Apparatus for treatment of ischemic heart disease by providing transvenous myocardial perfusion

• US 5,824,071 A
• Filed: 02/12/1997
• Issued: 10/20/1998
• Est. Priority Date: 09/16/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Circulation, Inc. (ModivCare, Inc.)
• Inventors: Shmulewitz, Ascher, Nelson, James A.
• Primary Examiner(s): Yu, Mickey
• Assistant Examiner(s): CAMPEN, KELLY SCAGGS
• Application Number:
  US08/798,700
• Time in Patent Office: 615 Days
• Field of Search: 128/898, 604/96, 604/49, 604/7-9, 604/93, 604/916, 606/194, 623/3, 623/1, 623/11, 623/900, 600/16
• US Class Current: 606/194
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• 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 2/94 Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/0075 Valve means

Abstract

Apparatus and methods are provided for use in open surgical and transluminal methods for supplying long-term retrograde perfusion of the myocardium via a conduit disposed between the left ventricle and the coronary sinus. In a first method, an opening is formed between the left ventricle and the coronary sinus, and the coronary ostium is partially occluded using a stent that prevents the pressure in the coronary sinus from exceeding a predetermined value. In an alternative method, a first end of a conduit is inserted transeptally through the right atrium and obliquely into the posterior septal endocardium of the left ventricle via the posterior pyramidal space, while a second end of the conduit is inserted into the coronary sinus via the coronary ostium. A pressure-limiting valve is included in the conduit. In either method, the outlet from the left ventricle to the coronary sinus may include a one-way valve to prevent backflow from the coronary sinus into the left ventricle during cardiac diastole.

Claims

1. Apparatus for use in treating ischemic heart disease by providing long-term retrograde transvenous myocardial perfusion, the apparatus comprising:

a conduit adapted to be disposed between a patient'"'"'s left ventricle and the patient'"'"'s coronary sinus, so that blood flows through the conduit from the left ventricle to the coronary sinus during cardiac systole;

means for partially occluding the patient'"'"'s coronary ostium; and

a valve for limiting a peak pressure attained within the coronary sinus by venting blood from the conduit into the patient'"'"'s right atrium when the pressure attained within the coronary sinus exceeds a predetermined value.

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

a cutting instrument adapted for insertion into the coronary sinus via the coronary ostium, the cutting instrument boring through a wall of the coronary sinus, through the patient'"'"'s epicardium, myocardium and endocardium to create a passageway between the left ventricle and the coronary sinus within which the conduit is implanted.

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

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

4. The apparatus as defined in claim 3 wherein the tubular member further comprises a one-way valve that prevents backflow of blood from the coronary sinus to the left ventricle.

5. The apparatus as defined in claim 1 wherein the valve is disposed within a bore of the means for partially occluding the coronary ostium, the valve opening when the pressure exceeds the predetermined value.

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

a tubular member having a first end, a second end, and a lumen extending therebetween, the tubular member comprising a flexible material, the means for partially occluding comprising the second end of the tubular member;

means for engaging the first end of the tubular member in a passageway extending from the right atrial endocardium and into the left ventricular septal endocardium; and

means for engaging the second end of the device in the coronary ostium.

7. The apparatus as defined in claim 6 wherein the first and second ends of the conduit are adapted for transluminal implantation.

8. The apparatus as defined in claim 6 wherein the means for engaging comprises a plurality of ribs or barbs.

9. The apparatus as defined in claim 6 wherein the conduit further 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 6 wherein the valve is disposed in the conduit.

11. A kit for use in treating ischemic heart disease by providing long-term retrograde transvenous myocardial perfusion, the kit comprising:

means for forming a passageway having first and second ends, the first end in fluid communication with a patient'"'"'s left ventricle, the second end in fluid communication with the patient'"'"'s coronary sinus, the passageway providing a lumen for blood flow from the left ventricle to the coronary sinus and extending from an interior surface of the coronary sinus into the left ventricle, the means for forming configured for percutaneous, transluminal insertion into the coronary sinus;

a plug adapted to be disposed in the patient'"'"'s coronary ostium to partially occlude the coronary ostium.

12. The kit as defined in claim 11 wherein the plug further 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.

13. The kit as defined in claim 11 further comprising:

a delivery system adapted for percutaneous insertion into coronary ostium to deliver the plug.

14. The kit as defined in claim 11 further comprising:

a tubular member having a central bore, an exterior surface, and a plurality of engagement means located on the exterior surface, the tubular member configured for percutaneous, transluminal insertion in the passageway so that the plurality of engagement means engage a tissue surface within the passageway.

15. The kit as defined in claim 14 wherein the plurality of engagement means comprises a plurality of ribs or barbs.

16. The kit as defined in claim 14 wherein the tubular member further comprises a one-way valve that prevents backflow of blood from the coronary sinus to the left ventricle.

17. Apparatus for use in treating ischemic heart disease by providing long-term retrograde transvenous myocardial perfusion, the apparatus comprising:

a conduit having first and second ends and an intermediate portion located between the first and second ends, the first end adapted to be disposed in fluid communication with a patient'"'"'s left ventricle, the second end adapted to be disposed in the coronary ostium in fluid communication with the patient'"'"'s coronary sinus, the conduit providing a lumen for blood flow from the left ventricle to the coronary sinus during cardiac systole, a first region of the conduit near the first end adapted to be disposed in a passageway extending between the right atrial endocardium and the left ventricular septal endocardium, the intermediate portion extending into the right atrium;

a valve disposed in the intermediate portion to limit a peak pressure attained within the coronary sinus, the valve venting blood from the coronary sinus into the right atrium when the pressure attained within the coronary sinus exceeds a predetermined value.

18. The apparatus as defined in claim 17 further comprising:

a cutting instrument adapted for percutaneous insertion into the right atrium to create a passageway extending from the right atrial endocardium and into the left ventricular septal endocardium.

19. The apparatus as defined in claim 17 wherein the conduit further comprises:

a tubular member formed from a flexible material;

means for engaging the first region in the passageway extending between the right atrial endocardium and the left ventricular septal endocardium; and

means for engaging the second end within the coronary sinus through the coronary ostium.

20. The apparatus as defined in claim 19 wherein the means for engaging comprises a plurality of ribs or barbs.

21. The apparatus as defined in claim 17 wherein the conduit further comprises a one-way valve disposed within the lumen between the first end and the intermediate portion, the one-way valve preventing backflow of blood from the coronary sinus to the left ventricle.

22. The apparatus as defined in claim 17 wherein the conduit is adapted for percutaneous implantation.