Device and method for assisting end-to-side anastomosis

• US 5,944,730 A
• Filed: 03/06/1998
• Issued: 08/31/1999
• 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., Baladi, Naoum A.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Pham, Tina T. D.
• Application Number:
  US09/036,125
• Time in Patent Office: 543 Days
• Field of Search: 606/139, 606/213, 606/151, 606/191, 606/194, 606/198, 606/200, 606/158
• US Class Current: 606/151
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/0061 Implements located only on one side of the opening
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/0243 for immobilizing local areas of the heart, e.g. while it beats trocars attached to inner organs or inner body tissue A61B2017/3488
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065

Abstract

The present invention provides a device and method for creating a seal around the inner wall of an incision in a blood vessel. The device is particularly adapted to create an anastomosis site for coronary artery bypass grafts to a patient'"'"'s aorta without obstructing the flow of blood in the aorta. The device comprises an extruded tube with a translatable shaft positioned therein. One end of the shaft is coupled to a handle of the device which allows a practitioner to advance and withdraw the shaft relative to the tube. The other end of the shaft is connected to a flexible inverting member which is attached to the distal end of the tube. By manipulating the handle, the practitioner can remotely deform the inverting member between two configurations: an elongated, narrow configuration in which the inverting member is adapted to be inserted through a small incision, and an inverted configuration in which the inverting member forms an expanded, inward-facing cup. In operation, the medical practitioner inserts the inverting member into the blood vessel through an incision while the inverting member is maintained in its elongated, narrow configuration, and then manipulates the handle to cause the inverting member to assume its inverted configuration. A seal is then formed by applying a proximal force to the device to cause a rim of the cup to form a seal against an inner wall of the blood vessel. This prevents blood from flowing out of the incision and creates a working area for performing an end-to-side anastomosis. The working area is formed without interrupting the flow of blood through the vessel. The device preferably includes a hole punch device slidably mounted to the tube for allowing the practitioner to create an anastomosis hole once the seal has been formed.

Claims

1. A device for creating an anastomosis site along a wall of a blood vessel without interrupting the flow of blood through the blood vessel, the device comprising:

a first elongated member;

a second elongated member slidably mounted to the first elongated member; and

a deformable sealing member coupled to distal portions of the first and second elongated members, the sealing member being adjustable between;

an elongated, narrow configuration in which the sealing member is adapted to be inserted into and removed from the blood vessel through an incision in the wall of the blood vessel; and

an expanded configuration in which the sealing member has a rim which forms a seal against an inner wall of the blood vessel around the incision to create a region of hemostasis;

wherein the configuration of the sealing member is adjustable from the elongated configuration to the expanded configuration and vice versa by relative movement of the first and second elongated members from outside the blood vessel.

2. The device of claim 1, wherein the first elongated member is a tube and the second elongated member is a shaft which slides within the tube.

3. The device of claim 2, wherein the sealing member has a distal end which is attached to a distal end of the shaft, and has a proximal end which is attached to a distal end of the tube, and wherein the shaft extends through a hollow conduit of the tube.

4. The device of claim 3, wherein the sealing member inverts to form a cup when the distal end of the shaft and the distal end of the tube are moved relative to one another.

5. The device of claim 1, further comprising a handle that is operatively coupled to the first and second elongated members to allow a practitioner to remotely adjust the configuration of the sealing member.

6. The device of claim 5, wherein the handle comprises a trigger which is adapted to be actuated by the practitioner to cause the sealing member to automatically transform from the elongated configuration to the expanded configuration under the control of at least one spring.

7. The device of claim 1, wherein the sealing member comprises a flexible tubular member which expands radially when the sealing member is transformed from the elongated configuration to the expanded configuration.

8. The device of claim 7, wherein the flexible tubular member comprises a mesh tubing that is at least partially coated with a flexible, impermeable material.

9. The device of claim 7, wherein the mesh tubing is preformed to assume the expanded configuration.

10. The device of claim 7, wherein the flexible tubular member is transformed from the elongated configuration to the expanded configuration by inverting upon itself.

11. The device of claim 1, wherein the sealing member is of sufficient size to provide a working area along a wall of the blood vessel for performing an end-to-side anastomosis procedure.

12. The device of claim 1, wherein the sealing member is of sufficient size to provide a working area along a wall of a human aorta for performing a cardiac bypass procedure.

13. The device of claim 1, further comprising locking means for controllably locking the first and second elongated members together to maintain the sealing member in a particular configuration.

14. A method of forming an anastomosis site along the wall of a blood vessel without interrupting the flow of blood through the blood vessel, the method comprising:

advancing a flexible sealing member through an incision in a wall of the blood vessel with the sealing member maintained in an elongated configuration, the sealing member coupled to first and second elongated members which are slidably mounted to one another;

slidably moving the first and second elongated members relative to one another from outside the blood vessel to cause the sealing member to change configuration within the blood vessel;

withdrawing at least one of the first and second members proximally to cause a rim portion of the sealing member to form a seal against an inner surface of the blood vessel wall around the incision, to thereby form a pocket in which no blood flows; and

forming an anastomosis hole in the blood vessel wall within a boundary of the seal while blood flows through the blood vessel.

15. The method of claim 14, wherein the step of slidably moving the first and second elongated members comprises actuating a release to cause respective distal ends of the first and second elongated members to move toward one another under the force of a spring.

16. The method of claim 15, wherein the sealing member comprises a tubular member which extends between respective distal ends of the first and second elongated members, and wherein the step of slidably moving causes the tubular member to expand radially and invert upon itself.

17. The method of claim 14, further comprising the step of loosely suturing one end of a bypass graft to the blood vessel around the anastomosis hole with the sealing member positioned within the blood vessel and forming the seal.

18. The method of claim 14, further comprising the steps of:

slidably moving the first and second elongated members relative to one another from outside the blood vessel to cause the sealing member to return to the elongated configuration; and

withdrawing the sealing member from the blood vessel through the anastomosis hole.