Methods and apparatus for transmyocardial direct coronary revascularization

• US 7,159,592 B1
• Filed: 11/09/2000
• Issued: 01/09/2007
• Est. Priority Date: 10/13/1995
• 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 J.
• Application Number:
  US09/710,332
• Time in Patent Office: 2,252 Days
• Field of Search: 128/898, 604/49, 604/96, 604/7, 604/8, 604/9, 606/194, 606/1, 606/108, 606/167, 606/170, 606/171, 623/1.1, 623/1.11
• 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 Y-shaped blood vessel prostheses A61F2002/065
• 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 steps of:

a) creating a bloodflow passageway that extends through myocardial tissue between a chamber of the heart and a coronary vein such that blood will flow from the chamber of the heart, through the bloodflow passageway and into the coronary vein; and

b) causing the blood that flows from the chamber of the heart, through the bloodflow passageway and into the coronary vein to flow through the coronary vein in a direction opposite normal venous blood flow; and

c) placing an intraluminal valving apparatus within the lumen of the coronary vein, said intraluminal valving apparatus having an opening through which blood emanating from the bloodflow passageway may flow and at least one occluder member that is alternately moveable between i) an open position whereby systolic blood is permitted to pass from the bloodflow passageway into the lumen of the coronary vein, and ii) a closed position whereby blood is prevented from backflowing from the lumen of the coronary vein into the bloodflow passageway.

2. 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:

b) forming a fistulous connection between said coronary vein and said adjacent coronary artery, at a location which is downstream of said transmyocardial bloodflow passageway, such that blood may flow from the chamber of the heart, through 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.

3. The method of claim 2 wherein said fistulous connection is a secondary bloodflow passageway which extends from said coronary vein to said coronary artery.

4. The method of claim 1 wherein Step b comprises blocking the lumen of the coronary vein at a location proximal to the location at which the bloodflow passageway enters the coronary vein, thereby causing the blood that enters the coronary vein from the blood flow passageway to flow through the coronary vein in a direction that is opposite normal venous blood flow.

5. The method of claim 4 wherein the lumen of the coronary vein is blocked by placing an embolic member within the lumen of the coronary vein.

6. The method of claim 4 wherein the lumen of the coronary vein is blocked by placing an intraluminal valving apparatus within the lumen of the coronary vein said intraluminal valving apparatus being alternately disposed in i) an open configuration which allows blood to flow through the lumen of the coronary vein in the direction of normal venous blood flow and ii) a closed configuration which prevents blood from flowing through the lumen of the coronary vein in the direction of normal venous bloodflow, said intraluminal valving apparatus being constructed to remain in its closed configuration until the pressure of blood within the lumen of the coronary vein distal to the intraluminal valving apparatus exceeds a predetermined maximum pressure, at which time the intraluminal valving apparatus will transition to its open configuration.

7. 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;

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

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

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

b) 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;

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 the transmyocardial bloodflow passageway, in a second direction, said second direction being opposite said-first direction.

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

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

i) 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

,

ii) 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.

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

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

i) 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

,

ii) 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.

11. The method of claim 10 wherein said tissue valve is formed at the junction of the transmyocardial bloodflow passageway and the coronary vein.

12. The method of claim 11 wherein the tissue valve comprises at least one segment of the coronary vein in combination with at least one underlying segment of myocardial tissue.

13. The method of claim 12 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 diasfcolic blood pressure is present in said transmyocardial bloodflow passageway, said tissue valve will move to its closed position.

14. 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;

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

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

15. The method of claim 12 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 fransmyocardial bloodflow passageway.

16. The method of claim 12 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 fransmyocardial bloodflow passageway.

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

b) 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;

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 the transmyocardial bloodflow passageway, in a second direction, said second direction being opposite said-first direction.

18. The method of claim 17 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.

19. The method in claim 17 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.

20. The method of claim 17 wherein the intracardiac valving apparatus provided in step b is attached to the wall of the chamber of the heart, and is positioned over the opening formed in the chamber of the heart by said fransmyocardial bloodflow passageway.

21. The method of claim 20 wherein said intracardiac valving apparatus is sutured to the wall of the chamber of the heart.

22. The method of claim 20 wherein said intracardiac valving apparatus is adhered to the wall of the chamber of the heart.

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

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

24. The method of claim 23 wherein said protrusive stent is uncovered.

25. The method of claim 23 wherein said protrusive stent is at least partially covered.

26. The method of claim 23 wherein said protrusive stent incorporates at least one valve to intermittently block blood flow, in at least one direction, through said transmyocardial passageway.

27. The method of claim 1 wherein the intraluminal valving apparatus has a generally cylindrical body and an axial bore which extends longitudinally therethrough and wherein said at least one occluder member is positioned within said axial bore.

28. The method of claim 27 wherein the opening through which blood emanating from the bloodflow passageway may flow comprises a side aperture formed in the generally cylindrical body of said intraluminal valving apparatus, and wherein said side aperture is alienable with the bloodflow passageway such that blood from the bloodflow passageway may flow through said side aperture and into the axial bore of the intraluminal valving apparatus.

29. The method of claim 28 wherein said at least one occluder member is configured to close off said side aperture when in its closed position, such that a subsequent increase in blood pressure within the bloodflow passageway will move said occluder member to said open position, thereby reopening said side aperture.

30. The method of claim 29 wherein said at least one occluder member is positioned within the axial bore of the intraluminal valving apparatus such that during systole, bloodflow which passes from the bloodflow passageway into the axial bore of the intraluminal valving apparatus will force the occluder member to its open position thereby allowing bloodflow from the bloodflow passageway into the lumen of the coronary vein and, thereafter, during diastole, the occluder member will move to its closed position, thereby preventing blood from backflowing from the lumen of the coronary vein into the bloodflow passageway.

31. The method of claim 28 wherein the intraluminal valving apparatus further comprises a blocking member which closes off the axial bore of the intraluminal valving apparatus proximal to said side aperture.

32. The method claim 28 wherein the intraluminal valving apparatus further comprises a secondary occluder member that closes off the axial bore of the intraluminal valving apparatus proximal to the side aperture.

33. The method of claim 1 wherein the intraluminal valving apparatus is positioned within the coronary vein at a location distal to the location at which the bloodflow passageway enters the coronary vein, and wherein said at least one occluder member permits blood to flow through the lumen of the coronary vein in a direction opposite normal venous flow when said at least one occluder member is in its open position, and to prevent blood from backflowing through the coronary vein in the direction of normal venous flow when said at least one occluder member is in its closed position.

34. The method of claim 1 wherein two of said intraluminal valving apparatus are positioned in the lumen of the coronary vein, one of said valving apparatus being located proximal to the location at which the bloodflow passageway enters the coronary vein and the other of said valving apparatus being positioned distal to the location at which the bloodflow passageway enters the coronary vein.