration has a ratio of length to diameter of greater than 3.75.

34. A removable stent for temporarily supporting a region of a vessel in a body comprising:

(a) a stent portion comprised of;

(1) an elongate perfusable vessel supporting portion adapted to be configurable between a reduced size for placement in the vessel and removal therefrom and an expanded size for structurally supporting the vessel in the region; and

(2) perfusable end portions connected to and forming ends of said vessel supporting portion and adapted to allow fluid flow therethrough; and

(b) an actuator portion having a proximal end extending out of the body and a distal end connected to said stent portion and operable by manipulation at said proximal end to configure said support portion into said reduced size and said expanded size and further in which said actuator portion comprises;

(1) a first elongate member comprising an elongate catheter tube connected to said proximal end of said stent portion, said elongate catheter tube comprised of;

(A) an outer tubular layer; and

(B) an outer tubular layer concentric with said outer tubular layer; and

(2) a second elongate member slidably disposed in a lumen of said first elongate member and extending to and operable to move said distal end of said stent position with respect to said proximal end of said stent portion.

35. The stent of claim 34 in which a distal end of said inner tubular layer terminates proximally from the distal end of said outer tubular layer and further in which said outer tubular layer has a reduced diameter distally from the distal end of said inner tubular layer.

36. The stent of claim 34 in which said stent portion is comprised a plurality of helically wound wires forming an elongate hollow tube.

37. The stent of claim 36 in which said plurality of helically wound wires when said stent portion is in said expanded size comprise:

a proximal tapered region connected to said first elongate member;

and a distal tapered region connected to said second elongate member and further in which said plurality of helically wound wires forming the stent portion in said proximal tapered region and said distal tapered region are spaced apart from wires adjacent thereto to provide relatively large openings through said proximal and said distal tapered regions to facilitate blood flow therethrough.

38. The stent of claim 34 in which said stent portion is comprised a plurality of helically wound flat wires forming an elongate hollow tube in which the cross sectional dimension of the flat wires in the radial direction is less than the cross sectional dimension of the flat wires in the tangential direction.

39. The stent of claim 34 in which said second elongate member comprises:

an inner catheter member having a lumen therewithin extending from a proximal end of said inner catheter member to an opening at the distal end of said inner catheter member.

40. The stent of claim 34 in which said second inner catheter member is dimensioned so that fluids may be introduced to the distal end of said first elongate member via the lumen of said first elongate member in which said second catheter member is located.

41. The stent of claim 34 in which said stent portion is comprised at least in part of a material having non-thrombogenic properties.

42. A method of temporarily implanting a stent into a region of the vascular system of a patient said stent comprised of an expandable stent portion and an actuator portion formed of an outer catheter member connected to a proximal end of the stent portion and an inner catheter member having a lumen therein connected to a distal end of the stent portion, said method comprising the steps of:

positioning a guidewire in the vascular system of the patient to the region to be supported by the stent,

advancing the expandable stent portion, the outer catheter member, and the inner catheter member of the stent to the region over the guidewire through the lumen in the inner catheter member, said stent portion having a generally cylindrical size when expanded for structurally supporting the vessel in the region,

operating the actuator portion to cause expansion of the stent portion by moving a proximal end of the outer catheter member with respect to a proximal end of the inner catheter member to move a proximal end of the stent portion relatively to a distal end of the stent portion to effect expansion of a diameter of the stent,

supporting the region of the vascular system with the stent portion and allowing perfusion through the stent portion while in the stent portion is in an expanded configuration,

operating the actuator portion to cause contraction of the stent portion, and

withdrawing the stent portion.

43. The method of claim 42 further comprising the step of:

introducing fluids to the vascular system via the lumen of the inner catheter member.

44. The method of claim 42 further comprising the step of:

introducing fluids to the vascular system via a lumen of the outer catheter member.

45. A method of temporarily implanting a stent into a region of the vascular system of a patient comprising the steps of:

positioning a delivery catheter into the patient to the region of the vascular system of the patient; and

advancing the stent portion and the actuator portion to the region of the vascular system through a lumen in the delivery catheter, said stent portion having a generally cylindrical size when expanded for structurally supporting the vessel in the region,

operating an actuator portion to cause expansion of the stent portion,

supporting the region of the vascular system with the stent portion and allowing perfusion through the stent portion while in the stent portion is in an expanded configuration,

operating an actuator portion to cause contraction of the stent portion, and

withdrawing the stent portion.

46. A method of temporarily implanting a stent into a region of the vascular system of the patient comprising the steps of:

advancing an expandable stent portion of the stent to the region, said stent portion having a generally cylindrical size when expanded for structurally supporting the vessel in the region,

operating an actuator portion to cause expansion of the stent portion,

supporting the region of the vascular system with the stent portion and allowing perfusion through the stent portion while in the stent portion is in an expanded configuration,

connecting a lead of a voltage source to the stent portion,

connecting another lead to the body of the patient, and

applying a potential between the leads to minimize the tendency for clotting materials to form on the stent portion,

operating an actuator portion to cause contraction of the stent portion, and

withdrawing the stent portion.