US20050049610A1 - Embolic protection device - Google Patents
Embolic protection deviceDownload PDFInfo
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- US20050049610A1 US20050049610A1US10/932,716US93271604AUS2005049610A1US 20050049610 A1US20050049610 A1US 20050049610A1US 93271604 AUS93271604 AUS 93271604AUS 2005049610 A1US2005049610 A1US 2005049610A1
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- Prior art keywords
- catheter
- outer sheath
- tubular member
- opening
- proximal
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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
- 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
- A61F2230/0093—Umbrella-shaped, e.g. mushroom-shaped
Definitions
- the present inventionrelates generally to devices and methods for treating occluded or stenoic blood vessels. More particularly, the present invention relates to devices and methods for delivering or retrieving an embolic protection device from the vasculature of a patient.
- Atherosclerosisis a major problem wherein blood vessels become blocked or narrowed. This blockage can result in lack of oxygenation to the heart. It is critical that the heart muscle be well oxygenated so that the blood pumping action of the heart is not impaired.
- Occluded or stenotic blood vesselsmay be treated with a number of medical procedures including, for example, angioplasty and atherectomy.
- Angioplasty techniquessuch as percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA) are relatively non-invasive methods of treating a stenotic lesion. These angioplasty techniques typically involve the use of a balloon catheter. The balloon catheter is advanced over a guidewire such that the balloon is positioned adjacent a stenotic lesion. The balloon is then inflated and the restriction in the vessel is opened. During an atherectomy procedure, the stenotic lesion may be mechanically cut away from the blood vessel wall using an atherectomy catheter.
- PTApercutaneous transluminal angioplasty
- PTCApercutaneous transluminal coronary angioplasty
- stenotic debristhat is separated from the stenosis may be free to flow within the lumen of the vessel. If this debris enters the circulatory system, it could block other vascular regions including the neural vasculature, or in the lungs. An occlusion in the neural vasculature may cause a stroke, and an occlusion in the lungs may interfere with the oxygenation of the blood.
- stenotic debrismay also break loose due to manipulation of the blood vessel. Because of this debris, a number of devices termed embolic protection devices have been developed to filter out this debris.
- the present inventionrelates generally to devices and methods for treating occluded or stenoic blood vessels. More particularly, the present invention relates to devices and methods for delivering or retrieving an embolic protection device from the vasculature of a patient.
- An embodiment of the inventionincludes a filter retrieval catheter.
- the filter retrieval cathetermay comprise an inner shaft slidably disposed within an outer sheath.
- the inner shaftmay include a proximal end, a mid-region, and a tapered distal end.
- the distal endmay include a tubular member.
- a guidewirecan be adapted to pass through the tubular member of the inner shaft.
- the guidewiremay include an embolic protection device coupled to a distal end thereof.
- the outer sheathmay further comprise an opening.
- a cover sheathmay be disposed about the outer sheath, for example over the opening.
- Preparation of the retrieval cathetermay comprise elimination of air from vacant space between the inner shaft and the outer sheath. Air may be substantially eliminated from the vacant space by flushing the vacant space with a fluid. Fluid can be additionally flushed through the proximal end of the catheter and through the opening. In addition to the vacant spaces, distant vacant spaces may need to be flushed.
- the tubular membermay further comprise a plurality of flush holes.
- FIG. 1is a cross sectional view of a filter retrieval catheter in an arrangement suitable for advancement through the vasculature;
- FIG. 2is a cross sectional view of a filter retrieval catheter in an arrangement suitable for removal from the vasculature;
- FIG. 3is a side view of an alternate embodiment of an outer sheath further comprising a cover sheath;
- FIG. 4is a top view of the cover sheath according an embodiment
- FIG. 5is a cross sectional view for preparation of a filter retrieval catheter according to an embodiment of the invention.
- FIG. 6is an alternate cross sectional view for preparation of a filter retrieval catheter according to an embodiment of the invention.
- FIG. 1is a cross sectional view of a filter retrieval and delivery catheter 10 in an arrangement suitable for advancement through the vasculature.
- a filter retrieval catheter 10may comprise an inner shaft 12 slidably disposed within an outer sheath 14 .
- Inner shaft 12may include a proximal end 16 , a mid-region 18 , and a distal end 20 .
- Proximal end 16may comprise an elongate tube.
- the elongate tubemay be comprised of materials including, but not limited to, thermoplastics, high performance engineering resins: fluorinated ethylene propylene (FEP), polyethylene (PE), polypropylene (PP), polyvinylchloride (PVC), polyurethane, polytetrafluoroethylene (PTFE), polyether-ether ketone (PEEK), polyimide, polyamide, polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polysufone, nylon, perfluoro(propyl vinyl ether) (PFA), metals: stainless steel, nickel alloys, nickel-titanium alloys, and combinations thereof.
- FEPfluorinated ethylene propylene
- PEpolyethylene
- PPpolypropylene
- PVCpolyviny
- Proximal end 16may be held to secure inner shaft 12 relative to outer sheath 14 , for example be a lock wire 22 .
- inner shaft 12may be held in place relative to a guidewire 24 .
- movement of guidewire 24results in substantially similar movement of inner shaft 12 .
- movement of either guidewire 24 or inner shaft 12may occur independently of movement of outer sheath 14 .
- Mid-region 18may comprise an opening on each of two opposite ends. The openings may be appropriate for coupling mid-region 18 to proximal end 16 and distal end 20 .
- Mid-region 18may comprise a polymer or metal, including those listed above.
- mid-region 18comprises polyethylene.
- Distal end 20may comprise a tubular member 26 having a proximal region 28 , a distal region 30 , and a lumen 32 extending therethrough.
- Lumen 32may be a guidewire lumen adapted for housing guidewire 24 .
- Distal end 20may comprise polyimide.
- distal end 20may comprise materials similar to those listed above.
- Tubular member 26is coupled to mid-region 18 .
- tubular member 26may be disposed within an opening within mid-region 18 and bend to exit a second opening within mid-region 18 .
- the bend in tubular member 26 when exiting mid-region 18may define a port 34 that may be disposed at proximal region 28 .
- a tip 36can be disposed at distal region 30 of tubular member 26 .
- Tip 36is comprised of generally soft or atraumatic materials.
- tip 36may be comprised of materials including polymers.
- tip 36may be comprised of materials similar to those listed above.
- Outer sheath 14may be disposed around inner shaft 12 .
- Outer sheath 14may be comprised of materials including, but not limited to, metals, alloys, nickel alloys, nickel titanium alloys, polymers, and combinations thereof. Alternatively, outer sheath 14 may be comprised of materials similar to those listed above.
- Outer sheath 14includes a proximal end 38 , a distal end 40 , and a lumen 42 extending therethrough. Lumen 42 is sized to allow inner shaft 12 to be slidably disposed therein.
- Outer sheath 14may include an opening 44 .
- Opening 44can be, for example, about 2 inches long. Opening 44 can be, for example, less than about 4 inches long. Opening 44 may further comprise a proximal region 46 and a distal region 48 .
- inner shaft 12is disposed within lumen 42 such that port 34 is disposed substantially proximate opening 44 .
- Guidewire 24may further include a proximal end 50 and a distal end 52 .
- An embolic protection device 54such as a distal protection filter, may be disposed at distal end 52 .
- Embolic protection device 54is adapted to prevent embolic debris from travelling away from a treatment site. According to this embodiment, embolic protection device 54 can substantially prevent embolic debris from occluding a blood vessel down stream from a treatment site.
- Catheter 10may be used as a filter retrieval catheter or a filter delivery catheter.
- catheter 10When used to retrieve embolic protection device 54 , catheter 10 is configured relative to guidewire 24 and inner shaft 12 is configured relative to outer sheath 14 .
- catheter 10As to configuring catheter 10 relative to guidewire 24 , catheter 10 is generally passed over guidewire 24 .
- guidewire 24passes through lumen 32 of tubular member 26 , through port 34 , and through opening 44 .
- Proximal end 50 of guidewire 24extends proximally out of outer sheath 14 at opening 44 .
- Distal end 52 of guidewire 24extends distally out of tip 36 of distal region 30 of inner shaft 12 .
- guidewire 24When configured for retrieving embolic protection device 54 (or when generally configured for advancing through the vasculature) guidewire 24 may be locked relative to inner shaft, for example by locking wire 22 . Moreover, guidewire 24 is generally disposed at a location near distal region 48 of opening 44 (as shown in FIG. 1 ). Disposing guidewire 24 near distal region 48 of opening 44 may be advantageous when using catheter 10 for retrieval. For example, positioning guidewire 24 near distal region 48 during retrieval (or generally during advancement of catheter 10 through the vasculature) makes available space for guidewire 24 to shift (proximally) within opening 44 . This feature is important because guidewire 24 and inner shaft 12 may be locked. Thus, allowing space for guidewire 24 to proximally shift may allow movement or shifting of inner shaft 12 relative to sheath 14 (as described in more detail below).
- inner shaft 12may be oriented in a first position (as shown in FIG. 1 ). In the first position, inner shaft 12 is positioned distally within sheath 14 such that at least a portion of tip 36 extends out from outer sheath 14 . In an exemplary embodiment, a tapered portion of tip 36 extends out of outer sheath 14 when inner shaft 12 is in the first position.
- the first positionis appropriate for advancing catheter 10 through the vasculature and provides a generally tapered or atraumatic distal end to catheter 10 .
- Retrieval of embolic protection device 54may then be accomplished by advancing catheter 10 through the vasculature to a position near embolic protection device 54 (for example, as shown in FIG. 1 ).
- inner shaft 12can be shifted from the first position to a second position. Shifting can occur by advancing sheath 14 distally relative to inner shaft 12 . Shifting inner shaft 12 to the second position results in sheath 14 moving distally over inner shaft 12 such that tip 36 is disposed a distance proximally of distal end 40 of sheath 14 (as shown in FIG. 2 ).
- guidewire 24may be locked relative to inner shaft 12 , shifting the position of inner shaft 12 results in shifting of guidewire 24 relative to sheath 15 .
- guidewire 24shifts such that it becomes disposed near proximal end 46 of opening.
- embolic protection device 54is coupled to guidewire 24 , shifting inner shaft 12 to the second position results in sheath 14 passing distally over at least a portion of embolic protection device 54 (as shown in FIG. 2 ).
- catheter 10and, thus, embolic protection device 54
- Catheter 10may also be used to deliver embolic protection device 54 .
- inner shaft 12may be in the second position (as shown in FIG. 2 ) and advanced through the vasculature. While advancing, embolic protection device 54 may be at least partially collapsed within sheath 14 .
- sheath 14may be shifted (in the proximal direction) relative to inner shaft 12 and guidewire 24 such that embolic protection device 54 emerges from distal end 40 of sheath 14 .
- embolic protection device 54is designed to be self-expanding such that when device 54 emerges from sheath 14 it assumes the expanded configuration appropriate for filtering embolic debris.
- the shift of sheath 14 in the proximal directionallows embolic protection device 54 to expand and be delivered.
- catheter 10may be removed from the vasculature.
- FIG. 2is a cross sectional view of a filter retrieval catheter in an arrangement suitable for removal from the vasculature.
- Inner shaft 12can be shifted from the first position to a second position relative to outer sheath 14 as shown.
- tip 36may be substantially contained within lumen 42 of outer sheath 14 .
- embolic protection device 54may be disposed within outer sheath 14 after shifting from the first position to the second position. Shifting results in inner shaft 12 (specifically proximal region 28 and/or port 34 ) becoming disposed near proximal region 46 of opening 44 .
- guidewire 24may be secured in place during relative to sheath 14 and both can be removed proximally from the patient's vasculature.
- FIG. 3is a side view of an alternate embodiment of an outer sheath further comprising a cover sheath.
- a cover sheath 56may be disposed on outer sheath 14 over opening 44 .
- Cover sheath 56may be comprised of a number of materials including polymers. Alternatively, cover sheath 56 may be comprised of materials similar to those listed above.
- Cover sheath 56may be coupled to outer sheath 14 in a number of differing manners.
- cover sheath 56may be coupled to outer sheath 14 by an adhesive.
- Alternative methods for coupling cover sheath 56would be familiar to those of ordinary skill in the art.
- FIG. 4is a top view of the cover sheath according an embodiment.
- Cover sheath 56can further comprise a slot 58 .
- Slot 58may be sized appropriately for passage of guidewire 24 .
- slot 58may be substantially self-resealing. Self-resealing is understood to mean that slot 58 essentially prevents the passage of fluids therethrough but allows guidewire 24 to be moveable therein.
- FIG. 5is a cross sectional view for preparation of a filter retrieval catheter according to an embodiment of the invention.
- Preparation of filter retrieval catheter 10may include the step of substantially eliminating of air from vacant space 60 within inner shaft 12 . Air may be substantially eliminated from vacant space 60 by flushing vacant space 60 with a fluid, such as saline. Alternative flushing mediums may be used without departing from the spirit of the invention.
- fluidmay be flushed through distal region 30 of tubular member 26 and throughout tubular member 26 . Fluid can be additionally flushed through proximal end 38 of outer sheath 14 , distal end 40 of outer sheath 14 , and through opening 44 . Flushing substantially eliminates air from vacant space 60 .
- FIG. 6is a cross sectional view for preparation of a filter retrieval catheter according to an embodiment of the invention.
- distant vacant spaces 62may be present. According to some embodiments of the invention, distant vacant spaces 62 may not be adequately flushed by the using the preparation strategy shown in FIG. 5 .
- an alternate filter retrieval catheter 110may be constructed including an alternate inner shaft 112 .
- Inner shaft 112may comprise tubular member 126 .
- Tubular member 126can further comprise a plurality of flush holes 164 . According to this embodiment, flushing fluid through inner shaft 112 and through tubular member 126 may result in substantial flushing of distant vacant spaces 62 by allowing fluid to be flushed through holes 164 .
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Abstract
Description
- The present invention relates generally to devices and methods for treating occluded or stenoic blood vessels. More particularly, the present invention relates to devices and methods for delivering or retrieving an embolic protection device from the vasculature of a patient.
- Atherosclerosis is a major problem wherein blood vessels become blocked or narrowed. This blockage can result in lack of oxygenation to the heart. It is critical that the heart muscle be well oxygenated so that the blood pumping action of the heart is not impaired.
- Occluded or stenotic blood vessels may be treated with a number of medical procedures including, for example, angioplasty and atherectomy. Angioplasty techniques such as percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA) are relatively non-invasive methods of treating a stenotic lesion. These angioplasty techniques typically involve the use of a balloon catheter. The balloon catheter is advanced over a guidewire such that the balloon is positioned adjacent a stenotic lesion. The balloon is then inflated and the restriction in the vessel is opened. During an atherectomy procedure, the stenotic lesion may be mechanically cut away from the blood vessel wall using an atherectomy catheter.
- During atherectomy procedures, stenotic debris that is separated from the stenosis may be free to flow within the lumen of the vessel. If this debris enters the circulatory system, it could block other vascular regions including the neural vasculature, or in the lungs. An occlusion in the neural vasculature may cause a stroke, and an occlusion in the lungs may interfere with the oxygenation of the blood. During angioplasty procedures, stenotic debris may also break loose due to manipulation of the blood vessel. Because of this debris, a number of devices termed embolic protection devices have been developed to filter out this debris.
- The present invention relates generally to devices and methods for treating occluded or stenoic blood vessels. More particularly, the present invention relates to devices and methods for delivering or retrieving an embolic protection device from the vasculature of a patient.
- An embodiment of the invention includes a filter retrieval catheter. The filter retrieval catheter may comprise an inner shaft slidably disposed within an outer sheath. The inner shaft may include a proximal end, a mid-region, and a tapered distal end. The distal end may include a tubular member. A guidewire can be adapted to pass through the tubular member of the inner shaft. The guidewire may include an embolic protection device coupled to a distal end thereof.
- The outer sheath may further comprise an opening. In addition, a cover sheath may be disposed about the outer sheath, for example over the opening. The cover sheath may further comprise a slot that may allow the guidewire to be disposed therein. Retrieval of the embolic protection device may including shifting the position of the inner shaft relative to the opening in the outer sheath.
- Preparation of the retrieval catheter may comprise elimination of air from vacant space between the inner shaft and the outer sheath. Air may be substantially eliminated from the vacant space by flushing the vacant space with a fluid. Fluid can be additionally flushed through the proximal end of the catheter and through the opening. In addition to the vacant spaces, distant vacant spaces may need to be flushed. According to this embodiment, the tubular member may further comprise a plurality of flush holes.
FIG. 1 is a cross sectional view of a filter retrieval catheter in an arrangement suitable for advancement through the vasculature;FIG. 2 is a cross sectional view of a filter retrieval catheter in an arrangement suitable for removal from the vasculature;FIG. 3 is a side view of an alternate embodiment of an outer sheath further comprising a cover sheath;FIG. 4 is a top view of the cover sheath according an embodiment;FIG. 5 is a cross sectional view for preparation of a filter retrieval catheter according to an embodiment of the invention; andFIG. 6 is an alternate cross sectional view for preparation of a filter retrieval catheter according to an embodiment of the invention.- The following description should be read with reference to the drawings wherein like reference numerals indicate like elements throughout the several views. The detailed description and drawings represent select embodiments and are not intended to be limiting.
FIG. 1 is a cross sectional view of a filter retrieval anddelivery catheter 10 in an arrangement suitable for advancement through the vasculature. In an embodiment, afilter retrieval catheter 10 may comprise aninner shaft 12 slidably disposed within anouter sheath 14.Inner shaft 12 may include aproximal end 16, amid-region 18, and adistal end 20.Proximal end 16 may comprise an elongate tube. The elongate tube may be comprised of materials including, but not limited to, thermoplastics, high performance engineering resins: fluorinated ethylene propylene (FEP), polyethylene (PE), polypropylene (PP), polyvinylchloride (PVC), polyurethane, polytetrafluoroethylene (PTFE), polyether-ether ketone (PEEK), polyimide, polyamide, polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polysufone, nylon, perfluoro(propyl vinyl ether) (PFA), metals: stainless steel, nickel alloys, nickel-titanium alloys, and combinations thereof.Proximal end 16 may be held to secureinner shaft 12 relative toouter sheath 14, for example be alock wire 22. Alternatively,inner shaft 12 may be held in place relative to aguidewire 24. According to this embodiment, movement ofguidewire 24 results in substantially similar movement ofinner shaft 12. Moreover, movement of eitherguidewire 24 orinner shaft 12 may occur independently of movement ofouter sheath 14.- Mid-region18 may comprise an opening on each of two opposite ends. The openings may be appropriate for coupling
mid-region 18 toproximal end 16 anddistal end 20. Mid-region18 may comprise a polymer or metal, including those listed above. In an exemplary embodiment, mid-region18 comprises polyethylene. Distal end 20 may comprise atubular member 26 having aproximal region 28, adistal region 30, and alumen 32 extending therethrough.Lumen 32 may be a guidewire lumen adapted forhousing guidewire 24.Distal end 20 may comprise polyimide. Alternatively,distal end 20 may comprise materials similar to those listed above.Tubular member 26 is coupled to mid-region18. For example,tubular member 26 may be disposed within an opening within mid-region18 and bend to exit a second opening within mid-region18. The bend intubular member 26 when exitingmid-region 18 may define aport 34 that may be disposed atproximal region 28. Atip 36 can be disposed atdistal region 30 oftubular member 26.Tip 36 is comprised of generally soft or atraumatic materials. For example,tip 36 may be comprised of materials including polymers. In addition,tip 36 may be comprised of materials similar to those listed above.Outer sheath 14 may be disposed aroundinner shaft 12.Outer sheath 14 may be comprised of materials including, but not limited to, metals, alloys, nickel alloys, nickel titanium alloys, polymers, and combinations thereof. Alternatively,outer sheath 14 may be comprised of materials similar to those listed above.Outer sheath 14 includes aproximal end 38, adistal end 40, and alumen 42 extending therethrough.Lumen 42 is sized to allowinner shaft 12 to be slidably disposed therein.Outer sheath 14 may include anopening 44.Opening 44 can be, for example, about 2 inches long.Opening 44 can be, for example, less than about 4 inches long.Opening 44 may further comprise aproximal region 46 and adistal region 48. In an exemplary embodiment,inner shaft 12 is disposed withinlumen 42 such thatport 34 is disposed substantiallyproximate opening 44.Guidewire 24 may further include aproximal end 50 and adistal end 52. Anembolic protection device 54, such as a distal protection filter, may be disposed atdistal end 52.Embolic protection device 54 is adapted to prevent embolic debris from travelling away from a treatment site. According to this embodiment,embolic protection device 54 can substantially prevent embolic debris from occluding a blood vessel down stream from a treatment site.Catheter 10 may be used as a filter retrieval catheter or a filter delivery catheter. When used to retrieveembolic protection device 54,catheter 10 is configured relative to guidewire24 andinner shaft 12 is configured relative toouter sheath 14. As to configuringcatheter 10 relative to guidewire24,catheter 10 is generally passed overguidewire 24. According to this embodiment, guidewire24 passes throughlumen 32 oftubular member 26, throughport 34, and throughopening 44.Proximal end 50 ofguidewire 24 extends proximally out ofouter sheath 14 atopening 44.Distal end 52 ofguidewire 24 extends distally out oftip 36 ofdistal region 30 ofinner shaft 12.- When configured for retrieving embolic protection device54 (or when generally configured for advancing through the vasculature) guidewire24 may be locked relative to inner shaft, for example by locking
wire 22. Moreover, guidewire24 is generally disposed at a location neardistal region 48 of opening44 (as shown inFIG. 1 ). Disposingguidewire 24 neardistal region 48 of opening44 may be advantageous when usingcatheter 10 for retrieval. For example, positioning guidewire24 neardistal region 48 during retrieval (or generally during advancement ofcatheter 10 through the vasculature) makes available space forguidewire 24 to shift (proximally) withinopening 44. This feature is important becauseguidewire 24 andinner shaft 12 may be locked. Thus, allowing space forguidewire 24 to proximally shift may allow movement or shifting ofinner shaft 12 relative to sheath14 (as described in more detail below). - As to configuring
inner shaft 12 relative toouter sheath 14,inner shaft 12 may be oriented in a first position (as shown inFIG. 1 ). In the first position,inner shaft 12 is positioned distally withinsheath 14 such that at least a portion oftip 36 extends out fromouter sheath 14. In an exemplary embodiment, a tapered portion oftip 36 extends out ofouter sheath 14 wheninner shaft 12 is in the first position. Generally, the first position is appropriate for advancingcatheter 10 through the vasculature and provides a generally tapered or atraumatic distal end tocatheter 10. - Retrieval of
embolic protection device 54 may then be accomplished by advancingcatheter 10 through the vasculature to a position near embolic protection device54 (for example, as shown inFIG. 1 ). Once located nearembolic protection device 54,inner shaft 12 can be shifted from the first position to a second position. Shifting can occur by advancingsheath 14 distally relative toinner shaft 12. Shiftinginner shaft 12 to the second position results insheath 14 moving distally overinner shaft 12 such thattip 36 is disposed a distance proximally ofdistal end 40 of sheath14 (as shown inFIG. 2 ). - Because
guidewire 24 may be locked relative toinner shaft 12, shifting the position ofinner shaft 12 results in shifting ofguidewire 24 relative to sheath15. In general, wheninner shaft 12 shifts to the second position, guidewire24 shifts such that it becomes disposed nearproximal end 46 of opening. Becauseembolic protection device 54 is coupled toguidewire 24, shiftinginner shaft 12 to the second position results insheath 14 passing distally over at least a portion of embolic protection device54 (as shown inFIG. 2 ). When at least a portion ofembolic protection device 54 is disposed withinsheath 14, catheter10 (and, thus, embolic protection device54) may be removed from the vasculature. Catheter 10 may also be used to deliverembolic protection device 54. For example,inner shaft 12 may be in the second position (as shown inFIG. 2 ) and advanced through the vasculature. While advancing,embolic protection device 54 may be at least partially collapsed withinsheath 14. Upon reaching a desired location,sheath 14 may be shifted (in the proximal direction) relative toinner shaft 12 and guidewire24 such thatembolic protection device 54 emerges fromdistal end 40 ofsheath 14. Generally,embolic protection device 54 is designed to be self-expanding such that whendevice 54 emerges fromsheath 14 it assumes the expanded configuration appropriate for filtering embolic debris. Thus, the shift ofsheath 14 in the proximal direction allowsembolic protection device 54 to expand and be delivered. Onceembolic protection device 54 is delivered,catheter 10 may be removed from the vasculature.FIG. 2 is a cross sectional view of a filter retrieval catheter in an arrangement suitable for removal from the vasculature.Inner shaft 12 can be shifted from the first position to a second position relative toouter sheath 14 as shown. In thesecond position tip 36 may be substantially contained withinlumen 42 ofouter sheath 14. In addition, a portion ofembolic protection device 54 may be disposed withinouter sheath 14 after shifting from the first position to the second position. Shifting results in inner shaft12 (specificallyproximal region 28 and/or port34) becoming disposed nearproximal region 46 ofopening 44. Subsequent to shifting, guidewire24 may be secured in place during relative tosheath 14 and both can be removed proximally from the patient's vasculature.FIG. 3 is a side view of an alternate embodiment of an outer sheath further comprising a cover sheath. Acover sheath 56 may be disposed onouter sheath 14 overopening 44.Cover sheath 56 may be comprised of a number of materials including polymers. Alternatively, coversheath 56 may be comprised of materials similar to those listed above.Cover sheath 56 may be coupled toouter sheath 14 in a number of differing manners. For example, coversheath 56 may be coupled toouter sheath 14 by an adhesive. Alternative methods forcoupling cover sheath 56 would be familiar to those of ordinary skill in the art.FIG. 4 is a top view of the cover sheath according an embodiment.Cover sheath 56 can further comprise aslot 58.Slot 58 may be sized appropriately for passage ofguidewire 24. In addition,slot 58 may be substantially self-resealing. Self-resealing is understood to mean thatslot 58 essentially prevents the passage of fluids therethrough but allowsguidewire 24 to be moveable therein.FIG. 5 is a cross sectional view for preparation of a filter retrieval catheter according to an embodiment of the invention. Preparation offilter retrieval catheter 10 may include the step of substantially eliminating of air fromvacant space 60 withininner shaft 12. Air may be substantially eliminated fromvacant space 60 by flushingvacant space 60 with a fluid, such as saline. Alternative flushing mediums may be used without departing from the spirit of the invention.- To prepare
filter retrieval catheter 10, fluid may be flushed throughdistal region 30 oftubular member 26 and throughouttubular member 26. Fluid can be additionally flushed throughproximal end 38 ofouter sheath 14,distal end 40 ofouter sheath 14, and throughopening 44. Flushing substantially eliminates air fromvacant space 60. FIG. 6 is a cross sectional view for preparation of a filter retrieval catheter according to an embodiment of the invention. In addition tovacant spaces 60, distantvacant spaces 62 may be present. According to some embodiments of the invention, distantvacant spaces 62 may not be adequately flushed by the using the preparation strategy shown inFIG. 5 .- To address this issue, an alternate
filter retrieval catheter 110 may be constructed including an alternateinner shaft 112.Inner shaft 112 may comprisetubular member 126.Tubular member 126 can further comprise a plurality of flush holes164. According to this embodiment, flushing fluid throughinner shaft 112 and throughtubular member 126 may result in substantial flushing of distantvacant spaces 62 by allowing fluid to be flushed throughholes 164. - It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the invention. The invention's scope is, of course, defined in the language in which the appended claims are expressed.
Claims (30)
1-27. (Cancelled)
28. A catheter, comprising:
an outer sheath having a proximal end, a distal end, a side opening, and a lumen extending therethrough;
an inner member slidably disposed within the lumen of the outer sheath, said inner member including a tubular member having a proximal opening in communication with the side opening, a distal opening, a distal tip, and a lumen extending therethrough adapted to sidably receive a guidewire; and
wherein the inner member is actuatable between a first position and a second position relative to the outer sheath, said distal tip extending at least in part distally of the distal end of the outer sheath in the first position and a distance proximally of the distal end of the outer sheath in the second position.
29. The catheter ofclaim 28 , wherein the side opening includes a proximal region and a distal region.
30. The catheter ofclaim 29 , wherein the proximal opening of the tubular member is disposed adjacent to the distal region of the side opening during said first position.
31. The catheter ofclaim 29 , wherein the proximal opening of the tubular member is disposed adjacent to the proximal region of the side opening during said second position.
32. The catheter ofclaim 28 , wherein the proximal opening of the tubular member remains in communication with the side opening of the outer sheath during said first and second positions.
33. The catheter ofclaim 28 , wherein the length of the side opening is between about one to four inches in length.
34. The catheter ofclaim 28 , wherein the inner member further includes a lock wire.
35. The catheter ofclaim 34 , wherein a mid-region of the inner member couples the lock wire to the tubular member.
36. The catheter ofclaim 28 , wherein the tubular member includes a plurality of side openings.
37. The catheter ofclaim 36 , wherein the side openings of the tubular member are flush holes.
38. The catheter ofclaim 28 , wherein the distal tip is tapered.
39. The catheter ofclaim 28 , further comprising an embolic protection filter coupled to the guidewire.
40. The catheter ofclaim 28 , further comprising a cover sheath disposed about the side opening of the outer sheath.
41. The catheter ofclaim 40 , wherein the cover sheath includes a slot.
42. The catheter ofclaim 41 , wherein the slot is substantially self-resealing.
43. A catheter, comprising:
an outer sheath having a proximal end, a distal end, a side opening, and a lumen extending therethrough;
an inner member slidably disposed within the lumen of the outer sheath, said inner member having a proximal region including a lock wire, a distal region including a tubular member, and a mid-region coupling the lock wire to the tubular member;
the tubular member having a proximal opening in communication with the side opening, a distal opening, a distal tip, and a lumen extending theretrough adapted to slidably receive a guidewire; and
wherein the inner member is actuatable between a first position and a second position relative to the outer sheath, said distal tip extending at least in part distally of the distal end of the outer sheath in the first position and a distance proximally of the distal end of the outer sheath in the second position.
44. The catheter ofclaim 43 , wherein the side opening includes a proximal region and a distal region.
45. The catheter ofclaim 44 , wherein the proximal opening of the tubular member is disposed adjacent to the distal region of the side opening during said first position.
46. The catheter ofclaim 44 , wherein the proximal opening of the tubular member is disposed adjacent to the proximal region of the side opening during said second position.
47. The catheter ofclaim 43 , wherein the proximal opening of the tubular member remains in communication with the side opening of the outer sheath during said first and second positions.
48. The catheter ofclaim 43 , wherein the length of the side opening is between about one to four inches in length.
49. The catheter ofclaim 43 , wherein the tubular member includes a plurality of side openings.
50. The catheter ofclaim 49 , wherein the side openings of the tubular member are flush holes.
51. The catheter ofclaim 43 , wherein the distal tip is tapered.
52. The catheter ofclaim 43 , further comprising an embolic protection filter coupled to the guidewire.
53. The catheter ofclaim 43 , Amber comprising a cover sheath disposed about the side opening of the outer sheath.
54. The catheter ofclaim 53 , wherein the cover sheath includes a slot.
55. The catheter ofclaim 54 , wherein the slot is substantially self-resealing,
56. A catheter, comprising:
an outer sheath having a proximal end, a distal end, a side opening, and a lumen extending therethrough;
an inner member slidably disposed within the lumen of the outer sheath, said inner member including a tubular member having a proximal opening in communication with the side opening, a distal opening, a distal tip, and a lumen therethrough adapted to slidably receive a guidewire;
wherein the inner member is actuatable between a first position and a second position relative to the outer sheath, said distal tip extending at least in part distally of the distal end of the outer sheath in the first position and a distance proximally of the distal end of the outer sheath in the second position; and
wherein the proximal opening of the tubular member remains in communication with the side opening of the outer sheath during said first and second positions.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10/932,716US20050049610A1 (en) | 2002-02-12 | 2004-09-02 | Embolic protection device |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10/075,485US6997938B2 (en) | 2002-02-12 | 2002-02-12 | Embolic protection device |
| US10/932,716US20050049610A1 (en) | 2002-02-12 | 2004-09-02 | Embolic protection device |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| US10/075,485ContinuationUS6997938B2 (en) | 2002-02-12 | 2002-02-12 | Embolic protection device |
Publications (1)
| Publication Number | Publication Date |
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| US20050049610A1true US20050049610A1 (en) | 2005-03-03 |
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ID=27660094
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| Application Number | Title | Priority Date | Filing Date |
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| US10/075,485Expired - LifetimeUS6997938B2 (en) | 2002-02-12 | 2002-02-12 | Embolic protection device |
| US10/932,716AbandonedUS20050049610A1 (en) | 2002-02-12 | 2004-09-02 | Embolic protection device |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| US10/075,485Expired - LifetimeUS6997938B2 (en) | 2002-02-12 | 2002-02-12 | Embolic protection device |
Country Status (8)
| Country | Link |
|---|---|
| US (2) | US6997938B2 (en) |
| EP (1) | EP1474072B1 (en) |
| JP (1) | JP4362372B2 (en) |
| AT (1) | ATE427076T1 (en) |
| AU (1) | AU2003217240B2 (en) |
| CA (1) | CA2475741A1 (en) |
| DE (1) | DE60326934D1 (en) |
| WO (1) | WO2003068106A1 (en) |
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Cited By (4)
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| US20070016247A1 (en)* | 2001-12-13 | 2007-01-18 | Scimed Life Systems, Inc. | Hydraulic controlled retractable tip filter retrieval catheter |
| US20060030876A1 (en)* | 2002-10-29 | 2006-02-09 | Peacock James C Iii | Embolic filter device and related systems and methods |
| US20070250106A1 (en)* | 2006-04-24 | 2007-10-25 | Boston Scientific Scimed, Inc. | Self-flushing medical apparatus |
| US7867246B2 (en) | 2006-04-24 | 2011-01-11 | Boston Scientific Scimed, Inc. | Self-flushing medical apparatus |
Also Published As
| Publication number | Publication date |
|---|---|
| CA2475741A1 (en) | 2003-08-21 |
| US6997938B2 (en) | 2006-02-14 |
| JP4362372B2 (en) | 2009-11-11 |
| WO2003068106A1 (en) | 2003-08-21 |
| US20030153942A1 (en) | 2003-08-14 |
| DE60326934D1 (en) | 2009-05-14 |
| EP1474072B1 (en) | 2009-04-01 |
| AU2003217240A1 (en) | 2003-09-04 |
| AU2003217240B2 (en) | 2007-09-13 |
| JP2005516730A (en) | 2005-06-09 |
| EP1474072A1 (en) | 2004-11-10 |
| ATE427076T1 (en) | 2009-04-15 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| AS | Assignment | Owner name:BOSTON SCIENTIFIC SCIMED, INC., MINNESOTA Free format text:CHANGE OF NAME;ASSIGNOR:SCIMED LIFE SYSTEMS, INC.;REEL/FRAME:018505/0868 Effective date:20050101 Owner name:BOSTON SCIENTIFIC SCIMED, INC.,MINNESOTA Free format text:CHANGE OF NAME;ASSIGNOR:SCIMED LIFE SYSTEMS, INC.;REEL/FRAME:018505/0868 Effective date:20050101 | |
| STCB | Information on status: application discontinuation | Free format text:ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |