Exchange method for emboli containment

• US 6,544,276 B1
• Filed: 03/27/1998
• Issued: 04/08/2003
• Est. Priority Date: 05/20/1996
• Status: Expired due to Fees

• Current Assignee: Kardiametrics LLC (IPNav)
• Original Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Inventors: Azizi, Gholam-Reza Zadno
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US09/049,712
• Time in Patent Office: 1,838 Days
• Field of Search: 600/585, 600/434, 604/96-1-1, 604/164.01, 604/164.13, 604/523, 604/528, 604/537, 604/264, 606/159, 606/167, 606/191-200, 606/213, 623/1-1-, 623/1--, 128/898
• US Class Current: 606/159
• 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 method of performing treatment in a blood vessel while isolating emboli to a portion of the blood vessel, the method comprising the steps of:

(a) delivering a guidewire having a proximal end and a distal end into the vasculature of a patient until the distal end is near to a treatment site in the blood vessel, the distal end of the guidewire having an occlusive device thereon, the occlusive device being actuatable between an expanded state in which the occlusive device engages at least a portion of the walls of the blood vessel, and a nonexpanded state in which the occlusive device does not engage the walls of the blood vessel;

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

(c) performing a first therapy treatment which results in the presence of emboli in the blood vessel at the treatment site;

(d) removing the first therapy catheter from the guidewire;

(e) delivering a second therapy catheter comprising an elongate catheter shaft having a proximal end, a distal end, and at least one lumen, over the guidewire until the distal end of the second therapy catheter is near to the treatment site;

(f) performing a second therapy treatment which results in the presence of emboli in the blood vessel at the treatment site;

(g) removing the second therapy catheter from the guidewire;

(h) delivering an emboli removal device comprising an elongate catheter shaft having a proximal end, a distal end, and at least one lumen, over the guidewire until the distal end of the emboli removal device is near to the treatment site; and

(i) removing emboli from the blood vessel through a lumen of the emboli removal device;

wherein the occlusive device is in its expanded state distal to the treatment site continuously at least from step (c) to step (i) to isolate the emboli at the treatment site.

2. The method of claim 1, wherein the occlusive device is an inflatable balloon.

3. The method of claim 1, wherein the occlusive device is a self-expanding member.

4. The method of claim 1, wherein the occlusive device is a mechanically deployed member.

5. The method of claim 1, wherein the first therapy catheter is delivered independently of the guidewire.

6. The method of claim 1, wherein the first therapy catheter is delivered simultaneously with the guidewire.

7. The method of claim 1, wherein the first therapy catheter is delivered while the occlusive device is in its nonexpanded state.

8. The method of claim 1, wherein the first therapy catheter has a dilatation balloon with a first diameter mounted on its distal end for compressing plaque found on the walls of the blood vessel.

9. The method of claim 8, wherein the second therapy catheter has a dilatation balloon with a second diameter larger than the first diameter mounted on its distal end for compressing plaque found on the walls of the blood vessel.

10. The method of claim 1, wherein the emboli removal device is an aspiration catheter.

11. A method of performing treatment in a blood vessel while isolating emboli to a portion of the blood vessel, the method comprising the steps of:

(a) delivering a guidewire having a proximal end and a distal end into the vasculature of a patient until the distal end is near to a treatment site in the blood vessel, the distal end of the guidewire having an occlusive device thereon, the occlusive device being actuatable between an expanded state in which the occlusive device engages at least a portion of the walls of the blood vessel, and a nonexpanded state in which the occlusive device does not engage the walls of the blood vessel;

(b) delivering a therapy catheter comprising an elongate catheter shaft having a proximal end and a distal end into the vasculature until the distal end of the therapy catheter is near to the treatment site;

(c) actuating the occlusive device at a location distal to the treatment site from its nonexpanded state to its expanded state;

(d) performing treatment on the treatment site with the therapy catheter, said treatment resulting in emboli in the vessel proximal to the actuated occlusive device;

(e) removing the therapy catheter from the vasculature and from the guidewire;

(f) delivering an emboli removal device having a proximal end and a distal end into the vasculature until the distal end of the emboli removal device is near to the treatment site and proximal to the occlusive device;

(g) removing emboli from the treatment site with the emboli removal device; and

(h) de-actuating the occlusive device;

wherein the occlusive device is maintained in its expanded state continuously from step (c) through step (g) to isolate emboli to the treatment site proximal to the occlusive device.

12. The method of claim 11, wherein the occlusive device is an inflatable balloon.

13. The method of claim 11, wherein the occlusive device is a self-expanding member.

14. The method of claim 11, wherein the occlusive device is a mechanically deployed member.

15. The method of claim 11, wherein the therapy catheter is delivered independently of the guidewire.

16. The method of claim 11, wherein the therapy catheter is delivered simultaneously with the guidewire.

17. The method of claim 11, wherein the therapy catheter is delivered while the occlusive device is in its nonexpanded state.

18. The method of claim 11, wherein the therapy catheter is a dilatation catheter.

19. The method of claim 11, wherein the therapy catheter performs treatment selected from the group consisting of stent delivery, drug delivery, atherectomy, shock wave generation, laser ablation, ultrasound ablation, vibration delivery and embolization element delivery for treatment of an aneurysm.

20. The method of claim 11, wherein the therapy catheter includes a lumen which is sized to override the guidewire.

21. The method of claim 11, wherein the emboli removal device is an aspiration catheter.

22. The method of claim 21, wherein the aspiration catheter is delivered over the guidewire.

23. The method of claim 11, further comprising, between steps (e) and (f), the steps of:

(i) delivering a second therapy catheter comprising an elongate catheter shaft having a proximal end and a distal end into the vasculature until the distal end of the second therapy catheter is near to the treatment site;

(j) performing treatment on the treatment site with the second therapy catheter, said treatment resulting in emboli in the vessel proximal to the actuated occlusive device; and

(k) removing the second therapy catheter from the vasculature.

24. A method for exchanging catheters while isolating emboli to a working area in a blood vessel, comprising:

delivering a guidewire having a proximal end and a distal end into the blood vessel until the distal end of the guidewire is near to a desired working area, the distal end having an occlusive device thereon;

delivering a first catheter having a proximal end and a distal end over the guidewire until the distal end of the first catheter is near to the desired working area;

actuating the occlusive device at a location distal to the desired working area such that the device at least partially obstructs blood flow through the vessel;

performing treatment in the working area with the first catheter while continuously maintaining actuation of the occlusive device, said treatment resulting in emboli within the working area isolated proximal to the occlusive device;

removing the first catheter from the guidewire while continuously maintaining actuation of the occlusive device;

delivering an aspiration catheter having a proximal and a distal end over the guidewire while continuously maintaining actuation of the occlusive device 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.

25. The method of claim 24, wherein the first catheter is delivered independently of the guidewire.

26. The method of claim 24, wherein the first catheter is delivered simultaneously with the guidewire.

27. The method of claim 24, wherein the first catheter is delivered prior to actuating the occlusive device.

28. The method of claim 24, further comprising removing the aspiration catheter from the guidewire.

29. The method of claim 28, further comprising de-actuating the occlusive device prior to removing the aspiration catheter.

30. The method of claim 28, further comprising delivering a second catheter over the guidewire and performing a second treatment to the blood vessel.

31. The method of claim 30, further comprising re-actuating the occlusive device after delivering the second catheter over the guidewire and continuously maintaining actuation of the occlusive device during said second treatment.

32. A method for exchanging catheters, comprising:

delivering a guidewire having a proximal end and a distal end into the blood vessel until the distal end of the guidewire is near to a desired working area, the distal end having an occlusive device thereon;

delivering a first catheter having a proximal end and a distal end over the guidewire until the distal end of the first catheter is near to the desired working area;

expanding the occlusive device at a location distal to the desired working area such that the device at least partially obstructs blood flow through the vessel;

performing treatment in the working area with the first catheter while continuously maintaining the occlusive device in its expanded state, said treatment resulting in emboli within the working area;

removing the first catheter from the guidewire while continuously maintaining the occlusive device in its expanded state;

delivering an emboli removal device over the guidewire while continuously maintaining the occlusive device in its expanded state; and

removing said emboli from the working area.

33. A method for exchanging catheters in a blood vessel, comprising:

delivering a guidewire having a proximal end and a distal end into the blood vessel until the distal end of the guidewire is near to a desired working area, the distal end having an occlusive device thereon;

actuating the occlusive device at a location distal to the desired working area such that the occlusive device inhibits emboli from moving past the occlusive device;

delivering a first catheter having a proximal end and a distal end over the guidewire until the distal end of the first catheter is near to the desired working area;

performing a first treatment in the working area with the first catheter while the occlusive device is actuated to inhibit emboli from moving past the occlusive device;

removing the first catheter from the guidewire while the occlusive device is actuated;

delivering a second catheter ;

over the guidewire while the occlusive device is actuated; and

performing a second treatment in the working area with the second catheter while the occlusive device is actuated to inhibit emboli from moving past the occlusive device.

34. The method of claim 33, wherein the treatment performed by one of the first catheter and the second catheter is aspiration.

35. The method of claim 33, wherein one of the first catheter and the second catheter deploys a stent.

36. The method of claim 35, wherein the other of the first catheter and the second catheter is an infusion catheter.

37. The method of claim 36, further comprising aspirating the working area to extract debris therefrom.

38. The method of claim 33, wherein one of the first catheter and the second catheter is an infusion catheter.

39. The method of claim 33, wherein one of the first catheter and the second catheter is a dilatation balloon catheter.

40. The method of claim 33, wherein the actuating of the occlusive device is performed after delivering the first catheter.

41. The method of claim 33, wherein the guidewire is hollow.

42. The method of claim 41, wherein the occlusive device is a balloon.

43. The method of claim 33, wherein the occlusive device is a filter.

44. The method of claim 43, wherein the filter is self-actuating.

45. The method of claim 43, wherein the filter is mechanically-deployed.