Guiding catheter for positioning a medical device within an artery

• US 6,179,851 B1
• Filed: 06/15/1999
• Issued: 01/30/2001
• Est. Priority Date: 07/17/1996
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Barbut, Denise R., Root, Jonathan D., Pastrone, Giovanni
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Trinh, (Vikki) Hoa B.
• Application Number:
  US09/335,849
• Time in Patent Office: 595 Days
• Field of Search: 606/159, 606/200, 606/170, 606/194, 606/198, 606/153, 128/898, 604/104-107, 604/22, 604/96, 623/1-1, 623/2
• US Class Current: 606/159
• 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 device, 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. A guiding catheter for positioning a medical device within an artery, said guiding catheter comprising:

a flexible elongate member having a distal region adapted to enter an artery, a proximal region, a lumen extending from the proximal region to the distal region, and an outer surface with an opening in fluid communication with the lumen, wherein the lumen is adapted to receive a medical device which can pass through the opening to access the lumen of the artery, wherein a portion of the lumen adjacent and proximal the opening communicates directly with the opening such that the opening is freely accessible from said portion of the lumen; and

an expandable filter disposed within the distal region of the elongate member and distal the opening, the filter being expandable between a contracted condition and an enlarged condition, the filter having a first distal edge circumferentially in contact with the outer surface of the flexible elongate member and an expandable proximal edge.

2. The guiding catheter of claim 1, further comprising the medical device inserted through the lumen of the flexible elongate member.

3. The guiding catheter of claim 2, wherein the medical device is an atherectomy catheter.

4. The guiding catheter of claim 1, wherein the expandable filter further comprises an expansion mechanism which is expandable between a contracted condition and an enlarged condition.

5. The guiding catheter of claim 4, wherein the expandable filter further comprises a mesh having a first edge attached to the expansion mechanism and a second edge disposed circumferentially about and closely associated with the outer surface of the flexible elongate member.

6. The guiding catheter of claim 4, wherein the expansion mechanism comprises an inflation seal.

7. The guiding catheter of claim 6, 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.

8. A guiding catheter for positioning a medical device within an artery, said guiding catheter comprising:

a flexible elongate member having an outer surface, a distal region adapted to enter an artery, a proximal region, and a lumen extending from the proximal region to the distal region, wherein the lumen is adapted to receive a medical device; and

at least one positioning member disposed within the distal region of the flexible elongate member, wherein during use said positioning member is deployed to stabilize or deflect the elongate member within the vessel lumen and away from a longitudinal center line of the vessel.

9. The guiding catheter of claim 8, wherein a distal segment of the flexible elongate member extends beyond the at least one positioning member and is bent at an angle of greater than 10°

so as to direct a medical device toward the vessel wall.

10. The guiding catheter of claim 8, wherein the at least one positioning member comprises a mechanical extending arm operable from the proximal region of the elongate member.

11. The guiding catheter of claim 8, wherein the at least one positioning member comprises a balloon which is inflatable by a separate lumen within the guiding catheter.

12. The guiding catheter of claim 11, wherein the positioning member comprises an elastomeric balloon.

13. The guiding catheter of claim 11, wherein the at least one positioning member comprises an elastomeric balloon.

14. The guiding catheter of claim 11, wherein the at least one positioning member comprises a balloon.

15. The guiding catheter of claim 8, further comprising an expandable filter disposed within the distal region of the flexible elongate member.

16. The guiding catheter of claim 15, wherein the expandable filter is downstream of the at least one positioning member.

17. A method for protecting a patient from embolization during a percutaneous medical procedure, comprising the steps of:

providing a guiding catheter comprising a flexible elongate member having a lumen extending from a proximal to a distal region of the elongate member, and having an expandable filter within the distal region of the elongate member;

advancing the distal region of the guiding catheter to a region of interest within a vessel of the patient;

expanding the expandable filter downstream of the region of interest;

deploying a medical instrument through an opening of the elongate member; and

performing a percutaneous procedure with the medical instrument on the vessel upstream of the filter, wherein embolic material dislodged by the procedure is captured by the filter.

18. The guiding catheter of claim 17, wherein the therapeutic catheter is an atherectomy catheter.

19. The method of claim 17, wherein the guiding catheter further comprises a positioning member within the distal region of the elongate member.

20. The method of claim 19 further comprising the step of deploying the positioning member to deflect or stabilize the guiding catheter within the vessel.

21. The method of claim 20, wherein the positioning member is upstream of the expandable filter.

22. The method of claim 17, wherein the medical instrument is a therapeutic catheter.

23. The method of claim 22, wherein the therapeutic catheter is an atherectomy catheter.

24. A guiding catheter for positioning a medical device within an artery, said guiding catheter comprising:

a flexible elongate member having a distal region adapted to enter an artery, a proximal region, a lumen extending from the proximal region to the distal region, and an outer surface with an opening in fluid communication with the lumen, wherein the lumen is adapted to receive a medical device which can pass through the opening to access the lumen of the artery, wherein a portion of the lumen adjacent and proximal the opening communicates directly with the opening such that the opening is freely accessible from said portion of the lumen;

an expandable filter disposed within the distal region of the elongate member and distal the opening, the filter being expandable between a contracted condition and an enlarged condition, the filter having a first distal edge circumferentially in contact with the outer surface of the flexible elongate member and an expandable proximal edge; and

the medical device received by the lumen of the flexible elongate member and passing through the opening to access the lumen of the artery.

25. The guiding catheter of claim 24, wherein a distal segment of the flexible elongate member proximal the expandable filter is bent at an angle of greater than 10°

so as to direct a medical device toward the vessel wall.

26. The guiding catheter of claim 24, further comprising at least one positioning member disposed within the distal region of the flexible elongate member, wherein during use said positioning member is deployed to deflect the elongate member within the vessel lumen.

27. The guiding catheter of claim 26, wherein the at least one positioning member comprises a mechanical extending arm operable from the proximal region of the elongate member.

28. The guiding catheter of claim 26, wherein the at least one positioning member comprises a balloon which is inflatable by a separate lumen within the guiding catheter.

29. The guiding catheter of claim 28, wherein the balloon is elastomeric.

30. The guiding catheter of claim 26, wherein the at least one positioning member is proximal to the expandable filter.

31. The guiding catheter of claim 24, wherein the medical device is an atherectomy assembly comprising means for plaque removal and trapping means.

32. The guiding catheter of claim 24, wherein the medical device is bent at an angle.

33. The guiding catheter of claim 32 wherein the medical device is bent at an angle of less than 90°

.

34. The guiding catheter of claim 24, further comprising at least one positioning member disposed within the distal region of the flexible elongate member, wherein during use said positioning member is deployed to stabilize the elongate member within the vessel lumen.