Patent Description:
In recent years, a number of medical devices have been designed which are adapted for compression into a small size to facilitate introduction into a vascular passageway and which are subsequently expandable into contact with the walls of the passageway. These devices, among others, include blood clot filters which expand and are held in position by engagement with the inner wall of a vein, such as the vena cava. These vena cava filters are designed to remain in place permanently. Such filters include structure to anchor the filter in place within the vena cava, such as elongate diverging anchor members with hooked ends that penetrate the vessel wall and positively prevent migration in either direction longitudinally of the vessel. The hooks on filters of this type are rigid and will not bend, and within two to six weeks after a filter of this type has been implanted, the endothelium layer grows over the diverging anchor members and positively locks the hooks in place. Now any attempt to remove the filter results in a risk of injury to or rupture of the vena cava.

A number of conditions and medical procedures subject the patient to a short term risk of pulmonary embolism which can be alleviated by a filter implant. In such cases, patients are often averse to receiving a permanent implant, for the risk of pulmonary embolism may disappear after a period of several weeks or months. However, most existing filters are not easily or safely removable after they have remained in place for more than several weeks, and consequently longer-term temporary filters that do not result in the likelihood of injury to the vessel wall upon removal are not available.

In an attempt to provide a removable filter, two filter baskets have been formed along a central shaft that are conical in configuration, with each basket being formed by spaced struts radiating outwardly from a central hub for the basket. The central hubs are held apart by a compression unit, and the locator members of the two baskets overlap so that the baskets face one another. Filters of this type require the use of two removal devices inserted at each end of the filter to draw the baskets apart and fracture the compression unit. The end sections of the locator members are formed to lie in substantially parallel relationship to the vessel wall and the tips are inclined inwardly to preclude vessel wall penetration. If a device of this type is withdrawn before the endothelium layer grows over the locator members, vessel wall damage is minimized. However, after growth of the endothelium layer the combined inward and longitudinal movement of the filter sections as they are drawn apart can tear this layer.

Each of the following patents and published patent applications relate to IVC or blood filters: <CIT>; <CIT>; <CIT>; <CIT> ; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>. <CIT> describes a removable blood clot filter includes a number of locator members and anchor members disposed radially and extending angularly downward from a hub. The locator members include a number of linear portions having distinct axes configured to place a tip portion approximately parallel to the walls of a blood vessel when implanted and to apply sufficient force to the vessel walls to position the filter near the vessel centerline. The anchor members each include a hook configured to penetrate the vessel wall to prevent longitudinal movement due to blood flow. The hooks may have a cross section sized to allow for a larger radius of curvature under strain so that the filter can be removed without damaging the vessel wall. <CIT> describes an embolic filter is disclosed and can include a head. A plurality of bent legs can extend from the head. Each bent leg can be configured to engage an inner wall of a vein and prevent the embolic filter from migrating in a cranial direction. A plurality of straight legs can also extend from the head. Each straight leg can be configured to prevent the embolic filter from migrating in a caudal direction. <CIT> describes a thrombus filter configured for placement within a blood vessel lumen. The filter having a longitudinal axis. The filter includes first and second units, each unit including a plurality of elongated struts. Each strut has a joining end where the respective struts of each unit are joined together. Each strut also has a free end opposite the joining end. The struts have at least two curves such that in a longitudinal planar projection of the filter, each strut has a first direction of curvature proximate the joining end and an opposite direction of curvature closer to the free end. In a transverse planar projection of the filter, the strut has a first direction of curvature proximate the joining and an opposite direction of curvature closer to the free end. The units can be coupled together in opposition such that the free ends of the struts of the first unit are generally oriented in a first longitudinal direction and the free ends of the struts of the second unit are generally oriented in the opposite longitudinal direction. <CIT> describes a compact retrievable blood clot filter and a method of retrieving the filter. The retrievable filter has a primary hub, a set of filter struts having a conical configuration and extending from the primary hub, and a set of alignment struts connected to the filter struts to provide centering of the filter. A set of control struts connected to the alignment struts has a secondary hub which is axially movable relative to the primary hub. Movement of the secondary hub causes the control struts to pull the alignment struts radially inward into a retractable state for retrieval of the filter. <CIT> describes intravascular filtering devices for placement within a blood vessel are disclosed. An intravascular filter in accordance with the present invention may include a plurality of elongated filter legs biased to radially expand from a collapsed position to a conical-shaped position when deployed in a blood vessel. Each of the filter legs may include a hook region configured to engage the vessel wall. The filter legs may vary in length and/or cross-sectional diameter. In certain embodiments, the dimensions and/or orientation of the hook regions can be configured to allow the filter device to be collapsed into a relatively small introducer catheter or sheathand
<CIT> is concerned with a filter delivery device for implanting a vessel filter within a blood vessel of a patient's body. The filter delivery device includes a mechanism for preventing hooks and/or legs on a vessel filter from entangling with each other while the vessel filter is loaded within the delivery device. In one variation, the filter delivery device includes a delivery catheter with grooves at the distal end lumen opening. When a vessel filter with radially expanding legs is compressed and inserted into the distal end of the delivery catheter, the hooks on the distal end of the legs are received and separated by the corresponding grooves on the delivery catheter. In another variation, a pusher rod, with a receptacle for receiving the hooks, is positioned within a delivery catheter to prevent the entanglement of the hooks and/or legs of a filter loaded within the delivery catheter.

In one embodiment there is provided a filter to be placed in a flow of blood through a vessel, comprising: a hub disposed along a longitudinal axis; a plurality of anchor members extending from the hub, at least one anchor member distal end spaced from the hub at each of a first, second, and third distance along the longitudinal axis; and a plurality of locator members, each locator member extending from the hub between an adjacent pair of anchor members; and characterized in that: each anchor member includes either a cranial extension or a caudal extension at a distal end thereof, and wherein the cranial extensions include a cranial hook and a cranial limiter extending separately from a cranial base having a width greater than a width of the anchor member, and wherein the caudal extensions (<NUM>) include a caudal anchor (<NUM>) and a caudal limiter (<NUM>) extending separately from a caudal base (<NUM>) having a width greater than a width of the anchor member (<NUM>).

The various embodiments may further include a radio-opaque material on or as part of the filter hub. Also, the various embodiments described above may further include a bio-active agent incorporated with or as part of the filter.

The various embodiments further provide for a method of preparing a blood filter for insertion into a body vessel, including folding/positioning the filter in a compact, small profile in order to provide space for filter hooks and anchors to reside, and also in order to prevent filter hooks and anchors from interfering with loading and/or delivery of the blood filter.

In one embodiment, a method of preparing the filter for delivery into a body vessel, the filter having six anchor members comprising first, second, third, fourth, fifth, and sixth anchor members arranged successively counterclockwise about a circumference of the hub when viewed from the anchor member distal ends, the filter further having six locator members comprising first, second, third, fourth, fifth, and sixth locator members arranged successively counterclockwise about a circumference of the hub when viewed from the anchor member distal ends, includes: (i) constraining the anchor members in a collapsed configuration; (ii) positioning a length of the first locator member closest clockwise of the first anchor member behind the first anchor member and the second anchor member such that a distal end of the first locator member extends between the second anchor member and the third anchor member; (iii) positioning a length of the second locator member behind the second anchor member and the third anchor member such that a distal end of the second locator member extends between the third anchor member and the fourth anchor member; (iv) positioning a length of the third locator member behind the third anchor member and the fourth anchor member such that a distal end of the third locator member extends between the fourth anchor member and the fifth anchor member; (v) positioning a length of the fourth locator member behind the fourth anchor member and the fifth anchor member such that a distal end of the fourth locator member extends between the fifth anchor member and the sixth anchor member; (vi) positioning a length of the fifth locator member behind the fifth anchor member and the sixth anchor member such that a distal end of the fifth locator member extends between the sixth anchor member and the first anchor member; (vii) positioning a length of the sixth locator member behind the sixth anchor member and the first anchor member such that a distal end of the sixth locator member extends between the first anchor member and the second anchor member; (viii) verifying that the anchor members with caudal extensions are surrounded by the anchor members with cranial extensions; and (ix) pulling the filter into a delivery sheath.

In one embodiment, a method of preparing the filter for delivery into a body vessel, the filter comprising N anchor members extending distally from a hub, the anchor members arranged and numbered successively counterclockwise about a circumference of the hub when viewed from a filter distal end, each anchor member including either a cranial extension or a caudal extension at a distal end thereof, and N locator members extending distally from the hub, the locator members arranged and numbered successively counterclockwise about a circumference of the hub when viewed from the filter distal end, each locator member extending from the hub between an adjacent pair of anchor members arranged such that locator member n is positioned immediately clockwise adjacent of anchor member n, wherein N is greater than <NUM>, includes: (i) constraining the anchor members in a collapsed configuration; (ii) positioning a length of locator member <NUM> behind anchor member <NUM> and anchor member <NUM> such that a distal end of locator member <NUM> extends between anchor member <NUM> and anchor member <NUM>; (iii) repeating step (ii) for locator members <NUM>, <NUM>,. , and N-<NUM>; (iv) positioning a length of locator member N-<NUM> behind anchor member N-<NUM> and anchor member N such that a distal end of locator member N-<NUM> extends between anchor member N and anchor member <NUM>; (v) positioning a length of locator member N behind anchor member N and anchor member <NUM> such that a distal end of locator member N extends between anchor member <NUM> and anchor member <NUM>; (vi) verifying that the anchor members with caudal extensions are surrounded by the anchor members with cranial extensions; and (vii) pulling the filter into a delivery sheath.

These and other embodiments, features and advantages will become more apparent to those skilled in the art when taken with reference to the following more detailed description of the invention in conjunction with the accompanying drawings that are first briefly described.

The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate examples for understanding the invention and presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain features of the invention.

As used herein, the terms "about" or "approximately" for any numerical values or ranges indicates a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. Also, as used herein, the terms "patient", "host" and "subject" refer to any human or animal subject and are not intended to limit the systems or methods to human use, although use of the subject invention in a human patient represents a preferred embodiment.

Referring to <FIG>, a filter <NUM> is illustrated in a perspective view. The filter <NUM> includes a hub <NUM>, locator member <NUM>, and anchor member <NUM> that has a hook <NUM>. The filter <NUM> can be made from a plurality of elongate wires, which are preferably metal, such as, for example, Elgiloy, and more preferably are a super elastic shape memory alloy, such as Nitinol. The wires are held together at the filter trailing end by a hub <NUM> by a suitable connection technique, such as, for example, welding, laser welding, or plasma welding or being bonded together. Preferably, the wires are plasma welded. As used herein, "wire" refers to any elongated member of narrow cross section, including rods, bars, tubes, wire and narrow sections cut from thin plate, and is not intended to limit the scope of the invention to elongated members of circular cross section, cut from wire stock or manufacture according to a particular method of metal forming.

The locator member <NUM> has a proximal locator end 20P and a distal locator end 20D. Similarly, the anchor member <NUM> has a proximal anchor end 30P and a distal anchor end 30D. The distal anchor end 30D can be provided, as shown in <FIG>, with hook <NUM>.

Referring to <FIG> and <FIG>, the locator member <NUM> may be provided with a plurality of locator segments, preferably between <NUM> and <NUM> segments and more preferably four locator segments LS1, LS2, LS3, LS4. First locator segment LS1 may be a curved portion extending away from the hub in a first direction along the longitudinal axis A. In an embodiment, the second locator segment LS2 extends generally linearly along a second axis <NUM>; third locator segment LS3 extends generally linearly along a third axis <NUM>; and the fourth locator segment LS4 extends generally linearly along a fourth axis <NUM>. In a preferred embodiment, the various axes A, <NUM>, <NUM>, <NUM>, and <NUM> are distinct from one another in that each may intersect with one another but none of them are substantially collinear with each other.

The locator segment LS2 may be distinct from locator segment LS3 by virtue of a joint or bend LJ1. The locator segment LS3 may be distinct from locator segment LS4 via a join or bend LJ2. The joint or bend LJ1 or LJ2 can be viewed as a location formed by the intersection of the segments defining a radiused portion connecting any two segments.

The locators <NUM> may range from <NUM> to <NUM> locators. The filter embodiment illustrated in <FIG> includes six locators that are generally equiangularly spaced about axis A. In the embodiment illustrated in <FIG>, locator segment LS1 extends through an arc with a radius of curvature R1 whose center may be located along an axis orthogonal to axis A over a radially transverse distance d3 and over a longitudinal distance L4 as measured from a terminal surface <NUM> of the hub <NUM> along an axis generally parallel to the longitudinal axis A. The locator segment LS2 extends along axis <NUM> to form a first angle θ1 with respect to the longitudinal axis A whereas the locator segment LS3 extends along axis <NUM> to form second angle θ2. As shown in <FIG>, the first locator joint or bend LJ1 may be located at a longitudinal length L1 generally parallel to axis A from the terminal surface <NUM>. The first locator joint or bend LJ1 may be also located at a distance of about one-half distance "d<NUM> "from axis A on a generally orthogonal axis with respect to axis A as shown in <FIG> , where the distance d<NUM> is the distance between inside facing surfaces of respective diametrically disposed locators <NUM>, The second locator joint LJ2 may be located over a longitudinal length L2 generally parallel to axis A. The second locator join LJ2 may be located over a distance of about one-half diameter "d<NUM> " from axis A. The distance d2 is the distance between the outermost surface of the fourth segment LS4 of respective diametrically disposed locators <NUM>. The thickness of locator member <NUM> is t<NUM>. Where the locator member <NUM> is a wire of circular cross-section, the thickness t<NUM> of the locator <NUM> may be the diameter of the wire.

A range of values may be used for the aforementioned dimensional parameters in order to provide locator members that will locate the filter within the vein or vessel in which the filter is to be applied in a manner that positions segment LS4 approximately parallel to the walls of the vein or vessel and provides sufficient lateral force against the vein or vessel wall to center the filter but not so much force as to cause injury to the wall. For example, a filter intended to be placed in a narrow vein or vessel, such as a human infant or canine vena cava, may have smaller dimensions L<NUM>, L<NUM>, L<NUM>, L<NUM>, LS1, LS2, LS3, LS4, d<NUM> and d<NUM> so that the positioning members can deploy sufficiently to accomplish the positioning and filtering functions, than a filter intended to be placed in a large vein or vessel, such as an adult human vena cava or other vessel. In an example embodiment suitable for an adult human vena cava filter, when the filter is at the temperature of the subject and unconstrained, the radius of curvature R1 is from about <NUM> (<NUM> inches) to about <NUM> (<NUM> inches) with the center of the radius R<NUM> being located over a distance d<NUM> from the axis A of about <NUM> (<NUM> inches) and length L<NUM> of about <NUM> (<NUM> inches); the length L<NUM> is about <NUM> (<NUM> inches); length L<NUM> is about <NUM> (<NUM> inches); distance d<NUM> (as measured to the inside facing surfaces of diametrically disposed locators <NUM>) is about <NUM>,<NUM> (<NUM> inches); distance d<NUM> is about <NUM> (<NUM> inches), the first angle θ<NUM> is about <NUM> degrees, the second angle θ2 is about <NUM> degrees; and the thickness t1 of the locator is about <NUM> (<NUM> inches). It should be noted that the values given herein are approximate, representing a dimension within a range of suitable dimensions for the particular embodiment illustrated in the figures, and that any suitable values can be used as long as the values allow the filter to function as intended in a blood vessel of a subject.

Referring to <FIG> and <FIG>, the hub <NUM> can be provided with an internal cylindrical opening with a diameter of about two times the distance d<NUM>. Each of the plurality of anchor members <NUM> can be provided with a first anchor segment LA1, a portion of which is disposed within the hub <NUM>, connected to a second anchor segment LA2 by a first anchor joint or bend AJ1, which can be connected to a third anchor segment LA3 via a second anchor joint or bend AJ2. The third anchor segment LA3 can be connected to the hook <NUM> via third anchor joint or bend AJ3. The first anchor segment LA1 extends obliquely with respect to axis A. The second anchor segment LA2 extends along axis <NUM> oblique with respect to the axis A over an angle θ<NUM> with respect to the longitudinal axis A. The third anchor segment LA3 extends along axis <NUM> oblique with respect to the longitudinal axis A over an angle θ<NUM>. The second anchor joint or bend AJ2 can be located at a sixth longitudinal distance L6 as measured on an axis generally parallel to the axis A from the terminal surface <NUM> of the hub <NUM> and at about one half the fourth distance d<NUM> as measured between generally diametrical end points of two anchors <NUM> on an axis generally orthogonal to the axis A. The third anchor joint AJ3 can be located at a seventh longitudinal distance L as measured along an axis generally parallel to axis A and at a transverse distance of about one-half distance d<NUM> as measured on an axis orthogonal to the axis A between the inner surfaces of two generally diametric anchors <NUM>, The thickness of anchor member <NUM> is nominally t<NUM>. Where the anchor member <NUM> is a wire of circular cross-section, the thickness t<NUM> of the anchor <NUM> may be the diameter of the wire. As shown in <FIG>, the hook <NUM> may be contiguous to a plane located at a longitudinal distance of L10 as measured to the terminal surface <NUM> of hub <NUM>. The hook <NUM> can be characterized by a radius of curvature R<NUM>, in its expanded configuration at a suitable temperature, e.g., room temperature or the internal temperature of a subject. The center of the hook curvature R<NUM> can be located at a distance L<NUM> as measured along an axis generally parallel to the axis A from the terminal surface <NUM> of hub <NUM> and at one-half distance d6 as measured between two generally diametrical hooks <NUM>. The tips 40T of respective diametric hooks <NUM> may be located at longitudinal distance L<NUM> (which may be approximately the same as longitudinal distance L<NUM> to the third anchor joint AJ3) and at one half of distance d<NUM> between diametric hooks <NUM>.

A range of values may be used for the aforementioned dimensional parameters in order to provide anchor members that will locate and anchor the filter within the vein or vessel in which the filter is to be applied in a manner that positions hooks <NUM> in contact with the walls of the vein or vessel and provides sufficient lateral force against the vein or vessel wall to ensure the hooks engage the wall but not so much force as to cause injury to the wall. For example, a filter intended to be placed in a narrow vein or vessel, such as a child or dog vena cava, may have smaller dimensions so that the anchor members can deploy sufficiently to accomplish the positioning, anchoring and filtering functions, than a filter intended to be placed in a large vein or vessels, such as an adult vena cava or other vessel. In an example embodiment suitable for an adult human vena cava filter, when the filter is at the temperature of the subject and unconstrained, the longitudinal distance L<NUM> is about <NUM> (<NUM> inches); Lg is about <NUM> (<NUM> inches); L<NUM> is about <NUM> (<NUM> inches); L<NUM> is about <NUM> (<NUM> inches); d<NUM> is about <NUM> (<NUM> inches); d<NUM> is about <NUM> (<NUM> inches); d<NUM> is about <NUM> (<NUM> inches); dg is between <NUM> and <NUM> (<NUM> and <NUM> inches); L<NUM> is about <NUM> (<NUM> inches); the radius of curvature R<NUM> is about <NUM> (<NUM> inches); and the thickness t<NUM> of the anchor member is about <NUM> (<NUM> inches). Most preferably, a very small radius of curvature R<NUM> can characterize anchor joint or bend AJ2 where R<NUM> can be about <NUM> (<NUM> inches).

In situation where additional retention of the filter may be desired, an anchor member can be coupled to the locator. One arrangement is shown exemplarily in <FIG>, where a hook <NUM> can be coupled to the locator proximate the tip portion. In this arrangement, both the tip portion and hook <NUM> are configured so that the locator does not penetrate through the blood vessel wall by formation of a stop region 22a defined by both the locator tip and the hook <NUM>. Another arrangement can be by coupling or forming a hook in the same configuration as hook <NUM> for the anchor members. In yet another arrangement, shown here in <FIG>, where it may not be desirable to utilize a hook, one or more stop members <NUM> can be provided on the locator at any suitable locations. As shown in <FIG>, the stop member <NUM> is in the form of a truncated cone coupled to the locator. However, the stop member <NUM> can be of any configuration as long as the member <NUM> reduces or prevents penetration of the locator through the blood vessel wall. And in yet a further arrangement, the hook <NUM> (or hook <NUM>) can be utilized in combination with the stop member <NUM> such as for example, a hook <NUM> coupled to a first locator, a hook <NUM> coupled to a second locator, a stop member <NUM> on a third locator, a combination of hook <NUM> and stop member <NUM> on a fourth locator, a combination of hook <NUM> and stop member <NUM> on a fifth locator.

Referring to <FIG>, the hook <NUM> can be provided with a proximal hook portion 40P and a distal hook portion 40D on which a sharpened tip 40T is provided. The hook <NUM> can be formed to have a thickness t3. Where the hook <NUM> is formed from a wire having a generally circular cross-section, the thickness t3 may be generally equal to the outside diameter of the wire. In an embodiment, the hook thickness t3 is approximately <NUM> to approximately <NUM> that of the anchor thickness t2. The wire can be configured to follow a radius of curvature R2 whose center is located at longitudinal distance L11 and radial distance d9 when the filter is at the temperature of a subject, as discussed above. The tip 40T can be provided with a generally planar surface 40D whose length can be approximately equal to length h1. The tip 40T may be located over a distance h2 from a plane tangential to the curved portion <NUM>.

Referring to <FIG>, the locators <NUM> are illustrated has being bounded by a first compound surface of revolution SRI about axis A by rotating one of the locators <NUM> about axis A for <NUM> degrees. The first compound surface of revolution SRI includes a portion of a truncated hyperboloid H, first frustum F1, second frustum F2, and cylindrical surface C1. With reference to <FIG> , the anchors <NUM> are illustrated as being bounded by a second compound surface of revolution SR2 about axis A by rotating one of the anchors <NUM> about axis A for <NUM> degrees. The second compound surface of revolution SR2 defined by the anchors <NUM> includes a third, fourth and fifth frustums F3, F4, and F5, respectively.

Several design parameters are believed to achieve various advantages. The various advantages include, for example, resisting migration of the filter <NUM> once installed, greater filter volume, and better concentricity with respect to the inner wall of the blood vessel. A number of design parameters may be adjusted to effect performance and fit characteristics of the filter, including, for example, the ratio of the volume V1 defined by the first surface of revolution SRI to the volume V2 defined by the second surface of revolution SR2, which may be at least <NUM>, preferably about <NUM>, and most preferably about <NUM>. Also, approximately <NUM>% or more of the volume V<NUM> may be surrounded by the volume V<NUM>, preferably at least <NUM>% of the volume V<NUM> may be surrounded by the volume V<NUM>, and most preferably, about <NUM>% of the volume V<NUM> may be surrounded by volume V<NUM> so that the portion of volume V<NUM> that is not surrounded by volume V<NUM> (i.e., the volume of V<NUM> outside the first volume V<NUM>), shown as volume V<NUM> in <FIG>, is about <NUM> (<NUM> cubic inches). Also, it has been discovered that, in the preferred embodiments, as the cross-sectional area of the hook is increased, the filter <NUM> tends to resist dislodgement when installed in a simulated blood vessel. Similarly, when the radius of curvature R<NUM> is decreased, while keeping other parameters generally constant, the resistance to dislodgement in a simulated blood vessel is increased.

The material for the filter may be any suitable bio-compatible material such as, for example, polymer, memory polymer, memory metal, thermal memory material, metal, metal alloy, or ceramics. Preferably, the material may be Elgiloy, and most preferably Nitinol which is a thermal shape memory alloy.

The use of a shape memory material, such as Nitinol, for the locator and anchor members facilitates collapsing the filter radially inward from its normally expanded (i.e., unconstrained) configuration toward its longitudinal axis into a collapsed configuration for insertion into a body vessel. The properties of Nitinol allow the filter members to withstand enormous deformations (e.g. <NUM> times as much as stainless steel) without having any effect of the filter ability to recover to the predetermined shape. This is due to the crystal phase transitions between rigid austenite and softer martensite. This phenomenon enables the implant to be loaded into a very small diameter sheath for delivery, which significantly reduces the trauma and complications to the insertion site.

Transition between the martensitic and austenitic forms of the material can be achieved by increasing or decreasing the material deformation above and below the transition stress level while the material remains above the transition temperature range, specifically Af. This is particularly important in the case of the hooks, as they may be deformed significantly (hence, becoming martensitic) while the filter is challenged by clots. The super-elastic properties will allow the hooks to re-assume their intended shape as soon as the load is released (e.g. the clot breaks down).

The hooks may be retrieved from the Inferior Vena Cava ("IVC") wall during the filter removal when longitudinal force is applied to the hub <NUM> in the direction of the BF (i.e., towards the hub <NUM> of the filter). Under this concentrated stress, the hooks will straighten and transition to the martensitic state, thereby becoming super-elastic. Thus the hooks <NUM> are designed to bend toward a substantially straight configuration when a specific hook migration force is applied and spring back to their original shape once the hook migration force is removed.

Alternatively, a reduction in temperature below the Af temperature can be applied to the shape memory material, to cause a change in the crystalline phase of the material so as to render the material malleable during loading or retrieval of the filter. Various techniques can be used to cause a change in crystalline phase such as, for example, cold saline, low temperature fluid or thermal conductor.

By virtue of the characteristics of thermal shape memory material, the locator and anchor members can be cooled below the martensitic-to-austenitic transition temperature, and then straightened and held in a collapsed, straight form that can pass through a length of fine plastic tubing with an internal diameter of approximately <NUM> millimeters (mm), e.g., a #<NUM> French catheter. In its high temperature form (as in a mammalian body), the filter <NUM> recovers to a preformed filtering shape as illustrated by <FIG>. Alternatively, the locator and/or anchor members may be made of wires of spring metal which can be straightened and compressed within a catheter or tube and will diverge into the filter shape of <FIG> when the tube is removed.

The deployed shapes and configurations of the filter members can be set (imprinted with a memory shape) by annealing the members at high temperature (e.g. approximately <NUM>. ) while holding them in the desired shape. Thereafter, whenever the filter is in the austenitic form (i. e, at a temperature above the martensitic-to-austenitic transition temperature or Af temperature), the members return to the memory shape. Example methods for setting the high-temperature shape of filters are disclosed in <CIT>.

In the high-temperature form of the shape memory material, the filter has generally coaxial first and second filter baskets or sieves, each filter basket being generally symmetrical about the longitudinal axis of the filter with both filter baskets being concave relative to the filter leading end.

The sieve V<NUM> formed by anchor members <NUM> is the primary filter and can be up to twelve circumferentially spaced anchor members <NUM>. Six anchor members <NUM> are shown in the embodiment illustrated in the figures. The anchor members may be of equal length, but may be of different length so that the hooks <NUM> at the ends of the wires will fit within a catheter without becoming interconnected. The anchor members <NUM>, in their expanded configuration illustrated in <FIG> (i.e., unconstrained in the high temperature form), are at a slight angle to the vessel wall, preferably within a range of from ten to forty-five degrees, while the hooks <NUM> penetrate the vessel wall to anchor the filter against movement. The anchor members <NUM> are radially offset relative to the locator members <NUM> and may be positioned radially halfway between the locator members <NUM> and also may be circumferentially spaced by sixty degrees of arc as shown in <FIG>. The locator members <NUM> form sieve V<NUM>. Thus, the combined filter sieves V<NUM> and V<NUM> can provide a wire positioned radially about the hub <NUM>, such as at every thirty degrees of arc at the maximum divergence of the filter sections. With reference to the direction of blood flow BF shown by the arrow in <FIG> and <FIG>, in the illustrated embodiment, the filter section V<NUM> forms a frustum toward the hub <NUM> of the filter <NUM> while the filter section V<NUM>. forms a generally frustum-like concave sieve with its geometric center proximate the terminal end <NUM> of the hub <NUM>. In the preferred embodiments, the volume V<NUM> of the surface SRI may be between about <NUM> and about <NUM> (about <NUM> and about <NUM> cubic inches), preferably about <NUM> (<NUM> cubic inches) and the volume V<NUM> of the surface SR2 may be between about <NUM> and about <NUM> (about <NUM> and about <NUM> cubic inches), preferably about <NUM> (about <NUM> cubic inches).

The structure of the hooks <NUM> is believed to be important in resisting migration of the filter once installed while allowing for removal from the blood vessel after installation. As in the case of hooks formed on the anchor members of known permanent vena cava filters, these hooks <NUM> penetrate the vessel wall when the filter <NUM> is expanded to anchor the filter in place and prevent filter migration longitudinally within the vessel in either direction. However, when the hooks <NUM> are implanted and subsequently covered by the endothelium layer, they and the filter can be withdrawn without risk of significant injury or rupture to the vena cava. Minor injury to the vessel wall due to hook withdrawal such as damage to the endothelial layer or local vena cava wall puncture is acceptable.

To permit safe removal of the filter, the juncture section <NUM> may be considerably reduced in cross section relative to the thickness t2 or cross section of the anchor member <NUM> and the remainder of the hook <NUM>. The juncture section <NUM> can be sized such that it is of sufficient stiffness when the anchor members <NUM> are expanded to permit the hook <NUM> to penetrate the vena cava wall. However, when the hook is to be withdrawn from the vessel wall, withdrawal force in the direction of blood flow BF will cause flexure in the juncture section <NUM> so that the hook tip 40T moves toward a position parallel with the axis A (i.e., the hook straightens). With the hooks so straightened, the filter can be withdrawn without tearing the vessel wall while leaving only small punctures. In an embodiment, the anchor member <NUM> has a cross-sectional area of about <NUM><NUM> (about <NUM> squared inches), and the hook <NUM>, particularly the curved junction section <NUM> has a cross-sectional area of about <NUM> <NUM> (<NUM> squared inches).

With reference to <FIG>, it will be noted that the entire hook <NUM> can be formed with a cross section t3 throughout its length that is less than that of the locator <NUM> members (which have thickness t<NUM>) or anchor members <NUM> (which have thickness t<NUM>). As a result, an axial withdrawal force will tend to straighten the hook <NUM> over its entire length. This elasticity in the hook structure is believed to prevent the hook from tearing the vessel wall during withdrawal.

As previously indicated, while it is possible that the filter could be made from ductile metal alloys such as stainless steel, titanium, or Elgiloy, it is preferable to make it from Nitinol. Nitinol is a low modulus material that allows the locator and anchor members of the device <NUM> to be designed to have low contact forces and pressures while still achieving sufficient anchoring strength to resist migration of the device. The force required to cause opening of the hooks <NUM> can be modulated to the total force required to resist filter migration. This is accomplished by changing the cross sectional area or geometry of the hooks, or by material selection, as discussed above.

In addition to temperature sensitivity, when in the high temperature austenitic state, Nitinol is also subject to stress sensitivity that can cause the material to undergo a phase transformation from the austenitic to the martensitic state while the temperature of the material remains above the transition temperature. By reducing the cross sectional area of a portion or all of the hooks <NUM> relative to that of the anchor members <NUM> or locator members <NUM>, stress will be concentrated in the areas of reduced cross section when longitudinal force is applied to the hub <NUM> in the direction of the BF (i.e., towards the hub <NUM> of the filter) such as to remove the filter. Under this concentrated stress, the reduced cross section portions of the hooks may transition to the martensitic state, thereby becoming elastic so that they straighten. Thus the hooks <NUM>, whether formed of Nitinol, Elgiloy, spring metal or plastic, are designed to bend toward a substantially straight configuration when a specific hook migration force is applied and spring back to their original shape once the hook migration force is removed.

The force or stress that is required to deform the hooks <NUM> can be correlated to the force applied to each hook of the device when it is fully occluded and the blood pressure in the vessel is allowed to reach <NUM> millimeters of mercury (mm Hg) in a test stand. The test stand (not shown) can be configured to have a length of tubing (with various internal diameters) to allow a filter to be suitably attached thereto. The tubing is connected to another tubing having a terminal end exposed to ambient atmosphere and marked with gradations to indicate the amount of pressure differential across the filter, which is related to the force being applied to each locator of the filter <NUM>. This force is approximately at least <NUM> grams on each anchor of a six-anchor device for at least <NUM> millimeters Hg pressure differential in a <NUM> vessel. The desired total migration resistance force for the filter is believed to be approximately <NUM> grams for the embodiment of a vena cava filter for an adult human subject, and more anchor members <NUM> with hooks <NUM> can be added to lower maximum migration force for each hook. The load on the filter would be correspondingly smaller in vessels of smaller diameter. Preferably the hooks <NUM> perform as an anchoring mechanism at a predetermined filter migration resistance force within a range of about <NUM> Hg up to about <NUM>-<NUM> Hg. Having maintained its geometry at a predetermined filter migration resistance force within this range, the hook <NUM> preferably begins to deform in response to a higher force applied in the direction of the hub, i.e., the filter trailing end TE with respect to blood flow, and release at a force substantially less than that which would cause damage to the vessel tissue. It is the ability of the hook to straighten somewhat that allows for safe removal of the preferred embodiment filters from the vessel wall.

After the filter <NUM> has remained in place within a blood vessel for a period of time in excess of two weeks, the endothelium layer will grow over the hooks <NUM>. However, since these hooks <NUM>, when subjected to a withdrawal force in the direction of the hub (i.e., toward the trailing end TE) become substantially straight sections of wire oriented at a small angle to the vessel wall, the filter can be removed leaving only six pin point lesions in the surface of the endothelium. To accomplish this, a catheter such as, for example, the unit described and shown in <CIT>, or similar retrieval unit is inserted over the hub <NUM> and into engagement with the locator members <NUM>. While the hub <NUM> is held stationary, the catheter may be moved downwardly, forcing the locator members <NUM> to fold towards the axis A, and subsequently engaging the anchor members <NUM> and forcing them downwardly thereby withdrawing the hooks <NUM> from the endothelium layer. Then the hub <NUM> may be drawn into the catheter to collapse the entire filter <NUM> within the catheter. When the filter is formed from shape memory material, cooling fluid (e.g., chilled saline) may be passed through the catheter during these steps to aid in collapsing the filter.

The primary objective of the hooks <NUM> is to ensure that the filter does not migrate during normal respiratory function or in the event of a massive pulmonary embolism. Normal inferior vena cava (IVC) pressures are believed to be between about <NUM> Hg and about <NUM> Hg. An occluded IVC can potentially pressurize to <NUM> mmHg below the occlusion. To ensure filter stability, a <NUM> Hg pressure drop across the filter may therefore be chosen as the design criteria for the filter migration resistance force for the removable filter <NUM>. When a removal pressure is applied to the filter that is greater than at least <NUM> millimeters Hg, the hooks <NUM> will deform and release from the vessel wall. The pressure required to deform the hooks can be converted to force by the following calculations.

Since <NUM> Hg = <NUM> pounds per square inch (psi), <NUM> Hg = <NUM> psi.

Migration force is calculated by: <MAT> F = P×A <MAT>.

It should be noted that as the vena cava diameter increases so does the force required to resist at least <NUM> millimeters Hg of pressure. Depending on the number of filter hooks, the strength of each can be calculated. For a device that has six hooks: <MAT>.

In other words, each hook must be capable of resisting approximately at least <NUM> grams of force for the filter <NUM> to resist at least <NUM> millimeters Hg pressure gradient in a <NUM> vessel.

To prevent excessive vessel trauma each individual hook needs to be relatively weak. By balancing the number hooks and the individual hook strength, minimal vessel injury can be achieved while still maintaining the at least <NUM> millimeters Hg pressure gradient criteria, or some other predetermined pressure gradient criteria within a range of from <NUM> mmHg to <NUM> Hg.

Referring to <FIG>, the anchor members <NUM> may be angled outwardly from the anchor joint or bend AJ1 adjacent to but spaced from the outer end of each anchor member <NUM>. When the anchor members <NUM> are released from compression in a catheter or other tube into a body vessel, this bend in each anchor member insures that the hooks <NUM> are, in effect, spring loaded in the tube and that they will not cross as they are deployed from the tube. Since the anchor members <NUM> angled outwardly from the shoulders <NUM>, the hooks <NUM> are rapidly deployed outwardly as the insertion tube is withdrawn.

In an embodiment, bio-active agents can be incorporated with the blood filter, such as by way of a coating on parts of the filter, or dissolvable structures on, within or attached to the filter. Bio-active agent may be included as part of the filter in order to treat or prevent other conditions (such as infection or inflammation) associated with the filter, or to treat other conditions unrelated to the filter itself. More specifically, bio-active agents may include, but are not limited to: pharmaceutical agents, such as, for example, antiproliferative/antimitotic agents including natural products such as vinca alkaloids (i.e. vinblastine, vincristine, and vinorelbine), paclitaxel, epidipodophyllotoxins (i.e. etoposide, teniposide), antibiotics (dactinomycin (actinomycin D) daunorubicin, doxorubicin and idarubicin), anthracyclines, mitoxantrone, bleomycins, plicamycin (mithramycin) and mitomycin, enzymes (L-asparaginase which systemically metabolizes L-asparagine and deprives cells which do not have the capacity to synthesize their own asparagine); antiplatelet agents such as G(GP) IIb/IIIa inhibitors and vitronectin receptor antagonists; antiproliferative/antimitotic alkylating agents such as nitrogen mustards (mechlorethamine, cyclophosphamide and analogs, melphalan, chlorambucil), ethylenimines and methylmelamines (hexamethylmelamine and thiotepa), alkyl sulfonates-busulfan, nirtosoureas (carmustine (BCNU) and analogs, streptozocin), and trazenes-dacarbazinine (DTIC); anti-proliferative/antimitotic antimetabolites such as folic acid analogs (methotrexate), pyrimidine analogs (fluorouracil, floxuridine, and cytarabine), purine analogs and related inhibitors (mercaptopurine, thioguanine, pentostatin and <NUM>-chlorodeoxyadenosine {cladribine}); platinum coordination complexes (cisplatin, carboplatin), procarbazine, hydroxyurea, mitotane, aminoglutethimide; hormones (i.e. estrogen); anti-coagulants (heparin, synthetic heparin salts and other inhibitors of thrombin); fibrinolytic agents (such as tissue plasminogen activator, streptokinase and urokinase), aspirin, dipyridamole, ticlopidine, clopidogrel, abciximab; antimigratory agents; antisecretory agents (e.g., breveldin); antiinflammatory agents, such as adrenocortical steroids (cortisol, cortisone, fludrocortisone, prednisone, prednisolone, <NUM>. -methylprednisolone, triamcinolone, betamethasone, and dexamethasone), non-steroidal agents (salicylic acid derivatives i.e. aspirin; paraaminophenol derivatives i.e. acetominophen; indole and indene acetic acids (indomethacin, sulindac, and etodalac), heteroaryl acetic acids (tolmetin, diclofenac, and ketorolac), arylpropionic acids (ibuprofen and derivatives), anthranilic acids (mefenamic acid, and meclofenamic acid), enolic acids (piroxicam, tenoxicam, phenylbutazone, and oxyphenthatrazone), nabumetone, gold compounds (auranofin, aurothioglucose, gold sodium thiomalate); immunosuppressives: (cyclosporine, tacrolimus (FK-<NUM>), sirolimus (rapamycin), azathioprine, mycophenolate mofetil); angiogenic agents, such as vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF); angiotensin receptor blockers; nitric oxide donors; anti-sense oligionucleotides and combinations thereof; cell cycle inhibitors, such as mTOR inhibitors, and growth factor receptor signal transduction kinase inhibitors; retenoids; cyclin/CDK inhibitors; HMG co-enzyme reductase inhibitors (statins); and protease inhibitors.

A filter delivery unit (not shown) such as, for example, the unit described in <CIT>, is adapted to deliver the filter <NUM> through a catheter or delivery tube to a generally centered position within a body vessel, as described in further detail in the above mentioned patent. Preferably, the delivery system may be the delivery system shown and described in <CIT>.

In an embodiment, a radio-opaque material can be incorporated in a portion of the filter, preferably the hub <NUM> of the filter. As used herein, a radio-opaque material is any material that is identifiable to machine or human readable radiographic equipment while the material is inside a mammal body, such as, by way of example but not by way of limitation, gold, tungsten, platinum, barium sulfate, or tantalum. The use of a radio-opaque material in the filter permits the clinician to locate the filter within a blood vessel of the subject using radiographic equipment. Radio-opaque material may be in the form of an additional structure added to the hub, such as a cap, sleeve, shim, wire or braze included around or in the hub assembly. Alternatively, the hub itself may be formed of a radio-opaque alloy.

Instead of a hub <NUM>, as in the above described examples, a retrieving hook can be provided as part of filter device <NUM>, as in the embodiment shown in <FIG>. The filter device <NUM> includes a hub <NUM> with a retrieving hook <NUM>. The hook <NUM> is configured for use by a snaring device to retrieve the filter <NUM> from a subject. Referring to <FIG> and <FIG>, the retrieving hook <NUM> can be formed as a monolithic member <NUM> with the hub <NUM> or as a separate member joined to the hub <NUM> by a suitable technique, such as, for example, EDM, laser welding, plasma welding, welding brazing, welding, soldering, or bonding. In a preferred embodiment, the member <NUM> can be a machined billet member with a blind bore <NUM> formed through a portion of the hub <NUM>. The hook portion <NUM> includes ramped surfaces <NUM> and <NUM> that are believed to be advantageous in allowing the filter <NUM> to be retrieved without binding at the catheter opening due to an offset entry position of the filter <NUM>. In other words, there may be circumstances during removal procedures where the axis <NUM> of the member <NUM> is not generally parallel or aligned with a longitudinal axis of the catheter retrieving device. In such cases, the greater the retention force, it is believed that the greater the likelihood of the hook being snagged on the catheter inlet opening thereby complicating the filter retrieval process. By virtue of the ramps <NUM> and <NUM>, it is believed that binding or snagging is substantially reduced. In particular, as shown in <FIG> and <FIG>, the ramp <NUM> includes a radius of curvature R4 coupled to flat portions <NUM> and <NUM>. The flat portion <NUM> can be coupled to a hook portion <NUM> which has a radiused surface R6. As shown in <FIG>, the flat portion <NUM> is coupled to another radiused portion R7. It should be noted that the drawings provided herein are to scale relative to every part illustrated in each drawing.

A range of values may be used for the aforementioned dimensional parameters in order to provide a retrieval hook <NUM> that is capable of retaining portions of the locator and anchor members <NUM> and <NUM> within blind hole <NUM>. For example, a smaller filter may have smaller dimensions so that the retrieval hook <NUM> does not present undue blockage in the vein, than a filter intended to be placed in a large vein or vessels, such as an adult vena cava or other vessel. Further, the retrieval hook <NUM> may be made from or include a radio-opaque material to allow a clinician to locate the hook within a subject using radiographic equipment, such as to aid in engaging the hook with a retrieval mechanism.

In an embodiment of the invention illustrated in <FIG>, a filter <NUM> is laser cut from a metal tube and includes a hub <NUM>, locator member <NUM>, and anchor member <NUM>. The locator member <NUM> includes a proximal locator end 320P and a distal locator end 320D, similar to locator member <NUM> of <FIG>. Likewise, the anchor member <NUM> includes a proximal anchor end 330P and a distal anchor end 330D. The distal anchor end 330D of each anchor member <NUM> includes an extension member. In the illustrated embodiment, four of the six anchor members include a cranial extension <NUM> and two of the six anchor members include a caudal extension <NUM>. In other embodiments, the extension members can be distributed differently. For example, the number of anchor members with cranial extension <NUM> can be less than or more than four, and the number of anchor members with caudal extension <NUM> can be one, three, or more. Both the cranial extension <NUM> and caudal extension <NUM> bifurcate into a penetration member and a penetration limiter. The penetration member is designed to penetrate the vessel wall while the penetration limiter is designed to limit the penetration of the penetration member.

<FIG> shows a close-up view of the cranial extension <NUM> from <FIG>. In an example embodiment suitable for an adult human vena cava filter, when the filter is at the temperature of the subject and unconstrained, the radius of curvature R<NUM> is about <NUM> (<NUM> inches); the length h<NUM> is about <NUM> (<NUM> inches); the length h<NUM> is about <NUM> (<NUM> inches); the length h<NUM> is about <NUM> (<NUM> inches); the length h<NUM> is about <NUM> (<NUM> inches); the angle θ<NUM> is about <NUM> degrees; the angle θ<NUM> is about <NUM> degrees. It should be noted that the values given herein are approximate, representing a dimension within a range of suitable dimensions for the particular embodiment illustrated in the figures, and that any suitable values can be used as long as the values allow the filter to function as intended in a blood vessel of a subject. The geometry and bending of the cranial hook <NUM> will facilitate removal from the vessel, although it should be noted that the bending may be of various degrees less than substantially straight. Referring to the pressure required to deform the cranial hook <NUM> using the calculations above, because the number of cranial hooks <NUM> in filter <NUM> numbers four, the required hook strength is about <NUM> grams (<NUM>/<NUM>), meaning that each hook must be minimally capable of resisting approximately <NUM> grams of force for the filter <NUM> to resist at least <NUM> millimeters IIg pressure gradient in a <NUM> vessel.

A depiction of an exemplary cranial extension is illustrated in <FIG>. The cranial extension <NUM>' bifurcates from a base <NUM>' into a cranial hook <NUM>' and a cranial limiter <NUM>'. The base <NUM>' has a width that is greater than the anchor member <NUM>' from which it extends in the embodiment shown to provide a greater width to both the cranial hook <NUM>' and cranial limiter <NUM>', and also to assist the cranial limiter <NUM>' in limiting penetration of the cranial hook <NUM>'. In the embodiment shown in <FIG>, both the cranial hook <NUM>' and cranial limiter <NUM>' have a tapered portion extending from the base bifurcation, but such tapered portion is optional. The cranial hook <NUM>' prevents cranial movement of the filter toward the heart following deployment and is configured in one embodiment with the design and characteristics of hook <NUM> as illustrated in <FIG> and described herein. The cranial hook <NUM>' may have a reduced thickness relative to the anchor member <NUM>', which is formed through local modification prior to or after filter forming to achieve desired stiffness. For example, when formed from a tube, the flexibility of the cranial hook <NUM>' can be fine-tuned by locally removing material from the inner or outer surface of the tube at the position of the hook <NUM>'. As discussed above in connection with hook <NUM>, the cranial hook <NUM>' can be configured to bend toward a substantially straight configuration when a specific hook migration force is applied, and spring back to an original shape once the hook migration force is removed.

<FIG> shows the cranial extension <NUM>' deployed in a body vessel with the cranial hook <NUM>' penetrating a vessel wall <NUM> and the cranial limiter <NUM>' contacting the vessel wall <NUM> to prevent excessive penetration of the cranial hook <NUM>'. The configuration of the cranial extension <NUM>' (e.g., through the base width, limiter length, hook flexibility, etc.) limits the penetration distance of the cranial hook <NUM>' while preventing cranial movement. The cranial limiter <NUM>' is formed with a non-penetrating distal end to prevent penetration of the vessel wall <NUM>. However, in some embodiments, the cranial limiter <NUM>' may act as, and/or be configured for, prevention of caudal movement. In the illustrated embodiment, the cranial limiter <NUM>' is essentially straight with respect to the anchor member <NUM>'; however, in other embodiments, the cranial limiter can be curved or angled. The cranial limiter may also include a widened distal end in the form of a tab as shown and discussed in connection with the caudal limiter below.

<FIG> shows a close-up view of the caudal extension <NUM> from <FIG>. In an example embodiment suitable for an adult human vena cava filter, when the filter is at the temperature of the subject and unconstrained, the radius of curvature R<NUM> is about <NUM> (<NUM> inches); the length h<NUM> is about <NUM> (<NUM> inches); the length h<NUM> is about <NUM> (<NUM> inches); the length h<NUM> is about <NUM> (<NUM> inches). It should be noted that the values given herein are approximate, representing a dimension within a range of suitable dimensions for the particular embodiment illustrated in the figures, and that any suitable values can be used as long as the values allow the filter to function as intended in a blood vessel of a subject.

A depiction of an exemplary caudal extension is illustrated in <FIG>. The caudal extension <NUM>' bifurcates from a base <NUM>' into a caudal anchor <NUM>' and a caudal limiter <NUM>'. The base <NUM>' has a width that is greater than the anchor member <NUM>' from which it extends in the embodiment shown to provide a greater width to both the caudal anchor <NUM>' and caudal limiter <NUM>', and also to assist the caudal limiter <NUM>' in limiting penetration of the caudal anchor <NUM>'. In the embodiment shown in <FIG>, both the caudal anchor <NUM>' and caudal limiter <NUM>' extend from the base bifurcation with a constant width. However, in other embodiments, both may include a tapered portion similar to that of the cranial extension <NUM>', The caudal anchor <NUM>' prevents caudal movement of the filter away from the heart following deployment and is configured with a distal blade configured to penetrate the vessel. The caudal anchor <NUM>' may have a reduced thickness relative to the anchor member <NUM>', which is formed through local modification prior to or after filter forming to achieve desired stiffness. For example, when formed from a tube, the flexibility of the caudal anchor <NUM>' can be fine-tuned by locally removing material from the inner surface of the tube at the position of the anchor <NUM>'.

<FIG> shows the caudal extension <NUM>' deployed in a body vessel with the caudal anchor <NUM>' penetrating a vessel wall <NUM> and the caudal limiter <NUM>' contacting the vessel wall <NUM> to prevent excessive penetration of the caudal anchor <NUM>'. The configuration of the caudal extension <NUM>' (e.g., through the base width, limiter length, etc.) limits the penetration distance of the caudal anchor <NUM>' while preventing caudal movement. The caudal limiter <NUM>' is formed with a non-penetrating distal end to prevent penetration of the vessel wall <NUM>, In the illustrated embodiment, the caudal limiter <NUM>' is curved with respect to the anchor member <NUM>'; however, in other embodiments, the caudal limiter can be straight or angled. The caudal limiter may have a length greater than the caudal anchor, as shown in <FIG>. Alternatively, the caudal limiter may be the same length or shorter than the caudal anchor. The caudal limiter may also include a widened distal end in the form of a tab <NUM> as best seen in <FIG>.

In one embodiment, in addition to cranial extensions and caudal extensions, the anchor members include an extension having a base that bifurcates into a cranial hook and caudal anchor.

Referring again to <FIG>, the filter <NUM> includes six locator members <NUM> and six anchor members <NUM> extending from the hub <NUM> and disposed along a longitudinal axis of the filter <NUM>. The locator members <NUM> are alternatingly interposed between the anchor members <NUM> such that each locator member <NUM> extends from the hub between adjacent pairs of anchor members, and vice versa. However, in other embodiments, the locator members <NUM> and/or anchor members <NUM> may be directly adjacent to one another without an intervening anchor member <NUM> and/or locator member <NUM>. Each of the locator members <NUM> have essentially the same size and configuration, and include four segments LS1, LS2, LS3, and LS4, as described in more detail below in connection with <FIG>. While the locator members in the illustrated embodiment do not include hooks or anchors, in other embodiments one or more locator members may include an extension, a hook and/or an anchor as described herein. The total anchor members and locator members in other embodiments can be more or less than the <NUM> shown in the illustrated embodiment.

In <FIG>, the six anchor members <NUM> have three different lengths measured from the hub <NUM> along the longitudinal axis of the filter, a first length/distance from the hub <NUM> is the shortest (i.e., L10A in <FIG>), a second length/distance from the hub <NUM> is greater than the first length/distance (i.e., L10B in <FIG>), , and the third length/distance from the hub <NUM> is greater than both the first and second lengths/distances (i.e., L10C in <FIG>). In other embodiments, the anchor members may have two different lengths or four or more different lengths. In embodiments in which the anchor members include cranial extensions, caudal extensions, cranial hooks, caudal anchors, or other forms of hooks or anchors, providing different anchor member lengths in a staggered pattern facilitates collapse into a filter constrained or delivery configuration, and also potentially reduces the necessary components of a delivery system (e. g, because the hooks and anchors are staggered and positioned in a compact manner as discussed below with respect to the method of folding, it is possible to deliver the filter without the use of a means of holding or covering the hooks in the delivery sheath). The anchor members <NUM> have an essentially straight configuration distal of the proximal anchor end 330P, which curves outward from the filter longitudinal axis in the filter expanded configuration. In other configurations, the anchor members <NUM> may have one or more segments extending along different axes, similar to anchor members <NUM> discussed above in connection with <FIG> and <FIG>.

Of the six anchor members <NUM>, two anchor members extend the first distance from the hub <NUM>, two anchor members extend the second distance from the hub <NUM>, and two anchor members extend the third distance from the hub <NUM>. The pair of first length anchor members and the pair of second length anchor members each include cranial extensions at a distal end thereof. The difference between the first length and second length in one embodiment is measured from the tips of the cranial hooks <NUM> in a filter expanded (unconstrained) configuration, i.e., L<NUM> as shown in <FIG>. In the embodiment shown in <FIG>, L<NUM> is approximately <NUM> (<NUM> inches). The pair of third length anchor members each include caudal extensions at a distal end thereof. The combination of anchor members with cranial extensions and caudal extensions prevent both caudal and cranial movement of the blood filter, thereby stabilizing the filter in the deployed position inside of a body vessel.

In the illustrated embodiment of <FIG>, the pairs of first, second and third length anchor members are positioned opposite from one another about the hub (i.e., <NUM> degrees). From a top view of the filter in an expanded configuration (e.g., see <FIG>), using a clock analogy, the pair of anchor members are positioned as follows: when the first length anchor members are positioned at <NUM> and <NUM>, the pair of second length anchor members are positioned at <NUM> and <NUM>, and the pair of third length anchor members are positioned at <NUM> and <NUM>. As described in detail below, this particular respective positioning of the anchor members facilitates the preparation of the filter for loading and delivery. Other possibilities with respect to anchor member positioning with respect to the hub may alternatively be desired, and therefore it should be appreciated that the illustrated embodiment is not intended to be limiting.

As shown in <FIG>, the locator member <NUM> is similar in many respects to the locator member <NUM>, including the plurality of locator segments LS1-LS4, However, the locator member <NUM> has the following dimensional parameters which may differ slightly from the locator member <NUM> described above. In an example embodiment suitable for an adult human vena cava filter, when the filter is at the temperature of the subject and unconstrained, the radius of curvature R<NUM> is about <NUM> (<NUM> inches); the length L<NUM> is about <NUM> (<NUM> inches); length L<NUM> is about <NUM> (<NUM> inches); distance d<NUM> is about <NUM> (<NUM> inches); distance d<NUM> is about <NUM> (<NUM> inches), the first angle θ<NUM> is about <NUM> degrees, the second angle θ<NUM> is about <NUM> degrees; and the thickness t<NUM> of the locator member <NUM> along section LS<NUM> is about <NUM> (<NUM> inches), and along LS<NUM> is also about <NUM> (<NUM> inches). The longitudinal distance L10A is about <NUM> (<NUM> inches), L10B is about <NUM> (<NUM> inches), L10C is about <NUM> (<NUM> inches), and L<NUM> is about <NUM> (<NUM> inches); d<NUM> is about <NUM> (<NUM> inches); the radius of curvature R<NUM> is about <NUM> (<NUM> inches); and the thickness t<NUM> of the anchor member is about <NUM> (<NUM> inches). It should be noted that the values given herein are approximate, representing a dimension within a range of suitable dimensions for the particular embodiment illustrated in the figures, and that any suitable values can be used as long as the values allow the filter to function as intended in a blood vessel of a subject.

It should also be noted that although the thickness of the locator member <NUM> and anchor member <NUM> is described in an exemplary embodiment as being uniform throughout their lengths (e.g., having the same thickness as the rest of the filter <NUM>), other embodiments include varying thicknesses along the length of the locator member. For example, the locator member and/or anchor member may include segments with different thicknesses or have varying thicknesses along select segments. It is also noted that the widths of the locator member and/or anchor members could similarly vary along their lengths. For example, in one embodiment the width of locator segment LS1 is greater than the other locator segments which have a uniform width. Further, while the anchor members <NUM> of filter <NUM> are wider than the locator members <NUM>, in other embodiments, the anchor members and locator members may be the same width, or the locator members may be wider than the anchor members.

As described herein, the filter <NUM> is cut from a metal tube (e.g., Nitinol). The formation of filter <NUM> from a tube provides the opportunity to locally reduce thicknesses of sections of the filter, such as the cranial hook <NUM> and/or the caudal anchor <NUM>. Following the laser cutting of the tube and forming of the filter, electropolishing, chemical etching or other similar processes can be utilized to enhance the surface finish for improved corrosion resistance and a fatigue life. It is also noted that filter <NUM> could be formed from wires or sheet.

The filter hub <NUM> can include a retrieval member <NUM> as shown in <FIG>. The retrieval member <NUM> can be formed from a solid rod with an extension <NUM> that can be inserted into the open end of the hub <NUM>, as shown in <FIG> , and then welded, crimped or otherwise permanently attached to the hub <NUM>. Alternatively, the retrieval member <NUM> can be formed directly from the tube from which the filter is formed as shown in <FIG> is a side view of the retrieval member <NUM> and <FIG> is a front view of the retrieval member <NUM>. As can be seen in <FIG>, any number of patterns and formations can be cut from the tube to enhance the retrievability of the filter <NUM>.

An exemplary method of preparing the filter <NUM> for loading and delivery is shown in <FIG>. The positioning of the anchor members <NUM> in relation to each other and the other filter features facilitates collapsing the filter <NUM> into a low profile, in part due to the staggered lengths of the anchor members <NUM>. The filter <NUM> includes six anchor members and six locator members, which for reference are numbered successively counterclockwise about the circumference of the hub <NUM> when viewed from the anchor member distal ends as first, second, third, fourth, fifth, and sixth anchor members, and first, second, third, fourth, fifth, and sixth locator members, where the first locator member is positioned closest clockwise of the first anchor member (i.e., extending between the first anchor member and sixth anchor member). It should be appreciated that the method shown and described is only one example and many variations are possible. For example, while the third segment LS<NUM> of the locator member is described as being positioned behind the anchor member, any length of a locator member or its equivalent component in a blood filter could be so positioned. Further, the positioning order could be varied, as could the positioning of the locator members relative to one another. Further still, rather than positioning a length of locator members behind two anchor members, the length of locator members could be positioned behind one, three, or more anchor members.

<FIG> shows the filter <NUM> with the anchor members constrained in a collapsed configuration by a tube <NUM>; however other constraining methods and/or devices are also possible. The tube <NUM> is slid over the hub <NUM> toward the anchor member distal ends 330D until the distal end of the tube abuts the cranial hooks on the first length anchor members. The locator members <NUM> are removed from the tube (if the tube initially covers the ends thereof) so that they are in an expanded configuration as shown in <FIG>. As shown in <FIG>, the third locator segment LS<NUM> of the first locator member <NUM><NUM> is positioned behind (i.e., toward the filter longitudinal axis) the first anchor member <NUM><NUM> and the second anchor member <NUM><NUM> such that a distal end of the first locator member <NUM>, extends between the second anchor member <NUM><NUM> and the third anchor member <NUM><NUM>. As shown in <FIG>, the third locator segment LS<NUM> of the second locator member <NUM><NUM> is then positioned behind the second anchor member <NUM><NUM> and the third anchor member <NUM><NUM> such that a distal end of the second locator member <NUM><NUM> extends between the third anchor member <NUM><NUM> and the fourth anchor member <NUM><NUM>.

The third locator segment LS<NUM> of the third locator member <NUM><NUM> is then positioned behind the third anchor member <NUM><NUM> and the fourth anchor member <NUM><NUM> such that a distal end of the third locator member <NUM><NUM> extends between the fourth anchor member <NUM><NUM> and the fifth anchor member <NUM><NUM>. The third locator segment LS<NUM> of the fourth locator member <NUM><NUM> is then positioned behind the fourth anchor member <NUM><NUM> and the fifth anchor member <NUM><NUM> such that a distal end of the fourth locator member <NUM><NUM> extends between the fifth anchor member <NUM><NUM> and the sixth anchor member <NUM><NUM>. The third locator segment LS<NUM> of the fifth locator member <NUM><NUM> is then positioned behind the fifth anchor member <NUM><NUM> and the sixth anchor member <NUM><NUM> such that a distal end of the fifth locator member <NUM><NUM> extends between the sixth anchor member <NUM><NUM> and the first anchor member <NUM><NUM>. Lastly, the third locator segment LS<NUM> of the sixth locator member <NUM><NUM> is positioned behind the sixth anchor member <NUM><NUM> and the first anchor member <NUM><NUM> such that a distal end of the sixth locator member <NUM><NUM> extends between the first anchor member <NUM><NUM> and the second anchor member <NUM><NUM>.

In this particular embodiment, in addition to being positioned behind two anchor members, the locator members are positioned such that, when viewed from the distal end of the anchor members 330D, each locator member is under (i.e., crosses under) its previous in number locator member (e.g., the second locator member is positioned under the first locator member). Such a positioning configuration is shown in <FIG>, which is simplified to show schematically the relative locator member positioning (e.g., only a representative length of the locator member positioned behind the anchor members is shown). In other embodiments, some of the locator members may instead be positioned over adjacent locator members.

Once the locator members <NUM> are threaded into position, the filter is partially pulled into a delivery sheath or staging sheath <NUM> as shown in <FIG>. The positioning of the anchor member extensions is verified to ensure that the anchor members with caudal extensions are surrounded by the anchor members with cranial extensions. In one embodiment, the caudal extensions are positioned such that the caudal limiters are adjacent to each other so that the flat surfaces are together to avoid catching of the caudal anchors upon deployment of the filter. The anchor member positioning is then reviewed to ensure that the cranial hooks are all facing in one direction (e.g., clockwise). In order to position the cranial hooks, for example if the cranial hooks are facing away from the longitudinal axis or in different directions, the filter is twisted as it is pulled into the delivery sheath. The cranial hooks will follow the path of least resistance and will continue twisting until they are circumferentially oriented. In one embodiment, the cranial extensions are oriented such that the cranial hooks lie against the sheath inner wall and the cranial limiters lie away from the sheath inner wall for beneficial distribution of the available volume. Once properly oriented, the filter is completely pulled into the delivery sheath.

Claim 1:
A filter (<NUM>) to be placed in a flow of blood through a vessel, comprising:
a hub (<NUM>) disposed along a longitudinal axis;
a plurality of anchor members (<NUM>, <NUM>') extending from the hub, at least one anchor member distal end (330D) spaced from the hub at each of a first (L10A), second (L10B), and third distance (L10C) along the longitudinal axis; and
a plurality of locator members (<NUM>), each locator member extending from the hub between an adjacent pair of anchor members; each anchor member includes either a cranial extension (<NUM>) or a caudal extension (<NUM>, <NUM>') at a distal end (330D) thereof, and characterized in that:
the cranial extensions (<NUM>, <NUM>') include a cranial hook (<NUM>, <NUM>') and a cranial limiter (<NUM>, <NUM>') extending separately from a cranial base (<NUM>) having a width greater than a width of the anchor member, and
the caudal extensions (<NUM>) include a caudal anchor (<NUM>) and a caudal limiter (<NUM>) extending separately from a caudal base (<NUM>) having a width greater than a width of the anchor member (<NUM>).