SYSTEMS AND METHODS FOR VASCULAR FILTER RETRIEVAL
Apparatus and methods for retrieving a vascular filter from a vessel are provided wherein a retrieval adapter is delivered to a treatment site concurrently along with an interventional device to reduce the number of steps required to remove the vascular filter. The retrieval adapter also reduces the possibility of entangling the vascular filter with a stent disposed within the vessel during removal of the vascular filter. A separate retrieval catheter is also described for use in conjunction with the retrieval adapter.
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This is a continuation of U.S. Ser. No. 10/684,942, filed Oct. 14, 2003; which is a continuation of U.S. Pat. No. 6,663,651, filed Jan. 16, 2001 and thus claims priority thereof.
FIELD OF THE INVENTIONThe present invention relates to apparatus and methods for retrieving a vascular device, such as a filter, from within a vessel. More particularly, the present invention provides apparatus useful for retrieving a vascular filter used to prevent embolization associated with diagnostic or therapeutic interventional procedures, thrombectomy and embolectomy.
BACKGROUND OF THE INVENTIONPercutaneous interventional procedures to treat occlusive vascular disease, such as angioplasty, atherectomy, and stenting, often dislodge material from the vessel walls. This dislodged material, known as emboli, enters the bloodstream and may be large enough to occlude smaller downstream vessels, potentially blocking blood flow to tissue. The resulting ischemia poses a serious threat to the health or life of a patient if the blockage occurs in critical tissue, such as the heart, lungs, or brain.
The deployment of stents and stent-grafts to treat vascular disease, such as aneurysms, involves the introduction of foreign objects into the bloodstream, and also may result in the formation of clots or release of emboli. Such particulate matter, if released into the bloodstream, also may cause infarction or stroke.
Numerous blood filters are known that are designed to capture material liberated from vessel walls during the treatment of vascular disease. Such treatment procedures, such as angioplasty, atherectomy and stenting, typically involve transluminally inserting an interventional device to the treatment site along a guidewire. Upon completion of the procedure, the interventional device is removed from the patient's blood vessel, and a retrieval mechanism, such as a sheath, is advanced along the guidewire in order to retrieve the blood filter.
One drawback associated with using a sheath to retrieve a filter is that the retrieval process requires two steps: (1) the interventional device (e.g., angioplasty catheter) must be removed and (2) the retrieval sheath must then be advanced along the guidewire to retrieve the filter. This additional exchange adds time to the length of the procedure, involves introduction of an additional element (the retrieval catheter) into the patient's vasculature, and enhances the risk of dislodging the filter and permitting emboli to escape therefrom.
Moreover, as the retrieval sheath is advanced along the guidewire, its distal end may become entangled with a stent disposed within the patient's vessel. If, for example, a stent has been deployed, the distal end of the retrieval sheath may inadvertently engage a stent strut, preventing further advancement of the retrieval sheath within the vessel, or even possibly causing vessel dissection.
One disadvantage associated with attempting to retrieve a vascular filter using the guidewire lumen of an interventional device, such as an angioplasty catheter, is that the diameters of such lumens are typically quite small, e.g., 0.014 inch. Accordingly, it is not possible to retrieve previously known vascular filters using the guidewire lumens of most interventional devices.
In view of the foregoing, it would be desirable to provide improved apparatus and methods that streamline retrieval of a vascular filter.
It further would be desirable to provide improved apparatus and methods that facilitate retrieval of a vascular filter, with reduced risk of entangling a retrieval sheath in a deployed stent.
SUMMARY OF THE INVENTIONIn view of the foregoing, it is an object of the present invention to provide improved apparatus and methods that streamline retrieval of a vascular filter.
It is another object of the present invention to provide improved apparatus and methods that facilitate retrieval of a vascular filter, with reduced risk of entangling a retrieval sheath in a deployed stent.
These and other objects of the present invention are accomplished by providing a retrieval apparatus that reduces the time and effort required to retrieve a vascular filter from a patient's vessel.
In one preferred embodiment, the present invention includes a retrieval adapter having a proximal end configured to be fitted to the end of an interventional device, such as an angioplasty catheter, and a radially expandable distal end. Upon completion of an interventional procedure such as angioplasty, the balloon of the angioplasty catheter is deflated and the angioplasty catheter then is advanced along the guidewire until the adapter captures the vascular filter.
Alternatively, upon completion of the interventional procedure, the guidewire and attached vascular filter may be withdrawn proximally until the vascular filter engages and is caused to be collapsed by the adapter. Once the vascular filter is collapsed, the vascular filter is partially withdrawn within the adapter, and the vascular filter, adapter, interventional device and guidewire are all removed from the vessel. This streamlined procedure provides a substantial improvement over previously known systems, which typically require exchanging the interventional device for a retrieval sheath before retrieving the vascular filter from the treatment site.
In another embodiment, the retrieval adapter of the present invention may be loaded directly onto the guidewire having the vascular filter so that the adapter is delivered to a treatment site concurrently with the filter. After completion of a diagnostic or therapeutic procedure involving an interventional device, such as an angioplasty catheter, the interventional device is advanced along the guidewire. As the distal end of the interventional device moves distally, it abuts against the adapter and urges the adapter into contact with the filter, thereby causing the adapter to collapse and capture the vascular filter. Alternatively, as for the previous embodiment, the interventional device may be held stationary and the vascular filter and adapter retracted proximally.
In yet another embodiment, the present invention includes a retrieval catheter having proximal and distal ends. The proximal end of the catheter is loaded onto the distal end of an interventional device, and that assemblage then is loaded onto the guidewire having the vascular filter. After completion of a diagnostic or therapeutic procedure, such as stent deployment, the retrieval catheter is advanced over the working element of the interventional device (e.g., the deflated balloon) and the vascular filter. Alternatively, the retrieval catheter may be held stationary and the vascular filter and guidewire retracted proximally to collapse and capture the filter in the retrieval sheath.
The above and other objects and advantages of the present invention will be apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which like reference characters refer to like parts throughout, and in which:
The present invention is directed to apparatus and methods for closing the mouth of a vascular filter or similar vascular device so as to prevent emboli from escaping during contraction and removal of the vascular filter or device, while reducing the number of equipment exchanges associated with such removal.
A number of vascular filters are known for providing distal protection against embolization in conjunction with a transluminal diagnostic or therapeutic procedure, such as angioplasty. These filters generally are deployed distal to a vascular lesion prior to undertaking a diagnostic or therapeutic procedure, and are designed to filter emboli liberated during the procedure from the patient's blood. A brief description of a number of these filters is provided as context for advantages achievable using the apparatus of the present invention.
Referring now to
Vascular filter 30 preferably includes self-expanding support hoop 31 mounted on suspension strut 32, and supports blood permeable sac 33. Blood permeable sac 33 comprises a biocompatible polymeric material having a multiplicity of pores. Suspension strut 32 is affixed at proximal end 34 to tube 35, and positions support hoop 31 approximately concentric to tube 35 when disposed in a substantially straight length of vessel, but advantageously permits the support hoop to become eccentrically displaced relative to support tube 35 when the filter is deployed in a curved vessel.
Distal end 36 of blood permeable sac 33 is illustratively mounted to nose cone 37, which is in turn mounted to tube 35. Filter 30 is mounted on guidewire 38 between proximal stop 39 and enlarged floppy tip 40 of the guidewire, which functions as a distal stop. Tube 35 permits guidewire 38 to rotate independently of filter 30, thereby permitting floppy tip 40 of the guidewire to be directed within the vessel without causing the blood permeable sac to become wrapped around guidewire 38.
Referring now to
Adapter 50 preferably includes curved distal end 51 having expansion slits 52, opening 53, tubular body 54 having internal lumen 55, and tapered proximal region 56. Optionally, adapter 50 may include helical coil 57 embedded in wall 58 to reinforce the adapter. Adapter 50 preferably is constructed of a thin biocompatible material, such as polyethylene, polypropylene, polyurethane, polyester, polyethylene terephthalate, nylon, polytetrafluoroethylene, or Pebax.RTM., however, any other suitable biocompatible material or a combination of such materials may be used, if desired.
Adapter 50 preferably is constructed so that it has sufficient stiffness to be urged along guidewire 59 and through curved vasculature within a patient's circulatory system. Tapered proximal region 56 enables adapter 50 to be coupled to a conventional interventional device, such as an angioplasty catheter or stent delivery catheter. Adapter 50 has sufficient stiffness so as to not buckle or kink when being urged into engagement with a previously deployed vascular filter during filter retrieval.
Distal end 51 preferably has a smooth, rounded tip to reduce the risk of adapter 50 from catching a flap of dissected tissue or on a stent deployed within a vessel. Expansion slits 52 permit the curved portions of distal end 51 to expand to accept a vascular filter when adapter 50 is advanced along guidewire 59, so that opening 53 at least partially accommodates a portion of a deployed vascular filter. Adapter 50 optionally may comprise a radiopaque material, e.g., a barium sulfate-infused (BaSO.sub.4) polymer or by using metal markers, to permit viewing of the adapter using a fluoroscope. In addition, coil 57 also may comprise a radiopaque material.
Tapered region 56 is configured so that it engages the interior or exterior surface of a conventional interventional device, such as an angioplasty catheter or stent delivery system. Tapered region 56 also aids in disposing adapter 50 concentric with respect to guidewire 59. In accordance with the principles of the present invention, adapter 50 is delivered at the same time as an interventional device to be used for the diagnostic or therapeutic treatment. Accordingly, adapter 50 provides a significant improvement over previously known filter retrieval systems, by eliminating the need for a separate catheter exchange to retrieve the vascular filter.
Optionally, adapter 50 may be bonded to the distal end of the interventional device using a standard biocompatible adhesive, press fitting, or other suitable means. For example, the internal surface of lumen 55 at tapered proximal end 56 may be coated with a pressure-sensitive adhesive. A clinician may then couple adapter 50 to the distal end of an interventional device and apply pressure to fix the adapter to the device. The adapter then is delivered with the interventional device, and upon completion of the diagnostic or therapeutic procedure, is used to retrieve the vascular filter. Alternatively, adapter 50 may be provided in a kit including a vascular filter mounted on a guidewire (not shown).
Referring now to
With respect to
The degree to which vascular filter 30 is enclosed within adapter 50 may be varied depending on treatment requirements. This may be accomplished by altering the size of adapter 50 or by controlling the movement of catheter 60 along guidewire 38. For example, in some cases it may be sufficient to enclose the mouth of filter 30 within adapter 50 to facilitate retrieval. In such a situation, adapter 50 may be constructed so that it is somewhat smaller than the length of filter 30, so only the mouth of the device fits into the adapter. In other situations, however, it may be desired to enclose some or all of filter 30 within adapter 50, and in such a case adapter 50 may be constructed so that it is somewhat larger than the length of vascular filter 30.
Referring now to
Body 71 preferably is fabricated from a thin biocompatible material, such as polyethylene, polypropylene, polyurethane, polyester, polyethylene terephthalate, nylon, polytetrafluoroethylene, polyimid, or Pebax.RTM. Body 71 also is sufficiently stiff to be advanced along a guidewire through curved vasculature, and to retrieve a vascular filter, without buckling or kinking. Retrieval catheter 70 may be made radiopaque by using metal marker 73 or by constructing it of a radiopaque material such as a barium sulfate-infused (BaSO.sub.4) polymer.
Retrieval catheter 70 may be mounted over a conventional interventional devices, such as an angioplasty catheter or stent delivery system, prior to inserting the interventional device into the patient's vasculature. For example, to mount retrieval catheter 70 on an angioplasty catheter, the distal end of the angioplasty catheter is inserted through distal end 75 of body 71, and the body then is retracted proximally on the angioplasty catheter until body 71 is disposed proximally of the balloon of the angioplasty catheter, as shown in
A first mode of using retrieval catheter 70 is now described with respect to
As shown in
Next, as shown in
As shown in
In
Each of adapters 50, 80, 90 and 100 may be coupled to (or disposed adjacent to) the distal end of an interventional catheter so that the adapter is delivered to a treatment site at the same time as the working element (i.e., balloon or stent) of the interventional device. Such concurrent delivery eliminates the steps of removing the interventional device from the patient's vessel and inserting a separate retrieval sheath to the treatment site along the guidewire.
Referring now to
In operation, an interventional device may be advanced along guidewire 38 until it abuts proximal end 114 of adapter 110, pushing the adapter distally along suspension strut 32 towards support hoop 31 of filter 30, until support hoop 31 is received within lumen 112. The extent to which adapter 110 receives support hoop 31 may of course be determined by the length of adapter 110. Alternatively, adapter 110 may collapse and retrieve vascular filter 30 by retracting guidewire 38 such that filter 30 is retracted proximally towards the adapter while holding the interventional device stationary.
Interventional device 60 then is used to perform the desired diagnostic or therapeutic treatment, during which emboli E may become dislodged from the vessel wall. Those emboli travel with antegrade blood flow and are captured in blood permeable sac 33 of filter 30. After completion of this procedure, the balloon of the interventional device is deflated and the interventional device is advanced along guidewire 38 in the distal direction to bring distal end 61 of the interventional device into abutment with tapered proximal region 114 of adapter 110, as shown in
With respect to
The degree to which vascular filter 30 is captured in adapter 110 depends on the length of lumen 112 within adapter 110 and also is limited by the length of the support hoop when folded over guidewire 38. Specifically, vascular filter 30 may be received within lumen 112 of adapter 110 until the point on support hoop 31 opposite to the connection to suspension strut 32 is urged against guidewire 38.
Because closing the vascular filter may prevent the vascular device from being re-deployed, it may be desirable to prevent the inadvertent closing of vascular filter 30. Such inadvertent closing may be prevented by using a safety system deployed along guidewire 38, as shown in the embodiment of
In
Safety system 120 is intended to prevent an interventional device, such as a balloon catheter or stent delivery system, from accidentally closing vascular filter 30. Screw 122 and stop 126 preferably are fixed on guidewire 38, while nut 124 is configured to move freely along guidewire 38 between screw 122 and stop 126. Stop 126 restricts movement of nut 124 in the proximal direction, while screw 122 selectively restricts movement of nut 124 in the distal direction.
Nut 124 may be advanced past screw 122 by rotating guidewire 38 such that the threads of the screw mesh with the threads of the nut, thus advancing the nut over and past the screw until the nut is disposed distally of the screw, i.e., between filter 30 and screw 122. When nut 124 is disposed between screw 122 and stop 126, it prevents the interventional device from advancing distally toward adapter 110 until guidewire 38 is intentionally rotated. Once the intended diagnostic or therapeutic procedure is completed, however, nut 124 is moved to a position between filter 30 and screw 122 by rotating guidewire 38, and then the interventional device may be advanced distally over stop 126 and screw 122 to urge nut 124 into engagement with adapter 110, thereby closing filter 30.
After completion of this procedure, the balloon of the interventional device is deflated and the interventional device is advanced along guidewire 38 in the distal direction and over stop 126 until distal end 61 of the interventional device contacts nut 124. The distal end of interventional device 61 may push nut 124 until it is in direct contact with screw 122.
Next, as shown in
Although the present invention is illustratively described in the context of interventional devices such as angioplasty catheters and stent delivery systems, the apparatus of the present invention advantageously may be employed with atherectomy catheters, embolectomy catheters, vascular mapping catheters or any other suitable diagnostic or therapeutic interventional device, if desired.
Although preferred illustrative embodiments of the present invention are described above, it will be evident to one skilled in the art that various changes and modifications may be made without departing from the invention. It is intended in the appended claims to cover all such changes and modifications that fall within the true spirit and scope of the invention.
Claims
1. Apparatus for use in conjunction with an interventional device in retrieving a vascular filter disposed on a guidewire from a vessel, the apparatus comprising: a retrieval adapter having a proximal end, a distal end and a lumen, the retrieval adapter configured to be disposed on a distal region of the guidewire so that the proximal end engages a distal end of the interventional device, the retrieval adapter configured to receive at least a portion of the vascular filter within the lumen during retrieval of the vascular filter from the vessel.
Type: Application
Filed: Dec 22, 2009
Publication Date: Apr 22, 2010
Applicant: INCEPT LLC (San Mateo, CA)
Inventors: Jeff A. Krolik (Campbell, CA), Amr Salahieh (Campbell, CA), Jackson F. Demond (Santa Cruz, CA), Farhad Khosravi (San Mateo, CA)
Application Number: 12/645,156
International Classification: A61F 2/01 (20060101);