Aspiration catheters, systems, and methods

Abstract

The aspiration catheters, systems and methods include a catheter having an elongated body with a cross-section having a flat side and a curve near the distal end. The first side of the cross-section can contact a first side of a delivery lumen in a first orientation, and a second side of the cross-section contacts the first side of the delivery lumen in a second orientation rotated 180° from the first orientation. The curve can be directed 90° relative to a normal of the flat side. The systems and methods can utilize two catheters, and a key joint formed with the two catheters which can rotationally fix the catheters with respect to each other, and the first and second catheters each include at least one pre-formed curve near the distal end. The two catheters can be moved proximally and distally for positioning in the right and left bronchi.

1 . A catheter for insertion into a body lumen of a patient, comprising:
 a distal end configured for insertion into the body lumen of the patient;   a proximal end;   an elongated body extending between the proximal and distal ends and having a cross-section that includes, over at least a portion of the elongated body, a first side that is flat and a second side on an opposite side of the cross-section from the first side; and   at least one lumen extending through the elongated body from the proximal end to the distal end,   wherein the elongated body includes at least one pre-formed curve near the distal end,   wherein, when the distal end is adapted for insertion into the body lumen of the patient, the first side of the cross-section contacts a first inner side of a delivery lumen of the catheter when the catheter is in a first orientation, and the second side of the cross-section contacts the first inner side of the delivery lumen of the catheter when the catheter is in a second orientation, the second orientation being a 180° rotation of the catheter about a longitudinal axis of the elongated body relative to the first orientation, and   wherein a curve direction of the at least one pre-formed curve is 90° with respect to a normal direction of the flat side of the cross-section.   
     
     
         2 . The catheter according to  claim 1 , wherein the second side of the cross-section is curved. 
     
     
         3 . The catheter according to  claim 2 , wherein the cross-section is D-shaped. 
     
     
         4 . The catheter according to  claim 1 , further comprising:
 a curve-direction indicator on the proximal end that indicates a curve direction of the at least one pre-formed curve of the distal end of the catheter.   
     
     
         5 . The catheter according to  claim 4 , wherein the curve-direction indicator comprises a connector on the proximal end. 
     
     
         6 . The catheter according to  claim 5 , wherein the connector includes a central connection portion and a side connection portion extending from the central connection portion, wherein a direction in which the side connection portion extends corresponds to the curve direction of the at least one preformed curve. 
     
     
         7 . The catheter according to  claim 1 , wherein the at least one curve and the first side are arranged such that, when the distal end is adapted for insertion into the body lumen of the patient, the at least one curve directs the elongated body toward one of a left bronchus and a right bronchus of the patient in the first orientation, and toward the other of the left bronchus and the right bronchus of the patient in the second orientation. 
     
     
         8 . The catheter according to  claim 7 , wherein the catheter has a torsional stiffness such that, when the distal end is adapted for insertion into the body lumen of the patient, the distal end remains disposed toward one of the left bronchus and the right bronchus within an angle of rotation of the proximal end from 0° to a first predetermined angle, the angle of rotation of the proximal end being relative to one of the first and second orientations, and
 wherein the distal end is disposed toward the other of the left and right bronchus when the proximal end is between the first predetermined angle and a second predetermined angle. 
 
     
     
         9 . The catheter according to  claim 8 , wherein the first predetermined angle is at least 90°, and the second predetermined angle is at least 180°. 
     
     
         10 . The catheter according to  claim 9 , wherein the first predetermined angle is at least 150° and the second predetermined angle is at least 210°. 
     
     
         11 . The catheter according to  claim 9 , wherein the first predetermined angle is about 180° and the second predetermined angle is about 360°. 
     
     
         12 . A catheter for insertion into a body lumen of a patient, comprising:
 a distal end configured for insertion into the body lumen of the patient;   a proximal end;   an elongated body extending between the proximal and distal ends and having a cross-section that includes, over at least a portion of the elongated body, a portion that is substantially flat, the elongated body having a torqueability ratio of 1:1 between the distal and proximal ends; and   at least one lumen extending through the elongated body from the proximal end to the distal end,   wherein the elongated body is adapted to be arranged in a delivery lumen of an outer catheter such that, when the distal end is adapted for insertion into the body lumen of the patient, the distal end is directed toward one of a left bronchus and a right bronchus of the patient, and   wherein the elongated body is configured such that the distal end remains directed toward the one of the left and right bronchi during a rotation of the proximal end about a longitudinal axis of the elongated body until a predetermined angle of rotation of the proximal end is reached, at which point the distal end flips to the other of the left bronchus and the right bronchus.   
     
     
         13 . The catheter according to  claim 12 , wherein the predetermined angle is at least 90°. 
     
     
         14 . The catheter according to  claim 13 , wherein the predetermined angle is about 180°. 
     
     
         15 . The catheter according to  claim 12 , wherein the elongated body includes at least one pre-formed curve near the distal end that directs the distal end toward one of the left bronchus and the right bronchus. 
     
     
         16 . The catheter according to  claim 12 , wherein, when the distal end is adapted for insertion into the body lumen of the patient, the portion that is substantially flat contacts a first inner side of the delivery lumen when the catheter is in a first orientation, and the portion that is substantially flat does not contact the first inner side of the delivery lumen when the catheter is in a second orientation, the distal end being directed toward one of the left bronchus and the right bronchus in the first orientation and toward the other of the left and right bronchi in the second orientation. 
     
     
         17 . The catheter according to  claim 16 , wherein the portion that is substantially flat contacts the first inner side of the delivery lumen at only one point in the first orientation. 
     
     
         18 . The catheter according to  claim 16 , wherein the portion that is substantially flat contacts the first inner side of the delivery lumen at only two points in at least one of the first and the second orientations. 
     
     
         19 . The catheter according to  claim 12 , wherein the catheter is comprised of a copolymer. 
     
     
         20 . The catheter according to  claim 19 , wherein the copolymer is chosen from the Kynar Flex® Copolymer Series. 
     
     
         21 . A catheter for insertion into a body lumen of a patient, comprising:
 a distal end configured for insertion into the body lumen of the patient;   a proximal end;   an elongated body extending between the proximal and distal ends and having a torqueability ratio of 1:1 between the distal and proximal ends; and   at least one lumen extending through the elongated body from the proximal end to the distal end,   wherein the elongated body has a torsional stiffness such that, when the elongated body is adapted for insertion into a delivery lumen of an outer catheter, the distal end remains in one of a first resting orientation and a second resting orientation during a rotation of the proximal end about a longitudinal axis of the catheter.   
     
     
         22 . The catheter according to  claim 21 , wherein the distal end remains in the first resting orientation through greater than 90° of rotation of the proximal end. 
     
     
         23 . The catheter according to  claim 22 , wherein the distal end changes from the first resting orientation to the second resting orientation when the proximal end rotates about 180°. 
     
     
         24 . A method of orienting a catheter in a body lumen of a patient, comprising:
 providing the catheter, the catheter having a distal end configured for insertion into the body lumen of the patient, a proximal end, and an elongated body extending between the proximal and distal ends;   providing an outer catheter adapted to be inserted into a body lumen of a patient and to receive the distal end of the catheter;   inserting the catheter into the body lumen of the patient through the outer catheter;   rotationally orienting the proximal end of the catheter to a first orientation, the distal end of the catheter being directed toward one of a left bronchus and a right bronchus of the patient in the first orientation;   changing a direction of the distal end of the catheter by rotating the proximal end of the catheter to a second orientation, the second orientation being a substantially 180° rotation of the proximal end relative to the first orientation, the distal end being directed toward the other of the left and right bronchi when the proximal end is in the second orientation.   
     
     
         25 . A catheter for insertion into a body lumen of a patient, comprising:
 a distal end configured for insertion into the body lumen of the patient;   a proximal end;   an elongated body extending between the proximal and distal ends and having a cross-section that includes, over at least a portion of the elongated body, a portion that is substantially flat;   at least one lumen extending through the elongated body from the proximal end to the distal end; and   at least one pre-formed curve near the distal end of the elongated body,   wherein the at least one pre-formed curve curves the catheter in a direction that is orthogonal to a normal direction of the flat side of the cross-section.   
     
     
         26 . The catheter according to  claim 25 , wherein the elongated body has a torqueability ratio of 1:1 between the distal and proximal ends. 
     
     
         27 . The catheter according to  claim 25 , wherein the elongated body is configured such that the distal end remains directed toward one of a left bronchus and a right bronchus during a rotation of the proximal end about a longitudinal axis of the elongated body until a predetermined angle of rotation of the proximal end is reached, at which point the distal end flips to the other of the left bronchus and the right bronchus 
     
     
         28 . The catheter according to  claim 25 , wherein the at least one lumen comprises:
 a first lumen with a first opening near the distal end of the catheter, and   a second lumen with a second opening near the distal end of the catheter, the second opening being spaced apart from the first opening such that the first opening is disposed distally to the second opening.   
     
     
         29 . The catheter according to  claim 28 , wherein the second opening is disposed on the at least one pre-formed curve on the inside of the curve of the at least one pre-formed curve. 
     
     
         30 . The catheter according to  claim 25 , wherein an outside curve surface of the at least one preformed curve is a smooth surface that is uninterrupted by any opening to the at least one lumen of the catheter. 
     
     
         31 . The catheter according to  claim 25 , wherein the at least one pre-formed curve comprises a first curve and a second curve, and
 wherein the at least one lumen comprises:
 a first lumen with a first opening disposed on an inside curve of the first curve, and 
 a second lumen with a second opening disposed on an inside curve of the second curve. 
   
     
     
         32 . The catheter according to  claim 31 , wherein the inside curve of the first curve faces a different direction than the inside curve of the second curve. 
     
     
         33 . The catheter according to  claim 26 , wherein the cross-section, over at least another portion of the elongated body, does not have a flat side. 
     
     
         34 . The catheter according to  claim 33 , wherein the at least another portion of the elongated body comprises an opening of at least one of the at least one lumen, the opening being near the distal end of the catheter. 
     
     
         35 . The catheter according to  claim 25 , wherein at least a portion of the elongated body comprises a first key joint component, and wherein the catheter further comprises:
 a second key joint component that is keyed to the first key joint component, the second key joint component being disposed outside of the patient when the distal end of the catheter is adapted for insertion into the body lumen,   wherein the second key joint component is rotationally fixed with response to the catheter.   
     
     
         36 . The catheter according to  claim 25 , further comprising:
 a delivery lumen configured to surround at least a portion of the elongated body when the distal end of the elongated body is adapted for insertion into the body lumen, wherein a portion of the elongated body engages an inner surface of the delivery lumen when the pre-formed curve is curved toward at least one of the left bronchus and the right bronchus.   
     
     
         37 . The catheter according to  claim 36 , wherein the delivery lumen is an endotracheal tube. 
     
     
         38 . The catheter according to  claim 36 , wherein the portion of the elongated body that engages the inner surface of the delivery lumen is the portion of the elongated body that is substantially flat. 
     
     
         39 . The catheter according to  claim 25 , wherein the catheter comprises two catheters, each of the two catheters comprising:
 a distal end configured for insertion into the body lumen of the patient;   a proximal end;   an elongated body extending between the proximal and distal ends and having a cross-section that includes, over at least a portion of the elongated body, a portion that is substantially flat;   at least one lumen extending through the elongated body from the proximal end to the distal end; and   at least one pre-formed curve near the distal end of the elongated body.   
     
     
         40 . The catheter according to  claim 39 , wherein the two catheters are rotationally fixed relative to each other such that the flat side of one of the two catheters faces the flat side of the other of the two catheters. 
     
     
         41 . The catheter according to  claim 39 , wherein each of the two catheters is independently slideable relative to the other of the two catheters. 
     
     
         42 . The catheter according to  claim 39 , wherein the at least one pre-formed curve curves the catheter in a direction that is orthogonal to a normal direction of the flat side of the cross-section. 
     
     
         43 . The catheter according to  claim 39 , wherein the pre-formed curves of the two catheters curve the two catheters in opposite directions. 
     
     
         44 . The catheter according to  claim 43 , wherein an outside curve of the pre-formed curve of one of the two catheters faces an outside curve of the pre-formed curve of the other of the two catheters. 
     
     
         45 . A catheter system comprising:
 a first catheter including:
 a proximal end, 
 a distal end configured for insertion into a body lumen of a patient, 
 an elongated body extending between the proximal and distal ends and having a cross-section that includes, over at least a portion of the elongated body, a first side that is flat and a second side on an opposite side of the cross-section from the first side, and 
 at least one lumen extending through the elongated body from the proximal end to the distal end; 
   a second catheter including:
 a proximal end, 
 a distal end configured for insertion into the body lumen of the patient, 
 an elongated body extending between the proximal and distal ends and having a cross-section that includes, over at least a portion of the elongated body, a first side that is flat and a second side on an opposite side of the cross-section from the first side, and 
 at least one lumen extending through the elongated body from the proximal end to the distal end; 
   a key joint component configured to form a key joint with at least a portion of the elongated bodies near the proximal ends of both the first and second catheters, the portion of the elongated bodies that form the key joint including the first sides that are flat,   wherein the first and second catheters are rotationally fixed with respect to each other via the key joint,   wherein the elongated bodies of the first and second catheters each include at least one pre-formed curve near the distal end.   
     
     
         46 . The catheter system of  claim 45 , wherein at least one of the first and second catheters are slideable relative to the key joint component through the key joint. 
     
     
         47 . The catheter system of  claim 45 , wherein the elongated bodies of the first and second catheters each have a torqueability ratio of 1:1 between the distal and proximal ends. 
     
     
         48 . The catheter system of  claim 45 , wherein the key joint component is keyed to the first and second catheters such that the first side of the elongated body of the first catheter faces the first side of the elongated body of the second catheter. 
     
     
         49 . The catheter system of  claim 48 , wherein, when keyed with the key joint component, the at least one pre-formed curves of the first and second catheters curve in substantially opposite directions. 
     
     
         50 . The catheter system of  claim 45 , further comprising a delivery lumen configured to surround at least a portion of the elongated bodies of both the first and second catheters when they are keyed by the key joint component. 
     
     
         51 . The catheter system of  claim 50 , wherein the first and second catheters are slideable relative to the delivery lumen, and
 wherein the distal ends of the first and second catheters are configured to move away from each other as the distal ends slide out of the delivery catheter.   
     
     
         52 . The catheter system of  claim 50 , wherein the first and second catheters are rotatable relative to the delivery lumen while at least a portion of the elongated bodies of the first and second catheters are surrounded by the delivery lumen. 
     
     
         53 . The catheter system of  claim 50 , wherein the first and second catheters are not rotatable relative to the delivery lumen while at least a portion of the elongated bodies of the first and second catheters are surrounded by the delivery lumen. 
     
     
         54 . The catheter system of  claim 45 , wherein the first and second catheters each have a D-shaped cross-section. 
     
     
         55 . The catheter system of  claim 45 , wherein, for each of the first and second catheters, a curve direction of the at least one pre-formed curve is orthogonal to a normal vector of the first side that is flat. 
     
     
         56 . A method of using a catheter system comprising:
 providing a dual catheter system comprising:
 a first catheter and a second catheter, each of the first and second catheters having a proximal end, a distal end configured for insertion into a body lumen of a patient, an elongated body extending between the proximal and distal ends and having a cross-section that includes, over at least a portion of the elongated body, a first side that is flat and a second side on an opposite side of the cross-section from the first side, and 
 a key joint component configured to form a key joint with at least a portion of the elongated bodies near the proximal ends of both the first and second catheters, the portion of the elongated bodies that form the key joint including the first sides that are flat, the first and second catheters being rotationally fixed relative to the key joint component via the key joint, and the first side that is flat of the first catheter facing the first side that is flat of the second catheter; 
   advancing the distal ends of the first and second catheters through the body lumen of the patient; and   controlling a disposition of the first and second catheters such that at least one of the first and second catheters is directed toward one of a left bronchus and a right bronchus of the patient.   
     
     
         57 . The method of using a catheter system of  claim 56 , wherein the catheter system further comprises a delivery catheter having a proximal end, a distal end, and at least one lumen extending between the proximal and distal ends, the delivery catheter being configured to be positioned at least partially within the body lumen and to surround at least a portion of the elongated bodies of the first and second catheters. 
     
     
         58 . The method of using a catheter system of  claim 57 , wherein the advancing of the distal ends of the first and second catheters includes advancing the distal ends of the first and second catheters past the distal end of the delivery catheter,
 wherein the distal ends of the first and second catheters move away from each other as they advance past the distal end of the delivery catheter.   
     
     
         59 . The method of using a catheter system of  claim 56 , wherein each of the first and second catheters further includes a pre-formed curve near the distal end of the first and second catheter. 
     
     
         60 . The method of using a catheter system of  claim 58 , wherein each of the first and second catheters have a torqueability ratio of 1:1. 
     
     
         61 . The method of using a catheter system of  claim 56 , wherein, for each of the first and second catheters, a curve direction of the at least one pre-formed curve is orthogonal to a normal vector of the first side that is flat.