US20070156170A1 - Expandable emboli filter and thrombectomy device - Google Patents
Expandable emboli filter and thrombectomy device Download PDFInfo
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- US20070156170A1 US20070156170A1 US11/654,757 US65475707A US2007156170A1 US 20070156170 A1 US20070156170 A1 US 20070156170A1 US 65475707 A US65475707 A US 65475707A US 2007156170 A1 US2007156170 A1 US 2007156170A1
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- filtering device
- elongate member
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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
- A61F2/0105—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
- 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
- A61F2002/016—Filters implantable into blood vessels made from wire-like elements
-
- 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
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0065—Three-dimensional shapes toroidal, e.g. ring-shaped, doughnut-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
- A61F2230/0069—Three-dimensional shapes cylindrical
-
- 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
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- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
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Abstract
Expandable emboli filter and thrombectomy devices adapted for use with microcatheters to remove debris from blood vessels. The devices embody expanded profiles that span the entirety of various sized target vessels and thus are particularly effective in the engagement of debris found in vessels.
Description
- The present invention relates generally to filtering and thrombectomy devices and systems which can be used to capture embolic material or thrombi found in blood vessels. The filtering devices and systems of the present invention are particularly useful when performing balloon angioplasty, stenting procedures, laser angioplasty or atherectomy in critical vessels where the release of embolic debris into the bloodstream can occlude the flow of oxygenated blood to the brain or other vital organs, which can cause devastating consequences to the patient. The thrombectomy devices are suited for the removal of thrombus in a variety of vessels. While the embolic filtering and thrombectomy devices and systems of the present invention are particularly useful in the cerebral vasculature and neurovasculature, the inventions can be used in conjunction with any vascular interventional procedure in which there is an embolic risk.
- A variety of non-surgical interventional procedures have been developed over the years for opening stenosed or occluded blood vessels in a patient caused by the build up of plaque or other substances on the wall of the blood vessel. Such procedures usually involve the percutaneous introduction of the interventional device into the lumen of the artery, usually through a catheter. In typical PTA procedures, a guiding catheter or sheath is percutaneously introduced into the cardiovascular system of a patient through the femoral artery and advanced to near the target vasculature. A guidewire and a dilatation catheter having a balloon on the distal end are introduced through the guiding catheter with the guidewire sliding within the dilatation catheter. The guidewire is first advanced out of the guiding catheter into the patient's vasculature and is directed across the arterial lesion. The dilatation catheter is subsequently advanced over the previously advanced guidewire until the dilatation balloon is properly positioned across the arterial lesion. Once in position across the lesion, the expandable balloon is inflated to a predetermined size with a radiopaque liquid at relatively high pressures to radially expand the atherosclerotic plaque of the lesion and thereby dilate the lumen of the artery. The balloon is then deflated to a small profile so that the dilatation catheter can be withdrawn from the patient's vasculature and the blood flow resumed through the dilated artery. As should be appreciated by those skilled in the art, while the above-described procedure is typical, it is not the only method used in angioplasty. Another procedure is laser angioplasty which utilizes a laser to ablate the stenosis by super heating and vaporizing the deposited plaque. Atherectomy is yet another method of treating a stenosed blood vessel in which cutting blades are rotated to shave the deposited plaque from the arterial wall. A vacuum catheter is usually used to capture the shaved plaque or thrombus from the blood stream during this procedure.
- In the procedures of the kind referenced above, abrupt reclosure may occur or restenosis of the artery may develop over time, which may require another angioplasty procedure, a surgical bypass operation, or some other method of repairing or strengthening the area. To reduce the likelihood of the occurrence of abrupt reclosure and to strengthen the area, a physician can implant an intravascular prosthesis for maintaining vascular patency, commonly known as a stent, inside the artery across the lesion. The stent is crimped tightly onto the balloon portion of the catheter and transported in its delivery diameter through the patient's vasculature. At the deployment site, the stent is expanded to a larger diameter, often by inflating the balloon portion of the catheter.
- Prior art stents typically fall into two general categories of construction. The first type of stent is expandable upon application of a controlled force, as described above, through the inflation of the balloon portion of a dilatation catheter which, upon inflation of the balloon or other expansion means, expands the stent to a larger diameter to be left in place within the artery at the target site. The second type of stent is a self-expanding stent formed from, for example, shape memory metals or super-elastic nickel-titanum (NiTi) alloys, which will automatically expand from a compressed state when the stent is advanced out of the distal end of the delivery catheter into the body lumen. Such stents manufactured from expandable heat sensitive materials allow for phase transformations of the material to occur, resulting in the expansion and contraction of the stent.
- The above minimally invasive interventional procedures, when successful, avoid the necessity of major surgical operations. However, there is one common problem which can become associated with all of these types of procedures, namely, the potential release of embolic debris into the bloodstream that can occlude distal vasculature and cause significant health problems to the patient. For example, during deployment of a stent, it is possible that the metal struts of the stent can cut into the stenosis and shear off pieces of plaque which become embolic debris that can travel downstream and lodge somewhere in the patient's vascular system. Pieces of plaque material can sometimes dislodge from the stenosis during a balloon angioplasty procedure and become released into the bloodstream. Additionally, while complete vaporization of plaque is the intended goal during a laser angioplasty procedure, quite often particles are not fully vaporized and thus enter the bloodstream. Likewise, not all of the emboli created during an atherectomy procedure may be drawn into the vacuum catheter and, as a result, enter the bloodstream as well.
- When any of the above-described procedures are performed in the vessels supplying blood to the brain, the release of emboli into the circulatory system can be extremely dangerous and sometimes fatal to the patient. Naturally occurring debris can also be highly dangerous to a patient. That is, debris which travels through the blood vessel as a natural result of bodily functions or disease states and not as a result of an intervention procedure. Debris that is carried by the bloodstream to distal vessels of the brain can cause these cerebral vessels to occlude, resulting in a stroke, and in some cases, death. Therefore, although cerebral percutaneous transluminal angioplasty has been performed in the past, the number of procedures performed has been limited due to the justifiable fear of causing an embolic stroke should embolic debris enter the bloodstream and block vital downstream blood passages.
- Medical devices have been developed to attempt to deal with the problem created when debris or fragments that naturally occur or that enter the circulatory system following vessel treatment utilizing any one of the above-identified procedures. One approach which has been attempted is the cutting of any debris into minute sizes which are unlikely to occlude major vessels within the patient's vasculature. However, it is often difficult to control the size of the fragments which are formed, and the potential risk of vessel occlusion still exists, making such a procedure in the carotid arteries a high-risk proposition.
- Other techniques which have been developed to address the problem of removing embolic debris include the use of catheters with a vacuum source which provides temporary suction to remove embolic debris from the bloodstream. However, as mentioned above, there have been complications with such systems since the vacuum catheter may not always remove all of the embolic material from the bloodstream, and a powerful suction could injure the patient's vasculature or remove more blood than is safe. Other techniques which have had some limited success include the placement of a filter or trap downstream from the treatment site to capture embolic debris before it reaches the smaller blood vessels downstream. However, there have been problems associated with conventional filtering systems. In particular, certain previously developed filtering devices do not optimize the area for embolic collection. That is, conventional filtering devices may not present a collection device that spans the entity of the vessel or it may include supporting structure that itself impedes emboli collection. Certain other devices are not effective when used in conjunction with a microcatheter.
- Moreover, thrombectomy and foreign matter removal devices have been disclosed in the art. However, such devices have been found to have structures which are either highly complex or lacking in sufficient or effective expansion and retraction capabilities. Disadvantages associated with the devices having highly complex structure include difficulty in manufacturability as well as use in conjunction with microcatheters. Other less complex devices can pull through clots due to in part the lack of experience in using the same, or lack an adequately fine mesh for capturing clots or foreign bodies.
- Furthermore, systems heretofore disclosed in the art are generally limited by size compatibility and the increase in vessel size as the emboli is drawn out from the distal vascular occlusion location to a more proximal location. If the thrombectomy device is too large for the vessel it will not deploy correctly to capture the clot or foreign body, and if too small in diameter it cannot capture thromboembolic material or foreign bodies across the entire cross section of the blood vessel. Thus, a thrombectomy device that can be expanded to a relatively large diameter from a relatively small diameter is desirable as is the ability to effectively control such expansion and contraction.
- What has been needed is a reliable filtering or thrombectomy device and system for use when treating blood vessels. The filter devices should be capable of filtering any naturally occurring embolic debris or that which may be released into the bloodstream during an interventional treatment, while minimizing the area occupied by structure supporting the filter so as to minimally obstruct blood flow, and safely contain the debris until the filtering device is removed from the patient's vasculature. The thrombectomy devices should embody an expanded profile that completely occupies the vessel at the repair site as well as structure for effectively expanding and retracting the device. Moreover, such devices should be relatively easy to deliver through a microcatheter, as well as be deployed and removed from the patient's vasculature and also should be capable of being used in narrow and very distal vasculature such as the cerebral vasculature. The following invention addresses these needs.
- Briefly and in general terms, the present invention is directed toward expandable devices for repairing blood vessels. The expandable devices are particularly suited for removing emboli or thrombi from the bloodstream of a human or animal. One significant advantage provided by the present invention is the potential use of the expandable devices in narrow and very distal vasculature.
- In one aspect of the invention, there is provided a loop with an embolic filter attached thereto. The loop is configured to self-expand generally perpendicularly to and optionally offset to a longitudinal axis of a delivery catheter. A tether is provided to effect the deployment from and withdrawal into the delivery catheter. The self-expandable loop and filter structure advantageously expands to occupy the entire cross-section of the lumen into which it is deployed. When the device is in its expanded configuration, the shape of the loop is defined by the lumen and the tether is positioned near a wall of the lumen.
- In another aspect, the present invention includes multiple loops that are connected by longitudinally extending fibers. The connecting fibers may be crossing or non-crossing and may terminate at a superior loop or continue distally to define a tapered distal end. A catheter is provided for deploying the double loop device as is a tether which effectuates the delivery and withdrawal of the device. The multiple loops are intended to self-expand to occupy the entirety of the cross-section of the blood vessel into which it is deployed, the loops assuming the geometry of the vessel. Additionally, when the device is in its expanded configuration, the tether is intended to generally lie adjacent a wall defining the lumen thereby accomplishing less blood flow obstruction. The distal loops may also provide internal support for an embolic filter, facilitating material entry into the filter.
- In a third aspect of the invention, an embolectomy snare is provided which has the advantage of being able to assume a very small profile when packed within a delivery catheter. The embolectomy snare is characterized by including a basket that is formed from non-overlapping elongate members.
- In a fourth aspect of the invention, improved expansion control and a means for optimizing expansion profiles is incorporated into a thrombectomy device. In particular, one or more stops are provided on an elongate member to cause a basket-like thrombectomy device configured coaxially about the elongate member to thereby open and close the basket. By varying the weave pattern of the basket of the thrombectomy device, upon expansion of the same, a concavity can be formed, the same being particularly useful for engaging and removing clots from a blood vessel.
- These and other objects and advantages of the invention will become apparent from the following more detailed description, when taken in conjunction with the accompanying drawings of illustrative embodiments.
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FIG. 1A is a perspective view, partially in cross-section, of an expandable device of the present invention in its deployed configuration; -
FIG. 1B is a perspective view, depicting a loop and an expandable device that is integral with an elongate member; -
FIG. 2A is a perspective view, partially in cross-section, of an alternate embodiment of the present invention in its deployed configuration; -
FIG. 2B is a perspective view, depicting a loop configured with mini-loops for spacing tethers; -
FIG. 3 is a perspective view of another embodiment of an expandable device of the present invention in its expanded configuration; -
FIG. 4A is a perspective view of yet another embodiment of an expandable device of the present invention in its expanded configuration; -
FIG. 4B is a perspective view, depicting an expandable device of the present invention with a medical loop; -
FIG. 5A is a side view of an emboli snare of the present invention shown in its expandable state; -
FIG. 5B is a cross-sectional view taken along B-B of the device shown inFIG. 5A ; -
FIG. 6 is a cross-sectional view of the device depicted inFIG. 5A when withdrawn within a delivery catheter; -
FIG. 7 is a side view of a thrombectomy device of the present invention shown in its fully contracted configuration; -
FIG. 8 is a side view of the device depicted inFIG. 7 advanced distally with respect to an elongate member; -
FIG. 9 is a side view of the device depicted inFIG. 8 which is further advanced distally and placed in an expanded configuration; and -
FIG. 10 is a side view of the device depicted inFIG. 9 in its fully expanded configuration. - Turning now to the drawings, and particularly to
FIG. 1A , there is shown anexpandable device 20 of the present invention. Theexpandable device 20 is suited for repairing vessels and in particular, for capturingemboli 22 found in the bloodstream of a patient. Due to its novel structure, therepair device 20 embodies an expanded profile that is highly effective in filtering unwanted material from vasculature and is capable of being deployed within very narrow and distal vasculature, including the cerebral vasculature. - In one presently preferred embodiment, the
expandable device 20 includes aloop 24 attached by conventional means to adistal end 26 of anelongate member 28. Attached to theloop 24 is anemboli filter 30. Theloop 24 can be soldered to theelongate member 28 or can be affixed thereto using epoxy or other forms of adhesive. Alternatively, theloop 24 can be an integral part of the elongate member 28 (SeeFIG. 1B ). A band or other mechanical fixation devices (not shown) could also be used for this purpose. The emboli filter 30 could be attached to theloop 24 using a plurality of proximally extending anchors orfibers 32, each of which are configured intosmall hoops 34 that engage theloop member 24. - An elongate,
tubular catheter 36, preferably a microcatheter or otherwise a lumen of a conventional stent delivery catheter, is also provided. Themicrocatheter 36 includes aninternal bore 38 that is adapted to coaxially and slidably receive theelongate member 28 as well as the loopedmember 24 and emboli filter 30 assembly. Thedelivery catheter 36 is capable of being manipulated independent of theelongate member 28 and loop/filter assembly, for example, by holding thedelivery catheter 36 in a particular longitudinal position while advancing theelongate member 28. Alternatively, thedelivery catheter 36 can be withdrawn or advanced while maintaining a desired longitudinal position of theelongate member 28. - The
loop 24 is preferably made from a looped length of superelastic wire. Theelongate member 28 can be formed from a guide wire. - Significantly, the
loop 24 is configured so that when it exits thedistal end 40 of thedelivery catheter 36, theloop 24 projects generally perpendicularly to longitudinal axes of theelongate member 28 andcatheter 36. It is also contemplated, that for particular purposes, theloop 24 could project at an acute or obtuse angle respecting theelongate member 28. Accordingly, it is contemplated that the loop 21 also embodies shape retaining material and a material that permits theloop 24 to quickly and repeatedly return to a desirable pre-formed shape. - It is also highly significant that the
loop 24 embodies sufficient flexibility so that upon ejection from thedelivery catheter 36, theloop 24 generally conforms to an inside circumference of ablood vessel 42 into which it is deployed. In doing so, theelongate member 28 anddistal portion 40 of thedelivery catheter 36 are generally positionedadjacent walls 44 defining an interior lumen of theblood vessel 42. Thus, theexpandable loop 24 spans the entirety of the circumference of thevessel 42. Moreover, theelongate member 28 anddelivery catheter 36 are advantageously displaced from the center or median of the bloodflow, such that debris traveling through the vessel can avoid these components and must pass through theloop 24. - In an alternative embodiment (
FIG. 2A ), theloop 24 can embody a plurality ofmembers 46, preferably two such members, entwined about each other. The twinedconfiguration 46 advantageously embodies additional hoop strength without sacrificing the other advantages of the loop configuration such as the ability to assume the contour of the interior 44 of theblood vessel 42. The twined configuration also provides structure for maintaining a desired spacing between anchors orfibers 32 which are used to attach thefilter 32 to theloop 24. Further, rather than relying on an interference fit between thehoops 34 and theloop 24 to accomplished desired spacing, theanchors 32 can embody single mini-loops which encircle one of the twinedmembers 46. In yet another aspect of the invention, theloop 24 can embody mini-loops 47 that serve to correctly space the tethers 32 (SeeFIG. 2B ). - The
filter 30 includes a proximally directedopening 48 to an interior 50. Thebody 52 of thefilter 30 can have any exterior profile but it is preferred that its exterior generally assume a hemispherical or conical shape. The fully expandedfilter 30 has anopening 48 to thebody 52 that is generally circular but can be modified for a particular application. In one preferred embodiment, thebody 52 is made from a mesh-fabric material through which blood can readily flow. The mesh contains apertures or pores 54 through which the blood passes but which are small enough so that debris does not flow therethrough. Alternatively, the filter can embody laser cut mylar or is defined by ultrasonically welded polymer fibers. In yet another aspect, the fiber crossing can be bonded with flexible adhesive. - The
filter sub-assembly 30 can be made from surgical mesh or alternatively thefilter 30 can embody a network of braided members or fibers. For example, the filter can embody abraided expansion wire 50. In one presently preferred embodiment, theexpandable device 20 consists of anelongate member 28 or guidewire with a metal braided basket (not shown) attached to a loop or otherwise directly attached to a superior end of the wire. - It is additionally contemplated that, as shown in
FIG. 3 , the weavedbasket 56 may be formed frompolypropylene suture 58. In order to manufacture the weavedbasket 56, thepolypropylene suture 58 is wrapped in an over and under weaving pattern about a mandrel (not shown) which can embody a tapered or straight cylindrical profile. A proximal orinferior end portion 60 includes reversals ofdirection 62. A distal orsuperior end portion 64 is tied to form a closed structure. The tied end is cut to provide an even profile and apolymide tube 66 having the smallest diameter possible is placed about the closed end. Thereafter, an adhesive is applied to retain thepolymide tubing 66 on thebraided basket 56. - A shape set
loop 24 is then threaded through thereversals 62. By doing so, thebraided basket 56 is fixed to theloop 24. In a presently preferred embodiment, thepolypropylene suture 58 has a diameter of 0.003 inches, thepolymide tubing 66 has an inner diameter of 0.0318 inches and an outer diameter of 0.0364 inches, and theloop 24 is formed from 0.003 inch diameter nickel titanium wire. - It is contemplated that in one preferred embodiment the
braided basket 56 comprises an 8-strand pattern that results in a closed net. The length of thebasket 56 will vary depending on the size of the material to be removed. The diameter of thebasket 56 will also vary from 2 mm to 50 mm depending on the lumen diameter of the vessel from which material is to be removed. Thebasket 56 is attached to aloop 24 which opens the proximal end of the basket 51, allowing entry of material into thebasket 56. Theloop 24 may be formed of a variety of elastic 24 or superelastic materials. The diameter of theloop 24 will match that of thebasket 56. Theloop 24 may be covered, in part or in full, with a platinum coil to minimize the potentiality of trauma caused by the device, and/or to enhance attachment of thebasket 56 to theloop 24. The inner diameter of this coil corresponds to the outer diameter of the loop strand, allowing for clearance. A typical coil is 0.009 inches in inner diameter with a wire diameter of .0025 inches. Theloop 24 is attached to theelongate member 28 via soldering and other joining technology. - The
expandable devices 20 advantageously embody a simple structure that can assume a very small contracted profile. Thus, the device can be used in conjunction with aflexible microcatheter 36 that can traverse very narrow, tortuous and distal vasculature. Upon expansion, the self-expandingloop 24 assumes the contour of the vessel into which it is deployed thereby providing an optimized structure for capturing debris. Moreover, when theloop 24 is expanded, themicrocatheter 36 andelongate member 28 lie adjacent a wall defining vessel and substantially out of the way of the flow path. Accordingly, theexpandable device 20 can be used to effectively repair virtually any portion of a patient's vasculature by simply modifying the range of expandedloop 24 sizes. - Referring now to
FIG. 4A , another preferred embodiment of an expandable device is shown. In this embodiment, the present invention is embodied in a dual-looped,expandable device 70. The dual-looped device includes a first or inferiorself expanding loop 72, a second or superior expandingloop 74, each of which are attached to a distal end of an elongate member orwire 28. Highly flexible connectingfibers 76 are routed between the first 72 and second 74 loops to thereby define anemboli receiving cavity 78 when the device is in its expanded configuration. The connectingfibers 76 act as structure for engaging and capturing emboli and can be cross or non-crossing. Additionally, the connectingfibers 76 may embody a single continuous fiber or may include multiple fibers. The fibers may be tied to thesecond loop 74 or they can extend (not shown) beyond thesecond loop 74, tapering off and terminating with a pointed end. - In one preferred embodiment of the dual looped
device 70, theelongate member 28 is comprised of Nitinol and includes a 0.004 inch outer diameter reduced section for receiving portions of theloops loops elongate member 28. The connectingfibers 76 comprise polypropylene strands. Further, in a preferred embodiment, the connectingfibers 76 are routed such that there are five (5) points of connection perloop - The dual-looped
device 70 is also contemplated to be used with a generallytubular delivery catheter 76 that is adapted to slidably receive theelongate member 28 as well as receivecompressed loops loop device 70 also embodies the advantages associated with the single loop design. That is, theloops delivery catheter 36 andelongate member 28 lie adjacent to the vessel wall that is substantially out of the flow path.FIG. 4B depicts another preferred embodiment in which anadditional loop 79 betweenloops - In use, the expandable devices depicted in
FIGS. 1-4 are contemplated to be packed in a compressed state within thetubular delivery catheter 36. Access is gained to the patient's vasculature via conventional methods and the delivery catheter/expandable device assembly is placed within the patient's vasculature. The assembly is then advanced through the patient's vasculature to a repair site and thedistal end 40 of thedelivery catheter 36 is positioned beyond the repair site. Thereafter, theexpandable device delivery catheter 36 so that the expandable device exits the distal end of thedelivery catheter 36, which in turn, allows theexpandable device - As the
expandable device elongate member 28 and theloop 24 orloops filter body 52 is opened by the expansion of theloop 24 and in the case of the dual-loopeddevice 70, the expansion of theloops cavity 78. - Once it is in its fully deployed configuration, the
expandable devices filter body 52 or theemboli receiving cavity 76 and is captured therein. Once the debris is captured, theexpandable device - With reference to
FIG. 5A , there is shown another embodiment of an expandable device of the present invention which is specifically adapted for use as anembolectomy snare device 80. Thesnare device 80 includes a plurality ofshape memory elements 82 that are configured in alternating and generally undulating sections to form a basket structure which defines aninterior pocket 84 and a proximally directed opening thereto (SeeFIG. 5B ).Adjacent elements 82 on one side of the generally conical, basket-like profile may be laser welded or fixed to each other at points of proximity. Aproximal end 88 of the shapedmemory elements 82 is affixed by conventional means to anelongate member 90. Further, thesnare device 80 is contemplated to be used in conjunction with a generallytubular delivery catheter 36 which is adapted to slidably receive theelongate member 90 as well as thebasket 83 in a compressed configuration. - The
snare device 80 advantageously embodies elements which are non-overlapping. To wit,snare device 80 can be packed very tightly within an interior 38 of thedelivery catheter 36 such as a microcatheter. This feature is shown inFIG. 6 , which depicts a cross-sectional view of a snare device loaded within thedelivery catheter 36. Due to its ability to be packed into a very small diameter microcatheter, thesnare device 80 is well-suited for use in narrow and distal vasculature. - In use, the
snare device 80 is placed in its compressed state within adelivery catheter 38 that is advanced within vasculature to a repair site. Thesnare device 80 is then ejected from adistal end 40 of thedelivery catheter 36 and permitted to self-expand within the target vessel. The expandedsnare device 80 is then brought into engagement with embolic material found in the bloodstream. The pocket defined by thebasket profile 83 then receives and captures the embolic material, which is then capable of being removed from a patient's vasculature. - It is also to be recognized, however, that the devices described herein can also be delivered through a guidewire lumen of a balloon or stent catheter. This allows for direct placement without requiring the use of a micro-catheter.
- Turning now to
FIGS. 7-10 , there is shown anexpandable device 100 which concludes anactuating basket 102 defined byelements 103. Theelements 103 are weaved together in a generally helical fashion. Although thisexpandable basket device 100 is primarily intended for use in thrombectomy procedures, the device has applications to the capture of emboli in the bloodstream as well. Thebasket device 100 can be used in conjunction with a microcatheter (not shown) or it can be deployed within vasculature without using a microcatheter. As shown in the figures, thebasket device 100 may be attached to adistal end 104 of an elongate,tubular carrier 106. - A
retainer 108 is provided at adistal end 110 of thebasket device 100. Theretainer 108 has a generally cylindrical profile and includes an internal bore (not shown). Theretainer 108 functions to maintain thedistal end 110 of the basket device in a closed configuration both when thebasket 100 is unexpanded and when it is expanded. - The basket
device assembly device 100 is adapted to be slidably placed about anelongate member 112 in a coaxial arrangement. Theelongate member 112 is likewise received in theretainer 108 in a coaxial arrangement.Elongate member 112 includes a plurality ofbeads 114, the outer profile which is greater than the internal bore of theretainer 108 but smaller than an internal diameter of the elongatetubular member 106. - The
beads 114 have a dual function. A proximally positionedbead 114 is employed, as shown inFIG. 7 to retain thebasket device 100 in a compressed configuration by holding theproximal bead 114 in engagement with aproximal side 116 with aretainer 108. Expansion of thebasket device 100 is achieved by translating thebasket device 100 distally with respect to theelongate member 112 and by causing thedistal side 118 of theretainer 108 to engage a distally positionedbead 114, the further thebasket device 100 is translated distally, the greater the radial expansion. Accordingly, thebasket device 100 can be controllably and repeatedly expanded and contracted to the extent desired to engage vessel walls of varied diameters. It is contemplated that thebasket device 100embody wire elements 102 which have more stiff distal portions than proximal portions so that when the basket continues to expand, aconcavity 120 is formed. Alternatively, theconcavity 120 can be formed if thebasket device 100 is leashed to the elongate tubular member, for example. - As stated, the
basket device 100 can also be used in combination with the microcatheter. In a first step of use, the microcatheter is employed to deliver anelongate wire 112 which includes only asingle bead 114. The microcatheter is then completely withdrawn from a patient's vasculature and abasket device 100 is threaded over theelongate member 112. Once theretainer 108 of thebasket device 100 is advanced sufficiently to engage thebead 114, thebasket device 100 can be made to expand radially outwardly. In the event use of a microcatheter is essential to the specific application, this alternative approach allows for the use of abasket device 100 with an elongate tubular member that has a larger outer diameter than an inner diameter of the microcatheter, which advantageously allows for increased pushability and column strength on theelements 103 defining thebasket portion 102. - In view of the foregoing, it is clear that the expandable devices of the present invention are useful for the repair of vasculature. In particular, the disclosed expandable devices are particularly useful for the capture of emboli as well as for use in thrombectomy procedures.
- It will be apparent from the foregoing that, while particular forms of the invention have been illustrated and described, various modifications can be made without departing from the spirit and scope of the invention. Accordingly, it is not intended that the invention be limited, except by the appended claims.
Claims (21)
1-32. (canceled)
33. An embolic filtering device for capturing embolic debris from the body fluid flowing in a body vessel, comprising:
an elongate member having a distal end portion;
a loop extending from the distal end portion of the elongate member, the loop being movable between a pre-deployment collapsed position and a deployed expanded position in which the loop assumes a specific per-formed shape;
a filter coupled to the loop; and
a generally elongate microcatheter having an internal bore, the microcatheter adapted to receive the elongate member and at least a portion of the loop and filter within the internal bore.
34. The embolic filtering device of claim 33 wherein the loop expands at a generally perpendicular angle to the elongate member when deployed from the microcatheter.
35. The embolic filtering device of claim 33 , wherein the loop assumes a generally circular pre-formed shape when placed in the deployed expanded position.
36. The embolic filtering device of claim 33 , wherein the loop is self-expanding.
37. The embolic filtering device of claim 33 , wherein the loop assumes a generally circular pre-formed shape generally perpendicular to the longitudinal axis of the elongate member when placed in the deployed expanded position.
38. The embolic filtering device of claim 33 , wherein the loop assumes a generally circular pre-formed shape generally at an acute or obtuse angle with perpendicular to the longitudinal axis of the elongate member when placed in the deployed expanded position.
39. The embolic filtering device of claim 33 , wherein the loop is self-expanding and generally conforms to the shape of the inside circumference of the body vessel.
40. The embolic filtering device of claim 37 , wherein the elongate member and microcatheter assume a position contacting the wall of the body vessel when the loop is placed in the deployed expanded position.
41. The embolic filtering device of claim 33 , wherein the loop expands the entirety of the circumference of the body vessel when placed in the deployed expanded position.
42. The embolic filtering device of claim 33 , the filter includes a plurality of mini-loops, the mini-loops adapted for receiving a portion of the loop.
43. The embolic filtering device of claim 33 , the filter further comprising a plurality of proximally extending members, the proximally extending members adapted for receiving at least a portion of the loop.
44. The embolic filtering device of claim 33 , wherein the loop expands the entirety of the circumference of the body vessel when placed in the deployed expanded position.
45. An embolic filtering device for capturing embolic debris from the body fluid flowing in a body vessel, comprising:
an elongate member having a distal end portion;
a loop coupled to the distal end portion of the elongate member, the loop being movable between a pre-deployment collapsed position and a deployed expanded position in which the loop assumes a specific per-formed shape;
a filter coupled to the loop; and
a microcatheter having an internal bore, the microcatheter adapted to receive the elongate member, loop and filter within the internal bore, the microcatheter having an small outer diameter which allows the microcatheter to remain in the body vessel while the filter device.
46. The embolic filtering device of claim 45 , wherein the loop expands at a generally perpendicular angle to the elongate member when deployed from the microcatheter.
47. The embolic filtering device of claim 45 , wherein the loop assumes a generally circular pre-formed shape when placed in the deployed expanded position.
48. The embolic filtering device of claim 45 , wherein the loop is self-expanding.
49. The embolic filtering device of claim 45 , wherein the loop assumes a generally circular pre-formed shape generally perpendicular to the longitudinal axis of the elongate member when placed in the deployed expanded position.
50. The embolic filtering device of claim 45 , wherein the loop assumes a generally circular pre-formed shape generally at an acute or obtuse angle with perpendicular to the longitudinal axis of the elongate member when placed in the deployed expanded position.
51. The embolic filtering device of claim 45 , wherein the microcatheter is steerable into the body vessel.
52. A method for capturing embolic debris in the body fluid flowing in a body vessel, comprising:
providing a filtering device having an elongate member having a distal end portion, a loop extending from the distal end portion of the elongate member, the loop being movable between a pre-deployment collapsed position and a deployed expanded position in which the loop assumes a specific per-formed shape, a filter coupled to the loop and a generally elongate microcatheter having an internal bore, the microcatheter adapted to receive the elongate member and at least a portion of the loop and filter within the internal bore;
introducing the filtering device into the body vessel while the loop is restrained in the pre-deployment collapsed position;
placing the loop into the deployed expanded position;
filtering embolic debris from the body fluid flowing in the body vessel; and
moving the loop at least partial back into the pre-deployment collapsed position; and
removing the filtering device from the body lumen.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/654,757 US20070156170A1 (en) | 2001-01-23 | 2007-01-18 | Expandable emboli filter and thrombectomy device |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US09/768,653 US6610077B1 (en) | 2001-01-23 | 2001-01-23 | Expandable emboli filter and thrombectomy device |
US11/654,757 US20070156170A1 (en) | 2001-01-23 | 2007-01-18 | Expandable emboli filter and thrombectomy device |
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Application Number | Title | Priority Date | Filing Date |
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US09/768,653 Continuation US6610077B1 (en) | 2001-01-23 | 2001-01-23 | Expandable emboli filter and thrombectomy device |
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US20070156170A1 true US20070156170A1 (en) | 2007-07-05 |
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US12/868,558 Expired - Fee Related US8366737B2 (en) | 2001-01-23 | 2010-08-25 | Expandable emboli filter and thrombectomy device |
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US09/768,653 Expired - Lifetime US6610077B1 (en) | 2001-01-23 | 2001-01-23 | Expandable emboli filter and thrombectomy device |
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US12/868,558 Expired - Fee Related US8366737B2 (en) | 2001-01-23 | 2010-08-25 | Expandable emboli filter and thrombectomy device |
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Also Published As
Publication number | Publication date |
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US8366737B2 (en) | 2013-02-05 |
US6610077B1 (en) | 2003-08-26 |
US20110106138A1 (en) | 2011-05-05 |
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