Method and apparatus for emboli containment

• US 20030208222A1
• Filed: 02/21/2001
• Published: 11/06/2003
• Est. Priority Date: 05/20/1996
• Status: Abandoned Application

• Current Assignee: Gholam-Reza Zadno-Azizi
• Original Assignee: Gholam-Reza Zadno-Azizi
• Inventors: Zadno-Azizi, Gholam-Reza
• Application Number:
  US09/790,220
• Publication Number:
  US 20030208222A1
• Time in Patent Office: Days
• US Class Current: 606/194
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• 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 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61B 2017/22055 with three or more balloons
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61M 2025/0018 having a plug, e.g. an inflatable plug for closing catheter lumens
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• 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 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/1045 : for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations
• 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 2025/109 : having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• 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 25/0012 : with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• 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 25/0029 : characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0032 : characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0053 : having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/0054 : with regions for increasing flexibility
• CPC Class Codes: A61M 25/0068 : Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0075 : Valve means
• 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 25/1018 : Balloon inflating or inflation-control devices
• CPC Class Codes: A61M 25/1027 : Making of balloon catheters
• CPC Class Codes: A61M 25/104 : used for angioplasty
• CPC Class Codes: B29C 55/04 : uniaxial, e.g. oblique

Abstract

Disclosed herein is a catheter for use in an emboli containment system. In one embodiment, the catheter has a tubular body with a metallic braid construction. Two lumens extend through the tubular body, the lumen being in a side-by-side configuration. One of the lumens functions as an inflation lumen, and is in fluid communication with an inflatable balloon mounted on the distal end of the catheter. The second lumen is adapted to receive other therapeutic catheters which comprise the emboli containment system. In another embodiment, apparatus is provided for treatment of a stenosis in a lumen in a blood-carrying vessel comprising a main catheter and a therapeutic catheter. The main catheter comprises a first flexible elongate tubular member having proximal and distal extremities. A sealing element is carried on the distal extremity of the first flexible elongate tubular member. The first flexible elongate tubular member has a main lumen therein extending from the proximal extremity to the distal extremity and exits through the distal extremity. An adapter is mounted on the proximal extremity of the first flexible elongate tubular member. The therapeutic catheter comprises a second flexible elongate tubular member having proximal and distal extremities. An element for performing work is mounted on the distal extremity of the second flexible elongate tubular member. An adapter is mounted on the proximal extremity of the second flexible elongate tubular member. The second flexible elongate tubular member is slidably mounted in the main lumen of the first elongate tubular member. A mechanism is carried by the first flexible elongate tubular member for causing the sealing element to form an occlusion in the vessel proximal of the stenosis to provide a working space distal of the sealing element. A mechanism is coupled to the attachment of the therapeutic catheter for causing operation of the element for performing work in the working space adjacent the stenosis.

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.