Methods for bypassing or near-total obstructions in arteries or other anatomical conduits

• US 20030236542A1
• Filed: 02/19/2003
• Published: 12/25/2003
• Est. Priority Date: 10/13/1995
• Status: Active Grant

• Current Assignee: TransVascular, Inc. (Medtronic Plc)
• Original Assignee: TransVascular, Inc. (Medtronic Plc)
• Inventors: Makower, Joshua
• Granted Patent: US 7,179,270 B2
• Time in Patent Office: Days
• US Class Current: 606/167
• 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 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• 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 2017/00641 : for closing fistulae, e.g. anorectal fistulae
• 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 2017/306 : 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 2090/3925 : 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 2025/018 : 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 for bypassing total or near-total obstructions in arteries or other anatomical conduits. A guidewire is advanced through the lumen of the artery or anatomical conduit upstream of the obstruction and past the obstruction. In navigating past the obstruction, this guidewire may advance through tissue that is located within the wall of the artery or anatomical conduit and/or through tissue that is located outside of the wall of the artery or anatomical conduit. After this guidewire has been advanced past the obstruction, a penetrating catheter that is equipped with an orientation element is advanced over that guidewire. The orientation element is then used to aim a penetrator back into the lumen of the obstructed artery or conduit, downstream of the obstruction. The penetrator is then advanced into the lumen of the obstructed artery or conduit, downstream of the obstruction, and a final guidewire is advanced through the penetrator and into the lumen of the artery or conduit downstream of the obstruction. The catheter (and the guidewire that was initially used to pass the obstruction) may then be removed, leaving the final guidewire in place. A balloon or other tract enlarging device may be used to dilate or otherwise enlarge the bypass tract through which the final guidewire extends. Also, a covered or uncovered stent may be placed within the tract to facilitate flow from the lumen of the artery or anatomical conduit upstream of the obstruction, through the newly created bypass tract and back into the lumen of the artery or anatomical conduit downstream of the obstruction.

Claims

1. A method for bypassing an obstruction in a luminal anatomical conduit that has a wall, said method comprising the steps of:

A. providing a first elongate member having a distal end;

B. advancing the first elongate member to a position where its distal end is within the lumen of the anatomical conduit, proximal to the obstruction;

C. causing the distal end of the first elongate member to penetrate into or through the wall of the anatomical conduit;

D. further advancing the first elongate member through or outside of the wall of the anatomical conduit to a position where the distal end of the first elongate member is distal to the obstruction and outside of the lumen of the anatomical conduit;

E. providing a catheter device that comprises i) an elongate, flexible catheter body having a distal end, ii) a lumen extending longitudinally through at least a distal portion of the catheter body to permit the catheter device to be advanced over an elongate member, iii) a penetration member having a distal end, said penetration member being advanceable on an advancement trajectory from the catheter body while the catheter body is positioned within an anatomical conduit said penetrator being penetrable into or through the wall of the anatomical conduit in which the catheter body is positioned, said penetration member having a lumen that extends longitudinally therethrough such that a second elongate member may be advanced through the penetration member and out of its distal end and iv) an orientation element useable to enable the operator to determine the rotational orientation of the catheter body relative to the advancement trajectory of the penetrator to enable the operator to adjust the rotational orientation of the catheter body prior to advancement of the penetrator from the catheter body so that subsequent advancement of the penetrator on the advancement trajectory will cause the penetrator to advance to a target location;

F. advancing the catheter device over the first elongate member to a position where the distal end of the catheter body is positioned outside of the lumen of the anatomical conduit, distal to the obstruction;

G. rotationally orientating the catheter body with the aid of the orientation element such that, when the penetration member is subsequently advanced from the catheter body, the penetration member will enter the lumen of the anatomical conduit distal to the obstruction;

H. advancing the penetration member from the catheter body and into the lumen of the anatomical conduit distal to the obstruction;

I. providing a second elongate member having a distal end; and

,

J. advancing the second elongate member through the lumen of the penetration member to a position where the distal end of the second elongate member is within the lumen of the anatomical conduit distal to the obstruction.

2. A method according to claim 1 further comprising the step of:

K. removing the catheter device, leaving the second elongate member in place.

3. A method according to claim 2 further comprising the steps of:

L. advancing a stent delivery catheter with a stent over the third elongate member;

M. deploying and radially expanding the stent; and

,

N. removing the stent delivery catheter, leaving the stent in place, such that fluid may flow from the lumen of the anatomical conduit proximal to the obstruction, through the lumen of the stent and back into the lumen of the anatomical conduit distal to the obstruction.

4. A method according to claim 1 wherein the anatomical conduit is a blood vessel.

5. A method according to claim 4 wherein the blood vessel is an artery.

6. A method according to claim 5 wherein Step C comprises advancing the distal end of the first elongate member through the intima of the artery.

7. A method according to claim 6 wherein Step D comprises further advancing the first elongate member within the artery wall, to the position where the distal end of the first elongate member is distal to the obstruction and within the wall of the artery outside of the artery'"'"'s lumen.

8. A method according to claim 6 wherein Step D comprises further advancing the first elongate member outside of the artery wall, to the position where the distal end of the first elongate member is distal to the obstruction and outside of the artery wall.

9. A method according to claim 8 wherein the artery is a coronary artery and the first elongate member is advanced in Step D through the myocardium.

10. A method according to claim 8 wherein the wall of the artery is substantially surrounded by a membrane and wherein the first elongate member is advanced in Step D through tissue that is within the membrane but outside of the artery wall.

11. A method according to claim 1 wherein the first elongate member is a guidewire.

12. A method according to claim 1 wherein the second elongate member is a guidewire.

13. A method according to claim 1 wherein the orientation element of the catheter device comprises at least one radiographically visible marker that indicates the rotational orientation of the catheter on a radiographic image and enables the operator to rotationally orient the catheter body such that when the penetration member is subsequently advanced from the catheter body, the penetration member will enter the lumen of the anatomical conduit distal to the obstruction.

14. A method according to claim 1 wherein the orientation element of the catheter device comprises at least one imaging apparatus that provides an indication of the rotational orientation of the catheter body relative to the lumen of the anatomical conduit thereby enabling the operator to rotationally orient the catheter body such that when the penetration member is subsequently advanced from the catheter body, the penetration member will enter the lumen of the anatomical conduit distal to the obstruction

15. A method according to claim 1 wherein the orientation element of the catheter device comprises at least one sensor that is useable in conjunction with other apparatus that create(s) a sensing field to indicate the rotational orientation of the catheter body relative to the lumen of the anatomical conduit thereby enabling the operator to rotationally orient the catheter body such that when the penetration member is subsequently advanced from the catheter body, the penetration member will enter the lumen of the anatomical conduit distal to the obstruction

16. A method according to claim 1 further comprising the steps of:

advancing a tract enlarging device over the first elongate member, and,

using the tract enlarging device to enlarge the tract created by the advancement of the first elongate member in Step D.

17. A method according to claim 16 wherein the steps of advancing and using the tract enlarging device are carried out after performance of Step D but before performance of Step F.

18. A method according to claim 2 further comprising the steps of:

L. advancing a tract enlarging device over the second elongate member, and,

M. using the tract enlarging device to enlarge the tract through which the second elongate member extends.

39. A method according to claim 1 wherein another elongate tissue-tract forming apparatus other than the first elongate member is initially used in Steps C and D and wherein the method further comprises exchanging the elongate tissue-tract forming apparatus for the first elongate member after performance of Step D but before performance of Step E.

19. A method for bypassing an obstruction in a luminal anatomical conduit that has a wall, said method comprising the steps of:

A. providing a first elongate member having a distal end;

B. advancing the first elongate member to a position where its distal end is within the lumen of the anatomical conduit, proximal to the obstruction;

C. providing a catheter device that comprises i) an elongate, flexible catheter body having a distal end, ii) a lumen extending longitudinally through at least a distal portion of the catheter body to permit the catheter device to be advanced over an elongate member, iii) a penetration member having a distal end, said penetration member being advanceable from the catheter body while the catheter body is positioned within an anatomical conduit such that the penetration member penetrates into or through the wall of the anatomical conduit in which the catheter body is positioned, said penetration member having a lumen that extends longitudinally therethrough such that a second elongate member may be advanced through the penetration member and out of its distal end and iv) an orientation element useable to enable the operator to determine the rotational orientation of the catheter body relative to the advancement trajectory of the penetrator to enable the operator to adjust the rotational orientation of the catheter body prior to advancement of the penetrator from the catheter body so that subsequent advancement of the penetrator on the advancement trajectory will cause the penetrator to advance to a target location;

D. advancing the catheter device over the first elongate member to a position where the distal end of the catheter body is positioned within the lumen of the anatomical conduit, proximal to the obstruction;

E. advancing the penetration member from the catheter body and into or through the wall of the anatomical conduit;

F. providing a second elongate member having a distal end;

G. advancing the second elongate member through the penetrator, out of the distal end of the penetrator and through tissue located within or outside of the wall of the anatomical conduit, to a position where the distal end of the second elongate member is distal to the obstruction and outside of the lumen of the anatomical conduit;

H. withdrawing and removing the catheter device leaving the second elongate member in place;

I. advancing the catheter device over the second elongate member to a position where the distal end of the catheter device is distal to the obstruction and outside of the lumen of the anatomical conduit;

J. rotationally orientating the catheter body with the aid of the orientation element such that, when the penetration member is subsequently advanced from the catheter body, the penetration member will enter the lumen of the anatomical conduit distal to the obstruction;

K. advancing the penetration member from the catheter body and into the lumen of the anatomical conduit distal to the obstruction;

L. providing a third elongate member having a distal end; and

,

M. advancing the third elongate member through the lumen of the penetration member to a position where the distal end of the third elongate member is within the lumen of the anatomical conduit distal to the obstruction.

20. A method according to claim 19 further comprising the step of:

N. removing the catheter device, leaving the third elongate member in place.

21. A method according to claim 20 further comprising the steps of:

O. advancing a stent delivery catheter with a stent over the third elongate member;

P. deploying and radially expanding the stent; and

,

Q. removing the stent delivery catheter, leaving the stent in place, such that fluid may flow from the lumen of the anatomical conduit proximal to the obstruction, through the lumen of the stent and back into the lumen of the anatomical conduit distal to the obstruction.

22. A method according to claim 19 wherein the anatomical conduit is a blood vessel.

23. A method according to claim 22 wherein the blood vessel is an artery.

24. A method according to claim 23 wherein Step E comprises advancing the distal end of the penetration member through the intima of the artery.

25. A method according to claim 24 wherein Step E comprises advancing the penetration member to a sub-intimal location within the artery wall and wherein Step F comprises advancing the second elongate member through tissue substantially within the artery wall, to the position where the distal end of the second elongate member is distal to the obstruction within the wall of the artery and outside of the artery'"'"'s lumen.

26. A method according to claim 24 wherein Step E comprises advancing the penetration member through the wall of the artery and wherein Step F comprises advancing the second elongate member through tissue at least some of which is outside of the artery wall, to a position where the distal end of the second elongate member is distal to the obstruction and outside of the artery wall.

27. A method according to claim 26 wherein the artery is a coronary artery and the second elongate member is advanced in Step F through the myocardium.

28. A method according to claim 26 wherein the wall of the artery is substantially surrounded by a membrane and wherein the second elongate member is advanced in Step F through tissue that is within the membrane but outside of the artery wall.

29. A method according to claim 19 wherein the first elongate member is a guidewire.

30. A method according to claim 19 wherein the second elongate member is a guidewire.

32. A method according to claim 19 wherein the third elongate member is a guidewire.

33. A method according to claim 19 wherein the orientation element of the catheter device comprises at least one radiographically visible marker that indicates the rotational orientation of the catheter on a radiographic image and enables the operator to rotationally orient the catheter body such that when the penetration member is subsequently advanced from the catheter body, the penetration member will enter the lumen of the anatomical conduit distal to the obstruction.

34. A method according to claim 19 wherein the orientation element of the catheter device comprises at least one imaging apparatus that provides an indication of the rotational orientation of the catheter body relative to the lumen of the anatomical conduit thereby enabling the operator to rotationally orient the catheter body such that when the penetration member is subsequently advanced from the catheter body, the penetration member will enter the lumen of the anatomical conduit distal to the obstruction

35. A method according to claim 19 wherein the orientation element of the catheter device comprises at least one sensor that is useable in conjunction with other apparatus that create(s) a sensing field to indicate the rotational orientation of the catheter body relative to the lumen of the anatomical conduit thereby enabling the operator to rotationally orient the catheter body such that when the penetration member is subsequently advanced from the catheter body, the penetration member will enter the lumen of the anatomical conduit distal to the obstruction

36. A method according to claim 20 further comprising the steps of:

advancing a tract enlarging device over the second elongate member, and,

using the tract enlarging device to enlarge the tract created by the advancement of the second elongate member in Step G.

37. A method according to claim 36 wherein the steps of advancing and using the tract enlarging device are carried out after performance of Step H but before performance of Step I.

38. A method according to claim 20 further comprising the steps of:

L. advancing a tract enlarging device over the third elongate member, and,

M. using the tract enlarging device to enlarge the tract through which the third elongate member extends.

40. A method according to claim 19 wherein another elongate tissue-tract forming apparatus other than the second elongate member is initially used in Step G and wherein the method further comprises exchanging the elongate tissue-tract forming apparatus for the second elongate member after performance of Step G but before performance of Step H.