Thrombectomy catheter

• US 20070060908A1
• Filed: 08/18/2005
• Published: 03/15/2007
• Est. Priority Date: 08/18/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Webster, Mark, Galdonik, Jason, Ogle, Matthew
• Granted Patent: US 7,938,820 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• 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 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22045 fixed to the catheter; guiding tip
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0052 Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• 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 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• 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

Abstract

Thrombectomy catheters are presented that have curved tip portions. A suction lumen extends from at or near the proximal end of the catheter to a suction port at or near the tip portion of the catheter. The curves of the thrombectomy catheter can be selected to place a suction port at or near a vessel wall for the more effective removal of thrombus resulting from directing the suction in the direction of the thrombus. In some embodiments, the tip portion of the catheter can be transitioned from a first configuration for delivery of the catheter into the vessel to a second more curved configuration with a desired design for application of suction. The catheter can be moved in a circumferential and/or lateral direction to cover selected portions of the inner vessel wall. In some embodiments, a partially occlusive structure can be used to reduce and/or redirect flow within the vessel to improve performance of the thrombectomy.

Claims

1. A thrombectomy catheter comprising a suction device, a proximal portion fluidly connected to the suction device, a tubular shaft attached at its proximal end to the proximal portion, and a tip portion at the distal end of the tubular shaft with a continuous suction lumen from the proximal portion to the tip portion wherein the tip portion comprises a suction port in fluid communication with the suction lumen, the tip portion having a first configuration and a second configuration that is curved relative to the first configuration.

2. The thrombectomy catheter of claim 1 wherein the suction device is a syringe.

3. The thrombectomy catheter of claim 1 wherein the tubular shaft has an outer diameter from about 0.26 mm to about 3.0 mm.

4. The thrombectomy catheter of claim 1 wherein the tubular shaft comprises a polymer selected from the group consisting of polyether-amide block co-polymer, nylon (polyamides), polyolefins, polytetrafluoroethylene, polyesters, polyurethanes, polycarbonates, mixtures thereof and copolymers thereof.

5. The thrombectomy catheter of claim 1 wherein the tip portion comprises a polymer selected form the group consisting of polyurethanes, polydimethyl siloxanes, polytetrafluoroethylene and mixtures thereof.

6. The thrombectomy catheter of claim 1 wherein the tip portion comprises one or more radiopaque markers.

7. The thrombectomy catheter of claim 1 further comprising an actuation device that can be actuated to transition the tip portion from the first configuration to the second configuration.

8. The thrombectomy catheter of claim 7 wherein the actuation device comprises a guide structure and the distal portion comprising a guide exit port and a distal guide lumen.

9. The thrombectomy catheter of claim 7 wherein the actuation device comprises an obturator and a wire connected to the obturator.

10. The thrombectomy catheter of claim 7 wherein the actuation device comprises a guide structure with a flexible distal section that is sufficiently flexible that the catheter transitions to the second configuration when the flexible distal section is appropriately aligned with the tip portion

11. The thrombectomy catheter of claim 1 further comprising a guide port to form a rapid exchange segment.

12. The thrombectomy catheter of claim 1 wherein the end of the tip portion tapers to a guide exit port.

13. A thrombectomy catheter comprising a suction device, a proximal portion fluidly connected to the suction device, a tubular shaft attached at its proximal end to the proximal portion, and a tip portion at the distal end of the tubular shaft with a continuous suction lumen from the proximal portion to the tip portion wherein the tip portion comprises a suction port in fluid communication with the suction lumen, the tip portion having a curve to present a displacement from the tip'"'"'s natural outer diameter of at least about 2 mm.

14. The thrombectomy catheter of claim 13 wherein the tip portion has one curve.

15. The thrombectomy catheter of claim 13 wherein the tip portion has at least two curves.

16. The thrombectomy catheter of claim 13 wherein the suction port is located along one of the curves.

17. The thrombectomy catheter of claim 13 wherein the suction port is located at the distal tip of the catheter.

18. The thrombectomy catheter of claim 13 further comprising a guide port to form a rapid exchange segment.

19. A thrombectomy catheter comprising a suction device, a proximal portion fluidly connected to the suction device, a tubular shaft attached at its proximal end to the proximal portion, and a tip portion at the distal end of the tubular shaft with a continuous suction lumen from the proximal portion to the tip portion wherein the tip portion comprises a suction port in fluid communication with the suction lumen, the tip portion having a curved structure that provides either at least three curves.

20. The thrombectomy catheter of claim 19 wherein the suction port is located along on of the curves.

21. The thrombectomy catheter of claim 19 wherein the end of the tip portion tapers to a guide exit port.

22. The thrombectomy catheter of claim 19 further comprising a guide port to form a rapid exchange segment.

23. A method for removing thrombus from a vessel of a patient, the method comprising aspirating fluid from the vessel through a suction port in a thrombectomy catheter having a tubular shaft that forms a majority of the length of the catheter and a tip portion comprising the suction port, the tip portion being connected at the distal end of the shaft with an aspiration lumen extending from a suction device to the aspiration port, wherein the tip portion is curved such that the tip portion has a displacement across the vessel at least as large as the vessel diameter such that a section of the tip portion contacts the vessel wall.

24. The method of claim 23 wherein the tip portion has a first configuration and a second configuration that is curved relative to the first configuration and the method further comprising transitioning the tip portion from the first configuration to the second configuration within the patient'"'"'s vessel.

25. The method of claim 24 wherein the thrombectomy catheter further comprises an actuation device that can be actuated to transition the tip portion from the first configuration to the second configuration.

26. The method of claim 25 wherein the actuation device comprises a guide structure and the distal portion comprises a guide exit port and a distal guide lumen and wherein the transitioning of the tip portion from the first configuration to the second configuration comprises withdrawing a guide structure past the distal guide lumen to release a curved section of the tip portion.

27. The method of claim 25 wherein the actuation device comprises an obturator and a wire connected to the obturator and wherein the transitioning of the tip portion from the first configuration to the second configuration comprises actuating the wire to move the obturator such that the obturator no longer restricts the tip portion from transitioning to the second configuration.

28. The method of claim 23 wherein the suction port is located at the distal end of the catheter.

29. The method of claim 23 wherein the tip portion has a plurality of curves and the suction port is located along one of the curves.

30. The method of claim 29 wherein the tip portion has at least 3 curves.

31. The method of claims 23 wherein the suction port is adjacent a vessel wall within a distance of the wall that is no more than about 10 percent of the vessel diameter.

32. The method of claim 23 wherein suction is applied while moving the catheter.

33. The method of claim 32 wherein moving the catheter comprises moving the catheter in a proximal direction.

34. The method of claim 32 wherein moving the catheter comprises moving the catheter in a circumferential direction.

35. The method of claim 23 further comprising partially occluding the vessel with a structure that extends beyond the natural outer diameter of the catheter.

36. A method for removing thrombus from a vessel of a patient, the method comprising aspirating fluid and/or debris from the vessel through a suction port in a thrombectomy catheter having a tubular shaft that forms a majority of the length of the catheter and a tip portion comprising the suction port, the tip portion being connected at the distal end of the shaft with an aspiration lumen extending from a suction device to the aspiration port, wherein the tip portion is curved to position the suction port adjacent a vessel wall within a distance of the vessel wall that is no more than about 10 percent of the vessel diameter.

37. A thrombectomy catheter comprising a suction device, a proximal portion fluidly connected to the suction device, a tubular shaft attached at its proximal end to the proximal portion, a tip portion at the distal end of the tubular shaft with a continuous suction lumen from the proximal portion to the tip portion, and a partially occluding structure comprising a flap that extends outward from other portions of the catheter or a balloon that extends only partially around the circumference of the catheter, wherein the tip portion comprises a suction port in fluid communication with the suction lumen.

38. The thrombectomy catheter of claim 37 wherein the catheter tip has a curve and the partially occluding structure is on the curve or distal to the curve.

39. The thrombectomy catheter of claim 37 wherein the partially occluding structure is a flat and the flap can be actuated with a pullwire.

40. A method for removing thrombus from a vessel of a patient, the method comprising aspirating fluid from the vessel through a suction port in a thrombectomy catheter having a tubular shaft that forms a majority of the length of the catheter and a tip portion comprising the suction port, the tip portion being connected at the distal end of the shaft with an aspiration lumen extending from a suction device to the aspiration port, wherein flow is partially occluded with a partial occlusion structure that extends from the outer diameter of the catheter.

41. The method of claim 40 wherein the partial occluding structure comprises a flap and the method further comprises actuating the flap from a low profile configuration to an extended partially occluding configuration.

42. The method of claim 40 wherein the partial occluding structure comprises a balloon structure.