Patent Grant
9301829
The present invention generally relates to intravascular devices used in interventional procedures. More specifically, the present invention relates to systems and methods for extracting debris, e.g., emboli, thrombi, etc., during the placement and retrieval of a blood permeable filtration device.
Vascular procedures such as angioplasty, atherectomy, thrombectomy, stent placement, etc., used for treating occlusive vascular diseases cause material to dislodge from the inside wall of blood vessels and enter the bloodstream. The dislodged material (e.g., plaque), known as emboli, may be sufficiently large to occlude downstream blood vessels, potentially blocking blood flow to tissue. Additionally, blood clots, known as thrombi, may form and either be sufficiently large or grow over time and block a blood vessel should the thrombus become released into the bloodstream.
Numerous interventional systems and methods that employ a filtration device designed to capture debris during the treatment or diagnosis of vascular disease are well known in the art. The procedure typically involves using a filter delivery catheter to transluminally insert and deliver, within a blood vessel, a filtration device to a location distal of a target site, such as a stenosis or a lesion, and then deploying the filter causing it to open. During such filter delivery process, plaque could be liberated from the walls of the blood vessel and create emboli and thrombi that may enter the bloodstream and potentially occlude distal blood vessels.
After deploying the blood permeable filtration device distal of the target site, an interventional device may be delivered over the guide wire to the target site. During treatment of a stenosis or a lesion within the blood vessel, plaque may be liberated from the walls of the blood vessel creating emboli and thrombi. This debris could then be entrapped in the distally deployed filter, and hinder its removal from the vasculature.
In view of the foregoing, it is desirable to provide an aspirating filter delivery catheter and method for extracting debris during the filter delivery process. It is further desirable to provide an aspirating filter retrieval catheter for extracting debris accumulated proximal of the filter prior to extracting the filter from the vasculature.
The present invention pertains to an aspirating filter delivery catheter deployable in a blood vessel for extracting debris resulting from the filter delivery catheter traversing the target site, such as a stenosis or a lesion. In one embodiment of the invention, the aspirating filter delivery catheter may include a blood permeable filtration device located within the elongated shaft proximate the distal end of the shaft, and one or more aspiration ports located circumferentially and/or longitudinally on the elongated shaft proximate the distal end of the shaft and proximal of the filtration device.
In an alternate embodiment, the aspirating filter delivery catheter may further include an operable end cap at the distal opening of the elongated shaft for minimizing debris collection on the distal side of the filter while the catheter is being advanced to the target site.
The filter delivery catheter may be slidably coupled to a guide wire, and suction may be applied to the proximal end of the elongated shaft for extracting, through the aspiration ports, debris resulting from the distal region of the delivery catheter traversing the target site, such as a stenosis or a lesion.
The present invention also pertains to an aspirating filter retrieval catheter deployable in a blood vessel for extracting debris entrapped on the proximal side of the blood permeable filter to enable collapsing the filter for removal. In one embodiment of the invention, the aspirating filter retrieval catheter may include an elongated shaft having an aspiration lumen traversing the length of the shaft, and also having a short guide wire lumen proximate the distal end of the shaft. The guide wire lumen could be in fluid communication with the aspiration lumen and the lumen of the blood vessel. The guide wire lumen may be used for slidably coupling the filter retrieval catheter to the guide wire, and the distal end of the catheter may be advanced to a region proximal of the filter. Suction may then be applied to the proximal end of the aspiration lumen of the elongated shaft for extracting debris entrapped on the proximal side of the filter.
In an alternate embodiment, the aspirating filter retrieval catheter may further include an inflatable balloon around the elongated shaft proximate the distal end of the shaft. The balloon may be fluidly coupled to an inflation/deflation lumen extending to proximate the proximal end of the retrieval catheter. While applying suction at the proximal end of the aspiration lumen of the elongated shaft, the balloon may be inflated to partially restrict or fully occlude blood flow, thereby potentially increasing the suction pressure for extracting the debris. The balloon may then be deflated.
Next, the filter may be collapsed into a low profile state around the distal end of the filter retrieval catheter, and the catheter with the attached filter may be removed from the vasculature.
The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered in like fashion. Those skilled in the art will recognize that many of the examples provided could have suitable alternatives that may be utilized without departing from the spirit of the disclosed invention.
Using well known percutaneous techniques, guide wire 20, having a proximal end (not shown), a flexible distal tip 22 and a filter stop 24 fixedly attached to guide wire 20, may be manipulated into position within the lumen of a blood vessel 10. In
Elongated shaft 40 includes one or more aspiration ports 50 located circumferentially and/or longitudinally proximate the distal end of elongated shaft 40 and proximal of filtration device 6. As cap 44 passes distally through lesion 12, emboli may be dislodged. Such emboli may flow along paths 52 and enter elongated shaft 40 through aspiration ports 50. The emboli could then be extracted along path 54 by a suction providing means (not shown) fluidly connected to the proximal end (not shown) of elongated shaft 40.
Filtration device 6 may include a self-expanding support hoop 32 with a blood permeable sac 30 and a suspension member 31 attached thereto. The open end of blood permeable sac 30 may be affixed to support hoop 32 such that support hoop 32 forms a mouth through which blood may flow into blood permeable sac 30. Suspension member 31, when connected to support hoop 32 and guide wire 20, could be useful in holding self-expanding support hoop 32 and blood permeable sac 30 in an eccentrically and laterally displaced position relative to the direction of blood flow.
As shown in
As illustrated in
In one embodiment, docking member 216 may be permanently formed on guide wire 20. Alternatively, docking member 216 may be detachably connected to guide wire 20 such as by a friction fit between guide wire 20 and a channel (not shown) of docking member 216, or by a mechanical attachment mechanism. If detachable, docking member 216 may be used on any suitable guide wire, thereby adapting the guide wire for operation with filtration device 6.
Filter support hoop 32 may have a generally circular mouth 154 and a plurality of suspension members, i.e., suspension struts or ribs 31. Mouth 154 may support filter 30, and could be formed of a wire loop coupled thereto via a known bio-compatible adhesive or other suitable means as are well known in the art. Filter mouth 154 may be coupled to collar 156 via suspension member 31 such that collar 154 could slide along guidewire 32 to deploy or retrieve filtration device 6. Suspension struts 31 may be attached to collar 156 and mouth 154 by any suitable means as are well known in the art. Filter frame 32, mouth 154, and suspension ribs 31 could be formed of a wire or strip of a relatively elastic material such as a Nitinol material.
In use, filtration device 6 may be mounted relative to guide wire 20 by inserting guide wire 20 through an opening in cone 232. Filtration device 6 could be advanced over guide wire 20 to align cone 232 with docking member 216. Cone 232 may be forced into channel 220 of docking member 216 until ring 242 snaps into groove 222 and is maintained therein. Filtration device 6 could be inserted in a low-profile collapsed condition via cooperation with sheath 40, and positioned at a treatment site, as comparatively illustrated in
In another embodiment of the present invention, yet another filter stop or docking member may additionally be affixed on guide wire 20, and positioned proximal of collar 156.
In other embodiments, filtration device 6 may be coupled to a filter delivery wire (not shown) for deploying and retracting filtration device 6. To one of ordinary skill in the art, it is well known that numerous alternative embodiments for delivering and retrieving one or more filtration devices are also possible.
From the foregoing descriptions of various embodiments for affixing one or more filter stop or filter docking mechanism on to guide wire 20, it should be apparent that the movement of filtration device 6 may be restricted either in one direction, viz., distally or proximally, or in two directions, viz., both distally and proximally.
It is advantageous for operable end cap 44 to be constructed such that it could be pushed into an open state by applying a relatively light force on the proximal side of interleaving plates 45 of end cap 44. End cap 44 could be opened either by pushing filtration device 6 in the distal direction, or by pulling elongated shaft 40 in the proximal direction, or by a combination thereof. Filtration device 6 may thus exit elongated shaft 40 through the now open operable end cap 44, and placed distal of target site 12 within the lumen of blood vessel 10. Upon exiting delivery catheter 2, self-expanding support hoop 32 may open radially to engage the inside wall of blood vessel 10.
Operable end cap 44 as illustrated in
The foregoing descriptions of the various embodiments have focused around delivery lumen 2 as having one lumen for one or more purposes, viz., guide wire lumen, filter delivery lumen, and aspiration lumen. It should be apparent to those of ordinary skill in the art that delivery lumen 2 may include more than a single lumen, e.g., delivery lumen 2 may have two lumens, for example, one being a guide wire lumen, and the other being a filter delivery and aspiration lumen. Alternately, delivery lumen 2 may include three separate lumens: one being a guide wire lumen, another being a filter delivery lumen, and the other being an aspiration lumen, for example.
Described hereinafter is one of several methods in which aspirating filter delivery catheter 2 may be used in practice. One embodiment of a method of using delivery catheter 2 may include placement of guide wire 20, such that flexible distal tip 22 and filter stop 24 are positioned distally of target site 12 within the lumen of blood vessel 10. Next, aspirating filter delivery catheter 2 including filtration device 6 and operable end cap 44 may be slidably coupled to guide wire 20, and the distal end of delivery catheter 2 advanced toward target site 12.
When the distal end of delivery catheter 2 is proximate the proximal side of stenosis or lesion 12, a suction providing means may be fluidly coupled to the proximal end of elongated shaft 40. The lumen of elongated shaft 40 may provide fluid communication between aspiration ports 50 and the suction providing means. Delivery catheter 2 may be advanced in the distal direction for traversing target site 12, while suction is being administered for extracting, through aspiration ports 50, debris, emboli, thrombi, etc., resulting from the movement of delivery catheter 2.
Next, filtration device 6 may be deployed within the lumen of blood vessel 10 and distal of target site 12 by pushing filtration device 6 in the distal direction and/or pulling delivery catheter 2 in the proximal direction. Operable end cap 44 could be pushed open with filtration device 6 exiting the distal end of elongated shaft 40, and self expanding support hoop 32 may extend radially to engage the inside wall of blood vessel 10. Blood may now enter and flow through blood permeable sac 30, and aspirating filter delivery catheter 2 may be extracted from blood vessel 10.
An interventional device may be introduced over guide wire 20 to target site 12, and one or more vascular procedure such as angioplasty, atherectomy, thrombectomy, stent placement, etc., may be conducted for treating occlusive vascular disease. Any one of these procedures could cause material to dislodge from the inside wall of blood vessels and/or create thrombi, emboli, etc., into the bloodstream. With filtration device 6 deployed distally of stenosis or lesion 12, the debris may enter and get entrapped within blood permeable sac 30. After the procedure has been completed and interventional device removed, the emboli laden filtration device may also be extracted.
Blood permeable sac 30 may contain small and/or large amounts of debris of differing form, size, etc. Under certain circumstances it may be possible to use a conventional filter retrieval catheter to collapse and extract the filtration device from the vasculature with the debris encapsulated within blood permeable sac 30. However, under certain conditions blood permeable sac 30 might become occluded with debris making it relatively difficult to collapse and extract filtration device 6 using a conventional filter retrieval catheter and method. Therefore, there exists a need for an aspirating filter retrieval catheter for extracting, at least in part, some of the entrapped debris so that filtration device 6 may be collapsed for easy removal without releasing debris into the blood stream.
Elongated shaft 70 may include an aspiration lumen 74 therethrough having a proximal end (not shown) and a distal end, and a guide wire lumen 78, also having a proximal end and a distal end, guide wire lumen 78 fixedly attached proximate the distal end of elongated shaft 70. The distal end of guide wire lumen 78 may be fluidly coupled to the distal end of aspiration lumen 74 such that both lumens 74 and 78 commonly form the opening at the distal end of elongated shaft 70. Guide wire lumen 78 may be used for slidably coupling retrieval catheter 60 to guide wire 20. The proximal end of aspiration lumen 74 may be fluidly coupled to a suction providing means (not shown) for extracting debris 80 from blood permeable sac 30.
Balloon 62, having an expanded state and a contracted state is disposed proximate of the distal end of elongated shaft 70. Balloon 62 could be configured such that in the expanded state, surface 64 thereof may engage the inner surface of the lumen of blood vessel 10. As shown in
Described hereinafter is one of several methods by which aspirating filter retrieval catheter 60 may be used in practice. One embodiment of a method of using retrieval catheter 60 may include slidably coupling retrieval catheter 60 to guide wire 20 via guide wire lumen 78. Retrieval catheter 60 may be manipulating within the lumen of blood vessel 10 to place the distal end at a position proximate where suspension strut 31 attaches to guide wire 20.
A suction providing means (not shown) may be fluidly coupled to the proximal end of aspiration lumen 74 (i.e., elongated shaft 70 or retrieval catheter 60) for possibly inducing suction pressure at the distal end. Suction may be started, and debris 80 entrapped within blood permeable sac 30 could be extracted through aspiration lumen 74 along flow path 82.
Under certain circumstances, blood permeable sac 30 may be debris laden such that additional suction pressure may be required for extracting debris 80. In such cases, balloon 62 may be inflated to partly restrict or fully occlude blood flow, thereby enabling an increase in the suction pressure in the region proximate self expanding support hoop 32, and enhancing extraction of debris 80. Suction may either be continuously applied or stopped while filtration device 6 is collapsed to a low profile state and extracted from the vasculature.
Numerous advantages of the invention covered by this document have been set forth in the foregoing description. It will be understood, however, that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of parts without exceeding the scope of the invention. The invention's scope is, of course, defined in the language in which the appended claims are expressed.
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| Number | Date | Country | |
|---|---|---|---|
| 20050033347 A1 | Feb 2005 | US |
