MXPA00004382A - An embolic protection device - Google Patents
An embolic protection deviceInfo
- Publication number
- MXPA00004382A MXPA00004382A MXPA/A/2000/004382A MXPA00004382A MXPA00004382A MX PA00004382 A MXPA00004382 A MX PA00004382A MX PA00004382 A MXPA00004382 A MX PA00004382A MX PA00004382 A MXPA00004382 A MX PA00004382A
- Authority
- MX
- Mexico
- Prior art keywords
- filter body
- filter
- compliant device
- catheter
- distal
- Prior art date
Links
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Abstract
An embolic protection device has a collapsible filter element (105) mounted on a carrier such as a guidewire (101). The filter element (105) collapses into the outer end of a catheter (118) for deployment and retrieval through a vascular system of a patient. The filter element (105) has a collapsible filter body with a proximal inlet end and a distal outlet end. The proximal inlet end has inlet openings sized to allow blood and embolic material enter the filter body. The outlet end has outlet openings which allow through passage of blood but retain embolic material within the filter body. After use, the catheter (118) is movable along the guidewire (101) to engage the proximal end of the filter element and close the inlet openings before sliding over the filter element from the proximal end to the distal end to progressively collapse the filter body on the guidewire (101) for retrieval. The filter element (105) may conveniently be mounted on a tubular sleeve (104) which is slidable and rotatable on the guidewire (101) between spaced-apart stops (106, 120) on the guidewire (101) which allows some manipulation of the guidewire independently of the filter when the filter is in use.
Description
? N EMBOLIC PROTECTION DEVICE
Introduction The invention relates to an embolic protection device. The term "ATTACK" is used to describe a medical event whereby the blood supply to the brain or to specific areas of the brain is restricted and blocked to the degree that the supply is inadequate to provide the required flow of oxygenated blood to maintain function. . The brain will be damaged either temporarily or permanently, with the patient experiencing a loss of function such as sight, speech or control of their extremities. There are two different types of attack, hemorrhagic and embolic. This invention is directed to embolic attack. The medical literature describes carotid artery disease as a significant source of embolic material. Typically, an atherosclerotic plaque builds up in the carotid arteries. The nature of the plaque varies considerably, but in a significant number of cases pieces of the plaque can rupture and flow distally and block blood flow to specific areas of the brain and cause neurological damage. The treatment of the disease is classically by means of a surgical carotid endarterectomy whereby the carotid artery is cut and the
^ jfa plate is physically removed from the vessel. The procedure is widely accepted with rates of neurological complication rated as very low, something of the order of 6 percent although widely claimed variation is claimed. Not all patients are candidates for surgery.
Some reasons may exist so that patients can not tolerate the surgical intervention. In these cases and in a growing number of candidates who are surgical candidates, they are being treated using transcatheter techniques. In this case, the evolution approach uses devices inserted into the femoral artery and manipulated to the site of the stenosis. An angioplastic balloon is inflated into a catheter to open the artery and an intravascular stent is sometimes deployed at the site of the stenosis. The action of these devices as with surgery can discharge embolic material which will flow with arterial blood and if it is large enough, it will eventually block a blood vessel and cause an attack. It is known to permanently implant a filter in the human vasculature to capture the embolic material. It is also known to use a removable filter for this purpose. These removable filters typically comprise umbrella-type filters comprising a filter membrane supported on a collapsible structure on a guide wire for movement of the filter membrane between a collapsed position against the guide wire and a laterally extended position that covers a vessel. Examples of these filters are shown in U.S. Patent Nos. 4723549, 5053008, 5108419 and WO 98/33443. Several deployment and / or collapse arrangements are provided for the umbrella filter. However, as the filter collapses, the captured embolic material tends to press out towards an open end of the filter and pieces of the embolic material can escape the filter with potentially catastrophic results. More usually, the umbrella filter collapses against the guidewire before removal through a catheter or the like. Again, as the filter membrane collapses, it will tend to oppress the embolic material. In addition, the umbrella filter is generally fixed to the guide wire and inadvertently the movement of the guide wire during an intervention procedure can discharge the filter. The present invention is directed towards overcoming these problems. There is a need for an embolic protection device that overcomes this problem. Declarations of the Invention According to the invention, there is provided an embolic protection device comprising: a collapsible filter element mounted on a
^^ 3 & '| ^ | ^ í ^^^^^^ ^^^^^^^ filter holder to supply through a vascular system of a patient, the element being movable between a stored position filter collapsed against the filter carrier for movement through the vascular system and an extended position for occluding a blood vessel such that blood passing through the blood vessel is delivered through the filter element, wherein the element The filter comprises a collapsible filter body having an inlet end and an outlet end, the inlet end of the filter body having one or more suitable inlet openings to allow the blood and embolic material to enter the body of the filter body. filter, the outlet end of the filter body has a plurality of outlet openings suitable for the size to allow the passage of blood through it but retain the unwanted embolic material inside the body of the filter. the filter, and means for closing the inlet openings at the inlet end of the filter body. Advantageously, the filter inlet openings close before the filter collapses ensuring retention of all embolic material within the filter element.
. '* • »" "In a particularly preferred embodiment of the invention, the means for closing the inlet comprises: a retrieval device tubular filter having an open distal end for reception of the filter element, the engageable distal end being with one end proximal inlet of the filter body to close the inlet openings and being slidable over the filter body from the inlet end towards the outlet end to progressively collapse the filter body on the filter carrier and receive the filter body within the retrieval device. conveniently, the retrieval device may be a catheter or pod or the like which engages and collapses the filter element firstly closing the inlet openings to prevent any escape of embolic material and then collapsing the rest of the filter, sliding from the proximal end over the filter to the distal end of the filter. tro. In a particularly preferred embodiment, the element collapsible filter is mounted slidably on the filter carrier between a pair of spaced apart on the filter carrier for axial movement of the filter element along the filter carrier arrests between arrests . Advantageously, the filter carrier, which may be a guide wire for example, can be moved independently of the filter element and thus the accidental movement of the guide wire is accommodated without unintentionally moving the filter, for example, during the change of the filter. medical devices . In another embodiment, the filter element is rotatably mounted on the filter holder. In a preferred embodiment, a sleeve is slidably mounted on the filter holder between stops, the length of the sleeve is less than the distance between the stops, the filter element being mounted on the sleeve. In a particularly preferred embodiment, the filter element comprises: a collapsible filter network mounted on the filter carrier, the filter network moving between a collapsed storage position against the filter carrier and an extended position extending outward from the filter carrier. filter carrier to deploy through a blood vessel. Preferably, the tubular filter retrieval device comprises a catheter slidable along the filter holder, an open distal end of the catheter forming a housing for receiving the filter element. In another embodiment, a proximal entry end of the
filter body is fixed to the filter holder and a distal end of the filter body is slidably mounted on the filter holder, although this arrangement can be reversed. In another embodiment, the distal end of the filter body is attached to a collar that is slidable along the filter holder. In a preferred embodiment a filter support frame is mounted on the filter carrier, the support frame is movable between a collapsed position along the filter holder and an extended outward projecting position to support the filter body in the extended position. In another embodiment, the frame of the filter holder is fixed on the filter holder at a proximal end of the filter body. Preferably, the frame of the filter holder is slidably engaged to the filter holder at the distal end of the filter body. Ideally, the frame of the filter holder is biased towards a normally extended position. In another embodiment, a circumferential groove is provided in the filter body in the middle of the ends of the filter body. In another embodiment, a guide olive is provided on the filter holder distally of the filter body,
j ^ tL¿i3iÍiB & * ßf & *, "~," ~ .. * ~? ~ ~ ^. * ... - .. ,, Í4 £? Í £ &Z & amp; the guide olive has a cylindrical body with a diminished distal end, the cylindrical body being engageable with the distal end of a deployment catheter, the distal distal end projecting out of the deployment catheter 5 to provide a smooth transition between the catheter and the filter carrier. In another mode, the network meets in the filter carrier at each end of the network. In another embodiment of the invention, a
an embolic protection device comprising a filter element for positioning in a desired position, the filter element that provides a path for the blood and that has elements for capturing, retaining and removing unwanted embolic material. In one embodiment of the invention, the path has means for restricting flow to capture undesirable embolic material. In another embodiment of the invention, the filter has a proximal end and a distal end, the openings in the
The proximal end is larger than the openings in the distal end, the openings in the proximal end are adapted to the size to allow the flow of blood and embolic material to enter the filter element and the openings in the distal end conform to the size to allow the blood flow to it
time it captures the unwanted emboli within the element
- -j -Bet * »^ ¿Jt & Filter sfít. In another embodiment of the invention, the filter element includes storage elements for storing undesirable embolic material captured in the filter element. Preferably, the storage element comprises additional storage paths within the filter element. Preferably, the filter element defines a three-dimensional matrix. In another embodiment of the invention, the filter element is of a polymeric porous structure. In another embodiment of the invention, the matrix comprises a porous structure sized to trap embolic material which typically varies in size from about 100 microns to 3500 microns. In yet another embodiment of the invention, the filter element is compressible and / or foldable to load an administration device for administering the filter element to a desired location in the compressed or bent state. In one embodiment of the invention, the filter element has material removed from its structure to aid compression. In another embodiment of the invention, the filter element has material removed from its structure to provide an adaptation to the specific size in relation to the size of the embolic material to be trapped. In another embodiment of the invention, the element of
The filter has paths through the filter body that are intertwined so that the flow rate through the filter can be customized. In another embodiment of the invention, the element of
The filter has a distal end that is lowered so that there is a smooth transition in lateral stiffness to improve manipulation of the filter element in the vascular system. In another embodiment of the invention, the filter element has a smooth distal portion to assist in the
atraumatic transport through the vascular system. Preferably, the filter element has circumferential grooves to reduce the lateral flexibility of the filter element. In another embodiment of the invention, the filter element has a decreased proximal end to facilitate recovery by a removal catheter. In another embodiment of the invention, the filter element has inlet openings that close when pulled back toward a recovery catheter to ensure retention of any collected plunger. In another embodiment of the invention, the filter element has exit openings to the size to capture embolic material of a size large enough to impede the function of an organ receiving a current of
blood from the filter body element. Preferably, the
% í ~.
The filter element is sized to capture embolic material larger than 100 microns. More preferably, the filter element is made the size of capturing embolic material of a size greater than 200 microns. More preferably, the filter element is of the size to capture embolic material of a size greater than 500 microns. In one embodiment of the invention, the filter element is of the size for the complete coverage of the cross section of a vessel that allows the passage of blood and blood components. In yet another embodiment of the invention, there is provided a device having elements for placing on a medical guidewire. In another embodiment of the invention, a device is provided that can be placed under a balloon or stent delivery catheter. In another embodiment of the invention, a device is provided that has elements for insertion through femoral, brachial, radial, subclavian or other artery punctures by means of a transcatheter approach. In one embodiment of the invention, a device for the protection of neurological function is provided which is inserted during the duration of a surgical intervention at or near the site of the surgical opening. It is considered that two devices can be used
It is bilaterally in the left and right carotid arteries allowing enough cerebral blood flow to maintain the neurological function during procedures with a high risk of generating a clot such as in the electrophysiological treatment of coronary arrhythmias. In another embodiment of the invention, a device is provided that includes a delivery catheter in which an external sheath is engageable with the filter element or filter holder to provide thrust during delivery and is removable to allow maximum space in the vascular cross section during an intervention procedure. In one embodiment of the invention, the outer sheath is attached to the filter element or to the filter carrier by a joining element. The joining element can be a removable shrink tube or a removable snap. Preferably the attachment element is a compression connector such as a Tuohy Borst adapter. In another embodiment of the invention, the delivery catheter has a central lumen for at least part of its length to allow it to be entrained on a steerable guidewire. In another embodiment of the invention, the outer sheath is long enough to extend the exterior of the vasculature and moves proximally to release the catheter filter element. In one embodiment of the invention, the delivery catheter has an outer cover extending beyond the pushing element to define a filter retaining sleeve. In another embodiment of the invention, the delivery catheter has a spring component with a localized step-up step to alter rigidity characteristics to conform to the target vasculature. In another embodiment of the invention, the delivery catheter has a spring component with a step that gradually increases localized to alter stiffness characteristics to suit the target vasculature. In another embodiment of the invention, the filter element is mounted on a collapsible support structure which is movable between a collapsed position for deployment and an extended position in use, the elements being provided to retain the support structure in position collapsed Preferably, the support structure comprises support arms. Preferably, the support arms are formed of a material with shape memory or elastic memory. More preferably the support arms are formed of Nitinol. In an embodiment of the invention, the support arms are configured to open coaxially with the filter holder so that they can be restricted for removal by pulling the filter element proximally towards a suitably dimensioned sheath. In another embodiment of the invention, the filter element has a support structure associated with the preformed spiral array so as to provide radial support to the filter element. In another embodiment of the invention, the filter support structure is adapted to bend in the collapsed position when pulled toward the recovery catheter. In another embodiment of the invention, the filter element comprises a polymer component in flexible form. In another embodiment of the invention, the polymer component formed is constructed so that the flow of fluid through the component helps to open the component of the collapsed position. In another embodiment of the invention, the polymer component formed is flexible and opens to make circumferential contact with the vessel wall by using pressure drop across the face of the outlet filter. In another embodiment of the invention the filter element is mounted on a guide wire so that the guide wire is free to rotate and / or move axially independently of the filter. More preferably the wire has complete freedom to rotate independently of the filter and has limited axial movement. The limit of axial movement is determined by stops mounted on or connected to the wire. Ideally, the wire can be moved 100 millimeters in the axial direction independent of the filter. More ideally the wire can move less than 50 mm independently of the filter. This mode facilitates the maintenance of the position of the filter during the exchange of catheters and allows the direction of the wire independent of the filter. In another embodiment of this invention the filter element is attached to the filter assembly at its proximal end and its distal end is free to move relative to the filter assembly and the proximal link in a manner that aids in the collapse of the filter for deployment . In another embodiment of the invention, the filter element is lowered over part or all of its length so that it precisely fits the glass on some portion of its length. In another embodiment of the invention the polymeric component formed contains one or more circumferential grooves along its body to maintain the circular shape of the filter element in a reduced size artery. In one embodiment of the invention, the filter element is directly attached to a medical guidewire
airship that incorporates a sliding pod that moves to deploy the filter. In another embodiment of the invention, a device is provided that incorporates a medical guide wire with a
flexible segment of wire distal to the filter so as to provide the direction of the wire particularly before it is deployed. In another embodiment of the invention, a device is provided that incorporates a medical guidewire with a smooth distal segment to provide a tip section that will be atraumatic. In yet another embodiment of the invention, a device with a porous coating on a distal end of the filter element is provided with only one element 15 for opening and closing the filter by sliding movement. In one embodiment of the invention, the filter element incorporates proximal reduction so that it can be pulled proximally towards a sheath for removal in order that this pulling action effectively reduces the diameter
of the filter and help your recovery. In another embodiment of the invention, the filter element has a porous structure that can be unfolded and closed by slidable movement, the lock thereof being caused by way of adjustment by gripping a protruding ring that
allows the support elements to be pulled
proximally, closing the structure with the filter membrane attached. In another embodiment of the invention, there is provided a device having a filter element that allows incorporation of a medical guidewire into the external wall of the filter element to facilitate the incorporation of large inlet ports at the proximal inlet end of the filter element. filter element. In one embodiment of the invention the filter element comprises a structure of mesh work with holes large proximal inlet and holes small distal outlet wherein the mesh structure is collapsible into a delivery catheter of small diameter and can extend under deployment to the shape that is remembered by the mesh structure through the shape memory characteristics or elastic memory characteristics. In another embodiment of the invention, the filter element comprises a meshwork structure wherein the expansion of the filter element within the vessel causes the blood flowing through the vessel to flow through the filter element because the The filter element engages with the vessel wall to conform to the shape of the vessel recess. In another embodiment, the filter element comprises a braided fibrous mesh work. Preferably, the distal exit openings are defined by an area
^^^^ '^^^ "^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ ^^^^^^^^^^^^^^^^^^^^. ^^^^^^^^^ enclosed by a series of interwoven fibers cross. the holes larger proximal entry are provided by the convergence of the fibers of the braid into a few bundles which are mounted to the filter holder. 5 Preferably the material work fibrous web is a material of elastic or memory shape memory such that it can collapse into a delivery catheter and recover its enlarged shape after deployment.The fibers of the mesh work are joined at the points where they intersect with the
other. The fibers can be made either of a polymer or metal or a composite material. In another embodiment, the distal end of the filter element has the facility to move in the axial direction relative to the proximal end of the filter element so
that acquires the exact shape of the blood vessel. In another embodiment, the device has a porous coating on a distal end of the filter element with only elements for opening and closing the filter element by sliding movement. Preferably the
The filter element comprises a collapsible wire frame having a plurality of wires, outer ends of the wires are mounted hingedly on the filter holder, the wires are hinged in the middle of their ends, at one end the wires are fixed in the carrier
of the filter and on the other end the wires are mounted on
a collar which is slidable along the filter holder, a porous filter mesh that is mounted on the wire frame. The activation sleeve is slidable on the filter holder to push the collar toward the fixed end of the filter element, and a collapsing device is engageable with the collar to pull the collar back from the fixed end of the filter element to collapse the collar. wire frame against the filter holder for the recovery of the filter element. In yet another embodiment of the invention, a filter recovery system is provided for use with the device comprising a longitudinal catheter with a radially deformable or resilient tip to assist in pulling the filter back towards the tip. In another embodiment of the invention, there is provided a system incorporating a filter, a delivery catheter and a recovery catheter for temporary filtration of the vascular system during an interventional procedure. In another aspect the invention provides an embolic protection device comprising: a collapsible filter element mounted on a filter carrier for delivery through a vascular system of a patient, the filter element is movable between a stored position collapsed against the filter carrier for your
movement through the vascular system, and an expanded position to occlude a blood vessel so that blood passing through the blood vessel is delivered through the filter element, a pair of separate stops in the filter carrier, the collapsible filter element slidably mounted on the filter carrier for axial movement along the filter carrier between stops, and means for collapsing the filter element on the filter carrier. Brief Description of the Drawings The invention will be more clearly understood from the following description thereof given by way of example only with reference to the accompanying drawings in which: Figure 1 is a side view of a protective device embolic according to the invention, in use; Figure 2 is a side view of a device of Figure 1 in a pre-loaded position for insertion; - Figure 3A is a side view illustrating a method of securing the device to the catheter; Figure 3B is a side view of an embolic protection device incorporating the fixation of Figure 3A; Figure 4 is a side view illustrating another method of attachment;
Figure 5 is an end view of a split collar used in the fastener of Figure 4; Figure 6 is a side view illustrating another method of attachment; Figure 7 is an end view of a jubilee clasp used in the fastening of Figure 6; Figure 8 is a side view of a filter element used in the device of the invention; Figure 9 is a side view of another filter element; Figure 10 is a side view of the filter element of Figure 8 that is being removed; Figure 11 is an isometric view of another filter element in a configuration placed in use; Figure 12 is a side view of the filter element of Figure 11 in a retracted position for insertion and removal; Figures 13 to 15 are side views of another filter element in different positions; Figures 16 and 17 are side views of part of another filter element with a grip adjustment recovery arrangement; Figure 18 is a perspective view, partly in cross section of another embolic protection device shown mounted on a vessel;
Figures 19a to 19c are perspective views illustrating the formation of a collapsible filter holder for use in the device of Figure 18; Figures 20 to 22 are perspective views of 5 other filter elements; Figure 23 is an elevated view of another filter element; Figure 24 is a sectional view taken along line XXIV-XXIV of Figure 23; Figure 25 is a sectional view taken along line XXV-XXV of Figure 23; Figure 26 is an enlarged detail view of the filter portion; - Figure 27 is an extended view of the filter element of Figure 23; Figure 28 is a view illustrating a method in which the substrate tube where the filter element is attached can run on the primary crossover guide wire; Figure 29 is a side view illustrating the position in which the "olive" component will settle in order to provide a continuous transition between the primary crossover guide wire and the loading pod; Figure 30 is a perspective view of the filter element in its most distal position; 25 Figure 31 is a perspective view of the element
of filter in its most proximal position; Figure 32 is a perspective view of the filter element when the distal end of the filter is not attached to the substrate tube; Figure 33 is a side view of a concertina-shaped filter; where A is when the filter is deployed and B when the filter is in its loaded form; Figure 34 is a perspective view of a floating distal tip design with a spring element incorporated distal to the floating tip; Figure 35 is a side view of another floating distal tip design with a spring incorporated in the distal tip; Figure 36 is a side view of the floating distal tip design with the shape memory alloy extending from the proximal end to the distal end; Figure 37 is a perspective view of the mesh design incorporating a floating distal tip; Figure 38 illustrates perspective views of filter geometries; Figure 39 shows a fibrous mesh filter design with fibers woven at the distal end and converging in several bundles at the proximal end; Figure 40 is a partially sectioned view
elevated of an embolic protection device according to the invention; Figure 41 is a schematic sectional elevated view of the embolic protection device of Figure 40; and Figure 42 is a detailed sectional view of a portion of the device of Figure 40. Detailed Description With reference to the drawings, various embolic protection devices according to the invention are illustrated. The devices, in general, comprise a filter element for temporarily placing in a desired position during a surgical or interventional procedure, typically using a guidewire and catheter. The filter element provides a path for blood and has elements for capturing and retaining unwanted embolic material released during the surgical procedure. The filter element containing the retained embolic material is removed when the intervention procedure is completed. In this way the patient is protected against the risk of attack or other complications caused by the release of unwanted embolic material during the procedure. In one embodiment of the device, it will be used in a transcatheter configuration over the wire. The doctor will cross the injury with a steerable guidewire. The device
^^ - ^ v Jr **.
Cerebral protection will be screwed onto the guidewire and placed distal to the site of the lesion being treated. Through activation, or other elements, the filter is deployed in the vessel and will capture the emboli that are generated or discharged during balloon inflation and stent placement. The device consists of a filter attached to an arrow that can run on the primary crossing guide wire. Referring initially to Figures 1 and 2 in this case the filter element consists of a polymeric foam filter element of compressible porous structure 1 overmolded onto or attached to a polymeric or metallic tube or spring or other hollow support member 2. The foam filter element 1 is compressed in a housing or sheath 3 at a distal end of the catheter 6 to advance to the required location. Once in place the housing 3 is removed or the filter element 1 is advanced. This action allows the compressed filter element 1 to extend to the required size and occlude a blood vessel 4 with the exception of the path or paths provided through the filter element 1. The filter element 1 is designed to provide a path or multiple paths through to the blood cells and other blood constituents but to capture the emboli larger than the filter pore size. The flow velocity of the blood is maintained by the filter element of
so that a local pressure drop through the filter is minimized. The filter element 1 has a proximal inlet end 7 and a distal outlet end 8. The inlet end 7 has a plurality of centered apertures adapted to the size to allow blood in embolic material to enter the filter element. The outlet end 8 has a plurality of outlet openings adapted to the size to allow passage of blood therethrough but retain unwanted embolic material within the body of the filter element 1. The filter element 1 in this case is of a foam of porous or polymeric structure having an open cell structure with a typical density of less than 400 kilograms per cubic meter. Preferably the density will be less than 100 kilograms per cubic meter and ideally it will be less than 50 kilograms per cubic meter. The properties of the filter can be achieved by adequately adapting the pore size of the foam body or by additionally removing material to create proper size paths for blood to flow through them and means of capturing size particles. higher. Various configurations for this will be described which can customize both the size adaptation and flow rate characteristics of the filter element 1 either independently or simultaneously. The activation and deployment of the filter element 1 is achieved by providing relative movements between the filter element 1 and the cover housing 3. It is not desirable for the catheter to move relative to the support element 2 during handling. The movement can be avoided by fixing the internal support element 2 to the catheter 6 in several different ways. In the described embodiment this is achieved by having a catheter 6 cover the support element 2 and the filter element 1 to which it is fixed. As illustrated in Figures 3A and 3B the
Fixation can be achieved by means of a shrinkable wrapping tube 5 which shrinks to capture both the cover catheter 6 and the internal support element 2. As soon as the filter element 1 is in the desired position, the wrapping connection shrinking is broken using the peeling tongue
7 to allow the external catheter 6 to be removed proximally and leave the support element 2 and the filter element 1 in place. Several other workable arrangements could be used to join the support element 2 and the catheter 6.
use a split collar arrangement 10 (Figures 4 and 5) that was removable by unlocking a screw or several screws or an arrangement such as a jubilee clasp 11 (Figures 6 and 7) that could be loosened to release the joint between the components. 25 Another method that could be used to fix
temporarily the internal support element 2 to the external sheath or catheter 6 is the high-pressure Y-adapter of hemostasis Touhy Borst. This commercially available adapter is needed to allow the physician to rinse the sheath before inserting it into the artery. The external sheath or catheter can be permanently attached to this adapter. The internal tubular support element 2 runs through the Touhy Borst section of the adapter and thus through the center of the sheath. Adjusting the section of Touhy Borst is released
this grip, thereby allowing the internal tubular support member 2 and the outer sheath to move relative to each other again. The design of the filter element 1 is shown in a typical embodiment of Figure 8, wherein a filter body
of foam substrate has removable material to create a series of channels or trajectories 20 for blood to flow through but which would cause a restriction of embolic material to prevent it from going to the filter. The trajectories 20 can be machined using a variety of
methods such as laser cutting with excimer, YAG, C02, or other type of laser, freezing and machining or machining with lost wax. Several arrangements are possible with the appropriate reflection to the size of the requirements. In the configuration shown, the entrance holes are preferably 0.5
millimeters or larger in size to capture large pistons
while the external holes are less than 300 microns. This can be easily varied as required to filter particles of different sizes from a variety of fluid media in a variety of vessel sizes. The filter media can be glued to the tube substrate in the manner of a variety of available technologies such as mechanical glue, solvent or adhesive and over molding in an arrangement such that the substrate is placed in the mold and the polymer material is fired in the mold and forms a bond at the interface between the substrate and the polymer element. Additionally, the foam element or porous element could be extruded onto or stick to the substrate. It will be noted that the filter element 1 has a rounded distal end 21 to facilitate insertion and the proximal end 22 is lowered to facilitate removal. Alternatively, as illustrated in Figure 9 the distal end 23 may be decreased. Referring particularly to Figure 10 at the end of the procedure of intervention, the device can be removed by advancing a large-hole catheter 25 toward the proximal end 22 of the filter 1 and pulling the filter 1 toward the catheter 25. filter 1 will compress and seal the inlet openings of the proximal filter after the initial conical portion is stretched toward the catheter 25 before collapsing to the remainder of the filter body. As for the
* i3p- & & ¡¡¡¡¡¡¡¡¡¡St-i & M filter 1 has been completely removed towards the catheter 25 can easily be removed from the patient. Filter 1 will contain the captured pistons. In another embodiment of the invention as illustrated in Figures 11 to 15, a ray arrangement 30 covered with a porous membrane or fabric or mesh 31 can be folded into the supply sheath or sleeve for subsequent deployment in the target vessel. The design consists of a substrate arrow 33 on which are attached radially or circumferentially a series of preformed wires 30. The wires 30 are attached to the proximal end in a movable collar or tube 32 mounted on the substrate arrow 33 and at the end distal in a fixed tube 34. The tube 32 can be moved proximally and distally to the extent that it will open and close the assembly in a manner similar to an umbrella and thereby occlude the vessel. The spokes 30 can be manufactured in a range of metallic, polymeric and composite materials. The frame is covered with a porous material 31, whose pore size is selected to allow the medium through which a filter is effectively created. The cover fabric 31 could be attached to the frame 30 by means of emptying a material such as polyurethane or PET onto the preformed form. The film can be relaxed or made porous by other means such as mechanical or heat perforation or chemical corrosion. Additionally, incorporate a soluble particle in the matrix
a »^ A¿- * .; .. -, - ". -. . á @jf B¡g¿é í5te ¿. ¡.Z ~? I £ x £ ^. < * & amp; amp; amp; amp; amp; amp; amp; amp; amp; amp; amp; of polymer, subsequent removal of the particle would result in porous polymer. The porosity control is achieved by customizing the proportion and distribution of the particles within the polymer matrix. 5 When the assembly is configured longitudinally a sleeve or sleeve can be slid over it to cover it. As with the previous modality, the loaded catheter is placed in the required place by screwing it over the guidewire. Once the desired location has been reached, the pod can be moved
back and allow the assembly to be exposed in the cup. A sleeve 35 can then be moved forward to open or unfold the assembly. The relative sizes and choice of materials operates so that sleeve 35 will not slip into the inner tube unless an external force is applied
to move it. When deployed, the device will remain open and will trap any embolic material that moves into the brain. At the end of the procedure, a preformed component will advance on the inner tube to be embedded with the movable tube 32 and allow it to slide towards the end
proximal of the device with the result that the structure closes. A larger pod can be advanced separately to the filter site and the filter can be pulled or manipulated towards it. When removed to the sheath or catheter the device can be removed either on the
guide wire or with it.
Referring to Figures 16 and 17, another embolic protection device is illustrated. In this case the filter element has a design based on a thin film component formed stuck on the tube substrate. A large number of ways could be made to work on the application. An element which through its preformed shape will open towards the structure 40 when the restraining force is removed, joins the tube substrate 41. The frame member 40 can be manufactured from a range of
metal or polymeric components such as a shape memory alloy such as Nitinol or a shape memory polymer or a formed stainless steel or metal with similar properties that will recover from deformation sufficiently to cause the film component to open. Of other
a mechanical movement or activation may cause the device to open. The formed film component is bonded onto the frame 40. The film component can be formed by various known commercial technologies. These include blow molding, pouring, pouring solution,
casting by rotation and film welding as well as adhesive bonding. The object is to produce a shaped form that can be opened in the vessel to a size and shape to occlude it. Filtration is achieved by creating a pattern or series of openings in the proximal and distal ends of the element that allows the
emboli and blood enter the device but it has a
range of smaller openings at the distal end to allow blood to pass through the distal vasculature while retaining the emboli. Although supplied to the required site, the filter element is covered or restricted by a sheath. By removing the sheath or advancing the filter device, the filter is discovered and opened to occlude the vessel. During the procedure, the filter acts to capture all the embolic material that attempts to flow distally. At the end of the procedure, a sheath is advanced to the proximal end of the device and the filter is pushed proximally towards it with the retained pistons captured. In this design configuration, the emboli can easily be removed for analysis after this. The above invention is described in relation to a device that can be used on a medical guidewire. There is the opportunity to configure the invention so that by itself it could be used as a primary crossing device. All of the filter designs described above could be mounted on either the wire or the primary crossover device as described hereinafter. For a primary crossing device the filter would be stuck to a solid substrate. Some benefits would be gained because the internal diameter over which the filter could be wrapped would be smaller because it would not need to move on another instrument. Figure 18 illustrates the differences involved. The filter element 1 is mounted on the substrate arrow 33. A collapsible filter support element 50 is mounted on the substrate arrow 33 at a proximal end of the filter 1. The support member 50 has several foldable arms 51 that are they collapse against the arrow 33 for deployment after release, extending outward to extend the filter l into the vessel. Referring to Figures 20 to 22 alternative constructions of the filter element are shown comprising a compressible filter 1 shown in an extended position with a large inlet opening 60 and small outlet openings 61. A collapsible wire support 62 is provided in a proximal end of the filter 1. The wire support 62 is collapsible with the filter 1 within a housing or sheath for deployment and after the release expands to support the filter 1 in the vessel 4. An alternative filter arrangement is shows in the
Figures 23 to 27. In this case, the filter comprises a Nitinol mesh in which it is extendable from a collapsed position shown in Figure 23 for deployment to an extended position in use shown in Figure 27 to provide a body filter 65 with proximal input 66 and distal outputs 67. For a primary crossover device, the end
^ S ** - * ** ^ ... - "~ t * £ &t & S * il i £ *. ". I. »~ ^^? £ ^ »? ^ ^ E, - '^ A > J? E ^^ distal device will be flexible and atraumatic. This can be achieved by various means such as manufacturing a spring or polymeric element that is flexible enough to bend when placed in contact with the vessel walls. 5 The tip section would be mounted distally to the filter element. An intermediate section of the device will house filter 1 which would be covered before deployment. A pod could have the total length of the device or be attached by an activator to a shorter sheath that covers nothing more than the
filter. The proximal section of the device will provide a platform for balloon dilation and stent devices. The provision of a platform can be achieved as shown by removing the proximal cover to expose a wire or spring assembly. Alternatively, the section
complete proximal would function as the platform. Essentially, to function as the platform for the balloon and stent catheter, the devices should be made the size with an external diameter dimension that allows free movement of the catheter system thereon. The
typical industrial standards for coronary products allow free movement of devices over a diameter of 0.035 centimeters (0.014 inches) or 0.045 centimeters (0.018 inches) while applications of peripheral angioplasty use an external diameter of .088 centimeters (0.035)
inches).
Referring to Figure 28 the tube substrate 33 on which the filter element is attached can be moved between two detents 63 and 64, the detents are mounted on the crossing guide wire 2. The arrests can be fabricated from a range of metallic or polymeric components, which will allow the movement of the tube substrate 33 between them. The arrests may be in the form of a step on the actual medical guide wire. A large variation in distances between detentions 63 and 64 could be made for
that will work in this application. The arrests are made in size to prevent movement of the tube substrate either above or below them so that they act as a stopping position for the tube substrate at both the proximal and distal locations. The arrests can be mounted
over the primary crossover guide wire by various known commercial technologies; These include soft solder, hard solder, simmer, flange and adhesive bond. The proximal stop would be small enough in size to fit the inner arrow of the catheter
supply. The filter element can be moved axially and rotatably independently of the guide wire. This allows good wire movement and control of filter position. The position of the filter will be maintained during the catheter exchange. Any available guide wire
known can be adapted accordingly and used with this technique.
S ^^ MÁ ^, ^. ^^^ & ^^ & - ^^ ,. ?,. ^^ 2 ^., ...,. ^ I * a.fi * g ^ | ÉÉi ** g ^^ Figure 29 refers to an "olive" 65; The olive component can be manufactured from a range of metallic or polymeric components such as foams, plastics, polymer, stainless steel or metal. The olive will allow a smooth transition between the guide wire 2 and the sheath 3 in which the filter element is loaded and also allows easy placement of the filter element within the sheath. The olive can be attached directly to the guide wire or it can also attaching to the tube substrate 33. The olive can be attached to guide wire or tube substrate by a range of known techniques such as adhesive bonding and welding. The olive will work as required for a range of distances distal to the filter element. A large number of shapes and sizes could be made to work as an olive component. Figure 30 refers to the filter element 1 when placed in its most distal position. The filter element can achieve this position during loading or after deployment. The stop element 64 prevents the filter element 1 from moving further in the distal direction. Figure 31 illustrates the filter element in its most proximal location. The filter element can achieve this position when deploying the device after deployment. The stop element 63 prevents the filter element 1 from moving beyond it in the proximal direction.
--JL ** & ££ k¿ *? & £ * - '- «to gjfeft Figure 32 refers to a distal float tip in this case a stop component 66 is positioned proximal to the distal end of the filter. The most distal end of the filter is fixed to a marker band 70 or other convenient substrate. The marking band 70 is not fixed to the pipe of the substrate 33. This allows the distal end of the filter to have freedom of movement in the axial direction beyond the stop component. The stopping component can be worked using any configuration or shape to prevent movement of the distal end of the filter in the proximal direction beyond the attachment point of the stopping component. The stop component can be fabricated from metals or polymeric material, can be attached to tube substrate 33 by various existing technologies including adhesive bonding and welding. The stop component 66 will work when placed anywhere between 50 and 70. A distal float tip of the filter element will facilitate loading of the filter element into the loading pod since the filter can now be extended in the axial direction and therefore wrapping down over a greater length. This will reduce the load force required and also reduce the profile of the load filter. The design of the distal float tip will facilitate the loading of a large range of filter designs. Figure 33 refers to a concertina-shaped filter with a distal float tip. This filter geometry adds circumferential integrity of the filter and thus prevents the formation of folds along the length of the filter. "A" illustrates the filter as it would be when in position. "B" illustrates how the distal tip will extend in the axial direction when the filter element is loaded into the loading sheath. The design of the tip of flotation can be used to accommodate the load of many designs of filter forms. For the filter design shown, a longer sheath is needed to accommodate the increase in axial length of the filter element when it is loaded. Figure 34 refers to the design of the distal float tip with a spring element 67 incorporated in the design. The spring is placed distal to the filter element. As previously illustrated in Figure 33, the distal float tip extends in the axial direction when loaded, the spring acts as a safety device when the filter is deployed and ensures the return of the distal float tip to its primary location . The spring element will be soft enough to allow the distal tip to extend freely in the distal direction during loading but sufficiently rigid to push the distal tip back to its primary location after deployment. The spring element can be made of either a polymer component or a metal component. The spring element can be mounted on a substrate 33 and a stop component used to prevent the
axial movement of the spring in the distal direction. Other methods of holding the distal end of the stationary spring element could be used such as gluing, welding, flanging, soldering or flanging the distal end of the spring on the substrate 33. This technique could also be done to work with the spring that is part of the spring. of the real guide wire. There are many other configurations by which a spring element can be incorporated back into the filter as shown in Figure 35 and 36. In Figure 35 the spring element 67 is glued to the substrate 33 at its proximal end and the end distal of the filter element is attached to the spring arrow. This design allows the distal end of the filter element to extend in the distal direction. The extension length could be determined either by placing a stop 68 or by spring stiffness. When external forces are removed from the filter the spring will return to the filter to its primary place. In Figure 36 a shape memory alloy such as nitinol is used to return the filter to its primary location. The nitinol support frame 69 is fixed to the substrate 33 at its proximal end 70 and is floating at the distal end 71. The shape memory properties of the nitinol will ensure that the filter element returns to its primary location. This design can facilitate the use of any other known or commercially available shape memory alloys. This design could also be made to work using a spring component. Figure 37 again incorporates a distal float tip design. The filter body 65 as illustrated previously in Figure 27 is mounted on a substrate 33. At the proximal end the stent is fixed to the substrate. The distal float tip design allows the filter body 65 to extend in the distal direction. As the filter body 65 extends there is a reduction in its external diameter and an increase in its overall length. There may or may not be a need for a stop 68 as the filter body 65 will extend towards its own elastic limit which is determined by its size and geometry. The shape memory function of the filter body 65 will cause the distal tip 15 to return to its primary location when external forces are removed from it. The proximal end of the filter body 65 can be fixed to the substrate by several known technologies such as gluing, welding or flanging. Figure 38 illustrates several different filter designs 20 that could be made to work as embolic protection devices. All these filter designs work to reduce the longitudinal length of folds that can occur if the filter is of a larger size, thereby acting as a pleat breaker. 25 Either end of the filters shown would act
--- fe-terrig &S ^^ ^ ^ ^ ¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡^ ^^^ ¿^^^ ^^ ^^^^^^^ ^^^^^^^^^^^ well as proximal and distal ends of the filter. the filter body may be tubular or frustoconical. referring to Figures 40 to 42 embolic protection device according to the invention generally indicated by reference numeral 100. the device 100 has a guide wire 101 with a proximal end 102 and a distal end 103. a tubular sleeve 104 slidably mounted on the wire illustrated guide 101. A collapsible filter 105 is mounted on sleeve 104, filter 105 being movable between a stored collapsed position against sleeve 104 and an extended position as shown in the drawings extended outwardly from sleeve 104 for deployment in a The sleeve 104 is slidable on the guide wire 101 between a pair of separate extreme stops, namely an internal stop 106 and a external arrest which in this case is formed by a spring tip 107 at the distal end 103 of the guide wire 101. The filter 105 comprises a mesh network 110 mounted on a collapsible support frame 111. The mesh network 110 meets in the sleeve 104 at each end, the net 110 is rigidly attached to a proximal end 112 of the sleeve 104 and the net 110 is joined by a collar 115 that is slidable along the distal end 114 of the sleeve 104. Of this mode the distal end of the network 110 is longitudinally slidable to
along the sleeve 104. The support frame 111 is also fixed on the proximal end 112 of the sleeve 104. A distal end 116 of the support frame 111 is not attached to the sleeve 104 and thus is also free to move. longitudinally along the sleeve 104 to facilitate collapsing the support frame 111 against the sleeve 104. the support frame 111 is such that is naturally expanded as shown in the drawings and can be collapsed inwardly against the sleeve 104 for loading in catheter 118 or something similar. The filter 105 has large proximal inlet openings 117 and small distal outlet openings 119. The proximal inlet openings 117 allow blood and embolic material enter the filter body to, however, the distal outlet openings 119 allow the passage of blood through them but retain the unwanted embolic material inside the body of the filter. An olive guide 120 is mounted on the distal end of the sleeve 104 and has a cylindrical central portion 121 with tapered ends 122, 123. The distal end 122 can be an arrowhead configuration for smooth transition between the catheter and the surface of the olive. The support frame 111 is shaped to provide a circumferential groove 125 in the filter net 110. If the filter is too large for a vessel, the net can be folded and this groove 125 ensures any crease does not propagate to
&% -xá - "" '- "^ - B *** ^ * - length of the filter The enlarged openings are provided at a proximal end of the filter network 110 to allow the entry of blood and embolic material into the Inside the network 110. In use, the filter 105 is mounted in a collapsed state within a distal end of the catheter 118 and a deployment site is provided.When the filter is correctly positioned the catheter 118 retracts allowing the frame to lll support extends inflating the network 110 through the vessel in which the filter is mounted. blood and emboli can enter the enlarged openings at the proximal end of the net 110. the blood will pass through the wall of the However, the openings or pores in the network are suitable for the size to retain the embolic material After use the catheter is supplied along the guidewire 101 and slides on the filter 105 engaging the proximal inlet end 112 before to close the a creases and gradually collapsing the network against the sleeve 104 as the catheter 118 advances over the filter 105. As soon as the filter 105 is fully loaded in the catheter 118, it can then be removed. It will be noted that a proximal end of the filter is fixed and a distal end of the filter is longitudinally movable along the sleeve to facilitate collapsing the filter net.
In addition, the catheter engages the proximal end of the filter net first thus closing the inlet of the filter net and preventing the escape of embolic material from the filter network as the filter network collapses. Conveniently the tip of the catheter forming a housing or sheath for receiving the filter is of an elastic material that can be radially extended to accommodate the filter with the embolic material captured. By choosing the correct material, the same catheter or sheath can be used to deploy and recover the filter. For deployment, the elastic material holds the filter in a tightly collapsed position to minimize the size of the catheter tip or sheath. Then, when the filter is removed, the catheter tip or sheath is sufficiently elastic to accommodate the extra volume of the filter due to the embolic material. Also, the filter is not fast in the guide wire and thus the accidental movement of the guidewire is accommodated without inadvertently moving the filter, for example, during the exchange of medical devices or when changing catheters. It will also be noted that the filter according to the invention does not have a sharp outer edge as with many umbrella-type filters. Instead, the generally tubular shaped filter is better suited to the inner walls of the blood vessels. Also conveniently when the filter has been deployed in a blood vessel, the catheter can be removed by leaving a bare guide wire next to the filter for use with known devices such as a balloon catheter and stent devices upstream of the filter.
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Claims (105)
1. A vascular filter device for removing embolic material in body fluid, the device comprising: a delivery system having a longitudinal axis, distal and proximal portions, the distal portion of the delivery system being removably advanced towards a patient's vasculature; a collapsible filter body having a longitudinal axis, proximal and distal ends and further having a collapsed configuration and an extended deployed configuration, the collapsed configuration permitting supply and removal of the filter body from the vasculature of a patient; the filter body defining an interior space when in the extended configuration; at least one fluid inlet at the proximal end of the filter body, the inlet being open to admit blood and embolic material into the interior space when the filter body is in extended configuration, and substantially closed to the fluid flow when the body of filter is in collapsed configuration; a plurality of outlet openings in the distal end of the filter body, the outlet openings being open to the flow of fluid from the interior space when the filter body is in the extended configuration; the outer openings are suitable for size to allow passage of blood through them but retain the unwanted embolic material within the filter body; wherein the filter body moves between the collapsed and extended configurations through the relative movement of the filter supply system with respect to the filter body; and the proximal end of the filter body is collapsible in transition to the collapsed configuration whereby it first substantially closes the at least one filter inlet to ensure retention of any embolic material collected in the interior space and then to collapse the remainder of the body of the filter. filter.
2. A device as claimed in claim 1 wherein the proximal end of the filter body is collapsible before collapsing the distal end of the filter body during the transition between extended configurations and removal.
A device as claimed in claim 1 or 2 wherein the delivery system comprises a tubular member, the filter body being moved between the collapsed and extended configurations through relative movement of the tubular member with respect to the filter body .
4. A device as claimed in claim 1 or 2 wherein the delivery system comprises a guide wire, the filter body is moved to 5 through a relative movement of the guide wire with respect to the filter body.
5. A device as claimed in claim 4 wherein the guidewire is a solid guidewire.
6. A compliant device is claimed in any preceding claim wherein the filter body has a generally tubular shape.
7. A conforming device is claimed in any previous claim wherein the proximal end of the body Filter 15 is decreased outwardly and distally when in the extended configuration.
8. A compliant device is claimed in any of the preceding claims wherein the distal end of the filter body is lowered outwards and 20 proximally.
9. A compliant device is claimed in any preceding claim wherein the filter body has a generally cylindrical portion between the proximal and distal ends. 25
10. A compliant device is claimed in any previous claim wherein the filter body has a smooth distal portion to aid in atraumatic transport through the vascular system.
11. A compliant device is claimed in any preceding claim, wherein the filter body is defined by a generally elongated shape having an axial dimension greater than the transverse dimension when in an extended configuration.
12. A compliant device is claimed in any of the preceding claims wherein the filter body has a generally circular cross section and an associated circumference, and at least one slot arranged around the associated circumference.
13. A compliant device is claimed in any preceding claim wherein the outlet holes of the filter body are sized to capture embolic material larger than 100 microns in size.
14. A device as claimed in claim 13 wherein the outlet orifices of the filter body are sized to capture embolic material larger than 200 microns in size.
15. A device as claimed in claim 14 wherein the outlet orifices of the filter body are sized to capture embolic material larger than 500 microns.
16. A compliant device is claimed in any preceding claim wherein the exit openings are generally circular.
17. A device as claimed in any preceding claim wherein the delivery system comprises a tubular filter recovery device having a distal end open for receiving the filter body in the collapsed configuration, the open distal end of the device filter recovery is engageable with the proximal end of the filter body whereby the at least one fluid inlet is substantially closed and is slidable relative to the filter body whereby the rest of the filter body progressively collapses and the filter body is received inside the recovery device.
18. A compliant device is claimed in any of the preceding claims wherein the delivery system further comprises a storage portion for the filter body when the filter body is in the collapsed configuration.
19. A device as claimed in claim 18 wherein the storage portion further comprises an open distal end arranged so that the proximal end of the filter body is hooked to the open distal end during the transition of the filter body of the filter body. ÍU gj g the extended configuration towards the collapsed withdrawal configuration.
20. A conforming device is claimed in any previous claim wherein the supply system 5 comprises a delivery catheter, wherein one end of the delivery catheter comprises a storage portion.
21. A conforming device is claimed in any preceding claim which further comprises a recovery catheter, wherein one end of the recovery catheter 10 comprises a storage portion.
22. A compliant device is claimed in any of claims 18 to 21 wherein the storage portion is a pod.
23. A compliant device is claimed in claim 22 wherein the sheath is extendable to accommodate the filter in the collapsed withdrawal configuration.
24. A compliant device is claimed in any of claims 4 to 23 wherein the filter body is slidably disposed in the guidewire.
25. A device as claimed in claim 24 further comprising at least one stop for limiting the range of a longitudinal movement of the filter body on the guide wire.
26. A conforming device is claimed in the 25 claim 25 wherein at least one of at least one Detention is located inside the interior space when, in use, the filter body is in extended deployed configuration.
27. A compliant device is claimed in claim 25 or 26 wherein at least one stop is mounted on the guide wire.
28. A compliant device is claimed in any of claims 25 to 28 wherein the at least one stop is metallic.
29. A compliant device is claimed in any of claims 25 to 28 wherein the at least one stop is polymeric.
30. A compliant device is claimed in any of claims 25 to 28 wherein the at least one stop is formed as a step in the guide wire.
31. A compliant device is claimed in any of claims 25 to 28 wherein the at least one stop is adapted to the shape to conform to the internal diameter of a delivery catheter.
32. A compliant device is claimed in any of claims 25 to 31 wherein the filter body comprises a sleeve member slidably disposed on the guide wire.
33. A compliant device is claimed in claim 32 wherein the at least one stop includes at least one first and one second detention, wherein the length of the sleeve member is less than the distance between the stops, the filter body being mounted on the sleeve member.
34. A compliant device is claimed in claim 32 or 33 wherein the proximal inlet end of the filter body is fixed to the sleeve member and the distal end of the filter body is slidably mounted on the sleeve member.
35. A compliant device is claimed in any of claims 32 to 34 wherein the distal end of the filter body is attached to a collar that is slidable along the sleeve member.
36. A compliant device is claimed in any of claims 32 to 35 wherein the sleeve member further comprises an olive guide distal to the filter body and decreasing distally and inwardly.
37. A compliant device is claimed in claim 36 wherein the guide olive is provided in the filter holder distally of the filter body, the guide olive has a cylindrical body with a distal end decreased, the cylindrical body being engaged within the end distal of a deployment catheter, the distal distal end projects out of the deployment catheter to provide a smooth transition between the catheter and the catheter. E * ^. 1- ** -Z..Í carrier of the filter.
38. A compliant device is claimed in any preceding claim wherein the filter body is rotatable in relation to the delivery system. 5
39. A compliant device is claimed in any preceding claim wherein the filter body comprises a filter frame, the frame is movable between a collapsed position wherein the filter body is in collapsed configuration and an extended outward projection position. 10 in the extended deployed configuration.
40. A compliant device is claimed in claim 39 wherein the filter body is mounted in a filter carrying sleeve and the frame is fixed in a sleeve at the proximal end of the filter body.
41. A compliant device is claimed in claim 40 wherein the frame is slidably engaged with the sleeve at the distal end of the filter body.
42. A compliant device is claimed in any of claims 39 to 41 wherein the frame deviates 20 to a normally extended position.
43. A compliant device is claimed in any of claims 39 to 42 wherein the frame comprises support arms.
44. A compliant device is claimed in any one of claims 39 to 43 wherein the frame includes a plurality of collapsible arms having proximal and distal end, the arms extend outwardly and distally from the proximal end of the filter body to define the decrease of the proximal end of the filter body
45. A device as claimed in any of the claims 39 to 44 where the frame is formed of any material with shape memory or elastic memory.
46. A compliant device is claimed in claim 45 wherein the frame is Nitinol.
47. A compliant device is claimed in any of claims 43 to 46 wherein the entry openings are at least partially defined by the arms.
48. A compliant device is claimed in any of claims 44 to 46 wherein the proximal ends of the arms extend substantially radially outward in a direction distal to the longitudinal axis of the filter body.
49. A compliant device is claimed in claim 48 wherein the distal ends of the arms extend substantially radially outward in a direction proximal to the longitudinal axis of the filter body.
50. A compliant device is claimed in any preceding claim wherein the filter body is formed of a mesh material.
51. A conforming device is claimed in either §g ^ ¡££ irfteaiiáaift '. jj r of claims 1 to 49 wherein the filter body is formed of a woven material.
52. A compliant device is claimed in any of claims 1 to 49 wherein the filter body 5 is formed of a perforated film material.
53. A compliant device is claimed in any of claims 1 to 49 wherein the filter body is formed of a material having a porous structure.
54. A compliant device is claimed in any one of claims 1 to 49 or 53 wherein the filter body is formed of a polymeric foam material.
55. A compliant device is claimed in any previous claim wherein the filter body includes storage elements for storing embolic material 15 unwanted captured in the filter body.
56. A compliant device is claimed in claim 55 wherein the storage element comprises additional storage paths within the filter body.
57. A compliant device is claimed in any preceding claim wherein the filter body defines a three-dimensional matrix.
58. A compliant device is claimed in claim 57 wherein the filter body is of a 25 polymeric porous structure.
59. A compliant device is claimed in any of claims 52 to 58 wherein the material has a density of less than 400 kilograms per cubic meter.
60. A compliant device is claimed in any one of claims 52 to 59 wherein the material has a density of less than 100 kilograms per cubic meter.
61. A compliant device is claimed in any of claims 52 to 60 wherein the material has a density of less than 50 kilograms per cubic meter.
62. A compliant device is claimed in any preceding claim wherein the filter body comprises a porous structure sized to trap embolic material ranging in size from 100 microns to 3500 microns.
63. A compliant device is claimed in any preceding claim wherein the filter body is compressible and / or bendable for loading into a supply device for supplying the filter body to a desired location in the compressed or bent state.
64. A compliant device is claimed in any previous claim wherein the filter body has material removed from its structure to aid compression.
65. A compliant device is claimed in any previous claim wherein the filter body has material removed from its structure to provide size 25 specific in relation to the size of embolic material that ^^^^^^^^^^^^^^^^^^^ ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ ^^^^^^^^^^^^^^^^^^^^^ ^^^^ going to catch.
66. A compliant device is claimed in any preceding claim wherein the filter body has paths through the filter body that are interlaced with each other. 5 way that the flow rate through the filter can be customized.
67. A compliant device is claimed in any preceding claim having means for positioning the device on a medical guidewire.
68. A conformal device is claimed in claim 67 which can be placed under a balloon or stent delivery catheter.
69. A conforming device is claimed in any previous claim that has means to insert through 15 of femoral, brachial, radial, subclavian or other artery through a transcatheter approach.
70. A conforming device is claimed in any preceding claim wherein the delivery system comprises a delivery catheter in which an external sheath 20 is chained to the filter body or filter carrier to provide thrust during delivery and is removable to allow maximum space in the vascular cross section during an intervention procedure.
71. A compliant device is claimed in claim 70 wherein the outer sheath is attached to the body of filter or filter carrier by joining means.
72. A compliant device is claimed in claim 71 wherein the attachment means is a removable shrunk tube. 5
73. A compliant device is claimed in claim 71 wherein the attachment element is a removable split collar.
74. A compliant device is claimed in claim 71 wherein the attachment element is a snap 10 removable.
75. A compliant device is claimed in claim 71 wherein the attachment means is a compression connector.
76. A compliant device is claimed in claim 75 wherein the compression connector is a Tuohy Borst adapter.
77. A compliant device is claimed in any of claims 70 to 76 wherein the delivery catheter has a central lumen in at least part of its 20 length to allow a steerable guide wire to be dragged.
78. A compliant device is claimed in any of claims 70 to 77 wherein the outer sheath is long enough to extend to the outside of the 25 vasculature and is removable proximally to release the body of catheter filter.
79. A device as claimed in any of claims 70 to 78 wherein the delivery catheter has an external covering which extends beyond the push element to define a filter retention sleeve.
80. A device as claimed in any preceding claim wherein the delivery system comprises a delivery catheter having a spring component with a stepwise increasing pitch to alter localized stiffness characteristics to suit the target vasculature.
81. A compliant device is claimed in any preceding claim wherein the delivery system comprises a delivery catheter having a spring component with a step increasing gradually located to alter the stiffness characteristics to suit the target vasculature.
82. A compliant device is claimed in any preceding claim wherein the filter body is mounted in a collapsible support frame which is movable between a collapsed position for deployment and an extended position in use, means being provided to retain the structure of support in the collapsed position.
83. A compliant device is claimed in any £ ¿¿S & # & Mtéfo -% flf - a-ae *. J ^ ^ ^ Yes? i ^^^^ ^ XA ^^ - ^ ^^^^^^ preceding claim wherein the filter body has a support structure associated with a preformed spiral arrangement so provides radial support to the filter body.
84. A compliant device is claimed in any preceding claim wherein the filter body comprises a polymer component in a flexible form.
85. A compliant device is claimed in claim 84 wherein the polymeric component formed is 10 constructs so that fluid flows through the component and aids in openings of the component of the collapsed position.
86. A compliant device is claimed in any of claims 84 or 85 wherein the polymeric component formed is flexible and opens to make contact 15 tubular with the vessel wall so as to use a pressure drop across the outlet filter face.
87. A compliant device is claimed in any preceding claim wherein the filter element directly attaches to the steerable medical guidewire 20 incorporating a sliding pod that moves to deploy the filter.
88. A device as claimed in any preceding claim incorporating a medical guidewire with a flexible segment of wire distal to the filter so that 25 provides wire steerableness particularly before be deployed.
89. A compliant device is claimed in any preceding claim that incorporates a medical guide wire with a soft distal segment to provide a section of 5 tip that will be atraumatic.
90. A device as claimed in any preceding claim having a filter body which allows the incorporation of a medical guidewire in or near the outer wall of the filter body to facilitate 10 incorporation of large inlet holes in the proximal inlet end of the filter body.
91. A compliant device is claimed in any preceding claim wherein the filter body comprises a mesh work structure with inlet holes 15 proximal large and small distal exit holes where the mesh structure is collapsible in a small diameter, expandable delivery catheter over the deployment to a shape that is remembered by the mesh structure either through memory features in a way or through 20 of elastic memory characteristics.
92. A device as claimed in any preceding claim wherein the filter body comprises a mesh work structure wherein the expansion of the filter body within the vessel causes blood to flow 25 through the vessel flow through the filter body due to ^ j ^ £ i ^^ | £ g ^ g that the filter body engages with the vessel wall to conform to the shape of the vessel recess.
93. A compliant device is claimed in any preceding claim wherein the filter body comprises 5 a braided fibrous mesh work.
94. A compliant device is claimed in claim 93 wherein the distal outlet openings are defined by an area enclosed by a series of interwoven cross fibers.
95. A compliant device is claimed in any of claims 93 or 94 wherein the larger proximal inlet orifices are provided by the convergence of braid fibers in some bundles that are mounted in the delivery system.
96. A compliant device is claimed in any of claims 93 to 95 wherein the fibrous mesh work material is a material with elastic memory or shaped so that it can collapse in a delivery catheter and recover its enlarged form. after the deployment.
97. A compliant device is claimed in any of claims 93 to 96 wherein the fibers of the meshwork are attached to the points where they intersect each other.
98. A compliant device is claimed in any of claims 93 to 97 wherein the fibers are already made 25 either from a metal polymer or a compound. **** --.- ^ S * Xk *** i *, .- > < ~ * s¡á? u í * W * ¡~ ** ¡* * > .. ^ .....
99. A compliant device is claimed in any preceding claim wherein the distal end of the filter element has the facility to move in the axial direction relative to the proximal end of the filter body so as to collect the exact shape of the blood vessel.
100. A compliant device is claimed in any preceding claim with a porous coating on a distal end of the filter body only with means for opening and closing the filter body by slidable movement.
101. A compliant device is claimed in claim 100 wherein the filter body comprises a collapsible wire frame having a plurality of wires, external ends of wires that are hingedly mounted in a supply system, the wires being articulated in the middle. from its ends, and at one end the wires are fixed in the supply system and at the other end the wires are mounted on a collar slidable along the supply system, a porous filter mesh is mounted on the wire frame .
102. A compliant device is claimed in claim 101 wherein an activation sleeve is slidable over the delivery system for pushing the collar towards the fixed end of the filter body, and a collapsing device is engageable with the pull-down collar. new the collar away from the fixed end of the filter body to collapse the wire frame against the supply system for the recovery of the filter body.
103. A retrieval system for use with the device as claimed in any of the preceding claims comprising a longitudinal catheter with a deformable tip to help pull the filter body back toward it.
104. A method for capturing and removing embolic material from a blood vessel during an interventional procedure comprising the steps of: preparing an embolic protection device comprising a guidewire having a proximal end and a distal end, a filter body collapsible mounted adjacent the distal end of the guide wire, the filter body is movable between a stored collapsed position against the guide wire and an extended position extending laterally outwardly of the guidewire; sliding a catheter along the guidewire and over the filter body from a proximal inlet end of the filter to collapse and accommodate the filter at a distal end of the catheter; inserting the distal end of the catheter into the patient's vascular system; place the distal end in a desired location I4 of the blood vessel; holding the guide wire and retracting the catheter to release the catheter filter body in the extended position; filter blood in the vessel during the intervention procedure; after the intervention procedure advance a recovery catheter along the guide wire, to engage a proximal inlet end of the filter; collapsing the filter at the distal end of the catheter; and removing the patient's catheter.
105. A method for introducing a filter into the vasculature of a patient to capture embolic material released during an intravascular procedure, comprising the steps of: providing a delivery system having a longitudinal axis, distal and proximal portions, having the distal portion a storage portion; providing a collapsible filter body in the storage portion, the filter body having: a longitudinal axis, proximal and distal ends; a first collapsed supply configuration, a second extended deployment configuration, and a third collapsed withdrawal configuration; ^ Hgjg ^ • ^ fefLßu & aiH ^ á an interior space when in the second extended configuration; at least one fluid inlet at the proximal end of the filter body; a plurality of outlet openings at the distal end of the filter body; introducing the storage portion of the delivery system into the vasculature of a patient at a desired location; moving the filter body from the storage portion to the vasculature; moving the supply system for transition of the filter body from the first collapsed configuration to the second extended configuration from the distal end of the filter body towards the proximal end, opening therewith the entry to admit body fluid into the interior space during the transition from the proximal end of the filter body to the second extended configuration; filtering emboli from the body fluid that pass through the interior space of the filter body; moving the delivery system to the transition of the filter body from the second extended configuration to the third configuration collapsed from the proximal end of the filter body to the distal end to capture the emboli in the filter body, closing by . "3l" k *. & í¿ £? í? Mg. ^^ ggjgS? ^ '^ this the entry during the transition from the proximal end of the filter body to the third collapsed configuration; and removing the filter body and captured emboli from the patient's vasculature. - # -. = ^ liÉii ^ a ^^^^^^^^^^^^^ = ^^^^^^^^ -,; .. v - • -? -; ^^ liÍwiií MHtf1? J '"" ^ f ^ t ^ rH ^^^^ H ^^^
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IE970789 | 1997-11-07 | ||
| IE980267 | 1998-04-08 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MXPA00004382A true MXPA00004382A (en) | 2001-12-04 |
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