Perfusion device for maintaining blood flow in a vessel while isolating an anastomosis

• US 5,769,870 A
• Filed: 02/20/1996
• Issued: 06/23/1998
• Est. Priority Date: 02/20/1996
• Status: Expired due to Term

• Current Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Original Assignee: Cardiothoracic Systems, Inc. (Boston Scientific Corporation)
• Inventors: Sepetka, Ivan, Taylor, Charles S., Matheny, Robert G., Salahieh, Amr, Cantu, Alfredo R.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Shai, Daphna
• Application Number:
  US08/603,415
• Time in Patent Office: 854 Days
• Field of Search: 606/108, 606/153, 606/191, 606/192, 606/194, 606/198, 623/1, 623/12
• US Class Current: 606/198
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site

Abstract

A plurality of embodiments of a distal perfusion device are disclosed, which device facilitates anastomosis constructions by maintaining a dry anastomosis site while simultaneously maintaining blood flow distally in the blood vessel to prevent ischemia and reduce overall patient trauma. The perfusion device is configured for installation into a blood vessel such as a left anterior descending coronary artery through an incision therein, to which is to be grafted a distal end of a blood vessel such as an internal mammary artery. The device includes a central member of selected configuration and material, terminating at either end thereof in respective selectively tapered end members. A lumen extending through the central member and end members, and selected perforations in the end members, maintain blood flow through the perfusion device. A selected portion or portions of the device'"'"'s outer circumference fit snugly within the artery in the regions beyond and/or at the anastomosis site, to maintain the latter free of blood. Several methods for deploying and removing respective embodiments of the device also are illustrated.

Claims

1. A distal perfusion device for maintaining blood flow in a blood vessel to prevent ischemia while further maintaining a dry anastomosis site to facilitate the suturing procedure during the construction of an anastomosis comprising:

a flexible central member having and outer diameter and having a centrally disposed lumen for the passage of fluid and a pair of pointed and tapered end members formed at proximal and distal extremities of the central member having integrally formed now-inflatable annular ridges with pre-selected outer diameters greater than the outer diameter of said central member and at least one perforation for the passage of fluid therethrough.

2. The distal perfusion device of claim 1 further comprised of a filamentary strand attached to the central member.

3. The distal perfusion device of claim 2 wherein said strand comprises two diverging strands attached to the central member at spaced-apart points to facilitate insertion of the device into the vessel.

4. The distal perfusion device of claim 2 further comprising a choker tube or stub.

5. The distal perfusion device of claim 4 wherein the choker tube or stub is integrally secured to the central member by said filamentary strand wherein said filamentary strand extends through said choker tube.

6. The distal perfusion device of claim 2 wherein a portion of said strand is embedded within the wall and along the length of the central members such that when a pulling force is applied to said strand, the central member is caused to separate along its length.

7. The distal perfusion device of claim 1 wherein the relative geometry of the end members is asymmetrical.

8. The distal perfusion device of claim 1 wherein the end members are each tapered to a smaller diameter from a point of attachment to the central member.

9. The distal perfusion device of claim 1 wherein the central member is comprised of a flexible coil.

10. The distal perfusion device of claim 9 wherein the device is comprised of a material selected from the group consisting of silicone, an elastomer material, a polymer material, and a polymer elastomer.

11. The distal perfusion device of claim 1 wherein the apex of each said tapered end member is closed.

12. The distal perfusion device of claim 1 wherein said central member comprises an expandable polymeric spiral.

13. The distal perfusion device of claim 1 wherein said central member comprises a necked-down section along a substantial portion of the length of the central member.

14. The distal perfusion device of claim 1 wherein each said tapered end member comprises one perforation generally coincident with the apex of said end member.

15. A method of employing a perfusion device at an anastomosis site in a vessel, comprising the steps of:

inserting a first tapered end member of the perfusion device through an arteriotomy, advancing the first end member into the vessel beyond the apex of the arteriotomy wherein the first end member has at least one annular ridge with a preselected diameter to engage the interior of the vessel, inserting a second tapered end member beyond the opposite apex of the arteriotomy such that the distal perfusion device is positioned coaxially within the vessel maintaining blood flow distally through the vessel while the perfusion device is in place.

16. The method of claim 15 further comprising the step of centering the perfusion device relative to the apexes of the arteriotomy such that the perfusion device spans the arteriotomy.

17. The method of claim 16 further comprising the step of:

removing the device with a thread attached to the central member.

18. The method of claim 15 wherein the perfusion device is flexed at a point along the central member to facilitate placing the second tapered end member into the arteriotomy and into place in the vessel.

19. The method of claim 15 further comprising sealing blood flow from the anastomosis using a suture surrounding the perfusion device and the vessel.

20. Apparatus for maintaining blood flow in a blood vessel to prevent ischemia while further maintaining a dry anastomosis site to facilitate the suturing procedure during the construction of an anastomosis of said vessel with a second vessel, comprising:

a selection of distinctly sized distal perfusion devices, each said device comprising a flexible central member having an outer diameter and having a centrally disposed lumen and a pair of pointed and tapered end members formed at the proximal and distal extremities of the central member, wherein said end members of each of said devices has integrally formed now-inflatable annular ridges with preselected outer diameters greater than the outer diameter of said central member and at least one perforation for the passage of fluid therethrough.

21. The apparatus of claim 20 wherein said preselected diameters of said integrally formed annular ridges differ among said selection of distinctly sized distal perfusion devices.

22. The apparatus of claim 21 wherein the relative geometry of the end members is asymmetrical.