Patent Application
20100204772
The present invention, in some embodiments thereof, relates to vascular filters that filter debris from the blood. More particularly, but not exclusively, the present invention relates to vascular filters that expand in conjunction with radially expandable vascular flow-increasing devices, for example balloon catheters and/or stents.
In 1977 Andreas Gruntzig performed the first successful balloon angioplasty on an obstructed human artery, thereby opening the vessel and allowing improved flow of blood. While providing a tremendous advance in cardiology, angioplasty could not prevent restenosis, wherein tissue at the angioplasty site again became blocked.
The use of stents to prevent restenosis in treated stenotic vasculature began in 1994 following U.S. Food and Drug Administration approval of the Palmaz-Schatz stent.
A problem associated with balloon angioplasty and stent deployment is that during radial expansion of the radially expandable vascular flow-increasing device against the stenotic lesion, the stenotic lesion may release debris that travels to vital organs, for example the brain and/or lungs, causing vascular blockage, tissue necrosis and/or patient death.
To prevent such draconian sequela, a number of in vivo debris filter assemblies have been developed that are designed to be deployed distal to a radially expandable vascular flow-increasing device and capture debris released from stenotic lesions. A distal filter typically comprises a porous flexible material supported by a stiff frame.
Prior to introducing the stent and/or balloon, a distal filter is expanded at a site distal to the stenotic lesion. The balloon and/or stent is then guided into place proximate to the stenotic lesion and expanded. As blood passes through the filter, debris generated by the radial outward expansion of the balloon and/or stent is captured in the filter.
The filter is collapsed at the end of the procedure, trapping the debris.
In balloon angioplasty, the filter is pulled out of the vasculature trailing the balloon. In stent deployment, the filter is pulled through the stent during retrieval. Examples of expandable vascular filters can be found in: U.S. Pat. No. 6,391,044 (Yadav et al); U.S. Pat. No. 5,814,064 (Daniel et al); U.S. Pat. No. 4,723,549 (Wholey et al); and U.S. Pat. No. 5,827,324 (Cassell et al), the contents of all of which are incorporated herein in their entirety by reference.
Some embodiments of the present invention successfully address at least some of the shortcomings of the prior art by providing a filter that is operatively connected to a radially expandable vascular flow-increasing device.
In embodiments, for example, the filter opening is attached to, and expands along with, the a radially expandable vascular flow-increasing device such that when the opening is in an expanded configuration, the filter is configured to filter debris from a fluid stream in which the filter is disposed.
In embodiments, the radially expandable vascular flow-increasing device comprises an angioplasty balloon. In other embodiments, the radially expandable assembly comprises an angioplasty balloon in combination with a stent. While in still further embodiments, the radially expandable assembly comprises a self expanding stent.
In embodiments, the operative connection comprises an adhesive. In embodiments, the radially expandable vascular flow-increasing device includes at least one cord operatively associated with the filter and configured to disconnect at least a portion of the filter from the radially expandable assembly when tension is applied to the at least one cord.
In embodiments, when used in conjunction with a balloon, at least a portion of the filter is configured to remain removably connected to a luminal aspect of the vessel during the contraction of the balloon.
According to one embodiment of the invention, there is provided a filter assembly, comprising: a radially expandable vascular flow-increasing device, and a filter including an expandable proximal opening having an operative connection with the radially expandable vascular flow-increasing device, the proximal opening configured to expand in conjunction with expansion of the device, such that when the opening is in an expanded configuration, the filter is configured to filter debris from a fluid stream in which the filter is disposed.
In some embodiments, the radially expandable vascular flow-increasing device comprises: at least one balloon configured to volumetrically expand and, during at least a portion of the expansion, operatively connect with a filter, and to contract following the expansion, and the operative connection comprises an operative connection between the filter and the at least one balloon during at least a portion of the volumetric expansion of the at least one balloon.
In some embodiments, the at least one balloon comprises at least one proximal portion and at least one distal portion.
In some embodiments, the filter operatively connects with the balloon at least one of the at least one proximal portion, and the at least one distal portion.
In some embodiments, a maximal expansion diameter of the at least one distal portion of the at least one balloon is greater than a maximal expansion diameter of the at least one proximal portion of the at least one balloon
In some embodiments, a maximal expansion diameter of the at least one proximal portion of the at least one balloon is greater than a maximal expansion diameter of the at least one distal portion of the at least one balloon.
In some embodiments, the at least one balloon comprises at least one angioplasty balloon.
In some embodiments, at least a portion of the filter is configured to remain removably connected to a luminal aspect during the contraction of the at least one balloon.
In some embodiments, the assembly includes at least one cord operatively associated with the filter and configured to disconnect at least a portion of the filter from the luminal aspect when tension is applied to the at least one cord.
In some embodiments, at least a portion of the filter includes a pressure-sensitive adhesive having an affinity for a tissue associated with an in vivo luminal aspect.
In some embodiments, the adhesive is an adhesive from the group of adhesives comprising fibrin, biological glue, collagen, hydrogel, hydrocolloid, collagen alginate, and methylcellulose.
In some embodiments, at least a portion of the filter is configured to remain removably connected to the luminal aspect during the contraction of the at least one balloon.
In some embodiments, the assembly includes at least one cord operatively associated with the filter and configured to disconnect the at least a portion of the filter from the luminal aspect when tension is applied to the at least one cord.
In some embodiments, the assembly includes a compression sleeve comprising a substantially curved wall having a proximal end, a distal end and a lumen extending from the proximal end to the distal end, the lumen having a cross sectional diameter that is substantially smaller than the maximal cross sectional diameter of the luminal aspect.
In some embodiments, the assembly includes at least one cord operatively associated with the filter, at least a portion of the at least one cord movingly juxtaposed within the compression sleeve lumen.
The assembly according to claim 16 wherein when the at least one cord operatively associated with the filter is held relatively stationary during a first distal moving of the compression sleeve, the filter is caused to disconnect from the luminal aspect.
In some embodiments, in response to at least one second distal moving of the sleeve while the at least one cord is held relatively stationary, the filter is caused to radially contract such that a maximal cross sectional diameter of the filter is smaller that a cross sectional diameter of the sleeve lumen.
In some embodiments, in response to at least one third distal moving of the sleeve while the at least one cord is held stationary, at least a portion of the filter is caused to enter the sleeve lumen.
The assembly according to claim 10, wherein: the at least one balloon comprises an outer wall having a distal end and a proximal end and an inner wall defining a lumen, the lumen extending from the distal end to the proximal end, and at least a portion of the at least one cord is configured to slidingly pass through the lumen.
In some embodiments, the at least one cord is configured to pull at least a portion of the filter into contact with the distal end of the at least one balloon.
In some embodiments, the filter includes a distal portion, a proximal portion, an opening to the filter associated with the proximal portion and at least one strut operatively associated with the proximal portion.
In some embodiments, the assembly includes at least one cord operatively associated with the at least one strut, such that at least a portion of the opening is configured to contract radially inwardly in response to tension applied to the at least one cord.
In some embodiments, the at least one strut comprises at least two struts, at least one first strut and at least one second strut, the at least two struts being operatively associated with the at least one cord.
In some embodiments, the at least two struts are configured to resiliently flex outward with respect to a longitudinal axis passing through a center of the filter during at least a portion of the volumetric expansion of the at least one balloon.
In some embodiments, during at least a portion of the outward flexion of the at least two struts: the at least one first strut forms at least one first radius, and the at least one second strut forms at least one second radius with respect to the longitudinal axis.
In some embodiments, the filter includes: a distal portion, a proximal portion, an opening to the filter associated with the proximal portion, and at least one cord guide channel circumferentially encircling at least a portion the proximal portion.
In some embodiments, the assembly includes at least one cord, at least a portion of the at least one cord passes through the guide channel, such that at least a portion of the opening is configured to contract radially inwardly in response to tension applied to the at least one cord.
In some embodiments, the radially expandable vascular flow-increasing device comprises: at least one balloon configured to volumetrically expand and, during at least a portion of the expansion, operatively connect with a filter, and, following the connection, to contract following the expansion, the filter comprises a material having tissue connective properties for a portion of luminal tissue associated with an in vivo fluid stream, and the operative connection comprises an operative connection between the filter and the at least one balloon during at least a portion of the volumetric expansion of the at least one balloon.
In some embodiments, the radially expandable vascular flow-increasing device comprises: a radially expandable stent configured to open a stenotic lumen, the radially expandable stent having a proximal end, a distal end and a lumen connecting the proximal and the distal ends, an expandable balloon mounted on a distal portion of an elongate catheter, the expandable balloon configured to expand within the lumen of the expandable stent and cause the expandable stent to expand, and the operative connection comprises an operative connection between the filter and the expandable stent.
In some embodiments, the filter comprises a billowing filter.
In some embodiments, the expandable opening of the filter is removably connected to the stent.
In some embodiments, the assembly includes at least one cord operatively associated with the filter and configured to disconnect at least a portion of the filter from the expandable stent when tension is applied to the at least one cord.
In some embodiments, the expandable opening of the filter is operatively connected with the stent such that expansion of the stent causes expansion of the expandable opening of the filter.
In some embodiments, the radially expandable vascular flow-increasing device comprises: a radially expandable stent configured to open a stenotic lumen, the radially expandable stent having a proximal end, a distal end and a lumen connecting the proximal and the distal ends, and the operative connection comprises an operative connection between the filter and the expandable stent.
In some embodiments, the expanding stent is self-expanding.
In some embodiments, the assembly includes a stent holding spindle operatively associated with the stent when the stent is in a contacted configuration, the spindle being mounted on a distal portion of an elongate catheter.
In some embodiments, the stent holding spindle includes a channel.
In some embodiments, the assembly includes at least one cord operatively associated with the filter, at least a portion of the at least one cord being configured to slidingly pass through the channel through the spindle.
In some embodiments, the at least one cord is configured to pull at least a portion of the filter opening into contact with at least a portion of the spindle.
In some embodiments, the radially expandable vascular flow-increasing device comprises: a radially expandable stent configured to open a stenotic lumen, the radially expandable stent having a proximal end, a distal end and a lumen connecting the proximal and the distal ends, a jacket substantially surrounding an exterior surface of the expandable stent, the jacket configured in to expand in conjunction with expansion of the expanding stent, and the operative connection comprises an operative connection between the filter and the jacket.
In some embodiments, the stent comprises a self-expanding stent and the assembly includes a compression sleeve comprising a substantially curved wall having a proximal end, a distal end and a lumen extending from the proximal end to the distal end, the compression sleeve configured to slidingly encircle the stent when the stent is in a contracted configuration.
In some embodiments, the assembly includes at least one cord, a portion of the at least one cord being movingly juxtaposed within the compression sleeve lumen.
In some embodiments, the filter includes at least one cord guide channel circumferentially encircling at least a portion the proximal opening of the filter.
In some embodiments, the assembly includes at least one cord, at least a portion of the at least one cord passes through the guide channel, such that at least a portion of the opening is configured to contract radially inwardly in response to tension applied to the at least one cord.
In some embodiments, the assembly includes a belt that provides the operative connection between the jacket and the filter.
In some embodiments, the belt is looped in at least one loop that removable connects the expandable opening of the filter with the jacket.
In some embodiments, a tension applied to the belt causes the loop to disconnect from the expandable opening of the filter with the jacket, thereby removing the operative connection between the opening to the filter and the jacket.
In some embodiments, the belt includes at least one connector that removably connects the filter to the jacket, the at least one connector from the group comprising a hook and a zipper.
According to still another aspect of the invention, there is provided a method for collecting debris while applying a expandable vascular flow-increasing device to a primary stenotic vessel and preventing passage of the debris into a branch vessel branching from the primary vessel, the method comprising: detecting a stenotic lesion in the primary stenotic vessel, locating a filter in the primary stenotic vessel such that an opening of the filter is distal to a center of the stenotic lesion, locating at least a proximal portion of an expandable vascular flow-increasing device proximal to the opening in the filter, expanding the expandable vascular flow-increasing device, contacting the opening of the filter with at least a distal portion of the expandable vascular flow-increasing device during the expanding, causing the filter to open during the contacting, generating debris from the stenotic lesion by the expanding of the expandable vascular flow-increasing device, capturing the debris in the filter, contracting the filter, and removing the filter from the primary stenotic vessel.
According to still another aspect of the invention, there is provided a method for collecting debris while applying a expandable vascular flow-increasing device to a stenotic vessel, the method comprising: juxtaposing an opening of an in vivo debris filter with a radially expandable vascular flow-increasing device, expanding the expandable vascular flow-increasing device in a blood vessel, opening the filter during the expansion of the expandable vascular flow-increasing device, collecting debris within the filter, disengaging the filter from the expandable vascular flow-increasing device, contracting the filter, and removing the filter from the vessel.
According to still a further aspect of the invention, there is provided an assembly comprising a stent for opening a stenotic lumen and a filter for filtering debris during the opening, the assembly comprising a radially expandable stent configured to open a stenotic lumen, the radially expandable stent having a proximal end, a distal end and a lumen connecting the proximal and the distal ends, and a jacket comprising a curved wall having an interior surface, a proximal end, a distal end and a lumen connecting the proximal end to the distal end, the interior surface substantially surrounding an exterior surface of the expandable stent such that at least a portion of the interior surface is moveably juxtaposed against the stent exterior surface.
Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.
Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.
In the drawings:
a-3e show stent and debris filter assemblies being deployed in vessels shown in cross section, according to embodiments of the invention;
a-4f show jacketed stents according to embodiments of the invention;
a-6h show jacketed stent and debris filter assemblies being deployed in vessels shown in cross section, according to embodiments of the invention;
a-7d show deployment of an in vivo filter and balloon assembly in a vessel shown in cross section, according to an embodiment of the invention; and
a-8d, 9a-9c, 10, and 11a-11e show alternative embodiments of the filter and balloon assembly shown in
The present invention, in some embodiments thereof, relates to vascular filters that filter debris from the blood and, more particularly, but not exclusively, to vascular filters that expand in conjunction with a radially expandable vascular flow-increasing device to filter debris from the blood.
Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details set forth in the following description or exemplified by the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.
Some embodiments of the present invention relate to vascular filters that expand in conjunction with radially expandable vascular flow-increasing devices. The phrase “radially expandable vascular flow-increasing devices” refers to, inter alia, balloon catheters, balloon catheters in conjunction with stents, jacketed stents and self expanding stents.
a shows a representation of an in vivo stent filter assembly 100 in a cross section of a blood vessel 141; assembly 100 comprising a stent 241 and a filter 122.
In embodiments, stent 241 is positioned adjacent a stenotic lesion 144 with a catheter balloon 130 inside stent 241. As seen in
Filter opening 124 is configured to flex radially outward until limited by a luminal aspect 140, having, for example, a diameter of between 3.0 and 6.0 millimeters, depending on the size of lumen 142 in which filter 122 is deployed. Filter 122 typically comprises a mesh sheet material that is configured to filter debris 160 from lumen 142.
As stenotic lesion 144 is cracked and squashed radially outwards by the expansion of stent 241, fluid passes through vessel lumen 142 in a distal or downstream direction 162 and carries debris 160 into filter 122. As used herein, the terms distal and distally refer to a position and a movement, respectively, in downstream direction 162.
As seen in
As seen in
In an embodiment, filter 122 is configured to disconnect from luminal aspect 140 in response to tension applied to cords 112 of at least about one Newton and no more than about 20 Newtons.
As the diameter of lumen 142 is larger than the diameter of catheter channel 148, continued upstream pull on cords 112 proximally 164 biases filter opening 124 radially inward in direction 215. Fluid in lumen 142 travels distally in direction 162 so that pulling catheter 132 and filter 122 proximally 164 causes debris 160 to move downstream against filter 122. Debris 160 remains captured by filter 122 even as filter 122 moves with filter opening 124 in a fully or partially open position, as might occur when there is considerable volume of debris 160, for example in large arteries.
As seen in
Stent 241 typically includes a metallic base, for example stainless steel, nitinol, tantalum, MP35N alloy, a cobalt-based alloy, platinum, titanium, or other biocompatible metal alloys. During expansion of stent 241, filter opening 124 is substantially supported by stent 241, reducing the need for support by an integral stiff frame as is known in the art.
Such a filter 122, herein billowing filter 122, has substantially reduced bulk over filters in the art that have support frames. Billowing filter 122 will readily contract to an amorphous small mass that easily passes through stent 241 without spilling debris.
Billowing filter 122 extends directly from stent 241 and contacts unhealthy tissue of luminal aspect 140. Due to proximity to stent 241, billowing filter 122 is substantially unlikely to cause damage to healthy tissue of luminal aspect 140.
The absence of the above-noted support structure allows billowing filter opening 124 to gently contact luminal aspect 140. Billowing filter opening 124, therefore substantially prevents damage in special situations where stent 241 is deployed in luminal aspect 140 comprising healthy tissue.
Additionally, the proximity of filter 122 to stent 241 ensures that a branch artery (not shown) cannot interpose between filter 122 and stent 241 to act as a conduit for debris 160 as would be the case if filter 122 was further away from stent 241. Other possible advantages of stent filter assembly 100 over existing technology accrue from stent 241, balloon 130 and filter 122 being deployed on single catheter 132, and include:
a) lower manufacturing-related costs for a single assembly 100 including stent 241 and filer 122 as compared to existing technology comprising separate filter and stent assemblies; and
b) lower surgical fees for performing a single procedure with single catheter 132 as compared to procedures associated with existing technology, noted above.
In embodiments, balloon 130 optionally comprises alternative shapes, for example having varied cross sectional diameters. As seen in an assembly 150 (
In an embodiment, filter 122 is separate from stent 241 and is pushed in direction 162 using cords 112 and/or distal balloon portion 133.
As seen in
As seen in
In
By remaining in contact with luminal aspect 140, filter 122 continues to filter debris 160 that may be released into lumen 142 from lesion 144 following radial expansion of stent 241. Filter 122 is contemplated to remain attached to luminal aspect 140 until danger of generation of debris 160 passes, for example between an hour and 24 hours. When filter 122 remains in position for an extended period, balloon 130 is optionally deflated and removed from lumen 142 while filter 122 and cords 112 are left in place.
In some embodiments, the type of the material and/or configuration of apertures in filter 122 ensure that filter 122 remains removably connected to luminal aspect 140 following deflation of balloon 130. In other embodiments, filter 122 includes a pressure sensitive adhesive having an affinity for luminal aspect 140 so filter 122 remains removably connected to vessel luminal aspect 140 following deflation of balloon 130.
There are many adhesives that may be contemplated for use in providing a removable connection of filter 122 to luminal aspect 140 including, inter alia: fibrin, biological glue, collagen, hydrogel, hydrocolloid, collagen alginate, and methylcellulose, to name a few.
Whether filter 122 comprises a mesh material alone or in combination with an adhesive, filter 122 is optionally configured to connect to luminal aspect 140 from pressure exerted by balloon 130 of, for example, between one and twenty atmospheres.
As seen in
Assembly 400 (
Self-expanding stent 248 includes adherent areas 272 that adhere distal portion of stent 248 to filter opening 124.
As seen in
As seen in
While adherent areas 272 are shown as being attached to stent 248 and removably connected to filter 122, it is easily understood to those familiar with the art that adherent areas 272 optionally are attached to filter 122 and removably connected to stent 248.
While adherent areas 272 are shown as being internal to stent 248 and external to filter 122, it is easily understood to those familiar with the art that adherent areas 272 optionally are external to stent 248 and internal to filter 122.
As seen in
In embodiments, stent 248 comprises an alloy that includes tantalum, tungsten, and zirconium: tantalum from about 20% to about 40% by weight; tungsten from about 0.5% to about 9% by weight; and zirconium from about 0.5% to about 10% by weight.
In alternative embodiments, self-expanding stent 248 comprises an alloy such as nitinol (Nickel-Titanium alloy), having shape memory characteristics.
Shape memory alloys have super-elastic characteristics that allow stent 248 to be deformed and restrained on spindle 232 during insertion through vessel 141. When compression sleeve 134 is removed (
As used herein, a nitinol alloy refers to an alloy comprising between about at least 50.5 atomic percent Nickel to no more than about 60 atomic percent Nickel with the remainder of the alloy being Titanium. The term nitinol is intended to refer to a two-component memory metal stent discussed above as well as any other type of known memory metal stent.
a shows a jacketed stent 200 comprising an outer jacket 270 and an inner stent 242 that are connected by a distal connection 290. As seen in
During radially outward expansion in a direction 256, stent 242 typically contracts considerably in directions 258 while jacket 270 remains relatively stationary with respect to stent 242. Jacket 270 allows contraction of stent 242 while buffering shear forces generated by stent 242 on lesion 144 (
In embodiments, distal connection 290 optionally comprises a process of sewing, adhesion, gluing, suturing, riveting and/or welding. Optionally, distal connection 290 is offset proximally 164 along stent 242, for example up to and including the center of stent 242 or along distal portion of stent 242.
c and 4d show a jacketed stent 300 in which distal portion 162 of jacket 270 is folded over distal portion 162 of stent 242. Stent 242 is therefore substantially completely unattached to jacket 270. During radially outward expansion in direction 256, contraction of stent 242 in directions 258 results in gaps 282 between stent 242 and stent jacket 270 so that luminal vessel aspect 140 (
e and 4f show still another embodiment in which a jacketed stent 390 comprises jacket 270 that is folded over both the proximal 164 and distal 162 aspects of stent 242. Upon expansion of stent 242, distal gap 282 and/or a proximal gap 284 optionally form due to jacket 270 remaining substantially stationary with respect to contraction in directions 258 of stent 242.
In embodiments, jacket 270 is formed by a process including knitting, braiding, knotting, wrapping, interlacing, electrospinning and/or dipping a porous mold into one or more reagents.
In embodiments, jacket 270 is formed from one or more fibers having a diameter of between at least about 3 microns and no more that about 100 microns.
In embodiments, jacket 270 contains apertures 240 that substantially prevent generated stenotic debris and/or plaque associated with stenotic lesion 144 (
In embodiments, jacket 270 has a thickness of between at least about 20 microns and no more that about 200 microns.
In embodiments, unexpanded stent 242 has a diameter of at least about 0.3 millimeters and no more than about 3.0 millimeters; while expanded stent 242 has a diameter of at least about 1.0 millimeter to not more than about 8.0 millimeters.
In embodiments, jacket 270 and/or stent 242 comprise materials that are coated and/or imbued with one or more active pharmaceutical agents for the purpose of preventing infection, inflammation, coagulation and/or thrombus formation.
Jacketed stents 200, 300 and 390 are optionally designed for use in a wide variety of vascular tissue including coronary, peripheral, cerebral, and/or carotid vascular tissue. Additionally, jacketed stents 200, 300 and 390 are optionally designed for use in treating an aortic aneurysm and/or a body lumen, for example a lumen associated with pulmonary tissue.
The many materials, manufacturing methods, uses and designs of jacket 270 and stent 242 are well known to those familiar with the art.
a shows a jacketed stent and filter assembly 500 comprising a removable belt 250 that is looped through filter 122 and jacket 270 and passes through compression sleeve 134 for manipulation by an ex vivo operator. In
In
While belt 250 is shown as being removably connected by running loops that pass through holes in jacket 270 and filter 122, there are many alternative removable connections contemplated. For example belt 250 optionally includes a series of hooks (not shown) that pass through apertures in jacket 270 and filter 122. Alternatively, belt 250 is optionally attached to a zipper-like mechanism that connects filter 122 to jacket 270; the many options for providing a removable connection between filter 122 and jacket 270 being easily understood by those familiar with the art.
In embodiments, cord 112 serves to cinch filter 122 closed. As shown, cord 112 passes distally 162 through channel 148 into a cinch channel 120, also referred to as guide channel 120 and cord channel 120, through a cord guide inlet 184. Cinch channel 120 guides cord 112 circumferentially around filter 122 until cord 112 exits cinch channel 120 through a cord outlet 186. Cord 112 then passes distally 162 through catheter channel 148 that passes through spindle 232 and catheter 132.
In this manner both ends of cord 112 exit catheter channel 148 and, by pulling both ex vivo ends of cord 112 proximally 164, filter 122 is contracted along cinch channel 120. As seen in
As seen in
While a single cord 112 and cinch channel 120 are shown, cinch channel 120 optionally comprises multiple pairs of inlets 184 and outlets 186, each associated with a separate cord 112. The many configurations and modifications of cinch channel 120, inlet 184, and outlet 186 are well known to those familiar with the art.
a-6g show jacketed stent 600 in which cords 112 are connected to proximal portion 164 of filter 122 and pass internal to jacketed stent 600 and compression sleeve 134, along spindle 232. Removable belt 250 similarly passes internal to jacketed stent 600 and compression sleeve 134, and connects with filter 122 and jacket 270 just below connection 290.
Following radial expansion of jacketed stent 600 (
In
Filter 122 is shown partially pulled into compression sleeve 134 and compression sleeve 134 and filter 122 are now pulled in tandem, proximally 164 for percutaneous removal from lumen 142.
In embodiments, filter 122 is pulled completely into compression sleeve 134 so that compression sleeve 134 serves as a housing for filter 122 to prevent filter 122 from rubbing against luminal aspect 140 during removal from lumen 142.
a shows an exemplary representation of an in vivo debris filter assembly 1100 of the present invention, in a cross section of a blood vessel 141. Filter 122 is shown in a contracted, pre-dilated, position with loose cords 110 attached to two struts 128 that are connected to filter 122. Cords 110 exit filter 122 and pass through a lumen 138 and into and through catheter 132. Cords 110 typically exit lumen 138 ex vivo, thereby allowing ex vivo manipulation by an operator.
A balloon 130 projects downstream of catheter 132 and is positioned adjacent to stenotic lesion 144. Balloon 130 typically comprises a biologically compatible elastomeric material, or semi compliant material, for example: rubber, silicon rubber, latex rubber, polyethylene, polyethylene terephthalate, Mylar, and/or polyvinyl chloride.
In
Once inflated, filter 122 filters debris 160 that is released from stenotic lesion 144 and continues to filter debris 160 even as balloon 130 is deflated, as explained below.
While filter 122 is shown in an expanded position as a generally curved structure, balloon 130 may alternatively have a variety of shapes, including a conus having an apex located downstream of balloon 130.
Filter 122 typically comprises a mesh sheet material that is configured to filter debris 160 from lumen 142. Filter 122 typically includes apertures having diameters of between at least about 20 microns and no more than about 200 microns in diameter.
Additionally, filter 122 and/or struts 128, are configured to flex outward until such flexion is limited by a luminal aspect 140, for example a diameter of between 3.0 and 6.0 millimeters, depending on the size of lumen 142 in which filter 122 is deployed.
In further embodiments, portions of filter 122 and/or struts 128 comprise superelastic material, for example nitinol; an elastic material; and/or a plastic material; the many materials and their properties being well-known to those familiar with the art.
Similarly, balloon 130 has an inflation diameter of between 3.0 and 6.0 millimeters, depending on the cross sectional diameter of lumen 142. In larger vessels 141, balloon 130 and filter 122 optionally are manufactured to have larger maximal diameters. In smaller vessels, for example to cut down on the bulk of deflated balloon 130 and filter 122, smaller maximal diameters are optionally appropriate.
Filter 122 comprises materials and/or apertures that aid in removably connecting filter 122 to an in vivo luminal aspect 140. In this manner, filter 122 remains connected to luminal aspect 140 for a period of time after balloon 130 has deflated, herein contracted, by egress of fluid through channel 148. By remaining in contact with luminal aspect 140, filter 122 continues to filter debris 160 that may be released into lumen 142 from lesion 144 while balloon 130 is in a contracted state.
In some embodiments, the material and configuration of filter 122 ensures that filter 122 remains removably connected to luminal aspect 140 following deflation of balloon 130. In other embodiments, filter 122 includes a pressure sensitive adhesive having an affinity for luminal aspect 140 so that the adhesive, optionally in conjunction with the material of filter 130, remain removably connected to vessel luminal aspect 140 following deflation of balloon 130.
There are many adhesives that may be contemplated for use in providing a removable connection of filter 122 to luminal aspect 140 including, inter alia: fibrin, biological glue, collagen, hydrogel, hydrocolloid, collagen alginate, and methylcellulose, to name a few.
Whether filter 122 comprises a mesh material alone or in combination with an adhesive, filter 122 is optionally configured to removably connect to luminal aspect 140 from pressure exerted by balloon 130 of, for example, between one and twenty atmospheres.
In further exemplary embodiments, for example when there is continued danger of debris 160 being generated after lesion 144 has been compressed, balloon 130 is optionally deflated and removed from lumen 142, while filter 122 is left in place. Filter 122 optionally is left connected to luminal aspect 140 by the configuration of filter 122 and/or biological glues noted above until the danger of generation of debris 160 has passed.
As noted above, during a typical balloon angioplasty, balloon 130 is sequentially inflated to a pressure of several atmospheres and deflated. In exemplary embodiments, filter 122 remains removably connected to luminal aspect 140 following the first inflation of balloon 130 and throughout several sequences of inflation and deflation.
As filter 122 is deployed relatively proximate to lesion 144 where luminal aspect 140 generally comprises unhealthy tissue, the chance that filter 122 will cause damage to healthy tissue of luminal aspect 140 is very low.
Additionally, the proximity of filter 122 to balloon 130 substantially lowers the odds that a branch artery will be located between filter 122 and balloon 130, to act as a conduit for debris 160. Further, as balloon 130 and filter 122 are deployed on single catheter 132, the cost for each assembly 1100 should be lower than existing technology employing a separate filter. Moreover, as assembly 1100 includes balloon 130 and filter 122 mounted on a single catheter, the complexity of manufacture, deployment and the surgical fees to the surgeon should be reduced over existing technology.
As seen in
To disconnect filter 122 from luminal aspect 140, cords 110 are pulled proximally, upstream, in direction 164. Cords 110 are then pulled further to cause filter 122 to enclose debris 160 as seen in
While cords 110, as shown, pass through catheter lumen 138, in alternative embodiments, cords 110 pass to the side of balloon 130 without passing through lumen 138. Further, while balloon 130 is shown attached to catheter 132, there are many alternative options for delivering balloon 130 and filter 122, for example using a guide wire. Those familiar with the art will readily recognize the many alternative modes and configurations available for delivery and operation of balloon 130 and filter 122.
In an exemplary embodiment, filter 122 is configured to disconnect from luminal aspect 140 in response to tension applied to cords 110 of at least about one Newton and no more than about 20 Newtons.
As the diameter of lumen 142 is larger than the diameter of catheter lumen 138, continued upstream pull in direction 164 on cords 110, biases the proximal portions of struts 128 radially inward, causing the proximal edges of filter 122 to move radially inward so that filter 122 disconnects from luminal aspect 140. Following disconnection of filter 122 from luminal aspect 140, continued pulling of cords 110 in direction 164 causes struts 128 to inwardly bias, thereby reducing the upstream cross sectional diameter of filter 122.
As the fluid in lumen 142 travels distally in direction 162, pulling catheter 132 and filter 122 in proximal direction 164 causing debris 160 to move downstream against filter 122 so that debris 160 remains captured by filter 122.
Thus, filter 122 maintains captured debris 160 even when there is a distance between struts 128, as might occur when there is considerable volume of debris 160, for example in large arteries. Optionally, cords 110 are pulled in direction 164 until a portion of filter 122 contacts balloon 130 and/or enters catheter lumen 138.
While two struts 128 are shown connected to two cords 110, the present embodiments, contemplate four or even eight struts 128, with each strut 128, or each pair of struts 128, being attached to individual cords 110 that remove filter 122 from luminal aspect 140.
Alternatively, assembly 1100 contemplates using a single strut 128 with a single cord 110 connected to it that encircles filter 122 and slidingly attaches to strut 128 in a lasso configuration. Pulling on single cord 110 causes contraction of struts 128 and of the associated cross-sectional circumference of filter 122, thereby preventing egress of debris 160 filter 122. The many options available for configuring cords 110 and struts 128 to effectively close filter 122 are well known to those familiar with the art.
a shows an exemplary embodiment of an assembly 1200 in which single cord 112 passes distally in direction 162 through catheter lumen 138. Cord 112 then curves within filter 122 to pass in a proximal direction 164 into a cord inlet 184 and through cord channel 120. Cord channel 120 guides cord 112 circumferentially around filter 122. After circling filter 122, cord 112 exits channel 120 through cord outlet 186 and passes distally in direction 162 into filter 122. Cord 112 then curves within filter 122 to pass in a proximal direction 164 into and through catheter lumen 138.
In this manner both ends of cord 112 exit catheter lumen 138 and, by pulling both ex vivo ends of cord 112 in direction 164, filter 122 is contracted along cord channel 120, as seen in
While a single cord 112 is shown, channel 120 optionally comprises multiple pairs of inlets 184 and outlets 186, each associated with a separate cord 112. The many configurations and modifications of channel 120, inlet 184, and outlet 186 are well known to those familiar with the art.
d shows an exemplary embodiment of a tubular compression sleeve 134 that is coaxial with catheter 132. Sleeve 134 has been slidingly pushed through vessel lumen 142 in direction 162 until sleeve 134 approaches filter 122.
In an exemplary embodiment, pulling cord 112 and/or catheter 132 in direction 164 while holding sleeve 134 substantially stationary, pulls filter 122 into compression sleeve 134. Alternatively, compression sleeve 134 is advanced in direction 162 while catheter 132 and/or cord 112 are held substantially stationary.
In an exemplary embodiment, compression sleeve 134 serves as a housing for filter 122 to prevent filter 122 from scraping along luminal aspect 140 during removal from lumen 142. Additionally or alternatively, compression sleeve 134 serves to compress filter 122 into a smaller maximal circumferential diameter so that filter 122 more easily passes through lumen 142 during removal of filter 122.
In embodiments, balloon 130 optionally includes alternative shapes, for example having varied cross sectional diameters. As seen in assembly 1300 (
As seen in
As seen in
There are additionally many methods of assembling filter 122 and balloon 130, as seen in assembly 1400 (
Additionally, balloon 130 is shown with a proximal portion 207 having a length 235 of approximately 18 millimeters and a distal portion 208 having a length 233 of approximately 18 millimeters.
In an exemplary embodiment, filter 122 extends to substantially cover distal portion 208 while proximal portion 207 is unprotected by filter 122.
In alternative configurations of assembly 1400, filter 122 optionally substantially fully covers distal balloon portion 208 and extends over at least a portion of proximal balloon portion 207; the many configurations of assembly 1400 being well known to those familiar with the art.
Assembly 1500 (
After deflation of proximal balloon 230 as seen in
As seen in
While assemblies 1100-1500 have been described with respect to vessel 141, assemblies 1100-1500 can be easily configured for use in a wide variety of in vivo lumens 142 including inter alia: a lumen of a urethra, a biliary lumen and/or a renal calyx lumen. Additionally or alternatively, filter 122 can be easily modified to capture debris in virtually any in vivo lumen 142 including, inter alia: biliary stones and/or renal stones. The many applications, modifications and configurations of assemblies 1100-1500 for use in virtually any in vivo lumen 142 will be readily apparent to those familiar with the art.
In embodiments, the sheet material of filter 122 is selected from the group consisting of meshes and nets.
In embodiments, bending of a portion of the sheet material of filter 122 forms cinch channel 120. In embodiments, attaching a shaped component to filter 122 forms cinch channel 120 (
In embodiments, filter 122 is configured to expand to a cross sectional diameter of at least about 1.0 millimeters. In embodiments, filter 122 is configured to expand to a cross sectional diameter of no more than about 6.0 millimeters. In embodiments, the extent of the expansion of filter 122 is configured to be limited by the walls of luminal aspect 140 in which filter 122 is deployed.
In embodiments, balloon 130 (
In embodiments, balloon 130 has a wall thickness of at least about 0.2 millimeters. In embodiments, balloon 130 has a wall thickness of no more than about 0.5 millimeters.
In embodiments, filter 122 (
In embodiments, catheter 132 (
In embodiments, the walls of catheter 132 and compression sleeve 134 (
In embodiments, jacket 270, (
In embodiments, jacket 270, filter 122, cord 112, compression sleeve 134, spindle 232 and catheter 132, comprise a material selected from the group consisting of: nitinol, stainless steel shape memory materials, metals, synthetic biostable polymer, a natural polymer, and an inorganic material. In embodiments, the biostable polymer comprises a material from the group consisting of: a polyolefin, a polyurethane, a fluorinated polyolefin, a chlorinated polyolefin, a polyamide, an acrylate polymer, an acrylamide polymer, a vinyl polymer, a polyacetal, a polycarbonate, a polyether, a polyester, an aromatic polyester, a polysulfone, and a silicone rubber.
In embodiments the natural polymer comprises a material from the group consisting of: a polyolefin, a polyurethane, a Mylar, a silicone, and a fluorinated polyolefin.
In embodiments, jacket 270, filter 122, cord 112, compression sleeve 134, spindle 232 and catheter 132, comprise materials having a property selected from the group consisting of: compliant, flexible, plastic, and rigid.
In embodiments, balloon 130 comprises a biologically compatible elastomeric material, or semi-compliant material, for example: rubber, silicon rubber, latex rubber, polyethylene, polyethylene terephthalate, Mylar, and/or polyvinyl chloride.
Balloon 130 typically has an inflation diameter of between 3.0 and 6.0 millimeters, depending on the cross sectional diameter of lumen 142. In larger vessels 141, balloon 130 and filter 122 optionally are manufactured to have larger maximal diameters. In smaller vessels, for example to reduce the bulk of contracted stent 241 and filter 122, smaller maximal diameters, hence less reduced material in stent 241 and filter 122, may be contemplated.
While balloon 130 is shown attached to catheter, 132, there are many alternative options for delivering balloon 130 and filter 122, for example using a guidewire. Those familiar with the art will readily recognize the many alternative modes and configurations available for delivery and operation of balloon 130 and filter 122.
It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.
Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art.
Accordingly, the invention is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.
| Number | Date | Country | Kind |
|---|---|---|---|
| 11582354 | Oct 2006 | US | national |
This application claims benefit of priority from U.S. patent application Ser. No. 11/582,354 and U.S. Provisional Application No. 60/852,392, both filed 18 Oct. 2006. The contents of all of the above documents are incorporated by reference as if fully set forth herein.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/IL07/01254 | 10/18/2007 | WO | 00 | 4/17/2009 |
| Number | Date | Country | |
|---|---|---|---|
| 60852392 | Oct 2006 | US |
