阅读说明：本技术 具有可释放的捕获特征的ivc过滤器回收系统 (IVC filter recovery system with releasable capture feature ) 是由 N.德比尔 F.贝金 K.哈尔登 T.鲁瓦尔卡巴 于 2015-12-10 设计创作，主要内容包括：本发明公开了具有可释放的捕获特征的IVC过滤器回收系统。由编织物制成的漏斗捕捉器型装置或系统用于捕获和回收或者替代地捕获和随后释放下腔静脉(IVC)过滤器或其他医疗装置。构思出了输送和/或回收装置、其中包括它们的套件、使用方法和制造方法。(The invention discloses an IVC filter recovery system with a releasable capture feature. Funnel trap type devices or systems made from braids are used to capture and retrieve or alternatively capture and subsequently release an Inferior Vena Cava (IVC) filter or other medical device. Delivery and/or recovery devices, kits including the same, methods of use, and methods of manufacture are contemplated.)

1. An apparatus for vascular medical device retrieval, the apparatus comprising:

an elongated sleeve; and

an elongate shaft received within the elongate sleeve, the shaft having a flexible distal extension comprising a braid, the distal extension being folded back inwardly at a distal opening to form a flap and a proximal opening,

wherein the proximal opening is sized to receive and pass a terminal interface of the medical device therethrough,

wherein the apparatus is adapted such that when the elongate sleeve is advanced beyond the distal extension, or when the distal extension is withdrawn into the elongate sleeve, an end interface of the medical device can be secured in a pocket defined by the flap and the unreturned portion of the distal extension,

wherein the apparatus is adapted to reverse the flap from an inward orientation to an outward orientation to release the end interface of the medical device, and

wherein the end interface of the medical device comprises a protuberance.

2. The apparatus of claim 1, wherein the distal extension comprises a braid.

3. The apparatus of claim 2, wherein the braid comprises nitinol with between 72 and 288 end counts and contains axial fibers.

4. The apparatus of claim 2, wherein at least an inner surface of the flap is coated with a coating to protect the braid from intrusion of an end interface of the medical device.

5. The apparatus of claim 4, wherein the coating comprises polyurethane.

6. The apparatus of claim 1, wherein the elongated sleeve comprises a catheter.

7. The apparatus of claim 1, wherein adapted to invert the flap is a pusher received within a lumen of the shaft.

8. The device of claim 7, wherein the pusher comprises a wire attached to the folded back extension.

9. The device of claim 7, wherein the pusher comprises a piston including a sleeve and an expandable distal section.

10. The apparatus of claim 9, wherein the piston further comprises a pull wire received within the sleeve of the piston and connected at a distal end for expanding the expandable distal section.

11. The apparatus of claim 10, wherein the expandable distal section comprises a braid.

12. A system comprising a vascular medical device, the system further comprising an apparatus for vascular medical device retrieval as claimed in any one of claims 1 to 11.

Technical Field

Embodiments described herein relate to retrieval devices or systems and methods for intravascular temporary Inferior Vena Cava (IVC) filters or other implants.

Background

Temporary IVC filters are placed much like permanent filters, but are designed so that they can be retrieved in a separate endovascular procedure, typically from the femoral or jugular vein approach. Most currently available temporary filters include a hook feature that can be utilized to capture and receive them within a catheter or sheath for removal by employing a goose-neck snare (goose-snare) or a multi-loop snare (multi-loop snare).

Although recovery is in principle a simple process, difficulties are often encountered in capturing the hook of the filter with the loop of the snare. This difficulty is exacerbated when the filter is tilted or improperly placed. Several filters are designed to avoid such orientation. However, this problem is still common because the device is not anchored in a stable manner into the IVC. In addition to blood clots, continued blood flow may disorient the filter within the IVC, making recapture difficult. Accordingly, there remains a need for improved recovery systems for filters.

Disclosure of Invention

The exemplary embodiments described herein address this and/or other needs, particularly in addressing any complexity experience during filter retrieval. In particular, the subject devices or systems include features that allow for the capture or retrieval and subsequent release of an Inferior Vena Cava (IVC) filter or other medical device, if desired. In other words, the subject device allows for the reversal of IVC filter capture when so-called "emergency measures" are required to avoid other complications.

The ability to release a trapped or hooked IVC filter is desirable in cases where the amount of tissue ingrowth with the filter is greater than expected. Other reasons why a (in a sense) reverse process is desirable in the filter recovery process may be expressed by those skilled in the art.

In the subject system, the inversion selection is both figurative and literal in terms of design operation. That is, features are provided for reconfiguring and inverting the flaps contained in the retrieval device that would otherwise be intended to capture the IVC filter. In the inverted state, a baffle in the recovery device is configured to hold the filter. When the flap is inverted (i.e., turned outward or outwardly), the filter is released or allowed to release.

In one embodiment, a push wire is incorporated into the design to facilitate avoiding an otherwise inverted flap configuration. The wire may include a pair of wires arranged side-by-side, the pair (or plurality) of wires twisted and arranged to form a wire cable, a portion of a conduit structure, or otherwise arranged.

In another embodiment, a separate piston or pushing element may be deployed through a lumen (optionally a central lumen) of the retrieval device, and then further expanded and further flap eversion achieved. In this example, the piston means may be provided separately and tracked through a cavity in the retrieval means when required for use. Alternatively, the piston may be incorporated or housed in the retrieval device as a kit or combination.

However, the delivery devices or retrieval devices of the subject of construction, including their kits (with and without assembly), methods of use and manufacture (including assembly of in vivo or in vitro components), are all included within the scope of the present disclosure. Some aspects are described above and a more detailed discussion is given in conjunction with the following figures.

Other systems, devices, methods, features and advantages of the subject matter described herein will be, or will become, apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, devices, methods, features and advantages be included within this description, be within the scope of the subject matter described herein, and be protected by the accompanying claims. The features of the exemplary embodiments should in no way be construed to limit the appended claims, unless these features are explicitly recited in the claims.

Drawings

The details of the subject matter set forth herein, both as to its structure and operation, can be understood in light of the accompanying drawings in which like reference numerals refer to like parts. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the subject matter. Moreover, all illustrations are intended to convey concepts, where relative sizes, shapes and other detailed attributes may be illustrated schematically rather than literally or precisely.

Fig. 1A and 1B are pictures of an exemplary embodiment of an IVC filter variation that may be used in the present system.

2A-2C are side views depicting an exemplary embodiment of a first recovery system including a reversible filter capture feature.

Fig. 3A and 3B are side sectional views depicting another exemplary embodiment of a recovery system including a piston for filter capture feature reversal.

Detailed Description

Before the present subject matter is described in detail, it is to be understood that this disclosure is not limited to particular exemplary embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.

All features, elements, components, functions, and steps described in relation to any embodiment provided herein are intended to be freely combinable with, and replaceable with, features, elements, components, functions, and steps from any other embodiment. If a particular feature, element, component, function, or step is described only in connection with one embodiment, it is to be understood that feature, element, component, function, or step can be used with each other embodiment described herein unless explicitly stated otherwise. Thus, this paragraph is at any time relied upon and literally supported by the antecedent and written support of claims for combining features, elements, components, functions and steps from different embodiments or replacing features, elements, components, functions and steps from one embodiment with features, elements, components, functions and steps of another embodiment, even though the following description does not explicitly state that such combination or substitution is possible in certain circumstances. The explicit specification of each possible combination and substitution is overly cumbersome, especially given that the permissibility of each such combination and substitution will be readily recognized by those of skill in the art upon reading this specification.

Fig. 1A shows a temporary IVC filter 10 of G Ü NTHER TULIP (Cook Medical, Inc.) with a hook 12 end interface for recycling. As shown in fig. 1B, the hook may be modified or replaced with a nubbed (nubbin-type) interface 22 for the IVC filter 20. The nubs 24 may include laser formed or weld formed protrusions or bumps on the extension 26 of the hub 28. Alternatively, filter recovery interface 22 may include a band (e.g., Pt marker band) mounted (e.g., by swaging, welding, gluing, etc.) on extension 26-however, an enlarged portion is created whose interaction with the rest of the system will be apparent in the figures below.

Fig. 2A provides a cross-sectional view of a distal end of a retrieval system 100 adapted to release or reversibly capture a medical device (e.g., filter 10 or 20). The system 100 includes a shaft 30 having a distal extension 40 in the form of a funnel trap structure made of a braided material. In use in the vasculature of a patient, the shaft is housed within an elongated sleeve 60 (which may be a commercially available catheter or a custom part of the overall system 100).

In various system architectures, the catheter or pusher shaft and/or sleeve 30 (and the piston described in detail below) may comprise a simple extrusion (e.g., PTFE, FEP, PEEK, PI, etc.), or may be constructed using conventional catheter construction techniques, and include a liner, braided support and jacket, a metal hypotube (hypotube), etc. The frame of the filter 10 or 20 may be constructed and/or otherwise constructed using conventional laser cutting and electropolishing techniques. In embodiments intended for tracking through a guiding/delivery catheter that does not incorporate a sheath, a loading sheath may be employed. Advantageously, any such loading sheath is detachable. Other typical percutaneous access devices (e.g., wires, etc.), valves, and other hardware may also be employed in embodiments.

The funnel trap structure 40 can be fabricated as a subassembly and attached to the catheter/pusher shaft. International patent application No. PCT/US14/42343 and U.S. patent application serial No. 14/569,500, each of which is incorporated herein by reference in its entirety for all purposes, detail the optional steps of manufacturing a preform for constructing the funnel trap portion of the final device. Generally, the above-described forming method is a forming method in which a heat-set (possibly multi-stage heat-set) preform is provided which is substantially cylindrical in shape and comprises an internally folded "flap" section. Thus, the preform resembles the subject device in its fully compressed state for catheter tracking. The preform is then expanded (e.g., in a tapered shape) to the desired "working" diameter and heat set accordingly. It may be heat set tapered and ready for installation, or it may be heat set tapered and deformed into a taper by installation into catheter body 30.

The braid from which the recovery system extension 40 is optionally made may comprise nitinol (preferably superelastic at body temperature), CoCr, stainless steel or another biocompatible material. The braid advantageously contains between 72 and 288 (more typically, between 96 or 144 and 192) wire "ends" in a one-over-one (or 1-to-1, 1-over-1), two-over-two (or 2-to-2, 2-over-2) or other pentium pattern (maypole pattern). For (superelastic) nitinol, the wire is advantageously between about 0.001 inches and about 0.003 inches in diameter. In this case, a compliant and relatively "smooth" substrate surface is provided, thereby building the flexible funnel trap architecture shown and described. The value of such a surface is in its atraumatic aspect and/or the ability to help guide the interface of the IVC filter into position for capture, even if it is in an off-angle orientation. To further assist in recapturing, the funnel trap structure may be selectively orientable.

The braid may also comprise so-called "axial" filaments. These can be used to increase column strength in the final formed device (column strength). The axial filaments may be bonded as it is formed in a/the pentadecan weave pattern, or added manually at a later time. Alternatively, (and as shown in fig. 2A), the funnel trap structure 40 may include an inserted support member as further described in U.S. provisional patent application serial No. 62/091,433, which is incorporated herein by reference in its entirety for all purposes.

The so-called "funnel trap" structure or extension 40 may be generally frusto-conical in shape as shown or otherwise configured. With an outer conical shape (i.e., a triangular shape in cross-section), this configuration is highly supportive of any necessary or desired tissue discrimination (tissue discrimination) that may need to occur to release a seated filter. However, the device may be curved or otherwise configured outwardly along its sides.

Fig. 2A shows further structural options and details. Here, the inner and outer braided layers 42/42' are heat set using conventional techniques in funnel shapes (e.g., in an oven, salt pan, etc.) where the distal bends 44 in the braided wire form outer edges 46, 48 with large (larger) distal openings and the convergence at the inner bends 50 form inner edges 52 with small (smaller) proximal side openings 54. In other words, the braid used to construct the funnel-shaped trap is folded back at the distal opening (e.g., with flap 56) to provide a more proximal opening.

Importantly, the distal edge opening 48 is larger than the more proximal edge opening 54 to operate to direct the filter engagement feature or enlargement 12/24 into the pocket 58 adjacent and/or radially adjacent flap 56 and subsequently lock onto the advancing sleeve 60. Initial capture of the filter 10 in this manner is shown in fig. 2B.

To help ensure capture, the sleeve 60 may be advanced completely beyond the catcher section 40 before being withdrawn into a separate catheter, as shown in the figure. In other words, the sleeve 60 (whether a system or device-integrated sleeve or in-situ catheter) advanced over the funnel section 40 "closes the trap" and securely captures the implant to be retrieved. Otherwise, the shaft 30 may be withdrawn until the implant is pulled into the entry catheter originally used to introduce the system 100. Any or all of such activities may be visualized perspectively by a physician through a marker feature incorporated in the system 100.

It is noted that system 100 may be used the same as when capturing filters 20 with more nubs or nodes 24 terminating interfaces. In such a case, the capture reversal feature detailed below may not be required for releasing the implant tip. However, with such a feature, a solution is provided to handle a wider range of filters and once implemented, the capture needs to be released.

With respect to the subject catch release or reversal feature, in the embodiment shown in fig. 2A-2C, these are connected with an inner shaft 62 and a push "wire" 64. In the illustrated construction (and fully labeled with the label in fig. 2B), the wire is looped around or through a portion of the edge 52 forming a "U" 66 secured by a band 68 (e.g., a crimped PT marker band). As shown in fig. 2C, as the lead 64 is advanced, secured to the braid, the tab portion 56 of the extension 40 may move from the inverted configuration to the upright configuration. This releases the hook 12 of the filter 10.

The action of ejecting or releasing the hook 12 is clearly apparent. Possibly accompanied by the withdrawal of the shaft 30, so that the hook can slide out of the inverted flap. Also, when the device is in the configuration shown in fig. 2B, flap 56 may incorporate a coating 70 (e.g., TICOFLEX polyurethane coating) on its inner surface to secure the braid against snagging or retention of hooks.

The system 100' in fig. 3A and 3B is similar to that described above, except that a more complex pusher 200 is substituted for the pusher wire 64. The pusher 200 may be received within the lumen 72 of the catheter body 30 (e.g., wire 64).

As shown, the pusher 200 may be considered or referred to as a "piston," which functions as shown. That is, pusher 200 is advanced within cavity 72 after it expands in funnel trap extension 30 of the system and serves to push flaps 56 outward to effect implant engagement feature release. During a medical procedure, the pusher may reside in the lumen 72 during introduction of the system 100'. Alternatively, if the physician determines that release of the captured implant 10 is somewhat desirable, it may be packaged separately and the package inserted and tracked "on demand" through the cavity 72.

In any case, the pusher 200 includes a sleeve 202 and an expandable distal section 204. The expandable distal section may comprise a braid as shown. A braid-actuated pull wire 206 for pulling from being pushed out and compressed, into being expanded, may be included within the sleeve. Otherwise, the braid (or other material such as a tube cut nitinol stent structure) may be heat set in the enlarged configuration to self-expand and attach to the distal end once out of the lumen.

In the variation shown in fig. 3A and 3B (i.e., using a braid-based section 204), the distal end of the braid may be secured to a wire 206 within a distal Pt marker band 208. Another marker band 210 may be provided at the proximal end of the expansible portion, securing the proximal end of the braidable article to the braided end to the sleeve or shaft 202. Thus, when the pull wire 206 is actuated, expansion and/or contraction of the section 204 (i.e., by observing actuation of the indicia) may be detected even if the material of the expandable portion is not itself see-through visible.

And (5) modifying.

The subject methods, including methods of use and/or manufacture, can be performed in any order of logically possible events, and in any recited order of events. The medical method may include any activity of hospital personnel associated with device provisioning, implant positioning, repositioning, retrieval and/or release.

Further, where a range of values is provided, it is understood that each intervening value, to the extent that there is no such stated, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the disclosure. Furthermore, it is also contemplated that any optional feature of the described embodiments may be set forth and claimed independently or in combination with any one or more of the features described herein.

Reference to a singular item includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms "a," "an," "said," and "the" include plural referents unless the context clearly dictates otherwise. In other words, use of the articles allows for "at least one" of the subject items in the description above as well as in the claims that follow. It is also noted that the claims may be drafted to exclude any optional element. Accordingly, this statement is intended to serve as antecedent basis for use of such exclusive terminology as "solely," "only," and the like in connection with the recitation of claim elements, or use of a "negative" limitation.

While the embodiments are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that these embodiments are not to be limited to the particular forms disclosed, but to the contrary, these embodiments are to cover all modifications, equivalents, and alternatives falling within the spirit of the disclosure. Furthermore, any feature, function, step, or element of the embodiments may be recited in or added to the claims, and the negative limitation of the scope of the claims is defined by features, functions, steps, or elements that are not within the scope.