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

• US 6,558,367 B1
• Filed: 05/19/2000
• Issued: 05/06/2003
• Est. Priority Date: 10/17/1997
• Status: Expired due to Term

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Micro Therapeutics, Inc. (Medtronic Plc)
• Inventors: Walker, Blair, Perl, John, Cragg, Andrew H., Wallace, George, Greff, Richard J., Pecor, Robert
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/573,154
• Time in Patent Office: 1,082 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, 604/183, 604/537, 604/284, 604/171, 604/167.01, 604/167.02, 604/167.05, 604/167.06, 604/246, 604/249, 604/256, 604/36, 604/101.04, 604/95.01, 604/94.02, 600/139, 606/191, 606/192, 606/194, 606/213, 606/198, 606/200
• US Class Current: 604/523
• 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 system useful for controlling solidification in vivo of liquid embolic compositions which catheter system comprises:

a multiple lumen catheter having a first lumen and a second lumen for delivery of fluid, the multiple lumen catheter includes an inner tube and an outer tube coaxially surrounding the inner tube;

a first fluid delivery port positioned for delivery of fluid to the first lumen;

a second fluid delivery port positioned for delivery of fluid to the second lumen;

a liquid supply connected to the first fluid delivery port for delivery of a liquid embolic composition through the first lumen into a vascular site;

a liquid embolic composition in the liquid supply;

a solidification agent supply connected to the second fluid delivery port for delivery of a solidification agent through the second lumen to the vascular site;

a solidification agent in the solidification agent supply, wherein the solidification agent and the liquid embolic composition selected to enhance solidification of the liquid embolic composition when the solidification agent and the liquid embolic composition are in contact; and

an actuator, wherein the actuator includes a substantially flat rectangular manipulator which is grasped by the physician to move the first lumen longitudinally within the second lumen.

2. The catheter system according to claim 1, wherein distal motion of the first lumen with respect to the second lumen is limited by engagement of the actuator with a locking mechanism.

3. The catheter system according to claim 1, wherein the catheter has an anti-kinking feature to prevent kinking of the first lumen as it is pushed distally within the second lumen.

4. A catheter system useful for controlling solidification in vivo of liquid embolic compositions which catheter system comprises:

a multiple lumen catheter having a first lumen and a second lumen for delivery of fluid, the multiple lumen catheter includes an inner tube and an outer tube coaxially surrounding the inner tube;

a first fluid delivery port positioned for delivery of fluid to the first lumen;

a second fluid delivery port positioned for delivery of fluid to the second lumen;

a liquid supply connected to the first fluid delivery port for delivery of a liquid embolic composition through the first lumen into a vascular site;

a liquid embolic composition in the liquid supply;

a solidification agent supply connected to the second fluid delivery port for delivery of a solidification agent through the second lumen to the vascular site;

a solidification agent in the solidification agent supply, wherein the solidification agent and the liquid embolic composition selected to enhance solidification of the liquid lembolic composition when the solidification agent and the liquid embolic composition are in contact;

an actuator; and

a plurality of stops which limit longitudinal motion of the first lumen with respect to the second lumen.

5. A catheter system useful for controlling solidification in vivo of liquid embolic compositions which catheter system comprises:

a multiple lumen catheter having an inner tube and an outer tube coaxially surrounding the inner tube, the inner tube and the outer tube forming a first lumen and a second lumen for delivery of a fluid, and wherein the inner tube is movable from an extended position in which the inner tube extends from a distal end of the outer tube to a retracted position in which a distal end of the inner tube is inside the distal end of the outer tube;

a first fluid delivery port positioned for delivery of fluid to the first lumen;

a second fluid delivery port positioned for delivery of fluid to the second lumen;

a liquid supply connected to the first fluid delivery port for delivery of a liquid embolic composition through the first lumen;

a liquid embolic composition in the liquid supply, wherein the liquid embolic composition is injected into a vascular site and solidifies to fully or partially occlude the vascular site; and

a solidification agent supply connected to the second fluid delivery port for delivery of a solidification agent through the second lumen, wherein the solidification agent and the embolic composition selected to enhance solidification of the liquid embolic composition when the solidification agent and the liquid embolic composition are in contact.

6. The catheter system according to claim 5, further comprising a locking mechanism for locking a position of the inner tube with respect to the outer tube at a plurality of relative positions.

7. The catheter system according to claim 5, wherein the relative motion of the inner and outer tubes from the extended position to the retracted position detaches a solidified mass of the embolic composition from the multiple lumen catheter.

8. The catheter system according to claim 5, wherein the first lumen and the second lumen have outlets, and the outlet of the first lumen and the outlet of the second lumen of the multiple lumen catheter are longitudinally movable with respect to one another to change relative longitudinal positions of the outlets of the first and second lumens to control solidification of the liquid embolic composition.

9. The catheter system according to claim 5, wherein the liquid embolic composition comprises a water-insoluble, biocompatible polymer dissolved in a biocompatible solvent and the catheter is compatible with the biocompatible solvent.

10. The catheter system according to claim 9, wherein the biocompatible solvent is DMSO.

11. The catheter system according to claim 10, wherein the multiple lumen catheter is DMSO compatible.

12. The catheter system according to claim 9, wherein the biocompatible polymer is water insoluble and the solidification agent is selected from the group consisting of water, saline, Dextrose 5% water, lactated Ringers solution, and aqueous based contrast agents.

13. The catheter system according to claim 5, further comprising an actuator.

14. The catheter system according to claim 5, wherein the first and second lumens having a plurality of segments having different flexibilities.

15. The catheter system according to claim 5, wherein the first and second lumens are rigid at a proximal end and flexible at a distal end.

16. A catheter system useful for controlling solidification in vivo of liquid embolic compositions comprising:

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

a source of a liquid embolic composition in fluid communication with the lumen of the first tube, the liquid embolic composition in the liquid embolic composition source comprising a biocompatible, water-insoluble polymer dissolved in DMSO wherein the liquid embolic composition is injected into a vascular site and solidifies to fully or partially occlude the vascular site;

a second tube formed of a solidification agent compatible material and coaxially surrounds the first tube, the second tube having a lumen, wherein the first tube is movable from an extended position in which the first tube extends from a distal end of the second tube to a retracted position in which a distal end of the first tube is inside the distal end of the second tube;

a solidification agent source in fluid communication with the lumen of the second tube, the source adapted to contain a solidification agent, the solidification agent and the liquid embolic composition selected so that the solidification agent enhances solidification of the liquid embolic composition when the solidification agent and the liquid embolic composition are in contact;

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

a first fluid delivery port connected to the lumen of the first tube for delivery of the liquid embolic composition into the vascular site, the first delivery port formed of a DMSO compatible material; and

a second fluid delivery port connected to the lumen of the second tube for delivery of the solidification agent to the vascular site.

17. The catheter system according to claim 16, further comprising a locking mechanism for locking a longitudinal position of the first tube with respect to the second tube.

18. The catheter system according to claim 16, wherein the second tube has a distal end including a plurality of side holes for delivery of the solidification agent.

19. The catheter system according to claim 16, wherein the first and second tubes each have a proximal portion with a durometer of between about 40 Shore D and 90 Shore D.

20. The catheter system according to claim 16, wherein the first and second tubes each have a distal portion with a durometer of between about 40 Shore A and 45 Shore D.

21. A method of treating aneurysms with a liquid embolic composition comprising:

inserting a multiple lumen catheter endovascularly to an aneurysm site;

injecting a liquid embolic composition through a first lumen of the multiple lumen catheter and into the aneurysm site, wherein the liquid embolic composition is injected into the aneurysm site and solidifies to fully or partially occlude the aneurysm site; and

injecting a solidification agent through a second lumen of the multiple lumen catheter and into the aneurysm site, the solidification agent and the liquid embolic composition selected so that the solidification agent enhances solidification of the liquid embolic composition when the solidification agent and the liquid embolic composition are in contact.

22. The method of treating aneurysms according to claim 21, wherein the solidification agent is selected to enhance solidification of the liquid embolic composition when the solidification agent and the liquid embolic composition are in contact.

23. The method of treating aneurysms according to claim 21, wherein the multiple lumen catheter is a coaxial catheter and the solidification agent is injected through an annulus between an inner and an outer tube of the coaxial catheter.

24. The method of treating aneurysms according to claim 21, 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.

25. The method of treating aneurysms according to claim 24, wherein the liquid embolic composition and the solidification agent are injected when the outlets of the first and second lumens are longitudinally spaced with respect to each other.

26. The method of treating aneurysms according to claim 25, wherein the outlets of the first and second lumens of the multiple lumen catheter are manipulated with respect to one another to detach a solidified mass of embolic composition from the multiple lumen catheter.

27. The method of treating aneurysms according to claim 21, wherein a fluid is injected 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.

28. The method of treating aneurysms according to claim 21, wherein the injected liquid embolic composition includes a biocompatible polymer composition dissolved in a solvent.

29. The method of treating aneurysms according to claim 21, wherein the first lumen is flushed with a barrier fluid prior to injection of the liquid embolic composition to prevent aqueous fluids in the first lumen from coming into contact with the liquid lembolic composition passing through the first lumen.

30. The method of treating aneurysms according to claim 29, wherein the barrier fluid includes a solvent.

31. The method of treating aneurysms according to claim 30, wherein the solidification agent is injected through the second lumen during the flushing of the first lumen with the barrier fluid to lower a concentration of the solvent being delivered to the patient.

32. The method of treating aneurysms according to claim 21, further comprising injecting the solidification agent in a pulsating manner.

33. The method of treating an aneurysm according to claim 21, further comprising injecting a barrier fluid through the first lumen to remove any aqueous material from the inner tube.

34. The method of treating an aneurysm according to claim 21, further comprising injecting a dilution agent through the second lumen and into the aneurysm site before or as soon as the barrier fluid begins to exit the first lumen.

35. The method of treating an aneurysm according to claim 21, further comprising injecting a contrast agent to help visualize flow characteristics of the aneurysm site and determine optimum catheter placement within the aneurysm site.

36. The method of treating an aneurysm according to claim 21, wherein the liquid embolic composition is injected first and the solidification agent is injected second.

37. The method of treating an aneurysm according to claim 21, wherein the liquid embolic composition and the solidification agent are injected in a serial or iterative process.

38. A method for reducing toxic effects of a non-aqueous solvent delivered intravascularly which method comprises:

positioning a multiple lumen catheter into a vascular site of a mammal;

injecting a composition comprising a non-aqueous solvent through a first lumen of the multiple lumen catheter and into the vascular site; and

injecting an aqueous solution through at least a second lumen of the multiple lumen catheter and into the vascular site to dilute the non-aqueous solvent and reduce toxic effects of the non-aqueous solvent on surrounding tissue.

39. The method for reducing toxic effects of a non-aqueous solvent according to claim 38, wherein the non-aqueous solvent is DMSO.

40. A kit for controlling delivery in vivo of a liquid embolic composition to a target site in a body comprising:

a liquid embolic composition, wherein the liquid embolic composition is injected into the vascular site and solidifies to fully or partially occlude the vascular site; and

a multiple lumen catheter for delivery of the liquid embolic composition through a first lumen and into the target site and delivery of a solidification agent through a second lumen and into the target site, wherein the multiple lumen catheter has an inner tube and an outer tube coaxially surrounding the inner tube, the inner tube and the outer tube forming a first lumen and a second lumen for delivery of a fluid, and wherein the inner tube is movable from an extended position in which the inner tube extends from a distal end of the outer tube to a retracted position in which a distal end of the inner tube is inside the distal end of the outer tube.

41. The kit according to claim 40, wherein the multiple lumen catheter includes an inner tube longitudinally movable within a coaxial outer tube.

42. The kit according to claim 41, wherein the multiple lumen catheter further comprises a connector introducing the liquid embolic composition and the solidification agent to the first and second lumens, the connector including an anti-kinking mechanism allowing the inner tube to move within the outer tube without kinking.

43. The kit according to claim 40, wherein the liquid embolic composition comprises a biocompatible, water insoluble polymer dissolved in DMSO.

44. A catheter system useful for controlling solidification in vivo of liquid embolic compositions which catheter system comprises:

a multiple lumen catheter having an inner tube and an outer tube coaxially surrounding the inner tube, the inner tube and the outer tube forming a first lumen and a second lumen for delivery of a fluid, and wherein the inner tube is movable from an extended position in which the inner tube extends from a distal end of the outer tube to a retracted position in which a distal end of the inner tube is inside the distal end of the outer tube;

a first fluid delivery port positioned for delivery of fluid to the first lumen;

a second fluid delivery port positioned for delivery of fluid to the second lumen;

a liquid supply connected to the first fluid delivery port for delivery of a liquid embolic composition through the first lumen;

a liquid embolic composition in the liquid supply, wherein the liquid embolic composition comprises a water-insoluble, biocompatible polymer dissolved in a biocompatible solvent and the catheter is compatible with the biocompatible solvent, and the liquid embolic composition is injected into a vascular site and solidifies to fully or partially occlude the vascular site; and

a solidification agent supply connected to the second fluid delivery port for delivery of a solidification agent through the second lumen, wherein the solidification agent is selected from the group consisting of water, saline, Dextrose 5% water, lactated Ringers solution, and aqueous based contrast agents, and wherein the solidification agent and the embolic composition are selected to enhance solidification of the liquid embolic composition when the solidification agent and the liquid embolic composition are in contact.