Vascular dilatation device and method

• US 5,527,282 A
• Filed: 12/09/1994
• Issued: 06/18/1996
• Est. Priority Date: 12/09/1994
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Jerome Segal
• Inventors: Segal, Jerome
• Primary Examiner(s): McDermott, Corrine M.
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/353,558
• Time in Patent Office: 557 Days
• Field of Search: 604/96, 604/95, 604/103, 604/104, 604/105, 604/108, 604/107, 604/106, 604/109, 604/264, 604/280, 604/282, 604/53
• US Class Current: 604/104
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30448 using adhesives
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A vascular dilatation device for enlarging a flow passage in an obstruction in a vessel carrying flowing blood. A flexible cylindrical dilatation member is provided for placement in the obstruction and has first and second ends and an intermediate portion between the first and second ends with an interior flow passage extending therethrough having a diameter and a longitudinally extending central axis. The diameter of the flow passage is variable with movement of the first and second ends relative to each other along the longitudinally extending central axis from a contracted position to an expanded condition. The flexible cylindrical dilatation member is comprised of a plurality of flexible elongate elements each of which extends helically about the longitudinally extending central axis. First and second collars respectively engage the first and second ends of the flexible cylindrical dilatation member to retain the first and second ends in contracted positions. A mechanism is provided for causing relative axial movement of the first and second ends towards each other to cause an intermediate portion of the flexible cylindrical dilatation member to expand to form a rigid cylinder and thereby enlarge the obstruction spaces between the flexible elongate elements at the first and second ends so that blood in the vessel can continue to flow through said first and second ends and through the interior flow passage.

Claims

1. A vascular dilatation device for enlarging a flow passage in an obstruction in a vessel carrying flowing blood comprising a flexible cylindrical dilatation member for placement in the flow passage in the obstruction and having first and second ends and an intermediate portion between the first and second ends, said flexible cylindrical dilatation member also having an interior flow passage extending therethrough with a diameter and a longitudinally extending central axis, said diameter of said flow passage being variable with movement of the first and second ends relative to each other along the longitudinally extending central axis from a contracted position to an expanded condition, said flexible cylindrical dilatation member being comprised of a plurality of flexible elongate elements each of which extends helically about the longitudinally extending central axis, a plurality of said flexible elongate elements having a first common direction of rotation and being axially displaced relative to each other and crossing a further plurality of said flexible elongate elements also axially displaced relative to each other and having a second common direction of rotation opposite to that of the first direction of rotation to form a braided flexible cylindrical dilatation member with an intermediate portion having diamond-shaped interstices between the flexible elongate elements, the crossing of the flexible elongate elements occurring in an area of contact between the flexible elongate elements, first and second means respectively engaging said first end second ends of said flexible cylindrical dilatation member for retaining said first and second ends in contracted positions and means for causing relative axial movement of said first and second ends towards each other from an extended position and to a contracted position with the diamond-shaped interstices in the intermediate portions being very elongate in a direction parallel to the axis when in the extended position and very elongate in a direction perpendicular to the axis in the contracted position and to cause said intermediate portion of said flexible cylindrical dilatation member to expand to form e radially rigid cylinder end thereby enlarge the flow passage in the obstruction by causing the flexible elongate elements in an intermediate portion to move into close apposition to each other while maintaining a plurality of diamond-shaped interstices of relatively constant shape and size between the flexible elongate elements at the first and second ends so that blood in the vessel can continue to flow through said first and second ends and through the flow passage in the obstruction and through the interior flow passage of the flexible cylindrical dilatation member while the flexible cylindrical dilatation member is in engagement with and enlarging the obstruction in the vessel, said diamond-shaped interstices being elongate in directions parallel to the longitudinally extending central axis.

2. A vascular dilatation device for enlarging a flow passage in an obstruction in a vessel carrying flowing blood comprising a flexible cylindrical dilatation member for placement in the flow passage in the obstruction and having first and second ends and an intermediate portion between the first and second ends, said flexible cylindrical dilatation member also having an interior flow passage extending therethrough with a diameter and a longitudinally extending central axis, said diameter of said flow passage being variable with movement of the first and second ends relative to each other along the longitudinally extending central axis from a contracted position to an expanded condition, said flexible cylindrical dilatation member being comprised of a plurality of flexible elongate elements each of which extends helically about the longitudinally extending central axis, a plurality of said flexible elongate elements having a first common direction of rotation and being axially displaced relative to each other and crossing a further plurality of said flexible elongate elements also axially displaced relative to each other and having a second common direction of rotation opposite to that of the first direction of rotation to form a braided flexible cylindrical dilatation member with an intermediate portion having diamond-shaped interstices between the flexible elongate elements, the crossing of the flexible elongate elements occurring in an area of contact between the flexible elongate elements, first and second means respectively engaging said first and second ends of said flexible cylindrical dilatation member for retaining said first and second ends in contracted positions, means for causing relative axial movement of said first and second ends towards each other from an extended position and to a contracted position with the diamond-shaped interstices in the intermediate portions being very elongate in a direction parallel to the axis when in the extended position and very elongate in a direction perpendicular to the axis in the contracted position and to cause said intermediate portion of said flexible cylindrical dilatation member to expand to form a radially rigid cylinder and thereby enlarge the flow passage in the obstruction by causing the flexible elongate elements in an intermediate portion to move into close apposition to each other wile maintaining a plurality of interstices between the flexible elongate elements at the first and second ends so that blood in the vessel can continue to flow through said first and second ends and through the flow passage in the obstruction and through the interior flow passage of the flexible cylindrical dilatation member while the flexible cylindrical dilatation member is in engagement with and enlarging the obstruction in the vessel, the flexible cylindrical dilatation member having an exterior surface, and protective covering means carried by the flexible cylindrical dilatation member covering at least portions of the exterior surface of the flexible cylindrical dilatation member, said protective covering means being formed of an expandable contractible material.

3. A device as in claim 2 wherein said expandable contractible material of the protective covering means is bonded to the flexible elongate elements.

4. A device as in claim 2 wherein the proximal and distal extremities of the flexible cylindrical dilatation member remain uncovered by the protective covering means to permit blood flow through the interstices into and out of the interior flow passage during expansion of the flexible cylindrical dilatation member.

5. A device as in claim 2 wherein said expandable contractible material of the protective covering means is in the form of a tubular sleeve placed over the flexible cylindrical dilatation member.

6. A vascular dilatation device for enlarging a flow passage in an obstruction in a vessel carrying flowing blood comprising a flexible cylindrical dilatation member for placement in the flow passage in the obstruction and having first and second ends and an intermediate portion between the first and second ends, said flexible cylindrical dilatation member also having an interior flow passage extending therethrough with a diameter and a longitudinally extending central axis, said diameter of said flow passage being variable with movement of the first and second ends relative to each other along the longitudinally extending central axis from a contracted position to an expanded condition, said flexible cylindrical dilatation member being comprised of a plurality of flexible elongate elements each of which extends helically about the longitudinally extending central axis, a plurality of said flexible elongate elements having a first common direction of rotation and being axially displaced relative to each other and crossing a further plurality of said flexible elongate elements also axially displaced relative to each other and having a second common direction of rotation opposite to that of the first direction of rotation to form a braided flexible cylindrical dilatation member with an intermediate portion having diamond-shaped interstices between the flexible elongate elements, the crossing of the flexible elongate elements occurring in an area of contact between the flexible elongate elements, first and second means respectively engaging said first and second ends of said flexible cylindrical dilatation member for retaining said first and second ends in contracted positions, means for causing relative axial movement of said first and second ends towards each other from an extended position and to a contracted position with the diamond-shaped interstices in the intermediate portions being very elongate in a direction parallel to the axis when in the extended position and very elongate in a direction perpendicular to the axis in the contracted position and to cause said intermediate portion of said flexible cylindrical dilatation member to expand to form a radially rigid cylinder and thereby enlarge the flow passage in the obstruction by causing the flexible elongate elements in an intermediate portion to move into close apposition to each other while maintaining a plurality of interstices between the flexible elongate elements at the first and second ends so that blood in the vessel can continue to flow through said first and second ends and through the flow passage in the obstruction and through the interior flow passage of the flexible cylindrical dilatation member while the flexible cylindrical dilatation member is in engagement with and enlarging the obstruction in the vessel, said first and second means respectively engaging said first and second ends of said flexible cylindrical dilatation member including an outer flexible elongate tubular member having a flow passage therein and an inner flexible elongate tubular member having a flow passage therein, said inner flexible elongate tubular member being disposed slidably and coaxially within the flow passage of the outer flexible elongate tubular member.

7. A device as in claim 6 wherein said outer and inner flexible elongate tubular members are each provided with a distal extremity, means of securing the proximal extremity of the flexible cylindrical dilatation member to the distal extremity of the outer flexible elongate tubular member and means securing the distal extremity of the flexible cylindrical dilatation member to the distal extremity of the inner flexible elongate tubular member.

8. A vascular dilatation device for enlarging a flow passage in an obstruction in a vessel carrying flowing blood comprising a flexible cylindrical dilatation member for placement in the flow passage in the obstruction and having first and second ends and an intermediate portion between the first and second ends, said flexible cylindrical dilatation member also having an interior flow passage extending therethrough with a diameter and a longitudinally extending central axis, said diameter of said flow passage being variable with movement of the first and second ends relative to each other along the longitudinally extending central axis from a contracted position to an expanded condition, said flexible cylindrical dilatation member being comprised of a plurality of flexible elongate elements each of which extends helically about the longitudinally extending central axis, a plurality of said flexible elongate elements having a first common direction of rotation and being axially displaced relative to each other and crossing a further plurality of said flexible elongate elements also axially displaced relative to each other and having a second common direction of rotation opposite to that of the first direction of rotation to form a braided flexible cylindrical dilatation member with an intermediate portion having diamond-shaped interstices between the flexible elongate elements, the crossing of the flexible elongate elements occurring in an area of contact between the flexible elongate elements, first and second means respectively engaging said first and second ends of said flexible cylindrical dilatation member for retaining said first and second ends in contracted positions, means for causing relative axial movement of said first and second ends towards each other from an extended position and to a contracted position with the diamond-shaped interstices in the intermediate portions being very elongate in a direction parallel to the axis when in the extended position and very elongate in a direction perpendicular to the axis in the contracted position and to cause said intermediate portion of said flexible cylindrical dilatation member to expand to form a radially rigid cylinder and thereby enlarge the flow passage in the obstruction by causing the flexible elongate elements in an intermediate portion to move into close apposition to each other while maintaining a plurality of interstices between the flexible elongate elements at the first and second ends so that blood in the vessel can continue to flow through said first and second ends and through the flow passage in the obstruction and through the interior flow passage of the flexible cylindrical dilatation member while the flexible cylindrical dilatation member is in engagement with and enlarging the obstruction in the vessel and a guide wire disposed in the flow passage in the inner flexible elongate tubular member and being adapted to extend beyond the distal extremity of the inner flexible elongate tubular member.

9. A vascular dilatation device for enlarging a flow passage in an obstruction in a vessel carrying flowing blood comprising a flexible cylindrical dilatation member for placement in the flow passage in the obstruction and having first and second ends and an intermediate portion between the first and second ends, said flexible cylindrical dilatation member also having an interior flow passage extending therethrough with a diameter and a longitudinally extending central axis, said diameter of said flow passage being variable with movement of the first and second ends relative to each other along the longitudinally extending central axis from a contracted position to an expanded condition, said flexible cylindrical dilatation member being comprised of a plurality of flexible elongate elements each of which extends helically about the longitudinally extending central axis, a plurality of said flexible elongate elements having a first common direction of rotation and being axially displaced relative to each other and crossing a further plurality of said flexible elongate elements also axially displaced relative to each other and having a second common direction of rotation opposite to that of the first direction of rotation to form a braided flexible cylindrical dilatation member with an intermediate portion having diamond-shaped interstices between the flexible elongate elements, the crossing of the flexible elongate elements occurring in an area of contact between the flexible elongate elements, first and second means respectively engaging said first and second ends of said flexible cylindrical dilatation member for retaining said first and second ends in contracted position, means for causing relative axial movement of said first and second ends towards each other from an extended position and to a contracted position with the diamond-shaped interstices in the intermediate portions being very elongate in a direction parallel to the axis when in the extended position and very elongate in a direction perpendicular to the axis in the contracted position and to cause said intermediate portion of said flexible cylindrical dilatation member to expand to form a radially rigid cylinder and thereby enlarge the flow passage in the obstruction by causing the flexible elongate elements in an intermediate portion to move into close apposition to each other while maintaining a plurality of interstices between the flexible elongate elements at the first and second ends so that blood in the vessel can continue to flow through said first and second ends and through the flow passage in the obstruction and through the interior flow passage of the flexible cylindrical dilatation member while the flexible cylindrical dilatation member is in engagement with and enlarging the obstruction in the vessel, said outer and inner flexible elongate tubular members having sidewalls with holes therein, said outer and inner flexible elongate tubular members being movable to bring the holes into registration with each other, said guide wire extending through said holes.

10. A device as in claim 9 wherein said holes in the side walls of said inner and outer flexible elongate tubular members are positioned so that when the flexible cylindrical dilatation member is in the expanded position, the holes are in registration with each other.

11. A vascular dilatation device for enlarging a flow passage in an obstruction in a vessel carrying flowing blood and for use in making a rapid exchange comprising a flexible cylindrical dilatation member for placement in the flow passage in the obstruction and having first and second ends and an intermediate portion between the first and second ends, said flexible cylindrical dilatation member also having an interior flow passage extending therethrough with a diameter and a longitudinally extending central axis, said diameter of said flow passage being variable with movement of the first and second ends relative to each other along the longitudinally extending central axis from a contracted position to an expanded condition, said flexible cylindrical dilatation member being comprised of a plurality of flexible elongate elements each of which extends helically about the longitudinally extending central axis, a plurality of said flexible elongate elements having a first common direction of rotation and being axially displaced relative to each other and crossing a further plurality of said flexible elongate elements also axially displaced relative to each other and having a second common direction of rotation opposite to that of the first direction of rotation to form a braided flexible cylindrical dilatation member with an intermediate portion having diamond-shaped interstices between the flexible elongate elements, the crossing of the flexible elongate elements occurring in an area of contact between the flexible elongate elements, first and second means respectively engaging said first and second ends of said flexible cylindrical dilatation member for retaining said first and second ends in contracted positions, means for causing relative axial movement of said first and second ends towards each other from an extended position and to a contracted position with the diamond-shaped interstices in the intermediate portions being very elongate in a direction parallel to the axis when in the extended position and very elongate in a direction perpendicular to the axis in the contracted position and to cause said intermediate portion of said flexible cylindrical dilatation member to expand to form a radially rigid cylinder and thereby enlarge the flow passage in the obstruction by causing the flexible elongate elements in an intermediate portion to move into close apposition to each other while maintaining a plurality of interstices between the flexible elongate elements at the first and second ends so that blood in the vessel can continue to flow through said first and second ends and through the flow passage in the obstruction and through the interior flow passage of the flexible cylindrical dilatation member while the flexible cylindrical dilatation member is in engagement with and enlarging the obstruction in the vessel, said means for causing relative axial movement of said first and second ends including an outer flexible elongate member having proximal and distal extremities and having a sidewall forming a lumen extending from the proximal extremity to the distal extremity, an inner flexible elongate member having proximal and distal extremities and having a sidewall forming a lumen extending from the proximal extremity to the distal extremity, said inner flexible elongate tubular member being slidably and coaxially mounted within the lumen of the outer flexible elongate tubular member, means securing the second end to the distal extremity of the inner flexible tubular member, means securing the first end to the distal extremity of the outer flexible elongate tubular member, said inner flexible elongate tubular member and said outer flexible elongate tubular member each having a port in the respective sidewall, means carried by the proximal extremities of the outer flexible elongate tubular member and the inner flexible elongate tubular member for moving said ports into registration with each other, a guide wire having a distal extremity, the distal extremity of the guide wire extending through the ports in registration with each other and into the lumen in the inner flexible elongate tubular member and being adapted to be moved to extend out of the distal extremity of the inner flexible elongate tubular member.

12. A vascular dilation device for enlarging a flow passage in an obstruction in a vessel carrying flowing blood, an outer flexible elongate tubular member having proximal and distal extremities and having a lumen extending from the proximal extremity to the distal extremity, an inner flexible elongate tubular member having proximal and distal extremities and having a lumen extending from the proximal extremity to the distal extremity, said inner flexible elongate tubular member being coaxially and slidably disposed in the lumen of the outer flexible elongate tubular member, a middle flexible elongate tubular member having proximal and distal extremities and having a lumen extending from the proximal extremity to the distal extremity, said middle flexible elongate tubular member being disposed between the inner flexible elongate tubular member and the outer flexible elongate tubular member, an expandable cylindrical dilatation member capable of being disposed in the flow passage in the obstruction and having proximal and distal extremities, means releasably securing the proximal extremity of the flexible cylindrical dilatation member between the distal extremities of the outer and middle flexible elongate tubular members, means releasably retaining the distal extremity of the flexible cylindrical dilatation member on the distal extremity of the inner flexible elongate tubular member and means carried by the proximal extremities of the outer, inner and middle flexible elongate tubular members for causing relative axial movement of the same for causing the proximal and distal extremities of the flexible cylindrical dilatation member to be released.

13. A device as in claim 12 together with a guide wire disposed in the lumen of the inner flexible elongate tubular member.

14. A device as in claim 12 wherein said cylindrical member is in the form of a self-expanding stent.

15. A method for enlarging a flow passage extending through an obstruction in a vessel carrying flowing blood by the use of an expandable flexible cylindrical dilatation member movable between contracted and expanded positions, moving the expandable flexible cylindrical dilatation member into the flow passage in the obstruction while it is in a contracted position, expanding the flexible cylindrical dilatation member by increasing its radial rigidity to enlarge the flow passage in the obstruction in the vessel while permitting blood to flow through the expandable flexible cylindrical dilatation member during the time the expandable flexible cylindrical dilatation member is in an expanded condition to thereby maintain blood flow in the vessel.

16. A method as in claim 15 together with the step of leaving the cylindrical member in the obstruction to maintain the enlarged passage in the obstruction.

17. A method as in claim 15 together with the step of delivering a drug to the vessel distal of the obstruction and to the vessel in the vicinity of the obstruction.

18. A method as in claim 15 together with the step of contracting the expandable flexible cylindrical dilatation member and withdrawing the expandable flexible cylindrical dilatation member from the obstruction.