WO2003094792A1 - Perfusion guidewire in combination with a distal filter - Google Patents
Perfusion guidewire in combination with a distal filter Download PDFInfo
- Publication number
- WO2003094792A1 WO2003094792A1 PCT/US2003/011298 US0311298W WO03094792A1 WO 2003094792 A1 WO2003094792 A1 WO 2003094792A1 US 0311298 W US0311298 W US 0311298W WO 03094792 A1 WO03094792 A1 WO 03094792A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- filter
- accordance
- coupling member
- space
- elongate shaft
- Prior art date
Links
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
- A61F2/013—Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
-
- 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
- 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
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
Definitions
- the present invention generally relates to perfusion guidewires. More particularly, the present invention relates to perfusion guidewires used in combination with a distal protection device.
- 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 to the heart, which has significant consequences since the heart muscle must be well oxygenated 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.
- the stenotic lesion may be mechanically cut away from the blood vessel wall using an atherectomy catheter.
- stenotic debris can be separated from the wall of the blood vessel.
- this debris enters the circulatory system, it could block other vascular regions including the neural and pulmonary vasculature, both of which are highly undesirable.
- An occlusion in the neural vasculature may cause a stroke, and an occlusion in the lungs may interfere with the oxygenation of the blood.
- 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 a refinement to distal protection devices.
- an embodiment of the present invention comprises a filter coupled to an elongate shaft by a coupling member.
- the coupling member is designed to limit coagulation of blood near the junction of the guidewire and the distal protection device.
- An embodiment of the invention comprises an elongate shaft having a filter disposed proximate a distal end thereof.
- the filter may include devices generally adapted to prevent debris from traveling away from a treatment site during or after an intravascular procedure.
- the filter has at least one opening that may allow the passage of blood and substantially prevent debris (e.g., debris produced by an angioplasty or atherectomy procedure) from flowing therethrough.
- the filter may be coupled to the elongate shaft by a coupling member.
- the coupling member may comprise a coil that is disposed about the elongate shaft. At least a portion of the coil may be coupled to the elongate shaft.
- An alternate coupling member may comprise a porous tube having a proximal end and a distal end.
- the coupling member may be coupled to the elongate shaft and provide spaces and/or opening that permits blood flow but substantially prevent debris from passing therethrough. According to this embodiment, allowing blood through the coupling member will minimize coagulation and clotting of blood proximate the coupling member. To further limit coagulation and clotting, the coupling member, the distal protection device, and the shaft may be treated with an anti-coagulation agent.
- Figure 1 is a partial cross sectional view of a distal protection filter
- Figure 2 is a cross sectional view of the coupling member of the filter shown in Figure 1;
- Figure 3 is a cross sectional view of the coupling member attached to the elongate shaft in at an alternative manner
- Figure 4 is a cross sectional view of the coupling member attached to the elongate shaft in at a second alternative manner
- Figure 5 is a partial cross sectional view of a distal protection filter having an alternate coupling member.
- FIG. 1 is a partial cross sectional view of a distal protection filter 10.
- Distal protection filter 10 includes a filter frame 12 coupled to an elongate shaft 14 by a perfusion coupling member 16.
- Filter 10 may be used to filter debris from a blood vessel in conjunction with a medical procedure that produces embolic debris (e.g., angioplasty, atherectomy, etc.).
- Coupling member 16 may serve to minimize thrombus formation near the junction of filter frame 12 and shaft 14 by allowing fluid to perfuse therethrough.
- Filter frame 12 may be disposed proximate a distal end 18 of shaft 14.
- a filter material 20 having at least one opening 22 may be coupled to frame 12.
- Filter material 20 may be constructed of a polyurethane sheet, and openings 22 may be formed in the polyurethane sheet by known laser techniques. 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 mouth portion 24 a distal end 26. Distal end 26 can be narrow and/or generally "V'-shaped. Filter 10 operates between a closed collapsed profile and an open radially-expanded deployed profile for collecting debris in a body lumen.
- Frame includes a plurality of longitudinally-extending struts 28 extending from mouth portion 24. Struts 28 may be coupled to elongate shaft 14 by a strut coupling 30.
- Elongate shaft 14 may be a guidewire that is generally metallic.
- shaft 14 may be comprised of stainless steel, super elastic alloys (e.g., nitinol), or other suitable materials.
- shaft 14 may be comprised of a polymer or a metal-polymer composite.
- a distal spring tip 32 may be disposed at distal end 18. It can be appreciated that elongate shaft 14 could include an intravascular catheter, a tube having a lumen, an intravascular device, etc.
- Coupling member 16 may comprise a coil that is disposed about elongate shaft 14. It should be noted that the coil of coupling member 16 is depicted in Figure 1 (as well as analogous coils in Figure 2-4) in cross-section and, thus, appears as a plurality of circles.
- Filter 10 may be coupled to coupling member by any one of a number of methods. For example, filter 10 may be heat bonded to the coil. Alternatively, filter 10 may be coupled to coupling member by adhesive, solder, crimping, or other suitable methods.
- At least a portion of the coil is attached to elongate shaft 14.
- the coil may be attached to elongate shaft 14 at a position that is located distally of distal end 26 of filter frame 12 ( Figure 2).
- the coil may be coupled to elongate shaft 14 at a position that is near distal end 26 ( Figure 3).
- the coil may be further coupled to elongate shaft 14 at a location distal of distal end 26.
- the coil may be coupled to elongate shaft 14 at multiple locations along the length of elongate shaft 14 ( Figure 4).
- Figure 2 is a cross sectional view of coupling member 16 wherein coupling member 16 is coupled to elongate shaft 14 at a location that is distal of distal end 26 of filter frame 12.
- distal end 26 of filter frame 12 may be a first distance 34 away from elongate shaft 14.
- First distance 34 and the width of openings 22 within filter material 20 are approximately equal.
- First distance 34 defines a space between coupling member 16 and elongate shaft 14 to permit blood flow therethrough.
- the coil of coupling member 16 has a relatively open pitch that defines a second distance 36 between individual winding of the coil. According to this embodiment, blood can flow through a space between the windings of the coil in a generally circular direction that follows the coil. Second distance 38 may be approximately equal to the width of openings 22. In an exemplary embodiment, first distance 34, second distance 36, and the width of openings 22 are all approximately equal.
- coupling member 16 will pass between coupling member 16 and shaft 14 through spaces therebetween and/or spaces between the individual winding of the coil. Permitting blood flow through coupling member 16 will minimize coagulation and clotting of blood proximate coupling member 16.
- coupling member 16, filter material 20, elongate shaft 14, etc. may be treated with an anti-coagulation agent.
- An anti-coagulation agent may include substances including, but not limited to, silicon, anti-coagulants, warfarin, nicoumalone, phenindione, heparin, low-molecular-weight heparins, anti- thrombin agents, dermatan sulfate, hirugen, argatroban, peptide chloromethyl ketone inhibitors, ancrod, anti-platelet agents, aspirin, epoprostenol, prostacyclin, ticlopidine, antibodies against the GPIIb/IIIa (glycoprotein Ilb/IIIb) receptor, TXA2 (thromboxane A2) synthesis inhibitors, TXA2 receptor antagonists, anti-fibrinolytic agents, tranexamic acid, aprotinin, ethamsylate, and combinations thereof.
- substances including, but not limited to, silicon, anti-coagulants, warfarin, nicoumalone, phenindione, heparin, low-molecular-weight
- FIG. 3 is a cross sectional view of coupling member 16 attached to elongate shaft 14 at both a location distal of distal end 26 and a location proximal of distal end 26. This additional attachment point between coupling member 16 and shaft 14 may more securely couple filter frame 12 to shaft 14. In addition, blood flow will be permitted along the windings of the coil and through the space between the coil and shaft 14.
- Figure 4 is a cross sectional view of coupling member 16 attached to elongate shaft 14 at multiple locations. According to this embodiment, the lack of spacing between frame 12 and shaft 14, will limit blood flow to being through winding of the coil. Securing coupling member 16 to shaft 14 at multiple locations may further strengthen the bond between frame 12 and shaft 14.
- FIG. 5 is a partial cross sectional view of an alternate coupling member 116.
- Coupling member 116 may comprise a porous tube 138 having a proximal end 140 and a distal end 142 and is disposed over a portion of elongate shaft 14 a distance (analogous to first distance 34) away from shaft 14. The distance between tube 138 and shaft 14 defines a space therebetween.
- Porous tube 138 may further comprise a first opening 144 near proximal end 140 and a second opening 146 near distal end 142.
- Filter frame 12 may be coupled to porous tube 138 between first opening 144 and second opening 146.
- the width of first opening 144 and second opening 146 may be approximately equal to the width of openings 22 in filter material 20.
- First opening 144 and second opening 146 are in fluid communication with one another through the space defined between shaft 14 and tube 138. It can be appreciated that porous tube 138 may include additional openings. Similar to what is disclosed above, first opening 144 and second opening 146 may permit flow of blood but substantially prevent debris from flowing therethrough that might occlude a blood vessel.
- blood may enter first opening 146, migrate distally (i.e., toward distal end 18 of elongate shaft 14) within the space between shaft 14 and tube 138, and exit porous tube 138 through second opening 146. Allowing blood to pass through tube 138 may limit coagulation and clotting of blood proximate coupling member 316.
- coupling member 116 may be treated with substances including anticoagulants, anti-thrombin agents, anti-platelet agents, anti-fibrinolytic agents, etc.
- a method for filtering debris for a blood vessel in disclosed that utilizes any of the devices listed above.
- the method comprises the steps of providing elongate shaft 14 including filter 10 coupled thereto, positioning elongate shaft 14 within a blood vessel downstream of a medical procedure that may generate debris (e.g., angioplasty, atherectomy, etc.), collecting the debris with filter material 20, and allowing blood to flow through coupling member 16 (and/or coupling member 116).
- the method may also include the step of treating any of the above elements with an anti-coagulation agent.
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU2003221906A AU2003221906A1 (en) | 2002-05-06 | 2003-04-11 | Perfusion guidewire in combination with a distal filter |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/140,404 US7060082B2 (en) | 2002-05-06 | 2002-05-06 | Perfusion guidewire in combination with a distal filter |
US10/140,404 | 2002-05-06 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2003094792A1 true WO2003094792A1 (en) | 2003-11-20 |
Family
ID=29269670
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2003/011298 WO2003094792A1 (en) | 2002-05-06 | 2003-04-11 | Perfusion guidewire in combination with a distal filter |
Country Status (3)
Country | Link |
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US (2) | US7060082B2 (en) |
AU (1) | AU2003221906A1 (en) |
WO (1) | WO2003094792A1 (en) |
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Also Published As
Publication number | Publication date |
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AU2003221906A1 (en) | 2003-11-11 |
US7785344B2 (en) | 2010-08-31 |
US20060195138A1 (en) | 2006-08-31 |
US7060082B2 (en) | 2006-06-13 |
US20030208225A1 (en) | 2003-11-06 |
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