US20070244504A1 - Embolic protection system - Google Patents
Embolic protection system Download PDFInfo
- Publication number
- US20070244504A1 US20070244504A1 US11/613,432 US61343206A US2007244504A1 US 20070244504 A1 US20070244504 A1 US 20070244504A1 US 61343206 A US61343206 A US 61343206A US 2007244504 A1 US2007244504 A1 US 2007244504A1
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- United States
- Prior art keywords
- filter
- guidewire
- vasculature
- catheter
- retrieval
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- Abandoned
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-
- 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
- A61M25/104—Balloon catheters used for angioplasty
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2/0105—Open ended, i.e. legs gathered only at one side
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2/0108—Both ends closed, i.e. legs gathered at both ends
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2/011—Instruments for their placement or removal
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2/013—Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/958—Inflatable balloons for placing stents or stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
- A61B2017/22035—Gripping instruments, e.g. forceps, for removing or smashing calculi for retrieving or repositioning foreign objects
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
- A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2002/018—Filters implantable into blood vessels made from tubes or sheets of material, e.g. by etching or laser-cutting
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0004—Rounded shapes, e.g. with rounded corners
- A61F2230/0006—Rounded shapes, e.g. with rounded corners circular
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0004—Rounded shapes, e.g. with rounded corners
- A61F2230/0008—Rounded shapes, e.g. with rounded corners elliptical or oval
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0067—Three-dimensional shapes conical
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0073—Quadric-shaped
- A61F2230/008—Quadric-shaped paraboloidal
Abstract
An embolic protection filter system comprises a collapsible embolic protection filter 62 having a collapsed configuration for delivery of the filter, and a deployed configuration and a temporary lumen defining member 60. The lumen defining member 60 is used for loading a filter-containing delivery catheter 63 onto a guidewire 65. After loading, the member 60 can be removed by pulling on a tab 61.
Description
- This is a continuation of pending prior application Ser. No. 11/534,004 filed Sep. 21, 2006 which is a continuation of pending prior application Ser. No. 10/379,434 filed Mar. 5, 2003, which claims benefit of Provisional Application No. 60/361,340 filed Mar. 5, 2002. The entire disclosures of the prior applications, application Ser. Nos. 11/534,004, filed Sep. 21, 2006, 10/379,434, filed Mar. 5, 2003, and 60/361,340, filed Mar. 5, 2002, priority of which is claimed under 35 U.S.C. §119(e), are considered part of the disclosure of the present application and are incorporated herein by reference.
- This invention relates to a transvascular embolic protection system for safety capturing and retaining embolic material released during an interventional procedure while maintaining blood flow.
- Embolic protection systems of this general type are described in our published international patent applications WO 01/80776 and WO 01/80777.
- There is an economical and clinical need to provide an embolic protection system which will be easy and convenient for a clinician to prepare for use, to deploy and to retrieve. In addition there is a need to provide such a system which is suitable for use with standard medical equipment and will facilitate a wide range of clinical procedures to be carried out.
- According to the invention, there is provided an embolic protection filter for deployment in a vasculature, the filter having an inlet end and an outlet end, the inlet end having one or more inlet openings sized to allow blood and embolic material enter the filter, and the outlet end of the filter having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter;
-
- the filter being movable between a collapsed configuration for movement through a vasculature, and an outwardly extended configuration for deployment in a vasculature;
- the filter at least in the collapsed configuration having a guidewire lumen defined at least partially therethrough for passing the filter over a guidewire;
- wherein the guidewire lumen is defined by a lumen-defining member which is movable or removable reactive to the filter.
- In one embodiment, the lumen-defining member is a substantially tubular member.
- In one embodiment, the tubular member has a slit extending the length thereof for removal of the member from a guidewire.
- In another embodiment, the lumen-defining member comprises a portion of a delivery system.
- Preferably the lumen-defining member comprises a pusher element of the delivery system, the pusher being movable from an extended lumen-defining configuration for loading of a filter to a retracted configuration for deployment of the filter.
- According to another aspect of the invention, there is provided an embolic protection filter for deployment in a vasculature, the filter having an inlet end and an outlet end, the inlet end having one or more inlet openings sized to allow blood and embolic material enter the filter, and the outlet end of the filter having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter;
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- the filter being movable between a collapsed configuration for movement through a vasculature, and an outwardly extended configuration for deployment in a vasculature in apposition with a vasculature wall;
- in the outwardly extended configuration the filter exerting an outward radial force on a vasculature wall sufficient to retain the filter in position against substantial longitudinal movement.
- In one embodiment, the filter comprises a filter body and a filter support frame to support the filter body in the outwardly extended configuration in apposition with a vasculature wall, the filter support frame providing the outward radial force.
- In one embodiment, the filter comprises a low-friction outer layer.
- Preferably the outer layer is of a hydrophilic material.
- In one embodiment, the filter comprises an inflatable member to enhance the outward radial force.
- In another embodiment, the filter defines a guidewire lumen for passing the filter over a guidewire.
- In one embodiment, the filter comprises an anchor for fixing the filter to the vasculature in the deployed configuration.
- In another embodiment, the filter comprises a filter body and a filter support frame to support the filter body in the deployed configuration.
- In one embodiment, the support frame comprises the anchor.
- In one embodiment, the filter body comprises the anchor.
- In another embodiment, the anchor comprises a plurality of anchor elements.
- In one embodiment, the anchor elements are spaced-apart circumferentially around the filter when the filter is in the deployed configuration.
- In one embodiment, the support frame comprises at least one support hoop.
- In another embodiment, the support frame has a longitudinal aspect.
- In a further embodiment, the filter is self supported in a vasculature in the absence of a guidewire.
- According to another aspect of the invention, there is provided an embolic protection filter assembly for deployment in a vasculature, the assembly comprising:—
-
- a filter having an inlet end and an outlet end, the inlet end having one or more inlet openings sized to allow blood and embolic material enter the filter, and the outlet end of the filter having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter; and
- a receiver to guide a docking device into association with the filter.
- In one embodiment, the filter has a guidewire lumen for passing the filter over a guidewire, and the receiver is configured to guide a guidewire into the guidewire lumen
- In one embodiment, the guidewire lumen extends only partially through the filter.
- In another embodiment, the receiver is configured to guide a coupling member towards the filter for coupling to the filter.
- In one embodiment, the receiver comprises a funnel.
- In another embodiment, the funnel is movable between a collapsed configuration for movement through a vasculature, and an outwardly extended configuration for guiding a docking device.
- In one embodiment, the funnel is biased towards the outwardly extended configuration.
- In another embodiment, the funnel comprises a funnel body and a funnel support to support the funnel body in the outwardly extended configuration.
- In one embodiment, the funnel body comprises a membrane. In a further embodiment, the funnel support comprises a plurality of pivotable fingers.
- Preferably the receiver comprises an approach channel.
- In one embodiment, the channel is provided by a lumen in a catheter.
- In another embodiment, the receiver is mounted to the filter.
- In one embodiment, the receiver is detachably mounted to the filter.
- In another embodiment, the receiver is separate from the filter. In a further embodiment, the receiver has means to space the receiver from the wall of a vasculature.
- Preferably the spacing means comprises an inflatable member to engage the wall of a vasculature.
- In one embodiment, the receiver is at least partially provided by a wall of the filter.
- In another embodiment, the receiver is at least partially provided by a wall of the filter at the inlet end of the filter.
- In a further embodiment, the receiver is at least partially provided by a wall of the filter at the outlet end of the filter.
- In one embodiment, the receiver extends proximally of the inlet end of the filter.
- In another embodiment, the receiver is located distally of the inlet end of the filter.
- In a further embodiment, the receiver is radially offset from the longitudinal axis of the filter.
- According to another aspect of the invention there is provided, an embolic protection system comprising:—
-
- an embolic protection filter assembly as claimed in any of
claims 21 to 43; and - a docking device which may be guided by the receiver into association with the filter.
- an embolic protection filter assembly as claimed in any of
- In one embodiment, the docking device comprises a guidewire.
- In one embodiment, the docking device comprises a coupling member.
- According to another aspect of the invention, there is provided an embolic protection filter having an inlet end and an outlet end, the inlet end having one or more inlet openings sized to allow blood and embolic material enter the filter, and the outlet end of the filter having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter.
-
- the filter having a guidewire aperture for passing the filter over a guidewire; and
- the filter comprising a seal to seal the guidewire aperture.
- Preferably the seal is self-closing.
- In one embodiment, the seal is located at a proximal end of the filter, and/or at a distal end of the filter.
- In one embodiment, the filter has a tubular member extending from the guidewire aperture to define a guidewire lumen through the tubular member.
- In another embodiment, the tubular member extends through at least part of the filter.
- In one embodiment, the tubular member is radially offset from the longitudinal axis of the filter.
- In one embodiment, the seal is an annular member around the guidewire aperture, the annular member being closable down to seal the guidewire aperture.
- Preferably the annular member is a tube.
- In one embodiment, the annular member comprises a soft membrane.
- In one embodiment, the annular member comprises two or more circumferentially overlapping flaps.
- According to a further aspect of the invention, there is provided a retrieval catheter for retrieving a medical device deployed in a vasculature, the catheter comprising:—
-
- an outer catheter body; and
- an inner coupling member having means for coupling to a medical device deployed in a vasculature;
- the catheter body being movable distally relative to the coupling member to retrieve a coupled medical device into the catheter body.
- In one embodiment, the coupling means comprises a male or female member on the coupling member for engagement with a corresponding female or male member on the medical device.
- In one embodiment, the male member is movable between a low-profile configuration and an outwardly protruding configuration.
- In one embodiment, the male member is biased towards the outwardly protruding configuration.
- In another embodiment the male member is of a resilient material.
- Preferably the coupling means is substantially arrow-head shaped.
- In one embodiment, the male member is in the form of a hook for hooking around a female member on the medical device.
- In one embodiment, the male member is in the form of a hook for hooking around a tether arm on the medical device.
- In one embodiment, the tether arm is at a proximal end of the medical device.
- In another embodiment, the tether arm is located within the medical device.
- In one embodiment, the coupling means comprises at least one female member on the coupling member for engagement with at least one male member on the medical device.
- In one embodiment, the female member is in the form of a loop for looping around a protruding male member on the medical device.
- In one embodiment, the coupling means comprises a pair of jaws on the coupling member, the jaws being movable between an outwardly protruding configuration and a low-profile configuration to grasp the medical device.
- In one embodiment, the retrieval catheter comprises an actuator to move the jaws to the outwardly protruding configuration.
- In another embodiment, the actuator is movable longitudinally relative to the jaws to move the jaws in a camming arrangement to the outwardly protruding configuration.
- In a further embodiment, the jaws are biased towards the low-profile configuration.
- In one embodiment, the catheter body is engageable with the jaws to move the jaws to the low-profile configuration.
- In another embodiment, the jaws are biased towards the outwardly protruding configuration.
- In a further embodiment, the coupling member is at least partially of a magnetic material for magnetic coupling to an oppositely charged magnetic portion of the medical device.
- In one embodiment the retrieval catheter comprises means to axially elongate a deployed medical device to collapse the medical device to a low-profile configuration for retrieval into the catheter body.
- In one embodiment, the elongation means comprises a second coupling member movable relative to the first coupling member to collapse the medical device.
- In another embodiment, the second coupling member comprises a pusher member movable distally relative to first coupling member to engage a deployed medical device distally of the first coupling means and thereby collapse the medical device.
- In a further embodiment, the catheter body has a guidewire lumen extending partially therethrough for passing the catheter body over a guidewire in a rapid exchange manner.
- In one embodiment, the guidewire lumen is offset radially from the coupling member.
- According to one embodiment, there is provided a retrieval catheter for retrieving an embolic protection filter deployed in a vasculature.
- In another aspect of the invention there is provided an embolic protection filter for deployment in a vasculature, the filter having an inlet end and an outlet end, the inlet end having one or more inlet openings sized to allow blood and embolic material enter the filter, and the outlet end of the filter having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter;
-
- the filter being movable between a collapsed configuration for movement through a vasculature, and an outwardly extended configuration for deployment in a vasculature;
- the filter at least in the collapsed configuration having a guidewire lumen defined at least partially therethrough for passing the filter over a guidewire;
- wherein the guidewire lumen is defined by a lumen-defining member which is spaced proximally of the distal end of the filter.
- In one embodiment, the guidewire lumen is defined by a tubular member.
- In another embodiment, the tubular member is mounted to the filter.
- Preferably the filter comprises a snare engaging feature.
- Preferably the snare engaging feature is radiopaque.
- In another aspect the invention provides a method for the capture and removal of embolic material from a vasculature during an interventional procedure comprising the steps of:—
-
- providing a collapsible embolic protection filter having a collapsed configuration for delivery of the filter, and a deployed configuration;
- advancing a guidewire through a vasculature;
- crossing a desired treatment location with the guidewire;
- deploying the filter distal to the treatment location;
- carrying out an interventional procedure at the treatment location, embolic material generated during the treatment procedure being captured by the deployed filter;
- advancing a retrieval device;
- engaging the filter with the retrieval device independent of the guidewire; and
- withdrawing the retrieval device and the filter from the vasculature.
- In one case, after crossing a treatment location with the guidewire the embolic protection device is introduced over the guidewire.
- In one case, the deployed filter is retained independent of the guidewire against substantial longitudinal movement.
- In another case, the filter applies a radial force to the vasculature to substantially prevent movement of the filter relative to the vasculature in the deployed configuration.
- In one case, the filter in the deployed configuration is anchored to the vasculature.
- In one case, the method comprises the step of releasing the filter from the vasculature before retrieving the filter.
- In another case, the filter is simultaneously released and retrieved by moving a retrieval catheter distally relative to the filter.
- In one case the filter is released prior to retrieving the filter.
- In one case, the method comprises the step of axially elongating the filter to release the filter.
- According to another aspect the method comprises the steps of:—
- withdrawing the guidewire from the filter and/or the desired treatment location; and
- subsequently placing a guidewire in the filter.
- In one case, the same guidewire is placed in the filter.
- In another case, another guidewire is placed in the filter.
- In one case, the interventional device is introduced over the guidewire for carrying out the interventional procedure.
- In one case, the interventional procedure comprises a stenting of the treatment location.
- In another case, the interventional procedure comprises a balloon angioplasty procedure at the treatment location.
- According to another aspect the invention provides a method for the capture and removal of embolic material from a vasculature during an interventional procedure comprising the steps of:—
-
- advancing a guidewire through a vasculature;
- crossing a desired treatment location with the guidewire;
- introducing over the guidewire a collapsible embolic protection filter having a collapsed configuration for delivery of the filter, and a deployed configuration;
- deploying the filter distal to the treatment location;
- the filter in the deployed configuration being retained in apposition with the vasculature independent of the guidewire against substantial longitudinal movement;
- carrying out an interventional procedure at the treatment location, embolic material generated during the treatment procedure being captured by the deployed filter;
- advancing a retrieval device;
- engaging the filter with the retrieval device; and
- withdrawing the retrieval device and the filter from the vasculature.
- In one case, on the filter applies a radial force to the vasculature to substantially prevent movement of the filter relative to the vasculature in the deployed configuration.
- Preferably the filter in the deployed configuration is anchored to the vasculature.
- In one case, the filter is engaged with the retrieval device independent of the guidewire.
- According to another aspect the method comprises the step of releasing the filter from the vasculature before retrieving the filter.
- According to a further aspect, the retrieval device is a retrieval catheter and the filter is simultaneously released and retrieved by moving the retrieval catheter distally relative to the filter.
- In one case, the filter is released prior to retrieving the filter.
- According to one aspect, the method comprises the step of axially elongating the filter to release of the filter.
- Preferably the method comprises the steps of:—
-
- withdrawing the guidewire from the filter and the desired treatment location; and
- subsequently placing a guidewire in the filter.
- According to a one aspect, the same guidewire is placed in the filter. According to a another aspect, another guidewire is placed in the filter.
- In one case, the interventional device is introduced over the guidewire for carrying out the interventional procedure.
- Preferably the interventional procedure comprises a stenting of the treatment location.
- According to one aspect, the interventional procedure comprises a balloon angioplasty procedure at the treatment location.
- According to a further aspect a method for the capture and removal of embolic material from a vasculature during an interventional procedure comprising the steps of:—
-
- providing a collapsible embolic protection filter having a collapsed configuration for delivery of the filter, and a deployed configuration;
- advancing a guidewire through a vasculature;
- crossing a desired treatment location with the guidewire;
- deploying the filter distal to the treatment location;
- withdrawing the guidewire from the filter and/or the desired treatment location; and
- subsequently placing a guidewire in the filter;
- carrying out an interventional procedure at the treatment location, embolic material generated during the treatment procedure being captured by the deployed filter;
- advancing a retrieval device;
- engaging the filter with the retrieval device; and
- withdrawing the retrieval device and the filter from the vasculature.
- In one case, the same guidewire is placed in the filter.
- In another case, another guidewire is placed in the filter.
- In one case the interventional device is introduced over the guidewire for carrying out the interventional procedure.
- In another case, the interventional procedure comprises a stenting of the treatment location.
- In one case, the interventional procedure comprises a balloon angioplasty procedure at the treatment location.
- In one case, the filter is engaged with the retrieval device independent of the guidewire.
- In another case, after crossing a treatment location with the guidewire the embolic protection device is introduced over the guidewire.
- Preferably the deployed filter is retained independent of the guidewire against substantial longitudinal movement.
- In one case, on deployment, the filter applies a radial force to the vasculature to substantially prevent movement of the filter relative to the vasculature in the deployed configuration.
- In one case, the filter in the deployed configuration is anchored to the vasculature.
- In one case, the method comprises the step of releasing the filter from the vasculature before retrieving the filter.
- In another case, the filter is simultaneously released and retrieved by moving a retrieval catheter distally relative to the filter.
- In another case, the filter is released prior to retrieving the filter. According to one aspect, the method comprises the step of axially elongating the filter to release the filter.
- According to a further aspect the invention provides a method of retrieving a medical device from a vasculature, the method comprising the steps of:—
-
- advancing a retrieval catheter through a vasculature until a distal end of the retrieval catheter is proximally of the deployed medical device;
- axially elongating an element of the medical device to collapse the medical device; and
- moving the retrieval catheter distally relative to the collapsed medical device to retrieve the medical device into the retrieval catheter.
- In one case, the method comprises the steps of:—
- engaging a first coupling member with the element of the deployed medical device;
- engaging a second coupling member with the element of the deployed medical device; and
- moving the coupling members relative to one another to axially elongate the element of the medical device.
- According to another aspect of the invention, there is provided an embolic protection filter for deployment in a vasculature, the filter having an inlet end and an outlet end, the inlet end having one or more inlet openings sized to allow blood and embolic material enter the filter, and the outlet end of the filter having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter;
-
- the filter being movable between a collapsed configuration for movement through a vasculature, and an outwardly extended configuration for deployment in a vasculature;
- the filter at least in the collapsed configuration having a guidewire lumen defined at least partially therethrough for passing the filter over a guidewire;
- wherein the tubular member is shortenable upon movement of the filter from the collapsed configuration to the extended configuration.
- In one embodiment, the tubular member comprises at least two telescopable tubes.
- According to another aspect of the invention, there is provided an embolic protection filter for deployment in a vasculature, the filter having an inlet end and an outlet end, the inlet end having one or more inlet openings sized to allow blood and embolic material enter the filter, and the outlet end of the filter having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter;
-
- the filter being movable between a collapsed configuration for movement through a vasculature, and an outwardly extended configuration for deployment in a vasculature;
- the filter at least in the collapsed configuration having a guidewire lumen defined at least partially therethrough for passing the filter over a guidewire; wherein the filter comprises a support structure, in the collapsed configuration the support structure forming a tubular member to define the guidewire lumen.
- According to another aspect the invention provides a method for the capture and removal of embolic material from a vasculature during an interventional procedure comprising the steps of:—
-
- advancing a guidewire through a vasculature;
- crossing a desired treatment location with the guidewire;
- introducing over the guidewire a collapsible embolic protection filter having a collapsed configuration for delivery and withdrawal of the filter, and a deployed configuration;
- deploying the filter distal to the treatment location;
- carrying out an interventional procedure at the treatment location, embolic material generated during the treatment procedure being captured by the deployed filter;
- advancing a retrieval catheter;
- fixing an abutment to the guidewire;
- engaging the guidewire abutment with the filter to prevent movement of the filter distally of the guidewire abutment;
- collapsing the filter and retrieving the filter into the retrieval catheter and with it the captured embolic material; and
- withdrawing the retrieval catheter and the collapsed filter from the vasculature.
- In one case, the abutment is fixed to the guidewire during deployment of the filter.
- In another case, the abutment is fixed to the guidewire before advancing the guidewire through the vasculature.
- According to another aspect of the invention there is provided a retrieval catheter for retrieving a medical device deployed in a vasculature, the catheter comprising:—
-
- a first coupling member having means for coupling to a medical device deployed in a vasculature; and
- a second coupling member having means for coupling to the deployed medical device;
- the coupling members being relatively movable to axially elongate the medical device and collapse the medical device.
- In one embodiment, the catheter comprises an outer catheter body movable distally relative to the coupling members to retrieve a collapsed medical device into the catheter body.
- According to another aspect of the invention, there is provided an embolic protection filter for deployment in a vasculature, the filter having an inlet end and an outlet end, the inlet end having one or more inlet openings sized to allow blood and embolic material enter the filter, and the outlet end of the filter having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter; and
-
- the filter comprising an inflatable member to exert an outward radial force on a vasculature wall sufficient to retain the filter in position against substantial longitudinal movement.
- According to a further aspect of the invention there is provided an embolic protection filter system comprising:—
- a collapsible embolic protection filter having a collapsed configuration for delivery of the filter, and a deployed configuration; and
- a snare for engaging the filter.
- In one embodiment, the filter has a snare engaging feature for engagement by the snare.
- In one embodiment, the filter comprises a support frame and the snare engaging feature is provided by or on the support frame.
- Preferably the snare is radiopaque at least in a region of engagement with a filter.
- In one embodiment, the snare engaging feature is radiopaque.
- In another embodiment, the snare comprises a snaring hoop.
- According to a further aspect the invention provides a method for the capture and removal of embolic material from a vasculature during an interventional procedure comprising the steps of:—
-
- providing a collapsible embolic protection filter having a collapsed configuration for delivery of the filter, and a deployed configuration;
- advancing a guidewire through a vasculature;
- crossing a desired treatment location with the guidewire;
- deploying the filter distal to the treatment location;
- carrying out an interventional procedure at the treatment location, embolic material generated during the treatment procedure being captured by the deployed filter;
- advancing a snare;
- engaging the snare with the filter; and
- withdrawing the snare and the filter.
- In one case, the filter has a snare engaging feature and the snare is engaged with the snare engaging feature.
- In another case, the snare engaging feature is provided on or by a support frame of the filter.
- In one case, the method comprises the steps of leading the snare into engagement with the snare engaging feature of the filter and monitoring the engagement of the filter with the snare.
- In one case, the snare and/or snare engaging features are radiopaque for external monitoring of the engagement.
- In one case, the snare is engaged with the filter independent of the guidewire. In another case, after crossing a treatment location with the guidewire the embolic protection device is introduced over the guidewire.
- According to the invention, there is provided a method for the capture and removal of embolic material from a vasculature during an interventional procedure comprising the steps of:—
-
- advancing a guidewire through a vasculature;
- crossing a desired treatment location with the guidewire;
- introducing over the guidewire a collapsible embolic protection filter having a collapsed configuration for delivery and withdrawal of the filter, and a deployed configuration;
- deploying the filter distal to the treatment location;
- the filter in the deployed configuration being in apposition with the vasculature so that the filter is retained in position against substantial longitudinal movement, on deployment in the vasculature;
- carrying out an interventional procedure at the treatment location, embolic material generated during the treatment procedure being captured by the deployed filter;
- advancing a retrieval catheter;
- collapsing the filter and retrieving the filter at least partially into the retrieval catheter and with it the captured embolic material; and
- withdrawing the retrieval catheter and the collapsed filter from the vasculature.
- In one embodiment of the invention the method comprises the step of releasing the apposition of the filter with the vasculature before collapsing the filter.
- The filter may be simultaneously collapsed and retrieved into the retrieval catheter by moving the retrieval catheter distally relative to the filter.
- Alternatively the filter may be collapsed prior to retrieving the filter into the retrieval catheter. Preferably the method comprises the step of axially elongating the filter to collapse the filter.
- Desirably the method comprises the step of engaging a part of the retrieval catheter with the filter to aid collapsing of the filter.
- In one case the method comprises the steps of:—
-
- withdrawing the guidewire from the filter and the desired treatment location; and
- crossing the desired treatment location with another guidewire.
- The interventional device may be introduced over the other guidewire for carrying out the interventional procedure.
- In one case the interventional procedure comprises a stenting of the treatment location. In another case the interventional procedure comprises a balloon angioplasty procedure at the treatment location.
- In another aspect the invention provides a method for the capture and removal of embolic material from a vasculature during an interventional procedure comprising the steps of:—
-
- advancing a guidewire through a vasculature;
- crossing a desired treatment location with the guidewire;
- introducing over the guidewire a collapsible embolic protection filter having a collapsed configuration for delivery and withdrawal of the filter, and a deployed configuration;
- deploying the filter distal to the treatment location;
- carrying out an interventional procedure at the treatment location embolic material generated during the treatment procedure being captured by the deployed filter;
- advancing a retrieval catheter;
- fixing an abutment to the guidewire;
- engaging the guidewire abutment with the filter to prevent movement of the filter distally of the guidewire abutment;
- collapsing the filter and retrieving the filter into the retrieval catheter and with it the captured embolic material; and
- withdrawing the retrieval catheter and the collapsed filter from the vasculature.
- The abutment may be fixed to the guidewire during deployment of the filter. Alternatively the abutment may be fixed to the guidewire before advancing the guidewire through the vasculature.
- In a further aspect of the invention, there is provided a retrieval catheter for retrieving a medical device deployed in a vasculature, the catheter comprising:—
-
- an outer catheter body; and
- an inner coupling member having means for coupling to a medical device deployed in a vasculature;
- the catheter body being movable distally relative to the coupling member to retrieve a coupled medical device into the catheter body.
- In one embodiment of the invention the coupling means comprises a male or female member on the coupling member for engagement with a corresponding female or male member on the medical device.
- In a preferred case the male member is movable between a low-profile configuration and an outwardly protruding configuration. Ideally the male member is biased towards the outwardly protruding configuration. Most preferably the male member is of a resilient material.
- In one case the coupling means is substantially arrow-head shaped.
- In another case the male member is in the form of a hook for hooking around a female member on the medical device. Alternatively the male member may be in the form of a hook for hooking around a tether arm on the medical device. Ideally the tether arm is at a proximal end of the medical device. The tether arm may be located within the medical device.
- In another embodiment of the invention the coupling means comprises at least one female member on the coupling member for engagement with at least one male member on the medical device. The female member may be in the form of a loop for looping around a protruding male member on the medical device.
- In a preferred embodiment the coupling means comprises a pair of jaws on the coupling member, the jaws being movable between an outwardly protruding configuration and a low-profile configuration to grasp the medical device. The retrieval catheter may comprise an actuator to move the jaws to the outwardly protruding configuration. Ideally the actuator is movable longitudinally relative to the jaws to move the jaws in a camming arrangement to the outwardly protruding configuration. Most preferably the jaws are biased towards the low-profile configuration.
- In another embodiment the catheter body is engageable with the jaws to move the jaws to the low-profile configuration. The jaws may be biased towards the outwardly protruding configuration.
- In another embodiment of the invention the coupling means comprises an inflatable member on the coupling member for engagement with the medical device. Preferably the inflatable member is movable inwardly upon inflation to engage the medical device. The coupling means may comprise an engagement surface on the coupling member for engagement with an inflatable member on the medical device.
- In a further embodiment the coupling member is at least partially of a magnetic material for magnetic coupling to an oppositely charged magnetic portion of the medical device.
- The retrieval catheter may comprise means to axially elongate a deployed medical device to collapse the medical device to a low-profile configuration for retrieval into the catheter body. Preferably the elongation means comprises a second coupling member movable relative to the first coupling member to collapse the medical device. Ideally the second coupling member comprises a pusher member movable distally relative to first coupling member to engage a deployed medical device distally of the first coupling means and thereby collapse the medical device.
- In one case the catheter body has a guidewire lumen extending partially therethrough for passing the catheter body over a guidewire in a rapid exchange manner. The guidewire lumen may be offset radially from the coupling member.
- The retrieval catheter of the invention may be for retrieving an embolic protection filter deployed in a vasculature.
- According to another aspect of the invention, there is provided a retrieval catheter for retrieving a medical device deployed in a vasculature, the catheter comprising:—
-
- a first coupling member having means for coupling to a medical device deployed in a vasculature; and
- a second coupling member having means for coupling to the deployed medical device;
- the coupling members being relatively movable to axially elongate the medical device and collapse the medical device.
- In one embodiment the catheter comprises an outer catheter body movable distally relative to the coupling members to retrieve a collapsed medical device into the catheter body.
- In another aspect, the invention provides a method of retrieving a medical device from a vasculature, the method comprising the steps of:—
-
- advancing a retrieval catheter through a vasculature until a distal end of the retrieval catheter is proximally of the deployed medical device;
- axially elongating an element of the medical device to collapse the medical device; and
- moving the retrieval catheter distally relative to the collapsed medical device to retrieve the medical device into the retrieval catheter.
- In one embodiment the method comprises the steps of:—engaging a first coupling member with the element of the deployed medical device;
-
- engaging a second coupling member with the element of the deployed medical device; and
- moving the coupling members relative to one another to axially elongate the element of the medical device.
- The invention also provides in another aspect an embolic protection filter for deployment in a vasculature, the filter having an inlet end and an outlet end, the inlet end having one or more inlet openings sized to allow blood and embolic material enter the filter, and the outlet end of the filter having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter;
- the filter being movable between a collapsed configuration for movement through a vasculature, and an outwardly extended configuration for deployment in a vasculature in apposition with a vasculature wall;
- in the outwardly extended configuration the filter exerting an outward radial force on a vasculature wall sufficient to retain the filter in position against substantial longitudinal movement.
- In one embodiment of the invention the filter comprises a filter body and a filter support frame to support the filter body in the outwardly extended configuration in apposition with a vasculature wall, the filter support frame providing the outward radial force.
- The filter may comprise a low-friction outer layer. Preferably the outer layer is of a hydrophilic material.
- In one case the filter comprises an inflatable member to enhance the outward radial force.
- Ideally the filter defines a guidewire lumen for passing the filter over a guidewire.
- According to another aspect of the invention, there is provided an embolic protection filter for deployment in a vasculature, the filter having an inlet end and an outlet end, the inlet end having one or more inlet openings sized to allow blood and embolic material enter the filter, and the outlet end of the filter having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter; and
- the filter comprising a central tether extending proximally of the filter.
- Ideally the tether is a generally central tether.
- The tether may comprise a wire, preferably the wire is configured to facilitate passage of a medical device over the wire.
- The invention also provides in a further aspect, an embolic protection filter for deployment in a vasculature, the filter having an inlet end and an outlet end, the inlet end having one or more inlet openings sized to allow blood and embolic material enter the filter, and the outlet end of the filter having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter; and
- the filter comprising an inflatable member to exert an outward radial force on a vasculature wall sufficient to retain the filter in position against substantial longitudinal movement.
- In another aspect, the invention provides a method for the capture and removal of embolic material from a vasculature during an interventional procedure comprising the steps of:—
-
- advancing a first guidewire through a vasculature;
- crossing a desired treatment location with the first guidewire;
- introducing over the first guidewire a collapsible embolic protection filter having a collapsed configuration for delivery and withdrawal of the filter, and a deployed configuration;
- deploying the filter distal to the treatment location;
- withdrawing the first guidewire from the filter and the desired treatment location;
- crossing the desired treatment location with a second guidewire;
- introducing over the second guidewire an interventional device,
- carrying out an interventional procedure at the treatment location, embolic material generated during the treatment procedure being captured by the deployed filter;
- advancing a retrieval catheter;
- collapsing the filter and retrieving the filter into the retrieval catheter and with it the captured embolic material; and
- withdrawing the retrieval catheter and the collapsed filter from the vasculature.
- In one embodiment of the invention the method comprises the step of leading the second guidewire through the filter prior to carrying out the interventional procedure. The method may comprise the step of guiding the second guidewire through the filter. Ideally the second guidewire remains proximal of the deployed filter.
- In another embodiment the method comprises the steps of:—
-
- withdrawing the second guidewire from the filter and the desired treatment location;
- advancing a third guidewire to the filter; and
- advancing the retrieval catheter over the third guidewire.
- In one case collapsing the filter into the retrieval catheter comprises the step of releasing the filter from apposition with the vasculature wall.
- The diameters of the guidewires may differ. The material properties of the guidewires may differ.
- The invention provides in a further aspect an embolic protection filter assembly for deployment in a vasculature, the assembly comprising:—
-
- a filter having an inlet end and an outlet end, the inlet end having one or more inlet openings sized to allow blood and embolic material enter the filter, and the outlet end of the filter having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter; and
- a receiver to guide a docking device into association with the filter.
- In one embodiment the filter has a guidewire lumen for passing the filter over a guidewire, and the receiver is configured to guide a guidewire into the guidewire lumen. The guidewire lumen may extend only partially through the filter. Preferably the receiver is configured to guide a coupling member towards the filter for coupling to the filter.
- In one case the receiver comprises a funnel. Preferably the funnel is movable between a collapsed configuration for movement through a vasculature, and an outwardly extended configuration for guiding a docking device. Ideally the funnel is biased towards the outwardly extended configuration.
- In one embodiment the funnel comprises a funnel body and a funnel support to support the funnel body in the outwardly extended configuration. Preferably the funnel body comprises a membrane. Ideally the funnel support comprises a plurality of pivotable fingers.
- In another embodiment the receiver comprises an approach channel. Preferably the channel is provided by a lumen in a catheter.
- The receiver may be mounted to the filter. Preferably the receiver is detachably mounted to the filter.
- Alternatively the receiver may be separate from the filter.
- In a preferred embodiment the receiver has means to space the receiver from the wall of a vasculature. Ideally the spacing means comprises an inflatable member to engage the wall of a vasculature.
- In one embodiment the receiver is at least partially provided by a wall of the filter. Preferably the receiver is at least partially provided by a wall of the filter at the inlet end of the filter. Alternatively the receiver may be at least partially provided by a wall of the filter at the outlet end of the filter.
- In one case the receiver extends proximally of the inlet end of the filter. In another case the receiver is located distally of the inlet end of the filter.
- In a further embodiment the receiver is radially offset from the longitudinal axis of the filter.
- According to a further aspect of the invention, there is provided an embolic protection system comprising:—
-
- an embolic protection filter assembly of the invention; and
- a docking device which may be guided by the receiver into association with the filter.
- In one embodiment the docking device comprises a guidewire.
- In another case the docking device comprises a coupling member.
- In another aspect, the invention provides an embolic protection filter having an inlet end and an outlet end, the inlet end having one or more inlet openings sized to allow blood and embolic material enter the filter, and the outlet end of the filter having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter;
- the filter having a guidewire aperture for passing the filter over a guidewire; and
- the filter comprising a seal to seal the guidewire aperture.
- The seal may be self-closing.
- Ideally the seal is located at a proximal end of the filter, and/or at a distal end of the filter.
- The filter may have a tubular member extending from the guidewire aperture to define a guidewire lumen through the tubular member. In one case the tubular member extends through at least part of the filter. Preferably the tubular member is radially offset from the longitudinal axis of the filter.
- In one embodiment the seal is an annular member around the guidewire aperture, the annular member being closable down to seal the guidewire aperture. In one case the annular member is a tube. In another case the annular member comprises a soft membrane. The annular member may comprise two or more circumferentially overlapping flaps.
- The invention provides in another aspect an embolic protection filter for deployment in a vasculature, the filter having an inlet end and an outlet end, the inlet end having one or more inlet openings sized to allow blood and embolic material enter the filter, and the outlet end of the filter having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter;
- the filter being movable between a collapsed configuration for movement through a vasculature, and an outwardly extended configuration for deployment in a vasculature;
- the filter at least in the collapsed configuration having a guidewire lumen defined at least partially therethrough for passing the filter over a guidewire.
- The guidewire lumen may be defined by a tubular member extending at least partially through the filter.
- In one case the tubular member is mounted to the filter. In another case the tubular member is spaced proximally of a distal end of the filter.
- Preferably the tubular member is shortenable upon movement of the filter from the collapsed configuration to the extended configuration. Ideally the tubular member comprises at least two telescopable tubes.
- In one embodiment the tubular member is provided by a catheter.
- The catheter may be a retrieval catheter, or a delivery catheter.
- In another embodiment of the invention the filter comprises a support structure, in the collapsed configuration the support structure forming a tubular member to define the guidewire lumen.
- The invention will be more clearly understood from the following description of some embodiments thereof, given by way of example only, with reference to the accompanying drawings, in which:—
-
FIG. 1 is a perspective of an embolic protection filter according to the invention; - FIGS. 2 to 16 are partially cross-sectional, side views illustrating the use of an embolic protection filter;
-
FIG. 17 is a perspective view of another filter of the invention; -
FIG. 18 is a side view of a further filter of the invention; -
FIG. 19 is an end view of the filter ofFIG. 18 ; -
FIG. 20 is a side view of another filter of the invention; -
FIGS. 21 and 22 are side views of another filter, in use; - FIGS. 23 to 26 are diagrams illustrating a filter of the invention, in use;
- FIGS. 27 to 31 are perspective views of various alternative constructions of filters;
- FIGS. 32 to 39 are various views of a delivery catheter which may be used in the invention;
- FIGS. 40 to 54 are side, partially cross sectional views illustrating various steps in the method of the invention;
- FIGS. 55 to 57 are various views of another delivery catheter which may be used in the invention;
- FIGS. 58 to 61 are views illustrating the use of a temporary lumen-defining member for filter delivery;
- FIGS. 62 to 68 are views illustrating the use of a part of the delivery system to provide a temporary lumen-defining member;
-
FIGS. 69 and 70 are perspective views of such a lumen-defining member extending to a side of a filter; -
FIGS. 71 and 72 are perspective views of such a lumen-defining member extending through a filter; -
FIG. 73 is a schematic view of another embolic protection filter according to the invention in a deployed configuration; -
FIG. 74 is a schematic view of the filter ofFIG. 73 collapsed in a delivery catheter; -
FIG. 75 is a perspective view of another embolic protection filter according to the invention; -
FIG. 76 is a cross-sectional, side view of a delivery catheter according to the invention in a delivery configuration; -
FIG. 77 is a cross-sectional, side view of the filter ofFIG. 75 collapsed in the delivery catheter ofFIG. 87 ; -
FIG. 78 is a cross-sectional, side view of the delivery catheter ofFIG. 76 in a deployment configuration; -
FIGS. 79 and 80 are views of a filter with a guidewire passageway at the side thereof; -
FIG. 81 is an enlarged view of a detail ofFIG. 80 ; - FIGS. 82 to 84 are perspective views illustrating different guidewire paths;
-
FIG. 85 is a perspective view of another embolic protection filter according to the invention; -
FIG. 86 is an enlarged, perspective view of a receiver of the embolic protection filter ofFIG. 85 ; - FIGS. 87 to 89 are partially cross-sectional, side views illustrating guiding of a guidewire through the embolic protection filter of
FIG. 85 ; -
FIG. 90 is a partially cross-sectional, side view of the embolic protection filter ofFIG. 85 deployed in a vasculature; -
FIGS. 91 and 92 are enlarged, perspective views of seals of the embolic protection filter ofFIG. 90 ; - FIGS. 93 to 110 are partially cross-sectional, side views of the embolic protection filter of
FIG. 85 in use; -
FIG. 111 is a side view of another retrieval catheter according to the invention passing over a guidewire; -
FIG. 112 is a view along line B-B inFIG. 111 ; -
FIGS. 113 and 114 are partially cross-sectional, side views illustrating retrieval of the filter ofFIG. 1 using the retrieval catheter ofFIG. 51 (a); -
FIG. 115 is a perspective view of another embolic protection filter according to the invention; -
FIGS. 116 and 117 are perspective and cross-sectional, side views respectively of another embolic protection filter according to the invention; -
FIG. 118 is a perspective view of a further embolic protection filter according to the invention guiding a guidewire through the embolic protection filter; -
FIGS. 119 and 120 are partially cross-sectional, side views of the embolic protection filter ofFIG. 118 guiding a guidewire through the embolic protection filter; -
FIG. 121 is an end view of the embolic protection filter ofFIG. 118 ; -
FIG. 122 is a side view of a distal end of a filter; - FIGS. 123 to 126 are end views in the direction of the arrow X of
FIG. 122 of various outlet seals; -
FIG. 127 is a perspective view of the filter of FIGS. 122 to 126, in use; - FIGS. 128 to 132 are various views of a filter with an alternative outlet seal;
-
FIG. 133 is a perspective view of an alternative outlet seal; -
FIGS. 134 and 135 are cross-sectional views of the seal ofFIG. 133 , in use; -
FIGS. 136 and 137 are perspective views of further outlet seals; -
FIG. 138 is a perspective view of a further outlet seal; -
FIGS. 139 and 140 are cross-sectional views on the line A-A ofFIG. 138 in different configurations of use; - FIGS. 141 to 143 are views of a further outlet seal arrangement;
- FIGS. 144 to 149 are partially cross-sectional side views illustrating retrieval of an embolic protection device;
- FIGS. 150 to 163 are partially cross-sectional, side views of an embolic protection filter and a retrieval catheter in use;
- FIGS. 164 to 165 are partially cross-sectional, side views illustrating retrieval of another embolic protection filter according to the invention;
-
FIGS. 166 and 167 are schematic side views illustrating retrieval of an embolic protection filter using other retrieval catheters according to the invention; -
FIG. 168 is a perspective view of another embolic protection filter according to the invention; -
FIG. 169 is a perspective view illustrating retrieval of the filter ofFIG. 168 ; -
FIG. 170 is a perspective view of another embolic protection filter according to the invention; -
FIG. 171 is a perspective view illustrating retrieval of the filter ofFIG. 170 ; -
FIGS. 172 and 173 are perspective views of further embolic protection filters according to the invention; - FIGS. 174 to 178 are schematic views illustrating retrieval of the embolic protection filter of
FIG. 168 ; -
FIGS. 179 and 180 are perspective views of further embolic protection filters according to the invention; -
FIGS. 181 and 182 are perspective views illustrating retrieval of another embolic protection filter according to the invention; -
FIG. 183 is a perspective view of another embolic protection filter deployed in a vasculature; -
FIG. 184 is a side view of part of another retrieval catheter according to the invention; -
FIG. 185 is a cross-sectional, side view of the retrieval catheter ofFIG. 184 ; - FIGS. 186 to 188 are schematic side views illustrating retrieval of an embolic protection filter using the retrieval catheter of
FIG. 184 ; -
FIG. 189 is a side view along line A-A inFIG. 188 ; - FIGS. 190 to 192 are cross-sectional side views illustrating retrieval of an embolic protection filter using another retrieval catheter of the invention;
-
FIG. 193 is a cross-sectional, side view of part of another retrieval catheter according to the invention; -
FIG. 194 is a partially cross-sectional, side view illustrating collapse of an embolic protection filter using the retrieval catheter ofFIG. 193 ; - FIGS. 195 to 201 are various views illustrating the snaring of an embolic protection device of the invention;
- FIGS. 201 to 206 are various views illustrating snaring of another filter;
- FIGS. 207 to 212 are various views illustrating snaring of a further filter;
- FIGS. 213 to 218 are views illustrating another retrieval system;
- FIGS. 219 to 234 are views of the snaring of a filter of the invention;
-
FIGS. 225 and 226 are views of another filter of the invention; - FIGS. 227 to 230 illustrate retrieval of filters;
-
FIGS. 231 and 232 illustrate snaring of another filter; - FIGS. 233 to 237 are side, partially cross-sectional views of the snaring of any filter;
-
FIGS. 238 and 239 illustrate the snaring of another filter; -
FIG. 240 is a partially cross-sectional, side view of an embolic protection filter according to the invention in an expanded configuration; -
FIG. 241 is a partially cross-sectional, side view of the filter ofFIG. 240 in a collapsed configuration; -
FIGS. 242 and 243 are partially cross-sectional, side views illustrating retrieval of the filter ofFIG. 240 ; -
FIG. 244 is a partially cross-sectional, side view of the filter ofFIG. 240 after being recrossed with a guidewire; -
FIGS. 245 and 246 are partially cross-sectional, side views illustrating retrieval of the filter ofFIG. 244 . - FIGS. 247 to 251 are views similar to
FIGS. 90, 91 , and 94 to 96 respectively of another embolic protection filter according to the invention; -
FIG. 252 is a schematic view illustrating fixing of an abutment to a guidewire; - [253 to 255 are not used]
-
FIG. 256 is a schematic view of the guidewire and the abutment; -
FIG. 257 is a perspective view of another embolic protection filter according to the invention passing over a guidewire; - FIGS. 258 to 260 are partially cross-sectional side views illustrating guiding of a guidewire through an embolic protection filter;
-
FIG. 261 is a cross-sectional, end view of a catheter according to the invention; -
FIG. 262 is a cross-sectional, end view of a catheter according to the invention; -
FIG. 263 is a cross-sectional, side view of another retrieval catheter according to the invention; and -
FIG. 264 is a partially cross-sectional, side view illustrating retrieval of an embolic protection filter using the retrieval catheter ofFIG. 263 . - The invention provides an embolic protection system which has a number of features which allows the system to be used in placing a guide catheter proximal to lesion as per standard practice and advance any suitable guidewire across the lesion. A load filter is loaded into the delivery catheter in such a way as to provide a lumen through the loaded device through which the guidewire will pass. The loaded device is advanced over the guidewire and across the lesion. The filter is deployed from the delivery catheter and the delivery catheter is removed. The filter remains stable in the vessel without any user control. Standard interventional procedures (angioplasty, stent etc . . . ) can be performed. The guidewire may be replaced by simply removing the initial wire and advancing a replacement wire through the guide catheter, across the lesion and through the filter. The filter may be retrieved by advancing a retrieval catheter over the guidewire and up to the filter. An inner member of the retrieval catheter may be engaged with the filter. Then outer retrieval sheath is advanced to collapse the filter and retrieve. The guidewire may be left in place if desired.
- Referring to the drawings and initially to
FIG. 1 there is illustrated anembolic protection filter 1 according to the invention, thefilter 1 being suitable for deployment in a vasculature to filter undesired embolic material from the blood stream flowing through the vasculature. - The
filter 1 comprises acollapsible filter body 2 which in this case is supported by a collapsiblefilter support frame 3. In this case the filter support is mounted on aninner tube 8. - The
filter body 2 has aninlet end 4 and anoutlet end 5. Theinlet end 4 has one or more, and in this a single,large inlet opening 6 which are sized to allow blood and embolic material enter thefilter body 2. Theoutlet end 5 has a plurality ofsmall outlet openings 7 which are sized to allow through passage of blood but to retain undesired embolic material within thefilter body 2. In this way, thefilter 1 captures and safely retains any undesired embolic material in the blood stream within thefilter body 2 while facilitating continued flow of blood through the vascular system. Emboli are thus prevented from flowing further downstream through the vascular system, which could otherwise have potentially catastrophic results. - The relatively
large inlet opening 6 provide for the possibility of aspirating embolic material from within thefilter body 2. This may be particularly advantageous if it is desired to leave thefilter 1 in place in a vasculature for a long period of time, for example overnight, to assist in vascular recovery. - The
filter body 2 may have a low-friction outer layer, for example a hydrophilic coating, to minimise frictional resistance during deployment and retrieval of thefilter 1, and thefilter body 2 may be of an oriented polymeric material, as described in International patent application No. PCT/IE01/00087, the relevant contents of which are incorporated herein by reference. - The
inner tube 8 has aguidewire lumen 12 therethrough for passing thefilter 1 over aguidewire 10. Aguidewire 10 can pass through the filter however, in the deployed configuration the filter is independent of the guidewire. Thus, the guidewire can be moved independently of the filter without any associated movement of the filter. The arrangement allows relatively large radial forces to be exerted on the vascular wall without the risk of abrasion causes by movement of the deployed filter. In this way damage to the endothelium can be avoided. - The
filter 1 is movable between a low-profile, collapsed configuration for movement through the vasculature, and an outwardly extended configuration for deployment in the vasculature in apposition with the vasculature wall. - In the outwardly extended configuration, the
filter body 2 is supported in an expanded position by thefilter support 3 so as to maximise the internal volume of thefilter body 2 to capture and safely retain as much embolic material as possible. - The
filter support 3 supports thefilter body 2 in the outwardly extended configuration in apposition with the vasculature wall to prevent blood flow bypassing thefilter 1 between thefilter body 2 and the vasculature wall. - The support frame in this case defines a
proximal support hoop 15 which is connected to thetubular member 8 by asupport arm 16. Thesupport 3 in this case also comprises a number of axially extendingportions 17 which assist in providing body support to the filter in a vessel and assist in preventing rotation of the filter when deployed in the deployed configuration. The support may be of wire and may also comprise one or more stabilising hoops(s) 18. - In this case the
tubular member 8 terminates proximally of thedistal end 5 of the filter. This has a number of advantages. It facilitates recrossing of thefilter 1 with a guidewire and the distal free end of thetubular member 8 may be readily snared for snaring and/or retrieval of the filter when it is desired to remove the filter from the vasculature. - In the outwardly extended configuration, the
filter support 3 exerts an outward radial force on thefilter body 2 and the vasculature wall which results in a frictional force between thefilter body 2 and the vasculature wall sufficient to retain thefilter 1 in position against substantial longitudinal movement. - In the invention the filter will not rotate or collapse in the absence of guidewire support. Conventional filters are coupled (directly or indirectly) to a wire—this wire enhances the stability of the filter. This invention describes a filter which will remain fully open and opposed to the vessel wall in the absence of any support from a guidewire. This is achieved by using a support frame which does not allow rotation in the vessel lumen. In general, a frame which lies in only one plane cannot remain apposed to the vessel wall without support from the guidewire. The design of the system is such that the filter must do considerable work to move longitudinally.
- In order to ensure that the filter is retained in position the filter apposition force generates a frictional force between the filter and the vessel. The frictional force generated by the filter is dependent on the contact area, the apposition force generated by the filter and the coefficient of static friction between the filter and the vessel. Locating the filter using frictional forces alone is a worst-case analysis as it does not include the effect of tapered vessels. These will increase the apposition force generated by the filter as it moves distally into a lumen of decreasing diameter.
- The radial apposition force of the
filter support 3 is sufficient to retain the deployedfilter 1 in position in the vasculature against substantial longitudinal movement, even if the guidewire, over which thefilter 1 is delivered, is moved. No step, abutment or other stop means is required on the guidewire to prevent thefilter 1 from migrating downstream in the vasculature. In this manner, the invention enables an interventional procedure to be performed using a standard guidewire. This enhances clinician freedom by enabling a clinician to choose the most appropriate medical guidewire for a particular interventional procedure, and/or a particular patient anatomy. - In the case of a filter which has an integral tubular member the tubular member defines a lumen through which a guidewire can pass. In the invention such a guidewire passageway may be provided by a component of the delivery system such as a portion of a deployment pusher. Alternatively, the tubular member may be a separate component which is removed after the guidewire has passed through the filter. Thus, the member defining a guidewire pathway through the filter may be a movable or removable component.
- Referring to FIGS. 2 to 16 there are illustrated various steps in the use of an embolic protection device during an interventional procedure. Various steps in the method will be described and it will be appreciated that the various steps and the features of the various apparatus used in the method may be used independently of one another, for example in the methods and apparatus of other aspects of the invention.
- The filter does not necessarily itself have a predetermined lumen for passage of a guidewire. At various stages a lumen is defined when such a lumen is required. On loading of a
filter 20 into a delivery catheter 21 a guidewire lumen is defined (FIG. 2 ) which is used for delivery of thefilter 20 over a pre-positioned guidewire 10 (FIG. 3 ). The lumen-definingmember 22 may be removed (FIG. 3 ) and the filter is advanced to and deployed distal to a treatment location in the vasculature (FIGS. 4 and 5 ). Various procedures may be carried out such as balloon angioplasty and stenting (FIGS. 6 and 7 ). The filter may be retrieved into a retrieval catheter 25 (FIGS. 11 to 15) and the filter removed. - In this case the
filter 20 comprises a filter body supported in the deployed configuration by asupport frame 3 defining a largeproximal opening 6 and having, a snaring engaging element in the form of ahook 26. In use, the filter is loaded into a delivery catheter L6 by inserting atubular element 22 through the filter. The delivery catheter may be threaded onto a pre-deployedbare guidewire 10, thetubular element 22 guiding theguidewire 10 through thefilter 20 at the distal end of thedelivery catheter 21. Once theguidewire 10 has entered thedelivery catheter 21 proximal to thefilter 20 thetubular element 22 may be removed. To facilitate this, the tubular element may be of C-shape in transverse cross section. Thedelivery catheter 21 is then advanced over theguidewire 10 to a location which is distal of a treatment site. Thefilter 20 is deployed by pushing it out from the distal end of the delivery catheter, for example by using a pusher. The filter is then in the deployed open configuration distal to a treatment location (FIG. 5 ). Various procedures may be carried out at the treatment location, and embolic material released during the treatment procedures being captured in the filter. The treatment procedures may include deployment of astent 29 from a stent delivery catheter threaded over theguidewire 10. When it is desired to retrieve the filter aretrieval catheter 25 is delivered over theguidewire 10. Theretrieval catheter 25 may be a snare catheter or a separate snare catheter may be delivered through the retrieval catheter. The snare may comprise alasso 30 or the like which engages the snaringhook 26 of the filter support frame. Theguidewire 10 may then be withdrawn or left in place. - In certain circumstances the
guidewire 10 could be retracted, or even removed completely (FIG. 8 ), without disturbing the position of the deployed filter in the vasculature. Anotherguidewire 10A may be advanced through the filter (FIGS. 9 and 10 ). This may be particularly advantageous in the case of certain interventional procedures, for example in coronary applications as will be described in more detail below. - The
support 3 may be configured to distribute the outward radial force over a relatively large area of the vasculature wall to minimise local stress distributions. - Many different designs of filter may be used such that on deployment, the filter applies a local radial force to the vasculature to substantially prevent movement of the filter relative to the vasculature in the deployed configuration. In the deployed configuration the filter is anchored to the vasculature. In some cases the filter comprises a filter body and a filter support frame to support the filter in the deployed configuration. The support frame and/or the filter body may comprise the anchor. The anchor may comprise a plurality of anchor elements which may be spaced-apart circumferentially around the filter when the filter is in the deployed configuration.
- Referring to
FIG. 17 the filter frame includes aproximal support hoop 31 with radially projecting vessel indentors orstabilisers 32 to prevent longitudinal movement of the filter in the vessel. The frame may include a snaringfeature 33 which may have aradiopaque marker 34. - Referring to
FIGS. 18 and 19 the vessel indentors orstabilisers 32 may also provide convenient attachment locations for attachment oftethers 35. Thetethers 35 may be interconnected at the proximal end by aconnector 36 which may be radiopaque for ease of location to snare the filter for retrieval. - Referring to
FIG. 20 the filter may have an enlarged lip 37 at the proximal end for engagement in a vessel to anchor the filter in a desired position. - Referring to
FIGS. 21 and 22 there is illustrated another filter which is apposed in a vessel. The filter has a retrieval mechanism somewhat like a closed drawstring arrangement with a mesh-like structure 38, when deployed, which may be engaged by thedistal tip 39 of a centering catheter (or any suitable snare) for collapsing the filter and drawing it into aretrieval catheter 40. - Another filter frame is illustrated in FIGS. 23 to 26. The frame has a
proximal hoop 41 and distally projectingarm 42. X denotes terminations of the bifilar type to facilitate wrap-down of the filter as illustrated inFIGS. 24 and 25 . Thus, the parking space occupied by the filter is optimised. In the deployed configuration in a vessel as schematically illustrated inFIG. 26 the filter opposes the vessel wall and rotation and translation of the filter in relation to the vasculature is prevented. - In general, the filter applies sufficient radial force to remain stable in a vessel when in the deployed configuration. In addition, the filter remains correctly orientated even without a guidewire in place. Some filters of this type are illustrated in FIGS. 27 to 31. In
FIG. 27 thefilter 43 has body support. InFIG. 28 thefilter 44 has stabilisingarms 45. The filter ofFIG. 29 is in the form of ahoop 46 with a number of inflection points 47. There may be four or more such inflection points as illustrated. - In
FIG. 30 the filter has two axially spaced-apartsupport hoops 48 which are interconnected by connectingarms 49. The filter ofFIG. 31 has two offsethoops 50. Any of these filters may be connected to a central tubular member by a rigid member(s) and/or by a tether(s). Many more arrangements with support in more than one place are envisaged. - The
filter 51 ofFIG. 32 has body support provided by a nitinol tube or wire. - To retrieve the
filter 710, any suitable means, such as the hooked retrieval catheter (FIG. 250 ), or the looped retrieval catheter (FIG. 251 ) may be used, in a manner similar to that described previously with reference toFIGS. 242 and 243 . Referring to FIGS. 32 to 39 there is illustrated adelivery catheter 200 which may be used with a filter of the invention. This catheter is described in detail in our co-pending U.S. Ser. No. 10/180,980, the relevant contents of which are incorporated herein by reference. Thedelivery catheter 200 comprises acatheter body 202 which extends between aproximal end 203 and adistal end 204, a restrainingsheath 210 at thedistal end 204 of thecatheter body 202, and an elongate actuator, which is provided in this case in the form of astainless steel wire 209. - The
catheter body 202 comprises aproximal hypotube portion 205 and a radially offsetdistal spring pusher 206. As illustrated inFIGS. 34 and 35 , the pusher 106 is fixedly attached to thehypotube 205 in a side-by-side overlapping arrangement with the proximal end of thepusher 206 located proximally of the distal end of thehypotube 205. - The
pusher 206 has aguidewire lumen 16 extending through thepusher 206 with anopening 217 at the proximal end of thelumen 216 for passage of aguidewire 222 through thelumen 216 and out through the proximal guidewire opening 217 (FIG. 35 ). Thedelivery catheter 200 is thus configured to be passed over theguidewire 22 in a rapid-exchange manner. - The
pusher 206 tapers proximally inwardly at theopening 217 for a smooth crossing profile. - When assembled, the
hypotube 205 and thepusher 206 are located substantially side-by-side. This side-by-side assembly of thehypotube 205 relative to thepusher 206 enables theguidewire 222 to exit through theproximal guidewire opening 217 smoothly and substantially parallel to the longitudinal axis of thecatheter 200. In particular, the passage of theguidewire 222 through theproximal guidewire opening 217 does not increase the overall profile of thecatheter 200. - A
connector shaft 212 is fixed to thesheath 210 with theshaft 212 extending proximally over thepusher 206 towards the distal end of thehypotube 205. The proximal end of thesheath 210 overlaps the distal end of theshaft 212, and amarker band 213 is located at the distal end of theshaft 212 between theshaft 212 and thesheath 210. - The
actuator wire 209 extends distally through anactuator lumen 232 in thehypotube 205, out of theactuator lumen 232 at the distal end of thehypotube 205, externally along thepusher 6 to the proximal end of theshaft 212. Thewire 209 is attached to the exterior surface of theshaft 212, for example by bonding. By attaching thewire 209 to the exterior of theshaft 212, this arrangement provides for more space within thepusher lumen 216 for guidewire passage. In addition, attachment of theactuator wire 209 to the exterior of theshaft 212 is an easier step to achieve from a manufacturing viewpoint than attachment to the interior of the relativelylong shaft 12. - The restraining
sheath 210 and theconnector shaft 212 are movable in a sliding manner relative to thecatheter body 202. When thesheath 210 extends distally of a distal end of thespring pusher 206, thesheath 210 defines aninternal reception space 211, as illustrated in FIGS. 36 to 38. A collapsedembolic protection filter 301 may be received within thereception space 211, where thefilter 231 will be restrained by thesheath 210 in a low-profile configuration during delivery to a desired site in a vasculature. A suitable material for thesheath 210 is polyethyleneterephthalate (PET). - The distal end of the
shaft 212 is flared outwardly (FIG. 38 ). During delivery of thefilter 231, the distal end of thepusher 206 is spaced proximally of the distal end of theshaft 212, and the proximal end of an innertubular member 236 of the filter is partially inserted into the flaredshaft 212. This arrangement provides a bridge in stiffness between the relativelystiff shaft 212 and the relatively stiff innertubular member 236 of thefilter 231. Thus the possibility of buckling of the relativelyflexible sheath 10 is minimised. The distal end of thepusher 206 is engagable with the innertubular member 236 of thefilter 231 upon retraction of thesheath 210 to deploy thefilter 231 out of thereception space 211. - As illustrated in
FIG. 39 , at theproximal end 203 of the catheter 200 adistal handle 208 is provided for gripping thecatheter body 202 and aproximal handle 214 is provided for gripping theactuator wire 209. Thedistal handle 208 is injection moulded over thehypotube 205 and theproximal handle 214 is crimped to the proximal end of thewire 209. - The
handles proximal handle 214 sliding within thedistal handle 208. Movement of thehandles annular protrusion 233 on theproximal handle 214 against the proximal end of thedistal handle 208 prevents further movement of theproximal handle 214 distally relative to thedistal handle 208. Engagement of ashoulder 234 on theproximal handle 214 with an inwardannular protrusion 235 on thedistal handle 208 prevents further movement of theproximal handle 214 proximally relative to thedistal handle 208. Areleasable safety clip 237 is provided to maintain thehandles - When the
catheter 200 is assembled thesheath 10 is directly connected to theproximal handle 214, and thepusher 206 is directly connected to thedistal handle 208. Movement of theproximal handle 214 proximally relative to thedistal handle 208 moves thewire 209, theconnector shaft 212 and thesheath 210 proximally relative to thepusher 206 to facilitate deployment of thefilter 231 from within thereception space 211. - The
delivery catheter 200 may be used to deliver theembolic protection filter 231 through a vasculature and to deploy theembolic protection filter 231 downstream of a stenosed region in the vasculature to prevent potentially harmful emboli, which may be released into the blood stream during treatment of the stenosis, such as by a stenting procedure, from migrating further through the vascular system. - Referring to FIGS. 40 to 54 the use of the
delivery catheter 200 will now be described in relation to afilter 301 of the invention which hastubular member 306 with a distal end that is spaced proximally from the distal end of the filter. Such as arrangement facilitates removal replacement of a guidewire and can also be readily snared and retrieved as described herein. - In use a
loading device 310 is partially inserted into thereception space 211 of thesheath 210. A pushingdevice 311 is then threaded through thetubular member 306 of thefilter 301 and extended into thereception space 211, as illustrated inFIG. 40 . - By moving the pushing
device 311 proximally, anengagement stop 312 on the pushingdevice 311 engages the distal end of thetubular member 306 and thefilter 301 is moved towards the loading device 310 (FIG. 10 ). Continued proximal movement of the pushingdevice 311 pushes thefilter 301 through theloading device 310, thereby collapsing thefilter 301, and into the reception space 11 (FIG. 41 ). - The
catheter 200 with thecollapsed filter 301 received within thereception space 11 are then moved together proximally away from the loading device 310 (FIG. 42 ). - The method of collapsing the
filter 301 and loading thefilter 301 into thereception space 211 is similar to that described in International patent application number PCT/IE01/00052, the relevant contents of which are incorporated herein by reference. - Next the
guidewire 222 is inserted into avasculature 315 and advanced through thevasculature 315 until theguidewire 222 has crossed a site of interest in the vasculature 315 (FIG. 44 ). A typical site of interest is a stenosed ordiseased region 316 of thevasculature 315. Thedelivery catheter 200 is then threaded over theguidewire 222 by inserting the proximal end of theguidewire 222 into theguidewire lumen 216 at the distal end of thepusher 206, through thelumen 216, and out of thelumen 216 through theproximal guidewire opening 217. Thecatheter 200 is advanced over theguidewire 222 in a rapid-exchange manner until thereception space 211 is located downstream of the stenosis 316 (FIG. 45 ). - To deploy the
filter 301 at the desired site in thevasculature 315 downstream of thestenosis 316, the proximal handle 14 is moved proximally while holding thedistal handle 208 fixed, thereby causing thepull wire 209 and theconnector shaft 212 to be pulled proximally. Because theconnector shaft 212 is attached to thesheath 210, thesheath 210 also moves proximally while thepusher 206 does not move. In this way, thecollapsed filter 301 is uncovered by thesheath 10 while the distal end of thepusher 206 abuts the proximal end of thetubular member 306 of thefilter 301. Thedelivery catheter 200 thus enables the self-expandingfilter 301 to expand outwardly to a deployed configuration. The distal end of thepusher 6 acts as an abutment for a controlled, accurate deployment of thefilter 301 at the desired site in thevasculature 315. - When the filter 230 has been fully deployed at the desired site in the
vasculature 315, thedelivery catheter 200 is withdrawn from thevasculature 315 over theguidewire 222 in a rapid-exchange manner to leave the deployedfilter 301 in place in the vasculature 315 (FIG. 48 ). - Various procedures can be carried out using the guidewire such as an angioplasty using a balloon 320 (
FIG. 49 ) or a stenting procedure with a stent 321 (FIG. 50 ). On completion of the procedures a retrieval device such as aretrieval catheter 325 or snare may be used to retrieve the filter (FIGS. 51 to 53). Theguidewire 222 may be left in place or removed. - In FIGS. 55 to 57 there is illustrated another
delivery catheter 600 according to the invention, which is similar to thedelivery catheter 200 and similar elements are assigned the same reference numerals. In this case the distal end of theshaft 212 is not flared outwardly, and the proximal end of the innertubular member 306 is not inserted into theshaft 212, during delivery of theembolic protection filter 610. - Instead a bridging
sleeve 601 is provided mounted around theshaft 212 distally of themarker band 213, as illustrated inFIG. 57 . Thesleeve 601 extends distally of the distal end of theshaft 212, such that the proximal end of the innertubular member 306 of thefilter 610 may be partially inserted into thesleeve 601 during delivery of the filter 610 (FIG. 57 ). This arrangement provides a bridge in stiffness between the relativelystiff shaft 212 and the relatively stiff innertubular member 306 of thefilter 610. Thus the possibility of buckling of the relativelyflexible sheath 210 is minimised. - It is noted that the
filter 610 of FIGS. 57(a) to 57(c) is of a different configuration to the filter described previously. In particular the innertubular member 306 of thefilter 610 does not have any step formations or protrusions at the proximal end of the innertubular member 306. - The delivery catheter of the invention is also suitable for over-the-wire exchange over a guidewire. The rapid exchange configuration is not essential.
- Referring to FIGS. 58 to 61 there is illustrated one means of temporarily providing a tubular lumen in a filter to facilitate delivery of the filter to a desired location. In this case an introducer tool is in the form of a C-shaped
tubular member 60 with a distal peel-back feature 61. The tool is inserted into the distal end of thefilter 62 as illustrated inFIG. 58 . The filter is loaded into adistal pod 63 of a delivery catheter 64 (FIG. 58 ) and the distal end of thedelivery catheter 64 is threaded over the proximal end of a deployedguidewire 65. When the guidewire has passed through the filter the introducer may be pulled away and removed as illustrated inFIG. 61 . - In another arrangement illustrated in FIGS. 62 to 65 the
delivery catheter 70 may itself be provided with amember 71 defining a temporary tubular member for a guidewire. The tubular member may also function as a pusher. In one case once the guidewire has traversed thefilter 62 thetubular member 71 may be positioned proximal of the filter during delivery and deployment (FIGS. 63 to 65). In another case (FIGS. 66 to 68) thetubular member 71 may extend through the filter up to the stage when the delivery catheter is being withdrawn. - The
pusher 71 may pass through the centre (FIGS. 71 and 72 ) of the filter or may run beside the filter (FIGS. 69 and 70 ). - In
FIGS. 73 and 74 , there is illustrated anotherembolic protection filter 520 according to the invention. In the case offilter 520, theguidewire lumen 521 through thefilter 520 is defined by twotelescoping tubes proximal tube 522 is fixed to thefilter 520 at the proximal end of thefilter 520, and thedistal tube 523 is fixed to thefilter 520 at the distal end of thefilter 520. - In the deployed configuration of
FIG. 73 , thedistal tube 523 telescopes proximally over theproximal tube 522 so that the overall parking space of thefilter 520 in a vasculature is minimised. In addition thedistal tube 523 is spaced distally of theguidewire aperture 112 to facilitate crossing of thefilter 520 with a guidewire without requiring the guidewire to be threaded through thetubes - In the collapsed configuration of
FIG. 74 , thedistal tube 523 telescopes distally over theproximal tube 522 so that theguidewire lumen 521 is defined through the entire length of thefilter 520 when collapsed, for example in apod 524 of adelivery catheter 525. - The invention also envisages the use of a
delivery catheter 650, as illustrated in FIGS. 75 to 89, which is particularly suitable for delivering anembolic protection filter 651, as illustrated inFIG. 77 , thefilter 651 not having an inner tubular member to define a guidewire lumen through thefilter 651. - The
delivery catheter 650 comprises an outertubular member 652, and an innertubular member 653, the innertubular member 653 being movable distally relative to the outertubular member 652 from a delivery configuration (FIG. 76 ) to a deployment configuration (FIG. 78 ). - In the delivery configuration, the
catheter 650 defines areception space 654 for receiving thefilter 651 in a collapsed configuration, as illustrated inFIG. 77 . When the innertubular member 653 is moved distally relative to the outertubular member 652, thefilter 651 is pushed distally out of thereception space 654 by means of an engagement between ashoulder 655 of the innertubular member 653 and thecollapsed filter 651. - The invention provides features to enable a guidewire to be repositioned across the filter. It may be necessary to be able to replace the guidewire if the wire became accidentally withdrawn by the user during the procedure. It may then be necessary to replace the wire in order to access the lesion with other devices such as a balloon or stent catheter or even the filter retrieval catheter. Merely advancing a wire up to the filter is unlikely to provide sufficient support in all cases. Guidewire replacement may also be needed if the user desires to use a wire with different properties during the procedure. For example a very torqueable wire may be ideal for initially accessing and crossing the lesion, and may have adequate support to enable the filter to be delivered and deployed, but may not have sufficient support to enable a stiffer stent delivery system to reach the lesion. The invention facilitates removal of the first wire and replacement with a more supportive guidewire to facilitate use of the stent delivery system. This may be achieved without having to use an additional exchange catheter.
- This invention describes a filter which comprises a guidewire recrossing feature, wherein this feature may comprise some or all of a guiding funnel, a pathway and a blood restrictor. A guiding funnel is used as this operation will be performed “blind”. In general, it would be difficult to replace a guidewire through a tubular lumen while the filter is in the patient. In the invention the guidewire may be passed through the distal filter neck. The distal cone of the filter will act as a guiding channel. However the guidewire tip is very flexible—if it is to open a “valve” or blood restrictor it will need to have good push. In order to provide this push it is necessary to restrain the guidewire tip within a relatively narrow channel—this channel is provided by the filter neck. A restrictor may be provided to prevent any loss of embolic material while the first guidewire was absent—during which period the neck of the filter would be an open hole if no restrictor were present. This restrictor is intended simply to close and prevent blood flow in the absence of a guidewire. Once there is no blood flow through the filter neck embolic material will not collect there and will not restrict the passage of the second guidewire.
- Various guideways may be provided for a guidewire to assist crossing of a filter. Referring to FIGS. 79 to 81 the pathway may be provided around the filter, for example in a
side channel 80. Aradiopaque feature 81 may be provided on the filter to guide a user to the passageway. Alternatively the pathway may be through the filter to a single exit 82 (FIG. 82 ), a separate exit 83 (FIG. 83 ) or through thesame exit 84 using a shortenedtubular member 85 illustrated inFIG. 84 and described in more detail herein. In these cases the guidewire passage/hole may be sealed to prevent passage of embolic therethrough as will be described in more detail below. - Referring now to FIGS. 85 to 92, there is illustrated another
embolic protection filter 50 according to the invention. Thefilter 150 comprises a receiver to guide a docking device into association with thefilter 150. In this case, the receiver is configured to guide a guidewire, such as theguidewire 130, into theguidewire lumen 112. The receiver is provided by afunnel 151 which diverges outwardly proximally, thefunnel 151 being mounted to thefilter 150 to extend proximally of the inlet end of thefilter 150. - In this specification, the term funnel will be understood to mean any orifice with a cross-sectional area that decreases with distance.
- The
funnel 151 may comprise a collapsible funnel body in the form of amembrane 152, which in this case is supported by a collapsible funnel support, in the form of a plurality ofsupport fingers 153. Thefingers 153 are pivotally mounted to thefilter 50 and are biased to move thefilter membrane 152 from a collapsed configuration for movement through the vasculature, to an outwardly extended configuration for guiding theguidewire 130, as illustrated inFIG. 86 . Thefunnel 151 may be of a radiopaque material. - The
funnel 151 may be used to guide theguidewire 130 along a pathway that enables theguidewire 130 to cross thefilter 150. Thefunnel 151 allows the procedure of leading thesmall diameter guidewire 130 through the small diameter guidewire lumen of thefilter 150 to be performed more easily by guiding the tip of theguidewire 130 towards the proximal end of theguidewire lumen 158. - Use of the
funnel 151 is particularly beneficial in the case where it is desired to lead theguidewire 130 through the guidewire lumen while thefilter 150 is deployed in the vasculature, as illustrated in FIGS. 87 to 89. Thefunnel 151 enables a clinician to accurately and quickly thread theguidewire 130 through the guidewire lumen without risk of puncturing the filter body or of disturbing thefilter 50 from its deployed position in the vasculature in apposition with the wall of the vasculature. - The
filter 150 further comprises at least one, and in this case two,seals guidewire lumen 158 to prevent embolic material from passing through theguidewire lumen 158, when thefilter 150 is in use in the vasculature. - The
seals seal 160 located at the proximal end of thefilter 150, and theother seal 161 located at the distal end of thefilter 150. - The
proximal seal 160 may be in the form of a tubular member of a soft membrane material. Theguidewire lumen 158 extends through thetubular seal 160 and theseal 160 is closable down to seal theguidewire lumen 158. - The
distal seal 61 is in the form of a tubular member with two or more, and in this case seven, circumferentially overlapping flaps, as illustrated inFIG. 92 . Thisseal 161 is also closable down to seal theguidewire lumen 158. - It will be appreciated that the
guidewire lumen 158 can be provided as any suitable passageway through thefilter 150. Theguidewire lumen 158 does not have to be located along the central axis of thefilter 150. Theguidewire lumen 158 may be radially offset from the longitudinal axis of thefilter 150. - When the
guidewire 30 is extended through theguidewire lumen 158, theseals guidewire 130 to prevent emboli flowing through theguidewire lumen 158. Upon removal of theguidewire 130 from theguidewire lumen 158 while thefilter 150 is deployed in the vasculature, theseals guidewire lumen 158. - In this manner, the
seals guidewire lumen 158. All blood flows into the filter body through the inlet openings and out of the filter body through the small outlet openings, thereby trapping and safely retaining the undesired embolic material within thefilter 150. - After an embolic protection filter has been delivered over a guidewire and deployed in a vasculature, it is not always possible to withdraw the guidewire from the vasculature before collapsing and withdrawing the filter from the vasculature.
- However in some cases it may be necessary to withdraw the guidewire over which the filter was delivered while leaving the filter deployed in the vasculature.
- Examples of when this need may arise are:
-
- when a high torque guidewire is used to facilitate filter delivery and deployment, and a stiffer guidewire is subsequently used to
- provide additional support during delivery and deployment of a stent;
- when a guide catheter has prolapsed;
- when a guidewire is withdrawn into a guide catheter to accelerate rate of resolution of a spasm.
- When this need does arise, the
filter 50 of the invention may be used to filter potentially harmful emboli from a vasculature when the guidewire is withdrawn, while the filter remains deployed in the vasculature, as illustrated in FIGS. 93 to 110. - A
first guidewire 130 is introduced into and advanced through thevasculature 121 to cross the treatment location 122 (FIG. 93 ), and thefilter 150 is delivered through thevasculature 121 and deployed distally of the treatment location 122 (FIGS. 94 to 97), in a manner similar to that described previously. - In the outwardly extended configuration, the deployed
filter 150 is retained in position in thevasculature 121 against substantial longitudinal movement by the radial apposition force of the filter body against the wall of thevasculature 121. Thefirst guidewire 130 can thus be withdrawn from the guidewire lumen of thefilter 150, and completely withdrawn from thevasculature 121 without disturbing the outwardly extended configuration of thefilter 150 in thevasculature 121. - The deployed
filter 150 is retained in position in thevasculature 121 against substantial longitudinal movement by means of the radial apposition force exerted by the filter support on the filter body and the vasculature wall, as described previously. - A
second guidewire 140 is then introduced into thevasculature 121 and advanced through thevasculature 121 until thesecond guidewire 140 crosses the desiredtreatment location 122. The tip of thesecond guidewire 140 is guided towards the proximal end of the guidewire lumen by engagement of the guidewire tip with thefunnel 151, and thesecond guidewire 140 is then lead through the guidewire lumen. - A
stent 136 may then be delivered through thevasculature 121, and deployed at thetreatment location 122 using thestent delivery catheter 135. In this case, thestent delivery catheter 135 passes over thesecond guidewire 140. After completion of the interventional procedure, theretrieval catheter 120 is advanced to cross thestent 136 and thetreatment location 122, and the tip 125 is engaged with thefilter 150. As the tip 125 passes through thefunnel 151, thefunnel 151 is caused to collapse down to the collapsed configuration. Thefilter 150 is then collapsed and retrieved into theretrieval catheter 120 and withdrawn from thevasculature 121. Upon collapse of thefilter 1, the apposition of the filter with thevasculature 121 is released. - The
filter 150 ensures any embolic material generated during the interventional procedure is captured and safely removed from thevasculature 121. - The
second guidewire 140 may be of a different diameter, or have different material properties to thefirst guidewire 130. It may thus be easier or more suitable for the clinician to advance thestent delivery catheter 35 over thesecond guidewire 140 rather than over thefirst guidewire 130. For example, it is sometimes the case that ahigh torque guidewire 130 is used to facilitate filter delivery and deployment, and astiffer guidewire 140 is used subsequently to provide additional support during delivery and deployment of a stent. - In some cases, it may be necessary or desirable to withdraw the
second guidewire 140 from thefilter 150 and thetreatment location 122 after deployment of thestent 136, and then to advance a third guidewire through thevasculature 121 to the filter, theretrieval catheter 120 then being advanced over the third guidewire to retrieve thefilter 150. This invention enables such a procedure to be carried out. Furthermore withdrawing a guidewire into a guide catheter may accelerate the resolution of spasm and reduce the risk of ischaemia. - Referring to FIGS. 111 to 114, there is illustrated another retrieval catheter according to the invention, which is similar to the retrieval catheter of FIGS. 190 to 192. In this case, the catheter body 23 defines a
guidewire lumen 151 radially offset from the coupling member 24. Theguidewire lumen 151 extends through only part of the catheter body 23 to facilitate passage of the catheter body 23 over a guidewire, such as theguidewire 140, in a rapid exchange manner. - In use, the
retrieval catheter 150 may be used to retrieve thefilter 1 deployed in thevasculature 21. - In one possible procedure, the
second guidewire 140 is not led through theguidewire lumen 12 of thefilter 1. Instead thesecond guidewire 140 is advanced until theguidewire 140 has crossed the treatment location and the guidewire tip is proximally of the filter 1 (FIG. 113 ). Thefilter 1 is then retrieved into the catheter body 23. During this procedure theretrieval catheter 150 may be advanced distally off the end of theguidewire 140. -
FIG. 115 illustrates anotherfilter 170 according to the invention. In this case, thefunnel 151 is mounted to thefilter 170 distally of the inlet end of thefilter 170, so that thefunnel 151 is located at least partially within thefilter 170. - It will be appreciated that the receiver may be detachably mounted to the filter. For example, the receiver may be mounted to the filter after deployment in a vasculature, and/or may be detached from the filter before retrieval of the filter from a vasculature.
- In addition, the receiver may be radially offset from the longitudinal axis of the filter.
- Referring to
FIGS. 116 and 117 , there is illustrated anotherfilter 180 according to the invention. The funnel is provided, in the case offilter 180, by slopingwalls 181 of the filter body at the inlet end. As theguidewire 130 is advanced to thefilter 180, the tip of theguidewire 130 meets the slopingwalls 181 of the filter body and is guided distally inwardly towards the proximal end of the guidewire lumen. In this manner, the slopingwalls 181 enable theguidewire 130 to be easily and quickly threaded into the guidewire lumen. - The angle of inclination α of these sloping
walls 181 can be altered, as indicated inFIG. 117 , to suit the characteristics of the interventional procedure, and/or the vasculature, and/or the guidewire. - The large inlet openings enable substantially unrestricted flow into the filter body, and the
sloping walls 81 may be radiopaque material to aid guidewire passage. -
FIG. 118 illustrates afurther filter 190 according to the invention. In this case, thefilter 190 has aguidewire aperture 192 for passing thefilter 190 over theguidewire 130, and thefilter 190 has a single, large inlet opening 191 at the inlet end of theother filter 190. The single, large inlet opening 191 provides no resistance to blood flow into the filter body. - The sloping
walls 192 at the outlet end of thefilter 190 provides the funnel, in this case, to guide theguidewire 130 towards theguidewire aperture 192. - It will be appreciated that the outlet openings are smaller, in this case, than the guidewire diameter, thus the
guidewire 130 does not snag or pass through the outlet openings but instead theguidewire 130 is guided distally inwardly to theguidewire aperture 192. - The filter 90 may have a
guidewire aperture 112 for passing the filter 90 over theguidewire 30, and the filter 90 has a single, large inlet opening 91 at theinlet end 4 of the filter 90. The single, large inlet opening 91 provides no resistance to blood flow into thefilter body 2. - The sloping
walls 190 at the outlet end of thefilter 190 provides the funnel, in this case, to guide theguidewire 130 towards theguidewire aperture 192, as illustrated inFIGS. 119 and 120 . - It will be appreciated that the outlet openings are smaller, in this case, than the guidewire diameter, thus the
guidewire 130 does not snag or pass through the outlet openings but instead theguidewire 30 is guided distally inwardly to theguidewire aperture 192. - As illustrated in FIGS. 119 to 121 the
filter 190 further comprises a distal seal at theguidewire aperture 192 in the form of an elastomeric self-sealingvalve 400. Thevalve 400 has co-operating flaps which meet centrally to close off theguidewire aperture 192 when the guidewire is not extended through theaperture 192, as illustrated inFIGS. 119 and 121 . As the guidewire is pushed through theguidewire aperture 192, the flaps of thevalve 400 are forced apart to permit passage of theguidewire 130, as illustrated inFIG. 120 . - It will be appreciated that the
valve 400 could alternatively be provided in the form of four, two, or any other number of co-operating flaps. - Referring to FIGS. 122 to 127 the guidewire exit hole may be sealed with a thin
flexible membrane 401 which can withstand any pressure differential across the filter but can be deformed by the guidewire tip to open the seal/membrane. Various options are possible such as those illustrated in FIGS. 123 to 126. - Another option is to provide a seal in the form of an invertible
flexible tube 402. The tube may haveslits 403 for additional flexibility.FIG. 128 shows an initial guidewire in position,FIG. 129 shows the wire removed and the tube collapsed, sealing the hole. InFIG. 130 a new wire is shown being advanced through the filter, the advancing of the wire pushing the tube out of the filter neck and forming a seal with the new wire as illustrated inFIG. 131 . The tube may be slits or slots for added flexibility as illustrated inFIG. 132 . - The guidewire exit hole may also be sealed by a flap valve or the like. Referring to FIGS. 133 to 135 a
closure flap 410 is hingedly connected to thefilter 411 by acurved lever 412. Thehinge point 413 is stepped back proximally from theflap 410 so that the pressure drop across theflap 410 does not cause theflap 410 to open. Theflap 410 is opened against the biasing of thelever 412 on insertion of aguidewire 415 as illustrated inFIGS. 134 and 135 . - It will be appreciated that the hinge may have a range of different constructions. For example, as illustrated in
FIG. 136 a hinge 416 may be provided by a flattened wire or ahinge 417 may be formed by a narrowing of the lever as illustrated inFIG. 137 . - In another embodiment illustrated in FIGS. 138 to 140 a
distal end 420 of a filter may have a flattenedneck section 421 which normally seals aguidewire aperture 422 but which can be opened to facilitate passage of awire 423. - A further embodiment is illustrated in FIGS. 141 to 143 in which the filter distal guidewire aperture has a foam-
like insert 425 with slits to facilitate deformation of the foam as aguidewire 426 is inserted whilst still maintaining a sealing engagement with theguidewire 426. - In the invention the retrieval device grips and retrieves the filter. Conventional filters are retrieved by using the guidewire to engage with the filter. This invention describes a retrieval device with one member which engages with and restrains the filter while a second member may envelop the filter. The retrieval device may function in the absence of a guidewire so that the filter can be retrieved even if the user has removed the guidewire and failed to replace it. This retrieval process may involve three stages: 1) Engage with the filter, 2) Decouple filter from vessel, 3) Retrieve the filter. Alternatively the retrieval may involve two stages: 1) Engage with the filter, 2) Retrieve the filter.
- The retrieval process is simple and reliable. The snare (or loop or lasso) designs described provide one of the most reliable and versatile methods. There is preferably a feature on the filter with which this snare will engage easily. This feature and the snare loop are preferably radiopaque for ease of visibility and positioning. For example a large radiopaque ball (or shepherds crook) inside the filter may be pulled proximal to the filter when snared and wrapped down.
- Referring in particular to FIGS. 144 to 146, there is illustrated a
retrieval catheter 620 according to the invention. Theretrieval catheter 620 is suitable for retrieving a filter, deployed in avasculature 621 distally of atreatment location 622, such as a region of stenosis. - The
catheter 620 comprises anouter catheter body 623 and a coaxialinner coupling member 624, thecoupling member 624 having means for coupling to the filter especially a filter deployed in thevasculature 621 to be retrieved. - The coupling means is provided, in this case, by an arrow-head shaped
tip 625 on thecoupling member 624. Thetip 625 has twomale fingers 626 for engagement with two correspondingfemale recesses 627 on thefilter 1. - The
male fingers 626 are moveable between a low-profile configuration and an outwardly protruding configuration for engagement with the filter. In this case, thefingers 626 are of a resilient material, and are biased towards the outwardly protruding configuration. - During introduction of the
retrieval catheter 620 through thevasculature 621, thetip 625 protrudes only partially distally of the distal end of thecatheter body 623, so that theresilient fingers 626 are maintained in the low-profile configuration. The protrudingtip 625 prevents snagging of the open mouth of thecatheter body 623 against any protruding parts of the vasculature wall. In addition thetip 625 tapers distally inwardly for a smooth crossing profile. - When the
retrieval catheter 620 has crossed thetreatment location 622, thecoupling member 624 is moved distally relative to thecatheter body 623, to release theresilient fingers 626 to move to the outwardly protruding configuration. Thecoupling member 624 is then moved further distally into the filter until thefingers 626 engage with therecesses 627 of the filter. - The
recesses 627 may be defined in a more pronounced manner by providing inwardly protruding steps or abutments on the proximal end of the filter support against which thefingers 626 may engage. - The
catheter body 623 is next moved distally relative to the engagedfilter 1 by maintaining the position of thecoupling member 624, the distal end of thecatheter body 623 is engaged with the proximal end of the filter body, thecatheter body 623 is further advanced and thus the coupledfilter 1 is collapsed down releasing the apposition force and is retrieved into thecatheter body 623. When thecollapsed filter 1 has been fully retrieved into thecatheter body 623, theretrieval catheter 620 is withdrawn with thefilter 1 from thevasculature 621. - The
coupling member 624 of theretrieval catheter 620 enables a deployed medical device, such as thefilter 1, to be retrieved into theretrieval catheter 620 with any retained embolic material within thefilter 1 without requiring a step, or a clamp or any special stop features on the guidewire. Thus theretrieval catheter 620 enables thefilter 1 to be used in combination with any standard guidewire. - In addition, it is not necessary to retract the guidewire to facilitate retrieval of the
filter 1. - In certain circumstances if the guidewire was withdrawn from the deployed
filter 1 it would still be possible to retrieve thefilter 1 using the retrieval catheter of the invention. This could speed up the overall procedure. Also in some cases it may be difficult to recross thefilter 1 with a guidewire. Furthermore by obviating the need to recross thefilter 1 with a guidewire, the possibility of a spasm being caused is minimised. - FIGS. 152 to 165 illustrate the
embolic protection filter 1 and theretrieval catheter 620 according to the invention, in use. - A
guidewire 630 is introduced into and advanced through thevasculature 621 until theguidewire 630 crosses the desiredtreatment location 622. Adelivery catheter 631 is then used to deliver theembolic protection filter 1 through thevasculature 621 over theguidewire 630, thefilter 1 being housed within adistal pod 632 of thedelivery catheter 631 in the collapsed configuration. - The
filter 1 may in one case be loaded into adelivery catheter 631 as described in International patent applications Nos. PCT/IE01/00052 and PCT/IE01/00053, the relevant contents of which are incorporated herein by reference. It will be appreciated that other loading alternatives are also possible. - When the
distal pod 632 has been advanced to a desired site distal to thetreatment location 622, thepod 632 is moved proximally relative to an inner pusher to deploy thefilter 1 out of thepod 632 into the outwardly extended configuration, as described in further detail in International patent applications Nos. PCT/IE01/00052 and PCT/IE01/00053. After complete deployment of thefiler 11 thedelivery catheter 631 is withdrawn from the vasculature 621 (FIG. 11 ). - In the outwardly extended configuration the
filter 1 is in apposition with thevasculature 621, thereby preventing blood flow from bypassing thefilter 1 between thefilter 1 and thevasculature 621. The radial apposition force of the filter support against the filter body and the wall of thevasculature 621 retains thefilter 1 in position against substantial longitudinal movement, even if theguidewire 630 is moved or indeed removed. In this way thefilter 1 is prevented from migrating downstream in thevasculature 621. - An interventional procedure is then carried out at the
treatment location 622. In the case illustrated, the interventional procedure is a stenting procedure using a self-expanding stent. However, a range of procedures are possible as alternatives to or in addition to stenting, for example a balloon angioplasty procedure, a balloon-expandable stenting procedure, an atherectomy procedure, a lysis. - A
stent delivery catheter 635 is used to deliver a stent, such as aself expanding stent 636, through thevasculature 621, thestent 636 being held in a collapsed configuration by a restrainingsheath 637 of thestent delivery catheter 635. - When the
stent delivery catheter 635 has been advanced to thetreatment location 622 thesheath 637 is moved proximally relative to aninner body 638 of thecatheter 635 to facilitate deployment of thestent 636 at thetreatment location 622. - After complete deployment of the
stent 636, thestent delivery catheter 635 is withdrawn from thevasculature 621, leaving the deployedfilter 1 and the deployedstent 636 in thevasculature 621. - Any embolic material generated during delivery or deployment of the
stent 636, or during withdrawal of the stent delivery catheter 639 is captured and safely retained in the deployedfilter 1. - After completion of the interventional procedure, the
retrieval catheter 620 is introduced into thevasculature 621, and advanced through thevasculature 621 until thestent 636 and thetreatment location 622 have been crossed. - The
filter 1 is simultaneously collapsed and retrieved into thecatheter body 623 of theretrieval catheter 620 and with it the captured embolic material, by engaging thetip 625 with thefilter 1, and then advancing thecatheter body 623 distally over thecoupling member 624 and the engagedfilter 1. - Upon collapse of the
filter 1, the apposition of thefilter 1 with thevasculature 621 is released. - When the
filter 1 has been fully collapsed and retrieved into theretrieval catheter 620, theretrieval catheter 620 with thecollapsed filter 1 and retained emboli therein are withdrawn from thevasculature 621, leaving the deployedstent 636 in place at thetreatment location 622 in thevasculature 621. - In this way, the
filter 1 may be used to capture and safely remove any embolic material which has been generated during the interventional procedure. - An expandable balloon may be provided on the filter to enhance the outward radial force on the vasculature wall to retain the filter in position against substantial longitudinal movement. In use, the balloon may be inflated after deployment at the desired site in the vasculature to effectively anchor the filter in position. The balloon may be subsequently deflated before retrieval of the filter.
-
FIGS. 64 and 165 illustrate another embolic protection filter 300 according to the invention. The filter 300 comprises acapture tether 301 which extends externally of thefilter body 2 from a proximal ring 302, to which thetether 301 is fixed, to a distal capture hoop 303. The capture hoop 303 is located around the distal core at theoutlet end 5 of the filter 300 when the filter 300 is in the outwardly extended configuration, as illustrated inFIG. 164 . The capture hoop 303 is slidable over the filter body. To collapse and retrieve the filter 300 into theretrieval catheter 20, the coupling member 24 engages thecapture tether 301 and causes the capture hoop 303 to move proximally. The coupling member 24 may be engaged with thecapture tether 301 using a hook, or loop, or any other suitable coupling means, as described previously. In this manner the filter 300 is compressed for retrieval into the catheter body 23, as illustrated inFIG. 165 . - The coupling means may alternatively be provided by a male member in the form of a
hook 700, as illustrated inFIG. 166 for hooking around a receiver on thefilter 1. Thehook 700 may be used to couple the coupling member 24 to any suitably configured embolic protection filter. - For example, an
embolic protection filter 710, illustrated inFIGS. 168 and 169 , has atether arm 711 at a proximal end of thefilter 710 around which thehook 700 may be extended to couple the deployedfilter 710 with the coupling member 24 and thereby facilitate retrieval of thefilter 710 into the catheter body 23. - FIGS. 170 to 173 illustrate further
embolic protection devices - The
filter 720 ofFIG. 170 has threetether arms 721 which extend radially inwardly from thefilter body 2 to meet at acentral point 722. Thehook 700 may be extended around any one of thetether arms 721 to couple the coupling member 24 to thefilter 720. This tether arrangement enables thefilter 720 to be retrieved with a central, axial pull force. - In the
filter 725 ofFIG. 172 , the threetether arms 726 extend radially inwardly and distally to thecentral point 727. In this manner thecentral point 727 is stepped back distally from the single,large inlet opening 6 to minimise the possibility of embolic material becoming caught or hung up on thetether arms 726. - The
filter 730 ofFIG. 173 has a central ring 332 to which the tether arms 331 are fixed. - FIGS. 174 to 178 illustrate the
embolic protection filter 710, being retrieved into the catheter body 24 usinggrasping jaws 906. In this case, thejaws 906 compriseserrated edges 750 to achieve a secure grasping of thetether arm 711. In this manner, thefilter 710 may be coupled to the coupling member 24 and retrieved into the catheter body 23. Theretrieval catheter 905 is withdrawn from the vasculature after retrieving thefilter 710 leaving theguidewire 30 remaining in the vasculature. - The tether arms of any of the above described embodiments may be mechanically attached at the central point, and/or at the central ring, and/or to the
filter body 2, for example by bonding, or welding, or brazing. Alternatively the tether arms may be provided integral with the mesh/membrane of thefilter body 2. The tether arms could also be provided as a fibre from such a mesh. - In the
embolic protection filter 410 ofFIG. 179 thetether arm 411 is located within thefilter 410. To couple the coupling member 24 to thefilter 410, thehook 100 is extended into thefilter 410 and hooked around thetether arm 411. - In the
filter 413 ofFIG. 180 , twotether arms 412 are provided. It will be appreciated that any suitable number of tether arms may be provided at either end of an embolic protection filter, and/or within the filter. - Referring to
FIGS. 181 and 182 , there is illustrated anotherembolic protection filter 500 according to the invention, which is similar to thefilter 720. - In this case, the
filter 500 comprises an innertubular member 502 to which the threetether arms 501 are fixed. Thetubular member 502 defines a guidewire lumen 503 therethrough for passing aguidewire 530 through the tubular member 502 (FIG. 181 ). - The
tubular member 502 extends through only part of thefilter 500. As illustrated inFIG. 182 , this enables theguidewire 530 to cross thefilter 500 without having to thread theguidewire 530 through the relatively small diameter guidewire lumen 503. - This configuration may be particularly advantageous when it is desired to cross the
filter 500 with a guidewire while thefilter 500 remains deployed in a vasculature. In this circumstance, the distal end cone of the filter body may act as a guide to guide theguidewire 530 through theguidewire aperture 112. - The
tubular member 502 of theembolic protection filter 510 illustrated inFIG. 183 also extends only partially through thefilter 510 to facilitate crossing of thefilter 510 with theguidewire 530 without requiring threading of theguidewire 530 through thetubular member 502. - It will be appreciated that any other suitable means for coupling the deployed
filter 1 with the coupling member 24 of theretrieval catheter 20 may be employed to facilitate retrieval of thefilter 1 into the catheter body 23, for example the coupling member 24 may be provided with one or more female recesses for engagement with one or more corresponding male protrusions on thefilter 1. - Alternatively a female member on the coupling member 24 may be provided in the form of a
loop 701, as illustrated inFIG. 167 , for looping around amale stub 702 protruding from thefilter 1. - Referring to FIGS. 184 to 189 there is illustrated another
retrieval catheter 905 according to the invention. In this case, the coupling member 24 comprises a pair ofjaws 906 at the distal end of the coupling member 24. Thejaws 906 are movable between an outwardly protruding configuration (FIG. 186 ) and a low-profile configuration (FIG. 187 ) to grasp thefilter 1. - The
jaws 906 are biased towards the low-profile configuration and may be moved outwardly by moving an innerelongate actuator 907 longitudinally distally relative to thejaws 906 to engageelbows 908 on thejaws 906 and thereby move thejaws 906 outwardly in a camming arrangement (FIG. 186 ). - The
jaws 906 define a recessedportion 909 a for co-operation with a protrudingneck 909 b on the proximal end of thefilter 1 during grasping of thefilter 1, as illustrated inFIG. 187 . - In use, the
retrieval catheter 905 is advanced through thevasculature 21 in the low-profile configuration until thejaws 906 are proximally adjacent to the deployedfilter 1. Theactuator 907 is then moved distally relative to thejaws 906 to cam thejaws 906 open, and the openedjaws 906 are advanced until the recessedportion 909 a of thejaws 906 are around the protrudingneck 909 b of thefilter 1. By moving theactuator 907 proximally relative to the coupling member 24 thejaws 906 are released to move inwardly to grasp thefilter 1 around theneck 909 b. The graspedfilter 1 may then be retrieved into the catheter body 23 by moving the catheter body 23 distally relative to the coupling member 24. - It will be appreciated that the
jaws 906 may grasp any suitable part of thefilter 1 to facilitate retrieval. For example, thejaws 906 may grasp thefilter 1 at theinlet openings 6, as illustrated inFIGS. 188 and 189 . - As illustrated in FIGS. 190 to 191, the
jaws 906 may alternatively be biased outwardly. During advancement of theretrieval catheter 905 through thevasculature 21, thejaws 906 are restrained in the low-profile configuration by the catheter body 23 (FIG. 190 ). To move thejaws 906 outwardly, the coupling member 24 is moved distally relative to the catheter body 23 to release thejaws 906 to spring outwardly (FIG. 191 ). - To subsequently move the
jaws 906 inwardly when the recessedportion 909 a of thejaws 906 are around the protrudingneck 909 b of thefilter 1, the catheter body 23 is moved distally relative to the coupling member 24 to engage thejaws 906 and move thejaws 906 inwardly to grasp thefilter 1 around theneck 909 b. Thefilter 1 is then retrieved into the catheter body 23 by advancing the catheter body 23 further distally relative to the coupling member 24 and the grasped filter 1 (FIG. 192 ). - Alternatively, the coupling member 24 may have a
magnetic tip 25 for magnetic coupling to an oppositely charged magnetic portion of thefilter 1. -
FIGS. 193 and 194 illustrate anotherretrieval catheter 940 according to the invention. - In this case, the
retrieval catheter 940 comprises asecond coupling member 941, which is movable relative to the first coupling member 24. In this way, thesecond coupling member 941 may be used to axially elongate an element of the deployedfilter 1, such as thefilter support frame 3, to collapse thefilter 1 to the low-profile configuration for retrieval into the catheter body 23. In this case, thesecond coupling member 941 acts as a pusher and is movable distally relative to thetip 25. By engaging thetip 25 with thefilter support 3 and then moving thesecond coupling member 41 distally to engage adistal end 42 of thefilter support 3, thefilter support 3 is axially elongated and thefilter 1 is collapsed from the outwardly extended configuration ofFIG. 194 to the collapsed configuration. - The
collapsed filter 1 may then be retrieved by moving the catheter body 23 distally relative to thetip 25 and the engagedfilter 1. - Referring to FIGS. 195 to 201 there is illustrated another filter retrieval system of the invention. In this case a snare type retrieval is used for a
filter 850 with aguidewire 851 extending through atubular member 852. Thetubular member 852 has a projectinghead portion 853 with an associatedmarker band 854 for engagement by a lasso orloop 855 delivered through aretrieval catheter 856 into which the filter is retrieved as illustrated. - Another embodiment is illustrated in FIGS. 202 to 206 which is used for retrieval of a
filter 860 which does not have a tubular member. In this case the filter frame has asnare receiving projection 861 which is engaged by a snare lasso/loop 862 and thefilter 860 is retrieved into aretrieval catheter 863, as illustrated. - FIGS. 207 to 212 illustrate an embodiment in which a
filter 870 is used which has a partialtubular member 871 but the guidewire does not extend through the tubular member. This arrangement is similar to that of FIGS. 195 to 201 above and like parts are assigned the same reference numerals. The snare loop is in this case free of the guidewire and may be more easily manipulated. In both cases the snare loop may be rendered radiopaque to facilitate snaring with the filter for retrieval. - Further retrieval devices are illustrated in FIGS. 213 to 218 in which the retrieval devices have
arms 950 which open out when anouter sheath 951 is retracted and thus create a large inlet mouth which can readily trap the filter frame, particularly if radiopaque features such as marker bonds are used. When thearms 950 are in position distal to the snare feature of the frame/filter the arms are closed again, for example by re-advancing asheath 951 which collapses thearms 950 and trapstether feature 952 of the filter, for example behind a step or tooth on the arm(s). - Referring to FIGS. 219 to 224 the filter frame may have a retrieval feature such as a
nodule 960 which may be engaged by a suitable snare such as a snare loop or lasso 961 which is then tightened or simply pulled back to collapse the frame and retrieve the filter. The centeringtip 962 may be used to assist guiding of the snare loop. - Various alternative filter designs with an integral snare feature are possible. For example, in
FIGS. 225 and 226 the filter frame has a projectingarm 970 which may be engaged by a snare. - An
expandable engagement member 971 may be used to catch a drawstring type arrangement 972 (FIGS. 227, 228 ) or to catch internal wires/tethers/fibers/strings of the filter (FIGS. 229, 230 ). - Referring to
FIGS. 231 and 232 there is illustrated the size of asnare 990 to snare afilter 991. The snare engagable features of the filter in this case are provided byindents 992 in the support arms over which thesnare loop 990 is engaged. - The snaring of a filter of any type is illustrated in FIGS. 233 to 237. In this case the
filter 995 is positioned distal to astent 996 and asnare loop 997 is advanced through the stent to engage the filter as illustrated, allowing the filter to be at least partially collapsed for retrieval. - In
FIGS. 238 and 239 there is illustrated the snaring of afilter 1 as illustrated inFIG. 1 using asnare loop 998. - A further
embolic protection filter 700 according to the invention is illustrated inFIGS. 240 and 241 . Thefilter 700 comprises a collapsiblefilter support structure 701 and acollapsible filter body 702. - In the expanded, deployed configuration of
FIG. 240 , thesupport structure 701 does not have an inner tubular member to define a guidewire lumen for passing a guidewire 703 through. When thefilter 700 is collapsed, the support structure collapses down into a smaller diameter tubular structure, as illustrated inFIG. 241 . In this collapsed configuration, thesupport structure 701 defines the guidewire lumen for the guidewire 703. In this manner thesupport structure 701 isolates thefilter body 702 from the guidewire 703, and thus prevents thefilter body 702 from becoming fixed to the guidewire 703 during delivery or retrieval of thefilter 700. - The
filter 700 may be retrieved using any suitable means, such as the hooked retrieval catheter (FIG. 242 ), in a manner similar to that described previously or the hooped retrieval catheter (FIG. 243 ), in a manner similar to that described previously. - If it is desired to remove the guidewire 703 from the
filter 700 and recross thefilter 700 with a second guidewire 704, the guidewire 704 may be threaded through one of the relatively large inlet openings 705 instead of through the relatively small proximal collar 706 of thesupport structure 701, as illustrated inFIG. 244 . This enables a faster and more convenient means of recrossing thefilter 700. - In addition, the distal collar 707 of the
filter support structure 701 is spaced proximally of the distal end of thefilter 700 to facilitate crossing of thefilter 700 with the second guidewire 704 without requiring the guidewire 704 to be threaded through the distal collar 707 (FIG. 244 ). - The
filter 700 can be retrieved after crossing thefilter 700 with the second guidewire 704 using any suitable means (FIGS. 245 and 246 ). - Referring to
FIGS. 247 and 248 , there is illustrated anotherembolic protection filter 710 according to the invention, which is similar to theembolic protection filter 700 ofFIGS. 240 and 241 , and similar elements inFIGS. 247 and 248 are assigned the same reference numerals. - The
filter 710 is longitudinally shorter than thefilter 700. In addition thefilter support structure 701 ends in an opendistal mouth 711 in thefilter 710 and no distal collar is provided in thefilter 710, as illustrated inFIG. 247 . - In the
filter 710, thefilter body 702 is isolated from the guidewire 703 by the collapsed filter support structure 701 (FIG. 248 ), in a manner similar to that described previously with reference toFIG. 241 . - The
filter 710 may be recrossed by the second guidewire 704 by threading the guidewire 704 through one of the relatively large inlet openings 705 (FIG. 249 ), in a manner similar to that described previously with reference toFIG. 244 . - Referring to FIGS. 252 to 256 the position of the
filter 1 in thevasculature 21 may be controlled by anabutment 200 on a guidewire 201. By engaging theabutment 200 with an abutment surface on thefilter 1, thefilter 1 is prevented from moving distally of theguidewire abutment 200. In this manner, the position of thefilter 1 in thevasculature 21 may be controlled, if necessary. - The
abutment 200 may be fixedly attached to the guidewire 201 by a suitable means, such as by crimping, before introducing the guidewire 201 into thevasculature 21. Alternatively theabutment 200 may be fixed to the guidewire 201 during deployment of thefilter 1. - As illustrated in
FIG. 257 thefilter 205 according to the invention may have atether 206 fixed to thefilter 205, extending proximally of thefilter 205. Thetether 206 may be used by a clinician to control the position of thefilter 205 in thevasculature 21 from a location externally of thevasculature 21. Thetether 206 may be in the form of a wire, and may be of any suitable material. - In use, the
filter 205 may be deployed over a guidewire 207. If appropriate or necessary, the guidewire 207 may then be withdrawn from thefilter 205 and thevasculature 21. Thetether wire 206 may then be used as a platform for advancing further devices through thevasculature 21, for example theretrieval catheter 20. - Referring to FIGS. 258 to 260, there is illustrated another embolic protection filter assembly 115 according to the invention. The assembly 115 comprises a filter and a receiver to guide the
guidewire 30 into theguidewire lumen 12. The receiver is provided, in this case, by an approach channel 116 for theguidewire 30 in the form of a lumen in a separate catheter 117. The catheter 117 has one or more inflatable balloons 118 at the distal end of the catheter 117. The shape and/or position of the balloons 118 is configured to ensure that the blood flow through thevasculature 21 will not be occluded upon inflation of the balloon(s) 118. In one case, the catheter 117 has three balloons 118 spaced circumferentially around the catheter 117, as illustrated inFIG. 261 . In another case, the catheter 117 has four circumferentially spaced balloons 118 (FIG. 262 ). - In use, the catheter 117 is introduced into the
vasculature 21 and advanced through thevasculature 21 until the catheter distal end is proximally adjacent the filter 1 (FIG. 56 ). The balloon 118 is then inflated until the balloon 118 engages the wall of thevasculature 21. By engaging the balloon 118 with the wall of thevasculature 21, the catheter 117 is spaced from the wall of thevasculature 21 to assist in locating the catheter approach channel 116 centrally in thevasculature 21. Theguidewire 30 may then be introduced into the channel 116 and advanced through the catheter 117. Because the channel 116 is located centrally in thevasculature 21, theguidewire 30 is guided into theguidewire lumen 12 of thefilter 1 as it passes out of the distal end of the channel 116. The balloon 118 may be deflated to a low profile configuration during introduction and withdrawal of the catheter 117 from thevasculature 21. - It will be appreciated that any number of seals may be provided to prevent embolic material passing through the guidewire lumen or the guidewire aperture, and the seals may be positioned at any suitable point along the guidewire lumen or the guidewire aperture.
- It will further be appreciated that the receiver may be configured to guide a docking device in the form of a coupling member, such as those described previously, towards the filter for coupling to the filter. In such a manner, the receiver may be used to assist retrieval of the filter. The coupling means may be achieved by numerous alternatives, for example male-female inter-engagement, or magnetic coupling, or hook and eyelet means.
-
FIG. 263 illustrates anotherretrieval catheter 600 according to the invention. The coupling member 24, in this case, has atubular extension part 601 which extends distally of thehooks 100. In use, thetubular extension 601 may be extended through an embolic protection filter 602 to be retrieved, as illustrated inFIG. 264 . Thetubular extension 601 in this way defines the guidewire lumen 603 through the filter 602 through which a guidewire 604 may be passed. - The
retrieval catheter 600 is particularly suitable for retrieving filters, such as the filter 602 which do not have an inner tubular member to define a guidewire lumen through the filter 602. Filters which do not have an inner tubular member are liable to becoming fixed against the guidewire 604 when the filter is collapsed down. When this occurs it is no longer possible to retrieve the filter while the guidewire remains in situ in the vasculature. - By defining the guidewire lumen 603 using the
tubular extension 601 of theretrieval catheter 600, this serves to isolate the collapsing filter 602 from the guidewire 604, and thus prevents the filter 602 from becoming fixed to the guidewire 604. - The
tubular extension 601 may be advanced to the distal end of the filter 602 before retrieving the filter 602 into the catheter body 23, as illustrated inFIG. 85 . - Alternatively the
tubular extension 601 may be advanced until thetubular extension 601 is distally of the distal end of the filter 602 before retrieving the filter 602 into the catheter body 23. - The invention is not limited to the embodiments hereinbefore described, with reference to the accompanying drawings, which may be varied in construction and detail.
Claims (14)
1. An embolic protection filter for deployment in a vasculature, the filter having an inlet end and an outlet end, the inlet end having one or more inlet openings sized to allow blood and embolic material enter the filter and the outlet end of the filter having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter;
the filter being movable between a collapsed configuration for movement through a vasculature, and an outwardly extended configuration for deployment in a vasculature;
the filter including a retrieval mechanism whereby the filter can be urged to the collapsed configuration from the outwardly extended configuration.
2. The embolic protection filter as claimed in claim 1 , wherein the retrieval mechanism is a drawstring retrieval mechanism
3. The embolic protection filter as claimed in claim 1 , wherein the drawstring retrieval mechanism has a mesh configuration.
4. The embolic protection filter as claimed in claim 2 , wherein the drawstring retrieval mechanism is near the inlet end of the filter.
5. A method for the capture and removal of embolic material from a vasculature during an interventional procedure comprising the steps of:
providing a collapsible embolic protection filter including a drawstring removal mechanism having a collapsed configuration for delivery of the filter, and a deployed outwardly extending configuration;
advancing a guidewire through a vasculature;
crossing a desired treatment location with the guidewire;
deploying the filter distal to the treatment location;
carrying out an interventional procedure at the treatment location, embolic material generated during the treatment procedure being captured by the deployed filter;
advancing a retrieval device comprising a centering catheter and a retrieval catheter;
engaging the drawstring removal mechanism with the centering catheter;
collapsing the filter;
drawing the filter into retrieval catheter; and
withdrawing the retrieval device and the filter from the vasculature.
6. The method according to claim 4 , further including the step of withdrawing the guidewire prior to collapsing the filter.
7. The method according to claim 4 , wherein the filter further includes a guiding member associated with a proximal portion of the embolic protection filter, the guiding member being configured to receive and guide a guidewire through at least a portion of the filter.
8. A method for the capture and removal of embolic material from a vasculature, comprising the steps of:
advancing a first guidewire through the vasculature to a position distal an area to be treated;
advancing an embolic protection filter disposed about said guidewire to a position distal the area to be treated;
causing the embolic protection filter to expand from a contracted position to an expanded position generally in apposition with the vasculature; and
withdrawing the guidewire proximally through the embolic protection filter.
9. The method according to claim 7 , further including the steps of performing a medical procedure and advancing a filter retrieval catheter, the filter retrieval catheter configured to engage a portion of the filter and cause the filter to be moved from the expanded position to the contracted position.
10. The method according to claim 7 , further comprising the step of exchanging the first guidewire with a second guidewire, the second guidewire having mechanical properties different than that of the first guidewire.
11. The method according to claim 8 , wherein the filter is provided with either recesses or protrusions and the retrieval catheter is configured with the complementary coupling member.
12. The method according to claim 7 , further including the step of advancing a second guidewire in conjunction with advancing the first guidewire, wherein the second guidewire is not coupled to the filter.
13. The method according to claim 7 , wherein the first guidewire is configured to be moved independently of the filter.
14. The method according to claim 7 , further including the steps of performing a medical procedure,
advancing the guidewire through the filter, and
advancing a filter retrieval catheter over the guidewire, the filter retrieval catheter configured to engage a portion of the filter and cause the filter to be moved from the expanded position to the contracted position.
Priority Applications (1)
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US11/613,432 US20070244504A1 (en) | 2002-03-05 | 2006-12-20 | Embolic protection system |
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US11/613,432 US20070244504A1 (en) | 2002-03-05 | 2006-12-20 | Embolic protection system |
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Also Published As
Publication number | Publication date |
---|---|
ES2295608T3 (en) | 2008-04-16 |
ATE369088T1 (en) | 2007-08-15 |
DE60315425D1 (en) | 2007-09-20 |
AU2003209965A1 (en) | 2003-09-16 |
EP1482860A1 (en) | 2004-12-08 |
WO2003073961A1 (en) | 2003-09-12 |
US20140142609A1 (en) | 2014-05-22 |
ATE378019T1 (en) | 2007-11-15 |
US20030212429A1 (en) | 2003-11-13 |
DE60315425T2 (en) | 2008-06-26 |
EP1482861A1 (en) | 2004-12-08 |
DE60317474T2 (en) | 2008-10-02 |
EP1482860B1 (en) | 2007-11-14 |
AU2003209966A1 (en) | 2003-09-16 |
WO2003073962A1 (en) | 2003-09-12 |
EP1482861B1 (en) | 2007-08-08 |
US20070060946A1 (en) | 2007-03-15 |
DE60317474D1 (en) | 2007-12-27 |
US7144408B2 (en) | 2006-12-05 |
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