Exchange method for emboli containment

• US 6,986,778 B2
• Filed: 01/23/2001
• Issued: 01/17/2006
• Est. Priority Date: 05/20/1996
• Status: Expired due to Fees

• Current Assignee: Kardiametrics LLC (IPNav)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Zadno-Azizi, Gholam-Reza
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US09/768,031
• Publication Number:
  US 20020065507A1
• Time in Patent Office: 1,820 Days
• Field of Search: 604 9601-109, 604/528, 604/19, 604/35, 606/1, 606/108, 606/151, 606/159, 606/167, 606/180, 606190-200, 606/170, 606/171, 600/434, 600/585
• US Class Current: 606/200
• 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 system for emboli containment, comprising:

a guidewire having a proximal end and a distal end;

an occlusive device connected to the distal end of the guidewire, the occlusive device being actuatable between an expanded state in which the occlusive device engages at least a portion of the walls of a blood vessel, and a nonexpanded state in which the occlusive device does not engage the walls of the blood vessel;

a first treatment catheter having a proximal end and a distal end and a lumen extending therethrough; and

a second treatment catheter having a proximal end and a distal end and a lumen extending therethrough;

wherein the first treatment catheter is adapted to be delivered over and then removed from the guidewire, and the second treatment catheter is adapted to be delivered over and then removed from the guidewire following removal of the first treatment catheter, and wherein the occlusive device is capable of maintaining its expanded state while the first treatment catheter is removed from the guidewire and while the second treatment catheter is delivered over the guidewire;

wherein the occlusive device is a self-expanding sealing member.

2. The catheter system of claim 1, further comprising a sleeve provided over the self-expanding sealing member, wherein removal of the sleeve actuates the self-expanding sealing member.

3. A catheter system for emboli containment, comprising:

a guidewire having a proximal end, a distal end, and a lumen extending therethrough;

an occlusive device connected to the distal end of the guidewire, the occlusive device being actuatable between an expanded state in which the occlusive device engages at least a portion of the walls of a blood vessel, and a nonexpanded state in which the occlusive device does not engage the walls of the blood vessel;

a first treatment catheter having a proximal end and a distal end and a lumen extending therethrough; and

a second treatment catheter having a proximal end and a distal end and a lumen extending therethrough;

wherein the first treatment catheter is adapted to be delivered over and then removed from the guidewire, and the second treatment catheter is adapted to be delivered over and then removed from the guidewire following removal of the first treatment catheter, and wherein the occlusive device is capable of maintaining its expanded state while the first treatment catheter is removed from the guidewire and while the second treatment catheter is delivered over the guidewire;

wherein the occlusive device is actuated by a pull wire extending through the lumen of the guidewire.

4. The catheter system of claim 3, wherein the occlusive device is a filter.

5. The catheter system of claim 4, wherein the first treatment catheter is a therapy catheter.

6. The catheter system of claim 5, wherein the second treatment catheter is an aspiration catheter.

7. The catheter system of claim 4, wherein the second treatment catheter is a therapy catheter.

8. The catheter system of claim 4, wherein the second treatment catheter is an aspiration catheter.

9. The catheter system of claim 4, further comprising a third treatment catheter having a proximal end and a distal end and a lumen extending therethrough, wherein the third treatment catheter is adapted to be delivered over and then removed from the guidewire following removal of the first treatment catheter and prior to delivery of the second treatment catheter.

10. The catheter system of claim 9, wherein the first treatment catheter has a dilatation balloon of a first diameter on its distal end, the third treatment catheter has a dilatation balloon of a second diameter on its distal end, the second diameter being larger than the first diameter, and the second treatment catheter is an aspiration catheter.

11. The catheter system of claim 4, wherein the guidewire includes a lumen extending therethrough.

12. A catheter system for emboli containment, comprising:

a guidewire having a proximal end and a distal end;

an occlusive device connected to the distal end of the guidewire, the occlusive device being actuatable between an expanded state in which the occlusive device engages at least a portion of the walls of a blood vessel, and a nonexpanded state in which the occlusive device does not engage the walls of the blood vessel; and

a catheter having a proximal end and a distal end and a lumen extending therethrough, the catheter being adapted to be delivered over and removed from the guidewire;

wherein the occlusive device is capable of maintaining its expanded state while the catheter is either advanced over or removed from the guidewire;

wherein the occlusive device is a self-expanding sealing member.

13. The catheter system of claim 12, further comprising a sleeve provided over the self-expanding sealing member, wherein removal of the sleeve actuates the self-expanding sealing member.

14. A catheter system for emboli containment, comprising:

a guidewire having a proximal end, a distal end, and a lumen extending therethrough;

an occlusive device connected to the distal end of the guidewire, the occlusive device being actuatable between an expanded state in which the occlusive device engages at least a portion of the walls of a blood vessel, and a nonexpanded state in which the occlusive device does not engage the walls of the blood vessel; and

a catheter having a proximal end and a distal end and a lumen extending therethrough, the catheter being adapted to be delivered over and removed from the guidewire;

wherein the occlusive device is capable of maintaining its expanded state while the catheter is either advanced over or removed from the guidewire;

wherein the occlusive device is actuated by a pull wire extending through the lumen of the guidewire.

15. The catheter system of claim 14, wherein the occlusive device is a filter.