AU2017204628B2 - Embolic filter frame having looped support strut elements - Google Patents

Abstract

An embolic filter, comprising: a frame having multiple looped support struts, a deployed length and an unconstrained diameter, wherein the frame deployed length divided by 5 the frame unconstrained diameter is between about 0.5 to about 1. 9252000_1 (GHMatters) P56564.AU.4 34 3 32 FIG. 2

Description

EMBOLIC FILTER FRAME HAVING LOOPED SUPPORT STRUT ELEMENTS

RELATED APPLICATION

This application is a divisional application of Australian patent application no.

2015201038, which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The invention relates to embolic filter devices for placement in the vasculature and in particular, self-expanding frames used to support embolic filter elements.

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BACKGROUND OF THE INVENTION

Embolic protection is a concept of growing clinical importance directed at reducing the risk of embolic complications associated with interventional (i.e., transcatheter) and surgical procedures. In therapeutic vascular procedures, liberation of embolic debris (e.g., thrombus, clot, atheromatous plaque, etc.) can obstruct perfusion of the downstream vasculature, resulting in cellular ischemia and/or death. The therapeutic vascular procedures most commonly associated with adverse embolic complications include: carotid angioplasty with or without adjunctive stent placement; and revascularization of degenerated saphenous vein grafts. Additionally, o percutaneous transluminal coronary angioplasty (PTCA) with or without adjunctive stent placement, surgical coronary artery bypass grafting, percutaneous renal artery revascularization, and endovascular aortic aneurysm repair have also been associated with complications attributable to atheromatous embolization. The use of embolic protection devices to capture and remove embolic debris, consequently, may improve patient outcomes by reducing the incidence of embolic complications.

Embolic protection devices typically act as an intervening barrier between the source of the clot or plaque and the downstream vasculature. Numerous devices and methods of embolic protection have been used adjunctively with percutaneous interventional procedures. These techniques, although varied, have a number of desirable features including: intraluminal delivery; flexibility; trackability; small delivery profile to allow crossing of stenotic lesions; dimensional compatibility with conventional interventional implements; ability to minimize flow perturbations; thromboresistance; conform ability of the barrier to the entire luminal cross section (even if irregular); and a means of safely removing the embolic protection device and trapped particulates.

There are two general strategies for achieving embolic protection: techniques that employ occlusion balloons; and techniques that employ an embolic filter. The use of embolic filters is a desirable means of achieving embolic protection because they allow continuous perfusion of the vasculature downstream to the device.

Occlusion balloon techniques have been taught by the prior art and involve

2017204628 03 Jul 2019 devices in which blood flow to the vasculature distal to the lesion is blocked by the inflation of an occlusive balloon positioned downstream to the site of intervention. Following therapy, the intraluminal compartment between the lesion site and the occlusion balloon is aspirated to evacuate any thrombus or atheromatous debris that may have been liberated during the interventional procedure. The principle drawback of occlusion balloon techniques stems from the fact that during actuation, distal blood flow is completely inhibited, which can result in ischemic pain, distal stasis/thrombosis, and difficulties with fluoroscopic visualization due to contrast wash-out through the treated vascular segment.

io A prior system described in US Patent 4,723,549 to Wholey, et al. combines a therapeutic catheter (e.g., angioplasty balloon) and integral distal embolic filter. By incorporating a porous filter or embolus barrier at the distal end of a catheter, such as an angioplasty balloon catheter, particulates dislodged during an interventional procedure can be trapped and removed by same therapeutic device responsible for the embolization. One known device includes a collapsible filter device positioned distal to a dilating balloon on the end of the balloon catheter. The filter comprises a plurality of resilient ribs secured to circumference of the catheter that extend axially toward the dilating balloon. Filter material is secured to and between the ribs. The filter deploys as a filter balloon is inflated to form a cup-shaped trap. The filter, however, does not

0 necessarily seal around the interior vessel wall. Thus, particles can pass between the filter and the vessel wall. The device also lacks longitudinal compliance. Thus, inadvertent movement of the catheter results in longitudinal translation of the filter, which can cause damage to the vessel wall and liberate embolic debris.

Other prior systems combine a guide wire and an embolic filter. The embolic filters are incorporated directly into the distal end of a guide wire system for intravascular blood filtration. Given the current trends in both surgical and interventional practice, these devices are potentially the most versatile in their potential applications. These systems are typified by a filter frame that is attached to a guide wire that mechanically supports a porous filter element. The filter frame may include radially oriented struts, one or more circular hoops, or a pre-shaped basket configuration that deploys in the vessel. The filter element is typically comprised of a polymeric or metallic mesh net, which is attached to the filter frame and/or guide wire. In operation, blood flowing through the vessel is forced through the mesh filter element thereby capturing embolic material in the filter.

Early devices of this type are described in the art, for example in US Patent

5,695,519 to Summers, et al., and include a removable intravascular filter mounted on a hollow guide wire for entrapping and retaining emboli. The filter is deployable by manipulation of an actuating wire that extends from the filter into and through the hollow tube and out the proximal end. During positioning within a vessel, the filter

2017204628 03 Jul 2019 material is not fully constrained so that, as the device is positioned through and past a clot, the filter material can potentially snag clot material creating freely floating emboli prior to deployment. The device also lacks longitudinal compliance.

Another example of a prior device, taught in US Patent 5,814,064 to Daniel, et al., uses an emboli capture device mounted on the distal end of a guide wire. The filter material is coupled to a distal portion of the guide wire and is expanded across the lumen of a vessel by a fluid activated expandable member in communication with a lumen running the length of the guide wire. During positioning, as the device is passed through and beyond the clot, filter material may interact with the clot to produce emboli, io The device also lacks longitudinal compliance.

Another device, taught in US Patent 6,152,946 to Broome, et al., which is adapted for deployment in a body vessel for collecting floating debris and emboli in a filter, includes a collapsible proximally tapered frame to support the filter between a collapsed insertion profile and an expanded deployment profile. The tapered collapsible frame includes a mouth that is sized to extend to the walls of the body vessel in the expanded deployed profile and substantially longitudinal struts that attach and tether the filter frame to the support wire. This device also lacks substantial longitudinal compliance. This device has the additional drawback of having an extended length due to the longitudinally oriented strut configuration of the tapered

0 frame. This extended length complicates the navigation and placement of the filter within tortuous anatomy.

A further example of an embolic filter system, found in PCT WO 98/33443, involves a filter material fixed to cables or spines of a central guide wire. A movable core or fibers inside the guide wire can be utilized to transition the cables or spines 25 from approximately parallel to the guide wire to approximately perpendicular the guide wire. The filter, however, may not seal around the interior vessel wall. Thus, particles can pass between the filter and the entire vessel wall. This umbrella-type device is shallow when deployed so that, as it is being closed for removal, particles have the potential to escape.

In summary, disadvantages associated with predicate devices include lack of longitudinal compliance, extended deployed length of the frame and associated tethering elements, and inadequate apposition and sealing against a vessel wall. Without longitudinal compliance, inadvertent movement of the filter catheter or support wire can displace the deployed filter and damage a vessel wall and/or introgenic vascular trauma, or, in extreme cases, result in the liberation of embolic debris. An extended deployed length aggravates proper filter deployment adjacent to vascular side branches or within tightly curved vessels. Inadequate filter apposition and sealing against a vessel wall has the undesirable effect of allowing emboli passage.

To ensure filter apposition and sealing against a vessel wall, without inducing

2017204628 03 Jul 2019 undue vascular trauma, the radial force exerted by the filter against the vessel wall should be optimized. Typical methods used to increase the radial force exerted by the filter include, for example, increasing the cross-sectional area (moment of inertia and therefore the stiffness) of the filter support frame and in particular the tethering elements of the frame. Enhanced radial force can also be achieved by incorporating additional support members or by enlarging the “relaxed” or deployed diameter of the filter frame relative to the diameter of the vessel into which it is deployed. These methods typically have the undesirable side effects of degrading the longitudinal compliance, adding to the compressed delivery profile, and, in some cases, increasing io the deployed length. Some methods used to increase the radial force (for example, stiffer support frames) have the additional drawback of requiring thicker-walled, larger profile, delivery catheters. To accommodate the increased pressure exerted by the stiff frame (constrained within the delivery catheter) a commensurately thicker catheter wall is required, compromising the delivery profile.

SUMMARY OF INVENTION

An embodiment of the present invention relates to a medical device comprising: a frame that is compressible and has a longitudinal axis, a periphery located around and orthogonal to the longitudinal axis, a proximal end defining a plane, and a distal end, the frame including a plurality of support struts extending from the periphery toward the longitudinal axis of the frame, each of support struts having a curved shape and each of the support struts being generally coplanar with one another such that each of the support struts has the curved shape when viewed along the longitudinal axis and an essentially linear shape when viewed from a side; and a membrane coupled to the frame.

An embodiment of the present invention relates to a medical device comprising: a frame having a longitudinal axis and including a collar, a plurality of curved support struts, and a support portion radially offset from the collar and having a proximal end 2 0 and a distal end, the plurality of support struts extending from the proximal end of the support portion to the collar such that the collar is longitudinally aligned with the proximal end of the support portion and such that each of the support struts is coplanar with one another and has a curved shape when viewed along the longitudinal axis and an essentially linear shape when viewed from a side; and a membrane coupled to the 25 frame.

An embodiment of the present invention relates to a method of making a

2017204628 03 Jul 2019 medical device, comprising: providing a cylindrical tube; providing a membrane; cutting the cylindrical tube to form a frame that includes: a collar that is adapted to be coupled to a support wire; a support portion; and multiple support struts, each of which extends from the support portion to the collar; and attaching the membrane to the support portion.

An embodiment of the present invention relates to a medical device, comprising: a membrane; and a frame that includes: a collar that is adapted to be coupled to a support wire; a support portion, wherein at least a portion of the support portion is attached to the membrane; and multiple support struts, each of which extends from the support portion to the collar; wherein the collar, the support portion, and the multiple support struts are formed from a single cylindrical tube of material.

Also described herein, according to a further embodiment of the invention, is an embolic filter comprising: a movable support wire having a maximum total displacement; and a frame having multiple looped support struts and an unconstrained diameter, wherein a ratio of the frame unconstrained diameter divided by the support io wire total displacement is greater than about 2.

According to a still further embodiment described herein there is provided an embolic filter, comprising: a frame having multiple looped support struts, a constrained delivery length and an unconstrained length,wherein the frame constrained delivery length divided by the unconstrained frame length is between about 2 to about 3.

In the embolic filter, at least one support strut preferably projects a looped configuration in two orthogonal views.

Another embodiment described herein is provided with an endoluminal filter assembly, comprising: a filter element; a support wire; and a filter frame comprising at least two “s” shaped support struts attaching the filter element to the support wire,

0 wherein the “s” shaped support struts are along an unattached portion of the strut. In some embodiments, the filter frame may be slidably attached to the support wire.

BRIEF DESCRIPTION OF THE DRAWINGS

The operation of the present invention should become apparent from the

5 following description when considered in conjunction with the accompanying drawings, in which:

Figure 1 is a three-quarter isometric view of an embolic filter of the present invention, with a support frame having three looped struts.

Figure 2 is an enlarged partial view of the support frame of Figure 1.

Figure 3A is an end view of the embolic filter of Figure 1, depicting the support

2017204628 03 Jul 2019 frame assuming an unconstrained diameter.

Figure 3B is a partial side-view of a looped support strut of the present invention, defining a bend angle in the support strut.

Figure 3C is a partial side-view of a looped support strut of the present invention, defining an “s” shape in the support strut.

Figure 4 is a three-quarter isometric view of an embolic filter of the present invention as deployed into a vessel.

Figure 5A is a partial three-quarter isometric view of an embolic filter of the present invention, defining the filter opening planes.

io Figures 5B through 5D are side views of an embolic filter of the present invention illustrating deployed diameters and various types of offset strut attachment points.

Figures 6A and 6B are side views of an embolic filter of the present invention defining deployed diameters and overall lengths.

Figures 6C and 6D are side views of an embolic filter frame of the present invention, defining deployed diameters and lengths.

Figures 7A through 7C are side views of an embolic filter of the present invention, showing various stages of tensioning and elongation.

Figure 7D is a side view of an embolic filter of the present invention constrained 2 0 within a sheath.

Figures 8A and 8B are, respectively, an end view and a side view of one embodiment of an embolic filter of the present invention, showing three support struts with loops, as viewed along two orthogonal axes.

Figures 9A and 9B are, respectively, an end view and a side view of a further

5 embodiment of an embolic filter of the present invention, showing three support struts with loops, as viewed along two orthogonal axes.

Figures 10A and 10B are, respectively, an end view and a side view of another embodiment of an embolic filter of the present invention, showing three support struts with loops, as viewed along two orthogonal axes.

Figures 11A and 11B are, respectively, an end view and a side view of still another embodiment of an embolic filter of the present invention, showing three support struts with loops, as viewed along two orthogonal axes.

Figures 12A through 12F are end views of embolic filters embodiments of the present invention, showing, respectively, three, four, five, six, seven, and eight looped 35 support struts.

Figure 13 is a longitudinal cross-section view of an embolic filter frame of the present invention, depicting an enhanced radial force caused by vessel wall

2017204628 03 Jul 2019 compression.

Figure 14 is a side view of an embolic filter device of the present invention wherein the frame includes a truncated filter membrane support portion.

Figure 15 is a three-quarter isometric view of a cut-out precursor tube used to fabricate a six-strut embolic filter frame of the present invention according to Example 1.

Figure 16 is a three-quarter isometric view of the precursor tube of Figure 15 that has been expanded to form a six-strut embolic filter frame of the present invention.

Figure 17 is a side view of an expanded and inverted precursor tube used to io fabricate a six-strut embolic filter frame of the present invention according to Example 1.

Figures 18A through 18C are longitudinal cross-section views of another embodiment of an embolic filter device of the present invention having a slidable attachment between the filter frame and the support wire.

DETAILED DESCRIPTION OF THE INVENTION

A first embodiment of the present Invention is shown in Figure 1. Shown is an unconstrained, non-tensioned embolic filter assembly 30 of the present invention. The filter assembly 30 comprises a frame 31 having two distinct portions: a filter support

0 portion 32 and a series of looped struts or tethers 34. Each looped strut 34 is affixed to a central collar 46, which is then attached to a support wire 36 at attachment point 38. Multiple struts 34 emanate radially outward and are attached to the frame's filter support portion 32. Attached to the filter support portion 32 is a filter element 40. Also shown is a longitudinal axis 42, which is essentially coincident with the support wire 36.

5 Embolic filter frames can have 2, 3, 4, 5, 6, 7, 8 or more looped support struts.

The number of support struts can effect the profile and shape of the filter membrane opening 60. For example, the frame configuration in Figure 1, showing only three support struts for clarity, typically results in a filter opening having three scallops 41 which follow the profile of the filter support portion 32. By incorporating additional support struts, the magnitude or size of each scallop 41 is reduced and the filter opening will more closely approximate a circle within a plane. In a preferred embodiment, six looped support struts are incorporated into a frame of the present invention. The filter element may be trimmed to match the contour of the scallops so to avoid deflecting or disrupting fluid flow or potentially allowing inadvertent passage of emboli.

The distal end 35 of the filter element is preferably provided with a slidable attachment around the support wire 36 so as to allow the filter element to change

2017204628 03 Jul 2019 position relative to the support wire 36 between compacted and deployed dimensions. Additionally, a slidable interface between the distal end 35 and the support element allows the filter element to remain fully extended in the vessel at all times, even when the filter assembly is undergoing longitudinal compliance, as described herein. Alternatively or additionally, the filter element may be formed from an elastic material that can accommodate different distal end positions relative to the position of the filter frame.

Shown in Figure 2 is an enlarged view of the unconstrained looped support struts of an embolic filter 30 of the present invention. Shown is a frame 31 having filter support portions 32 and three looped support struts 34. Also shown are support wire 36, central collar 46, collar to support wire attachment point 38, and a filter element 40. Shown is a preferred embodiment in which the looped support struts 34 are essentially s shaped.

Figure 3A illustrates the unconstrained embolic filter assembly 30 from Figures 1 and 2. Shown are three preferred s-shaped, looped support struts 34 extending radially from the central collar 46. The support struts 34 extend from and are attached to a filter support portion 32. Attached to the filter support portion 32 is a filter element 40. The embolic filter 30, shown in an unconstrained state, has an unconstrained diameter 44.

Referring again to Figure 2, shown are three looped support struts 34, support wire 36, central collar 46, collar to support wire attachment point 38, and a filter element 40. It will be noted that attachment point 38 may comprise a rigidly secure fixation point between the support wire 36 and the centered collar 46, or it may comprise a slideable interface between the support wire 36 and central collar 46; thereby decoupling longitudinal or rotational motion of the support wire from the filter frame. The support struts 34 extend radially and are attached to a filter support portion 32. Attached to the filter support portion 32 is a filter element 40. A filter support portion is defined as that portion of a filter frame that is at least partially attached to a filter element 40. A support strut is defined as that portion of a filter frame that supports the filter support portion and generally is not attached directly to the filter element 40.

A looped support strut is further illustrated in Figure 3B. Shown is the support strut 34 unattached to a filter element and constrained about a support wire or longitudinal axis 42. A reference axis 47, drawn through the support strut 34 as shown, approximates the magnitude of a bend or loop in the support strut. The axis 47 defines an angle 48 relative to the longitudinal axis 42 (also shown is a reference axis 49 which defines a 90 degree angle relative to the longitudinal axis 42). Shown is a looped

2017204628 03 Jul 2019 support strut angle 48, which is greater than 90 degrees, relative to the longitudinal axis 42. A looped strut is therefore defined as a filter frame support strut, having a portion unattached to a filter element, wherein the strut has at least one bend equal to or greater than 90 degrees along the unattached portion. The looped angle can be viewed and measured about any axis.

A looped, embolic filter frame support strut having an s shape is depicted in Figure 3C. Shown is the support strut 34 unattached to a filter element and constrained about a longitudinal axis 42. Also shown is an axis 37, which is parallel to the longitudinal axis 42. A reference axis 47, drawn through the support strut 34, as io shown, approximates the magnitude of the bends or loops in the support strut. The axis 47 defines angles 48 relative to the longitudinal axis 42. Shown are two opposite bend angles 48, each of at least about 90 degrees. A support strut having an 's' shape is defined as a filter frame support strut having a portion unattached to a filter element, wherein the strut has at least two opposite bends greater than about 90 15 degrees along the unattached portion. The angles 48 can be viewed and measured about any axis.

The aspect of longitudinal compliance is further clarified in Figure 4. Shown is an embolic filter assembly 30 of the present invention deployed within a compliant vessel 50 (shown in longitudinal cross-section). The vessel 50 defines an inner

0 diameter which is slightly smaller, for example approximately 90%, than the unconstrained diameter of the device. This is shown as diameter 44 in Figure 3A. The under-sized vessel therefore imparts a radial constraint to the deployed filter, which prevents the filter from expanding to a full, unconstrained diameter. In this process, an interference fit between the filter and vessel wall is achieved. The looped support struts 25 34 when constrained by a vessel therefore exert a radial or expansive force 52 onto the vessel wall 50, forming a seal region 54. This radial, expansive force 52 can also be referred to as the hoop stress or radial force applied to the vessel wall.

As the term unconstrained diameter is used herein, it is intended to describe the device of the present invention as it self-deploys on a tabletop. In this form it is both 30 unconstrained and untensioned. This state is also referred to herein as being not in tension or in a non-tensioned state.

Once deployed, the support wire 36, when rigidly fixed at or about the central collar, can be slightly displaced along the longitudinal axis 42 in directions 56 or 58 without significantly disrupting or translating to the seal region 54. The looped support 35 struts 34 therefore provide a degree of longitudinal compliance which effectively isolates the filter element from small support wire displacements. Devices of the present invention having unconstrained diameters of about 6mm (0.24) can tolerate

2017204628 03 Jul 2019 support wire displacements in directions 56 or 58 of about +/- 0.8mm (+/-0.03) or more, without causing a significant disruption or translation to the seal region 54. The support wire therefore has a maximum total displacement” before causing a disruption to the seal region 54.

Longitudinal compliance can be alternately expressed as a ratio of unconstrained diameter divided by the maximum total support wire displacement when rigidly fixed to the support wire (without disrupting or translating the seal region against the vessel wall). To determine this ratio, a device of the present invention can be deployed within a transparent elastic tube having a diameter of about 80% of the filter's io unconstrained diameter. The maximum total support wire displacement (without disrupting or moving the seal region) can then be approximated. Devices of the present invention display ratios of unconstrained diameter divided by the maximum total displacement of the support wire of about 6 or less. Preferably, the embolic filter of the present invention has a ratio of unconstrained diameter to maximum support wire displacement of about 5, about 4, about 3, about 2.5, about 2, about 1.5, about 1.2, or about 1.

A relatively easy test to quantify longitudinal compliance in the present invention is to deploy the filter apparatus within a silicone tube (such as that available from JAMAK Healthcare Technologies, Weatherford, TX) having a thin wall thickness 2 0 of approximately 0.25 mm (0.01) and having an internal diameter of approximately

80% that of the unconstrained filter apparatus. It should be noted that the use of an 80% constrained diameter is preferred since a 20% interference fit between the device and the vessel will prevent device migration and provide adequate sealing. Once deployed and at body temperature (approximately 37°C), the support wire to which the 25 apparatus is attached may be longitudinally manipulated. The maximum distance the support wire can be displaced (in a longitudinal direction) without moving the filter frame in relation to the silicone tubing is recorded as longitudinal compliance.

The present invention also has the beneficial feature of a short deployed length, as depicted in Figures 5A through 5D. The short deployed length of the present invention is a result of the looped struts and the central collar connecting the support struts to the support wire being positioned essentially within the plane of the filter opening. Depending upon the demands of particular applications, the looped struts can be engineered to deploy to be directly within the plane of the opening to the filter element, slightly upstream of the opening, or even slightly downstream of the opening so as to orient within the filter frame element itself. Shown in Figure 5A is an embolic filter 30 of the present invention in an unconstrained state having a proximal end 43 and a distal end 45. The filter element 40 has a filter opening 60, which defines a io

2017204628 03 Jul 2019 plane having an x-axis 62 and a y-axis 64. For filter openings with scallops 41, the opening axis 62 and 64 are positioned at the most proximal ends of the scallops 41. The opening plane shown is orthogonal to the support wire 36 and the longitudinal axis 42. The two axes 62, 64 therefore define the plane of the filter opening 60. Looped struts 34, of the present invention are joined onto a central collar 46, which is attached to the support wire 36 at attachment point 38 via either rigidly fixed or slideable means.

Shown in Figure 5B is a filter element 40 having a filter opening 60, a y-axis 64, and a longitudinal axis 42. The axis 64 is an edge-view of the plane of the filter opening. Axes 42 and 64 intersect at point 70. Point 70 is therefore on the plane ofthe io filter opening. For clarity, a point or location on the longitudinal axis 42 is considered to be offset distally from the plane of the filter opening if the point lies within the filter element in the longitudinal direction labeled 72. Conversely, a point or location on the longitudinal axis 42 is considered to be offset proximally from the plane ofthe filter opening if the point lies outside of the filter element in the longitudinal direction labeled 15 74.

Figure 5C illustrates a looped support strut 34 and central collar 46 of the present invention having a support wire attachment point 38 which is rigidly fixed to the support wire and off-set distally from the plane of the filter opening 64. Shown is a support wire attachment point 38 positioned inside the filter element 40 in the distal

0 direction 72. The magnitude ofthe attachment point offset is shown as element 80.

Figure 5D illustrates a looped support strut 34 and central collar 46 of the present invention having a support wire attachment point 38 which is rigidly fixed to the support wire and off-set proximally from the plane of the filter opening 64. Shown is a support wire attachment point 38, positioned outside of the filter element 40, in the 25 proximal direction 74. The magnitude ofthe attachment point offset is shown as item 82.

The relative magnitude of any off-set, along with the direction of the off-set between a support wire attachment point and the plane of the filter opening 64, can be expressed by an offset ratio of the strut attachment point off-set divided by the unconstrained diameter 44. For example, a filter having a strut attachment point offset of 4mm and an unconstrained diameter of 10mm, would have a ratio of 0.4. This ratio can be applied to strut to support wire attachment points that are offset distally or proximally to the plane of the filter opening. A ratio of zero would reflect no offset, or in other words an attachment point lying in the plane of the filter opening.

Embolic filters of the present invention can have distally offset ratios (of the attachment point off-set divided the unconstrained diameter) ranging from about 0 to about 1, with a preferred range of about 0 to about 0.7, with a most preferred range of

2017204628 03 Jul 2019 about 0.2 to about 0.5. These distally offset ratios reflect strut/collar to support wire attachments positioned within the filter element. Similarly, embolic filter of the present invention can have proximally offset ratios, reflecting strut/collar to support wire attachments positioned outside of the filter element. In these configurations, embolic filters of the present invention can have offset ratios (attachment point offset divided by the unconstrained diameter) ranging from about 0 to about 1.

Devices of the present invention can be configured to have a strut to central collar attachment points that are significantly different than the central collar to support wire attachment points. For these configurations, both attachment points are then io approximated by a point on the support wire that is in closest proximity to the strut.

The looped support struts of the present invention allow a short deployed length that enhances navigation within tortuous vessels and allows deployment near vascular side-branches. To quantify as having the aspect of short deployed length, a device should be defined by at least one of the five ratios defined below.

The deployed length of a filter can be expressed by a first ratio of the deployed length divided by the unconstrained diameter of the filter. Shown in Figure 6A is an embolic filter 30 of the present invention having a filter element 40, looped struts 34, strut/collar to support wire attachment point 38 (lying outside of the filter element), and an unconstrained diameter 44. Shown is a deployed length 84, which includes the

0 looped struts 34 and the attachment point 38.

Shown in Figure 6B is an embolic filter 30 of the present invention having a filter element 40, looped struts 34a, strut/collar to support wire attachment point 38 (lying within the filter element), and an unconstrained diameter 44. Shown is a deployed length 86, which is referenced from the opposing ends of the filter element, and does

5 not include the looped struts 34a or the attachment point 38.

Embolic filters of the present invention can have ratios of the deployed length 84, 86 divided by the filter unconstrained diameter 44, ranging from about 0.5 to about 7, with a preferred range of about 1 to about 5, with a most preferred range of about 2 to about 4.

A similar expression of a filter deployed length or footprint is a second ratio of the deployed length of the frame (not including a filter element) divided by the frame unconstrained diameter. Shown in Figure 6C is an embolic filter frame of the present invention having filter support portions 32 and looped struts 34, strut/collar to support wire attachment point 38 (lying outside of the filter element 40), and a unconstrained frame diameter 44. Shown is a frame deployed length 87, which does not include the filter element 40.

Shown in Figure 6D is an embolic filter frame of the present invention having

2017204628 03 Jul 2019 filter support portions 32 and looped struts 34, strut/collar to support wire attachment point 38 (lying within the filter element 40), and an unconstrained diameter 44. Shown is a frame deployed length 88, which does not include the filter element 40.

Embolic filters of the present invention can have ratios of the frame deployed length 87, 88 divided by the frame unconstrained diameter 44, ranging from about 0.1 to about 7, with a preferred range of about 0.3 to about 2, with a most preferred range of about 0.5 to about 1.

Additional benefits of the looped struts of the present invention relate to the delivery aspects of the embolic filter as shown in Figures 7A through 7D. The looped io support struts of the present invention when tensioned elongate and assume a compacted and essentially linear form. While constrained in this linear state by a delivery catheter or other constraint means, the support struts exert relatively little force onto the radial constraint means, which permits the radial constraint means to be very thin and/or delicate. The overall delivery profile and stiffness are therefore reduced over those required for prior embolic filter devices. When the delivery catheter constraint is removed during deployment, the struts of the present invention spontaneously open and assume a looped configuration, which exert a high degree of force onto the vessel wall, creating an enhanced filter to vessel wall seal.

Shown in Figure 7A is an embolic filter 30 of the present invention having

0 looped struts 34 attached to a central collar 46. The central collar is attached to a support wire 36. The support struts emanate radially outward and are integral to (or joined to) a frame having a filter support portion 32. A filter element 40 is attached to the filter support portion 32.

When tension 90 is applied to the support wire 36 and filter element 40, the 2 5 looped struts 34 elastically deform to the configuration shown in Figure 7B. As further tension 90 is applied, the embolic filter 30 and the looped struts 34 continue to elongate until the looped struts assume an essentially linear or straight form as shown in Figure 7C. While in this elongated state, the embolic filter 30 can be inserted into a delivery catheter or withdrawn into a sheath. Shown in Figure 7D is an elongated 30 embolic filter 30 of the present invention having looped struts 34 in an essentially linear configuration constrained in a delivery catheter 92. The low force applied to the delivery catheter by the elongated looped strut facilitates use of a relatively thin catheter wall 94. When the constraining delivery catheter is removed during filter deployment, the looped struts of the present invention spontaneously open and assume the configuration shown in Figures 4 and 7A, either spontaneously or through manipulation of the support wire and/or delivery catheter.

During delivery within a vessel, struts 34 of an embolic filter of the present

2017204628 03 Jul 2019 invention are constrained in an essentially linear form, as shown in Figure 7D. While in this essentially linear form, the central support collar 46 (or strut to support wire attachment point 38) is positioned outside of the filter element 40. The central support collar 46 is also separated from the filter element 40 by the elongated and essentially linear support struts 34. Once properly deployed, however, the central support collar (or strut to support wire attachment point 38) lies within the filter element 40, as shown in Figure 7A. The central support collar 46 (or strut to support wire attachment point 38) therefore moves or translates relative to the filter element during deployment. Typical filters of the present invention undergo a relative translation (support collar to io filter element) equal to at least 1/2 of the length of the constrained filter element 96 (as is shown in Figure 7D).

Also shown in Figure 7D is a total constrained delivery length 97 of an embolic filter of the present invention. Embolic filters of the present invention can have a third ratio of the total constrained delivery length 97 divided by the unconstrained length. For 15 the present invention, this third ratio may be about 1, about 2, about 2.5, about 3, about 3.5, or greater. The unconstrained length is defined by length 84 (Figure 6A) or by length 86 (Figure 6B).

Similarly, embolic filters of the present invention can have a fourth ratio of the total constrained frame delivery length 98 divided by the unconstrained frame length.

0 For the present invention, this fourth ratio may be about 2, about 2.5, about 3, about

3.5, or greater. The unconstrained frame length is defined by length 87 (Figure 6C) or by length 88 (Figure 6D).

A fifth ratio relating to the short deployed length is the strut constrained delivery length divided by the strut unconstrained deployed length. The strut constrained delivery length is defined as the length of a strut portion 34 of the frame, not including the filter support portion 32, as shown in Figure 7D. The strut constrained delivery length is therefore a portion of the total frame length 98 in Figure 7D. The strut unconstrained length is defined as the length of an unconstrained strut 34a as shown in Figures 6C and 6D, not including the length of a filter support portion 32. Filter frames of the present invention can have ratios of the strut constrained delivery length divided by the strut unconstrained deployed length of about 2, of about 3, of about 4, of about 5, of about 6, of about 7, or more. Filter frames of the present invention preferably have ratios of the strut constrained delivery length divided by the strut unconstrained deployed length of about 3, of about 3.5, of about 4, of about 4.5, or about 5 or more. Most preferred ratios of strut constrained delivery length divided by the strut unconstrained deployed length are about 3, about 3.3, of about 3.6, or about 4, or more.

2017204628 03 Jul 2019

Embolic filters of the present invention can be produced using a variety of common methods and processes. For example, an embolic filter frame with looped struts can be fabricated from any biocompatible material having adequate resilience and stiffness. For example, nitinol, stainless steel, titanium, and polymers may be 5 employed as applicable materials. A precursor frame having looped struts may be fabricated in a planar sheet form and rolled and attached to itself to form a frame of the present invention. Alternately, a cylindrical tube can be cut and expanded or cut and compressed to form a frame of the present invention. Cutting processes can include lasers, stampings, etching, mill-cutting, water-jets, electrical discharge machining, or io any other suitable process.

Filter elements or members, used in conjunction with the looped struts of the present invention, can be produced using a variety of common materials, methods and processes. Suitable biocompatible materials include, but are not limited to, metallic foilsor meshes, or sheets or meshes formed from various polymers, including fluoropolymers such as polytetrafluoroethylene. Filter members can be molded, cast, formed, or otherwise fabricated by joining various suitable materials.

Figures 8 through 12 illustrate (but do not limit) various alternate embodiments of looped struts of the present invention. Shown in Figures 8A and 8B is an embolic filter 30 having a preferred looped strut configuration 34. A preferred strut 34 of the 2 0 present invention can have a looped shape or profile when viewed along two orthogonal axes. The struts 34 therefore project a looped configuration in two orthogonal views.

Alternate strut configurations of the present invention can have looped shapes when viewed along different combinations of axes or along a single axis. For example, 2 5 shown in Figures 9A and 9B are similar views to those of 8A and 8B, showing an alternate looped strut configuration wherein the alternate strut 34 has an essentially looped shape only when viewed along a single axis. Shown is a strut 34 having a looped shape in an end view (Figure 9A) and an essentially linear shape in a side view (Figure 9B).

Alternately, a strut of the present invention can have an essentially linear shape when viewed on end, while having a looped shape when viewed, for example from the side. This configuration is illustrated in Figures 10A and 10B, which show an alternate strut 34 having an essentially linear shape when viewed from the end (Figure 10A), while having a looped configuration when viewed from the side (Figure 10B).

Looped support struts of the present invention can be configured with bends greater than about 90 degrees (as defined by Figure 3C), greater than about 120 degrees, greater than about 180 degrees, greater than about 240 degrees, or more.

2017204628 03 Jul 2019

For example, a looped strut of the present invention having a bend greater than about 200 degrees is depicted in Figure 11 A. Shown is an embolic filter 30 having looped support struts 34 with spiral bends of about 200 degrees or more. The struts 34 also have a looped configuration when viewed from another axis, in this case a side view, as shown in Figure 11B. Looped support struts of the present invention can therefore have different loop configurations when projected onto different viewing planes.

Shown in all Figures 8 through 11 are embolic filters having three, looped support struts with support wire attachment points 38 and central support collars 46, lying essentially within the filter element, as previously described in Figures 5A and 5B.

o Embolic filter frames of the present invention can have 2, 3, 4, 5, 6, 7, 8, or more looped support struts. Various multiple strut configurations are depicted in Figures 12A through 12F.

Figure 12A shows an end view of an embolic filter of the present invention having 3 looped struts 34.

Figure 12B shows an end view of an embolic filter of the present invention having 4 looped struts 34.

Figure 12C shows an end view of an embolic filter of the present invention having 5 looped struts 34.

Figure 12D shows an end view of an embolic filter of the present invention

0 having 6 looped struts 34.

Figure 12E shows an end view of an embolic filter of the present invention having 7 looped struts 34.

Figure 12F shows an end view of an embolic filter of the present invention having 8 looped struts 34.

An additional functional aspect of embolic filter frames of the present invention is shown in Figure 13. Shown is an embolic filter 30 having looped support struts 34, filter element 40 attached to the filter element support 32, central collar 46, and support wire 36. When deployed within an undersized vessel (that is, a vessel that is undersized relative to the filter's relaxed fully deployed diameter), a compressive load

100 is applied to the frame, which counteracts the radial force applied by the frame to the vessel. The compressive load 100 causes a frame portion, in this case the filter element support portion 32, to deflect outwardly, as shown by item 102. The deflection 102 can improve the sealing between the filter element 40 and the vessel wall, further reducing the advertent passage of emboli. The additional loading onto the vessel wall can also reduce the possibility of vascular trauma caused by relative motion between the filter and the vessel, and opposition when deployed in curved vascular segments.

Shown in Figure 14 is an alternate configuration of a frame having looped struts

2017204628 03 Jul 2019 and having a simplified filter support portion (in contrast to the elongated filter support portions 32 shown in Figure 2). Shown are a support wire 36 and a filter element 40 attached directly to the ends of the six looped support struts 34 of the present invention. The support struts 34 attach to the filter element 40 at attachment points 103. It should be appreciated that the length and shape of the struts 34 in this embodiment may be varied to accommodate bonding of struts 34 to different points on the filter element or to bond the filter element 40 along a partial length of the struts 34.

An additional feature of a filter frame of the present invention relates to the looped strut spontaneous transformation from a constrained linear state to a locked and inverted state, similar to that of locking pliers or an off-center locking clamp. Once inverted, the looped struts maintain a stable, short length, looped configuration and must be tensioned to revert back to the constrained linear state.

The term support wire, as referred to and relating to the present invention, (for example, element 36 in Figure 1) can include a solid or hollow support wire or can include any other tubular article with at least one continuous lumen running therethrough. A suitable support wire for use with the present invention may include, but is not limited to, a guide wire.

Filters of the present invention can be configured for deployment within a variety of articles, including, but not limited to, filtering applications within animal vessels, catheters, pipes, ducts, fluid conduits, tubes, hoses, material transfer conduits, storage containers, pumps, valves and other fluid containers. Filterable fluids include gasses, liquids, plasma and flowable solids or particulate mixtures. Fluids can flow across the filters of the present invention, or the filters can be dragged or otherwise transported through a fluid. Filters of the present invention are not limited to generally circular profiles (when viewed on end) and can have, when deployed an oval, triangular, square, polygon, or other profile. Filters of the present invention can also be combined, ganged, or used in conjunction with other devices such as diagnostic, visualization, therapeutic instruments, or other filters. The strut configurations of the present invention can also be incorporated into non-filtering devices, such as vessel occluders, indwelling diagnostic instruments, therapeutic instruments, or visualization devices.

Without intending to limit the scope of the present invention, the device and the method of production of the present invention may be better understood by referring to the following example.

EXAMPLE 1

As shown in Figure 15, a 0.9 mm nitinol tube 104, with a wall thickness of

2017204628 03 Jul 2019 approximately 0.09mm (obtained from SMA Inc, San Jose, CA) was laser cut by Laserage Technologies Inc, Waukegan, IL, to form a frame configuration of a single, undulating, integral, 6 apex ring. The frame included radiopaque marker housings 106 at each distal apex and tether or strut elements 34 extending from each proximal apex 5 108 and converging at the opposite end in a collar 46 of uncut parent material. This frame was then lightly grit blasted at 30 psi with 20-micron silicon carbide media in a grit blasting machine (Model MB1000 available from Comco Inc, Burbank, CA). The frame was then gently slid up a tapered mandrel until it achieved a functional size of approximately 6mm.

io The frame and mandrel were then subjected to an initial thermal treatment to set the geometry in an initial, tapered (conical) configuration in an air convection oven (Carbolite Corporation, Sheffield, England). The frame was quenched in ambient temperature water and removed from the mandrel, resulting in a non-inverted frame.

Shown in Figure 16 is the non-inverted frame 110 having support struts 34, a central collar 46, apexes 108, and radiopaque marker housings 106. The frame portion distal to the apexes 108 form a filter element support portion 32. The frame was then placed on a second mandrel, designed to constrain the outside of the frame while allowing the inversion of the tether elements back upon themselves. Once constrained in the proper configuration, the tooling and frame were subjected to a second thermal

0 treatment to set the final frame geometry and to set the nitinol transition to an appropriate temperature. The resulting inverted frame is depicted in Figure 17.

Shown in Figure 17 is an inverted frame 112 having six looped support struts 34a, apexes 108, radiopaque housings 106, and an integral central collar 46. The frame portion distal to the apexes 108 form a filter element support portion 32.

One skilled in the art will appreciate that variances in the filter frame material(s), dimensions, geometry, and/or processing can all be made to create alternate embodiments with varying desirable properties. For example, the relative position of the central collar 46 to the apexes 108 can be varied according to Figures 5C and 5D.

The frame (now at functional size and preferred geometry) was then lightly coated with fluorinated ethylene propylene (FEP) powder (e.g., FEP 5101, available from DuPont Corp, Wilmington, DE) by first stirring the powder in a kitchen blender (Hamilton Beach Blendmaster) after the powder was mixed into a cloud, the frame was lowered into the blender for approximately 5 seconds (enough time for FEP to build up onto the surface of the frame). The frame, coated with FEP powder, was placed in an air convection oven (Grieve Oven, The Grieve Corporation, Round Lake, IL) set at 320°C for approximately one minute followed by air cooling to room temperature.

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A typical filtering media was made by laser perforating one layer of a thin, polytetrafluoroethylene (PTFE) membrane using a 10-watt CO2 laser. The membrane thickness measured about 0.0002 (0.005 mm) and had tensile strengths of about 49,000 psi (about 340 KPa) in a first direction and of about 17,000 psi (about 120 KPa) 5 in a second direction (perpendicular to the first direction). The tensile measurements were performed at 200mm/min. load rate with a 1 (2.5 cm) jaw spacing. The membrane had a density of about 2.14g/cm³. The laser power and shutter time parameters were adjusted to allow the laser to consistently create uniform 0.004 (0.1 mm) diameter holes in the membrane. The hole pattern geometry was then adjusted to 10 create a pattern with uniform hole size, uniform hole spacing, and uniform strength throughout the pattern. This perforated pattern was then folded on itself and heatsealed using a local heat source (Weber soldering iron, EC2002M, (available through McMaster Carr, Santa Fe Springs, CA)) into a pattern which would result in a conical shape. The conical flat pattern was then trimmed with scissors, inverted, and mounted 15 upon the FEP powder coated NiTi frame and attached through the application of localized heat (the heat causing the FEP coating on the frame to re-melt and flow onto the surface of the filter sack thus providing a biocompatable thermoplastic adhesive).

A guide wire component was then inserted into the collar end of the frame and a small amount of instant adhesive (Loctite 401, Loctite Corp, Rocky Hill, CT) was 20 applied and dried to adhere and create a smooth transition from the guide wire to the outer diameter (OD) of the frame collar. One skilled in the art will realize that attachment of the filter to the guide wire could be accomplished by adhesion, welding, soldering, brazing, a combination of these, or a number of other methods.

The resulting embolic filter is as shown and described above with respect to 25 Figure 1 et seq.

A further embodiment of the present invention is illustrated in Figures 18A through 18C. In this embodiment the filter assembly 30 includes a frame 31 that is slidably mounted to the support wire 36. This attachment may be accomplished through a variety of means, including by providing a collar 46 that is sized slightly 30 larger than the support wire 36 to allow the collar to move relative to the support wire when in use. Stops 114a, 114b are provided on the support wire 36 to limit the range of relative movement between the filter assembly 30 and the support wire 36. Constructed in this manner, the filter assembly 30 has exceptional longitudinal compliance relative to the support wire in that the support wire can freely move 35 between the stops 114 without translating longitudinal or rotational movement to the filter assembly. The full range of proximal and distal movement of the filter assembly 30 relative to the stops 114 is shown in Figures 18B and 18C.

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While particular embodiments of the present invention have been illustrated and described herein, the present invention should not be limited to such illustrations and descriptions. It should be apparent that changes and modifications may be incorporated and embodied as part of the present invention within the scope of the following claims.

It is to be understood that, if any prior art publication is referred to herein, such reference does not constitute an admission that the publication forms a part of the common general knowledge in the art, in Australia or any other country.

In the claims which follow and in the preceding description of the invention, io except where the context requires otherwise due to express language or necessary implication, the word comprise or variations such as comprises or comprising is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

Claims (18)

1. A medical device comprising:

a frame that is compressible and has a longitudinal axis, a periphery located

5 around and orthogonal to the longitudinal axis, a proximal end defining a plane, and a distal end, the frame including a plurality of support struts extending from the periphery toward the longitudinal axis of the frame, each of support struts having a curved shape and each of the support struts being generally coplanar with one another such that each of the support struts has the curved shape when viewed along the longitudinal io axis and an essentially linear shape when viewed from a side; and a membrane coupled to the frame.

2. The medical device of claim 1, further including a collar disposed about the longitudinal axis of the frame such that the plurality of support struts extend between

15 the collar and the periphery of the frame.

3. The medical device of claim 2, wherein the collar is located at the proximal end of the frame.

2 0

4. The medical device of claim 2 or claim 3, wherein the collar and the plurality of support struts are coplanar.

5. The medical device of any one of the preceding claims, wherein each of the plurality of support struts is s-shaped.

6. The medical device of any one of the preceding claims, wherein the periphery of the frame is defined by a plurality of peripheral struts, the peripheral struts extending between the proximal and distal ends of the frame.

30

7. The medical device of any one of the preceding claims, wherein the plurality of support struts are formed from a tube of shape memory material cut to form the collar and the plurality of support struts.

8. The medical device of any one of the preceding claims, wherein the medical

35 device is an occluder.

2017204628 03 Jul 2019

9. The medical device of any one of the preceding claims, wherein the membrane is configured to substantially obstruct fluid from flowing through the medical device.

10. The medical device of any one of claims 1-7, wherein the medical device is a

5 filter.

11. A medical device comprising:

a frame having a longitudinal axis and including a collar, a plurality of curved support struts, and a support portion radially offset from the collar and having a io proximal end and a distal end, the plurality of support struts extending from the proximal end of the support portion to the collar such that the collar is longitudinally aligned with the proximal end of the support portion and such that each of the support struts is coplanar with one another and has a curved shape when viewed along the longitudinal axis and an essentially linear shape when viewed from a side; and

15 a membrane coupled to the frame.

12. The medical device of claim 11, wherein each support strut is s-shaped.

13. The medical device of claim 11 or claim 12, wherein the plurality of support struts 2 0 and the collar are coplanar.

14. The medical device of any one of claims 11-13, wherein the plurality of support struts are formed from a single piece of precursor material including a tube of shape memory material cut to form a single ring that defines the collar, the support portion,

2 5 and the plurality of support struts.

15. The medical device of any one of claims 11-14, wherein the support portion includes a second plurality of support struts, the second plurality of support struts extending between the proximal and distal ends of the frame.

16. The medical device of any one of claims 11-15, wherein the medical device is an occlusive device.

17. The medical device of any one of claims 11-16, wherein the membrane is

35 configured to substantially obstruct fluid from flowing through the medical device.

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18. The medical device of any one of claims 11-15, wherein the medical device is a filter.