Blood clot filters are used in combination with other thrombolytic agents to treat pulmonary embolism occurring within a patient. Such devices are generally inserted intravenously into a target location of the body (e.g. an artery or vein), and function by capturing blood clots (emboli) contained in the blood stream before they can reach the heart and/or lungs and cause permanent damage to the body. In the treatment of Deep Vein Thrombosis (DVT), for example, such filters are placed in the inferior vena cava to prevent further blood clotting in the large veins of the lower body. Placement of the filter is typically accomplished percutaneously via the femoral arteries or the jugular vein using a local anesthetic, or by performing a laparotomy with the patient under general anesthesia.
In certain designs, an introducer sheath may be used to deliver the blood clot filter through the body. Such introducer sheaths are generally tubular in shape, and include an inner lumen configured to transport the blood clot filter in a collapsed position through the body. Once transported to a desired location within the vasculature, the filter can then be removed from within the introducer sheath, allowing the filter to spring open, or to be expanded, and engage the vessel wall. A needle, hook, barb, prong, wedge or other attachment means disposed on the blood clot filter can be used to secure the filter to the vessel wall.
There are a number of situations in which it may be desirable for a physician to remove the filter once inserted within the body. In certain circumstances, for example, the risk of pulmonary embolism may be relatively short term (e.g. about two weeks), thus requiring insertion of the filter for only a short period of time. Permanent implantation of the filter in such cases may unnecessarily impede the flow of blood within the vessel, and can lead to further thrombosis growth at the filter implantation site. In other circumstances, it may be desirable to reposition the filter within the vessel, or to replace the existing filter with a new filter.
This disclosure pertains generally to retrievable filter devices implantable within a lumen. Associated deployment/retrieval apparatus and methods for retrieving and/or repositioning the filter device within the body are also disclosed herein.
In some embodiments, this disclosure relates to an implantable filter having a first generally apical hub, a first plurality of solid legs each having a proximal end, a distal end region, and an intermediate region therebetween, said first plurality of solid legs being fixedly attached to the first generally apical hub and having a first configuration in which the solid legs are substantially parallel and a second configuration in which the distal ends of at least some the first plurality of solid legs are radially expanded relative to a central axis passing through the first generally apical hub; and a second plurality of wires each having distal ends and proximal ends, said wires of the second plurality of wires being fixedly attached at their proximal ends to a second generally apical hub which is slidably moveable relative to the first generally apical hub, wherein each of the second plurality of wires is individually associated with one of the solid legs of the first plurality of solid legs at the intermediate region thereof and distal end region thereof, further wherein the association of each wire with the solid leg at the distal end region thereof comprises the wire passing transversely through the distal end region of the solid leg such that each wire has a first position in which the distal end of the wire protrudes radially outward from the distal end region of the solid leg and a second position in which the wire does not protrude significantly radially outward from the distal end region of the solid leg.
In other embodiments, this disclosure relates to an implantable filter comprising a generally apical hub; a plurality of legs each having a proximal end, a distal end region, and an intermediate region therebetween, said legs being fixedly attached to the generally apical hub and having a first configuration in which the legs are substantially parallel and a second configuration in which the distal ends of at least some the plurality of legs are radially expanded relative to a central axis passing through the apical hub; a pair of first struts attached to a first leg and a second leg of the plurality of legs within the respective intermediate regions of the first and second legs and extending to a first join proximal to their distal ends; a pair of second struts attached to a first leg and a second leg within the respective intermediate regions of the first and second legs and extending to a second join distal to their proximal ends; and a wire extending from the first join and slidingly received through an aperture associated with the second join, wherein upon radial expansion of the first and second leg to the second configuration the first join and the second join are configured to move generally toward one another whereby the wire protrudes from the second join in a direction radially outward from the central axis passing through the apical hub.
In another aspect, this disclosure relates to method of deploying a filter comprising positioning the filter within a distal region of a catheter; positioning the distal region of the catheter within a lumen containing a fluid to be filtered; ejecting the filter from the catheter thereby allowing at least some the distal ends of the plurality of solid legs to become radially expanded relative to a central axis passing through the apical hub; and implanting the distal ends of the plurality of wires in a wall of the lumen containing a fluid to be filtered.
In yet another aspect, this disclosure relates to a method of retrieving a filter comprising positioning a distal region of a catheter proximally adjacent to a first generally apical hub of the filter; moving the first generally apical hub of the filter axially relative to a second generally apical hub, thereby withdrawing a plurality of wires relative to a plurality of solid legs thereby moving the plurality of wires from first position in which the wires protrude significantly radially outward from the distal end region of the solid legs to a second position in which the distal ends of the wires do not significantly protrude radially outward from the distal end region of the solid legs thereby at least partially withdrawing the wire from the wall of the lumen; withdrawing the filter to a position at least partially within a distal region of the catheter; and withdrawing the catheter and the filter of claim 1 from the lumen.
Although described herein in the context of a temporary vena cava filter, it will be understood that the anchorage system disclosed may be used to provide permanent or temporary anchorage for a variety of endoluminal devices which are not necessarily limited to blood vessels.
The following description should be read with reference to the drawings wherein like reference numerals indicate like elements throughout the several views. The drawings, which are not necessarily to scale, are not intended to limit the scope of the claimed invention. The detailed description and drawings illustrate example embodiments of the claimed invention.
All numbers are herein assumed to be modified by the term “about.” The recitation of numerical ranges by endpoints includes all numbers subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include the plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it would be within the knowledge of one skilled in the art to effect such feature, structure, or characteristic in connection with other embodiments, whether or not explicitly described, unless cleared stated to the contrary.
The filter legs 300 may be fabricated separately and attached to a separate first generally apical hub 100 or the first generally apical hub 100 and filter legs 300 may be formed as an integral unit from a hypotube by laser cutting, etching, and the like. The filter legs 300 and the first apical hub 100 may be formed from materials commonly used for that purpose such as nickel titanium alloy, stainless steel, biocompatible polymers, and the like. The filter legs 300 may optionally be biased to self-expand upon deployment or may be actuated to expand by mechanical or thermal means.
In some embodiments, the first generally apical hub 100 includes a hook 110, illustrated in
Each wire 400 is each disposed generally along and somewhat parallel to one of the plurality of filter legs 300 and passes from one side of the leg to the other before passing through a distal opening 320. In some embodiments, a wire 400 may pass transversely through or alongside its associated leg two or more times between the first generally apical hub and the distal end of the leg. For example, a wire 400 may pass from a position radially outside of the leg through an aperture 310 in an intermediate region of said leg 300 and thence along the leg 300 to and through a second aperture 320 to extend radially outward through the leg 300 forming an anchoring barb 410 as illustrated in
The term “wire” is to be interpreted as including structures comprising two or more components which, when joined, provide the features of a wire 400 as described herein. Wires 400 and the second apical hub 200 may comprise materials commonly used for those purposes such as nickel titanium alloy, stainless steel, biocompatible polymers, and the like. In many embodiments the distal tip 410 may be formed from a material which minimizes the adhesion of the wire tip 410 to the lumen wall. The adhesion minimizing material may be either the material from which the wire tip 410 is formed or a coating (not shown) thereon.
Axial movement of the first generally apical hub 100 relative to the second generally apical hub 200 may cause the wire 400 and distal tip 410 to retract relative to the associated leg 300 thereby withdrawing the distal tip 410 from the wall of the lumen in which the filter is deployed. In some embodiments, the distal tip 410 will be withdrawn from the lumen wall along the axis of the wire tip 410 thereby minimizing the extraction force required. In other embodiments, the distal tip 410 may be adapted to pivot to withdraw from the lumen wall. In yet other embodiments, the distal tip 410 may both withdraw axially while pivoting to a degree. In some embodiments, the leg 300 may include an enlarged region which may serve as a landing pad to limit the penetration of the wire tip 410 and to reduce the likelihood of the distal end of the filter legs 300 becoming engulfed by tissue overgrowth or other deposits.
It will be appreciated that the filter 10 of these embodiments may be deployed with the wire tip(s) 410 in either the first extended position or the second retracted position. If the filter 10 is deployed with wire tips 410 in the first position, the outward expansion of the filter legs 300 may serve to anchor the wire tip 410 in the lumen wall. In the alternative, the filter 10 may be deployed in the second retracted position and the wire tip(s) 410 may subsequently be extended to engage the lumen wall by moving first generally apical hub 100 relative to second generally apical hub 200. If or when it becomes desirable to remove the filter 10 from engagement with the lumen wall, either permanently or for repositioning, the wire tip(s) 410 may subsequently be retracted to disengage from the lumen wall by moving first generally apical hub 100 relative to second generally apical hub 200 in the opposite sense.
A number of non-limiting configurations of distal ends of filter legs 300 are illustrated in
In other embodiments, the alternating diagonal segments of filter leg 300 may direct the intervening longitudinal segments toward and away from the lumen wall and the tubular elements 312 may be disposed along the diagonal segments to allow the generally straight wire 400 to weave alternately between the inner and outer surface of the leg 300 before passing outward through aperture 320 to engage the lumen wall. In yet other embodiments, one or more of the illustrated tubular elements 312 may be omitted and the leg 300 may be viewed as twining about wire 400 to create an extended intermediate region.
In another aspect, the disclosure relates to an implantable filter system, as partially depicted in
When it is desirable to remove or reposition implantable filter 10, catheter 800 may be advanced to a position just proximal of the proximal end of implanted filter 10. In some embodiments, catheter 800 may include alignment elements (not shown) to ensure alignment of catheter 800 with implanted filter 10. For example, the distal end of catheter 800 may include radially expansible guides which locate the first apical head. In some embodiments, separate elements of manipulation element 820 may provide that function when extended sufficiently from the distal end of catheter 800. Releasable actuator 810 may then be advanced to engage hook 110 of the embodiment of
Although the illustrative examples described above relate to a filter implantable in a body lumen, additional applications are also contemplated. In such an embodiment, the size of the filter may be adjusted to correspond to the size of the lumen of, for example, a piece of tubing or a pipe. Further, although the exemplary filters discussed above have been illustrated as having configurations in which the legs expand symmetrically to position the filter such that its central axis generally coincides with the central axis of the lumen in which it is deployed, it is to be understood that embodiments in which one or more legs of the filter are disposable generally parallel to and potentially in contact with the lumen wall such that the central axis of the filter lies at an angle to the central axis of the lumen are also contemplated.
In addition to the elements discussed above, the implantable filters may include other elements commonly employed in such filters. For example, the filter and/or the catheter portion of the system may include one or more radiopaque markers. Similarly, in some embodiments, the filter may include a filter membrane, functional coatings, and the like.
Various modifications and alterations of this invention will become apparent to those skilled in the art without departing from the scope and principles of this invention, and it should be understood that this invention is not to be unduly limited to the illustrative embodiments set forth hereinabove. All publications and patents are herein incorporated by reference to the same extent as if each individual publication or patent was specifically and individually indicated to be incorporated by reference.
Number | Date | Country | |
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61467675 | Mar 2011 | US |