US20050216053A1 - Guidewire apparatus for temporary distal embolic protection - Google Patents
Guidewire apparatus for temporary distal embolic protection Download PDFInfo
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- US20050216053A1 US20050216053A1 US11/130,727 US13072705A US2005216053A1 US 20050216053 A1 US20050216053 A1 US 20050216053A1 US 13072705 A US13072705 A US 13072705A US 2005216053 A1 US2005216053 A1 US 2005216053A1
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- Prior art keywords
- core wire
- shaft
- distal end
- filter
- guidewire
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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
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12027—Type of occlusion
- A61B17/1204—Type of occlusion temporary occlusion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
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- 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
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M25/09016—Guide wires with mandrils
- A61M25/09025—Guide wires with mandrils with sliding mandrils
-
- A—HUMAN NECESSITIES
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- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
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- A—HUMAN NECESSITIES
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- 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
- A61B2017/22038—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 with a guide wire
-
- 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
- A61B2017/22038—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 with a guide wire
- A61B2017/22045—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 with a guide wire fixed to the catheter; guiding tip
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- 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
- A61F2002/015—Stop means therefor
-
- 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
- A61F2230/0063—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
- A61F2230/0071—Three-dimensional shapes spherical
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09008—Guide wires having a balloon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09175—Guide wires having specific characteristics at the distal tip
- A61M2025/09183—Guide wires having specific characteristics at the distal tip having tools at the distal tip
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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
- A61M25/1011—Multiple balloon catheters
- A61M2025/1015—Multiple balloon catheters having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
Abstract
A guidewire apparatus for use during percutaneous catheter interventions, such as angioplasty or stent deployment. A protection element comprising a filter or an occluder is mounted near the distal end of a steerable guidewire, which guides a therapeutic catheter. The guidewire apparatus comprises a hollow shaft movably disposed about a core wire and, optionally, a slippery liner interfitted there between. The shaft and core wire control relative displacement of the ends of the protection element, causing transformation of the protection element between a deployed configuration and a collapsed configuration.
Description
- This patent application is a continuation-in-part of U.S. patent application Ser. No. 09/918,441 to Douk et al. filed Jul. 27, 2001, which is a continuation-in-part of U.S. patent application Ser. No. 09/824,832 to Douk et al. filed Apr. 3, 2001 entitled “Temporary Intraluminal Filter Guidewire and Methods of Use.”
- The present invention relates generally to intraluminal devices for capturing particulate in the vessels of a patient. More particularly, the invention relates to a filter or an occluder for capturing emboli in a blood vessel during an interventional vascular procedure, then removing the captured emboli from the patient after completion of the procedure. Furthermore, the invention concerns a filter or an occluder mounted on a guidewire that can also be used to direct an interventional catheter to a treatment site within a patient.
- A variety of treatments exists for dilating or removing atherosclerotic plaque in blood vessels. The use of an angioplasty balloon catheter is common in the art as a minimally invasive treatment to enlarge a stenotic or diseased blood vessel. When applied to the vessels of the heart, this treatment is known as percutaneous transluminal coronary angioplasty, or PTCA. To provide radial support to the treated vessel in order to prolong the positive effects of PTCA, a stent may be implanted in conjunction with the procedure.
- Thrombectomy is a minimally invasive technique for removal of an entire thrombus or a sufficient portion of the thrombus to enlarge the stenotic or diseased blood vessel and may be accomplished instead of a PTCA procedure. Atherectomy is another well-known minimally invasive procedure that mechanically cuts or abrades a stenosis within the diseased portion of the vessel. Alternatively, ablation therapies use laser or RF signals to superheat or vaporize a thrombus within the vessel. Emboli loosened during such procedures may be removed from the patient through the catheter.
- During each of these procedures, there is a risk that emboli dislodged by the procedure will migrate through the circulatory system and cause ischaemic events, such as infarction or stroke. Thus, practitioners have approached prevention of escaped emboli through use of occlusion devices, filters, lysing, and aspiration techniques. For example, it is known to remove the embolic material by suction through an aspiration lumen in the treatment catheter or by capturing emboli in a filter or occlusion device positioned distal of the treatment area.
- Features, aspects and advantages of the present invention will become better understood with reference to the following description, appended claims, and accompanying drawings where:
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FIG. 1 is an illustration of a filter system in accordance with the invention deployed within a blood vessel; -
FIG. 2 is an illustration of a filter system in accordance with the invention deployed within a portion of the coronary arterial anatomy; -
FIG. 3 is an illustration of a prior art expandable mesh device, shown with the mesh in a collapsed configuration; -
FIG. 4 is an illustration of a prior art expandable mesh device, shown with the mesh in a deployed configuration; -
FIG. 5 is a longitudinal sectional view of a first guidewire embodiment in accordance with the invention; -
FIG. 6 is a longitudinal sectional view of a second guidewire embodiment in accordance with the invention; -
FIG. 7 is a cross-sectional view of the second guidewire embodiment taken along the lines 7-7 ofFIG. 6 ; -
FIG. 8 is a modified form of the cross-sectional view shown inFIG. 7 ; -
FIG. 9 is another modified form of the cross-sectional view shown inFIG. 7 ; -
FIG. 10 is an enlarged supplementary view of a portion ofFIG. 8 , which has been modified to illustrate alternative embodiments of the invention; -
FIG. 11 is a longitudinal sectional view of a segment of a hollow shaft and liner in accordance with the invention; -
FIG. 12 is a partially sectioned longitudinal view of a third guidewire embodiment in accordance with the invention; and -
FIG. 13 is a partially sectioned longitudinal view of a fourth guidewire embodiment in accordance with the invention; -
FIG. 14 is a alternative form of the fourth guidewire embodiment shown inFIG. 13 . - The guidewire apparatus of the invention includes a protection element comprising a filter or an occluder mounted near the distal end of a steerable guidewire, which guides a therapeutic catheter. The guidewire apparatus comprises a hollow shaft movably disposed about a core wire and, optionally, a slippery liner interfitted there between. The shaft and core wire control relative displacement of the ends of the protection element, causing transformation of the protection element between a deployed configuration and a collapsed configuration.
- The present invention is a guidewire apparatus for use in minimally invasive procedures. While the following description of the invention relates to vascular interventions, it is to be understood that the invention is applicable to other procedures where the practitioner desires to capture embolic material that may be dislodged during the procedure. Intravascular procedures such as PTCA or stent deployment are often preferable to more invasive surgical techniques in the treatment of vascular narrowings, called stenoses or lesions. With reference to
FIGS. 1 and 2 , deployment of balloonexpandable stent 5 is accomplished by threadingcatheter 10 through the vascular system of the patient untilstent 5 is located within a stenosis at predeterminedtreatment site 15. Once positioned,balloon 11 ofcatheter 10 is inflated to expandstent 5 against the vascular wall to maintain the opening. Stent deployment can be performed following treatments such as angioplasty, or during initial balloon dilation of the treatment site, which is referred to as primary stenting. -
Catheter 10 is typically guided totreatment site 15 by a guidewire. In cases where the target stenosis is located in tortuous vessels that are remote from the vascular access point, such ascoronary arteries 17 shown inFIG. 2 , a steerable guidewire is commonly used. According to the present invention, a guidewire apparatus generally guidescatheter 10 totreatment site 15 and includes a distally disposed protection element to collect embolic debris that may be generated during the procedure. Various embodiments of the invention will be described as either filter guidewires or occluder guidewires. However, it is to be understood that filters and occluders are interchangeable types of protection elements among the inventive structures disclosed. The invention is directed to embolic protection elements wherein relative movement of the ends of the protection element either causes or accompanies transformation of the element between a collapsed configuration and an expanded, or deployed configuration. Such transformation may be impelled by external mechanical means or by self-shaping memory (either self-expanding or self-collapsing) within the protection element itself The protection element may be self-expanding, meaning that it has a mechanical memory to return to the expanded, or deployed configuration. Such mechanical memory can be imparted to the metal comprising the element by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy such as a nickel-titanium (nitinol) alloy. - Filter guidewires in accordance with the invention include distally disposed
filter 25, which may comprise a tube formed by braided filaments that define pores and have at least one proximally-facing inlet opening 66 that is substantially larger than the pores. Alternative types of filters may be used infilter 25, such as filter assemblies that include a porous mesh mounted to expandable struts. Optionally, adding radiopaque markers tofilter ends FIG. 12 , can aid in fluoroscopic observation offilter 25 during manipulation thereof. Alternatively, to enhance visualization of braidedfilter 25 under fluoroscopy, at least one of the filaments may be a wire having enhanced radiopacity compared to conventional non-radiopaque wires suitable for braidingfilter 25. At least the majority of braidingwires forming filter 25 should be capable of being heat set into the desired filter shape, and such wires should also have sufficient elastic properties to provide the desired self-expanding or self-collapsing features. Stainless steel and nitinol monofilaments are suitable for braidingfilter 25. A braiding wire having enhanced radiopacity may be made of, or coated with, a radiopaque metal such as gold, platinum, tungsten, alloys thereof, or other biocompatible metals that, compared with stainless steel or nitinol, have a relatively high X-ray attenuation coefficient. One or more filaments having enhanced radiopacity may be inter-woven with non-radiopaque wires, or allwires comprising filter 25 may have the same enhanced radiopacity. - In accordance with the invention, maintaining
filter 25 in a collapsed configuration during introduction and withdrawal offilter guidewire 20 does not require a control sheath that slidinglyenvelops filter 25. Thus, this type of device is sometimes termed as “sheathless.” Known types of sheathless vascular filter devices are operated by a push-pull mechanism that is also typical of other expandable braid devices, as shown inFIGS. 3 and 4 . Prior artexpandable mesh device 30 includescore wire 32 andhollow shaft 34 movably disposed there about. Tubular mesh, or braid 36 surroundscore wire 32 and has a braid distal end fixed to core wiredistal end 40 and a braid proximal end fixed to shaftdistal end 41. To expandbraid 36,core wire 32 is pulled andshaft 34 is pushed, as shown byarrows FIG. 4 . The relative displacement ofcore wire 32 andshaft 34 moves the ends ofbraid 36 towards each other, forcing the middle region ofbraid 36 to expand. To collapsebraid 36,core wire 32 is pushed andshaft 34 is pulled, as shown byarrows FIG. 3 . This reverse manipulation draws the ends ofbraid 36 apart, pulling the middle region ofbraid 36 radially inward towardcore wire 32. - Referring now to
FIG. 5 , in a first embodiment of the invention, filter guidewire 20 includescore wire 42 and flexibletubular tip member 43, such as a coil spring, fixed around the distal end ofcore wire 42. Thin wires made from stainless steel and/or one of various alloys of platinum are commonly used to make coil springs for such use in guidewires.Core wire 42 can be made from shape memory metal such as nitinol, or a stainless steel wire, and is typically tapered at its distal end. For treating small caliber vessels such as coronary arteries,core wire 42 may measure about 0.15 mm (0.006 inch) in diameter. - In
filter guidewire 20,hollow shaft 44 is movably disposed aroundcore wire 42, and includes relatively stiffproximal portion 46 and relatively flexibledistal portion 48.Proximal portion 46 may be made from thin walled stainless steel tubing, usually referred to as hypo tubing, although other metals, such as nitinol, can be used. Various metals or polymers can be used to make relatively flexibledistal portion 48. One appropriate material for this element is thermoset polyimide (PI) tubing, available from sources such as HV Technologies, Inc., Trenton, Ga., U.S.A. The length ofdistal portion 48 may be selected as appropriate for the intended use of the filter guidewire. In one example,portion 48 may be designed and intended to be flexible enough to negotiate tortuous coronary arteries, in which case the length ofportion 48 may be 15-35 cm (5.9-13.8 inches), or at least approximately 25 cm (9.8 inches). In comparison to treatment of coronary vessels, adaptations of the invention for treatment of renal arteries may require a relatively shorterflexible portion 48, and neurovascular versions intended for approaching vessels in the head and neck may require a relatively longerflexible portion 48. - When filter guidewire 20 is designed for use in small vessels,
shaft 44 may have an outer diameter of about 0.36 mm (0.014 inch). The general uniformity of the outer diameter may be maintained by connectingproximal portion 46 anddistal portion 48 with lap joint 49. Lap joint 49 may use any suitable adhesive such as cyanoacrylate instant adhesives from Loctite Corporation, Rocky Hill, Conn., U.S.A., or Dymax Corporation, Torrington, Conn., U.S.A. Lap joint 49 can be formed by any conventional method such as reducing the wall thickness ofproximal portion 46 in the region of joint 49, or by forming a step-down in diameter at this location with negligible change in wall thickness, as by swaging. - Expandable
tubular filter 25 is positioned generally concentrically withcore wire 42, and is sized such that when it is fully deployed, as shown inFIGS. 1 and 2 , the outer perimeter offilter 25 will contact the inner surface of the vessel wall. The surface contact is maintained around the entire vessel lumen to prevent any emboli from slippingpast filter 25. Cyanoacrylate adhesive may be used to secure filterdistal end 27 to tipmember 43, and to secure filterproximal end 29 near the distal end ofshaft 44. As shown inFIGS. 12 and 13 , radiopaque marker bands, such as platinum rings, can be incorporated into the adhesive joints securing filter ends 27, 29 respectively to tipmember 43 andshaft 44.Filter 25 is deployed by advancing, or pushingshaft 44 relative tocore wire 42 such that filter distal and proximal ends 27, 29 are drawn toward each other, forcing the middle, or central section offilter 25 to expand radially.Filter 25 is collapsed by withdrawing, or pullingshaft 44 relative tocore wire 42 such that filter distal and proximal ends 27, 29 are drawn apart from each other, forcing the middle, or central section offilter 25 to contract radially. -
Transition sleeve 45 is fixed aboutcore wire 42 and is slidably located within the distal end of flexibledistal portion 48 ofhollow shaft 44.Transition sleeve 45 may be made of polyimide tubing similar to that used indistal portion 48 and extends distally there from. By partially filling the annular space betweencore wire 42 andshaft 44, and by contributing additional stiffness over its length,sleeve 45supports core wire 42 and provides a gradual transition in overall stiffness of filter guidewire 20 adjacent the distal end ofshaft 44.Transition sleeve 45 is fixed tocore wire 42 with adhesive such as cyanoacrylate, such that relative displacement betweenshaft 44 andcore wire 42 causes corresponding relative displacement betweenshaft 44 andsleeve 45. The length and mounting position ofsleeve 45 are selected such thatsleeve 45 spans the distal end ofshaft 44 regardless of the configuration offilter 25 and the corresponding position ofshaft 44 relative tocore wire 42. When constructed as described above, filter guidewire 20 provides the functions of a temporary filter combined with the performance of a steerable guidewire. -
FIG. 6 depicts a second embodiment of the invention in which filter guidewire 120 incorporates a number of elements similar to the elements that make upfilter guidewire 20. Such similar elements will be identified with the same reference numerals throughout the description of the invention.Filter guidewire 120 includescore wire 142 and flexibletubular tip member 43 fixed around the distal end ofcore wire 142, similar to the arrangement ofguidewire 20, supra.Hollow shaft 144 is movably disposed aroundcore wire 142 and is comparable, throughout its length, to relatively stiffproximal portion 46 offilter guidewire 20.Filter 25 is positioned generally concentrically withcore wire 142. Filterdistal end 27 is fixedly coupled totip member 43, and filterproximal end 29 is fixedly coupled near the distal end ofshaft 144. - Optionally, a portion of
core wire 142 within the proximal end ofshaft 144 has one ormore bends 160 formed therein. The amplitude, or maximal transverse dimension ofbends 160 is selected such that the bent portion ofcore wire 142 fits, with interference, withinshaft 144. The interference fit provides sufficient friction to holdcore wire 142 andshaft 144 in desired axial positions relative to each other, thereby controlling the shape offilter 25, as described supra with respect to filterguidewire 20. - In
filter guidewire 120,liner 145 is interfitted as a low-friction axial bearing in the annular space betweencore wire 142 andshaft 144. With respect to the three coaxially arranged elements, the selected dimensions and the stack-up of dimensional tolerances will determine howliner 145 functions during the push-pull operation ofcore wire 142 withinshaft 144. - For example,
FIG. 7 depicts a cross-section of filter guidewire 120 in which there is radial clearance between linerinner surface 150 andcore wire 142, and there is also radial clearance between linerouter surface 151 and the inner wall ofshaft 144. In this arrangement,liner 145 is radially free-floating in the annular space betweencore wire 142 andshaft 144. The length ofliner 145 is selected such that it also “floats” axially alongcore wire 142. The axial movement ofliner 145 alongcore wire 142 is limited proximally by a stop formed at the engagement ofbends 160 with the inner wall ofshaft 144.Tip member 43 limits the axial distal movement ofliner 145 alongcore wire 142. The radial and axial flotation ofliner 145 infilter guidewire 120 provides an axial bearing wherein the components with the lesser relative coefficient of friction can slide against each other. For example, if the coefficient of friction between linerinner surface 150 andcore wire 142 is less than the coefficient of friction between linerouter surface 151 and the inner wall ofshaft 144, thenliner 145 will remain longitudinally fixed withinshaft 144, and push-pull action will causecore wire 142 to slide withinliner 145. Conversely, if the coefficient of friction between linerinner surface 150 andcore wire 142 is greater than the coefficient of friction between linerouter surface 151 and the inner wall ofshaft 144, thenliner 145 will remain longitudinally fixed aboutcore wire 142, and push-pull action will causeshaft 144 to slide overliner 145. The relative coefficients of friction for the movable components of the guidewire assembly may be designed-in by selection of materials and/or coatings, as will be described infra. Alternatively, the degree of sliding friction may result from unplanned events, such as the formation of thrombus on one or more component surfaces or embolic debris entering the annular space(s) there between. -
FIG. 8 depicts a modified form of the cross-sectional view shown inFIG. 7 in whichliner 145′ is fitted against the inner wall ofshaft 144, leaving radial clearance only between linerinner surface 150′ andcore wire 142.FIG. 9 depicts another modified form of the cross-sectional view shown inFIG. 7 in whichliner 145″ is fitted againstcore wire 142, leaving radial clearance only between linerouter surface 151′ and the inner wall ofshaft 144. - When filter guidewire 120 is designed for use in small vessels,
shaft 144 may have an outer diameter of about 0.36 mm (0.014 inch), andcore wire 142 may measure about 0.15 mm (0.006 inch) in diameter.Shaft 144, which can be made from hypo tubing, may have an inside diameter of about 0.23 mm (0.009 inch). Forliner 145 to “float” in an annular space betweencore wire 142 andshaft 144 with such dimensions, linerouter surface 151 may measure about 0.22 mm (0.0088 inch) in diameter and linerinner surface 150 may measure about 0.18 mm (0.0069 inch) in diameter.Liner 145′ does not require clearance around its outside diameter, because it is fitted against the inner wall ofshaft 144. As compared toliner 145,liner 145′ may have a greater wall thickness, and linerinner surface 150′ may have a similar inner diameter of about 0.18 mm (0.0069 inch).Liner 145″ does not require inside clearance because it is fitted againstcore wire 142. As compared toliner 145,liner 145″ may also have greater wall thickness, and linerouter surface 151′ may have a similar outer diameter of about 0.22 mm (0.0088 inch). -
Liners liners - Thermoset polyimide (PI) is an example of a liner material that may be selected for properties other than its coefficient of friction. PI tubing is noted for its ability to be formed with tight dimensional tolerances because it is typically formed by building up several layers of cured PI coating around a solid glass core, which is removed by chemical etching. One method of creating a slippery surface on PI tubing is to add a fluoropolymer filler, such as PTFE or FEP, to the PI coating to form one or more low-friction layers at the desired surface(s). Such polyimide/fluoropolymer composite tubing is available from MicroLumen, Inc., Tampa, Fla., U.S.A.
FIG. 10 illustrates a modified form of the invention wherein the inner surface ofliner 145′ compriseslubricious coating 150′. Also shown inFIG. 10 isslippery coating 155, which may be applied tocore wire 142 in conjunction with, or instead of, a slippery inner surface ofliners - Another example of a liner material that may be selected for properties other than its coefficient of friction is a block copolymer thermoplastic such as polyethylene block amide (PEBA). Although a slippery coating may be applied to this material, alternatively, its coefficient of friction may be reduced by polymerizing the surface with plasma. Plasma-aided surface functionalization to achieve high lubricity is described in U.S. Pat. No. 4,693,799 (Yanagihara et al.), and plasma surface modification is available from AST Products, Inc., Billerica, Mass., U.S.A. Plasma treated PEBA may be substituted for PTFE in liners to make use of improved physical properties, including the ability to be plastically extruded.
-
FIG. 11 depicts a variant ofliner 145′ disposed withinhollow shaft 144. In this example,liner 145′ comprises a coiled filament, which may be plastic, metal, or coated or surface-treated forms of either material. The coiled variant may be applied to any ofliners Hollow tube 144 andcore wire 142 will only touch coiledliner 145′ on helical curvilinear portions of the outer and inner surfaces, respectively. If coiledliner 145′ is made with an outer diameter larger than the inner diameter ofhollow tube 144, thenliner 145′ will generally hold itself in assembled position against the inner diameter ofhollow tube 144. Similarly, ifliner 145″ is made as a coil with an inner diameter smaller than the diameter ofcore wire 142, thenliner 145″ will generally hold itself in assembled position aroundcore wire 142. -
FIG. 12 depicts a third embodiment of the invention in which filter guidewire 220 incorporates several elements that are similar to the components offilter guidewires Core wire 242 is disposed withinliner 145, which is disposed withinhollow shaft 144.Core wire 242 is comprised ofproximal section 256 and separatedistal section 258, which extends distally fromshaft 144. Sliding clearance(s) may be formed between different elongate movable components, as described supra and as shown inFIGS. 7, 8 and 9. Ifliner 145 is fitted againstcore wire 242, as shown inFIG. 9 , thenliner 145 will comprise separate proximal and distal sections (not shown) corresponding to core wireproximal section 256 and core wiredistal section 258. Flexibletubular tip member 43 is fixed around the distal end of core wiredistal section 258.Transition sleeve 270 is slidably disposed about a distal portion ofhollow shaft 144 and extends distally there from to a fixed coupling location ontip member 43.Filter 25 is self-expanding and is positioned generally concentrically with the distal portion ofshaft 144. Filterdistal end 27 is fixedly coupled totransition sleeve 270, and filterproximal end 29 is fixedly coupled toshaft 144 adjacent the distal portion thereof. - Prior to negotiating vascular anatomy with
filter guidewire 220, filter 25 may be collapsed by advancing core wireproximal section 256 withinshaft 144 andliner 145 until the distal end ofproximal section 256 abuts the proximal end ofdistal section 258, formingcontinuous core wire 242. Continued advancement ofcore wire 242 throughshaft 144 andliner 145 will displacetip member 43 distally away fromshaft 144. The axial translation oftip member 43 will drawsleeve 270 distally along, but not off of, the distal portion ofhollow shaft 144. The relative longitudinal movement ofsleeve 270 with respect toshaft 144 causes filterdistal end 27 to move away from filterproximal end 29, transformingfilter 25 from its expanded configuration to its collapsed configuration. Optionally, filter guidewire 220 may includebends 160 in core wire proximal section 256 (not shown) to provide frictional engagement betweencore wire 242 and the proximal end ofshaft 144. As described supra, the optional friction mechanism thus created can holdcore wire 242 in a selected axial position withinshaft 144, thereby retainingfilter 25 in the collapsed configuration. - Withdrawing core wire
proximal section 256 proximally throughshaft 144 andliner 145 allowsfilter 25 to transform itself towards the expanded configuration by drawing filter ends 27, 29 closer together. The self-transformation offilter 25 towards the expanded configuration causes simultaneous proximal movement ofsleeve 270,tip member 43 and core wiredistal section 258 relative toshaft 144. The self-expansion offilter 25 stops when a)filter 25 reaches its pre-formed expanded configuration, orb) filter 25 encounters a radial constraint, such as apposition with a vessel wall in a patient, or c) filter 25 encounters an axial constraint, such as the proximal end ofsleeve 270 contacting filterproximal end 29, as depicted inFIG. 12 . After self-expansion offilter 25 has stopped, any further withdrawal of core wireproximal section 256 will cause it to separate from core wiredistal section 258, thereby allowing core wiredistal section 258,tip member 43, andsleeve 270 to move freely with respect to the distal end ofhollow shaft 144. In this configuration, core wireproximal section 256 will not interfere with self-expansion or self-adjustment offilter 25 in its apposition with the vessel wall. -
Transition sleeve 270 may be made of polyimide tubing and may be fixed to tipmember 43 and to filterdistal end 27 with adhesive, such as cyanoacrylate. The length and mounting position ofsleeve 270 are selected such thatsleeve 270 always surrounds the distal end ofshaft 144, regardless of the configuration and length offilter 25.Sleeve 270 can supportcore wire 242 across the longitudinal gap between the distal end ofshaft 144 and the proximal end oftip member 43. By contributing additional stiffness over its length,sleeve 270 also provides a transition in overall stiffness of filter guidewire 220 adjacent the distal end ofshaft 144. -
FIG. 13 depicts a fourth embodiment of the invention in which occluder guidewire 320 incorporates several elements that are similar to the components offilter guidewires Core wire 342 is disposed withinliner 145, which is disposed withinhollow shaft 144. Alternatively,liners 145′ or 145″ may be substituted forliner 145 such that different sliding clearance(s) may be formed between different elongate movable components, as described supra and as shown inFIGS. 7, 8 and 9. Flexibletubular tip member 43 is fixed around the distal end ofcore 342.Transition sleeve 270 is slidably disposed about a distal portion ofhollow shaft 144 and extends distally there from to a sliding coupling location ontip member 43. Stop 381 protrudes radially outward from the proximal end oftip member 43, and stop 382 protrudes radially inward from the distal end oftransition sleeve 270.Stops transition sleeve 270 from sliding proximally off oftip member 43. Stop 381 may comprise a portion oftip member 43, such as one or more enlarged turns at the proximal end of a coil spring. Alternatively, stop 381 may be created with metal or plastic elements, such as solder or polyimide bands. Stop 382 may comprise a portion oftransition sleeve 270, such as a rim or neck of reduced diameter formed at the distal end thereof. Alternatively, stop 382 may be created with metal or plastic elements, such as polyimide bands. -
Occluder 325 is self-expanding and is positioned generally concentrically with the distal portion ofshaft 144.Occluder 325 may comprise a tubular braid similar to filter 25, which is coated with an elastic material to render it non-porous. Alternatively,occluder 325 may include self-expanding struts (not shown) that support a non-porous elastic membrane, as known to those of ordinary skill in the art. A non-porous coating or membrane may be made from a variety of elastic materials, such as silicone rubber or a thermoplastic elastomer (TPE). Occluderdistal end 327 is fixedly coupled totransition sleeve 270, and occluderproximal end 329 is fixedly coupled toshaft 144 proximally adjacent the distal portion thereof. - In
occluder guidewire 320,occluder 325 may be collapsed by advancingcore wire 342 throughshaft 144 andliner 145, causingtip member 43 to translate withintransition sleeve 270 untilstop 381 engages stop 382, as shown inFIG. 13 . Continued advancement ofcore wire 342 throughshaft 144 andliner 145 will displacetip member 43 distally fromshaft 144, drawingsleeve 270 along, but not off of, the distal portion ofhollow shaft 144. The relative longitudinal movement ofsleeve 270 with respect toshaft 144 causes occluderdistal end 327 to move away from occluderproximal end 329, which transformsoccluder 325 from its expanded configuration to its collapsed configuration. Reversing the above manipulation, i.e.drawing core wire 342 proximally throughshaft 144 andliner 145, permits occluder 325 to expand itself. Self-expansion ofoccluder 325 will stop when one of several conditions is met, as described above with respect to self-expandingfilter 25 offilter guidewire 220. Thereafter, continued withdrawal ofcore wire 342 will drawtip member 43 proximally withintransition sleeve 270, creating axial separation (not shown) betweenstops transition sleeve 270, withstop 382, to slide freely alongtip member 43. In this configuration,core wire 342 andtip member 43 will not interfere with self-expansion or self-adjustment ofoccluder 325 in its apposition with the vessel wall. -
FIG. 13 illustrates the portion ofcore wire 342 withinhollow shaft 144 having a firstproximal segment 390, which also extends proximally fromhollow shaft 144. Firstproximal segment 390 is sized to fit slidingly withinhollow shaft 144, but without sufficient radial clearance forliners proximal segment 390 may comprise a major length ofcore wire 342, such that relatively short core wiredistal segment 391 is dimensioned to receiveliners core wire 342 may be about 175 cm, and the length of core wiredistal segment 391 may be about 15 to 25 cm. Alternatively, firstproximal segment 390 may have a relatively short length such that core wiredistal segment 391 and surroundingliners hollow shaft 144. - The transition in diameter between core wire
distal segment 391 and firstproximal segment 390 may occur asstep 398, which can limit the proximal slippage of free-floatingliner 145 alongcore wire 342. Optionally, occluder guidewire 320 may exclude any liner while still incorporating steppeddiameter core wire 342 shown inFIG. 13 . In such an arrangement, the annular space that would otherwise be occupied by a liner can provide enlarged clearance and accompanying reduced friction betweencore wire 342 andhollow shaft 144, especially when occluder guidewire 320 is curved through tortuous anatomy.Core wire 342 may also optionally include bends 160 (not shown) located distal to firstproximal segment 390. - In order to steer a distal protection guidewire in accordance with the invention through tortuous vasculature,
tip member 43 is typically bent or curved prior to insertion of the device, which should transmit to tipmember 43 substantially all of the rotation, or torque applied by the clinician at the proximal end of the device. It is most convenient for the physician to steer the device by grasping androtating shaft 144, and having such rotation imparted to tipmember 43, either directly or through the core wire. In distal protection guidewires of the instant invention, various design features reduce longitudinal friction between the hollow shaft and the core wire. These same friction-reducing features also reduce rotational friction between the hollow shaft and the core wire, which would otherwise be useful in transmitting rotation to steer the device. Infilter guidewires shaft 144 to tipmember 43 through the braided structure offilter 25, however this action is generally effective only whenfilter 25 is in the collapsed configuration. Inoccluder guidewire 320, occluderdistal end 327 is slidably connected to tipmember 43 throughtransition sleeve 270 such that torque cannot be transmitted fromshaft 144 to tipmember 43 throughoccluder 325. - It is therefore advantageous, as shown in
occluder guidewire 320, to include a torque-transmitting element, such astorque member 384.Torque member 384 can comprise metal or plastic filaments that form a hollow tube of counter wound spirals or a braid. To minimize bulk and stiffness,torque member 384 may include only a single filament in each of the clockwise and counter clockwise winding directions. The proximal end oftorque member 384 is bonded to the distal end ofshaft 144 and extends distally there from to surroundcore wire 342 over a relatively short distance. The distal end oftorque member 384 is bonded to the proximal end oftip member 43, or tocore wire 342 adjacent thereto. The braided, or spirally wound tubular structure oftorque member 384 permits it to transmit rotation forces betweenshaft 144 andtip member 43, and to do so at any length required to accommodate longitudinal displacement ofshaft 144 andtip member 43 during transformation ofoccluder element 325 between a collapsed configuration and an expanded configuration. -
FIG. 14 illustratesoccluder guidewire 320′, which incorporates an alternative torque-transmitting element. Core wiredistal segment 391′ includes flat 386, as may be formed thereon by grinding.Dimple 388 is formed inshaft 144′, as by controlled crimping, to extend through an opening inliner 145 and to slidably engage flat 386.Dimple 388 permits limited longitudinal displacement ofshaft 144′ andcore wire 342′ during transformation ofoccluder element 325 between a collapsed configuration and an expanded configuration.Dimple 388 engages with flat 386 to perform as a key and keyway arrangement, transmitting rotation betweenshaft 144′ andcore wire 342′. - In
occluder guidewire 320, secondproximal segment 392 is located proximally of firstproximal segment 390 and has an enlarged diameter approximating the outer diameter ofshaft 144.Reinforcement coil 396 surrounds firstproximal segment 390 between secondproximal segment 392 and the proximal end ofhollow shaft 144.Coil 396 has about the same outer diameter asshaft 144, and helps prevent kinking of the portion of firstproximal segment 390 that extends fromhollow shaft 144. Alternatively,FIG. 14 showsreinforcement coil 396′, which is formed as an integral, spirally cut section at the proximal end ofshaft 144′. The proximal end ofreinforcement coil 396′ is bonded to firstproximal segment 390, as by adhesive or solder, to effectively form secondproximal segment 392. Reinforcement coils 396 and 396′ can vary in length to accommodate longitudinal displacement ofshaft 144′ andcore wire 342′ during transformation ofoccluder element 325 between a collapsed configuration and an expanded configuration. - Third
proximal segment 394 is located proximally of secondproximal segment 392 and is adapted for engagement to a guidewire extension (not shown), as is well known to those of ordinary skill in the art of guidewires. Examples of guidewire extensions usable withoccluder guidewire 320 and other embodiments of the invention are shown in U.S. Pat. No. 4,827,941 (Taylor), U.S. Pat. No. 5,113,872 (Jahrmarkt et al.) and U.S. Pat. No. 5,133,364 (Palermo et al.) - To adjust and maintain the relative longitudinal and/or rotational positions of core wires and the surrounding hollow shafts in the various embodiments of the invention, a removable handle device (not shown) of a type familiar to those of skill in the art may be used. Such handle devices can have telescoping shafts with collet-type clamps that grip respectively the core wires and shafts in the various embodiments of guidewire apparatuses according to the present invention. The handle device can also serve as a steering handle, or “torquer” which is useful for rotating steerable-type guidewires that are incorporated in the instant invention.
- A method of using of a guidewire apparatus of the invention is described as follows. It should be noted that the example described infra is unnecessarily limited to a filter guidewire embodiment.
Filter guidewire 20, having self-expandingfilter 25 andhollow shaft 44 is provided, and advancing core wire 62 throughshaft 44 collapses filter 25. Withfilter 25 in the collapsed configuration, filter guidewire 20 is advanced into the patient's vasculature untilfilter 25 is beyond intendedtreatment site 15. Withdrawal of core wire 62 allowsfilter 25 to expand. Withfilter 25 deployed into contact with the vessel wall, a therapeutic catheter is advanced over filter guidewire 20 totreatment site 15, and therapy, such as balloon angioplasty, is performed. Any embolic debris generated during the therapy is captured infilter 25. After the therapy is completed, the therapeutic catheter is prepared for withdrawal, as by deflating the balloon, if so equipped. Advancing core wire 62 throughshaft 44 collapses filter 25. Finally, filter guidewire 20 and the therapeutic catheter can be withdrawn separately or together, along with collected embolic debris contained withinfilter 25. If an occluder guidewire of the invention were substituted for a filter guidewire in the above-described method, then aspiration of trapped embolic material would be performed with a separate catheter before collapsing the occluder element. - One benefit of the structures of
filter guidewires guidewire tip member 43 forms a fixed length tip of the device, regardless of the configuration offilter 25. Conversely, inoccluder guidewire 320, the tip length changes as occluderdistal end 327 slides alongtip member 43 during transformation ofoccluder 325 between expanded and collapsed configurations. The variable tip length ofoccluder guidewire 320 provides a short tip whenoccluder 325 is collapsed, but the tip needs to lengthen distally oftreatment site 15, if possible, during expansion ofoccluder 325. During deployment offilter guidewires treatment site 15. This is accomplished by the user holdingcore wires shafts Filter 25 can be maintained in a collapsed configuration by a frictionmechanism including bends 160, or by applying proximal tension toshafts proximal end 29 apart from filterdistal end 27. Releasing the tension onshafts filter 25 to expand by filterproximal end 29 translating distally towards filterdistal end 27. During this filter deployment, however, the distal tip does not need to move relative to filter 25 ortreatment area 15. - While the invention has been particularly shown and described with reference to the preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail may be made there in without departing from the spirit and scope of the invention. For example, the invention may be used in any intravascular treatment utilizing a guidewire where the possibility of loosening emboli may occur. Although the description herein illustrates angioplasty and stent placement procedures as significant applications, it should be understood that the present invention is in no way limited to those environments.
Claims (12)
1-13. (canceled)
14. The guidewire apparatus of claim 47 , wherein the torque-transmitting element is a filamentous tube having proximal and distal ends and a variable length to permit longitudinal displacement between the shaft and the core wire, the tube disposed about the core wire distal end at a location extending from the shaft distal end towards the tip member, the tube proximal end being fixed to the shaft distal end and the tube distal end fixedly connected to a proximal end of the tip member.
15. The guidewire apparatus of claim 47 , wherein the torque-transmitting element is a filamentous tube having proximal and distal ends and a variable length to permit longitudinal displacement between the shaft and the core wire, the tube disposed about the core wire distal end at a location extending from the shaft distal end towards the tip member, the tube proximal end being fixed to the shaft distal end and the tube distal end fixedly connected to the core wire adjacent to a proximal end of the tip member.
16. The guidewire apparatus of claim 47 , wherein the torque-transmitting element comprises a flat formed on the core wire and a corresponding dimple formed in the hollow shaft, the dimple being slidingly engaged with the flat to permit longitudinal displacement between the shaft and the core wire, the dimple being keyed with the flat for transmitting rotation forces from the hollow shaft to the core wire.
17-46. (canceled)
47. A guidewire apparatus comprising:
an elongate hollow shaft having an inner wall and proximal and distal ends;
a core wire movably disposed within the shaft and having a distal end extending there from;
a torque-transmitting element capable of transmitting rotation force from the hollow shaft to the core wire;
a flexible tip member fixed about the core wire distal end, and
a generally tubular protection element having a distal end coupled to the tip member and a proximal end coupled adjacent the shaft distal end, wherein relative longitudinal movement between the distal and proximal ends of the protection element accompanies a transformation of the protection element between a collapsed configuration and an expanded configuration.
48. The guidewire apparatus of claim 47 , further comprising:
a liner interfitted between the core wire and the shaft inner wall, the liner having an inner surface and an outer surface, wherein at least one of the surfaces has a low coefficient of friction.
49. The guidewire apparatus of claim 47 , further comprising:
a transition sleeve being slidably disposed about the shaft distal end and extending distally there from such that a sleeve distal end surrounds and couples with a proximal portion of the tip member, wherein the tubular protection element distal end is fixed to the transition sleeve.
50. The guidewire apparatus of claim 49 wherein the transition sleeve distal end is fixedly coupled with the tip member proximal portion.
51. The guidewire apparatus of claim 49 wherein the sleeve distal end is slidingly coupled about the tip member and restrained by stop members from sliding proximally off of the tip member.
52. The guidewire apparatus of claim 47 wherein the protection element is a filter.
53. The guidewire apparatus of claim 47 wherein the protection element is an occluder.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US11/130,727 US20050216053A1 (en) | 2001-04-03 | 2005-05-17 | Guidewire apparatus for temporary distal embolic protection |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
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US09/824,832 US6866677B2 (en) | 2001-04-03 | 2001-04-03 | Temporary intraluminal filter guidewire and methods of use |
US09/918,441 US6818006B2 (en) | 2001-04-03 | 2001-07-27 | Temporary intraluminal filter guidewire |
US10/099,399 US6911036B2 (en) | 2001-04-03 | 2002-03-15 | Guidewire apparatus for temporary distal embolic protection |
US11/130,727 US20050216053A1 (en) | 2001-04-03 | 2005-05-17 | Guidewire apparatus for temporary distal embolic protection |
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US10/099,399 Division US6911036B2 (en) | 2001-04-03 | 2002-03-15 | Guidewire apparatus for temporary distal embolic protection |
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US20050216053A1 true US20050216053A1 (en) | 2005-09-29 |
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US11/130,727 Abandoned US20050216053A1 (en) | 2001-04-03 | 2005-05-17 | Guidewire apparatus for temporary distal embolic protection |
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US10/099,399 Expired - Fee Related US6911036B2 (en) | 2001-04-03 | 2002-03-15 | Guidewire apparatus for temporary distal embolic protection |
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Also Published As
Publication number | Publication date |
---|---|
US20020169472A1 (en) | 2002-11-14 |
DE60318679T2 (en) | 2009-01-08 |
ATE383831T1 (en) | 2008-02-15 |
EP1344502A3 (en) | 2003-10-15 |
EP1459704A1 (en) | 2004-09-22 |
US6911036B2 (en) | 2005-06-28 |
JP2003265489A (en) | 2003-09-24 |
DE60318679D1 (en) | 2008-03-06 |
EP1459703A1 (en) | 2004-09-22 |
EP1459703B1 (en) | 2008-01-16 |
EP1459705A1 (en) | 2004-09-22 |
EP1344502A2 (en) | 2003-09-17 |
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