Method of inserting a vein filter
10159556 ยท 2018-12-25
Assignee
Inventors
- James F. McGuckin, Jr. (Radnor, PA)
- James Erich Bressler (Langhorne, PA, US)
- John D. Leedle (Philadelphia, PA, US)
- Colin Valentis (Penndel, PA, US)
Cpc classification
A61F2/0105
HUMAN NECESSITIES
International classification
Abstract
A method of implanting a vessel filter by a femoral approach comprising the steps of providing a sheath with a pusher and the vessel filter positioned therein and providing a sheath centering structure movable within the sheath. The centering structure has a distal portion expandable from a collapsed position within the sheath to an expanded position outside the sheath. The steps further include inserting the sheath into the vessel, moving the centering structure with respect to the sheath to enable the centering structure to move from the collapsed position to the expanded position to move a distal tip of the sheath away from a vessel wall and to a more centered position, and subsequently exposing the vessel filter from the sheath to enable the filter to move from a collapsed position to an expanded position. An implantation system is also provided.
Claims
1. An implantation system for a vascular implant comprising: a sheath having a longitudinal axis, a lumen formed therein and a distal opening; a pusher comprising a lumen and positioned within the sheath, the pusher in contact with the vascular implant to deliver the implant from the sheath, the implant moving from a reduced profile position within the sheath to an expanded placement position outside the sheath, the implant configured for deployment through the distal opening in the sheath for implantation in a patient's body; and a sheath centering structure including an elongated portion and a plurality of arms extending from a distal portion of the elongated portion, the sheath centering structure being slidably positioned within the lumen of the pusher, the arms movable from a reduced profile position to an expanded position to move the sheath away from a vessel wall to a more centered position, the centering structure movable relative to the pusher; wherein in the collapsed position the plurality of arms are positioned proximally of the distal opening of the sheath and the implant, and in the expanded position the plurality of arms are positioned distally of the distal opening of the sheath and the implant.
2. The system of claim 1, wherein the pusher includes a stepped portion forming a shoulder to support the implant.
3. The system of claim 1, wherein the centering structure is movable independent of the pusher and is movable through the implant.
4. The system of claim 1, wherein the arms of the centering structure are joined at an apex, extend distally from the elongated portion and bow radially outwardly, and terminate in free ends.
5. The system of claim 1, wherein the arms of the centering structure are joined at a proximal apex, extend distally from the elongated portion and bow radially outwardly, and converge at a distal end to form a basket like structure.
6. The system of claim 1, wherein the implant comprises a vessel filter, the filter moving to an expanded configuration when deployed from the sheath.
7. The system of claim 1, wherein the plurality of arms are configured to collapse within the lumen of the pusher when transitioning from the expanded position to the collapsed position.
8. In combination, a delivery sheath, a filter, a pusher and a centering structure, the combination comprising: the delivery sheath having a lumen therein dimensioned to receive the filter; the filter positioned within the delivery sheath and configured for deployment through a distal opening in the delivery sheath for implantation in a patient's body; the pusher comprising a lumen and slidably positioned with respect to the delivery sheath, the pusher engaging the filter for deployment of the filter from the delivery sheath; and the centering structure slidably positioned with respect to the filter, pusher and delivery sheath, the centering structure being slidable within the lumen of the pusher, the centering structure having an expandable distal portion to aid centering of the delivery sheath and thus centering of the filter upon delivery from the delivery sheath; wherein the expandable distal portion is collapsed when positioned proximally of the distal opening of the delivery sheath and the implant and expanded when positioned distally of the distal opening of the delivery sheath and the implant.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) Preferred embodiment(s) of the present disclosure are described herein with reference to the drawings wherein:
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DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
(23) Turning now to the drawings, wherein like reference numerals identify similar or like components throughout the several views, a method of implanting vein filters is disclosed. The filter is inserted via a femoral approach. In commonly assigned U.S. Pat. Nos. 7,704,266 and 8,162,972, the entire contents of each of which are incorporated herein by reference, various embodiments of filters are described with various structures. The delivery system of the present invention can be used to insert the filters disclosed in these patents as well as used to insert other filters.
(24) As is common, the term proximal used herein refers to the part closer to the user, e.g., surgeon, and the term distal refers to the part further from the user. Thus, for example, the distal opening of the delivery sheath is the part further from the user as the proximal end extends from the patient's body for manipulation by the user.
(25) Turning initially to
(26) Delivery sheath (catheter) 20 has a distal tip 24 and a distal opening 26 at distal portion 22 (
(27) The filter pusher 30 has a distal tip 32 and a lumen 34 extending therethrough (see
(28) The pusher 30 can be formed from a tube. In a preferred embodiment, the pusher 30 can be formed of Pebax material. The centering wires can be composed of stainless steel. Other materials and compositions of the pusher and wires are contemplated. A wire protruding beyond the distal end of the pusher 30 also can serve as a guidewire. The wire can also help keep the vessel engaging hooks of the filter separated during insertion. A marker band or other indicia can be provided to provide a visual indication of when the filter is at the distal end of the sheath (when the markings are adjacent a proximal end of a filter cartridge). Note in some embodiments, the centering wire can be attached to a hub of the pusher for slidable movement, e.g., by a control knob, such as in the embodiment described below.
(29) The centering structure is designated by generally by reference numeral 40 and has a distal portion 42 and a proximal portion extending outside the body for manipulation by the user. Distal portion 42 includes a plurality of centering arms 44, joined at apex 46, bowing radially outwardly and terminating in free ends 48 (
(30) In one embodiment, the centering structure 40 is formed by a series of wires, e.g., an elongated wire 43 with centering arms 44 formed of separate wires and attached to a distal portion of the wire 43 at apex 46 such as by welding, crimping, soldering, bonding or other known methods. Alternatively, the elongated wire 43 can form one of the centering arms and then additional centering arms 44 can be attached to a region of the elongated wire 43 slightly proximal of its distal tip (as in the location of apex 46). The centering structure can alternatively be formed integrally from a monolithic wire or hypotube. The one piece structure can be laser cut and shape set.
(31) The wires of the centering structure can be made of shape memory material such as Nitinol. In this manner, the wires are collapsed into a low profile position where the arms 44 are substantially aligned with a longitudinal axis of the delivery sheath 20 for delivery. When advanced from the sheath 20, the centering wires are exposed and return to their shape memorized expanded configuration (position) of
(32) Note in the expanded position, the apex 46 can be exposed; alternatively the apex 46 can remain within the confines of the sheath 20 or pusher 30.
(33) As shown, when the centering wires expand, they have a transverse dimension sufficiently large to contact, preferentially circumferentially, the wall of the vessel, thereby keeping the delivery sheath 20 and distal tip 32 of the pusher 30 substantially centered within the vessel. It should be appreciated that the term substantially centered as used herein includes exactly centered within the vessel as well as slightly off center such as at an angle of up to about 30 degrees with respect to the longitudinal axis of the vessel, but preferably smaller. By keeping this angle closer to zero, centering of the delivery sheath distal tip 24 and distal opening 26, and therefore the filter 100 when delivered, can better be achieved.
(34) An alternate embodiment of the centering structure is illustrated in
(35) Centering structure 140 differs from centering structure 40 in that it is a closed loop design. More specifically, distal portion 142 includes a plurality of centering arms 144, joined at proximal apex 146 and at distal converging region 147. The connection at distal region 147 provides more structural integrity. Centering arms 144 bow radially outwardly between their proximal and distal fixed points. In a preferred embodiment, three centering arms 144 are provided, however, a fewer or greater number of arms can alternatively be provided. The centering structure 140 is slidably positioned within a lumen of the filter pusher 130 (similar to lumen 34 of pusher 30) and therefore moves, e.g., slides, relative to the pusher 130, sheath 120 and filter 100. That is, the centering structure 140 is movable from a retracted position within the delivery sheath 120 to an extended (advanced) or exposed position where it extends beyond the distal tip of sheath 120 for movement from a collapsed position to the expanded position of
(36) In one embodiment, the centering structure is formed by a series of wires, e.g., an elongated wire 143 (
(37) The wires of the centering structure can be made of shape memory material. In this manner, the wires are collapsed into a low profile position where the arms 144 are substantially aligned with a longitudinal axis of the delivery sheath 120 for delivery. When advanced from the sheath 120, the wires are exposed and return to their shape memorized expanded configuration (position) of
(38) As shown, when the wires expand, the have a transverse dimension sufficiently large to contact the wall of the vessel, thereby keeping the delivery sheath 120 and distal tip 122 of pusher 120 substantially centered within the vessel. Substantially centered as noted above includes exactly centered as well as slightly off center such as at an angle of up to 30 degrees with respect to the longitudinal axis, but preferably smaller. By keeping this angle closer to zero, centering of the opening of the delivery sheath 120, and therefore the filter 100 when delivered, can better be achieved.
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(40) Turning to the embodiment of
(41) In the embodiment of
(42) The centering structures described herein are self-expanding, e.g., composed of a shape memory material that automatically returns to the expanded position of
(43) The use of the filter implantation system will now be described. It should be understood that the method of use will be described in conjunction with the centering structure 40 of
(44) In use, once the sheath 20 and dilator (not shown) are inserted through the femoral vein and advanced through the iliac vein into the inferior vena cava, the dilator is removed. Due to the anatomy of the particular patient's vena cava C, the sheath 20 may end up off center such as against the vessel wall V such that distal opening is close to the vessel wall (see
(45) Note that during intravascular insertion of the sheath 20 into the vena cava C, filter pusher 30, filter 100 and centering structure 40 positioned therein are fully covered by sheath 20 so as not to be exposed (
(46) Next, the centering structure 40 is advanced distally from the sheath 20 (
(47) The filter 100 is exposed from the sheath 20 (
(48) Once the filter 100 is fully deployed in the vessel, the centering structure 40 is then retracted proximally by the user, and the centering arms 44 are thereby collapsed within the lumen 34 of the pusher 30 as it is withdrawn through the pusher 30 and into the sheath 20 (
(49) Note the Figures illustrate filter 100 identical to the filter of U.S. Pat. No. 8,162,972 incorporated by reference above as one example of a filter that can be utilized with the delivery system of the present invention Thus, filter 100 is preferably formed from a single tube, and is preferably composed of shape memory material such as Nitinol. A plurality of cutouts are formed in the filter 100, preferably by laser cutting, although other techniques are contemplated to thereby form struts 114.
(50) Filter 100, as shown in the expanded configuration of
(51) The struts 114 of filter 1010 terminate in hooks 172. In some embodiments, some struts can terminate in a hook larger than the hook of other struts. In some embodiments, the struts 114 can terminate in alternating larger and smaller hooks such that every other strut 114 would terminate in a small hook and the other struts (in between) would terminate in a larger hook. The penetrating tips 176 of hooks 172 penetrate the tissue to retain the filter, preferably temporarily, and point toward the cranial end of the filter.
(52) The six filter struts or strut portions 114 extend longitudinally and then curve outwardly from tubular portion 118, extend radially therefrom and divide into two connecting filter struts or strut portions 114a, 114b (preferably of equal width, although differing dimensions are contemplated) that angle way from each other (in different directions) to extend to the connecting strut portion of an adjacent strut 114. Thus, connecting strut portion 114a of one strut 114 interconnects with the connecting strut portion 114b of an adjacent strut at joining region 114d. This forms closed geometric shapes 125, preferably substantially diamond shaped in configuration. For clarity, not all of the identical parts are labeled in the drawings.
(53) In the illustrated embodiment, preferably six struts are provided forming twelve interconnecting struts; however a different number of struts and closed geometric shapes can be provided. Note that although all six struts 114 are shown interconnected, it is also contemplated that fewer than all the struts can be interconnected. Also, the strut width can vary as described with respect to the filters disclosed in the '972 patent.
(54) After convergence of strut portions 114a, 114b at joining region 114d, it transitions into elongated mounting strut portions 114c which form the flared mounting or anchoring region 130. The length of the strut portions 114c in the anchoring region 130 can vary, with increased/decreased length increasing the flexibility/rigidity of the struts. The thickness of the strut portions can also vary to affect flexibility/rigidity.
(55) The tubular portion 118 is preferably in the form of a retrieval hook 192. In an alternate embodiment, instead of a retrieval hook 102, a ball or groove can be provided engageable by the retrieval snare (not shown) for retrieval of the filter.
(56) Note that the tubular region 118 has a lumen 119 therethrough (see
(57) After exposure of the filter 100 by advancing the pusher 30 to eject the filter 100 or retracting the sheath 20 with the pusher 30 held stationary, or relative movement of both the pusher 30 and sheath 20, the pusher 30 and sheath 20 are removed, enabling the filter 100 to expand from its collapsed position of
(58) If it is later desired to remove the filter, the retrieval methods for the filter which are illustrated and described in detail in the '972 patent, such as a retrieval snare, can be utilized.
(59) If the filter 100 is more centered in the vessel, the retrieval snare is better adapted to access and engage (grasp) the retrieval region, e.g., the retrieval hook 192, of the filter 100. Also, if placement is more centered, removal can be easier because there will be less tissue ingrowth at the retrieval region.
(60) Although described for inserting a vessel filter, the pusher and sheath can be utilized to insert other implants, including vascular implants such as a stent or valve.
(61) While the above description contains many specifics, those specifics should not be construed as limitations on the scope of the disclosure, but merely as exemplifications of preferred embodiments thereof. Those skilled in the art will envision many other possible variations that are within the scope and spirit of the disclosure as defined by the claims appended hereto.