Methods and apparatus for transmyocardial direct coronary revascularization

• US 20020062146A1
• Filed: 11/26/2001
• Published: 05/23/2002
• Est. Priority Date: 10/11/1996
• Status: Abandoned Application

• 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
• Application Number:
  US09/994,222
• Publication Number:
  US 20020062146A1
• Time in Patent Office: Days
• US Class Current: 623/1.13
• 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

16-1. 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 transmyocardial bloodflow passageway into said coronary vein; and

ii) 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.

17-2. 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.

18-3. 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.

29. A method for transmyocardial direct coronary revascularization, said method comprising the steps of:

a) forming a transmyocardial bloodflow passageway from a chamber of the heart to a coronary blood vessel;

b) permitting blood to flow from the chamber of the heart, through said transmyocardial bloodflow passageway; and

c) into the coronary blood vessel, while said transmyocardial bloodflow passageway remains devoid of any stent positioned therewithin.

48. An intraluminal valving apparatus which is operative to prevent blood from a backflowing from a coronary blood vessel into a transmyocardial bloodflow passageway which extends from a chamber of the heart to said coronary blood vessel, said apparatus comprising:

a generally cylindrical body having an axial bore which extends longitudinally therethrough; and

,

at least one occluder member positioned within said axial bore, said at least one occluder member being alternately moveable between;

i) an open position whereby systolic blood is permitted to pass from said transmyocardial bloodflow passageway, through the lumen of the coronary blood vessel; and

,

ii) a closed position whereby blood is prevented from backflowing from the lumen of the coronary blood vessel into the transmyocardial bloodflow passageway.

59. An intracardiac valving apparatus which is operative to control bloodflow through a transmyocardial bloodflow passageway extending from a chamber of the heart to a coronary blood vessel, said intracardiac valving apparatus comprising:

a valve body having an opening formed therethrough, said valve body being positionable in contact with the wall of the heart such that the opening of said valve body is in alignment with said transmyocardial bloodflow passageway;

at least on occluder member positioned within the opening of said valve body, said occluder member being alternately moveable between;

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

,

ii) a closed position whereby blood is prevented from flowing through said transmyocardial passageway in at least a second direction opposite said first direction.

66. A protrusive stent apparatus for stenting a transmyocardial passageway which extends from a chamber of the heart to a coronary blood vessel, said apparatus comprising:

a tubular body which is alternately configureable in;

i) a radially collapsed configuration of a first diameter;

ii) a radially expanded configuration of a second diameter, said second diameter being at least as large as the diameter of the transmyocardial passageway;

said protrusive stenting apparatus having a length which is longer than the length of the transmyocardial passageway, such that said apparatus may be positioned within said transmyocardial passageway from said cardiac chamber to said coronary blood vessel, with a portion of said apparatus protruding into said coronary blood vessel.

67. The protrusive stent apparatus of claim 66 wherein the tubular body of said stent apparatus is self-expanding.

68. The protrusive stent apparatus of claim 66 wherein the tubular body of said stent apparatus is pressure expandable.

69. The protrusive stent apparatus of claim 66 wherein the tubular body of said stent apparatus is formed of material selected from the group of materials consisting of:

metal;

polymeric material.

70. The apparatus of claim 66 wherein said apparatus further comprises:

a tubular covering formed on said stent.

71. The apparatus of claim 70 wherein said tubular covering is formed of a material selected from the group of materials consisting of:

polyester;

woven polyester;

polytetrafluroethylene;

expanded polytetraflouroethylene;

polyurethane;

silicone;

polycarbonate;

autologous tissue; and

, xenograft tissue.

72. The apparatus of claim 66 wherein said apparatus further comprises:

at least one valve positioned within said tubular body to control bloodflow therethrough.

73. A method for transmyocardial coronary revascularization of a coronary artery having an occlusion formed therein, said method comprising the steps of:

a) providing a passageway-forming catheter comprising an elongate pliable catheter body having at least one tissue-penetrating element which is passable from the catheter body to form an interstitial passageway through tissue;

b) inserting the passageway-forming catheter into the venous vasculature and advancing the catheter until a distal portion of the catheter is located within a coronary vein adjacent the coronary artery wherein the obstruction is present;

c) orienting the passageway-forming catheter such that the tissue-penetrating element is directed toward the coronary artery at a site downstream of the obstruction;

d) passing the tissue-penetrating element from the passageway-forming catheter, through the wall of the coronary vein wherein the catheter is positioned, through any tissue located between the coronary vein and the coronary artery, through the wall of the coronary artery and into the coronary artery, downstream of the obstruction, thereby forming an arterio-venous passageway between said coronary artery and said coronary vein;

e) advancing the passageway-forming catheter through the arterio-venous passageway and into the coronary artery, downstream of the obstruction;

f) orienting the passageway-forming catheter such that the tissue-penetrating element is directed toward a chamber of the heart;

g) passing the tissue-penetrating element from the passageway-forming catheter, through the wall of the coronary artery, through the myocardium and into a chamber of the heart, thereby forming a transmyocardial passageway through which blood may flow from the chamber of the heart and into the coronary artery, downstream of the obstruction;

h) removing the passageway-forming catheter from the body;

i) closing the arterio-venous passageway which had been formed in step d.

74. The method of claim 73 wherein step i comprises placing an occlusion apparatus within said arterio-venous passageway.

75. The method of claim 73 wherein step i comprises applying energy to the tissue surrounding said arterio-venous passageway to close said arterio-venous passageway.

76. The method of claim 75 wherein the energy utilized to close said arterio-venous passageway is selected from the group of energy types consisting of:

electrocautery, heat, radiofrequency, and light.

77. A method for treating myocardial ischemia, said method comprising the steps of:

a) providing a intravascular valving apparatus, said apparatus comprising a frame which is engageable with a surrounding vascular wall and at least one occluder mounted in said frame, said occluder being alternately moveable between a closed position wherein said occluder will block the flow of blood in an outflow direction through said coronary vein, in an open position wherein said occluder will permit blood to flow in said outflow direction through said coronary vein, said occluder being biased to its closed position but being moveable to its open position when the pressure of blood within the coronary vein exceeds a predetermined maximum pressure;

b) implanting the intervascular valving apparatus at a first location within the coronary venous vasculature such that the occluder member of said valving apparatus will prevent the flow of blood in an outflow direction from at least one coronary vein until such time as the pressure of blood within that coronary vein exceeds said predetermined maximum pressure.

78. The method of claim 77 wherein said method further comprises:

forming a transmyocardial passageway from said coronary vein to a chamber of the heart such that blood may flow from the chamber of the heart, through the transmyocardial passageway, and into the coronary vein.

79. The method of claim 78 wherein said myocardial passageway is formed between the left ventricle of the heart and said coronary vein such that oxygenated blood from the left ventricle will flow through the transmyocardial passageway and into the coronary vein.

80. The method of claim 77 wherein the intravascular valving apparatus is implanted within the coronary sinus.

81. The method of claim 77 wherein the intravascular valving apparatus is implanted within the great cardiac vein.

82. A method for performing an intraluminal medical procedure within the lumen of an obstructed coronary artery, at a site downstream of the obstruction, said method comprising the steps of:

a) providing a passageway-forming catheter comprising an elongate pliable catheter body having at least one tissue-penetrating element which is passable from the catheter body to form an interstitial passageway through tissue;

b) inserting the passageway-forming catheter into the venous vasculature and advancing the catheter until a distal portion of the catheter is located within a coronary vein adjacent the coronary artery wherein the obstruction is present;

c) orienting the passageway-forming catheter such that the tissue-penetrating element is directed toward the coronary artery at a site downstream of the obstruction;

d) passing the tissue-penetrating element from the passageway-forming catheter, through the wall of the coronary vein wherein the catheter is positioned, through any tissue located between the coronary vein and the coronary artery, through the wall of the coronary artery and into the coronary artery, downstream of the obstruction, thereby forming an arterio-venous passageway between said coronary artery and said coronary vein;

e) passing an apparatus through said arterio-venous passageway and into the lumen of the coronary, downstream of the obstruction, and utilizing said apparatus to perform said intraluminal procedure;

f) removing the apparatus from the coronary artery, through said arterio-venous passageway; and

closing the arterio-venous passageway which had been formed in step d.

83. The method of claim 82 wherein said intraluminal procedure is selected from the group of intraluminal procedures consisting of:

an atherectomy procedure wherein a passageway is formed through the occlusion in the coronary;

an ablation procedure wherein the obstruction in the coronary artery is ablated;

a thrombolytic procedure wherein a thrombus within the coronary artery is lysed;

a stenting procedure wherein a stent is placed in the lumen of the coronary artery downstream of the obstruction;

a revascularization procedure wherein a blood flow passageway is formed between said coronary artery at a site downstream of the obstruction to another blood-containing anatomical structure such that blood may flow into said coronary artery at a site downstream of the obstruction; and

,

a target apparatus deployment procedure wherein a target apparatus is positioned within the lumen of the coronary artery downstream of the obstruction so as to facilitate targeting of said coronary artery downstream of the obstruction by another device.