Method and apparatus for the guided bypass of coronary occlusions

• US 6,081,738 A
• Filed: 01/15/1998
• Issued: 06/27/2000
• Est. Priority Date: 01/15/1998
• Status: Expired due to Fees

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: LuMend, Inc. (Cardinal Health, Inc.)
• Inventors: Vetter, James W., Milo, Charles F., Hinohara, Tomoaki, Selmon, Matthew R.
• Primary Examiner(s): Casler, Brian L.
• Application Number:
  US09/007,434
• Time in Patent Office: 894 Days
• Field of Search: 600/427, 600/437, 600/462, 600/463, 600/464, 600/466, 600/467, 600/471, 600/407, 600/473, 600/476, 606/151, 606/152, 606/153, 606/154, 606/155, 606/156, 606/167, 606/185, 128/898, 623/1, 623/2
• US Class Current: 600/407
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• 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 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

Described herein is a catheter method and apparatus for the guided intraluminal bypass of a coronary occlusion. A method is described employing an intraluminally operable catheter shaft including an optionally steerable working element, combined with an extraluminally operable locator including an imaging device, to selectively direct the working element to create a fluid path from the artery proximal to the occlusion into the vein and further from the vein back into the artery distal to the occlusion, to perfuse myocardium distal to the occlusion. Methods are described for creating a fluid path from the artery proximal to the occlusion into an adjacent vein and thereafter either stent grafting the fluid path to the vein, directing arterial blood distally within the vein, or stenting the fluid path and occluding the vein proximal thereto, in either case arterializing the venous system distal to the stent or stent graft. A catheter shaft is described for creating and perfusing the fluid path. Conical, guide wire and tissue-penetrating working elements are described. A scanning acoustic transducer and flexible imaging tube, and suction devices for anchoring are described for the locator. A signal-emitting working element and signal-detecting locator cooperating therewith are described.

Claims

1. A method for bypassing an occlusion in a vascular system, comprising the steps of:

providing a catheter apparatus comprising,

an elongated flexible catheter shaft having a distal end zone and a working element disposed in the distal end, and wherein the catheter shaft is formed with a lumen that includes a tissue-penetrating wire at least partially disposed in the lumen of the catheter shaft; and

a locator comprising an imaging tube and an imaging device operatively disposed therein;

placing the working element in the lumen of the first blood vessel, and activating the locator to observe an image of a first blood vessel, the working element therein and a second blood vessel;

manipulating the working element using a steering member comprising a plurality of steering wires slidably disposed in the catheter shaft and coupled to a retaining ring disposed in the distal end zone, wherein braid-reinforced tubes confine each of the plurality of steering wires; and

advancing the working element to establish a path fluidly connecting the lumen of the first blood vessel to the lumen of the second blood vessel.

2. A method as set forth in claim 1, wherein the first blood vessel is an artery.

3. A method as set forth in claim 2, further comprising the

step of introducing the catheter shaft into the arterial system and operating the steering member to steer the working element.

4. A method as set forth in claim 1, wherein the first blood vessel is a vein.

5. A method as set forth in claim 1, further providing the working element and the catheter shaft as a guide wire.

6. A method as set forth in claim 5, further providing the guide wire with a steering wire to steer the guide wire.

7. A method as set forth in claim 1, wherein a bodily surface is proximate the first and second blood vessels and the method comprises the additional step, after placing the locator extraluminally proximate the first and second blood vessels, of removably stabilizing the locator relative to a bodily surface proximate at least one blood vessel, whereby the locator is substantially immobilized with respect to a blood vessel while so attached.

8. A method as set forth in claim 1, further comprising the additional step, after observing the working element to have established a path fluidly connecting the lumen of the first blood vessel to the lumen of the second blood vessel, of placing the catheter shaft in the path so established by the working element to maintain the path.

9. A method as set forth in claim 8, wherein the catheter shaft includes at least one lumen having a proximal fluid path opening and a distal fluid path opening, and the method comprises the additional step of positioning the proximal end of the lumen in the first blood vessel and the distal end of the lumen in the second blood vessel to allow blood to flow between the first and second vessel.

10. A method as set forth in claim 1, wherein the occlusion is in the lumen of the first blood vessel, the method comprising the additional step, after observing the working element to have established a path fluidly connecting the lumen of the first blood vessel to the lumen of the second blood vessel, of:

advancing and steering the working element until the working element is observed to have extended the path so made to fluidly communicate with the lumen of the first blood vessel, whereby a path is created from the first blood vessel into the second blood vessel and continuing from the second blood vessel back into the first blood vessel, the path having a first end in the lumen of the first blood vessel proximal to the occlusion and a second end in the lumen of the first blood vessel distal to the occlusion.

11. A method as set forth in claim 1, further comprising the step of:

establishing a path with a first end fluidly communicating with the lumen of the first blood vessel which is a vein and a second end fluidly communicating with the lumen of the second blood vessel which is an artery at a place proximal to an occlusion.

12. A method as set forth in claim 1, further providing the catheter shaft with a distal end, and further providing the working element with a nose cone disposed on the distal end of the catheter shaft.

13. A method as set forth in claim 1, further providing a plurality of slots partially circumscribing the distal end zone of the catheter shaft.

14. A method as set forth in claim 1, further providing a plurality of rings disposed in the distal end zone of the catheter shaft for defining paths for the steering wires.

15. A method as set forth in claim 1, further comprising the step of:

establishing a fluid path created between the first and second blood vessels with a length, the catheter shaft includes a lumen having proximal end and a distal end, and the proximal end and distal end are separated by at least approximately the length of the fluid path, whereby the lumen of the catheter shaft provides a blood perfusion path while the catheter shaft is placed in the fluid path.

16. A method as set forth in claim 1, wherein the first blood vessel is an artery and the second blood vessel is a vein proximate the artery, the method further comprising the step, after advancing the working element until the working element is observed to have established a path fluidly connecting the lumen of the first blood vessel to the lumen of the second blood vessel, of placing a stent graft in the fluid path, the stent graft directing arterial blood from the fluid path into the lumen of the vein distal to the fluid path to arterialize the vein distal to the fluid path.

17. A method as set forth in claim 1, wherein the first blood vessel is an artery and the second blood vessel is a vein proximate the artery, the method further comprising the steps, after advancing the working element until the working element is observed to have established a path fluidly connecting the lumen of the first blood vessel to the lumen of the second blood vessel, of:

occluding the vein at a location proximal to the fluid path, the occlusion directing arterial blood from the fluid path into the lumen of the vein distal to the fluid path; and

placing a stent in the fluid path sot that the fluid path is kept open and the vein distal to the fluid path is arterialized.

18. A method as set forth in claim 1, wherein the first blood vessel is a vein and the second blood vessel is an artery proximate the vein, the method further comprising the steps, after advancing the working element until the working element is observed to have established a path fluidly connecting the lumen of the first blood vessel to the lumen of the second blood vessel, of:

placing a stent in the fluid path, and

occluding the vein at a location proximal to the fluid path, the occlusion directing arterial blood from the fluid path into the lumen of the vein distal to the fluid path so that the fluid path is kept open and the vein distal to the fluid path is arterialized.

19. An arterial catheter apparatus comprising:

an elongated flexible catheter shaft having a distal end zone and at least one longitudinal lumen extending along at least a portion of the catheter shaft and the distal end zone;

a working element disposed at the distal end zone of the catheter shaft;

a steering member comprising a plurality of steering wires slidably disposed in the catheter shaft and coupled to a retaining ring disposed in the distal end zone, wherein braid-reinforced tubes confine each of the plurality of steering wires;

a tissue-penetrating wire at least partially disposed in the lumen of the catheter shaft and extendable into the distal end zone; and

a locator with an imaging device to provide guidance for the working element and tissue-penetrating wire during treatment of an occlusion.

20. A catheter apparatus as set forth in claim 19, wherein the working element is formed with a substantially conical configuration.