WO2006046244A2

WO2006046244A2 - Method and apparatus for diverting a guidewire through a bifurcated passageway

Info

Publication number: WO2006046244A2
Application number: PCT/IL2005/001120
Authority: WO
Inventors: Yoav Turgeman; Ascher Shmulewitz; Eran Hirszowicz
Original assignee: Yoav Turgeman; Ascher Shmulewitz; Eran Hirszowicz
Priority date: 2004-10-26
Filing date: 2005-10-26
Publication date: 2006-05-04
Also published as: WO2006046244A3

Abstract

A method and apparatus for diverting a guidewire and/or catheter through a bifurcated passageway (e.g., blood vessel). The apparatus comprises an elongated tube (17) having an inner lumen (2) being accessible via a proximal end opening (6), a distal end opening (1), and a first and second side openings (3a, 3b) provided on a distal section of said elongated tube, wherein the lumen comprises a partitioning element (5) located in the distal section such that it partitions the lumen into a first and second separate lumens such that the first lumen is accessible via said first side opening and via said proximal end opening and the second lumen is accessible via the second side opening and via the distal end opening. A method for diverting a guidewire and/or catheter along a desired pathway through a bifurcated passageway by using this apparatus is also described.

Description

METHOD AND APPARATUS FOR DIVERTING A GUIDEWIRE THROUSH A

BIFURCATED PASSAGEWAY

Field of the Invention

The present invention relates to a method and apparatus for diverting a guidewire through a bifurcated passageway . More particularly, the invention relates to a method and apparatus for maneuvering a guidewire or catheter towards a destined treatment site through a bifurcated body vessel or cavity such as blood vessels, respiratory airways, etc.

Background of the Invention

Passing guidewires through a bifurcated body passageway (e.g., blood vessel) is an initial mandatory step in many percutaneous therapeutic intervention. For example, in the coronary tree, multiple anatomical and post surgical variations create a tremendous challenge for the physician to direct and propagate wires into angulations of the vascular bifurcations of about 90°. Such bifurcations include T-type bifurcations and multiple tortuosities, including retxograde navigation into a native vessel through a bypass graft.

Directing guidewires and/or catheters through such branching passageways lead to prolonged procedure times, ^"thereby exposing the patient to different maneuvers, m/ultiple guidewires and balloons, etc., and leading to increased risk for procedure-related complications.

For example, when a treatment site is to be accessed via a bifurcated blood vessel a guidewire having a J-shaped tip is typically used. The J-shaped guidewire is inserted into a blood vessel through an incision and its location in the blood vessel is visualized using X-ray for instance. The physician maneuvers the J-shaped guidewire through turns and bifurcated vessels by rotating the guidewire about it axis.

US 6,231,563 (to Geoffrey H. White et al) describe an intraluminal catheter for directing a guidewire and/or catheter in a desired direction within a bodily vessel or cavity. This intraluminal catheter comprises a main elongate tube adapted to slide over a main guidewizte positioned in the vessel, and a second elongated tube having an end portion that is deflectable relative to the locus of the main tube to direct a supplementary guidewire passing tlirough an additional elongated tube into the bodily vessel in a direction transverse to the locus of the main guidewire.

US 2002/055732 (to W. Stan Wilson) describe a catheter assembly for advancing a pair of guidewires to a bifurcated vessel. This catheter assembly comprises two guidewire lumens which are substantially parallel to each other throughout their lengths, and it allows for the delivery of two wires to a bifurcation for carrying out an interventional procedure, such as implantation of a bifurcated stent .

US 2003/028233 (to Gil M. Vardi et al) describe a method for positioning a stent at a vessel bifurcation. A side opening is provided in the main stent that is positioned at the ostium of a branch vessel. A stent delivery system comprising a catheter with a flexible side sheath is advanced over a main guidewire passing in the main vessel such that its distal end extends past the bifurcation. The main stent is positioned over the catheter with the flexible side sheath positioned to pass throiαgh the interior of the main stent and out of the side opening in the main stent. A branch guidewire is advanced through the flexible side sheath attached to the catheter and into the branch vessel.

The methods described above have not yet provided satisfactory solutions for directing a guidewire and/or catheter through substantially narrow bifurcated passageways. Therefore there is a need for a method and apparatus for directing a guidewire and/or a catheter through a bifurcated body vessel or cavity.

It is therefore an object of the present invention to provide a method and apparatus for advancing a guidewire and/or catheter through relatively narrow bifurcated body vessel or cavity, such as in the coronary tree.

It is another object of the present invention to provide a relatively slender navigation catheter suitable for advancing a guidewire and/or catheter through relatively narrow bifurcated body vessel or cavity by using a single guidewire.

It is a further object of the present invention to provide a method for directing a guidewire and/or catheter through a relatively narrow and complicated, bifurcated passageway by using a single guidewire.

It is yet another object of the present invention to provide a catheter suitable for advancing a guidewire and/or catheter through a bifurcated passageway where the angle between the passageway and it branching passageway is greater than or equal to 90°.

Other objects and advantages of the invention will become apparent as the description proceeds. Summary of the Invention

The present invention provides a method and. apparatus for diverting a guidewire and/or catheter through a bifurcated passageway such as blood vessels, respiratorry airways, and body cav±ties.

The present invention is primarily directed to an apparatus for diverting a guidewire and/or catheter through a bifurcated passageway (e.g., blood vessels) . The apparatus preferably comprise an elongated tube having an inner lumen being accessible via a proximal end opening, a dist al end opening, and a first and second side openings provided on a distal section of the elongated tube, wherein the lαmen comprises a partitioning element located in said distal section such that it partitions the lumen into a first and second separate lumens such that the first lumen is accessible via the first side opening and via the proximal end opening and the second opening is accessible via the second side opening and via the distal end opening.

The partitioning element is preferably adapted to force a guidewire advanced along the first lumen to exit the first lumen in a predetermined exit angle relative to the axis of the elongated tube.

Conveniently, the first and second side openi-ngs are located on opposing vertical sides of the elongated tube.

The elongated tube may further comprise a score between its proximal end opening and a point between tlie proximal end opening and its proximal side opening from which a guidewire may be removed from, or introduced into, the paroximal lumen. According to another preferred embodiment of the invention the apparatus for diverting a guidewire and/ox catheter through a bifurcated passageway is comprised of a main elongated tube having an inner lumen being accessible via a proximal end opening and a distal exit opening thereof and a supplementary tube having an inner lumen being accessible via a proximal entrance opening and a distal end opening thereof, wherein a distal end section of the main elongated tube is attached to the supplementary tube along a corresponding proximal end section thereof.

Preferably, the distal exit opening of the main elongated tube is designed to provide a desired exit angle of a guidewire passing therethrough relative to the main elongated tube.

The present invention is also directed to a method for diverting a guidewire and/or catheter along a desired pathway through, a bifurcated passageway, comprising:

- providing a navigation catheter having separated proximal and distal lumens, wherein the proximal lumen is accessible from its distal side via a first s ide opening of the navigation catheter, and from its pxoximal side via a proximal end opening of the navigation catheter, and wherein the distal lumen is accessible from its proximal side via a second side opening of the navigation catheter, and from its distal side via a distal end opening of the navigation catheter;

- inserting a guidewire capable of being advanced through the first and second lumens into a bifurcated passageway until a distal tip thereof passes a bifurcation to be passed along the desired pathway;

- advancing the navigation catheter over the guidewire by threading its distal lumen thereon and placing the navigation catheter therein such that its first side opening is positioned in the vicinity of the bifurcation;

- retracting the guidewire proximally; and

- advancing the guidewire and/or a catheter device through the prroximal lumen and adjusting the orientation of the navigation catheter such that the first opening faces the bifurcation and a distal portion of the advanced guidewire and/or catheter device exits the proximal lumen through the first side opening into a branching passageway at the bifurcation.

The method may further comprise retracting the navigation catheter proximally over the guidewire and/or catheter device.

Brief Description of the Drawings

The present invention is illustrated by way of example in the accompanying drawings, in which similar- references consistently indicate similar elements and in which:

Fig. IA shows a longitudinal-section side view of a navigation catheter constructed from a single tube according to a preferred embodiment of the invention;

Fig . IB shows a longitudinal-section top view of a the navigation catheter of the invention;

Fig . 2 schematically illustrates advancing "the navigation catheter of the invention over a guidewire towards a bifurcation;

Fig . 3 schematically illustrates advancing the guidewire into a bifurcated passage; and

Fig . 4 is a longitudinal-section of a navigation catheter constructed from a main longitudinal tube attached at its distal end to a supplementary tube according to another preferred embodiment of the invention. DetaJLled Description of Preferred Embodiments

The present invention is directed to a navigation catheter, and to a procedure used therewith, for directing and navigating guidewires through branching body passageways. The present invention also aims to substantially simplify and shorten the intervention time required in such procedures.

The navigation catheter 10 of the present invention, as shown in F-Lg. IA, may be constructed from an elongated flexible tube 17 comprising a single lumen 2. Navigation catheter 10 compxrise two end openings, a distal end opening 1 and a proxi_mal end opening 6, and two side openings, proximal side open±ng 3b and distal side opening 3a_r located on a distal portion of elongated tube 17.

Navigation catheter 10 further comprises a partition 5, disposed in a distal portion of the lumen of elongated tube 17 between proximal side opening 3b and distal side opening 3a. Partition 5 preferably has either straight, diagonal, or curved inner walls, 5a and 5b. Distal irxner wall 5a is located proximally adjacent to distal side opening 3a, such that distal lumen portion 2a may be accessed via distal side opening 3a and/or via distal end opening 1. Similarly, proximal inner wall 5b is located distally adjacent to proximal side opening 3b, such that distal lumen portion 2b may be accessed via proximal side opening 3b and/or via proximal end opening 6.

As will be explained herein below with, reference to Figs. 2 and 3, partition 5 is utilized for diverting the path of a guidewire 15 introduced via proximal end opening 6 or via distal end opening 1, from a straight (longitudinal) path into an angled path. Navigation catheter 10 is preferably designed to enable guidewire 15 inserted via one of its end openings (1 and/or 6) to exit lumen 2 via a corresponding side opening (3a and/or 3b) at a desired angle θ, relative to the longitudinal axis of elongated tube 17. A desired exit angle θ of guidewire 15 can be obtained by properly positioning partition 5 between the side openings and by a suitable design of its inner walls, 5a and 5b.

Navigation catheter 10 of the invention is preferably longitudinally scored along its outer surface, as shown in Fig. IB. Longitudinal score 8 is preferably introduced along the wall of elongated tube 17 between proximal end opening 6 and to a point between proximal end opening 6 and proximal side opening 3b, thereby allowing "peel-away" technique to be used during the procedure. Longitudinal score 8 allows the removal of guidewire 15 from the side of catheter 10 via longitudinal score 8, or alternatively, allows introducing guidewire 15 into proximal lumen 2b via longitudinal score 8, thus allowing the use of a relatively short guidewire in the procedures performed therewith.

The catheter insertion procedure of the invention is preferably performed under X-ray visioning (Image Guided Surgery) , and is initiated by inserting the guidewire 15 into body passageway 11 (e.g., blood vessel) until its distal tip passes bifurcation 12 into which it shouild be inserted. The navigation catheter is then threaded over guidewire 15 via its distal lumen 2a, such that it is guided over its distal end opening 1 and its distal side opening 3a, until its distal end portion reaches bifurcation 12, as shown in Fig. 2.

Guidewire 15 is then retracted outwardly via side opening 3a and xemoved outside passageway 11. Thereafter, guidewire 15 is inserted, into proximal lumen 2b through proximal end opening 6 (or via longitudinal score 8) of the navigation catheter 10. Guidewirre 15 is then advanced through proximal lumen 2b and the navigation catheter 10 is manipulated simultaneously such that its proximal side opening 3b is pnroperly positioned alongside (facing) the entrance to passageway 11a branching at bifurcation 12. Guidewire 15 is then advanced in proximal lumen 2t> until it exits elongated tube 17 via proximal side opening 3b and enters the branching passageway 11a, as shown in Fig. 3. If the destined treatment si_te is located in branching passageway 11a, Navigation catheter 10 is then removed and the treatment catheter is inserted therein over the guidewire 15.

Obviously, the above procedure can be repeated multiple times using the same guidewire and navigation catheter, for arrival at treatment locations that require passing more than one bifurcation.

Elongated tube 17 can be made of biocompatible polymers such as polyurethane, nylon, Teflon and metal that are routinely used in catheter production. Partition 5 can be made of biocompatible materials such as stainless steel or hard polymers and it may be integrated into elongated tube 17 during its manufacture, or adhered or welded in lumen 2. The length of partition 5 is generally in the range of 3 mm to 10 mm, preferably about 4 mm. The length of distal lumen 2a is generaLly in the range of 10 to 100 mm, preferably about 20 mm, and the length of proximal lumen 2b i_s generally in the range of 500 to 1500 mm, preferably about 750 mm. Guidewire 15 may be any suitable guidewire as commonly ixsed in percutaneous therapeutic intervention, such as manufactured by Guidant, Cordis etc. Fig. 4 shows a longitudinal-section view of a navigation catheter 40 according to another preferred embodiment of the invention. Navigation catheter 40 is constructed from a main longitudinal tube 45 which distal end portion is attached to a proximal end portion of a supplementary tube 47. Main longitudinal tube 45 comprise a proximal end opening 46 and an exit opening 44, and supplementary tube 47 comprise a distal end opening 41 and a proximal entrance opening 43.

Navigation catheter 40 may be used in a similar fashion, as was described hereinabove with reference to Figs. 1A-1B, 2 and 3. Similarly, desired exit angle of guidewire introduced via proximal end opening 46 and advanced through proximal lumen 48 of main longitudinal tube 45, can be obtained by a corresponding design of the location of exit opening 44. Distal lumen 42 of supplementary tube 47 and its proximal opening 43 are preferably aligned to allow straight passage of guidewire through lumen 42 thereof.

Main longitudinal tube 45 and supplementary tube 47 can be made of biocompatible polymers such as polyurethane, nylon, Teflon and metal that are routinely used in catheter production. Said tubes can be attached by adhering (e.g., ther-mobounding, ultrasonic UV) or welding a distal end portion in the range of 5 mm to 50 mm of main longitudinal tube 45 to a proximal end portion of a corresponding length of supplementary tube 47. The length of main longitudinal tube 45 is generally in the range of 500 mm to 1500 mm, preferably abomt 750 mm, and the length of supplementary tube 47 is generally in the range of 20 mm to 120 mm, preferably about 40 mm. The navigation catheter may be manufactured in any size suitable for its intended use. As a general guide, the navigation catheter will have a length of 100 to 200 cm and an external diameter in between 0.5 to 1.5 mm. The navigation catheter of the present invention can be manufactured by means of any of the standard techniques which are routinely used in the manufacture of catheters. For example: Extrusion, molding, tipping, hole punching, etc.

As was described and exemplified herein above the navigation catheter of the invention can be effectively used for advancing a guidewire and/or catheter through relativel y narrow bifurcated body vessel or cavity, such as blood vessel s (e.g., the coronary tree) . It should be appreciated that the navigation catheter of the invention may be efficiently used for passing a guidewire, catheter, or other suitable accessories through bifurcated passageways where the angle between the passageway and the branching passageway is greater than or equal to 90°.

All of the abovementioned parameters are given by way of example only, and may be changed in accordance with thie differing requirements of the various embodiments of th\e present invention. Thus, the abovementioned parameters shou]_d not be construed as limiting the scope of the present invention in any way. In addition, it is to be appreciated that the different tubes, openings, and other members, described hereinabove may be constructed in different shapes (e.g. having oval, square etc. form in plan view) and sizes from those exemplified in "the preceding description.

The above examples and description have of course been provided only for the purpose of illustration, and are not intended to limit the invention in any way. As will be appreciated by the skilled person, the invention can be carried out in a. great variety of ways, employing more than one technique from those described above, all without exceeding the scope of the invention.

Claims

1. An apparatus for diverting a guidewire and/or catheter through a bifurcated passageway, comprising an elongated tube having an inner lumen being accessible via a proximal end opening, a distal end opening, and a first and second side openings provided on a distal. section of said elongated tube, wherein said lumen comprises a partitioning element located in said distal section such that it partitions said lumen into a first and second separate lumens such that said first lumen is accessible via said first side opening and via said proximal end opening and said second lumen is accessible via said second side opening and via said distal end opening.

2. The apparatus of claim 1, wherein the partitioning element is adapted to force a guidewire advanced along the first lumen to exit said first lumen in a predetermined angle relative to axis of the elongated tube.

3. The apparatus of claim 1, wherein the first and second side openings are located on opposing verrtical sides of the elongated tube.

4. The apparatus of claim 1, wherein the elongated tube further comprises a score between its proximal end opening and a point between said proximal end opening and its prox±mal side opening from which a guidewire may be removed from_Λ or introduced into, the proximal lumen.

5. The apparatus of claim 1, wherein the bifurcated passageway is a blood vessel.

6. An apparatus for diverting a guidewire and/or catheteur through a bifurcated passageway, comprising a main elongated tube having an inner lumen being accessible via a proximal end opening and a distal exit opening thereof and a supplementary tube having an inner lumen being accessible via a proximal entrance opening and a distal end opening thereof, wherein a distal end section of said main elongated tube is attached to said supplementary tube along a corresponding proximal end section thereof.

7. The apparatus of claim 6, wherein the distal exit opening of the main elongated tube is designed to provide a desired exit angle of a guidewire passing therethrough relative to said main elongated tube.

8. A method for diverting a guiLdewire and/or catheter along a desired pathway through a bifurcated passageway_^ comprising: a) providing a navigation catheter having separated proximal and distal lumens, wherrein said proximal lumen is accessible from its distal side via a first side opening of said navigation catheter, and from its proximal side via a proximal end opening of said navigation catheter_^ and wherein said distal lumen is accessible from its proximal side via a second side opening of said navigation catheter, and from its distal side via a distal end opening of said navigation catheter; b) inserting a guidewire capable of being advanced through said first and second lumens into a bifurcated passageway until a distal tip thereof passes a bifurcation to be passed along said desired pathway; c) advancing said navigation catheter over said guidewire by^ threading its distal lumen thereon and placing said navigation catheter therein such that its first side opening is positioned in the vicinity of said bifurcation; d) retracting said gmidewire proximally; and e) advancing said guidewire and/or a catheter device through said proximal lumen and adjusting the orientation of said navigation catheter such that said first opening faces said bifurcation and a distal portion of the advanced guidewire and/or catheter device exits said proximal lumen through said first opening into a brranching passageway at said bifurcation.

9. The method of claim 8, further comprising retracting said navigation catheter proximally over said guidewire and/or a catheter device.

10. The method of claim 8, wherein the bifurcated passageway is a blood vessel.