Percutaneous catheter and guidewire having filter and medical device deployment capabilities

• US 6,027,520 A
• Filed: 04/05/1999
• Issued: 02/22/2000
• Est. Priority Date: 05/08/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Embol X Inc (Edwards Lifesciences Corporation)
• Inventors: Tsugita, Ross S., Maahs, Tracy D., Jang, Yue-Teh
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/287,217
• Time in Patent Office: 323 Days
• Field of Search: 606/200, 606/191, 606/198, 606/159, 128/898
• US Class Current: 606/200
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• 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 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

An apparatus and method for treating stenosed blood vessels is provided, more particularly a percutaneous catheter, including a filter for capturing loose embolic material, used to deliver a stent, preferably within the ascending aorta, the aortic arch, or the carotid arteries. The catheter includes an expandable stent deployed on an inflatable balloon, or alternatively a self-expanding stent. A filter assembly is provided either directly on the catheter, or in a separate sheath or on a guidewire. The filter assembly comprises an expansion frame, having filter mesh attached to it, disposed on a guidewire inserted through the catheter or sheath, or alternatively attached directly on a distal region of the catheter. The expansion frame comprises a structure which is activated from a contracted condition into an enlarged condition in a blood vessel, thereby traversing the vessel with the filter mesh. The expansion frame includes biased struts, a mechanically operated frame, and/or a fluid-operated frame. The catheter is percutaneously introduced into a blood vessel and directed to a target region. The stent is localized across the region, the filter assembly is opened, and the stent is deployed, substantially permanently engaging the walls of the blood vessel, thereby opening the stenosed region and/or containing aortic plaque.

Claims

1. A method of protecting a patient from embolization during a percutaneous procedure on a vessel, comprising the steps of:

providing a guidewire having proximal and distal ends, a proximal and a distal region, an expandable filter associated with the distal region, and a removable sheath which covers the expandable filter and is slidable over the guidewire;

introducing the distal end of the guidewire into the patient'"'"'s vessel with the sheath covering the expandable filter, and positioning the filter downstream of a region of interest, wherein the sheath and guidewire cross the region of interest;

sliding the sheath toward the proximal end of the guidewire and removing the sheath from the vessel, wherein the expandable filter is uncovered;

deploying the filter;

advancing over the guidewire a stent-deployment catheter to the region of interest; and

expanding the stent at the region of interest,

wherein embolic material is generated and captured before the expandable filter is removed from the patient'"'"'s vessel.

2. The method of claim 1, further comprising the steps of:

removing the stent &

deployment catheter from the vessel;

advancing the sheath into the vessel over the guidewire until the sheath covers the expandable filter; and

removing the guidewire and sheath from the vessel.

3. The method of claim 1, wherein the stent is deployed by inflation of a balloon.

4. The method of claim 1, wherein the stent-deployment catheter is a rapid exchange catheter.

5. The method of claim 1, wherein the expandable filter comprises a plurality of struts, each strut having a proximal end in contact with the guidewire and a distal end in contact with the guidewire, and wherein the struts expand to the shape of an eggbeater.

6. The method of claim 1, wherein the expandable filter includes a filter mesh.

7. The method of claim 1, wherein the expandable filter comprises a plurality of radially biased struts.

8. The method of claim 1, wherein the expandable filter comprises a plurality of radially expandable struts which are operable to expand radially outwardly.

9. A percutaneous system having filter and stent deployment capabilities, comprising:

a guidewire having proximal and distal ends, a proximal and distal region, and an expandable filter associated with the distal region;

a sheath which is shaped to receive the guidewire and retain the filter in a contracted condition, and to slidably release the filter to an expanded condition when the sheath moves toward the proximal end of the guide wire;

a catheter having a proximal and a distal end, a proximal and a distal region, and a lumen which slidably receives the guidewire; and

an expandable stent disposed about the distal region of the catheter, the stent having a first diameter which permits intraluminal delivery of the stent into a body passageway and which places the stent in close proximity to the catheter, and having a second expanded diameter adapted to substantially engage a wall of the body passageway,

wherein, during use, the guidewire is positioned across a region of interest, the filter is expanded, and the stent is deployed within the region of interest and remains in place after removal of the catheter from the vessel.

10. The system of claim 9 wherein the expandable filter comprises an expansion frame and a filter mesh attached to the expansion frame.

11. The system of claim 10, wherein the expansion frame comprises a plurality of struts which, upon activation, bend outwardly to the enlarged condition.

12. The system of claim 11, wherein the guidewire includes a distal segment which can be moved longitudinally relative to a proximal segment, and wherein the proximal end of each strut is in contact with the proximal segment and a distal end of each strut is in contact with the distal segment, and wherein the struts expand radially when the distal segment is pulled toward the proximal region of the catheter.

13. The system of claim 10, wherein the expansion frame comprises radially biased struts attached to an outer surface of the catheter.

14. The system of claim 13, wherein a proximal end of each strut is in contact with the catheter and the distal end of each strut is in contact with the catheter, and wherein the struts expand to the shape of an eggbeater.

15. The system of claim 10, wherein the expansion frame comprises an inflation seal.

16. The system of claim 15, further comprising an inflation system comprising a first lumen adapted to receive pressurized fluid and a second lumen adapted to evacuate gas, and wherein the inflation seal further includes an entry port in fluid communication with the first lumen of the inflation system and an exit port in fluid communication with the second lumen of the inflation system, so that when fluid is advanced through the first lumen, the fluid enters the inflation seal and forces gas from the inflation seal through the second lumen, thereby purging the system of gas.

17. The system of claim 15, wherein the inflation seal comprises a tubular balloon which encloses a chamber and wherein the entry port and exit port are in close proximity, and wherein a septum is disposed between the entry and exit ports.

18. The system of claim 9, wherein the stent and the filter are self-expanding.

19. The system of claim 9, wherein the stent is removable.

20. The system of claim 9, wherein the stent is self-expanding.

21. The system of claim 9, wherein the stent comprises stainless steel material.

22. The system of claim 9, wherein the stent comprises nitinol material.

23. The system of claim 9, wherein the stent has a shape selected from the group consisting of a tube, a sheet, a wire, a mesh, and a spring.

24. The system of claim 9, wherein the sheath is shaped to receive the catheter and retain the stent at the first diameter.