Vascular dilatation device and method

• US 5,695,469 A
• Filed: 12/08/1995
• Issued: 12/09/1997
• Est. Priority Date: 12/09/1994
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Jerome Segal
• Inventors: Segal, Jerome
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/569,579
• Time in Patent Office: 732 Days
• Field of Search: 604/104, 604/282, 604/53, 604/107, 604/106, 606/194
• 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 having first and second ends is placed in the flow passage in the obstruction. An intermediate portion lies between the first and second ends. The flexible cylindrical dilatation member also has an interior flow passage with a diameter and a longitudinally extending central axis extending therethrough. 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 to an expanded condition. A control mechanism causes relative axial movement between the first and second ends towards each other from an extended position to a contracted position. The control mechanism includes an inner flexible elongate tubular member between the first and second ends of the flexible cylindrical dilatation member. The inner flexible elongate tubular member is sufficiently rigid and causes elongation of the cylindrical dilatation member to decrease its diameter and to advance the cylindrical dilatation member through the obstruction in the vessel while preventing axial contraction of the cylindrical dilatation member.

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 position, said expanded position permitting blood to flow through the flexible cylindrical dilatation member and means for causing relative axial movement of said first and second ends towards each other from an extended position to a contracted position, said means for causing relative axial movement including an outer flexible elongate tubular member having proximal and distal extremities, said distal extremity of the outer flexible elongate tubular member being secured to the first end of said flexible cylindrical dilatation member and an inner flexible elongate tubular member having proximal and distal extremities and disposed between the first and second ends of the flexible cylindrical dilatation member, said distal extremity of the inner flexible elongate tubular member being secured to the second end of said flexible cylindrical dilatation member, said inner flexible elongate tubular member having sufficient rigidity for causing elongation of the cylindrical dilatation member so as to decrease its diameter and cause advancement of the cylindrical dilatation member through the obstruction in the vessel while preventing axial contraction of the cylindrical dilatation member.

2. A device as in claim 1 further including a coil spring carried by said inner flexible elongate tubular member, said coil spring having turns which are in apposition to each other.

3. A device as in claim 2 wherein said coil spring is embedded in the inner flexible elongate tubular member.

4. A device as in claim 2 further including a safety ribbon secured to the inner flexible elongate tubular member and serving to prevent elongation of the coil spring at the distal extremity of the inner flexible elongate tubular member.

5. A device as in claim 1 further including a braided member embedded in the inner flexible elongate tubular member.

6. A device as in claim 1 wherein said inner flexible elongate tubular member is formed of a plastic.

7. A device as in claim 1 for use with a guide wire wherein said inner flexible elongate tubular member has a lumen extending therethrough, said lumen being sized so that it is adapted to having the guide wire slidably mounted therein.

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 position, said expanded position permitting blood to flow through the flexible cylindrical dilatation member and means for causing relative axial movement of said first and second ends of the flexible cylindrical dilatation member towards each other from an extended position to a contracted position, said means for causing relative axial movement including an outer flexible elongate tubular member having proximal and distal extremities, said distal extremity of the outer flexible elongate tubular member being secured to the first end of said flexible cylindrical dilatation member and an inner flexible elongate tubular support member having proximal and distal extremities and disposed between the first and second ends of the flexible cylindrical dilatation member, said distal extremity of the inner flexible elongate tubular support member being secured to the second end of said flexible cylindrical dilatation member, said inner flexible elongate tubular support member extending from the proximal extremity of the outer flexible elongate tubular member to a location at least near the distal extremity of the outer flexible elongate tubular member, said inner flexible elongate tubular support member having sufficient rigidity for causing elongation of the cylindrical dilatation member so as to decrease its diameter and cause advancement of the cylindrical dilatation member through the obstruction in the vessel while preventing axial contraction of the cylindrical dilatation member, said inner flexible elongate tubular support member also providing increased pushability and torquability to the device.

9. A device as in claim 8 wherein said distal extremity of the inner flexible elongate tubular support member is coupled to the second end of the flexible cylindrical dilatation member.

10. A device as in claim 8 further including a coil spring carried by said inner flexible elongate tubular support member, said coil spring having turns which are in apposition to each other.

11. A device as in claim 8 further including a braided member embedded in the inner flexible elongate tubular support member.

12. 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 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 and means for causing relative axial movement of the first and second ends towards each other from an extended position of a decreased diameter to a contracted position of an increased diameter, said means including a relatively rigid flexible elongate tubular support member extending from near the proximal extremity of the outer flexible elongate tubular member to a region in the distal extremity of the outer flexible elongate tubular member, said flexible elongate tubular support member providing increased pushability and torquability to the device.

13. A device as in claim 12 wherein at least a portion of said flexible elongate tubular support member is formed of metal.

14. A device as in claim 12 wherein said flexible cylindrical dilatation member is in the form of a dilatation spring comprised of a plurality of flexible elongate elements extending helically about the longitudinally extending central axis and having first and second common directions of rotation to form a braid with cross-over points, said elements being formed with undulations therein disposed at the cross-over points to inhibit slipping movement of the flexible elements with respect to each other during contraction of the flexible cylindrical dilatation member to increase the radial forces being applied to the obstruction by the flexible cylindrical dilatation member during contraction of the flexible cylindrical dilatation member.

15. A device as in claim 14 wherein the undulations in each of the flexible elongate elements occurs at every other cross-over point.

16. A device as in claim 15 wherein the undulations in one of the flexible elongate elements having the same direction of rotation and the next adjacent flexible elongate element having the same direction of rotation and having undulations therein offset therein by one cross-over point.

17. A method for enlarging a flow passage extending through an obstruction in a vessel having an inner wall and 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 preventing contraction of the flexible cylindrical dilatation member, expanding the flexible cylindrical dilatation member by sufficiently increasing its radial rigidity to compress the obstruction against the inner wall of the vessel 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.