Percutaneous in-situ coronary bypass method and apparatus

• US 6,283,983 B1
• Filed: 08/10/1998
• Issued: 09/04/2001
• Est. Priority Date: 10/13/1995
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: TransVascular, Inc. (Medtronic Plc)
• Inventors: Makower, Joshua, Schwartz, Robert S., Van Tassel, Robert A., Holmes, David R.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US09/192,554
• Time in Patent Office: 1,121 Days
• Field of Search: 606/1, 606/108, 606/192, 606/194, 606/195, 606/198, 606/200, 623/1, 623/12, 623/1.11, 623/1.13, 623/1.14, 604/96
• US Class Current: 606/198
• CPC Class Codes: A61B 1/3137 for examination of the interior of blood vessels
• 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 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• 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 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• 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 18/1445 at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
• 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 18/24 with a catheter A61B18/26, A61B18/28 take 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 2017/003 : Steerable
• CPC Class Codes: A61B 2017/00504 : Tissue welding
• CPC Class Codes: A61B 2017/1107 : for blood vessels
• CPC Class Codes: A61B 2017/1139 : Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/1205 : Introduction devices
• CPC Class Codes: A61B 2017/12127 : Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61B 2017/22038 : with a guide wire
• CPC Class Codes: A61B 2017/22077 : with a part piercing the tissue A61B2017/22044 takes precedence
• 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 2017/3488 : Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00392 : Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00869 : Phase
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2090/378 : using ultrasound
• CPC Class Codes: A61B 2090/3958 : emitting a signal
• CPC Class Codes: A61B 90/361 : Image-producing devices, e.g. surgical cameras
• 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 2/2493 : Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2/90 : characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 : Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/30079 : magnetic
• CPC Class Codes: A61F 2002/8486 : provided on at least one of the ends
• CPC Class Codes: A61F 2210/009 : magnetic
• CPC Class Codes: A61M 2025/0004 : having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0076 : Unidirectional valves
• CPC Class Codes: A61M 2025/009 : the needle having a bent tip, i.e. the needle distal tip is angled in relation to the longitudinal axis of the catheter
• CPC Class Codes: A61M 2025/0096 : being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/018 : Catheters having a lateral opening for guiding elongated means lateral to the catheter
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2210/125 : Heart

Abstract

Methods and devices for percutaneous, in situ coronary bypass wherein a tissue puncturing catheter is used to form blood flow paths between an artery and an adjacent vein such that arterial blood will flow through a segment of the adjacent vein, thereby bypassing a lesion in the artery. The tissue puncturing catheter comprises a flexible catheter having a tissue puncturing apparatus such as a sharp tipped member, an electro-surgical apparatus or a laser beam passable therefrom to create the desired blood flow paths between the artery and vein. Stents are provided for facilitating blood flow through the blood flow paths and the segment of the vein used as the bypass conduit. One such stent is specially constructed to carry arterial blood in one direction through the vein segment while allowing venous blood to continue to flow in the opposite direction through that venous segment.

Claims

1. A method for percutaneous, in-situ coronary bypass in a a lesion located in a coronary artery of a mammalian patient, said method comprising the steps of:

(A) providing a flexible catheter which has a tissue piercing instrument passable therefrom;

(B) inserting said catheter into the vasculature and positioning at a first location within a coronary blood vessel;

(C) passing the tissue piercing instrument from the catheter to form a blood flow path between the coronary artery proximal to the lesion and a coronary vein;

(D) repositioning the catheter at a second location within a coronary blood vessel; and

,

(E) passing the tissue piercing instrument from the catheter a second time to form a second blood flow path between the coronary artery distal to the lesion and said coronary vein.

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

(F) placing a blocking stent in said coronary vein proximal to the proximal blood flow path formed in Step C.

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

(F) placing an elongated stent such that it extends through the blood flow paths created in Steps C and E and through the segment of said vein between said blood flow paths.

4. The method of claim 3 wherein the stent placed in step F comprises:

a braided tubular core covered by a fluid impervious layer.

5. The method of claim 4 wherein the fluid impervious layer of the stent is treated to encourage endothelial cell growth.

6. The method of claim 3 wherein the stent placed in Step F is configured to carry arterial blood in one direction through said segment of said coronary vein while allowing venous blood to naturally flow in the other direction through said segment of said coronary vein.

7. A stent for use in an in-situ arterial bypass, the bypass extending from the lumen of an artery, through a first opening in an artery wall, through the lumen of an adjacent vein and into the lumen of an artery through a second opening in an artery wall, the stent comprising:

an elongate, flexible tubular member having an interior surface, an exterior surface, a first end, a second end, and a hollow interior passage extending therethrough from the first end to the second end, the first and second ends being sized to engage the first and second artery wall openings and prevent longitudinal movement of the stent following implantation and the portion of the stent that extends between its first and second ends being sized relative to the diameter of the vein lumen such that arterial blood will be channeled through the stent in a direction opposite normal venous flow and venous blood will be permitted to flow through the vein lumen, past the stent, in the direction of normal venous flow.

8. The stent of claim 7, wherein cuffs are provided on the first and second ends of the tubular member.

9. The stent of claim 7, wherein disks are provided on the first and second ends of the tubular member.

10. The stent of claim 7, wherein laps are provided on the first and second ends of the tubular member.

11. The stent of claim 7, wherein flanges are provided on the first and second ends of the tubular member.

12. The stent of claim 7, wherein the tubular member comprises a braided tubular core covered by a fluid impervious layer.

13. The stent of claim 12, wherein the fluid impervious layer is treated so as to encourage endothelial cell growth thereon.

14. The stent of claim 12, wherein the first and second ends of the tubular member are selected from the group of structures consisting of:

a disk structure;

a cuff structure;

a lap structure; and

a flange structure.

15. The stent of claim 7, wherein the tubular member has a diameter that is smaller than the diameter of the lumen of the vein such that venous blood is permitted to flow through the vein when the stent is in the bypass position.

16. The stent of claim 15, wherein the first and second ends of the tubular member are selected from the group of structures consisting of:

a disk structure;

a cuff structure;

a lap structure; and

a flange structure.