Atherectomy device having trapping and excising means for removal of plaque from the aorta and other arteries

• US 5,662,671 A
• Filed: 07/17/1996
• Issued: 09/02/1997
• Est. Priority Date: 07/17/1996
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Embolx, Inc.
• Inventors: Sellers, James M., McKenzie, John, Barbut, Denise, Root, Jonathan D., Pastrone, Giovanni, Rizzari, Robert
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): MULCARE, NANCY C
• Application Number:
  US08/683,503
• Time in Patent Office: 412 Days
• Field of Search: 606/170, 606/159, 606/194, 604/22, 604/104-107, 604/95, 604/96, 604/268, 128/660, 128/341-344, 128/325
• US Class Current: 606/170
• CPC Class Codes: A61B 10/06 Biopsy forceps , e.g. with cup-shaped jaws
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 2010/0225 for taking multiple samples
• CPC Class Codes: A61B 2017/00287 Bags for minimally invasive surgery
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/32004 having a laterally movable cutting member at its most distal end which remains within the contours of said end
• CPC Class Codes: A61B 2017/320064 with tissue or sample retaining means
• CPC Class Codes: A61B 8/0808 for diagnosis of the brain
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• 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 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 2230/0067 : conical
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2230/008 : paraboloidal
• CPC Class Codes: A61M 2210/127 : Aorta
• CPC Class Codes: A61M 25/00 : Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00

Abstract

An arterial catheter system for removing plaque from the aorta and other arteries is disclosed. The system typically includes an elongate catheter member, a filtration apparatus disposed within the distal region, and an atherectomy assembly which includes a mechanism for trapping and holding mobile or fixed plaque and an excising mechanism for removing the plaque. In use, the catheter is positioned so that the atherectomy assembly lies within a region of interest, the filtration apparatus is deployed downstream of the region of interest, the plaque is trapped and held by a snare, vacuum, or other trapping means, and then the excising mechanism is activated to remove the plaque. Methods are also disclosed for removing plaque from the aorta and other arteries.

Claims

1. An arterial catheter system for removing plaque from the aorta or other arteries, said catheter system comprising:

a flexible elongate member having an outer surface, a distal region adapted to enter an artery, and a proximal region;

expansion means disposed within the distal region of the elongate member which is expandable between a contracted condition and an enlarged condition;

a mesh having a first edge attached circumferentially and continuously to the expansion means and a second edge disposed circumferentially about and in contact with the outer surface of the flexible elongate member; and

an atherectomy assembly disposed within the distal region of the elongate member, the atherectomy assembly comprising means for plaque removal and trapping means, wherein during use said first edge of said mesh is positioned at a distance from the outer surface of the flexible elongate member, and said plaque is trapped and held by the trapping means and excised from the arterial lumen by the means for plaque removal.

2. The arterial catheter of claim 1, wherein the expansion means comprises an umbrella frame having a plurality of arms which, upon activation, bend outwardly to the enlarged condition.

3. The arterial catheter of claim 1, further comprising one or more positioning fingers disposed within the distal region of the elongate member.

4. The arterial catheter of claim 1, wherein the flexible elongate member is equipped with steering capabilities.

5. The arterial catheter of claim 1, wherein the flexible elongate member extends through the mesh.

6. The arterial catheter of claim 1, wherein the flexible elongate member includes a housing having a cavity adapted to receive and store excised plaque material.

7. The arterial catheter of claim 1, wherein the expansion means comprises an inflation seal.

8. The arterial catheter of claim 7, wherein the trapping means comprises a suction device.

9. The arterial catheter of claim 7, wherein the means for plaque removal comprises a cutting blade.

10. The arterial catheter of claim 7, in the flexible elongate member further includes 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 flexible elongate member and an exit port in fluid communication with the second lumen of the flexible elongate member, 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.

11. The arterial catheter of claim 10, 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.

12. The arterial catheter of claim 7, further comprising a plurality of holding strings which attach the inflation seal to the flexible elongate member.

13. The arterial catheter of claim 7, wherein the trapping means comprises a snare.

14. The arterial catheter of claim 7, wherein the trapping means comprises a surface having an adjustable orifice.

15. The arterial catheter of claim 7, wherein the means for plaque removal comprises a snare.

16. The arterial catheter of claim 7, wherein the means for plaque removal comprises a surface having an adjustable orifice.

17. The arterial catheter of claim 7, wherein the means for plaque removal comprises a basket having an adjustable opening adapted to close about the plaque and excise a portion of the plaque by pinching.

18. The arterial catheter of claim 7, wherein the means for plaque removal comprises a plurality of claws which are movable between an open and a closed position.

19. The arterial catheter of claim 7, wherein the means for plaque removal comprises first and second substantially semispherical surfaces pivotally connected to the elongate member and movable between an open and closed position.

20. The arterial catheter of claim 7, wherein the means for plaque removal comprises a basket and a cutting wire having a first end anchored to the elongate member and a second end which is drawn in a proximal direction, wherein a segment of the cutting wire sweeps across the opening to the basket during operation.

21. The arterial catheter of claim 1, wherein the atherectomy assembly is disposed within the distal region of the elongate member and distal to the expansion means and mesh.

22. The arterial catheter of claim 1, wherein the atherectomy assembly is disposed within the distal region of the elongate member and proximal to the expansion means and mesh.

23. A method for removing plaque from the aorta or other arteries of a patient, comprising the steps of:

providing an arterial catheter system comprising a flexible elongate member having an outer surface, a distal region adapted to enter an artery, a proximal region, an atherectomy assembly disposed within the distal region of the elongate member, the atherectomy assembly comprising means for plaque removal and trapping means, and a filtration system comprising expansion means disposed about the distal region of the elongate member which is expandable between a contracted condition and an enlarged condition, and a mesh having a first edge attached circumferentially and continuously to the expansion means and a second edge disposed circumferentially about and in contact with the outer surface of the flexible elongate member;

introducing the distal region of the arterial catheter into a region of interest within the patient'"'"'s artery, through an incision in the femoral or brachial artery;

deploying the filtration system downstream of the plaque within the artery by expanding the expansion means until said first edge of said mesh is positioned at a distance from the outer surface of the flexible elongate member and said first edge achieves contact with the lumen of the artery;

contacting the atherectomy assembly with the plaque within the artery, wherein the plaque is trapped and held by the atherectomy assembly by use of the trapping means;

excising the plaque from the artery by operating the means for plaque removal while simultaneously operating the trapping means to secure the plaque;

contracting the expansion means to the contracted condition; and

removing the arterial catheter system and the plaque entrapped therein from the region of interest and the femoral artery.

24. The method of claim 23, wherein the region of interest is within the patient'"'"'s aorta, and wherein the filtration system is disposed within the distal region of the flexible elongate member and proximal to and downstream of the atherectomy assembly.

25. The method of claim 23, wherein the region of interest is within the patient'"'"'s carotid artery, and wherein the filtration system is disposed within the distal region of the flexible elongate member and distal to and downstream of the atherectomy assembly.

26. The method of claim 23, wherein the step of contacting the atherectomy assembly with the plaque includes the step of deploying one or more positioning fingers to bias the flexible elongate member toward or away from a plaque.

27. The method of claim 23, wherein the expansion means comprises an inflation seal.

28. The method of claim 27, wherein the flexible elongate member further includes 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 elongate member and an exit port in fluid communication with the second lumen of the elongate member, 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.

29. The method of claim 23, wherein the step of excising plaque from the artery further includes the step of using transcranial doppler ultrasound for cerebral monitoring of emboli.

30. The method of claim 23, wherein the step of contacting the atherectomy assembly with the plaque includes the step of operating a steering mechanism to maneuver the atherectomy assembly toward a plaque.

31. The method of claim 23, wherein the step of excising plaque further includes the step of guiding excised plaque to a cavity in the elongate member, said cavity being adapted to receive and store plaque material.

32. The method of claim 31, further comprising the step of grinding or abrading excised plaque material.

33. The method of claim 31, further comprising the step of aspirating the excised plaque material.

34. The method of claim 23, wherein the step of introducing the distal region of the arterial catheter into a region of interest includes the step of introducing the catheter into a vessel selected from the group consisting of the aorta, common carotid artery, external and internal carotid arteries, brachiocephalic trunk, middle cerebral artery, anterior cerebral artery, posterior cerebral artery, vertebral artery, basilar artery, subclavian artery, brachial artery, axillary artery, iliac artery, renal artery, femoral artery, popliteal artery, celiac artery, superior mesenteric artery, inferior mesenteric artery, anterior tibial artery, and posterior tibial artery.