Device and method for assisting end-to side anastomosis

• US 6,409,739 B1
• Filed: 05/01/1998
• Issued: 06/25/2002
• Est. Priority Date: 05/19/1997
• Status: Expired due to Term

• Current Assignee: Cardio Medical Solutions Incorporated
• Original Assignee: Cardio Medical Solutions Incorporated
• Inventors: Baladi, Naoum A., Nobles, Anthony A.
• Primary Examiner(s): Schaetzle, Kennedy
• Assistant Examiner(s): DROESCH, KRISTEN L
• Application Number:
  US09/071,462
• Time in Patent Office: 1,516 Days
• Field of Search: 606/151, 606/198, 606/200, 606/213-216, 606/191, 606/153, 606/206, 606/148-149, 606/157-158, 604/294
• US Class Current: 606/148
• 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
• 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

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 or, in an alternative embodiment, to advance and withdraw the tube relative to the shaft. 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 a seal around an incision in a blood vessel which allows blood to flow through the blood vessel, comprising:

a tube;

a shaft slidably mounted within said tube;

a retaining member which prevents relative movement between said shaft and said tube, said retaining member being releasable to allow said relative movement;

a deformable sealing member adjoining distal ends of said shaft and said tube, said sealing member being reversibly adjustable, between;

an elongated, narrow configuration for insertion of said sealing member through the incision; and

a sealing configuration in which (i) a first portion of said sealing member seals against an inner wall of the blood vessel, and (ii) a second portion of said sealing member, interior to said first portion, is spaced from the inner wall of the blood vessel to form a cavity which provides a region of hemostasis within the blood vessel;

wherein the configuration of said sealing member is changed by movement of said shaft relative to said tube.

2. The device of claim 1, wherein said sealing member comprises a preformed tubular member.

3. The device of claim 1, further comprising a handle that is operatively coupled to said tube and said shaft to allow a practitioner to remotely adjust the configuration of said sealing member.

4. The device of claim 2, said handle comprising a spring which when released urges said tube away from and distal to said handle and causes said sealing member to invert.

5. The device of claim 4, wherein said sealing member remains separated from the inner wall of the vessel while said sealing member is inverted.

6. The device of claim 4, wherein said sealing member is inverted by moving said tube.

7. The device of claim 4, wherein said tube is moved distally relative to said handle and said shaft to deploy said sealing member.

8. An apparatus, comprising:

first and second shafts; and

a sealing member comprising proximal and distal inverting members, said inverting members connected to said first and second shafts, respectively, such that a first relative movement of said shafts positions said proximal inverting member inside said distal inverting member, and a second relative movement of said shafts opposite to said first relative movement inverts said proximal inverting member to position said proximal inverting member outside said distal inverting member.

9. The apparatus of claim 8, wherein said distal inverting member has a substantially conical shape when said proximal inverting member is inside said distal inverting member, such that said sealing member forms a cavity.

10. The apparatus of claim 8, wherein said sealing member has a first position juxtaposed with one of said shafts and a second, expanded position sized to seal around an opening in tissue, and wherein said relative movement has a range of motion, one end of said range providing said first, juxtaposed position and another end of said range of motion providing said second, expanded position.

11. The apparatus of claim 8, wherein one of said shafts comprises a tube and the other of said shafts comprises a rod within said tube.

12. A method of occluding an opening into a blood vessel, comprising:

providing a pair of inverting members that are operably connected to a handle, each inverting member having an apex portion and a base portion, said base portions being attached to each other;

positioning said members so that said apex portions are spaced apart such that said members provide a narrow elongated configuration;

inserting said members into said opening in said elongated configuration;

positioning said members so that said apex portions of said members are adjacent to each other such that at least one of said members forms a cavity between its base portion and its apex portion;

positioning said inverting members so that said cavity provides a region of hemostasis around said opening within said blood vessel; and

withdrawing the handle away from the blood vessel such that the inverting members are removed from the blood vessel.

13. A method of creating a region of hemostatis in a blood vessel while allowing blood to flow in the vessel past the region of hemostatis, said method comprising:

providing a sealing member comprising a sleeve having a pair of ends and a portion intermediate the ends which (i) expands outwardly in response to movement of the ends of the sleeve towards each other and (ii) contracts inwardly in response to movement of the ends of the sleeve away from each other;

inserting the sealing member into the blood vessel with the ends of the sleeve sufficiently separated so that said sleeve is in an elongated, substantially unexpanded condition;

positioning the sealing member at a desired location in the blood vessel;

moving the ends of the sleeve towards each other to expand the intermediate portion such that the intermediate portion seals against an inner wall of the blood vessel for forming the region of hemostasis; and

removing the sealing member from the blood vessel.

14. A method of forming an anastomosis site along the wall of a blood vessel comprising:

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

moving the first and second members relative to one another from outside the blood vessel to cause the sealing member to deform to a cup having a rim; and

moving the sealing member proximally within the blood vessel to cause the rim to form a seal against an inner surface of the blood vessel wall, to thereby form a region of hemostasis within the blood vessel.

15. The method of claim 14, wherein the sealing member comprises a flexible member which interconnects the first and second members, and wherein the step of deforming the sealing member comprises actuating a handle which causes one of the members to be advanced distally while the other member is maintained stationary.

16. The method of claim 14, further comprising:

slidably advancing a hole punch device distally along at least one of the first and second members to the incision with the sealing member forming a seal; and

actuating the hole punch device to form an anastomosis opening in the wall of the blood vessel within a boundary of the seal.

17. A method of forming an anastomosis site, the method comprising:

accessing a blood vessel of a patient;

making an incision in a wall of the blood vessel and inserting a sealing member into the blood vessel with the sealing member maintained in an elongated, narrow configuration;

deforming the sealing member to form a cup;

applying tension to the cup through the incision to seal a rim of the cup to an interior surface of the blood vessel wall without interrupting the flow of blood through the blood vessel; and

advancing a suture through the wall of the blood vessel adjacent the rim of the cup while the sealing member is within the blood vessel.

18. A method of forming an anastomosis site, the method comprising:

accessing a blood vessel of a patient;

making an incision in a wall of the blood vessel and inserting a sealing member into the blood vessel with the sealing member maintained in an elongated, narrow configuration, wherein the sealing member comprises a flexible member which interconnects a distal end of a tube to a distal end of a shaft, the shaft slidably mounted within the tube;

deforming the sealing member to form a cup, wherein the step of deforming the sealing member comprises actuating a handle which causes the tube to be advanced distally over the shaft without moving the shaft; and

applying tension to the cup through the incision to seal a rim of the cup to an interior surface of the blood vessel wall without interrupting the flow of blood through the blood vessel.

19. A method of forming an anastomosis site, the method comprising:

accessing a blood vessel of a patient;

making an incision in a wall of the blood vessel and inserting a sealing member into the blood vessel with the sealing member maintained in an elongated, narrow configuration;

deforming the sealing member to form a cup, wherein the sealing member comprises a flexible member which interconnects a distal end of a tube to a distal end of a shaft, the shaft slidably mounted within the tube, and wherein the step of deforming the sealing member comprises actuating a handle which causes the tube to be advanced distally over the shaft without moving the shaft;

applying tension to the cup through the incision to seal a rim of the cup to an interior surface of the blood vessel wall without interrupting the flow of blood through the blood vessel;

slidably advancing a hole punch device distally along the tube to the incision with the sealing member forming a seal; and

actuating the hole punch device to form an anastomosis opening in the wall of the blood vessel.

20. A method of forming an anastomosis site, the method comprising:

accessing a blood vessel of a patient;

making an incision in a wall of the blood vessel and inserting a sealing member into the blood vessel with the sealing member maintained in an elongated, narrow configuration;

deforming the sealing member to form a cup;

applying tension to the cup through the incision to seal a rim of the cup to an interior surface of the blood vessel wall without interrupting the flow of blood through the blood vessel; and

attaching a tubular graft to said blood vessel, said attaching comprising (a) positioning edges of an end of the tubular graft so that the edges surround the incision, and (b) fastening the edges to the blood vessel such that the graft is sealed against the vessel.