WO2005091813A2 - Filter media and methods of manufacture - Google Patents
Filter media and methods of manufacture Download PDFInfo
- Publication number
- WO2005091813A2 WO2005091813A2 PCT/US2005/004722 US2005004722W WO2005091813A2 WO 2005091813 A2 WO2005091813 A2 WO 2005091813A2 US 2005004722 W US2005004722 W US 2005004722W WO 2005091813 A2 WO2005091813 A2 WO 2005091813A2
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- WIPO (PCT)
- Prior art keywords
- filter
- section
- edge
- recited
- filter material
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2/012—Multiple filtering units
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00526—Methods of manufacturing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2002/018—Filters implantable into blood vessels made from tubes or sheets of material, e.g. by etching or laser-cutting
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0004—Rounded shapes, e.g. with rounded corners
- A61F2230/0006—Rounded shapes, e.g. with rounded corners circular
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/005—Rosette-shaped, e.g. star-shaped
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0073—Quadric-shaped
- A61F2230/008—Quadric-shaped paraboloidal
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0023—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity
Definitions
- the present invention relates to embolic protection devices. More particularly, the present invention relates to filters and methods of manufacturing the filters.
- a catheter is inserted into a narrowed artery to remove the matter occluding or narrowing the artery, i.e., fatty material.
- the catheter includes a rotating blade or cutter disposed in the tip thereof. Also located at the tip are an aperture and a balloon disposed on the opposite side of the catheter tip from the aperture. As the tip is placed in close proximity to the fatty material, the balloon is inflated to force the aperture into contact with the fatty material. When the blade is rotated, portions of the fatty material are shaved off and retained within the interior lumen of the catheter. This process is repeated until a sufficient amount of fatty material is removed and substantially normal blood flow is resumed.
- stenosis within arteries and other blood vessels is treated by permanently or temporarily introducing a stent into the stenosed region to open the lumen of the vessel.
- the stent typically includes a substantially cylindrical tube or mesh sleeve made from such materials as stainless steel or nitinol.
- the design of the material permits the diameter of the stent to be radially expanded, while still providing sufficient rigidity such that the stent maintains its shape once it has been enlarged to a desired size.
- percutaneous interventional procedures i.e., angioplasty, atherectomy, and stenting, often dislodge material from the vessel walls.
- the filter includes a filter material which includes pores or openings to allow the blood to pass therethrough while at the same time preventing larger debris from passing therethrough.
- the filter material is constructed from an organic or inorganic polymer.
- Suitable polymeric materials can be formed into a thin film using a variety of techniques such as extrusion, dip molding, stretching, casting, and calendering.
- Polymer films can be constructed quite thinly, usually having wall thicknesses of about 1 mil (25 ⁇ m).
- wall thicknesses usually having wall thicknesses of about 1 mil (25 ⁇ m).
- a desired characteristic of filter material is that it has a degree of elasticity or some elastomeric attribute.
- the filter material As the fluid is passing through the filter material, it is desirable that the filter material is somewhat elastomeric so that the flow of the bloodstream does not rupture the filter material.
- the filter material should also have high tear strength to withstand the fluid flow across the surface area of the filter material.
- the dip coating process an operator dips a mandrel into polymer which is dissolved in a carrier or solvent. The mandrel is then withdrawn at a certain velocity. Depending on the rate of withdrawal and depending on the viscosity of the fluid, the thickness of the filter material is controlled. However, when the solvent comes off the mandrel, it results in an inconsistent thickness of the filter material. In addition, the dip coating process is limited on how thin the filter material can be formed. Furthermore, the dip molding process at the molecular level results in a very homogeneous molecular structure that actually reduces the tear strength and tensile strength of the resultant filter material. Where the filter material is a thin film, the thin film requires special handling.
- PTFE polytetrafluoroethylene
- PTFE films are generally difficult to work with, requiring dangerous solvents or heat bonding processes.
- extrusion or stretching processes still do not produce the desired film thinness or the desired tear strength required for bloodstream filtering applications.
- the filter material should then be easily deployed such that it closely reforms to its original shape.
- Various characteristics of the filter material influence its ability to be restored back to its original shape. Such characteristics include compliancy, stiffness, thickness, resiliency, and elastomericity.
- Many conventional filter materials do not have adequate compliancy, are too stiff, are too thick, not sufficiently resilient or elastomeric to reform back to the original shape when deployed. Rather, they usually remain partially compressed or end up having many folds or wrinkles on the surface area thereof. However, such folds and wrinkles produces what is known as hysteresis.
- the present invention is directed to filters and methods and apparatuses for constructing such filters.
- the filters of the present invention can be used in embolic protection devices configured to filter embolic debris from the bloodstream of a patient.
- the embolic protection device includes a filter assembly located at a distal end thereof.
- the filter assembly includes a filter and a filter basket.
- the filter basket includes one or more struts which are biased to open outwardly.
- the filter is a generally sack-like structure which includes a closed distal end and an open proximal end. As such, portions of the proximal end are connected to the ends of the struts. When the struts move outwardly, this in turn opens the filter to the flow of the bloodstream.
- the filter is generally a sack-like shape having a distal end and a proximal end.
- the sack-like filter can have any suitable sack-like shape. In one configuration, the sack-like shape has a substantially conical shape.
- the distal end is generally closed, although can have structures (e.g. a guide-wire tip) extending therethrough.
- the filter can have one or more seams extending between the proximal end and the distal end of the filter.
- a seam can be formed as two edges of filter material are bonded together, whether or not such edges are associated with a single piece of filter material, i.e., opposite edges of a single piece of filter material, or two or more pieces of filter material, i.e., one edge from a first piece of filter material and another edge from a second piece of filter material.
- Characteristics which can be desired of the filter material include, but are not limited to, that it is extremely thin, has a degree of elasticity, has high tensile strength, and has high tear strength.
- the filter material has substantially consistent thickness throughout the surface area thereof. Further, it can be desirable for the filter material to have an adequate degree of compliancy so that the filter can easily reform back to its pre-packed shape when deployed in the blood vessel. The filter material should generally exhibit a reduced amount of hysteresis when being deployed. Moreover, it is desirable that the filter material be biocompatible and any bonding processes be biocompatible. In one configuration, the filter material is constructed of one or more thin pieces of material.
- the filter material can be a thin film having a thickness of less than about 25 ⁇ m, less than about lO ⁇ m, or even a thickness of about 5 ⁇ m. In one configuration, the filter material can be a polymer film.
- the polymer film can be formed using a high pressure roller in order to further thin a sheet of polymer film.
- the stressing process undergone by the rollers also aligns the polymer strands which increases the strength of the polymer film.
- Other processes for forming a sufficiently thin film include, but are not limited to, extrusion, stretching, dip molding, blow molding.
- a polyurethane film is used having a thickness of less than 25 ⁇ m.
- the filter can be made from one or more pieces or sections of filter material.
- the filter can be constructed from two pieces of filter material. In another embodiment, the filter can be constructed from a single piece of filter material. In addition, in other configurations, the filter can be constructed from more than two pieces of filter material.
- the sections of filter material are generally cut out or formed from a larger piece of filter material. The sections can be cut, under computer control, by an Eximer laser. Alternatively, the sections can be formed using a pattern. The pattern, having the configuration or shape desired for the section, can be placed over a section of filter material. Once in place, a wide laser beam is passed over the pattern to burn away all of the filter material outside of the periphery of the pattern to leave behind the shaped piece.
- a solvent or a chemical capable of etching or removing a portion of the filter material can be used to wash away materials outside the edges of the pattern.
- Such chemicals can include, but not limited to, caustic chemicals, acids, mixtures of acids or caustic chemicals, or other chemicals capable of etching or removing a portion of the filter material.
- the one or more sections of filter material are each constructed having a substantially tapered configuration. That is, each section of filter material has a proximal end and a distal end with a generally tapering configuration from the proximal end to the distal end. The proximal end can have notched or serrated configurations to assist in connecting the filter to other structures of the filter assembly.
- the section of filter material will include two generally angled edges which can be planer, curved, or alternatively, have protruding portions.
- the edges have a generally parallel portion and a generally angular portion.
- the sections can have various polygonal configurations.
- Each section of filter material includes a porous region.
- the porous region can be formed a distance from the outer periphery of the section or can cover the entire surface of the section.
- the porous regions can be formed during manufacturing of the sections. Alternatively, the porous regions can be formed during the formation of the filter material itself.
- the pores can have various configurations including, but not limited to, circular, oval, polygonal, and the like.
- a clamping assembly can be used to hold together adjacent or overlapping edges of the section(s) of filter material and to protect the rest of the section from the selected bonding process.
- a clamping assembly is provided having a first die portion and a second die portion.
- the first die portion provides a first clamping surface and the second die portion provides a second clamping surface.
- the clamping surfaces are shaped substantially similar to the shape of the pieces of filter material.
- the surface area of the sections of filter material is slightly larger than the surface area of the clamping surfaces so that a portion of the filter material is exposed outside the periphery of the die portions.
- the clamping assembly is selectively positionable between an open and closed position.
- Alignment means can be provided to align the die portions.
- the outer edge of one or both clamping surfaces includes a slightly chamfered edge. This increases the size of the portion of the sections of filter material that can be exposed to the bonding process. Where both clamping surfaces have a chamfered edge, it also creates a groove which holds a bonding agent so that the bonding agent has sufficient space and time to bond the adjacent edges of the filter material together.
- the groove forms a guide for an operator to apply a removing tool to remove portions of the bonding agent and filter material outside and/or within the groove to complete the bonding process.
- the clamping assembly can be constructed from metal, ceramic, plastic or other material which provides a high enough clamping force and is resistant to the selected bonding process.
- the material is preferably reasonably corrosion resistant.
- the process for bonding two sections of filter material can include placing the sections of filter material horizontally on the first clamping surface. A second clamping surface is placed over the overlapped sections. At least a portion of the first edge of the first section overlaps at least a portion of the first edge of the second section. Similarly, at least a portion of the second edge of the first section overlaps at least a portion of the second edge of the second section. The clamping surfaces are then placed in the closed position. In one configuration, at least a portion of the edges are exposed outside of the clamping assembly.
- the edges can then be bonded using a bonding agent, such as solvent or adhesive, heat, or other bonding process, or a combination thereof to form the sack-like filter.
- a tool can be optionally applied to the groove formed by the chamfered edges to remove excess bonding agent and/or the discarded portions of the edges of the sections of filter material.
- the sack-like filter can be formed from a single section of filter material.
- the single section of filter material can be substantially tapered having a first edge, second edge, and a third edge.
- the filter material also has a porous region.
- the first edge and second edge are configured to be bonded together to form the substantially conical shaped sack-like filter.
- a clamping assembly can be provided having, instead of clamping surfaces, a first blade and a second blade.
- the first edge and second edge are overlapped and the blades placed over the overlapping edges to provide a high clamping force thereon.
- the blades can include chamfered edges similar to the clamping surfaces.
- the first edge and second edge can then be bonded using a bonding agent, heat, or other bonding process, or a combination thereof to form the sack-like filter.
- the filter formed of a single piece of filter material results in only one seam, thus minimizing the number of weak points in the filter.
- Figure 1 illustrates a side view of the distal end of an embolic protection device, showing a filter assembly with a filter constructed according to one exemplary embodiment of the present invention, where the filter assembly is in a deployed position
- Figure 2A illustrates a clamping assembly for assembling the filter of Figure l
- Figure 2B illustrates one of the sections of the filter material of Figure 2A
- Figure 2C illustrates a partial side view of the clamping assembly of Figure
- FIG. 1 illustrates a section of filter material for use in constructing a filter according to another embodiment of the present invention
- Figure 3B illustrates a portion of a clamping assembly for assembling the section of filter material of Figure 3 A
- Figure 3C illustrates a portion of another embodiment of a clamping assembly for assembling the section of filter material of Figure 3 A.
- DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS With reference to Figure 1, a portion of an embolic protection device 10 is shown that uses a filter 14 of the present invention. General features of the embolic protection device 10 will be discussed herein, but it will be understood that the filter
- the embolic protection device 10 of the present invention can be used with various other configurations of the embolic protection device.
- the embolic protection device 10 uses the filter 14 to filter the blood flowing therethrough and prevent large pieces of debris from moving downstream of a surgical site.
- the embolic protection device 10 includes a filter assembly 12 located at a distal end of the embolic protection device 10.
- the filter assembly 12 attaches to a distal end of a guide member 16 that aids with positioning the filter assembly 12 within the vasculature of a patient.
- the guide member 16 can have various configurations, so long as it has sufficient torqueability, rigidity, and flexibility to move through the tortuous anatomy of a patient.
- the guide member 16 is a metallic member, while in other configurations the guide member 16 can be composite materials, alloys, or other materials.
- the filter assembly 12 includes the filter 14 and a filter basket 18 to support the filter 14. More specifically, the filter basket 18 includes a proximal end that attaches to a distal end of the guide member 16, while integrally formed with or attached to a distal end of the filter basket 18 are one or more struts 20. These struts 20 move outwardly to deploy the filter 14 during use of the embolic protection device 10. Further details regarding the struts 20, the filter basket 18 and generally the embolic protection device 10 can be found in co-pending United States Patent Application No.
- the filter 14 has a sack-like shape.
- the filter 14 has a distal end 22 and a proximal end 24. The distal end 22 of the filter 14 is illustrated as being closed.
- the proximal end 24 of the filter 14 is open-ended.
- the cross section of the filter 14 is configured to substantially span the cross section of a blood vessel (not shown) in which the filter 14 is located. As such, substantially all of the fluid flowing through the blood vessel comes in contact with a portion of the filter 14. In this manner, the filter 14 is configured to filter embolic debris from a dynamic stream of blood.
- the filter 14 can have one or more seams 26 which result from the bonding of two portions of the filter material forming the filter 14, such that the filter 14 has a sack-like shape.
- the seams 26, only one being shown in Figure 1 generally extend between the distal end 22 and the proximal end 24 of the filter 14.
- the seam 26 can be formed as two edges of filter material are bonded together, whether or not such edges are associated with a single piece of filter material, i.e., opposite edges of a single piece of filter material, or two or more pieces of filter material, i.e., one edge from a first piece of filter material and another edge from a second piece of filter material.
- the manufacture of the filter 14 will be discussed in further detail below.
- the filter material of the filter 14 can be extremely thin, have a high degree of elasticity, have high tensile strength, and have high tear strength.
- the filter material can have a substantially consistent thickness throughout the surface area thereof so as to maximize the strength of the filter material and prevent weak spots. In other configurations, the filter material can have irregular or non-uniform thickness.
- the filter assembly 12 and associated filter 14 are usually tightly packed in some fashion before being deployed in the blood vessel. Suitable filter materials for the filter 14 have an adequate degree of compliancy so that the filter 14 can easily reform back into its pre-packed shape when deployed in the blood vessel.
- the filter material for the filter 14 can be, but not limited to, organic or inorganic polymers.
- Organic polymers include, but are not limited to, low-density polyethylene (LDPE), polyethylene terphthalate (PET), polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyethylene (PE), polyurethane (PU), polycarbonate (PC), polyvinylchloride (PVC), or combinations thereof.
- the filter material can be fabricated from one or more metals, alloys, synthetics, composites, or other materials having the desired medical characteristics and that are capable of being formed as a thin film.
- the filter material for the filter 14 is constructed of one or more thin pieces of material.
- the filter material can be a thin film having a thickness of less than about 25 ⁇ m (1 mil), less than about lO ⁇ m, or even a thickness of about 5 ⁇ m.
- a suitable thin film is selected such that manipulation of the thin film into a sack-like structure is easily facilitated. That is, when working with such thin films, it is desirable to provide processes that are easily implemented manually.
- the filter 14 is intended to be placed within a human body or other organism, it is desirable that the filter material itself be biocompatible and any seams formed on the edges of the thin film are formed using biocompatible bonding agents and/or safe heat processes. It can be understood that the filter material can be fabricated from a mesh or a thin film having a plurality of pores or holes therethrough.
- the filter material forming the filter 14 can be, in one configuration, a polymer film.
- the polymer film can be formed from a rolling process.
- One exemplary process can be, but not limited to, a calendaring process where one or more rollers roller the film as one or more of the rollers move in one direction and one or more of the rollers move in the opposite direction.
- the process uses one or more high pressure roller to further press one or more layers of polymer film in order to make the polymer film even thinner.
- This stressing process undergone by the rollers also has the effect of aligning the polymer strands so as to increase the strength of the polymer film.
- the tear strength can actually be increased by this aligning process despite the fact that the polymer film is becoming even thinner.
- One exemplary polymeric material for applying this thinning process is polyurethane.
- other polymeric materials can be suitable including, but not limited to, those identified above.
- other processes can be suitable for forming a thin film or the filter material of the filter.
- these other processes can include, but are not limited to, extrusion, stretching, pressing, rolling, blow molding or other processes that can create the desired filter material.
- polyurethane films are used because they are biocompatible, can be formed into a sack-like structure using biocompatible methods, provides the desired elasticity, tensile strength and tear strength, and also contains sufficient compliancy so that it reforms substantially back to its original shape with a minimal amount of hysteresis.
- the filter 14 has pores formed therein so as to catch the debris flowing in the blood stream. While the embodiments and configurations of the present invention show that the filter 14 has a substantially conical shape, the filter 14 can be configured into any suitable sack-like shape using the systems and methods taught herein.
- the filter 14 can be made from one or more pieces of filter material.
- the filter 14 can be constructed from two pieces of filter material, as illustrated in Figures 2A-2C.
- the filter 14 can be constructed from a single piece of filter material, as is illustrated in Figure 3A-3C. While the pieces of filter material shown in Figure 2A-2C and 3A-3C are shown as substantially flat, it will be appreciated that they can, in reality, have nonflat portions as commonly found in flexible materials.
- the filter 14 is constructed from two pieces of filter material identified as a first section 100A and a second section 100B.
- first section 100A and the second section 100B are cut and configured to have substantially the same shape.
- the first section 100A and the second section 100B can be cut, under computer control, by an Eximer laser.
- the first section 100A and the second section 100B can be formed through use of a pattern.
- the pattern having the configuration or shape desired for the first section 100A and the second section 100B can be placed over a section of filter material, such as a section of polymer film.
- first section 100A and the second section 100B an exemplary configuration of the first section 100A and the second section 100B is shown in Figure 2A. Both sections 100A, 100B have a substantially tapered configuration. The following discussion will primarily describe an exemplary configuration of first section 100A, however, a similar discussion can be provided for the second section 100B.
- the first section 100A has a substantially tapered configuration and includes a proximal end 102A and a distal end 104A, with the first section 100A generally tapering from the proximal end 102A to the distal end 104.
- the proximal end 102A has a generally notched or serrated configuration with a plurality of protruding portions 106A which assist in connecting the filter 14 (Figure 1) to other structures of the filter assembly 12 ( Figure 1).
- protruding portions 106A can be connected to the distal ends of or other portion of one or more struts 18.
- edges 108 A and 110A Extending from the proximal end 102 A toward the distal end 104 A are edges 108 A and 110A. These edges 108 A and 110A are illustrated as being generally planar, however, the edges 108A and 110A can be curved or, alternatively, have protruding portions.
- the edges 108A and 110A have generally parallel first portions 112A and 114A and second portions 116A and 118 A that are angularly orientated one to another.
- the inclusion of generally parallel first portions 112A and 114A aids with increasing the volume of filter 14 (Figure 1) when first section 100 A and second section 100B form filter 14. Additionally, the parallel first portions 112A and 114A form a constant cross-sectional portion of filter 14 that contacts the vessel wall during use of filter 14.
- parallel first portions 112A and 114A aid with creating a secure fit with struts 20 (Figure 1) of filter basket 18 because the parallel portions 112A and 114A following the profile of filter basket 18.
- the second portions 116A and 118A of first portion 112A and second portion 114A terminate at the distal end 104 A, which can have a planar, curved, or pointed configuration.
- each edge 108 A and 110A can taper from the proximal end 102 A to the distal end 104A without the inclusion of generally parallel first portions 112A and 114A.
- edges 108 A and 110A can be substantially parallel from the proximal end 102A to the distal end 104A without the inclusion of generally angular second portions 116A and 118A.
- the first section 100 A can have any desired polygonal configuration so long as it is capable of being formed into a sac-like configuration and attached to the filter assembly 12 ( Figure 1) so that it can collect emboli from flowing blood.
- the first section 100A includes a porous region 120A.
- the porous region 120A is formed a distance from the outer periphery of the first section 100A. That is, a solid boundary 122 A is formed around the porous region 120 A.
- the porous region 120 A can be formed over the entire surface of first section 100 A.
- the solid boundary 122 A is configured such that when the first section 100A and second section 100B are placed adjacent to each other, the solid boundaries formed on the sections overlap and provide a surface that aids with bonding the first section 100 A and the second section 100B together. As will be discussed further below, some or all of the solid portions 122 A is eventually discarded leaving behind mostly the porous regions 120A.
- the porous region 120A can be formed during manufacturing of the shapes of sections 120A.
- the pattern used to form the sections 100A and 100B can include a plurality of holes that match the location of the pores of the porous region 120A.
- the pores are formed in the filter material.
- a small diameter beam from a laser is used to form each individual pore.
- solvents can be used to form the pores in porous region 120A.
- the pores need not be formed during the process of forming sections 100A and 100B.
- the filter material such as a polymer film, can contain sufficiently sized pores such that additional pores do not need to be formed during the processes performed to form the first section 100A and the second section 100B.
- the pores formed in the filter material of the filter 14 can have a variety of different configurations, such as but not limited to circular, oval, polygonal, combinations thereof or other configurations known to one skilled in the art in light of the teaching contained herein.
- the filter 14 includes uniformly sized pores having a diameter ranging from about 50 ⁇ m to about 200 ⁇ m. In another configuration, the diameter of the pores ranges from about 60 ⁇ m to about 180 ⁇ m. In still another configuration, the diameter of the pores ranges from about 75 ⁇ m to about 150 ⁇ m. In another configuration, the filter 14 can include pores that are differently sized and configured. Consequently, a major or minor axis of each pore can have a variety of different sizes ranging from about 50 ⁇ m to about 200 ⁇ m, from about 60 ⁇ m to about 180 ⁇ m, or from about 75 ⁇ m to about 150 ⁇ m.
- the pore size can vary as needed, so long as the pores are sized so that the pores do not compromise blood flow through the filter 14, i.e., prevent blood flowing through the filter, and collect material that could potentially occlude smaller downstream vessels, potentially blocking blood flow to tissue or result in stroke or infarction.
- the length L] of sections 100A is about 8mm to about 20mm.
- the length L 2 of the porous region 120A is about 7mm to about 19mm.
- the width of Wi of the sections 100A is about 3mm to about 14mm.
- the width of W 2 of the porous region 120 A is from about 25mm to about 13mm.
- first section 100A also apply to the second section 100B.
- Sections 100A and 100B can have substantially the same size, or, alternatively, can differ in size. Discussed thus far are the characteristics of the first section 100A and the second section 100B and the manner by which such are formed.
- Forming first section 100 A and second section 100B is an initial step in the process of forming the filter 14 ( Figure 1).
- the pre-forming process can occur immediately before the process for joining, coupling or attaching two or more sections to create the filter 14 or occur at any time prior to the process of joining, coupling or attaching two or more sections to create the filter 14.
- a clamping assembly 200 is used.
- the clamping assembly 200 includes a first die portion 202A and a second die portion 202B.
- the die portions 202A, 202B provide first clamping surface 204A and second clamping surface 204B between which pieces of the filter material are placed and clamped during the filter construction process.
- the clamping surfaces 204A, 204B of the first and second die portions 202A, 202B are preferably shaped substantially similar to the shape of the pieces of filter material.
- the clamping surfaces 204A, 204B preferably have a similarly-shaped periphery each having two parallel portions and two angled portions.
- the periphery of the clamping surfaces 204A, 204B is smaller than the periphery of the sections 100 A and 100B of the filter material. This allows portions of the filter material to be exposed outside the periphery of the die portions 202A, 202B to be accessible for bonding processes, which will be discussed further below.
- the vertical sides of the die portions 202A, 202B are shown as substantially rectilinear such that, for example with regard to die portion 202A, the top surface has substantially the same shape as the clamping surface 204A. However, the vertical sides can be curved or tapered.
- One function of the clamping assembly 200 is to hold the piece(s) of filter material during assembly of the sack-like configuration.
- the clamping assembly 200 can be used to hold adjacent edges of the filter material together, whether from the same or different pieces of filter material.
- the clamping assembly 200 can be selectively positioned between an open and closed position.
- the die portions 202A, 202B include means for aligning the die portions when in the closed position.
- the top die portion 202A includes alignment pins 206 while the bottom die portion 202B includes alignment apertures 208.
- the alignment pins 206 are disposed in the alignment apertures 208 to align the die portions 202A, 202B.
- Other configurations for aligning die portions 202A, 202B can be applied. For instance, the location of the pins 206 and the apertures 208 can be reversed.
- clamping assembly 200 Another function of the clamping assembly 200 is to form the boundaries for the bonding process. That is, the clamping assembly 200 allows the desired amount of filter material to be exposed to the bonding process, while protecting the rest of the filter material. As shown in Figure 2C, the outer edge of the first clamping surface 204A and second clamping surface 204B has a slightly chamfered edge 210A, 210B. The length of the chamfer, X, is from about 75 ⁇ m (3 mils) to about 200 ⁇ m (8 mils).
- the length of the chamfer X is about 125 ⁇ m (5 mils).
- the clamping surfaces 204A, 204B provide an exposed portion of the sections 100A, 100B to be available for a bonding process.
- specific exemplary dimensions are provided herein, it will be understood by those skilled in the art that the chamfer can have any desired length based upon the amount of filter material used to bond the edges of the filter material to form the filter 14.
- the combined chamfered edges 210A, 210B form a groove 212 which can hold bonding agent during the bonding process.
- a tool e.g., a cotton swab, a bit, etc.
- a tool can be run along the length of the groove 212 to remove excess bonding agent and/or filter material. In this manner, the excess filter material can be removed.
- the depth of chamfer, X also forms the inner clamping edge, Y, beyond which, the bonding processes cannot substantially penetrate.
- the bonding process includes using bonding agents to create the desired bond
- the die portions 202A and 202B are clamped together with a sufficient force to prevent migration of the bonding agent substantially past the inner clamping edge Y.
- One or both clamping surfaces 204A, 204B can have a chamfered edge.
- neither clamping surface 204A, 204B can have a chamfered edge.
- the periphery of the sections 100A, 100B of the filter material can be formed larger than the periphery of the clamping surfaces 204 A, 204B such that a portion of the filter material extends beyond the periphery of the clamping surfaces 204A and 204B.
- the sections 100A, 100B are exposed a distance Z past the clamping surfaces 204A and 204B. In one embodiment, the distance Z is about 500 ⁇ m (20 mils). This way, if the alignment of the first section 100A and second section 100B is off, it does not interfere with the formation of the filter.
- clamping assembly 200 can have a blade configuration, discussed in more detail below.
- the die portions 202A, 202B are constructed of a metal material.
- the metal can be a stainless steel or tungsten.
- the clamping surfaces 204A and 204B are constructed of a ceramic material.
- it is important that the material from which the clamping surfaces 204A and 204B are constructed is sufficient to withstand the selected bonding process and also provides enough clamping force between the two surfaces so as to prevent bonding agent or heat from penetrating too deep within the clamped area.
- An exemplary process for bonding two sections of the filter material using the clamping assembly 200 is as follows. The first and second sections 100A, 100B are placed facing each other and laid horizontally on a first clamping surface 204A. A second clamping surface 204B is placed over the overlapped sections.
- the first section 100A overlaps the second section 100B such that at least a portion of the first edge 108A overlaps at least a portion of the second edge 108B and at least a portion of the second edge 110A overlaps at least a portion of the second edge HOB of the second section 104B.
- the first and second clamping surfaces 204A and 204B are closed using alignment pins 206 and alignment apertures 208 to align the clamping surfaces 204A and 204B.
- first clamping surface and second clamping surface 204A, 204B are configured to have substantially the same shape as the first section 100A and second section 100B, when the clamping assembly closes, at least a portion of edges 108A, 108B and 110A, HOB are left exposed outside of the clamping assembly 200. However, portions of sections 100A, 100B can also be exposed without the clamping surfaces 204A and 204B being shaped the same as the sections 100A, 100B. As shown in Figure 2C, the exposed portion of the edges 108A, 108B and 110A, HOB is available for a bonding process. In one embodiment, the bonding process includes applying a bonding agent to the exposed portion of the overlapped edges 108, 110.
- the bonding agent could be a solvent, a polymer dissolved in a solvent, an adhesive, and the like.
- the bonding agent acts to bond the first section 100A to the second section 100B.
- the solvent also allows excess amounts of the filter material to be discarded so that a resulting seam (Figure 1) formed between the first section 100A and second section 100B is extremely small.
- a low viscosity bonding agent is applied. The operator should ensure that the first clamping surface 204A and second clamping surface 204B are tightly engaged over the sections 100A, 100B so that the bonding agent does not penetrate beyond the inner clamping edge, Y.
- the solvent is dimethyl sulfoxide (DMSO).
- DMSO dimethyl sulfoxide
- other solvents can also be suitable including, but not limited to, cyclohexanone, Stoddard solvent, acetone, or other solvents that can dissolve the filter material being used to form the filter.
- Suitable adhesives for use as bonding agents include, but are not limited to, cyanoacrylates and acrylic adhesives.
- the bonding process includes applying heat to the exposed portions of the edges 108, 110.
- the heat drives away the excess filter material while providing a bond between the first section 100A and second section 100B.
- a combination of a bonding agent and heat can be used to bond the first section 100A to the second section 100B.
- the bonding process can include a laser welding process.
- the selected bonding process provides the seam 26 ( Figure 1) having the same or close to the same tensile strength as that of the filter material.
- a tool e.g., a cotton swab
- a tool can be applied to the groove 212 formed by the chamfered edges 210A, 21 OB.
- FIG. 3A shows a substantially tapered section 300 of filter material.
- the section 300 of filter material includes a first edge 302, second edge 304, and a third edge 306.
- the first edge 302 and second edge 304 are substantially linear while the third edge 306 has a curved shape.
- section 300 includes a porous region 308 that can have a similar configuration to the porous region 120. It will be appreciated that the section 300 can be constructed according to the methods described above with reference to sections 100A, and 100B.
- the first edge 302 is configured to bond to the second edge 304.
- a substantially sack-like filter can be formed having only a single seam 26 (Figure 1) formed thereon.
- the first edge 302 and second edge 304 are overlapped and placed between a clamping assembly 400.
- the clamping assembly 400 includes a first blade 402 and a second blade 404.
- the first blade and second blade 402, 404 act to provide a high clamping force to the overlapping edges 302, 304.
- the blades can be chamfered similar to that described above with respect to clamping surfaces 204 A, 204B.
- the blades 402, 404 allow at least a portion of edges 302, 304 of section 300 to be exposed to a bonding process while at the same time protecting the rest of the section from the bonding process.
- a substantially conical sack-like filter is formed form a single piece of filter material.
- An additional step can be required to provide bonding agent or other bonding process at the tip 312 ( Figure 3 A) in order to close the end of the filter.
- a filter having only one seam 26 ( Figure 1) provides reduced number of steps for forming the filter. This can be desirable, especially in the embodiments where the filter material is extremely thin and difficult to handle.
- Figure 3C another embodiment for placing the overlapping edges 302, 304 of section 300 is shown.
- non-facing surfaces of the edges are placed adjacent each other. Bonding can then occur along one side of the blades 308, 310 to meld or melt the edges together.
- the blade clamping assembly 400 can be applied to the embodiment having two sections of the filter material.
- a clamping surface clamping assembly 200 can be applied to the single-piece embodiment to form the single seam.
- the edges of the filter material can be manually held together and then a bonding process applied. It will be understood that the blades and dies of the present invention can be moved through use of a variety of techniques and structures.
- the blades and dies can be mounting within racks or on tracks (not shown) that facilitate movement of the blades or dies during the bonding process.
- the blades and dies can, therefore, be moved under the influence of pneumatic or hydraulic rams, rack and gear systems, or other structures that can be used to move one die or blade toward another die or blade in a controlled and repeatable manner.
- the blades and dies can be moved manually, automatically, or under the control of one or more electronic components that control the motion and position of the blades and dies.
- the present invention can be embodied in other specific forms without departing from its spirit or essential characteristics.
- the described embodiments are to be considered in all respects only as illustrative and not restrictive.
- the scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
- Filtering Materials (AREA)
- Materials For Medical Uses (AREA)
- Manufacture Of Macromolecular Shaped Articles (AREA)
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
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JP2007503909A JP2007529595A (en) | 2004-03-15 | 2005-02-10 | Filter material and manufacturing method thereof |
EP05713558A EP1753498A4 (en) | 2004-03-15 | 2005-02-10 | Filter media and methods of manufacture |
AU2005227111A AU2005227111A1 (en) | 2004-03-15 | 2005-02-10 | Filter media and methods of manufacture |
CA002559895A CA2559895A1 (en) | 2004-03-15 | 2005-02-10 | Filter media and methods of manufacture |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US10/800,522 | 2004-03-15 | ||
US10/800,522 US7473265B2 (en) | 2004-03-15 | 2004-03-15 | Filter media and methods of manufacture |
Publications (2)
Publication Number | Publication Date |
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WO2005091813A2 true WO2005091813A2 (en) | 2005-10-06 |
WO2005091813A3 WO2005091813A3 (en) | 2007-06-07 |
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PCT/US2005/004722 WO2005091813A2 (en) | 2004-03-15 | 2005-02-10 | Filter media and methods of manufacture |
Country Status (6)
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US (1) | US7473265B2 (en) |
EP (1) | EP1753498A4 (en) |
JP (1) | JP2007529595A (en) |
AU (1) | AU2005227111A1 (en) |
CA (1) | CA2559895A1 (en) |
WO (1) | WO2005091813A2 (en) |
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-
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- 2005-02-10 EP EP05713558A patent/EP1753498A4/en not_active Withdrawn
- 2005-02-10 CA CA002559895A patent/CA2559895A1/en not_active Abandoned
- 2005-02-10 AU AU2005227111A patent/AU2005227111A1/en not_active Abandoned
- 2005-02-10 JP JP2007503909A patent/JP2007529595A/en active Pending
- 2005-02-10 WO PCT/US2005/004722 patent/WO2005091813A2/en not_active Application Discontinuation
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See references of EP1753498A4 * |
Also Published As
Publication number | Publication date |
---|---|
EP1753498A4 (en) | 2012-10-24 |
AU2005227111A1 (en) | 2005-10-06 |
WO2005091813A3 (en) | 2007-06-07 |
US20050203567A1 (en) | 2005-09-15 |
EP1753498A2 (en) | 2007-02-21 |
JP2007529595A (en) | 2007-10-25 |
CA2559895A1 (en) | 2005-10-06 |
US7473265B2 (en) | 2009-01-06 |
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