WO2000056390A1 - Free standing filter - Google Patents
Free standing filter Download PDFInfo
- Publication number
- WO2000056390A1 WO2000056390A1 PCT/US2000/003725 US0003725W WO0056390A1 WO 2000056390 A1 WO2000056390 A1 WO 2000056390A1 US 0003725 W US0003725 W US 0003725W WO 0056390 A1 WO0056390 A1 WO 0056390A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- frame
- receiving member
- elongate
- filter
- capturing unit
- Prior art date
Links
Classifications
-
- 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
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/005—Rosette-shaped, e.g. star-shaped
-
- 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
Definitions
- the present invention relates generally to small filters for insertion into a vein or artery, and more particularly to a filter which, when expanded, is free standing in engagement with a body vessel without penetrating the vessel wall.
- the device in a flexible and reduced stress state may be compressed to fit within the bore of a delivery catheter when exposed to a temperature below a predetermined transition temperature, but at temperatures at or above the transition temperature, the device expands and becomes relatively rigid.
- Known self expanding medical devices have been formed of Nitinol, an alloy of titanium and nickel which provides the device with a thermal memory.
- the unique characteristic of this alloy is its thermally triggered shape memory, which allows a device constructed of the alloy to be cooled below a temperature transformation level to a martensitic state and thereby softened for loading into a catheter in a relatively compressed and elongated state, and to regain the memorized shape in an austenitic state when warmed to a selected temperature, above the temperature transformation level, such as human body temperature.
- the two interchangeable shapes are possible because of the two distinct microcrystalline structures that are interchangeable with a small variation in temperature.
- the temperature at which the device assumes its first configuration may be varied within wide limits by changing the composition of the alloy.
- the alloy may be focused on a transition temperature range close to 98.6°F, the alloy readily may be modified for use in animals with different body temperatures.
- advances have been made in the treatment of blood vessel stenosis or occlusion by plaque, thrombi, embolic, or other deposits which adversely reduce or block the flow of blood through a vessel.
- Balloon angioplasty or similar transluminal treatments have become common for some blood vessel lesions, but for all such procedures, plaque and emboli dislodged during the procedure are free to flow within the lumen of the vessel and possibly cause substantial injury to a patient.
- Angioplasty is often not a preferred treatment for lesions in the carotid artery because dislodged plaque can enter arterial vessels of the brain causing brain damage or even death.
- carotid endarterectomy is a surgical procedure used to remove a lesion in the carotid artery, but this procedure also involves substantial risk of dislodged embolic material.
- an angioplasty balloon, a stent, or other devices are introduced over the proximal end of the guidewire or catheter to which the filter is attached and moved into position in the area of the occlusion or stenosis spaced proximally from the filter.
- distal filters While retaining captured embolic material has proven to be problematic.
- Many cone shaped filters with wide, upstream proximal open ends tend to eject captured embolic material through the open end as the filter is collapsed.
- many distal filters are formed by a mesh material which is expanded by a filter frame, and when the frame closes to collapse the filter for withdrawal through a catheter, the mesh folds creating outwardly projecting pleats. These pleats snag on the withdrawal catheter making retrieval of the filter difficult and often causing the filter to spill captured embolic material.
- Another object of the present invention is to provide a novel and improved free standing filter for use during a procedure to treat blood vessel stenosis or occlusion which does not cause trauma to the luminal wall during guidewire balloon and stent exchanges.
- a further object of the present invention is to provide a novel and improved free standing filter for use during a procedure to treat blood vessel stenosis or occlusion which includes an elastomeric or knitted fiber mesh which collapses without pleating during the filter recovery process.
- a still further obj ect of the present invention is to provide a novel and improved free standing filter for use during a procedure to treat blood vessel stenosis or occlusion which is formed to capture and safely remove embolic material.
- the filter is provided with a proximal end designed for docking with a recovery system and which operates to positively close the open end of a filter mesh as the filter is collapsed during recovery.
- An expandable and contractible frame surrounds the elongate guidewire receiving member and is connected at a proximal end to the elongate guidewire receiving member.
- a porous embolic capturing unit has an open end connected to the frame and a closed end connected to the elongate guidewire receiving member which extends through the porous embolic capturing unit.
- Figure 1 is a view in side elevation of the free standing filter of the present invention in the expanded configuration
- Figure 2 is a partially sectional view in side elevation of a second embodiment of the free standing filter of the present invention.
- Figure 3 is a partially sectional view of the free standing filter of Figure 2 within a delivery tube
- Figure 4 is a sectional view of a positioning and recovery unit for the free standing filter of Figure 2;
- Figure 5 is a sectional view of the positioning and recovery unit of Figure 4 engaged with the free standing filter.
- the free standing filter 10 of the present invention is formed around a central tube 11 which forms the longitudinal axis for the filter 10 and slidingly receives a guidewire 12.
- the frame of the filter is formed by a stent 14 which may be collapsed inwardly toward the tube 11 and which expands outwardly away from the tube to the substantially cylindrical open ended configuration shown in the drawings.
- this stent is formed of thermal shape memory material and is of the type shown by U.S. PatentNo. 5,540,712, although other expandable stents can be used.
- the stent 14 is coupled at one end to the central tube 11 by elongate lead wires 16 which extend between an open proximal end 18 of the stent and a spaced coupling 20 which is secured to the central tube 11.
- a flexible, fine mesh filter material 22 which opens at the proximal end 18 of the stent and covers the body of the stent. Ideally, the stent extends over this mesh filter material.
- the fine mesh filter material projects outwardly to form a flexible conical section 26 with an apex 28 connected to a coupling 30 which slides on the tube 11 in spaced relation to the stent distal end 24.
- the mesh filter material forms a substantially cylindrical section 32 which opens at the proximal end of the stent and a flexible, closed conical section 26 which extends beyond the distal end of the stent to catch and collect small particles.
- the fine filter mesh may be formed of suitable biocompatible material such as polyester or a PTFE material and is coated with thromboresistant materials such as, for example, Phosphoral Choline or Hyaluronic Acid.
- the mesh is a braided material or elastomeric mesh which normally conforms to the exterior shape of the central tube 11, but which stretches to expand outwardly away from the tube when the stent 24 expands.
- the mesh is biased toward the tube 11 , and when the stent collapses inwardly toward the tube, the mesh contracts back to the exterior shape of the tube and does not form pleats.
- the stent with the mesh filter material is inserted in a collapsed condition into a delivery tube 34 and guidewire 12 extends through the central tube 11. Then the delivery tube is used to deliver the filter 10 over the guidewire
- the guidewire 12 may now be used to guide other devices into the vessel, and since the guidewire can move freely in a longitudinal direction within the tube 11 , longitudinal movement of the guidewire will not result in movement of the expanded filter.
- the guidewire 12 can be removed and replaced with a new guidewire of a different size.
- the tube 11 is preferably formed of sufficient size to accept .014 inch diameter to .035 inch diameter guidewires. It may often be desirable to initially use a very fine guidewire (.014") to cross a lesion and position the filter 10 and to then exchange this fine guidewire for a thicker wire.
- the fine mesh filter material 22 when expanded, should have a pore size within a range of 50 ⁇ m to 300 ⁇ m to capture and retain embolic material sized in excess of the pore size while permitting blood flow in the direction of the arrow 38 line in Figure 1 between the wires 16 and into the proximal end 18 of the stent 14.
- the blood and embolic material flows through the and into the flexible conical section 26 of the fine mesh filter material where the embolic material is trapped while the blood passes through the filter material.
- the stent 14 is collapsed against the tube 11 for withdrawal through a catheter or delivery tube 34.
- the stent is formed of the thermal shape memory material such as nitinol or other materials, for example, including but not limited to Titanium, stainless steel, MP35N alloys or other similar materials and may be collapsed by cooling the stent to a temperature below a transition temperature.
- the embolic material has been captured within the conical section 28, so that when the stent collapses against the tube 11, it positively closes the mouth of the conical section preventing material from escaping as the filter is drawn into the tube 34.
- the stent forces the entire longitudinal extent of the section 32 against the tube 11 to prevent the escape of material from the conical section 28.
- a second embodiment of the free standing filter of the present invention is indicated generally at 40.
- the filter 40 includes a cellular frame 42 which is preferably formed of thermal shape memory material such as nitinol, and this frame when expanded includes a central section 44 having a substantially tubular configuration, a proximal end section 46 and a distal end section
- a central tube 50 similar in size to the tube 11 , forms the central longitudinal axis for the filter 40 and extends through the filter and outwardly from the proximal and distal sections of the frame 42.
- the distal end of the tube 50 is provided with a tapered atraumatic molded tip 52 configured to center and guide the filter within the delivery tube 34.
- the central section 44 of the frame 42 includes a plurality of interconnected cells 54 which are substantially equal in size and which are defined by spaced sidewalls 56 and 58 which extend substantially parallel to the tube 50 and the longitudinal axis of the filter. Adjacent cells 54 in a row of cells extending around the central tube 50 are connected together by their adjacent sidewalls 56 and 58, and these sidewalls remain substantially parallel to the tube 50 in both the expanded and collapsed configuration of the filter 40 as illustrated in Figures 2 and 3.
- the opposite ends of each cell are formed by outwardly inclined endwall sections 60 and 62 which meet at an apex 64.
- proximal end section 46 and distal end section 48 of the frame 42 are formed of cells 68 with tapered sidewalls 70 and 72 which extend at an angle to the central tube 50 to form the tapered conical end sections of the frame.
- Proximal end section 46 of the frame is secured to the tube 50 by a coupling 74, and distal end section 48 is secured to a coupling 76 which slides on the tube 50.
- the couplings 74 and 76 are provided with radiopaque markers 78 and 80 respectively.
- Fine mesh filter material 82 of the type previously described for the filter 10 is positioned within the central and distal sections of the frame 42. This filter material is bonded to at least the first row of cells 54 in the proximal end of the central section 44 of the frame, and at the distal end of the frame the filter material is secured to the tube 50 adjacent to the coupling 76 by a coupling 84.
- the filter material forms a cone when the filter 40 is expanded, and the open proximal end of the cone is positively closed when the proximal end row of cells of the central section 44 collapse against the tube 50.
- FIG. 3 when the filter 40 moves along the guidewire 12 through the delivery tube 34, the mesh filter material 82 is enclosed within the frame 42 which protects the filter material. Also, when an expanded filter is contracted and drawn back into the delivery tube, the frame engages the delivery tube and precludes the filter from catching or snagging on the delivery tube.
- Figures 4 and 5 disclose a positioning and recovery system 84 for the filter 40. This system includes an elongate, flexible, tubular member 86 having a docking end 88 for receiving the coupling 74 of the filter 40.
- the docking end is provided with a plurality of longitudinally extending lumens 90, two of which are shown in Figures 4 and 5, and an outwardly inclined hook 92 of flexible material, such as stainless steel, is mounted in each lumen to extend outwardly from the docking end of the tubular member 86.
- the tubular member 86 with the hooks 92 engaged with the cells 68 extends over the guidewire 12 to move the filter through the delivery tube.
- the hooks spring open as illustrated in Figure 4 releasing the filter. If desirable, the filter can be moved further from the delivery tube by the engagement between the filter and the stepped docking end of the tubular member 86 before the delivery tube and the docking and positioning system are withdrawn.
- the tubular member 86 with the hooks 92 compressed as shown in Figure 5 is passed through the delivery tube and outwardly therefrom until the hooks spring open and are positioned over the cells 68 as shown in Figure 4. Now the delivery tube is moved over the hooks to compress and engage the hooks with the cells 68 as shown in Figure 5, and once the hooks are engaged, the filter can be drawn back into the delivery tube by the tubular member 86.
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP00915773A EP1165174A4 (en) | 1999-03-19 | 2000-03-16 | Free standing filter |
JP2000606291A JP2002539858A (en) | 1999-03-19 | 2000-03-16 | Free standing filter |
AU36993/00A AU3699300A (en) | 1999-03-19 | 2000-03-16 | Free standing filter |
CA002368158A CA2368158C (en) | 1999-03-19 | 2000-03-16 | Free standing filter |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12513499P | 1999-03-19 | 1999-03-19 | |
US09/401,606 | 1999-09-22 | ||
US09/401,606 US6245012B1 (en) | 1999-03-19 | 1999-09-22 | Free standing filter |
US60/125,134 | 1999-09-22 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2000056390A1 true WO2000056390A1 (en) | 2000-09-28 |
Family
ID=26823293
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2000/003725 WO2000056390A1 (en) | 1999-03-19 | 2000-03-16 | Free standing filter |
Country Status (6)
Country | Link |
---|---|
US (1) | US6245012B1 (en) |
EP (1) | EP1165174A4 (en) |
JP (1) | JP2002539858A (en) |
AU (1) | AU3699300A (en) |
CA (1) | CA2368158C (en) |
WO (1) | WO2000056390A1 (en) |
Cited By (25)
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EP1265669A1 (en) * | 1999-11-04 | 2002-12-18 | Concentric Medical, Inc. | Methods and devices for filtering fluid flow through a body structure |
JP2003010193A (en) * | 2001-07-02 | 2003-01-14 | Terumo Corp | Wire and medical instrument for removing foreign body in blood vessel |
WO2005027751A1 (en) * | 2003-09-22 | 2005-03-31 | Shin Ishimaru | Thrombus/embolus collecting device |
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WO2008010197A2 (en) * | 2006-07-19 | 2008-01-24 | Novate Medical Limited | A vascular filter |
WO2008111072A3 (en) * | 2007-03-15 | 2010-02-18 | Concept & Design Ltd. | A brewing element with a central inlet |
WO2010077963A1 (en) * | 2008-12-17 | 2010-07-08 | Abbott Laboratories Vascular Enterprises Limited | Implantable lumen filter with enhanced durability |
US8057507B2 (en) | 2009-01-16 | 2011-11-15 | Novate Medical Limited | Vascular filter |
US8062327B2 (en) | 2005-08-09 | 2011-11-22 | C. R. Bard, Inc. | Embolus blood clot filter and delivery system |
US8372109B2 (en) | 2004-08-04 | 2013-02-12 | C. R. Bard, Inc. | Non-entangling vena cava filter |
US8574261B2 (en) | 2005-05-12 | 2013-11-05 | C. R. Bard, Inc. | Removable embolus blood clot filter |
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WO2014199381A3 (en) * | 2013-06-12 | 2015-02-05 | Keystone Heart Ltd. | Intravascular device with multiple leaflets |
US8992562B2 (en) | 2004-11-12 | 2015-03-31 | C.R. Bard, Inc. | Filter delivery system |
US9131999B2 (en) | 2005-11-18 | 2015-09-15 | C.R. Bard Inc. | Vena cava filter with filament |
US9204956B2 (en) | 2002-02-20 | 2015-12-08 | C. R. Bard, Inc. | IVC filter with translating hooks |
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Also Published As
Publication number | Publication date |
---|---|
EP1165174A1 (en) | 2002-01-02 |
US6245012B1 (en) | 2001-06-12 |
EP1165174A4 (en) | 2006-08-30 |
AU3699300A (en) | 2000-10-09 |
CA2368158C (en) | 2007-07-03 |
CA2368158A1 (en) | 2000-09-28 |
JP2002539858A (en) | 2002-11-26 |
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