Transluminal method for bypassing arterial obstructions

• US 6,655,386 B1
• Filed: 08/16/2000
• Issued: 12/02/2003
• 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: Evard, Philip Christopher, Macaulay, Patrick Edward, Garibotto, John Thomas, Machold, Timothy R., Banks, Thomas, Redmond, Russell J., Flaherty, J. Christopher, Makower, Joshua, Vidal, Claude A., Whitt, Jason Brian
• Primary Examiner(s): Isabella, David J.
• Application Number:
  US09/639,963
• Time in Patent Office: 1,203 Days
• Field of Search: 128/898, 604/101, 604/7, 604/89, 604/104, 604/96, 604/53, 604/49, 606/191, 606/192, 606/193, 606/194, 600/16
• US Class Current: 128/898
• 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 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/12136 Balloons
• 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 2017/00331 : with preformed bends
• CPC Class Codes: A61B 2017/00504 : Tissue welding
• CPC Class Codes: A61B 2017/00637 : for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00668 : the implement being a tack or a staple
• CPC Class Codes: A61B 2017/0641 : having at least three legs as part of one single body
• 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 2017/12127 : 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 2017/22095 : accessing a blood vessel true lumen from the sub-intimal space
• 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 2018/00404 : Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00869 : Phase
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/1475 : Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2090/378 : using ultrasound
• CPC Class Codes: A61B 2090/3925 : ultrasonic
• CPC Class Codes: A61B 2090/3929 : Active markers
• 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 2025/0076 : Unidirectional valves
• 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

Abstract

Methods, devices, and systems for a) revascularization and/or b) performing other medical procedures at vascular or non-vascular intracorporeal locations within a mammalian body. The methods generally comprise the formation of at least one extravascular passageway from a blood vessel to a vascular or non-vascular target location. In the revascularization methods the extravascular passageway is utilized for blood flow. In the medical procedure methods the extravascular passageway is utilized as a conduit for accessing or performing procedures at the vascular or non-vascular target location. Also disclosed are catheter devices and systems which are useable to form the extravascular passageways of the invention, as well as apparatus for modifying, maintaining and/or closing such extravascular passageways.

Claims

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

a) forming an extravascular passageway between a first location on a blood vessel and a second location on a blood vessel, such that blood having a PO₂, of at least 50 will flow through said extravascular passageway;

wherein Step a is carried out by;

i) providing a passageway-forming catheter device comprising an elongate flexible catheter body having a tissue-penetrating element passable therefrom so as to penetrate through the wall of a blood vessel in which said catheter body is inserted;

ii) inserting said catheter body into the vasculature and positioning said catheter body such that the tissue-penetrating element is located adjacent the location at which said extravascular passageway is to be formed;

iii) passing said tissue-penetrating element from said catheter body so as to form said extravascular passageway.

2. The method of claim 1 wherein said first location and said second location are on at least one blood vessel of the heart.

3. The method of claim 1 wherein said first location and said second location are on the same blood vessel.

4. The method of claim 1 wherein said first location and said second location are on different blood vessels.

5. The method of claim 4 wherein said blood vessels are a artery and a vein.

6. The method of claim 4 wherein said blood vessels are a vein and a vein.

7. The method of claim 4 wherein said blood vessels are an artery and an artery.

8. The method of claim 4 wherein a plurality of said extravascular passageways are formed between said blood vessels.

9. The method of claim 1 wherein said extravascular passageway is formed for the purpose of bypassing an obstructed, injured or diseased segment of a blood vessel.

10. The method of claim 1 wherein said first location is on an artery and said second location is on a vein, such that blood will flow from said artery, through said extravascular passageway, and into said vein.

11. The method of claim 10 wherein blood which has entered the vein through said extravascular passageway is subsequently caused to flow through said vein so as to retroperfuse tissue through the venous vasculature.

12. The method of claim 11 wherein blood is caused to flow through the vein so as to retroperfuse tissue through venous vasculature by:

b) blocking said vein at a location to cause blood which flows into said vein through said extravascular passageway to subsequently flow through said vein in a direction which will cause said retroperfusion of tissue through the venous vasculature.

13. The method of claim 1 wherein the extravascular passageway formed in step a is a primary extravascular passageway formed between a first blood vessel and a second blood vessel such that blood having a pO₂ of at least 50 will flow from the first blood vessel, through said extravascular passageway, and into the second blood vessel.

14. The method of claim 13 wherein said method further comprises the step of:

b) forming at least one secondary extravascular passageway between said second blood vessel and another blood vessel of the heart such that blood which has entered the second blood vessel through the first extravascular passageway will subsequently flow into another blood vessel through said secondary extravascular passageway.

15. The method of claim 14 wherein said blood is caused to flow into the other blood vessel through the secondary extravascular passageway by:

c) blocking the second blood vessel at a location to cause said blood to flow from said second blood vessel through said second extravascular passageway and back into said other blood vessel.

16. The method of claim 1 wherein at least one of said first and second locations are on a blood vessel which is part of a system of blood vessels wherein an obstructed, injured or diseased segment of a blood vessel is present.

17. The method of claim 1 wherein step further comprises:

providing an orientation means for locating said first and second locations and for orienting the catheter device such that the tissue-penetrating element of the catheter will pass from said first location to said second location, thereby forming said extravascular passageway between said first location on a blood vessel and said second location on a blood vessel.

18. The method of claim 1 wherein the tissue penetrating element of the device provided in step i further incorporates a lumen through which a guide wire may be passed upon creation of said extravascular passageway by said tissue-penetrating element, and wherein said method further comprises the step of:

passing a guide wire through said lumen and allowing said guide wire to remain extended through said extravascular passageway following extraction and removal of said catheter, to thereby provide for subsequent advancement of one or more other apparatus through said passageway, over said guide wire.

19. A method for revascularization, said method comprising the step of:

a) forming an extravascular passageway between a first location on an artery and a second location on a vein, such that blood having a pO₂, of at least 50 will flow through said extravascular passageway and into the vein; and

,

b) blocking the vein at a location to cause blood which flows into the vein through the extravascular passageway to subsequently flow through the vein in a direction which will cause retroperfusion of tissue through the venous vasculature.

20. The method of claim 19 wherein at least one of said first location and said second location are on a blood vessel of the heart.

21. The method of claim 19 wherein a plurality of said extravascular passageways are formed between said blood vessels.

22. The method of claim 19 wherein said extravascular passageway is formed for the purpose of bypassing an obstructed, injured or diseased segment of a blood vessel.

23. The method of claim 19 wherein said method further comprises the step of:

c) forming at least one secondary extravascular passageway between the vein into which the blood flows through the extravascular passageway and at least one other blood vessel such that blood which has entered the vein through the first extravascular passageway will subsequently flow into at least one other blood vessel through at least one secondary extravascular passageway.

24. The method of claim 23 wherein said blood is caused to flow into the other blood vessel through the secondary extravascular passageway by:

d) blocking the vein at a location to cause said blood to flow from the vein through at least one secondary extravascular passageway and into at least one other blood vessel.

25. The method of claim 19 wherein step a of said method is carried out by:

i) providing a passageway-forming catheter device comprising an elongate flexible catheter body having a tissue-penetrating element passable therefrom so as to penetrate through the wall of a blood vessel in which said catheter body is inserted;

ii) inserting said catheter body into the vasculature and positioning said catheter body such that the tissue-penetrating element is located adjacent the location at which said extravascular passageway is to be formed;

iii) passing the tissue-penetrating element from said catheter body so as to form the extravascular passageway in Step a.

26. The method of claim 25 wherein step i further comprises:

providing an orientation element for locating the first and second locations and for orienting the catheter device such that the tissue-penetrating element of the catheter will pass from said first location to said second location, thereby forming the extravascular passageway.

27. The method of claim 25 wherein the tissue penetrating element of the device provided in step i further incorporates a lumen through which a guide wire may be passed upon creation of said extravascular passageway by said tissue-penetrating element, and wherein said method further comprises the step of:

passing a guide wire through said lumen and allowing said guide wire to remain extended through said extravascular passageway following extraction and removal of said catheter, to thereby provide for subsequent advancement of one or more other apparatus through the passageway, over the guide wire.