Catheter system and method for injection of a liquid embolic composition and a solidification agent

• US 6,964,657 B2
• Filed: 02/11/2003
• Issued: 11/15/2005
• Est. Priority Date: 10/17/1997
• Status: Expired due to Fees

• Current Assignee: Micro Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: Micro Therapeutics, Inc. (Medtronic Plc)
• Inventors: Wallace, George, Walker, Blair, Perl, John, Cragg, Andrew H., Greff, Richard J., Pecor, Robert
• Primary Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US10/361,851
• Publication Number:
  US 20030225391A1
• Time in Patent Office: 1,008 Days
• Field of Search: 604/264, 604/48, 604/507, 604/508, 604/265, 604/523, 604/533, 604/518, 604/93.01, 604/57, 604/246, 604/249, 604/256, 604/36, 604/183, 604/537, 604/284, 604/171, 604/167.01, 604/101.04, 604/167.02, 604/167.05, 604/167.06, 604/95.01, 604/95.02, 600/139, 606191-194, 606/213, 606/198, 606/200
• US Class Current: 604/508
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10

Abstract

A catheter according to the present invention includes a multiple lumen catheter for delivery of a liquid embolic composition through a first lumen and delivery of a solidification agent through a second lumen. The catheter allows adjustment of the relative longitudinal position of the two lumens to control the solidification of the embolic composition within a blood vessel. The multiple lumen catheter system is used by inserting the catheter endovascularly into an aneurysm site and injecting a liquid embolic composition through the first lumen while injecting a solidification agent through the second lumen to wash the area of the aneurysm of blood which has become saturated with solvent, while replacing it with a fresh solidification agent. The controlled solidification of the liquid embolic composition by use of the solidification agent allows the aneurysm to be filled precisely and rapidly even when the aneurysm is located such that gravity does not cause the liquid embolic composition to flow into the aneurysm.

Claims

1. A catheter for controlling solidification in vivo of liquid embolic compositions comprising:

(a) a first tube formed of a DMSO compatible material the first tube having a lumen;

(b) a source of liquid embolic composition in fluid communications with the lumen of the first tube, the liquid embolic composition comprising a biocompatible, water-insoluble polymer dissolved in DMSO, the first tube formed of a DMSO compatible material;

(c) a second tube having a lumen, wherein the first tube is movable from an extended position in which a distal end of the first tube extends beyond a distal end of the second tube and a retracted position in which a distal end of the second tube and a retracted position in which a distal end of the second tube is even with or extends beyond a distal end of the first tube;

(d) a solidification agent source in fluid communication with the lumen of the second tube, the solidification agent selected to enhance solidification of the liquid embolic composition;

(e) an actuator for sliding the first tube longitudinally with respect to the second tube;

(f) a first fluid delivery port connected to a lumen of the first tube for delivery of a liquid embolic composition; and

(g) a second fluid delivery port connected to a lumen of the second tube for delivery of the solidification agent.

2. The catheter according to claim 1, further comprising a locking mechanism for locking a longitudinal position of the first tube with respect to the second tube.

3. The catheter according to claim 1, wherein a distal end of the second tube includes a plurality of side holes for delivery of the solidification agent.

4. A method for solidifying a liquid embolic composition comprising:

providing a multiple lumen catheter having a first tube forming a first lumen and a second tube forming a second lumen;

injecting a liquid embolic composition through the first lumen of the multiple lumen catheter with the first tube in an extended position at which a distal end of the first tube extends beyond a distal end of the second tube;

controlling the solidification of the liquid embolic composition to form a mass by injecting a solidification agent through a second lumen of the multiple lumen catheter;

detaching the solidified mass of liquid embolic composition by moving the first tube to a retracted position at which the distal end of the second tube is even with or extends beyond the distal end of the first tube; and

injecting a fluid through one of the first and second lumens to improve longitudinal motion of the outlets of the first and second lumens with respect to one another.

5. A catheter for controlling solidification in vivo of liquid embolic compositions comprising:

(a) a first tube formed of a DMSO compatible material the first tube having a lumen;

(b) a source of liquid embolic composition in fluid communications with the lumen of the first tube, the liquid embolic composition comprising a biocompatible, water-insoluble polymer dissolved in DMSO, the first tube formed of a DMSO compatible material;

(c) a second tube having a lumen, wherein the first tube is movable from an extended position in which a distal end of the first tube extends beyond a distal end of the second tube and a retracted position in which a distal end of the second tube and a retracted position in which a distal end of the second tube is even with or extends beyond a distal end of the first tube;

(d) a solidification agent source in fluid communication with the lumen of the second tube, the solidification agent selected to enhance solidification of the liquid embolic composition;

(e) an actuator for sliding the first tube longitudinally with respect to the second tube;

(f) a first fluid delivery port connected to a lumen of the first tube for delivery of a liquid embolic composition; and

(g) a second fluid delivery port connected to a lumen of the second tube for delivery of the solidification agent,

wherein the second tube coaxially surrounds the first tube.

6. The catheter according to claim 5, further comprising an anti-kinking mechanism for preventing kinking of the first tube as it slides in the second tube, the anti-kinking mechanism including a rigid tube connected to the first tube and slidable within a sleeve.

7. The catheter according to claim 5, wherein the first and second tubes each have a proximal portion with a durometer of between about 40 Shore D and 90 Shore D.

8. The catheter according to claim 7, wherein the first and second tubes each have a distal portion with a durometer of between about 40 Shore A and 45 Shore D.

9. The catheter according to claim 8, wherein a joint between the distal and proximal portions of the first tube is longitudinally displaced from a joint between the distal and proximal portions of the second tube at all relative positions of the catheter which are achieved by manipulation of the actuator.

10. A method for solidifying a biocompatible polymer comprising:

(a) providing a multiple lumen catheter having a first tube forming a first lumen and a second tube forming a second lumen;

(b) positioning a distal end of the multiple lumen catheter within or near a target site within a human body;

(c) injecting a liquid biocompatible polymer composition through the first lumen of the multiple lumen catheter and into the target site;

(d) injecting a solification agent throught the second lumen of the multiple lumen catheter and into the target side to solidify the liquid biocompatible polymer composition to form a mass at the target site; and

(e) injecting a fluid through one of the first and second lumens to improve longitudinal motion of the outlets of the first and second lumens with respect to one another;

wherein an outlet of the first lumen and an outlet of the second lumen of the multiple lumen catheter are longitudinally movable with respect to one another.

11. A method for solidifying a biocompatible polymer comprising:

(a) providing a multiple lumen catheter having a first tube forming a first lumen and a second tube forming a second lumen;

(b) positioning a distal end of the multiple lumen catheter within or near a target site within a human body;

(c) injecting a liquid biocompatible polymer composition through the first lumen of the multiple lumen catheter and into the target site;

(d) injecting a solidification agent through the second lumen of the multiple lumen catheter and into the target side to solidify the liquid biocompatible polymer composition to form a mass at the target site; and

(e) injecting a dilution agent through the second lumen and into the blood vessel site before or as soon as the barrier fluid begins to exit the first lumen.