Patent Description:
Due to age, high cholesterol and other contributing factors, a large percentage of the population has arterial atherosclerosis that totally occludes portions of the patient's vasculature and presents significant risks to patient health. For example, in the case of a total occlusion of a coronary artery, the result may be painful angina, loss of cardiac tissue or patient death. In another example, complete occlusion of the femoral and/or popliteal arteries in the leg may result in limb threatening ischemia and limb amputation.

Commonly known endovascular devices and techniques are either inefficient (time consuming procedure), have a high risk of perforating a vessel (poor safety) or fail to cross the occlusion (poor efficacy). Physicians currently have difficulty visualizing the native vessel lumen, can not accurately direct endovascular devices toward the visualized lumen, or fail to advance devices through the lesion. Bypass surgery is often the preferred treatment for patients with chronic total occlusions, but less invasive techniques would be preferred.

<CIT> discloses devices and methods for exploiting intramural (e.g., subintimal) space of a vascular wall to facilitate the treatment of vascular disease, particularly total occlusions. For example, the devices and methods may be used to visually define the vessel wall boundary, protect the vessel wall boundary from perforation, bypass an occlusion, and/or remove an occlusion.

<CIT> discloses methods and apparatus for crossing totally to substantially occluded blood vessels by passing a redirectable wire such as a guidewire from a relatively proximal point past the occlusion within a subintimal space formed between the intimal layer and the adventitial layer of a blood vessel wall. The wire may be advanced to a point distal to the occlusion, and thereafter deflected back into the blood vessel lumen, typically using a deflecting catheter which is advanced over the guidewire after it has been positioned within the subintimal space. The deflecting catheter may include a flapper valve assembly or preformed actuator wire for redirecting the guidewire. After the guidewire is returned to the blood vessel lumen, the deflecting catheter may be withdrawn, and the guidewire may be available for introduction of other interventional and diagnostic catheters for performing procedures such as stenting.

Described herein are devices and methods employed to exploit the vascular wall of a vascular lumen for the purpose of bypassing a total occlusion of an artery. Exploitation of a vascular wall may involve the passage of an endovascular device into and out of said wall which is commonly and interchangeable described as false lumen access, intramural access, submedial access or in the case of this disclosure, subintimal access.

Described herein are devices and methods employed to exploit the vascular wall of a vascular lumen for the purpose of bypassing a total occlusion of an artery. Exploitation of a vascular wall may involve the passage of an endovascular device into and out of said wall which is commonly and interchangeable described as false lumen access, intramural access, submedial access or in the case of this disclosure, subintimal access.

In one aspect, the present disclosure is directed towards a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method may include providing a first intravascular device having a distal portion and at least one aperture and positioning the distal portion of the first intravascular device in the vascular wall. The method may further include providing a reentry device having a body and a distal tip, the distal tip having a natural state and a compressed state and inserting the distal tip, in the compressed state, in the distal portion of the first intravascular device. The method may further include advancing the distal tip, in the natural state, through the at least one aperture of the first intravascular device.

In another aspect, the present disclosure is directed towards an apparatus for facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The apparatus may include a first intravascular device having a distal portion, the distal portion including at least one aperture, at least one radiopaque marker, and at least one orienting element. The apparatus may further include a reentry device having a body and a distal tip, the distal tip having a natural state and a compressed state.

Additional objects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the invention and together with the description, serve to explain the principles of the invention.

Reference will now be made in detail to the present embodiments of the invention, examples of which are illustrated in the accompanying drawings.

<FIG> is a cross-sectional view of an artery <NUM> having a wall <NUM>. In <FIG>, wall <NUM> of artery <NUM> is shown having three layers. The outermost layer of wall <NUM> is the adventitia <NUM> and the innermost layer of wall <NUM> is the intima <NUM>. The tissues extending between intima <NUM> and adventitia <NUM> may be collectively referred to as the media <NUM>. For purposes of illustration, intima <NUM>, media <NUM> and adventitia <NUM> are each shown as a single homogenous layer in <FIG>. In the human body, however, the intima and the media each comprise a number of sublayers. The transition between the external most portion of the intima and the internal most portion of the media is sometimes referred to as the subintimal space. Intima <NUM> defines a true lumen <NUM> of artery <NUM>. In <FIG>, an occlusion <NUM> is shown blocking true lumen <NUM>. Occlusion <NUM> divides true lumen <NUM> into a proximal segment <NUM> and a distal segment <NUM>. In <FIG>, a distal portion of a guidewire <NUM> is shown extending into proximal segment <NUM> of true lumen <NUM>.

As shown in <FIG>, methods described in this document may include the step of advancing a guidewire to a location proximate an occlusion in a blood vessel. The exemplary methods described in this document may also include the step of advancing guidewire <NUM> between occlusion <NUM> and adventitia <NUM>. In some cases, however, the nature of the occlusion and the blood vessel will be such that the guidewire is unlikely to advance beyond the occlusion.

<FIG> is an additional view of artery <NUM> shown in the previous figure. In the embodiment of <FIG>, a crossing device <NUM> has been advanced over guidewire <NUM> so that a distal portion of crossing device <NUM> is disposed in proximal segment <NUM> of true lumen <NUM>. Crossing device <NUM> may be used to establish a channel between proximal segment <NUM> and distal segment <NUM>. Crossing device <NUM> of <FIG> comprises a tip <NUM> that is fixed to a distal end of a shaft <NUM>. As shown in <FIG>, methods described in this document may include the step of advancing a crossing device over a guidewire.

<FIG> is an additional view of artery <NUM> shown in the previous figure. In the embodiment of <FIG>, the distal end of crossing device <NUM> has been advanced in a distal direction so that tip <NUM> is adjacent to occlusion <NUM>. With reference to <FIG>, it will be appreciated that tip <NUM> has passed through intima <NUM> and is disposed between occlusion <NUM> and adventitia <NUM> of artery <NUM>. Some methods described in this document may include the step of advancing a crossing device between an occlusion and the adventitia of an artery.

<FIG> is an additional view of artery <NUM> and crossing device <NUM> shown in the previous figure. In the embodiment of <FIG>, the distal end of crossing device <NUM> has been advanced in an axial direction past occlusion <NUM>. Accordingly, it will be appreciated that methods described in this document may include the step of advancing a crossing device beyond an occlusion.

In the embodiment of <FIG>, crossing device has crossed occlusion <NUM> by advancing between occlusion <NUM> and adventitia <NUM> of artery <NUM>. It is to be appreciated that other methods of crossing an occlusion are within the scope of this disclosure. For example, the crossing device <NUM> may pass through occlusion <NUM> while remaining disposed inside true lumen <NUM>.

In <FIG>, tip <NUM> of crossing device <NUM> is shown residing between intima <NUM> and adventitia <NUM> of artery <NUM>. As tip <NUM> moves in an axial direction between intima <NUM> and adventitia <NUM>, tip <NUM> may cause blunt dissection of the layers forming the wall of artery <NUM>. Alternatively, tip <NUM> may cause blunt dissection of the materials comprising the occlusion <NUM>.

In some useful methods in accordance with the present disclosure, crossing device <NUM> is rotated about its longitudinal axis and moved in a direction parallel to its longitudinal axis simultaneously. When this is the case, rotation of crossing device <NUM> may reduce resistance to the axial advancement of crossing device <NUM>. These methods take advantage of the fact that the kinetic coefficient of friction is usually less than the static coefficient of friction for a given frictional interface. Rotating crossing device <NUM> assures that the coefficient of friction at the interface between the crossing device and the surround tissue will be a kinetic coefficient of friction and not a static coefficient of friction.

With reference to <FIG>, it will be appreciated that crossing device <NUM> extends past occlusion <NUM>. In <FIG>, occlusion <NUM> is shown blocking a true lumen <NUM>. Occlusion <NUM> divides true lumen <NUM> into a proximal segment <NUM> and a distal segment <NUM>. When a crossing device in accordance with some embodiments of the present disclosure is advanced through the subintimal space of an artery, the distal end of the crossing device may penetrate the intima and enter the distal segment of the true lumen after advancing beyond an occlusion. When this is the case, fluid communication between the proximal segment and the distal segment may be achieved via a channel created by the crossing device.

<FIG> is an additional view of artery <NUM> shown in the previous figure. In the embodiment of <FIG>, crossing device <NUM> has been withdrawn from true lumen <NUM> of artery <NUM>. With reference to <FIG>, it will be appreciated that guidewire <NUM> remains in the position formerly occupied by crossing device <NUM>.

The position of guidewire <NUM> shown in <FIG> may be achieved using crossing device <NUM>. Guidewire <NUM> may be positioned, for example, by first placing crossing device <NUM> in the position shown in the previous figure, then advancing guidewire <NUM> through lumen <NUM> defined by shaft <NUM> of crossing device <NUM>. Alternately, guidewire <NUM> may be disposed within lumen <NUM> while crossing device <NUM> is advanced beyond occlusion <NUM>.

With guidewire <NUM> in the position shown in <FIG>, guidewire <NUM> may be used to direct other devices between occlusion <NUM> and adventitia <NUM>. For example, a catheter may be advanced over guidewire <NUM> until the distal end of the catheter extends between an occlusion and the adventia. After reaching this location, the catheter may be used to dilate the tissue surrounding the catheter. Examples of catheters that may be used to dilate tissue include balloon catheters and atherectomy catheters.

<FIG> is an additional view of artery <NUM> and guidewire <NUM> shown in the previous figure. In the embodiment of <FIG>, an orienting device <NUM> has been advanced over guidewire <NUM>. Orienting device <NUM> includes a shaft <NUM> comprising a wall <NUM> defining a lumen <NUM>. A first aperture <NUM> and a second aperture <NUM> are also defined by wall <NUM>. In the embodiment of <FIG>, first aperture <NUM> and second aperture <NUM> are both in fluid communication with lumen <NUM>.

In the embodiment of <FIG>, orienting device <NUM> has been positioned so that first aperture <NUM> opens toward intima <NUM> of artery <NUM> and second aperture <NUM> opens toward adventitia <NUM>. With reference to <FIG>, it will be appreciated that first aperture extends in a first direction that is represented by a first arrow AA and second aperture extends in a second direction that is represented by a second arrow AB.

In <FIG>, first arrow AA and second arrow AB are used to illustrate the fact that the second direction is general opposite the first direction. In the embodiment of <FIG>, first arrow AA and second arrow AB are orient <NUM> degrees away from each other. In the embodiment of <FIG>, first aperture <NUM> and second aperture <NUM> are longitudinally separated from one another. Orienting device <NUM> includes a radiopaque marker <NUM> that is located between first aperture <NUM> and second aperture <NUM>.

<FIG> is an additional view of artery <NUM> and orienting device <NUM> shown in the previous figure. In the embodiment of <FIG>, guidewire <NUM> has been withdrawn leaving orienting device <NUM> in the position shown in <FIG>. With reference to <FIG>, it will be appreciated that orienting device <NUM> extends beyond occlusion <NUM>. In <FIG>, occlusion <NUM> is shown blocking true lumen <NUM>. Occlusion <NUM> divides true lumen <NUM> into a proximal segment <NUM> and a distal segment <NUM>. When an orienting device in accordance with some embodiments disclosed herein is advanced between the adventitia and the intima of an artery, the orienting device may be used to direct a re-entry device toward true lumen <NUM>. Fluid communication between proximal segment <NUM> and distal segment <NUM> may be achieved by re-entering the true lumen with the re-entry device.

<FIG> is an additional view of artery <NUM> and orienting device <NUM> shown in the previous figure. In the embodiment of <FIG>, a re-entry device <NUM> has been advanced into lumen <NUM> of orienting device <NUM>. Some useful methods include the step of advancing the distal end of re-entry device <NUM> into true lumen <NUM>.

<FIG> is an enlarged partial cross-sectional view showing a portion of re-entry device <NUM> and orienting device <NUM> shown in the previous figure. With reference to <FIG>, it will be appreciated that re-entry device <NUM> includes a bend <NUM> near distal end <NUM> of re-entry device <NUM>.

<FIG> is an additional partial cross-sectional view showing a portion of re-entry device <NUM> and orienting device <NUM>. <FIG> is further enlarged and simplified relative to the items shown in the previous figure. In the embodiment of <FIG>, a body <NUM> of re-entry device <NUM> is biased to assume a bent shape including a bend <NUM>. Also in the embodiment of <FIG>, shaft <NUM> of orienting device <NUM> is holding re-entry device <NUM> in a somewhat compressed state. When this is the case, re-entry device <NUM> can be inserted through first aperture <NUM> by positioning distal end <NUM> over first aperture <NUM> and allowing bend <NUM> to assume it's natural state (i.e., bent at a sharper angle). Re-entry device <NUM> can be inserted through aperture <NUM> until it comes into contact with intima <NUM>.

It the embodiment of <FIG>, distal end <NUM> of core <NUM> is axially aligned with first aperture <NUM>, however, bend <NUM> is causing distal end <NUM> to point away from first aperture <NUM>. When this is the case, distal end <NUM> may be positioned over first aperture <NUM> by rotating core <NUM>.

<FIG> is an enlarged partial cross-sectional view showing a portion of re-entry device <NUM> and orienting device <NUM> shown in the previous figure. In the embodiment of <FIG>, re-entry device <NUM> has been positioned so that a distal portion of re-entry device <NUM> has entered first aperture <NUM>. Intima <NUM> is shown below first aperture <NUM> in <FIG>.

<FIG> is an enlarged partial cross-sectional view showing a portion of re-entry device <NUM> and intima <NUM>. With reference to <FIG>, it will be appreciated that re-entry device <NUM> comprises a body <NUM> and a core <NUM>. In the embodiment of <FIG>, core <NUM> has been advanced so that a portion of core <NUM> extends beyond body <NUM>. For purposes of illustration and exposition, the portion of core <NUM> extending beyond body <NUM> is referred to as a penetrator <NUM>. Embodiments of re-entry device <NUM> are contemplated in which penetrator <NUM> is fixed in the position shown in <FIG>.

<FIG> is an enlarged partial cross-sectional view showing a portion of re-entry device <NUM>. In the embodiment of <FIG>, re-entry device <NUM> has been advanced so that penetrator <NUM> is shown contacting intima <NUM> in <FIG>.

<FIG> is an enlarged partial cross-sectional view showing a portion of re-entry device <NUM>. In the embodiment of <FIG>, penetrator <NUM> of re-entry device <NUM> has pierced intima <NUM>.

<FIG> is an enlarged partial cross-sectional view showing a portion of re-entry device <NUM>. In the embodiment of <FIG>, re-entry device <NUM> has been advanced so that distal end <NUM> of re-entry device <NUM> is disposed in true lumen <NUM>.

<FIG> is a partial cross-sectional view of re-entry device <NUM> shown in the previous figure. <FIG> has a different scale than the previous figure so that more of the surrounding context is visible in <FIG>. In <FIG>, distal end <NUM> of re-entry device <NUM> can be seen residing in true lumen <NUM>.

<FIG> is an additional view of artery <NUM> shown in the previous figure. In the embodiment of <FIG>, orienting device <NUM> has been withdrawn leaving re-entry device <NUM> in the position shown in <FIG>. Devices such as balloon angioplasty catheters and atherectomy catheters may be advanced over re-entry device <NUM>. In this way, these devices may be used in conjunction with re-entry device <NUM> to establish a blood flow path between proximal segment <NUM> of true lumen <NUM> and distal segment <NUM> of true lumen <NUM>. This path allows blood to flow around occlusion <NUM>.

<FIG> is a plan view of a re-entry device <NUM> in accordance with the present description. Crossing device <NUM> includes an elongate body <NUM> having a distal end <NUM> and a proximal end <NUM>. In the embodiment of <FIG>, a core <NUM> extends into a lumen <NUM> defined by body <NUM>. In some useful embodiments, core <NUM> is free to advance and retract relative to body <NUM>. When core <NUM> is moved relative to body <NUM>, penetrator <NUM> can be caused to selectively assume the retracted position and/or the deployed position. In <FIG>, penetrator <NUM> is shown in the deployed position.

In the embodiment of <FIG>, an actuating fixture <NUM> is fixed to body <NUM> near proximal end <NUM>. Also in <FIG>, a pushing force is shown acting on a proximal portion of core <NUM>. This pushing force is represented by an arrow PF in <FIG>. Actuating fixture <NUM> may be used when creating relative motion between core <NUM> and body <NUM>. Actuating fixture <NUM> may be held to hold body <NUM> relatively stationary and pushing/pulling forces may be applied to core <NUM> to move core <NUM> relative to body <NUM>. In <FIG>, body <NUM> of re-entry device <NUM> is shown being bent at an angle A. Accordingly, it can be said that re-entry device <NUM> includes a bend <NUM>. In some useful embodiments of re-entry device <NUM>, angle A is between about <NUM> degrees and about <NUM> degrees.

<FIG> is an additional plan view of re-entry device <NUM> shown in the previous figure. In the embodiment of <FIG>, penetrator <NUM> is assuming a retracted position. A pulling force applied to core <NUM> while holding actuating fixture <NUM> relatively stationary may cause penetrator <NUM> to assume the retracted position.

With reference to the figures, it will be appreciated that when penetrator <NUM> is in the retracted position, the distal portion of re-entry device <NUM> has a less traumatic shape than when penetrator <NUM> is in the deployed position. Conversely, when penetrator <NUM> is in the deployed position, the distal portion of re-entry device <NUM> has a more traumatic shape than when penetrator <NUM> is in the retracted position.

The position of core <NUM> may be changed relative to body <NUM> by apply pushing and/or pulling forces on core <NUM> and body <NUM>. In <FIG>, a pulling force is represented with an arrow UF. A physician may utilize this mechanism to selectively alter the overall shape of a distal portion of re-entry device <NUM>. Changes in the shape of the distal portion of re-entry device <NUM> may assist in re-entry through the intima.

<FIG> is a plan view of a re-entry device <NUM> illustrating selected dimensions of re-entry device <NUM>. In the embodiment of <FIG>, a penetrator <NUM> of core <NUM> extends beyond a distal end <NUM> of body <NUM> by a distance L1. In the embodiment of <FIG>, penetrator <NUM> has a diameter D1 and body <NUM> has a diameter D2. With reference to <FIG>, it will be appreciated that diameter D2 of body <NUM> is greater than diameter D1 of penetrator <NUM>.

With reference to <FIG>, it will be appreciated that body <NUM> of re-entry device <NUM> includes a bend <NUM> near its distal end <NUM>. Body <NUM> has a distal leg <NUM> disposed distally of bend <NUM> and a proximal leg <NUM> disposed proximally of bend <NUM>. As shown in <FIG>, distal leg <NUM> has a length of L2. With reference to <FIG>, it will be appreciated that length L2 is greater than distance L1.

In some useful embodiments, diameter D1 of penetrator <NUM> is between about <NUM> (<NUM> inches) and about <NUM> (<NUM> inches).

In some useful embodiments, diameter D2 of body <NUM> is between about <NUM> (<NUM> inches) and about <NUM> (<NUM> inches).

In some useful embodiments, length L1 of penetrator <NUM> is between about <NUM> (<NUM> inches) and about <NUM> (<NUM> inches).

In some useful embodiments, length L2 of distal leg <NUM> is between about <NUM> (<NUM> inches) and about <NUM> (<NUM> inches).

<FIG> and <FIG> illustrate a method in which re-entry device <NUM> has been advanced while core <NUM> is in a retracted position. With reference to the figures, it will be appreciated that re-entry device <NUM> has not penetrated intima <NUM>. Instead, re-entry device has been advanced between intima <NUM> and the exterior of orienting device <NUM>.

<FIG> is a cross-sectional view of an orienting device <NUM>. Orienting device <NUM> includes a shaft <NUM> comprising a wall <NUM> defining a lumen <NUM>. Wall <NUM> defines a first aperture <NUM> and a second aperture <NUM> that are both in fluid communication with lumen <NUM>. In the embodiment of <FIG>, first aperture <NUM> extends away from lumen <NUM> in a first direction that is represented by a first arrow AA in <FIG>. Second aperture <NUM> extends away from lumen <NUM> in a second direction that is represented by a second arrow AB in <FIG>. In <FIG>, first arrow AA and second arrow AB extend in generally opposite directions. Accordingly, the first direction is about <NUM> degrees from the second direction.

In the embodiment of <FIG>, first aperture <NUM> and second aperture <NUM> are longitudinally separated from one another. Orienting device <NUM> includes a first radiopaque marker 130A that is located between first aperture <NUM> and second aperture <NUM>. A second radiopaque marker 130B of orienting device <NUM> is located distally of second aperture <NUM>.

A re-entry device <NUM> is disposed in lumen <NUM> of orienting device <NUM>. In the embodiment of <FIG>, first radiopaque marker 130A, second radiopaque marker 130B and re-entry device <NUM> comprise radiopaque materials. Because of the radiopaque nature of their materials of construction, first radiopaque marker 130A, second radiopaque marker 130B, and re-entry device <NUM> will all be visible on a fluoroscopic display during a fluoroscopic procedure.

<FIG> is a representation of a fluoroscopic display <NUM>. First radiopaque marker 130A, second radiopaque marker 130B, and re-entry device <NUM> are visible in fluoroscopic display <NUM>. In the embodiment of <FIG>, distal end <NUM> of re-entry device <NUM> is located slightly proximal of first radiopaque marker 130A. Accordingly, re-entry device <NUM> is seen extending across fluoroscopic display <NUM> and ending just short of first radiopaque marker 130A. When a physician views display <NUM> shown in <FIG>, the physician may infer that distal end <NUM> is proximate first aperture <NUM> of orienting device <NUM>. After determining that distal end <NUM> of re-entry device <NUM> is in this location, the physician can rotate re-entry device <NUM> until distal end <NUM> enters into first aperture <NUM>.

<FIG> is a plan view including orienting device <NUM> shown in the previous figure. In <FIG>, a distal portion of re-entry device <NUM> can be seen extending through first aperture <NUM>. First aperture <NUM> and second aperture <NUM> both fluidly communicate with lumen <NUM> of orienting device <NUM>. Orienting device <NUM> includes a first radiopaque marker 130A that is located between first aperture <NUM> and second aperture <NUM>. A second radiopaque marker 130B of orienting device <NUM> is located distally of second aperture <NUM>.

Orienting device <NUM> comprises an elongate shaft <NUM>, a first orienting element <NUM>, and second orienting element (not visible in <FIG>). First orienting element <NUM> comprises a first balloon <NUM> and second orienting element comprises a second balloon. When these balloons are inflated between the adventitia and the intima of a blood vessel, orienting device <NUM> will orient itself within the blood vessel so that either first aperture <NUM> or second aperture <NUM> will open toward a true lumen of the artery. The physician may select the aperture opening toward the true lumen using methods described herein. The physician may then use methods in accordance with this disclosure to insert distal end <NUM> of re-entry device <NUM> through the selected aperture.

<FIG> is a cross-sectional view of an orienting device <NUM>. Orienting device <NUM> includes a shaft <NUM> comprising a wall <NUM> defining a lumen <NUM>. In the embodiment of <FIG>, a re-entry device <NUM> is disposed in lumen <NUM>. Wall <NUM> defines a first aperture <NUM> and a second aperture <NUM> that are both in fluid communication with lumen <NUM>.

In the embodiment of <FIG>, first aperture <NUM> and second aperture <NUM> are longitudinally separated from one another. Orienting device <NUM> includes a first radiopaque marker 130A that is located between first aperture <NUM> and second aperture <NUM>. Orienting device <NUM> also comprises a second radiopaque marker 130B that is located distally of second aperture <NUM>. With reference to <FIG>, it will be appreciated that first radiopaque marker 130A and second radiopaque maker 130B are both surrounded by wall <NUM> of shaft <NUM>.

In the embodiment of <FIG>, first radiopaque marker 130A, second radiopaque marker 130B and re-entry device <NUM> comprise radiopaque materials. Because of the radiopaque nature of their materials of construction, first radiopaque marker 130A, second radiopaque marker 130B, and re-entry device <NUM> will all be visible on a fluoroscopic display during a fluoroscopic procedure.

<FIG> is a representation of a fluoroscopic display <NUM>. First radiopaque marker 130A, second radiopaque marker 130B, and re-entry device <NUM> are visible in fluoroscopic display <NUM>. In the embodiment of <FIG>, distal end <NUM> of re-entry device <NUM> is located slightly proximal of second radiopaque marker 130B. Accordingly, re-entry device <NUM> is seen extending across fluoroscopic display <NUM> and ending just short of second radiopaque marker 130B. When a physician views display <NUM> shown in <FIG>, the physician may infer that distal end <NUM> is proximate second aperture <NUM> of orienting device <NUM>. After determining that distal end <NUM> of re-entry device <NUM> is in this location, the physician can rotate re-entry device <NUM> until distal end <NUM> enters into second aperture <NUM>.

<FIG> is a plan view including orienting device <NUM> shown in the previous figure. Orienting device <NUM> comprises an elongate shaft <NUM>, a first balloon <NUM>, and a second balloon <NUM>. In the embodiment of <FIG>, first balloon <NUM> and second balloon <NUM> are both formed from extruded portions of an outer wall <NUM> of elongate shaft <NUM>. Outer wall <NUM> defines a second aperture <NUM>. In <FIG>, a re-entry device <NUM> is shown extending through second aperture <NUM>.

<FIG> is a cross sectional view of orienting device <NUM> taken along line A-A shown in <FIG>. With reference to <FIG>, it will be appreciated that elongate shaft <NUM> defines a lumen 122A, a first planetary lumen 122B, and a second planetary lumen 122C. The planetary lumens are defined in part by an outer wall <NUM> of elongate shaft <NUM>. Outer wall <NUM> defines a first aperture <NUM> and a second aperture <NUM>.

In the embodiment of <FIG>, a first balloon <NUM> is formed of an extruded portion of outer wall <NUM> of elongate shaft <NUM>. First balloon <NUM> defines an interior that is in fluid communication with first planetary lumen 122B. In the embodiment of <FIG>, first balloon <NUM> and elongate shaft <NUM> are monolithic. As shown in <FIG>, first balloon <NUM> and outer wall <NUM> of elongate shaft <NUM> are seamlessly formed from a single piece of material. With reference to <FIG>, it will be appreciated that second balloon <NUM> defines an interior that is in fluid communication with second planetary lumen 122C. In the embodiment of <FIG>, second balloon <NUM> comprises an extruded portion of outer wall <NUM> of elongate shaft <NUM>.

As shown in <FIG>, second balloon <NUM> and elongate shaft <NUM> are seamlessly formed from a single piece of material. Second balloon <NUM> may be formed, for example, by extruding a portion of outer wall <NUM>. In some useful embodiments, elongate shaft <NUM> comprises a thermoplastic material. When this is the case, elongate shaft <NUM> may be formed, for example, using an extrusion process. Also when this is the case, first balloon <NUM> and second balloon <NUM> may be formed by further extruding outer wall <NUM> of elongate shaft <NUM>.

<FIG> is a cross-sectional view of an artery <NUM> having a wall <NUM>. In <FIG>, wall <NUM> of artery <NUM> is shown having three layers. The outermost layer of wall <NUM> is the adventitia <NUM> and the innermost layer of wall <NUM> is the intima <NUM>. The tissues extending between intima <NUM> and adventitia <NUM> may be collectively referred to as the media <NUM>. For purposes of illustration, intima <NUM>, media <NUM> and adventitia <NUM> are each shown as a single homogenous layer in <FIG>. In the human body, however, the intima and the media each comprise a number of sublayers. The transition between the extemal most portion of the intima and the internal most portion of the media is sometimes referred to as the subintimal space. Intima <NUM> defines a true lumen <NUM> of artery <NUM>.

In <FIG>, orienting device <NUM> is shown disposed between adventitia <NUM> and intima <NUM> of artery <NUM>. Orienting device <NUM> may be used to direct a re-entry device <NUM> toward true lumen <NUM> of artery <NUM> as shown in <FIG>. The first aperture <NUM> and second aperture <NUM> are generally oriented at a right angle to a plane defined by first balloon <NUM> and second balloon <NUM>. With this arrangement, each aperture is either directed toward true lumen <NUM> of artery <NUM> or <NUM> degrees away from true lumen <NUM> when first balloon <NUM> and second balloon <NUM> are inflated. In this way, orienting device <NUM> reduces the number of directions an aperture may be facing from <NUM> degrees of freedom to two degrees of freedom, <NUM> degrees apart.

<FIG> is a partial cross-sectional view of an exemplary crossing device <NUM>. Crossing device <NUM> of <FIG> comprises a tip <NUM> that is fixed to a distal end of a shaft <NUM>. In the exemplary embodiment of <FIG>, shaft <NUM> comprises a coil <NUM>, a sleeve <NUM>, a tubular body <NUM>, and a sheath <NUM>.

Tip <NUM> is fixed to a distal portion of coil <NUM>. Coil <NUM> comprises a plurality of filars that are wound in a generally helical shape. In some useful embodiments of crossing device <NUM>, coil <NUM> comprises eight, nine or ten filars wound into the shape illustrated in <FIG>. Crossing device <NUM> includes a sleeve <NUM> that is disposed about a portion of coil <NUM>. Sleeve <NUM> may comprise, for example, PET shrink tubing, i.e. polyethylene terephthalate.

Sleeve <NUM> and coil <NUM> both extend into a lumen defined by a tubular body <NUM>. Tubular body <NUM> may comprise, for example hypodermic tubing formed of Nitnol, i.e. nickel titanium. With reference to <FIG>, it will be appreciated that a proximal portion of sleeve <NUM> is disposed between tubular body <NUM> and coil <NUM>. In some embodiments of crossing device <NUM>, a distal portion of tubular body <NUM> defines a helical cut. This helical cut may be formed, for example, using a laser cutting process. The helical cut may be shaped and dimensioned to provide an advantageous transition in lateral stiffness proximate the distal end of tubular body <NUM>.

A proximal portion of coil <NUM> extends proximally beyond the distal end of tubular body <NUM>. A hub is fixed to a proximal portion of coil <NUM> and a proximal portion of tubular body <NUM>. The hub may comprise, for example, a luer fitting. A sheath <NUM> is disposed about a portion of tubular body <NUM> and a portion of sleeve <NUM>. In some embodiments of crossing device <NUM>, sheath <NUM> comprises HYTREL, a thermoplastic elastomer.

With reference to <FIG>, it will be appreciated that tubular body <NUM>, coil <NUM>, sleeve <NUM>, and sheath <NUM> each have a proximal end and a distal end. The proximal end of outer sleeve <NUM> is disposed between the proximal end of tubular body <NUM> and the proximal end of sleeve <NUM>. The distal end of sleeve <NUM> is positioned proximate tip <NUM> that is fixed to the distal end of coil <NUM>. The distal end of sheath <NUM> is located between the distal end of tubular body <NUM> and the distal end of sleeve <NUM>. With reference to <FIG>, it will be appreciated that sheath <NUM> overlays the distal end of tubular body <NUM>.

With reference to <FIG>, it will be appreciate that tip <NUM> has a generally rounded shape. The generally rounded shape of tip <NUM> may reduce the likelihood that crossing device <NUM> will penetrate the adventitia of an artery. Tip <NUM> may be formed from a suitable metallic material including but not limited to stainless steel, silver solder, and braze. Tip <NUM> may also be formed from suitable polymeric materials or adhesives including but not limited to polycarbonate, polyethylene and epoxy. In some embodiments of crossing device <NUM>, the outer surface of tip <NUM> comprises a generally non-abrasive surface. For example, the outer surface of tip <NUM> may have a surface roughness of about <NUM> micrometers or less. A tip member having a relatively smooth outer surface may reduce the likelihood that the tip member will abrade the adventitia of an artery.

<FIG> is a plan view showing an assembly <NUM> including crossing device <NUM> shown in the previous figure. In the embodiment of <FIG>, a drive assembly <NUM> is coupled to crossing device <NUM>. In <FIG>, drive assembly <NUM> is shown disposed about a proximal portion of shaft <NUM> of crossing device <NUM>. Drive assembly <NUM> comprises a handle body <NUM> and an anchor <NUM>.

As shown in <FIG>, handle body <NUM> of drive assembly <NUM> is long enough to receive the thumb and forefingers of a right hand RH and a left hand LH. Anchor <NUM> of drive assembly <NUM> defines a hole <NUM>. With reference to <FIG>, it will be appreciated that a finger F of right hand RH is extending through hole <NUM> in anchor <NUM>. Left hand LH and right hand RH may rotate handle body <NUM> of drive assembly <NUM>. When this is the case, finger F extending through anchor <NUM> prevents anchor <NUM> from rotating while handle body <NUM> rotates.

In <FIG>, a distal portion of handle body <NUM> is positioned between the thumb and forefinger of a left hand LH. A proximal portion of handle body <NUM> is disposed between the thumb and forefinger of a right hand RH. In some useful methods, crossing device <NUM> is rotated and axially advanced simultaneously. Rotation of crossing device <NUM> can be achieved by rolling handle body <NUM> between the thumb and forefinger one hand. Two hands can also be used as shown in <FIG>. Rotating crossing device <NUM> assures that the coefficient of friction at the interface between the crossing device and the surrounding tissue will be a kinetic coefficient of friction and not a static coefficient of friction.

<FIG> is a cross-sectional view of assembly <NUM> shown in the previous figure. Assembly <NUM> includes a drive assembly <NUM> and a crossing device <NUM>. With reference to <FIG>, it will be appreciated that drive assembly <NUM> includes a central gear <NUM> that is fixed to shaft <NUM> of crossing device <NUM>. Drive assembly <NUM> also includes a handle body <NUM>. An internal gear <NUM> is fixed to handle body <NUM>.

A plurality of planetary gears <NUM> are disposed between central gear <NUM>. A ring <NUM> maintains the spacing between adjacent pairs planetary gears <NUM>. Anchor <NUM> is fixed to ring <NUM>. Anchor <NUM> defines a hole <NUM>. Central gear <NUM>, planetary gears <NUM>, and internal gear <NUM> together form a gear train providing a mechanical advantage. Due to this mechanical advantage, a single rotation of handle body <NUM> results in many rotations of shaft <NUM> of crossing device <NUM>.

In some useful methods in accordance with the present disclosure, crossing device <NUM> is rotated at a rotational speed of between about <NUM> revolutions per minute and about <NUM> revolutions per minute. In some particularly useful methods in accordance with the present disclosure, crossing device <NUM> is rotated at a rotational speed of between about <NUM> revolutions per minute and about <NUM> revolutions per minute. Crossing device <NUM> may be rotated by hand as depicted in the previous figure. It is also contemplated that a mechanical device (e.g., an electric motor) may be used to rotate crossing device <NUM>.

Claim 1:
An apparatus for facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the apparatus comprising:
an intravascular device (<NUM>) having a lumen (<NUM>) and a distal portion, the distal portion including at least one aperture (<NUM>, <NUM>), at least one radiopaque marker (<NUM>), and at least one orienting element (<NUM>); and
a reentry device (<NUM>) having a body (<NUM>) with a proximal portion and a distal portion, and a penetrator (<NUM>) extending distally beyond a distal end (<NUM>) of the body (<NUM>) in a deployed position, wherein a diameter of the body (<NUM>) is greater than a diameter of the penetrator (<NUM>), wherein the reentry device (<NUM>) has a natural state and a compressed state, wherein when the reentry device (<NUM>) is in the compressed state, the distal portion is substantially aligned with the proximal portion, whereby the reentry device (<NUM>) is configured to be advanced into the lumen (<NUM>) of the intravascular device (<NUM>), and wherein when the reentry device (<NUM>) is in the natural state, the distal portion forms an angle with respect to the proximal portion, whereby the distal portion of the reentry device (<NUM>) is configured to be advanced through the at least one aperture (<NUM>, <NUM>);
wherein the penetrator is fixed in the deployed position;
and
wherein the at least one aperture (<NUM>, <NUM>) comprises a first aperture (<NUM>) and a second aperture (<NUM>) that are longitudinally offset from one another and both in fluid communication with the lumen (<NUM>); and
wherein the first aperture (<NUM>) extends away from the lumen (<NUM>) in a first direction and the second aperture (<NUM>) extends away from the lumen (<NUM>) in a second direction, wherein the first direction is about <NUM> degrees from the second direction.