Balloon catheter for occluding aneurysms of branch vessels

• US 5,795,331 A
• Filed: 01/24/1994
• Issued: 08/18/1998
• Est. Priority Date: 01/24/1994
• Status: Expired due to Term

• Current Assignee: Micro Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: Micro Therapeutics, Inc. (Medtronic Plc)
• Inventors: Cragg, Andrew H., Kagan, Jonathan
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/148,374
• Time in Patent Office: 1,667 Days
• Field of Search: 604/48, 604/49, 604/53, 604/96, 604/101, 606/191, 606/192, 606/194, 606/195, 606/198
• US Class Current: 604/103.01
• 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 17/12036 partial occlusion
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

A method and apparatus for delivering occluding agents through an opening in a blood vessel wall and into an aneurysm chamber or a branch vessel by introducing a balloon catheter, inflating the balloon to seal the blood vessel lumen around the vessel opening, and delivering the occluding agent through the opening. The inflation of the balloon positions an exit port laterally in the vessel in alignment with the vessel opening for delivering of the occluding agent therethrough. In one embodiment, the balloon encircles the distal end segment of the catheter body, and the delivery exit port is supported on the inflated surface of the balloon. In a second embodiment, the balloon is formed and extends around a major circumferential section of the distal end segment, and the delivery exit port is formed in the remaining minor circumferential section for lateral movement into alignment with the vessel opening as the balloon fills the blood vessel on inflation. The inflated balloon maintains the occluding agent therein until it forms an occluding cast, and the balloon wall shapes the occluding cast into conformance with the blood vessel lumen. The catheter body is formed with lumens for balloon inflation/deflation, the passage over a guide wire, the delivery of the occluding agent and the venting during delivery or aspiration prior to delivery. More than one delivery exit port and associated lumen may be provided for venting during delivery and/or for the delivery of a two component occluding agent. The catheter body and the balloon are preferably formed integrally of coaxial tubes with delivery/venting lumens formed in the outer tube and a common inner lumen for inflation/deflation of the balloon, terminating in a self sealing distal valve for receiving the guide wire. Liquid occluding agents or mechanical thrombus forming devices my be delivered thereby into the aneurysm chamber or branch vessel to occlude it.

Claims

1. A method of forming an occluding cast through a vessel opening in the side wall of a main blood vessel for occluding a peripheral vessel or aneurysm outside of the opening without occluding the main vessel, comprising the steps of:

sealing the main vessel lumen and side walls from the vessel opening into the aneurysm or peripheral vessel to thereby shield the main vessel wall adjacent to the vessel openings;

delivering an occluding agent through the vessel opening into the aneurysm chamber or peripheral vessel; and

maintaining the seal until occlusion is effected or the occluding agent is stabilized, whereby an occluding cast is formed by or about the occluding agent within the aneurysm or peripheral vessel and seals the vessel opening without occluding the main vessel.

2. The method of claim 1 further comprising the step of:

perfusing the vessel lumen to allow blood flow through it in perfusion channel sealed from the vessel opening during delivery of the occluding agent and maintenance of the seal.

3. The method of claim 1 further comprising the step of:

venting through the vessel opening leading to the aneurysm chamber or peripheral vessel during delivery of the occluding agent.

4. The method of claim 1 further comprising the step of:

aspirating the contents of the aneurysm chamber or peripheral vessel prior to delivery of the occluding agent.

5. The method of claim 1 wherein said sealing and delivering steps further comprise the steps of:

introducing a balloon catheter having an inflatable balloon into a position in the main vessel adjacent to the vessel opening;

introducing means for delivering an occluding agent through a delivery exit port into a position in the main vessel adjacent to the vessel opening to deliver the occluding agent through the vessel opening;

inflating the balloon to fill the blood vessel and to seal the delivery exit port and the vessel opening from the blood vessel lumen; and

delivering the occluding agent through the delivery lumen and delivery exit port and through the vessel opening.

6. The method of claim 5 further comprising the step of:

rotating the balloon catheter to rotate the inflated balloon across the vessel opening after delivering the occluding agent, whereby the vessel opening is sealed from the main vessel lumen as the occluding agent forms the occluding cast.

7. The method of claim 1 wherein the delivering step further comprises:

delivering an occluding agent having a liquid form through the vessel opening, the occluding agent being reactive to irradiating light for solidifying as a solid occluding cast; and

further comprising the step of;

irradiating the occluding agent delivered through the vessel opening with irradiating light directed through the vessel opening sufficiently to effect solidification of the delivered liquid occluding agent.

8. The method of claim 1 wherein the delivering step further comprises:

delivering an occluding agent having a solid fibrous or particulate form through the vessel opening to form a solid mass of thrombus, the occluding agent effective to coagulate blood around the fibers or particles and to form a solid thrombus mass within the aneurysm chamber or peripheral vessel functional as a solid occluding cast.

9. The method of claim 1 wherein the delivering step further comprises:

delivering an occluding agent comprising one or more compressible shaped members having an expanded form when unconfined and compressible for delivery through a confined space and through the vessel opening, and specifically a coil or coils of noble metals.

10. The method of claim 1 wherein the delivering step further comprises:

delivering an occluding agent having a liquid form through the vessel opening, the occluding agent being reactive on exposure to form the solid occluding cast.

11. The method of claim 1 wherein said sealing and delivering steps further comprise the steps of:

introducing a balloon catheter having an inflatable balloon and a delivery lumen extending therethrough terminating in a delivery exit port into a position in the main vessel adjacent to the opening;

orienting the delivery exit port to the opening;

inflating the balloon to fill the blood vessel and to seal the delivery exit port and the opening from the blood vessel lumen; and

delivering the occluding agent through the delivery lumen and delivery exit port and into the opening.

12. The method of claim 1 wherein said sealing and delivery steps further comprise the stops of:

introducing a balloon catheter having an inflatable balloon and a delivery lumen and a further lumen extending therethrough terminating in a delivery exit port and a further exit port into a position in the main vessel adjacent to the vessel opening;

orienting the exit ports to the vessel opening;

inflating the balloon to fill the blood vessel and to seal the exit ports and the vessel opening from the blood vessel lumen;

delivering the occluding agent through the delivery lumen and delivery exit port and through the vessel opening; and

venting the contents of the aneurysm chamber or peripheral vessel through the vessel opening and through the further exit port and further lumen during delivery of the occluding agent through the delivery lumen and delivery exit port and through the vessel opening, whereby the occluding agent displaces the contents of the peripheral vessel or aneurysm distal to the vessel opening to form the occluding cast therein.

13. The method of claim 12 further comprising the step of:

aspirating the contents of the aneurysm chamber or branch vessel through one of the delivery or further lumens and the vessel opening before delivering the occluding agent.

14. The method of claim 1 wherein said sealing and delivery steps further comprise the steps of:

introducing a balloon catheter having an inflatable balloon and first and second delivery lumens extending therethrough terminating in first and second delivery exit ports into a position in the main vessel adjacent to the vessel opening;

orienting the delivery exit ports to the vessel opening;

inflating the balloon to fill the blood vessel and to seal the delivery exit ports and the vessel opening from the blood vessel lumen;

delivering a first component of the occluding agent through the first delivery lumen and first delivery exit port and into the opening; and

delivering a second component of the occluding agent through the second delivery lumen and second delivery exit port and into the opening, whereby the first and second components of the occluding agent mix together in the peripheral vessel or aneurysm distal to the vessel opening to form the occluding cast therein.

15. The method of claim 14 further comprising the step of:

aspirating the contents of the aneurysm chamber or branch vessel through one of the first or second delivery lumens and the vessel opening before delivering the first and second components of the occluding agent.

16. Apparatus for forming an occluding cast through a vessel opening in the side wall of a main blood vessel for occluding a peripheral vessel or aneurysm chamber outside of the vessel opening without occluding the vessel lumen comprising:

means positionable within the main vessel lumen for temporarily sealing the main vessel side wall and vessel lumen from the vessel opening into the aneurysm or peripheral vessel to thereby shield the main vessel wall adjacent to the vessel opening;

means for delivering an occluding agent through the vessel opening leading to the aneurysm chamber or peripheral vessel; and

means for maintaining the sealing of the main vessel wall and vessel lumen until occlusion is effected or the occluding agent is stabilized, whereby an occluding cast is formed by or about the occluding agent within the aneurysm chamber or peripheral vessel and seals the vessel opening without occluding the main vessel.

17. The apparatus of claim 16 further comprising:

means for aspirating through the vessel opening leading to the aneurysm chamber or peripheral vessel before delivering the occluding agent.

18. The apparatus of claim 16 further comprising:

means for perfusing the vessel lumen to allow blood flow through it in perfusion channel sealed from the vessel opening during delivery of the occluding agent and maintenance of the seal.

19. The apparatus of claim 16 further comprising:

means for venting through the vessel opening leading to the aneurysm chamber or peripheral vessel during delivery of the occluding agent.

20. The apparatus of claim 16 wherein the occluding agent has a liquid form for delivery through the vessel opening, the occluding agent being reactive to irradiating light for solidifying as a solid occluding cast, and further comprising:

means for irradiating the occluding agent delivered through the vessel opening with light directed through the vessel opening sufficiently to effect solidification of the delivered liquid occluding agent.

21. The apparatus of claim 16 wherein the occluding agent has a liquid form for delivery through the vessel opening, the occluding agent being reactive on exposure to form the solid occluding cast.

22. The apparatus of claim 16 wherein the occluding agent has a solid particulate form for delivery through the vessel opening, the occluding agent effective to coagulate blood around the particles and to form a solid thrombus mass within the aneurysm chamber or peripheral vessel functional as a solid occluding cast.

23. The apparatus of claim 16 wherein the occluding agent further comprises a compressible shaped member having an expanded form when unconfined and compressible for delivery through a confined space and through the vessel opening, and specifically a coil or coils of noble metals.

24. The apparatus of claim 16 wherein said sealing means further comprises:

an elongated balloon catheter having an inflatable balloon;

means for introducing the balloon catheter into a position in the main vessel adjacent to the vessel opening; and

means for inflating the balloon to fill the blood vessel lumen and to seal the delivery exit port and the vessel opening from the blood vessel lumen; and

wherein said delivering means further comprises;

means for positioning a delivery exit port in position in the main vessel adjacent to the vessel opening to deliver the occluding agent through the vessel opening; and

means for delivering the occluding agent through said delivery exit port and through said vessel opening.

25. The apparatus of claim 24 further comprising:

means for rotating the balloon catheter to rotate the inflated balloon across the vessel opening after delivering the occluding agent, whereby the vessel opening is sealed from the main vessel lumen as the occluding agent forms the occluding cast.

26. The apparatus of claim 24 further comprising:

means for perfusing the vessel lumen to allow blood flow through it in perfusion channel sealed from the vessel opening during delivery of the occluding agent and maintenance of the seal by said inflated balloon.

27. The apparatus of claim 16 wherein said sealing and delivery means further comprise:

a balloon catheter having an inflatable balloon and a delivery lumen and a further lumen extending therethrough terminating in a delivery exit port and a further exit port;

means for introducing the balloon catheter into a position in the main vessel lumen adjacent to the vessel opening and for orienting the delivery and further exit ports to the vessel opening;

means for inflating the balloon to fill the blood vessel and to seal the exit ports and the vessel opening from the blood vessel lumen;

means for delivering the occluding agent through the delivery lumen and delivery exit port and through the vessel opening; and

means for venting the contents of the aneurysm chamber or peripheral vessel through the vessel opening and through the further exit port and further lumen during delivery of the occluding agent through the delivery lumen and delivery exit port and through the vessel opening, whereby the occluding agent displaces the contents of the peripheral vessel or aneurysm chamber distal to the vessel opening to form the occluding cast therein.

28. The apparatus of claim 27 further comprising:

means for aspirating the contents of the aneurysm chamber or branch vessel through one of the delivery or further lumens and the vessel opening before delivering the occluding agent.

29. The apparatus of claim 16 wherein:

said sealing means further comprise;

a balloon catheter having an inflatable balloon and first and second delivery lumens extending therethrough terminating in first and second delivery exit ports;

means for introducing the balloon catheter into a position in the main vessel adjacent to the vessel opening and orienting the delivery exit ports to the vessel opening; and

means for inflating the balloon to fill the blood vessel and to seal the delivery exit ports and the vessel opening from the blood vessel lumen; and

said delivery means further comprise;

means for delivering a first component of the occluding agent through the first delivery lumen and first delivery exit port and into the vessel opening; and

means for delivering a second component of the occluding agent through the second delivery lumen and second delivery exit port and into the vessel opening, whereby the first and second components of the occluding agent mix together in the peripheral vessel or aneurysm chamber distal to the vessel opening to form the occluding cast therein.

30. The apparatus of claim 29 further comprising:

means for aspirating the contents of the aneurysm chamber or branch vessel through one of the first or second delivery lumens and the vessel opening before delivering the first and second components of the occluding agent.

31. A balloon catheter for delivering an occluding agent in situ into a vessel opening in the side wall of a main blood vessel and for forming an occluding cast in situ for occluding a peripheral, branch blood vessel or aneurysm chamber distal to the vessel opening without occluding the main blood vessel lumen comprising:

an elongated catheter body having a proximal end segment and a distal end segment adapted to be introduced into the main blood vessel lumen in relation to the vessel opening leading to the branch blood vessel or aneurysm chamber;

an inflatable balloon attached at the distal end segment of said catheter body into which inflation fluid may be delivered to inflate the balloon and withdrawn to deflate the balloon;

delivery means having a delivery lumen extending from the proximal to the distal end segment of the catheter body and having an exit port in communication therewith for delivering an occluding agent to the vessel opening when positioned with respect thereto; and

inflation means for inflating the balloon with inflation fluid to effect the inflation thereof within the main blood vessel lumen to form a seal of the main blood vessel around and on either side of the vessel opening and to position said delivery exit port in alignment with the vessel opening, whereby the occluding agent may be delivered through the vessel opening.

32. The balloon catheter of claim 31 wherein said inflation means further comprises:

an inflation lumen extending from the proximal segment to the distal segment of said catheter body and adapted to be coupled at the proximal segment to a source of inflation fluid and at the distal segment to said interior inflation space; and

said delivery means delivery lumen extends from the proximal segment to the distal segment of said catheter body and is adapted to be coupled at the proximal segment to a source of an occluding agent and at the distal segment to said delivery exit port situated alongside said balloon.

33. The balloon catheter of claim 32 wherein:

said balloon is formed of a balloon wall extending along said distal end segment of said catheter body and around the circumference thereof, whereby said balloon is inflatable outwardly from said distal end segment against the wall of a blood vessel on operation of said inflation means; and

said delivery lumen is formed on and extends along said balloon wall a predetermined distance and is formed with said delivery exit port which faces away from said balloon and said distal end segment, whereby inflation of said balloon laterally extends said delivery exit port against a vessel opening in the wall of a blood vessel.

34. The balloon catheter of claim 33 further comprising:

a further lumen extending from the proximal segment to the distal segment of said catheter body and formed on and extending along said balloon wall a predetermined distance to a further exit port which faces away from said balloon and said distal end segment, whereby inflation of said balloon laterally extends said further exit port against said vessel opening;

means at the proximal end segment of said catheter body selectively adapted to couple said further lumen to deliver a component of a two component occluding agent through said further exit port and through said vessel opening, to aspirate the contents of the aneurysm chamber or branch vessel through one of the delivery or further lumens and the vessel opening before delivering the occluding agent, and to vent the contents of the aneurysm chamber or peripheral vessel through the further vessel opening and through the further exit port and further lumen during delivery of the occluding agent through the delivery lumen and delivery exit port and through the vessel opening, whereby the occluding agent displaces the contents of the peripheral vessel or aneurysm distal to the vessel opening to form the occluding cast therein.

35. The balloon catheter of claim 32 wherein:

said balloon is formed of a balloon wall extending along said distal end segment of said catheter body and around at least a major section of the circumference thereof, whereby said balloon is inflatable outwardly from said distal end segment against the wall of a blood vessel on operation of said inflation means to fill the blood vessel lumen and displace the minor section of the circumference of said distal end segment of said catheter body against the blood vessel wall; and

said delivery exit port is formed in said minor section of the circumference of said distal end segment a predetermined distance along the length of said balloon and faces away from said balloon, whereby inflation of said balloon laterally extends said delivery exit port against a vessel opening in the wall of a blood vessel.

36. The balloon catheter of claim 35 further comprising:

a further lumen extending from the proximal segment to the distal segment of said catheter body to a further exit port, said further exit port formed in said minor section of the circumference of said distal end segment a predetermined distance along the length of said balloon facing away from said balloon, whereby inflation of said balloon laterally extends said delivery exit port against the vessel opening in the wall of a blood vessel; and

means at the proximal end segment of said catheter body selectively adapted to couple said further lumen to deliver a component of a two component occluding agent through said further exit port and through said vessel opening, to aspirate the contents of the aneurysm chamber or branch vessel through one of the delivery or further lumens and the vessel opening before delivering the occluding agent, and to vent the contents of the aneurysm chamber or peripheral vessel through the further vessel opening and through the further exit port and further lumen during delivery of the occluding agent through the delivery lumen and delivery exit port and through the vessel opening, whereby the occluding agent displaces the contents of the peripheral vessel or aneurysm distal to the vessel opening to form the occluding cast therein.

37. The balloon catheter of claim 35 further comprising:

means for forming a perfusior, channel between said balloon wall extending along said distal end segment of said catheter body and the main blood vessel wall sealed from said vessel opening upon inflation of said balloon.

38. The balloon catheter of claim 35 wherein:

said balloon is formed of a tubular balloon wall adhered to said catheter body along said distal end segment of said catheter body in said minor section of the circumference thereof to form an adhered balloon section, whereby said balloon is inflatable outwardly from said distal end segment against the wall of a blood vessel on operation of said inflation means to fill the blood vessel lumen and displace the minor section of the circumference of said distal end segment of said catheter body and said adhered balloon section against the blood vessel wall; and

said delivery exit port is formed in said minor section of the circumference of said distal end segment a predetermined distance along the length of and through said adhered balloon section and faces away from said balloon, whereby inflation of said balloon laterally extends said delivery exit port against a vessel opening in the wall of a blood vessel.

39. The balloon catheter of claim 31 further comprising:

means for forming a perfusion channel between said balloon wall extending along said distal end segment of said catheter body and the main blood vessel wall sealed from said vessel opening upon inflation of said balloon.

40. The balloon catheter of claim 31 wherein:

said distal segment end of said catheter body includes a distal extension terminating in a tip extending distally to said balloon; and

said inflation means further comprises an inflation lumen extending from the proximal segment to the distal tip of said catheter body through said inflation lumen adapted to be coupled at the proximal segment end to a source of inflation fluid and at the distal segment end to said interior inflation space of said balloon; and

further comprising;

a guide wire for providing guidance of said distal end segment into position with respect to a vessel opening;

means at said proximal end segment of said catheter body for receiving said guide wire in said inflation lumen; and

valve means formed in said distal tip and across said inflation lumen for sealing said inflation lumen from the loss of inflation fluid during inflation of said balloon and for receiving said guide wire extending distally therethrough during introduction and positioning of said balloon catheter.

41. The balloon catheter of claim 31 wherein:

said distal segment end of said catheter body includes a distal extension terminating in a tip extending distally to said balloon; and

said inflation means further comprises an inflation lumen extending from the proximal segment to the distal tip of said catheter body through said inflation lumen adapted to be coupled at the proximal segment end to a source of inflation fluid and at the distal segment end to said interior inflation space of said balloon; and

further comprising;

a twist wire for providing guidance of said distal end segment into position with respect to a vessel opening and for providing torque transfer from the proximal segment of said catheter body to said distal tip to provide rotational movement thereof;

means at said proximal end segment of said catheter body for receiving said twist wire in said inflation lumen; and

means formed in said distal tip and across said inflation lumen for sealing said inflation lumen from the loss of inflation fluid during inflation of said balloon and for receiving and attaching said twist wire extending distally therethrough during introduction and positioning of said balloon catheter.

42. The apparatus of claim 31 wherein the occluding agent has a liquid form for delivery through the vessel opening, the occluding agent being reactive to irradiating light for solidifying as a solid occluding cost, and said apparatus further comprises:

a source of irradiating light;

means for directing said irradiating light into the occluding agent delivered through the vessel opening sufficiently to effect solidification of the delivered liquid occluding agent.

43. The apparatus of claim 31 wherein:

said catheter body further comprises an inner elongated tube and an outer elongated tube in co-axial alignment to form an inner lumen and an outer lumen; and

said balloon is formed of said outer tube in said distal end segment thereof; and

wherein;

said inflation means comprises said outer lumen; and

said delivery lumen is formed within said outer tube and extends form said proximal to said distal segment terminating in said delivery exit port.