WO2012168936A1

WO2012168936A1 - Devices and methods for bypassing occlusions in vessels

Info

Publication number: WO2012168936A1
Application number: PCT/IL2012/000222
Authority: WO
Inventors: Ronen SHOUSHAN; Yehuda G. Wolf
Original assignee: Safeback Re-Entry Medical Ltd
Priority date: 2011-06-09
Filing date: 2012-06-07
Publication date: 2012-12-13

Abstract

ABSTRACT A device for bypassing an occlusion in a vessel is provided. The device includes an elongated device body having a central channel which configured for accommodating a guidewire. The distal portion of the device is configured for forcing apart tissue layers of a wall of the vessel to thereby angle a portion of an inner layer into a lumen of the vessel and pulling the angled inner tissue layer against a distal end of the elongated device body thereby enabling a guide-wire advanced through the central channel and out of the distal end to puncture through the inner tissue layer and into the lumen of the vessel downstream of the occlusion.

Description

DEVICES AND METHODS FOR BYPASSING OCCLUSIONS IN VESSELS

FIELD OF THE INVENTION

The present invention generally pertains to a device and method for by crossing occlusions in vessels of a patient with a guide-wire facilitated in a catheter and more specifically for treating chronic total (arterial) occlusion (CTO).

Furthermore, the present invention generally relates to devices and methods for bypassing occlusions in biological vessels of a patient. Specifically, the present invention relates to a catheter-like device which can be used to angle an inner tissue layer of a vessel wall with respect to a distal end of the device thereby enabling a guidewire delivered through the distal end to puncture through the inner tissue layer and into the vessel lumen.

BACKGROUND OF THE INVENTION

The present invention relates to devices and methods for treating occlusions such as chronic total occlusions (CTOs) in blood vessels such as arteries.

A Chronic total occlusion (CTO) is characterized by heavy plaque burden within the artery, resulting in complete (or nearly complete) occlusion of the vessel. CTOs are the most common reason for failure of endovascular intervention and referral to open surgery. A prerequisite to endovascular treatment of these lesions is the crossing of the occlusions with a guide wire on which therapeutic interventions such as balloon dilation, stent placement and other interventions can be performed. In order to achieve this crossing consistently, reliably and safely, new devices and instrumentation are needed.

The most common cause of arterial occlusive disease is atherosclerosis. Atherosclerosis is a chronic, progressive disease of the arteries in which "plaques" made up of cholesterol deposits, calcium, and abnormal cells develop on the inner lining of the arteries.

Chronic total occlusions exist in both coronary and peripheral arteries, but have been histologically characterized mostly in the coronary arteries. It has been shown that their composition is irregular and changes over time. Specifically, the plaque is not homogenous and contains regions of different composition and structure with multiple neovascular channels.

Outside the lesion and within the outer layer of the arterial wall (the adventitia), the subintimal plane is a consistent potential space of loosely adherent layers. In an effort to avoid the complications associated with open surgical operations, wire-based devices for endovascuiar treatment of CTO have been introduced. Traditionally, it has been accepted that staying within the lumen and the plaque, rather than outside it, is preferred, so that when the guide wire exits the occlusion, it is within the arterial lumen beyond it. However, traversing the plaque, which may be hard and calcified, is often difficult even with the use special high- end guide wires with very stiff tips. To increase the success rate, several devices have been or are being developed. These include among others the Frontrunner (Cordis, J&J), which is based on blunt microdissection, the Crosser (Flowcardia, Sunnyvale, CA), in which high- frequency vibration is used to facilitate guide wire navigation, the Safe- cross (Intraluminal Therapeutics, Carlsbad, CA), which uses radiofrequency ablation, the Excimer laser catheter (Spectranetics, Colorado Springs CO), CTOS oscillating guide wire (Re Vascular therapeutics Sunnyvale CA), CiTop guide wire (Ovalum Medical Vision, Rehovot Israel) with steerable J- tip guide wire control, and the Niobe system for manipulating mstrumentation within magnetic fields. In addition, pharmaco-therapy with local injection of collagenase (Bradley Strauss, Toronto) is being investigated.

Subintimal angioplasty

An important endovascuiar technique used to treat total occlusions is subintimal angioplasty, where a dissection plane is intentionally developed beside the occlusion in the subintimal plane (outside the natural arterial lumen and outside the atherosclerotic plaque, outside the intima and inside the adventitia). This plane is entered from the lumen distal to the occlusion and the device (wire or catheter) within it is advanced to beyond the occlusion. At this point and preferably not too far away from the termination of the occlusion, the lumen has to be reentered.

The appeal of the subintimal route is that it is always available, irrespective of the structure and composition of the atherosclerotic plaque. It may be difficult to enter this plane with a guide wire, however, because it requires puncturing the intima at some point distal to the occlusion to reach this plane from the arterial lumen. Once inside this plane with a guide wire, the wire can usually be advanced with a relatively low resistance. The most difficult and least controlled step in this procedure is the reentry. This last step is occasionally difficult and if the guide wire does not re-enter the true lumen close to the occlusion the entire endovascuiar procedure may have to be abandoned. Once the guide wire has entered the lumen beyond the occlusion, the intervention proceeds as usual with balloon dilation and stent application, as required. Three devices which have been designed to control the re-entry site are on the market. Two devices are similar and use a curved hollow needle, which is driven off center (sideways), to perforate the intima and enter the lumen from the sub ntimal plane at the desired location. Through this needle, a guide wire is advanced to the distal lumen, and from this point on the procedure can proceed as usual.

One device is the Outback reentry catheter by Cordis J&J and the other is the Pioneer catheter by Medtronic. Both catheters have a large profile which is a disadvantage, especially for use in smaller arteries. Both catheters require precise rotational orientation, so that the needle is driven into the true lumen and not outside the adventitia and the artery. The outback relies on fluoroscopy and a radio-opaque rotation marker, the Pioneer incorporates an IVUS (intravascular ultrasound) catheter for orientation. A third device is a reentry balloon catheter where a flat low profile balloon helps orient the wire towards the lumen (Bridgepoint medical, Minneapolis, Minnesota)

Crossing of a CTO in practice

While techniques of crossing the occlusion through the plaque (i.e. intra-luminal) and subrntimal angioplasty are presented above as two essentially different procedures, they are in essence quite similar. In fact, it is occasionally difficult to judge along which plane the guide wire has actually crossed the total occlusion, whether within the plaque or in the subintimal plane.

The interior of the occluding plaque is mhomogeneous in terms of composition and structure and even within the subintimal plane there may be varying resistance to guide wire advancement as well. Therefore a means to enhance passage of a guide wire to the desired site of reentry, may be helpful.

Thus, a device and method especially adapted to bypass occlusions remains a long-felt but as yet unmet need.

SUMMARY OF THE INVENTION

It is one object of the present invention to provide a catheter for bypassing an occlusion in a vessel of a patient, comprising:

a. at least one open-bore type lumen in fluid contact with a source of suction, said lumen characterized by a distal end and a proximal end interconnected by a main longitudinal axis substantially parallel to the main longitudinal axis of said catheter, said proximal end located outside the body of said patient during the course of said treatment;

b. at least one guide wire, accommodated within said lumen, reciprocally maneuverable along and around said main longitudinal axis of said lumen; said guide- wire is adapted to penetrate the intima at said occlusion's proximal end and to puncture the intima at at said occlusion's distal end so as to perform reentry to said lumen and to by-pass/cross said occlusion and,

c. at least one effecter having a distal end and a proximal end; characterized by at least one inactive configuration and at least one active configuration, said active configuration characterized by at least a portion of the distal end of said effecter protrudes from said distal end of said open-bore type lumen;

said open-bore type lumen and said effecter, in said active configuration, are adapted to apply, by means of said source of suction, sufficient suction to at least a portion of the intima so as to displace the same from its natural orientation;

said effecter defines, in said active configuration, a volume bounded on at least one side by a portion of the intima of said vessel that is displaced from its natural orientation to an orientation in which said guide wire will penetrate said intima and reenter said vessel;

wherein at least a portion of said distal end of said effecter, in said active configuration, protrudes out of said distal end of said open-bore type lumen and is at least partially buckled in the direction of said proximal end of said open-bore type lumen while at least partially encircling at least part of the outer circumference of said distal end of said catheter so as to force apart tissue layers of a wall of the vessel to provide said volume.

It is another object of the present invention to provide the catheter as defined above, wherein at least a portion of said distal end of said effecter, is, when in said active configuration, at least partially buckled in the direction of said proxima; end of said lumen while at least partially encircling at least part of the outer circumference of said distal end of said catheter.

It is another object of the present invention to provide the catheter as defined above, wherein at least one of said effecters comprises a plurality of branches, such that reconfiguration of said branches from said inactive configuration to said active configuration results in said branches at least partially encircling said distal end of said catheter. It is another object of the present invention to provide the catheter as defined above, further comprising actuating means for actuating the reconfiguration of said effecter between said active and inactive configurations.

It is another object of the present invention to provide the catheter as defined above, wherein said actuating means is selected from the group consisting of magnetic means, heat means, electric means, mechanical means, and any combination thereof.

It is another object of the present invention to provide the catheter as defined above, wherein said actuating means additionally comprises means for moving said distal end of said effecter in and out of said lumen.

It is another object of the present invention to provide the catheter as defined above, wherein said actuating mechanism comprises at least one wire mechanically connected to said effecter.

It is another object of the present invention to provide the catheter as defined above, wherein said distal end of said effecter is open.

It is another object of the present invention to provide the catheter as defined above, wherein the area of the cross-section of said effecter as measured in the plane perpendicular to the longitudinal axis of said catheter varies along said main longitudinal axis of said catheter.

It is another object of the present invention to provide the catheter as defined above, wherein the area of the cross-section of said effecter as measured in the plane perpendicular to the longitudinal axis of said catheter increases along said main longitudinal axis of said catheter.

It is another object of the present invention to provide the catheter as defined above, wherein, when said effecter is in said active configuration, the cross-sectional area of at least a portion of said part of said effecter that protrudes from said catheter, as measured in a plane perpendicular to said longitudinal axis of said catheter, is greater than the cross-sectional area of said catheter as measured in a plane perpendicular to said longitudinal axis of said catheter.

It is another object of the present invention to provide the catheter as defined above, wherein at least a portion of said proximal end of said effecter comprises a plurality of dispersed wire branches.

It is another object of the present invention to provide the catheter as defined above, wherein said effecter, when in said inactive configuration, is disposed within said catheter, and further wherein the walls of said lumen constrain said effecter from reconfiguration to said active configuration. It is another object of the present invention to provide the catheter as defined above, wherein the shape of at least a portion of said proximal end of said effecter is selected from the group consisting of at least one curled wire, at least one wire with a zigzag shape, at least one wire with a spring-like shape, and any combination thereof.

It is another object of the present invention to provide the catheter as defined above, wherein said guide wire has a sharpened tip.

It is another object of the present invention to provide the catheter as defined above, wherein at least a portion of said distal end of said effecter comprises, when said effecter is in said active configuration, a plurality of loops substantially parallel to each other and substantially perpendicular to said longitudinal axis of said catheter.

It is another object of the present invention to provide the catheter as defined above, wherein at least two of said loops are physically attached to each other in at least one location.

It is another object of the present invention to provide the catheter as defined above, wherein said effecter is disposed outside of said lumen when it is in said inactive configuration.

It is another object of the present invention to provide the catheter as defined above, further comprising actuating means for reversibly moving said effecter along and around said main longitudinal axis of said catheter.

It is another object of the present invention to provide the catheter as defined above, wherein said source of suction provides sufficient suction such that, when said effecter is in said active configuration and suction is applied, said effecter is fixed against the inner surface of said vessel, so as to enable said guide wire to reenter said lumen, thereby bypassing said occlusion.

It is another object of the present invention to provide the catheter as defined above, wherein at least a portion of said effecter is made of a material chosen from the group consisting of materials having shape memory properties, electroactive polymers (EAPs), and any combination thereof.

It is another object of the present invention to provide the catheter as defined above, wherein said material having shape memory properties is selected from the group consisting of copper-based alloys, NiTi-based materials, and any combination thereof.

It is another object of the present invention to provide the catheter as defined above, wherein said EAP is of a type selected from the group consisting of dielectric EAPs, ferroelectric polymers, liquid crystalline polymers, ionic EAPs, and any mixture thereof. It is another object of the present invention to provide the catheter as defined above, wherein said guide wire is provided with an articulation mechanism.

It is another object of the present invention to provide the catheter as defined above, additionally comprising verification means for verifying the location at which said guide wire has penetrated said intima.

It is another object of the present invention to provide the catheter as defined above, wherein said verification means are chosen from the group consisting of a contrast agent, observation of blood passing through a hole about the point of penetration of said intima by said guide wire and any combination thereof.

It is another object of the present invention to provide the catheter as defined above, additionally comprising at least one marker at the distal end of at least one selected from a group consisting of said guide wire, said lumen, said catheter, said effecter and any combination thereof.

It is another object of the present invention to provide the catheter as defined above, wherein said at least one marker is adapted to indicate the relative position of at least one selected from a group consisting of said guide wire, said lumen, said catheter, and said effecter; with respect to at least one selected from a group consisting of said guide wire, said lumen, said catheter, and said effecter.

It is another object of the present invention to provide the catheter as defined above, additionally comprising at least one marker disposed at the distal end of said catheter, adapted to indicate the full reconfiguration of said effecter from said inactive configuration to said active configuration.

It is another object of the present invention to provide the catheter as defined above, wherein said reconfiguration of said effecter from said inactive configuration to said active configuration is provided by means selected from (a) pulling said catheter in said proximal direction; pushing said effecter in said distal direction.

It is another object of the present invention to provide the catheter as defined above, additionally comprising at least one marker at the distal end of at least one selected from a group consisting of said guide wire, said lumen, said catheter, said effecter and any combination thereof, adapted to indicate the position of at least one selected from a group consisting of said guide wire, said lumen, said catheter, said effecter and any combination thereof with respect to said vessel or said intima. It is another object of the present invention to provide the catheter as defined above, wherein said catheter is provided with a mechanism adapted to enable linear movement along said main longitudinal axis of at least one selected from a group consisting of said guide wire, said effecter and any combination thereof with respect to at least one selected from a group consisting of said guide wire, said effecter and any combination thereof.

It is another object of the present invention to provide the catheter as defined above, wherein said effecter is a stent-like effecter, a bagel shape braded effecter, cone shaped effecter.

It is another object of the present invention to provide the catheter as defined above, wherein said effecter is adapted to prevent collapse of tissue into its inner space.

It is another object of the present invention to provide the catheter as defined above, wherein said at least a portion of said distal end of said effecter is about 10% of the total length of said effecter.

It is another object of the present invention to provide the catheter as defined above, wherein at least one of said effecters comprises at least two branches, such that reconfiguration of all of said branches from said inactive configuration to said active configuration results in the at least partially encircling at least part of the outer circumference of said distal end of said catheter.

It is another object of the present invention to provide the catheter as defined above, wherein at least a portion of said distal end of said effecter comprises n dispersed wired branches, where n is an integer greater than 1.

It is another object of the present invention to provide the catheter as defined above, wherein at least a portion of said distal end of said effecter is characterized by either a symmetric or asymmetric shape with regards to said main longitudinal axis of said lumen.

It is another object of the present invention to provide the catheter as defined above, wherein said effecter, in said inactive configuration, is maintained within said lumen such that the same is constrained to its shape by mean of said lumen.

It is another object of the present invention to provide the catheter as defined above, wherein the shape of at least a portion of said distal end of said effecter is selected from a group consisting of a curled wire, a spring-like shape, spiral-like shape, helix, coil, spiral, sphere, cone, cylinder, egg-like, loop-like, ball-like, ovoid-like, globular-like, globe-like, orbicular- like, polygonal having n ribs, n is an integer greater than 2, and any combination thereof.

It is another object of the present invention to provide the catheter as defined above, wherein said effecter is characterized by having a tapered shape, adapted to facilitate advancing, penetrating, anchoring, piercing, crossing or otherwise actuating of the catheter within the occlusion.

It is another object of the present invention to provide the catheter as defined above, wherein said guide-wire is characterized by a sharpened tip adapted to puncture the intina so as to reenter the vessel.

It is another object of the present invention to provide the catheter as defined above, wherein at least a portion of said distal end of said effecter is characterized by a cross section selected form a group consisting of circular, triangle, rectangular, oval or any combination thereof.

It is another object of the present invention to provide the catheter as defined above, wherein said distal end of said effecter is adapted to define, in said inactive configuration, a volume throughout which said guide-wire is adapted to penetrate the intima at said occlusion proximal end and performs reentry at said lumen at said occlusion's distal end thereby crosses said occlusion.

It is another object of the present invention to provide the catheter as defined above, wherein said effecter is characterized by a spring-like mechanical behavior.

It is another object of the present invention to provide the catheter as defined above, wherein said spring is characterized by either a constant or a variant pitch.

It is another object of the present invention to provide the catheter as defined above, wherein said spring comprises n loops, said n is an integer greater than 1.

It is another object of the present invention to provide the catheter as defined above, wherein said loops are characterized by a constant radius, R.

It is another object of the present invention to provide the catheter as defined above, wherein said loops are characterized by either an increasing radius R, decreasing radius R or any combination thereof radius. It is another object of the present invention to provide the catheter as defined above, wherein said catheter further comprises a vacuum generating mechanism (V GM) adapted to stabilize and fix said effecter in said active configuration within said inner surface of said vessel, to enable said guide wire to penetrate the intima at said occlusion proximal end and to perform reentry at said lumen at said occlusion's distal end so as to by-pass/cross said occlusion.

It is another object of the present invention to provide the catheter as defined above, wherein said VGM is adapted for generating an effective measure of vacuum and introducing the vacuum towards said distal end of said catheter, via at least a portion of said lumen.

It is another object of the present invention to provide the catheter as defined above, wherein said guide-wire is characterized by a proximal end and a distal end, said proximal end of said guide-wire is characterized by at least one configuration selected from a group consisting of (a) a flexible tip; (b) a stiff tip; (c) a bent tip;(d) a sharpened tip; and any combination thereof.

It is another object of the present invention to provide a method for bypassing an occlusion in a vessel of a patient, comprising:

a. providing a catheter as defined above;

b. inserting said catheter into said vessel;

c. reconfiguring said effecter into said active configuration at a location distal to the distal end of said occlusion, at a location desired for reeenty, thereby defining a volume bounded at least partially by said effecter and by a portion of the intima of said vessel at least part of which is distal to said distal end of said occlusion;

d. applying sufficient suction to at least a portion of the intima so as to displace the same from its natural orientation;

e. extracting said guide wire out of said lumen;

f. penetrating the intima with said guide wire at a point within said portion of said intima that bounds said volume, thereby reentering into said vessel at a point distal to said distal end of said occlusion, bypassing said occlusion;

wherein said step of reconfiguring said effecter results in (a) the protruding of at least a portion of said distal end of said effecter out of said lumen; and, (b) at least partially buckling in the direction of said proximal end of said open-bore type lumen while at least partially encircling at least part of the outer circumference of said distal end of said catheter; thereby forcing apart tissue layers of a wall of the vessel to provide said volume and enabling said guide-wire to penetrate the intima and performing reentry so as to bypass said occlusion.

It is another object of the present invention to provide the method as defined above, further comprising a step of advancing said guide wire through said lumen.

It is another object of the present invention to provide the method as defined above, further comprising a step of reconfiguring the effecter into said inactive configuration.

It is another object of the present invention to provide the method as defined above, further comprising a step of removing said catheter form said vessel while leaving said guide wire within said vessel.

It is another object of the present invention to provide the method as defined above, further comprising a step of penetrating said intima of said vessel by said guide wire at a point proximal to said occlusion prior to said step of penetrating said intima of said vessel with said guide wire at a point distal to said occlusion.

It is another object of the present invention to provide the method as defined above, further comprising a step of introducing said catheter into said vessel at the point at which said guide wire reentered said vessel.

It is another object of the present invention to provide the method as defined above, further comprising at least one step chosen from the group consisting of (a) injecting a substance into said vessel and (b) visualizing said vessel.

It is another object of the present invention to provide the method as defined above, wherein said step of applying suction is initiated subsequent to said step of reconfiguring said effecter into its active configuration.

It is another object of the present invention to provide the method as defined above, wherein said step of applying suction comprises applying suction that is sufficiently strong to fix said effecter to said intima.

It is another object of the present invention to provide the method as defined above, further comprising a step of reconfiguring said effecter from said inactive configuration to said active configuration by means of an actuating means.

It is another object of the present invention to provide the method as defined above, wherein said step of reconfiguring said effecter from said inactive configuration to said active configuration by means of an actuating means additionally comprising at least one step selected from applying magnetic means, applying heat means, applying electrical means, applying mechanical means, and any combination thereof.

It is another object of the present invention to provide the method as defined above, wherein said step of reconfiguring said effecter from said inactive configuration to said active configuration by means of an actuating means additionally comprising step of linearly moving said distal end of said effecter in and out of said lumen.

It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said effecter with an area of the cross-section, as measured in the plane perpendicular to the longitudinal axis of said catheter, that varies along said main longitudinal axis of said catheter.

It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said effecter with an area of the cross-section, as measured in the plane perpendicular to the longitudinal axis of said catheter, that increases along said main longitudinal axis of said catheter.

It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said effecter, wherein, when said effecter is in said active configuration, the cross-sectional area of at least a portion of said part of said effecter that protrudes from said catheter, as measured in a plane perpendicular to said longitudinal axis of said catheter, is greater than the cross-sectional area of said catheter as measured in a plane perpendicular to said longitudinal axis of said catheter.

It is another object of the present invention to provide the method as defined above, additionally comprising step of reversibly moving said effecter along and around said main longitudinal axis of said catheter.

It is another object of the present invention to provide the method as defined above, wherein said step of applying suction additionally comprising step of providing sufficient suction such that, when said effecter is in said active configuration and suction is applied, said effecter is fixed against the inner surface of said vessel, so as to enable said guide wire to reenter said lumen, thereby bypassing said occlusion.

It is another object of the present invention to provide the method as defined above, additionally comprising step of providing at least a portion of said effecter from a material chosen from the group consisting of materials having shape memory properties, electroactive polymers (EAPs), and any combination thereof. It is another object of the present invention to provide the method as defined above, wherein said material having shape memory properties is selected from the group consisting of copper-based alloys, NiTi-based materials, and any combination thereof.

It is another object of the present invention to provide the method as defined above, wherein said EAP is of a type selected from the group consisting of dielectric EAPs, ferroelectric polymers, liquid crystalline polymers, ionic EAPs, and any mixture thereof.

It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said guide wire with an articulation mechanism.

It is another object of the present invention to provide the method as defined above, additionally comprising step of providing verification means for verifying the location at which said wire has penetrated said intima.

It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said verification means from the group consisting of a contrast agent, observation of blood passing through a hole about the point of penetration of said intima by said guide wire and any combination thereof.

It is another object of the present invention to provide the method as defined above, additionally comprising step of providing at least one marker at the distal end of at least one selected from a group consisting of said guide wire, said lumen, said catheter, said effecter and any combination thereof.

It is another object of the present invention to provide the method as defined above, additionally comprising step of indicating, by means of said at least one marker, the relative position of at least one selected from a group consisting of said guide wire, said lumen, said catheter, and said effecter; with respect to at least one selected from a group consisting of said guide wire, said lumen, said catheter, and said effecter.

It is another object of the present invention to provide the method as defined above, additionally comprising step of providing at least one marker disposed at the distal end of said catheter, to indicate the full reconfiguration of said effecter from said inactive configuration to said active configuration.

It is another object of the present invention to provide the method as defined above, wherein said step of reconfiguring said effecter from said inactive configuration to said active configuration is provided by means selected from (a) pulling said catheter in said proximal direction; pushing said effecter in said distal direction.

It is another object of the present invention to provide the method as defined above, additionally comprising step of providing at least one marker disposed at the distal end of at least one selected from a group consisting of said guide wire, said lumen, said catheter, said effecter and any combination thereof, adapted to indicate the position of at least one selected from a group consisting of said guide wire, said lumen, said catheter, said effecter and any combination thereof with respect to said vessel or said intima.

It is another object of the present invention to provide the method as defined above, wherein said step of reconfiguring said effecter further comprises:

a. buckling distally at least part of said effecter; and,

b. encircling at least partially the outer circumference of said proximal end of said catheter.

It is another object of the present invention to provide the method as defined above, further comprises a step of removing said catheter form said patient's vessel, and, optionally maintaining said guide- wire within said vessel.

It is another object of the present invention to provide the method as defined above, further comprises a step of performing reentry with said guide-wire while applying a suction mechanism.

It is another object of the present invention to provide the method as defined above, wherein said at least a portion of said distal end of said effecter is about 10% of the total length of said effecter.

It is another object of the present invention to provide the method as defined above, further comprises step of providing at least one of said effecters with at least two branches, such that reconfiguration of all of said branches from said inactive configuration to said active configuration results in the at least partially encircling at least part of the outer circumference of said distal end of said catheter.

It is another object of the present invention to provide the method as defined above, wherein said distal end of said effecter is open.

It is another object of the present invention to provide the method as defined above, wherein at least a portion of said distal end of said effecter comprises n dispersed wired branches, where n is an integer greater than 1.

It is another object of the present invention to provide the method as defined above, wherein at least a portion of said distal end of said effecter is characterized by either a symmetric or asymmetric shape with regards to said main longitudinal axis of said lumen.

It is another object of the present invention to provide the method as defined above, wherein the shape of at least a portion of said distal end of said effecter is selected from a group consisting of a curled wire, a spring-like shape, spiral-like shape, helix, coil, spiral, sphere, cone, cylinder, egg-like, loop-like, ball-like, ovoid-like, globular-like, globe-like, orbicular- like, polygonal having n ribs, n is an integer greater than 2, and any combination thereof.

It is another object of the present invention to provide the method as defined above, wherein at least a portion of said distal end of said effecter comprises n loops substantially parallel to each other, where said n is an integer greater than 1.

It is another object of the present invention to provide the method as defined above, wherein at least two of said loops are interconnected to each other in at least one location.

It is another object of the present invention to provide the method as defined above, wherein at least a portion of said distal end of said effecter is characterized by a cross section selected form a group consisting of circular, triangle, rectangular, oval or any combination thereof.

It is another object of the present invention to provide the method as defined above, wherein said proximal end of said effecter is adapted to define, in said inactive configuration, a volume throughout which said guide-wire penetrates the intima so as to by-pass/cross said occlusion and reenter the vessel.

It is another object of the present invention to provide the method as defined above, wherein said catheter further comprises a vacuum generating mechanism (V GM) adapted to stabilize and fix said effecter in said active configuration within said inner surface of said vessel, to enable said guide wire to reenter said lumen distally to the occlusion.

It is another object of the present invention to provide the method as defined above, wherein said VGM is adapted for generating an effective measure of vacuum and introducing the vacuum towards said distal end of said catheter, via at least a portion of said lumen. It is another object of the present invention to provide the method as defined above, wherein said effecter is adapted, in said active configuration, to provide said vessel with a predetermined void volume, defined by means selected from a group consisting of said effecter, said distal end of said catheter, the inner surface of said occlusion and any combination thereof.

It is another object of the present invention to provide the method as defined above, wherein said guide-wire is characterized by a distal end and a distal end, said proximal end of said guide-wire is characterized by at least one configuration selected from a group consisting of (a) a flexible tip; (b) a stiff tip; (c) a bent tip;(d) a sharpened tip; and any combination thereof.

It is another object of the present invention to provide the method as defined above, further comprising step of advancing guide wire either straight or bent tip in the direction of the lumen in order to puncture the intima of said vessel in order to gain access to the lumen.

It is another object of the present invention to provide the method as defined above, further comprising step of removing said catheter and continuing the procedure with said guide-wire.

It is another object of the present invention to provide the method as defined above, wherein said step of reconfiguring said effecter further comprises a step of actuating by a reciprocate movement of said pusher by maneuvering a pushing wire along and around the main longitude axis of said at least one lumen.

It is another object of the present invention to provide the method as defined above, wherein said effecter is is characterized by having a tapered shape, adapted to facilitate advancing, penetrating, anchoring, piercing, crossing or otherwise actuating of the catheter within the occlusion.

It is another object of the present invention to provide the method as defined above, wherein said guide-wire is characterized by a sharpened tip adapted to puncture said occlusion and of the layers of the vessel.

It is another object of the present invention to provide a device for bypassing an occlusion in a vessel comprising an elongated device body including:

(a) a channel configured for accommodating a guidewire therethrough; and

(b) a distal portion being configured for: (i) forcing apart tissue layers of a wall of the vessel to thereby angle a portion of an inner layer of said tissue layers into a lumen of the vessel; and

(ii) pulling said portion of said inner tissue layer against a distal end of said elongated device body;

thereby enabling a guide-wire advanced through said central channel and out of said distal end to puncture through said inner tissue layer and into said lumen of the vessel downstream of the occlusion.

It is another object of the present invention to provide the device as defined above, wherein said distal portion includes an effecter being expandable to force apart said tissue layers of said wall when positioned therebetween.

It is another object of the present invention to provide the device as defined above, wherein (ii) is effected via suction.

It is another object of the present invention to provide the device as defined above, wherein said effecter is mechanically expandable.

It is another object of the present invention to provide the device as defined above, wherein said effecter includes at least one wire capable of forming said effecter when extended out of said elongated device body.

It is another object of the present invention to provide the device as defined above, wherein said at least one wire forms at least one coil, at least one loop, a basket or a half ball pre- shaped braid when extended out of said elongated device body.

It is another object of the present invention to provide the device as defined above, wherein said at least one loop includes a plurality of overlapping loops.

It is another object of the present invention to provide the device as defined above, wherein said at least one wire is composed of a shape memory material, selected from Nitinol.

It is another object of the present invention to provide the device as defined above, wherein said effecter forms a toroid, a cone or a ball when expanded.

It is another object of the present invention to provide the device as defined above, wherein said elongated device body is capable of articulation.

It is another object of the present invention to provide the device as defined above, wherein the vessel is an artery and said inner tissue layer is an intima.

It is another object of the present invention to provide the device as defined above, wherein a distal tip of said guide-wire is configured for puncturing tissue. It is another object of the present invention to provide the device as defined above, wherein said effecter is configured such that it curves towards said lumen when said tissue layers of said wall of the vessel are forced apart.

BRIEF DESCRIPTION OF THE FIGURES

In order to better understand the invention and its implementation in a practice, a plurality of embodiments will now be described, by a way of non-limiting example only, with reference to the accompanying drawings, in which

Fig. 1 schematically illustrates a catheter comprising an effecter with dispersed wired arms active configuration, according to certain embodiments of the present invention; Fig. 2A schematically illustrates a catheter comprising an effecter with a coiled shape active configuration; according to certain embodiments of the present invention;

Fig. 2B schematically illustrates a catheter comprising two effecters with a spring-like shaped active configuration; according to an embodiment of the present invention; Fig. 2C schematically illustrates a catheter comprising three effecters with a spring-like shaped active configuration; according to certain embodiments of the invention;

Fig. 3A schematically illustrates a catheter comprising an effecter with separated zig-zag shaped wires, according to some embodiments of the present invention; Fig. 3B schematically illustrates a top view of the effecter presented in Fig. 4 A.

Fig. 4 schematically illustrates an alternative active configuration of the effecter having loops interconnected in several locations, according to some preferred embodiments of the invention.

Fig. 5A schematically illustrates a catheter comprising an effecter having a helix- like active configuration, according to certain embodiments of the invention;

Fig. 5B schematically illustrates a preferred embodiment of the catheter of Fig. 5 A;

Fig.6 schematically illustrates a catheter comprising an effecter with diverged arms, according to some embodiments of the invention; and,

Fig. 7 schematically illustrates a catheter comprising an effecter comprising separate zig-zag shaped wires, constructing a hollow spherical like active configuration, according to certain embodiments of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The following description is provided, alongside all chapters of the present invention, so as to enable any person skilled in the art to make use of said invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modifications, however, will remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide catheter for crossing/bypassing occlusions in vessels of a patient.

The present invention provides a catheter for bypassing an occlusion in a vessel of a patient, said catheter comprising:

b. at least one guide wire, accommodated within said lumen, reciprocally maneuverable along and around said main longitudinal axis of said lumen; said guide-wire is adapted to penetrate the intima at said occlusion's proximal end and to puncture the intima at at said occlusion's distal end so as to perform reentry to said lumen and to bypass/cross said occlusion and;

said effecter defines, in said active configuration, a volume bounded on at least one side by a portion of the intima of said vessel that is displaced from its natural orientation to an orientation in which said guide wire will penetrate said intima and reenter said vessel

wherein at least a portion of said distal end of said effecter, in said active configuration, protrudes out of said distal end of said open-bore type lumen and is adapted to at least partially encircle at least part of the outer circumference of said distal end of said catheter so as to force apart tissue layers of a wall of the vessel to provide said volume.

Thus, it is within the core concept of the present invention to provide a catheter which comprises an effecter adapted to force apart tissue layers (in the subintimal space) so as to create a volume throughout which the guide-wire will puncture the intima (distally to the occlusion) and will reenter the blood vessel. Said volume is created by the effecter buckling backwards (towards the proximal side of the catheter) and at least partially encircling at least part of the outer circumference of said distal end of said catheter.

It is a main aspect of the invention that the catheter herein disclosed is adapted to treat patients with Chronic Total (arterial) Occlusion (CTO) conditions.

It is also within the scope of the present invention to provide a method for crossing an occlusion in vessels of a patient. The method comprises steps selected inter alia from: Providing at least one catheter adapted to cross occlusions in vessels of a patient having a distal end reversibly insertable within the occlusion and a proximal opposite end located outside the patient. The catheter also comprises at least one open-bore lumen provided in parallel to the main longitudinal axis of the catheter, having a distal end located at the distal end of the catheter, and a proximal end located outside the patient.

The catheter may also comprise at least one vacuum generating mechanism (V GM), being in a fluid communication with the lumen's distal end. The VGM is adapted for generating an effective measure of vacuum and introducing the vacuum in the distal end of the catheter, via a portion or an entire length of the lumen.

The catheter also comprises at least one movable effecter; adapted to be reversibly reciprocate, by means of an actuating mechanism, along and around the main longitudinal axis of the catheter.

The effecter is locatable between at least two configurations, a inactive configuration and an active configuration, in the active configuration, the distal end of the effecter is adapted to generate a volume between the intima and the blood vessel.

The effecter, in the active configuration, provides within the vessel a preset void volume defined by means of the effecter, the distal end of the catheter and the inner surface of the blood vessel (or alternatively the occlusion).

The effecter, in the active configuration, protrudes out of said distal end of said open-bore type lumen and is adapted to at least partially encircle at least part of the outer circumference of said distal end of said catheter.

The catheter also comprises at least one guide-wire, accommodated within the lumen, reciprocally maneuvered along and around the main longitudinal axis of the lumen.

The guide-wire is adapted for crossing/by-passing the occlusion; Crossing/by-passing the occlusion by the guide- wire is provided by adjacently bringing the catheter to a location as close as possible to the occlusion; Bringing\activating the effecter into the active configuration while keeping the effecter adjacent to the occlusion;

Stabilizing and fixing the effecter in the sub-intima space to the inner surface of the occlusion and/or to the inner surface of the vessel to enable the guide-wire to by-pass the occlusion (by means of the vacuum generating mechanism, VGM).

When the effecter is stabilized in the active configuration, the guide-wire is advanced and puncture the intima so as to renter the vessel and to crossing/by passing the occlusion.

As mentioned above, in this position, the effecter is stabilized and fixed to the inner surface of the occlusion and or to the inner surface of the vessel. Then, the intima of the vessel is punctured. Next, the guide wire is advanced either straight or bent in the direction of the lumen in order to puncture the intima (which is fixed to the effecter by suction) of the vessel in order to reenter the vessel;

Once the guide-wire had crossed the occlusion, the suction is terminated, the effected is reconfigured into the inactive configuration; the catheter is removed and the procedure continues with the guide-wire.

Alternatively, the catheter advances beyond the occlusion for injection and visualization before its removal; and, repeating at least one of the previous steps, if required.

Such effecters when protrudes out of the catheter provides mechanical support for the guide wire and enables the same to puncture the intima and to reentry said lumen at said occlusion's distal end so as to by-pass/cross the occlusion.

As used herein, the term "bore type lumen" refers in a non-limiting manner to a channel, conduit, pipe, tunnel, hole, barrel, passageway, facilitated space, or other cavity or channel with a tubular structure, adapted, i.e. by means of size and shape, to accommodate, according to certain embodiments, at least one of the following: at least a portion of the guide-wire, at least a portion of the effecter and at least a portion of an actuating mechanism.

The term "guide wire" used herein refers to a long and flexible fine spring or spring -like member, that may be used to introduce and position an intravascular angiographic catheter, usually used in the Seldinger technique.

As used herein, the term "distal" refers to a direction away from the operator (of the present device), and the term "proximal" to a direction toward the operator. Thus, as a non-limiting example, in treatment of an occlusion with the catheter disclosed herein, the distal end of the catheter (with guide- wire) enters the vessel wall at the proximal side of the occlusion and the guide-wire punctures back into the vessel lumen on the distal side of the occlusion thereby achieving the bypass.

The term "effecter" as used herein, refers in a non limiting manner to a member or actuator adapted to cause or achieve a result or to produce an outcome or to accomplish an effect.

According to preferred embodiments of the invention, such an effecter has an active configuration and an inactive configuration. In said active configuration, at least a portion of the at least one effecter preferably protrudes out of the distal end of the catheter so as to create a preset volume defined by said effecter, said blood vessel and said distal end of said catheter.

According to one embodiment, in the active configuration, at least a portion of the distal end of the effecter is preferably adapted, at least partially to encircle, surround, or enclose at least part of the outer circumference or outer rim of the distal end of the catheter. In another embodiment, the effecter is disposed in front or ahead of the distal end of the lumen. It is a core aspect of the invention that the distal end of the effecter is adapted to define or confine a void volume, throughout which the guide-wire by-passes the occlusion.

Catheters for bypassing occlusions in vessels (e.g. arteries) through the sub-intimal space are known in the art. Such catheters are designed to allow a guide- wire advanced therethrough to puncture the intima upstream of the occlusion, bypass the occlusion through a sub-intimal space and puncture out of the intima to re-enter the vessel lumen downstream of the occlusion. Initial puncturing of the intima and advancement of a guide-wire into the sub- intimal space is considered fairly straightforward, however, reentry into the vessel lumen can be challenging since it requires the 'creation' of a void volume throughout which the guide wire with puncture the intima and reenter the vessel. Such volume creation requires the both the creation of said space and the maintenance of the same. The present invention discloses such creation of void volume and the ability to maintain such volume so as to enable the guide wire to reenter the vessel so as to bypass the occlusion.

The term 'about' refers hereinafter to any value being ±25% of the defined measure.

The term "branch" used herein refers in a non limiting manner to an arm or limb or part, section or member of the at least one effecter.

The term "active configuration" used herein refers inter alia to an effective or operative disposition, arrangement, design, or structure of the at least one effecter that protrudes out of the distal end of the catheter. According to main embodiments of the invention the at least one effecter is designed to define a volume within the vessel throughout which the guide-wire bypasses the occlusion. The aforementioned active configuration is further adapted to prevent collapse of the inner tissues of the vessel to the interior space, so as to enable the guide wire to by pass the occlusion.

In one aspect of the invention, the active configuration of the at least one effecter includes a conformation in which at least a portion of the distal end of the at least one effecter is adapted to at least partially encircle or surround or enclose at least part of the outer circumference or outer rim of the distal end of the catheter.

In a further aspect of the invention, at least a portion of the distal end of the at least one effecter is adapted to be at least partially buckled towards the proximal end of the catheter whilst at least partially encircling at least part of the outer circumference of the distal end of said catheter.

The active configuration as herein disclosed may preferably include three dimensional conformations comprising loop-like, helix-like and coiled, curled, spiral, spring- like armlike, branch-like elements, structures or conformations or a combination thereof.

It is herein further disclosed that at least a portion of the at least one effecter in its active configuration has a conformation or shape selected from a group consisting of sphere, cone, cylinder, egg-like, loop-like, ball-like, ovoid-like, globular-like, globe-like, orbicular-like, polygonal having n ribs, n is an integer greater than 2, and any combination thereof.

According to certain embodiments of the invention, the effecter conforms or reconfigured into the active configuration by either passively or actively facilitated actuating mechanism.

The term "inactive configuration" used herein refers to a shape or conformation which is non functional or non active. It is herein disclosed that the inactive configuration of the effecter could be at least partially disposed within the lumen and thus the same is constrained by the lumen of the catheter; or at least partially located outside the lumen protruding out of the proximal end of the catheter.

The term "spring - like" used herein refers to an elastic object adapted to store mechanical energy or behavior. It is within the scope of the present invention that a spring like shape may be characterized by a constant or non constant (variant) pitch. In a further embodiment a spring like shape may be characterized by n loops, each of said loops is characterized by a constant radius R or alternatively by a varied radius R which decreases or increases with n. It is a further main aspect of the invention that at least a portion of the effecter is made of materials having shape memory properties.

The term 'shape memory properties' used herein refers to a material or alloy that "remembers" its shape, and can be returned to that shape after being deformed. Shape memory alloys have numerous applications in the medical and aerospace industries. According to certain embodiments of the invention, shape memory alloy materials may include, but are not limited to copper-zinc-aluminum-nickel, copper-aluminum-nickel, and nickel-titanium (NiTi) alloys or any other copper-based alloys, NiTi-based materials and mixtures thereof.

The term "Electroactive Polymers", or "EAPs" used herein refer to polymers that exhibit a change in size or shape when stimulated by an electric field. EAPs are characterized by the ability to substantially undergo deformation while sustaining large forces. Such materials are commonly used for actuators and sensors applications. It is within the scope of the invention that types of Electroactive Polymers may include, but are not limited to dielectric EAPs, Ferroelectric Polymers, Liquid Crystalline Polymers, Ionic EAPs and mixtures thereof.

The term "Dielectric EAPs" used herein refer to materials in which actuation is caused by electrostatic forces, optionally, between two electrodes which squeeze the polymer. Dielectric elastomers are capable of withstanding very high strains and are adapted to fundamentally being a capacitor that changes its capacitance when a voltage is applied, by allowing the polymer to compress in thickness and expand in area due to the electric field. Examples of Dielectric EAPs may include electrostrictive polymers and dielectric elastomers.

The term "Ferroelectric Polymers" used herein refer to a group of crystalline polar polymers that are also ferroelectric, meaning that they maintain a permanent electric polarization that can be reversed, or switched, in an external electric field. Ferroelectric polymers, such as polyvinylidene fluoride (PVDF), are used in acoustic transducers and electromechanical actuators because of their inherent piezoelectric response, and as heat sensors because of their inherent pyroelectric response.

The term "Liquid Crystalline Polymers" used herein refer to liquid crystalline polymers comprising mesogenic groups linked to each other by a flexible spacer. The mesogens within a backbone form the mesophase structure causing the polymer itself to adopt a conformation compatible with the structure of the mesophase. The direct coupling of the liquid crystalline order with the polymer conformation has given main-chain liquid crystalline elastomers a large amount of interest. The synthesis of highly oriented elastomers leads to have a large strain thermal actuation along the polymer chain direction with temperature variation resulting in unique mechanical properties and potential applications as mechanical actuators

The term "Ionic EAPs" used herein refer to EAPs in which actuation is caused by the displacement of ions inside the polymer. Examples of ionic EAPS are conductive polymers, ionic polymer-metal composites (IPMCs), and responsive gels. Yet another example is a Bucky gel actuator, which is a polymer-supported layer of polyelectrolyte material consisting of an ionic liquid sandwiched between two electrode layers consisting of a gel of ionic liquid containing single- wall carbon nanotubes.

The term "pitch" used herein refers to the distance from the center of one coil to the center of the adjacent coil in a spring or a helix—like shape.

According to certain embodiments of the invention, the aforementioned effecter is operatable to reconfigure between the inactive and active configurations by means of an actuating mechanism, preferably by a source of energy such as electric current, hydraulic pressure, pneumatic pressure, application of heat, application of magnetic field, application of mechanic means or any combination thereof.

It is within the core concept of the present invention to disclose a catheter as defined in any of the above, wherein at least a portion of the distal face of said effecter, can, when in the active configuration buckle (flatten) against the tissue.

It is within the core concept of the present invention to disclose a catheter as defined in any of the above, wherein the effecters wires branch such that expansion of the effector results in at least partial encircling of the distal end of said catheter.

The following disclosure provides a further detail on the catheter as being able to at least partially buckle in the proximal direction.

In one aspect of the invention, the active configuration of the at least one effecter includes a conformation in which at least a portion of the distal end of the at least one effecter is adapted to at least partially encircle or surround or enclose at least part of the outer circumference or outer rim of the distal end of the catheter. In a further aspect of the invention, at least a portion of the distal end of the at least one effecter is adapted to be at least partially buckled towards the proximal end of the catheter whilst at least partially encircling at least part of the outer circumference of the distal end of said catheter. In another aspect of the invention, the distal end of the at least one effecter, in its active configuration, is diverged in a non single-point assembled manner, such that the distal end of the effecter is open, or is assembled into a single point positioned at the distal end of the guide wire such that the distal end of the at least one effecter is converged to a single point. In both cases the distal end of the at least one effecter is located adjacent to the occlusion site within the vessel.

An active configuration as herein disclosed may preferably include three dimensional conformations comprising loop-like, helix-like and coiled, curled, spiral, spring-like, or branch-like elements, structures or conformations or a combination thereof. In some embodiments of the invention, at least a portion of the at least one effecter in its active configuration has a conformation or shape selected from a group consisting of sphere, cone, cylinder, egg-like, loop-like, ball-like, ovoid-like, globular-like, globe-like, orbicular-like, polygonal having n ribs, n is an integer greater than 2, and any combination thereof.

According to certain embodiments of the invention, the effecter conforms or reconfigured into the active configuration by an either passively or actively facilitated actuating mechanism.

In some embodiments of the invention, the inactive configuration of the effecter is at least partially disposed within the lumen and thus is constrained from reconfiguring into its active configuration by the lumen of the catheter. In other embodiments of the invention, in its inactive configuration, the effecter is at least partially located outside the lumen protruding out of the distal end of the catheter.

Reference is now made to the drawings showing preferred embodiments of the catheter having an effecter characterized by alternative active configuration conformations as optional examples of the present invention.

Reference is made now to FIG. 1, which illustrates schematically a catheter 10 comprising an effecter 40 with dispersed wired arms 45.

The term arm used herein also refers to a branch, a segment or a part of the effecter.

The catheter 10 is adapted to accommodate within its longitudinal lumen 20 a guide wire 30 and at least a portion of the effecter. In preferred embodiments of the invention, the catheter 10 has an external diameter of about 0.8-1.5 mm.

The lumen 20 has a diameter of approximately 0.014" (0.36 mm).

After insertion of the catheter adjacent to an occlusion within a vessel, the effecter is reconfigured from the inactive configuration to the active configuration so as to emerge from lumen 20 and hence from the catheter.

In other words, after emerging from the distal end of the catheter, the effecter assumes its active configuration. In the embodiment shown in FIG. 1, at least a portion of the distal end of the effecter comprises a plurality of dispersed wired arms 45. In the non-limiting example shown in the figure, the proximal end of the effecter comprises six wired arms 45.

In some embodiments of the invention, each of the wired arms comprises more than one segment 55.

Thus, by protruding out of the catheter's distal end, the effecter conforms into its active configuration. In this figure, at least a portion of the proximal end of the effecter comprises n dispersed wired arms 45, wherein n is an integer greater than 1. Specifically, the proximal end of the effecter comprises 6 wired arms 45.

In the active configuration, the arms are disposed so as to least partially encircle at least the distal end of the catheter.

In some embodiments of the invention, the wired arms are buckled or bent backwards towards the proximal end of the catheter 10. In some embodiments of the invention, in the inactive configuration, the wired arms are disposed within the lumen 20 but protrude from the lumen in the active configuration.

In some embodiments of the present invention, in the inactive configuration the wired arms protrude from of the lumen 20 and in the active configuration the wired arms buckle or bend backwards towards the proximal end of the catheter 10.

According to another embodiment of the present invention, once the wired arms protrude from the lumen 20 they can either be passively buckled or bent backwards or be actively buckled or bent backwards.

In the active buckling mode, an actuation mechanism activates the wired arms and reconfigures them from the initial configuration to the buckled configuration, in which said wired arms at least partially encircles or encloses at least a portion of the distal end of the catheter. In this mode the wired arms are made of material with elastic properties, such as shape memory alloys, EAPs or other materials with elastic or flexible elements.

In the passive buckling mode the wired arms are reconfigured from the initial configuration to the buckled configuration without use of an external actuation mechanism. This may be accomplished, for example, by having the wired arms being constructed such that they naturally assume the active configuration, but until the effecter exits the lumen, they are prevented from undergoing such expansion by the walls of the lumen. In this mode the wired arms are made of material with elastic properties, such as spring-like properties, shape memory alloys, EAPs or other materials with elastic or flexible elements. If the wired arms are made of, e.g., spring-like material, once they are extracted from lumen 20, the constraints of the lumen are removed and the wired arms buckle.

It is thus within the scope of the invention to provide an effecter made of a plurality of individual flexible wires 45 characterized by a spring-like characteristics.

Alternatively, the emergence of the effecter from the catheter can be facilitated by a pushing member 60 (in some embodiments, a wire) mechanically connected to the distal end of the effecter branches 45.

In another embodiment, the effecter is reconfigured into its active configuration by an active mechanism, for example by an actuating means.

As illustrated in Fig. 1, the wired arms of the effecter, in its active configuration are folded or curled backward, such that at least a portion of the distal ends of the arms encircle the distal end of the catheter. Such an active configuration is designed to define a volume through which the guide wire 30 can bypass the occlusion.

According to one embodiment, the effecter is made of at least one selected from a group consisting of copper-based alloy, NiTi-based materials, electro active polymers (EAPs and mixtures thereof. Thus, the activating mechanism which transforms the effecter from the active configuration to the inactive configuration and vice versa is selected from a group consisting of application of heat, application of electric current, application of magnetic field, application of mechanic means or any combination thereof.

As mentioned above the main advantages of the present invention is the fact that such effecters when protrude out of the catheter provides mechanical support for the guide wire and enables the same to puncture the mtima at said occlusion distal end and to perform reentry to said lumen so as to by-pass/cross the occlusion. Reference is now made to FIG. 2A, which illustrates schematically a catheter 10 comprising an effecter 40 with a coiled or spring like shaped wire. Once the effecter emerges from the distal end of the lumen 20, the distal end of the effecter 40 deforms into a coiled three dimensional conformation.

As shown in this figure, the effecter is reconfigured to a spring- like or curled shape with two helices or loop-like structures 42 that encircle at least a portion of the proximal part of the catheter in a symmetrical manner, with respect to the main longitudinal axis of the lumen.

In this configuration, a void volume or space is defined within the vessel, enabling the catheter accommodating the guide wire 30 to approach the occlusion such that the distal end of the guide wire at least partially extends from the distal end of lumen 20 and may puncture the intima at the distal end of the occlusion and to reenter the vessel, thereby bypassing the occlusion.

Reference is now made to Fig. 2B which schematically illustrates a catheter comprising two effecters with a spring-like shape as in Fig. 2a.

In this figure, each of the effecters 40 has a helical shape in its unconstrained active, encircling the distal part of the outer circumference of the catheter 10.

As illustrated in the figure, the two effecters comprise wires extending from the distal end of the lumen 20 of the catheter 10 that are tightly curled into a spring like configuration encircling the outer rim of the catheter 10 and providing the effecter with substantial mechanical strength, stabilizing and fixing the effecter in the inner surface of the vessel.

Effecters in the shape of springs with a constant pitch and those in the shape of springs with a variable pitch 47 are contemplated by the inventor as being within the scope of the invention.

In certain embodiments of the invention the spring-like configuration comprises a plurality of n loops 42, each of which is characterized by a radius R„. The radius may vary from loop to loop (i.e., in some embodiments, R_n≠ R_m for at least some values of m≠ n).

Alternatively, as shown in Fig. 2C, the catheter may comprise three separate effecters 40 characterized by three separate curled shaped wires protruding from the distal end of the lumen 20 of the catheter 10 and configured into a tightly coiled spring-like configuration encircling at least a portion of the outer rim of the catheter 10.

Reference is now made to Fig. 3 schematically illustrating an alternative embodiment of the present invention. In the figure, the effecter is shown in its active configuration. In the figure, the unconstrained effecter comprises three separate wired parts 45 or branches extruding out of the proximal end of the catheter 10.

In a preferred embodiment, at least a portion of the distal end of the wired arms is deformed into a Zig Zag shaped configuration at least partially encircling the distal part of the catheter 10.

As shown in FIG. 3A, the effecter may comprise more than one member (the three separate wired members illustrated in the figure exemplify one embodiment and are not intended to limit the invention). Each one of the effecter members deforms into its predetermined conformation upon emerging from the distal end of the lumen of the catheter, thereby forming a three dimensional structure enclosing the main longitudinal axis of the lumen, whereby the distal end of the effecter is directed towards the proximal end of the catheter 10.

Fig. 3B illustrates a top view of the effecter as described in Fig. 3A. The top view schematically presents the upper part of an embodiment in which the effecter is characterized by three sections 45 dispersed in three directions, encircling the outer borders of the catheter 10.

According to preferred embodiments of the invention, such an active configuration is adapted to form a defined volume within the vessel throughout which the guide wire 30 protrudes to bypass the occlusion.

Reference is now made to Fig. 4 schematically illustrating another embodiment of the effecter in its active configuration. The effecter shown in this figure comprises a plurality of n loops 80 encircling the outer circumference of the catheter 10. The loops are interconnected to each other in at least one location by wired elongated members 85 or buckled towards the distal end of the catheter 10.

Reference is now made to Fig. 5a, schematically illustrating a catheter comprising an effecter with a spring like active configuration 40. In Fig. 5A, the spring protrudes out of the distal end of the lumen 20, forming a spring-like shape being characterized by n helixes or loop like structures 42.

In one embodiment, the loops are characterized by a constant radius R. In another embodiment, the loops are characterized by radius which varies as a function of the position of the loop along the longitudinal axis of the effecter. Non-limiting examples of such a variable-radius effecter include a constantly increasing radius as one advances in the proximal direction, a constantly decreasing radius as one advances in the proximal direction, a radius that increases to a maximum and then decreases, etc. As illustrated in FIGs. 5a-5b, such an active configuration is adapted to define a volume throughout which the guide wire 30 can be moved.

As mentioned above, in some embodiments of the present invention, the effecter is characterized by an open distal end, as illustrated in Fig. 6a.

Reference is now made to FIG. 6A, which illustrates schematically a catheter comprising an effecter with wired elements 45 that have an open proximal end in the active configuration. In this active configuration, after emergence of the effecter from the catheter confines, the guide wire 30 is adapted to be insertable throughout the space or volume defined by the arm-like elements of the effecter, to enable the guide wire to penetrate the intima at the distal end of the occlusion reenter the vessel at the distal end of the occlusion, thereby bypassing the occlusion.

Reference is now made to Fig. 7 which schematically illustrates a catheter comprising an effecter comprising several segments or parts 45, each part forming a zigzag shaped active configuration.

It is within the scope of the invention that the wired segments define a hollow spherical or essentially spherical volume or space.

The wired segments protrude out of the distal end of the catheter 20, and are re-assembled into one location 100 positioned at the distal part of the guide wire 30, enabling the guide wire to bypass the occlusion. An actuating mechanism 70 is adapted to activate the effecter. In the embodiment illustrated in FIG. 7, the actuating mechanism 70 is simply a wire that reciprocally moves along the main longitudinal axis of the catheter such that the linear movement reconfigures the effecter 40 from its inactive configuration, in which the segments 45 are compressed and packed together; to the active configuration in which the segments 45 are deployed.

In some embodiments of the invention, the catheter has an outer diameter of between about 0.035" and about 0.052" (0.89 - 1.33 mm).

In some embodiments of the invention, the guide wire has a diameter of between about 0.008" and about 0.018" (0.2 - 0.46 mm). In another embodiment of the invention, the effecter is at least partially made of a shape memory alloy (e.g., Nitinol) with a front segment which, when unconstrained, takes on a three dimensional form to prevent collapse of tissue into its interior. One non-limiting example of a possible shape is a helix with a diameter similar to or somewhat larger than that of the guide wire or catheter. Other non-limiting examples of shapes that are within the scope of the invention include a variety of patterns creating a surface contour of a sphere, a cone, a cylinder or an egg-like form. The tip (front end) of the thin preformed spacing wire can be, for example, a sphere with a diameter which may be larger than that of the catheter, or it can be tightly curled up so that it does not have a sharp pointing tip, but rather an atraumatic one.

It is according to yet another embodiment of the invention to provide the catheter as defined above, wherein the effecter is characterized by having a tapered shape, adapted to facilitate advancing, penetrating, anchoring, piercing, crossing or otherwise actuating of the catheter within the occlusion.

It is according to yet another embodiment of the invention to provide the catheter as defined above, wherein the guide-wire is characterized by a sharpened tip adapted for puncturetion of the occlusion and of the layers of the vessel.

According to another embodiment of the present invention, the guide wire is provided with an articulation mechanism.

According to another embodiment of the present invention, the catheter additionally comprising verification means for verifying the location at which said guide wire has penetrated said intima.

According to another embodiment of the present invention, the verification means are chosen from the group consisting of a contrast agent, observation of blood passing through a hole about the point of penetration of said intima by said guide wire and any combination thereof.

According to another embodiment of the present invention, the catheter additionally comprising at least one marker at the distal end of at least one selected from a group consisting of said guide wire, said lumen, said catheter, said effecter and any combination thereof.

According to another embodiment of the present invention, the at least one marker is adapted to indicate the relative position of at least one selected from a group consisting of said guide wire, said lumen, said catheter, and said effecter; with respect to at least one selected from a group consisting of said guide wire, said lumen, said catheter, and said effecter. According to another embodiment of the present invention, the catheter additionally comprising at least one marker disposed at the distal end of said catheter, adapted to indicate the full reconfiguration of said effecter from said inactive configuration to said active configuration.

In some embodiments of the invention, at least one of the lumen and the catheter are articulated. As with the guide wire, the primary advantage of articulating one or both of the lumen and the catheter is that such articulation allows for more precise positioning of the distal end of the device in order to ensure that the guide wire will penetrate the tissue at the point desired by the operator. Any type of articulated catheter or lumen known in the art may be used.

In some embodiments of the invention, it additionally comprises means for verifying that the guide wire has penetrated the intima at the desired location. Such means are well-known in the art. In some embodiments of the invention, the verification means comprise a contrast agent that has been injected into the vessel. In other embodiments, the verification means comprise observation of blood exiting the vessel through a hole cut around the point at which the guide wire penetrates the intima. In preferred embodiments, following guide wire reentry into the vessel the hollow support element is advanced over the wire into the vessel, the wire is then removed from the catheter and once blood flows out of the catheter proximal end reentry is verified.

In some embodiments of the invention, at least one marker is placed on at least part of the effecter, the distal end of the catheter, the lumen, the hollow support element, or the guide wire. In embodiments in which the effecter comprises a plurality of components, a marker may be placed on each of them. The markers are used to enable the operator to determine the exact location of the distal end of the component of the system on which the marker has been placed. In addition, markers placed on the effecter enable the operator to determine directly whether the effecter is in its active or inactive configuration. Such markers are well known in the art. Non-limiting examples of markers useful in the present apparatus include visual markers (e.g. dye or paint), ultrasonic transducers, etc.

In another embodiment of the invention, the effecter is at least partially made of a shape memory alloy (e.g., Nitinol) with a front segment which, when unconstrained, takes on a three dimensional form to prevent collapse of tissue into its interior. One non-limiting example of a possible shape is a helix/coil with a diameter similar to or somewhat larger than that of the guide wire or catheter. Other non-limiting examples of shapes that are within the scope of the invention include a variety of patterns (mesh/basket) creating a three dimensional shape such as a toroid, a sphere, a cone, a cylinder or an ovoid. The tip (front end) of the thin preformed spacing wire can be, for example, a sphere with a diameter which may be larger than that of the catheter, or it can be tightly curled up so that it does not have a sharp pointing tip and thus would not cause trauma to surrounding tissues.

It is a further object of this invention to disclose a catheter as defined in any of the above, wherein the guide wire has a sharpened tip (e.g. beveled).

According to another embodiment of the present invention the reconfiguration of the effecter from the inactive configuration to the active configuration (and vice versa) is performed either actively or passively using an actuation mechanism.

As disclosed above, the actuating mechanism can be by e.g., application of magnetic force, application of heat, application of an electrical field, application of mechanical force (via cables/strut linkages) or any combination thereof.

Furthermore, it should be understood that passively reconfiguring the effecter from the inactive configuration to the active configuration (and vice versa) is provided by providing the effecter from materials such that when at least a portion of the distal end of the effecter protrudes from the distal end of the catheter it passively (i.e., without any external actuation from the user) reconfigures from inactive configuration to the active configuration.

In other words, in the passive reconfiguration of the effecter, when the effecter is maintain within the catheter, the effecter is constrained by the catheter; and, hence is maintained in the inactive configuration. When at least a portion of the effecter protrudes out of the catheter, the same is no longer constrained by the diameter of the catheter and hence can be converted to the active configuration.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.

Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.

Claims

1. A catheter for bypassing an occlusion in a vessel of a patient, comprising:

b. at least one guide wire, accommodated within said lumen, reciprocally maneuverable along and around said main longitudinal axis of said lumen; said guide-wire is adapted to penetrate the intima at said occlusion's proximal end and to puncture the intima at said occlusion's distal end so as to perform reentry to said lumen and to by-pass/cross said occlusion and,

c. at least one effecter having a distal end and a proximal end; characterized by at least one inactive configuration and at least one active configuration, said active configuration is characterized by at least a portion of the distal end of said effecter protruding from said distal end of said open-bore type lumen; said open-bore type lumen and said effecter, in said active configuration, are adapted to apply, by means of said source of suction, sufficient suction to at least a portion of the intima so as to displace the same from its natural orientation;

at least partially buckled in the direction of said distal end of said lumen while at least partially encircling at least part of the outer circumference of said proximal end of said catheter

2. The catheter according to claim 1, wherein at least a portion of said distal end of said effecter, is, when in said active configuration, at least partially buckled in the direction of said proxima; end of said lumen while at least partially encircling at least part of the outer circumference of said distal end of said catheter.

3. The catheter according to claim 1, wherein at least one of said effecters comprises a plurality of branches, such that reconfiguration of said branches from said inactive configuration to said active configuration results in said branches at least partially encircling said distal end of said catheter.

4. The catheter according claim 1, further comprising actuating means for actuating the reconfiguration of said effecter between said active and inactive configurations.

5. The catheter according to claim 4, wherein said actuating means is selected from the group consisting of magnetic means, heat means, electric means, mechanical means, and any combination thereof.

6. The catheter according to claim 4, wherein said actuating means additionally comprises means for moving said distal end of said effecter in and out of said lumen.

7. The catheter according to claim 4, wherein said actuating mechanism comprises at least one wire mechanically connected to said effecter.

8. The catheter according to claim 1, wherein said distal end of said effecter is open.

9. The catheter according to claim 1, wherein the area of the cross-section of said effecter as measured in the plane perpendicular to the longitudinal axis of said catheter varies along said main longitudinal axis of said catheter.

10. The catheter according to claim 1, wherem the area of the cross-section of said effecter as measured in the plane perpendicular to the longitudinal axis of said catheter increases along said main longitudinal axis of said catheter.

11. The catheter according to claim 1, wherein, when said effecter is in said active configuration, the cross-sectional area of at least a portion of said part of said effecter that protrudes from said catheter, as measured in a plane perpendicular to said longitudinal axis of said catheter, is greater than the cross-sectional area of said catheter as measured in a plane perpendicular to said longitudinal axis of said catheter.

12. The catheter according to claim 1, wherein at least a portion of said proximal end of said effecter comprises a plurality of dispersed wire branches.

13. The catheter according to claim 1, wherein said effecter, when in said inactive configuration, is disposed within said catheter, and further wherein the walls of said lumen constrain said effecter from reconfiguration to said active configuration.

14. The catheter according to claim 1, wherein the shape of at least a portion of said proximal end of said effecter is selected from the group consisting of at least one curled wire, at least one wire with a zigzag shape, at least one wire with a spring-like shape, and any combination thereof.

15. The catheter according to claim 1, wherein said guide wire has a sharpened tip.

16. The catheter according to claim 1, wherein at least a portion of said distal end of said effecter comprises, when said effecter is in said active configuration, a plurality of loops substantially parallel to each other and substantially perpendicular to said longitudinal axis of said catheter.

17. The catheter according to claim 16, wherein at least two of said loops are physically attached to each other in at least one location.

18. The catheter according to claim 1, wherein said effecter is disposed outside of said lumen when it is in said inactive configuration.

19. The catheter according to claim 1, further comprising actuating means for reversibly moving said effecter along and around said main longitudinal axis of said catheter.

20. The catheter according claim 1, wherein said source of suction provides sufficient suction such that, when said effecter is in said active configuration and suction is applied, said effecter is fixed against the inner surface of said vessel, so as to enable said guide wire to reenter said lumen, thereby bypassing said occlusion.

21. The catheter according to claim 1, wherein at least a portion of said effecter is made of a material chosen from the group consisting of materials having shape memory properties, electroactive polymers (EAPs), and any combination thereof.

22. The catheter according to claim 21, wherein said material having shape memory properties is selected from the group consisting of copper-based alloys, NiTi-based materials, and any combination thereof.

23. The catheter according to claim 21, wherein said EAP is of a type selected from the group consisting of dielectric EAPs, ferroelectric polymers, liquid crystalline polymers, ionic EAPs, and any mixture thereof.

24. The catheter according to claim 1, wherein said guide wire is provided with an articulation mechanism.

25. The catheter according to claim 1, additionally comprising verification means for verifying the location at which said guide wire has penetrated said intima.

26. The catheter according to claim 25, wherein said verification means are chosen from the group consisting of a contrast agent, observation of blood passing through a hole about the point of penetration of said intima by said guide wire and any combination thereof.

27. The catheter according to claim 1, additionally comprising at least one marker at the distal end of at least one selected from a group consisting of said guide wire, said lumen, said catheter, said effecter and any combination thereof.

28. The catheter according to claim 27, wherein said at least one marker is adapted to indicate the relative position of at least one selected from a group consisting of said guide wire, said lumen, said catheter, and said effecter; with respect to at least one selected from a group consisting of said guide wire, said lumen, said catheter, and said effecter.

29. The catheter according to claim 1, additionally comprising at least one marker disposed at the distal end of said catheter, adapted to indicate the full reconfiguration of said effecter from said inactive configuration to said active configuration.

30. The catheter according to claim 1, wherein said reconfiguration of said effecter from said inactive configuration to said active configuration is provided by means selected from (a) pulling said catheter in said proximal direction; pushing said effecter m said distal direction.

31. The catheter according to claim 1, additionally comprising at least one marker at the distal end of at least one selected from a group consisting of said guide wire, said lumen, said catheter, said effecter and any combination thereof, adapted to indicate the position of at least one selected from a group consisting of said guide wire, said lumen, said catheter, said effecter and any combination thereof with respect to said vessel or said intima.

32. The catheter according to claim 1, wherein said catheter is provided with a mechanism adapted to enable linear movement along said main longitudinal axis of at least one selected from a group consisting of said guide wire, said effecter and any combination thereof with respect to at least one selected from a group consisting of said guide wire, said effecter and any combination thereof.

33. The catheter according to claim 1, wherein said effecter is a stent-like effecter, a bagel shape braded effecter, cone shaped effecter.

34. The catheter according to claim 1, wherein said effecter is adapted to prevent collapse of tissue into its inner space.

35. The catheter according to claim 1, wherein said at least a portion of said distal end of said effecter is about 10% of the total length of said effecter.

36. The catheter according to claim 1, wherein at least one of said effecters comprises at least two branches, such that reconfiguration of all of said branches from said inactive configuration to said active configuration results in the at least partially encircling at least part of the outer circumference of said distal end of said catheter.

37. The catheter according to claim 1, wherein at least a portion of said distal end of said effecter comprises n dispersed wired branches, where n is an integer greater than 1.

38. The catheter according to claim 1, wherein at least a portion of said distal end of said effecter is characterized by either a symmetric or asymmetric shape with regards to said main longitudinal axis of said lumen.

39. The catheter according to claim 1, wherein said effecter, in said inactive configuration, is maintained within said lumen such that the same is constrained to its shape by mean of said lumen.

40. The catheter according to claim 1, wherein the shape of at least a portion of said distal end of said effecter is selected from a group consisting of a curled wire, a spring-like shape, spiral-like shape, helix, coil, spiral, sphere, cone, cylinder, egg-like, loop-like, ball-like, ovoid-like, globular-like, globe-like, orbicular-like, polygonal having n ribs, n is an integer greater than 2, and any combination thereof.

41. The catheter according to claim 1, wherein said effecter is characterized by having a tapered shape, adapted to facilitate advancing, penetrating, anchoring, piercing, crossing or otherwise actuating of the catheter within the occlusion.

42. The catheter according to claim 1, wherein said guide-wire is characterized by a sharpened tip adapted to puncture the intina so as to reenter the vessel.

43. The catheter according to claim 1, wherein at least a portion of said distal end of said effecter is characterized by a cross section selected form a group consisting of circular, triangle, rectangular, oval or any combination thereof.

44. The catheter according to claim 1, wherein said distal end of said effecter is adapted to define, in said inactive configuration, a volume throughout which said guide-wire is adapted to penetrate the intima at said occlusion proximal end and performs reentry at said lumen at said occlusion's distal end thereby crosses said occlusion.

45. The catheter according to claim 1, wherein said effecter is characterized by a spring-like mechanical behavior.

46. The catheter according to claim 45, wherein said spring is characterized by either a constant or a variant pitch.

47. The catheter according to claim 45, wherein said spring comprises n loops, said n is an integer greater than 1.

48. The catheter according to claim 45, wherein said loops are characterized by a constant radius, R.

49. The catheter according to claim 45, wherein said loops are characterized by either an increasing radius R, decreasing radius R or any combination thereof radius.

50. The catheter according to claim 1, wherein said catheter further comprises a vacuum generating mechanism (VGM) adapted to stabilize and fix said effecter in said active configuration within said inner surface of said vessel, to enable said guide wire to penetrate the intima at said occlusion proximal end and to perform reentry at said lumen at said occlusion's distal end so as to by-pass/cross said occlusion.

51. The catheter according to claim 50, wherein said VGM is adapted for generating an effective measure of vacuum and introducing the vacuum towards said distal end of said catheter, via at least a portion of said lumen.

52. The catheter according to claim 1, wherein said guide-wire is characterized by a proximal end and a distal end, said proximal end of said guide-wire is characterized by at least one configuration selected from a group consisting of (a) a flexible tip; (b) a stiff tip; (c) a bent tip;(d) a sharpened tip; and any combination thereof.

53. A method for bypassing an occlusion in a vessel of a patient, comprising:

a. providing a catheter as defined in claim 1;

b. inserting said catheter into said vessel;

e. extracting said guide wire out of said lumen;

54. The method according to claim 53, further comprising a step of advancing said guide wire through said lumen.

55. The method according to claim 53, further comprising a step of reconfiguring the effecter into said inactive configuration.

56. The method according to claim 53, further comprising a step of removing said catheter form said vessel while leaving said guide wire within said vessel.

57. The method according to claim 53, further comprising a step of penetrating said intima of said vessel by said guide wire at a point proximal to said occlusion prior to said step of penetrating said intima of said vessel with said guide wire at a point distal to said occlusion.

58. The method according to claim 53, further comprising a step of introducing said catheter into said vessel at the point at which said guide wire reentered said vessel.

59. The method according to claim 53, further comprising at least one step chosen from the group consisting of (a) injecting a substance into said vessel and (b) visualizing said vessel.

60. The method according to claim 53, wherein said step of applying suction is initiated subsequent to said step of reconfiguring said effecter into its active configuration.

61. The method according to claim 60, wherein said step of applying suction comprises applying suction that is sufficiently strong to fix said effecter to said intima.

62. The method according to claim 38, further comprising a step of reconfiguring said effecter from said inactive configuration to said active configuration by means of an actuating means.

63. The method according to claim 53, wherein said step of reconfiguring said effecter from said inactive configuration to said active configuration by means of an actuating means additionally comprising at least one step selected from applying magnetic means, applying heat means, applying electrical means, applying mechanical means, and any combination thereof.

64. The method according to claim 53, wherein said step of reconfiguring said effecter from said inactive configuration to said active configuration by means of an actuating means additionally comprising step of linearly moving said distal end of said effecter in and out of said lumen.

65. The method according to claim 53, additionally comprising step of providing said effecter with an area of the cross-section, as measured in the plane perpendicular to the longitudinal axis of said catheter, that varies along said main longitudinal axis of said catheter.

66. The method according to claim 53, additionally comprising step of providing said effecter with an area of the cross-section, as measured in the plane perpendicular to the longitudinal axis of said catheter, that increases along said main longitudinal axis of said catheter.

67. The method according to claim 53, additionally comprising step of providing said effecter, wherein, when said effecter is in said active configuration, the cross-sectional area of at least a portion of said part of said effecter that protrudes from said catheter, as measured in a plane perpendicular to said longitudinal axis of said catheter, is greater than the cross- sectional area of said catheter as measured in a plane perpendicular to said longitudinal axis of said catheter.

68. The method according to claim 53, additionally comprising step of reversibly moving said effecter along and around said main longitudinal axis of said catheter.

69. The method according to claim 53, wherein said step of applying suction additionally comprising step of providing sufficient suction such that, when said effecter is in said active configuration and suction is applied, said effecter is fixed against the inner surface of said vessel, so as to enable said guide wire to reenter said lumen, thereby bypassing said occlusion.

70. The method according to claim 53, additionally comprising step of providing at least a portion of said effecter from a material chosen from the group consisting of materials having shape memory properties, electroactive polymers (EAPs), and any combination thereof.

71. The method according to claim 70, wherein said material having shape memory properties is selected from the group consisting of copper-based alloys, NiTi-based materials, and any combination thereof.

72. The method according to claim 70, wherein said EAP is of a type selected from the group consisting of dielectric EAPs, ferroelectric polymers, liquid crystalline polymers, ionic EAPs, and any mixture thereof.

73. The method according to claim 53, additionally comprising step of providing said guide wire with an articulation mechanism.

74. The method according to claim 53, additionally comprising step of providing verification means for verifying the location at which said guide wire has penetrated said hitima.

75. The method according to claim 74, additionally comprising step of selecting said verification means from the group consisting of a contrast agent, observation of blood passing through a hole about the point of penetration of said intima by said guide wire and any combination thereof.

76. The method according to claim 53, additionally comprising step of providing at least one marker at the distal end of at least one selected from a group consisting of said guide wire, said lumen, said catheter, said effecter and any combination thereof.

77. The method according to claim 53, additionally comprising step of indicating, by means of said at least one marker, the relative position of at least one selected from a group consisting of said guide wire, said lumen, said catheter, and said effecter; with respect to at least one selected from a group consisting of said guide wire, said lumen, said catheter, and said effecter.

78. The method according to claim 53, additionally comprising step of providing at least one marker disposed at the distal end of said catheter, to indicate the full reconfiguration of said effecter from said inactive configuration to said active configuration.

79. The method according to claim 53, wherein said step of reconfiguring said effecter from said inactive configuration to said active configuration is provided by means selected from (a) pulling said catheter in said proximal direction; pushing said effecter in said distal direction.

80. The method according to claim 53, additionally comprising step of providing at least one marker disposed at the distal end of at least one selected from a group consisting of said guide wire, said lumen, said catheter, said effecter and any combination thereof, adapted to indicate the position of at least one selected from a group consisting of said guide wire, said lumen, said catheter, said effecter and any combination thereof with respect to said vessel or said intima.

81. The method according to claim 53, wherein said step of reconfiguring said effecter further comprises:

a. buckling distally at least part of said effecter; and,

82. The method according to claim 53, further comprises a step of removing said catheter form said patient's vessel, and, optionally maintaining said guide- ire within said vessel.

83. The method according to claim 53, further comprises a step of performing reentry with said guide-wire while applying a suction mechanism.

84. The method according to claim 53, wherein said at least a portion of said distal end of said effecter is about 10% of the total length of said effecter.

85. The method according to claim 53, further comprises step of providing at least one of said effecters with at least two branches, such that reconfiguration of all of said branches from said inactive configuration to said active configuration results in the at least partially encircling at least part of the outer circumference of said distal end of said catheter.

86. The method according to claim 53, wherem said distal end of said effecter is open.

87. The method according to claim 53, wherein at least a portion of said distal end of said effecter comprises n dispersed wired branches, where n is an integer greater than 1.

88. The method according to claim 53, wherein at least a portion of said distal end of said effecter is characterized by either a symmetric or asymmetric shape with regards to said main longitudinal axis of said lumen.

89. The method according to claim 53, wherein the shape of at least a portion of said distal end of said effecter is selected from a group consisting of a curled wire, a spring-like shape, spiral-like shape, helix, coil, spiral, sphere, cone, cylinder, egg-like, loop-like, balllike, ovoid-like, globular-like, globe-like, orbicular-like, polygonal having n ribs, n is an integer greater than 2, and any combination thereof.

90. The method according to claim 53, wherein at least a portion of said distal end of said effecter comprises n loops substantially parallel to each other, where said n is an integer greater than 1.

91. The method according to claim 90, wherein at least two of said loops are interconnected to each other in at least one location.

92. The method according to claim 53, wherein at least a portion of said distal end of said effecter is characterized by a cross section selected form a group consisting of circular, triangle, rectangular, oval or any combination thereof.

93. The method according to claim 53, wherein said proximal end of said effecter is adapted to define, in said inactive configuration, a volume throughout which said guide-wire penetrates the intima so as to by-pass/cross said occlusion and reenter the vessel.

94. The method according to claim 53, wherein said catheter further comprises a vacuum generating mechanism (VGM) adapted to stabilize and fix said effecter in said active configuration within said inner surface of said vessel, to enable said guide wire to reenter said lumen distally to the occlusion.

95. The method according to claim 94, wherein said VGM is adapted for generating an effective measure of vacuum and introducing the vacuum towards said distal end of said catheter, via at least a portion of said lumen.

96. The method according to claim 53, wherein said effecter is adapted, in said active configuration, to provide said vessel with a predetermined void volume, defined by means selected from a group consisting of said effecter, said distal end of said catheter, the inner surface of said occlusion and any combination thereof..

97. The method according to claim 53, wherein said guide- wire is characterized by a distal end and a distal end, said proximal end of said guide-wire is characterized by at least one configuration selected from a group consisting of (a) a flexible tip; (b) a stiff tip; (c) a bent tip;(d) a sharpened tip; and any combination thereof.

98. The method according to claim 53, further comprising step of advancing guide wire either straight or bent tip in the direction of the lumen in order to puncture the intima of said vessel in order to gain access to the lumen.

99. The method according to claim 53, further comprising step of removing said catheter and continuing the procedure with said guide- wire.

100. The method according to claim 53, wherein said step of reconfiguring said effecter further comprises a step of actuating by a reciprocate movement of said pusher by maneuvering a pushing wire along and around the main longitude axis of said at least one lumen.

101. The method according to claim 53, wherein said effecter is is characterized by having a tapered shape, adapted to facilitate advancing, penetrating, anchoring, piercing, crossing or otherwise actuating of the catheter within the occlusion.

102. The method according to claim 53, wherein said guide-wire is characterized by a sharpened tip adapted to puncture said occlusion and of the layers of the vessel.

103. A device for bypassing an occlusion in a vessel comprising an elongated device body including:

(a) a channel configured for accommodating a guidewire therethrough; and

104. The device of claim 103, wherein said distal portion includes an effecter being expandable to force apart said tissue layers of said wall when positioned therebetween.

105. The device of claim 103, wherein (ii) is effected via suction.

106. The device of claim 104, wherein said effecter is mechanically expandable.

107. The device of claim 106, wherein said effecter includes at least one wire capable of forming said effecter when extended out of said elongated device body.

108. The device of claim 107, wherein said at least one wire forms at least one coil, at least one loop, a basket or a half ball pre-shaped braid when extended out of said elongated device body.

109. The device of claim 108, wherein said at least one loop includes a plurality of overlapping loops.

110. The device of claim 109, wherein said at least one wire is composed of a shape memory material, selected from Nitinol.

111. The device of claim 104, wherein said effecter forms a toroid, a cone or a ball when expanded.

112. The device of claim 103, wherein said elongated device body is capable of articulation.

113. The device of claim 103, wherein the vessel is an artery and said inner tissue layer is an intima.

114. The device of claim 103, wherein a distal tip of said guide- wire is configured for puncturing tissue.

115. The device of claim 104, wherein said effecter is configured such that it curves towards said lumen when said tissue layers of said wall of the vessel are forced apart.