Exchange method for emboli containment

• US 20020065507A1
• Filed: 01/22/2001
• Published: 05/30/2002
• Est. Priority Date: 05/20/1996
• Status: Active Grant

• Current Assignee: Kardiametrics LLC (IPNav)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Zadno-Azizi, Gholam-Reza
• Granted Patent: US 6,986,778 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• 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 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61M 2025/0018 having a plug, e.g. an inflatable plug for closing catheter lumens
• CPC Class Codes: A61M 2025/09008 having a balloon
• CPC Class Codes: A61M 2025/09116 Design of handles or shafts or gripping surfaces thereof for manipulating guide wires
• CPC Class Codes: A61M 2025/09125 Device for locking a guide wire in a fixed position with respect to the catheter or the human body
• CPC Class Codes: A61M 2025/09175 : having specific characteristics at the distal tip
• CPC Class Codes: A61M 2025/1015 : having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1079 : having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1081 : having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2025/1093 : having particular tip characteristics
• CPC Class Codes: A61M 25/0009 : Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0026 : Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/005 : with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0054 : with regions for increasing flexibility
• CPC Class Codes: A61M 25/0075 : Valve means
• CPC Class Codes: A61M 25/09 : Guide wires
• CPC Class Codes: A61M 25/09033 : with fixed mandrils, e.g. mandrils fixed to tip; Tensionable wires
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 25/10184 : Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/10185 : Valves
• CPC Class Codes: A61M 25/1027 : Making of balloon catheters
• CPC Class Codes: A61M 25/104 : used for angioplasty

Abstract

The present invention provides a method for exchanging catheters while containing emboli within a blood vessel such as a saphenous vein graft, coronary artery, carotid artery, or other similar vessels. A guidewire is inserted through the vasculature of a patient until it reaches a desired treatment site. A therapy catheter is then inserted over the guidewire until the distal end of the therapy catheter reaches the treatment site. The guidewire has a distally mounted balloon which is inflated to occlude the blood vessel. Then, the therapy catheter provides means for treating the vessel at the treatment site. After treatment, the therapy catheter is removed from the guidewire and exchanged with an aspiration catheter which rides over the guidewire until the distal end of the aspiration catheter reaches the treatment site. The aspiration catheter applies negative pressure to remove any emboli formed by the treatment procedure.

Claims

1. A catheter exchange method, comprising the steps of:

introducing a guidewire having a proximal and a distal end into the vasculature of a patient until the distal end is near to a treatment site;

delivering a first catheter comprising an elongate catheter shaft having a proximal end, a distal end, and at least one lumen extending therethrough, over the proximal end of the guidewire until the distal end of the first catheter is near to the treatment site;

removing the first catheter from the guidewire;

delivering a second catheter comprising an elongate catheter shaft having a proximal end, a distal end, and at least one lumen extending therethrough, over the proximal end of the guidewire until the distal end of the second catheter is near to the treatment site.

2. The method of claim 1, wherein an occlusion device is mounted on the distal end of the guidewire.

3. The method of claim 2, further comprising the step of actuating the occlusion device to at least partially block the flow of blood moving downstream.

4. The method of claim 2, wherein the occlusion device is an occlusion balloon.

5. The method of claim 2, wherein the occlusion device is a self-expanding member.

6. The method of claim 2, wherein the occlusion device is a mechanically deployed member.

7. The method of claim 1, wherein the first catheter is a therapy catheter which produces emboli in the vasculature.

8. The method of claim 7, wherein the therapy catheter has a dilatation balloon mounted on a distal end of the catheter for compressing plaque found on the walls of the vasculature.

9. The method of claim 7, wherein the therapy catheter has a balloon mounted on a distal end of the catheter for deploying a stent to the walls of the vasculature.

10. The method of claim 7, wherein the therapy catheter is a vibration delivery catheter.

11. The method of claim 7, wherein the therapy catheter is a drug delivery catheter.

12. The method of claim 7, wherein the therapy catheter deploys embolization elements for treatment of an aneurysm.

13. The method of claim 1, wherein the second catheter is an aspiration catheter.

14. The method of claim 1, wherein the treatment site is an occlusion.

15. The method of claim 1, wherein the treatment site is an aneurysm.

16. The method of claim 1, wherein the treatment site is in a saphenous vein graft.

17. The method of claim 1, wherein the treatment site is in a coronary artery.

18. The method of claim 1, wherein the guidewire has an outer diameter of about 0.014 inches.

20. The method of claim 19, further comprising the steps of:

removing the aspiration catheter from the guidewire;

advancing a second therapy catheter over the guidewire and performing a second treatment to the blood vessel.

21. The method of claim 20, further comprising the step of de-actuating the occlusive device prior to removing the aspiration catheter.

22. The method of claim 20, further comprising the step of re-actuating the occlusive device after advancing the second therapy catheter over the guidewire.

24. The method of claim 23, wherein the emboli are created by dislodging plaque from a lesion formed on a wall of the blood vessel.

25. The method of claim 24, wherein the plaque is dislodged by a dilatation balloon compressing the plaque against the wall, the dilatation balloon mounted on the distal end of a therapy catheter advanced over the guidewire.

26. The method of claim 24, wherein the plaque is dislodged by targeting of ultrasounds.

27. The method of claim 24, wherein the plaque is dislodged by releasing drug delivery fluids.

28. The method of claim 23, wherein the emboli are created by a catheter advanced over the guidewire deploying embolization elements to an aneurysm.

19. A method for exchanging catheters while isolating emboli to a working area in a blood vessel, comprising the steps of:

delivering a guidewire having a proximal and a distal end into the blood vessel, the distal end having an occlusive device mounted thereon, wherein the occlusive device is positioned at a point distal to a desired working area;

advancing a therapy catheter having a proximal and a distal end over the guidewire such that the distal end of the therapy catheter is located within the desired working area;

actuating the occlusive device such that the device contacts the walls of the vessel to at least partially obstruct blood flow through the vessel and isolate emboli to the working area;

performing treatment to the blood vessel using therapy means located at the distal end of the therapy catheter, said treatment creating emboli within the blood vessel;

removing the therapy catheter from the guidewire;

advancing an aspiration catheter having a proximal and a distal end over the guidewire such that the distal end of the aspiration catheter is located within the working area; and

applying negative pressure to the aspiration catheter to remove emboli isolated within the working area.

23. A method of containing emboli within a working area of a blood vessel, comprising the steps of:

delivering a guidewire having an occlusive device mounted on a distal end of the guidewire;

deploying the occlusive device at a position downstream from a desired working area such that blood flow is at least partially occluded by the occlusive device;

creating emboli within the working area of the blood vessel; and

advancing an aspiration catheter over the guidewire for removing the emboli from the blood vessel.