US20050288705A1 - Support frame for an embolic protection device - Google Patents
Support frame for an embolic protection device Download PDFInfo
- Publication number
- US20050288705A1 US20050288705A1 US11/068,530 US6853005A US2005288705A1 US 20050288705 A1 US20050288705 A1 US 20050288705A1 US 6853005 A US6853005 A US 6853005A US 2005288705 A1 US2005288705 A1 US 2005288705A1
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- United States
- Prior art keywords
- distal
- proximal
- ribs
- blood vessel
- filter
- Prior art date
- Legal status (The legal status 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 status listed.)
- Abandoned
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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
- the proximal mounting may be offset with respect to the longitudinal axis of the support frame.
- FIG. 9 is a view on a proximal end of the filter body
- the construction may be made entirely of wires interconnected at various points.
Abstract
An embolic protection device 100 comprises a collapsible filter element 105 for delivery through a vascular system of a patient. The filter element 105 comprising a collapsible filter body 110 and a filter support frame 111 contacting the filter body 110. The collapsible filter body 110 has an inlet end and an outlet end, the inlet end of the filter body having one or more inlet openings 117 sized to allow blood and embolic material enter the filter body 110, the outlet end of the filter body having a plurality of outlet openings 119 sized to allow through passage of blood but to retain undesired embolic material within the filter body 110. The filter support frame 111 is movable between a collapsed position for movement through the vascular system and an extended outwardly projecting position to support the filter body 110 in the expanded position. The frame 111 has a plurality of engagement segments which are spaced-apart longitudinally and transversely when the filter body 110 is in the deployed expanded configuration to urge the filter body 110 into apposition with the vessel wall. The engagement segments define at least partially a substantially helical engagement track.
Description
- This invention relates to a filter element for a transcatheter embolic protection device.
- The invention is particularly concerned with filter elements for transcatheter embolic protection devices of the type described in our WO-A-9923976. One type of such embolic filter essentially comprises a filter body mounted on an associated collapsible support frame which can be collapsed 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 across a blood vessel within which the filter is positioned to filter blood flowing through the blood vessel.
- The support structure is generally of superelastic or shaped memory material such as nitinol which provides the circumferential pressure on expansion to secure the filter body in a close fit within the vessel.
- It is important to achieve apposition of a filter body with the wall of the vessel in which the filter is deployed to ensure that there is no pathway between the filter body and the vessel wall through which embolic material could pass. This is not a simple issue in view of the wide variations in vessel geometry and the variable physical properties of a vessel lining at different locations even within a single vasculature.
- When the filter element is being pulled through a small diameter conduit or opening for loading and retrieval, 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.
- There is therefore a need to provide a support frame for a filter which will address these problems.
- 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 element comprising a collapsible filter body and a filter support frame contacting the filter body;
- 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 embolic material within the filter body;
- the filter support frame having a longitudinal axis and 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 frame having a plurality of engagement segments, the engagement segments being spaced-apart longitudinally and transversely when the filter is in the deployed expanded configuration to urge the filter body into apposition with the vessel wall.
- In one embodiment of the invention the engagement segments define at least one at least partially substantially helical engagement track.
- Preferably the frame comprises a number of frame elements, at least some of the frame elements having an engagement segment. Ideally at least some of the frame elements are interconnected.
- In another embodiment of the invention the frame has an intermediate section and a proximal section extending from the intermediate section, the engagement segments being provided in the intermediate section of the frame. Preferably the proximal section of the frame extends radially inwardly of the intermediate section and defines at least one inlet hole to accommodate inflow of embolic material to be captured in the filter. Most preferably the proximal section of the frame has a proximal mounting for mounting on a filter carrier. Ideally the proximal mounting is substantially tubular.
- The proximal mounting may be offset with respect to the longitudinal axis of the support frame.
- In a particularly preferred embodiment the proximal section of the frame is flexible with respect to the intermediate section of the frame. Ideally the proximal section of the frame comprises a number of proximal elements, at least some of which are of a flexible material. Most preferably the proximal section of the frame comprises a plurality of flexible elements of relatively low column strength which are movable individually and independently of the intermediate section between taut and slack configuration.
- In a further embodiment of the invention the frame includes a distal section extending from the intermediate section, the distal section of the frame being flexible with respect to the intermediate section of the frame. Preferably the distal section of the frame includes a plurality of flexible elements of relatively low column strength which are movable individually and independently of the intermediate section between taut and slack configurations. Ideally the flexible elements are thread-like elements. Most preferably at least some of the flexible elements define tethers.
- In another preferred embodiment of the invention the frame has a distal section extending from the intermediate section. Preferably the distal section of the frame extends radially inwardly of the intermediate section. Ideally the distal section of the frame has a distal mounting for mounting on a filter carrier.
- The distal mounting is preferably substantially tubular.
- In one embodiment of the invention the distal mounting is offset with respect to the longitudinal axis of the support frame.
- Preferably the distal section of the frame is flexible with respect to the intermediate section of the frame.
- At least the intermediate section of the support frame may be formed from wire.
- Alternatively at least the intermediate section of the support frame may be formed by a slotted tube.
- In a preferred embodiment at least the intermediate section of the support frame is an elastic, superelastic and/or a shaped memory material. Ideally at least the intermediate section of the support frame is of Nitinol.
- Desirably the included angle defined between adjacent frame elements is less than 90°. Most preferably the included angle is less than 60°.
- In a further preferred embodiment at least a portion of a support frame element is offset from the longitudinal axis by an angle of less than 45° in the expanded configuration.
- Desirably a support frame element is offset from the longitudinal axis by an angle of less than 10° when the frame is in the collapsed configuration. Most preferably a support frame element is offset from off the longitudinal axis by angles of less than 5° when the frame is in the collapsed configuration.
- Ideally the engagement segments are defined by segments of a single frame element. The frame element is preferably at least partially of helical shape.
- Desirably the collapsible filter body is mounted to the support frame.
- In another aspect the invention provides an embolic protection device comprising:
-
- a collapsible filter element for delivery through a vascular system of a patient;
- the filter element comprising a collapsible filter body and a filter support frame contacting the filter body;
- 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 embolic material within the filter body;
- the filter support frame having a longitudinal axis and 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 frame having an intermediate section and a proximal section extending from the intermediate section; and
- the proximal section of the frame being flexible with respect to the intermediate section of the frame.
- In one embodiment of the invention the proximal section of the frame comprises a plurality of flexible elements of relatively low column strength which are movable individually and independently of the intermediate section between taut and slack configuration.
- In a preferred embodiment the frame includes a distal section extending from the intermediate section, the distal section of the frame being flexible with respect to the intermediate section of the frame. Preferably the distal section of the frame includes a plurality of flexible elements of relatively low column strength which are movable individually and independently of the intermediate section between taut and slack configurations. Ideally the flexible elements are thread-like elements.
- Most preferably at least some of the flexible elements define tethers.
- 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 ofFIG. 1 ; -
FIG. 3 is a detail sectional view of portion of the device ofFIG. 1 ; -
FIG. 4 is a longitudinal cross sectional view of the device ofFIG. 1 ; -
FIG. 5 is a cross sectional view of a distal end of the device ofFIG. 1 ; -
FIG. 6 is a view on the line A-A inFIG. 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 ofFIG. 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 ofFIG. 14 ; -
FIG. 16 is a cross sectional on the line III-III ofFIG. 15 ; -
FIG. 17 is a cross sectional view on the line IV-IV ofFIG. 15 ; -
FIG. 18 is a cross sectional view on the line V-V ofFIG. 15 ; -
FIG. 19 is a longitudinal cross section view of another support frame; -
FIG. 20 is a side elevational view of a filter support frame according to another embodiment of the invention; -
FIG. 21 is a side elevational view of another support frame of the invention; -
FIG. 21 a is a side view of one support element of the frame ofFIG. 21 ; -
FIG. 22 is a perspective view of another support frame; -
FIG. 23 is a longitudinal cross sectional view of a further support frame, in a deployed use configuration; -
FIG. 24 is a side view of another support frame in a partially collapsed configuration; -
FIG. 25 is a longitudinal cross sectional view of the support frame ofFIG. 24 in a deployed use configuration; -
FIG. 26 is a side view of another support frame; -
FIG. 27 is a side view of a still further support frame and filter of the invention; -
FIG. 28 is a perspective view of another support frame; -
FIG. 29 is a perspective view of yet another support frame; -
FIGS. 30 and 31 are side views of another support frame in different positions of use; -
FIGS. 32 and 33 are perspective views of a support frame in different positions of use; -
FIG. 34 is a perspective view of a further support frame of the invention; and -
FIG. 35 is a perspective view of the support frame ofFIG. 34 and an associated filter. - Referring to FIGS. 1 to 13 there is illustrated an embolic protection device as described in our WO-A-9923976 indicated generally by the
reference number 100. Thedevice 100 has aguidewire 101 with aproximal end 102 and adistal end 103. Atubular sleeve 104 is slidably mounted on theguidewire 101. Acollapsible filter 105 is mounted on thesleeve 104, thefilter 105 being movable between a collapsed stored position against thesleeve 104 and an expanded position as shown in the drawings extended outwardly of thesleeve 104 for deployment in a blood vessel. - The
sleeve 104 is slidable on theguidewire 101 between a pair of spaced-apart end stops, namely aninner stop 106 and an outer stop which in this case is formed by aspring tip 107 at thedistal end 103 of theguidewire 101. - The
filter 105 comprises afilter body 110 mounted over acollapsible support frame 111. Thefilter body 110 is mounted to thesleeve 104 at each end, thebody 110 being rigidly attached to aproximal end 112 of thesleeve 104 and thebody 110 being attached to acollar 115 which is slidable along adistal end 114 of thesleeve 104. Thus the distal end of thebody 110 is longitudinally slidable along thesleeve 104. Thesupport frame 111 is also fixed at theproximal end 112 of thesleeve 104. Adistal end 116 of thesupport frame 111 is not attached to thesleeve 104 and is thus also free to move longitudinally along thesleeve 104 to facilitate collapsing thesupport frame 111 against thesleeve 104. Thesupport frame 111 is such that it is naturally expanded as shown in the drawings and can be collapsed inwardly against thesleeve 104 for loading in acatheter 118 or the like. - The
filter body 105 has largeproximal inlet openings 117 and smalldistal outlet openings 119. Theproximal inlet openings 117 allow blood and embolic material to enter the filter body, however, thedistal 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 thesleeve 104 and has a cylindricalcentral portion 121 with tapered ends 122, 123. Thedistal end 122 may be an arrowhead configuration for smooth transition between the catheter and olive surfaces. Thesupport frame 111 is shaped to provide acircumferential groove 125 in thefilter body 110. If the filter is too large for a vessel, the body may crease and thisgroove 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 thebody 110. - In use, the
filter 105 is mounted in a collapsed state within a distal end of thecatheter 118 and delivered to a deployment site. When the filter is correctly positioned thecatheter 118 is retracted allowing thesupport frame 111 to expand expanding thefilter body 110 across the vessel in which the filter is mounted. Blood and emboli can enter the enlarged openings at a proximal end of thefilter body 110. The blood will pass through the filter wall, however, the openings or pores in the filter are sized so as to retain the embolic material. After use the catheter is delivered along theguidewire 101 and slid over thefilter 105 engaging theproximal inlet end 112 first to close the openings and then gradually collapsing the filter body against thesleeve 104 as thecatheter 118 advances over thefilter 105. Once thefilter 105 is fully loaded in thecatheter 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 U.S. Pat. No. 5,621,065. In addition, polyurethane elastomers manufactured from polycarbonate polyols as described in U.S. Pat. No. 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 WO-A-9924084. 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 aproximal neck 212, and outlet ordistal portion 213 with adistal neck 214, and anintermediate 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 theproximal 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 geometrics 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 theintermediate portion 215 of the filter body to the diameter of theintermediate portion 215 is preferably at least 0.5 and ideally greater than 1.0. - The
collapsible support frame 111 has fourfoldable arms 290 which are collapsed for deployment and upon release extend outwardly to expand thefilter body 110. - The
support frame 111 can be manufactured from a range of metallic or polymeric components such as a superelastic or 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 thefilter body 110 to open. - The support frame may be formed as illustrated in
FIG. 12 by machining slots in atube 291 of superelastic material or shape memory alloy such as nitinol. On machining, the unslotted distal end of the tube forms adistal collar 293 and the unslotted proximal end of the tube forms aproximal collar 294. In use, thedistal collar 293 is slidably moveable along thetubular sleeve 104 which in turn is slidably mounted on theguidewire 101 for deployment and retrieval. Theproximal collar 294 is fixed relative to thetubular sleeve 104. - Alternatively, the construction may be made entirely of wires interconnected at various points.
- To load the filter, the sub assembly of the support frame and filter body is pulled back into the
catheter 118 to engage thedistal stop 107. Thesupport arms 290 are hinged inwardly and thedistal collar 293 moves forward along thetubular sleeve 104. As thesupport arms 290 enter thecatheter 118 thefilter body 110 stretches as thefilter body collar 115 slides along thetubular sleeve 104 proximal to the olive 120. On deployment, thecatheter 118 is retracted proximally along theguidewire 101 initially bringing the collapsed filter assembly with it until it engages theproximal stop 106. The catheter sleeve then begins to release the filter freeing thesupport 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 theguidewire 101 will initially engage thedistal 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. - Various support frames according to the invention are described below with reference to FIGS. 14 to 35. In each case the frame has a plurality of engagement segments formed on one or more support arms (some of which may be interconnected). The engagement segments are spaced-apart longitudinally and transversely when the filter is in the deployed expanded configuration to urge the filter body into apposition with the vessel wall. The support frames of the invention provide apposition of the filter body to the wall of a vessel in which the filter is deployed. This is achieved while reducing the loading forces required to load the filter into a delivery catheter for deployment and for loading the filter into a retrieval catheter for retrieval of the filter together with any embolic material captured by the filter.
- Referring to FIGS. 14 to 18 there is illustrated a support frame indicated generally by the
reference numeral 30 for afilter 31. Thefilter support frame 30 comprises a plurality of support elements each of which extend in a longitudinal direction. Some of the support elements provide support for one portion of thefilter body 31 and some provide support for another portion of thefilter body 31. In this case there are six support arms, threearms filter body 31 and threearms filter body 31. Thesupport arms - Referring to
FIG. 19 there is illustrated anothersupport frame 40 similar to that of FIGS. 14 to 18. In this case adequate support is provided while omitting thedistal collar 293. Thisframe 40 is easily formed and the same principle may be applied to other frames as those described above and below. - Referring to
FIG. 20 there is illustrated anothersupport frame 50 which comprises foursupport arms arms different engagement segments - Referring to
FIG. 21 there is illustrated anothersupport frame 55 according to the invention. Thesupport frame 55 comprises sixsupport elements 56, one of which is shown inFIG. 21 (a). Eachelement 56 includes a distal orproximal tether section 57 and aclosed loop portion 58 extending from thetether section 57. Theloops 58 haveengagement sections 59 and the engagement sections of the frame are longitudinally and transversely spaced-apart to achieve apposition in a central section of theframe 55. - Referring to
FIG. 22 there is illustrated afurther support frame 60 comprising sixseparate support elements engagement segments - Referring to
FIG. 23 anothersupport frame 70 of the invention is made from twisted wires of a shaped memory/superelastic material such as nitinol. In this there are four support elements, each provided by atwisted wire 71. Thewires 71 are joined together by twisting at proximal and distal ends. Thewires 71 are joined together in a central region between the distal and proximal ends to form a lattice-like structure 72 which defines a plurality of longitudinally and transversely spaced-apart engagement segments. - Referring to
FIG. 24 there is illustrated asupport frame 75 which is in the form of a lattice-like arrangement to achieve substantial apposition to a vessel wall in use as illustrated inFIG. 25 . - In
FIG. 26 there is illustrated asupport frame 76 similar to theframe 75 ofFIGS. 24 and 25 . In this case the lattice in a central region is of generally hexagonal shape. - Referring to
FIG. 27 there is illustrated a filter comprising afilter membrane 78 supported by a support frame 79. The support frame 79 comprises a distal lattice portion 79 a, aproximal lattice portion 79 b and a series of interconnecting struts in acentral portion 79 c. In this case the support frame 79 is attached byconnections 80 to thefilter membrane 78. The filter support frame 79 is mounted to the filter body and is independent of the guidewire. Therefore lateral movement of the guidewire will not affect the position of the filter support frame and apposition will not be adversely affected by guidewire movement. - Referring to
FIG. 28 anothersupport frame 82 according to the invention comprises a number of frame elements which divide intermediate the proximal and distal ends intoloops 83 which define engagement segments. - In
FIG. 29 there is illustrated anothersupport frame 85 similar to the frame ofFIG. 28 and like parts are assigned the same reference numerals. In this case theframe elements 82 are not interconnected at the distal end. - Referring now to
FIGS. 30 and 31 there is illustrated anotherfilter support frame 85 according to the invention which is similar to the embodiment ofFIG. 21 described above and like parts are assigned the same reference numerals. In this case the filter frame is proximally connected by means of two or more, preferably three flexible, (low column strength) threads/monofilaments 86. Thethreads 86 may be moved individually and independently of the intermediate section between a slack and taut configurations. This allows for a greater freedom of movement of the guidewire relative to the centre of the lumen without distorting the filter element. This is particularly advantageous in curved vasculatures where the guidewire may have the tendency to move away from the centre of the lumen, or in embodiments such as offset filters where the delivery of interventional catheters proximal to the filter may cause the guidewire to move towards the centre thus causing the filter to distort. - Referring to
FIGS. 32 and 33 there is illustrated an offsetfilter 90 according to the invention. The frame may be of nitinol wire of slotted tube configuration. One ormore support elements 91 define a loop like structure at an angle at the proximal end to define aproximal inlet hole 92. The design for the intermediate and the distal sections of the filter may vary. In the embodiment illustrated there are twosupport elements 91 which form a partial helical structure along the periphery of the filter membrane. The offset design allows for a single, large proximal hole diameter, thus enabling the capture of large emboli and also maximum space for blood flow within the filter. The guidewire enters the filter through a proximal collar off the centre of the vasculature. - Referring to
FIGS. 34 and 35 there is illustrated another offsetfilter 95 according to the invention which is similar to the filter ofFIGS. 32 and 33 . In this case there is asingle support element 96. The membrane is self supported at the distal end. - The support frame may comprise one or a number of support elements extending in a substantially longitudinal direction. In a preferred embodiment, at least a portion of the longitudinal support element is offset by less than 45° from its longitudinal axis. This provides circumferential apposition while greatly reducing the loading forces. In its collapsed configuration, the support elements are preferably offset within 10° preferably within 5° of the longitudinal axis.
- It will be appreciated that the local stiffeners of the support element can be reduced in the collapsed state by having an undulating/curved section about which the collapsed filter can bend. This provides increased flexibility during delivery in an arrangement such as that of
FIG. 20 described above. - The invention is not limited to the embodiments hereinbefore described which may be varied in both construction and detail.
Claims (30)
1-40. (canceled)
41. A system for enabling the capture of embolic material which may be released into a blood vessel during a therapeutic interventional procedure, comprising:
a guide wire, including a distal end, adapted to be positioned within the blood vessel and to extend to a position distal to the interventional procedure site; and
a filter device, adapted to be positioned and deployed at a location in the patient's vasculature distal to the interventional procedure site, and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, including an articulating element, for enabling the filter device to articulate so as to move and flex during insertion through the blood vessel, and to expand against the inner surface of the wall of the blood vessel, and seal off the inner surface of the blood vessel wall, upon expansion of the filter device for deployment thereof, so as to inhibit the formation of a gap between the filter device and the blood vessel wall through which embolic material may otherwise flow.
42. The system of claim 41 , wherein the filter device includes a cage, secured to the distal end of the guide wire, and filter material, for filtering embolic material, secured to the cage.
43. The system of claim 41 , wherein the cage includes a plurality of struts, each of which includes a plurality of proximal ribs, a plurality of distal ribs, and a ring which extends intermediate the plurality of proximal ribs and the plurality of distal ribs, which forms a proximal junction between the plurality of proximal ribs, and a distal junction between the plurality of distal ribs, and wherein the articulating element includes a proximal articulating element, located at the proximal junction, and a distal articulating element, located at the distal junction.
44. The system of claim 43 , further comprising a fitting, secured to the distal end of the guide wire, and wherein the plurality of proximal ribs are connected to the fitting.
45. The system of claim 43 , wherein the ring includes a plurality of segments, each of which includes a proximal portion and a distal portion, and wherein each pair of segments which are adjacent to each other at the proximal ends thereof comprise proximal adjacent segments, and each pair of segments which are adjacent to each other at the distal ends thereof comprise distal adjacent segments.
46. The system of claim 45 , wherein each of the plurality of proximal ribs includes a distal portion, each of the plurality of distal ribs includes a proximal portion, each pair of proximal adjacent segments form a junction therebetween which comprises a proximal junction, the proximal junction is in the form of a partial loop which comprises a proximal partial loop, the distal portion of each of the plurality of proximal ribs is in the form of a loop which comprises a distal loop, and each distal loop is engaged with each proximal partial loop comprising proximal engaged loops
and partial loops, each pair of distal adjacent segments form a junction therebetween which comprises a distal junction, the distal junction is in the form of a partial loop which comprises a distal partial loop, the proximal end of each of the plurality of distal ribs is in the form of a loop which comprises a proximal loop, and each proximal loop is engaged with each distal partial loop, comprising distal engaged loops and partial loops, and wherein the proximal articulating element comprises the proximal engaged loops and partial loops, and the distal articulating element comprises the distal engaged loops and partial loops.
47. The system of claim 45 , wherein the plurality of segments of the ring define a contour thereof.
48. The system of claim 47 , wherein the filter device includes filter material, secured to the plurality of segments of the ring, the filter material includes a proximal portion and a distal portion, and the proximal portion of the filter material includes a contour which corresponds generally to the contour defined by the plurality of segments of the ring.
49. The system of claim 47 , wherein the contour defined by the plurality of segments of the ring is generally right-angle-bracket shaped.
50. The system of claim 41 , wherein the cage includes a plurality of struts, each of which includes a plurality of proximal ribs, a plurality of distal ribs, and a ring which extends intermediate the plurality of proximal ribs and the plurality of distal ribs, which forms a distal junction between the plurality of distal ribs, and
wherein the articulating element comprises a distal articulating element, located at the distal junction.
51. The system of claim 50 , wherein the ring includes a plurality of segments, each of which includes a proximal portion and a distal portion, and wherein each pair of segments which are adjacent to each other at the distal ends thereof comprise distal adjacent segments.
52. The system of claim 51 , wherein each of the plurality of proximal ribs includes a distal portion, each of the plurality of distal ribs includes a proximal portion, each pair of distal adjacent segments form a junction therebetween which comprises a distal junction, the distal junction is in the form of a partial loop which comprises a distal partial loop, the proximal end of each of the plurality of distal ribs is in the form of a loop, which comprises a proximal loop, and each proximal loop is engaged with each distal partial loop comprising distal engaged loops and partial loops, and wherein the distal articulating element comprises the distal engaged loops and partial loops.
53. The system of claim 51 , wherein the plurality of segments of the ring define a contour thereof.
54. The system of claim 53 , wherein the filter device includes filter material, secured to the plurality of segments of the ring, the filter material includes a proximal portion and a distal portion, and the proximal portion of the filter material includes a contour which corresponds generally to the contour defined by the plurality of segments of the ring.
55. The system of claim 53 , wherein the contour defined by the plurality of segments of the ring is generally right-angle-bracket shaped.
56. The system of claim 41 , wherein the cage includes a plurality of struts, each of which includes a plurality of proximal ribs, a plurality of distal ribs, and a ring which extends intermediate the plurality of proximal ribs and the plurality of distal ribs, which forms a proximal junction between the plurality of proximal ribs, and wherein the articulating element comprises a proximal articulating element, located at the proximal junction.
57. The system of claim 56 , wherein the ring includes a plurality of segments, each of which includes a proximal portion and a distal portion, and wherein each pair of segments which are adjacent to each other at the proximal ends thereof comprise proximal adjacent segments.
58. The system of claim 57 , wherein each of the plurality of proximal ribs includes a distal portion, each of the plurality of distal ribs includes a proximal portion, each pair of proximal adjacent segments form a junction therebetween which comprises a proximal junction, the proximal junction is in the form of a partial loop which comprises a proximal partial loop, the distal portion of each of the plurality of proximal ribs is in the form of a loop, which comprises a distal loop, and each distal loop is engaged with each proximal partial loop comprising proximal engaged loops and partial loops, and wherein the proximal articulating element comprises the proximal engaged loops and partial loops.
59. The system of claim 57 , wherein the plurality of segments of the ring define a contour thereof.
60. The system of claim 59 , wherein the filter device includes filter material, secured to the plurality of segments of the ring, the filter material includes a proximal portion and a distal portion, and the proximal portion of the filter material includes a contour which corresponds generally to the contour defined by the plurality of segments of the ring.
61. The system of claim 59 , wherein the contour defined by the plurality of segments of the ring is generally right-angle-bracket shaped.
62. A system for enabling the capture of embolic material which may be released into a blood vessel during a therapeutic interventional procedure, comprising:
a guide wire, including a distal end, adapted to be positioned within the blood vessel and to extend to a position distal to the interventional procedure site; and
a filter device, adapted to be positioned and deployed at a location in the patient's vasculature distal to the interventional procedure site, and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, including an articulating element, for enabling the filter device to be inserted through the blood vessel so as to move and flex to articulate therein, for enabling the filter device to navigate through confined spaces therein.
63. The system of claim 62 , wherein the filter device includes a cage, secured to the distal end of the guide wire, and filter material, for filtering embolic material, secured to the cage.
64. The system of claim 63 , wherein the cage includes a plurality of struts, each of which includes a plurality of proximal ribs, and wherein each of the plurality of proximal ribs includes the articulating element therein.
65. The system of claim 64 , wherein each of the plurality of proximal ribs includes a proximal end and a distal end, and the articulating element comprises a generally u-shaped portion of the proximal portion of each of the plurality of proximal ribs, spaced from the proximal end and the distal end thereof.
66. The system of claim 64 , wherein each of the plurality of proximal ribs includes a proximal end and a distal end, and the articulating element comprises a generally w-shaped portion of the proximal portion of each of the plurality of proximal ribs, spaced from the proximal end and the distal end thereof.
67. A method of enabling the capture of embolic material which may be released into a blood vessel during a therapeutic interventional procedure, in a system which comprises a guide wire, including a distal end, adapted to be positioned within the blood vessel and to extend to a position distal to the interventional procedure site, and a filter device, adapted to be positioned and deployed at a location in the patient's vasculature distal to the interventional procedure site, and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, including an articulating element, for enabling the filter device to articulate so as to move and flex during insertion through the blood vessel, and to expand against the inner surface of the wall of the blood vessel, and seal off the inner surface of the blood vessel wall, upon expansion of the filter device for deployment thereof, so as to inhibit the formation of a gap between the filter device and the blood vessel wall through which embolic material may otherwise flow, wherein the method comprises:
inserting the guide wire, and the filter device secured to the distal end thereof, through the blood vessel, to the position distal to the interventional procedure site; and
deploying the filter device at the position distal to the interventional procedure site, wherein the articulating element articulates, enabling the filter device to expand against the inner surface of the wall of the blood vessel, and seal off the inner surface of the blood vessel wall, so as to inhibit the formation of a gap between the filter device and the blood vessel wall through which embolic material may otherwise flow.
68. A method of enabling the capture of embolic material which may be released into a blood vessel during a therapeutic interventional procedure, in a system which comprises, a guide wire, including a distal end, adapted to be positioned within the blood vessel and to extend to a position distal to the interventional procedure site, and a filter device, adapted to be positioned and deployed at a location in the patient's vasculature distal to the interventional procedure site, and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, including an articulating element, for enabling the filter device to be inserted through the blood
vessel so as to move and flex to articulate therein, for enabling the filter device to navigate through confined spaces therein, wherein the method comprises:
inserting the guide wire, and the filter device secured thereto and unexpanded within a delivery sheath, through the blood vessel, to the position distal to the interventional procedure site, wherein the articulating element articulates, enabling the filter device to navigate through confined spaces in the blood vessel; and
deploying the filter device at the position distal to the interventional procedure site.
69-101. (canceled)
Priority Applications (1)
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PCT/IE2000/000054 WO2000067669A1 (en) | 1999-05-07 | 2000-05-08 | 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 |
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US86479604A | 2004-06-10 | 2004-06-10 | |
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Also Published As
Publication number | Publication date |
---|---|
WO2000067669A1 (en) | 2000-11-16 |
EP1176922A1 (en) | 2002-02-06 |
AU766399B2 (en) | 2003-10-16 |
ZA200108441B (en) | 2002-08-28 |
DE10084570T1 (en) | 2002-04-11 |
IL145978A0 (en) | 2002-07-25 |
AU3844399A (en) | 2000-11-21 |
GB2364918A (en) | 2002-02-13 |
WO2000067665A1 (en) | 2000-11-16 |
EP1176922B1 (en) | 2005-03-16 |
ATE290830T1 (en) | 2005-04-15 |
DE20080306U1 (en) | 2002-01-10 |
AU4426400A (en) | 2000-11-21 |
GB0124862D0 (en) | 2001-12-05 |
DE60018729D1 (en) | 2005-04-21 |
JP2002543876A (en) | 2002-12-24 |
CA2370747A1 (en) | 2000-11-16 |
DE60018729T2 (en) | 2006-03-23 |
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