Endoscopic cardioplegia infusion cannula and method of use

• US 5,980,503 A
• Filed: 04/08/1996
• Issued: 11/09/1999
• Est. Priority Date: 04/08/1996
• Status: Expired due to Fees

• Current Assignee: Guidant Corporation (Boston Scientific Corporation)
• Original Assignee: Guidant Corporation (Boston Scientific Corporation)
• Inventors: Chin, Albert K.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/629,042
• Time in Patent Office: 1,310 Days
• Field of Search: 604/49, 604/52-54, 604/96, 604/174, 604/175, 604/264, 604/280
• US Class Current: 604/509
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61M 2210/127 Aorta
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

An endoscopic cardioplegic infusion cannula and its method of use is provided for occluding the ascending aorta and infusing cardioplegic fluid into the coronary arteries. A cannula is inserted suprasternally and the distal end of the cannula is inserted into the ascending aorta. An occlusion balloon on the distal end of the cannula is inflated and occludes the ascending aorta. Cardioplegic fluid is infused through the cannula proximal to the occlusion balloon and perfused into the coronary arteries. In order to effect a better seal where the distal end of the cannula is inserted into the ascending aorta, an outer sheath having a flange is advanced over the cannula into contact with the ascending aorta to compress a portion of the ascending aorta between the flange and the occlusion balloon. Cardiopulmonary bypass is effected in a known manner to supply the patient with oxygenated blood. The cannula and its method of use can be used in a closed or open chest procedure. Sternal lifting is used in conjunction with the present invention to create a greater working space over the heart.

Claims

1. A method of inserting a cannula into the ascending aorta and infusing cardioplegic solution therein, the cannula having an elongated cannula body with an angled bend formed in a distal end thereof, an occlusion balloon positioned at the distal end of the elongated cannula body, and an outer sheath surrounding the elongated cannula body and dimensioned for axial movement there along, the method comprising:

inserting the elongated cannula body into a body cavity;

positioning the distal end of the elongated cannula body over the ascending aorta;

incising the aorta in the center of a pursestring suture previously formed in the ascending aorta;

inserting the distal end of the elongated cannula body into the ascending aorta and inflating the occlusion balloon therein;

drawing the pursestring suture around the elongated cannula body;

advancing the outer sheath until the distal end thereof is in contact with the ascending aorta thereby compressing a portion of the ascending aorta between the distal end of the outer sheath and the occlusion balloon; and

infusing a cardioplegic solution into the ascending aorta proximate to the occlusion balloon so that the cardioplegic solution perfuses into the coronary arteries.

2. The method of claim 1, wherein the sternum is lifted to create space above the ascending aorta.

3. The method of claim 2, wherein the sternum is lifted to create a working space over the heart and the ascending aorta.

4. The method of claim 1, wherein the outer sheath includes a flange at its distal end, the method further comprising advancing the outer sheath so that a portion of the ascending aorta is compressed between the flange contacting the outside of the ascending aorta and the occlusion balloon contacting the inside of the ascending aorta.

5. The method of claim 4, wherein the outer sheath is locked with respect to elongated cannula body so that the flange remains in contact with the outside of the ascending aorta thereby providing a seal where the cannula body enters the ascending aorta.

6. The method of claim 1, wherein the occlusion balloon is deflated after a medical procedure is performed.

7. The method of claim 6, wherein the elongated cannula body is removed from the ascending aorta and the incision is closed by drawing and tying the pursestring suture.

8. The method of claim 1, wherein the cannula is inserted suprasternally.

9. A method of closed-chest cannulation of the ascending aorta and infusing cardioplegic solution therein, including a cannula having an elongated cannula body with an angled bend formed in a distal end thereof, an occlusion balloon positioned at the distal end of the elongate cannula body, and an outer sheath surrounding the elongated cannula body and dimensioned for axial movement therealong, the method comprising:

lifting the sternum to create a space above the heart area;

providing a pursestring suture in the ascending aorta;

suprasternal insertion of the elongated cannula body and positioning the distal end of the cannula body above the ascending aorta;

incising the ascending aorta in the center of the pursestring suture;

inserting the distal end of the elongated cannula body into the ascending aorta;

drawing the pursestring suture around the elongated cannula body to create a seal and prevent leakage;

inflating the occlusion balloon in the ascending aorta;

advancing the outer sheath, which has a flange on its distal end, so that the flange is in contact with the outside of the ascending aorta, thereby compressing the ascending aorta between the flange and the occlusion balloon; and

infusing a cardioplegic solution into the ascending aorta proximate to the occlusion balloon so that the cardioplegic solution perfuses into the coronary arteries.

10. The method of claim 9, wherein the outer sheath is locked with respect to the elongated cannula body so that the flange remains in contact with the outside of the ascending aorta thereby providing a seal where the distal end of the cannula body enters the ascending aorta.

11. The method of claim 9, wherein the occlusion balloon is deflated after a medical procedure is performed.

12. The method of claim 9, wherein the elongated cannula body is removed from the ascending aorta and the incision is closed by drawing and tying the pursestring suture.

15. The cannula of claim 9, wherein the occlusion balloon is formed from an elastomeric material.

13. A cannula for insertion into the ascending aorta, comprising:

an elongated cannula body having a distal end and a proximal end;

an angled bend formed in the distal end of the elongated cannula body;

an occlusion balloon positioned at the distal end of the elongated cannula body; and

a sheath having a sufficiently flexible distal end for facilitating movement around an angle of varying degrees, a proximal end, and dimensioned to slidably advance and retract over the elongated cannula body so that when the distal end of the elongated cannula body is inserted into the ascending aorta the sheath can be advanced distally until a portion of the ascending aorta is positioned between the occlusion balloon and the distal end of the sheath.

14. The cannula of claim 13, wherein the occlusion balloon is dimensioned to occlude the ascending aorta.

16. The cannula of claim 13, wherein the elongated cannula body includes a port near the distal end of the elongated cannula body and an infusion lumen in fluid communication with the port for infusing cardioplegic solution upstream of the occlusion balloon and into the coronary arteries.

17. The cannula of claim 16, wherein the port is positioned proximate to the occlusion balloon so that after the occlusion balloon is inflated, cardioplegic solution is infused into the coronary arteries and the expanded balloon prevents the cardioplegic solution from entering the brachiocephalic and carotid arteries.

18. The cannula of claim 13, wherein the angled bend is an approximately 90°

bend relative to the elongated cannula body.

19. The cannula of claim 13, wherein the angled bend is in the range of 20°

to 150°

relative to the elongated cannula body.

20. The cannula of claim 13, wherein the elongated cannula body is formed from a rigid plastic.

21. The cannula of claim 13, wherein the elongated cannula body is formed from a metallic alloy taken from the group of metallic alloys including stainless steel and titantium.

22. The cannula of claim 13, wherein at least a portion of the elongated cannula body is formed from a polymeric material.

23. The cannula of claim 13, wherein the distal end of the elongated cannula body is tapered to facilitate entry of the cannula into the ascending aorta.

24. The cannula of claim 13, wherein the elongated cannula body is dimensioned for suprasternal insertion and extending to the ascending aorta.

25. The cannula of claim 13, wherein the elongated cannula body includes an inflation lumen for inflating the occlusion balloon.

26. A cannula for insertion into the ascending aorta, comprising:

an elongated cannula body having a distal end and a proximal end;

an angled bend formed in the distal end of the elongated cannula body;

an expandable member on the distal end of the elongated cannula body for occluding the ascending aorta; and

an outer sheath disposed over a portion of the elongated cannula body and dimensioned for sliding movement over the elongated cannula body, the outer sheath having a sufficiently flexible distal end for facilitating movement around an angle of varying degrees, a proximal end and a flange on the distal end so that when the distal end of the elongated cannula body is inserted into the ascending aorta, the outer sheath can be advanced until a portion of the ascending aorta is positioned between the expandable member and the flange on the outer sheath.

27. The cannula of claim 26, wherein the elongated cannula body includes a port near the distal end of the elongated cannula body and an infusion lumen in fluid communication with the port for infusing cardioplegic solution through the port and into the coronary arteries.

28. The cannula of claim 27, wherein the port is positioned proximate to the expandable member so that after the expandable member is inflated, cardioplegic solution is infused into the coronary arteries, the expandable member thereby preventing the cardioplegic solution from entering the brachiocephalic and carotid arteries.

29. The cannula of claim 26, wherein the angled bend is an approximately 90°

bend relative to the elongated cannula body.

30. The cannula of claim 26, wherein the angled bend is in the range of 20°

to 150°

relative to the elongated cannula body.

31. The cannula of claim 26, wherein the distal end of the elongated cannula body is tapered to facilitate entry of the cannula into the ascending aorta.

32. The cannula of claim 26, wherein the elongated cannula body is dimensioned for suprasternal insertion and extending to the ascending aorta.

33. The cannula of claim 26, wherein the expandable member is an occlusion balloon dimensioned to occlude the ascending aorta.

34. The cannula of claim 33, wherein is formed from an elastomeric material.

35. The cannula of claim 26, wherein the elongated cannula body includes an inflation lumen for inflating the expandable member.

36. The cannula of claim 26, wherein the flange on the distal end of the outer sheath is formed from open cell plastic foam.

37. The cannula of claim 26, wherein at least a portion of the distal end of the outer sheath includes a plurality of pleats which facilitate bending of the outer sheath as it advances over the angled bend in the elongated cannula body.