EP1940500A2 - Sonde pour thrombectomie et autres sondes d'aspiration - Google Patents

Sonde pour thrombectomie et autres sondes d'aspiration

Info

Publication number
EP1940500A2
EP1940500A2 EP06813517A EP06813517A EP1940500A2 EP 1940500 A2 EP1940500 A2 EP 1940500A2 EP 06813517 A EP06813517 A EP 06813517A EP 06813517 A EP06813517 A EP 06813517A EP 1940500 A2 EP1940500 A2 EP 1940500A2
Authority
EP
European Patent Office
Prior art keywords
catheter
suction
tip portion
tip
port
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP06813517A
Other languages
German (de)
English (en)
Other versions
EP1940500A4 (fr
Inventor
Matthew F. Ogle
Mark W. I. Webster
Jason A. Galdonik
Gregory A. Boldenow
Edward Anderson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lumen Biomedical Inc
Original Assignee
Lumen Biomedical Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US11/207,169 external-priority patent/US8021351B2/en
Priority claimed from US11/206,680 external-priority patent/US7938820B2/en
Application filed by Lumen Biomedical Inc filed Critical Lumen Biomedical Inc
Publication of EP1940500A2 publication Critical patent/EP1940500A2/fr
Publication of EP1940500A4 publication Critical patent/EP1940500A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0041—Catheters; Hollow probes characterised by the form of the tubing pre-formed, e.g. specially adapted to fit with the anatomy of body channels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/008—Strength or flexibility characteristics of the catheter tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M2025/0034—Multi-lumen catheters with stationary elements characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0183—Rapid exchange or monorail catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1056—Balloon catheters with special features or adapted for special applications having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/0029—Multi-lumen catheters with stationary elements 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/0032—Multi-lumen catheters with stationary elements characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A61M25/0052—Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • the invention relates to a thrombectomy or vascular aspiration catheter having modifications that significantly facilitate the performance of a thrombectomy within a patient's vessel.
  • the invention further relates to procedures for performing a thombectomy using improved catheter designs.
  • the invention pertains to curved tip aspiration catheters that have improved tracking and that can be used for thrombectomy procedures or for the recovery of embolism protection devices.
  • An embolus can be any particle comprising a foreign and/or native material, which enters the vascular system or other vessel of the body with potential to cause occlusion of blood flow.
  • Emboli can be formed from aggregates of fibrin, blood cells or fragments thereof, collagen, cholesterol, plaque, fat, calcified plaque, bubbles, arterial tissue, and/or other miscellaneous fragments or combinations thereof. Emboli can lodge in the narrowing regions of medium or small sized blood vessels that feed the major organs. Loss of blood flow to surrounding tissue causes localized cell death or infarction. Cerebral infarcts can cause stroke leading to confusion, disturbance of speech, paralysis, visual disturbances, balance disturbances and even death.
  • thrombus has been used to refer specifically to clots generally comprising fibrin and/or platelets.
  • thrombus is used broadly to refer to any debris within a vessel that restricts or potentially restricts flow.
  • thrombus is used interchangeably with debris and with emboli.
  • Thrombus can result in undesirable restriction of flow within the vessel.
  • release of thrombus from a particular location can result in a more serious blockage of flow downstream from the initial release location.
  • Foreign material in the stream of flow can cause turbulence or reduced flow. Such flow conditions have been shown to increase rates of infection. Thrombus not only restricts flow, but also increases the risk of infection.
  • Percutaneous interventional procedures and surgical procedures for the treatment of renal artery stenosis can also generate emboli.
  • emboli There is clinical evidence to suggest that 36% of those treated suffer arterioloar nephrosclerosis caused by atheroemboli.
  • Five-year survival of patients with atheroembolic events is significantly worse than of patients without atheroemboli (54% vs. 85% respectively) [Krishmamurthi et al. J Urol. 1999, 161:1093-6].
  • Pulmonary embolism to the pulmonary arteries from deep veins of the legs is another major clinical problem, often with a large embolic load. Patients with the potential for pulmonary embolism may benefit from thrombus removal.
  • the invention pertains to 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.
  • a continuous suction lumen extends from the proximal portion to the tip portion.
  • the tip portion comprises a suction port in fluid communication with the suction lumen.
  • the tip portion has a first configuration and a second configuration that is curved relative to the first configuration.
  • the invention pertains to 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.
  • a continuous suction lumen extends from the proximal portion to the tip portion, and the tip portion comprises a suction port in fluid communication with the suction lumen.
  • the tip portion has a curve to present a displacement from the tip's natural outer diameter of at least about 2 or 3 mm.
  • the invention pertains to a method for removing thrombus from a vessel of a patient.
  • the method comprises aspirating fluid and particulate matter 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 is connected at the distal end of the shaft with an aspiration lumen extending from a suction device to the aspiration port.
  • the tip portion is curved to position the suction port adjacent to a vessel wall within a distance of the vessel wall that is no more than about 10 percent of the vessel diameter.
  • 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.
  • the invention pertains to 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.
  • the partially occluding structure can comprise a flap that extends outward from other portions of the catheter or a balloon that extends only partially around the circumference of the catheter.
  • the tip portion comprises a suction port in fluid communication with the suction lumen.
  • the invention pertains to a method for removing thrombus from a vessel of a patient.
  • the method comprises 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 is connected at the distal end of the shaft with an aspiration lumen extending from a suction device to the aspiration port.
  • Flow is partially occluded with a partial occlusion structure that extends from the outer diameter of the catheter.
  • the invention pertains to an aspiration catheter comprising a suction device, a proximal portion and a shaft with a proximal end and a distal end.
  • the shaft is operably connected at its proximal end to the proximal portion to form a suction lumen.
  • the suction device is attached or attachable to the proximal portion to operably connect the suction device to the suction lumen.
  • the shaft comprises a tip at the distal end having an aspiration opening. The tip has a curve relative to the general axis of the shaft.
  • the invention pertains to a method for the removal of an embolism protection device from a patient's vessel.
  • the method comprises applying suction while an aspiration catheter is being moved in a distal direction toward the embolism protection device in a deployed configuration.
  • the method further comprises collapsing an embolism protection device into a retrieval configuration while applying suction through the aspiration catheter.
  • the invention pertains to a method for the delivery of an aspiration catheter with a distal suction port.
  • the method comprises tracking a catheter along a guide structure with close tracking resulting from a curve in the catheter tip.
  • the catheter comprises a metal braid within a polymer to increase torque transmittal along the length of the catheter.
  • the invention pertains to a method for the performance of a procedure in a patient's vessel using a catheter having a bent tip and a suction port.
  • the catheter is a rapid exchange catheter comprising a guide port.
  • the method comprises delivering the catheter on a guide structure into the vessel and applying suction to remove debris from the vessel.
  • the guide structure extends through the guide port.
  • the invention pertains to a rapid exchange catheter system comprising a catheter and a loading tool.
  • the catheter comprises a suction device, a proximal portion operably connected to the suction device and a shaft attached to the proximal portion.
  • the shaft comprises a guide port toward the distal end of the shaft, and the loading tool comprises a rod and a distal cavity that can engage a guide structure.
  • the loading tool has dimensions suitable for advancement of the rod through the port.
  • the invention pertains to a method for loading a rapid exchange catheter in which the method comprises engaging a guide structure with a loading tool that directs the guide structure through a rapid exchange port as the loading tool is removed through the rapid exchange port.
  • Fig. 1 is a side view of a rapid exchange aspiration catheter with a curved tip.
  • Fig. 2 is a fragmentary view of the curved tip of the aspiration catheter of Fig. 1 interfacing with a guide structure.
  • Fig. 3A is a side view of a specific embodiment of a rapid exchange aspiration catheter with a curved tip.
  • Fig 3B is an expanded fragmentary view of the curved tip of the aspiration catheter of Fig. 3 A.
  • Fig. 4A is a top view of an alternative specific embodiment of a rapid exchange catheter with a curved tip, which is not visible in the top view.
  • Fig. 4B is an expanded fragmentary side view of the rapid exchange tip section of the catheter of Fig. 4A.
  • Fig. 4C is an expanded fragmentary bottom view of the guide port of the aspiration catheter of Fig. 4 A.
  • Fig. 5 is a fragmentary side view of a thrombectomy catheter with a curved tip portion.
  • Fig. 6 is a fragmentary side view of the distal end of a thrombectomy catheter with a rapid exchange segment.
  • Fig. 7A is a fragmentary side view of the distal end of a thrombectomy catheter with a suction port at its distal end.
  • Fig. 7B is a fragmentary side view of a distal end of a thrombectomy catheter with a suction port at its distal end having an angled opening relative to its lumen.
  • Fig. 8 A is a fragmentary side view of a rapid exchange thrombectomy catheter with a suction port at its distal end and an angled opening.
  • Fig. 8B is a fragmentary side view of the rapid exchange aspiration catheter of Fig. 8 A shown with the guide structure separated from the aspiration catheter.
  • Fig. 8 C is a fragmentary side view of the distal end of the rapid exchange catheter of Fig. 8A shown with a loading tool facilitating the loading of the guide structure within the rapid exchange port.
  • Fig. 8D is a side view of an alternative embodiment of a loading tool.
  • Fig. 8E is a fragmentary side view of the distal end of the rapid exchange catheter of Fig. 8A shown with the loading tool of Fig. 8D.
  • Fig. 8F is a sectional view of the catheter and loading tool of Fig. 8E taken along line F-F of Fig. 8E.
  • Fig. 9 is a fragmentary side view of a distal end of a curved tip of a thrombectomy catheter with displacement distance "D" marked appropriately.
  • Fig. 1OA is a fragmentary side view of an embodiment of the distal end of a thrombectomy catheter with a distal guide lumen and a guide structure extended through the distal guide lumen to hold the tip in a delivery configuration.
  • Fig. 1OB is a fragmentary side view of the distal end of a rapid exchange embodiment of a thrombectomy catheter with a distal guide lumen.
  • Fig. 1OC is a fragmentary side view of the distal end of a thrombectomy catheter with a distal guide lumen that also functions as a rapid exchange segment.
  • Fig. 1 IA is a fragmentary side view of the thrombectomy catheter of Fig. 10 with the tip in a curved configuration with the distal guide lumen free of the guide structure.
  • Fig. 1 IB is a fragmentary side view of the thrombectomy catheter of Fig. 10 with a guide structure having blades suitable to free the guide structure from the distal lumen.
  • the insert shows an expanded view of the guide structure in the vicinity of the blades.
  • Fig. 12 is a fragmentary side view of the thrombectomy catheter of Fig. 10 with the tip in a curved configuration due to the guide structure being positioned with a flexible portion at the catheter tip.
  • Fig. 13A is a side view of an alternative embodiment of a thrombectomy catheter with an obturator maintaining the tip in a delivery configuration.
  • Fig. 13B is a side view of the thrombectomy catheter of Fig. 13A with the obturator withdrawn such that the tip is in a curved configuration.
  • Fig. 14A is a side view of a thrombectomy catheter with an extended obturator within the lumen of the catheter.
  • Fig. 14B is a side view of the thrombectomy catheter of Fig. 14A with a curved tip floowing removal of the obturator and guide structure.
  • Fig. 14C is a side view of an alternative embodiment of the obturator of Fig. 14A with a rapid exchange design.
  • Fig. 14D is a side view of another alternative embodiment with the use of an obturator of Fig. 14A with a catheter adapted for use with a guidewire extending through a slit when the catheter tip is bent.
  • Fig. 14E is a side view of the catheter of Fig. 14D with the obturator removed such that the tip is in its curved configuration.
  • Fig. 15 A is a fragmentary, side view of an alternative embodiment of a thrombectomy catheter with a side aspiration hole and with an obturator configuring the catheter for delivery.
  • Fig. 15B is a fragmentary side view of the thrombectomy catheter of Fig. 15A with the obturator removed such that the catheter has a curved configuration.
  • Fig. 16A is a side view of a thrombectomy catheter with a curved tip that is held in a delivery configuration by a guide structure.
  • Fig. 16B is a side view of the thrombectomy catheter of Fig. 16A in which the guide structure is moved in a proximal direction to position a more flexible portion of the guide structure at the curve of the catheter such that the catheter takes it curved configuration.
  • Fig. 17 is a side view of another alternative embodiment of a thrombectomy catheter with three curves of the tip and a side suction port.
  • Fig. 18A is a side view of a specific embodiment of a thrombectomy catheter with three curves.
  • Fig. 18B is a side view of an embodiment of a thrombectomy catheter with a curved shape and a slit to provide for curving of the catheter without interference or with reduced interference of the curvature due to a guide structure associated with the catheter.
  • Fig. 18C is a side view of an embodiment of a thrombectomy catheter with a curved shape and with two guide ports to provide for curving of the catheter without interference or with reduced interference of the curvature due to a guide structure associated with the catheter.
  • Fig. 18D is a side view of an embodiment of a thrombectomy catheter with an aspiration port at the distal end of a curved tip and with a distal guide port and a rapid exchange port.
  • Fig. 18E is a side view of an embodiment of a thrombectomy catheter with a curved suction extension and an aspiration port along the side of the extension.
  • Fig. 18F is a side view of an embodiment with a flexible expandable tip.
  • Fig. 20 is a side perspective view of a thrombectomy catheter with a partly occluding balloon element around a portion of the catheter circumference along a curve of the catheter.
  • Fig. 21 is a side perspective view of a thrombectomy catheter with a partly occluding flap shown in a non-deployed configuration.
  • Fig. 22 is a side perspective view of a thrombectomy catheter with a braid structure around the circumference of the catheter for partial occlusion of a vessel.
  • Fig. 23 is a fragmentary side view of a tip portion of a thrombectomy catheter having a stiffer material around a suction port relative to an adjacent more flexible material with several radiopaque markers also shown.
  • Fig. 24 is a schematic, fragmentary side view of a curved catheter tip portion in an unrestrained view (left side) and a deflected, strained configuration within a vessel (right view).
  • Fig. 25 is a schematic view of a patient's vessel with a guide structure passing by a lesion with thrombus.
  • Fig. 26 is a schematic side view of the vessel of Fig. 25 with a thrombectomy catheter being positioned within the vessel.
  • Fig. 27 is a schematic side view of the vessel of Fig. 25 with a thrombectomy catheter in position and its tip being released form a delivery configuration to a curved configuration.
  • Fig. 28 is a schematic side view of the vessel of Fig. 25 with a thrombectomy catheter of Fig. 21 m a. curved configuration.
  • Fig. 29 is a schematic side view of the vessel of Fig. 25 with the thrombectomy catheter of Fig. 28 removing thrombus from the vessel.
  • Fig. 30 is a schematic side view of the vessel of Fig. 25 with a stent being delivered following removal of the thrombus with a thrombectomy catheter.
  • Fig. 32 is a schematic view of a thrombectomy catheter removing thrombus from within a coronary artery.
  • Fig. 33 is a schematic view of a thrombectomy catheter removing thrombus from within a carotid artery.
  • Fig. 34 is a side view of an aspiration catheter positioned within a patient's vessel adjacent a deployed embolism protection device.
  • Fig. 35 is a side view of the aspiration catheter of Fig. 34 with suction being applied.
  • Fig. 36 is a side view of the aspiration catheter of Fig. 34 with suction being applied and with the embolism protection device converted to a recovery configuration.
  • Fig. 37 is side view of the aspiration catheter of Fig. 34 with the embolism protection device within the aspiration catheter.
  • An improved thombectomy catheter has a curve in the catheter near its distal end and a suction port at or near the distal end of the catheter in an appropriate configuration such that the suction port can be located at or near the wall of a vessel upon deployment within a patient's vessel.
  • the suction port can be swept around the inner circumference of the vessel to remove effectively thrombus from various locations within the vessel, and similarly lateral motion can be used to sweep the length of the vessel to remove thrombus.
  • Several types of curved structures can be provided for the catheter tip while providing a desired configuration for the suction port.
  • the catheter tip can be bent to a straighter configuration for delivery to the selected location within a vessel.
  • the ability to position an aspiration port at or near a vessel wall provides for significantly improved ability to remove thrombus attached to the wall since the aspiration is directed to the thrombus where the suction can be more effective than directing the suction generally in the vicinity of the thrombus.
  • the tip can be flexible enough for efficient delivery while having a sufficiently fixed configuration such that the side port can be maintained at or near the vessel wall near where the thrombus is attached.
  • the design of the aspiration catheter can provide for withdrawal of an embolism protection device into the catheter for retrieval of the embolism protection device while providing improved tracking during delivery.
  • the present devices and corresponding processes are intended for the direct removal of thrombus from a patient's vessel using suction.
  • the thrombectomy catheters described herein can be used alone or in association with other treatment approaches.
  • suitable deposits of thrombus can be directly removed as an alternative or in preparation for the delivery of a stent and/or other treatments.
  • Visualization techniques can be used to position the catheter at the desired location.
  • thrombus removal can be more effective without the need for mechanical or other abrasion to loosen the thrombus and with less disruption of the natural flow through the vessel.
  • the flow can be partially occluded to increase the effectiveness of the suction. If the aspiration catheter has a distal suction opening, the aspiration catheter can be used to recover an embolism protection device.
  • the aspiration can be applied prior to or after the use of other treatment devices.
  • the thrombectomy catheter can be used prior to the application of the other treatment approach to remove dispersed sections of thrombus to better localize the thrombus prior to use of the other treatment approach.
  • the thrombectomy catheter can be used after application of another treatment approach to remove residual thrombus that was not adequately treated using the initial approach. In either application, the ability to predictably place the suction port at or near the wall of the vessel improves the performance of the procedure and the control of the ultimate results.
  • Medical systems incorporating the thrombectomy catheter can make use of general devices and methods for the performance of less invasive percutaneous procedures.
  • guide catheters, hemostatic valves and other devices to facilitate catheter use can be adapted for use with the present catheter systems.
  • the specific instrumentalities for use with the thrombectomy catheters include, for example, a guide structure, an optional filter and optional additional treatment structures.
  • Suitable guide structures include, for example, guidewires and integrated guide devices that have a corewire and an overtube, as described further below.
  • Optional filters can comprise fibers that form a three-dimensional filtration matrix and can be adapted for deployment using an integrated guiding device.
  • Optional additional treatment structures include, for example, angioplasty balloons, stents, and abrasion-based thrombectomy structures.
  • the thrombectomy catheters described herein are aspiration catheters adapted to more effectively aspirate adjacent a vessel wall.
  • the thrombectomy catheters can have an over-the-wire design or a rapid exchange design.
  • the catheter In an over-the-wire design, the catheter is designed such that the guide structure traverses from a point near the proximal end of the catheter to a point near the distal end of the catheter within the catheter.
  • a rapid exchange design the guide structure lies outside of the catheter except for a rapid exchange segment near or at the distal end of the catheter.
  • the guide structure extends within at least a portion of the rapid exchange segment. Functional features relating to the delivery of suction and the orientation and structure of the distal tip of the catheter are generally independent of the over-the-wire versus rapid exchange structure, although some minor design considerations may be influenced by the rapid
  • the thrombectomy catheters comprise a suction device, a proximal portion 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.
  • a continuous suction lumen is formed between the proximal portion and the tip portion.
  • the continuous lumen provides for the transmission of suction from the suction device, such as a syringe, at the proximal portion to a port located in the tip portion.
  • the suction port can be located at the distal end of the catheter or at a location displaced from the distal end such that the port can be referred to as a side port.
  • the tip portion can have a plurality of suction ports. Regardless of the location of the suction port, the distal portion has a configuration that generally positions the port at or near the wall of the vessel for the application of suction at the vessel wall for appropriately sized vessels.
  • the distal portion has a curved configuration to present a displacement across the vessel diameter comparable to or greater than the vessel diameter to constrain the port at or near the vessel wall generally through contact with the vessel walls at multiple points. The curve can result in a displacement of the catheter tip greater than the diameter of most vessels in which the catheter is used such that the suction port is generally adjacent to the wall of the vessel during use.
  • a single catheter can be used for a range of vessel sizes while having a suction port appropriately positioned at or near the vessel wall.
  • the catheter tip portion has two configurations.
  • a first configuration is designed to facilitate delivery of the catheter at the desired site with less opportunity for interacting with features within the vessel during delivery.
  • this delivery configuration generally has a straighter orientation with respect to an axis that runs along the tubular shaft of the device.
  • a second configuration has a more curved orientation. In the more curved orientation, the port is displaced such that it is constrained to be close to the wall of the vessel for appropriately sized vessels.
  • the release of the tip from the first orientation to the second curved orientation can be performed through the relative positioning of the catheter with respect to the guide structure or with a separate actuation element.
  • the second orientation can be the natural position of the tip such that the first straighter orientation involves straining the tip to the straighter configuration.
  • the straighter configuration is maintained until released such that it can transition to the second more bent configuration.
  • the tip portion has a curve that inherently positions the port at or near the vessel wall once the catheter is placed at the selected location.
  • the tip portion can have a plurality of curves that contour the tip to yield desired results.
  • the tip portion has a configuration such that one edge of the tip portion is positioned near the vessel wall to constrain another portion of the tip portion to be near the opposite side of the vessel wall.
  • a suction port can be place near one or both of these portions that are located near or at the vessel wall. While suitable configurations can be achieved with a single curve at the tip, a plurality of curves can result in desirable contours that can be directed conveniently to the target site.
  • the device has a plurality of curves and a side port.
  • the distal tip of the thrombectomy catheter is made from a material that is more flexible than the shaft of the catheter.
  • the shaft generally is flexible enough to negotiate through the patient's vessels but stiff enough for control of the movement of the catheter from the proximal end.
  • the distal tip portion or section thereof can be more flexible to provide for improved steering of the catheter as the catheter is being negotiated through a patient's vasculature or other vessels.
  • the flexibility of the tip can also be beneficial with respect to contacting the vessel walls without inducing damage to the walls since the tip should be flexible enough that the vessel wall is not damaged from the contact with the walls .
  • Embolism protection devices generally filter fluid flowing within the vessel to capture emboli within the flow. Embolism protection devices can be delivered in response to a variety of circumstances.
  • the device can be delivered prior to performance of a medical procedure that has the potential of resulting in the release of emboli.
  • one or more devices can be implanted following an injury or trauma that can result in the formation and/or release of emboli.
  • one or more devices can be implanted in an individual that had developed a physiological condition in which emboli may develop.
  • the devices can be used in conjunction with other therapeutic device(s) and/or therapy such, as drug therapy.
  • Embolism protection devices of particular interest have three dimensional filtering matrices, as described further below, although other devices may substantially or completely block flow, such as a balloon based embolism protection device. Specific embodiments of embolism protection devices are described in copending U.S.
  • Patent Application serial number 10/414,909 to Ogle entitled “Embolism Protection Device,” incorporated herein by reference, in copending U.S. Patent Application serial number 10/795, 131 filed March 6, 2004 to Galdonik et al, entitled “Fiber Based Embolism Protection Device,” incorporated herein by reference and in copending U.S. Application serial number 11/072,001 to Galdonik et al., entitled “Steerable Device Having A Corewire Within A Tube And Combination With A Functional Medical Component,” incorporated herein by reference. Regardless of the circumstances in which the device is implanted, many embodiments subsequently have indications calling for the subsequent removal, i.e., recovery, of the device.
  • the embolism protection device is removed from the flow generally after the causes of an embolic event are no longer present.
  • the removal of the device from the patient can disrupt the device in a way that can result in release of some of the emboli from the device. Any released emboli can flow down stream and pose a risk to the patient.
  • Recovery can be performed, for example, after conclusion of a specific medical procedure, after a particular risk has passed or in conjunction with the placement of another replacement embolism protection device.
  • Manipulating the embolism protection device can create a risk associated with dislodging emboli entrapped in the device and release of the emboli into the patient's fluid flow, whether blood or other fluid.
  • the devices and procedures described herein facilitate the removal of an embolism protection device with reduced or eliminated loss of trapped emboli during the removal of the device.
  • the devices and procedures can be used with respect to embolism protection devices that are not attached after delivery or embolism protection devices that remain attached after delivery.
  • the aspiration catheters can be used for the retrieval of a range of embolism protection devices.
  • embolism protection devices of particular interest comprise a three-dimensional filtering matrix.
  • the embolism protection device is formed as an integral component of an integrated guiding structure for tethered placement within a vessel during a procedure and subsequent removal.
  • the three-dimensional filtration matrix of the embolism protection devices provide for improved emboli capture with reduced or eliminated restriction of natural flow during deployment, and the aspiration catheters described herein provide for improved retrieval of the embolism protection devices with reduced or eliminated risk of releasing emboli downstream during the recovery process.
  • the thrombectomy catheter can comprise a structure to induce a partial occlusion of the vessel beyond the constraints induced by the presence of the catheter shaft.
  • the suction from the thrombectomy catheter to some degree works against the natural flow within the vessel. Avoiding total occlusion of the vessel reduces the risk to the patient that can result from the stopped flow. Also, having some flow can help to irrigate the site to provide more complete removal of thrombus. However, the full flow in the vessel can require excessive suction through the catheter and can flow dislodged thrombus from the site before suction can remove the thrombus into the catheter.
  • partial occlusion of the vessel can be desirable.
  • the catheter is positioned near the thrombus, generally using a suitable less invasive delivery procedure, although a surgical procedure can be used to expose the vessel.
  • a surgical procedure can be used to expose the vessel.
  • generally heart procedures involve an incision in the groin or wrist to access an artery that leads to the heart.
  • Suitable visualization approaches can be used to position the tip of the catheter.
  • the thrombus can be located prior to and/or during the thrombectomy procedure.
  • the catheter tip is curved, if it is not delivered in a curved configuration.
  • suction may or may not be applied during the introduction of the catheter into the vessel and during tracking to the target position. Further, suction may or may not be applied as the tip is moved to its curved configuration.
  • the suction port is positioned at or near the vessel wall.
  • the aspiration catheter can generally be moved to sweep the suction port along the inside of the vessel wall.
  • the catheter tip can be moved circumferentially and/or laterally along the vessel wall. The lateral movement can be in a distal and/or a proximal direction. The extent of the motion of the catheter tip can be selected based on an evaluation of the thrombus within the vessel.
  • the guide structure can comprise an embolism protection device to capture any thrombus that escapes aspiration to become emboli moving within the vessel.
  • Suitable embolism protection devices include, for example, embolism protection devices formed from fibers that are expanded across the vessel lumen to collect emboli.
  • An integrated guiding structure, with a corewire and overtube, can be used as the guiding apparatus for the catheter such that the integrated guiding structure can be used to deploy and recover the embolism protection device.
  • a separate aspiration, recovery catheter can be used to facilitate recovery of the embolism protection device.
  • the thrombectomy catheter can be used in combination with other tteatment structures.
  • the thrombectomy catheter can be used to remove portions of thrombus prior to the performance of an angioplasty procedure and/or the delivery of a stent.
  • the prior removal of selected thrombus can improve the indications and expected results for the angioplasty/stent delivery.
  • the thrombectomy catheter can be used, for example, following an angioplasty/stent delivery, for example, to remove thrombus that has been loosened and/or residual thrombus following the initial procedure.
  • the thrombectomy catheter can be used to apply suction along the interior of a stent following delivery of the stent.
  • the improved thrombectomy catheter can be used prior to, at the same time or after the use of another thrombectomy instrumentality.
  • Some thrombectomy instrumentalities deliver abrasive forces to vessel wall to dislodge thrombus.
  • these apparatuses can deliver cutting surfaces to the vessel wall to dislodge and/or fragment thrombus.
  • the aspiration catheter For retrieval o f an embolism protection device, the aspiration catheter generally is positioned relatively close to the deployed device.
  • a guide component of the catheter is transitioned to a retrieval position such that the embolism protection device can enter into the opening of the aspiration catheter. This transition can be performed prior to the beginning as aspiration, although it can also be performed while aspiration is being applied or at a break in application of aspiration.
  • suction can be applied as the embolism protection device is transformed from a deployed configuration to a configuration with a narrower profile for withdrawal.
  • the embolism protection device can be transformed from the deployed configuration with an actuator, such as a hypotube - corewire integrated system, that directly converts the device from the deployed configuration to a recovery configuration.
  • the embolism protection device can be mechanically compressed into a recovery configuration. In the recovery configuration, the device does not extend across the cross section of the vessel lumen such that it can be withdrawn from the vessel, generally along a guidewire and/or catheter.
  • the improved thrombectomy catheter designs described herein provide considerable flexibility to a treating physician with respect to the removal of thrombus that is at least partially blocking flow within a patient's vessel.
  • the thrombectomy catheter has a single lumen from the hub to the tip to provide a larger inner cross section for the aspiration lumen. The ability to directly remove thrombus using aspiration adds another dimension to the selection of effective treatment approaches for serious medical conditions.
  • the thrombectomy catheters of particular interest have a distal tip with a configuration having a curve that displaces a suction port such that the port would be positioned at or near a vessel wall when placed in a suitable vessel.
  • Various curved structures can provide for suitable placement of the suction port, with several embodiments described below.
  • the thrombectomy catheter can be designed to perform a treatment procedure, i.e., thrombus removal, within any vessel of a patient, such as a urinary tract vessel, a reproductive tract vessel, or a vascular vessel.
  • a treatment procedure i.e., thrombus removal
  • improved tracking for aspiration catheters during delivery into a patient's vessel can be achieved through selection of materials to provide a more flexible structure at or near the distal end of the catheter, or alternatively or additionally through selection of an improved design of the catheter tip or of structures associated with the catheter tip.
  • a more flexible tip more faithfully tracks along a guide structure and more easily deflects rather than snagging on structure within a vessel.
  • Improved tip designs can be based on a curving of the tip that provides for improved tracking especially at bends or braches in the vessel as well as a reduced likelihood of getting snagged.
  • Aspiration catheter 50 comprises a proximal section 52, a shaft 54, a rapid exchange segment 56 and a guide port 58 at the interface of the shaft and the rapid exchange segment.
  • Rapid exchange segment 56 has a curved tip 60.
  • the angle of the curved tip relative to a straight tip generally is less than 90 degrees and can be, for example, from about 10 degrees to about 60 degrees. The selected angle corresponds with a radius of curvature.
  • the straight portion of the tip after the curve can have a length less than about 1 cm, and in other embodiments from about 0.1 mm to about 6 mm and in further embodiments from about 0.5 mm to about 4 mm.
  • the curve consists of a gradual arc with no straight section distal to it.
  • the curved tip can be formed using any suitable approach, such as molding the curved tip in the desired configuration or heating the material on a curved mandrel or in a curved trough to a softening temperature and then cooling the material on the mandrel/in the trough to fix the shape.
  • Edge 62 of curved tip at the opening of the catheter can be cut straight perpendicular to the axis of the tip at the opening or at an angle relative to a straight cut. In some embodiments, edge 62 can have a non-planar contour.
  • the guide structure During the delivery of catheter 50 over a guide structure, the guide structure generally extends through port 58 and out the opening of the catheter at edge 62.
  • the guide structure When aspiration catheter 50 is being advanced along a guide structure, the guide structure generally has a position extending through the patient's vessels that follows various curves and/or branches.
  • the guide structure extending from the curved tip introduces tension on the curved tip that tends to counter elastic forces in the curved tip to follow the natural curved configuration.
  • the curved tip is distorted by the guide structure if the tension in the guide structure exceeds the tension in the tip. This tension in curved tip 60 on the guide structure 64 tends to force the tip into a particular configuration as shown schematically in Fig. 2.
  • the tip opening presents a small profile for snagging and tracks closely along the path of the guide structure as it is pushed along the guide structure. Also, the curved tip deflects the sharp edge of the tip away from the vessel wall and naturally tracks along the guide structure with little drifting since the curve creates a tight transition from the wire to the catheter on one side of the curve.
  • Catheter 70 is designed for delivery into coronary arteries, although adjustments in the sizing and configuration can be made by a person of ordinary skill in the art for use in other locations in a patient based on this design.
  • Catheter 70 has four segments, female Luer connection 72, first shaft segment 74, second shaft segment 76 and rapid exchange segment 78.
  • the overall length of catheter 70 is about 150 centimeters (cm).
  • Female Luer connector 72 generally is a molded hub formed from a suitable material, such as polycarbonate, that can be joined to first shaft segment 74.
  • first shaft segment 74 can be formed from nylon, such as nylon 11, with an embedded stainless steel braided flat wire with dimensions 0.001 inches by 0.002 inches.
  • First shaft segment 74 has a length of about 120 cm.
  • Two colored polymer bands 90, 92 are placed about 45 cm and 55 cm, respectively, from the proximal end, i.e., the Luer connector end, of the catheter.
  • Second shaft segment 76 can be formed from a nylon polymer without metal reinforcement. Suitable nylons are commercially available from various suppliers with good resistance to stress cracking and good tensile and flexural strength. Second shaft segment 76 can have a length of 24.5 cm. Both first shaft segment 74 and second shaft segment 76 can have an outer diameter of about 0.053 inches, although other sizes can be selected for particular applications. The size can be selected to provide an inner diameter suitable for a desired amount of suction. Second shaft segment 76 provides added flexibility toward the distal end of the catheter.
  • Rapid exchange segment 78 has a total length of about 7.5 cm. Rapid exchange segment 78 can be formed from a nylon polymer with a stainless steel coil or braid embedded in the polymer. A suitable stainless steel has a coiled length of 6 cm, a pitch of 0.010 inches and fiat wire dimensions of 0.001 inches by 0.005 inches.
  • Fig. 3B shows an expanded view of rapid exchange segment 78 and its connection with second shaft segment 76. Port 94 is formed at the connection between rapid exchange segment 78 and second shaft segment 76. Port 94 has a diameter of about 0.0145 inches. Platinum- iridium radiopaque marker band 96 is located near the tip of rapid exchange segment 78. Opening 98 is cut at an angle from the perpendicular relative to the central axis of the lumen with the inner curve about 0.030 inches shorter than the outer curve.
  • aspiration catheter 71 comprises a female Luer lock connector 73, shaft 75, and rapid exchange segment 77.
  • Shaft 75 has braided wire along its entire length.
  • Two colored bands 79, 81 are located along shaft 75 to provide information on the position of the catheter to the operator.
  • Rapid exchange segment 77 has a total length of about 20 cm and also has braided wire which can cover its entire length or there can be a small gap of a few millimeters or less adjacent shaft 75. In some embodiments, rapid exchange segment 77 has an approximately equal or just slightly smaller diameter as shaft 75.
  • rapid exchange segment 77 has an approximately equal or just slightly larger diameter as shaft 75 Rapid exchange segment 77 has a curved tip 83 as shown in Fig. 4B.
  • the distal 1.5 centimeters of the tip, including the curve, are made form a particularly soft material.
  • a radiopaque marker 85 can be placed near the tip.
  • guide port 87 can be formed by deforming a trough 89 into the distal edge of the shaft where it meets the rapid exchange segment.
  • the outer diameter of the shaft may range form about 0.05 inches to about 0.07 inches and the thickness can be roughly 0.01 inches.
  • a thrombectomy catheter 100 generally comprises a suction device 102, a proximal portion 104, a tubular shaft 106 and a distal tip portion 108.
  • Thrombectomy catheter 100 further comprises radiopaque markers 110, 112. Marker 110 is at the distal end of the catheter, and marker 112 is located near suction port 114. Radiopaque materials for visualization are described further below. If the suction port is located at the distal tip, one marker can be used to identify this location. Additional or alternative marker placements can be used for visualization as desired.
  • appropriate features of Fig. 5 can be combined with the embodiments of Figs. 1-4.
  • Suitable suction devices 102 include, for example, suction device that draws a desired suction with respect to volumes in a selected period of time, such as a syringe, a pump, such as a peristaltic pump or a piston pump, a compressed bladder or the like.
  • Proximal portion 104 generally is operably connected to suction device 102 and to the proximal end of tubular shaft 106.
  • Proximal portion 104 can comprise a handle, ports or other convenient control structures for manipulating thrombectomy catheter 100 and/or the interface of thrombectomy catheter 100 and other intervention devices.
  • Proximal portion 104 generally comprises an aspiration connection 120 that provides for connection of proximal portion 104 with suction device 102.
  • Aspiration connection 120 can be placed at the proximal end or other location near the proximal end, as convenient.
  • aspiration connection 120 can comprise a fitting 122 or the like to provide a sealed connection with suction device 102.
  • Suitable fittings include, for example, a conventional fitting, such as an elastomeric diaphragm through which a syringe needle can be inserted or a Luer lock.
  • Suction device 102 can be connected to aspiration connection 120, optionally with a portion of tubing or the like in some embodiments.
  • Tubular shaft 106 generally is connected at its proximal end to proximal portion 104.
  • Tubular shaft 106 has an interior lumen that can transmit suction from the section device through the interior lumen. A portion of the suction lumen can pass through proximal portion 104.
  • tubular shaft 106 Suitable ranges of dimensions of tubular shaft 106 generally depend on the particular use of the device. Three particular uses of interest include, for example, removal of thrombus from medium-sized blood vessels, such as coronary arteries to the heart, cerebral vessel to the head or distal leg vessels; removal of thrombus from larger vessels, such as the carotid, renal or iliofemoral vessels; or removal of thrombus from the pulmonary arteries to the lungs and from its branches.
  • Tubular shaft 106 can have an approximately constant diameter, a varying diameter and/or sections with different diameters.
  • the average outer diameter of tubular shaft 106 ranges from about 0.010 inches (0.26 mm) to about 0.115 inches (3.0 mm), in further embodiments from about 0.020 inches (0.5 mm) to about 0.080 inches (2.1 mm) and in additional embodiment from about 0.030 inches (0.78 mm) to about 0.055 inches (1.4 mm).
  • the outer diameter may or may not be constant over the length of shaft 106.
  • shaft 142 For intervention into blood vessels near the heart, shaft 142 generally has a length in some embodiments from about 75 cm to about 200 cm, in additional embodiments from about 85 cm to about 180 cm, and in further embodiments from about 100 cm to about 170 cm.
  • the thrombectomy catheter generally can have a length less than 75 cm (29.5 inches), in further embodiments from 5 cm (2.0 inches) to 50 cm (19.7 inches) and in other embodiments from about 8 cm (3.1 inches) to about 40 cm (15.7 inches).
  • a person of ordinary skill in the art will recognize that for each of the embodiments additional ranges of dimensions of the thrombectomy catheter within the explicit ranges above are contemplated and are within the present disclosure.
  • Two general forms of the thrombectomy catheter include, for example, an over- the-wire design or a rapid exchange design.
  • the rapid exchange design has a port through which a guidewire/guide structure can enter into the catheter while in an over- the-wire design the guide structure travels within the catheter along the majority of the length or the entire length of the catheter within the patient. It may be somewhat arbitrary in some embodiments to specify the point at which the tip portion starts and the shaft end, but certain structure is associated with the tip portion. Also, the tip or a portion thereof is generally formed from different materials than the shaft, and this change in composition can be used to demarcate the tip from the shaft. With either an over-the- wire design or a rapid exchange design, the guide structure can travel through the suction lumen or through a separate lumen.
  • a catheter with a rapid exchange design has a rapid exchange segment that comprises the distal tip portion.
  • catheter 130 has rapid exchange segment 132 and a guide port 134 through which guide structure 136 can pass.
  • a standard guidewire for vascular applications has a diameter of about 0.014 inches, such that a suitable port would be slightly larger, such as 0.0145 inches, to provide for passage of the guide structure.
  • Distal tip portion 138 comprises a side suction port 140.
  • the positioning of the guide port can be selected at least in part based on the curve of the tip and the position of the suction port. For example, if the catheter has a side suction port, the guide port can be located along the opposite side of the tubular structure, as shown in Fig.
  • a tube or other loading tool can be preloaded through guide port 134 to facilitate loading of the guide structure into the guide port from the distal opening when the guide structure is placed within the patient.
  • the loading tube or loading tool can be removed once the guide structure is guided through guide port 134.
  • Many of the designs below can be adapted for a rapid exchange configuration through the inclusion of a suitable guide port.
  • the tip of the catheter can be tapered to have a guide exit port effectively at the distal end of the catheter.
  • guide exit port 150 is located at the distal end of distal tip portion 108.
  • guide exit port 152 is located at the distal end of rapid exchange segment 132.
  • the tapering of the catheter end with the exit port effectively blocks suction through the end of the tip portion since the guide structure blocks the exit port such that suction effectively is directed only to the suction port.
  • multiple suction ports can be used, such as two side ports or a side port and a distal end port.
  • the suction port is located at the end of the distal tip portion. Referring to Fig. 7 A, distal tip portion 160 extends from shaft 106. Distal tip portion 160 has a suction port 162 at its distal end.
  • a rapid exchange segment can similarly have a suction port at its distal end.
  • the guide structure generally extends out from the catheter at the distal end, although it extends traverse along the length of the catheter shaft within the aspiration lumen or through a separate guide lumen.
  • distal tip portion 160 has a curve 164 that tends to position suction port 164 at the vessel wall when the catheter is within a patient's vessel.
  • the end of distal tip portion has an orientation that is essentially perpendicular to the axis of the lumen.
  • distal tip portion 166 has a suction port 168 at the end of distal tip portion 166 that is at an angle to the axis of the lumen. The angle can orient the port more level along the wall of the vessel to facilitate the application of suction along the wall.
  • Thrombectomy catheter 170 has suction port 172 with an angled opening at its distal end and a guide port 174.
  • guide structure 176 extends through guide port 174 and out through suction port 172.
  • Distal tip 178 of thrombectomy catheter 170 has a natural curved shape as seen in Fig. 8B. Referring to Fig. 8A, flexibility of distal tip 178 tends to conform distal tip 178 to the path of the guide structure 176.
  • guide structure 176 can be withdrawn through guide port 174. Guide structure can be returned to its original position for subsequent use, as shown in Fig. 8B, or guide structure 176 can be withdrawn from the patient.
  • a loading tool 180 can be used to facilitate the placement of guide structure 176 through guide port 174.
  • Loading tool 180 comprises a rod 182 and a tube 184, such as a polymer tube. The end of guide structure 176 can be held within tube 184 and pulled through guide port 174. Loading tool 180 can be removed after the guide structure is loaded.
  • An alternative embodiment of a loading tool is shown in Fig. 8D.
  • Loading tool 186 fits within the suction port 172.
  • Loading tool 186 has a generally cylindrical shape with a channel 188 extending along one side. With the loading tool within suction port 172, channel 186 can direct guide structure 176 to guide port 174, as shown Fig. 8E.
  • a sectional view of the guide structure within channel 186 is shown in Fig. 8F.
  • the curved distal tip portion generally is configured to direct the suction port at or near the vessel wall. Generally, this positioning is accomplished through having a sufficient bend in the catheter tip that the suction port and another portion of the catheter along its natural position are displaced from each other at least by roughly the diameter of the vessel such that the suction port necessarily is at or near the vessel wall. This is shown schematically in a fragmentary view in Fig. 9. Distal tip portion 190 has one or more curves. Several specific embodiments for the curved portion are presented above and below. As shown in Fig. 9, distal tip portion can have suction ports 192 and/or 194 near the extremes in the displacement of the device. Suction port 194 can be a side port or a port at the distal end of the catheter tip, although the ports are shown as side ports in Fig. 9.
  • the curved distal tip portion 190 has a perpendicular displacement "D" as shown in Fig. 9.
  • Displacement "D” corresponds with the distance that the tip naturally extends without constraints imposed by the vessel such that it is largest extent across the vessel that the distal tip portion can extends.
  • suction ports 192 and 194 are at or near the vessel wall.
  • "D” is greater than the diameter of the corresponding vessel such that the tip portion is bent from contact with the vessel wall that effectively constrains the displacement of the curved tip portion to a value less than "D.” Also, “D” involves a displacement beyond the natural outer diameter of the catheter "d” which is also depicted in Fig. 9.
  • catheters with one or more selected displacements "D” generally are used for commercial distribution such that a physician can select the appropriate sized catheter for the vessel.
  • the tips are one-size- fits-all for a particular vessel type, such as coronary arteries.
  • "D" is selected to be as large or larger than the largest vessel diameter that is anticipated for use of the device.
  • the distal tip portion can be formed from a material that is flexible enough such that the contact with the vessel wall does not damage the vessel wall.
  • a set of different tip sizes can be sold such that each design is intended for use in vessel over a range of sizes.
  • D can be selected to be at least about 7.5 mm, and in further embodiments to be about 7.0 mm.
  • D can be selected to be at least about 11 mm and in further embodiments to be about 10 mm.
  • D can be selected to be at least about 40 mm and in further embodiments to be about 35 mm.
  • d can be at least about 2 mm, in further embodiments, at least about 4 mm, and in other embodiments at least about 5 mm.
  • FIGs. 10-12 A specific embodiment is shown in Figs. 10-12 having a delivery configuration and a distinct curved configuration.
  • the distal tip portion 200 has an angled distal aspiration port 202, a curved flexible end section 204, a guide structure exit port 206 and a distal guide structure lumen 208 that accommodates guide structure 210.
  • guide structure 210 is located in a guide lumen 212 along most of the length of the catheter, although alternatively guide structure 210 can be designed with the guide structure located within the suction lumen 214.
  • the delivery configuration is shown in Fig. 1OA. In this configuration, guide structure 210 extends outward through exit port 206 and through distal lumen 208.
  • Guide structure 210 can be stiff enough to hold end section 204 relatively straight to facilitate passage of distal tip portion 200 to the selected location within the patient, while being flexible enough to provide for passage through a curving and branching network of vessels.
  • Fig. 1OA is consistent with an over the wire configuration.
  • the catheter can be a rapid exchange configuration, as shown in Fig. 1OB.
  • guide structure 210 also passes through guide port 216 such that guide structure 210 is associated with catheter 200 between guide ports 206 and 216 as well as with distal guide lumen 208.
  • guide structure 210 associates with thrombectomy catheter 201 through a distal guide lumen 203 adjacent distal suction port 205.
  • FIG. 1 IA A curved configuration of the device of Fig. 1OA is shown in Fig. 1 IA.
  • guide structure 210 exits through exit port 206 but does not pass through distal lumen 208. Since curved flexible end section 204 is unconstrained in this configuration, end section 204 resumes its natural curved structure, although this may be somewhat constrained, by a patient's vessel when it is located within a vessel.
  • the distal tip portion 200 is positioned at the desired location within a patient. Then, the guide structure 210 is withdrawn past distal lumen 208 to free end section 204.
  • a guide structure 220 can be formed with blades 222, 224, as shown in Fig. 1 IB. As blades 222, 224 are drawn into distal guide lumen, the blades cut through the structure, and the guide structure is released from the distal guide lumen such that the thrombectomy catheter assumes its curved configuration as shown in Fig. 1 IA.
  • the blades can be used cut the distal guide lumen for any of the embodiments in Figs. lOA-lOC. The number, shape and position of one or more blades can be selected appropriately by a person or ordinary skill in the art based on this description.
  • An alternative embodiment of a thrombectomy catheter configuration is shown in
  • guide structure 210 comprises a first material 226 and a second material 228 in which first material 226 is less flexible than second material.
  • the guide structure as depicted in Figs. 1 IA and 1 IB can similarly have materials with different flexibilities, but this structure of the guide structure is not relied upon to obtain the curved configuration shown in Fig. 1 IA.
  • first material 226 is withdrawn into exit port 206, curved flexible end section 204 bends since the force needed to maintain end section 204 relatively straight is greater than the force needed to keep in a straight orientation second material 228 of guide structure 210.
  • thrombectomy catheter 230 comprises a curved flexible tip portion 232 with a rapid exchange port 234.
  • Obturator 236 is a structure that is more rigid than tip portion 232.
  • Obturator 236 can slide relative to suction port 238 at the distal end of tip portion 232.
  • When extended, obturator 236 holds tip portion 232 in a straighter configuration.
  • When retracted, the unconstrained tip portion 232 assumes its unrestrained curved configuration.
  • An extended obturator 236 is depicted in Fig.
  • Fig. 13A while catheter 230 with a retracted obturator is depicted in Fig. 13B where tip portion 232 has its natural curve.
  • Obturator 236 is connected to a lever 238 projecting through slit 240.
  • Lever 238 is connected to wire 242.
  • wire 242 passes along the exterior of catheter 230 to its proximal end 244.
  • wire 242 can extend within catheter 230, such as through the suction lumen 246.
  • a suitable obturator 236 can be, for example, a cylindrical tubular element that can slide within the lumen of tip portion 232.
  • thrombectomy catheter 231 with an obturator 233 that extends along the length of the catheter.
  • the obturator can fill a substantial fraction of the suction lumen of the thrombectomy catheter, although the obturator may or may not have a roughly constant diameter over its length.
  • Thrombectomy catheter 231 has an angled cut opening 235 at its distal end.
  • Thrombectomy catheter 231 has a curved tip 237 that is held in a straight configuration by obturator 233 for delivery into the patient.
  • Obturator 233 has a guide lumen 239 such that obturator 233 can ride over guide structure 241 for delivery into the patient.
  • obturator 233 and guide structure 241 are removed. With the obturator removed, thrombectomy catheter 231 assumes its natural configuration with curved tip 237, as shown in Fig. 14B. Obturator 233 can have similar flexibility and can be formed from similar materials as catheter 231.
  • a rapid exchange obturator 251 is shown in Fig. 14C being used with thrombectomy catheter 231.
  • obturator 251 has a guide port 253 and a tapered tip 255 with a distal guide port 257.
  • obturator 251 rides over guide structure 241 with the guide structure extending between distal guide port 257 and side guide port 253.
  • aspiration catheter 231 Upon removal of guide structure 241 and obturator 251, aspiration catheter 231 again assumes a configuration with a curved tip as shown in Fig. 14B.
  • guide structure 241 can be withdrawn sufficient to release obturator 251 while being left in the patient for additional purposes.
  • a loading tool can be used to facilitate placement of the guidewire through guide port 253.
  • thrombectomy catheter 281 is used with obturator 233 and guide structure 241.
  • Aspiration catheter 281 has a curved tip 283 that is held straight by obturator 233 for deployment.
  • Catheter 281 also has a slit 285 extending from distal aspiration opening 287.
  • guide structure can extend through slit 285 to extend from aspiration catheter 281 when curved tip 283 is in its natural curved configuration.
  • Curved tip 283 can be formed with an embedded spring metal such as Nitinol ® or an elastic polymer such that slit 285 remains essentially closed except near the position at which guide structure 241 extends through slit 285.
  • Thrombectomy catheter 261 has a side aspiration port 263 along a curved segment 265.
  • the distal tip of thrombectomy catheter 261 tapers to a distal guide port 267.
  • Obturator 269 fits within suction lumen 271 of catheter 261.
  • Obturator 269 straightens curved segment 265 for delivery.
  • Obturator 269 comprises a guide lumen 273 for a guide structure 275.
  • guide structure 275 extends from guide port 267 and through guide lumen 273.
  • Fig. 15 B is the appropriate configuration for performing the thrombectomy procedure.
  • the guide structure may or may not be left in place.
  • Figs. 16A and 16B A further embodiment of a thrombectomy catheter with two configurations is shown in Figs. 16A and 16B. This embodiment is similar to the embodiment in Figs. 15A and 15B except that the guide structure itself functions as an obturator.
  • catheter 248 comprises a curved flexible tip portion 250 with a suction port 252 at the distal end of tip portion 250.
  • Guide structure 254 comprises a stiffer portion 256 and a more flexible portion 258.
  • thrombectomy catheter has a curved configuration without structural features to straighten the device during placement. Such an embodiment is shown in Fig. 17.
  • Thrombectomy catheter 260 has a curved tip portion 262 with a side suction port 264 and a guide exit port 266 at end of the catheter.
  • Tip portion 262 has three curves 272, 274, 276.
  • Suction port 264 is located along curve 274 such that the suction port can be is positioned at or near the wall of the vessel within the patient. Suction port could be similarly places along curve 272 or 276.
  • the tip portion is shown with three curves, in other embodiments, the tip portion has two curves (Figs. 5 and 6), four curves or more than four curves.
  • Tip portion 262 generally is sufficiently flexible to provide for the placement of tip portion 262 without difficulties from the curves. While this embodiment is shown as an over-the-wire design, a comparable device can be formed with a rapid exchange design.
  • thrombectomy catheter 280 comprises shaft 282 and tip portion 284.
  • Tip portion 284 has three curves 286, 288, 290.
  • Suction port 292 is located along curve 288.
  • a guide structure exit port 294 is located at the distal end of the catheter.
  • Curved tip 302 has the form of a bump with aspiration opening 304 along a proximal edge of the upper surface of the bump and a slit 308 along the lower surface of the bump.
  • a guide structure 310 passes through distal guide port 306 and exits the catheter along slit 308 such that the curvature is not significantly distorted due to forces from the guide structure.
  • Thrombectomy catheter 300 can be deployed with an obturator or other of the structures described herein to facilitate delivery. A similar embodiment is shown in Fig. 18C.
  • Thrombectomy catheter 301 has a curved tip 303 with an aspiration opening 305 and a distal guide port 307.
  • Thrombectomy catheter 301 has two guide ports 309, 311 as a substitute for slit 308 of thrombectomy catheter 300 in Fig. 18B.
  • Guide structure 313 passes through guide ports 309, 311 and distal guide port 307 such that thrombectomy catheter 301 can remain associated with guide structure 313 without significant interference with the natural curve of curved tip 303.
  • Thrombectomy catheter 301 can also be delivered with an obturator or other structure to facilitate delivery.
  • Thrombectomy catheter 321 comprises a distal guide port 323 and a rapid exchange port 325, although suitable catheter can be correspondingly formed in an over the wire format.
  • a guide structure 327 can extend through distal guide port 323 and rapid exchange port 325, as shown in Fig. 18D.
  • Curved suction arm 329 has an aspiration port 331 at the end of the arm. In this configuration, Guide structure 327 does not significantly interfere with suction. With this configuration, if suction arm 329 is formed from a flexible material, arm 329 generally deflects out of the way for convenient deployment while being properly positions for performing aspiration as it is moved in a proximal direction during the thrombectomy procedure.
  • Thrombectomy catheter 339 has a distal guide port through which a guide structure 341 can extend as shown in the figure.
  • the catheter has an over-the-wire design, although a rapid exchange version can be formed based on the rapid exchange configurations described herein.
  • Suction arm 343 extends from shaft 345.
  • Suction arm 343 has a side aspiration port 347. End 349 of suction arm 343 may or may not be attached to shaft 345.
  • Suction arm 343 can be formed from a flexible material such that it deflects during deployment of the catheter to facilitate deployment. The curvature of suction arm can be selected such that aspiration port 347 is positioned at the vessel wall during the thrombectomy procedure.
  • thrombectomy catheter 361 is deployed with an obturator 363 and a guide structure 365.
  • catheter 361 takes a configuration essentially as shown in Fig. 15B with thrombectomy catheter 261.
  • thrombectomy catheter has an aspiration opening 367 and an expandable tip 369.
  • Obturator 363 can extend through expandable tip 369 as shown in Fig. 18F.
  • expandable tip 369 reduces its expansion to form a guide port, such as shown in Fig.
  • Expandable tip 369 can be formed, for example, with a spring metal, such as a Nitinol ® , Nitinol ® embedded within a polymer, or an elastic polymer.
  • a feature on the catheter needs to be deployed, such as actuated or inflated, to partially block flow at a location upstream and/or downstream from the suction port.
  • a balloon mounted on the exterior of the shaft is one way to provide partial occlusion. For example, a low pressure balloon can be inflated once the catheter is tracked into position. After removal of thrombus, the balloon can be deflated and the catheter removed.
  • aspiration catheter 312 has a balloon structure 314 around the circumference of the catheter body.
  • a fluid such as saline or other non-toxic fluid, can be delivered through balloon lumen 316 to inflate the balloon, and the balloon can be correspondingly deflated through removal of the fluid.
  • the fluid can be delivered from the proximal end of the catheter, for example, using conventional approaches.
  • Aspiration catheter 312 has a curve 318 and a distal suction opening 320.
  • Thrombectomy catheter 322 has a balloon structure 324 around a portion of the circumference of the catheter body. Balloon lumen 326 can be used to control inflation of the balloon. The size, shape and positioning of balloon structure 324 can be selected to alter the flow in the vessel as desired.
  • a flap or other obtrusive feature can be mechanically actuated to increase the overall profile of the catheter.
  • Suitable flaps or the like can be formed, for example, from a soft polymer with shape memory, such as silicone, nylon, PEBAX ® , polyurethane, combinations thereof and the like. Alloys, such as stainless steel and/or Nitinol ® , can be used to further enhance the shape memory of a polymer.
  • the flap can be restrained against the shaft of the catheter with an external sheath that can be slid longitudinally to deploy the structure, or the structure can be mounted to the shaft to self-expand once the structure exits the guide catheter lumen. An example of such a structure is shown in Fig. 21.
  • Thrombectomy catheter 330 has a flap 332 secured at edge 334 to the catheter body.
  • Pullwire 336 can be used to deploy the flap to a partially occlusive position. The size and position of the flap can be selected to yield a desired partial occlusion of the flow.
  • a partial occlusion can be introduced using a braid incorporated into or onto the shaft.
  • a braid can be made from an alloy, such as stainless steel of Nitinol ® .
  • the braid can be bare or coated with a soft elastomeric polymer. Compressing the braid longitudinally causes the diameter to increase.
  • a pullwire can be used to induce the compression.
  • An embodiment is shown schematically in Fig. 22.
  • Thrombectomy catheter 340 has a braided structure 342 secured at edge 344 to the catheter body. Pullwire 346 can be used to deploy the braided structure to a partially occluding configuration. As shown in Figs.
  • thrombectomy catheters 300, 316, 326, 340 have a single curve and a suction lumen at the distal end of the catheter, although a similar partially occluding structured can be placed on other thrombectomy structures described herein.
  • the portions of the thrombectomy catheter can be formed from one or more biocompatible materials, including, for example, metals, such as stainless steel or alloys, e.g., Nitinol ® , or polymers such as polyether-amide block co-polymer (PEBAX ), nylon (polyamides), poryoleftns, polytetrafluoroethylene, polyesters, polyurethanes, polycarbonates, mixtures thereof, copolymers thereof or other suitable biocompatible polymers.
  • metals such as stainless steel or alloys, e.g., Nitinol ®
  • polymers such as polyether-amide block co-polymer (PEBAX ), nylon (polyamides), poryoleftns, polytetrafluoroethylene, polyesters, polyurethanes, polycarbonates, mixtures thereof, copolymers thereof or other suitable biocompatible polymers.
  • Radiopacity can be achieved with the addition of markers, such as platinum-iridium or platinum-tungsten or through radio-pacifiers, such as barium sulfate, bismuth trioxide, bismuth subcarbonate, powdered tungsten, powdered tantalum or the like, added to a polymer.
  • markers such as platinum-iridium or platinum-tungsten
  • radio-pacifiers such as barium sulfate, bismuth trioxide, bismuth subcarbonate, powdered tungsten, powdered tantalum or the like, added to a polymer.
  • markers such as platinum-iridium or platinum-tungsten
  • radio-pacifiers such as barium sulfate, bismuth trioxide, bismuth subcarbonate, powdered tungsten, powdered tantalum or the like
  • different sections of the thrombectomy catheter can be formed from different materials from other sections, and sections of the catheter can comprise a plurality of materials at different locations and/or at
  • a distal section or a portion thereof of the catheter may be desirable to form a distal section or a portion thereof of the catheter from an elastomeric polymer, such as suitable polyurethanes, polydimethyl siloxane and polytetrafluoroethylene.
  • selected sections of the catheter can be formed with materials to introduce desired stiffness/ flexibility for the particular section of the catheter.
  • a flexible portion at or near the distal end of the catheter can have a material with a Shore Durometer D value of no more than 50 to achieve desired tracking properties for placement of the catheter.
  • Suitable polymers include, for example, polyamides, i.e., nylons.
  • the wire can be braided, coiled or otherwise placed over a polymer tubing liner with some tension. A polymer jacket is then placed over the top. Upon heating over the softening temperature of the polymer and subsequent cooling, the wire becomes embedded within the polymer.
  • the liner and jacket can be of the same or different materials.
  • Suitable wire includes, for example, flat stainless steel wire. Some specific examples are described below. The wire adds additional mechanical strength while maintaining appropriate amounts of flexibility.
  • shaft 106 forming the majority of the length of the catheter is somewhat rigid but flexible enough to bend along the patient's vasculature or other series of vessels. The bending of shaft 106 can cause contact with the vessel wall near braches and/or turns in the vessels, but the flexibility of the tube permits this contact without damaging the vessel.
  • shaft 106 is formed to have desired resilience with appropriate flexibility by embedding a metal wire within a polymer tube.
  • the metal wire can be a flat ribbon made of stainless steel or Nitinol ® with sizes from about 0.0005 inches to about 0.002 inches in thickness and from about 0.001 inches to about 0.005 inches wide.
  • the polymer can be a thermoplastic polymer, such as nylon, PEBAX , polyurethane, silicone or mixtures thereof.
  • a coil or braid is threaded onto a polytetrafluoroethylene coated mandrel.
  • a thermoplastic tube is longitudinally split and loaded over the wire on the mandrel.
  • Inert polymer heatshrink tubing can be placed over the thermoplastic.
  • Suitable heat shrink tubing is available in various polymers, such as fluorinated ethylene proplyene copolymer (FEP) and polytetrafluoroethylene (PTFE), which are available from Zeus Incorporated, Orangeberg, South Carolina.
  • FEP fluorinated ethylene proplyene copolymer
  • PTFE polytetrafluoroethylene
  • the tip portion generally is more flexible than shaft 106.
  • the tip portion generally is resilient enough that the curve of the tip portion is not lost while manipulating the device during delivery.
  • Thermoset polymer materials can be used to form the tip of the catheter.
  • a material with a Shore D Durometer value of no more than 50 can be used to achieve desired tracking properties for placement of the catheter as well desired contact properties with the vessel wall.
  • a small portion of the tip at the side port can be formed from a less flexible material such that the suction function may be less affected from the deformation of the material. An example is shown in Fig. 23.
  • segment 352 is formed from a material that is stiffer than adjoining segments 354, 356. As shown in Fig. 23, segment 352 is joined at angled interfaces with adjacent segments 354, 356, although in other embodiments straight interfaces around the entire circumference can be used or the stiffer portion may not include the entire circumference of the catheter body.
  • the materials can be joined using thermal bonding techniques, such as conventional thermal bonding techniques.
  • a portion of the tip generally is made radiopaque. This can be done through the introduction of a suitable material, such as the radiopaque materials discussed above. Radiopaque marker bands 358, 360, 362 are shown in Fig. 23, as an example of suitable placement.
  • the thrombectomy catheter described herein can be used in conjunction with other medical treatment devices, generally devices useful for the treatment of thrombosis and/or removal/collection of emboli.
  • Suitable ancillary devices include, for example, filters, angioplasty balloons, stents, abrasive devices and the like. These devices may or may not be used with the same guide structure as the thrombectomy catheter.
  • a treating physician or other health care professional has added flexibility in designing an appropriate treatment for a particular patient.
  • Filters can be used to collect emboli resulting from thrombus that is dislodged from the thrombectomy procedure but that avoid removal by way of the suction.
  • Commercially available filtration devices include, for example, the RX AccunetTM Embolic Protection System, available from Guidant, Indianapolis, IN. This Guidant filter is formed from a nickel-titanium alloy in a mesh.
  • Boston Scientific markets FilterWire EZTM Embolic Protection System. The Boston Scientific device has a polyurethane filter. See also, U.S. Patent 6,695,813 to Boyle et at., entitled "Embolic
  • an embolism protection device can comprise a polymeric substrate (media, sponge), especially an expandable polymer, such as a swelling polymer, a memory polymer or a compressed polymer.
  • Embolism protection devices comprising a swelling polymer, such as hydrogels and/or shape memory fibers, are described further in copending U.S. Patent application serial number 10/414,909 to Ogle, entitled “Embolism Protection Devices," incorporated herein by reference. This pending application also describes the delivery of a bioactive agent in conjunction with the embolism protection device.
  • the fibers can be organized into a bundle that is deployed within the vessel.
  • Embolism protection devices formed from fibers are described further in copending U.S. Patent application serial number 10/795,131 to Ogle et at., entitled “Fiber Based Embolism Protection Device,” incorporated herein by reference and 10/979,439 to Galdonik et al., entitled “Steerable Device having A Corewire Within A Tube And A Combination With A Functional Medical Component,” incorporated herein by reference.
  • Suitable angioplasty balloons are described further, for example in U.S. Patent 6,132,824 to Hamlin, entitled “Multilayer Catheter Balloon,” incorporated herein by reference.
  • Stent delivery is described further, for example, in U.S. Patent 6,610,069 to Euteneuer et al., entitled “Catheter Support For Stent Delivery,” incorporated herein by reference.
  • Various stents and angioplasty balloons are commercially available. Drug coated stents are presently commercially available, such as the pacitaxel eluting TaxusTM stent from Boston Scientific and the sirolimus eluting CypherTM stent from Johnson & Johnson. Stents and balloons associated with therapeutic agents are described further in U.S.
  • thrombectomy catheter can be used before and/or after the use of the balloon or delivery of the stent to remove thrombus. Use of the present thrombectomy catheter in combination with stent delivery is described further below.
  • the thrombectomy catheter can be used to remove thrombus from any reasonable vessel within a patient.
  • the guide structure may or may not be removed after positioning the catheter, and the selection of an appropriate procedure may be influenced by the design of the catheter and/or the use of ancillary medical devices.
  • the catheter can be moved to remove thrombus from a swept region.
  • the catheter in an upstream direction, which generally corresponds with a distal to proximal direction for common placements of the catheter in most procedures. While it is generally desirable to use the thrombectomy catheter in a less invasive procedure, the vessel can be exposed for entry in a surgical procedure in some embodiments. Three specific applications are described in more detail below to further illustrate features of the methodology.
  • the deflection distance "D" is generally selected to be larger than the largest vessel diameters selected for use with the particular catheter.
  • the vessel walls deflect the catheter into a strained configuration with a suction port at or near the vessel wall depending on the location of the suction port in relation to the curves of the tip portion.
  • a suction port at or near the vessel wall depending on the location of the suction port in relation to the curves of the tip portion.
  • Such deflection is depicted in Fig. 24.
  • the un-deflected tip portion 370 is depicted in the left portion of Fig. 24, tip portion 370 is shown in a strained, deflected configuration within vessel 372.
  • suction port can be within 10 percent of the vessel diameter of the vessel wall, in other embodiments within about 5 percent of the vessel diameter of the vessel and in further embodiments within about 2 percent of the vessel diameter of the vessel wall.
  • vessel 400 has a guidewire 402 extending from a guide catheter 404.
  • Vessel 400 has a lesion 406 with thrombus/debris.
  • thrombectomy catheter 408 can be brought into the vessel along guidewire 402.
  • the tip 410 of thrombectomy catheter 408 is inserted past lesion 406.
  • thrombectomy catheter 408 has a structure corresponding to the catheter in Figs. 10-12.
  • Guidewire 404 can be withdrawn to release the tip to its suction configuration, and the guidewire can then be extended outward again as shown in Fig. 28, although alternatively the guidewire can be removed from the patient.
  • Thrombectomy catheters with alternative tip designs can be used similarly, and the tip can be correspondingly positioned in a curved configuration unless the catheter design does not have a delivery configuration.
  • suction is used to remove thrombus from lesion 406 through catheter 408.
  • Dislodged thrombus (emboli) 412 is depicted within the catheter following removal through the suction lumen 414.
  • the catheter tip 410 can be moved longitudinally along a selected length of vessel 400 as well as circumferentially around the inner circumference of the vessel. Suction can be applied until the desired sections of the vessel interior have been subjected to suction.
  • a treatment device 420 such as a stent or angioplasty balloon, is being applied at lesion 406 following completion of the suction process and removal of thrombectomy catheter 408.
  • suction can be initiated at a selected time to achieve desired objectives for the particular patient.
  • suction can be applied continuously or intermittently.
  • suction can be initiated at a selected time once the catheter tip has cleared the guide catheter.
  • suction can optionally be initiated before transitioning the catheter tip to a curved configuration.
  • suction is contrary to the flow within the vessel.
  • the suction rate can be greater than the flow within the vessel or some fraction of the flow.
  • the suction rate can be no more than about 125 percent of the vessel flow, in further embodiments, no more than about 110 percent of the vessel flow, in further embodiments from about 25 percent to about 100 percent and in additional embodiments from about 50 percent to about 80 percent of the unrestricted flow through the vessel.
  • the suction rate can be 125 percent of the flow or 125 ml per minute or in further embodiments from about 50 ml to about 90 ml per minute.
  • the size of the syringe can be selected based on the flow in the vessel.
  • a syringe can be filled in roughly 10 to 30 seconds, for example, for any sized vessel.
  • Multiple syringes can be filled to generate a desired degree of suction.
  • the catheter tip can be moved longitudinally along a selected path and rotated to a different orientation along the circumference of the vessel wall and then moved longitudinally again. This can be repeated as desired.
  • the catheter tip is moved circumferentially around the vessel inner wall, then moved longitudinally to position the catheter tip at another transverse position where it is moved circumferentially again, and the process is repeated until the desired section of the vessel has been treated, hi some embodiments, the circumferential and longitudinal motions are coupled to combine into a spiral motion. Selected combinations of motion can be use to yield the desired thrombus removal.
  • vessel 400 has a stent 422.
  • the stent may or may not have been delivered following thrombectomy based on suction.
  • thrombectomy catheter 408 is delivered to position catheter tip 410 within the interior of stent 422.
  • Suction along with suitable movement of the catheter can be used to remove thrombus along the interior of the stent following deployment of the stent.
  • the thrombectomy catheter can be used to mitigate certain undesired by products of the stent delivery, namely the ultimate formation of emboli.
  • heart 430 is depicted with a thrombectomy catheter 432 on guidewire 434 within coronary artery 436.
  • Thrombectomy catheter 432 can be delivered, for example, using conventional approaches through an incision in the patient's groin or wrist up through arteries to the aorta and into the coronary artery.
  • a carotid endarterectomy is depicted using a thrombectomy catheter 450 introduced into a patient's carotid artery 452 through a hemostatic valve 454 at an incision into the patient's neck. In this less invasive procedure, strokes can be mitigated through the removal of thrombus within the carotid artery.
  • the aspiration catheters described herein can be used for a variety of procedures.
  • the improved aspiration catheters can be used generally for any procedures that use an aspiration catheter to take advantages of the improved delivery of the catheter.
  • the aspiration catheters are particularly useful for the removal of an embolism protection device from the vessel of a patient if the aspiration catheters have a suction port at the distal tip.
  • the aspiration can be effective to capture emboli that may be released while the embolism protection device is being converted from a deployed orientation to an appropriate orientation for removal.
  • the embolism protection device can be drawn into a sheath, generally the distal end of the aspiration catheter.
  • aspiration can be applied during a portion of the period in which the aspiration catheter is being put into position while the embolism protection device is deployed in a filtering configuration. Radiopaque markers on the medical devices can be used for positioning during the various steps of the process.
  • Many of improved designs described above provide for improved tracking of the catheter over a guide structure during deployment. Many of the designs have tighter tracking along the guide structure and/or at least partial occlusion of a distal port to reduce the chances of snagging of the catheter during delivery. If there is snagging during delivery, the catheter can be gently pulled back, turned, for example, a quarter turn, and advanced again. In general, this approach can be successful for the delivery of the catheter into even very difficult to reach vessels.
  • An embolism protection device can be withdrawn into the tip of the catheter. To do this, generally the catheter is left stationary and the device is pulled into the catheter, although in principle the catheter can be moved in the process as an alternative or in addition to moving the device.
  • an embolism protection device with a three dimensional matrix provides for removal of the device into the aspiration catheter without blocking suction into the catheter through flow through the matrix and/or by having a recovery configuration that does not block flow, although a side port in the aspiration catheter can complement aspiration through the distal tip of the catheter.
  • the amount of disruption of the flow that can be safely tolerated can be estimated, such that the process for the recovery of the embolism protection device can be accordingly determined.
  • the suction generally is applied starting shortly before the recovery process begins.
  • suction can be applied while the aspiration catheter is being put into position while the embolism protection device is deployed in a filtering configuration.
  • Suction can be applied once the aspiration catheter clears the introducer catheter until the aspiration catheter is near the filter or for some fraction of this time.
  • one or two syringes can be withdrawn during the positioning of the aspiration catheter for recovery of a filter.
  • Suction generally can be maintained during the constriction of the device configuration for fitting within the opening of the aspiration catheter and while the device is drawn within the catheter.
  • the suction generally is stopped once the device is within the aspiration catheter, and the device generally is not moved further relative to the aspiration catheter.
  • the embolism protection device can be converted from a deployed configuration across the vessel lumen to a recovery configuration, generally with a reduced area across the cross section of the vessel lumen, in which the device fits within the aspiration catheter.
  • a recovery configuration By directly converting the embolism protection device to a recovery configuration, the embolism protection device can be formed without structural elements, such as metal struts, to facilitate the mechanical collapse of the device through pressure against the catheter end. This change of configuration can be accomplished with an actuation element that directly converts the device between different configurations.
  • the recovery configuration may or may not be similar to the delivery configuration.
  • an actuation element transforms the embolism protection device between delivery configuration to a deployed configuration and subsequently from a deployed configuration to a recovery configuration.
  • some type of gripping or engaging tool can be used to mechanically compress the embolism protection device to a recovery configuration.
  • the process of drawing of the embolism protection device into the distal compartment can compress the embolism protection device into the recovery configuration.
  • the end of the distal compartment can be tapered and/or the proximal end of the embolism protection device can be tapered to facilitate the entrance of the initial portion of the device into the compartment.
  • the transformation into the recovery configuration and the loading of the device into the distal compartment can be simultaneous steps or sequential steps.
  • the overall timing of the recovery process involves a balance between several factors within the overall objective of keeping the period of application of suction within desired ranges.
  • the suction is not applied for more than about 10 seconds, in some embodiments no more than about 5 seconds and in further embodiments no more than about 2 seconds prior to commencing the transformation of the device to the recovery configuration.
  • the suction generally is applied for no more than about 10 second, in some embodiments no more than about 5 seconds and in further embodiment no more than about 2 seconds after the embolism protection device is loaded into the distal compartment.
  • the suction is contrary to the flow within the vessel, which is otherwise relatively unrestricted.
  • the suction rate can be greater than the flow within the vessel or some fraction of the flow.
  • the suction rate is greater than the natural flow rate, the suction tends to draw fluid from both sides of the embolism protection device into the aspiration catheter. If the suction rate is less than the natural flow rate, the suction tends to draw fluid from the portion of the vessel adjacent the opening of the aspiration catheter.
  • the suction rate can be selected to balance the disruption of the flow with the collection rate for any released emboli.
  • focal suction can be used to reduce the effect on vessel flow.
  • Focal suction effectively reverses flow in a small region of the vessel but not overall within the vessel.
  • This focal suction can effectively remove debris from the base of an embolism protection device and capture emboli released from the filter without needing to draw such volumes of blood as to completely reverse flow in the vessel.
  • the flow rate can change at different points in the recovery process.
  • the suction rate is generally greater at the start of the recovery process and reduced once the device is collapsed to a recovery configuration.
  • syringes can be convenient. Desirable results have been obtained with a 30 cubic centimeter, i.e., 30 ml, syringe.
  • the rate of filling the syringe generally depends on the diameter of the shaft of the catheter. Typical times to fill a syringe range from about 10 second to about 25 seconds with shorter times for larger diameter catheters, which are generally used in larger blood vessels.
  • a first syringe is filled during delivery of the catheter into position.
  • a second syringe is filled while collapsing the filter and withdrawing the filter into the tip of the catheter.
  • Figs. 34-37 depict the generic recovery of a fiber-based embolism protection device.
  • Fig. 34 depicts an aspiration catheter 500 within a patient's vessel 502 a short distance downstream from embolism protection device 504.
  • Emboli 506 are schematically depicted within device 504 and along the downstream surface of the device. Flow through the vessel is depicted with flow arrows 508. As shown in Fig. 35, suction is applied just before embolism protection device 504 is reconfigured to a recovery configuration. Flow from the suction is depicted with flow arrows 510. Fig. 36 depicts embolism protection device 504 reconfigured to a recovery configuration. Suction is still being applied. Referring to Fig. 37, embolism protection device 504 is withdrawn into aspiration catheter 500. Suction has been turned off in Fig. 37 with essentially unrestrained flow restored in vessel 502.
  • the medical devices described herein are generally packaged in sterile containers for distribution to medical professionals for use.
  • the articles can be sterilized using various approaches, such as electron beam irradiation, gamma irradiation, ultraviolet irradiation, chemical sterilization, and/or the use of sterile manufacturing and packaging procedures.
  • the articles can be labeled, for example with an appropriate date through which the article is expected to remain in fully functional condition.
  • the components can be packaged individually or together.
  • kits described herein can be packaged together in a kit for convenience.
  • the kit can further include, for example, labeling with instruction for use and/or warnings, such as information specified for inclusion by the Food and Drug administration.
  • labeling can be on the outside of the package and/or on separate paper within the package.

Abstract

L'invention concerne des sondes d'aspiration présentant des bouts courbes, qui peuvent être utilisées comme sonde pour thrombectomie. Selon l'invention, une lumière de succion s'étend depuis l’extrémité proximale de la sonde ou à proximité jusqu’à un orifice de succion au bout de la sonde ou à proximité. Les courbes de la sonde pour thrombectomie peuvent être sélectionnées de façon à placer un orifice de succion au niveau d'une paroi de vaisseau ou à proximité pour un enlèvement plus efficace du thrombus résultant de l'orientation de la succion dans la direction du thrombus. Dans certains modes de réalisation de l'invention, le bout de la sonde peut changer d'une première configuration destinée à la mise en place de la sonde dans le vaisseau à une deuxième configuration souhaitée, qui est plus courbe, destinée à l'application de la succion. La sonde de l'invention peut être déplacée dans une direction circonférentielle et/ou latérale pour couvrir des portions sélectionnées de la paroi de vaisseau interne. Dans certains modes de réalisation de l'invention, une structure partiellement occlusive peut être utilisée pour réduire et/ou rediriger le flux à l'intérieur du vaisseau afin d'améliorer la performance de la thrombectomie.
EP06813517A 2005-08-18 2006-08-17 Sonde pour thrombectomie et autres sondes d'aspiration Withdrawn EP1940500A4 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US11/207,169 US8021351B2 (en) 2005-08-18 2005-08-18 Tracking aspiration catheter
US11/206,680 US7938820B2 (en) 2005-08-18 2005-08-18 Thrombectomy catheter
US11/409,147 US8758325B2 (en) 2005-08-18 2006-04-21 Rapid exchange catheter
PCT/US2006/032189 WO2007022383A2 (fr) 2005-08-18 2006-08-17 Sonde pour thrombectomie et autres sondes d'aspiration

Publications (2)

Publication Number Publication Date
EP1940500A2 true EP1940500A2 (fr) 2008-07-09
EP1940500A4 EP1940500A4 (fr) 2010-12-29

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EP06813517A Withdrawn EP1940500A4 (fr) 2005-08-18 2006-08-17 Sonde pour thrombectomie et autres sondes d'aspiration

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EP (1) EP1940500A4 (fr)
JP (1) JP2009504343A (fr)
WO (1) WO2007022383A2 (fr)

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JP6270839B2 (ja) * 2012-07-19 2018-01-31 ボストン サイエンティフィック サイムド，インコーポレイテッドＢｏｓｔｏｎ Ｓｃｉｅｎｔｉｆｉｃ Ｓｃｉｍｅｄ，Ｉｎｃ． ガイド延長カテーテルおよび医療装置アセンブリ
EP3247444B1 (fr) * 2015-01-20 2023-03-29 Q'Apel Medical, Inc. Structures tubulaires à support variable
DE202015002060U1 (de) * 2015-03-17 2015-11-25 Gerhard-Friedrich Horak Infusions- und Aspirations- Catheter (IAC) (Katheter zur Entfernung von Thromben und Applikation von Medikamenten)
JP2016174811A (ja) * 2015-03-20 2016-10-06 テルモ株式会社 カテーテルシステム
JP2019187458A (ja) 2016-08-29 2019-10-31 テルモ株式会社 吸引カテーテルおよび吸引システム並びに処置方法
JP2019187457A (ja) * 2016-08-29 2019-10-31 テルモ株式会社 吸引システムおよび処置方法
WO2018075700A1 (fr) 2016-10-18 2018-04-26 Boston Scientific Scimed, Inc. Cathéter d'extension de guidage
CN111867665B (zh) * 2018-03-06 2022-10-25 美敦力瓦斯科尔勒公司 快速更换球囊导管
CN114081579A (zh) * 2021-11-29 2022-02-25 上海市第十人民医院 一种脑卒中机械取栓装置及其应用

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Title
See also references of WO2007022383A2 *

Also Published As

Publication number Publication date
EP1940500A4 (fr) 2010-12-29
WO2007022383A2 (fr) 2007-02-22
WO2007022383A3 (fr) 2009-04-23
JP2009504343A (ja) 2009-02-05

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