Methods and apparatus for transmyocardial direct coronary revascularization

• US 7,849,860 B2
• Filed: 01/30/2006
• Issued: 12/14/2010
• Est. Priority Date: 10/11/1996
• Status: Expired due to Fees

• Current Assignee: Gowan Company, LLC
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Tumas, Margaret W., Whitt, Jason Brian, Machold, Timothy R., Flaherty, J. Christopher, Makower, Joshua, Lamson, Theodore C., Jensen, Marc
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): SCHILLINGER, ANN M
• Application Number:
  US11/343,936
• Publication Number:
  US 20060184089A1
• Time in Patent Office: 1,779 Days
• Field of Search: 623 11- 242
• 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 delivering blood from a chamber of the heart to a coronary blood vessel, said method comprising the steps of:

a) advancing, into the coronary blood vessel, a catheter having side port and a tissue penetrator that is advancable out of the side port;

b) positioning the catheter such that the side port is directed toward the left ventricle;

c) advancing a tissue penetrator out of the side port, through myocardium located between the coronary blood vessel and the chamber of the heart, and into the chamber of the heart, thereby creating a passageway that extends from the coronary blood vessel to the left ventricle;

d) advancing a guidewire through the passageway;

e) advancing a passageway-modifying apparatus over the guidewire; and

f) using the passageway-modifying apparatus to modify the passageway in a manner that facilitates bloodflow from the chamber of the heart, through the passageway and into the coronary blood vessel;

wherein i) the tissue penetrator has a lumen and, in step d, the guidewire is advanced through the tissue penetrator lumen, ii) after the guidewire has been advanced through the tissue penetrator lumen, the tissue penetrator is withdrawn into the catheter and iii) after the tissue penetrator has been withdrawn into the catheter and prior to performance of step e, the catheter is removed leaving the guidewire within the passageway.

2. The method of claim 1 wherein said coronary blood vessel is selected from the group consisting of:

i) an endogenous coronary artery;

ii) an endogenous coronary vein;

iii) a man-made passageway which has been formed in the heart and which connects to an endogenous coronary vein;

iv) a man-made passageway which has been formed in the heart and which connects to an endogenous coronary artery; and

v) a man-made passageway which extends between an endogenous coronary artery and an endogenous coronary vein.

3. The method of claim 1 wherein said coronary blood vessel is an endogenous coronary vein which is situated next to a coronary artery, and wherein said method further comprises the step of forming a second bloodflow passageway between said coronary vein and the adjacent coronary artery, at a location which is downstream of said transmyocardial bloodflow passageway.

4. The method of claim 3 wherein said second bloodflow passageway is a fistulous tract which extends between said coronary vein and said coronary artery.

5. The method of claim 1 wherein it is intended for blood to flow in a first flow direction through said coronary blood vessel and wherein said method further comprises the step of blocking the lumen of the coronary blood vessel at a location which deters blood from flowing through said coronary blood vessel in a direction other than said first direction.

6. The method of claim 5 wherein said coronary blood vessel is a coronary vein and wherein the lumen of the coronary vein is blocked at a location which prevents blood that enters the coronary vein from the transmyocardial bloodflow passageway from flowing through that coronary vein in the direction of normal venous blood flow, thereby causing said blood to flow through that coronary vein in a direction opposite normal venous bloodflow.

7. The method of claim 1 further comprising the step of placing an intraluminal valving apparatus within the lumen of the coronary blood vessel, 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 from said transmyocardial bloodflow passageway and through the lumen of the coronary vein in a perfusion direction; and

, ii) a closed position whereby blood is prevented from flowing from the coronary vein into said transmyocardial bloodflow passageway, in a backflow direction.

8. The method of claim 7 wherein the intravascular valving apparatus is positioned downstream of the transmyocardial bloodflow passageway, and wherein said method further comprises the step of blocking the lumen of the coronary vein upstream of the transmyocardial bloodflow passageway.

9. The method of claim 1 further comprising the step of 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 vessel, in a first 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 second direction opposite said first direction.

10. The method of claim 9 wherein said tissue valve is formed at the junction of the transmyocardial bloodflow passageway and the coronary blood vessel.

11. The method of claim 10 wherein the tissue valve comprises at least one segment of the coronary blood vessel in combination with at least one underlying segment of myocardial tissue.

12. The method of claim 11 wherein the at least one segment of coronary blood vessel and at least one underlying tapered segment of myocardial tissue which form said valving 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.

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

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

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

ii) a retracted configuration whereby said opening is substantially closed, thereby preventing blood from backflowing from said coronary vein into said transmyocardial bloodflow passageway.

14. The method of claim 13 wherein said elastic closure member is a suture which is formed of elastic material and passed through said myocardial tissue on opposite sides of said transmyocardial bloodflow passageway.

15. The method of claim 1 wherein step f comprises placing a protrusive stent within said transmyocardial passageway, such that said protrusive stent extends into said coronary vessel.

16. The method of claim 15 wherein said protrusive stent is uncovered.

17. The method of claim 15 wherein said protrusive stent is at least partially covered.

18. The method of claim 15 wherein said protrusive stent incorporates at least one valve to intermittently block blood flow, in at least one direction, through said transmyocardial passageway.

19. The method of claim 15 wherein said valve is operative to permit blood to flow from said chamber of the heart through said transmyocardial passageway, and into said coronary vessel, but will prevent blood from backflowing from said coronary vein into said transmyocardial passageway.

20. The method of claim 1 wherein step f comprises enlarging the penetration tract.

21. The method of claim 1 wherein the tract-modifying device comprises a tract-enlarging device and wherein said tract-enlarging device is used in step f to enlarge the penetration tract.

22. The method of claim 1 wherein the tract-modifying device is used to implant an apparatus within the passageway.

23. The method of claim 22 wherein the tract-modifying device is used to implant within the passageway an apparatus selected from the group consisting of:

sleeves, stents and valves.