Device and method for partially occluding blood vessels using flow-through balloon

• US 6,143,015 A
• Filed: 11/18/1998
• Issued: 11/07/2000
• Est. Priority Date: 05/19/1997
• Status: Expired due to Term

• Current Assignee: Cardio Medical Solutions Incorporated
• Original Assignee: Cardio Medical Solutions Incorporated
• Inventors: Nobles, Anthony A.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Trinh, (Vikki) Hoa B.
• Application Number:
  US09/193,977
• Time in Patent Office: 720 Days
• Field of Search: 606/194, 606/192, 606/191, 604/101, 604/96, 604/95, 604/264, 604/280, 604/169, 604/170, 604/43, 604/45
• US Class Current: 606/194
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0059 temporary

Abstract

A device and method are disclosed for partially occluding a blood vessel such that an area of hemostasis within the blood vessel is created without interrupting the blood flow through the blood vessel. The device comprises a first and second occlusive members for partially occluding a blood vessel, spaced apart from one another, wherein the occlusive members are inflatable to at least the inner diameter of the blood vessel. A tubular connector interconnects the first and second occlusive members and forms a conduit which allows the blood to flow through. When the occlusive members are inflated, an area of hemostasis is created between an outer surface of the tubular connector and an inner wall of the blood vessel while blood continues to flow through the tubular portion. A tube adapted to extend through an opening in the blood vessel to deploy the device includes multiple lumens, such as an inflation lumen to inflate the device and a suture lumen to collapse the device.

Claims

1. An apparatus for use in a blood vessel, comprising:

an occlusive device which comprises first and second inflatable occlusive members for partially occluding a blood vessel, said occlusive members spaced apart from each other, and a tubular connector having a diameter less than that of said occlusive members and extending between said occlusive members, wherein inflation of said occlusive members creates a region of hemostasis between an outer surface of said tubular connector and an inner wall of the blood vessel while permitting blood to flow through said tubular connector, and wherein said occlusive members comprise respective balloons of a material having sufficiently low compliance to limit axial lengthening of said balloons such that the axial length (L) of each balloon where the balloon contacts the vessel wall is no more than 50% of the diameter of the balloon when the balloon is inflated to create said region of hemostasis.

2. The apparatus of claim 1, wherein said occlusive members and said tubular connector are of a single piece construction comprised of a single material.

3. The apparatus of claim 1, wherein said low compliance material stretches by no more than 10-20% upon inflation.

4. The apparatus of claim 3, wherein said occlusive members are provided with pairs of internal ribs that interconnect the walls of said occlusive members to impede the longitudinal expansion of said occlusive members during inflation.

5. The apparatus of claim 1, wherein said tubular connector is comprised of inner and outer tubular portions, the apparatus comprising an inflation tube, a portion of which is disposed between said tubular portions.

6. An apparatus for use in a blood vessel, comprising:

a single piece of material configured to form first and second occlusive members with a tubular connector therebetween, said occlusive members allowing blood to flow through said tubular connector when said occlusive members are inflated to a diameter approximately equal to said blood vessel, said tubular connector having a diameter less the diameter of the blood vessel when said occlusive members are inflated to said diameter approximately equal to the blood vessel, wherein inflation of said occlusive members creates a region of hemostasis between an outer surface of said tubular connector and an inner wall of the blood vessel while blood flows through the tubular connector.

7. The apparatus of claim 6, wherein said material is expandable upon inflation to increase the diameter of the occlusive members by no more than 20%, such that said occlusive members have an unexpanded diameter which is at least 80% of the diameter of the vessel.

8. A surgical method, comprising:

forming an incision in the aorta of a patient;

inserting an occlusive device through the incision into the aorta; and

utilizing the occlusive device to create an area of hemostasis without interrupting blood flow through the aorta, said utilizing comprising positioning the occlusive device at a selected location in the aorta and activating the occlusive device after said device is positioned by pressurizing an inflation tube connected to the occlusive device.

9. The method of claim 8, wherein said positioning comprises using a marker on said inflation tube to determine the position of the device within the aorta.

10. The method of claim 8, further comprising positioning a marker along an outer surface of the aorta to indicate a position of the occlusive device within the aorta.

11. The method of claim 10, wherein the marker indicates a hemostasis zone, and the method further comprises surgically attaching a bypass graft to the aorta within the hemostasis zone.

12. A method of treating an aneurysm in a blood vessel, comprising:

inserting an occlusive device into the blood vessel; and

utilizing the occlusive device to create an area of hemostasis along the length of the aneurysm without interrupting blood flow through the blood vessel, said utilizing comprising positioning portions of said device on opposite sides of said aneurysm and activating said device.

13. A method of manufacturing an occlusive device, comprising:

providing a mandrel;

applying a low compliance biocompatible material to the mandrel;

removing the material from the mandrel as a single piece tubular structure; and

inserting one portion of said tubular structure inside another portion of said tubular structure to form a tubular structure with a double wall.

14. The method of claim 13, comprising inserting an inflation tube between the double wall.

15. An apparatus, comprising:

a tubular structure having first and second occlusive members connected by a tubular member, said tubular member configured to create an area of hemostasis in a blood vessel without interrupting blood flow through the vessel; and

a length of material attached to said tubular structure in a purse string arrangement such that force on said length of material collapses at least a portion of said tubular structure to facilitate removal of said structure from said blood vessel.

16. An apparatus comprising:

an occlusive device which comprises first and second inflatable occlusive members for partially occluding a blood vessel, said occlusive members spaced apart from each other, and a tubular connector having a diameter smaller than that of said occlusive members extending between said occlusive members, wherein inflation of said occlusive members creates an area of hemostasis between an outer surface of said tubular connector and an inner wall of the blood vessel while blood continues to flow through said tubular connector; and

an indicator marker which is adapted to be positioned along an outside surface of the blood vessel to indicate a position of the occlusive device within the blood vessel.

17. The apparatus of claim 16, wherein the indicator marker indicates working area which falls between said first and second occlusive members.

18. The apparatus of claim 16, further comprising a tube which is coupled to the occlusive device, said tube adapted to be used to directly introduce the occlusive device into a patient'"'"'s aorta.

19. The apparatus of claim 18, wherein said indicator marker is attached to said tube.

20. The apparatus of claim 19, wherein the indicator marker is removably attachable to said tube.

21. The apparatus of claim 16, wherein said first and second occlusive members and said tubular connector comprise separate, inflatable chambers.