US20060130332A1 - Filter frame - Google Patents
Filter frame Download PDFInfo
- Publication number
- US20060130332A1 US20060130332A1 US11/276,566 US27656606A US2006130332A1 US 20060130332 A1 US20060130332 A1 US 20060130332A1 US 27656606 A US27656606 A US 27656606A US 2006130332 A1 US2006130332 A1 US 2006130332A1
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- US
- United States
- Prior art keywords
- frame
- filter
- mandrel
- struts
- distal
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2/0105—Open ended, i.e. legs gathered only at one side
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2002/018—Filters implantable into blood vessels made from tubes or sheets of material, e.g. by etching or laser-cutting
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0004—Rounded shapes, e.g. with rounded corners
- A61F2230/0006—Rounded shapes, e.g. with rounded corners circular
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0067—Three-dimensional shapes conical
-
- 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
- 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
- A61F2230/0097—Harpoon-shaped
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/496—Multiperforated metal article making
- Y10T29/49604—Filter
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
Definitions
- the present invention pertains to distal protection catheters for filtering embolic debris. More precisely, the present invention pertains to distal protection filters including a refinement to the filter frame.
- Heart disease is a major problem in the United States and throughout the world. Conditions such as atherosclerosis result in blood vessels becoming blocked or narrowed. This blockage can result in lack of oxygenation of the heart, which has significant consequences since the heart muscle must be well oxygenated in order to maintain its blood pumping action.
- Occluded, stenotic, or narrowed blood vessels may be treated with a number of relatively non-invasive medical procedures including percutaneous transluminal angioplasty (PTA), percutaneous transluminal coronary angioplasty (PTCA), and atherectomy.
- Angioplasty techniques typically involve the use of a balloon catheter. The balloon catheter is advanced over a guidewire such that the balloon is positioned adjacent a stenotic lesion. The balloon is then inflated and the restriction of the vessel is opened. During an atherectomy procedure, the stenotic lesion may be mechanically cut away from the blood vessel wall using an atherectomy catheter.
- embolic debris can be separated from the wall of the blood vessel. If this debris enters the circulatory system, it could block other vascular regions including the neural and pulmonary vasculature, both of which are highly undesirable. During angioplasty procedures, stenotic debris may also break loose due to manipulation of the blood vessel. Because of this debris, a number of devices, termed distal protection devices, have been developed to filter out this debris.
- the present invention pertains to distal protection filter assemblies. More particularly, the present invention pertains to distal protection filter frames.
- a filter frame may include a plurality of struts or ribs and a crown or mouth portion. The crown portion may be adapted and configured to have a distal protection filter coupled thereto.
- a mandrel may include a proximal region, a distal region, and a middle region.
- the mandrel may include grooves for holding the filter frame in place.
- the mandrel may include openings leading to a guidewire channel or a screw dip rod.
- FIG. 1 is a cross sectional view of a distal protection filter disposed within the vasculature of a patient;
- FIG. 2 is a perspective view of a filter frame for use with a distal protection filter
- FIG. 3 is a flattened plan view of the filter frame
- FIG. 4 is a perspective view of an alternate filter frame for use with a distal protection filter
- FIG. 5 is a flattened plan view of the alternate distal protection filter frame
- FIG. 6 is a perspective view of a mandrel for use in forming a distal protection filter frame
- FIG. 7 is a perspective view of an alternate mandrel for use in forming a distal protection filter frame
- FIG. 8 is a cross sectional view taken through line 7 - 7 of the mandrel shown in FIG. 7 ;
- FIG. 9 is a perspective view of a second alternate mandrel for use in forming a distal protection filter frame.
- FIG. 1 is a cross sectional view of a distal protection filter disposed within the vasculature of a patient.
- embolic debris may drift away from the treatment site and, potentially, obstruct downstream vascular regions. These obstructions could lead to adverse medical conditions and/or tissue damage.
- a strategy that may help prevent embolic debris from causing problems downstream of an intravascular procedure may include the use of a distal protection filter 10 .
- Distal protection filter 10 includes a filter frame 12 having a filter material 14 coupled thereto.
- Filter frame 12 may be comprised of metal such as nickel-titanium alloy or stainless steel and configured to have one or more struts 18 coupled to an elongate shaft or guidewire 20 , and a crown defining mouth portion 22 coupled to filter material 14 .
- Frame 12 may be self-expanding so that frame 12 will expand to engage and generally conform to the internal lumen a blood vessel 16 when being delivered (e.g., from a delivery catheter or sheath).
- Distal protection filter material 14 may be coupled to guidewire 20 proximate a distal end of guidewire 20 .
- Filter material 14 and guidewire 20 may generally comprise a number of configurations known to those skilled in the appropriate art.
- Filter material 14 may be comprised of a polyurethane sheet and include at least one opening that may be, for example, formed by known laser techniques. The holes or openings are sized to allow blood flow therethrough but restrict flow of debris or emboli floating in the body lumen or cavity.
- Filter 10 may be generally cone-shaped, and have a proximal and a distal end. The distal end may be a narrow, “V”-shaped end and is secured to guidewire 20 and/or frame 12 . Alternatively, filter 10 may be cylindrical with a relatively rounded distal end. Filter 10 operates between a closed collapsed profile and an open radially-expanded deployed profile for collecting debris in a body lumen. In an expanded profile, the mouth is opened and struts 18 extend radially outwardly to support the mouth. Struts 18 may be coupled to guidewire 20 by a strut coupling member 23 . A number of differing configurations of filter material 14 may be substituted without departing from the spirit of the invention.
- a portion of frame 12 may be comprised of or plated with radiopaque materials.
- Radiopaque materials are understood to be capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during an intravascular procedure. This relatively bright image aids the user of distal protection assembly 10 in determining the location of frame 12 with respect to the patient's vascular anatomy.
- Radiopaque materials may include, but are not limited to, gold, platinum, tungsten alloy, and plastic material loaded with a radiopaque filler.
- FIG. 2 is a perspective view of filter frame 12 for use with distal protection filter material 14 .
- filter frame 12 may be constructed with a geometry that is optimized for essentially complete apposition to the internal wall of blood vessel 16 (i.e., frame 12 conforms to the shape of blood vessel 16 ) and minimal peak strains within frame 12 .
- Peak strain is understood to be strain at points along frame 12 where force is concentrated. Therefore, peak strain may be minimized by distributing the force evenly throughout frame 12 .
- frame 12 includes a greater expansion ratio. Expansion ratio is understood to be the ratio of the diameter (or area) of frame 12 between an expanded configuration and a collapsed configuration. Increasing the expansion ratio may allow frame 12 to be collapsed to a generally small profile and still be capable of expanding to conform to the size of a blood vessel. These and other features may allow frame 12 to be delivered with a small profile.
- Struts or ribs 18 may be pre-curved during manufacturing to include a first curved portion 24 .
- stress on frame 12 may longitudinally deform or strain frame 12 .
- Curved portion 24 has a constant radius so that when frame 12 is collapsed, stress and/or strain forces are evenly distributed longitudinally throughout frame 12 . According to this embodiment, the peak strain within struts 18 and/or frame 12 when frame 12 may be minimized by including curved portion 24 .
- Struts 18 and crown portion 22 may be continuous and be joined by a second curved portion 26 . Similarly to curved portion 24 , portion 26 is also curved to minimize peak strain near crown portion 26 . However, the radius of curvature of curved portion 26 may be variable or include portions where the radius varies. In addition, crown portion 22 extends between a distal end 28 and a plurality of strut intersection points 30 . Struts 18 may extend from points 30 and be coupled to guidewire 20 .
- frame 12 may include two, three, four, five, six, or more points. It is believed that increasing the number of struts 18 and/or points 30 would decrease the expansion ratio of frame 12 . For example, increasing the number of points 30 from four to six would increase the inside diameter of frame 12 . Different diameter sizes may be favored when performing an intravascular procedure within different blood vessels.
- FIG. 3 is a flattened plan view of distal protection filter frame 12 .
- frame 12 it may be beneficial to first manufacture a planer version of the appropriate material (e.g., nickel-titanium alloy).
- the planer version may be formed into the desired shape by disposing frame 12 about a mandrel (examples are shown below in FIGS. 6-9 ) and coupling opposite ends together, for example by soldering or welding.
- FIG. 4 is a perspective view of an alternate filter frame 112 for use with distal protection filter material 14 .
- Frame 112 is essentially the same in form and function as frame 12 in that frame 112 , except that frame 112 further comprises distally-oriented struts 132 in addition to struts 118 .
- Distally-oriented struts 132 extend distally between distal end 128 of crown portion 122 and guidewire 20 .
- Struts 132 provide additional support for filter material 14 .
- struts 132 may be adapted and configured to follow the contour of filter material 14 and provide structural support along the length thereof.
- struts 132 may be coupled to the distal end of filter material 14 and/or be coupled to guidewire 20 .
- FIG. 5 is a flattened plan view filter frame 112 .
- FIG. 6 is a perspective view of a mandrel 34 for use in manufacturing a distal protection filter frame (e.g., frame 12 and frame 112 ).
- Mandrel 34 includes a generally tapered or cone-like distal region 36 , a middle region 38 , and a tapered proximal region 40 .
- mandrel 34 may include a distal tip 42 and a proximal tip 44 disposed proximate their respective regions. It should be appreciated that although the subsequent discussion is focused upon frame 12 it is similarly applicable to frame 112
- Middle region 38 includes grooves 46 adapted and configured for holding at least a portion of filter frame 12 .
- Grooves 46 are curved such that disposing crown portion 22 within grooves 46 may lead to the formation of second curved portion 26 .
- the transition from the relatively straight middle region 38 to the tapered proximal region 40 may lead to the formation of first curved portion 24 , although pre-curving may be desirable if the transition between proximal region 40 and middle region 38 bends more sharply than desired.
- planer configurations shown in FIGS. 3 and 5 of frame 12 may be disposed about mandrel 34 such that crown portion 22 or 122 is disposed within groove 46 .
- Struts 18 may extend between middle region 38 and proximal region 40 wherein the transition between regions tapers struts 18 toward the center and can be used to form first curve 24 .
- the proximal ends of struts 18 may be disposed near proximal tip 44 where they may be coupled to guidewire 20 .
- a collar 47 may be slidably disposed along middle region 38 that is adapted and configured to be slid over struts 18 and/or crown portion 22 (or crown portion 122 ) to hold frame 12 in position.
- frame 12 may be set to conform to the shape of the mandrel using methods described below or those known in the art. Following shape setting, frame 12 can be removed from mandrel 34 or it may be coupled with filter material 14 , for example by dipping distal region 36 into molten or partially molten filter material 14 .
- Heat setting may be used to set the shape of frame 12 (and frame 112 ).
- frame 12 may be comprised of a shape memory alloy that can be heat set.
- frame 12 may be disposed about mandrel 34 and heated to set the shape of frame 12 to conform to the shape of mandrel 34 .
- mandrel 34 (and subsequently described mandrels) may be comprised of materials that would resist heat deformation such as stainless steel.
- frame 12 deformed to an alternate shape will return to the heat set shape after force used to deform frame 12 is removed. It may be desirable to heat set frame 12 in the expanded configuration such that delivery of filter 10 from within a relatively small delivery sheath permits frame 12 to self-expand when the delivery sheath is withdrawn.
- mandrel 34 may be hollow such that guidewire 20 may pass therethrough with opposing end extending from distal tip 42 and proximal tip 44 .
- This embodiment may simplify the process of coupling struts 18 (or struts 132 ) to guidewire 20 if desired by establishing proper alignment. This step may similarly achieved independently of mandrel 34 .
- struts 132 extend between middle region 38 and distal region 36 wherein struts 132 taper toward the center. The distal ends of struts 132 may be disposed near distal tip 42 where they may be coupled to guidewire 20 .
- filter material 14 may be coupled thereto.
- suitable filter materials may be molten or partially molten and frame 12 or 112 may be coupled to filter material 14 by dipping distal region 36 (or 136 ) into the suitable filter materials 14 as described above. It should be appreciated that a person of ordinary skill in the art would be familiar with suitable filter materials and method for coupling filter material 14 to frame 12 .
- FIG. 7 is a perspective view of an alternate mandrel 134 for use in forming a distal protection filter frame.
- Mandrel 134 is similar to mandrel 34 in that it includes distal region 136 , middle region 138 , proximal region 140 , distal tip 142 , and grooves 146 .
- middle region 138 of mandrel 134 include one or more openings 148 to a guidewire channel 150 . Openings 148 may be used for shaping struts or be a place for struts to extending during formation of the filter frame.
- a filter frame may be configured such that struts or ribs 18 pass through openings 148 , into a strut channel 152 and come together at an apex 154 . Openings 148 may be useful for tapering struts 18 toward guidewire 20 .
- use of mandrel 134 may be similar to that of mandrel 34 .
- FIG. 8 is a cross sectional view taken through line 7 - 7 of the mandrel shown in FIG. 7 showing channels 152 .
- FIG. 9 is a perspective view of a second alternate mandrel 234 for use in forming a distal protection filter frame.
- Mandrel 234 is similar to mandrel 34 in form and function in that it includes distal region 236 , middle region 238 , proximal region 240 , distal tip 242 , and grooves 246 .
- middle region 238 of mandrel 234 includes a screw dip rod 256 .
- Filter frame 112 may be coupled to mandrel 234 such that crown portion 122 is disposed about middle region 238 and struts 132 are disposed within grooves 246 and extend toward distal tip 242 .
- Screw dip rod 256 may be actuated so as to pass over and hold or set the shape of crown portion 122 into a generally circular configuration. Then, heat may be used to set the shape similarly to what is described above.
- Struts 132 may be coupled to guidewire 20 that may pass through mandrel 234 and exit therefrom at distal tip 242 .
- Filter material 14 may be formed in a manner similar to what is described above.
Abstract
Distal protection filter frame and method for using and manufacturing the same. A distal protection filter frame may include one or more struts, a mouth, and a filter coupled to the mouth.
Description
- This application is a continuation application of U.S. patent application Ser. No. 10/099,219 filed on Mar. 13, 2002.
- 1. Field of the Invention
- The present invention pertains to distal protection catheters for filtering embolic debris. More precisely, the present invention pertains to distal protection filters including a refinement to the filter frame.
- 2. Description of the Related Art
- Heart disease is a major problem in the United States and throughout the world. Conditions such as atherosclerosis result in blood vessels becoming blocked or narrowed. This blockage can result in lack of oxygenation of the heart, which has significant consequences since the heart muscle must be well oxygenated in order to maintain its blood pumping action.
- Occluded, stenotic, or narrowed blood vessels may be treated with a number of relatively non-invasive medical procedures including percutaneous transluminal angioplasty (PTA), percutaneous transluminal coronary angioplasty (PTCA), and atherectomy. Angioplasty techniques typically involve the use of a balloon catheter. The balloon catheter is advanced over a guidewire such that the balloon is positioned adjacent a stenotic lesion. The balloon is then inflated and the restriction of the vessel is opened. During an atherectomy procedure, the stenotic lesion may be mechanically cut away from the blood vessel wall using an atherectomy catheter.
- During angioplasty and atherectomy procedures, embolic debris can be separated from the wall of the blood vessel. If this debris enters the circulatory system, it could block other vascular regions including the neural and pulmonary vasculature, both of which are highly undesirable. During angioplasty procedures, stenotic debris may also break loose due to manipulation of the blood vessel. Because of this debris, a number of devices, termed distal protection devices, have been developed to filter out this debris.
- The present invention pertains to distal protection filter assemblies. More particularly, the present invention pertains to distal protection filter frames. A filter frame may include a plurality of struts or ribs and a crown or mouth portion. The crown portion may be adapted and configured to have a distal protection filter coupled thereto.
- A number of different mandrels may be used to manufacture the filter frame. For example, a mandrel may include a proximal region, a distal region, and a middle region. In addition, the mandrel may include grooves for holding the filter frame in place. Further, the mandrel may include openings leading to a guidewire channel or a screw dip rod.
-
FIG. 1 is a cross sectional view of a distal protection filter disposed within the vasculature of a patient; -
FIG. 2 is a perspective view of a filter frame for use with a distal protection filter; -
FIG. 3 is a flattened plan view of the filter frame; -
FIG. 4 is a perspective view of an alternate filter frame for use with a distal protection filter; -
FIG. 5 is a flattened plan view of the alternate distal protection filter frame; -
FIG. 6 is a perspective view of a mandrel for use in forming a distal protection filter frame; -
FIG. 7 is a perspective view of an alternate mandrel for use in forming a distal protection filter frame; -
FIG. 8 is a cross sectional view taken through line 7-7 of the mandrel shown inFIG. 7 ; and -
FIG. 9 is a perspective view of a second alternate mandrel for use in forming a distal protection filter frame. - The following description should be read with reference to the drawings wherein like reference numerals indicate like elements throughout the several views. The detailed description and drawings illustrate example embodiments of the claimed invention.
-
FIG. 1 is a cross sectional view of a distal protection filter disposed within the vasculature of a patient. When performing any one of a number of differing intravascular procedures, embolic debris may drift away from the treatment site and, potentially, obstruct downstream vascular regions. These obstructions could lead to adverse medical conditions and/or tissue damage. A strategy that may help prevent embolic debris from causing problems downstream of an intravascular procedure may include the use of adistal protection filter 10.Distal protection filter 10 includes afilter frame 12 having afilter material 14 coupled thereto. -
Filter frame 12 may be comprised of metal such as nickel-titanium alloy or stainless steel and configured to have one ormore struts 18 coupled to an elongate shaft orguidewire 20, and a crown definingmouth portion 22 coupled tofilter material 14.Frame 12 may be self-expanding so thatframe 12 will expand to engage and generally conform to the internal lumen ablood vessel 16 when being delivered (e.g., from a delivery catheter or sheath). - Distal
protection filter material 14 may be coupled to guidewire 20 proximate a distal end ofguidewire 20.Filter material 14 andguidewire 20 may generally comprise a number of configurations known to those skilled in the appropriate art.Filter material 14 may be comprised of a polyurethane sheet and include at least one opening that may be, for example, formed by known laser techniques. The holes or openings are sized to allow blood flow therethrough but restrict flow of debris or emboli floating in the body lumen or cavity. -
Filter 10 may be generally cone-shaped, and have a proximal and a distal end. The distal end may be a narrow, “V”-shaped end and is secured to guidewire 20 and/orframe 12. Alternatively,filter 10 may be cylindrical with a relatively rounded distal end.Filter 10 operates between a closed collapsed profile and an open radially-expanded deployed profile for collecting debris in a body lumen. In an expanded profile, the mouth is opened andstruts 18 extend radially outwardly to support the mouth.Struts 18 may be coupled to guidewire 20 by astrut coupling member 23. A number of differing configurations offilter material 14 may be substituted without departing from the spirit of the invention. - In addition, a portion of
frame 12 may be comprised of or plated with radiopaque materials. Radiopaque materials are understood to be capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during an intravascular procedure. This relatively bright image aids the user ofdistal protection assembly 10 in determining the location offrame 12 with respect to the patient's vascular anatomy. Radiopaque materials may include, but are not limited to, gold, platinum, tungsten alloy, and plastic material loaded with a radiopaque filler. -
FIG. 2 is a perspective view offilter frame 12 for use with distalprotection filter material 14. A number of features may be incorporated intofilter frame 12. For example,filter frame 12 may be constructed with a geometry that is optimized for essentially complete apposition to the internal wall of blood vessel 16 (i.e.,frame 12 conforms to the shape of blood vessel 16) and minimal peak strains withinframe 12. Peak strain is understood to be strain at points alongframe 12 where force is concentrated. Therefore, peak strain may be minimized by distributing the force evenly throughoutframe 12. In addition,frame 12 includes a greater expansion ratio. Expansion ratio is understood to be the ratio of the diameter (or area) offrame 12 between an expanded configuration and a collapsed configuration. Increasing the expansion ratio may allowframe 12 to be collapsed to a generally small profile and still be capable of expanding to conform to the size of a blood vessel. These and other features may allowframe 12 to be delivered with a small profile. - Struts or
ribs 18 may be pre-curved during manufacturing to include a firstcurved portion 24. Whenframe 12 is collapsed within a delivery sheath, stress onframe 12 may longitudinally deform orstrain frame 12.Curved portion 24 has a constant radius so that whenframe 12 is collapsed, stress and/or strain forces are evenly distributed longitudinally throughoutframe 12. According to this embodiment, the peak strain within struts 18 and/orframe 12 whenframe 12 may be minimized by includingcurved portion 24. -
Struts 18 andcrown portion 22 may be continuous and be joined by a secondcurved portion 26. Similarly tocurved portion 24,portion 26 is also curved to minimize peak strain nearcrown portion 26. However, the radius of curvature ofcurved portion 26 may be variable or include portions where the radius varies. In addition,crown portion 22 extends between adistal end 28 and a plurality of strut intersection points 30.Struts 18 may extend frompoints 30 and be coupled toguidewire 20. - It should be noted that the number of
struts 18 and points 30 can be altered without departing from the scope of the present invention. For example,frame 12 may include two, three, four, five, six, or more points. It is believed that increasing the number ofstruts 18 and/or points 30 would decrease the expansion ratio offrame 12. For example, increasing the number ofpoints 30 from four to six would increase the inside diameter offrame 12. Different diameter sizes may be favored when performing an intravascular procedure within different blood vessels. -
FIG. 3 is a flattened plan view of distalprotection filter frame 12. When manufacturingframe 12 it may be beneficial to first manufacture a planer version of the appropriate material (e.g., nickel-titanium alloy). The planer version may be formed into the desired shape by disposingframe 12 about a mandrel (examples are shown below inFIGS. 6-9 ) and coupling opposite ends together, for example by soldering or welding. -
FIG. 4 is a perspective view of analternate filter frame 112 for use with distalprotection filter material 14.Frame 112 is essentially the same in form and function asframe 12 in thatframe 112, except thatframe 112 further comprises distally-orientedstruts 132 in addition to struts 118. Distally-orientedstruts 132 extend distally betweendistal end 128 ofcrown portion 122 andguidewire 20. -
Struts 132 provide additional support forfilter material 14. According to this embodiment, whenframe 12 is coupled to filtermaterial 14, struts 132 may be adapted and configured to follow the contour offilter material 14 and provide structural support along the length thereof. At a distal end, struts 132 may be coupled to the distal end offilter material 14 and/or be coupled toguidewire 20. Similarly toFIG. 3 ,FIG. 5 is a flattened planview filter frame 112. -
FIG. 6 is a perspective view of amandrel 34 for use in manufacturing a distal protection filter frame (e.g.,frame 12 and frame 112).Mandrel 34 includes a generally tapered or cone-likedistal region 36, amiddle region 38, and a taperedproximal region 40. In addition,mandrel 34 may include adistal tip 42 and aproximal tip 44 disposed proximate their respective regions. It should be appreciated that although the subsequent discussion is focused uponframe 12 it is similarly applicable to frame 112 -
Middle region 38 includesgrooves 46 adapted and configured for holding at least a portion offilter frame 12.Grooves 46 are curved such that disposingcrown portion 22 withingrooves 46 may lead to the formation of secondcurved portion 26. In addition, the transition from the relatively straightmiddle region 38 to the taperedproximal region 40 may lead to the formation of firstcurved portion 24, although pre-curving may be desirable if the transition betweenproximal region 40 andmiddle region 38 bends more sharply than desired. - In use, the planer configurations shown in
FIGS. 3 and 5 of frame 12 (and/or frame 112) may be disposed aboutmandrel 34 such thatcrown portion groove 46.Struts 18 may extend betweenmiddle region 38 andproximal region 40 wherein the transition between regions tapers struts 18 toward the center and can be used to formfirst curve 24. The proximal ends ofstruts 18 may be disposed nearproximal tip 44 where they may be coupled toguidewire 20. Acollar 47 may be slidably disposed alongmiddle region 38 that is adapted and configured to be slid overstruts 18 and/or crown portion 22 (or crown portion 122) to holdframe 12 in position. Once held in position, the shape offrame 12 may be set to conform to the shape of the mandrel using methods described below or those known in the art. Following shape setting,frame 12 can be removed frommandrel 34 or it may be coupled withfilter material 14, for example by dippingdistal region 36 into molten or partiallymolten filter material 14. - Heat setting may be used to set the shape of frame 12 (and frame 112). For example,
frame 12 may be comprised of a shape memory alloy that can be heat set. Thus,frame 12 may be disposed aboutmandrel 34 and heated to set the shape offrame 12 to conform to the shape ofmandrel 34. According to this embodiment, mandrel 34 (and subsequently described mandrels) may be comprised of materials that would resist heat deformation such as stainless steel. Once heat set,frame 12 deformed to an alternate shape will return to the heat set shape after force used to deformframe 12 is removed. It may be desirable to heat setframe 12 in the expanded configuration such that delivery offilter 10 from within a relatively small delivery sheath permitsframe 12 to self-expand when the delivery sheath is withdrawn. - It should be noted that
mandrel 34 may be hollow such thatguidewire 20 may pass therethrough with opposing end extending fromdistal tip 42 andproximal tip 44. This embodiment may simplify the process of coupling struts 18 (or struts 132) to guidewire 20 if desired by establishing proper alignment. This step may similarly achieved independently ofmandrel 34. - When used for
frame 112, the above steps occur analogously to what is described above. In addition, struts 132 extend betweenmiddle region 38 anddistal region 36 whereinstruts 132 taper toward the center. The distal ends ofstruts 132 may be disposed neardistal tip 42 where they may be coupled toguidewire 20. - Once
frame filter material 14 may be coupled thereto. For example, suitable filter materials may be molten or partially molten andframe material 14 by dipping distal region 36 (or 136) into thesuitable filter materials 14 as described above. It should be appreciated that a person of ordinary skill in the art would be familiar with suitable filter materials and method forcoupling filter material 14 to frame 12. -
FIG. 7 is a perspective view of analternate mandrel 134 for use in forming a distal protection filter frame.Mandrel 134 is similar tomandrel 34 in that it includesdistal region 136,middle region 138,proximal region 140,distal tip 142, andgrooves 146. In addition,middle region 138 ofmandrel 134 include one ormore openings 148 to aguidewire channel 150.Openings 148 may be used for shaping struts or be a place for struts to extending during formation of the filter frame. According to this embodiment, a filter frame may be configured such that struts orribs 18 pass throughopenings 148, into astrut channel 152 and come together at an apex 154.Openings 148 may be useful for taperingstruts 18 towardguidewire 20. Other than the differences noted above, use ofmandrel 134 may be similar to that ofmandrel 34.FIG. 8 is a cross sectional view taken through line 7-7 of the mandrel shown inFIG. 7 showing channels 152. -
FIG. 9 is a perspective view of a secondalternate mandrel 234 for use in forming a distal protection filter frame.Mandrel 234 is similar tomandrel 34 in form and function in that it includesdistal region 236,middle region 238,proximal region 240,distal tip 242, andgrooves 246. In addition,middle region 238 ofmandrel 234 includes ascrew dip rod 256. -
Filter frame 112 may be coupled tomandrel 234 such thatcrown portion 122 is disposed aboutmiddle region 238 and struts 132 are disposed withingrooves 246 and extend towarddistal tip 242.Screw dip rod 256 may be actuated so as to pass over and hold or set the shape ofcrown portion 122 into a generally circular configuration. Then, heat may be used to set the shape similarly to what is described above.Struts 132 may be coupled toguidewire 20 that may pass throughmandrel 234 and exit therefrom atdistal tip 242.Filter material 14 may be formed in a manner similar to what is described above. - It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the invention. The invention's scope is, of course, defined in the language in which the appended claims are expressed.
Claims (1)
1. A method of manufacturing a distal protection filter assembly, comprising the steps of:
providing a filter frame having a plurality of struts and a mouth;
providing a mandrel having a proximal region, a middle region, and a distal region, the middle region include a groove;
coupling the filter frame to the mandrel wherein the mouth is at least partially disposed within the groove;
coupling a filter to at least a portion of the filter frame.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US11/276,566 US20060130332A1 (en) | 2002-03-13 | 2006-03-06 | Filter frame |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US10/099,219 US7029440B2 (en) | 2002-03-13 | 2002-03-13 | Distal protection filter and method of manufacture |
US11/276,566 US20060130332A1 (en) | 2002-03-13 | 2006-03-06 | Filter frame |
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US10/099,219 Continuation US7029440B2 (en) | 2002-03-13 | 2002-03-13 | Distal protection filter and method of manufacture |
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US11/276,566 Abandoned US20060130332A1 (en) | 2002-03-13 | 2006-03-06 | Filter frame |
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Application Number | Title | Priority Date | Filing Date |
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US10/099,219 Expired - Lifetime US7029440B2 (en) | 2002-03-13 | 2002-03-13 | Distal protection filter and method of manufacture |
Country Status (3)
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US (2) | US7029440B2 (en) |
AU (1) | AU2003213710A1 (en) |
WO (1) | WO2003077798A1 (en) |
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Also Published As
Publication number | Publication date |
---|---|
AU2003213710A1 (en) | 2003-09-29 |
US7029440B2 (en) | 2006-04-18 |
US20030176885A1 (en) | 2003-09-18 |
WO2003077798A1 (en) | 2003-09-25 |
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Owner name: BOSTON SCIENTIFIC SCIMED, INC., MINNESOTA Free format text: CHANGE OF NAME;ASSIGNOR:SCIMED LIFE SYSTEMS, INC.;REEL/FRAME:018505/0868 Effective date: 20050101 Owner name: BOSTON SCIENTIFIC SCIMED, INC.,MINNESOTA Free format text: CHANGE OF NAME;ASSIGNOR:SCIMED LIFE SYSTEMS, INC.;REEL/FRAME:018505/0868 Effective date: 20050101 |
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