Temporary stent and methods for use and manufacture

• US 5,449,372 A
• Filed: 06/14/1991
• Issued: 09/12/1995
• Est. Priority Date: 10/09/1990
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Schmaltz, Dale F., Kostur, Gary, Walter, Larry, Holman, Thomas
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US07/715,164
• Time in Patent Office: 1,551 Days
• Field of Search: 606/191, 606/198, 606/200, 623/1, 623/12, 604/104-109, 604/95
• 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 2/9517 handle assemblies therefor
• 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 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/005 using adhesives
• 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
• CPC Class Codes: C25F 3/24 of iron or steel

Abstract

A temporary stent for supporting a region of a vessel in a body comprising a composite stent portion and an actuator portion and methods for the use and manufacture thereof. The composite 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 composite stent portion is comprised of a plurality of resilient metallic wires coated with a polymeric material to provide stability for both lifting and maintaining a vessel. A method is disclosed for deployment of the composite stent to maintain vessel patency during occurrence of an intimal flap, vasoconstriction or vasospasm.

Claims

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

a composite 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 composite stent portion is comprised of;

a plurality of wires forming an elongate hollow tubular braid, and

a coating applied to said tubular braid to limit relative translation of one of said plurality of wires with respect to another of said plurality of wires at a location in said braid at which the one of said plurality of wires crosses the other of said plurality of wires; 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 said stent portion is comprised of a first set of wires helically wound in a first direction and a second set of wires helically wound in a second direction such that when said vessel supporting portion is in said expanded size, the wires of said first set form acute angles with the wires of said second set.

3. The temporary stent of claim 1 in which said stent portion is comprised of a plurality of wound wires forming a braid having a pick count of less than 16.

4. The temporary stent of claim 1 in which said stent portion is comprised of a plurality of wound wires forming a braid having a pick count of 12.

5. The temporary stent of claim 1 in which said stent portion is comprised of a plurality of wound wires of a diameter of approximately 0.002 to 0.0025 inches.

6. The stent of claim 1 in which said composite stent portion is comprised of:

a plurality of helically wound wires forming an elongate hollow tube, and

a coating applied to the plurality of helically wound wires.

7. The stent of claim 6 in which said coating is formed of a high modulus, high elongation polymeric material.

8. The temporary stent of claim 7 in which said polymeric coating is an aliphatic polyurethane.

9. The temporary stent of claim 6 in which said polymeric material is selected from a group consisting of:

polyurethane and silicone.

10. The temporary stent of claim 6 in which said coating encapsulates and adheres to crossing points of said plurality of helically wound wires thereby allowing relative rotation of wires at said crossing points but preventing translation of the wires at said crossing points.

11. The temporary stent of claim 6 in which said coating is preferably applied to said plurality of helically wound wires after said plurality of wires has been treated to resume an expanded configuration.

12. The temporary stent of claim 6 in which said coating is less than approximately 0.002 inches in thickness.

13. 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 said expanded size having a larger diameter than said reduced size; and

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

and further in which said stent portion comprises a resilient material having a memory to assume said expanded size.

14. The temporary stent of claim 13 in which said stent portion is comprised of a plurality of wound wires of a material treatable to resume a desired configuration.

15. The temporary stent of claim 13 in which said stent portion is comprised of a plurality of wound wires of a treatable cobalt-chromium-nickel-molybdenum based alloy.

16. The temporary stent of claim 13 in which said stent portion is comprised of a plurality of wound wires selected from a group consisting of:

elgiloy and MP35N.

17. The temporary stent of claim 13 in which said stent portion comprises a plurality of wound wires of a metal formed to resiliently return to a configuration conforming to said expanded size.

18. 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

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, said actuator portion comprising;

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;

a first marker connected at approximately the distal end of said stent portion;

a second marker connected at approximately the proximal end of said stent portion, whereby the length of said stent portion can be determined by observation of said first and said second markers.

19. The temporary stent of claim 18 further including:

a third marker connected to said second elongate member in a portion corresponding to the stent portion, whereby the relative positions of said first and second elongate members and thereby the size of said vessel supporting portion can be determined by observation of the position of said third marker relative to said first and second markers.

20. The temporary stent of claim 19 in which said third marker is connected to said second elongate member at a location such that when said vessel supporting portion is in said expanded size said third marker is proximate to said second marker.

21. The temporary stent of claim 18 in which said markers are made of platinum with 10% iridium.

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

a composite 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

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, said actuator portion comprising;

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

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, and

a lubricous coating located between said second elongate member and said first elongate member.

23. The temporary stent of claim 22 in which said second elongate member further includes said lubricous coating on at least one surface thereof.

24. The temporary stent of claim 23 in which said lubricious coating is located on an inner surface of said second elongate member.

25. The temporary stent of claim 23 in which said lubricious coating is located on an outer surface of said second elongate member.

26. The temporary stent of claim 23 in which said lubricious coating is selected from a group consisting of:

a hydrophilic coating, paralyene, teflon, and silicone.

27. The temporary stent of claim 22 in which said first elongate member further includes said lubricous coating on at least one surface thereof.

28. The temporary stent of claim 27 in which said lubricious coating is located on an inner surface of said first elongate member.

29. The temporary stent of claim 27 in which said lubricious coating is located on an outer surface of said first elongate member.

30. The temporary stent of claim 27 in which said lubricious coating is selected from a group consisting of:

a hydrophilic coating, paralyene, teflon, and silicone.

31. A method of stabilizing a patient'"'"'s vessel during an occurrence or during a time when there is the potential for an occurrence of a restriction to blood flow through the vessel from a vasoconstriction, vasospasm, or similar condition at a location in the vessel, comprising the steps of:

positioning a temporary stent into the patient'"'"'s vessel with a vessel supporting portion of the temporary stent in the vessel at the location and an actuator portion of the temporary stent having a distal portion connected to the vessel supporting portion and a proximal portion extending out of the patient'"'"'s vessel;

manipulating the vessel supporting portion from the proximal portion of the actuator portion to cause the vessel supporting portion to change from a reduced size suitable for positioning of the temporary stent in the patient'"'"'s vessel to an expanded size suitable for supporting the patient'"'"'s vessel during an occurrence or during a time when there is the potential for an occurrence of a restriction to blood flow through the vessel from a vasoconstriction, vasospasm, or similar condition;

maintaining said vessel supporting portion in said expanded size while permitting blood perfusion through distal and proximal ends of the vessel supporting portion;

manipulating the vessel supporting portion from the proximal portion of the actuator portion to cause the vessel supporting portion to change from said expanded size to said a reduced size;

withdrawing the temporary stent after the condition or potential of a condition of a vasoconstriction, vasospasm, or similar condition has passed.

32. The method of claim 31 further comprising the step of:

during at least a portion of said vessel maintaining step, administering medicines from the proximal end of the actuator portion to a proximal portion of the vessel supporting portion via a lumen of an outer catheter member of the actuator portion.

33. The method of claim 32 in which the positioning step further comprises:

maintaining an outer catheter connected to a proximal end of the vessel supporting portion in tension with respect to an inner catheter located internally to said outer catheter and connected to a distal end of the vessel supporting portion to maintain said vessel supporting portion in the reduced size as the vessel supporting portion is advanced through the patient'"'"'s vascular system; and

in which the manipulating step further comprises;

reducing the tension maintained on the outer catheter so that said vessel supporting portion resumes an expanded size.

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

(a) a stent portion comprised of;

(i) 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

(ii) 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 wires forming an elongate hollow tubular braid,

and further in which relative translation of one of said plurality of wires with respect to another of said plurality of wires at locations in said braid at which one of said plurality of wires crosses another of said plurality of wires is limited; 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.

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

(a) a stent portion comprised of;

(i) 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

(ii) 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 wires forming an elongate hollow tubular braid having sufficient structural strength for supporting three radially compressive forces on the order of 120 grams in order to support the region of the vessel; 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 supporting portion into said reduced size and said expanded size.