Apparatus and method for crossing a position along a tubular body structure
First Claim
1. An assembly for use with a tubular body structure of the type having a wall with layers, comprising:
- an elongate member delivery assembly comprising;
an elongate body having proximal and distal ends and defining an axis; and
a laterally-extending, layer-separation guide at the distal end, the guide sized and shaped to guide the distal end of the delivery assembly between layers of a wall of a tubular body structure;
a flexible elongate member comprising a proximal portion and a distal portion passable along the elongate body, the distal portion comprising a tip; and
the assembly further comprising a elongate member-redirecting surface positioned and oriented to cause the distal portion of a distally moving elongate member to be redirected to move in a direction at an angle to the axis;
whereby the distal portion may be directed by the assembly into a wall of the tubular body structure, along the tubular body structure between layers of the wall of the tubular body structure, past a position in the tubular body structure, and back through at least one of the layers to enter the tubular body structure distally of the position.
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0 Petitions
Accused Products
Abstract
A vascular occlusion-crossing assembly (2) includes an elongate delivery system (4) and a flexible elongate member (6) which passes along the body (34) of the delivery assembly. A laterally-extending, vascular tunica-separation guide (32) helps guide the distal end (36) of the delivery assembly between tunica layers (40, 42, 44) to a position distal of an occlusion (52). The distal portion (30) of a distally moving elongate member, typically a flexible hollow needle, is deflected into this distal lumen (54) on the far side of an occlusion (52). A guidewire (62) may be passed along the elongate member thereby crossing the occlusion.
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Citations
68 Claims
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1. An assembly for use with a tubular body structure of the type having a wall with layers, comprising:
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an elongate member delivery assembly comprising;
an elongate body having proximal and distal ends and defining an axis; and
a laterally-extending, layer-separation guide at the distal end, the guide sized and shaped to guide the distal end of the delivery assembly between layers of a wall of a tubular body structure;
a flexible elongate member comprising a proximal portion and a distal portion passable along the elongate body, the distal portion comprising a tip; and
the assembly further comprising a elongate member-redirecting surface positioned and oriented to cause the distal portion of a distally moving elongate member to be redirected to move in a direction at an angle to the axis;
whereby the distal portion may be directed by the assembly into a wall of the tubular body structure, along the tubular body structure between layers of the wall of the tubular body structure, past a position in the tubular body structure, and back through at least one of the layers to enter the tubular body structure distally of the position. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
the proximal end adapter comprises a front handle to which a rear handle is movably mounted, the front and rear handles defining a through hole through which the elongate member passes;
a chosen one of the front and rear handles comprising a stop surface engagable by the elongate member stop element; and
the effective length of the through hole being adjustable by a user adjusting the position of at least one of the front and rear handles relative to the other.
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22. The assembly according to claim 21 wherein the rear handle is threadably mounted to the front handle.
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23. The assembly according to claim 20 wherein the proximal end adapter comprises a user-positionable stop surface engagable by a user so to permit a user to limit the distal movement of the elongate member.
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24. The assembly according to claim 1 wherein the layer-separation guide is movable between a laterally-retracted state and a laterally-extended state to permit the assembly to be used percutaneously.
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25. The assembly according to claim 24 wherein the layer-separation guide is biased towards said laterally-extended state.
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26. The assembly according to claim 25 further comprising means for moving the layer-separation guide from the laterally-extended state to the laterally-retracted state.
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27. The assembly according to claim 1 wherein the elongate member comprises a hollow needle and said tip comprises a sharpened tip.
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28. An assembly for use with a tubular body structure of the type having a wall with layers, comprising:
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an elongate member delivery assembly comprising;
an elongate body having proximal and distal ends and defining an axis; and
a laterally-extending, layer-separation guide at the distal end, the guide sized and shaped to guide the distal end of the delivery assembly between layers of a wall of a tubular body structure;
a flexible elongate member comprising a proximal portion and a distal portion passable along the elongate body, the distal portion comprising a tip;
the assembly further comprising a elongate member-redirecting surface positioned and oriented to cause the distal portion of a distally moving elongate member to be redirected to move in a direction at an angle to the axis;
the elongate body comprising a hollow outer sheath, from which the guide extends, and an elongate member support element housed within the outer sheath and at least partly defining an elongate member pathway, said elongate member support element comprising said elongate member-redirecting surface; and
whereby the distal portion may be directed by the assembly into a wall of the tubular body structure, along the tubular body structure between layers of the wall of the tubular body structure, past a position in the tubular body structure, and back through at least one of the layers to enter the tubular body structure distally of the position. - View Dependent Claims (29, 30, 31, 32, 33)
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34. An assembly for use with a tubular body structure of the type having a wall with layers, comprising:
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an elongate member delivery assembly comprising;
an elongate body having proximal and distal ends and defining an axis; and
a laterally-extending, layer-separation guide at the distal end, the guide sized and shaped to guide the distal end of the delivery assembly between layers of a wall of a tubular body structure; and
a flexible elongate tube comprising a proximal portion and a distal portion passable along the elongate body, the distal portion comprising a tip, the proximal portion comprising an injectable-material entrance port;
whereby the distal portion may be directed by the assembly into a wall of the tubular body structure, along the tubular body structure between layers of the wall of the tubular body structure, past a position in the tubular body structure, and back through at least one of the layers to enter the tubular body structure distally of the position, whereby a remotely sensable material may be injected through the tube and into blood vessel to permit remote confirmation of proper placement of the tube. - View Dependent Claims (35, 36)
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37. A vascular occlusion-crossing assembly comprising:
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an elongate member delivery assembly comprising;
an elongate body having proximal and distal ends and defining an axis;
a proximal end adapter at the proximal end;
a laterally-extending, vascular tunica-separation guide at the distal end, the guide sized and shaped to guide the distal end of the delivery assembly between tunicae of a blood vessel;
a flexible elongate member comprising;
a hollow needle comprising proximal and distal portions;
an injectable-fluid entrance-port at the proximal portion; and
the tip portion passable along the elongate body, the tip portion comprising a tip;
the assembly further comprising a elongate member-redirecting surface positioned and oriented to cause the tip portion of a distally moving elongate member to be redirected to move in a direction at an angle to the axis;
a guidewire directable through the hollow needle;
the proximal end adapter comprising means for selecting the maximum movement of the elongate member through the lumen of the elongate body in a distal direction;
whereby the distal portion may be directed by the assembly into a blood vessel wall, along blood vessel between tunicae of the blood vessel, past an obstruction in the blood vessel and back through at least one of the blood vessel tunicae to enter the blood vessel distally of the obstruction, after which a remotely sensable material may be injected through the hollow needle and into the blood vessel to permit remote confirmation of proper placement of the hollow needle, after which the guidewire may be placeable through the hollow needle, and after which one or both of the delivery assembly and elongate member may be removed leaving the guidewire in place. - View Dependent Claims (38, 39, 40)
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41. A vascular occlusion-crossing assembly of the type comprising a flexible elongate member, having a tip portion, and an elongate member delivery system comprising an elongate body, along which the elongate member passes, and a redirecting surface positioned and oriented to cause the distal portion of a distally moving elongate member to be redirected to move in a direction at an angle to the axis, whereby the tip portion may be directed by the assembly into a blood vessel wall, along the blood vessel between tunicae of the blood vessel, past an obstruction in the blood vessel and back through at least one of the blood vessel tunicae to enter the blood vessel distally of the obstruction, the improvement comprising:
a laterally-extending, partially circumferentially-extending, vascular tunica-separation guide at the distal end, the guide sized and shaped to guide the distal end of the delivery assembly between tunicae of a blood vessel.
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42. A vascular occlusion-crossing assembly the type comprising a flexible elongate member, having a tip portion, and an elongate member delivery system comprising an elongate body, along which the elongate member passes, and a redirecting surface positioned and oriented to cause the distal portion of a distally moving elongate member to be redirected to move in a direction at an angle to the axis, whereby the tip portion may be directed by the assembly into a blood vessel wall, along the blood vessel between tunicae of the blood vessel, past an obstruction in the blood vessel and back through at least one of the blood vessel tunicae to enter the blood vessel distally of the obstruction, the improvement comprising:
the elongate member comprising a tube with a flowable material entrance port at a proximal end thereof, so that a remotely sensable material may be injected through the tube and into the blood vessel to permit remote confirmation of proper placement of the tube. - View Dependent Claims (43)
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44. A method for crossing a position along a tubular body structure comprising:
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selecting a position-crossing assembly comprising;
a flexible elongate member;
an elongate member delivery assembly comprising an elongate body, having proximal and distal ends and defining an axis, a laterally-extending separation guide at the distal end, the guide sized and shaped to guide the distal end of the delivery assembly between layers of a wall of a tubular body structure, and an elongate member-redirecting surface positioned and oriented to cause the distal portion of a distally moving elongate member to be redirected to move in a direction at an angle to the axis;
positioning the laterally-extending separation guide between wall layers of a tubular body structure;
passing the guide between the wall layers from a location proximal of a position along the tubular body structure to location distal of the position; and
thendriving the elongate member along the axis distal direction against the deflecting surface thereby deflecting the tip portion causing the distal portion to pass through at least one wall layer and into the interior of the tubular body structure. - View Dependent Claims (45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63)
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64. A method for crossing a position along a tubular body structure comprising:
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selecting a position-crossing assembly comprising;
a flexible elongate tube having a tip;
an elongate member delivery assembly comprising an elongate body, having proximal and distal ends and defining an axis, and a laterally-extending separation guide at the distal end, the guide sized and shaped to guide the distal end of the delivery assembly between layers of a wall of a tubular body structure;
positioning the laterally-extending separation guide between wall layers of a tubular body structure;
passing the guide between the wall layers from a location proximal of a position along the tubular body structure to location distal of the position;
driving the elongate member along the axis in a distal direction causing the distal portion to pass through at least one wall layer and into the interior of the tubular body structure; and
injecting a detectable substance through the elongate tube and into the interior of the tubular body structure following the driving step to ensure the tip is properly positioned. - View Dependent Claims (65)
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66. A method for crossing a vascular occlusion comprising:
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selecting a vascular occlusion-crossing assembly comprising;
a flexible elongate member;
an elongate member delivery assembly comprising an elongate body, having proximal and distal ends and defining an axis, a laterally-extending, vascular tunica-separation guide at the distal end, the guide sized and shaped to guide the distal end of the delivery assembly between tunicae of a blood vessel, and an elongate member-redirecting surface positioned and oriented to cause the tip portion of a distally moving elongate member to be redirected to move in a direction at an angle to the axis;
adjusting the maximum distance the elongate member may extend distally past the elongate member-redirecting surface;
positioning the laterally-extending, vascular tunica-separation guide between blood vessel tunicae;
passing the guide between the tunicae from a position proximal of an obstruction within the blood vessel interior to position distal of the obstruction; and
thendriving the elongate member along the axis in a distal direction against the deflecting surface thereby deflecting the distal portion causing the tip portion to pass through at least one blood vessel tunicae and into the blood vessel interior;
injecting a detectable substance through the elongate member and into the blood vessel interior following the driving step to ensure the tip is properly positioned;
passing a guidewire through the elongate member following the injecting step; and
removing the occlusion-crossing assembly leaving the guidewire in place. - View Dependent Claims (67, 68)
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Specification