WO2000067665A1 - Support frame for embolic protection device - Google Patents

Support frame for embolic protection device Download PDF

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Publication number
WO2000067665A1
WO2000067665A1 PCT/IE1999/000035 IE9900035W WO0067665A1 WO 2000067665 A1 WO2000067665 A1 WO 2000067665A1 IE 9900035 W IE9900035 W IE 9900035W WO 0067665 A1 WO0067665 A1 WO 0067665A1
Authority
WO
WIPO (PCT)
Prior art keywords
filter
filter body
support
protection device
embolic protection
Prior art date
Application number
PCT/IE1999/000035
Other languages
French (fr)
Inventor
Paul Gilson
Michael Gilvarry
Original Assignee
Salviac Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Salviac Limited filed Critical Salviac Limited
Priority to PCT/IE1999/000035 priority Critical patent/WO2000067665A1/en
Priority to AU38443/99A priority patent/AU3844399A/en
Priority to JP2000616702A priority patent/JP2002543876A/en
Priority to DE60018729T priority patent/DE60018729T2/en
Priority to AT00925545T priority patent/ATE290830T1/en
Priority to DE20080306U priority patent/DE20080306U1/en
Priority to IL14597800A priority patent/IL145978A0/en
Priority to IE20000342A priority patent/IE20000342A1/en
Priority to CA002370747A priority patent/CA2370747A1/en
Priority to AU44264/00A priority patent/AU766399B2/en
Priority to PCT/IE2000/000054 priority patent/WO2000067669A1/en
Priority to DE10084570T priority patent/DE10084570T1/en
Priority to GB0124862A priority patent/GB2364918A/en
Priority to EP00925545A priority patent/EP1176922B1/en
Publication of WO2000067665A1 publication Critical patent/WO2000067665A1/en
Priority to ZA200108441A priority patent/ZA200108441B/en
Priority to US09/986,132 priority patent/US20020058911A1/en
Priority to US10/326,920 priority patent/US7014647B2/en
Priority to US10/326,884 priority patent/US6964672B2/en
Priority to US10/326,891 priority patent/US6918921B2/en
Priority to US10/797,612 priority patent/US20050080446A1/en
Priority to US11/068,044 priority patent/US20050209634A1/en
Priority to US11/068,530 priority patent/US20050288705A1/en
Priority to US11/166,805 priority patent/US7799051B2/en
Priority to US11/166,803 priority patent/US8002790B2/en
Priority to US11/505,469 priority patent/US20070032817A1/en
Priority to US11/753,928 priority patent/US20070225752A1/en
Priority to US11/753,827 priority patent/US8057506B2/en
Priority to US11/753,875 priority patent/US20070233176A1/en
Priority to US11/762,148 priority patent/US7922741B2/en
Priority to US11/762,169 priority patent/US20070233178A1/en
Priority to US11/762,314 priority patent/US7867248B2/en

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
    • A61F2/0108—Both ends closed, i.e. legs gathered at both ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/013—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

Definitions

  • This invention relates to a filter element for a transcatheter embolic protection device.
  • the invention is particularly concerned with filter elements for transcatheter embohc protection devices of the type described in our previously filed PCT Patent Application No. PCT/IE98/00093 the contents of which are incorporated herein by reference.
  • One type of such embolic filter essentially comprises a filter body mounted on an associated collapsible support frame which can be collapsed against the guide wire by means of a catheter for deployment of the filter through a patient's vascular system. Upon retraction of the catheter the support frame and filter body expand outwardly from the guidewire across a blood vessel within which the filter is positioned to filter blood flowing through the blood vessel.
  • the support structure is generally of shaped memory material such as nitinol which provides the circumferential pressure on expansion to secure the filter bodies in a close fit within the vessel.
  • the present invention is directed towards overcoming this problem.
  • an embolic protection device comprising:
  • a collapsible filter element for delivery through a vascular system of a patient
  • the filter being movable between a collapsed stored position for movement through the vascular system, and an expanded position for occluding a blood vessel such that blood passing through the blood vessel is dehvered through the filter element;
  • the filter element comprising a collapsible filter body and a filter support frame
  • the collapsible filter body having an inlet end and an outlet end, the inlet end of the filter body having one or more inlet openings sized to allow blood and embolic material enter the filter body, the outlet end of the filter body having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embohc material within the filter body;
  • the filter support frame being movable between a collapsed position for movement through the vascular system and an extended outwardly projecting position to support the filter body in the expanded position;
  • the filter support frame comprises a plurality of support elements, some of the support elements providing support for a first portion of the filter body and others of the support elements providing support for a second portion of the filter body.
  • the first portion is a proximal portion of the filter body which is supported by proximal support elements.
  • the second portion is a distal portion of the filter body which is supported by distal support elements.
  • the proximal support elements preferably comprise a plurality of proximal support arms. Preferably there are three substantially equi-spaced proximal support arms.
  • the distal support elements comprise a plurality of distal support arms. Preferably there are three substantially equi-spaced distal support arms.
  • Fig. 1 is partially sectioned elevational view an embolic protection device
  • Fig. 2 is a schematic sectional elevational view of the embolic protection device of Fig. 1;
  • Fig. 3 is a detail sectional view of portion of the device of Fig. 1;
  • Fig. 4 is a longitudinal cross sectional view of the device of Fig. 1;
  • Fig. 5 is a cross sectional view of a distal end of the device of Fig. 1;
  • Fig. 6 is a view on the line A-A in Fig. 5;
  • Fig. 7 is a perspective view of a filter body of the device of Figs. 1 to 6;
  • Fig. 8 is a side elevational view of the filter body of Fig. 7;
  • Fig. 9 is a view on a proximal end of the filter body
  • Fig. 10 is a perspective view of a support frame of the device of Figs. 1 to 6;
  • Fig. 11 is a side elevational view of the support frame
  • Fig. 12 is a perspective view illustrating the manufacture of the support frame
  • Fig. 13 is a view of the support frame and filter element assembly
  • Fig. 14 is a longitudinal cross sectional view of a filter element according to the invention.
  • Fig. 15 is a longitudinal cross sectional view a support frame of the filter element of Fig. 14;
  • Fig. 16 is a cross sectional on the line III-III of Fig. 15;
  • Fig. 17 is a cross sectional view on the line IV-IV of Fig. 15;
  • Fig. 18 is a cross sectional view on the line V-V of Fig. 15; and Fig. 19 is a longitudinal cross section view of another support frame.
  • FIG. 1 to 13 there is illustrated an embolic protection device as described in our co-pending Application PCT/IE98/00093 indicated generally by the reference number 100.
  • the device 100 has a guidewire 101 with a proximal end 102 and a distal end 103.
  • a tubular sleeve 104 is slidably mounted on the guidewire 101.
  • a collapsible filter 105 is mounted on the sleeve 104, the filter 105 being movable between a collapsed stored position against the sleeve 104 and an expanded position as shown in the drawings extended outwardly of the sleeve 104 for deployment in a blood vessel.
  • the sleeve 104 is slidable on the guidewire 101 between a pair of spaced-apart end stops, namely an inner stop 106 and an outer stop which in this case is formed by a spring tip 107 at the distal end 103 of the guidewire 101.
  • the filter 105 comprises a filter body 110 mounted over a collapsible support frame 111.
  • the filter body 110 is mounted to the sleeve 104 at each end, the body 110 being rigidly attached to a proximal end 112 of the sleeve 104 and the body
  • the support frame 111 is also fixed at the proximal end 112 of the sleeve 104.
  • a distal end 116 of the support frame 111 is not attached to the sleeve 104 and is thus also free to move longitudinally along the sleeve 104 to facilitate collapsing the support frame 111 against the sleeve 104.
  • the support frame 111 is such that it is naturally expanded as shown in the drawings and can be collapsed inwardly against the sleeve 104 for loading in a catheter 118 or the like.
  • the filter body 105 has large proximal inlet openings 117 and small distal outlet openings 119.
  • the proximal inlet openings 117 allow blood and embolic material to enter the filter body, however, the distal outlet openings 119 allow through passage of blood but retain undesired embolic material within the filter body.
  • An olive guide 120 is mounted at a distal end of the sleeve 104 and has a cylindrical central portion 121 with tapered ends 122, 123.
  • the distal end 122 may be an arrowhead configuration for smooth transition between the catheter and olive surfaces.
  • the support frame 111 is shaped to provide a circumferential groove 125 in the filter body 110. If the filter is too large for a vessel, the body may crease and this groove 125 ensures any crease does not propagate along the filter.
  • Enlarged openings are provided at a proximal end of the filter body 110 to allow ingress of blood and embolic material into an interior of the body 110.
  • the filter 105 is mounted in a collapsed state within a distal end of the catheter 118 and delivered to a deployment site.
  • the catheter 118 is retracted allowing the support frame 111 to expand expanding the filter body 110 across the vessel in which the filter is mounted.
  • Blood and emboli can enter the enlarged openings at a proximal end of the filter body 110.
  • the blood will pass through the net wall, however, the openings or pores in the net are sized so as to retain the embolic material.
  • the catheter is delivered along the guidewire 101 and slid over the filter 105 engaging the proximal inlet end 112 first to close the openings and then gradually collapsing the filter body against the sleeve 104 as the catheter 118 advances over the filter 105. Once the filter 105 is fully loaded in the catheter 118, it can then be withdrawn.
  • a proximal end of the filter is fixed and a distal end of the filter is longitudinally movable along the sleeve to facilitate collapsing of the filter body. Further, the catheter engages the proximal end of the filter body first thus closing the filter body inlet and preventing escape of embolic material from the filter body as the filter body is being collapsed.
  • the outer filter body 110 is preferably of a resilient biocompatible elastomeric material.
  • the material may be a polyurethane based material.
  • polyurethane based material There are a series of commercially available polyurethane materials that may be suitable. These are typically based on polyether or polycarbonate or silicone macroglycols together with diisocyanate and a diol or diamine or alkanolamine or water chain extender. Examples of these are described in EP-A-461,375 and US 5,621, 065.
  • polyurethane elastomers manufactured from polycarbonate polyols as described in US 5,254,622 (Szycher) are also suitable.
  • the filter material may also be a biostable polycarbonate urethane article an example of which may be prepared by reaction of an isocyanate, a chain extender and a polycarbonate copolymer polyol of alkyl carbonates. This material is described in our co-pending PCT Application No. IE98/00091, filed November 9,
  • the filter material may be manufactured from a block and cut into a desired shape. However the filter is preferably formed by dipping a rod of desired geometry into a solution of the material which coats the rod. The rod is then dissolved. The final geometry of the filter may be determined in the dipping step or the final geometry may be achieved in a finishing operation. Typically the finishing operations involve processes such as mechanical machining operations, laser machining or chemical machining.
  • the filter body is of hollow construction and is formed as described above by dipping a rod in a solution of polymeric material to coat the rod. The rod is then dissolved, leaving a hollow body polymeric material.
  • the rod may be of an acrylic material which is dissolved by a suitable solvent such as acetone.
  • the polymeric body thus formed is machined to the shape illustrated in Figs. 1 to 13.
  • the final machined filter body comprises an inlet or proximal portion 210 with a proximal neck 212, and oudet or distal portion 213 with a distal neck 214, and an intermediate portion 215 between the proximal and distal portions.
  • the inlet holes 117 are provided in the proximal portion 210 which allow the blood and embolic material to flow into the filter body.
  • the proximal portion 210 is of generally conical shape to maximise the hole size.
  • the intermediate portion 215 is also hollow and in this case is of generally cylindrical construction. This is important in ensuring more than simple point contact with the surrounding blood vessel.
  • the cylindrical structure allows the filter body to come into soft contact with the blood vessel to avoid damaging the vessel wall.
  • the intermediate portion 215 is provided with a radial stiffening means, in this case in the form of a radial strengthening ring or rim 220.
  • the ring 220 provides localised stiffening of the filter body without stiffening the material in contact with the vessel. Such an arrangement provides appropriate structural strength so that line apposition of the filter body to the vessel wall is achieved. It is expected that other geometries of stiffening means will achieve a similar result.
  • the tubular intermediate portion 215 is also important in maintaining the stability of the filter body in situ to retain captured emboli and to ensure that flow around the filter is minimised.
  • the ratio of the axial length of the intermediate portion 215 of the filter body to the diameter of the intermediate portion 215 is preferably at least 0.5 and ideally greater than 1.0.
  • the collapsible support frame 111 has four foldable arms 290 which are collapsed for deployment and upon release extend outwardly to expand the filter body 110.
  • the support frame 111 can be manufactured from a range of metallic or polymeric components such as a shape memory alloy like nitinol or a shape memory polymer or a shaped stainless steel or metal with similar properties that will recover from the deformation sufficiently to cause the filter body 110 to open.
  • the support frame may be formed as illustrated in Fig. 12 by machining slots in a tube 291 of shape memory alloy such as nitinol.
  • a tube 291 of shape memory alloy such as nitinol.
  • the unslotted distal end of the tube forms a distal collar 293 and the unslotted proximal end of the tube forms a proximal collar 294.
  • the distal collar 293 is slidably moveable along the tubular sleeve 104 which in turn is slidably mounted on the guidewire 101 for deployment and retrieval.
  • the proximal collar 294 is fixed relative to the tubular sleeve 104.
  • the sub assembly of the support frame and filter body is pulled back into the catheter 118 to engage the distal stop 107.
  • the support arms 290 are hinged inwardly and the distal collar 293 moves forward along the tubular sleeve 104.
  • the filter body 110 stretches as the filter body collar 115 slides along the tubular sleeve 104 proximal to the olive 120.
  • the catheter 118 is retracted proximally along the guidewire 101 initially bringing the collapsed filter assembly with it until it engages the proximal stop 106.
  • the catheter sleeve then begins to pull off the filter freeing the support arms 290 to expand and the filter body apposes the vessel wall.
  • a retrieval catheter is introduced by sliding it over the guidewire 101 until it is positioned at the proximal end of the filter body and support frame. Pulling the guidewire 101 will initially engage the distal stop 107 with the filter element and begin to pull it into the retrieval catheter. The initial travel into the delivery catheter acts to close the proximal openings of the filter element, thus entrapping the embolic load. As the filter continues to be pulled back the filter body and the support frame are enveloped in the retrieval catheter. The collapsed filter may then be removed from the patient.
  • FIG. 14 to 18 there is illustrated a support frame indicated generally by the reference numeral 30 for a filter 31.
  • the filter support frame comprises a plurality of support elements some of which provide support for one portion of the filter body 31 and some of which provide support for another portion of the filter body 31.
  • the filter can be more easily loaded and retrieved.
  • FIG. 19 there is illustrated another support frame 40 similar to that of Figs. 14 to 18. In this case adequate support is provided while omitting the distal collar 293.
  • This frame 40 is more easily formed and the same principle may be applied to other frames as those described above.

Abstract

A support frame (30) for an embolic protection filter (31). Three arms (20, 21, 22) provide support for a proximal end of the filter body (31) and three arms (23, 24, 25) provide support for a distal end of the filter body (31). In this many loading and deployment forces are reduced.

Description

" SUPPORT FRAME FOR EMBOLIC PROTECTION DEVICE"
This invention relates to a filter element for a transcatheter embolic protection device.
Introduction
The invention is particularly concerned with filter elements for transcatheter embohc protection devices of the type described in our previously filed PCT Patent Application No. PCT/IE98/00093 the contents of which are incorporated herein by reference. One type of such embolic filter essentially comprises a filter body mounted on an associated collapsible support frame which can be collapsed against the guide wire by means of a catheter for deployment of the filter through a patient's vascular system. Upon retraction of the catheter the support frame and filter body expand outwardly from the guidewire across a blood vessel within which the filter is positioned to filter blood flowing through the blood vessel.
The support structure is generally of shaped memory material such as nitinol which provides the circumferential pressure on expansion to secure the filter bodies in a close fit within the vessel. When the filter element is being pulled through a small diameter conduit or opening, there are certain forces exerted on the support frame. The first is on entry of the proximal end into the tube and when the whole of the proximal end has been inserted into the tube and the distal end is about to be inserted into the catheter tube. Considerable loading forces are generated which in some cases require considerable retraction forces to overcome.
The present invention is directed towards overcoming this problem. Statements of Invention
According to the invention there is provided an embolic protection device comprising:
a collapsible filter element for delivery through a vascular system of a patient;
the filter being movable between a collapsed stored position for movement through the vascular system, and an expanded position for occluding a blood vessel such that blood passing through the blood vessel is dehvered through the filter element;
the filter element comprising a collapsible filter body and a filter support frame;
the collapsible filter body having an inlet end and an outlet end, the inlet end of the filter body having one or more inlet openings sized to allow blood and embolic material enter the filter body, the outlet end of the filter body having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embohc material within the filter body;
the filter support frame being movable between a collapsed position for movement through the vascular system and an extended outwardly projecting position to support the filter body in the expanded position;
characterised in that
the filter support frame comprises a plurality of support elements, some of the support elements providing support for a first portion of the filter body and others of the support elements providing support for a second portion of the filter body.
In a preferred embodiment of the invention the first portion is a proximal portion of the filter body which is supported by proximal support elements.
In one embodiment of the invention the second portion is a distal portion of the filter body which is supported by distal support elements.
The proximal support elements preferably comprise a plurality of proximal support arms. Preferably there are three substantially equi-spaced proximal support arms.
Preferably the distal support elements comprise a plurality of distal support arms. Preferably there are three substantially equi-spaced distal support arms.
Brief Description of the Drawings
The invention will be more clearly understood by the following description of some of the embodiments thereof, given by way of example only, with reference to the accompanying drawings, in which: -
Fig. 1 is partially sectioned elevational view an embolic protection device;
Fig. 2 is a schematic sectional elevational view of the embolic protection device of Fig. 1;
Fig. 3 is a detail sectional view of portion of the device of Fig. 1;
Fig. 4 is a longitudinal cross sectional view of the device of Fig. 1; Fig. 5 is a cross sectional view of a distal end of the device of Fig. 1;
Fig. 6 is a view on the line A-A in Fig. 5;
Fig. 7 is a perspective view of a filter body of the device of Figs. 1 to 6;
Fig. 8 is a side elevational view of the filter body of Fig. 7;
Fig. 9 is a view on a proximal end of the filter body;
Fig. 10 is a perspective view of a support frame of the device of Figs. 1 to 6;
Fig. 11 is a side elevational view of the support frame;
Fig. 12 is a perspective view illustrating the manufacture of the support frame;
Fig. 13 is a view of the support frame and filter element assembly;
Fig. 14 is a longitudinal cross sectional view of a filter element according to the invention;
Fig. 15 is a longitudinal cross sectional view a support frame of the filter element of Fig. 14;
Fig. 16 is a cross sectional on the line III-III of Fig. 15;
Fig. 17 is a cross sectional view on the line IV-IV of Fig. 15;
Fig. 18 is a cross sectional view on the line V-V of Fig. 15; and Fig. 19 is a longitudinal cross section view of another support frame.
Detailed Description
Referring to Figs. 1 to 13 there is illustrated an embolic protection device as described in our co-pending Application PCT/IE98/00093 indicated generally by the reference number 100. The device 100 has a guidewire 101 with a proximal end 102 and a distal end 103. A tubular sleeve 104 is slidably mounted on the guidewire 101. A collapsible filter 105 is mounted on the sleeve 104, the filter 105 being movable between a collapsed stored position against the sleeve 104 and an expanded position as shown in the drawings extended outwardly of the sleeve 104 for deployment in a blood vessel.
The sleeve 104 is slidable on the guidewire 101 between a pair of spaced-apart end stops, namely an inner stop 106 and an outer stop which in this case is formed by a spring tip 107 at the distal end 103 of the guidewire 101.
The filter 105 comprises a filter body 110 mounted over a collapsible support frame 111. The filter body 110 is mounted to the sleeve 104 at each end, the body 110 being rigidly attached to a proximal end 112 of the sleeve 104 and the body
110 being attached to a collar 115 which is slidable along a distal end 114 of the sleeve 104. Thus the distal end of the body 110 is longitudinally slidable along the sleeve 104. The support frame 111 is also fixed at the proximal end 112 of the sleeve 104. A distal end 116 of the support frame 111 is not attached to the sleeve 104 and is thus also free to move longitudinally along the sleeve 104 to facilitate collapsing the support frame 111 against the sleeve 104. The support frame 111 is such that it is naturally expanded as shown in the drawings and can be collapsed inwardly against the sleeve 104 for loading in a catheter 118 or the like.
The filter body 105 has large proximal inlet openings 117 and small distal outlet openings 119. The proximal inlet openings 117 allow blood and embolic material to enter the filter body, however, the distal outlet openings 119 allow through passage of blood but retain undesired embolic material within the filter body.
An olive guide 120 is mounted at a distal end of the sleeve 104 and has a cylindrical central portion 121 with tapered ends 122, 123. The distal end 122 may be an arrowhead configuration for smooth transition between the catheter and olive surfaces. The support frame 111 is shaped to provide a circumferential groove 125 in the filter body 110. If the filter is too large for a vessel, the body may crease and this groove 125 ensures any crease does not propagate along the filter.
Enlarged openings are provided at a proximal end of the filter body 110 to allow ingress of blood and embolic material into an interior of the body 110.
In use, the filter 105 is mounted in a collapsed state within a distal end of the catheter 118 and delivered to a deployment site. When the filter is correctly positioned the catheter 118 is retracted allowing the support frame 111 to expand expanding the filter body 110 across the vessel in which the filter is mounted. Blood and emboli can enter the enlarged openings at a proximal end of the filter body 110. The blood will pass through the net wall, however, the openings or pores in the net are sized so as to retain the embolic material. After use the catheter is delivered along the guidewire 101 and slid over the filter 105 engaging the proximal inlet end 112 first to close the openings and then gradually collapsing the filter body against the sleeve 104 as the catheter 118 advances over the filter 105. Once the filter 105 is fully loaded in the catheter 118, it can then be withdrawn.
It will be noted that a proximal end of the filter is fixed and a distal end of the filter is longitudinally movable along the sleeve to facilitate collapsing of the filter body. Further, the catheter engages the proximal end of the filter body first thus closing the filter body inlet and preventing escape of embolic material from the filter body as the filter body is being collapsed.
The outer filter body 110 is preferably of a resilient biocompatible elastomeric material. The material may be a polyurethane based material. There are a series of commercially available polyurethane materials that may be suitable. These are typically based on polyether or polycarbonate or silicone macroglycols together with diisocyanate and a diol or diamine or alkanolamine or water chain extender. Examples of these are described in EP-A-461,375 and US 5,621, 065. In addition, polyurethane elastomers manufactured from polycarbonate polyols as described in US 5,254,622 (Szycher) are also suitable.
The filter material may also be a biostable polycarbonate urethane article an example of which may be prepared by reaction of an isocyanate, a chain extender and a polycarbonate copolymer polyol of alkyl carbonates. This material is described in our co-pending PCT Application No. IE98/00091, filed November 9,
1998, the entire contents of which are incorporated herein by reference. The filter material may be manufactured from a block and cut into a desired shape. However the filter is preferably formed by dipping a rod of desired geometry into a solution of the material which coats the rod. The rod is then dissolved. The final geometry of the filter may be determined in the dipping step or the final geometry may be achieved in a finishing operation. Typically the finishing operations involve processes such as mechanical machining operations, laser machining or chemical machining.
The filter body is of hollow construction and is formed as described above by dipping a rod in a solution of polymeric material to coat the rod. The rod is then dissolved, leaving a hollow body polymeric material. The rod may be of an acrylic material which is dissolved by a suitable solvent such as acetone. The polymeric body thus formed is machined to the shape illustrated in Figs. 1 to 13. The final machined filter body comprises an inlet or proximal portion 210 with a proximal neck 212, and oudet or distal portion 213 with a distal neck 214, and an intermediate portion 215 between the proximal and distal portions.
The inlet holes 117 are provided in the proximal portion 210 which allow the blood and embolic material to flow into the filter body. In this case the proximal portion 210 is of generally conical shape to maximise the hole size.
The intermediate portion 215 is also hollow and in this case is of generally cylindrical construction. This is important in ensuring more than simple point contact with the surrounding blood vessel. The cylindrical structure allows the filter body to come into soft contact with the blood vessel to avoid damaging the vessel wall.
The intermediate portion 215 is provided with a radial stiffening means, in this case in the form of a radial strengthening ring or rim 220. The ring 220 provides localised stiffening of the filter body without stiffening the material in contact with the vessel. Such an arrangement provides appropriate structural strength so that line apposition of the filter body to the vessel wall is achieved. It is expected that other geometries of stiffening means will achieve a similar result.
The tubular intermediate portion 215 is also important in maintaining the stability of the filter body in situ to retain captured emboli and to ensure that flow around the filter is minimised. For optimum stability we have found that the ratio of the axial length of the intermediate portion 215 of the filter body to the diameter of the intermediate portion 215 is preferably at least 0.5 and ideally greater than 1.0.
The collapsible support frame 111 has four foldable arms 290 which are collapsed for deployment and upon release extend outwardly to expand the filter body 110. The support frame 111 can be manufactured from a range of metallic or polymeric components such as a shape memory alloy like nitinol or a shape memory polymer or a shaped stainless steel or metal with similar properties that will recover from the deformation sufficiently to cause the filter body 110 to open.
The support frame may be formed as illustrated in Fig. 12 by machining slots in a tube 291 of shape memory alloy such as nitinol. On machining, the unslotted distal end of the tube forms a distal collar 293 and the unslotted proximal end of the tube forms a proximal collar 294. In use, the distal collar 293 is slidably moveable along the tubular sleeve 104 which in turn is slidably mounted on the guidewire 101 for deployment and retrieval. The proximal collar 294 is fixed relative to the tubular sleeve 104.
To load the filter the sub assembly of the support frame and filter body is pulled back into the catheter 118 to engage the distal stop 107. The support arms 290 are hinged inwardly and the distal collar 293 moves forward along the tubular sleeve 104. As the support arms 290 enter the catheter 118 the filter body 110 stretches as the filter body collar 115 slides along the tubular sleeve 104 proximal to the olive 120. On deployment, the catheter 118 is retracted proximally along the guidewire 101 initially bringing the collapsed filter assembly with it until it engages the proximal stop 106. The catheter sleeve then begins to pull off the filter freeing the support arms 290 to expand and the filter body apposes the vessel wall.
For retrieval, a retrieval catheter is introduced by sliding it over the guidewire 101 until it is positioned at the proximal end of the filter body and support frame. Pulling the guidewire 101 will initially engage the distal stop 107 with the filter element and begin to pull it into the retrieval catheter. The initial travel into the delivery catheter acts to close the proximal openings of the filter element, thus entrapping the embolic load. As the filter continues to be pulled back the filter body and the support frame are enveloped in the retrieval catheter. The collapsed filter may then be removed from the patient.
Referring to Figs. 14 to 18 there is illustrated a support frame indicated generally by the reference numeral 30 for a filter 31.
The filter support frame comprises a plurality of support elements some of which provide support for one portion of the filter body 31 and some of which provide support for another portion of the filter body 31. In this case there are six support arms, three arms 20, 21, 22 providing support for a proximal end of the filter body
31 and three arms 23, 24, 25 providing support for a distal end of the filter body 31.
In this way the loading forces are greatly reduced, while at the same time the integrity of the filter is maintained. Thus, the filter can be more easily loaded and retrieved.
Referring to Fig. 19 there is illustrated another support frame 40 similar to that of Figs. 14 to 18. In this case adequate support is provided while omitting the distal collar 293. This frame 40 is more easily formed and the same principle may be applied to other frames as those described above.
The invention is not limited to the embodiments hereinbefore described which may be varied in both construction and detail.

Claims

Claims
1. An embolic protection device comprising:
a collapsible filter element for delivery through a vascular system of a patient;
the filter being movable between a collapsed stored position for movement through the vascular system, and an expanded position for occluding a blood vessel such that blood passing through the blood vessel is delivered through the filter element;
the filter element comprising a collapsible filter body and a filter support frame;
the collapsible filter body having an inlet end and an outlet end, the inlet end of the filter body having one or more inlet openings sized to allow blood and embolic material enter the filter body, the outlet end of the filter body having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embohc material within the filter body;
the filter support frame being movable between a collapsed position for movement through the vascular system and an extended outwardly projecting position to support the filter body in the expanded position;
characterised in that
the filter support frame comprises a plurality of support elements, some of the support elements providing support for a first portion of the filter body and others of the support elements providing support for a second portion of the filter body.
2. An embolic protection device as claimed in claim 1 wherein the first portion is a proximal portion of the filter body which is supported by proximal support elements.
3. An embolic protection device as claimed in claim 1 or 2 wherein the second portion is a distal portion of the filter body which is supported by distal support elements.
4. An embolic protection device as claimed in claim 2 or 3 wherein the proximal support elements comprise a plurality of proximal support arms.
5. An embolic protection device as claimed in claim 4 wherein there are three substantially equi-spaced proximal support arms.
6. An embolic protection device as claimed in any of claims 3 to 5 wherein the distal support elements comprise a plurality of distal support arms.
7. An embolic protection device as claimed in claim 6 wherein there are three substantially equi-spaced distal support arms.
8. An embolic protection device substantially as hereinbefore described with reference to the accompanying drawings.
PCT/IE1999/000035 1999-05-07 1999-05-07 Support frame for embolic protection device WO2000067665A1 (en)

Priority Applications (31)

Application Number Priority Date Filing Date Title
PCT/IE1999/000035 WO2000067665A1 (en) 1999-05-07 1999-05-07 Support frame for embolic protection device
AU38443/99A AU3844399A (en) 1999-05-07 1999-05-07 Support frame for embolic protection device
IE20000342A IE20000342A1 (en) 1999-05-07 2000-05-08 A Filter Element
AU44264/00A AU766399B2 (en) 1999-05-07 2000-05-08 A support frame for an embolic protection device
AT00925545T ATE290830T1 (en) 1999-05-07 2000-05-08 SUPPORT FRAME FOR AN EMBOLIC PROTECTION DEVICE
DE20080306U DE20080306U1 (en) 1999-05-07 2000-05-08 Bearing frame for an empolies protection device
IL14597800A IL145978A0 (en) 1999-05-07 2000-05-08 A support frame for an embolic protection device
JP2000616702A JP2002543876A (en) 1999-05-07 2000-05-08 Support frame for embolic protection
CA002370747A CA2370747A1 (en) 1999-05-07 2000-05-08 A support frame for an embolic protection device
DE60018729T DE60018729T2 (en) 1999-05-07 2000-05-08 SUPPORT FRAME FOR AN EMULSION PROTECTION DEVICE
PCT/IE2000/000054 WO2000067669A1 (en) 1999-05-07 2000-05-08 A support frame for an embolic protection device
DE10084570T DE10084570T1 (en) 1999-05-07 2000-05-08 Bearing frame for an embolic protection device
GB0124862A GB2364918A (en) 1999-05-07 2000-05-08 A support frame for an embolic protection device
EP00925545A EP1176922B1 (en) 1999-05-07 2000-05-08 A support frame for an embolic protection device
ZA200108441A ZA200108441B (en) 1999-05-07 2001-10-15 A support frame for an embolic protection device.
US09/986,132 US20020058911A1 (en) 1999-05-07 2001-11-07 Support frame for an embolic protection device
US10/326,891 US6918921B2 (en) 1999-05-07 2002-12-23 Support frame for an embolic protection device
US10/326,920 US7014647B2 (en) 1999-05-07 2002-12-23 Support frame for an embolic protection device
US10/326,884 US6964672B2 (en) 1999-05-07 2002-12-23 Support frame for an embolic protection device
US10/797,612 US20050080446A1 (en) 1999-05-07 2004-03-11 Support frame for an embolic protection device
US11/068,044 US20050209634A1 (en) 1999-05-07 2005-03-01 Support frame for an embolic protection device
US11/068,530 US20050288705A1 (en) 1999-05-07 2005-03-01 Support frame for an embolic protection device
US11/166,803 US8002790B2 (en) 1999-05-07 2005-06-27 Support frame for an embolic protection device
US11/166,805 US7799051B2 (en) 1999-05-07 2005-06-27 Support frame for an embolic protection device
US11/505,469 US20070032817A1 (en) 1999-05-07 2006-08-17 Support frame for an embolic protection device
US11/753,928 US20070225752A1 (en) 1999-05-07 2007-05-25 Support frame for an embolic protection device
US11/753,827 US8057506B2 (en) 1999-05-07 2007-05-25 Support frame for an embolic protection device
US11/753,875 US20070233176A1 (en) 1999-05-07 2007-05-25 Support frame for an embolic protection device
US11/762,148 US7922741B2 (en) 1999-05-07 2007-06-13 Support frame for an embolic protection device
US11/762,169 US20070233178A1 (en) 1999-05-07 2007-06-13 Support frame for an embolic protection device
US11/762,314 US7867248B2 (en) 1999-05-07 2007-06-13 Support frame for an embolic protection device

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PCT/IE1999/000035 WO2000067665A1 (en) 1999-05-07 1999-05-07 Support frame for embolic protection device

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PCT/IE1999/000035 WO2000067665A1 (en) 1999-05-07 1999-05-07 Support frame for embolic protection device
PCT/IE2000/000054 WO2000067669A1 (en) 1999-05-07 2000-05-08 A support frame for an embolic protection device

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US (1) US20050288705A1 (en)
EP (1) EP1176922B1 (en)
JP (1) JP2002543876A (en)
AT (1) ATE290830T1 (en)
AU (2) AU3844399A (en)
CA (1) CA2370747A1 (en)
DE (3) DE60018729T2 (en)
GB (1) GB2364918A (en)
IL (1) IL145978A0 (en)
WO (2) WO2000067665A1 (en)
ZA (1) ZA200108441B (en)

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AU3844399A (en) 2000-11-21
AU4426400A (en) 2000-11-21
EP1176922A1 (en) 2002-02-06
CA2370747A1 (en) 2000-11-16
DE60018729D1 (en) 2005-04-21
JP2002543876A (en) 2002-12-24
ATE290830T1 (en) 2005-04-15
IL145978A0 (en) 2002-07-25
ZA200108441B (en) 2002-08-28
AU766399B2 (en) 2003-10-16
GB0124862D0 (en) 2001-12-05
GB2364918A (en) 2002-02-13
US20050288705A1 (en) 2005-12-29
DE60018729T2 (en) 2006-03-23
DE20080306U1 (en) 2002-01-10
EP1176922B1 (en) 2005-03-16
WO2000067669A1 (en) 2000-11-16
DE10084570T1 (en) 2002-04-11

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