Method and apparatus for transmyocardial direct coronary revascularization

• US 6,929,009 B2
• Filed: 05/16/2002
• Issued: 08/16/2005
• Est. Priority Date: 08/26/1996
• Status: Expired due to Fees

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Machold, Timothy R., Flaherty, J. Christopher, Makower, Joshua, Lamson, Theodore C., Jensen, Marc, Tumas, Margaret W., Whitt, Jason Brian
• Primary Examiner(s): Isabella, David
• Application Number:
  US10/150,306
• Publication Number:
  US 20020179098A1
• Time in Patent Office: 1,188 Days
• Field of Search: 128/898, 606/1, 606/108, 606/167, 606170-171, 604/7, 604/8
• US Class Current: 128/898
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 2017/00504 Tissue welding
• 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
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/12127 : Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61B 2017/306 : holding by means of suction
• CPC Class Codes: A61B 2017/347 : Locking means, e.g. for locking instrument in cannula
• CPC Class Codes: A61B 2018/00392 : Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 90/40 : Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• CPC Class Codes: A61F 2/07 : Stent-grafts
• CPC Class Codes: A61F 2/2412 : with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 : Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2421 : with non-pivoting rigid closure members
• CPC Class Codes: A61F 2/2475 : Venous valves
• CPC Class Codes: A61F 2/2493 : Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2/90 : characterised by a net-like or mesh-like structure
• 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 2002/30079 : magnetic
• CPC Class Codes: A61F 2210/009 : magnetic
• CPC Class Codes: A61F 2220/0008 : Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61M 2025/0076 : Unidirectional valves
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 39/24 : Check- or non-return valves

Abstract

Methods and apparatus for direct coronary revascularization wherein a transmyocardial passageway is formed between a chamber of the heart and a coronary blood vessel to permit blood to flow therebetween. In some embodiments, the transmyocardial passageway is formed between a chamber of the heart and a coronary vein. The invention includes unstented transmyocardial passageways, as well as transmyocardial passageways wherein protrusive stent devices extend from the transmyocardial passageway into an adjacent coronary vessel or chamber of the heart. The apparatus of the present invention include protrusive stent devices for stenting of transmyocardial passageways, intraluminal valving devices for valving of transmyocardial passageways, intracardiac valving devices for valving of transmyocardial passageways, endogenous tissue valves for valving of transmyocardial passageways, and ancillary apparatus for use in conjunction therewith.

Claims

1. A method for transmyocardial coronary revascularization, said method comprising the step of:

1) creating a transmyocardial bloodflow passageway within the heart, said transmyocardial bloodflow passageway extending through the myocardium between a chamber of the heart and a coronary vein.

2. The method of claim 1 wherein said passageway is formed such that blood will flow from the chamber of the heart, through the transmyocardial bloodflow passageway, and through the lumen of the coronary vein, in a retrograde direction, so as to perfuse said region of the myocardium.

3. The method of claim 1 wherein said coronary vein is situated next to a coronary artery, and wherein said method further comprises the step of:

2) forming a fistulous connection between said coronary vein and said adjacent coronary artery, at a location which is downstream of said transmyocardial bloodflow passageway, through said vein, through said fistulous connection, and into the adjacent coronary artery so as to provide enhanced bloodflow through said coronary artery.

4. The method of claim 3 wherein said fistulous connection is a secondary bloodflow passageway which extends from said coronary vein to said coronary artery.

5. The method of claim 1, further comprising the additional step of:

3) blocking the lumen of the coronary vein at a location which is upstream of said transmyocardial bloodflow passageway.

6. The method of claim 3 wherein said method further comprises the steps of:

blocking the lumen of the coronary vein at a location downstream of said fistulous connection.

7. The method of claim 1 further comprising the step of:

b) placing an intraluminal valving apparatus within the lumen of the coronary vein, said intraluminal valving apparatus comprising at least one occluder member which is alternately deployable in;

i) an open position whereby bloodflow is permitted to pass through the transmyocardial bloodflow passageway in a first direction; and

,

ii) a closed position whereby blood is prevented from backflowing through said transmyocardial bloodflow passageway, in a backflow direction.

8. The method of claim 7 wherein said transmyocardial bloodflow passageway is intended to provide a flow of blood from the chamber of the heart into said coronary vein, and wherein said first direction is the direction extending from said chamber of the heart to said coronary vein, and wherein said second direction is the direction extending from said coronary vein to the chamber of the heart.

9. The method of claim 7 wherein said transmyocardial bloodflow passageway is intended to drain blood from the coronary vein into the chamber of the heart, and wherein said first direction is the direction extending from the coronary vein to the chamber of the heart, and said second direction is the direction extending from the chamber of the heart to the coronary vein.

10. The method of claim 7 wherein the intravascular valving apparatus provided in step B is positioned downstream of the transmyocardial bloodflow passageway, and wherein said method further comprises the step of:

4) blocking the lumen of the coronary vein upstream of the transmyocardial bloodflow passageway.

11. The method of claim 7 wherein the intravascualar valving apparatus provided in step B is portioned downstream of the transmyocardial bloodflow passageway, and wherein said method further comprises the step of:

5) placing a second intravascular valving apparatus within the lumen of the coronary vein, upstream of said transmyocardial bloodflow passageway.

12. The method of claim 1 further comprising the step of:

6) forming an endogenous tissue valve which is alternately moveable between;

1) an open position whereby bloodflow is permitted to pass from said transmyocardial bloodflow passageway and through the lumen of said coronary vein, in a perfusion direction; and

,

2) a closed position whereby said tissue valve will prevent blood from flowing from the coronary vein into said transmyocardial bloodflow passageway, in a backflow direction.

13. The method of claim 12 wherein said tissue valve is formed at the junction of the transmyocardial bloodflow passageway and the coronary vein.

14. The method of claim 13 wherein the tissue valve comprises at least one segment of the coronary vein in combination with at least one underlying segment of myocardial tissue.

15. The method of claim 14 wherein at least one segment of coronary vein and the at least one segment of underlying tapered segment of myocardial tissue which form said tissue valve are sized and configured such that, when systolic blood pressure is created within said transmyocardial bloodflow passageway, said tissue valve will move to its open position, and thereafter when diastolic blood pressure is present in said transmyocardial bloodflow passageway, said tissue valve will move to its closed position.

16. The method of claim 1 further comprising the step of:

connecting an elastic closure member to cardiac tissue on either side of said transmyocardial bloodflow passageway, said elastic closure member being alternately transitionable between;

3) a stretched configuration whereby said transmyocardial bloodflow passageway is opened to permit blood to flow said transmyocardial bloodflow passageway into said coronary vein; and

4) a retracted configuration whereby said transmyocardial bloodflow passageway is substantially blocked so as to prevent blood from backflowing from said coronary vein into said transmyocardial bloodflow passageway.

17. The method of claim 16 wherein said elastic closure member comprises a suture which is formed of elastic material, said suture being threaded through said myocardial tissue on opposite sides of said transmyocardial bloodflow passageway.

18. The method of claim 1 further comprising the step of:

7) placing an intracardiac valving apparatus within the chamber of the heart, adjacent one end of said transmyocardial bloodflow passageway, said intracardiac valving apparatus being alternately deployable in;

1) an open position whereby bloodflow is permitted to pass through the transmyocardial bloodflow passageway in a first direction; and

,

2) a closed position whereby through the transmyocardial bloodflow passageway, in a second direction, said second direction being opposite said first direction.

19. The method of claim 18 wherein said transmyocardial bloodflow passageway is intended to provide a flow of blood from the chamber of the heart to the coronary vein, and wherein said first direction is the direction extending from the chamber of the heart to the coronary vein, and said second direction is the direction extending from the coronary vein to the chamber of the heart.

20. The method of claim 18 wherein said transmyocardial bloodflow passageway is intended to drain blood from the coronary vein into the chamber of the heart, and wherein said first direction is the direction extending from the coronary vein to the chamber of the heart, and said second direction is the direction extending from the chamber of the heart to the coronary vein.

21. The method of claim 18 wherein the intracardiac valving apparatus provided in step b is attached to the wall of the chamber of the heart, and is portioned over the opening formed in the chamber of the heart by said transmyocardial bloodflow passageway.

22. The method of claim 21 wherein said intracardiac valving apparatus is sutured to the wall of the chamber of the heart.

23. The method of claim 21 wherein said intracardiac valving apparatus is adhered to the wall of the chamber of the heart.

24. The method of claim 1 further comprising the step of:

8) placing a protrusive stent within said transmyocardial passageway, such that said protrusive stent extends into said coronary vein.

25. The method of claim 24 wherein said protrusive stent is uncovered.

26. The method of claim 24 wherein said protrusive stent is at least partially covered.

27. The method of claim 24 wherein said protrusive stent incorporates at least one valve to intermittently block blood flow, in at least one direction, through said transmyocardial passageway.

28. The method of claim 27 wherein said valve is operative to permit blood to flow from said chamber of the heart through said transmyocardial passageway, and into said coronary vein, but will prevent blood from backflowing from said coronary vein into said transmyocardial passageway.