Method and apparatus for treating ischemic heart disease by providing transvenous myocardial perfusion

• US 6,447,539 B1
• Filed: 09/15/1997
• Issued: 09/10/2002
• Est. Priority Date: 09/16/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: TransVascular, Inc. (Medtronic Plc)
• Inventors: Burton, John, Shmulewitz, Ascher, Nelson, James A.
• Primary Examiner(s): Millin, Vincent
• Assistant Examiner(s): CAMPEN, KELLY SCAGGS
• Application Number:
  US08/929,076
• Time in Patent Office: 1,821 Days
• Field of Search: 128/898, 604/49, 604/96, 604/7-9, 604/93.01, 604/916, 606/194, 623/3, 623/1.1, 623/1.11, 623/11, 623/900, 600/16
• US Class Current: 623/1.11
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2250/0013 for adjusting fluid pressure

Abstract

Methods and apparatus are provided for use in intraoperative and percutaneous procedures for supplying long-term retrograde perfusion of the myocardium via one or more conduits disposed between the left ventricle and the coronary venous vasculature. The conduits are of a selected size and number, and portions of the venous vasculature or coronary ostium are partially or completely occluded, to maintain a parameter related to the pressure attained in the venous vasculature to a value less than a predetermined value.

Claims

1. Apparatus for use in treating ischemic myocardium of a human or animal patient by providing retrograde transvenous myocardial perfusion, the apparatus comprising a kit including:

a device for forming a passageway, substantially within the patient'"'"'s myocardium between the left ventricle and venous vasculature;

a conduit adapted to be transluminally disposed substantially within the passageway formed between a patient'"'"'s left ventricle and the patient'"'"'s venous vasculature, the conduit having an outlet in the patient'"'"'s venous vasculature, the conduit adapted to channel a volume of blood from the left ventricle to the venous vasculature;

means for achieving a preselected degree of occlusion of the patient'"'"'s venous vasculature proximal of the outlet to direct the volume of blood to the ischemic myocardium; and

,

means for limiting the peak pressure attained in the patient'"'"'s venous vasculature to less than 60 mm Hg.

2. The apparatus as defined in claim 1 further comprising:

a cutting instrument for boring a transmural passageway through the myocardium between the left ventricle and a selected portion of the patient'"'"'s venous vasculature.

3. The apparatus as defined in claim 2 wherein the cutting instrument is adapted for insertion into the coronary sinus via the coronary ostium, the cutting instrument comprising:

a catheter having a distal end, and a lumen that accepts a guidewire; and

a sharpened tubular member disposed on the distal end of the catheter.

4. The apparatus as defined in claim 2 wherein the cutting instrument forms a transmural passageway having a predetermined cross-sectional area.

5. The apparatus as defined in claim 2 wherein the conduit comprises a lumen defined by tissue surrounding the transmural passageway.

6. The apparatus as defined in claim 1 wherein the means for achieving a preselected degree of occlusion also limits a parameter related to the pressure attained in the patient'"'"'s venous vasculature.

7. The apparatus as defined in claim 1 wherein the conduit comprises:

a tubular member having a bore, an exterior surface, and a plurality of engagement means located on the exterior surface.

8. The apparatus as defined in claim 7 wherein the tubular member further comprises means for regulating flow of blood through the tubular member.

9. The apparatus as defined in claim 8 wherein the means for regulating comprises a one-way valve that prevents backflow of blood from the coronary sinus to the left ventricle.

10. The apparatus as defined in claim 8 wherein the means for regulating comprises a constriction in the bore.

11. The apparatus as defined in claim 1 wherein the means for achieving a preselected degree of occlusion comprises a valve that limits a peak pressure attained within the coronary sinus by venting blood from the coronary sinus into the patient'"'"'s right atrium when the pressure attained within the coronary sinus exceeds a predetermined value.

12. The apparatus as defined in claim 1 wherein the means for achieving a preselected degree of occlusion comprises:

a woven mesh having a delivery configuration, wherein the woven mesh is longitudinally stretched to a radially contracted position, and a deployed configuration, wherein the woven mesh is released from longitudinal restraint and radially expands;

a biocompatible coating disposed on the woven mesh; and

means for forming a constriction in a midregion of the woven mesh.

13. The apparatus as defined in claim 1 wherein the means for achieving a preselected degree of occlusion comprises a plug of open-cell foam having high durometer.

14. The apparatus as defined in claim 1 wherein the means for achieving a preselected degree of occlusion comprises:

a deformable tubular member having a delivery diameter for transluminal delivery, and an expanded diameter, wherein the tubular member is deformably expanded by internal application of a radially outwardly directed force; and

a layer of open-cell foam affixed to an exterior surface of the deformable tubular member.

15. A method of providing retrograde transvenous myocardial perfusion to treat ischemic myocardium, the method comprising:

forming a conduit between a patient'"'"'s left ventricle and the patient'"'"'s venous vasculature, the conduit having an outlet in the patient'"'"'s venous vasculature, the conduit channeling blood from the left ventricle to the venous vasculature; and

at least partially occluding the patient'"'"'s venous vasculature proximally of the outlet to direct retrograde blood flow to the ischemic myocardium.

16. The method as defined in claim 15 further comprising regulating a parameter related to the pressure attained in the patient'"'"'s venous vasculature.

17. The method as defined in claim 16 wherein regulating a parameter comprises placing a constriction in the conduit.

18. The method as defined in claim 16 further comprising periodically adjusting the a degree of occlusion of the patient'"'"'s venous vasculature.

19. The method as defined in claim 16 wherein regulating a parameter comprises limiting a peak pressure attained in the patient'"'"'s venous vasculature to a value less than 60 mm Hg.

20. The method as defined in claim 19 wherein limiting a peak pressure comprises venting blood from the coronary sinus into the patient'"'"'s right atrium when the pressure attained within the coronary sinus exceeds 60 mm Hg.

21. The method as defined in claim 15 wherein forming a conduit comprises:

providing a cutting instrument; and

manipulating the cutting instrument to bore a transmural passageway through the myocardium between the left ventricle and a selected portion of the patient'"'"'s venous vasculature.

22. The method as defined in claim 21 wherein manipulating the cutting instrument comprises positioning the cutting instrument at a desired location by inserting the cutting instrument through the coronary ostium and into the coronary sinus.

23. The method as defined in claim 15 wherein forming a conduit forms a transmural passageway having a predetermined cross-sectional area.

24. The method as defined in claim 15 wherein the conduit comprises a flexible member having a first end, a second end, and a lumen extending therebetween, and forming a conduit comprises:

engaging the first end of the flexible member in fluid communication with the left ventricle; and

engaging the second end of the flexible member in the coronary ostium.

25. The method as defined in claim 24 further comprising positioning the conduit within a passageway extending from the right atrial endocardium to the left ventricular septal endocardium.

26. The method as defined in claim 24 wherein engaging the first end of the flexible member in fluid communication with the left ventricle comprises suturing a sewing ring to the epicardium.